Aytu BioPharma, Inc. (NASDAQ:AYTU) is undergoing a remarkable transformation, transitioning from a multi-pronged operation to a hyper-focused pharmaceutical company. The company's strategic initiatives, including the indefinite suspension of clinical development programs and the wind-down of its Consumer Health segment, have positioned Aytu for sustainable growth and profitability.
In the fiscal year ended June 30, 2023, Aytu reported annual net revenue of $107,399,000 and a net loss of $17,051,000. The company's annual operating cash flow and free cash flow were both -$5,129,000. However, the third quarter of fiscal 2024 showcased the company's progress, with a 21% year-over-year decline in net revenue to $17,993,000, driven by the ongoing wind-down of the Consumer Health segment. This decline was partially offset by a 49% increase in net revenue from the company's ADHD portfolio, which reached $12,326,000 in the quarter.
Business Overview
Aytu BioPharma operates through two business segments: the Rx Segment, consisting of prescription pharmaceutical products, and the Consumer Health Segment, which includes various consumer healthcare products. The company's Rx Segment is anchored by two key portfolios: the ADHD Portfolio, comprising Adzenys XR-ODT and Cotempla XR-ODT, and the Pediatric Portfolio, which includes Poly-Vi-Flor, Tri-Vi-Flor, and Karbinal ER.
The ADHD Portfolio has been a standout performer, with net revenue increasing 49% year-over-year in the third quarter of fiscal 2024. This growth has been driven by strong sales force execution and the company's innovative Aytu RxConnect platform, which provides patients with predictable and clear out-of-pocket costs for Aytu's branded ADHD products. The ongoing supply disruptions and patient access challenges in the ADHD market have further highlighted the value of Aytu's reliable product supply and patient support programs.
The Pediatric Portfolio, which accounts for approximately 12% of Rx Segment net revenue, experienced a decline of $3.5 million in the third quarter due to payer changes. However, the company has implemented various tactics to stabilize and grow the pediatric business, including reallocating resources to capitalize on recent coverage and patient access improvements.
Aytu's strategic decision to wind down its Consumer Health Segment has been a key driver of the company's transformation. This segment, which has historically generated negative cash flows, is expected to be fully closed by mid-calendar 2024, allowing Aytu to focus solely on its growing Rx business.
Financials
Aytu's third-quarter financial results demonstrate the company's progress in improving its operational and financial profile. Gross margins increased to 65% in the third quarter of fiscal 2024, up from 56% in the prior-year period, driven by the increasing ADHD revenue and the decline in lower-margin consumer product sales.
The company's operating expenses, excluding restructuring costs, changes in contingent consideration, and amortization of intangible assets, decreased by 39% year-over-year to $12.6 million in the third quarter. This reduction reflects Aytu's continued focus on cost optimization and the winding down of the Consumer Health Segment.
Aytu reported a net loss of $2,887,000, or $0.52 per share, in the third quarter of fiscal 2024, compared to a net loss of $7,200,000, or $1.93 per share, in the prior-year period. Importantly, the company's adjusted EBITDA expanded by $7 million to a positive $425,000, a significant improvement from the negative $6.5 million in the same quarter last year.
As Aytu completes the wind-down of its Consumer Health Segment, the outsourcing of ADHD brand manufacturing, and the refinancing of its $15 million term loan, the company expects to further bolster its top-line performance, lower its cost structure, and drive towards free cash flow generation and net income in the coming fiscal year.
Liquidity
Aytu ended the third quarter of fiscal 2024 with $19.8 million in cash and cash equivalents, compared to $19.5 million at the end of the previous quarter. The company's balance sheet faces challenges due to the reclassification of the $15 million term loan from long-term to short-term due to its January 2025 maturity, which has resulted in the inclusion of going concern language in the company's financial statements.
Aytu has begun the refinancing process for its term loan and believes that a new facility can be obtained on equal or better terms. The successful completion of this refinancing, coupled with the company's ongoing operational improvements, is expected to bolster Aytu's financial position and remove the need for the going concern disclosure.
Risks and Challenges
While Aytu's transformation has been impressive, the company still faces some risks and challenges. The ongoing supply chain disruptions and inflationary pressures, particularly in the Consumer Health Segment, could continue to impact the company's operations and financial performance.
Additionally, the successful wind-down of the Consumer Health Segment and the outsourcing of ADHD brand manufacturing are critical to Aytu's future success. Any delays or complications in these initiatives could adversely affect the company's financial results and cash flow generation.
Lastly, the refinancing of the $15 million term loan will be a key milestone for Aytu, as the company seeks to improve its capital structure and liquidity position. Failure to secure favorable refinancing terms could hinder the company's ability to execute its strategic plan.
Conclusion
Aytu BioPharma's transformation into a profitable specialty pharmaceutical company is well underway. The company's focus on its Rx Segment, particularly the high-growth ADHD Portfolio, coupled with the wind-down of the underperforming Consumer Health Segment, has positioned Aytu for sustainable growth and improved profitability.
The third-quarter financial results demonstrate the company's progress, with strong ADHD revenue growth, expanding gross margins, and a significant improvement in adjusted EBITDA. As Aytu completes its operational initiatives and refinances its debt, the company is poised to deliver further value to its shareholders through increased revenue, profitability, and free cash flow generation.