ANI Pharmaceuticals Reports Second Quarter 2022 Financial Results; Reports Record Net Revenues and Raises Full-Year 2022 Net Revenue Guidance for Purified Cortrophin Gel Second Quarter 2022 Results: -- Net revenues of $7

ANI Pharmaceuticals Reports Second Quarter 2022

Financial Results; Reports Record Net Revenues and Raises Full-Year 2022 Net Revenue Guidance for Purified Cortrophin Gel

Second Quarter 2022 Results:

-- Net revenues of $73.9 million, net loss available

to common shareholders of $(15.3) million and diluted GAAP loss per share of $(0.94) -

-- Lead Rare Disease asset, Purified Cortrophin

Gel (Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin) net sales of $10.2 million --

-- Adjusted non-GAAP EBITDA of $9.9 million

and adjusted non-GAAP diluted earnings per share of $0.13 --

-- Year-over-year net revenue growth of 52%

Full-Year 2022 Guidance:

-- Reiterates total Company net revenue guidance of $295 to $315 million; adjusted non-GAAP EBITDA guidance of $54 million to $60 million; adjusted non-GAAP Earnings Per Share

between $1.34 and $1.62 --

-- Raises Cortrophin 2022 net revenue guidance

to $40 million to $45 million --

-- Strong launch trajectory for Cortrophin persists

with ~500 cases initiated from more than 250 unique prescribers coupled with expanded market access leading to over 134 million lives

-- Generics business ranked sixth in number

of ANDAs approved in last 12 months; launched several limited competition new products; acquired four ANDAs from Oakrum Pharmaceuticals

-- Announced consolidation of manufacturing

network with expected closing of Oakville, Canada, plant by Q1 2023 --

-- Appointed Meredith W. Cook as SVP, General

Counsel and Corporate Secretary --

BAUDETTE, Minn.--(BUSINESS WIRE) - August 8, 2022 -

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

and six months ended June 30, 2022.

"Second quarter net revenues of $73.9 million represent a

new quarterly record for the Company, driven by the first full quarter of Purified Cortrophin Gel sales and growth in generic

pharmaceuticals revenues. We continue to see acceleration in the number of patients treated with Cortrophin. We are pleased to see

over 250 prescribers, including both prescribers experienced with ACTH therapy and first-time prescribers. In addition, we have made

meaningful progress on expanding access for Cortrophin to approximately 134 million lives, including a recent positive coverage

decision by United Healthcare's commercial and managed Medicaid plans," said Nikhil

Lalwani, President and CEO of ANI.

"Our generics business unit remains focused on bringing

new products to patients and customers, and I'm proud to share that ANI is now ranked sixth among all companies in terms of

number of ANDA approvals received in the past 12 months. In addition, we continued to drive cost competitiveness by consolidating

our manufacturing network and realizing further operational efficiencies. Overall, we believe that ANI is well positioned for

sustainable growth and continuing to serve patients in need," concluded Lalwani.

Second Quarter 2022 Financial Highlights:

Cortrophin Launch Update:

The Company raises its revenue guidance for Cortrophin to be in the

range of $40 million to $45 million from its previous guidance of $35 million to $40 million.

Key highlights (as of August 5, 2022):

Generics Growth Engine Update:

Sales of generic pharmaceuticals products grew 46% year-over-year in

the second quarter. The Company remains focused on growing its new product pipeline and driving cost competitiveness.

Second Quarter 2022 Financial Results

Net revenues for generic pharmaceutical products were $49.9 million

during the three months ended June 30, 2022, an increase of 46% compared to $34.2 million for the same period in 2021. The net increase

was primarily driven by revenues from commercial generic products acquired in our acquisition of Novitium and increased revenues of Nebivolol,

which ANI launched in September 2021, partially offset by a decrease in revenues from sales of several legacy ANI generic products.

Net revenues for branded pharmaceutical products were $8.5 million

during the three months ended June 30, 2022, a decrease of 23% compared to $11.0 million for the same period in 2021. The net decrease

was principally due to a decrease in sales of InnoPran XL and Inderal XL.

Contract manufacturing revenues were $4.4 million during the three

months ended June 30, 2022, an increase of 89% compared to $2.3 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 were $10.2 million

for the quarter, consisting entirely of sales of Cortrophin Gel. There were no sales of rare disease pharmaceutical products during the

comparable prior year period.

Operating expenses increased by 35% to $86.8 million for the three

months ended June 30, 2022, from $64.2 million in the prior year period.

Cost of sales, excluding depreciation and amortization, increased by

$13.0 million to $35.3 million in the second quarter of 2022 compared to $22.3 million in the prior year period, driven primarily by $7.9

million in costs related to Novitium and $2.0 million related to an increase in the sales of products subject to profit sharing arrangements.

Research and development expenses were $4.2 million in the second quarter

of 2022, an increase of $1.4 million from the prior year period due primarily to Novitium-related activities, partially offset by a decrease

in expense associated with the completion of our Cortrophin development efforts.

Selling, general and administrative expenses increased to $32.0 million

in the second quarter of 2022, or 70%, compared to $18.8 million in the prior year quarter, reflecting a $12.5 million increase in sales

and marketing expenses related to our launch of Cortrophin and increased expenses related to the addition of Novitium headcount and activities,

partially offset by a $1.6 million decrease in transaction expenses related to the Novitium acquisition.

Depreciation and amortization increased by 22% in the second quarter

of 2022 to $13.8 million from $11.3 million in the comparable quarter in 2021, primarily due to amortization of intangible assets acquired

in the Novitium acquisition.

Net loss available to common shareholders for the second quarter of

2022 was ($15.3) million as compared to net loss of ($14.1) million in the prior year period. Diluted loss per share for the three months

ended June 30, 2022 was ($0.94) compared to diluted loss per share of ($1.17) in the prior year period.

Adjusted non-GAAP diluted earnings per share was $0.13 in the second

quarter of 2022 compared to $0.67 in the second quarter of 2021.

For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP

diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4, respectively.

As of June 30, 2022, the Company had $63.4 million in unrestricted

cash and cash equivalents plus $150.4 million in net accounts receivable. The Company had $298.5 million (face value) in outstanding debt

as of June 30, 2022.

The following summarizes 2022 guidance:

Total Company measures:

Purified Cortrophin Gel specific measures:

In addition, we currently anticipate between 16.9 and 17.0 million

shares outstanding and an effective tax rate of approximately 24% prior to any federal tax reform.

As previously announced, ANI management will host its second quarter

2022 conference call as follows:

(live and replay) www.anipharmaceuticals.com, under the "Investors" section

A replay of the conference call will be available within two hours

of the call's completion and will remain accessible for one week by dialing 800-753-6121 and entering access code 7163806.

Non-GAAP Financial Measures

Adjusted non-GAAP EBITDA

ANI's management considers adjusted non-GAAP EBITDA to be an