axelvento
5 hours ago
With Pfizer hitting a stumbling block, Moderna’s COVID-19/influenza vaccine, mRNA-1083, could be the first such combination vaccine to reach the market. In June, the company posted results from a Phase III trial that showed mRNA-1083 produced a strong immune response against both COVID-19 and influenza. In releasing the results, Moderna also became the first and, due to Pfizer/BioNTech’s struggles, only company to date to post positive Phase III results for a combination COVID-19/influenza vaccine.
https://www.biospace.com/drug-development/5-late-stage-mrna-vaccines-to-watch
DewDiligence
1 week ago
MRNA—(-17%)—cuts costs, pares pipeline—investors unimpressed:
https://finance.yahoo.com/news/moderna-r-d-day-highlights-100000130.html
Annual R&D expenses, expected to be $4.7B in 2024, will be reduced to $3.6-3.8B by 2027. Cumulatively, R&D expenses during the 2025-2028 period will be reduced by 20%. Such a cutback is apparently too little and too slow to placate investors.
Perhaps more important, MRNA now says it expects to reach break-even cash flow in 2028—two years later then the previous guidance.
Moreover, MRNA issued 2025 revenue guidance of $2.5-3.5B, which is down from the (previously reduced) 2024 guidance of $3.0-3.5B (#msg-174849487).
Please see #msg-175048423 for related info.
axelvento
1 week ago
Focuses on ten product approvals through 2027
"Moderna now has five respiratory vaccines with positive Phase 3 results and expects to submit three for approval this year. In addition, we have five non-respiratory products in pivotal studies across cancer, rare diseases and latent vaccines with potential for approval by 2027. Our demonstrated probability of success in R&D has been higher than industry standards at every stage of development," said Stéphane Bancel, CEO of Moderna. "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business."
Moderna's broad clinical success and recent commercial challenges necessitate a more selective and paced approach to its research and development investment. Through portfolio prioritization and cost efficiencies, the Company expects to reduce annual research and development expense by approximately $1.1 billion starting in 2027. During this time, Moderna will expand its commercial portfolio into oncology, rare diseases, and first-in-class non-respiratory vaccines. The Company expects this strategy to yield 10 product approvals over the next three years.
Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion.
Moderna plans to break even on an operating cash cost basis (which excludes stock-based compensation, depreciation and amortization expense) with $6 billion in revenue. The Company expects to achieve this in 2028. The Company has sufficient capital to fund its plans until achieving break even on a cash cost basis without raising additional equity.
https://investors.modernatx.com/news/news-details/2024/Moderna-RD-Day-Highlights-Progress-and-Strategic-Priorities/default.aspx
launch pad$$$$$$$$
DewDiligence
2 weeks ago
MRNA spends far too much, says WSJ’s “Heard-on-the-Street” column:
https://www.wsj.com/finance/stocks/pandemic-darling-moderna-needs-a-reality-check-3c375b0e Moderna’s massive pipeline of 45 therapies and vaccines will be the focus of its R&D day next Thursday. But what investors most want to see is that program being trimmed.
Moderna is now bleeding cash at a worrying pace. Last year it reported a $4.7 billion net loss, and it is now on track to lose at least another $3 billion this year, according to analyst estimates compiled by FactSet. The company has made the case that it should begin to break even by 2026. But that isn’t looking likely given the slow uptake of the company’s second product, an RSV vaccine that has struggled to gain market share against shots from Pfizer and GSK.
… The good news is that, given the size of the company’s massive pipeline, there is plenty of room to find something like $1 billion in cuts.
axelvento
4 weeks ago
Coming Soon: The First mRNA Vaccine for Melanoma........
Moderna and Merck have presented promising results from their phase 2b clinical trial that investigated a combination of a messenger RNA (mRNA) vaccine and a cancer drug for the treatment of melanoma.
Is mRNA set to shake up the world of cancer treatment? This is certainly what Moderna seems to think; the pharmaceutical company has published the results of a phase 2b trial combining its mRNA vaccine (mRNA-4157 [V940]) with Merck's cancer drug KEYTRUDA. While these are not the final results but rather mid-term data from the 3-year follow-up, they are somewhat promising. The randomized KEYNOTE-942/mRNA-4157-P201 clinical trial involves patients with high-risk (stage III/IV) melanoma following complete resection.
Relapse Risk Halved
Treatment with mRNA-4157 (V940) in combination with pembrolizumab led to a clinically meaningful improvement in recurrence-free survival, reducing the risk for recurrence or death by 49%, compared with pembrolizumab alone. The combination of mRNA-4157 (V940) with pembrolizumab also continued to demonstrate a meaningful improvement in distant metastasis-free survival compared with pembrolizumab alone, reducing the risk of developing distant metastasis or death by 62%. "The KEYNOTE-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over pembrolizumab alone in adjuvant melanoma", said Kyle Holen, MD, Moderna's senior vice president, after presenting these results.
Side Effects
The combined treatment also did not demonstrate more significant side effects than pembrolizumab alone. The number of patients reporting treatment-related adverse events of grade 3 or greater was similar between the arms (25% for mRNA-4157 [V940] with pembrolizumab vs 20% for KEYTRUDA alone). The most common adverse events of any grade attributed to mRNA-4157 (V940) were fatigue (60.6%), injection site pain (56.7%), and chills (49%). Based on data from the phase 2b KEYNOTE-942/mRNA-4157-P201 study, the US Food and Drug Administration and European Medicines Agency granted breakthrough therapy designation and recognition under the the Priority Medicines scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma.
Phase 3 Trial
In July, Moderna and Merck announced the launch of a phase 3 trial, assessing "mRNA-4157 [V940] in combination with pembrolizumab as adjuvant treatment in patients with high-risk resected melanoma [stages IIB-IV]." Stéphane Bancel, Moderna's director general, believes that an mRNA vaccine for melanoma could be available in 2025.
DewDiligence
4 weeks ago
PFE/MRNA/NVAX—Street consensus sales for 2H24 COVID vaccines:
https://www.barrons.com/articles/fda-approves-updated-covid-19-shots-pfizer-moderna-5d1d1229 Wall Street analysts expect roughly $2.5 billion in sales of Moderna’s Covid-19 vaccine in the second half of the year, according to FactSet, while they have penciled in $4.5 billion in sales for Pfizer’s version. From Novavax, they expect sales in the second half of just $210 million. The $4.5B 2H24 figure above for PFE is consistent with PFE’s own guidance of $5.0B for the full year (#msg-174835917), since PFE sold $550M of COVID vaccines in 1H24.
MRNA has not given 2024 guidance for COVID-vaccine sales specifically; rather, MRNA guided to $3.0-$3.5B of sales for COVID and RSV vaccines combined (#msg-174849487). In 1H24, MRNA sold $350M of COVID vaccines and its RSV vaccine had not yet launched.