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Friday, September 20, 2024

Novavax Lags on Q2 Earnings & Gross sales, Cuts ’24 Outlook – Fulcrum Therapeutics (NASDAQ:FULC), Novavax (NASDAQ:NVAX)


Novavax NVAX posted earnings per share of 99 cents in second-quarter 2024, lacking the Zacks Consensus Estimate of $1.82. Nonetheless, earnings rose 71% 12 months over 12 months.

Revenues within the quarter amounted to $415.5 million, additionally lacking the Zacks Consensus Estimate of $453.7 million. The highest line declined 2% on a year-over-year foundation.

Quarter in Element

Within the reported quarter, the corporate recorded $19.9 million in product gross sales in contrast with $285.2 million within the year-ago quarter. Whereas this reported determine did beat our mannequin estimates of round $15 million, it missed the Zacks Consensus Estimate of $26 million.

In the course of the quarter, NVAX recorded $395.6 million in licensing, royalties and different revenues in contrast with the year-ago quarter’s revenues of $2.2 million. This determine contains $391 million related to the upfront fee of $500 million obtained by administration as a part of the just lately signed settlement with pharma big Sanofi SNY for its protein-based COVID-19 vaccine, Nuvaxovid.

Administration didn’t report any grant revenues through the quarter. Administration recorded $137.1 million as grant revenues within the year-ago quarter.

Within the reported quarter, analysis and improvement (R&D) bills had been $107 million, down 51% 12 months over 12 months. The draw back was brought on by a discount in scientific and manufacturing spending through the quarter.

Promoting, normal and administrative (SG&A) bills had been up 8% 12 months over 12 months to $101 million, primarily as a consequence of sure charges paid in affiliation with signing the Sanofi Settlement.

As of Jun 30, 2024, the corporate had $1.1 billion of money and money equivalents in contrast with $496 million as of Mar 31, 2024.

Steering

For 2024

Novavax expects complete revenues within the vary of $700-$800 million in 2024, a minimize down from its previously-issued steerage of $970 million to $1.17 billion (which incorporates practically $70 million in fairness funding). This fall in steerage is probably going as a consequence of decrease COVID-19 vaccine uptake in ex-U.S. markets.

This revised steerage contains practically $425 million in licensing, royalties and different revenues. This contains $400 million of income recognition related to the $500 million upfront fee from the Sanofi settlement and the remaining in royalty and different revenues from partner-related actions.

It expects full-year product income steerage to be $275-$375 million.

The corporate maintained its full-year mixed R&D and SG&A bills within the band of $700-$750 million.

Past 2024

Administration issued new steerage on mixed R&D and SG&A bills for the complete years 2025 and 2026. It now targets the mixed bills to be under $500 million for 2025 and under $350 million for 2026. It additionally expects a portion of the prices of each these years to be reimbursed by Sanofi.

The remaining $100 million of the upfront fee from Sanofi shall be evenly break up throughout 2025 and 2026.

Regardless of the curtailed steerage and lower-than-expected outcomes, Novavax’s shares had been up 9% on Aug 8, probably as a result of discount in working bills past 2024. 12 months thus far, the inventory has surged 143.3% in opposition to the business’s 3.5% fall.

Zacks Investment Research

Picture Supply: Zacks Funding Analysis

Current Updates

In Might, NVAX signed a multi-billion-dollar take care of Sanofi. Starting subsequent 12 months, the corporate will acquire rights to co-market Nuvaxovid globally, besides in sure nations the place Novavax has present partnership agreements. The France-based drugmaker additionally has the only license to develop and market the Novavax vaccine together with its influenza vaccine.

In return, Sanofi will make an upfront fee of $500 million to Novavax and as much as $700 million in milestone funds, totaling as much as $1.2 billion. It is going to be eligible to obtain tiered double-digit share royalty funds on gross sales by Sanofi of Nuvaxovid, Sanofi’s influenza-COVID mixture vaccine and another mixture vaccines that Sanofi could develop, together with Nuvaxovid.

Each firms will nonetheless have the suitable to develop their very own mixed COVID-19-influenza mixture vaccines and adjuvanted merchandise at their very own price. Along with the above deal, Novavax additionally obtained an fairness funding of practically $70 million from Sanofi in change for a 4.9% stake.

Novavax has submitted two regulatory filings with the FDA — one searching for to acquire an emergency use authorization (EUA) for its up to date 2024-2025 components COVID-19 vaccine and one other searching for full approval for the COVID-19 vaccine. Whereas the choice for the primary submitting is anticipated to be obtained earlier than the beginning of the 2024-2025 vaccination season, a remaining resolution for the second submitting is anticipated by April 2025.

Administration can also be on observe to provoke a late-stage research on its COVID-19-Influenza Mixture (CIC) vaccine and standalone influenza vaccines by this 12 months’s finish. It intends to report information from this research in mid-2025.

Novavax, Inc. Worth

Novavax, Inc. Price

Novavax, Inc. worth | Novavax, Inc. Quote

Zacks Rank & Key Picks

Novavax at present carries a Zacks Rank #3 (Maintain). Some better-ranked shares within the total healthcare sector embody Entrada Therapeutics and Fulcrum Therapeutics FULC, every sporting a Zacks Rank #1 (Robust Purchase).

Previously 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have improved from 14 cents to 13 cents. Estimates for 2025 have improved from $3.44 to $3.21 throughout the identical interval. 12 months thus far, shares of Entrada Therapeutics have misplaced 4.2%.

Earnings of Entrada Therapeutics beat estimates in two of the final 4 quarters whereas lacking the mark on two different events. Entrada delivered a four-quarter common earnings shock of 42.18%.

Previously 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 throughout the identical interval. 12 months thus far, shares of Fulcrum Therapeutics have risen 32.5%.

Earnings of Fulcrum Therapeutics beat estimates in every of the final 4 quarters. Fulcrum delivered a four-quarter common earnings shock of 393.18%.

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