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 of $12.6 million --
Full-Year 2022 Guidance:
-- 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 --
Company Highlights:
-- 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 --
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:
- Net revenues were $83.8 million compared to $52.1 million in Q3
2021.
- GAAP net loss available to common shareholders was $(9.0)
million, and diluted GAAP loss per share was $(0.55).
- Adjusted non-GAAP EBITDA was $19.6 million compared to $16.6
million in Q3 2021.
- Adjusted non-GAAP diluted earnings per share was $0.64,
compared to diluted earnings per share of $1.01 in Q3 2021.
- Cash and cash equivalents were $56.3 million, net accounts
receivable was $140.4 million, and face value of debt was $297.8
million as of September 30, 2022.
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):
- Launch Trajectory: Cumulative new patient cases
initiated increased by more than 50% to 765+ cases. The Company
made further investments in its hub, patient support services and
distribution network.
- Physician Interest: The prescriber base increased by
greater than 50% since the Company’s last report to 380 unique
prescribers and approximately one third of the prescribers have
written more than one prescription. Prescriptions continue to be
distributed across our targeted specialties.
- Patient Access: The Company remains focused on market
access and bringing savings to the healthcare system. Our efforts
continue to yield improved access for patients across the
country.
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.
- Focus on R&D Excellence: During the first nine
months of 2022, ANI filed 11 ANDAs and in the third quarter
successfully launched multiple limited-competition products,
including Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg; and
Acebutolol Hydrochloride Capsules. The Company continues to invest
significantly in R&D and initiated work on several new product
development projects to fuel future growth.
- Operational Synergies: The 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 track. The Company has begun manufacturing
and packaging many Oakville products in our U.S. facilities and is
beginning to recognize the operational efficiencies from this
initiative. The Company is actively engaged and has made meaningful
progress with potential buyers for Oakville. Once fully executed,
this operational efficiency is expected to improve profitability
and cash flow by $7 million to $8 million on an annualized basis.
The Company currently expects one-time cash charges of
approximately $2.7 million and non-cash charges of $4.4 million in
conjunction with this action.
- Business Development: The Company continues to be active
on the business development front, completing the acquisition of
four limited-competition ANDAs from Oakrum Pharma in July.
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
%
(1) Not meaningful.
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.
Liquidity
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.
2022 Guidance
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
Conference Call
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
Webcast (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
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
investment cycles, ages of related assets, and compensation
structures among otherwise comparable companies. Management uses
adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net (loss)/income,
excluding tax expense or benefit, interest expense, (net), other
expense, (net), depreciation, amortization, the excess of fair
value over cost of acquired inventory, non-cash stock-based
compensation expense, Novitium transaction expenses, Cortrophin
pre-launch charges, contingent consideration fair value adjustment,
and certain other items that vary in frequency and impact on ANI’s
results of operations. Adjusted non-GAAP EBITDA should be
considered in addition to, but not in lieu of, net income or loss
reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA
to the most directly comparable GAAP financial measure is provided
below.
ANI is not providing a reconciliation for the forward-looking
full year 2022 adjusted EBITDA guidance because it does not
currently have sufficient information to accurately estimate all of
the variables and individual adjustments for such reconciliation,
including “with” and “without” tax provision information. As such,
ANI’s management cannot estimate on a forward-looking basis without
unreasonable effort the impact these variables and individual
adjustments will have on its reported results.
Adjusted non-GAAP Net (Loss)/Income
ANI’s management considers adjusted non-GAAP net (loss)/income
to be an important financial indicator of ANI’s operating
performance, providing investors and analysts with a useful measure
of operating results unaffected by the excess of fair value over
cost of acquired inventory sold, non-cash stock-based compensation,
non-cash interest expense, depreciation and amortization,
Cortrophin pre-launch charges, Novitium transaction expenses,
contingent consideration fair value adjustment, and certain other
items that vary in frequency and impact on ANI’s results of
operations. Management uses adjusted non-GAAP net (loss)/income
when analyzing Company performance.
Adjusted non-GAAP net (loss)/income is defined as net
(loss)/income, plus the excess of fair value over cost of acquired
inventory sold, non-cash stock-based compensation expense, Novitium
transaction expenses, non-cash interest expense, depreciation and
amortization expense, Cortrophin pre-launch charges, contingent
consideration fair value adjustment, and certain other items that
vary in frequency and impact on ANI’s results of operations, less
the tax impact of these adjustments calculated using an estimated
statutory tax rate. Management will continually analyze this metric
and may include additional adjustments in the calculation in order
to provide further understanding of ANI’s results. Adjusted
non-GAAP net (loss)/income should be considered in addition to, but
not in lieu of, net (loss)/income reported under GAAP. A
reconciliation of adjusted non-GAAP net (loss)/income to the most
directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted (Loss)/Earnings per Share
ANI’s management considers adjusted non-GAAP diluted
(loss)/earnings per share to be an important financial indicator of
ANI’s operating performance, providing investors and analysts with
a useful measure of operating results unaffected by the excess of
fair value over cost of acquired inventory sold, non-cash
stock-based compensation, non-cash interest expense, depreciation
and amortization, Cortrophin pre-launch charges, Novitium
transaction expenses, contingent consideration fair value
adjustment, and certain other items that vary in frequency and
impact on ANI’s results of operations. Management uses adjusted
non-GAAP diluted (loss)/earnings per share when analyzing Company
performance.
Adjusted non-GAAP diluted (loss)/earnings per share is defined
as adjusted non-GAAP net (loss)/income, as defined above, divided
by the diluted weighted average shares outstanding during the
period. Management will continually analyze this metric and may
include additional adjustments in the calculation in order to
provide further understanding of ANI’s results. Adjusted non-GAAP
diluted (loss)/earnings per share should be considered in addition
to, but not in lieu of, diluted earnings or loss per share reported
under GAAP. A reconciliation of adjusted non-GAAP diluted
(loss)/earnings per share to the most directly comparable GAAP
financial measure is provided below.
About ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical
company serving patients in need by developing, manufacturing, and
marketing high quality branded and generic prescription
pharmaceutical products, including for diseases with high unmet
medical need. Our team is focused on delivering sustainable growth
by building a successful Purified Cortrophin® Gel franchise,
strengthening our generics business with enhanced development
capability, innovation in established brands and leveraging our
North American manufacturing capabilities. For more information,
please visit our website www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, those relating to the commercialization and potential sales of
the product and any additional product launches from the Company’s
generic pipeline, other statements that are not historical in
nature, particularly those that utilize terminology such as
“anticipates,” “will,” “expects,” “plans,” “potential,” “future,”
“believes,” “intends,” “continue,” other words of similar meaning,
derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the costs involved in commercializing
Cortrophin, the ability to maintain regulatory approval of the
product and maintain sufficiency of the product, the ability to
obtain reimbursement from third-party payors for this product,
evolving government legislation, the opinions and views of key
opinion leaders and physicians who treat patients with chronic
diseases and who may prescribe Cortrophin, ANI’s ability to
generate projected net product revenue and gain market share on the
timeline expected, actions taken by competitors in response to a
new market entrant; the ability of the Company to successfully
maintain manufacturing capabilities and adequate commercial
quantities of Cortrophin at acceptable costs and quality levels;
broad acceptance of Cortrophin by physicians, patients and the
healthcare community; the acceptance of pricing and placement of
Cortrophin on payers’ formularies; risks the Company may face with
respect to importing raw materials and delays in delivery of raw
materials and other ingredients and supplies necessary for the
manufacture of our products from both domestic and overseas sources
due to supply chain disruptions or for any other reason; the use of
single source suppliers and the time it may take to validate and
qualify another supplier, if necessary; manufacturing difficulties
or delays, ANI’s reliance on third parties over which it may not
always have full control, increased competition and strategies
employed by competitors; the ability to realize benefits
anticipated from acquisitions, including but not limited to, the
Oakrum product acquisition and post-close integration activities
related to the Novitium acquisition; disruptions to our operations
resulting from the ongoing shutdown and sale process relating to
our Oakville, Ontario, manufacturing plant, including the
transition of certain products manufactured there to our other
facilities, or difficulties finding a buyer for the plant; costs
and regulatory requirements relating to contract manufacturing
arrangements; delays or failure in obtaining product approvals from
the U.S. Food and Drug Administration; general business and
economic conditions, including the ongoing impact of and
uncertainties regarding the COVID-19 pandemic and inflationary
pressures; market trends for our products; regulatory environment
and changes; and regulatory and other approvals relating to product
development and manufacturing, and other risks and uncertainties
that are described in ANI’s Annual Report on Form 10-K, quarterly
reports on Form 10-Q, and other periodic reports filed with the
Securities and Exchange Commission.
More detailed information on these and additional factors that
could affect the Company’s actual results are described in the
Company’s filings with the Securities and Exchange Commission
(SEC), including its most recent annual report on Form 10-K and
quarterly reports on Form 10-Q, as well as other filings with the
SEC. All forward-looking statements in this news release speak only
as of the date of this news release and are based on the Company’s
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
ANI Pharmaceuticals, Inc. and
Subsidiaries
Table 1: US GAAP Statement of
Operations
(unaudited, in thousands, except
per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Net Revenues
$
83,821
$
52,061
$
222,153
$
155,207
Operating Expenses: Cost of sales (excl. depreciation and
amortization)
32,894
24,413
102,459
66,712
Research and development
7,657
2,456
17,096
8,229
Selling, general, and administrative
30,081
17,181
90,856
53,588
Depreciation and amortization
14,167
11,346
42,488
33,568
Contingent consideration fair value adjustment
2,476
-
2,134
-
Legal settlement expense
-
-
-
8,400
Purified Cortrophin Gel pre-launch charges
-
227
-
780
Restructuring activities
1,541
-
4,111
-
Intangible asset impairment charge
-
-
112
-
Total Operating Expenses
88,816
55,623
259,256
171,277
Operating Loss
(4,995
)
(3,562
)
(37,103
)
(16,070
)
Other Expense, net Interest expense, net
(7,264
)
(2,497
)
(20,546
)
(7,482
)
Other income/(expense), net
37
(1,071
)
712
(1,653
)
Loss Before Benefit for Income Taxes
(12,222
)
(7,130
)
(56,937
)
(25,205
)
Benefit for income taxes
3,622
2,683
13,284
6,738
Net Loss
$
(8,600
)
$
(4,447
)
$
(43,653
)
$
(18,467
)
Dividends on Series A Convertible Preferred Stock
(406
)
-
(1,218
)
-
Net Loss Available to Common Shareholders
$
(9,006
)
$
(4,447
)
$
(44,871
)
$
(18,467
)
Basic and Diluted Loss Per Share: Basic Loss Per
Share
$
(0.55
)
$
(0.37
)
$
(2.76
)
$
(1.53
)
Diluted Loss Per Share
$
(0.55
)
$
(0.37
)
$
(2.76
)
$
(1.53
)
Basic Weighted-Average Shares Outstanding
16,303
12,107
16,238
12,066
Diluted Weighted-Average Shares Outstanding
16,303
12,107
16,238
12,066
ANI Pharmaceuticals, Inc. and
Subsidiaries
Table 2: US GAAP Balance
Sheets
(unaudited, in thousands)
September 30,
2022
December 31,
2021
Current Assets Cash and cash equivalents
$
56,281
$
100,300
Accounts receivable, net
140,433
128,526
Inventories, net
95,893
81,693
Prepaid income taxes
3,778
3,667
Assets held for sale
8,020
-
Prepaid expenses and other current assets
4,972
7,589
Total Current Assets
309,377
321,775
Non-current Assets Property and equipment
72,935
75,627
Accumulated depreciation
(30,105
)
(22,956
)
Property and equipment, net
42,830
52,671
Restricted cash
5,003
5,001
Deferred tax assets, net of deferred tax liabilities and valuation
allowance
77,340
67,936
Intangible assets, net
264,237
294,122
Goodwill
28,221
27,888
Derivatives and other non-current assets
12,102
2,205
Total Assets
$
739,110
$
771,598
Current Liabilities Current debt, net of deferred financing
costs
$
850
$
850
Accounts payable
18,992
22,967
Accrued royalties
6,585
6,225
Accrued compensation and related expenses
7,745
8,522
Accrued government rebates
8,745
5,492
Returned goods reserve
33,984
35,831
Accrued expenses and other
4,726
7,650
Total Current Liabilities
81,627
87,537
Non-current Liabilities Non-current debt, net of deferred
financing costs and current component
285,882
286,520
Non-current contingent consideration
33,434
31,000
Derivatives and other non-current liabilities
1,492
7,801
Total Liabilities
$
402,435
$
412,858
Mezzanine Equity Convertible preferred stock, Series A
24,850
24,850
Stockholders' Equity Common stock
1
1
Treasury stock
(4,975
)
(3,135
)
Additional paid-in capital
399,396
387,844
Accumulated deficit
(92,636
)
(47,765
)
Accumulated other comprehensive income/(loss), net of tax
10,039
(3,055
)
Total Stockholders' Equity
311,825
333,890
Total Liabilities, Mezzanine Equity, and Stockholders'
Equity
$
739,110
$
771,598
ANI Pharmaceuticals, Inc. and
Subsidiaries
Table 3: Adjusted non-GAAP
EBITDA Calculation and US GAAP to Non-GAAP Reconciliation
(unaudited, in thousands)
Reconciliation of certain
adjusted non-GAAP accounts:
Net Revenues
Cost of sales (excl.
depreciation and
amortization)
Selling, general, and
administrative
expenses
Research and
development expenses
Three Months Ended
September 30,
Three Months Ended
September 30,
Three Months Ended
September 30,
Three Months Ended
September 30,
Three Months Ended
September 30,
2022
2021
2022
2021
2022
2021
2022
2021
2022
2021
Net Loss
$
(8,600
)
$
(4,447
)
As reported:
$
83,821
$
52,061
$
32,894
$
24,413
$
30,081
$
17,181
$
7,657
$
2,456
Add/(Subtract): Interest expense, net
7,264
2,497
Other (income)/expense, net (1)
(37
)
2,271
Benefit for income taxes
(3,622
)
(2,683
)
Depreciation and amortization
14,167
11,346
Contingent consideration fair value adjustment
2,476
-
Restructuring activities
1,541
-
Impact of Canada operations(2)
840
-
Impact of Canada
operations(2)
(969
)
-
(681
)
-
(1,052
)
-
(76
)
-
Cortrophin pre-launch charges and sales & marketing expenses(3)
-
2,192
Cortrophin pre-launch charges and
sales & marketing expenses(3)
-
-
-
-
-
(1,965
)
-
-
Stock-based compensation
3,869
2,807
Stock-based compensation
-
-
(149
)
(5
)
(3,524
)
(2,653
)
(196
)
(149
)
Excess of fair value over cost of acquired inventory
443
2,225
Excess of fair value over cost of
acquired inventory
-
-
(443
)
(2,225
)
-
-
-
-
Novitium transaction expenses
59
431
Novitium transaction expenses
-
-
-
-
(59
)
(431
)
-
-
In-process research and development charge
1,151
-
In-process research and
development charge
-
-
-
-
-
-
(1,151
)
-
Adjusted non-GAAP EBITDA
$
19,551
$
16,639
As adjusted:
$
82,852
$
52,061
$
31,621
$
22,183
$
25,446
$
12,132
$
6,234
$
2,307
(1) Adjustment to other
(income)/expense, net excludes $1.2 million of income related to
the sale of an ANDA during the three months ended September 30,
2021.
(2) Impact of Canada operations
includes revenues and operating expenses, exclusive of
restructuring activities, stock-based compensation and depreciation
and amortization, which are included within their respective line
items above.
(3) Beginning in 2022, we no
longer adjust for "Cortrophin pre-launch charges and sales and
marketing expenses" in arriving at Adjusted non-GAAP EBITDA.
Reconciliation of certain
adjusted non-GAAP accounts:
Net Revenues
Cost of sales (excl.
depreciation and
amortization)
Selling, general, and
administrative
expenses
Research and
development expenses
Nine Months Ended
September 30,
Nine Months Ended
September 30,
Nine Months Ended
September 30,
Nine Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
2022
2021
2022
2021
2022
2021
Net Loss
$
(43,653
)
$
(18,467
)
As reported:
$
222,153
$
155,207
$
102,459
$
66,712
$
90,856
$
53,588
$
17,096
$
8,229
Add/(Subtract): Interest expense, net
20,546
7,482
Other (income)/expense, net(1)
38
2,853
Benefit for income taxes
(13,284
)
(6,738
)
Depreciation and amortization
42,488
33,568
Contingent consideration fair value adjustment
2,134
-
Legal settlement expense
-
8,400
Intangible asset impairment charge
112
-
Restructuring activities
4,111
-
Impact of Canada operations(2)
2,661
-
Impact of Canada
operations(2)
(2,014
)
-
(1,930
)
-
(2,598
)
-
(147
)
-
Cortrophin pre-launch charges and sales & marketing expenses(3)
-
5,236
Cortrophin pre-launch charges and
sales & marketing expenses(3)
-
-
-
-
-
(4,456
)
-
-
Stock-based compensation
10,862
7,520
Stock-based compensation
-
-
(442
)
(15
)
(9,858
)
(7,082
)
(562
)
(423
)
Excess of fair value over cost of acquired inventory
5,246
3,717
Excess of fair value over cost of
acquired inventory
-
-
(5,246
)
(3,717
)
-
-
-
-
Novitium transaction expenses
1,276
5,064
Novitium transaction expenses
-
-
-
-
(1,276
)
(5,064
)
-
-
In-process research and development charge
1,151
-
In-process research and
development charge
-
-
-
-
-
-
(1,151
)
-
Adjusted non-GAAP EBITDA
$
33,688
$
48,635
As adjusted:
$
220,139
$
155,207
$
94,841
$
62,980
$
77,124
$
36,986
$
15,236
$
7,806
(1) Adjustment to other
(income)/expense, net excludes $750 thousand and $1.2 million of
income related to the sale of an ANDA during the nine months ended
September 30, 2022 and 2021, respectively.
(2) Impact of Canada operations
includes revenues and operating expenses, exclusive of
restructuring activities, stock-based compensation and depreciation
and amortization, which are included within their respective line
items above.
(3) Beginning in 2022, we no
longer adjust for "Cortrophin pre-launch charges and sales and
marketing expenses" in arriving at Adjusted non-GAAP EBITDA.
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 4: Adjusted non-GAAP Net
Income and Adjusted non-GAAP Diluted Earnings per Share
Reconciliation
(unaudited, in thousands, except
per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Net Loss Available to Common Shareholders
$
(9,006
)
$
(4,447
)
$
(44,871
)
$
(18,467
)
Add/(Subtract): Non-cash interest expense
963
559
2,883
1,644
Depreciation and amortization expense
14,167
11,346
42,488
33,568
Contingent consideration fair value adjustment
2,476
-
2,134
-
Restructuring activities
1,541
-
4,111
-
Legal settlement expense
-
-
-
8,400
Intangible asset impairment charge
-
-
112
-
Impact of Canada operations(1)
840
-
2,661
-
Cortrophin pre-launch charges and sales & marketing expenses(2)
-
2,192
-
5,236
Stock-based compensation
3,869
2,807
10,862
7,520
Excess of fair value over cost of acquired inventory
443
2,225
5,246
3,717
Credit facility ticking fee expense
-
2,434
-
2,434
Novitium transaction expenses
59
431
1,276
5,064
In-process research and development charge
1,151
-
1,151
-
Less: Estimated tax impact of adjustments (calc. at 24%)
(6,122
)
(5,279
)
(17,502
)
(16,220
)
Adjusted non-GAAP Net Income Available to Common
Shareholders
$
10,381
$
12,269
$
10,551
$
32,896
Diluted Weighted-Average Shares Outstanding
16,303
12,107
16,238
12,066
Adjusted Diluted Weighted-Average Shares Outstanding
16,317
12,119
16,252
12,080
Adjusted non-GAAP Diluted Earnings per Share
$
0.64
$
1.01
$
0.65
$
2.72
(1) Impact of Canada operations includes revenues and operating
expenses, exclusive of restructuring activities, stock-based
compensation and depreciation and amortization, which are included
within their respective line items above. (2) Beginning in 2022, we
no longer adjust for "Cortrophin pre-launch charges and sales and
marketing expenses" in arriving at Adjusted non-GAAP Net Loss.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221109005289/en/
Investors: Lisa M. Wilson, In-Site Communications,
Inc. 212-452-2793 lwilson@insitecony.com
Media: Faith Pomeroy-Ward, ANI Pharmaceuticals,
Inc. 817-807-8044 Faith.pomeroyward@anipharmaceuticals.com
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