8-K

AYTU BIOPHARMA, INC (AYTU)

8-K 2025-02-12 For: 2025-02-12
View Original
Added on April 10, 2026

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

February 12, 2025

Date of Report (Date of earliest event reported):

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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.)

7900 East Union Avenue, Suite 920

Denver, CO 80237

(Address of principal executive offices, including Zip Code)

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

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:

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)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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 Capital Market

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 2.02 Results of Operations and Financial Condition.

On February 12, 2025, Aytu BioPharma, Inc. (the “Company” or “Aytu”) issued a press release announcing its fiscal 2025 second quarter operational and financial results. As indicated in the press release, the Company scheduled a conference call and live audio webcast for February 12, 2025, at 4:30 p.m. Eastern time to discuss the operational and financial results and to answer questions. The conference call is publicly accessible via webcast and telephone (available live and for replay), and the press release includes instructions for accessing the webcast via the Company’s website or dialing in to the call. A replay of the call will be made available after the call on the Company’s website and via a telephone replay. Availability of the call replay posted on the Company’s website and via the telephone replay is at the Company’s discretion and may be discontinued at any time. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number Exhibit Description
99.1 Press Release dated February 12, 2025
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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.

AYTU BIOPHARMA, INC.
Date: February 12, 2025 By: /s/ Ryan J. Selhorn
Ryan J. Selhorn
Chief Financial Officer

ex_751233.htm

Exhibit 99.1

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Aytu BioPharma Reports Fiscal 2025 Second Quarter Operational and Financial Results

Net income of $0.8 million

Adjusted EBITDA^1^ of $1.3 million

Pediatric Portfolio net revenue up 86% sequentially

First quarterly sequential prescription increase for both ADHD and Pediatric portfolios since Q2 fiscal 2023

$20.4 million cash balance at December 31, 2024

Company to host conference call and webcast today, February 12, 2025, at 4:30 p.m. Eastern time

DENVER, CO / February 12 , 2025 / Aytu BioPharma, Inc. (the “Company” or “Aytu”) (Nasdaq:AYTU), a pharmaceutical company focused on commercializing novel therapeutics, today announced operational and financial results for the fiscal 2025 second quarter.

Q2 2025 Highlights

Quarterly sequential increase in prescriptions across both portfolios, led by 29% sequential growth from the Pediatric Portfolio.
Pediatric Portfolio (antihistamine franchise and pediatric multivitamin franchise) net revenue increased 86% sequentially to $2.4 million versus $1.3 million in Q1 fiscal 2025, reflecting positive effects from recently implemented return-to-growth plan for the pediatric product line. Pediatric Portfolio net revenue increased 12% compared to Q2 fiscal 2024.
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ADHD Portfolio (Adzenys XR-ODT® and Cotempla XR-ODT®) net revenue increased 16% sequentially to $13.8 million versus $11.9 million in Q1 fiscal 2025 after adjusting for a one-time vendor agreement positively impacting Q1 fiscal 2025 net revenue by $3.3 million.
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Net income in Q2 fiscal 2025 was $0.8 million, or $0.13 net income per share basic and $0.26 net loss per share diluted, compared to a net loss of $0.2 million, or $0.04 net loss per share basic and diluted in Q2 fiscal 2024.
Adjusted EBITDA was $1.3 million in Q2 fiscal 2025 compared to $5.5 million in Q2 fiscal 2024.
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Cash and cash equivalents were $20.4 million at December 31, 2024, compared to $20.1 million at September 30, 2024.
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Management Discussion

“We successfully returned both our ADHD and Pediatric portfolios to positive sequential prescription growth during the second quarter, the first such occurrence in which both portfolios exhibited sequential prescription growth since late-2022,” noted Josh Disbrow, Chief Executive Officer of Aytu. “Our entire commercial team has done a great job navigating the various dynamics of the macro landscapes for our addressable markets. In the quarter, our sales team employed a focused and efficient promotional approach to grow the ADHD Portfolio, drove broader prescribing and distribution across the Pediatric Portfolio, capitalized on improved payor coverage, and leveraged the strengths of our best-in-class Aytu RxConnect access platform.”

“This positive commercial momentum parallels our corporate optimization initiatives, driving efficiencies within our operating structure. We expect that these programs will realize at least $2.0 million in cost savings annually beyond the expense reductions we have already achieved. Our goal remains firmly focused on generating positive cash flows and increasing stockholder value. With this now our seventh consecutive quarter of positive adjusted EBITDA and second consecutive quarter of net income, I believe we are well positioned to achieve these objectives.”

“Specific to our ADHD market, the macro trends continue to show a return to more normalized supply status following the ADHD stimulant shortages over the past 18 months, which helped to temporarily bolster Adzenys and Cotempla prescriptions, resulting in boosted fiscal 2024 numbers. With more than 99,000 prescriptions written during the second fiscal quarter for our ADHD brands, we remain above the pre-stimulant shortage levels, highlighting our pronounced volume gains. Within Pediatrics, we took decisive action securing improved reimbursement and wider distribution for both our antihistamine and multi-vitamin franchises. These efforts have resulted in a significant increase in covered lives and dispensed prescriptions. We have also substantially increased our promotional footprint with our sales force as we shift promotional priorities, resulting in early traction as demonstrated by increased prescribing and pharmacy dispensing. The initial result was a 29% sequential increase in Pediatric Portfolio prescriptions.”

“We have successfully implemented a multi-year, strategic realignment to focus on our profitable prescription pharmaceutical business and leverage the unique capabilities of our now streamlined organization. These changes have resulted in the growth of our novel, commercialized prescription therapeutics, while also driving positive adjusted EBITDA and profitability. With positive operational trends in place, we remain focused on seeking opportunities to leverage our commercial infrastructure and Aytu RxConnect platform, while we pursue additional in-licensed or acquired products. We continue to expect revenue and adjusted EBITDA growth from current levels as we strive for positive cash flows. I am pleased with the significant progress made and look forward to continuing to execute on our strategy in the years to come.”

Organizational Changes and Operating Optimization Plan

Aytu has successfully repositioned itself as a growing specialty pharmaceutical company focused on commercializing novel prescription therapeutics. During the past year, the Company wound down and sold its Consumer Health business. Prior to that, the Company indefinitely suspended all clinical development programs. The Company also spent over two years working on manufacturing, operational, and regulatory initiatives to outsource the contract manufacturing of its ADHD products, culminating with the closure of the Grand Prairie, Texas manufacturing facility at the end of calendar 2024. Recently, the Company implemented an additional series of organizational changes focused on optimizing operations and driving near-term positive cash flows. As noted above, these new optimization efforts are expected to further reduce operating expenses by at least $2.0 million annually.

Consumer Health – Discontinued Operations

In June 2023, the Company announced that it had instituted a strategic mandate focusing solely on its Rx business. This mandate, now completed, encompassed Aytu’s companywide restructuring objectives. These efforts included the wind down, and subsequent divestiture in the first quarter of fiscal 2025, of the Consumer Health business, the successful outsourcing of ADHD products production and the associated closure of the Grand Prairie, Texas ADHD manufacturing facility, and the indefinite suspension of Aytu’s clinical development programs. The Company expects the savings realized from these strategic shifts to significantly enhance its operating results and drive stockholder value.

The accounting requirements for reporting the Consumer Health business divestiture as a discontinued operation were met when the wind down and divestiture was completed on July 31, 2024. Accordingly, the Company’s unaudited consolidated financial statements for all periods presented reflect the Consumer Health business as a discontinued operation. In addition, the Company’s fiscal 2024 quarterly results classify the Consumer Health business as a discontinued operation.

Net Revenue by Portfolio

Three Months Ended
December 31,
2024 2023
(in thousands)
ADHD Portfolio $ 13,816 $ 16,572
Pediatric Portfolio 2,400 2,145
Other* 5 31
Total net revenue $ 16,221 $ 18,748

*Other includes discontinued or deprioritized products.

Q2 2025 Financial Results

Net revenue for the second quarter of fiscal 2025 was $16.2 million, compared to $18.7 million for the prior year. The change was primarily due to a decrease of $2.8 million in the ADHD Portfolio, partially offset by an increase in the Pediatric Portfolio which was driven by the success of initiatives the Company has implemented to increase coverage, broaden distribution and shift and enhance promotional resources.

The ADHD Portfolio (Adzenys XR-ODT® and Cotempla XR-ODT®) experienced a 17% decrease in net revenue to $13.8 million in the second quarter of fiscal 2025, compared to the prior year period. The Pediatric Portfolio (antihistamine franchise and multivitamin franchise) experienced a 12% increase in net revenue to $2.4 million in the second quarter of fiscal 2025, compared to the prior year period. Sequentially, ADHD Portfolio net revenue increased 16% after adjusting for a one-time vendor agreement positively impacting Q1 fiscal 2025 net revenue by $3.3 million. Sequentially, Pediatric Portfolio net revenue increased 86% compared to the first quarter of fiscal 2025.

Gross profit was $10.8 million, or 66% of net revenue, in the second quarter of fiscal 2025, compared to $14.6 million, or 78% of net revenue, in the same quarter last year. The decrease in gross profit percentage is primarily related to increased cost of sales in the Company’s ADHD inventory. The inventory’s higher cost resulted from the allocation of certain overhead costs associated with the Company’s Grand Prairie, Texas manufacturing facility, to a reduced amount of ADHD product being produced there. This situation occurred as the Company ramped up production at its contract manufacturer and concurrently decreased production at Grand Prairie, Texas. This higher cost inventory is expected to be liquidated in the coming quarters as the Company continues to sell these products through its sales channels, resulting in a normalization of gross profit percentage.

Operating expenses, excluding amortization of intangible assets and restructurings costs, were $10.2 million in the second quarter of fiscal 2025 compared to $10.5 million in the prior year period. The decrease is primarily a result of continued cost reduction efforts and improved operational efficiencies.

Loss from operations was $1.7 million for the second quarter of fiscal 2025 compared to income from operations of $3.1 million in the prior year period.

Net income during the second quarter of fiscal 2025 was $0.8 million, or $0.13 net income per share basic and $0.26 net loss per share diluted, compared to a net loss of $0.2 million, or $0.04 net loss per share basic and diluted, in the prior year period. The fiscal 2025 second quarter results were impacted by $3.0 million of derivative warrant liabilities gain due primarily to the decrease in the Company’s stock price, compared to a derivative warrant liabilities loss of $0.6 million in the second quarter of fiscal 2024.

Adjusted EBITDA was $1.3 million in the second quarter of fiscal 2025, compared to $5.5 million in the prior year period.

Cash and cash equivalents were $20.4 million at December 31, 2024, compared to $20.1 million at September 30, 2024.

Conference Call Details

Date and Time: Wednesday, February 12, 2025, at 4:30 p.m. Eastern time.

Call-in Information: Interested parties can access the conference call by dialing (888) 506-0062 for United States callers or +1 (973) 528-0011 for international callers and using the participant access code 583044.

Webcast Information: The webcast will be accessible live and archived at https://www.webcaster4.com/Webcast/Page/2142/51953, and accessible on the Investors section of the Company’s website at https://investors.aytubio.com/ under Events & Presentations.

Replay: A teleconference replay of the call will be available until February 26, 2025, at (877) 481-4010 for United States callers or +1 (919) 882-2331 for international callers and using replay access code 51953.

About Aytu BioPharma, Inc.

Aytu is a pharmaceutical company focused on commercializing novel therapeutics. 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. To learn more, please visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“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 presentation, are forward-looking statements. These statements are 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 overall financial and operational performance, potential adverse changes to the Company’s financial position or our business, the results of operations, strategy and plans, changes in capital markets and the ability of the Company to finance operations in the manner expected, risks relating to gaining market acceptance of our products, our partners performing their required activities, our anticipated future cash position, regulatory and compliance challenges and future events under current and potential future collaborations. We also refer you to (i) the risks described in “Risk Factors” in Part I, Item 1A of our most recent Annual Report on Form 10‑K and in the other reports and documents we file with the United States Securities and Exchange Commission.​

Footnote 1

Aytu uses the term adjusted EBITDA, which is a term not defined under United States generally accepted accounting principles (“U.S. GAAP”). The Company uses this term because it is a widely accepted financial indicator utilized to analyze and compare companies on the basis of operating performance. The Company believes that presenting adjusted EBITDA by certain categories allows investors to evaluate the various performance of these categories. The Company’s method of computation of adjusted EBITDA may or may not be comparable to other similarly titled measures used by other companies. We believe that net income (loss) is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to adjusted EBITDA. See below for a reconciliation of net income (loss) to adjusted EBITDA.

Contacts for Investors

Ryan Selhorn, Chief Financial Officer

Aytu BioPharma, Inc.

rselhorn@aytubio.com

Robert Blum or Roger Weiss

Lytham Partners

aytu@lythampartners.com


Aytu BioPharma, Inc.

Unaudited Consolidated Statements of Operations

(in thousands, except share and per share data)

Three Months Ended
December 31,
2024 2023
Net revenue $ 16,221 $ 18,748
Cost of sales 5,435 4,145
Gross profit 10,786 14,603
Operating expenses:
Selling and marketing 5,272 5,218
General and administrative 4,449 4,800
Research and development 522 521
Amortization of intangible assets 921 918
Restructuring costs 1,317
Total operating expenses 12,481 11,457
(Loss) income from operations (1,695 ) 3,146 ****
Other income, net 140 96
Interest expense (1,079 ) (1,266 )
Derivative warrant liabilities gain (loss) 3,016 (577 )
Income from continuing operations before income tax expense 382 1,399 ****
Income tax benefit (expense) 283 (780 )
Net income from continuing operations 665 619 ****
Net income (loss) from discontinued operations, net of tax 123 (839 )
Net income (loss) $ 788 $ (220 )
Basic weighted-average common shares outstanding 6,132,060 5,517,670
Diluted weighted-average common shares outstanding 8,485,112 5,517,670
Net income (loss) per share:
Basic - continuing operations $ 0.11 $ 0.11
Diluted - continuing operations $ (0.28 ) $ 0.11
Basic - discontinued operations, net of tax $ 0.02 $ (0.15 )
Diluted - discontinued operations, net of tax $ 0.01 $ (0.15 )
Basic - net income (loss) $ 0.13 $ (0.04 )
Diluted - net loss $ (0.26 ) $ (0.04 )

Aytu BioPharma, Inc.

Unaudited Consolidated Balance Sheets

(in thousands, except share data)

June 30,
2024
ASSETS **** ****
Current assets:
Cash and cash equivalents 20,398 $ 20,006
Accounts receivable, net 25,403 23,526
Inventories 11,085 12,141
Prepaid expenses and other current assets 6,167 5,097
Current assets of discontinued operations 1,121
Total current assets 63,053 61,891
Non-current assets:
Property and equipment, net 516 693
Operating lease right-of-use assets 1,178 829
Intangible assets, net 49,958 52,453
Other non-current assets 1,522 2,185
Non-current assets of discontinued operations 44
Total non-current assets 53,174 56,204
Total assets 116,227 $ 118,095
LIABILITIES AND STOCKHOLDERS’ EQUITY **** ****
Current liabilities:
Accounts payable 11,699 $ 10,314
Accrued liabilities 39,372 38,143
Revolving credit facility 4,012 2,395
Current portion of debt 1,857 1,857
Other current liabilities 7,108 8,962
Current liabilities of discontinued operations 557
Total current liabilities 64,048 62,228
Non-current liabilities:
Debt, net of current portion 9,983 10,877
Derivative warrant liabilities 6,386 12,745
Other non-current liabilities 5,045 4,529
Total non-current liabilities 21,414 28,151
Stockholders’ equity:
Preferred stock, par value .0001; 50,000,000 shares authorized; no shares issued or outstanding
Common stock, par value .0001; 200,000,000 shares authorized; 6,169,681 and 5,972,638 shares issued and outstanding, respectively 1 1
Additional paid-in capital 348,475 347,688
Accumulated deficit (317,711 ) (319,973 )
Total stockholders’ equity 30,765 27,716
Total liabilities and stockholders’ equity 116,227 $ 118,095

All values are in US Dollars.


Aytu BioPharma, Inc.

Unaudited Reconciliation of Net Income (Loss) to Adjusted EBITDA

(in thousands)

Three Months Ended
December 31,
2024 2023
Net income (loss) - GAAP $ 788 $ (220 )
Interest expense 1,079 1,266
Income tax (benefit) expense (283 ) 780
Depreciation and amortization 1,292 1,510
Stock-based compensation expense 151 707
Other income, net (140 ) (96 )
Derivative warrant liabilities (gain) loss (3,016 ) 577
Restructuring costs 1,317
Pipeline research and development costs 208 96
Net (income) loss from discontinued operations, net of tax (123 ) 839
Adjusted EBITDA - non-GAAP $ 1,273 $ 5,459

Aytu BioPharma, Inc.

Unaudited Fiscal 2024 Quarterly and Full Year Consolidated Statements of Operations Adjusted for Discontinued Operations

(in thousands)

Three Months Ended Twelve Months Ended
June 30, 2024 March 31, 2024 December 31, 2023 September 30, 2023 June 30, 2024
(as adjusted)
Net revenue $ 14,593 $ 14,025 $ 18,748 $ 17,817 $ 65,183
Cost of sales 3,541 3,664 4,145 4,779 16,129
Gross profit 11,052 10,361 14,603 13,038 49,054
Operating expenses:
Selling and marketing 5,422 5,352 5,218 6,091 22,083
General and administrative 4,028 4,831 4,800 6,295 19,954
Research and development 1,042 611 521 595 2,769
Amortization of intangible assets 921 920 918 924 3,683
Restructuring costs 1,912 244 2,156
Total operating expenses 13,325 11,958 11,457 13,905 50,645
(Loss) income from operations (2,273 ) (1,597 ) 3,146 (867 ) (1,591 )
Other income, net 120 70 96 584 870
Interest expense (1,253 ) (1,257 ) (1,266 ) (1,283 ) (5,059 )
Derivative warrant liabilities gain (loss) 1,463 1,017 (577 ) (5,907 ) (4,004 )
Loss on debt extinguishment (594 ) (594 )
(Loss) income from continuing operations before income tax expense (2,537 ) (1,767 ) 1,399 (7,473 ) (10,378 )
Income tax expense (695 ) (245 ) (780 ) (1,720 )
Net (loss) income from continuing operations (3,232 ) (2,012 ) 619 (7,473 ) (12,098 )
Net loss from discontinued operations, net of tax (1,385 ) (875 ) (839 ) (647 ) (3,746 )
Net loss $ (4,617 ) $ (2,887 ) $ (220 ) $ (8,120 ) $ (15,844 )

Aytu BioPharma, Inc.

Unaudited Fiscal 2024 Reconciliation of Net Loss Adjusted for Discontinued Operations to Adjusted EBITDA

(in thousands)

Three Months Ended Twelve Months Ended
June 30, 2024 March 31, 2024 December 31, 2023 September 30, 2023 June 30, 2024
(as adjusted)
Net loss - GAAP $ (4,617 ) $ (2,887 ) $ (220 ) $ (8,120 ) $ (15,844 )
Interest expense 1,253 1,257 1,266 1,283 5,059
Income tax expense 695 245 780 1,720
Depreciation and amortization 1,398 1,449 1,510 1,553 5,910
Stock-based compensation expense 243 699 707 725 2,374
Other income, net (120 ) (70 ) (96 ) (584 ) (870 )
Derivative warrant liabilities (gain) loss (1,463 ) (1,017 ) 577 5,907 4,004
One-time transactions 150 851 1,001
Restructuring costs 1,912 244 2,156
Loss on extinguishment of debt 594 594
Pipeline research and development costs 599 136 96 152 983
Net loss from discontinued operations, net of tax 1,385 875 839 647 3,746
Adjusted EBITDA - non-GAAP $ 2,029 $ 931 $ 5,459 $ 2,414 $ 10,833