Tag Archives: Senseonics

Senseonics Files 180-Day Implantable CGM sPMA; Beyond Type 1 Launches Insulin Affordability Resource; KDIGO Releases New 2020 T2DM+CKD Guidelines

A series of diabetes-related news items have been observed: Senseonics announced the sPMA filing of its 180-day implantable CGM; Beyond Type 1 launched GetInsulin.org as a tool to connect PWD to insulin assistance programs and low-cost insulin solutions (press release); and Kidney Disease: Improving Global Outcomes (KDIGO) recently released its first-ever T2DM CKD guidelines, called 2020 Clinical Practice Guideline for Diabetes Management in CKD (view press release; view complete document here). Below, FENIX provides highlights and insight from the respective news items.

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Senseonics Hosts Investor Event with Special Guest Ascensia

Today, Senseonics hosted a virtual investor event that also included a guest spot by Ascensia President, Robert Schumm. The goal of the event was to provide further detail to help inform financial analyst valuation models for SENS following the August 2020 partnership with Ascensia. Below, FENIX provides a summary and context from the information-rich event.

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Libre 2 Available for Medicare Patients; Senseonics Receives Positive Medicare Local Coverage Determinations

Abbott announced its Libre 2 CGM system is now available for Medicare patients. Additionally, Senseonics announced that three Medicare Administrative Contractors (MACs) issued Local Coverage Determinations for the use of implantable CGMs. Below, FENIX provides insight into the Abbott and Senseonics Medicare news, including thoughts on how Abbott is more likely to benefit than Senseonics/Ascensia due to the ongoing COVID-19 pandemic.

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Ascensia Takes Over WW Eversense CGM Distribution; Xeris and Senseonics Q2 ’20 Earnings Update; Precigen ActoBio Announces Positive Topline Results for T1DM Modulator

Four diabetes-related news items have been observed: Ascensia announced a strategic partnership with Senseonics for world-wide commercialization and distribution of the Eversense implantable CGM; Senseonics hosted its Q2 ’20 earnings call (press release), Xeris hosted its Q2 ’20 earnings call (press release), and Precigen ActoBio announced positive topline results from its Ph1b study of AG019 for the treatment of early-onset T1DM. Below, FENIX provides highlights of the respective news items, including thoughts on the curious partnership between Ascensia and Senseonics in the context of the existing partnerships between Senseonics/Roche and Ascensia/POCTech.

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Libre 2 US Approval Was Worth the Wait for Abbott, but Not Its Pump Partners

Abbott announced FDA approval of the Libre 2 iCGM in patients 4 years of age and older; however, the initial approval comes without closed-loop compatibility. According to FDA’s 510(k) database, Libre 2 was approved on Friday, June 12, but FDA typically doesn’t update the database until Monday. Recall, Libre 2 approval had been delayed for undisclosed reasons, but FENIX recently anticipated a near-term US approval with the closure of Bigfoot’s Series C (previous FENIX insight). Below, FENIX provides thoughts on the Libre 2 approval, a comparative analysis with the Dexcom G6, and potential implications to other CGM manufacturers including Medtronic, Senseonics, Lifescan, Waveform, and Nemaura.

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Senseonics Q1 ’20 Earnings Update

Yesterday, Senseonics hosted its Q1 ’20 earnings call (press release) and provided updates to its business including the company’s new strategic priorities following the suspension of its commercial activities. Importantly, Q1 ’20 net revenue fell to $36k compared to $3.4M in Q1 ’19. Below, FENIX provides highlights and insights from the call.

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Dexcom Q1 ’20 Earnings Update; Dexcom G7 CGM Delayed; Eversense MRI Safety Approval in EU

Dexcom hosted its Q1 ’20 earnings call and provided updates to its diabetes business, including a disclosure that the company had a record number of new patient starts in Q1 ’20. Separately, Senseonics announced it received conditional approval for use of Eversense implantable CGMs while patients undergo MRI procedures. Below, FENIX provides highlights and insights from the call including thoughts on Dexcom’s COVID-19 response.

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Roche Q1 ’20 Earnings Update; SENS Secures $20M from a New Credit Facility

Two diabetes-related news items have been observed: Roche hosted its Q1 ’20 earnings call and provided updates to its diabetes business, and Senseonics secured a $20M new credit facility with certain funds managed by Highbridge Capital Management, LLC. Below, FENIX provides highlights from the call and thoughts on Senseonics’ current financial position.

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Senseonics Suspends US Commercial Sales to New Patients

In a recent 8K SEC filing, Senseonics disclosed that it will no longer ship Eversense implantable CGMs to new customers in the US; however, the company intends to maintain supply for existing customers. The news comes just days after Senseonics announced plans to explore strategic options for the company, including a potential sale. Below, FENIX provides additional thoughts on Senseonics’s current position.

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Senseonics Exploring Strategic Alternatives

Senseonics announced today that the company is exploring strategic alternatives, including a potential sale. Below, FENIX provides a summary of the press release and a favors/disfavors analysis regarding a possible acquisition as the company searches for new financing sources.

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