Tag Archives: Dexcom ONE

July CHMP Agenda; MiniMed 780G CE Mark for Expanded Indication; Dexcom Receiver Recall

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (July 21-24) has been released (view here); Medtronic announced its MiniMed 780G pump received CE Mark for ages 2+ years of age, T2DM, and during pregnancy (view press release); and FDA announced Dexcom’s CGM receivers have been recalled for faulty alert sounds (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s EU semaglutide MASH regulatory strategy.

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Dexcom Q1 ’24 Earnings

Dexcom hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its business. Unsurprisingly, much of the prepared remarks and Q&A portions of the call were dedicated to Stelo and the impending launch in Summer 2024. Below, FENIX provides highlights and insights from the call.

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Dexcom Q4 ’23 and FY ’23 Earnings

Dexcom hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its business, including the impending Stelo CGM launch for T2DM patients not on insulin. Below, FENIX provides highlights and insights from the call.

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Amgen, Arrowhead, and Vertex Q4 ‘23 Earnings; Dexcom Launches Dexcom ONE+; O5 Receives CE Mark for Libre 2 Plus Integration; Brian Hansen Appointed Ascensia CGM President; Scholar Rock Preclinical Data for Obesity

A series of cardiometabolic-related news items have been observed from Amgen, Arrowhead, Dexcom, Insulet, PHC Holdings and Senseonics/Ascensia, Vertex, and Scholar Rock. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2024 Day 1: DXCM, MDT, AMGN, AKERO, ARWR, CYTO, NVS, VRTX, ALN, REGN; Tandem X2 Control-IQ Integrated with Libre 2 Plus; Supersapiens Launches Diabetes Platform; Novo Ph3 Icosema Results

On the first day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Medtronic, Amgen, Akero, Arrowhead, Cytokinetics, Novartis, Vertex, Alnylam, and Regeneron. Pfizer and Merck also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: Tandem and Abbott announced the Tandem X2 Control-IQ AID system now integrates with Abbott’s Libre 2 Plus CGM (view press release); Novo announced topline results from the COMBINE 3 study evaluating icosema vs. basal-bolus treatment in T2DM (view press release); and Supersapiens announced the launch of its Supersapiens Diabetes platform (view post).

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Dexcom Q3 ’23 Earnings

Dexcom hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its business. Of note, Dexcom’s stock price increased approximately +15% in after-hours trading due to the positive quarterly performance. Below, FENIX provides highlights and insights from the call.

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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):

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Entera Bio to Collaborate with OPKO Biologics for Obesity; Dexcom Launches Dexcom ONE in France; Altimmune Completes Ph2 Obesity Trial Dosing; Vertex Acquires Novel GPCR-targeted Program

Four cardiometabolic-related news items have been observed: Entera Bio and OPKO Biologics entered into a research collaboration agreement for OPKO’s long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs (view press release); Dexcom announced Dexcom ONE has been launched in France (with reimbursement) for patients two years of age and older with T1DM and T2DM, who are undergoing intensive insulin therapy (view press release); Altimmune announced the completion of dosing in its 48-week Ph2 MOMENTUM trial, evaluating the safety and efficacy of pemvidutide in patients with obesity or overweight (view press release); and Septerna announced it signed a definitive asset purchase agreement with Vertex for an undisclosed discovery-stage GPCR program (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Dexcom Q2 ’23 Earnings

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.

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Dexcom to Ride the Obesity Wave; Dexcom 2023 Investor Day

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.

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