BAUDETTE, Minn., Aug. 3, 2017 /PRNewswire/ --
For the second quarter 2017:
- Net revenues of $44.8 million,
an increase of 43% as compared to the same period in 2016
- GAAP net income of $2.7
million and diluted GAAP earnings per share of $0.23
- Adjusted non-GAAP EBITDA of $19.1
million
- Adjusted non-GAAP diluted earnings per share of $0.98
ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today
reported its financial results for the three and six months ended
June 30, 2017, and reaffirmed its
2017 financial guidance. The Company will host its earnings
conference call this morning, August 3,
2017, at 10:30 AM ET.
Investors and other interested parties can join the call by dialing
(866) 776-8875. The conference ID is 51622970.
Financial
Summary
|
|
(in thousands,
except per share data)
|
|
Q2
2017
|
|
Q2
2016
|
|
YTD
2017
|
|
YTD
2016
|
Net
revenues
|
|
$ 44,764
|
|
$ 31,337
|
|
$ 81,392
|
|
$ 51,892
|
Net
income
|
|
$
2,681
|
|
$
1,125
|
|
$
3,833
|
|
$
2,471
|
GAAP earnings per
diluted share
|
|
$
0.23
|
|
$
0.10
|
|
$
0.33
|
|
$
0.21
|
Adjusted non-GAAP
EBITDA(a)
|
|
$ 19,112
|
|
$ 15,445
|
|
$ 33,841
|
|
$ 26,825
|
Adjusted non-GAAP
diluted earnings per share(b)
|
|
$
0.98
|
|
$
0.75
|
|
$
1.72
|
|
$
1.28
|
|
|
(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 43%, 24%, and 31%, 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, as well as the continued impact of products launched
in the second and third quarter of 2016. In addition to our record
results, we launched three products in the second quarter, two from
the ANDA baskets acquired in 2014 and 2015, as well as the first
product launch from our partnership with IDT."
ANI Reaffirms Guidance for the Full Year 2017
ANI's 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, taxes, and the anticipated timing of future product launches
and events.
- Net revenues for 2017 to be between $181 million and
$190 million.
- Cost of sales as a percent of revenues, excluding impact of
inventory step-up, to be between 42% and 44%.
- Adjusted non-GAAP EBITDA to be between $73.1 million and $77.2 million.
- Adjusted non-GAAP diluted earnings per share to be between
$3.58 and $3.94.
Corticotropin Re-commercialization Update
In the second quarter of 2017, ANI's active pharmaceutical
ingredient ("API") manufacturer initiated manufacturing of an
intermediate scale batch of Corticotropin API, which it expects to
complete in the third quarter of 2017. Shortly after
completing the first intermediate scale batch of API, the Company
intends to manufacture a second intermediate scale batch, starting
the third quarter of 2017. ANI has identified a finished
dosage form contract manufacturer and intends to initiate
Corticotropin finished dosage form manufacturing in the third
quarter of 2017. ANI intends to meet and present its
Regulatory Filing Plan to the FDA in the second half of
2017.
For further details, please see ANI's Corticotropin
Re-commercialization Milestone Update in Table 5.
Second Quarter
Results
|
|
Net
Revenues
(in
thousands)
|
|
Three Months
Ended
June 30,
|
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
31,490
|
|
$
|
22,463
|
|
$
|
9,027
|
|
40%
|
Branded
pharmaceutical products
|
|
|
11,671
|
|
|
7,488
|
|
|
4,183
|
|
56%
|
Contract
manufacturing
|
|
|
1,529
|
|
|
1,166
|
|
|
363
|
|
31%
|
Contract services and
other income
|
|
|
74
|
|
|
220
|
|
|
(146)
|
|
(66)%
|
Total net
revenues
|
|
$
|
44,764
|
|
$
|
31,337
|
|
$
|
13,427
|
|
43%
|
For the three months ended June 30,
2017, ANI reported net revenues of $44.8 million, an increase of 43% from
$31.3 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 40%,
to $31.5 million from $22.5 million in the prior period, primarily due
to sales of the generic products launched during 2016.
- Revenues from sales of branded pharmaceuticals increased 56%,
to $11.7 million from $7.5 million in the prior period, primarily due
to sales of Inderal® XL and InnoPran XL®, both of which were
launched in Q1 2017.
- Contract manufacturing revenue increased by 31% to $1.5 million from $1.2
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 66%, to
$0.1 million from $0.2 million, primarily because sales of
Fenofibrate in the ANI label have replaced the royalties previously
received on the product.
Operating expenses increased to $37.8
million for the three months ended June 30, 2017, from $26.1
million in the prior year period. The increase was primarily
due to a $9.3 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 $3.2 million of
cost of sales related to the net inventory step-up on Inderal® XL,
InnoPran XL®, and Inderal® LA inventory. In addition, 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 $3.2 million of net
inventory step-up costs related to sales of Inderal® XL, InnoPran
XL®, and Inderal® LA in the second quarter of 2017 and the
$2.1 million of net inventory step-up
costs related to sales of Inderal® LA and Propranolol ER in the
second quarter of 2016, cost of sales increased as a percentage of
net revenues to 40% from 31%, primarily as a result of increased
sales of products with profit-sharing arrangements.
Net income was $2.7 million for
the three months ended June 30, 2017,
as compared to net income of $1.1
million in the prior year period. The effective tax rate for
the three months ended June 30, 2017
was 32%.
Diluted earnings per share for the three months ended
June 30, 2017 was $0.23, based on 11,667 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.10 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $0.98, as compared to adjusted non-GAAP diluted
earnings per share of $0.75 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 Six
Months Ended June 30, 2017
|
|
Net
Revenues
(in
thousands)
|
|
Six Months
Ended June
30,
|
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
58,061
|
|
$
|
35,715
|
|
$
|
22,346
|
|
63%
|
Branded
pharmaceutical products
|
|
|
19,711
|
|
|
13,084
|
|
|
6,627
|
|
51%
|
Contract
manufacturing
|
|
|
3,322
|
|
|
2,550
|
|
|
772
|
|
30%
|
Contract services and
other income
|
|
|
298
|
|
|
543
|
|
|
(245)
|
|
(45)%
|
Total net
revenues
|
|
$
|
81,392
|
|
$
|
51,892
|
|
$
|
29,500
|
|
57%
|
For the six months ended June 30,
2017, ANI reported net revenues of $81.4 million, an increase of 57%
from $51.9 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 63%,
to $58.1 million from $35.7 million in the prior period, primarily due
to sales of the generic products launched during 2016.
- Revenues from sales of branded pharmaceuticals increased 51%,
to $19.7 million from $13.1 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 2017.
- Contract manufacturing revenue increased by 30% to $3.3 million from $2.6
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 45%, to
$0.3 million from $0.5 million, primarily because sales of
Fenofibrate in the ANI label have replaced the royalties previously
received on the product.
Operating expenses increased to $69.8
million for the six months ended June
30, 2017, from $41.0 million
in the prior year period. The increase was primarily due to a
$22.3 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 $4.7 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 $3.2
million as compared with the prior period, driven by
amortization of a higher intangible asset base.
Excluding the $4.7 million of net
inventory step-up costs related to sales of Inderal® XL, InnoPran
XL®, and Inderal® LA in the six months ended June 30, 2017 and $2.1
million of net inventory step-up costs related to sales of
Inderal® LA and Propranolol ER in the six months ended June 30, 2016, cost of sales increased as a
percentage of net revenues to 40% from 25%, primarily as a result
of increased sales of products with profit-sharing arrangements.
Net income was $3.8 million for the six months ended
June 30, 2017, as compared to net
income of $2.5 million in the prior
year period. The effective tax rate for the six months ended
June 30, 2017 was 32%.
Diluted earnings per share for the six months ended June 30, 2017 was $0.33, based on 11,659 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.21 in the prior year period.
Adjusted non-GAAP diluted earnings per share was $1.72, as compared to adjusted non-GAAP diluted
earnings per share of $1.28 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)
|
|
|
June 30,
2017
|
December 31,
2016
|
Cash
|
$
8,369
|
$
27,365
|
Accounts receivable,
net
|
$
55,513
|
$
45,895
|
Inventory,
net
|
$
42,307
|
$
26,183
|
Current
assets
|
$
112,856
|
$
103,007
|
Current
liabilities
|
$
28,292
|
$
31,948
|
Non-current
debt
|
$
154,381
|
$
120,643
|
ANI generated $6.5 million of
positive cash flows from operations in the six months ended
June 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 Product Development Pipeline
ANI's pipeline consists of 76 products, addressing a total
annual market size of $3.7 billion,
based on data from IMS Health. Of these 76 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; 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$44,764
|
|
$31,337
|
|
$81,392
|
|
$51,892
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Cost of
sales (excl. depreciation and amortization)
|
|
21,122
|
|
11,795
|
|
37,508
|
|
15,205
|
Research
and development
|
|
2,167
|
|
764
|
|
3,785
|
|
1,730
|
Selling,
general, and administrative
|
|
7,380
|
|
7,628
|
|
14,673
|
|
13,532
|
Depreciation and amortization
|
|
7,101
|
|
5,956
|
|
13,807
|
|
10,565
|
|
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
37,770
|
|
26,143
|
|
69,773
|
|
41,032
|
|
|
|
|
|
|
|
|
|
Operating Income
|
|
6,994
|
|
5,194
|
|
11,619
|
|
10,860
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
(3,025)
|
|
(2,830)
|
|
(5,957)
|
|
(5,612)
|
Other
expense, net
|
|
(19)
|
|
(12)
|
|
(37)
|
|
(10)
|
|
|
|
|
|
|
|
|
|
Income Before
Provision for Income Taxes
|
|
3,950
|
|
2,352
|
|
5,625
|
|
5,238
|
|
|
|
|
|
|
|
|
|
Provision for Income
Taxes
|
|
(1,269)
|
|
(1,227)
|
|
(1,792)
|
|
(2,767)
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
$
2,681
|
|
$
1,125
|
|
$
3,833
|
|
$
2,471
|
|
|
|
|
|
|
|
|
|
Earnings Per
Share
|
|
|
|
|
|
|
|
|
Basic Earnings Per
Share
|
|
$
0.23
|
|
$
0.10
|
|
$
0.33
|
|
$
0.22
|
Diluted Earnings Per
Share
|
|
$
0.23
|
|
$
0.10
|
|
$
0.33
|
|
$
0.21
|
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,546
|
|
11,402
|
|
11,536
|
|
11,398
|
Diluted
Weighted-Average Shares Outstanding
|
|
11,667
|
|
11,541
|
|
11,659
|
|
11,514
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 2: US GAAP
Balance Sheets
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2017
|
|
December 31,
2016
|
|
Current
Assets
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
8,369
|
|
$
27,365
|
|
Accounts receivable, net
|
|
55,513
|
|
45,895
|
|
Inventories, net
|
|
42,307
|
|
26,183
|
|
Prepaid income taxes
|
|
3,991
|
|
-
|
|
Prepaid expenses and other current assets
|
|
2,676
|
|
3,564
|
|
|
|
|
|
|
|
Total
Current Assets
|
|
112,856
|
|
103,007
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
14,966
|
|
10,998
|
|
Restricted
cash
|
|
5,002
|
|
5,002
|
|
Deferred tax asset,
net of valuation allowance
|
|
27,933
|
|
26,227
|
|
Intangible assets,
net
|
|
196,624
|
|
175,792
|
|
Goodwill
|
|
1,838
|
|
1,838
|
|
|
|
|
|
|
|
Total
Assets
|
|
$359,219
|
|
$
322,864
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
Accounts payable
|
|
$
3,153
|
|
$
3,389
|
|
Accrued expenses and other
|
|
1,565
|
|
927
|
|
Accrued royalties
|
|
11,255
|
|
11,956
|
|
Accrued compensation and related expenses
|
|
1,227
|
|
1,631
|
|
Current income taxes payable
|
|
-
|
|
2,398
|
|
Accrued government rebates
|
|
3,534
|
|
5,891
|
|
Returned goods reserve
|
|
7,558
|
|
5,756
|
|
|
|
|
|
|
|
Total
Current Liabilities
|
|
28,292
|
|
31,948
|
|
|
|
|
|
|
|
Long-term royalties
|
|
-
|
|
625
|
|
Borrowings on line of credit
|
|
30,000
|
|
-
|
|
Convertible notes, net of discount and deferred financing
costs
|
|
124,381
|
|
120,643
|
|
|
|
|
|
|
|
Total
Liabilities
|
|
182,673
|
|
153,216
|
|
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
|
|
Common
stock
|
|
1
|
|
1
|
|
Treasury
stock
|
|
(259)
|
|
-
|
|
Additional paid-in
capital
|
|
175,901
|
|
172,563
|
|
Retained
earnings/(Accumulated deficit)
|
|
903
|
|
(2,916)
|
|
|
|
|
|
|
|
Total
Stockholders' Equity
|
|
176,546
|
|
169,648
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity
|
|
$359,219
|
|
$
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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$
2,681
|
|
$
1,125
|
|
$
3,833
|
|
$
2,471
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
3,025
|
|
2,830
|
|
5,957
|
|
5,612
|
Other
expense, net
|
|
19
|
|
12
|
|
37
|
|
10
|
Provision for income taxes
|
|
1,269
|
|
1,227
|
|
1,792
|
|
2,767
|
Depreciation and amortization
|
|
7,101
|
|
5,956
|
|
13,807
|
|
10,565
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
1,807
|
|
2,217
|
|
3,193
|
|
3,322
|
Excess
of fair value over cost of acquired inventory
|
|
3,210
|
|
2,078
|
|
4,745
|
|
2,078
|
Expenses
related to transaction not consummated
|
|
-
|
|
-
|
|
477
|
|
-
|
Adjusted non-GAAP EBITDA
|
|
$19,112
|
|
$15,445
|
|
$33,841
|
|
$26,825
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 4: Adjusted
non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per
Share Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$
2,681
|
|
$1,125
|
|
$
3,833
|
|
$
2,471
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Non-cash interest expense
|
|
1,774
|
|
1,757
|
|
3,566
|
|
3,482
|
Depreciation and amortization expense
|
|
7,101
|
|
5,956
|
|
13,807
|
|
10,565
|
Stock-based compensation
|
|
1,807
|
|
2,217
|
|
3,193
|
|
3,322
|
Excess of fair value over cost of acquired inventory
|
|
3,210
|
|
2,078
|
|
4,745
|
|
2,078
|
Expenses related to transaction not consummated
|
|
-
|
|
-
|
|
477
|
|
-
|
Less
|
|
|
|
|
|
|
|
|
Tax
impact of adjustments
|
|
(5,140)
|
|
(4,443)
|
|
(9,542)
|
|
(7,195)
|
|
|
|
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$11,433
|
|
$8,690
|
|
$20,079
|
|
$14,723
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
|
|
|
|
Shares
Outstanding
|
|
11,667
|
|
11,541
|
|
11,659
|
|
11,514
|
|
|
|
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
|
|
|
|
Diluted Earnings per Share
|
|
$
0.98
|
|
$
0.75
|
|
$
1.72
|
|
$
1.28
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 5:
Corticotropin 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
|
• Initiate
stability testing
|
Select drug
product CMO
|
6
mos.
|
Ongoing
|
• Drug
product CMO has been identified
|
Manufacture
intermediate-scale batches of corticotropin
API
|
2-3 mos. per
batch
|
Ongoing
|
• Demonstrate
lot to lot consistency
|
• Further
refine/modernize analytical methods and process
|
• Establish
API specifications
|
Type C meeting
with FDA
|
|
Target
2H2017
|
• Present
re-commercialization plan
|
• Preliminary
batch characterization and comparability data
|
• Updated
analytical methods
|
Manufacture demo
batches of Cortrophin Gel
|
TBD
|
Target
2H2017
|
• Initiate
formulation / fill / finish of drug product
|
Manufacture
commercial-scale batches of corticotropin API
|
2-3 mos. per
batch
|
Not
started
|
• Process
validation
|
•
Registration / Commercial batches
|
• Initiate
registration-enabling ICH stability studies
|
Manufacture
registration batches of Cortrophin Gel
|
TBD
|
Not
started
|
• Process
validation
|
•
Registration / Commercial batches
|
• Initiate
registration-enabling ICH stability studies
|
Initiate
registration stability for sNDA
|
6
mos.
|
Not
started
|
• 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-second-quarter-and-year-to-date-2017-results-and-reaffirms-guidance-300498387.html
SOURCE ANI Pharmaceuticals, Inc.