On May 9, 2016 FibroGen, Inc. (NASDAQ: FGEN) ("FibroGen"), a research-based biopharmaceutical company, reported financial results for the quarter ended March 31, 2016 (Filing, Q1, FibroGen, 2016, MAY 9, 2016, View Source [SID:1234512416]).

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"We are pleased with the progress of our major development programs across the board," said Thomas B. Neff, chief executive officer of FibroGen. "FibroGen and our collaboration partners continue to advance the roxadustat global Phase 3 program in anemia of chronic kidney disease with the hope of providing a safer and more accessible option for patients. We remain on track to initiate new drug application submissions in 2016 for China and in 2018 for the United States. Data from our ongoing Phase 2 programs relating to FG-3019 continues to support the development of this antibody as a potential therapy for devastating and difficult-to-treat diseases."
Program Updates
Anemia in Chronic Kidney Disease (CKD): roxadustat (FG-4592)

· Timelines for roxadustat remain on track. The company expects to initiate new drug application submissions for roxadustat in 2016 for China and in 2018 for the U.S.

· FibroGen and partners AstraZeneca and Astellas are conducting a total of seven Phase 3 trials for registration in the U.S., Europe, and other territories. FibroGen has completed target enrollment for two out of the three FibroGen-sponsored studies, and we have achieved over 80% of target enrollment in the third study.

· The independent data safety monitoring board overseeing roxadustat U.S. and Europe Phase 3 studies met in April 2016 to review the roxadustat safety data, and confirmed that the trials should proceed with current Phase 3 protocols without modification.

· In China, we are conducting two pivotal Phase 3 trials with roxadustat. We are over 80% enrolled in our 300 patient dialysis study, for which the primary efficacy endpoint is 26 weeks, and expect to complete enrollment this month. We are approximately one-third enrolled in our 150 patient non-dialysis study, for which the primary efficacy endpoint is eight weeks, and expect to complete enrollment in the third quarter of 2016. We expect to be able to report data in both studies by year-end.
Fibrosis and Other Fibroproliferative Disease: FG-3019

· In idiopathic pulmonary fibrosis (IPF), promising data from our open-label, single-arm dose-finding trial in subjects with moderate to severe IPF were presented in a manuscript published in the European Respiratory Journal (on-line publication in March, and in-print publication in May of this year). Results of the study showed that after 48 weeks of treatment 35% of the subjects receiving FG-3019 had stable or improved lung fibrosis, 24% had improved fibrosis, both as measured by quantitative high resolution computed tomography. For subjects in the high dose group with baseline forced vital capacity (FVC)≥55% predicted, 37% showed improvement in pulmonary function (as measured by FVC) at the end of the initial 48 week treatment portion of the study. An accompanying editorial noted that, to the best of current knowledge, neither of the two currently approved IPF treatments are targeting connective tissue growth factor (CTGF), posing a promising basis for a future placebo-controlled trial combining our anti-CTGF antibody FG-3019 with pirfenidone or nintedanib.

· We continue to see promising preliminary data from our ongoing open-label Phase 2 study in patients with inoperable Stage 3 pancreatic cancer. Subjects entering the trial must have failed resection scoring, i.e., been found to have unresectable tumors, and thus not eligible for surgery. At present, of nine patients randomized to receive FG-3019 plus chemotherapy (standard-of-care) three patients continue on treatment, one discontinued treatment early due to a chemotherapy-related serious adverse event and five patients completed six months of treatment. All five who completed treatment were reassessed as eligible for resection based on standard scoring criteria set forth in the protocol. Seven patients have been randomized to the comparator arm with only standard of care chemotherapy. Of the seven patients, three experienced disease progression prior to completing treatment and four completed the treatment regimen, of which only one was reassessed as eligible for tumor removal.

· We continue to enroll subjects and add sites in our open-label Phase 2 study of FG-3019 in non-ambulatory Duchenne muscular dystrophy (DMD) patients.
Financial Highlights

· Net loss per basic and diluted share, for the quarter ended March 31, 2016, was $0.45 per share, an improvement of $0.33 per share as compared to the same period last year.

· At March 31, 2016, FibroGen had $309.9 million of cash, cash equivalents, investments, receivables and restricted cash.

· For the quarter ended March 31, 2016, revenue increased 74% and research and development expenses decreased 14% as compared to the same period last year, largely due to the fact that we had reached the 50/50 spending cap with AstraZeneca during the fourth quarter of 2015 on our initial funding obligations for roxadustat. Under an agreement between FibroGen and AstraZeneca, FibroGen’s total funding obligations for roxadustat development in CKD outside China are limited to $116.5 million. As of the end of the fourth quarter of 2015, the $116.5 million cap on our share of development costs for roxadustat has been reached. Therefore starting in the first quarter of 2016, we no longer share 50% of the development costs compared to the prior periods, as, Astellas and AstraZeneca are now responsible for funding future development and commercialization costs for roxadustat in CKD through launch for all territories, excluding China, where AstraZeneca pays 50% of development costs.

On May 9, 2016 Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, reported recent business and program highlights as part of its multi-year vision and financial results for the first quarter of 2016 (Press release, Epizyme, MAY 9, 2016, View Source [SID:1234512112]).

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"We have made significant progress in our clinical development program for tazemetostat and all four areas of our multi-year vision," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "We are well underway with plans to expand the tazemetostat clinical program into combination studies and its third cancer indication, continuing to advance our discovery pipeline and collaborative research efforts and have strengthened our team and business operations. With a number of milestones on the horizon, we are positioned to continue this momentum."

Accelerate Tazemetostat Program in Non-Hodgkin Lymphoma and Solid Tumors

Epizyme has submitted an abstract to present a study update from its phase 2 program in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on Lymphoma Biology in June. This presentation will include a progress update on the study enrollment, safety experience for all patients enrolled and an early look at clinical activity in the patient populations that have surpassed their futility hurdle as confirmed by the Independent Data Monitoring Committee (IDMC). The three arms confirmed to have surpassed the futility hurdle are: germinal center diffuse large B-cell lymphoma (DLBCL) with an EZH2 mutation; germinal center DLBCL with wild-type EZH2; and non-germinal center DLBCL. Futility in each of the DLBCL arms is based on observing at least one objective response in the first ten patients enrolled. Responses have been observed in the two arms enrolling patients with follicular lymphoma; however, neither arm has yet reached its futility hurdle, which is at least two objective responses out of the first ten patients enrolled.

The IDMC recently approved Epizyme’s planned expansion of enrollment in all five arms of the phase 2 study in patients with NHL. The total population will increase to 270 patients from 150. The three arms enrolling patients with DLBCL will now enroll 60 patients each, and the two arms enrolling patients with follicular lymphoma will now enroll 45 patients each. This expansion will enable more precision around the level of activity in each patient population, which will provide guidance for determining next steps in each population and the statistical design of potential subsequent studies. Pending abstract submission and acceptance, the Company plans to present a second study update at the ASH (Free ASH Whitepaper) Annual Meeting in late 2016.

Epizyme recently expanded the number of arms in the phase 2 study in adult patients with certain genetically defined solid tumor (INI1-negative tumors, SMARCA4-negative tumors or synovial sarcomas) to five arms from three due to a higher accrual of patients with certain types of INI1-negative tumors than it anticipated. The two arms enrolling patients with rhabdoid tumors and synovial sarcomas remain unchanged. A third arm will continue to enroll patients with other INI1-negative tumors, and the Company has now separated out two specific INI1-negative cohorts from the third arm. One arm will enroll patients with renal medullary carcinoma and another will enroll patients with epithelioid sarcoma. Pending abstract submission and acceptance, the Company plans to present preliminary data from the phase 2 adult solid tumor study at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in late 2016.

The phase 1 dose-escalation and expansion study of tazemetostat in pediatric patients with certain INI1-negative tumors, including rhabdoid tumors and synovial sarcomas, is enrolling well, and the study has escalated to the second dose level.
Expand Tazemetostat Program

In May, the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for tazemetostat for the treatment of adult patients with mesothelioma characterized by BAP1 loss-of-function. The Company plans to initiate a phase 2 trial in patients with mesothelioma in the third quarter of 2016.

Earlier today, Epizyme announced that it has entered into a collaboration agreement with the Lymphoma Academic Research Organisation (LYSARC) for the first planned combination trial of tazemetostat. LYSARC is the operational arm of the Lymphoma Study Association, a premier cooperative French lymphoma group. This phase 1b/2 study will evaluate tazemetostat administered together with R-CHOP as a front-line therapy for elderly, high-risk patients with DLBCL, and is expected to begin in mid-2016.

Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference in April further characterized the dosing and administration of tazemetostat. The findings show that tazemetostat is only a weak inducer of CYP3A-mediated metabolism, suggesting a low potential interaction with other treatments metabolized through this pathway. Pharmacokinetic data presented at that meeting also show that tazemetostat can be dosed with or without food. These findings further guide tazemetostat development as a monotherapy and in combination regimens.
Growth Discovery Pipeline

Epizyme scientists continue to advance the development of small molecule inhibitors against five targets that have been selected and prioritized for research.
Maintain Established Leadership Position

Epizyme added strength to its leadership team with new hires: Matthew Ros as Chief Operating Officer, Susan Graf as Chief Business Officer, Jeannie Chu as Vice President of Program and Portfolio Management and Michael Boretti, Ph.D. as Vice President of Business Development.
Q1 2016 Financials Results and Guidance

Collaboration revenue was $0.5 million for the quarter ended March 31, 2016, compared to $0.9 million for the same period last year. The period-over-period decrease reflects increased recognition of deferred revenue from upfront payments from the Celgene collaboration in the first quarter of 2016 offset by decreased recognition of deferred revenue from upfront payments and research and development revenue related to the GlaxoSmithKline collaboration compared to the first quarter of 2015 as no revenue was recognized with respect to the GSK collaboration in the first quarter of 2016.

Research and development (R&D) expenses were $17.7 million for the quarter ended March 31, 2016, compared to $57.1 million for the first quarter of 2015. The period-over-period decrease was driven by the first quarter 2015 payment to Eisai of $40.0 million related to the reacquisition of the worldwide rights, excluding Japan, to tazemetostat, and was partially offset by increased spending on the tazemetostat clinical development program.

Epizyme expects that R&D expenses will increase in 2016, when compared to 2015. The planned increase is primarily related to the development costs of tazemetostat, including Epizyme’s trials in patients with non-Hodgkin lymphoma and adult and pediatric patients with certain genetically defined solid tumors, as well as planned combination studies in patients with DLBCL and the planned study in patients with mesothelioma. In addition, discovery and preclinical research costs are expected to increase as the Company advances its wholly owned small molecule programs against five novel targets and continues the research efforts under its Celgene collaboration.

General and administrative (G&A) expenses were $5.8 million for the quarter ended March 31, 2016, compared to $5.2 million for the same period last year. The increase in G&A expense was largely due to higher professional services costs and personnel-related expenses associated with the expansion of Epizyme’s operations. Epizyme expects that G&A spend will increase in 2016 as compared to 2015 due to increases in staffing and infrastructure to support expanded clinical trial activities, increased research investment and other expanded operational activities, including increased intellectual property costs.

Net loss was $22.9 million for the quarter ended March 31, 2016, compared to a net loss of $61.3 million for the quarter ended March 31, 2015.

Cash and cash equivalents were $312.7 million as of March 31, 2016, compared with $208.3 million as of December 31, 2015. This increase in cash was driven by the Company’s January 2016 financing.
Financial guidance from Epizyme states that the Company believes its cash and cash equivalents as of March 31, 2016 will be sufficient to fund the Company’s planned operations through at least the end of 2017.

On May 9, 2016 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported financial results and business highlights for the first quarter 2016 (Press release, Juno, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166580 [SID:1234512138]).

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"In the first quarter, we continued to advance our CD19-directed portfolio – enrolling multiple trials, commencing manufacturing of clinical trial material from our Juno-operated facility, and securing Celgene’s opt-in to product candidates in our CD19 program, which will accelerate our pace outside of North America. Also, we recently reported encouraging early data for product candidates against two other targets, CD22 and WT-1, as our pipeline and research continue to progress beyond CD19," said Hans Bishop, Juno’s President and Chief Executive Officer. "Juno’s capabilities are growing, and we look forward to sharing more data with you later this quarter at ASCO (Free ASCO Whitepaper) and throughout 2016."

First Quarter 2016 and Recent Corporate Highlights
Clinical Progress:
CD19 Portfolio – An investigational new drug (IND) amendment cleared the FDA, allowing Juno to begin clinical manufacturing of JCAR015 for the Phase II ROCKET trial out of a Juno-operated manufacturing facility in Bothell, Washington. Juno plans to use this facility to manufacture product for Juno’s first commercial launches. Juno also announced the initiation of enrollment for its trial combining JCAR014 and MedImmune’s anti-PDL-1 immune checkpoint inhibitor, durvalumab.

JCAR018 – This CD22-directed, fully-human chimeric antigen receptor (CAR) T cell product candidate has the potential to treat or prevent CD19-negative relapses. JCAR018 reached two clinical milestones in a Phase I trial conducted at the National Cancer Institute (NCI) in pediatric and young adult relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL) patients, which triggered payments to Opus Bio in the first quarter of 2016 totaling 603,364 shares of Juno common stock. Investigators presented data from the ongoing Phase I study in pediatric and young adult r/r ALL patients at the American Association for Clinical Research (AACR) (Free AACR Whitepaper) 2016, showing all three patients at dose level 2 (1 x 106 cells/kg) achieved a complete remission and complete molecular remission as measured by flow cytometry. These patients remain in complete remission with follow-up ranging from 3 to 6 months. Limited cytokine release syndrome (CRS) and no severe neurotoxicity was seen at dose level 2. Dose limiting toxicity was observed at higher doses, so dosing will continue at dose level 2 (1 x 106 cells/kg). CD22-directed CAR T treatment has the potential, when combined with CD19-directed CARs, to meaningfully increase the percentage of ALL patients that experience long-term remissions.
JTCR016 – This WT-1-directed, T cell receptor (TCR) cell product candidate is currently being studied in acute myeloid leukemia (AML), refractory mesothelioma, and non-small cell lung cancer. In the first three solid organ tumor patients treated to date, all with mesothelioma, preliminary data presented at AACR (Free AACR Whitepaper) 2016 showed one patient with an ongoing partial response to the WT-1 TCR and one with stable disease. The clinical activity appeared to correlate with the pharmacokinetics of the engineered T cells, as the patient with the partial response had the best T cell expansion and persistence. JTCR016 was generally well-tolerated in these three refractory mesothelioma patients, with no evidence of severe CRS or severe neurotoxicity.

Corporate News:
Juno announced that Celgene exercised its option to develop and commercialize product candidates from Juno’s CD19 program outside North America and China. With the exercise of this option, Celgene paid Juno a fee of $50.0 million and the companies will now share global development expenses for product candidates in the CD19 program. Celgene has commercial rights outside of North America and China, and will pay Juno a royalty at a percentage in the mid-teens on any future net sales in Celgene’s territories of therapeutic products developed through the CD19 program. Juno retains commercialization rights in North America and China.
Juno acquired AbVitro, a leading next-generation single cell sequencing platform company that will augment Juno’s capabilities to create best-in-class engineered T cells against a broad array of cancer targets, including significantly improving the speed of generating TCR binders, while also enabling comprehensive profiling of functional immune repertoires with cancer tissues. Juno and Celgene have agreed in principle to enter an agreement to license Celgene a subset of the acquired technology and grant Celgene options to certain related potential product rights emanating from the acquired technology.
Juno announced, along with WuXi AppTec, the formation of a new company, JW Biotechnology (Shanghai) Co., Ltd., with a mission to develop novel cell-based immunotherapies for patients with hematologic and solid organ cancers in China. The new company will leverage Juno’s world-class CAR and TCR technologies and WuXi AppTec’s research and development and manufacturing platform and local expertise.
Juno announced the creation of a new, best-in-class clinical trials unit dedicated to immuno-oncology, in collaboration with the University of Washington, the Seattle Cancer Care Alliance, and the Fred Hutchinson Cancer Research Center (FHCRC). The clinical trials unit has been established to accelerate the clinical care of patients and the generation of translational medicine insights with cutting-edge immuno-oncology therapeutic candidates.
Juno reported that Celgene exercised its annual "top-up" right, purchasing 1,137,593 shares of Juno common stock at a price of $41.32 per share for an aggregate cash purchase price of $47.0 million.
First Quarter 2016 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities as of March 31, 2016 were $1.13 billion compared to $1.22 billion as of December 31, 2015. The decrease of $91.0 million is due to cash used in connection with the acquisition of AbVitro and cash used to fund operations, offset by cash proceeds of $47.0 million from Celgene for the purchase of 1,137,593 shares of Juno’s common stock. Celgene’s CD19 opt-in payment of $50.0 million occurred after the end of the first quarter.
Cash Burn: Excluding cash inflows and outflows from business development activities, cash burn in the first quarter of 2016 was $61.0 million including $4.0 million of capital expenditures, compared to $26.4 million in the first quarter of 2015. The increase of $34.6 million was primarily driven by cash outflows in connection with the overall growth of the business.
Revenue: Revenue for the three months ended March 31, 2016 was $9.8 million and included milestone revenue of $5.8 million received from Novartis and revenue recognized in connection with the Celgene collaboration agreement of $3.8 million.
R&D Expenses: Research and development expenses in the first quarter of 2016, inclusive of non-cash expenses and computed in accordance with GAAP, were $73.7 million compared to $57.8 million in the first quarter of 2015. The increase of $15.9 million was due to a $23.2 million non-cash expense associated with milestones achieved under its license agreement with Opus Bio related to Juno’s JCAR018 product candidate, which were paid through the issuance of 603,364 shares of Juno’s common stock, a $5.0 million payment to St. Jude in connection with the milestone achieved by Juno’s sublicensee Novartis, as well as increased costs incurred to execute Juno’s clinical development strategy, manufacture its product candidates, and expand its overall research and development capabilities.

For the three months ended March 31, 2016, Juno recorded a gain of $6.6 million related to the success payment liability and an expense of $38.9 million for the same period in 2015. The gain recorded in the first quarter of 2016 was primarily due to a decline in Juno’s stock price at March 31, 2016 compared to December 31, 2015.
Non-GAAP R&D Expenses: Non-GAAP research and development expenses for the three months ended March 31, 2016 and 2015 were $80.1 million and $17.0 million, respectively. Non-GAAP research and development expenses for the first quarter of 2016 include $9.1 million of stock-based compensation expense, $2.2 million of which was paid in connection with the acquisition of AbVitro, as well as the milestone payments described above. Non-GAAP research and development expenses for the first quarter of 2015 include $1.7 million of non-cash stock-based compensation expense. Non-GAAP research and development expenses for the first quarter of 2016 exclude the following:
A gain of $6.6 million associated with the change in the estimated value and elapsed service period for Juno’s potential success payment liabilities to FHCRC and Memorial Sloan Kettering Cancer Center (MSK).
Non-cash stock-based compensation expense of $1.2 million related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.
A gain of $1.0 million associated with the change in estimated fair value of the contingent consideration recorded in connection with the Stage and X-Body acquisitions.
Non-GAAP research and development expenses for the first quarter of 2015 exclude the following:
An expense of $38.9 million associated with the change in the estimated value and elapsed service period for Juno’s potential success payment liabilities to FHCRC and MSK.
Non-cash stock-based compensation expense of $1.9 million related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.
G&A Expenses: General and administrative expenses on a GAAP basis for the first quarter of 2016 were $16.0 million compared to $7.4 million for the first quarter of 2015. The increase of $8.6 million was primarily due to increased personnel expenses, including non-cash stock-based compensation expense, an increase in consulting fees including costs related to commercial readiness, and other expenses related to the growth of the business. General and administrative expenses include $4.9 million and $1.8 million of non-cash stock-based compensation expense for the three months ended March 31, 2016 and 2015, respectively.
GAAP Net Loss: Net loss for the three months ended March 31, 2016 was $71.1 million, or $0.72 per share, compared to $65.0 million, or $0.79 per share, for the same period in 2015.
Non-GAAP Net Loss: Non-GAAP net loss, which incorporates the non-GAAP R&D expense, for the three months ended March 31, 2016 was $77.5 million, or $0.78 per share, compared to $24.2 million, or $0.30 per share, for the same period in 2015.
A reconciliation of GAAP net loss to non-GAAP net loss is presented below under "Non-GAAP Financial Measures."
2016 Financial Guidance
Juno expects 2016 cash burn, excluding cash inflows or outflows from business development activities, to be between $220 million and $250 million.
Operating burn estimated to be between $170 million and $195 million.
Capital expenditures estimated to be between $40 million and $55 million, the vast majority of which are related to one-time infrastructure build-outs.

On May 09, 2016 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the first quarter of 2016 and provided a corporate update on its priorities for 2016 (Press release, Apricus Biosciences, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166289 [SID:1234512311]). Apricus will hold a previously announced webcast this morning at 8:00 am PDT with Edward D. Kim, M.D., a member of the Company’s Scientific Advisory Board and a Vitaros clinical investigator, to discuss the Vitaros opportunity as part of the Company’s corporate activities concurrent with the American Urological Association’s 2016 Annual Meeting, May 6 – 10 in San Diego. Please join the webcast at www.apricusbio.com to view the presentation slides or, to participate by telephone, dial (877) 841-3961 (Domestic) or (201) 689-8589 (International). The conference ID number is 13633850.

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"In March, we sharpened our focus on growth of the Vitaros brand, as we streamlined our organization in an effort to align our corporate strategy and our financial resources with the goal of achieving profitability in 2017," stated Richard W. Pascoe, Chief Executive Officer. "Importantly, we experienced record Vitaros royalties in Europe in the first quarter of 2016 and we continue to have a productive dialogue with the Food and Drug Administration ("FDA") regarding the Vitaros New Drug Application ("NDA") resubmission content and format. As such, we remain on track to resubmit the NDA for Vitaros U.S. in the third quarter of 2016 with an approval decision expected after a six month review period. Finally, we will continue to work closely with our partners to grow Vitaros revenue by supporting additional regulatory approvals and launches, licensing additional territories, and leveraging our existing partnerships to help ensure Vitaros is actively commercialized in all approved territories."

First Quarter Highlights and Recent Developments

Apricus recently updated its corporate goals to focus on increasing Vitaros’ value through the fostering and expansion of its commercial partnerships, in the U.S. and globally, and strengthening the Company’s financial position. First quarter and recent highlights include:

Closed on a $10 million registered direct offering with certain institutional investors, including existing investors Sarissa Capital and Aspire Capital;
Reported top-line Phase 2b data for fispemifene in symptomatic secondary hypogonadism that failed to achieve statistical significance in key clinical benefit endpoints and abandoned further clinical activities surrounding fispemifene; and
Expanded the Company’s exclusive distribution agreement with Ferring Pharmaceuticals to market Vitaros in the United Kingdom as part of the Company’s ongoing initiative to consolidate Vitaros territories with existing partners in an effort to maximize efficiencies and revenue.
2016 Priorities

Apricus is focused on achieving the following key strategic objectives:

Vitaros* (alprostadil)

Continue implementation of the U.S. regulatory approval strategy to address the safety and manufacturing issues raised by the FDA in the original Vitaros NDA submission, with an NDA resubmission on target for the third quarter of 2016;
Continue to support the Company’s ex-U.S. partners’ efforts to increase revenue in countries where partners have launched Vitaros, seek solutions to ensure that Vitaros is available to patients in every country where it is approved but not currently marketed, support new commercial launches by the Company’s partners and assist the Company’s partners in obtaining additional regulatory approvals in their respective territories; and
Continue to generate the required data in 2016 to support delivery device improvements and related regulatory submission(s) with a priority to support the U.S. NDA resubmission of the refrigerated version of Vitaros.
RayVa (alprostadil)

Complete the formulation development for at-home dosing;
Finalize the Phase 2b study protocol;
Explore Orphan Drug Designation in the U.S. and EU; and
Explore global or regional partnerships prior to initiating the Phase 2b study.
First Quarter Financial Results

Revenue during the quarter ended March 31, 2016 was $0.6 million, compared to revenue of $0.5 million during the first quarter of 2015. Revenue during the quarter ended March 31, 2016 was comprised of $0.4 million in royalty revenues, an increase of $0.3 million or 317% over the quarter ended March 31, 2015. Revenue during the quarter ended March 31, 2015 included $0.4 million in license fee revenue related to the expansion of the Company’s license agreement with Sandoz to commercialize Vitaros in certain Asian and Pacific countries. Basic net loss for the quarter ended March 31, 2016 was $2.5 million, or basic loss per share of $0.05, compared to a net loss of $6.4 million, or $0.13 per share for the first quarter of 2015. Reducing the net loss for the quarter ended March 31, 2016 was a non-cash change in the fair value of the Company’s warrant liability in the amount of $2.6 million.

As of March 31, 2016, cash and cash equivalents totaled $6.9 million, compared to $3.9 million as of December 31, 2015.

2016 Financial Outlook

Early in the second quarter of 2016, Apricus reduced its staff, including the executive team, by approximately 30%, decreased the size of the Board by one member and reduced the Board’s cash compensation. Apricus plans to continue to reduce operating expenses (excluding non-cash stock-based compensation expense and depreciation expense), with a goal of achieving reductions of approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses (excluding non-cash stock-based compensation expense and depreciation expense).

In 2016, Apricus expects to continue to generate cash from milestone or licensing payments and royalty revenues from its partners’ sales of Vitaros. Apricus will also continue to pursue out-licensing opportunities for Vitaros in Asia-Pacific. Apricus’ expenditures will include minimal costs for the preparatory Phase 2b clinical development of RayVa, as well as costs for activities associated with supporting the regulatory approval of Vitaros in the U.S. and the commercialization of Vitaros in Europe.

On May 9, 2016 Flamel Technologies (NASDAQ: FLML) reported its financial results for the first quarter of 2016 (Filing, Q1, Flamel Technologies, 2016, MAY 9, 2016, View Source [SID:1234512418]).

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First Quarter Highlights Include:

· Total revenue for first quarter 2016 was $36.2 million, compared to $32.7 million during the same period last year.

· GAAP net loss for the first quarter was ($6.4) million, or ($0.15) per diluted share, compared to GAAP net income of $11.6 million, or $0.27 per diluted share during the same period last year.

· Adjusted EBITDA was $11.8 million, compared to $12.9 million in the prior year.*

· Adjusted net income for the first quarter was $1.6 million, or $0.04 per diluted share, compared to an adjusted net income of $4.7 million, or $0.11 per diluted share, during the same period last year. *

· Cash and marketable securities at March 31, 2016 were $160.0 million, compared to $144.8 million at December 31, 2015 and $113.2 million at March 31, 2015.

· Special Protocol Assessment (SPA) submitted to the U.S. Food and Drug Administration (FDA) for the once nightly version of Micropump sodium oxybate.

* Non-GAAP financial measure. Descriptions of Flamel’s non-GAAP financial measures are included under the caption "Non-GAAP Disclosures and Adjustments" included within this document and reconciliations of such non-GAAP financial measures to their most closely applicable GAAP financial measures are found in the "Supplemental Information" section within this document.

Michael Anderson, Flamel’s Chief Executive Officer, commented, "We were pleased with our strong revenues of $36.2 million during the first quarter. The entrance of a third competitor to the neostigmine market in December 2015 was less impactful to pricing and share for Bloxiverz during the first quarter than initially anticipated; however, we still expect a decline in market share throughout the year to approximately 30% to 35%. As expected on April 29th, we received FDA approval for our third unapproved marketed drug, Akovaz, which is our formulation of ephedrine sulfate injection. Following launch in the third quarter of this year, Akovaz will provide yet another stream of cash flow to help us continue executing against our strategic plan of advancing our pipeline products and growth through acquisitions, the first of which we made early in the first quarter. We continue to focus on integrating the FSC business and revenues are meeting our expectations. We are particularly excited by physicians’ reception of Karbinal ER, which accounted for the majority of revenues from the FSC product portfolio."

Mr. Anderson continued, "At the end of the first quarter, we submitted our SPA to the FDA for our pivotal trial of Micropump sodium oxybate, which will provide the FDA an opportunity to review our trial protocol and provide feedback. We expect to begin patient registration for our pivotal trial in mid-year 2016. We view sodium oxybate as our most valuable pipeline asset, and will continue to take the necessary steps to ensure the Company returns maximum value to our shareholders."

First Quarter 2016 Results

The Company achieved revenues during the first quarter of 2016 of $36.2 million, compared to $32.7 million during the same period last year. On a GAAP basis, Flamel recorded a net loss of ($6.4) million during the first quarter, or ($0.15) per diluted share, compared to a net income of $11.6 million, or $0.27 per diluted share, for the same period last year. Adjusted net income for the first quarter was $1.6 million, or $0.04 per diluted share, compared to an adjusted net income of $4.7 million, or $0.11 per diluted share, during the same period last year. The decline in adjusted diluted EPS from the previous year was primarily due to higher SG&A resulting from investments made in infrastructure and people in order to execute the Company’s strategic plan. Included in GAAP net loss in the first quarter of 2016 was a $7.9 million charge to its contingent consideration liability resulting from the Company’s reassessment of its long term Éclat revenue forecast. In addition, the Company incurred a foreign currency exchange loss of ($2.9) million, compared to a foreign currency exchange gain of $11.5 million in the prior year quarter. Please see the Supplemental Information section within this document for a reconciliation of adjusted EBITDA, adjusted net income and adjusted diluted EPS to the respective GAAP amounts.

Cash flow from operations was $22.5 million, compared to $25.3 million in the same period last year. Cash and marketable securities at March 31, 2016 were $160.0 million, compared to $144.8 million at December 31, 2015, an increase of $15.2 million.

2016 Revenue and R&D Spending Guidance

The Company is maintaining its full year 2016 revenue guidance of $110 – $130 million and expects the recently acquired FSC products, AcipHex Sprinkle, Karbinal ER, Cefaclor for Oral Suspension and Flexichamber, to contribute revenues in the range of $10 – $15 million. As a result of the multiple clinical trials expected to run throughout 2016, the Company expects research & development expenses to be in the range of $35 – $50 million, up from $25.6 million in 2015.