Aytu BioPharma Reports Fiscal 2025 Second Quarter Operational and Financial Results
Aytu BioPharma Reports Fiscal 2025 Second Quarter Operational and Financial Results
Net income of $0.8 million
Adjusted EBITDA1 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 / ACCESS Newswire / 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.
- 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.
- 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.
- Cash and cash equivalents were $20.4 million at December 31, 2024, compared to $20.1 million at September 30, 2024.
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.
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)
December 31,
June 30,
2024
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
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
SOURCE: Aytu BioPharma, Inc.
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