0001558370-23-011769.txt : 20230710 0001558370-23-011769.hdr.sgml : 20230710 20230710080514 ACCESSION NUMBER: 0001558370-23-011769 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230710 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230710 DATE AS OF CHANGE: 20230710 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AYTU BIOPHARMA, INC CENTRAL INDEX KEY: 0001385818 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 470883144 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38247 FILM NUMBER: 231078268 BUSINESS ADDRESS: STREET 1: 373 INVERNESS PARKWAY STREET 2: SUITE 206 CITY: ENGLEWOOD STATE: CO ZIP: 80112 BUSINESS PHONE: (720) 437-6580 MAIL ADDRESS: STREET 1: 373 INVERNESS PARKWAY STREET 2: SUITE 206 CITY: ENGLEWOOD STATE: CO ZIP: 80112 FORMER COMPANY: FORMER CONFORMED NAME: AYTU BIOSCIENCE, INC DATE OF NAME CHANGE: 20150609 FORMER COMPANY: FORMER CONFORMED NAME: AYTU BIOSCIENCE, INC. DATE OF NAME CHANGE: 20150609 FORMER COMPANY: FORMER CONFORMED NAME: Rosewind CORP DATE OF NAME CHANGE: 20070110 8-K 1 aytu-20230710x8k.htm 8-K
0001385818false00013858182023-07-102023-07-10

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): July 10, 2023

AYTU BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware

   

001-38247

   

47-0883144

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

373 Inverness Parkway, Suite 206

Englewood, CO 80112

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (720) 437-6580

N/A

(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:

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, par value $0.0001 per share

AYTU

The NASDAQ Stock Market LLC

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 check mark 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 7.01.  Regulation FD Disclosure

 

On July 10, 2023, Aytu issued a press release titled “Aytu BioPharma Announces Submission of Cotempla XR-ODT® Manufacturing Site Transfer Prior Approval Supplement.”

 

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01.  Financial Statements and Exhibits

(d) Exhibits

Exhibit No.

    

Description

99.1

Press release dated July 10, 2023

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

SIGNATURE

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.

 

Aytu BioPharma, Inc.

 

 

 

 

Date: July 10, 2023

By:

/s/ Mark K. Oki

 

 

Mark K. Oki

 

 

Chief Financial Officer

EX-99 2 aytu-20230710xex99.htm EX-99.1

Exhibit 99.1

Graphic

Aytu BioPharma Announces Submission of Cotempla XR-ODT®
Manufacturing Site Transfer Prior Approval Supplement

Company Expects a Six-Month Review of the Prior Approval Supplement Submission
by the U.S. Food & Drug Administration Which, if Approved, Enables the Transfer of
Cotempla Production to Contract Manufacturer

Upon Completion of Manufacturing Transfer of Adzenys XR-ODT and Cotempla XR-
ODT, Company Expects to Improve ADHD Product Margins by an Estimated Fifteen
Percent

ENGLEWOOD, CO / July 10, 2023 / Aytu BioPharma, Inc. (the Company or "Aytu") (NASDAQ: AYTU), a pharmaceutical company focused on developing and commercializing novel therapeutics, has submitted the Cotempla XR-ODT® (“Cotempla”) Prior Approval Supplement (PAS) to the U.S. Food & Drug Administration (FDA). If approved, the PAS would enable Aytu to transfer the production of Cotempla to the Company’s third-party manufacturer. The Company expects a six-month review of the PAS submission, which would enable FDA approval by late calendar 2023 or early calendar 2024. The Company previously announced the FDA approval of the Adzenys XR-ODT® (“Adzenys”) site transfer PAS and has begun shifting Adzenys production to the Company’s contract manufacturer.

“I’m pleased to report this additional milestone as we work to increase the profitability of our products by reducing the cost of goods sold and the expenses associated with the production of our ADHD products by leveraging the operating efficiencies of our contract manufacturer,” commented Josh Disbrow, Aytu’s Chief Executive Officer. “With this additional step now achieved, we have even greater visibility into the timing of the site transfer and expect to begin outsourced manufacturing of Adzenys and Cotempla by late 2023 or early 2024. Importantly, we have already begun shifting production of Adzenys to Aytu’s contract manufacturer. Thus, we expect to start realizing margin improvements for the ADHD brands in early calendar 2024. As we have previously communicated, upon the completion of the site transfers of both products and exiting the former Neos Therapeutics Grand Prairie, Texas facility, we expect to realize an estimated fifteen percent margin improvement of the ADHD brands. I am grateful for our team’s tremendous effort and applaud their hard work in advancing the site transfer of these important brands.”

About Aytu BioPharma, Inc.

Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products. The Company's prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu's consumer health segment markets a range of over-the-counter medicines and consumer health products addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions. To learn more, please visit aytubio.com.


Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this press release, are forward-looking statements. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with the Company's ability to realize cost savings and to transfer manufacturing of its ADHD products to a third-party contract manufacturer and the timing associated with these. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's most recent Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission.

Contacts for Investors:

Mark Oki, Chief Financial Officer

Aytu BioPharma, Inc.

moki@aytubio.com

Robert Blum or Roger Weiss

Lytham Partners

AYTU@lythampartners.com


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Document and Entity Information
Jul. 10, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Jul. 10, 2023
Entity File Number 001-38247
Entity Registrant Name AYTU BIOPHARMA, INC.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 47-0883144
Entity Address, Address Line One 373 Inverness Parkway
Entity Address, Adress Line Two Suite 206
Entity Address, City or Town Englewood
Entity Address, State or Province CO
Entity Address, Postal Zip Code 80112
City Area Code 720
Local Phone Number 437-6580
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.0001 per share
Trading Symbol AYTU
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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