Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. Below, FENIX provides highlights and insights from the call.
At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.
Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. Below, FENIX provides highlights and insights from the call.
As a follow-up to Novo’s oral semaglutide ASCEND PLUS primary prevention CVOT being posted to CT.gov (previous FENIX insight), FENIX has conducted an analysis, including thoughts on how Novo may be looking to displace metformin as 1L oral treatment for T2DM.
A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. Below, FENIX provides highlights and insights from the respective news items.
Novo Nordisk announced it is facing new Wegovy supply challenges in the US, and Novo will not be able to meet demand through H1 ’22. Novo said it will prioritize patients who have already initiated Wegovy treatment. According to the press release, the contract manufacturer has temporarily stopped deliveries and manufacturing due to “issues with Good Manufacturing Practices.” Novo plans to host a call with investors on December 20, 2021 to further discuss the Wegovy supply issue. Below, FENIX provides brief thoughts on the impact to the Wegovy launch.
Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. Below, FENIX provides highlights and insights from the call.
There have been no cardiometabolic press releases observed yet on the second day of ADA 2021. However, it appears that Novo Nordisk has recently launched the Wegovy patient website. Of note, the HCP website is not yet live as the wegovypro.com URL redirects to NovoMedLink. Below, FENIX provides an analysis of the Wegovy patient website and insights as to when to expect a DTC campaign launch.
A series of cardiometabolic news items have been observed: Evernorth announced the expansion of its Weight Management Care Value program to include Novo Nordisk’s Wegovy (2.4mg semaglutide); a new Novo-sponsored trial, referred to as STEP HFpEF DM, has been observed evaluating semaglutide in people living with HF, obesity, and T2DM; JDRF issued an RFA for the development of combination CGM + continuous ketone monitoring (CKM) devices for the use of preventing DKA in patients with T1DM; and One Drop announced it has surpassed 25B longitudinal biometric data points in its platform. Below, FENIX provides highlights and insights for the respective news items.
As a follow up to FENIX’s Wegovy label analysis from yesterday, FENIX provides additional thoughts on the Wegovy WAC pricing vs. Saxenda. According to Novo Nordisk’s pricing websites, both Wegovy and Saxenda are being offered at the same WAC of $1,349.02. However, since a 4-pen pack of Wegovy is for 28 days and a five-pen pack of Saxenda is for 30 days, the daily cost of Wegovy is slightly higher than that of Saxenda (see table below). Below, FENIX provides insight on why Novo would offer a premium product near pricing parity with its predecessor.