BAUDETTE, Minn., Nov. 3, 2014 /PRNewswire/ -- ANI Pharmaceuticals,
Inc. ("ANI") (NASDAQ: ANIP) today reported financial results for
the three and nine months ended September
30, 2014 and increased its revenue and non-GAAP EBITDA
guidance for the fourth quarter of 2014.
Third quarter net revenues were $17.4 million, an increase of 122% as
compared to $7.8 million for the same
period in 2013. Third quarter adjusted non-GAAP EBITDA was
$10.1 million, an
increase of 494% as compared to $1.7
million in the same period in 2013. Third quarter operating
income was $8.2 million, an increase
of 912% as compared to $0.8 million
in the same period in 2013. Third quarter adjusted non-GAAP diluted
earnings per share was $0.66. Third
quarter diluted earnings per share was $0.59, an increase of 354% as compared to
$0.13 in the same period in 2013.
Also during the quarter, ANI acquired two mature brands,
Lithobid® and Vancocin®, for a combined
$23 million.
Arthur S. Przybyl, President and
CEO, stated,
"ANI had a record third quarter across all major metrics of
revenue, EBITDA, operating income, and earnings per share. Our
third quarter financial results were the direct result of continued
organic revenue growth, combined with the revenues from Lithobid
and Vancocin, products we acquired in the third quarter. Third
quarter results include two months of revenue from Vancocin and its
authorized generic. We expect to launch Vancocin under our own
label in the fourth quarter. We continue to advance our internal
generic product development efforts while selectively pursuing
acquisitions and partnerships for late stage ANDA products and
mature brands."
ANI's Guidance for the Fourth Quarter of 2014
ANI's guidance for the fourth quarter of 2014 is based on
management's current estimates of the Company's market share for
its products, product pricing, cost of sales, and operating
costs.
- Net revenues estimated to be between $17 million and
$18 million.
- Adjusted non-GAAP EBITDA, excluding non-cash stock compensation
expense, estimated to be between $9.75 million and $10.25 million.
- Adjusted non-GAAP earnings per share, excluding non-cash stock
compensation expense, estimated to be between $0.60 and $0.65 per share, assuming 11,318,014 shares
outstanding.
- An estimated effective tax rate of 18%.
The guidance above does not take into account additional product
launches during the fourth quarter of 2014. ANI will provide
initial 2015 guidance in conjunction with the announcement of its
fourth quarter and year-end financial results.
Year-to-Date Highlights Include:
- Year-to-date net revenues of $34.9 million, an increase of 79% as
compared to $19.6 million for the
same period in 2013.
- Year-to-date adjusted non-GAAP EBITDA of $14.5 million, an increase of 306% as
compared to $3.6 million for the same
period in 2013.
- Year-to-date operating income of $9.2
million, an increase of $11.8
million as compared to an operating loss of $2.6 million for the same period in 2013.
- Acquired Vancocin® NDA and related
ANDAs from Shire on August 1,
2014.
- Acquired Lithobid® NDA from Noven
Therapeutics on July 1, 2014.
- Acquired ANDAs for 31 generic products from Teva
Pharmaceuticals.
- Filed an ANDA with the FDA for an anti-cancer drug, which was
granted an expedited review.
- Entered into a collaborative arrangement for a second generic
drug product with Sofgen Pharmaceuticals.
- Entered into a collaborative arrangement for a generic drug
product with Dexcel Pharma Technologies Ltd.
- Entered into two development agreements for generic drugs with
Sterling Pharmaceutical Services.
- Completed a follow-on public offering of common stock yielding
net proceeds of $46.7 million.
Net revenues and
Adjusted Non-GAAP EBITDA
|
(in
thousands)
|
Three months
ended
September
30,
|
Nine months
ended
September
30,
|
|
2014
|
2013
|
2014
|
2013
|
Net
revenues
|
$ 17,387
|
$ 7,836
|
$ 34,933
|
$ 19,550
|
Adjusted Non-GAAP
EBITDA(a)
|
$ 10,078
|
$ 1,696
|
$ 14,549
|
$ 3,582
|
(a) See
Table 2 for US GAAP reconciliation.
|
Third Quarter Results
For the three months ended September 30,
2014, ANI reported net revenues of $17.4 million, an increase of 122%
from $7.8 million in the prior year
period. The increase in revenues was due to a 135% increase in net
prescription sales from $6.4 million
to $15.0 million,
primarily as a result of sales of ANI's newly acquired products,
Lithobid and Vancocin, as well as price increases for the Company's
existing products. Contract sales, development services, and
royalty revenues increased from $1.5
million to $2.4 million, primarily due to
royalties received on sales of the authorized generic of
Vancocin.
Adjusted non-GAAP EBITDA was $10.1 million for the three months
ended September 30, 2014, compared
to $1.7 million in the prior year
period, an increase of 494%. For a reconciliation of adjusted
non-GAAP EBITDA to GAAP operating income, please see Table
2.
Cost of sales decreased as a percentage of net revenues to 18%
from 35%, primarily due to higher margin sales of the newly
acquired Lithobid and Vancocin branded products, as well as price
increases for the Company's existing products.
Research and development costs were $0.9 million and $0.5 million for the three months ended
September 30, 2014 and 2013,
respectively. The increase was due to work on new development
projects, including the Teva products and the collaborations with
Sterling and Sofgen.
Selling, general and administrative expenses increased to
$4.1 million for the
three months ended September 30,
2014, from $3.5 million in the
prior year period. The increase was primarily due to $692 thousand in non-cash stock-based
compensation expense recognized during the quarter.
Operating income was $8.2 million for the three months
ended September 30, 2014, as compared
to $0.8 million in the prior year
period. The third quarter 2013 operating income included
$0.5 million of merger-related
expenses.
Net income was $6.7 million for the three months
ended September 30, 2014, as compared
to $1.2 million in the prior year
period. Diluted earnings per share for the three months ended
September 30, 2014 was $0.59, based on 11,302,319 diluted shares
outstanding, as compared with earnings per share of $0.13 in the prior year period.
Adjusted non-GAAP diluted earnings per share, excluding non-cash
stock compensation expense, was $0.66. For a reconciliation of adjusted non-GAAP
diluted earnings per share to GAAP net income, please see Table
3.
Results for Nine Months Ended September 30, 2014
For the nine months ended September 30,
2014, ANI reported net revenues of $34.9 million, an increase of 79%
from $19.5 million in the prior year
period. The increase in revenues was due to a 111% increase in net
prescription sales from $13.8 million
to $29.2 million,
primarily as a result of increased existing product sales, as well
as sales of ANI's newly acquired products, Lithobid and Vancocin.
Contract sales, development services, and royalty revenues were
$5.7 million, consistent with the
prior year period. Royalties received on sales of the authorized
generic of Vancocin fully offset decreased contract manufacturing
revenue during the quarter.
Adjusted non-GAAP EBITDA was $14.5 million for the nine months
ended September 30, 2014, as compared
to $3.6 million in the prior year
period, an increase of 306%. For a reconciliation of adjusted
non-GAAP EBITDA to GAAP operating income, please see Table
2.
Cost of sales decreased as a percentage of net revenues to 22%
from 37%, primarily due to price increases for the Company's
existing products, as well as higher margin sales of the newly
acquired Lithobid and Vancocin branded products.
Research and development costs were $2.1
million and $1.2 million for
the nine months ended September 30,
2014 and 2013, respectively. The increase was due to work on
new development projects, including the Teva products, the new
collaborations with Sterling and Sofgen, and a filing fee for an
ANDA submission of an anti-cancer drug.
Selling, general and administrative expenses increased to
$13.2 million for the nine months
ended September 30, 2014 from
$13.0 million in the prior year
period. The slight increase was due to increases in personnel and
consulting, legal, and other fees related to becoming a public
company, as well as $2.7 million of
non-cash stock compensation expense, of which $1.3 million was a catch-up charge recognized
upon shareholder approval of an increase in shares available for
issuance under ANI's stock compensation plan. These increases were
partially offset by the lack of $5.5
million of merger-related expenses incurred in the first
nine months of 2013.
Operating income was $9.2 million for the nine months
ended September 30, 2014, as compared
to a $2.6 million operating loss in
the prior year period. The year-to-date 2013 operating loss
included $5.5 million of
merger-related expenses.
Net income was $7.7 million for the nine months
ended September 30, 2014, as compared
to a $3.1 million loss in the prior
year period. Diluted earnings per share for the nine months ended
September 30, 2014 was $0.70, based on 10,865,142 diluted shares
outstanding and an effective tax rate of 17%.
Selected Balance
Sheet Data
|
(in
thousands)
|
|
|
September
30,
|
December
31,
|
|
2014
|
2013
|
Cash
|
$
35,050
|
$
11,105
|
Accounts
Receivable
|
$
14,570
|
$
12,513
|
Inventory
|
$
7,346
|
$
3,518
|
Current
Assets
|
$
57,565
|
$
27,716
|
Current
Liabilities
|
$
8,145
|
$
3,538
|
ANI generated $4.2 million and
$11.3 million of positive cash flows
from operations in the third quarter and in the first nine months
of 2014, respectively. As a result of these cash flows from
operations and a follow-on public offering completed during the
first quarter, net of $34.6 million
of payments for product acquisitions, ANI had $35.1 million of cash at September 30, 2014. Accounts receivable increased
from $12.5 million to $14.6 million. ANI's inventory
increased from $3.5 million to
$7.3 million as a
direct result of raw materials acquired for key products, and
inventories related to Lithobid and Vancocin. ANI's total current
assets increased by $29.9 million to $57.6 million at September 30, 2014, from $27.7 million at December
31, 2013.
Total shares issued and outstanding at September 30, 2014 were 11,318,014.
ANI Product
Development Pipeline
|
|
Products
|
|
ANI
|
|
Partnered
|
|
Total
|
At FDA
|
|
6
|
|
3
|
|
9
|
Development
|
|
4
|
|
5
|
|
9
|
Teva
Products
|
|
31
|
|
0
|
|
31
|
ANI's product development pipeline includes extended-release
products, narcotics, anti-cancers, oral solutions, suspensions and
solid dosage forms. These forty-nine generic products address a
total annual market size of approximately $2.7 billion, based on data from IMS Health.
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 operation
results unaffected by non-cash stock-based compensation,
merger-related expenses, 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 operating income/(loss),
excluding depreciation, amortization, stock-based compensation
expense, and merger-related operating expenses. 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 2.
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 operation results unaffected by non-cash stock-based
compensation. Management uses adjusted non-GAAP diluted earnings
per share when analyzing Company performance.
Adjusted non-GAAP diluted earnings per share is defined as net
income/(loss), excluding stock-based compensation expense, divided
by the diluted weighted average shares outstanding during the
period. Adjusted non-GAAP diluted earnings per share should be
considered in addition to, but not in lieu of, 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 3.
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing branded and generic prescription
pharmaceuticals. The Company's targeted areas of product
development currently include narcotics, oncolytics (anti-cancers),
hormones and steroids, and complex formulations involving extended
release and combination products. 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, 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; delays
or failure in obtaining product approval 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
(218) 634-3608
IR@anipharmaceuticals.com
ANI
Pharmaceuticals, Inc. and Subsidiary
|
Table 1: US GAAP
Income Statement
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
September 30,
|
|
Nine months
ended
September 30,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$ 17,387
|
|
$ 7,836
|
|
$ 34,933
|
|
$ 19,550
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Cost of sales
(excl. depreciation and
amortization)
|
|
3,061
|
|
2,710
|
|
7,800
|
|
7,290
|
Research and
development
|
|
883
|
|
454
|
|
2,110
|
|
1,188
|
Selling,
general and administrative
|
|
4,057
|
|
3,480
|
|
13,193
|
|
12,961
|
Depreciation
and amortization
|
|
1,187
|
|
382
|
|
2,596
|
|
673
|
|
|
|
|
|
|
|
|
|
Total
Operating Expenses
|
|
9,188
|
|
7,026
|
|
25,699
|
|
22,112
|
|
|
|
|
|
|
|
|
|
Operating
(Loss)/Income
|
|
8,199
|
|
810
|
|
9,234
|
|
(2,562)
|
|
|
|
|
|
|
|
|
|
Other
Income/(Expense)
|
|
|
|
|
|
|
|
|
Interest
income/(expense)
|
|
10
|
|
-
|
|
13
|
|
(467)
|
Other
expense
|
|
82
|
|
148
|
|
72
|
|
(336)
|
|
|
|
|
|
|
|
|
|
(Loss)/Income Before
Income Tax Benefit/(Provision)
|
|
8,291
|
|
958
|
|
9,319
|
|
(3,365)
|
|
|
|
|
|
|
|
|
|
Income tax
benefit/(provision)
|
|
(1,545)
|
|
83
|
|
(1,577)
|
|
83
|
|
|
|
|
|
|
|
|
|
Net Income/(Loss)
from Continuing Operations
|
|
6,746
|
|
1,041
|
|
7,742
|
|
(3,282)
|
|
|
|
|
|
|
|
|
|
Gain on discontinued operation, net of provision (benefit) for
income taxes
|
|
-
|
|
150
|
|
0
|
|
150
|
|
|
|
|
|
|
|
|
|
Net
Income/(Loss)
|
|
6,746
|
|
1,191
|
|
7,742
|
|
(3,132)
|
|
|
|
|
|
|
|
|
|
Basic Earnings
(Loss) Per Share
|
|
|
|
|
|
|
|
|
Continuing
Operations
|
|
$ 0.59
|
|
$ 0.11
|
|
$ 0.71
|
|
$ (2.31)
|
Discontinued Operations
|
|
-
|
|
0.02
|
|
-
|
|
0.04
|
Basic Earnings/(Loss)
Per Share
|
|
$ 0.59
|
|
$ 0.13
|
|
$ 0.71
|
|
$ (2.27)
|
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average Shares
Outstanding
|
|
11,235
|
|
9,480
|
|
10,824
|
|
3,577
|
|
|
|
|
|
|
|
|
|
Diluted Earnings
(Loss) Per Share
|
|
|
|
|
|
|
|
|
Continuing
Operations
|
|
$ 0.59
|
|
$ 0.11
|
|
$ 0.70
|
|
$ (2.31)
|
Discontinued
Operations
|
|
-
|
|
0.02
|
|
-
|
|
0.04
|
Diluted
Earnings/(Loss) Per Share
|
|
$ 0.59
|
|
$ 0.13
|
|
$ 0.70
|
|
$ (2.27)
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average Shares
Outstanding
|
|
11,302
|
|
9,480
|
|
10,865
|
|
3,577
|
ANI
Pharmaceuticals, Inc. and Subsidiary
|
Table 2: 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,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
Operating
(Loss)/Income
|
|
$8,199
|
|
$810
|
|
$9,234
|
|
($2,562)
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
1,187
|
|
382
|
|
2,596
|
|
673
|
|
|
|
|
|
|
|
|
|
Add
back
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
692
|
|
3
|
|
2,719
|
|
3
|
Merger-related expenses, not already added back
|
|
-
|
|
501
|
|
-
|
|
5,468
|
Adjusted
EBITDA
|
|
$10,078
|
|
$1,696
|
|
$14,549
|
|
$3,582
|
ANI
Pharmaceuticals, Inc. and Subsidiary
|
Table 3: Adjusted
non-GAAP Diluted Earnings Per Share Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
Three months
ended
September 30, 2014
|
|
|
|
Net Income
|
|
6,746
|
|
|
|
Add back
|
|
|
Stock-based compensation
|
|
692
|
|
|
|
Adjusted Net Income
Used in Calculating Adjusted non-GAAP Diluted Earnings Per
Share
|
|
$
7,438
|
|
|
|
|
|
|
Diluted
Weighted-Average Shares
Outstanding
|
|
11,302
|
|
|
|
Adjusted
non-GAAP Diluted Earnings Per
Share
|
|
$
0.66
|
SOURCE ANI Pharmaceuticals