Category Archives: Topics

Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. Below, FENIX provides highlights and insights from the call.

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Lilly Q2 ’21 Earnings Update

Lilly hosted its Q2 ’21 earnings call and provided updates across its CV/Met portfolio, specifically for tirzepatide and Jardiance. Unsurprisingly, much of the call focused on donanemab for the treatment of Alzheimer’s disease following FDA’s June 2021 approval of Aduhelm (aducanamab) for the same treatment. Of note, Lilly disclosed it intends to host an in-person investor event in December 2021 to provide pipeline updates and initial guidance. Below, FENIX provides highlights and insights from the Lilly earnings call.

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Lexicon, Merck, and Intercept Q2 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Lexicon, Merck, and Intercept hosted their Q2 ’21 earnings calls and provided updates to their respective CV/Met businesses. Below, FENIX provides highlights and insights for the calls.

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Dexcom Q2 ’21 Earnings Update

Dexcom hosted its Q2 ’21 earnings call and provided updates to its clinical and commercial activities, including the G7 OUS launch anticipated later in 2021. Below, FENIX provides highlights and insights from the call.

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Semglee (Bs-glargine) Receives US Interchangeability; Sanofi Q2 ’21 Earnings Update

Two diabetes-related news items have been observed: Viatris and Biocon announced FDA approval of Semglee (bs-glargine) as the first interchangeable biosimilar insulin product under the 351(k) regulatory pathway; and Sanofi hosted its Q2 ’21 earnings call and provided a brief update to its diabetes business. Below, FENIX provides highlights and insights from the respective news items.

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AZ Q2 ’21 Earnings Updates

AstraZeneca hosted its Q2 ’21 earnings call, and once again, much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development and oncology portfolio. Below, FENIX provides highlights and insights from the call.

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Lifescan and Noom Expand Partnership; Supersapiens Adds Zisser and Ketchell to Leadership Team; Teladoc, Pfizer, and Teva Q2 ’21 Earnings Update

A series of cardiometabolic-related new items have recently been observed: Lifescan and Noom announced an expanded partnership focused on Noom’s Diabetes Support Program; Supersapiens announced the addition of Howard Zisser and Robby Ketchell to the company’s executive team; Teladoc (press release; slides), Pfizer (press release; slides), and Teva (press release; slides) hosted their respective Q2 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective news items.

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AZ and Regeneron Collaborate on Obesity Treatment Development

AstraZeneca and Regeneron announced a collaboration for the research, development, and commercialization of small molecule compounds against the GPR75 gene to treat obesity and related comorbidities. For context, genetic mutations in GPR75 have been linked to patients having a lower BMI and experiencing a 54% lower risk of obesity than those without the mutation. According to the press release, AZ and Regeneron will evenly split the research and development costs as well as any future profits.

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Finerenone Label and Website Analysis

Bayer recently announced 10mg and 20mg finerenone, branded as “Kerendia,” received FDA approval. The approval of finerenone is based on the positive results of the FIDELIO-DKD study which demonstrated an 18% RRR in the primary composite endpoint. Below, FENIX has conducted a Kerendia label and website analysis.

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