OREANDA-NEWS. Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the second quarter of 2015, which were highlighted by strong global sales, key regulatory and clinical advances for Opdivo and significant clinical data on the company’s Immuno-Oncology portfolio presented at the American Society of Clinical Oncology (ASCO).

“We had a very good quarter, with strong sales across our portfolio, encouraging results from clinical trials and important regulatory milestones,” said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “I am excited by our progress in Immuno-Oncology as we continue to advance our leadership position and transform cancer treatment. As our Immuno-Oncology data continues to emerge, it is clear we have a tremendous opportunity, and we are making the right strategic investments to capitalize on the full potential of our portfolio.”

         
        Second Quarter
  $ amounts in millions, except per share amounts              
        2015   2014   Change
  Total Revenues     $4,163   $3,889   7%
  GAAP Diluted EPS     (0.08)   0.20   **
  Non-GAAP Diluted EPS     0.53   0.48   10%
                 

**In excess of +/- 100%

SECOND QUARTER FINANCIAL RESULTS

  • Bristol-Myers Squibb posted second quarter 2015 revenues of $4.2 billion, an increase of 7% compared to the same period a year ago. Global revenues increased 16% adjusted for foreign exchange impact.
  • U.S. revenues decreased 3% to $1.8 billion in the quarter compared to the same period a year ago. International revenues increased 17%.
  • Gross margin as a percentage of revenues was 75.7% in the quarter compared to 74.5% in the same period a year ago.
  • Marketing, selling and administrative expenses increased 2% to $968 million in the quarter.
  • Advertising and product promotion spending decreased 11% to $167 million in the quarter.
  • Research and development expenses increased 31% to $1.9 billion in the quarter, primarily due to the acquisition of Flexus Biosciences, Inc.
  • The effective tax rate was 311.5% in the quarter, compared to 25.4% in the second quarter last year.
  • The company reported net loss attributable to Bristol-Myers Squibb of $130 million, or $0.08 per share, in the quarter compared to net earnings of $333 million, or $0.20 per share, a year ago. The results in the current quarter include an $800 million R&D charge ($0.48 per share) resulting from the Flexus acquisition, which was not deductible for tax purposes.
  • The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $890 million, or $0.53 per share, in the second quarter, compared to $798 million, or $0.48 per share, for the same period in 2014. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
  • Cash, cash equivalents and marketable securities were $10.1 billion, with a net cash position of $2.7 billion, as of June 30, 2015.

SECOND QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the second quarter included Eliquis, which grew by $266 million, Orencia, which grew 15%, Sprycel, which grew 10%, and Opdivo, which had sales of $122 million. Daklinza and Sunvepra had combined sales of $479 million, which includes $170 million of previously deferred revenue in France as part of an early access program before final pricing was obtained.

Opdivo

  • In July, the European Medicines Agency (EMA) validated two of the company’s type II variation applications, which seek to extend the current indication for Opdivo. Validation of the applications confirms that the submissions are complete and starts the EMA's centralized review process. In lung cancer, the proposed new indication addresses the non-squamous, NSCLC population and is based on data from the Phase 3 CheckMate -057 study: Opdivo as monotherapy for the treatment of locally advanced or metastatic non-squamous NSCLC after prior chemotherapy in adults. In melanoma, the proposed new indication aims at extending the use of Opdivo monotherapy in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults and is based on data from the Phase 3 CheckMate -067 study, Phase 2 CheckMate -069 study and the Phase 1b CA209-004 study.
  • In July, the European Commission (EC) approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy. This approval marks the first major treatment advance in squamous NSCLC in more than a decade in the European Union (EU). Nivolumab is the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival in previously treated metastatic squamous NSCLC. This approval allows for the marketing of nivolumab in all 28 Member States of the EU.
  • In July, the company announced that an open-label, randomized Phase 3 study evaluating Opdivo versus everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (CheckMate -025) was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.
  • In June, the EC approved Opdivo for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. Opdivo is the first PD-1 immune checkpoint inhibitor to have received EC approval, which allows Opdivo to be marketed in all 28 Member States of the EU.
  • In June, the U.S. Food and Drug Administration (FDA) accepted for filing and review the supplemental Biologics License Application (sBLA) for the Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma, the first regulatory milestone for an immuno-oncology combination regimen in cancer. The FDA also granted Priority Review for this application, which includes data from CheckMate -069. The projected FDA action date is September 30, 2015.
  • In May, during ASCO in Chicago, the company announced results from three Phase 3 trials for

    Opdivo:

    • CheckMate -057 – In this study evaluating previously treated patients with advanced non-squamous NSCLC, Opdivo became the first PD-1 immune checkpoint inhibitor to demonstrate superior overall survival versus standard of care (docetaxel). A 27% reduction in the risk of progression or death – the primary study endpoint – was reported for Opdivo versus docetaxel. Opdivo was associated with a doubling of overall median survival across the continuum of PD-L1 expression, starting at 1% level of expression. The safety profile of Opdivo in CheckMate -057 was favorable versus docetaxel with grade 3-5 treatment-related adverse events reported in 10% of patients who were treated with Opdivo versus 54% in the docetaxel arm.
    • CheckMate -017 – In this open-label, randomized study evaluating Opdivo versus docetaxel in previously treated patients with advanced squamous NSCLC, Opdivo demonstrated an overall survival rate of 42% at one year versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. Opdivo reduced the risk of death by 41%. The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. The results were published in The New England Journal of Medicine (NEJM).
    • CheckMate -067 – In this study evaluating the Opdivo+Yervoy regimen and Opdivo monotherapy versus Yervoy monotherapy in patients with previously untreated advanced melanoma, both the Opdivo+Yervoy regimen and Opdivo monotherapy demonstrated superiority to Yervoy, the current standard of care, for the co-primary endpoint of progression-free survival (PFS). Median PFS was 11.5 months for the Opdivo+Yervoy regimen and 6.9 months for Opdivo monotherapy, versus 2.9 months for Yervoy monotherapy. The Opdivo+Yervoy regimen demonstrated a 58% reduction in the risk of disease progression versus Yervoy, while Opdivo monotherapy demonstrated a 43% risk reduction versus Yervoy monotherapy. The trial is ongoing and patients continue to be followed for overall survival, a co-primary endpoint.
    • Also at ASCO, the company announced results from an interim analysis of CA209-040, a Phase 1-2 dose-ranging trial evaluating the safety and anti-tumor activity of Opdivo in previously treated patients with hepatocellular carcinoma or advanced liver cancer. The estimated survival rate in evaluable patients receiving Opdivo was 62% at 12 months. Results also show the safety profile of Opdivo is generally consistent with that previously reported for Opdivo in other tumor types.
  • In April, the FDA accepted for filing and review an sBLA for Opdivo for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is August 27, 2015.

Yervoy

  • The company announced today that two Yervoy Phase 3 trials, Study -095 in metastatic castration-resistant prostate cancer and Study -156 in newly diagnosed extensive-stage disease small cell lung cancer, did not meet their primary endpoints of overall survival versus standard of care and have been discontinued. No new safety concerns with Yervoy were identified in either study. The company will complete a full evaluation of the data and work with investigators on the future publication of the results.
  • In July, the Japanese Ministry of Health, Labour and Welfare approved Yervoy for first- and second-line treatment of unresectable malignant melanoma.

Elotuzumab

  • In June, during ASCO and the European Hematology Association (EHA) meeting in Vienna, the company announced results from an interim analysis of ELOQUENT-2, a Phase 3, randomized, open-label trial that evaluated elotuzumab, an investigational immunostimulatory antibody, in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma. The study showed a 30% reduction in the risk of disease progression or death and a two-year PFS rate of 41% in the elotuzumab arm versus 27% in the control arm, respectively. Results also showed minimal incremental adverse events with the addition of elotuzumab to lenalidomide and dexamethasone. These results validate elotuzumab’s novel mechanism of action of directly activating the immune system in patients with relapsed or refractory multiple myeloma and were published in NEJM.
  • In June, at ASCO and EHA, the company also announced results from a randomized Phase 2 study that evaluated elotuzumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma which, consistent with ELOQUENT-2, demonstrated a 28% reduction in the risk of disease progression or death.

Eliquis

  • In June, at the International Society on Thrombosis and Haemostasis Congress in Toronto, the company, its partner Pfizer, and Portola Pharmaceuticals announced full results from the second part of ANNEXA™-A, a Phase 3, registration-enabling study evaluating the safety and efficacy of andexanet alfa, an investigational antidote and FDA-designated breakthrough therapy, administered as an intravenous bolus followed by a continuous two-hour infusion to sustain the reversal of anticoagulation activity of Eliquis in healthy volunteers ages 50-75 years. Andexanet alfa produced rapid reversal of the anticoagulant effect of Eliquis – as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion – and significantly reduced the level of free unbound Eliquis in the plasma and restored thrombin generation to normal.

HIV

  • In July, the FDA granted Breakthrough Therapy Designation to the investigational compound BMS-663068, a first-in-class HIV-1 attachment inhibitor, when used in combination with other antiretroviral agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.
  • In July, at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, the company announced additional Phase 2a proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir (± ritonavir) and support further development of the second-generation HIV-1 maturation inhibitor.

Reyataz

  • In June, the FDA granted pediatric exclusivity for Reyataz, providing an additional six-month period of exclusivity in the U.S.

Daklinza

  • In May, the FDA amended a previously granted Breakthrough Therapy Designation for the investigational combination of daclatasvir and sofosbuvir for use in hepatitis C (HCV) patients. The updated Designation reflects data from ALLY-1, a Phase 3 study of HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. The data were presented at The International Liver Congress in Vienna, Austria. Daclatasvir is marketed as Daklinza in Japan and the EU.

Evotaz

  • In July, the EC approved Evotaz tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. The approval allows for the marketing of Evotaz in all 28 Member States of the EU.

Nulojix

  • In May, during the American Transplant Congress in Philadelphia, the company presented results from a seven-year, long-term follow-up of BENEFIT, a prospective, randomized Phase 3 trial in kidney transplant patients. The study demonstrated a statistically significant 43% relative risk reduction of death or graft loss (transplant failure) in patients receiving the Nulojix FDA-approved dosing regimen over those receiving a cyclosporine regimen. There also was a statistically significant survival benefit of 52% relative risk reduction of death or graft loss at five years post-transplant among patients receiving the Nulojix regimen. In the long-term follow-up (years 3-7) on BENEFIT participants, the safety profile of the Nulojix regimen was similar to the cyclosporine regimen.

ANNEXA™ is a trademark of Portola Pharmaceuticals, Inc.

SECOND QUARTER BUSINESS DEVELOPMENT UPDATE

  • In July, the company and The Medical University of South Carolina announced a translational research collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis. The collaboration will include studies designed to improve the mechanistic understanding of fibrosis, explore patient segmentation based on disease characteristics and/or biomarker approaches and predictors of disease progression.

2015 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2015 GAAP EPS guidance range from $0.96 - $1.06 to $1.02 - $1.12. The company is also increasing its non-GAAP EPS guidance range from $1.60 - $1.70 to $1.70 - $1.80. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2015. Key revised 2015 non-GAAP line-item guidance assumptions include:

  • Worldwide revenues between $15.5 and $15.9 billion.
  • Full-year gross margin as a percentage of revenues of approximately 76%.
  • Advertising and promotion expense increasing in the high-single-digit range.
  • Marketing, sales and administrative expenses decreasing in the low- to mid-single-digit range.
  • Research and development expenses increasing in the mid-single-digit range.
  • An effective tax rate of approximately 19%.