Bristol-Myers Squibb Reports First Quarter Financial Results

• Bristol-Myers Squibb

Bristol-Myers Squibb Company has reported results for the first quarter of 2016, which were highlighted by strong sales for Opdivo, Eliquis and their hepatitis C franchise along with significant regulatory milestones and key data in Immuno-Oncology.

“We had a very good first quarter highlighted by strong sales growth and significant progress in bringing the promise of Immuno-Oncology across multiple types of cancer to patients,” said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “The launch of Opdivo continues to accelerate with data in new cancers, additional indications and continued rapid market adoption. By growing our business and advancing our pipeline, we are successfully executing our growth strategy.”

FIRST QUARTER FINANCIAL RESULTS

• Bristol-Myers Squibb posted first quarter 2016 revenues of $4.4 billion, an increase of 9% compared to the same period a year ago. Global revenues increased 11% adjusted for foreign exchange impact. Excluding Abilify and Erbitux, global revenues increased 31% or 34% adjusted for foreign exchange impact.
• U.S. revenues increased 24% to $2.5 billion in the quarter compared to the same period a year ago. International revenues decreased 7%. When adjusted for foreign exchange impact, international revenues decreased 2%.
• Gross margin as a percentage of revenues was 76.0% in the quarter compared to 79.0% in the same period a year ago.
• Marketing, selling and administrative expenses increased 4% to $1.1 billion in the quarter.
• Research and development expenses increased 12% to $1.1 billion in the quarter.
• The effective tax rate was 27.1% in the quarter, compared to 17.2% in the first quarter last year.
• The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.71 per share, in the quarter compared to net earnings of $1.2 billion, or $0.71 per share, a year ago.
• The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.74 per share, in the first quarter, compared to $1.2 billion, or $0.71 per share, for the same period in 2015. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
• Cash, cash equivalents and marketable securities were $8.0 billion, with a net cash position of $1.3 billion, as of March 31, 2016.

FIRST QUARTER PRODUCT AND PIPELINE UPDATE

Global revenues for the first quarter of 2016, compared to the first quarter of 2015, were driven by Opdivo, which grew by $664 million; Eliquis, which grew by $379 million; Hepatitis C Franchise, which grew 62%; Orencia, which grew 19%; and Sprycel, which grew 9%.

Opdivo

• In April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Opdivo for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. The designation is based on results of CheckMate -141, a Phase 3, open-label, randomized trial evaluating Opdivo versus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within six months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting. This trial was stopped early in January 2016 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival (OS).
• In April, the FDA accepted for filing and review a Supplemental Biologics License Application (sBLA) for Opdivowhich seeks to expand use to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate -205 data, which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin.
• In April, the European Commission (EC) approved Opdivo monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The approval expands Opdivo’s existing lung cancer indication in previously treated metastatic squamous NSCLC to include the non-squamous patient population. Opdivo is the only approved PD-1 immune checkpoint inhibitor to demonstrate superior OS in two separate Phase 3 trials in previously treated metastatic NSCLC, regardless of PD-L1 expression; one trial in squamous NSCLC (CheckMate -017) and the other in non-squamous NSCLC (CheckMate -057), which were the basis of this approval. The approval allows for the expanded marketing of Opdivo in previously treated metastatic NSCLC in all 28 Member States of the European Union.
• In April, the EC approved Opdivo monotherapy for advanced renal cell carcinoma (RCC) after prior therapy in adults. Opdivo is the first and only PD-1 immune checkpoint inhibitor approved in Europe to demonstrate an OS benefit versus a standard of care in this patient population. The approval is based on the results of the Phase 3 study CheckMate -025, which evaluated Opdivo in patients with advanced clear-cell RCC who received prior anti-angiogenic therapy compared to everolimus. This approval allows for the expanded marketing of Opdivo in previously treated advanced RCC in all 28 Member States of the European Union.
• In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.
• In April, the company announced results from three studies for Opdivo and the Opdivo + Yervoy Regimen:
• CheckMate -141: In this Phase 3 open-label, randomized trial, evaluating Opdivo in patients with recurrent or metastatic SCCHN after platinum therapy compared to investigator’s choice of therapy, Opdivo met the primary endpoints and demonstrated statistically significant OS versus three standards of care (cetuximab, docetaxel, or methotrexate). In the trial, patients treated with Opdivo had a one-year survival rate of 36% compared to 16.6% for investigator’s choice, and experienced a 30% reduction in the risk of death. Median OS was 7.5 months for Opdivo compared to 5.1 months for investigator’s choice. The safety profile of Opdivoin CheckMate -141 was consistent with prior studies, with no new safety signals identified.
• CheckMate -069: In this Phase 2 trial, which is the first randomized study to evaluate the Opdivo + Yervoycombination regimen in patients with previously untreated advanced melanoma, the combination regimen demonstrated a two-year OS rate of 69% compared to 53% for Yervoy alone in patients with BRAF wild-type advanced melanoma. Similar results were observed in the overall study population, with an OS rate of 64% at two years for the combination regimen compared to 54% for Yervoy alone. A change in tumor burden was also seen with the combination regimen, with a median change of 70% compared to 5% for Yervoy alone. Overall survival was an exploratory endpoint in this trial. The safety profile of the Opdivo + Yervoy combination regimen in this study was consistent with previously reported studies.
• CA209-003: In this Phase 1 study, evaluating Opdivo monotherapy in heavily pretreated advanced melanoma, the company reported extended follow-up, including five-year OS rates. This data represents the longest survival follow-up of patients who received an anti-PD-1 therapy in a clinical trial. At five years, Opdivodemonstrated a durable and consistent survival benefit with an OS rate of 34%, with an evident plateau in survival at approximately 4 years. The safety profile of Opdivo in Study 003 was similar to previously reported studies, with no new safety signals identified.
• In March, the EMA validated a type II variation application, which seeks to extend the current indications forOpdivo to include the treatment of patients with cHL after prior therapies. The application included data from CheckMate -205, a Phase 2 study which evaluated Opdivo in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

Empliciti

• In January, the company and its partner, AbbVie, Inc., announced the CHMP adopted a positive opinion recommending Empliciti, an investigational immunostimulatory antibody, be granted approval for the treatment of multiple myeloma as combination therapy with Revlimid^® and dexamethasone in patients who have received at least one prior therapy. The application will now be reviewed by the EC, which has the authority to approve medicines for the European Union. The CHMP positive opinion is based on data from the Phase 3, open-label ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.

Daklinza

• In February, the FDA approved Daklinza, an NS5A replication complex inhibitor, in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 (human immunodeficiency virus) coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is also available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. The approval is based on data evaluating the Daklinza regimens from the Phase 3 ALLY-1 and ALLY-2 clinical trials.
• In February, the company announced results from the first completed all-oral chronic HCV regimen Phase 3 trial that includes a Chinese patient population. In the study, which evaluated Daklinza in combination with asunaprevir for 24 weeks in Asian (non-Japanese) patients with genotype 1b HCV, 91% of patients from China achieved sustained virologic response at post-treatment week 24 (SVR24), which rose to 98% of patients without NS5A resistance-associated variants (RAVs) at baseline. SVR24 results were similarly high across all subgroups with genotype 1b HCV, including those with cirrhosis, and patients from Korea and Taiwan. SVR24 rates were also higher in all patients without baseline NS5A RAVs, regardless of the presence or absence of cirrhosis, and lower in patients with baseline NS5A RAVs. Results were presented at the Asian Pacific Association for the Study of the Liver Conference in Tokyo.
• In January, the EC approved Daklinza for the treatment of chronic HCV in three new patient populations which provides additional treatment options for multiple HCV patient populations, including difficult-to-treat patients with decompensated cirrhosis. The expanded label allows for the use of Daklinza in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV. The approval is based on data from the Phase 3 ALLY-2 and ALLY-2 clinical trials.

Revlimid^® is a trademark of Celgene Corporation.

BUSINESS DEVELOPMENT UPDATE

• In April, the company acquired Padlock Therapeutics, Inc. (Padlock), a private, Cambridge, Massachusetts-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases. The acquisition gives the company full rights to Padlock’s Protein/Peptidyl Arginine Deiminase (PAD) inhibitor discovery program focused on the development of potentially transformational treatment approaches for patients with rheumatoid arthritis. Padlock’s PAD discovery program may have additional utility in treating systemic lupus erythematosus and other autoimmune diseases.
• In March, the company entered into an agreement with LabCentral, an innovative, shared laboratory space designed as a launch pad for life-sciences and biotech startup companies, to become a LabCentral platinum sponsor. The company can nominate up to two innovative life-sciences and biotech startup companies per year to take up residence in LabCentral’s Kendall Square facilities.
• In February, the company and its partner, Pfizer Inc., announced a collaboration agreement with Portola Pharmaceuticals Inc. to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis. This agreement builds on the companies’ existing clinical collaboration to develop andexanet alfa in the U.S. and Europe.
• In February, the company entered into a research collaboration agreement with the Dana-Farber Cancer Institute as part of the Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S. As part of the I-O RPM program, the company and the Dana-Farber Cancer Institute will conduct a range of early phase clinical studies and Bristol-Myers Squibb will support the training of young investigators who contribute to the I-O RPM program at Dana-Farber.
• In February, the company completed the previously announced sale of its HIV R&D portfolio to ViiV Healthcare. The sale included a number of programs at different stages of discovery, preclinical and clinical development. The agreements with ViiV Healthcare do not impact the company’s marketed HIV medicines, including Reyataz,Evotaz, Sustiva and Atripla.

2016 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2016 GAAP EPS guidance range from $2.30 - $2.40 to $2.37 - $2.47. The company is also increasing its non-GAAP EPS guidance range from $2.30 - $2.40 to $2.50 - $2.60. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2016 non-GAAP guidance assumptions include:

• Worldwide revenues increasing in the low-double digit range.
• Marketing, sales and administrative expenses decreasing in the low-single digit range.
• Research and development expenses increasing in the low-double digit range.

The financial guidance for 2016 excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2016 guidance also excludes other specified items as discussed under “Use of Non-GAAP Financial Information.” Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.