11/14/2023

speaker
Operator
Conference Call Operator

Greetings. Welcome to Palatine's first quarter fiscal year 2024 operating results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects. Now I would like to turn the call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead.

speaker
Dr. Carl Spana
President and Chief Executive Officer, Palatin

Thank you. Good morning and welcome to the Palatin First Quarter Fiscal Year 2024 call. I'm Dr. Carl Spana, the CEO and President of Palatin. With me on the call today is Steve Wills, Palatine's Executive Vice President, Chief Financial Officer, and Chief Operating Officer. I'll now turn the call over to Steve, and he'll give the financial and operating update. Steve. Thank you, Carl.

speaker
Steve Wills
Executive Vice President, Chief Financial Officer and Chief Operating Officer, Palatin

Welcome, everyone. Regarding non-financial highlights for our commercial product, Vilisi, which is approved for premenopausal women, for the treatment of HSDD, which stands for hypoactive sexual desire disorder. As we've mentioned prior, the goal is to demonstrate commercial product value in the marketplace with an objective of relicensing the U.S., possibly even the global rights, to a committed women's healthcare company. Palatin's licensee of Elysian China, Fosun Pharma, reported its first sale in the Hunan province of China. Palatin's licensee of Ilesi in South Korea, Kwondong Pharmaceuticals, completed enrollment in its Phase III clinical trial evaluating the efficacy and safety of Ilesi in premenopausal women with HSD day. Data is currently anticipated by calendar year end 2023 with a potential regulatory submission in the first half of calendar 2024. Palatin entered a strategic partnership with Upscripts Health, a leading direct-to-consumer telemedicine company providing telemedicine services to pharmaceutical and medical technology companies. Regarding operations specific to Vilesi, for the fiscal first quarter ended September 30, 2023, gross product sales of $4.6 million increased 11% over the prior quarter and increased 100% over the comparable quarter last year. Net product revenue of 2.1 million increased 20% over the prior quarter and increased 142% over the comparable quarter of last year. Total prescriptions dispensed increased 14% over the prior quarter and increased 88% over the comparable quarter of last year. Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed continued with positive and impactful results and trends versus the prior quarter and comparable quarter last year. Bilesi reported its seventh consecutive quarter of double-digit growth across all metrics, both significant and some not as significant. Importantly, Bilesi's quarterly net product revenue continues to exceed Bilesi quarterly operating expenses. Moving over to overall, Operations for the fiscal, for the first quarter ended September 30th, 2023. Regarding revenue, total revenue consists of gross product sales of Vilesi, net of expenses, allowances and accruals, and license and contract revenue. As I mentioned, Vilesi gross product sales to pharmacy distributors for the quarter ended September 30th, 2023 were 4.6 million, with net product revenue of 2.1 million. This compared to gross product sales of 2.3 million, and it looks like it was a double, and net product revenue of a little under $1 million for the comparable quarter last year. Gross product sales increased 100%. Yeah, that'd be a double. And net product revenue increased 142% over the comparable quarter of last year. Regarding operating expenses, total operating expenses were $8.2 million for the quarter ended September 30th, 2023, compared to $9.6 million for the comparable quarter last year. The decrease in operating expenses was mainly related to the overall decrease in expenses on our MC programs and secondarily to the overall decrease in selling expenses related to by leasing and to a certain extent the reduction in cost of products sold due to the sale of fully reserved by leasing inventory. Regarding cash flows, Paliton's net cash use and operations for the quarter ended September 30th, 2023 was 5.9 million compared to net cash use and operations of 8.6 million for the same period in 2022. The decrease in net cash used in operations is mainly due to a decrease in net loss offset by working capital changes. Regarding net loss, Palletson's net loss for the quarter ended September 30, 2023 was $5.9 million or $0.48 per basic and diluted common share compared to a net loss of $8.3 million or $0.86 per basic and diluted common share for the same quarter in 2022. Excuse me, I have a little bit of a lingering cough. Regarding cash position, as of September 30, 2023, Palatine's cash, cash equivalents, and marketable securities were approximately $5.5 million plus $1.3 million of accounts receivables compared to $11 million plus $2.9 million of accounts receivables as of June 30, 2023. This $5.5 million of cash, cash equivalents, and marketable securities as of September 30, 2023 does not include $4.5 million of net proceeds from the Registered Direct Offering, which closed in October 2023. We believe that existing cash, cash equivalents, marketable securities, and accounts receivables will be sufficient to fund currently anticipated operating expenses and disbursements into the first half of calendar year 2024. Now I'll turn it back over to Carl.

Disclaimer

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