Tag Archives: Fenix Analysis

Coming Soon: FENIX Obesity Spotlight Series

With the obesity market hot, FENIX is conducting a spotlight series throughout H1 2025 by deep diving into competitors’ portfolio approaches. The series will look to uncover key strategies that will shape the obesity market over the next 5-10 years from companies such as: Novo Nordisk, Lilly, AstraZeneca, Amgen, Boehringer Ingelheim, Roche, Merck, Regeneron, Pfizer, and others.

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Thoughts on Yescarta vs Kymriah Q1 2020 Sales Comparison

Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which reported a slight dip in Q1 2020 sales (see previous FENIX insight). Below, FENIX provides thoughts on published revenues and possible factors influencing HCPs’ CAR-T prescribing preferences.

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Novartis Oncology Q1 2020 Earnings Update

On Tuesday, April 28, Novartis held their Q1 2020 earnings call (press release / financial report / slides). Of note, Kymriah sales fell slightly versus the previous quarter (Q4 2019), possibly due to the impact of COVID-19. However, Novartis underlined its confidence in the oncology field’s “resilience” and the company’s full-year sales outlook. Below, FENIX provides thoughts on Novartis’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.

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New ADA/EASD Guidelines Recommend GLP-1RA Over Insulin and Make Other New H2H Drug Recommendations

ADA and EASD have updated their T2DM consensus guidelines (journal publication) with notable changes to the framework of the treatment algorithm (pictured below). Now, the algorithm takes a patient-centric approach and suggests a stepwise methodology based on the highest priority for the patient (ASCVD, CKD, hypoglycemia minimization, weight loss, and cost). Importantly, the guidelines recommend the use of GLP-1RA over insulin as the first injectable therapy as well as other in-class H2H drug recommendations. Below, FENIX provides a winners-and-losers analysis, highlights of the guideline updates, and how the identified knowledge gaps may be addressed.

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HARMONY @ EASD: Why You, AZ, and LLY, Should Care

With the upcoming Tanzeum CVOT (HARMONY Outcomes) presentation at EASD 2018 (Tues Oct 2 at 1200pm CET) and in the context of the DECLARE topline results and EXSCEL EU label update for Bydureon (previous FENIX insight), FENIX has conducted an analysis that describes the rationale where by HARMONY Outcomes could act as a potential catalyst for AZ to conduct their next large T2DM CVOT, either as GLP-1RA+SGLT2i or GLP-1/GCG dual-agonist on SGLT2i background therapy. In conjunction, FENIX has conducted a pieces-of-the-puzzle analysis that balances the likelihood HARMONY reads out positive for superiority at EASD.

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CREDENCE and CANVAS Filing Update & Implications

J&J hosted its pharmaceutical business review and provided a brief update on its diabetes business. J&J disclosed its intention to file CREDENCE in “2019”, which is later than initially projected by FENIX (late Q3 ’18 / early Q4 ’18). There was no discussion in the prepared remarks on the US review of CANVAS/R. Below, FENIX discusses a hypothesis where delaying the CREDENCE filing to 2019 could signal the CANVAS FDA discussions are going well and Invokana is likely to receive a CV protection indication.

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Zealand Lixi Royalty Sale May Indicate BD Challenges

Last week, Zealand sold its rights to Soliqua and Lyxumia future revenue streams to Royalty Pharma for $205M. While Zealand said it will use the funding to continue its pipeline progression, the sale could also indicate Zealand is having difficulty in some of its near-term business development initiatives, including finding a global commercialization partner for dasiglucagon in hypo rescue. Although speculative, it was likely easier for Zealand to sell its future Soliqua/Lyxumia royalty streams than to raise operational proceeds from the public markets. Below, FENIX provides thoughts on the sale and potential read-through to a dasiglucagon partnership.

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Thoughts on New Dapa HF CVOT (DELIVER)

Late last week, AZ announced a new HF CVOT for Farxiga named DELIVER. Curiously enough, the news was not seen on any global newswires. Below, FENIX provides its thoughts on the trial, including the checkered past of Scott Solomon and the choice of him as PI on DELIVER.

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Glucagon: Thoughts on Mylan Generic and Novel Launch Timings

The glucagon market for severe hypoglycemia rescue will be evolving in the near future with the anticipated filings of new ready-to-use products from Lilly and Xeris. However, the upcoming Mylan rescue product announced a few months ago will play a significant role in the rescue market ahead of the novel product launches. Below, FENIX provides a rich analysis on the potential timing of the upcoming glucagon rescue entrants from Lilly and Xeris, including also what Mylan’s product may or may not be.

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