Originally a Biologist, M.Sc in Biomedicine, PhD in Bioengineerings, and +20 years experience in the research and development of novel Cell & Gene Therapies (CGT) tackling several clinical needs including orthopaedics and rare diseases. As an investor, I have been utilising my background in life sciences to assess the potential of novel treatments, including those using CGT, as well as, their capacity to drive shareholders' returns. Thus, as SA analyst, I will be focusing on analysing biotechnology, pharmac ...

Despite being a pioneer in developing one of the first and most widely used COVID-19 vaccines, shares of Moderna (MRNA) have been sliding down over the past few years due to waning demand for the vaccine.In the past three months, MRNA stock has lost nearly 40%, significantly underperforming the industry’s 17.1% decline, as seen in the chart below. While the company’s pipeline progress has been encouraging, the update to its business outlook for the next four years and a curtailed R&D budget did not sit well ...

Dublin, Dec. 11, 2024 (GLOBE NEWSWIRE) -- The "mRNA Vaccines and Therapeutics Market by Vaccine Type, Treatment Type, Vaccine Manufacturing, Application, End-user, and Region 2024-2032" report has been added to ResearchAndMarkets.com's offering.The global mRNA vaccines and therapeutics market size reached US$ 57.7 billion in 2023. Looking forward, the market is expected to reach US$ 72.7 billion by 2032, exhibiting a growth rate (CAGR) of 2.6% during 2023-2032. The development and acceptance of mRNA-based ...

Summary of Moderna, Inc. Conference Call Company Overview - **Company**: Moderna, Inc. (NASDAQ:MRNA) - **Industry**: Biotechnology, specifically focusing on mRNA vaccines and medicines - **Event**: Piper Sandler 36th Annual Healthcare Conference - **Date**: December 5, 2024 Key Points and Arguments Current Position and Market Dynamics - Moderna is recognized as a leading developer of mRNA vaccines and medicines, currently in a strong position with a robust balance sheet and a de-risked mRNA technology platform [2][2] - The company is preparing for several approvals in its late-stage clinical pipeline over the coming years [2][2] COVID-19 Vaccination and Future Products - The company is focused on increasing COVID vaccination rates, particularly among the elderly, who are at higher risk for hospitalization [8][8] - Moderna's next-generation vaccine, mRNA-1283, is expected to have higher efficacy than its previous product, Spikevax, and is aimed at the elderly population [13][14] - The combination vaccine for COVID and flu is anticipated to be crucial in preventing hospitalizations and saving costs [12][12] RSV Vaccine Launch and Market Strategy - Moderna's RSV vaccine, mRESVIA, is entering a market with significant unmet medical needs, particularly for the elderly and pediatric populations [21][22] - The company acknowledges a slower uptake compared to competitors Pfizer and GSK, attributing this to logistical challenges and timing of market entry [31][32] - Future strategies include bundling vaccines to enhance sales and market penetration [34][35] Cytomegalovirus (CMV) Vaccine Development - Moderna is developing a CMV vaccine, which addresses a significant public health issue, particularly in preventing birth defects [36][37] - The CMV vaccine is seen as a potential $2 billion to $5 billion annual market opportunity, with plans to expand its use to pediatric settings [58][58] - The company is preparing educational campaigns targeting OB/GYNs and the general public to raise awareness about CMV and the vaccine [54][56] Safety and Efficacy Considerations - Moderna's RSV vaccine is expected to have a favorable safety profile compared to competitors, as it has not reported cases of Guillain-Barré syndrome in its Phase 3 studies [30][30] - The company emphasizes the importance of data transparency and public health recommendations to encourage vaccination [9][9] Financial Implications - The next-generation COVID vaccine is expected to command a premium price due to its higher efficacy, benefiting both Moderna and retail partners [15][17] - The use of existing manufacturing capacity for the CMV vaccine is projected to yield high gross margins, enhancing the company's financial outlook [60][60] Additional Important Insights - The company is actively working to counter misinformation surrounding vaccines and is committed to transparency in data sharing [9][9] - Moderna's strategy includes leveraging its mRNA technology to create combination vaccines, which could simplify vaccination processes and improve public health outcomes [12][12] - The company is poised to capitalize on the growing demand for vaccines, particularly in the context of respiratory diseases, which are significant health threats in the U.S. [11][11]

ToplineStocks linked to vaccine developers such as Moderna, Pfizer and Novavax tanked in the leadup to market close Thursday, tumbling after reports surfaced that President-elect Donald Trump would select vaccine skeptic Robert F. Kennedy Jr. as the head of the Department of Health and Human Services.Trump announced his pick Thursday afternoon. (Photo by Tom Brenner for The Washington Post via Getty ... [+] Images)The Washington Post via Getty Images Key FactsTrump confirmed his selection of RFK Jr. on Thur ...

Financial Data and Key Metrics - Revenue for Q3 2024 was $1.9 billion, with net income of $13 million [7] - Cash and investments at the end of Q3 2024 totaled $9.2 billion, down from $10.8 billion at the end of Q2 2024 [32] - Operating expenses were reduced by $500 million year-over-year in Q3 2024, excluding a $1.4 billion charge from Q3 2023 [7] - Cost of sales declined by 77% year-over-year to $514 million in Q3 2024, driven by manufacturing productivity improvements [28] - R&D expenses decreased by 2% year-over-year to $1.1 billion in Q3 2024, excluding a priority review voucher purchase [29] - SG&A expenses decreased by 36% year-over-year to $281 million in Q3 2024, reflecting cost efficiency efforts [30] Business Line Performance - Spikevax (COVID-19 vaccine) achieved a 40% market share in the U.S. retail market for the 2024-2025 season [9] - RSV vaccine (mRESVIA) sales were $10 million in Q3 2024, below expectations due to late approval and competitor inventory buildup [14] - The company expects to increase RSV market share in 2025 with full participation in the contracting season and potential label expansion [15] Market Performance - U.S. market contributed $1.2 billion in product sales in Q3 2024, driven by an earlier vaccine launch and a $140 million provision release [23] - International sales were $0.6 billion in Q3 2024, in line with expectations but lower than the same period in 2023 [25] - The company expects Q4 2024 U.S. product sales to range between $200 million and $500 million, and international sales between $600 million and $800 million [25][27] Strategy and Industry Competition - The company aims to drive COVID vaccination rates closer to flu vaccination rates, particularly in under-penetrated channels like IDNs and government programs [11][13] - Moderna is focusing on educating healthcare providers and consumers about the benefits of COVID vaccination, including reducing the risk of long COVID [12][13] - The company plans to expand its manufacturing footprint in the U.K., Canada, and Australia in 2025 to fulfill multi-year contracts [53] Management Commentary on Operating Environment and Future Outlook - The COVID market is expected to remain a sizable and durable long-term market, with Moderna well-positioned to capture growth [9] - The company is optimistic about the potential for RSV market expansion, particularly with international approvals and potential revaccination recommendations [15] - Moderna is committed to improving cost efficiencies, with a goal to reduce annual R&D expenses by $1.1 billion by 2027 [55] Other Important Information - The company expanded its executive committee, promoting internal talent and emphasizing the integration of digital technology and AI [18][19] - Moderna expects to file for approval of three products in 2024: next-gen COVID vaccine, RSV vaccine for high-risk individuals, and a combination COVID-flu vaccine [54] Q&A Session Summary Question: Rest of world revenue and CMV interim analysis [58] - Rest of world revenue in Q3 2024 was driven by orders from the U.K., Canada, Australia, and Brazil, with most of the $600 million in Q4 expected from contracted volumes [59][60] - For CMV, if the DSMB recommends un-blinding at the interim analysis, the company will share the results; otherwise, it will wait for the final analysis [61] Question: Ex-U.S. COVID revenue contracts and CMV accrual timing [63] - The company has multi-year contracts with some countries, with revenue expected to decline in 2025 before increasing in 2026 [65] - CMV case accrual is steady, and the final analysis could happen quickly after the interim analysis [66] Question: U.S. pricing, reserve returns, and flu-COVID combo [69] - U.S. pricing for COVID vaccines is approximately $63 per dose, and reserve returns for the 2023-2024 season were adjusted to $400 million [70][75] - The company decided not to use a priority review voucher for the flu-COVID combo due to timing constraints, with potential approval in 2025 [71][72] Question: RSV market dynamics and COVID market share [78][107] - The RSV market has been slower than expected, with inventory buildup and delayed CDC guidelines impacting sales [81][82] - Moderna lost some market share in the U.S. retail COVID market but expects to gain a clearer picture of overall market share by the end of the season [108] Question: INT program and manufacturing [90] - The INT manufacturing facility in Massachusetts is on track for completion by year-end, with no bridging work required for FDA approval [91][92] Question: Election impact and RSV international expansion [94] - The company is confident in its ability to work with any administration to advance public health goals [96] - RSV market expansion outside the U.S. is expected to grow, but timing depends on regulatory approvals and pricing negotiations [97][98] Question: Orphan disease pipeline [102] - Pivotal trials for MMA and PA are expected to start in 2025, with potential launches in 2026 or later, depending on enrollment and trial progress [103][104] Question: Flu-COVID combo transition and COVID litigation [118] - The flu-COVID combo is not expected to transition the market in 2025 due to contracting timing, with potential impact in 2026 [119][120] - The company is prepared to defend against GSK's lawsuit, which is common during market formation around new technologies [122]

Moderna (MRNA) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of a loss of $1.89 per share. This compares to loss of $1.39 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 101.59%. A quarter ago, it was expected that this biotechnology company would post a loss of $3.47 per share when it actually produced a loss of $3.33, delivering a surprise of 4.03%.Over the last four quarters, the ...

Moderna on Thursday posted a surprise profit for the third quarter, smashing Wall Street estimates, as its cost-cutting efforts took hold and sales of its Covid vaccine came in higher than expected. The biotech company posted a net income of $13 million, or 3 cents per share, for the third quarter. That compares with a net loss of $3.63 billion, or $9.53 cents per share, reported for the year-ago period.Moderna is slashing expenses, with a recently announced goal of achieving $1.1 billion in savings by 2027 ...

Moderna, Inc. MRNA will release earnings results for its third quarter, before the opening bell on Thursday, Nov. 7.Analysts expect the Cambridge, Massachusetts-based company to report a quarterly loss at $1.9 per share, versus a year-ago loss of $9.53 per share. Moderna projects to report revenue of $1.25 billion for the quarter, compared to $1.83 billion a year earlier, according to data from Benzinga Pro.On Oct. 28, On Monday, Merck & Co Inc MRK and Moderna announced the initiation of INTerpath-009, a pi ...

Moderna (MRNA) is set to report third-quarter 2024 earnings on Nov. 7, before the opening bell. The Zacks Consensus Estimate for sales and earnings is pegged at $1.25 billion and a loss of $1.91 per share, respectively. Both metrics indicate a significant decline from the year-ago levels.Estimates for Moderna’s 2024 loss per share have increased from $9.52 to $9.88 in the past 60 days. During the same period, estimates for 2025 loss per share have risen from $7.37 to $8.59. Image Source: Zacks Investment Re ...