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☆ Novavax stock falls 20% as vaccine maker misses quarterly estimates, sees sluggish 2024 sales
▼ + stars: | 2024-02-28 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Novavax generated fourth-quarter sales of $291.3 million, down from the $357.4 million in the year-earlier period. Novavax expects full-year 2024 revenue to come in between $800 million and $1 billion. Novavax anticipates first-quarter revenue to come in at $100 million, which reflects the tail end of the current Covid vaccination season. The cuts will help Novavax focus on further developing its combination vaccine targeting Covid and the flu, which it plans to launch in 2026. On Thursday, Novavax said it will settle a bitter arbitration dispute with Gavi, a nongovernmental global vaccine organization, over a canceled Covid vaccine purchase agreement.

Persons: Novavax, John Jacobs, Jacobs, Gavi Organizations: LSEG, CNBC, CNBC PRO

A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. Still, the Maryland-based biotech, which has been banking on cost cuts and commercial sales of its retooled COVID shot to help it stay afloat, reiterated its "going concern warning". The company expects the 2023-2024 U.S. market for COVID shots to be between 30 million and 50 million doses. The company's updated COVID shot, using a more traditional technology than the mRNA-based vaccines of rivals Pfizer (PFE.N) and Moderna (MRNA.O), was authorized in the U.S. in October. Novavax missed out on the COVID vaccine windfall that benefited rivals due to manufacturing issues that delayed its filing for approval when the pandemic was raging.

Persons: Dado Ruvic, Novavax, Jim Kelly, John Jacobs, Jacobs, Bhanvi, Patrick Wingrove, Sriraj Kalluvila, Bill Berkrot Organizations: REUTERS, U.S, Department of Health, Human Services, Pfizer, Moderna, Thomson Locations: Maryland, U.S, United States, Bengaluru, New York

A vial labelled "Novavax COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. The Maryland-based company, whose COVID vaccine is its lone marketed product, has adopted cost-cutting measures and is counting on commercial sales of its updated shot to help it stay afloat. The CDC's Advisory Committee on Immunization Practices (ACIP) will not meet again to discuss the Novavax shot, a spokesperson said. Novavax's original COVID shot received U.S. authorization in July 2022, long after Pfizer and Moderna vaccines were in use. All three of the updated shots target the XBB.1.5 variant of the coronavirus.

Persons: Dado Ruvic, BioNTech, COVID, John Jacobs, Jacobs, Sriparna Roy, Bill Berkrot Organizations: REUTERS, U.S . Food, Drug Administration, U.S . Centers for Disease Control, Prevention, Pfizer Inc, Moderna, FDA, Pfizer, Moderna's, Thomson Locations: U.S, Maryland, Bengaluru

The Food and Drug Administration on Tuesday granted emergency use authorization to the updated COVID-19 vaccine from Novavax, marking the third new coronavirus shot that will be made available to the public ahead of the winter and the only not produced with messenger RNA technology. FDA authorized the shot for people ages 12 and older just weeks after shots from Moderna and Pfizer rolled out. “Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Some individuals are skeptical of the new technology, instead opting for Novavax’s more traditional use of protein-based technology. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”

Persons: “, ” Peter Marks, ”, John Jacobs Organizations: Drug Administration, FDA, Moderna, Pfizer, FDA’s, Biologics, Research, Health, Covid Locations: U.S

☆ FDA authorizes updated Novavax Covid vaccine as Pfizer, Moderna shots roll out in U.S.
▼ + stars: | 2023-10-03 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

"In the coming days, individuals in the U.S. can go to major pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine." Last month, the FDA and CDC greenlit XBB.1.5 shots from Pfizer and Moderna for all Americans ages six months and older. The end of that declaration means all three manufacturers will sell their updated shots directly to health-care providers and vie for commercial market share. That includes the Biden administration's Bridge Access Program, which will provide Covid vaccines at no cost to underinsured and uninsured people. It's unclear how many Americans will actually roll up their sleeves and take the new vaccines from Novavax, Pfizer and Moderna.

Persons: Novavax, John Jacobs, fends, Demetre Daskalakis, Biden, it's, Eris, Megan Wallace Organizations: Drug Administration, Pfizer, Moderna, Centers for Disease Control, Covid, FDA, CDC, EG, Biden Locations: U.S, Novavax

GUIDONIA MONTECELIO, Italy (AP) — European captain Luke Donald was delivering his Ryder Cup victory speech in front of a giddy crowd at Marco Simone when his celebrating players standing beside him started a chant that quickly swept through the grandstands. Ineligible for this year’s Ryder Cup, it might be too early for them to be considered for 2025 whatever transpires regarding this “framework agreement” between the Saudi backers of LIV and PGA and European tours. He is already a multiple winner on the European tour. And how about the team having another set of brothers in Matt and Alex Fitzpatrick? “Seve, Ollie, the legends of the Ryder Cup that have come before us,” McIlroy said.

Persons: GUIDONIA MONTECELIO, Luke Donald, Ryder, Marco Simone, ”, Rory McIlroy, Donald, McIlroy, “, Bernard Gallagher, Tony Jacklin, John Jacobs, Gallagher, Henrik Stenson, —, LIV Golf, Lee Westwood, Sergio Garcia, Ian Poulter, Europe’s, LIV, Justin Rose, Molinari, Jon Rahm —, Ludvig Aberg, Robert MacIntyre, Nicolai Hojgaard, ” Rahm, Aberg, Adrien Dumont de Chassart, Rasmus Hojgaard, Nicolai, Rasmus, Alex Fitzpatrick, Matt, Alex, Rahm, Viktor Hovland —, Tommy Fleetwood, Tyrrell Hatton, Shane Lowry, Rose, Seve Ballesteros, Jose Maria Olazabal, “ Seve, Ollie, ” McIlroy Organizations: —, Ryder, Europe’s Ryder, Saudi, PGA Tour University, PGA, U.S, European Masters, Handa Locations: Italy, Rome, Bethpage, New York, Europe, Illinois

☆ Novavax shares jump after Covid vaccine maker posts surprise quarterly profit
▼ + stars: | 2023-08-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Shares of Novavax jumped as much as 20% in premarket trading Tuesday after the Covid vaccine maker reported a surprise second-quarter profit. Here's what Novavax reported compared with Wall Street's expectations, based on a survey of analysts by Refinitiv. That compares with a net loss of $510.5 million, or $6.53 per share, reported during the same quarter last year. But Jacobs noted that the adjustment reflects part of a cash settlement the Canadian government agreed to pay for forfeiting Covid vaccine doses that were previously scheduled for delivery. The company reported R&D expenses of $258 million and SG&A expenses of $162 million last year.

Persons: Novavax, John Jacobs, Jacobs, We're, it's Organizations: Refinitiv, CNBC, and Drug Administration Locations: Krakow, Poland

☆ FDA advisors recommend that new Covid vaccines target an omicron XBB variant this fall
▼ + stars: | 2023-06-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The committee unanimously voted that the new jabs should be monovalent — meaning they are designed to protect against one variant of Covid — and target a member of the XBB family. Those strains of Covid are descendants of the omicron variant, which caused cases to surge to record levels early last year. Advisors also generally agreed that the new shots should specifically target a variant called XBB.1.5. There is also uncertainty about which age groups the FDA and CDC will advise to receive the updated shots this fall. But it's unclear how many Americans will roll up their sleeves to take the updated shots later this year.

Persons: Melinda Wharton, Novavax, John Jacobs, Peter Marks, David Kaslow Organizations: . Food, Centers for Disease Control, Advisors, Pfizer, Moderna, National Center, FDA, CDC, Novavax, omicron Locations: U.S, Novavax

☆ Covid vaccine maker Novavax sees a pathway to survival – but it won’t be easy
▼ + stars: | 2023-06-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +10 min

Jakub Porzycki | NurPhoto | Getty ImagesNovavax has a clear message for Wall Street: The cash-strapped Covid vaccine maker sees a pathway to survival. The 36-year-old company will continue to rely on its protein-based Covid vaccine – its only commercially available product – for most of its revenue this year. Once the U.S. government's supply of free Covid vaccines runs out, all three companies will sell updated shots directly to health-care providers. A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. But Taylor emphasized that the plan will help Novavax refocus on its top priority: delivering an updated vaccine in the coming months.

Persons: Jakub Porzycki, Novavax, Covid, Cowen, Brendan Smith, John Jacobs, Smith, that's, Silvia Taylor, Taylor, Jefferies, Roger Song, Patrick Van Katwijk, Mayank Mamtani, let's, Mamtani, Let's, Song, Ding Genhou Organizations: NurPhoto, Getty, Pfizer, Moderna, CNBC, Food and Drug Administration, World Health Organization, FDA, Dutch Health Service Organization, Riley Securities, U.S, Centers for Disease Control, CDC, Reuters, Visual China Locations: Krakow, Poland, Maryland, U.S, The Hague, Netherlands, Moderna, Geneva, Hohhot, Inner Mongolia Autonomous Region, China

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

☆ Novavax says it is axing 25% of its workforce to cut costs
▼ + stars: | 2023-05-09 | by ( Krystal Hur | ) edition.cnn.com time to read: +1 min

New York CNN —Novavax is laying off 25% of its workforce to slash expenses, the biotech company said Tuesday. Still, the Maryland-based company said it’s focused on updating its Covid vaccine for the fall vaccine season, citing a modified US government agreement for up to 1.5 million additional doses of its Covid vaccine for delivery this year. Novavax expects its broader cost reduction plan, which also includes measures to consolidate facilities and infrastructure, to cut costs by 40% to 50% compared to the previous fiscal year. The US public health emergency is set to end on May 11, meaning Americans could have to start paying out of pocket for Covid testing and treatment. Novavax is the latest company to reduce its headcount to cut costs as companies brace for a possible recession and scale back their workforce after pandemic-era hiring sprees.

Short interest in Novavax increased more than 13% to 37.8 million shares, or about 45% of the total float, between March 15-31, according to data compiled by FactSet. Other biotech companies that saw growing short interest are Cassava Sciences , with a 10% increase, and Fate Therapeutics , which saw a 26% boost. Meanwhile, bluebird bio had a 29% increase in its short interest to 26% of float. Cinemark and AMC Entertainment both saw increases in their short position to 28% and 27% of their respective floats. All names trade on the NYSE or Nasdaq, have short positions amounting to at least 25% of their total float and have market values of at least $100 million.

☆ Novavax cut $50 million in costs, plans to slash more, CEO says
▼ + stars: | 2023-04-12 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

April 12 (Reuters) - Novavax Inc (NVAX.O) cut about $50 million in costs in the first quarter of 2023 and plans to slash more, Chief Executive John Jacobs said in an interview on Wednesday. “We’re looking at everything from buildings, leases, land, headcount, and contractors, every aspect of our company and the way we work,” he told Reuters. Jacobs said Novavax would seek funding for its COVID/influenza combination shot, including a potential partnership, depending on whether the upcoming data is positive. The CEO added that the company did not expect to launch its individual flu vaccine this year, and will focus on the COVID vaccine. Global regulators expect vaccination campaigns to be conducted once a year, similar to annual flu inoculations.

The company — which has its COVID-19 vaccine as the only marketed product after 35 years in business — on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. "While there is the potential for a substantial booster market ... we don't expect Novavax to be a major player in the booster opportunity." As of last close, Novavax's U.S.-listed shares were down 97% from their February 2021 record high of $331.68.

☆ Covid vaccine maker Novavax says it may not survive
▼ + stars: | 2023-03-01 | by ( Paul R. La Monica | ) edition.cnn.com time to read: +2 min

New York CNN —Novavax, which makes the Nuvaxovid vaccine used to treat Covid-19, posted huge sales gains for the past three years during the height of the pandemic. But the company is now facing serious financial challenges — and has even warned it may not be able to survive. Shares of Novavax (NVAX) plunged more than 25% in early morning trading to a new multi-year low of under $7. Novavax hit a 52-week high of about $91 last year and was trading above $330 in February 2021. Novavax isn’t the only Covid-vaccine maker to disappoint Wall Street, though.

The stock had dropped 26.2% to $6.83 around 8:55 ET (13:55 GMT), while its Frankfurt-listed shares slumped more than 27%. The company - whose COVID vaccine is its only marketed product after 35 years in business - on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. As of last close, Novavax's U.S.-listed shares are down 97% from their February 2021 record high of $331.68.

☆ Novavax raises doubts about ability to remain in business, shares fall
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. Novavax's shares closed at $9.26 on Tuesday and fell to $6.90 in extended trading after reporting on its financial situation. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Novavax shares plunge as company raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( ) www.cnbc.com time to read: +4 min

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. Covid-19 vaccine maker Novavax on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered.

☆ Novavax raises doubts about its ability to remain in business
▼ + stars: | 2023-02-28 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

NEW YORK, Feb 28 (Reuters) - COVID-19 vaccine maker Novavax Inc (NVAX.O) on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign. The company lost $182 million, or $2.28 per share, in the fourth quarter on weaker-than-expected sales of $357 million. "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," he said. In the U.S., where the Novavax vaccine was authorized in July 2022, only around 80,000 of its shots have been administered. Jacobs said that while Novavax's vaccine may take longer to manufacture than its rivals from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna (MRNA.O), he believes FDA regulators want a protein-based option this fall for U.S. citizens.

☆ Novavax's longtime CEO Stanley Erck to retire
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - Novavax Inc (NVAX.O) said on Monday its longtime chief executive officer, Stanley Erck, would retire and be succeeded by industry veteran John Jacobs, at a time when the COVID-19 vaccine maker looks to catch up with larger rivals. He joins Novavax from Harmony Biosciences (HRMY.O), where he served as CEO since June 2018. Erck, who has been at the helm of the company since 2011, was responsible for bringing Novavax's COVID vaccine, its first commercial product, to the market. However, the shot has been plagued by manufacturing snags, regulatory delays and sluggish uptake amid a global supply glut for vaccines and waning demand. Reporting by Raghav Mahobe in Bengaluru; Editing by Saumyadeb Chakrabarty and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

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