TherapeuticsMD, Inc.

Good morning, ladies and gentlemen. Thank you for joining us for the Therapeutics MD fourth quarter 2021 financial results conference call. Following prepared remarks from the company, we will open the call for questions. I would now like to turn the call over to Investor Relations for Therapeutics MD, Lisa Wilson. Lisa?

Thank you, Operator. Good morning, everyone, and thank you for joining us today to discuss our fourth quarter financial results and business updates. This morning, TherapeuticsMD issued a press release announcing its fourth quarter 21 financial results. The press release and accompanying presentation are available on the company's website, therapeuticsmd.com, in the Investors and Media section. On today's call from TherapeuticsMD, our Chief Executive Officer, Hugh O'Dowd, Chief Financial Officer, James Durecka, and Chief Financial Commercial Officer Mark Glickman. 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 are 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 these 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 archive webcast, this call was held and recorded on March 10th, 2022. With that, I'll turn the call over to TherapeuticMD's CEO, Hugh O'Dowd.

Thank you, Lisa. And thank you for everyone for joining our call today. Last quarter, we outlined our immediate priorities. And today, I'd like to share our progress against those stated goals. As a reminder, that list included, number one, driving top-line growth and overall operating performance. Two, addressing our capital structure to ease our restrictive cash and revenue covenants currently in place. Three, eliminating $60 million from our annual cost base, including the successful divestiture of VitaCare. And finally, achieving EBITDA breakeven by Q4 of 22. These are the actions we committed to. Let me first turn to our top-line performance. Our fourth quarter revenue performance was impacted by Antivira manufacturing and supply challenges that we've previously announced. To be clear, our immediate challenge here is not about demand generation, but instead, it's an issue of short-term supply and scale. We believe that this is a temporary event which will be resolved by the end of Q1. Our underlying Annovera demand, according to Symphony, remains significantly higher than our ability to fulfill in this immediate period. As we continue to manufacture and supply Annovera, we have assembled a cross-functional team to ensure that we are efficiently allocating every ring available across our distribution channels. As a company, We are at a pivotal moment that we believe will help transform us into a more focused women's healthcare company dedicated to our mission of empowering women of all ages through better and affordable healthcare. We are implementing changes, both large and small, that we believe will help enable us to maximize our three unique products, Anavera, Invexi, and Byjuva, and thus create and grow value for our patients, customers, and shareholders. As an example, we have recently partnered with GS and Associates to implement an innovative targeting analytics approach designed to allow us to utilize the full productivity of our field force, calling on the highest decile and most productive healthcare providers, as well as optimize our full portfolio of women's health products. Mark will have more to share on this in a few moments. In regard to our second priority, and in support of a new capitalization plan for the company, we have amended our credit agreement with Sixth Street. We believe this was the most prudent way to bridge us through the close of the Vitacure transaction and the refinancing of our Sixth Street debt facility with another party. In a few moments, James will highlight the key details of this amendment. Let me now turn to our third priority, starting with our recently announced transaction to divest Vitacare to GoodRx. Obtaining maximal value for this business unit has been a top priority for us. As announced earlier this week, we entered into a definitive agreement with GoodRx for $150 million in cash, plus additional earnouts of up to $7 million. This reinforces our commitment to maximizing value to our shareholders. We are pleased that we delivered on this important commitment. This transaction enables us to accelerate the transformation of our company, and importantly, it allows us to narrow our focus as a pharmaceutical business dedicated to empowering women of all ages through better and affordable health care. James will offer color on the effect of the VitaCare divestiture on our previously announced cost savings initiative. And finally, with regard to achieving EBITDA break-even, we will provide further details when we discuss earnings guidance in Q2. Pending the closing of our divestiture of VitaCare, we are now poised to address our capital structure, remove Sixth Street as our creditor, and de-lever our balance sheet, thus easing our restrictive cash and revenue covenants. Now, Beyond our progress against our immediate priorities, I wish to provide clarity and more detail surrounding our efforts in regard to Anavera manufacturing. In this impacted period, we have experienced supply disruptions due to a higher rate of batch rejections, primarily associated with a restrictive specification for one test method. Last August, we took action. and submitted to the FDA a manufacturing supplement which sought amendments to our specification for that one test method. Subsequently, we received a CRL last December. The CRL provided a rationale for the rejection of the revised specification, but also provided a pathway for resubmission. We responded to the CRL in January. providing the requested information, and we anticipate FDA response by the end of Q2. So what are we doing today beyond our FDA resubmission? First, we've added resources at our CDMO to significantly increase our production volumes. And second, we have improved our production process to drive a double-digit percentage increase in our yield per batch. To be clear, Our top-line growth assumption does not assume FDA approval of the Anavera manufacturing supplement. Approval would accelerate our ability to achieve this goal, but it's not dependent on that outcome. Based on these factors and the pending sale of VitaCare, we intend to provide earnings guidance in Q2 when we believe we'll have more visibility and we can provide that guidance with greater certainty. Since stepping into the role of CEO, I and the entire Therapeutics MD leadership team have undertaken a number of highly effective steps toward achieving our immediate priorities, thus setting us on the pathway towards attaining a leadership position in women's health. And now, with the PhytoCare Defendant Agreement announced, we are positioned to become a far more focused company and to capture the full value of our portfolio of products. Let me summarize. This is a transformational moment for us. The path ahead is bright, and with the sale of VitaCare, we fulfill our commitment to reduce our annual cost base by $60 million. We believe we are positioned to bring the company to profitability and restructure our capitalization, which we aim to complete in the second quarter. We are on a pathway to successfully scale, manufacture, and supply our flagship product, Anavera. And finally, Our priority is to deliver results to our shareholders and provide a pathway to EBITDA breakeven. Our company core values of high standards, empowerment, and respect mean a lot to me and will be reflected in all the work we do moving forward. And with that, I'll turn it over to our Chief Financial Officer, James Durecka, to discuss our financial results in greater detail. James?