［SENS Q&A］CGM was delayed FDA approval, would you remain confident in Senseonics(SENS)？
Key Takeaway:
● We are now informed that the FDA expects to assign our file to a reviewer and place it under review no later than April 15.
● A key business objective for us this year is to complete the IDE submission for this 365-day sensor, all subject to the availability of the FDA review group.
● We believe that we are now well positioned to address the top unmet need in the large and growing CGM market.
$Senseonics(SENS.US$ , a medical technology company, reported financial results for Q4 FY 2020 that the results fell short of Wall Street expectations.
Senseonics's revenue was $3.9 million, including $400,000 revenue from the U.S. and $3.5 million of revenue from outside the U.S. For the year, the company reported that its loss widened to $175.2 million, or 77 cents per share. Revenue was reported as $4.9 million.
Senseonics's revenue was $3.9 million, including $400,000 revenue from the U.S. and $3.5 million of revenue from outside the U.S. For the year, the company reported that its loss widened to $175.2 million, or 77 cents per share. Revenue was reported as $4.9 million.
Come and see what happened in the Q4 2020 earnings call!
This article is a script from the Q&A session of SENS's earnings call on March 4. In order to facilitate reading, we have made appropriate cuts. If you want to know more details, you can click here to re-watch the earnings call.
Q: What is Ascensia's go-to-market strategy that they've discussed with you as far as driving adoption? Are they going to target higher volume centers? Are they going to target centers that haven't really adopted CGM? Sort of how are they thinking about this? And what drives your confidence in the $12 million to $15 million?
A: The confidence comes because we have worked very significantly with Ascensia in this transition. So we together look very deeply at not only what the opportunity is for CGM. In our unfortunate downturn during COVID, we were able to retain a significant portion of the people that were on Eversense just because they become so dependent on it. So when you combine that research, that really is what drives the confidence that we have to be able to deliver these -- the guidance that we've given of $12 million to $15 million. We do think that given the installed base in Europe, we'll continue to be larger there for the first couple of years. We're anticipating still at about 2/3 of the revenue because the installed base is going to come from Europe this year.
A: The confidence comes because we have worked very significantly with Ascensia in this transition. So we together look very deeply at not only what the opportunity is for CGM. In our unfortunate downturn during COVID, we were able to retain a significant portion of the people that were on Eversense just because they become so dependent on it. So when you combine that research, that really is what drives the confidence that we have to be able to deliver these -- the guidance that we've given of $12 million to $15 million. We do think that given the installed base in Europe, we'll continue to be larger there for the first couple of years. We're anticipating still at about 2/3 of the revenue because the installed base is going to come from Europe this year.
Q: Could you give a little bit more color about exactly what that reorder rate is? Is there anything different about the U.S. launch? Obviously, it's a 90-day versus 180. But as far as the retention that we should be expecting here?
A: In Europe, where we really saw pretty consistent reimbursement rates. After about the first sensor, people typically reinsert about 75% of the time, after the second sensor, it's about 85%. By the time they're on the third sensor, they've fully chosen to use Eversense long term. So we're seeing reimbursement rates that are in the mid-90s. Now that is in the routine times. We did see some compromise to that during COVID, but it is our expectation that as we come out of the current COVID environment we're in, we're planning to be back at those rates in the coming year in '21 and beyond.
A: In Europe, where we really saw pretty consistent reimbursement rates. After about the first sensor, people typically reinsert about 75% of the time, after the second sensor, it's about 85%. By the time they're on the third sensor, they've fully chosen to use Eversense long term. So we're seeing reimbursement rates that are in the mid-90s. Now that is in the routine times. We did see some compromise to that during COVID, but it is our expectation that as we come out of the current COVID environment we're in, we're planning to be back at those rates in the coming year in '21 and beyond.
Q: You alluded to Medicare traction in the fourth quarter. Is there any way you can quantify in terms of percent of patients? Anything you can give us more in terms of the experience with Medicare in the fourth quarter?
A: It's still pretty early. Most of our focus has been in partnership on the training with Ascensia. It is a little bit different sale because the clinical practice does actually purchase the product as a medical benefit and then gets reimbursed from Medicare for it. So now it's a matter of making sure people get comfortable with how to do that ordering and get the reimbursement in place. So it's still quite a small number, but it is an important part of our future in '21. And a portion for sure of our U.S. sales plan.
A: It's still pretty early. Most of our focus has been in partnership on the training with Ascensia. It is a little bit different sale because the clinical practice does actually purchase the product as a medical benefit and then gets reimbursed from Medicare for it. So now it's a matter of making sure people get comfortable with how to do that ordering and get the reimbursement in place. So it's still quite a small number, but it is an important part of our future in '21. And a portion for sure of our U.S. sales plan.
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