Good morning, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD Fourth Quarter 2020 Financial Results Conference Call. [Operator Instructions] I would now like to turn 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 strengthen our balance sheet through equity capital raises as we reduce our debt. Before I turn the call over to James to give you the detail on the transformative progress, we've recently achieved. I'd also like to mention that the vitaCare divesture process is still moving forward as multiple interested parties. I will now turn the call over to James. James D'Arecca; : 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…

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 6000 total prescriptions for the fourth quarter. Net revenue per unit remained strong at 1336 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 prescription 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 the 2.7 billion impressions generated and placement in multiple significant media outlets, as shown in the column on the left. In addition, the early impact results…

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 frame in place to accelerate both ANNOVERA and IMVEXXY adoption throughout 2021. Last but not least, our vitaCare divesture is moving forward and we believe we're very well positioned to continue our growth to anticipate it 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.

[Operator Instructions] Our first question comes from Louise Chen with Cantor.

Hi, congratulations on the quarter, and thanks for taking my questions here. So first question I have for you is on vitaCare. Any update about 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 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.

Yep. Hey, Louise its Rob. So as far as vitaCare goes, absolutely I would expect something this year. Assuming if divest, which we have multiple parties interested in and things are progressing very nicely there. I would definitely expect it this year. As far as gross margins go, we tried to put out at the JPM presentation very clear expectations around net for the first time even including in vaccine. So what we did with ANNOVERA is we had 1050 to 1200. And that was based on the back half of the year, the government channels opening up and additional rebates related to government or commercial related to ANNOVERA. And that's obviously assuming COVID lifts. I know, we stayed ahead in 2020. I know we were going down to about 1200, we close here at 1336. So again, if that government channel starting to open up Medicaid, DOD and places like that, I think for IMVEXXY, we put a clear quarterly progression out there. And then by June, I think we have a little bit of color as well. As far as COVID goes, we actually put a step up in scale, where the first half of the year is vaccines begin to take hold, there's certainly a headwind for our Salesforce and getting into new offices, that we believe in the back half of the year will start to lift and getting whatever to this new normal will be in 2022. So we expect strong revenue growth throughout this year and next year. And we think it will accelerate quarter over quarter with COVID lifting. But the other big thing and I'll turn [Technical Difficulty] on. This procedure free long acting product, as you can see, we have over, two quarters ago, we were just starting to learn. But now as you know, the marketing department has over 10,000 women coming to ANNOVERA site a day, and the ability to get a lot of volume moving at low cost with interest, that they've just knocked it out of the park. The next step is the conversion initiatives that she's working on. And that also will bring a strong revenue stream with it that we're just starting on right now. Dawn, 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 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 receive the Salesforce accessible normalize, which will naturally help us accelerate. And because we generated the significant interest in ANNOVERA, and I'll tell you that the procedure free long acting message resonates, it 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, guys, thanks for taking my question. I had first something pretty simple, simple math here. If you just take your prescriptions and multiply it by the net price that we've laid out in your press release, we're not getting to the number. So are there any other variables that we need to be thinking about? And when we think about this, where are the variables that we should think about going forward when you talk about net price ranges for both ANNOVERA and IMVEXXY? And then I guess the next question is if there's any update on discussion between us and the FDA regarding hormone therapy we haven't talked about [indiscernible] much but it's COVID but as soon as things stabilize for the other franchises, are you going to plan on reinitiating marketing there? Thanks.

On a question about the difference between gross to net and the units and the channel, our demand in the channel for the quarter was very strong and it illustration Symphony [ph] does not pick up all the sales from certain channels where patients fill their prescriptions, resulting in under reporting of units. Second, we maintain better than expected net revenue per unit for all of our products. And we accomplished this growth in sales was accomplished while maintaining typical inventory levels of approximately four weeks into the channel. That answer, that 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 as 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's 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 under reporting 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 on board 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 1336. 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's 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 x 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 [ph], 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, we're on track for doing that. And at that point, we can reevaluate BIJUVA. Also, you know, you're right, the COVID overcast can certainly create tailwind 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.

[Operator Instructions] 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 create 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 that we have. Additionally, with that consent of vitaCare, which you brought up that improves our focus, and allows the vitaCare of business to maximize its value in which we plan to return an interest. So I really like to set up 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, were 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 would expect it to continue throughout the year. Okay, Mitch anything you want to add?

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. And we may see one this year, but we don't think the impact will be a significant given the changes we made with insurance and co-pay card.

So pretty positive.

Great, thank you.

Our next question comes from Dana Flanders with Guggenheim Partners.

Hi, this is Devin [ph] 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 additional follow up.

Yes, we absolutely do. I'll turn it over to Dawn. so far it's early to track that. But we are 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 [ph] 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 some of that is because of the preferred coverage at 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, what the a population council wanted with a long acting product that was procedure free, that 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 as 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 a pop counsel 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 questions.

And I'm not showing any further questions at the 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.