5/1/2025

speaker
Operator
Conference Call Moderator

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the TARCIS first quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. If you would like to ask a question at that time, please press star 1-1 on your telephone keypad. As a reminder, this conference call is being recorded. At this time, I would like to turn the conference over to Mr. David Nakasone. Sir, please begin.

speaker
David Nakasone
Investor Relations Representative

Thank you. Before we begin, I encourage everyone to go to the investor section of the TARCIS website to view the earnings release and related materials we will be discussing today. Joining me on the call this afternoon are Bobby Azamian, our Chief Executive Officer and Chairman, Aziz Motawala, our Chief Commercial Officer, Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer, and joining us for the question and answer session, Faysha Nirvana, our Chief Operating Officer. I'd like to draw your attention to slide three, which contains our forward-looking statements. During this call, we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional details. With that, I'll turn the call over to Bobby.

speaker
Bobby Azamian
Chief Executive Officer and Chairman

Thank you, Dave. Good afternoon, everyone, and thank you for joining us. 2025 is off to a tremendous start in terms of both patient impact and the exceptional sales growth of Xtembi. I am pleased to share that in the first quarter, we generated more than $78 million in Xtembi sales, a year-over-year increase of 217%, driven by approximately 72,000 bottles that were dispensed to patients. The results we have delivered to date demonstrate the impressive executional ability of our team to establish an entirely new market and foster its growth. They also highlight the difference in positive impact we can have on the millions of patients we aim to serve on our way to becoming an eye care leader. Aziz will provide more specifics on our commercial achievements this quarter, future plans for our innovative DTC campaign, and the team's ongoing efforts to build even more momentum. Having just come back from visiting doctors in Cincinnati, I wanted to share my personal perspective on how different it is to be in the field today versus a year ago or even a quarter ago. MDs and ODs are looking for more DB patients and beginning to prescribe Xtemvi across all DB patient segments of MGD, dry eye, cataracts, and contact lenses. They are now fully empowered by the high-quality access we've secured across all payer channels and our high-touch patient services that ensure patients can receive XtemV at a reasonable cost. And patients are beginning to ask about DV after seeing our unique and action-oriented DPC campaign. I also heard from several of the ECPs I visited that XtemV is one of the best advances they've seen in decades. and has become their new standard of care. It is clear our growth drivers are having a significant impact as our target physicians are rapidly moving from monthly to weekly to daily prescribing. And we strongly believe we are just beginning to scratch the surface on the maximum prescribing potential for all of our riders. Now, while our immediate focus remains on the U.S. launch of Xenvi, We are also continuing to explore the global potential of Xembi and pursuing our next category creating opportunity, ocular rosacea. We recently presented meaningful new data at the American Society of Cataract and Refractive Surgery, or ASCRS, which showed that the high prevalence and significant impact of demonyx blepharitis in Japan is on par with the U.S. That is, there are millions of people in Japan suffering from demodex blepharitis and in need of XtemV. We are confident about the potential opportunity here and look forward to meeting with regulatory authorities in the second half of this year to determine our best path forward in this region. We are also making great progress in Europe. As a reminder, due to the stellar clinical data and product profile of XtemV, the European Medicines Agency has stated we do not need to conduct a Phase III study, and we remain on track for potential European regulatory approval in 2027. Turning to ocular rosacea, the more we learn about this pervasive and damaging eye disease, the more excited we are about its potential to be the next transformative category in eye care. we are consistently hearing from ECPs that they are seeing as much ocular rosacea in their practices as DB, and that it may be even more impactful to their patients in terms of how they look, feel, and see. Like DB, ocular rosacea is a large and underserved market that affects approximately 15 to 18 million Americans, with the majority of cases caused by an infestation of demodex mites, It can also be quickly and simply diagnosed in any standard eye exam by looking for inflammation and redness. And these are just a couple of the many parallels to demonyx blepharitis that give us great confidence in our ability to deliver another impactful therapeutic that targets the root cause of disease. The potential medicine we are advancing is TP04, a convenient, sterile, ophthalmic gel formulation of our best-in-class molecule, Lodolanum. It is specifically designed to be used around the eye, and the ECPs we have spoken with are excited about this approach. We are accelerating this program as quickly as possible and remain on track to initiate a Phase II trial later this year. Finally, I'd like to highlight our recent equity financing, which secured approximately $135 million, no small feat in the current market environment. The significant support that our existing and new shareholders demonstrated through their participation in this upsized equity offering speaks to the confidence they have in the potential value of Xtemvi and our pipeline. These funds further strengthen our financial position and will enable us to continue to drive the growth of Xtemvi, potentially create another new category in ocularization, and continue to advance our pipeline. There is clearly a lot to be excited about. We have a proven category creating blueprint for success. We are advancing a pipeline of category creating medicines that could potentially be the standard of care. And we believe that we are well positioned to achieve substantial and sustained revenue growth for years to come. With that, I will turn the call over to Aziz.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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