Ocedurenone

Novo Nordisk's flagship obesity treatment Wegovy returned to forecast-topping growth in the company's latest financial results, sending shares up more than 8% on Wednesday. Sales of the GLP-1 product surged 79% in the third quarter to DKK 17.3 billion ($2.5 billion), well above consensus expectations of DKK 15.9 billion.While sales of Wegovy had grown 55% in the previous quarter to DKK 11.7 billion, they came in below consensus estimates of DKK 13.5 billion — a "blip" that Novo attributed to an adjustment of rebates related to estimates made on the prior year's revenue.And ahead of Novo's latest financial print, fears of a repeat in the third quarter had been stoked by Eli Lilly's disappointing sales figures for its competing GLP-1/GIP co-agonist products Mounjaro and Zepbound. Revenue for the two came in below analyst predictions, which Lilly blamed on inventory decreases in the US wholesaler channel. On Wednesday, Novo CEO Lars Fruergaard Jørgensen said that the pharma continues to see "very significant demand" for Wegovy in the US and is working hard to increase manufacturing capacity. However, the company warned that despite earmarking billions of dollars to invest in production, it still faces "capacity limitations" at some sites, along with "periodic supply constraints and related drug-shortage notifications."Weak diabetes sales"Wegovy continues to gain momentum and clearly exceeds expectations in the quarter," compensating for weaker diabetes sales, remarked Sydbank analyst Søren Løntoft Hansen. "This is good enough to provide some relief," added Emily Field of Barclays, explaining that Wegovy's beat came despite slightly worse pricing in the US than anticipated.Novo's overall sales and profit both increased 21% in the third quarter to DKK 71.3 billion and DKK 27.3 billion, respectively. However, the revenue figure came in below analyst projections of DKK 72.3 billion, partly due to lacklustre growth in its diabetes segment, including for Ozempic.In the quarter, Ozempic — which contains the same active ingredient as Wegovy — generated sales of DKK 29.8 billion, up 26% year-over-year at constant currencies, but below forecasts of DKK 30.5 billion.Guidance narrowedFor the full year, Novo said it now expects sales growth of between 23% and 27% on a constant exchange rate basis, narrowed from a prior range of 22% to 28%. Meanwhile, operating profit growth was similarly revised, and is now seen between 21% and 27%, from previous guidance of 20% to 28%.Investors had feared the drugmaker would cut its outlook, noted Terence McManus of Bellevue Asset Management. "However, we don't see these results as an all-clear signal on the stock," he added, with all eyes now set to turn to pending late-stage data for its next obesity hopeful dubbed CagriSema.The therapy, which combines semaglutide — the active ingredient in Ozempic and Wegovy — with the amylin analogue cagrilintide, is expected to lead to weight loss of over 15% when results are unveiled later this year. Martin Holst Lange, Novo's development head, reaffirmed that CagriSema has potential for up to 25% weight loss, with "no change in our confidence level."Other pipeline updatesNovo also disclosed alongside its financial print that the Phase IIIb STRIDE study of Ozempic as an adjunct to standard of care in people with type 2 diabetes and peripheral arterial disease with intermittent claudication met its primary endpoint. The drug demonstrated a clinically relevant and statistically significant improvement in maximum walking distance of 13% compared to placebo. US and EU marketing applications in this indication are targeted for the first half of 2025.Additionally, the company plans regulatory filings next year for its factor VIIIa mimetic bispecific antibody Mim8 in haemophilia A. Following up on the positive Phase IIIa FRONTIER 2 trial, Novo said Wednesday that the Phase IIIb FRONTIER 5 study has now been completed. The trial assessed switching from prophylaxis with Roche's once-weekly therapy Hemlibra (emicizumab) to Mim8 — something Novo reported was well tolerated.Elsewhere, Novo said it has now decided to bin development of the non-steroidal mineralocorticoid receptor antagonist ocedurenone across all indications. The future of the asset — gained from KBP Biosciences for up to $1.3 billion — was under review following the failure in June of the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease.($1 = DKK 6.92889)

Bagsværd, 7 August 2024 - Financial report for the period 1 January 2024 to 30 June 2024 Operating profit increased by 18% in Danish kroner and by 19% at constant exchange rates (CER) to DKK 57.8 billion. Operating profit is impacted by the impairment loss related to ocedurenone of DKK 5.7 billion. Sales in North America Operations increased by 36% in Danish kroner (36% at CER). Sales growth in the US was positively impacted by gross-to-net sales adjustments related to prior years. Sales in International Operations increased by 9% in Danish kroner (11% at CER).Sales within Diabetes and Obesity care increased by 26% in Danish kroner to DKK 125.0 billion (27% at CER), mainly driven by GLP-1 diabetes sales growth of 32% in Danish kroner (32% at CER) and Obesity care growing by 37% in Danish kroner to DKK 24.9 billion (37% at CER). Rare disease sales decreased by 4% measured in Danish kroner (3% at CER).Within R&D, Novo Nordisk successfully completed the phase 3 FRONTIER 2 trial with Mim8, where once-weekly and once-monthly Mim8 demonstrated superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A. In June 2024, Novo Nordisk announced that the ocedurenone CLARION-CKD phase 3 trial was stopped, as ocedurenone failed to meet the primary endpoint.Also within R&D, Novo Nordisk received a Complete Response Letter from the Food and Drug Administration (FDA) for insulin icodec in July. In Obesity care, Novo Nordisk received a positive CHMP opinion, based on the SELECT trial, for an update of the Wegovy® label to reflect risk reduction of major adverse cardiovascular events in the EU.For the 2024 outlook, sales growth is now expected to be 22-28% at CER, and operating profit growth is now expected to be 20-28% at CER. Growth reported in Danish kroner is now expected to be 1 percentage point lower than at CER growth for both sales and operating profit. PROFIT AND LOSSH1 2024H1 2023Growthas reportedGrowthat CER*DKK million Net sales 133,409 107,667 24% 25% Operating profit 57,780 48,895 18% 19% Net profit 45,457 39,242 16% N/ADiluted earnings per share (in DKK) 10.17 8.71 17% N/A* CER: Constant exchange rates (average 2023). Lars Fruergaard Jørgensen, president and CEO: "We are pleased with the sales growth in the first half of 2024, which has enabled us to raise the outlook for the full year. The growth is driven by the increased demand for our GLP-1-based diabetes and obesity treatments, and we continue to reach more patients with our innovative treatments. Within R&D, we are very pleased with the first phase 3 trial results with Mim8 and its potential for people living with haemophilia A, and with the recent recommendation for a label extension for cardiovascular risk reduction for Wegovy® in the EU." About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 69,000 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown+45 3079 9289abmo@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.com Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comDavid Heiberg Landsted+45 3077 6915dhel@novonordisk.comSina Meyer+45 3075 6656azey@novonordisk.comMark Joseph Root (US)+1 848 213 3219mjhr@novonordisk.comIda Schaap Melvold+45 3077 5649idmg@novonordisk.comFrederik Taylor Pitter+45 3075 8259fptr@novonordisk.com Company announcement No 58 / 2024 Attachment PR240807-Q2