0001654954-23-013131.txt : 20231019 0001654954-23-013131.hdr.sgml : 20231019 20231019080111 ACCESSION NUMBER: 0001654954-23-013131 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20231019 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231019 DATE AS OF CHANGE: 20231019 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PALATIN TECHNOLOGIES INC CENTRAL INDEX KEY: 0000911216 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 954078884 STATE OF INCORPORATION: NJ FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15543 FILM NUMBER: 231333373 BUSINESS ADDRESS: STREET 1: 4B CEDAR BROOK DRIVE CITY: CRANBURY STATE: NJ ZIP: 08512 BUSINESS PHONE: 609-495-2200 MAIL ADDRESS: STREET 1: 4B CEDAR BROOK DRIVE CITY: CRANBURY STATE: NJ ZIP: 08512 FORMER COMPANY: FORMER CONFORMED NAME: INTERFILM INC DATE OF NAME CHANGE: 19930825 8-K 1 ptn_8k.htm FORM 8-K ptn_8k.htm

  

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act Of 1934

 

Date of Report (Date of earliest event reported): October 19, 2023

 

Palatin Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-15543

 

95-4078884

(State or other jurisdiction

 

(Commission

 

(IRS employer

of incorporation)

 

File Number)

 

identification number)

 

4B Cedar Brook Drive, Cranbury, NJ

 

08512

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (609) 495-2200

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

 

Trading Symbol(s)

 

Name of Each Exchange on Which Registered

Common Stock

 

PTN

 

NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 2.02   Results of Operations and Financial Condition.

 

On October 19, 2023, Palatin Technologies, Inc. (the “Company”) issued a press release announcing its preliminary Vyleesi® product revenue for the Company’s first quarter of fiscal year 2024, ended September 30, 2023 (the “Press Release”).  The Vyleesi related financial and operating data for the first fiscal quarter of fiscal year 2024 is preliminary and may change. Additional information that will be material to investors will be provided in the financial statements for the three months ended September 30, 2023, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided in the Press Release.

 

A copy of the Press Release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 8.01   Other Events.

 

On October 13, 2023, the Company issued a press release relating to the matters described in Item 2.02 of this Current Report on Form 8-K, a copy of which is attached hereto as Exhibit 99.1.

 

Item 9.01   Financial Statements and Exhibits.

 

(d) Exhibits:

 

99.1

Press Release dated October 19, 2023

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

Forward-Looking Statements

 

The Company cautions you that statements included in this Current Report on Form 8-K that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

 

 
2

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

PALATIN TECHNOLOGIES, INC.

 

 

 

 

 

Date: October 19, 2023

By:  

/s/ Stephen T. Wills  

 

 

 

Stephen T. Wills, CPA, MST

 

 

 

Executive Vice President, Chief Financial Officer and Chief Operating Officer

 

 

 
3

 

 

EXHIBIT INDEX

 

99.1

Press Release dated October 19, 2023

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
4

 

 EX-99.1 2 ptn_ex991.htm PRESS RELEASE ptn_ex991.htm

EXHIBIT 99.1

 

Palatin Announces Preliminary Quarter Ended

September 30, 2023 Vyleesi® Product Revenue Results

 

·         7 Consecutive Quarters of Double-Digit Growth in Product Revenue and Prescriptions Dispensed

 

·         $4.6 million in Gross Product Revenue

 

o   11% growth over prior quarter; 100% growth over comparable quarter last year

 

·         $2.1 million in Net Product Revenue

 

o    18% growth over prior quarter; 137% growth over comparable quarter last year

 

·         Prescriptions Dispensed

 

o   14% growth over prior quarter; 88% growth over comparable quarter last year

 

CRANBURY, NJ – October 19, 2023 /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 preliminary fiscal year 2024 first quarter ended September 30, 2023 results, for Vyleesi® product revenue. Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

 

“We are pleased with Vyleesi’s quarterly growth in all key operating and distribution metrics,” stated Carl Spana, Ph.D., President and CEO of Palatin. “We continue to successfully execute our commercial strategy, as evidenced by seven consecutive quarters of double-digit profitable growth. Importantly, net revenue per prescriptions dispensed continues to improve, and quarterly net product revenue for Vyleesi continues to grow and exceed Vyleesi quarterly operating expenses.”

 

·

 Preliminary Vyleesi product revenue results for the fiscal year 2024 first quarter ended September 30, 2023:

 

 

■

Gross product revenue was $4.6 million, an 11% increase over the prior quarter, and a 100% increase over the comparable quarter last year.

 

 

 

 

■

Net product revenue was $2.1 million, an 18% increase over the prior quarter, and a 137% increase over the comparable quarter last year.

 

 

 

 

■

Prescriptions dispensed increased 14% and 88% over the prior quarter and comparable quarter last year, respectively.

 

 

 

 

■

All key operating and commercial metrics, including new patient starts, refill rates, commercial insurance reimbursement, net revenue per prescription dispensed, and new healthcare prescribers, continued with positive and impactful results and trends, versus the prior quarter, and comparable quarter last year.

 

 
1

 

 

Preliminary Financial Information

 

The Vyleesi related financial and operating data for the first fiscal quarter of 2024 is preliminary and may change. This preliminary data has been prepared by, and is the responsibility of, Palatin’s management and no independent accounting firm has audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial data. There can be no assurance that Palatin’s actual results for this quarterly period will not differ from the preliminary financial and operating data and such changes could be material. In addition, Palatin’s estimate of Vyleesi product revenues for the quarter ended September 30, 2023 should not be viewed as a substitute for full financial statements prepared in accordance with U.S. generally accepted accounting standards. Additional information that will be material to investors will be provided in the financial statements for the three months ended September 30, 2023, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided herein.

 

About Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)

 

Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD.

 

Palatin is actively seeking Vyleesi collaborations for the United States and for territories outside the currently licensed territories of China and South Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea.

 

Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

 

About Palatin

 

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with 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.

 

 
2

 

 

Forward-looking Statements

 

Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about Vyleesi results and potential market, 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, 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 events that occur after the date of this press release.

 

Investor Inquiries:

 

Media Inquiries:

Stephen T. Wills, CPA, MST

 

Paul Arndt, MBA, LifeSci Advisors

CFO/COO (609) 495-2200

 

Managing Director (646) 597-6992

Info@Palatin.com

 

Paul@LifeSciAdvisors.com

 

Palatin Technologies® and Vyleesi® are registered trademarks of Palatin Technologies, Inc.

 

###

 

 
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