On February 3, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, President and Chief Operating Officer, will transition to the role of Chief Executive Officer, effective today (Press release, Syndax, FEB 3, 2022, View Source [SID1234607684]). Briggs W. Morrison, M.D., Chief Executive Officer, will transition to the role of President, Head of Research and Development (R&D) . Mr. Metzger and Dr. Morrison will remain on the Company’s Board of Directors. Both Mr. Metzger and Dr. Morrison joined Syndax together in 2015 with the goal of building a world-class oncology company.

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"Briggs and I have worked very closely in partnership over the last seven years to expand Syndax’s portfolio of assets through business development transactions while simultaneously building the organization, developing the pipeline, and executing on key capital raising initiatives," said Mr. Metzger. "This transition will better align our roles and priorities with our individual areas of expertise. Going forward, I will be focused on executing on the strategic vision for the Company, including establishing the operational groundwork to expand Syndax into a commercial entity and growing our pipeline through transactions. Briggs will continue to lead the R&D organization, with a key focus on bringing two assets to approval and helping to bring new assets into the organization. I look forward to our continued partnership as we work to deliver innovative therapies to areas of high unmet need in oncology and build long-term value for all of our stakeholders."

"With topline data expected early next year for both of our ongoing SNDX-5613 and axatilimab registration programs, we are keenly focused on preparations for multiple potential New Drug Application filings in 2023," said Dr. Morrison. "I look forward to focusing my efforts, together with the talented team at Syndax, on developing these exciting product candidates into approved therapies and to advancing them into new indications in the clinic, including the first-line and maintenance settings for SNDX-5613 in acute leukemia, and in idiopathic pulmonary fibrosis for axatilimab. We expect this transition of roles to be seamless, and I look forward to continuing to partner with Michael as we work to advance our mission of realizing a future in which people with cancer live longer and better than ever before."

Prior to joining Syndax, Mr. Metzger served as President, Chief Executive Officer and a Director of Regado Biosciences through its merger with Tobira Therapeutics (acquired by Allergan). He has also served in senior leadership and business development roles at Mersana Therapeutics, Forest Laboratories (acquired by Allergan), and in various other industry and investment roles. He received a B.A. from George Washington University and an M.B.A. in finance from the New York University Stern School of Business.

Prior to Syndax, Dr. Morrison served in several senior leadership roles in the industry, including as Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, Head, Medical Affairs, Safety and Regulatory Affairs at Pfizer, and Vice President, Clinical Sciences, Oncology, at Merck & Co. He received a B.S. in biology from Georgetown University and an M.D. from the University of Connecticut.

On February 3, 2022 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that members of its management team will participate in virtual fireside chats at the following investor conferences (Press release, Invitae, FEB 3, 2022, View Source [SID1234607683]):

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

SVB Leerink 11th Annual Global Healthcare Conference on Thursday, February 17, 2022, at 1:00 p.m. Eastern Time.
Cowen 42nd Annual Health Care Conference on Monday, March 7, 2022, at 11:10am Eastern Time.
A live webcast of each fireside chat may be accessed by visiting the investors section of the company website at ir.invitae.com. Replays of the webcasts will be available shortly after the conclusion of each fireside chat.

On February 3, 2022 Amgen (NASDAQ:AMGN) reported that it will host a virtual Business Review Meeting at 8:00 a.m. ET on Tuesday, Feb. 8, 2022 (Press release, Amgen, FEB 3, 2022, View Source [SID1234607682]). Robert A. Bradway, chairman and chief executive officer, along with other members of Amgen’s management team, will present a comprehensive review of the company’s strategy, operations, pipeline, research capabilities and growth outlook. The Business Review Meeting will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected webcasts and presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under the Investors tab.

Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On February 3, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2021 and forecasts for the fiscal year ending December 31, 2022 (Press release, Chugai, FEB 3, 2022, View Source [SID1234607681]).

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"2021 marked a successful first year of Chugai’s growth strategy TOP I 2030. We achieved record-high revenues and profits for the fifth consecutive year, and strategies in each business area made steady progress. In terms of financial performance, mainstay products such as Hemlibra, Tecentriq, and a new product Enspryng drove revenue growth in addition to the contribution of four newly launched products, including antibody cocktail Ronapreve for COVID-19. In R&D, the first project in mid-size molecules, a top priority for Chugai, entered the clinical development phase, enhancing our substantial pipeline of approximately 70 projects in a variety of modalities. In 2022, revenues are forecasted to exceed one trillion yen for the first time. Also, we’re aiming to make a full-scale entry into the ophthalmology field with faricimab, for which a regulatory application was filed last year. Moreover, the construction of our new core research laboratory, Chugai Life Science Park Yokohama, will finally be completed in October. We will continue pursuing innovation in order to provide better value to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported financial results for 2021 (Core-basis) with revenues of ¥999.8 billion (+¥212.9 billion, +27.1%). Sales and royalties and other operating income both increased by less than 30%. Domestic sales were ¥518.9 billion (+¥109.8 billion, +26.8%), driven by strong sales of mainstay products such as Tecentriq and Kadcyla in the oncology field, and Hemlibra and Actemra in the primary field. Penetration of new products, Enspryng, Polivy and Evrysdi, and the supply of Ronapreve to the government also contributed as well as an increase in comprehensive genomic profiling tests including the blood-based FoundationOne Liquid CDx cancer genomic profile. Overseas sales were ¥283.9 billion (+¥59.7 billion, +26.6%). In addition to the foreign exchange impact of a depreciation of the yen compared to the previous year, significant growth of Hemlibra due to full-scale export at regular shipment price and the strong sales of Alecensa outweighed the significant decline in Actemra (which is owing to the previous year’s significant increase in sales for reasons including clinical trials for COVID-19 pneumonia). Royalties and other operating income increased by less than 30%, mainly due to a significant increase in Hemlibra’s royalty and profit-sharing income, despite a decrease in one-time income.
The cost to sales ratio improved by 1.2% points year-on-year to 41.8%, mainly due to changes in the product mix. Marketing and distribution, research and development, and general and administration expenses have increased, resulting in an overall increase of operating expenses by approximately 10%. Marketing and distribution expenses increased due to promotion of digital marketing. Research and development expenses increased due to progress of projects. General and administration expenses increased due to the enterprise tax and various expenses. As a result, Core operating profit totaled ¥434.1 billion (+¥126.2 billion, +41.0%).

Reflecting the favorable results and based on our dividend policy, Chugai plans to pay year-end dividends of ¥46 per share. As a result, the annual dividend will be ¥76 per share, and the Core dividend payout ratio is 42.9% on a five-year average basis (40.1% on a single fiscal year basis).

Regarding research and development, the Company made good progress in both early and late-stage development toward achieving the two goals stated in TOP I 2030 – "Double R&D output" and "Launch in-house global products every year." As for in-house projects, which will be the foundation for future growth, an anti-cancer agent LUNA18 entered the clinical development phase as the first mid-size molecule project, which Chugai has been focusing on as its third modality following antibodies and small molecule drugs. There was also progress in projects applying Chugai’s proprietary antibody engineering technologies. Global phase III clinical trials started for Enspryng in generalized myasthenia gravis (gMG) and crovalimab in atypical hemolytic uremic syndrome (aHUS). A new investigational anti-cancer agent SOF10 entered the clinical development phase. In addition, Chugai filed a regulatory application for its mainstay product Hemlibra, for an additional indication of acquired hemophilia A. As for in-licensed projects, Chugai submitted a regulatory application for faricimab for two indications (diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD)), aiming full-scale entry in the ophthalmology field. Chugai in-licensed a project with a new modality from Roche, an investigational gene therapy SRP-9001, which is under development for Duchenne muscular dystrophy (DMD) by Sarepta Therapeutics. Furthermore, regulatory applications were filed for line extensions of Polivy and Tecentriq, respectively, both in the oncology field.

In the efforts to develop treatments for COVID-19, Chugai’s anti-IL-6 receptor monoclonal antibody Actemra was authorized for emergency use in the United States and approved in Europe for severe COVID-19 in 2021. In Japan, the drug was approved for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention) in January 2022. As for Ronapreve, the antibody cocktail in-licensed from Roche, Chugai received special approval in July and additional approval for prophylaxis and subcutaneous injection in November 2021.

In 2022, the Company expects revenues and profits to mark a record high for the sixth consecutive year. Revenues, Core operating profit, and Core net income are expected to be ¥1,150.0 billion (+¥150.2 billion, +15.0%), ¥440.0 billion (+¥5.9 billion, +1.4%), and ¥312.5 billion (+¥1.0 billion, +0.3%), respectively. Sales are expected to increase both in Japan and overseas, totaling ¥1,031.5 billion (+¥228.7 billion, +28.5%). New products (such as Ronapreve, Enspryng, Polivy, and Evrysdi) and mainstay products including Hemlibra are expected to drive the growth of domestic sales despite impacts from biosimilars and generics as well as NHI drug price revisions. Overseas sales of Hemlibra are expected to increase by approximately 60% as exports at regular shipment price started in the previous year. Likewise, overseas sales of Actemra are expected to increase by approximately 40% due to increased demand for COVID-19. Royalties and other operating income are expected to decrease significantly to ¥118.5 billion (-¥78.4 billion, -39.8%) due to decreases in royalty related to the stock of initial shipment of Hemlibra and one-time income.

For the fiscal year 2022, Chugai expects the annual dividends per share of ¥76 with the Core dividend payout ratio of 41.9% on a five-year average basis (40.0% on a single fiscal year basis).

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On February 3, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2021 and forecasts for the fiscal year ending December 31, 2022 (Press release, Chugai, FEB 3, 2022, View Source [SID1234607681]).

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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

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"2021 marked a successful first year of Chugai’s growth strategy TOP I 2030. We achieved record-high revenues and profits for the fifth consecutive year, and strategies in each business area made steady progress. In terms of financial performance, mainstay products such as Hemlibra, Tecentriq, and a new product Enspryng drove revenue growth in addition to the contribution of four newly launched products, including antibody cocktail Ronapreve for COVID-19. In R&D, the first project in mid-size molecules, a top priority for Chugai, entered the clinical development phase, enhancing our substantial pipeline of approximately 70 projects in a variety of modalities. In 2022, revenues are forecasted to exceed one trillion yen for the first time. Also, we’re aiming to make a full-scale entry into the ophthalmology field with faricimab, for which a regulatory application was filed last year. Moreover, the construction of our new core research laboratory, Chugai Life Science Park Yokohama, will finally be completed in October. We will continue pursuing innovation in order to provide better value to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported financial results for 2021 (Core-basis) with revenues of ¥999.8 billion (+¥212.9 billion, +27.1%). Sales and royalties and other operating income both increased by less than 30%. Domestic sales were ¥518.9 billion (+¥109.8 billion, +26.8%), driven by strong sales of mainstay products such as Tecentriq and Kadcyla in the oncology field, and Hemlibra and Actemra in the primary field. Penetration of new products, Enspryng, Polivy and Evrysdi, and the supply of Ronapreve to the government also contributed as well as an increase in comprehensive genomic profiling tests including the blood-based FoundationOne Liquid CDx cancer genomic profile. Overseas sales were ¥283.9 billion (+¥59.7 billion, +26.6%). In addition to the foreign exchange impact of a depreciation of the yen compared to the previous year, significant growth of Hemlibra due to full-scale export at regular shipment price and the strong sales of Alecensa outweighed the significant decline in Actemra (which is owing to the previous year’s significant increase in sales for reasons including clinical trials for COVID-19 pneumonia). Royalties and other operating income increased by less than 30%, mainly due to a significant increase in Hemlibra’s royalty and profit-sharing income, despite a decrease in one-time income.
The cost to sales ratio improved by 1.2% points year-on-year to 41.8%, mainly due to changes in the product mix. Marketing and distribution, research and development, and general and administration expenses have increased, resulting in an overall increase of operating expenses by approximately 10%. Marketing and distribution expenses increased due to promotion of digital marketing. Research and development expenses increased due to progress of projects. General and administration expenses increased due to the enterprise tax and various expenses. As a result, Core operating profit totaled ¥434.1 billion (+¥126.2 billion, +41.0%).

Reflecting the favorable results and based on our dividend policy, Chugai plans to pay year-end dividends of ¥46 per share. As a result, the annual dividend will be ¥76 per share, and the Core dividend payout ratio is 42.9% on a five-year average basis (40.1% on a single fiscal year basis).

Regarding research and development, the Company made good progress in both early and late-stage development toward achieving the two goals stated in TOP I 2030 – "Double R&D output" and "Launch in-house global products every year." As for in-house projects, which will be the foundation for future growth, an anti-cancer agent LUNA18 entered the clinical development phase as the first mid-size molecule project, which Chugai has been focusing on as its third modality following antibodies and small molecule drugs. There was also progress in projects applying Chugai’s proprietary antibody engineering technologies. Global phase III clinical trials started for Enspryng in generalized myasthenia gravis (gMG) and crovalimab in atypical hemolytic uremic syndrome (aHUS). A new investigational anti-cancer agent SOF10 entered the clinical development phase. In addition, Chugai filed a regulatory application for its mainstay product Hemlibra, for an additional indication of acquired hemophilia A. As for in-licensed projects, Chugai submitted a regulatory application for faricimab for two indications (diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD)), aiming full-scale entry in the ophthalmology field. Chugai in-licensed a project with a new modality from Roche, an investigational gene therapy SRP-9001, which is under development for Duchenne muscular dystrophy (DMD) by Sarepta Therapeutics. Furthermore, regulatory applications were filed for line extensions of Polivy and Tecentriq, respectively, both in the oncology field.

In the efforts to develop treatments for COVID-19, Chugai’s anti-IL-6 receptor monoclonal antibody Actemra was authorized for emergency use in the United States and approved in Europe for severe COVID-19 in 2021. In Japan, the drug was approved for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention) in January 2022. As for Ronapreve, the antibody cocktail in-licensed from Roche, Chugai received special approval in July and additional approval for prophylaxis and subcutaneous injection in November 2021.

In 2022, the Company expects revenues and profits to mark a record high for the sixth consecutive year. Revenues, Core operating profit, and Core net income are expected to be ¥1,150.0 billion (+¥150.2 billion, +15.0%), ¥440.0 billion (+¥5.9 billion, +1.4%), and ¥312.5 billion (+¥1.0 billion, +0.3%), respectively. Sales are expected to increase both in Japan and overseas, totaling ¥1,031.5 billion (+¥228.7 billion, +28.5%). New products (such as Ronapreve, Enspryng, Polivy, and Evrysdi) and mainstay products including Hemlibra are expected to drive the growth of domestic sales despite impacts from biosimilars and generics as well as NHI drug price revisions. Overseas sales of Hemlibra are expected to increase by approximately 60% as exports at regular shipment price started in the previous year. Likewise, overseas sales of Actemra are expected to increase by approximately 40% due to increased demand for COVID-19. Royalties and other operating income are expected to decrease significantly to ¥118.5 billion (-¥78.4 billion, -39.8%) due to decreases in royalty related to the stock of initial shipment of Hemlibra and one-time income.

For the fiscal year 2022, Chugai expects the annual dividends per share of ¥76 with the Core dividend payout ratio of 41.9% on a five-year average basis (40.0% on a single fiscal year basis).

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.