On February 3, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 743,495, common shares of the Company (the "Common Shares"), at a price to the public of $13.45 per Common Share, less underwriting discounts and commissions, for gross proceeds to the Company of approximately $10.0 million (Press release, ImmunoPrecise Antibodies, FEB 3, 2021, View Source [SID1234574566]). The closing of the offering is expected to occur on or about February 8, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as sole book-running manager for the Offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 111,524 Common Shares at the public offering price, less underwriting discounts and commissions. The Company intends to use the net proceeds from the Offering for (i) pursuing the Company’s objective of expanding its operations into Good Laboratory Practice and Good Manufacturing Practice-certified; (ii) the development and commercialization of Talem Therapeutics, LLC’s, a wholly owned subsidiary of the Company, internal and partnered therapeutic discovery programs; (iii) investments in employees, partnerships, cloud computing, data curation and analysis to enable further work toward the development of custom algorithms, cloud computing, large-scale sequence data analysis, and expanded access to next-generation sequencing technologies; (iv) the development of its PolyTopeTM approach to the development of innovative therapeutics and vaccines against the COVID-19; and (v) general corporate and working capital purposes.

In connection with the Offering, the Company filed with the securities regulatory authorities in each of the provinces of Canada (except Quebec), a short form base shelf prospectus dated December 11, 2020. The short form base shelf prospectus was filed on Form F-10 with the U.S. Securities and Exchange Commission (SEC). The Company will also file a preliminary prospectus supplement to the short form base shelf prospectus with the securities regulatory authority in the Province of British Columbia as well as with the SEC as part of a registration statement on Form F-10 under the U.S.-Canada multijurisdictional disclosure system (MJDS). The Common Shares will only be offered and sold in the United States either directly or through duly registered U.S. broker dealers. No Common Shares will be offered or sold to Canadian purchasers.

The Offering is being made in the United States only by means of the registration statement, including the base shelf prospectus and applicable prospectus supplement. Such documents contain important information about the offering. Copies of the short form base shelf prospectus and accompanying preliminary prospectus supplement will be filed with the SEC and will be available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Electronic copies of the preliminary prospectus supplement and registration statement, when available, may also be obtained from H.C. Wainwright & Co. LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

Prospective investors should read the base shelf prospectus and the prospectus supplement as well as the registration statement before making an investment decision.

No securities regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On February 3, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its fourth quarter and full year 2020 financial results on Wednesday, February 17, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, FEB 3, 2021, View Source [SID1234574565]).

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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)

To register for the conference call and webcast, please use one of the methods below. Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

Online registration: View Source
Phone registration: 833-508-4355 or 415-481-6010

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to ir.invitae.com.

On February 3, 2021 Biogen Inc. (Nasdaq: BIIB) reported fourth quarter and full year 2020 financial results (Press release, Biogen, FEB 3, 2021, View Source [SID1234574564]).
"In 2020 Biogen executed well and maintained leadership across our core businesses in multiple sclerosis (MS), spinal muscular atrophy (SMA), and biosimilars, while simultaneously making significant progress towards building a multi-franchise portfolio through both internal pipeline developments and multiple new strategic collaborations," said Michel Vounatsos, Biogen’s Chief Executive Officer.

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"Although we expect a financial reset in 2021 primarily due to the entry of TECFIDERA generics, we believe that 2021 has the potential to be a transformative year for our pipeline with an anticipated regulatory decision in the U.S. on aducanumab for Alzheimer’s disease in June as well as pivotal trial readouts in postpartum depression, major depressive disorder, ALS, and choroideremia," Vounatsos said. "I’m proud of all that we have achieved in a challenging year, while also accelerating our actions on health and climate as well as diversity and inclusion."
Fourth Quarter 2020 Financial Results
•Fourth quarter total revenues were $2,853 million, a 22% decrease versus the prior year at both actual and constant currency*.
◦MS revenues, including royalties on sales of OCREVUS, of $1,806 million decreased 24% versus the prior year at both actual and constant currency.
◦SPINRAZA revenues of $498 million decreased 8% versus the prior year at actual currency and decreased 10% at constant currency.
◦Biosimilars revenues of $197 million increased 1% versus the prior year at actual currency and decreased 4% at constant currency.
•Fourth quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $358 million and $2.32, respectively.
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•Fourth quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $706 million and $4.58, respectively.
Full Year 2020 Financial Results
•Full year total revenues were $13,445 million, a 6% decrease versus the prior year at both actual and constant currency*.
◦MS revenues, including royalties on sales of OCREVUS, of $8,678 million decreased 6% versus the prior year at actual currency and decreased 5% at constant currency.
◦SPINRAZA revenues of $2,052 million decreased 2% versus the prior year at actual currency and decreased 1% at constant currency.
◦Biosimilars revenues of $796 million increased 8% versus the prior year at actual currency and increased 6% at constant currency.
•Full year GAAP net income and diluted EPS attributable to Biogen Inc. were $4,001 million and $24.80, respectively.
•Full year Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $5,436 million and $33.70, respectively.
A reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release.
* Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.
Expense Highlights

•GAAP R&D expense in the fourth quarter of 2020 included a $1,084 million charge related to Biogen’s collaboration with Sage Therapeutics, Inc. (Sage), comprising an $875 million upfront payment and a $209 million premium paid on Sage common stock purchased. These amounts are excluded from Non-GAAP R&D expense.
•GAAP and Non-GAAP R&D expense in the fourth quarter of 2020 included a total of $68 million in upfront payments related to collaboration agreements with Scribe Therapeutics Inc., Atalanta Therapeutics (Atalanta), and ViGeneron GmbH (ViGeneron).
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•Fourth quarter 2020 GAAP amortization and impairment of acquired intangible assets was $249 million and included a $115 million impairment charge related to timrepigene emparvovec (BIIB111), which was obtained as part of our acquisition of Nightstar Therapeutics plc. During the fourth quarter of 2020 we began experiencing third-party manufacturing delays for BIIB111 and determined that forecasted costs associated with advancing the program through development and commercialization will exceed our original estimates. We also recognized a GAAP impairment charge of approximately $75 million during the fourth quarter of 2020 related to the discontinuation of BIIB054 (cinpanemab) in Parkinson’s disease based on data from the Phase 2 SPARK study, which did not meet its primary or secondary endpoints. Full year 2020 GAAP amortization and impairment of acquired intangible assets was $465 million. These amounts are excluded from Non-GAAP results.
•Fourth quarter 2020 GAAP gain on fair value remeasurement of contingent consideration was $63 million, including $51 million related to BIIB054. Full year 2020 GAAP gain on fair value remeasurement of contingent consideration was $86 million. These amounts are excluded from Non-GAAP results.
•Fourth quarter 2020 GAAP and Non-GAAP net expense related to collaboration profit sharing was $66 million. Full year 2020 GAAP and Non-GAAP net expense related to collaboration profit sharing was $233 million.
Other Financial Highlights
•Fourth quarter 2020 GAAP other income was $684 million, primarily driven by gains on strategic equity investments of $734 million partially offset by $52 million of net interest expense. Fourth quarter 2020 Non-GAAP other expense was $51 million, primarily driven by $52 million of net interest expense. Full year 2020 GAAP other income was $497 million, primarily driven by gains on strategic equity investments of $694 million partially offset by $181 million of net interest expense. Full year 2020 Non-GAAP other expense was $187 million, primarily driven by $171 million of net interest expense.
•Fourth quarter 2020 effective GAAP and Non-GAAP tax rates were 3.8% and 15.9%, respectively. Full year 2020 effective GAAP and Non-GAAP tax rates were 19.7% and 17.9%, respectively. The fourth quarter 2020 effective GAAP tax rate was impacted by the effective settlement of certain tax matters during the quarter.
•In the fourth quarter of 2020 Biogen repurchased approximately 1.6 million shares of the Company’s common stock for a total value of $400 million. Throughout 2020 Biogen repurchased approximately 22.4 million shares of the Company’s common stock for a total value of $6,679 million. As of December 31, 2020, there was $4,600 million remaining under the share repurchase program authorized in October 2020.
•For the fourth quarter of 2020 the Company’s weighted average diluted shares were 154 million. For 2020 the Company’s full year weighted average diluted shares were 161 million.
•Fourth quarter 2020 net cash outflow from operations was $367 million. Capital expenditures were $86 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was a net cash outflow of $453 million. Fourth quarter cash flow was negatively impacted by the upfront payments to Denali Therapeutics Inc. (Denali) and Sage and the equity premium paid to Sage.
•Full year 2020 net cash flow from operations was $4,230 million. Capital expenditures were $425 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was $3,805 million. Full year cash flow was negatively impacted by the upfront payments and equity premiums paid to Sangamo Therapeutics, Inc., Denali, and Sage.
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•As of December 31, 2020, Biogen had $7,426 million in total debt, and cash, cash equivalents, and marketable securities totaling $3,382 million, resulting in net debt of $4,044 million.
2021 Financial Guidance
Biogen expects full year 2021 revenue to be between $10.45 billion and $10.75 billion, Non-GAAP diluted EPS to be between $17.00 and $18.50, and capital expenditures to be between $375 million and $425 million.
This financial guidance assumes aducanumab, an investigational treatment for Alzheimer’s disease, will be approved in the U.S. by June 7, 2021, although uncertainty remains on the U.S. Food and Drug Administration’s (FDA) decision. If aducanumab is approved in the U.S., Biogen expects an immediate launch with only modest revenue in 2021, ramping thereafter. This financial guidance further assumes there will be a sharp decline of TECFIDERA in the U.S. during the first half of 2021. Biogen also expects that there will be significant erosion of RITUXAN in the U.S.
Non-GAAP R&D expense is expected to be between $2.35 billion and $2.45 billion, and Non-GAAP SG&A expense is expected to be between $2.6 billion and $2.7 billion. This Non-GAAP SG&A expense estimate includes approximately $600 million in support of the potential launch of aducanumab, approximately $200 million of which would be reimbursable by Eisai Co., Ltd. (Eisai) and reflected on the collaboration profit sharing line post-commercialization. The Non-GAAP tax rate for 2021 is expected to be between 16% and 17%.
In addition, this financial guidance assumes that we will utilize a portion of the remaining share repurchase authorization of $4.6 billion throughout 2021, and that foreign exchange rates as of December 31, 2020, will remain in effect for the year, net of hedging activities.
This financial guidance does not include any impact from potential acquisitions or large business development transactions, as both are hard to predict, or any impact of potential tax or healthcare reform.
Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2021 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.
Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; and the ultimate outcome of pending significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.
Recent Events
•In January 2021 the FDA extended the review period by three months for the Biologics License Application (BLA) for aducanumab. The updated Prescription Drug User Fee Act (PDUFA) action date is June 7, 2021. As part of the ongoing review, Biogen submitted a response to an information request by the FDA, including additional analyses and clinical data, which the FDA considered a Major Amendment to the application that will require additional time for review. Biogen is collaborating with Eisai on the development of aducanumab.
•In January 2021 Biogen announced that the FDA approved a new intramuscular (IM) injection route of administration for PLEGRIDY for the treatment of relapsing forms of MS. The new IM
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administration of PLEGRIDY provides the well-characterized efficacy and safety of the platform injectable along with the potential for reduced injection site reactions. This FDA approval follows approval by the European Commission in December 2020.
•In January 2021 Biogen announced a new virtual research study, in collaboration with Apple, to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for decline in cognitive health including mild cognitive impairment, an early indicator of certain forms of dementia such as Alzheimer’s disease.
•In January 2021 Biogen announced first patient treated in a global clinical study, RESPOND. The Phase 4 study will examine the clinical benefit and assess the safety of SPINRAZA in infants and children with SMA who still have unmet clinical needs following treatment with gene therapy Zolgensma (onasemnogene abeparvovec). RESPOND will be conducted at approximately 20 sites worldwide and aims to enroll up to 60 children with SMA.
•In the fourth quarter of 2020 Biogen entered into a global collaboration and licensing agreement with ViGeneron, a gene therapy company, to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. The companies will use ViGeneron’s proprietary vgAAV, novel engineered AAV capsids, to efficiently transduce retinal cells via intravitreal injections. ViGeneron will be eligible to receive milestone payments as well as tiered royalties on net commercial sales of products arising from the collaboration.
•In the fourth quarter of 2020 Biogen submitted a Japanese New Drug Application to the Ministry of Health, Labor and Welfare for aducanumab. The Japanese regulatory authority will review the application through the standard review process.
•In the fourth quarter of 2020 Biogen and Sage announced a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder, postpartum depression, and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders. Under the agreement, Biogen made an $875 million upfront payment and an equity investment of $650 million and may pay up to $1.6 billion in potential milestone payments as well as potential profit sharing and royalties.
•In the fourth quarter of 2020 Samsung Bioepis Co., Ltd. and Biogen announced that the FDA accepted for review the BLA for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are a leading cause of blindness in the U.S.
•In the fourth quarter of 2020 Biogen was ranked the number one biotechnology company on the Dow Jones Sustainability World Index (DJSI World Index) for the fifth time, more than any other biotechnology company. The DJSI World Index recognizes the top 10% of companies in the S&P Global Broad Market Index for performance on environmental, social, and governance issues, which S&P Global considers key to generating long-term stakeholder value.
•In the fourth quarter of 2020 the FDA held a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (the Advisory Committee) to review data supporting the BLA for aducanumab and to vote on questions presented at the meeting. A majority of the Advisory Committee members voted against each of the questions presented at the meeting. FDA advisory committees provide non-binding recommendations for consideration by the FDA.
•In the fourth quarter of 2020 Biogen entered into strategic collaboration with Atalanta, a biotechnology company pioneering new treatment options for neurodegenerative disease, to develop RNAi therapeutics for multiple CNS targets for neurodegenerative diseases, including Parkinson’s
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disease and Alzheimer’s disease. Atalanta will be eligible to receive development and milestone payments on these programs as well as potential royalty payments.

Conference Call and Webcast
The Company’s earnings conference call for the fourth quarter will be broadcast via the internet at 8:00 a.m. ET on February 3, 2021, and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least one month.

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 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.