07.12.06
#9. Bristol-Myers Squibb
345 Park Avenue
New York, NY 10154-0037
Tel: (212) 546-4000
Fax: (212) 546-4020
www.bms.com
Headcount | 43,000 | |
Year Established | 1887 | |
PharmA Revenues | $15,254 | -2% |
Total Revenues | $19,207 | -1% |
Net Income | $3,000 | +26% |
R&D Budget | $2,746 | +10% |
Drugs Approved/Launched | |
Drug | Indication |
baraclude | chronic hepatitis B virus |
sprycel | chronic myelogenous leukemia |
orencia | rheumatoid arthritis |
EMSAM | transdermal for major depressive disorder |
erbitux | head and neck cancer |
Drugs Pending approval | |
Drug | Indication |
sustiva/truvada combo* | single tablet regimen HIV/AIDS |
plavix | acute ST-segment elevation myocardial infarction (STEMI) |
* Truvada is a product of Gilead Sciences |
Drugs in Phase IIb and Beyond | |
Drug | Indication |
ixabepilone | taxane-resistant breast cancer, solid tumors |
ipilimumab | metastatic melanoma |
vinflunine | bladder, non-small cell lung, breast cancers |
belatacept | prevention of organ transplant rejection |
saxagliptin | type 2 diabetes |
“In total, the company has eight drugs in late-stage development: four cancer drugs, two drugs in development for diabetes, one for rheumatoid arthritis and one for solid organ transplant rejection.”
Early Research Projects
“The company has 29 compounds in early development; eight in oncology, 10 in cardiovascular and metabolic diseases, one in neuroscience, five in virology and five in immunology.”
Top Selling Drugs | |||
Drug | Indication | Sales | (+/- %) |
plavix | platelet inhibitor | $3,825 | 15% |
pravachol | cholesterol | $2,256 | -14% |
avapro | hypertension | $982 | 6% |
abilify | schizophrenia | $912 | 54% |
taxol | oncology | $747 | -25% |
reyataz | HIV/AIDS | $696 | 68% |
sustiva | HIV/AIDS | $680 | 10% |
Account for 66% of total pharma sales, up from 61% in 2004.
PROFILE
The past year has brought some disappointment with the loss of exclusivity for one of Bristol-Myers Squibb’s top selling drugs, Pravachol, and a failed venture with Merck, as well as some promise with a growing pipeline and a significant approval in Orencia. Also, much to the relief of BMS and Sanofi-Aventis (SA), the two companies have bought themselves some time regarding the Plavix patent.
THE LOWE DOWN Here’s a comparison that I’ll bet hasn’t been made before: Bristol-Myers Squibb reminds me of the old Ottoman Empire. No matter how much room they take up, a lot of people don’t give them the respect that they might deserve. And somehow it always seems as if they should be a bit more powerful than they are, given their size. It’s not like they aren’t trying. Actually, sometimes they might even be trying too hard: the company has a reputation of overpaying for some of their outside deals (ImClone, Dupont’s pharma portfolio). But some of their big chances in recent years haven’t quite worked out. Their statin entry got beaten up severely when they took on Lipitor, for example, and a shot at a new diabetic compound ended disastrously (see Merck). But that statin (pravachol) still sells $2 billion a year, and a lot of other companies would eat their Erlenmeyers if they thought it would give them something that did that well. I have to say this for BMS: they’ve been through some awful clinical failures and patent expirations, and they’re still in there pitching. If they come back strong in oncology, they’ll be a force to reckon with. The Ottomans would be envious. — Derek Lowe |
Prior to the settlement with Apotex, the outlook for BMS was grim, considering Plavix and cholesterol reducer Pravachol are the company’s blockbuster drugs, accounting for 20% and 12% of BMS’s sales, respectively. Revenues will slide over the next few years for these two drugs, but double-digit growth of newer products will help ease these losses.
Setbacks
Several significant and costly ventures failed for BMS in 2005, including its $100 million diabetes partnership with Merck for Pargluva. The FDA did not approve the drug, citing cardiovascular side effects. Also, the company discontinued development of muraglitazar, an investigational type 2 diabetes drug, due to its questionable CV safety profile.
But BMS is going full steam ahead in the Pharma industry, divesting itself of non-core properties. As part of the company’s strategic focus on developing its pipeline, BMS recently sold two of its businesses. In May 2005, it sold off the Oncology Therapeutics Network distribution business for $197 million and later sold its U.S. and Canadian Consumer Medicines business to Novartis for $660 million.
Big Plans for Small Targets
BMS has a major focus on biologics, with new products and expanded facilities. Some biologics in the company’s pipeline include belatacept (renal transplantation) and ipilimumab (prostate cancer), which is being developed by BMS and Medarex.
In June 2005 BMS completed an agreement with Celltrion to manufacture biologic products in Celltrion’s facility in South Korea, which is capable of producing multiple products, including Orencia and belatacept. This agreement adds to BMS’s existing biologic manufacturing capacity, which includes a facility in Syracuse, NY and a biologics manufacturing agreement with Lonza.
In June 2006, BMS announced plans to build a new large-scale multi-product bulk biologics manufacturing facility in Devens, MA. The new facility would support increased production capacity for commercially available biologic compounds such as Orencia, and biologic compounds in development. The company will spend as much $660 million for the construction of the facility. Also, BMS recently announced plans to invest $200 million to expand its Manati, PR facility for the filling and finishing of its sterile products and biologic compounds.
Productive Pipeline
BMS is putting its best R&D foot forward. Faced with several recent failures and increasing generic pressure, the company has been investing heavily in its pipeline.
This R&D push may be paying off. BMS gained approval of six new molecular entities since November 2002, an enviable rate of success. Two more compounds recently advanced to Phase III development, and Spycel, a promising cancer drug for chronic myelogenous leukemia (CML), just gained approval. If BMS can establish Sprycel as a front-line treatment for CML, it may rival Novartis’ Gleevec, which has more than $2 billion in annual sales.
BMS site in Lawrenceville, NJ |
The company’s big approval in the past year was Orencia, a biologic for treatment of rheumatoid arthritis. BMS also gained approval for Baraclude (chronic hepatitis B virus) and EMSAM, the first transdermal patch for treatment of major depressive disorder.
Alliances have also added to potential candidates in BMS’s pipeline. BMS and Domantis are collaborating to discover and develop bio-therapeutics for uses in the fields of immunology and oncology. The company also entered an agreement with Exelixis to develop therapies targeted against the Liver X Receptor (LXR), to treat cardiovascular and metabolic disorders.
R&D expenditures in 2005 topped out at $2.7 billion, up 10%, which included $2.5 billion in milestone payments for in-licensing and development programs. For 1Q2006, $750 million was spent on R&D, up 22%.
If 1Q2006 is an indication of a trend onwards and upwards for the company, 2006 will be more profitable. BMS reported a 34% increase in first-quarter profit to $714 million, helped by higher sales of heart and blood-pressure drugs and, a $200 million gain from selling off assets to psoriasis drug, Dovonex. However, revenues were up only 3% to $4.7 billion, (U.S. pharma revenues rose 17% to $2.1 billion). Erbitux sales were $413 million for the year up 58%. Plavix, Abilify, and Reyataz sales were up 15%, 54% and 68% respectively—definitely a bright spot for the company.
BMS has some work to do in the months and years ahead as it tries to replace those products that face generic competition. Provided the Plavix patent holds up, the company’s biologic-based R&D push could do the trick, creating a key growth driver for BMS in the coming years.
--Kristin Brooks
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