Archive for July, 2010
Orient Paper (ONP) Announces Preliminary Second Quarter 2010 Financial Results
Orient Paper Announces Preliminary Second Quarter 2010 Financial Results
BAODING, China, July 29 /PRNewswire-Asia-FirstCall/ — Orient Paper, Inc. (AMEX: ONP) (“Orient Paper” or the “Company”), a leading manufacturer and distributor of diversified paper products in Hebei, China, today announced unaudited preliminary results for the three months ended June 30, 2010. The Company will release full financial results prior to filing its Form 10-Q on or before August 16, 2010 and will hold an earnings conference call to discuss those results.
For the three months ended June 30, 2010, the Company is expecting to report total unaudited revenue increased 70.8%, to approximately $38.3 million from approximately $22.4 million in the same period last year. The Company is also expecting unaudited net income to be approximately $5.0 million, or $0.28 per diluted share, up 102.5% from approximately $2.5 million, or $0.20 per diluted share, for the same period last year.
Mr. Zhenyong Liu, Chairman and Chief Executive Officer, stated, “Our increased second quarter sales were mainly attributable to a combination of factors, including increased average selling prices in our corrugating medium paper and medium-grade offset printing paper products due to the general increase in paper and pulp pricing in the market during the second quarter of 2010, and the increased sales volume of our medium-grade offset printing paper product. In addition, we continued to grow our digital photo paper sales during the second quarter. Our net income growth was attributable to our strong sales growth and our ability to achieve higher gross and operating margins during the quarter. Overall, we are pleased with our preliminary second quarter sales and earnings results and look forward to reporting our full financial results next month.”
About Orient Paper, Inc.
Orient Paper, Inc., through its wholly owned subsidiaries, Shengde Holdings, Inc., controls and operates Baoding Shengde Paper Co., Ltd. (“Baoding Shengde”), and Hebei Baoding Orient Paper Milling Co., Ltd (“HBOP”). Founded in 1996, HBOP is engaged in the production and distribution of products such as corrugating medium paper, offset printing paper, writing paper, and other paper and packaging-related products in China. The Company uses recycled paper as its primary raw material. Baoding Shengde, founded in June 2009 located in Baoding, is engaged in the production and distribution of digital photo paper. As one of the largest paper producers in Hebei Province, China, HBOP is strategically located in Baoding, a city in close proximity to Beijing where the majority of publishing houses are based. Orient Paper is led by an experienced management team committed to diversifying the Company’s product offering and delivering tailored services to its customers. For more information, please visit http://www.orientalpapercorporation.com .
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this announcement are forward-looking statements, including but not limited to, anticipated revenues from the digital photo paper business segment; the actions and initiatives of current and potential competitors; the Company’s ability to introduce new products; the Company’s ability to implement the planned capacity expansion of corrugated medium paper; market acceptance of new products; general economic and business conditions; the ability to attract or retain qualified senior management personnel and research and development staff; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the companies and the industry. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results.
For more information, please contact: CCG Investor Relations Mr. Crocker Coulson, President Phone: +1-646-213-1915 Email: crocker.coulson@ccgir.com Website: http://www.ccgirasia.com Orient Paper, Inc. Winston Yen, Chief Financial Officer Phone: +1-562-818-3817 (Los Angeles) Email: info@orientalpapercorporation.com
SOURCE Orient Paper, Inc.
Central Virginia Bankshares (CVBK) Reports Solid Core Earnings in Second Quarter
POWHATAN, Va., July 30 /PRNewswire-FirstCall/ — Central Virginia Bankshares, Inc. (Nasdaq:CVBK – News) and Central Virginia Bank announce continuing solid “core earnings” in the second quarter 2010. Core earnings for the second quarter were $467.2 thousand, and for the year to date are $1.30 million. Core earnings represent a non-GAAP measure defined as GAAP pre-tax net income excluding loan loss and OREO expense, impairment charges, and securities gains and losses. It indicates that the basic or core earning capacity of the bank is producing positive revenue.
The Company’s financial performance reported for the second quarter 2010 was a net loss of $1.11 million, and after effective dividends of $160.6 thousand on preferred stock, resulting in a net loss available to common shareholders of $1.27 million or $(0.48) per basic and diluted share, compared to the second quarter of 2009’s loss of $96.4 thousand and after effective dividends of $160.6 thousand on preferred stock, a net loss available to common shareholders of $255.9 thousand or $(0.10) per basic and diluted share.
“We continued our efforts to maintain an adequate reserve for potential future loan losses by increasing our reserve by over $2.9 million during the second quarter, which obviously had a negative impact on our earnings. However, we are very pleased that our core earnings as well as our deposit base continue to show strength,” commented Herb Marth, Chief Operating Officer of Central Virginia Bank. He added, “We’re here to serve our customers, and every day we’re making loans and opening new deposit accounts. We fully intend to emerge from this, the most severe recession since the great depression, a stronger, more efficient, and even more customer oriented financial institution.”
At the end of the second quarter, the Bank’s tier 1 risk-based capital ratio and leverage ratio continue to be above the well capitalized minimum levels while the total risk based capital position remains above the minimum adequately capitalized level at quarter end. The Bank has recently completed a follow up regulatory examination and is well on its way towards satisfying many of the regulatory requirements. The company has also filed with the United States Securities and Exchange Commission a preliminary Form S-1 for registration of new common stock.
Chief Operating Officer, Herb Marth added: “We are pleased with our Company’s performance, despite the reported loss for the second quarter, as we believe we are getting closer to having the worst behind us. We continue to experience growth in core deposits. Overall, we feel very positive about our future.”
Jim Napier, Chairman of the Board, added “We have a strong and solid franchise with extremely loyal customers. Our mission continues to be serving the needs of our customers; rewarding our shareholders; developing and supporting our employees; and giving back to the communities where we live and work. Customers of Central Virginia Bank can feel confident maintaining their relationship with the Bank. Our entire team is committed to successfully overcoming the challenges that lie ahead and emerging a stronger organization.”
Additional Financial Discussion
Average loan balances for the Bank declined by $13.7 million to $284.9 million, a decrease of 4.6 percent from the prior year’s comparable quarter. The investment securities portfolio averaged $124.4 million, a decrease of $42.4 million or 25.4 percent from $166.8 million in second quarter 2009. Total assets averaged $459.2 million, having declined by $40.6 million or 8.1 percent from $499.7 million in the prior year.
Total deposits averaged $375.7 million, an increase of $2.3 million from the second quarter 2009. Total borrowings averaged $53.6 million a decrease of $41.3 million or 43.5 percent from the prior year’s second quarter. The decline of $41.3 million in average total borrowings from $95.0 million to $53.6 million at quarter end reflects the Bank management’s strategy of reducing leverage of the balance sheet and improving liquidity by facilitating shrinkage of the investment portfolio.
The fully tax equivalent net interest income in the second quarter 2010 was $3.2 million. The continued low interest rate environment has helped the Bank’s net interest margin in the second quarter 2010, resulting in a net interest margin of 3.06 an increase from the preceding first quarter’s 2.90 percent and from the comparable quarter of 2009’s 2.93 percent. Total interest income for the quarter was $5.4 million while total interest expense was $2.3 million. Interest income of $5.4 million was lower by 17.5 percent from a year earlier due to lower volume of investment securities and the drag from non-performing assets. On the expense side, however, the Bank’s interest expense of $2.3 million also declined by 29.1 percent from the prior year’s second quarter due primarily to lower interest rates on deposits.
Non-interest income of $1.3 million was a decrease of 7.9 percent or $109.86 thousand from the prior year’s second quarter total of $1.4 million. The decrease was due primarily to:
- a decline in the Bank’s realized gains on the sale of securities available for sale,
- lower secondary market mortgage loan fees, and
- lower deposit fees and charges, partially offset by increasing bank card fees.
Total non-interest expense for the second quarter 2010 was $3.67 million a decrease of 15.2 percent or $805 thousand as compared to $4.33 million last year. Second quarter non-interest expense included:
- salaries and benefits totaled $1.51 million in the second quarter, a decrease of $148 thousand.
- loss on devaluation of other real estate owned (“OREO”) of $146 thousand compared to zero last year.
- other than temporary impairment (“OTTI”) charges on the CDO debt securities in our investment portfolio of $11 thousand, a decrease of $1.04 million from last year.
The Bank remains committed to reducing all controllable or discretionary expenses as well as focusing on increasing non-interest income. Reducing growth in expenses will improve current and benefit future periods and is consistent with the goal of improving the efficiency ratio. This is evidenced by the improvement in this measure to 81.67 percent from 88.31 percent in the second quarter of the prior year.
Non-performing assets at the end of the second quarter increased modestly to $32.5 million compared to $31.2 million at the end of the preceding first quarter of 2010 and $15.4 million in the second quarter of the prior year. The directional growth in non-performing assets has declined for the second quarter in a row as the increase from March 31, 2010 was only 4.3 percent.
See chart below for additional financial information.
About Central Virginia Bankshares, Inc.
Central Virginia Bankshares, Inc. is the parent of Central Virginia Bank, a 36 year old $449 million community bank with its headquarters and main office in Powhatan County, and six additional branch offices; two branches in the adjacent County of Cumberland, three branches in western Chesterfield County, and one branch in western Henrico County. Central Virginia Bankshares, Inc. trades under the symbol CVBK (NASDAQ).
Cautionary Statement about Forward-Looking Information
In accordance with the Private Securities Litigation Reform Act of 1995, we caution you that this news release contains forward-looking statements about our future financial performance and business. We make forward-looking statements when we use words such as “believe,” “expect,” “anticipate,” “estimate,” “should,” “may,” “can,” “will,” “outlook,” “project,” “appears” or similar expressions. Forward-looking statements in this news release may include, among others, statements about: (i) future credit quality and expected or estimated future loan losses in our loan portfolios, including our belief that quarterly provision expense and quarterly total credit losses have peaked and are expected to decline; the level and loss content of nonperforming assets and nonaccrual loans; (ii) and the adequacy of the allowance for loan losses; (iii) stabilization of OTTI charges on our investment security portfolio.
Do not unduly rely on forward-looking statements as actual results could differ materially from expectations. Forward-looking statements speak only as of the date made, and we do not undertake to update them to reflect changes or events that occur after that date. Several factors could cause actual results to differ materially from expectations including: current and future economic and market conditions, including the effects of further declines in housing prices and high unemployment rates; our capital requirements and our ability to generate capital internally or raise capital on favorable terms; the terms of capital investments or other financial assistance provided by the U.S. government; financial services reform; recognition of other than-temporary impairment on securities held in our available-for-sale portfolio; the effect of changes in interest rates on our net interest margin; our ability to sell more products to our customers; the effect of the economic recession on the demand for our products and services; changes in our accounting policies or in accounting standards or in how accounting standards are to be applied; mergers and acquisitions; federal and state regulations; reputational damage from negative publicity, fines, penalties and other negative consequences from regulatory violations; the loss of checking and saving account deposits to other investments such as the stock market; and fiscal and monetary policies of the Federal Reserve Board. There is no assurance that our allowance for credit losses will be adequate to cover future credit losses, especially if credit markets, housing prices, and unemployment do not improve. Increases in loan charge-offs or in the allowance for credit losses and related provision expense could materially adversely affect our financial results and condition. For more information about factors that could cause actual results to differ materially from our expectations, refer to our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2009, including the discussions under “Risk Factors” in that report, as filed with the SEC and available on the SEC’s website at www.sec.gov. Any factor described above or in our SEC reports could, by itself or together with one or more other factors, adversely affect our financial results and condition.
Central Virginia Bankshares, Inc. |
Second Quarter (Unaudited) |
Year to Date |
|||
June 30, 2010 |
June 30, 2009 |
June 30, 2010 |
June 30, 2009 |
||
Net Income (Loss) |
(1,108,336) |
(95,356) |
(1,021,257) |
165,780 |
|
Net Income Available to Common Shareholders |
(1,268,923) |
(255,943) |
(1,342,431) |
(103,447) |
|
Interest & Fees on Loans |
4,063,261 |
4,520,693 |
8,242,072 |
8,863,498 |
|
Interest on Investments |
1,343,319 |
2,034,628 |
2,793,942 |
4,151,874 |
|
Interest on Funds Sold |
5,779 |
2,840 |
14,226 |
9,200 |
|
Interest on Deposits |
1,781,915 |
2,575,125 |
3,855,241 |
5,273,059 |
|
Interest on Borrowings |
474,860 |
608,599 |
936,442 |
1,357,681 |
|
Interest Expense |
2,256,775 |
3,183,724 |
4,791,683 |
6,630,740 |
|
Net Interest Income |
3,155,585 |
3,374,438 |
6,258,557 |
6,393,832 |
|
Net Interest Income (FTE) |
3,217,073 |
3,467,541 |
6,393,634 |
6,576,865 |
|
Non Interest Income |
1,272,895 |
1,394,056 |
2,163,983 |
2,342,268 |
|
Loan Loss Provision |
2,904,832 |
550,000 |
3,219,976 |
925,000 |
|
Non Interest Expense |
3,671,943 |
4,330,557 |
7,279,101 |
7,563,643 |
|
Period End Balances: |
|||||
Investment Securities |
103,841,752 |
136,631,020 |
|||
Fed Funds Sold |
13,374,000 |
6,290,000 |
|||
Loans (net of Unearned Discount) |
281,093,546 |
298,927,976 |
|||
Loan Loss Reserve |
(10,308,079) |
(4,005,228) |
|||
Non Interest Bearing Deposits |
39,439,966 |
39,127,191 |
|||
Total Deposits |
368,735,437 |
377,675,412 |
|||
Borrowings |
48,046,514 |
81,308,139 |
|||
Assets |
488,731,255 |
492,992,055 |
|||
Period End Shareholders Equity |
27,808,181 |
30,524,970 |
|||
Average Balances: |
|||||
Average Assets |
459,151,888 |
499,730,644 |
499,730,644 |
504,570,627 |
|
Average Earning Assets |
420,989,823 |
474,054,427 |
474,062,427 |
474,691,403 |
|
Investment Securities |
124,429,900 |
166,828,278 |
127,241,353 |
167,070,266 |
|
Federal Funds Sold |
10,279,253 |
6,880,648 |
12,844,105 |
9,747,254 |
|
Loans Held for Sale |
1,415,621 |
1,784,952 |
1,184,549 |
1,343,366 |
|
Loans (net of Unearned ) |
284,865,049 |
298,570,548 |
287,997,852 |
296,530,517 |
|
Non Interest Bearing Deposits |
39,321,139 |
37,226,889 |
37,620,639 |
40,345,955 |
|
Total Deposits |
375,738,632 |
373,435,141 |
378,697,890 |
371,930,249 |
|
FHLB Overnight Advances |
5,450,549 |
11,725,275 |
7,712,707 |
13,104,972 |
|
FHLB Term Borrowings |
40,000,000 |
41,923,077 |
40,000,000 |
43,453,039 |
|
Fed Funds Purchased & REPO |
3,027,170 |
36,157,070 |
3,949,750 |
36,974,015 |
|
Long term debt, Capital Trust Preferred |
5,155,000 |
5,155,000 |
5,155,000 |
5,155,000 |
|
Average Shareholders’ Equity |
28,618,965 |
27,918,192 |
27,956,243 |
28,654,233 |
|
Average Shares Outstanding – Basic |
2,620,762 |
2,603,188 |
2,619,752 |
2,600,246 |
|
Average Shares Outstanding – Fully Diluted |
2,620,762 |
2,603,188 |
2,691,752 |
2,600,246 |
|
Asset Quality: |
|||||
Charged Off Loans |
3,240,944 |
420,769 |
3,887,621 |
741,294 |
|
Recoveries |
151,073 |
4,342 |
162,116 |
25,064 |
|
Period End: Non -Accrual Loans |
26,163,738 |
7,554,410 |
|||
Loans Past Due 90 Days or More |
355,273 |
3,832,043 |
|||
Other Non Performing Assets |
2,165,000 |
0 |
|||
Other Real Estate |
3,849,566 |
3,928,299 |
|||
Total Non Performing Assets |
32,533,577 |
15,314,752 |
|||
Per Share Data & Ratios: |
|||||
Net Income (loss) Per Share – Basic |
$(0.48) |
$(0.10) |
$(0.51) |
$(0.04) |
|
Net Income (loss) Per Share – Diluted |
$(0.48) |
$(0.10) |
$(0.51) |
$(0.04) |
|
Period End Book Value Per Share |
$10.60 |
$11.70 |
$10.60 |
$11.70 |
|
Return on Average Assets |
-0.97% |
-0.08% |
-0.44% |
0.07% |
|
Return on Average Equity |
-15.53% |
-1.37% |
-7.32% |
1.16% |
|
Efficiency Ratio |
81.78% |
88.31% |
85.06% |
85.67% |
|
Average Loans to Average Deposits |
75.81% |
79.95% |
76.05% |
79.73% |
|
Reserve for Loan Losses / Loans EOP |
3.67% |
1.34% |
|||
Net Interest Margin (FTE) |
3.06% |
2.93% |
2.98% |
2.77% |
Geron (GERN) to Proceed with First Human Clinical Trial of Embryonic Stem Cell-Based Therapy
MENLO PARK, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq:GERN – News) announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the clinical hold placed on Geron’s Investigational New Drug (IND) application has been lifted and the company’s Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.
The FDA notification enables Geron to move forward with the world’s first clinical trial of a human embryonic stem cell (hESC)-based therapy in man. The Phase I multi-center trial is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.
“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged – to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease.”
The clinical hold was placed following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts within the injury site in the spinal cord of animals injected with GRNOPC1 than had previously been noted in numerous foregoing studies. In response to those results, Geron developed new markers and assays as additional release specifications for GRNOPC1. The company completed an additional confirmatory preclinical animal study to test the new markers and assays, and subsequently submitted a request to the FDA for the clinical hold to be lifted.
GRNOPC1, Geron’s lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).
“The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury,” said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. “We know that demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”
The GRNOPC1 Clinical Program
Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury.
Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.
Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.
Other Potential Neurological Indications for GRNOPC1
In addition to spinal cord injury, GRNOPC1 may have therapeutic utility for other central nervous system indications. Geron has established a number of collaborations with academic groups to test GRNOPC1 in selected animal models of human disease for which there is a strong rationale for the approach.
Alzheimer’s Disease: Alzheimer’s disease is a progressive, fatal, degenerative disorder that attacks the neurons in the brain, resulting in loss of memory, cognitive function such as reasoning and language, and behavioral changes. According to the Alzheimer’s Association an estimated five million people in the United States have Alzheimer’s disease. GRNOPC1 is being evaluated in animal models of Alzheimer’s disease in collaboration with Professor Frank M. LaFerla, Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND) at the University of California, Irvine.
Multiple Sclerosis (MS): MS is an autoimmune disease that causes demyelination of nerve axons in the brain and spinal cord often progressing to physical and cognitive disability. There is currently no known cure for the disease. According to the National Multiple Sclerosis Society there are about 400,000 people in the United States with MS. GRNOPC1 is being tested in a non-human primate model of MS in collaboration with Professor Jeffery D. Kocsis of the Departments of Neurology and Neurobiology at Yale University School of Medicine and the Department of Veterans Affairs.
Canavan Disease: Canavan disease is a fatal neurological disorder that belongs to a group of genetic disorders called leukodystrophies, characterized by the abnormal development or degeneration of myelin. Symptoms of Canavan disease present in the first six months of life and death usually occurs at 3 – 10 years of age. GRNOPC1 is being tested in a rodent model of Canavan disease in collaboration with Dr. Paola Leone, Director of the Cell and Gene Therapy Center, at the University of Medicine and Dentistry of New Jersey.
Background on GRNOPC1
Additional information on Geron’s hESC programs and GRNOPC1 is available at Geron’s website www.geron.com.
About Geron
Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials in different cancers. For more information, visit www.geron.com.
This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of Geron’s human embryonic stem cell technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and protection of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron’s periodic reports, including the quarterly report on Form 10-Q for the quarter ended March 31, 2010.
Bel Reports (BELFA) Second Quarter Net Earnings of $4.7 Million Versus a Loss of $1.3 Million
JERSEY CITY, N.J.–(BUSINESS WIRE)–Bel Fuse Inc. (NASDAQ:BELFA – News)(NASDAQ:BELFB – News) today announced preliminary unaudited financial results for the second quarter of 2010, highlighted by a 73% increase in net sales and an increase in net earnings to $4.7 million compared to a net loss of $1.3 million for the second quarter of 2009.
Daniel Bernstein, Bel’s President and CEO, said, “We experienced solid growth in all of our product groups driven by strong demand from high-end telecom, computing and network applications. Robust business conditions currently appear likely to continue for the balance of the year. Substantial gains in gross margins are primarily the result of the improved productivity of our new associates in China. So far this year we have added approximately 2,483 new workers at our China facilities, which has allowed us to shorten our leadtimes.
“Cinch’s well-established lines of connectors and cable products represented 45% of the increase in sales and are a natural addition to Bel’s traditional product menu. And its extensive customer base has opened key aerospace and military markets to Bel for the first time, while creating new opportunities for long-term growth.”
Second Quarter Results
For the three months ended June 30, 2010, net sales increased 73% to $77,732,000 compared to $44,934,000 for the second quarter of 2009. This year’s second quarter net sales included $14,914,000 from Cinch Connectors, which was acquired on January 29, 2010. Excluding the Cinch Connector sales, net sales increased 40% for this year’s second quarter versus prior year, and increased 36% versus the first quarter of 2010.
Net earnings for the second quarter of 2010 were $4,695,000, which was net of severance and plant closure costs of $477,000 ($454,000 after tax). In comparison, the net loss for the second quarter of 2009 was $1,272,000, which included restructuring, severance and unauthorized stock issuance costs of $1,700,000 ($1,160,000 after tax), and an after-tax net gain on sale of investments of $671,000.
Adjusted to exclude severance and plant closure costs, non-GAAP net income for the second quarter of 2010 was $5,171,000. This compares to a non-GAAP net loss for the second quarter of 2009 of $775,000, adjusted to exclude restructuring, severance and unauthorized stock issuance costs and a gain on sale of investments. A reconciliation of non-GAAP to GAAP financial measures is provided in the table attached to this press release.
Net earnings per diluted Class A common share for the second quarter of 2010 were $0.38, compared to a net loss per diluted Class A common share of $0.11 for the second quarter of 2009. Adjusted to exclude severance and plant closure costs, non-GAAP net earnings per diluted Class A common share were $0.42 for this year’s second quarter, compared to a non-GAAP net loss per Class A common share of $0.07 for the second quarter of 2009, adjusted to exclude restructuring, severance and unauthorized stock issuance costs and a gain on sale of investments.
Net earnings per diluted Class B common share were $0.41 for the second quarter of 2010, compared to a net loss per diluted Class B common share of $0.11 for the second quarter of 2009. Adjusted to exclude severance and plant closure costs, non-GAAP net earnings per diluted Class B common share were $0.45 for the second quarter of 2010, compared to a non-GAAP net loss per Class B common share of $0.07 for the second quarter of 2009, adjusted to exclude restructuring, severance and unauthorized stock issuance costs and a gain on sale of investments.
Cost of sales decreased to 79.3% of sales for the second quarter of 2010, compared to 89.4% of sales for the second quarter of 2009.
Income from operations for this year’s second quarter was $5,738,000, including operating income of approximately $1,400,000 at Cinch Connectors. This compares to an operating loss of $2,872,000 for the second quarter of 2009. Adjusted to exclude severance and plant closure costs, non-GAAP income from operations for the second quarter of 2010 increased to $6,250,000, compared to a non-GAAP loss from operations of $1,159,000 for the second quarter of 2009, adjusted to exclude restructuring, severance and unauthorized stock issuance costs.
At June 30, 2010, Bel reported working capital of approximately $143,875,000, including cash, cash equivalents, short-term investments and marketable securities of approximately $75,658,000, a current ratio of 4.7, total long-term obligations of $9,730,000, and stockholders’ equity of $211,746,000. In comparison, at December 31, 2009, Bel reported working capital of approximately $167,800,000, including cash, cash equivalents, short-term investments and marketable securities of approximately $124,233,000, a current ratio of 7.0, total long-term obligations of $9,017,000, and stockholders’ equity of $208,932,000.
First Half Results
For the six months ended June 30, 2010, net sales increased 51% to $133,881,000 compared to $88,805,000 for 2009. Net income for the first six months of 2010 increased to $4,727,000, compared to a net loss of $456,000 for the first six months of 2009.
Net earnings per Class A common share for the first six months of 2010 were $0.38, compared to a net loss per Class A common share of $0.05 for the same period of 2009. Net earnings per Class B common share for the first six months of 2010 were $0.41, compared to a net loss per Class B common share of $0.04 for the first six months of 2009.
Conference Call
Bel has scheduled a conference call at 11:00 a.m. EDT today. To participate in the call, dial (720) 545-0088, conference ID #88718038. A simultaneous webcast is available from the Events and Presentations link of the Investor Info tab at www.belfuse.com. A replay will be available for 20 days at this same Internet address. For a telephone replay, dial (706) 645-9291, conference ID #88718038 after 2:00 p.m. EDT.
About Bel
Bel (www.belfuse.com) and its divisions are primarily engaged in the design, manufacture, and sale of products used in networking, telecommunications, high-speed data transmission, commercial aerospace, military, transportation, and consumer electronics. Products include magnetics (discrete components, power transformers and MagJack® connectors with integrated magnetics), modules (DC-DC converters, integrated analog front-end modules, custom designs), circuit protection (miniature, micro and surface mount fuses) and interconnect devices (micro, circular and filtered D-Sub connectors, passive jacks, plugs and high-speed cable assemblies). The Company operates facilities around the world.
Forward-Looking Statements
Except for historical information contained in this news release, the matters discussed in this press release (including statements regarding the likelihood of robust business conditions continuing in the future, opportunities for growth resulting from the Cinch Connector acquisition and future performance) are forward looking statements that involve risks and uncertainties. Among the factors that could cause actual results to differ materially from such statements are: the market concerns facing our customers, the continuing viability of sectors that rely on our products, the effect of business and economic conditions; capacity and supply constraints or difficulties; product development, commercializing or technological difficulties; the regulatory and trade environment; risks associated with integrating the Cinch Connectors business into the Company’s existing business; risks associated with foreign currencies; uncertainties associated with legal proceedings; the market’s acceptance of the Company’s new products and competitive responses to those new products and the risk factors detailed from time to time in the Company’s SEC reports. In light of the risks and uncertainties, there can be no assurance that any forward-looking statement will in fact prove to be correct. We undertake no obligation to update or revise any forward-looking statements.
BEL FUSE INC. AND SUBSIDIARIES | ||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||
(000s omitted, except for per share data) | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30 | June 30 | |||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Net Sales
|
$
|
77,732
|
$
|
44,934
|
$
|
133,881
|
$
|
88,805
|
||||||
Costs and expenses:
|
||||||||||||||
Cost of sales
|
61,676
|
40,192
|
108,729
|
78,403
|
||||||||||
Selling, general and administrative
|
10,299
|
7,601
|
19,461
|
15,254
|
||||||||||
Restructuring charge
|
—
|
—
|
—
|
413
|
||||||||||
Loss (gain) on sale of property, plant and equipment
|
19
|
13
|
19
|
(4,652
|
)
|
|||||||||
71,994
|
47,806
|
128,209
|
89,418
|
|||||||||||
Income (loss) from operations
|
5,738
|
(2,872
|
)
|
5,672
|
(613
|
)
|
||||||||
Gain on sale of investment
|
—
|
1,081
|
—
|
1,083
|
||||||||||
Interest income and other, net
|
116
|
127
|
238
|
316
|
||||||||||
Earnings (loss) before provision (benefit) for income taxes
|
5,854
|
(1,664
|
)
|
5,910
|
786
|
|||||||||
Income tax provision (benefit)
|
1,159
|
(392
|
)
|
1,183
|
1,242
|
|||||||||
Net earnings (loss)
|
$
|
4,695
|
$
|
(1,272
|
)
|
$
|
4,727
|
$
|
(456
|
)
|
||||
Earnings (loss) per Class A common share basic and diluted
|
$
|
0.38
|
$
|
(0.11
|
)
|
$
|
0.38
|
$
|
(0.05
|
)
|
||||
Weighted average Class A common shares outstanding basic and diluted
|
2,175
|
2,175
|
2,175
|
2,176
|
||||||||||
Earnings (loss) per Class B common share basic and diluted
|
$
|
0.41
|
$
|
(0.11
|
)
|
$
|
0.41
|
$
|
(0.04
|
)
|
||||
Weighted average Class B common shares outstanding basic and diluted
|
9,496
|
9,343
|
9,480
|
9,353
|
CONDENSED CONSOLIDATED BALANCE SHEET DATA
|
||||||||||||||
(000s omitted)
|
||||||||||||||
Jun. 30,
|
Dec. 31,
|
Jun. 30,
|
Dec. 31,
|
|||||||||||
ASSETS
|
2010
|
2009
|
LIABILITIES & EQUITY
|
2010
|
2009
|
|||||||||
(unaudited)
|
(audited)
|
(unaudited)
|
(audited)
|
|||||||||||
Current assets
|
$
|
182,860
|
$
|
195,830
|
Current liabilities
|
$
|
38,985
|
$
|
27,997
|
|||||
Property, plant & equipment, net
|
47,835
|
35,943
|
Noncurrent liabilities
|
9,730
|
9,017
|
|||||||||
Goodwill
|
4,548
|
1,957
|
||||||||||||
Intangibles & other assets
|
25,218
|
12,216
|
Stockholders’ equity
|
211,746
|
208,932
|
|||||||||
Total Assets
|
$
|
260,461
|
$
|
245,946
|
Total Liabilities & Equity
|
$
|
260,461
|
$
|
245,946
|
BEL FUSE INC. AND SUBSIDIARIES | ||||||||||||||||||||||||||||||||
NON-GAAP MEASURES (unaudited) | ||||||||||||||||||||||||||||||||
(000s omitted, except for per share data) | ||||||||||||||||||||||||||||||||
Three Months Ended June 30, 2010 | Six Months Ended June 30, 2010 | |||||||||||||||||||||||||||||||
Incomefrom
Operations |
Net earnings
(2)
|
Net earnings per Class A common
share – diluted(3)
|
Net earnings per Class B common
share – diluted(3)
|
Incomefrom
Operations |
Net earnings
(2)
|
Net earnings per Class A common share – diluted(3)
|
Net earnings per Class B common
share – diluted(3)
|
|||||||||||||||||||||||||
GAAP measures | $ | 5,738 | $ | 4,695 | $ | 0.38 | $ | 0.41 | $ | 5,672 | $ | 4,727 | $ | 0.38 | $ | 0.41 | ||||||||||||||||
Severance costs and plant closure expenses | 477 | 454 | 0.04 | 0.04 | 1,052 | 956 | 0.08 | 0.08 | ||||||||||||||||||||||||
Acquisition-related costs and inventory-related purchase accounting adjustments
|
16 | 10 | 0.00 | 0.00 | 1,094 | 678 | 0.06 | 0.06 | ||||||||||||||||||||||||
Loss on sale of property, plant and equipment | 19 | 12 | 0.00 | 0.00 | 19 | 12 | 0.00 | 0.00 | ||||||||||||||||||||||||
Non-GAAP measures excluding severance and other one-time costs, acquisition-related costs, and inventory-related purchase accounting adjustments(1)
|
$ | 6,250 | $ | 5,171 | $ | 0.42 | $ | 0.45 | $ | 7,837 | $ | 6,373 | $ | 0.51 | $ | 0.55 | ||||||||||||||||
Three Months Ended June 30, 2009 | Six Months Ended June 30, 2009 | |||||||||||||||||||||||||||||||
(Loss)from
Operations |
Net
(Loss)(2) |
Net (Loss) perClass A common
share – diluted(3) |
Net (Loss) perClass B common
share – diluted(3) |
(Loss)from
Operations |
Net
(loss)(2) |
Net (Loss) perClass A common
share – diluted(3) |
Net (Loss) perClass B common
share – diluted(3) |
|||||||||||||||||||||||||
GAAP measures | $ | (2,872 | ) | $ | (1,272 | ) | $ | (0.11 | ) | $ | (0.11 | ) | $ | (613 | ) | $ | (456 | ) | $ | (0.05 | ) | $ | (0.04 | ) | ||||||||
Restructuring, severance, and unauthorized stock issuance costs
|
1,700 | 1,160 | 0.10 | 0.10 | 2,341 | 1,619 | 0.13 | 0.14 | ||||||||||||||||||||||||
Loss (gain) on sale of property, plant and equipment
|
13 | 8 | 0.00 | 0.00 | (4,652 | ) | (2,884 | ) | (0.24 | ) | (0.25 | ) | ||||||||||||||||||||
Gain on investments, net of income tax | — | (671 | ) | (0.06 | ) | (0.06 | ) | (671 | ) | (0.06 | ) | (0.06 | ) | |||||||||||||||||||
Non-GAAP measures excluding restructuring and other one-time costs, gain on investment, and gain on sale of property, plant and equipment (1)
|
$ | (1,159 | ) | $ | (775 | ) | $ | (0.07 | ) | $ | (0.07 | ) | $ | (2,924 | ) | $ | (2,392 | ) | $ | (0.21 | ) | $ | (0.21 | ) | ||||||||
(1) The non-GAAP measures presented above are not measures of performance under accounting principles generally accepted in the United States of America (“GAAP”). These measures should not be considered a substitute for, and the reader should also consider, income from operations, net earnings, earnings per share and other measures of performance as defined by GAAP as indicators of our performance or profitability. Our non-GAAP measures may not be comparable to other similarly-titled captions of other companies due to differences in the method of calculation.
|
||||||||||||||||||||||||||||||||
Based upon discussions with investors and analysts, we believe that the reader’s understanding of Bel’s performance and profitability is enhanced by reference to these non-GAAP measures. Removal of gains and losses on investments and sales of real estate and charges for severance, plant closure, restructuring, and unauthorized stock issuance costs, inventory-related purchase accounting adjustments and acquisition-related costs facilitates comparisons of our results among reporting periods. We believe that such amounts are not reflective of the underlying business in the period in which the gain or charge is recorded for accounting purposes.
|
||||||||||||||||||||||||||||||||
(2) Net of income tax at effective rate in the applicable tax jurisdiction.
|
||||||||||||||||||||||||||||||||
(3) Individual amounts of earnings (loss) per share may not agree to the total due to rounding.
|
American DG Energy (ADGE) Announces Exclusive Rights Agreement for Europe
WALTHAM, Mass., July 29 /PRNewswire-FirstCall/ — American DG Energy Inc. (NYSE Amex: ADGE), a leading OnSite Utility, offering clean electricity, heat, hot water and cooling solutions to hospitality, healthcare, housing and athletic facilities, today announced that in addition to its rights in the United States, the Company’s European subsidiary, EuroSite Power Inc., now has exclusive rights in Europe to sell all current and future Tecogen Inc. products, deployed with the On-Site Utility business model.
Under the terms of the agreement, EuroSite Power has been granted exclusive representation rights in Europe to all products manufactured by Tecogen which are installed as an On-Site Utility. Tecogen products covered by the agreement include: combined heat and power or cogeneration systems, natural gas chiller cooling systems, ultra high-efficiency heating systems and enhanced emission control systems.
“To add to our promising growth in the United States, American DG Energy’s subsidiary, EuroSite Power, will now be able to take advantage of the current and future products developed by Tecogen for our On-Site Utility energy business,” said John N. Hatsopoulos, Chief Executive Officer of American DG Energy.
About American DG Energy
American DG Energy supplies low-cost energy to its customers through distributed power generating systems. The Company is committed to providing institutional, commercial and small industrial facilities with clean, reliable power, cooling, heat and hot water at lower costs than charged by local utilities – without any capital or start-up costs to the energy user – through its On-Site Utility energy solutions. American DG Energy is headquartered in Waltham, Massachusetts. More information can be found at www.americandg.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. Important factors could cause actual results to differ materially from those indicated by such forward-looking statements, as disclosed on the Company’s website and in Securities and Exchange Commission filings. This press release does not constitute an offer to buy or sell securities by the Company, its subsidiaries or any associated party and is meant purely for informational purposes. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.
Orient Paper (ONP) Announces Preliminary Second Quarter 2010 Financial Results
BAODING, China, July 29 /PRNewswire-Asia-FirstCall/ — Orient Paper, Inc. (AMEX:ONP.a – News) (“Orient Paper” or the “Company”), a leading manufacturer and distributor of diversified paper products in Hebei, China, today announced unaudited preliminary results for the three months ended June 30, 2010. The Company will release full financial results prior to filing its Form 10-Q on or before August 16, 2010 and will hold an earnings conference call to discuss those results.
For the three months ended June 30, 2010, the Company is expecting to report total unaudited revenue increased 70.8%, to approximately $38.3 million from approximately $22.4 million in the same period last year. The Company is also expecting unaudited net income to be approximately $5.0 million, or $0.28 per diluted share, up 102.5% from approximately $2.5 million, or $0.20 per diluted share, for the same period last year.
Mr. Zhenyong Liu, Chairman and Chief Executive Officer, stated, “Our increased second quarter sales were mainly attributable to a combination of factors, including increased average selling prices in our corrugating medium paper and medium-grade offset printing paper products due to the general increase in paper and pulp pricing in the market during the second quarter of 2010, and the increased sales volume of our medium-grade offset printing paper product. In addition, we continued to grow our digital photo paper sales during the second quarter. Our net income growth was attributable to our strong sales growth and our ability to achieve higher gross and operating margins during the quarter. Overall, we are pleased with our preliminary second quarter sales and earnings results and look forward to reporting our full financial results next month.”
About Orient Paper, Inc.
Orient Paper, Inc., through its wholly owned subsidiaries, Shengde Holdings, Inc., controls and operates Baoding Shengde Paper Co., Ltd. (“Baoding Shengde”), and Hebei Baoding Orient Paper Milling Co., Ltd (“HBOP”). Founded in 1996, HBOP is engaged in the production and distribution of products such as corrugating medium paper, offset printing paper, writing paper, and other paper and packaging-related products in China. The Company uses recycled paper as its primary raw material. Baoding Shengde, founded in June 2009 located in Baoding, is engaged in the production and distribution of digital photo paper. As one of the largest paper producers in Hebei Province, China, HBOP is strategically located in Baoding, a city in close proximity to Beijing where the majority of publishing houses are based. Orient Paper is led by an experienced management team committed to diversifying the Company’s product offering and delivering tailored services to its customers. For more information, please visit http://www.orientalpapercorporation.com .
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this announcement are forward-looking statements, including but not limited to, anticipated revenues from the digital photo paper business segment; the actions and initiatives of current and potential competitors; the Company’s ability to introduce new products; the Company’s ability to implement the planned capacity expansion of corrugated medium paper; market acceptance of new products; general economic and business conditions; the ability to attract or retain qualified senior management personnel and research and development staff; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the companies and the industry. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results.
China Armco Metals (CNAM) Commenced Shipments of Metal From Its Recycling Facility
SAN MATEO, CA–(Marketwire – 07/29/10) – China Armco Metals, Inc. (AMEX:CNAM – News), a distributor of imported metal ore and a metal recycler with a new state-of-the-art scrap metal recycling facility in China, today announced that Armet Renewable Resourced Co., Ltd., the Company’s wholly owned subsidiary, commenced shipments of metal from its recycling facility in June of 2010.
The second quarter shipments, totaling approximately 10,000 metric tons, represent the first quantity of end products produced and sold out of the new facility. The facility experienced a delay in ramping production in the second quarter due to power generation issues at the recently completed electric utility company in the Lianyangang enterprise zone which provides power to the area. As those issues have been resolved, management sees production at the facility ramping significantly in the third and fourth quarters as the company looks to deliver on its current supply contracts.
Commenting on the announcement, Mr. Kexuan Yao, CEO and Chairman of China Armco Metals, Inc., stated, “We are pleased to have reached this important milestone for our company. As we now ramp toward our goal of full production and the small startup issues are behind us, we believe the future for our company is brighter than ever. With the contracts, materials, manpower and equipment in place and operational, we now are in a position to realize our growth potential in the coming quarters and years for the benefit of our shareholders.”
About China Armco Metals, Inc.
China Armco Metals, Inc. is engaged in the sale and distribution of metal ore and non-ferrous metals throughout the PRC and has entered the recycling business with the recent launch of operations of a 1-million ton per year shredder and recycler of metals located on 32 acres of land acquired by China Armco. China Armco maintains customers throughout China which includes the fastest growing steel producing mills and foundries in the PRC. Raw materials are supplied from global suppliers in India, Hong Kong, Nigeria, Brazil, Turkey, and the Philippines. China Armco’s product lines include ferrous and non-ferrous ore, iron ore, chrome ore, nickel ore, magnesium, copper ore, manganese ore and steel billet. The recycling facility is expected to be capable of recycling one million metric tons of scrap metal per year which will position China Armco as one of the 10 largest recyclers of scrap metal in China. China Armco estimates the recycled metal market in China as 70 million metric tons. For more information about China Armco, please visit http://www.armcometals.com.
Safe Harbor Statement
In connection with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, China Armco Metals, Inc., is hereby providing cautionary statements identifying important factors that could cause our actual results to differ materially from those projected in forward-looking statements (as defined in such act). Any statements that are not historical facts and that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, indicated through the use of words or phrases such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “intends,” “plans,” “believes” and “projects”) may be forward-looking and may involve estimates and uncertainties which could cause actual results to differ materially from those expressed in the forward-looking statements. These statements include, but are not limited to, our expectations regarding the ability of our suppliers to fulfill their delivery obligations and market prices and revenues related to the sale of processed scrap metal. In addition, any such statements are qualified in their entirety by reference to, and are accompanied by, the following key factors that have a direct bearing on our results of operations:
We caution that the factors described herein could cause actual results to differ materially from those expressed in any forward-looking statements we make and that investors should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors emerge from time to time, and it is not possible for us to predict all of such factors. Further, we cannot assess the impact of each such factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. This press release is qualified in its entirety by our partner’s ability to complete its obligations to source various minerals and ores within acceptable specifications, demand and fluctuations in the prices of those minerals and ores, our ability to resell any sourced minerals and ores at current market prices and on favorable terms, our ability to finance the purchase price of any minerals and ores, and the cautionary statements and risk factor disclosure contained in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2009.
Interface (IFSIA) Declares Regular Quarterly Dividend
ATLANTA, July 29 /PRNewswire-FirstCall/ — Interface, Inc. (Nasdaq:IFSIA – News), a worldwide floorcoverings company and global leader in sustainability, today announced that its Board of Directors has declared a regular quarterly cash dividend of $0.01 per share payable August 27, 2010 to shareholders of record as of August 13, 2010.
Interface, Inc. is the world’s largest manufacturer of modular carpet, which it markets under the InterfaceFLOR, FLOR, Heuga and Bentley Prince Street brands, and, through its Bentley Prince Street brand, enjoys a leading position in the designer quality segment of the broadloom carpet market. The Company is committed to the goal of sustainability and doing business in ways that minimize the impact on the environment while enhancing shareholder value.
ACADIA Pharmaceuticals (ACAD) Announces Initiation of New Phase III Trial with Pimavanserin
SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD – News), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that it has initiated a new Phase III trial designed to evaluate the efficacy, tolerability and safety of pimavanserin as a treatment for patients with Parkinson’s disease psychosis (PDP).
“This Phase III trial builds on the signals of efficacy observed in our earlier PDP studies and uses a refined study design that we expect will help mitigate the placebo response, reduce variability and enhance sensitivity in measuring the efficacy of pimavanserin in PDP patients,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA Pharmaceuticals. “We believe pimavanserin has an ideal profile to effectively treat PDP without impairing motor function and, therefore, provides the potential for an important advance in therapy for patients suffering from this large unmet medical need.”
Trial Design
The new Phase III trial (the -020 Study) is a multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability and safety of pimavanserin in patients with PDP. The -020 Study is expected to enroll about 200 patients at clinical sites located in North America. Patients in the trial will be randomized on a one-to-one basis to two study arms and will receive oral doses of either 40 mg of pimavanserin or placebo once-daily for six weeks. Patients also will continue to receive stable doses of their existing dopamine replacement therapy used to manage the motoric symptoms of Parkinson’s disease. The primary endpoint of the -020 Study is antipsychotic efficacy as measured using a group of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms (SAPS). The primary endpoint will be assessed using centralized ratings. Motoric tolerability will be a key secondary endpoint in the trial and will be measured using Parts II and III of the Unified Parkinson’s Disease Rating Scale (UPDRS).
In addition to the -020 Study, ACADIA is continuing to conduct an open-label safety extension study (the -015 Study) that enrolled patients who completed either of two earlier Phase III PDP trials. Patients who complete the -020 Study also will have the opportunity to enroll in the -015 Study if, in the opinion of the treating physician, the patient may benefit from continued treatment with pimavanserin.
About Pimavanserin
Pimavanserin is a 5-HT2A receptor inverse agonist in Phase III development as a treatment for Parkinson’s disease psychosis. This new chemical entity, which was discovered by ACADIA, is a small molecule that can be taken orally as a tablet once-a-day. ACADIA and Biovail Laboratories International SRL (Biovail), a subsidiary of Biovail Corporation, have formed a collaboration to develop and commercialize pimavanserin for neurological and psychiatric indications, including Parkinson’s disease psychosis, schizophrenia, and Alzheimer’s disease psychosis, in the United States and Canada. ACADIA retains rights to pimavanserin in the rest of the world.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, over 1.5 million people in the United States suffer from Parkinson’s disease. Up to 40 percent of patients with Parkinson’s disease may develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. Currently, there is no therapy in the United States approved to treat PDP. The development of psychosis in patients with Parkinson’s disease often disrupts their ability to perform many of the activities of daily living and is associated with increased caregiver burden, nursing home placement, and increased mortality.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA is developing a portfolio consisting of four product candidates including pimavanserin, which is being developed for three separate neurological and psychiatric indications in collaboration with Biovail. These indications are Parkinson’s disease psychosis, which is in Phase III development, co-therapy for schizophrenia, which is in Phase III planning, and Alzheimer’s disease psychosis, for which ACADIA is planning to initiate a Phase II feasibility study. In addition to pimavanserin, ACADIA has a product candidate in Phase II for chronic pain and a product candidate in Phase I for glaucoma, both in collaboration with Allergan, as well as a product candidate in IND-track development for schizophrenia in collaboration with Meiji Seika Kaisha. All of the product candidates in ACADIA’s product pipeline emanate from discoveries made using its proprietary drug discovery platform. ACADIA maintains a website at www.acadia-pharm.com to which ACADIA regularly posts copies of its press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the design, progress and timing of ACADIA’s drug discovery and development programs, including the -020 Study and ACADIA’s other clinical trials and the results therefrom, and the potential of and the benefits to be derived from clinical trials and product candidates, including pimavanserin. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development and commercialization and collaborations with others, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended December 31, 2009 as well as ACADIA’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Exact Sciences (EXAS) Reports Second-Quarter 2010 Financial Results
MADISON, Wis.–(BUSINESS WIRE)–Exact Sciences Corp. (Nasdaq: EXAS – News) today announced its financial results for the second quarter ended June 30, 2010.
Exact reported total revenues of $1.3 million for the second quarter of 2010, compared to total revenues of $1.3 million during the same period of 2009. Total revenues for the first six months of 2010 were $2.6 million, compared to total revenues of $2.3 million for the same period of 2009.
Exact reported a net loss of ($2.5) million, or ($0.06) a share, for the second quarter of 2010. The company had a net loss of ($2.4) million, or ($0.08) a share, for the same period of 2009. Exact’s net loss for the six-month period ended June 30, 2010, was ($4.6) million, or ($0.12) a share, compared to ($6.2) million, or ($0.21) a share, for the same period of 2009.
Operating expenses for the second quarter of 2010 were $3.8 million, compared to $3.7 million for the same period of 2009. Operating expenses for the first six months of 2010 were $7.2 million, compared to $8.6 million for the same period of 2009. Operating expenses for the six months ended June 30, 2010, were lower primarily due to one-time expenses incurred during the first quarter of 2009, associated with the company’s strategic transaction with Genzyme, and severance and stock option expense related to last year’s management change.
Exact ended the second quarter of 2010 with cash, cash equivalents and marketable securities of $37.3 million, compared to $24.3 million at Dec. 31, 2009. The company completed a $17.6 million common stock offering during the quarter.
“We remained focused on our key priorities during the second quarter, all of which are a part of our mission of making colon cancer eradication possible through an accurate, patient-friendly screening test,” said Kevin T. Conroy, the company’s president and chief executive. “We continue to make refinements to our test. These improvements include a new patient sampling kit, a biomarker panel that provides near universal coverage of cancer and precancer, and an improved DNA detection method that enables greater sensitivity and specificity.”
“Our validation study remains on track and we look forward to announcing the results of the study and discussing the performance of our test at the American Association of Cancer Research meeting in Philadelphia on October 29. In the meantime, we’re excited to be sharing new data today at the American Association of Clinical Chemistry meeting demonstrating that our quantitative detection chemistry detected 100 percent of colorectal cancers and precancers in a preliminary study with colorectal tissue,” Mr. Conroy said.
Conference Call & Webcast with PowerPoint Presentation
Company management will host a conference call and webcast on Wednesday, July 28, 2010, at 10 a.m. EDT to discuss second-quarter 2010 results. The webcast will include a PowerPoint slide presentation highlighting the company’s second-quarter accomplishments and ongoing corporate activities. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-212-6082 and international callers should dial 707-287-9332. The access code for both domestic and international callers is 89493587. Please dial in five to 10 minutes prior to the start of conference call. A replay of the conference call will be available at the company’s website. The conference call, webcast and replay are open to all interested parties.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company’s website at www.exactsciences.com.
Certain statements made in this press contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected license fee revenues, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports of Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
EXACT SCIENCES CORPORATION | ||||||||||||||||||
Selected Unaudited Financial Information | ||||||||||||||||||
Condensed Consolidated Statements of Operation Data | ||||||||||||||||||
(Amounts in thousands, except per share data)
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Three Months Ended | Six Months Ended | |||||||||||||||||
June 30, | June 30, | |||||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||||
Revenue: | ||||||||||||||||||
Product royalty fees | $ | 7 | $ | 11 | $ | 19 | $ | 18 | ||||||||||
License fees | 1,307 | 1,247 | 2,594 | 2,240 | ||||||||||||||
1,314 | 1,258 | 2,613 | 2,258 | |||||||||||||||
Cost of revenue: | ||||||||||||||||||
Product royalty fees | 6 | 8 | 12 | 8 | ||||||||||||||
Gross profit: | 1,308 | 1,250 | 2,601 | 2,250 | ||||||||||||||
Operating Expenses: | ||||||||||||||||||
Research and development | 2,123 | 2,015 | 3,918 | 2,123 | ||||||||||||||
General and administrative | 1,339 | 1,638 | 2,851 | 6,406 | ||||||||||||||
Sales and marketing | 330 | 40 | 439 | 40 | ||||||||||||||
Restructuring | – | – | – | (3 | ) | |||||||||||||
3,792 | 3,693 | 7,208 | 8,566 | |||||||||||||||
Loss from operations | (2,484 | ) | (2,443 | ) | (4,607 | ) | (6,316 | ) | ||||||||||
Interest income | 7 | 49 | 6 | 83 | ||||||||||||||
Net loss | $ | (2,477 | ) | $ | (2,394 | ) | $ | (4,601 | ) | $ | (6,233 | ) | ||||||
Net loss per share – basic and diluted | $ | (0.06 | ) | $ | (0.08 | ) | $ | (0.12 | ) | $ | (0.21 | ) | ||||||
Weighted average common shares | ||||||||||||||||||
outstanding – basic and diluted | 39,067 | 31,283 | 37,347 | 30,360 | ||||||||||||||
EXACT SCIENCES CORPORATION | ||||||||||||||||||
Selected Unaudited Financial Information | ||||||||||||||||||
Condensed Consolidated Balance Sheet Data | ||||||||||||||||||
(Amounts in thousands) | ||||||||||||||||||
June 30,
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December 31, | |||||||||||||||||
2010 | 2009 | |||||||||||||||||
Assets | ||||||||||||||||||
Cash and cash equivalents | $ | 24,232 | $ | 21,924 | ||||||||||||||
Marketable securities | 13,092 | 2,404 | ||||||||||||||||
Prepaid expenses and other current assets | 533 | 484 | ||||||||||||||||
Restricted cash | 500 | 500 | ||||||||||||||||
Property and equipment, net | 737 | 458 | ||||||||||||||||
Total assets | $ | 39,094 | $ | 25,770 | ||||||||||||||
Liabilities and stockholders’ equity | ||||||||||||||||||
Total current liabilities | $ | 7,584 | $ | 6,526 | ||||||||||||||
Third party royalty obligation, less current portion | – | 988 | ||||||||||||||||
Long term debt | 1,000 | 1,000 | ||||||||||||||||
Long term accrued interest | 11 | 1 | ||||||||||||||||
Deferred license fees, less current portion | 9,964 | 11,161 | ||||||||||||||||
Total stockholders’ equity | 20,535 | 6,094 | ||||||||||||||||
Total liabilities and stockholders’ equity | $ | 39,094 | $ | 25,770 |
Exact Sciences’ (EXAS) Methylation Detection Technology Achieves 100 Percent Sensitivity, Specificity
ANAHEIM, Calif.–(BUSINESS WIRE)–Exact Sciences Corp. (Nasdaq: EXAS – News) today announced that data being presented this afternoon at the annual meeting of the American Association of Clinical Chemistry (AACC) demonstrates that its methylation specific technology, using a combination of DNA methylation markers, detected 100 percent of colorectal cancers and precancers at a specificity cutoff of 100 percent in a preliminary study with colorectal tissue.
The study data also showed that the methylation specific technology was able to detect fewer than 10 copies of methylated DNA. The technology also demonstrated the ability to discriminate 10 copies of methylated DNA target in an unmethylated target population of 100,000 copies.
“The data being presented today at AACC illustrates the groundbreaking approach Exact Sciences is taking to the detection of both colorectal cancers and precancers,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “We believe our study is the first time that any set of markers has achieved 100 percent discrimination of both colorectal cancers and precancers from normal tissue. While we believe the performance of these markers will be diminished in stool samples, the 100 percent sensitivity and specificity they demonstrated in tissue samples gives us confidence about achieving our goal of greater than 85 percent and 50 percent cancer and precancer sensitivity, respectively, in our upcoming validation study, which will include approximately 1,650 stool samples.”
DNA methylation regulates gene expression, the process that converts the information in DNA into proteins. Scientific studies have shown that methylation markers are clinically relevant for the detection of colorectal cancers and precancers. Methylation markers are typically present more frequently than individual DNA mutation markers in colorectal cancers and precancers and, as a result, fewer methylation markers are required to detect them.
The data is being presented at the AACC meeting in a poster titled “Sensitive Quantification of Methylated Markers with a Novel Methylation Specific Technology.” The study was a collaboration of Exact Sciences and Mayo Clinic.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company’s website at www.exactsciences.com.
Certain statements made in this press contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected license fee revenues, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports of Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Dreams, Inc. (DRJ) Adds University of Texas Athletics to Syndication Portfolio
PLANTATION, Fla.–(BUSINESS WIRE)–Dreams, Inc. (NYSE Amex: DRJ), a vertically integrated leader in the licensed sports products industry, announced that it has signed a letter of intent to acquire Collegiate Marketing Services (CMS) of Overland Park, Kan. CMS has since 2005 managed the retail, game day and online merchandise operations for The University of Texas Athletics program. Terms of the deal were not disclosed. The acquisition, when completed, will include the management of Longhorns, LTD retail operations at Darrell K Royal-Texas Memorial Stadium and other UT sports venues, as well as the official online store LonghornsLTD.com. Dreams is launching the new official Longhorns store on its propriety ecommerce platform.
“The acquisition of CMS brings one of the nation’s most respected and largest college programs into our syndication portfolio,” stated Kevin Bates, President of Dreams Retail, a division of Dreams, Inc. “We are fully committed to the Longhorns brand and will work relentlessly to grow their business, enhance their customer experience, and represent Texas as the premier college in the country.”
Bates added, “This acquisition also marks our entrance into game day stadium operations, thus opening a whole new channel of business for us. Over the past few years, we have been strategically populating our roster with many game day stadium operations experts. We now have an experienced management staff with more than 80 years of collective experience running stadium operations, satellite stores and other team retail events for more than 20 different professional teams and colleges. This will allow us to deliver a comprehensive retail solution to current and prospective clients that are looking for a provider who excels both at e-commerce and in-stadium operations and merchandising.”
Steve Ballard, CEO of CMS stated, “Dreams’ acquisition of CMS will be a big win for both companies. The strength of CMS’s game day and retail management will now be merged with the top online merchandise platform in the business. The ability to maximize sales across all channels of business for our clients is exciting. We are thrilled to be joining such a successful and fast growing organization.”
Dreams anticipates a closing within 30 days, which is subject to execution of definitive documents, Board of Directors and Bank approvals.
DREAMS, INC. trades under the ticker symbol: NYSE Amex: DRJ
Statements contained in this press release, which are not historical facts, are forward looking statements. The forward-looking statements in this press release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such statements are indicated by words or phrases such as “anticipates,” “projects,” “management believes,” “Dreams believes,” “intends,” “expects,” and similar words or phrases. Such factors include, among others, the following: competition; seasonality; success of operating initiatives; new product development and introduction schedules; acceptance of new product offerings; franchise sales; advertising and promotional efforts; adverse publicity; expansion of the franchise chain; availability, locations and terms of sites for franchise development; changes in business strategy or development plans; availability and terms of capital including the continuing availability of our credit facility with Regions Bank or a similar facility with another financial institution; labor and employee benefit costs; changes in government regulations; and other factors particular to the Company.
The Eastern Company (EML) Reports Results for the Second Quarter and Six Months of 2010
NAUGATUCK, Conn.–(BUSINESS WIRE)–The Eastern Company (NYSE Amex-EML) today announced the results of its operations for the second quarter and six months of 2010. Sales for the quarter were $32.6 million, compared to $28.1 million for the same period in 2009, a 16% increase, while net income was $1.4 million or $0.23 per diluted share, compared to the $842,000, or $0.13 per diluted share, reported in the second quarter of 2009, a 67% increase.
Net sales for the six months of 2010 were $63.5 million compared to $56.5 million for the first six months of 2009, a 12% increase. For the six month period ended July 3, 2010 net income was $2.4 million or $0.40 per diluted share, compared to a loss of ($240,000) or ($.04) per diluted share for the same period in 2009.
Mr. Leganza Chairman, President and CEO stated, “All three of our business segments experienced increased sales and earnings as compared to the second quarter and first six months of 2009, an upward trend which began in the first quarter of this year. While we have experienced our sales increase in almost all of the markets we serve, we believe it is yet too early to conclude whether or not the economy will continue to sustain itself and get stronger. However, we feel very positive and confident about our business plans and objectives for 2010 and continue to anticipate an overall improvement in sales and earnings for the year. The cost and expense reductions we implemented during 2009 have been important toward providing positive earnings results across all our business segments.”
Leonard F. Leganza, added, “The Metal Products Group has benefited from the strong demand for coal. The mining industry is, as a consequence, expected to remain robust in the foreseeable future. The $2.5 million production improvement plan we initiated is on schedule with the major installations to take place during the early part of August. No disruptions of customer service are anticipated.”
Mr. Leganza, continued, “The Industrial Hardware Group is benefiting from the demand for products utilizing our lightweight composite panels. Sales of those products are anticipated to improve because of the greater demand for Class 8 sleeper cabs as well as panels for delivery truck applications and the introduction of other new products. The Security Products Group continued to benefit from stronger demand for lock products in the majority of the markets we serve. The commercial laundry markets, which are also served by the Security Products Group, continued, however, to experience softness which we believe to be the result of general economic factors. New products which are targeted at the commercial laundry markets include advanced coin recognition systems and contactless and wireless cash payment systems. These products were introduced during the second quarter of 2010 and we anticipate several new market opportunities will open up for us in the coin vending and metering industry.”
Mr. Leganza concluded, “While we remain cautiously optimistic about the current state of the economy, we expect that all of our business segments will experience growth in sales and earnings for the full year compared to 2009. We also believe our liquidity plans will be sufficient to support our current dividend policy, meet our debt service requirements and replace or upgrade our capital equipment where needed. We will continue to take whatever measures are necessary to enhance our liquidity position during 2010, and as always, take whatever further action may be necessary to improve our operating results and pursue our strategic initiatives.”
The Eastern Company is a 152-year-old manufacturer of industrial hardware, security products and metal castings. It operates from nine locations in the U.S., Canada, Mexico, Taiwan and China. The diversity of the Company’s products helps it to respond to the changing requirements of a broad array of markets.
Forward-Looking Statements: Information in this news release contains statements which reflect the Company’s current expectations regarding its future operating performance and achievements. Actual results may differ due to the many economic uncertainties that affect the Company’s business environment. Further information about the potential factors which could affect the Company’s financial results is included in the Company’s reports and filings with the Securities and Exchange Commission. The Company is not obligated to update or revise the aforementioned statements for those new developments.
Statement of Consolidated Income (unaudited) | ||||||||||||||
THE EASTERN COMPANY (NYSE Amex – EML) | ||||||||||||||
THREE Months Ended | SIX Months Ended | |||||||||||||
13 wks | 13 wks | 26 wks | 26 wks | |||||||||||
July 3, 2010 | July 4, 2009 | July 3, 2010 | July 4, 2009 | |||||||||||
Net Sales | $ | 32,577,665 | $ | 28,087,629 | $ | 63,532,220 | $ | 56,520,102 | ||||||
Net Income | $ | 1,410,869 | $ | 842,382 | $ | 2,420,529 | $ | (240,148 | ) | |||||
Net Income Per Share: | ||||||||||||||
Basic | $ | 0.23 | $ | 0.14 | $ | 0.40 | $ | (0.04 | ) | |||||
Diluted | $ | 0.23 | $ | 0.13 | $ | 0.39 | $ | (0.04 | ) | |||||
Weighted average shares outstandings: | ||||||||||||||
Basic | 6,074,700 | 5,967,826 | 6,069,977 | 5,966,787 | ||||||||||
Diluted | 6,165,369 | 6,268,805 | 6,177,847 | 5,966,787 |
Stream (SGS) Unveils Technology Strategy Designed to Maximize Operational Efficiency and Increase Customer Lifetime Value
BOSTON–(BUSINESS WIRE)–Stream Global Services, Inc. (NYSE AMEX: SGS), a premium, global business process outsource (BPO) service provider specializing in customer relationship management services for Fortune 1000 companies, today announced xStream Interactions, its comprehensive technology strategy and platform, designed specifically to improve operational efficiencies and drive long-term customer value for its clients. The xStream Interactions platform consists of three product or service “families” – Performance Studio, a collection of agent-productivity desktop solutions designed to enhance effectiveness and efficiency; Communications Services, hosted services for customer interactions; and Analytic Solutions, a suite of robust, real-time analytic solutions intended to enhance the customer experience and improve lifetime value. Stream’s technology platform will provide the ability to extend the contact center into enterprise, offer real-time analytics at point of interaction and deliver agent tools that provide timely feedback and knowledge. Stream is also announcing today the immediate availability of its first Performance Studio product, Navigator.
For each client program, Stream works with various external and proprietary client systems, each with its own set of applications and business processes. The result is complex user interfaces and workflows. Navigator automates these business process workflows that span disparate systems and applications within the contact center infrastructure. By utilizing Navigator, Stream is able to optimize service professional productivity, reduce handle times, improve cross-sell and up-sell performance and enhance overall customer satisfaction by driving brand loyalty for its clients.
As additional technology offerings are available from Stream, Navigator will seamlessly integrate with those as well, acting as a “portal” into Stream’s complete roster of available technology solutions. Navigator is currently in deployment for one of Stream’s Fortune 100 clients and is delivering enhanced service to its customers with reduced average handling times and improved first call resolution rates.
Specific Navigator features include:
- Integrated Applications – provides single sign-on capability for multiple applications, thus improving overall service professional productivity
- Automates Processes – eliminates the need for repetitive tasks, therefore increasing focus on the customer and reducing average handle time
- Extends Functionality – becomes a portal into Stream’s technology offerings, aggregating multiple applications – including real-time analytics – into one, front-end interface
- Builds Composite Applications – provides quick and easy access to direct links and lookups
- Exposes Additional Services – predicts and launches revenue generating opportunities for the service professional following a technical support or customer care interaction
“At Stream, we understand companies operating in today’s volatile economy face an increasing demand to reduce their overall operating costs, while still driving customer loyalty and revenue,” said Bob Lyons, Chief Technology and Information Officer of Stream Global Services. “Navigator, and our entire technology platform, has been designed specifically to address this need. Our forward-thinking technology strategy ensures that we are positioned to offer our current and future clients the best platform and technology solutions possible for driving customer value up, while driving cost down. We look forward to unveiling additional technology services and solutions in the coming months that will help us deliver on our mission of continually providing innovative service solutions to our clients that create maximum value to their customers.”
For more information on the Navigator and Stream’s complete technology offering, please visit http://www.stream.com.
About Stream Global Services, Inc.
Stream Global Services is a premium business process outsource (BPO) service provider specializing in customer relationship management including sales, customer care and technical support for Fortune 1000 companies. Stream is a trusted partner to some of the world’s leading technology, computing, telecommunications, retail, entertainment/media, and financial services companies. Our service programs are delivered through a set of standardized best practices and sophisticated technologies by a highly skilled workforce of approximately 30,000 employees based out of 50 locations in 22 countries supporting more than 35 languages. Stream continues to expand its global presence and service offerings to increase revenue, improve operational efficiencies and drive brand loyalty for its clients. To learn more about the company and its complete service offering, please visit www.stream.com.
Caraco Pharmaceutical Laboratories, Ltd. (CPD) Reports Results for the First Quarter of Fiscal Year 2011
DETROIT, July 27 /PRNewswire-FirstCall/ — Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) recorded net sales of $130.0 million during the first quarter of Fiscal 2011 compared to $48.1 million during the first quarter of Fiscal 2010. During the first quarter of Fiscal 2011, the sales of Caraco-owned products were $2.9 million, as compared to $13.1 million during the corresponding period of Fiscal 2010, while the sales of distributed products during the first quarter of Fiscal 2011 were $127.1 million, as compared to $35.0 million during the corresponding period of Fiscal 2010. Caraco earned a gross profit of $9.5 million during the first quarter Fiscal 2011, as compared to incurring a gross loss of $3.6 million during the corresponding period of Fiscal 2010. The gross loss in the first quarter of Fiscal 2010 was, in large part, due to a reserve of $8.4 million created by the Company, for the inventory seized by the FDA. The Company earned pre-tax income of $1.9 million during the first quarter of Fiscal 2011, as compared to incurring a pre-tax loss of $14.4 million during the corresponding period of Fiscal 2010. Pre-tax income in the first quarter of Fiscal 2011 is higher due to increased sales of certain distributed products. The sales of such products at these levels are not expected to continue in future periods. Caraco earned net income of $1.2 million during the first quarter of Fiscal 2011, as compared to incurring a net loss of $9.4 million during the corresponding period of Fiscal 2010. The Company generated cash from operations in the amount of $3.3 million during the first quarter of Fiscal 2011, as compared to generating cash from operations in the amount of $1.4 million during the corresponding period of Fiscal 2010.
Selling, general and administrative (“SG&A”) expenses during the first quarter of Fiscal 2011 were $5.8 million, as compared to $3.7 million during the corresponding period of Fiscal 2010, representing an increase of 60%. SG&A expenses were higher during Fiscal 2011 as the Company recorded additional expenses primarily related to professional consultation fees pertaining to FDA issues. SG&A expenses, as a percentage of net sales decreased to 4% for the first quarter of Fiscal 2011, as compared to 8% for the corresponding period of Fiscal 2010. The lower percentage of SG&A is mainly due to the higher sales in the current period versus the corresponding period last year.
Total R&D expenses incurred for the first quarter of Fiscal 2011 were $2.1 million, as compared to $7.1 million during the corresponding period of Fiscal 2010. Although R&D expenses have decreased in the current period due to the focus of the Company on remediating FDA concerns, they are likely to increase once the Company refocuses on new product filings and approvals with the FDA.
Caraco filed two ANDAs relating to two products with the FDA during the first quarter of Fiscal 2011. The total number of ANDAs pending approval by the FDA as of June 30, 2010 was 33 (including four tentative approvals) relating to 29 products.
The Company has been actively working with cGMP consultants towards the resumption of manufacturing activities at its Michigan facilities. These consultants were appointed by the Company in accordance with the previously disclosed Consent Decree, which the Company entered into with the FDA on September 29, 2009. The FDA approved the Company’s work plan on March 17, 2010, and the Company is in the process of implementing the corrective actions and remedial measures as stipulated in the work plan. On June 24, 2010, the FDA notified Caraco that its protocol for third party cGMP certification, detailing the activities to be conducted by the cGMP experts, was acceptable. Caraco’s cessation of manufacturing operations will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations. Caraco intends to continue to work with the FDA to resolve its concerns as effectively and expeditiously as possible. However, there is no assurance that the steps being taken will be successful or result in resolution of the FDA complaint.
On June 25, 2010 the FDA released certain previously seized raw materials which had been opened solely for the purpose of sampling.
This press release should be read in conjunction with Caraco’s annual report on Form 10-Q which will provide more detailed information on the results for the first quarter of Fiscal 2011.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limitation, the words “believe” or “expect” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation’s filings with the Securities and Exchange Commission, including Part I, Item 1A of our most recent Form 10-K, and include but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, material litigation from product recalls, the purported class action lawsuits alleging federal securities laws violations, delays in returning the Company’s products to market, including loss of market share, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
|||||
(A subsidiary of Sun Pharmaceutical Industries Limited) |
|||||
STATEMENTS OF OPERATIONS (UNAUDITED) |
|||||
Three months ended June 30, |
|||||
2010 |
2009 |
||||
Net sales |
$ 130,028,760 |
$ 48,070,016 |
|||
Cost of goods sold |
120,487,714 |
51,679,584 |
|||
Gross profit (loss) |
9,541,046 |
(3,609,568) |
|||
Selling, general and administrative expenses |
5,839,240 |
3,659,211 |
|||
Research and development costs |
2,119,099 |
7,085,135 |
|||
Operating income (loss) |
1,582,707 |
(14,353,914) |
|||
Other income (expense) | |||||
Interest expense |
(198,264) |
(130,950) |
|||
Interest income |
498,607 |
104,455 |
|||
Loss on sale of equipment |
– |
(114,272) |
|||
Other income |
– |
46,298 |
|||
Other income (expense) – net |
300,343 |
(94,469) |
|||
Income (loss) before income taxes |
1,883,050 |
(14,448,383) |
|||
Income tax expense (benefit) |
673,282 |
(5,025,332) |
|||
Net income (loss) |
$ 1,209,768 |
$ (9,423,051) |
|||
Net income (loss) per common share | |||||
Basic |
$ 0.03 |
$ (0.25) |
|||
Diluted |
$ 0.03 |
$ (0.25) |
|||
Weighted number of shares | |||||
Basic |
39,090,194 |
37,547,864 |
|||
Diluted |
40,468,694 |
37,547,864 |
Uranium Energy Corp (UEC) Issues Mid-Year Shareholder Report
– Highlights Include Construction Status of Palangana ISR Project, and
– Initial Uranium Production Scheduled for the Fourth Quarter
NYSE Amex Equities Exchange Symbol – UEC
CORPUS CHRISTI, TX, July 27 /PRNewswire-FirstCall/ – Uranium Energy Corp (NYSE-AMEX: UEC, the ‘Company’) today issued a Mid-Year Shareholder Report and filed an 8-K statement advising on the progress of its Palangana in-situ recovery (ISR) project in South Texas, which is scheduled to commence production in the fourth quarter of this year. The report from CEO Amir Adnani follows in its complete form:
Dear Shareholder,
I am pleased to provide a mid-year report for Uranium Energy Corp. The first half of the year has truly been a breakthrough for the Company, as we demonstrate with a number of particulars in this letter. The second half of the year promises to bring all of our work to fruition with the start of initial uranium production at the Palangana ISR project, on track for the fourth quarter of this year. This will put UEC in a very elite class as one of only eight uranium producers in the world.
The Company’s Annual General Meeting was held last week on July 22, and I would like to express my gratitude to you, our shareholders, for your continued trust and support. The entire UEC team deserves a special acknowledgement for their dedication and hard work, as do our directors for their experienced leadership. Thank you!
Also, considering that the economy and investment markets continue to experience difficulties, I want to reassure you that the Company is well funded to execute its plans. Uranium Energy Corp has no debt and approximately $22 million in cash, funds that are in excess of the remaining development costs to start cash flow.
Palangana Production Watch --------------------------
With the plans to initiate in-situ recovery of uranium at Palangana in South Texas in four months, I want to tell you – and show you – what to start to expect. This area is alive with rigs, trucks, pipes and roads going in for production. In addition, two rigs are actively drilling to the east, north and south of the first production area, Production Area One (PAA-1), generating additional uranium potential. We feel good about the prospects for growing our resource base in South Texas to feed our recently acquired Hobson processing plant, which is fully licensed and permitted and ready to process uranium immediately.
To view the images and descriptions, please click on these links: -----------------------------------------------------------------
Wellfield Development:
http://uraniumenergy.com/projects/texas/palangana/index.php?&content_id=358
Drilling Disposal Well:
http://uraniumenergy.com/projects/texas/palangana/index.php?&content_id=359
Hobson Processing Plant:
http://uraniumenergy.com/projects/texas/hobson/index.php?&content_id=360
Management takes great pride in current photographs of these activities because Uranium Energy Corp is the only company in North America that is in the position to start major production of uranium in the near-term with all necessary permits secured.
We initiated wellfield development and construction early in June at PAA-1, with 110 injection and production wells to be drilled, cased and completed. Concurrently, we started drilling the disposal well for this first wellfield, which is now complete. Roads are going in, and the electricity is on. Shortly we will initiate construction of the on-site ion-exchange facility. The equipment, tanks and pipes for this facility have been purchased and tested, and are now ready for installation, anticipated in the next two months.
These activities are being supervised and coordinated under the watchful and experienced control of Chief Operating Officer, Harry Anthony – who earlier supervised ISR production at Palangana on behalf of Union Carbide in the 1970s – and Vice President of Production, Robert Underdown.
Meanwhile, approximately one hundred miles north at the Company’s Hobson central processing plant, all systems are ready to receive and process the first truckloads of resins from PAA-1 into uranium oxide (commonly referred to as U3O8 or yellowcake), with first deliveries expected by November this year.
Additional Achievements in the First Half of 2010 ------------------------------------------------- - Sale of non-core asset - In April the Company completed the sale of its 49% interest in the Cibola Resources LLC joint venture located in New Mexico for $11 million in cash, valuable non-dilutive funds ensuring that the Company's balance sheet is strong. - Permitting advances - In January, the TCEQ approved the final permits for production at Palangana. In addition, at the Goliad ISR project, the crucial disposal well permits were received in May. Also, a public hearing was completed that was needed before the completion of final permits for production at Goliad, anticipated later this year. - Increasing uranium resources - In February, the Company announced its first NI 43-101-qualified resource at Palangana. The independent Technical Report provides for a resource of 2.2 million pounds U3O8 in all categories. Based on very successful drilling throughout the year on several zones at Palangana, the Company is confident of expanding this defined resource before the end of this year. This is in addition to 6.9 million pounds of in-situ uranium in all categories of resource at our Goliad ISR project, plus 1.3 million pounds at Nichols and a 1.5 million pound historical resource at the Company's Salvo project. All of these ISR uranium projects are in close proximity to the Company's Hobson processing plant, part of UEC's regional operating strategy in Texas. - Media and analyst coverage - The Company gained excellent recognition from the media during this period as America's next uranium producer. We had a feature article in Forbes magazine in April. I was interviewed by Bloomberg and Reuters, and both interviews became the basis for articles, transmitted globally in each instance. In addition, six recognized analysts now track the developments of the Company in Canada and the U.S. - Russell 2000 indexes - Uranium Energy Corp was reinstated to the Russell 2000 Index and the Russell 3000 Index as published on June 29 by Russell Investment Group. Moving Forward: Near-Term Production and Cash Flow --------------------------------------------------
Our key objective is initial production and cash flow. With an engineering team comprised of many of the top pioneers of the ISR method of uranium mining, we are well positioned to benefit from this low cost production profile. Several additional targets are anticipated to complete this year that will add immeasurably to the Company’s near-future. Please keep an eye out for these developments later this year:
- An updated resource statement for Palangana - Further and significant information regarding the Company's Salvo project - Permitting advances for Goliad, which is targeted for initial production next year - Additional expansion with highly prospective new leases Nuclear Power Industry Gaining Traction ---------------------------------------
President Obama got the industry off to a strong start in his State of the Union address in January by emphasizing that the country’s nuclear power capacity must increase because it is a key to America’s energy future. The Administration followed this up emphatically in February by earmarking approximately $54 billion for federal loan guarantees for new nuclear reactors. And they acted quickly to grant the first $8 billion in loan guarantees to Southern Co. for the construction of two reactors in Georgia.
Bloomberg recently reported that China is tying up large amounts of future uranium production in long-term contracts, perhaps signaling that uranium prices are headed higher in the second half of 2010, as indicated by this week’s jump of $4.25 to $46/lb in the spot price. This report follows several actions through the early months of the year by Chinese, Japanese, Korean and Russian utilities and traders that are buying uranium companies and projects globally. Not only do these actions tend to cause the price of uranium to rise, they clearly reduce the amount of uranium available for others, and most notably for the U.S. utilities, which operate nearly 25% of the world’s reactors, and plan to expand capacity by another 31% by 2020.
Uranium Prices --------------
We are optimistic about the price of uranium. It has built a base above $40/lb for over a year, and is anticipated by a majority of analysts to rise later this year or next year. In fact, yesterday, spot uranium price moved up to $46/lb, a jump of $4.25. Throughout the industry, demand far exceeds supply on both a global and local-U.S. basis for now and the foreseeable future. The term, or long-term contract price, appears to be stable at $60/lb, a highly workable level for us.
The Company’s plan is to be THE low-cost leader using the state-of-the-art ISR method of production. The advantages of ISR include a very low capital expenditure to get into production; a projected low cost of production; a better profit margin and a friendlier relationship with the environment.
Uranium Energy Corp. is advancing at a rapid pace. With initial production this year, we anticipate this momentum to increase. We appreciate your trust in the progress of the company, and welcome your additional participation.
Please stay in touch with us by visiting www.uraniumenergy.com, emailing info@uraniumenergy.com or calling us any time at 1-866-748-1030.
Yours sincerely, "Amir Adnani" Amir Adnani President and CEO Uranium Energy Corp
About Uranium Energy Corp
Uranium Energy Corp. (NYSE-AMEX: UEC) is a U.S.-based exploration and development company with the objective of near-term uranium production in the U.S. The Company’s fully licensed and permitted Hobson processing facility is central to all of its projects in South Texas, including the fully-permitted Palangana in-situ recovery project, and the Goliad in-situ recovery project which is in the final stages of mine permitting for production. The Company’s operations are managed by professionals with a recognized profile for excellence in their industry, a profile based on many decades of hands-on experience in the key facets of uranium exploration, development and mining.
Stock Exchange Information: NYSE-AMEX: UEC Frankfurt Stock Exchange Symbol: U6Z WKN: AØJDRR ISN: US916896103
Notice to U.S. Investors
The mineral resources referred to herein have been estimated in accordance with the definition standards on mineral resources of the Canadian Institute of Mining, Metallurgy and Petroleum referred to in NI 43-101 and are not compliant with U.S. Securities and Exchange Commission (the “SEC”) Industry Guide 7 guidelines. In addition, measured mineral resources, indicated mineral resources and inferred mineral resources, while recognized and required by Canadian regulations, are not defined terms under SEC Industry Guide 7 and are normally not permitted to be used in reports and registration statements filed with the SEC. Accordingly, we have not reported them in the United States.
Investors are cautioned not to assume that any part or all of the mineral resources in these categories will ever be converted into mineral reserves. These terms have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. In particular, it should be noted that mineral resources which are not mineral reserves do not have demonstrated economic viability. It cannot be assumed that all or any part of measured mineral resources, indicated mineral resources or inferred mineral resources will ever be upgraded to a higher category. In accordance with Canadian rules, estimates of inferred mineral resources cannot form the basis of feasibility or other economic studies. Investors are cautioned not to assume that any part of the reported measured mineral resources indicated mineral resources or inferred mineral resources referred to in this news release and in the Technical Report are economically or legally mineable.
Safe Harbor Statement
Except for the statements of historical fact contained herein, the information presented in this news release constitutes “forward-looking statements” as such term is used in applicable United States and Canadian laws. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. Any other statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects” or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans, “estimates” or “intends”, or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved) are not statements of historical fact and should be viewed as “forward-looking statements”. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such risks and other factors include, among others, the actual results of exploration activities, variations in the underlying assumptions associated with the estimation or realization of mineral resources, the availability of capital to fund programs and the resulting dilution caused by the raising of capital through the sale of shares, accidents, labour disputes and other risks of the mining industry including, without limitation, those associated with the environment, delays in obtaining governmental approvals, permits or financing or in the completion of development or construction activities, title disputes or claims limitations on insurance coverage. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements contained in this news release and in any document referred to in this news release.
Hologic (HOLX) Announces Panel Date For Its Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System
BEDFORD, Mass., July 27 /PRNewswire-FirstCall/ — Hologic, Inc. (Hologic or the Company) (Nasdaq:HOLX – News), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the Company’s Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system has been scheduled to be reviewed by the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) on September 24, 2010 as part of the Company’s pre-market approval (“PMA”) application. The PMA application being reviewed was originally filed in 2008 and subsequently updated with additional data, and seeks approval of the use of the system for both screening and diagnostics. In addition, the Company is conducting a number of additional clinical trials for a separate FDA submission expected to be filed at a later date. Hologic’s 3-D imaging technology, “Selenia Dimensions,” is available commercially in more than a dozen countries, including countries in Europe, the Middle East, South America, Asia and Australia. In North America, commercial Selenia Dimensions systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional (2-D) only system that is upgradeable to do breast tomosynthesis (3-D) imaging when and if the product is approved by the FDA.
The Hologic Selenia Dimensions digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a 2-D image, breast tomosynthesis produces a 3-D image.
“Over the past several years, Hologic has been diligently working on new technologies, most notably the development of breast tomosynthesis,” said Rob Cascella, President and Chief Executive Officer. “This Panel review of our Selenia Dimensions breast tomosynthesis system is part of the FDA process of assessing this remarkable new technology. The system is specifically designed to address the primary limitation of 2-D digital mammography, namely the superposition of normal breast anatomy that may mask a breast cancer. We believe tomosynthesis represents the next phase in breast cancer detection – fast, high-quality 3-D imaging of the breast. We are thrilled to have a Panel date set for September as an important step in the review of our next-generation technology.”
Company management will discuss this Panel date in more detail during our scheduled conference call on Monday, August 2, 2010, at 5:00 p.m. (Eastern) for our third quarter fiscal 2010 operating results. Interested participants may listen to the call by dialing 888-503-8177 or 719-325-2318 for international callers and referencing access code 3392847 approximately 15 minutes prior to the call.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic’s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.
Hologic, Dimensions and Selenia, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.
Forward Looking Disclaimer
This News Release contains forward-looking information that involves known and unknown risks and uncertainties, including statements about the expected timing of the Panel review of Hologic’s Selenia Dimensions digital breast tomosynthesis system, and the anticipated benefits of that system. The Panel review is only one step in the FDA’s review process and can be rescheduled or cancelled at any time. Hologic is unable to predict the outcome of the Panel review, and there can be no assurance that the Panel will recommend that the FDA approve Hologic’s system for either screening or diagnostics. Even if the Panel were to make such recommendation, there can be no assurance that the FDA would approve Hologic’s system for either use on a timely basis, if at all. In addition, even if approved, the FDA could impose conditions to such approval that would significantly limit the use or commercialization of the system. Moreover, there can be no assurance the system will achieve the anticipated benefits described herein, or that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Among other things, newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated. The risks and uncertainties included above are not exhaustive. Other factors that could adversely affect the Company’s business and prospects are described in the Company’s filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such data or statements are based.
Firstbank Corporation (FBMI) Announces Second Quarter 2010 Results
Highlights Include:
- Net income of $937,000 and net income available to common shareholders of $525,000 in the second quarter of 2010, compared to $62,000 net income and a negative earnings available to common of $351,000 for these measures in the second quarter of 2009
- Earnings per share equaled $0.07 for the second quarter of 2010, up from $0.03 per share in the first quarter of 2010 and a loss of $0.04 in the second quarter of 2009
- Provision expense of $3.1 million and net charge-offs of $2.6 million in the second quarter of 2010 decreased from $5.3 million of provision expense and $2.7 million of net charge-offs in the second quarter of 2009
- Ratio of the allowance for loan losses to loans strengthened to 1.90% at June 30, 2010, compared to 1.70% at December 31, 2009, and 1.48% at June 30, 2009
- Loan portfolio continues to shrink due to economic conditions and lack of demand
- Equity ratios remain strong and all affiliate banks continue to exceed all regulatory well-capitalized requirements
ALMA, Mich., July 27, 2010 (GLOBE NEWSWIRE) — Thomas R. Sullivan, President and Chief Executive Officer of Firstbank Corporation (Nasdaq:FBMI – News), announced net income of $937,000 for the second quarter of 2010, compared to $62,000 for the second quarter of 2009, with net income available to common shareholders of $525,000 in the second quarter of 2010 compared to negative $351,000 in the second quarter of 2009. Earnings per share were $0.07 in the second quarter of 2010 compared to a loss of $0.04 in the second quarter of 2009. Returns on average assets and average equity for the second quarter of 2010 were 0.26% and 2.7%, respectively, compared to 0.03% and 0.3% respectively in the second quarter of 2009.
Earnings comparisons to the year-ago quarterly period were impacted by a one-time FDIC insurance assessment expense in the second quarter of 2009. Ongoing FDIC insurance expense, provision expense, and other credit and collection expense continue at elevated levels. Provision expense in the second quarter of 2010 was $3,066,000, up 23.1% from the first quarter of 2010 but 41.9% lower than in the second quarter of 2009. The provision expense of $3,066,000 in the second quarter of 2010 exceeded net charge-offs in the quarter of $2,599,000 as management continued to build the level of reserves for loan losses.
For the first half of 2010, net income of $1,596,000 was 1.3% higher than in the first half of 2009, although net income available to common declined to $771,000 in the first six months of 2010 versus $887,000 for the same period in 2009. Earnings per share were $0.10 in the first half of 2010 compared to $0.12 in the year-ago first half. Provision expense of $5,557,000 in the first half of 2010 exceeded net charge-offs of $4,083,000, and the provision expense was 19% lower than in the first half of 2009.
Expense control efforts continued. Comparing the second quarter of 2010 with the second quarter of 2009, salaries and employee benefits expense decreased 5.4% and occupancy and equipment expense declined 10.5%. The sale of 1st Armored in the first quarter of 2010, while having little impact on net income, also helped to reduce expenses.
Firstbank’s net interest margin was 3.82% in the second quarter of 2010 compared to 3.77% in both the first quarter of 2010 and the second quarter of 2009. Some of Firstbank’s affiliate banks have begun to pay off higher rate Federal Home Loan Bank advances upon their maturities, helping to reduce funding costs. Core deposits have increased, providing a lower cost source of funding. Also, strategies employed during 2009 aimed at incorporating floors on variable rate loans and re-pricing deposits upon renewal at currently competitive rates, have resulted in the improvement in margin. The improvement in margin helped net interest income in the second quarter of 2010 increase 2.8% compared to the first quarter of 2010 and increase 6.8% from the second quarter of 2009.
Mortgage gains, particularly from refinances, were strong in 2009, but both refinance and purchase money mortgage business were very slow in the first quarter of 2010. However, the second quarter of 2010 saw some improvement. Gain on sale of mortgage loans increased to $726,000 in the second quarter of 2010, 96.2% above the level in the first quarter of 2010. In spite of this improvement in the quarter, for the first half of 2010, mortgage gains were 80% lower than in the first half of 2009.
The category of other non-interest income in the second quarter of 2010 showed decreases from both the first quarter of 2010 and from the second quarter of 2009. These decreases are more than explained by the absence of 1st Armored and 1st Title in the consolidated results.
Total assets of Firstbank Corporation at June 30, 2010, were $1.477 billion, an increase of 3.5% over the year-ago period. Total portfolio loans of $1.083 billion were 4.2% below the year-ago level. Commercial and commercial real estate loans decreased 2.5% over this twelve month period, and real estate construction loans decreased 11.2%. Residential mortgage and consumer loans also decreased. The strong mortgage refinance activity in 2009 resulted in loans being financed in the secondary market rather than on the balance sheet of the company. While Firstbank has ample capital and funding resources to increase loans on its balance sheet, demand for funds for new ventures by quality borrowers remains weak due to uncertainty about the economy. Total deposits as of June 30, 2010, were $1.162 billion, compared to $1.056 billion at June 30, 2009, an increase of 10.0%. Core deposits increased $107 million or 10.7% over the year-ago level.
Mr. Sullivan stated, “We continue to focus attention on managing credits and making adjustments in the operations of our company while we wait hopefully for improvement in economic activity. As many businesses and homeowners remain under economic stress, we saw an uptick in net charge-offs in the most recent quarter, although not to an amount above the year-ago level. There continues to be a lack of demand in our markets from borrowers with good credit credentials who are optimistically planning to invest in new projects that have good financial prospects. We continue to have abundant capacity and willingness to make good loans. However, the shrinkage of the loan portfolio results in increased holdings of cash and short term securities with very low investment yields.
“Our efforts to streamline our company by moving out of non-core activities, like title insurance and armored car services, are favorably impacting our expense levels and enabling management to focus on more significant issues. We are also capitalizing on opportunities, related to changes in our business volumes and technology, to reduce personnel and other operating expenses. While recognizing these opportunities, we also are mindful of the importance of our highly capable and motivated staff serving our customers, and our Compensation Committee continues to monitor and adjust compensation programs in accordance with its Compensation Philosophy.
“We continue to have success with our retail strategies and branch network, positioning ourselves well both currently and for the future. Core deposits continue to grow, increasing 0.5% in the second quarter and 10.7% over the past year. Construction is nearly complete on our new branch facility in DeWitt and we are beginning construction on a replacement facility for one of our high volume locations in Mt. Pleasant.”
At June 30, 2010, the ratio of the allowance for loan losses to loans increased to 1.90%, compared to 1.70% at December 31, 2009, and 1.48% at June 30, 2009. The ratio of allowance for loan loss to non-performing loans stood at 55% on June 30, 2010, compared to 47% at December 31, 2009, and 63% at June 30, 2009.
Net charge-offs were $2,599,000 in the second quarter of 2010, higher than the $1,484,000 in the first quarter of 2010, but reduced from the $2,736,000 amount in the second quarter of 2009. In the second quarter of 2010, net charge-offs annualized represented 0.95% of average loans. For the first half of 2010, net charge-offs annualized represented 0.74% of average loans, compared to 0.84% in the first half of 2009. The ratio of non-performing loans (including loans past due over 90 days) to loans stood at 3.43% on June 30, 2010, compared to 3.23% on March 31, 2010 and 3.66% as of December 31, 2009.
Total equity was slightly higher at June 30, 2010, compared to both the levels at December 31, 2009, and June 30, 2009. The ratio of average equity to average assets was 9.8% in both the first and second quarters of 2010, compared to 10.5% in the second quarter of 2009. All of Firstbank Corporation’s affiliate banks continue to meet regulatory well-capitalized requirements.
Firstbank Corporation, headquartered in Alma, Michigan, is a bank holding company using a multi-bank-charter format with assets of $1.5 billion and 51 banking offices serving Michigan’s Lower Peninsula. Bank subsidiaries include: Firstbank – Alma; Firstbank (Mt. Pleasant); Firstbank – West Branch; Firstbank – St. Johns; Keystone Community Bank; and Firstbank – West Michigan.
This press release contains certain forward-looking statements that involve risks and uncertainties. When used in this press release the words “anticipate,” “believe,” “expect,” “hopeful,” “potential,” “should,” and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements concerning future business growth, changes in interest rates, loan charge-off rates, demand for new loans, the performance of restructured loans, and the resolution of problem loans. Such statements are subject to certain risks and uncertainties which could cause actual results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, economic, competitive, governmental and technological factors affecting the Company’s operations, markets, products, services, interest rates and fees for services. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.
FIRSTBANK CORPORATION | ||||||
CONSOLIDATED STATEMENTS OF INCOME | ||||||
(Dollars in thousands except per share data) | ||||||
UNAUDITED | ||||||
Three Months Ended: | Six Months Ended: | |||||
Jun 30 | Mar 31 | Jun 30 | Jun 30 | Jun 30 | ||
2010 | 2010 | 2009 | 2010 | 2009 | ||
Interest income: | ||||||
Interest and fees on loans | $16,993 | $17,021 | $17,504 | $34,014 | $35,128 | |
Investment securities | ||||||
Taxable | 910 | 716 | 648 | 1,626 | 1,394 | |
Exempt from federal income tax | 272 | 309 | 321 | 581 | 653 | |
Short term investments | 50 | 53 | 23 | 103 | 53 | |
Total interest income | 18,225 | 18,099 | 18,496 | 36,324 | 37,228 | |
Interest expense: | ||||||
Deposits | 4,198 | 4,278 | 4,819 | 8,476 | 9,987 | |
Notes payable and other borrowing | 1,359 | 1,497 | 1,821 | 2,856 | 3,784 | |
Total interest expense | 5,557 | 5,775 | 6,640 | 11,332 | 13,771 | |
Net interest income | 12,668 | 12,324 | 11,856 | 24,992 | 23,457 | |
Provision for loan losses | 3,066 | 2,491 | 5,276 | 5,557 | 6,864 | |
Net interest income after provision for loan losses | 9,602 | 9,833 | 6,580 | 19,435 | 16,593 | |
Noninterest income: | ||||||
Gain on sale of mortgage loans | 726 | 370 | 3,109 | 1,096 | 5,482 | |
Service charges on deposit accounts | 1,180 | 1,097 | 1,122 | 2,277 | 2,205 | |
Gain (loss) on trading account securities | 0 | 23 | 16 | 23 | (113) | |
Gain (loss) on sale of AFS securities | (46) | 55 | 357 | 9 | 300 | |
Mortgage servicing | 63 | 126 | (191) | 189 | (543) | |
Other | 442 | 593 | 715 | 1,035 | 994 | |
Total noninterest income | 2,365 | 2,264 | 5,128 | 4,629 | 8,325 | |
Noninterest expense: | ||||||
Salaries and employee benefits | 5,249 | 5,460 | 5,551 | 10,709 | 11,181 | |
Occupancy and equipment | 1,369 | 1,490 | 1,529 | 2,859 | 3,256 | |
Amortization of intangibles | 210 | 210 | 245 | 420 | 490 | |
FDIC insurance premium | 485 | 545 | 1,155 | 1,030 | 1,526 | |
Other | 3,406 | 3,722 | 3,460 | 7,128 | 6,714 | |
Total noninterest expense | 10,719 | 11,427 | 11,940 | 22,146 | 23,167 | |
Income before federal income taxes | 1,248 | 670 | (232) | 1,918 | 1,751 | |
Federal income taxes | 311 | 11 | (294) | 322 | 176 | |
Net Income | 937 | 659 | 62 | 1,596 | 1,575 | |
Preferred Stock Dividends | 412 | 413 | 413 | 825 | 688 | |
Net Income available to Common Shareholders | $525 | $246 | ($351) | $771 | $887 | |
Fully Tax Equivalent Net Interest Income | $12,860 | $12,543 | $12,071 | $25,403 | $23,900 | |
Per Share Data: | ||||||
Basic Earnings | $0.07 | $0.03 | ($0.04) | $0.10 | $0.12 | |
Diluted Earnings | $0.07 | $0.03 | ($0.04) | $0.10 | $0.12 | |
Dividends Paid | $0.01 | $0.05 | $0.10 | $0.06 | $0.20 | |
Performance Ratios: | ||||||
Return on Average Assets (a) | 0.26% | 0.21% | 0.03% | 0.24% | 0.24% | |
Return on Average Equity (a) | 2.7% | 2.2% | 0.3% | 2.4% | 2.5% | |
Net Interest Margin (FTE) (a) | 3.82% | 3.77% | 3.77% | 3.80% | 3.72% | |
Book Value Per Share (b) | $14.86 | $14.73 | $15.02 | $14.86 | $15.02 | |
Average Equity/Average Assets | 9.8% | 9.8% | 10.5% | 9.8% | 9.9% | |
Net Charge-offs | $2,599 | $1,484 | $2,736 | $4,083 | $4,790 | |
Net Charge-offs as a % of Average Loans (c)(a) | 0.95% | 0.54% | 0.96% | 0.74% | 0.84% | |
(a) Annualized | ||||||
(b) Period End | ` | |||||
(c) Total loans less loans held for sale |
FIRSTBANK CORPORATION | |||||
CONSOLIDATED BALANCE SHEETS | |||||
(Dollars in thousands) | |||||
UNAUDITED | |||||
Jun 30 | Mar 31 | Dec 31 | Jun 30 | ||
2010 | 2010 | 2009 | 2009 | ||
ASSETS | |||||
Cash and cash equivalents: | |||||
Cash and due from banks | $25,752 | $22,906 | $27,254 | $39,653 | |
Short term investments | 49,154 | 86,069 | 80,111 | 52,497 | |
Total cash and cash equivalents | 74,906 | 108,975 | 107,365 | 92,150 | |
Securities available for sale | 231,204 | 187,374 | 159,758 | 108,091 | |
Federal Home Loan Bank stock | 9,084 | 9,084 | 9,084 | 9,084 | |
Loans: | |||||
Loans held for sale | 108 | 1,098 | 578 | 2,676 | |
Portfolio loans: | |||||
Commercial | 182,773 | 188,983 | 192,096 | 183,287 | |
Commercial real estate | 381,216 | 388,324 | 397,862 | 395,227 | |
Residential mortgage | 374,901 | 375,000 | 376,683 | 390,318 | |
Real estate construction | 78,694 | 80,018 | 85,229 | 88,668 | |
Consumer | 65,127 | 66,318 | 69,736 | 72,482 | |
Total portfolio loans | 1,082,711 | 1,098,643 | 1,121,607 | 1,129,982 | |
Less allowance for loan losses | (20,588) | (20,121) | (19,114) | (16,668) | |
Net portfolio loans | 1,062,123 | 1,078,522 | 1,102,493 | 1,113,314 | |
Premises and equipment, net | 24,662 | 24,475 | 25,437 | 25,616 | |
Goodwill | 35,513 | 35,513 | 35,513 | 35,513 | |
Other intangibles | 2,520 | 2,730 | 2,940 | 3,384 | |
Other assets | 36,491 | 39,581 | 39,187 | 36,302 | |
TOTAL ASSETS | $1,476,611 | $1,487,352 | $1,482,356 | $1,426,130 | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||
LIABILITIES | |||||
Deposits: | |||||
Noninterest bearing accounts | $164,475 | $155,896 | $164,333 | $165,574 | |
Interest bearing accounts: | |||||
Demand | 261,888 | 262,778 | 255,414 | 226,078 | |
Savings | 197,208 | 190,214 | 174,114 | 162,879 | |
Time | 522,205 | 531,667 | 532,370 | 480,954 | |
Wholesale CD’s | 16,452 | 15,848 | 22,832 | 20,700 | |
Total deposits | 1,162,228 | 1,156,403 | 1,149,063 | 1,056,185 | |
Securities sold under agreements to | |||||
repurchase and overnight borrowings | 36,601 | 43,750 | 39,409 | 44,163 | |
FHLB Advances and notes payable | 85,110 | 94,246 | 100,263 | 127,814 | |
Subordinated Debt | 36,084 | 36,084 | 36,084 | 36,084 | |
Accrued interest and other liabilities | 8,382 | 10,002 | 10,657 | 13,953 | |
Total liabilities | 1,328,405 | 1,340,485 | 1,335,476 | 1,278,199 | |
SHAREHOLDERS’ EQUITY | |||||
Preferred stock; no par value, 300,000 | |||||
shares authorized, 33,000 outstanding | 32,748 | 32,741 | 32,734 | 32,707 | |
Common stock; 20,000,000 shares authorized | 115,034 | 114,907 | 114,773 | 114,253 | |
Retained earnings | (891) | (1,338) | (1,225) | 50 | |
Accumulated other comprehensive income/(loss) | 1,315 | 557 | 598 | 921 | |
Total shareholders’ equity | 148,206 | 146,867 | 146,880 | 147,931 | |
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $1,476,611 | $1,487,352 | $1,482,356 | $1,426,130 | |
Common stock shares issued and outstanding | 7,771,105 | 7,750,159 | 7,730,241 | 7,669,227 | |
Principal Balance of Loans Serviced for Others ($mil) | $599.0 | $597.8 | $602.1 | $575.1 | |
Asset Quality Ratios: | |||||
Non-Performing Loans / Loans (a) | 3.43% | 3.23% | 3.66% | 2.34% | |
Non-Perf. Loans + OREO / Loans (a) + OREO | 4.30% | 3.99% | 4.29% | 3.14% | |
Non-Performing Assets / Total Assets | 3.18% | 2.97% | 3.27% | 2.51% | |
Allowance for Loan Loss as a % of Loans (a) | 1.90% | 1.83% | 1.70% | 1.48% | |
Allowance / Non-Performing Loans | 55% | 57% | 47% | 63% | |
Quarterly Average Balances: | |||||
Total Portfolio Loans (a) | $1,090,129 | $1,108,023 | $1,124,361 | $1,137,106 | |
Total Earning Assets | 1,349,637 | 1,343,224 | 1,318,027 | 1,283,676 | |
Total Shareholders’ Equity | 146,396 | 146,037 | 147,730 | 148,247 | |
Total Assets | 1,487,312 | 1,484,094 | 1,455,351 | 1,417,842 | |
Diluted Shares Outstanding | 7,757,387 | 7,736,621 | 7,712,814 | 7,643,929 | |
(a) Total Loans less loans held for sale |
Onyx Pharmaceuticals (ONXX) Announces Positive Top-Line Carfilzomib Data From Phase 2b Study
EMERYVILLE, Calif., July 26 /PRNewswire-FirstCall/ — Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced positive top-line results from the Phase 2b 003-A1 study of single-agent carfilzomib, a selective, next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. In an independent review of the data, carfilzomib achieved an overall response rate (partial response or greater) of 24 percent and a median duration of response of 7.4 months in patients who entered the study after receiving a median of five prior lines of therapy (corresponding to a median of 13 anti-myeloma agents) and whose disease was refractory to their last therapeutic regimen. The clinical benefit rate (minimal response or greater) in the study population was 36 percent. Carfilzomib was well-tolerated and there were no new or unexpected toxicities observed. Full results of the trial will be presented at an upcoming scientific meeting. Based on these results, Onyx is continuing discussions with the U.S. Food and Drug Administration (FDA) regarding next steps in filing a new drug application (NDA) for carfilzomib, which the company expects to submit by year-end 2010 for potential accelerated approval in the U.S.
“Despite recent advances in treating multiple myeloma, all patients eventually relapse. The unmet medical need remains great, as the outlook for patients with relapsed and refractory disease is grim,” said Michael G. Kauffman, M.D., Ph.D., Chief Medical Officer of Onyx Pharmaceuticals. “According to a study from the International Myeloma Working Group, patients, such as those enrolled in the 003-A1 study, can expect to respond to therapy only 11 percent of the time and survive for only six to 10 months.(i) The single-agent activity with durable disease control and favorable tolerability observed in this study indicate that carfilzomib has the potential to alter the natural course of this deadly disease.”
“Carfilzomib has the potential to be an important therapy in multiple myeloma and exemplifies the Onyx vision to build a leading oncology company by developing innovative targeted therapies,” said N. Anthony Coles, M.D., President and Chief Executive Officer of Onyx Pharmaceuticals. “We are committed to bringing this promising treatment to patients as quickly as possible by pursuing an accelerated approval pathway in the U.S., while simultaneously moving forward with two Phase 3 studies. The first study, ASPIRE, is designed to support full carfilzomib registration in the U.S. in earlier-stage patients who have relapsed following initial lines of therapy, and the second study is designed to support approval in relapsed and refractory patients in Europe.”
Trial Design
The 003-A1 study was an open-label, single-arm Phase 2b trial. The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma whose disease was refractory to their last treatment regimen and who had received at least two prior therapies, including bortezomib, either thalidomide or lenalidomide, an alkylating agent, glucocorticoids and an anthracycline. Refractory disease was defined as < 25% response or progression during therapy or within 60 days after completion of therapy.(ii) Patients enrolled in the 003-A1 trial had received a median of five prior therapeutic regimens, corresponding to a median of 13 anti-myeloma agents. Patients received carfilzomib at 20mg/m2 for the first cycle followed by 27mg/m2 thereafter for up to 12 cycles. Patients who completed the 12 cycles were eligible to enter an extension study. Responses and progression were determined according to the International Myeloma Working Group (IMWG) criteria. The trial was conducted in collaboration with the Multiple Myeloma Research Consortium (MMRC) and at additional sites in the U.S. and Canada.
“The patients in the 003-A1 trial represent an advanced population with significant unmet medical need who had received many lines of therapy and had limited options available to them outside of a clinical trial, strongly underscoring the need for new treatments. We are proud to have worked with the Onyx team that is developing carfilzomib and are encouraged by these results,” said Kathy Giusti, Founder and CEO of the MMRC and a multiple myeloma patient. The MMRC initiated a relationship with the company (then Proteolix) in 2006, which included the participation of 11 MMRC Member Institutions in the 003-A1 trial, representing 36 percent of the total trial centers and 60 percent of enrolled patients.
“There is a high unmet need for treatment options for patients with relapsed and refractory multiple myeloma who are no longer responding to available therapies,” said Brian G.M. Durie, M.D., Cofounder and Chair of the Board of Directors of the International Myeloma Foundation (IMF).
Investor Teleconference
Onyx will host a teleconference and webcast on Monday, July 26, 2010, at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss the top-line data from the Phase 2b 003-A1 study of carfilzomib.
Interested parties may access a live webcast of the presentation on the company’s website at: http://www.onyx-pharm.com/view.cfm/32/Event-Calendar
or by dialing 847-619-6547 and using the passcode 27571112. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 27571112# approximately one hour after the teleconference concludes. The replay will be available through August 9, 2010.
About the Carfilzomib Development Program
Carfilzomib is a selective, next-generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma.
As previously reported at the 46th American Society of Clinical Oncology (ASCO) Annual Meeting, an ongoing, companion Phase 2 study, known as the 004 study, demonstrated encouraging overall response rates, tolerability and durable disease control when carfilzomib was administered as a single-agent in patients with relapsed and/or refractory multiple myeloma. In 53 evaluable patients who had not been previously treated with bortezomib, carfilzomib achieved an overall response rate of 55 percent and a median duration of response of 11.5 months at 27mg/m2. Forty percent of patients were refractory to their most recent therapy prior to entering the trial. In the overall 004 study population, treatment with carfilzomib was well-tolerated, and no new or unexpected adverse events occurred. The most common Grade 3 treatment-emergent adverse events included: pneumonia (11 percent), anemia (9.7 percent), neutropenia (9.7 percent) and thrombocytopenia (9 percent). Peripheral neuropathy of any grade was infrequent, and no Grade 4 adverse events were observed.
The company has also initiated a large randomized international Phase 3 clinical trial, known as the ASPIRE trial, studying the combination of lenalidomide and low dose dexamethasone with or without carfilzomib in patients with relapsed multiple myeloma. The company has an agreement with the U.S. FDA on a Special Protocol Assessment (SPA) and received Scientific Advice from the European Medicines Agency (EMA) on the design and planned analysis for the ASPIRE trial. A second Phase 3 clinical trial, known as the FOCUS trial, is planned to evaluate carfilzomib in patients with advanced myeloma and serve as the basis for a European registration. Carfilzomib is also being studied in advanced solid tumors.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.(iii) Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.(iv)
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of the thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company’s website at www.onyx-pharm.com.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.
Forward Looking Statements
This news release contains “forward-looking statements” of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including the risk that Proteolix’s operations will not be integrated successfully into Onyx’s, the risk that Onyx may not realize the anticipated benefits of the acquisition and risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2009, filed with the Securities and Exchange Commission under the heading “Risk Factors” and Onyx’s Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
(i) Kumar S, Crowley J, Lee J-H, Lahuerta JJ, Morgan G et al. “Outcome of Subjects with Myeloma Relapsing after IMiD and Bortezomib Therapy: A Multicenter Study from the International Myeloma Foundation Working Group. Poster presentation: 15th Congress of the European Hematology Association, June 10-13, 2010, Barcelona, Spain.
(ii) Anderson et al. Clinically relevant end points and new drug approvals for myeloma. Leukemia. 2008. 22:231
(iii) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(iv) International Agency for Research on Cancer, GLOBOCAN 2002 database
SOURCE Onyx Pharmaceuticals, Inc.
Silicom (SILC) Reports Strong Q2 with Significant Growth across All Parameters
KFAR SAVA, Israel–(BUSINESS WIRE)–Silicom Ltd. (NASDAQ:SILC)(TASE:SILC) today reported financial results for the second quarter ended June 30, 2010.
Financial Results
Revenues for the second quarter of 2010 were $6.7 million, an increase of 66% compared with $4.0 million for the second quarter of 2009 and 5% compared with $6.4 million for the first quarter of 2010.
Operating income for the quarter was $1.4 million, a nine-fold increase compared with $152,000 in the second quarter of 2009. Net income for the quarter was $1.4 million, or $0.20 per share (basic and diluted), a five-fold increase compared with $256,000, or $0.04 per share (basic and diluted), for the second quarter of 2009.
For the six-month period, revenues were $13.1 million, a 45% increase compared with $9.1 million for the first half of 2009. Operating income for the first half of 2010 increased by 201% to $2.4 million from $801,000 in the prior-year period, and net income for the period increased by 107% to $2.3 million, or $0.33 per diluted share ($0.34 per basic share) compared with $1.1 million, or $0.16 per diluted share ($0.17 per basic share), for the first half of 2009.
As of June 30, 2010, the Company’s cash, cash equivalents, bank deposits and marketable securities totaled $43.9 million, or $6.44 per outstanding share.
Comments of Management
Commenting on the results, Shaike Orbach, President and CEO, said, “We are very pleased to report another strong quarter for Silicom – a period during which we achieved 66% growth in revenues, 84% increase in gross profit, 822% increase in operating income and 440% increase in net income as compared year-over-year to the second quarter of 2009.
“These satisfying results reflect the IT market’s bottomless need for faster response times and increased bandwidth in an era of cloud computing, virtualization and Internet-based applications, and the industry’s growing awareness of our products and technologies as effective solutions to bottleneck challenges. This reputation, combined with our continued investment in sales, marketing and R&D, is paying off with a steady increase in our sales and profits.”
Mr. Orbach continued, “The positive factors that have been driving our results for the last few quarters make us optimistic regarding our future potential. For our traditional product lines, our growth is being driven in three ways. First, many of our existing customers continue to increase the size of their ongoing orders. Second, some of our larger customers have begun integrating additional Silicom products into their product lines. Third, we continue to add new companies to our customer base, and this expands our platform for ongoing repeat orders. In parallel, we are also seeing the beginning of market traction for our External Bypass Switches, encryption products and Redirector cards, as demonstrated by an increased flow of orders within all of our growth areas.
“As to SETAC, the newest and an exciting part of our strategy, we are increasingly confident regarding the market need as well as our marketing approach. During the quarter, we announced another SETAC win with a very important customer, while also continuing to build out the pipeline of customers who are evaluating and/or considering it for their next generation appliances. The size and depth of this pipeline leads us to believe that the SETAC will succeed in generating significant, growing sales over the long term.”
Mr. Orbach concluded, “Taken as a whole, the results we have achieved so far, the strengthening of the growth factors driving our business and the potential of our new product lines make us feel well-positioned to generate additional growth as we enter the second half of 2010.”
Conference Call Details:
Silicom’s Management will host an interactive conference today, July 26th, at 9am EDT (6am Pacific Time, 4pm Israel Time) to review and discuss the results. To participate, please call one of the following teleconferencing numbers. Please begin placing your calls at least 10 minutes before the conference call commences. If you are unable to connect using the toll-free numbers, try the international dial-in number.
US: 1 888 668 9141
UK: 0 800 917 5108
ISRAEL: 03 918 0609
INTERNATIONAL: +972 3 918 0609
At: 9:00am Eastern Time, 6:00am Pacific Time, 4:00pm Israel Time
For those unable to listen to the live call, a replay of the call will be available for three months from the day after the call under the investor relations section of Silicom’s website, at: www.silicom.co.il
About Silicom
Silicom Ltd. is an industry-leading provider of high-performance server/appliances networking solutions. The Company’s flagship products include a variety of multi-port Gigabit Ethernet, copper and fiber-optic, server adapters and innovative BYPASS adapters designed to increase throughput and availability of server-based systems, WAN Optimization and security appliances and other mission-critical gateway applications. For more information, please visit: www.silicom.co.il.
Statements in this press release which are not historical data are forward-looking statements which involve known and unknown risks, uncertainties, or other factors not under the Company’s control, which may cause actual results, performance, or achievements of the Company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not limited to, those detailed in the Company’s periodic filings with the Securities and Exchange Commission. The Company disclaims any duty to update such statements.
— FINANCIAL TABLES FOLLOW —
Silicom Ltd. Consolidated Balance Sheets
|
|||||
(US$ thousands)
|
|||||
June 30,
|
December 31,
|
||||
2010
|
2009
|
||||
Assets
|
|||||
Current assets | |||||
Cash and cash equivalents | $7,487 | $7,253 | |||
Short-term bank deposits | 8,639 | 7,253 | |||
Marketable securities | 11,722 | 10,425 | |||
Accounts receivables: Trade, net | 5,175 | 5,172 | |||
Accounts receivables: Other | 574 | 371 | |||
Inventories | 7,472 | 4,677 | |||
Deferred tax assets | 92 | 233 | |||
Total current assets | 41,161 | 35,384 | |||
Marketable securities | 16,041 | 18,308 | |||
Assets held for employees’ severance benefits |
1,096
|
1,105
|
|||
Deferred tax assets | 227 | 192 | |||
Property, plant and equipment, net | 563 | 602 | |||
Total assets | $59,088 | $55,591 | |||
Liabilities and shareholder’s equity | |||||
Current liabilities
|
|||||
Trade accounts payable | $3,705 | $2,261 | |||
Other accounts payable and accrued expenses |
1,737
|
2,138
|
|||
Total current liabilities
|
5,442 | 4,399 | |||
Liability for employees’ severance benefits
|
1,973
|
1,967
|
|||
Total liabilities
|
7,415 | 6,366 | |||
Shareholders’ equity
|
|||||
Ordinary shares and additional paid-in capital |
34,301
|
34,174
|
|||
Treasury shares | (38) | (38) | |||
Retained earnings | 17,410 | 15,089 | |||
Total Shareholders’ equity
|
51,673 | 49,225 | |||
Total liabilities and shareholders equity
|
$59,088
|
$55,591
|
|||
Silicom Ltd. Consolidated
|
|||||||||
Statements of Income
|
|||||||||
(US$ thousands, except for share and per share data)
|
|||||||||
Three-month period | Six-month period | ||||||||
ended June 30, | ended June 30, | ||||||||
2010 | 2009 | 2010 | 2009 | ||||||
Sales | $6,739 | $4,048 | $13,139 | $9,066 | |||||
Cost of sales | 3,778 | 2,438 | 7,476 | 5,516 | |||||
Gross profit | 2,961 | 1,610 | 5,663 | 3,550 | |||||
Research and development expenses | 693 | 698 | 1,530 | 1,335 | |||||
Selling and marketing expenses | 495 | 443 | 993 | 822 | |||||
General and administrative expenses | 372 | 317 | 732 | 592 | |||||
Total operating expenses | 1,560 | 1,458 | 3,255 | 2,749 | |||||
Operating income | 1,401 | 152 | 2,408 | 801 | |||||
Financial income, net | 225 | 192 | 366 | 536 | |||||
Income before income taxes | 1,626 | 344 | 2,774 | 1,337 | |||||
Income taxes | 243 | 88 | 453 | 214 | |||||
Net income | $1,383 | $256 | $2,321 | $1,123 | |||||
Basic income per ordinary share
|
$0.20
|
$0.04
|
$0.34
|
$0.17
|
|||||
Weighted average number of ordinary
shares used to compute basic income per share (in thousands) |
6,810 | 6,696 | 6,810 | 6,695 | |||||
Diluted income per ordinary share
|
$0.20
|
$0.04
|
$0.33
|
$0.16
|
|||||
Weighted average number of ordinary
shares used to compute diluted income per share (in thousands) |
6,957 | 6,840 | 6,961 | 6,818 |
Astrotech (ASTC) Subsidiary Secures $9.5 Million NASA Contract
AUSTIN, Texas, July 26, 2010 (GLOBE NEWSWIRE) — Astrotech Corporation (Nasdaq:ASTC – News), a leading provider of commercial aerospace services, today announced that NASA awarded its Astrotech Space Operations business unit a new contract for payload processing services for expendable launch vehicles (ELVs) and evolved expendable launch vehicles (EELVs) from Cape Canaveral Air Force Station (CCAFS) at the Eastern Range in Florida.
“We look forward to continuing our relationship with NASA in support of missions at the Eastern Range,” stated Astrotech Chairman and Chief Executive Officer Thomas B. Pickens III. “We are proud of our capabilities and facilities, and look forward to providing NASA with a full complement of processing and facility services.”
With a value not to exceed $9.5 million, this indefinite-delivery, indefinite-quantity (IDIQ) contract is for payload processing support on several upcoming NASA spacecraft missions. The contract stipulates that the multi-mission contract services are targeted to begin in fiscal year 2011 running through 2013.
From Titusville, Florida, Vandenberg Air Force Base, California and the Sea Launch Home Port facilities in Long Beach, California, Astrotech Space Operations provides all support necessary for government and commercial customers to successfully process their satellite hardware for launch, including advance planning; use of unique facilities; and spacecraft checkout, encapsulation, fueling, and transport. In its 25 year history, Astrotech has supported the processing of more than 280 spacecraft without impacting a customer’s launch schedule.
About Astrotech Corporation
Astrotech Corporation (Nasdaq:ASTC – News) is a commercial aerospace company that provides spacecraft payload processing and government services, designs and manufactures space hardware, and commercializes space technologies for use on Earth. The Company serves our government and commercial satellite and spacecraft customers with our pre-launch services from our Astrotech Space Operations (ASO) subsidiary and incubates space technology businesses now focusing on two companies: 1st Detect Corporation, which is developing a mini-mass spectrometer first developed for the International Space Station; and Astrogenetix, Inc., which is developing biotech products in space and has recently developed a vaccine candidate for Salmonella.
The Astrotech Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7456
The statements in this document may contain forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, continued government support and funding for key space programs, product performance and market acceptance of products and services, as well as other risk factors and business considerations described in the company’s Securities & Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. The Company assumes no obligation to update these forward-looking statements.
NetSol (NTWK) Signs Contract to Implement NFS CAP Solution with a Major U.S. Auto Manufacturer in China
CALABASAS, Calif., July 26, 2010 (GLOBE NEWSWIRE) — NetSol Technologies, Inc. (“NetSol” or “Company”) (Nasdaq:NTWK) (Nasdaq Dubai:NTWK), a U.S. corporation providing global business services and enterprise application solutions to private and public sector organizations worldwide, today announced that the Company was awarded a major software and IT services contract valued at over $1 million with a major U.S. automotive manufacturer’s captive finance arm in China. Under the terms of the contract, the Company will provide its Credit Application Processing solution to fully automate point of sale (POS) functions in the client’s Chinese dealer network. NetSol will install its next-generation platform to capture all credit and client data at the point of sale to streamline and automate the entire credit application capture process.
Naeem Ghauri, President and Head of Global Sales at NetSol, commented: “This is a major win for NetSol’s China operations. Our state-of-the-art auto leasing platform has become the de facto gold standard in the Chinese IT market. This new win clearly establishes NFS as a market leader with over 90% IT market share in China’s captive auto finance sector. We expect to sign a number of new deals in the foreseeable future, as our pipeline remains strong and growing.”
China overtook the U.S. in 2009 to become the world’s largest auto market, with over 13 million vehicles sold during the year. Research firm J.D. Power and Associates projects that sales of passenger vehicles (a category that includes passenger cars, SUVs and minivans) in China will increase from 8.7 million vehicles in 2009 to 13.5 million vehicles by 2015, an increase of more than 55%.
Credit Application Processing (CAP), a component of the NetSol Financial Suite (NFSTM) of products, is a web-based credit evaluation system. CAP provides finance and leasing companies with the ability to quickly assess the merit and risk level of an applicant applying for a loan or a lease. The system is seamlessly integrated with NetSol’s POS module, but it can also be customized to link to any third-party point of sale system.
About NetSol Technologies, Inc.
NetSol Technologies, Inc. (Nasdaq:NTWK) (Nasdaq Dubai:NTWK) is a worldwide provider of global IT and enterprise application solutions. Since its inception in 1995, NetSol has used its BestShoring™ practices and highly experienced resources in analysis, development, quality assurance, and implementation to deliver high-quality, cost-effective solutions. Specialized by industry, these product and services offerings include credit and finance portfolio management systems, SAP consulting and services, custom development, systems integration, and technical services for the global Financial, Leasing, Insurance, Energy, and Technology markets. NetSol’s commitment to quality is demonstrated by its achievement of the ISO 9001, ISO 27001, and SEI (Software Engineering Institute) CMMI (Capability Maturity Model) Maturity Level 5 assessments, a distinction shared by fewer than 100 companies worldwide. NetSol Technologies’ clients include Fortune 500 manufacturers, global automakers, financial institutions, utilities, technology providers, and government agencies. Headquartered in Calabasas, California, NetSol Technologies has operations and offices in Alameda, Adelaide, Bangkok, Beijing, Karachi, Lahore, London, and Riyadh.
To learn more about NetSol, visit http://www.netsoltech.com.
The NetSol Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7396
NetSol Technologies, Inc. Forward-looking Statements
This press release may contain forward-looking statements relating to the development of the Company’s products and services and future operation results, including statements regarding the Company that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “anticipate,” “intend,” variations of such words, and similar expressions, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Factors that could affect the Company’s actual results include the progress and costs of the development of products and services and the timing of the market acceptance. The subject Companies expressly disclaim any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based.
SearchMedia (IDI) Launches New Corporate Website
SHANGHAI, CHINA–(Marketwire – 07/23/10) – SearchMedia Holdings Limited (“SearchMedia” or the “Company”) (AMEX:IDI – News) (AMEX:IDI.WS – News), one of China’s leading nationwide multi-platform media companies, today announced that it has re-launched its corporate website at www.searchmediaholdings.com.
Speaking about the updated website, Paul Conway, Chief Executive Officer of SearchMedia, said, “Our new corporate website has been updated to highlight the services SearchMedia provides and to exhibit the range of our media networks. Searchmediaholdings.com now further highlights our advertising capabilities in the outdoor billboard, transit and in-elevator platforms across our nationwide network.”
About SearchMedia
SearchMedia is a leading nationwide multi-platform media company and one of the largest operators of integrated outdoor billboard and in-elevator advertising networks in China. SearchMedia currently operates a network of approximately 1,500 high-impact billboards with over 500,000 square feet of surface display area and one of China’s largest networks of in-elevator advertisement panels consisting of approximately 125,000 frames in 50 cities throughout China. Additionally, SearchMedia operates a network of large-format light boxes in concourses of eleven major subway lines in Shanghai. SearchMedia’s core outdoor billboard and in-elevator platforms are complemented by its subway advertising platform, which together enable it to provide a multi-platform, “one-stop shop” services for its local, national and international advertising clients. For more information about SearchMedia, please visit www.searchmediaholdings.com
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts, including statements about SearchMedia’s beliefs and expectations, may constitute forward-looking statements as that term is defined by the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expect,” “anticipate,” “future,” “intend,” “plan,” “believe,” “estimate,” “confident” and similar statements. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to: the Company’s ability to achieve long-term profitable growth; that potential acquisition and growth opportunities may not materialize or may not be completed; that extended contracts with management of certain of the Company’s operating subsidiaries may not provide the anticipated benefits or long-term relationships; and the risks that there are uncertainties and matters beyond the control of management, and other risks outlined in the Company’s filings with the U.S. Securities and Exchange Commission. SearchMedia cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. SearchMedia does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based.
Momenta Pharmaceuticals (MNTA) Announces FDA Approval for First Generic Lovenox(R)
CAMBRIDGE, Mass., July 23, 2010 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA – News), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration has granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection filed by Sandoz. Developed under a collaboration agreement between Momenta and Sandoz, this product has been designated therapeutically equivalent to the reference-listed drug, Lovenox(R), which is marketed by Sanofi-Aventis.
“The approval of M-Enoxaparin marks a key milestone for Momenta, and we are extremely pleased,” commented Craig Wheeler, President and CEO. “This is the first product based on Momenta’s technology platform to be approved, and demonstrates our ability to characterize and develop a complex mixture drug like Lovenox.”
The Company is aware that other ANDAs for enoxaparin sodium injection have been filed. These other applicants may receive approval at a later date.
Conference Call Information
Management will host a conference call on July 23, 2010 at 1:00 pm ET. Call details to follow separately.
About Momenta
Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs.
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.
Forward Looking Statements
Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, including our beliefs regarding the potential commercial market for enoxaparin sodium injection, usp, may constitute 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, 2010 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 obligation 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.
Lovenox (R) is a registered trademark of Sanofi-Aventis.
NxStage (NXTM) Reports Record Second Quarter 2010 Financial Results and Raises Revenue Guidance For 2010
LAWRENCE, Mass., July 23 /PRNewswire-FirstCall/ — NxStage Medical, Inc. (Nasdaq:NXTM – News), a leading manufacturer of innovative dialysis products, today reported record financial results for the second quarter of 2010 ended June 30, 2010, with total revenue above the top end of its guidance range.
Net revenue for the second quarter of 2010 increased to $44.0 million, an increase of 21 percent when compared with revenue of $36.4 million for the second quarter of 2009. The increase was driven by strong performance across the Company’s three markets: Home, Critical Care and In-Center.
The Company delivered its third straight quarter of record sequential growth in its Home market with revenue of $20.8 million for the second quarter of 2010, representing an increase of 37 percent when compared with revenue of $15.2 million for the second quarter of 2009. Critical Care revenue grew to $6.7 million for the second quarter of 2010, representing an increase of 27 percent when compared with revenues of $5.2 million for the second quarter of 2009. Revenue in the In-Center market, from the Company’s Medisystems business, increased to $16.5 million for the second quarter of 2010.
“Q2 was another great quarter in all respects: we delivered record revenue with all three of our markets outperforming, and Home delivering the strongest growth; achieved positive cash flow; and, continued operational execution across all our markets,” stated Jeffrey H. Burbank, Chief Executive Officer of NxStage Medical. “With a strong first half of the year and continuing momentum, we are increasing our projections for sequential growth in Home and raising our revenue guidance for 2010 to a range of revenues between $170 and $175 million.”
NxStage reported a net loss of $8.3 million, or ($0.17) per share, for the second quarter of 2010 compared with a net loss of $12.5 million, or ($0.27) for the second quarter of 2009.
For the second quarter of 2010, NxStage increased gross margins to 31%, a sequential increase of 200 basis points, and achieved positive cash flow of $1.0 million. The Company had an Adjusted EBITDA loss of $0.2 million, adjusted for stock-based compensation, deferred revenue recognized and other non-recurring expenses, for the second quarter of 2010, compared with an Adjusted EBITDA loss of $3.4 million in the second quarter of 2009. (See the exhibits for a reconciliation of this non-GAAP measure.)
NxStage also announced an amended and restated National Service Provider Agreement with DaVita Inc, the leading home hemodialysis service provider. This Agreement covers the use of NxStage’s products for home hemodialysis in the United States, and is intended to support the continued and collaborative expansion of patient access to home hemodialysis therapy with the System One.
“DaVita has made substantial investments in building its home hemodialysis capabilities over recent years under our previous Agreement, and I believe we have much that we can accomplish as partners in the coming years,” continued Mr. Burbank. “The Agreement includes a performance-based rebate payable in warrants. This is an elegant structure for achieving significant performance targets. To earn value, DaVita has to significantly increase patient access to NxStage home hemodialysis, and our share price must simultaneously increase. We are delighted to have created a unique relationship structure that can create value for both of our businesses as we collaborate to expand patient access to this life-changing therapy.”
Guidance:
For the third quarter of 2010, the Company is forecasting revenue to be within a range of $43 to $45 million. At this revenue level, the Company would expect a net loss in the range of $7.5 to $8.5 million or ($0.15) to ($0.18) per share, and Adjusted EBITDA in the range of $0 to $0.5 million for the third quarter of 2010.
Supported by its strong performance in the first half of 2010, the Company now anticipates revenue for the 2010 fiscal year to be in a range of $170 to $175 million, compared with its prior guidance for revenues to be in a range of $163 to $170 million. The Company is maintaining its guidance for a net loss in the range of $28 to $33 million or ($0.60) to ($0.71) per share, and for Adjusted EBITDA to be in the range of a positive $1 million to a loss of $3.0 million for the 2010 fiscal year. The Company expects to achieve consolidated gross margins of between 33 percent to 37 percent in the fourth quarter of 2010.
This release contains a non-GAAP financial measure. A reconciliation of the Company’s non-GAAP financial measure to its most comparable GAAP financial measure is in the exhibits to this press release.
Conference Call:
NxStage will also host a conference call today at 9:00 a.m. Eastern Time to discuss its second quarter financial results and its new agreement with DaVita. To listen to the conference call, please 800-573-4840 (domestic) or 617-224-4326 (international). The passcode is 72236162. The call will also be webcast LIVE and can be accessed via the investor relations section of the Company’s website at www.nxstage.com/ir.cfm.
A replay of the conference call will be available 3 hours after the start of the call through August 6, 2010. To access the replay dial 888-286-8010 (domestic) or 617-801-6888 (international) and enter passcode 86233006. An online archive of the conference call can be accessed via the investor relations section of the Company’s website at www.nxstage.com/ir.cfm.
About NxStage
NxStage Medical, Inc. (Nasdaq:NXTM – News) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the company’s website at www.nxstage.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “plan,” and similar expressions are generally intended to identify forward-looking statements. Examples of these forward-looking statements include statements as to the anticipated demand for the Company’s products, anticipated operating results, including revenues, loss, gross margin and Adjusted EBITDA numbers, expectations regarding achievement of improved cash flow, and other expectations as to future operating results. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond NxStage’s control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance or achievements, including market acceptance and demand for NxStage’s products, growth in home and/or daily hemodialysis, unanticipated difficulties in achieving operational efficiencies and cost reductions, changes in reimbursement for home and daily hemodialysis, changes in the regulatory environment, changes in the historical purchasing patterns and preferences of our major customers, including DaVita Inc., and certain other factors that may affect future operating results and which are detailed in NxStage’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2010.
In addition, the statements in this press release represent NxStage’s expectations and beliefs as of the date of this press release. NxStage anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while NxStage may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events, or otherwise. These forward-looking statements should not be relied upon as representing NxStage’s expectations or beliefs as of any date subsequent to the date of this press release.
Contact: | |
Kristen K. Sheppard, Esq. | |
VP, Investor Relations | |
ksheppard@nxstage.com | |
Non-GAAP Financial Measure
The Company discloses a certain non-GAAP financial measure to supplement the Company’s consolidated financial statements presented on a GAAP basis. This non-GAAP measure is not in accordance with, or an alternative for, generally accepted accounting principles in the United States and may be different from similar non-GAAP financial measures used by other companies. The non-GAAP financial measure disclosed by the Company is not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. Management uses Adjusted EBITDA (EBITDA adjusted for stock based-compensation, deferred revenue recognized, and other non-recurring expenses) to understand operational cash usage. The Company believes the non-GAAP financial measure provides useful and supplementary information allowing investors greater transparency to one measure used by management. The non-GAAP financial measure is meant to supplement, and to be viewed in conjunction with, GAAP financial measures. The non-GAAP financial measure is reconciled to the most comparable GAAP financial measure below.
NxStage Medical, Inc. |
||||||||
Condensed Consolidated Statements of Operations |
||||||||
(in thousands, except per share data) |
||||||||
(unaudited) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
June 30, |
June 30, |
|||||||
2010 |
2009 |
2010 |
2009 |
|||||
Revenues |
$44,008 |
$ 36,398 |
$ 84,416 |
$ 70,133 |
||||
Cost of revenues |
30,246 |
27,581 |
58,841 |
54,261 |
||||
Gross profit |
13,762 |
8,817 |
25,575 |
15,872 |
||||
Operating expenses: | ||||||||
Selling and marketing |
8,565 |
7,411 |
16,582 |
14,642 |
||||
Research and development |
3,202 |
2,271 |
6,237 |
4,673 |
||||
Distribution |
3,632 |
3,525 |
7,043 |
7,209 |
||||
General and administrative |
5,643 |
4,749 |
10,581 |
9,704 |
||||
Total operating expenses |
21,042 |
17,956 |
40,443 |
36,228 |
||||
Loss from operations |
(7,280) |
(9,139) |
(14,868) |
(20,356) |
||||
Other expense: | ||||||||
Interest income |
– |
14 |
– |
25 |
||||
Interest expense |
(1,148) |
(3,337) |
(2,256) |
(4,372) |
||||
Other income (expense), net |
330 |
(14) |
213 |
79 |
||||
(818) |
(3,337) |
(2,043) |
(4,268) |
|||||
Net loss before income taxes |
(8,098) |
(12,476) |
(16,911) |
(24,624) |
||||
Provision for income taxes |
158 |
39 |
344 |
119 |
||||
Net loss |
$ (8,256) |
$(12,515) |
$(17,255) |
$(24,743) |
||||
Net loss per share, basic and diluted |
$ (0.17) |
$ (0.27) |
$ (0.37) |
$ (0.53) |
||||
Weighted-average shares outstanding, basic and diluted |
47,492 |
46,575 |
47,228 |
46,565 |
||||
NxStage Medical, Inc. |
|||||
Condensed Consolidated Balance Sheets |
|||||
(amount in thousands, except share data) |
|||||
(unaudited) |
|||||
June 30, |
December 31, |
||||
2010 |
2009 |
||||
ASSETS | |||||
Current assets: |
|||||
Cash and cash equivalents |
$ 20,045 |
$ 21,720 |
|||
Accounts receivable, net |
14,769 |
14,238 |
|||
Inventory |
30,889 |
28,117 |
|||
Prepaid expenses and other current assets |
1,888 |
1,227 |
|||
Total current assets |
67,591 |
65,302 |
|||
Property and equipment, net |
8,633 |
10,336 |
|||
Field equipment, net |
17,340 |
21,726 |
|||
Deferred cost of revenues |
33,760 |
27,799 |
|||
Intangible assets, net |
26,810 |
28,208 |
|||
Goodwill |
42,698 |
42,698 |
|||
Other assets |
550 |
909 |
|||
Total assets |
$197,382 |
$ 196,978 |
|||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
Current liabilities: |
|||||
Accounts payable |
$ 18,868 |
$ 19,827 |
|||
Accrued expenses |
11,695 |
9,377 |
|||
Current portion of long-term debt |
53 |
61 |
|||
Total current liabilities |
30,616 |
29,265 |
|||
Deferred revenue |
47,234 |
38,490 |
|||
Long-term debt |
39,123 |
37,854 |
|||
Other long-term liabilities |
1,763 |
1,923 |
|||
Total liabilities |
118,736 |
107,532 |
|||
Commitments and contingencies |
|||||
Stockholders’ equity: |
|||||
Undesignated preferred stock: par value $0.001, 5,000,000 shares authorized; no shares issued and outstanding, as of June 30, 2010 and December 31, 2009 |
– |
– |
|||
Common stock: par value $0.001, 100,000,000 shares authorized; 48,731,290 shares issued as of June 30, 2010 and 46,795,859 shares issued and outstanding as of December 31, 2009 |
48 |
47 |
|||
Additional paid-in capital |
374,320 |
365,548 |
|||
Accumulated deficit |
(293,969) |
(276,714) |
|||
Accumulated other comprehensive income |
(12) |
565 |
|||
Treasury stock, at cost: 174,757 shares as of June 30, 2010 |
(1,741) |
– |
|||
Total stockholders’ equity |
78,646 |
89,446 |
|||
Total liabilities and stockholders’ equity |
$197,382 |
$ 196,978 |
|||
NxStage Medical, Inc. |
||||
Cash Flows from Operating Activities |
||||
(amounts in thousands) |
||||
(unaudited) |
||||
Six Months Ended |
||||
June 30, |
||||
2010 |
2009 |
|||
Cash flows from operating activities: | ||||
Net loss |
$ (17,255) |
$ (24,743) |
||
Adjustments to reconcile net loss to net | ||||
cash used in operating activities: | ||||
Depreciation and amortization |
11,077 |
10,229 |
||
Stock-based compensation |
6,875 |
3,877 |
||
Other |
1,128 |
1,197 |
||
Changes in operating assets and liabilities: |
||||
Accounts receivable |
(527) |
2,494 |
||
Inventory |
(13,327) |
(2,179) |
||
Prepaid expenses and other assets |
(404) |
700 |
||
Accounts payable |
(399) |
(2,788) |
||
Accrued expenses and other liabilities |
3,060 |
(144) |
||
Deferred revenue |
8,745 |
672 |
||
Net cash used in operating activities |
$ (1,027) |
$ (10,685) |
||
NxStage Medical, Inc. |
||||||||
Revenues by Segment |
||||||||
(in thousands) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
June 30, |
June 30, |
|||||||
2010 |
2009 |
2010 |
2009 |
|||||
System One segment | ||||||||
Home |
$ 20,815 |
$ 15,205 |
$ 39,858 |
$ 29,559 |
||||
Critical Care |
6,652 |
5,241 |
12,711 |
9,709 |
||||
Total System One segment |
27,467 |
20,446 |
52,569 |
39,268 |
||||
In-Center segment |
16,541 |
15,952 |
31,847 |
30,865 |
||||
Total |
$ 44,008 |
$ 36,398 |
$ 84,416 |
$ 70,133 |
||||
NxStage Medical, Inc. Non-GAAP Financial Measures (amounts in millions) (unaudited) |
||||||||
Three Months Ended |
Six Months Ended |
|||||||
June 30, |
June 30, |
|||||||
2010 |
2009 |
2010 |
2009 |
|||||
Net loss |
$ (8.3) |
$ (12.5) |
$ (17.3) |
$ (24.7) |
||||
Less: Depreciation amortization, interest, and taxes |
6.5 |
8.4 |
13.4 |
14.6 |
||||
Less: Adjusting items* |
1.6 |
0.7 |
2.4 |
1.1 |
||||
Adjusted EBITDA gain (loss) |
$ (0.2) |
$ (3.4) |
$ (1.5) |
$ (9.0) |
||||
* Adjusting items include stock-based compensation, deferred revenue recognized and other non-recurring expenses |
||||||||
NxStage Medical, Inc. |
||||
Non-GAAP Financial Guidance |
||||
(amounts in millions) |
||||
Three Months Ended |
||||
September 30, 2010 |
||||
High |
Low |
|||
Net loss |
$ (7.5) |
$ (8.5) |
||
Less: Depreciation amortization, interest, and taxes |
6.5 |
6.5 |
||
Less: Adjusting items* |
1.5 |
2.0 |
||
Adjusted EBITDA gain (loss) |
$ 0.5 |
$ – |
||
* Adjusting items include stock-based compensation, deferred revenue recognized and other non-recurring expenses |
Sterling Infosystems (INTX) Acquires Screening International
NEW YORK, July 22 /PRNewswire/ — Sterling Infosystems, Inc., a leading provider of employment and background screening services, announced that it has acquired Screening International, LLC from Intersections Inc. (Nasdaq:INTX – News) a leading providing of consumer and corporate identity risk management services.
Screening International serves over 1,700 clients ranging from Fortune 100 companies to small business enterprises, operating as American Background Information Services in the US, and as Aperion Screening internationally.
“This acquisition allows us to expand our client base in the United States and Europe, and introduce our industry-leading products, services and technology to new markets,” said Bill Greenblatt, CEO of Sterling Infosystems Inc. “For over 25 years, Screening International has provided services that enhance the safety, security and efficiency of the workplace, and we are proud to announce this transaction to our current and future clients.”
Key employees of Screening International, including its President, Scott Smith, will continue to provide their expertise and services to its existing clients. “Our clients can expect the same level of high quality service from our new company, a seamless transition, and enhanced risk management services that will offer tremendous new benefits,” said Smith.
About Sterling
Sterling Infosystems, Inc. (www.sterlinginfosystems.com) is a leading New York-based technology firm providing employment and student screening services, corporate due diligence and background investigation services, occupational health services, and employment related business tax consulting services in the United States and 200 countries around the world. More than 7,500 companies trust Sterling to provide them with high quality, reliable data on which they base hiring, continued employment and admission decisions. With offices in most major cities in the U.S., Sterling’s clients range from leading Fortune 500 firms to small and medium sized businesses. Sterling’s industry-leading CourtDirect technology allows it to provide services faster, better and more cost effectively than other providers.
About Intersections (www.intersections.com)
Intersections Inc. (NASDAQ:INTX – News) is a leading provider of consumer and corporate identity risk management services. Its premier identity theft, privacy, and consumer solutions are designed to provide high-value opportunities to its marketing partners, including leading financial institutions, Fortune 100 corporations, and other businesses. Intersections also markets full identity theft protection solutions under its brand, IDENTITY GUARD® (www.identityguard.com). Intersections’ consumer identity theft protection services have protected more than 30 million consumers.
Syntel (SYNT) Reports Second Quarter 2010 Financial Results
Highlights:
- Q2 revenue of $130.6M, up 31% from year-ago quarter and 13% percent sequentially
- Q2 EPS of $0.68 per diluted share, up 11% from year-ago quarter and up 13% sequentially
- Q2 cash & short term investments of $221.5M
- Global Headcount of 14,926 as of June 30, 2010
TROY, Mich., July 22, 2010 (GLOBE NEWSWIRE) — Syntel, Inc. (Nasdaq:SYNT – News), a global information technology services and Knowledge Process Outsourcing (KPO) firm, today announced financial results for the second quarter, ended June 30, 2010.
Second Quarter Financial Highlights
Syntel’s revenue for the second quarter increased 31 percent to $130.6 million, compared to $100.1 million in the prior-year period, and increased 13 percent sequentially from $116.0 million in the first quarter of 2010. Revenue growth was broad-based across both verticals and IT service offerings. During the second quarter, Applications Outsourcing accounted for 76 percent of total revenue, with Knowledge Process Outsourcing (KPO) at 14 percent, e-Business contributing seven percent and TeamSourcing at three percent.
The Company’s gross margin was 39.5 percent in the second quarter, compared to 48.2 percent in the prior-year period and 42.4 percent in the first quarter of 2010. Selling, General and Administrative (SG&A) expenses were 14.6 percent in the second quarter, compared to 20.8 percent in the prior-year period and 19.2 percent in the previous quarter. Syntel’s income from operations was 24.8 percent in the second quarter as compared to 27.4 percent in the prior-year period and 23.3 percent in the first quarter of 2010.
Syntel’s gross and operating margins in the second quarter were pressured by the impact of offshore wage increases and the renegotiation of a large client contract. SG&A expenses were reduced by $1.7M during the quarter and $3.6M sequentially due to exchange rate variations.
Net income for the second quarter was $28.3 million or $0.68 per diluted share, compared to $25.1 million or $0.61 per diluted share in the prior-year period and net income of $25.1 million or $0.60 per diluted share in the first quarter of 2010.
Operational Highlights
“Syntel’s second quarter financial results highlight the improving demand environment for offshore services and Syntel’s ability to add value to our clients,” said Syntel CEO and President Prashant Ranade. “Demand for cost reduction services continued to be robust during the quarter, and revenue momentum was accelerated by increased spending for strategic development initiatives.”
“During the second quarter, Syntel was pleased to announce that we were able to finalize negotiations regarding our KPO joint venture,” said Ranade. “From a demand standpoint, our pipeline is extremely healthy and the opportunity for new business expansion is robust. As a result, Syntel added over 1,200 employees in Q2. In preparation for continued growth, we also celebrated the inauguration of our new campus in Chennai during the quarter. The Company remains focused on the long-term business opportunity, and will continue to invest in new services, depth and breadth of skills and world-class infrastructure.”
2010 Guidance
Based on current visibility levels and an exchange rate assumption of 46.5 rupees to the dollar, the Company currently expects 2010 revenue of $510 to $522 million and EPS in the range of $2.50 to $2.60.
Syntel to Host Conference Call
Syntel will discuss its second quarter 2010 results today on a conference call at 10:00 a.m. (Eastern). To listen to the call, please dial (877) 665-2445 in the US/Canada or (408) 427-3788 internationally. The call will also be broadcast live via the Internet at Syntel’s web site: investor.syntelinc.com. Please access the site at least 15 minutes prior to the call to register and download any necessary software. A replay will be available until July 29, 2010 by dialing (800) 642-1687 and entering “88460450”. International callers may dial (706) 645-9291 and enter the same passcode.
About Syntel
Syntel (Nasdaq:SYNT – News) is a leading global provider of integrated information technology and Knowledge Process Outsourcing (KPO) solutions spanning the entire lifecycle of business and information systems and processes. The Company is driven by its mission to create new opportunities for clients by harnessing the passion, talent and innovation of Syntel employees worldwide. Syntel leverages dedicated Centers of Excellence, a flexible Global Delivery Model, and a strong track record of building collaborative client partnerships to create sustainable business advantage for Global 2000 organizations. Recently named one of the “50 Best Managed Global Outsourcing Vendors” by The Black Book of Outsourcing, Syntel is assessed at SEI CMMi Level 5, and is ISO 27001 and ISO 9001:2000 certified. As of June 30, 2010, Syntel employed more than 14,900 people worldwide. To learn more, visit us at: www.syntelinc.com.
Safe Harbor Provision
This news release includes forward-looking statements, including those with respect to the future level of business for Syntel, Inc. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements as a result of certain risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2009 and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010.
SYNTEL, INC. AND SUBSIDIARIES | |||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||
(IN THOUSANDS, EXCEPT SHARE DATA) | |||||
THREE MONTHS ENDED | SIX MONTHS ENDED | ||||
JUNE 30, | JUNE 30, | ||||
2010 | 2009 | 2010 | 2009 | ||
Net revenues | $ 130,649 | $ 100,102 | $ 246,688 | $ 196,536 | |
Cost of revenues | 79,083 | 51,846 | 145,883 | 103,408 | |
Gross profit | 51,566 | 48,256 | 100,805 | 93,128 | |
Selling, general and administrative expenses | 19,114 | 20,845 | 41,362 | 39,569 | |
Income from operations | 32,452 | 27,411 | 59,443 | 53,559 | |
Other income, principally interest, net | 1,959 | 2,325 | 4,242 | 3,310 | |
Income before provision for income taxes | 34,411 | 29,736 | 63,685 | 56,869 | |
Income tax expense | 6,151 | 4,624 | 10,294 | 4,408 | |
Net income | $ 28,260 | $ 25,112 | $ 53,391 | $ 52,461 | |
Dividend per share | $ 0.06 | $ 0.06 | $ 0.12 | $ 0.12 | |
EARNINGS PER SHARE: | |||||
Basic | $ 0.68 | $ 0.61 | $ 1.29 | $ 1.27 | |
Diluted | $ 0.68 | $ 0.61 | $ 1.28 | $ 1.27 | |
Weighted average common shares outstanding: | |||||
Basic | 41,508 | 41,379 | 41,495 | 41,367 | |
Diluted | 41,580 | 41,479 | 41,573 | 41,457 | |
SYNTEL, INC. AND SUBSIDIARIES | |||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||||||
(IN THOUSANDS) | |||||||||||||||||
June 30, 2010 | December 31, 2009 | ||||||||||||||||
ASSETS | |||||||||||||||||
Current assets: | |||||||||||||||||
Cash and cash equivalents | $ 92,000 | $ 87,822 | |||||||||||||||
Short term investments | 129,479 | 112,243 | |||||||||||||||
Accounts receivable, net of allowance for doubtful accounts of $2,998 and $3,000 at June 30, 2010 and December 31, 2009, respectively | 67,311 | 48,523 | |||||||||||||||
Revenue earned in excess of billings | 13,762 | 5,809 | |||||||||||||||
Deferred income taxes and other current assets | 29,730 | 23,739 | |||||||||||||||
Total current assets | 332,282 | 278,136 | |||||||||||||||
Property and equipment | 153,410 | 143,911 | |||||||||||||||
Less accumulated depreciation and amortization | 59,942 | 54,271 | |||||||||||||||
Property and equipment, net | 93,468 | 89,640 | |||||||||||||||
Goodwill | 906 | 906 | |||||||||||||||
Non current Term Deposits with Banks | 21,474 | 23,337 | |||||||||||||||
Deferred income taxes and other non current assets | 23,405 | 20,603 | |||||||||||||||
$ 471,535 | $ 412,622 | ||||||||||||||||
LIABILITIES | |||||||||||||||||
Current liabilities: | |||||||||||||||||
Accrued payroll and related costs | $ 28,929 | $ 26,240 | |||||||||||||||
Income taxes payable | 3,200 | 777 | |||||||||||||||
Accounts payable and other current liabilities | 26,166 | 21,139 | |||||||||||||||
Deferred revenue | 5,657 | 5,888 | |||||||||||||||
Total current liabilities | 63,952 | 54,044 | |||||||||||||||
Other non current liabilities | 9,749 | 8,540 | |||||||||||||||
Total liabilities | 73,701 | 62,584 | |||||||||||||||
SHAREHOLDERS’ EQUITY | |||||||||||||||||
Total shareholders’ equity | 397,834 | 350,038 | |||||||||||||||
Total liabilities and shareholders’ equity | $ 471,535 | $ 412,622 |
Cleveland Biolabs’ (CBLI) CBLB502 for Reducing the Risk of Death Following Total Body Irradiation During or After a Radiation Disaster
BUFFALO, NY–(Marketwire – 07/22/10) – Cleveland BioLabs, Inc. (NASDAQ:CBLI – News) today announced that CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS), has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).
The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review, which may result in an abbreviated review time of six months.
“We are extremely pleased that the lead indication for CBLB502 has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program’s review process,” said Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs.
About CBLB502
CBLB502 is a derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines.
CBLB502 is being developed by Cleveland BioLabs under the FDA’s Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human volunteers.
Evidence of CBLB502’s mechanism of action and activity in animal models was published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp. 226-230). Data from 50 human subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. Dosing of 100 subjects in a second human safety study for CBLB502 was completed in May. Analysis of safety and biomarker data from this study is ongoing. There is currently no FDA approved medical countermeasure to reduce the risk of death following total body irradiation.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the company’s website at http://www.cbiolabs.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s periodic filings with the Securities and Exchange Commission.
DayStar (DSTI) is Pursuing Offshore Manufacturing of its CIGS Solar Modules
NEWARK, Calif., July 22 /PRNewswire-FirstCall/ — DayStar Technologies, Inc. (Nasdaq:DSTI – News), a developer of solar photovoltaic products based on CIGS thin-film deposition technology announced today it is pursuing a strategy for offshore manufacturing of its CIGS solar modules.
DayStar CEO, Magnus Ryde, commented, “While DayStar has accomplished significant innovations with our CIGS process and technology, we have encountered challenges in obtaining affordable capital for the build-out and operation of our facility in Newark, California. At this time, we are pursuing opportunities to manufacture our CIGS modules offshore and have begun discussions with several potential partners to implement this strategy. We are encouraged by the high caliber of the potential partners we are in discussions with. They understand the commercial potential for our CIGS modules and they bring substantial manufacturing and financial capabilities to the table. Those potential partnerships, if consummated, could include joint ventures, licensing agreements, contract manufacturing agreements, a reverse merger with or an acquisition of DayStar. We are confident in our core proprietary CIGS technology and believe that completing a transaction with a strategic partner and manufacturing our CIGS modules offshore would provide the best opportunity to bring our product to market and to manufacture the product in the most cost effective manner.”
Mr. Ryde added, “In addition to the potential partnership discussions mentioned above, we disclosed on May 3, 2010 that DayStar entered into an agreement with Dynamic Worldwide Solar Energy LLC (‘Dynamic’) to provide DayStar with a series of loan commitments and at least one fully funded 25MW solar energy project. Under the terms of that agreement, Dynamic has proposed to assign to DayStar its interest in a fully financed contract to fabricate, construct and install, and commence the operation of, a 25 MW solar energy generation plant. We are actively working with Dynamic on these projects. If consummated, these projects will add a new ‘downstream’ dimension to DayStar and allow us to become a fully integrated solar energy company. DayStar’s acceptance of the assignments is subject to applicable due diligence.”
As disclosed in a Form 8-K filing last night with the SEC, DayStar was notified by its landlord, BMR-Gateway Boulevard LLC that the Company’s lease for the premises located at 7333-7373 Gateway Boulevard in Newark, California has been terminated.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release regarding DayStar’s business that are not historical facts may be considered “forward-looking statements.” The forward-looking statements in this news release, including statements regarding potential partnerships, are based on information available at the time the statements are made and/or management’s belief as of that time with respect to future events and involve substantial risks and uncertainties that could cause actual results and outcomes to be materially different. Forward-looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause DayStar’s results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties are detailed in DayStar’s annual report on Form 10-K for the year ended December 31, 2009, and other filings made with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. DayStar undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Royale (ROYL) Makes Two New Discoveries
SAN DIEGO, July 22 /PRNewswire-FirstCall/ — Royale Energy, Inc. (Nasdaq:ROYL – News) today announced that it has successfully drilled the North East Parks #1. The discovery of gas in the two most recent wells brings the year-to-date drilling to six, compared to five in all of 2009.
(Logo: http://photos.prnewswire.com/prnh/20040913/ROYLLOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20040913/ROYLLOGO)
The North East Parks #1 in the LoneStar field, and the Victor Ranch 3-9 in the East Rice Creek field, represent important advances in the ongoing development of these key areas. The completion of the Victor Ranch 3-9 resulted in producible gas from one of the 3 drilled zones. Completion of the North East Parks #1 will commence immediately following the on-going testing of the Victor Ranch 3-9.
Royale plans to drill at least six more natural gas wells in California this year.
Production from Victor Ranch 3-9 and North East Parks #1 is expected to begin in August, contributing to 3rd quarter revenue. The previously drilled Vann #1 and Goddard 1-7 began selling gas on June 21st and April 16th respectively.
“This success demonstrates our commitment to onshore development of clean burning natural gas,” said Stephen Hosmer, the company’s Co-CEO. “We are encouraged that the improving financial condition of the company and the economy allows us to expand our drilling plans and look forward to further growth and positive earnings.”
About the Company
Headquartered in San Diego, Royale Energy, Inc. is an independent energy company. The company is focused on development, acquisition, exploration, and production of natural gas and oil in California, Texas and the Rocky Mountains. It has been a leading independent producer of oil and natural gas for over 20 years. The company’s strength is continually reaffirmed by investors who participate in funding over 50% of the company’s new projects. Additional information about Royale Energy, Inc. is available on its web site at www.royl.com.
Forward Looking Statements
In addition to historical information contained herein, this news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, subject to various risks and uncertainties that could cause the company’s actual results to differ materially from those in the “forward-looking” statements. While the company believes its forward looking statements are based upon reasonable assumptions, there are factors that are difficult to predict and that are influenced by economic and other conditions beyond the company’s control. Investors are directed to consider such risks and other uncertainties discussed in documents filed by the company with the Securities and Exchange Commission.
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