Category Archives: Topics

Negative Entresto Adcom Could Renew Interest in Sotagliflozin – Lexicon and Sanofi Q3 ’20 Earnings Updates; Lifescan Partners for Diabetes Coaching

Lexicon (press release) and Sanofi (press release; slides) hosted their respective Q3 ’20 earnings calls and provided updates to their diabetes businesses. Additionally, Lifescan announced a partnership with Cecelia Health to provide coaching and telehealth services to OneTouch users. Below, FENIX provides highlights and insights from the respective news items, including how the upcoming Entresto FDA adcom could renew M&A interest in Lexicon.

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Teladoc and Livongo Q3 ’20 Earnings Updates

Teladoc hosted its Q3 ’30 earnings call (press release) and provided updates to its business, including the impending merger with Livongo. Separately, Livongo issued a press release regarding its Q3 ’20 earnings, but the company did not host an associated call with investors due to the Teladoc merger. Below, FENIX provides highlights and insights from the respective earnings releases.

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Dexcom G7 Reduced Wear Time; Q3 ’20 Earnings Update

Dexcom hosted its Q3 ’20 earnings call (press release) and provided updates to its clinical and commercial activities, including the impending filing/launch of the G7 CGM. Importantly, Dexcom disclosed G7 will now be launched with a 10-day wear time instead of 15 days, and a virtual investor event will take place on December 9, 2020. Below, FENIX provides highlights and insights from the call.

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Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.

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Lifescan Partners with Truepill to Expand eCommerce Presence

Lifescan announced it has entered into a partnership with Truepill (view website) in an effort to “expand [Lifescan’s] OneTouch brand offerings beyond diabetes testing supplies to innovative digital wellness offerings for diabetes and related health conditions, including weight loss, fitness, and hypertension.” For context, Truepill was founded in 2016 with the intention of creating the first pharmacy API. Now, the company has expanded to offer other solutions including telehealth services. According to the press release, the companies will launch an eCommerce platform in November 2020 which will be integrated with the OneTouch Reveal mobile app. Below, FENIX provides insight into the new partnership, including thoughts on how COVID-19 may have hastened Lifescan’s strategic move.

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Biocon CY Q3 ’20 (FY Q2 ’21) Earnings Update

Biocon hosted its CY Q3 ’20 earnings call (FY Q2 ’21) and provided updates to its biosimilar insulin portfolio. Unsurprisingly, much of the call was focused on COVID-19 treatments and the US Semglee (biosimilar glargine U100) launch. Of note, there was no mention of the biosimilar lispro or oral insulin tregopil programs. Below, FENIX provides highlights and insights from the call, including an analysis of the US Semglee weekly NRx.

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FIDELIO Demonstrates 18% RRR; DAPA-CKD and EMPEROR-Reduced Sub-Analyses

On the second day of Kidney Week 2020, three notable data sets were released: Bayer’s FIDELIO-DKD study demonstrated an 18% RRR in the primary composite endpoint (view press release; view NEJM publication); AstraZeneca presented a DAPA-CKD sub-analysis that demonstrated a reduction in the composite endpoint irrespective of the underlying CKD cause (view press release); BI/Lilly presented an EMPEROR-Reduced sub-analysis showing no difference in CV/renal outcomes regardless of baseline CKD (view press release). Below, FENIX provides highlights and implications of the data with a particular focus on FIDELIO.

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New AZD9977 + Dapa Ph2b Trial in HF+CKD (MIRACLE)

A CT.gov record has been observed for a new Ph2b trial evaluating AZD9977, a novel mineralocorticoid receptor modulator (MCR), as add-on to dapagliflozin in patients with HF and CKD. The trial initiation is in-line with AZ’s commentary from its Q2 ’20 earnings call (previous FENIX insight). Of note, John McMurray is the PI for the MIRACLE trial. McMurray previously served as the PI for DAPA-HF and a member of the executive committee for DAPA-CKD. Below, FENIX provides an overview of the MIRACLE trial as well as why AZ’s pursuit of accelerated approval for AZD9977 could make sense.

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