Senseonics Q1 2017 sees an expanding European market and plans for US launch, pending FDA approval

By Heather Mack
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Germantown, Maryland-based Senseonics may not be rolling in profits, but the company – which is working towards commercializing its implantable, long-term continuous glucose monitor – isn’t holding back on characterizing their position as strong.

With expanded commercial launches in Germany and Sweden, plans for a presence in eight European countries by mid-2017, a CE Mark for their second generation EverSense Smart Transmitter, plans for several clinical trials and initial regulatory plans underway for a US launch, Senseonics CEO Tim Goodnow said the first quarter of the year has the company off to a good start.

“We’ve made meaningful progress on two major initiatives,” Goodnow said on a call to investors. “We’re moving forward on clinical and regulatory milestones, building and expanding our commercial presence in Europe, and have begun preparing for our US commercial launch.”

That’s in the face of just $600,000 in revenue for the quarter, on top of increased marketing and operating expenses, and a net loss of $13.1 million compared to 2016’s first quarter losses of $11.2 million. Senseonics Chief Financial Officer Don Elsey said the company continues to project that their cash balance from Oxford and Silicon Valley Bank will take the company through the third quarter, but they are working “diligently to secure additional financing in the very near future, with a target of ensuring sufficient resources to support PMA approval for the US launch.”

But Goodnow said positive feedback from the potentially game-changing EverSense Smart Transmitter –  a pill-sized, implantable sensor that can last 90 days without needing replacement – has prompted the company to initiate full launches in Sweden and Germany and get the ball rolling for controlled launches in other European countries. To facilitate that, Goodnow said, Roche will continue to work as a distribution partner and increasing their footprint with four new representatives on their intensive diabetes team.

“The experience of these sales reps that routinely sell high technology diabetes devices increases our feet on the ground by many-fold, and strengthens the nationwide rollout of the product,” Goodnow said. “We are also in the process of initiating peer-to-peer educational activities, spearheaded by clinicians that have been involved with our initial controlled launch, to leverage their experiences. We expect these will be particularly valuable in ensuring smooth site ramp up, clinician comforts with the training and insertions, and in streamlining workflows.”

On the US front, Senseonics has submitted their premarket approval application to the Food and Drug Administration. As the company works with the agency to answer questions and resolve any issues needed for a substantive review, the FDA has been conducting inspections at Senseonics’ clinical and manufacturing sites.

“We would characterize our discussions at collaborative and productive,” Goodnow said of the FDA conversations. “Given the strong safety and efficacy data that we have generated in our submitted pivotal trial, we are happy to be providing greater visibility to the medical and patient communities. Our planning for the panel process has been underway, and has been including in our timeline assumptions, and the potential approval for fourth quarter is intact.”
 
In preparation for their US launch pending FDA approval, Senseonics also hired former Medtronic Vice President of Sales Mike Gill to lead their sales group for the Americas region.

Senseonics also has a pediatric trial underway in Canada, and initial feedback has given the company reason to believe the results will provide informative data that will be “instrumental in defining our US pediatric trial and a strategy for label expansion in Europe,” Goodnow said.

“On the product development front, we are continuing to make progress in R&D in our second generation sensor that will incorporate a completely redundant glucose sensing capabilities,” he said.  “We expect this to improve the accuracy, longevity and functionality of the system, with the ultimate goal of eliminating the need for a fingerstick calibration.”

Along with running the necessary clinical trials and regulatory requirements to get the technology into as many markets as possible, Senseonics is also carefully mapping out how to pursue reimbursement, and Goodnow said the company is in talks with private payers and clinicians. Since most of the devices in use in Europe were prescribed on a case-by-case basis and underwritten by Roche, Senseonics couldn’t point to Germany and Sweden as potential indicators for what to expect in the United States in terms of reimbursement.

“On the reimbursement front, we are getting of course the prescription which could have reimbursement, but the process of getting paid out by payers is not as thorough and as standardized for CGMs,” Mirasol Panlilio, Senseonics vice president of global sales and marketing said on the call. “Each payer has a different process, and we are finding there is a little bit more hand-holding than we would like, and that goes with entire category, actually. Once that goes, there are many more players in the marketplace and it will smooth things out, but right now, it’s just not as routine as we would like.”