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(HNSN) Enters Into Agreement With Investors to Receive up to $93 Million in Equity Financing

Company to Receive Upfront $39 Million Upon Closing

Hansen Medical Enters Into Agreement With Investors to Receive up to $93 Million in Equity Financing

Company to Receive Upfront $39 Million Upon Closing

MOUNTAIN VIEW, CA–(Marketwired – Jul 31, 2013) –  Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that, subject to closing conditions, it has entered into a securities purchase agreement for up to $93 million with Oracle Investment Management, leading medical device executive Jack W. Schuler, certain members of the Company’s Board of Directors, and other existing and new shareholders, including several former healthcare executives. Proceeds from this transaction will be used to support Hansen Medical’s efforts to commercialize the Magellan™ Robotic System, drive further adoption of the Sensei® Robotic System and strengthen operations across the Company.

The agreement is structured to provide up to $93 million before expenses. Hansen Medical would receive $35 million upon the closing of the purchase of shares of common stock at a per share price of $1.23. Investors would also purchase warrants to purchase approximately 34 million shares of common stock. All warrants will have a two-year term and will not be transferable. The purchase price for the warrants will be $0.125 for each warrant, totaling an additional $4 million of proceeds. Total gross proceeds to the Company from the initial sale of common stock and warrants will be approximately $39 million.

The warrants will be allocated into three equal tranches of approximately 11.4 million, and, if exercised, could yield the Company additional proceeds of up to $54 million. The Series A Warrants will have an exercise price of $1.23 per share and will be subject to mandatory exercise subsequent to Hansen Medical’s receipt of regulatory approval for the new 6F Magellan catheter in the U.S. The additional proceeds provided to the Company under this Series A Warrant would be approximately $14 million.

The Series B and Series C Warrants will have an exercise price of $1.50 per share, and $2.00 per share, respectively, but will not be subject to mandatory exercise. These warrants, if fully exercised, would provide additional proceeds to the Company of $17 million and $23 million, respectively.

Under the terms of the agreement, each investor will agree to a lockup such that they will not buy (other than through exercise of the Warrants) or sell any shares of common stock for a one year period following the closing date. Following the close of the transaction, Mr. Schuler will be granted a seat on the Company’s Board of Directors.

The closing of the transaction will be subject to customary closing conditions, including approval of the listing of the shares of common stock on the NASDAQ.

The securities offered will not be or have not been registered under the Securities Exchange Act of 1933, as amended, and may not be offered or sold in the U.S., absent registration or an applicable exemption from registration requirements.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events including the closing of the transaction. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” “goal,” “estimate,” “anticipates,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the expected closing of the private equity placement transaction and the anticipated receipt of regulatory approval for the new 6F Magellan catheter in the U.S. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: delays in satisfying or failure to satisfy closing conditions for the financing, including obtaining Nasdaq clearance for the issuance of the shares and warrants in the financing; failure to achieve the milestone for mandatory exercise of the Series A Warrants; engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; the commercial viability of our products in the electrophysiology and vascular markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 filed with the SEC on May 10, 2013 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), Sensei, Artisan, Artisan Extend and Lynx are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.

Investor Contacts:
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800

FTI Consulting, Inc.
Brian Ritchie
212.850.5683
Email Contact

John Capodanno
212.850.5705
Email Contact

Wednesday, July 31st, 2013 Uncategorized Comments Off on (HNSN) Enters Into Agreement With Investors to Receive up to $93 Million in Equity Financing

(EHTH) Federal Government Signs Web-Broker Entity Agreement With eHealth

Paves the Way for eHealth to Help Enroll Uninsured Subsidy-Eligible Individuals in 36 States; eHealth CEO Gary Lauer Says: “We Now Hope That the 14 Remaining States Will Follow the Leadership of the Federal Government and Allow Their Subsidy-Eligible Residents the Same Opportunity”

Federal Government Signs Web-Broker Entity Agreement With eHealth

Paves the Way for eHealth to Help Enroll Uninsured Subsidy-Eligible Individuals in 36 States; eHealth CEO Gary Lauer Says: “We Now Hope That the 14 Remaining States Will Follow the Leadership of the Federal Government and Allow Their Subsidy-Eligible Residents the Same Opportunity”

MOUNTAIN VIEW, CA–(Marketwired – Jul 31, 2013) – eHealth, Inc. (NASDAQ: EHTH), the nation’s leading online health insurance exchange for individual and family health insurance, today announced that it has reached a written agreement with the U.S. government on key requirements that will set the stage for eHealth to help enroll tax-subsidy-eligible residents of 36 states in qualified health insurance plans under the Affordable Care Act (ACA).

The agreement is between eHealth as a “web-broker entity” (WBE) and the federal government’s Centers for Medicare and Medicaid Services (CMS), which supervises the federal government’s health insurance, web-based exchange, called the “Federally Facilitated Exchange” or “FFE.” Under a specific regulation issued by CMS on March 27, 2012, WBEs such as eHealth, after reaching agreement with CMS or individual states operating their exchanges, are authorized to help enroll tax-subsidy-eligible individuals under the Affordable Care Act.

The FFE agreement just signed by eHealth and CMS allows eHealth to access the Federal electronic data hub, which is necessary for a determination of tax subsidy eligibility and the amount of a subsidy. It also provides for additional strict consumer- and privacy-protective requirements and standards beyond those spelled out in regulations. An additional agreement encompassing the federal requirements for agents and brokers will still need to be signed by eHealth and CMS in order for eHealth to begin enrolling subsidy-eligible individuals into qualified health plans made available by the ACA.

“The agreement announced today is an important step in eHealth’s efforts to help deliver on the goals of the Affordable Care Act by giving many Americans the ability to utilize their subsidies when they enroll in quality health insurance at eHealth.com,” said Gary Lauer, Chief Executive Officer and Chairman of eHealth, Inc.

“We applaud CMS for embracing public-private partnerships with marketplaces like eHealth to establish a framework for secure, streamlined and cost-free enrollment of tax-subsidy-eligible people,” Lauer said.

“We now hope that the 14 States and DC that are working hard to develop their own health insurance exchanges will follow the leadership of the federal government and allow their subsidy-eligible residents the same opportunity that is expected to exist in the 36 other states to utilize resources like eHealth.com for enrollment. This will simply result in more enrollments, which is crucial to the Affordable Care Act’s success, and at the same time save the government taxpayer money.”

Lauer said that eHealth has offered every one of these states technical assistance to enable eHealth to sign a similar agreement and be ready to take advantage of eHealth and other WBEs to supplement their enrollment capacity.

“If there are technical concerns by individual states,” Lauer pointed out, “I am confident we can quickly help resolve them.”

The agreement signed by eHealth is with the Centers for Medicare and Medicaid Services (CMS), the federal government agency that is responsible for the management and oversight of the FFE and the Federal electronic data-hub. The data-hub allows the government exchanges to determine tax subsidy eligibility and subsidy amounts. The WBE would receive limited data sufficient to serve as a web-based platform enabling insurance carriers to enroll tax-subsidy-eligible individuals in “qualified health plans,” as defined under the Affordable Care Act. All WBEs must abide by strict consumer-protective and privacy and security requirements and standards under the agreement with CMS in order to be allowed to assist the federally facilitated exchanges in enrolling tax-subsidy-eligible individuals.

eHealth has enrolled over 3 million individuals in coverage since it sold the first health insurance policy online in 1998, approximately 40% of whom were uninsured before they came to eHealth.

About eHealth
eHealth, Inc. (NASDAQ: EHTH) is the parent company of eHealthInsurance, the nation’s first and largest private health insurance exchange where individuals, families and small businesses can compare health insurance products from leading insurers side by side and purchase and enroll in coverage online. eHealthInsurance offers thousands of individual, family and small business health plans underwritten by more than 200 of the nation’s leading health insurance companies. eHealthInsurance is licensed to sell health insurance in all 50 states and the District of Columbia.

eHealth, Inc. also provides powerful online and pharmacy-based tools to help seniors navigate Medicare health insurance options, choose the right plan and enroll in select plans online through its wholly-owned subsidiary, PlanPrescriber.com (www.planprescriber.com) and through its Medicare website www.eHealthMedicare.com.

Forward-Looking Statements
This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. These include statements regarding eHealth’s expectation that it will gain the ability to help enroll tax-subsidy eligible residents of 36 states in qualified health plans, the availability of the electronic data hub and the use of web-based brokers to enroll individuals through government-run health insurance exchanges, the utilization of resources like eHealth resulting in more enrollment and government savings, resolution of state exchange technical concerns and WBE receipt of data sufficient to enroll tax-subsidy eligible individuals in qualified health plans. These forward-looking statements are inherently subject to various risks and uncertainties that could cause actual results to differ materially from the statements made, including permission from state and federal governments to operate as a WBE, eHealth’s readiness to act as a WBE and the government’s readiness to permit enrollment from WBEs, eHealth’s ability to comply with the terms of its WBE related agreements and with laws and regulations related to acting as a WBE, the terms of additional agreements relating to eHealth acting as a WBE, technical difficulties and integration issues in connection with the implementation of WBE capability to enroll individuals in qualified health plans and the effectiveness of eHealth in enrolling individuals into qualified health plans. Other risks and uncertainties that can affect actual results are included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2012 and our most recent Quarterly Report on Form 10-Q, which are on file with the SEC and are available on the investor relations page of the Company’s website at http://www.ehealthinsurance.com and on the Securities and Exchange Commission’s website at www.sec.gov. All information provided in this press release is as of the date of this press release, and we undertake no duty to update this information unless required by law.

For eHealth, Inc. media inquiries, please contact:
Brian Mast
Vice President, Communications
eHealth, Inc.
(650) 210-3149
brian.mast@ehealth.com

Nate Purpura
Director of Public Relations
eHealth, Inc.
(650) 210-3115
nate.purpura@ehealth.com

For investor inquiries, please contact:
Kate Sidorovich, CFA
Vice President, Investor Relations
650-210-3111
kate.sidorovich@ehealth.com

Wednesday, July 31st, 2013 Uncategorized Comments Off on (EHTH) Federal Government Signs Web-Broker Entity Agreement With eHealth

(MGAM) Q3 Revenue Up 19%, New Quarterly Record of $48.1M

Multimedia Games Holding Company, Inc. (Nasdaq: MGAM) (“Multimedia Games” or the “Company”) today reported operating results for its fiscal 2013 third quarter ended June 30, 2013, as summarized below:

 

Summary of 2013 Q3 Results(In millions, except per share and unit data)
Three Months Ended
June 30,
2013 2012
Revenue $ 48.1 $ 40.5
EBITDA (1) $ 25.0 $ 19.2
Operating income (2) $ 14.0 $ 7.7
Net income (2) $ 8.4 $ 7.2
Diluted earnings per share (2) $ 0.28 $ 0.25
Pro-forma diluted earnings per share (3) $ 0.28 $ 0.19
New units sold 647 543
Domestic participation installed units:
Average 11,946 9,981
Quarter-end 12,163 10,149
(1) EBITDA is defined as net income before net interest expense, income taxes, depreciation, amortization and accretion of contract rights. A reconciliation of EBITDA to net income, the most comparable Generally Accepted Accounting Principles (“GAAP”) financial measure, can be found attached to this release.
(2) Operating income, net income and diluted earnings per share (“EPS”) for the three month period ended June 30, 2013, reflects a change in the depreciable lives for the Company’s gaming operations equipment as described later in this release.
(3) Pro-forma diluted earnings per share for the three month period ended June 30, 2012, reflects the following adjustments: (i) a tax expense rate of 38.7%, representing the effective tax rate for the fiscal 2013 third quarter, which results in a $0.09 per diluted share reduction from the reported results; and, (ii) an estimated $0.03 benefit to fully diluted EPS related to the change in depreciable lives of gaming operations equipment (which is described in more detail below).
Three Months Ended
June 30,
2013 2012
Diluted EPS as reported (2) $ 0.28 $ 0.25
Pro-forma at 38.7% tax rate (0.09 )
Normalize depreciation, net of tax 0.03
Pro-forma diluted EPS (3) $ 0.28 $ 0.19

Patrick Ramsey, President and Chief Executive Officer of Multimedia Games, commented, “Our record quarterly revenue and overall strong financial performance reflects our ongoing success in creating great games that resonate with customers. We continue to expand the Company’s total addressable market while simultaneously achieving growth in existing markets. We delivered quarterly revenue of over $48 million as we deployed over 1,000 new revenue units for the fourth consecutive quarter, with products placed in 21 states, and generated operating margins that continue to be at the high end of our industry peer group, coming in at 29.1% of revenues. Combined, these factors enabled us to generate $14 million in free cash flow (definition provided below). Further, the operating leverage in our business was evident in the quarter as EBITDA growth of 30% outpaced the approximately 19% increase in revenue.

“During the quarter we further expanded our addressable markets as Nevada sales and placements began in earnest and we generated our first sales in New Jersey. Our MForce™ gaming platform completed additional Nevada technical field trials, allowing us to address the majority of the potential customers in the state. In addition, we have expanded our portfolio of approved games in Nevada to 22 titles, including TournEvent®, which received final approvals late in the fiscal third quarter. During the fiscal 2013 third quarter, we sold or placed 102 games in Nevada and we expect to continue our penetration into this important market.

“Gaming operations growth also continued as we added 451 net new units to the installed base, including 376 units outside of Oklahoma. Notably, our base of non-Oklahoma premium games increased by 208 units in the quarter as we ended the quarter with 713 premium units installed in a total of 18 markets. Additionally, with the increased geographic diversification of our products, our average revenue per day continues to rise as yields rose 3.0% year over year.

Ramsey concluded, “Awareness of our products has never been higher as we leverage the solid performance of our games in existing markets into new large market opportunities such as Nevada, Illinois and New Jersey. Our games continue to be met with strong acceptance from players and they bring a strong value proposition to our customers. We believe this combination will lead to further growth of our gaming operations and game sales businesses.”

Summary of Fiscal 2013 Third Quarter Operating Results

Multimedia Games’ fiscal 2013 third quarter revenue rose 18.9%, or $7.6 million, to $48.1 million, compared to revenue of $40.5 million in the fiscal 2012 third quarter. Fiscal 2013 third quarter revenue included approximately $34.3 million from gaming operations and approximately $13.5 million from gaming equipment and system sales, compared with $28.4 million from gaming operations and $11.7 million from gaming equipment and system sales in the year-ago period.

Gaming operations revenue in the fiscal 2013 third quarter grew 20.7% to $34.3 million driven by broad-based growth in the Company’s installed base of participation units. Multimedia Games’ domestic ending installed base increased by 2,014 units, or 19.8%, from the fiscal 2012 third quarter and by 451 units, or 3.9%, on a quarterly sequential basis. The installed base grew in substantially all the Company’s existing markets, including Oklahoma. Included in the quarter-end participation base were 713 premium participation units deployed outside of Oklahoma, an increase of 208 units, or 41.2%, on a quarterly sequential basis. Fiscal 2013 third quarter gaming operations revenue also benefited from a $0.4 million year-over-year rise in revenues related to the Company’s operation of the central determinant system for the New York Lottery.

Gaming equipment and system sales in the fiscal 2013 third quarter increased 15.3% to $13.5 million, from $11.7 million in the prior-year period. During the quarter, the Company recorded revenue of $12.4 million related to the sale of 647 new units and $0.8 million in revenue related to parts and equipment sales, compared to $10.4 million in revenue related to the sale of 543 new units and $0.7 million related to parts and equipment sales in the year-ago period. Multimedia Games sold units into 15 markets, including its first sales to casinos in New Jersey. The Company’s top three markets for unit sales in the quarter – Washington, Louisiana and Nevada – accounted for a total of 302 units sold. There was $0.2 million and $0.6 million of deferred revenues for the sale of player stations and a system in a prior-year period recognized in the fiscal 2013 and fiscal 2012 third quarter periods, respectively.

Other revenue, primarily comprised of service revenue, was approximately $0.3 million and $0.4 million in the fiscal 2013 and fiscal 2012 third quarter periods, respectively.

Total operating costs and expenses for the fiscal 2013 third quarter rose by $1.4 million, or 4.3%, to $34.1 million driven primarily by the increase in sales and placements of the Company’s gaming units and higher selling, general and administrative (“SG&A”) costs, partially offset by lower depreciation and amortization reflecting the Company’s decision to change the depreciation schedule for its gaming operations equipment, as previously reported. Total cost of goods sold increased by $1.1 million due to the increase in the number of units sold and the additions to the installed base of participation games. SG&A expenses rose 6.2%, or $0.7 million, to $12.0 million, primarily reflecting higher salary and benefit costs related to the Company’s ongoing entrance into new markets and jurisdictions. SG&A for the fiscal 2013 and fiscal 2012 third quarter periods includes non-cash stock compensation costs of approximately $1.0 million and $1.2 million, respectively. Depreciation and amortization was $8.9 million in the fiscal 2013 third quarter compared to $9.5 million in the prior-year period, primarily reflecting the previously disclosed change in the depreciable lives for gaming operations equipment from 36 months to 48 months, effective as of October 1, 2012. Research and development expenses was $4.1 million in the fiscal 2013 third quarter compared to $3.9 million in the prior-year period.

Operating income rose to $14.0 million and operating margins improved to 29.1% in the fiscal 2013 third quarter compared to 19.1% in the year-ago period, driven by the rise in revenue significantly outpacing the increase in total operating expenses as well as the continued increase in the mix of high-margin recurring revenue. For the fiscal 2013 third quarter, Multimedia Games reported net income of $8.4 million, or $0.28 per diluted share, compared to net income of $7.2 million, or $0.25 per diluted share, in the fiscal 2012 third quarter. Net income and diluted earnings per share for the fiscal 2013 third quarter reflect a tax expense rate of 38.7% while net income and diluted earnings per share in the prior-year period reflect a tax expense rate of 5.9%.

Balance Sheet Review

Multimedia Games ended the fiscal 2013 third quarter with $92.5 million in cash and net cash (total cash in excess of total debt) of $62.0 million, versus net cash of $40.5 million and $33.6 million as of September 30, 2012, and June 30, 2012, respectively. The Company generated free cash flow of $14.0 million in the quarter ended June 30, 2013, compared to $7.3 million in the year-ago period. While capital expenditures fell to $11.1 million from $12.3 million a year ago, the Company continued to invest in its installed base during the quarter.

In the third quarter of fiscal 2013, the Company repurchased approximately 56,000 shares of its common stock at an average price of $20.87 per share, excluding commissions, for total consideration of approximately $1.2 million. As of June 30, 2013, the Company had approximately $35.2 million remaining under its existing $40.0 million share repurchase authorization which was announced in November 2012. Since December 2010, the Company has repurchased approximately 2.5 million shares of its common stock.

Adam Chibib, Chief Financial Officer, commented, “The popularity of our award-winning products and their growing success in the marketplace continue to strengthen our balance sheet and drive strong free cash flow. We also continue to allocate and reinvest capital into our business to effectively enter new markets, efficiently serve existing markets and create great products that attract customer and player attention. Based on the strong financial performance of the first nine months of the fiscal year, we are raising our fiscal 2013 diluted EPS outlook to a range of $1.07 to $1.10 from our prior $0.98 to $1.02 range.”

Updated Fiscal 2013 Outlook

Multimedia Games now forecasts fiscal 2013 revenues in the range of $187.7 to $190.3 million, representing total year-over-year revenue growth of approximately 20.2% to 21.9%. The revised revenue growth forecast assumes unit sales to range from 700 to 800 units in the fiscal 2013 fourth quarter as well as a quarterly sequential increase in the installed base. Fiscal 2013 revenue guidance also includes the previously disclosed early fourth quarter reduction in revenue share percentage on approximately 1,000 units installed at the WinStar World Casino and Resort in Oklahoma which the Company expects will impact fiscal fourth quarter diluted EPS by $0.01. The current unit sales and installed base growth forecast for fiscal 2013 includes an expectation for a measured level of unit deployments in Nevada, New Jersey and Illinois in the fourth quarter as Multimedia Games continues to build its library of approved games in these jurisdictions.

The Company now expects to generate EBITDA, a non-GAAP financial measure, of $95.1 to $96.0 million in fiscal 2013, representing growth of approximately 33.8% to 35.0% over total fiscal 2012 EBITDA of $71.1 million.

Revised Fiscal 2013 Guidance(In millions, except per-share)
Twelve Months Ended
September 30, 2013
Revised Prior
Guidance Guidance((1))
Revenue $ 187.7-190.3 $ 183.2-185.6
EBITDA $ 95.1-96.0 $ 90.0-92.0
Diluted earnings per share $ 1.07-1.10 $ 0.98-1.02
(1) Represents Company guidance for fiscal 2013 provided on April 30, 2013.

Operating margins for the fiscal 2013 fourth quarter are expected to decline on a quarterly sequential basis to a range of 25% to 26% due to higher marketing costs in the quarter related to higher spending for G2E, the annual industry trade show. The Company currently expects its tax rate in the fourth quarter to be 36% to 38% and expects the full year tax rate to range from 36% to 37% compared to a benefit of 11.4% in fiscal 2012. As a result, Multimedia Games now expects to report fiscal 2013 diluted EPS of $1.07 to $1.10, representing a year-over-year increase of approximately 52.9% to 57.1% over fiscal 2012 pro-forma diluted EPS as adjusted for the new depreciation schedule and when applying a 37.0% tax rate for fiscal 2012, as set forth in the table below.

Revised Fiscal 2013
Fiscal 2012 Guidance
EPS Reconciliation: Low High
As reported $ 0.96
Pro-forma at 37.0% tax rate (0.41 )
Impact of change in depreciation, net of tax 0.15
Adjusted, Pro-forma EPS $ 0.70 $ 1.07 $ 1.10

Multimedia Games cautions that market dynamics are constantly changing and as such, actual results could vary materially from the expectations noted above based on various factors, such as changes in the Company’s markets, operations, regulatory requirements, and its estimates and assumptions. See the risk factors in our publicly-filed Form 10-K’s and subsequent filings and other items as more fully described in the section below titled “Cautionary Language.”

2013 Third Quarter Conference Call and Webcast

Multimedia Games is hosting a conference call and webcast today, July 30, 2013, beginning at 9:00 a.m. ET (8:00 a.m. CT). Both the call and the webcast are open to the general public. The conference call number is 720-545-0001 (domestic or international). Please call five minutes prior to the presentation to ensure that you are connected.

Interested parties may also access the conference call live on the Internet at http://ir.multimediagames.com/events.cfm. Approximately two hours after the call has concluded, an archived version of the webcast will be available for replay at the same location.

Non-GAAP Financial Measures

See definitions of EBITDA, net cash, free cash flow, and pro-forma diluted earnings per share included in the discussion of Non-GAAP financial measures below.

About Multimedia Games Holding Company, Inc.

Through its wholly owned subsidiary, Multimedia Games Holding Company, Inc. (“Multimedia Games”) develops and distributes gaming technology. The Company is a creator and supplier of comprehensive systems, content and electronic gaming units for Native American gaming markets, as well as for commercial casinos and charity and international bingo markets. Revenue is primarily derived from gaming units installed on revenue-sharing arrangements. Multimedia Games also supplies the central determinant system for the video lottery terminals (“VLTs”) installed at racetracks in the State of New York. The company is focused on pursuing market expansion and new product development for Class II, Class III and VLT markets. Please visit www.multimediagames.com, twitter.com/MultimediaGames or facebook.com/MultimediaGames, where Multimedia Games discloses important information about the company, its sales, and its business.

Cautionary Language

This press release contains forward-looking statements based on Multimedia Games’ current expectations and projections, which are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. The words “believe”, “expect”, “continue”, “intend”, “plan”, “seek”, “estimate”, “project”, “may”, or the negative or other variations thereof or comparable terminology as they relate to Multimedia Games and its products, plans, and markets are intended to identify such forward-looking statements. All forward-looking statements are based on current expectations and projections of future events.

These forward-looking statements reflect the current views, models, and assumptions of Multimedia Games, and are subject to various risks and uncertainties that cannot be predicted or qualified and could cause actual results in Multimedia Games’ performance to differ materially from those expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to, the ability of Multimedia Games to expand and maintain its addressable markets; maintain strategic alliances; increase unit placements, installations or its installed-base; grow its revenue, gaming operations or game sales businesses; garner new market share; secure new licenses and game approvals in new and current jurisdictions, including Nevada and New Jersey; successfully develop or place proprietary product such as premium games; comply with regulations; have its games met with approval by customers or players; or reinvest capital. Please refer to the Company’s most recent Form 10-K and subsequent filings with the Securities and Exchange Commission for a further discussion of risks and uncertainties. All forward-looking statements made herein are qualified by these cautionary statements and there can be no assurance that the actual results, events or developments referenced herein will occur or be realized. Readers are cautioned that all forward-looking statements speak only to the facts and circumstances present as of the date of this press release. Multimedia Games expressly disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONDENSED CONSOLIDATED BALANCE SHEETS As of June 30, 2013 and September 30, 2012

(In thousands, except share and per-share amounts)

(Unaudited)

June 30, September 30,
ASSETS 2013 2012
CURRENT ASSETS:
Cash and cash equivalents $ 92,484 $ 73,755
Accounts receivable, net of allowance for doubtful accounts of $340 and $266, respectively 24,005 17,503
Inventory 9,592 7,083
Current portion of notes receivable, net 2,076 8,024
Deferred tax asset 8,248 8,248
Prepaid expenses and other 4,044 6,837
Total current assets 140,449 121,450
Property and equipment and leased gaming equipment, net 73,668 57,924
Intangible assets, net 36,168 37,664
Long-term portion of notes receivable, net 4,910 733
Deferred tax asset, less current portion 1,870 2,418
Value added tax receivable, net of allowance of $718 and $722, respectively 2,860 3,511
Other assets 2,181 2,275
Total assets $ 262,106 $ 225,975
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current portion of long-term debt $ 3,700 $ 3,700
Accounts payable and accrued liabilities 29,978 30,192
Federal and state income tax payable 6,096
Deferred revenue 236 483
Total current liabilities 40,010 34,375
Long-term debt, less current portion 26,825 29,600
Long-term deferred tax liability 6,320 6,320
Other long-term liabilities 511 660
Total liabilities 73,666 70,955
Commitments and contingencies
Stockholders’ equity:
Preferred stock:
Series A, $0.01 par value, 1,800,000 shares authorized, no shares issued and outstanding
Series B, $0.01 par value, 200,000 shares authorized, no shares issued and outstanding
Common stock, $0.01 par value, 75,000,000 shares authorized, 37,364,863 and 36,296,027 shares issued, and 28,948,783 and 28,183,549 shares outstanding, respectively 374 363
Additional paid-in capital 120,764 107,751
Treasury stock, 8,416,080 and 8,112,478, respectively, common shares at cost (66,886 ) (62,048 )
Retained earnings 134,188 109,283
Accumulated other comprehensive loss, net (329 )
Total stockholders’ equity 188,440 155,020
Total liabilities and stockholders’ equity $ 262,106 $ 225,975
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the Three and Nine Months Ended June 30, 2013 and 2012(In thousands, except per-share amounts)

(Unaudited)

Three Months EndedJune 30, Nine Months EndedJune 30,
2013 2012 2013 2012
REVENUES:
Gaming operations $ 34,314 $ 28,419 $ 97,694 $ 82,363
Gaming equipment and system sales 13,451 11,665 40,242 31,372
Other 340 380 1,043 1,056
Total revenues 48,105 40,464 138,979 114,791
OPERATING COSTS AND EXPENSES:
Cost of gaming operations revenue (1) 3,704 3,167 10,359 9,162
Cost of equipment and system sales 5,461 4,894 17,027 13,227
Selling, general and administrative expenses 12,012 11,308 34,930 34,332
Research and development 4,053 3,852 12,316 11,162
Amortization and depreciation 8,900 9,510 25,007 28,712
Total operating costs and expenses 34,130 32,731 99,639 96,595
Operating income 13,975 7,733 39,340 18,196
OTHER INCOME:
Interest income 85 308 399 1,320
Interest expense (277 ) (330 ) (867 ) (1,059 )
Other income (expense) (10 ) 33 1,038
Income before income taxes 13,783 7,701 38,905 19,495
Income tax benefit (expense) (5,334 ) (452 ) (14,000 ) 354
Net income $ 8,449 $ 7,249 $ 24,905 $ 19,849
Basic earnings per common share $ 0.29 $ 0.26 $ 0.87 $ 0.72
Diluted earnings per common share $ 0.28 $ 0.25 $ 0.82 $ 0.69
Shares used in earnings per common share:
Basic 28,960 27,564 28,781 27,621
Diluted 30,710 29,275 30,487 28,940
(1) Cost of revenues exclude depreciation and amortization of gaming equipment, content license rights and other depreciable assets, which are included separately in the amortization and depreciation line item.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFor the Nine Months Ended June 30, 2013 and 2012

(In thousands)

(Unaudited)

2013 2012
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $ 24,905 $ 19,849
Adjustments to reconcile net income to cash provided by operating activities:
Amortization and depreciation 25,007 28,712
Accretion of contract rights 6,034 5,752
Share-based compensation 2,850 2,668
Other non-cash items 1,401 1,052
Interest income from imputed interest (321 ) (1,084 )
Deferred income taxes 548
Changes in operating assets and liabilities (182 ) 247
NET CASH PROVIDED BY OPERATING ACTIVITIES 60,242 57,196
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions of property and equipment and leased gaming equipment (36,623 ) (31,811 )
Acquisition of intangible assets (6,605 ) (4,283 )
Advances under development and placement fee agreements (8,535 ) (13,815 )
Repayments under development agreements 7,689 11,933
NET CASH USED IN INVESTING ACTIVITIES (44,074 ) (37,976 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of stock options, warrants and related tax benefit 10,174 6,828
Principal payments of long-term debt (2,775 ) (2,775 )
Proceeds from capital leases 548
Principal payments of capital leases (67 )
Purchase of treasury stock (4,838 ) (1,884 )
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES 2,561 2,650
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS (262 )
Net increase in cash and cash equivalents 18,729 21,608
Cash and cash equivalents, beginning of period 73,755 46,710
Cash and cash equivalents, end of period $ 92,484 $ 68,318

Reconciliation of GAAP to Non-GAAP measures:

This press release and accompanying schedules provide certain information regarding (i) EBITDA, (ii) net cash, (iii) free cash flow, and (iv) pro-forma diluted earnings per share, all of which may be considered non-GAAP financial measures under the rules of the Securities and Exchange Commission. The non-GAAP financial measures included in the press release are reconciled to the corresponding GAAP financial measures below, or above in this release for pro-forma diluted earnings per share, as required under the rules of the Securities and Exchange Commission regarding the use of non-GAAP financial measures. We define (i) EBITDA as net income before net interest expense, income taxes, depreciation, amortization and accretion of contract rights, (ii) net cash as cash and cash equivalents less long-term debt, (iii) free cash flow as cash flow from operating activities less the acquisition of property and equipment and leased gaming equipment, and (iv) pro-forma diluted earnings per share reflects a tax expense rate adjustment and an estimate for a change in depreciable lives of gaming operations equipment. EBITDA, net cash, free cash flow and pro-forma diluted earnings per share are not recognized financial measures under GAAP, but we believe that each is useful in measuring our operating performance. We believe that the use of the non-GAAP financial measure EBITDA enhances an overall understanding of the Company’s past financial performance, and provides useful information to the investor by comparing our performance across reporting periods on a consistent basis and the use of EBITDA by other companies in the gaming equipment sector as a measure of performance. We believe that the non-GAAP measures of net cash, free cash flow and pro-forma diluted earnings per share provide useful information to investors as each enhances the overall understanding of our operating performance.

Investors should not consider these measures in isolation or as a substitute for net income, operating income, or any other measure for determining the Company’s operating performance that is calculated in accordance with GAAP. In addition, because these measures are not calculated in accordance with GAAP, they may not necessarily be comparable to similarly titled measures employed by other companies.

For the Three Months Ended June 30,
2013 2012
(in thousands)
Net income $ 8,449 $ 7,249
Add back:
Amortization and depreciation 8,900 9,510
Accretion of contract rights(1) 2,080 1,923
Interest expense (income), net 192 22
Income tax expense 5,334 452
EBITDA $ 24,955 $ 19,156
1) “Accretion of contract rights” relates to the amortization of intangible assets for development projects. These amounts are recorded net of revenues in the Consolidated Statements of Operations.
Net Cash
As of
June 30, 2013 September 30, 2012 June 30, 2012
Cash and cash equivalents $ 92,484 $ 73,755 $ 68,318
Less:
Long-term debt (30,525 ) (33,300 ) (34,706 )
Net cash $ 61,959 $ 40,455 $ 33,612
Free Cash Flow
For the three months ended
June 30, 2013 June 30, 2012
Net cash provided by operating activities $ 25,180 $ 19,561
Less:
Acquisition of property and equipment and leased gaming equipment (11,089 ) (12,279 )
Free cash flow $ 14,091 $ 7,282

Please see definition of “pro-forma diluted earnings per share” at the beginning of this release.

Tuesday, July 30th, 2013 Uncategorized Comments Off on (MGAM) Q3 Revenue Up 19%, New Quarterly Record of $48.1M

(GTLS) $50 Million Plus Contract to Provide LNG Equipment to PetroChina

CLEVELAND, July 30, 2013 (GLOBE NEWSWIRE) — Chart Industries, Inc. (Nasdaq:GTLS), a leading independent global manufacturer of highly engineered equipment used in the production, distribution, storage, and end-use of hydrocarbon and industrial gases, today announced that its Distribution & Storage (“D&S”) business in China has been awarded a contract to provide self-contained liquefied natural gas (“LNG”) station modules to Kunlun Energy Investment, a wholly owned subsidiary of PetroChina’s Kunlun Energy.

The contract value of this order is in excess of $50 million and is in addition to the $45 million PetroChina order the Company received and announced in April 2013. “This is the third major award from PetroChina in the last several quarters which highlights their continuing commitment to the LNG infrastructure build-out in China and we are very pleased they have chosen Chart again in recognition of our quality and product capabilities,” stated Tom Carey, President of Chart’s D&S Group. This new order is not included in the Company’s second quarter 2013 orders and backlog.

Certain statements made in this news release are or imply forward-looking statements, such as statements concerning business plans, objectives, market trends, future revenue, performance, and other information that is not historical in nature. These statements are made based on Chart’s expectations concerning future events and are subject to factors and uncertainties that could cause actual results to differ materially, such as cyclicality of product markets and vulnerability of markets to economic downturns, a delay or reduction in customer purchases, competition, fluctuations in energy prices or changes in government energy policy, management of fixed-price contract exposure, reliance on the availability of key supplies and services, pricing and availability of raw materials, modification or cancellation of customer contracts, fluctuations in foreign currency exchange rates, and economic, political, business and market risks associated with international transactions. For a discussion of these and additional factors that could cause actual results to differ from forward-looking statements, see Chart’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) in Chart’s most recent Annual Report on Form 10-K. Chart undertakes no obligation to update or revise any forward-looking statement.

Chart is a leading independent global manufacturer of highly engineered equipment used in the production, storage and end-use of hydrocarbon and industrial gases. The majority of Chart’s products are used throughout the liquid gas supply chain for purification, liquefaction, distribution, storage and end-use applications, the largest portion of which are energy-related. Chart has domestic operations across the United States and an international presence in Asia, Australia and Europe.

For more information: http://ir.chartindustries.com/.

CONTACT: Ken Webster
         Vice President, Chief Accounting
         Officer and Controller
         216-626-1216
         ken.webster@chartindustries.com
         or
         Chris Rioux
         Manager of Investor Relations and
         Financial Planning
         216-626-1216
         chris.rioux@chartindustries.com
Tuesday, July 30th, 2013 Uncategorized Comments Off on (GTLS) $50 Million Plus Contract to Provide LNG Equipment to PetroChina

(LCAV) Second Quarter Financial Results Feature EPS of $0.02

CINCINNATI, July 30, 2013 /PRNewswire/ — LCA-Vision Inc. (NASDAQ: LCAV), a leading provider of laser vision correction services under the LasikPlus® brand, today announced financial and operating results for the three and six months ended June 30, 2013.

Second Quarter 2013 Financial and Operating Highlights (all comparisons are with the second quarter of 2012)

  • Revenues were $22.6 million compared with $25.2 million; adjusted revenues were $22.4 million compared with $24.5 million.
  • Procedure volume was 12,994 compared with 14,415.
  • Medical professional and license fees decreased by $1.6 million to $4.2 million from $5.8 million. The decrease resulted from lower procedure volume coupled with lower laser fees. Laser fees were favorably impacted by the company’s purchase in April 2013 of its previously leased excimer lasers, which provided a lower per-procedure fee for all procedures performed in 2013 with this equipment, as well as for enhancement costs.
  • Vision center direct costs decreased by $2.1 million to $9.4 million from $11.5 million. The decrease was a result of lower variable costs associated with the decline in procedure volume along with other savings. These savings primarily included lower laser maintenance fees from managing purchases, lower financing fees from renegotiated rates and a shift in portfolio mix, reductions in employee-related costs and lower insurance costs from favorable claims experience.
  • Marketing expense decreased by $1.2 million to $5.4 million from $6.6 million, bringing marketing cost per eye to $413 from $460.
  • General and administrative expenses decreased by $0.5 million to $2.9 million from $3.4 million, due primarily to reductions in employee-related costs as a result of restructuring initiatives implemented early this year.
  • Depreciation expense decreased by $0.7 million to $0.5 million from $1.2 million, due to lower capital expenditures in recent years.
  • Operating income was $0.3 million, a $3.6 million improvement from an operating loss of $3.3 million; adjusted operating income was $0.1 million, a $4.0 million improvement from an adjusted operating loss of $3.9 million.
  • Net income was $0.5 million, or $0.02 per diluted share, a $3.7 million improvement from a net loss of $3.2 million, or $0.17 per share.

First Half 2013 Financial and Operating Highlights (all comparisons are with the first half of 2012)

  • Revenues were $50.9 million compared with $61.3 million; adjusted revenues were $50.3 million compared with $59.8 million.
  • Procedure volume was 29,266 compared with 35,402.
  • Medical professional and license fees decreased by $3.5 million to $11.0 million from $14.5 million. The decrease resulted from lower procedure volume coupled with the impact from the company’s purchase of its previously leased excimer lasers.
  • Vision center direct costs decreased by $3.9 million to $19.5 million from $23.4 million. The decrease was a result of lower variable costs associated with the procedure volume combined with other cost savings. These savings primarily included lower financing fees from renegotiated rates and a shift in portfolio mix, reductions in employee-related costs, lower insurance costs from favorable claims experience and lower laser maintenance fees from managing purchases.
  • Marketing expense decreased by $1.6 million to $11.9 million from $13.5 million. Marketing cost per eye was $408 compared with $381.
  • General and administrative expenses decreased by $1.0 million to $6.1 million from $7.1 million, due primarily to reductions in employee-related costs and rent from the relocation of the company’s call center as a result of restructuring initiatives implemented in early 2013.
  • Depreciation expense decreased by $1.5 million to $1.0 million from $2.5 million, due to lower capital expenditures in recent years.
  • Operating income was $1.3 million, a $0.9 million improvement from operating income of $0.4 million; adjusted operating income was $0.8 million, a $1.7 million improvement from an adjusted operating loss of $0.9 million.
  • Net income was $1.7 million, or $0.09 per diluted share, a $1.0 million improvement from net income of $0.7 million, or $0.03 per diluted share.
  • Cash and investments were $30.9 million as of June 30, 2013, compared with $34.5 million as of December 31, 2012. The cash use was due primarily to working capital changes from merchant receivables and prepaid license fee purchases in addition to restructuring payments related to severance and lease obligations for previously closed vision centers. The cash use also included start-up losses related to the company’s refractive lens and cataract business.
  • In April 2013, the company purchased for $2.3 million the previously leased excimer lasers used in all of its full-service vision centers. The purchase was financed by the vendor over a three-year term at an interest rate of 3.5%.

The company provides adjusted revenues and operating income (loss) as a means of measuring performance that adjusts for the non-cash impact of accounting for separately priced extended warranties.  A reconciliation of revenues and operating income (loss) as reported in accordance with U.S. Generally Accepted Accounting Principles (GAAP) is provided at the end of this news release.  Management believes that the adjusted information better reflects operating performance and, therefore, is more meaningful to investors.

“We reported positive net income for the quarter due to a combination of cost savings from restructuring initiatives implemented early this year, new cost savings and our purchase of excimer lasers that we previously leased, which lowered the per-use fee for procedures performed with this equipment,” said LCA-Vision Chief Executive Officer Michael J. Celebrezze.  “As a result, we are reducing our estimate of the annual number of procedures to reach cash-flow breakeven for our LASIK business by 2,000 to 56,000, moving us closer to our goal of sustained profitability for this business.

“Our conversion metrics remained strong across the board and we improved average revenue per procedure to $1,722, an increase of $23 year-over-year and $5 sequentially.  We also significantly reduced our year-over-year decline in procedure volume compared with this year’s first quarter, although we anticipate that procedure volume will be negatively impacted throughout 2013 due to the lowering of the maximum contribution to flexible spending accounts mandated by the federal government at the beginning of the year.  We are taking a more integrated, synergistic approach to our advertising, managed care and partner network programs to improve marketing, while continuing to work on optimizing media mix and refining messages.  Currently, we are offering several discount promotions to support patient acquisition.

“We are pleased with the initial success of our partner network of optometrists, which is nearly self-sustaining from a financial perspective with net revenues exceeding our overhead costs.  About 1.7% of our second quarter procedure volume resulted from co-management, up from approximately 1% in the first quarter.  Among the measures underway to fully establish this program, we are focused on improving vision center staff relationships with our partners and managing patient flow.  Our plan is to add more partners throughout the current year and beyond,” added Celebrezze.

Near-Term Financial Outlook
LCA-Vision intends to manage expenses conservatively in 2013; its plans and outlook for the year include:

  • The company plans to open one additional full-service licensed vision center in the second half of 2013, in addition to the two full-service licensed vision centers opened since the beginning of 2013. The company also intends to continue leveraging marketing spend by adding satellite vision centers in established LasikPlus® markets. The company has opened three satellite centers since the beginning of 2013, and plans to open at least one additional satellite center in the current year.
  • The company revised its expectations for annual capital expenditures to be between $0.8 million and $1.2 million, from its prior outlook of $3.1 million to $3.5 million. The previous guidance assumed that the $2.3 million purchase of excimer lasers would be recorded at gross, impacting both capital expenditures and borrowings. As no cash changed hands in this transaction, it was reported at net.
  • For the third quarter of 2013, the company expects marketing and advertising expenses to be between $4.8 million and $5.3 million.

As noted above, the company lowered its estimate for the annual number of procedures companywide necessary to reach cash-flow breakeven from its LASIK business to approximately 56,000, from the prior estimate of 58,000, after capital expenditures and debt service.  This cash-flow estimate does not include restructuring payments, or start-up losses and capital expenditures for its refractive lens and cataract business.  The company expects to continue to incur start-up losses and capital investment for its business expansion initiatives.

Conference Call and Webcast
As previously announced, a conference call and webcast will be held today beginning at 10:00 a.m. Eastern time. To access the conference call, dial 866-322-1352 (U.S. and Canada) or 706-643-6246 (international callers).  A webcast will be available in the investor relations section of LCA-Vision’s website. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (U.S. and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 10544407.

Forward-Looking Statements 
This news release contains forward-looking statements based on current expectations, forecasts and assumptions of LCA-Vision that are subject to risks and uncertainties.  The forward-looking statements in this release are based on information available to the company as of the date hereof.  Actual results could differ materially from those stated or implied in the forward-looking statements due to risks and uncertainties associated with its business.  In addition to the risk factors discussed in the company’s Form 10-K and other filings with the Securities and Exchange Commission, there are a number of other risks and uncertainties associated with its business including, without limitation, the successful execution of cost effective marketing strategies to drive patients to its vision centers; the impact of low consumer confidence and discretionary spending; competition in the laser vision correction industry; the possibility of adverse outcomes or long-term side effects of laser vision correction and negative publicity regarding laser vision correction; the company’s ability to operate profitable vision centers and retain qualified personnel during periods of lower procedure volumes; the company’s success in expanding its services into the cataract market; additional regulatory requirements, such as for Medicare, related to cataract; the continued availability of non-recourse third-party financing for its patients on terms similar to what it has paid historically; the company’s ability to achieve profitability in its developing business expansion initiatives and the future value of revenues financed by the company and its ability to collect on such financings, which will in turn depend on a number of factors, including the consumer credit environment and the company’s ability to manage credit risk related to consumer debt, bankruptcies and other credit trends.

Further, the Food and Drug Administration’s (FDA) advisory board on ophthalmic devices currently is reviewing concerns about post-LASIK quality of life matters, and the FDA is recruiting participants for two studies on LASIK outcomes and quality of life.  The FDA or another regulatory body could take legal action against the company or others in the laser vision correction industry. The outcome of this review or legal action potentially could impact negatively the acceptance of LASIK.  In addition, the acceptance rate of new technologies and our ability to implement successfully new technologies on a national basis create additional risk.

Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, the company assumes no obligation to update the information included in this news release, whether as a result of new information, future events or circumstances, or otherwise.

About LCA-Vision Inc./LasikPlus®
LCA-Vision Inc., a leading provider of laser vision correction services under the LasikPlus® brand, operates 58 LasikPlus® vision centers in the United States: 51 full-service LasikPlus® fixed-site laser vision correction centers and seven pre- and post-operative LasikPlus® satellite centers. Since 1991 more than 1.3 million laser vision correction procedures have been performed at the company’s vision centers.

Earning Trust Every Moment; Transforming Lives Every Day.

For Additional Information

Company Contact:                 Investor Relations Contact:
Barb Kise Jody Cain
LCA-Vision Inc. LHA
513-792-5629 310-691-7100 – jcain@lhai.com
@LHA_IR_PR

 

 

LCA-Vision Inc.
Condensed Consolidated Balance Sheets  (Unaudited)
(Dollars in thousands)
June 30, 2013 December 31, 2012
Assets
Current assets
   Cash and cash equivalents $         30,866 $             31,653
   Short-term investments 2,804
   Patient receivables, net of allowances of $951 and $1,019, respectively 3,195 2,810
   Other accounts receivable, net 1,627 443
   Prepaid expenses and other 3,864 3,318
Total current assets 39,552 41,028
Property and equipment, net 7,447 6,380
Patient receivables, net of allowances of $592 and $634, respectively 1,301 1,059
Other assets 223 501
Total assets $         48,523 $             48,968
Liabilities and Stockholders’ Investment
Current liabilities
   Accounts payable $           7,848 $               8,046
   Accrued liabilities and other 8,628 11,930
   Debt obligations maturing within one year 861
Total current liabilities 17,337 19,976
Other long-term liabilities 2,468 3,454
Long-term insurance reserves, less current portion 5,655 5,741
Long-term debt obligations, less current portion 1,404
Stockholders’ investment
   Common stock ($.001 par value; 25,291,637 shares issued and
     19,240,820 and 19,050,504 shares outstanding, respectively) 25 25
   Contributed capital 180,212 179,543
   Common stock in treasury, at cost (6,050,817 shares and 6,241,133 shares, respectively) (110,093) (111,395)
   Accumulated deficit (48,919) (49,053)
   Accumulated other comprehensive income 434 677
Total stockholders’ investment 21,659 19,797
Total liabilities and stockholders’ investment $         48,523 $             48,968

 

 

LCA-Vision Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited)
(Amounts in thousands except per share data)
Three months ended June 30, Six months ended June 30,
2013 2012 2013 2012
Revenues $       22,609 $       25,152 $       50,913 $       61,289
Operating costs and expenses
Medical professional and license fees 4,229 5,809 10,963 14,491
Direct costs of services 9,431 11,500 19,492 23,410
General and administrative expenses 2,906 3,407 6,055 7,113
Marketing and advertising 5,367 6,628 11,937 13,479
Depreciation 484 1,209 1,039 2,521
Restructuring and impairment charges 37 219 37
22,417 28,590 49,705 61,051
Gain on sale of assets 108 110 115 188
Operating income (loss) 300 (3,328) 1,323 426
Net investment income and other 235 162 451 278
Income (loss) before taxes on income 535 (3,166) 1,774 704
Income tax expense 72 24 107 48
Net income (loss) $            463 $       (3,190) $         1,667 $            656
Earnings (loss) per common share
   Basic $           0.02 $         (0.17) $           0.09 $           0.03
   Diluted $           0.02 $         (0.17) $           0.09 $           0.03
Weighted average shares outstanding
   Basic 19,117 18,991 19,152 18,943
   Diluted 19,195 18,991 19,301 19,129
Other comprehensive (loss) income, net of tax:
   Foreign currency translation adjustment $          (146) $          (125) $          (243) $            (22)
   Unrealized investment gain 43 30
Total other comprehensive (loss) income, net of tax $          (146) $            (82) $          (243) $                8
Comprehensive income (loss) $            317 $       (3,272) $         1,424 $            664

 

 

LCA-Vision Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(Dollars in thousands)
Six months ended June 30,
2013 2012
Cash flow from operating activities:
Net income $             1,667 $                656
Adjustments to reconcile net income to net cash (used in) provided by operating activities:
   Depreciation 1,039 2,521
   Provision for loss on doubtful accounts 276 518
   Loss on sale of investments 8
   Impairment charges 37
   Gain on sale of assets (115) (188)
   Stock-based compensation 669 1,082
   Insurance reserve (98) 100
   Changes in operating assets and liabilities:
     Patient accounts receivable (926) (1,624)
     Other accounts receivable (1,164) (135)
     Prepaid expenses and other (1,376) 520
     Accounts payable (198) (163)
     Deferred revenue, net of professional fees (542) (1,338)
     Accrued liabilities and other (2,291) (1,548)
Net cash (used in) provided by operations (3,059) 446
Cash flow from investing activities:
   Purchases of property and equipment (195) (589)
   Proceeds from sale of assets 137 207
   Purchases of investment securities (36,855)
   Proceeds from sale of investment securities 2,804 59,264
Net cash provided by investing activities 2,746 22,027
Cash flow from financing activities:
   Principal payments on loans (4,004)
   Shares repurchased for treasury stock (231) (357)
   Proceeds from exercise of stock options 57
Net cash used in financing activities (231) (4,304)
Net effect of exchange rate changes on cash and cash equivalents (243) (22)
(Decrease) increase in cash and cash equivalents (787) 18,147
Cash and cash equivalents at beginning of period 31,653 18,568
Cash and cash equivalents at end of period $           30,866 $           36,715

 

LCA-Vision Inc.
Effect of the Change in Accounting for Deferred Revenues on Financial Results
(Dollars in thousands)
(Unaudited)

To supplement its Consolidated Financial Statements presented in accordance with accounting principles generally accepted in the United States, LCA-Vision discusses adjusted revenues and operating income and loss. Management utilizes this information as a means of measuring performance that adjusts for the non-cash impact of the accounting for separately priced extended warranties and believes that including this additional disclosure is meaningful to investors for the same reason.

Accordingly, this news release contains non-GAAP financial measures within the meaning of Regulation G promulgated by the Securities and Exchange Commission. A reconciliation of the difference between the non-GAAP measures with the most directly comparable financial measures calculated in accordance with GAAP follows:

Three Months Ended June 30, Six Months Ended June 30,
2013 2012 2013 2012
Revenues
     Reported U.S. GAAP $        22,609 $        25,152 $        50,913 $        61,289
     Adjustments
        Amortization of prior deferred revenue (233) (666) (602) (1,487)
     Adjusted revenues $        22,376 $        24,486 $        50,311 $        59,802
Operating income (loss)
     Reported U.S. GAAP $             300 $         (3,328) $          1,323 $             426
     Adjustments
        Amortization of prior deferred revenue (233) (666) (602) (1,487)
        Amortization of prior professional fees 23 67 60 149
     Adjusted operating income (loss) $               90 $         (3,927) $             781 $            (912)
Tuesday, July 30th, 2013 Uncategorized Comments Off on (LCAV) Second Quarter Financial Results Feature EPS of $0.02

(SPEX) Announces its First Settlement and License Agreement

NEW YORK, July 30, 2013 /PRNewswire/ — North South Holdings Inc. (“North South”) — an intellectual property development company, today reported that its wholly owned subsidiary, CompuFill LLC, has entered into a settlement and license agreement with a leading technology company.

This is the first settlement and license agreement for the CompuFill portfolio since North South’s acquisition of CompuFill in April 2013 and commencement of its licensing campaign.  Ongoing infringement continues, and the CompuFill portfolio is currently being enforced against additional defendants.   

The CompuFill patents, each in the “on-line pharmacy automated refill system” sector, trace priority back to October 1997.

Commenting on the announcement, Anthony Hayes, North South CEO, stated, “The value of having this suite of patents cannot be emphasized enough. Our team of patent monetization experts brought this opportunity to North South only a few short months ago and we have already started generating revenue. This is a great example of how North South is working to drive value for our investors.”

About North South Holdings Inc.
North South Holdings Inc. was formed on November 9, 2012 to seek business opportunities in which to acquire patents from various entities and monetize those patents through sales, litigation or licensing.  North South recently entered into an agreement to be acquired by Spherix Incorporated (NASDAQ: SPEX).

About Spherix Incorporated
Spherix Incorporated (NASDAQ: SPEX) was launched in 1967 as a scientific research company. Spherix presently offers a diversified commercialization platform for protected technologies. The company continues to work on life sciences and drug development and presently is exploring opportunities in nutritional supplement products relying on its D-Tagatose natural sweetener as a GRAS ingredient. Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation. Through its recently announced acquisition of several hundred patents issued to Harris Corporation Spherix intends to expand its activities in wireless communications and telecommunication sectors including antenna technology, Wi-Fi, base station functionality, and cellular.

Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While North South believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties. Thus, actual results could be materially different. North South expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact Information:
Anthony Hayes, CEO
North South Holdings Inc.
110 Greene Street; Suite 403
New York, NY 10012
347-855-6146
anthony@northsouthholdings.com
www.northsouthholdings.com

Tuesday, July 30th, 2013 Uncategorized Comments Off on (SPEX) Announces its First Settlement and License Agreement

(GALE) to Present at the 8th Annual JMP Securities Healthcare Conference

LAKE OSWEGO, Ore., July 2, 2013 (GLOBE NEWSWIRE) — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President & CEO, will present a corporate update at the 8th Annual JMP Securities Healthcare Conference. The presentation will take place on Wednesday, July 10, 2013 at 10:30 a.m. ET at The St. Regis Hotel in New York, NY.

The presentation will be webcast and available on the Investors section of the Company’s website at www.galenabiopharma.com.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at www.galenabiopharma.com.

CONTACT: Remy Bernarda
         Senior Director, Communications
         (503) 405-8258
         rbernarda@galenabiopharma.com

Galena Biopharma, Inc.


				
								
								
				
Tuesday, July 30th, 2013 Uncategorized Comments Off on (GALE) to Present at the 8th Annual JMP Securities Healthcare Conference

(DOVR) Announces Earnings Release Date and Q2 Webcast

LITTLETON, MA–(Marketwired – Jul 29, 2013) – Dover Saddlery, Inc. (NASDAQ: DOVR) will release its second quarter 2013 results after the market closes on Thursday, August 8th, 2013.

Dover Saddlery executives will host a conference call to review results at 4:15pm ET on the same day. Interested parties may access the call by dialing +1-877-712-7037 or may listen to the call live via webcast. To access the webcast please go to http://investor.shareholder.com/DOVR/events.cfm and click on the webcast icon.

About Dover Saddlery, Inc.
Dover Saddlery, Inc. (NASDAQ: DOVR) is the leading multichannel retailer of equestrian products in the United States. Founded in 1975 in Wellesley, Massachusetts, by United States Equestrian team members, Dover Saddlery has grown to become The Source® for equestrian products. Dover offers a broad and distinctive selection of competitively priced, brand-name products for horse and rider through catalogs, the Internet and company-owned retail stores. Dover Saddlery, Inc. serves the English rider and through Smith Brothers, the Western rider. The Source®, Dover Saddlery® and Smith Brothers® are registered marks of Dover Saddlery.

For more information, please call 1-978-952-8062 or visit www.DoverSaddlery.com.

 

Janet Nittmann

Tel 978-952-8062 x218

Email Contact

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(MWIV) Announces 2013 Third Quarter Results and Business Outlook Updates

BOISE, ID–(Marketwired – Jul 29, 2013) – MWI Veterinary Supply, Inc. (NASDAQ: MWIV) (the “Company”) announced financial results today for its third quarter ended June 30, 2013.

Highlights:

  • Total revenues were $606.4 million for the quarter, 9.3% higher than revenues for the same period in the prior fiscal year. Revenue growth was 11.3% in the United States.
  • Gross profit as a percentage of total revenues improved to 12.8% for the quarter, compared to 12.5% for the same period in the prior fiscal year.
  • Operating income was $26.5 million for the quarter, 13.9% higher than operating income for the same period in the prior fiscal year. Operating income as a percentage of total revenues improved to 4.4% for the quarter, compared to 4.2% for the same period in the prior fiscal year.
  • Net income was $16.8 million for the quarter, 15.7% higher than net income for the same period in the prior fiscal year. Diluted earnings per share were $1.32 for the quarter, compared to $1.15 for the same period in the prior fiscal year.
  • We generated cash flow from operations for the nine months ended June 30, 2013 of $60.5 million compared to cash provided by operations of $5.4 million for the same period in the prior fiscal year.
  • Internet sales to independent veterinary practices and producers in the United States grew by 25.8% for the quarter compared to the same period in the prior fiscal year.
  • Revenues from our veterinary pharmacy programs in the United States increased 11.6% to $51.3 million for the quarter compared to the same period in the prior fiscal year.
  • The rollout of our Diagnostics Unlimited program continued to perform very well as revenues to all customers reached approximately $43 million for the quarter.

“Our results for the quarter continued to be strong,” said Jim Cleary, President and Chief Executive Officer. “Our revenue growth in the United States was double-digit. Both our gross margin and cash flow exceeded our expectations. We experienced very positive results from our value-added services, and our diagnostics rollout continued to generate great results and customer service.”

Quarter ended June 30, 2013 compared to quarter ended June 30, 2012

Total revenues increased 9.3% to $606.4 million for the quarter ended June 30, 2013, compared to $554.7 million for the quarter ended June 30, 2012. Revenue growth in the United States was 11.3% for the quarter ended June 30, 2013, compared to the quarter ended June 30, 2012. Organic revenues were flat in the United Kingdom but decreased by 3.0% related to foreign currency translation. Commissions increased 4.8% to $4.8 million for the quarter ended June 30, 2013, compared to $4.6 million for the quarter ended June 30, 2012.

Gross profit increased by 11.5% to $77.5 million for the quarter ended June 30, 2013, compared to $69.5 million for the quarter ended June 30, 2012. Gross profit as a percentage of total revenues improved to 12.8% for the quarter ended June 30, 2013, compared to 12.5% for the quarter ended June 30, 2012 due to an improvement in vendor rebates as a percentage of total revenues. Vendor rebates for the quarter ended June 30, 2013 increased by approximately $3.0 million compared to the quarter ended June 30, 2012 primarily due to the timing of manufacturer rebate programs and growth in revenues.

Operating income increased 13.9% to $26.5 million for the quarter ended June 30, 2013, compared to $23.3 million for the quarter ended June 30, 2012. SG&A expenses increased 10.2% to $48.4 million for the quarter ended June 30, 2013, compared to $44.0 million for the quarter ended June 30, 2012. SG&A expenses as a percentage of total revenues were 8.0% for the quarter ended June 30, 2013, compared to 7.9% for the quarter ended June 30, 2012. The increase in SG&A expenses was primarily due to an increase in compensation and benefit costs.

Net income increased 15.7% to $16.8 million for the quarter ended June 30, 2013, compared to $14.5 million for the quarter ended June 30, 2012. Diluted earnings per share were $1.32 and $1.15 for the quarter ended June 30, 2013 and 2012, respectively, an increase of 14.8%.

As of June 30, 2013, we had $11.8 million outstanding on our credit facilities after acquiring substantially all of the assets of PCI Animal Health for approximately $17 million on December 31, 2012, compared to $48.1 million as of September 30, 2012.

Nine months ended June 30, 2013 compared to nine months ended June 30, 2012

Total revenues increased 14.4% to $1.742 billion for the nine months ended June 30, 2013, compared to $1.524 billion for the nine months ended June 30, 2012. Excluding the revenues resulting from the acquisition of the assets of Micro during the month of October 2012, revenue growth in the United States was 12.7% for the nine months ended June 30, 2013, compared to the nine months ended June 30, 2012. We acquired the assets of Micro on October 31, 2011, and therefore did not own Micro for one month of the comparable nine month period in the prior fiscal year. Revenues resulting from the acquisition of Micro were $28.7 million during the month of October 2012. Revenue growth in the United Kingdom was 11.0% for the nine months ended June 30, 2013, consisting of 11.6% organic growth reduced by 0.6% related to foreign currency translation. Commissions increased 12.1% to $14.2 million for the nine months ended June 30, 2013, compared to $12.7 million for the nine months ended June 30, 2012.

Gross profit increased by 15.3% to $229.1 million for the nine months ended June 30, 2013, compared to $198.7 million for the nine months ended June 30, 2012. Gross profit as a percentage of total revenues improved to 13.1% for the nine months ended June 30, 2013, compared to 13.0% for the nine months ended June 30, 2012 due to an improvement in vendor rebates as a percentage of total revenues, offset in part by a decrease in product margin. Vendor rebates for the nine months ended June 30, 2013 increased by approximately $6.9 million compared to the nine months ended June 30, 2012 primarily due to the timing of manufacturer rebate programs and growth in revenues.

Operating income increased 17.8% to $77.8 million for the nine months ended June 30, 2013, compared to $66.1 million for the nine months ended June 30, 2012. SG&A expenses increased 14.3% to $143.8 million for the nine months ended June 30, 2013, compared to $125.8 million for the nine months ended June 30, 2012. SG&A expenses as a percentage of total revenues were 8.3% for each of the nine months ended June 30, 2013 and 2012. The increase in SG&A expenses was primarily due to an increase in compensation and benefit costs and Micro expenses for the month of October 2012.

Net income increased 19.0% to $48.6 million for the nine months ended June 30, 2013, compared to $40.9 million for the nine months ended June 30, 2012. Diluted earnings per share were $3.83 and $3.23 for the nine months ended June 30, 2013 and 2012, respectively, an increase of 18.6%.

Business Outlook

The Company estimates that for the fiscal year ending September 30, 2013, revenues will be from $2.330 billion to $2.360 billion, which represents growth of 12.3% to 13.7% compared to revenues in fiscal year 2012. The Company estimates that diluted earnings per share will be from $4.89 to $4.94 per share, which represents growth of 15.6% to 16.8% compared to diluted earnings per share in fiscal year 2012. The Company’s previous guidance for the fiscal year ending September 30, 2013 was revenues from $2.320 billion to $2.360 billion and diluted earnings per share of $4.79 to $4.89. These estimates are based on the Company’s current calendar-year and quarterly vendor contracts which typically undergo annual renegotiation and which may include terms such as rebates, commissions and exclusivity requirements.

Conference Call

The Company will be hosting a conference call on July 29, 2013 at 10:00 a.m. Eastern time to discuss in greater detail these results and its fiscal year 2013 business outlook. Participants can access the conference call by dialing (877) 638-4561 and international callers can access the conference call by dialing (720) 545-0002. The conference call will also be carried live on the Company’s web site at www.mwivet.com. Audio replay will be made available through August 5, 2013 by calling (855) 859-2056 for calls within the United States or (404) 537-3406 for international calls using the passcode 19215654. The conference call will also be available on the Company’s web site, www.mwivet.com.

MWI is a leading distributor of animal health products across the United States of America and United Kingdom. MWI sells both companion animal and production animal products including pharmaceuticals, vaccines, parasiticides, diagnostics, micro feed ingredients, supplies, pet food, capital equipment and nutritional products. MWI also is a leading innovator and provider of value-added services and technologies used by veterinarians and producers. For more information about MWI, please visit our website at www.mwivet.com. For investor relations information please contact Mary Pat Thompson, Senior Vice President of Finance and Administration, and Chief Financial Officer at (208) 955-8930 or email investorrelations@mwivet.com.

Certain statements contained herein that are not descriptions of historical facts are “forward-looking” statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those discussed in filings made by the Company with the Securities and Exchange Commission. Many of the factors that will determine the Company’s future results are beyond the ability of management to control or predict. Readers should not place undue reliance on forward-looking statements, which reflect management’s views only as of the date hereof. The Company undertakes no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Important assumptions and other important factors that could cause actual results to differ materially from those set forth in the forward-looking information include the impact of vendor consolidation on our business; changes in or availability of vendor contracts or rebate programs; exclusivity requirements with certain vendors that may prohibit us from distributing competing products manufactured by other vendors or margin reductions if we become a non-exclusive distributor; transitional challenges associated with acquisitions, including the failure to achieve anticipated synergies; vendor rebates based upon attaining certain growth goals; changes in the way vendors introduce/deliver products to market; a disruption caused by adverse weather (i.e. drought) or other natural conditions or disasters; possible changes in the use of feed additives (antibiotics, growth promotants) used in the production animal markets due to trade restrictions, consumer concern and/or government regulations; seasonality; unforeseen litigation; risks associated with our international operations; financial risks associated with acquisitions and investments; the impact of general economic trends on our business; the recall of a significant product by one of our vendors; extended shortage or backorder of a significant product by one of our vendors; the timing and effectiveness of marketing programs or price changes offered by our vendors; the timing of the introduction of new products and services by our vendors; our intellectual property rights may be inadequate to protect our business; the ability to borrow on our credit line, extend the terms of our credit line or obtain alternative financing on favorable terms or at all; risks from potential increases in variable interest rates; the impact of tightening credit standards and/or access to credit on behalf of our customers and suppliers; inability to ship products to the customer as a result of technological or shipping disruptions; and competition. Other factors include changes in the rate of inflation; changes in state or federal legislation or regulation; the continued safety of the products the Company sells; and changes in the general economy. Investors should also be aware that while we do, from time to time, communicate with securities analysts, it is against our policy to disclose any material non-public information or other confidential commercial information. Accordingly, stockholders should not assume that we agree with any statement or report issued by any analyst irrespective of the content of the statement or report. Furthermore, we have a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of MWI Veterinary Supply, Inc.

MWI Veterinary Supply, Inc.
(Unaudited – Dollars and shares in thousands, except per share amounts)
Condensed Consolidated Quarter Ended June 30, Nine Months Ended June 30,
Statements of Income 2013 2012 2013 2012
Revenues $ 606,443 $ 554,669 $ 1,742,405 $ 1,523,740
Cost of product sales 528,932 485,150 1,513,286 1,325,089
Gross profit 77,511 69,519 229,119 198,651
Selling, general and administrative expenses 48,432 43,959 143,820 125,799
Depreciation and amortization 2,545 2,273 7,450 6,739
Operating income 26,534 23,287 77,849 66,113
Interest expense (173 ) (249 ) (599 ) (684 )
Other income 229 241 820 771
Income before taxes 26,590 23,279 78,070 66,200
Income tax expense (9,809 ) (8,776 ) (29,438 ) (25,323 )
Net income $ 16,781 $ 14,503 $ 48,632 $ 40,877
Net income per share – diluted $ 1.32 $ 1.15 $ 3.83 $ 3.23
Weighted average common
shares outstanding – diluted 12,713 12,662 12,705 12,638
Condensed Consolidated Balance Sheets June 30,
2013
September 30,
2012
Assets
Cash $ 531 $ 514
Receivables, net 310,303 288,922
Inventories 283,589 251,375
Prepaid expenses and other current assets 6,006 10,094
Deferred income taxes 2,853 1,580
Total current assets 603,282 552,485
Property and equipment, net 37,772 35,784
Goodwill 70,588 61,841
Intangibles, net 40,428 38,706
Other assets, net 8,119 7,567
Total Assets $ 760,189 $ 696,383
Liabilities
Credit facilities $ 11,781 $ 48,080
Accounts payable 308,987 258,741
Accrued expenses and other current liabilities 20,070 19,952
Current portion of capital lease obligations 127 337
Total current liabilities 340,965 327,110
Deferred income taxes 8,690 7,180
Long-term debt and capital lease obligations 33 104
Other long-term liabilities 2,290 2,687
Stockholders’ Equity 408,211 359,302
Total Liabilities and Stockholders’ Equity $ 760,189 $ 696,383

Contact:
Mary Pat Thompson
Senior Vice President of Finance and Administration and Chief Financial Officer
(208) 955-8930

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(NSPR) Announces First Patient Enrolled in U.S. Registration Trial for MGuard™ Prime EPS

BOSTON and TEL AVIV, Israel, July 29, 2013 /PRNewswire/ — InspireMD, Inc. (NYSE MKT: NSPR) (“Inspire” or the “Company”), a leader in embolic protection stents, said the first patient has been enrolled in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard™ Prime Embolic Protection Stent (EPS) in patients suffering from ST Elevation Myocardial Infarction (STEMI).

The multi-center, randomized trial is expected to include up to 70 sites in the U.S. and Europe and as many as 1,114 patients. The results are intended to support the Company’s Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) to market the MGuard™ Prime MicroNet™ covered coronary stent system in the U.S.

The trial has two co-primary endpoints: superiority in complete ST resolution and non-inferiority in death and target vessel myocardial infarction. In addition, a 356 patient sub-study will be conducted to assess the effect of the MGuard Prime™ EPS on infarct size, as measured by Magnetic Resonance Imaging (MRI).

The trial’s principal investigators are Gregg Stone, M.D. of New York Presbyterian Hospital and Columbia University Medical Center in New York City, and Jose P. S. Henriques, M.D. of the Academic Medical Center in Amsterdam.

The first procedure was performed at ZNA Middelheim by Stefan Verheye, M.D. “Distal embolization and no-reflow are severe concerns when treating our STEMI patients. From our experience over the last two years, the MGuard Prime EPS has improved patient outcome and led to brilliant results, thanks to its unique protective mesh,” said Dr. Verheye. “I am excited about participating in the MASTER II Trial and enthusiastic about its potential impact on patient care worldwide.”

“Enrolling our first patient in MASTER II is a very important milestone for the company. We are committed to advancing patient care through robust clinical research,” said Alan Milinazzo, InspireMD’s CEO and President. “MASTER II provides another important opportunity for us to demonstrate the safety of MGuard EPS and to validate its effectiveness compared to current standard of care treatment for STEMI patients.”

The FDA trial, known as MASTER II (MGuard™ for Acute ST Elevation Reperfusion), is the second in a series of randomized clinical studies intended to validate the safety and effectiveness of the MGuard™ EPS platform and achieve registration with appropriate regulatory authorities worldwide.

InspireMD’s MGuard™ EPS technology previously yielded positive results in the MASTER Trial findings, showing a statistically and clinically significant acute advantage with regard to ST segment resolution. As a result, the MGuard™ EPS may hold the potential to lower the incidence of adverse events and improve the survival of patients suffering from acute myocardial infarction.

About Stenting and MGuard™ EPS

Standard stents were not engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.

The MGuard™ EPS is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.

While offering superior performance relative to standard stents in STEMI patients with regard to ST segment resolution, the MGuard™ EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard technology to make its products the industry standard for embolic protection stents and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

MGuard™ EPS is CE Mark approved. It is not approved for sale in the U.S. by the FDA at this time.

Forward-looking Statements:

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multi-national companies, (v) product liability claims, (vi) our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (viii) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Transition Report on Form 10-K/T and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

For additional information:
InspireMD Desk
Redington, Inc.
+1-212-926-1733
+1-203-222-7399
inspiremd@redingtoninc.com

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(PRAN) Doses First Patient in PBT2 Alzheimer’s Extension Study

MELBOURNE, AUSTRALIA–(Marketwired – Jul 29, 2013) – Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that the first patient has been dosed in the 12-month open-label extension study with Alzheimer’s Disease patients participating in Prana’s Phase 2 IMAGINE trial.

Patients who have completed the full 12-month term of the IMAGINE trial are eligible for participation in the open-label Extension study. All participants in the Extension study will receive a 250mg once daily oral dose of PBT2 for an additional 12 months.

The IMAGINE trial is a 12-month double-blind Phase 2 clinical trial of PBT2 in mild or prodromal Alzheimer’s patients. The Extension study does not alter the completion and reporting on the IMAGINE trial with results expected in March 2014.

Prana’s Chairman and CEO, Geoffrey Kempler, said: “We anticipate a high level of patient interest in participating in this Extension study given the support expressed from the physicians involved.”

About Prana Biotechnology Limited
Prana Biotechnology was established to commercialise research into age-related neurodegenerative disorders. The Company was incorporated in 1997 and listed on the Australian Securities Exchange in March 2000 and listed on NASDAQ in September 2002. Researchers at prominent international institutions including The University of Melbourne, The Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.

For further information please visit the Company’s web site at www.pranabio.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “may,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, PBT2, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, PBT2, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, PBT2, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to PBT2, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

Contacts:
PranaBiotechnology Limited
+61 3 9349 4906

USA:
Vivian Chen and Christopher Chu
Grayling
T: +1 646-284-9472, +1 646-284-9426
E: Vivian.Chen@grayling.com, Christopher.chu@grayling.com

Media:
Ivette Almeida
T: 646-284-9455
E:
Ivette.almeida@grayling.com

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(URRE) Announces Second Quarter Conference Call and Webcast

LEWISVILLE, Texas, July 29, 2013 (GLOBE NEWSWIRE) — Uranium Resources, Inc. (Nasdaq:URRE) (“URI”) will host a conference call and webcast on Friday, August 9, 2013 at 11:30 a.m. ET. During the call, Christopher M. Jones, President and CEO, and Jeffrey L. Vigil, Vice President and Chief Financial Officer, will provide an update on URI’s strategies, outlook, and progress in advancing its Texas and New Mexico properties. A question-and-answer session will follow.

The URI conference call can be accessed by calling (201) 689-8471. The live webcast can be monitored at www.uraniumresources.com.

A telephonic replay will be available from 2:30 p.m. ET the day of the teleconference until Friday, August 16, 2013. To listen to the archived call, dial (858) 384-5517 and enter replay pin number 417986. Alternatively, the webcast replay can be heard on the Company’s website and a transcript will also be posted, once available.

About Uranium Resources, Inc.

Uranium Resources, Inc. explores for, develops and mines uranium. Since its incorporation in 1977, URI has produced uranium by in-situ recovery (ISR) methods in the state of Texas and currently has a number of initiatives underway to return the Company to production. URI has over 206,600 acres of uranium mineral holdings and 144.8 million pounds of in-place mineralized uranium material in New Mexico and an NRC license to produce up to 3 million pounds of uranium per year. URI has an additional 664,000 pounds of in-place reserves in Texas. The Company acquired these properties over the past 20 years along with an extensive information database of historic drill hole logs, assay certificates, maps and technical reports.

Uranium Resources routinely posts news and other information about the Company on its website at www.uraniumresources.com.

CONTACT: Investor Contact:
         Deborah K. Pawlowski
         Kei Advisors LLC
         Phone: 716.843.3908
         Email: dpawlowski@keiadvisors.com
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(SPEX) Closes Rockstar Patent Acquisition Transaction

Spherix Closes Rockstar Patent Acquisition Transaction and Enhances Its Patent Portfolio in Wireless Communications and Telecommunication Sectors — Rockstar Acquires Equity Stake in Spherix-Venture to Be Headed by Seasoned Monetization Executive

TYSONS CORNER, VA–(Marketwired – Jul 29, 2013) – Spherix Incorporated (NASDAQ: SPEX) an intellectual property development and life sciences company, today announced that it has closed the previously announced agreement to acquire a group of seven patents in the mobile communication sector, from Rockstar Consortium, the owner of over 4,000 patents formerly owned by Nortel Networks.

Under the terms of the agreement, Spherix acquired four families of mobile communication patents in exchange for initial consideration of up-front cash and $1,000,000 in Spherix common stock issued at $5.65 per share. Rockstar will also receive a percentage of future profits after recovery of patent monetization costs and an initial priority return on investment to Spherix. The shares are subject to a lockup agreement restricting future sales, subject to the satisfaction of certain price and volume targets.

Spherix Interim CEO Harvey Kesner stated, “We believe that we have entered a new phase of our development and are pleased to announce successful completion of our recent patent and monetization partnership with Rockstar. We have been working with our colleagues at Rockstar to identify opportunities for collaboration between us and this resulted in the selection of this suite of seven patents that cover mobile communication devices. We selected a suite of patents with well documented and easily understandable technology so that we can quickly proceed to seek agreements to support commercialization efforts and enforcement, if required. This acquisition, coupled with our recently announced acquisition of several hundred patents issued to Harris Corporation, allows us to expand our activities in the wireless communications and telecommunication sectors including antenna technology, Wi-Fi, base station functionality, and cellular. Our incoming CEO Anthony Hayes was instrumental in negotiating these contracts and securing appropriate patents for enforcement. As has been widely reported, Anthony is a seasoned monetization executive with numerous ‘wins’ under his belt, who will oversee our licensing and enforcement efforts and has broad access to patent owners and inventors.”

About Rockstar

Rockstar Consortium was launched in 2011 as an intellectual property (IP) licensing company. Based on Nortel Networks’ groundbreaking innovation engine, Rockstar manages a highly valued patent portfolio relevant to virtually all telecom and high tech services and devices. Rockstar is deeply committed to advancing innovation worldwide through its patent licensing program. To learn more about Rockstar please visit www.ip-rockstar.com.

About Spherix

Spherix Incorporated was launched in 1967 as a scientific research company. Spherix presently offers a diversified commercialization platform for protected technologies. The company continues to work on life sciences and drug development and presently is exploring opportunities in nutritional supplement products relying on its D-Tagatose natural sweetener as a GRAS ingredient. Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation. Through its recently announced acquisition of several hundred patents issued to Harris Corporation Spherix intends to expand its activities in wireless communications and telecommunication sectors including antenna technology, Wi-Fi, base station functionality, and cellular.

Forward Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:
Investor Relations
Phone: (703) 992-9325

Monday, July 29th, 2013 Uncategorized Comments Off on (SPEX) Closes Rockstar Patent Acquisition Transaction

(BKR) Enters into Agreement to Be Acquired by Integrated Mission Solutions

Michael Baker Corporation (“Baker”) (NYSE MKT:BKR) announced today that it has entered into a definitive merger agreement to be acquired by Integrated Mission Solutions, LLC (“IMS”), an affiliate of DC Capital Partners, LLC (“DC Capital”).

Under the terms of the agreement, which has been unanimously approved by Baker’s Board of Directors, Baker shareholders will receive $40.50 in cash for each share of common stock that they own, in a transaction valued at $396.9 million. The per share price represents a 37% premium to Baker’s closing share price of $29.60 on July 26, 2013, a 55% premium to the average 90-day share price, and a 93% premium to the share price on December 18, 2012, the day before DC Capital publicly proposed to acquire Baker.

Under the terms of the agreement, a subsidiary of IMS will commence a tender offer to acquire all of the outstanding Baker common shares. Baker’s Board of Directors unanimously approved the offer. Any shares not tendered in the offer will be acquired in a merger at the same cash price as paid in the tender offer. Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is expected to close late in the third quarter or early in the fourth quarter of 2013.

“Baker is a well-known and highly regarded firm in the architecture, engineering and construction services industry. The transaction, which we believe delivers outstanding value to shareholders, results from a thorough, extensive strategic assessment process initiated by the Board early this year,” said Baker’s Robert N. Bontempo, Chairman of the Board of Directors. “We believe that this union with IMS will provide substantial value to shareholders, while reinforcing our commitment to our customers to continuously provide them with excellent service and high quality professional services.”

In an effort to preserve Baker’s heritage and culture, IMS has agreed to retain the Baker name, maintain Baker’s presence in the Pittsburgh area, and keep the current organization and staff of Baker essentially intact.

Thomas J. Campbell, Chairman of IMS and Founder of DC Capital, said, “This is a significant step for both companies. The combination of Michael Baker and IMS will create a company with over $1.0 billion in revenue, approximately 5,000 employees, and a platform with global reach. IMS has a strong presence internationally with a history of operating on all five continents. This geographic footprint in support of our customers in growth areas such as infrastructure, development, intelligence, and technology combined with Michael Baker’s complementary capabilities, highly certified, security cleared workforce, and distinctive North American presence will greatly enhance our collective ability to manage and execute larger projects.”

Mr. Campbell also stated, “Michael Baker and IMS share a common employee and community-oriented culture. We both believe that our people are our most important asset and we share a commitment to investing in their professional development. Similarly, we believe our collective mission is to help our customers achieve their goals and objectives. Michael Baker has a depth of talent in all ranks within the organization. Michael Baker has a talented management team and we have been impressed by the interim leadership provided by H. James McKnight, Chief Legal Counsel, and Michael J. Zugay, Chief Financial Officer, who together form the Office of the Chief Executive. Our goal is to ensure a continuity of Michael Baker’s over 70 year legacy and culture. As such, the Michael Baker name and brand will remain, three members of the Michael Baker Board of Directors will join the combined company Board, and the headquarters for Michael Baker will remain in Moon Township, Pennsylvania. As a Pennsylvania company we have been impressed by Michael Baker’s commitment to supporting the Pennsylvania community and we support the protection of this tradition.”

The transaction will be financed through a combination of cash provided by IMS as well as debt financing that has been committed, subject to the terms of a commitment letter, by Jefferies Finance LLC. Jefferies LLC is also serving as exclusive financial advisor to IMS and DC Capital. Arnold & Porter LLP is serving as legal advisor to IMS and DC Capital.

Houlihan Lokey is serving as financial advisors to Baker in this transaction. Jones Day and K&L Gates are serving as legal advisors to Baker.

About Baker

Michael Baker Corporation (www.mbakercorp.com) provides engineering, design, planning and construction services for its clients’ most complex challenges worldwide. The firm’s primary business areas are architecture, aviation, defense, environmental, geospatial, homeland security, municipal & civil, oil & gas, rail & transit, telecommunications & utilities, transportation, urban development and water. With more than 3,000 employees in over 100 offices across the United States, Baker is focused on creating value by delivering innovative and sustainable solutions for infrastructure and the environment. Learn more at www.mbakercorp.com.

About Integrated Mission Solutions, LLC

Integrated Mission Solutions, LLC (“IMS”) is a rapidly growing, global provider of a comprehensive continuum of mission critical services and solutions including, but not limited to: Engineering and Construction, Technical and Professional Services, Full Life Cycle Support, Strategic Consulting and Competitive Intelligence, Intelligence Operational Support and Training, Intelligence Community Information Technology Solutions, Research, Test, Evaluation, Procurement, and Software Development, and Enterprise and Communications Solutions. IMS has a diverse customer base with a primary focus on the United States Intelligence Community, Department of State, Department of Defense, Department of Homeland Security, United States Army Corps of Engineers, and other federal agencies. Learn more at www.integratedmissionsolutionsllc.com.

About DC Capital Partners, LLC

DC Capital Partners, LLC is a private investment firm headquartered in Washington, DC focused on making control investments in middle market companies that provide differentiated and innovative services and solutions to the United States government. DC Capital’s investment strategy emphasizes sectors that it believes offer the most compelling growth opportunities including, but not limited to, Intelligence, Information Technology, Development, Security, Infrastructure, Construction, and Environmental services. Learn more at www.dccapitalpartners.com.

Important Information About the Tender Offer

This news release is not an offer to purchase or a solicitation of an offer to sell securities of Baker. The planned tender offer by Integrated Mission Solutions for all of the outstanding shares of common stock of Baker has not been commenced. On commencement of the tender offer, Integrated Mission Solutions will mail to Baker’s shareholders an offer to purchase and related materials and Baker will mail to its shareholders a recommendation statement with respect to the tender offer. Integrated Mission Solutions will file its offer to purchase with the Securities and Exchange Commission (“SEC”) on Schedule TO, and Baker will file its recommendation statement with the SEC on Schedule 14D-9. Baker shareholders are urged to read these materials carefully when they become available, since they will contain important information, including the terms and conditions of the offer. Baker shareholders may obtain a free copy of these materials (when they become available) and other documents filed by Integrated Mission Solutions or Baker with the SEC at the website maintained by the SEC at www.sec.gov. These materials also may be obtained (when they become available) for free by contacting the information agent in the tender offer (when one is selected).

Note with respect to Forward-Looking Statements:

(This press release contains forward-looking statements with respect to the tender offer and related transactions, including the benefits expected from the acquisition and the expected timing of the completion of the transaction. When used in this press release, the words “can,” “will,” “intends,” “expects,” “is expected,” similar expressions and any other statements that are not historical facts are intended to identify those assertions as forward-looking statements. Such statements are based on a number of assumptions that could ultimately prove inaccurate, and are subject to a number of risk factors, including uncertainties regarding the timing of the closing of the transaction and the risk that the transaction will not close. Factors that could cause actual results to differ materially include the following: the risk that a majority of Baker shares do not tender their stock in the tender offer, the risk that the company experiences a material adverse change giving IMS the right not to close the transaction, the risk that IMS is unable to close on its financing and the risk that Baker’s businesses will suffer due to uncertainty related to the transaction, the competitive environment in our industry and competitive responses to the transaction. Baker does not assume any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Further information on factors that could affect Baker’s financial results is provided in documents filed by Baker with the SEC, including Baker’s recent filings on Form 10-Q and Form 10-K.)

Monday, July 29th, 2013 Uncategorized Comments Off on (BKR) Enters into Agreement to Be Acquired by Integrated Mission Solutions

(SNTA) Announces ENCHANT-1 Breast Cancer Results

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced today that preliminary results from the ENCHANT-1 clinical trial, which evaluates ganetespib monotherapy in patients with newly diagnosed locally advanced or metastatic HER2 positive or triple-negative breast cancer (TNBC), achieved the prespecified criteria for advancing to the second stage of the trial.

Of the initial five HER2-positive patients enrolled in the study, two achieved objective tumor response and two achieved stable disease (SD) within the three cycles of treatment on study (12 weeks). Of the initial ten TNBC patients enrolled and evaluable for response, two achieved objective tumor response and three achieved SD following treatment with ganetespib monotherapy.

ENCHANT-1 is a ‘window-of-opportunity’ study designed to evaluate the clinical activity of single-agent ganetespib over a 12-week period preceding standard first line treatment. The protocol specifies advancing to the second stage of enrollment in each cohort if there was at least one objective tumor response out of the initial fifteen evaluable patients specified for Stage 1. This criterion was achieved in both cohorts, and therefore both cohorts will continue to enroll patients up to a total of 33 evaluable patients per cohort.

Metabolic response was also assessed in the study, by comparing baseline and week 3 PET scans. Of the five HER2-positive patients, four achieved metabolic responses. Of the 13 TNBC patients with post-baseline PET scans, six achieved metabolic response.

“Ganetespib appears to be what many of us in the Hsp90 field have been seeking for many years: a well tolerated, highly potent Hsp90 inhibitor that is clinically active in tough-to-treat cancers,” said Dr. Neil Spector, Co-Director of Developmental Therapeutics Program, Duke University and an investigator on the trial. “Given the known role of Hsp90 in fueling breast cancer growth and metastasis, and the single-agent activity seen with ganetespib, I believe this compound has potential to be an important new therapy for women with breast cancer.”

Among the patients enrolled in the study is a 68 year old woman diagnosed with inoperable TNBC, including extensive disease that had spread to her lymph nodes. The week 3 PET scan showed metabolic response in all lesions and the week 12 physical exam showed no evidence of tumor. Treatment was adjudicated a complete clinical response, and her disease was restaged from inoperable to operable. Earlier this month, she successfully completed a mastectomy with curative intent.

“It is quite remarkable to see such a strong clinical response in this devastating disease, particularly with a single-agent regimen this well tolerated,” said Dr. Tamas Hickish, Professor at the Royal Bournemouth Hospital, Dorset, UK, the treating physician and an investigator on the study. “This outcome strongly supports the further investigation of ganetespib either as a single-agent or in combination with standard of care treatments used in this setting.”

Consistent with prior experience in over 700 patients treated with ganetespib to date, the most common adverse event seen with ganetespib in the ENCHANT-1 trial was mild to moderate, transient diarrhea, which was generally manageable with standard medication.

“These encouraging findings confirm prior signals of clinical activity seen with ganetespib in breast cancer,” said Dr. Iman El-Hariry, Vice President of Clinical Research at Synta. “The favorable safety profile, clear single-agent clinical activity, and strong rationale for combination therapy suggest ganetespib may have broad potential utility in breast cancer. Taxanes in particular are widely used in breast cancer. The positive results for the combination of ganetespib with docetaxel in lung cancer provide strong rationale for exploring the taxane combination regimen in breast cancer as well.”

The expansion of the ENCHANT-1 trial will also allow for evaluation of the combination of weekly paclitaxel and ganetespib. Separately, an investigator-sponsored study evaluating the combination of ganetespib, paclitaxel, and trastuzumab in HER2-positive patients is initiating at MSKCC and NYU.

Results from ENCHANT-1 are expected to be presented at a medical meeting later this year.

About Ganetespib

Ganetespib, an investigational drug candidate, is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone which controls the folding and activation of a number of client proteins that drive tumor development and progression. Many solid and hematologic tumors are dependent on Hsp90 client proteins including proteins involved in “oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen receptor, estrogen receptor, JAK2); proteins involved in resistance to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1, survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha, VEGFR, PDFGR, and VEGF); and proteins involved in metastasis (MET, RAF, AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of Hsp90 by ganetespib results in the inactivation, destabilization, and eventual degradation of these cancer-promoting proteins. Ganetespib is being evaluated in over 20 clinical trials including a Phase 3 trial in non-small cell lung adenocarcinoma, as well as additional trials in lung, breast, colorectal, and hematologic malignancies. Information on these trials can be found at www.clinicaltrials.gov.

About the ENCHANT-1 Clinical Trial

ENCHANT-1 is a proof-of-concept, ”window-of-opportunity” trial designed to evaluate single-agent ganetespib safety and clinical activity in locally advanced or first line metastatic HER2-positive and triple-negative breast cancer. The trial will also evaluate the combination of ganetespib with paclitaxel. More information about this trial can be found at www.clinicaltrials.gov (NCT01677455)

About Breast Cancer

Breast cancer is the most frequent cancer in women, accounting for 458,000 deaths worldwide in 2008, according to the World Health Organization. In the U.S., the American Cancer Society estimates that about 297,000 cases of breast cancer will be diagnosed in 2013. Breast cancer is often characterized in the context of three biomarkers: ER/PR positive, HER2-positive, or negative for all three (triple-negative). Standard treatment for the first two categories includes therapies targeting hormonal or HER2 signaling pathways. There are no established targeted therapies for patients with triple-negative disease, which accounts for approximately 15% of all breast cancer and is associated with poor patient prognosis.

About Synta Pharmaceuticals

Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of clinical- and preclinical-stage drug candidates with distinct mechanisms of action and novel chemical structures. All Synta drug candidates were invented by Synta scientists using our compound library and discovery capabilities. For more information, please visit www.syntapharma.com.

Safe Harbor Statement

This media release may contain forward-looking statements about Synta Pharmaceuticals Corp. Such forward-looking statements can be identified by the use of forward-looking terminology such as “will”, “would”, “should”, “expects”, “anticipates”, “intends”, “plans”, “believes”, “may”, “estimates”, “predicts”, “projects”, or similar expressions intended to identify forward-looking statements. Such statements, including statements relating to the developments and progress of our clinical and preclinical programs, reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements, including those described in “Risk Factors” of our Form 10-K for the year ended December 31, 2012 as filed with the Securities and Exchange Commission. Synta undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

Monday, July 29th, 2013 Uncategorized Comments Off on (SNTA) Announces ENCHANT-1 Breast Cancer Results

(MNTA) Announces Potential for 2014 Market Entry of Generic Copaxone®

Federal Circuit Invalidates 2015 Copaxone Patent

CAMBRIDGE, Mass., July 26, 2013 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) invalidated several Copaxone patents asserted against the company by Teva Pharmaceuticals, including the only asserted patent to expire in September 2015. Today’s decision narrows a 2012 decision by the District Court for the Southern District of New York (the “District Court”) and potentially clears the way for market entry of generic Copaxone as early as May 2014, the expiration date of the remaining asserted patents, pending U.S. Food and Drug approval (FDA).

“We are extremely pleased with today’s ruling,” said Craig Wheeler, President and Chief Executive Officer of Momenta. “Given the decision, we and Sandoz will continue to work with FDA to advance review of the ANDA for generic Copaxone in order for this product to be approved and available to patients as soon as possible.”

The case involved nine patents asserted by Teva for patent infringement associated with submission of an Abbreviated New Drug Application (ANDA) to FDA for generic Copaxone. The asserted patents included seven FDA Orange Book patents and one non-Orange Book patent expiring in May 2014 and one non-Orange Book patent expiring in September 2015. The case is Teva Pharmaceuticals v. Sandoz and Momenta and Mylan et al., case numbers 2012-1567, -1568, -1569, -1570.

In 2012, the District Court found all nine patents valid and infringed and issued injunctions enjoining FDA from approving any ANDA for generic Copaxone until May 2014, and enjoining parties in the case from making, using, offering for sale, or selling generic Copaxone until September 2015. Today’s decision means that the injunctions will be modified to reflect the Federal Circuit’s decision, potentially permitting generic Copaxone to be available to patients when remaining asserted patents covering Copaxone expire in 2014.

The ANDA for generic Copaxone is under FDA review and continues to advance. Momenta and Sandoz remain confident that the ANDA will be approved under the 505(j) pathway as an interchangeable generic Copaxone.

About M356, a generic version of Copaxone (glatiramer acetate injection)

M356 (glatiramer acetate injection) is a generic version of Copaxone, a synthetic polypeptide medicine, developed in collaboration with Sandoz and currently under review by FDA. Copaxone is prescribed for patients with relapsing-remitting multiple sclerosis, a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. Copaxone is one of the leading products marketed for treating multiple sclerosis.

About the Orange Book

The “Orange Book” is officially recognized as the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations.

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilars and potentially interchangeable biologics, and to the discovery and development of novel medicines.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.

Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

Special Note Regarding Forward-Looking Statements

Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to its beliefs and intentions related to the outcome of litigation with Teva Pharmaceuticals and our ability to achieve approval of generic Copaxone (M356) product, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “hope,” “target,” “project,” “goals,” “potential,” “predict,” “might,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 filed with the Securities and Exchange Commission under the section “Risk Factors,” as well as other documents that may be filed by Momenta from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Momenta is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Lora Pike
         Senior Director, Investor Relations and
         Corporate Communications
         lpike@momentapharma.com
         617-395-5189
Friday, July 26th, 2013 Uncategorized Comments Off on (MNTA) Announces Potential for 2014 Market Entry of Generic Copaxone®

(AEHR) Announces $2.5 Million in Orders From Leading IC Manufacturer

FREMONT, Calif., July 26, 2013 (GLOBE NEWSWIRE) — Aehr Test Systems (Nasdaq:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced it has received over $2.5 million in production orders for its burn-in and test systems from a leading manufacturer of advanced logic integrated circuits (ICs) for automotive, embedded processing, digital signal processing and analog applications. The orders include down payments to lock in delivery slots and volume pricing discounts.

The orders are for multiple Advanced Burn-in and Test Systems (ABTS™) and a follow-on MAXTM system. The ABTS systems feature a new low-cost high-volume configuration targeted at production test and burn-in of lower-power devices. This new ABTS offers the option of high voltage Device Power Supplies configurable with 60V, 80V, 150V or 230V programmable voltage ranges, which are needed for automotive and power-line applications. Shipments of this new ABTS configuration are expected to begin in the fourth quarter of calendar year 2013.

“We are pleased to receive these orders for production test and burn-in systems,” said Carl Buck, vice president of marketing at Aehr Test Systems. “The new ABTS system configuration offers over 50% more device test capacity than our previous MAX family of production test and burn-in systems. Importantly, this new ABTS is designed to allow the customer to continue to use their extensive inventory of MAX-style burn-in boards on the ABTS while also offering the increased capacity for new devices. This ABTS configuration extends the capabilities of our MAX systems by providing an increase to 128 I/O channels and 8 unique device power supplies per burn-in board, in addition to the new high-voltage supplies.

“The new configuration extends our already successful ABTS-Pi system, which features Individual Temperature Control of each device for high power applications, to provide a lower cost and higher parallel solution for automotive, standard logic and high voltage applications,” Buck concluded.

The ABTS family of products is based on a new hardware and software platform that is designed to address not only today’s devices, but also future devices for many years to come. It can test and burn-in both logic and memory devices, including resources for high pin-count devices and configurations for high-power and low-power applications. The ABTS system can be configured with up to 72 burn-in boards with up to 320 I/O channels each and 32M of test vector memory per channel. The ABTS system is optimized for use with the Sensata iSocket* Thermal Management Technology, which provides a scalable cost-effective solution using individual device temperature control for ICs up to 75 watts or more. Individual temperature control enables high-power devices with a broad range of power dissipation to be burned-in simultaneously in a single burn-in chamber while maintaining a precise device temperature. The ABTS system also uses N+1 redundancy technology for many key components in the system to maximize system uptime.

*iSocket is a trademark of Sensata Technologies, Inc.

About Aehr Test Systems

Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test products in package and wafer level test. Aehr Test has developed and introduced several innovative products, including the ABTS and FOXTM families of test and burn-in systems and the DiePak® carrier. The ABTS system is used in production and qualification testing of packaged parts for both low-power and high-power logic as well as all common types of memory devices. The FOX system is a full wafer contact test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers and systems-on-a-chip. The DiePak carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of bare die. For more information, please visit the Company’s website at www.aehr.com.

Safe Harbor Statement

This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially

from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding expected initial shipping dates of our ABTS systems. The risks and uncertainties that could cause our results to differ materially from those expressed or implied by such forward-looking statements include, without limitation, general world economic conditions and events, the state of the semiconductor equipment market, our ability to maintain sufficient cash to support operations, acceptance by customers of the ABTS technology, acceptance by customers of the ABTS systems shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing our business. The Company disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

CONTACT: Aehr Test Systems
         Carl Buck
         V.P. of Marketing
         (510) 623-9400 x381

         Financial Relations Board
         Marilynn Meek
         Analyst/Investor Contact
         (212) 827-3773
Friday, July 26th, 2013 Uncategorized Comments Off on (AEHR) Announces $2.5 Million in Orders From Leading IC Manufacturer

(ETRM) to Host Second Quarter 2013 Financial Results Conference Call

EnteroMedics to Host Second Quarter 2013 Financial Results Conference Call and Provide Business Update

ST. PAUL, MN–(Marketwired – Jul 26, 2013) – EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it will host a conference call on Wednesday, July 31, 2013 at 11:00 AM Eastern Time to discuss financial results for the second quarter ended June 30, 2013 and to provide a business update.

Conference Call Details

The conference call may be accessed by dialing (877)-280-7473 (U.S. and Canada) or (707)-287-9370 (international), and entering passcode 23024499. A replay of the call will be available from July 31, 2013 at 2:00 PM Eastern Time through October 22, 2013 at 11:59 PM Eastern Time by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) and entering passcode 23024499.

To access the live webcast, visit the events page of the investor relations section of EnteroMedics’ website at www.enteromedics.com. A replay of the webcast will be available immediately after the conference call.

About EnteroMedics Inc.

EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. EnteroMedics’ proprietary technology, VBLOC® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort. EnteroMedics’ Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial regulatory approval for our Maestro® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our preliminary findings from our EMPOWER™ and ReCharge pivotal trials; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC® vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 7, 2013. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Caution – Investigational device. Limited by Federal (United States) law to investigational use.

The implantation procedure and usage of the Maestro® System carry some risks, such as the risks generally associated with laparoscopic procedures and those related to treatment as described in the ReCharge clinical trial informed consent.

Company Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
Email Contact

Media Contact:
Sam Brown Inc.
Mike Beyer
(312) 961-2502
Email Contact

Friday, July 26th, 2013 Uncategorized Comments Off on (ETRM) to Host Second Quarter 2013 Financial Results Conference Call

(WAVX) to Complete $1.5 Million Stock Offering

LEE, MA–(Marketwired – Jul 26, 2013) – Wave Systems Corp. (NASDAQ: WAVX) (www.wave.com) today announced that on July 25, 2013 it agreed to sell to investors 1,204,470 shares of its Class A common stock at a price of $1.27 per share, yielding gross proceeds of approximately $1,529,677. The $1.27 share price reflects the closing bid price on July 24, 2013. The net proceeds of the financing will be used to fund Wave’s ongoing operations.

Security Research Associates acted as placement agent in connection with the offering. The shares sold to investors in this offering are being issued under a $30 million shelf registration statement declared effective by the Securities and Exchange Commission on July 22, 2011. A prospectus supplement related to the public offering will be filed with the Securities and Exchange Commission.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

About Security Research Associates
Security Research Associates (SRA) was founded in San Francisco in 1980 and today offers both investment banking and institutional brokerage services. A boutique firm by design, SRA works with a select group of portfolio managers from around the country and focuses on technology and life science companies in the micro and small cap arenas. For more information, visit www.sracap.com.

About Wave Systems
Wave Systems Corp. (NASDAQ: WAVX) reduces the complexity, cost and uncertainty of data protection by starting inside the device. Unlike other vendors who try to secure information by adding layers of software for security, Wave leverages the security capabilities built directly into endpoint computing platforms themselves. Wave has been a foremost expert on this growing trend, leading the way with first-to-market solutions and helping shape standards through its work as a board member for the Trusted Computing Group.

Safe Harbor for Forward-Looking Statements
This press release may contain forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the company, its directors or its officers with respect to, among other things: (i) the company’s financing plans; (ii) trends affecting the company’s financial condition or results of operations; (iii) the company’s growth strategy and operating strategy; and (iv) the declaration and payment of dividends. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the company’s ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors. Wave assumes no duty to and does not undertake to update forward-looking statements.

All brands are the property of their respective owners.

Company:
Gerard T. Feeney
CFO
info@wavesys.com
413-243-1600

Investor Relations:
David Collins, Eric Lentini
wavx@catalyst-ir.com
212-924-9800

Friday, July 26th, 2013 Uncategorized Comments Off on (WAVX) to Complete $1.5 Million Stock Offering

(GENT) Receives Positive Opinion From EMA’s CHMP for Defitelio

VILLA GUARDIA, Italy, July 26, 2013 (GLOBE NEWSWIRE) — Gentium S.p.A. (Nasdaq:GENT) (the “Company”) announced today that, following its request for re-examination, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for Defitelio recommending a Marketing Authorization Application (“MAA”) under exceptional circumstances, for the treatment of severe hepatic veno-occlusive disease (“VOD”) in adults and children undergoing hematopoietic stem cell transplantation therapy.

The European Commission (“EC”) will review the positive opinion from the CHMP, as they have the authority to grant marketing authorization. The EC generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union (EU) countries. Upon approval, each member state will then determine the individual country price and the level of reimbursement.

Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A., welcomed the decision saying “We are delighted for this positive recommendation for Defitelio. This outcome from the CHMP meeting is an important milestone for the Company and represents the culmination of a great deal of work by many people. If approved, Defitelio would become the first drug for VOD in the current treatment setting. We look forward to the ratification of the CHMP recommendation by the European Commission.”

Dr. Paul Richardson, RJ Corman Professor Of Medicine, Harvard Medical School, Clinical Director of the Jerome Lipper Multiple Myeloma Center, Dana Farber Cancer Institute, Boston, MA (USA) and principal investigator stated, “We believe that Defitelio will represent a very important therapeutic option for patients undergoing hematopoietic stem-cell transplantation. It provides a potentially life-saving treatment for severe VOD, a complication with both a very high mortality rate and for which there are no other approved therapies.”

Dr. Alejandro Madrigal, President of the European Group for Blood and Morrow Transplantation (“EBMT”), the largest professional body in field of Hematopoietic Stem Cell transplantation, said “The EBMT guidelines, prepared by over 30 leading experts, recommend Defitelio as a therapy proven to be of value in the treatment of severe VOD. The EBMT considers that the published evidence of efficacy and safety, and also the extensive clinical experience, support the value of Defitelio in the treatment of VOD.”

About Approval under Exceptional Circumstances

When the applicant can show that it is not possible to provide comprehensive data on efficacy and safety of a medicine due to the rarity of the condition it is intended for, or limited knowledge in the therapeutic area or ethical considerations involved in the collection of such data, the CHMP may recommend that a medicine is approved under “exceptional circumstances”. Also in such cases, the applicant is given obligations to fulfil, particularly relating to the safety. These are re-assessed every year until the approval can be converted into a normal one.

About VOD

Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.

About Gentium

Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company’s lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency, both to treat and to prevent VOD, as well as Fast Track Designation by the U.S. FDA to treat VOD.

Cautionary Note Regarding Forward-Looking Statements

This release contains “forward-looking statements” that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of Gentium’s securities. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company’s belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company’s control. It is possible that actual results, including with respect to the possibility of any future regulatory approval, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our Form 20-F filed with the Securities and Exchange Commission under the caption “Risk Factors.”

CONTACT: Gentium S.p.A.
         Salvatore Calabrese, +39 031-5373-260
         SVP & CFO
         scalabrese@gentium.it

         or

         The Trout Group
         Chelsea Wheeler +1 646 378 2941
         cwheeler@troutgroup.com
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(BLIN) iAPPS ds Platform Selected by Leading National ISO Network

BURLINGTON, Mass., July 25, 2013 (GLOBE NEWSWIRE) — Bridgeline Digital, Inc. (Nasdaq:BLIN), The Digital Engagement Company™, today announced that a leading national provider of outsourced, face-to-face sales teams has selected the iAPPS ds platform to power over 300 next generation, mobile-friendly websites for each of their locations throughout the United States. The customer caters to a diverse client base of companies in a wide range of industries that includes telecommunications, office products, retail, energy, and financial services. With this deployment, Bridgeline now powers nearly 5,000 customer websites on the iAPPS ds platform, the premiere solution for franchise and large dealer networks.

iAPPS ds has a proven track record providing franchises and large dealer networks a unified platform that empowers local franchisees to personalize content, improve web visibility with Search Engine Optimization (SEO), execute local marketing initiatives, measure results with analytics, and drive customer engagement online.

The iAPPS ds platform will enable the customer to easily publish and optimize web content using iAPPS Content Manager, as well as enhance the effectiveness of their web strategies through iAPPS Analyzer. Additionally, what sets the iAPPS ds platform apart from other web engagement solutions is its unique scalability. Despite the high-volume of websites deployed, iAPPS ds effortlessly enables secure brand control and messaging at a corporate level while simultaneously allowing individual administrators the ability to personalize web content to market to their local communities.

This new iAPPS ds customer will be equipped with both back- and front-end mobile capabilities. Each of their 300-plus websites will be implemented with Responsive Design capabilities, a mobile-friendly technology approach that detects the size of a visitor’s device viewing screen and triggers content to automatically adjust to fit the screen accordingly and properly render the website. The mobile-friendly platform also allows businesses to contextualize the customer experience by triggering persuasive content based on what device visitors are using to access the customer’s website. Additionally, administrators can edit and publish content on-the-go with a smart phone or tablet in the touch-capable iAPPS Content Manager user interface.

“The endless scalability franchises and large dealer networks attain through iAPPS ds is a key differentiator that separates the solution apart from other web platforms,” said Ty Glasgow, Executive Vice President of Strategic Alliance at Bridgeline Digital. “Even though iAPPS ds is a relatively new offering in the franchise and large dealer marketplace, the adoption rate of nearly 5,000 enterprise websites has been phenomenal. Never before has a web platform been able to simultaneously showcase the power of a national brand and so easily enable marketing to local communities.”

About Bridgeline Digital

Bridgeline Digital (Nasdaq:BLIN), The Digital Engagement Company™, enables its customers to maximize the performance of their mission critical websites, intranets, and online stores. Bridgeline’s iAPPS® platform deeply integrates Web Content Management, eCommerce, eMarketing, and Web Analytics to help marketers deliver online experiences that attract, engage and convert their customers across all digital channels. Bridgeline provides end-to-end Digital Engagement solutions and boasts an award-winning team of interactive services professionals. Headquartered in Burlington, Mass., with nine additional locations throughout the U.S. and an Asia Pacific headquarters in Bangalore, India, Bridgeline has thousands of customers that range from middle market organizations to Fortune 1000 companies. To learn more, please visit www.bridgelinedigital.com or call (800) 603-9936.

CONTACT: Brian Bolton
         Bridgeline Digital, Inc.
         Senior Vice President, Marketing
         781.497.3013
         bbolton@blinedigital.com
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(TRIP) Names 10 Of The Quirkiest U.S. Accommodations

Floating B&B, Giant Dog, and Desert Cave Among America’s Most Unique Properties

NEWTON, Mass., July 25, 2013 /PRNewswire/ — TripAdvisor®, the world’s largest travel site*, today announced 10 quirky  accommodations in the U.S., as chosen by TripAdvisor editors. Travelers seeking a unique lodging experience can hunker down in one of these far-out accommodations, which include a larger-than-life beagle, a historic ferry and a subterranean B&B.

“For travelers who want a truly unique experience on vacation and stories to tell for a lifetime, these funky properties will surely fit the bill,” said Brooke Ferencsik, director of communications at TripAdvisor.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/57961-tripadvisor-names-10-quirky-u-s-hotels

Caving Inn: Kokopelli Cave Bed and Breakfast, Farmington, New Mexico
Located 70 feet below the ground near the Four Corners region of the U.S., this one guestroom bed and breakfast offers more than the average digs. Travelers are invited to experience the 1,650 square foot dwelling that boasts Southwestern style furniture and decor, a full kitchen, washer/dryer, and even a relaxing flagstone hot tub. “This was a once in a lifetime experience! The cave is comfortable and has many homey touches,” commented a TripAdvisor traveler.

Variety Show: El Cosmico, Marfa, Texas
Located in the southwest region of the Lone Star state, this 18-acre property gives travelers the option to stay in a trailer, tent or teepee. Restored trailers are complete with marine-varnished birch interiors, an eclectic collection of furniture and comfortable amenities including fans, heaters, refrigerators, and cooking supplies. A TripAdvisor traveler noted, “Two nights were not nearly enough – El Cosmico is such a charming funky place, comfortable and staffed with friendly people who want to help you have a great stay.”

Ferry Tale: Yankee Ferry, Red Hook, New York
Floating on the Hudson River in the Red Hook area of Brooklyn, this 1907 steel-hulled passenger vessel invites travelers to climb aboard and rest their heads in its spacious quarters. Guests can check out the boat’s “Polka Dot Garden” that boasts a variety of veggies while enjoying magnificent views of Manhattan. “This is by far the most unique and amazing place I have ever stayed. It is unlike anything else, blending adventure, history, and a sense of home all in one,” said a TripAdvisor traveler.

Ruffing it: Dog Bark Park Inn, Cottonwood, Idaho
Travelers visiting this bed and breakfast located 200 miles north of Boise will be glad to be in the doghouse. Guests are warmly welcomed as they enter the B&B built in the shape of a giant beagle, affectionately named “Sweet Willy,” and make their way to the loft room located in the pooch’s head. Amenities include complimentary breakfast, air conditioning, and as a pet-friendly property, lots of tail-wagging fun. “Simply put this is the best place we’ve ever stayed. A noble and absurd undertaking – made with love and care – Sweet Willy was fun, silly and cozy,” said a TripAdvisor traveler.

Lighthouse Living: East Brother Light Station, Point Richmond, California
Situated on a strait between San Francisco and San Pablo Bay, this Victorian lighthouse offers a romantic, one of a kind stay. Following a 10-minute ferry ride, travelers will immerse themselves in the stunning scenery and lavish guest rooms, and relish the exquisite, fresh fare. “It’s amazing that folks pass this hidden treasure on a daily basis and have no idea of the prospect of relaxation and solitude that awaits,” commented a TripAdvisor traveler.

Back to School: McMenamins Kennedy School, Portland, Oregon
Travelers will get a lesson in some old-fashioned fun at this converted schoolhouse. Fifty-seven former classrooms, still adorned with chalkboards, now house plush beds for guests to rest to their heads. Those interested in extracurricular activities can view a movie in the former auditorium or sip a beverage at the “Detention Bar.” A TripAdvisor traveler commented, “Beyond comparison, this hotel transformed from a former school, had all of the imagined charm and then some.”

Nature Nook: Starlight Llama Bed and Breakfast, Florence, Massachusetts
Twenty miles north of Springfield in western Massachusetts, travelers can connect with nature while enjoying an off-the-grid experience. Running on solar power and recognized in the TripAdvisor GreenLeaders™ program, guests at this bed and breakfast are invited to socialize with the property’s animals including emus, peacocks, and of course, llamas. “I really enjoyed my stay here, the rooms were clean and cozy, breakfast was delicious, and the animals were pretty awesome,” commented a TripAdvisor traveler.

Train Spotting: Red Caboose Getaway, Sequim, Washington
Located at the picturesque junction of the Olympic Mountains and the Dungeness River, this locomotive lodging offers spectacular scenery atop of tracks. Travelers can climb aboard six themed caboose cars refurbished with modern amenities including mini refrigerators, hot tubs, and a collection of train-travel movies, and later enjoy a gourmet meal at the “Silver Eagle” zephyr dining car. “The decor is charming, thoughtful, railroad-authentic, playful and well appointed,” commented a TripAdvisor traveler.

Houseboat Haven: Green Turtle Floating Bed and Breakfast, Boston, Massachusetts
Moored in Boston Harbor, this floating houseboat offers travelers a comfortable rest on the water. After a day of touring nearby sites along the Freedom Trail, guests can enjoy stunning views of the Boston skyline or unwind with luxurious amenities in one of two suites that offer private bathrooms, in-room kitchenettes, and Wi-Fi. A TripAdvisor traveler commented, “It was the best night’s sleep I’ve had in months, and I felt so at ease in the comfort of this wonderful bed and breakfast.”

Masterpiece Hotel: 21c Museum Hotel Bentonville, Bentonville, Arkansas
Located 200 miles northwest of Little Rock, this boutique hotel features its own museum for true art aficionados. Travelers will marvel at the rotating collection of contemporary exhibitions and dynamic installations, and will be equally inspired by the lodging’s gracious guest rooms designed by renowned architect Deborah Berke. A TripAdvisor traveler said, “Prepare to be surprised and delighted by this intriguing hotel and museum. From check-in to check-out, no detail was too small to escape the wonderful staff.”

About TripAdvisor
TripAdvisor® is the world’s largest travel site*, enabling travelers to plan and have the perfect trip. TripAdvisor offers trusted advice from real travelers and a wide variety of travel choices and planning features with seamless links to booking tools. TripAdvisor branded sites make up the largest travel community in the world, with more than 230 million unique monthly visitors**, and more than 100 million reviews and opinions covering more than 2.7 million accommodations, restaurants and attractions. The sites operate in 30 countries worldwide, including China under daodao.com. TripAdvisor also includes TripAdvisor for Business, a dedicated division that provides the tourism industry access to millions of monthly TripAdvisor visitors.

TripAdvisor, Inc. (NASDAQ: TRIP) manages and operates websites under 20 other travel media brands: www.airfarewatchdog.com, www.bookingbuddy.com, www.cruisecritic.com, www.everytrail.com, www.familyvacationcritic.com, www.flipkey.com, www.gateguru.com, www.holidaylettings.co.uk, www.holidaywatchdog.com, www.independenttraveler.com, www.jetsetter.com, www.niumba.com,  www.onetime.com, www.seatguru.com, www.smartertravel.com, www.tingo.comwww.travelpod.com, www.virtualtourist.com, www.whereivebeen.com, and www.kuxun.cn.

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(ETRM) PMA App for VBLOC Therapy in Obesity FDA Review and Filing

EnteroMedics Announces PMA Application for VBLOC Therapy in Obesity Accepted for Review and Filing by FDA

ST. PAUL, MN–(Marketwired – Jul 25, 2013) – EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Premarket Approval (PMA) application for approval of the Maestro® Rechargeable System’s VBLOC® vagal blocking therapy as a treatment for obesity.

“The Maestro System holds the potential to fill a significant gap in the obesity treatment landscape, offering a unique, patient-friendly approach to addressing the long term challenges associated with obesity,” said Mark B. Knudson, Ph.D., EnteroMedics’ President and Chief Executive Officer. “FDA acceptance for filing of our PMA application is an important step toward this goal. We look forward to working closely with the FDA during the review process, continuing through an advisory committee panel and approval decision, as we prepare for U.S. commercialization of the Maestro System.”

As previously announced, the FDA indicated in a pre-PMA meeting that, subject to a detailed review of the submitted data, the Company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The accepted PMA application includes data from the Company’s ReCharge Pivotal Trial, a prospective, double-blind, sham-controlled clinical trial involving 239 randomized patients (233 implanted) at ten sites in the United States and Australia.

About Maestro Rechargeable (RC) System

The Maestro® RC System delivers VBLOC® vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week. The Maestro RC System has received CE Mark and has been listed on the Australian Register of Therapeutic Goods.

About the ReCharge Pivotal Trial

The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial in 239 randomized patients (233 implanted) at 10 sites testing the effectiveness and safety of VBLOC® vagal blocking therapy utilizing EnteroMedics’ second generation Maestro® Rechargeable (RC) System. All patients in the trial received an implanted device and were randomized in a 2:1 allocation to treatment or control groups. The control group received a non-functional device during the trial period. In February, EnteroMedics announced that its ReCharge Trial demonstrated a statistically significant and clinically meaningful excess weight loss (EWL) outcome and excellent safety profile. This included an average EWL of approximately 25% for VBLOC Therapy-treated patients, with over 50% of those patients achieving at least a 20% EWL. While the results demonstrated an excellent safety profile that met the pre-specified trial measures, with both a positive benefit-risk equation and a medically meaningful and clinically significant effect over the control group, the results did not meet the study’s predefined super-superiority efficacy endpoints.

About VBLOC® Therapy

EnteroMedics developed VBLOC® vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC Therapy is delivered via the Maestro® System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

About EnteroMedics Inc.

EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. EnteroMedics’ proprietary technology, VBLOC® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort. EnteroMedics’ Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial regulatory approval for our Maestro® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our preliminary findings from our EMPOWER™ and ReCharge pivotal trials; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC® vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 7, 2013. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Caution – Investigational device. Limited by Federal (United States) law to investigational use.

The implantation procedure and usage of the Maestro® System carry some risks, such as the risks generally associated with laparoscopic procedures and those related to treatment as described in the ReCharge clinical trial informed consent.

Company Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
Email Contact

Media Contact:

Sam Brown Inc.
Mike Beyer
(312) 961-2502
Email Contact

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(MDSO) Reports Record Second Quarter 2013 Results

Medidata Solutions (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced its financial results for the second quarter 2013 and provided detailed financial guidance.

“Our great execution and the growing market opportunity for the Medidata Clinical Cloud are evident in our record second quarter financial results, growing product penetration and positive outlook for the remainder of the year,” said Tarek Sherif, Medidata’s chairman and chief executive officer. “The strength of our vertical SaaS model comes from the combination of our modern cloud technology and deep domain expertise. Coupled with the industry’s richest repository of clinical trial data, Medidata’s platform is transforming clinical research.”

Second Quarter 2013 Results

  • Total revenues for the second quarter of 2013 were $68.1 million, an increase of $14.6 million, or 27%, compared with $53.5 million in 2012. Application services revenue was $56.3 million, an increase of 36% compared with the same period last year.
  • GAAP operating income for the quarter increased to $8.8 million, up 55%, compared with $5.7 million a year ago. Non-GAAP operating income* for the second quarter of 2013 increased to $17.5 million, up 60%, compared with $11.0 million a year ago.
  • GAAP net income for the second quarter of 2013 was $5.1 million, or $0.19 per diluted share, up 42%, compared with $3.6 million, or $0.14 per diluted share, in the second quarter of 2012. Adjusted non-GAAP net income* for the second quarter of 2013 was $9.5 million, or $0.36 per diluted share, up 63%, compared with $5.8 million, or $0.23 per diluted share, in the second quarter of 2012.
  • Application services backlog for the remainder of the year as of June 30, 2013, increased to $110 million, up 38% over the comparable period a year ago. Non-Rave products account for 23% of remaining backlog.
  • Total cash, cash equivalents and marketable securities were $140.4 million at the end of the second quarter, an increase of $26.5 million, or 23%, as compared with $113.9 million at the end of the second quarter 2012.
  • Cash flow from operations was a record $26.2 million in the second quarter, up 361% year-over-year.

Additional Highlights

  • Medidata’s customer base grew to 363 in the second quarter of 2013, up 15% from the second quarter of 2012.
  • 45% of customers have committed to multiple products at the end of the second quarter of 2013 as compared with 41% at the end of the first quarter of 2013.
  • Non-Rave revenues increased 144% year-over-year, driven by significant growth in Medidata’s patient randomization and trial supply, and medical coding applications.
  • Medidata’s revenue retention rate for the quarter was 99.4%.
  • Medidata announced the availability of the Medidata Clinical Cloud Study, an easy-to-acquire, ready-in-weeks offering for mid-sized and small customers, single programs and large customer pilots.

“Our revised revenue and profitability guidance continues to validate our prudent investments in sustainable growth,” said Cory Douglas, chief financial officer. “Record operating cash flow this quarter also demonstrates the long-term cash generation potential of Medidata’s highly scalable and vertically focused cloud business.”

Financial Outlook

For the full year 2013, the company now expects:

  • Revenues between $273.0 and $276.0 million.
  • Professional services revenues in the high $40 million range.
  • Non-GAAP operating income between $64.0 and $67.0 million. Based on current estimates, this would equate to GAAP operating income between $29.0 and $32.0 million.
  • Adjusted non-GAAP net income, which includes the tax affected impact primarily from stock-based compensation and amortization at a 40% effective tax rate, between $34.0 and $37.0 million. Based on current estimates, this would equate to GAAP net income between $17.5 and $20.5 million.
  • While changes in the stock price could change the fully diluted share count, the company is assuming 26.8 million fully diluted shares.

For the third quarter of 2013, the company expects:

  • Revenues between $69.5 and $71.0 million.
  • Non-GAAP operating income between $16.0 and $17.0 million. Based on current estimates, this would equate to GAAP operating income between $7.0 and $8.0 million.
  • Adjusted non-GAAP net income, which includes the tax affected impact primarily from stock-based compensation and amortization at a 40% effective tax rate, between $8.0 and $9.0 million. Based on current estimates, this would equate to GAAP net income between $3.5 and $4.5 million.
  • While changes in the stock price could change the fully diluted share count, the company is assuming 27.0 million fully diluted shares.

Conference Call

The company plans to host its investor conference call today at 8:00 a.m. Eastern. The investor conference call will be available via live webcast on the “Investor” section of Medidata’s web site at http://investor.mdsol.com. To participate by telephone, domestic participants may dial 877-303-2528 and international participants may dial 847-829-0023. Those interested in participating in the conference call should dial in at least 10 minutes prior to the call to register. Participants can also join the call via a simultaneous live audio webcast, which will be made available on the “Investor” section of Medidata’s web site at http://investor.mdsol.com. A replay of the conference call can be accessed until Thursday, August 8, 2013, by dialing 800-585-8367 domestically or 404-537-3406 internationally, with the passcode 17553261. An archive of the call will also be hosted on the “Investor” section of Medidata’s web site, http://investor.mdsol.com, for a limited period of time.

About Medidata Solutions

Medidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

Cautionary Statement

Certain statements made in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Medidata Solutions, Inc. (“Medidata”), including but not limited to statements about Medidata’s forecast of financial performance, products and services, business model, strategy and growth opportunities, and competitive position. Such statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. In particular, the risks and uncertainties include, among other things, risks associated with possible fluctuations in our financial and operating results; errors, interruptions or delays in our service or our Web hosting; the financial impact of any future acquisitions; our ability to continue to release, and gain customer acceptance of, new and improved versions of our products; changes in our sales and implementation cycles; competition; our ability to retain and expand our customer base or increase new business from those customers; our ability to hire, retain and motivate our employees and manage our growth; regulatory developments; litigation; and general developments in the economy. For additional disclosure regarding these and other risks faced by the company, see disclosures contained in Medidata’s public filings with the Securities and Exchange Commission including, the “Risk Factors” section of Medidata’s Annual Report on Form 10-K for the year ended December 31, 2012. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and Medidata undertakes no obligation to update such statements as a result of new information.

*Non-GAAP Financial Information

Medidata provides Non-GAAP operating income, net income and net income per share applicable to common stockholders data as additional information for its operating results. These measures are not in accordance with, or an alternative for, generally accepted accounting principles and may be different from Non-GAAP measures used by other companies. Non-GAAP operating income excludes the impact of depreciation, amortization of intangible assets associated with acquisitions, stock-based compensation expense, and an adjustment to the fair value of contingent consideration. Non-GAAP net income excludes the impact of amortization of intangible assets associated with acquisitions, stock-based compensation expense, and an adjustment to the fair value of contingent consideration. Adjusted non-GAAP net income excludes the impact of tax-affected amortization of intangible assets associated with acquisitions, stock-based compensation expense, and an adjustment to the fair value of contingent consideration. Management uses these Non-GAAP measures to evaluate its financial results, develop budgets, manage expenditures, and as an important factor in determining variable compensation. In addition, investors frequently have requested information from management regarding depreciation and amortization and non-cash, share-based compensation charges, and management believes, based on discussions with investors, that these Non-GAAP measures enhance investors’ ability to assess Medidata’s historical and project future financial performance. While management believes these Non-GAAP financial measures provide useful supplemental information to investors, there are limitations associated with the use of Non-GAAP financial measures. One limitation of Non-GAAP operating income is that it excludes depreciation and amortization, which represents the periodic costs of certain capitalized tangible and intangible assets used in generating revenues in our business. Medidata compensates for these limitations by using these Non-GAAP financial measures as supplements to GAAP financial measures and by reviewing the reconciliations of the Non-GAAP financial measures to their most comparable GAAP financial measures. Investors are encouraged to review the reconciliations of these Non-GAAP financial measures to the comparable GAAP results, which are attached to this press release.

MEDIDATA SOLUTIONS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(Amounts in thousands, except per share data)
Three Months Ended June 30, Six Months Ended June 30,
2013 2012 2013 2012
Revenues
Application services $ 56,346 $ 41,541 $ 106,998 $ 79,937
Professional services 11,723 11,972 24,330 23,935
Total revenues 68,069 53,513 131,328 103,872
Cost of revenues (1)(2)
Application services 8,949 8,213 17,974 15,697
Professional services 7,971 7,562 16,075 14,693
Total cost of revenues 16,920 15,775 34,049 30,390
Gross profit 51,149 37,738 97,279 73,482
Operating costs and expenses:
Research and development (1) 12,105 10,628 24,010 20,583
Sales and marketing (1)(2) 16,253 12,263 30,742 22,646
General and administrative (1) 13,955 9,159 26,599 18,449
Total operating costs and expenses 42,313 32,050 81,351 61,678
Operating income 8,836 5,688 15,928 11,804
Interest and other income (expense):
Interest expense (27 ) (28 ) (45 ) (49 )
Interest income 59 60 135 131
Other (expense) income, net (10 ) (10 ) 144 (10 )
Total interest and other income, net 22 22 234 72
Income before income taxes 8,858 5,710 16,162 11,876
Provision for income taxes 3,752 2,106 5,356 4,502
Net income $ 5,106 $ 3,604 $ 10,806 $ 7,374
Earnings per share:
Basic $ 0.20 $ 0.15 $ 0.43 $ 0.30
Diluted $ 0.19 $ 0.14 $ 0.41 $ 0.29
Weighted average common shares outstanding:
Basic 25,425 24,406 25,273 24,212
Diluted 26,744 25,277 26,528 25,082
(1) Stock-based compensation expense included in cost of revenues and operating costs and expenses is as follows:
Cost of revenues $ 838 $ 514 $ 1,325 $ 809
Research and development 627 307 1,085 498
Sales and marketing 1,722 803 2,944 1,367
General and administrative 3,937 1,534 6,975 2,638
Total stock-based compensation $ 7,124 $ 3,158 $ 12,329 $ 5,312
(2) Amortization expense of intangible assets included in costs of revenues and operating costs and expenses is as follows:
Cost of revenues $ 101 $ 319 $ 382 $ 637
Sales and marketing 33 129 146 258
Total amortization of intangible assets $ 134 $ 448 $ 528 $ 895

 

MEDIDATA SOLUTIONS, INC.
Reconciliation of GAAP Operating Income and GAAP Net Income toNon-GAAP Operating Income, Non-GAAP Net Income, and Adjusted Non-GAAP Net Income (Unaudited)
(Amounts in thousands, except per share data)
Three Months Ended June 30, Six Months Ended June 30,
2013 2012 2013 2012
Operating income:
GAAP operating income $ 8,836 $ 5,688 $ 15,928 $ 11,804
GAAP operating margins 13.0 % 10.7 % 12.1 % 11.4 %
Stock-based compensation 7,124 3,158 12,329 5,312
Depreciation and amortization 1,473 2,034 3,324 4,028
Contingent consideration adjustment (1) 60 80 120 160
Non-GAAP operating income $ 17,493 $ 10,960 $ 31,701 $ 21,304
Non-GAAP operating margins 25.7 % 20.5 % 24.1 % 20.5 %
Net income:
GAAP net income $ 5,106 $ 3,604 $ 10,806 $ 7,374
Stock-based compensation 7,124 3,158 12,329 5,312
Amortization 134 448 528 895
Contingent consideration adjustment (1) 60 80 120 160
Non-GAAP net income 12,424 7,290 23,783 13,741
Tax impact on add-back items (2) (2,927 ) (1,475 ) (5,191 ) (2,547 )
Adjusted non-GAAP net income $ 9,497 $ 5,815 $ 18,592 $ 11,194
GAAP basic earnings per share $ 0.20 $ 0.15 $ 0.43 $ 0.30
GAAP diluted earnings per share $ 0.19 $ 0.14 $ 0.41 $ 0.29
Non-GAAP basic earnings per share $ 0.49 $ 0.30 $ 0.94 $ 0.57
Non-GAAP diluted earnings per share $ 0.46 $ 0.29 $ 0.90 $ 0.55
Adjusted Non-GAAP basic earnings per share $ 0.37 $ 0.24 $ 0.74 $ 0.46
Adjusted Non-GAAP diluted earnings per share $ 0.36 $ 0.23 $ 0.70 $ 0.45
(1) Amount represents the effect of changes in fair value of contingent consideration liability.
(2) Tax impact calculated using a 40% tax rate.
The table above presents a reconciliation of GAAP to non-GAAP operating income, net income, and net income per share applicable to common stockholders for the three and six months ended June 30, 2013, and 2012. Non-GAAP operating income excludes the impact of depreciation, amortization of intangible assets associated with acquisitions, stock-based compensation expense, and adjustment to the fair value of contingent consideration. Non-GAAP net income excludes the impact of amortization of intangible assets associated with acquisitions, stock-based compensation expense, and adjustment to the fair value of contingent consideration. Adjusted non-GAAP net income excludes the impact of tax affected amortization of intangible assets associated with acquisitions, stock-based compensation expense, and adjustment to the fair value of contingent consideration.

 

MEDIDATA SOLUTIONS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(Amounts in thousands, except per share data)
June 30, 2013 December 31, 2012
ASSETS
Current assets:
Cash and cash equivalents $ 38,560 $ 32,683
Marketable securities 101,820 89,871
Accounts receivable, net of allowance for doubtful accounts of $1,098 and $747, respectively 41,639 42,359
Prepaid commission expense 3,230 2,281
Prepaid expenses and other current assets 9,203 8,042
Deferred income taxes 3,558 7,465
Total current assets 198,010 182,701
Restricted cash 388
Furniture, fixtures and equipment, net 14,017 10,474
Goodwill 15,087 15,382
Intangible assets, net 1,099 1,708
Deferred income taxes, long-term 10,760 11,055
Other assets 2,347 2,923
Total assets $ 241,320 $ 224,631
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,781 $ 2,998
Accrued payroll and other compensation 12,034 14,140
Accrued expenses and other 9,329 6,674
Deferred revenue 50,431 50,348
Capital lease obligations 56 55
Total current liabilities 73,631 74,215
Noncurrent liabilities:
Deferred revenue, less current portion 3,452 4,323
Deferred tax liabilities 280 624
Capital lease obligations, less current portion 72 100
Other long-term liabilities 3,008 3,278
Total noncurrent liabilities 6,812 8,325
Total liabilities 80,443 82,540
Commitments and contingencies
Stockholders’ equity:
Preferred stock, par value $0.01 per share; 5,000 shares authorized, none issued and outstanding
Common stock, par value $0.01 per share; 100,000 shares authorized, 27,235 and 26,405 shares issued; 26,658 and 26,039 shares outstanding, respectively 272 264
Additional paid-in capital 180,106 160,637
Treasury stock, 577 and 366 shares, respectively (16,088 ) (5,626 )
Accumulated other comprehensive loss (1,098 ) (63 )
Accumulated deficit (2,315 ) (13,121 )
Total stockholders’ equity 160,877 142,091
Total liabilities and stockholders’ equity $ 241,320 $ 224,631

 

MEDIDATA SOLUTIONS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(Amounts in thousands)
Six Months Ended June 30,
2013 2012
Cash flows from operating activities:
Net income $ 10,806 $ 7,374
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 3,324 4,028
Stock-based compensation 12,329 5,312
Amortization of discounts or premiums on marketable securities 1,001 601
Deferred income taxes 3,883 3,328
Amortization of debt issuance costs 30 30
Excess tax benefit associated with equity awards (997 ) (677 )
Contingent consideration adjustment 120 160
Provision for doubtful accounts 657 (36 )
Changes in operating assets and liabilities:
Accounts receivable 3,274 (10,631 )
Prepaid commission expense (830 ) (245 )
Prepaid expenses and other current assets 1,153 (2,670 )
Other assets (78 ) (1,406 )
Accounts payable (900 ) (1,238 )
Accrued payroll and other compensation (2,338 ) (708 )
Accrued expenses and other 1,183 656
Deferred revenue (4,140 ) 4,570
Other long-term liabilities 591 (225 )
Net cash provided by operating activities 29,068 8,223
Cash flows from investing activities:
Purchase of furniture, fixtures and equipment (6,761 ) (3,245 )
Purchase of available-for-sale marketable securities (78,255 ) (36,323 )
Proceeds from sale of available-for-sale marketable securities 65,272 43,007
Decrease in restricted cash 388
Net cash (used in) provided by investing activities (19,356 ) 3,439
Cash flows from financing activities:
Proceeds from exercise of stock options 6,150 4,636
Excess tax benefit associated with equity awards 997 677
Payment of acquisition-related earn-out (380 ) (251 )
Repayment of obligations under capital leases (27 ) (85 )
Acquisition of treasury stock (10,461 ) (3,128 )
Repayment of notes payable (38 )
Net cash (used in) provided by financing activities (3,759 ) 1,849
Net increase in cash and cash equivalents 5,953 13,511
Effect of exchange rate changes on cash and cash equivalents (76 ) (2 )
Cash and cash equivalents – Beginning of period 32,683 45,214
Cash and cash equivalents – End of period $ 38,560 $ 58,723

 

Thursday, July 25th, 2013 Uncategorized Comments Off on (MDSO) Reports Record Second Quarter 2013 Results

(ALCS) Enters Definitive Agreement to Be Acquired by Argonne Capital

ABILENE, Kan., July 25, 2013 (GLOBE NEWSWIRE) — ALCO Stores, Inc. (Nasdaq:ALCS) (“ALCO” or the “Company”), a general merchandise retailer specializing in providing a superior selection of essential products for everyday life in small-town America, and Argonne Capital Group LLC (“Argonne”), a private investment firm based in Atlanta, Georgia, today announced that the companies have entered into a definitive merger agreement. Under the terms of the merger agreement, Argonne will acquire all of the outstanding shares of ALCO Stores’ common stock for $14.00 per share in cash. This price represents a premium of approximately 63 percent to ALCO’s share price on July 24, 2013, the last trading day prior to ALCO’s announcement of the transaction contemplated by the merger agreement. The cash price for ALCO shares in the proposed transaction totals approximately $47 million.

The independent members of ALCO Stores’ Board of Directors have unanimously approved the merger agreement and recommended that ALCO Stores’ shareholders approve the transaction.

“Argonne Capital is very selective in its acquisition process and focuses on companies that have strong growth potential,” Royce Winsten, Chairman of the Board of ALCO, stated. “We are proud of ALCO’s CEO Rich Wilson and his management team, and how they have positioned the Company for growth. We believe Argonne will help ALCO grow and achieve the goals management and the Board have established for the Company.”

Rich Wilson, Chief Executive Officer, commented: “ALCO Stores has a unique model for providing an attractive merchandise selection and exceptional value to consumers in underserved communities in small-town America. Our associates are supportive of the new brands, variety and value we offer shoppers – as well as the operational improvements behind the scenes. ALCO looks forward to partnering with Argonne, and we believe the support they will provide will accelerate the Company’s plans for sustained growth.”

Argonne Founder and President Michael Klump added, “We are excited about the opportunity to acquire ALCO Stores, which is a strongly-positioned business that has taken the right steps to move the Company forward in today’s highly competitive retail environment. The acquisition of ALCO would be a clear strategic fit within our existing portfolio of companies and real estate investments serving the dining and retail needs of everyday Americans.”

The merger, which is expected to close later this year, is subject to approval from ALCO’s shareholders and other customary closing conditions. Under the terms of the merger agreement, the Company may solicit alternative proposals from third parties at least through August 23, 2013. The Company does not anticipate that it will disclose any developments with regard to this solicitation process unless and until the ALCO Board of Directors makes a decision with respect to any potential superior proposal. There is no assurance that this process will result in a superior proposal.

The transaction is being made through one of Argonne’s affiliates.

William Blair & Company, L.L.C. is serving as financial advisor to the Company, and Norton Rose Fulbright and Lathrop & Gage LLP are serving as legal advisors to the Company. Sagent Advisors, LLC is serving as financial advisor to Argonne, and King & Spalding LLP is serving as legal advisor to Argonne.

About ALCO Stores, Inc.

Founded in 1901, ALCO Stores, Inc. is a broad-line retailer, primarily serving small underserved communities across 23 states, which specializes in providing a superior selection of essential products for everyday life in small-town America. The Company has 213 ALCO stores that offer both name brand and private label products of exceptional quality at reasonable prices. ALCO is proud to have continually provided friendly, personal service to its customers for the past 112 years. ALCO has its distribution center in Abilene, Kansas, and is in the process of moving its headquarters from Abilene to suburban Dallas, Texas. To learn more about the Company visit www.ALCOstores.com.

About Argonne Capital Group, LLC

Argonne is a private investment firm founded in 2003 that seeks to acquire and grow companies primarily within the restaurant and retail industries that will benefit from the firm’s capital resources, operational expertise and extensive real estate knowledge and capabilities. Today, Argonne operates or franchises over 775 restaurants under brands such as IHOP, Applebee’s, Krystal and Stevi B’s Pizza. Spanning 14 states, Argonne’s restaurant portfolio employed over 20,000 people and generated in excess of $1 billion in annual system sales in fiscal year 2012. Argonne’s real estate investment platform, RCG Ventures, LLC, owns over 60 shopping center assets across 18 states with a focus on value-add opportunities. For more information about Argonne, visit www.argonnecapital.com.

Forward-looking statements

All of the statements in this release, other than historical facts, are forward-looking statements made in reliance upon the safe harbor of the Private Securities Litigation Reform Act of 1995, including, without limitation, the statements made concerning the Company’s intent to consummate a merger with an affiliate of Argonne. Forward-looking statements can be identified by the inclusion of “will,” “believe,” “intend,” “expect,” “plan,” “project” and similar future-looking terms. You should not rely unduly on these forward-looking statements. These forward-looking statements reflect management’s current views and projections regarding economic conditions, retail industry environments, and Company performance. Forward-looking statements inherently involve risks and uncertainties, and, accordingly, actual results may vary materially. Among others, the following uncertainties and other factors could cause actual results to differ from those set forth in the forward-looking statements: (i) the risk that the merger may not be consummated in a timely manner, if at all; (ii) the risk that the definitive merger agreement may be terminated in circumstances that require the Company to pay Argonne a termination fee of $2.25 million or reimbursement of their expenses of up to $1 million; (iii) risks related to the diversion of management’s attention from the Company’s ongoing business operations; (iv) risks regarding the failure of the relevant Argonne affiliate to obtain the necessary equity and debt financing to complete the merger; (v) the effect of the announcement of the merger on the Company’s business relationships (including, without limitation, customers and suppliers), operating results and business generally; and (vi) risks related to obtaining any consents to the merger. Further risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements are set forth under “Risk Factors” in the Company’s Form 10-K for the fiscal year ended February 3, 2013, and its subsequent quarterly reports on Form 10-Q. The Company does not undertake, and hereby disclaims, any duty to update these forward-looking statements, although its situation and circumstances may change in the future.

Additional Information and Where to Find It

In connection with the merger, the Company intends to file relevant materials with the Securities and Exchange Commission (the “SEC”), including a preliminary proxy statement on Schedule 14A. Promptly after filing its definitive proxy statement with the SEC, the Company will mail the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the merger. INVESTORS AND SECURITY HOLDERS OF THE COMPANY ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE MERGER THAT THE COMPANY WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE MERGER. The definitive proxy statement, the preliminary proxy statement and other relevant materials in connection with the merger (when they become available), and any other documents filed by the Company with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC at the Company’s website, www.alcostoresinc.com, or by requesting them in writing or by telephone from us at ALCO Stores, Inc., Attn: Corporate Secretary, 401 Cottage Street, Abilene, Kansas 67410-2832, (785) 263-3350 ext. 290.

The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the Company’s stockholders with respect to the merger. Information about the Company’s directors and executive officers and their ownership of the Company’s common stock is set forth in the proxy statement for the Company’s 2013 Annual Meeting of Shareholders, which was filed with the SEC on May 10, 2013. Information regarding the identity of the potential participants, and their direct or indirect interests in the merger, by security holdings or otherwise, will be set forth in the proxy statement and other materials to be filed with SEC in connection with the merger.

CONTACT: For more information, contact:
         Wayne S. Peterson
         Senior Vice President - Chief Financial Officer
         785-263-3350 X164
         email: wpeterson@alcostores.com
         or
         Debbie Hagen
         Hagen and Partners
         913-642-6363
         email: dhagen@hagenandpartners.com
Thursday, July 25th, 2013 Uncategorized Comments Off on (ALCS) Enters Definitive Agreement to Be Acquired by Argonne Capital

(ONTX) Onconova Announces Pricing of Initial Public Offering

Onconova Therapeutics, Inc., today announced the pricing of its initial public offering of 5,166,667 shares of its common stock at a public offering price of $15.00 per share, before underwriting discounts. All of the shares of common stock are being offered by Onconova. In addition, Onconova has granted the underwriters a 30-day option to purchase up to an additional 775,000 shares of common stock at the same price to cover over-allotments, if any. The shares are expected to begin trading on The NASDAQ Global Market on July 25, 2013 under the ticker symbol “ONTX.”

The offering is expected to close on July 30, 2013, subject to customary closing conditions.

Citigroup and Leerink Swann are acting as joint bookrunning managers for the offering. Piper Jaffray and Janney Montgomery Scott are acting as co-managers.

A registration statement relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on July 24, 2013. The offering is being made only by means of a prospectus, copies of which may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by email at batprospectusdept@citi.com, or by phone at 1-800-831-9146; or from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, or by phone at 1-800-808-7525, ext. 4814, or by email at Syndicate@leerink.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova’s clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In addition to rigosertib, the Company’s most advanced product candidate, two other candidates are in clinical trials, and several candidates are in pre-clinical stages.

Thursday, July 25th, 2013 Uncategorized Comments Off on (ONTX) Onconova Announces Pricing of Initial Public Offering

(ADXSD) Advaxis Updates Business Outlook for 2013

Advaxis, Inc. (OTCBB: ADXS and ADXSD) (the “Company”), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced an updated business outlook for 2013, which includes the development of its clinical strategy to advance its lead product candidate, ADXS-HPV, to registrational trials. The Company has also generated additional encouraging data and continues to strengthen its financial position.

Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis, stated, “Earlier in the year, Advaxis stated that it would provide periodic updates to its business outlook and announced two overarching objectives for 2013: one, to advance our lead product candidate, ADXS-HPV, toward a registration development program and, two, to continue to significantly strengthen our financial position. We have outlined the progress the Company has made on these two goals, as well as anticipated 2013 milestone events.”

Anticipated 2013 Milestone Events

  • A determination with respect to the Company’s three applications for Orphan Drug Designations with the FDA for ADXS-HPV in three human papillomavirus (HPV)-associated indications: invasive cervical cancer, anal cancer, and head and neck cancer;
  • Initiate dialogue with the FDA to discuss ADXS-HPV clinical development plans for the treatment of cervical cancer;
  • Complete the elements required to file an Investigational New Drug (IND) application with the FDA for ADXS-PSA for the treatment of prostate cancer in the first half of 2014;
  • Advance the canine osteosarcoma study into Phase 2 and expand to additional collaborative academic centers; and
  • File an initial listing application for the NASDAQ Capital Market or NYSE AMEX.

2013 Clinical Program Update

  • Final 12-month survival data from the Phase 2 cervical cancer trial announced at the 2013 ASCO Annual Meeting in Chicago in June;
  • GOG 0265 safety run-in completed and study opened to the GOG group-wide;
  • 16 patients enrolled in REALISTIC head and neck cancer trial;
  • 3 patients enrolled and dosed in BrUOG 276 anal cancer study; and
  • Third dose cohort underway in the canine osteosarcoma study.

Phase 2 Cervical Cancer Program

In June 2013, the Company submitted an Application for Orphan Drug Designation with the FDA Office of Orphan Products Development for ADXS-HPV for the treatment of human papillomavirus (HPV)-associated invasive cervical cancer.

In June 2013, the final 12-month survival and updated safety data from the ongoing Phase 2 study that is being conducted in India in 110 patients with recurrent cervical cancer were presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary efficacy data continue to show apparent prolonged survival, durable complete and partial tumor reductions, as well as stable disease with ADXS-HPV alone or in combination with cisplatin. 41% (45/110) of patients experienced 104 mild-moderate Grade 1-2 adverse events. 2% (2/110) of patients experienced a Grade 3 serious adverse event, compared to a rate of 130% or more in published studies of active chemotherapy regimens in this disease setting.

The Company has made substantial progress in analyzing the Phase 2 data and is planning a study to determine the best dose and dosing regimen to enhance efficacy without compromising the encouraging preliminary safety profile already observed.

In July, the Company’s clinical team met with global thought leaders in cervical cancer and, under their advisement, are developing the regulatory strategy for the Phase 3 registration approval most clinically relevant to the use of ADXS-HPV and how it can best fit among the treatment options for women with cervical cancer.

The Gynecologic Oncology Group (GOG) of the National Cancer Institute (NCI) continues to conduct a single arm Phase 2 study of ADXS-HPV in 67 patients with recurrent/refractory cervical cancer. As of July 2013, 10 patients have been enrolled in the safety run-in portion of the study.

Head and Neck Cancer Program

In June 2013, the Company submitted an Application for Orphan Drug Designation with the FDA Office of Orphan Products Development for ADXS-HPV for the treatment of human papillomavirus (HPV)-associated head and neck cancer.

Cancer Research UK (CRUK) is funding a Phase 1/2 to evaluate the use of ADXS-HPV for the treatment of 27 patients with HPV positive head and neck cancer. This trial is being conducted at the Aintree Hospital at the University of Liverpool, the Royal Marsden Hospital at the University of London, and the Cardiff Hospital at the University of Wales. As of July 2013, 16 patients have been enrolled in the study.

Anal Cancer Program

In June 2013, the Company submitted an Application for Orphan Drug Designation with the FDA Office of Orphan Products Development for ADXS-HPV for the treatment of human papillomavirus (HPV)-associated anal cancer.

The Brown University Oncology Group (BrUOG) is funding and coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer. The trial is being conducted at the Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). As of July 2013, 3 patients have been enrolled in the study. Multiple institutions will collaborate.

Prostate Cancer Program

The Company expects to file an IND with the FDA for ADXS-PSA in the treatment of prostate cancer in the first half of 2014. In June 2011, the Company conducted a pre-IND meeting with the FDA to discuss the CMC, pharmacology, toxicology, and clinical plans for ADXS-PSA. The required toxicology studies have been completed and data analyses are ongoing.

Canine Osteosarcoma Program

The Company recently announced preliminary data from a Phase 1/2 study that is being conducted at the University of Pennsylvania School of Veterinary Medicine evaluating ADXS-cHER2 for the treatment of dogs with osteosarcoma. Canine osteosarcoma is a leading killer of large breed dogs that causes tumors to form on long leg bones. The standard of care (SOC) is immediate limb amputation followed by chemotherapy and sometimes radiation, however, the cancer typically metastasizes to the lungs, causing death in 6-12 months. In this trial, dogs that have undergone SOC for osteosarcoma, and over-express HER-2/neu in their tumors, are treated with ADXS-cHER2.

Updated preliminary data show a significant survival advantage for 9 dogs that received SOC plus ADXS-cHER2 compared to 11 dogs, whose owners elected not to participate in the trial, but who were followed for survival (p=0.04). At this point in the study, 8 of 9 dogs treated with ADXS-cHER2 are alive (mean survival undefined), compared with 5 of 11 dogs in the control group (mean survival 265 days).

Plans are to expand the study into Phase 2 and to open the study to additional collaborative academic centers.

Regulatory Outlook

The Company has assembled and met with an advisory board of key thought leaders in cervical cancer and is in the process of developing the regulatory strategy and Phase 3 clinical protocols necessary to support a request for an FDA meeting to discuss the clinical development plan for ADXS-HPV.

The Company is compiling the elements required to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for ADXS-PSA for the treatment of prostate cancer in the first half of 2014.

Corporate Development Update

In July 2013, David Sidransky, MD, was appointed to the Board of Directors of the Company. Dr. Sidransky has a very strong background in both the business and science of oncology, with a specialty in head and neck cancer. Dr. Sidransky is the Director of the Head and Neck Cancer Research Division and Professor of Oncology, Otolaryngology, Genetics, and Pathology at Johns Hopkins University School of Medicine and has served on the board of directors and as an employee of numerous biotechnology companies.

Business Development Outlook

Advaxis has entered into several confidentiality agreements with biopharmaceutical companies for the license of ADXS-HPV in the U.S., Asia, and India. So far, these discussions have resulted in one memorandum of understanding and a proposed non-binding term sheet with major regional pharmaceutical companies for Asia and India. These preliminary terms establish the commercial parameters of a potential licensing deal. The Company plans to pursue these negotiations to closure in the coming months.

Advaxis has also entered into a confidentiality agreement with the animal health division of a major pharmaceutical company for the license of ADXS-cHER2. The Company plans to pursue discussions with the goal of entering into a licensing agreement. Discussions with other companies are ongoing.

Corporate Outlook

At the annual meeting of stockholders in June, stockholders approved the effect of a reverse stock split and a decrease in authorized shares of the Company at the discretion of the Board of Directors. In July, Advaxis executed the reverse stock split at a ratio of 1-for-125 and decreased the number of authorized shares from 1,000,000,000 to 25,000,000.

The Company intends to seek an uplisting to a national exchange in the near term. We have explained in our recent SEC filings why uplisting to a national market is important to our overall business strategy and financial viability. The Company strongly believes that the combination of completing the reverse stock split and the contemplated uplisting could heighten the interest of the financial community in Advaxis, as well as potentially broaden the pool of investors that may consider investing in the Company, while strengthening its financial health.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein(s) that is designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

ADXS-HPV is currently being evaluated in four clinical trials for human papillomavirus (HPV)-associated cancers: recurrent/refractory cervical cancer (India), locally advanced cervical cancer (GOG/NCI U.S. study, Clinical Trials.gov Identifier NCT01266460), head & neck cancer (CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study, Clinical Trials.gov Identifier NCT01671488). Advaxis has over 15 distinct immunotherapies in various stages of development, developed directly by Advaxis and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institutet, and others.

http://www.qualitystocks.net/content/clients/adxs.png

For more information please visit: www.advaxis.com

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements as to the anticipated timing of clinical studies and other business developments, statements as to the development of new constructs, expectations as to the adequacy of our cash balances to support our operations for specified periods of time and as to the nature and level of cash expenditures, expectations as to market opportunities, our ability to take advantage of those opportunities, and the risk factors set forth from time to time in Advaxis’ SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Thursday, July 25th, 2013 Uncategorized Comments Off on (ADXSD) Advaxis Updates Business Outlook for 2013

(FFIV) Announces Third Quarter 2013 Results

F5 Networks, Inc. (NASDAQ: FFIV) today announced revenue of $370.3 million for the third quarter of fiscal 2013, up 6 percent from $350.2 million in the prior quarter and 5 percent from $352.6 million in the third quarter of fiscal 2012.

GAAP net income for the third quarter was $68.2 million ($0.86 per diluted share) compared to $63.4 million ($0.80 per diluted share) in the second quarter of 2013 and $72.3 million ($0.91 per diluted share) in the third quarter a year ago.

Excluding the impact of stock-based compensation and amortization of purchased intangible assets, non-GAAP net income for the third quarter was $88.4 million ($1.12 per diluted share), compared to $84.7 million ($1.07 per diluted share) in the prior quarter and $90.6 million ($1.14 per diluted share) in the third quarter of fiscal 2012.

A reconciliation of GAAP net income to non-GAAP net income is included on the attached Consolidated Statements of Operations.

“Results for the third quarter exceeded our expectations,” said John McAdam, F5 president and chief executive officer. “Strong sales in the Americas led to a 6 percent sequential increase in both product and overall revenue.

“Product sales during the quarter were driven by growing demand for our BIG-IP 4000 appliances and our new entry-level BIG-IP 2000 series. In late June, we released our new midrange BIG-IP 5000 and BIG-IP 7000 series appliances, and initial customer response has been very encouraging.

“The significant performance and scalability enhancements of the new appliances have helped drive growing sales of our security software, including our new Advanced Firewall Manager and our recently upgraded Application Security Manager and Access Policy Manager. Sales of our other software modules have also grown, and demand for our software-only virtual edition products has increased steadily. Along with major enhancements to TMOS, designed to strengthen our SDN integration and cloud scaling capabilities, we recently introduced new 5-gigabit versions of our virtual edition products which run on all major hypervisors including AWS,” McAdam said.

Positive customer response to the company’s new products has contributed to a strong and growing sales pipeline. In spite of ongoing weakness in the global economy, McAdam said he believes that demand for the new products in combination with other business drivers could be a significant catalyst for continued growth.

For the fourth quarter of fiscal 2013, ending September 30, the company has set a revenue target of $378 million to $388 million and a GAAP earnings target of $0.93 to $0.96 per diluted share. Management’s GAAP earnings target includes an anticipated charge of $2.5 million related to a loss on a facility sublease. Excluding this charge, as well as stock-based compensation expense and amortization of purchased intangible assets, the company’s non-GAAP earnings target is $1.17 to $1.20 per diluted share. A reconciliation of the company’s expected GAAP and non-GAAP earnings is provided in the following table:

Three months ended
September 30, 2013
Reconciliation of Expected Non-GAAP Fourth Quarter Earnings Low High
Net income $ 73.0 $ 75.4
Stock-based compensation expense $ 22.0 $ 22.0
Amortization of purchased intangible assets $ 1.0 $ 1.0
Loss on facility sublease $ 2.5 $ 2.5
Tax effects related to above items ($ 6.6 ) ($ 6.6 )
Non-GAAP net income excluding stock-based compensation expense,
amortization of purchased intangible assets and loss on facility sublease $ 91.9 $ 94.3
Net income per share – diluted $ 0.93 $ 0.96
Non-GAAP net income per share – diluted $ 1.17 $ 1.20

About F5 Networks

F5 Networks (NASDAQ: FFIV) makes the connected world run better. F5 helps organizations meet the demands and embrace the opportunities that come with the relentless growth of voice, data, and video traffic, mobile workers, and applications—in the data center, the network, and the cloud. The world’s largest businesses, service providers, government entities, and consumer brands rely on F5’s intelligent services framework to deliver and protect their applications and services while ensuring people stay connected. Learn more at www.f5.com.

You can also follow @f5networks on Twitter or visit us on Facebook for more information about F5, its partners, and technology. For a complete listing of F5 community sites, please visit www.f5.com/news-press-events/web-media/community.html.

Forward Looking Statements

Statements in this press release concerning the continuing strength of F5’s business, sequential growth, the target revenue and earnings range, share amount and share price assumptions, demand for application delivery networking and storage virtualization products and other statements that are not historical facts are forward-looking statements. Such forward-looking statements involve risks and uncertainties, as well as assumptions and other factors that, if they do not fully materialize or prove correct, could cause the actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to: customer acceptance of our new traffic management, security, application delivery, WAN optimization and storage virtualization offerings; the timely development, introduction and acceptance of additional new products and features by F5 or its competitors; competitive pricing pressures; increased sales discounts; uncertain global economic conditions which may result in reduced customer demand for our products and services and changes in customer payment patterns; F5’s ability to sustain, develop and effectively utilize distribution relationships; F5’s ability to attract, train and retain qualified product development, marketing, sales, professional services and customer support personnel; F5’s ability to expand in international markets; the unpredictability of F5’s sales cycle; the share repurchase program; future prices of F5’s common stock; and other risks and uncertainties described more fully in our documents filed with or furnished to the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available as of the date hereof and qualified in their entirety by this cautionary statement. F5 assumes no obligation to revise or update these forward-looking statements.

GAAP to non-GAAP Reconciliation

F5’s management evaluates and makes operating decisions using various operating measures. These measures are generally based on the revenues of its products, services operations and certain costs of those operations, such as cost of revenues, research and development, sales and marketing and general and administrative expenses. One such measure is net income excluding stock-based compensation, amortization of purchased intangible assets and acquisition-related charges, net of taxes, which is a non-GAAP financial measure under Section 101 of Regulation G under the Securities Exchange Act of 1934, as amended. This measure consists of GAAP net income excluding, as applicable, stock-based compensation, amortization of purchased intangible assets and acquisition-related charges. This measure of non-GAAP net income is adjusted by the amount of additional taxes or tax benefit that the company would accrue if it used non-GAAP results instead of GAAP results to calculate the company’s tax liability. Stock-based compensation is a non-cash expense that F5 has accounted for since July 1, 2005 in accordance with the fair value recognition provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718 Compensation—Stock Compensation (“FASB ASC Topic 718”). Amortization of intangible assets is a non-cash expense. Investors should note that the use of intangible assets contribute to revenues earned during the periods presented and will contribute to revenues in future periods. Acquisition-related expenses consist of professional services fees incurred in connection with acquisitions.

The reconciliation of the company’s expected GAAP and non-GAAP fourth quarter earnings also excludes an anticipated loss on a facility sublease from net income (non-GAAP). This loss will be incurred during the quarter ending September 30, 2013 in connection with the extension of certain subleases at the company’s corporate headquarters.

Management believes that non-GAAP net income per share provides useful supplemental information to management and investors regarding the performance of the company’s core business operations and facilitates comparisons to the company’s historical operating results. Although F5’s management finds this non-GAAP measure to be useful in evaluating the performance of the core business, management’s reliance on this measure is limited because items excluded from such measures could have a material effect on F5’s earnings and earnings per share calculated in accordance with GAAP. Therefore, F5’s management will use its non-GAAP earnings and earnings per share measures, in conjunction with GAAP earnings and earnings per share measures, to address these limitations when evaluating the performance of the company’s core business. Investors should consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures in accordance with GAAP.

F5 believes that presenting its non-GAAP measure of earnings and earnings per share provides investors with an additional tool for evaluating the performance of the company’s core business and which management uses in its own evaluation of the company’s performance. Investors are encouraged to look at GAAP results as the best measure of financial performance. However, while the GAAP results are more complete, the company provides investors this supplemental measure since, with reconciliation to GAAP, it may provide additional insight into the company’s operational performance and financial results.

For reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure, please see the section in our Condensed Consolidated Statement of Operations entitled “GAAP to Non-GAAP Reconciliation.”

F5 Networks, Inc.
Consolidated Balance Sheets
(unaudited, in thousands)
June 30, September 30,
2013 2012
Assets
Current assets
Cash and cash equivalents $ 198,280 $ 211,181
Short-term investments 353,045 320,970
Accounts receivable, net of allowances of $3,094 and $3,254 205,138 185,172
Inventories 18,260 17,410
Deferred tax assets 10,617 10,362
Other current assets 48,969 30,986
Total current assets 834,309 776,081
Property and equipment, net 63,720 59,604
Long-term investments 714,331 662,803
Deferred tax assets 33,085 35,478
Goodwill 447,799 348,239
Other assets, net 54,559 28,996
Total assets $ 2,147,803 $ 1,911,201
Liabilities and Shareholders’ Equity
Current liabilities
Accounts payable $ 28,691 $ 27,026
Accrued liabilities 89,780 86,409
Deferred revenue 411,477 352,594
Total current liabilities 529,948 466,029
Other long-term liabilities 21,391 21,078
Deferred revenue, long-term 108,278 94,694
Total long-term liabilities 129,669 115,772
Commitments and contingencies
Shareholders’ equity
Preferred stock, no par value; 10,000 shares authorized, no shares outstanding
Common stock, no par value; 200,000 shares authorized, 78,305 and 78,715 shares issued and outstanding 290,143 326,922
Accumulated other comprehensive loss (9,347 ) (3,829 )
Retained earnings 1,207,390 1,006,307
Total shareholders’ equity 1,488,186 1,329,400
Total liabilities and shareholders’ equity $ 2,147,803 $ 1,911,201
F5 Networks, Inc.
Consolidated Statements of Operations
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
June 30, June 30,
2013 2012 2013 2012
Net revenues
Products $ 196,746 $ 207,118 $ 586,565 $ 608,837
Services 173,556 145,516 499,420 405,851
Total 370,302 352,634 1,085,985 1,014,688
Cost of net revenues (1)(2)
Products 32,350 34,482 93,915 101,350
Services 32,567 25,805 92,189 72,137
Total 64,917 60,287 186,104 173,487
Gross Profit 305,385 292,347 899,881 841,201
Operating expenses (1)(2)(3)
Sales and marketing 121,906 112,064 363,205 329,297
Research and development 54,075 46,985 155,150 129,675
General and administrative 25,327 23,298 75,889 67,760
Total 201,308 182,347 594,244 526,732
Income from operations 104,077 110,000 305,637 314,469
Other income, net 2,874 1,713 6,542 5,002
Income before income taxes 106,951 111,713 312,179 319,471
Provision for income taxes 38,773 39,377 111,096 112,002
Net Income $ 68,178 $ 72,336 $ 201,083 $ 207,469
Net income per share – basic $ 0.87 $ 0.91 $ 2.56 $ 2.62
Weighted average shares – basic 78,516 79,135 78,636 79,188
Net income per share – diluted $ 0.86 $ 0.91 $ 2.54 $ 2.60
Weighted average shares – diluted 78,864 79,655 79,207 79,834
Non-GAAP Financial Measures
Net income as reported $ 68,178 $ 72,336 $ 201,083 $ 207,469
Stock-based compensation expense (4) 27,861 23,537 82,181 69,005
Amortization of purchased intangible assets (5) 1,032 1,894 3,098 3,233
Acquisition-related charges (5) 750
Tax effects related to above items (8,650 ) (7,191 ) (22,576 ) (20,530 )
Net income excluding stock-based compensation, amortization of purchased intangible assets and acquisition-related charges (non-GAAP) – diluted $ 88,421 $ 90,576 $ 263,786 $ 259,927
Net income per share excluding stock-based compensation, amortization of purchased intangible assets and acquisition-related charges (non-GAAP) – diluted $ 1.12 $ 1.14 $ 3.33 $ 3.26
Weighted average shares – diluted 78,864 79,655 79,207 79,834
(1) Includes stock-based compensation as follows:
Cost of net revenues $ 2,966 $ 2,706 $ 8,860 $ 7,828
Sales and marketing 10,259 8,537 31,533 26,945
Research and development 8,966 7,504 25,030 19,840
General and administrative 5,670 4,790 16,758 14,392
$ 27,861 $ 23,537 $ 82,181 $ 69,005
(2) Includes amortization of purchased intangible assets as follows:
Cost of net revenues $ 957 $ 1,704 $ 2,873 $ 2,903
Sales and marketing 75 190 225 330
$ 1,032 $ 1,894 $ 3,098 $ 3,233
(3) Includes acquisition-related charges as follows:
General and administrative $ $ $ $ 750
$ $ $ $ 750
(4) Stock-based compensation is accounted for in accordance with the fair value recognition provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 718, Compensation – Stock Compensation (“FASB ASC Topic 718”)
(5) Beginning with the second quarter of fiscal 2012, the company will exclude amortization of purchased intangible assets and acquisition-related charges in addition to stock-based compensation expense as a non-GAAP financial measure
F5 Networks, Inc.
Consolidated Statements of Cash Flows
(unaudited, in thousands)
Nine Months Ended
June 30,
2013 2012
Operating activities
Net income $ 201,083 $ 207,469
Adjustments to reconcile net income to net cash provided by operating activities:
Realized (gain) loss on disposition of assets and investments (190 ) 552
Stock-based compensation 82,181 69,005
Provisions for doubtful accounts and sales returns 584 1,061
Depreciation and amortization 29,705 24,987
Deferred income taxes (3,601 ) (1,057 )
Changes in operating assets and liabilities, net of amounts acquired:
Accounts receivable (20,550 ) (28,229 )
Inventories (850 ) 111
Other current assets (18,069 ) (13,852 )
Other assets 1,517 (244 )
Accounts payable and accrued liabilities 7,420 (3,089 )
Deferred revenue 72,468 90,168
Net cash provided by operating activities 351,698 346,882
Investing activities
Purchases of investments (744,557 ) (780,493 )
Maturities of investments 509,381 584,085
Sales of investments 138,171 76,444
Increase in restricted cash (713 ) (30 )
Acquisition of intangible assets (250 )
Acquisition of businesses, net of cash acquired (124,918 ) (128,335 )
Purchases of property and equipment (21,434 ) (18,544 )
Net cash used in investing activities (244,070 ) (267,123 )
Financing activities
Excess tax benefit from stock-based compensation 3,656 9,426
Proceeds from the exercise of stock options and
purchases of stock under employee stock purchase plan 29,405 24,942
Repurchase of common stock (150,000 ) (134,776 )
Net cash used in financing activities (116,939 ) (100,408 )
Net decrease in cash and cash equivalents (9,311 ) (20,649 )
Effect of exchange rate changes on cash and cash equivalents (3,590 ) (528 )
Cash and cash equivalents, beginning of period 211,181 216,784
Cash and cash equivalents, end of period $ 198,280 $ 195,607
Wednesday, July 24th, 2013 Uncategorized Comments Off on (FFIV) Announces Third Quarter 2013 Results

(INO) Potent hTERT DNA Cancer Vaccine Shows Potential

Mice and monkey study demonstrates robust and broad immune responses; T-cells 18-fold greater than next best peer technology induce tumor-killing function and increase rate of survival Results published in peer-reviewed Cancer Immunology Research

BLUE BELL, Pa., July 24, 2013 /PRNewswire/ — Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that in a preclinical study with two animal models, Inovio’s hTERT (human telomerase reverse transcriptase) DNA cancer vaccine administered with Inovio’s CELLECTRA® adaptive electroporation delivery technology generated robust and broad immune responses, broke the immune system’s tolerance to its self-antigens, induced T-cells with a tumor-killing function, and increased the rate of survival. Because high levels of hTERT expression are found in 85% of human cancers, regardless of type, Inovio’s cancer candidate holds the potential to perform as a “universal” cancer therapeutic based on these early but unprecedented results. Following this strong preclinical data, Inovio plans to advance its synthetic hTERT cancer vaccine, INO-1400, into clinical trials in 2014.

These results appear in the American Association for Cancer Research journal, Cancer Immunology Research, in a paper entitled: “Highly optimized DNA vaccine targeting human telomerase reverse transcriptase stimulates potent antitumor immunity,” authored by Inovio researchers and collaborators.

Dr. J. Joseph Kim, Inovio’s president and CEO, said: “Inovio has demonstrated in multiple published human studies that our synthetically optimized DNA vaccines delivered with our CELLECTRA delivery system generate best-in-class T-cell immune responses. Here we show that in monkeys our hTERT DNA cancer vaccine generated T-cell immune responses more than 18-fold higher than the previous best results of a peer’s hTERT therapeutic vaccine, which was also a DNA vaccine delivered with electroporation. We are particularly enthusiastic about our vaccine’s potential use as a “universal” cancer therapeutic, given that hTERT is present in the vast majority of cancer types yet rare in normal cells. We plan to develop INO-1400 to treat breast and lung cancers and then expand to other cancer types. This hTERT therapy adds to a growing Inovio oncology franchise spearheaded by our phase II candidate, VGX-3100 for treating HPV-related pre-cancers and cancers, as well as our near clinical INO-5150 to treat prostate cancer.”

Data from both murine and human systems over the past 10 years have demonstrated that TERT-specific cytotoxic T-lymphocytes (CTLs) can recognize and kill TERT-expressing tumor cells in multiple types of cancers. In fact, previous research has shown that breast cancer patients who mounted an hTERT-specific CTL response exhibited significantly longer rates of survival. However, the immune system’s tolerance of cancer cells and their associated antigens produced in the body, which exists to prevent autoimmune diseases, often restricts the immune system’s antitumor response. A major challenge for cancer vaccine development has been to develop approaches to break this tolerance in tumor-bearing hosts. Recent advances in our understanding of antigen presentation and tolerance have led Inovio to create this synthetic DNA vaccine targeting the hTERT antigen.

Inovio constructed a highly optimized synthetic DNA vaccine with multiple proprietary features. Using its novel consensus design approach, two differentiating mutations were incorporated in the vaccine sequence to assist T-cells to more readily recognize self-made hTERT antigens and kill the cancer cells to which these antigens are attached (i.e. break tolerance). In addition, Inovio’s use of a full length antigen DNA sequence encompasses multiple epitopes (parts of an antigen that are recognized by the immune system), potentially helping the immune system by providing multiple opportunities to overcome a tumor’s ability to evade recognition by T-cells.

In the study, Inovio researchers confirmed that vaccination with Inovio’s DNA vaccine delivered by adaptive electroporation induced hTERT-specific cellular immune responses with significantly greater T-cell magnitude compared to prior non-Inovio studies. Over four vaccinations there was a significant dose response, showing the value of multiple vaccinations to increase the immune response and highlighting the limitation of alternative technologies that are not amenable to multiple vaccinations such as viral vectors. Vaccination elicited multiple epitopes not only in mice, but also in monkeys, indicating a broad vaccine-induced immune response.

Study results showed that mice vaccinated with Inovio’s DNA cancer vaccine and then challenged with a cancerous tumor experienced delayed tumor growth and longer overall survival compared with non-vaccinated mice. Mice first challenged with a tumor and then treated with the hTERT DNA vaccine displayed killing activity of the targeted cancer cells expressing the hTERT antigen, with no killing of normal cells that did not express the hTERT antigen. The treated mice experienced significantly smaller tumors and also longer overall survival. Vaccinated animal results were compared to a control group of animals that did not receive Inovio’s DNA cancer vaccine.

In monkeys, whose TERT is 96% similar to human TERT and therefore a highly relevant model for immunotherapeutic vaccine development, the hTERT DNA vaccine elicited strong and broad TERT-specific immune responses and demonstrated the potential to eliminate tumor cells.

Overall, in these studies researchers observed that administration of a synthetic highly optimized hTERT DNA vaccine delivered with electroporation was capable of breaking immune tolerance, and eliciting robust and diverse antigen-specific CTLs, which are responsible for clearing cancerous cells, as well as a potent antitumor response. A favorable safety profile emerged from this study, showing that the vaccine-induced CTLs appeared not to be associated with any major toxicities or organ damage.

The expression of hTERT is thought to correlate with tumor survival and hTERT is associated with 85% of human tumors. Furthermore, there is growing recognition that it may be necessary to target stem cells that produce cancerous cells and recent studies have suggested that cancer stem or stem-like cells also express hTERT. These factors highlight the importance of an effective hTERT-targeting vaccine/immunotherapy and point to the potential benefit of Inovio’s novel cancer vaccine.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today’s cancers and challenging infectious diseases. Its synthetic consensus design approach is intended to help the immune system identify and fight cancer cells or multiple unmatched strains of a mutating virus. These proprietary synthetic vaccines, in combination with Inovio’s electroporation delivery, have in humans generated best-in-class immune responses with a favorable safety profile. Inovio’s lead vaccine, a therapeutic against HPV-caused diseases, is in phase II. Other phase I and preclinical programs focus on HIV, influenza, malaria and hepatitis C virus. Partners and collaborators include the University of Pennsylvania, Merck, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company’s technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2012, our Form 10-Q for the quarter ended March 31, 2013, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media:     Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com

Wednesday, July 24th, 2013 Uncategorized Comments Off on (INO) Potent hTERT DNA Cancer Vaccine Shows Potential

(FB) Facebook Reports Second Quarter 2013 Results

MENLO PARK, Calif., July 24, 2013 /PRNewswire/ — Facebook, Inc. (NASDAQ: FB) today reported financial results for the second quarter, which ended June 30, 2013.

“We’ve made good progress growing our community, deepening engagement and delivering strong financial results, especially on mobile,” said Mark Zuckerberg, Facebook founder and CEO. “The work we’ve done to make mobile the best Facebook experience is showing good results and provides us with a solid foundation for the future.”

Second Quarter 2013 Financial Summary

In millions, except percentages and per share amounts Q2’12 Q2’13 YTD’12 YTD’13
Revenue $ 1,184 $ 1,813 $ 2,242 $ 3,271
Income (Loss) from Operations
GAAP $ (743) $ 562 $ (362) $ 935
Non-GAAP $ 515 $ 794 $ 1,000 $ 1,357
Operating Margin
GAAP (63%) 31% (16%) 29%
Non-GAAP 43% 44% 45% 41%
Net Income (Loss)
GAAP $ (157) $ 333 $ 48 $ 552
Non-GAAP $ 295 $ 488 $ 582 $ 800
Diluted Earnings (Loss) per Share (EPS)
GAAP $ (0.08) $ 0.13 $ 0.02 $ 0.22
Non-GAAP $ 0.12 $ 0.19 $ 0.24 $ 0.32

Second Quarter 2013 Operational Highlights

 

  • Daily active users (DAUs) were 699 million on average for June 2013, an increase of 27% year-over-year.
  • Monthly active users (MAUs) were 1.15 billion as of June 30, 2013, an increase of 21% year-over-year.
  • Mobile MAUs were 819 million as of June 30, 2013, an increase of 51% year-over-year.  Mobile DAUs were 469 million on average for June 2013.

Recent Business Highlights

 

  • Surpassed 1 million active advertisers on Facebook, driven by significant growth in local businesses.
  • Introduced video for Instagram and saw 5 million videos uploaded in the first 24 hours.
  • Facebook for Every Phone has now passed 100 million monthly active users.  In just two years, Facebook for Every Phone has successfully put Facebook into the hands of millions of people around the world with limited access to the Internet, giving them the power to connect and share.
  • Launched products including Verified Pages, hashtags and embedded posts to help people on Facebook connect with their friends about what’s taking place all over the world.
  • Announced that there have now been over 100,000 apps built on Parse, a cloud-based platform that provides scalable cross-platform services and tools for developers to enable them to build apps that span mobile platforms and devices.
  • Facebook’s data center in Lulea, Sweden, began serving live user traffic around the world using Facebook’s Open Compute Project designs and renewable energy.

Second Quarter 2013 Financial Highlights

 

Revenue – Revenue for the second quarter of 2013 totaled $1.81 billion, an increase of 53%, compared with $1.18 billion in the second quarter of 2012.

  • Revenue from advertising was $1.60 billion, representing 88% of total revenue and a 61% increase from the same quarter last year.
  • Mobile advertising revenue represented approximately 41% of advertising revenue for the second quarter of 2013.
  • Payments and other fees revenue was $214 million for the second quarter of 2013, an increase of 11% from the same quarter last year.

Costs and expenses – GAAP costs and expenses for the second quarter of 2013 were $1.25 billion, a decrease of 35% from the second quarter of 2012, as costs in the second quarter of 2012 were materially impacted by the share-based compensation expense resulting from our IPO.  Excluding share-based compensation and related payroll tax expenses, non-GAAP costs and expenses were $1.02 billion in the second quarter, up 52% compared to $669 million for the second quarter of 2012.

Income (loss) from operations – For the second quarter of 2013, GAAP income from operations was $562 million, compared to a GAAP loss from operations of $743 million in the second quarter of 2012. Excluding share-based compensation and related payroll tax expenses, non-GAAP income from operations for the second quarter was $794 million, up 54% compared to $515 million for the second quarter of 2012.

Operating margin – GAAP operating margin was 31% for the second quarter of 2013, compared to negative 63% in the second quarter of 2012. Excluding share-based compensation and related payroll tax expenses, non-GAAP operating margin was 44% for the second quarter of 2013, compared to 43% for the second quarter of 2012.

 

Provision for income taxes – GAAP income tax expense for the second quarter of 2013 was $212 million, representing a 39% effective tax rate. Excluding share-based compensation and related payroll tax expenses, the non-GAAP effective tax rate would have been approximately 37%.

Net income (loss) and EPS For the second quarter of 2013, GAAP net income was $333 million, compared to a net loss of $157 million for the second quarter of 2012. Excluding share-based compensation and related payroll tax expenses and income tax adjustments, non-GAAP net income for the second quarter of 2013 was $488 million, up 65% compared to $295 million for the second quarter of 2012.  GAAP diluted EPS was $0.13 in the second quarter of 2013, compared to a loss per share of $0.08 in the second quarter of 2012.  Excluding share-based compensation and related payroll tax expenses and income tax adjustments, non-GAAP diluted EPS for the second quarter of 2013 was $0.19, up 58% compared to $0.12 in the second quarter of 2012.

Capital expenditures – Capital expenditures for the second quarter of 2013 were $268 million, a 35% decrease from the second quarter of 2012.

Cash and marketable securities – Cash and marketable securities were $10.3 billion at the end of the second quarter of 2013.

 

 

Webcast and Conference Call Information

Facebook will host a conference call to discuss the results at 2 p.m. PT / 5 p.m. ET today. The live webcast can be accessed at the Facebook Investor Relations website at investor.fb.com, along with the company’s earnings press release, financial tables and slide presentation.  Facebook uses the investor.fb.com website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Following the call, a replay will be available at the same website. A telephonic replay will be available for one week following the conference call at + 1 (404) 537-3406 or + 1 (855) 859-2056, conference ID 99420501.

 

 

About Facebook

 

Founded in 2004, Facebook’s mission is to give people the power to share and make the world more open and connected. People use Facebook to stay connected with friends and family, to discover what’s going on in the world, and to share and express what matters to them.

Contacts

 

Investors:
Deborah Crawford
investor@fb.com / investor.fb.com

Press:
Ashley Zandy
press@fb.com / newsroom.fb.com

Forward Looking Statements

This press release contains forward-looking statements regarding our future business expectations, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors including: our ability to retain or increase users and engagement levels, particularly mobile engagement; our ability to monetize our mobile products; risks associated with new product development and introduction; our ability to expand the Facebook Platform; competition; privacy concerns; security breaches; and our ability to manage growth and geographically-dispersed operations. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the SEC on May 2, 2013, which is available on our Investor Relations website at investor.fb.com and on the SEC website at www.sec.gov. Additional information will also be set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2013. In addition, please note that the date of this press release is July 24, 2013, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. We undertake no obligation to update these statements as a result of new information or future events.

Non-GAAP Financial Measures

To supplement our consolidated financial statements, which are prepared and presented in accordance with GAAP, we use the following non-GAAP financial measures: total revenue and advertising revenue excluding foreign exchange effect, non-GAAP costs and expenses, non-GAAP income from operations; non-GAAP net income; non-GAAP diluted shares; non-GAAP diluted earnings per share; non-GAAP operating margin; non-GAAP effective tax rate; and free cash flow. The presentation of these financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. Investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. In particular, many of the adjustments to our GAAP financial measures reflect the exclusion of items, specifically share-based compensation expense and payroll tax related to share-based compensation expense and the related income tax effects, that are recurring and will be reflected in our financial results for the foreseeable future. In addition, these measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes. We compensate for these limitations by providing specific information regarding the GAAP amounts excluded from these non-GAAP financial measures.

We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating our business.

We exclude the following items from one or more of our non-GAAP financial measures:

Share-based compensation expense. We exclude share-based compensation expense because we believe that the non-GAAP financial measures excluding this item provide meaningful supplemental information regarding operational performance. In particular, because of varying available valuation methodologies, subjective assumptions and the variety of award types that companies can use under FASB ASC Topic 718, we believe that providing non-GAAP financial measures that exclude this expense allow investors the ability to make more meaningful comparisons between our operating results and those of other companies. Accordingly, we believe that excluding this expense provides investors and management with greater visibility to the underlying performance of our business operations, facilitates comparison of our results with other periods, and may also facilitate comparison with the results of other companies in our industry.

Payroll tax expense related to share-based compensation. We exclude payroll tax expense related to share-based compensation expense because, without excluding these tax expenses, investors would not see the full effect that excluding share-based compensation expense had on our operating results. These expenses are tied to the exercise or vesting of underlying equity awards and the price of our common stock at the time of vesting or exercise, which factors may vary from period to period independent of the operating performance of our business. Similar to share-based compensation expense, we believe that excluding this payroll tax expense provides investors and management with greater visibility to the underlying performance of our business operations and facilitates comparison with other periods as well as the results of other companies.

Income tax effect of share-based compensation and related payroll tax expenses. We believe excluding the income tax effect of non-GAAP adjustments assists investors and management in understanding the tax provision related to those adjustments and provides useful supplemental information regarding the underlying performance of our business operations.

Assumed preferred stock conversion. As a result of our IPO in May 2012, all outstanding shares of preferred stock were automatically converted into shares of Class B common stock. Consequently, non-GAAP diluted shares and earnings per share for the three and six months ended June 30, 2012 have been calculated assuming this conversion for periods prior to the IPO, which we believe facilitates comparison between periods.

Dilutive equity awards excluded from GAAP. In our calculation of non-GAAP weighted average shares used to compute earnings per share attributable to Class A and Class B common stockholders for the three months ended June 30, 2012, we give effect to antidilutive RSUs and stock options that are excluded from GAAP weighted average shares due to our reporting of a net loss.  We also include the effect of unvested RSUs in periods prior to the IPO in such calculation for the three and six months ended June 30, 2012, the number of which is substantial due to the terms of RSUs granted prior to 2011. We believe including these awards facilitates comparison between periods.

Foreign exchange effect on revenue. We translate revenue for the three and six months ended June 30, 2013 using prior year exchange rates, which we believe is a useful metric that facilitates comparison to our historical performance.

Purchases of property and equipment; Property and equipment acquired under capital leases. We subtract both purchases of property and equipment and property and equipment acquired under capital leases in our calculation of free cash flow because we believe that these two items collectively represent the amount of property and equipment we need to procure to support our business, regardless of whether we finance such property or equipment with a capital lease. We believe that this methodology can provide useful supplemental information to help investors better understand underlying trends in our business.

For more information on our non-GAAP financial measures and a reconciliation of such measures to the nearest GAAP measure, please see the “Reconciliation of Non-GAAP Results to Nearest GAAP Measures” table in this press release.

 

 

FACEBOOK, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In millions, except for per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2012 2013 2012 2013
Revenue $ 1,184 $ 1,813 $ 2,242 $ 3,271
Costs and expenses:
Cost of revenue 367 465 644 878
Research and development 705 344 858 637
Marketing and sales 392 269 535 472
General and administrative 463 173 567 349
Total costs and expenses 1,927 1,251 2,604 2,336
Income (loss) from operations (743) 562 (362) 935
Interest and other (expense) income, net:
Interest expense (10) (14) (24) (29)
Other (expense) income, net (12) (3) 3 (8)
Income (loss) before provision for income taxes (765) 545 (383) 898
(Provision for) benefit from income taxes 608 (212) 431 (346)
Net income (loss) $ (157) $ 333 $ 48 $ 552
Less: Net income attributable to participating securities 2 21 3
Net income (loss) attributable to Class A and Class B common stockholders $ (157) $ 331 $ 27 $ 549
Earnings (loss) per share attributable to Class A and Class B
common stockholders:
Basic $ (0.08) $ 0.14 $ 0.02 $ 0.23
Diluted $ (0.08) $ 0.13 $ 0.02 $ 0.22
Weighted-average shares used to compute earnings (loss) per share
attributable to Class A and Class B common stockholders:
Basic 1,879 2,407 1,613 2,397
Diluted 1,879 2,502 1,792 2,499
Share-based compensation expense included in costs and expenses:
Cost of revenue $ 66 $ 11 $ 71 $ 19
Research and development 545 151 605 268
Marketing and sales 232 33 251 57
General and administrative 263 29 282 50
Total share-based compensation expense $ 1,106 $ 224 $ 1,209 $ 394
Payroll tax expenses related to share-based compensation included in costs and expenses:
Cost of revenue $ 6 $ – $ 6 $ 1
Research and development 48 7 49 18
Marketing and sales 25 1 25 5
General and administrative 73 73 4
Total payroll tax expenses related to share-based compensation $ 152 $ 8 $ 153 $ 28

 

FACEBOOK, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions)
(Unaudited)
December 31, June 30,
2012 2013
Assets
Current assets:
Cash and cash equivalents $ 2,384 $ 3,001
Marketable securities 7,242 7,251
Accounts receivable 719 775
Income tax refundable 451 7
Prepaid expenses and other current assets 471 387
Total current assets 11,267 11,421
Property and equipment, net 2,391 2,577
Goodwill and intangible assets, net 1,388 1,631
Other assets 57 95
Total assets $ 15,103 $ 15,724
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 65 $ 55
Platform partners payable 169 172
Accrued expenses and other current liabilities 423 505
Deferred revenue and deposits 30 32
Current portion of capital lease obligations 365 316
Total current liabilities 1,052 1,080
Capital lease obligations, less current portion 491 351
Long-term debt 1,500 1,500
Other liabilities 305 444
Total liabilities 3,348 3,375
Stockholders’ equity
Common stock and additional paid-in capital 10,094 10,167
Accumulated other comprehensive income (loss) 2 (29)
Retained earnings 1,659 2,211
Total stockholders’ equity 11,755 12,349
Total liabilities and stockholders’ equity $ 15,103 $ 15,724

 

 

 

FACEBOOK, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2012 2013 2012 2013
Cash flows from operating activities
Net income (loss) $ (157) $ 333 $ 48 $ 552
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation and amortization 139 230 249 463
Lease abandonment expense 3 57 3 65
Loss on disposal or write-off of equipment 3 11 4 20
Share-based compensation 1,106 224 1,209 394
Deferred income taxes (350) 26 (374) 19
Tax benefit from share-based award activity 327 89 381 148
Excess tax benefit from share-based award activity (327) (93) (381) (155)
Changes in assets and liabilities:
Accounts receivable (105) (116) (40) (62)
Income tax refundable (567) 419 (567) 444
Prepaid expenses and other current assets 26 10 (7) (16)
Other assets (3) (8) (9) (44)
Accounts payable (5) 1 (8) 2
Platform partners payable (22) (18) (15) 3
Accrued expenses and other current liabilities 184 42 186 9
Deferred revenue and deposits (8) 2 (5) 2
Other liabilities (4) 113 7 197
Net cash provided by operating activities 240 1,322 681 2,041
Cash flows from investing activities
Purchases of property and equipment (413) (268) (866) (595)
Purchases of marketable securities (6,081) (1,952) (6,957) (3,460)
Sales of marketable securities 59 576 128 1,275
Maturities of marketable securities 539 1,271 1,106 2,174
Investments in non-marketable equity securities (2) (1) (3) (1)
Acquisitions of businesses, net of cash acquired, and purchases of intangible assets (550) (122) (575) (221)
Changes in restricted cash and deposits (2) (2) (3) 4
Net cash used in investing activities (6,450) (498) (7,170) (824)
Cash flows from financing activities
Net proceeds from issuance of common stock 6,761 6,761
Taxes paid related to net share settlement of equity awards (153) (558)
Proceeds from exercise of stock options 4 2 9 10
Proceeds from sale and lease-back transactions 20 82
Principal payments on capital lease obligations (72) (91) (143) (200)
Excess tax benefit from share-based award activity 327 93 381 155
Net cash provided by (used in) financing activities 7,040 (149) 7,090 (593)
Effect of exchange rate changes on cash and cash equivalents (14) 1 (15) (7)
Net increase in cash and cash equivalents 816 676 586 617
Cash and cash equivalents at beginning of period 1,282 2,325 1,512 2,384
Cash and cash equivalents at end of period $ 2,098 $ 3,001 $ 2,098 $ 3,001
Supplemental cash flow data
Cash paid during the period for:
Interest $ 10 $ 14 $ 19 $ 26
Income taxes $ 8 $ 9 $ 182 $ 18
Cash received during the period for:
Income taxes $ – $ 419 $ – $ 419
Non-cash investing and financing activities:
Net change in accounts payable and accrued expenses and other current liabilities related to property and equipment additions $ (169) $ (52) $ (59) $ (5)
Property and equipment acquired under capital leases $ 52 $ – $ 90 $ 11
Fair value of shares issued related to acquisitions of businesses and other assets $ 18 $ 44 $ 25 $ 77

 

 

Reconciliation of Non-GAAP Results to Nearest GAAP Measures
(In millions, except for number of shares)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2012 2013 2012 2013
GAAP revenue $ 1,184 $ 1,813 $ 2,242 $ 3,271
Foreign exchange effect on 2013 revenue using 2012 rates 13 17
Revenue excluding foreign exchange effect $ 1,826 $ 3,288
GAAP revenue year-over-year change % 53% 46%
Revenue excluding foreign exchange effect year-over-year change % 54% 47%
GAAP advertising revenue $ 992 $ 1,599 $ 1,864 $ 2,844
Foreign exchange effect on 2013 advertising revenue using 2012 rates 13 16
Advertising revenue excluding foreign exchange effect $ 1,612 $ 2,860
GAAP advertising revenue year-over-year change % 61% 53%
Advertising revenue excluding foreign exchange effect year-over-year change % 63% 53%
GAAP costs and expenses $ 1,927 $ 1,251 $ 2,604 $ 2,336
Share-based compensation expense (1,106) (224) (1,209) (394)
Payroll tax expenses related to share-based compensation (152) (8) (153) (28)
Non-GAAP costs and expenses $ 669 $ 1,019 $ 1,242 $ 1,914
GAAP income (loss) from operations $ (743) $ 562 $ (362) $ 935
Share-based compensation expense 1,106 224 1,209 394
Payroll tax expenses related to share-based compensation 152 8 153 28
Non-GAAP income from operations $ 515 $ 794 $ 1,000 $ 1,357
GAAP net income (loss) $ (157) $ 333 $ 48 $ 552
Share-based compensation expense 1,106 224 1,209 394
Payroll tax expenses related to share-based compensation 152 8 153 28
Income tax adjustments (806) (77) (828) (174)
Non-GAAP net income $ 295 $ 488 $ 582 $ 800
GAAP diluted shares 1,879 2,502 1,792 2,499
Assumed preferred stock conversion1 273 409
Dilutive securities excluded due to net loss 177
Dilutive equity awards excluded from GAAP1 122 185
Non-GAAP diluted shares 2,451 2,502 2,386 2,499
GAAP diluted earnings (loss) per share $ (0.08) $ 0.13 $ 0.02 $ 0.22
Net income attributable to participating securities 0.01
Non-GAAP adjustments to net (loss) income 0.24 0.06 0.29 0.10
Non-GAAP adjustments to diluted shares (0.04) (0.08)
Non-GAAP diluted earnings per share $ 0.12 $ 0.19 $ 0.24 $ 0.32
GAAP operating margin (63%) 31% (16%) 29%
Share-based compensation expense 93% 12% 54% 12%
Payroll tax expenses related to share-based compensation 13% -% 7% 1%
Non-GAAP operating margin 43% 44% 45% 41%
GAAP income (loss) before (provision for) benefit from income taxes $ (765) $ 545 $ (383) $ 898
GAAP (provision for) benefit from income taxes 608 (212) 431 (346)
GAAP effective tax rate 79% 39% 113% 39%
GAAP income (loss) before (provision for) benefit from income taxes $ (765) $ 545 $ (383) $ 898
Share-based compensation and related payroll tax expenses 1,258 232 1,362 422
Non-GAAP income before provision for income taxes $ 493 $ 777 $ 979 $ 1,320
Non-GAAP provision for income taxes 198 289 397 520
Non-GAAP effective tax rate 40% 37% 41% 39%
Net cash provided by operating activities $ 240 $ 1,322 $ 681 $ 2,041
Purchases of property and equipment (413) (268) (866) (595)
Property and equipment acquired under capital leases (52) (90) (11)
Free cash flow $ (225) $ 1,054 $ (275) $ 1,435
1 Gives effect to assumed preferred stock conversion and other dilutive equity awards prior to our IPO for comparability
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