On April 29, 2022 Avecho (ASX:AVE) reported its Quarterly Activities Report and 4C Quarterly Cash Flow Report, for the period ended 31 March 2022 (Press release, Phosphagenics, APR 29, 2022, View Source [SID1234613211]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key highlights from this period include:

Completion of Phase II Clinical Trial examining its proprietary topical cannabidiol (CBD) gel for the management of pain associated with arthritis of the hand;
First licensing and supply agreement for the use of TPM in the US recreational cannabis space;
TGA feedback on Phase III CBD soft-gel program and completion of initial Phase III Clinical Trial design;
Avecho’s cash balance on 31 March was $3.265m.

Throughout the Quarter, the Company has remained heavily focused on advancing its CBD soft-gel product, whilst also pursuing large, untapped licensing opportunities in the US cannabis space.

Avecho CEO, Dr Paul Gavin, said:

"The data we have generated across our expanded cannabinoid program is beginning to pay dividends. Our deep biotechnology expertise and experience in non-cannabinoid drug development is seen as a major differentiator to medicinal cannabis companies for potential licensees. We are focused on expanding our business development activities with the aim of closing further deals in the various cannabinoid markets"

On April 29, 2022 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2022 (Press release, AbbVie, APR 29, 2022, View Source [SID1234613210]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This year is off to a strong start. Our first quarter results highlight the diversity of our portfolio and include compelling performance from key growth drivers Skyrizi, Rinvoq, Aesthetics and Neuroscience," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our momentum combined with ramping contributions from new products and new indications will drive accelerating revenue and EPS growth through the rest of the year."

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures.

First-Quarter Results

Worldwide net revenues were $13.538 billion, an increase of 4.1 percent on a GAAP basis, or 5.4 percent on an operational basis.

Global net revenues from the immunology portfolio were $6.141 billion, an increase of 6.9 percent on a reported basis, or 8.1 percent on an operational basis.
Global Humira net revenues of $4.736 billion decreased 2.7 percent on a reported basis, or 1.8 percent on an operational basis. U.S. Humira net revenues were $3.993 billion, an increase of 2.2 percent. Internationally, Humira net revenues were $743 million, a decrease of 22.6 percent on a reported basis, or 17.9 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $940 million, an increase of 63.7 percent on a reported basis, or 65.6 percent on an operational basis.
Global Rinvoq net revenues were $465 million, an increase of 53.6 percent on a reported basis, or 57.3 percent on an operational basis.
Global net revenues from the hematologic oncology portfolio were $1.646 billion, a decrease of 1.6 percent on a reported basis, or 0.6 percent on an operational basis.
Global Imbruvica net revenues were $1.173 billion, a decrease of 7.4 percent, with U.S. net revenues of $874 million and international profit sharing of $299 million.
Global Venclexta net revenues were $473 million, an increase of 16.9 percent on a reported basis, or 21.1 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.488 billion, an increase of 19.2 percent on a reported basis, or 20.4 percent on an operational basis.
Global Botox Therapeutic net revenues were $614 million, an increase of 15.4 percent on a reported basis, or 16.6 percent on an operational basis.
Vraylar net revenues were $427 million, an increase of 23.4 percent.
Global Ubrelvy net revenues were $138 million.
Global net revenues from the aesthetics portfolio were $1.374 billion, an increase of 20.5 percent on a reported basis, or 22.5 percent on an operational basis.
Global Botox Cosmetic net revenues were $641 million, an increase of 34.4 percent on a reported basis, or 36.6 percent on an operational basis.
Global Juvederm net revenues were $410 million, an increase of 27.5 percent on a reported basis, or 30.9 percent on an operational basis.
On a GAAP basis, the gross margin ratio in the first quarter was 70.1 percent. The adjusted gross margin ratio was 84.5 percent.
On a GAAP basis, selling, general and administrative expense was 23.1 percent of net revenues. The adjusted SG&A expense was 21.1 percent of net revenues.
On a GAAP basis, research and development expense was 11.1 percent of net revenues. The adjusted R&D expense was 10.9 percent of net revenues.
Acquired IPR&D and milestones expense was 1.1 percent of net revenues.
On a GAAP basis, the operating margin in the first quarter was 34.8 percent. The adjusted operating margin was 51.4 percent, which includes an unfavorable 110 basis point impact from acquired IPR&D and milestones expense.
Net interest expense was $539 million.
On a GAAP basis, the tax rate in the quarter was 8.8 percent. The adjusted tax rate was 12.1 percent.
Diluted EPS in the first quarter was $2.51 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.16. These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib, 45 mg (induction dose) and 15 mg and 30 mg (maintenance dose)) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by data from two Phase 3 induction studies and one maintenance study. In these studies, significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo. The safety of Rinvoq, including the 45 mg dose as induction therapy, in these studies was generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed. This approval marks the first indication for Rinvoq in gastroenterology and represents Rinvoq’s fourth FDA approved indication.
AbbVie announced positive top-line results from the Phase 3 induction study U-EXCEL, which showed Rinvoq (45 mg, once daily) achieved both primary endpoints of clinical remission and endoscopic response, compared to placebo at week 12, as well as most key secondary endpoints in patients with moderate to severe Crohn’s disease (CD). The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. U-EXCEL is the second of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe CD and full results will be presented at upcoming medical conferences and published in a peer-reviewed journal. Positive top-line results from the Phase 3 portion of the first induction study, U-EXCEED, were announced in December 2021 and the maintenance study for both clinical trials is ongoing.
AbbVie announced that the FDA extended the review period for Skyrizi (risankizumab) for the treatment of moderate to severe CD by three months to review additional data submitted by AbbVie, including information about the on-body injector. Currently approved indications for Skyrizi were not affected by this extension. Skyrizi is a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced that it resolved all U.S. Humira (adalimumab) litigation with Alvotech. Under the terms of the resolution, AbbVie will grant Alvotech a non-exclusive license to its Humira-related patents in the U.S., which will begin on July 1, 2023. AbbVie will make no payments of any form to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its Humira patents and acknowledges the validity and enforceability of the licensed patents. The resolution included dismissal of the patent and trade secret litigation between AbbVie and Alvotech.
At the Congress of European Crohn’s and Colitis Organization (ECCO), AbbVie shared 26 abstracts, including 16 oral and digital oral presentations, that reinforced AbbVie’s commitment to research that helps advance standards of care for inflammatory bowel disease (IBD) patients. Highlights included new post-hoc analyses from the pivotal Phase 3 Skyrizi program in CD as well as results from a post-hoc analysis of Phase 3 Rinvoq pivotal trials evaluating UC symptoms.
At the American Academy of Dermatology (AAD) Annual Meeting, AbbVie and Allergan Aesthetics presented new research that demonstrated their shared commitment to advancing science across a spectrum of dermatologic conditions and aesthetic indications. The research included new data on the efficacy, durability and safety of Rinvoq and Skyrizi as well as data from across the Allergan Aesthetics portfolio.
AbbVie and Genmab announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy. Results from this cohort demonstrated a confirmed overall response rate (ORR) of 63.1 percent with a 12-month median duration of response. Based on the topline results, the companies will engage global regulatory authorities and data from the clinical trial will be presented at a future medical meeting. Epcoritamab is being co-developed by AbbVie and Genmab.
At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, AbbVie presented positive results from a Phase 2 trial evaluating navitoclax in combination with ruxolitinib in patients with myelofibrosis that previously had a suboptimal response or disease progression with ruxolitinib monotherapy. The study evaluated 34 patients and median overall survival was not reached for patients who had a ≥ 1 grade improvement in bone marrow fibrosis (BMF) or ≥ 20% variant allele frequency (VAF) reduction. Additionally, at the time of analysis with > 2 year follow up, the survival estimate was 100% in patients who had improvements in BMF or VAF.
AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the FDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder (MDD). The submission is based on clinical trial results that showed clinically and statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in patients with MDD treated with Vraylar and an antidepressant. If approved, this milestone will be the fourth indication for Vraylar joining approvals for the treatment of adults with schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of depressive episodes associated with bipolar I disorder. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.
AbbVie announced that the Phase 3 PROGRESS trial evaluating Qulipta (atogepant), an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the preventive treatment of chronic migraine in adults, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo, for both the 60 mg once daily (QD) and 30 mg twice daily (BID) doses, across the 12-week treatment period. The study also demonstrated statistically significant improvement in all secondary endpoints and the overall safety profile of Qulipta was consistent with safety findings observed in previous studies with an episodic migraine population. Data from this study will support a submission to expand the use of Qulipta to include preventive treatment of chronic migraine in the U.S. and additional submissions globally.
At the American Academy of Neurology (AAN) Annual Meeting, AbbVie shared 30 abstracts demonstrating the breadth of its neuroscience portfolio. The abstracts highlighted AbbVie’s continued migraine treatment research across the spectrum of the disease, AbbVie’s commitment to patients with advanced Parkinson’s disease and new studies in spasticity and cervical dystonia.
AbbVie and Gedeon Richter Plc. (Richter) announced a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collaboration is based on the results of preclinical research carried out by Richter and includes several new chemical entities selected for development. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as Vraylar.
AbbVie announced the successful completion of its acquisition of Syndesi Therapeutics SA. The acquisition gives AbbVie access to Syndesi’s portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118, which is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and MDD.
Allergan Aesthetics announced that the FDA approved Juvederm Volbella XC for improvement of infraorbital (undereye) hollows in adults over the age of 21. With this approval, Juvederm Volbella XC became the first and only dermal filler to receive FDA approval for the improvement of infraorbital hollows.
At the Aesthetic and Anti-aging Medicine World Congress (AMWC), Allergan Aesthetics presented research that demonstrated its commitment to the future of aesthetics with a forward-facing trends report. The meeting also marked Allergan Aesthetics’ entry into the emerging category of Hybrid Injectables with the launch of HArmonyCa with lidocaine across Europe. The dual-effect Hybrid Injectable contains two active ingredients, hyaluronic acid, a well-known ingredient found in facial fillers, and calcium hydroxyapatite (CaHA), which is known to help stimulate collagen production.
AbbVie announced positive results from the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with age-related blurry near vision (presbyopia). Additional details of this trial will be presented at future medical congresses and will serve as the basis for a sNDA submission for an optional twice-daily administration to the FDA in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, Vuity is the first and only eye drop to treat age-related blurry near vision in adults.
At the American Glaucoma Society (AGS) Annual Meeting and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, AbbVie presented data from its leading portfolio of eye care treatments. Highlights included updated analyses that help further scientific understanding of Durysta (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients; new data on the Xen Gel Stent, a surgical implant designed to lower high eye pressure approved for refractory glaucoma patients; and new data on Vuity 1.25%.
AbbVie and Scripps Research, an independent, non-profit biomedical research and drug discovery institute, announced a global collaboration to develop potential novel, direct-acting antiviral treatments for COVID-19.
Full-Year 2022 Outlook

AbbVie is updating its adjusted diluted EPS guidance range for the full-year 2022 from $14.00 – $14.20 to $13.92 – $14.12 which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2022. The company’s 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2022, as both cannot be reliably forecasted.

On April 29, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer, reported the appointment of Robert H. Arch, Ph.D., as President and Chief Executive Officer (Press release, OncoSec Medical, APR 29, 2022, View Source [SID1234613209]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Arch was previously Head of Research at Elpiscience Biopharma, Ltd. from October 2019 to June 2021, and Head of the Liver Disease Department at China Novartis Institutes for BioMedical Research from February 2017 to October 2019. Robert’s leadership roles have been focused on shaping strong teams and building diversified R&D pipelines with innovative assets, from ideas to late-stage clinical development programs. His career over 28 years extends from academia to the pharmaceutical industry, including positions at Novartis, Takeda, GlaxoSmithKline, and Pfizer. Robert’s expertise in basic research and drug development includes chronic liver disease, cancer, immuno-oncology, respiratory disease, and inflammatory disorders.

"On behalf of the Board of Directors, we are excited to welcome Robert to OncoSec and confident he will bring a focus on long-term value creation," remarked Kevin Smith, Board member of OncoSec. "Robert is uniquely qualified based on his executive experience in leading cross-functional pipeline strategy, and building and leading discovery teams across multiple geographic regions throughout his career."

"I am grateful for the opportunity to join OncoSec and excited to advance TAVO and the intratumoral platform technology," said Dr. Robert Arch. "I am honored to lead our team in our mission to bring truly novel immunotherapies to patients."

Dr. Arch earned his Ph.D. in Germany at the University of Wuerzburg and the German Cancer Research Center (DKFZ), Heidelberg. After postdoctoral training at the DKFZ and the University of Chicago, he started his independent career as a faculty member in the Departments of Medicine and Pathology & Immunology at Washington University in Saint Louis. Robert is an author on more than 40 publications and book chapters, and he is co-inventor on several patents for clinical-stage assets.

Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

In connection with the hiring of Dr. Arch, the Compensation Committee of OncoSec’s Board of Directors granted to Dr. Arch non-qualified stock options to purchase 700,000 shares of OncoSec common stock as an inducement material to Dr. Arch entering into employment with OncoSec in accordance with Nasdaq Listing Rule 5635(c)(4), which grant shall be made outside of OncoSec’s 2011 Stock Incentive Plan. The stock options have an exercise price equal to the closing price of OncoSec’s common stock on May 2, 2022, and will vest quarterly commencing on the first completed calendar quarter after the date of grant, subject to the terms of grant. The vesting of shares of common stock underlying the non-qualified stock options are subject to Dr. Arch’s continuous service with OncoSec through each such vesting date.

On April 29, 2022 Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the presentation of two poster abstracts at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, to be held in-person on June 3-7, 2022 in Chicago, Illinois (Press release, Aravive, APR 29, 2022, View Source [SID1234613208]). Notably, abstract number 4511 was selected for an oral presentation as part of a Poster Discussion Session.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Abstract Title: A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib in patients with advanced or metastatic clear cell renal cell (ccRCC) carcinoma who have received front-line treatment (NCT04300140)
Abstract Number: 4511 (Poster Discussion Session – Data will be presented)
Poster Session: Genitourinary Cancer—Kidney and Bladder
Session Date: Saturday, June 4, 2022, 4:30 PM-6:00 PM; 1:15 PM-4:15 PM CDT

Abstract Title: A Phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib, cabozantinib and nivolumab, and as monotherapy in patients with advanced or metastatic clear cell renal cell carcinoma (NCT04300140)
Abstract Number: TPS4599 (Trials in Progress poster – No data presented)
Poster Session: Genitourinary Cancer—Kidney and Bladder
Session Date: Saturday, June 4, 2022, 1:15 PM-4:15 PM CDT

Both posters will be available here: View Source under the "Publications" section when the ASCO (Free ASCO Whitepaper) embargo is released on May 26, 2022 at 4:00 PM CDT.

On April 29, 2022 Bristol Myers Squibb (NYSE:BMY) reported that results for the first quarter of 2022, which reflect robust in-line product growth, increased adoption of new product portfolio and strong commercial execution (Press release, Bristol-Myers Squibb, APR 29, 2022, View Source [SID1234613207]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to execute against our strategic priorities, deliver solid revenue and earnings growth and advance our product pipeline," said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "Thanks to our team’s hard work and dedication, we achieved regulatory approvals of Opdualag and Camzyos, our new first-in-class medicines for patients living with metastatic melanoma and symptomatic obstructive hypertrophic cardiomyopathy, respectively. These milestone achievements, combined with our promising product pipeline and strong financial flexibility, provide a solid foundation that will enable us to deliver sustained growth and long-term benefits for our patients."

1 Acquired IPRD refers to certain in-process research and development ("Acquired IPRD") charges resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights.

First Quarter

$ amounts in millions, except per share amounts

* In the first quarter of 2022, GAAP and non-GAAP earnings per share include a net impact of ($0.10) per share due to Acquired IPRD charges that were partially offset by licensing income

FIRST QUARTER FINANCIAL RESULTS

All comparisons are made versus the same period in 2021 unless otherwise stated.

Bristol Myers Squibb posted first quarter revenues of $11.6 billion, an increase of 5%, driven by in-line products (primarily Eliquis and Opdivo) and new product portfolio (primarily cell therapy products and Reblozyl), partially offset by Recent LOE Products (Revlimid and Abraxane) and foreign exchange impacts.
U.S. revenues increased 10% to $7.7 billion in the quarter. International revenues decreased 3% to $4.0 billion in the quarter. When adjusted for foreign exchange impact, international revenues increased 3%, driven by in-line products (primarily Eliquis and Opdivo).
Gross margin increased from 74.3% to 78.8% in the quarter primarily due to an impairment charge related to marketed product rights in the same period of last year and foreign exchange. On a non-GAAP basis, gross margin increased from 78.1% to 79.2% in the quarter primarily driven by foreign exchange.
Marketing, selling and administrative expenses increased 10% to $1.8 billion in the quarter on a GAAP and non-GAAP basis primarily due to differences of timing of spend compared to the prior year as well as investments in our product portfolio.
Research and development expenses increased 2% to $2.3 billion in the quarter primarily due to an in-process research and development ("IPRD") impairment charge, partially offset by timing of spend. On a non-GAAP basis, research and development expenses decreased 4% to $2.1 billion in the quarter primarily due to timing of spend compared to the prior year.
Acquired IPRD increased to $333 million in the quarter primarily due to up-front and milestone charges relating to the Dragonfly and Immatics licensing arrangements.
Amortization of acquired intangible assets decreased 4% to $2.4 billion in the quarter primarily due to a longer than previously expected market exclusivity period for Pomalyst.
The GAAP effective tax rate changed from 19.8% to 23.9% in the quarter primarily due to the non-taxable contingent value rights related income in the prior period. The non-GAAP effective tax rate changed from 16.8% to 15.9% in the quarter primarily due to jurisdictional earnings mix.
The company reported net earnings attributable to Bristol Myers Squibb of $1.3 billion, or $0.59 per share, in the first quarter, compared to $2.0 billion, or $0.89 per share, for the same period a year ago. In addition to the items discussed above, the results include the impact of fair value adjustments on equity investments and contingent value rights in both periods.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.2 billion, or $1.96 per share, in the first quarter, compared to non-GAAP net earnings of $4.0 billion, or $1.74 per share, for the same period a year ago. In addition to the items discussed above, the results in the current period included the impact of lower weighted-average common shares outstanding.
Beginning with the first quarter of 2022, significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights are no longer excluded from non-GAAP results. These R&D charges that were previously specified are now presented in a new financial statement line item labeled Acquired IPRD. In the first quarter of 2022, GAAP and non-GAAP earnings per share include a net impact of ($0.10) per share due to Acquired IPRD charges that were partially offset by licensing income. For purposes of comparability, the non-GAAP financial results for the first quarter of 2021 have been updated to reflect this change. A discussion of the non-GAAP financial measures is included under the "Use of Non-GAAP Financial Information" section.

FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS

* In excess of +100%
** Includes products that have lost exclusivity in major markets, over-the-counter (OTC) products, royalty revenue and other mature products.

REVENUE HIGHLIGHTS

In-Line Products

Revenues for in-line products in the first quarter were $8.3 billion compared to $7.7 billion in the prior year period, representing an increase of 8%. In-line products revenue was largely driven by:

Eliquis revenues, which grew 11% compared to the prior year period. U.S. revenues were $2.1 billion compared to $1.9 billion in the prior year period, representing an increase of 12% driven by higher volume. International revenues were $1.1 billion compared to $963 million in the prior year period, representing an increase of 10% driven by higher demand, partially offset by foreign exchange.
Opdivo revenues increased 12% compared to the prior year period. U.S. revenues were $1.1 billion compared to $944 million in the prior year period, representing an increase of 16% driven by higher demand across multiple indications including the Opdivo+Yervoy based combinations for non-small cell lung cancer (NSCLC), Opdivo+Cabometyx combination for kidney cancer, and Opdivo-based therapies for various gastric and esophageal cancers, partially offset by declining second-line eligibility across tumor and increased competition. International revenues were $824 million compared to $776 million, representing an increase of 6% driven by higher demand as a result of launches for additional indications and core indications, partially offset by foreign exchange.
New Product Portfolio

New product portfolio revenues grew to $350 million compared to $161 million to the prior year period, driven by higher demand primarily relating to Abecma, Breyanzi and Reblozyl.

Recent LOE Products

Revlimid revenues declined by 5% compared to the prior year period. U.S. revenues increased 4% to $2.0 billion as compared to the prior year period driven by higher volume. International revenues were $759 million compared to $986 million in the prior year period, representing a decrease of 23% driven by generic erosion across several EU countries and Canada and foreign exchange.
Abraxane revenues declined 32% compared to the prior year period. U.S. revenues were $173 million compared to $225 million in the prior year period, representing a 23% decline driven by lower demand, primarily due to manufacturing delays.
PRODUCT AND PIPELINE UPDATE

Cardiovascular

Category

Asset

Milestone

Regulatory

CamzyosTM

The U.S. Food & Drug Administration (FDA) approved CamzyosTM (mavacamten) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM. The approval was based on the Phase 3 EXPLORER-HCM trial.

Clinical & Research

Camzyos

Interim results from the EXPLORER-LTE cohort of the MAVA-LTE trial showed sustained improvements in cardiovascular outcomes at 48 and 84 weeks among patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who were treated with Camzyos.

Results from the Phase 3 VALOR-HCM trial showed that the study met its primary and secondary endpoints, significantly reducing the need for septal reduction therapy (SRT) in patients with severely symptomatic oHCM who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association Guidelines at baseline, after 16 weeks of treatment with Camzyos.

Oncology

Category

Asset

Milestone

Regulatory

Opdivo (nivolumab)

The European Commission (EC) approved Opdivo in combination with Yervoy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥ 1%. The EC also approved Opdivo in combination with fluoropyrimidine and platinum-based chemotherapy for the same indication. The approvals were based on data from the Phase 3 CheckMate -648 trial.

The EC approved Opdivo for the adjuvant treatment of adults with high-risk muscle-invasive urothelial carcinoma with PD-L1 expression ≥1%, based on the Phase 3 CheckMate -274 trial. Opdivo is the first immunotherapy approved for these patients.

The FDA approved Opdivo 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy for the treatment of certain patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting, based on the Phase 3 CheckMate -816 trial. This marks the first immunotherapy-based treatment approved in this setting. An application for this indication was also validated by the European Medicines Agency.

OpdualagTM

(nivolumab and relatlimab-rmbw)

The FDA approved Opdualag, a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, a novel LAG-3 inhibitor, for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma, based on the Phase 2/3 RELATIVITY-047 trial.

Clinical & Research

Opdivo

Results from the Phase 3 CheckMate -816 trial showed that neoadjuvant treatment with Opdivo in combination with chemotherapy significantly improved event-free survival compared to chemotherapy alone in patients with resectable NSCLC.

Two-year follow-up results from the Phase 3 CheckMate -9ER trial demonstrated sustained survival, response rate benefits and health-related quality of life improvements with Opdivo combined with cabozantinib versus sunitinib in the first-line treatment of advanced renal cell carcinoma.

bempegaldesleu-kin

Phase 3 PIVOT IO-001 trial did not meet its primary endpoints of progression-free survival and objective response rate in patients with previously untreated unresectable or metastatic melanoma who were treated with bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy. The trial was conducted in collaboration with Nektar Therapeutics (NASDAQ: NKTR).

Based upon subsequent results from pre-planned analyses of two late-stage clinical studies in renal cell carcinomaand bladder cancer, coupled with the results of the PIVOT IO-001 trial in metastatic melanoma, BMS and Nektar have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo.

Hematology

Category

Asset

Milestone

Regulatory

Breyanzi

(lisocabtagene maraleucel)

The EC approved Breyanzi for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after two or more lines of systemic therapy. The approval is based on results from the TRANSCEND WORLD and TRANSCEND NHL 001 trials.

The FDA accepted for priority review the supplemental Biologics License Application (sBLA) to expand its current indication to include earlier use of Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after failure of first-line therapy. The FDA assigned a PDUFA goal date of June 24, 2022. The sBLA is based on results from the Phase 3 TRANSFORM trial.

Reblozyl

(luspatercept-aamt)

The FDA extended the review of the sBLA for Reblozyl for the treatment of anemia in adults with non-transfusion-dependent beta thalassemia to June 27, 2022. The sBLA is based on results from the Phase 2 BEYOND trial.

Immunology

Category

Asset

Milestone

Clinical & Research

Zeposia (ozanimod)

Interim results from the Phase 3 True North open-label extension trial demonstrated that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142 for patients with moderately to severely active ulcerative colitis who were treated with Zeposia.

Capital Allocation

The company continues to maintain a consistent, balanced approach to capital allocation focused on prioritizing investments for growth through business development along with reducing debt, commitment to dividend growth and share repurchase.

The Company extended the maturities of certain long-term debt (i) with the purchase of $6.0 billion of senior unsecured notes in March and April through tender offers and "make whole" redemptions and (ii) the issuance of $6.0 billion of additional senior unsecured notes maturing between 2032 and 2062.
In February, the company entered into accelerated share repurchase (ASR) transactions to repurchase $5 billion of Bristol Myers Squibb common stock. The company anticipates that these ASR transactions will be settled during the second and third quarters of 2022. (link)
Financial Guidance

Bristol Myers Squibb is adjusting its 2022 GAAP and non-GAAP line-item guidance as follows:

Guidance for Total Net Sales, Revlimid Sales and Recent LOE Sales, is being adjusted due to foreign exchange and faster erosion of Revlimid in International markets. The Company is also adjusting operating expenses due to foreign exchange as well as cost discipline.

GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD & licensing income due to ($0.10) incurred in Q1 and an additional ($0.11) due to the buyout of a future royalty obligation related to mavacamten that occurred in April 2022. Excluding these adjustments, the outlook for non-GAAP EPS is unchanged.

Key 2022 GAAP and non-GAAP line-item guidance assumptions are:

1 Key LOE Products = Revlimid and Abraxane
2 Operating Expenses = MS&A and R&D, excluding IPRD and Amortization of acquired intangibles
3 Inclusive of net impact of ($0.21) of acquired IPRD and licensing income

The 2022 financial guidance excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified and impact of future Acquired IPRD. Both GAAP and non-GAAP guidance assume current exchange rates. The 2022 non-GAAP EPS guidance is further explained under "Use of Non-GAAP Financial Information." The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

Environmental, Social & Governance (ESG)

As a leading biopharma company, we understand our responsibility extends well beyond the discovery, development, and delivery of innovative medicines. Our evolving Environmental, Social, and Governance (ESG) strategy builds on a legacy of comprehensive and global sustainability efforts. To learn more about our priorities and goals, please visit our latest ESG report.

Conference Call Information

Bristol Myers Squibb will host a conference call today at 8 a.m. EDT during which company executives will review the quarterly financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source To be directly connected to the conference call, enter your information here; the link will be active 15 minutes prior to the scheduled start time of the call, and does not require a dial-in number or operator assistance to be connected.

Investors and the public can also access the live webcast by dialing in the U.S. toll free 866-409-1555 or international +1 786-789-4797, confirmation code: 5513095. Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available on View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. EDT on April 29 through 11:30 a.m. EDT on May 13, 2022, by dialing in the U.S. toll free 888-203-1112 or international +1 719-457-0820, confirmation code: 5513095.