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Will Reblozyl Enable BMY to Offset the Impact of Generic Competition?
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Key Takeaways
BMY's Reblozyl posted Q1 sales of $478M, up 35% year over year, highlighting strong growth momentum.
Reblozyl missed the primary endpoint in a phase III study for myelofibrosis-associated anemia treatment.
BMY aims to consult FDA and EMA despite mixed phase III study results.
Bristol Myers’ ((BMY - Free Report) ) is striving hard for the label expansion of its key drugs. The company’s growth portfolio comprises Opdivo, Orencia, Yervoy, Reblozyl, Opdualag, Abecma, Zeposia, Breyanzi, Camzyos, Sotyku, Krazati and others.
Among these, Reblozyl is one of the top drugs. It generated sales of $478 million in the first quarter, up 35% year over year.
Reblozyl is indicated in the United States for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions and anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular RBC transfusions.
It is also approved for anemia failing an erythropoiesis stimulating agent and requiring 2 or more red RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
However, the phase III study INDEPENDENCE on Reblozyl did not meet its primary endpoint. The study was evaluating Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving RBC transfusions.
The study did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within the first 24 weeks of treatment, compared to placebo.
Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl, in line with previous results from the phase II study.
Several important secondary measures also showed a clinically meaningful benefit favoring Reblozyl.
Nonetheless, BMY plans to engage with the FDA and EMA to discuss the submission of marketing applications.
Competition for BMY’s Reblozyl
Keros Therapeutics ((KROS - Free Report) ), a clinical-stage biopharmaceutical company, is evaluating in adults with transfusion-dependent anemia with very low, low, or intermediate risk MDS.
KROS recently dosed the first patient in a phase III RENEW study. The dosing of the first patient triggered a $10 million milestone payment to Keros under the global license agreement with Takeda.
Reblozyl also competes with established ESAs like Procrit (epoetin alfa), though it works through different mechanisms.
Johnson & Johnson’s ((JNJ - Free Report) ) Procrit is a prescription medicine used to treat anemia. JNJ’s Procrit works like the human protein called erythropoietin to help the body make more RBCs.
BMY’s Price Performance, Valuation and Estimates
Shares of Bristol Myers have lost 9.6% year to date against the industry’s growth of 0.7%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, BMY’s shares currently trade at 7.78x forward earnings, lower than its mean of 8.52x and the large-cap pharma industry’s 14.91X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has moved down to $6.37 from $6.89 in the past 60 days and that for 2026 has declined 6 cents.
Image: Shutterstock
Will Reblozyl Enable BMY to Offset the Impact of Generic Competition?
Key Takeaways
Bristol Myers’ ((BMY - Free Report) ) is striving hard for the label expansion of its key drugs. The company’s growth portfolio comprises Opdivo, Orencia, Yervoy, Reblozyl, Opdualag, Abecma, Zeposia, Breyanzi, Camzyos, Sotyku, Krazati and others.
Among these, Reblozyl is one of the top drugs. It generated sales of $478 million in the first quarter, up 35% year over year.
Reblozyl is indicated in the United States for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions and anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular RBC transfusions.
It is also approved for anemia failing an erythropoiesis stimulating agent and requiring 2 or more red RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
However, the phase III study INDEPENDENCE on Reblozyl did not meet its primary endpoint. The study was evaluating Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving RBC transfusions.
The study did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within the first 24 weeks of treatment, compared to placebo.
Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl, in line with previous results from the phase II study.
Several important secondary measures also showed a clinically meaningful benefit favoring Reblozyl.
Nonetheless, BMY plans to engage with the FDA and EMA to discuss the submission of marketing applications.
Competition for BMY’s Reblozyl
Keros Therapeutics ((KROS - Free Report) ), a clinical-stage biopharmaceutical company, is evaluating in adults with transfusion-dependent anemia with very low, low, or intermediate risk MDS.
KROS recently dosed the first patient in a phase III RENEW study. The dosing of the first patient triggered a $10 million milestone payment to Keros under the global license agreement with Takeda.
Reblozyl also competes with established ESAs like Procrit (epoetin alfa), though it works through different mechanisms.
Johnson & Johnson’s ((JNJ - Free Report) ) Procrit is a prescription medicine used to treat anemia. JNJ’s Procrit works like the human protein called erythropoietin to help the body make more RBCs.
BMY’s Price Performance, Valuation and Estimates
Shares of Bristol Myers have lost 9.6% year to date against the industry’s growth of 0.7%.
Image Source: Zacks Investment Research
From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, BMY’s shares currently trade at 7.78x forward earnings, lower than its mean of 8.52x and the large-cap pharma industry’s 14.91X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has moved down to $6.37 from $6.89 in the past 60 days and that for 2026 has declined 6 cents.
Image Source: Zacks Investment Research
BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.