BAUDETTE, Minn., Feb. 19, 2015 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported
financial results for the three and twelve months ended
December 31, 2014 and announced its
revenue, non-GAAP EBITDA, and non-GAAP earnings per share guidance
for the 2015 year.
Fourth quarter net revenues were $21.0 million, an increase of 100% as
compared to $10.5 million for the
same period in 2013. Fourth quarter adjusted non-GAAP EBITDA was
$12.8 million, an
increase of 225% as compared to $3.9
million in the same period in 2013. Fourth quarter operating
income was $10.8 million, an increase
of 211% as compared to $3.5 million
in the same period in 2013. Fourth quarter adjusted non-GAAP
diluted earnings per share was $1.94.
Fourth quarter diluted earnings per share, calculated under U.S.
GAAP, was $1.82, an increase of 406%
as compared to $0.36 in the same
period in 2013. Both earnings per share calculations include the
positive impact of a $16.7 million
reversal of valuation allowances previously recorded against ANI's
deferred tax assets. This reversal is based on the Company's
expectation of future profitability, among other factors. Also
during the quarter, ANI closed a public offering of convertible
debt, netting proceeds of $122.6
million.
Arthur S. Przybyl, President and
CEO, stated,
"ANI had a record fourth quarter across all major metrics of
revenue, EBITDA, operating income, earnings per share, and
operating cash flows. Our fourth quarter financial results were the
direct result of continued organic revenue growth, combined with
the impact of revenues from Lithobid and Vancocin, products we
acquired in the third quarter. In the fourth quarter we also
launched Vancocin under our own ANI label and the first of our
products acquired from Teva, Methazolamide.
2014 was an exciting year for ANI. We completed three
transactions, acquiring 33 generic drug products and two mature
brand NDAs, and we raised over $193
million through common stock and convertible debt
financings. At the end of the year we had over $169 million of cash on hand that will help us
continue to implement our strategy of advancing our internal
generic product development efforts while selectively pursuing
acquisitions and partnerships for late stage generic products and
mature brands."
ANI's Guidance for the Full Year 2015
ANI's guidance for 2015 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 $80 million and $88 million.
- Cost of sales, exclusive of depreciation and amortization, of
between 15% and 17.5%.
- Operating expenses of between $16.2 and
$16.5 million, excluding non-cash stock compensation expense
of approximately $2.8 million.
- Research and development costs of approximately $3.0 million.
- Adjusted non-GAAP EBITDA, which excludes non-cash stock
compensation expense, estimated to be between $48.8 million and $53.1 million.
- Depreciation and amortization expense of approximately
$5.5 million.
- Total interest expense of approximately $11.2 million. This includes cash interest
expense of approximately $4.3 million
and non-cash interest expense of approximately $6.9 million.
- An estimated effective tax rate of 36%.
- Adjusted non-GAAP earnings per share, which excludes non-cash
stock compensation and non-cash interest expense, estimated to be
between $2.48 and $2.72, assuming
11,476,281 weighted average shares outstanding.
The 2015 adjusted non-GAAP earnings per share guidance above
represents an increase of between 68% and 84% when compared to pro
forma adjusted non-GAAP earnings per share for 2014. See Table 4
for a calculation of pro forma adjusted non-GAAP earnings per share
for the quarter and year ended December 31,
2014 and a reconciliation to US GAAP.
The guidance above assumes a stable market share for EEMT and
does not take into account the effect of any additional new product
launches or acquisitions that could potentially occur throughout
2015.
Year-to-Date Highlights Include:
- Year-to-date net revenues of $56.0 million, an increase of 86% as
compared to $30.1 million for the
same period in 2013.
- Year-to-date adjusted non-GAAP EBITDA of $27.3 million, an increase of 264% as
compared to $7.5 million for the same
period in 2013.
- Year-to-date operating income of $20.0
million, an increase of $19.1
million as compared to $0.9
million for the same period in 2013.
- Successful completion of a convertible debt offering, netting
proceeds of $122.6 million in
December 2014.
- Launched Methazolamide USP 25mg and 50mg oral tablets in
November 2014.
- Filed an ANDA with the FDA for an anti-cancer drug, which was
granted an expedited review in August
2014.
- Acquired Vancocin® NDA and related ANDAs in
August 2014.
- Acquired Lithobid® NDA in July 2014.
- Completed a follow-on public offering of common stock yielding
net proceeds of $46.7 million in
March 2014.
- Acquired ANDAs for 31 generic products in January 2014.
Net revenues and
Adjusted
|
|
|
Non-GAAP
EBITDA
|
|
|
(in
thousands)
|
Three months
ended
|
Year
ended
|
|
December
31,
|
December
31,
|
|
2014
|
2013
|
2014
|
2013
|
Net
revenues
|
$ 21,037
|
$ 10,532
|
$ 55,970
|
$ 30,082
|
Adjusted Non-GAAP
EBITDA(a)
|
$ 12,758
|
$ 3,930
|
$ 27,307
|
$ 7,512
|
|
|
|
|
|
|
|
|
(a) See Table 2 for
US GAAP reconciliation.
|
Fourth Quarter Results
For the three months ended December 31,
2014, ANI reported net revenues of $21.0 million, an increase of 100%
from $10.5 million in the prior year
period. The increase in revenues was due to a 100% increase in net
prescription sales from $8.8 million
to $17.6 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 $1.7
million to $3.4 million, primarily due to
royalties received on sales of the authorized generic of
Vancocin.
Adjusted non-GAAP EBITDA was $12.8 million for the three months
ended December 31, 2014, compared to
$3.9 million in the prior year
period, an increase of 225%. 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 17%
from 25%, 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 $0.6 million and $0.5 million for the three months ended
December 31, 2014 and 2013,
respectively. The slight increase was due to work on new
development projects, including the Teva products and the
development projects with Sterling.
Selling, general and administrative expenses increased to
$4.7 million for the
three months ended December 31, 2014,
from $3.4 million in the prior year
period. The increase was primarily due to $704 thousand in non-cash stock-based
compensation expense recognized during the quarter, as well
increases in personnel and compensation expense.
Operating income was $10.8 million for the three months
ended December 31, 2014, as compared
to $3.5 million in the prior year
period.
Net income was $21.0 million for the three months
ended December 31, 2014, as compared
to $3.4 million in the prior year
period. Fourth quarter 2014 net income includes a $16.7 million tax benefit from the reversal of
the majority of the valuation allowance previously recorded against
the Company's deferred tax assets. Diluted earnings per share for
the three months ended December 31,
2014 was $1.82, based on
11,476,281 diluted shares outstanding, as compared with earnings
per share of $0.36 in the prior year
period.
Adjusted non-GAAP diluted earnings per share was $1.94. For a reconciliation of adjusted non-GAAP
diluted earnings per share to GAAP net income, please see Table
3.
Results for the Year Ended December
31, 2014
For the year ended December 31,
2014, ANI reported net revenues of $56.0 million, an increase of 86%
from $30.1 million in the prior year
period. The increase in revenues was due to a 107% increase in net
prescription sales from $22.7 million
to $46.9 million,
primarily as a result of price increases for the Company's existing
products, as well as sales of ANI's newly acquired products,
Lithobid and Vancocin. Contract sales, development services, and
royalty revenues increased from $7.4
million to $9.1 million, due
primarily to royalties received on sales of the authorized generic
of Vancocin in the last five months of the year.
Adjusted non-GAAP EBITDA was $27.3 million for the year ended
December 31, 2014, as compared to
$7.5 million in the prior year
period, an increase of 264%. 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 20%
from 33%, 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 $2.7
million and $1.7 million for
the years ended December 31, 2014 and
2013, respectively. The increase was due to work on new development
projects, including the Teva products, the new projects with
Sterling and Sofgen, and a filing fee for an ANDA submission of an
anti-cancer drug.
Selling, general and administrative expenses increased to
$17.9 million for the year ended
December 31, 2014 from $16.4 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 $3.4 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 2013.
Operating income was $20.0 million for the year ended
December 31, 2014, as compared to
$0.9 million in the prior year
period. Operating income in 2013 included $5.5 million of merger-related expenses.
Net income was $28.7 million for the year ended
December 31, 2014, as compared to
$0.3 million in the prior year
period. Net income for 2014 includes a $16.7
million tax benefit from the reversal of the majority of the
valuation allowance previously recorded against the Company's
deferred tax assets. Diluted earnings per share for the year ended
December 31, 2014 was $2.59, based on 11,052,931 diluted shares
outstanding.
Adjusted non-GAAP diluted earnings per share was $2.96. For a reconciliation of adjusted non-GAAP
diluted earnings per share to GAAP net income, please see Table
3.
Selected Balance
Sheet Data
|
|
(in
thousands)
|
|
|
|
December
31,
|
December
31,
|
|
2014
|
2013
|
Cash
|
$
169,037
|
$
11,105
|
Accounts Receivable,
net
|
$
17,297
|
$
12,513
|
Inventory,
net
|
$
7,518
|
$
3,518
|
Current
Assets
|
$
203,478
|
$
27,716
|
Current
Liabilities
|
$
13,233
|
$
3,538
|
ANI generated $10.7 million and
$22.0 million of positive cash flows
from operations in the fourth quarter and in the year ended
December 31, 2014, respectively. In
the first quarter, ANI completed a follow-on public offering,
netting $46.7 million. In the fourth
quarter, ANI closed a public offering of $143.8 million of convertible debt, with
simultaneous bond hedge and warrant transactions, netting proceeds
of $122.6 million. The convertible
notes have a conversion price of $69.48, but in entering into the bond hedge and
warrant transactions, the effective conversion price was raised to
$96.21 per share from the Company's
perspective. As a result of these cash inflows, net of $34.6 million in payments for product
acquisitions, ANI had $169.0 million of cash at
December 31, 2014.
Accounts receivable, net, increased from $12.5 million to $17.3 million. ANI's inventory, net,
increased from $3.5 million to
$7.5 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
$175.8 million to
$203.5 million at
December 31, 2014, from $27.7 million at December
31, 2013.
Total shares issued and outstanding at December 31, 2014 were 11,387,860.
ANI Product
Development Pipeline
|
|
|
|
|
|
|
|
Products
|
|
ANI
|
|
Partnered
|
|
Total
|
At FDA
|
|
6
|
|
3
|
|
9
|
Development
|
|
5
|
|
3
|
|
8
|
Teva
Products
|
|
29
|
|
0
|
|
29
|
In November 2014 and January 2015, ANI launched two of the products
acquired from Teva. ANI's product development pipeline includes
extended-release products, narcotics, anti-cancers, oral solutions,
suspensions and solid dosage forms. These forty-six generic
products address a total annual market size of approximately
$3.0 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 operating results unaffected by non-cash stock-based
compensation and non-cash interest expense. 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 and non-cash
interest 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.
Pro Forma Adjusted non-GAAP Diluted Earnings per
Share
ANI's management considers pro forma adjusted non-GAAP diluted
earnings per share to be an important financial indicator of ANI's
operating performance, providing investors and analysts with a pro
forma measure of operating results that can be compared across
reporting periods. Management uses pro forma adjusted non-GAAP
diluted earnings per share when analyzing Company performance.
Pro forma adjusted non-GAAP diluted earnings per share is
defined as income/(loss) before income tax benefit/(provision),
less pro forma tax expense at an effective tax rate of 36%, and
excluding non-cash stock-based compensation and non-cash interest
expense, divided by the diluted weighted average shares outstanding
during the period. Pro forma 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
pro forma 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 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 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; 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
December 31,
|
|
Year ended
December 31,
|
|
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
Net
Revenues
|
|
$ 21,037
|
|
$ 10,532
|
|
$ 55,970
|
|
$ 30,082
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
Cost of
sales (excl. depreciation
and amortization)
|
|
|
|
|
|
|
|
|
|
3,673
|
|
2,684
|
|
11,473
|
|
9,974
|
Research and
development
|
|
568
|
|
524
|
|
2,678
|
|
1,712
|
Selling,
general and administrative
|
|
4,742
|
|
3,427
|
|
17,935
|
|
16,388
|
Depreciation
and amortization
|
|
1,282
|
|
437
|
|
3,878
|
|
1,110
|
|
|
|
|
|
|
|
|
|
Total Operating
Expenses
|
|
10,265
|
|
7,072
|
|
35,964
|
|
29,184
|
|
|
|
|
|
|
|
|
|
Operating Income
|
|
10,772
|
|
3,460
|
|
20,006
|
|
898
|
|
|
|
|
|
|
|
|
|
Other
Income/(Expense)
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(800)
|
|
-
|
|
(787)
|
|
(467)
|
Other
income/(expense)
|
|
88
|
|
31
|
|
160
|
|
(305)
|
|
|
|
|
|
|
|
|
|
Income Before Income
Tax
Benefit/(Provision)
|
|
10,060
|
|
3,491
|
|
19,379
|
|
126
|
|
|
|
|
|
|
|
|
|
Income tax
benefit/(provision)
|
|
10,946
|
|
(103)
|
|
9,368
|
|
(20)
|
|
|
|
|
|
|
|
|
|
Net Income
from
Continuing Operations
|
|
21,006
|
|
3,388
|
|
28,747
|
|
106
|
Gain on discontinued
operation, net
of provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
45
|
|
-
|
|
195
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
21,006
|
|
3,433
|
|
28,747
|
|
301
|
|
|
|
|
|
|
|
|
|
Basic
Earnings/(Loss) Per Share
|
|
|
|
|
|
|
|
|
Continuing
Operations
|
|
$
1.85
|
|
$
0.35
|
|
$
2.61
|
|
$
(0.96)
|
Discontinued
Operations
|
|
-
|
|
0.01
|
|
-
|
|
0.04
|
Basic Earnings/(Loss)
Per Share
|
|
$
1.85
|
|
$
0.36
|
|
$
2.61
|
|
$
(0.92)
|
|
|
|
|
|
|
|
|
|
Basic
Weighted-Average
Shares
Outstanding
|
|
|
|
|
|
|
|
|
|
11,287
|
|
9,506
|
|
10,941
|
|
5,071
|
|
|
|
|
|
|
|
|
|
Diluted
Earnings/(Loss) Per Share
|
|
|
|
|
|
|
|
|
Continuing
Operations
|
|
$
1.82
|
|
$
0.35
|
|
$
2.59
|
|
$
(0.96)
|
Discontinued
Operations
|
|
-
|
|
0.01
|
|
-
|
|
0.04
|
Diluted
Earnings/(Loss) Per Share
|
|
$
1.82
|
|
$
0.36
|
|
$
2.59
|
|
$
(0.92)
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
Shares Outstanding
|
|
|
|
|
|
|
|
|
|
11,476
|
|
9,511
|
|
11,053
|
|
5,071
|
|
|
|
|
|
|
|
|
|
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
December 31,
|
|
Year ended
December 31,
|
|
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
Operating
Income
|
|
$10,772
|
|
$3,460
|
|
$20,006
|
|
$898
|
|
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
1,282
|
|
437
|
|
3,878
|
|
1,110
|
|
|
|
|
|
|
|
|
|
Add
back
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
704
|
|
33
|
|
3,423
|
|
36
|
Merger-related expenses, not
already added
back
|
|
-
|
|
-
|
|
-
|
|
5,468
|
Adjusted EBITDA
|
|
$12,758
|
|
$3,930
|
|
$27,307
|
|
$7,512
|
|
|
|
|
|
|
|
|
|
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
December 31, 2014
|
|
Year ended
December 31, 2014
|
|
|
|
|
|
Net Income
|
|
$
21,006
|
|
$
28,747
|
|
|
|
|
|
Add back
|
|
|
|
|
Non-cash interest expense
|
|
560
|
|
560
|
Stock-based compensation
|
|
704
|
|
3,423
|
|
|
|
|
|
Adjusted Net Income
Used in Calculating Adjusted
non-GAAP Diluted Earnings Per Share
|
|
$
22,270
|
|
$
32,730
|
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
Shares
Outstanding
|
|
11,476
|
|
11,053
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
Diluted Earnings Per Share
|
|
$
1.94
|
|
$
2.96
|
|
|
|
|
|
ANI
Pharmaceuticals, Inc. and Subsidiary
|
Table 4: Pro Forma
Adjusted non-GAAP Diluted Earnings Per Share
Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
December 31, 2014
|
|
Year ended
December 31, 2014
|
|
|
|
|
|
Income Before Income
Tax Provision/(Benefit)
|
|
$
10,060
|
|
$
19,379
|
|
|
|
|
|
Subtract
|
|
|
|
|
Pro forma tax provision at
36%
|
|
3,622
|
|
6,976
|
|
|
|
|
|
Add back
|
|
|
|
|
Non-cash interest expense
|
|
560
|
|
560
|
Stock-based compensation
|
|
704
|
|
3,423
|
|
|
|
|
|
Adjusted Net Income
Used in Calculating Proforma
Adjusted non-GAAP Diluted Earnings Per
Share
|
|
$
7,702
|
|
$
16,386
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
Shares
Outstanding
|
|
11,476
|
|
11,053
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
Diluted Earnings Per Share
|
|
$
0.67
|
|
$
1.48
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-record-fourth-quarter-and-full-year-2014-financial-results-300038268.html
SOURCE ANI Pharmaceuticals, Inc.