On January 14, 2020 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported that it will provide an update on the progress of its business transformation and priorities today at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Takeda, JAN 14, 2020, View Source [SID1234553185]). President and Chief Executive Officer, Christophe Weber, will share details on Takeda’s portfolio and pipeline strategy, financial outlook, and ongoing sustainability efforts, including its newly established commitment to carbon neutrality across its value chain.

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"Last year was an important and successful year for Takeda as we accelerated our transformation to become a leading global biopharmaceutical company," said Mr. Weber. "Our commitment to bringing better health and a brighter future to patients worldwide continues as we expand our global brands and advance our next-generation pipeline, driving sustainable growth. We also recognize that supporting our patients means we must commit to work on behalf of the broader global community – and one way to do this is by accelerating our environmental efforts."

Commercial Strategy and Innovative Pipeline

As highlighted at its recent R&D Investor Day event in November 2019, Takeda continues to generate significant opportunities through new indications and geographic expansion of its 14 global brands. By cultivating the best science through its research and development engine, comprised of internal capabilities and external partnerships, Takeda is quickly advancing a steady stream of next-generation therapies designed to provide transformative or curative potential for targeted populations with high unmet medical needs in its core therapeutic areas of oncology, rare diseases, neuroscience and gastroenterology.

Over the next several years, Takeda’s pipeline is projected to deliver value with a focus on the potential launches of 12 unique new molecular entities (NMEs) in 14 indications, which represent best-in-class or first-in-class therapies to advance patient standard of care, and that have the potential to deliver more than $10 billion (USD) in aggregate peak sales.

Takeda is confident in its ability to execute in the near-term and achieve sustainable growth through 2024 and beyond, with its portfolio of 14 global brands and additional anticipated product launches intended to fuel its growth trajectory while its next-generation platforms mature.

Additional Highlights include:

~40 NME clinical stage assets; 17 NMEs in Phase 2 and Phase 3
≥15 potential new launches within the next five years in China
8 potential best-in-class/first-in-class NMEs in pivotal studies
~50% of pipeline with orphan drug designation
Diversified modalities in research, including cell and gene therapies, small molecules and biologics
Financial Strength

Takeda is committed to maintaining investment grade credit ratings and remains on track towards its target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years ending March 2022 to March 2024, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first six months of FY19, Takeda reduced its Net Debt/adjusted EBITDA ratio from 4.7x to 3.9x. In addition, four non-core asset divestitures were announced that, together with other potential divestments, are expected to reach $10 billion (USD).

Through expected cost synergies from the acquisition of Shire that are expected to reach a run rate of approximately $2 billion (USD) annually and operating expenditure efficiencies, Takeda is also driving towards its target of a mid-30% underlying core operating profit margin within the fiscal years ending March 2022 through March 2024. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually.

Values-Driven Commitment to ESG (Environment, Social, Governance)

Recognizing that climate change poses a risk to human health, including the spread of infectious diseases, Takeda has made environmental efforts a priority. To date, Takeda has met and exceeded its previously established 2020 environmental goals ahead of schedule, including reducing its CO2 emissions by 33.7% compared to 2005 levels. Furthering the Company’s commitment to the environment, today Takeda will unveil its new 2040 targets to achieve carbon neutrality across its value chain. Takeda intends to do this by eliminating all greenhouse gas (GHG) emissions from its operations (Scopes 1 and 2), working with its suppliers to significantly reduce their emissions (Scope 3), and addressing remaining Scope 3 emissions through verified carbon offsets. Beginning with FY19 GHG emissions, the Company commits to carbon neutrality (Scopes 1, 2, and 3) through the purchase of renewable energy and verified carbon offsets, while simultaneously working to reduce emissions from its operations and suppliers.

In addition to Takeda’s environmental efforts, its overall commitment to ESG – including the Access to Medicines Strategy and Global Corporate Social Responsibility (CSR) Program – has been recognized by multiple benchmark ESG indices. Since 2014, Takeda has risen 15 spots to No. 5 in the latest Access to Medicines Index, which measures commitment and achievements in the field of patient access to medicine and treatment globally. Takeda is proud to have provided access to innovative and potentially life-saving treatments to more than 125,000 patients. In addition, its CSR Program has committed over $100 million (USD) to organizations that work to prevent diseases and improve health outcomes around the world. Takeda is proud that employees are engaged and select the organizations that the CSR Program supports. Takeda’s 2019 Sustainable Value Report provides additional details on the its commitment to ESG.

On January 14, 2020 Distributed Bio, a global leader in computational optimization of fully human monoclonal antibody libraries, is reported a multi target research collaboration with John DiPersio, MD, PhD, Chief of the Division of Oncology at Washington University School of Medicine and Deputy Director of the Alvin J. Siteman Cancer Center in St. Louis (Press release, Distributed Bio, JAN 14, 2020, View Source [SID1234553184]). Distributed Bio will use its proprietary SuperHuman antibody discovery and engineering platform to discover and optimize therapeutics in collaboration with Dr. DiPersio.

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"We are delighted to collaborate with Dr. DiPersio on antibody discovery," says Jacob Glanville, Co-Founder and Chief Executive Officer of Distributed Bio. "The SuperHuman Platform represents the culmination of a decade of our research in computational library design. From analyzing thousands of human immune systems with our machine learning AbGenesis platform, we have harvested from nature the rules of making exceptional therapeutic repertoires. The result is a library of 76 billion antibodies that contains over 5,000 hits against any antigen, thermostable, non-immunogenic, pre-screened by human blood and therapeutically developed in advance to avoid engineering delays downstream. This is an order of magnitude more molecules than can be generated by other technologies, and enables our partners to search for ultra-specific, species-cross reactive therapeutic antibodies at unprecedented speeds. The libraries overcome many of the limitations of other monoclonal generation technologies that have resulted in a unique engineering opportunity: a library that can generate unique and developable hits against every antigen tested, enabling routine success against targets that used to be nearly insurmountable – GPCRs, Ion Channels, pMHC complexes, broadly-neutralizing antibodies against HIV, therapeutic anti-idiotypic antibodies, bi-epitopic antibodies, and mouse/NHP/human cross-reactive antibodies."

Under the terms of the collaboration, Distributed Bio will use its SuperHuman antibody library to discover novel therapeutic antibodies to targets selected by Dr. DiPersio and will also use its Tumbler technology to optimize clones that he already has identified. The lead clones will then be further developed by Dr. DiPersio.

On January 14, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that following discussions with investors it has received commitments for an investment of €0.5 million through a private placement (Press release, NOXXON, JAN 14, 2020, View Source [SID1234553182]).

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"We are pleased with the ongoing support of the investment community, in particular the long-term investors from Europe and the US who continue to support NOXXON’s strategy and also invested in the capital increases last year. This investment provides additional capital for the company and allows us to advance the Phase 1/2 trial of NOX-A12 in combination with radiotherapy as a 1st line treatment in brain cancer patients, which is one of the key clinical goals for NOXXON. As with the previous private placement, for which we have attracted long-term equity investors, there are no warrants or other option-like instruments attached to this financing," said Aram Mangasarian, CEO of NOXXON.

The price agreed with investors of €0.51 per share represents a 26% discount on the average closing price of the shares over the seven trading days from December 31, 2019, to January 9, 2020. As such, it is anticipated that 980,389 new shares will be issued in the context of this financing. Closing and settlement of this transaction is expected within the next seven days.

On January 14, 2020 A2A Pharmaceuticals Inc. (A2A) reported an agreement to design and co-develop oncology drug candidates with Daewoong Pharmaceutical Co., Ltd. (Daewoong), a major pharmaceutical company in South Korea, using its proprietary AI-enabled drug discovery platform SCULPT (Press release, A2A Pharmaceuticals, JAN 14, 2020, View Source [SID1234553181]). The companies will collaborate on up to three oncology drug targets to accelerate Daewoong’s efforts to develop innovative oncology treatments through open collaboration.

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Under this collaboration, A2A will use its computational drug discovery platform to design new compound structures, which will be synthesized and evaluated by Daewoong. Both parties will actively cooperate in preclinical optimization and selection of lead candidates to enter the clinic.

A2A will receive upfront and preclinical milestones for each discovery target under the agreement, and could receive clinical and commercialization milestones, and royalties. A2A will have the option to develop compounds from the collaboration that Daewoong decides not to pursue.

"A2A’s technology has demonstrated success going after difficult-to-drug targets in diseases with high unmet needs for patients", said A2A CEO, Dr. Sotirios Stergiopoulos. He added "We’re excited to embark on this collaborative journey with Daewoong, combining our strengths to bring high quality drugs to the patients who need them faster."

With this partnership, Daewoong expects to expand its portfolio in oncology, while also to secure a successful case of AI-based drug development, which has been emerging as a recent pharmaceutical industry trend. There is justified precedent, because compared to traditional new drug development processes, A2A’s proprietary SCULPT platform will generate higher quality new drug candidates while greatly reducing the time and cost of development.

"Even though it is still in its very early stages, the development of new AI-based drugs is rising globally" said Sengho Jeon, CEO of Daewoong, "This open-collaboration between Daewoong’s strong expertise in new drug development and A2A’s SCULPT platform technology will significantly enhance the competitiveness of Daewoong in the oncology market."

On January 14, 2020 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that it commenced a "modified Dutch auction" tender offer to purchase up to $420,000,000 of its common shares, or such lesser number of common shares as are properly tendered and not properly withdrawn, at a price not less than $30.00 nor greater than $33.00 per common share, to the seller in cash, less any applicable withholding taxes and without interest (the "Offer") (Press release, XBiotech, JAN 14, 2020, View Source [SID1234553180]). The Offer is made upon the terms and subject to the conditions described in the offer to purchase and in the related letter of transmittal. The closing price of XBiotech’s common shares on the NASDAQ Global Select Market on January 13, 2020, the last full trading day before the commencement of the Offer, was $18.62 per share. The Offer is scheduled to expire at 5:00 p.m., New York City time, on February 12, 2020, unless the Offer is extended.

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XBiotech believes that the Offer represents an efficient mechanism to provide XBiotech’s stockholders with the opportunity to tender all or a portion of their stock and thereby receive a return of some or all of their investment in XBiotech if they so elect. The Offer provides stockholders with an opportunity to obtain liquidity with respect to all or a portion of their stock without the potential disruption to XBiotech’s stock price.

The Offer is not contingent upon obtaining any financing. However, the Offer is subject to a number of other terms and conditions, which are described in detail in the offer to purchase. Specific instructions and a complete explanation of the terms and conditions of the Offer will be contained in the offer to purchase, the letter of transmittal and the related materials, which will be mailed to stockholders of record shortly after commencement of the Offer.

None of XBiotech, the members of its Board of Directors (including the Independent Committee who authorized the Offer), the information agent or the depositary makes any recommendation as to whether any stockholder should participate or refrain from participating in the Offer or as to the price or prices at which stockholders may choose to tender their shares in the Offer.

D.F. King & Co., Inc. will serve as information agent for the Offer. Stockholders with questions, or who would like to receive additional copies of the Offer documents may call D.F. King at (212) 269-5550 (banks and brokers) or (866) 856-3065 (all others).