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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Palatin Technologies Inc New | AMEX:PTN | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
-0.05 | -2.44% | 2.00 | 2.165 | 2.01 | 2.10 | 553,607 | 00:06:24 |
CRANBURY, N.J., Sept. 22, 2022 /PRNewswire/ -- 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, today announced financial results for its fiscal fourth quarter and fiscal year ended June 30, 2022.
"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."
All share and per share amounts are presented on a post-reverse-split basis, giving effect to the 1- for-25 reverse stock split.
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.
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.
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.
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.
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.
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.
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 http://www.palatin.com. 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.
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.
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with highly potent, targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about market potential of Vyleesi and other Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, Palatin's ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.
PALATIN TECHNOLOGIES, INC. | ||||||||
and Subsidiary | ||||||||
Consolidated Statements of Operations | ||||||||
(unaudited) | ||||||||
Three Months Ended June 30, | Year Ended June 30, | |||||||
2022 | 2021 | 2022 | 2021 | |||||
REVENUES | ||||||||
Product revenue, net | $ 770,738 | $ 80,504 | $ 1,218,457 | $ (283,286) | ||||
License and contract | - | 94,689 | 250,000 | 94,689 | ||||
Total revenues | 770,738 | 175,193 | 1,468,457 | (188,597) | ||||
OPERATING EXPENSES | ||||||||
Cost of products sold | 87,517 | 37,800 | 217,529 | 147,840 | ||||
Research and development | 7,436,199 | 3,481,800 | 21,327,434 | 12,926,559 | ||||
Selling, general and administrative | 6,348,112 | 5,950,339 | 16,511,942 | 17,336,913 | ||||
Loss on license termination agreement | - | 4,407,987 | - | 2,784,192 | ||||
Total operating expenses | 13,871,828 | 13,877,926 | 38,056,905 | 33,195,504 | ||||
Loss from operations | (13,101,090) | (13,702,733) | (36,588,448) | (33,384,101) | ||||
OTHER INCOME (EXPENSE) | ||||||||
Investment income | 25,863 | 3,803 | 29,963 | 23,572 | ||||
Foreign currency gain (loss) | 325,868 | (221,274) | 389,868 | (212,526) | ||||
Interest expense | (18,259) | (14,080) | (29,682) | (23,440) | ||||
Total other income (expense), net | 333,472 | (231,551) | 390,149 | (212,394) | ||||
NET LOSS | $ (12,767,618) | $ (13,934,284) | $ (36,198,299) | $ (33,596,495) | ||||
Basic and diluted net loss per common share | $ (1.34) | $ (1.47) | $ (3.79) | $ (3.55) | ||||
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 9,543,762 | 9,481,910 | 9,543,762 | 9,466,004 |
PALATIN TECHNOLOGIES, INC. | |||
and Subsidiary | |||
Consolidated Balance Sheets | |||
(unaudited) | |||
June 30, 2022 | June 30, 2021 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 29,939,154 | $ 60,104,919 | |
Accounts receivable | 1,780,020 | 1,580,443 | |
Inventories | 944,471 | 1,162,000 | |
Prepaid expenses and other current assets | 1,932,454 | 3,059,679 | |
Total current assets | 34,596,099 | 65,907,041 | |
Property and equipment, net | 539,314 | 94,817 | |
Right-of-use assets - operating leases | 878,465 | 1,237,813 | |
Other assets | 56,916 | 56,916 | |
Total assets | $ 36,070,794 | $ 67,296,587 | |
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 3,157,617 | $ 640,650 | |
Accrued expenses | 6,875,216 | 5,797,378 | |
Short-term operating lease liabilities | 371,124 | 351,853 | |
Short-term finance lease liabilities | 100,921 | - | |
Other current liabilities | 5,754,986 | 3,721,907 | |
Total current liabilities | 16,259,864 | 10,511,788 | |
Long-term operating lease liabilities | 529,398 | 900,520 | |
Long-term finance lease liabilities | 152,407 | - | |
Other long-term liabilities | 2,861,250 | 6,232,907 | |
Total liabilities | 19,802,919 | 17,645,215 | |
Series B and Series C Redeemable Convertible Preferred Stock of $0.01 par value: authorized, issued, and outstanding 9,000,000 shares as of June 30, 2022, with a liquidiation preference of $15,000,000 | 15,000,000 | - | |
Escrowed proceeds | (15,000,000) | - | |
Stockholders' equity: | |||
Preferred stock of $0.01 par value – authorized 10,000,000 shares (including amounts authorized for | |||
Series B and Series C Redeemable Convertible Preferred Stock): shares issued and outstanding | |||
designated as follows: | |||
Series A Convertible: authorized 4,030 shares as of June 30, 2022: issued and outstanding 4,030 shares | |||
as of June 30, 2022 and June 30, 2021 | 40 | 40 | |
Common stock of $0.01 par value – authorized 300,000,000 shares: | |||
issued and outstanding 9,270,947 shares as of June 30, 2022 and 9,201,988 shares as of June 30, 2021 | 92,709 | 92,020 | |
Additional paid-in capital | 404,168,822 | 401,354,709 | |
Accumulated deficit | (387,993,696) | (351,795,397) | |
Total stockholders' equity | 16,267,875 | 49,651,372 | |
Total liabilities, redeemable convertible preferred stock, and stockholders' equity | $ 36,070,794 | $ 67,296,587 |
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SOURCE Palatin Technologies, Inc.
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