Agile Therapeutics, Inc.

Good afternoon and welcome to the Agile Therapeutics First Quarter 2022 Financial Results Conference Call. Please note today's event is being recorded. I would now like to turn the conference over to Matt Riley, Head of Investor Relations.

Hello, everyone, and welcome to today's conference call to discuss our first quarter 2022 financial results and corporate updates. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook and financing prospects for the future, our outlook for the second quarter of 2022, management's expectations for our future financial and operational performance, including our expectations regarding the growth of Twrla, our business strategy, and our assessment of the combined hormonal contraceptive market. among other statements regarding our plans, prospects, and expectations. Such statements represent our judgments as of today, are not promises or guarantees, and may involve risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Please refer to our filings with the SEC, which are available through the investor relations section of our website, for information concerning risk factors that may affect the company. We undertake no obligation to update forward every statement except as required by law. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are Al Tamari, Agile Therapeutics Chairman and Chief Executive Officer, and Dennis Riley, Chief Financial Officer. Following our prepared remarks, we'll open the call to your questions. I will now turn the call over to Dennis.

Thank you, Matt, and thank you all for joining us on the call this afternoon. I will review the key areas of our financial performance for the first quarter of 22 and then provide an update on our cash position and plan to finance the company. I will then hand the call over to Al for an update on our 2022 business plan. In the first quarter of 22, we realized net product sales revenue of $1.8 million, which is near the middle range of our guide. Our cost of product revenues totaled $1.5 million, which consists of direct and indirect costs related to the manufacturing of Twirla sold during the first quarter. We had no charges for obsolescence during the first quarter of 22, and we remained focused on managing our inventory levels to meet the demands of our customers while avoiding oversupply. Accordingly, we are working closely with Corium, our contract manufacturer and supplier of TORLA, to revise the structure and application of the contract minimums for the years 2022 and beyond under our supply agreement. Our operating expenses were $15.8 million in Q1 2022. within our guidance of $15.5 to $16.5 million. We communicated in April 22, and down from the $18.2 million of operating expense for the fourth quarter of 2021. We continue to focus on disciplined spending approach and making the right investments to encourage strategic growth, while implementing what we believe to be impactful partnerships and agreements. We plan to continue to optimize our spending by engaged in targeting focused spending in support of growing TROLA while seeking reductions in other areas of our operation. Based on this plan, we anticipate future 2022 quarterly operating expenses to be lower than those experienced in the first quarter of 2022. For example, our management team has decided to voluntarily forego the annual bonuses for 2021 performance that were awarded in January of 2022, which is estimated to be a result in a savings of approximately $700,000, and that will be used for general corporate purposes. We're examining other areas within our operations that can be reduced in a sensible way that will not compromise our plan to grow TOROS. We closed out the first quarter of 2022 with a net loss of $11.8 million, or $3.78 per share, compared to a net loss of $17.1 million, or $8 per share, for the comparable period in 2021. As of March 31, 2022, we had cash and cash equivalents of $3.7 million, compared to $19.1 million of cash and cash equivalents as of December 31, 2021. The decrease in cash on hand in Q1 2022 reflects our working capital firm during the quarter and a $5 million paydown of our debt with Perceptive Advisors in January. offset by proceeds from a $4.85 million registered direct offering of preferred stock with a single healthcare-focused institutional investor. In April of 2022, we added cash of $4.7 million from the sale of our New Jersey net operating loss, for which a receivable was recorded in the first quarter. Financing updates. We continue to explore financing options to support the growth of Twirl. As we discussed on last quarter's call, our plan to finance the company is focused on three parts. Part one, work down our debt facility with perceptive advisors in exchange for relief on financial coverage. We currently have no plans to further leverage the company and, therefore, will not add additional funds under our debt facility with Perceptive. In January 22, we paid back $5 million to Perceptive, reducing our debt to $15 million. In the second quarter, 2022, we plan to make another payment of $5 million in principle to Perceptive in exchange for further relief. This payment is tied to our ability to raise additional capital. Part two, regain compliance with NASDAQ. As we have previously reported, we were notified by NASDAQ that we are out of compliance with their minimum bid price requirements. To that purpose, we believe we have taken the necessary steps to regain compliance with the NASDAQ stock market and in which, in turn, we'll put us in a better position to finance the company. Part three, raise additional capital. We've been transparent that we will require additional capital to achieve our goal of being cash flow positive. We acknowledge that the capital markets recently have been unpredictable in general and especially in our sector. Our plan is to remain flexible and continue to evaluate all options available to us to finance the company, including the ATM we recently established, further equity offerings, and various business development and partnership opportunities to accelerate our past profitability. We remain committed to our plan to grow revenue while reducing burns. with a goal to shorten the time to become cash flow positive. Al will now provide an update on the business plan designed to help do exactly that. Al, over to you.