ANI Pharmaceuticals Reports Record First Quarter 2023 Financial Results and Raises Full-Year 2023 Guidance First Quarter 2023 Financial Results -- Record quarterly net revenues of $106.8 million, re

ANI Pharmaceuticals Reports Record First Quarter

2023 Financial Results and Raises Full-Year 2023 Guidance

First Quarter 2023 Financial Results

-- Record quarterly net revenues of $106.8 million,

representing year-over-year growth of 65.6%; 2023 first-quarter net income available to common shareholders of $1.0 million and diluted

GAAP income per share of $0.06 --

-- Record quarterly adjusted non-GAAP EBITDA

of $33.0 million; 2023 first quarter adjusted non-GAAP diluted earnings per share of $1.17 --

-- Company's financial results represent

strength across all core business segments --

-- Lead Rare Disease

asset, Purified Cortrophin Gel

(Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin Gel), first quarter 2023 net sales of $16.3 million --

Full Year 2023 Guidance

-- Raises Company net revenue guidance to $385

million to $410 million from $360 million to $385 million; adjusted non-GAAP EBITDA guidance to $97 million to $107 million from $78 million

to $88 million; adjusted non-GAAP earnings per share to $2.99 to $3.45 from $2.09 to $2.59 --

-- Mid-point of revised guidance represents

year-over-year growth in net revenues of approximately 26%, adjusted non-GAAP EBITDA of approximately 83% and adjusted non-GAAP earnings

per diluted share of approximately 137% --

-- Maintains Cortrophin Gel net revenue guidance

at $80 million to $90 million (representing 92% - 116% growth versus 2022); maintains Cortrophin Gel SG&A estimate at ~10% increase

versus 2022, including modest sales force expansion --

-- Accelerating momentum of Cortrophin Gel launch;

Record number of cases initiated in the first quarter of 2023 and record number of new patient starts and cases initiated in the month

of April 2023; ACTH market continues to show year-over-year growth for ten consecutive months according to IQVIA --

-- Strengthened efforts to increase market awareness

of Cortrophin Gel through peer-to-peer education and completed modest sales force expansion into Pulmonology; Continued increase in the

number of unique and repeat prescribers --

-- Operational excellence in generics and branded

pharmaceuticals results in significant year-over-year and sequential revenue growth and capture of market opportunities --

-- FDA inspection of East Windsor, NJ facility

completed in March 2023 with zero 483s and No Action Indicated status --

-- Retained top ten ranking for new ANDA approvals

and second ranking for Competitive Generic Therapy approvals --

BAUDETTE, Minn.--(BUSINESS WIRE) - May 8, 2023 - ANI

Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three

months ended March 31, 2023.

"Our outstanding performance in the first quarter of 2023 further

demonstrates ANI's ability to compete and win across our core business segments. We are pleased to announce record quarterly net

revenues and adjusted non-GAAP EBITDA and a significant increase to full-year 2023 guidance. Importantly, we continue to invest behind

the launch of our foundational Rare Disease asset, Purified Cortrophin Gel. We continually strive to strengthen the team, improve our

approach to servicing patient, physician and payor needs, and increase access to ACTH therapy for patients in need. These efforts have

resulted in the further acceleration of our launch momentum with record quarterly new cases initiated in the first quarter of 2023, record

monthly new patient starts and cases initiated in April 2023 and first quarter net revenues of Cortrophin Gel of $16.3 million in-line

with our expectations," stated Nikhil Lalwani, President and CEO of ANI.

"Robust results in our Generics, Established Brands and Others

segment showcases ANI's ability to leverage our U.S. manufacturing footprint and our agility in operations to deliver timely solutions

to our customers. During the past two years, we have enhanced ANI's operational excellence by combining long-standing strengths

in manufacturing and our strong GMP track record with best-in-class research and development capabilities, all with a patient-first'

orientation. This has enabled us to capture market demand arising from the numerous supply disruptions impacting patient access to much-needed

medicines. We are pleased with the strong start to 2023 and look forward to continuing to serve patients in need and working hard to build

on the growth momentum throughout the year," concluded Lalwani.

First Quarter 2023 Financial Highlights:

First Quarter and Recent Business Highlights:

Rare Disease Business Update

Revenues for Cortrophin Gel totaled $16.3 million in the first quarter,

in line with internal expectations. The Company continues to see significant growth momentum as evidenced by a record number of new cases

initiated in the first quarter of 2023 and new monthly records for new patient starts and new cases in April 2023. Importantly, the

ACTH category, which had been declining since 2019, has experienced ten consecutive months of year-on-year growth from June 2022

- March 2023. In fact, the ACTH market has continued to see double-digit growth in volumes in each month of the first quarter

The Company has ramped-up promotional efforts to continue to build

awareness of Cortrophin Gel through peer-to-peer education programs across target indications of Rheumatology, Neurology and Nephrology.

In addition, the Company has executed upon its previously discussed plans to modestly expand its sales force, and its Pulmonology sales

force is now fully staffed and operational.

This strong first-quarter performance is in line with expectations,

and thus the Company is maintaining its 2023 revenue guidance for Cortrophin Gel of $80 million to $90 million, representing 92% - 116%

year-over-year growth.

Rare Disease remains a critical focus area for achieving future growth,

and the Company continues to actively explore opportunities to acquire or establish partnerships to leverage its Rare Disease platform.

Generics Business, Established Brands and Others Update

Sales of generic pharmaceuticals products grew 29.7% year-over-year

in the first quarter of 2023 and increased 10% sequentially from a strong fourth quarter in 2022. The Company's generics business

is well positioned for delivering sustainable growth driven by a strong R&D engine launching new products. Today, ANI retains a top

ten ranking for new ANDA approvals and a number two ranking for Competitive Generic Therapy Approvals. In addition, ANI received multiple

Abbreviated New Drug Applications (ANDAs) approvals, including Nitrofurantoin Oral Suspension USP, 25 mg/5 ml and Colestipol Hydrochloride

ANI's enhanced focus on operational excellence and U.S. based

manufacturing sites have enabled the Company to capture numerous opportunities arising from supply disruptions in both generics and established

brands. In addition, the Company augmented its strong GMP (Good Manufacturing Practices) track record with the successful conclusion of

a U.S Food and Drug Administration (FDA) audit at its New Jersey site with zero 483s and No Actions Indicated (NAI) status.

As previously announced, manufacturing operations ceased at the Oakville,

Ontario, site in January 2023, with the successful relocation of the Oakville products to U.S. facilities. Discussions with potential

buyers for the Oakville site are ongoing.

First Quarter 2023 Financial Results

Net revenues for generic pharmaceutical products were $63.7 million

during the three months ended March 31, 2023, an increase of 29.7% compared to $49.1 million for the same period in 2022, driven

by increased volume from the annualization of 2022 launches and a favorable product mix.

Net revenues for established brand pharmaceutical products, royalties,

and other pharmaceutical services were $26.7 million during the three months ended March 31, 2023, an increase of 90.0% compared

to $14.1 million for the same period in 2022, driven by an increase in volume.

Net revenues of rare disease pharmaceutical products, which consist

entirely of sales of Cortrophin Gel, were $16.3 million during the three months ended March 31, 2023, an increase of $15.0 million

from $1.3 million for the same period in 2022. This increase was driven by increased volume as the product was launched in late January 2022.

Operating expenses increased by 15.8% to $96.9 million for the three

months ended March 31, 2023, from $83.7 million in the prior year period as a result of the following factors:

For the three months ended March 31, 2023, cost of sales

increased to $37.7 million from $34.3 million for the same period in 2022, an increase of $3.4 million, or 10.0%. The increase is primarily

due to a shift in product mix and increased volumes of sales of generic and rare disease pharmaceutical products. During the three months

ended March 31, 2022, we recognized $3.8 million in cost of sales representing the excess of fair value over cost for inventory acquired