TherapeuticsMD, Inc. Q4 FY2020 Earnings Call

Good morning, everyone. Thank you for being here for TherapeuticsMD's Fourth Quarter 2020 Financial Results Conference Call. I will now hand the call over to TherapeuticsMD's Vice President of Investor Relations, Nichol Ochsner. Nichol.

Thank you. Good morning, everyone. Thank you for joining today to discuss our fourth quarter financial results and business update. This morning, TherapeuticsMD issued a press release, announcing our fourth quarter financial results. The press release is available on the company's website, therapeuticsmd.com, in the Investors & Media section. On today's call from TherapeuticsMD are Chief Executive Officer, Robert Finizio; Chief Financial Officer, James D'Arecca; Chief Commercial Officer, Dawn Halkuff; and Chief Strategy and Performance Officer, Mitchell Krassan. I would like to remind everyone that certain statements made during this conference call may contain forward-looking statements. Such forward-looking statements are based upon current expectations, and there can be no assurances 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, quarterly, and other 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. An audio recording and webcast replay for today's conference call will also be available online in the Investors & Media section of the company's website. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded March 02, 2021. With that, I'll turn the call over to TherapeuticsMD CEO, Rob Finizio.

Good morning. On today's call, we will review our fourth quarter and full year performance, progress made on strengthening our capital structure, and our commercial plans. We delivered a strong year and a strong quarter with record total net product revenue for our company. We successfully executed on multiple priorities demonstrating operational agility while maintaining a strict focus on commercial execution and financial discipline. We've lowered our operating expenses, updated our net revenue covenants for the remainder of the term of our loan, and strengthened our balance sheet through equity capital raises as we reduce our debt. Before I turn the call over to James to give you the details on the transformative progress we've recently achieved, I'd also like to mention that the vitaCare divestiture process is still moving forward with multiple interested parties. I will now turn the call over to James.

Thanks, Rob. Before reviewing our fourth quarter financial results, I would like to discuss our balance sheet and elaborate on updates with our lender. Turn to Slide 5. We have strengthened the balance sheet by raising over $180 million in net proceeds since last November, which after the recently completed offering earlier this month brought our cash balance to over $200 million. Our strong cash position has enabled us to work with our lender to reduce our future covenants for the remaining life of the loan, gain their consent on the terms on which we can divest vitaCare prescription services, and pay down $50 million of debt by the end of March. Paying down debt allows us to reduce interest expense as we move forward and we believe it will also facilitate the refinancing of our remaining debt at more favorable terms in the future that will reflect the advancing stage of commercialization of our key products. As Rob mentioned, we have agreed with our lender to update our aggregate revenue covenants for ANNOVERA, IMVEXXY, and BIJUVA. Our first quarter revenue covenant is now $17 million, second quarter is now $20 million, third quarter is $23 million, fourth quarter is $26.5 million, and first quarter 2022 is $30 million. After that time, it increases $5 million per quarter. While in our formal guidance, we believe these revenue covenants have been set at minimum levels that are sufficiently below our revenue expectations given the current state of the COVID-19 pandemic and provide sufficient headroom to avoid further adjustment. We believe our de-leveraging along with our updated net revenue covenant is transformational, and we are now poised to focus solely on executing our commercialization efforts. Let's move on to a review of our financial results and key metrics from the fourth quarter. Turning to Slide 7, our overall net revenue for the fourth quarter increased to $22.6 million, which satisfied our fourth quarter revenue covenant. This was a 30% increase in product net revenue from the third quarter. This increase was driven most significantly by the 42% increase in net revenue from ANNOVERA with the average net revenue per unit remaining in line with prior quarters at $1,336 per unit. Additionally, as you can see on the chart, IMVEXXY and BIJUVA also increased by 29% and 36%, respectively, compared to the previous quarter on a net revenue basis. The average net revenue per unit increased to $54 for IMVEXXY and $52 for BIJUVA. As of year-end, wholesale inventory levels for our products were within normal levels of three to five weeks. Moving on to Slide 8, let's review some key financial statement items. Our product gross margin of 75% in the fourth quarter decreased 6 percentage points over the third quarter. Our fourth quarter gross margin was adversely affected by write-offs of finished goods inventory for ANNOVERA of $800,000 and $500,000 each for IMVEXXY and BIJUVA, which were attributable to the pandemic. The results of our previously announced cost savings initiatives and our focus on strict cost discipline allowed us to reduce operating expenses and to achieve our goal of $80 million in OpEx for the second half of 2020. Excluding non-cash items and a performance incentive of $6 million to enhance employee retention across the organization, net cash used in operating activities decreased by $3.7 million from $34 million for the third quarter to $30.3 million for the fourth quarter. While we plan to maintain an efficient cost base that can be leveraged as revenue grows, we expect to make investments this year to improve our supply chain, enhance marketing, and strengthen digital capabilities related to commercial initiatives. With these investments, we expect our cash OpEx per quarter to average $45 million to $48 million in 2021. Turn to Slide 9. In conclusion, I have been pleased with our financial and operational accomplishments over the previous two quarters since I joined TXMD. Over this short time, we have reduced operating expenses and cash burn by successfully meeting our goal of $80 million in cash OpEx for the second half of 2020, strengthened our balance sheet by raising $180 million in cash and committing to pay down $50 million in debt, and revised our revenue covenants to what we believe are minimum levels given the current state of the COVID-19 pandemic. We believe we are well positioned to execute on our commercial plans and poised for continued growth in 2021. I'd now like to turn the call over to Dawn to discuss our payer progress and commercial plans.

Thanks, James. I will start with a quick overview of payer status and then review the performance seen across our product portfolio in this quarter. Let's start with payer access and updates on Slide 11. We have maintained all major payers across the product portfolio; improvement in commercial unrestricted coverage moves ANNOVERA to 78%, IMVEXXY to 76%, and BIJUVA to 75%. Let's move to ANNOVERA, performance on Slide 13. Quarterly total prescriptions filled by patients is on the left-hand side. As you can see, ANNOVERA continued to grow with total prescriptions increasing 15% over the third quarter, coming in at approximately 6,000 total prescriptions for the fourth quarter. Net revenue per unit remained strong at $1,336 and net revenue grew 42% quarter over quarter. Turning to Slide 14. To provide a bit more understanding of our progress, let's look at leading indicators across prescriber and consumer metrics. I'll start with prescribers. Growth in the prescriber base for ANNOVERA is a key level for long-term trajectory. As we've mentioned, prescriber access has been limited during COVID. But we are navigating this and continue to see growth in the total number of prescribers writing, as indicated by the green bars and growth and depth of prescribing as seen by the total prescriptions shown on the blue line growing faster than the total number of writers. Turning to Slide 15, we have leaned into consumer activities given that 60% of birth control decisions are made by the consumer. In December, we launched our celebrity spokesperson portion of the consumer campaign with Whitney Cummings. The program called, Just Say It Vagina. The interest has been significant, with 2.7 billion impressions generated and placements in multiple significant media outlets, as shown in the column on the left. In addition, the early impact results are encouraging. Click-through rates from our advertising to the website are above industry norms. Traffic to the website is growing with over 10,000 visits to the website a day. And in live tech on multiple platforms, after seeing our advertising, the intent to request ANNOVERA rises significantly to 60%. In other words, all leading indicators show the consumer strategy is working, and we believe it will increase the trajectory of antibiotic prescriptions in 2021. Turning to Slide 17. As you can see, we have figured out how to affordably attract consumer interest in ANNOVERA. Where we need to improve and create the next step is converting this consumer interest to fill prescriptions. This progression from interest to conversion is a typical learning process for launch, and we believe we are on the right track to improve the conversion over the next month and quarters. Turning to Slide 17, now we'd like to talk about the value of each patient for ANNOVERA. Each woman on therapy creates a significant amount of revenue value for TXMD, because a full year of revenue is 13 cycles and is earned when the product is dispensed. As you can see by the slide, the cumulative value of ANNOVERA continues to grow with almost 16,000 women on therapy. In addition, we believe our strong retail rate of approximately 50% will create a strong compounded future revenue opportunity. Now let's move to the larger future opportunity for ANNOVERA on Slide 18. ANNOVERA fills the void in the marketplace, and we believe it can create a new segment in birth control. It is well understood that IUDs or implants are not for everyone. Close to half of women reject the offer of an IUD or implant because they do not want to undergo a procedure. In addition, over half of OB GYNs don't conduct procedures and therefore are in need of a long-acting option to provide their patient. The solution to both of these issues is ANNOVERA. Turn to Slide 19. A growing trend in the marketplace is procedure-free at-home solutions. One successful example of this is Cologuard, a procedure-free at-home solution for colorectal cancer screening. It removes the barriers to entry for many people reluctant to undergo a procedure. In fact, of the 3 million people screened with Cologuard, half of them were previously untested. We believe ANNOVERA can expand the long-acting segment for the birth control category in the same way. We're removing the barrier to entry for those that want a long-acting product but are reluctant to undergo a procedure. Turning to Slide 20. Let's look at the contraceptive continuum. On the left-hand side of the chart are daily and monthly options that are procedure-free but short-acting and declining. And on the right are options that provide the benefit of long-acting but require a medical procedure and are growing. ANNOVERA to the left of the long-acting segment fills a market void of a long-acting product that does not require a procedure. In filling that market void, we believe ANNOVERA creates a new segment in birth control as Cologuard did for colorectal cancer screening. Turning to Slide 21. In the evidence for ANNOVERA to become a new segment in the marketplace is in the data. On the left-hand side of the chart are the main segments of birth control. Moving to the middle column here you see actual patient data from vitaCare and which birth control women were on prior to switching to ANNOVERA. Moving to the right-hand column, this is survey data on where prescribers claim they switch patients from given the multiple benefits of ANNOVERA. The main takeaway from both sets of data is the same: Over half of prescriptions are coming from products that are not NuvaRing, as the benefits of ANNOVERA are more than the birth control form. Moving to Slide 22. Before closing on ANNOVERA, let's spend a few minutes grounding us in the larger financial opportunity. Birth control is a large market with 18 million women and 28 million new prescriptions annually. To put the ANNOVERA opportunity in perspective, traditionally, leading products in this category over time have achieved 4% to 5% market share. As you can see in the middle column, Lola Western launched in 2011 and achieved that share in approximately four years. Cologuard, which is in a different market but offers the procedure-free at-home benefits, achieved the same share of 5% of the screening market in five years. If ANNOVERA achieved this level of success, you would see approximately 720,000 prescriptions annually. Now, let's review our menopausal product. Turning to Slide 24. IMVEXXY quarterly total prescriptions filled by patients is on the left-hand side. Total prescriptions decreased 5.6% to approximately 123,000, a result of NRx decline in previous quarters, which was attributable to the pandemic. In good news, new prescriptions have begun to recover and increased 2.5% for the fourth quarter over the third quarter. Net revenue per unit improved to $54 and net revenue improved 29% Q4 over Q3. Moving to Slide 25. Our primary goal for IMVEXXY in 2021 is to improve the gross to net. To support net revenue per unit growth, effective January 1, our cash pay program and high-deductible patients' co-pay increased from $50 to $75. The expected positive impact on IMVEXXY's gross to net is significant. The cost program change was expected to put pressure on volume, but at the same time, we rolled out the cash pay program change. We also gained preferred status for IMVEXXY with a top PBM that covers approximately 20% of life to counterbalance. In January, the PBM removed key branded competitors including Premarin, which currently has 17% total prescription market share. In addition, we are continuing to focus on patient adherence to retail partnerships to drive higher retail rates across distribution channels. Turning to Slide 26, performance in January based on the combination of changes is as expected. In January, we saw a short-term impact on volume; however, early indicators for February show that volume is beginning to recover. In addition, we are seeing improvements in the dedication rate, net revenue, and net revenue per unit. Today an approximately $17 improvement in cost per fill is being realized for those who use the co-pay program. Turning to Slide 27. Finally, a driver of growth is consumer demand. During the first quarter, we launched patient testimonials to help women better understand that symptoms of menopause are common and normal. Moving into the second quarter, we plan to launch a new consumer campaign grounded in self-care that is designed to educate menopausal women on overall vaginal health and encourage them to take charge during this new life stage with IMVEXXY. Moving to Slide 29, I'd like to quickly touch on BIJUVA. Even with our decision to deemphasize BIJUVA and with only seven sales representatives promoting BIJUVA in the field, we continue to see slight growth in TRx for the quarter at 3.3% while maintaining NRx. For the fourth quarter, net revenue per unit improved to $52 and net revenue increased 36% over the prior quarter. I would now like to turn it over to Rob for closing remarks.

Thanks, Dawn. Let's move to Slide 30. We've transformed our capital structure. We've improved our balance sheet, updated our revenue covenants, and have the framework in place to accelerate both ANNOVERA and IMVEXXY adoption throughout 2021. Last but not least, our vitaCare divestiture is moving forward, and we believe we're very well positioned to continue our growth to anticipate even a break-even in the first half of 2022. Thank you all for joining the call today. And we'll now open up the call for questions.

Our first question comes from Louise Chen with Cantor.

Hi, congratulations on the quarter, and thanks for taking my questions here. So the first question I have for you is on vitaCare. Any update on how you think about valuation? You had given us some thoughts before and then the timing of the sale? Could we see something this year? Is that what is anticipated? And then the second thing is how should we think about gross margins in 2021? You gave us some good metrics for sales and OpEx. And then the last thing is how much of an impact do you anticipate COVID to have in 2021? And the reason I ask is, as we think about 2022, should we expect a step up in sales? Thank you.

Yes, Louise, it's Rob. Regarding vitaCare, I definitely expect something this year as we have multiple interested parties and things are progressing well. For gross margins, we outlined clear expectations at the JPM presentation, including for the vaccine. With ANNOVERA, we projected $1,050 to $1,200 based on expected government channels opening and additional rebates, assuming COVID improves. We anticipated closing the year around $1,336. As the government channels like Medicaid and DOD open up, I believe we will see steady quarterly growth for IMVEXXY, with further updates by June. Concerning COVID, we expect that while the first half of the year may pose challenges for our Salesforce, we anticipate a strong recovery in the latter half, leading to significant revenue growth this year and the next, accelerating quarter over quarter as conditions improve. Additionally, our long-acting product is gaining traction, with over 10,000 women visiting the ANNOVERA site daily, which presents us with opportunities for low-cost volume growth. We are also initiating conversion initiatives that could provide a robust revenue stream moving forward. Dawn, do you have anything to add?

And maybe I'll just add about the COVID impact. I mean, I think what's really interesting here is that, you know, what we're seeing, despite COVID, is ANNOVERA growing quarter-over-quarter at 15% and net revenue increasing 42%, quarter over quarter. And you know, what's really nice about ANNOVERA, and if we could go to Slide 17, is that during this environment, what's fantastic is that the value of every script, the realized value of every script for ANNOVERA and the aggregate amount of women on therapy creates a lot of value for us for TXMD, which is really nice in this COVID environment as we navigate it. So essentially, you know, we're in an annual product living in this monthly data world. And so what that means is that every time a prescription is written for ANNOVERA, we receive a full year of revenue, versus the one month of revenue for other monthly products. So every time you see an ANNOVERA prescription, it's actually 13. And again, that's really helpful for us during the time. And as Rob said, in terms of how are we going to accelerate growth with COVID? What's the impact, Robert mentioned the first part, when COVID receives the Salesforce accessible normalize, which will naturally help us accelerate. And because we generated significant interest in ANNOVERA, and I'll tell you that the procedure-free long-acting message resonates with prescribers; it resonates with consumers. Right now, we're just focused on conversion. And we can reach consumers digitally in a COVID world. And so that's going to be really helpful. But ultimately, we believe that the access restrictions will lift in the back half of the year that will allow us to accelerate.

Thank you.

Our next question comes from Annabel Samimy with Stifel.

Hi, thank you for taking my question. I have a straightforward query. If you take your prescriptions and multiply them by the net price mentioned in your press release, the numbers don’t add up. Are there additional factors we should consider? Specifically, what variables should we keep in mind going forward when discussing net price ranges for both ANNOVERA and IMVEXXY? Also, is there any update on the discussions with the FDA regarding hormone therapy? We haven't discussed much about it recently due to COVID, but once things stabilize for the other franchises, are you planning to resume marketing efforts? Thank you.

On a question about the difference between gross to net and the units, our demand in the channel for the quarter was very strong and it illustrates that Symphony does not pick up all the sales from certain channels where patients fill their prescriptions, resulting in underreporting of units. Second, we maintain better than expected net revenue per unit for all of our products. And we accomplished this growth in sales while maintaining typical inventory levels of approximately four weeks into the channel. Does that answer that piece of it?

I mean, the net price that you're listing in the prescriptions that you reported. Are you saying that there are other prescriptions in the channel that you're reporting revenues on, recording revenues on rather?

What we're saying is there's a mismatch between the numbers reported by Symphony and the units into the channel versus what our sales are.

Yes, if you take our next time, the units, you get the revenue that's reported. The reason that that's so high is because we think Symphony is reporting low.

Okay, do you have a sense of the percent that they're reporting low?

It's hard because there are so many new channels. That's something we're really working on. It's hard to say at this point; I'd hate to guess and be wrong. But we're working on that one with them.

I mean, how do you record your revenues, and if you're guessing as to underreporting in the channel?

You take your revenue? Let me turn it over to finance?

Yes. Hi, Annabel. So I think what you're hitting upon is, our revenues are done on a GAAP basis. So that's when we sell onboard to wholesalers. And I think the numbers that you were looking at, you were trying to take, like scripts that you see being dispensed to patients and multiplying that by the average $1,336. Is that what you were intending on doing?

Well, I mean, that's just what you reported in the press release. So I imagined that would be the accurate number. But, I mean, we can take that offline. You know, I guess if that's the case, and how should we think about net price and applying that going forward? If there are variables that are unknown, I suppose, you know, how should we think about that?

So the thing is that there's a difference between the scripts that are dispensed and what we sell, what we sell the ex-factory, right from us to wholesaler. So there's always going to be ebbs and flows and wholesale buying patterns and so forth. So they will never exactly match up, you know, one for one. But just in terms of an overall framework of doing it, you know, for us, I think you assume that that kind of normalizes over time, and that's the way I think you'd go about doing it if you wanted to model that way.

Okay, well, then maybe we can just move on to the next question regarding NASEM. Any progress there in terms of their discussions with FDA and compounding and what you're doing with BIJUVA?

Yes, so our goal is to get to EBITDA breakeven first half of '22, and we're on track for doing that. At that point, we can reevaluate BIJUVA. Also, you know, you're right, the COVID overcast can certainly create tailwinds or headwinds as it lifts or moves forward. And then we'll see what the FDA does with NASEM on top of that. So we got to wait and see how each card flips over. But certainly, it's a great product. And you see, we only have seven people behind it and it's moving upwards. So there's definitely a market there. It's a matter of resources for us and shareholder goals. So we'll get it going though.

All right. Great. Thank you.

Our next question comes from Douglas Tsao with H.C. Wainwright.

Hi, good morning. Thanks for taking the questions just on the balance sheet. Just curious if you know if and an account like it's going to be more like a when you're able to divest the vitaCare business. Will you plan on paying down more debt? Is that an option for you? Or, you know, what are your thoughts in terms of the use of proceeds? Thank you.

Yes, thanks for the question. So, when I first started, we had extensive venture debt here whose covenant package was set long before COVID. The pay down that we just did really creates optionality to keep our current debt structure or allow us to pursue lower cost debt in the future, as market conditions allow. Whether or not we do further pay down, I think that's subject to a bunch of different analysis here. But we'd like the optionality that we have. Additionally, with that consent of vitaCare, which you brought up that improves our focus, and allows the vitaCare business to maximize its value in which we plan to return an interest. So I really like the setup here that we now have, and I think we're in a much better position, balance sheet-wise.

Doug, I don't think we'll be paying down any more debt in the near future, to the current expectation; to answer your question.

Okay. And then just in terms of the gross nets, we're obviously seeing some improvement, especially for IMVEXXY. You know, sometimes things get a little squirrely in the first quarter with just deductible resets, and you see greater utilization of plans. But I know you've made some changes. So should we see further improvements in the first quarter? Or will that come perhaps later in the year? Just trying to make sure we get everything straight for our modeling standpoint? Thanks.

So I'll turn it over to Dawn and Mitch. But the co-pay card, the increase in the cash pay price was an immediate impact. The next piece that you would see unfold during the year would be the high-deductible plans and things meeting their goals and more insurance coverage kicking in. So we would expect it to continue throughout the year.

I would, when looking at that, I would really look at quarter-over-quarter. So first quarter of 2021 versus first quarter of 2020. And from that regard, typically you see a decrease in the cost of net revenue. We may see one this year, but we don't think the impact will be significant given the changes we made with insurance and the co-pay card.

So pretty positive.

Our next question comes from Dana Flanders with Guggenheim Partners.

Hi, this is Devin on for Dana Flanders. I've had two quick questions. One was just regarding the new preferred TBM position for ANNOVERA and IMVEXXY. Just wondering how I guess share gains are tracking. I know it's early in the year. But you guys that got it to about 10% to 20% share gains back in January. So just seeing if you still expect that to be a tailwind into 2021. And I have an additional follow-up.

Yes, we absolutely do. I'll turn it over to Dawn. So far, it's early to track that. But as we showed in the slides, I had a pace. So when we raised the cash pay from $50 to $75, we expected a fall-off, as we said back at JPM through February, and then to return in March to back to growth. That fall-off kind of stopped at the end of January. And we've kind of returned to growth about two or three weeks sooner than we thought. So that is trending well. We expect that to accelerate with that contract throughout the year for sure. We feel good about that.

Yes. Hi, Devin. And the only thing to add is that as Rob said, it's early; what we would expect to see or gauge in the second quarter and forward. But as Rob said, given that we're not seeing as much of an impact from especially within IMVEXXY with the co-pay change, we're confident that some of that is because of the preferred coverage at the PBM.

Well said. Okay, great, thank you. And I just had one additional one. I know there's been, I guess, a more recent launch of NuvaRing generic at the latter half of 2021. And I know there's also a new generic launch of new lane. Just seeing how you guys expect that to kind of impact which is for ANNOVERA in 2021?

Yes, so you know, as you can see on Slide 21, that if you see the actual positions, two-thirds of the scripts aren't coming from NuvaRing. And if you go to the patient, about 40%, 44% are coming from NuvaRing, so we're just not seeing the impact. You know, what ANNOVERA was developed to be was not NuvaRing 2.0, but rather what the population council wanted, which was a long-acting product that was procedure-free and lasts for a full year. And that's been something for women that didn't want or couldn't have IUDs or implants. A lot like Dawn mentioned Cologuard, right, they removed the procedure aspect of Colon cancer screening. And it worked very, very well. Well, ANNOVERA does the same thing for IUDs and implants, it removes the need for a procedure. And we're seeing that in the data. So as much supply that comes out there, we need, I think you'll see the NuvaRing contribution or previous NuvaRing users contribution to our overall revenue shrink, not grow. I think you'll see other sources continue to grow. Because what we're finding is the way we're positioning it, the way the doctors see the void in the market, and avoid the market that we are currently filling. And that's where all of this web interest and web traffic come from with women that we've been impressed by is truly that long-acting procedure-free, which the population council developed it to be. So I don't think supply, to answer your question of NuvaRing, is going to impact ANNOVERA trajectory at all. There is always going to be a subset of ring users. We have that in the long run, probably 33% to 24% of the overall, whether you're looking at their market share or our ultimate market share. So we expect these numbers of NuvaRing users to go down, not up, and we'll continue to track them.

Great. Thank you very much.

You got it. Thanks for the questions.

And I'm not showing any further questions at this time. I turn the call back to Rob for any closing remarks.

Thank you, everybody, for joining the call today. I'm really excited about how we're positioned for the future with the new revenue covenants that strengthen the balance sheet. Our progress, the vitaCare situation moving forward, and progressing. So thank you all. We'll see you all next quarter and thank you for your interest.

Ladies and gentlemen, that concludes today's presentation. You may now disconnect and have a wonderful day.