Q4 2020 Esperion Therapeutics Inc Earnings Call
Ladies and gentlemen, thank you for standing by and welcome at this time all participants are in a listen only mode.
During 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 of a debenture of Investor Relations and corporate communications at Asbury on please go ahead Sir.
Yeah.
Thank you operator, good afternoon, and welcome to experience fourth quarter and full year 2020 financial results and the company update conference call I've been church, and I'm responsible for Investor Relations and corporate communications here out of Spirit with me on today's call are Tim <unk>, President and Chief Executive Officer Sheldon Koenig.
<unk> operating officer, and Rick Bartram, Chief Financial Officer.
Once you remind callers of the information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act of 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 the.
These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and SEC filings.
Content of this conference call contains time sensitive information that is accurate only as of the day of this live broadcast February 23rd 2021, we enter take no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call and webcast.
As a reminder of this conference call and webcast are being recorded an archive we issued a press release. This afternoon detailing the content of today's call. A copy can be found at www dot of spear and dot from within the investors and media section. We will begin with prepared comments and then open the call for your questions. Following today's call of the team will be available for follow up.
Please email investor relations at of Spirit on Dot Com, just schedule 15 minutes to speak with our team I'd now like to turn the call over each of our president and CEO, Tim They laid then Tim.
Thank you Ben and good afternoon, everyone. We appreciate you joining us today as we update you on the story on and the significant opportunity that we believe still lies ahead since we announced preliminary financial results. Several weeks ago will keep our prepared remarks brief and get into Q&A.
Now for many 'twenty 'twenty will be remembered as the year everything changed while the world changed around us and obvious ways of Siri.
The on change fundamentally as a company.
We received our first marketing approvals for next low tall oak assets and excellent debt.
The first ever non statin fixed dose combination tablet of dumping of like asset and a debt of mind 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 realize our team did.
We also secured additional marketing approvals in Europe, the U K and Switzerland under the brand names, the London and New standard we've worked with our EU commercial partner Daiichi Sankyo Europe to launch of Germany in Q4, while earlier announcing a strategic collaboration with Otsuka pharmaceuticals 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 F. D. A we launched our medicines of 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 patience venture to their health care providers and avoidance of the virus.
All thing and fewer written statin prescriptions and non statin prescriptions for lowering bad cholesterol of of the year. Before this was the first time in history that statin prescriptions declined year over year, but despite this 21000 patients in the U S film next low tall and excellence of that.
In 2020, we continue to hear resoundingly positive feedback about how next little of next laws that are working the lower patients LDL cholesterol levels in combination with diet and maximally tolerated statin, which is an important metric for our future success.
As the lipid management company, we are constantly seeking to better understand patient experiences, especially those whose needs are being met by current treatment treatment options. We worked to discover develop and commercialize innovative medicines and combinations with established medicines that are easy to get.
It's easy to take and easy to have we.
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. The see the O T that will determine the ability of epidemic assets to reduce cardiovascular.
Such as heart attacks and strokes we've.
We've invested in the C. D O T. Because there is tremendous unmet need for additional drugs net reduce the risk of cardiovascular events. The number one leading cause of death in the world.
We believe patients around the world deserves better than the status quo. We aim to change the therapeutic landscape of landscape that has resulted in an overall under investment in the development of new cholesterol lowering therapies for cardiovascular disease.
In particular.
There is the significant need among people who can't reach their LDL cholesterol goals with maximally tolerated statin, who as a result are at high cardiovascular risk and the need of non statin options.
This statin intolerant patient population as the group you would have heard us speak about many times in the past there are more than 35 million patients considered statin intolerance and the U S, Japan, and the EU statin intolerance impacts of the 20% of individuals who have been treated with the statin.
Literally tens of millions of adult need the lowered their levels of bad cholesterol beyond diet, and maximally tolerated statin and the vast majority of neat convenient non statin once daily pills that are affordable.
[noise] clear outcomes.
Ryan nearing of event driven trial, the first of its kind of focusing on statin intolerant patients with over 14000 patients enrolled it is powered for success and is optimally designed to demonstrate the full potential of bump of Delek asset impressive LDL cholesterol lowering for patients that.
Can't or won't take statin statin like levels of Hs CRP reduction in a non statin oral medicine and the potential for showing additional positive glycine like effects.
Despite the pandemic the C V O T remains on track in fact, we collected 50 per cent of the major adverse cardiac events. The primary end points during the third quarter of 2020 and remain on target for the second half of next year.
Positive results from the CBL team 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 Sankyo in Europe, and Otsuka in Japan, both of which have extensive experience in the cardiovascular field in Germany alone 4000 patients were on our medicines.
Within the first two months of the launch by Dfc.
For Japan, Otsuka plans to initiate the phase two study in Q1 in fact this quarter. We continued to work through the last major piece of the global debt. The Delek asset net work completing of 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 the world partnership of Spirit will still own exclusive rights to almost 70% of the global benefit of like acid franchise value.
In closing 'twenty 'twenty will be remembered as the year everything changed including leap forward for patients struggling with high levels of bad cholesterol, we're grateful to the patients and health care providers, who place their trust in our company and our medicines, we thank our shareholders for your ongoing support of of sphere.
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.
And 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 the 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 highlights by 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 of lead of the global cardiovascular franchise and work directly on W and by Jordan.
From there I moved to Sanofi to run their global cardiovascular business, including Praluent 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'd been in the cardiovascular space for a very long time and have directly work with all of the LDL C. Lowering solution the market has the offer.
I plan to apply my learnings from these past launches to really accelerate the commercial adoption of next low Paul Index was at in the U S and ensure the full potential of our medicines 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 of current treatment options are not enough for patients to reach their LDL cholesterol lowering goal.
That's the Deutsche asset and its combination of when does that the market now marketed as Netflix All index is that here in the U S are the solutions these patients need.
Easily fill the gap between diet maximally tolerated statin and injectable PCF canine inhibitors as once daily oral non statin medicines.
I joined the screen, because I want to be part of the solution delivering millions of patients the necessary therapy to battle elevated LDL C. Biomarker that is known to leads of cardiovascular disease. The worlds number one killer accountable for one of out of every three deaths and whats worth.
It is asymptomatic a silent killer.
On the more personal note after my bathroom of cancer of leading Kols made the comment in the meeting once that I always worried about my cancer Attorney. He said the more worried about your risk of dying from CV disease and cancer.
The wake up call I, apparently needed to the cardiologist.
As I assume or I was at the high risk with the baseline LDL C level of 140 milligrams per deciliter and of the family history. So at the time when people are foregoing their usual medical checkups and active healthy lifestyle. As a result of this pandemic managing ldlc is more important now than ever.
It is clear to me next little index was that did not get the standard launch opportunity afforded to all other ldlc medicines before us.
We do have an opportunity to make the accelerate impact as we all emerge from this pandemic.
Although we cannot give you a specific day week or month, we are certain with the pandemic receding and an easing environment patients will return to physicians offices in.
<unk> it does not matter if but when.
In the interim the spirit on the implementing a number of initiatives, which I will discuss in the moment to ensure we are the best positioned to capture patients as the reef turned to physicians offices in the wake of the pandemic, but also for long term sustainable growth of the franchise.
Since my arrival to the spirit on identified three areas that would the refined commercial strategy will garner increased awareness of momentum and 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 MSL that we'll look to leverage.
And the sales are instrumental in building a strong scientific platform, while also developing relationships with kols, who influenced broader adoption of medicines through educating our respected health care professional community of the large GAAP in ldlc lowering of medicine and need for additional therapies.
Driving awareness of next little index of debt and the benefits. They can provide patients is the first half of my to do it.
Physician retention has largely been diverted during the pandemic, but now as this hyper focus abate 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 next the Tau franchise in this manner should we be granted the indication expansion, but the.
Until that reads out we are looking to put our commercial team with the 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 collaborate the aspira non mission 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 theyre demonstrated the ability that facilitate the physician use of our product is in this way will translate into longer term prescription growth.
But not only are our products. The fact that 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 outcomes research specialists 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 of our medicine.
It was not enough to just ensure physicians know of our medicines.
It is critical that healthcare providers understand the appropriate patient population and we're along of the treatment paradigm our products fit.
This was the motivation behind our virtual peer to peer educational medium to the HCP debt. We continue to this day.
The team and I are working to create a virtuous.
And reinforcing cycle enhanced 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 HCP.
The last area I'll focus on this 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 brand tiers with the lowest patient out of podcast.
We are taking the action to encourage improvements on the onboarding and pull through of our managed care coverage.
We are integrating of reimbursement specialty and type of market access strategy to bridge the gap between contract completion and implementation.
What this means is we are building and 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 come online, especially on the Medicare part D side, leading to improve the access to our medicine and higher of potential for prescription volume.
Cumulatively these initiatives require little to no additional costs, 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 statin medicines, such as Netflix Hall index was at and this team's ability to execute I would not have joined this purion. 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 per remarks on our financial performance.
Thanks, Sheldon today I'd like to spend my time addressing how COVID-19 impact on our launch and our U S product revenues from acquired and optimization of the experian 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-19 interrupted our commercial plans and disrupted the conventional health care model associated with normal health management practices. For example, regular physician office visits lab tests and prescription refills seemingly overnight the commercial <unk>.
Ironman, we were depending on for a successful U S launch stopped in its tracks.
For all of our hard hard fought efforts and adaptations on the commercial side.
Of the business, we generated $13 million in U S product revenue per the full year of 2020, and total revenue of 2200, 27, and a half million dollars 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.
Savings.
The first being inventory.
As a result of COVID-19 negatively impacting demand and our wholesalers more cautiously managing inventories, we adjusted our budgeted production plants last year, resulting in the associated savings.
As of our original marketing budget was based on assumptions of a normal market conditions and pre COVID-19 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 Mexico toll index was that they 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 work force 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 million 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 noncash 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%.
To review.
R&D expense for 2021 is expected to be between 122 of $130 million slightly down from last year, but generally just 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 million 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 of rest of world deal for.
Further our existing revenue base funding agreement with Oberland 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 of that experience has over $1 billion in future milestone payments from our existing ex U S 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 of proofs.
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 the close with this the.
COVID-19 pandemic.
It 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 the spirit and our partners remain very confident in the long term potential of our medicines. We think the future is bright for of scary and we'll 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 the question on the phone line. Please press. The Star then the one key on your Touchtone telephone to remove yourself from the coupons of the pound key please standby, while we compile the Q&A lost share.
And the first question coming from the line of Martin Auster with Credit Suisse. Your line is now open.
Hi, everyone. This is mark on commodity thanks for taking my question. So I guess my first question is I saw that you had.
Tim I saw that you had mentioned that there are 4000 patients in Germany on <unk> assets.
And so would you be able to help put.
That and in perspective relative to the pace of the launch in the U S and I guess, where any of these 4000 patients in expanded access programs and any additional detail you could provide.
Sure Mark this is Tim so.
We are we provided the number it is I think by all accounts an impressive number in it.
It really cements the decision that we made almost two years ago to.
To partner with Daiichi Sankyo as you'll remember we had said at the time that they have.
And incredibly successful cardiovascular commercial organization numbering more than the 1000 people across Europe.
And they had been phenomenally successful with the launch and.
The launch of which links the honor several years ago. So we certainly expected they expected to perform extraordinarily well there.
Our understanding is they're running a very similar.
Playbook, if you will to.
The launch of the Axion and I think these early numbers.
The early patient numbers indicate the strength.
Of of their commercial organization.
I think what we can say is that the sort or not.
These are true commercial patients pain.
Paying patients not.
Not in any way patient assistance programs that we're aware of so I think it's it's good numbers, but like I said I think it certainly.
And early indication and it's early but an early indication of.
Of the capabilities of of.
The organization in Europe Daiichi Sankyo.
Yeah, I agree it will definitely be worth of work 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 world partnership discussions have been going and if there's any update in terms of how we should be thinking about potential timing.
The size of 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 we feel good about that is 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 world.
And.
And so we again, where we're tracking.
Tracking toward the towards that timing.
Okay, great. Thanks, Thanks again for taking my question.
You bet.
And our next question coming from the line of Thomas <unk> with <unk>. Your line is open.
Hey, guys. This is Julian on for Tom Congrats from 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 the lipid specialists versus GPS and also maybe any prevailing geographic trends such as regional center versus community uptake and then Rick U S revenue from <unk> implies an improving.
Gross to 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 that player here.
Hey, Thanks, Sheldon can I ask you to take the first questions and then the tip it to Rick to respond to the others.
Yes, well the thank you so much and thanks for the question so as it relates to the prescribing what we're seeing is that an overall prescribing you.
You may recall at the Jpmorgan, we showed where the AMG status had decreased.
We still see a decrease of statin use by about 9% currently on.
But we are seeing.
This slowly rise and come back.
As it relates to prescribers.
Essentially cardiologists versus PCP.
I think it's more so.
The contribution by by both.
Obviously, there's more PCP the narrower cardiologists. So you do see slightly more prescriptions from primary care physician.
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 our sunstate doing a better job of growing out the COVID-19 vaccine, which I think we of all state it had really slowed.
Patients and physicians, even coming back for treatment.
We do 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 <unk>.
Some patients coming back slower of some patients coming back quicker.
Quicker now we have not gotten intense research and that that's just the overall and looking at some of our some.
Some of the data that we receive on a weekly basis.
Thanks, Sheldon Rick true.
Yeah sure. Thanks, Julien So as you know we've been pretty consistent that we we don't disclose our gross to nets really for competitive purposes.
As we think about gross to nets were pleased with where our gross to nets are currently at and as Sheldon mentioned in prepared remarks, we're going to have continued plans coming online, particularly in the in the part D space, but overall.
Where we're at and obviously as we proceed ahead and and have increases in volumes.
Things will start to level out as all of the plane the plants come online.
Okay, great very helpful. Thank you.
Thanks Julien.
And our next question coming from the line of Michael Yee with Jefferies. Your line 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 youre seeing in the environment, we hear different things from different types of of doctors and different types of of medicine should maybe just make the comment.
About that and as that relates to your confidence if COVID-19 is an issue about sequential acceleration do you feel confident you should see a pickup in sequential growth I think you did $3 three going to 8 million, which was a good number in the fourth quarter. So do you see that kind of ramp as Covid <unk>.
Thanks.
To talk about those two things in there of a follow up yes.
Okay great.
Sheldon can I tip those to you.
Yes will do and thank you Michael for your for your question.
Just as it relates to Ah 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 what we're seeing is it's a slow trickle back January was still the deadliest months as it relate to.
The Covid and as you know, we just went over the 500000 deaths.
<unk>. Unfortunately, but you have 2020 has taught us anything it's really to be flexible and really monitored the situation, we're not necessarily giving specific timeframe of.
When will 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 we expect that our growth will accelerate.
But what we're waiting to see is how quickly the vaccination rollout will occur and with that we will 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 of getting better your commercial work should accelerate sequential growth just because you share that people are staying on and each quarter or each month, you should have more people coming on should do you think that acceleration should be the right way to think about it each quarter.
And as we move forward with each quarter and as more patients are.
I think vaccinated.
The more offices positions. They themselves are vaccinated, yes, I mean, our hope is that patients who have resumed going to offices.
The thing that we've learned is that patients were not truly getting their physical telehealth doesn't really work in cardiovascular medicine, we have researched the chose that and therefore patients werent, even getting the lipid panels. So I think by default as.
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 physicians offices.
We would hope that based upon the our initiatives that we will see acceleration in our growth.
The matter of timing of.
The vaccination and how quickly we of 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 vaccinations and people feeling more comfortable going to their physician.
Yeah, that's good for 'twenty one.
And then last question relates to your starter packs can you just you had a big number there in the slide deck can you just from lenders how starter packs work do people stay on them for a while do they transition of commercial maybe just any comments from remind me of how those work. Thanks.
Sheldon.
Sure.
Yeah.
Starter packs are essentially it's really samples its distribution of samples in our samples are distributed.
<unk> essentially all physicians in our target audience.
We have distributed quite of bit of samples and allows the physician tried the patient on the drug and it's typically a seven.
The 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 guys.
Sure.
Thanks again, Mike.
And our next question coming from the line of Geoff Meacham with Bank of America. Your line is open.
Hey, guys just some of your Barrett thanks for the question.
Tim I wanted to ask you one 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 is it mainly focusing on earlier stage program and then the follow up to that.
External BD, 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 center.
You know, whether we should expect a more aggressive approach for the 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 of the commercial success of <unk>.
To the.
The cardiovascular outcome study the clear outcome study and the success of that study, which I think as you've heard of <unk> is progressing extraordinarily.
The extraordinarily well, especially in in the broader COVID-19 environment. So.
Nothing more to say at this point on business development.
Really like I said this organization is entirely focused on those those two drivers.
And our next question coming from the line of Chad Messer with me <unk> Company. Your line is now open.
Great. Thanks, Good evening, Thanks for taking my question.
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 the uncertainty in the environment just wondering with that.
Pretty tight range.
Granted a very favorable comp to <unk>.
In 'twenty do you think you have enough.
Optionality to pursue.
Things in a more favorable environment.
Uh huh.
Obviously, we all have a baseline and an upside and the downside case it seems like you've got yourself.
And the narrow window, just just wondering on you know whether you can comment on whether you feel you could be aggressive enough if the situation of warranted.
Sheldon do you want to do you want to comment thanks Chad.
Sure Yeah, So I think based upon.
Where we are today and the initiatives that we're putting in place.
Think that yeah, 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 that.
Not only of 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 costs money. These are things that just take thinking time.
And in doing that and essentially really being very purposeful in our strategy and the positioning of our products I think we're well equipped in.
To move forward and again to accelerate growth in 2021.
Alright, well here, here's the hoping for for for high quality problems. Thank you.
Thanks, Matt.
Thanks, Jeff.
Yeah.
Okay.
And our next question coming from the line of Joseph Thome with Cowen 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 fall of next level fit.
Is there a specific patient population thus far that you are surprised isn't coming on faster or is there of Pacific specific message that you think is kind of getting lost or is it mostly just COVID-19 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 yeah.
Yeah great.
So Tim.
Yes.
Yeah, So I apologize for that so as it relates to.
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 to your point that was the big hobby with Covid on due to the fact that the company launched during Covid that you're aware of that.
Somewhat lost.
And this goes back to why we really need to reestablish our scientific platform of 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.
The next few months and so forth, we'll definitely update.
Update you as it as it relates to that.
Your second question was if you could just giving you repeat your second question.
Yes.
The real world compliance.
And refilling.
Han results of real World compliance, what we've seen we've actually looked at re sales and we've actually benchmarked ourselves to other products.
The other commonly used and we see the majority of patients are refilling their prescriptions, which is a good time.
Great. Thank you very much.
Sure. Thanks Joseph.
Our next question coming from the line of Derek <unk> with Stifel. Your line of cell phones.
His line is coming in.
Technical issues. Our next question coming from the line Paul Child with Goldman Sachs. Your line is now open.
Hi, everyone. Thank you for taking our questions. This is Charlie on for Paul two quick ones from me. If that's okay. I was just wondering where we.
Wondering if in 2021 other plans for a 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 and the <unk>.
Quarters numbers. Thank you so much for taking the questions.
Yes. Thank you.
Rick can I take that to you.
Yeah, so on those.
The Copay program is something that's important to us we're obviously going to continue to evaluate that but that is intact for 'twenty one and.
Short answer no impact on inventory in terms of revenue.
Okay.
Great. Thank you so much.
Yes.
And I'm showing no further questions at this time this.
This concludes today's conference call. Thank you all for participating you may all disconnect.
Thank you so much thank you.
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