On February 3, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported two subscription agreements with Gaoling and YHG, a company of Hillhouse Capital Group, and Vivo Opportunity Fund, L.P, a company of Vivo Capital VIII, LLC (Press release, InnoCare Pharma, FEB 3, 2021, View Source [SID1234574706]). The two investors subscribed 191,613,000 and 18,895,000 new shares respectively, for a total of 210,508,000 new Shares, representing about 16.33% of the existing total issued Shares of the Company as at the date of this announcement and approximately 14.04% of the total issued Shares of the Company as enlarged by the allotment and issue of the Subscription Shares. The subscription price of HK$14.45 per share represents an 8.32% premium to the average closing price of the five trading days immediately preceding the date of the Subscription Agreements (not including 2 February 2021).

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Hillhouse Capital has adhered to the philosophy of value investment, and Vivo Capital focuses on investing in high-quality companies in the fields of life science and healthcare. The two investors are fully in line with InnoCare’s core value of "Science Drives Innovation".

InnoCare has built an integrated new drug development platform and continues to build a more competitive product pipeline. In addition to the self-developed Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib, which was approved for marketing at the end of last year, InnoCare has developed over a balanced pipeline of 10 drug candidates for the treatment of malignant tumors and autoimmune diseases. For example, the company’s pan-FGFR inhibitor ICP-192, which is currently in being studied two phase II clinical trials for the treatment of cholangiocarcinoma and urothelial carcinoma in China, has shown promising early efficacy data in patients with FGFR gene alterations. At the same time, InnoCare is also conducting phase I clinical trials of ICP-192 in the United States. Second-generation pan-TRK inhibitor ICP-723 is in phase I clinical trials in China for the treatment of advanced or metastatic solid tumors carrying NTRK fusion genes, which include indications such as breast cancer, colorectal cancer, lung cancer, thyroid cancer, etc., as well as patients who are resistant to the first generation of TRK inhibitors. In addition, InnoCare has been conducting multi-center and multi-indication clinical trials of orelabrutinib in China and the United States, including a global phase II clinical trial for the treatment of multiple sclerosis.

Based on the long-term investments, Hillhouse Capital has attached great importance to the biotech sector and values company’s long-term growth capabilities. The strategic investment from Hillhouse demonstrated the recognition of InnoCare’s strong innovation capabilities.

As one of InnoCare’s early and cornerstone investors, Vivo Capital has shared many experiences and resources with InnoCare, helping the company become a leader in the innovative drug field.

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, "I am very pleased that Hillhouse Capital has joined as a strategic investor. At the same time, Vivo Capital has increased its holdings. The biotech industry needs continuous innovation and capital support. We believe that, through our joint efforts, InnoCare will develop more high-quality innovative drugs to benefit patients in China and around the world."

On February 3, 2021 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it will be announcing its final results for the year ended December 31, 2020 on Thursday, March 4, 2021 at 12:00 noon Greenwich Mean Time (GMT) / 8:00 pm Hong Kong Time (HKT) / 7:00 am Eastern Standard Time (EST) (Press release, Hutchison China MediTech, FEB 3, 2021, View Source [SID1234574561]).

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Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by Chi-Med management.

The conference call and audio webcast will take place at 1:00 pm GMT / 9:00 pm HKT / 8:00 am EST on Thursday, March 4, 2021 and will be webcast live via the company website at www.chi-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.

On February 3, 2021 Indapta Therapeutics Inc. ("Indapta"), a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcRγ-deficient natural killer (G-NK) cell therapy to treat multiple cancers, reported the appointments of Lori Kunkel, M.D., as its Senior Clinical Advisor, Robert Sikorski, M.D., Ph.D., as its Founding Chief Medical Officer, and Jim Weiss as a member of its Board of Directors (Press release, Indapta Therapeutics, FEB 3, 2021, View Source [SID1234574578]).

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"I’m delighted to welcome these industry veterans to our team at this exciting time in Indapta’s evolution into the clinic," said Guy DiPierro, Chief Executive Officer and Founder of Indapta. "Lori and Bob bring vast and relevant clinical experience and strategic expertise to help shepherd Indapta through our clinical trials in multiple indications and phases of development. Dr. Kunkel’s knowledge of oncology drug development and commercialization, along with Dr. Sikorski’s extensive cell therapy experience, will help accelerate our clinical programs in multiple cancer types. And Jim Weiss will bring data-driven digitally-based commercial strategy, marketing and communications savvy as product development and launches become increasingly virtual in the post pandemic landscape."

Dr. Kunkel has more than two decades of experience in oncology and immunology drug development and commercialization. Previously, she was the acting Chief Medical Officer at Loxo Oncology, which was acquired by Eli Lilly, and subsequently served on the Board of Directors. Earlier, she served as Chief Medical Officer at Pharmacyclics, which was acquired by AbbVie, and at Proteolix, Inc., which was acquired by Onyx Pharmaceuticals, which in turn was acquired by Amgen, where she contributed to the global approvals of cancer therapeutics IMBRUVICA and Kyprolis. Dr. Kunkel spent 10 years in academic medicine and served as a faculty member at the Bone Marrow Transplant Unit in the Division of Hematology/Oncology at the University of California, Los Angeles. She currently serves on the Boards of Directors of Curis, Inc., Nurix Therapeutics, OricPharma and Maverick Therapeutics.

"Indapta’s promising preclinical data combined with its proprietary manufacturing process and its innovative management team is what drew me to the company," said Dr. Kunkel. "I’m looking forward to working with Guy, the management team and Board members and applying my experience to position Indapta’s products in the current therapy regimen, design the clinical trials, work with the FDA, and help rapidly advance Indapta’s G-NK cell therapy through the clinic and too approval."

Dr. Sikorski has extensive drug development experience, having most recently served as Chief Medical Officer at FivePrime Therapeutics, a public biotechnology company, where he led the development of a biologics pipeline that spanned preclinical discovery through proof of concept to pivotal trials. Previously, he led an early-stage clinical development group at Medimmune/AstraZeneca that advanced six novel molecules into clinical trials. He played a leading role in building Medimmune/AstraZeneca’s oncology portfolio through corporate partnering and acquisition efforts. Earlier in his career, he led late-stage clinical development and post marketing efforts for several commercial drugs and drug candidates at Amgen. He began his career as a Howard Hughes Research Fellow and Visiting Scientist at the National Cancer Institute and the National Human Genome Research Institute in the laboratory of Nobel Laureate Harold Varmus. Dr. Sikorski has served as an editor for Science and the Journal of the American Medical Association.

"The team at Indapta has developed a novel and powerful allogeneic NK cell product and manufacturing process that could serve as a platform for multiple next-generation anti-cancer therapies," said Dr. Sikorski. "I’m excited by the opportunity to bring this cutting-edge science to the treatment of cancer patients."

Mr. Weiss has 30 years of experience in strategic media and marketing communications in the healthcare and technology sectors and has been involved in nearly every aspect of corporate, product and organizational communications. He is the Founder and Chief Executive Officer of W2O, the leading independent provider of analytics-driven, digital-first marketing and communications to the healthcare sector. During his career, Mr. Weiss has been recognized as one of the most influential people in health communications, receiving many accolades, including Top 50 Health Influencer and Top 25 Innovator in Communications. He began his career at Genentech during its formative commercial years. Mr. Weiss currently serves on the Board of Trustees of the Cancer Research Institute and The Commons Project and is an Advisory Board member of both the Newhouse School and the Healthcare Businesswomen’s Association.

"Jim has advised me at numerous companies, from private to public, and from preclinical to commercial, driving value through key inflection points," said Dov Goldstein, M.D., Chief Financial and Business Officer of Indapta. "A founder and owner of a company that has grown to include more than 1,500 employees, Jim understands how to scale and evolve a company through various stages of success. We know our efforts at Indapta will benefit from his insights while serving on our Board."

Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change, rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation than multiple monoclonal antibody therapies alone or monoclonal antibody therapies combined with conventional NK cells.

When a monoclonal antibody binds to the tumor target and to Indapta’s G-NK cell therapy product, it initiates the release of dramatically more cancer killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety of Indapta’s G-NK cell therapy.

On February 3, 2021 Boston Scientific Corporation (NYSE: BSX) reported that net sales of $2.708 billion during the fourth quarter of 2020 (Press release, Boston Scientific, FEB 3, 2021, View Source [SID1234574562]). This represents a decline of (6.8) percent on a reported basis, (8.3) percent on an operational1 basis and (8.0) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 370 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device. The company reported GAAP net income available to common stockholders of $138 million or $0.10 per share (EPS), compared to GAAP net income of $3.996 billion or $2.83 per share a year ago and achieved adjusted EPS of $0.23 for the period, compared to $0.46 a year ago. In the fourth quarter of 2019, reported GAAP net income included a net income tax benefit of $4.102 billion or $2.90 per share related to an intra-entity asset transfer of intellectual property.

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For the full year 2020, the company generated net sales of $9.913 billion. This represents a decline of (7.7) percent on a reported basis, (7.8) percent on an operational1 basis and (11.3) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact associated with the WATCHMAN conversion. The company reported a GAAP net loss available to common stockholders of $(173) million or $(0.12) per share, compared to GAAP net income of $4.700 billion or $3.33 per share a year ago, and delivered full year adjusted EPS of $0.96, compared to $1.58 a year ago. Full year 2019 GAAP EPS included a net income tax benefit of $2.91 per share related to the intra-entity asset transfer of intellectual property discussed above.

"As we look to 2021 and beyond, we are well-positioned given the strength of our global team and our diversified portfolio," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I’m excited about our outlook for growth—from our category leadership positions to our innovative pipeline and commercial execution—and I am incredibly proud of how Boston Scientific delivered on our mission to transform lives amid the challenges of 2020."

Fourth quarter financial results and recent developments:

Reported GAAP net income available to common stockholders of $0.10 per share and adjusted EPS of $0.23 per share. Included in adjusted EPS is:
a ($0.06) impact associated with the WATCHMAN conversion mentioned above, which is now substantially complete, and
an ($0.07) impact related to the voluntary recall of the LOTUS Edge Aortic Valve System and discontinuation of the LOTUS platform
Generated the following sales growth/(declines) in each reportable segment4, compared to the prior year period:
MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic
Generated the following regional5 sales declines, compared to the prior year period:
U.S.: (9.2) percent reported and operational
EMEA (Europe, Middle East and Africa): (1.1) percent reported and (5.9) percent operational
APAC (Asia-Pacific): (1.1) percent reported and (5.6) percent operational
Emerging Markets3: (9.9) percent reported and (8.9) percent operational
Received U.S. Food and Drug Administration (FDA) approval for Vercise Genus family of Deep Brain Stimulation Systems, approved for MR conditional use in a magnetic resonance imaging (MRI) environment.
Received FDA approval for WaveWriter Alpha portfolio of Spinal Cord Stimulator Systems, offering expanded personalization based on patient needs to treat multiple areas of chronic pain.
Received FDA Breakthrough Device designation for the AGENT Drug-Coated Balloon (DCB),6 which is designed for percutaneous transluminal coronary angioplasty to treat coronary artery disease. Breakthrough Device designation provides patients more timely access to novel devices that may provide a substantial improvement over existing therapies.
Received FDA approval for the SYNERGY MEGATRON Bioabsorbable Polymer Stent7, the only stent platform that is purpose built for use in large proximal vessels with the ability to expand to 6.0 mm in diameter.
Received FDA approval for the Ranger Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease in the superficial femoral artery and proximal popliteal artery. Positive 24-month data from the COMPARE trial was also presented at the Leipzig Interventional Course (LINC) congress, demonstrating non-inferiority of the low-dose paclitaxel-coated Ranger DCB (2.0 µg/mm2) compared to the higher dose IN.PACT DCB (Medtronic) balloon (3.5 µg/mm2).
Received approval for the Eluvia Drug-Eluting Vascular Stent System from China’s Center for Medical Device Evaluation and initiated a full launch in the region.
Received FDA clearance for the ORISE ProKnife, a cutting tool designed for endoluminal surgeries for tissue removal and motility disorders of the gastrointestinal tract.
Received Japanese Pharmaceuticals and Medical Devices Agency approval and Japanese National Health Insurance reimbursement approval for the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device, with plans to launch later this year, and surpassed 150,000 cumulative WATCHMAN implants worldwide.
Announced the initiation of CHAMPION-AF—a randomized head-to-head trial to study the safety and efficacy of the next-generation WATCHMAN FLX device vs. non-vitamin K antagonist oral anticoagulants outcomes across a broad spectrum of patients with non-valvular atrial fibrillation, to evaluate the technology as a potential first-line therapy.
Received Class I designation for the EMBLEM Subcutaneous Implantable Defibrillator System in recently updated American Heart Association and American College of Cardiology guidelines on treating patients with hypertrophic cardiomyopathy.
Received approval from the FDA to begin the early feasibility study in the U.S. for the Millipede Transcatheter Annuloplasty Ring System8, which will assess the safety and feasibility of the system in patients with functional mitral regurgitation.
Announced a definitive agreement to acquire Preventice Solutions, Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, for a purchase price of $925 million, with up to an additional $300 million in a potential commercial milestone payment. Boston Scientific is currently an investor in Preventice and holds an equity stake of approximately 22 percent, which is expected to result in a net payment of approximately $720 million upon closing and a milestone payment of up to approximately $230 million.
Signed definitive agreement to divest BTG Specialty Pharmaceuticals business to Stark International Lux S.A.R.L. and SERB SAS, affiliates of SERB, for $800 million in cash.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth rates exclude the impact of foreign currency fluctuations and net sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable net sales. Organic net sales growth rates also exclude the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, as well as prior period net sales associated with our intrauterine health franchise, which we divested in Q2 2020.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition.

5. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals. In Q4 2020, we signed a definitive agreement to sell Specialty Pharmaceuticals. The sale is expected to close in the first half of 2021, pending customary closing conditions.

6. Agent is an investigational device. Limited by Federal law for investigational use only. Not available for sale.

7. Synergy Megatron indicated for use in coronary arteries 3.5mm to 5.0mm in diameter.

8. Millipede is an investigational device. Limited by Federal law for investigational use only. Not available for sale.

Guidance for First Quarter and Full Year 2021

The company estimates revenue growth for the first quarter of 2021, versus the prior year period, to be in a range of approximately 0 to 6 percent on a reported basis and a growth range of approximately (3) to 3 percent on an organic basis. First quarter organic guidance excludes the impact of foreign currency fluctuations and the divestiture of our intrauterine health franchise, which we divested in Q2 2020, and includes net sales of the Specialty Pharmaceuticals business, assuming the previously announced divestiture closes on April 1, 2021. First quarter guidance excludes the previously announced acquisition of Preventice Solutions, Inc. which is projected to close by mid-2021, subject to customary closing conditions. The company estimates earnings on a GAAP basis in a range of $0.05 to $0.11 per share and estimates adjusted earnings, excluding certain charges (credits) in a range of $0.28 to $0.34 per share.

The company estimates revenue growth for the full year 2021, versus the prior year period, to be in a range of approximately 13 to 19 percent on a reported basis and a growth range of approximately 12 to 18 percent on an organic basis. Full year organic guidance excludes the impact of foreign currency fluctuations and the divestiture of our intrauterine health franchise, which we divested in Q2 2020, and includes net sales of the Specialty Pharmaceuticals business through the first quarter of 2021 assuming the previously announced divestiture closes on April 1, 2021. Full year guidance excludes the previously announced acquisition of Preventice Solutions, Inc. which is projected to close by mid-2021, subject to customary closing conditions. The company estimates income on a GAAP basis in a range of $0.72 to $0.82 per share and estimates adjusted earnings, excluding certain charges (credits) in a range of $1.50 to $1.60 per share.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On February 3, 2021 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that it has commenced an underwritten public offering of $200.0 million of its common stock (Press release, Quanterix, FEB 3, 2021, View Source [SID1234574579]). In connection with the offering, Quanterix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price less the underwriting discounts and commissions. All of the shares in the offering will be sold by Quanterix. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, SVB Leerink LLC and Cowen and Company, LLC are acting as joint bookrunning managers for the offering. Canaccord Genuity LLC is acting as lead manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3ASR (File No. 333-249925) previously filed with the Securities and Exchange Commission ("SEC") on November 6, 2020, which automatically became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Goldman Sachs & Co. LLC, 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526 or by e-mail at [email protected], from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6105 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.