Clarus Therapeutics Holdings, Inc.

Ladies and gentlemen today's conference is scheduled to begin shortly. Please continue to stand by and thank you for your patience. Thank you. Thank you. Hello. Thank you for joining the CLRS Third Quarter 2021 Financial Results Conference Call. Today's call is being recorded and webcast live on the company's website, at www.clairstherapeutics.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. Forward-looking statements involve a number of risks and uncertainties, some of which are beyond Clery's control, or other assumptions that may cause actual results or performance to be material or different from those expressed or implied by these forward-looking statements. These risks and uncertainties include but are not limited to the risk association with the pharmaceutical development, risk association with Clery's financial position, and those factors described under the heading Risk Factors in the Prospective Files with the Securities and Exchange Commission, the SEC, under Rule 424B3 on October 7, 2021, and those that are included in any of Clarence's future filings with the SEC, including the 10-Q. These forward-looking statements speak only as the date of this call, and Clarence disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements expect except as may be required by law. Following the prepared remarks, Clarence will take your questions. At this time, I'd like to turn the call over to Dr. Bob Dudley, President and Chief Executive Officer of Clarence. Sir, you may begin.

Thank you. Good afternoon and good evening, everyone. Thank you for joining us today for a very exciting milestone in Clarence's history, that is being a publicly traded company. and I want to say publicly we appreciate your interest in Claris. With me today is our Chief Financial Officer, Rick Peterson, our Chief Commercial Officer, Frank Yeager. Also on the line is our Chief Administrative Officer, Steve Bourne. Let me get started with some recent highlights from the business. We closed the transaction between Blue Water and Claris Therapeutics and debuted as a publicly traded company to develop androgen and metabolic therapies for men and women. Our first day of trading was September 10th, 2021, and we currently trade on the NASDAQ Global under the CRXT ticker. We're very proud to have accomplished this transaction, and I want to thank everyone involved for all of the work they've put in to make this transaction a success. Other business highlights, we received two notices of allowance from the US Patent and Trademark Office covering Gitenzo. Upon issuance of these patents, which will be listed in the orange book, this will bring the total number of orange book patents listed protecting Gitenzo to seven. Additionally, we entered into an exclusive worldwide license agreement with McGill University, Canadian's top-ranked medical doctoral university, to develop and commercialize technology to treat conditions associated with CoQ10 or ubiquinone deficiencies. We also entered into an exclusive license agreement with Hava Therapeutics, an Australia-based biopharmaceutical company developing androgen therapies for inflammatory breast disease, principally in women, and also a common form of breast cancer, also principally in women, but afflicting men as well. Next, we announced a comprehensive settlement of patent litigation with Lifesim that resolved all outstanding claims against CLARIS and with payments to CLARIS as part of that settlement. And finally, we experienced total prescription growth for Jitenzo in the third quarter of 2021 with an increase of 12% sequentially and 132% year over year. With those brief highlights, I will now turn the podium over to Rick Peterson, our Chief Financial Officer, to discuss financial highlights. Thank you, Bob. Over the financial results for the three months ended September 30th, 2021 are as follows. Net product revenue of approximately $4.3 million and a net loss of $0.26 per share, both basic and diluted assets. as we were in a loss position. Revenue growth represents a year-over-year increase of 93% driven by the growth of the Detenzo brand through our sales and marketing efforts. Frank will be talking in more detail about Detenzo in a few minutes. Gross profit margins were approximately 88% for both quarters ending September of 21 and September of 2020. Sales and marketing expenses were approximately $7.6 million, compared to $8.7 million for the comparable quarter of 2020. This represents a year-over-year decrease of approximately 13.3%, primarily attributable to timing of sales and marketing expenses, such as media buys and agency fees that we run. General and administrative expenses were approximately $3.4 million, compared to 0 million for the comparable quarter of last year. This represents a year-over-year increase of approximately 11.3%, primarily attributable to personnel costs, external consultants, and other general corporate expenses. R&D expenses were approximately 1.3 million for the third quarter. This represents a year-over-year decrease of approximately 11.3% due to a decrease in R&D consulting services offset by an increase in license fees. We paid license fees to our third parties with HAVA and McGill. Both those agreements, license agreements for R&D projects were signed in the nine months of this year. Total cash and cash equivalents were approximately 22 million at quarter end. And our weighted average common share is outstanding For calculating net loss and income per common share, we're at $9.2 million. So that's the financial highlights. At this point, I'll turn it over to Frank to cover the Gitenzo grant highlights.

Thank you, Rick, and thank you, Bob. It is a pleasure to be here today to give the public a high-level commercial overview. So let's just jump right in. This has been an exciting time for Clarissa. Gitenzo has experienced several notable milestones in the third quarter as the brand continues to grow. First, let me give you some clarity on performance. Despite the COVID pandemic timing and the associated challenges that we continue to face, we continue to see that Gitenzo is gaining momentum as prescriptions have increased steadily throughout the year. Our prescription growth has been driven by several things. Expanded reach and frequency by our sales team to targeted healthcare providers. Increased sales rep access to prescriber offices and success with being able to reach and educate the prescriber virtually when live calls aren't possible. More patients returning to healthcare provider offices, which is a trend that we expect to continue. Increased overall payer coverage across all channels of our business. continued success of our Jitenzo co-pay assistance program, and finally, continued positive feedback that we've received from prescribers and patients regarding their experiences with Jitenzo. So second, I am pleased to showcase that we have presented at the Sexual Medicine Society of North America meeting this past month. On October 21st, we presented an abstract on our real-world Jitenzo experience data. That data showcased that Jitenzo can be dose-adjusted to reach the targeted testosterone levels that a healthcare provider is trying to achieve. This flexibility is important because, as we know, healthcare providers value the ability to customize treatment to achieve the individualized therapeutic response for each patient. We believe that ability to manage hypogonadal symptoms with individualized dosing is important to the provider, as this is consistent with current medical practice may increase patient satisfaction and ultimately result in better patient adherence, which is a very common issue associated with testosterone replacement therapy. We anticipate submitting this data and other data, not covered in the abstract, at upcoming medical congresses and into a peer-reviewed medical journal for publication in the coming months. And finally, we have positioned ourselves for continued growth by increasing the number of our sales force to 60 representatives, in order to continue to expand our reach in the market to targeted healthcare providers. So, in summary, we believe Chitenzo is poised for continued and accelerated growth, as we know that the testosterone replacement therapy market is large, with about, you know, approximately 8 million prescriptions written in this market each year. And it continues to grow year over year. In fact, the market achieved over 7% growth in 2020 over 2019, despite COVID. Okay. We also know that roughly three out of every four patients are not satisfied with their current non oral therapy. This is a large number considering that there are about 2.2 million patients who are currently being treated with an additional 4 million patients who have either been diagnosed or have stopped treatment. These patients collectively represent our opportunity because as an oral, Jitenzo overcomes the significant administration issues associated with the injections and the gels, where a majority of the prescriptions are written today. In fact, 80% of all patients are interested in learning about an oral such as Jitenzo. As we move forward into 2022, we intend to continue to invest additional resources to educate healthcare providers and their patients that they serve through strategic use of targeted promotional programs, and by expanding the sales force. So at this point, I will turn it over to Bob, who will provide some updates on the pipeline for Claris. Bob? Thank you, Frank.