EASD 2023 Key Press Releases (Oct 02)
On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external items):
On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external items):
Dexcom hosted its Q2 ‘23 earnings (press release; slides) and provided updates across its business. Of note, management highlighted that Dexcom had the highest YOY revenue growth recorded in company history at +26% ($871M) in Q2 ’23. As such, the company has increased its revenue guidance to $3.50-3.55B from $3.40-3.51B. Similar to commentary from Dexcom’s ADA 2023 investor event, management provided updates to the ongoing G7 US and OUS launches and reminded of plans to launch a 15-day sensor for people not on insulin in 2024 (previous FENIX insight). Below, FENIX provides highlights and insights from the call.
Five cardiometabolic-related news items have been observed: Lilly initiated three new trials in the Ph3 retatrutide obesity program, TRIUMPH (TRIUMPH-1; TRIUMPH-2; TRIUMPH-4); Zealand announced positive results from Part 1 of the Ph1 MAD trial evaluating its amylin analog, ZP8396 (view press release); Zealand also submitted the dasiglucagon NDA for congenital hyperinsulinism (view press release); Adocia signed an exclusivity agreement with Sanofi for M1Pram (view press release); and Dexcom’s G7 CGM received Health Canada approval for individuals aged 2 years and older (view press release). Below, FENIX provides highlights and insights into the respective news items, including a projected regulatory timeline for retatrutide and brief thoughts on next-gen obesity drugs.
In conjunction with the start of ADA 2023, Dexcom hosted its 2023 Investor Day (view slides) and provided updates across its business. Importantly, Dexcom disclosed plans to launch a CGM for people not on insulin in 2024 leveraging the G7 platform (view press release). Additionally, the company discussed the CGM opportunity in weight loss, pricing vs. Abbott Libre, updates to its 2025 long-range plan, and more (view press release). Below, FENIX provides highlights and insights from the Dexcom 2023 Investor Day, including thoughts on how the GLP-1RA weight loss hype has the potential to fuel CGM growth.
Four cardiometabolic-related news items have been observed: Dexcom (press release; slides), Amgen (press release; slides), and Merck (press release; slides) hosted their respective Q1 ’23 earnings calls; and JDRF and Humacyte announced a collaboration to advance the development of Humacyte’s Biovascular Pancreas (BVP) product candidate for the treatment of T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items.
Three cardiometabolic-related news items have been observed: Lilly announced that it will invest an additional $1.6B and add another 200 jobs to its new manufacturing sites within LEAP Innovation Park in Boone County, Indiana (view press release); Dexcom (view press release) and Abbott (view press release) separately issued statements regarding CMS’s decision to expand Medicare coverage for T2DM, including certain non-insulin-using individuals; and Tandem Diabetes announced that Diabetes Technology & Therapeutics published a meta-analysis of three Control-IQ AID trials (view press release; publication). Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items were observed from Insulet, Bigfoot, Dexcom, Novo Nordisk, and Sanofi. Below, FENIX provides highlights and insights into the respective news items.
Dexcom Q4 ’22 and FY ‘22 earnings update
Two cardiometabolic-related news items have been observed: Vertex hosted its Q4 ‘22 earnings call and provided brief updates to its ongoing T1DM cell-therapy programs (press release; slides); and Dario announced an agreement with Dexcom to integrate Dexcom CGMs into Dario’s multi-chronic condition platform (view press release). Below, FENIX provides highlights and insights into the respective news items.
Four cardiometabolic-related news items have been observed: Dexcom announced plans for a second Super Bowl DTC for the G7 CGM US launch (view press release; commercial); Medtronic initiated a trial evaluating the MiniMed 780G insulin pump used in combination with the DS5 CGM (Simplera) as well as the Medtronic extended infusion set and reservoir (view CT.gov record); Forxiga (dapagliflozin) has received EU approval to expand its HF indication regardless of LVEF (view Forxiga EPAR); and Merck initiated a Ph2/3 trial evaluating the vericiguat in pediatric patients aged 28 days to 18 years (VALOR; view CT.gov record). Below, FENIX provides highlights and insights from the respective news items including commentary on how the Medtronic study could suggest the company may not believe it can achieve iCGM designation.