Esperion Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference call over to Ben Church, Investor Relations and Corporate Communications at Asperion. Please go ahead, sir.

Thank you, operator. Good afternoon and welcome to Asperion's fourth quarter and full year of 2020 financial results and company update conference call. I'm Ben Church, and I'm responsible for investor relations and corporate communications here at Aspirion. With me on today's call are Tim Mayleben, President and Chief Executive Officer, Sheldon Koenig, Chief Operating Officer, and Rick Bartram, Chief Financial Officer. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, February 23rd 2021 we undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call in webcast as a reminder this conference call and webcast are being recorded and archived we issued a press release this afternoon detailing the content of today's call a copy can be found at www.esperian.com within the investors and media section we will begin with prepared comments and then open the call for your questions Following today's call, the team will be available for follow-up questions. Please email investorrelations at aspirion.com to schedule 15 minutes to speak with our team. I'd now like to turn the call over to our president and CEO, Tim Mayleben. Tim?

Thank you, Ben, and good afternoon, everyone. We appreciate you joining us today as we update you on Aspirion and the significant opportunity that we believe still lies ahead. Since we announced preliminary financial results several weeks ago, we'll keep our prepared remarks brief and get into Q&A. Now, for many, 2020 will be remembered as the year everything changed. While the world changed around us in obvious ways, Aspirion changed fundamentally as a company. We received our first marketing approvals for Nexla Tall, Bempadoc Acid, and Nexla Zet, the first ever non-statin fixed-dose combination tablets. of benpidoic acid and azetamide, moving us from an R&D company to an R&D and commercial organization and global partner. This was an accomplishment more than 10 years in the making and one that most companies never realized our team did. We also secured additional marketing approvals in Europe, the UK, and Switzerland under the brand names Nelendo and Newstendi. We worked with our EU commercial partner Daiichi Sankyo Europe to launch in Germany in 2004, while earlier announcing a strategic collaboration with Otsuka Pharmaceutical to develop and commercialize our medicines in Japan. All of this as we and the rest of the world battled against the uneven impacts of COVID-19 and the vast majority of people stayed safely at home. Following their approvals by FDA, we launched our medicines in the U.S. in the second quarter of 2020, and while we haven't yet achieved the commercial potential for our medicines, we're confident the long-term opportunity remains intact. Throughout 2020, far fewer patients ventured to their healthcare providers in avoidance of the virus, resulting in fewer written statin prescriptions and non-statin prescriptions for lowering bad cholesterol than the year before. This was the first time in history that statin prescriptions declined year over year. But despite this, 21,000 patients in the U.S. filled Nexlatol and Nexlazet prescriptions in 2020. We continue to hear resoundingly positive feedback about how Nexlatol and Nexlazet are working to lower patients' LDL cholesterol levels in combination with diet and maximally tolerated statins, which is an important metric for our future success. As the lipid management company, we are constantly seeking to better understand patients' experiences, especially those whose needs aren't being met by current treatment options. We work to discover, develop, and commercialize innovative medicines in combinations with established medicines that are easy to get, easy to take, and easy to have. We have an enviable track record in delivering upon our development commitments with a world-class R&D team. The team is now fully focused on successfully completing our landmark, clear cardiovascular outcomes trial, what we call a CVOT, that will determine the ability of benpidoic acid to reduce cardiovascular events such as heart attacks and strokes. We've invested in the CVOT because there is tremendous unmet need for additional drugs that reduce the risk of cardiovascular events, the number one leading cause of death in the world. We believe patients around the world deserve better than the status quo. We aim to change the therapeutic landscape, a landscape that has resulted in an overall underinvestment in the development of new cholesterol-lowering therapies for cardiovascular disease. In particular, There is a significant need among people who can't reach their LDL cholesterol goals with maximally tolerated statins who, as a result, are at high cardiovascular risk and in need of non-statin options. This statin intolerant patient population is a group you have heard us speak about many times in the past. There are more than 35 million patients considered statin intolerant in the US, Japan, and the EU. Statin intolerance impacts up to 20% of individuals who have been treated with the statin. Literally tens of millions of adults need to lower their levels of bad cholesterol beyond diet and maximally tolerated statins. And the vast majority need convenient, non-statin, once daily pills that are affordable. Clear Outcomes is a pioneering event-driven trial, the first of its kind, focusing on statin-intolerant patients. With over 14,000 patients enrolled, it is powered for success and is optimally designed to demonstrate the full potential of bumpidoic acid, impressive LDL cholesterol lowering for patients that can't or won't take statins, statin-like levels of HSCRP reduction in a non-statin oral medicine, and the potential for showing additional positive glycemic effects. Despite the pandemic, the CVOT remains on track. In fact, we collected 50% of the major adverse cardiac events, the primary endpoints, during the third quarter of 2020 and remain on target for the second half of next year. Positive results from the CVOT will have the potential to once again prove our leadership and our willingness to take on the hard challenges for patient groups that have been underserved. We're also working with other purpose-driven companies to deliver upon our promise around the world. We've entered into collaborations with Daiichi Senkyo in Europe and Otsuka in Japan, both of which have extensive experience in the cardiovascular field. In Germany alone, 4,000 patients were on our medicines within the first two months of the launch by DSC. For Japan, Otsuka plans to initiate a phase two study in Q1, in fact, this quarter. We continue to work through the last major piece of the global benpidoic acid network, completing a rest-of-world partnership that will further increase the future opportunities of our medicines to reach patients around the world. Perhaps most importantly, even after completing the rest-of-world partnership, Aspirion will still own exclusive rights to almost 70% of the global benpanoic acid franchise value. In closing, 2020 will be remembered as the year everything changed, including leaps forward for patients struggling with high levels of bad cholesterol. We're grateful to the patients and healthcare providers who placed their trust in our company and our medicines. We thank our shareholders for your ongoing support of Aspirion. And we take pride in our accomplishments and look forward to the post-pandemic world with great optimism. Next, Sheldon, who recently joined us as our Chief Operating Officer, will share how he is applying his extensive experience in cardiovascular to bring us to a leadership position with our medicines as the pandemic recedes. Then, Rick Bartram, our CFO, will highlight how we are reinforcing the company's ability to grow with diversified revenue streams, conservative expense management, especially during what remains of the pandemic, and our focus on maintaining a strong cash position. With that, I'll turn it to Sheldon. Sheldon?

Thanks, Tim, and good afternoon, everyone. For all of you, I haven't had the pleasure to meet yet. I'd like to give a brief highlight of my background and what brought me to Experian. Over the last few decades, I've worked in various commercial operations and marketing roles across the cardiovascular space. I spent 27 years at Merck obtaining extensive U.S. and global experience in sales, marketing, and market access within the CV franchise until I first took lead of the global cardiovascular franchise and worked directly on Zetia and Biturans. From there, I moved to Sanofi to run their global cardiovascular business, including Pralulent, and managing the relationship with Regeneron. Most recently, I served as Chief Commercial Officer of Portola, overseeing the U.S. organization and building from the ground up the global business recognized today. In short, I've been in the cardiovascular space for a very long time and have directly worked with all of the LDL-C lowering solutions the market has to offer. I plan to apply my learnings from these past launches to really accelerate the commercial adoption of Nexlatal and Nexlazet in the U.S. and ensure the full potential of our medicine is realized for patients. Within the U.S., there's a staggering estimated 18 million people that need additional support managing their cholesterol, either due to tolerability concerns or because current treatment options are not enough for patients to reach their LDL cholesterol-lowering goals. Bepididoic acid and its combination with azetamide, now marketed as Nexatol and Nexazet here in the U.S., are the solutions these patients need. They easily fill the gap between diet, maximally tolerated statins, and injectable PCFK9 inhibitors as once-daily oral non-statin medicines. I joined Aspirion because I wanted to be part of the solution, delivering millions of patients the necessary therapy to battle elevated LDL-C biomarker that is known to lead to cardiovascular disease, the world's number one killer, accountable for one out of every three deaths, and what's worse, it is asymptomatic, a silent killer. On a more personal note, after my battle with cancer, a leading KOL made the comment in the meeting once that I always worried about my cancer returning. He said, be more worried about your risk of dying from CV disease than cancer. This was the wake-up call I apparently needed to visit a cardiologist. As I soon learned, I was at high risk with a baseline LDL-C level of 140 milligrams per deciliter and a family history. So at a time when people are foregoing their usual medical checkups and active healthy lifestyles as a result of this pandemic, managing LDL-C is more important now than ever. It is clear to me Nexlatal and Nexlovet did not get the standard launch opportunity afforded to all other LDL-T medicines before us. However, we do have an opportunity to make an accelerated impact as we all emerge from this pandemic. Although we cannot give you a specific date, week, or month, we are certain with the pandemic receding and an easing environment, patients will return to physician's offices in droves. It is not a matter of if, but when. In the interim, Aspirion is implementing a number of initiatives, which I will discuss in a moment, to ensure we are the best position to capture patients as they return to physician's offices in the wake of the pandemic, but also for long-term sustainable growth of the franchise. Since my arrival to Aspirion, I've identified three areas that with refined commercial strategy will garner increased awareness and momentum in the adoption of our medicines. I've initiated a number of internal organizational changes to better align customer-facing groups for increased collaboration and synergies across the business. One such move is better integrating the medical science liaisons to amplify our medical and scientific communications efforts. Based on my experience, there was significant untapped potential with the MSLs that we'll look to leverage. MSLs are instrumental in building a strong scientific platform while also developing relationships with KOLs who influence broader adoption of medicines through educating our respective healthcare professional communities of the large gap in LDL-C lowering medicine and need for additional therapies. Driving awareness of Nexplatel and Nexclavet and the benefits they can provide patients is the first task on my to-do list. Physician attention has largely been diverted during this pandemic. But now, as this hyper-focus abates, medical education of new medicines will once again be prioritized. As Tim touched on earlier, the CLEAR outcomes trial will be a monumental for the Nexitol franchise in this manner, should we be granted the indication expansion. But until that reads out, we are looking to equip our commercial team with a real-world evidence study that depicts the current treatment paradigm and exposes the shortcomings of treatment, even with the currently marketed LDL-C lowering therapies that exist today. Not only will this study corroborate the Aspirion mission, but it will also deliver our products directly into the hands of hundreds of physicians and allow them to experience firsthand the power of our innovative medicines. We are confident, given the continued overwhelmingly positive feedback around our medicines and their demonstrated ability, that facilitating physician use of our products in this way will translate into longer-term prescription growth. But not only are our products effective, they are cost-efficient for patients. We believe this point has been lost on physicians and payers alike. We intend to leverage our new health economics and outcomes research specialist to create and support our value proposition. We'll look to target health economics publications to complement our clinical development work and further guide decision makers regarding patient access to our medicine. It is not enough to just ensure physicians know of our medicines. but it is critical that healthcare providers understand the appropriate patient population and where along the treatment paradigm our products fit. This was the motivation behind our virtual peer-to-peer educational meetings with HCPs that we continue to host to this day. The team and I are working to create a virtuous and reinforcing cycle, enhance product positioning with increased messaging precision that will drive a more favorable physician experience with a greater number of patients' results, which will in turn encourage even broader market acceptance of our medicines and use by HCPs. The last area I'll focus on is managed care. Whereas our managed care coverage will continue to build, especially on Medicare Part D, since we have essentially all relevant commercial covered lives, the vast majority of preferred grant years with the lowest patient out-of-court costs We are taking action to encourage improvements on the onboarding and pull through of our managed care coverage. We are integrating a reimbursement specialty into our market access strategy to bridge the gap between contract completion and implementation. What this means is we are building in the responsibilities of our account managers to hand hold each contract through to full implementation. We believe this addition will cultivate and hasten the last bit of coverage to come online. especially on the Medicare Part D side, leading to improved access to our medicine and higher potential for prescription volumes. Cumulatively, these initiatives requiring little to no additional cost, which we are implementing now and will take some time to demonstrate throughout, will pay dividends as we emerge from this constrained marketing environment. I am confident in the long-term demand for oral, once-daily, non-fattened medicines, such as Nexlatol and Nexlovet. and this team's ability to execute. I would not have joined Experian if I felt differently. I look forward to providing you with additional updates on the effectiveness of our efforts and advancement of our commercial progress in the months to come. With that, I'll now turn the call over to Rick for remarks on our financial performance.

Thanks, Sheldon. Today, I'd like to spend my time addressing how COVID's impact on our launch and our U.S. product revenues required an optimization of the Aspirion cost structure and what steps we have taken in order to create a more sustainable business model for the future. By now, I'm sure you're all aware how COVID interrupted our commercial plans and disrupted the conventional healthcare model associated with normal health management practices. For example, regular physician office visits, lab tests, and prescription refills Seemingly overnight, the commercial environment we were depending on for a successful U.S. launch stopped in its tracks. For all of our hard-fought efforts and adaptations on the commercial side of the business, we generated $13 million in U.S. product revenue for the full year 2020 and total revenue of $227.5 million in with significant collaboration revenues of roughly $215 million. On expenses, after building out our commercial function and the necessary processes and systems to support our transformation from a late stage R&D company into a commercial and R&D organization, we initiated an evaluation to identify and implement several opportunities for cost saving. The first being inventory. As a result of COVID negatively impacting demand and our wholesalers more cautiously managing inventories, we adjusted our budgeted production plans last year, resulting in associated savings. As our original marketing budget was based on assumptions of a normal market conditions and pre-COVID revenue ramp, we subsequently focused on right-sizing these activities for internal ROI threshold and prioritizing initiatives with high return on investment. As Sheldon explained earlier, there are a number of initiatives to support the U.S. commercialization of Next Let's All and Next Lizette that come with little to no additional cost. The team also had to make difficult decisions throughout the year on our commercial footprint, customer-facing teams, as well as other non-sales functions that supported the launch. Overall, company workforce was adjusted for the near-term growth potential and the current environment that we're in. This includes the field force where we conducted standard performance management reviews and also modified the sales geographies to adapt for COVID hotspots and shelter-in-place notices. Our prudent expense management activities culminated in full year 2020 operating expenses of approximately $350 million, falling well below the original February 2020 OPEX guidance range of $400 to $420 million. Furthermore, last month, we guided total operating expenses for the full year 2021 of $320 million to $340 million, inclusive of $30 million of non-cash stock compensation expense. Since the original full-year 2020 OPEX guidance only included nine months of commercial expense, this decline represents an expected annualized cost savings of approximately 25 percent. To review, R&D expense for 2021 is expected to be between $120 to $130 million, slightly down from last year, but generally this reflects the steady state costs associated with our fully enrolled CBOT study. Our anticipated full year 2021 SG&A expense is in the range of $200 to $210 million. We ended 2020 with approximately $305 million in cash on hand. In addition, we remain confident we will receive an additional cash upfront payment from a rest of world deal. Further, our existing revenue-based funding agreement with Oberlin Capital will provide us an additional $50 million this year. Both will bring additional near-term cash to our balance sheet. Finally, I would like to remind you all that Aspirion has over a billion dollars in future milestone payments from our existing XUS collaborations. These will continue to feed our balance sheet in the months and years ahead as our partners continue to execute or should we decide to monetize these. Overall, our cost management initiatives are focused on the preservation of our first-in-class CBOT study and revenue generating initiatives with high return on investment. We are now a more nimble organization with an efficient cost structure that allows us to reinvest when the time is right and as the external environment approves. Going forward, we will continue to assess the cash spend against our growth potential and ensure the organization is adequately resourced to advance the business and create greater shareholder value. With that, I will turn it back to Tim for closing remarks.

Thank you, Rick. I would just like to close with this. The COVID-19 pandemic was an unforeseeable obstacle that we all faced throughout 2020 and to this day. However, COVID-19 is a short-term headwind, and the negative impacts of COVID-19 won't be with us forever. Both Aspirion and our partners remain very confident in the long-term potential of our medicines. We think the future is bright for Aspirion and will continue to fight through the challenges to get our therapies into the hands of patients that need them. We look forward to the coming months as we prepare for a return to normal and the ability to really accelerate the growth for our medicines. So I want to thank you for joining today's call. Operator, please poll for questions.

Thank you. Ladies and gentlemen, to ask a question on the phone line, please press the star, then the one key on your touchtone telephone. To remove yourself from the queue, press the pound key. Please stand by while we compile the Q&A roster. And our first question coming from the line of Martin Oster with Credit Suisse. Your line is now open.

Hi, everyone. This is Mark Gahn from Marty. Thanks for taking my questions. So I guess my first question is I saw that you had mentioned that there are 4,000 patients in Germany on benpidoic acid. And so would you be able to help put that in perspective relative to the pace of the launch in the U.S.? And I guess were any of these 4,000 patients in expanded access programs? And, yeah, any additional details you could provide?

Yeah, sure. Mark, this is Tim. So, you know, we provided the number. It is, I think, you know, by all accounts, an impressive number. It really cements the decision that we made almost two years ago to partner with Daiichi Sankyo. As you'll remember, we had said at that time that they have an incredibly successful cardiovascular commercial organization numbering more than 1,000 people across Europe. And they had been phenomenally successful with the launch of Lixiana several years ago. So we certainly expected, they expected to perform extraordinarily well. Our understanding is they're running a very similar playbook, if you will, to to the launch of Lixiana and I think these early numbers, early patient numbers indicate the strength of their commercial organization. I think what we can say is that these are not, these are true commercial patients, paying patients, not in any way patient assistance programs. that we're aware of. So I think it's good numbers, but like I said, I think it's certainly an early indication, and it's early, but an early indication of the capabilities of the organization in Europe. Dave, you say thank you.

Yeah, I agree. It'll definitely be worth keeping track of. And then I guess just my second question is, I'm just curious to get an update on how the rest of the world partnership discussions have been going and if there's any update in terms of how we should be thinking about potential timing or size of that potential agreement. Thank you.

Yeah, sure, Mark. So, good question. So, as we said in our prepared remarks, that is tracking for completion this quarter. We feel good about that. As I think we said earlier in the year and late last year, obviously our goal remains to optimize the value ascribed to the rest of the world. And so, again, we're tracking toward that timing.

Okay, great. Thanks again for taking my question. You bet.

And our next question coming from the line-up, Tom Schrader with BTIG. Your line is open.

Hey, guys. This is Julian on for Tom. Congrats on the quarter, and thank you for taking my questions. Regarding the U.S. launch, I'm wondering if you could comment on script growth among lipid specialists versus GPs, and also maybe any prevailing geographic trends such as regional center versus community uptake. And then, Rick, U.S. revenue for 4Q implies an improving gross net. So I'm wondering if we should expect this trend to continue, and if so, for approximately how long? And maybe can you remind us what the factors at play are here?

Hey, thanks. Sheldon, can I ask you to take the first questions and then tip it to Rick to respond to the others?

Yes, will do. Thank you so much. And thanks for the question. So as it relates to prescribing, what we're seeing is that in overall prescribing, you may recall that J.P. Morgan, we showed where the HMG statins had decreased. We still see a decrease of statin use by about 9% currently, but we are seeing this slowly rise and come back. As it relates to prescribers, essentially cardiologists versus PCPs, I think it's more so the contribution by both. Obviously, there's more PCPs than there are cardiologists, so you do see slightly more prescriptions from primary care physicians and growing, and you also see that with cardiologists and growing. There really isn't any type of geographic disparity. I think if the question is a bit deeper as it relates to are some states doing a better job of rolling out the COVID vaccine, which I think we have all stated has really slowed patients and physicians even coming back for treatment. We do know, you know, just from watching the news that some states are slower than others, but we're not seeing any disparity from a geography perspective as it relates to some patients coming back slower, some patients coming back Now, we have not done intense research in that. That's just, you know, overall in looking at some of the data that we receive on a weekly basis.

Thanks, Sheldon. Rick?

Yeah, sure. Thanks, Julian. So, as you know, you know, we've been pretty consistent that we don't disclose our gross to net really for competitive purposes. You know, as we think about, you know, gross to net's, We're pleased with where our growth sonnets are currently at, and as Sheldon mentioned in prepared remarks, you know, we're going to have continued plans coming online, particularly in the Part D space. But overall, you know, pleased where we're at, and obviously as we proceed ahead and have increases in volumes, you know, things will start to level out as all the plans come online.

Okay, great. Very helpful. Thank you. Thanks, Jillian.

Now our next question coming from the line of Michael Yee with Jeffrey Phelan is open.

Hey, Tim. Hey, Rick. Two questions on our side. Do you feel like the patient volumes are picking up in the January, February timeframe? Maybe just talk about what you're seeing in the environment. We hear different things from different types of doctors and different types of medicines. Maybe just make a comment about that. And as that relates to your confidence, if COVID is an issue, about sequential acceleration, do you feel confident you should see a pickup in sequential growth? I think you did 3.3 going to 8 million, which was a good number in the fourth quarter. So do you see that kind of ramp as COVID alleviates? So talk about those two things, and I have a follow-up.

Yes. Okay, great. Sheldon, can I tip those to you?

Yes, will do. And thank you, Michael, for your question. Just as it relates to patients coming back, physicians coming back, we don't really have any quantitative data that we capture that we can speak to that. You know, we essentially get information from the field. And I think, you know, what we're seeing is it's a slow trickle back. January was still the deadliest month as related to COVID. And as you know, we just went over the 500,000 death mark, unfortunately. But 2020 has taught us anything. It's really to be flexible and really monitor the situation. We're not necessarily giving a specific timeframe of when we'll return to normal, but I think we have all the initiatives in place that that we're currently working on that once we do return to a normal and more patients are vaccinated that, you know, we expect that, you know, our growth will accelerate. But what we're waiting to see is how quickly this vaccination rollout will occur. And with that, we'll see that more patients will return to the office, as well as offices actually opening themselves up for them to see patients.

But I guess in general, if patient volumes are steady or getting better, your commercial work should accelerate sequential growth just because you should have people staying on and each quarter or each month you should have more people coming on. So do you think that acceleration should be the right way to think about it each quarter?

As we move forward with each quarter and as more patients are, I think, you know, vaccinated, more offices, physicians, you know, they themselves are vaccinated, yes. I mean, our hope is that patients will resume going to offices. You know, one thing that we've learned is that patients were not truly getting their physicals. Telehealth doesn't really work in cardiovascular medicine. We have research that shows that, and therefore patients weren't even getting their lipid panels. So I think by default, as you know, based upon what we're doing to your point from a marketing perspective and the initiatives that we're putting in place as patients continue to return to physician's offices, we would hope that based upon our initiatives that we will see acceleration in our growth. It's just a matter of timing of as relates to vaccinations and how quickly we all emerge you know, out of this pandemic. I mean, we all see that number of cases are declining, et cetera. So now it's just a matter of, you know, vaccinations and people feeling more comfortable going to their physician.

Yeah, that's good for 21. And then last question relates to your starter packs. You had a big number there in the slide deck. Can you just remind us how starter packs work? Do people stay on them for a while? Do they transition to commercial? Maybe just any comments and remind me how those work. Thanks. Yeah, Sheldon.

Thank you.

Yeah. So, so starter packs are essentially, um, it's really samples. It's distribution of samples and our samples are distributed, um, to essentially all physicians in our target audience. Um, we have distributed quite a bit of samples and allows the physician to try the patient, uh, on the drug. And it's typically a, um, seven day sample configuration. So the patient can take the drug for seven days and then from there, They're usually given the sample box with the prescription, and then they go ahead and fill the prescription at the local pharmacy. Okay.

Thank you, Josh. Sure. Thanks again, Mike.

And our next question coming from the line of Jeff Misham with Bank of America, Yolanda Sullivan.

Hey, guys. It's Olivia Brera. Thanks for the questions. Kim, I wanted to ask you on BD going forward, is there an appetite to do deals that maybe are more mid-stage development and capable of driving growth within the next few years? Or, you know, at this point, is it mainly focusing on earlier stage programs? And then as a follow-up to that, is external VD becoming more of a priority at this point, whether that's through partnerships or other strategies? I guess I'm trying to get a better sense for, you know, whether we should expect a more aggressive approach for pipeline diversification going forward. Thanks very much.

Thanks. Thanks, Olivia. I will have a very brief answer for you, which is this organization, as you heard Rick say, is 100% focused on two things. One, the commercial success of Nexatol and Nexazet. And two, the cardiovascular outcome study, the clear outcome study and the success of that study, which I think, as you heard us say, is progressing rapidly. extraordinarily well, especially in the broader COVID environment. So nothing more to say at this point on business development. Really, like I said, this organization is entirely focused on those two drivers.

And our next question coming from the line of Chad Messer with Neham & Company. The line is open.

Great. Thanks. Good evening. Thanks for taking my question, and congrats on some solid progress. Just taking a look at your 2021 OPEX guidance, and it's great to run a tight ship, especially with uncertainty in the environment, just wondering with that, you know, pretty tight range and, you know, granted a very favorable comp to 2020, do you think you have enough optionality to pursue things in a more favorable environment? You know, if, you know, obviously we all have a baseline and an upside and a downside case. It seems like you've got yourself in a, in a narrow window, just wondering on, you know, whether you can comment on whether you feel you could be aggressive enough if the situation warranted.

Sheldon, do you want to comment? Thanks, Chad.

Sure, yeah. So I think, you know, based upon, you know, where we are today and the initiatives that we are putting in place, I think that, you know, we are equipped to be able to do what we need to do, I mentioned in the prepared comments some of the organizational changes that we've made, which will give, for lack of better words, greater line of sight of not only our commercial team, but also on our medical affairs side with our medical science liaisons and the scientific platform that we will be building. These are not things that necessarily cost money. These are things that just take thinking time. And in doing that and essentially really being very purposeful in our strategy and the position of our products, I think we're well-equipped to move forward and, again, to accelerate growth in 2021.

All right. Well, here's to hoping for high-quality problems. Thank you.

Thanks, man. Thanks, Jeff.

And our next question coming from the line of Josephson with Cohen. Your line is open.

Hi there. Thank you for taking my questions. Sheldon, you did emphasize that part of going forward is going to be educating physicians on sort of the appropriate patient population to use the assets in and kind of where along the treatment paradigm, next to tall and excess, that will fit. Is there a specific patient population thus far that you are surprised isn't coming on faster, or is there a specific message that you think is kind of getting lost, or is it mostly just COVID kind of clouding interactions? And then second, in terms of sort of real-world compliance, once patients do come on, do they tend to come back and get refills and stay on product? Thanks.

Yeah.

Great.

So as we – oh, Tim, because – yeah. Yeah. So, um, apologize for that. So as it relates to, um, messaging and patients, et cetera, we actually have some work ongoing right now, which is specifically looking at patient segmentation. I think one of the things that we have, uh, to your point that was a bit cloudy with COVID, um, due to the fact that the company launched during COVID that, you know, awareness, um, was somewhat lost. Um, And this goes back to why we really need to reestablish our scientific platform and our scientific issues to define the unmet need and also set up the appropriate patient population and the messages that go along with that. And as we go into, uh, the next few months and so forth, we'll definitely, um, update you as it, as it relates to that. Your, your second question was, if you could just give me your repeat, your, your second question.

This is on real-world compliance and refill.

Yes, on refill. So on real-world compliance, what we've seen, we've actually looked at refills, and we've actually benchmarked ourselves to other products that are commonly used, and we see the majority of patients are refilling their prescriptions, which is a good sign.

Great. Thank you very much. Sure. Thanks, Joseph.

Our next question coming from the line of Derek Archul with Steeple. Your line is open. All right. His line is coming in with technical issues. Our next question coming from the line of Paul Chao with Goldman Sachs. Your line is open.

Hi, everyone. Thank you for taking our questions. This is Charlie on for Paul. Two quick ones for me, if that's okay. I was just wondering, we're wondering if in 2021, are there plans for sustaining patient co-pay assistance throughout the year as the launch is hoping to improve throughout the year? And then my second question is whether or not there was any influence regarding inventory in this quarter's numbers. Thank you so much for taking our questions.

Yep, thank you. Rick, can I tip that to you?

Yeah, so on those, you know, the copay program is something that's important to us. We're obviously going to continue to evaluate that, but that is intact for 21. And, you know, short answer, no impact on inventory in terms of revenue.

Great. Thank you so much.

I'm sure I know for the questions at this time. This concludes this conference call. Thank you all for participating. You may all disconnect.

Thank you so much. Thank you.