TherapeuticsMD, Inc. Q1 FY2020 Earnings Call

Good morning, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD First Quarter 2020 Financial Results Conference Call. Following prepared remarks from the company, we will open the call for questions. I would like to turn the conference over to TherapeuticsMD's Vice President of Investor Relations, Nichol Ochsner. Nichol?

Good morning, everyone. Thank you for joining today's call to discuss our first quarter financial results and business update. This morning, TherapeuticsMD issued a press release announcing our first quarter financial results. The press release is available on the company's website, therapeuticsmd.com in the Investors and Media section. On today's call from TherapeuticsMD are Chief Executive Officer, Robert Finizio; Chief Commercial Officer, Dawn Halkuff; and Mitchell Krassan, our Chief Strategy and Performance Officer. Dan Cartwright, our Chief Financial Officer is not able to attend this call due to travel limitations. I would like to remind everyone that certain statements made during this conference call may be forward-looking statements. 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, 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 and Media section of the company's website. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on May 6, 2020. With that, I'll turn the call over to TherapeuticsMD's CEO, Rob Finizio.

Thanks, Nichol. Good morning and thank you for joining today's call. On this morning's call, I will start with a strategic overview, review Q1 financial results and performance metrics, our strategic plan to successfully navigate COVID-19 and our approach to return to our pre-COVID-19 revenue trajectory, putting us on the path to reach EBITDA breakeven in 2021. Turning to slide 3, our approach is strategic, it's highly focused and it's achievable. Now that we have patient, provider and net revenue data on all three of our products, we have developed a path to reduce overall expenses and reallocate our resources. Next, we are positioned to capitalize on the emerging market trends that have been accelerated by COVID-19 to drive growth with our retail and online distribution channels. Last, in the short term, we have adjusted our strategy to be exclusively focused on ANNOVERA and IMVEXXY. Turning to slide 4, ANNOVERA will remain our primary focus because of the positive market reception and net revenue per unit results that are a full year ahead of our internal expectations. IMVEXXY is our second priority as it has gained traction amongst the prescribing population and is now the fastest-growing product in the VVA category. To fund these initiatives, we are going to pause the majority of BIJUVA-related promotional activities due to COVID-19. By pausing promotion and organizational support of BIJUVA, we have been able to reduce our costs considerably and develop a plan that continues to drive our revenue trajectory. I will cover our expected operating cost reductions for the rest of 2020 later in the presentation. We have opened discussions with TPG Sixth Street Partners around COVID's impact to our revenue for a potential adjustment to our minimum revenue covenants. I will cover this in more detail later in the presentation. And finally, we pride ourselves on being a nimble organization that recognizes emerging trends and adapts accordingly. COVID-19 has accelerated telehealth, online and retail pharmacies utilizing home delivery options. These are areas we've been developing relationships with the industry's leaders and emerging technology companies, and therefore, we believe we are well positioned to capitalize on these accelerated trends. In addition, given the job losses due to COVID-19, we believe the Medicaid population will significantly expand. As you will see today, we have gained significant Medicaid coverage for our portfolio this year. While the duration of the crisis is unknown, I believe that TherapeuticsMD is well positioned to navigate the challenge, pick up where we left off in late February, and emerge from this unprecedented global health crisis to achieve our business goals of growing long-term shareholder value. Now let's move to the metrics for the first quarter. On slide 7, total net revenue for the quarter ended at $12.3 million versus Wall Street consensus of $11.4 million. This is now the fourth consecutive quarter that we have beaten Wall Street consensus. I'm very proud of the team's performance this quarter. As we previously guided, quarterly net revenue for the first quarter is down from the fourth quarter. As a reminder, in the fourth quarter, net revenue includes a build for the initial distribution of ANNOVERA as we prepared for the full-scale launch in the first quarter of 2020. We saw units sold to patients demand double from the fourth quarter and this outpaced restocking into the channel for the first quarter. In fact, patient demand increased across all products compared to the fourth quarter and outperformed on revenue expectations even with the industry's annual occurring insurance resets and the quarter heavily impacted by COVID-19 pandemic in March. For more details about the first quarter results and performance please refer to our press release and our full Q1 2020 10-Q. I'd now like to turn the call over to Mitch Krassan, our Chief Strategy Officer to review some key metrics.

Thank you, Rob. I would like now to review key metrics for each of our brands. Let's start with ANNOVERA on slide 8. In this quarter, we delivered net revenue of $1,350 per unit, which was consistent with the fourth quarter and we had an adjudication rate of approximately 100%. Additionally, 77% of ANNOVERA patients are paying zero co-pay and we had a total of 2,361 prescriptions to patients in the first quarter from 1,140 providers. Please move to slide 9. Our planned launch of ANNOVERA occurred in a quarter that was interrupted by COVID-19. As you can see on the slide, we achieved total unit growth during our soft launch in January and February. However, in March, we experienced restricted provider access and a lack of consumer mind share prompting us to pause the full commercial launch. Moving to the right portion of the chart, you can see how this impacted March sales of ANNOVERA to patients. We believe the strong reception ANNOVERA received in January and February can be resumed when ANNOVERA's consumer campaign and full provider engagement occur in early Q3. Let's move on to slide 10. Despite COVID-19, IMVEXXY continued to grow during the first quarter, as it has a more established base of business. Specifically, IMVEXXY achieved net revenue of $6.4 million with 134,000 total prescriptions sold to patients in the quarter. Calculated net revenue per unit of approximately $48 was slightly down from the fourth quarter due to insurance resets that impact the industry annually in the first quarter. The overall adjudication rate for IMVEXXY was 44%. In addition, we had 17,000 providers writing in the third quarter a significant percentage of the targeted prescribing population. As we have done since the beginning of launch, we continue to focus on consumer refills. For those patients who started on IMVEXXY over one year ago, they have averaged over six fills since starting therapy. In 2019, our average fills per patient was 4.2 fills. This focus on refills ensures our acquisition dollars work harder as it increases the lifetime value of the patient. Finally, let's move to BIJUVA on slide 11. In the first quarter, we achieved net revenue of approximately $1.1 million with total prescriptions to patients of approximately 26,000 units. This represents solid growth over the fourth quarter. The first quarter calculated net revenue per unit was $43, a decline from the fourth quarter again caused by the impact of industry-wide insurance resets. The overall adjudication rate for BIJUVA was approximately 51% with 5,000 providers writing a prescription during the quarter. I would now like to turn the call back over to Rob.

Thank you, Mitch. Moving to payor access on slide 13. In the first quarter of 2020, ANNOVERA experienced rapid uptake, surpassing the progress of IMVEXXY and BIJUVA in January regarding payor coverage, adjudication, and net revenue per unit. We were also added to the Department of Defense formulary and are being sold to 92 military bases, with availability for Title X entities expected in early May. We anticipate that universities will start adopting and prescribing it in the fall of 2020. Furthermore, we are making strides in Medicaid, which accounts for 15% of the market opportunity in the contraceptive sector. I am pleased to report that ANNOVERA now has Medicaid coverage in 37 states. We believe that ANNOVERA is well positioned for growth with 76% commercial coverage and no co-pay for about 77% of patients, even without the 19th category. We continue to engage in positive discussions with the FDA regarding the 19th category. Moving on to the menopause portfolio. On slide 14, let's look at IMVEXXY. Access remains at 72% for the commercial book of business. While we did not gain any significant Medicare Part D payor additions in Q1, we still expect to obtain preferred status from two of the three major providers. We recognize that COVID-19 is causing additional delays in Part D decisions, but we are actively exploring options with these payers. Since January, IMVEXXY has expanded to 21 states with unrestricted Medicaid access at an average co-pay of $5 or less. Now regarding BIJUVA, since January 1, we have improved Medicaid access to 21 states, also unrestricted, with a co-pay of $5 or less. BIJUVA's commercial access stands at 54% unrestricted, and we are in talks with a few remaining top payers. Turning to slide 16, due to the effects on access to providers' offices and the uncertainty surrounding the length of COVID-19, we have modified our expense structure. Our strategy involved reviewing the organization to cut expenses related to BIJUVA and areas not generating immediate revenue. This allows us to preserve funding for ANNOVERA and IMVEXXY after COVID-19 while lowering our operating expenses for the year, keeping us on track for EBITDA breakeven in 2021. On slide 17, we maintain a strong belief in the long-term trajectory of our portfolio. However, like others, we do not have full visibility on the immediate impact. We have made several assumptions: Firstly, access to providers' offices will likely remain limited through May, and we expect to regain access in tandem with state reopenings, returning to more normal access levels by the third quarter. Secondly, we plan to reactivate commercial plans early in the third quarter, including launching our consumer campaign called UNAPOLOGETICALLY ANNOVERA. We also aim to enhance consumer investment for IMVEXXY and reengage our sales force in a live model as access improves across the country. In the near term, we anticipate a revenue impact in Q2 due to COVID-19 but expect to regain our growth momentum in early Q3, aligning with the full reengagement of our commercial plan. Moving to slide 18, in light of the anticipated impact on net revenue, we have worked, as previously mentioned, to reduce our expenses for the remainder of the year. The operating expense for the first quarter was $57.5 million, which includes a one-time expense related to preparing for the ANNOVERA launch. We expect second-quarter expenses to be $10 million to $12 million lower than the first quarter through marketing spend deferments and other immediate cost-reduction measures. With the additional cost cuts, we foresee operating expenses in both the third and fourth quarters being around $40 million or less per quarter. We believe these actions will help us reduce our cash burn while still positioning us to achieve EBITDA breakeven in 2021. On slide 19, due to the uncertainty arising from COVID-19 and its consequences on our business, TXMD has been in discussions with Sixth Street Partners regarding the revenue covenants in our loan agreement. We are collaborating with Sixth Street to postpone the scheduled start of our quarterly revenue covenants for two to three quarters to account for the effects of COVID-19. Sixth Street has shown preliminary support and recognizes the need for flexibility for our company during this pandemic. We appreciate their ongoing support. Now, I would like to hand the call over to Dawn to go over our plans for the second half of the year.

Thank you, Rob. You have now seen our strong first quarter results and the strategic and cost changes due to COVID-19. Now I would like to discuss the path forward for each of our brands and why we believe we can pick up with the growth trajectory we saw in February, before COVID-19. Let's start with ANNOVERA on Slide 21. We believe that once our plans are fully deployed we will see fast uptake. Let's walk through the why. Starting with the column on the left, ANNOVERA is in the contraception market, which is the largest U.S. women's health category at $5 billion. Within that $5 billion are 500,000 prescribers and 18 million women. Stated simply, this is a market where small shares drive big gains. Moving to the middle column. Although we have had limited time with ANNOVERA on the market, proof-of-success was seen in Q1, given the strong reception we had with the limited focus in January and February. In the first quarter we had 1,140 prescribers writing ANNOVERA leading to 2,361 total prescriptions. This result was with the COVID-19 impact and our sales representatives calling on only 10 providers and limited consumer spend. In the third quarter we will see exponential growth in the number of providers each representative will focus on with ANNOVERA and expect to see the impact from that investment. Sales representatives will call on 125 to 150 providers with ANNOVERA as the primary focus. In addition, we plan to launch our consumer campaign called UNAPOLOGETICALLY ANNOVERA, which is an impactful campaign that should quickly gain traction. Moving to the third column over to the right. In addition to growth from our sales force efforts and our consumer media campaign, ANNOVERA will grow through multiple channels and partners. First is our widespread availability to large chains such as Walgreens independent community pharmacies through our BIO-IGNITE program and online pharmacies like PillPack. Second, we are ensuring product access for patients on emerging online platforms such as the Pill Club and Simple Health that both prescribe and deliver birth control directly to patients. Telemedicine including these platforms is growing fast in the COVID-19 world and contraception is an important category within telemedicine. We are well positioned to deliver patient access through this channel as it is a trend we saw and started working on in 2019. Third, public health, which includes universities; 340B which includes Title X; Medicaid with 37 states approved; and last the military ANNOVERA is available to order for women at 92 military bases. For all of these reasons, a large market, early proof of success in Q1 and a planned pickup of our launch in the third quarter, our ability to drive access and grow through multiple channels and partners, I believe we will be able to regain the trajectory we saw pre-COVID-19. Turning to slide 22. Another reason I believe we will accelerate growth is because I understand why ANNOVERA had a strong trajectory with limited focus it is because it is a product that is well positioned with the needs of our provider and patient base now and post-COVID-19. Specifically, ANNOVERA offers one year's worth of protection is a good substitute for elective procedures for women that are unable to get a procedure during this time and want a long-lasting option or women who do not want a procedure. ANNOVERA also covers you for a year even if your insurance situation changes. The majority pay zero out of pocket and it can be delivered to your door. Moving to slide 23. We recently announced the first Orange Book listed patent for ANNOVERA. The O66 patent claims elements of the ANNOVERA label, which a generic would need to copy. The issuance of this patent strengthens the intellectual property protection for ANNOVERA providing Orange Book listed patent protection through 2039. As you can see on the slide, we have a multilayered patent approach that we believe will translate to robust protection through 2039. Let's move on to IMVEXXY on slide 24. As you can see on the left-hand side of the chart, IMVEXXY is the fastest-growing product on the market. Share gains are at the expense of Premarin and we ended March with 10.8% market share of total prescriptions. Our plan forward for IMVEXXY is to continue to focus on our high writers and expansion of the base of productive writers. In Q1, despite COVID-19, we had no drop-off in the number of writers and 10% of our new prescriptions came from new writers to the brand. To support the goal of a breadth and depth of writing, we will continue to focus on activating the consumer to ask the provider about IMVEXXY. Our efforts have already yielded a proactive approach among women suffering from VVA with intent to ask a healthcare professional about IMVEXXY now at 66%. Consumer media activities will expand to support continued share gain in the back half of the year. Finally, let's turn to BIJUVA on slide 25. BIJUVA had steady quarter-over-quarter growth. With our limited focus on BIJUVA, we will focus on maintaining the writer base through the remainder of 2020 supported by non-personal promotion. In addition, we will continue to support our BIO-IGNITE partner program as compounding pharmacists report they would recommend BIJUVA to one-third of their E+P patients. We will continue to prepare for the potential 0.5/100 launch with internal resources for a launch in early 2021 if approved. I would now like to turn the call back over to Rob.

Thanks, Dawn. Before we end, I'd like to welcome our three newest Board members Gail Naughton, Paul Bisaro and Karen Ling. They are a diverse group of health care veterans that already have delivered significant value to the organization. I also want to thank the team for leading through a very difficult and challenging quarter due to this pandemic and adapting quickly and creating the great results we have discussed throughout this presentation. To close, we've had positive revenue momentum and have developed a strategic cost containment plan that will lead us to our ultimate goal of profitability. We believe that our cost containment strategy coupled with our TPG negotiations will create the optionality needed to best create long-term shareholder value and a reflective capital structure. We believe the plans we have in place will continue the trend of consistent growth that we've been delivering over the past four quarters leading to our goal of EBITDA breakeven in 2021. Now, I'd like to open the call up for questions.

Thank you. And your first question on the line is from Louise Chen with Cantor Fitzgerald.

Hi. Thank you. This is Jennifer Kim on for Louise Chen. I have two questions. The first is could you give any more color regarding your revenue covenants? I know you previously said that those were considered in the original revenue guidance. So I'm thinking, if you're deferring it by two to three quarters, does that imply the original $90 million to $110 million revenue range that could also be reached in two to three quarters later than anticipated? And then my second question is, if you could give more color around your OpEx expectations for this year. I know you mentioned, the $10 million of marketing spend is delayed in the second quarter, but it looks like you expect the full launch of ANNOVERA and support for IMVEXXY in early third quarter. And I guess I'm wondering how that translates to total spend of $40 million or less? Is R&D expected to decrease as well, or where are those reductions coming from? Thank you.

Sure. So I'll take the first one with TPG and then there's a number of facets to your second question, we'll address them as best we can. So, look, with TPG, as we discussed during the call, we're in active discussions to defer the scheduled start of the quarterly revenue covenants into 2021. So, given we have an open dialogue around that, we don't want to get into any more detail other than that. And I hope you can understand, it's an ongoing discussion, so to jump into any details, it just doesn't make sense right now. As far as the OpEx, Mitch, do you want to take that?

Sure. As we've discussed, we're currently planning to reduce our overall operating structure by approximately 20%. To use a quick reference to how we got there, if you look at the first quarter total operating expenses, included in there was about $5 million of non-recurring spend. And then we look at cutting about 20% of cost through the organization to get that down to roughly that $40 million number. We plan on doing this by staying very focused on IMVEXXY and ANNOVERA as the lead products, pulling some funds from BIJUVA, so we have ample dollars to meet our revenue trajectory goals.

Great. Thanks.

Good morning. Thanks for taking my questions. Congratulations on the progress.

Hi, Stacy. Thank you.

Just some questions on COVID-19 and potential impact. First on telemedicine, for your existing patient base, what percentage has been converted over to telemedicine, or is in the process of converting? And any commentary on the success? What are the advantages and disadvantages that your sales force has experienced so far? And I have a few follow up.

Sure. I'll address that, and Dawn may want to add to it. There are two perspectives to consider here. We have been collaborating with online partners in the prescribing and pharmacy sectors for several quarters now, and that's where much of our growth is coming from. I appreciate you asking about this. Our business development team has made significant progress with Pill Club, PlushCare, Amazon, and several others that Dawn can highlight, and they are all experiencing rapid growth. ANNOVERA has performed exceptionally well with these partners, and we believe this is just the beginning of a change. As access for physicians has become more restricted, particularly in tight markets like New York and New Jersey, areas such as Arizona and South Florida are starting to open up. Sales representatives are beginning to engage in face-to-face interactions again, although it's not quite what it was previously. In the meantime, we have prepared by staffing up, and we are conducting remote detailing and hosting lunches where reps can connect with doctors digitally. While this isn't as effective as in-person meetings, we have been preparing for this scenario for some time and had the necessary infrastructure in place to maintain operations. Internally, we expect the situation to remain tight through the end of May, with June likely serving as a transition month. We anticipate reestablishing our growth trajectory with face-to-face engagements and launching our Unapologetically ANNOVERA and IMVEXXY marketing campaigns in early July or early Q3. Does that clarify things?

That does. And then, I guess, one last question focusing on ANNOVERA. Have you gotten an idea of trends in terms of patients that are switching from other forms of birth control? What percentage, let's say, are naive? Who's coming from NuvaRing? Who's coming from the pills? Just trying to get a better understanding of where the switches are coming from, to better understand where you guys are going to focus your efforts.

Sure. Hi, Stacy, it's Dawn. So, essentially, we are early on with ANNOVERA, as you know the pill is the largest segment. And so, we certainly are seeing that trend, where we're getting some people from pills less that are naive. We always knew that it was going to be people switching from other products likely than their first form, but early on. And we're also seeing actually that certain healthcare professionals that there are quite a few that are writing NuvaRing that are adopting this more quickly, given their comfort with the ring form. So we're taking advantage of all those opportunities.

Great.

Hi, guys. Thanks for taking my question.

Hi, Annabel.

How are you? So I am trying to understand, I guess how some of these cuts might hamper your ability to sell. I know you're leveraging alternative distribution channels through PillPack, PlushCare et cetera. Could this potentially be a new model going forward? Is the cost structure different for accessing these channels? And can you just help us understand how you might leverage that? Then I have some follow-ups.

Yeah. Sure. I think it'd be a hybrid between Dawn and I to answer. Dawn, do you want to go first?

Sure. I mean, maybe, first, I will go to the sales force side. So first thing, I wanted to mention Annabel is that these other channels exist with the sales force, right? So it's just another way for patients to access their medication. So our only goal right now is to get to profitability and ANNOVERA and IMVEXXY are a best way to get that. So with that, with the sales force we'll be going back to – as a reminder we were talking about BIJUVA having its own sales force back in the fourth quarter. So we're going to go back to one sales force focused on ANNOVERA and IMVEXXY, which allows a reduced size of about 130, which gets us to some of the cost effectiveness we've been talking about.

Well said. So, Annabel, look at it as by pausing BIJUVA that creates resources to create this operating cost reduction and still fully funds IMVEXXY and ANNOVERA. So not just the sales force but a lot of the other costs and support that goes with it around BIJUVA has also been paused. So, that by itself is giving us the resources we need. Now, the trade-off is, until we turn that back on out years like year two and year three, where BIJUVA would really pick up we're not going to have that until we turn it back on. But look it will still be there in a year. We are definitely driving towards profitability or EBITDA breakeven in 2021. And this plan allows us to lower all of those operating expenses costs and doesn't really affect the revenue trajectory in the first year or so. So we think although, it's the best of both worlds, it will get us to profitability as fast as possible.

Okay. Great. And then can you talk about any coverage changes that you've had? So, I missed the comments earlier. I don't know, if you made any progress with Medicare. If there's been any changes to coverage there and if everything is status quo or improving versus status quo and declining?

Yeah. So everything is improving. So we've done a lot. So, starting with ANNOVERA we're up to 76% coverage and 77% of those patients have a zero co-pay. So it's just – it's just great, right? The growth – 15% of the market which is given the size of the birth control market, 15% of that market is Medicaid and with ANNOVERA we are going straight at that. We think that Medicaid market due to COVID and all the job layoffs is going to grow. So we have picked up since we spoke last 37 states in the Medicaid environment. So it's full force ahead with ANNOVERA there. When you get to IMVEXXY we did not add any Part D payers for IMVEXXY in the Part D category yet. COVID has really slowed that process or focus there down. We still feel good about two of the three payers being very positive for us when they do start adding again, and are very clearly, waiting for that to happen. And – but we are behind on the Part D for IMVEXXY. As far as the Medicaid access for IMVEXXY and BIJUVA, we've added 21 states at a co-pay of $5 or less. We've also added a number of smaller players, no big names that you'd probably know. So, look nothing is going backwards. Everything is moving forward and we feel good about our progress, we really do.

Okay. Great. Thanks. I'll get back in the queue.

No problem. Thank you.

Your next question is from Doug Tsao with H.C. Wainwright.

Hi. Good morning. Thanks for taking the question. Just maybe Rob could you talk a little bit about some of the dynamics that you're seeing in the ring market just obviously given COVID-19, which I would think would enhance some of the characteristics of the type of product? But also just given the launch of the generics for NuvaRing at the end of last year and how that is potentially affecting the landscape?

Yeah. Thanks. So the ring market was specifically to ANNOVERA, around COVID and then around the overall market, including the generics of NuvaRing. The synergies line up pretty well. If you lose your job and you lose your insurance and you don't want to pay for the pill every month, you can get ANNOVERA. Most patients get it for free, with their insurance. And now the Medicaid market as well right, $5 or less and it lasts throughout a year. For doctors that can't do elective surgeries and they want to put patients on something that is long-acting, it fits very well. So the trends are certainly in ANNOVERA's favor with COVID. The generic ring, NuvaRing, we really don't see as an impact. Everywhere we go, people really look at this as a long-acting option that lasts for 13 cycles as opposed to lasting for three weeks. And that seems to be where physicians and women now that we have a lot more data it really resonates with them. It's the control they have without having to have a surgical procedure that other rings just don't offer because they're disposable and short cycle. So we've got a number of NuvaRing users that have come in as well as IUD, and which is a surprise a number of pill users that are switching over. We expect in the next quarter or so to have a much stronger amount of data for the street on the user types, the user experience and what is drawing them to try ANNOVERA. And then as we go further out the continuation rate.

And then maybe Rob just as a follow-up. Just given some of those things that you spoke about and how this product really works with telemedicine model, why necessarily pause some of the consumer outreach or consumer marketing plans? Why not press ahead on that front and maybe pull back in some other areas of the business?

Yes. There are two points to address. Dawn and I will respond to that. It's a good observation. Initially, we discovered that investing in marketing during the pandemic, when mortality rates were rising, was not in our favor due to the high costs involved. However, our partners, including PillCare, Pill Club, PlushCare, and PillPack, are actively spending on advertising and their user base is expanding quickly. Their investment in promoting our product or others aligns with their business model and does not affect our financials. This creates a beneficial synergy for us. Dawn, would you like to add anything?

Yeah. I think the only thing to add is that when all of this first started and we mentioned it here, we didn't have complete visibility into the length of time that was going to last and we wanted to make sure that the money we put out there, the spend we put out there would be consistent. And so as Rob said given that we knew the mind share was elsewhere, given that we knew very little about it a couple of months ago, we made the decision to pause and be able to continue volumes through some of these other partners. It was a better use of spend. And when we do put it out there, it will be with the other commercial levers including the sales force being able to go back to a live model and that will just work harder for us.

Okay, great. Thank you so much.

Thanks, Doug.

Good morning, team. Thank you very much for taking my question and congrats on the progress. I have two questions. First one, if you could provide some color on the second quarter sales and growth trajectory as we've seen a larger impact with the coverage restrictions. And my second question is on telehealth side, how much active users do you have? Did you see some growth? And what are the expectations moving forward?

Thank you for the question. As you can see from the monthly data we provided, we exceeded our COVID-related guidance. However, if COVID hadn't occurred, the reception for ANNOVERA in January and February was very positive. It's important to remember that each sales representative was limited to contacting up to 10 doctors in their territories. With our full advertising campaign for both IMVEXXY and ANNOVERA launching in March, and each representative reaching out to 135 to 150 doctors, we believe the reception would have significantly increased, leading to an even stronger quarter. Unfortunately, we cannot spend the funds twice. We noticed that as COVID concerns grew, many offices closed just after our national sales training in the last week of February, and by mid-March, most were only conducting remote visits and providing samples. This forced us to pause our efforts on ANNOVERA. With our expected reopening in early July, we plan to reactivate all of our initiatives and resume our growth trajectory, utilizing the additional resources we had planned to deploy back in February when representatives were only contacting 10 doctors and our marketing efforts were still ramping up.

And maybe I'll take the telehealth portion of that question. So a couple of things there. First of all, when we're talking telemedicine, Rob mentioned the number of partners that we're working with, but also what you need to understand is all doctors right now are using telehealth. And so the fact that ANNOVERA can be prescribed virtually can be delivered to your door so it's driving a lot of our volume. Now while I can't tell you the exact amount right now that's going through these new emerging technology companies, I can tell you that we monitor it week-on-week and that the volume has been increasing. And so it's definitely gaining traction. If you look at every industry report out there and telemedicine, which was already moving is certainly a wave that will continue to grow.

Hi. Hey, Rob. Thank you very much for the questions. I have a couple. My first one, and apologies if I missed this, but just on IMVEXXY, can you elaborate a little bit on just what the reason is for the delay on Part D? Is that IMVEXXY specific, or are you seeing other drugs get impacted on timing for decisions as well? My second question is on BIJUVA, just kind of what's the deciding factor for when you decide to turn back the focus on that product? Is that when you reach kind of overall profitability? Is that when you see more progress in BIO-IGNITE? And just how do you balance what's good for profitability near term versus what's good for the product's long-term outlook? And my third one, maybe you can just update us on how you're thinking about the durability of IMVEXXY and ANNOVERA. I know you just had an Orange Book patent listed for ANNOVERA, and I was a little surprised to see a generic filer on IMVEXXY. So maybe you can just discuss kind of how you're thinking about the overall patent state and durability of both of those franchises. Thank you.

Absolutely, Dana. We certainly will provide that update. Regarding the Part D plans, we are confident about two of the three major players, which I believe is influenced by COVID. In terms of estrogen products, I haven't noticed any changes specifically related to estrogen; there may be non-estrogen additions, but there are no notable shifts with estrogen products like IMVEXXY or TXMD. The situation appears to be connected to the challenges posed by COVID and the difficulty in getting plans to focus on product promotions under these extreme circumstances. However, we expect this will improve as offices reopen. We are optimistic about securing two of the three main Part D providers, and we have no reason to doubt that. Concerning BIJUVA, I believe you understand the pause we took and the value it provides. When we reactivate it, there are a couple of key elements to consider: the second dose has a PDUFA date set for November 16, which is for the 0.5/100 dosage, and we will also evaluate the growth trajectory and the pace of progress. We are confident that we can resume BIJUVA from where we paused it. By utilizing additional resources, including representatives covering their entire territories and accompanying marketing efforts, we anticipate potential significant growth. If demand is robust and resources allow, we might launch BIJUVA sooner than expected. Conversely, if growth is slower, the launch might take more time. Our primary goal for 2021 is to reach EBITDA breakeven, and we have a clear plan for both products to achieve that. Regarding the durability of our assets for ANNOVERA and IMVEXXY, ANNOVERA has secured its first Orange Book listed patent, providing exclusivity until 2039. It’s important to note that this isn’t solely about that one patent; we have six additional Orange Book listable patents filed and another utility patent in progress. This extensive protection puts us in a strong position for ANNOVERA's durability. As for IMVEXXY, I cannot comment on any ongoing litigation. However, it's important to highlight that IMVEXXY remains an outstanding product. The value is recognized beyond our investor base and demonstrates the product's worth, which has led some to attempt to challenge the patents and pursue generic options.

Okay, thank you.

Yes, thank you.

Thank you. And at this time, there are no further questions. I'll turn the call back over to Rob.

I want to thank the team for their great work in a very challenging quarter. I hope everyone stays safe during this difficult time, and I believe we will get through it, looking forward to warmer weather this summer. Thank you.

Thank you. That does conclude today's meeting. You may now disconnect.