SENS - NASDAQ

Good day, everyone, and welcome to the Senseonics Third Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note, this call may be recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Jeremy Feffer, LifeSci Advisors.

Thank you. This is Jeremy Feffer from LifeSci Advisors. 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 these 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, 2023, our quarterly report on Form 10-Q for the quarter ended September 30, 2024, and our other reports filed with the SEC. These documents are available in the Investor Relations section of our website at www.sensionics.com. We undertake no obligation to update publicly or revise these forward-looking statements for any reason except as required by law. Joining me today from Senseonics are Tim Goodnow, President and Chief Executive Officer; and Rick Sullivan, Chief Financial Officer. Today, we also have Brian Hansen, President of CGM at Ascensia Diabetes Care, our global distribution partner for Eversense joining us. With that, I would like to turn the call over to Tim Goodnow, President and CEO. Tim?

Thank you, Jeremy, and thank you all for joining us this afternoon. During our call today, we'll begin with a recap of what an exciting and pivotal quarter it has been for Senseonics. We'll also hear from Brian who is responsible for the rollout of our recently approved Eversense 365, the world's first and only one year continuous glucose monitor. Lastly, Rick will review our third quarter financials and then we'll take any questions you might have. On September 17, we received FDA approval for the Eversense 365, marking a significant accomplishment many years in the making. When we designed our 90-day and 180-day CGM products, we were always working towards the goal of One CGM for one year. A goal that seemed imposing at the time. We did the market research and knew what patients and prescribers wanted convenience, flexibility and longevity, coupled with accuracy and reliability. We set out to deliver all of these things to help people overcome common frustrations and interruptions experienced with traditional short-term CGMs. Early feedback we've received from patients and clinicians is extremely positive and the lead generation that we have seen in the first month of the launch as well exceeded expectations. In the first week alone, we saw the highest influx of leads in the company's history indicating that the diabetes community is embracing Eversense 365. And as you may have heard during our KOL call a couple of weeks ago, endocrinologists see the opportunity for Eversense 365 across Type 1 and Type 2 diabetes. Doctors Anh and Ciaramita also agreed that for some people with diabetes, Eversense 365 is the only CGM that makes sense. For example, patients with difficulty hearing audible sensor alarms, patients with allergies to common adhesive materials used with short-term CGMs, and patients who are physically active and tend to lose sensors before the end of their stated expiration date. During the KOL event, we also heard from Mercy, the first hospital system to adopt Eversense 365 as part of a system wide solution. Mercy with over 30,000 patients who could benefit from this CGM believes that Eversense will improve outcomes for patients as well as decrease overall costs related to diabetes care. We believe that the Mercy collaboration can bring a model for other healthcare systems to follow and we hope to enter into additional similar collaborations with other health systems in the coming year. By offering Eversense 365 to its participants and arranging access to our remote patient monitoring program health systems can offer patients more ongoing support than providing a CGM device alone. As RPM leverages personal data to inform diabetes counselors who could proactively advise patients on improving their diabetes management. These professionals are intended to provide coaching and insight into things impacting patients' glucose levels such as medications, foods, exercise and lifestyle. And that will allow patients to make better informed decisions. And the program is designed to coach and interact with patients between physician visits. This is intended to shorten the feedback loop of information patients receive. Our goal is for the Eversense CGM and RPM offerings to help health systems improve diabetes management and reduce the cost of care. On the reimbursement side, Eversense 365 is covered by nearly all U.S. private insurers as well as Medicare covering over 300 million lives in aggregate. We have seen strong adoption by commercial payers and continue to work with a few smaller regional insurers to expand coverage as broadly as possible. I'm so proud of the Senseonics team and all the hard work put into delivering the world's first and only one year CGM, but our work doesn't stop here. Our pipeline includes the Gemini sensor incorporating battery power for continuous 24/7 readings, as well as the Freedom sensor, which communicates directly with a patient's phone with no transmitter required. We're making progress in our development programs to integrate these exciting enhancements into the Eversense system and we continue our mission to improve the patient experience and reduce life disruptions that glucose monitoring can cause.

To get a bit more granular for a moment, our immediate priorities include increasing awareness through optimizing our creative efforts and targeting to cost-effectively drive high quality prospects to the Ascensia website. Our website has been fully updated to allow easier navigation for better access to product information, education, training and cost and insurance details. These improvements are designed to help increase lead capture for qualified, high-scoring prospects, nurturing and expanding outreach approaches to leads to better reach them and optimizing end-to-end processes and training to improve customer experience and drive conversion. As a result of these efforts, we saw healthcare provider and our direct to consumer leads increased by more than 200% in the four weeks post 365 approval compared to the four weeks prior to approval. Speaking of customer experience, I want to share with you some of what we've been hearing in the field. First of all, their primary reaction we've seen and heard is enthusiasm. We believe we have the best product in the world and our reps are tremendously excited to carry Eversense 365 in their bag. Secondly, we are seeing real enthusiasm from our healthcare providers. As I mentioned earlier, the referrals of new patients have more than doubled. In addition to encouraging those using the 180 day sensor to transition to 365 when their six months sensor has expired, this is opening doors to us where we've had little to no access. Lastly, I've seen many successful, as well as some not so successful launches in the diabetes space and the buzz and buildup around this one certainly has me excited. There is one other aspect of Eversense 365 that I know will resonate extremely well with both patients and physicians reduced calibrations. Once weekly calibration is a marked improvement over previous Eversense generations and now does not differ much from the transdermal insertion necessary with short-term CGMs that are replaced every 10 to 14 days. I believe the reduced calibration requirement will make the Eversense 365, a much more competitive offering and early feedback confirms our market research that once a week calibration should benefit Eversense adoption, particularly given the enormous convenience benefit of a year long sensor. As I mentioned, Ascensia is proud to partner with Senseonics to make Eversense 365 available to patients globally. We believe in the product and its potential to improve both the experience and the outcomes for patients with diabetes. With that, I'll hand it back over to Tim.

Thank you, Brian. It's great to have you here and thanks for your invaluable efforts to date. To follow on Brian's comments, in terms of the actual commercial launch, I want to remind everyone that the first commercial insertion of Eversense 365 took place in early October and we are just beginning to ship 365 sensors into the channel more recently. As a result, third quarter revenue we are reporting today is all pre-Eversense 365. Fourth quarter, U.S. revenue will be a mix of E3 sales from its final shipments and the initial shipments of 365, meaning we will not see the full impact of 365 revenue in the U.S. until Q1 2025. We continue to serve the European market with E3 and expect in the first quarter to submit 365 for its CE mark in Europe. While we will not be providing 2025 revenue guidance until our next earnings call, I can tell you that we are ecstatic with the early response to 365 that we've received from patients and physicians this far, and we are looking forward to an exciting and successful year ahead. With that, I'll now turn it over to our CFO Rick Sullivan, who will provide more details on our financial results, recent financing activities and our restructuring efforts. Rick?

Thank you, Tim and good afternoon, everyone. We appreciate the opportunity today to update you on our business. In the third quarter of 2024, net revenue was $4.3 million compared to $6.1 million in the prior year period due to the inventory dynamics associated with the 365 day product launch, where we've sought to reduce U.S. E3 inventories in anticipation of the transition to the 365 day product. U.S. revenues for the Q3 was $2.4 million and revenue outside the U.S. was $1.9 million. As a reminder, our collaboration agreement with Ascensia is for revenue sharing, with the percentage of revenue to Ascensia increasing based on duration of the contract and annual revenue levels. We recognize our portion of revenue when shipments are delivered to Ascensia and they take title and ownership of the inventory. This begins the multistep distribution to patients via Ascensia and their distributors. We manage our manufacturing based on patient demand generated from commercial activities, targeting 60 to 90 days of inventory across the various channels. Therefore, our shipments to Ascensia during the quarter are largely intended to support future demand for Eversense. Third quarter shipments were intended to support the file demand for the U.S. 180 day systems. We began the planned transition to the 365 day product launch in the fourth quarter. We do not expect to reach target inventory levels for 365 day product in the fourth quarter, and will gradually increase inventory to target levels through the first half of 2025. Gross loss in Q3, 2024 was $4.1 million, a decrease from a gross profit of $1.2 million in the prior year period. This decline was primarily driven by one-time charges associated with the transition of Eversense E3 to Eversense 365. Research and development expenses in Q3, 2024 were $10.5 million, a decrease of $2.3 million compared to $12.8 million in the prior year period. The decrease was primarily due to the completion of the enhanced clinical trial, which drove a $2.6 million reduction in clinical study costs over the prior year period. Third quarter 2024 selling, general and administrative expenses were $8.3 million, an increase of $0.9 million compared to $7.4 million in the prior year period, primarily driven by increased personnel and consulting costs related to Eon Care and other commercial efforts to support Ascensia. For the nine months ended September 2024, operating loss was $22.8 million compared to $19 million in the third quarter of 2023 due to inventory write-offs associated with the transition to the 365 day product, offset by a reduction in clinical trial costs. For the three months ended September 2024, total net loss was $24 million or a $0.04 loss per share compared to a net loss of $24.1 million or a $0.04 loss per share in the third quarter of 2023. Net income increased by $0.1 million due to the reduction in R&D expenses. As of September 30, 2024, cash, restricted cash, cash equivalents and short-term investments totaled $74.8 million and debt and accrued interest was $55.9 million. In Q3 and in early Q4, we raised gross proceeds of more than $20 million, including the $16 million offering announced in October. These financings improve our current balance sheet and provide us the flexibility to repay the 2025 notes due early next year, significantly reducing our outstanding debt. In October, we also executed a restructuring that included a reduction in force of nearly 20% and a planned reduction in operating expenses with a target of reducing cash operating expenses with a target of reducing cash operating expenses by more than $10 million in 2025. These efforts combined extend our cash runway for over a year into late 2025. We also recently acquired the Eversense Insertion Network assets of the nurse practitioner group and have begun the transition to our Eon Care subsidiaries. As we work to grow this network, we believe the opportunity of the CPT code payments associated with the insertions will enable a self-sustaining economic model for this initiative. We anticipate that having further influence over the insertion process through this strategic move will drive efficiencies, increase insertion throughput and ensure continued focus for an excellent patient experience. The acquisition will have a minimal cash impact to our Q4 financials. Turning to our outlook for the remainder of 2024, Senseonics expects full year 2024 global net revenue to be approximately $22 million, as we begin to transition our U.S. products to Eversense 365 following its approval in late Q3. The full year 2024 financial outlook assumes more than doubling the U.S. new patient starts and increasing the global installed base by approximately 50% in 2024 compared to 2023. Inventory dynamics associated with the 365 day product launch impacted product sales in the third quarter as we began reducing E3 inventory in anticipation of the transition to Eversense 365. Sales are expected to accelerate in the fourth quarter based on anticipated initial 365 day product demand and the initial ramp of the Mercy collaboration. While we're not yet providing guidance for 2025, we're confident that based on early lead generation Eversense 365 revenue growth should accelerate further in 2025 when it will be the only product sold in the U.S. We also continue to expect gross margins for 2024 to be in the range of 10% to 15%, excluding the $4.8 million of one-time charges associated with the transition to the 365 day product. We're really excited about the unit economics of Eversense 365 and expect our gross profit margins to meaningfully improve almost immediately approaching 30% next year. We expect our operating expenses for 2024 to continue to be in the range from $77.5 million to $82.5 million. For 2025 we expect to see cash operating expenses decrease by $10 million compared to 2024 as a result of the recent restructuring efforts. With Eversense 365 on the market and the expected positive margin contribution will work to ensure that the organization is right sized and staying disciplined in our use of capital, while remaining positioned to support both our commercial partner in driving adoption of Eversense and our important work progressing our product pipeline. With that, I'll turn it back to Tim.

Thanks, Rick. And as I mentioned at the start of the call, we feel confident in Senseonics’ future trajectory. We are well positioned as we head into the final quarter of the year with a solid foundation of new approvals, launch momentum and a strengthened balance sheet. We see the opportunity to drive growth through the delivery of our strategic initiatives. We're executing our development and operational initiatives, while Asencia continues to enhance its commercial capabilities. Further, we are building from the strong foundation of our differentiated technology in a pipeline that has continuously advanced next generation products. The successful clearance and now the launch of our 365 day product represents one of the most significant catalyst in the company's history, and we're looking for 2025 to be a transformational year for the company. There is a large opportunity in front of us, and as we work to continue to simplify the lives of more people with diabetes and build higher growth and shareholder value.

We'll move next to Vernon Bernardino of H.C. Wainwright.

Yes, Vernon. So we are transitioning the market very quickly. In the U.S. it's pretty much a light switch, right. We're -- if you're up next for a sensor, you're going to go to the 365. Europe of course is going to take a little bit longer because we are seeking the approval to commercialize over there. But it's essentially immediate for obviously all new patients. But anybody that's coming off a 180, their next sensor will be 365.

Thanks for taking my question and congrats on the results looking forward to meeting this third quarter -- I mean the fourth quarter.

Thank you. This does conclude our question-and-answer session. I'd be happy to return the call to Tim Goodnow for closing comments.

Well, thank you for the opportunity to speak. We appreciate it and we look forward to updating you on our next quarterly call in Q1. Thank you.