07.20.18
Headquarters: New York, NY
twitter.com/bmsnews
www.bms.com
Headcount: 25,000
Year Established: 1887
Revenues: $20,776 (+7%)
Net Income: $975 (-78%)
R&D: $6,411 (+30%)
TOP SELLING DRUGS
Although industry analysts predicted the demise of the blockbuster era, we can see with Opdivo and Eliquis, it is alive and well as these drugs continue to experience strong global growth, while capturing market share. Opdivo and Eliquis sales soared to $4.9 billion each, up 31% and 46%, respectively. This growth helped offset declines for several of its key legacy products. Heavy competition has eviscerated the Hepatitis C Franchise with sales falling 74% to $406 million for the year, and all but disappeared in 1Q18 with sales of just $3 million.
In the first quarter of 2018, revenues were up 5% to $5.2 billion, driven by Eliquis sales, up 37%, Opdivo sales, up 34% and Orencia sales, up 11%, while Sprycel and Yervoy sales declined 5% and 25%, respectively. Yervoy is expected to rebound if use with Opdivo increases. The chemotherapy-sparing combination recently won U.S. approval to treat advanced kidney cancer.
In 2017 earnings were impacted by a one-time $2.9 billion charge resulting from U.S. tax reform. Also, R&D expenses were up 30% primarily attributed to the Opdivo expansion, along with higher license and asset acquisition charges. However, R&D expenses are expected to decline and stabilize in the next few years.
A couple of investments aim to bolster BMS’ biologics portfolio. This past August, BMS acquired IFM Therapeutics for $300 million upfront and as much as $1 billion in milestones. BMS gained full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the immune response to treat cancer. IFM’s STING program includes a lead asset against this target, while the NLRP3 agonist program includes a first-in-class pipeline candidate.
Expanding its oncology development program with an immunotherapy for a broad range of tumor indications, BMS gained an exclusive license for the development and commercialization of ONO-4578, Ono Pharmaceutical’s Phase I selective Prostaglandin E2 (PGE2) receptor 4 (EP4) antagonist. The companies will also collaborate on discovery efforts to identify additional compounds from Ono’s PGE2 receptor antagonist programs. BMS paid $40 million upfront and will be responsible for the development, manufacturing and commercialization.
To accommodate this growing biologics portfolio, BMS sold its small molecule API manufacturing facility in Swords, Ireland, to SK Biotek in order to shift its manufacturing focus in Ireland with an ongoing investment in the Cruiserath biologics facility.
Opdivo Expansion Efforts
BMS paid $1 billion upfront and made an equity investment of $850 million in Nektar Therapeutics to develop and commercialize Nektar’s lead immuno-oncology program, NKTR-214 in combination with Opdivo and Opdivo plus Yervoy, in more than 20 indications across nine tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties. Pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.
NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer cells directly in the tumor and increase PD-1 expression on those immune cells.
In a major advance for Opdivo + Yervoy, BMS reported an improvement in progression-free survival in patients with advanced non-small cell lung cancer (NSCLC), a common form of lung cancer, in the first-line setting. The Phase III study evaluated patients who had tumor mutation burden regardless of PD-L1 expression. BMS and several other pharma companies had previously seen mixed data evaluating first-line advanced NSCLC patients using the PD-L1 biomarker, so this is promising. Roche, AstraZeneca, and Merck are also pursuing this indication.
Importantly, the study will advance to evaluate the co-primary endpoint of overall-survival. If the Opdivo + Yervoy combo demonstrates that patients can live longer compared to chemotherapy alone, it would be a huge advantage for BMS.
Additionally, promising data from BMS’ IDO inhibitor drug in combination with Opdivo showed impressive efficacy in patients with heavily pre-treated bladder cancer and cervical cancer.
Additional late-stage efforts include a Phase III trial, in partnership with Exelixis, to evaluate Opdivo in combination with Cabometyx (cabozantinib) tablets, a small molecule inhibitor of receptor tyrosine kinases, or Opdivo and Yervoy in combination with Cabometyx versus sunitinib in advanced or metastatic renal cell carcinoma. The primary endpoint for the trial is progression-free survival.
Also, an alliance with Clovis Oncology is evaluating the combination of Opdivo and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca in Phase III trials in advanced ovarian cancer, and advanced triple-negative breast cancers.
Early Research efforts in collaboration with TARIS Biomedical, AbbVie, and Daiichi are underway evaluating potential new indications for Opdivo. A clinical collaboration with TARIS Biomedical is evaluating TARIS’ investigational product, TAR-200 (GemRIS), in combination with Opdivo in a Phase Ib trial in patients with muscle invasive bladder cancer.
Another clinical collaboration with AbbVie is evaluating the combination of AbbVie’s antibody drug conjugate ABBV-399 and Opdivo in a Phase 1b study in c-Met overexpressing NSCLC. This study could expand into additional solid tumors in the future.
Finally, an alliance with Daiichi Sankyo is evaluating Opdivo and Daiichi’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and bladder cancers.
Alliance Endeavors
Several collaborations aim to advance drug development efforts leveraging real-world data and technology. Real World Evidence (RWE) promises to help advance drug development and timelines and BMS is betting on this through an expanded agreement with Flatiron Health. It provides access to Flatiron’s real-world data to help accelerate BMS’ R&D efforts across a range of tumors, as well as improve its ability to generate additional evidence on the use of its cancer medicines outside of clinical trials.
BMS partnered with Illumina to leverage its next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays to support its oncology portfolio. The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers. BMS’ development program includes 24 clinical-stage molecules designed to target different immune system pathways across more than 50 types of cancers, and through its translational capabilities, has identified a number of potentially predictive biomarkers.
twitter.com/bmsnews
www.bms.com
Headcount: 25,000
Year Established: 1887
Revenues: $20,776 (+7%)
Net Income: $975 (-78%)
R&D: $6,411 (+30%)
TOP SELLING DRUGS
Drug | Indication | 2017 Sales | (+/-%) |
Opdivo | melanoma, lung cancer, renal cancer | $4,948 | 31% |
Eliquis | deep vein thrombosis and pulmonary embolism | $4,872 | 46% |
Orencia | rheumatoid arthritis | $2,479 | 9% |
Sprycel | leukemia | $2,005 | 10% |
Yervoy | oncology | $1,244 | 18% |
Baraclude | hepatitis B | $1,052 | -12% |
Sustiva Franchise | HIV/AIDS | $729 | -32% |
Reyataz | HIV/AIDS | $698 | -23% |
Hepatitis C Franchise | HCV | $406 | -74% |
Although industry analysts predicted the demise of the blockbuster era, we can see with Opdivo and Eliquis, it is alive and well as these drugs continue to experience strong global growth, while capturing market share. Opdivo and Eliquis sales soared to $4.9 billion each, up 31% and 46%, respectively. This growth helped offset declines for several of its key legacy products. Heavy competition has eviscerated the Hepatitis C Franchise with sales falling 74% to $406 million for the year, and all but disappeared in 1Q18 with sales of just $3 million.
In the first quarter of 2018, revenues were up 5% to $5.2 billion, driven by Eliquis sales, up 37%, Opdivo sales, up 34% and Orencia sales, up 11%, while Sprycel and Yervoy sales declined 5% and 25%, respectively. Yervoy is expected to rebound if use with Opdivo increases. The chemotherapy-sparing combination recently won U.S. approval to treat advanced kidney cancer.
In 2017 earnings were impacted by a one-time $2.9 billion charge resulting from U.S. tax reform. Also, R&D expenses were up 30% primarily attributed to the Opdivo expansion, along with higher license and asset acquisition charges. However, R&D expenses are expected to decline and stabilize in the next few years.
A couple of investments aim to bolster BMS’ biologics portfolio. This past August, BMS acquired IFM Therapeutics for $300 million upfront and as much as $1 billion in milestones. BMS gained full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the immune response to treat cancer. IFM’s STING program includes a lead asset against this target, while the NLRP3 agonist program includes a first-in-class pipeline candidate.
Expanding its oncology development program with an immunotherapy for a broad range of tumor indications, BMS gained an exclusive license for the development and commercialization of ONO-4578, Ono Pharmaceutical’s Phase I selective Prostaglandin E2 (PGE2) receptor 4 (EP4) antagonist. The companies will also collaborate on discovery efforts to identify additional compounds from Ono’s PGE2 receptor antagonist programs. BMS paid $40 million upfront and will be responsible for the development, manufacturing and commercialization.
To accommodate this growing biologics portfolio, BMS sold its small molecule API manufacturing facility in Swords, Ireland, to SK Biotek in order to shift its manufacturing focus in Ireland with an ongoing investment in the Cruiserath biologics facility.
Opdivo Expansion Efforts
BMS paid $1 billion upfront and made an equity investment of $850 million in Nektar Therapeutics to develop and commercialize Nektar’s lead immuno-oncology program, NKTR-214 in combination with Opdivo and Opdivo plus Yervoy, in more than 20 indications across nine tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties. Pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.
NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer cells directly in the tumor and increase PD-1 expression on those immune cells.
In a major advance for Opdivo + Yervoy, BMS reported an improvement in progression-free survival in patients with advanced non-small cell lung cancer (NSCLC), a common form of lung cancer, in the first-line setting. The Phase III study evaluated patients who had tumor mutation burden regardless of PD-L1 expression. BMS and several other pharma companies had previously seen mixed data evaluating first-line advanced NSCLC patients using the PD-L1 biomarker, so this is promising. Roche, AstraZeneca, and Merck are also pursuing this indication.
Importantly, the study will advance to evaluate the co-primary endpoint of overall-survival. If the Opdivo + Yervoy combo demonstrates that patients can live longer compared to chemotherapy alone, it would be a huge advantage for BMS.
Additionally, promising data from BMS’ IDO inhibitor drug in combination with Opdivo showed impressive efficacy in patients with heavily pre-treated bladder cancer and cervical cancer.
Additional late-stage efforts include a Phase III trial, in partnership with Exelixis, to evaluate Opdivo in combination with Cabometyx (cabozantinib) tablets, a small molecule inhibitor of receptor tyrosine kinases, or Opdivo and Yervoy in combination with Cabometyx versus sunitinib in advanced or metastatic renal cell carcinoma. The primary endpoint for the trial is progression-free survival.
Also, an alliance with Clovis Oncology is evaluating the combination of Opdivo and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca in Phase III trials in advanced ovarian cancer, and advanced triple-negative breast cancers.
Early Research efforts in collaboration with TARIS Biomedical, AbbVie, and Daiichi are underway evaluating potential new indications for Opdivo. A clinical collaboration with TARIS Biomedical is evaluating TARIS’ investigational product, TAR-200 (GemRIS), in combination with Opdivo in a Phase Ib trial in patients with muscle invasive bladder cancer.
Another clinical collaboration with AbbVie is evaluating the combination of AbbVie’s antibody drug conjugate ABBV-399 and Opdivo in a Phase 1b study in c-Met overexpressing NSCLC. This study could expand into additional solid tumors in the future.
Finally, an alliance with Daiichi Sankyo is evaluating Opdivo and Daiichi’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and bladder cancers.
Alliance Endeavors
Several collaborations aim to advance drug development efforts leveraging real-world data and technology. Real World Evidence (RWE) promises to help advance drug development and timelines and BMS is betting on this through an expanded agreement with Flatiron Health. It provides access to Flatiron’s real-world data to help accelerate BMS’ R&D efforts across a range of tumors, as well as improve its ability to generate additional evidence on the use of its cancer medicines outside of clinical trials.
BMS partnered with Illumina to leverage its next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays to support its oncology portfolio. The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers. BMS’ development program includes 24 clinical-stage molecules designed to target different immune system pathways across more than 50 types of cancers, and through its translational capabilities, has identified a number of potentially predictive biomarkers.