Did Senseonics Have a Bumpy Road in 2Q23?

While one  company in the continuous glucose monitor (CGM) market might have had a nearly flawless “earnings quarter,” the other big name in the space had a few bumps in the road.

Senseonics, the developer of the Eversense CGM, reported a loss of $20.4 million and missed on revenue expectations in 2Q24. The Germantown, MD-based company reported a 2Q23 loss per share of 4 cents compared to earnings per share of 22 cents a share a year ago.

During an earnings call, Senseonics’ CFO Rick Sullivan discussed guidance for 2023 revenue.

“We are reiterating our full year 2023 global net revenue to be in the range of $20 million to $24 million,” Sullivan said, according to a Seeking Alpha transcript of the call. “Our guidance reflects expected patient growth, which is expected to accelerate in the second half of the year and a decrease in Senseonics share of the Eversense revenue under the collaboration agreement in 2023, compared to 2022 based on both sales growth and being further along in the partnership.”

A bright spot for the company could be its upcoming 365-day CGM sensor. The company said the last patient in the ENHANCE 365-day pivotal trial will reach the one-year mark in September.

During an earnings call, an analyst asked Senseonics executives if there was a plan to release the data anytime soon.

“It's probably not best to press release the results from that given that it is an FDA submission,” said Tim Goodnow, Senseonics CEO, according to a Seeking Alpha transcript. “So, I think what I would expect is if we make the submission, which I do fully expect that we would do it based on comfort and performance of the data, it would be acceptable for approval. But it's generally not a good idea to press release the data before its peer reviewed and before the agencies had a chance to take a look at it.

FDA submission for the longer-duration sensor is planned for early 2024.  Potential approval could come in mid-2024, said BTIG analysts. The company also submitted an application for iCGM designation. Approval to integrate with insulin delivery systems is expected in early 2024, noted Ryan Zimmerman, an analyst with BTIG.

“While we like the Eversense technology, we cannot yet say with certainty that adoption trends are nearing an inflection point,” Zimmerman said. “We think a longer-duration sensor and iCGM designation will make the technology more appealing to a broader segment of the population, but until we see robust, sustained adoption of Eversense, we remain skeptical of the steep step-up in sales projected for 2024 and beyond.”

Remember that Other CGM Developer We Were Talking About?

Earlier this month, Dexcom blew analysts away with what could only be called a near-flawless earnings quarter.

“There were big expectations for Dexcom heading into this Q2 print and the company delivered, topping consensus sales estimates by $30 million and raising the full-year outlook well above the beat,” BTIG analyst Marie Thibault wrote in research notes. “This was a fairly flawless quarter and we think shares of Dexcom can move higher on Friday despite being priced for near-perfection.

One of the biggest drivers behind the San Diego, CA-based company’s success is the G7 CGM sensor. The device won a nod from FDA in late 2022. Dexcom had originally filed for an FDA nod in late 2021. However, a subtle software change and heavy FDA backlog after the pandemic led to delays in winning approval.