Proposed Acquisition of Shire plc by Takeda

On May 8, 2018 Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") and Shire plc (LON: SHP) ("Shire") reported that they have reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire (Press release, Takeda, MAY 8, 2018, View Source [SID1234526178]). Under the terms of the acquisition, each Shire shareholder will be entitled to receive $30.33 in cash for each Shire share and either 0.839 new Takeda shares or 1.678 Takeda ADSs. The transaction has been approved by both companies’ boards of directors, and is expected to close in the first half of calendar year 2019. Upon the closing of the transaction, Takeda shareholders will own approximately 50 percent of the combined group.

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With leading market positions in prioritized therapeutic areas, an attractive geographic footprint, greater scale and efficiencies, and an even more productive R&D engine, the combined group will be better positioned to deliver highly-innovative medicines and transformative care providing better health and a brighter future for patients around the world.

"Since its inception, Takeda has transformed into an agile, R&D-driven global pharmaceutical company that is well-positioned to deliver innovative and transformative care to patients around the world," said Christophe Weber, president and chief executive officer of Takeda. "Shire’s highly complementary product portfolio and pipeline, as well as experienced employees, will accelerate our transformation for a stronger Takeda. Together, we will be a leader in providing targeted treatments in gastroenterology, neuroscience, oncology, rare diseases and plasma-derived therapies. We are looking forward to the benefits this combination will bring to patients worldwide, the opportunities it will bring for our employees and the returns it will deliver for our shareholders."

Susan Kilsby, chairman of Shire, said, "Over the last 30 years, Shire has become the global leader in treating rare diseases, delivering innovative products that transform patients’ lives. With this combination, Shire helps create an even stronger biopharmaceutical company, with a robust R&D pipeline and expanded global footprint. We are proud of what Shire has become and are grateful to all Shire employees for their contributions. We firmly believe that this combination recognizes the strong growth potential of our leading products and innovative pipeline and is in the best interests of our shareholders, our patients and the communities we serve."

Flemming Ornskov, chief executive officer of Shire, said, "I would like to thank the entire Shire team for all that we have accomplished over the last five years to transform Shire into a leading rare disease biotech company and a tenacious champion for patients in need. I am confident that this relentless focus will enable us to continue delivering against our priorities throughout this process. With a truly innovative portfolio and pipeline, I believe that the combination of the two companies is in the best interests of shareholders and offers an opportunity to improve the lives of even more patients globally with rare and highly specialized conditions."

Highly Compelling Strategic and Financial Rationale

Brings together complementary positions in GI and neuroscience; provides leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines

The acquisition of Shire will accelerate Takeda’s transformation by bringing together Takeda and Shire’s complementary positions in GI and neuroscience. It will also provide the combined group with leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines. Takeda will continue to focus on the acceleration of its oncology business, following its recent acquisition of ARIAD Pharmaceuticals. In addition, Takeda’s vaccine business will continue to address the world’s most pressing public health needs.

Creates a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, with an attractive geographic footprint and provides the scale to drive future development

The acquisition will build on Takeda’s long Japanese heritage and values-based culture to create a global biopharmaceutical leader, driven by innovative and world-class R&D. The combined group will have an attractive geographic footprint, with significantly increased exposure in the United States (U.S.), an important and growing market. In addition, Shire’s portfolio will benefit from Takeda’s strong international presence in emerging markets and Japan. The integrated company will continue to be headquartered in Japan, expand its R&D presence in the Boston area and have major regional locations in Japan, Singapore, Switzerland and the U.S. Together, the combined group will have leading positions in two of the largest drug markets globally: the U.S. and Japan. The acquisition is expected to result in Takeda being the only pharmaceutical company listed on both the Tokyo Stock Exchange in Japan, where it will continue to have its primary listing, and the NYSE in the U.S., enabling it to access two of the world’s largest capital markets.

Creates a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation

Takeda and Shire have highly complementary pipelines. Shire has strong expertise in rare diseases, an attractive modality-diverse mid- and late-stage pipeline, enriched with large-molecule programs, as well as cutting-edge technologies in gene therapy and recombinant proteins. Combining this with Takeda’s early development and research-oriented R&D program will result in a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation. The combined group will build on existing partnerships, including Takeda’s more than 180 active partnerships with academia, biotechnology companies and startups, to further enrich the pipeline.

Enhances Takeda’s cash flow profile, with management committed to delivering substantial annual cost synergies and generating attractive returns for shareholders

The acquisition of Shire will provide compelling financial benefits for the combined group. It will be significantly accretive to underlying earnings per share from the first full fiscal year following completion, and will produce strong combined cash flows. The transaction is also expected to result in attractive returns for shareholders, with the return on invested capital (ROIC) expected to exceed Takeda’s cost of capital within the first full fiscal year following completion. The substantial cash flow generation expected to result from the acquisition will enable the combined group to de-lever quickly following completion. Takeda intends to maintain its investment grade credit rating, with a target net debt to EBITDA ratio of 2.0x or less in the medium term.

Takeda is confident that the acquisition will create an opportunity to recognize significant recurring cost synergies, with potential for additional revenue synergies from the combination of Shire and Takeda’s combined infrastructure, market presence and development capabilities. Takeda expects recurring pre-tax cost synergies for the combined group to reach a run-rate of at least $1.4 billion per annum by the end of the third fiscal year following completion of the acquisition.

The acquisition will accelerate Takeda’s strategic transformation toward Vision 2025, and strong combined cash flows will enable continued investment in R&D. Takeda’s well-established dividend policy will remain a key component of future shareholder returns.

Execution

Takeda’s experienced management team has a proven track record of executing complex business integrations and large-scale transformations, and is well-positioned to successfully integrate Shire and maximize the value of the combination. The integration will be supported by the companies’ highly complementary organizational structures in geographic areas, including hubs in the Boston area, Switzerland and Singapore, as well as similar therapeutic area focus and complementary approaches to R&D. Takeda is dedicated to carrying out integration efforts in a manner consistent with the company’s core values of integrity, fairness, honesty and perseverance, building on the expertise of employees of both companies.

Transaction Terms

Under the terms of the acquisition, Shire shareholders will be entitled to receive, for each Shire share, $30.33 in cash and either 0.839 new Takeda shares or 1.678 Takeda ADSs.

The acquisition terms imply an equivalent value of:

£48.17 per Shire share based on the closing price of ¥4,535 per Takeda share on May 2, 2018, and the exchange rates of £:¥ of 1:147.61 and £:$ of 1:1.3546 on May 4, 2018 (being the latest practicable date prior to this announcement); and
£49.01 per Shire share based on the closing price of ¥4,923 per Takeda Share and the exchange rates of £:¥ of 1:151.51 and £:$ of 1:1.3945 on April 23, 2018 (being the day prior to the announcement that the Shire board would, in principle, be willing to recommend the consideration).

The equivalent value of £49.01 per Shire share values the entire issued and to be issued ordinary share capital of Shire at approximately £46 billion.

Immediately following completion of the transaction, Takeda shareholders will hold approximately 50 percent of the combined group.

The transaction has been approved by the boards of both companies, and is subject to the approval of Shire and Takeda shareholders and certain customary closing conditions, including regulatory approvals.

The acquisition is expected to close in the first half of calendar year 2019. Upon completion, the new Takeda shares will be listed on the Tokyo Stock Exchange, and local Japanese stock exchanges. In addition, Takeda will apply for its ADSs (each representing 0.5 Takeda shares) to be listed on the NYSE effective on or shortly after the effective date.

Financing

Takeda has entered into a bridge facility agreement of $30.85 billion with, among others, J.P. Morgan Chase Bank N.A., Sumitomo Mitsui Banking Corporation and MUFG Bank, Ltd., part of the proceeds of which will be used to fund the cash consideration payable to Shire shareholders in connection with the acquisition. It is currently contemplated that, prior to completion, the commitments under the bridge facility agreement will be reduced or refinanced with a combination of long-term debt, hybrid capital and available cash resources.

Conference Call Webcast Information

Takeda will host a transaction conference call at 4.15pm – 5pm JST / 8.15am – 9am BST / 3.15am – 4am EST on May 8, 2018 to discuss the transaction.

Investors and analysts can dial in to the conference call using the numbers below:

Standard International Access: +44 (0) 20 3003 2666; Japan Toll Free: 006633132499; UK Toll Free: 0808 109 0700; USA Toll Free: 1 866 966 5335; Tokyo Toll Free: +81 (0) 3 5050 5366; and Passcode: 161017

A presentation for the call will be available at:

View Source

Takeda will host an additional audio webcast at 10.00 p.m. JST / 2.00 p.m. BST / 9.00 a.m. ET on May 8, 2018 with Japanese translation, to discuss the transaction. The webcast can be accessed at the following link:

View Source

Replays of the conference calls will be available within 24 hours.

For more information, the full Rule 2.7 announcement setting out full details of the offer to Shire shareholders is available at: View Source

Editas Medicine to Present at the Bank of America Merrill Lynch 2018 Health Care Conference

On May 8, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that it will participate in a fireside chat at the Bank of America Merrill Lynch 2018 Health Care Conference on Tuesday, May 15, 2018, at 8 a.m. PT (11:00 a.m. ET) in Las Vegas, Nevada (Press release, Editas Medicine, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347637 [SID1234526203]).

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A live webcast of the presentation will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com. An archived replay will be available for approximately 30 days following the presentation.

Infinity Announces Presentations On IPI-549 At Upcoming American Society of Clinical Oncology Annual Meeting

On May 8, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing IPI-549, a first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that data from the ongoing clinical trial of IPI-549 will be presented in three events on June 4th during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Infinity Pharmaceuticals, MAY 8, 2018, View Source [SID1234526233]).

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Investor Event 6:30 a.m. CT – 7:30 a.m. CT
Infinity Pharmaceuticals will host an investor event on Monday, June 4, 2018, from 6:30 a.m. CT – 7:30 a.m. CT, with Dr. Ryan Sullivan from Massachusetts General Hospital, an investigator on the IPI-549 Phase 1/1b study, to review the IPI-549 data being presented at ASCO (Free ASCO Whitepaper). The event will be webcast live and can be accessed on the Investors/Media section of Infinity’s website at www.infi.com for 30 days following the event.

Poster Session 8:00 a.m. CT – 11:00 a.m. CT
Title: Initial results from first-in-human study of IPI-549, a tumor macrophage-targeting agent, combined with nivolumab in advanced solid tumors.
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: Monday, June 4, 2018, 8:00 a.m. CT – 11:00 a.m. CT
Poster Board: 227
Abstract Number: 3013
First Author:Ryan J. Sullivan, MD, Massachusetts General Hospital
Location: Hall A, McCormick Place convention center

Poster Discussion Session 11:30 a.m. CT – 12:45 p.m. CT
Title: Initial results from first-in-human study of IPI-549, a tumor macrophage-targeting agent, combined with nivolumab in advanced solid tumors.
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: Monday, June 4, 2018, 11:30 a.m. CT – 12:45 p.m. CT
Abstract Number: 3013
First Author:Ryan J. Sullivan, MD, Massachusetts General Hospital
Location: Hall B1, McCormick Place convention center

About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.[i], [ii] As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.[iii] The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

Cerus Corporation Reports First Quarter 2018 Results

On may 8, 2018 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2018, and raised its full year guidance for product revenue (Press release, Cerus, MAY 8, 2018, View Source [SID1234526249]).

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First Quarter Highlights and Recent Events

First quarter product revenue of $13.6 million

Year-over-year Q1 worldwide disposable kit volume up over 100%

Raising full year product revenue guidance range to $53 million to $55 million from $51 million to $53 million

Cash and cash equivalents balance of $105.9 million at March 31, 2018

Received Canadian regulatory approval for INTERCEPT Blood Systems for platelets

Expanded enrollment sites for the phase 3 RedeS clinical trial of INTERCEPT-treated red blood cells into Texas and Florida
"The commercial momentum we experienced exiting 2017 continued into 2018 with first quarter product revenue of $13.6 million, exceeding our expectations. Global demand for platelet kits continued to be robust with first quarter platelet kit sales volumes more than doubling compared to the prior year, led by increased shipments in France and in the U.S.," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Given the strong first quarter results and the current visibility into our commercial pipeline, we are raising our full year product revenue guidance range to $53 million to $55 million compared to our previous range of $51 million to $53 million."

"We continue to push forward with our mission to establish INTERCEPT as the global standard of care for transfused blood components," continued Greenman. "In the U.S., blood centers are continuing to increase production of INTERCEPT platelets to meet the ever growing hospital demand for pathogen-reduced platelets. In France, we gained additional regulatory approvals on our dual storage processing set for INTERCEPT platelets and shelf-life extension from five to seven days which should allow for increased blood center operational efficiencies and lower product wastage."

During the quarter, the Company’s development programs continued to progress with the Ultra-Performance Liquid Chromatography (UPLC) lot release assay achieving validation to support its anticipated CE Mark submission for INTERCEPT red cells, and the INTERCEPT cryoprecipitate program advancing the required stability studies for its planned premarket approval (PMA) supplement submission to the U.S. Food and Drug Administration (FDA).

Revenue

Product revenue for the first quarter of 2018 was $13.6 million, compared to $7.0 million during the same period in 2017. The increase in product revenue was driven by quarter-over-quarter increases in platelet kit demand, partially offset by declines in plasma kits and illuminator sales. Reported product revenue in the quarter also benefitted from favorable foreign currency exchange rates.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $3.5 million in the first quarter of 2018 compared to $1.4 million during the same period in 2017 as a result of increasing INTERCEPT red cell clinical and development activities. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Gross Margins

Gross margins on product revenue for the first quarter of 2018 were 46%, compared to 47% for the first quarter of 2017. Gross margins on product sales remained relatively stable due to a variety of factors including economies of scale and lower costs due to increased platelet production, pricing for high volume customers, and foreign exchange rates.

Operating Expenses

Total operating expenses were $23.0 million for the quarter ended March 31, 2018, compared to $22.8 million for the quarter ended March 31, 2017.

Selling, general, and administrative expenses for the first quarter of 2018 remained relatively flat at $13.6 million, compared to $13.7 million for the first quarter of 2017 as the Company continued to leverage its existing commercial and back-office infrastructure.

Research and development (R&D) expenses for the first quarter of 2018 were $9.4 million compared to $9.2 million for the first quarter of 2017. Expenses associated with the clinical development of the Company’s INTERCEPT red blood cell program increased while non-BARDA related R&D expenses declined as the Company re-allocated R&D personnel to the BARDA activities.

Operating and Net Loss

Operating losses during the first quarter of 2018 were $13.4 million, compared to $18.1 million during the first quarter of 2017.

Net loss for the first quarter of 2018 was $13.9 million, or $0.11 per diluted share, compared to a net loss of $18.6 million, or $0.18 per diluted share, for the first quarter of 2017.

Cash, Cash Equivalents and Investments

At March 31, 2018, the Company had cash, cash equivalents and short-term investments of $105.9 million compared to $60.7 million at December 31, 2017.

At March 31, 2018, the Company had approximately $29.8 million in outstanding debt under its loan agreement with Oxford Finance. The loan agreement provides for an additional $10 million term loan (and, if drawn, an extension of the interest only period) upon the Company achieving pre-determined revenue levels. The Company achieved the pre-determined revenue levels as of March 31, 2018, but has not currently exercised its option on the additional $10 million term loan and interest only extension. The option expires on May 14, 2018.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2366225. The replay will be available approximately three hours after the call through May 22, 2018.

LYNPARZA® (olaparib) Tablets Receive EU Approval for the Treatment of Platinum-Sensitive Relapsed Ovarian Cancer

On May 8,2018 AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the European Medicines Agency (EMA) has approved LYNPARZA (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status (Press release, Merck & Co, MAY 8, 2018, View Source [SID1234526267]).

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Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca, said, "With this new approval for LYNPARZA, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterized safety and tolerability profile."

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease. Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women."

The EU approval was based on two randomized trials, SOLO-2 and Study 19, which showed that LYNPARZA reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.