Category Archives: Topics

Senseonics Q3 ’18 Earnings Update; Abbott FreeStyle Link Now Available

Senseonics hosted its Q3 ’18 earnings call and provided updates on the Eversense implantable CGM launch as well as pipeline activities. Additionally, Abbott recently announced the approval of Libre Link, an app that allows users to scan the Libre device with their iPhone. Below, FENIX provides thoughts on the Eversense launch, ongoing negotiations with Roche, and the potential impact of the Libre Link to accelerate Libre adoption.

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Xeris to Launch Stable Glucagon in H2 ’19

In Xeris’s Q3 ’18 10-Q SEC filing, the company disclosed plans to launch its stable glucagon pen for hypoglycemia rescue in H2 ’19, which is later than previously projected by FENIX. Recall, Xeris recently stated that the FDA PDUFA date is on June 10, 2019. Below, FENIX explores potential reasons for the later-than-anticipated launch as well as key exhibition opportunities for Xeris.

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Farxiga T1DM US Filing in Q4 ’18; AZ Q3 ’18 Earnings Update

AZ hosted their Q3 ’18 earnings call (press release) and briefly discussed their diabetes portfolio. Of note, AZ disclosed it plans to file Farxiga for a T1DM indication in Q4 ’18. Previously, AZ had been quiet regarding the US Farxiga T1DM filing during Q2 ’18 earnings. Furthermore, full results from the Farxiga CVOT, DECLARE, are being presented at the AHA conference on November 10, 2018. Below, FENIX provides thoughts on the potential DECLARE indication, Farxiga T1DM filing timing, and other highlights from the call. Farxiga CVOT (DECLARE) Filing Given the upcoming DECLARE data presentation at AHA, AZ senior management only……

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Insulet Partners with Samsung for Smartphone Pump Control

Insulet announced a partnership with Samsung to allow for control of the Omnipod through a Samsung Galaxy smartphone. The specific Samsung device has not been disclosed. Below, FENIX provides thoughts on why a partnership with a single smartphone manufacturer makes sense from a regulatory standpoint.

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Xeris Q3 ’18 Earnings Update

Xeris released its Q3 ’18 earnings (press release) and provided updates to its glucagon activities including the recent FDA filing acceptance (PDUFA June 10, 2019). Below are highlights from the earnings release.

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New Dexcom Approvals; Dexcom and BD Q3 ’18 Earnings Updates

Dexcom and Becton Dickinson hosted Q3 ’18 earnings calls and provided updates to their respective businesses. Of note, Dexcom discussed two new 510(k) clearances based on the G6 iCGM regulatory pathway. Furthermore, BD said it has discontinued development of the FlowSmart infusion set in favor of other opportunities, notably the T2DM patch pump which is projected to file “in the coming months.” Below FENIX provides thoughts on how Dexcom is anticipated to leverage these new approvals for future product development and market shaping.

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REWIND Safety Issue? Lilly Q3 ’18 Earnings Update

Lilly hosted its Q3 ’18 earnings call and provided updates to its diabetes business including commentary on the recent REWIND topline results. Of note, Lilly’s first Ph3 study for its GIP/GLP dual agonist, now called tirzepatide, has been posted on CT.gov. Furthermore, Lilly said it has purchased a priority review voucher (PRV), but did not disclose how it will be used. Below, FENIX provides its new thoughts on REWIND safety, why Lilly’s PRV would be used for REWIND, and other key highlights from the earnings call.

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Mylan Q3 ’18 Earnings Update

Mylan hosted its Q3 ’18 earnings call (press release) and briefly discussed its bs-glargine. In response to an analyst’s question regarding Merck/Samsung discontinuing glargine development, Mylan affirmed they believe they can launch bs-glargine and still maintain adequate margins. Furthermore, Mylan senior management stated that they are continuing to work with FDA to find a path forward for a substitutable product.

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Positive Trulicity CVOT Creates Many Market Implications

Lilly announced positive topline results from the Trulicity CVOT, REWIND, demonstrating a reduction in 3P-MACE in a patient population which included ~70% primary prevention. Of note, Lilly did not provide any Hazard Ratios so the amount of CV protection remains unclear. Below, FENIX provides thoughts on the potential impact to guidelines and the GLP-1RA market if FDA grants a broader CV indication (reduction in 3P-MACE in T2DM patients with CV risk factors) than the Victoza, Jardiance, and Invokana labels.

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