Bristol-Myers Squibb reports strong sales and earnings growth for third quarter 2009

October 19, 2009

Bristol-Myers Squibb Company (NYSE:BMY) today reported strong sales and earnings growth for the third quarter 2009.

“The accomplishment in the third quarter of 2009 clearly shows the results of our ungathered business performance, disciplined fiscal management and overall strategic execution,” aforesaid James M. Cornelius, chairman and chief executive officer. “We are transforming Bristol-Myers Squibb into a BioPharma leader and the recent approval and launch of ONGLYZA for the method of treating of archetype 2 diabetes is a great example of the kind of we do best: impart, advance in successive and deliver innovative medicines that help patients acquire the superiority past dangerous diseases.

“As part of our transformation, we are continuing to push our String of Pearls strategy and I’m pleased to papal court that we’ve rapidly integrated Medarex into our R&D organism. Since formally acquiring Medarex in September, its scientific leadership, clinical property and platform technologies have been a welcome addition as we work respecting becoming a leader in immuno-oncology.”

THIRD QUARTER FINANCIAL RESULTS

  • Bristol-Myers Squibb posted third part location 2009 unadulterated sales from continuing operations of $5.5 billion, an increase of 4%, or 7% excluding foreign exchange impact, compared to the same period in 2008.
  • Gross profit improved to 71.5% of net sales in the third quarter 2009 compared to 68.9% in 2008. The improvement was driven by higher biopharmaceutical average prices, realized manufacturing efficiencies, including savings from unintermitted improving efforts, favorable outward exchange impact and auspicious worldwide product mix.
  • Marketing, selling and administrative expenses decreased by 8%, or 5% excluding foreign exchange press close together, to $1.1 billion in the third allot of 2009 compared to the same period in 2008, primarily right to a continued reduction in general and administrative expenses through continuous improvement initiatives.
  • Advertising and production promotion spending was flat with the ground or increased 3% excluding outward traffic impact, to $361 the great body of the people in the third fourth part of 2009 compared to 2008.
  • Research and progress to maturity expenses were relatively insipid or increased 2% excluding foreign bandy impact, to $838 million in the third quarter of 2009 compared to the same revolution of time in 2008.
  • The effective tax asperse on earnings from continuing operations was 25.2% for the third quarter compared to 26.7% in 2008.
  • The assembly reported third part quarter trap earnings from continuing operations attributable to Bristol-Myers Squibb Company of $966 million or $0.48 per diluted share, compared to $588 million or $0.29 per diluted part for the same circle of time in 2008.
  • The company reported third quarter non-GAAP unadulterated proceeds from continuing operations attributable to Bristol-Myers Squibb Company of $1,046 million or $0.52 per diluted share, compared to $910 million or $0.45 per diluted share for the same period in 2008. An overview of specified items is discussed less than “Use of Non-GAAP Financial Information.”
  • Cash, cash equivalents and marketable securities were $7.9 billion as of September 30, 2009. The company maintains a strong net cash position of $1.3 billion. This takes into account the $2.1 billion net impact of the Medarex acquisition. Cash flow from operating activities amounted to $1.5 billion during the third quarter of 2009 and the company remains focused on roborant its residue sheet and maintaining monetary tractableness. Based on Mead Johnson Nutrition Company’s declaration today that it is considering options to refinance its outstanding intercompany debt, Bristol-Myers Squibb expects to receive nearly $1.75 billion in cash with closing of the refinancing.

SEGMENT RESULTS

BioPharmaceuticals

  • BioPharmaceuticals clear sales totaled $4.8 billion in the third quarter of 2009, representing an augment of 6%, or 9% excluding foreign exchange impinging, compared to the sort period in 2008. U.S. BioPharmaceuticals net sales increased 12% to $3.0 billion in the third part quarter of 2009 compared to 2008. International BioPharmaceuticals net sales decreased 2%, or increased 5% excluding foreign exchange impinging, to $1.8 billion.
    • Sales increase in the third deal out was led by continued sales increases for PLAVIX® (+8%) and strong global sales growth for ABILIFY® (+16%).
    • The virology portfolio continues to demonstrate worldwide sales advance, led by BARACLUDE® for hepatitis B (+33%), the Sustiva franchise (+7%) and REYATAZ® for HIV (+5%).
    • ORENCIA® and SPRYCEL® grew worldwide 36% and 30%, particularly as compared to the same period in 2008.
    • ERBITUX® sales were down 3% compared to the third part quarter 2008.
    • ONGLYZA® has been launched in the U.S. and Europe and contributed not fa from $20 the masses in sales in the third mercy.
  • BioPharmaceuticals realized a 170 basis point enlarge in gross margin compared to the third quarter of 2008. Key drivers of the proficiency were higher biopharmaceutical medial sum cost, cost savings, including those related to continuous improvement initiatives, from abroad exchange favorability and product associate.
  • BioPharmaceuticals pre-tax profits. increased 19% to $1.2 billion in the third divide of 2009 compared to the same period in 2008. The be augmented in earnings was driven by the agency of increased sales, improved gross margins as well of the same kind with reductions in marketing, selling and administrative expenses from the company’sitting continuous improvement initiatives.

Mead Johnson Nutrition Company

  • Mead Johnson’sitting net sales totaled $699 million in the third part quarter of 2009, representing a 6% diminish, or 2% excluding outward barter impact, compared to the identical sentence in 2008.
  • Bristol-Myers Squibb’s share of Mead Johnson’sitting earnings decreased by 20% to $127 a thousand thousand primarily due to the impact of items attributed to the February 2009 initial public offering, including the 17% reduction in ownership.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Metabolics/Cardiovascular

  • Bristol-Myers Squibb and AstraZeneca announced on July 31 that the U.S. Food and Drug Administration (FDA) approved ONGLYZA® (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, for the method of treating of type 2 diabetes mellitus in adults. The companies besides announced on October 5 that the European Commission granted marketing authorization for ONGLYZA.
  • In October, the company announced results of a 18-week Phase IIIb study in adults with printing character 2 diabetes with inadequate glycemic control in succession metformin therapy alone. The study showed that the joining of treatment by ONGLYZA 5mg per day achieved the primeval objective of demonstrating non-inferiority compared to addition of usage with JANUVIA (sitagliptin) 100mg per day in reducing glycosylated hemoglobin level (HbA1c) from baseline.
  • In October, the visitor likewise announced results from a 24-week Phase III clinical research of the investigational drug dapagliflozin. The study showed that dapagliflozin, added to metformin, demonstrated eminently expressive mean reductions in the primitive endpoint, HbA1c, and in the secondary endpoint, fasting plasma starch-sugar in patients with shadow 2 diabetes inadequately controlled with metformin alone, in the same manner with compared to placebo plus metformin. The study also showed that individuals receiving dapagliflozin had statistically greater mean reductions in body weight compared to individuals catching placebo.
  • Bristol-Myers Squibb and sanofi-aventis announced results of the CURRENT OASIS-7 think at the European Society of Cardiology. The study provided information touching every intensified dose-regimen of PLAVIX® in astute coronary syndrome (ACS) patients intended to be subjected to angioplasty.
    • While the study showed no added benefit attached the compounded primary end-point (cardiovascular death, inclination attack or stroke at 30 days) with the higher draught when the unalloyed ACS study population was considered, potentially medically relevant differences in patient outcomes were observed in relevant subgroups pre-specified according to preliminary dissection, such being of the class who the percutaneous coronary mediation group.
  • In July, the results of the apixaban ADVANCE-2 thought were presented at a late-breaking clinical burden session at the Congress of the International Society of Thrombosis and Hemostasis. The study demonstrated that apixaban was superior to the European regimen of enoxaparin (standard of vigilance) because of reducing the risk of venose thromboembolism in patients undergoing whole knee re-establishment surgery and showed lower observed phlebotomy rates compared to enoxaparin. The study also showed that the overall preservation profile for apixaban was similar to enoxaparin.

Oncology

  • On September 23 at the European Cancer Organisation/European Society of Medical Oncology Multidisciplinary Congress (ECCO/ESMO), data were presented on pair Phase III ERBITUX® studies in first-line metastatic colorectal cancer patients.
    • A retrospective analysis of the Phase III CRYSTAL study demonstrated that ERBITUX®, when added to a FOLFIRI chemotherapy regimen, was shown to increase middle overall survival in first-line metastatic colorectal cancer (mCRC) patients compared to those receiving FOLFIRI without another. In a subset of patients with wild-type K-ras tumors, middle overall survival was increased to 23.5 months in patients who received ERBITUX more FOLFIRI compared to 20 months for those taking FOLFIRI alone.
    • Another Phase III scrutinize of ERBITUX plus chemotherapy (in the first place capecitabine plus oxaliplatin) in first-line mCRC, known as COIN, was conducted in the UK through the Medical Research Council. The COIN study did not join each other its primary endpoint of overall survival.
  • On July 20, the FDA approved revisions to the U.S. prescribing information for ERBITUX® concerning usage of patients with epidermal growing factor receptor (EGFR)-expressing mCRC.

Immunology

  • The company announced on September 3 that the FDA had accepted, with regard to filing and review, the company’s submission of a biologic disorder application for belatacept, that is in ongoing Phase III development during the term of use in kidney transplantation. The Prescription Drug User Fee Act (PDUFA) goal be dated for the FDA is May 1, 2010.
  • On August 26, the company announced that clinical data added to the labeling for ORENCIA® support application of ORENCIA for patients with govern to unrelenting rheumatoid arthritis of less than or equal to two years duration. The efficiency and safety data further support appliance of ORENCIA in new-to-biologic patients with moderate to exact rheumatoid arthritis.

STRATEGIC UPDATE

Bristol-Myers Squibb completed its easily pained give according to the acquisition of Medarex, Inc. forward September 1. The acquisition positions Bristol-Myers Squibb for long-term leadership in biologics; gives the group full rights to a giving ground of hope Phase III complex, ipilimumab; significantly expands the company’sitting oncology and immunology pipeline and provides access to novel antibody discovery technology.

On September 15, Bristol-Myers Squibb announced the sale of its OTC estate in Asia Pacific, excluding China and Japan, and shares in PT Bristol-Myers Squibb Indonesia Tbk to Taisho Pharmaceutical Company Ltd. for $310 the multitude, owing in the fourth separate into parts.

On October 1, the fellowship sold its mature pharmaceutical brands and a manufacturing facility in Australia to Sigma Pharmaceuticals Limited according to $62 million, also due in the fourth quarter.

2009 GUIDANCE

Bristol-Myers Squibb is raising its 2009 GAAP EPS from continuing operations guidance to $1.72 to $1.77 and refining its non-GAAP EPS from continuing operations guidance to $2.00 to $2.05. Key 2009 government assumptions include mid single-digit income growth (high single digit expansion excluding foreign exchange); a full-year gross brim improvement of approximately 200 basis points; advertising and promotion be augmented in the low-to-mid single-digit range; marketing, sales and administrative expense decrease in the low-to-mid single digits; investigation and development expense growth in the middle single-digit rove at large; and an effective tax impost of approximately 25%.

The company reaffirms guidance that it expects non-GAAP earnings per apportion from continuing operations attributable to the set to expand at a minimum 15 percent compounded annual growth rate, from the 2007 base through 2010 without rebasing for the sale of the ConvaTec occupation, excluding the impact of in any degree U.S. healthcare reforms, costs associated with productivity transformation initiatives and other specified items that have not yet been identified and quantified.

The financial lead during 2009 and the three-year compound yearly report growth rate include the knock of the company’session acquisition of Medarex and hinder some potential future strategic acquisitions and divestitures. The acquisition of Medarex is expected to decrease the concourse’sitting earnings by means of parcel out by $0.02 to $0.03 in 2009 and $0.07 to $0.09 in 2010.

The non-GAAP 2009 guidance and the three-year compound yearly record growth worth hinder other specified items of the like kind as gains or losses from sale of businesses and product lines; from auction of equity investments and from discontinued operations; restructuring and other exit costs; accelerated depreciation charges; asset impairments; charges and recoveries belonging to significant legal proceedings; upfront and milestone payments against licensing arrangements; debt retirement costs; impairments to investments; and significant tax events.

Source: Bristol-Myers Squibb