PBYI

Business Context and Reporting Period

This Form 8-K Current Report from Puma Biotechnology, Inc. (PBYI) is dated May 17, 2024. The filing addresses a significant development in the ongoing patent infringement litigation against AstraZeneca regarding the drug Tagrisso (osimertinib). Puma is an exclusive licensee of the patents in question under an agreement with Pfizer (parent of Wyeth LLC).

Key Financial Metrics and Litigation Outcome

The filing does not provide standard financial metrics such as revenue, profit, cash flow, margins, debt, or liquidity for a specific reporting period. The primary financial data point disclosed is the result of a jury verdict:

• Verdict Date: May 17, 2024
• Plaintiffs: Wyeth LLC (Puma remains a beneficiary via license agreement)
• Defendant: AstraZeneca
• Jury Finding: Infringement of U.S. Patent Nos. 10,603,314 and 10,596,162; patents found not invalid.
• Monetary Award: $107.5 million in damages for past acts of infringement.

Material Changes and Procedural Status

While Puma was dismissed as a plaintiff in the litigation on March 18, 2024, due to a lack of constitutional standing, the company retains contractual rights to recover monetary damages under its exclusive license agreement with Pfizer. The April 29, 2024 dismissal of AstraZeneca's counterclaims against Puma further solidified the company's position to benefit from the verdict. The $107.5 million award represents a material potential asset, though the final distribution depends on the contractual terms with Pfizer.

Outlook, Risks, and Unusual Items

Future Proceedings:

• Future Damages: Further proceedings are scheduled to determine the appropriate royalty rate for the remainder of the patent terms.
• Equitable Defenses: A bench trial is scheduled for June 17-18 and 20, 2024, to address AstraZeneca's remaining equitable defenses, including unclean hands, patent misuse, and indefiniteness.

Risks: The final financial impact remains contingent on the outcome of the bench trial regarding equitable defenses and the determination of future royalty rates. The filing does not provide management commentary on the company's broader operational outlook beyond this litigation.

Investor Verification Checklist

• Verify the specific terms of the Puma-Pfizer license agreement to confirm the exact percentage or amount of the $107.5 million award Puma is entitled to receive.
• Monitor the June 2024 bench trial schedule for rulings on AstraZeneca's equitable defenses, which could potentially reduce or negate the damages.
• Track the court's determination of the future royalty rate, which will impact long-term revenue projections.
• Review subsequent filings for any updates on the collection of the awarded damages.