Category Archives: Topics

Lilly Q3 ’19 Earnings Update; Conterno to Retire

Lilly hosted its Q3 ’19 earnings call (press release) and provided updates across its diabetes business. In a separate press release, Lilly disclosed that its current senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, Enrique Conterno, will be retiring at the end of the year. Mike Mason, current SVP of Connected Care and Insulins, will succeed Conterno. During the earnings call, Lilly also highlighted Ph1 development of its triple-agonist and oral GLP-1 non-peptide agonist, Jardiance LCM, the recent positive CHMP opinion for Baqsimi, and Trulicity pricing dynamics. Below, FENIX provides context and insights from the call.

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Thoughts on Medtronic Diabetes Leadership Change

Medtronic announced it has replaced Hooman Hakami as the head of its diabetes division with Sean Salmon, the former Senior Vice President and President of Medtronic’s Coronary and Structural Heart business. Below, FENIX provides brief thoughts on the change in Medtronic leadership and the potential impact to the diabetes business.

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Fiasp Approved for Pump Use in US

Novo Nordisk announced FDA approved Fiasp pump compatibility in adults with T1DM and T2DM. According to Novo, the updated label is based on data from the Onset 5 clinical trial (CT.gov record). Recall, Onset 5 demonstrated non inferiority in the primary outcome measure of change in A1C, but failed to show superiority. Below, FENIX provides context and insight surrounding the approval, including read-through to Lilly’s ultra rapid-acting insulin lispro (URLi).

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Thoughts on DECLARE FDA Approval

AstraZeneca announced FDA approved a Farxiga heart failure indication in T2DM patients based on results from the DECLARE CVOT. Below, FENIX provides a DECLARE label analysis as well as potential market implications to the SGLT2i class particularly ahead of the DAPA-HF FDA filing/approval.

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Abbott Acknowledges Libre 2 Delay; Abbott and Roche Q3 ’19 Earnings Updates

Abbott and Roche hosted their respective Q3 ’19 earnings calls and provided updates to their diabetes businesses. Of note, Abbott confirmed that Libre 2 US approval is delayed from initial expectations, and Abbott indicated they are working through several items with FDA. Below, FENIX provides highlights and insights from the respective calls.

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Abbott and Tandem partnership; Livongo partners with VSP Vision Care

Abbott and Tandem Diabetes Care announced plans to develop an integrated diabetes solution utilizing Abbott’s glucose monitoring sensors (Libre) and Tandem’s insulin delivery systems. Additionally, Livongo and VSP Vision Care announced a partnership to expand eye care outreach efforts to Livongo members with diabetes. Below, FENIX provides context and broader implications on these partnerships.

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J&J Q3 ’19 Earnings Update

Johnson & Johnson hosted their Q3 ’19 earnings call (press release) and briefly discussed the Invokana franchise. Of note, J&J only briefly mentioned the recent Invokana DKD approval based on results from the CREDENCE trial. Below, FENIX provides highlights and diabetes-related insights from the call.

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Abbott Partners with Omada; New Senseonics BCBS Coverage; Adocia Receives €15M in Funding; Roche Partners with iHeartMedia

Today, three major news items were observed covering a new partnership between Abbott and Omada Health, Senseonics Eversense new BCBS coverage decision, €15 million in financing for Adocia, and a Roche/iHeartMedia diabetes awareness concert. Below, FENIX provides thoughts and analysis for each respective news item.

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Abbott Libre 2 US Approval Conspicuously Late?

The FDA approval of Abbott’s next-generation CGM, Libre 2, appears to be conspicuously late, which has created questions as to what the potential issue could be. Below, FENIX provides evidence and hypotheses surrounding the delayed Libre 2 US approval. See the full blast for more details on our 3 hypotheses.

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