Alkermes’ Corporate Presentation to be Webcast at the UBS Global Healthcare Conference

On May 14, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the UBS Global Healthcare Conference on Monday, May 21, 2018 at 2:00 p.m. ET (7:00 p.m. BST) from New York the UBS Global Healthcare Conference on Monday, May 21, 2018. The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

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Investor Relations
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Takeda reports FY2017 full year results and issues FY2018 guidance

On May 14, 2018 FY2017 performance reflects superior execution (Press release, Takeda, May 14, 2018, View Source [SID1234526592])
– Underlying results: Revenue +5.5%, Core Earnings +40.2%, Core EPS +44.8%
– Takeda will maintain its underlying growth momentum in FY2018

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Underlying Revenue growth +5.5% led by Takeda’s Growth Drivers
• Underlying Revenue grew +5.5%, with Takeda’s Growth Drivers (Gastroenterology, Oncology, Neuroscience and Emerging Markets) posting strong underlying revenue growth of +12.8%.
• Broad based revenue performance was led by double digit growth in the U.S. (U.S. +13.5%, Japan -0.2%, Europe & Canada +6.7%, Emerging Markets +2.0%; Japan growth was +7.0% excluding returned portfolio)
• Reported revenue grew +2.2%, with underlying growth (+5.5%) and positive currency impact (+2.5pp), partly offset by the impact of divestitures (-5.8pp).

Stellar EPS growth reflects strong revenue growth and progress of Global Opex Initiative
• Underlying Core Earnings grew +40.2%, with the Core Earnings margin increasing by 420bps due to product mix improvement and strong cost discipline (+280bps gross margin; +160bps from OPEX margin). Reported operating profit was up +55.1%, mainly driven by Core Earnings growth. In FY2017, Takeda booked a large one-time gain of 106.3 billion yen from the sale of Wako; however, higher one-time expenses resulted in total other income/expenses being less favorable than prior year by-27.8 billion yen.
• Underlying Core EPS was up +44.8%, in-line with underlying Core Earnings growth. Reported EPS was 239 yen, an increase of +62.7% from 147 yen in the prior year, benefitting also from a lower tax rate due to re-measurement of deferred tax liabilities as a result of the U.S. tax reform.

Significant pipeline progress leveraging therapeutic area expertise
• 17 New Molecular Entity clinical stage-ups in FY2017, compared with 5 in the same period of the previous year. Important events included European Commission approval of ALOFISEL (darvadstrocel) in the area of GI, a label update for TRINTELLIX in neuroscience, and the initiation of Phase 3 for pevonedistat in oncology.
• Further strengthened innovation network with 56 new collaborations with academia and bio-tech/bio-ventures.

Net leverage improved due to continued strong progress on cash flow
• Operating Free Cash Flow was up +52.9% to 242.9 billion yen, higher than the dividend payment for the third consecutive year. Non-core asset sales generated an additional 164.4 billion yen of cash.
• Strong cash generation allowed rapid de-leveraging with the net debt/EBITDA ratio improving from 2.7x in March 2017 to 1.8x in March 2018.

Christophe Weber, President and Chief Executive Officer of Takeda, commented:

"Takeda’s transformation is delivering superior results as we execute against our key mid-term priorities of growing the portfolio, strengthening the pipeline, and boosting profitability. In FY2017, our Growth Drivers maintained their strong momentum, which together with disciplined cost management under the Global Opex Initiative resulted in industry-leading revenue and earnings growth. We also made significant progress in R&D, with 17 New Molecular Entity clinical trial stage-ups, and 56 new collaborations to strengthen our innovation network.
The strength of the underlying business means we expect to maintain revenue and earnings growth momentum in FY2018, and I am confident that through strategic focus and superior execution, Takeda will continue to deliver long-term value to patients and shareholders."

Core Earnings is calculated by deducting SG&A expenses and R&D expenses from reported Gross Profit. In addition, certain other items that are non-core in nature and significant in value may also be adjusted.

2 Underlying growth compares two periods of financial results on a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures.
3 Attributable to the owners of the company.

FY2018 Management Guidance: Maintaining underlying growth momentum
• Underlying revenue continues to grow despite negative headwinds of -4.4pp that include Velcade decline due to competitor entry (-3.5pp) and portfolio changes (-0.9pp).
• Continued product mix improvement and execution of the Global Opex Initiative will underpin margin improvement. Underlying Core Earnings margin to expand at lower end of the +100-200bps range bringing the 2-year margin expansion to more than 500 basis points.
• Underlying Core Earnings will grow high single digit, despite Velcade decline which negatively impacts Core Earnings growth by over 18 percentage points.
• Annual dividend of 180 yen per share, in-line with Takeda’s well-established dividend policy of being strongly committed to shareholder returns with the dividend as a key component.

FY2018 Reported Forecast: Underlying strength lessens impact of significant decline in one-time items
• Underlying revenue growth momentum offset by Forex and divestitures.
• Excluding the negative impact of Forex and divestitures, Core Earnings growth is forecast to be high single digit.
• Reported operating profit is impacted by lower other income (-40.9pp, especially the 106.3 billion yen gain on the sale of Wako in FY2017) and the impact of divestitures (-9.6pp).

Takeda is currently in an offer period (as defined in the City Code on Takeovers and Mergers (the "Code")) with respect to Shire plc. Pursuant to Rule 28 of the Code, statements made regarding Takeda’s guidance for FY2018 (including statements regarding forecasts for FY2018 revenue, Core Earnings, Operating profit, Profit before income taxes, Net profit attributable to owners of the Company, Basic earnings per share, R&D expenses, Amortisation and impairment and other income/expense, Underlying Revenue, Underlying Core Earnings and Underlying Core EPS) constitute a profit forecast for the year ending March 31, 2019 (the "Takeda Profit Forecast"). For additional information regarding the Takeda Profit Forecast and the required statement by its Directors that such profit forecast is valid and has been properly compiled on the basis of the assumptions stated and that the basis of accounting used in consistent with Takeda’s accounting policies, please see page 21 of Takeda’s Financial Results (Tanshin) for the Fiscal Year Ended March 31, 2018, dated May 14, 2018.

Raising our objectives for non-core asset disposals by the end of FY2018
• Revised objective is to unlock 190 billion yen of cash by the end of FY2018 from real estate disposals and the sale of securities, increased from 130 billion yen guidance given in May 2017.

Immunicom’s Immunotherapy Product Receives U.S. FDA Breakthrough Device Designation for the Treatment of Cancer

On May 14, 2018 Immunicom, Inc., a medical technology company developing revolutionary non-pharmaceutical approaches for treating cancer and autoimmune diseases, reported the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from a patient’s bloodstream potentially enabling their natural immune system to more-effectively attack cancer tumors (Press release, Immunicom, MAY 14, 2018, View Source [SID1234637423]).

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To achieve Breakthrough Device designation, a technology must demonstrate compelling potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.

The FDA’s intent in granting this specific designation to qualified devices is to collaboratively facilitate expediting the device’s assessment and review processes through more interactive communication and planning with the FDA; ensuring proper data collection, efficient clinical study design, senior management engagement of Agency personnel, and priority review of applicable filings.

In contrast to immunotherapy pharmaceuticals and biologicals that introduce foreign compounds and material into a patient’s body, and which are often accompanied by negative side effects, Immunicom’s patented technology is based on a "subtractive" approach that is intended to potentially limit treatment-associated adverse effects. By removing immune system inhibitors from the blood without introducing new substances, Immunicom’s therapeutic approach has been shown in preliminary preclinical studies to enhance anti-cancer immune system response without causing unwanted side effects.

Immunicom’s blood-filtering device technology is the first step in execution of a broader corporate strategic vision. "We are very pleased with FDA’s granting of Breakthrough Device designation for Immunopheresis, our initial immunotherapy product for treating late/end stage IV cancer patients with metastatic solid tumors," said Amir Jafri, CEO of Immunicom, "This significant milestone will enable us to more efficiently pursue device regulatory approval and address critical unmet patient needs sooner, while also continuing our commitment to invest in other exciting treatment options in our product pipeline."

Alpine Immune Sciences Provides Corporate Update and Reports First Quarter 2018 Financial Results

On May 14, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer, autoimmune/inflammatory, and other diseases, reported financial results for the first quarter ended March 31, 2018 (Press release, Alpine Immune Sciences, MAY 14, 2018, View Source [SID1234526574]).

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"We are increasingly encouraged by our promising preclinical results, which demonstrate the potential of our platform to change the way we approach and treat both cancer and autoimmune/inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We continue to make progress on our lead programs and remain on track to file INDs for ALPN-101, a dual ICOS/CD28 antagonist for the treatment of autoimmune/inflammatory diseases in the fourth quarter of this year, and ALPN-202, our lead oncology program, in 2019."

Corporate and Scientific Development Highlights

Presentation of ALPN-202 immuno-oncology program data: Alpine’s poster at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting debuted preclinical data for the ALPN-202 program, representing a potentially novel immuno-oncology approach to the treatment of cancer. Results demonstrated molecules in the ALPN-202 program are able to antagonize PD-L1 and CTLA-4 while providing a CD28 costimulatory signal, resulting in the elimination of tumors, complete resistance to tumor rechallenge, and superiority to an approved anti PD-L1 therapeutic in a murine cancer model. The potentially unique mechanism of ALPN-202 seeks to address the lack of costimulatory activity in many current immuno-oncology therapies and may improve the immune system’s response to cancer. With preclinical results demonstrating both checkpoint blockade and immune system costimulation, Alpine’s ALPN-202 program could potentially be a more potent and broadly applicable therapeutic for the treatment of cancer.

Chris Peetz appointed to Board of Directors: On April 24, 2018, Alpine announced the appointment of Chris Peetz to its Board of Directors. Currently serving as Chief Executive Officer of Flashlight Therapeutics, Mr. Peetz is an experienced life sciences executive. He previously served as Chief Financial Officer and Head of Corporate Development at Tobira Therapeutics (acquired by Allergan in November 2016) and, prior to that, held senior management roles at Jennerex Biotherapeutics and Onyx Pharmaceuticals (now Amgen). Earlier, he was at LaSalle Corporate Finance, Abgenix, and Solazyme.

First Quarter 2018 Financial Results

Alpine ended the first quarter of 2018 with $76.7 million in cash, cash equivalents, and short-term investments compared to $81.2 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $4.4 million.
Revenue for the first quarter of 2018 was $0.3 million compared to $0.7 million in the first quarter of 2017. The decrease was primarily attributable to the timing of revenue recognized under Alpine’s collaboration agreement with Kite Pharma, a Gilead (NASDAQ:GILD) company. As previously announced, under the terms of the research collaboration and license agreement with Kite, which was extended on October 30, 2017, Alpine received upfront payments of $5.5 million, which were initially recorded as deferred revenue and expensed over the period of the research term.
Research and development expenses for the first quarter of 2018 were $3.8 million compared to $1.9 million for the same period in 2017. The $1.9 million increase was primarily attributable to increased activity in preclinical studies and the addition of operational and research personnel related to expanding research and discovery programs.
General and administrative expenses for the first quarter of 2018 were $2.1 million compared to $0.9 million for the same period in 2017. The $1.2 million increase was primarily attributable to higher professional and legal service fees and increased headcount to support our operations as a public company.
Cash Guidance

The company expects to have cash to fund operations into 2020, including the clinical advancement of ALPN-101 for the treatment of autoimmune/inflammatory diseases and ALPN-202 for the treatment of cancer.

BMG Pharma: GelX® Approved in Europe for Prevention of Oral Mucositis in Cancer Patients

On May 14, 2018 BMG Pharma S.r.l., an innovative specialty pharmaceutical company, reported the European regulatory approval for its GelX product to be used for the prevention of oral mucositis (Press release, BMG PHARMA, MAY 14, 2018, View Source [SID1234526593]).

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This new regulatory approval for GelX is the first for a medical product to be used for both the treatment and prevention of oral mucositis in cancer patients.

The approval is based on clinical data, (conducted under Good Clinical Practice(GCP) principles) from 149 adult and paediatric patients showing unique results with 99,3% of patients experiencing prevention or remission of oral mucositis during cancer therapy.

This new approval will allow patients to receive cancer treatment with a significantly reduced chance of developing oral mucositis during that treatment and to reduce the grade of oral mucositis, allowing the opportunity for normal eating and drinking.

Marco Mastrodonato, Founder and CEO of BMG Pharma S.r.l. commented– "We achieved a unique milestones by giving the opportunity to cancer patients to prevent Oral Mucositis in both adults and children which will allow them to continue with a complete nutritional program while under cancer treatment. GelX will be available through its partners to over 1.1m patients in the 7 major markets, suffering from oral mucositis as a side-effect of cancer and transplants treatment.’’

GelX Oral Gel and GelX Oral Spray are proprietary products of BMG Pharma Srl, which thanks to their innovative formula alleviate pain in cancer patients, offering unique solutions for chemotherapy & radiation induced oral mucositis.