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Eagle Pharmaceuticals, Inc. Reports Second Quarter 2016 Results

On August9, 2016 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and six-months ended June 30, 2016 (Press release, Eagle Pharmaceuticals, AUG 9, 2016, View Source [SID:1234514398]). Highlights of and subsequent to the second quarter of 2016 include:

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Business Highlights:

Bendeka total market share rose to 80%, as of Aug 5, 2016;
US Food and Drug Administration ("FDA") determined that no additional human safety and efficacy data is required for the submission of Eagle’s New Drug Application ("NDA") for Ryanodex for the treatment of exertional heat stroke ("EHS"), further confirming that a hybrid development program comprised of clinical data from EHS patients and positive preclinical data from animal studies constitutes an adequate regulatory pathway for the NDA submission;
Eagle reduced royalty payments owed for Ryanodex from 15% to 3% for a purchase price of $15 million in cash;
Discussions with the FDA regarding the design of a human study for RTU bivalirudin are underway;
Michael Graves appointed Chairman of the Board of Directors, Douglas Braunstein and Robert Glenning joined the board; and,
Eagle’s Board of Directors authorized a share repurchase program of up to $75 million in Eagle stock.
Financial Highlights:

Total revenue was $40.9 million during the second quarter of 2016 compared to $6.0 million for the three months ended June 30, 2015;
Product sales increased to $9.6 million during the second quarter of 2016 compared to $3.7 million for the three months ended June 30, 2015;
Sales of Ryanodex grew 81% quarter over quarter to $3.4 million during the second quarter of 2016;
Net income was $13.1 million, or $0.84 per basic and $0.80 per diluted share, compared to a net loss of $8.2 million, or $(0.53) per basic and diluted share, for the three months ended June 30, 2016 and 2015, respectively; and,
Cash and cash equivalents were $75.6 million and accounts receivable were $52.0 million as of June 30, 2016.
"During the quarter, we gained clarity on Bendeka and its associated cash flows through 2019. And, we are confident in our ability to continue to drive growth beyond 2019. Our meeting with the FDA provides us with an agreement for Ryanodex expansion. And, our Company’s cash position allows us to optimize the deployment of capital for our shareholders, a process we have already begun. With our new board in place, we are well positioned to take full advantage of the opportunities before us," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"Bendeka now commands 80% of a branded market and will be an important earnings driver through at least 2019. With Eagle’s right to launch our bendamustine 500mL formulation at any time and the right, under certain circumstances, to take back Bendeka in 2019, we believe our bendamustine franchise will be a solid contributor to Eagle’s growth for many years to come," added Tarriff.

"Likewise, we are excited about the potential of our pipeline to drive value beyond 2020. We expect the Ryanodex portfolio to be a key contributor to our growth. The FDA’s determination that the pivotal study we conducted on EHS patients combined with the clinical animal studies we are working on now will be sufficient to complete our NDA submission means that, if approved, Ryanodex for EHS could be on the market as early as next year, assuming the animal studies are successful. In parallel, we continue to explore additional indications for Ryanodex in the treatment of Ecstasy and methamphetamine intoxication, and are advancing multiple other product candidates through the development process, each of which could open up significant new markets for us," added Tarriff.

"As Eagle transitioned to a fully commercial company, we were able to grow our cash position significantly without incurring any debt. We are committed to deploying our excess capital prudently. As such, we signed an agreement that reduces our royalty obligations for Ryanodex. Eagle’s board has also approved the purchase of up to $75 million in Eagle’s stock. We will continue to evaluate opportunistic ways to invest our capital, reflecting our commitment to maximizing the value of our formulations and ensuring the long term earnings potential of the business," concluded Tarriff.

Second Quarter 2016 Financial Results

Total revenue for the three months ended June 30, 2016 was $40.9 million, as compared to $6.0 million for the three months ended June 30, 2015. A summary of total revenue is outlined below:

Three Months Ended
June 30, Increase
2016 2015
(in thousands)
Product sales $ 9,607 $ 3,730 $ 5,877
Royalty income 31,311 2,272 29,039
Total revenue $ 40,918 $ 6,002 $ 34,916

Product sales increased $5.9 million to $9.6 million driven by increases in Bendeka, Non-Alcohol Docetaxel Injection, Argatroban, and Ryanodex net product sales, offset by a decrease in net product sales of diclofenac-misoprostol. Royalty income increased $29.0 million to $31.3 million, as a result of the launch of Bendeka in January 2016.

Cost of revenue increased by $8.1 million to $11.5 million in the three months ended June 30, 2016 from $3.3 million in the three months ended June 30, 2015. This $8.1 million net increase resulted from $0.5 million in cost of revenue for Non-Alcohol Docetaxel Injection, an increase of $7.0 million related to the cost of Bendeka product sales, an increase of $0.5 million in cost of revenue for Ryanodex, and an increase of $0.1 million in cost of revenue for EP-1101.

Research and development expenses decreased by $2.2 million to $3.7 million in the three months ended June 30, 2016, compared to $5.9 million in the prior year quarter. The decrease is due to a decrease in spending on bivalirudin and cost reimbursement for Bendeka, offset by an increase in spending for the successful completion of the clinical treatment portion of the safety and efficacy study of Ryanodex for exertional heatstroke, an increase in project spending for pemetrexed, and investment in other pipeline projects.

SG&A expenses increased $6.9 million to $12.1 million in the second quarter of 2016 compared to $5.1 million in the three months ended June 30, 2015. Personnel-related expenses accounted for the bulk of the $7.0 million increase and were due to overall expansion of the business.

Net income for the second quarter was $13.1 million, or $0.84 per basic share and $0.80 per diluted share, compared to a net loss of $8.2 million, or $0.53 per basic and diluted share in the three months ended June 30, 2015, as a result of the factors discussed above.

Liquidity

As of June 30, 2016, the Company had $75.6 million in cash and cash equivalents; $52.0 million in receivables, with approximately $40 million due from Teva Pharmaceutical Industries Ltd. ("Teva"); $202.7 million in additional paid in capital; $107.8 million in stockholders’ equity; and no debt.

Events Subsequent to the End of the Second Quarter

Eagle purchased the majority of the royalty obligation on Ryanodex net sales, reducing its obligation from 15% to 3% in exchange for $15 million in cash.

Changes in the structure of Eagle’s shareholders’ stock holdings, which occurred in the second quarter of 2016 may trigger how Eagle utilizes accumulated Net Operating Losses ("NOL"). Eagle is evaluating whether or not these changes have, or soon will, trigger a technical change of control, as it is defined in Section 382 of the Internal Revenue Code. Upon a Section 382 change of control, the Company is required to amortize NOL utilization. How the Company utilizes accumulated NOL of approximately $99 million may be impacted by the outcome of this process. Eagle’s preliminary assessment is that the Company is close to a technical change of control. We estimate that should the Company be required to amortize NOL, there will be a cash impact of approximately $10 million incurred over the next few quarters.

On August 2, 2016, the Board of Directors has approved a share repurchase program, under which Eagle may repurchase up to $75 million of its outstanding common stock. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Repurchases under the program will be made from time to time on the open market at prevailing market prices or in privately negotiated transactions in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, as amended, as determined by management and the Board of Directors in their discretion and subject to market conditions, applicable legal requirements, and other relevant factors.

Q2 2016 Financial Report

On August 9, 2016 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biomedicine firm engaged in the development of immunotherapies for cancer and effective stem cell therapies for degenerative diseases, reported financial results and business highlights for the second quarter and six months ended June 30, 2016 (Press release, Cellular Biomedicine Group, AUG 9, 2016, View Source [SID:1234514395]).

"In the first half of 2016, we made several significant advancements towards the operating objectives for our dual technology platforms of immuno-oncology and stem cells," commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer. "The completion of a $43.13 million strategic investment has strengthened our capabilities to continue to invest in research and development, optimize our clinical process and expand our focus on the CAR-T pipeline. We anticipate in the coming quarters launching clinical trials in China on CAR-T CD19 and CD20 constructs and to further bolster our immuno-oncology pipeline. We have completed patient treatment in the Phase I trial of AlloJoinTM, our off-the-shelf allogeneic adipose-derived progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA) in China, and are encouraged to see no serious adverse events thus far. We continue to evaluate the feasibility of initiating a clinical study of AlloJoinTM under IND to support the same indication in the United States. As we look forward to the remainder of 2016, we will continue to prioritize our immuno-oncology and stem cell clinical pipelines for multiple indications that serve large addressable markets while facilitating future partnerships and collaborations that will enhance our ability to develop safe and effective therapies."

Second Quarter and First Half 2016 Financial Performance

1. Cash Position:Cash and cash equivalents as of June 30, 2016 were $47.5 million compared to $14.9 million as of December 31, 2015. This increase was due to a private placement financing in February and April 2016 for gross proceeds of approximately $43 million, offset by cash used in operating and investment activities.
2. Net Cash Used in Operating Activities:Net cash used in operating activities for the quarter and six months ended June 30, 2016 was $5.2 million and $8.8 million, respectively, compared to $3.3 million and $5.7 million for the same periods in 2015.
3. G&A Expenses: General and administrative expenses for the quarter and six months ended June 30, 2016 were $3.1 million and $5.8 million, respectively, compared to $3.8 million and $6.4 million for the same periods in 2015.
4. R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2016 were $3 million and $5.4 million respectively, compared to $1.3 million and $2.8 million for the same periods in 2015.
5. Net Loss:Net loss allocable to common stock holders for the quarter and six months ended June 30, 2016 was $7.2 million and $11.4 million respectively, compared to $5 million and $9.3 million for the same periods in 2015.

Recent Business and Technology Highlights

Completed treatment for eighteen patients in Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA);
China Patent Office granted the Company’s patent application on genetically engineered anti-CD20 Chimeric Antigen Receptor-positive NKT cells, its production and application;
Advanced the Company’s cash position following the closing of an agreement with Wuhan Dangdai Science & Technology Industries Group Inc. to invest an aggregate of $43.13 million for 2.27 million shares of the Company’s common stock, representing a 16.2% post-money stake investment as of April 15, 2016;
Appointment of Dr. Zhou Hansheng as a member of the Board of Directors.
Pipeline Update

Conducted single-center Phase I trial of AlloJoinTM haMPC therapy for Knee Osteoarthritis (KOA) in China
Eighteen patients have received two dose intra-articular injections at three week intervals and have not been presented with any serious adverse events thus far
Patients will be monitored over the next 12 months for safety and efficacy signs
Phase I clinical research trial for AlloJoin is registered at ClinicalTrials.gov under the number NCT02641860
Anticipate announcement of sponsorship of multi-indication clinical studies with multiple institutions using CBMG’s CD19 and CD20 constructs and stem cell technologies by Q12017 after the technologies are optimized and manufacturing capabilities are in place
About Cellular Biomedicine Group

Valeant Pharmaceuticals Reports Second Quarter 2016 Financial Results

On August 9, 2016 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) ("Valeant" or the "Company") reported second quarter 2016 financial results (Press release, Valeant, AUG 9, 2016, http://ir.valeant.com/news-releases/2016/08-09-2016-110228006 [SID:1234514390]).

"We continue to make progress towards stabilizing the organization," said Joseph C. Papa, chairman and chief executive officer. "We are also announcing a new strategic direction for Valeant today, which, at its heart has a mission to improve patients’ lives, and will involve reorganizing our company and reporting segments. I am continuously encouraged by the commitment of our employees who work hard daily, rebuilding our relationships with prescribers, patients and payors, and regaining the trust of our debt holders and shareholders. Although it will take time to implement and execute our turnaround plan, I am confident that we will show progress in the coming quarters."

Total Revenues
Total revenues decreased 11% to $2.42 billion in the second quarter of 2016 as compared to $2.73 billion in the second quarter of 2015, driven primarily by a decline in product sales revenues from our existing business, as well as negative foreign currency exchange impact, partially offset by incremental product sales revenues from acquisitions completed in 2015.

In the Developed Markets segment, revenues declined 14%, driven mainly by a decline in product sales revenue from our existing business, primarily as a result of lower average realized prices which were in turn impacted by higher managed care rebates, lower price appreciation credits, our fulfillment agreement with Walgreens, and higher group purchasing organization (GPO) rebates. These factors were partially offset by an increase in contribution from acquisitions completed in 2015, primarily from Salix Pharmaceuticals, Ltd. and certain assets of Dendreon Corporation.

In the Emerging Markets segment, revenues were flat as compared to the second quarter of 2015, primarily due to a small decline in the existing business and negative foreign currency exchange impact, which were partially offset by incremental product sales revenue from acquisitions completed in 2015.

Operating Expenses
Cost of goods sold were $647 million in the second quarter of 2016 as compared to $670 million in the second quarter of 2015, a decrease of 3% primarily due to a decline in sales volumes, partially offset by increased sales from acquisitions completed in 2015, primarily of Salix and Amoun Pharmaceutical Company S.A.E.

Selling, general and administrative expenses ("SG&A") were $672 million in the second quarter of 2016, as compared to $686 million in the second quarter of 2015. As a percentage of revenue, SG&A was 28% in the second quarter of 2016, as compared to 25% in the second quarter of 2015.

Research and development ("R&D") expenses were $124 million in the second quarter of 2016 as compared to $81 million in the second quarter of 2015, primarily due to the development programs related to the Company’s dermatology product portfolio, as well as spending on brodalumab and programs acquired in the Salix acquisition.

Net Income (Loss)
Net loss in the second quarter of 2016 was $302 million as compared to a net loss of $53 million in the second quarter of 2015. Adjusted net income (non-GAAP) in the second quarter of 2016 was $488 million as compared to $751 million in the second quarter of 2015.

Cash Flow
Cash flow from operations was $448 million in the second quarter of 2016 as compared to $411 million in the second quarter of 2015, an increase of 9% over the same period in 2015.

Business Development
We have taken steps to streamline our portfolio in the second quarter. We have sold, or agreed to sell, the brodalumab EU rights, Synergetics USA OEM business, and Ruconest for a total combined upfront payment of $181 million and additional consideration up to $329 million for achieving specific approval and sales milestones.

Specific to Ruconest, today the Company entered into a definitive agreement to divest all North American commercialization rights to Ruconest (recombinant human C1 esterase inhibitor) to Pharming Group N.V. ("Pharming"). Under the terms of the agreement, Pharming will pay Valeant aggregate consideration of up to $125 million, including an upfront fee of $60 million payable upon closing and certain sales-based milestone payments of up to $65 million. The transaction is subject to customary closing conditions, in addition to Pharming obtaining certain financing. Ruconest was classified as held for sale as of June 30, 2016 and an impairment loss of $199 million was recorded in the second quarter of 2016.

2016 Guidance
The Company is reconfirming its full year 2016 guidance. Total revenue is expected to be in the range of $9.9 – $10.1 billion. Adjusted EPS (non-GAAP) is expected to be in the range of $6.60 – $7.00. Adjusted EBITDA (non-GAAP) is expected to be in the range of $4.80 – $4.95 billion.

Other than with respect to total revenue, the Company only provides guidance on a non-GAAP basis. The Company does not provide reconciliations of forward-looking Adjusted EPS (non-GAAP) and Adjusted EBITDA (non-GAAP) to GAAP, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations. In periods where there are not expected to be significant acquisitions or divestitures, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, that would otherwise be treated as non-GAAP to calculate projected net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation settlements) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amounts of these deductions may be material and, therefore, could result in projected GAAP EPS and GAAP net income (loss) being materially less than projected Adjusted EPS (non-GAAP) and Adjusted EBITDA (non-GAAP).

Approval for Clinical Trial for New Drug Goserelin Acetate Extended-release Microspheres for Injection (LY01005) in China

On August 9, 2018 The Board of Directors (the ‘‘Board’’) of Luye Pharma Group Ltd. (the ‘‘Company’’, together with itssubsidiaries, the ‘‘Group’’) reported that the Group’s product candidate, Goserelin Acetate Extended Release Microspheres for Injection (LY01005), has obtained the approval from the China Food and Drug Administration (the ‘‘CFDA’’) to initiate clinical trials for the treatment ofcarcinoma of the prostate (Press release, Luye Pharma, AUG 9, 2016, View Source;id=663103 [SID1234525075]). This product has also obtained the approval from the United States Food and Drug Administration (the ‘‘FDA’’) to initiate clinical trials for the treatment of carcinoma of theprostate in March this year.

LY01005 is the Group ’s monthly extended release microspheres for intramuscular formulation ofgoserelin acetate, a gonadotropin -releasing hormone agonist, applying our microspheres injection technology. It is an oncology product candidate for the treatment of certain cancers and other indications, including prostate cancer, breast cancer and endometriosis. LY01005 is now being registered via a 505(b)(2) pathway of the United States Federal Food, Drug and Comestic Act in the United States ( ‘‘U.S.’’). The Company believes its extended-release microspheres formulation ofgoserelin acetate may have similar bioavailability as compared to another marketed product (goserelin implant), with better patient compliance and more stable efficacy.

The Company had filed a Patent Cooperation Treaty application for its goserelin microsphere pharmaceutical composition in 2014 and such PCT application entered into the U.S., Europe, Japan and certain other countries in 2015.

According to IMS Health Incorporated, the market size for gonadotropin -releasing hormone agonist products in China in 2015 was approximately RMB2.79 billion, and grew at a compound annual growth rate of 21.6% from 2013 to 2015. The Company believes that LY01005 has a good marketing potential – 1 – and will provide an impetus to the Group ’s development in the oncology therapeutic area. In addition toChina and the U.S., the Company is also targeting to obtain clinical trial approval for this potential new drug in Europe and Japan.

Apart from LY01005, the Company is currently developing several new pharmaceutical products both in China and the U.S., including Risperidone Extended Release Microspheres for Injection (LY03004 ), which had been confirmed by the FDA for New Drug Application for submission in the U.S. without additional clinical trials, Rotigotine Extended Release Microspheres for Injection (LY03003 ), which had completed phase I trials in the U.S. and Ansofaxine Hydrochloride Extended Release Tablets (LY03005 ) which had also completed phase I trials in the U.S.

CRT and Alta Innovations join forces to commercialise world-leading research

On August 9, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the commercial arm of Cancer Research UK – the University of Birmingham and its commercial arm, Alta Innovations (Alta), reported an agreement to work together to develop and commercialise the university’s cancer research (Press release, Cancer Research Technology, SEP 9, 2016, View Source [SID1234523183]).

The two-year agreement draws on the strengths of each organisation to accelerate commercialisation of the University’s world-leading research in cancer into diagnostics, treatments and technologies that could one day benefit patients.

Alta will use its expertise in working closely with world-leading scientists at the University to identify the most promising cancer research opportunities and CRT will use its expertise in commercialising cancer research and its vast network across the pharmaceutical and biotechnology industry to identify and translate promising research at the university.

CRT will work together with Alta and the University of Birmingham’s academics to identify promising cancer opportunities, including the significant clinical expertise available and the university’s leading research in areas such as immunology and genomics.

Financial benefits that come from the work will be shared between CRT and the University of Birmingham. All financial returns for CRT are invested into Cancer Research UK’s life-saving research and all returns to the University are for the benefit of the educational charity.

Professor David Adams, head of the college of medical and dental sciences at the University of Birmingham, said: "Bringing Alta and CRT together in this way means we are giving our world-class cancer researchers access to a team of people with the right skills to give their ideas the fastest route to having an impact on patients’ lives."

Dr James Wilkie, CEO of Alta Innovations, said: "This agreement is built on a long standing working relationship. Our job is to ensure that the world-leading cancer research done here gets translated into better patient outcomes as fast as possible.

"Combining the skills that Alta and CRT have built up over many years will allow our researchers to accelerate the development of their world-leading ideas and patients will benefit from these being brought to market more quickly."

Dr Phil L’Huillier, CRT’s director of business management, said: "We’ve already seen some great successes from our work with Alta Innovations, such as the formation of Revitope Oncology in 2014, an exciting new immunotherapy company. So we’re delighted to be working with the University of Birmingham and Alta Innovations to help develop and commercialise pioneering research that could lead to new treatments to patients faster.

"Developing relationships of this kind draws on the strengths and expertise of both organisations. We hope to develop more relationships like this with other top UK universities in the future to accelerate research and bring new hope to patients."