ANI Pharmaceuticals Reports Full Year and Fourth Quarter 2019 Results, Provides 2020 Guidance and Remains on Track to Submit Cortrophin Gel sNDA to FDA in March 2020 For the full year ended

ANI Pharmaceuticals Reports Full Year and Fourth Quarter

2019 Results, Provides 2020 Guidance and Remains on Track to Submit Cortrophin Gel sNDA to FDA in March 2020

For the full year ended December 31, 2019:

For the fourth quarter 2019:

Baudette, Minnesota (February 27, 2020) - ANI Pharmaceuticals,

Inc. ("ANI") (NASDAQ: ANIP) today reported its financial results for the three and twelve months ended December

31, 2019 and provided its 2020 financial guidance. The Company will host its earnings conference call this morning, February 27,

2020, at 10:30 AM ET. Investors and other interested parties can join the call by dialing (866) 776-8875. The conference ID is

(a) See ANI's Form 10-K filed February 27,

2020 for discussion of year-to-date results.

(b) See Table 3 for US GAAP reconciliation.

(c) See Table 4 for US GAAP reconciliation.

Arthur S. Przybyl, President and CEO, stated,

"ANI generated record net revenues and non-GAAP

gross profit in 2019 while continuing to diversify its commercial product offering and pipeline opportunities. While revenues

and non-GAAP gross profit for three of our important generic products were negatively impacted in recent periods, overall our business

remains resilient, and we look forward to leveraging important recent launches such as Vancomycin Oral Solution and Bretylium Tosylate

Injection as well as the recently acquired Amerigen portfolio in 2020. During 2019, we launched several new products, entered

into collaborative arrangements with strategic partners and acquired both previously approved and development stage products we

plan to launch in the future. We have utilized strong operating cash flows for asset acquisitions and investment into our portfolio

of pipeline products and expect to continue to do so in the future.

During the fourth quarter, we successfully completed

our fourth commercial scale batch of both Corticotropin API and the Cortrophin Gel drug product, and importantly, remain

on track to submit our supplemental NDA filing in March 2020."

2020 Financial Guidance

For the twelve months ending December 31, 2020, ANI is

providing guidance on net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share. The following

table summarizes 2020 guidance as compared to 2019 actual results:

In addition, we expect that adjusted non-GAAP gross margin,

defined as the result of Net Revenues less Cost of Sales (excluding depreciation and amortization) as a percentage of Net Revenues,

will decline from approximately 71% in 2019 to the mid 60% range in 2020, driven by the impact of negative price and product mix.

Year over year changes of our Adjusted non-GAAP diluted earnings per share metric differ from our Adjusted non-GAAP EBITDA metric

due to a projected increase in cash interest expense resulting from the refinancing of our convertible debt to bank debt.

ANI's full year 2020 financial guidance reflects management's

current assumptions regarding customer relationships, product pricing, prescription trends, competition, inventory levels, cost

of sales, operating costs, timing of research and development spend, taxes, and the anticipated timing of future product launches

and other key events.

Cortrophin Gel Re-commercialization Update

(d) Based on data from IQVIA

We continue to successfully progress our Cortrophin

Gel re-commercialization program. Significant accomplishments since the third quarter 2019 press release (dated November 6, 2019)

ANI is on track to file the sNDA as planned by March 2020.

For further details, please see ANI's Cortrophin

Gel Re-commercialization Milestone Update in Table 5.

Fourth Quarter Results

Generic Pharmaceutical Products

Fourth Quarter Net Revenues - Results and Update

Net revenues from sales of generic pharmaceuticals decreased

14% to $29.1 million from $33.7 million in the prior period, primarily due to decreases in sales of Esterified Estrogen with Methlytestosterone

("EEMT"), Erythromycin Ethylsuccinate ("EES"), Propafenone,

and Fenofibrate. These decreases were tempered by the September 2019 launch of Vancomycin HCl for Oral Solution as well as increased

unit sales of Vancomycin tablets.

Branded Pharmaceutical Products

Fourth Quarter Net Revenues - Results and Update

Net revenues from sales of branded pharmaceuticals decreased

17% to $15.6 million from $18.8 million in the prior period, primarily due to decrease in sales of Inderal LA, Atacand

and Atacand HCT . These decreases were tempered by increased sales of InnoPran XL .

Contract Manufacturing

Fourth Quarter Net Revenues - Results and Update

Contract manufacturing revenues decreased 28% to $2.6 million

from $3.7 million in the prior year period, due to the timing and volume of orders from contract manufacturing customers in the

Fourth Quarter Net Revenues - Result and Update

Royalty and Other decreased 34% to $0.6 million from $0.9 million,

primarily due to the timing and volume of product development and laboratory services revenue earned by ANI Canada.

Operating expenses increased to $52.6 million for the three

months ended December 31, 2019, from $45.7 million in the prior year period. The increase was primarily due to the following:

These increases were partially offset by a $2.3 million decrease

in cost of sales as a result of the previously mentioned royalty buyout in January 2019 and a decrease in sales over the comparable

periods, tempered by Q4 2019 inventory reserve charges of $4.6 million primarily related to the Company's exit from the Methylphenidate

Extended Release market.

Cost of sales as a percentage of net revenues increased to 37%

during the three months ended December 31, 2019, from 35% during same period in 2018. The increase was primarily due to the inventory

reserve charges recognized in the fourth quarter 2019 and negative price, which were tempered by reductions related to the 2019

Net Loss and Diluted Loss per Share

Net loss was $4.8 million for the three months ended December

31, 2019, as compared to net income of $5.4 million in the prior year period. The net loss was driven by the previously mentioned

$6.5 million build of Cortrophin pre-launch commercial inventories and $4.6 million of inventory reserve charges. The effective

consolidated tax benefit rate for the three months ended December 31, 2019 was 37%.

Diluted loss per share for the three months ended December 31,

2019 was $0.41, based on 11,886 thousand diluted shares outstanding, as compared to diluted earnings per share of $0.46 in the

prior year period. Adjusted non-GAAP diluted earnings per share was $1.08, as compared to adjusted non-GAAP diluted earnings per

share of $1.32 in the prior year period. For a reconciliation of adjusted non-GAAP diluted earnings per share to the most directly

comparable GAAP financial measure, please see Table 4.

ANI Product Development Pipeline

ANI's pipeline consists of 118 products, addressing a

total annual market size of $7.0 billion, based on data from IQVIA. Of these, ANI expects that at least 52 can be commercialized

based on either CBE-30s or prior approval supplements filed with the FDA.

Non-GAAP Financial Measures

The Company's fiscal 2019 guidance for adjusted non-GAAP EBITDA

and adjusted non-GAAP diluted earnings per share is not reconciled to the most comparable GAAP measure. This is due to the inherent

difficulty of forecasting the timing or amount of items that would be included in a reconciliation to the most directly comparable

forward-looking GAAP financial measures. Because a reconciliation is not available without unreasonable effort, it is not included

Adjusted non-GAAP EBITDA

ANI's management considers adjusted non-GAAP EBITDA to

be an important financial indicator of ANI's operating performance, providing investors and analysts with a useful measure

of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital