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Acceleron Announces New Data Presentations at the 58th American Society of Hematology Annual Meeting and Exposition

On November 3, 2016 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases, reported that data from five abstracts on the investigational protein therapeutics, luspatercept and sotatercept, will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held in San Diego, California on December 3-6, 2016 (Press release, Acceleron Pharma, NOV 3, 2016, View Source [SID1234516201]).

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The oral and poster presentations will include data from Phase 2 studies with luspatercept, which is being developed under a global partnership with Celgene for the treatment of myelodysplastic syndromes and beta-thalassemia. The clinical presentations at the conference will include updated information beyond that which is contained in the abstracts now available online on the ASH (Free ASH Whitepaper) conference website.

Oral presentations

Title:
Luspatercept Increases Hemoglobin, Decreases Transfusion Burden and Improves Iron Overload in Adults with Beta-Thalassemia (Abstract #851)
Session: 112. Thalassemia and Globin Gene Regulation: Clinical Advances in Thalassemia
Date: Monday, December 5th
Time: 3:45 p.m. PST (San Diego Convention Center, Room 7AB)

Title:
Phase-2 Study of Sotatercept (ACE-011) in Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia (Abstract #478)
Session: 634. Myeloproliferative Syndromes: Clinical: Clinical Trials with Agents Other Than JAK Inhibitors
Date: Sunday, December 4th
Time: 5:15 p.m. PST (Marriott Marquis San Diego Marina, Marriott Grand Ballroom Salons 8-9)

Poster presentations

Title:
Pharmacokinetics and Exposure-Response of Luspatercept in Patients with Anemia Due to Low- or Intermediate-1-Risk Myelodysplastic Syndromes (MDS): Preliminary Results from Phase 2 Studies (Abstract #1990)
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster I
Date: Saturday, December 3rd
Time: 5:30 – 7:30 p.m. PST (San Diego Convention Center, Hall GH)

Title:
Luspatercept Increases Hemoglobin and Reduces Transfusion Burden in Patients with Low-Intermediate Risk Myelodysplastic Syndromes (MDS): Long-Term Results from Phase 2 PACE-MDS Study (Abstract #3168)
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster II
Date:
Sunday, December 4th
Time: 6:00 – 8:00 p.m. PST (San Diego Convention Center, Hall GH)

Title:
Pharmacokinetics and Exposure-Response of Luspatercept in Patients with Beta-Thalassemia: Preliminary Results from Phase 2 Studies (Abstract #2463)
Session: 112. Thalassemia and Globin Gene Regulation: Poster II
Date: Sunday, December 4th
Time: 6:00 – 8:00 p.m. PST (San Diego Convention Center, Hall GH)

The luspatercept posters and presentation slides will be available in the "Science" section on Acceleron’s website (www.acceleronpharma.com).

About Luspatercept

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-beta) superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase 3 clinical trials are underway to evaluate the safety and efficacy of luspatercept in patients with myelodysplastic syndromes (the "MEDALIST" study) and in patients with beta-thalassemia (the "BELIEVE" study). For more information, please visit www.clinicaltrials.gov.

About Sotatercept

Sotatercept is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-β) superfamily involved in fibrosis, vascular calcification, bone mineral density and late stage erythropoiesis (red blood cell production). Acceleron and Celgene are jointly developing sotatercept as part of a global collaboration. Sotatercept is currently in multiple Phase 2 investigator initiated trials. For more information, please visit www.clinicaltrials.gov.

Insys Therapeutics Reports Third Quarter 2016 Results

On November 3, 2016 Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") reported financial results for the three-month period ended September 30, 2016 (Press release, Insys Therapeutics, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219054 [SID1234516196]).

Highlights of and subsequent to the third quarter of 2016 include:

Total net revenue was $55.2 million, compared to $91.3 million for the third quarter of 2015;
Net income totaled $190,000, or $0.00 per basic and $0.00 per diluted share, compared to net income of $26.1 million, or $0.36 per basic and $0.34 per diluted share, for the third quarter of 2015;
Cash, cash equivalents and investments were $217.2 million as of September 30, 2016; and
Insys received FDA approval for the marketing of SyndrosTM (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol.
"Although Subsys volumes declined in the quarter, we are pleased to have maintained a mid-40% market share and believe the product will continue to provide a solid financial foundation for growth and to support our R&D efforts," said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer of Insys Therapeutics. "We are currently awaiting DEA scheduling of Syndros, our recently FDA approved product for cancer induced nausea and vomiting and anorexia associated with weight loss in AIDS patients. We look forward to launching Syndros, our second commercial product, which we believe has distinct advantages over the current formulation of dronabinol in soft gel capsule. We remain excited about our pipeline and believe that both our spray and cannabinoid platform products will provide opportunities for future growth," he concluded.

Third Quarter 2016 Financial Results

Net revenue for the third quarter of 2016 was $55.2 million compared to $91.3 million for the third quarter of 2015, a decrease of 39.5%. The results reflect a decline in Subsys prescription volumes due to softness in overall demand in the TIRF category, including Subsys, and continued pressure from third-party payers.

Gross margin was 92% for the third quarter of 2016 compared with 92% for the comparable quarter of 2015.

Sales and marketing expense was $16.7 million during the third quarter of 2016, or 30% of net revenue, compared to $19.2 million, or 21% of net revenue, for the third quarter of 2015.

Research and development expense increased to $16.5 million for the third quarter of 2016, compared to $12.3 million for the third quarter of 2015, as we continue to advance the multistage products in our pipeline.

General and administrative expense increased to $17.7 million for the third quarter of 2016, up from $13.7 million for the third quarter of 2015, and included a non-cash equity compensation charge of approximately $4 million in connection with the departure of a former executive.

Net income for the third quarter of 2016 was $190,000, or $0.00 per basic and $0.00 per diluted share, compared to net income of $26.1 million, or $0.36 per basic and $0.34 per diluted share, for the third quarter of 2015. Non-GAAP adjusted net income for the third quarter of 2016 was $5.0 million, or $0.07 per diluted share, compared to non-GAAP adjusted net income of $38.0 million, or $0.50 per diluted share, in the prior-year quarter. The reconciliation of net income to non-GAAP adjusted net income is included at the end of this press release.

Liquidity

The Company had $217.2 million in cash, cash equivalents, and short-term and long-term investments, no debt, and $269 million in stockholders’ equity as of September 30, 2016.

Third quarter 2016 report

On November 3, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first nine months of 2016 (Press release, Innate Pharma, NOV 3, 2016, View Source [SID1234516195]).

Cash, cash equivalents and financial instruments of the Company amounted to €239.6 million at September 30, 2016, including current and non-current financial assets (€243.6 million at June 30, 2016). At the same date, its financial liabilities amounted to €5.6 million (€4.1 million at June 30, 2016).

The consumption of cash, cash equivalents and financial instruments amounted to €4.0 million for the third quarter of 2016. This includes the collection during the period of the research tax credit relating to the year 2015 (€7.0 million) and of €2.0 million relating to finance-leases.

This revenue mainly results from:

€27.2 million resulting from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in April 2015 (€5.9 million for the same period in 2015);
€0.7 million from the collaboration and licensing agreement with Bristol-Myers Squibb corresponding to the recognition of the upfront payment received in July 2011 (€4.4 million from a milestone payment for the same period in 2015).
As a reminder, within the frame of the collaboration and licensing agreement signed with Bristol-Myers Squibb in July 2011, the upfront payment received (€24.9 million, $35.3 million) was recognized in revenue during the expected period of duration of the clinical program in progress at the date of the contract. This upfront payment was entirely recognized as of June 30, 2016.

Regarding the co-development and commercialization agreement with AstraZeneca, the Company recognizes the initial payment of $250 million over the period during which the Company is committed to complete the studies and based on actual expenses incurred. The measurement of progress has been based on actual expenses incurred compared to the total estimated amount of expenses to be incurred for these studies.

Hervé Brailly, Chief Executive Officer of Innate Pharma, commented: "Innate Pharma is pleased to report another period of significant progress, as our core programs continue to advance in the clinic and we are maintaining a solid cash position. Preliminary safety and clinical activity results for IPH4102 have been presented at the world congress of cutaneous lymphomas. These results are encouraging for this wholly-owned program. Recently, our partner Bristol-Myers Squibb reported safety data for lirilumab and we now look forward to the release of efficacy data at the SITC (Free SITC Whitepaper) annual meeting in a few days. Beyond our clinical programs, we have continued to invest in our proprietary preclinical pipeline as we seek to build the Company’s wholly-owned portfolio of programs and improve cancer treatment and clinical outcomes for patients."

Epizyme Provides Update on Execution of Clinical Program and Reports Third Quarter 2016 Financial Results

On November 3, 2016 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported recent progress of the Company’s clinical-stage programs and reported financial results for the third quarter of 2016 (Press release, Epizyme, NOV 3, 2016, View Source [SID1234516187]).

"Throughout 2016, we have made substantial progress toward achieving our vision, which includes advancing the clinical development of tazemetostat and expanding its therapeutic benefit into new indications and treatment settings," said Robert Bazemore, President and Chief Executive Officer, Epizyme. "We are executing on a broad clinical program for tazemetostat based on its early clinical activity and safety profile, and guided by strong scientific rationale. We expect 2017 to be an important year for Epizyme, led by data from the Phase 2 studies in non-Hodgkin lymphoma and genetically defined solid tumors in the first half of the year, and determination of our potential registration pathways beginning mid-year."

Execution of Clinical Programs

Enrollment in Phase 2 Programs in NHL and Solid Tumors Progressing: The Company’s Phase 2 studies of tazemetostat in non-Hodgkin lymphoma (NHL) and genetically defined solid tumors are progressing and continue to enroll patients. Epizyme plans to report efficacy, safety and biomarker data from both studies in the first half of 2017. The Company is also preparing for intended regulatory engagement, beginning first with the United States Food and Drug Administration (FDA) in mid-2017 to determine potential registration paths for its genetically defined solid tumor program in adult patients. In addition, Epizyme is preparing for FDA engagement on its NHL program, also in 2017, to determine potential registration paths in various subtypes of NHL.
Immuno-oncology Combination Study Initiated: The Phase 1b study is evaluating tazemetostat in combination with Tecentriq (atezolizumab), in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Tecentriq is the first and only anti-PD-L1 cancer immunotherapy approved by FDA. This study is being conducted by Genentech, a member of the Roche Group, under Epizyme’s collaboration agreement with Roche.
Front-line Combination Study Initiated: The first study of tazemetostat in the front-line treatment setting has been initiated. The Phase 1b/2 study is evaluating tazemetostat in combination with R-CHOP, a chemotherapy regimen, as a first-line treatment for newly diagnosed elderly, high-risk patients with DLBCL. This study is being conducted under the Company’s collaboration with the Lymphoma Study Association.
Mesothelioma Study Initiated: Patient enrollment is underway in Epizyme’s global Phase 2 study evaluating tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. This study marks the expansion of tazemetostat development as a monotherapy into a new cancer indication.
CRADAs Established with NCI on Tazemetostat and Pinometostat: Epizyme recently entered into separate Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI) to evaluate tazemetostat in clinical trials in multiple cancer indications and to evaluate Epizyme’s novel DOT1L inhibitor, pinometostat, in multiple combination regimens. These CRADAs further expand the clinical evaluation of tazemetostat in both adults and children, while also exploring the potential for pinometostat as a combination therapy for certain kinds of acute leukemia.
Collaboration Established with Foundation Medicine: Epizyme entered into a collaboration agreement with Foundation Medicine, Inc. to support patient identification and enrollment for Epizyme’s ongoing Phase 2 clinical trial of tazemetostat in patients with NHL. Foundation Medicine’s SmartTrials Precision Enrollment Program and FoundationOne Heme panel will assist in identifying a population of individuals with NHL who harbor EZH2 mutations, which constitute specific cohorts in the Epizyme trial.
Strengthening of Epizyme Team

The Company made two, recent key hires to prepare for the intended regulatory engagement and determination of potential registration pathways in 2017. Pamela Strode was appointed to the position of Vice President of Regulatory Affairs and Quality Assurance, and Ray Mankoski, M.D., Ph.D. was appointed as Vice President of Medical Affairs.
Third Quarter 2016 Financial Results and Guidance

Cash Position: Cash, cash equivalents and marketable securities were $263.3 million as of September 30, 2016, as compared to $208.3 million as of December 31, 2015.
Revenue: Collaboration revenue was $6.6 million and $7.5 million for the three and nine months ended September 30, 2016, respectively, compared to $0.4 million and $2.0 million for the three and nine months ended September 30, 2015, respectively. The increase was driven predominantly by the recognition of the $6.0 million milestone earned upon GlaxoSmithKline’s (GSK) initiation of patient dosing in a Phase 1 clinical trial of GSK3326595, a PRMT5 inhibitor invented by Epizyme and licensed to GSK. GSK holds worldwide rights to the compound, and Epizyme may receive significant additional payments from GSK if future milestones are met for the program, plus up to double digit royalties on worldwide net sales should this product candidate progress through the clinic to commercialization.
R&D Expenses: Research and development (R&D) expenses were $23.9 million and $63.1 million for the three and nine months ended September 30, 2016, respectively, compared to $16.8 million and $94.4 million for the three and nine months ended September 30, 2015, respectively. The increase in R&D expenses for the three months ended September 30, 2016, is primarily due to the expansion of the tazemetostat clinical development program, increased spending on tazemetostat preclinical activities, and increased discovery and spending on high-priority, earlier-stage programs. The period-over-period decrease from the nine months ended September 30, 2015 was driven by the inclusion of the $40.0 million payment to Eisai for the reacquisition of the tazemetostat worldwide rights, excluding Japan, in R&D expenses in the first quarter of 2015. The Company expects that research and development expenses will continue to increase in the fourth quarter of 2016.
G&A Expenses: General and administrative (G&A) expenses were $7.5 million and $20.8 million for the three and nine months ended September 30, 2016, respectively, as compared to $6.7 million and $17.9 million for the three and nine months ended September 30, 2015, respectively. The increase is primarily due to the staffing of key leadership roles in the first half of 2016. G&A expenses were flat compared to the second quarter of 2016, and we expect G&A expenses to remain relatively constant through the fourth quarter of 2016.
Net Loss: Net loss was $24.3 million and $75.2 million for the three and nine months ended September 30, 2016, respectively, compared to a net loss of $23.1 million and $110.2 million for the three and nine months ended September 30, 2015, respectively.
Financial Guidance: Epizyme reiterates its belief that its cash, cash equivalents and marketable securities of $263.3 million as of September 30, 2016 will be sufficient to fund the Company’s planned operations into at least the second quarter of 2018.

AMAG Pharmaceuticals Reports Third Quarter 2016 Financial Results and Provides Corporate Update

On November 3, 2016 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the third quarter ended September 30, 2016. Total revenue for the third quarter of 2016 increased approximately 50% to $143.8 million (Filing, Q3, AMAG Pharmaceuticals, 2016, NOV 3, 2016, View Source [SID1234516181]). This increase was driven by record sales of Makena and the recognition of a full quarter of revenue from Cord Blood Registry (CBR), which was acquired by AMAG on August 17, 2015. The company reported third quarter 2016 operating income of $38.8 million and net income of $16.2 million. Non-GAAP adjusted EBITDA for the third quarter of 2016 increased to $76.2 million1, or 44%, versus the same period in 2015. Non-GAAP net income for the third quarter of 2016 increased to $61.8 million1, or 46%, versus the same period in 2015.

"We executed well against our key priorities in the third quarter, delivering strong financial results and hitting key milestones in our next-generation development programs," stated William Heiden, AMAG’s chief executive officer. "Our Makena subcutaneous auto-injector program is on-track for an sNDA filing in the second quarter of next year and the Feraheme sNDA submission seeking approval of a broader label has been accelerated to mid-year 2017."

"We have updated the company’s financial guidance based on our fourth quarter expectations of continued strong top and bottom line performance, building on our successes achieved in the third quarter," Mr. Heiden continued.

Third Quarter 2016 and Recent Business Highlights
• Delivered total revenue of $143.8 million in the third quarter of 2016, compared with $96.2 million in the same period last year. This increase of approximately 50% was driven by record sales of Makena and the recognition of a full quarter of revenue from CBR.
• Achieved Makena sales of $93.4 million in the third quarter of 2016, compared with $65.2 million in the same period last year. Makena’s robust sales growth of 43% was driven exclusively by an increase in volume. This growth resulted in Makena market share of 41%, four percentage points over the second quarter of 2016 and an 11 percentage point gain year-to-date.
• Generated 1.8% growth to $29.9 million1 in non-GAAP revenue from CBR over the second quarter of 2016 due to improved net revenue per new customer. In addition, enrollments were higher versus the second quarter of 2016.
• Reported $22.3 million in Feraheme sales, maintaining market share in the intravenous iron market, which experienced a slight decline in the third quarter of 2016.

See summaries of GAAP to non-GAAP adjustments at the conclusion of this press release.

• Achieved key milestones in the Makena subcutaneous auto-injector development program. The company dosed first subjects in both the definitive pharmacokinetic study and comparative pain study. Data from each of these studies is intended to support the supplemental new drug application (sNDA) that the company plans to file with the Food and Drug Administration (FDA) in the second quarter of 2017.
• Continued to enroll patients more rapidly than expected in the company’s head-to-head, Phase 3 clinical trial evaluating Feraheme in adults with iron deficiency anemia (IDA). The company is seeking to broaden Feraheme’s current label beyond its chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment. The timeline to anticipated approval has been shortened by approximately six months as a result of the trial’s rapid enrollment, which has accelerated the company’s expected sNDA submission date to mid-2017.
• Generated an increase of $147.7 million in cash and investments in the first nine months of 2016 to $614.1 million, net of $20.0 million utilized to repurchase the company’s common stock and $13.1 million to repay debt.

Third Quarter Ended September 30, 2016 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the third quarter of 2016 were $143.8 million, compared with $96.2 million in the third quarter of 2015. This increase is related to record sales of Makena and the recognition of a full quarter of revenue from CBR, which was acquired by AMAG on August 17, 2015. Net product sales of Makena increased to $93.4 million in the third quarter of 2016, compared with $65.2 million in the same period last year. This 43% growth in Makena sales was primarily driven by the successful launch of the single-dose, preservative-free formulation and strong growth in the company’s Makena @Home program. Sales of Feraheme and MuGard totaled $22.4 million in the third quarter of 2016, compared with $23.8 million in the third quarter of 2015. Service revenue from CBR totaled $28.0 million in the third quarter of 2016, as compared to $7.2 million in the third quarter of 2015.

Total costs and expenses, including costs of product sales and services, totaled $105.0 million for the third quarter of 2016, compared with $97.5 million for the same period in 2015. The increase in operating expenses in 2016 was related to: (i) higher research and development expenses for the company’s next generation development programs, (ii) higher selling, general and administrative expenses due to the recognition of a full quarter of CBR-related expenses, and (iii) higher non-cash amortization of the Makena intangible asset. These increases were partially offset by expenses in the third quarter of 2015 that did not recur in 2016 related to an upfront payment for AMAG’s exclusive option to acquire rights to a development stage asset to treat severe preeclampsia (Velo) and CBR-related acquisition costs.

Third quarter 2016 operating income totaled $38.8 million, compared with a $1.4 million loss in the third quarter of last year. The company reported net income of $16.2 million, or $0.47 per basic share and $0.43 per diluted share, for the third quarter of 2016, compared with a net loss of $20.6 million, or $0.62 per basic and diluted share, for the same period in 2015.

Balance Sheet Highlights
The company’s cash, cash equivalents and investments increased by $147.7 million in the first nine months of 2016 to approximately $614.1 million, net of $20.0 million utilized to repurchase the company’s common stock and $13.1 million to repay debt. Total debt (principal amount outstanding), including $200 million of convertible debt, was approximately $1.03 billion as of September 30, 2016. For the 12 months ended September 30, 2016, sales of Makena exceeded $300 million, triggering a $100 million milestone that will be paid to former Lumara Health shareholders in the fourth quarter of 2016.

"In the third quarter, we once again generated strong cash flow as a result of our solid commercial execution and operating discipline," stated Ted Myles, chief financial officer of AMAG. "We are now in an even better position to capitalize on acquisition or licensing opportunities that would diversify and expand our product portfolio."
Financial Results (Non-GAAP Basis)1,2
Non-GAAP revenues totaled $145.8 million in the third quarter of 2016, up from $103.5 million in the third quarter of 2015. Non-GAAP CBR revenue totaled $29.9 million in the third quarter of 2016, compared with $14.5 million in the same period in 2015. CBR’s financial results for the third quarter of 2015 include only a portion of the quarter, as AMAG purchased CBR on August 17, 2015. The difference between GAAP and non-GAAP revenue for the quarter represents purchase accounting adjustments related to CBR deferred revenue.

Total non-GAAP costs and expenses, including costs of product sales and services, totaled $69.6 million in the third quarter of 2016, compared with total non-GAAP costs and expenses of $50.6 million in the same period in 2015. Non-GAAP adjusted EBITDA for the third quarter of 2016 was $76.2 million, compared with $52.8 million for the same period in 2015.

The company generated third quarter 2016 non-GAAP net income of $61.8 million, or $1.81 per non-GAAP basic share and $1.78 per non-GAAP diluted share. In the third quarter of 2015, non-GAAP net income totaled $42.3 million, or $1.27 per non-GAAP basic share and $1.02 per non-GAAP diluted share. Non-GAAP diluted shares for the third quarter of 2016 do not include 7.4 million of potentially dilutive shares from the convertible notes, as the stock price was below the convertible notes’ exercise price.

Updated 2016 Financial Guidance Range3

2016 GAAP Guidance

2016 Non-GAAP Guidance
$ in millions

Previous
Updated

Previous
Updated
Makena sales

$310 – $340
$330 – $340

$310 – $340
$330 – $340
Feraheme and MuGard sales

$95 – $105
$95 – $105

$95 – $105
$95 – $105
CBR revenue

$98 – $108
$98 – $108

$115 – $125
$115 – $125
Total revenue

$503 – $553
$523 – $553

$520 – $570
$540 – $570

Net income

$0 – $30
$3 – $23

$195 – $225
$200 – $220
Operating income

$93 – $123
$98 – $118

N/A
N/A
Adjusted EBITDA

N/A
N/A

$255 – $285
$260 – $280