Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Esperion Therapeutics (ESPR 5.08%)
Q4 2021 Earnings Call
Feb 22, 2022, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in listen-only mode. Following the presentation, there'll be a question and answer session. Please be advised that today's conference call may be recorded.

I would now like to turn the conference over to Ben Church, investor relations, and corporate communications at Esperion. Please go ahead, sir.

Ben Church -- Head of Corporate Communications and Investor Relations

Thank you, operator, good morning and welcome to Esperion fourth quarter and full year 2021 financial results and company update conference call. I'm Ben Church, and I'm responsible for investor relations and corporate communications here at Esperion. 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 the 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 in our 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 22nd, 2022. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast.

10 stocks we like better than Esperion Therapeutics
When our award-winning analyst team has a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.* 

They just revealed what they believe are the ten best stocks for investors to buy right now... and Esperion Therapeutics wasn't one of them! That's right -- they think these 10 stocks are even better buys.

See the 10 stocks

*Stock Advisor returns as of January 20, 2022

As a reminder, this conference call and webcast are being recorded and archived. We issued a press release this morning detailing the content of today's call. A copy can be found at www.esperion.com within the investors and media section. We will begin prepared comments and then open the call for your question.

On today's call, the team will be available for follow-up questions. Please email corporate team at esperion.com to schedule time to speak with the team. With us today are Sheldon Koenig, president, and CEO; Rick Bartram, CFO; Dr. Jo Anne Foody, our chief medical officer; Eric Warren, our head of sales and marketing; and Betty Jean Swartz, senior VP of market access, HEOR, and policy.

I'll now turn the call over to Sheldon for prepared remarks. Sheldon.

Sheldon Koenig -- President and Chief Executive Officer

Thanks, Ben. And good morning, everyone. Over this past year, the team at Esperion worked diligently to rebuild a strong foundation and set of course, for future success. As a result, we entered 2022 in a position of strength and reenergized for the opportunity that lies ahead.

Our transformational plan announced back in October, we have optimized our business to better align with the current healthcare environment. An extensive review of the organization and return on investment drove our decision to establish a new hybrid commercial model, through which we are able to reduce our commercial footprint down to a core sales team of 80 territories, while generating $80 million in annualized cost savings. Maintaining our ability to drive consistent growth of our medicine, and the flexibility to scale up in the future. During this transitional period, sequential demand of our medicines grew 9% in the fourth quarter, with US net product revenue of $12.2 million, up 12% in the same period, and over 200% for full year 2021.

These strong results were also the culmination of the enhanced product positioning, and refined patient support programs we initiated in 2021. Further, in the January of this year, we deployed a contract sales organization on a trial basis to drive awareness among our targeted positions within the wide space between 80 core territory. The CSO can also be easily scaled up or down dependent on productivity, and is something we view as a cost-effective growth resource. Overall, the results of the fourth quarter give us increased confidence, that we'll continue to deliver consistent growth, leading up to the top-line readout of the CLEAR Outcomes trial in the first quarter of 2023.

With the additional $209 million in net proceeds from our December financing, our cash runway now extends beyond this pivotal milestone. With $309 million in cash as of December 31st, Esperion is well-positioned to execute on its strategy in these current market conditions. More importantly, our unprecedented CLEAR Outcomes trial continues to progress unencumbered. The trial reached 90% of its required major adverse cardiac events this February, indicating CLEAR is tracking in line to slightly ahead of expectations.

With a top line readout anticipated in Q1 2023, we are now less than one year away from a major inflection point in our growth trajectory. As such, in addition to executing on our plan to drive commercial growth of NEXLETOL and NEXLIZET, a major focus of Esperion for 2022 is successfully closing out the pivotal CLEAR Outcomes trial. As a reminder, CLEAR Outcomes is a 14,000 patient randomized outcomes trial. One of the largest outcomes trials of non-statin therapy.

Evaluating bempedoic acid ability to reduce incidence of adverse cardiovascular events in a unique patient population that is unable to adequately address their CDRF with the current standard of care. The trial design was developed in partnership with regulators and is headed by the world-renowned trial of Dr. Steven Nissen. This, along with the size, scale, and scope of the study, gives us great confidence.

A [inaudible], not only has the potential to expand our current label indication, but also to be practice changing for physician, and life changing for millions of patients around the world. During 2021, Daiichi Sankyo accelerated its commercial launch in Germany, while also expanding into the UK. and Austria, amassing over 45,000 patients on therapy through December. Even more so, we expanded our partnership with Daiichi to bring bempedoic acid and its combination with ezetimibe to the APAC region.

Esperion continues to evaluate any and all opportunities such as this, to accelerate the distribution of our medicines to patients not being treated to LDL-C goal. Otsuka, our partner in Japan, continues to progress along its clinical pathway. Its Phase II study was initiated in Q1 2021 and was fully enrolled by end of December. Well, 2022 will be an important year for Esperion as we prepare for several milestones.

It also is critical for the millions of people living with heart disease and those recovering from COVID-19. In 2022, the world hopes to finally see a retreat of the COVID-19 pandemic. However, this devastating disease has taken its toll on global health, and longer-term, and insidious ways. Already, the number one killer worldwide, cardiovascular disease was worsened by the COVID-19 pandemic, driving an acceleration of cardiac events, and increasing the number of patients at risk.

According to a recent study published by Nature Medicine, COVID-19 survivors are left with a 63% higher risk for heart attack and a 52% higher risk of stroke. Study researchers found COVID is an equal opportunity offender, increasing the risk of cardiovascular problems for all people, no matter age, gender, or health status. The time is now more than ever for increased efforts to protect our heart health, and as such, we expect a renewed focus from physicians on cardiovascular health, and a heightened sense of urgency in getting patients to go. NEXLETOL and NEXLIZET are commercially available to get, to provide the necessary benefits, to struggling indicated patients immediately.

As a leading biotech in cardiovascular disease prevention, our focus will remain steadfast and diligently completing the CLEAR Outcomes trial. Educating doctors about implications, and continuing to progress our pipeline, that includes an oral PCSK9 inhibitor, and an ACL inhibitor platform in order to benefit more patients worldwide. I look forward to updating you on our continued progress throughout the year, and demonstrating our commitment to innovation for patients. And now, I'll pass it through over to Rick, for additional commentary on our quarterly and annual results report.

Rick Bartram -- Chief Financial Officer

Thanks, Sheldon. Earlier today, we issued a press release containing our financial results for the fourth quarter and full year, which is available on our investor website. US net product revenue was $12.2 million for the fourth quarter, up 12% from the third quarter, and $40 million for the full year, up over 200% compared to the prior year. Royalty revenue for the fourth quarter was approximately $800,000 and $3.6 million for the full year 2021.

In the fourth quarter, net price for our medicines continued to improve, marginally yielding the benefits from the changes to the co-pay card program we made during the year. We expect incremental improvements to the net price of our medicines over time as plans fully implement coverage and volumes scale up with significant opportunity to fully further improve our net price post-CLEAR Outcomes results. I would refer you to the press release for additional details on our revenue performance as compared to prior periods. But overall, we're pleased with the growth of our brands over the last quarter and year, despite the disruption in our business that occurred during 2021.

Turning to expenses, R&D expense for the fourth quarter totaled approximately $28 million slightly up from the $25 million during the third quarter due to timing of CVOT related expenses. Full year 2021 R&D expense totaled $106 million, representing a 28%  decrease year over year. Selling, general, and administrative expense for the fourth quarter was approximately $38 million, representing a 2% decrease from the third quarter. An assumed expense for the full year.

2021 was $185 million, down seven percent year over year. We continue to anticipate that full year 2022 R&D expenses to be between $100 to $110 million, and SG&A expenses to be between $120 $130 million. These estimates are inclusive of approximately $25 million of non-cash stock-based compensation expense expected to be incurred during this year. Our cash balance as of December 31st was approximately $309 million, inclusive of the proceeds from the December equity offering.

We are now well-capitalized and anticipate that our cash runway expense extends through the anticipated completion and read-out of the CLEAR Outcomes trial, and continues to fund continuing operations for the foreseeable future following those results. Historically, we've demonstrated our commitment to manage our cash expense, and strengthen our financial position to ensure the completion of our clear outcomes trial, and the continued advancement of the NEXLETOL and NEXLIZET commercial launch. I'm proud of what our team has been able to accomplish on this front during 2021. With that, I'll turn it back over to Sheldon for closing remarks.

Sheldon Koenig -- President and Chief Executive Officer

Thank you, Rick. I'll close with this, a reminder that cardiovascular disease, while already the number one killer across the world, has been worsened by the pandemic. and requires immediate action. Post-COVID, more patients are living with cardiovascular disease than ever before, and our medicines have the potential to address this urgent need.

We believe NEXLETOL and NEXLIZET, can and will make a difference in the lives of patients around the globe. As February is American Heart Month, I'd like to reiterate the importance of raising awareness around heart disease, and proactively taking steps to reduce your LDL cholesterol levels and cardiovascular risk. With a top-line results of the CLEAR Outcomes trial, fast approaching, and next steps to advance our pipeline insight, our team is energized to execute on our strategy and demonstrate the overall strength of our organization. I would like to thank our colleagues and partners for their continued dedication and hard work to make our vision a reality.

Lastly, thank you all for joining us today and for your continued support and interest in Esperion. 2022 is sure to be an exciting year. Operator, we are now ready for Q&A.

Questions & Answers:


Operator

[Operator instruction] Our first question comes from Michael Yee with Jefferies. Your line is open.

Mike Yee -- Jefferies -- Analyst

Hey, guys. Good morning. It's Mike Yee from Jefferies, can you hear me?

Sheldon Koenig -- President and Chief Executive Officer

Hi, Mike. Yes.

Mike Yee -- Jefferies -- Analyst

Hey, good morning. We were thinking about the chronology of 2022, 23, and 24, and so far that 22 you'll finish the outcomes Q1 23. You'll get the data, file the data mid-23, and thenan approval in 24. Can you talk about how you would expect Scripps, and uptick a sales to uptick as you go through that? And how much, and how important actually getting the label is versus just getting the top-line data.

And talk about that because when we go back to like PCSK9, they were sort of alluding to the fact that you kind of need the label because that's where you get the contracts, and the data, and the publications, and all that. And that's really what drives the uptick. Maybe you could clarify how you think about the importance of just getting the data versus getting the approval on the label. Thank you.

Sheldon Koenig -- President and Chief Executive Officer

Great, thanks, Mike. So, first of all, good morning, and just to reiterate the timing that you denoted in the beginning of your question is absolutely correct. So getting the data is extremely important. As a matter of fact, once we have the data, we can actually go out and speak to payers at the time.

When we do have data, we don't necessarily need the label to speak to payers. That's important for us because as we mentioned before, one of the strongest headwinds for us, is our prior authorizations. And we believe that the data that will come out of the CVOT outcome study will really help minimize those headwinds, as it relates to prior authorizations. As it relates to having the data, and it being important right away, that's going to be a huge shot of awareness for us.

We believe that the study once it's presented at a major meeting and again, we mentioned in our prepared remarks, Dr. Steven Nissen is the primary investigator. As you know, Dr. Nissen loves to get behind the podium, and talked about the studies that he's behind, and that awareness is really going to send a message, and really bring to the forefront what next was there and next to talk can offer.

Related to prescriptions and inflection, I have Eric coming on that.

Eric Warren -- Head of Sales and Marketing

Great. Good morning, Mike. Good to hear your voice. So yeah, I'll just bring it back to your chronology, your timing.

So 2022 expects consistent growth from us leading up to CLEAR Outcomes. 2023 Q1 CLEAR is revealed at a congress happening in the first quarter. Expect to see a growth and bump associated with that, as well as the publication. And then 2024, we unlock our ability to have broader promotion.

And so that's when the sales representatives that can communicate to HDP is aligned with label. So expect the next wave of growth to happen.

Mike Yee -- Jefferies -- Analyst

Good. Thank you.

Jo Anne Foody -- Chief Medical Officer

Mike, this is Jo Anne Foody. From the standpoint of your comment regarding the PCSK9 and how long that took, I think if you may remember there was a significant delay in the final publication of the results on the order of eight months. Beyond that, we don't anticipate that, we anticipate a simultaneous presentation and publication as soon as possible, as Sheldon mentioned. And again, that will assist in the dissemination of the results, and our opportunity given our existing label to increase awareness while we await the final label in 2024, as you mentioned.

Mike Yee -- Jefferies -- Analyst

Thank you.

Operator

Our next question comes from Joseph Thome with Cowen and Company. Your line is open.

Joseph Thome -- Cowen and Company -- Analyst

Good morning, and thank you for taking my questions. The first one just on the slides themselves indicates that increasing access is kind of one of the key focus areas. Can you dive into that a little bit more? What can you do ahead of the CLEAR Outcomes data to increase access so you can be able to adjust kind of timing or severity of prior authorizations? Before that point, is it just getting to more centers? And then second, on the treatment guidelines, I know you've previously outlined from low-risk patients to extremely high-risk patients. Is this sort of a light switch that once you get the label expanded, you're going to get on all these treatment guidelines.

Is it possible to get on one and not the other kind of? How would the process should go? Thanks. 

Sheldon Koenig -- President and Chief Executive Officer

Hi. First of all, hi, Joe. Thank you. So as relates to prior authorizations and access, let me just start with the summary of access.

We actually have very good access for NEXLIZET and NEXLETOL. Our commercial access is approximately 90% and our Medicare access is 60%. Even that accounts where we don't have active Medicare contracts, we're actually seeing growth in these accounts as well. They're not denoted in the side that you see before you on the corporate deck, but it's something that we monitor.

As relates to prior authorizations, we're always looking, and working with accounts to see if we can streamline these prior authorization. I think one of the biggest obstacles for prescribing physicians is remembering that in our current label, patients who have ASCVD must be documented. And physicians are still learning on how to actually provide that documentation on prior authorization. It's really no different, that was also found with PCSK9 when they launched.

Again, as I mentioned earlier, once we have the outcomes study, that's going to significantly reduce that barrier. But right now, we actively work with accounts and our field teams. All of our field teams have individualized selling plans to the accounts that they deal with, in order to help physicians inform them on how to get through this prior authorizations. We also have the support of a third party called Asembia, and Asembia acts as a facilitator to help physicians and their staff also get greater prior authorization for our product.

As relates to guidelines, I'm going to have Jo Anne address guidelines.

Jo Anne Foody -- Chief Medical Officer

Well, thank you. Currently, we are in a significant number of guidelines. However, as you mentioned, right, there's an asterisk, if you will, that we don't have outcomes data. We anticipate with the outcomes data that the majority of guidelines, important guidelines, whether they be the European Society of Cardiology, as well as the American Cardiology, and American Heart Association guidelines, those will likely be updated quite quickly.

Then to your other comment around expansion. Currently, we do have great label for LDL reduction, but it does target patients social dimension with ASCVD, and on a background of maximally tolerated statin. With the CVOT, we will likely be able to remove the ASCVD and expand to a population of both primary and secondary prevention, those with-without existing cardiovascular disease, as well as remove the maximally tolerated statin, so we can be a therapy irrespective of statins. We anticipate that in contrast to the PCSK9, given that we are an oral, easily accessible therapy at lower cost, that we would have the opportunity for significant expansion of use, not only based on guidelines but with our payers and providers as well.

Joseph Thome -- Cowen and Company -- Analyst

OK, that is very helpful, thank you very much.

Operator

Our next question comes from Jason Butler with JMP. Your line is open.

Jason Butler -- JMP Securities -- Analyst

Hi, thanks for taking the question. You have a little more than a quarter since you announced the organizational changes. Can you speak to where you are today in terms of the experience with the hybrid business model, and how much data you have that can kind of speak to, how you make adjustments to the model throughout 2022?

Sheldon Koenig -- President and Chief Executive Officer

Hi, Jason, good morning. As relates to the restructuring that we announced back in October, we've come a long way since then. It doesn't seem that long ago, and maybe it wasn't from a couple of months' perspective. But what I'm proud of, as relates to this organization is we really haven't missed a beat, as relates to our performance, and our plan that we're executing.

And I say that because as you remember, we had about a 40% reduction in our workforce, it's highly disruptive. And typically when you have those types of large events, there's disruption in the field, there's disruption in the organization, etc. I think the organization as a whole has done an outstanding job, really working together, keeping on track, keeping with our claim that we will always have consistent growth, keep you on track with our CLEAR Outcome study, which we have done. And so it's coming along nicely, as it relates to today, and how it's all working and what we've seen so far.

As relates to the hybrid model of Eric, comment on that. 

Eric Warren -- Head of Sales and Marketing

Great. Thanks, Jason. Our model consists now of this balanced approach with three prongs. We've got the personal promotion, we've got digital promotion and we've got peer to peer.

We made these changes in the beginning middle part of October, and I'm pleased so far with results. So Q4, you saw the impact of the model, our ability to bear the disruption, and still deliver on our commitment for consistent growth. We have the ability to flex up and down elements of this model. We recently in the middle of January deployed the contract sales organization.

So far, we're seeing a good level of engagement, as we would expect with that team virtually engaging HCPs. Our digital activities, we've been able to flex and increase, that is composed of several components. And then from a peer-to-peer perspective, we're actually seeing increased in-person peer-to-peer, as well as our ability to digitally leverage peer-to-peer. So, so far, so good, Jason. 

Jason Butler -- JMP Securities -- Analyst

Great, thanks for taking the question.

Operator

Our next question comes from Judah Frommer with Credit Suisse. Your line is open.

Judah Frommer -- Credit Suisse -- Analyst

Hi, thanks for taking the question. I'm just curious as kind of  hopefully this Omicron wave wanes across the US. Are you seeing, or maybe you have any anecdotes around return to patients returning to doc's offices? Is that impacting scripts in any way? It seems like it's impacting sales reps ability to interact with docs. And then anything insights from the Daiichi side in terms of how they're handling.

I'm kind of returned to office maybe a little bit behind us in some of their territories, but kind of any [inaudible] that they'll be able to get at as people return to offices.

Sheldon Koenig -- President and Chief Executive Officer

Hi, Judah. Yeah, I think most of us believe that the Omicron variant is pretty much dissipated, and hopefully, we put COVID in the rearview mirror for everybody. Where we live right now, where we're coming from in Pennsylvania, masks aren't required, California, masks aren't required on. This is continuing to be a trend.

We are just on a call yesterday with our sales leader, and he also discussed that they're seeing more and more folks return to the office, patients, physicians, etc. So I do think that with Omicron dissipating, COVID may be dissipating, we're seeing this return to the office. And you may recall in my prepared notes, even with the snippets I mentioned out of Nature magazine, more now than ever, there's so many patients with either long haul COVID who have significant cardiovascular issues. As well as the patients who've already had cardiovascular issues who were not getting those issues addressed because of COVID.

They're afraid to go to their doctors, they're afraid to go to the hospital, etc. So we do think that patients will hopefully start readdressing their cardiovascular health. Again, cardiovascular disease is the number one killer in the United States and the world. We have two drugs today, NEXLIZET and NEXLETOL that can treat and lower LDL cholesterol.

And we're hoping now will be a time that we can make more awareness because of the fact that patients will have more freedom to return to their physicians' offices. Eric, anything that you'd want to comment.

Eric Warren -- Head of Sales and Marketing

Hi, Judah. I would just say back to the balance model. So having a balance model gives us the flexibility, to weather spikes in COVID and can't predict the future. But it's good to know that we've got a model again that isn't overly dependent upon in-person personal promotion, but we have the other pillars to help navigate whether spikes happen or not.

Judah Frommer -- Credit Suisse -- Analyst

Great, thanks.

Operator

Our next question comes from Serge Belanger with Needham. Your line is open.

Serge Belanger -- Needham and Company -- Analyst

Hey, good morning. My first question is on the net price per hour. I think Rick talked a little bit about that in its prepared comments, and his expectations that it would increase over the coming years. Just curious about the cadence of that increase for 2022, given the the 10% price increase that was implemented on June 1st.

And then secondly, for 2022 expectations. I know you guys don't provide sales guidance, but to this, if you care to comment on street consensus numbers, there is a wide range right now, but depending on where you look at, these tend to average out between $65 and $70 million for 2022. I'm curious if that's the number you're comfortable with. Thank you.

Rick Bartram -- Chief Financial Officer

Thank you, Serge, this is Rick. So on your first question on that price, I think if we go back from where we were in the first quarter of last year, we're really pleased with the adjustments that we made to the design of these co-pay card programs, which really had a pretty impactful erosion in our net price in the first quarter. So with those adjustments that we made through the year, we're pleased where we improved net price throughout the year. It's definitely something that we are constantly evaluating.

As we sort of think about 2022, there will be sort of ebbs and flows in that price. And just as you all know, the seasonality of the business, the first quarter there's a lot of commercial plans with deductible resets. Second half of the year, Part D patients get into the coverage gap, so they'll be a little bit of seasonality. We're focused on improving net price, but we think that cost outcomes that's going to provide some opportunity for us to improve net price beyond what we've been able to do so far.

And then your point on sales guidance, we're not providing guidance and we're not commenting on where consensus is. As Eric has mentioned previously, we're focused on growing the brands and executing on the sales model to drive top-line growth.

Operator

Our next question comes from Tom Shrader with BTIG. Your line is open.

Tom Shrader -- BTIG -- Analyst

Good morning. Thank you for taking the question. I wanted to see if you can give a little more detail on the prior auth process. Do you have a sense of what fraction of patients can meet with their doctor and simply get a prescription? Or how many of them then have to get another test and come back and maybe come back twice? Just a sense of how onerous the process is and how meaningful to see what will be on that front.

Thank you.

Sheldon Koenig -- President and Chief Executive Officer

Tom, good morning. Yeah, let me try to introduce B.J. Swartz. He's in charge of our market access, and HEOR group, as well as strategies,BJ if you want to come along with that

Betty Jean Swartz -- Senior Vice President of Market Access, HEOR, and Policy

Sure, Tom, it's nice to hear from you. As far as the prior authorizations, what we can tell you is literally there is a prior authorization for NEXLETOL and NEXLIZET for all the prescriptions, but it is to our exact label. And so whether we are preferred or non-preferred were required to submit prior authorization to the label. With that said, obviously, it's an onerous process and that is why we put together our prescription support program.

And with that program, we work with providers in the offices to ensure that they get the prior authorization completed, and on time so the patients get the prescriptions in the shortest period of time. And with the cardiovascular outcomes trial, we certainly believe that the prior authorizations will be lessened and we look forward to that as the trial is read-out.

Tom Shrader -- BTIG -- Analyst

And do you have any insight how often that requires a second visit, or a third visit? 

Betty Jean Swartz -- Senior Vice President of Market Access, HEOR, and Policy

From visits to the office, it doesn't require the patient to visit the office. It is more the onerous process of the physician providing the right documentation, so it's not necessarily on the patient, but it's more on the office to make sure they provide the right information that happens almost for every prescription. But because of the process, we have in place so long as they have the right diagnosis, the patient will get the product again in the shortest period of time.

Sheldon Koenig -- President and Chief Executive Officer

On your question, you mentioned around lipid tests, if I understood that properly, and how often do patients maybe come back? And if that was also part of your question, typically when the patient goes on the drug, they usually take the drug for about two months, get their lipid test and then come back after that. But I thought that was also one of your questions as well.

Tom Shrader -- BTIG -- Analyst

Yeah, thank you.

Operator

Our next question comes from Jessica Fye with J.P. Morgan. Your line is open.

Jessica Fye -- J.P. Morgan -- Analyst

Hey, guys, good morning. Thanks for taking my questions. Question on CLEAR Outcomes, So from the time the last May is hit in the study, can you talk about what you will need to accomplish to be able to report top-line data, and what you estimate for how long it will take to release top-line data from whenever you hit that last event?

Jo Anne Foody -- Chief Medical Officer

Yes, just this is Jo Anne, thank you for the question. So it's a quite complicated process. In fact, we are looking to begin close-out operations for the study. In fact, before we actually achieve that final sixteen hundred and twenty events, we'll do that through modeling and prediction and begin that process.

Hopefully, at the beginning of Q2 this year, start bringing patients in for their end of study, visit and anticipate that we would have a database lock fully by the end of this year. Obviously, then we need to clean the data, adjudicate the data, make sure that we have everything in regulatory, great publication, great data, and confident of a top-line result that can be communicated in the first quarter 2023. 

Jessica Fye -- J.P. Morgan -- Analyst

Got it. Do you guys have any reason to think that the MACE rule in CLEAR will slow down? 

Jo Anne Foody -- Chief Medical Officer

No, we've been tracking right on online, as predicted from the beginning of the study, in fact, irrespective of COVID, if anything, we've been tracking slightly ahead on a month-to-month basis and as Sheldon mentioned, just put in our 90% of our MACE for, as you may recall from prior conversations were well above 100% on our May three accumulation, which is our secondary endpoints.

Jessica Fye -- J.P. Morgan -- Analyst

Got it. And last one, can you talk about the pushes and pulls that might put you at the higher or lower end of your apex guidance ranges this year?

Rick Bartram -- Chief Financial Officer

As we sort of think about the business, and with the adjustments that we made in the fourth quarter of last year. The bands are fairly tight. As you know, we're in a relatively steady-state on R&D, principally related to the cardiovascular outcomes trial. And there'll be some ebbs and flows on the timing of CRO-related expenses, trial expenses, quarter to quarter.

But for the most part, those costs will be in line with the guidance, as well as what where we were for the full year 2021. On SG&A, those are also reflective of the adjustments that we made in the fourth quarter. We've realized those savings in the fourth quarter of this year, and now have a new steady state for the business. So we do expect that it will be fairly tight in those bands that we provided.

And to the extent that we can refine those further throughout the year, we will do to make it most helpful for everyone.

Jessica Fye -- J.P. Morgan -- Analyst

Great, thank you.

Operator

Our next question comes from Jeff Hung with Morgan Stanley. Your line is open.

Jeff Hung -- Morgan Stanley -- Analyst

Hey, everyone, thanks for taking the questions. A follow-up question on the price increase earlier this year. Do you see this as a regular percentage increase going forward? Is that a one time thing got ahead of outcomes data or how are you thinking about price increases over time?

Sheldon Koenig -- President and Chief Executive Officer

Hi, Jeff, thanks for your question. So we don't really comment on our pricing strategy, where we think it's appropriate based upon economic conditions, demand, etc. There's actually a very strategic approach when we decide on when we'll take pricing, and what that price increase will be. But we did feel this was the appropriate time based upon recent data that had been presented at several meetings.

And as we move forward and have other price increases, we'll certainly keep everyone updated.

Jeff Hung -- Morgan Stanley -- Analyst

OK. And then they're still on partner geographies, any update on how you're thinking about partnering additional regions or how this conversation may be going? Thanks.

Sheldon Koenig -- President and Chief Executive Officer

So right now, we're really focused on the US, and I'm really focused on the consistent growth that we've talked about before, again NEXLIZET and NEXLETOL, which all are available today. So it's really driving that consistent growth today. And then as we get to CVOT, of course, we'll have the inflection point related to, un-partners geographies. It's something that we do have discussions about, we do have a strategy around it, right now, though it's more of a secondary priority for us.

And again, I think as we go through the next year or so, we can provide more updates of what we're doing with those geographies. And that reminds me, by the way, the question was asked earlier about a Daiichi-Sankyo. So of course, Daiichi Sankyo has Europe, and also the ASCO region, and they're doing quite well. They've been doing very well in Germany, they recently launched in the UK as well.

They have over 49,000 patients on drug, and it was asked earlier about Omicron over having an effect and they drove it able to navigate around COVID, get to see physicians, etc. So in those partner geographies with Daiichi Sankyo, they're doing very well. But I just want to get back to the answer of a question that was also asked earlier about Daiichi Sankyo territories.

Jeff Hung -- Morgan Stanley -- Analyst

OK, thank you.

Operator

Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi -- Goldman Sachs -- Analyst

Thank you. Good morning. and thank you for taking our questions. Most of my commercial questions have been answered, but I want to maybe ask Jo Anne just to revisit CLEAR Outcomes of our moment here, which is congratulations on achieving 90% of your target.

I guess my question here is, as you think about sort of the impact from COVID and so forth, any other puts or takes like you would comment on just how to think about your primary endpoint here since the trial is designed to have 95% power to detect a 17% risk reduction. And any commentary on just how the backdrop in the environment might be affecting that from your perspective. Thank you.

Jo Anne Foody -- Chief Medical Officer

Paul, thank you so much for your question. I think obviously, it's top of mind, has COVID impacted the study? I'll give you some thoughts on that. So first of all, remember that the entire trial was enrolled well before COVID in 2019. We've worked tirelessly throughout this study, working with our CRO, our ARO,  and multiple vendors to ensure the integrity of the trial and really minimize impact from COVID.

We've been working with regulators as well, tracking that throughout the study. And in fact, the study has been identified, if you will, as the best practice for how, unfortunately, to conduct a large cardiovascular outcome trial during COVID. in general, yes, there are individuals that have COVID within the study. The events have not been significantly changed in either type or a proportion relative to COVID, and that gives us really great confidence.

The study had been running to all our surprise, but due to a lot of hard work, as we would have anticipated this study to run prior to COVID. So the events are tracking as we would have anticipated. As you can see, with the accumulation of 90%, they're not overly enriched by COVID-related events. And again, we're looking for a successful close out of the study, and hope that this really becomes again the best practice of how to engage patients, keep these patients in trials through multiple multiple challenges.

Remember that the randomization right 14,000 patients randomized really also gives us great certainty and confidence that COVID would affect both sides of the equation and would not impact the study of this size, scale or scope.

Paul Choi -- Goldman Sachs -- Analyst

Great, thanks for that, Joanna. And maybe just as a follow-up, since you are talking about presentation at a medical conference soon after the top-line results in the first quarter, I think the American College of Cardiology is In early March, as is probably the right venue for us to look at.

Jo Anne Foody -- Chief Medical Officer

Well, it certainly could be the timing seems to make sense, Paul, as know. And it is a major international cardiovascular congress that could be a potential.

Paul Choi -- Goldman Sachs -- Analyst

OK, great. Thank you very much.

Operator

There are no further questions. I like to turn the call back over to Sheldon Koenig for any closing remarks.

Sheldon Koenig -- President and Chief Executive Officer

Great. Thank you so much. And again, thank you for everyone for participating. Just a few closing remarks.

Again, just want to reiterate again the news of the fact that we have 90% accumulation of our base for end point. And with over $309 million on the balance sheet, Esperion is well capitalized and positioned to execute on this strateg. We know even going back to October, our business has been optimized to deliver consistent growth up to the results of our CVOT, which will be key in unlocking exponential future growth of our NEXLETAL and NEXLIZET brand. But again, I want to remind everyone, again with next week that the next job being available now, the need that we mentioned earlier to address cardiovascular health, we again reiterate that we want to provide consistent growth throughout the year.

And then lastly, this is just an exciting time for Espirion, and we look forward to updating you in the coming months. And again, thank you so much for today's participation and this is the end of our conference call for today. Have a great day and talk to you soon.

Operator

[Operator signoff]

Duration: 44 minutes

Call participants:

Ben Church -- Head of Corporate Communications and Investor Relations

Sheldon Koenig -- President and Chief Executive Officer

Rick Bartram -- Chief Financial Officer

Mike Yee -- Jefferies -- Analyst

Eric Warren -- Head of Sales and Marketing

Jo Anne Foody -- Chief Medical Officer

Joseph Thome -- Cowen and Company -- Analyst

Jason Butler -- JMP Securities -- Analyst

Judah Frommer -- Credit Suisse -- Analyst

Serge Belanger -- Needham and Company -- Analyst

Tom Shrader -- BTIG -- Analyst

Betty Jean Swartz -- Senior Vice President of Market Access, HEOR, and Policy

Jessica Fye -- J.P. Morgan -- Analyst

Jeff Hung -- Morgan Stanley -- Analyst

Paul Choi -- Goldman Sachs -- Analyst

More ESPR analysis

All earnings call transcripts