On May 4, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported operating results for the quarter ended March 31, 2018 (Press release, ImmunoGen, MAY 4, 2018, View Source [SID1234526112]).

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!

"We have achieved a number of important milestones to start the year, led by the advancement of mirvetuximab soravtansine," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "Our FORWARD I registration trial continues as planned following the successful outcome of the pre-specified interim futility analysis and the completion of enrollment in the trial earlier than expected. This accelerated accrual reflects the significant interest expressed by the oncology community in mirvetuximab and the need for new treatments in platinum-resistant ovarian cancer. In addition, as we look to expand the eligible patient population for this program, we were also pleased to report encouraging data for mirvetuximab in combination with Keytruda from our FORWARD II trial at SGO in March and look forward to presenting additional data from FORWARD II during 2018, with a poster presentation at ASCO (Free ASCO Whitepaper) for the mirvetuximab and Avastin expansion cohort. Finally, with our continued evolution towards a commercial-stage company, we have strengthened our management team with the addition of Blaine McKee as Chief Business Officer."

Recent Progress

Mirvetuximab Soravtansine

· In April, ImmunoGen announced the completion of patient enrollment two months ahead of schedule in its Phase 3 FORWARD I trial. FORWARD I is designed to support full approval of mirvetuximab as a single-agent therapy for platinum-resistant ovarian cancer.

· In April, ImmunoGen successfully completed a pre-specified interim analysis for futility after 80 progression-free survival (PFS) events in FORWARD I. The study will continue

as planned based on the recommendation of the Independent Data Monitoring Committee and the Company is on-track to report top-line results in first half of 2019.

·In March, ImmunoGen presented data from the dose-escalation FORWARD II cohort evaluating mirvetuximab in combination with Keytruda (pembrolizumab) at the Society of Gynecologic Oncology (SGO) Annual Meeting, demonstrating encouraging efficacy and favorable tolerability in patients with platinum-resistant ovarian cancer. Notably, in the subset of eight patients with medium or high levels of folate receptor alpha (FRα) expression, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median PFS of 8.6 months (95% CI 1.6, upper bound not yet reached), and duration of response of 36.1 weeks. Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study and expects to present data from this cohort later this year.

Early-Stage Pipeline — Novel IGN Compounds

· IMGN779 is a CD33-targeting ADC in a Phase 1 dose-finding study in relapsed/refractory acute myeloid leukemia (AML). Dose escalation is continuing with both biweekly and weekly dosing schedules. The Food and Drug Administration (FDA) has granted orphan-drug designation to IMGN779 for the treatment of AM

IMGN632 is a CD123-targeting ADC in a Phase 1 dose-finding study for AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Research and Innovation
In April, ImmunoGen presented three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting the Company’s ongoing innovation in ADCs, including advancements to payloads and targets for enhanced anti-tumor activity as well as insights into factors that determine the clinical efficacy of ADCs.

Anticipated Upcoming Events

Report updated data from the FORWARD II mirvetuximab plus Avastin (bevacizumab) combination expansion cohort in approximately 50 patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting;

· Anticipate partner Takeda to begin clinical testing of TAK-164 in 2Q 2018;

· Report initial findings from the FORWARD II mirvetuximab plus pembrolizumab combination expansion cohort in 35 patients in the second half of the year;

· Report additional data from IMGN779 Phase 1 dose finding study in 4Q 2018 and identify the recommended Phase 2 dose before the end of the year;

· Report initial data from IMGN632 Phase 1 dose finding study in 4Q 2018; and

· Advance ADAM9 program into IND-enabling activities before year-end.

Financial Results

Revenues for the quarter ended March 31, 2018 were $19.8 million, compared to $28.5 million for the quarter ended March 31, 2017. License and milestone fees of $11.5 million for the first quarter of 2018 included $10.9 million and $0.5 million of recognized upfront fees previously received from Takeda and Debiopharm, respectively, compared to recognition of $12.7 million

of a non-cash fee related to the Company’s license agreement with CytomX and $6 million in partner milestone payments received in the first quarter of 2017. Revenues in the first quarter of 2018 included $7.2 million in non-cash royalty revenues, compared with $7.6 million for the same quarter in 2017, reflecting a change in accounting standards for recognizing royalty revenue. Revenues for the first quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $0.7 million of clinical materials revenue, compared with $1.5 million and $0.7 million, respectively, for the same quarter in 2017.

Operating expenses, including R&D and G&A expenses, for the first quarter of 2018 were $56.6 million, compared to $41.4 million for the same quarter in 2017. R&D expenses for the first quarter of 2018 increased to $44.8 million, compared to $32.9 million for the first quarter of 2017, primarily due to increased clinical trial and drug supply costs driven largely by the accelerated timing of completing patient enrollment in the FORWARD I Phase 3 clinical trial. General and administrative expenses increased in the first quarter of 2018 to $10.0 million, compared to $8.1 million in the same quarter of 2017, primarily due to increased third-party service fees and stock-based compensation. Operating expenses for the first quarter of 2018 also included a $1.7 million restructuring charge due to the workforce reduction related to the decommissioning of our Norwood facility as previously announced by the Company, compared to a $0.4 million charge in the same quarter of 2017 related to losses recorded on leased office space in Waltham.

ImmunoGen reported a net loss of $38.6 million, or $0.30 per basic and diluted share, for the first quarter of 2018, compared to a net loss of $17.3 million, or $0.20 per basic and diluted share, for the same quarter last year.

ImmunoGen had $218.4 million in cash and cash equivalents as of March 31, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $50.0 million for the first quarter of 2018, compared with $33.0 million for the first quarter of 2017. Capital expenditures were $1.0 million and $0.4 million for the first quarter of 2018 and 2017, respectively.

Financial Guidance

ImmunoGen has updated its operating expenses guidance for 2018. ImmunoGen now expects:

operating expenses between $200 million and $205 million.

Guidance for revenues and cash remains unchanged:

revenues between $60 million and $65 million; and

cash and cash equivalents at December 31, 2018 between $115 million and $120 million.

ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations into the fourth quarter of 2019.

Conference Call Information
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 719-325-4799; the conference ID is 2070974. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 18, 2018.

On May 4, 2018 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported financial results for the first quarter of 2018 and highlighted its recent business and pipeline successes (Press release, Ionis Pharmaceuticals, MAY 4, 2018, View Source [SID1234526135]).

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!

"We have successfully executed our commercialization strategy through the expansion of our strategic relationship with Biogen in neurological diseases and our commercialization of inotersen through our affiliate, Akcea. Our strategy is to create tailored commercial solutions for each of our drugs with the aim to maximize the commercial value of the drug and optimize our financial participation in this value. As our most recent collaboration with Biogen demonstrates, we have substantially increased the value of our antisense technology platform in neurological diseases over the last several years. The economics we achieved with our Bayer and Novartis partnerships show that we have done the same in multiple other therapeutic areas," said Stanley T. Crooke, M.D., Ph.D., chairman of the board and chief executive officer. "Looking ahead, we are focused on launching TEGSEDI this year, assuming approval. As Akcea announced yesterday, the FDA decided they needed additional time to review some of our responses to their standard information requests and, therefore, has extended the review period for TEGSEDI. The new PDUFA date is October 6, 2018. We are working closely with the FDA to advance the review of our filing as quickly as possible. This year we also plan to launch WAYLIVRA, assuming approval. The commercialization of these two Ionis drugs will solidify Ionis as a multi-product, profitable company delivering innovative antisense medicines to patients in need."

First Quarter 2018 Financial Highlights

·
Revenues increased by 25%, driven by SPINRAZA royalties
o
Total revenues were $144 million, compared to $116 million in Q1 2017
o
Commercial revenue from SPINRAZA royalties was $41 million, compared to $5 million in Q1 2017
o
R&D revenue included $60 million in licensing fees for two drugs discovered by Ionis under its collaboration with AstraZeneca
o
Beginning in Q2 2018, Ionis’ R&D revenue will include revenue from the amortization of the $500 million technology access fee and equity premium related to Ionis’ expanded strategic research collaboration with Biogen

1
·
GAAP operating and net loss near breakeven; on track for third consecutive year of pro forma operating profitability
o
GAAP operating loss was $3 million in Q1 2018, compared to GAAP operating income of $19 million for the same period in 2017. Pro forma operating income was $25 million in Q1 2018, compared to $40 million for the same period in 2017
o
Operating expenses increased primarily due to higher SG&A expenses as Ionis prepares to commercialize TEGSEDI and WAYLIVRA this year

·
Cash will increase to more than $2 billion, combining Ionis’ first quarter cash balance of more than $1 billion with $1 billion expected upon closing of Ionis’ expanded collaboration with Biogen
o
During Q1 2018, Ionis received more than $155 million in payments from partners

"In the first quarter, we made further progress toward our goal of being a multiproduct, profitable company. We ended the quarter with operating income of $25 million and net income of $27 million, both on a pro forma basis. Our strong first quarter results were driven by a 25% increase in revenue, primarily from substantial SPINRAZA royalties. Completing our seventh consecutive quarter of pro forma operating income keeps us on track for our third consecutive year of proforma operating income even while we prepare to launch two drugs. This strong performance is a direct result of our technology platform delivering high-value drugs combined with our business strategy, which aims to maximize the commercial potential of each of our drugs and optimize our participation in this value," said Elizabeth L. Hougen, chief financial officer of Ionis. "With the $2 billion in cash we expect to have on the closing of the Biogen transaction, we have the financial strength to invest in opportunities that we believe will increase shareholder value, such as advancing and expanding our portfolio of drugs, retaining our drugs longer, and building a growing pipeline of Ionis-owned drugs that we commercialize ourselves through commercial affiliates."

All pro forma amounts referred to in this press release exclude non-cash compensation expense related to equity awards. Please refer to the reconciliation of pro forma and GAAP measures, which is provided later in this release.

Business Highlights

·
Expanded strategic research collaboration with Biogen for neurological diseases – one of the largest research-stage collaborations ever
o
$1 billion upfront to Ionis, including $625 million to purchase Ionis’ stock at a 25% cash premium of $125 million and a $375 million upfront payment
§
Together, the cash premium and upfront payment represent a $500 million technology access fee
o
Ionis is eligible to receive milestone payments and license fees up to $270 million per drug and royalties up to 20% on net sales
o
Disease areas include dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry

2
·
SPINRAZA for SMA – one of the most successful orphan disease drug launches in history
o
SPINRAZA, commercialized by Biogen, continued to generate growth with global revenues of $364 million in Q1 2018
o
Increase of over 25% from last quarter in number of patients on SPINRAZA, including a 16% increase in number of patients treated in the U.S. and a more than 50% increase outside the US
o
Access expanding outside the U.S. with reimbursement in 24 countries; Biogen expects reimbursement in at least seven more countries by the end of 2018
o
Presented data from the SHINE open-label study at the American Academy of Neurology (AAN) annual meeting demonstrating continued benefit, improved motor function and mobility, and longer event-free survival for the most severely affected patients treated with SPINRAZA
o
Presented data from the NURTURE study at the Muscular Dystrophy Association (MDA) Clinical Conference demonstrating continued benefit in motor function for infants, teens and young adults treated with SPINRAZA

·
TEGSEDI (inotersen) for hereditary transthyretin amyloidosis (hATTR) – potential to transform the lives of people with hATTR; on-track to launch in 2018
o
Invested in global commercialization of TEGSEDI by licensing TEGSEDI to Ionis’ majority-owned affiliate, Akcea
§
Optimized Ionis’ commercial participation with up to $1.5 billion in milestone payments and a 60% profit share
o
Early access program enrolling in the U.S. and Europe
o
Global commercial organization staffed and focused on disease education; robust patient support program in place; supply chain in place and launch supplies ready to be labeled
o
Presented data from the Phase 3 NEURO-TTR study, the open label extension study and an investigator sponsored Phase 2 study at the International Symposium on Amyloidosis annual meeting and the AAN annual meeting

·
WAYLIVRA (volanesorsen) for FCS and FPL – potential first treatment for people with FCS; global on-track to launch in 2018
o
Early access program enrolling in the U.S. and Europe
o
Global commercial organization staffed and focused on disease education; robust patient support program in place; supply chain in place and launch supplies ready to be labeled
o
Positive scientific opinion to initiate Early Access to Medicines Scheme (EAMS) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), for the treatment of people with FCS.

·
Collaboration with AstraZeneca for Cardiovascular, Renal and Metabolic Diseases
o
Earned $60 million for the license of second and third antisense drugs, IONIS-AZ5-2.5Rx and IONIS-AZ6-2.5-LRx, to treat a genetically associated form of kidney disease and nonalcoholic steatohepatitis (NASH), respectively, to AstraZeneca
o
As IONIS-AZ5-2.5Rx and IONIS-AZ6-2.5-LRx advance, Ionis may receive up to $300 million for each drug in additional development and regulatory milestone payments, as well as tiered royalties on sales of each drug

3
Pipeline and Technology Progress

·
Presented positive IONIS-HTTRx (RG6042) Phase 1/2 data in people with Huntington’s disease (HD) at the annual CHDI HD conference. IONIS-HTTRx is the first drug in development to lower the disease-causing protein in people with HD
·
Presented data at the AAN annual meeting that demonstrated broad potential of antisense drugs for neurological diseases with 14 presentations on Ionis’ drugs to treat neurological diseases, including SMA, hATTR amyloidosis, Huntington’s disease, Alzheimer’s disease, and ALS
o
Presented additional data from the Phase 1/2 study of IONIS-HTTRx that demonstrated correlations between reductions in mutant huntingtin (mHTT) and improvements in clinical measures of HD
·
Published review paper titled, "RNA-targeted Therapeutics" in Cell Metabolism, authored by Stanley Crooke, M.D., Ph.D.; highlights antisense and other RNA-targeting therapeutics as important platforms for drug discovery across multiple diseases

"This year, we plan to launch two new promising drugs for rare diseases, TEGSEDI and WAYLIVRA. We look forward to adding commercial revenue from these drugs, assuming approval, to our growing revenue from SPINRAZA," said Brett P. Monia, Ph.D., chief operating officer and senior vice president of antisense drug discovery and translational medicine at Ionis Pharmaceuticals. "Our next set of commercial opportunities are on the horizon. We have multiple drugs that we or our partners plan to advance into pivotal studies in the next year or so, including IONIS-HTTRx for patients with Huntington’s disease, IONIS-STAT3-2.5Rx for patients with head and neck cancer and AKCEA-APO(a)-LRx in patients with high Lp(a) and risk of cardiovascular disease. Following closely behind these are drugs for rare diseases that have the potential to move quickly toward the market, including IONIS-GHR-LRx for patients with acromegaly and IONIS-TMPRSS6-LRx for patients with beta thalassemia."

Expected Events Through 2018

·
Launch of TEGSEDI for people with hATTR, assuming approval
·
Launch of WAYLIVRA for people with FCS, assuming approval
·
Report results from six Phase 2 programs, including data from a study with AKCEA-APO(a)-LRx in people with high Lp(a) and AKCEA-ANGPTL3-LRx for people with rare hyperlipidemias
·
Initiate up to nine new clinical studies, including a clinical study of AKCEA-TTR-LRx for hereditary and wild-type forms of ATTR

The recent Biogen transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 in the United States. Biogen and Ionis expect the deal to close in the second quarter of 2018.

Revenue

At the beginning of 2018, Ionis adopted the new revenue recognition accounting standard on a retrospective basis. Starting with Ionis’ first quarter, all periods presented are shown using the new standard. Ionis has labeled its prior period financial statements "as revised" to indicate the change required under the accounting rules. Whenever Ionis refers to prior period results, they reflect the new accounting rules. This change did not have a significant impact on Ionis’ previously reported revenue.

Ionis’ revenue in the first quarter of 2018 was $144.4 million, compared to $115.8 million for the same period in 2017 and was comprised of the following (amounts in millions):

License fees in the first quarter of 2018 were $62 million primarily from AstraZeneca for the license of IONIS-AZ5-2.5Rx and IONIS-AZ6-2.5-LRx. The first quarter of 2017 included $65 million in a license fee from Bayer for the license of IONIS-FXI-LRx.

Operating Expenses

Operating expenses for the first quarter on a GAAP basis were $147.7 million and on a pro forma basis were $119.3 million compared to GAAP operating expenses of $96.3 million and pro forma operating expenses of $75.4 million for the same period in 2017. Operating expenses increased in Q1 2018, compared to 2017, principally due to higher SG&A expenses as Ionis and its affiliate Akcea prepare to commercialize WAYLIVRA and TEGSEDI. The Company’s SG&A expenses also increased in Q1 2018 compared to Q1 2017 because of fees owed under its in-licensing agreements related to SPINRAZA, which increase as the Company’s SPINRAZA revenue increases. R&D expenses accounted for a smaller portion of the increase in operating expenses. R&D expenses increased primarily from medical affairs expenses and manufacturing costs related to TEGSEDI for the planned launch.

Net Income (Loss)

Ionis reported a net loss of $10.8 million for the first quarter of 2018, compared to net income of $9.0 million for the same period in 2017, all according to GAAP. On a pro forma basis, Ionis reported net income of $17.6 million for the first quarter of 2018, compared to net income of $29.9 million for the same period in 2017. Ionis’ GAAP net loss increased and its pro forma net income decreased in the first quarter of 2018 primarily due to increased operating expenses as Ionis prepares to commercialize TEGSEDI and WAYLIVRA.

5
Net Loss Attributable to Noncontrolling Interest in Akcea Therapeutics, Inc.

Akcea sold shares of its common stock to third parties in its IPO in July 2017. From the closing of the IPO through the end of the first quarter in 2018, Ionis owned 68 percent of Akcea. The shares held by third parties represent an interest in Akcea’s equity that Ionis does not control. However, because Ionis continues to maintain overall control of Akcea through its voting interest, Ionis reflects the assets, liabilities and results of operations of Akcea in Ionis’ consolidated financial statements. Ionis reflects the noncontrolling interest attributable to other holders of Akcea’s common stock in a separate line called "Net loss attributable to noncontrolling interest in Akcea" on Ionis’ statement of operations. Ionis’ net loss attributable to noncontrolling interest in Akcea for the first quarter of 2018 was $9.4 million. Ionis also added a corresponding account in its stockholders’ equity section on its balance sheet called "Noncontrolling interest in Akcea Therapeutics, Inc."

In April 2018, Ionis received 8 million shares of Akcea stock for the license of TEGSEDI and AKCEA-TTR-LRx to Akcea and purchased an additional 10.7 million shares of Akcea stock for $200 million, increasing Ionis’ ownership percentage to approximately 75 percent. Ionis will reflect this increase in its ownership percentage in the second quarter of 2018.

Net Income (Loss) Attributable to Ionis Common Stockholders

Ionis reported a GAAP net loss attributable to Ionis’ common stockholders of $1.4 million for the first quarter of 2018, compared to GAAP net income of $9.0 million for the same period in 2017. For the first quarter of 2018, basic and diluted net loss per share were $0.01. For the first quarter of 2017, basic and diluted net income per share were $0.07.

Webcast and Conference Call

Today, at 11:30 a.m. Eastern Time, Ionis will conduct a live webcast conference call to discuss this earnings release and related activities. Interested parties may listen to the call by dialing 877-443-5662 or access the webcast at www.ionispharma.com. A webcast replay will be available for a limited time.

On May 3, 2018 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the quarter ended March 31, 2018, provided a business update, and increased its full year 2018 financial guidance (Press release, AMAG Pharmaceuticals, MAY 3, 2018, View Source [SID1234526018]).

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!

Total GAAP revenue for the first quarter of 2018 increased to $146.4 million, 5% higher than the same period last year. The year-over-year increase was driven by the addition of Intrarosa (prasterone) to the product portfolio, as well as net sales growth from Makena (hydroxyprogesterone caproate injection) and Cord Blood Registry (CBR). The company reported an operating loss of $44.9 million in the first quarter of 2018, compared with an operating loss of $40.0 million in the same period last year. Non-GAAP adjusted EBITDA totaled $40.6 million in the first quarter of 2018, compared with $57.6 million in the first quarter of 2017.1

"Strong execution led to the achievement of a number of significant regulatory and business milestones in the first quarter of 2018, including two FDA approvals that provide an opportunity to broaden and extend the Makena and Feraheme brands," stated Bill Heiden, AMAG’s president and chief executive officer. "We’ve received positive initial market feedback on both the Makena subcutaneous auto-injector and Feraheme broad label launches, and continue to see good progress on the Intrarosa launch. During the first quarter, we also filed the new drug application for bremelanotide and we are initiating programs to educate healthcare providers about diagnosing hypoactive sexual desire disorder. These accomplishments, solid first quarter financial results, and our expectation for continued strong commercial execution allowed us to increase our 2018 full year financial guidance."

First Quarter 2018 and Recent Business Highlights:
•
Secured two U.S. Food and Drug Administration (FDA) approvals
–
Broad intravenous (IV) iron deficiency anemia (IDA) label for Feraheme (ferumoxytol injection)
–
Makena subcutaneous (SC) auto-injector
•
Submitted a new drug application (NDA) to the FDA for bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women
•
Maintained 50% Makena market share and launched the SC auto-injector (March 2018)
–
47% of new patient enrollments through the Makena Care Connection were prescribed the SC auto-injector in the week of April 23
•
Eight patents covering Makena SC auto-injector were listed in the FDA Orange Book, the last of which expires in 2036
•
Increased Intrarosa weekly market share to 2.8%, with approximately 50,000 total prescriptions written by more than 6,600 healthcare providers since the July 2017 launch
–
High gross-to-net adjustments (low net price) continued, but are expected to improve throughout 2018

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

1

•
Initiated first wave of multi-faceted Intrarosa digital direct-to-consumer program
•
Launched Feraheme with broad IV IDA label and already capturing additional share
•
Four successive quarters of year-over-year growth in new family enrollments at CBR, which are a strong indicator of upcoming new customer collections and revenues
•
Ended the quarter with $370.6 million of cash and investments, an increase of more than $40 million from year end
•
Increased 2018 full year financial guidance

First Quarter Ended March 31, 2018 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the first quarter of 2018 increased 5% to $146.4 million, compared with $139.5 million in the first quarter of 2017. Intrarosa, which was commercially launched in July 2017, contributed $2.2 million in net sales during the first quarter of 2018. Net product sales of Makena increased 4% to $90.0 million in the first quarter of 2018, compared with $86.5 million in the same period last year. Sales of Feraheme and MuGard decreased 3% to $25.2 million in the first quarter of 2018, compared with $26.1 million in the first quarter of 2017. The temporary shortage of saline caused by the 2017 hurricane destruction in Puerto Rico, a key manufacturing site for saline, negatively impacted Feraheme sales in the early weeks of the quarter. Service revenue from CBR increased 8% to $29.0 million in the first quarter of 2018, compared with $26.9 million in the same period last year, due in part to continued growth of new family enrollments.

Costs and expenses, including costs of product sales and services, totaled $191.2 million in the first quarter of 2018, compared with $179.5 million for the same period in 2017. This increase was primarily due to higher costs of products sold of $36.3 million, of which $31.5 million was an increase in amortization expense primarily related to the Makena intramuscular intangible asset, and higher selling, general and administrative (SG&A) expenses related to launch activities for the Feraheme expanded label, the Makena SC auto-injector and Intrarosa. The increase in total costs and expenses was partially offset by lower research and development expenses and lower acquired in-process research and development (IPR&D) expenses. Acquired IPR&D expense in 2017 consisted of a one-time, upfront payment of $60 million to Palatin for bremelanotide. Acquired IPR&D expense in 2018 consisted of a $20 million charge to recognize the contingent liability associated with the FDA acceptance milestone that the company expects to pay to Palatin.

The operating loss in the first quarter of 2018 was $44.9 million, compared to an operating loss of $40.0 million for the same period last year. The company reported a net loss of $54.2 million, or $1.59 loss per basic and diluted share, for the first quarter of 2018, compared with net loss of $36.6 million, or $1.06 loss per basic and diluted share for the same period in 2017.

Financial Results (Non-GAAP Basis)1
Going forward, the company will present GAAP revenue only, as historically the only difference between GAAP and non-GAAP revenue was an adjustment to purchase accounting related to CBR deferred revenue, which is now minimal.

Total costs and expenses on a non-GAAP basis totaled $105.7 million in the first quarter of 2018, compared with $83.2 million in the first quarter of 2017. This increase was primarily due to higher SG&A expenses related to investments the company is making to support the launches of the Feraheme broad label, Makena SC auto-injector and Intrarosa.

Non-GAAP adjusted EBITDA for the first quarter of 2018 was $40.6 million, compared to $57.6 million in the first quarter of 2017. Adjusted EBITDA for the first quarter of 2018 was in line with the company’s expectations and previously stated plans to invest in the continued development and commercialization of its newer and expanded products to create long-term shareholder value.

Balance Sheet Highlights

As of March 31, 2018, the company’s cash and investments totaled $370.6 million and total debt (principal amount outstanding) was $816.4 million.

"AMAG cleared a number of de-risking milestones during the first quarter of 2018, namely the approval and launch of the subcutaneous auto-injector in advance of potential generic competition and the approval and launch of the broad Feraheme label. These events combined with continued execution across the company give us conviction to increase our financial guidance for the full year," said Ted Myles, AMAG’s chief financial officer. "We believe we are well positioned, financially and operationally, to achieve our 2018 company goals, including the updated guidance. We will continue to invest in 2018 to build and grow a broad portfolio of differentiated long-lived assets that we believe will generate significant shareholder value."

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 first quarter 2018 financial results, recent business highlights and 2018 outlook.

Dial-in Number
U.S./Canada dial-in number: (877) 412-6083
International dial-in number: (702) 495-1202
Conference ID: 6978298

Replay dial-in number: (855) 859-2056
Replay International dial-in number: (404) 537-3406
Conference ID: 6978298

A telephone replay will be available from approximately 11:00 a.m. ET on May 3, 2018 through midnight on May 9, 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, non-GAAP costs and expenses 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 accompanying this press release after the unaudited condensed consolidated financial statements.

On May 3, 2018 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company seeking to advance innovative medicines in urology and rheumatology, reported financial results for the first quarter of 2018 and provided a corporate update on its near-term priorities (Press release, Apricus Biosciences, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346899 [SID1234526046]).

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!

"Since our recent end-of-review meeting on the NDA for Vitaros with the FDA, we have been focused on pursuing U.S. Vitaros partnership discussions with interested parties. Our objective is to enable continued development and potential approval of the Vitaros product and receive financial terms commensurate with this development stage asset in exchange for a sublicense or assignment of our U.S. development and/or commercialization rights. In parallel, the Company is evaluating strategic alternatives, which may include a sale of the company, a business combination, a merger or reverse merger or a license, and in order to maximize shareholder value, the Company has engaged Canaccord Genuity LLC to assist in that process," said Richard Pascoe, Chief Executive Officer.

First Quarter Financial Results

Net loss during the quarter ended March 31, 2018 was $2.3 million, or loss per share of $0.14, compared to net income of $8.1 million, or earnings per share of $1.04, during the first quarter of 2017. Net income during the quarter ended March 31, 2017 was primarily due to the $11.8 million gain recorded upon the sale of our ex-U.S. Vitaros rights and assets to Ferring.

For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations. As of March 31, 2018, the Company’s cash totaled $5.7 million, compared to $6.3 million as of December 31, 2016, which is expected to fund operations through the end of 2018. The Company’s cash balance as of March 31, 2018 does not include net proceeds of approximately $2.9 million from the Company’s public equity offering, which closed on April 2, 2018.

On May 3, 2018 IntelGenx Technologies Corp. (TSX VENTURE:IGX) (OTCQX:IGXT) reported that it will release its first quarter 2018 financial results after market close on May 10, 2018 (Press release, IntelGenx, MAY 3, 2018, View Source;Conference-Call-to-Follow/default.aspx [SID1234526073]).

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!

An accompanying conference call will be hosted by Dr. Horst G. Zerbe, President and Chief Executive Officer, and Mr. Andre Godin, Executive Vice-President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, May 10, 2018

Time: 4:30 p.m. ET

Conference dial-in: (833) 231-8269

International dial-in: (647) 689-4114

Conference ID: 2398086

Webcast Registration: Click here

Following the live call, a replay will be available on the Company’s website, www.intelgenx.com, under "Investor Relations".