Palatin Technologies, Inc.

Hello, ladies and gentlemen, and welcome to Palatine's fourth quarter and fiscal year end 2021 operating results conference call. As a reminder, this conference is being recorded. Before we begin our remarks, I'd like to remind you that the statements made by Palatine 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 Security Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements and Palitin prospects. Now I'd like to turn today's call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palitin.

Thank you. Good morning and welcome to the Palitin Technologies fourth quarter in 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 a Romana-Corton-based anti-inflammatory, and autoimmune programs with an ocular focus. Regarding Vilisi, 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 healthcare provider awareness, patient engagement, and market access. with an objective of relicensing the U.S. rights to a committed women's healthcare company. And regarding progress, we are making progress. And this is with a limited and measured investment. For the quarter ended June 30th, 2021, gross product sales increased 28%. Net revenue increased 149%. And total prescriptions increased 17%. Over the quarter ended December 31st, 2020, which is Palatin's first full quarter of IDC operations. Refill rates increased over the quarters ended December 31st, 2020 and March 31st, 2021. Market access and reimbursement coverage also increased over the quarters ended December 31st, 2020 and March 31st, 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 by leasy and license and contract revenue related to by leasy. By leasy gross sales for the quarter and year-ended June 30th, 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-end of June 30th, 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-end of June 30th, 2021, and that was related to our license agreement with Kwandong for the Valisi rights to South Korea. And this compared to $117,989 for the year end of June 30th, 2020, related to our license agreement with AMAG Pharmaceuticals. Regarding operating expenses, for the quarter and year end of June 30th, 2021, were $13.9 million and $33.2 million, respectively, compared to $7.4 million and $23.7 million, respectively, for the same period 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 non-cash and non-recurring. The increase in operating expenses for 2021 was primarily due to the recognition of non-cash expenses on the by leasing license termination agreement, which I just mentioned. and also an increase in the selling general administrative expenses, which primarily were the commercial-related expenses for the VILECI program. Moving over to net loss and cash flows, Palatine'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 diluted common share, respectively. compared to a net loss of $7.3 million and $22.4 million, or $0.03 and $0.10 for 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 non-cash, non-recurring adjustment to the Vileci license termination agreement, and also some increases in the selling and G&A, primarily related to the commercial expenditures for Vileci. Cash position, I'm sorry, cash flows rather. Pallison's net cash used in operations for the quarter and year end of June 30th, 2021 was $8.5 million. And the main difference, we know 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 non-cash, non-recurring adjustment related to the Vilesi termination agreement. And we also had $22.6 million of net cash used in operations for the full fiscal year, June 30th, 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 cash position. As of June 30th, 2021, Paliton'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 30th, 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's going to go a bit more granular, but this does include the inflection points of data readout for our phase three dry eye disease trial and also data readout on our ulcerative colitis phase two 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 healthcare providers and partners. Before I get into discussing our clinical and development programs, I'd like to emphasize the following concerning our Valisi operating activities. Upon the return of Valisi last year, we undertook an extensive review of the Valisi commercial infrastructure and activities. The results clearly indicated that a substantial makeover was needed to support Vilisi commercialization and relicensing. This was not a trivial or short-term project. Under Steve's leadership, the Vilisi commercial infrastructure has been redone, and the changes that have been put in place have dramatically improved the patient experience, patient access, relationship with prescribers, and the profitability of Vilisi. We are now in a position to relicense Vilisi to a committed partner, ensuring the continued availability of Vilisi as a treatment option 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 non-ocular 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 two Phase III pivotal registration studies. The first PL964-3 Phase III dry eye disease study, called MELODY-1, will evaluate the safety and efficacy of PL964-3 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 an interim data assessment that 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. The three co-primary and three key secondary endpoints will be comprised of signs and symptoms of dry eye disease and were determined based on detailed analysis of the Phase II data. Melody I 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 PL964-3 dry ID study called MELODY-2 and an open-label safety study called MELODY-3. If successful, three MELODY PL964-3 dry ID studies will provide the safety and FC data required to file a new drug application with the FDA. The emerging profile of PL9-643 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 PL9-643 has the potential for substantial penetration into the multi-billion dollar dry eye disease market. We believe that PL9-643 and other reminocortin 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 this 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. And preclinical models of retinal injury and diabetic retinopathy Treatment with our peptide PL9654 in melanocortin aconis 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 sustained release of PL9654 that will 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 treatments, Research and clinical development activities, we have been conducting an extensive communication effort targeting ophthalmologists and optometrists. Palatin scientists and collaborators have made presentations at most of the major medical meetings, and 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 multi-billion 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 naturally peptide program continued to advance PLN3994, which is a selective naturally peptide receptor A agonist. It's continuing to enroll patients in a phase 2A clinical study in heart disease patients with preserved ejection fraction. The clinical study is being conducted in cooperation with two 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 the return of Alesi, we were 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, We'll start a phase three 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 multi-billion dollar markets. We are also planning to move a second front of the eye disease program into 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 Lanocortin 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's will's directions, our Valisee commercial activities have made significant progress. These changes are beginning to have a positive impact, increasing Valisee's prescriptions, revenue, prescription refills, and we anticipate relicings of Valisee 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 open for questions.

Thank you. If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star 1 to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal for questions.

We'll take our first question from Joe Pantagenis with HC Wainwright.

Hey guys, thanks for taking the question. So, you know, 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, you know, 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, you know, since you have a differentiated mechanism of action, is there any potential for combinability 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. You know, One of the things that we like about the melanocortin system is that, you know, we're not blocking some, you know, 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 do we have the potential to generate safety, efficacy, but it's quite safe. You know, 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, you know, 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, you know, ulcerative colitis and other inflammatory diseases today, there isn't an existing armamentarium that can be effective in a number of patients, but they all have their safety conditions and concerns and tolerability concerns. And usually for many patients at some point, you know, 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. Keep in mind, 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. We've been dealing with some of the key opinion leaders there, They're quite excited about the potential. If 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, Collar. Thanks for that. 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 three, and earlier assets that are percolating. So I guess, you know, at this point, what is your, you know, your goals on the BD front? Are you looking to out-license or, you know, keep potential territories or, you know, what are your overall goals right now from a high level?

Sure. I think, you know, one of the things that I tried to emphasize, and Steve and I have been, and Steve started in his part, is, you know, look, we're not We have some very exciting programs, but it's also the advancement of that underlying science. Yes, we're focused in the ocular space, and we think 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 three. That's pretty good. But the goal would be ulcerative colitis, and we have another indication that we'll add on. We'll tell you about that. 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 modality in 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 in the longer term. For ulcerative colitis, we want to license that program. Dry eye disease and other oxygen indications, if conditions are right, data supports it and conditions are right, we would 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 re-keep those programs, I don't know that we'll have the opportunity to do that. I think there will be larger companies that will want them and will be willing to pay quite a lot for them.

Got it, got it. Thanks for all that, and good luck on the new fiscal year.

Thank you, sir. We'll take our next question from John Newman with Ken Accord.

Hi, guys. Thanks for taking my question. Just curious if you could talk a little bit about the design of the Melody One study, specifically if you have disclosed which signs and symptoms you would like to look at in that study? Thanks.

We haven't yet, but we will. I mean, 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 run-in period where we obviously diagnose the patient and we qualify them that they meet all the entry criteria, so if they actually have moderate to severe disease. Patients, studies in the United States in dry, these are generally conducted in what's called an adverse environment, so we put them in a chamber that essentially dries out their eyes. And 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 are two 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 the study, we'll be looking at fluorescein staining of the cornea as well as lecithin green staining of the conjunctiva. So those will be looking at regionals such as inferior and then total. So there are three 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, what do we have, burning? I forget the other one. But they'll be part of ocular discomfort for the most part. And we'll articulate those in the protocol when we file it, and we'll put that out in the 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?

Yeah, so they have to wash. We don't have artificial tears 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. We're talking about design. I think one of the things that we have that is a little unique is, as you guys probably know, but maybe the audience, the other parts of you guys don't, Dry eye disease is multifactorial, both on the region of the eye, the front of the 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, you know, 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 won't be analyzing the data, you know, from a statistical endpoint looking at, you know, 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, you know, we don't want to do is, you know, we just missed on 240, and if we had put 300 in the study, we would have hit it. And the reason why that's important is because from an FDA regulatory perspective, all we're looking for is a statistical difference in the endpoint from control versus active. 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 in the two 40, 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.

Okay, great. Thanks very much. We'll take our next question from Michael Higgins with Leidenberg.

All right, guys, thanks for taking the questions. Uh, congrats continued progress with the pipeline. Um, a couple of questions here. The first is a follow up from John's question, um, on the interim. Just trying to get a sense here in the 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 is suggested to 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 and the number of patients to change or not?

We will not be getting any data on that you're hitting it or 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. We recommend that you put 50 more patients in the study or 100 more patients in the study. So the press release would be the interim analysis 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's a, that makes sense thing. Just want to clarify that. Um, and then just want to follow up one of your comments made, um, and, uh, three, nine, nine, four congrats, uh, that you're looking for data now, early 2022. Uh, this has been a program that's been a huge upside, but really been out of your hands given the AHA grant 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 six months or so, uh, tell us what you're looking for. any feedback that you've had so far on enrollment and how the study's progressing?

So enrollment's been fine. It's been slow. So the study's actually in two 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 form of dynamic response. So we'll be looking at biopsy and other markers of hemodynamic improvement in cardiovascular function. So the first part 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 the first part, which will be hemodynamic data, which is actually very important. It would be very nice to see the effects of 3994 on pulmonary cavity wedge pressure because that's really very important in these patients. And as I said, the second part, we should get data around mid-next year, which will be the markers of cardiovascular, we improve 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 time does not allow for us to really get into that on this call.

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

I mean, 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 1231 and the third quarter whether it's June 30th or 930. We are showing improvements right now. I mean, we look at things every day, and obviously, you know, 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, you know, my favorite number, which is code eight, because, When I see the report and 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, you know, what is the data? Can they extrapolate? Can they get a comfort level in their hands? And in their hands, you know, 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 WAC. You know, we do have a number of subsidies from a co-pay standpoint, but we're seeing a lot of positive trends, albeit at the health care providers. with new healthcare 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.

No, no worries. That's great. I appreciate the feedback, guys, and congrats again.

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, thank all of you for participating on the call and our analysts for their, their questions that help us to better illuminate what we're doing. Look forward to continue to Steven. I look forward to continuing to update you on what we're doing. Uh, I mean, and I would really say that the, you know, the staff here and the people here, uh, even though we're working under pandemic conditions, there is a tremendous amount of excitement on what we can do. And, uh, we're really looking forward to 2022 and, 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.