1stOncology™: Cancer Intelligence Service – Page 14324 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BioLineRx to Report Annual 2017 Results on March 6, 2018

On February 27, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it will release its audited annual financial results for the year ended December 31, 2017 on Tuesday, March 6, 2018, before the US markets open (Press release, BioLineRx, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2334829 [SID1234524194]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The Company will host a conference call on Tuesday, March 6, 2018 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-668-9141 from the U.S. or +972-3-918-0609 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 9, 2018; please dial +1-888-326-9310 from the U.S. or +972-3-925-5901 internationally.

BioCryst Reports Fourth Quarter and Full Year 2017 Financial Results

On February 27, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, BioCryst Pharmaceuticalsa, FEB 27, 2018, View Source [SID1234524193]).

"Our team made significant progress in 2017 and we are off to a strong start in 2018," said Jon P. Stonehouse, President & Chief Executive Officer. "We are keenly focused on continuing that momentum by advancing our pipeline, adding additional programs and driving our BCX7353 oral prophylactic program toward approval and launch. We are on track to report top-line results from the APeX-2 pivotal trial of BCX7353 and to initiate a Phase 1 clinical trial for our recently unveiled ALK2 inhibitor program for treating FOP in the first half of 2019."

Mr. Stonehouse continued, "In January, we announced our proposed merger with Idera Pharmaceuticals, Inc. that we believe will build greater and more sustainable value for the benefit of stockholders as well as patients with rare diseases beyond what we could achieve alone. The BioCryst Board determined this combination was compelling from both a strategic and financial perspective following a careful evaluation of a range of strategies to enhance long-term stockholder value. The transaction will create a leading rare disease company with a robust pipeline including two promising Phase 3 programs and combines synergistic discovery engines that will not only expand the number of rare diseases we can target but create meaningful opportunities for differentiation in the market through joint small molecule and oligo treatments. Importantly, joining with Idera will also enable us to achieve cost synergies and increase our financial strength and flexibility."

Fourth Quarter Financial Results

For the three months ended December 31, 2017, total revenues were $3.9 million, compared to $9.0 million in the fourth quarter of 2016. The decrease in revenue was primarily due to the recognition of $2.3 million of RAPIVAB product sales to commercial partners in 2016 that did not recur in 2017 and approximately a $2.5 million decline in collaborative revenue in 2017, associated with a decrease in development activity under U.S. Government development contracts.

Research and Development (R&D) expenses for the fourth quarter of 2017 increased to $16.9 million from $12.2 million in the fourth quarter of 2016, primarily due to additions in R&D personnel, as well as increased spending to advance the Company’s hereditary angioedema (HAE) portfolio. These increases were partially offset by a decrease in the Company’s galidesivir development expenses in 2017.

General and administrative (G&A) expenses for the fourth quarter of 2017 increased to $4.7 million, compared to $2.6 million in the fourth quarter of 2016. The increase was primarily due to approximately $1.5 million of merger-related costs associated with the Company’s previously announced definitive merger agreement with Idera Pharmaceuticals, Inc. (Idera).

Interest expense was $2.2 million in the fourth quarter of 2017, compared to $2.1 million in the fourth quarter of 2016. Also, a $71,000 mark-to-market gain on the Company’s foreign currency hedge was recognized in the fourth quarter of 2017, as compared to a $5.7 million mark-to-market gain in the fourth quarter of 2016. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate.

Net loss for the fourth quarter of 2017 was $19.5 million, or $0.20 per share, compared to a net loss of $4.5 million, or $0.06 per share, for the fourth quarter 2016.

Full Year 2017 Financial Results

For the year ended December 31, 2017, total revenues decreased to $25.2 million from $26.4 million in 2016. The decrease in 2017 revenue was primarily due to lower collaborative revenue under U.S. Government development contracts as well as lower revenue from product sales to corporate partners. These decreases were largely offset by $7.0 million in milestone payments associated with U.S. pediatric and Canadian regulatory approvals of RAPIVAB.

R&D expenses for 2017 increased to $67.0 million from $61.0 million in 2016, primarily due to increased spending on the Company’s HAE program, partially associated with the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial, as well as an increase in R&D personnel. These increases were partially offset by a decrease in galidesivir development expenses under U.S. Government development contracts.

G&A expenses for 2017 increased to $13.9 million, compared to $11.3 million in 2016. The increase was due primarily to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial as well as merger-related costs associated with the Company’s definitive merger agreement with Idera.

Interest expense was $8.6 million in 2017, compared to $6.5 million in 2016. The increase in interest expense was due primarily to the closing of the Company’s $23 million senior credit facility in September 2016. A $1.8 million mark-to-market loss on the Company’s foreign currency hedge was recognized in 2017, as compared to a $1.7 million mark-to-market loss in 2016. These losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate. During 2017 and 2016, the Company also realized currency gains of $966,000 and $811,000, respectively, from the exercise of a U.S. Dollar/Japanese yen currency option within its foreign currency hedge.

Net loss for 2017 was $65.8 million, or $0.78 per share, compared to a net loss of $55.1 million, or $0.75 per share for the same period last year.

Cash, cash equivalents and investments totaled $159.0 million at December 31, 2017, and reflect an increase from $65.1 million at December 31, 2016. Net operating cash use for 2017 was $41.8 million, which excludes $134.0 million of net proceeds from the March and September 2017 public offerings.

Clinical Development Update & Outlook

Enrollment in the 750 mg cohort of the Zenith-1 proof-of-concept Phase 2 clinical trial of a liquid formulation of BCX7353 for treatment of acute angioedema attacks in HAE has been completed and the 500 mg cohort is currently enrolling. We expect to report top-line results from the first cohort in the second half of 2018.

On January 5, 2018, BioCryst announced that it had advanced a discovery program exploring activin receptor-like kinase-2 (ALK2) inhibitors for treatment of Fibrodysplasia Ossificans Progressiva (FOP) into Investigational New Drug Application (IND) enabling nonclinical development. The Company’s optimized lead candidates, BCX9250 and BCX9499, are projected to enter Phase 1 clinical trials during the first half of 2019.

On January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. The combined company will be renamed upon closing, and will be led by Vincent Milano, CEO of Idera. Jon Stonehouse will serve as a member of the Board of Directors. The transaction is subject to approval by the stockholders of both companies, as well as the satisfaction of customary closing conditions. The transaction is expected to be completed by the end of the second quarter of 2018.
Financial Outlook for 2018

Based upon development plans and the Company’s awarded government contracts, on a stand-alone basis, BioCryst expects its 2018 net operating cash use to be in the range of $67 to $90 million, and its 2018 operating expenses to be in the range of $85 to $110 million. The Company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.

Company and Idera File Joint Preliminary Proxy Statement / Prospectus and Updated Merger Presentation

The Company also today provided an updated investor presentation regarding the proposed merger with Idera Pharmaceuticals, which was announced on January 22, 2018. The presentation and a joint preliminary proxy statement / prospectus were filed today with the U.S. Securities and Exchange Commission (the "SEC"), and both can be accessed by visiting the "Investors" section of the Company’s website at www.BioCryst.com.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast Tuesday, February 27, 2018 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed live or in archived form in the "Investors" section of the Company’s website at www.BioCryst.com. An accompanying slide presentation may also be accessed via the BioCryst website. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 has been generally safe and well tolerated in the Phase 2 APeX-1 clinical trial. BioCryst is also conducting the ongoing ZENITH-1 clinical trial. ZENITH-1 is a proof-of-concept Phase 2 clinical trial testing an oral liquid formulation of BCX7353 for the treatment of acute angioedema attacks.

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2017 Financial Results and Recent Operational Progress

On February 27, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today reported financial results for the fourth quarter and full year ended December 31, 2017 and recent operational highlights (Press release, Atara Biotherapeutics, FEB 27, 2018, View Source [SID1234524191]).

"Atara continues to advance its leadership in T-cell immunotherapy innovation, highlighted by our recent initiation of the first Phase 3 clinical studies of an off-the-shelf, allogeneic T-cell technology, tab‑cel, in the U.S.," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "We also recently received FDA clearance to expand our pioneering multinational clinical study of off-the-shelf ATA188 for patients with multiple sclerosis in the U.S. We are proud of these accomplishments and believe the next 18 months will be a transformational period for Atara. Our focus is to expand and advance our robust T‑cell immunotherapy pipeline, manufacturing expertise and global commercial capabilities in anticipation of the announcement of the first tab-cel Phase 3 results and submission of an EU conditional marketing authorization application for tab-cel, both expected in the first half of 2019. We also have a well-defined strategy to leverage the potential of our platform in other cancer, autoimmune and viral diseases, as well as initiate development of genetically modified off-the-shelf T-cell immunotherapies to transform the lives of patients with serious medical conditions."

Recent Highlights and Anticipated Upcoming Milestones

Initiated two Phase 3 clinical studies (MATCH and ALLELE) to evaluate tab-cel in patients with EBV+ PTLD who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
° Six clinical sites for the MATCH and eight for the ALLELE pivotal studies are now open for enrollment in the U.S. and the studies continue to expand to additional U.S. sites as well as sites in other countries including EU, Canada and Australia.
° Results from the first tab-cel Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019. Atara also plans to submit a Conditional Marketing Authorization (CMA) application for tab-cel in the EU for patients with EBV+ PTLD who have failed rituximab following HCT during the first half of 2019.

Received clearance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to proceed with patient enrollment at U.S. sites for the Company’s ongoing multinational Phase 1 clinical study to evaluate ATA188 in patients with progressive or relapsing-remitting multiple sclerosis (MS).
° The primary objective of the Phase 1 study is to assess the safety of ATA188 in patients followed for at least one year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale (EDSS) and annualized relapse rate (ARR), as well as MRI imaging.
° We believe that ATA188 may allow for a more consistent reactivity against target EBV antigens, which correlated with clinical improvements in a previous autologous ATA190 Phase 1 study in patients with progressive MS.
° The first results from the ATA188 Phase 1 study in patients with progressive MS are expected in the first half of 2019.
Presented positive interim tab-cel results from a multicenter expanded access protocol (EAP) study for patients with EBV associated cancers at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
° In 6 patients with EBV+ PTLD who have failed rituximab following SOT, the Objective Response Rate (ORR) was 83%, with 5 of 6 patients responding to treatment.
° Additionally, in 5 patients with EBV+ PTLD who have failed rituximab following allogeneic HCT, an ORR of 80% was observed, with 4 of 5 patients responding to treatment.
° Safety findings were reported for a total of 23 patients and demonstrated that tab-cel was generally well-tolerated in this study population, which comprised ill, mostly immunosuppressed patients with multiple comorbidities. Five patients experienced treatment-related serious adverse events (SAEs).
Continue to build core commercial and clinical development capabilities in preparation for the expected submission of the tab-cel CMA in the EU and potential launch.
° Appointed Dr. Derrell Porter as Senior Vice President, Global Commercial Head, who brings extensive oncology and specialty commercialization experience to the management team.
° Appointed Dr. Kanya Rajangam as Senior Vice President and Chief Medical Officer, who has leadership experience advancing multiple global, early- and late-stage oncology programs.
° Identified Atara’s EU headquarters in Zug, Switzerland and began recruiting key global functional leadership and staff.
° Plan to announce partner for Atara MatchMeTM, our off-the-shelf T-cell immunotherapy delivery solution, in the first half of 2018.

Plan to initiate a Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) in the second half of 2018.

Expect to present updated tab-cel results in patients with EBV+ cancers in the second half of 2018.

Plan to communicate development strategy for CMV and other viral disease programs in the second half of 2018.

Expect operations to commence at Atara T Cell Operations & Manufacturing (ATOM) facility in 2018, with clinical production anticipated in 2019.
Fourth Quarter and Full Year 2017 Financial Results

Cash, cash equivalents and short-term investments as of December 31, 2017 totaled $166.1 million, which the Company believes, along with the $131.4 million net proceeds from the sale of 7,675,072 shares of common stock in an underwritten public offering completed in January 2018, will be sufficient to fund planned operations into the first half of 2020.
The Company reported net losses of $35.3 million, or $1.15 per share and $119.5 million, or $4.00 per share, for the fourth quarter and fiscal year 2017, as compared to $18.2 million, or $0.63 per share and $79.0 million, or $2.75 per share, for the same periods in 2016.
Research and development expenses were $24.8 million and $81.2 million for the fourth quarter and fiscal year 2017, as compared to $13.5 million and $56.5 million for the same periods in 2016. The increases in the fourth quarter and fiscal year 2017 were due to costs associated with the Company’s continuing expansion of research and development activities, including:
° manufacturing and outside service costs related to the preparation for the two tab-cel Phase 3 clinical studies in patients with EBV+ PTLD who have failed rituximab;
° ongoing costs for the Company’s EAP clinical study for tab-cel, which was initiated in mid-2016;
° clinical manufacturing and preparations for the Phase 1 clinical study of allogeneic ATA188, which was initiated in October 2017;
° higher payroll and related costs from increased headcount, and
° an increase in allocated facilities and information technology expenses.
Research and development expenses include $2.5 million and $8.8 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2017, as compared to $0.4 million and $7.6 million for the same periods in 2016.
General and administrative expenses were $11.0 million and $40.3 million for fourth quarter and fiscal year 2017, as compared to $5.3 million and $24.7 million for the same periods in 2016. The increases in the fourth quarter and fiscal year 2017 were primarily due to increases in payroll and related costs driven by increased headcount to support the Company’s expanding operations and higher professional services costs. General and administrative expenses include $3.6 million and $14.3 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2017, as compared to $1.3 million and $9.2 million for the same periods in 2016.
About EBV+ PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing allogeneic hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV associated post-transplant lymphoproliferative disorder (EBV+ PTLD), represents a life-threatening condition. Median overall survival in patients with EBV+ PTLD following HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV+ PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One- and two-year survival in patients with high-risk EBV+ PTLD following SOT is 36% and 0%, respectively.

About tab-cel (tabelecleucel; formerly known as ATA129)
Atara’s most advanced T-cell immunotherapy in development, tab-cel, is a potential treatment for patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). In February 2015, FDA granted tab-cel Breakthrough Therapy Designation for EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) and in October 2016, tab-cel was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. Atara also received positive regulatory feedback from Health Canada in September 2017 supporting the submission of tab-cel for an expedited approval pathway. In addition, tab-cel has orphan status in the U.S. and EU. Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and a Phase 1/2 study in NPC is planned for 2018. Tab-cel is also available to eligible patients with EBV associated hematologic and solid tumors through an ongoing multicenter expanded access protocol clinical study, positive interim results of which were presented in December 2017 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

About Multiple Sclerosis (MS)
MS is a chronic neurological autoimmune disease that affects an estimated 2.3 million people around the world. Relapsing-remitting MS (RRMS) is the most common form of MS and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Despite available disease-modifying treatments, most individuals with RRMS continue to experience disease activity and disability progression.

Progressive MS (PMS) is a severe form of the disease with few therapeutic options. PMS comprises two conditions, both characterized by persistent progression and worsening of MS symptoms and physical disability over time. Primary Progressive MS (PPMS) occurs when continuous progressive disease is present at diagnosis and occurs in approximately 15% of newly diagnosed cases. Secondary Progressive MS (SPMS) initially begins as RRMS and develops into a progressive form. Up to 80% of people with RRMS will eventually develop SPMS. There is substantial unmet medical need for new and effective therapies for patients with PPMS and SPMS. Most treatment options that work well in reducing flares in RRMS have not been shown to be effective in slowing or reversing disability in PMS.

About allogeneic ATA188 and autologous ATA190
Epstein-Barr Virus (EBV) is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis (MS). T-cells are a critical component of the body’s immune system and can selectively target specific EBV antigens believed to be important for the potential treatment of MS. Off-the-shelf ATA188 and autologous ATA190, using the Company’s complementary T-cell immunotherapy technology developed by Professor Rajiv Khanna at QIMR Berghofer, have the potential to precisely recognize and eliminate EBV-infected B-cells and plasma cells in the central nervous system that may catalyze autoimmune responses and MS pathophysiology. Professor Michael Pender from The University of Queensland presented updated results from the first autologous ATA190 study, which was partially funded by MS Research Australia, MS Queensland and Perpetual Foundation, at MSParis 2017 Congress, the 7th Joint ECTRIMS and ACTRIMS Meeting in October 2017. This study tested adoptive immunotherapy in patients with MS and showed that autologous ATA190 led to encouraging clinical improvements in MS symptoms that correlated with autologous ATA190’s reactivity against target EBV antigens (EBV reactivity). In addition to the ongoing Phase 1 autologous ATA190 clinical study in patients with progressive MS, Atara also initiated a multinational Phase 1 ATA188 clinical study in patients with progressive or relapsing-remitting MS in Australia in the fourth quarter of 2017 with patient enrollment at U.S. sites beginning in early 2018.

About CMV
In patients with weakened immune systems, including bone marrow and solid organ transplant recipients, newborns with immature immune systems and those with human immunodeficiency virus (HIV), cytomegalovirus (CMV) can cause potentially life-threatening disease or may result in blindness, brain damage, and deafness. While small molecule antiviral drugs are approved to treat and prevent CMV infection, there remains a high unmet need due to viral resistance, modest neurodevelopmental activity and adverse effects, such as toxicity and reduction in white blood cell count impairing the ability to fight other infections, with these agents.

About ATA230
ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by cytomegalovirus (CMV), has been investigated in one Phase 1 and two Phase 2 clinical studies in immunocompromised patients with CMV viremia or disease who are refractory or resistant to antiviral drug treatment in the post-transplant setting. In October 2017, Atara announced that ATA230 was granted Rare Pediatric Disease Designation by the FDA for the treatment of congenital CMV infection, and in September 2017, ATA230 received orphan drug designation in the U.S. for the treatment of CMV viremia and disease in immunocompromised patients. The European Medicines Agency (EMA) in October 2016 also issued a positive orphan drug designation opinion for ATA230 for the treatment of CMV infection in patients with impaired cell-mediated immunity. Given the opportunity to pursue a CMA in the EU for tab-cel, we have decided to prioritize our EBV related programs ahead of ATA230 at this time, and plan to further evaluate our development strategy for ATA230 in 2018.

AMAG Reports 2017 Financial Results and Company Update

On February 27, 2018 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2017 (Press release, AMAG Pharmaceuticals, FEB 27, 2018, View Source [SID1234524190]).

Total GAAP revenue for the full year of 2017 increased approximately 15% to $609.9 million, driven by increased sales growth across AMAG’s portfolio, which includes Makena (hydroxyprogesterone caproate injection), Feraheme (ferumoxytol injection) and Cord Blood Registry (CBR), as well as the addition of Intrarosa (prasterone) to the company’s portfolio and subsequent launch in July 2017. The company reported a GAAP operating loss of $293.3 million in 2017, due primarily to a third quarter non-cash accounting charge, and non-GAAP adjusted EBITDA of $230.1 million in 2017.1

"2017 was an exciting year for AMAG and we have had a strong start to 2018," said William Heiden, president and chief executive officer. "In early 2017, we expanded our women’s health product portfolio with the in-licensing of Intrarosa and bremelanotide. Our commercial team performed across the board by driving revenue to a record level, with growth coming from each of the key products in our portfolio. Today we also announced strong earnings in a year when we made significant investments in our new products, as well as in next generation opportunities for Makena and Feraheme — which resulted in two sNDA approvals by the FDA this month."

"We have been evolving AMAG into a more fully integrated pharmaceutical company with strong development capabilities. These recent wins from our clinical and regulatory teams, and another NDA filing with the FDA anticipated this quarter, are a testament to the progress that we have made. This new corporate competency, combined with our track record for commercial excellence, positions AMAG well for an exciting future as we continue to work toward bringing new therapies to patients in need," continued Mr. Heiden.

2017 Highlights and Recent Events:
Financial
•
Achieved record revenue of $609.9 million, with every key AMAG product growing over 2016
•
Reduced total debt by nearly 20% and extended maturities, ending 2017 with cash and cash investments of $328.7 million
Business Development
•
Expanded product portfolio with Intrarosa and bremelanotide and established new 170-person women’s health commercial team
Intrarosa
•
Launched Intrarosa; drove broad awareness and access; over 5,000 HCPs have prescribed Intrarosa
•
Phase 3 hypoactive sexual desire disorder (HSDD) study in post-menopausal women initiated by AMAG’s partner, Endoceutics

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

Makena
•
Received FDA approval for subcutaneous auto-injector (February 14, 2018)
•
Achieved record sales of $387.2 million, an increase of 16% over 2016
Feraheme
•
Received FDA approval for broad IDA label (February 2, 2018)
•
Grew sales to $105.9 million, an increase of 9% over 2016
CBR
•
Increased storage revenue by approximately $7.4 million, or 9%, over 2016
•
Grew new first-time enrollments by 4% over 2016
Bremelanotide
•
Completed clinical work with partner, Palatin, for planned new drug application (NDA) submission in the first quarter of 2018

Fourth Quarter Financial Results Ended December 31, 2017 (unaudited)
GAAP Fourth Quarter Financial Results
Total GAAP revenues for the fourth quarter of 2017 were $158.3 million, compared with $151.6 million for the same period in 2016. In the fourth quarter of 2017, sales of Makena increased to $100.4 million, compared with $97.2 million in the same period last year; sales of Feraheme and MuGard were $26.6 million; and service revenue from CBR increased to $29.8 million, compared with $27.7 million in the same period last year.

Total costs and expenses, including costs of product sales and services, were $165.5 million in the fourth quarter of 2017, compared with $137.0 million in the same period in 2016. This increase was primarily related to a $33.9 million increase in amortization expense for the Makena intramuscular intangible asset, which contributed to an operating loss of $7.1 million, compared with operating income of $14.6 million in the prior year period. The company reported net income of $3.5 million, or $0.10 per basic and diluted share, in the fourth quarter of 2017, compared with a net loss of $10.6 million, or $(0.31) per basic and diluted share, in the same period of 2016. Net income in the fourth quarter of 2017 was driven primarily by a decrease in the deferred tax liability due to federal tax reform.

Non-GAAP Fourth Quarter Financial Results1
Non-GAAP revenue totaled $159.7 million in the fourth quarter of 2017, up from $153.0 million in same period last year. Non-GAAP CBR service revenue totaled $31.2 million in the fourth quarter of 2017, compared with $29.1 million in the fourth quarter of 2016. The difference between GAAP and non-GAAP revenue represents CBR purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $94.0 million, resulting in an adjusted EBITDA margin of 41% in the fourth quarter of 2017. Non-GAAP adjusted EBITDA totaled $65.7 million in the fourth quarter of 2017, compared to $77.4 million recorded in the fourth quarter of 2016. The decline in adjusted EBITDA for the fourth quarter of 2017 was in line with the company’s expectations and previously stated plans to invest in the commercial launch of Intrarosa while also advancing bremelanotide as the company prepares to file the NDA in the first quarter of 2018.

Full Year Financial Results Ended December 31, 2017 (unaudited)
GAAP Full Year Financial Results
Total GAAP revenues in 2017 increased 15% to $609.9 million, compared with $532.1 million in 2016. This increase was driven by record sales of Makena in 2017 and increased sales of Feraheme and CBR, as well as the commercial launch of Intrarosa in July 2017. In 2017, net sales of Makena increased 16% to $387.2 million, compared with $334.1 million in 2016; sales of Feraheme and MuGard increased 9% to $106.7 million, compared with $98.1 million in 2016; and service revenues from CBR increased 15% to $114.2 million, compared with $99.6 million in 2016.

Total costs and expenses on a GAAP basis, including costs of product sales and services, totaled $903.2 million in 2017, compared with $453.2 million in 2016. The increase in total costs and expenses in 2017 was primarily due to (i) the third quarter non-cash impairment charge related to the Makena intramuscular intangible asset of $319.2 million, (ii) acquired in-process research and development expense in 2017 of $65.8 million primarily due to our license agreement with Palatin Technologies for the rights to bremelanotide, and (iii) higher amortization expense of the Makena intramuscular intangible asset, partially offset by a reduction in our fair value estimate of contingent consideration.

Higher costs and expenses in 2017 (including the third quarter non-cash impairment charge) resulted in an operating loss of $293.3 million, compared to operating income of $78.9 million in 2016. The company reported a net loss of $199.2 million, or $(5.71) per basic and diluted share in 2017, compared with a net loss of $2.5 million, or $(0.07) per basic and diluted share in 2016.

Non-GAAP Full Year Financial Results2
Non-GAAP revenues increased 12% to $615.4 million in 2017, compared with $549.1 million in 2016. Non-GAAP CBR service revenue totaled $119.7 million in 2017, compared with non-GAAP CBR service revenue of $116.6 million in 2016.

Total costs and expenses on a non-GAAP basis totaled $385.3 million, resulting in adjusted EBITDA of $230.1 million in 2017. This compares to costs and expenses of $283.4 million and adjusted EBITDA of $265.7 million in 2016. The increase of approximately $101.9 million in total costs and expenses in 2017, compared with 2016 was consistent with the company’s stated plan to invest in its expanding portfolio of products. The majority of the increase, approximately $81.8 million, was substantially related to the hiring of the Intrarosa commercial team and costs associated with the product launch during the second half of 2017.

Balance Sheet Highlights
The company ended 2017 with $328.7 million in cash and investments and total debt (principal amount outstanding) of $816.4 million. In 2017, the company reduced its overall indebtedness by nearly 20% and extended maturities through a series of financing transactions that were completed in the second quarter.

2018 Financial Guidance2
The company affirms the following financial guidance for 2018.
$ in millions

Total revenue
$500 – $560
GAAP operating loss
($147) – ($117)
Non GAAP adjusted EBITDA
$100 – $130
2 See reconciliation of 2018 GAAP to non-GAAP financial guidance at conclusion of this press release.

"In 2017, we delivered strong top- and bottom-line results while investing aggressively in the products that we expect will drive future growth and shareholder value," said Ted Myles, executive vice president and chief financial officer. "We also improved our liability profile so that our balance sheet is better aligned with our evolving business strategy. We have a solid plan for 2018 focused on executional excellence across our portfolio, and with two FDA approvals this month, we are off to a great start."

Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company’s fourth quarter and full year 2017 financial results and recent developments.

Dial-in Number
U.S./Canada Dial-in Number: (877) 412-6083

International Dial-in Number: (702) 495-1202
Conference ID: 5496159

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 5496159

A telephone replay will be available from approximately 11:00 a.m. ET on February 27, 2018 through midnight on March 5, 2018.

The webcast with slides will be accessible through the Investors section of AMAG’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

Use of Non-GAAP Financial Measures
AMAG has presented certain non-GAAP financial measures, including non-GAAP revenue and non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). 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 at the conclusion of this press release.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Momenta Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Momenta Pharmaceuticals, 2018, FEB 26, 2018, View Source [SID1234524214]).