Legal & controls
Item 3 and Item 9A as filed · every verdict is the registrant’s own sentence, printed below it · a filing that fails an extraction gate reads “not extracted”
| Fiscal year | Filed | Item 3 | ICFR | disclosure controls | material weakness | Filing |
|---|---|---|---|---|---|---|
| 2025-12-31 | 2026-03-26 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · To our knowledge, there are no legal proceedings pending against us, other than routine actions, administrative proceedings, and other actions not deemed material, that are expected to have a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages. On February 25, 2026, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware (‘the Court”) against Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. (“Lupin”). This lawsuit was filed following receipt of a “paragraph IV certification” notice from Lupin regarding its respective filing of an ANDA with the FDA seeking approval to engage in the commercial manufacture, use or sale of a generic version of Emrosi in t… Item 9A · ICFR · Based on the results of this assessment, management (including our Chief Executive Officer and our Chief Financial Officer) has concluded that, as of December 31, 2025, our internal control over financial reporting was effective. Item 9A · disclosure controls · Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K in providing reasonable assurance of achieving the desired control objectives. | ||||||
| 2024-12-31 | 2025-03-27 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · To our knowledge, there are no legal proceedings pending against us, other than routine actions, administrative proceedings, and other actions not deemed material, that are expected to have a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, however, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages. Item 9A · ICFR · Based on the results of this assessment, management (including our Chief Executive Officer and our Chief Financial Officer) has concluded that, as of December 31, 2024, our internal control over financial reporting was effective. Item 9A · disclosure controls · Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K in providing reasonable assurance of achieving the desired control objectives. | ||||||
| 2023-12-31 | 2024-03-29 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · To our knowledge, there are no legal proceedings pending against us, other than routine actions, administrative proceedings, and other actions not deemed material, that are expected to have a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, however, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages. Item 9A · ICFR · Based on the results of this assessment, management (including our Chief Executive Officer and our Interim Chief Financial Officer) has concluded that, as of December 31, 2023, our internal control over financial reporting was effective. Item 9A · disclosure controls · Based on that evaluation, our Chief Executive Officer and Interim Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K in providing reasonable assurance of achieving the desired control objectives. | ||||||
| 2022-12-31 | 2023-03-31 | described here | effective | effective | remediated (prior year) | EDGAR |
Item 3 · To our knowledge, there are no legal proceedings pending against us, other than routine actions, administrative proceedings, and other actions not deemed material, that are expected to have a material adverse effect on our financial condition, results of operations, or cash flows. In the ordinary course of business, however, the Company may be subject to both insured and uninsured litigation. Suits and claims may be brought against the Company by customers, suppliers, partners and/or third parties (including tort claims for personal injury arising from clinical trials of the Company’s product candidates and property damage) alleging deficiencies in performance, breach of contract, etc., and seeking resulting alleged damages. Item 9A · ICFR · Based on the results of this assessment, management (including our Chief Executive Officer and our Interim Chief Financial Officer) has concluded that, as of December 31, 2022, our internal control over financial reporting was effective. Item 9A · disclosure controls · Based on that evaluation, our Chief Executive Officer and Interim Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K in providing reasonable assurance of achieving the desired control objectives. Item 9A · material weakness · Remediation of previously reported material weakness As previously disclosed, in September 2021, an employee email account was compromised by a third-party impersonator and payments intended for a vendor, approximating $9.5 million, were fraudulently re-directed into an individual bank account controlled by this third-party impersonator. | ||||||
| 2021-12-31 | 2022-03-28 | described here | not extracted | NOT effective | disclosed | EDGAR |
Item 3 · Qbrexza Patent Litigation On March 31, 2021 we executed an Asset Purchase Agreement (the “Qbrexza APA”) with Dermira, Inc., a subsidiary of Eli Lilly and Company (“Dermira”), and the transaction closed on May 14, 2021. Pursuant to the terms of the Qbrexza APA, we acquired the rights to Qbrexza® (glycoprronium), a prescription cloth towelette to treat primary axillary hyperhidrosis in patients nine years of age or older. Upon closing of the Qbrexza purchase, we became substituted for Dermira as the plaintiff in, and are currently vigorously litigating, U.S. patent litigation commenced by Dermira on October 21, 2020 in the U.S. District Court of Delaware (the “Perrigo Patent Litigation”) against Perrigo Pharma International DAC (“Perrigo”) alleging infringement of certain patents covering Qbrexza (the “Qbrexza Patents”), which are included among the proprietary rights to Qbrexza that were acquired pursuant to the Qbrexza APA. The Perrigo Patent Litigation was initiated following the submission by Perrigo, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application (“AN… Item 9A · disclosure controls · However, given the identification of the material weakness during September 2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2021, our disclosure controls and procedures were not effective at the reasonable assurance level. Item 9A · material weakness · As a result of the foregoing, we identified a material weakness due to our internal controls having not been adequately designed to prevent or timely detect unauthorized cash disbursements. | ||||||
5 of 5 annual reports on record have their filing text cached on this host; the rest are listed with their EDGAR link and no extraction, because this surface never fetches from SEC on a page load.
- Item 3 and Item 9A are located in the filing HTML already cached on this host and read with the same line-anchored item matcher and largest-gap body disambiguation the filing-narrative pass uses for Item 1A and Item 7 — no fetch, no model, no summarization.
- A heading is accepted as a section only when it is not a table-of-contents row (a trailing page number), not a quoted reference in prose, and names its own section; the span must then clear a per-item length band and carry readable text after the heading. Anything that fails a gate is served as 'not extracted' with the reason — never as a default value.
- An effectiveness conclusion is read only from a sentence that names its own control set (disclosure controls and procedures, or internal control over financial reporting) and states an outcome. Conditional sentences — the standard limitations paragraph and forward-looking remediation language — are excluded, because they are hypotheses rather than conclusions.
- When a filing's own sentences disagree — an effective conclusion beside an unremediated material-weakness disclosure, or two conclusions of opposite sign — no verdict is asserted. A wrong 'controls were effective' reading is worse than no reading.
- Every verdict is shown beside the verbatim sentence it was read from. The excerpt is the filing's own words, capped at 1,200 characters; the filing itself is one link away.