On February 17, 2016 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company with a diverse portfolio of products in the areas of maternal health, anemia management and cancer supportive care, reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2015 (Filing, 8-K, AMAG Pharmaceuticals, FEB 17, 2016, View Source [SID:1234509079]).

"2015 was a pivotal year for AMAG as we drove revenue growth of Makena and Feraheme, expanded our presence in maternal health through the acquisition of Cord Blood Registry and made an investment in a promising therapy for the potential treatment of severe preeclampsia," said William Heiden, AMAG’s chief executive officer. "Growing revenues and integrating these transactions, combined with advancing our next generation programs for Makena and Feraheme, have positioned us well for continued strong growth."

Full Year 2015 Business Highlights:

· Increased net product sales of Makena by 52% to $251.6 million, compared with pro forma net product sales of $165.8 million(2) in 2014. This growth in sales was driven by a 56% increase in volume as more at-risk pregnant women were treated with Makena.

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· Made progress toward commercialization of a single-dose, preservative-free formulation of Makena. The company responded to questions contained in the FDA’s complete response letter in November 2015 and anticipates an approval of its manufacturing supplement in the first quarter of 2016 with commercial launch in the second quarter of 2016.

· Advanced the development of the next generation program for Makena with an auto-injector device for subcutaneous administration of Makena through a partnership with Antares Pharma, Inc., an experienced drug device company.

· Expanded the maternal health portfolio through the acquisition of Cord Blood Registry (CBR), the world’s largest private newborn stem cell bank serving pregnant women and their families, and the purchase of an option to acquire worldwide rights to an orphan drug candidate being developed for severe preeclampsia.

· Returned Feraheme (ferumoxytol) to growth in the second half of the year, increasing sales by 5% to $88.5 million in 2015, compared with $84.4 million in 2014.(3)

(1) See summaries of non-GAAP adjustments for the three and twelve months ended December 31, 2015 and 2014 at the conclusion of this press release.
(2) Unaudited. Includes net product sales of Makena as though Lumara Health had been acquired at the beginning of 2014. Lumara Health was purchased on November 12, 2014.

· Initiated start-up activities for a head-to-head, Phase 3 clinical trial evaluating the safety of Feraheme compared to Injectafer (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA). This study is intended to support an sNDA filing to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment.

Fourth Quarter Ended December 31, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues for the fourth quarter of 2015 were $108.7 million, compared with $53.3 million for the same period in 2014. Net product sales of Makena were $67.4 million in the fourth quarter of 2015, compared with $22.5 million(4) in the same period last year. Sales of Feraheme and MuGard totaled $23.5 million in the fourth quarter of 2015, compared with $24.5 million in the fourth quarter of 2014, which included a favorable $1.8 million release of product return reserves. Service revenue from CBR totaled $17.0 million in the fourth quarter of 2015.

Total costs and expenses for the fourth quarter of 2015 were $86.1 million, compared with $56.6 million for the same period in 2014. The increase in costs and expenses was primarily due to higher costs associated with managing the company’s expanded portfolio and infrastructure following the acquisitions of Lumara Health in November 2014 and CBR in August 2015.

The company reported operating income of $22.7 million and net income of $7.2 million, or $0.21 per basic share and $0.20 per diluted share, for the fourth quarter of 2015, compared with an operating loss of $3.4 million and net income of $143.0 million, or $5.98 per basic share and $4.67 per diluted share, for the same period in 2014. In the fourth quarter of 2014, the company recognized a non-cash income tax benefit of $153.2 million associated with the release of reserves on certain tax attributes (i.e., net operating losses) as a result of the Lumara Health transaction. The weighted average diluted shares used in calculating diluted net income per share in 2015 and 2014 followed the if-converted method of accounting for the convertible debt.

Financial Results (Non-GAAP Basis)(1),(5)

Non-GAAP revenues totaled $120.6 million, up from $51.0 million in the fourth quarter of 2014. Non-GAAP CBR revenue totaled $28.8 million in the fourth quarter of 2015. The difference between GAAP and non-GAAP revenue for CBR represents purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $59.2 million resulting in a gross margin of 92% and adjusted EBITDA margin of 51% for the fourth quarter of 2015. This compares to costs and expenses of $36.4 million in the same period of 2014, which resulted in a gross margin of 89% and adjusted EBITDA margin of 29%. Non-GAAP adjusted EBITDA for the fourth quarter of 2015 was $61.3 million, compared with $14.5 million for the same period in 2014.

(3) Excludes a favorable $1.8 MM release of product return reserves in 2014.
(4) AMAG purchased Lumara Health maternal health business on November 12, 2014.
(5) See share count reconciliation at the conclusion of this press release.

After deducting cash interest expense, the company generated fourth quarter 2015 non-GAAP cash earnings of $46.5 million, or $1.34 per non-GAAP basic share and $1.12 per non-GAAP diluted share. In the fourth quarter of 2014, non-GAAP cash earnings totaled $10.2 million, or $0.33 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share for the fourth quarter of 2015 includes the impact of the convertible debt and related bond hedge and warrants.

Full Year Ended December 31, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues in 2015 were $418.3 million, compared with $124.4 million in 2014. This increase is primarily related to the addition of Makena in November 2014 and CBR in August 2015, which contributed $251.6 million and $24.1 million, respectively, in product revenue to the 2015 results. In addition, the company recognized $52.3 million of collaboration revenue in 2015 related to the company’s ex-US ferumoxytol marketing agreement with Takeda Pharmaceutical Company Limited, compared with $14.4 million of collaboration revenue in 2014. The marketing agreement was terminated in 2015, resulting in the recognition of all previously deferred revenue.

Net income totaled $32.8 million in 2015, compared with $135.8 million in 2014. Basic net income per share was $1.04, compared with $6.06 in 2014. Diluted net income per share was $0.93 in 2015, compared with $5.45 in 2014. In 2014, the company recognized a non-cash income tax benefit of $153.2 million associated with the release of reserves on certain tax attributes (e.g., net operating losses) as a result of the Lumara Health transaction. The weighted average diluted shares used in calculating diluted net income per share in 2015 and 2014 followed the if-converted method of accounting for the convertible debt.

Financial Results (Non-GAAP Basis)(1),(5)

Non-GAAP revenues totaled $397.4 million in 2015, up from $116.2 million in 2014. Non-GAAP CBR revenue totaled $43.3 million since the acquisition in August 2015. Non-GAAP adjusted EBITDA totaled $213.4 million in 2015, compared with $14.3 million in 2014. After deducting cash interest expense, the company generated non-GAAP cash earnings of $173.7 million in 2015, or $4.43 per non-GAAP diluted share. In 2014, non-GAAP cash earnings totaled $7.7 million, or $0.30 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share in 2015 included the impact of the convertible debt and related bond hedge and warrants.

Balance Sheet Highlights

As of December 31, 2015, the company’s cash and investments totaled approximately $466.3 million and total debt (face value) was approximately $1.0 billion.

"The two transformative acquisitions that we completed in the past eighteen months fueled our significant top- and bottom-line growth in 2015, resulting in adjusted EBITDA of more than $210 million in 2015," said Frank Thomas, AMAG’s president and chief operating officer. "These strong cash flows, combined with more than $460 million in cash and investments on the balance sheet, positions us well for future acquisitions that will allow us to leverage our commercial organization and add new, innovative products to our portfolio to drive future growth."

2016 Goals

The company’s goals for 2016 include the following:
· Drive significant net product sales growth (+40%) over 2015

· Grow non-GAAP adjusted EBITDA to more than $255 million

· Continue to execute on the Makena next generation development program, including:

· Receiving a favorable decision from the FDA in 1Q 2016 for the single-dose, preservative-free formulation of Makena with a 2Q 2016 commercial launch

· Completing chemistry, manufacturing and controls (CMC) and pilot pharmacokinetics (PK) work to support the initiation of a bio-equivalence study for the Makena subcutaneous auto injecter by the end of 2016

· Enroll patients in a head-to-head Phase 3 clinical trial in 2016 evaluating the safety of Feraheme compared to Injectafer in adults with IDA

· Complete preclinical work and initiate clinical program for severe preeclampsia Velo option

· Further expand the company’s product portfolio through acquisitions or in-licensing of products or companies

Use of Non-GAAP Financial Measures

AMAG has presented certain non-GAAP financial measures, including non-GAAP revenue, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization), non-GAAP net income, or

(6) See reconciliation of 2016 financial guidance of non-GAAP CBR revenue, non-GAAP adjusted EBITDA and non-GAAP cash earnings at the conclusion of this press release.

cash earnings, non-GAAP diluted net income, or cash earnings, per share, and non-GAAP weighted average diluted shares. These non-GAAP financial measures exclude certain amounts, revenue, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

On February 17, 2016 bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported treatment of the first patient in a Phase 1 study of its product candidate bb2121 in patients with relapsed/refractory multiple myeloma (Filing, 8-K, bluebird bio, FEB 17, 2016, View Source [SID:1234509086]). bb2121 is a chimeric antigen receptor T cell (CAR T) therapy targeting B cell maturation antigen (BCMA), and bluebird bio is developing bb2121 in collaboration with Celgene Corporation. bluebird bio also announced today that Celgene has exercised its option to exclusively license bb2121, under the terms of the collaboration agreement between the two companies.

"bb2121 is bluebird bio’s first oncology program to enter the clinic, and the treatment of this first patient marks an important milestone for us as we build a broad, fully integrated T cell immunotherapy franchise," said Nick Leschly, chief bluebird. "We are pleased that Celgene has exercised their option to license bb2121. We believe our combined manufacturing, development and commercial expertise will enable us to rapidly advance bb2121 through clinical trials."

"Despite many recent advances in the field, multiple myeloma remains incurable, with almost all patients becoming refractory to therapy eventually," said James N. Kochenderfer, M.D., National Cancer Institute, an investigator for the CRB-401 study. "BCMA is one of the most exciting targets in multiple myeloma, and we are eager to explore the potential of bb2121 to become an important new treatment option for patients living with multiple myeloma."

bluebird bio and Celgene amended and restated their collaboration agreement in June 2015 to focus on developing product candidates targeting BCMA during a three-year collaboration term. By exercising its exclusive option under the terms of the agreement, Celgene will be responsible for worldwide development and commercialization of bb2121 after Phase 1. bluebird bio is responsible for the development of bb2121 through the completion of the CRB-401 Phase 1 study and has an option to share in the development, promotion and profits in the United States. bluebird bio will receive a $10 million option exercise payment from Celgene, and bluebird bio is also eligible to receive specified development and regulatory and commercial milestone payments and royalty payments on net sales.

About the CRB-401 Study

The primary objective of the CRB-401 study is to evaluate the maximum tolerated dose of bb2121 and determine the recommended Phase 2 dose. The secondary objective is patient response, measured using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. The first portion of the study includes a dose-escalation phase in which cohorts of patients will receive ascending doses of bb2121 to determine the maximum tolerated dose and establish a recommended Phase 2 dose. The second portion of the study is a dose expansion phase where patients will receive bb2121 to further evaluate the safety, tolerability and clinical activity at the recommended Phase 2 dose.

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On February 08, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its consolidated financial results for the year ended December 31, 2015 (Press release, Innate Pharma, FEB 17, 2016, View Source [SID:1234509346]). The consolidated financial statements are attached to this press release.

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Hervé Brailly, Chief Executive Officer and co-founder of Innate Pharma, commented: "2015 was a very important year for Innate Pharma. We signed a landmark co-development and commercialization agreement in April with AstraZeneca which we can leverage on to bring us to the next steps of our corporate progress, i.e. late stage drug development and marketing. The initial payment also gives us financial flexibility which we are using to expand the base of the Company. We are growing the organization, hiring new talent and investing in our proprietary clinical and preclinical pipeline to ensure the future growth of Innate. One tangible move in this direction was the recent acquisition of CD39, a new, preclinical first-in-class checkpoint inhibitor program, and our investment in innovative technologies such as the NK bispecific engagers illustrated by the recently announced collaboration with Sanofi.

As we await important clinical data for lirilumab, we intend to continue to broaden and consolidate our unique positioning in the very promising area of immuno-oncology".

On February 16, 2016 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the fourth quarter and full year ended December 31, 2015 (Press release, CTI BioPharma, FEB 16, 2016, View Source;p=RssLanding&cat=news&id=2139676 [SID:1234509071]).

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"While we were disappointed and surprised by the FDA’s decision to place pacritinib’s IND on full clinical hold, our priority and sense of purpose has always been to do what is best for patients," said James A. Bianco, M.D., president and chief executive officer of CTI BioPharma."There remains a significant unmet medical need in the treatment of myelofibrosis, especially for those with low platelet counts. We continue to see the potential of pacritinib to help this patient population and we are committed to resolving the FDA’s concerns in order to identify a path forward. Additionally, we plan to define the registration path for tosedostat, which recent interim data from a cooperative group study showed the potential therapeutic utility of this oral aminopeptidase inhibitor for older patients with AML and high-risk MDS. We ended the year with a strong financial position that we believe will enable us to achieve our goals in 2016 and beyond."

Recent Highlights

Pacritinib

In January 2016, CTI BioPharma announced the completion of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. CTI BioPharma and Baxalta Incorporated (Baxalta) are seeking U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/µL). In February 2016, the FDA placed pacritinib’s investigational new drug application (IND) on a full clinical hold and CTI BioPharma subsequently withdrew its NDA.

In December 2015, researchers presented results from a new analysis of the pivotal Phase 3 trial, PERSIST-1, evaluating pacritinib versus best available therapy, excluding treatment with JAK2 inhibitors (BAT), in patients with myelofibrosis. Data examining patient outcomes across baseline demographic factors that are associated with prognosis showed that treatment with pacritinib resulted in consistent rates of spleen volume reduction and control of disease-related symptoms across all intermediate or high-risk myelofibrosis subgroups.

Tosedostat

In December 2015, researchers presented an update on results from an investigator-sponsored Phase 2 trial of tosedostat – CTI BioPharma’s investigational oral selective aminopeptidase inhibitor – in elderly patients with either primary (de novo) acute myeloid leukemia (AML) or secondary AML. The data showed a complete response (CR) rate of 48.5 percent with tosedostat in combination with low dose cytarabine/Ara-C (LDAC) – 33 percent of these patients were still responding after a median of 506 days.

In November 2015, CTI BioPharma announced that the United Kingdom’s National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group has chosen to advance tosedostat to the second stage of a randomized clinical trial of low-dose cytarabine plus or minus tosedostat in older patients with AML or high risk myelodysplastic syndrome (MDS). The AML Less Intensive (LI-1) trial is designed as a "Pick-a-Winner" trial to be able to simultaneously test a number of promising agents added to standard therapy with low-dose cytarabine in older patients with AML or MDS who are unfit for standard aggressive induction therapy. Nine regimens have been tested in the Pick-a-Winner program, of which only four, including tosedostat, have passed the initial hurdle for progression (which requires evidence of an improvement in remission rate with acceptable safety). CTI BioPharma plans to discuss potential approval pathways with regulators in the U.S. and EU in 2016.

Fourth Quarter and Full Year Financial Results

Total revenues for the fourth quarter and the full year ended December 31, 2015, were $11.3 million and $16.1 million, respectively, compared to $17.8 million and $60.1 million for the same periods in 2014. The decrease in total revenue for the full year ended December 31, 2015, as compared to December 31, 2014, is primarily due to recognition of milestone payments in 2014, specifically a $20.0 million development milestone payment received from Baxalta for completion of enrollment in the PERSIST-1 Phase 3 clinical trial of pacritinib and $17.3 million from an upfront payment under the PIXUVRI collaboration agreement with Servier. Net product revenues of PIXUVRI for the fourth quarter and the full year ended December 31, 2015, were $1.1 million and $3.5 million, respectively, compared to $2.5 million and $6.9 million for the same periods in 2014. The decrease in net product sales for the full year ended December 31, 2015, as compared to December 31, 2014, was primarily related to the pricing and volume variances between the periods as well as the decline in average exchange rate of the euro for our euro-denominated sales.

The non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the fourth quarter and full year ended December 31, 2015, was $24.4 million and $101.8 million, respectively, compared to non-GAAP operating loss of $36.2 million and $66.0 million for the same periods in 2014. The GAAP operating loss for the fourth quarter and full year ended December 31, 2015, was $26.2 million and $116.7 million, respectively, compared to a GAAP operating loss of $39.4 million and $86.2 million for the same period in 2014. The increase in operating loss for the full-year ended December 31, 2015, as compared to December 31, 2014, is predominantly associated with the Phase 3 development program for pacritinib and the PIXUVRI post-authorization Phase 3 trial as well as the milestone and the upfront payments received in 2014 mentioned above. Non-cash share-based compensation expense for the fourth quarter and full year ended December 31, 2015, was $1.8 million and $14.8 million, respectively, compared to $3.2 million and $20.2 million for the same periods in 2014. For information on CTI BioPharma’s use of the aforementioned non-GAAP measure and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the fourth quarter of 2015 was $28.8 million, or $(0.13) per share, compared to a net loss of $44.2 million, or ($0.27) per share, for the same period in 2014. Net loss for the full year of 2015 was $122.6 million, or $(0.65) per share, compared to a net loss of $96.0 million, or $(0.65) per share, for the same period in 2014.

As of December 31, 2015, cash and cash equivalents totaled $128.2 million, compared to $70.9 million as of December 31, 2014.

On February 16, 2016 Varian Medical Systems (NYSE: VAR) reported its ARIA oncology information system and Eclipse treatment planning software have been named "2015/2016 Category Leader" in the "Best in KLAS: Software and Services Report" by KLAS, an independent research firm specializing in monitoring and reporting on the performance of healthcare vendors (Press release, InfiMed, FEB 16, 2016, View Source [SID:1234509075]).

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In use in some 3,200 cancer treatment centers around the world, ARIA was named the "2015/2016 Category Leader" for Oncology software. ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology. The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up.

ARIA users shared these comments posted on KLASresearch.com: a director stated, "ARIA is a great solution. It works well for both medical and radiation oncology." While a CIO shared these comments about the ARIA solution: "ARIA is tightly linked with the functionality of our linear accelerator, and that is incredible. That connection is what makes ARIA very valuable to our oncologists and radiologists. The linear accelerator is controlled through the software, so the charting and things we do with patients become almost invisible. All the documentation we have to do is automatically put in to the system. On the oncology side, all the formulas are streamlined. Doctors don’t have to look for a lot of things. There are a lot of customized fields doctors can set up."

For more information on ARIA, visit View Source

Named a "2015/2016 Category Leader" for Treatment Planning software for the third year in a row, the market and technology-leading Eclipse software is in use at some 3,400 cancer treatment centers around the world. The software creates an optimized radiotherapy treatment plan based on a physician’s dose instructions, and information about the size, shape and location of the tumor to be treated with radiation. The Eclipse software incorporates unique features such as RapidPlan knowledge-based planning, which makes it easier and faster to plan sophisticated cancer treatments like intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and RapidArc radiotherapy.

In comments posted on KLASresearch.com, a vice president who uses Eclipse said: "We really like Eclipse and feel it is the very best treatment planning software out there." A physicist using Eclipse stated: "We find it very easy to create good, efficient dose management using the system."

For more information on Eclipse, visit View Source

"These rankings acknowledge the hard work the Varian team has done. Working closely with oncology clinicians and administrators has allowed us to understand their needs, enhance the ARIA information system and Eclipse software, and provide the best-in-class tools for fighting cancer," said Kolleen Kennedy, president of Varian’s Oncology Systems business.

The 2015/2016 Best in KLAS report, published at the end of January, ranks healthcare vendors and their solutions by the professionals who use them—healthcare providers. For a full list of Best in KLAS winners, Global (Non-U.S.) Best in KLAS winners, and Category Leaders, visit View Source