Bristol-Myers Squibb Company (NYSE: BMY) today announced first quarter results that included strong sales and earnings growth, and several key R&D milestones—most notably U.S. regulatory approval for YERVOY. The company also confirmed guidance for the year.
"The strength of our financial and R&D performance in the first quarter confirms our ability to execute our focused BioPharma strategy and helps position us for long-term success," said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb.
"Our string of achievements in the quarter is a good start to an exciting year in which we are anticipating several key regulatory decisions and the presentation of important data across our portfolio. We delivered solid financial performance at both the top and bottom lines, received regulatory approval for YERVOY in the U.S., received a positive advisory opinion from European regulatory authorities for both ELIQUIS and NULOJIX, and presented promising data on our investigational hepatitis C portfolio at the annual meeting of the European Association for the Study of the Liver," Andreotti said.
FIRST QUARTER FINANCIAL RESULTS
- Bristol-Myers Squibb posted first quarter 2011 net sales of $5.0 billion.
- U.S. net sales increased 5% to $3.3 billion in the first quarter of 2011 compared to the same period in 2010. International net sales increased 3%, or 1% excluding foreign exchange impact, to $1.8 billion.
- Gross margin as a percentage of net sales was 73.2% in the first quarter of 2011 compared to 72.8% in the same period in 2010.
- Marketing, selling and administrative expenses increased 3% to $928 million in the first quarter of 2011.
- Advertising and product promotion spending increased 1% to $214 million in the first quarter of 2011.
- Research and development expenses increased 3% to $935 million in the first quarter of 2011.
- The effective tax rate on earnings before income taxes was 22.6% on a GAAP basis in the first quarter of 2011, compared to 24.2% in the same period in 2010.
- The Company reported GAAP net earnings attributable to Bristol-Myers Squibb of $986 million, or $0.57 per share, in the first quarter of 2011 compared to $743 million or $0.43 per share for the same period in 2010.
- The Company reported non-GAAP net earnings of $1.0 billion, or $0.58 per share, in the first quarter of 2011 compared to $967 million, or $0.56 per share, for the same period in 2010. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
- The incremental impact of the two additional U.S. health care reform provisions for new discounts associated with the Medicare Part D coverage gap and an annual pharmaceutical company fee decreased first quarter EPS by approximately $0.03 on both a GAAP and non-GAAP basis.
- Cash, cash equivalents and marketable securities were $9.9 billion, with a net cash position of $4.4 billion as of March 31, 2011.
FIRST QUARTER PRODUCT AND PIPELINE UPDATE
- Bristol-Myers Squibb's global sales growth in the first quarter was led by PLAVIX® (6%), recently launched ONGLYZA® and KOMBIGLYZE™, BARACLUDE® (27%), SPRYCEL® (31%) and ORENCIA® (18%).
- In March, the U.S. Food and Drug Administration (FDA) approved YERVOY for the treatment of patients with newly diagnosed or previously-treated unresectable (inoperable) or metastatic melanoma. YERVOY became commercially available in the U.S. in early April.
- In March, the Company announced that a Phase III clinical trial of YERVOY—known as study 024—met its primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma. An abstract of the 024 data was submitted to the American Society of Clinical Oncology for potential presentation at its Annual Meeting in June.
- In February, the Company and its partner, Pfizer, announced that AVERROES data demonstrating that the investigational agent ELIQUIS was superior to aspirin in reducing stroke or systemic embolism in patients with atrial fibrillation unsuitable for warfarin was published in The New England Journal of Medicine. Preliminary results of AVERROES were first presented in August 2010 at the European Society of Cardiology annual meeting in Stockholm. Full results were presented at the International Stroke Conference in February 2011 in Los Angeles.
- In March, the Marketing Authorization Application (MAA) for ELIQUIS received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for use in the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery. The CHMP's positive opinion will now be reviewed by the European Commission, which has authority to approve medicines for the European Union.
- In April, the MAA for NULOJIX received a positive opinion from the CHMP for use in adult patients receiving kidney transplants. The positive opinion is subject to review by the European Commission.
- In March, the FDA accepted for review the New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes. The Prescription Drug User Fee Act (PDUFA) date—the date by which action from the FDA is expected—is October 28, 2011. The company develops dapagliflozin with its partner AstraZeneca.
- In January, the FDA granted an additional six-month period of exclusivity to market PLAVIX. Exclusivity for PLAVIX is now scheduled to expire May 17, 2012. The Company develops and commercializes PLAVIX with its partner sanofi-aventis.
- In February, the Company and its partner, AstraZeneca, announced that the FDA approved a labeling update for ONGLYZA to include data from two clinical studies. The U.S. label update provides more evidence regarding the use of ONGLYZA in renally impaired adults with type 2 diabetes, and more information on the comparison between glipizide and ONGLYZA in patients also taking metformin. Data from the renal study also led to approval by the European Commission for the use of ONGLYZA in treating people with type 2 diabetes who have moderate or severe renal impairment.
- In February, the FDA approved ABILIFY as an adjunct to mood stabilizers lithium or valproate for the maintenance treatment of Bipolar I Disorder. European approval for this use was received in January. The Company develops and commercializes ABILIFY with its partner Otsuka.
- In March, the European Commission approved BARACLUDE for the treatment of hepatitis B in adult patients with decompensated liver disease.
- In February, the Company and its partner, Eli Lilly, stopped enrollment in one of two Phase III studies evaluating necitumumab as a first-line treatment for advanced nonsquamous non-small cell lung cancer, based on recommendations from an independent Data Monitoring Committee (DMC). Necitumumab continues to be studied in a Phase III trial evaluating its potential as a treatment for a different type of lung cancer called squamous non-small cell lung cancer, based on recommendations from the same DMC.
Investigational Hepatitis C (HCV) Portfolio
- In March, at the International Liver Congress, the annual meeting of the European Association for the Study of the Liver (EASL), the Company presented data on investigational compounds in HCV, including: BMS-790052, a direct acting antiviral NS5A replication complex inhibitor; and PEG-Interferon lambda.
BUSINESS DEVELOPMENT UPDATE
In March, the Company and WuXi PharmaTech announced a partnership under which WuXi will build, equip and operate a dedicated fully cGMP-compliant 25,000-square-foot analytical testing facility in Shanghai to store and test stability samples of small-molecule new chemical entities to support global marketing applications.
2011 FINANCIAL GUIDANCE
Bristol-Myers Squibb is confirming its 2011 GAAP EPS guidance range from $2.00 to $2.10 and its non-GAAP EPS range from $2.10 to $2.20. Key 2011 non-GAAP guidance assumptions remain unchanged. The non-GAAP guidance excludes 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.
The financial guidance for 2011 excludes the impact of any potential strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified.
Bristol-Myers Squibb Company