BAUDETTE, Minn., Feb. 27, 2020 /PRNewswire/ --
For the full year ended December 31,
2019:
- Record net revenues of $206.5
million, an increase of 2.5% versus 2018
- GAAP net income of $6.1
million and diluted GAAP earnings per share of $0.50
- Adjusted non-GAAP EBITDA of $83.2
million
- Adjusted non-GAAP diluted earnings per share of $5.06
For the fourth quarter 2019:
- Net revenues of $48.0 million
versus $57.1 million in 2018
- GAAP net loss of $4.8 million
and diluted GAAP loss per share of $0.41
- Adjusted non-GAAP EBITDA of $17.4
million
- Adjusted non-GAAP diluted earnings per share of $1.08
Guidance for 2020:
- Net revenues of $213 million
to $223 million
- Adjusted non-GAAP EBITDA of $80
million to $86
million
- Adjusted non-GAAP diluted earnings per share of $4.46 to $4.86
ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP)
today reported its financial results for the three and twelve
months ended December 31, 2019 and
provided its 2020 financial guidance. The Company will host its
earnings conference call this morning, February 27, 2020, at 10:30 AM ET. Investors and other interested
parties can join the call by dialing (866) 776-8875. The conference
ID is 4783883.
Financial Summary
|
(in thousands,
except per share data)
|
|
Q4
2019
|
|
Q4
2018
|
|
2019(a)
|
|
2018(a)
|
|
Net
revenues
|
|
$ 47,966
|
|
$ 57,122
|
|
$ 206,547
|
|
$ 201,576
|
|
Net
(loss)/income
|
|
$
(4,835)
|
|
$
5,430
|
|
$
6,094
|
|
$
15,494
|
|
GAAP
(loss)/earnings per diluted share
|
|
$
(0.41)
|
|
$
0.46
|
|
$
0.50
|
|
$
1.30
|
|
Adjusted non-GAAP
EBITDA(b)
|
|
$ 17,383
|
|
$ 22,184
|
|
$
83,158
|
|
$
84,401
|
|
Adjusted non-GAAP
diluted earnings per share(c)
|
|
$
1.08
|
|
$
1.32
|
|
$
5.06
|
|
$
5.07
|
|
|
(a) See ANI's Form 10-K filed
February 27, 2020 for discussion of year-to-date
results.
|
|
(b) See Table 3 for US GAAP
reconciliation.
|
|
(c) See Table 4 for US GAAP
reconciliation.
|
Arthur S. Przybyl, President and
CEO, stated,
"ANI generated record net revenues and non-GAAP gross profit in
2019 while continuing to diversify its commercial product offering
and pipeline opportunities. While revenues and non-GAAP gross
profit for three of our important generic products were negatively
impacted in recent periods, overall our business remains resilient,
and we look forward to leveraging important recent launches such as
Vancomycin Oral Solution and Bretylium Tosylate Injection as well
as the recently acquired Amerigen portfolio in 2020. During
2019, we launched several new products, entered into collaborative
arrangements with strategic partners and acquired both previously
approved and development stage products we plan to launch in the
future. We have utilized strong operating cash flows for asset
acquisitions and investment into our portfolio of pipeline products
and expect to continue to do so in the future.
During the fourth quarter, we successfully completed our fourth
commercial scale batch of both Corticotropin API and the
Cortrophin® Gel drug product, and importantly, remain on track to
submit our supplemental NDA filing in March
2020."
2020 Financial Guidance
For the twelve months ending December 31,
2020, ANI is providing guidance on net revenue, adjusted
non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share.
The following table summarizes 2020 guidance as compared to 2019
actual results:
|
($ in millions
except per share data)
|
2019
|
|
2020 Guidance
Range
|
|
% Change from
Prior Year
|
|
Actual
|
|
Low
|
Mid
|
High
|
|
Low
|
Mid
|
High
|
|
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
$
206.5
|
|
$
213.0
|
$
218.0
|
$
223.0
|
|
3%
|
6%
|
8%
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP
EBITDA
|
$
83.2
|
|
$
80.0
|
$
83.0
|
$
86.0
|
|
-4%
|
0%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP
diluted earnings per share
|
$
5.06
|
|
$
4.46
|
$
4.66
|
$
4.86
|
|
-12%
|
-8%
|
-4%
|
In addition, we expect that adjusted non-GAAP gross margin,
defined as the result of Net Revenues less Cost of Sales (excluding
depreciation and amortization) as a percentage of Net Revenues,
will decline from approximately 71% in 2019 to the mid 60% range in
2020, driven by the impact of negative price and product mix. Year
over year changes of our Adjusted non-GAAP diluted earnings per
share metric differ from our Adjusted non-GAAP EBITDA metric due to
a projected increase in cash interest expense resulting from the
refinancing of our convertible debt to bank debt.
ANI's full year 2020 financial guidance reflects management's
current assumptions regarding customer relationships, product
pricing, prescription trends, competition, inventory levels, cost
of sales, operating costs, timing of research and development
spend, taxes, and the anticipated timing of future product launches
and other key events.
Cortrophin® Gel Re-commercialization Update
|
Product
|
Required
Filing
|
Expected Filing
Date
|
Total Annual
Market(d)
|
|
Cortrophin®
Gel
|
sNDA
|
March 2020
|
$1.0
billion
|
|
|
(d) Based on data from
IQVIA
|
We continue to successfully progress our Cortrophin®
Gel re-commercialization program. Significant accomplishments since
the third quarter 2019 press release (dated November 6, 2019) include:
- ANI successfully completed API process validation by completing
the fourth commercial scale batch of Corticotropin API. ANI
also completed manufacturing for a fifth commercial scale batch of
Corticotropin API. All five commercial scale batches were
analytically consistent with each other and met all API release
specifications. ANI expects to have 6 months stability on all
API registration batches prior to the sNDA filing and by the end of
first quarter 2020.
- ANI successfully completed drug product process validation in
the fourth quarter of 2019. ANI also completed manufacturing of a
fourth commercial scale batch of Cortrophin® Gel. This
batch was analytically consistent with previously manufactured
batches and met all drug product release specifications. ANI had
already completed manufacturing for three commercial scale
registration stability batches of Cortrophin® Gel and
expects to have 6 months stability on each prior to the sNDA filing
and by the end of first quarter 2020.
ANI is on track to file the sNDA as planned by March 2020.
For further details, please see ANI's Cortrophin® Gel
Re-commercialization Milestone Update in Table 5.
Fourth Quarter Results
|
Net
Revenues
(in
thousands)
|
|
Three Months
Ended
December 31,
|
|
|
|
|
|
|
|
2019
|
|
2018
|
|
Change
|
|
%
Change
|
|
Generic
pharmaceutical products
|
|
$
|
29,121
|
|
$
|
33,735
|
|
$
|
(4,614)
|
|
(14)%
|
|
Branded
pharmaceutical products
|
|
|
15,624
|
|
|
18,840
|
|
|
(3,216)
|
|
(17)%
|
|
Contract
manufacturing
|
|
|
2,640
|
|
|
3,669
|
|
|
(1,029)
|
|
(28)%
|
|
Royalty and other
income
|
|
|
581
|
|
|
878
|
|
|
(297)
|
|
(34)%
|
|
Total net
revenues
|
|
$
|
47,966
|
|
$
|
57,122
|
|
$
|
(9,156)
|
|
(16)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic Pharmaceutical Products
Fourth Quarter Net Revenues - Results and Update
Net revenues from sales of generic pharmaceuticals decreased 14%
to $29.1 million from $33.7 million in the prior period, primarily due
to decreases in sales of Esterified Estrogen with
Methlytestosterone ("EEMT"), Erythromycin Ethylsuccinate ("EES"),
Propafenone, and Fenofibrate. These decreases were tempered by the
September 2019 launch of Vancomycin
HCl for Oral Solution as well as increased unit sales of Vancomycin
tablets.
Branded Pharmaceutical Products
Fourth Quarter Net Revenues - Results and Update
Net revenues from sales of branded pharmaceuticals decreased 17%
to $15.6 million from $18.8 million in the prior period, primarily due
to decrease in sales of Inderal® LA, Atacand® and Atacand HCT®.
These decreases were tempered by increased sales of InnoPran
XL®.
Contract Manufacturing
Fourth Quarter Net Revenues - Results and Update
Contract manufacturing revenues decreased 28% to $2.6 million from $3.7
million in the prior year period, due to the timing and
volume of orders from contract manufacturing customers in the
period.
Royalty and Other
Fourth Quarter Net Revenues - Result and Update
Royalty and Other decreased 34% to $0.6 million from $0.9 million, primarily due to the timing
and volume of product development and laboratory services revenue
earned by ANI Canada.
Operating Expenses
Operating expenses increased to $52.6
million for the three months ended December 31, 2019, from $45.7 million in the prior year period. The
increase was primarily due to the following:
- $6.5 million in the build of
Cortrophin pre-launch commercial inventories (which are expensed
for US GAAP); there were no such activities in 2018,
- $1.2 million increase in research
and development expense, primarily due to Q4 2019 development-based
milestone payments earned by collaborative partners, and
- $0.9 million increase in
depreciation and amortization expense, primarily due to additional
amortization expense associated with a March
2019 asset acquisition and a January
2019 royalty buyout payment related to a prior period asset
acquisition.
These increases were partially offset by a $2.3 million decrease in cost of sales as a
result of the previously mentioned royalty buyout in January 2019 and a decrease in sales over the
comparable periods, tempered by Q4 2019 inventory reserve charges
of $4.6 million primarily related to
the Company's exit from the Methylphenidate Extended Release
market.
Cost of sales as a percentage of net revenues increased
to 37% during the three months ended December 31, 2019, from 35% during same period in
2018. The increase was primarily due to the inventory reserve
charges recognized in the fourth quarter 2019 and negative price,
which were tempered by reductions related to the 2019 royalty
buyout.
Net Loss and Diluted Loss per Share
Net loss was $4.8 million for the
three months ended December 31, 2019,
as compared to net income of $5.4
million in the prior year period. The net loss was driven by
the previously mentioned $6.5 million
build of Cortrophin pre-launch commercial inventories and
$4.6 million of inventory reserve
charges. The effective consolidated tax benefit rate for the
three months ended December 31, 2019
was 37%.
Diluted loss per share for the three months ended December 31, 2019 was $0.41, based on 11,886 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.46 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $1.08, as compared to adjusted non-GAAP
diluted earnings per share of $1.32
in the prior year period. For a reconciliation of adjusted non-GAAP
diluted earnings per share to the most directly comparable GAAP
financial measure, please see Table 4.
ANI Product Development Pipeline
ANI's pipeline consists of 118 products, addressing a total
annual market size of $7.0 billion,
based on data from IQVIA. Of these, ANI expects that at least 52
can be commercialized based on either CBE-30s or prior approval
supplements filed with the FDA.
Non-GAAP Financial Measures
The Company's fiscal 2019 guidance for adjusted non-GAAP EBITDA
and adjusted non-GAAP diluted earnings per share is not reconciled
to the most comparable GAAP measure. This is due to the inherent
difficulty of forecasting the timing or amount of items that would
be included in a reconciliation to the most directly comparable
forward-looking GAAP financial measures. Because a reconciliation
is not available without unreasonable effort, it is not included in
this release.
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 income/(loss),
excluding tax expense, interest expense, depreciation,
amortization, the excess of fair value over cost of acquired
inventory, stock-based compensation expense, expense from acquired
in-process research and development, gains, losses, and expenses
related to the repurchase of convertible debt, expenses related to
debt financing, transaction and integration expenses, non-cash
impairment charges, Cortrophin pre-launch charges, other income /
expense and certain other items, including expensed milestone
payments and inventory reserve charges, 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 in Table 3.
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 purchase accounting adjustments, non-cash
stock-based compensation, non-cash interest expense, depreciation
and amortization, non-cash impairment charges, Cortrophin
pre-launch charges and certain other items, including expensed
milestone payments and inventory reserve charges, 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 income/(loss),
plus the excess of fair value over cost of acquired inventory,
stock-based compensation expense, transaction and integration
expenses, gains, losses, and expenses related to the repurchase of
convertible debt, expenses related to debt financing, non-cash
interest expense, depreciation and amortization expense, expense
from acquired in-process research and development, non-cash
impairment charges, Cortrophin pre-launch charges and certain other
items, including expensed milestone payments and inventory reserve
charges, 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 in Table 4.
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 purchase accounting adjustments,
non-cash stock-based compensation, non-cash interest expense,
depreciation and amortization, non-cash impairment charges,
Cortrophin pre-launch charges and certain other items, including
expensed milestone payments and inventory reserve charges, 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, as
adjusted for the dilutive effect of the convertible debt notes (in
2019), when applicable. 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 or loss 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 in Table 4.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing high quality branded and generic
prescription pharmaceuticals. The Company's targeted areas of
product development currently include controlled substances,
oncolytics (anti-cancers), hormones and steroids, and complex
formulations involving extended release and combination products.
For more information, please visit the Company's 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, statements about price increases, the Company's future
operations, products, financial position, operating results and
prospects, the Company's pipeline or potential markets therefor,
and other statements that are not historical in nature,
particularly those that utilize terminology such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may face with
respect to importing raw materials; increased competition;
acquisitions; contract manufacturing arrangements; delays or
failure in obtaining product approvals from the U.S. Food and Drug
Administration; general business and economic conditions; market
trends; regulatory environment; products development; regulatory
and other approvals; and marketing.
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,
including its most recent Annual Report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. 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.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
|
Table 1: US GAAP
Statement of Operations
|
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$47,966
|
|
$57,122
|
|
$206,547
|
|
$201,576
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
Cost of
sales (excl. depreciation
|
|
|
|
|
|
|
|
|
|
and
amortization)
|
|
17,795
|
|
20,133
|
|
63,154
|
|
73,024
|
|
Research and
development
|
|
4,678
|
|
3,482
|
|
19,806
|
|
15,388
|
|
Selling, general, and
administrative
|
|
14,014
|
|
13,376
|
|
55,843
|
|
44,063
|
|
Depreciation and
amortization
|
|
9,564
|
|
8,686
|
|
44,612
|
|
33,742
|
|
Cortrophin pre-launch
charges
|
|
6,511
|
|
-
|
|
6,706
|
|
-
|
|
Intangible asset
impairment charge
|
|
75
|
|
-
|
|
75
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
52,637
|
|
45,677
|
|
190,196
|
|
166,217
|
|
|
|
|
|
|
|
|
|
|
Operating
(Loss)/Income
|
|
(4,671)
|
|
11,445
|
|
16,351
|
|
35,359
|
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
(2,870)
|
|
(3,626)
|
|
(12,966)
|
|
(14,758)
|
|
Other
expense, net
|
|
(111)
|
|
(479)
|
|
(228)
|
|
(550)
|
|
|
|
|
|
|
|
|
|
|
(Loss)/Income Before
Benefit/(Provision) for Income Taxes
|
|
(7,652)
|
|
7,340
|
|
3,157
|
|
20,051
|
|
|
|
|
|
|
|
|
|
|
Benefit/(Provision)
for Income Taxes
|
|
2,817
|
|
(1,910)
|
|
2,937
|
|
(4,557)
|
|
|
|
|
|
|
|
|
|
|
Net
(Loss)/Income
|
|
$ (4,835)
|
|
$
5,430
|
|
$
6,094
|
|
$
15,494
|
|
|
|
|
|
|
|
|
|
|
(Loss)/Earnings
Per Share
|
|
|
|
|
|
|
|
|
|
Basic (Loss)/Earnings
Per Share
|
|
$
(0.41)
|
|
$
0.46
|
|
$
0.51
|
|
$
1.31
|
|
Diluted
(Loss)/Earnings Per Share
|
|
$
(0.41)
|
|
$
0.46
|
|
$
0.50
|
|
$
1.30
|
|
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,886
|
|
11,730
|
|
11,841
|
|
11,677
|
|
Diluted
Weighted-Average Shares Outstanding
|
|
11,886
|
|
11,785
|
|
12,040
|
|
11,772
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
|
Table 2: US GAAP
Balance Sheets
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
December 31,
2019
|
|
December 31,
2018
|
|
Current
Assets
|
|
|
|
|
Cash and cash equivalents
|
$
62,332
|
|
$
43,008
|
|
Accounts receivable, net
|
72,129
|
|
64,842
|
|
Inventories, net
|
48,163
|
|
40,503
|
|
Prepaid income taxes, net
|
1,076
|
|
-
|
|
Prepaid expenses and other current assets
|
3,995
|
|
4,524
|
|
|
|
|
|
Total
Current Assets
|
187,695
|
|
152,877
|
|
|
|
|
|
Property and
equipment, net
|
40,551
|
|
38,090
|
|
Restricted
cash
|
5,029
|
|
5,021
|
|
Deferred tax assets,
net of deferred tax liabilities and valuation allowance
|
38,326
|
|
27,964
|
|
Intangible assets,
net
|
180,388
|
|
201,604
|
|
Goodwill
|
3,580
|
|
3,580
|
|
Other non-current
assets
|
1,220
|
|
1,468
|
|
|
|
|
|
Total
Assets
|
$
456,789
|
|
$
430,604
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
Current component of Term Loan and DDTL, net of deferred financing
costs
|
$
9,941
|
|
$
3,256
|
|
Convertible Notes, net of discount and deferred financing
costs
|
-
|
|
112,463
|
|
Accounts payable
|
14,606
|
|
8,884
|
|
Accrued expenses and other
|
2,362
|
|
1,707
|
|
Accrued royalties
|
5,084
|
|
8,456
|
|
Accrued compensation and related expenses
|
3,736
|
|
3,524
|
|
Current income taxes payable, net
|
-
|
|
5,022
|
|
Accrued government rebates
|
8,901
|
|
8,974
|
|
Returned goods reserve
|
16,595
|
|
12,552
|
|
Deferred revenue
|
451
|
|
711
|
|
|
|
|
|
Total
Current Liabilities
|
61,676
|
|
165,549
|
|
|
|
|
|
Term Loan and DDTL,
net of deferred financing costs and current borrowing
component
|
175,808
|
|
67,296
|
|
Other non-current
long-term liabilities
|
6,514
|
|
496
|
|
|
|
|
|
Total
Liabilities
|
243,998
|
|
233,341
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
Common
stock
|
1
|
|
1
|
|
Treasury
stock
|
(723)
|
|
(659)
|
|
Additional paid-in
capital
|
200,800
|
|
186,812
|
|
Retained
earnings
|
17,584
|
|
11,488
|
|
Accumulated other
comprehensive loss, net of tax
|
(4,871)
|
|
(379)
|
|
|
|
|
|
Total
Stockholders' Equity
|
212,791
|
|
197,263
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
$
456,789
|
|
$
430,604
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
|
Table 3: Adjusted
non-GAAP EBITDA Calculation and US GAAP to Non-GAAP
Reconciliation
|
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Net
(Loss)/Income
|
|
$ (4,835)
|
|
$
5,430
|
|
$
6,094
|
|
$15,494
|
|
|
|
|
|
|
|
|
|
|
Add/(Subtract):
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
|
2,870
|
|
3,626
|
|
12,966
|
|
14,758
|
|
Other
(income)/expense, net, less loss on and expense
|
|
|
|
|
|
|
|
|
|
on repurchase
of convertible debt
|
|
111
|
|
(90)
|
|
228
|
|
(19)
|
|
(Benefit)/provision
for income taxes
|
|
(2,817)
|
|
1,910
|
|
(2,937)
|
|
4,557
|
|
Depreciation and
amortization
|
|
9,564
|
|
8,686
|
|
44,612
|
|
33,742
|
|
Cortrophin pre-launch
charges
|
|
6,511
|
|
-
|
|
6,706
|
|
-
|
|
Stock-based
compensation
|
|
2,444
|
|
1,828
|
|
9,217
|
|
6,782
|
|
Acquired IPR&D
expense
|
|
-
|
|
-
|
|
2,324
|
|
1,335
|
|
Excess of fair value
over cost of acquired inventory
|
|
-
|
|
-
|
|
-
|
|
5,689
|
|
Loss on and expense
on repurchase of convertible debt
|
|
|
|
|
|
|
|
|
|
and
expense on debt refinancing
|
|
-
|
|
691
|
|
-
|
|
691
|
|
Transaction and
integration expenses
|
|
-
|
|
103
|
|
84
|
|
1,372
|
|
Intangible asset
impairment charge
|
|
75
|
|
-
|
|
75
|
|
-
|
|
Expensed FDA approval
milestone payment
|
|
-
|
|
-
|
|
329
|
|
-
|
|
Inventory reserve
charges related to market exits
|
|
3,460
|
|
|
|
3,460
|
|
-
|
|
Adjusted non-GAAP
EBITDA
|
|
$17,383
|
|
$22,184
|
|
$83,158
|
|
$84,401
|
|
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,
|
|
Year Ended
December 31,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
Net
(Loss)/Income
|
|
$ (4,835)
|
|
$
5,430
|
|
$
6,094
|
|
$15,494
|
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
|
Non-cash interest expense
|
|
1,308
|
|
1,903
|
|
6,833
|
|
7,741
|
|
Depreciation and amortization expense
|
|
9,564
|
|
8,686
|
|
44,612
|
|
33,742
|
|
Cortrophin pre-launch charges
|
|
6,511
|
|
-
|
|
6,706
|
|
-
|
|
Expensed FDA approval milestone payment
|
|
-
|
|
-
|
|
329
|
|
-
|
|
Acquired IPR&D expense
|
|
-
|
|
-
|
|
2,324
|
|
1,335
|
|
Stock-based compensation
|
|
2,444
|
|
1,828
|
|
9,217
|
|
6,782
|
|
Inventory reserve charges related to market exits
|
|
3,460
|
|
-
|
|
3,460
|
|
-
|
|
Intangible asset impairment
|
|
75
|
|
-
|
|
75
|
|
-
|
|
Excess of fair value over cost of acquired inventory
|
|
-
|
|
-
|
|
-
|
|
5,689
|
|
Loss on and expense on repurchase of convertible
debt
|
|
|
|
|
|
|
|
|
|
and expense on
debt refinancing
|
|
-
|
|
691
|
|
-
|
|
691
|
|
Transaction and integration expenses
|
|
-
|
|
103
|
|
84
|
|
1,372
|
|
Less
|
|
|
|
|
|
|
|
|
|
Tax
impact of adjustments
|
|
(5,607)
|
|
(3,039)
|
|
(17,674)
|
|
(13,191)
|
|
Discrete tax
benefit related to ANI Canada transfer pricing agreement
|
-
|
|
-
|
|
(1,653)
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$12,920
|
|
$15,602
|
|
$60,407
|
|
$59,655
|
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
|
|
|
|
Shares
Outstanding
|
|
11,886
|
|
11,785
|
|
12,040
|
|
11,772
|
|
Less: dilutive effect
of Notes
|
|
-
|
|
-
|
|
(96)
|
|
-
|
|
Adjusted Diluted
Weighted-Average
|
|
|
|
|
|
|
|
|
|
Shares
Outstanding
|
|
11,980
|
|
11,785
|
|
11,944
|
|
11,772
|
|
|
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
|
|
|
|
Diluted Earnings per Share
|
|
$
1.08
|
|
$
1.32
|
|
$
5.06
|
|
$
5.07
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
|
Table 5:
Cortrophin® Gel Re-Commercialization Milestone
Update
|
|
|
|
|
|
|
|
|
|
Objective
|
Duration
|
Steps /
Details
|
Status
|
|
Manufacture
Commercial Scale Batches of Corticotropin API
|
2-3 months per
batch
|
• Scale-up
manufacturing process 5x to projected commercial scale
|
Complete
|
|
• Finalize API
manufacturing process & initiate PV / registration
batches
|
Complete
|
|
• Method development
for API characterization methods
|
Complete
|
|
• Method validation
for API release / stability methods
|
Complete
|
|
• Perform viral
clearance studies and validation
|
Complete
|
|
Manufacture
Commercial Scale Batches of Cortrophin® Gel Drug
Product
|
1 month per
batch
|
|
|
|
• Finalize drug
product manufacturing process
|
Complete
|
|
• Initiate process
validation
|
Complete
|
|
• Method validation
for API release / stability methods
|
Complete
|
|
• Manufacture three
API and three drug product registration batches
|
Complete
|
|
|
|
|
|
Registration
Stability for sNDA
|
6 months
|
• Initiate
registration stability studies
|
Complete
|
|
• Demonstrate 6
months accelerated and real-time stability prior to sNDA
submission
|
On Track
|
|
sNDA
Submission
|
4 months
|
• Target date: March
2020
|
On Track
|
|
• sNDA filing four
month PDUFA date: July 2020
|
|
View original
content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-full-year-and-fourth-quarter-2019-results-provides-2020-guidance-and-remains-on-track-to-submit-cortrophin-gel-snda-to-fda-in-march-2020-301012068.html
SOURCE ANI Pharmaceuticals, Inc.