AYTU BIOPHARMA, INC

AYTU BIOPHARMA, INC Annual Report - Plain Talk for Investors
Your coffee chat breakdown ☕

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1. What does AYTU do, and how was their year?

AYTU is a small pharmaceutical company that went "all in" on prescription drugs this year, ditching its vitamin and over-the-counter product division in July 2024. They specialize in ADHD medications (Adzenys, Cotempla) and pediatric treatments like allergy drug Karbinal. Despite this focus, they lost $13.6M in 2024 and have accumulated $333.5M in total losses since inception.

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2. Money talk: Are they growing or shrinking?

• Losses: $13.6M net loss this year – an improvement from prior years, but still in the red.
• Cost cuts: Shifted ADHD drug manufacturing to a U.S. contractor to improve profit margins.
• Big pivot: Sold their entire consumer health division to focus solely on prescriptions.

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3. Biggest wins 🏆 vs. challenges 🚧

• Wins:
  • Maintained ADHD drug supplies during industry-wide shortages.
  • Preparing to launch EXXUA, a new antidepressant, in 2025.
  • Cut unprofitable projects to focus on core products.
• Challenges:
  • Facing a lawsuit from generic drugmaker Granules over ADHD drug Adzenys (trial set for Dec 2026 – could lose 30%+ sales if they lose).
  • Only 1-2 years of cash left at current spending rates.
  • Rising material/labor costs due to inflation.

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4. Financial health check: Stable or shaky?

• Cash runway: 1-2 years remaining – the clock is ticking.
• Debt? The company didn’t provide details about debt in their annual report, but their $333.5M total losses highlight significant financial challenges.
• Bright spot: Reliable supply chain with no stockouts of key drugs for 4+ years.

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5. Risks that could hurt the stock 📉

• Adzenys lawsuit loss in 2026: Generic competition could slash sales.
• EXXUA launch failure: This new drug needs to succeed to offset losses.
• Inflation: Rising costs could undo recent cost-cutting efforts.

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6. How do they stack up against competitors?

• ADHD niche: Small but focused – their drugs have loyal prescriber bases.
• Vs. Big Pharma: No major R&D budget – relies on existing products.
• Pediatric edge: Karbinal’s reliable supply chain beats many competitors.

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7. Leadership or strategy changes?

• Survival mode: Halted all R&D spending to prioritize selling current drugs.
• M&A potential: Board appears open to mergers or acquisitions.

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8. What’s next?

• 2026 make-or-break: EXXUA’s success and the Adzenys lawsuit outcome will determine their future.
• Cash crunch: Needs a major win soon to avoid liquidity issues.

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9. Market trends & regulations to watch

• ADHD demand surge: Prescriptions up 300% since 2020 – tailwind for AYTU.
• FDA regulations: Tighter generic drug rules could help protect Adzenys.
• Inflation pressure: 67% of pharma companies report rising costs – AYTU isn’t alone.

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Bottom Line for Investors

High-risk, high-reward play: AYTU’s future hinges on two events – the 2026 Adzenys lawsuit and the EXXUA launch. If both go well, the stock could rebound sharply. If either fails, bankruptcy becomes a real risk.

Who should invest?

• Only risk-tolerant investors comfortable with potential total loss.
• Those seeking stable returns should avoid until late 2026 clarity.

Transparency note: AYTU’s annual report lacks details in key areas (debt structure, leadership changes), which could concern investors wanting full visibility.

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This isn’t financial advice – just the key facts to help you decide! ☕