Insulet hosted its Q2 ’18 earnings call and provided updates on its Omnipod business including pipeline activities for the Omnipod Horizon hybrid closed-loop. Below are highlights from the call.
Becton Dickinson hosted its CY Q2 ’18 Earnings (FY Q3 ’18) call and provided an update on the development of their T2DM patch pump, called Swatch. BD plans to file the device in both the US and EU later this year with an initial limited launch in late FY 2019 (CY Q3 ’19). Below, FENIX provides further details into the BD Swatch pump and insight into its impact to the T2DM market.
Tandem hosted its Q2 ’18 earnings call and provided updates to its insulin pump business including its closed-loop R&D programs. Tandem has scheduled an institutional investor day for September 25, 2018 where it will provide further updates on its pipeline and international business.
Roche hosted its Q2 ’18 earnings call and briefly discussed its diabetes devices portfolio including Solo micropump, which recently received CE Mark. Importantly, Roche senior management disclosed their intentions to bring the Solo micropump to the US. Below are highlights from the call including insights from Roche’s recent collaboration and investment in Care Innovations.
Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).
Roche has received CE Mark for the Accu-Chek Solo micropump. Recall, during Roche’s Q4 ’17 earnings call, the company added the Solo micropump to its European launch timeline. The device had been noticeably absent in recent years. In the coming weeks, Roche will initiate a limited pilot launch starting in Austria, Poland, Switzerland, and the UK. Below, FENIX provides insight into the Solo micropump including its potential use in a closed-loop system.
J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings call.
CeQur announced it has acquired global rights to commercialize the OneTouch Via patch pump. CeQur’s interest in OneTouch Via is curious since CeQur has developed its own patch pump (PaQ). According to the press release, CeQur plans to launch the OneTouch Via (branded under a new, undisclosed name) in mid-2019. Below, FENIX provides thoughts on whether CeQur will commercialize both devices as well as insight into the T2DM pump market.
Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon market.
Sensile Medical is reportedly being acquired by Gerresheimer, a German company specializing in manufacturing packaging and drug delivery systems.