On May 7, 2020 Bristol Myers Squibb (NYSE:BMY) reported results for the first quarter of 2020, which highlight strong sales, robust operating performance and significant advancement of the company’s pipeline (Press release, Bristol-Myers Squibb, MAY 7, 2020, View Source [SID1234557304]).

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During this unprecedented period, Bristol Myers Squibb recognizes the critical role the company and its peers play in minimizing the impact of COVID-19 on citizens globally. The company is carrying out its mission of providing life-saving medicines to its patients while actively contributing to the fight against the COVID-19 pandemic, including supporting communities, promoting public health and contributing to collaborative COVID-19 research efforts.

"I am proud of the dedication and resiliency of our workforce who continue to deliver on our mission to help patients with serious disease as we all navigate the challenges of the COVID-19 pandemic," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. "Our teams have maintained a reliable supply of medicine globally, implemented innovative programs to ensure patients continue to have access to needed medicines and supported relief efforts around the world. This experience has brought our new company together in a way that reinforces our values and what we can do for patients."

Caforio continued, "The strength of our financial results and pipeline progress in the first quarter reflect continued successful execution across the company. We are well positioned to continue to successfully drive commercial execution of our inline business, launch new brands, progress our integration efforts and deliver our synergy targets while advancing our pipeline. Our financial strength enables us to maintain a capital allocation plan focused on commitment to our dividend, and prioritize debt-reduction and business development. The strength of our diversified portfolio and differentiated pipeline validate our strategy, and provide us with significant opportunities now and in the future."

*The pro forma revenues assume the company’s acquisition of Celgene (Celgene Acquisition) and Otezla divestiture occurred on January 1, 2019. See "Worldwide Product Revenue," which is available on bms.com/investors, 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.

FIRST QUARTER FINANCIAL RESULTS

All comparisons are made versus the same period in 2019 unless otherwise stated.

Bristol Myers Squibb posted first quarter revenues of $10.8 billion, an increase of 82% on a reported basis and 13% on a pro forma basis (as described above), or 8% excluding the impact of the COVID-19 pandemic. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019, representing 71% of the growth. The quarter benefitted by approximately $500 million due to COVID-19 related buying patterns. Revenues increased 83% when adjusted for foreign exchange.
U.S. revenues increased 96% to $6.8 billion in the quarter. International revenues increased 62% to $4.0 billion in the quarter. When adjusted for foreign exchange impact, international revenues increased 65%.
Gross margin as a percentage of revenue decreased from 69.2% to 66.0% in the quarter primarily due to the unwinding of inventory purchase price accounting adjustments, partially offset by product mix.
Marketing, selling and administrative expenses increased 60% to $1.6 billion in the quarter primarily due to $600 million of costs associated with the broader portfolio resulting from the Celgene Acquisition.
Research and development expenses increased 76% to $2.4 billion in the quarter primarily due to $1.0 billion of costs associated with the broader portfolio resulting from the Celgene Acquisition.
Amortization of acquired intangible assets was $2.3 billion in the quarter primarily due to the Celgene Acquisition.
Income taxes were $462 million despite a pre-tax loss of $304 million in the quarter primarily due to certain non-deductible expenses and purchase price adjustments. The effective tax rate was 13.3% in the same period a year ago.
The company reported net loss attributable to Bristol Myers Squibb of $775 million, or $0.34 per share, in the first quarter, compared to net earnings of $1.7 billion, or $1.04 per share, for the same period a year ago. The results in the current quarter include costs and expenses resulting from purchase price accounting, contingent value rights fair value adjustments, and other acquisition and integration expenses.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.0 billion, or $1.72 per share, in the first quarter, compared to net earnings of $1.8 billion, or $1.10 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.
Cash, cash equivalents and marketable debt securities were $19.0 billion and debt was $46.7 billion, as of March 31, 2020.
FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Product Revenue Highlights

Global product revenue increases in the first quarter of 2020, as compared to the first quarter of 2019, drove revenue increases.

* Represents products acquired in connection with the Celgene Acquisition. See "Worldwide Product Revenue," which is available on bms.com/investors, for information on the revenue for these products and other products of the company and Celgene for the prior-year period.

Oncology

Opdivo

Regulatory

In April, the company announced that the U.S. Food and Drug Administration (U.S. FDA) accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab), administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations (CheckMate -9LA). The U.S. FDA granted this application Priority Review with a target action date of August 6, 2020, in addition to granting Fast Track designation. Additionally, the European Medicines Agency (EMA) validated a type II variation application for Opdivo plus Yervoy, combined with limited chemotherapy, for the same indication. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. (link)
In March, the company announced the U.S. FDA approved Opdivo plus Yervoy to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. (link)
In February, the company announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Opdivo for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy. (link)
Clinical

In April, the company and Exelixis, Inc., announced positive topline results for the Phase 3 trial CheckMate -9ER, which evaluated Opdivo plus Cabometyx versus sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC). The study met its primary and secondary endpoints. (link)
In April, the company announced positive topline results for the Phase 3 trial CheckMate –743 based on an interim analysis, which evaluated Opdivo plus Yervoy in previously untreated malignant pleural mesothelioma. The study met its primary endpoint. (link)
In February, at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in San Francisco, the company announced important new data for Opdivo and Opdivo plus Yervoy:
Five-year follow-up results from the Phase 3 CheckMate -025 study, which evaluated Opdivo versus everolimus in patients with previously treated advanced or metastatic RCC. (link)
Updated results from the Phase 3 CheckMate -214 study evaluating Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic RCC. (link)
Cabometyx is a registered trademark of Exelixis, Inc.

Hematology

liso-cel

Regulatory

In May, the company announced that the U.S. FDA extended the action date by three months for the BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The new U.S. FDA action date is November 16, 2020. (link)
CC-486

Regulatory

In May, the company announced that the U.S. FDA accepted for Priority Review its New Drug Application (NDA) for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukemia (AML) with an FDA action date of September 3, 2020. (link)
Reblozyl

Regulatory

In April, the company and Acceleron Pharma, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy and adult patients with transfusion-dependent anemia associated with beta thalassemia. (link)
In April, the company and Acceleron Pharma, Inc. announced the U.S. FDA approved Reblozyl for the treatment of anemia failing an erythropoiesis stimulating agent and requiring two or more red blood cell (RBC) units over 8 weeks in adults with very low- to intermediate-risk MDS-RS or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis. (link)
In March, the company and Acceleron Pharma, Inc. announced that the New England Journal of Medicine published results from BELIEVE, the pivotal Phase 3 study evaluating the safety and efficacy of Reblozyl for the treatment of anemia in adults with beta thalassemia who require regular RBC transfusions. (link)
ide-cel

Regulatory

In March, the company and bluebird bio, Inc. announced the submission of their Biologics License Application (BLA) to the U.S. FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies. (link)
Empliciti

Clinical

In March, the company announced topline results from ELOQUENT-1, a Phase 3, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. (link)
Immunology

Zeposia

Regulatory

In March, the company announced that the U.S. FDA approved Zeposia (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. (link)
In March, the company announced that the CHMP of the EMA adopted a positive opinion for Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. The CHMP recommendation will be reviewed by the European Commission, which has the authority to approve medicines for the European Union. (link)
Business Development Updates

In March, the company and Voluntis announced a collaboration agreement to create and investigate digital therapeutic solutions that will support cancer patients. (link)
COVID-19 Pandemic Response

During the current world health crisis, the company will continue 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. (link)

Some specific actions:

Working with researchers, the biotech community and the broader life sciences industry on ways we together can accelerate therapies for COVID-19. This includes evaluating medicines in our portfolio that may have an impact on the inflammatory immune response associated with COVID-19.
Expanding the existing Bristol Myers Squibb patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to branded Bristol Myers Squibb medicine for free, including some of its most widely prescribed products, as well as those prescribed via telehealth services. (link)
Contributing to COVID-19 relief efforts across the globe, including donating protective personal equipment and other equipment in the United States, as well as donating funds, equipment and expertise in individual international markets. Additionally, the Bristol Myers Squibb Foundation, 501(c)(3) organization, has provided more than $6 million in financial support to COVID-19 related relief efforts, including $2.5 million to human service organizations and patient support groups providing food services, critical education and aid to vulnerable populations.
Supporting our employees who are qualified to provide medical services and wish to aid communities affected by the pandemic as well as supporting our colleagues across the world who are virtually volunteering their skills and time.
Financial Guidance

Bristol Myers Squibb is updating its 2020 GAAP EPS guidance range from $0.75 – $0.95 to $0.37 to $0.57. In addition, the company is affirming its 2020 non-GAAP EPS guidance range of $6.00 to $6.20 and 2021 non-GAAP EPS guidance range of $7.15 to $7.45. Adjusted 2020 GAAP and non-GAAP line items are:

The 2020 and 2021 guidance assumes the peak impact of the current COVID-19 crisis on our business occurs in the second quarter of 2020, with a return to a more stable business environment in the third quarter and minimal impact from the fourth quarter of 2020 onwards. Additional key factors assumed in guidance include:

Mid-April foreign exchange and interest rates apply
A reduction in new-to-brand prescriptions, and on physician administered product demand during the second quarter sees recovery during the third quarter and fully recovered in the fourth quarter
Products that saw significant advanced buying at the end of the first quarter will see that inventory work-down during the rest of the year, mostly in the second quarter and to a lesser degree in third and fourth quarters
All clinical trial activities are planned to resume by the end of the year where local country restrictions have been lifted
The 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 guidance also excludes macro economic effects due to the COVID-19 pandemic that are not yet quantifiable. The 2020 and 2021 non-GAAP EPS guidance further excludes other specified items as discussed under "Use of Non-GAAP Financial Information." A reconciliation of non-GAAP financial measures to the most comparable GAAP measure and the reasons why management believes the use of these measures is important are provided in supplemental materials available on the company’s website. For 2021 non-GAAP EPS guidance, there is no reliable or reasonably estimable comparable GAAP measure as discussed below. 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 May 7 at 8:30 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 bms.com/investors, by dialing in the U.S. toll free 888-256-1007 or international 1-786-789-4797, confirmation code: 3261903, or use this link which becomes active 15 minutes prior to the scheduled start time and enter 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 12 p.m. ET on May 7 through 12 p.m. ET on May 21, 2020. The replay will also be available through bms.com/investors or by dialing in the U.S. toll free 888-203-1112 or international 1-719-457-0820, confirmation code: 3261903.

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 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, divestiture gains or losses, stock compensation resulting from accelerated vesting of Celgene awards, certain retention-related compensation charges related to the Celgene Acquisition, pension, legal and other contractual settlement charges, interest expense on the notes issued in May 2019 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 of the U.S. tax reform. 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.

Amortization of acquired intangible assets were previously included in non-GAAP earnings and EPS information. These amounts have become significant to the financial results subsequent to the Celgene Acquisition and as a result, have been excluded in the non-GAAP results to better reflect our core operating performance. Comparable prior period non-GAAP results have not been revised to include this adjustment as the related amounts were insignificant ($24 million for the three months ended March 31, 2019).

In connection with presenting our outlook, we are also providing non-GAAP EPS guidance for 2021. There is no reliable or reasonably estimable comparable GAAP measure for this because we are not able to reliably predict the impact of specified items beyond the next twelve months. As a result, the reconciliation of this non-GAAP measure to the most directly comparable GAAP measure 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.