SENS (2019 - Q4)

Good day and welcome to the Senseonics Fourth Quarter and Full Year 2019 Earnings Conference Call. All participants are 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 Philip Taylor, Investor Relations. Please, go ahead. Philip T

Thank you very much and welcome to the Senseonics fourth quarter and full year 2019 earnings call. This is Philip Taylor from the Gilmartin Group. Before we begin today, let me remind you that the company's remarks include forward-looking statements. These statements reflects 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 all Annual Report on Form 10-K for the year ended December 31, 2018, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and other reports filed with the SEC. These documents are available within 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. Also, on this call, we will be discussing our full year 2020 revenue guidance on a gross and net basis, which was also included in the press release. In light of Regulation FD, we advise you that it is Senseonics policy not to comment on our financial guidance other than in public communications. On this call, we will be providing investors with U.S. GAAP net revenues and gross revenue measures to provide meaningful supplemental information regarding our performance and provide better transparency on our impact of reimbursement in the Eversense Bridge program. In accordance with U.S. GAAP, Senseonics reports revenue in its financial statements on a net basis, which includes gross to net reductions, primarily related to the Eversense Bridge program. Gross revenue measures do not reflect the gross to net reductions and accordingly may be considered to be non-GAAP financial measures. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for or superior to the financial information prepared and presented in accordance with U.S. GAAP and Senseonics non-GAAP measures may be different from non-GAAP measures used by other companies. For more information on these non-GAAP financial measures, please see the reconciliation of these non-GAAP financial measures to their nearest comparable GAAP measures in this afternoon's earnings release, which is available on our corporate website at senseonics.com. Joining me from Senseonics are Tim Goodnow, President and Chief Executive Officer; and Nick Tressler, Chief Financial Officer. With that, I would like to turn the call over to Tim Goodnow, President and CEO. Tim?

Thank you, Trip. Good afternoon and thank you all for joining us. On the call today, I'll provide a recap of our accomplishments in 2019, discuss progress and updates on our commercial and operational initiatives and provide our financial outlook for 2020. Nick will then provide details on our fourth quarter financials and we'll conclude and open the call for Q&A. In our first full year of commercialization in the U.S., in 2019 we made significant progress in delivering our revolutionary technology to people with diabetes. We established capabilities focused on increasing awareness and access and continued to gain incremental reimbursement and established a distribution network through our channel partners. A couple of key accomplishments include, that we've expanded the professional awareness of Eversense among endocrinologists through direct outreach, engagement and presentations at diabetes medical conferences. We've also increased consumer awareness through our use of direct-to-consumer digital marketing campaigns. We've added a significant number of covered lives with national payer wins including Aetna, Cigna and Humana and importantly established the Medicare coverage category as a medical benefit, avoiding the complex and burdensome DME category. We implemented a Bridge access program to accelerate patient access for those who have not yet received reimbursement for Eversense or those that may have a high out-of-pocket co-insurance. And we've also launched a certified Eversense Specialist Program to train and create a network of healthcare professionals in specialties beyond endocrinology on the insertion procedure, further expanding access pathways for patients. On the clinical and regulatory front, we've achieved the non-adjunctive label from the FDA, thereby allowing patients to dose their insulin based off Eversense readings and we receive the important MRI indication. We have also extended the insertion and removal certifications to NPs and PAs, expanding capability within the clinics. We've had four seminal articles published in peer-reviewed journals, highlighting the real-world clinical safety and efficacy of Eversense. And finally, we've completed enrollment in the PROMISE study for the 180-day sensor and have received authorization from the FDA to extend the trial in a subgroup out to 365 today. We are extremely proud of these accomplishments. Throughout 2019, each of these milestones contributed to healthcare professionals and patient adoption, which ultimately drove our full year net revenue of $21.3 million. And full year gross revenue of $26.2 million before the U.S. gross-to-net reduction of approximately $5 million. Although, we don't realize this $5 million of additional net revenue, we certainly do realize that its value in additional installed base, additional patient experience and incremental product use demonstrated to the payers. We are confident that our investments will continue to serve an important building block of success, as we grow the business. In the U.S. market, our patient base in 2019 reached approximately 4,000 patients. Feedback on Eversense is clearly strong from both the patient and the HCP communities. Expanded clinician awareness is demonstrated by the increased number of prescribers, which is now up to over 1,800 and the increased number of HCPs trained and inserting which is now over 500. This represents significant penetration within the targeted population of insulin prescribing endocrinologists and treating physicians. For those prescribers wanting to offer Eversense to their patients, but are not yet trained on the procedure, a Certified Eversense Specialist or CES program provides local access to train professionals and other specialties with these insertions. These trained inserters are not only familiar with the office-based procedures, but they are also very familiar with the billing practices and can bill for their professional time under our CPT codes. We are pleased that this program opens up an additional access path for patients. We currently have approximately 120 CES providers and this population continues to grow. As we have described before, increasing access is naturally one of the key components of our commercialization strategy and we have been successful here by generating additional patient pull, as well as adoption through our Bridge access program. This program allows eligible patients to obtain up to two Eversense sensors or six months of CGM for only $99 per sensor. We initiated the program to achieve several key business objectives. First, because we know that many patients who try Eversense quickly become passionate advocates, we are accelerating the number of patients experience the benefit and sharing their experiences online. And expanding patient base also facilitates our second goal of ensuring healthcare professionals similarly gain more experience with the clinical benefits for their patients. Finally, we have shown that the Bridge program is instrumental in demonstrating the products demand to payers. We are confident that the volume of voices and the claim activities were influential in the recent coverage wins, we received by payers such as HCSC, Humana and Cigna. In 2019, we provided access for patients whose insurance did not cover Eversense, as they were E&I. This group represented 45% of our patients. In addition, another 17% received some form of partial payment through the program, typically supporting patients who had not yet met deductibles. The utilization of the program by 62% of the patients was primarily responsible for the reduction of the gross revenue of $8.1 million to $3.2 million net revenue for the full year in the United States. The Bridge program has also helped to demonstrate true market demand. It is increasingly clear that traditional CGM devices are not meeting the needs of all patients. In addition, during the past year, one-third of our patients came from finger-stick testing. We are also pleased that while the program provides assistance for two sensors, the majority of patients are continuing with additional sensors after the programs end. Even patients entering the program from a payer who does not cover Eversense, the majority of these patients continue on with additional sensors. We note that patient satisfaction is high, encouraging many patients to move forward after having tried Eversense. Importantly non-covered patients are enrolled into the appeals arm of the program. This part of the program serves as the patient advocate initiating appeals and single case negotiations for the individuals. Here we have seen success as well. To date 54% of the patients that have been fully enrolled into the appeals program have gone through the full appeals process with the remaining patients still in pursuit. Of those who have completed the appeals process, over 90% have resulted in successful approvals enabling those patients to receive coverage and continue with Eversense despite their payer maintaining a broad-based non-coverage policy. While the patients continuing to be on Bridge, we are building a strong installed base of patients positioned to convert to full revenue patients as their payers begin covering Eversense. A great example of this would be Cigna who made a positive coverage determination this past month because of the program we have a positive head start on building the installed base of Cigna patients will now be covered going forward. Finally as we mentioned on the last call, CMS with 61 million Medicare beneficiaries clarified that benefit category and payment rates for our CPT code for Eversense as part of the calendar year 2020 rule-making process. Notably CMS determined that the implantable CGMs are now categorized as Part B medical service, meaning they will not be processed through the durable medical equipment benefit like other CGMs. Doctors will be able to bill Medicare directly for a single wrapped patient -- payment that includes both the system and their professional time for the sensor insertion and removal. With the CMS ruling, we petitioned the seven Medicare Administrative Contractors or MACs to remove our category three codes from the original noncovered list. The removal activity is in the prioritization process at the MACs and we anticipate action in the coming months. Key to growing our business is growth in the United States. And in 2020 we are carrying positive momentum from 2019, which we anticipate will result in an additional over 5,000 new patients in the coming year. Increasing patient awareness led by our growing installed base of passionate users and a growing group of both prescribing and inserting physicians, as well as broader coverage and our mounting evidence of clinical outcomes are all tailwinds created in 2019 and we believe will be growth drivers going forward. Given the success of the Bridge program and supporting patient adoption in 2019, we have made the decision to continue the investment in 2020. With approximately nine months of experience, we have seen favorable reinsertion rates and the breaking down of financial barriers, which drives positive patient experience for growing the installed base. At this point, we are projecting an approximate 60% blended utilization for the full year 2020 with gross-to-net adjustment rates stepping down each quarter as additional payers cover Eversense and deductibles are met. Outside the United States, our fourth quarter revenue totaled $8.1 million and was $18.1 million for the full year. As you know, the vast majority of the OUS revenue is from our distribution agreement with Roche. Based on customer feedback we know that many Eversense XL users continue to be satisfied with the product. And as presented in the real-world evidence, clinical outcomes such as time and range and mean wear time are high and remain high over multiple sensor cycles. As we reported in December, we amended the Roche contract to reduce the minimum purchase requirements for 2020 while increasing price. We agreed to this arrangement to account for Roche's higher inventory levels at the warehouse where they had purchased product based on their contractual minimum purchase requirements, which exceeded the quantity of product that Roche sold to the end user. One particular challenge they are facing is in some markets for example is a provider procedure payment. While there was high payer coverage Eversense in Germany and greater than 90% of covered lives there are no CPT codes like in the United States to allow for billing of the procedure by providers. In working with Roche to determine additional push and pull-through programs to place Eversense in the hands of users, both Roche and Senseonics are committed to understanding how to improve access and utilization of our long-term technology in Europe. We do expect this contract amendment will have notable impact in reducing this year's purchase volume from Roche. Additionally, we are currently in discussions with Roche regarding inventory, sensor longevity issues and the timing of their 2020 purchase orders. There are substantial risks that their first quarter purchases may be deferred to later in the year. While we believe Roche is contractually obligated to place a minimum order during the first quarter. If they do not our OUS revenue for Q1 2020 would be de minimis. In regard to our overall outlook for the year, which reflects a 33% reduction in Roche revenue as a result of the amendment to the Roche contract. We are anticipating gross revenue to be in the range of approximately $25 million to $30 million for the year. In the U.S. with the GAAP revenue reduction for the Bridge expenses, we are forecasting net revenue to be up approximately 100% over year. In total in the U.S. and with the outside the United States contribution, we expect full year net revenue to be in the range of $15 million to $20 million. Moving on to product development. Here our top priority continues to be the PROMISE study where the 180-day sensor is completing investigation of 181 patients across eight sites. This is another giant step for our CGM and execution of this trial has been positive to date as expected. Tracking according to plan, we expect to have the last patient out within the next three weeks and will work to prepare a submission to the FDA in the months following. Therefore placing potential product approval towards the end of 2020 and in line with previous expectations. As a reminder, we intend to use the patient data from the first 90 days of the trial and an interim analysis to support a settlement submission for the iCGM designation for the current 90-day sensor. We expect to file this later in the second quarter. In addition, we announced in recent news that we have signed a development agreement with Companion Medical to integrate Eversense real-time glucose data with a Companion Medical InPen smart system for insulin delivery. Although, integrating Eversense CGM data with insulin pumps is still part of our strategic plans once we receive ICG approval. The market penetration for insulin pens is considerable as well. More than 65% of the diabetes market still use daily injections to administer their insulins. Partnering with InPen, we're able to start addressing a larger market with real-time CGM values alongside with their insulin values, thereby allowing for more relevant insulin dosing information to inform improved diabetes management decisions. We're excited to see another integrated solution for people with diabetes is in both novel new technologies. Finally, as part of our ongoing commitment to increase uptake of our product, we are exploring potential collaborative and partnership opportunities to better make Eversense available to people with diabetes. In addition in an effort to accelerate the development of our Flash implantable system with no on-body transmitter, we are currently engaging with potential partner organizations to discuss the co-development and eventual co-commercialization of this next-generation technology. We are designing this next-generation sensor for people that are looking for continuous sensing capability without having to wear an additional on-body component. Now I'll introduce and turn the call over to Nick Tressler. As we announced on the call last quarter, Nick has been with the company for over a year and was promoted from the Head of Financial Planning and Analysis to Chief Financial Officer in November. He has deep financial leadership background from across life science companies of various sizes. We are happy to have Nick leading the finance organization and he will now provide the details on our recent results. Nick?

Thank you Tim and good afternoon everyone. I'm excited about the opportunity to take a larger leadership role with this management team to continue to progress Eversense into the marketplace and maximize the value of Senseonics. I look forward to further conversations with more members of the investment community in the near future. Now, turning to our results. In the fourth quarter of 2019, total net revenue was nearly $9 million, which includes U.S. net revenue of $800,000 after accounting for gross to net reductions, primarily related to the Eversense Bridge Program and OUS net revenue of $8.1 million, compared to the fourth quarter 2018 total net revenue of $7.2 million. Fourth quarter 2019 total net revenue grew 25% compared to the prior year period. Gross revenue for the fourth quarter of 2019 was $10.7 million, including U.S. gross revenue of $2.5 million. Gross profit in Q4 2019 decreased by $3.3 million year-over-year to negative $8.2 million compared to negative $4.9 million in the prior year period. The decrease in gross profit was primarily due to increased cost of sales expenses, including charges for obsolete inventory and product enhancements, warranties and costs to streamline the sensor supply chain. Fourth quarter 2019 sales and marketing expense increased by $0.7 million year-over-year to $11 million compared to $10.3 million in the prior year period. The increase was due primarily to commercialization efforts in the U.S. Research and development expense in Q4 2019 increased by $1.7 million year-over-year to $9.7 million compared to $8 million in the prior year period. The increase was primarily driven by the 180-day PROMISE clinical study. General and administrative expense in Q4 2019 was $5.9 million, an increase of $0.6 million compared to the prior year period and includes compensation, legal and other expenses supporting operational growth. For the three months ended December 31, 2019 total net loss was $35.6 million or $0.18 per share compared to $7.3 million or $0.04 per share in the fourth quarter of 2018. For the full year 2019 net revenue was $21.3 million, which includes U.S. net revenue of $3.2 million after accounting for gross to net reductions, primarily related to the Eversense Bridge Program and OUS net revenue of $18.1 million, compared to total net revenue net of $18.9 million for 2018. Full year 2019 total net revenue grew 13% compared to 2018. Gross revenue for 2019 was $26.2 million including U.S. gross revenue of $8.1 million. 2019 gross profit decreased by $11.3 million year-over-year to negative $19.4 million. The decrease in gross profit was primarily due to increased cost of sales expenses including charges for obsolete inventory and product enhancements, warranties, cost to streamline the sensor supply chain and cost for warehousing and logistics. Sales and marketing expenses for the year ended December 31, 2019 increased $21.8 million year-over-year to $49.6 million compared to $27.7 million for 2018. The increase in sales and marketing expenses was primarily related to increases in personnel-related costs and activity to support the U.S. commercialization of Eversense. Research and development expenses for the year ended December 31, 2019 increased $6.6 million year-over-year to $38.4 million compared to $31.9 million for 2018. The increase in research and development expenses was primarily driven by the 180-day PROMISE clinical study costs. General and administrative expenses for the year ended December 31, 2019 increased $3.4 million year-over-year to $23.2 million compared to $19.8 million for 2018. The increase in general and administrative expenses was driven primarily by an increase in personnel-related expenses, increased legal and audit expenses and other costs associated with supporting a growing operational infrastructure. Net loss was $115.5 million or $0.61 per share for the year-ended December 31, 2019 compared to $94 million or $0.60 per share for 2018. Net loss per share for 2019 was based on 188.8 million weighted average shares outstanding compared to 157.4 million weighted average shares outstanding for 2018. From a balance sheet perspective, as of December 31, 2019, our cash and cash equivalents were $95.9 million. Outstanding indebtedness was $144.9 million. Turning to guidance, as Tim provided previously, global net revenue for full year 2020 is expected to be in the range of $15 million to $20 million. This includes year-over-year net revenue growth of approximately 100% in the U.S. and revenue decreases of approximately 33% in the OUS, relating primarily to a reduction in sales to Roche as a result of the amendment of our distribution contract. It also includes the impact of gross-to-net reductions, primarily for the Bridge patient access program, which is expected to be approximately 60% reduction from gross-to-net for the full year in the U.S. In regards to the cost structure including OpEx and COGS, we estimate our restructuring actions taken in Q4 will reduce expenses in 2020 compared to 2019 by the low to mid-$20 million range. On the Q3 earnings call, we said we had cash on hand through 2020. Based on our updated projections including the impact of the Roche amendment, we now project cash on hand to last into Q4 of 2020. Turning to our existing borrowings, as we have previously disclosed under our senior credit agreement with Solar Capital, we are required to meet a number of covenants including a trailing six-month minimum product revenue covenant. Although we were in compliance with all covenants as of December 31, 2019 based upon our contract expectations for the remainder of first quarter of 2020, we expect that we will be in non-compliance with the trailing six-month revenue covenant as of the end of March. Our earnings release and our annual report on Form 10-K to be filed on or before March 16 includes additional details. I will now turn the call back over to Tim.

Thank you, Nick. As we reflect on 2019, I am encouraged by the progress we have made in several areas to build Eversense and lay the foundation for its future growth particularly in the United States where we see strong patient loyalty with material progress with payers and expanding patient and physician awareness. At the same time, I am mindful of key disappointments. This year's European revenue specifically. We are committed to focusing on improving the situation. We do directly see the excitement around the product in the United States, where in the first full year we were able to bring the 90-day product to approximately 4000 people. Unfortunately progress has not been at the same level in Europe. Here we've brought the 180-day product to over 7,500 patients over the last three years. To address this, we will work on changes needed to be successful outside the United States, while at the same time continuing to drive expansion of Eversense in the U.S. We do recognize that the largest opportunity is here in the States. And this success is the greatest opportunity to serve patients and build value. We have made solid progress on the 180-day product nearing completion of the clinical trial. We believe its anticipated introduction will be an important inflection point for our business. And as noted to accelerate a transmitter list Flash CGM, we will continue to evaluate collaborations and other opportunities to best advance the company, the product and our pipeline for the future. With that this concludes our prepared remarks. Joining us for questions are Mukul Jain, our Chief Operating Officer; and Mirasol Panlilio, Vice President and General Manager of Global Commercial Operations. Operator, let's open up the call for questions.

[Operator Instructions] The first question comes from Danielle Antalffy of SVB. Please go ahead.

Hey, good afternoon guys. Thanks for taking the question. Can you hear me, okay?

Hey, Danielle, how are you?

Okay great. Thanks so much. I'm good. Thank you hanging in there, hope you guys are too. Just a question on the U.S. ramp. I mean it feels like from a patient perspective, momentum is building. But I guess my question is when do you start getting paid for these patients because that's where the revenue shortfall seems to be coming at least relative to our model. So just want to get a sense it seems like you're at critical mass from a coverage perspective, when do we get beyond this overhang of the Bridge program and you actually start generating meaningful revenue from the patients that you're bringing on board?

Yes. Good point, Danielle. And clearly the gross-to-net has obviously got the biggest impact on the true net revenue performance of the business of course. As we said, about 45% of the patients in 2019 that came to the product were on a full E&I. So we supported them with the Bridge program. And in addition another 17%, although they had coverage either had high deductibles or other considerations such that they participated in the Bridge program. So two things, we certainly expect as we've had now additional wins and many of them were late in the year like Humana, HCSC obviously and -- excuse me, Cigna did not even come until February of this year that will normalize over the rest of the year, but we also have to understand the -- quality that here it is in the first quarter. Deductibles are reset and there will continue to be utilization. So we do expect that it will transition down this year, but given the patients that we brought in, we think it continues to make sense to utilize it.

Okay, got it. That makes sense. And then just a question, I know this is like evolving daily for everyone. But COVID-19 and what you're reflecting in guidance, a little bit more specifically. I know from a diabetes patient perspective you don't have the same hospital procedure volume impact. But if people stop going to the physician's office, going for checkups that could slow new patient adds. I mean, how do we think about what's reflected in the guidance you're giving today? And I guess risk to that as this situation continues to evolve? Thanks so much.

Yes, I understand fair comments Danielle. Certainly from a supply continuity perspective, we've certainly got the analysis. At this point the majority of the product is actually manufactured or pre-stage manufactured in England and is transferred here for very final assembly and sterilization. So we haven't seen any supply continuity concern, we do have a couple of months' worth of inventory that are in process, which of course is immediately available to us and we were working through. From a societal impact here in the U.S., obviously, we're watching that very closely as of course everyone is. If it gets to the point where people are not going to go to the doctor or -- impact such as that then we'll certainly need to see that develop. At this point, we're forecasting the best information we have, but we'll certainly look to make any updates as that make sense. And as you suggest this is really a dynamic of the state that we're in really independent of the individual companies.

Thank you.

The next question comes from Jayson Bedford of Raymond James. Please go ahead.

Hi, good afternoon. Just a few questions for me. I guess, just you may have mentioned it, but how much inventory does Roche have right now?

We don't actually Jayson have their supply inventory. We don't have that close access to it. We did speak with Roche towards the end of the year where they indicated that their inventory had notably backed up due to what they were able to move out in the third and fourth quarter of last year. So we've made a reduction to make sure that we don't continue to bill that inventory especially as the contract currently only goes for the next 12 months or so, 11 months or so. And we certainly didn't want to leave a bunch of inventory at that point. So I'm -- unfortunately I can't directly answer you, but we do know that they informed us that it gotten high at the -- in the second half of last year.

Okay. A couple more numbers related questions. You mentioned that you've brought on 7,500 patients in Europe on the 180-day is that the installed base that we should build on going forward into 2020 here?

Obviously it's the installed base that we use, but we also do need to understand that there is the normal turnover right? We've indicated that it's about 75% on first sensor into the high 80s on second sensor, and then into the 90s in 30 and beyond. So that model should work.

Okay. And you mentioned, I think over 5,000 new patients expected or new users expected in 2020. Can we assume that the vast majority of those are in the U.S.?

Yeah. For clarity those are all in the U.S. Jayson.

Okay.

I don't have an ability to give you guidance in Europe, but that's all U.S. patients.

Okay. That's fair. And then in terms of the expected time lines on the partnership opportunity both on whether it be just normal distribution on the 180-day or the Flash product. What's the time line investors should expect here?

Yes. Unfortunately Jayson, I'm not able to give you a time line and as you can imagine these business development conversations can certainly take time. So, I'd like to not forecast it at this point as -- and they can go back and forth as I'm sure you understand.

That’s fair. I'll jump back in queue. Thank you.

The next question comes from Mathew Blackman of Stifel. Please go ahead.

Thanks and good afternoon everybody. It doesn't sound like Rudy is there. So, maybe Tim, you can help me with this. I'm just curious, as I think about sort of the U.S. commercial strategy, how is that evolving? And now that Rudy is in that seat, what changes whether you task in what changes perhaps could be in-store in the U.S.? And I guess sort of the follow-up is that, how do we -- how would you have us best measure your progress in the U.S.? Obviously, things get a little bit noisy with a gross-to-net. But should we just be looking at gross revenue growth in patient adds? What are you using to track your progress in the U.S. particularly here in 2020? And then I have one follow-up.

Sure. Well, I do try to focus -- I personally do look at the gross revenue, although it doesn't truly meet the accounting GAAP standards because of the nature of it. The gross revenue is representative of the amount of product that we are sending to patients. Unfortunately, we do have to net the deduction because we are subsidizing it instead of the insurance company. But we do feel there's good strong patient demand there. And as we knock off these payers, we are seeing that we're able to convert them to revenue generating. Now, from a commercialization, as you know or as you may recall, our focus in the first year really was on the physician demand, physician education and training especially with the high prescribers. I think we were very successful there. And most of the folks that are very high prescribers of insulin or CGM are well aware of Eversense and using it. What we've done more recently and Rudy has done a very good job with, is now after that first year's time period, he's creating the patient pull forward as well. So, the marketing team has done a very nice job with direct-to-consumer advertising to the point now, where about half of our sensors are generated from the direct-to-consumer activities and the other half is generated from the sales reps calling on the physicians as they traditionally had done. So, we've done a nice job of reaching that balance. As you know, in the last call, we did announce some restructuring of the sales force for cost management, but have been able to keep the sensor sales growth at the trajectory that we do have based on these DTC activities. So, we feel very good as we continue to make those transitions and frankly the receptiveness of the physicians as well as the online patients.

I very much appreciate that. And then maybe just quickly on Europe, we obviously called out some headwinds. I know, you mentioned sort of lack of CPT codes is one of them. Is there anything else that you need to sort of work through in terms of barriers to adoption and it does -- it sounds like this will take some time and in particular getting CPT codes if that's a real reimbursement hurdle. Just help us understand, how you're thinking through Europe sort of over the next several years as opposed to just thinking about 2020?

Yes. So, it really does depend on the particular market. As you can imagine, Germany, we specifically spoke to because it is the second largest market obviously for these diabetes technologies and the procedure cost -- codes or the procedure remuneration is one where we have had to do with some of the issues in partnership with Roche. Different markets have different considerations. If it's more socialized, then there really is no impact to the procedure because it's all included or if it's a tender based hospital system, it may be included in those services. So, frankly there's a fair amount of difference depending on the market. Another dynamic that's very important as well as frankly has to do with pricing and different markets of course have different pricing. And I think, one of the things that has hampered Roche's ability to do some of the expansions that they expected to do has to do with the frankly the financial dynamics that exist with a distributed product into a market where the payments may not be as healthy. So, in a place like Austria or Australia, they can be good CGM markets, but it's pretty difficult for two players to be highly successful in lower-priced markets like that. So, I think that financial consideration has certainly been part of the calculus as well.

All right. Thank you so much. Appreciate it.

The next question comes from Marie Thibault of BTIG. Please go ahead.

Hi, thanks for taking the question tonight. I wanted to dig in a little bit on some of the recent coverage wins you've had and then some of the insurers, the big national insurers we're still waiting to hear from. So, especially, could you run me through kind of when you've got wins like Aetna back in 2018, how long it took for some of that uninhibited coverage to come online just so we can kind of sketch out what these late 2019 wins might be on a timeline basis? And then anything you're hearing from some of those insurers where you don't yet have coverage?

Sure. So, timeline; that is a good question. It's not a -- excuse me a switch that is flipped overnight. I would say that it wouldn't be crazy to assume that it could take us three months to work through the entire process. Once we have a decision from a payer to go ahead and get listed in their internal documentation internal approvals as well as to work it all the way through the payer systems. So, as an example Humana or HCSC that came in the November time period, we're probably just coming up to speed now with their ability to provide the coverage. So, we do notice that it takes a little bit of time and we probably still have another month or two in front of us for Cigna. Another one that's very important that we talked about has the dynamic of the local max. So, there are seven administrative contractors essentially seven insurance companies for the medical benefits that cover the United States. And although we have the approval from Medicare to go ahead with the procedure we can't yet bill through for it yet as they are currently holding us to the original category three CPT code designation that was actually granted prior to FDA approval. So, they're headed through a process of converting that and that will likely take even longer than three months to get implemented. But we hope to get those knocked off this year. The next two big remaining payers are of course number one and number two United with a little bit over 40 million covered lives and Anthem with a little bit over 30 million covered lives. So, those are the largest ones we continue to make every effort to work and negotiate with those payers. We currently have about 800 patients that are with United and Anthem that we provided under the Bridge program and we are working as many of those through the Bridge process as well. As we noted, we're very successful with over 90% getting ultimately approved through that process but it is a prior authorization then followed by three appeals. And it can honestly take up six months to get somebody through that entire process. But knock on wood has been very successful when we do it. So, we think that will continue to put pressure on them. We've seen -- we've published a lot of publications so that people understand the clinical benefit. That's one of their questions long-term safety all of that is part of what we present to the medical policy groups to get approval. So, it's not atypical that the largest take the most time and the most work, but we continue to stay on it and we're confident that we'll get there and it's really to be in front of us. In the meantime, we'll continue to support them with Bridge. And show them strong utilization and strong acceptance of the product in their population.

Okay. Thank you for that detailed update. I have a follow-up probably for Nick on balance sheet. You mentioned that you have cash on hand to get through the end of the year Q4 2020. Can you tell us a little bit more about what you're doing on the cost savings front. And then when we might get an update on the potential for a waiver with Solar Capital?

Sure. So, as we mentioned this -- the restructuring that we undertook in Q4 will result in savings of between $20 million and $25 million year-over-year from 2020 to 2019. That's across the OpEx as well as cost of goods sold. We will continue to monitor obviously where the business is and what we need to do from a cash preservation standpoint. And so we'll continue to analyze and evaluate that. We certainly take our liquidity position. Obviously, it's front and center in terms of our focus. With regards to Solar, we have started those conversations, they're what you would expect to have with -- when there is a potential issue with a covenant. We would characterize those conversations as constructive. We certainly look forward to updating everyone. But at this time, I wouldn't put a time line on that. Those can take some time. Going through the investment committee as well as through legal reviews. So again, at this stage, we've begun those conversations and they've been quite constructive. In addition, I think given the coronavirus, there is some impact with folks ability to congregate and get through the issues. So, more to come.

Okay. Understood. Thank you.

Yep.

The next question comes from Alex Nowak of Craig-Hallum Capital Group. Please go ahead.

Hi, great. Good afternoon everyone. Does the OUS guidance assume that Roche doesn't order here in Q1? And I know we only have a couple more weeks left. Shouldn't we already know if they're going to come in and order in this quarter or not?

Yes, our guidance does anticipate that they will not. It is still possible Alex that they could order we're in pretty constant communication with them. But it's our expectation at this point that that will be deferred to later in the year.

Okay. Got it. So you still believe it's going to come in later in the year. Got it. Based on all the commentary here then with Roche them stockpiling the Eversense sensors. It doesn't seem like really either of you want to keep the contract going much longer before the -- by the end of this year. So I mean what are you doing to reach out to other companies here just so we don't have to worry about the international business potentially dropping to zero on January 1, 2021?

Yes, Alex, I wouldn't say that at all. I think it is still an important product for Roche. I think it has been more complex. I think there are a lot of dynamics in that organization. They continue to be very strong in Germany, but the strip and meter market is pretty difficult and their pump market as you know they pulled out of the U.S. So, heavy investments is not something that Roche is able to do right now. But this is an important product for them. They've made a commitment to patients. We've made a commitment to patients. So we'll continue to do what's best for the organization, but I would not like to leave this call with the assumption that this is a dead deal at all. I think their expectations when they first signed the agreement now multiple years ago was that they were going to be in a different place. And we're going to be able to drive this much harder. I think the reality of pricing, the Libre pricing in some markets and some of the other dynamics have impacted that as well. And we need to continue to partner with them and produce the best product that we can to make it as competitive over there as well. So I wouldn't -- I would very much not suggest that we're announcing at all that we or they are casting the relationship aside.

No, understood. And just real quick one more quick question. Johnson & Johnson bought some shares in their innovation fund last year. I think a few people saw that. You mentioned on the call here today that you would like to partner the Flash sensor that's under development with a third-party. That could be a pretty good product competitor versus Libre. Can you give us some more details on just who this partner could be? When would you announce something here? And then just the current development time lines for the Flash product? And just remind us, how long does the Flash sensor last under the skin?

So a couple of questions there Alex. From a partnership perspective, I would suggest that the usual folks that are interested in diabetes or frankly associated disease are the types of folks that would have interest in a long-term product like that. We have certainly heard as people evaluate an implantable sensor that longevity is what certainly matters. And of course, that's why it's key for us to go to 180-days. And I'm sure you saw our announcement that with some of the modifications we've been able to make to the system we are now actively testing our 365-day sensor. So we certainly agree with you that it could be a very, very compelling product, especially for people with type 2 diabetes. And the flexibility that we see in the system as we have patients today that actually wear the transmitter at night and then don't wear it during the daytime. So that would be a great combination, right? A continuous CGM and then something that they could flash during the day if they wanted a spot check in. So our goal continues to be the 365-day sensor, we're stepping into the 180, obviously, to get the experience, to get the feedback, but then we will jump to 365-day and the clinical testing is the first step in that direction.

Okay. Understood. Thank you.

[Operator Instructions] The next question comes from Kyle Rose of Canaccord. Please go ahead.

Great. So just two questions for me. One is, just, can you just walk through the big picture as far as how patient on-boarding works, just specifically the typical time line you're seeing, as far as the patient walking into the doctor's office and requesting a device, versus the time where it actually gets implanted?

Sure, Kyle. There's a couple of avenues that we follow, as they said, if the patient comes in to -- with their interest. So they will have found it online through our DTC activities. If their doctor is a prescriber, it will actually go pretty quick. You'll get the script. We'll do a quick assessment as to whether there is coverage for it or not. If there is coverage, of course, as soon as the doctor is ready to do implanting it can go. They just -- it typically, unless they're one of the very large clinics, they're not keeping a material inventory, but it can certainly be shipped to them overnight, certainly in time to schedule an insertion. If it is one of those that goes through the Bridge program, we actually do that process. We begin the application to their insurance company for their approval, knowing that we're not going to get it on the first one and that's why it's covered in the Bridge, but we do actively work to have it covered by the second sensor and certainly the third. Now in the case when the patient actually finds it and they're not covered by one of the major endocrinology clinics that we've been actively calling on and we are at 500 of those now. You'll do notice that there has been a pretty significant increase in the number of prescribing physicians. So we're up to 1,800 now. Many of those are the result of a patient that goes to their doctor request the product and then he or she will do a script for it, even though they may not be an active prescriber, let's say, this is an internal medicine person or GP and then they will be referenced to a CES, which is the network of providers that we are working with to do the insertion. That unfortunately can take a little bit more time, depending on where they are. We have about 120 and, obviously, we're working to make that number a lot bigger. But once that's mature, we expect it to go further. But if they come into that mechanism, it can take a little bit more time to get the insertions done.

Great. And then, just, you talked about -- I think, I got the numbers right, but you talked about 70% of patients who had some sort of insurance coverage that went into the Bridge program, but you guys bought down the co-pays. Can you talk to us about how you view that number specifically in 2020, relative to the Bridge program? The reason I ask is just from a bigger picture perspective, we've seen Libre and Dexcom make great strides into the pharmacy channel, which has a much lower cost of -- upfront cost for patients. I guess, I'm just trying to understand when you think about the Bridge program, there's the two segments. It's the not covered E&I and then it's the helping with the copay assistance. Do you view that copay assistance aspect of the Bridge program continuing in perpetuity in order to be competitive in the CGM market?

No, we don't. We do anticipate that it's best to invest today and – all said and done, it was about $4.9 million that we invested in 2019. As you noted, 45% were full E&I and another 17% were of this magnitude of assistance. We have anticipated and it is pretty typical in this market that you'll see assistance early in the year and we are seeing as others are some pretty significant increases in the copay amount. So it's likely that as most do that there is some anticipated copay for everybody going forward early in the year but it's not an ongoing thing. We anticipate that we would need to be full time. We are at cost parity. We do see a relatively minor portion maybe 15% or so that go through today as a pharmacy benefit. But remember the primary focus for us and we've made good action on. This is actually a medical benefit for many folks and those actually have lower deductibles in many cases than durable medical equipment does. So there are puts and takes in both directions but I would anticipate some low level of it like everybody uses. But not a major initiative for price parity.

And then – okay, that's very helpful. And then just one last question for me. It sounds like we should be modeling for no reorders from Roche in the Q1. So no revenues in the Q1. Does your guidance assume that they're going to order into Q2? I mean, it sounds like they were starting to build up inventory in Q3, Q4. Q4 is obviously a big number. Just trying to understand, should we be really back-end weighting the majority of that OUS number to the Q3, Q4 of 2020 or should we expect to see some level of revenues in the Q2?

Yes. We've always back-ended it with them in the way that they order. It's always been a big Q4 and I think we've certainly seen that again. We have taken the overall down. And we do anticipate that they will order some but we still are estimating that the majority of it will come in in the fourth quarter.

Okay. Thank you.

This concludes our question-and-answer session. I would like to turn the conference back over to Tim Goodnow, CEO for any closing remarks.

Well great. Thank you very much and we appreciate everybody's time this afternoon, especially in these complicated times that we're currently living. I would like to again appreciate everybody's hard work and attention here. We know that this has been trying times with the virus out there and it's also been very active for us. So I appreciate staying here late in the evening and good luck. We look forward to speaking with everybody at the next quarter. Thank you.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.