ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today
announced financial results and business highlights for the three
months ended June 30, 2024.
“We are very proud of our accomplishments in the
second quarter. We delivered both record revenues and a major
milestone in our ongoing efforts to expand the scope and scale of
our Rare Disease business with the proposed acquisition of
Alimera,” said Nikhil Lalwani, President & CEO of ANI. “Rare
Disease continues to be ANI's primary growth driver, and the
strategic investments we’ve made in our Cortrophin Gel franchise
have been yielding positive results. During the second quarter, we
achieved the highest number of both new patient starts and unique
prescribers since our January 2022 launch and continued to have
momentum across all targeted specialties.”
“Our Generics business also delivered a strong
quarter, with high-teens growth stemming from the strength of our
base business, our operational excellence and our ability to
consistently and effectively launch new products. Based on our
solid second quarter results and the continued momentum we’re
seeing across the business, we are raising our full year 2024
guidance.”
“Following the acquisition of Alimera, ANI will
have three growing and durable commercial Rare Disease assets, an
expanded commercial team covering five specialties, and a global
infrastructure covering over 20 countries. We’re pleased with our
progress thus far in 2024 and are excited about the opportunities
that lie ahead, as we make further strides in our mission of
‘Serving Patients, Improving Lives’,” concluded Mr. Lalwani.
Second Quarter and Recent Business
Highlights:
Rare Disease Segment
Revenues for the Company’s lead asset, Cortrophin
Gel, totaled $49.2 million for the second quarter of 2024, an
increase of 102.4% over the same period in 2023, driven primarily
by increased volume. During the quarter, the Company saw increasing
prescription demand and new patient starts across all targeted
specialties – neurology, rheumatology, nephrology, pulmonology, and
ophthalmology. The Company saw particularly strong year-over-year
and quarter-over-quarter demand for acute gouty arthritis flares,
which is proprietary to Cortrophin Gel as the only ACTH product
approved for this indication. In addition, the newly established
ophthalmology sales team drove significant growth in prescriptions
and new patient starts in the second quarter.
On June 24, 2024, the Company announced that it had
entered into a definitive agreement to acquire Alimera Sciences for
$5.50 per share in cash at closing and one non-tradable contingent
value right (CVR), representing the right to receive up to $0.50
per share upon the achievement of certain net revenue targets in
2026 and 2027. The transaction will expand the scope and scale of
ANI’s Rare Disease business with two growing and durable
ophthalmology products, ILUVIEN and YUTIQ.
The Company anticipates completing the acquisition
during the third quarter of 2024.
Generics, Established Brands and Other Segment
Revenues for generic pharmaceuticals products,
established brands and other decreased 3.7% year-over-year in the
second quarter of 2024 as growth in Generics was more than offset
by an anticipated decline for Established Brands. ANI’s Generics
business launched four new products during the quarter, each into
limited competition markets, and two additional products in July.
The Company also made substantial progress on bringing online the
significant capacity expansion at our New Jersey site, which will
support the future growth of its Generics business.
Second Quarter 2024 Financial
Results
|
|
Three Months Ended June 30, |
|
|
|
|
(in thousands) |
|
2024 |
|
2023 |
|
Change |
|
% Change |
Generics, Established Brands, and Other
Segment |
|
|
|
|
|
|
|
|
Generic pharmaceutical products |
|
$ |
73,964 |
|
|
$ |
63,317 |
|
|
$ |
10,647 |
|
|
16.8 |
% |
Established brand pharmaceutical products, royalties, and other
pharmaceutical services |
|
|
14,883 |
|
|
|
28,926 |
|
|
|
(14,043 |
) |
|
(48.5 |
)% |
Generics, established brands, and other segment total net
revenues |
|
$ |
88,847 |
|
|
$ |
92,243 |
|
|
$ |
(3,396 |
) |
|
(3.7 |
)% |
Rare Disease Segment |
|
|
|
|
|
|
|
|
Rare disease pharmaceutical products |
|
|
49,193 |
|
|
|
24,304 |
|
|
|
24,889 |
|
|
102.4 |
% |
Total net revenues |
|
$ |
138,040 |
|
|
$ |
116,547 |
|
|
$ |
21,493 |
|
|
18.4 |
% |
Net revenues for generic pharmaceutical products
were $74.0 million, an increase of 16.8% year-over-year, driven by
increased volumes in the base business and contribution from new
product launches.
Net revenues for established brand pharmaceutical
products, royalties, and other pharmaceutical services were $14.9
million, a decrease of 48.5% year-over-year, in line with Company
expectations. The prior-year quarter included revenues resulting
from ANI’s ability to respond to pharmaceutical shortages in the
U.S. market.
Net revenues for Rare Disease pharmaceutical
products, which consist entirely of sales of Cortrophin Gel, were
$49.2 million, an increase of 102.4% year-over-year driven by
increased volume.
Operating expenses were $132.9 million, an increase
of 27.6% year-over-year, as a result of the following factors:
- Cost of sales increased 36.5%
year-over-year to $57.7 million, primarily due to significant net
growth in sales volumes of pharmaceutical products and significant
growth of royalty bearing products, including Cortrophin Gel.
- Research and development expenses
decreased 1.1% year-over-year to $7.3 million.
- Selling, general, and administrative
expenses increased 36.3% year-over-year to $52.8 million, primarily
due to increased employment-related costs, investment in our Rare
Disease sales and marketing infrastructure and activities, legal
expenses, expenses related to the pending acquisition of Alimera,
and an overall increase in activities to support revenue
growth.
Net loss available to common shareholders for the
second quarter of 2024 was $(2.7) million as compared to net income
of $5.8 million in the prior year period. Diluted GAAP loss per
share for the second quarter of 2024 was $(0.14) compared to net
income per share of $0.29 in the prior year period.
Adjusted non-GAAP EBITDA for the second quarter of
2024 was $33.2 million, a decrease of 2.6% over the second quarter
of 2023.
Adjusted non-GAAP diluted earnings per share was
$1.02 in the second quarter of 2024 compared to $1.28 in the prior
year period.
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 June 30, 2024, the Company had $240.1 million
in unrestricted cash and cash equivalents, $166.1 million in net
accounts receivable and $292.5 million (face value) in outstanding
debt. The Company generated year-to-date cash flow from operations
of $35.7 million.
Revised Full Year 2024
Guidance:
The following guidance for 2024 does not include
contribution from the pending acquisition of Alimera.
|
|
Revised Full Year 2024 Guidance |
|
Prior Full Year 2024 Guidance |
|
2023 Actual |
|
Growth |
Net Revenue (Total Company) |
|
$540 million - $560 million |
|
$520 million - $542 million |
|
$486.8 million |
|
11% - 15% |
Cortrophin Gel Net Revenue |
|
$185 million - $195 million |
|
$170 million - $180 million |
|
$112.1 million |
|
65% - 74% |
Adjusted Non-GAAP EBITDA |
|
$140 million - $150 million |
|
$135 million - $145 million |
|
$133.8 million |
|
5% - 12% |
Adjusted Non-GAAP Diluted EPS |
|
$4.38 - $4.82 |
|
$4.26 - $4.67 |
|
$4.71 |
|
(7)% - 2% |
ANI now expects total company adjusted non-GAAP
gross margin between 61% and 62% as compared to our previous
expectation of 62% and 63%. The Company will continue to tax effect
non-GAAP adjustments for computation of adjusted non-GAAP diluted
earnings per share at a tax rate of 26.0%.
The Company now anticipates between 19.4 million
and 19.8 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 continues to expect its
U.S. GAAP effective tax rate to be between 22.0% to 25.0%.
Conference Call
The Company’s management will host a conference
call today to discuss its second quarter 2024 results.
Date |
Tuesday, August 6, 2024 |
Time |
8:30 a.m. ET |
Toll free (U.S.) |
800-245-3047 |
|
|
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 800-753-5212 and entering
access code 4619279.
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 provision or benefit, interest expense,
(net), other expense, (net), depreciation and amortization expense,
non-cash stock-based compensation expense, M&A transaction
expenses, contingent consideration fair value adjustment,
unrealized gain on our investment in equity securities, gain on
sale of the former Oakville, Ontario manufacturing site, litigation
expenses related to certain matters, 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
ANI’s management considers adjusted non-GAAP net
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 non-cash stock-based
compensation, non-cash interest expense, depreciation and
amortization, M&A transaction expenses, contingent
consideration fair value adjustment, unrealized gain on our
investment in equity securities, gain on sale of the former
Oakville, Ontario manufacturing site, litigation expenses related
to certain matters, and certain other items that vary in frequency
and impact on ANI’s results of operations. Management uses adjusted
non-GAAP net income when analyzing Company performance.
Adjusted non-GAAP net income is defined as net
(loss) income, plus the non-cash stock-based compensation expense,
M&A transaction expenses, non-cash interest expense,
depreciation and amortization expense, contingent consideration
fair value adjustment, unrealized gain on our investment in equity
securities, gain on sale of the former Oakville, Ontario
manufacturing site, litigation expenses related to certain matters,
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 should
be considered in addition to, but not in lieu of, net income
reported under GAAP. A reconciliation of adjusted non-GAAP net
income to the most directly comparable GAAP financial measure is
provided below.
Adjusted non-GAAP Diluted Earnings per
Share
ANI’s management considers adjusted non-GAAP
diluted 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
non-cash stock-based compensation, non-cash interest expense,
depreciation and amortization, M&A transaction expenses,
contingent consideration fair value adjustment, unrealized gain on
our investment in equity securities, gain on sale of the former
Oakville, Ontario manufacturing site, litigation expenses related
to certain matters, and certain other items that vary in frequency
and impact on ANI’s results of operations. Management uses adjusted
non-GAAP diluted earnings per share when analyzing Company
performance.
Adjusted non-GAAP diluted earnings per share is
defined as adjusted non-GAAP net 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 earnings per share should be considered in addition to, but
not in lieu of, diluted earnings per share reported under GAAP. A
reconciliation of adjusted non-GAAP diluted earnings 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: our ability to continue to achieve
commercial success with Cortrophin Gel, our first rare disease
pharmaceutical product, including expanding the market and gaining
market share, our business, financial condition, and results of
operations will be negatively impacted; the ability of our approved
products, including Cortrophin Gel, to achieve commercialization at
levels of market acceptance that will continue to allow us to
achieve profitability; our ability to complete or achieve any, or
all of the intended benefits of acquisitions and investments,
including the pending acquisition of Alimera, in a timely manner or
at all; the risks that our acquisitions and investments, including
the pending acquisition of Alimera, could disrupt our business and
harm our financial position and operating results; delays in
production, increased costs and potential loss of revenues if we
need to change suppliers due to the limited number of suppliers for
our raw materials, active pharmaceutical ingredients, excipients
and other materials; our reliance on single source third-party
contract manufacturing supply for certain of our key products,
including Cortrophin Gel, and post-consummation of the proposed
acquisition of Alimera, for Alimera’s products; delays or failure
in obtaining and maintaining approvals by the FDA of the products
we sell; changes in policy or actions that may be taken by the FDA,
United States Drug Enforcement Administration, and other regulatory
agencies, including among other things, drug recalls, regulatory
approvals, facility inspections and potential enforcement actions;
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; 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,
conflicts related to the attacks on cargo ships in the Red Sea, and
the effects and duration of outbreaks of public health emergencies,
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.
212-452-2793lwilson@insitecony.com
SOURCE: ANI Pharmaceuticals, Inc.
FINANCIAL TABLES FOLLOW
ANI Pharmaceuticals, Inc. and Subsidiaries |
Table 1: US GAAP Statements of Operations |
(unaudited, in thousands, except per share amounts) |
|
|
|
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Net Revenues |
$ |
138,040 |
|
$ |
116,547 |
|
$ |
275,470 |
|
$ |
223,333 |
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
Cost of sales (excluding depreciation and amortization) |
|
57,698 |
|
|
42,284 |
|
|
106,855 |
|
|
79,992 |
|
Research and development |
|
7,296 |
|
|
7,374 |
|
|
17,807 |
|
|
13,298 |
|
Selling, general, and administrative |
|
52,821 |
|
|
38,760 |
|
|
100,842 |
|
|
75,228 |
|
Depreciation and amortization |
|
14,697 |
|
|
14,690 |
|
|
29,383 |
|
|
29,390 |
|
Contingent consideration fair value adjustment |
|
359 |
|
|
1,035 |
|
|
449 |
|
|
1,996 |
|
Restructuring activities |
|
- |
|
|
2 |
|
|
- |
|
|
1,132 |
|
Gain on sale of building |
|
- |
|
|
- |
|
|
(5,347 |
) |
|
- |
|
|
|
|
|
|
Total Operating Expenses, net |
|
132,871 |
|
|
104,145 |
|
|
249,989 |
|
|
201,036 |
|
|
|
|
|
|
Operating Income |
|
5,169 |
|
|
12,402 |
|
|
25,481 |
|
|
22,297 |
|
|
|
|
|
|
Other Income (Expense),
net |
|
|
|
|
Unrealized (loss) gain on investment in equity securities |
|
(2,712 |
) |
|
- |
|
|
6,943 |
|
|
- |
|
Interest expense, net |
|
(4,656 |
) |
|
(7,100 |
) |
|
(9,256 |
) |
|
(14,796 |
) |
Other expense, net |
|
(88 |
) |
|
(53 |
) |
|
(120 |
) |
|
(87 |
) |
|
|
|
|
|
(Loss) Income Before Income Tax Expense (Benefit) |
|
(2,287 |
) |
|
5,249 |
|
|
23,048 |
|
|
7,414 |
|
|
|
|
|
|
Income tax expense
(benefit) |
|
- |
|
|
(996 |
) |
|
7,128 |
|
|
(270 |
) |
|
|
|
|
|
Net (Loss) Income |
$ |
(2,287 |
) |
$ |
6,245 |
|
$ |
15,920 |
|
$ |
7,684 |
|
|
|
|
|
|
Dividends on Series A Convertible Preferred Stock |
|
(407 |
) |
|
(407 |
) |
|
(813 |
) |
|
(813 |
) |
|
|
|
|
|
Net (Loss) Income Available to Common Shareholders |
$ |
(2,694 |
) |
$ |
5,838 |
|
$ |
15,107 |
|
$ |
6,871 |
|
|
|
|
|
|
Basic and Diluted
(Loss) Income Per Share: |
|
|
|
|
Basic (Loss) Income Per
Share |
$ |
(0.14 |
) |
$ |
0.30 |
|
$ |
0.71 |
|
$ |
0.36 |
|
Diluted (Loss) Income Per
Share |
$ |
(0.14 |
) |
$ |
0.29 |
|
$ |
0.70 |
|
$ |
0.36 |
|
|
|
|
|
|
Basic Weighted-Average Shares
Outstanding |
|
19,321 |
|
|
17,688 |
|
|
19,210 |
|
|
17,044 |
|
Diluted Weighted-Average
Shares Outstanding |
|
19,321 |
|
|
17,855 |
|
|
19,561 |
|
|
17,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANI Pharmaceuticals, Inc. and Subsidiaries |
Table 2: US GAAP Balance Sheets |
(unaudited, in thousands) |
|
|
June 30,2024 |
December 31,2023 |
Current
Assets |
|
|
Cash and cash equivalents |
$ |
240,110 |
|
$ |
221,121 |
|
Accounts receivable, net |
|
166,091 |
|
|
162,079 |
|
Inventories |
|
125,448 |
|
|
111,196 |
|
Prepaid income taxes |
|
2,867 |
|
|
- |
|
Assets held for sale |
|
- |
|
|
8,020 |
|
Prepaid expenses and other current assets |
|
14,001 |
|
|
17,400 |
|
Investment in equity securities |
|
6,943 |
|
|
- |
|
Total Current Assets |
|
555,460 |
|
|
519,816 |
|
Non-current Assets |
|
|
Property and equipment, net |
|
51,640 |
|
|
44,593 |
|
Deferred tax assets, net of deferred tax liabilities and valuation
allowance |
|
89,506 |
|
|
90,711 |
|
Intangible assets, net |
|
183,078 |
|
|
209,009 |
|
Goodwill |
|
28,221 |
|
|
28,221 |
|
Derivatives and other non-current assets |
|
12,848 |
|
|
12,072 |
|
Total Assets |
$ |
920,753 |
|
$ |
904,422 |
|
|
|
|
Current
Liabilities |
|
|
Current debt, net of deferred financing costs |
$ |
850 |
|
$ |
850 |
|
Accounts payable |
|
48,681 |
|
|
36,683 |
|
Accrued royalties |
|
20,357 |
|
|
16,276 |
|
Accrued compensation and related expenses |
|
16,111 |
|
|
23,786 |
|
Accrued government rebates |
|
12,324 |
|
|
12,168 |
|
Income taxes payable |
|
- |
|
|
8,164 |
|
Returned goods reserve |
|
33,897 |
|
|
29,678 |
|
Current contingent consideration |
|
841 |
|
|
12,266 |
|
Accrued expenses and other |
|
6,917 |
|
|
5,606 |
|
Total Current Liabilities |
|
139,978 |
|
|
145,477 |
|
|
|
|
Non-current Liabilities |
|
|
Non-current debt, net of deferred financing costs and current
component |
|
284,394 |
|
|
284,819 |
|
Non-current contingent consideration |
|
11,092 |
|
|
11,718 |
|
Other non-current liabilities |
|
4,679 |
|
|
4,809 |
|
Total Liabilities |
$ |
440,143 |
|
$ |
446,823 |
|
|
|
|
Mezzanine Equity |
|
|
Convertible Preferred Stock, Series A |
|
24,850 |
|
|
24,850 |
|
|
|
|
Stockholders’ Equity |
|
|
Common Stock |
|
2 |
|
|
2 |
|
Class C Special Stock |
|
- |
|
|
- |
|
Preferred Stock |
|
- |
|
|
- |
|
Treasury stock |
|
(20,042 |
) |
|
(10,081 |
) |
Additional paid-in capital |
|
532,497 |
|
|
514,103 |
|
Accumulated deficit |
|
(65,025 |
) |
|
(80,132 |
) |
Accumulated other comprehensive income, net of tax |
|
8,328 |
|
|
8,857 |
|
Total Stockholders’ Equity |
|
455,760 |
|
|
432,749 |
|
|
|
|
Total Liabilities, Mezzanine Equity, and Stockholders’
Equity |
$ |
920,753 |
|
$ |
904,422 |
|
|
|
|
|
|
|
|
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 Months EndedJune 30, |
|
|
|
Three MonthsEndedJune 30, |
Three MonthsEndedJune 30, |
Three MonthsEndedJune 30, |
Three MonthsEndedJune 30, |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Net (Loss) Income |
$ |
(2,287 |
) |
$ |
6,245 |
|
|
As reported: |
|
$ |
138,040 |
|
$ |
116,547 |
|
$ |
57,698 |
|
$ |
42,284 |
|
$ |
52,821 |
|
$ |
38,760 |
|
$ |
7,296 |
|
$ |
7,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
4,656 |
|
|
7,100 |
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
88 |
|
|
53 |
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for income taxes |
|
— |
|
|
(996 |
) |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
14,697 |
|
|
14,690 |
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustment |
|
359 |
|
|
1,035 |
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring activities |
|
— |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investment in equity securities |
|
2,712 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Impact of Canada operations (1) |
|
— |
|
|
492 |
|
|
Impact of Canada operations
(1) |
|
|
— |
|
|
— |
|
|
— |
|
|
(289 |
) |
|
— |
|
|
(194 |
) |
|
— |
|
|
(9 |
) |
Stock-based compensation |
|
7,864 |
|
|
5,249 |
|
|
Stock-based compensation |
|
|
— |
|
|
— |
|
|
(312 |
) |
|
(188 |
) |
|
(7,206 |
) |
|
(4,836 |
) |
|
(346 |
) |
|
(225 |
) |
M&A transaction expenses |
|
3,540 |
|
|
249 |
|
|
M&A transaction
expenses |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(3,540 |
) |
|
(249 |
) |
|
— |
|
|
— |
|
Litigation expenses |
|
1,594 |
|
|
— |
|
|
Litigation expenses |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,594 |
) |
|
— |
|
|
— |
|
|
— |
|
Adjusted non-GAAP EBITDA |
$ |
33,223 |
|
$ |
34,119 |
|
|
As adjusted: |
|
$ |
138,040 |
|
$ |
116,547 |
|
$ |
57,386 |
|
$ |
41,807 |
|
$ |
40,481 |
|
$ |
33,481 |
|
$ |
6,950 |
|
$ |
7,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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
(complete as of March 31, 2024). 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 |
|
Six Months EndedJune 30, |
|
|
|
Six MonthsEndedJune 30, |
Six MonthsEndedJune 30, |
Six MonthsEndedJune 30, |
Six MonthsEndedJune 30, |
|
|
2024 |
|
|
2023 |
|
|
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Net Income |
$ |
15,920 |
|
$ |
7,684 |
|
|
As reported: |
|
$ |
275,470 |
|
$ |
223,333 |
|
$ |
106,855 |
|
$ |
79,992 |
|
$ |
100,842 |
|
$ |
75,228 |
|
$ |
17,807 |
|
$ |
13,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
9,256 |
|
|
14,796 |
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
120 |
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for income taxes |
|
7,128 |
|
|
(270 |
) |
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
29,383 |
|
|
29,390 |
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustment |
|
449 |
|
|
1,996 |
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring activities |
|
— |
|
|
1,132 |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of building |
|
(5,347 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investment in equity securities |
|
(6,943 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Impact of Canada operations (1) |
|
— |
|
|
2,138 |
|
|
Impact of Canada operations
(1) |
|
|
— |
|
|
(565 |
) |
|
— |
|
|
(1,705 |
) |
|
— |
|
|
(925 |
) |
|
— |
|
|
(73 |
) |
Stock-based compensation |
|
14,798 |
|
|
9,587 |
|
|
Stock-based compensation |
|
|
— |
|
|
— |
|
|
(592 |
) |
|
(339 |
) |
|
(13,577 |
) |
|
(8,816 |
) |
|
(629 |
) |
|
(432 |
) |
M&A transaction expenses |
|
4,253 |
|
|
591 |
|
|
M&A transaction
expenses |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(4,253 |
) |
|
(591 |
) |
|
— |
|
|
— |
|
Litigation expenses |
|
1,839 |
|
|
— |
|
|
Litigation expenses |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,839 |
) |
|
— |
|
|
— |
|
|
— |
|
Adjusted non-GAAP EBITDA |
$ |
70,856 |
|
$ |
67,131 |
|
|
As adjusted: |
|
$ |
275,470 |
|
$ |
222,768 |
|
$ |
106,263 |
|
$ |
77,948 |
|
$ |
81,173 |
|
$ |
64,896 |
|
$ |
17,178 |
|
$ |
12,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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
(complete as of March 31, 2024). 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 June 30, |
Six Months Ended June 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Net (Loss) Income Available to
Common Shareholders |
$ |
(2,694 |
) |
$ |
5,838 |
|
$ |
15,107 |
|
$ |
6,871 |
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
Non-cash interest (income) expense |
|
(55 |
) |
|
710 |
|
|
(65 |
) |
|
1,675 |
|
Depreciation and amortization |
|
14,697 |
|
|
14,690 |
|
|
29,383 |
|
|
29,390 |
|
Contingent consideration fair value adjustment |
|
359 |
|
|
1,035 |
|
|
449 |
|
|
1,996 |
|
Restructuring activities |
|
— |
|
|
2 |
|
|
— |
|
|
1,132 |
|
Gain on sale of building |
|
— |
|
|
— |
|
|
(5,347 |
) |
|
— |
|
Unrealized loss (gain) on investment in equity securities |
|
2,712 |
|
|
— |
|
|
(6,943 |
) |
|
— |
|
Impact of Canada operations (1) |
|
— |
|
|
492 |
|
|
— |
|
|
2,138 |
|
Stock-based compensation |
|
7,864 |
|
|
5,249 |
|
|
14,798 |
|
|
9,587 |
|
M&A transaction expenses |
|
3,540 |
|
|
249 |
|
|
4,253 |
|
|
591 |
|
Litigation expenses |
|
1,594 |
|
|
— |
|
|
1,839 |
|
|
— |
|
Less: |
|
|
|
|
Estimated tax impact of adjustments (calc. at 26% and 24% for the
three and six months ended June 30, 2024 and 2023,
respectively) |
|
(7,985 |
) |
|
(5,382 |
) |
|
(9,975 |
) |
|
(11,162 |
) |
|
|
|
|
|
Adjusted non-GAAP Net Income
Available to Common Shareholders (2) |
$ |
20,032 |
|
$ |
22,883 |
|
$ |
43,499 |
|
$ |
42,218 |
|
Diluted
Weighted-Average |
|
|
|
|
Shares Outstanding |
|
19,321 |
|
|
17,855 |
|
|
19,561 |
|
|
17,177 |
|
Adjusted Diluted
Weighted-Average |
|
|
|
|
Shares Outstanding |
|
19,686 |
|
|
17,855 |
|
|
19,561 |
|
|
17,177 |
|
|
|
|
|
|
Adjusted non-GAAP |
|
|
|
|
Diluted Earnings per Share |
$ |
1.02 |
|
$ |
1.28 |
|
$ |
2.22 |
|
$ |
2.46 |
|
|
|
|
|
|
(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
(complete as of March 31, 2024). 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 Available to Common
Shareholders excludes undistributed earnings to participating
securities.
ANI Pharmaceuticals (NASDAQ:ANIP)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
ANI Pharmaceuticals (NASDAQ:ANIP)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024