4.02 Two risk-factor sentences carried forward from last year were not brought up to date

Company G · a US-listed specialty pharmaceutical company · Drafting slip

DraftingLowEstablishedRegulation S-K narrative: business, risk factors and MD&A
Area of the 10-K
Item 1A Risk Factors: REMS antitrust paragraph and the UK pricing example
Year
Latest 10-K
Status
Established: Established from the company’s own documents; the requirement is clear.
Who acts
SEC Reporting, General Counsel
When
Next Form 10-K (fiscal 2026)

In brief

Two sentences in the risk factors keep last year's wording although the facts have moved on. The REMS antitrust paragraph still says [wording masked] and pre-trial proceedings' in the same breath as saying the litigation was resolved as of [date]. The UK pricing example now names the Voluntary Pricing Access and Growth scheme but keeps last year's period '2019 to 2023' and the words 'has remained unaltered', so the scheme named and the period given no longer describe the same arrangement.

The evidence, as filed

Screenshot withheld to protect the company’s identity. Even with names, figures and dates boxed out, the wording on these pages could be searched back to the filer. Pages relied on: Form 10-K 2024 (prior year), page 43; Form 10-K 2024 (prior year), page 48; Form 10-K 2025, front matter; Form 10-K 2025, page 45; Form 10-K 2025, page 50.

What the filing shows, and what the rule requires

What the filing showsWhat the rule requires

Item 1A says [wording masked] discovery while also saying it was resolved as of [date]; the UK example pairs the Voluntary Pricing Access and Growth scheme with the period 2019 to 2023.

Past tense for the 2020 transfer of the antitrust cases (or the sentence removed, as the notes now do); the UK example naming one scheme with its own period and current position.

The rule

Regulation S-K Item 105(b) (17 CFR 229.105(b))

Concisely explain how each risk affects the registrant or the securities being offered.

Version: In force from [date] · Source: Regulation S-K Item 105, 17 CFR [n], as amended by Release 33-10825

Why it applies here. both are edits that updated part of a sentence and left the rest; the Voluntary Pricing Access and Growth scheme is the arrangement that succeeded the 2019 to 2023 arrangement, so the sentence now attaches a period to a scheme it does not belong to. Neither slip changes any figure.

Why it matters

A reader of the risk factors meets a description of litigation as still to proceed and a UK example whose scheme and period do not match; neither changes a figure, but both weaken the reader's confidence that Item 1A has been refreshed for the year.

Exposure

Presentation only; no figure or required item is affected.

Our workings

Fact

the prior-year Form 10-K carried both sentences (the multidistrict sentence word for word; the UK sentence with '[wording masked]' in place of the scheme name). This year the legal-proceedings note was rewritten and no longer says the litigation 'will proceed'; it says the company resolved the entirety of the [product] Antitrust Litigation as of [date]. The risk factor added that same sentence but kept the old one beside it. In the UK sentence only the subject was changed, to the Voluntary Pricing Access and Growth scheme, while the period '2019 to 2023' and 'has remained unaltered' were kept.

Management’s best defense, and our reply

Management would say both sentences are background: the multidistrict sentence recounts what the [date] transfer provided and the very next sentence tells the reader the litigation is resolved, and the UK sentence illustrates a type of risk (a spending cap that drives the clawback rate) rather than describing a current term. They would add that the legal-proceedings note gives the full, current position, so no reader is misled. The answer: a risk factor is read as the company's current statement of each risk, and a future-tense description of litigation that has ended, or a scheme name joined to another scheme's period, is a slip that a single edit removes; it is therefore recorded as a drafting point only.

The fix

  1. Replace 'where [wording masked] and pre-trial proceedings' with 'where the multidistrict litigation proceeded'; and either restore '[wording masked] ... for 2019 to 2023' as a historical example or describe the Voluntary Pricing Access and Growth scheme with its own period and current terms.

Evidence relied on

#What it showsTypeWhere
1Current-year risk factor keeps the future tense ('will proceed') immediately before saying the litigation was resolvedDocumentForm 10-K 2025, page 45
2Prior-year risk factor: the same sentence, written while the litigation was pendingDocumentForm 10-K 2024 (prior year), page 43
3Legal-proceedings note (F-30) has been rewritten to the resolved position and no longer says the litigation will proceedDocumentForm 10-K 2025, financial-statement pages (printed F-n; see folios)
4Current-year UK example names the Voluntary Pricing Access and Growth schemeDocumentForm 10-K 2025, page 50
5The same sentence keeps the period 2019 to 2023 and 'has remained unaltered'DocumentForm 10-K 2025, page 50
6Prior-year wording: '[wording masked]' for 2019 to 2023; only the subject was changed this yearDocumentForm 10-K 2024 (prior year), page 48

Prepared by Pramanex from the company’s public SEC filings, without the company’s involvement, to show how a 10-K Pre-filing Check reads. The company is not named, and nothing on this page is a statement about any identifiable company. Observations are not an audit, review or other attestation or assurance engagement, and not legal advice. An SEC-style question is a question, not a conclusion.

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