On April 25, 2019 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that it is scheduled to report first quarter results on May 9, 2019 at 4:00 PM Eastern Time (Press release, Cytokinetics, APR 25, 2019, View Source [SID1234535418]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 4486595.

An archived replay of the webcast will be available via Cytokinetics’ website until May 16, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 4486595 from May 9, 2019 at 7:30 PM Eastern Time until May 16, 2019.

On April 25, 2019 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported financial results for the first quarter of 2019 (Press release, Alexion, APR 25, 2019, View Source [SID1234535384]). Total revenues in the first quarter were $1,140.4 million, a 23 percent increase compared to the same period in 2018. The negative impact of foreign currency on total revenues year-over-year was 1 percent, or $12.3 million, inclusive of hedging activities. On a GAAP basis, diluted EPS in the quarter was $2.61, a 135 percent increase versus the prior year. Non-GAAP diluted EPS for the first quarter of 2019 was $2.39, a 42 percent increase versus the first quarter of 2018.

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"We had a great start to 2019, with a strong launch in ULTOMIRIS’ first full quarter since FDA approval. We’ve also made significant progress executing and expanding our pipeline. This progress includes three business development deals, multiple filings under regulatory review and having begun dosing patients in two new ULTOMIRIS Phase 3 programs," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We look forward to continuing to build on our momentum as the year progresses, further growing our four durable franchises in hematology/nephrology, neurology, metabolics and FcRn."

First Quarter 2019 Financial Highlights

Total net product sales were $1,140.2 million in the first quarter of 2019, compared to $930.4 million in the first quarter of 2018.
SOLIRIS (eculizumab) net product sales were $962.0 million, compared to $800.1 million in the first quarter of 2018, representing a 20 percent increase. SOLIRIS volume increased 23 percent year-over-year.
ULTOMIRIS (ravulizumab-cwvz) net product sales were $24.6 million in its first full quarter since FDA approval.
STRENSIQ (asfotase alfa) net product sales were $130.1 million, compared to $110.7 million in the first quarter of 2018, representing an 18 percent increase. STRENSIQ volume increased 26 percent year-over-year.
KANUMA (sebelipase alfa) net product sales were $23.5 million, compared to $19.6 million in the first quarter of 2018, representing a 20 percent increase. KANUMA volume increased 28 percent year-over-year.
GAAP cost of sales was $85.8 million, compared to $91.6 million in the first quarter of 2018. Non-GAAP cost of sales was $82.1 million, compared to $83.0 million in the first quarter of 2018.
GAAP R&D expense was $195.9 million, compared to $176.6 million in the first quarter of 2018. Non-GAAP R&D expense was $159.4 million, compared to $161.6 million in the first quarter of 2018.
GAAP SG&A expense was $281.5 million, compared to $257.1 million in the first quarter of 2018. Non-GAAP SG&A expense was $243.7 million, compared to $220.4 million in the first quarter of 2018.
GAAP income tax benefit was $46.1 million, compared to income tax expense of $102.5 million in the first quarter of 2018. GAAP income tax benefit for the first quarter 2019 includes deferred tax benefits of $95.7 million and $30.3 million associated with a tax election related to intellectual property and release of an existing valuation allowance, respectively. Non-GAAP income tax expense was $100.9 million, compared to $68.6 million in the first quarter of 2018.
GAAP diluted EPS was $2.61, compared to $1.11 in the first quarter of 2018. GAAP diluted EPS for the first quarter 2019 includes deferred tax benefits of $95.7 million and $30.3 million associated with a tax election related to intellectual property and release of an existing valuation allowance, respectively. Non-GAAP diluted EPS was $2.39, compared to $1.68 in the first quarter of 2018.
Research and Development

PHASE 3

SOLIRIS – Neuromyelitis Optica Spectrum Disorder (NMOSD): In February 2019, Alexion announced that the U.S. Food and Drug Administration (FDA) granted Priority Review for SOLIRIS in NMOSD and set a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2019. Alexion has filed for regulatory approval in the European Union (EU) and Japan, and orphan drug priority review has been granted in Japan. These filings are based on previously announced results from the Phase 3 PREVENT study, in which 97.9 percent of patients with anti-aquaporin-4 (AQP4) auto antibody-positive NMOSD who received SOLIRIS on top of stable standard-of-care therapy were relapse free at 48 weeks compared to 63.2 percent of patients who received placebo.
ULTOMIRIS – Paroxysmal Nocturnal Hemoglobinuria (PNH): Applications for approval in the EU and Japan are currently under review. In addition, a Phase 3 study of ULTOMIRIS in children and adolescents with PNH is underway.
ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In April 2019, Alexion submitted an application in the U.S. for the approval of ULTOMIRIS in patients with aHUS. The filing was based on previously announced positive topline results from a Phase 3 study of ULTOMIRIS in complement inhibitor naïve patients with aHUS. Alexion plans to file for regulatory approval in the EU and Japan in 2019. In addition, a Phase 3 study of ULTOMIRIS in adolescents and children with aHUS is underway.
ULTOMIRIS – Subcutaneous: Enrollment and dosing are underway in a single, PK-based Phase 3 study of ULTOMIRIS delivered subcutaneously once per week to support registration in PNH and aHUS. Data are expected in early 2020.
ULTOMIRIS – Generalized Myasthenia Gravis (gMG): In the first quarter of 2019, Alexion initiated a Phase 3 study of ULTOMIRIS in gMG.
ULTOMIRIS – Neuromyelitis Optica Spectrum Disorder (NMOSD): Alexion plans to initiate a Phase 3 study of ULTOMIRIS in NMOSD by the end of 2019.
ALXN1840 (WTX101) – Wilson Disease: Enrollment and dosing are underway in a Phase 3 study of ALXN1840 (WTX101) in Wilson disease, a rare genetic disorder with devastating hepatic and neurological consequences. The study is now powered for superiority versus standard-of-care therapy. ALXN1840 is a first-in-class oral copper-binding agent with a unique mechanism of action to bind serum copper and promote its removal from the liver.

PHASE 1/2

ALXN1830 (SYNT001): Alexion plans to initiate two Phase 2/3 trials of ALXN1830 (SYNT001) in late 2019 or early 2020 – one in warm autoimmune hemolytic anemia (WAIHA) and one in gMG.
ALXN1810 – Subcutaneous: In the first quarter of 2019, Alexion completed dosing in a Phase 1 study of subcutaneous ALXN1210 co-administered with Halozyme’s ENHANZE drug-delivery technology, recombinant human hyaluronidase enzyme (rHuPH20), a next-generation subcutaneous formulation called ALXN1810.
ULTOMIRIS – Amyotrophic Lateral Sclerosis (ALS): Alexion plans to initiate a proof-of-concept study for ULTOMIRIS in ALS.
ULTOMIRIS – Primary Progressive Multiple Sclerosis (PPMS): Alexion plans to initiate an exploratory clinical study of ULTOMIRIS in PPMS.
Caelum Biosciences – CAEL-101 – Light Chain (AL) Amyloidosis: In January 2019, Alexion entered into a collaboration with Caelum Biosciences to develop CAEL-101 for AL amyloidosis, a rare systemic disorder that causes misfolded immunoglobulin light chain protein to build up in and around tissues, resulting in progressive and widespread organ damage. CAEL-101 is a first-in-class amyloid fibril targeted therapy designed to improve organ function by reducing or eliminating amyloid deposits in patients with AL amyloidosis. In a Phase 1a/1b study, CAEL-101 demonstrated improved organ function, including cardiac and renal function, in patients with relapsed and refractory AL amyloidosis. Pending regulatory feedback, a Phase 2/3 study investigating CAEL-101 as an add-on to current standard-of-care therapy is planned to begin in early 2020.
Affibody AB – ABY-039: In March 2019, Alexion announced a partnership with Affibody AB to co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated autoimmune diseases. Pending relevant regulatory approvals, the transaction is expected to close in the second quarter of 2019. Currently in Phase 1 development, ABY-039 is a bivalent antibody-mimetic that targets the neonatal Fc receptor (FcRn). ABY-039 has been specifically designed to combine Affibody’s protein therapeutics platform (Affibody molecules) and Albumod technology to achieve a long half-life, which, along with its small size provides the potential for less frequent, convenient, at-home subcutaneous administration.

PRE-CLINICAL

ALXN1720: In March 2019, Alexion announced the development of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that binds and prevents activation of human C5. Alexion plans to initiate a first-in-human study of ALXN1720 in late 2019.
Zealand Pharma A/S: In March 2019, Alexion began a collaboration with Zealand Pharma A/S to discover and develop novel peptide therapies for up to four targets in the complement pathway. Peptides offer a number of advantages, including being highly selective and potent, allowing low dosage volumes for ease of administration, and having the potential to treat a broad range of complement-mediated diseases.
Dicerna – GalXC: Alexion is collaborating with Dicerna Pharmaceuticals to jointly discover and develop up to four subcutaneously delivered GalXC RNA interference (RNAi) candidates, currently in pre-clinical development, for the treatment of complement-mediated diseases.
Complement Pharma – CP010: Alexion is collaborating with Complement Pharma to co-develop CP010, a pre-clinical C6 inhibitor that has the potential to treat multiple neurological disorders.

GAAP guidance reflects the financial impact of the announced collaboration with Affibody.
GAAP effective tax rate of 7 to 9 percent; non-GAAP effective tax rate of 14 to 16 percent.
Alexion’s financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of acquisitions, license and collaboration agreements, intangible asset impairments, litigation charges, changes in fair value of contingent consideration or restructuring and related activity outside of the previously announced activities that may occur after the issuance of this press release.

Conference Call/Webcast Information:

Alexion will host a conference call/audio webcast to discuss the first quarter 2019 results today at 8:00 a.m. Eastern Time. To participate in the call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 1692605 shortly before 8:00 a.m. Eastern Time. A replay of the call will be available for a limited period following the call. The audio webcast can be accessed on the Investor page of Alexion’s website at: View Source

On April 25, 2019 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported results for the first quarter of 2019 and increased its full-year 2019 earnings outlook (Press release, Baxter, APR 25, 2019, View Source [SID1234535400]).

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"We are pleased with the solid start to 2019, establishing a foundation for accelerating performance over the course of the year," said José (Joe) E. Almeida, chairman and chief executive officer. "Our first quarter results reflect the value of our diversified portfolio, an increased emphasis on high-value innovation and an ongoing focus on operational excellence. We remain committed to executing on our strategy to deliver enhanced performance in 2019 and beyond."

First-Quarter Financial Results

Worldwide sales in the first quarter totaled approximately $2.6 billion, a decrease of 2% on a reported basis and an increase of 2% on both a constant currency and an operational basis. Operational sales in the first quarter exclude the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

Sales in the U.S. totaled $1.1 billion, decreasing 2% on both a reported and operational basis. International sales of $1.5 billion decreased 1% on a reported basis and increased 5% on a constant currency basis.

Performance in the quarter was driven by growth of Baxter’s peritoneal dialysis and continuous renal replacement therapies, certain generic injectable pharmaceuticals, and hemostats and sealants. In addition, increased demand for Baxter’s hospital pharmacy compounding and cytotoxic contract manufacturing services also contributed to growth in the quarter. Sales growth in the quarter was partially offset by expected lower sales of Medication Delivery and Nutritional therapies. Baxter’s performance in International markets reflects growth across both the Europe, Middle East and Africa (EMEA) and Asia Pacific (APAC) regions.

Please see the attached schedules accompanying this press release for additional details on sales performance in the quarter, including breakouts by Baxter’s three geographic segments and six global business units (GBUs).

Baxter reported net income of $347 million, or $0.66 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the first quarter. These results include special items totaling $52 million after-tax, which were primarily related to business optimization charges and intangible asset amortization, partially offset by an insurance recovery from a legacy product-related matter. On an adjusted basis, Baxter’s first quarter net income totaled $399 million, or $0.76 per diluted share, ahead of the company’s expectations of $0.66 to $0.68 per diluted share. Adjusted earnings per diluted share advanced 9% in the quarter, driven by solid operational performance as well as benefits from a lower tax rate and share count as compared to the prior-year period.

Business Highlights

Baxter continues to achieve notable milestones in pursuit of its Mission for patients and emphasis on accelerating profitable growth. Among recent highlights, the company:

Launched ready-to-use eptifibatide, a platelet aggregation inhibitor that prevents platelets from sticking together and clotting, using the company’s proprietary GALAXY container technology. Baxter’s premix presentation is the first of its kind available in a flexible container, offering healthcare providers preparation efficiencies and helping to avoid potential dosing errors.
Announced U.S. Food and Drug Administration (FDA) approval for faster preparation of Floseal Hemostatic Matrix. This next generation of Floseal has 20% fewer components and steps to prepare,2 making it easier and faster for operating room nurses to get Floseal into the hands of surgeons to help stop bleeding during procedures.
Initiated a collaboration with bioMérieux, a world leader in the field of in vitro diagnostics, to develop future biomarkers with the goal of rapidly identifying and informing treatment of acute kidney injury (AKI). The efforts are meant to help diagnose AKI earlier so a patient can have improved therapy options, reflecting Baxter’s growth strategy of addressing patient needs across the continuum of care.
Announced that a NantHealth digital health solution is now available to connect Baxter’s Prismaflex technology, used in the intensive care unit to treat patients with acute kidney injury, to a hospital’s electronic medical record (EMR) system. Digitally connected healthcare solutions have the potential to positively impact patient care in many ways, from reducing reliance on manual documentation to converting data into meaningful insights to improve care.
Announced the planned U.S. launch of Clinolipid (20% Lipid Injectable Emulsion), Baxter’s proprietary olive oil-based lipid emulsion, later this year. The announcement was made at the 2019 ASPEN Nutrition Science & Practice Conference, where Baxter featured its diverse portfolio of parenteral nutrition products to address and help improve care for malnourished patients.
Received recognition from multiple organizations for its commitment to workplace excellence, including:
Forbes Magazine, which included Baxter on its annual list of America’s Best Large Employers for the fifth consecutive year.
The National Association for Female Executives (NAFE), which cited Baxter among its 2019 NAFE Top Companies for Executive Women.
The Human Rights Campaign Foundation (HRC), which cited Baxter as a 2019 Best Place to Work for LGBTQ Equality based on Baxter’s perfect score on HRC’s Corporate Equality Index.
2019 Financial Outlook

For full-year 2019: Based on solid first quarter performance, Baxter is raising its earnings outlook for 2019. The company now expects adjusted earnings from continuing operations, before special items, of $3.27 to $3.35 per diluted share. The company continues to expect sales growth of 0 to 1 percent on a reported basis, 2 to 3 percent on a constant currency basis and 3 to 4 percent on an operational basis.

For second-quarter 2019: The company expects sales to decline approximately 2 percent on a reported basis, and to grow approximately 2 percent on a constant currency basis and 2 to 3 percent on an operational basis. The company expects adjusted earnings from continuing operations, before special items, of $0.80 to $0.82 per diluted share.

Full-year and quarterly operational sales estimates for 2019 have been adjusted for the impact of foreign exchange and generic competition for U.S. cyclophosphamide.

A webcast of Baxter’s first-quarter 2019 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 25, 2019. Please see www.baxter.com for more information regarding this and future investor events and webcasts.

On April 25, 2019 Novavax, Inc. (Nasdaq: NVAX) reported it will report its first quarter 2019 financial and operating results following the close of U.S. financial markets on Thursday, May 2, 2019 (Press release, Novavax, APR 25, 2019, http://ir.novavax.com/news-releases/news-release-details/novavax-host-conference-call-discuss-first-quarter-financial-2 [SID1234535419]).

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Conference call details are as follows:

Date: May 2, 2019
Time: 4:30 p.m. U.S. Eastern Time (ET)
Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode: 5394082
Webcast: www.novavax.com, "Investors"/ "Events"

Conference call and webcast replay:

Dates: Starting at 7:30 p.m. ET, May 2, 2019 until 7:30 p.m. ET May 9, 2019
Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode: 5394082
Webcast: www.novavax.com, "Investors"/ "Events", until August 2, 2019

On April 25, 2019 Alkermes plc (Nasdaq: ALKS) reported financial results for the first quarter of 2019 (Press release, Alkermes, APR 25, 2019, View Source [SID1234535385]).

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"Our first quarter results reflect the diversity of our business, as the growth of VIVITROL net sales and royalty revenues from INVEGA SUSTENNA offset a decline in AMPYRA royalties, following generic entry in the market. As is typical, during the first quarter we saw the effect of seasonal inventory fluctuations and deductible resets for commercial payer plans impact net sales of our proprietary commercial products, which decreased sequentially. In particular, ARISTADA net sales were impacted more than anticipated by inventory fluctuations which masked underlying prescription growth of approximately 5% compared to last quarter," commented James Frates, Chief Financial Officer of Alkermes. "Today, we are reiterating our financial expectations for 2019, as we continue to position VIVITROL and ARISTADA for long-term growth, invest in our development pipeline and prepare for the potential launch of ALKS 3831."

"The first few months of 2019 were highlighted by the presentation of important new data from large clinical trials of both ALKS 3831 and ARISTADA at the 2019 Congress of the Schizophrenia International Research Society. These innovative studies demonstrated the clear antipsychotic efficacy of our medicines along with our intended patient-focused attributes relating to safety and tolerability. Our recently announced ALPINE study results also provide information useful to clinicians making treatment decisions for their patients," commented Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are focused on executing both commercially and across our development pipeline. With the planned submission of the New Drug Application for ALKS 3831 mid-year, expected regulatory action for diroximel fumarate for multiple sclerosis in the fourth quarter, and increasing momentum in the ALKS 4230 immuno-oncology program, we have a number of key milestones ahead and look forward to updating you on our progress throughout the year."

Quarter Ended Mar. 31, 2019 Financial Highlights

Total revenues for the quarter were $223.1 million, compared to $225.2 million for the same period in the prior year, reflecting the growth in our proprietary product net sales and an offsetting decrease in AMPYRAi revenues following generic entry into the market in 2018.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $96.4 million for the quarter, or a basic and diluted GAAP net loss per share of $0.62. This compared to GAAP net loss of $62.5 million, or a basic and diluted GAAP net loss per share of $0.40 for the same period in the prior year.

Non-GAAP net loss was $26.0 million for the quarter, or a non-GAAP basic and diluted net loss per share of $0.17. This compared to non-GAAP net loss of $14.2 million, or a non-GAAP basic and diluted net loss per share of $0.09 for the same period in the prior year.

Quarter Ended Mar. 31, 2019 Financial Results

Revenues

Net sales of VIVITROL were $69.2 million, compared to $62.7 million for the same period in the prior year, representing an increase of approximately 10%.

Net sales of ARISTADAii were $30.3 million, compared to $29.2 million for the same period in the prior year, representing an increase of approximately 4%.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $75.6 million, compared to $68.8 million for the same period in the prior year.

Manufacturing and royalty revenues from AMPYRA/FAMPYRA were $12.2 million, compared to $28.3 million for the same period in the prior year due to generic competition to AMPYRA entering the market in late 2018.

Research and development revenues from the collaboration with Biogen for diroximel fumarate (BIIB098) were $13.9 million, compared to $17.5 million for the same period in the prior year.

Costs and Expenses

Operating expenses were $299.1 million, compared to $287.0 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of VIVITROL and ARISTADA.

Other expense during the quarter included a $22.6 million charge due to a decrease in the fair value of contingent consideration, related to Recro Pharma, Inc.’s receipt of a second complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for IV Meloxicam.

Financial Expectations for 2019

Alkermes reiterates its financial expectations for 2019 set forth in its press release dated Feb. 14, 2019.

Recent Events:

Leadership

Appointed Todd Nichols to the role of Senior Vice President of Sales and Marketing. Mr. Nichols joins Alkermes from Celgene and his responsibilities will include leading global commercial activities, including marketing and sales of VIVITROL and ARISTADA, as well as developing and executing the commercial strategy for ALKS 3831 and other development candidates.

ARISTADA

The U.S. Department of Veterans Affairs recently added ARISTADA and ARISTADA INITIO to its National Formulary at parity with other long-acting injectable atypical antipsychotics.

Announced positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a six-month study evaluating the efficacy, safety and tolerability of ARISTADA and INVEGA SUSTENNA, when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Results were presented at the 2019 Congress of the Schizophrenia International Research Society (SIRS).

ALKS 3831

Presented new data at SIRS from the phase 3 ALKS 3831 ENLIGHTEN-2 six-month weight study and interim results from the ENLIGHTEN-2 52-week safety extension

study.

Diroximel fumarate

Announced that the FDA accepted for review the NDA for diroximel fumarate. If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY, which has been conditionally accepted by the FDA and would be confirmed upon approval.

ALKS 4230

Initiated ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with advanced solid tumors.

Announced a research collaboration with Clovis to evaluate ALKS 4230 in combination with rucaparib, Clovis’ marketed PARP inhibitor, and lucitanib, Clovis’ investigational tyrosine kinase inhibitor.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Apr. 25, 2019, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Apr. 25, 2019, through Thursday, May 2, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13690081