DarioHealth announced a joint marketing agreement with Glytec to allow Dario’s connected BGM to integrate into Glytec’s Glucommander Outpatient insulin titration solution. Below, FENIX provides thoughts on why the partnership between Glytec and Dario makes sense for both companies.
Cellnovo announced that it does not have sufficient capital to support a broader launch of its Gen 3 tubed patch pump which is negatively impacting the company’s overall operations. According to the press release, Cellnovo “[intends] to continue contacts initiated with strategic partners and investors in order to protect the value of the assets.” Given the financial situation, Cellnovo initiated collective proceedings in the UK and conciliation proceedings in France. Below, FENIX provides thoughts on Cellnovo’s market position and the potential closure of its operations.
Yesterday, The Wall Street Journal reported that Livongo is preparing for an IPO in 2019. According to the story, Livongo has already approached Morgan Stanley, Goldman Sachs, and JP Morgan to underwrite the IPO with a company valuation >$1B. Recall, in March 2017, Livongo raised $52.2M in a growth round, and in April 2018, it raised an additional $105M with a total of $240M in private financing (previous FENIX insight). Below, FENIX provides additional thoughts on the Livongo IPO.
Tandem Diabetes Care announced that it is using the Tandem Device Updater to “resolve a Control-IQ technology software anomaly identified during the ongoing DCLP3 phase of the International Diabetes Closed Loop (IDCL) clinical trial.” According to the press release, Tandem is in discussion with the IDCL study investigators to evaluate any impact on the clinical or regulatory strategy. Recall, Tandem had been planning to launch Control-IQ as early as Summer 2019. Below, FENIX provides insight on the potential impact to the initial Control-IQ regulatory approval as well as thoughts on how Tandem has already started to spin the news as a positive indicator.
Glooko announced it is removing the subscription fee for its data management platform. Previously, users who did not have coverage through their insurance or employers were required to pay a fee to access the platform. Additionally, the Glooko/Senseonics data integration appears to be complete. Now, users can directly sync Eversense data to the Glooko platform via the Senseonics Cloud. Below, FENIX provides thoughts on Glooko’s new business model as well as insight into how the integration with Eversense likely benefits Senseonics more than Glooko.
Today, Lilly announced it will commercialize an authorized generic for Humalog U-100 at a 50% discount to the current Humalog per-unit list price for vial and Kwikpen. Nothing was mentioned about Humalog premixes. Below, FENIX provides summary and insight, including Lilly’s potential motivation and why Novo Nordisk is unlikely to follow.
Tandem Diabetes Care and Mylan both hosted their respective Q4 ’18 earnings calls. Of note, Mylan did not discuss its biosimilar insulin programs (including bs-glargine) or bs-glucagon. Below, FENIX provides highlights and insights from the Tandem earnings call.
Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.
Insulet hosted its Q4 ’18 earnings call and provided updates to its Omnipod business including the development of the Omnipod Horizon hybrid closed-loop. Of note, this is believed to be the first time that Insulet disclosed it received Breakthrough Device Designation for Omnipod Horizon. Below are highlights and insights from the call.
Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes market.