BD hosted their CY Q2 ’19 (FY Q3 ’19) earnings call (press release) and provided a brief update on their diabetes business unit including the 510(k) withdrawal of their Swatch pump for T2DM. Below, FENIX provides further details on the Swatch pump 510(k) withdrawal and insight into its impact on the T2DM patch pump segment.
Insulet hosted its Q2 ’19 earnings call and provided updates to its commercial and pipeline activities including the Omnipod Horizon hybrid closed-loop development. Below are highlights and insights from the call.
Today, three key news items were observed including the Forxiga DECLARE EU approval, Breakthrough Therapy Designation to Provention Bio’s Teplizumab (PRV-031) and a MannKind/ One Drop collaboration. Below, FENIX provides context and analysis for these announcements.
Lilly has initiated SURPASS-5 (add-on to glargine) which is the 5th and final tirzepatide pivotal Ph3 trial for T2DM. Below, FENIX provides an overview of SURPASS-5 as well as insight into why the study is likely using background glargine U100 and not all basal insulins as well as a high-level comparison between SURPASS-5 and the Trulicity AWARD-9 study.
A new Jardiance TV DTC commercial, called “Audrey is on it,” has been observed. Of note, the commercial is set to the tune of the 1981 hit “Apache (Jump on it)” by the Sugarhill Gang, potentially in response to the success of other T2DM commercials that have also used jingles (Ozempic, Farxiga, and Tresiba). Below, FENIX provides analysis of the Jardiance TV commercial including insight on how the commercial’s football/marching band theme is apropos leading into the NFL and college football seasons.
Tandem Diabetes Care hosted its Q2 ’19 earnings call and provided updates to its t:slim pump business. Additionally, Tandem announced that all software updates through YE 2020 will be provided free to users with in-warranty pumps. Below, FENIX provides highlights and insights from the call.
Yesterday, ADA announced updates to its Living Standards of Medical Care in Diabetes. The Living Standards of Care revision now incorporates REWIND CV data, Victoza use in pediatric patients, and the international consensus report on CGM time-in-range goals. Below, FENIX provides thoughts and market implications for each of the respective guideline updates.
Dexcom hosted its Q2 ’19 earnings call and provided updates to its R&D and commercial activities including G7 CGM launch preparations. Below, FENIX provides highlights and insights from the earnings call.
Lexicon hosted its Q2 ’19 earnings call and provided updates to its business including commentary on Sanofi’s recent decision to end the sotagliflozin partnership. Below, FENIX provides highlights and insights from the call.
Merck hosted its Q2 ’19 earnings call but did not provide any updates to its diabetes business beyond the Januvia and Steglatro financial performances. Unsurprisingly, the vast majority of the discussion was focused on Merck’s oncology and HIV portfolios. Below, FENIX provides diabetes-related highlights from the call.