On September 22, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, reported financial results for its fiscal fourth quarter and fiscal year ended June 30, 2022 (Press release, Palatin Technologies, SEP 22, 2022, View Source [SID1234621352]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are excited to have two novel melanocortin receptor peptides with differentiating product profiles progressing in clinical trials – a Phase 3 pivotal study of PL9643 in patients with dry eye disease, and a Phase 2 clinical study of oral PL8177 in patients with ulcerative colitis," stated Carl Spana, Ph.D., President and CEO of Palatin. "Topline results from the Phase 3 study of PL9643 is currently expected in the second quarter calendar of 2023, and the interim analysis and topline results from the Phase 2 study of PL8177 currently expected in the first half of 2023."
Dr. Spana further commented, "Vyleesi sales continue to grow, with our June 30, 2022, quarter showing significant increases across all value metrics, including gross product sales, net product revenue, prescriptions dispensed, refill rates, and commercial insurance reimbursement, compared to the prior quarter and comparable quarter last year."
Financial Highlights for the Fourth Quarter Ended June 30, 2022
Net loss for the quarter ended June 30, 2022, was $12.8 million, or $(1.34) per common share, compared to a net loss of $13.9 million, or $(1.47) per common share, for the same period in 2021.
As of June 30, 2022, the Company had cash and cash equivalents of $29.9 million, compared to $37.7 million as of March 31, 2022 and $60.1 million as of June 30, 2021.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Gross product sales increased 79%, net product revenue increased 257% and prescriptions dispensed increased 49%, over the prior quarter.
Business Highlights and Recent Updates
Anti-Inflammatory / Autoimmune Programs
PL9643 melanocortin agonist for the treatment of dry eye disease (DED)
Positive interim analysis in ongoing Pivotal Phase 3 clinical study in patients with DED.
The independent data monitoring committee (DMC) performed their assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll up to an additional 230 patients in the study for a final sample size of 350 patients.
No safety concerns were identified by the DMC.
Topline data readout expected in the second quarter of calendar year 2023.
Additional trial information, including inclusion and exclusion criteria, can be found at View Source via the identifier NCT04268069.
PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC):
Initiated patient recruitment in a Phase 2 oral formulation study of PL8177 in patients with UC.
Interim assessment is currently expected to occur in the first quarter of calendar year 2023.
Topline data readout is currently expected in the second quarter of calendar year 2023.
Additional trial information, including inclusion and exclusion criteria, can be found at View Source via the identifier NCT05466890.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate commercial product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.
For the fiscal fourth quarter ended June 30, 2022:
Gross product sales increased 79% over the prior quarter, increased 91% over the comparable quarter in 2021.
Net product revenue increased 257% over the prior quarter, increased 857% over the comparable quarter in 2021.
Total prescriptions dispensed increased 49% over the prior quarter, increased 54% compared to the comparable quarter in 2021.
Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed, increased over the prior quarter and comparable quarter in 2021.
Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com
Other:
Redeemable Convertible Preferred Stock: On May 11, 2022, Palatin entered into a securities purchase agreement with institutional investors, selling and issuing 8,100,000 shares of Series B Redeemable Convertible Preferred Stock ("Series B Preferred Stock") and 900,000 shares of Series C Redeemable Convertible Preferred Stock ("Series C Preferred Stock"). Each share of Series B Preferred Stock and Series C Preferred Stock had a purchase price of $1.67 and is convertible into Palatin common stock at an initial conversion price of $11.25 per share. The investors in the Series B Preferred Stock and Series C Preferred Stock also received warrants to purchase up to 66,666 shares of common stock at an exercise price of $12.50 per share, which expire 48 months following issuance. Total gross proceeds from the offering, before deducting offering expenses, is $15.0 million which was deposited in, and is being held in, an escrow account as of June 30, 2022, pending the investors’ election to redeem the shares for cash or in notes, or convert the shares to common stock. The escrowed proceeds have been presented as a deduction to Series B and C Redeemable Convertible Preferred Stock on the Company’s consolidated balance sheet at June 30, 2022.
To the extent any shares of Series B Preferred Stock or Series C Preferred Stock are converted to common shares or redeemed for debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes. Additional information regarding the securities described above and the terms of the offering are included in Palatin’s fiscal year ended June 30, 2022 10-K filing with the United States Securities and Exchange Commission.
Reverse Stock Split: At Palatin’s Annual Meeting of Stockholders held on June 24, 2022, the Company’s stockholders approved the amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s common stock. The Board of Directors approved the implementation of a 1-for-25 reverse stock split effective as of 5:00 p.m. Eastern Time on August 30, 2022. The reverse stock split reduced the number of shares of Palatin’s common stock outstanding from approximately 231,774,000 shares to approximately 9,271,000 shares but did not change the authorized number of shares of Common Stock, which remain at 300,000,000 shares of Common Stock. The Company’s common stock continues to trade on the NYSE American Stock Market under the symbol "PTN."
Fourth Quarter and Fiscal Year Ended June 30, 2022 Financial Results
All share and per share amounts are presented on a post-reverse-split basis, giving effect to the 1- for-25 reverse stock split.
Revenue
Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals, and license and contract revenue.
Vyleesi gross product sales to pharmacy distributors for the quarter ended June 30, 2022, were $2.3 million, with net product revenue of $770,738, compared to gross product sales of $1.2 million, with net product revenue of $80,504, for the comparable quarter in 2021. Gross product sales increased 91% and net product revenue increased 857% over the comparable quarter in 2021.
Vyleesi gross product sales to pharmacy distributors for the fiscal year ended June 30, 2022, were $5.8 million, with net product revenue of $1.2 million, compared to gross product sales of $4.7 million, with negative net product revenue of $283,286, for the fiscal year ended June 30, 2021. Gross product sales increased 23% and net product revenue increased 530% over the fiscal year ended June 30, 2021.
Palatin recognized $250,000 in license and contract revenue for the fiscal year ended June 30, 2022, related to our license agreement with Fosun, compared to $94,689 for the quarter and fiscal year ended June 30, 2021, related to our license agreement with Kwangdong.
Operating Expenses
Total operating expenses were $13.9 million for the quarters ended June 30, 2022 and 2021.
Total operating expenses for the fiscal year ended June 30, 2022, were $38.1 million, compared to $33.2 million for the fiscal year ended June 30, 2021.
The increase in operating expenses was the result of increased research and development expenses primarily related to our ongoing pivotal Phase 3 clinical trial of PL9643, offset by decreased commercial expenses related to Vyleesi.
Other Income / (Expenses)
Total other income, net, consist mainly of unrealized foreign currency transaction gains and losses, which consisted of gains of $325,868 and $389,868, respectively, for the quarter and fiscal year ended June 30, 2022, compared to losses of $221,274 and $212,526, respectively, for the quarter and fiscal year ended June 30, 2021.
Cash Flows
Palatin’s net cash used in operations for the quarter and fiscal year ended June 30, 2022, was $7.7 million and $29.9 million, respectively, compared to net cash used in operations of $8.5 million and $22.6 million, respectively, for the same periods in 2021. The increase in net cash used in operations is mainly due to cash received in fiscal year ended June 30, 2021 related to our Termination Agreement with AMAG Pharmaceuticals offset by a one-time negotiated payment of approximately $7.0 million in the quarter ended December 31, 2020 related to inventory purchase commitments of Vyleesi and by increased operating expenses in fiscal year ended June 30, 2022.
Net Loss
Palatin’s net loss for the quarter and fiscal year ended June 30, 2022, was $12.8 million and $36.2 million, or $(1.34) and $(3.79) per basic and diluted common share, respectively, compared to a net loss of $13.9 million and $33.6 million, or $(1.47) and $(3.55) per basic and diluted common share, respectively, for the same periods in 2021.
The decrease in net loss for the quarter ended June 30, 2022 over the quarter ended June 30, 2021, was mainly due to the increase of net product revenue of Vyleesi. The increase in net loss for the fiscal year ended June 30, 2022 over the fiscal year ended June 30, 2021, was mainly due to increased operating expenses offset by increased Vyleesi total revenues.
Cash Position
As of June 30, 2022, Palatin’s cash and cash equivalents were $29.9 million with $1.8 million of accounts receivable, compared to cash and cash equivalents of $37.7 million with $0.8 million of accounts receivable as of March 31, 2022, and $60.1 million of cash and cash equivalents with $1.6 million of accounts receivable as of June 30, 2021.
The $29.9 million of cash and cash equivalents at June 30, 2022, does not include the $15 Million Private Placement of Redeemable Convertible Preferred Stock. These funds are being held in an escrow account, pending the investors’ election to redeem the shares for cash or in notes, or convert the shares to common stock.
Palatin’s audited financial statements for the year ended June 30, 2022, to be included in the Annual Report on Form 10-K include an audit report from its independent registered public accounting firm, KPMG LLP, that contains a going concern explanatory paragraph.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on September 22, 2022 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-458- 4121 (US/Canada) or 1-313-209-6672 (International), conference ID 8655999. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1- 719-457-0820 (International), passcode 8655999. The webcast and telephone replay will be available through September 29, 2022.
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.