Ani Pharmaceuticals reports strong Q3 2026 results

Item 2.02 Results of Operations and Financial Condition

On November 5, 2026, ANI Pharmaceuticals, Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 2026. A copy of the press release is furnished herewith as Exhibit 99.1.*¹

Item 7.01 Regulation FD Disclosure

On November 5, 2026, the Company provided a presentation in connection with a conference call and webcast¹ that will be held on November 5, 2026 with analysts and investors regarding its third quarter 2026 results and the proposed Egetis Therapeutics acquisition. A copy of the presentation will be published to the investor relations section of its website and is attached as Exhibit 99.2 hereto and incorporated herein by reference.*

Item 9.01 Exhibits

(d) Exhibits

Exhibit

No. Description

104 Cover Page Interactive Data File (embedded with the Inline XBRL document)

* The information in Item 2.02 and Item 7.01 of this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: November 5, 2026

ANI PHARMACEUTICALS, INC.

By: /s/ Stephen P. Carey

Name: Stephen P. Carey

Title: Senior Vice President Finance and Chief Financial Officer

ANI Pharmaceuticals Reports Third Quarter 2026 Financial Results

• Quarterly net revenues of $290.8 million, an increase of 27.6% year-over-year²

• Pu rified Cortrophin ® Gel net revenues of $138.7 million, an increase of 36.1% year-over-year

• Quarterly GAAP net income available to common shareholders of $35.1 million; quarterly a djusted non-GAAP EBITDA of $83.3 million, an increase of 39.8% year-over-year⁷

• Diluted GAAP income per share of $1.51 and adjusted non-GAAP diluted earnings per share of $2.70⁸

• Narrows 2026 total company revenue guidance to $1,085 - $1,125 million⁹, revises Cortrophin Gel revenue guidance to $480 - $500 million and raises both adjusted non-GAAP EBITDA to $290 - $300 million, and adjusted non-GAAP diluted earnings per share to $9.37 to $9.71

• Announced offer to acquire Egetis Therapeutics, expanding the scope and scale of ANI's Rare Disease business³

• Repurchased $20 million in common stock year-to-date

PRINCETON, N.J., November 5, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the third quarter ended September 30, 2026.

"In the third quarter, ANI delivered strong financial results, while advancing our transformation into a leading Rare Disease company," said Nikhil Lalwani, President and CEO of ANI. "Cortrophin Gel delivered solid growth, driven by momentum from the gout expansion and continued progress in our existing specialties, while our Generics business continued to outperform. We also executed on our capital allocation strategy by repurchasing shares and expanding the scope and scale of our Rare Disease business through our offer to acquire Egetis Therapeutics. This acquisition would add an FDA-approved rare disease therapy with significant long-term growth potential, that is poised to address the unmet need of patients with MCT8 deficiency who have no other approved treatment options."

"As we head into the end of the year, we are focused on delivering our 2026 financial guidance and advancing the proposed acquisition of Egetis toward closing. We are also executing multiple operational and strategic initiatives to achieve approximately 40% year-over-year growth in 2026 for Cortrophin and capture the significant multi-year growth opportunity ahead," he concluded.

Third Quarter and Recent Business Highlights:

Rare Disease

• C ortrophin Gel:

▪ Cortrophin Gel net revenues were $138.7 million for the third quarter of 2026, an increase of 36.1% over the same period in 2025.⁴ Year-over-year growth in the third quarter of 2026 was driven by momentum from the gout expansion and continued progress in the existing specialty areas of Nephrology, Neurology, Rheumatology, Ophthalmology, and Pulmonology .

▪ Leading indicators of demand in the gout expansion remained strong, with new gout patient cases doubling quarter-over-quarter and an approximately 67% increase in the number of new prescribers.

▪ However, revenue conversion was slower than expected in both existing specialties and gout, due to capacity constraints in the Company's specialty pharmacy network. The Company is expanding its specialty pharmacy network and patient support capabilities to accelerate the conversion of strong demand into patients on therapy.

• ILUVIEN:

▪ ILUVIEN ® net revenues were $22.3 million for the third quarter of 2026, an increase of 34.1% over the same perio d in 2025 due to increased volumes and phasing of international shipments.⁵

▪ The Company announced 6- and 24-month topline data from the Phase 4 open-label single-arm SYNCHRONICITY clinical trial in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) and presented select secondary endpoint analyses highlighting durable efficacy at the American Academy of Ophthalmology annual conference in October 2026.

Generics

• Generics net revenues were $104.5 million in the third quarter of 2026, an increase of 10.7% over the same period in 2025, driven by strong market demand for our existing products and new product launches in 2025 and 2026.⁶

• Launch ed 16 new Gene rics products year-to-date.

Brand Royalties and Other Revenues

• The Company recognized $11.5 million of revenue under the Harmony Agreement, comprised of $9.5 million of royalties on net sales of pitolisant-based products for the third quarter of 2026 and $2.0 million of revenue associated with the achievement of certain development milestones. In addition, the Company will continue to earn low single digit royalties on net sales of pitolisant-based products.

Brands

• Brands net revenues were $10.0 million for the third quarter of 2026, a decrease of 6.5% compared to the same period in 2025, reflecting a net decrease in demand for certain products.

Corporate Highlights

Offer to Acquire Egetis Therapeutics AB

On November 5, 2026, ANI announced a recommended p