Archive for April, 2017

$NBEV Acquires Coco-Libre

Enables New Age Beverages to penetrate the fast growing coconut water segment Delivers on New Age group’s portfolio strategy in healthy functional beverages Brings important additional revenue and profit scale to New Age Beverages Corporation

DENVER, CO–(Apr 3, 2017) – New Age Beverages Corporation (NASDAQ: NBEV), the Colorado-based company that markets the brands XingTea®, XingEnergy®, Aspen Pure® PH and Aspen Pure® Probiotic Water, Búcha® Live Kombucha, Marley One Drop® Coffee, and Marley Mellow Mood® Relaxation Drinks, today announced the acquisition of Maverick Brands, LLC and its flagship coconut water beverages line Coco-Libre®. The acquisition fills an important gap to complete the Company’s functional beverages portfolio, brings in a top 5 and the number one multi-serve brand in the category, and provides an excellent organic coconut water source for some of the Company’s planned new products.

New Age Beverages Corporation successfully completed a $17.5 million financing and up-listing to the NASDAQ Capital Market Exchange in February. One of the major drivers of growth that the company shared with investors was the potential addition of new brands/companies to act as an accelerant and solidify the Company’s position as a leader in healthy functional beverages. The acquisition of Coco-Libre® is a reflection of New Ages’s strategy taking hold, provides a tremendous value creation and instantly accretive opportunity for shareholders, provides an important organic coconut water sourcing platform for some of New Age’s planned new products, and brings a leading brand into the New Age brand portfolio.

THE TRANSACTION
The transaction includes a combination of cash and shares of common stock in New Age Beverages in return for 100% of the assets and interests of Maverick Brands, LLC and their portfolio of products within the Coco-Libre® franchise. Specific terms of the deal were not disclosed, with the final closing of the transaction subject to certain closing conditions.

Maverick Brands CEO Candace Crawford, commented, “This evolution provides Coco-Libre® with the necessary resources to fund and scale the next phase of growth. We couldn’t be more excited for Coco-Libre® to join the New Age Beverages family.” Crawford, who previously led the sale of ZICO Beverages to The Coca-Cola Company, joined Maverick Brands in February 2015 with a mandate to expand distribution and category innovation. In that time, she oversaw a brand and packaging relaunch, formulation and launch of the category’s first sparkling line, launch of the award-winning Protein line, and growth of the business to become a leader in the category. Crawford continued, “Coco-Libre® is now well positioned to build on its momentum through the New Age Beverage’s supply chain, manufacturing and national DSD network, and we believe Coco-Libre® will thrive in the New Age system.”

THE NEW AGE BEVERAGES CORPORATION
With the addition of Coco-Libre®, New Age will now compete in the following growth segments with organic or all natural, no preservative, no high fructose corn syrup, no GMOs, healthier beverages including:

  • RTD Tea – XingTea®
  • Kombucha – Búcha® Live Kombucha
  • Functional Waters – Aspen Pure® PH, Aspen Pure® Probiotic
  • Energy Drinks – XingEnergy®
  • RTD Coffee – Marley One Drop®
  • Relaxation Drinks – Marley Mellow Mood®
  • Coconut Water – Coco Libre®

Each of the brands have unique competitive points of difference in their respective segments, bound under the New Age umbrella as healthier alternatives with superior functional benefits for consumers.

SYNERGIES

As part of the combination, the team has identified more than $5 million in cost and revenue synergies to be gained over the next 12 months. A convergence committee has been established that has already begun work on identified areas of savings and growth. In the cost synergy area, the group will realize more than $3 million in immediate savings in operating expenses and infrastructure convergence.

Brent Willis, Chief Executive Officer for New Age Beverages and a former senior executive with AB InBev and The Coca-Cola Company commented, “Candace and the Maverick Brands organization did an incredible job in building Coco-Libre® to a top five and the number one multi-serve brand in the category. They led the category with innovation and built a truly differentiated brand in the space. Now with New Age’s resources, infrastructure and capabilities, we expect to help Coco-Libre® grow to its full potential.”

About New Age Beverages Corporation (NASDAQ: NBEV)
New Age Beverages Corporation is a Colorado-based, leading all-natural tea and healthy functional beverage company that was founded in 2003. The Company competes in the fast growing healthy functional beverage segments including Ready to Drink (RTD) Tea, RTD Coffee, Kombucha, Energy Drinks, Relaxation Drinks, Coconut Waters and Functional Waters with the brands XingTea®, Marley One Drop®, Búcha® Live Kombucha, XingEnergy®, Marley Mellow Mood®, Coco-Libre®, and Aspen Pure® PH and Aspen Pure® Probiotic Water. The Company’s brands are sold across all 50 states within the US and in more than 10 countries internationally across all channels via direct and store door distribution systems. The company operates the websites www.newagebev.us, www.mybucha.com, www.xingtea.com, www.aspenpure.com, www.drinkmarley.com, and www.cocolibre.com

Safe Harbor Disclosure
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management’s current expectations regarding future results of operations, economic performance, financial condition and achievements of the Company including statements regarding New Age Beverage’s expectation to see continued growth. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable but there is no assurance that they will prove to be accurate. Forward-looking statements, specifically those concerning future performance are subject to certain risks and uncertainties, and actual results may differ materially. New Age Beverages competes in a rapidly growing and transforming industry, and other factors disclosed in the Company’s filings with the Securities and Exchange Commission might affect the Company’s operations. Unless required by applicable law, New Age Beverages undertakes no obligation to update or revise any forward-looking statements.

Websites: www.newagebev.us
www.mybucha.com
www.xingtea.com
www.aspenpure.com
www.drinkmarley.com
www.cocolibre.com

For investor inquiries about New Age Beverages Corporation please contact:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com

Monday, April 3rd, 2017 Uncategorized Comments Off on $NBEV Acquires Coco-Libre

$GNUS Issues Shareholder Letter

BEVERLY HILLS, CA–(April 03, 2017) – Genius Brands International (NASDAQ: GNUS) recently released a letter to shareholders from Chairman & CEO Andy Heyward. The complete letter follows:

Dear Genius Shareholders,

Our stock has been down lately, and a number of people have asked me what’s going on? The answer I have is the same as what Warren Buffett has both told me personally and has often said publicly.

The stock market goes up, and it goes down. It’s not always logical, nor is it predictable. Good CEOs keep their eye focused on growing their business, not the stock price, and ultimately, investors will be rewarded as the stock price aligns with the business.

With that in mind, I want to share with you today that I see the fundamentals at Genius Brands stronger than at any time in the company’s history. The path to value creation is moving forward with clarity. These facts are underscored by the business highlights and management commentary (below), which was released concurrently with the Company’s annual 10K this last Friday. I’m going to amplify upon this today.

Additionally,

1. Beginning this quarter, we will be scheduling quarterly earning conference calls to give the investment community financial guidance and foundational metrics that can be used to come up with relevant financial models and projections. These calls, and the numbers therein, will make the Genius Brands story easier to understand and track. It is something that we have not been able to provide previously, as we had heretofore been building assets and laying the foundations of our catalogue, a task which would not yet facilitate visibility going forward.

2. We will begin showing an enhanced presence, through either myself, and/or our CFO, and/or our worldwide head of sales, at the small cap investor conferences, the first of which I will be attending and presenting at in New York this week.

3. We have hired PMBC Group, a PR company, independent of our current entertainment industry PR people, to specifically address the business press for the financial and investment community.

The purpose of these 3 actions will be to more effectively get our story out.

In our 2017 fiscal year, we anticipate that we will be able to recognize substantial revenues as we meet GAAP requirements for revenue recognition for several of our properties. Let me highlight some key facts about our various properties and the status of each in that regard. First, by the end of the year, we anticipate that we will have delivered our Llama Llama series to Netflix which will trigger substantial revenue recognition related to the Netflix license. Next, we expect to recognize a significant portion of revenues from our $2 million advance from Sony for fees to be earned against digital and physical home entertainment distribution rights. Additionally, SpacePOP continues to build as a brand with not only more licensing and merchandising advances globally but also more international content licenses across multiple territories for which we anticipate we will be able to recognize additional revenue. Lastly, Rainbow Rangers has a significant toy deal with Mattel, and we will shortly announce a completed broadcast deal with a major broadcaster. We anticipate that those Rainbow Rangers agreements will generate cash collections for the company in 2017 (to be recorded as deferred revenue in fiscal 2017) with revenue recognition anticipated for 2018. Combined, we anticipate that top-line revenue in 2017 will be substantially greater than in recent years, and over the coming quarters, we will begin providing guidance towards that.

  • Deferred revenue (a measure of cash and future revenues) increased by over 220% in FY 2016
  • To date $2.5 million has been invested in the development and production of animated content
  • We are in production and development of four animated series to be delivered throughout 2017 and 2018
  • Currently have over 50 worldwide licensees with over 500 SKUs in over 10,000 retail locations
  • Licensed content to over 20 broadcasters in nearly 90 territories globally as well as several VOD and online platforms
  • We have currently 415 animated episodes in our catalogue and have a robust pipeline of new programs and brands being added. Catalogue is the backbone of value.
  • Kid Genius Cartoon Channel generated first advertising sales in the fourth quarter 2016, and on track to reach over 80 million US TV Households this year. That is a phenomenal statement of value which is underscored by sales of other childrens program services, even the least of which, is many times the current market cap of the complete Genius Brands company.
  • Expanded our long term strategic partnership with our shareholder Sony Pictures Home Entertainment from a domestic to a global partnership in January 2017

The metrics which I encourage our investors to look at today are not revenue and earnings. They are:

# of brands and episodes created

# of subscribers to the channel

# of licensees and SKUs contracted

# pedigree of management and creatives

Earnings are preceded by the value creation. Value creation is what is occurring currently.

To amplify further, more of our children’s brands are in, and now coming into the market, than ever. Eight, to be precise. (SpacePOP, Thomas Edison’s Secret Lab, Llama Llama, Rainbow Rangers, Baby Genius, Warren Buffett’s Secret Millionaires Club, Stan Lee’s Cosmic Crusaders, *project x not yet announced )

  • We continue to have substantial undrawn credit facility at Bank Leumi, further to our Llama Llama production for Netflix.
  • We have large and meaningful contracts for millions of dollars with quality companies like Netflix, Mattel, and others.

In addition to the above, we are amidst concluding two very substantial broadcast deals, both of which will have an immediate impact on 2017 cash and deferred revenue, in addition to the Llama Lama series, scheduled to be delivered to NETFLIX in October, triggering revenue recognition upon delivery.

Amidst all of the aforementioned, the fundamental premise of Genius Brands’ business should not be forgotten. We make animated cartoons and we license consumer products based on our characters. In addition, we operate a programming service of kids content, the Kid Genius Cartoon Channel. In simplistic terms, this model (absent theme parks and resorts, ESPN and ABC local affiliate stations) has been the core of the Walt Disney Company for many years.

  • Making cartoons
  • Licensing consumer products based on the characters of those cartoons
  • Operating a kid programming service which promotes those cartoons (Disney Channel)

The Walt Disney company was founded in 1923. It didn’t make its first feature film SNOW WHITE AND THE SEVEN DWARFS until 1937, went public in 1940, and notoriously struggled, with zero earnings, and cash troubles, as it continued to build assets, eventually finding relief when it reissued Snow White in 1944. Notwithstanding this, the company continued to invest in producing more product and build its catalogue, struggling until 1954, when ABC made an investment which would help relieve pressure.

TODAY, THE WALT DISNEY COMPANY HAS A $179 BILLION DOLLAR MARKET CAP.

This short history illustrates a very important and relevant point. Animated assets are not created instantly, but once they have been produced, and a catalogue has been built, they can spawn enormous and enduring value.

I have been saying for 3 years it takes 3 years for the cycle of asset creation in animation production. We have a laddered portfolio which BEGAN asset creation 3 years ago. We have a 415 episode catalogue and we have a fully functioning channel which is growing extremely rapidly. We are way ahead of where Disney was after 3 years. We are way ahead of where DreamWorks was after 3 years, a company which was eventually sold for over $3 billion dollars. We are ahead of where Marvel was after 3 years, a company which was eventually sold for over $4 billion dollars.

During these last 3 years, we have created a global infrastructure with clients/partners of the best companies in the kids entertainment media/licensing/retail business, including:

  • Netflix
  • Sony
  • Comcast
  • YouTube
  • Mattel
  • Toys R Us
  • Target
  • Kohl’s
  • Claire’s
  • Penguin Publishing

These are the leaders in their field. They play to win. They are cautious and deliberate with whom they enter into business. As are we.

The tactics of value creation of Genius Brands, are fully on track.

Our first fully distributed property, SpacePOP, has proven to be a hit, with both viewership and sales continuing to grow, as we maintain shelf space and grow market share. We are writing contracts for new licensing categories and for foreign distribution.

We continue to hold market share at Toys R Us, Claires, and Kohls. Moreover, adding additional retailers, including Target and Calendar Club, among others, coming on board for Back to School and Fall, 2017. As the SpacePOP brand continues to hold market space at retail, we expect the advances we have been paid by licensees, to be “earned out”, and to become revenues flowing to the company across our various licensee categories, as well as from the international sales, as we will go into our second Christmas season this year.

It might be a good time to remind our investing base, that our management team we have put together is second to none. It is highly pedigreed, coming almost exclusively from the Walt Disney Company, MGM, and Hasbro Toys. Our creative team is also second to none, largely coming out of Disney, and has been responsible for some of the biggest and most successful billion dollar kids brands ever created. Our sales team is second to none, coming out of Hasbro, and has been associated with one success after another after another. These are facts underscored by their historical pedigrees.

NOW, the focus is going to become getting out there and doing a better job at telling our story so the investment community can more fully understand and appreciate the business, so our stock will reflect, what our company is accomplishing.

This remains an exciting time for Genius Brands, and one where we are poised for powerful growth and value recognition.

Andy Heyward

Chairman & CEO

Genius Brands International, Inc.

Investor Relations
Porter, LeVay and Rose
Michael Porter
T: 212-564-4700
Email contact

Monday, April 3rd, 2017 Uncategorized Comments Off on $GNUS Issues Shareholder Letter

$APOP Receives Notice of Intention to Grant from European Patent Office

Patent to provide coverage in both U.S. and EU

Method of treatment patent provides protection in diabetes, inflammatory bowel disease, graft-versus-host disease and transplant rejection

TEL AVIV, Israel, April 03, 2017 — Cellect Biotechnology Ltd. (Nasdaq:APOP), (TASE:APOP), a developer of stem cell isolation technology, announced today that it has received a formal notice of Intention to Grant for a patent (Application No. 11751949.6-1466) covering a key method of treatment from the European Patent Office. The allowed claims relate to the engineering of regulatory immune cells with enhanced apoptotic activity to be used for immunomodulation in treating or preventing immune-related disorders.

Earlier this year, Cellect received a Notice of Allowance from the U.S. Patent & Trademark Office for the same patent.

The patent is expected to protect Cellect’s technology and method when used to treat multiple medical conditions with significant unmet needs, such as diabetes, inflammatory bowel disease, graft-versus-host disease and transplant rejection. The patent covers a segment of cell-based therapeutics that is separate from the one Cellect is currently working in, is relevant to the fast-growing class of immune therapies and Cellect believes may create an opportunity to enhance Cellect’s pipeline.

Shai Yarkoni, Cellect’s CEO, commented, “Now covering both the U.S. and the EU, this patent is a base for the future commercialization of our global business. Cellect has seven families of patents and patent applications to protect its core assets for enabling stem cell regenerative medicine. With this patent, Cellect has the opportunity to diversify its pipeline and open up new commercialization routes for additional market segments.”

About Cellect Biotechnology Ltd.

Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ: “APOP”, “APOPW”, TASE: “APOP”). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue, a technology that aims to improve a variety of stem cells applications.

The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stem cells related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.

Forward Looking Statements          
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss our expectation that the allowed patent will be issued in the EU and in the U.S., that, if approved, the patent will protect Cellect’s technology and method when used to treat multiple medical conditions with significant unmet needs, such as diabetes, inflammatory bowel disease, graft-versus-host disease and transplant rejection, that the patent may create an opportunity to enhance Cellect’s pipeline, may serve as a base for the potential future commercialization of Cellect’s global business and may provide an opportunity to diversify Cellect’s pipeline and potentially open up new commercialization routes for additional market segments and that Cellect’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stem cells related treatments and procedures. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov and in the Company’s period filings with the SEC and the Tel-Aviv Stock Exchange.

Contact
Cellect Biotechnology Ltd. 
Eyal Leibovitz, Chief Financial Officer
www.cellectbio.com
+ 972-9-974-1444

LifeSci Advisors
Bob Yedid, Managing Director
646-597-6989
bob@lifesciadvisors.com
Monday, April 3rd, 2017 Uncategorized Comments Off on $APOP Receives Notice of Intention to Grant from European Patent Office

$RESN Expands Licensing Agreement with Existing Customer

Extension Covers the Design of Resonant’s Fifth Quadplexer for the Chinese Market

Resonant Inc. (NASDAQ: RESN), a designer of filters for radio frequency front-ends, or RFFE, that specializes in delivering designs for difficult bands and complex requirements, today announced it has signed an extension to a licensing agreement with an existing customer, a leading RFFE component vendor.

The expanded agreement encompasses the development of Resonant’s fifth quadplexer, and second for this customer. Upfront payments and milestone payments have been agreed upon, but will not be disclosed due to the confidential nature of such agreements.

“This extension to our licensing agreement with an RFFE supplier requiring a stable supply of high performance filters, continues to validate our competitive advantage,” said George Holmes, CEO of Resonant Inc. “Quadplexers enable carrier aggregation (CA), where multiple frequency bands are combined for higher data rates – a key feature of LTE-Advanced mobile phones. However, the design complexity for these multiplexers has dramatically increased, which has so far limited quadplexer availability. Quadplexers in a small footprint are being driven by the ongoing demand for smaller, lighter and thinner mobile devices with increasing video and other high data-rate capabilities. As our collaboration with this customer evolves, we look forward to pursuing additional opportunities.”

About Resonant Inc.

Resonant is creating software tools and IP & licensable blocks that enable the development of innovative filter designs for the RF front-end, or RFFE, for the mobile device industry. The RFFE is the circuitry in a mobile device responsible for the radio frequency signal processing and is located between the device’s antenna and its digital baseband. Filters are a critical component of the RFFE that selects the desired radio frequency signals and rejects unwanted signals and noise. For more information, please visit www.resonant.com.

About Resonant’s ISN® Technology

Resonant can create designs for difficult bands and complex requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. The Company’s large suite of proprietary mathematical methods, software design tools and network synthesis techniques enable it to explore a much bigger set of possible solutions and quickly derive the better ones. These improved filters still use existing manufacturing methods (i.e. surface acoustic wave (SAW) and/or temperature compensated surface acoustic wave (TC-SAW))) and can perform as well as those using higher cost methods (i.e. BAW or FBAR). While most of the industry designs filters using a coupling-of-modes model, Resonant uses circuit models and physical models. Circuit models are computationally much faster, and physical models are highly accurate models based entirely on fundamental material properties and dimensions. Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is eased because its models speak the “fab language” of basic material properties and dimensions.

Safe Harbor/ Forward-Looking Statements

This press release contains forward-looking statements, which include the following subjects, among others: the status of filter designs under development and the capabilities of our filter designs. Forward-looking statements are made as of the date of this document and are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: our limited operating history; our ability to complete designs that meet customer specifications; the ability of our customers (or their manufacturers) to fabricate our designs in commercial quantities; the ability of our designs to significantly lower costs compared to other designs and solutions; the risk that the intense competition and rapid technological change in our industry renders our designs less useful or obsolete; our ability to find, recruit and retain the highly skilled personnel required for our design process in sufficient numbers to support our growth; our ability to manage growth; and general market, economic and business conditions. Additional factors that could cause actual results to differ materially from those anticipated by our forward-looking statements are under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Annual Report (Form 10-K) or Quarterly Report (Form 10-Q) filed with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.

 

MZ North America
Greg Falesnik, 1-949-385-6449
Greg.Falesnik@mzgroup.us

Monday, April 3rd, 2017 Uncategorized Comments Off on $RESN Expands Licensing Agreement with Existing Customer

$PRTK Positive #Phase3 Study of #Omadacyclin in Pneumoniae

  • Omadacycline met all FDA primary and secondary endpoints and EMA co-primary endpoints
  • Omadacycline was generally safe and well tolerated
  • U.S. New Drug Application planned as early as Q1 2018
  • Company to host a webcast and conference call for investors at 4:30 PM ET to review top-line results

BOSTON, April 03, 2017 — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today positive top-line results from a global, pivotal Phase 3 clinical study comparing its once-daily oral and IV, broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP).  This study represents the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“This successful study demonstrates the potential of omadacycline to treat community-acquired bacterial pneumonia, a significant and serious health issue,” said Michael Bigham, Chairman and Chief Executive Officer at Paratek. “This Phase 3 study in pneumonia along with our previously announced successful Phase 3 study in skin infections satisfy the regulatory filing requirements of our special protocol assessment with the FDA. We look forward to sharing these data with the FDA and EMA. Our plan is to submit our NDA in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.”

Study Results
The global, pivotal Phase 3 clinical study known as OPTIC (Omadacycline for Pneumonia Treatment in the Community), compared the safety and efficacy of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with CABP.  In the study, 774 patients were randomized.  Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority (NI) in the intent-to-treat (ITT) population (10% NI margin, 95% confidence interval) compared to moxifloxacin at the early clinical response (ECR) 72-120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively.

Additionally, the FDA-specified secondary endpoints evaluated omadacycline at the post treatment evaluation (PTE) visit 5-10 days after the completion of therapy in both the ITT population (87.6% for omadacycline vs. 85.1% for moxifloxacin) and in the clinically evaluable (CE) population (92.9% for omadacycline vs. 90.4% for moxifloxacin) as determined by investigators. The secondary endpoints also achieved statistical non-inferiority.

The co-primary endpoints for the EMA were non-inferiority in the ITT and CE CABP populations in those patients with Pneumonia Severity Index (PORT) III and IV at the PTE time point. Omadacycline demonstrated a high response rate and met statistical non-inferiority to moxifloxacin for both populations using a prespecified 97.5% confidence interval. High success rates were observed with response rates of 88.4% (omadacycline) vs. 85.2% (moxifloxacin) and 92.5% (omadacycline) vs. 90.5% (moxifloxacin), respectively.

“We now have experience with omadacycline in more than 1,500 patients in our clinical program and we are very pleased with the safety, tolerability, and efficacy profile that we have seen to date,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer at Paratek.  “We are deeply indebted to the patients, investigators, and entire Paratek team for their commitment to advancing omadacycline. We are delighted to have achieved this significant milestone for the program and the company as we work to bring omadacycline to patients.”

In the study, omadacycline was generally safe and well tolerated, consistent with prior studies of omadacycline. The most common treatment emergent adverse events (TEAEs) in omadacycline-treated patients (occurring in > 3% of patients) were ALT increase (3.7% with omadacycline vs. 4.6% with moxifloxacin) and hypertension (3.4% with omadacycline vs. 2.8% with moxifloxacin).  Gastrointestinal adverse events of interest for omadacycline vs. moxifloxacin included: vomiting (2.6% vs. 1.5%), nausea (2.4% vs. 5.4%), and diarrhea (1.0% vs. 8.0%), respectively. There were no cases of clostridium difficile colitis or infection in patients treated with omadacycline, compared with seven cases (1.8%) in patients treated with moxifloxacin.

Rates of TEAEs were 41.1% for omadacycline vs. 48.5% for moxifloxacin. Drug-related TEAEs were 10.2% for omadacycline vs. 17.8% for moxifloxacin. Discontinuation for TEAEs was uncommon, 5.5% for omadacycline vs. 7.0% for moxifloxacin. Serious TEAEs occurred in 6.0% of omadacycline patients and 6.7% of moxifloxacin patients; four of these were considered related to study drug, two for omadacycline and two for moxifloxacin. The mortality rate was 2.1% with omadacycline and 1.0% with moxifloxacin. Drug-related serious TEAEs leading to premature discontinuation of test article were 2.6% with omadacycline and 2.8% with moxifloxacin.

“Community-acquired bacterial pneumonia results in approximately 3.3 million hospitalizations in the United States each year with a significant mortality risk of more than 5 percent seen in observational studies, putting a significant burden on the healthcare system,” said Dr. Thomas M. File Jr., M.D., MS, Chair of the Infectious Disease Section, Northeast Ohio Medical University, and Chair of the Infectious Disease Division, Summa Health. “Antibiotic resistance is a national issue as susceptibility rates have decreased across most antibiotics since 2010, underscoring the need for new, effective therapies. The positive top-line results of omadacycline in community-acquired bacterial pneumonia is welcome news.”

Results of this study will be submitted for presentation at an upcoming scientific congress.

Conference Call and Web Cast
The company will host a webcast and conference call for investors at 4:30 pm ET today. The live webcast can be accessed under “Events and Presentations” in the Investor Relations section of Paratek’s website at www.paratekpharma.com. The webcast can also be accessed at this link http://public.viavid.com/index.php?id=123672. The webcast will be available for one year.

Domestic callers wishing to participate in the call should dial 877-407-9039 and international callers should dial 201-689-8470. Replays of the call will be available until April 17. Using the same conference ID, replays can be accessed by domestic callers by dialing 844-512-2921. International callers should dial 412-317-6671. The replay PIN is 13659016.

About the OPTIC Study Design
The OPTIC study was a double-blind, active-controlled, global, multi-center study that enrolled 774 adult subjects with moderate to moderately severe CABP and included approximately 14% PORT Class II, 57% PORT Class III, and 28% PORT Class IV.  Patients initially received IV administration of either 100 mg of omadacycline or 400 mg of moxifloxacin. Study investigators were permitted to switch patients to oral dosing of their assigned drug (300 mg once daily omadacycline or 400 mg once daily moxifloxacin) for a total of 7 to 14 days based on assessment of clinical stability.

About Omadacycline
Omadacycline is a once-daily oral and IV, well-tolerated broad spectrum investigational antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.  Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications.

About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek’s lead product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria.  In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy, general safety, and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Top line data from this study are expected as early as the end of June. A Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016.  The company plans to begin enrolling patients in a proof-of-concept Phase 2 study in complicated UTI as early as December of 2017.

In October 2016, Paratek announced a new cooperative research effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance. These studies are designed to confirm dosing regimens and assess efficacy of omadacycline against biodefense pathogens, including Yersinia pestis (plague) and Bacillus anthracis (anthrax).

Paratek’s second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting.  Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017 and Allergan plans to submit a New Drug Application with the U.S. Food and Drug Administration in the second half of this year.

For more information, visit www.paratekpharma.com.

Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and of our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline for the treatment of CABP. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “advancing,” “believe,” “expect,” “well positioned,” “look forward,” “anticipated,” “continued,” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2016, and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

CONTACTS:

Media:
Michael Lampe
Scient Public Relations
(484) 575-5040
michael@scientpr.com

Investors:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Monday, April 3rd, 2017 Uncategorized Comments Off on $PRTK Positive #Phase3 Study of #Omadacyclin in Pneumoniae

$NVCR Landmark #GBM Results: #Optune™ with Standard of Care Chemo, #Temozolomide

Final analyses provide unprecedented five-year survival advantage reinforcing Optune plus temozolomide as a combination treatment for glioblastoma patientsSurvival benefit was maintained in all patient subgroups, including those with the worst prognostic features

Novocure (NASDAQ:NVCR) announced today final results from its phase 3 pivotal EF-14 trial adding Optune to standard temozolomide chemotherapy for the treatment of newly diagnosed glioblastoma (GBM). Landmark analyses show a consistent and maintained improvement in overall survival at two, three, four and five years. The final results include data from all 695 patients included in the EF-14 trial with a median follow-up of 40 months.

The two-year survival rate increased from 30 percent to 43 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. The five-year survival rate increased from five percent to 13 percent for patients treated with Optune together with temozolomide versus patients treated with temozolomide alone. These are the best results reported for newly diagnosed GBM patients in a phase 3 trial to date and represent clinically meaningful increases in landmark survival rates (hazard ratio, 0.63; p<0. 00006).

EF-14 Principal Investigator Roger Stupp, M.D., Associate Director for Strategic Initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, presented these late breaking results today, April 2, during a press briefing and oral presentation (Abstract CT007) at the American Association for Cancer Research Annual Meeting 2017 in Washington D.C.

“When I started treating patients with GBM 20 years ago, the majority of patients died within less than one year and long-term survival was nearly absent. Now, we see a meaningful improvement in survival at two years and beyond,” Dr. Stupp said. “With the combination of Optune and temozolomide, one out of seven patients is living longer than five years.”

“This is the first positive phase 3 trial in newly diagnosed GBM since we demonstrated the efficacy of temozolomide in 2005, establishing it as a standard first-line therapy,” continued Dr. Stupp. “Beyond GBM, I believe this trial establishes an entirely different approach to cancer treatment with minimal toxicity which may be well suited for combination with conventional treatments for many other cancer types.”

GBM is the most common form of primary brain cancer. An estimated 12,500 people are diagnosed with GBM in the United States each year. Prior to the approval of Optune, the median overall survival for patients with newly diagnosed GBM was approximately 15 months with standard therapies. Combining Optune with temozolomide resulted in a statistically significant extension of median overall survival to 21 months in Novocure’s phase 3 pivotal EF-14 trial.

“We are excited that combination therapy with Optune plus temozolomide continues to show a meaningful extension of long-term survival for newly diagnosed GBM patients,” said Elizabeth M. Wilson, President and CEO of the American Brain Tumor Association. “Before temozolomide was approved, newly diagnosed GBM patients only had a 1.9 percent five-year survival rate, so to see numbers that are over six times that rate shows the significant progress that has been made in treating this disease.”

The data presented confirmed that the overall survival benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups including young versus elderly patients, patients with methylated versus unmethylated MGMT promoter and patients who underwent any extent of tumor resection. The data showed a safety profile consistent with previous reports of data from the study.

“These data further support our belief that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM,” said Asaf Danziger, Novocure’s CEO. “The efficacy shown in EF-14 for GBM gives us hope that TTFields used in combination other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors.”

About Novocure

Novocure is an oncology company developing a profoundly different cancer treatment centered on a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Approved Indications

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.

In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.

In Japan, Optune (NovoTTF-100A) is approved in the treatment of adult patients with supra-tentorial glioblastoma (GBM) and is used following maximal safe surgical resection and radiation therapy.

Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.

Important Safety Information

Contraindications: Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions: Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by Novocure (the device manufacturer).

Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.

The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.

The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.

The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.

All servicing procedures must be performed by qualified and trained personnel.

Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.

Do not wet the device or transducer arrays.

If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.

Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2017, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

 

Media and Investors:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com

Monday, April 3rd, 2017 Uncategorized Comments Off on $NVCR Landmark #GBM Results: #Optune™ with Standard of Care Chemo, #Temozolomide

$EXPI Reports 137% Revenue Growth in FY16, Record Q4

2016 Agent Growth of 178%; Drives Revenue Growth of 137% to Record $54.2 Million

BELLINGHAM, WA –(April 03, 2017) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, has provided a corporate update and its financial results for the fourth quarter and full year ended December 31, 2016.

2016 Company Highlights

  • Revenues in 2016 increased 137% to $54.2 million compared to $22.9 million in 2015.
  • Net loss in 2016 increased to $(26.0) million, or $(0.51) per diluted share, compared to net loss of $(4.6) million, or $(0.09) per diluted share in 2015. The net loss in 2016 was primarily due to non-cash charges as a result of a $20.5 million valuation increase of the intrinsic value of certain options due to an increase in share price during the period, and a $4.3 million increase in stock compensation expense. This compares to a $3.4 million valuation increase of the intrinsic value of certain options and a $1.2 million increase in stock compensation expense in 2015.
  • Adjusted EBITDA (a non-GAAP financial measure) increased 397% to $1.6 million in 2016, compared to $0.3 million in 2015.
  • Agents and brokers on the eXp Realty platform increased 178% to 2,401 in 2016, compared to 864 at the end of 2015. On March 15, 2017, the number of agents and brokers surpassed 3,000.

Management Commentary

“2016 established us as one of the largest and fastest growing brokerages in North America as we nearly tripled in size over the past year,” said Glenn Sanford, Founder, CEO and Chairman of eXp World Holdings, Inc. “Our strong revenue and adjusted EBITDA growth in 2016 showcases the leverage in our model, which we expect to continue to be evident as we execute on our overall strategy.

“Driving this is our cloud-based brokerage model, which creates a strong value proposition for agents and has allowed us to attract some of the top producers, as well as some of the highest ranking teams, throughout the U.S. and Canada. We have become a leading brokerage of choice for agents due to eXp Realty’s unique value proposition.

“Throughout 2016 and into 2017, we have continued to focus on investing in the infrastructure and tools necessary to support our growth and ensure scalability of eXp’s Realty’s business model. The investments we are making today will allow us to support a much larger, more mature organization well into the future. We expect our robust growth to continue to increase both in terms of agent count and revenues, along with our value proposition to our agent-owners and shareholders.”

Fourth Quarter 2016 Financial Results

Revenues increased 181% to a record $18.0 million in the fourth quarter of 2016, compared to $6.4 million in the fourth quarter of 2015. Sequentially, revenues increased 14% when compared to revenue of $15.8 million in the third quarter of 2016. This growth is a direct result of the increased agent count and corresponding higher revenues realized by the Company’s real estate brokerage division, eXp Realty.

In the fourth quarter of 2016, eXp Realty added 585 agents and brokers to its platform, an increase of 309% when compared to 143 agents and brokers added in the fourth quarter of 2015. This represents a sequential increase of 32% when compared to 418 agents added in the third quarter of 2016. eXp Realty ended 2016 with 2,401 real estate professionals on its platform across 42 states, the District of Columbia and Alberta, Canada. On March 15, 2017, eXp Realty surpassed the 3,000 agent milestone on its platform.

During the fourth quarter of 2016, operating loss was $4.7 million, compared to a $1.0 million operating loss in the same quarter of 2015. The increase in operating loss was primarily due to a significant increase in non-cash stock compensation expense of $3.7 million, and an increase in non-cash stock option expense of $0.04 million, due to an increase in share price during the period.

Adjusted EBITDA (a non-GAAP financial measure) in the fourth quarter of 2016 totaled $94,000, compared to $40,000 in the fourth quarter of 2015.

Net loss for the three months ended December 31, 2016 was $4.6 million, or $(0.09) per diluted share, compared to net loss of $7.1 million, or $(0.14) per basic and diluted share, for the fourth quarter of 2015. The increased net loss was primarily attributed to the significant increase in aforementioned non-cash stock option and stock compensation expenses.

Full Year 2016 Financial Results

eXp World Holdings reported revenue of $54.2 million for the year ended December 31, 2016, an increase of 137% compared to the prior year. This increase was mainly attributable to the 178% growth of the agent base during 2016, as eXp Realty grew from 864 to 2,401 agents.

In 2016, eXp Realty added 1,537 agents and brokers to its platform, an increase of 287% when compared to the 397 agents and brokers added in 2015. eXp Realty had 2,401 brokers and agents on its platform on December 31, 2016.

Operating loss for the full year 2016 was $26.0 million, an increase from $4.5 million in the same period in 2015. The increase in operating loss was primarily due to a significant increase in non-cash stock option expense of $20.5 million due to an increase in share price during the period, as well as a significant increase in non-cash stock compensation expense of $4.3 million as a result of agents joining the eXp Realty platform.

Adjusted EBITDA in 2016 increased 397% to $1.6 million, compared to $0.3 million in 2015.

Net loss in 2016 was $(26.0) million, or $(0.51) per diluted share, compared to net loss of $(4.6) million, or $(0.09) per diluted share in 2015. The increased net loss was primarily attributed to the aforementioned significant increase in non-cash stock option and stock compensation expenses.

Cash and cash equivalents as of December 31, 2016 were $1.7 million compared with $0.6 million as of December 31, 2015. Net operating cash flow for the year ended December 31, 2016 was $1.0 million, an increase of 195% from the last year.

About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) is the holding company for eXp Realty LLC, the Agent-Owned Cloud Brokerage®. As a full-service real estate brokerage, eXp Realty provides 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an attractive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.

As a publicly-traded company, eXp World Holdings, Inc. uniquely offers real estate professionals within its ranks opportunities to earn company stock for production and contributions to overall company growth.

For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpRealty.com.

Use of Non-GAAP Financial Measures

To provide investors with additional information regarding our financial results, this press release includes references to Adjusted EBITDA, a non-GAAP financial measure. We view Adjusted EBITDA as an operating performance measure and, as such, we believe that the GAAP financial measure most directly comparable to it is net income (loss). We define Adjusted EBITDA as net income excluding interest, income taxes, depreciation, amortization, and stock based compensation. We believe that Adjusted EBITDA provides us an important measure of operating performance, primarily from a cash flow standpoint, and enhances comparability while providing investors with useful insight into the underlying trends of the business. Our use of Adjusted EBITDA has limitations as an analytical tool, and this measure should not be considered in isolation or as a substitute for an analysis of our results as reported under GAAP, as the excluded items may have significant effects on our operating results and financial condition. Additionally, our measure of Adjusted EBITDA may differ from other companies’ measure of Adjusted EBITDA. When evaluating our performance, Adjusted EBITDA should be considered with other financial performance measures, including various cash flow metrics, net income and other GAAP results. In the future, we may disclose different non-GAAP financial measures in order to help our investors and others more meaningfully evaluate and compare our future results of operations to our previously reported results of operations.

Safe Harbor Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.

EXP WORLD HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2016 2015
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 1,684,608 $ 571,814
Restricted cash 481,704 148,613
Accounts receivable, net of allowance $133,845 and $2,342, respectively 3,015,767 341,643
Prepaids and other assets 383,563 84,451
TOTAL CURRENT ASSETS 5,565,642 1,146,521
OTHER ASSETS
Fixed assets, net 538,405 110,195
TOTAL OTHER ASSETS 538,405 110,195
TOTAL ASSETS $ 6,104,047 $ 1,256,716
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable $ 317,420 $ 89,984
Customer deposits 481,704 148,613
Accrued expenses 2,742,119 425,613
Current portion of notes payable 35,778
TOTAL CURRENT LIABILITIES 3,577,021 664,210
Commitments and contingencies
STOCKHOLDERS’ EQUITY
eXp World Holdings, Inc. Stockholders’ Equity:
Common Stock, $0.00001 par value 220,000,000 shares authorized;
52,316,679 shares and 50,168,195 shares issued and outstanding at
December 31, 2016 and December 31, 2015, respectively 523 502
Additional paid-in capital 34,526,859 6,611,781
Accumulated deficit (32,004,561 ) (5,991,088 )
Accumulated other comprehensive income (loss) 4,205 (9,113 )
Total eXp World Holdings, Inc. stockholders’ equity 2,527,026 612,082
Non-controlling interests in subsidiary (19,576 )
TOTAL STOCKHOLDERS’ EQUITY 2,527,026 592,506
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 6,104,047 $ 1,256,716
The accompanying notes are an integral part of these consolidated financial statements.
EXP WORLD HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended December 31,
2016 2015
Net revenues $ 54,179,511 $ 22,866,787
Operating expenses
Cost of revenues 46,726,533 19,456,409
General and administrative 32,237,501 7,257,961
Professional fees 645,024 439,763
Sales and marketing 570,844 211,456
Total expenses 80,179,902 27,365,589
Net income (loss) from operations (26,000,391 ) (4,498,802 )
Other income and (expenses)
Other income 15 23
Interest expense (370 ) (1,127 )
Total other income and (expenses) (355 ) (1,104 )
Income (loss) from before income tax expense (26,000,746 ) (4,499,906 )
Income tax expense (42,528 ) (103,069 )
Net income (loss) (26,043,274 ) (4,602,975 )
Net loss attributable to non-controlling interest in subsidiary 29,801 21,526
Net income (loss) attributable to common shareholders $ (26,013,473 ) $ (4,581,449 )
Net income (loss) per share attributable to common shareholders
Basic from continuing operations $ (0.51 ) $ (0.09 )
Diluted from continuing operations $ (0.51 ) $ (0.09 )
Weighted average shares outstanding
Basic 51,081,949 49,409,266
Diluted 51,081,949 49,409,266
The accompanying notes are an integral part of these consolidated financial statements.
EXP WORLD HOLDINGS, INC.
RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA
US-GAAP NET INCOME (LOSS) TO ADJUSTED EBITDA RECONCILIATION
Fiscal Year Ended,
2015
December 31,
2016
Adjusted EBITDA reconciliation
Net Income / (Loss) $ (4,602,975 ) $ (26,043,274 )
Interest 1,127 370
Taxes 103,069 42,528
Depreciation & Amortization 26,304 58,374
Stock Compensation 1,293,077 5,559,898
Stock Option 3,497,491 21,964,472
Adjusted EBITDA $ 318,093 $ 1,582,368

 

US-GAAP NET INCOME (LOSS) TO ADJUSTED EBITDA RECONCILIATION
Quarter Ended,
Adjusted EBITDA reconciliation Mar-15 Jun-15 Sep-15 Dec-15 Mar-16 Jun-16 Sep-16 Dec-16
Net Income / (Loss) (16,817 ) (4,998,154 ) $ 1,509,720 $ (1,097,724 ) $ (625,447 ) $ (6,012,627 ) $ (14,655,711 ) $ (4,749,489 )
Interest 461 464 202 370
Taxes 18,643 7,080 1,244 76,102 11,603 13,968 7,444 9,513
Depreciation & Amortization 5,323 7,824 5,863 7,294 12,626 12,929 12,555 20,264
Stock Compensation 99,798 672,327 212,951 308,001 248,725 482,984 795,401 4,032,788
Stock Option (171,807 ) 4,384,538 (1,461,593 ) 746,353 433,530 6,117,510 14,632,458 780,974
Adjusted EBITDA (64,399 ) 74,079 $ 268,387 $ 40,026 $ 81,037 $ 614,764 $ 792,147 $ 94,420

Investor Relations Contact:
Greg Falesnik
Managing Director
MZ Group – MZ North America
949-385-6449
Email contact

www.mzgroup.us

Monday, April 3rd, 2017 Uncategorized Comments Off on $EXPI Reports 137% Revenue Growth in FY16, Record Q4