ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today
announced business highlights and financial results for the three
months ended September 30, 2023.
Nikhil Lalwani, President and CEO of ANI stated, “Strong
execution has resulted in another record quarter for revenue and
adjusted non-GAAP EBITDA, positioning us to raise full year 2023
guidance for the third consecutive quarter. Launch momentum of our
lead Rare Disease asset, Purified Cortrophin Gel, continues to
accelerate, with record quarterly new cases initiated and new
patient starts, and increasing momentum with new unique
prescribers, including many prescribers who were naive to ACTH
therapy. In addition, the Company has received positive initial
physician response in our new areas of pulmonology and acute gouty
arthritis. We remain committed to increasing the scope and scale of
our Rare Disease portfolio and believe that the strength of our
financial results and cash flow position us well for targeted
M&A and in-licensing.”
“Our Generics and Established Brands businesses also performed
well, delivering record quarterly revenues, and we continued to
leverage our operational excellence and U.S.-based manufacturing
footprint to serve patients facing pharmaceutical shortages due to
supply chain disruptions. While we see softening of specific market
opportunities that persisted in prior quarters, we believe we are
poised to capitalize on current and future opportunities as a
partner of choice for our customers. Our strong R&D
capabilities were further demonstrated through the launch of five
new products as well as the filing of three ANDAs and two 505(b)2
applications during the quarter. As we approach the end of 2023, I
believe that our efforts during the year have created a strong
foundation for continued success and fulfilling our purpose of
Serving Patients, Improving Lives,” concluded Lalwani.
Third Quarter 2023 Financial Highlights:
- Net revenues were $131.8 million compared to $83.8 million in
Q3 2022.
- GAAP net income available to common shareholders was $9.5
million, and diluted GAAP income per share was $0.45.
- Adjusted non-GAAP EBITDA was $36.5 million compared to $18.4
million in Q3 2022.
- Adjusted non-GAAP diluted earnings per share was $1.27,
compared to diluted earnings per share of $0.58 in Q3 2022.
- Cash and cash equivalents were $193.1 million with year-to-date
(nine month) cash flow from operations of $74.2 million.
Third Quarter and Recent Business
Highlights:
Rare Disease Business Update
Revenues for our lead asset, Cortrophin Gel, totaled $29.7
million for the third quarter of 2023, an increase of 135.9% over
the same period in 2022, driven by increased volume in this second
year of launch. During the quarter, the Company achieved a record
number of new cases initiated and new patient starts, and a
continued increase in the number of new unique and repeat
prescribers. Many of the new unique prescribers were naive to ACTH
therapy. We believe the Company’s efforts to increase effectiveness
of the field sales force and improve awareness of ACTH therapy for
appropriate patients have yielded results. Since the launch of
Cortrophin Gel, the overall ACTH category has experienced six
consecutive quarters of year-over-year growth from second quarter
2022 to third quarter 2023.
Growth continued across both the initially targeted specialties
of neurology, rheumatology, and nephrology, and two new areas. The
Company saw positive physician response and momentum in
pulmonology, a focus area that was initiated in the second quarter
of 2023. The Company also announced the FDA approval and commercial
availability of a 1-mL vial size of Purified Cortrophin® Gel for
adjunctive treatment of certain patients with acute gouty arthritis
flares. Recently, the Company received a specific J-Code for
Cortrophin to support physician administration of the 1 ml vial.
The commercial launch of the 1 ml vial is supported by ANI’s
existing field sales force.
The Company is raising its 2023 revenue guidance for Cortrophin
Gel to $100 million to $107 million, representing 139.9% - 156.7%
year-over-year growth.
We continue to believe that Rare Disease remains ANI’s largest
future growth driver, and the Company is actively exploring
opportunities to acquire assets and/or establish partnerships to
increase the scope and scale of its Rare Disease platform.
Generics Business, Established Brands and Other Update
Sales of generic pharmaceuticals products, established brands
and other grew 43.4% year-over-year in the third quarter of 2023.
We believe that the Company’s generics business is well positioned
for delivering sustainable growth, driven by a strong R&D
organization launching new products, cost competitiveness and
supply reliability. During the quarter, ANI launched five products,
including Colestipol Hydrochloride Tablets, Estradiol Gel, 0.1% and
Thyroid Tablets, USP, filed five new ANDAs and two 505(b)2
applications, while maintaining its number two ranking in
Competitive Generic Therapy approvals.
ANI continued to leverage its operational excellence and
U.S.-based manufacturing during the quarter to take advantage of
certain opportunities arising from supply disruptions in both
generics and established brands. Recently, certain of these market
conditions changed, and as a result, we expect fourth quarter 2023
demand and resultant revenues for certain generic and established
brand products to be significantly lower as compared to the rate
achieved during the first nine months of 2023. We remain well
positioned to take advantage of current and future opportunities
when they arise. In fact, to support the ongoing growth of the
Generics, Established Brands and Other business segment, the
Company has invested in expanding the manufacturing footprint and
capacities at its New Jersey facility and expects these to be
operational by early 2024.
Third Quarter 2023 Financial Results
|
|
Three Months Ended September 30, |
|
|
|
|
(in
thousands) |
|
|
2023 |
|
|
2022 |
|
Change |
|
% Change |
Generics, Established Brands, and Other
Segment |
|
|
|
|
|
|
|
|
Generic pharmaceutical products |
|
$ |
70,593 |
|
$ |
53,136 |
|
$ |
17,457 |
|
32.9 |
% |
Established brand pharmaceutical products, royalties, and other
pharmaceutical services |
|
|
31,502 |
|
|
18,083 |
|
|
13,419 |
|
74.2 |
% |
Generics, established brands, and other segment total net
revenues |
|
$ |
102,095 |
|
$ |
71,219 |
|
$ |
30,876 |
|
43.4 |
% |
Rare Disease
Segment |
|
|
|
|
|
|
|
|
Rare disease pharmaceutical products |
|
|
29,734 |
|
|
12,602 |
|
|
17,132 |
|
135.9 |
% |
Total net revenues |
|
$ |
131,829 |
|
$ |
83,821 |
|
$ |
48,008 |
|
57.3 |
% |
Net revenues for generic pharmaceutical products were $70.6
million during the three months ended September 30, 2023, an
increase of 32.9% compared to $53.1 million for the same period in
2022, driven by increased volumes on the base business and the
inclusion of 2022 launches and new product launches in 2023. From a
product perspective, the increase was principally driven by
revenues from year over year increases in products such as
Colestipol, Famotidine, Mixed Amphetamine Salts Extended Release,
Nitrofurantoin, Thyroid and various other products tempered by a
decrease in revenues of Fenofibrate, Nebivolol, and Prazosin, among
others.
Net revenues for established brand pharmaceutical products,
royalties, and other pharmaceutical services were $31.5 million
during the three months ended September 30, 2023, an increase of
74.2% compared to $18.1 million for the same period in 2022, driven
by a net increase in volume.
Net revenues of Rare Disease pharmaceutical products, which
consist entirely of sales of Cortrophin Gel, were $29.7 million
during the three months ended September 30, 2023, an increase of
$17.1 million from $12.6 million for the same period in 2022. This
increase was driven by increased volume in this second year of
launch (product was launched in late January 2022).
Operating expenses increased by 28.2% to $113.9 million for the
three months ended September 30, 2023, from $88.8 million in the
prior year period as a result of the following factors:
For the three months ended September 30, 2023, cost of sales
increased to $48.1 million from $32.9 million for the same period
in 2022, an increase of $15.2 million, or 46.2%, primarily due to a
significant growth in sales volumes of generic and Rare Disease
pharmaceutical products.
Research and development expenses increased from $7.7 million to
$11.1 million for the three months ended September 30, 2023, an
increase of $3.5 million or 45.2%, primarily due to expenses
related to a 505(b)(2) filing for one product of approximately $1.6
million, and a higher level of activity associated with ongoing and
new projects in the three months ended September 30, 2023.
Selling, general, and administrative expenses increased from
$30.1 million to $42.0 million for the three months ended September
30, 2023, an increase of $11.9 million, or 39.6%, primarily due to
increased employment related costs, legal expenses, as well as an
overall increase in activities required to support the growth in
our business.
Depreciation and amortization expense was $15.2 million for the
three months ended September 30, 2023, compared to $14.2 million
for the same period in 2022, an increase of $1.0 million, primarily
due to the amortization of intangible assets acquired in the
Slayback and Akorn asset acquisitions, and amortization of acquired
in-process research, and development ("IPR&D") which commenced
during the quarter.
We recognized a gain of $(2.6) million and loss of $2.5 million
in the three months ended September 30, 2023 and 2022,
respectively, for the contingent consideration fair value
adjustment. The change in the fair value adjustment is primarily
related to a change in the anticipated cash flows, specifically
extending the timeframe over which cash flows will be generated by
the products, and the passage of time (i.e., moving closer to the
anticipated payment date of the consideration), and an increase to
the probability of payment for the product development-based
milestone payments.
The Company recognized restructuring activities of $1.5 million
of expense in the three months ended September 30, 2022, in
relation to the closure of its Oakville, Ontario, Canada facility.
Costs included $0.3 million in termination benefits, $1.2 million
in fixed asset impairments and accelerated depreciation. There were
no restructuring expenses in the three months ended September 30,
2023. Manufacturing operations ceased at the Oakville, Ontario,
site in January 2023, with the successful relocation of the
Oakville products to U.S. facilities. On November 6, 2023, the
Company entered into an agreement for the purchase and sale of the
Oakville, Ontario site, at a total purchase price of $17.85 million
Canadian dollars, or approximately $13.0 million US dollars based
on the current exchange rate, subject to certain market
adjustments. Closing of the sale is expected to occur in the first
quarter of 2024.
Net income available to common shareholders for the third
quarter of 2023 was $9.5 million as compared to net loss of $(9.0)
million in the prior year period. Diluted earnings per share for
the three months ended September 30, 2023, was $0.45 compared to
diluted GAAP loss per share of $(0.55) in the prior year
period.
Adjusted non-GAAP diluted earnings per share was $1.27 in the
third quarter of 2023 compared to diluted earnings per share of
$0.58 in the third 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,
respectively.
Liquidity
As of September 30, 2023, the Company had $193.1 million in
unrestricted cash and cash equivalents, $178.8 million in net
accounts receivable and $294.8 million (face value) in outstanding
debt. The Company generated year-to-date cash flow from operations
of $74.2 million.
2023 Financial Guidance Upward Revisions
|
Revised Full Year 2023
Guidance |
|
Prior Full Year 2023
Guidance |
|
Prior YearActual |
|
Growth |
Net Revenue (total
Company) |
$468 million - $478 million |
|
$425 million - $445 million |
|
$316.4 million |
|
47.9% - 51.1% |
Cortrophin Gel Net
Revenue |
$100 million - $107 million |
|
$90 million - $100 million |
|
$41.7 million |
|
139.9% - 156.7% |
Adj. Non-GAAP Gross
Margin |
63.0% to 63.8% |
|
63% to 64.8% |
|
58.3% |
|
4.7 pts to 5.5 pts |
Adjusted Non-GAAP EBITDA |
$128 million - $133 million |
|
$115 million - $125 million |
|
$55.9 million |
|
129.1% - 138.1% |
Adjusted Non-GAAP Diluted
EPS |
$4.29 - $4.57 |
|
$3.62 - $4.11 |
|
$1.36 |
|
215.4% - 236.0% |
In addition, ANI currently anticipates between 19.2 million and
19.3 million shares outstanding for purpose of calculating EPS and
a U.S. GAAP effective tax rate of between approximately 9.0% to
13.0%. The Company will continue to tax affect adjustments for
computation of adjusted non-GAAP diluted earnings per share at a
tax rate of 24.0%.
Conference Call
As previously announced, ANI management will host its third
quarter 2023 conference call as follows:
Date Wednesday, November 8, 2023 Time 8:30 a.m. ETToll free
(U.S.) 800-445-7795
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 two
weeks by dialing 800-839-6737 and entering access code 4379958.
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 2023 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 (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, 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 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 (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.
ANI is not providing a reconciliation for the forward-looking
full year 2023 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 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: 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; 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 and
other regulatory agencies, including drug recalls; 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;
acceptance of our products at levels that will allow us to achieve
profitability; 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 finding 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, 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.
FINANCIAL TABLES FOLLOW
ANI Pharmaceuticals, Inc. and
SubsidiariesTable 1: US GAAP Statement of
Operations(unaudited, in thousands, except per share
amounts)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net Revenues |
$ |
131,829 |
|
|
$ |
83,821 |
|
|
$ |
355,162 |
|
|
$ |
222,153 |
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
Cost of sales (excluding depreciation and amortization) |
|
48,101 |
|
|
|
32,894 |
|
|
|
128,093 |
|
|
|
102,459 |
|
Research and development |
|
11,121 |
|
|
|
7,657 |
|
|
|
24,419 |
|
|
|
17,096 |
|
Selling, general, and administrative |
|
42,007 |
|
|
|
30,081 |
|
|
|
117,235 |
|
|
|
90,856 |
|
Depreciation and amortization |
|
15,207 |
|
|
|
14,167 |
|
|
|
44,597 |
|
|
|
42,488 |
|
Contingent consideration fair value adjustment |
|
(2,555 |
) |
|
|
2,476 |
|
|
|
(559 |
) |
|
|
2,134 |
|
Restructuring activities |
|
— |
|
|
|
1,541 |
|
|
|
1,132 |
|
|
|
4,111 |
|
Intangible asset impairment charge |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
112 |
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
113,881 |
|
|
|
88,816 |
|
|
|
314,917 |
|
|
|
259,256 |
|
|
|
|
|
|
|
|
|
Operating Income (Loss) |
|
17,948 |
|
|
|
(4,995 |
) |
|
|
40,245 |
|
|
|
(37,103 |
) |
|
|
|
|
|
|
|
|
Other Expense, net |
|
|
|
|
|
|
|
Interest expense, net |
|
(6,398 |
) |
|
|
(7,264 |
) |
|
|
(21,194 |
) |
|
|
(20,546 |
) |
Other (expense) income, net |
|
(39 |
) |
|
|
37 |
|
|
|
(126 |
) |
|
|
712 |
|
|
|
|
|
|
|
|
|
Income (Loss) Before Income Tax (Expense) Benefit |
|
11,511 |
|
|
|
(12,222 |
) |
|
|
18,925 |
|
|
|
(56,937 |
) |
|
|
|
|
|
|
|
|
Income tax (expense)
benefit |
|
(1,571 |
) |
|
|
3,622 |
|
|
|
(1,301 |
) |
|
|
13,284 |
|
|
|
|
|
|
|
|
|
Net Income (Loss) |
$ |
9,940 |
|
|
$ |
(8,600 |
) |
|
$ |
17,624 |
|
|
$ |
(43,653 |
) |
|
|
|
|
|
|
|
|
Dividends on Series A Convertible Preferred Stock |
|
(406 |
) |
|
|
(406 |
) |
|
|
(1,219 |
) |
|
|
(1,218 |
) |
|
|
|
|
|
|
|
|
Net Income (Loss) Available to Common Shareholders |
$ |
9,534 |
|
|
$ |
(9,006 |
) |
|
$ |
16,405 |
|
|
$ |
(44,871 |
) |
|
|
|
|
|
|
|
|
Basic and Diluted
Income (Loss) Per Share: |
|
|
|
|
|
|
|
Basic Income (Loss) Per
Share |
$ |
0.46 |
|
|
$ |
(0.55 |
) |
|
$ |
0.84 |
|
|
$ |
(2.76 |
) |
Diluted Income (Loss) Per
Share |
$ |
0.45 |
|
|
$ |
(0.55 |
) |
|
$ |
0.83 |
|
|
$ |
(2.76 |
) |
|
|
|
|
|
|
|
|
Basic Weighted-Average Shares
Outstanding |
|
18,883 |
|
|
|
16,303 |
|
|
|
17,663 |
|
|
|
16,238 |
|
Diluted Weighted-Average
Shares Outstanding |
|
19,125 |
|
|
|
16,303 |
|
|
|
17,823 |
|
|
|
16,238 |
|
ANI Pharmaceuticals, Inc. and
SubsidiariesTable 2: US GAAP Balance
Sheets(unaudited, in thousands)
|
September 30,2023 |
|
December 31,2022 |
Current Assets |
|
|
|
Cash and cash equivalents |
$ |
193,078 |
|
|
$ |
48,228 |
|
Current restricted cash |
|
— |
|
|
|
5,006 |
|
Accounts receivable, net |
|
178,842 |
|
|
|
165,438 |
|
Inventories |
|
106,590 |
|
|
|
105,355 |
|
Prepaid income taxes |
|
— |
|
|
|
3,827 |
|
Assets held for sale |
|
8,020 |
|
|
|
8,020 |
|
Prepaid expenses and other current assets |
|
10,690 |
|
|
|
8,387 |
|
Total Current Assets |
|
497,220 |
|
|
|
344,261 |
|
Non-current Assets |
|
|
|
Property and equipment, net |
|
44,189 |
|
|
|
43,246 |
|
Deferred tax assets, net of deferred tax liabilities and valuation
allowance |
|
84,389 |
|
|
|
81,363 |
|
Intangible assets, net |
|
219,828 |
|
|
|
251,635 |
|
Goodwill |
|
28,221 |
|
|
|
28,221 |
|
Derivatives and other non-current assets |
|
16,067 |
|
|
|
11,361 |
|
Total Assets |
$ |
889,914 |
|
|
$ |
760,087 |
|
|
|
|
|
Current Liabilities |
|
|
|
Income taxes payable |
$ |
594 |
|
|
$ |
— |
|
Current debt, net of deferred financing costs |
|
850 |
|
|
|
850 |
|
Accounts payable |
|
34,077 |
|
|
|
29,305 |
|
Accrued royalties |
|
11,975 |
|
|
|
9,307 |
|
Accrued compensation and related expenses |
|
15,328 |
|
|
|
10,312 |
|
Accrued government rebates |
|
10,923 |
|
|
|
10,872 |
|
Returned goods reserve |
|
31,438 |
|
|
|
33,399 |
|
Current contingent consideration |
|
23,939 |
|
|
|
— |
|
Accrued expenses and other |
|
5,228 |
|
|
|
5,394 |
|
Total Current Liabilities |
|
134,352 |
|
|
|
99,439 |
|
|
|
|
|
Non-current Liabilities |
|
|
|
Non-current debt, net of deferred financing costs and current
component |
|
285,032 |
|
|
|
285,669 |
|
Non-current contingent consideration |
|
10,560 |
|
|
|
35,058 |
|
Other non-current liabilities |
|
5,259 |
|
|
|
1,381 |
|
Total Liabilities |
$ |
435,203 |
|
|
$ |
421,547 |
|
|
|
|
|
Mezzanine
Equity |
|
|
|
Convertible Preferred Stock,
Series A |
|
24,850 |
|
|
|
24,850 |
|
|
|
|
|
Stockholders’ Equity |
|
|
|
Common Stock |
|
2 |
|
|
|
1 |
|
Treasury stock |
|
(9,850 |
) |
|
|
(5,094 |
) |
Additional paid-in capital |
|
506,513 |
|
|
|
403,901 |
|
Accumulated deficit |
|
(80,880 |
) |
|
|
(97,286 |
) |
Accumulated other comprehensive income, net of tax |
|
14,076 |
|
|
|
12,168 |
|
Total Stockholders’ Equity |
|
429,861 |
|
|
|
313,690 |
|
|
|
|
|
Total Liabilities, Mezzanine Equity, and Stockholders’ Equity |
$ |
889,914 |
|
|
$ |
760,087 |
|
ANI Pharmaceuticals, Inc. and
SubsidiariesTable 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 Ended September
30, |
|
|
|
|
Three Months Ended September 30, |
|
Three Months Ended September 30, |
|
Three Months Ended September 30, |
|
Three Months Ended September 30, |
|
|
2023 |
|
2022 |
|
|
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Net Income (Loss) |
|
$ |
9,940 |
|
|
$ |
(8,600 |
) |
|
|
As reported: |
|
$ |
131,829 |
|
|
$ |
83,821 |
|
|
$ |
48,101 |
|
|
$ |
32,894 |
|
|
$ |
42,007 |
|
|
$ |
30,081 |
|
|
$ |
11,121 |
|
|
$ |
7,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
6,398 |
|
|
|
7,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense (income), net |
|
|
39 |
|
|
|
(37 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
|
1,571 |
|
|
|
(3,622 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
15,207 |
|
|
|
14,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustment |
|
|
(2,555 |
) |
|
|
2,476 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring activities |
|
|
— |
|
|
|
1,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impact of Canada operations (1) |
|
|
275 |
|
|
|
840 |
|
|
|
Impact of Canada operations (1) |
|
|
— |
|
|
|
(969 |
) |
|
|
(128 |
) |
|
|
(681 |
) |
|
|
(147 |
) |
|
|
(1,052 |
) |
|
|
— |
|
|
|
(76 |
) |
Stock-based compensation |
|
|
5,444 |
|
|
|
3,869 |
|
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
(182 |
) |
|
|
(149 |
) |
|
|
(5,023 |
) |
|
|
(3,524 |
) |
|
|
(239 |
) |
|
|
(196 |
) |
Excess of fair value over cost of acquired inventory |
|
|
— |
|
|
|
443 |
|
|
|
Excess of fair value over cost of acquired inventory |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(443 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Novitium transaction expenses |
|
|
165 |
|
|
|
59 |
|
|
|
Novitium transaction expenses |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(165 |
) |
|
|
(59 |
) |
|
|
— |
|
|
|
— |
|
Adjusted non-GAAP EBITDA |
|
$ |
36,484 |
|
|
$ |
18,400 |
|
|
|
As adjusted: |
|
$ |
131,829 |
|
|
$ |
82,852 |
|
|
$ |
47,791 |
|
|
$ |
31,621 |
|
|
$ |
36,672 |
|
|
$ |
25,446 |
|
|
$ |
10,882 |
|
|
$ |
7,385 |
|
(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, which
was completed as of March 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 |
|
|
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, |
|
|
2023 |
|
2022 |
|
|
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss) |
|
$ |
17,624 |
|
|
$ |
(43,653 |
) |
|
|
As reported: |
|
$ |
355,162 |
|
|
$ |
222,153 |
|
|
$ |
128,093 |
|
|
$ |
102,459 |
|
|
$ |
117,235 |
|
|
$ |
90,856 |
|
|
$ |
24,419 |
|
|
$ |
17,096 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
21,194 |
|
|
|
20,546 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense (income), net (1) |
|
|
126 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
|
1,301 |
|
|
|
(13,284 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
44,597 |
|
|
|
42,488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration fair value adjustment |
|
|
(559 |
) |
|
|
2,134 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset impairment charge |
|
|
— |
|
|
|
112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring activities |
|
|
1,132 |
|
|
|
4,111 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impact of Canada operations(2) |
|
|
2,414 |
|
|
|
2,661 |
|
|
|
Impact of Canada operations(2) |
|
|
(565 |
) |
|
|
(2,014 |
) |
|
|
(1,833 |
) |
|
|
(1,930 |
) |
|
|
(1,073 |
) |
|
|
(2,598 |
) |
|
|
(73 |
) |
|
|
(147 |
) |
Stock-based compensation |
|
|
15,031 |
|
|
|
10,862 |
|
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
(521 |
) |
|
|
(442 |
) |
|
|
(13,839 |
) |
|
|
(9,858 |
) |
|
|
(671 |
) |
|
|
(562 |
) |
Excess of fair value over cost of acquired inventory |
|
|
— |
|
|
|
5,246 |
|
|
|
Excess of fair value over cost of acquired inventory |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,246 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Novitium transaction expenses |
|
|
757 |
|
|
|
1,276 |
|
|
|
Novitium transaction expenses |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(757 |
) |
|
|
(1,276 |
) |
|
|
— |
|
|
|
— |
|
Adjusted non-GAAP EBITDA |
|
$ |
103,617 |
|
|
$ |
32,537 |
|
|
|
As adjusted: |
|
$ |
354,597 |
|
|
$ |
220,139 |
|
|
$ |
125,739 |
|
|
$ |
94,841 |
|
|
$ |
101,566 |
|
|
$ |
77,124 |
|
|
$ |
23,675 |
|
|
$ |
16,387 |
|
(1) Adjustment to Other expense (income), net
excludes $750 thousand of income related to the sale of an ANDA
during the nine months ended September 30, 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, which was completed as of March 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
SubsidiariesTable 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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss) Available to
Common Shareholders |
$ |
9,534 |
|
|
$ |
(9,006 |
) |
|
$ |
16,405 |
|
|
$ |
(44,871 |
) |
|
|
|
|
|
|
|
|
Add/(Subtract): |
|
|
|
|
|
|
|
Non-cash interest expense |
|
856 |
|
|
|
963 |
|
|
|
2,530 |
|
|
|
2,883 |
|
Depreciation and amortization |
|
15,207 |
|
|
|
14,167 |
|
|
|
44,597 |
|
|
|
42,488 |
|
Contingent consideration fair value adjustment |
|
(2,555 |
) |
|
|
2,476 |
|
|
|
(559 |
) |
|
|
2,134 |
|
Restructuring activities |
|
— |
|
|
|
1,541 |
|
|
|
1,132 |
|
|
|
4,111 |
|
Intangible asset impairment charge |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
112 |
|
Impact of Canada operations(1) |
|
275 |
|
|
|
840 |
|
|
|
2,414 |
|
|
|
2,661 |
|
Stock-based compensation |
|
5,444 |
|
|
|
3,869 |
|
|
|
15,031 |
|
|
|
10,862 |
|
Excess of fair value over cost of acquired inventory |
|
— |
|
|
|
443 |
|
|
|
— |
|
|
|
5,246 |
|
Novitium transaction expenses |
|
165 |
|
|
|
59 |
|
|
|
757 |
|
|
|
1,276 |
|
Less: |
|
|
|
|
|
|
|
Estimated tax impact of adjustments (calc. at 24%) |
|
(4,654 |
) |
|
|
(5,846 |
) |
|
|
(15,816 |
) |
|
|
(17,226 |
) |
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net Income
Available to Common Shareholders (2) |
$ |
24,272 |
|
|
$ |
9,506 |
|
|
$ |
66,491 |
|
|
$ |
9,676 |
|
Diluted Weighted-Average |
|
|
|
|
|
|
|
Shares Outstanding |
|
19,125 |
|
|
|
16,303 |
|
|
|
17,823 |
|
|
|
16,238 |
|
Adjusted Diluted
Weighted-Average |
|
|
|
|
|
|
|
Shares Outstanding |
|
19,125 |
|
|
|
16,317 |
|
|
|
17,823 |
|
|
|
16,252 |
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP |
|
|
|
|
|
|
|
Diluted Earnings per Share |
$ |
1.27 |
|
|
$ |
0.58 |
|
|
$ |
3.73 |
|
|
$ |
0.60 |
|
(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 September 30, 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.
ANI Pharmaceuticals (NASDAQ:ANIP)
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ANI Pharmaceuticals (NASDAQ:ANIP)
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