ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc.

Operator: Good morning, everyone. (Operator Instructions) At this time, I'd

like to welcome everyone to ANI Pharmaceuticals Third Quarter 2022 Financial Results. (Operator Instructions) As a reminder, this conference

call is being recorded today, November 9, 2022.

It is now my pleasure to turn the floor over to Ms. Judy DiClemente, Investor

Relations for ANI Pharmaceuticals. Please go ahead.

Judy DiClemente: Thank you, Todd. Welcome to ANI Pharmaceuticals third

quarter 2022 earnings results call. This is Judy DiClemente of In-Site Communications, Investor Relations for ANI. With me on today's

call are Nikhil Lalwani, President and Chief Executive Officer; Steven Carey, Chief Financial Officer; and Christopher Mutz, Head of Rare

Disease of ANI. You can also access the webcast of this call through the Investors section of the ANI website at anipharmaceuticals.com.

Before we get started, I'd like to remind everyone that any statements

made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events

and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform

Act. These forward-looking statements are based on information available to ANI Pharmaceuticals management as of today and involve risks

and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements

are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements.

ANI specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. The archived

webcast will be available for 30 days on our website, anipharmaceuticals.com.

For the benefit of those who may be listening to the replay or archived

webcast, this call was held and recorded on November 9, 2022. Since then, ANI may have made announcements related to the topics discussed,

so please reference the company's most recent press releases and SEC filings.

And with that, I'll turn the call over to Nikhil Lalwani. Nikhil?

Thank you, Judy. Good morning, everyone, and thank you for joining

our call. Our financial results for the third quarter reflect the clarity of our Company's purpose to serve patients in need, alignment

on our growth strategy and the dedicated focus on operational execution.

I am pleased to share that ANI delivered record net revenues of $83.8

million in the third quarter of 2022, achieving 61% year-over-year growth and 13% quarter-on-quarter growth.

Our non-GAAP EBITDA this year has increased from $4.3 million in Q1

to $9.9 million in Q2 to $19.6 million in the third quarter of 2022.

Over the past 12 months we have further strengthened the foundation

of ANI with new capabilities and strategic initiatives to deliver sustainable growth:

At this time, we are maintaining our guidance of 2022 total company

revenues at $295 million to $315 million and adjusted total company non-GAAP EBITDA guidance at $54 million to $60 million.

Now, let me share details of the progress made across our key business

For our Rare Disease Business Unit, building a successful Cortrophin

Gel franchise remains our top priority. The Company achieved strong Cortrophin revenue growth, delivering $12.6 million in sales, up from

$10.2 million in the second quarter. For those new to the ANI story, ANI launched Cortrophin earlier this year in January. Cortrophin

is an NDA product that ANI acquired from Merck.

In terms of the launch trajectory, I am pleased to report that

cumulative new patient cases initiated increased by greater than 50% to 765+ cases. We also continued to make further investments in our

hub, patient support services and distribution network.

Physician interest in Cortrophin continues to build. The prescriber

base increased by greater than 50% since our last report to 380 unique prescribers and, importantly, approximately one third of the prescribers

have written more than one prescription. Prescriptions continue to be distributed across our targeted indications, which include certain

chronic auto-immune disorders, including acute exacerbations of Multiple Sclerosis and Rheumatoid Arthritis, and excess urinary protein

due to nephrotic syndrome.

We remain focused on market access and bringing savings to the healthcare

system. Our efforts are paying off, as patients across Commercial, Medicare and Medicaid payers have access to Cortrophin.

We believe that with the addition of Cortrophin into the ACTH market,

all stakeholders - namely, patients, prescribers, payers and pharmacy benefit managers - gain another treatment option. Most

importantly, we continue to see evidence that our efforts are having a favorable impact on the overall number of patients receiving critical

Turning now to the other business segments...

Our 3Q generic revenues grew by 51% over the prior year quarter on

the strength of our acquisition execution and success in bringing limited-competition drugs to market. We continue to invest in our generics

and 505 (b) (2) R&D platforms to drive future growth. During the first nine months of 2022, we filed 11 ANDAs. In the third

quarter, we also successfully launched multiple limited-competition products, including Prochlorperazine Maleate Tablets and Acebutolol

Hydrochloride Capsules.

Our previously announced plan to consolidate manufacturing operations

and cease operations at the Oakville, Ontario, Canada manufacturing facility in the first quarter of 2023 is on schedule. We have begun

manufacturing many of the Oakville products in our U.S. facilities and are starting to see the benefits of the operational efficiencies

from this initiative. As we complete this transition, we remain confident that our Baudette and New Jersey manufacturing sites can support

our future growth and provide continuous service to customers and patients in need.

As part of this process, we are actively engaged and have made meaningful

progress with a short list of potential buyers for Oakville. Once fully executed, this operational efficiency is expected to improve our

profitability and cash flow by $7 million to $8 million on an annualized basis. Steve will have more to share on this shortly, but we

currently expect one-time cash charges of approximately $2.7 million and non-cash charges of $4.4 million in conjunction with this action.

Business development is one of ANI's core strengths, and we continue

to actively supplement our internal efforts when opportunities arise. As previously announced, we completed the acquisition of four limited-competition

ANDAs from Oakrum Pharma. We expect to see the full impact of these product acquisitions in 2023.

In the established brands business unit, we continue to focus on efficiently

promoting our key brands. We utilize a suite of commercialization techniques including tele-sales teams and ongoing patients support through

copay assistance and patient starter samples. For our Dermatology portfolio, we have partnered with an established Dermatology company

and expect our key Derm brands to return to growth on the back of these efforts. We are also actively evaluating business development

deals to expand our portfolio of established brands.

Before I turn the call over to Steve, let me share an important recent

addition to the ANI leadership team. I'd like to welcome Krista L. Davis, who joined ANI as Chief Human Resources Officer. Krista

brings over 20 years of executive leadership experience in human resources, talent management, and organizational development, and will

no doubt be an asset to the company as we grow and evolve into a leading biopharmaceutical company serving patients in need.

Steve will now walk through our detailed third-quarter financial results.

Thank you, Nikhil, and good morning to everyone on the call. My comments

this morning will be focused on the three months ended September 30, 2022, versus prior year unless otherwise noted.

For the three months ended September 30, 2022, we posted total

Net Revenues of $83.8 million, up $31.8 million, or 61%, as compared to the prior year period, driven by strong gains in both of our operating

segments. Revenues for our Generics, Established Brands and Other segment were up $19.2 million, or 37%, over the prior year, while our

Rare Disease Segment posted $12.6 million during the current year quarter.

Dollarized revenue gains were driven by Generic products and the 2022

launch of Purified Cortrophin Gel.

Net revenues for generic pharmaceutical products were $53.1 million

during the third quarter of 2022, an increase of 51% compared to $35.1 million for the prior year period. The increase was principally

driven by revenues from commercial generic products acquired in our acquisition of Novitium and revenues from multiple new product launches,

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

Net revenues of rare disease pharmaceutical products, which consist

entirely of sales of Purified Cortrophin Gel, were $12.6 million during the three months ended September 30, 2022. There were no

sales of rare disease pharmaceutical products during the comparable prior year period.

Royalty and other revenues were $3.5 million in the current year quarter

an increase of $3.3 million from the prior year, principally driven by licensing and royalty income related to Novitium products.

Contract manufacturing revenues were $4.8 million during the third