AYTU BIOPHARMA, INC (Form: 10-K/A, Received: 02/22/2022 16:47:16)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K/A


☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended June 30, 2021


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number 001-38247

AYTU BIOPHARMA, INC.

(Exact Name of Registrant as Specified in Its Charter)


Delaware		47-0883144
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)


373 Inverness Parkway Suite 206 Englewood, Colorado		80112
(Address of principal executive offices)		(Zip Code)

(720) 437-6580

(Registrant’s telephone number, including area code)

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

Title of Each Class

Trading Symbol

Name of each exchange on which
registered

Common Stock, par value $0.0001 per share

AYTU

The NASDAQ Capital Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ◻ No ⌧

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ◻ No ⌧

Indicate by a check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ◻

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ◻

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (check one):


Large accelerated filer	◻	Accelerated filer	☐
Non-accelerated filer	⌧	Smaller reporting company	☒
		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 13a) of the Exchange Act. ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of common stock held by non-affiliates of the Registrant as of December 31, 2020 was $88.4 million based on the closing price of $5.98 as of that date.

As of September 10, 2021, there were 27,555,120 shares of common stock issued and outstanding.

EXPLANATORY NOTE

Aytu BioPharma, Inc. ("Aytu”, “Company”, “we”, “us”, “our”), is filing this Amendment No. 1 (the “2021 Form 10-K/A”) to our Annual Report on Form 10-K for the fiscal year ended June 30, 2021 (the “2021 Form 10-K”) originally filed with the U.S. Securities and Exchange Commission (“SEC”) on September 28, 2021. This 2021 Form 10-K/A is being filed to amend and restate Item 9A Controls and Procedures.

This amendment relates (i) to the Company’s material weakness in internal control over financial reporting related to our accounting for the impairment of long-lived assets, including goodwill and other intangible assets, (ii) our conclusion that internal control over financial reporting is effective at June 30, 2021 notwithstanding the material weakness, and (iii) our exclusion of an assessment of the internal control over financial reporting related to our acquisition of Neos Therapeutics, Inc. (“Neos”) on March 19, 2021.

The following items are amended in this Amendment: (i) Part II, Item 9A. Controls and Procedures and (iii) Part IV, Item 15. Exhibits, Financial Statement Schedules. Additionally, in accordance with Rule 12b-15 under the Securities Exchange Act of 1934, as amended, the Company is including with this Amendment currently dated certifications from our principal executive officer and principal financial officer. These certifications are furnished as Exhibits.

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Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management is responsible for establishing and maintaining adequate “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures as of June 30, 2021, our principal executive officer and principal financial officer concluded that, as a result of the material weakness in our internal control over financial reporting as described below and in Part I Item 1A. of the Annual Report on Form 10-K, our disclosure controls and procedures were not effective as of the end of the period covered by this Report. Notwithstanding the material weakness, our management believes that the financial statements included elsewhere in this report present fairly, in all material respects, our financial position, results of operations, changes in stockholders’ equity (deficit) and cash flows in conformity with GAAP.

In connection with the preparation of our financial statements for the period ended June 30, 2021, we concluded that we had a material weakness in internal control over financial reporting related to our analysis for the accounting for the impairment of long-lived assets, including goodwill and other intangible assets. We perform an assessment to determine if an impairment of long-lived assets has occurred annually or when circumstances indicate an impairment may have occurred. This assessment is prepared by internal staffing and reviewed by the Chief Financial Officer. At year end, it was determined that we improperly aggregated certain assets when performing this assessment. This resulted in an incorrect conclusion that no impairment had occurred. In response, we sought and received technical guidance from third-party providers to review the assumptions and calculations included in our assessment. This deficiency did not result in a revision of any of our previously issued financial statements. However, if not addressed, the deficiency could result in a material misstatement in the future. In response, we have incorporated utilization of a third-party provider to review our assumptions and computations in our impairment analysis for completeness and accuracy. We believe that our controls are now designed properly and operating effectively.

Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in Rules 13a-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal control over financial reporting as of June 30, 2021. As permitted by SEC rules, management's assessment and conclusion on the effectiveness of the Company's internal control over financial reporting as of June 30, 2021, excludes an assessment of the internal control over financial reporting of Neos, which we acquired on March 19, 2021. Excluding the value of goodwill and intangible assets related to Neos, Neos represented 35.6% of the Company's total assets, 17.6% of our consolidated revenues and 18.0% of our gross profit, each as of June 30, 2021. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013). Our management has concluded that, as of June 30, 2021, our internal control over financial reporting was not effective based on these criteria as a result of the material weakness discussed above.

Plante Moran, PLLC, the independent registered public accounting firm that audited our financial statements included in this Annual Report on Form 10-K, was not required to issue an attestation report on our internal control over financial reporting.

Changes in Internal Control over Financial Reporting

Other than the material weakness discussed above, there were no changes in our internal controls over financial reporting, known to the Chief Executive Officer or the Chief Financial Officer that occurred during the period covered

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by this Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

The Company’s assessment over changes in our internal controls over financial reporting excluded those processes or controls that exist at our Neos subsidiary, which we acquired from the March 19, 2021 Neos Merger. Neos’ last annual report for the year ended December 31, 2020 has been audited without any qualifications. Since the merger, there has been no significant change to its internal control over financial reporting.

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PART IV

Item 15. Exhibits and Consolidated Financial Statement Schedules

(a)(3)Exhibits

Exhibit
No.

Description

Registrant’s
Form

Date Filed

Exhibit
Number

Filed
Herewith

31.1

Certificate of the Chief Executive Officer of Aytu BioScience, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

Certificate of the Chief Financial Officer of Aytu BioScience, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


		AYTU BIOPHARMA, INC.

Date: February 22, 2022	By:	/s/ Joshua R. Disbrow
		Joshua R. Disbrow
		Chairman and Chief Executive Officer
		(Principal Executive Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant in the capacities indicated, on February 22, 2022.

	Attorney-in-fact
Signature		Title

/s/ Joshua R. Disbrow		Chairman and Chief Executive Officer
Joshua R. Disbrow		(Principal Executive Officer)

/s/ Mark K. Oki		Chief Financial Officer
Mark K. Oki		(Principal Financial and Accounting Officer)

*		Director
Michael E. Macaluso

*		Director
Carl C. Dockery

*.		Director
John A. Donofrio, Jr.

*		Director
Gary V. Cantrell


*By:	/s/ Joshua R. Disbrow
	Joshua R. Disbrow
	Attorney-in-fact

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Exhibit 31.1

AYTU BIOPHARMA, INC.

Certification by Chief Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Joshua R. Disbrow, certify that:

1.	I have reviewed this report on Form 10-K/A for the year ended June 30, 2021 of Aytu BioPharma, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a—15(e) and 15d—15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a—15(f) and 15d—15(f)) for the registrant and have:

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities particularly during the period in which this report is being prepared;

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.

5.	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

All significant deficiencies or material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: February 22, 2022


	By:	/s/ Joshua R. Disbrow
		Joshua R. Disbrow
		Chief Executive Officer (Principal Executive Officer)

Exhibit 31.2

AYTU BIOPHARMA, INC.

Certification by Chief Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Mark Oki, certify that:

1.	I have reviewed this report on Form 10-K/A for the year ended June 30, 2021 of Aytu BioPharma, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

5.	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: February 22, 2022


	By:	/s/ Mark Oki
		Mark Oki
		Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)