PBYI · CIK 0001401667
What Puma Biotechnology, Inc. told the SEC could break it.
Puma's exposure is concentrated at both ends of its NERLYNX business. On the demand side it sells through a handful of specialty pharmacies and distributors — five customers made up 27.3%, 17.0%, 16.4%, 13.1% and 10.6% of 2025 product revenue — so losing any one would hurt; on the supply side it owns no manufacturing and depends on third-party contract manufacturers (with finished goods held at CMOs in Europe) to formulate and make NERLYNX and alisertib. Layered on top are financial and policy constraints: Athyrium notes secured by substantially all of its assets that restrict dividends, and the Inflation Reduction Act's Medicare price negotiation and rebate changes, which cloud the prices and reimbursement it can obtain.
4 self-disclosed vulnerabilities, pulled from its own filings, each in the company’s words, with the source. This is the risk register almost nobody reads.
In its own words
What could break it.
Customer concentration
- five specialty-pharmacy/distributor customers each >10% of product revenuehigh
Puma sells NERLYNX through a limited number of specialty pharmacies and distributors — five customers were 27.3%, 17.0%, 16.4%, 13.1% and 10.6% of 2025 product revenue — so losing any would harm results.
“In 2025 , five customers individually comprised approximately 27.3%, 17.0%, 16.4%, 13.1% and 10.6%, respect ively, of our total product revenue.”
SEC filing →As of 2026
Liquidity & debt
- Athyrium secured notes (substantially all assets pledged; dividend restrictions)medium
Puma's Athyrium Notes are secured by substantially all of its assets and restrict dividends, with SOFR-based interest and mandatory-prepayment triggers, constraining financial flexibility.
“The Athyrium Notes are secured by substantially all of our assets.”
SEC filing →As of 2026
Regulatory & policy
- IRA Medicare drug price negotiation and pricing pressuremedium
The Inflation Reduction Act subjects certain drugs to Medicare price negotiation and other pricing/rebate changes, creating significant uncertainty over the prices and reimbursement Puma can obtain for NERLYNX.
“Most significantly, the Inflation Reduction Act (“IRA”) was enacted in 2022. This statute marks the most significant action by Congress with respect to the pharmaceutical industry since adoption of the ACA in 2010.”
Supplier concentration
- reliance on third-party CMOs to formulate/manufacture alisertib (and NERLYNX)medium
Puma owns no manufacturing and depends on third-party contractors to formulate and manufacture its products (with finished-goods inventory held at CMOs in Europe); a CMO failure to supply required volume/quality would disrupt its programs.
“We plan to rely on third party contractors to formulate and manufacture alisertib for clinical trials and these third-party contractors may be unable to formulate and manufacture alisertib in the volume and quality we require;”
SEC filing →As of 2026
The hidden graph
Who it depends on, and who depends on it.
Relationships surfaced from filings, including ones disclosed by the other side, which is how the non-obvious ones come to light.
Its suppliers
Takeda Pharmaceutical Company Limited
“Our license agreement with Takeda may be terminated by Takeda if we materially breach the agreement, in which case we would lose all rights to develop and commercialize alisertib;”
Cited →“should we commercialize any of the compounds licensed from Pfizer or any products containing any of these compounds, we will be obligated to pay to Pfizer incremental annual royalties between approximately 10% and 20% of net sales of all such products, subject, in some circumstances, to certain reductions.”
Cited →
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