Dexcom hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its CGM business. Of note, Dexcom has continued to show significant revenue growth, reaching total topline sales of nearly $1.5B in 2019 (+43% YOY). Below, FENIX provides highlights and insights from the earnings call including a Dexcom comment on Lilly’s smartpen launch.
Senseonics announced a new partnership with Companion Medical to integrate Eversense implantable CGM data into the Companion Medical InPen platform. Additionally, Nemaura Medical issued a press release for its FY Q3 ’19 (CY Q4 ’19) earnings. Below, FENIX provides thoughts on the partnership including why it makes sense for both Senseonics and Companion Medical.
A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. Below, FENIX provides highlights and insights for the respective news items.
CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.
Approximately 1 week after i-SENS received 510(k) clearance for the Caresens S Fit BT BGM, FDA has cleared another i-SENS Bluetooth BGM called “Caresens S Clear BT.” Below, FENIX provides brief thoughts on the new i-SENS BGM.
A series of diabetes-related news items have been observed including Gan & Lee completed a Ph1 biosimilarity study for its glargine, earnings calls from Johnson & Johnson and Abbott, Medtronic initiated a new advanced hybrid closed-loop study, and Biocon received tentative approval for generic dapagliflozin. Below, FENIX provides diabetes-related highlights and insights from the calls including thoughts on how the G&L study appears to be in-line with FDA’s thinking on biosimilar insulins.
A series of diabetes-related news has been observed including the 510(k) clearance for a new i-SENS BGM (believed to have Bluetooth connectivity), Integrity Applications received CE Mark for its non-invasive glucose meter, Livongo is now available to Horizon BCBS NJ, and Oramed appointed Jay Skyler to its scientific advisory board. Below, FENIX provides highlights and insights related to the respective news items.
On the first day of JPM 2020, FENIX has provided coverage of presentations by major diabetes manufacturers including Dexcom, Medtronic, Teva, J&J, and Merck. Additionally, four separate diabetes-related news items have been observed including new collaborations between Dexcom/Livongo and Novo Nordisk/Fauna Bio as well as funding rounds from Companion Medical and Bigfoot Biomedical. Below, find a topline summary of key takeaways by company followed by more in-depth coverage.
Two diabetes-related connected care news items have been observed. First, Livongo announced it has partnered with Higi to make Livongo for Diabetes and Livongo for Hypertension available at Higi’s “Smart Health Stations.” Additionally, Dario Health appointed Rick Anderson as the company’s new President and General Manager of North America. Below, FENIX provides thoughts and insights into the respective news items.
ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.