On February 4, 2021 Bristol Myers Squibb (NYSE:BMY) reported results for the fourth quarter and full year of 2020, which reflect robust sales, strong operating performance and advancement of the company’s product pipeline (Press release, Bristol-Myers Squibb, FEB 4, 2021, View Source [SID1234574618]).
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!
"In our first full year as a new company we delivered solid operational and financial results, and laid a strong foundation for the future," said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "I am grateful to our team whose resilience and continued focus enabled us to grow our inline business, launch promising new drugs and significantly advance our pipeline while keeping our colleagues safe and maintaining the supply of our medicines to patients. The growth opportunities from our in-line and launch portfolios combined with a robust product pipeline and disciplined business development strategy strongly position the company to accelerate the renewal of our portfolio and achieve long-term sustainable growth."
*The pro forma revenues assume the company’s acquisition of Celgene Corporation (Celgene Acquisition) and its divestiture of Otezla to Amgen Inc. (Otezla Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. Management believes that measuring revenue rates on a comparable pro forma basis is an appropriate way for investors to best understand the underlying performance of the business. The pro forma revenue is presented for informational purposes only and does not purport to project the company’s revenue, results of operations or financial position for any future period or as of any future date. See "Worldwide Pro Forma Revenue" in Quarterly Package of Financial Information for this quarter and full year of 2020, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Otezla is a trademark of Amgen Inc.
**In excess of +100%
FOURTH QUARTER FINANCIAL RESULTS
All comparisons are made versus the same period in 2019 unless otherwise stated.
Bristol Myers Squibb posted fourth quarter revenues of $11.1 billion, an increase of 39% on a reported basis and 10% on a pro forma basis. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019.
U.S. revenues increased 43% to $6.8 billion in the quarter. International revenues increased 34% to $4.3 billion in the quarter. When adjusted for foreign exchange impact, international revenues increased 30%.
Gross margin increased from 68.6% to 73.7% in the quarter primarily due to product mix, lower unwinding of inventory purchase price accounting adjustments, partially offset by an impairment charge related to Inrebicmarketed product rights.
Marketing, selling and administrative expenses increased 57% to $2.7 billion in the quarter primarily due to $400 million of costs associated with the broader portfolio resulting from the Celgene Acquisition, as well as higher advertising and promotion expenses and cash settlement of MyoKardia unvested stock awards.
Research and development expenses increased 79% to $3.8 billion in the quarter primarily due to $500 million of costs associated with the broader portfolio resulting from the Celgene Acquisition, as well as license and acquisition charges related to Dragonfly, an in-process research and development (IPR&D) impairment charge related to the discontinuation of the orva-cel program development and cash settlement of MyoKardia unvested stock awards.
Amortization of acquired intangible assets increased to $2.5 billion in the quarter reflecting the full quarter amortization from the Celgene Acquisition.
IPR&D charge of $11.4 billion was included in the quarter due to the MyoKardia transaction being accounted for as an asset acquisition.
The effective tax benefit rate was 4.1% in the current quarter and includes the impact of the non-deductible MyoKardia IPR&D charge. Income taxes were $931 million despite pre-tax loss of $129 million in the same period a year ago primarily due to the Otezla divestiture, certain non-deductible expenses and purchase price adjustments.
The company reported net loss attributable to Bristol Myers Squibb of $10.0 billion, or $4.45 per share, in the fourth quarter, compared to net loss of $1.1 billion, or $0.55 per share, for the same period a year ago. The results in the current quarter include costs and expenses resulting from the IPRD charge related to the MyoKardia asset acquisition, purchase price accounting from the Celgene Acquisition, contingent value rights fair value adjustments, equity investment gains, intangible assets impairment charges and other acquisition and integration expenses.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.3 billion, or $1.46 per share, in the fourth quarter, compared to non-GAAP net earnings of $2.4 billion, or $1.22 per share, for the same period a year ago. A discussion of the non-GAAP financial measures is included under the "Use of Non-GAAP Financial Information" section.
*In excess of +100%. Product rights were acquired as part of the Celgene Acquisition.
**Pro forma product revenues assume the Celgene Acquisition and the Otezla Divestiture occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. Management believes that measuring product revenue rates on a comparable pro forma basis is an appropriate way for investors to best understand the underlying performance of the business. The pro forma product revenue is presented for informational purposes only and does not purport to project product revenue for any future period or as of any future date. See "Worldwide Pro Forma Revenues" in the Quarterly Package of Financial Information for this quarter and full year of 2020, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the product revenue of the company and Celgene for the prior-year period. Otezla is a trademark of Amgen Inc.
*In excess of +100%. Product rights were acquired as part of the Celgene Acquisition.
**Pro forma product revenues assume the Celgene Acquisition and the Otezla Divestiture occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. Management believes that measuring product revenue rates on a comparable pro forma basis is an appropriate way for investors to best understand the underlying performance of the business. The pro forma product revenue is presented for informational purposes only and does not purport to project product revenue for any future period or as of any future date. See "Worldwide Pro Forma Revenues" in the Quarterly Package of Financial Information for this quarter and full year of 2020, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the product revenue of the company and Celgene for the prior-year period. Otezla is a trademark of Amgen Inc.
FOURTH QUARTER PRODUCT AND PIPELINE UPDATE
Oncology
Opdivo
Regulatory
In January, the company announced that the U.S. Food & Drug Administration (FDA) approved OPDIVO(nivolumab) in combination with CABOMETYX(cabozantinib), for the first-line treatment of patients with advanced renal cell carcinoma. The approval is based on the Phase 3 Checkmate -9ER trial. (link)
In January, the company announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The U.S. FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.(link)
In January, the company announced that the U.S. FDA has accepted its supplemental sBLA for Opdivo for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT), based on results from the Phase 3 CheckMate -577 trial. The U.S. FDA granted the application Priority Review and assigned a PDUFA goal date of May 20, 2021.(link)
In January, the company announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo,based on results from the Phase 3 CheckMate -577 trial, as an adjuvant treatment for esophageal or GEJ cancer in adult patients with residual pathologic disease after neoadjuvant chemoradiotherapy (CRT) and resection. (link)
In January, the EMA validated the Type II Variation MAA for Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with advanced or metastatic gastric cancer (GC), GEJ cancer or esophageal adenocarcinoma (EAC). The filing was based on the Phase 3 CheckMate -649 trial. (link)
In November, the company announced that the European Commission (EC) has approved Opdivo for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy. (link)
In November, the company announced that the EC, based on results from the Phase 3 CheckMate -9LA trial, has approved Opdivo plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. (link)
Clinical
In December, the company announced that CheckMate -548, a Phase 3 trial evaluating the addition of Opdivo to the current standard of care (temozolomide and radiation therapy) in patients with newly diagnosed glioblastoma multiforme (GBM) with O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation following surgical resection of the tumor, did not meet its primary endpoint of overall survival (OS) in patients with no baseline corticosteroid use or in the overall randomized population. (link)
Hematology
Revlimid
Patent Update
In December, the company announced that its wholly owned subsidiary, Celgene, and Cipla Limited (Cipla) have settled their litigation related to patents for REVLIMID (lenalidomide). (link)
Inrebic
Regulatory
In December, the company announced the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of Inrebic(fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase(JAK) inhibitor naïve or have been treated with ruxolitinib. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the EU. (link)
Medical Conferences
In December, at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the company announced important new data and analysis from its hematology portfolio:
QUAZAR AML-001: a study evaluating Onureg(azacitidine tablets; CC-486), an oral hypomethylating agent, as a treatment for adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy. (link)
TRANSCEND CLL 004: longer-term follow-up from the Phase I study evaluating liso-cel in relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma with liso-cel as monotherapy and initial results from the combination cohort with ibrutinib. (link)
TRANSCEND NHL 001: safety and efficacy results in the cohort of patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) treated with liso-cel. (link)
OUTREACH: initial results evaluating outcomes of treatment with liso-cel for patients with relapsed or refractory large B-cell lymphoma (LBCL) across inpatient and outpatient settings. (link)
First efficacy and safety results from a triplet combination study including iberdomide, a cereblon E3 ligase modulator (CELMoD) agent, with daratumumab or bortezomib and dexamethasone in patients with heavily pretreated R/R multiple myeloma. (link)
The following data were also presented at the 2020 ASH (Free ASH Whitepaper) Annual Meeting by the company and bluebird bio, Inc. (Nasdaq: BLUE):
Phase 1 CRB-401: longer-term data from the original Phase 1 CRB-401 study evaluating the companies’ investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR) T cell therapy, idecabtagene vicleucel (ide-cel) in relapsed and refractory multiple myeloma (RRMM). (link)
Phase 2 KarMMA: analyses from the Phase 2 KarMMA study of patients with triple-class exposed relapsed and refractory multiple myeloma (RMM). (link)
Immunology
Deucravacitinib (BMS-986165; TYK2 inhibitor)
Clinical
In February, the company announced results from POETYK PSO-2, the second Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-2 met both co-primary endpoints evaluating deucravacitinib versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI 75) and Physician’s Global Assessment (sPGA) scales and met multiple key secondary endpoints versus Otezla (apremilast). (link)
Zeposia
Clinical
In February, the company announced that U.S. FDA has accepted its supplemental New Drug Application (sNDA) for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC). The FDA granted Priority Review to the application and assigned a PDUFA goal date, or target action date, of May 30, 2021. (link)
In December, the company announced that the EMA has validated its MAA for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). (link)
Medical Conferences
In November, at the American College of Rheumatology (ACR) Convergence 2020, the company announced important new data and analysis across its Immunology portfolio:
deucravacitinib (BMS-986165): results from an ongoing Phase 2 study evaluating the safety and efficacy of deucravacitinib (BMS-986165) compared with placebo in adults with active psoriatic arthritis met the primary endpoint. (link)
Iberdomide: results from a Phase 2b trial in patients with active systemic lupus erythematosus (SLE) assessing iberdomide met its primary endpoint in patients with high Type 1 interferon or Aiolos gene expressions. (link)
Business Development
In November, the company announced that it has successfully completed its acquisition of MyoKardia (MyoKardia Acquisition) in an all cash transaction for approximately $13.1 billion. (link)
Capital Allocation
The company continues to maintain a consistent, balanced approach to capital allocation focused on prioritizing investment for growth through business development along with reducing debt, commitment to dividend growth and share repurchase.
Today, the company announced a debt tender offer for an aggregate purchase price of up to $4.0 billion. (link)
In January 2021, the company announced that its Board of Directors has authorized incremental share repurchases of up to an additional $2 billion of the company’s outstanding shares of common stock. With this increase, the remaining share repurchase capacity under the company’s share repurchase program was approximately $6.4 billion. During 2021, the company plans to repurchase $3.0-$4.0 billion of its shares. (link)
Commitment to Sustainability, Diversity and Inclusion
In December, the company announced it is strengthening its commitment to environmental sustainability on a global basis by setting new 2030 and 2040 goals. By 2030, the company will purchase 100% of the electricity it uses from renewable sources, and by 2040, it will be carbon neutral in its Scope 1 (direct) and Scope 2 (indirect) emissions and reach the targets of equitable water use, zero waste to landfill and 100% electric vehicles in its fleet. (link)
In November, the Bristol Myers Squibb Foundation and National Medical Fellowships announced that they will leverage $100 million of the previously announced commitment from Bristol Myers Squibb and the Bristol Myers Squibb Foundation to diversity and inclusion to develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural U.S. communities. (link)
COVID-19 Pandemic Response
During the current world health crisis, the company continues to take all necessary actions to promote public health by carrying out its mission of providing life-saving medicines to the patients who depend on the company and supporting relief efforts across the globe. (link)
In February, the company and The Rockefeller University announced that they have entered into a definitive agreement under which Bristol Myers Squibb has been granted a global exclusive license to develop, manufacture, and commercialize Rockefeller’s novel monoclonal antibody ("mAb") duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. (link)
Financial Guidance
Bristol Myers Squibb is providing 2021 GAAP EPS guidance in the range of $3.12-$3.32 and is increasing its non-GAAP EPS guidance range from $7.15 – $7.45 to $7.35 – $7.55. Both GAAP and non-GAAP guidance assume current exchange rates. Key 2021 GAAP and non-GAAP line item guidance assumptions are:
Worldwide revenues increasing in the high-single digits.
Gross margin as a percentage of revenue to be approximately 80.5%.
Marketing, selling and administrative expenses to be in-line with 2020 levels for GAAP and increasing in the low-single digit range for non-GAAP.
Research and development expenses decreasing in the high-single digits for GAAP and increasing in the mid-single digits for non-GAAP.
An effective tax rate of approximately 22% for GAAP and approximately 16% for non-GAAP.
The 2021 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. The 2021 non-GAAP EPS guidance is explained and further excludes other specified items as discussed 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.
Long-term Financial Targets
Bristol Myers Squibb is also affirming 2020-2025 long-term financial targets communicated in January 2021 (link):
Expects low to mid-single digit revenue CAGR and low double-digit revenue CAGR excluding Revlimid & Pomalyst at constant exchange rates
Expects to maintain low to mid-40s percent non-GAAP operating margin
Expects significant cash flow generation of $45-$50 billion dollars from 2021 -2023.
This financial guidance excludes the impact of any potential future strategic acquisitions and divestitures as well as any specified items as discussed under "Use of Non-GAAP Financial Information." There is no reliable or reasonably estimable comparable GAAP measures for this non-GAAP financial guidance. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.
Company and Conference Call Information
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
There will be a conference call on February 4 at 10 a.m. ET during which company executives will review financial information 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 or by dialing in the U.S. toll free 800-458-4121 or international +1 313-209-6672, confirmation code: 4441406, or using this link which becomes active 15 minutes prior to the scheduled start time and entering your information to be connected. Materials related to the call will be available at the same website prior to the conference call.
A replay of the call will be available beginning at 1:30 p.m. ET on February 4 through 1:30 p.m. ET on February 18, 2021. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4441406.
Use of Non-GAAP Financial Information
This earnings release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and also available on the company’s website at www.bms.com.
These non-GAAP items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets beginning in the fourth quarter of 2019, including product rights that generate a significant portion of our ongoing revenue, unwind of inventory fair value adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges or other income resulting from upfront or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, costs of acquiring a priority review voucher, IPRD charge resulting from the MyoKardia acquisition, divestiture gains or losses, stock compensation resulting from accelerated vesting of Celgene awards, certain retention-related employee compensation charges related to the Celgene Acquisition, pension, legal and other contractual settlement charges, interest expense on the notes issued in May 2019 incurred prior to the Celgene Acquisition and interest income earned on the net proceeds of those notes, equity investment and contingent value rights fair value adjustments and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from internal transfer of intangible assets and the Otezla Divestiture. This earnings release also provides international revenues excluding the impact of foreign exchange.
Non-GAAP information is intended to portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information are indications of the company’s baseline performance before items that are considered by us to not be reflective of the company’s ongoing results. In addition, this information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
In connection with presenting our outlook, we are also providing revenue (ex-FX) and non-GAAP operating margin guidance for 2020-2025. There are no reliable or reasonably estimable comparable GAAP measures for this because we are not able to reliably predict the impact of specified items or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on our future GAAP results.
Website Information
We routinely post important information for investors on our website, BMS.com, in the "Investors" section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.