07.14.15
Headquarters: New York, NY
twitter.com/bmsnews
www.bms.com
TOP SELLING DRUGS
For nearly a decade, through acquisitions, divestitures and organic growth, Bristol-Myers Squibb has transformed itself into a highly specialized biopharma company. Five years ago about 40% of its pipeline consisted of biologics and three to five years from now, the company expects that number will grow to about 75%.
As BMS’ biologics portfolio continues to grow, so has its capability to develop and manufacture its products. This past year the company nearly doubled the size of its manufacturing complex in Devens, MA, investing $1 billion and bringing the employee count to 750. BMS is also building a new, large-scale biologics manufacturing facility in Dublin, Ireland to produce a portfolio of approved and investigational biologics covering oncology, virology and immunoscience. This venture will create as many as 400 manufacturing jobs and once completed in 2019, will significantly expand BMS’ biologics manufacturing capacity and play a central role in its global manufacturing network. The cost is expected to match that of the Devens investment.
Charged with carrying these efforts forward, BMS named a new CEO, Giovanni Caforio, M.D. As of May 5, he replaced Lamberto Andreotti who will serve as chairman after his retirement on August 3. Dr. Caforio helped build the company’s immuno-oncology portfolio as chief commercial and chief operating officer, and was integral in shaping the company’s transformation to a specialty biopharma company.
Not unlike many of its rivals, BMS has been enduring, and continues to face generic competition for several key products with patents set to expire, specifically Abilify, Baraclude, Reyataz and Sustiva.
The company remains focused on its promising immuno-oncology assets, namely Opdivo (nivolumab). In the immuno-oncology race to market, BMS’ closest competitors are Merck, Roche and Novartis. Merck’s lung cancer drug Keytruda, is pending broader approval and has the potential to infringe upon Opdivo sales.
However, Opdivo having been approved three months ahead of schedule in March has BMS in the Lead , and additional indications should keep it there. Opdivo is currently pending in melanoma and non-squamous, non-small- Cell lung cancer. The company recently ended a pivotal Phase III Opdivo study in the later indication, citing positive results. The drug sold $40 million in 1Q15 and analysts estimate it could reach $3.1 billion by 2017.
BMS beats forecasts
In looking at the numbers, BMS has a decent track record delivering positive earnings, and this past year, despite Patent losses and looming competition, continued to make headway. Eliquis sales grew by $628 million; Orencia was up 14%; Sprycel, up 17%; Yervoy grew 36%; and the hepatitis C franchise had combined sales of $256 million.
In addition to generic competition, 2014 results were impacted by the divested diabetes alliance in February 2014, with revenues down 82% for products that include: Bydureon, Byetta, Farxiga, Onglyza/Kombiglyze, Myalept and Symlin.
However, results in the first quarter of 2015 reflect an emerging ascent from the financial impact of losses and competition. Revenues were up 4% to $4.0 billion and earnings were up 27% to $1.2 billion. With additional indications in DVT and PE, Eliquis sales soared to $355 million, up from $106 million a year ago. Yervoy sales were up 20% to $325 million. Orencia and Sprycel grew 10% to $400 million and $375 million, respectively. Daklinza and Sunvepra had combined sales of $264 million, and Opdivo brought in $40 million.
As of April 2015, Erbitux will be one less revenue stream for BMS in the year ahead, having transferred its rights to Lilly in North America, including the U.S., Canada, and PR. The cancer drug generated revenues of $723 million in 2014 (+4%), $682 million of which were from the U.S.
Furthermore, once competition picks up for the company’s top selling drug Abilify and flagship HIV products, Sustiva and Reyataz, BMS will need to recoup these losses quickly to stay afloat.
Several collaborations are underway to further advance Opdivo efforts. One with Five Prime Therapeutics offers the greatest potential in broadly expanding indications. The companies are evaluating the combination of Opdivo and FPA008, Five Prime’s monoclonal Antibody targeting CSF1R, in six cancer types: non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. FPA008 is in development as a potential treatment for rheumatoid arthritis (RA) but preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to an enhanced anti-tumor immune response compared to either therapy alone.
BMS, Ono Pharmaceutical, and Kyowa Hakko Kirin Co. are also collaborating on a Phase I combination study with Opdivo and mogamulizumab, an anti-CCR4 antibody, as a potential treatment for advanced or metastatic solid tumors.
More recently, BMS and Lilly entered a clinical trial collaboration to evaluate Opdivo in combination with Lilly’s galunisertib (LY2157299) as a potential treatment for advanced glioblastoma, hepatocellular carcinoma, and non-small cell lung cancer.
Additionally, an alliance with Rigel Pharmaceuticals based on its portfolio of small molecule TGF beta Receptor Kinase inhibitors, will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers, either as monotherapy or in combination with immune checkpoint inhibitors, including BMS’ Opdivo and Yervoy.
Beyond Opdivo’s imminent success, BMS has two new HIV drugs in late stage trials and 12 therapies in Clinical Trials for diseases including: lupus, rheumatoid arthritis, cancer, thrombosis, fibrosis and genetic diseases. Still holding it own amidst overall industry challenges, BMS continues to make strides.
twitter.com/bmsnews
www.bms.com
| Headcount: | 24,000 | |
| Year Established: | 1887 | |
| Revenues: | $15,879 | (-3%) |
| Net Income: | $2,029 | (-21%) |
| R&D: | $4,534 | (+22%) |
TOP SELLING DRUGS
| Drug | Indication | 2014 Sales | (+/-%) |
| Abilify | schizophrenia, bipolar disorder | $2,020 | -12% |
| Orencia | rheumatoid arthritis | $1,652 | 14% |
| Sustiva Franchise | HIV/AIDS | $1,444 | -11% |
| Reyataz | HIV/AIDS | $1,362 | -12% |
| Baraclude | hepatitis B | $1,441 | -6% |
| Sprycel | leukemia | $1,493 | 17% |
| Yervoy | oncology | $1,308 | 36% |
| Eliquis |
deep vein thrombosis and pulmonary embolism |
$774 | N/A |
For nearly a decade, through acquisitions, divestitures and organic growth, Bristol-Myers Squibb has transformed itself into a highly specialized biopharma company. Five years ago about 40% of its pipeline consisted of biologics and three to five years from now, the company expects that number will grow to about 75%.
As BMS’ biologics portfolio continues to grow, so has its capability to develop and manufacture its products. This past year the company nearly doubled the size of its manufacturing complex in Devens, MA, investing $1 billion and bringing the employee count to 750. BMS is also building a new, large-scale biologics manufacturing facility in Dublin, Ireland to produce a portfolio of approved and investigational biologics covering oncology, virology and immunoscience. This venture will create as many as 400 manufacturing jobs and once completed in 2019, will significantly expand BMS’ biologics manufacturing capacity and play a central role in its global manufacturing network. The cost is expected to match that of the Devens investment.
Charged with carrying these efforts forward, BMS named a new CEO, Giovanni Caforio, M.D. As of May 5, he replaced Lamberto Andreotti who will serve as chairman after his retirement on August 3. Dr. Caforio helped build the company’s immuno-oncology portfolio as chief commercial and chief operating officer, and was integral in shaping the company’s transformation to a specialty biopharma company.
Not unlike many of its rivals, BMS has been enduring, and continues to face generic competition for several key products with patents set to expire, specifically Abilify, Baraclude, Reyataz and Sustiva.
The company remains focused on its promising immuno-oncology assets, namely Opdivo (nivolumab). In the immuno-oncology race to market, BMS’ closest competitors are Merck, Roche and Novartis. Merck’s lung cancer drug Keytruda, is pending broader approval and has the potential to infringe upon Opdivo sales.
However, Opdivo having been approved three months ahead of schedule in March has BMS in the Lead , and additional indications should keep it there. Opdivo is currently pending in melanoma and non-squamous, non-small- Cell lung cancer. The company recently ended a pivotal Phase III Opdivo study in the later indication, citing positive results. The drug sold $40 million in 1Q15 and analysts estimate it could reach $3.1 billion by 2017.
BMS beats forecasts
In looking at the numbers, BMS has a decent track record delivering positive earnings, and this past year, despite Patent losses and looming competition, continued to make headway. Eliquis sales grew by $628 million; Orencia was up 14%; Sprycel, up 17%; Yervoy grew 36%; and the hepatitis C franchise had combined sales of $256 million.
In addition to generic competition, 2014 results were impacted by the divested diabetes alliance in February 2014, with revenues down 82% for products that include: Bydureon, Byetta, Farxiga, Onglyza/Kombiglyze, Myalept and Symlin.
However, results in the first quarter of 2015 reflect an emerging ascent from the financial impact of losses and competition. Revenues were up 4% to $4.0 billion and earnings were up 27% to $1.2 billion. With additional indications in DVT and PE, Eliquis sales soared to $355 million, up from $106 million a year ago. Yervoy sales were up 20% to $325 million. Orencia and Sprycel grew 10% to $400 million and $375 million, respectively. Daklinza and Sunvepra had combined sales of $264 million, and Opdivo brought in $40 million.
As of April 2015, Erbitux will be one less revenue stream for BMS in the year ahead, having transferred its rights to Lilly in North America, including the U.S., Canada, and PR. The cancer drug generated revenues of $723 million in 2014 (+4%), $682 million of which were from the U.S.
Furthermore, once competition picks up for the company’s top selling drug Abilify and flagship HIV products, Sustiva and Reyataz, BMS will need to recoup these losses quickly to stay afloat.
Several collaborations are underway to further advance Opdivo efforts. One with Five Prime Therapeutics offers the greatest potential in broadly expanding indications. The companies are evaluating the combination of Opdivo and FPA008, Five Prime’s monoclonal Antibody targeting CSF1R, in six cancer types: non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. FPA008 is in development as a potential treatment for rheumatoid arthritis (RA) but preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to an enhanced anti-tumor immune response compared to either therapy alone.
BMS, Ono Pharmaceutical, and Kyowa Hakko Kirin Co. are also collaborating on a Phase I combination study with Opdivo and mogamulizumab, an anti-CCR4 antibody, as a potential treatment for advanced or metastatic solid tumors.
More recently, BMS and Lilly entered a clinical trial collaboration to evaluate Opdivo in combination with Lilly’s galunisertib (LY2157299) as a potential treatment for advanced glioblastoma, hepatocellular carcinoma, and non-small cell lung cancer.
Additionally, an alliance with Rigel Pharmaceuticals based on its portfolio of small molecule TGF beta Receptor Kinase inhibitors, will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers, either as monotherapy or in combination with immune checkpoint inhibitors, including BMS’ Opdivo and Yervoy.
Beyond Opdivo’s imminent success, BMS has two new HIV drugs in late stage trials and 12 therapies in Clinical Trials for diseases including: lupus, rheumatoid arthritis, cancer, thrombosis, fibrosis and genetic diseases. Still holding it own amidst overall industry challenges, BMS continues to make strides.
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Although BMS has had a slight downward shift in the rankings this year, it isn’t showing any signs of slacking with its cancer therapies. BMS’ Phase III trial CheckMate-067 was headline news at ASCO presenting promising outcomes with combination therapy for patients with metastatic Stage III & Stage IV melanoma. The company is in the race to head up the immuno-oncology sector alongside Merck, and as things stand this seems to be going in its favor. There are some that question whether immunotherapy may be a victim of its own success for big pharma, as they have been shown to be effective in a short space of time, but at this moment in time I suspect this isn’t on BMS’ mind. With treatment per patient around $150,000 a go, this promises to be a whopper! Not content with its own pipeline, BMS recently acquired Flexus Biosciences and announced a strategic partnership with Rigel Pharmaceuticals. Focusing strongly on immunotherapy BMS has four of its eight drugs in the development pipeline in this category and have now taken even more under its wings to create potential new treatments. Not forgetting that BMS also has its alliances with Pfizer in hematology and its HIV and Hepatitis portfolio, things seem to be rosy for the foreseeable future. —Adele Graham-King |
