Palatin Technologies Inc (PTN) 2021 Q4 法說會逐字稿

Hello, ladies and gentlemen, and welcome to Palatin's Fourth Quarter and Fiscal Year-End 2021 Operating Results Conference Call. As a remainder, this conference is being recorded. Before we begin our remarks, I'd like to remind you that the statements made by Palatin are not historical facts and may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission.

Please consider such risks and uncertainties carefully in evaluating these forward-looking statements and Palatin's prospects. Now I'd like to turn today's call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatin.

Thank you. Good morning, and welcome to the Palatin Technologies Fourth Quarter and Fiscal Year-End 2021 Call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Executive Vice President, Chief Financial Officer and Chief Operating Officer. On today's call, we will provide financial and operating updates. I will now turn the call over to Steve to provide the financial updates.

Steve?

Thank you. Thank you, Carl, and good morning, everyone. For framing purposes, and as Carl will expand on, Palatin's strategy is to advance our melanocortin-based anti-inflammatory and autoimmune programs with an ocular focus. Regarding Vyleesi, which is FDA approved for the treatment of hypoactive sexual desire disorder, or HSDD, in premenopausal women, our goal with this program is to demonstrate value in the marketplace by increasing health care provider awareness, patient engagement and market access, with an objective of relicensing the U.S. rights to a committed women's health care company.

And regarding progress, we are making progress. And this is with a limited and measured investment. For the quarter ended June 30, 2021, gross product sales increased 28%; net revenue increased 149%; and total prescriptions increased 17% over the quarter ended December 31, 2020, which is Palatin's first full quarter of Vyleesi operations. Refill rates increased over the quarters ended December 31, 2020, and March 31, 2021. Market access and reimbursement coverage also increased over the quarters ended December 31, 2020, and March 31, 2021.

Regarding revenue and getting into our fourth quarter and fiscal year ended 2021 financial results. Total net revenues consist of net product revenues of Vyleesi and license and contract revenue related to Vyleesi. Vyleesi gross sales for the quarter and year ended June 30, 2021, amounted to $1.2 million and $4.7 million, respectively, with net product revenue, net of allowances and accruals, of $80,504 and negative $283,286, respectively. Palatin recognized no product revenues for the quarter and year ended June 30, 2020, because we didn't get the product back until July of 2020.

Palatin did recognize $94,689 in license and contract revenues for the quarter and year ended June 30, 2021, and that was related to our license agreement with Kwangdong for the Vyleesi rights to South Korea. And this compared to $117,989 for the year ended June 30, 2020, related to our license agreement with AMAG Pharmaceuticals.

Regarding operating expenses, for the quarter and year ended June 30, 2021, were $13.9 million and $33.2 million, respectively, compared to $7.4 million and $23.7 million, respectively for the same periods of 2020.

I'm going to expand a bit in some of the other areas, but that $13.9 million of operating expenses included approximately $4.5 million of an adjustment related to our termination with the license agreement with AMAG, and that was noncash and nonrecurring. The increase in operating expenses for 2021 was primarily due to the recognition of noncash expenses on the Vyleesi license termination agreement, which I just mentioned, and also an increase in the selling, general and administrative expenses which primarily were the commercial-related expenses for the Vyleesi program.

Moving over to net loss and cash flows. Palatin's net loss for the quarter, very close to the amount of the operating expenses less the revenue was $13.9 million and $33.6 million or $0.06 and $0.14 per basic and diluted common share, respectively, compared to a net loss of $7.3 million and $22.4 million or $0.03 and $0.10 per basic and diluted common share, respectively, for the same periods in 2020.

As I mentioned, just with the operating expenses, the main difference for the quarter was the noncash nonrecurring adjustment to the Vyleesi license termination agreement and also some increases in the selling and G&A, primarily related to the commercial expenditures for Vyleesi.

Cash position -- I'm sorry, cash flows rather. Palatin's net cash used in operations for the quarter and year ended June 30, 2021, was $8.5 million. And the main difference -- even though we had the operating expenses of $13.9 million and the net loss very close to that, the reason the net cash used in operations is significantly less, of $8.5 million, is that for approximately $4.5 million noncash, nonrecurring adjustment related to the Vyleesi termination agreement.

And we also had $22.6 million of net cash used in operations for the full fiscal year, June 30, 2021. And this compares with net cash used in operations of $6.1 million and net cash provided by operations of $41.3 million positive cash provided there, respectively, for the same periods in 2020.

Moving over to the cash position. As of June 30, 2021, Palatin's cash and cash equivalents were $60.1 million, with $1.6 million of accounts receivable compared to cash and cash equivalents of $82.9 million with no accounts receivable as of June 30, 2020. Based on our current operating plan, we believe that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of calendar '22.

Carl is going to go a bit more granular, but this does include the inflection points of data readout for our Phase III dry eye disease trial and also data readout on our ulcerative colitis Phase II trial in the second half of calendar '22.

At this time, I'll turn it back over to Carl.

Thank you, Steve. We are continuing to operate under the conditions imposed by the ongoing COVID-19 pandemic. To date, the adjustments we have made have allowed us to continue to advance our preclinical, clinical and commercial programs while maintaining the safety of our employees, patients and health care providers and partners.

Before I get into discussing our clinical and development programs, I'd like to emphasize the following concerning our Vyleesi operating activities. Upon return of Vyleesi last year, we undertook an extensive review of the Vyleesi commercial infrastructure and activities. Results clearly indicated that a substantial makeover was needed to support Vyleesi commercialization and relicensing.

This was not a trivial or short-term project. Under Steve's leadership, the Vyleesi commercial infrastructure has been redone and the changes that have been put in place have dramatically improved the patient experience, patient access, relationship with subscribers and the profitability of Vyleesi. We are now in a position to relicense Vyleesi to a committed partner, ensuring the continued availability of Vyleesi as a treatment option for premenopausal women with hypoactive sexual desire disorder and a continuing return on our investment.

At this time, I would like to present some of the key objectives of our research and development program. Across a multitude of inflammatory and autoimmune diseases, there remains a vital medical need for new treatments to provide patients and clinicians with safe and effective options. We are working to advance a new treatment modality for patients suffering with these inflammatory conditions with a primary focus on ophthalmic diseases such as diabetic retinopathy, dry eye, uveitis, all of which utilize our unique understanding and expertise in developing drugs that modulate the melanocortin system.

Over the past year, we have put in place the infrastructure, scientists and research and clinical development activities that we believe, if successful, will demonstrate the broad utility of the melanocortin system as a target for a variety of new efficacious drugs for treating these diseases. Our research scientists are using the latest in genomic, proteomic and cell biological techniques to advance our fundamental understanding of how the melanocortin system resolves inflammation and promotes tissue healing. The results of these activities are already helping to guide our clinical development programs.

Our clinical development programs are primarily focused on developing melanocortin-based treatments for ocular indications. However, we are also conducting small proof-of-concept studies for nonocular indications. These studies are designed to demonstrate the broad utility of the melanocortin system as a new target for drug development and support our technology licensing efforts. Of course, our ultimate goal is the development of new safe and effective drugs that advances the treatment options for patients.

As we stated, the melanocortin system plays a critical role in protecting the eye from harmful inflammation, and we are developing multiple melanocortin-based products for ocular diseases. Topically delivered PL9643 is our most advanced melanocortin agonist for treating ocular diseases that affect the tissues that comprise the anterior segment or front of the eye. The first indication for PL9643 is dry eye disease, and we have, as we previously reported, positive data from a Phase II study.

In the last quarter, we have had a successful end of Phase II meeting with the FDA, where we reached agreement on the key aspects of the PL9643 Phase III clinical development program. These include patient population, endpoints and clinical trial designs for the first of 2 Phase III pivotal registration studies. First PL9643 Phase III dry eye disease study called MELODY-1, will evaluate the safety and efficacy of PL9643 versus vehicle control in patients with moderate to severe dry eye disease over a 12-week treatment period.

The study is targeted to enroll 240 patients, but includes a interim data assessment to be conducted by an independent data monitoring committee that will allow us to increase the number of subjects if needed, thus reducing the risk of an underpowered study. Three co-primary and 3 key secondary endpoints will be comprised of signs and symptoms of dry eye disease and were determined based on the detailed analysis of the Phase II data.

MELODY-1 will begin enrollment in the fourth quarter of calendar 2021, with an interim data assessment in the first half of 2022 and preliminary data is anticipated early in second half 2022. If successful, Palatin will initiate the second Phase III PL9643 dry eye disease study called MELODY-2, and an open-label safety study called MELODY-3. If successful, 3 MELODY PL9643 dry eye disease studies will provide the safety and efficacy data required to file a new drug application with the FDA.

The emerging profile of PL9643 with its rapid therapeutic onset, excellent ocular tolerability and safety profile is a potentially distinct advance in dry eye therapy. If the Phase II results are confirmed in the upcoming Phase III clinical study, we believe that PL9643 has the potential for substantial penetration into the multibillion-dollar dry eye disease market.

We believe that PL9643 and other melanocortin agonists will have utility in treating other front-of-the-eye diseases, and we are planning to conduct a clinical study in a second front-of-the-eye indication in the first half of 2022.

The indication for the study has not yet been finalized, but will be based on data from our research and clinical need. Over the past year, we have made significant advancement in understanding the potential of targeting the melanocortin system for treating back-of-the-eye diseases such as diabetic retinopathy and macular edema. In preclinical models of retinal injury and diabetic retinopathy, treatment with our peptide, PL9654, a melanocortin agonist improved retinal morphology, protected against photoreceptor cell loss and very importantly, maintained vision.

PL9654 data supports advancement into clinical development, and we are currently working on developing a formulation for a sustained release of PL9654 that would be administered by intravitreal injection, a common technique used to deliver drugs for treating retinopathies. The current market for various retinopathy drugs is in excess of $10 billion annually and is anticipated to continue to grow. There remains a large need for new innovative treatments for retinal diseases. And we believe PL9654, although early in its development, has tremendous potential to positively impact patients with retinal disease and garner a significant part of this very large and growing market.

In parallel with our ocular research and clinical development activities, we have been conducting an extensive communication effort targeting ophthalmologists and optometrists. Palatin's scientists and collaborators have made presentations at most of the major medical meetings. We have been actively publishing our research. As a result of these efforts, Palatin is now beginning to be recognized as a company developing exciting new treatments for ocular diseases.

Moving on to our PL8177 oral formulation for ulcerative colitis, we are conducting the activities required to initiate a Phase II proof-of-concept study, which is targeted to start patient enrollment in the first half of 2022, with initial data readout in early second half 2022. This will be our first clinical study designed to evaluate the potential of a selective melanocortin-1 receptor agonist as a treatment for ulcerative colitis. The study will evaluate the safety and efficacy of oral PL8177. If positive, the results of the study will add to the validation of the melanocortin system as an innovative target for new drugs as well as support our efforts to license oral PL8177.

The market for drugs that treat various inflammatory bowel diseases is a multibillion dollar and there remains a large need for new, safe and effective treatment options to expand and advance the treatment of these patients. The emerging safety and efficacy profile of oral PL8177, if confirmed, would be a potentially major advance in the treatment of inflammatory bowel diseases, particularly in the pediatric patient population, where there remains an extremely high unmet medical need.

Finally, our natriuretic peptide program continued to advance PL-3994, which is a selective natriuretic peptide receptor A agonist, which is continuing to enroll patients in a Phase IIa clinical study in heart disease patients with preserved ejection fraction. The clinical study is being conducted in cooperation with 2 major academic medical centers and is supported by a grant from the American Heart Association. We anticipate preliminary data from this study should be available in early 2022.

Now this was just a small snapshot of some of the very exciting programs that we're doing at Palatin, and you can certainly find more and additional information on our website, www.palatin.com.

In closing, the past year has been transformative for Palatin. A little over a year ago with return of Vyleesi, we're a company with a single female health product in need of a major overhaul and some very early but interesting preclinical programs. As we began fiscal year 2022, we are a different company, advancing a new mechanism for treating a variety of inflammatory and autoimmune diseases based on drugs that modulate the melanocortin system with a focus on ocular diseases.

Our first ocular melanocortin-based drug, PL9643 will start a Phase III dry eye disease study before calendar year-end. And we are advancing PL9654 into the drug development process as a treatment for retinal diseases. Both of these innovative drugs have the potential to be significant players in the growing multibillion dollar markets. We are also planning to move a second front-of-the-eye disease program in the clinical trials in the first half of 2022. The foundation for this transformation is our unique understanding of the melanocortin system and our experience in the development and approval of drugs that modulate the system.

Over the past year, we've put in place the infrastructure, scientists and research activities that are advancing our understanding of how the melanocortin system works and the results are already helping to guide our clinical programs. We remain on track to start a Phase II proof-of-concept clinical study with our oral formulation of PL8177 in the first half of 2022, with data to follow later in the year.

Under Steve Wills' directions, our Vyleesi commercial activities have made significant progress. These changes are beginning to have a positive impact, increasing Vyleesi's prescriptions, revenue, subscription refills, and we anticipate realizing Vyleesi by calendar year-end. In closing, as we look forward to 2022, Steve and I are excited by the tremendous opportunity that we have to advance innovative drugs that will positively impact patients and build shareholder value.

We would like to thank you for listening to our call and your continued support. The call will now be opened for questions.

(Operator Instructions) We'll take our first question from Joe Pantginis with H.C. Wainwright.

So my question wants to focus on 8177 for ulcerative colitis, but I guess the basis also talks to your overall platform and mechanisms of action around the underlying melanocortin system. So I guess, first, can we start around the -- when you look at 8177, how can you compare it versus the current commercial treatments? And I think one of the next questions could be, since you have a differentiated mechanism of action, is there any potential for combined ability that could be beneficial for the competitive profile of the asset?

Sure. Thanks, Joe. Let's see how we can tackle this in a simple way. Certainly, I think key points here are, you mentioned differentiating mechanism of action. One of the things that we like about melanocortin system is that we're not blocking some pathway that's causing inflammation. We're fundamentally working to resolve the inflammatory process that's going on that's gotten out of control and to bring it back into control. And as part of that, you actually get promotion of tissue healing. One thing that we see with this mechanism is that not only we have the potential to generate safety -- efficacy, but it's quite safe.

We're not suppressing the immune system. So breakthrough infection, rare disease -- rare inflammatory autoimmune conditions or rare cancers really are not anticipated to occur with this mechanism. So it's really quite safe. So from a positioning standpoint, look, we certainly can't speak to efficacy other than we think it has tremendous potential, of course, but until we conduct clinical trials and begin to collect the data, we really can't answer that question in a lot of detail, but we do anticipate that we should see good efficacy based on the preclinical data.

We would anticipate it would probably be used before you move to the biologics. So ulcerative colitis and other inflammatory diseases today, there is an existing armamentarium that can be effective in a number of patients, but they have -- all have their safety conditions and concerns and tolerability concerns. And usually for many patients at some point, these options begin to stop working. So we would really anticipate us being somewhere in going from the generic treatments, maybe post steroids before you move on to a biologic. We're quite excited because of the safety -- and this is a peptide that's being given orally. There is no systemic absorption. We know that from the clinical studies that we've already done.

So it's quite safe and there remains a really, really high need in the pediatric population. And we've been dealing with some of the key opinion leaders there. They're quite excited about the potential that this drug works, we really do think that, in the pediatric population, which we intend to include those patients as soon as we have enough safety data to do that. We really think it could become potentially almost first-line treatment in these patients because of its safety and potential efficacy. So we're quite excited about what we really can do with this.

That's good color. And I guess it might be too early for this question, but obviously, I mean, you have a broader pipeline now, one asset that's about to enter Phase III and earlier assets that are percolating. So I guess at this point, what is your goals on the BD front? Are you looking to out-license or -- key potential territories? Or what are your overall goals right now from a high level?

Sure. I think one of the things that I tried to emphasize, and Steve and I have been -- and Steve started in his part is, look, we're not -- we have some very exciting programs. But it's also the advancement of that underlying science. What -- how does -- yes, we're focused in the ocular space, and we've been -- there's tremendous potential there with multiple opportunities as you see them beginning to emerge. As you know, 18 months ago, we didn't have an ocular program, and we had nothing in clinical trials and now we're getting ready to start the first one in Phase III. That's pretty good.

But the goal with like the ulcerative colitis, and we have another indication that we'll add on, we'll tell you about that and it's a non-ocular indication that we'll be adding on, we'll talk about that on the next call, is really to show the breadth of this mechanism. I mean, if we could put this treatment modality on the map, I mean you're now talking about a brand-new treatment with modality inflammatory and autoimmune diseases. I mean, that's going to help a lot of patients, and it's going to be tremendously valuable for our shareholders.

So that's really what the goal is on a longer term. For ulcerative colitis, we will not go forward -- we want to license that program. Dry eye disease and other ocular indications, if conditions are right, data is supported and conditions are right, we'd certainly like to retain those longer if we can. But I think if we hit it out of the park, like I think we will, I'm sure there's going to be a lot of interest and as much as we may want to keep those programs, I think I don't know that we'll have the opportunity to do that. I think then we'll have larger companies that will want them and will be willing to pay quite a lot for them.

We'll take our next question from John Newman with Canaccord.

Just curious if you could talk a little bit about the design of the MELODY-1 study. Specifically, if you have disclosed which signs and symptoms you would like to look at in that study?

We haven't yet, but we will. I mean they're not -- they'll be posted fairly soon. We'll be filing the protocol with clinicaltrials.gov. But they're pretty standard. So the design of the study is a pretty typical dry eye disease study. There's a running period where we obviously diagnose the patient and we qualify them that they meet all the entry criteria, so if they actually have moderate or severe disease. Patients -- studies in the United States in dry eye disease are generally conducted in what's called an adverse environment.

So we put them in a chamber that essentially dries up their eyes. It's a way that's used commonly to standardize the patient population so that we get a more standardized -- it was a highly variable disease, so we want to try and standardize that. And as you pointed out there, there are 2 types of things that we look at and they are signs and symptoms with signs being evidence of disease such as inflammation in the front of the eye, redness, tear film breakup time, tear film production, so on and so forth.

So for this study, we'll be looking at fluorescein staining of the cornea as well as lissamine green staining of the conjunctiva. So those will be -- we'll be looking at regional such as inferior and then total. So there are 3 staining endpoints that we'll be looking at, two will be primary and one will be secondary. The primary sign will be ocular discomfort. And then key secondaries will be, I think we have burning, I forgot the other one.

But there'll be part of ocular discomfort for the most part. And then we'll articulate those in the protocol when we file it, and we'll put that out in a press release when we state it. And so the other thing that we have in the study that...

One other question is, will you be looking at patients that have had experience with other agents for dry eye in the study or only patients that have not yet been treated with other products?

Yes. So they have to wash. We allow -- we don't have (inaudible) in the study or use it in the study, but as long as they're washed out of the study, they're allowed in as long as they're not currently on active treatment. They'll be allowed in the study.

And the other thing that we're talking about design. I think one of the things that we have that is (inaudible) is as you guys probably know, but maybe the audience possibly don't, dry eye disease is multifactorial, both on the region of the eye, the front of eye that can cause it as well as the types of patients, their age, underlying immune status and so on and so forth, which as a drug developer, we don't always like because that leads to a lot of variability. And one of the ways you combat that is by putting large numbers of patients in the studies.

But what we were able to agree with the agency is a little bit of a unique design, which is we've got a well-powered study based on the 240 patients. But as history will tell you, dry eye disease studies don't always come out the way you want. So in order to protect ourselves and allow ourselves to put in more patients if needed, we've actually built in what's called an interim data assessment. So we'll be analyzing the data from a statistical standpoint, looking at how the endpoints are doing.

It's looking at the power calculation that will allow us to determine if we need to put more patients in. The last thing we'd like -- we don't want to do is we just miss on 240, and if we have put 300 in the study, we'd have hit it. And the reason why that's important is because from an FDA regulatory perspective, we -- all we're looking for is a statistical difference in the endpoint from control versus active where there's no measurement or attribution of clinical benefit. The agency doesn't require that. All they look for is a statistical difference. So therefore, you want to really make sure you don't have an underpowered study. And if you need to put in 100 or 20 more patients to hit it, you want to be able to do that. So we think we're going to hit on the 240. But if we need to put in more, we've already worked that out with the agency, and we have a mechanism for doing that.

We'll take our next question from Michael Higgins with Ladenburg Thalmann.

Congrats on the continued progress with the pipeline. A couple of questions here. The first is a follow-up to John's question on the interim. Just trying to get a sense here, and it's early days, you've not started the trial yet. We don't have the clinical trials right up in front of us. But just trying to get some sense for what we will see from the interim look if at this point, subject to change, of course, but at this point, if you're looking for issuing a press release of yes, interim DSMB has suggested a go forward, increase in numbers would be highlighted at that point.

But really, the question is how much evidence would you provide at that point on the endpoints. Or do you just -- expect just to say, as I mentioned, continuing, if the number of patients to change or not?

So we will not be getting any data on what -- that you're hitting it, you're not hitting it. All that they will convey to us will be keep the study as is and go to your 240 and complete the study or they will tell us put 150 more patients in the study or put 50 more patients in the study or we recommend that you put 50 more patients in the study or 100 more patients in the study.

That's what -- so the press release will be, the interim analysis has occurred, we're on track, we will continue to go to 240 or we will go up a certain number of patients. But beyond that, they won't give us anything. And the reason for that is this is not a data analysis. This is really just a power calculation assessment. We don't want to take any statistical hits for multiplicity.

So it's purely to protect against the variability in these studies, which can be high. So we want to make sure we get enough patients in.

That makes sense. I just want to clarify that. And then I just want to follow up on your comments made on the 3994. Congrats that you're looking for data now early 2022. This has been a program that's been a huge upside, really been out of your hands given the AHA grants and waiting for sites to start and get going and all that.

So it's been kind of a slow roller. So now we've got data here within the next 6 months or so. Tell us what you're looking for? Any feedback that you've had so far on enrollment and how the study is progressing?

So enrollment has been fine. It's been slow. So the study is actually in 2 parts. The first part is collecting safety and hemodynamic data, and that's what we should have by the end of the year. The second part will then go on and look at actually more of a pharmacodynamic response. So we'll be looking at biopsy and other markers of improvement in cardiovascular function. So the first part is -- should be completed pretty soon. I think those patients have actually either been enrolled or identified and are being enrolled.

So as soon as they complete, we'll get the data from that, the first part, was the hemodynamic data, which actually is very important. It would be very nice to see the effects of 3994 on pulmonary capillary wedge pressure because that's really very important in these patients. And then as I said, the second part, we should get data around mid next year, which will be the markers of cardiovascular -- the improved markers of heart failure in these patients.

And keep in mind, these are preserved ejection fraction patients where the need is quite high. Now in addition to that, just as a little prelude to upcoming attractions, we'll have some more information out early next year on our overall natriuretic peptide program beyond 3994. We have some great things going on there, but the time does not allow for us to really get into that on this call.

Makes sense. I appreciate the additional fill in there. And then one last one here on Vyleesi. There's quite a gap, obviously, between the gross and the net sales. So looking ahead into '22, even in the remainder of this calendar year, how should we look for that gap to shrink? What's remaining from an accounting standpoint and also from a stocking standpoint before we see those -- that gap shrink?

I mean that's -- the objective and the target is not so much to shrink the gap, and what we're really targeting and spending our time and focus on is the market access, to increase the coverage, the net ASP, if you will. With our limited investment and to back it up, that investment was funded by the termination agreement, we did receive $16.3 million from AMAG with the regaining of the rights, albeit we did pick up some obligations regarding CMC.

But I don't anticipate a significant difference in the fourth quarter versus -- the fourth quarter being 12/31 and the third quarter, whether it's June 30 or 9/30. We will -- we are showing improvements right now. I mean, we look at things every day. And obviously, we have full vision into July and August. All the metrics, whether it's the refills, the prescriptions, and importantly, in our mind, we think this is the most significant metric, the market access, the scripts that are coming in, that are insured drug covered, which is my favorite number, which is Code 8. Because when I see the report, there's a Code 8, I know we have insured drug covered.

So we're spending the majority of our focus, not so much time per se, but just concentrating on that metric to increase it. So we're comfortable that we're showing the progress. And this is the type of progress that's needed when you're doing the relicense with the partners. They want to see that what is the data? Can they extrapolate? Can they get a comfort level that -- in their hands and in their hands, a right partner has the infrastructure. They have a team of market access people, obviously, much, much more significant sales infrastructure than what we have.

So we're comfortable with this measured and limited investment that we are showing progress. We have a very good WACC. We do have a number of subsidies from a copay standpoint, but we're seeing a lot of positive trends, albeit at the health care providers with new health care providers coming on, the scripts going up. And again, the market access is our primary metric, and that is improving. So hopefully, that was responsive. I know it was a bit long there, Michael.

That concludes today's question-and-answer session. Dr. Spana, at this time, I'll turn the conference back to you for any additional or closing remarks.

Well, I thank all of you for participating on the call and our analysts for their questions that help us to better illuminate what we're doing. We look forward to continue to -- Steve and I look forward to continuing to update you on what we're doing. I mean -- and I would really say that the staff here and the people here, even though we're working under pandemic conditions, there is a tremendous amount of excitement on what we can do. And we're really looking forward to 2022 and a number of maybe significant events that are going to occur with this company. So stay tuned, and you have a great day.

This concludes today's call. Thank you for your participation. You may now disconnect.