Senseonics - Q2 2023

Transcript

Operator (participant)

Good day, and welcome to the Senseonics Second Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero on your touch-tone phone. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one. To withdraw your question, please press star, then two. Please note this event is being recorded. I'd now like to turn the conference over to Trip Taylor, Investor Relations. Please go ahead.

Trip Taylor (Primary Investor Relations Contact)

Thank you. This is Trip Taylor from The Gilmartin Group. 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, company performance, and other matters, 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 implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our annual report on Form 10-K for the year ended December 31, 2022, our Form 10-Q for the quarter ended June 30, 2023, and 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. Joining me from Senseonics are Tim Goodnow, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. With that, I would like to turn the call over to Tim Goodnow, President and CEO. Tim?

Tim Goodnow (President and CEO)

Thank you, Trip. Thank you all for joining us this afternoon. Today's call will start with an overview of our quarterly financial results, followed by an update on Senseonics' continued execution of development, clinical and commercial programs to drive growth. Our Chief Financial Officer, Rick Sullivan, will provide details on our financials. We'll open up the call for questions. In the second quarter, Senseonics generated total revenue of $4.1 million, representing 11% growth compared to the prior year period, including $1.8 million of revenue from the U.S. and $2.3 million from outside the U.S. Eversense shipments continue to be in line with our expectations for 2023. The second quarter continued to be productive for Senseonics as we advance our initiatives designed to improve ease of use and increase patient adoption of Eversense while enhancing our technology pipeline.

To begin, I'll describe recent progress that we've made in our collaboration with Ascensia Diabetes Care, our global commercial partner, on their initiatives to drive adoption of Eversense by providers and patients. Together, we are focused on two main objectives: increasing awareness in the market and increasing access to Eversense by our users. During the second quarter, we made meaningful progress in both areas, including the expansion and training of new sales professionals in ADC's dedicated U.S. CGM sales force. We also earned a positive policy decision from UnitedHealthcare to cover Eversense as of July 1st and we increased regional coverage by the Nurse Practitioner Group, certified and credentialed practitioners who conduct Eversense insertions. Broadening the commercial footprint is a critical component of increased awareness and access in an area in which Ascensia continues to invest.

An expanded sales force is enabling increased physician interactions and new account engagement, which ADC will leverage to increase their presence in numerous territories. The sales force is planned to increase to 50 professionals, while currently at about 45 reps who are onboarded and trained. Ascensia expects a few quarters for individuals to ramp to full productivity after onboarding. In addition to growing the dedicated sales force, ADC is investing to enhance the Eversense brand. They are focused on developing new consumer-facing materials to expand and increase the awareness and benefits of Eversense. We believe a strong, cohesive brand message outlining our product's unique characteristics will help position Eversense as a leading CGM solution in patients' and clinicians' minds. We look forward to ADC rolling out updated messaging and creative in the coming quarters to advance the brand's positioning.

It's known that every diabetes patient can benefit from Eversense and should be able to access Senseonics technology. The partnership has established several programs that support this vision. While our initial focus was to train endocrinology professionals to do the insertion procedure, who have large populations of diabetes patients within their practice, the second phase of our strategy, we call prescriber first, is underway. It expands on Eversense Endocrinology Inserter network by providing convenient insertion options to patients managed by a broader set of healthcare professionals such as family medicine, primary care, and internal medicine, those treating the increasingly type 2 patients who use Eversense. As part of this, the Certified Eversense Specialist program identifies and trains healthcare professionals on the procedure who are interested in accepting new patients for insertion.

Additionally, in a parallel vein, the Nurse Practitioner Group is an instrumental partnership that was established at the end of last year and continues to account for a growing portion of Eversense insertions. In the second quarter, over 12% of the total insertions were completed by NPG. This is more than double the prior quarter. NPG currently has Eversense insertions in over 30 cities, and they are on track to expand further by the end of 2023. Leveraging the extensive team at NPG, along with the Certified Eversense Specialist Network, not only makes it easier for patients to get Eversense, but it also streamlines the process for physicians who want their patients to get the benefits of Eversense, but prefer to prescribe and leave the insertion to another provider.

In parallel, ADC is expanding their clinic targeting to prescriber-only physicians to inform them of these new options so that they can easily manage their patients with Eversense. This strategy allows sales reps to focus more on selling the unique benefits of Eversense and less on the associated workflow and insertion process, thus enabling the field sales and clinical personnel to expand their reach and connect with more healthcare providers. Additionally, in supporting further expansion, as physicians learn of the benefits of Eversense, combined with the established reimbursement for performing the procedure to receive requests, insertion, training for physicians who want to prescribe Eversense and insert Eversense for their patients, we continue to support, excuse me, and certify them.

Ultimately, we know it's important patients have easy, convenient insertion options, and we're making great strides for expansion across each of the three strategic networks: NPG, Certified Eversense Specialist Network, and the traditional prescriber inserter physicians. Building on these initiatives, ADC continues to take active measures to increase access through their patient assistance program. The current program, which offers a $99 copay on each of the first two sensors, gives patients the opportunity to wear and become familiar with the convenience and benefits of Eversense for a full year without worrying about large copays or deductibles. This program is assured that we can support more patients in experiencing our product's benefits over a longer term and prepares our markets for the 365-day product that we expect in 2024. Rounding out our progress on access, we recently had a positive coverage decision for implantable CGM from UnitedHealthcare.

As of July first, UnitedHealthcare began providing coverage for Eversense for people with type 1 and insulin-requiring type 2 diabetes. United was the last top 10 payer not covering Eversense, and now adds an additional 45 million lives to our coverage population. With this addition, we are nearing almost all insured adults in the United States having access to the Eversense system, thereby expanding coverage to benefiting approximately 300 million covered lives. United's policy updates adds to the extensive number of payers who include Eversense in their CGM coverage policies, as well as paying for the healthcare provider's time for the in-office insertion procedures. Importantly, this allows ADC to introduce the Eversense CGM system to more people living with diabetes. Shifting now to a brief update on our partners' efforts in Europe.

Similar to what we discussed last quarter, ADC is continuing to work through the changing market dynamics in Germany and is focused on executing in new distribution channels. These are addressing reimbursement and taking action to ensure patients have access to Eversense. We continue to see attractive growth in our second-largest European market, Italy, where we are continuing to win new tenders. Further supporting our Eversense awareness initiatives, we published key clinical data in the second quarter of this year's ADA meeting. This includes two studies that demonstrate the safety, accuracy, and longevity performance of Eversense. The first study showed that a modified Eversense system provided accurate performance through the full 365-day period, with a favorable MARD, longevity, and safety profile. Importantly, this is the exact configuration that's currently under evaluation in a 365-day pivotal trial.

We believe that performance in this study bodes well for our ongoing 365-day trial, which is planned to conclude in the coming weeks. Additionally, the second study importantly showed that statistically significant superior health improvements were achieved with the use of Eversense in CGM naive patients, compared to their traditional self-monitoring of blood glucose routines. These studies demonstrate the value of our product pipeline, which can provide for patients and providers an expanded and advanced technology with future generation products. These coming products are centered around advancing our Eversense system forward through adding further significant differentiating features. We are confident that these new products can keep Senseonics at the forefront of diabetes technology innovation and be incredibly appealing to the patients and providers. In the nearest term, we are focused on extending the wear time duration of Eversense to one year.

The 365-day ENHANCE trial is designed to evaluate the accuracy and safety of Eversense for our next generation sensor. This pivotal trial is nearing its completion, as the last patient evaluation visits will be finished in September. Our goal is to continue expanding our ability to transform the lives of those in the global diabetes community. The positive results from the 1-year trial will be a meaningful step forward. An important milestone and update, we are pleased to announce that we have recently submitted to the Food and Drug Administration for the iCGM designation for Eversense. Our expectation is an approval in early 2024. That would enable our ability to integrate with insulin delivery devices like pens and pumps, to create systems that would use Eversense for autonomous control.

Senseonics has a number of development programs currently in place utilizing the planned iCGM designation. We look forward to providing details of these partnerships in the near future. In addition to the ENHANCE trial for our 365-day sensor, our product pipeline focuses on adding independent power and direct communication capabilities to our sensors. These advances would allow for the intermittent glucose monitoring based on swipe queries and ultimately remove the need for any on-body transmitter. We continue to make positive strides with both the Gemini and Freedom systems. We believe these products have the potential to offer patients increased flexibility, ease of use, and simplicity, with the goal of achieving patients' most desired features: high accuracy, independence with extremely long wear time, and the freedom of not needing to wear any device on the skin.

I'll now turn the call over to our CFO, Rick Sullivan, to go over the details of our second quarter financial results.

Rick Sullivan (CFO)

Thank you, Tim, and good afternoon, everyone. We appreciate the opportunity today to update you on our business. In the second quarter of 2023, net revenue was $4.1 million, compared to $3.7 million in the prior year period. U.S. revenue for the third quarter was $1.8 million, and revenue outside the U.S. was $2.3 million. As a reminder, net revenue to Senseonics in 2023 will represent approximately 70%-75% of the total Eversense revenue generated in the global markets, as the revenue share for our partner increases according to our collaboration agreement with Ascensia. Senseonics recognizes revenue based on our revenue share when shipments are delivered to Ascensia, initiating the multi-step distribution to patients via Ascensia and their distributors.

Gross profit in Q2 2023 was $0.4 million, a decrease of $0.4 million from a gross profit of $0.8 million in the prior year period. The reduction in gross margin was primarily driven by an increase in the revenue share precentage due to Ascensia, and gross margins were in line with expectations for the full year. Research and development expenses in Q2 2023 were $12.8 million, an increase of $3.5 million compared to $9.3 million in the prior year period. The increase was primarily due to investments in our product pipeline for development and clinical trials of next-generation technologies. Second quarter 2023 selling, general and administrative expenses were $7.5 million, a decrease of $1.1 million compared to $8.6 million in the prior year period.

The decrease was the result of reduced personnel costs and other general and administrative costs. For the three months ended June 30th, 2023, operating loss was $19.9 million, compared to $17 million in Q2 2022, due to the increased investments in R&D. For the three months ended June 30th, 2023, total net loss was $20.4 million, or $0.04 loss per share, compared to net income of $104.2 million, or $0.22 gain per share in Q2 2022. Net income decreased by $124.6 million due to the accounting for embedded derivatives, fair value adjustments, and the exchange of the PHC Notes last quarter.

As of June 30th, 2023, cash, cash equivalents, and short and long-term investments totaled $125.1 million, and debt and accrued interest was $52.4 million. In continued efforts to strengthen our balance sheet, earlier today, we entered into a series of exchange agreements with a set of holders of our 2025 Notes to exchange $30.8 million in principal amounts of the notes for a combination of cash and stock. The notes to be exchanged are convertible into approximately 23 million shares. In the exchange, we will deliver $7.5 million in cash, which we raised on the ATM during the second quarter, and an additional number of shares of common stock to be determined based on our average trading price over the next few weeks. We expect the arrangement to result in incremental low double single-digit dilution.

The agreements contain a provision to protect against unforeseen market events, which places an absolute limit on the total number of shares being issued. If executed as planned, the exchange will reduce our outstanding indebtedness to approximately $20.4 million, extinguish the covenants in the 2025 Notes, providing us with additional financial flexibility, and save approximately $2.3 million in interest expense for the remaining life of the 2025 Notes. As a housekeeping matter, we also filed an S-3 registration statement to facilitate shifting our ATM to Goldman Sachs, who advised us on the debt exchange. This registration statement registers only the dollar amount of stock remaining on our prior ATM.

We will continue to monitor our capital structure and market conditions going forward, and we may opportunistically evaluate the potential to access the debt and equity or equity-linked markets over time. At present market conditions and pricing levels, our current expectation is to seek to fund the majority of any nearer-term business operating needs through incurring non-convertible debt. Turning to our outlook for 2023, we are reiterating our full year 2023 global net revenue to be in the range of $20 million-$24 million. 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.

For gross margins, we continue to expect full year gross margins to be between 7.5% and 12.5%. The year-over-year decrease in our gross profit margins are the result of the decrease in our share of Eversense revenue. For full year 2023, operating expenses are expected to increase compared to 2022, based on investments in R&D, targeted to complete the adult 365-day trial, the beginning stages of the pediatric trial, and investments in our future products, Gemini and Freedom. With that, I will turn it back to Tim.

Tim Goodnow (President and CEO)

Thank you, Rick. We are pleased with the progress made in the second quarter and expect the continued execution of our initiatives to further advance the company and drive greater patient utilization. We continue to leverage superior clinical data, a strong product pipeline, and active commercialization efforts driven by Ascensia to expand our footprint within the diabetes market. We believe we are well positioned to grow our franchise to create shareholder value and look forward to updating you on our progress in the future. Thank you for your time today. Also joining us for questions is Mukul Jain, our Chief Operating Officer. Operator, let's open up the call for questions.

Operator (participant)

Thank you. We will now begin the question-and-answer session. To ask a question, you may press star, then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Matthew Blackman with Stifel. Please go ahead.

Colin Clark (Healthcare Equity Research Associate)

Hi, this is Colin on for Matt. I wanted to start on the U.S. number for the quarter, which was down sequentially. Just curious, was there any outsized Ascensia destocking, domestically, like, relative to what you were expecting? Or were there other, other dynamics that didn't play out as you anticipated? Any metrics that you could share that tell a different story, like training or any other leading indicators you follow, that would be helpful, too. Thank you.

Tim Goodnow (President and CEO)

No, really, the quarterly, as we described, earlier in the year, with the inventory dynamics, we did anticipate that, that Ascensia would be optimizing their, their stocking levels in the first couple of quarters. That certainly has occurred, and this is all part of that, that transition. The plan, as we've guided to, is a significant ramp in the, in the second half of the year, and we feel well placed to be in, in that transition.

Colin Clark (Healthcare Equity Research Associate)

What gives you confidence in the, in the full year guidance reiteration? Has anything changed with regard to the geographic mix of the business that you expect? Is it really that you're expecting that U.S. ramp to happen, predominantly domestically, rather than the OUS sales mix you saw this quarter?

Tim Goodnow (President and CEO)

Yeah, it is. It is predominantly the U.S. growth. You know, key drivers are, of course, the additional sales reps that Ascensia has put in place that began in the second quarter of this year. Additionally, of course, we did have the win with United, which is just beginning here in this third quarter. The plan growth and effectiveness of those sales reps, as well as the consumer advertising, which we do anticipate will continue to ramp here in the second half of the year.

Colin Clark (Healthcare Equity Research Associate)

Great. Thank you very much.

Operator (participant)

Our next question comes from Marie Thibault with BTIG. Please go ahead.

Sam Eiber (Medical Technology Analyst)

Hey, guys, you've got Sam on for Marie. Thanks for taking the questions this afternoon. Maybe I can start on the submission for the iCGM designation. Congrats on, on getting that through through the door. Any way to quantify how large of an impact that could be to new patient starts, you know, once you get the potential approval? Is it fair to say you'll be working with the two large open pump players?

Tim Goodnow (President and CEO)

At this point, we're not gonna comment on the partnerships. Obviously, we recognize that integration with the insulin delivery devices is important. Quite frankly, it's not just pumps that are important to us. Of course, there are so many more people that inject with pens. Making that facile is a significant initiative for us as well. We do expect that after the approval, so 2024 impact, that iCGM... not only for the access of those patients, but also just quite frankly, you know, to give the doctors the comfort that there is future in the integration, the iCGM designation is certainly important. Given the timing, there won't be any contribution for 2023, but we certainly see that in 2024.

Sam Eiber (Medical Technology Analyst)

Okay, very good. We'll stay tuned for more. Maybe I can use my follow-up here on the sales force expansion. Tim, I think I call on your prepared remarks that they're also gonna be targeting outside endos into primary care and other settings as well. I guess, is the messaging any different between the two channels? Is one resonating more with the other? Yeah, any more color you can give on the channel expansion? Thanks.

Tim Goodnow (President and CEO)

Yeah, we are looking to, and see, Ascensia is actually creating some new messaging. As, as we've indicated in the past, that certainly continues to be the case, that the majority of our patients are now coming in as type 2, which are treated in different environments and do have different needs and expectations. We are updating the messaging, or Ascensia is updating the messaging, and they'll be rolling that out over the, over the next couple of quarters. That really has been the, you know, the, the key driver that, you know, it's gone on really for the last couple of years. As you've noted, you know, about two-thirds of our patients are now type 2 patients that are coming from different prescribers, and much of them, many of them are coming to us from the DTC efforts that they have in place.

Sam Eiber (Medical Technology Analyst)

Okay, very good. Thanks for taking the questions.

Operator (participant)

Our next question comes from Jason Bedford with Raymond James. Please go ahead.

Jason Bedford (Managing Director and Senior Equity Research Analyst)

Hi, good afternoon. I have a few questions, just kind of maybe all over the place here. What, what percent of the new users are taking advantage of the patient assistance program?

Tim Goodnow (President and CEO)

Rick, can you speak to that? Do we have an update-

Rick Sullivan (CFO)

Roughly.

Yeah. I mean, so it, it was in, you know, less than 50% were taking advantage of the patient assistance program in the first half of the year. Then I think with the UnitedHealthcare coverage effective July, we're gonna see that number decrease going forward.

Jason Bedford (Managing Director and Senior Equity Research Analyst)

Then just getting back to the U.S. number, can we assume that there were more new users added in 2Q than new users added in 1Q? Is that a fair assumption?

Rick Sullivan (CFO)

Yes.

Jason Bedford (Managing Director and Senior Equity Research Analyst)

Okay. Then, you made an interesting comment on the 2/3 type 2. Any idea of, in terms of inserters, what percent are, are endos versus non-endos?

Tim Goodnow (President and CEO)

You know, our, our inserter population is, is now just over 700. The majority are still endocrinology, but outside of endocrinology is, is growing quite fast, and that, of course, includes the, the Nurse Practitioner Group.

Jason Bedford (Managing Director and Senior Equity Research Analyst)

Okay, thanks. Tim, in terms of the 365 day data, are you gonna press release that? Or what's, in terms of disclosure, how will you communicate that to investors?

Tim Goodnow (President and CEO)

I think, Jason, it's probably not best to press release the results from that, given, you know, given that it is an FDA submission. I think what, 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, of the data, it would be acceptable for, for approval. It's generally not a good idea to, to press release the data before it's peer-reviewed and before the agency's had a chance to take a look at it.

Jason Bedford (Managing Director and Senior Equity Research Analyst)

Okay, fair enough. Then maybe, Tim, the last one for you. Bigger picture. Love to get your view on GLP-1s and the impact they may have on your business or the CGM category.

Tim Goodnow (President and CEO)

Yeah. Obviously, it's great to see advances. Diabetes is a significant disease state. We have, we have, of course, seen no impact to date on the utilization of the GLP-1s. Honestly, just given the size, especially for the position that Senseonics has at this point, we don't see it impacting our market opportunity at all. You know, long term, could that be the case? For sure, but not, you know, not over a multiyear horizon at all, especially given the market shares that Senseonics is, is growing from.

Jason Bedford (Managing Director and Senior Equity Research Analyst)

Okay, thank you.

Operator (participant)

This concludes our question-and-answer session, and our conference is also now concluded. Thank you for attending today's presentation. You may now disconnect.