On November 3, 2015 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the third quarter ending Sept. 30, 2015, and provided a clinical update (Press release, Endocyte, NOV 3, 2015, View Source [SID:1234507923]).

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"Our Phase 1 dose escalation trials of the folate receptor (FR)- and prostate-specific membrane antigen (PSMA)-targeted tubulysin SMDCs, EC1456 and EC1169, continue to progress well. Both SMDCs are being dose escalated on two different schedules," said Ron Ellis, Endocyte’s president and chief executive officer. "Once we have determined the maximum tolerated dose and optimal schedule for each SMDC, we look forward to moving into expansion cohorts where we will evaluate these SMDCs specifically in receptor-positive patients among different tumor types, both as single agents and in combination with standard of care drugs."

Earlier in the third quarter, Endocyte announced the final results from the Phase 2b TARGET trial evaluating its SMDC vintafolide in combination with docetaxel in patients with FR positive recurrent non-small cell lung cancer (NSCLC) at the World Conference on Lung Cancer in Denver, Colorado. Vintafolide plus docetaxel improved overall survival (OS) by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of FR, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). This data is in line with earlier findings from the study of improved progression free survival and higher overall response rates. Final safety results were also consistent with those previously reported.

Third Quarter 2015 Financial Results

Endocyte reported a net loss of $10.0 million, or $0.24 per basic and diluted share, for the third quarter of 2015, compared to a net loss of $5.7 million, or $0.14 per basic share and diluted share, for the same period in 2014. The third quarter of 2014 included the recognition of $3.9 million of revenue related to the former collaboration with Merck.

Research and development expenses were $6.6 million for the third quarter of 2015, compared to $5.7 million for the same period in 2014. The increase in research and development expense was primarily attributable to an increase in expenses for the EC1456 and EC1169 dose escalation trials, the drug manufacturing expense of EC1456, and an increase in compensation expense, including noncash stock compensation, partially offset by the decrease in manufacturing expenses of etarfolatide, our folate-targeted companion molecular imaging agent to vintafolide and EC1456.

General and administrative expenses were $3.8 million for the third quarter of 2015, compared to $4.0 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in legal and patent fees, slightly offset by an increase in compensation expense, including noncash stock compensation.

Cash, cash equivalents and investments were $180.3 million at September 30, 2015, compared to $211.1 million at September 30, 2014, and $206.8 million at December 31, 2014.

Financial Expectations

The Company updated its 2015 financial expectations and now anticipates that its 2015 year-end cash balance will be approximately $170 million.

On November 3, 2015 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology reported new preclinical data showing that a dendritic-cell targeting lentiviral vector from its ZVex immunotherapy platform administered with G100, which contains a potent synthetic TLR4 agonist, synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models (Press release, Immune Design, NOV 3, 2015, View Source [SID:1234507922]). These data are being presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference, National Harbor, Maryland, November 4-8, 2015.

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"These findings further illustrate the potential of ZVex-based product candidates and G100 to play an important role in the emerging field of cancer immunotherapy, especially in potential combination therapies with immune checkpoint inhibitors," said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. "Mechanistically, it is generally believed that the generation of tumor-specific CD8 T-cells can improve the clinical efficacy of checkpoint inhibitors, especially in patients with insufficient T-cell responses. These preclinical data provide a strong rationale for our ongoing and planned clinical trials which combine LV305, CMB305 and G100, agents from our ZVex and GLAAS discovery platforms, with KEYTRUDA and Atezolizumab."

In the presentations, Immune Design scientists present data showing that in the murine B16 melanoma model, intratumoral injection of G100 improves the trafficking of ZVex-induced antigen-specific CD8 T-cells into tumors and induces systemic anti-tumor immunity mediated by antigen spreading. This discovery that Immune Design’s two platforms appear to "pull" T cells (G100) that were "primed" (ZVex agent) into the tumor potentially opens up new possibilities of enhancing the immunotherapy of solid tumors by changing the tumor microenvironment. In addition, combining G100 or a ZVex agent with both anti-PD1 and anti-PDL1 antibodies demonstrated increased efficacy in this experiment. The presentations are entitled "Intratumoral Injections of G100 (synthetic TLR4 agonist) Increases Trafficking of Lentiviral Vector-induced Antigen-specific CD8 T Cells to the Tumor Microenvironment" and "Checkpoint Inhibitors Synergize with Therapeutic Platforms, ZVex and GLAAS by Enhancing Lentiviral Vector-induced Tumor-specific Immunity and Adjuvant-mediated Anti-tumor Efficacy."

These abstracts will be published in the Journal for ImmunoTherapy for Cancer on November 4, 2015, and the posters will be posted on the publications page of the Immune Design website following presentation at the conference.

About G100

G100 is a product candidate generated from the company’s GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like receptor-4 (TLR-4) agonist. G100 is part of Immune Design’s intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor’s preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. A Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In the first eight patients in MCC study, G100 had an acceptable safety profile and the combined therapy of G100 followed by radiation and/or surgery resulted in an objective response rate (ORR) of 50%. A second Phase 1 trial is planned to examine intratumoral administration of G100 with intravenous administration of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with follicular non-Hodgkin’s lymphoma receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions.

About ZVex

ZVex is Immune Design’s discovery platform designed to activate and expand the immune system’s natural ability to create tumor-specific cytotoxic T cells (CTLs) in vivo.

The ZVex delivery system uses a re-engineered virus to carry genetic information of a tumor antigen selectively to dendritic cells (DCs) in the skin. This ultimately results in the creation of CTLs designed to kill tumor cells bearing that same specific tumor antigen.

On November 3, 2015 Genmab reported Interim Report for the Nine Months Ended September 30, 2015 (Press release, Genmab, NOV 3, 2015, View Source [SID:1234507921]).

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Daratumumab granted Priority Review by U.S. Food and Drug Administration (FDA) and accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)

Achieved USD 25 million in milestone payments from Janssen related to the regulatory applications submitted to the FDA and EMA for daratumumab

Regulatory submissions for ofatumumab (Arzerra) as maintenance therapy for relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the EMA and FDA — Priority Review granted by FDA

Entered commercial license agreement with Novo Nordisk for DuoBody technology

Improved operating result by DKK 151 million over the first nine months of 2014

2015 financial guidance improved

"The third quarter was certainly a busy one in terms of regulatory filings for our antibody programs. We were very pleased that the FDA granted Priority Review and the EMA granted accelerated assessment to the regulatory applications for daratumumab in heavily pretreated or double refractory multiple myeloma patients. Regulatory submissions for ofatumumab as maintenance treatment for relapsed CLL were also submitted in the US and Europe and the US application received Priority Review. We also announced a new commercial agreement for the DuoBody technology with Novo Nordisk this quarter. With the end of the year coming up fast, we will continue to work towards our annual goals, while maintaining our focus on our vision of transforming cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months
Revenue was DKK 558 million in the first nine months of 2015 compared to DKK 635 million in the first nine months of 2014. The decrease of DKK 77 million or 12% was mainly driven by lower milestone and cost reimbursement revenue under our daratumumab collaboration with Janssen.

Operating expenses were DKK 380 million in the first nine months of 2015 compared to DKK 431 million in the first nine months of 2014. The decrease of DKK 51 million or 12% was primarily related to a decrease in costs associated with the ofatumumab and daratumumab programs, which was partly offset by increased investment in our research and development pipeline.
Operating income was DKK 355 million in the first nine months of 2015 compared to DKK 204 million in the first nine months of 2014. The improvement of DKK 151 million was driven by the positive effect from the reversal of the ofatumumab funding liability of DKK 176 million combined with lower expenses, which were partly offset by decreased revenue.

On September 30, 2015, Genmab had a cash position of DKK 3,206 million. This represented a net increase of DKK 545 million from December 31, 2014, which was driven primarily by the proceeds from exercise of warrants of DKK 598 million partly offset by the increased investment in our research and development activities to advance our pipeline of products.

Business Progress Third Quarter to Present

Daratumumab
September: The CHMP of the EMA granted accelerated assessment to the Marketing Authorization Application (MAA) for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma.

September: The MAA for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma was submitted to the EMA by Janssen-Cilag International NV. The submission triggered a USD 10 million milestone payment to Genmab from Janssen.

September: The U.S. FDA granted Priority Review to the Biologics License Application (BLA) for daratumumab as a treatment for patients with double refractory multiple myeloma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.

July: The rolling submission of a BLA to the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15 million milestone payment to Genmab.

Other
September: The U.S. FDA granted Priority Review to the sBLA for ofatumumab as maintenance therapy for patients with relapsed CLL. The FDA assigned a PDUFA target date of January 21, 2016.

August: Entered an agreement granting Novo Nordisk commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs.

July: Announced that Novartis submitted regulatory applications to the EMA and FDA for the use of ofatumumab as maintenance therapy for patients with relapsed CLL.

Q4 Events
October: Achieved five pre-clinical milestones under our DuoBody technology collaboration with Janssen, triggering total payments of USD 8.5 million to Genmab.

Outlook
Genmab is improving its 2015 financial guidance published on August 19, 2015, due to increased revenue and lower operating expenses resulting in increased operating income and cash position.

On November 03, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer, reported consolidated financial results for the third quarter of 2015 and progress in its proprietary and partnered clinical development programs (Press release, NewLink Genetics, NOV 3, 2015, View Source [SID:1234507912]).

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"Our dynamic and experienced team has made significant progress in driving our broad clinical development programs," said Charles Link, M.D., Chairman and Chief Executive Officer. "We look forward to reporting on our strong pipeline of clinical data over the coming year."

Dr. Link added, "GDC-0919, the checkpoint inhibitor program partnered with Genentech continues to make great progress. Both companies are putting substantial resources behind this program, and we continue to be excited about the development plan and the progress of our collaboration."

"As we anticipate the data readout for the IMPRESS trial in 2016, NewLink Genetics continues to advance its investment in manufacturing and pre-commercial activities relating to algenpantucel-L, our HyperAcute Cellular Immunotherapy product candidate for patients with resected pancreatic cancer," said Nicholas Vahanian, M.D., President and Chief Medical Officer. "We await the promise of our cellular immunotherapy agents to educate the immune system to destroy tumor cells in pancreatic and other cancers."

Financial Results for the Three-Month Period Ended September 30, 2015

Cash Position: NewLink Genetics ended the quarter on September 30, 2015, with cash, cash equivalents, and certificates of deposit totaling $200.4 million, compared to $202.8 million for the year ending December 31, 2014 .

R&D Expenses: Research and development expenses in the third quarter of 2015 were $22.5 million, compared to $10.9 million during the comparable period in 2014. The increase is primarily due to clinical trial expenses related to NewLink Genetics’ broad pipeline of product candidates, as well as expenses for manufacturing and research related to the Ebola vaccine candidate. The majority of the Ebola-related expenses are subject to reimbursement under government contracts.

G&A Expenses: General and administrative expenses in the third quarter of 2015 were $7.4 million, compared to $4.9 million during the comparable period in 2014. The increase was primarily due to an increase in share-based compensation expense, consulting and legal fees, and medical affairs and pre-commercial activities.

Net Loss: NewLink Genetics reported a net loss of $15.9 million, or ($0.55) per diluted share, for the third quarter of 2015, compared to a net loss of $5.6 million, or ($0.20) per diluted share, for the comparable period in 2014.

NewLink Genetics ended the quarter with 28,774,911 shares outstanding.

Financial Guidance

NewLink Genetics expects to have more than $160 million in cash and equivalents on December 31, 2015.

Conference Call and Program Updates:

The Company has scheduled a conference call for 8:30 a.m. ET today to discuss these results and to provide an update on clinical and business development activities. Dial-in information for the conference call is set forth at the end of this press release. Programs to be discussed include:

IDO Checkpoint Inhibitor Programs

NewLink Genetics entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO checkpoint inhibitor GDC-0919 and an expanded pipeline of potential IDO/TDO inhibitor candidates in 2014. This product candidate is currently in Phase 1 clinical development for patients with advanced solid tumors.

Key preclinical data is being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Bethesda, Maryland on November 6, 2015.

Phase 1 data on GDC-0919 was presented at the ECC/ESMO meeting in Vienna. Key preliminary data showed that GDC-0919 had a favorable safety profile and preliminary evidence of disease stabilization and peripheral pharmacodynamic modulation. Details from the poster presentation are available in the press release found at View Source
The collaboration’s clinical development team has advanced GDC-0919 into a combination study with atezolizumab that is actively enrolling patients. In addition, the collaboration is planning combination studies of GDC-0919 with OX-40 agonists.
NewLink will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.
Indoximod, NewLink Genetics’ proprietary IDO pathway inhibitor, is in multiple Phase 1 and Phase 2 clinical trials for patients with breast, prostate, pancreatic and brain cancers as well as melanoma. We will provide additional details about our trials on the conference call. Additionally, there will be multiple opportunities for the Company to provide further updates during 2015 and 2016 at academic meetings and associated programs.

HyperAcute Cellular Immunotherapy Programs

NewLink Genetics’ proprietary HyperAcute Cellular Immunotherapy programs may prove to have broad potential for patients across a spectrum of cancer indications, including use in combination with checkpoint inhibitors.

Algenpantucel-L is NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with pancreatic cancer. The product is currently being studied in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESectable Cancer Study, in patients with surgically resected pancreatic cancer. The study is powered to show an improvement in overall survival after 442 events, and we continue to expect that final results will be reported in 2016.

PILLAR, or Pancreatic Immunotherapy with Algenpantucel-L for Locally Advanced Non-Resectable Disease, is our Phase 3 clinical trial studying the efficacy of algenpantucel-L for patients with borderline resectable or locally advanced unresectable pancreatic cancer. We expect to complete enrollment in this study in 2015.

Tergenpumatucel-L

Tergenpumatucel-L, NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with non-small cell lung cancer (NSCLC), remains in Phase 2. We are eager to learn more about this product in our recently begun trial evaluating tergenpumatucel-L in combination with indoximod and chemotherapy for patients with advanced NSCLC.

Dorgenmeltucel-L

Dorgenmeltucel-L, NewLink Genetics’ HyperAcute Cellular Immunotherapy product candidate for patients with melanoma, continues in a trial evaluating efficacy in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab for patients with advanced melanoma.

Ebola Vaccine

During the third quarter, we announced that NewLink Genetics was awarded an $8.1 million base contract with future options totaling $5.2 million by the Defense Threat Reduction Agency of the United States Department of Defense to support various development activities of the investigational rVSV-ZEBOV (Ebola) vaccine candidate. Additionally, the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services exercised an $18 million option on NewLink Genetics’ existing contract.

NewLink has exclusively licensed research, development, manufacturing and commercialization of the rVSV-ZEBOV (Ebola) vaccine to Merck. This vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC).

On November 3, 2015 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the third quarter and year-to-date periods ended September 30, 2015 (Filing, 8-K, AMAG Pharmaceuticals, NOV 3, 2015, View Source [SID:1234507909]). Total revenues for the third quarter of 2015 increased to $96.2 million, compared with $25.5 million in the third quarter of 2014. This increase is primarily related to the additions of Makena (hydroxyprogesterone caproate injection) in November 2014 and Cord Blood Registry (CBR) in August 2015 to the company’s portfolio, which contributed revenue of $65.2 million and $7.2 million, respectively, to the third quarter 2015 results. After certain non-cash and one-time costs related to business development activities and acquisitions, the company reported an operating loss of $1.4 million in the third quarter of 2015, compared with operating income of $4.3 million in the same period last year. This resulted in a net loss of $20.6 million, or $0.62 per basic and diluted share, compared with net income of $1.5 million, or $0.07 per basic share and $0.06 per diluted share for the same period last year.

Non-GAAP revenue totaled $103.5 million in the third quarter of 2015, compared with $23.5 million for the same period last year.(1) The company reported adjusted EBITDA of $52.8 million in the third quarter of 2015, compared with adjusted EBITDA of $1.3 million in the third quarter of 2014.(1) Non-GAAP cash earnings for the third quarter of 2015 totaled $42.3 million, or $1.02 per diluted share, compared with $0.3 million, or $0.01 per diluted share, for the same period in 2014.(1),(2)

"While our overall portfolio experienced growth during the third quarter, we believe there is opportunity for even better performance in the future as integration activities are completed and our investments in the next generation development programs for Makena and an expanded label for Feraheme progress toward FDA approvals and launches," said William Heiden, AMAG’s chief executive officer. "With our business continuing to generate strong cash flows, we will maintain our focus on executing on the opportunities we have today, line extension approvals in the future, as well as continued portfolio expansion through acquisitions and licensing transactions."

3Q15 Business Highlights and Recent Developments

· Makena net sales totaled $65.2 million in the third quarter of 2015, representing 36% growth over the corresponding period in the prior year.(3) The growth in sales was driven by a 42% increase in volume partially offset by a decrease in net revenue per injection due to higher growth in the Medicaid versus commercial segment.

· Sales of Feraheme (ferumoxytol) injection returned to growth, increasing 3% to $23.2 million in the third quarter of 2015, compared with $22.5 million in the same period last year. Sales of MuGard grew 16% in the third quarter of 2015 over the same period last year.

· The company closed on the acquisition and financing of CBR, the world’s largest stem cell collection and storage company, on August 17, 2015. The CBR business recorded $14.5 million of non-GAAP revenue for the six-week period between closing and September 30, 2015.(1) On a pro forma basis (as if AMAG had acquired CBR at the beginning of the third quarter of 2015), total CBR revenue was $29.3 million, compared with $33.0 million in the third quarter of 2014, with the decrease being partially attributable to new customer discounts in the third quarter of 2015.(4)

· During the third quarter of 2015, the company announced plans to further expand its growing maternal health portfolio by entering into an exclusive option agreement with Velo Bio, LLC, a privately held life sciences company. The agreement gives the company the option to acquire the global rights to an orphan drug candidate in clinical development for use in the treatment of severe preeclampsia, an area of high unmet need in pregnant women.

· The Company recently announced start-up activities for a head-to-head, Phase 3 clinical trial evaluating Feraheme in adult patients with iron deficiency anemia (IDA). The study marks a step forward on the pathway to potentially 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. The company expects to begin enrolling patients in the trial in the first quarter of 2016, with potential approval of a supplemental new drug application for a broader IDA indication and launch in 2018.

· The company advanced its next generation development programs for Makena seeking to enhance the product for patients and their healthcare providers. As previously disclosed, the company has filed for approval of a single-dose, preservative-free version of Makena, with anticipated approval in the fourth quarter of 2015. In addition, the company is developing a device for subcutaneous administration of Makena by an auto-injector. The company has an exclusive agreement in place with a device partner whose technologies are covered by multiple issued patents, and has other approved products in its portfolio. AMAG is also developing a longer-acting formulation of Makena.

Third Quarter Ended September 30, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues for the third quarter of 2015 were $96.2 million, compared with $25.5 million for the same period in 2014. Net product sales of Makena, Feraheme and MuGard totaled $88.9 million in the third quarter of

(3) Based on unaudited pro forma sales for the third quarter of 2014. Acquisition of Lumara Health closed in November 2014.
(4) Based on unaudited pro forma sales for the third quarter of 2015 and 2014. Acquisition of CBR closed on August 17, 2015.

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2015, compared with $23.0 million in the third quarter of 2014. Service revenue from CBR totaled $7.2 million in the third quarter of 2015.

Total costs and expenses for the third quarter of 2015 were $97.5 million, compared with $21.2 million for the same period in 2014. The increases in costs and expenses were primarily due to the following: (i) 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, (ii) increased cost of goods sold from new product and higher sales volumes for each of the company’s products, (iii) non-cash charges associated with inventory step-up and amortization related to the acquisitions, (iv) a $10.0 million upfront payment for the exclusive option to acquire rights to a development stage asset to treat severe preeclampsia, and (v) $9.2 million in acquisition and restructuring costs related to CBR.

The company reported an operating loss of $1.4 million and a net loss of $20.6 million, or $0.62 per basic and diluted share, for the third quarter of 2015, compared with operating income of $4.3 million and net income of $1.5 million, or $0.07 per basic share and $0.06 per diluted share, for the same period in 2014.

Financial Results (Non-GAAP Basis)(1),(2)

Non-GAAP revenues totaled $103.5 million, up from $23.5 million in the third quarter of 2014. Non-GAAP CBR revenue totaled $14.5 million in the third 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 $50.6 million resulting in a gross margin of 93% and adjusted EBITDA margin of 51% for the third quarter of 2015. This compares to costs and expenses of $22.3 million in the same period of 2014, which resulted in a gross margin of 90% and adjusted EBITDA margin of 5%. Non-GAAP adjusted EBITDA for the third quarter of 2015 was $52.8 million, compared with $1.3 million for the same period in 2014.

After deducting cash interest expense, the company generated third quarter non-GAAP cash earnings of $42.3 million, or $1.27 per non-GAAP basic share and $1.02 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share for the third quarter of 2015 includes the impact of the convertible debt and related bond hedge and warrants.

Balance Sheet Highlights

As of September 30, 2015, the company’s cash and investments totaled approximately $442.9 million and total debt (face value) was $1.05 billion.

"The two transformative acquisitions that we completed in the past twelve months have allowed us to significantly grow our top line while delivering strong cash flows and profitability for our shareholders," said Frank Thomas, AMAG’s president and chief operating officer. "As we continue to integrate the businesses, we are anticipating even better financial and operating performance, allowing us to serve our patients more effectively and efficiently."

Nine Months Ended September 30, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues for the nine months ended September 30, 2015 were $309.5 million, compared with $71.1 million for the same period in 2014. This increase is primarily related to the addition of Makena in November 2014 and CBR in August 2015, which contributed $184.3 million and $7.2 million, respectively, in product revenue to the year-to-date 2015 results. In addition, the company recognized $39.2 million of collaboration revenue in 2015 related to the termination of the company’s ex-US ferumoxytol marketing agreement with Takeda Pharmaceutical Company Limited.

Net income for the first nine months of 2015 totaled $25.6 million, compared with a net loss of $7.2 million for same period in 2014. Basic net income per share was $0.84, compared with a net loss per basic share of $0.33 in 2014. Diluted net income per share was $0.73 in 2015, compared with a net loss per diluted share of $0.33 in 2014. The weighted average diluted shares used in calculating diluted net income per share for the first nine months of 2015 followed the if-converted method of accounting for the convertible debt.

Financial Results (Non-GAAP Basis)(1),(2)

Non-GAAP adjusted EBITDA for the nine months ended September 30, 2015 was $152.1 million, compared with a loss before interest, taxes, depreciation and amortization of $0.8 million for the same period in 2014. After deducting cash interest expense, the company generated non-GAAP cash earnings of $127.2 million, or $3.31 per non-GAAP diluted share.

Updating 2015 Financial Outlook(6)

The company is updating its full year 2015 guidance to include revenue from CBR and reflect the business performance for the first nine months and the outlook for the remainder of 2015.