ACOG — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Cost of product sales, excluding amortization of intangible assets 277,466 105,354 172,112 163

• The increase was primarily attributable to higher prescription volume resulting from increased utilization of ZUNVEYL. During the three months ended June 30, 2026, the increase in volume was 251% when compared to the three months ended June 30, 2025.

• Product revenue was also positively impacted from the increase in WAC from its $749.00 launch price per bottle to $869.36 per bottle. The increase in WAC per bottle resulted in an increase of 14% in gross product sales.

• These increases were partially offset by higher GTN deductions, including government and commercial rebates, chargebacks, and distribution-related fees. GTN deductions represented 24.4% of gross product sales during the three months ended June 30, 2026 compared with 21.1% during the comparable prior…

• Product revenue is presented net of estimated GTN deductions. GTN deductions increased from $418,902 during the three months ended June 30, 2025 to $1,931,799 during the current period.

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Comparison of the Three Months Ended March 31, 2026 and 2025

• Revenue increased by $605,144, or 21%, from $2,928,654 for the three months ended March 31, 2025 to $3,533,798 for the three months ended March 31, 2026. The increase is due to increased commercial sales of ZUNVEYL, offset by a $2,551,748 decline in licensing revenue. The Company expects that revenu…

• Comparison of Cost of Sales and Cost of Licensing Revenue for the Three Months Ended March 31, 2026 and 2025

• Cost of product sales increased by $222,312, or 838%, from $26,541 for the three months ended March 31, 2025 to $248,853 for the three months ended March 31, 2026. The increase is due to expansion of commercial sales of ZUNVEYL. The Company expects that cost of product sales will continue to increas…

• Cost of licensing revenue decreased by $787,077, or 97%, from $810,000 for the three months ended March 31, 2025 to $22,923 for the three months ended March 31, 2026. The decrease is from a reduction of royalty payments and pass-through-costs, such as consulting fees and active pharmaceutical ingred…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Our management, with the participation of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and R…

• Material Weakness in Internal Control over Financial Reporting

• As previously disclosed in our Annual Report on Form 10-K, management identified a material weakness in internal control over financial reporting as of December 31, 2025. The material weakness resulted from a lack of adequate procedures to appropriately account for accounting transactions, including…

• During the six months ended June 30, 2026, management implemented several measures designed to remediate the previously identified material weakness, including additional management review controls over account reconciliations, variance analyses, and journal entry approvals as part of the month-end …

• Although these new and enhanced controls have been designed and implemented, they have not operated for a sufficient period of time to enable management to evaluate their operating effectiveness and conclude that the previously identified material weakness has been remediated. Management will contin…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• At the end of the period covered by this quarterly report on Form 10-Q for the three months ended March 31, 2026, an evaluation was carried out under the supervision of and with the participation of our management, including the Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of…

• Management determined that disclosure controls and procedures were not effective due to the material weakness in our internal control over financial reporting, as described below, which required us to correct certain accounting items in our audited financial statements.

• Management has identified a material weakness in internal control over financial reporting in connection with the review of our condensed consolidated financial statements for the three months ended March 31, 2026. A material weakness is a deficiency, or a combination of deficiencies, in internal co…

• We plan to remediate the material weakness by enhancing our system of internal control over financial reporting, including, but not limited to, engaging external technical accounting experts to advise and review all complex accounting transactions, ensuring appropriate analysis, documentation, and o…

• During the three months ended March 31, 2026, the Company implemented enhanced month-end review procedures as part of its ongoing efforts to strengthen internal control over financial reporting. These enhancements include additional management review controls over account reconciliations, variance a…