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Sept 16 (Reuters) - Beyondspring Inc BYSI.O:
BEYONDSPRING PRESENTS EFFICACY/SAFETY RESULTS FROM A PHASE 2 STUDY OF PEMBROLIZUMAB PLUS PLINABULIN/DOCETAXEL IN METASTATIC NSCLC AFTER PROGRESSING ON FIRST-LINE IMMUNE CHECKPOINT INHIBITORS AT ESMO CONGRESS 2024
Source text for Eikon: (Full Story)
Further company coverage: BYSI.O
Thursday, Moderna Inc unveiled key updates at its annual R&D Day by reducing annual R&D spending by $1.1 billion by 2027, enabling a focus on ten prioritized products.
The company expects R&D expenses to fall from $4.8 billion in 2024E to $3.6 billion—$3.8 billion in 2027.
The strategy, expanding its portfolio into oncology and rare diseases, positions Moderna to deliver ten product approvals within the next three years.
Oppenheimer downgraded Moderna stock from Outperform to Perform and removed the price target.
Oppenheimer analyst writes that with a restructured R&D budget, Moderna’s non-respiratory assets will play a larger role in shaping the pipeline and face increased pressure to reach commercialization.
Also Read: Moderna’s Investigational Mpox Vaccine More Effective Than Current Approved Shot, Animal Study Shows.
RBC Capital Market decreased the price target from $90 to $75 while maintaining the Sector rating.
The analyst notes the COVID-19 vaccine maker pushed its breaking-even event by two years to 2028.
The analyst remains confident in Moderna’s cancer vaccine and the potential of its broader platform over the long term. However, near-term challenges continue to be seen, such as declining COVID-19 vaccination rates and the gradual uptake of the respiratory syncytial virus (RSV) vaccine.
Needham’s analyst highlights substantial commercial and competitive challenges in the respiratory vaccine market across all indications. Investors appear to view cytomegalovirus (CMV) as a less significant commercial opportunity, while the rare disease programs, including MMA and PA, are expected to have only modest peak sales potential, estimated at around $500 million.
The analyst says the INT Oncology program, developed in partnership with Merck & Co Inc , offers the most upside potential. However, progress has been slow, and revenue from this program is unlikely to materialize before 2027 or later. Needham maintains the Hold rating.
William Blair notes that Moderna’s pattern of issuing high financial expectations, followed by lowered guidance, has negatively impacted the company’s stock.
Since cutting its 2024 revenue forecast during its second-quarter earnings 2024 call, the stock has dropped approximately 40%.
The analyst highlights that although Moderna has now pushed back its goal of breaking even to 2028, it will still need to double its revenue from the projected $3.0 billion-$3.5 billion in 2024 to $6.0 billion by 2028 to achieve breakeven along with reduced operating costs and streamlined COGS.
Piper Sandler reiterates the Overweight rating on Moderna but lowers the price target to $115 from $157.
Price Action: MRNA stock closed lower by 2.01% to $68.28 on Friday.
Read Next:
Photo via Wikimedia Commons
Latest Ratings for MRNA
Date | Firm | Action | From | To |
---|---|---|---|---|
Mar 2022 | Deutsche Bank | Maintains | Hold | |
Feb 2022 | Morgan Stanley | Maintains | Equal-Weight | |
Feb 2022 | SVB Leerink | Maintains | Underperform |
View More Analyst Ratings for MRNA
View the Latest Analyst Ratings
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
At its annual R&D Day, Moderna MRNA announcedseveral updates about the advancements in its pipeline and its business outlook for the next four years.
MRNA to Cut R&D Costs, Stops Five Pipeline Programs
Management implemented a portfolio prioritization and cost efficiencies program to reduce annual research and development (R&D) expenses and focus on products that are either nearing approvals or already on the market.
The firm reduced its overall R&D budget for the next four years (2025 to 2028) by nearly 20% to $16 billion. To meet these numbers, management decided to discontinue five pipeline programs as part of this prioritization program. This includes a preclinical vaccine candidate against the four endemic human coronaviruses and four early-stage programs — a study on RSV vaccine in infants, a KRAS-targeting cancer vaccine, a cancer drug and a drug for congestive heart failure.
Moderna expects to secure the FDA’s approval for 10 new products over the next three years. To achieve this goal, management intends to submit three regulatory filings seeking the FDA’s approval before this year’s end. This includes fresh regulatory filings for mRNA-1283 (next-generation COVID-19 vaccine) and mRNA-1083 (COVID-19 and influenza combination vaccine). Management also plans to file a regulatory filing for RSV vaccine mResvia seeking label expansion for use in high-risk adults aged 18-59 years. mResvia is currently approved for use in older adults aged 60 years and older.
To accelerate the regulatory timeline for these three filings, MRNA intends to support each of these filings with a priority review voucher (PRV). Using these vouchers brings down the FDA’s review period for each filing by a period of four months. In this regard, management updated its R&D budget for 2024, increasing it to $4.8 billion, up from the previous guidance of $4.5 billion. This rise is primarily driven by the purchase of these PRVs.
For 2025, MRNA expects R&D expenses to be between $4.2 billion and $4.5 billion. Management expects to save costs starting in 2027, where it expects R&D costs to be between $3.6 billion and $3.8 billion.
MRNA’s Sales Guidance Fails to Impress Investors
While management issued fresh sales guidance for full-year 2025, it also revised the previously issued sales outlook for 2028.
Moderna expects to generate revenues between $2.5 billion to $3.5 billion in 2025. The Zacks Consensus Estimate for 2025 revenues stands at $4.1 billion.
For 2026-2028, management expects sales to grow at a CAGR of more than 25%, driven by new product launches. This revised guidance was lower than the sales guidance issued by MRNA last year. Per the previous guidance, management expected an additional $10-$15 billion in annual sales of cancer, rare and latent disease therapies by 2028.
Post the announcement, shares of Moderna were down more than 12% on Thursday. The above sales guidance did not sit well with investors which were either lowered by management or were below Wall Street expectations.
In the year so far, the stock declined 29.9% compared with the industry’s 0.8% fall.
Other Financial Guidance
The company projects selling, general and administrative (SG&A) expenses for 2025 to be between $1.0 billion and $1.2 billion. For 2026-2028, management expects selling expenses to rise incrementally while the general and administrative portion of the expenses is expected to remain flat during this period.
Moderna also said it plans to break even on an operating cash cost basis in 2028, two years later than the previously announced goal of 2026.
Pipeline Updates
Cancer Therapy
Moderna is developing mRNA-4157, an investigational individualized neoantigen therapy (INT), in partnership with Merck MRK. Moderna/Merck are evaluating mRNA-4157 in two pivotal phase III studies for melanoma and non-small cell lung cancer (NSCLC) indications. Since the onset of this year, Moderna/Merck initiated three new clinical studies evaluating mRNA-4157 across cutaneous squamous cell carcinoma (CSCC), renal cell carcinoma and muscle-invasive bladder cancer indications.
Both Moderna and Merck intend to focus on the late-stage studies evaluating mRNA-4157. The companies have been engaged in discussions with the FDA, which does not support accelerated approval based on data from mid-stage studies.
Influenza Vaccine
Management provided an update on its seasonal influenza vaccine candidate, mRNA-1010. It plans to start a confirmatory late-stage study evaluating mRNA-1010’s vaccine efficacy, using funds secured from Blackstone Life Sciences. The company had previously planned to seek accelerated approval from the FDA based on data from previously completed clinical studies on the vaccine.
Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with GSK plc’s GSK Fluarix and Sanofi’s SNY Fluzone HD. The GSK vaccine is approved for use in individuals aged six months and older. The Sanofi vaccine is approved for use in older adults aged 65 years and above.
Others
Moderna is evaluating its CMV vaccine candidate mRNA-1647 in the pivotal phase III CMVictory study in women aged 16 to 40 years. Data from this study is expected as early as 2024-end.
Management announced plans to start a pivotal late-stage study on its norovirus vaccine candidate mRNA-1403. It is also on track to begin generating pivotal data from separate phase I/II studies on its methylmalonic acidemia (MMA) and propionic acidemia (PA) therapies.
Our Take
Moderna, once a financial powerhouse due to its COVID-19 vaccine, is now facing uncertainty in maintaining demand for its COVID-19 vaccine. The company's revenue forecasts for its RSV vaccines also remain uncertain, given the recently issued CDC recommendations, which trim down a market that already has two major competitors — GSK and Pfizer. The FDA's reluctance to grant accelerated approval to mRNA-4157 dampens the prospect of an early product launch.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
MRNA Zacks Rank
Moderna currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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