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Pharma Stock Roundup: LLY's 2023 View, MRK-MRNA Joint Cancer Vaccine Data & More
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This week, Merck (MRK - Free Report) and Moderna (MRNA - Free Report) announced a breakthrough in their efforts to find a cancer vaccine. Their mRNA-based cancer vaccine showed positive results in a mid-stage study. Eli Lilly (LLY - Free Report) issued its financial guidance for 2023, which lagged investor expectations. The European Commission (EC) granted approval to Sanofi’s (SNY - Free Report) blockbuster immunology medicine Dupixent for prurigo nodularis and Novartis’ (NVS - Free Report) Pluvito for advanced prostate cancer.
Recap of the Week’s Most Important Stories
Lilly Issues 2023 Financial Guidance: Eli Lilly announced its financial guidance for 2023. Lilly expects 2023 revenues to be between $30.3 billion and $30.8 billion, while adjusted earnings per share are expected to be between $8.10 and $8.30. However, the company’s earnings expectations fell short of the Zacks Consensus Estimate of $9.14 per share. Lilly expects volume increases from key growth products to drive the top line, partially offset by lower revenues from cancer drug Alimta due to its loss of patent exclusivity and currency headwinds. Management does not expect to record any revenues from the sales of COVID therapies.
The adjusted gross margin is expected to be approximately 79%. Marketing, selling and administrative expenses are expected to be in the range of $6.9 billion to $7.1 billion. Research and development expense is expected to be in the range of $8.2 billion to $8.4 billion. The tax rate is expected to be around 16% for the full year.
The company also reiterated its previously issued 2022 sales and earnings projections.
Merck/Moderna’s mRNA-based Cancer Vaccine Shows Promising Data in Study: Merck and partner Moderna’s investigational personalized cancer vaccine candidate mRNA-4157/V940 achieved the primary endpoint of recurrence-free survival in the phase IIb KEYNOTE-942 study. The data showed that the combination of mRNA-4157/V940 and Keytruda led to a 44% reduction in the risk of disease recurrence or death against Keytruda alone as an adjuvant treatment for stage III/IV melanoma patients with a high risk of recurrence following complete resection. Moderna and Merck plan to discuss these results with regulatory authorities and also intend to start a phase III study in melanoma patients next year and thereafter to expand to other cancer types. This is the first time any data has been presented for an mRNA-based cancer treatment from a clinical study.
The FDA extended the review timeline by three months of a supplemental new drug application (sNDA) seeking approval for Merck and partner AstraZeneca’s Lynparza’s expanded use in first-line prostate cancer. The sNDA is seeking approval for Lynparza in combination with J&J’s Zytiga (abiraterone) and corticosteroid prednisone or prednisolone for patients with metastatic castration resistant prostate cancer, based on the PROpel study. Earlier, the FDA decision on this sNDA was expected in the fourth quarter.
EU Nod for Sanofi’s Dupixent for 4th Indication: The European Commission approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of moderate-to-severe prurigo nodularis, a chronic inflammatory skin disease in adult patients who are candidates for systemic therapy. Dupixent has become the first and only targeted treatment to be approved for prurigo nodularis in Europe. The approval was based on data from two phase III studies, PRIME and PRIME2, which evaluated the safety and efficacy of Dupixent in adults with prurigo nodularis. Prurigo nodularis is now the fourth disease for which Dupixent is approved in Europe. In the United States, Dupixent is approved to treat five diseases.
EU Nod for Novartis’ Pluvito for Advanced Prostate Cancer: The EC also approved Novartis’ Pluvicto, a targeted radioligand therapy, for treating patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC). Pluvicto has been approved in combination with androgen deprivation therapy (ADT) for mCRPC patients who have been treated with other anticancer treatments like androgen-receptor pathway inhibitor (ARPI) therapy and taxane-based chemotherapy. The approval was based on data from the phase III VISION study on Pluvicto. Pluvicto which was approved to treat PSMA–positive mCRPC in patients who were treated with ARPI and taxane-based chemotherapy in the United States in March. Pluvicto is also being evaluated in other phase III studies for earlier stages of metastatic prostate cancer
The NYSE ARCA Pharmaceutical Index declined 0.14% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY's 2023 View, MRK-MRNA Joint Cancer Vaccine Data & More
This week, Merck (MRK - Free Report) and Moderna (MRNA - Free Report) announced a breakthrough in their efforts to find a cancer vaccine. Their mRNA-based cancer vaccine showed positive results in a mid-stage study. Eli Lilly (LLY - Free Report) issued its financial guidance for 2023, which lagged investor expectations. The European Commission (EC) granted approval to Sanofi’s (SNY - Free Report) blockbuster immunology medicine Dupixent for prurigo nodularis and Novartis’ (NVS - Free Report) Pluvito for advanced prostate cancer.
Recap of the Week’s Most Important Stories
Lilly Issues 2023 Financial Guidance: Eli Lilly announced its financial guidance for 2023. Lilly expects 2023 revenues to be between $30.3 billion and $30.8 billion, while adjusted earnings per share are expected to be between $8.10 and $8.30. However, the company’s earnings expectations fell short of the Zacks Consensus Estimate of $9.14 per share. Lilly expects volume increases from key growth products to drive the top line, partially offset by lower revenues from cancer drug Alimta due to its loss of patent exclusivity and currency headwinds. Management does not expect to record any revenues from the sales of COVID therapies.
The adjusted gross margin is expected to be approximately 79%. Marketing, selling and administrative expenses are expected to be in the range of $6.9 billion to $7.1 billion. Research and development expense is expected to be in the range of $8.2 billion to $8.4 billion. The tax rate is expected to be around 16% for the full year.
The company also reiterated its previously issued 2022 sales and earnings projections.
Merck/Moderna’s mRNA-based Cancer Vaccine Shows Promising Data in Study: Merck and partner Moderna’s investigational personalized cancer vaccine candidate mRNA-4157/V940 achieved the primary endpoint of recurrence-free survival in the phase IIb KEYNOTE-942 study. The data showed that the combination of mRNA-4157/V940 and Keytruda led to a 44% reduction in the risk of disease recurrence or death against Keytruda alone as an adjuvant treatment for stage III/IV melanoma patients with a high risk of recurrence following complete resection. Moderna and Merck plan to discuss these results with regulatory authorities and also intend to start a phase III study in melanoma patients next year and thereafter to expand to other cancer types. This is the first time any data has been presented for an mRNA-based cancer treatment from a clinical study.
The FDA extended the review timeline by three months of a supplemental new drug application (sNDA) seeking approval for Merck and partner AstraZeneca’s Lynparza’s expanded use in first-line prostate cancer. The sNDA is seeking approval for Lynparza in combination with J&J’s Zytiga (abiraterone) and corticosteroid prednisone or prednisolone for patients with metastatic castration resistant prostate cancer, based on the PROpel study. Earlier, the FDA decision on this sNDA was expected in the fourth quarter.
EU Nod for Sanofi’s Dupixent for 4th Indication: The European Commission approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of moderate-to-severe prurigo nodularis, a chronic inflammatory skin disease in adult patients who are candidates for systemic therapy. Dupixent has become the first and only targeted treatment to be approved for prurigo nodularis in Europe. The approval was based on data from two phase III studies, PRIME and PRIME2, which evaluated the safety and efficacy of Dupixent in adults with prurigo nodularis. Prurigo nodularis is now the fourth disease for which Dupixent is approved in Europe. In the United States, Dupixent is approved to treat five diseases.
EU Nod for Novartis’ Pluvito for Advanced Prostate Cancer: The EC also approved Novartis’ Pluvicto, a targeted radioligand therapy, for treating patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC). Pluvicto has been approved in combination with androgen deprivation therapy (ADT) for mCRPC patients who have been treated with other anticancer treatments like androgen-receptor pathway inhibitor (ARPI) therapy and taxane-based chemotherapy. The approval was based on data from the phase III VISION study on Pluvicto. Pluvicto which was approved to treat PSMA–positive mCRPC in patients who were treated with ARPI and taxane-based chemotherapy in the United States in March. Pluvicto is also being evaluated in other phase III studies for earlier stages of metastatic prostate cancer
The NYSE ARCA Pharmaceutical Index declined 0.14% 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, Pfizer rose the most (3.6%), while Lilly declined the most (3.1%).
In the past six months, all the stocks were in the green, with Merck gaining the most (29.6%).
(See the last pharma stock roundup here: SNY, GSK, PFE Relieved on Zantac Win & Other Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.