Senseonics reports increase in revenue, looks towards US expansion

By Laura Lovett
02:44 pm

Not two months after getting the FDA nod for its implantable CGM, Eversense, Senseonics held its Q2 earnings call reporting a increase in year over year revenues. However, it continues to operate at a net loss.

“In a matter of just six short weeks, we’ve accomplished a lot. We’ve received the authorization from the agency to commercialize in the US, we launched our US commercial activities including the highly successful Mobile Clinic campaign, [and] we’ve already submitted one PMA supplement for label expansion,” Tim Goodnow, president and CEO of Senseonics said during the call. “Our operations team provided products to our strategic fulfillment partners, we shipped and completed our first commercial sale, we inserted our first patients at multiple clinics in the US during National Eversense Freedom Week and we have received our first positive coverage decision from a payer. All of this in less than 45 days."

In June, the company finally got the green light from the FDA for Eversense, its implantable continuous glucose monitoring system. It had been awaiting clearance since November 2016. The company is already selling its second-generation device — which can be worn for longer than the original — in Europe, the Middle East and Africa.

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While the US launch was big news for the company, during the Q&A portion of the call the company clarified that the actual product sales in the US were not part of the reported revenue as the FDA approval came through in June and shipping didn’t begin until July. 

However, the quarter did see an increase in year over year revenue. This Q2 the company reported $3.6 million in revenues up from $800,000 during last year’s Q2. Meanwhile, the company reported a net loss of $32.5 million or $0.23 per share during Q2, which is up from last year’s Q2 net loss of $12.4 million or $0.12 a share.

Preparing for the US launch, the company also reported adding $150 million of gross proceeds by completing an underwritten equity offering. 

Additionally, as the revenue increased, as did the total operating cost. This quarter the company reported a $20.1 million operating expense up $8.4 million from Q2 2017. The company attributed these costs to an increase in sales and marketing costs in preparation for the US launch and added R&D. 

Executives remain optimistic about the future, even deciding to bump up up full year guidances.

“[T]he product performance in Europe which obviously is the trajectory that we’ve been on. We continue to do extremely well with acceptance of the product. And the other portion of it is just the readiness that we have in the United States and frankly, the acceptance that we’ve gotten from the clinicians and patients to go into the procedures,” Tim Goodnow said on the call. “So, looking at the two of those, it now looks like we are going to be able to do a little bit better than we originally forecasted earlier in the year. So, in the sense of good transparency, we opted to go ahead and set that expectation.”

However, when asked about predictions for the 2019 year leadership was reluctant to give any concretes.

“But at this point it is just too early for us to make any comments on 2019,” Goodnow said. “We are literally in the market for less than six weeks right now. In regard to the performance in the United States, as you said, it is a combination too as I stated. What we are actively focused on, as Mike indicated, is getting the fishing licenses, getting the authorizations and approvals to go hunting with the insurance companies and their particular patients. We have one. There are many, many more to go that we are working on.”

The company has continued to see growth in the European market, where it originally started out. It reported an increase in its sale of Eversense XL, which lasts 180 days (the original version available in the US lasts 90 days). The company is reporting that the Eversense XL makes up 70 percent of its installed base. On the call Goodnow said that in the future the idea would be for that technology to be available in the US as well.