5/5/2021

speaker
Operator
Conference Call Operator

Good day, and thank you for standing by. Welcome to the I-Point first quarter 2021 financial results 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. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, George Elston, Chief Financial Officer. Please go ahead.

speaker
George Elston
Chief Financial Officer

Thank you, and thank you all for joining us on today's conference call to discuss iPoint Pharmaceutical's first quarter to 2021 financial results and recent corporate developments. With me today is Nancy Lurker, President and Chief Executive Officer of Dr. Jay Duker, Chief Strategic Scientific Officer, and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates. Dr. Duker will then discuss pipeline developments for EYP 1901, and Scott will comment on our commercial business performance. I will close with commentary on the first quarter 2021 financial results, and we will then open the call up for your questions. Earlier this morning, we issued a press release detailing our financial results as well as commercial and operational developments. A copy of the release can be found in the Investor Relations tab on the corporate website, www.ipointspharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and our plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section on our most recent annual report on Form 10-K, which is on file with the SEC. and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of iPoint Pharmaceuticals.

speaker
Nancy Lurker
President and Chief Executive Officer

Thank you, George. Good morning everyone and thank you for joining us. We are incredibly pleased with our progress this quarter with both our paradigm changing pipeline and our commercial products that are delivering innovation to patients with serious ophthalmic diseases. Before turning the call over to my colleagues, I will briefly review our recent achievements as we continue to make terrific progress on our clinical and commercial plans. On the clinical front, In January, we initiated our Phase I DAVIO trial for our lead pipeline asset, EYP1901, a potential twice-yearly treatment for wet age-related macular degeneration, or wet AMD. And we remain on track with this trial. As a reminder, EYP1901 leverages a bioerodible formulation of our proprietary Duracert sustained release technology with Virolineb, an anti-VEGF tyrosine kinase inhibitor. We are very much looking forward to providing further updates with preliminary data from the DAVIO study expected in the fourth quarter of this year. In February, we continue to strengthen our balance sheet after the successful completion of an oversubscribed 115.1 million follow-on offering. This financing provides us with significant capital. to continue to grow our organization efficiently and purposefully, including plans to expand our pipeline by initiating studies in additional indications for EYP1901 in diabetic retinopathy and retinal vein occlusion, as well as advancing UTIC 5.0 for posterior segment uveitis. Right now, we hope to begin these studies sometime in late 2021 or early 2022. Our improved balance sheet provided us the opportunity to work with our debt partner, CRG, on improving our revenue covenant. I'm happy to say that we were able to obtain a reduction in the 2021 revenue covenant with CRG to $25 million at no cost. Turning to our commercial business, despite the challenges of the COVID-19 pandemic, we are pleased to report a strong first quarter of 2021 with net product revenues of $6.8 million a 45% increase over Q1 of 2020. As Scott will discuss in more detail later on, although historically demand is slowest in the first calendar quarter across all commercial products, we were pleased with the continued return of customer demand. Also this quarter, we introduced a new siliconized needle for UTIC, which we will believe will provide an enhanced experience for patients and physicians in administering UTIC to patients. Lastly, our Asia partner, OccuMention Therapeutics, recently received approval for review of a new drug application from the National Medical Products Administration, or NMPA, in China for OT401, which is named UT in the U.S. This is an exciting milestone for UT as it represents a safe, effective treatment option for patients in China and a future royalty stream for iPoint. I point into the quarter in a strong position, and we are focused on carrying our very positive momentum into the second quarter of 2021 and beyond. Additionally, as we look to provide preliminary data for our EYP1901 Phase 1 trial in the fourth quarter of this year, we are now focused on, one, expanding our product pipeline, two, driving growth for our commercial products with a goal of DEXA-Q AUT, achieving franchise profitability by year-end, and three, continue to maintain a strong balance sheet through disciplined spending. I'll now turn the call over to Dr. Jay Duker, our Chief Strategic Scientific Officer, to provide an update on our lead program, EYP 1901, as well as other pipeline initiatives. Jay?

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.

-

-