07.21.14
Headquarters: New York, NY
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www.bms.com
TOP SELLING DRUGS
As the year 2013 drew to a close, Bristol-Myers Squibb’s fourth quarter was highlighted by the sale of its diabetes business to AstraZeneca, receiving $3.3 billion in closing and milestone payments during the quarter, and remaining eligible for royalty payments through 2025. The exit from metabolics is part of the company’s continued “Biopharma” strategy to transition to a specialty care model. As a result, BMS is down approximately 4,000 employees that were devoted to diabetes, most of which have been transferred to AZ.
For the year, revenues were down 7% to $16.4 billion, as top selling drug Abilify sales continue to plummet, down 19% to $2.3 billion. BMS’ cardiovascular franchise also continues to take a beating, with Avapro/Avalide and Plavix sales down 54% and 90%, respectively. While some heavy patent losses are behind them, top sellers Baraclude and Sustiva are waiting in the wings, with Reyataz not too far behind.
In the way of a bright spot, Orencia, Sprycel, and Yervoy, all boasting double-digit growth in 2013, are likely to continue to perform well for the company, as efforts to grow Eliquis revenue opportunities are pursued to recoup some cardiovascular losses.
The company achieved some important regulatory milestones in 1Q14 for Eliquis in the U.S., daclatasvir/asunaprevir in Japan, daclatasvir in Europe, and Farxiga in the U.S. BMS and its partner, Pfizer, have additional indications pending for Eliquis, including deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the risk reduction of recurrent DVT and PE.
Despite lower than expected revenues at launch and beyond, Eliquis has a better risk/benefit profile than its closest competitors (Pradaxa and warfarin) in preventing stroke. The companies anticipated a slow uptick, and they were right, but the drug is showing signs of recovery. For the year sales reached $146 million, and in 1Q14 were $106 million, up from just $22 million the previous year.
As far as acquisitions go, this year-to-date proved more conservative for BMS. In 1Q14, the company acquired iPierian, a privately held biopharma company focused on neurodegenerative diseases, for $175 million, with the potential for additional development and regulatory milestones totaling $550 million, as well as future royalties on sales. iPierian’s lead asset IPN007, a monoclonal antibody with a promising new approach to treat progressive supranuclear palsy (PSP) and other Tauopathies, is scheduled to enter Phase I trials by early 2015.
In R&D news, BMS and CytomX launched a $1.2 billion cancer collaboration under which BMS will use CytomX Therapeutics’ Probody drug discovery platform to develop new immunotherapies against multiple cancer targets. These therapies focus on selective activation within the cancer while sparing healthy tissue. This transaction ties into the company’s ultimate goals for its immuno-oncology assets.
Another, more recent immunotherapy pact with Incyte will investigate a combination regimen of nivolumab, BMS’ investigational PD-1 immune checkpoint inhibitor, and INCB24360 in multiple tumor types using an action that helps the immune system to restart and target and kill cancer cells. The company recently gained an FDA Breakthrough Therapy Designation for nivolumab for the treatment of patients with Hodgkin lymphoma (HL), based on data from a cohort of patients with HL in the company’s ongoing Phase Ib study of relapsed and refractory hematological malignancies.
Additionally, BMS and AbbVie landed a breakthrough label from the FDA for Elotuzumab in multiple myeloma, based on findings from a Phase II study that evaluated two dose levels of Elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated MM patients. The criterion for breakthrough designation requires preliminary clinical evidence that demonstrates substantial improvement on at least one endpoint over available therapies. The company’s recently submitted (April 2014) NDA for daclatasvir (DCV) and asunaprevir, also had received this notable designation prior to submission.
BMS will also use Five Prime Therapeutics’ target discovery platform for the development of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways.
While the company had a rather disappointing year financially, newer commercial stage products and a late-stage cancer therapy, nivolumab, are highly encouraging as potential growth drivers. The company is relying on—and devoting major resources to—its immuno-oncology assets, along with hepatitis C projects, which also brings much competition, for long-term growth prospects. With the company’s strong drug development reputation, many industry analysts are banking on its success.
twitter.com/bmsnews
www.bms.com
Headcount: | 24,000 | |
Year Established: | 1887 | |
Pharma Reveneus: | $16,385 | |
Total Revenues: | $16,385 | -7% |
Net Income: | $2,580 | 3% |
R&D Budget: | $3,731 | -4% |
TOP SELLING DRUGS
Drug | Indication | 2013 Sales | (+/- %) |
Abilify | schizophrenia | $2,289 | -19% |
Sustiva Franchise | HIV/AIDS | $1,614 | 6% |
Reyataz | HIV/AIDS | $1,551 | 2% |
Baraclude | hepatitis B | $1,527 | 10% |
Orencia | rheumatoid arthritis | $1,444 | 23% |
Sprycel | leukemia | $1,280 | 26% |
Yervoy | oncology | $960 | 36% |
Onglyza/Kombiglyze | diabetes | $877 | 24% |
As the year 2013 drew to a close, Bristol-Myers Squibb’s fourth quarter was highlighted by the sale of its diabetes business to AstraZeneca, receiving $3.3 billion in closing and milestone payments during the quarter, and remaining eligible for royalty payments through 2025. The exit from metabolics is part of the company’s continued “Biopharma” strategy to transition to a specialty care model. As a result, BMS is down approximately 4,000 employees that were devoted to diabetes, most of which have been transferred to AZ.
For the year, revenues were down 7% to $16.4 billion, as top selling drug Abilify sales continue to plummet, down 19% to $2.3 billion. BMS’ cardiovascular franchise also continues to take a beating, with Avapro/Avalide and Plavix sales down 54% and 90%, respectively. While some heavy patent losses are behind them, top sellers Baraclude and Sustiva are waiting in the wings, with Reyataz not too far behind.
In the way of a bright spot, Orencia, Sprycel, and Yervoy, all boasting double-digit growth in 2013, are likely to continue to perform well for the company, as efforts to grow Eliquis revenue opportunities are pursued to recoup some cardiovascular losses.
The company achieved some important regulatory milestones in 1Q14 for Eliquis in the U.S., daclatasvir/asunaprevir in Japan, daclatasvir in Europe, and Farxiga in the U.S. BMS and its partner, Pfizer, have additional indications pending for Eliquis, including deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the risk reduction of recurrent DVT and PE.
Despite lower than expected revenues at launch and beyond, Eliquis has a better risk/benefit profile than its closest competitors (Pradaxa and warfarin) in preventing stroke. The companies anticipated a slow uptick, and they were right, but the drug is showing signs of recovery. For the year sales reached $146 million, and in 1Q14 were $106 million, up from just $22 million the previous year.
As far as acquisitions go, this year-to-date proved more conservative for BMS. In 1Q14, the company acquired iPierian, a privately held biopharma company focused on neurodegenerative diseases, for $175 million, with the potential for additional development and regulatory milestones totaling $550 million, as well as future royalties on sales. iPierian’s lead asset IPN007, a monoclonal antibody with a promising new approach to treat progressive supranuclear palsy (PSP) and other Tauopathies, is scheduled to enter Phase I trials by early 2015.
In R&D news, BMS and CytomX launched a $1.2 billion cancer collaboration under which BMS will use CytomX Therapeutics’ Probody drug discovery platform to develop new immunotherapies against multiple cancer targets. These therapies focus on selective activation within the cancer while sparing healthy tissue. This transaction ties into the company’s ultimate goals for its immuno-oncology assets.
Another, more recent immunotherapy pact with Incyte will investigate a combination regimen of nivolumab, BMS’ investigational PD-1 immune checkpoint inhibitor, and INCB24360 in multiple tumor types using an action that helps the immune system to restart and target and kill cancer cells. The company recently gained an FDA Breakthrough Therapy Designation for nivolumab for the treatment of patients with Hodgkin lymphoma (HL), based on data from a cohort of patients with HL in the company’s ongoing Phase Ib study of relapsed and refractory hematological malignancies.
Additionally, BMS and AbbVie landed a breakthrough label from the FDA for Elotuzumab in multiple myeloma, based on findings from a Phase II study that evaluated two dose levels of Elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated MM patients. The criterion for breakthrough designation requires preliminary clinical evidence that demonstrates substantial improvement on at least one endpoint over available therapies. The company’s recently submitted (April 2014) NDA for daclatasvir (DCV) and asunaprevir, also had received this notable designation prior to submission.
BMS will also use Five Prime Therapeutics’ target discovery platform for the development of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways.
While the company had a rather disappointing year financially, newer commercial stage products and a late-stage cancer therapy, nivolumab, are highly encouraging as potential growth drivers. The company is relying on—and devoting major resources to—its immuno-oncology assets, along with hepatitis C projects, which also brings much competition, for long-term growth prospects. With the company’s strong drug development reputation, many industry analysts are banking on its success.