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spk01: Good day, and welcome to the Censionix 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 Tripp Taylor, Investor Relations. Please go ahead.
spk06: Thank you. This is Tripp 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 31st, 2022, our 10-Q for the quarter ended June 30th, 2023, and other reports filed with the SEC. These documents are available in the investor relations section of our website at www.censionix.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 Censionix are Tim Goodenough, President and Chief Executive Officer, and Rick Sullivan, Chief Financial Officer. With that, I would like to turn the call over to Tim Goodenough, President and CEO. Tim?
spk03: Thank you, Tripp, and 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, And our Chief Financial Officer, Rick Sullivan, will provide details on our financials and will 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. Eversince 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 Essentia 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 Essentia 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 growing 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, and 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 are 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 a 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 for insertion, training for physicians who want to prescribe Eversense and insert Eversense for their patients. We continue to support 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 Efficacy Specialist Network, and the traditional prescriber-inserter positions. Building on these initiatives, ABC continues to take active measures to increase access to the patient assistance program. The current program, which offers $99 copay on each of the first two centers, 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 ensures 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. Writing out our progress on access, we recently had a positive coverage decision for implantable CGM from UnitedHealthcare. As of July 1st, 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 ever-since 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 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. And importantly, this is the exact configuration that is 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 enhanced trial is designed to evaluate the accuracy and safety of Eversense for our next-generation sensor, and 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, and positive results from the one-year trial will be a meaningful step forward. As an important milestone and update, we are pleased to announce that we have have recently submitted to the Food and Drug Agency 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. Encionix has a number of development programs currently in place utilizing the planned ICGM designation and we look forward to providing details of these partnerships in the near future. In addition to the enhanced trial for a 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 a 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.
spk04: 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 to 75% of the total ever since revenue generated in the global markets as the revenue share for our partner increases according to our collaboration agreement with Essentia. Sensionics recognizes revenue based on our revenue share when shipments are delivered to Essentia, initiating the multi-step distribution to patients via Essentia 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 percentage due to Essentia, 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 the second quarter of 2022 due to the increased investments in research and development. 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 the second quarter of 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 30, 2023, cash, Cash equivalents and shortened 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 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 S3 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 near-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 to $24 million. Our guidance reflects expected patient growth, which is expected to accelerate in the second half of the year, and a decrease in senseonic share of the ever-since 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.
spk03: 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 Essentia 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.
spk01: 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 Stiefel. Please go ahead.
spk05: 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 essentiality stocking domestically relative to what you were expecting, or were there any other dynamics that didn't play out as you anticipated? And 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.
spk03: Really, the quarterly, as we described earlier in the year, with the inventory dynamics, we did anticipate that Essentia would be optimizing their stocking levels in the first couple of quarters. That certainly has occurred, and this is all part of that transition. The plan, as we've guided to, is a significant ramp in the second half of the year, and we feel well-placed to be in that transition.
spk05: And what gives you confidence 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?
spk03: Yeah, it is predominantly the U.S. growth. Key drivers are, of course, the additional sales reps that Ascentia 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. And 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.
spk05: Great. Thank you very much.
spk01: Our next question comes from . Please go ahead.
spk07: 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 getting that 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? And is it fair to say you'll be working with the two large open pump players?
spk03: Well, at this point, we're not going to comment on the partnerships. Obviously, we recognize that integration with the infant delivery devices is important. But quite frankly, it's not just pumps that are important to us. Of course, there are so many more people that inject with PEN. Making that facile is a significant issue for us as well. So 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, to give the doctors the comfort that there is future in the integration, the ICGM designation is certainly important. So given the timing, there won't be any contribution for 23, but we certainly see that in 24.
spk07: Okay, very good. We'll stay tuned for more. And then maybe I can use my follow-up here on the Salesforce expansion. Tim, I think I caught on your prepared remarks that they're also going to 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? And, yeah, any more color you can give on the channel expansion? Thanks.
spk03: Yeah, we are looking to – Ascensia is actually creating some new messaging. As we've indicated in the past, and certainly continues to be the case, 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. So we are updating the messaging. Ascensia is updating the messaging, and they'll be rolling that out over the next couple of quarters. But that really has been, you know, the key driver that, you know, has 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.
spk07: Okay, very good. Thanks for taking the questions.
spk01: Our next question comes from Jason Bedford with Raymond James. Please go ahead.
spk02: Hi. Good afternoon. I have a few questions just kind of maybe all over the place here. But what percent of the new users are taking advantage of the patient assistant program?
spk03: Rick, can you speak to that? Do we have an update? Roughly.
spk04: Yeah. I mean, so it was in, you know, less than 50% were taking advantage of the patient assistance program in the first half of the year. And then I think with the United Healthcare coverage effective July, we're going to see that number decrease going forward.
spk02: And then just getting back to the U.S. number, can we assume that the There were more new users added in 2Q than new users added in 1Q. Is that a fair assumption? Yes. Okay. And then you made an interesting comment on the two-thirds type 2. Any idea of, in terms of inserters, what percent are endos versus non-endos?
spk03: You know, our insertor population is now just over 700. The majority are still endocrinology, but outside of endocrinology is growing quite fast, and that, of course, includes the nurse practitioner group. Okay.
spk02: And then, Tim, in terms of the 365-day data, are you going to – press release that, or what's, in terms of disclosure, how will you communicate that to investors?
spk03: I think, Jason, it's probably not best to press release the results from that, given that it is an FDA submission. 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 that would be acceptable for approval. But it's generally not a good idea to press release the data before it's peer-reviewed and before the agency's had a chance to take a look at it.
spk02: Okay, fair enough. And 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?
spk03: Yeah, so obviously it's great to see advances. Diabetes is a significant disease state. We have, of course, seen no impact to date on the utilization of the GLP-1s. And then honestly, just given the size, especially for The position that Syncyonics has at this point, we don't see it impacting our market opportunity at all. You know, long-term, could that be the case? We're sure, but not, you know, not over a multi-year horizon at all, especially given the market share that Syncyonics is growing from. Okay.
spk02: Thank you.
spk01: 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.
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