BAUDETTE, Minn., Nov. 2, 2017 /PRNewswire/ --
For the third quarter 2017:
- Net revenues of $48.2 million,
an increase of 25% as compared to the same period in 2016
- GAAP net income of $4.7
million and diluted GAAP earnings per share of $0.40
- Adjusted non-GAAP EBITDA of $20.7
million
- Adjusted non-GAAP diluted earnings per share of $1.11
ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today
reported its financial results for the three and nine months ended
September 30, 2017, and reaffirmed
its 2017 financial guidance. The Company will host its earnings
conference call this morning, November 2,
2017, at 10:30 AM ET.
Investors and other interested parties can join the call by dialing
(866) 776-8875. The conference ID is 95990267.
Financial Summary
(in thousands,
except per share data)
|
|
Q3
2017
|
|
Q3
2016
|
|
YTD
2017
|
|
YTD
2016
|
Net
revenues
|
|
$ 48,164
|
|
$ 38,525
|
|
$ 129,556
|
|
$ 90,417
|
Net
income
|
|
$
4,720
|
|
$
2,543
|
|
$
8,553
|
|
$
5,014
|
GAAP earnings per
diluted share
|
|
$
0.40
|
|
$
0.22
|
|
$
0.73
|
|
$
0.43
|
Adjusted non-GAAP
EBITDA(a)
|
|
$ 20,662
|
|
$ 16,354
|
|
$ 54,503
|
|
$ 43,178
|
Adjusted non-GAAP
diluted earnings per share(b)
|
|
$
1.11
|
|
$
0.77
|
|
$
2.83
|
|
$
2.05
|
|
(a) See
Table 3 for US GAAP reconciliation.
|
(b) See
Table 4 for US GAAP reconciliation.
|
Arthur S. Przybyl, President and
CEO, stated,
"This was a record quarter for ANI, with revenues, adjusted
non-GAAP EBITDA, and adjusted non-GAAP diluted earnings per share
increasing 25%, 26%, and 44%, respectively, as compared to the
prior year. These increases are the direct result of the launches
of InnoPran XL® and Inderal® XL in February
2017 and the continued impact of generic products launched
in 2016 and 2017.
ANI continues to grow its branded product revenue base, an
important strategic objective for the Company. To that end, we
continue to advance the development and subsequent
commercialization of two branded products, Vancocin® oral solution
and Cortrophin® gel. Both of these drugs are FDA approved products,
but will require ANI to file a prior approval supplement with the
FDA prior to commercialization."
ANI Narrows Guidance for the Full Year 2017
ANI estimates are based on projected results for the twelve
months ending December 31, 2017 and
reflect management's current beliefs about product pricing,
prescription trends, inventory levels, cost of sales, operating
costs, timing of research and development spend, taxes, and the
anticipated timing of future product launches and events. ANI is
updating its full year 2017 guidance range to narrow its previously
published guidance for net revenues and adjusted non-GAAP EBITDA.
In conjunction with this change, ANI is narrowing and making a
modest upward revision in its projected full year adjusted non-GAAP
diluted earnings per share and improvement in its cost of sales as
a percentage of revenues (excluding the impact of inventory
step-up). The changes to guidance reflect better than
previously-forecast product mix and gross profit pull through on
net revenues.
(in millions,
except per share data and percentages)
|
|
Previous
Guidance
|
|
Revised
Guidance
|
Net
revenues
|
|
$181 to
$190
|
|
$181 to
$183
|
Cost of sales as a
percent of revenues (excluding impact of inventory
step-up)
|
|
42% to 44%
|
|
39% to 41%
|
Adjusted non-GAAP
EBITDA
|
|
$73.1 to
$77.2
|
|
$74.0 to
$76.3
|
Adjusted non-GAAP
diluted earnings per share
|
|
$3.58 to
$3.94
|
|
$3.83 to
$4.00
|
Cortrophin® Gel Re-commercialization Update
In the third quarter of 2017, ANI executed a long-term
commercial supply agreement with its Cortrophin® gel fill/finish
contract manufacturer ("CMO"), specializing in aseptic parenteral
manufacturing using mobile isolator technology. ANI plans to
initiate manufacturing Cortrophin® gel development batches in the
fourth quarter of 2017, using the active pharmaceutical ingredient
("API") from its recently manufactured intermediate scale
batches. Combined with its current relationships with raw
material suppliers for porcine pituitary glands and purified
corticotropin powder (the API), ANI has now reached a very
important milestone by securing its Cortrophin® gel supply
chain.
ANI has continued to advance the manufacture of corticotropin
API, successfully manufacturing its first intermediate scale batch
of API. This intermediate scale batch of corticotropin API was
five times larger than its initial successful small-scale API batch
and resulted in proportional increases in both yield and
potency. ANI initiated manufacturing a second intermediate
scale batch in the third quarter and expects to complete
manufacturing of intermediate scale API batches two and three by
the end of this year. ANI expects to be able to demonstrate
lot-to-lot consistency as it continues to build its comprehensive
characterization package. ANI plans to initiate commercial
scale API manufacturing in early 2018.
ANI has continued to modernize the corticotropin
characterization package by developing and implementing new and
current analytical technologies that were not part of the original
Cortrophin® gel NDA. These molecular biology techniques have
been successfully developed to analyze both corticotropin as well
as other related peptides. ANI has also developed a variety of
methods to characterize in-process samples after completion of
critical stages of corticotropin API manufacturing. These
methods are being used to better control the API manufacturing
process and identify its critical process parameters. These
methods are being utilized throughout the API manufacturing process
as a means of establishing lot-to-lot consistency and process
control and demonstrating comparability to historically
manufactured commercial lots of API.
ANI intends to request a meeting with the FDA in the fourth
quarter of 2017 to present its Regulatory Filing Plan.
For further details, please see ANI's Cortrophin® Gel
Re-commercialization Milestone Update in Table 5.
Vancocin® Oral Solution Update
ANI is currently advancing a commercialization effort for
Vancocin® oral solution. Following completion of ongoing
formulation and manufacturing optimization, ANI intends to file a
prior approval supplement ("PAS") in the second half of 2018. This
product will be manufactured at ANI's site in Baudette, MN. The launch of this product will
fulfill a currently unmet patient need for an FDA approved liquid
oral dosage form of the vancomycin molecule. This product will
compete in a market that currently exceeds $450 million annually. When launched, ANI
estimates that Vancocin® oral solution could achieve peak sales
potential of $50 million.
Third Quarter Results
Net
Revenues
|
|
Three Months
Ended
|
|
|
|
|
|
(in
thousands)
|
|
September 30,
|
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
30,546
|
|
$
|
30,191
|
|
$
|
355
|
|
1%
|
Branded
pharmaceutical products
|
|
|
15,688
|
|
|
6,834
|
|
|
8,854
|
|
130%
|
Contract
manufacturing
|
|
|
1,829
|
|
|
1,427
|
|
|
402
|
|
28%
|
Contract services and
other income
|
|
|
101
|
|
|
73
|
|
|
28
|
|
38%
|
Total net
revenues
|
|
$
|
48,164
|
|
$
|
38,525
|
|
$
|
9,639
|
|
25%
|
For the three months ended September 30,
2017, ANI reported net revenues of $48.2 million, an increase of 25% from
$38.5 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased
slightly to $30.5 million from
$30.2 million in the prior
period.
- Revenues from sales of branded pharmaceuticals increased 130%,
to $15.7 million from $6.8 million in the prior period, primarily due
to sales of Inderal® XL and InnoPran XL®, both of which were
launched in Q1 2017, as well as increased sales of Inderal® LA and
other branded products.
- Contract manufacturing revenue increased by 28% to $1.8 million from $1.4
million in the prior year period, primarily as a result of
the timing and volume of customer orders.
- Contract services and other income increased by 38%, to
$0.1 million from $73 thousand.
Operating expenses increased to $38.8
million for the three months ended September 30, 2017, from $30.6 million in the prior year period. The
increase was primarily due to a $4.4
million increase in cost of sales as compared with the prior
period, as a result of $2.8 million
of cost of sales related to the net inventory step-up on Inderal®
XL and InnoPran XL® inventory, higher sales of products sold with
profit-sharing arrangements, and increased volume. In addition,
research and development increased by $1.6
million as compared with the prior period, primarily due to
work on the Cortrophin® gel re-commercialization project and
depreciation and amortization increased by $1.1 million as compared with the prior period,
driven by amortization of a higher intangible asset base.
Excluding the $2.8 million of net
inventory step-up costs related to sales of Inderal® XL and
InnoPran XL® in the third quarter of 2017 and the $1.1 million of net inventory step-up costs
related to sales of Inderal® LA and Propranolol ER in the third
quarter of 2016, cost of sales decreased as a percentage of net
revenues to 38% from 40%, primarily as a result of a change in
product mix toward increased sales of branded products with higher
margins.
Net income was $4.7 million for
the three months ended September 30,
2017, as compared to net income of $2.5 million in the prior year period. The
effective tax rate for the three months ended September 30, 2017 was 26%.
Diluted earnings per share for the three months ended
September 30, 2017 was $0.40, based on 11,677 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.22 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $1.11, as compared to adjusted non-GAAP diluted
earnings per share of $0.77 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.
Results for Nine Months Ended September 30, 2017
Net
Revenues
|
|
Nine Months
Ended
|
|
|
|
|
|
(in
thousands)
|
|
September
30,
|
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
88,608
|
|
$
|
65,905
|
|
$
|
22,703
|
|
34%
|
Branded
pharmaceutical products
|
|
|
35,398
|
|
|
19,919
|
|
|
15,479
|
|
78%
|
Contract
manufacturing
|
|
|
5,151
|
|
|
3,977
|
|
|
1,174
|
|
30%
|
Contract services and
other income
|
|
|
399
|
|
|
616
|
|
|
(217)
|
|
(35)%
|
Total net
revenues
|
|
$
|
129,556
|
|
$
|
90,417
|
|
$
|
39,139
|
|
43%
|
For the nine months ended September 30,
2017, ANI reported net revenues of $129.6 million, an increase of 43%
from $90.4 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 34%,
to $88.6 million from $65.9 million in the prior period, primarily due
to sales of the generic products launched during 2016.
- Revenues from sales of branded pharmaceuticals increased 78%,
to $35.4 million from $19.9 million in the prior period, primarily due
to sales of Inderal® XL and InnoPran XL®, both of which were
launched in Q1 2017, as well as sales of Inderal® LA, which
launched in Q2 2016.
- Contract manufacturing revenue increased by 30% to $5.2 million from $4.0
million in the prior year period, primarily as a result of
the timing and volume of customer orders.
- Contract services and other income decreased by 35%, to
$0.4 million from $0.6 million, primarily because sales of
Fenofibrate in the ANI label have replaced the royalties previously
received on the product.
Operating expenses increased to $108.6
million for the nine months ended September 30, 2017, from $71.6 million in the prior year period. The
increase was primarily due to a $26.7
million increase in cost of sales as compared with the prior
period, as a result of higher sales of products sold with
profit-sharing arrangements, increased volume, and $7.5 million of cost of sales related to the
inventory step-up on Inderal® XL, InnoPran XL®, and Inderal® LA
inventory. In addition, depreciation and amortization increased by
$4.4 million as compared with the
prior period, driven by amortization of a higher intangible asset
base.
Excluding the $7.5 million of net
inventory step-up costs related to sales of Inderal® XL, InnoPran
XL®, and Inderal® LA in the nine months ended September 30, 2017 and $3.2 million of net inventory step-up costs
related to sales of Inderal® LA and Propranolol ER in the nine
months ended September 30, 2016, cost
of sales increased as a percentage of net revenues to 39% from 32%,
primarily as a result of increased sales of products with
profit-sharing arrangements.
Net income was $8.6 million for the nine months
ended September 30, 2017, as compared
to net income of $5.0 million in the
prior year period. The effective tax rate for the nine months ended
September 30, 2017 was 29%.
Diluted earnings per share for the nine months ended
September 30, 2017 was $0.73, based on 11,666 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.43 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $2.83, as compared to adjusted non-GAAP diluted
earnings per share of $2.05 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.
Selected Balance Sheet Data
(in thousands)
|
September 30,
2017
|
December 31,
2016
|
|
Cash
|
$
18,031
|
$
27,365
|
|
Accounts receivable,
net
|
$
62,174
|
$
45,895
|
|
Inventory,
net
|
$
38,478
|
$
26,183
|
|
Current
assets
|
$
125,582
|
$
103,007
|
|
Current
liabilities
|
$
36,384
|
$
31,948
|
|
Non-current
debt
|
$
151,284
|
$
120,643
|
|
ANI generated $23.6 million of
positive cash flows from operations in the nine months ended
September 30, 2017. In February 2017, ANI purchased from Cranford
Pharmaceuticals, LLC a distribution license, trademark, and certain
finished goods inventory for Inderal® XL for $20.2 million in cash, using cash on hand. In
February 2017, ANI purchased from
Holmdel Pharmaceuticals, LP the NDA, trademark, and certain
finished goods inventory for InnoPran XL®, including a license to
an Orange Book listed patent, for $30.6
million in cash. ANI made the $30.6
million cash payment using $30.0
million of funds from its Line of Credit and $0.6 million of cash on hand. ANI paid down
$5.0 million on the Line of Credit in
the third quarter of 2017.
ANI Product Development Pipeline
ANI's pipeline consists of 75 products, addressing a total
annual market size of $3.5 billion,
based on data from IMS Health. Of these 75 products, 52 were
acquired and of these acquired products, ANI expects that 45 can be
commercialized based on either CBE-30s or prior approval
supplements filed with the FDA.
Non-GAAP Financial Measures
The Company's fiscal 2017 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, costs related to major
transactions not consummated, and other income / expense. 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, and non-cash impairment charges. 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, costs related to major
transactions not consummated, non-cash interest expense,
depreciation and amortization expense, and non-cash impairment
charges, 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, and non-cash impairment charges.
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 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
Income Statement
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$48,164
|
|
$38,525
|
|
$129,556
|
|
$90,417
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Cost of
sales (excl. depreciation and
amortization)
|
|
|
|
|
|
|
|
|
|
21,078
|
|
16,669
|
|
58,586
|
|
31,874
|
Research and
development
|
|
2,634
|
|
1,041
|
|
6,419
|
|
2,771
|
Selling, general, and
administrative
|
|
8,022
|
|
6,928
|
|
22,695
|
|
20,460
|
Depreciation and
amortization
|
|
7,099
|
|
5,966
|
|
20,906
|
|
16,531
|
|
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
38,833
|
|
30,604
|
|
108,606
|
|
71,636
|
|
|
|
|
|
|
|
|
|
Operating Income
|
|
9,331
|
|
7,921
|
|
20,950
|
|
18,781
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
(3,052)
|
|
(2,856)
|
|
(9,009)
|
|
(8,468)
|
Other
income/(expense), net
|
|
95
|
|
(21)
|
|
58
|
|
(31)
|
|
|
|
|
|
|
|
|
|
Income Before
Provision for Income Taxes
|
|
6,374
|
|
5,044
|
|
11,999
|
|
10,282
|
|
|
|
|
|
|
|
|
|
Provision for Income
Taxes
|
|
(1,654)
|
|
(2,501)
|
|
(3,446)
|
|
(5,268)
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
$
4,720
|
|
$
2,543
|
|
$
8,553
|
|
$
5,014
|
|
|
|
|
|
|
|
|
|
Earnings Per
Share
|
|
|
|
|
|
|
|
|
Basic Earnings Per
Share
|
|
$
0.41
|
|
$
0.22
|
|
$
0.74
|
|
$
0.44
|
Diluted Earnings Per
Share
|
|
$
0.40
|
|
$
0.22
|
|
$
0.73
|
|
$
0.43
|
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,553
|
|
11,465
|
|
11,542
|
|
11,421
|
Diluted
Weighted-Average Shares Outstanding
|
|
11,677
|
|
11,625
|
|
11,666
|
|
11,552
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 2: US GAAP
Balance Sheets
|
(unaudited, in
thousands)
|
|
|
|
|
|
September 30,
2017
|
|
December 31,
2016
|
Current
Assets
|
|
|
|
Cash and cash equivalents
|
$
18,031
|
|
$
27,365
|
Accounts receivable, net
|
62,174
|
|
45,895
|
Inventories, net
|
38,478
|
|
26,183
|
Prepaid income taxes
|
2,052
|
|
-
|
Prepaid expenses and other current assets
|
4,847
|
|
3,564
|
|
|
|
|
Total
Current Assets
|
125,582
|
|
103,007
|
|
|
|
|
Property and
equipment, net
|
17,387
|
|
10,998
|
Restricted
cash
|
5,004
|
|
5,002
|
Deferred tax asset,
net of valuation allowance
|
30,829
|
|
26,227
|
Intangible assets,
net
|
189,829
|
|
175,792
|
Goodwill
|
1,838
|
|
1,838
|
|
|
|
|
Total
Assets
|
$
370,469
|
|
$
322,864
|
|
|
|
|
Current
Liabilities
|
|
|
|
Accounts payable
|
$
5,821
|
|
$
3,389
|
Accrued expenses and other
|
2,741
|
|
927
|
Accrued royalties
|
11,741
|
|
11,956
|
Accrued compensation and related expenses
|
2,009
|
|
1,631
|
Current income taxes payable
|
-
|
|
2,398
|
Accrued government rebates
|
5,755
|
|
5,891
|
Returned goods reserve
|
8,317
|
|
5,756
|
|
|
|
|
Total
Current Liabilities
|
36,384
|
|
31,948
|
|
|
|
|
Long-term royalties
|
-
|
|
625
|
Borrowings on line of credit
|
25,000
|
|
-
|
Convertible notes, net of discount and deferred financing
costs
|
126,284
|
|
120,643
|
|
|
|
|
Total
Liabilities
|
187,668
|
|
153,216
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
Common
stock
|
1
|
|
1
|
Treasury
stock
|
(259)
|
|
-
|
Additional paid-in
capital
|
177,436
|
|
172,563
|
Retained
earnings/(Accumulated deficit)
|
5,623
|
|
(2,916)
|
|
|
|
|
Total
Stockholders' Equity
|
182,801
|
|
169,648
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
$
370,469
|
|
$
322,864
|
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$
4,720
|
|
$
2,543
|
|
$
8,553
|
|
$
5,014
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
3,052
|
|
2,856
|
|
9,009
|
|
8,468
|
Other
income/(expense), net
|
|
(95)
|
|
21
|
|
(58)
|
|
31
|
Provision for income taxes
|
|
1,654
|
|
2,501
|
|
3,446
|
|
5,268
|
Depreciation and amortization
|
|
7,099
|
|
5,966
|
|
20,906
|
|
16,531
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
1,475
|
|
1,365
|
|
4,668
|
|
4,687
|
Excess
of fair value over cost of acquired inventory
|
|
2,757
|
|
1,102
|
|
7,502
|
|
3,179
|
Expenses
related to transaction not consummated
|
|
-
|
|
-
|
|
477
|
|
-
|
Adjusted non-GAAP EBITDA
|
|
$20,662
|
|
$16,354
|
|
$54,503
|
|
$43,178
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 4: Adjusted
non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per
Share Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$
4,720
|
|
$2,543
|
|
$
8,553
|
|
$
5,014
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Non-cash interest expense
|
|
1,789
|
|
1,782
|
|
5,355
|
|
5,264
|
Depreciation and amortization expense
|
|
7,099
|
|
5,966
|
|
20,906
|
|
16,531
|
Stock-based compensation
|
|
1,475
|
|
1,365
|
|
4,668
|
|
4,687
|
Excess of fair value over cost of acquired inventory
|
|
2,757
|
|
1,102
|
|
7,502
|
|
3,179
|
Expenses related to transaction not consummated
|
|
-
|
|
-
|
|
477
|
|
-
|
Less
|
|
|
|
|
|
|
|
|
Tax
impact of adjustments
|
|
(4,854)
|
|
(3,780)
|
|
(14,396)
|
|
(10,975)
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$12,986
|
|
$8,978
|
|
$33,065
|
|
$23,700
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
|
|
|
Shares
Outstanding
|
|
11,677
|
|
11,625
|
|
11,666
|
|
11,552
|
|
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
|
|
|
Diluted Earnings per Share
|
|
$
1.11
|
|
$
0.77
|
|
$
2.83
|
|
$
2.05
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 5:
Cortrophin® Gel Re-Commercialization Milestone
Update
|
|
|
|
|
Step
|
Duration
|
Status
|
Additional
Details
|
Manufacture
small-scale batch of corticotropin API
|
4
mos.
|
Complete
|
• Initial batch
yields similar to historical yields
|
• Analytical method
development and testing ongoing
|
Select drug
product CMO
|
6
mos.
|
Complete
|
• Drug product CMO
has been selected
|
Manufacture
intermediate-scale batches of corticotropin
API
|
2-3 mos. per
batch
|
Ongoing
|
• One batch completed
and second batch to be completed in early November
|
• Further
refine/modernize analytical methods and process
|
• Demonstrate
lot-to-lot consistency
|
• Establish API
specifications
|
Type C meeting
with FDA
|
|
Target
Q42017
|
• Present
re-commercialization plan
|
• Preliminary batch
characterization and comparability data
|
• Updated analytical
methods
|
Manufacture demo
batches of
Cortrophin® Gel
|
TBD
|
Target
Q42017
|
• Initiate
formulation / fill / finish of drug product
|
Manufacture
commercial-scale
batches of corticotropin API
|
2-3 mos. per
batch
|
Target 1H
2018
|
• Process
validation
|
• Registration /
Commercial batches
|
• Initiate
registration-enabling ICH stability studies
|
Manufacture
registration
batches of Cortrophin® Gel
|
TBD
|
TBD
|
• Process
validation
|
• Registration /
Commercial batches
|
• Initiate
registration-enabling ICH stability studies
|
Initiate
registration stability for sNDA
|
6
mos.
|
TBD
|
• Six months of
accelerated stability from drug substance and drug product
batches
at time of submission
|
sNDA
submission
|
TBD
|
TBD
|
• PAS filing - four
month PDUFA date
|
View original
content:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-record-third-quarter-and-year-to-date-2017-results-and-narrows-full-year-guidance-300547546.html
SOURCE ANI Pharmaceuticals, Inc.