Clarus Therapeutics Holdings, Inc.

Thank you for joining in the Clara's first quarter 2022 financial and operating results conference call. Today's call is being recorded and webcast live on the company's website at www.clarastherapeutics.com in the investor relations section and will be available for replay for 10 days following this live call. Please note that discussions today may include forward-looking statements. These forward-looking statements include statements regarding the market opportunity for Jatenzo, the anticipated benefits of recent patient initiatives, and statements regarding the CLARUS growth strategy, its pipeline and IP portfolio, among others. Forward-looking statements involve a number of risks and certainties, some of which are beyond CLARUS control. or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include but are not limited to the risk associated with pharmaceutical development, risk associated with the CLARIS financial position, and those factors described under the heading Risk Factors in CLARIS Annual Report on 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 31, 2022 and those that are included in any of CLEROS' future filings with the SEC. These forward-looking statements speak only as of the date of this call, and CLEROS disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Following the prepared remarks, Clarice will not be taking questions. At this time, I'd like to turn the call over to Dr. Bob Dudley, Founder, President, and Chief Executive Officer of Clarice. Please go ahead, sir.

Thank you. Good afternoon, everyone, and thanks for joining us today. We appreciate your interest in Clarice. With me today is our Chief Financial Officer, Rick Peterson, and our Chief Commercial Officer, Frank Yeager. Now let's get started with our recent business highlights. We continue to see total prescription growth for Jatenzo in the first quarter of 2022, with an increase of 12% sequentially and 75% year-over-year, driven primarily by advertising and promotion and an increase in payer coverage across all payer channels. We presented new data for Jatenzo at the Androgen Society's fourth annual meeting and at the recently concluded 2022 American Urological Association annual meeting just concluding in New Orleans. We plan to submit new data to a peer-reviewed publication, I'm sorry, peer-reviewed medical journal publication in the near future. Notably, these meetings are the first in-person medical meetings where Clarissa has been able to showcase Gitenzo since the start of the COVID pandemic. And next month, we will have a significant presence at the Endocrine Society annual meeting in Atlanta. Again, also, and in-person conference. We received a notice of allowance from the U.S. Patent and Trademark Office for patent claims covering Jatenzo. Once issued, we expect this will be the eighth patent for Jatenzo to be listed in the U.S. Food and Drug Administration's Orange Book. Also on the patent front, we received a notice of allowance from the USPTO for patent claims covering CLAR-121, a proprietary combination of testosterone plus an astrozole delivered by a subcutaneous implant for the treatment of androgen receptor-mediated inflammatory breast disease that occurs predominantly in women. We've also applied for orphan drug designation from the FDA for CLAR-121 for the treatment of inflammatory periodontal mastitis, or PDM, Again, a condition largely expressed in women, and we expect FDA action in June. We also announced the close of an upsized $30 million underwritten public offering, enabling us to continue to promote Jitenzo while extending cash runway into approximately September of 2022. And finally, as noted, we continue to explore strategic alternatives to maximize stockholder value. Now, Rick Peterson, our Chief Financial Officer, will discuss Clarissa's financial status. Rick?

Thank you, Bob. I'll go over the first quarter 22 financial results. In summary, first quarter revenue was $4 million compared to $2.3 million in the same period last year. This represents significant growth to 72% attributed to Gitenzo sales. Gross profit margins was 83% for the first quarter compared to 84% for the prior period. First quarter operating expenses were 16.9 million compared to 12.8 million in the same period last year. This represents an increase of 33% driven by increased sales and marketing activity associated with the promotion of Chitenzo and an increase in general and administrative expenses associated with increased headcount, partially offset by decrease in research and development expenses. So, to break that down, first quarter sales and marketing expenses were $10.7 million compared to $7.9 million in the same period last year. This represents an increase of 35%, again, driven by an increase in advertising and promotional spend associated with Cetenzo. General and administrative expenses were $5.3 million compared to $3.6 million in the same period last year. This represents an increase of 47%, primarily attributable to higher personnel costs and costs associated with being a public company. First quarter research and development expenses were $0.9 million compared to $1.2 million in the same period last year. 27% decrease primarily attributed to just timing of clinical costs associated with JITENSO. Our cash and cash equivalents as of March 31st, 22 were 9.1 million. And then as Bob noted, we did close an upside 30 million underwritten public offering on April 27th, 22, which will fund our current operating plan into approximately September of 22. I will now turn it over to Frank, our Chief Commercial Officer. Frank?