On Thursday, Piper Sandler reaffirmed its positive stance on Moderna (NASDAQ:MRNA) shares, maintaining an Overweight rating and a $214.00 price target. The biotechnology company, listed on NASDAQ:MRNA, received a nod from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its Monovalent JN.1 COVID Vaccine for the upcoming 2024 season. Additionally, the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), slated for a market launch this fall.
Moderna's management has indicated that they anticipate product sales to reach at least $4.0 billion in 2024, with expectations of growth resuming in 2025. The company is also set to release Phase III data on its combined Flu+COVID vaccine mRNA-1083, as well as potential Phase III CMVictory data on mRNA-1647 within the year.
At the American Society of Clinical Oncology (ASCO) meeting, Moderna presented updated Phase II KEYNOTE-942 data, which showed that the combination of mRNA-4157 and KEYTRUDA led to a 49% relative improvement in relapse-free survival (RFS) and a 62% improvement in distant metastasis-free survival (DMFS) when compared to KEYTRUDA alone.
These results have prompted further collaboration with Merck on Phase III and Phase II/III clinical trials for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and cutaneous squamous cell carcinoma (cSCC).
The company concluded the first quarter of 2024 with a strong balance sheet, reporting $12.2 billion in cash reserves. Moderna's financial guidance anticipates ending the year with approximately $9.0 billion.
In other recent news, Moderna and its partners have made significant strides in their respective fields. Moderna, Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX), and Novavax (NASDAQ:NVAX) have presented promising results for their updated COVID-19 vaccines, which have shown increased efficacy against new strains like KP.2. The U.S. Food and Drug Administration (FDA) is set to decide the focus of the upcoming immunization campaign based on these findings.
In collaboration with Merck, Moderna has also reported a notable reduction in recurrence or death in high-risk melanoma patients from their Phase 2b clinical trial. The combination of mRNA-4157 (V940) with KEYTRUDA (pembrolizumab) resulted in a 49% reduction in risk compared to KEYTRUDA alone. Following these results, further studies have been initiated for patients with various types of cancer.
Moderna's shares have seen an upgrade from RBC Capital Markets following the approval of its Respiratory Syncytial Virus (RSV) vaccine by regulatory authorities. The firm raised the price target to $160 from the previous $135 while maintaining an Outperform rating. The approval of Moderna's RSV vaccine is viewed as positive news, especially considering the successful launch of RSV vaccines by Pfizer and GSK.
Finally, Moderna has received FDA approval for mRESVIA, its mRNA-based vaccine designed to protect adults aged 60 and over from lower respiratory tract disease caused by the RSV. The approval was based on the Phase 3 ConquerRSV clinical trial data, which showed an 83.7% efficacy in preventing RSV lower respiratory tract disease. Moderna anticipates making mRESVIA available for the U.S. population in time for the 2024/2025 respiratory virus season.
InvestingPro Insights
Moderna's financial landscape presents a mixed picture according to recent data from InvestingPro. With a market capitalization of $59.34 billion, the company shows significant size in the biotech industry. Notably, Moderna holds more cash than debt, providing a solid liquidity position as indicated by their substantial cash reserves of $12.2 billion reported in Q1 2024. This aligns with the InvestingPro Tip highlighting the company's liquid assets exceeding short-term obligations, which may offer some resilience against market volatility.
Despite a robust short-term performance, with a 26.78% return over the last month and an impressive 57.84% over the last three months, analysts have expressed concerns by revising their sales expectations downward for the current year. This anticipated sales decline is reflected in the -65.78% revenue growth over the last twelve months as of Q1 2024. Moreover, the company's gross profit margins remain weak at -70.27%, underscoring challenges in profitability.
For investors seeking to delve deeper into Moderna's financials and future outlook, there are additional InvestingPro Tips available that could provide further insights into the company's performance and stock potential. Using the exclusive coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro, where 13 additional tips await to guide investment decisions.
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