Earnings summaries and quarterly performance for ANI PHARMACEUTICALS.
Executive leadership at ANI PHARMACEUTICALS.
Nikhil Lalwani
Detailed
President and Chief Executive Officer
CEO
CG
Chad Gassert
Detailed
Senior Vice President, Corporate Development & Strategy
CM
Christopher Mutz
Detailed
Senior Vice President, Head of Rare Disease
KD
Krista Davis
Detailed
Senior Vice President and Chief Human Resources Officer
MC
Meredith Cook
Detailed
Senior Vice President, General Counsel and Corporate Secretary
MS
Muthusamy Shanmugam
Detailed
Head of Research & Development and Chief Operating Officer of NJ Operations
OG
Ori Gutwerg
Detailed
Senior Vice President, Generics
SC
Stephen Carey
Detailed
Senior Vice President, Finance and Chief Financial Officer
TR
Thomas Rowland
Detailed
Senior Vice President, Head of Established Brands
Board of directors at ANI PHARMACEUTICALS.
Research analysts who have asked questions during ANI PHARMACEUTICALS earnings calls.
David Amsellem
Piper Sandler Companies
4 questions for ANIP
Also covers: ABBV, ALKS, AMGN +27 more
Gary Nachman
Raymond James
4 questions for ANIP
Also covers: ABBV, ACHV, ADMA +9 more
Faisal Khurshid
Leerink Partners
3 questions for ANIP
Also covers: ABCL, GERN, GLPG +4 more
LS
Leszek Sulewski
Truist Securities
3 questions for ANIP
Also covers: AKBA, AMRX, BHC +6 more
Vamil Divan
Guggenheim Securities
3 questions for ANIP
Also covers: ABBV, ABSI, BHVN +7 more
EK
Ekaterina Knyazkova
Cantor Fitzgerald
2 questions for ANIP
Also covers: AMPH, ELAN, PAHC
BF
Brandon Folkes
Rodman & Renshaw
1 question for ANIP
Also covers: ACHV, AVDL, CRMD +10 more
DK
Daniel Krizay
Guggenheim Partners, LLC
1 question for ANIP
GS
Glen Santangelo
Jefferies
1 question for ANIP
Also covers: ALGN, BHC, CAH +12 more
Jeevan Larson
Truist Securities
1 question for ANIP
OL
Oren Livnat
H.C. Wainwright
1 question for ANIP
Also covers: AVDL, CARA, COLL +7 more
Recent press releases and 8-K filings for ANIP.
ANI Pharmaceuticals Provides 2026 Guidance and Highlights Rare Disease Transformation
ANIP
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- ANI Pharmaceuticals provided 2026 guidance projecting net revenues of $1,055-$1,115 million (24%-28% growth) and adjusted non-GAAP EBITDA of $275-$290 million (24%-27% growth). This follows 2025 net revenues of $854-$873 million and adjusted non-GAAP EBITDA of $221-$228 million, which grew over 39% and 42% respectively.
- The company is accelerating its transformation into a leading rare disease company, with the rare disease business expected to contribute approximately 60% of total revenues in 2026. Purified Cortrophin Gel, the lead asset, is projected to achieve $540-$575 million in net revenues in 2026, representing 55%-65% growth, driven by existing indications and a significant investment in expanding into acute gouty arthritis flares.
- The generics business, which generated strong cash flows and grew in the low 20s in 2025, is anticipated to be largely flattish in 2026 but will continue to support the rare disease expansion through cash generation.
- ANI Pharmaceuticals ended 2025 with approximately $285 million in cash on the balance sheet and less than 1.7 times net leverage, with plans to accrue cash for future rare disease M&A.
Jan 13, 2026, 11:00 PM
ANI Pharmaceuticals Outlines 2026 Growth Strategy and Financial Guidance
ANIP
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- ANI Pharmaceuticals projects 2026 net revenues of $1,055-$1,115 million, representing 24%-28% growth, and adjusted non-GAAP EBITDA of $275-$290 million, a 24%-27% increase.
- The company is accelerating its transformation into a leading rare disease company, with this segment expected to account for approximately 60% of total revenues in 2026. The lead asset, Purified Cortrophin Gel, is projected to grow 55%-65% to $540-$575 million in net revenues.
- A significant investment of $50 million is planned for 2026 to deploy a 90-person organization by mid-year, focused on expanding Purified Cortrophin Gel's reach into acute gouty arthritis flares.
- The generics business, a strong cash flow generator, is anticipated to be "largely flattish" in 2026 compared to 2025 following robust growth in 2025.
- ANI ended 2025 with approximately $285 million in cash and less than 1.7 times net leverage, with capital allocation prioritizing rare disease business expansion through acquisitions of commercial assets.
Jan 13, 2026, 11:00 PM
ANI Pharmaceuticals Provides 2026 Guidance and Strategic Priorities
ANIP
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- ANI Pharmaceuticals projects strong growth for 2026, with net revenue guidance of $1,055-$1,115 million (24%-28% growth) and adjusted non-GAAP EBITDA guidance of $275-$290 million (24%-27% growth). This follows a robust 2025, where net revenues grew by over 39% to $854-$873 million and adjusted non-GAAP EBITDA grew over 42% to $221-$228 million.
- The company is accelerating its transformation into a leading rare disease company, with the segment expected to comprise approximately 60% of total revenues in 2026. Purified Cortrophin Gel, the lead asset, is projected to grow 55%-65% to $540-$575 million in 2026, supported by a new 90-person organization for acute gouty arthritis flares.
- The generics business, a strong cash flow generator, aims for 10-15 new product launches annually, though 2026 generics revenue is expected to be largely flattish compared to 2025 after significant growth.
- ANI ended 2025 with $285 million in cash and less than 1.7 times net leverage, with capital allocation prioritizing expansion of the rare disease business, likely through acquisitions of commercial assets without clinical risk.
Jan 13, 2026, 11:00 PM
ANI Pharmaceuticals Provides Preliminary 2025 Results and 2026 Financial Guidance
ANIP
Guidance Update
Earnings
New Projects/Investments
- ANI Pharmaceuticals announced preliminary unaudited full year 2025 results, with total net revenues expected within or above the guidance range of $854 million to $873 million, and adjusted non-GAAP EBITDA within or above $221 million to $228 million.
- The company provided full year 2026 financial guidance, forecasting total net revenues between $1,055 million and $1,115 million and adjusted non-GAAP EBITDA of $275 million to $290 million.
- The Rare Disease business is a primary growth driver, with Cortrophin Gel net revenues reaching $347.8 million in 2025 (up 76% year-over-year) and expected to be $540 million to $575 million in 2026. This segment is projected to account for approximately 60% of total net revenues in 2026.
- ANI plans to expand its Rare Disease organization by approximately 90 people by mid-2026 to target the opportunity for Cortrophin Gel in acute gouty arthritis flares.
Jan 12, 2026, 9:15 PM
ANI Pharmaceuticals Provides Strong 2026 Financial Guidance and Highlights Rare Disease Focus
ANIP
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- ANI Pharmaceuticals projects total net revenues to exceed $1 billion in 2026, with guidance ranging from $1,055 million to $1,115 million, representing a 24-28% year-over-year growth.
- The company is transforming into a leading Rare Disease company, with this segment expected to represent approximately 60% of total revenues in 2026.
- Cortrophin Gel, a lead Rare Disease asset, is projected to achieve $540 million to $575 million in net revenue in 2026, indicating a 55-65% year-over-year growth.
- Adjusted Non-GAAP EBITDA is guided to be between $275 million and $290 million for 2026, reflecting a 24-27% year-over-year increase.
- The Generics business continues to deliver strong cash flows, supported by superior R&D capabilities and a U.S. manufacturing footprint, with plans for 10-15 new product launches annually.
Jan 12, 2026, 12:00 PM
ANI Pharmaceuticals Discusses 2025 Guidance and Strategic Priorities
ANIP
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- ANI Pharmaceuticals provided 2025 revenue guidance of $854 million-$873 million, representing 39%-42% growth (34%-37% organic), and adjusted non-GAAP EBITDA guidance of $221 million-$228 million, a 42%-46% increase over the prior year.
- The company's top strategic priority is to expand its rare disease business with Purified Cortrophin Gel and ILUVIEN, reinvesting EBITDA and cash flows from its generics and brands segments.
- For M&A, ANI is focused on acquiring commercial assets that meaningfully add to its rare disease business, avoiding clinical risk, and is willing to temporarily increase net leverage above three with a clear deleveraging plan.
- The market for Cortrophin Gel is projected to reach approximately $993 million in 2025, with significant growth driven by new prescribers (approximately half of prescribers were naive to ACTH before using Cortrophin Gel) and the recent launch of a prefilled syringe, which accounts for over 70% of new cases initiated.
- 2025 is considered a "reset year" for ILUVIEN, with efforts focused on strengthening the commercial organization, sharing NEW DAY study results, and addressing Medicare copay support issues by promoting the Part D pathway.
Dec 2, 2025, 7:00 PM
ANI Pharmaceuticals CEO Discusses 2025 Outlook and Strategic Priorities
ANIP
Guidance Update
New Projects/Investments
M&A
- ANI Pharmaceuticals is a growing, profitable biopharmaceutical company with three segments: rare disease (Cortrophin Gel, ILUVIEN), generics, and brands, which fund reinvestment into the rare disease business.
- The company provided 2025 guidance for revenues of $854 million-$873 million (39%-42% growth) and adjusted non-GAAP EBITDA of $221 million-$228 million (42%-46% growth), reporting $263 million cash as of September 30th and 1.7x net leverage.
- A primary strategic focus is expanding the rare disease business, particularly Cortrophin Gel, which is part of an estimated $993 million market in 2025 and has seen half of its prescribers new to ACTH.
- ANI is actively seeking M&A opportunities for commercial rare disease assets that would meaningfully add to its approximately $425 million rare disease business, while avoiding clinical risk and maintaining a disciplined approach to leverage.
Dec 2, 2025, 7:00 PM
ANI Pharmaceuticals Provides 2025 Guidance and Strategic Updates at Piper Sandler Conference
ANIP
Guidance Update
New Projects/Investments
Product Launch
- ANI Pharmaceuticals provided 2025 revenue guidance of $854 million to $873 million, representing 39%-42% growth, and adjusted non-GAAP EBITDA guidance of $221 million to $228 million, a 42%-46% increase over the prior year.
- The company's primary strategic priority is to expand its rare disease business, which is projected to account for approximately half of estimated 2025 revenues, by reinvesting cash flows generated from its generics and brands segments.
- The market for Cortrophin Gel is expected to reach approximately $993 million in 2025, with significant growth potential, as roughly half of its prescribers were new to ACTH before writing their first prescription. The prefilled syringe presentation has seen strong adoption, with more than 70% of new cases initiated using it.
- The generics business is driven by a robust R&D capability, leading to a cadence of 10 to 15 new product launches annually, supported by strong operational execution and U.S.-based manufacturing facilities.
Dec 2, 2025, 7:00 PM
ANI Pharmaceuticals Provides Strong 2025 Guidance and Details Growth Drivers
ANIP
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- ANI Pharmaceuticals provided 2025 guidance for total company revenues of $854 million-$873 million, reflecting 39%-42% year-over-year growth (organic growth 34%-37%), adjusted non-GAAP EBITDA of $221 million-$228 million (42%-46% year-over-year growth), and adjusted non-GAAP EPS of $7.37-$7.64 (42%-46% year-over-year growth).
- The company's lead rare disease asset, Purified Cortrophin Gel, is guided for $347 million-$354 million in 2025, representing 75%-78% growth, driven by underlying patient demand, Salesforce expansion, and investments in clinical evidence generation and patient convenience.
- Iluvien's 2025 guidance is $73 million-$77 million, which is considered a "reset year" due to factors like reduced funding for Medicare copay support and sales force integration; however, it is expected to grow in 2026 based on the addressable patient population, an experienced commercial organization, and new clinical study results.
- The Medicare Part D redesign in 2025 provided a moderate tailwind due to improved patient access, though this was moderated by rebates, and no significant changes are expected from this in 2026.
Nov 18, 2025, 3:00 PM
ANI Pharmaceuticals Provides 2025 Guidance and Discusses Product Growth
ANIP
Guidance Update
Revenue Acceleration/Inflection
New Projects/Investments
- ANI Pharmaceuticals projects 2025 total company revenues of $854 million-$873 million, reflecting 39%-42% year-over-year growth, with adjusted non-GAAP EBITDA expected to be $221 million-$228 million and adjusted non-GAAP EPS between $7.37-$7.64, both showing 42%-46% year-over-year growth.
- The company's lead rare disease asset, Purified Cortrophin Gel, is guided to generate $347 million-$354 million in 2025, an increase of 75%-78% year-over-year, driven by strong patient demand, Salesforce expansion, and ongoing clinical evidence generation.
- ILUVIEN is expected to achieve $73 million-$77 million in revenue for 2025, which is viewed as a "reset year" with anticipated growth from this baseline in 2026, despite challenges like reduced copay support funding.
- The Medicare Part D redesign in 2025 resulted in a moderate tailwind due to improved patient access, with similar effects expected in 2026 as changes in rebates are minimal.
Nov 18, 2025, 3:00 PM
Quarterly earnings call transcripts for ANI PHARMACEUTICALS.
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