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Bristol-Myers Squibb Company (NYSE: BMY) today reported results for the second quarter of 2013 highlighted by the resubmission of
Forxiga in the U.S., the completion of regulatory filings for
Eliquis and Metreleptin in the U.S., and the presentation of important data from its immuno-oncology franchise at ASCO, for
Orencia® at EULAR and for
Eliquis at ISTH. In addition, the company adjusted GAAP EPS and non-GAAP EPS guidance for 2013.
“In the second quarter, the strength in the performance of some of our key products, the important data we presented across our portfolio and the key regulatory filings we made in the U.S. strengthen our confidence as we build a solid foundation for future growth,” said
Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “We will continue to invest the necessary resources across our portfolio to grow existing brands, support the execution of new launches and deliver a diverse and sustainable pipeline,” Andreotti said.
$ amounts in millions, except per share amounts
GAAP Diluted EPS
Non-GAAP Diluted EPS
SECOND QUARTER FINANCIAL RESULTS
Bristol-Myers Squibb posted second quarter 2013 net sales of $4.0 billion, a decrease of 9% compared to the same period a year ago, following the U.S. patent expiration of Avapro®/Avalide®in March 2012 and Plavix® in May 2012. Excluding Plavix and Avapro/Avalide, net sales grew by 10% compared to the second quarter of 2012.
U.S. net sales decreased 22% to $2.0 billion in the quarter compared to the same period a year ago. International net sales increased 10% to $2.0 billion.
Gross margin as a percentage of net sales was 72.6% in the quarter compared to 72.0% in the same period a year ago.
Marketing, selling and administrative expenses increased 4% to $1.0 billion in the quarter.
Advertising and product promotion spending decreased 3% to $218 million in the quarter.
Research and development expenses decreased 1% to $951 million in the quarter.
The effective tax rate on earnings before income taxes was 0% in the quarter, compared to 23.7% in the second quarter last year. Income taxes in the current quarter reflect a more favorable earnings mix between high and low tax jurisdictions, primarily driven by specified items.
The company reported net earnings attributable to Bristol-Myers Squibb of $536 million, or $0.32 per share, in the quarter compared to $645 million, or $0.38 per share, a year ago.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $730 million, or $0.44 per share, in the second quarter, compared to $808 million, or $0.48 per share, for the same period in 2012. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
Cash, cash equivalents and marketable securities were $6.0 billion, with a net debt position of $1.2 billion, as of June 30, 2013.
SECOND QUARTER PRODUCT AND PIPELINE UPDATE
Bristol-Myers Squibb’s global sales in the second quarter included
Yervoy®, which grew 44%,
Onglyza®/Kombiglyze™ , which grew 40%,
Sprycel®, which grew 28%, and
Orencia, which grew 21%.
In June, Japan’s Ministry of Health, Labour and Welfare approved the subcutaneous formulation of Orencia for the treatment of rheumatoid arthritis in cases where existing treatments are inadequate. The company co-develops and co-commercializes Orencia in Japan with Ono Pharmaceutical Co., Ltd.
In June, at the European League Against Rheumatism annual congress in Madrid, the company presented year two data from the head-to-head AMPLE study that showed the subcutaneous formulation of Orencia achieved comparable rates of efficacy and similar onset of response versus Humira® among biologic-naïve patients with moderate to severe rheumatoid arthritis. Overall safety data were similar for both groups while discontinuations due to adverse events were higher for Humira.
In July, the U.S. Food and Drug Administration (FDA) accepted for review the Supplemental New Drug Application for Eliquis, for the prevention of deep vein thrombosis following hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) date—the date by which a decision by the FDA is expected—is March 15, 2014.
In June, the company and its partner, Pfizer, announced that results from the Phase III AMPLIFY trial, which evaluated Eliquis versus the current standard of care for the treatment of acute venous thromboembolism, were published online by the New England Journal of Medicine and presented at the International Society on Thrombosis and Haemostasis congress in Amsterdam. The results showed that Eliquis demonstrated comparable efficacy and significantly lower rates of major bleeding compared to the current standard of care.
In May, the company and its partner, Pfizer, announced that results from a prespecified subanalysis of the ARISTOTLE trial were published in Circulation, a peer-reviewed journal of the American Heart Association. The trends across the subgroup analysis were consistent with the overall study results that demonstrated Eliquis’ superiority versus warfarin in the reduction of stroke or systemic embolism and the number of major bleeding events and mortality in patients with nonvalvular atrial fibrillation.
The company and its partner AstraZeneca resubmitted to the FDA the New Drug Application for Forxiga for the treatment of adults with type 2 diabetes. The resubmission, which is pending acceptance by the FDA, includes several new studies and additional long-term data (up to four years’ duration) from previously submitted studies.
In June, at the American Diabetes Association scientific sessions in Chicago, the company and its partner, AstraZeneca, presented results from a two-week Phase IIa pilot study evaluating Forxiga added to insulin in 70 adult patients with sub-optimally controlled type 1 diabetes that showed that mean daily blood glucose derived from 7-point glucose measurements trended downward in all treatment groups through day seven and that reductions in total daily insulin dosing at day seven were observed with Forxiga.
In June, the company and its partner, AstraZeneca, announced top-line results from the Phase IV SAVOR-TIMI-53 trial in adult patients with type 2 diabetes and either a history of established cardiovascular disease or multiple risk factors that showed Onglyza met its primary safety objective of non-inferiority and did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke, versus placebo when added to the current standard of care. The results will be presented at the European Society of Cardiology meeting in September.
In June, the FDA accepted the filing and granted a Priority Review designation, for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy, a rare disease estimated to affect a few thousand people around the world, often with an early age of onset. In July, the FDA notified the company and its partner, AstraZeneca, that it will require a three-month extension to complete its review of the data supporting the application. The PDUFA date is February 27, 2014.
In June, at the annual meeting of the American Society of Clinical Oncology in Chicago, the company announced the results from a dose-ranging Phase I trial evaluating the safety and anti-tumor activity of nivolumab combined either concurrently or sequentially with Yervoy in patients with advanced melanoma. In patients who received the 1 mg/kg nivolumab + 3 mg/kg Yervoy doses in the concurrent regimen, 53% (n= 9 of 17) had confirmed objective responses based on modified World Health Organization criteria. In all nine of the responders, tumors shrank by at least 80% by the time of the first scheduled clinical treatment assessment (12 weeks), including three complete responses. The data were also published in the New England Journal of Medicine.
In June, at the European Hematology Association annual congress in Stockholm, the company and its partner, AbbVie, presented updated efficacy and safety data from a small, randomized, Phase II open-label study of patients with previously-treated multiple myeloma that demonstrated median progression-free survival of 33 months and an objective response rate of 92% among patients treated with the investigational monoclonal antibody elotuzumab 10 mg/kg in combination with lenalidomide and low-dose dexamethasone.
SECOND QUARTER BUSINESS DEVELOPMENT UPDATE
In June, the company and Simcere Pharmaceutical Group announced the companies agreed to collaborate in China on the development and commercialization of the subcutaneous formulation of Orencia for the treatment of rheumatoid arthritis.
2013 FINANCIAL GUIDANCE
Bristol-Myers Squibb is adjusting its 2013 GAAP EPS guidance range to $1.41 to $1.49, from $1.54 to $1.64, and its non-GAAP EPS guidance range to $1.70 to $1.78, from $1.78 to $1.88. Both GAAP and non-GAAP guidance assume current exchange rates. Key 2013 non-GAAP guidance assumptions include:
Worldwide sales between $16.0 billion and $16.5 billion.
Full-year gross margin as a percentage of sales of approximately 73%.
Advertising and promotion expense increasing in the mid-single digit range.
Marketing, sales and administrative expenses remaining flat versus last year.
Research and development expenses growing in the low-single-digit range.
An effective tax rate of approximately 15%.
The financial guidance for 2013 excludes the impact of any potential strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2013 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.