Senseonics Holdings, Inc. (OTCPK:SENH) Q2 2016 Earnings Conference Call August 9, 2016 4:30 PM ET
Don Elsey – Chief Financial Officer
Tim Goodnow – President and Chief Executive Officer
Danielle Antalffy – Leerink Partners
Kyle Rose – Canaccord
Jayson Bedford – Raymond James
Good afternoon and welcome to the Senseonics Holding’s Second Quarter 2016 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded.
I would now like to turn the conference over to Don Elsey, Chief Financial Officer of Senseonics. Please go ahead.
Thank you very much and welcome to the second quarter 2016 Senseonics earnings call. Before we begin today, let me remind you that the company’s remarks include forward-looking statements. These statements reflect management’s expectations about future events, operating plans, regulatory matters, product enhancements, and company performance and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties.
A list of the factors that could cause actual results to be materially different from those expressed or employed by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our annual report on Form 10-K and our other reports filed with the SEC. These documents are available in the Investor Relations section of our website at www.senseonics.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law.
With that I will now turn the call over to Tim Goodnow. Tim?
Thank you, Don. Good afternoon and thank you for joining us on our quarterly call. The second quarter has been a busy and productive quarter for the company. We signed a distribution agreement with Roche, presented our 180 day trial data at the ADA, launched The Eversense System in Sweden, expanded our debt facility and increased our cash runway, we have filed a CE Mark for our labeling up to 180 days and we completed the U.S. clinical trial with excellent results.
On today’s call, I will start out by discussing the top-line results of our U.S. pivotal trial that were announced earlier today, which show that our system provides state of the market accuracy for a CGM System. Then I will recap the European full 180 day trial data as well as provide an update on our launch in Sweden. I will conclude by addressing anticipated market launches and providing a summary of key regulatory development initiatives. Don will provide detail on our financial results and then I will wrap up with a review of our upcoming expected milestones.
This afternoon we were very excited to release top-line results from our U.S. pivotal trial. The primary effectiveness objective of this study showed a compelling accuracy of 8.8% MARD over the 90 day sense of life. As you may recall, we began the U.S. PRECISE II trial in early January in 8 clinical sites across the country.
The purpose of this study was to evaluate the safety and effectiveness of the Eversense system over 90 day period in adults with diabetes. It was an open-label non-randomized single arm multicenter pivotal study with very positive patient support and product acceptance. We were able to enroll the full 90 patient population by the end of March and the last enrolled patient completes all testing and safety follow up by mid July.
As previously described study participants visited the clinical centers at one, 30, 60 and 90 days post-inception for in-clinic accuracy characterization. The centers included in the study are well versed in participating FDA accuracy studies with most having direct experience in chronic approval trials from Medtronic, DexCom and Abbott CGM Systems. Between the clinical data, the participants wore the device at home and followed labeling instructions that included two finger stick calibrations per day using a standard home blood glucose meter.
The PRECISE II trial design was very similar to the protocol used in European PRECISE pivotal trial; the device has prospectively calculated glucose levels. However, the devices were blinded to not show real-time glucose results nor provide any glucose related alarms to the participants. Importantly, we were able to use clinical results in data previously obtained from the European PRECISE study to obtain and improve the calibration and glucose results algorithm and we implemented this improved algorithm in the product configuration used in the U.S. PRECISE II study.
Compared to all prior primary CGM PMA application studies, PRECISE II was the largest ever in number of study participants and data collected in at length of trial. Over 16,000 comparative data points with over 2 million glucose readings were collected on 90 participants over the full 90-day investigation. Our full clinical data analysis from this study and the generation of the clinical evaluation report is underway, so we will look forward to be one of the key elements of our PMA submission later this year. At this point, we have completed the CGM accuracy portion of the assessment. And as I highlighted, we reported a mean absolute relative difference, or MARD, of 8.8% against the standard YSI Lab reference analyzer.
The 8.8% MARD was achieved over the 90 day continuous wearingacross the systems overall glucose range of 40 to 400 milligrams per deciliter. The system’s safety performance was also very positive, which along with additional results will be published shortly. Needless to say, we are excited that our first generation glucose monitoring system in improved algorithm has demonstrated strong performance that is equal to or superior to that other CGM system in the market.
Let me now turn to the recent FDA panel meeting. As many are familiar, the clinical chemistry and clinical toxicology devices office or IVD have the panel meeting with clinical experts on July 21st to solicit feedback regarding the benefits of expanding to a non-adjunctive label for the DexCom, Gen5 CGM System. In a very positive move for people with diabetes, the panel supported the labeling change on a voted 8 to 2.
As we have seen in our interactions, the FDA demonstrated a positive bias towards accepting new technology and advancing the utility of the very accurate CGM devices for people with diabetes. Although the full approval of the labeling change is not yet granted from the agency, it is our expectation that the dosing claim will be allowed to these very accurate CGM systems with adequate training, labeling, product attributes and robust post market surveillance to support the safe use of the devices.
With a completion of our pivotal trial, it is our objective to show in our PMA submission that with a highly accurate clinical data obtained in our pivotal trial, our Eversense CGM System is safe and effective. We will naturally be working with the FDA during submission process to provide all the information required to work towards the PMA approval. We also point that we’re collaborative with the agency during the review process to determine the right approach to pursue a dosing claim for the Eversense CGM System as quickly as possible.
And turning onto clinical front, we presented a full 180 day PRECISE study data at the recent American Diabetes Association Conference in New Orleans. As you recall, the European PRECISE study data was the basis of our 90-day CE Mark product. The 180 day study show that the MARD observed in the 90-day results was maintained for the entire 180-day period. A key finding in this study was that the medium sensor light was 149 days. The study results confirmed long-term accuracy of this sensor and demonstrated sensors retained their high accuracy performance throughout their entire life.
On the basis of this data, we submitted a CE Mark amendment to extend the labeling claim for those sensors lasting longer than 90 days. We anticipate that by the time we received approval of the amendment, the majority of the sensors were performed through 180 days. It is also our expectation that within the next 12 to 15 months with additional sensor improvements under development, we will demonstrate a full 180 day sensor life for all sensors.
Switching now to the commercial side. We completed our first commercial sale on patient insertion in Sweden in June. We trained a number of physicians on the insertion procedure, all of our positive experiences and they successfully completed the procedure in less than five minutes. All patients are up and running in using their systems at home. We continue to work closely with Rubin Medical on patient and healthcare provider training as well the marketing programs to execute our controlled launch in Sweden.
Through this collaborative process, we have gained valuable insight into the clinic workflow and new patient startup procedures. With that we have modified our training with a focus on user startup and smartphone connection to ensure the most positive experience possible for our users. In May, we announced a partnership with Roche for exclusive distribution of the Eversense System in Germany, Italy, and the Netherlands. The local commercial teams are now in the midst of completing or initiating the end market controlled rollout.
Signal to our controlled launch in Sweden with Rubin Medical, we are working closely with Roche to prepare the market and setting appropriate commercial infrastructure to support our initial clinic and users. We have planned to initiate a controlled launch in Germany in September followed by Italy and the Netherlands in early Q4. In June, it was announced that in Germany continuous glucose monitoring is now reimbursement of a drug program that applies to both Type 1 and Type 2 insulin using patients and include CGM systems providing alarms to the patients.
This of course is great news for many patients and clinicians in Germany, who have been eagerly awaiting reimbursement. The Eversense CGM System was real-time continues glucose readings and both predicted and threshold glucose alarms meets the federal agencies definition of CGM Systems that are included. Consequently, we are covered under the newly approved CGM reimbursement category.
We have now completing the application in partnership with Roche for product specific reimbursement restriction codes as statutory health insurance company were required to get the product reimbursed. This is part of a standard practice to products began reimbursement in Germany and we anticipate that the code will be available in Q4. We also expect the pricing under the reimbursement program will be negotiated with each payer. We are working hand in hand with Roche to establish the appropriate pricing for the Eversense System.
In summary, we are very pleased with our commercial progress beginning with our launch in Sweden. We are incorporating feedbacks during this controlled launch phase to the Eversense System to strengthen our broader European rollout in Germany, Italy, the Netherlands, Norway, Denmark and the rest of Europe.
Now, I would like to turn the call back over to Don to review our second quarter and first half financial and our expectations for the balance of 2016.
Thank you, Tim. For the three months ended June 30, 2016, total net loss was $11.9 million, or $0.13 per share, compared to $7.2 million, or $3.68 per share in the second quarter of 2015. Second quarter 2016 net loss per share is based on $92.7 million weighted average shares outstanding, compared to the $1.9 million weighted average shares outstanding in the second quarter of 2015. We currently have just over 93 million shares outstanding and expect that number to remain relatively stable for the balance of 2016.
For the six months ended June 30, 2016, total net loss was $23 million, or $0.27 per share, compared to $12.9 million, or $6.63 per share in the first half of 2015. First half 2016 net loss per share is based on the $85 million weighted average shares outstanding, compared to $1.9 million weighted average shares outstanding in the first half of 2015. The largest driver of the increase in net loss was higher operating expenses compared to last year. Specifically our total operating expenses for the first half increased $10.2 million to $22.5 million driven primarily by $5.1 million increase in R&D spending and a $4.3 million increase in G&A spending.
When compared on a sequential quarterly basis, total operating expenses increased by $600,000, or 5%, increases primarily in clinical trial expenses and other R&D expenses of $1.1 million offset by a decrease of $500,000 in non-cash compensation accounted for the majority of the growth.
I'd like to now turn to our balance sheet at quarter-end. As we recently announced, we have established a new debt facility arrangement with Oxford Finance and Silicon Valley Bank. This facility provides for loans up to a total $30 million. This credit facility has an initial funding of $15 million followed by three trenches of $5 million each, which the company may draw on based on achievement of specific milestones.
With this new debt facility, the previous facility was repaid and closed. At the end of the second quarter, our cash and cash equivalents were $36.2 million. This included the net proceeds from our recently expanded debt facility. Our current outstanding debt balance is $15 million. As we stated last quarter, we remain focused on ensuring that we perform with a highest level of excellence, while at the same time managing their spending closely with a goal of ensuring our cash runway is as long as possible.
With that in mind, let me turn to our guidance. We continued to project that 2016 revenues will be less than $1 million. With respect to spending for this year, we estimate total OpEx for 2016 to be between $37 million and $41 million of which $3 million to $5 million will be non-cash items. This is consistent with the guidance we gave in the first quarter. Lastly, we continue to project that our current cash plus our debt facility will be sufficient for operating needs since third quarter of 2017.
I will now turn the call back over to Tim.
Thank you. Now that we've given you a summary of the last quarter, I want to give an update with respect to our product developments and upcoming milestones. First on the back of the U.S. trial, we just completed, we are working hard to complete our PMA submission material. This is a primary focus for the entire organization and we continue to expect to submit the PMA in the next few months.
Secondly, we continue to make progress on the development of our next generation smart transmitter. This new transmitter has all the current features is removable and rechargeable provides on body vibration alerts and it’s a one-year live. On top of that, it will be 55% smaller and more ergonomically attractive. We plan to file CE Mark amendment application for this next generation component later this quarter.
Additionally, we are also committed to expanding the indication to the pediatric population. I'm excited to announce your approval of the Health Canada, Pilot pediatric study at a leading diabetes center in Toronto. There we will be enrolling 30 pediatric subjects for a 180-day study. The trial design will be very similar to the PRECISE and PRECISE II trials where the subject will continue come to the clinic at regular intervals for accuracy measurements, while using the device at home at all times. We plan to use the safety and accuracy data generated in this study to support an IDE application for a pediatric trial in the United States.
In summary, we are of course pleased with the strong accuracy, patient acceptance as well as clinician acceptance that we observed in the U.S. PMA clinical study. Our first generation product continues to show very strong analytical performance extremely long sense of life and compelling user acceptance. We look forward to bringing a highly differentiated CGM product to people with diabetes.
Lastly, we continue working on a number of funds to improve the Eversense Systems by enhancing accuracy even more and further expanding its longevity. We have multiple internal projects that we believe will accomplish both of these goals in the next 12 to 18 months. Our objective is to provide an Eversense System that maintained a single digit MARD has calibrated only once per day and has a full 180 day life.
As we reflect on our accomplishments in the first half of this year, we look forward with excitement to the additional milestones on top of the balance of 2016. As noted, near-term focus includes our PMA submission, the full publication of the PRECISE II data at the Diabetes Technology Society Meeting in November, our first pediatric experience in October, launch in Germany, Italy and the Netherlands, further expansion of our distribution partnerships and market launch of our next generation transmitter, 2016 continues to be a very transformative year for Senseonics.
This concludes our prepared remarks. Joining us for questions are Mukul Jain, our Head of Operations including Regulatory Finances; Mirasol Panlilio, our Global Head of Commercial Activity; and Lynne Kelley, our Chief Medical Officer. Operator, let’s open the call for questions.
Certainly, we will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Danielle Antalffy from Leerink Partners. Please go ahead.
Thank you so much. Good afternoon guys and congrats. That is such an impressive MARD. And Tim given where it is, it's well below where it was in the CE Mark trial. It's the lowest now on the or soon to be on the market. So just wondering if you could provide some context or commentary around how this might change your view and speed of adoption of the product if at all because certainly we were kind of thinking about it more along that if it was a 10% MARD that would be great, but this is pretty phenomenal. So just wondering if you could give any color or perspective on the potential ramp now with an MARD like this?
Well, we're certainly excited to get the level of performance. We have some very strong indications as we're going in. We wanted to be a little bit conservative with what we projected, but we have been very excited based on what we learned in the European trial. So it really as a testament to the quality of the technology and frankly the number of great people that are in the organization that makes this happen.
As you point out the accuracy has been one of the key differentiator and as we’ve seen the technology and the market really advanced for CGM and is directly correlatable to the accuracy and now that there are a couple of different alternatives that are below the 10% range. I expect that that's going to continue to grow and accelerate quite rapidly, frankly. I think we're well beyond the tipping point of recognition for the use of CGM with the active insulin uses is of course very high and we hear a lot of conversations about our moving into the Type 2.
So it is the center of the bull’s-eye. It is the most important element. And we recognized that we're going to need to stay there as we go to the one calibration a day, one calibration a week and even out to no calibration. There's no going back at this point.
And any early feedback or I guess it's tough to say because you guys just started the launch in Europe, I think you said June you guys in plan at the first or got the first patients on the system, but anecdotally any feedback on how the physician procedure went, it sounds like you said it was done under five minutes. And just early experience in the real world on the device, are you seeing this level of accuracy in the real world as well? Thanks so much.
Yes. Now, we've been very happy with initial response. I’ll let Mirasol speak to the clinicians. We worked very closely with them on the training. And obviously, we've been staying in touch with the early patients. So, I’ll let Mirasol to fill in some more detail on.
I’m happy to report that everything went well with our first clinic and patient use. I think we were very excited, I don't know who’s more excited: us, the distributor, the clinic staff or the patient themselves, but, as Tim reported, all the patients are up and running. In fact the doctors and the nurses that we trained to the person they thought it was very easy. It was probably the easiest part of the whole training for the first insertion, things went just very smoothly. And so, we're continuing to evaluate other ways that we can improve not just additional training for the physicians and nurses, but also for the patients, but things went very well for the first launch experience.
Okay, thanks so much.
Our next question comes from Kyle Rose of Canaccord. Please go ahead.
Great, thank you very much for taking the question. And I [indiscernible] Danielle there with regards to the strong accuracy in the trial. I just wanted to see – I think that came well ahead of our expectations and I think you know candidly in some of the conversations, we've had in the past, probably ahead of your expectations as well as. Just anything that you learned from this trial as far as what you take away from the technology? I mean, I think, we were looking for upper single-digits? Do you think about maybe the second gen even some of the later generation technologies there? Just wanted to see how you think about this and how it may change your plans both in the U.S. and O.U.S. with this data?
Well, certainly, we are very happy as I said to a give this level of data. I would say that we were a little bit more optimistic than maybe we had foreshadowed. I think I had said that we’d be less than 10.5 in way I’ve communicated previously, but I certainly had higher expectations than that. Obviously, the key thing from our perspective is the biggest news and most recent movement in the space has to do with the dosing claim and I know that many of the folks on the phone participated in it or at least watch the entire process.
So, we are at a significant point of change for not only acceptance and utilization, but the recognition by the regulators of the value of CGM. So now that we have very high confidence that we have a very accurate CGM, it is our expectation that we will be working very aggressively with the FDA to understand what is the best way for us to put a product out as quickly as we can for people in the United States to be able to use the product. So I would say that’s probably the biggest recognition with a significant single-digit MARD product.
And then one another data point is it – do you have the amount of sensors that lasted out to the 90 days as far as those 90 patients? I mean how many of them got to the full 90 days and just what the sensor durability was? And then what expectations are for getting – and starting a longer-term trial in the U.S. as well?
So, we do have that data, but we're not going to release that as of yet, Kyle, [indiscernible] at the Diabetes Technology Conference. Overall, I would say that on many elements of the clinical trial, we were very, very pleased with the outcome. So, we'll ask you to stay tune for that specific information. As I alluded to in my comments, our confidence is very high on our ability to pretty quickly deliver the one 180 day version of the product. And as you know, about half of the sensors from the earlier version lasted to a 180 days. We expect that's going to continue increase. And as I said in my comments, in 12, 15 so months, I would expect it will have all sensors at 180 days. And we’ll of course be expanding our labeling with additional clinical studies to support that.
I appreciate that. And then last question I'll hop back in queue is you know when you think about the German reimbursement approval and the current commercialization O.U.S., I understand you haven’t given longer-term guidance after 2016, but I think consensus stands to somewhere in the $8 million to $10 million range. Does the reimbursement approval change your expectations as far as broader commercialization in 2017? And do you think that you feel confident with respect to how the street is modeling your 2017 numbers?
Yes, I think we’re comfortable with where we are right now. I don't think I would be as bold as early in the process to say that we should take a little bit bigger – a little bit bigger bite at. We certainly will do our best to deliver this product to as many people as we can. But at this point, it's just too early, obviously pricing needs to be negotiated. There were a lot of dynamics that go on around that. So let's continue to do our best. We work with our partner Roche, which is an excellent organization and obviously an extremely excellent organization in Germany to help us work our way through it. So, at this point, let’s stay tuned and continue to work hard.
Great, thank you very much for taking the questions.
Our next question comes from Jayson Bedford of Raymond James. Please go ahead.
Good afternoon and congrats on the results, certainly a nice number. I guess with respect to the dosing claim, Tim you were at the meeting with the data you've gathered from the PRECISE II trial here. Do you think you can replicate most of the analysis that was presented by the sponsor of the panel or do you think you'll need to generate additional data?
No, I think, you're going to actually generate additional modeling data, right. I think even though that wasn't well accepted by the panel members, the FDA does very much want to see what happens under your particular performance distribution, what is the risk that you may incur with an accuracy that’s higher than strips and meters. If you believe this strips and meters are in that 5% to 7% MARD range, maybe some are a little bit higher of the poorer quality strips and meters, we are very much approaching it. But I do think we’re going to have to demonstrate, would be my guess with the modeling work that needs to be done. So, I think, we have not yet talked to the FDA. Obviously, we haven't submitted this data to them. We are, of course, planning on it, doing it very quickly. We'll have those conversations, but my guess is we’ll need to provide that modeling data.
But the PRECISE II trial has enough data that you can do that analysis. It's not like you’d have to generate additional human data for the label.
I believe that to be true. As I said, this is the largest primary CGM study that has been done to date. So from that perspective, we certainly do.
Okay. On the CE Mark amendment for the 180 day label are up to 180 days. What's the timing on when you think you can get that label?
We're not going to forecast that right now, Jason. We are in active conversation with the notified body. To be very frank, we've got a little bit in front of ourselves in regards to the original CE Mark. So I think we want to learn from that. We’re working very hard on it and we'll continue to do the best we can to stay in good conversation with them, but we're not going to yet give a date.
Okay. And just maybe on the commercial side, and I apologize if I missed this, have you started selling in Norway and Denmark, or is it still just Sweden right now?
Right now, it is just Sweden. We are launching, well. I’ll let Mirasol to fill-in what the short-term plan is?
I think for Norway and Denmark, we've got them scheduled for Q4. And then I think the next up for us would be in September with Germany.
Helpful. And then has the post market study been a deterrent to adoption at all?
No not at all. As I said – as we said on the call, it was fully expected with having an implantable device that we would have to do a post market surveillance program. We do anticipate that we will have to do that in the U.S., but it has been no deterrent at all to the commercial activities.
All right, thank you. I will let someone else to jump in queue.
This concludes our question-and-answer session. I would like to turn the conference back over to Tim Goodnow for any closing remarks.
Well, we are very, very encouraged with the results that we’ve been able to obtain not only in the last quarter, but also in the first half of this year. We want to continue to thank the participants. This was a fairly lengthy much longer than any other clinical trials that have been done. And the requirement that it would be blinded to the user really requires that they have an extra level of interest in doing the study, if they’re going to basically wear a black box for 90 days. But they were able to do and we thank them very much for their participation. It’d certainly the testament to their interest in finding new solutions for people with diabetes. And we want to continue to work very hard to make sure that we can be one of those solutions. So with that, we’ll end the call and thank you all for your participation.
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
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