The FINANCIAL — Bristol-Myers Squibb Company on April 28 reported results for the first quarter of 2015, which were highlighted by strong global sales for key brands, important regulatory and clinical milestones in immuno-oncology (I-O) and across the company’s portfolio, and the completion of several strategic transactions that will advance the company’s leadership in I-O and strengthen its pipeline in cardiovascular and genetically defined diseases.
“We have started the year off with strong sales among new and inline brands, including Yervoy, Eliquis, our hepatitis C franchise and Opdivo, and brought important new medicines to patients with cancer and HIV,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “We continued to advance our pipeline with key regulatory and clinical progress across our portfolio and invested in several important business development opportunities that will help strengthen our future portfolio.”
FIRST QUARTER FINANCIAL RESULTS
Bristol-Myers Squibb posted first quarter 2015 revenues of $4.0 billion, an increase of 6% compared to the same period a year ago. Excluding the divested Diabetes Alliance, global revenues increased 10% or 17% adjusted for foreign exchange impact.
U.S. revenues increased 16% to $2.0 billion in the quarter compared to the same period a year ago. International revenues decreased 2% to $2.0 billion.
Gross margin as a percentage of revenues was 79.0% in the quarter compared to 74.6% in the same period a year ago.
Marketing, selling and administrative expenses decreased 7% to $894 million in the quarter.
Advertising and product promotion spending decreased 17% to $135 million in the quarter.
Research and development expenses increased 7% to $1.0 billion in the quarter.
The effective tax rate was 17.2% in the quarter, compared to 5.0% in the first quarter last year. Income taxes in 2014 included tax benefits attributed to the diabetes divestiture.
The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.71 per share, in the quarter compared to $937 million, or $0.56 per share, a year ago.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.71 per share, in the first quarter, compared to $766 million, or $0.46 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 $11.9 billion, with a net cash position of $4.4 billion, as of March 31, 2015.
FIRST QUARTER PRODUCT AND PIPELINE UPDATE
Bristol-Myers Squibb’s global sales in the first quarter included Eliquis, which grew by $249 million, Yervoy, which grew 20%, Orencia and Sprycel, which grew 10% each, Daklinza and Sunvepra, which had combined sales of $264 million, and Opdivo, which had sales of $40 million.
In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending that Opdivo be granted approval for use in both first-line and previously treated patients with advanced (unresectable or metastatic) melanoma. This is the first positive opinion given by the CHMP for a PD-1 immune checkpoint inhibitor, and it will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
In April, at the American Association for Cancer Research meeting in Philadelphia, the company announced positive results from CheckMate -069, a Phase 2 trial evaluating a regimen of Opdivo+Yervoy versus Yervoy alone in patients with previously untreated advanced melanoma. Patients with BRAF wild-type mutation status treated with the Opdivo+Yervoy regimen experienced a higher objective response rate (ORR) of 61% (n=44/72) – the primary study endpoint – compared to 11% (n=4/37) for patients administered Yervoy monotherapy (P<0.001). Complete responses were also reported in 22% (n=16) of patients with BRAF wild-type mutation status administered the Opdivo+Yervoy regimen and in no patients who received Yervoy monotherapy. Similar results were also observed in BRAF mutation-positive patients. The results were published in The New England Journal of Medicine, according to Bristol-Myers Squibb.
In April, the company announced that an open-label, randomized Phase 3 study evaluating Opdivo versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) 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.
In March, the FDA approved Opdivo for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy. Opdivo is the first and only PD-1 therapy to demonstrate overall survival in previously treated metastatic squamous NSCLC.
In April, the CHMP adopted a positive opinion approving the ClickJect Pre-Filled Pen, a new autoinjector delivery device for Orencia for use in adult patients in the E.U. who have moderate to severe active rheumatoid arthritis in combination with methotrexate after inadequate disease-modifying anti-rheumatic drug (DMARD) response.
In March, the FDA accepted for filing and review the sBLA for Yervoy for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection. The projected FDA action date is October 28, 2015.
In April, the company announced that primary endpoints were successfully met in ALLY-1, a Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV. The data was presented as a late-breaker at the European Association for the Study of the Liver annual meeting in Vienna. Daclatasvir is marketed as Daklinza in the E.U. and Japan.
In March, the FDA accepted the company’s resubmitted New Drug Application (NDA) to use daclatasvir in combination with sofosbuvir to treat chronic HCV genotype 3. The original NDA was amended to include data from ALLY-3, a Phase 3 trial that showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher (96%) in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will review the submission within a six-month timeframe.
In February, the company announced results from ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic HCV coinfected with HIV. Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase.
In January, the FDA approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
In February, at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, the company announced data supporting further clinical development of BMS-955176, an investigational compound designed to prevent the maturation of HIV-1. The Phase 2a study findings confirm the antiretroviral activity of BMS-955176 as an HIV-1 maturation inhibitor.
In February, also at CROI, the company announced data from a Phase 2b trial of BMS-663068, an investigational compound designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study comparing BMS-663068 to Reyataz and ritonavir, virologic response rates (HIV-1 RNA <50 c/mL) and immunologic reconstitution were similar across both arms of the trial through 48 weeks.
Based on the positive results of the Phase 2b trial, a Phase 3 clinical trial of the attachment inhibitor in heavily treatment-experienced patients began in February 2015.
In April, the company announced an agreement with Lilly to transfer rights to Erbitux in North America, including the U.S., Canada, and Puerto Rico, from Bristol-Myers Squibb to Lilly. Rights include, but are not limited to, full commercialization and manufacturing operational responsibilities.
FIRST QUARTER BUSINESS DEVELOPMENT UPDATE
In April, the company completed its acquisition of Flexus Biosciences, Inc., a privately held biotechnology company focused on discovering and developing novel anti-cancer therapeutics. The transaction, which was announced in February, includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries.
In April, the company announced an agreement with uniQure N.V. that provides Bristol-Myers Squibb with exclusive access to uniQure’s gene therapy technology platform for multiple targets in cardiovascular diseases. The collaboration includes uniQure’s proprietary gene therapy program for congestive heart failure that is intended to restore the heart’s ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction. Beyond cardiovascular diseases, the agreement also includes the potential for target-exclusive collaboration in other disease areas. In total, the companies may collaborate on 10 targets, including S100A1.
In March, the company acquired an exclusive global license to Novo Nordisk’s discovery biologics research program focused on modulating the innate immune system as a therapy for autoimmune diseases.
In March, the company acquired an exclusive option to license and commercialize PROSTVAC®, Bavarian Nordic’s investigational Phase 3 prostate-specific antigen-targeting cancer immunotherapy in development for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
In February, the company announced an agreement with Rigel Pharmaceuticals, Inc. for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Opdivo and Yervoy.
PROSTVAC is a registered trademark of BN Immunotherapeutics, Inc.