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This week, Eli Lilly (LLY - Free Report) , Bayer (BAYRY - Free Report) and Novo Nordisk (NVO - Free Report) announced second-quarter earnings. Novo Nordisk’s new study showed that its weight-loss drug, Wegovy cuts the risk of strokes or heart attacks by 20%. Novartis’ (NVS - Free Report) phase III studies on pipeline candidate, remibrutinib showed rapid symptom control in chronic spontaneous urticaria. The FDA approved J&J’s (JNJ - Free Report) drug Talvey (talquetamab)for heavily pretreated multiple myeloma.
Recap of the Week’s Most Important Stories
Earnings Update: Lilly’s second-quarter results were strong as it beat estimates for both earnings and sales. The company witnessed strong volume growth of Mounjaro, Verzenio, Jardiance and Taltz, which made up for the decline in sales of Alimta due to the loss of exclusivity in the United States and no COVID revenues in the quarter. With demand for weight loss drugs rising rapidly, better-than-expected sales of Mounjaro, which has shown promise in obesity studies, caught investor attention. In addition, Lilly raised its earnings and sales guidance for the year.
Novo Nordisk’s earnings and sales missed estimates. Total revenues rose 32% at CER. Sales in its Diabetes and Obesity Care segment rose 44% at CER while sales in the Rare disease segment were down 20% year over year. In the Diabetes and Obesity Care segment, Wegovy sales skyrocketed 543% at CER. Novo Nordisk raised its sales growth expectations for 2023 from 24%-30% to 27%-33% at CER backed by higher expectations for sales of its GLP-1-based diabetes products like Ozempic. Operating profit is now expected to register 31%-37% growth at CER as compared with the earlier forecast of 28%-34%.
Bayer announced weak results for the second quarter, missing estimates for earnings as well as sales. Sales in the Crop Science unit declined 18.5% (Fx & portfolio adjusted), mainly weighed down by the poor performance of the glyphosate-based products. Revenues in the Pharmaceuticals segment rose 0.2% year over year, while Consumer Health sales rose 5.4%.
In July, Bayer lowered its previously issued financial guidance for 2023 due to a significant decline in sales of glyphosate-based products. On the second-quarter conference call, Bayer maintained its lowered guidance. The company expects to generate currency-adjusted sales of €48.5-€49.5 billion, down from the previous expectation of €51-€52 billion in 2023. Core earnings per share are projected to be around €6.20 to €6.40 on a currency-adjusted basis compared with €7.20 to €7.40 expected previously.
Novo Nordisk’s Obesity Drug Wegovy Cuts Heart Risk: Novo Nordisk announced headline results from the SELECT cardiovascular outcomes study, which evaluated its obesity drug Wegovy (semaglutide 2.4 mg), for the prevention of major adverse cardiovascular events over a period of up to five years. The data from the study showed that Novo Nordisk’s Wegovy reduced the risk of a major cardiovascular event like a stroke by 20% in adults who are overweight or obese, thereby meeting the study’s primary objective. People with obesity have a high risk of cardiovascular disease. However, no drug approved to treat obesity has, until now, shown any benefit in reducing the risk of heart attack, stroke or cardiovascular death. The SELECT study demonstrated that Wegovy has the potential to reduce cardiovascular risk.
Novo Nordisk expects to file regulatory applications to seek approval for Wegovy for expanded use to reduce cardiovascular events in overweight/obese individuals in 2023.
NVO entered into an agreement to acquire Inversago Pharma, a Montreal-based private company, which makes CB1 receptor-based therapies for obesity, diabetes and complications associated with metabolic disorders. Inversago’s lead development asset is INV-202, an oral CB1 inverse agonist, which has demonstrated weight loss potential in a phase Ib trial and is currently in a phase II trial for diabetic kidney disease. For the deal, Novo Nordisk will make an upfront payment of up to $1.075 billion to Inversago Pharma. The deal is expected to be completed before the end of 2023.
FDA Approves J&J’s Multiple Myeloma Drug Talvey (talquetamab): J&J announced that the FDA has granted accelerated approval to its GPRC5D CD3 bispecific antibody Talvey (talquetamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma who have received at least four prior therapies. In clinical studies which evaluated Talvey in heavily pretreated patients including those treated with prior BCMA-targeted bispecific or CAR-T cell therapy, it showed an overall response rate of more than 70% with durable responses. However, the label of Talvey comes with a boxed warning for cytokine release syndrome and neurologic toxicity.
Novartis’s Urticaria Candidate Meets Goal in Studies: Novartis announced that its two-phase III studies evaluating remibrutinib., an oral BTK inhibitor, in patients with chronic spontaneous urticaria met all primary and secondary endpoints. The primary endpoint of the study was absolute change from baseline in weekly urticaria activity score at Week 12. The studies, REMIX-1 and REMIX-2, showed rapid, clinically meaningful improvements across urticaria disease activity scores. In fact, patients in the remibrutinib arm experienced rapid improvement as early as two weeks after starting treatment with the drug. Final 52-week data from the study are expected to be presented at an upcoming medical meeting. Regulatory submissions for the candidate are expected in 2024.
The NYSE ARCA Pharmaceutical Index rose 5.39% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY, BAYRY Post Q2 Results, NVO's Wegovy Cuts Heart Attack Risk
This week, Eli Lilly (LLY - Free Report) , Bayer (BAYRY - Free Report) and Novo Nordisk (NVO - Free Report) announced second-quarter earnings. Novo Nordisk’s new study showed that its weight-loss drug, Wegovy cuts the risk of strokes or heart attacks by 20%. Novartis’ (NVS - Free Report) phase III studies on pipeline candidate, remibrutinib showed rapid symptom control in chronic spontaneous urticaria. The FDA approved J&J’s (JNJ - Free Report) drug Talvey (talquetamab)for heavily pretreated multiple myeloma.
Recap of the Week’s Most Important Stories
Earnings Update: Lilly’s second-quarter results were strong as it beat estimates for both earnings and sales. The company witnessed strong volume growth of Mounjaro, Verzenio, Jardiance and Taltz, which made up for the decline in sales of Alimta due to the loss of exclusivity in the United States and no COVID revenues in the quarter. With demand for weight loss drugs rising rapidly, better-than-expected sales of Mounjaro, which has shown promise in obesity studies, caught investor attention. In addition, Lilly raised its earnings and sales guidance for the year.
Novo Nordisk’s earnings and sales missed estimates. Total revenues rose 32% at CER. Sales in its Diabetes and Obesity Care segment rose 44% at CER while sales in the Rare disease segment were down 20% year over year. In the Diabetes and Obesity Care segment, Wegovy sales skyrocketed 543% at CER. Novo Nordisk raised its sales growth expectations for 2023 from 24%-30% to 27%-33% at CER backed by higher expectations for sales of its GLP-1-based diabetes products like Ozempic. Operating profit is now expected to register 31%-37% growth at CER as compared with the earlier forecast of 28%-34%.
Bayer announced weak results for the second quarter, missing estimates for earnings as well as sales. Sales in the Crop Science unit declined 18.5% (Fx & portfolio adjusted), mainly weighed down by the poor performance of the glyphosate-based products. Revenues in the Pharmaceuticals segment rose 0.2% year over year, while Consumer Health sales rose 5.4%.
In July, Bayer lowered its previously issued financial guidance for 2023 due to a significant decline in sales of glyphosate-based products. On the second-quarter conference call, Bayer maintained its lowered guidance. The company expects to generate currency-adjusted sales of €48.5-€49.5 billion, down from the previous expectation of €51-€52 billion in 2023. Core earnings per share are projected to be around €6.20 to €6.40 on a currency-adjusted basis compared with €7.20 to €7.40 expected previously.
Novo Nordisk’s Obesity Drug Wegovy Cuts Heart Risk: Novo Nordisk announced headline results from the SELECT cardiovascular outcomes study, which evaluated its obesity drug Wegovy (semaglutide 2.4 mg), for the prevention of major adverse cardiovascular events over a period of up to five years. The data from the study showed that Novo Nordisk’s Wegovy reduced the risk of a major cardiovascular event like a stroke by 20% in adults who are overweight or obese, thereby meeting the study’s primary objective. People with obesity have a high risk of cardiovascular disease. However, no drug approved to treat obesity has, until now, shown any benefit in reducing the risk of heart attack, stroke or cardiovascular death. The SELECT study demonstrated that Wegovy has the potential to reduce cardiovascular risk.
Novo Nordisk expects to file regulatory applications to seek approval for Wegovy for expanded use to reduce cardiovascular events in overweight/obese individuals in 2023.
NVO entered into an agreement to acquire Inversago Pharma, a Montreal-based private company, which makes CB1 receptor-based therapies for obesity, diabetes and complications associated with metabolic disorders. Inversago’s lead development asset is INV-202, an oral CB1 inverse agonist, which has demonstrated weight loss potential in a phase Ib trial and is currently in a phase II trial for diabetic kidney disease. For the deal, Novo Nordisk will make an upfront payment of up to $1.075 billion to Inversago Pharma. The deal is expected to be completed before the end of 2023.
FDA Approves J&J’s Multiple Myeloma Drug Talvey (talquetamab): J&J announced that the FDA has granted accelerated approval to its GPRC5D CD3 bispecific antibody Talvey (talquetamab) as monotherapy for adult patients with relapsed and refractory multiple myeloma who have received at least four prior therapies. In clinical studies which evaluated Talvey in heavily pretreated patients including those treated with prior BCMA-targeted bispecific or CAR-T cell therapy, it showed an overall response rate of more than 70% with durable responses. However, the label of Talvey comes with a boxed warning for cytokine release syndrome and neurologic toxicity.
Novartis’s Urticaria Candidate Meets Goal in Studies: Novartis announced that its two-phase III studies evaluating remibrutinib., an oral BTK inhibitor, in patients with chronic spontaneous urticaria met all primary and secondary endpoints. The primary endpoint of the study was absolute change from baseline in weekly urticaria activity score at Week 12. The studies, REMIX-1 and REMIX-2, showed rapid, clinically meaningful improvements across urticaria disease activity scores. In fact, patients in the remibrutinib arm experienced rapid improvement as early as two weeks after starting treatment with the drug. Final 52-week data from the study are expected to be presented at an upcoming medical meeting. Regulatory submissions for the candidate are expected in 2024.
The NYSE ARCA Pharmaceutical Index rose 5.39% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Lilly rose the most (up 16.1%), while Roche declined the most (0.5%).
In the past six months, Lilly has risen the most (48.8%), while Pfizer has declined the most (18.8%).
(See the last pharma stock roundup here: AZN, SNY, ABBV Q2 Results, MRK, MRNA Cancer Jab in Phase III)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.