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.

On February 3, 2021 AbbVie (NYSE: ABBV) reported that financial results for the fourth quarter and full year ended December 31, 2020 (Press release, AbbVie, FEB 3, 2021, View Source [SID1234574563]).

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"We successfully completed the transformative Allergan acquisition and delivered another year of strong results in 2020, despite the challenges presented by the global pandemic," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based on our broad portfolio of diversified growth assets and the robust momentum of our business, we expect impressive growth again in 2021."

Fourth-Quarter Results

Worldwide net revenues were $13.858 billion, an increase of 59.2 percent on a reported basis, or an increase of 6.8 percent on a comparable operational basis.
Global net revenues from the immunology portfolio were $5.958 billion, an increase of 15.3 percent on a reported basis, or 14.8 percent on an operational basis.
Global Humira net revenues of $5.152 billion increased 4.8 percent on a reported basis, or 4.4 percent on an operational basis. U.S. Humira net revenues were $4.293 billion, an increase of 8.2 percent. Internationally, Humira net revenues were $859 million, a decrease of 9.4 percent on a reported basis, or 11.4 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $525 million.
Global Rinvoq net revenues were $281 million.
Global net revenues from the hematologic oncology portfolio were $1.789 billion, an increase of 15.7 percent on a reported basis, or 15.5 percent on an operational basis.
Global Imbruvica net revenues were $1.424 billion, an increase of 9.8 percent, with U.S. net revenues of $1.165 billion and international profit sharing of $259 million.
Global Venclexta net revenues were $365 million, an increase of 46.2 percent on a reported basis, or 45.0 percent on an operational basis.
Global net revenues from the aesthetics portfolio were $1.142 billion, a decrease of 0.7 percent on a comparable operational basis.
Global Botox Cosmetic net revenues were $493 million, an increase of 9.1 percent on a comparable operational basis.
Global net revenues from the neuroscience portfolio were $1.389 billion, an increase of over 100.0 percent on a reported basis, or 14.9 percent on a comparable operational basis.
Global Botox Therapeutic net revenues were $567 million, a decrease of 1.0 percent on a comparable operational basis.
Global Vraylar net revenues were $401 million, an increase of 38.0 percent on a comparable operational basis.
Global Ubrelvy net revenues were $65 million.
On a GAAP basis, the gross margin ratio in the fourth quarter was 66.2 percent. The adjusted gross margin ratio was 81.8 percent.
On a GAAP basis, selling, general and administrative expense was 23.3 percent of net revenues. The adjusted SG&A expense was 22.3 percent of net revenues.
On a GAAP basis, research and development expense was 13.6 percent of net revenues. The adjusted R&D expense was 12.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the fourth quarter was 27.1 percent. The adjusted operating margin was 46.9 percent.
On a GAAP basis, net interest expense was $618 million.
On a GAAP basis, the tax rate in the quarter was 102.5 percent. The adjusted tax rate was 11.6 percent.
Diluted EPS in the fourth quarter was $0.01 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.92.
Recorded a $4.7 billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates.
Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). Rinvoq is the first oral, once-daily, selective and reversible JAK inhibitor approved for three adult rheumatic indications in the European Union: rheumatoid arthritis (RA), PsA and AS. The EC approval is supported by data from three pivotal clinical studies in PsA and AS where Rinvoq met all primary and key secondary endpoints with a safety profile consistent with that seen in RA.
AbbVie announced top-line results from the Phase 3b Heads Up study showing that Rinvoq (30 mg, once daily) achieved superiority to Dupixent (dupilumab, 300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis (AD). Rinvoq also showed superiority versus Dupixent for all ranked secondary endpoints, including early improvements in itch and skin clearance. The safety profile of Rinvoq was consistent with previous AD studies, with no new safety risks observed. Full results from the Heads Up study will be submitted for publication in a peer-reviewed journal.
AbbVie announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed Rinvoq (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8 in adult patients with moderate to severe ulcerative colitis (UC). Additionally, all ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met. The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe UC and full results from the study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
AbbVie announced positive top-line results from the Phase 3 ADVANCE and MOTIVATE studies, which evaluated the efficacy and safety of Skyrizi (risankizumab) for induction therapy in adult patients with moderate to severe Crohn’s disease (CD). In ADVANCE and MOTIVATE, both doses of Skyrizi (600mg and 1200mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12, demonstrating superiority versus placebo. Additionally, key secondary endpoints showed significant clinical and endoscopic outcomes, with symptom improvement observed as early as week 4. The overall safety results in these studies were generally consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced positive top-line results from the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies evaluating Skyrizi (150 mg) in adults with active PsA, with Skyrizi demonstrating strong levels of response on both joint and skin endpoints. In both Phase 3 trials, significantly more patients treated with Skyrizi achieved the primary endpoint of ACR20 response at week 24 versus placebo. Results of ranked secondary endpoints showed significant improvements in skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index (PASI 90)), physical function (as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)) and minimal disease activity (MDA) at week 24. The safety results in these studies to-date were generally consistent with the known profile of Skyrizi in psoriasis (PsO) patients. Detailed data from both pivotal studies will be presented at an upcoming medical meeting and we expect to submit our regulatory applications for Skyrizi in PsA in the first half of this year.
AbbVie hosted an Immunology Strategic Update event on December 14, 2020 for members of the investment community. The event highlighted AbbVie’s immunology leadership, market expectations, strong and growing body of clinical data, innovative pipeline, and strategy to capitalize on a best-in-class immunology portfolio over the long term. As part of the event, AbbVie raised its 2025 risk-adjusted combined sales guidance for Skyrizi and Rinvoq to greater than $15 billion, above previous guidance of greater than $10 billion. Supporting materials from the Immunology Strategic Update, including the event presentation and an archived webcast, can be found on AbbVie’s Investor Relations website at investors.abbvie.com.
At the virtual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper), AbbVie presented data from nearly 40 abstracts on 8 investigational and approved products across 11 cancer types, including 10 oral presentations. Key data presentations included new disease-free survival data from the Phase 2 CAPTIVATE study evaluating Imbruvica (ibrutinib) plus Venclexta (venetoclax) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); new extended follow-up data for fixed duration treatment Venclexta in CLL from the Phase 3 Murano and Phase 3 CLL14 studies; results from several long-term follow-up studies evaluating Imbruvica in multiple types of blood cancers; and data from collaborations on pipeline candidates in partnership with Genmab and I-Mab. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). The update is based on more than 5 years of Phase 3 iNNOVATE final analysis data, which demonstrated Imbruvica plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM. Imbruvica was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018 based on the iNNOVATE primary analysis.
Allergan Aesthetics announced the launch of CoolSculpting Elite, its next generation fat reduction system with new technology that allows for the treatment of two areas of fat at once and new elite applicators designed for improved fit and comfort. CoolSculpting Elite harnesses proven CoolSculpting technology to target, freeze, and eliminate treated fat cells. CoolSculpting Elite is FDA cleared to treat visible fat bulges in nine areas of the body including the thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), upper arm, and the submental and submandibular areas.
Allergan Aesthetics entered into a warrant agreement with Cypris Medical, a privately held medical device company, that provides Allergan Aesthetics the right to acquire Cypris Medical, including the company’s Xact device, following the completion of a clinical trial to be initiated in 2021. The Xact device is a minimally-invasive alternative option for performing face and neck lifts and the planned clinical trial will evaluate the safety and effectiveness of Xact in treating midface descent as well as for neck lifts.
AbbVie presented results from 16 neurotoxin research abstracts across multiple therapeutic and cosmetic indications at the TOXINS 2021 Virtual Conference. The presentations included new analyses from the CD-PROBE study evaluating sustained efficacy and tolerability of Botox (onabotulinumtoxinA) in patients with cervical dystonia, new analyses from the ASPIRE study on patient adherence to Botox for management of spasticity, data on Botox treatment in adult patients with overactive bladder and in pediatric patients with neurogenic detrusor overactivity, a meta-analysis of immunogenicity rates across 10 therapeutic and aesthetic indications and results from a clinical trial evaluating the safety and pharmacodynamic response with higher doses of Botox on clinician and patient reported outcomes in patients with moderate to severe glabellar lines.
At the virtual American Academy of Ophthalmology (AAO) 2020, AbbVie presented new Phase 2 efficacy data for an investigational treatment of presbyopia, new data evaluating the effectiveness of Durysta (bimatoprost implant) and additional analysis of data from Phase 3 ARTEMIS studies that shed light on how glaucoma patients with different characteristics may respond to Durysta.
AbbVie recently provided new long-term sales guidance. The company expects continued strong total company sales growth leading up to the U.S. Humira (adalimumab) loss of exclusivity (LOE) in 2023. AbbVie expects total company sales to decline in 2023, following the LOE, with modest top-line growth expected in 2024. The company expects a rapid return to strong top-line growth in 2025, with a high-single digit compound annual growth rate (CAGR) through the remainder of the decade. AbbVie also outlined expectations for high-single digit annual growth for its aesthetics portfolio over the next decade, peak Vraylar (cariprazine) sales approaching $4 billion in current approved indications, peak Ubrelvy (ubrogepant) sales of greater than $1 billion and peak atogepant sales of greater than $1 billion. The company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and Skyrizi global sales in 2025.
AbbVie and Frontier Medicines, Corp., a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets. Under the multi-year collaboration, AbbVie and Frontier will utilize Frontier’s proprietary chemoproteomics platform to identify small molecules for programs directed to novel E3 ligases and certain oncology and immunology targets.
AbbVie announced that it will collaborate with 6 nonprofit partners as part of its $50 million investment to support health and education opportunity in underserved Black communities across the U.S. The partners include Direct Relief, University of Chicago Medicine’s Urban Health Initiative, National Urban League, Year Up, United Negro College Fund (UNCF) and Providence St. Mel School. Additionally, as part of the announcement, AbbVie expanded its employee matching program to 3:1 for donations to civil rights nonprofits fostering racial equity.
Full-Year 2021 Outlook

AbbVie is issuing its GAAP diluted EPS guidance for the full-year 2021 of $6.69 to $6.89. AbbVie expects to deliver adjusted diluted EPS for the full-year 2021 of $12.32 to $12.52. The company’s 2021 adjusted diluted EPS guidance excludes $5.63 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our fourth-quarter performance. The call will be webcast through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.

Non-GAAP Financial Results

Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie’s management believes non-GAAP financial measures provide useful information to investors regarding AbbVie’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company’s 2021 financial guidance is also being provided on both a reported and a non-GAAP basis.

On February 3, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States (Press release, InnoCare Pharma, FEB 3, 2021, View Source [SID1234574580]).

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ICP-192 is a highly selective small-molecule pan-FGFR inhibitor for the treatment of various solid tumors with FGFR aberrations. Currently it is in Phase I/II clinical studies in China and the United States.

The Phase II trial in China is a multi-center, open-label clinical trial designed to evaluate the safety and efficacy of ICP-192 in patients with advanced cholangiocarcinoma and urothelial cancer that have FGFR aberrations. The phase II clinical trials have enrolled nearly 20 patients, and cases of partial response and complete response have been observed in patients of FGFR gene alterations.

"We will continue to advance ICP-192 in clinical studies for the treatment of advanced solid tumors with FGFR aberrations in China and global," said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. "ICP-192 is an excellent drug candidate for the treatment of solid tumors with FGFR aberrations. We will work together with top clinical experts to rapidly advance the trials to explore the potential usage of ICP-192 in a variety of solid tumors. We hope to provide patients with better treatment options."

ICP-192 is the second innovative drug candidate discovered by InnoCare, which was approved for the initiation of clinical trials in the U.S.