TherapeuticsMD Inc (TXMD) 2014 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to TherapeuticsMD first quarter 2014 results call. (Operator instructions.) As a reminder, this conference is being recorded today, Monday, May 5th, 2014.

I would now like to turn the conference over to Lisa Wilson, Investor Relations for TherapeuticsMD. Please go ahead.

Thank you for joining us this afternoon for TherapeuticsMD's first quarter 2014 financial results conference call. I'm Lisa Wilson, Investor Relations for TherapeuticsMD. With me today are Rob Finizio, cofounder and CEO, and Dan Cartwright, CFO of TherapeuticsMD.

By now you should have received a copy of the company's press release issued today after the close of market. If you have not received it, you may access it through the company's website at Therapeuticsmd.com in the Investor Relations section.

Before we get started, I would like to remind everyone that any forward-looking statements made during the call are protected under the safe harbor of the Private Securities Litigation and Reform Act. Such forward-looking statements are based upon current expectations, and there can be no assurance that the results contemplated in these statements will be realized.

Actual results may differ materially from such statements due to a number of factors and risks, some of which are identified in our press release and our annual and quarterly reports filed with the SEC.

These forward-looking statements are based on information available to TherapeuticsMD today, and the company assumes no obligation to update statements as circumstances change.

A telephone replay of this call will be available shortly after completion through May 26th. You'll find the dial-in information in today's press release. The archived webcast will be available online for one year at Therapeuticsmd.com.

For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 5th, 2014. Since then, TherapeuticsMD may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings.

With that, I'll turn the call over the Dan Cartwright.

Thanks, Lisa, and good afternoon, everyone.

For the three months ended March 31, 2014, net revenue was $2.8 million compared with net revenue of $1.5 million for the three months ended March 31, 2013.

This increase was directly attributable to a combination of increases in the number of physicians writing prescriptions for our products, the productivity of our sales force, and an increase in the average net sales price of our products.

Cost of goods sold increased by $450,000, or 118%, for the first quarter of 2014 compared with the prior year quarter.

Research and development expenses increased to $5.9 million for the first quarter of 2014 compared with $1.6 million for the first quarter of 2013, due to costs incurred in connection with the development of our hormone replacement therapy drug candidates.

Sales, general, and administrative expenses increased to $5.5 million for the first quarter of 2014 compared with $4.5 million for the first quarter of 2013. As a result, our operating loss was $9 million for the first quarter of 2014 compared with $4.9 million for the first quarter of 2013.

Other non-operating expenses decreased by $1.2 million for the first quarter of 2014 compared with the same quarter in 2013. This increase was primarily a result of a decrease in interest expense of approximately $1.2 million.

As a result, net loss for the first quarter of 2014 was $9.2 million, or $0.06 per basic and diluted share, compared with a net loss of $6.4 million, or $0.06 per basic and diluted share, for the first quarter of 2013.

Cash and cash equivalents were $45.4 million at March 31st, 2014 compared with $54.2 million at December 31, 2013.

In March 2014, we successfully completed an offering in which selling shareholders sold shares. The company did not sell any shares nor receive any proceeds.

With that, I'll turn the call over to Rob Finizio to discuss the business in greater detail.

Thanks, Dan. Good evening, everyone.

This has been a busy and productive quarter for TXMD. My goal in today's call is to give a concise update on the positive strides we've made so far this year and put our significant opportunities into perspective.

We're excited about the progress of the business. We remain focused on executing our strategy to successfully advance our product candidates and build shareholder value.

We're a women's based healthcare company developing a pipeline that includes two potential blockbuster drugs. Our model leverages 505(b)(2) pathway that is clearly defined and typically affords a faster path to market with fewer regulatory hurdles as compared to new chemical entity drug development.

Our two largest opportunities and potential blockbuster drugs are combination estradiol and progesterone for treatment of vasomotor symptoms in menopausal women, and our estradiol VagiCap for VVA.

We are developing these investigational products in accordance with the FDA draft guidance for the treatment of moderate to severe vasomotor symptoms associated with menopause and VVA that was published in 2003 and is available on the FDA website.

I'd like to start by discussing our investigational oral combination estradiol and progesterone product and its considerable potential in an estimated multibillion dollar market.

Currently there's little to no promotion of FDA approved combination drugs which use a variety of synthetic progestins and not progesterone. These FDA approved synthetic drugs comprised about 25% of the total oral combination sales in the US last year.

The remaining 75%, or an estimated $1.5 billion, was from sales of compounded estradiol and progesterone, which is predominant despite the risks related to compounding. Furthermore, the risks associated with compounding of estrogen, estradiol, and progesterone are detailed on the FDA's website, calling attention to the significant public health issue.

The compounded hormone segment has grown significantly since the Women's Health Initiative study, yet there's been no FDA approved combination of estradiol and progesterone available despite this high demand. TXMD has significant opportunities to meet this market demand.

Underlying this opportunity is the positive impact from recent legislative changes that directly affects compounding pharmacies and which we believe is also highly favorable for TXMD. The Drug Quality and Security Act, which was signed into law on November 27th, 2013, clarifies the FDA's legal authority to enforce this law to protect public health.

In less than four months since the law was passed, the FDA has issued eight Federal Register notices with unprecedented speed to expedite implementation of the new laws, Compounding and Quality Drug Act. The FDA's enforcement actions to date have included the issuance of warning letters through a risk-based approach in accordance with the recently issued draft compliance guidance.

Under the new law, the previously unregulated compounding industry will no longer be able to make what is considered an essential copy of an FDA approved drug and is expected to come under increased oversight and pressure, the greater transparency on the risks associated with compounding complicated dosage forms, including combination solid oral dosage forms, that requires a high degree of content uniformity from one dose to the next.

More specifics will unfold over the next two to three quarters, but the FDA has already announced a heavy schedule for the Pharmacy Compounding Advisory Committee, including up to six meetings annually. It's also likely to begin deliberations around the statutory requirement to create a list of drugs, due to their inherent complexity, should not be compounded, and the likelihood of adversely affecting safety and efficacy.

In this increasingly regulated environment, TXMD believes a first mover advantage is critical to gaining a dominant market position. Ours is the only Phase III vasomotor trial currently underway in the US.

We are not aware of any competitor at any stage of development in the US or abroad that is developing estradiol and progesterone in combination. Therefore, we believe we are ideally positioned to execute and capitalize on this opportunity, assuming we can obtain FDA approval.

In anticipation, TXMD is actively monitoring most large insurance plans' status and strategy for reimbursement in this class of therapy. We're very happy to report that this segment remains as an unmanaged class.

The importance of being an unmanaged class is insurance companies reimburse for newly added branded drugs as tier three without the product having to go through P&T review.

Moving on to our corporate development strategy, to address this large and growing market with our oral investigational estradiol and progesterone combination product candidate, we are following the 505(b)(2) regulatory pathway, which requires only one Phase III clinical trial to establish efficacy.

This is because estradiol and progesterone are very well known molecules with clear therapeutic thresholds. Our strategy is to leverage this knowledge along with our novel solubilized lipid-based technology to capitalize on the opportunity in this very attractive market and deliver value for shareholders.

Now turning to our Phase III REPLENISH trial for the treatment of vasomotor symptoms due to menopause, this trial continues to move forward with great progress. Enrollment is strong, patient retention is very positive, and I'm pleased to report that we remain on track to complete enrollment of the REPLENISH trial this fall, which is in line with our previously stated timeline.

Let me summarize the drug candidate opportunity here. This is an extremely large market with significant potential to grow, given new position statements by medical societies and our aging population in the US.

These well known molecules are understood and well documented with a clear therapeutic efficacy threshold. The FDA offers a clear draft guidance for clinical evaluation of estradiol and progesterone therapy for vasomotor symptoms.

We have a strong hormonal development team directed by Dr. Sebastian Mirkin, the previous Global Lead of Women's Health Clinical Research and Development at Pfizer, who led the development of the recently approved hormone combination called Duavee.

The Drug Quality and Security Act has created a significant first mover opportunity which we look to capitalize on, assuming FDA approval. This market exists, the demand is clear, and we remain poised to address this important opportunity and meet the needs of menopausal women, assuming we secure FDA approval.

Moving on to vulvar/vaginal atrophy, another significant market opportunity we're pursuing, also known as VVA. In 2008, the sales of estrogen products for VVA were $500 million without any generic alternatives.

Fast forward to 2013. Annual sales of branded products for VVA were up to an impressive $1.1 billion, still with no generics. And this rate of growth is expected to increase as the baby boomers age moving forward.

Estrogen therapy for VVA has been off the development radar of large pharma with the focus instead on non-hormonal approaches like Osphena. As a result, recent estrogenic products' approval in the VVA market was back in the 1990s.

The current approved estrogenic products do not have any Orange Book listed patents but generics have been unable to penetrate this market, which is very unusual in pharma and in women's healthcare markets.

Given new bullish position statements for low dose estrogen therapies to treat VVA by medical societies and our aging population, we believe there's a significant opportunity for innovation of estrogenic solutions for VVA, and that TXMD is in the right place at the right time.

Most if not all insurance plans continue to keep the VVA therapeutic category as an unmanaged class. The importance of being an unmanaged class is insurance companies reimburse for newly added branded drugs as tier three, again, without the product having to go through P&T review, just like I described earlier for estradiol and progesterone.

Localized estrogen therapy for VVA symptoms is in addition -- is the front line treatment option. We will continue to monitor payor status on all classes that may impact our investigational drugs, and we'll let you know if anything changes.

Our goal is to bring to market an innovative VVA product that features a positive, qualitative user experience for menopausal women. We developed our Phase III protocol following the FDA's draft guidance for clinical development of estrogenic drugs for VVA.

The clinical trial is designed to assess the capability of our investigational estradiol product called the VagiCap, which leverages our solubilized lipid-based technology to achieve new lower and more effective doses that could potentially reduce or eliminate systemic exposure of estradiol.

We intend to have three active arms consisting of our 25 microgram and 10 microgram doses and a new 4 microgram dose, as well as a placebo arm. Another important goal, if we succeed in establishing clinical efficacy, is our new therapeutic approach would enable a very strong IP position.

Let's discuss the trial. We've submitted our briefing book to the FDA and look forward to meeting with the agency to secure agreement on our Phase III trial protocol.

We expect to start our Phase III trial protocol for VVA in Q3 of this year. The expected size of the trial will be approximately 170 patients in each active arm, and there's three active arms, and 100 in the placebo arm for a total of 610 women.

Our goal is to have a total of 30 sites to expedite enrollment. To put the enrollment portion of this trial into perspective, in our previous Phase II trial where we studied our 10 microgram dose, we were able to enroll 50 patients at a single site in just six weeks.

Such rapid enrollment is due, we feel, to a number of factors -- the high cost of current branded VVA products and the absence of generic options, and lastly the fact that 50% of all postmenopausal women have this very uncomfortable condition, creating a favorable environment for trial recruitment.

To be conservative, we have built in nine months for recruiting, and we expect to have a top line data read in Q3 of 2015 for our VVA products. If successful and approved by the FDA, the 4 microgram dose would be a new lower dose of estradiol than any other approved product on the market today.

The VVA opportunity, much like the estradiol and progesterone combo opportunity, is a great fit for TXMD's core development metrics. Those metrics are there are no generics on the market for VVA. We cannot find any Orange Book listed patents for the branded drugs in the VVA market on the market today. There have been no new VVA estrogenic products introduced for a decade or two. The VVA market is growing at 20% plus a year since 2008, and ASD Analytics estimates that this market will grow to $3.1 billion by 2019.

So, let's summarize the common themes from a strategic development perspective amongst these two drugs. Our investigational oral estradiol plus progesterone and estradiol VagiCap for VVA are both well known molecules with clear therapeutic efficacy thresholds.

Both drugs fall under the FDA's draft guidance for 505(b)(2) filings, setting forth a clear clinical pathway for estrogen products to treat vasomotor symptoms of menopause and VVA. Both are significant and underserved markets, each presenting key growth opportunities for TXMD.

As I've said before, we have one of the top hormonal development teams in the industry. I want to highlight that, in addition to his work on Duavee, Dr. Sebastian Mirkin has led five successful VVA trials including the last estrogen product approved, which is Premarin low dose vaginal cream.

In closing, there are a number of bullish activities going on in this space. Recently NAMS changed guidance to favor low dose estrogen therapy. In addition to that, large pharma is increasingly spending on TV and printed ad campaigns for Premarin low dose vaginal cream and non-hormonal Osphena, which help to drive awareness and expand the market.

We're encouraged by these factors, which lead us to believe that our pipeline offers a platform for a complete women's health franchise.

Moving on to TX002-HR, our investigational progesterone candidate, it's being studies in a Phase III trial for the potential treatment of secondary amenorrhea. It's called the SPRY trial.

This trial continues to face recruiting challenges. To remedy these recruiting challenges, we are meeting with the FDA in early June to discuss potential changes to our inclusion and our exclusion criteria. We'll provide an update as soon as we have a clear path forward.

Looking further along our pipeline, this month we expect to begin early studies focused on topical progesterone alone and topical progesterone in combination with estradiol. If successful, we'll move into full blown Phase I studies shortly thereafter.

Transdermal administration of progesterone presents a significant advancement in the science of women's health and hormones, as well as a solid IP opportunity and global product diversification strategy for TXMD. We cannot find a single FDA approved progesterone transdermal product in any major market.

To understand why this route of administration is important, when a hormone is taken orally it moves from the stomach to the liver before it reaches the rest of the body. The liver metabolizes the hormone, reducing its bioavailability and causing various side effects.

For oral estrogenic compounds, the clotting activity is primarily due to this first pass side effect. When hormones are delivered transdermally, they eliminate the first pass side effect profile. Therefore, transdermal hormone delivery presents an important route of administration with implications for improved safety.

We believe our solubilized technology will enable us to successfully deliver progesterone alone and with estradiol transdermally. Pending positive outcomes of our early studies, we intend to partner for the development and commercialization of our transdermal product line.

We view a potential partnership as an efficient way to get another product to market without distracting us from our focus on our current Phase III products, as well as a strong source of potential non-dilutive funding.

We are currently in early discussions with multiple large pharmaceutical companies regarding potential co-development and co-promotion agreements related to our transdermal programs. We will enter into strategic alliances with the right partner only with the appropriate terms that we believe will maximize the value for our shareholders.

While we understand the potential value to big pharma in our VVA and estradiol and progesterone oral programs, we currently do not have any plans to partner our investigational VVA or oral E plus P candidates, and we look to hold all rights to both drugs worldwide.

Moving on to IP, the ongoing dialogue between TXMD and the patent office remains positive. In Q1 of 2014, we filed four additional patent applications, bringing total applications filed and issued up to 33. 24 of these are US utility or foreign applications. We're planning on additional utility filings covering our combination, VVA, and solo progesterone candidates in Q2.

We'll continue to execute our comprehensive global IP strategy going forward, including planned IP filings surrounding our pipeline technologies at critical milestones.

Finally, we're pleased to welcome a very strong group of new institutional investors to TXMD this quarter through a non-dilutive secondary offering. This offering was three times over subscribed and enabled us to place shares for which the locked up period expired.

We are working hard to build and strengthen our sell side relationships with current and new analysts. We hope these efforts will result in expanded analyst coverage in the near future.

Moving on, everyone please mark your calendars for our first analyst day, which we will host in New York City on June 16th. Again, our first analyst day which we'll host in New York City on June 16th. Further details will be forthcoming, but our goal is to bring in experts and key opinion leaders to talk about TXMD's opportunities in the hormonal and VVA markets.

These include a previous FDA director who has worked on approvals of other oral combination products while at the agency, and can give insight into current regulatory challenges.

Another set of thought leaders will discuss the new compounding law and its impact, and market research analysts will discuss specifics of the size and breadth of the compounding market. In addition, we can expect key insights from TXMD management and Board of Directors, including Tommy Thompson and Sebastian Mirkin.

With that, operator, please open the call for questions.

Thank you very much, sir. (Operator instructions.) Annabel Samimy, Stifel.

Hi. Thanks for taking my question. Just a couple on the estrogen product first. You had a release of the rabbit data that showed that it was a nonirritant, the VagiCap was a nonirritant. How important is this in terms of a differentiating feature? Is this something that's really critical? And is it a factor of just the formulation, or is it a factor of the dose?

Hey, Annabel. It's good of hear from you. A great question, too.

So, the rabbit irritation study was a checkbox. It was not very clinically significant. But, from a regulatory standpoint, if you failed it you would go back to Phase I. So, given the potential development timeline implications, our regulatory counsel advised us to make that public.

And then on the initiation of the trial for VagiCap, that's been pushed off to the third quarter now as opposed to the second quarter because you're trying to add the 4 microgram dose.

Absolutely. Annabel, another great question, and I'm glad you brought it up. So, yes, we're really excited.

So, on our last call, we decided to announce that we added the 4 microgram dose. We see a tremendous upside in this market if we can get that approved, and that is our intent.

We basically lost about 30 days is what we see at this point. So, we pushed it from late Q2 into Q3. We are going to meet with the FDA here, gain agreement on our Phase III protocol, and then start that. Our current anticipated timeline to start that is Q3.

Have you had any preliminary discussions with FDA? You're not talking until that point where you have the meeting?

Well, we did have a good dialogue with the FDA, and I have to be limited what I say here, on our previous dialogue when we were going to go down the 10 and 25 microgram dose. So, we have a pretty good set of what I call guardrails on how this has to work.

And given management's experience on the previous drugs that they've worked on that have been approved, we think we have a relatively straightforward path here that we just want -- of course, before you start any of these trials, you want to have full FDA cooperation that you are meeting the standard that the FDA puts forward. So, that's our goal.

And just wanted to clarify. You said you're going to enroll 60 sites, correct?

We currently have approximately 70 sites up and going with the combination. The idea for the VVA product, to expedite enrollment, is to use about 30 of those sites that are already up and going.

So, one of the things I wanted to touch on -- and Annabel, I'm glad you brought that up, because a lot of people ask me these questions. It's great to put it out there for everybody to listen to -- is the VVA market is very, very unique, since the products are relatively expensive, $200 approximately for about a 30 day use here of a VVA product that's approved on the market today, and the lack of generics and the fact half of all women have this condition and it's chronic.

So, when they get treatment, if they go off of treatment, the symptoms come back and they come back worse. So, a lot of women will be on treatment for the rest of their life.

It was very positively surprising in our Phase II trial that with a single site, in six weeks we were able to enroll 50 patients and screen over 200. I mean just very impressive.

So, if you look at our total of 600 for Phase III, and we're going to leverage approximately 30 sites, we think that we can enroll this pretty quick. And we're forecasting a very conservative one year timeline for this trial, which means there'd be a top line data read, in a conservative fashion, of Q3 2015.

Right. I guess I was questioning that conservative stance, given that you had only one site in Phase II and you've got 30 times as much now. And you had 50 sites -- I mean 50 patients enrolled in six weeks. So, why such a conservative stance, because you're not going to have any kind of data release for quite a while, if that's the stance you're taking, right? So, the catalyst is what I'm trying to -- data catalyst is what I'm fishing for here.

My goal is to under promise and over deliver. It would be really exciting if I could enroll it quick and have a last patient in announcement, because it's only a 90 day trial. The efficacy portion of this trial is clearly 12 weeks, right?

So, my goal is to try to deliver that for you but, at the same time, give a very conservative outlook here. And hopefully I can impress you. That's my goal.

(Operator instructions.) Ed Nash, Cowen and Company.

Great. Thanks for taking my question. With regard to the 001-HR trial, so what are the chances that -- or actually, I guess, the drug. What are the chances of this having a standard boxed warning like the other combination therapies, or does the agency actually recognize a difference between the progestin and a bioidentical progesterone?

Ed, that's a great question. And thanks for dialing in today, by the way. I know you guys are really busy.

So, that brings up a number of very unique opportunities here for TXMD and for our shareholders on the phone here. So, the first piece, black box. All systemic estrogenic products get a black box.

As you know, we work with Dan Shames, who was running this department at the FDA when the black box inclusion criteria and the actual black box warning was created. And we understand through him pretty well what's going on here.

So, the black box states to start with the lowest effective dose possible. As you know, we are studying two new lower effective doses than anything on the market today. So, in the worst case scenario, we would have that as a potential sales aid to support our sales reps detailing to physicians.

In addition to that, we do believe that we will have a black box like all other therapies. But, with this class of medication, the black box warning is a deterrent for some women for the FDA approved drugs, and for others it doesn't bother them.

But, the compounding market is three times larger at a minimum than the FDA approved market. And with that being said, with the Drug Quality and Security Act being in place, that $1.5 billion of FDA compounded estradiol and progesterone, we should be able to establish a very, very strong market share if we can achieve approval. And that's the goal.

So, our point here is the market's built. It's huge. And if we get approved under the Drug Quality and Security Act, compounders would no longer be able to compound an essential copy of our estradiol and progesterone. So, regardless of the black box, we think there's a significant uptick here for us and a very, very unique opportunity for TXMD shareholders.

Does that answer your question?

Great. Yes, that was helpful. Thanks. And then, with regard to VVA, the actual inclusion of the 4 microgram dose, is there any evidence, clinical evidence, to suggest that this will be successful at this low of a dose, or is this just kind of an opportunistic shot in the hopes that we could get a lower dose, which is obviously what we always are trying to do in hormonal therapy?

Great question, Ed. So, I have to speak to this as something we are trying to achieve, just to be clear for the record.

So, if you look at the Phase II studies we did with our 10 microgram dose, at the end of two weeks we were able to have pretty strong statistical separation for the parabasal cells, the superficial cells, and the vaginal pH. It was very strong in just two weeks of therapy.

In fact, if that trend continues, it'll be a shoo-in. When you add that to our PKs or our 10 microgram dose, if actually put head to head against the Vagifem product, you can see the systemic PK difference, all right?

So, from our perspective, we feel as though we have a good shot if you take those two facts into consideration, that the 4 microgram dose has a good shot at being clinically effective at the end of the 12 week study.

Now, we have to prove it. Everything I'm saying here is caveated with until you prove it to the FDA it doesn't count. But, we think we have a shot at doing it.

Nathan Cali, Noble Financial.

Hey, guys, good afternoon. Thanks for taking the questions. Just one follow up question to the VVA product on the 4 meg dose. If you do achieve and you do get approval for that dosage form, there had been discussions whether there would be levels of circulating estradiol. And the lower levels of that, the better product you have, obviously. Would there be any labeling around that if you were to get the 4 meg dose comparable to Vagifem?

Nathan, thanks for joining, and I appreciate the question. So, as far as the 4 microgram dose goes, we'll do a study with the 4 microgram against placebo to see if there is any increase in systemic estrogen, right?

The black box inclusion criteria, from what I have learned from Dan Shames, is included because of the systemic exposure. So, I can only give you Dan's opinion, and he does believe we would have a good argument with the FDA if the 4 microgram dose does not show any systemic exposure. So, we're really excited to try to achieve it.

But, one other thing that I think we would like to call out here that I'm not sure if people have seen. The North American Menopause Society is actually working with the FDA and has publicly announced, if you go to their website -- and that's Nams.org, the North American Menopause Society -- that they feel that the black box warning is a deterrent for women seeking therapy for this class of drugs, and that it's such a predominant issue with such a stigma that they would really like to see the black box removed for all products.

So, given that's the flavor of the leading hormonal regulatory body or medical society in the US that's actually already going to the FDA, it only helps our case, especially if we can establish no systemic exposure, which is one of our development goals.

So, I hope that answers your question, Nathan. It's a good one. I get it a lot.

Thanks. And then, what's the duration of dosing in the Phase III?

The duration is for the first two weeks, it's a daily dose, and then it's taken two times a week for the remaining 10 weeks. It's a 12 week study.

Thanks a lot. That's all the questions for today.

Nathan, thanks again for the time.

(Operator instructions.) Joe Russi, Silber Bennett.

Hi. Thank you for taking my call. I admit I got in the middle of a conference call with another line. Did you guys discuss the recent stock sale?

We touched on it. We touched on it with the new group of shareholders. That's about it.

Okay. Well, let me ask you this. I mean, if you sell it at $7.10 and the stock's drifting down in the $3.00s, are they going to be interested in buying stock back?

What do you mean by that?

Well, they sold the stock to somebody else, and now the stock has dropped 50% at least. Why wouldn't they want to be interested in buying the stock back if we have so much good things going on?

I would think that would trigger the short swing rule if they were considered insiders, but I don't know. I can't speak for other shareholders.

Remember the company was not included. We didn't sell shares, so it would be just giving opinions of various people. So, I wish I could give you more color on that, but I don't have any.

All right. I appreciate it. Thanks for your time.

You got it.

(Operator instructions.) And all, there are no further questions at this time. I'll turn the presentation back to you. Thank you.

Thanks, operator.

Thanks again, everyone, and we look forward to what the next few quarters will bring. And we believe we have successfully positioned the company to benefit from an increasingly receptive regulatory environment with our high quality, safe, and effective products.

Thank you for joining us, and we look forward to seeing you in June.

Ladies and gentlemen, that does conclude the call for today. We thank you very much for your participation and ask that you please disconnect. Thank you once again for attending. Have a good day.