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By Patrick Wingrove
Sept 12 (Reuters) - Moderna MRNA.O on Thursday said it expects sales of between $2.5 billion and $3.5 billion next year, and forecast that new product launches would drive an average annual growth rate of 25% in revenue between 2026 and 2028.
The vaccine maker last month projected sales of $3 billion and $3.5 billion for this year, which will be its lowest annual revenue since Moderna launched its COVID-19 vaccine in late 2020 - the company's first commercial product.
Analysts on average expect the company will generate revenue of $3.27 billion and $3.74 billion for 2024 and 2025, respectively, according to LSEG data.
The company said last year it expected to return to sales growth in 2025.
Moderna Chief Financial Officer James Mock said next year's forecast reflects the uncertainty of the COVID and respiratory syncytial virus (RSV) markets in the U.S., as well as Moderna's prediction that the 10 new products it expects to be approved by 2027 will start to generate meaningful revenue in 2028.
"For 2025, we might have some new product approvals assumed, but there's not assumed to be much revenue from them," he said.
The Cambridge, Massachusetts-based company has been banking on revenue from newer mRNA shots, including its RSV vaccine mRESVIA, to make up for declining revenue from its COVID shot since the end of the pandemic.
Moderna said it plans to submit an application to the U.S. Food and Drug Administration this year to expand approval for its RSV shot to high-risk adults under the age of 60, following new data from a late-stage trial.
The FDA approved Moderna's mRESVIA shot for RSV-associated lower respiratory tract disease in adults aged 60 or older last May, pitting it against rival vaccines from GSK GSK.L and Pfizer PFE.N.
The company also said it had dropped its request for fast-track approval as part of its application to the FDA for a standalone influenza vaccine. It instead will focus on the application for its combination shot to protect against both COVID and influenza, which it plans to submit this year.
Moderna said mRESVIA met all immune-response targets and was found to be safe and well tolerated in adults aged 18 and older with a compromised immune system, but did not provide further details on the new study's findings.
Pfizer said in August that its Abrysvo shot, which was approved last year for adults over the age of 60, generated a strong immune response in high-risk adults aged 18 and older.
The FDA in June expanded the use of GSK's Arexvy vaccine in adults between the ages of 50 and 59. The U.S. Centers for Disease Control and Prevention the same month instead recommended RSV shots be given to all adults 75 and older, as well as those who are 60 to 74 and have an increased risk of severe RSV due to medical conditions.
Moderna also said its standalone flu vaccine met immune-response targets when compared to GSK's Fluarix in a new study, as well as across all strains of the flu in an extension study for older adults compared to Sanofi's SASY.PA Fluzone HD.
It plans to launch an efficacy study for the flu vaccine this year.
(Reporting by Patrick Wingrove in New York; Editing by Bill Berkrot)
(( Patrick.Wingrove@thomsonreuters.com ;))
Keywords: MODERNA-OUTLOOK/ (PIX)
UnitedHealth Group Inc. reportedly announced on Tuesday that it will remove AbbVie Inc.’s blockbuster drug Humira from some of its preferred reimbursement lists starting January 1, 2025. The company will recommend lower-cost biosimilar versions instead.
This move is part of a larger trend in the U.S. pharmaceutical market, as health plans seek to cut costs by promoting alternatives to high-priced drugs.
Reuters highlights that Amgen Inc’s Amjevita, managed by its pharmacy benefits unit, Optum Rx, is among the biosimilars covered under UnitedHealth’s lists for commercial health plans.
With this decision, Optum becomes the last of the three largest U.S. pharmacy benefit managers (PBMs) to exclude Humira.
Cigna Corporation announced last month that it would remove Humira from some of its lists in 2025, following a similar decision by CVS Health Inc’s Caremark unit in April.
CVS’s action led to a swift shift, with more patients transitioning to Sandoz Group AG’s biosimilar version of Humira in just three weeks than in the previous 15 months combined.
Cigna plans to cover biosimilars like Boehringer Ingelheim’s Cyltezo, Simlandi from Teva Pharmaceutical Industries Ltd , and Alvotech’s products, including an unbranded version of Sandoz’s Hyrimoz, as replacements for Humira.
UnitedHealth noted that patients would still have access to Humira until the FDA designates the preferred biosimilars as interchangeable with the original drug, per the report. The FDA is expected to make this designation in 2025.
Despite the growing competition, AbbVie has managed to retain a dominant share of the U.S. Humira market throughout 2023. This has been achieved through favorable negotiations with PBMs, even as biosimilar alternatives from companies like Pfizer Inc entered the market.
As per a Reuters report, Humira has still managed to retain over 80% of its patients even after facing lower-priced rivals in the U.S. over the past year.
Following their launch last year, pharmacy benefit managers largely influenced patient access, with minimal incentive for doctors to switch to these alternatives.
In May, Cantor Fitzgerald said AbbVie had positioned itself to absorb Humira biosimilar erosion and achieve modest operational revenue growth.
Price Action: UNH stock is down 2% at $587.07 at last check Wednesday.
Photo via Shutterstock
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
On Tuesday, BridgeBio Pharma, Inc. released topline results from the Phase 1/2 open-label ADventure study of BBP-631, an investigational adeno-associated virus (AAV) 5 gene therapy, for congenital adrenal hyperplasia (CAH).
CAH is a rare, inherited disorder that affects the adrenal glands and causes a hormone imbalance. The adrenal glands are on top of the kidneys and produce hormones that help the body function.
Also Read: Why Is BridgeBio Pharma Stock Trading Higher On Friday?
To date, key results from the study include:
BBP-631 has been well tolerated, with only mild to moderate treatment-emergent adverse events (TEAEs), and no treatment-related SAEs have been reported.
“While the data to date are not yet transformational, the study showed for the first time that people living with CAH can indeed make their own cortisol, and that gene therapy can be safely administered in this patient population...” said Neil Kumar, CEO and Founder of BridgeBio.
BridgeBio also said it will no longer be pursuing development of BBP-631 for CAH and is seeking partnership opportunities to support future development of BBP-631 or next-generation gene therapies for the treatment of CAH.
Price Action: BBIO stock is down 3.07% at $29.07 at the last check on Wednesday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Ionis Pharmaceuticals IONS announced that it is floating a secondary issue of 11.5 million shares of its common stock to the public at an issue price of $43.50 per share, amounting to nearly $500.3 million.
The company also granted an option to underwriters of the issue to purchase an additional 1.725 million shares at the same price.
The secondary offering is expected to close today.
Buy Why Did IONS Stock Fall?
Ionis’ shares fell more than 12% on Tuesday after the announcement. Though the issue does not significantly dilute the existing shareholder base, the issue price per share did not sit well with investors. The issue price was at a discount to the closing price on Monday, with the stock closing at $48.33.
Year to date, the stock has lost 16.3% compared with the industry’s 0.8% fall.
Plans for the Proceeds
Management plans to use the net proceeds from this new issue and its existing cash balance to fund its independent commercial launches and support the clinical development of its pipeline candidates. Management will also use the proceeds for its general corporate purpose, including working capital requirements.
Ionis Boasts a Diverse Revenue Stream
Despite marketing no wholly-owned drug in its portfolio, Ionis enjoys a diverse stream of revenues, including commercial products and royalties and numerous sources of collaborative and R&D revenues. The company has collaboration deals with leading drugmakers/biotech companies, likeAstraZeneca AZN, Biogen BIIB, GSK plc GSK and Novartis, for developing and marketing its medicines.
IONS earns commercial revenues in the form of royalty payments on net sales of Spinraza, approved in the United States to treat spinal muscular atrophy (SMA) worldwide. Ionis licensed this drug to Biogen, which is responsible for commercializing it. Ionis and Biogen also market Qalsody, which was approved by the FDA in April 2023 for amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutations.
Last December, the FDA approved Wainua for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy, commonly called hATTR-PN or ATTRv-PN. The drug has been developed in partnership with AstraZeneca. While Ionis and AstraZeneca will jointly market Wainua for ATTRv-PN in the United States, AZN has exclusive rights to commercialize Wainua outside U.S. markets. The drug was commercially launched in the United States in first-quarter 2024. Regulatory filings seeking approval for eplontersen in ATTRv-PN are under review in the EU and some other countries.
AstraZeneca and Ionis are also developing Wainua as a treatment for cardiomyopathy caused by hATTR amyloidosis (ATTR-CM) in the phase III CARDIO-TTRansform study, which is on track for a data readout in first-half 2025.
Novartis and GSK are its partners for pelacarsen and bepirovirsen, respectively. While the GSK-partnered drug is being developed in two late-stage studies for chronic hepatitis B (CHB), the Novartis-partnered drug is being developed in a late-stage study for patients with cardiovascular disease due to elevated Lp(a) levels. Data readout from the Novartis- and GSK-partnered drug studies are expected in 2025 and 2026, respectively.
Independent Product Launches Planned by IONS
Ionis’ collaboration with the above leading drugmakers/biotech companies provides it with funds in the form of license fees, upfront payments and milestone payments to invest in its internal pipeline development. Some of its wholly-owned candidates include olezarsen for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG), ulefnersen for ALS, donidalorsen for hereditary angioedema (HAE) and zilganersen for Alexander’s disease. These drugs are already being evaluated in late-stage studies.
In June, the FDA accepted Ionis’ regulatory filing seeking approval for olezarsen to treat FCS. This filing is based on results from the phase III BALANCE study, which showed that treatment with olezarsen led to significant triglyceride-lowering and substantial reductions in acute pancreatitis attacks in FCS patients. If approved, olezarsen will be Ionis’ first medicine that will be launched independently. A final decision from the FDA is expected before Dec. 19, 2024.
In May, Ionis reported top-line results from two phase III studies — OASIS-HAE and OASISplus — which evaluated donidalorsen in HAE patients. Data from these studies showed that treatment with the drug achieved a significant and sustained reduction in the rate of HAE attacks for monthly and every two-month dosing. Based on these results, the company is making preparations to file an NDA for donidalorsen with the FDA in 2024. IONS’ partner, Otsuka, is preparing to submit for marketing approval in Europe before 2024-end.
Management is also progressing well with the development of its other wholly-owned pipeline drugs. In the first half of 2024, Ionis reported that a mid-stage study on MASH/NASH candidate ION224 and a phase I/IIa study on Angelman syndrome drug ION582 achieved their respective primary endpoints. A phase III study on ION582 is expected to begin in the first half of 2025.
Ionis is advancing and expanding its wholly-owned pipeline to drive future revenue growth. While the company does have a broad pipeline of partnered programs with leading drugmakers/biotech companies, its recent decision to increase investments in its internal pipeline seems encouraging, given the recent positive data readouts. The expansion of its internal pipeline will help Ionis diversify its revenue stream and narrow down its dependence on collaboration partners.
Ionis Pharmaceuticals, Inc. Price
Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. Quote
IONS Zacks Rank
Ionis carries a Zacks Rank #3 (Hold) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Investment Research
GSK Plc shelved on Wednesday its herpes simplex virus (HSV) vaccine development program.
The recombinant protein vaccine, dubbed GSK3943104, did not meet the study’s primary efficacy objective.
GSK added that the vaccine candidate will not progress to phase three studies.
No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up.
“Given the unmet medical need and burden associated with genital herpes, innovation in this area is still needed,” the company said. “GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV program.”
There are no approved vaccines for HSV, and GSK’s decision to stop developing GSK3943104 eliminates a key contender in the race to market.
Moderna Inc is developing mRNA-1608, an investigational vaccine for herpes simplex virus type 2. The candidate is currently in phase 1/2 trial that is fully enrolled with 300 participants in the U.S. Data is expected in June 2025.
Pfizer Inc. partner BioNTech SE is developing BNT163, a prophylactic vaccine candidate being studied in a phase one clinical trial.
The German company initiated the phase one trial in December 2022, with an estimated enrollment of 248 participants. Data is expected in 2025.
There are an estimated four billion people globally infected with HSV.
GSK Price Action: GSK stock is down 1.12% at $43.61 at last check Wednesday.
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© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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