| 1.01 | The single-segment note gives no significant segment expenses or other segment items, in both years since the new segment standard | Compliance gap | Medium | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.02 | The share-based payment note gives none of the assumptions behind the Monte Carlo value of performance awards or the purchase plan | Compliance gap | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 2.01 | Item 1C does not say whether cybersecurity risks have materially affected the company | Compliance gap | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.02 | Market risk disclosure gives no preceding-year sensitivities and does not explain why the exposures changed | Compliance gap | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 3.01 | Exhibit index: three hyperlinks to incorporated exhibits are dead or point to the wrong document, including the license filed at the SEC staff's request; two were already wrong in the prior-year 10-K | Compliance gap | Low | Cover page, exhibits, XBRL and other disclosures | Interpretation |
| 2.03 | Item 1 gives two different end dates for [product]'s orphan drug exclusivity in [indication] | Presentation | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 1.03 | [acquired business]'s acquired U.S. tax assets were fully reserved at the [date] acquisition and released in the third quarter: the evidence weighed at acquisition is not explained | Question | Medium | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.04 | Legal proceedings: no estimate of reasonably possible loss, or statement that none can be made, for matters where the company is defendant | Question | Medium | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 2.04 | The critical accounting estimates give no sensitivity for the sales-deduction accruals, the [product] and [product] intangible assets or the tax valuation allowance: is that information immaterial or not reasonably available? | Question | Medium | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 1.05 | Income tax note: the contested [country] tax assessments of about [amount] disappear from the 10-K without any word on how they ended | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.06 | Cash-flow statement: the [amount] 'proceeds from sale of an asset' is not reconciled to the [amount] [product] price given in the third-quarter Form 10-Q, and no gain or loss is stated | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.07 | Income taxes paid: an undivided 'Other' foreign line of [n], over four times the 5% jurisdiction threshold | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.08 | Cash-flow statement: no non-cash investing information, although a [amount] milestone was capitalized in 2024 and paid only in 2025 | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.09 | Income tax note: two 2023 figures in the rate reconciliation disagree with the rest of the same note, in both [n]-Ks | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.10 | Entity-wide disclosures: no revenue figure for the country of domicile ([country]), and major customers given only as percentages | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 1.11 | The goodwill roll-forward covers only the current year, although two balance sheets are presented: should the 2024 movement be shown? | Question | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 2.05 | The EU orphan market exclusivity date given for [product] does not follow the ten-year rule Item 1 describes | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.06 | The reasons given for the rise in selling, general and administrative expenses add up to more than the rise itself | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.07 | Prior-year adjustments to sales deductions are no longer called immaterial in MD&A, and neither MD&A nor the revenue note gives their amount | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 2.08 | MD&A does not quantify the reasons for the [amount] fall in clinical costs or the valuation-allowance release behind the larger tax benefit | Question | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 3.02 | Amendments to the [counterparty] authorized generic agreement, effective [date], are not filed as an exhibit | Question | Low | Cover page, exhibits, XBRL and other disclosures | Interpretation |
| 3.03 | Exhibit 10.[n]: the confidential treatment the index relies on ran only to [date] | Question | Low | Cover page, exhibits, XBRL and other disclosures | Interpretation |
| 4.01 | Two development plans given in the fiscal 2024 10-K disappear from the fiscal 2025 10-K without a word | Drafting | Low | Regulation S-K narrative: business, risk factors and MD&A | Interpretation |
| 4.02 | Two risk-factor sentences carried forward from last year were not brought up to date | Drafting | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 4.03 | Two referencing slips in the MD&A: a legal-proceedings cross-reference to the wrong note and a footnote marker pointing to the wrong footnote | Drafting | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 4.04 | Item 1 dates the [litigant] settlement to [date], names one breast cancer trial two ways, and misquotes two risk-factor headings (both years) | Drafting | Low | Regulation S-K narrative: business, risk factors and MD&A | Established |
| 4.05 | Exhibit index, Part III and amendment drafting slips in both years: duplicate exhibit number, misdated credit amendment, Exhibit 19.1 described inconsistently | Drafting | Low | Cover page, exhibits, XBRL and other disclosures | Established |
| 4.06 | Accounting-policy note: superseded impairment wording, a wrong Codification subtopic and a misstated effective date | Drafting | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |
| 4.07 | Lease note: the financing cash outflow for finance leases is the same figure as the finance-lease interest cost in every year | Drafting | Low | Financial statements, US GAAP and Regulation S-X | Interpretation |