ANI Pharmaceuticals Reports Record Fourth Quarter Financial Results and Achieves Full Year 2022 Revenue Milestone; Initiates 2023 Guidance Fourth Quarter and Full Year 2022 Financial Results -- Q4 n

Reports Record Fourth Quarter Financial Results and Achieves Full Year 2022 Revenue Milestone; Initiates 2023 Guidance

Fourth Quarter and Full Year 2022 Financial

-- Q4 net revenues of $94.2 million, net loss

available to common shareholders of $(4.7) million and diluted GAAP loss per share of $(0.28) -

-- Q4 Adjusted non-GAAP EBITDA of $23.3 million

and adjusted non-GAAP diluted earnings per share of $0.76 --

-- Q4 net revenue growth of

54.7% and record quarterly net revenues --

-- Full year 2022 net revenues of $316.4 million,

net loss available to common shareholders of $49.5 million, diluted GAAP loss per share of ($3.05) -

-- Full year 2022 adjusted non-GAAP EBITDA of

$55.9 million and adjusted non-GAAP diluted earnings per share of $1.36 --

-- Lead Rare Disease

asset, Purified Cortrophin Gel

(Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin) full-year 2022 net sales of $41.7 million --

Full Year 2023 Guidance

-- Initiates total Company net revenue guidance

of $360 million to $385 million; adjusted non-GAAP EBITDA guidance of $78 million to $88 million; adjusted non-GAAP earnings per share

of $2.09 to $2.59 --

-- Initiates Purified Cortrophin Gel Revenue

Guidance at $80 million to $90 million (representing 92% - 116% growth); Cortrophin SG&A increase estimated at ~10% including modest

sales force expansion

-- Continued strength of Cortrophin Gel launch,

with more than 1,120 cases initiated by more than 510 unique prescribers; ACTH market showing year-on-year growth for eight consecutive

months according to IQVIA --

-- Launched several limited-competition new

generics; retained top 10 ranking for new ANDA approvals and second ranking for Competitive Generic Therapy approvals --

-- Consolidation of manufacturing network on

track with manufacturing operations concluded at Oakville site in January 2023 --

BAUDETTE, Minn.--(BUSINESS WIRE) - March 9, 2023 -

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

and 12 months ended December 31, 2022.

"2022 was a transformative year for ANI, taking us past critical

inflection points for our two key growth drivers - the launch of Cortrophin Gel, our foundational Rare Disease asset, and investment

in our generics business. Over the course of the past year, we built a strong Rare Disease platform to support Cortrophin Gel, which also

creates the opportunity to acquire or partner on additional rare disease assets that can leverage this foundation. In addition, our continued

focus on bringing limited-competition products to market, driving cost competitiveness and providing supply reliability has helped us

absorb the generic product erosion and deliver results," stated Nikhil Lalwani, President and CEO of ANI.

"ANI's full-year 2022 revenues of $316.4 million marked

a milestone achievement for the Company and reflects the dedication and commitment of our colleagues. As we look ahead to 2023, we will

continue to focus on providing high-quality medicines to patients in need and to deliver value to all stakeholders," concluded Lalwani.

Fourth Quarter 2022 Financial Highlights:

Full Year 2022 Financial Highlights:

Fourth Quarter and Recent Business Highlights:

Rare Disease Business Update

Revenues for Cortrophin Gel totaled $17.6 million in the fourth quarter

and reached $41.7 million for the full year. Importantly, according to IQVIA, the ACTH category, which has been declining since 2019,

has experienced eight consecutive months of year-on-year growth from June 2022 - January 2023. As of March 8th,

cumulative new patient cases increased to more than 1,120 with more than 510 unique prescribers. The Company continues to see growth in

both the number of new unique and repeat prescribers.

The Company persists in its efforts with the PBMs and payers across

commercial, Medicaid and Medicare to expand market access for Cortrophin Gel for patients in need. The Company is initiating 2023 revenue

guidance for Purified Cortrophin Gel of $80 million to $90 million, representing 92% - 116% year over year growth. ANI has planned a modest

expansion of its sales force and will continue to increase awareness of Cortrophin Gel through peer-to-peer education while maintaining

direct SG&A expense within 10% of 2022 actual.

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

and the Company is actively exploring assets to acquire or partner on to leverage its Rare Disease platform.

Generics Business Update

Sales of generic pharmaceuticals products grew 39.4% year-over-year

in the fourth quarter. The continued focus on bringing limited-competition products to market and driving cost competitiveness enabled

the Company to absorb some of the generic product line erosion. Today, ANI retains a top ten ranking for new ANDA approvals and a number

two ranking for Competitive Generic Therapy Approvals. In 2022, ANI filed 12 ANDAs, and in the fourth quarter, launched multiple products,

including Trimethoprim Tablets USP, 100 mg, Fluoxetine Oral Solution, USP 20 mg/5 mL, and Levocarnitine Tablets USP, 330 mg.

The Company is also taking important steps in the area of cost excellence.

Consolidation of the Company's manufacturing network is on track. Manufacturing operations ceased at the Oakville, Ontario, site

in January 2023, and the relocation of Oakville products to U.S. facilities has been completed. The Company is in active discussions

with potential buyers for the Oakville site. Once fully executed, this operational efficiency is currently expected to improve GAAP profitability

and cash flow by $7 million to $8 million on an annualized basis.

ANI is committed to delivering high-quality medicines to customers

and patients in the United States. The U.S. Food and Drug Administration (FDA) conducted a routine Good Manufacturing Practices (cGMP)

audit at ANI's manufacturing facility in Baudette, Minnesota. ANI implemented all corrective and preventive actions and has already

received a favorable Establishment Inspection Report (EIR) classifying that its Baudette, Minnesota, facility is Voluntary Action Indicated

(VAI). This outcome further exemplifies the strong compliance history of the Baudette facility.

Fourth Quarter 2022 Financial Results

Net revenues for generic pharmaceutical products were $58.0 million

during the three months ended December 31, 2022, an increase of 39.4% compared to $41.6 million for the same period in 2021. The

net increase was primarily driven by revenues from multiple 2022 new product launches, including the launch of several limited competition

products, partially tempered by a decrease in revenues from sales of several legacy ANI generic products.

Net revenues for established brand pharmaceutical products were $12.7

million during the three months ended December 31, 2022, a decrease of 13.3% compared to $14.7 million for the same period in

2021 driven by lower volumes of many of the Company's brand products.

Contract manufacturing revenues were $4.0 million during the three months

ended December 31, 2022, an increase of 45.9% compared to $2.8 million for the same period in 2021, due to an increase in the volume

of orders, primarily related to the addition of Novitium contract manufacturing revenues.

Net revenues of rare disease pharmaceutical products, which consist

entirely of sales of Cortrophin, were $17.6 million during the three months ended December 31, 2022. The product was launched in

Operating expenses increased by 9.2% to $92.4 million for the three

months ended December 31, 2022, from $84.7 million in the prior year period as a result of the following factors:

Cost of sales, excluding depreciation and amortization, increased by

$2.4 million to $36.3 million in the fourth quarter of 2022 compared to $33.9 million in the prior year period, driven primarily by higher

Research and development expenses were $5.2 million in the fourth quarter

of 2022, an increase of $2.1 million from the prior year period, primarily due to expenses related to generic products.

Selling, general and administrative expenses increased by 8.1% to $33.2

million in the fourth quarter of 2022, compared to $30.7 million in the prior year quarter, reflecting a $3.9 million increase in sales

and marketing expenses related to our launch of Cortrophin, a full quarter's worth of Novitium headcount and activities (as compared

to a partial quarter in prior year), and increased infrastructure to support the growth in our business, partially offset by a $4.4 million

decrease in transaction expenses related to the Novitium acquisition.

Depreciation and amortization increased by 5.8% in the fourth quarter

of 2022 to $14.5 million from $13.7 million in the comparable quarter in 2021, primarily due to amortization of intangible assets acquired