Full Press Release Details
ANI Pharmaceuticals Reports Third Quarter 2022
Financial Results; Reports Record Net Revenues
Third Quarter 2022 Results:
Net revenues of $83.8 million, net loss available to common shareholders of $(9.0) million and diluted GAAP loss per share of $(0.55)
Adjusted non-GAAP EBITDA of $19.6 million and adjusted non-GAAP diluted earnings per share of $0.64 --
Year-over-year net revenue growth of 61% resulting in record quarterly net revenues --
Lead Rare Disease asset, Purified Cortrophin Gel (Repository Corticotrophin Injection USP) 80 U/ml (Cortrophin) net sales
Reiterates total Company net revenue guidance of $295 million 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 --
Achieved strong Cortrophin revenue growth with 765+ cases initiated by 380 unique prescribers; continued expansion in market access and
investment in launch initiatives --
Launched several limited-competition new products; completed acquisition of four ANDAs from Oakrum Pharma LLC --
Consolidation of manufacturing network on track with expected closing of Oakville, Canada, plant by Q1 2023 --
Built out leadership team with the appointments of Meredith W. Cook as SVP, General Counsel and Corporate Secretary, and Krista L. Davis
as Chief Human Resources Officer --
BAUDETTE, Minn.--(BUSINESS WIRE) - November 9, 2022 -
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced business highlights and financial results for the three
and nine months ended September 30, 2022.
"Our third quarter results reflect clarity in our strategy and
strong focus on operational execution. We are pleased to share that ANI delivered record net revenues of $83.8 million and significant
sequential gains of non-GAAP EBITDA, which at $19.6 million is nearly double that of the second quarter of 2022. We continue to strengthen
the foundation of our Cortrophin launch with a greater than 50% increase in the number of patient cases initiated and in new and repeat
prescribers. We have also expanded market access and continue making investments in launch initiatives. Most importantly, we see evidence
that our efforts are having a favorable impact on the overall number of patients receiving critical ACTH therapy," stated Nikhil
Lalwani, President and CEO of ANI.
"Our Generics business revenues grew 51% over the prior year
on the strength of our acquisition execution and success in bringing several limited-competition drugs to market. We continue to invest
in our Generics and 505(b)(2) R&D platform to fuel future growth. These internal efforts are supplemented through business development
opportunities, such as the acquisition of four abbreviated new drug applications from Oakrum Pharma, LLC. The Oakville plant is on track
to close in the first quarter of 2023, and we have made meaningful progress with prospective buyers. Our investments in R&D, business
development and driving cost competitiveness keep us well positioned for sustainable growth in Generics," concluded Lalwani.
Third Quarter 2022 Financial Highlights:
Cortrophin Launch Update:
The Company is reiterating its 2022 revenue guidance for Cortrophin
of between $40.0 million and $45.0 million.
Key highlights (as of November 8, 2022):
Generics Growth Engine Update:
Sales of generic pharmaceuticals products grew 51% year-over-year in
the third quarter. The Company continued to focus on bringing limited-competition products to market and driving cost competitiveness.
Third Quarter 2022 Financial Results
| Three Months Ended September 30, | ||||||||||||||||
| (in thousands) | 2022 | 2021 | Change | % Change | ||||||||||||
| Generics, Established Brands, and Other Segment | ||||||||||||||||
| Generic pharmaceutical products | $ | 53,136 | $ | 35,140 | $ | 17,996 | 51.2 | % | ||||||||
| Established brand pharmaceutical products | 9,816 | 14,313 | (4,497 | ) | (31.4 | )% | ||||||||||
| Contract manufacturing | 4,779 | 2,382 | 2,397 | 100.6 | % | |||||||||||
| Royalty and other | 3,488 | 226 | 3,262 | NM | (1) | |||||||||||
| Generics, established brands, and other segment total net revenues | $ | 71,219 | $ | 52,061 | $ | 19,158 | 36.8 | % | ||||||||
| Rare Disease Segment | ||||||||||||||||
| Rare disease pharmaceutical products | $ | 12,602 | $ | - | $ | 12,602 | NM | (1) | ||||||||
| Total net revenues | $ | 83,821 | $ | 52,061 | $ | 31,760 | 61.0 | % |
Net revenues for generic pharmaceutical products were $53.1 million
during the three months ended September 30, 2022, an increase of 51% compared to $35.1 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 Pharma LLC
(Novitium), including 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 $9.8
million during the three months ended September 30, 2022, a decrease of 31% compared to $14.3 million for the same period in
2021 driven by lower volumes of many of the Company's brand products.
Contract manufacturing revenues were $4.8 million during the three months
ended September 30, 2022, an increase of 101% compared to $2.4 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.
Royalty and other revenues were $3.5 million during the three months
ended September 30, 2022, an increase of $3.3 million from $0.2 million for the same period in 2021, primarily due to a $1.2 million
licensing payment and royalty and $0.5 million of royalty revenues related to Novitium arrangements and an additional $1.5 million of
product development service revenues, partially offset by decreases in product development revenues earned by ANI Canada.
Net revenues of rare disease pharmaceutical products, which consist
entirely of sales of Cortrophin, were $12.6 million during the three months ended September 30, 2022, as the product was launched
in late January 2022. There were no sales of rare disease pharmaceutical products during the comparable prior year period.
Operating expenses increased by 60% to $88.8 million for the three
months ended September 30, 2022, from $55.6 million in the prior year period.
Cost of sales, excluding depreciation and amortization, increased by
$8.5 million to $32.9 million in the third quarter of 2022 compared to $24.4 million in the prior year period, driven primarily by $6.5
million in costs related to Novitium and $1.7 million related to an increase in the sales of products subject to profit sharing arrangements.
Research and development expenses were $7.7 million in the third quarter
of 2022, an increase of $5.2 million from the prior year period primarily due to expenses related to Novitium generic and 505(b)(2) research
and development activities and in-process research and development charges of $1.2 million recognized in the current year period.
Selling, general and administrative expenses increased to $30.1 million
in the third quarter of 2022, or 75%, compared to $17.2 million in the prior year quarter, reflecting a $10.3 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 $0.4 million decrease in transaction expenses related to the Novitium acquisition.
Depreciation and amortization increased by 25% in the third quarter
of 2022 to $14.2 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 third quarter of
2022 was $(9.0) million as compared to net loss of $(4.4) million in the prior year period. Diluted loss per share for the three months
ended September 30, 2022 was $(0.55) compared to diluted loss per share of $(0.37) in the prior year period.
Adjusted non-GAAP diluted earnings per share was $0.64 in the third
quarter of 2022 compared to $1.01 in the third 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 September 30, 2022, the Company had $56.3 million in unrestricted
cash and cash equivalents plus $140.4 million in net accounts receivable. The Company had $297.8 million (face value) in outstanding debt
as of September 30, 2022.
The Company reiterates its 2022 guidance:
- Net Revenue between $295.0 million and $315.0 million, representing
approximately 36% to 46% growth as compared to $216.1 million recognized in 2021
- Cortrophin Net Revenue between $40.0 million and $45.0 million
- Adjusted non-GAAP EBITDA between $54.0 million and $60.0 million
- Adjusted non-GAAP Diluted Earnings per Share between $1.34 and $1.62
As previously announced, ANI management will host its third quarter
2022 conference call as follows:
| Date | November 9, 2022 | |
| Time | 8:00 a.m. ET | |
| Toll free (U.S.) | 800-245-3047 | |
| Global | 203-518-9765 |
(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 800-753-6120 and entering access code 1159760.
Non-GAAP Financial Measures
Adjusted non-GAAP EBITDA
ANI's management considers adjusted non-GAAP EBITDA to be an