Tandem Diabetes Care hosted its Q2 ’20 earnings call (press release) and provided updates to key commercial and clinical activities including its curious partnership with Medtronic (previous FENIX insight), t:connect app launch, partnership with Abbott, and more. Below, FENIX provides highlights and insights from the call.
On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel’s potential approval, and the possible benefit a delayed ide-cel launch could have for Janssen.
Lilly (press release; slides), AstraZeneca (press release; slides), and Lexicon (press release; slides link unavailable) hosted their respective earnings calls. Importantly, BI/Lilly announced positive topline results from the EMPEROR-Reduced outcomes trial in HFrEF patients with and without T2DM, AZ discontinued its small molecule GLP-1RA (MEDI7219), and Lexicon is restructuring its business to shift focus toward R&D. Below, FENIX provides insights into the EMPEROR-Reduced results in the context of the evolving SGLT2i HF market as well as thoughts on how Lexicon’s restructuring could be an indicator for the sotagliflozin CVOT results.
On Friday, July 17, BMS announced (press release) that the EMA has validated BMS’s MAA for lisocabtagene maraleucel (liso-cel). Below, Celltelligence provides thoughts on Liso-cel’s MAA and the potential impact of a Liso-cel approval for Novartis and Gilead (Kite).
Abbott has officially launched its Libre 2 CGM in the US, although the website (view here) has not yet been updated at the time of this publication. Of note, Abbott disclosed the Libre 2 App remains under review by FDA, suggesting the user must purchase the dedicated reader. Below, FENIX provides an excerpt from the Libre 2 launch email as well as brief thoughts on how the lack of a Libre 2 App could impact the initial launch.
Sanofi hosted its Q2 ’20 earnings call (press release; slides) and provided a brief update to its diabetes business in the context of the continued decline in glargine revenue. Unsurprisingly, the vast majority of the call was dedicated to Dupixent performance and Sanofi’s preparation for the upcoming flu season. Below, FENIX provides a financial summary of the diabetes portfolio and insights from the call.
Dexcom (press release; slides) and Pfizer (press release; slides) hosted their Q2 ’20 earnings calls and provided updates to their respective diabetes businesses. Despite COVID-19, Dexcom posted a +34% YOY performance and disclosed that T2DM patients now make up ~20% of its total installed base. Below, FENIX provides highlights and insights from the calls.
AstraZeneca announced positive topline results from the Ph3 DAPA-CKD trial evaluating the effect of dapagliflozin on renal and CV outcomes in CKD patients with and without T2DM (view CT.gov record). According to the press release, Farxiga met all primary and secondary endpoints including all-cause mortality; however, no specific data was provided. Recall, DAPA-CKD was stopped at the end of March ~8 months early due to overwhelming efficacy (previous FENIX insight). Below, FENIX provides thoughts on the topline results ahead of the July 30 earnings call and in the context of the Invokana CREDENCE renal protection indication, the impending results from BI/Lilly’s EMPA-KIDNEY study, and Bayer’s FIDELIO-DKD outcomes trial for finerenone.
Nemaura Medical announced it has entered into a letter of intent with Healthimation “relating to a possible acquisition of the Healthimation business by Nemaura.” For context, Healthimation (view website here) is a healthcare animation company that has developed an interactive weight loss management program called “Why WAIT” based on the Joslin weight loss program of the same name. Below, FENIX provides insight into the potential Nemaura acquisition and thoughts on how Healthimation may act more to attract new patients than actually drive outcomes.
Biocon hosted its CY Q2 ’20 earnings call (FY Q1 ’21) and provided updates to the business including its biosimilar insulins portfolio (view press release). Of note, Biocon Biologics CEO Christiane Hamacher commented that the recent Voluntis “…digital therapeutic is not a nice to have, it’s a must-have.” Below, FENIX provides an updated perspective on the Biocon/Voluntis partnership, including thoughts on how the partnership may signal that Biocon could have altered its bs-insulin strategy.