Earlier on Wednesday, Denmark's most valuable company, Novo Nordisk A/S (NYSE:NVO), reported second-quarter earnings that missed the analyst consensus.
In its quarterly earnings presentation, Novo Nordisk said that in January 2024, it submitted the results from Wegovy STEP HFpEF trials for regulatory review in the US and EU.
Based on interactions with the FDA, the company has decided to withdraw the file. It expects to resubmit the file at the beginning of 2025 with additional relevant data, including data from the once-weekly injectable semaglutide 1.0 mg kidney outcomes trial.
The company conducted two HFpEF trials in patients with established HFpEF 1 in diabetes and one in patients without diabetes but with obesity.
"When we did the meta-analysis of the two trials, we see a 69% decrease in risk of CV death or hospitalization for heart failure, so absolutely very strong data," said Martin Holst Lange, Executive Vice President, Head of Development, in a conference call.
However, since the studies were "reasonably small," Lange added that the FDA wanted to see an increase in the volume of events to substantiate the effect of treatment with semaglutide.
In August 2023, Novo Nordisk announced results from the phase 3 STEP HFpEF trial of once-weekly semaglutide 2.4 mg in adults with heart failure with preserved ejection fraction (HFpEF).
In March, Wegovy was approved to reduce the risk of cardiovascular events in adults with established heart disease who are obese or overweight.
Due to portfolio considerations, Novo Nordisk terminated the development of Phase 1 once-monthly dual GLP-1/GIP receptor agonist and Phase 1 trial of VAP-1i in MASH.
Second quarter sales increased 25% to DKK 68.06 billion ($10.21 billion), slightly below the consensus of DKK 68.65 billion ($10.3 billion).
Ozempic sales reached DKK 28.9 billion ($4.3 billion), up 30% at constant currency. Wegovy revenues increased 53% to DKK 11.7 billion ($1.76 billion).
In the U.S., demand for Wegovy exceeds supply, and to safeguard continuity of care, the supply of the initiation dose strength remains capped. Wegovy has achieved broad commercial formulary access, with more than 200,000 weekly prescriptions and around 35,000 weekly new-to-brand prescriptions.
Total weekly prescriptions for Wegovy have around doubled compared to the beginning of the year.
Sales of Saxenda decreased by 19% to DKK 2.25 billion as the obesity care market is moving towards once-weekly treatments.
Novo Nordisk reported a second-quarter net income of DKK 4.49 per share, up 4% year over year, missing the consensus of DKK 5.05.
Price Action: NVO stock is down 7.73% at $120.07 at the last check on Wednesday.
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Image By Natalia Varlei On Shutterstock
週三早些時候，丹麥最有價值的公司Novo Nordisk A/S (NYSE:NVO)報告了第二季度收益，未達到分析師共識。
Novo Nordisk在季度收益報告中表示，2024年1月，該公司已將Wegovy STEP HFpEF試驗結果提交美國和歐盟監管機構審查。
基於與FDA（美國食品藥品監管局）的互動，公司決定撤回文件。它預計將於2025年初重新提交文件，包括來自一週注射型semaglutide 1.0毫克腎臟結果試驗的相關數據。
公司在患有1型糖尿病的HFpEF患者和肥胖但沒有糖尿病的患者中進行了兩項HFpEF試驗。
在電話會議上，執行副總裁兼開發負責人Martin Holst Lange說：“當我們對兩項試驗進行元分析時，我們看到心血管死亡或心力衰竭住院的風險下降了69％，因此數據非常強大。”
然而，由於這些研究“相當小”，Lange補充說，FDA想要看到事件數量的增加，以證實semaglutide治療效果的影響。
2023年8月，諾和諾德公佈了一週注射型semaglutide 2.4毫克治療心力衰竭患者的第三期STEP HFpEF試驗結果。
今年3月，Wegovy獲批用於降低肥胖或超重成人已確診心臟病的心血管事件的風險。
由於組合考慮，Novo Nordisk終止了1期每月雙重GLP-1/GIP受體激動劑和MASH中一期VAP-1i試驗的開發。
第二季度銷售額增長25%，達到680.6億丹麥克朗（約合102.1億美元），略低於686.5億丹麥克朗（約合103億美元）的共識。
Ozempic銷售額達到289億丹麥克朗（約合43億美元），按固定匯率計算增長30％。Wegovy的收入增長53%，達到117億丹麥克朗（約合17.6億美元）。
在美國，Wegovy的需求超過供應，在保障醫療的連續性方面，初始劑量的供應仍然受到限制。Wegovy已經實現廣泛的商業配方訪問，每週處方超過200,000個，每週新處方約35,000個。
與年初相比，Wegovy的總每週處方量增加了約一倍。
由於肥胖治療市場正在轉向一週一次的治療方案，Saxenda的銷售額下降了19％，達到22.5億丹麥克朗。
Novo Nordisk報告第二季度淨收益每股4.49丹麥克朗，同比增長4％，低於5.05丹麥克朗的共識。
股票價格：截至週三最後一次檢查，NVO股價下跌7.73％，爲120.07美元。
圖片來自Natalia Varlei的Shutterstock
