ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today
announced financial results and business highlights for the fourth
quarter and full year ended December 31, 2023.
Nikhil Lalwani, President and CEO of ANI stated,
“The fourth quarter capped off a record year for ANI, as we
delivered record growth in annual net revenue and adjusted non-GAAP
EBITDA. For our lead Rare Disease asset, Cortrophin Gel, new
patient starts accelerated in Q4, and we posted the strongest
sequential growth in net revenue to date. The momentum continued
for new cases initiated, new unique and repeat prescribers, and we
made steady gains across all core indications while also tapping
into new therapeutic areas.”
“In 2024, we will continue to use our highly
capable R&D engine, operational excellence and U.S.-based
manufacturing footprint to launch new products and address patient
needs. We expect our Rare Disease business to remain the primary
driver of growth, with our Cortrophin Gel franchise estimated to
deliver more than a 50% year-on-year increase in revenues in 2024.
We are still early in the trajectory for this franchise and believe
we have plenty of headroom to drive market share in our core
therapeutic areas while also addressing new indications and
expanding the overall ACTH market. We believe our strong balance
sheet gives us the flexibility to further increase the scope and
scale of our Rare Disease business by adding an asset that will
leverage our well-established platform. With a record 2023, we are
excited about the path ahead, and the opportunity to continue
‘Serving Patients, Improving Lives’,” concluded Mr. Lalwani.
Fourth Quarter and Recent Business
Highlights:
Rare Disease Business
Revenues for the Company’s lead asset, Cortrophin
Gel, totaled $41.7 million for the fourth quarter of 2023, an
increase of 137.3% over the same period in 2022, driven by
increased volume. During the quarter, the Company achieved a record
number of new cases initiated and new patient starts, and saw
continued growth in the number of new unique and repeat
prescribers. The overall ACTH category again experienced growth led
by increased demand for Cortrophin Gel across the initially
targeted specialties of neurology, rheumatology, and nephrology,
while gaining momentum in the newer area of pulmonology.
The Company continues to believe that its Rare
Disease business remains ANI’s largest future growth driver, and is
actively exploring opportunities to acquire assets and/or establish
partnerships to increase its scope and scale.
Generics Business, Established Brands and Other
Revenues for generic pharmaceuticals products,
established brands and other grew 17.3% year-over-year in the
fourth quarter of 2023. ANI’s Generics business concluded a
successful year with 11 new products launched, 20 new products
filed and the number two ranking retained in Competitive Generic
Therapy approvals.
Throughout 2023, ANI supplied patients with over
1.5 billion doses of therapeutics to patients in need and leveraged
its operational excellence and U.S.-based manufacturing to further
market share gains by providing customers a stable supply of
products.
Fourth Quarter 2023 Financial
Results
|
Three Months Ended December 31, |
|
|
(in thousands) |
|
2023 |
|
|
|
2022 |
|
|
Change |
% Change |
Generics, Established Brands, and Other
Segment |
|
|
|
|
Generic pharmaceutical products |
$ |
71,826 |
|
|
$ |
58,014 |
|
|
$ |
13,812 |
|
|
23.8 |
% |
Established brand pharmaceutical products, royalties, and other
pharmaceutical services |
|
18,079 |
|
|
|
18,628 |
|
|
|
(549 |
) |
|
(2.9 |
)% |
Generics, established brands, and other segment total net
revenues |
$ |
89,905 |
|
|
$ |
76,642 |
|
|
$ |
13,263 |
|
|
17.3 |
% |
Rare Disease Segment |
|
|
|
|
Rare disease pharmaceutical products |
|
41,749 |
|
|
|
17,590 |
|
|
|
24,159 |
|
|
137.3 |
% |
Total net revenues |
$ |
131,654 |
|
|
$ |
94,232 |
|
|
$ |
37,422 |
|
|
39.7 |
% |
|
|
|
|
|
Net revenues for generic pharmaceutical products
were $71.8 million, an increase of 23.8% year-over-year, driven by
increased volumes in the base business and contribution from new
products launched in 2022 and 2023.
Net revenues for established brand pharmaceutical
products, royalties, and other pharmaceutical services were $18.1
million, a decrease of 2.9% year-over-year, driven by lower
volume.
Net revenues for Rare Disease pharmaceutical
products, which consist entirely of sales of Cortrophin Gel, were
$41.7 million, an increase of 137.3% year-over-year driven by
increased volume.
Operating expenses were $124.9 million, an increase
of 35.2% year-over-year, as a result of the following factors:
- Cost of sales increased 47.1%
year-over-year to $53.4 million, primarily due to significant
growth in sales volumes of generic and Rare Disease pharmaceutical
products.
- Research and development expenses
increased 89.0% year-over-year to $9.9 million, primarily due to a
higher level of activity associated with ongoing and new
projects.
- Selling, general, and administrative
expenses increased 34.0% year-over-year to $44.5 million, primarily
due to increased employment related costs, Rare Disease sales and
marketing costs, legal expenses, and patient assistance program
costs, as well as an overall increase in activities required to
support growth.
Net income available to common shareholders for the
fourth quarter of 2023 was $0.7 million as compared to net loss of
$(4.7) million in the prior year period. Diluted earnings per share
for the fourth quarter of 2023 was $0.04 compared to diluted GAAP
loss per share of $(0.28) in the prior year period.
Adjusted non-GAAP diluted earnings per share was
$1.00 in the fourth quarter of 2023 compared to $0.76 in the fourth
quarter of 2022.
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
below, respectively.
Liquidity
As of December 31, 2023, the Company had $221.1
million in unrestricted cash and cash equivalents, $162.1 million
in net accounts receivable and $294.0 million (face value) in
outstanding debt. The Company generated year-to-date cash flow from
operations of $119.0 million.
Full Year 2024 Guidance:
(in millions, except for
percentages and EPS) |
2024 Guidance |
2023 Actual |
Growth |
Net Revenue (Total Company) |
$520 million - $542 million |
$ |
486.8 |
7% - 11% |
Cortrophin Gel Net Revenue |
$170 million - $180 million |
$ |
112.1 |
52% - 61% |
Adjusted Non-GAAP EBITDA |
$135 million - $145 million |
$ |
133.8 |
1% - 8% |
Adjusted Non-GAAP Diluted EPS |
$4.26 - $4.67 |
$ |
4.71 |
(10)% - (8)% |
|
|
|
|
ANI expects total company adjusted non-GAAP gross
margin between 62% and 63%. In addition, the Company anticipates
between 19.3 million and 19.7 million shares outstanding
(reflective of a full year of shares outstanding resulting from the
May 2023 equity raise) for the purpose of calculating diluted EPS
and a U.S. GAAP effective tax rate of between approximately 20.0%
to 22.0%. The Company will tax effect non-GAAP adjustments for
computation of adjusted non-GAAP diluted earnings per share at a
tax rate of 26.0%.
Conference Call
The Company’s management will host a conference
call today to discuss its fourth quarter and full-year 2023
results.
Date TimeToll free (U.S.) |
Thursday, February 29, 20248:30 a.m. ET800-274-8461 |
|
|
This conference call will also be webcast and can
be accessed from the “Investors” section of ANI’s website at
www.anipharmaceuticals.com. The webcast replay of the call will be
available at the same site approximately one hour after the end of
the call.
A replay of the conference call will also be
available within two hours of the call’s completion and will remain
accessible for two weeks by dialing 800-839-8531 and entering
access code 4470257.
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.
Beginning in the fourth quarter of 2022, ANI no longer excludes
expense for In-Process Research & Development or Cortrophin Gel
pre-launch charges and sales and marketing expenses from its
non-GAAP results. Historically, the Company excluded these charges.
These changes have been made to align with views expressed by the
U.S. Securities and Exchange Commission. Prior periods have been
recast to reflect these changes.
Adjusted non-GAAP EBITDA is defined as net income
(loss), 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, 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 2024 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 Income
(Loss)
ANI’s management considers adjusted non-GAAP net
income (loss) 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, 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 income (loss) when analyzing
Company performance. Beginning in the fourth quarter of 2022, ANI
no longer excludes expense for In-Process Research &
Development or Cortrophin Gel pre-launch charges and sales and
marketing expenses from its non-GAAP results. Historically, the
Company excluded these charges. These changes have been made to
align with views expressed by the U.S. Securities and Exchange
Commission. Prior periods have been recast to reflect these
changes.
Adjusted non-GAAP net income (loss) is defined as
net income (loss), 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, 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 income (loss) should be considered in addition to, but not in
lieu of, net income (loss) reported under GAAP. A reconciliation of
adjusted non-GAAP net income (loss) to the most directly comparable
GAAP financial measure is provided below.
Adjusted non-GAAP Diluted
Earnings (Loss) per Share
ANI’s management considers adjusted non-GAAP
diluted earnings (loss) 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, 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 earnings
(loss) per share when analyzing Company performance.
Adjusted non-GAAP diluted earnings (loss) per share
is defined as adjusted non-GAAP net income (loss), 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 earnings (loss) 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
earnings (loss) per share to the most directly comparable GAAP
financial measure is provided below.
ANI is not providing a reconciliation for the
forward-looking full year 2024 adjusted diluted earnings per share
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.
About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) 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 scaling up our Rare Disease
business through the successful launch of our lead asset, Purified
Cortrophin® Gel, strengthening our generics business with enhanced
research and development capability, innovation in established
brands and leveraging our U.S.-based 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: Cortrophin Gel is our first
rare disease pharmaceutical product; to the extent we are not able
to continue to achieve commercial success with this product,
including expanding the market and gaining market share, our
business, financial condition, and results of operations will be
negatively impacted; our approved products, including Cortrophin
Gel, may not achieve commercialization at levels of market
acceptance that will continue to allow us to achieve profitability;
acquisitions and other investments could disrupt our business and
harm our financial position and operating results; the limited
number of suppliers for our active pharmaceutical ingredients could
result in lengthy delays in production if we need to change
suppliers; delays or failure in obtaining or maintaining approvals
by the FDA of the products we sell; changes in policy or actions
that may be taken by the FDA and other regulatory agencies,
including drug recalls; acceptance of our products at levels that
will allow us to achieve profitability; risks that we 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
ability of our manufacturing partners to meet our product demands
and timelines; our dependence on single source suppliers of
ingredients due to the time and cost to validate a second source of
supply; our ability to develop, license or acquire, and
commercialize new products; the level of competition we face and
the legal, regulatory and/or legislative strategies employed by our
competitors to prevent or delay competition from generic
alternatives to branded products; our ability to protect our
intellectual property rights; the impact of legislative or
regulatory reform on the pricing for pharmaceutical products; the
impact of any litigation to which we are, or may become, a party;
our ability, and that of our suppliers, development partners, and
manufacturing partners, to comply with laws, regulations and
standards that govern or affect the pharmaceutical and
biotechnology industries; our ability to maintain the services of
our key executives and other personnel; whether we experience
difficulties closing a sale transaction with a buyer for the plant
and property resulting from the closure of our Oakville, Ontario
manufacturing plant; and general business and economic conditions,
such as inflationary pressures, geopolitical conditions including
but not limited to the conflict between Russia and the Ukraine, the
conflict between Israel and Gaza, or conflicts relating to attacks
on cargo ships in the Red Sea, and the effects and duration of
outbreaks of public health emergencies, such as COVID-19, 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.
Investor Contact Lisa M.
Wilson, In-Site Communications, Inc. 212-452-2793
lwilson@insitecony.com
SOURCE: ANI Pharmaceuticals, Inc.
|
ANI Pharmaceuticals, Inc. and
SubsidiariesTable 1: US GAAP Statement of
Operations(unaudited, in thousands, except per share
amounts) |
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net Revenues |
$ |
131,654 |
|
|
$ |
94,232 |
|
|
$ |
486,816 |
|
|
$ |
316,385 |
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Cost of sales (excluding depreciation and amortization) |
|
53,420 |
|
|
|
36,326 |
|
|
|
181,513 |
|
|
|
138,785 |
|
Research and development |
|
9,867 |
|
|
|
5,222 |
|
|
|
34,286 |
|
|
|
22,318 |
|
Selling, general, and administrative |
|
44,462 |
|
|
|
33,188 |
|
|
|
161,697 |
|
|
|
124,044 |
|
Depreciation and amortization |
|
15,194 |
|
|
|
14,484 |
|
|
|
59,791 |
|
|
|
56,972 |
|
Contingent consideration fair value adjustment |
|
1,985 |
|
|
|
1,624 |
|
|
|
1,426 |
|
|
|
3,758 |
|
Restructuring activities |
|
- |
|
|
|
1,568 |
|
|
|
1,132 |
|
|
|
5,679 |
|
Intangible asset impairment charge |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
112 |
|
|
|
|
|
|
|
Total Operating Expenses |
|
124,928 |
|
|
|
92,412 |
|
|
|
439,845 |
|
|
|
351,668 |
|
|
|
|
|
|
|
Operating Income (Loss) |
|
6,726 |
|
|
|
1,820 |
|
|
|
46,971 |
|
|
|
(35,283 |
) |
|
|
|
|
|
|
Other Expense, net |
|
|
|
|
|
Interest expense, net |
|
(5,746 |
) |
|
|
(7,506 |
) |
|
|
(26,940 |
) |
|
|
(28,052 |
) |
Other (expense) income, net |
|
(33 |
) |
|
|
(42 |
) |
|
|
(159 |
) |
|
|
670 |
|
|
|
|
|
|
|
Income (Loss) Before (Benefit) Expense for Income Taxes |
|
947 |
|
|
|
(5,728 |
) |
|
|
19,872 |
|
|
|
(62,665 |
) |
|
|
|
|
|
|
Income tax (benefit) expense |
|
(208 |
) |
|
|
(1,485 |
) |
|
|
1,093 |
|
|
|
(14,769 |
) |
|
|
|
|
|
|
Net Income (Loss) |
$ |
1,155 |
|
|
$ |
(4,243 |
) |
|
$ |
18,779 |
|
|
$ |
(47,896 |
) |
|
|
|
|
|
|
Dividends on Series A Convertible Preferred Stock |
|
(406 |
) |
|
|
(407 |
) |
|
$ |
(1,625 |
) |
|
|
(1,625 |
) |
|
|
|
|
|
|
Net Income (Loss) Available to Common Shareholders |
$ |
749 |
|
|
$ |
(4,650 |
) |
|
$ |
17,154 |
|
|
$ |
(49,521 |
) |
|
|
|
|
|
|
Basic and Diluted Income (Loss) Per Share: |
|
|
|
|
|
Basic Income (Loss) Per Share |
$ |
0.04 |
|
|
$ |
(0.28 |
) |
|
$ |
0.86 |
|
|
$ |
(3.05 |
) |
Diluted Income (Loss) Per Share |
$ |
0.04 |
|
|
$ |
(0.28 |
) |
|
$ |
0.85 |
|
|
$ |
(3.05 |
) |
|
|
|
|
|
|
Basic Weighted-Average Shares Outstanding |
|
19,003 |
|
|
|
16,325 |
|
|
|
18,001 |
|
|
|
16,260 |
|
Diluted Weighted-Average Shares Outstanding |
|
19,219 |
|
|
|
16,325 |
|
|
|
18,194 |
|
|
|
16,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ANI Pharmaceuticals, Inc. and
SubsidiariesTable 2: US GAAP Balance
Sheets(unaudited, in thousands) |
|
|
December 31,2023 |
December 31,2022 |
|
|
|
Current Assets |
|
|
Cash and cash equivalents |
$ |
221,121 |
|
|
$ |
48,228 |
|
Current restricted cash |
|
- |
|
|
|
5,006 |
|
Accounts receivable, net |
|
162,079 |
|
|
|
165,438 |
|
Inventories |
|
111,196 |
|
|
|
105,355 |
|
Prepaid income taxes |
|
- |
|
|
|
3,827 |
|
Assets held for sale |
|
8,020 |
|
|
|
8,020 |
|
Prepaid expenses and other current assets |
|
17,400 |
|
|
|
8,387 |
|
Total Current Assets |
|
519,816 |
|
|
|
344,261 |
|
Non-current Assets |
|
|
Property and equipment, net |
|
44,593 |
|
|
|
43,246 |
|
Deferred tax assets, net of deferred tax liabilities and valuation
allowance |
|
90,711 |
|
|
|
81,363 |
|
Intangible assets, net |
|
209,009 |
|
|
|
251,635 |
|
Goodwill |
|
28,221 |
|
|
|
28,221 |
|
Derivatives and other non-current assets |
|
12,072 |
|
|
|
11,361 |
|
Total Assets |
$ |
904,422 |
|
|
$ |
760,087 |
|
|
|
|
Current Liabilities |
|
|
Current debt, net of deferred financing costs |
$ |
850 |
|
|
$ |
850 |
|
Accounts payable |
|
36,683 |
|
|
|
29,305 |
|
Accrued royalties |
|
16,276 |
|
|
|
9,307 |
|
Accrued compensation and related expenses |
|
23,786 |
|
|
|
10,312 |
|
Accrued government rebates |
|
12,168 |
|
|
|
10,872 |
|
Income taxes payable |
|
8,164 |
|
|
|
- |
|
Returned goods reserve |
|
29,678 |
|
|
|
33,399 |
|
Current contingent consideration |
|
12,266 |
|
|
|
- |
|
Accrued expenses and other |
|
5,606 |
|
|
|
5,394 |
|
Total Current Liabilities |
|
145,477 |
|
|
|
99,439 |
|
|
|
|
Non-current Liabilities |
|
|
Non-current debt, net of deferred financing costs and current
component |
|
284,819 |
|
|
|
285,669 |
|
Non-current contingent consideration, net of current |
|
11,718 |
|
|
|
35,058 |
|
Other non-current liabilities |
|
4,809 |
|
|
|
1,381 |
|
Total Liabilities |
$ |
446,823 |
|
|
$ |
421,547 |
|
|
|
|
Mezzanine Equity |
|
|
Convertible Preferred Stock, Series A |
|
24,850 |
|
|
|
24,850 |
|
|
|
|
Stockholders’ Equity |
|
|
Common Stock |
|
2 |
|
|
|
1 |
|
Class C Special Stock |
|
- |
|
|
|
- |
|
Preferred Stock |
|
- |
|
|
|
- |
|
Treasury stock |
|
(10,081 |
) |
|
|
(5,094 |
) |
Additional paid-in capital |
|
514,103 |
|
|
|
403,901 |
|
Accumulated deficit |
|
(80,132 |
) |
|
|
(97,286 |
) |
Accumulated other comprehensive income, net of tax |
|
8,857 |
|
|
|
12,168 |
|
Total Stockholders’ Equity |
|
432,749 |
|
|
|
313,690 |
|
|
|
|
Total Liabilities, Mezzanine Equity, and Stockholders’ Equity |
$ |
904,422 |
|
|
$ |
760,087 |
|
|
|
|
|
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 (excluding depreciation and
amortization) |
Selling, general, and administrative |
Research and development |
|
Three MonthsEndedDecember 31, |
|
|
|
Three MonthsEndedDecember 31, |
Three MonthsEndedDecember 31, |
Three MonthsEndedDecember 31, |
Three MonthsEndedDecember 31, |
|
|
2023 |
2022 |
|
|
|
2023 |
2022 |
2023 |
2022 |
2023 |
2022 |
2023 |
2022 |
Net Income (Loss) |
$ 1,155 |
$ (4,243) |
|
As reported: |
|
$ 131,654 |
$ 94,232 |
$ 53,420 |
$ 36,326 |
$ 44,462 |
$ 33,188 |
$ 9,867 |
$ 5,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
5,746 |
7,506 |
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
33 |
42 |
|
|
|
|
|
|
|
|
|
|
|
Benefit for income taxes |
(208) |
(1,485) |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
15,194 |
14,484 |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustment |
1,985 |
1,624 |
|
|
|
|
|
|
|
|
|
|
|
Restructuring activities |
— |
1,568 |
|
|
|
|
|
|
|
|
|
|
|
Impact of Canada operations (1) |
283 |
79 |
|
Impact of Canada operations (1) |
|
— |
(1,227) |
(51) |
(474) |
(232) |
(776) |
— |
(56) |
Stock-based compensation |
5,621 |
3,737 |
|
Stock-based compensation |
|
— |
— |
(185) |
(104) |
(5,196) |
(3,444) |
(240) |
(189) |
Excess of fair value over cost of acquired inventory |
— |
48 |
|
Excess of fair value over cost of acquired inventory |
|
— |
— |
— |
(48) |
— |
— |
— |
— |
Novitium transaction expenses |
391 |
(31) |
|
Novitium transaction expenses |
|
— |
— |
— |
— |
(391) |
31 |
— |
— |
Adjusted non-GAAP EBITDA |
$ 30,200 |
$ 23,329 |
|
As adjusted: |
|
$ 131,654 |
$ 93,005 |
$ 53,184 |
$ 35,700 |
$ 38,643 |
$ 28,999 |
$ 9,627 |
$ 4,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Impact of Canada operations includes CDMO revenues, cost of
sales relating to CDMO revenues, all selling, general, and
administrative expenses, and all research and development expenses
recorded in Canada in the period presented, exclusive of
restructuring activities, stock-based compensation, and
depreciation and amortization, which are included within their
respective line items above. The adjustment of Canada operations
represents revenues, cost of sales and expense that will not recur
after the completion of the closure of our Canada operations
(complete as of March 31, 2023) and the sale of the facility
(on-going as of December 31, 2023). The adjustment of Canada
operations does not adjust for revenues, cost of sales, and expense
that will recur at our other manufacturing facilities after the
transfer of certain manufacturing activities is complete. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of certain adjusted non-GAAP
accounts: |
|
|
|
|
|
|
Net Revenues |
Cost of sales (excluding depreciation and
amortization) |
Selling, general, and administrative |
Research and development |
|
Twelve Months Ended December 31, |
|
|
|
Twelve Months Ended December 31, |
Twelve Months Ended December 31, |
Twelve Months Ended December 31, |
Twelve Months Ended December 31, |
|
|
2023 |
2022 |
|
|
|
2023 |
2022 |
2023 |
2022 |
2023 |
2022 |
2023 |
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss) |
$ 18,779 |
$(47,896) |
|
As reported: |
|
$ 486,816 |
$ 316,385 |
$ 181,513 |
$ 138,785 |
$ 161,697 |
$ 124,044 |
$ 34,286 |
$ 22,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
26,940 |
28,052 |
|
|
|
|
|
|
|
|
|
|
|
Other expense, net (1) |
159 |
80 |
|
|
|
|
|
|
|
|
|
|
|
Expense (benefit) for income taxes |
1,093 |
(14,769) |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
59,791 |
56,972 |
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustment |
1,426 |
3,758 |
|
|
|
|
|
|
|
|
|
|
|
Intangible asset impairment charge |
— |
112 |
|
|
|
|
|
|
|
|
|
|
|
Restructuring activities |
1,132 |
5,679 |
|
|
|
|
|
|
|
|
|
|
|
Impact of Canada operations(2) |
2,697 |
2,740 |
|
Impact of Canada operations(2) |
|
(565) |
(3,241) |
(1,884) |
(2,404) |
(1,304) |
(3,374) |
(73) |
(203) |
Stock-based compensation |
20,652 |
14,599 |
|
Stock-based compensation |
|
— |
— |
(706) |
(546) |
(19,036) |
(13,302) |
(910) |
(751) |
Excess of fair value over cost of acquired inventory |
— |
5,294 |
|
Excess of fair value over cost of acquired inventory |
|
— |
— |
— |
(5,294) |
— |
— |
— |
— |
Novitium transaction expenses |
1,148 |
1,244 |
|
Novitium transaction expenses |
|
— |
— |
— |
— |
(1,148) |
(1,244) |
— |
— |
Adjusted non-GAAP EBITDA |
$ 133,817 |
$ 55,865 |
|
As adjusted: |
|
$ 486,251 |
$ 313,144 |
$ 178,923 |
$ 130,541 |
$ 140,209 |
$ 106,124 |
$ 33,303 |
$ 21,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Adjustment to Other expense, net excludes $750 thousand of
income related to the sale of an ANDA during the twelve months
ended December 31, 2022. |
(2) Impact of Canada operations includes CDMO revenues, cost of
sales relating to CDMO revenues, all selling, general, and
administrative expenses, and all research and development expenses
recorded in Canada in the period presented, exclusive of
restructuring activities, stock-based compensation, and
depreciation and amortization, which are included within their
respective line items above. The adjustment of Canada operations
represents revenues, cost of sales and expense that will not recur
after the completion of the closure of our Canada operations
(complete as of March 31, 2023) and the sale of the facility
(on-going as of December 31, 2023). The adjustment of Canada
operations does not adjust for revenues, cost of sales, and expense
that will recur at our other manufacturing facilities after the
transfer of certain manufacturing activities is complete. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 December 31, |
Twelve Months Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Net Income (Loss) Available to Common Shareholders |
$ |
749 |
|
|
$ |
(4,650 |
) |
|
$ |
17,154 |
|
|
$ |
(49,521 |
) |
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
Non-cash interest expense |
|
804 |
|
|
|
982 |
|
|
|
3,335 |
|
|
|
3,865 |
|
Depreciation and amortization |
|
15,194 |
|
|
|
14,484 |
|
|
|
59,791 |
|
|
|
56,972 |
|
Contingent consideration fair value adjustment |
|
1,985 |
|
|
|
1,624 |
|
|
|
1,426 |
|
|
|
3,758 |
|
Restructuring activities |
|
— |
|
|
|
1,568 |
|
|
|
1,132 |
|
|
|
5,679 |
|
Intangible asset impairment charge |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
112 |
|
Impact of Canada operations (1) |
|
283 |
|
|
|
79 |
|
|
|
2,697 |
|
|
|
2,740 |
|
Stock-based compensation |
|
5,621 |
|
|
|
3,737 |
|
|
|
20,652 |
|
|
|
14,599 |
|
Excess of fair value over cost of acquired inventory |
|
— |
|
|
|
48 |
|
|
|
— |
|
|
|
5,294 |
|
Novitium transaction expenses |
|
391 |
|
|
|
(31 |
) |
|
|
1,148 |
|
|
|
1,244 |
|
Less: |
|
|
|
|
Estimated tax impact of adjustments (calc. at 24%) |
|
(5,827 |
) |
|
|
(5,398 |
) |
|
|
(21,643 |
) |
|
|
(22,623 |
) |
|
|
|
|
|
Adjusted non-GAAP Net Income Available to Common Shareholders
(2) |
$ |
19,200 |
|
|
$ |
12,443 |
|
|
$ |
85,692 |
|
|
$ |
22,119 |
|
Diluted Weighted-Average |
|
|
|
|
Shares Outstanding |
|
19,219 |
|
|
|
16,325 |
|
|
|
18,194 |
|
|
|
16,260 |
|
Adjusted Diluted Weighted-Average |
|
|
|
|
Shares Outstanding |
|
19,219 |
|
|
|
16,357 |
|
|
|
18,194 |
|
|
|
16,282 |
|
|
|
|
|
|
Adjusted non-GAAP |
|
|
|
|
Diluted Earnings per Share |
$ |
1.00 |
|
|
$ |
0.76 |
|
|
$ |
4.71 |
|
|
$ |
1.36 |
|
|
|
|
|
|
(1) Impact of Canada operations includes CDMO revenues, cost
of sales relating to CDMO revenues, all selling, general, and
administrative expenses, and all research and development expenses
recorded in Canada in the period presented, exclusive of
restructuring activities, stock-based compensation, and
depreciation and amortization, which are included within their
respective line items above. The adjustment of Canada operations
represents revenues, cost of sales and expense that will not recur
after the completion of the closure of our Canada operations
(complete as of March 31, 2023) and the sale of the facility
(on-going as of December 31, 2023). The adjustment of Canada
operations does not adjust for revenues, cost of sales, and expense
that will recur at our other manufacturing facilities after the
transfer of certain manufacturing activities is complete. |
|
|
|
|
|
(2) Adjusted non-GAAP Net Income (Loss) Available to Common
Shareholders excludes undistributed earnings to participating
securities. |
|
|
|
|
|
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