BAUDETTE, Minn., May 5, 2016 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today reported
financial results for the three months ended March 31, 2016, and reaffirmed its financial
guidance for 2016 as updated on April 4,
2016. The Company will host its earnings conference call
this morning, May 5, 2016, at
10:30 AM ET. Investors and other
interested parties can join the call by dialing (844) 295-8236. The
conference ID is 93601942.
Arthur S. Przybyl, President and
CEO, stated,
"ANI had a strong first quarter.
Thus far in 2016, we have closed three acquisitions and received
two FDA approvals. We anticipate launching a total of seven
products in the second quarter of 2016, three of which were
launched in April.
We began the year with the
completion of our acquisition of the Corticotropin NDAs on
January 4th, followed
closely by the January
28th acquisition of the exclusive rights to
distribute the authorized generic of Lipofen®, as well as 1% and
2.5% hydrocortisone rectal cream. We launched the hydrocortisone
rectal cream products in April and are currently launching the
authorized generic of Lipofen® in our own label. On April 1st, we completed our
acquisition of the Inderal® NDA, which will be accretive to revenue
and adjusted non-GAAP EBITDA starting in the second quarter and is
included in our guidance."
ANI's Updated Guidance for the Full Year 2016
ANI's estimates are based on projected results for the twelve
months ending December 31, 2016 and
reflect management's current beliefs about product pricing,
prescription trends, inventory levels, cost of sales, operating
costs, and the anticipated timing of future product launches and
events.
- Net revenues for 2016 to be between $119 million and $134 million.
- Adjusted non-GAAP EBITDA(a), to be between
$55 million and
$63 million.
- Adjusted non-GAAP net income per diluted share(b),
to be between $3.54 and $3.91,
assuming 11,489 thousand weighted average shares outstanding.
- Reported (US GAAP) diluted EPS to be between $0.30 and $0.65.
ANI's 2016 guidance is based on certain assumptions
including:
- EEMT market share is anticipated to remain stable at
approximately 50%.
- Cost of sales(c) of approximately 35%.
- Operating expenses(d), inclusive of research and
development costs, of between $24 and $24.5
million.
- Depreciation and amortization expense of approximately
$22.6 million.
- Interest expense of approximately $11.4
million.
- Current tax provision of between $11.5
and $16.5 million.
(a) See Table 2 for US GAAP reconciliation.
(b) See Table 3 for US GAAP reconciliation.
(c) Exclusive of depreciation and amortization.
(d) Excludes non-cash stock compensation expense.
New Product
Introductions
|
Product
|
|
Total Annual
Market Size(e)
|
|
Estimated
Launch
|
|
FDA Approvals
Required
|
Inderal®
LA
|
|
$23M
|
|
Launched April
2016
|
|
Approved
|
Propranolol
ER
|
|
$165M
|
|
Launched April
2016
|
|
Approved
|
Hydrocortisone rectal
cream, 1% and 2.5%
|
|
$84M
|
|
Launched April
2016
|
|
Approved
|
Fenofibrate 50mg and
150mg
|
|
$24M
|
|
May 2016
|
|
Approved
|
Authorized generic
product
|
|
$21M
|
|
May 2016
|
|
Approved
|
Oxycodone
capsules
|
|
$7.5M
|
|
June 2016
|
|
Approved
|
Anti-cancer
drug
|
|
Undisclosed
|
|
June 2016
|
|
ANDA
|
Donepezil
|
|
$41M
|
|
Q3 2016
|
|
Approved
|
Anti-Infective
|
|
$75M
|
|
Q3 2016
|
|
CBE-30
|
Three IDT
products
|
|
$86M
|
|
Q3 2016/Q4
2016
|
|
CBE-30s
|
Three additional C-II
products (TADs(f) 1/2/2017 and
2/15/2017)
|
|
$39M
|
|
Q1 2017
|
|
ANDAs
|
(e) Per IMS Health
(f) FDA's Target Action Date, per FDA communications
Year-to-Date Highlights Include:
- First quarter net revenues of $20.6
million, an increase of 9% as compared to $18.8 million for the same period in 2015.
- First quarter adjusted non-GAAP EBITDA of $11.4 million, a slight decrease of 1% as
compared to $11.5 million for the
same period in 2015.
- First quarter operating income of $5.7
million, a decrease of 41% as compared to $9.6 million for the same period in 2015.
- First quarter adjusted non-GAAP diluted earnings per share of
$0.76.
- First quarter diluted earnings per share of $0.12.
- Appointment of Stephen P. Carey
as Vice President and Chief Financial Officer.
- Acquired NDAs for Corticotropin and Corticotropin-Zinc.
- Acquired exclusive rights to distribute an authorized generic
of Lipofen® and 1% and 2.5% hydrocortisone rectal cream.
- Acquired the product rights for Inderal® LA.
- Received ANDA approval for Donepezil tablets (via Dexcel
partnership).
- Received ANDA approval for Oxycodone capsules.
- Launched 1% and 2.5% hydrocortisone rectal cream.
- Launched Inderal® LA and Propranolol ER.
- Repurchased 65 thousand shares of ANIP common stock for
$2.5 million.
First Quarter
Results
|
|
Net
Revenues
(in
thousands)
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
Change
|
|
%
Change
|
Generic
pharmaceutical products
|
|
$
|
13,252
|
|
$
|
12,256
|
|
$
|
996
|
|
8%
|
Branded
pharmaceutical products
|
|
|
5,596
|
|
|
4,272
|
|
|
1,324
|
|
31%
|
Contract
manufacturing
|
|
|
1,384
|
|
|
1,205
|
|
|
179
|
|
15%
|
Contract services and
other income
|
|
|
323
|
|
|
1,066
|
|
|
(743)
|
|
(70)%
|
Total net
revenues
|
|
$
|
20,555
|
|
$
|
18,799
|
|
$
|
1,756
|
|
9%
|
For the three months ended March 31,
2016, ANI reported net revenues of $20.6 million, an increase of 9% from
$18.8 million in the prior year
period, due to the following factors:
- Revenues from sales of generic pharmaceuticals increased 8%, to
$13.3 million from $12.3 million in the prior period, primarily due
to, sales of Oxycodone oral solution, Vancomycin, Nimodipine, and
Flecainide, all of which were launched in Q4 2015, as well as full
quarter sales of Etodolac, and Propafenone, which launched in Q1
2015.
- Revenues from sales of branded pharmaceuticals increased 31%,
to $5.6 million from $4.3 million in the prior period, primarily as a
result of higher sales of Lithobid and Vancocin, partially offset
by lower unit sales of Reglan and increased Medicaid utilization
for Lithobid and Vancocin.
- Contract manufacturing revenue increased by 15% to $1.4 million from $1.2
million in the prior year period, primarily as a result of
the timing of customer orders.
- Contract services and other income decreased by 70%, to
$0.3 million from
$1.1 million, primarily because the
Company launched an authorized generic for Vancocin under its own
label, which replaced the authorized generic product previously on
the market, partially offset by royalty income on sales of the
authorized generic of Lipofen®, which is anticipated to launch
under the ANI label in the second quarter.
Cost of sales increased as a percentage of net revenues to 17%
from 15%, primarily as a result of increased sales of products with
profit-sharing arrangements.
Research and development costs increased to $1.0 million for the three months
ended March 31, 2016, from
$0.4 million in the prior year
period. The increase was due to timing of work on development
projects. Major development projects include the ANDAs acquired in
2014 and 2015, as well as collaborations with partners.
Selling, general, and administrative expenses increased to
$5.9 million for the
three months ended March 31, 2016,
from $4.8 million in the prior year
period. The increase was primarily due to increased personnel and
compensation costs to support growth of the business.
Net income was $1.3 million for the three months
ended March 31, 2016, as compared to
net income of $4.4 million in the
prior year period, primarily due to a $3.3
million increase in depreciation and amortization in the
current period. Diluted earnings per share for the three months
ended March 31, 2016 was $0.12, based on 11,489 thousand diluted shares
outstanding, as compared to diluted earnings per share of
$0.38 in the prior year period.
Adjusted non-GAAP net income per diluted share was $0.76, as compared to adjusted non-GAAP net
income per diluted share of $0.71 in
the prior year period. For a reconciliation of adjusted non-GAAP
net income per diluted share to GAAP net income, please see Table
3.
Selected Balance
Sheet Data
|
|
|
(in
thousands)
|
|
|
|
March 31,
2016
|
December 31,
2015
|
Cash
|
$
77,747
|
$
154,684
|
Accounts receivable,
net
|
$
22,481
|
$
21,932
|
Inventory,
net
|
$
13,922
|
$
13,387
|
Current
assets
|
$
116,552
|
$
192,583
|
Current
liabilities
|
$
16,211
|
$
11,756
|
ANI generated $11.0 million of
positive cash flows from operations in the three months ended
March 31, 2016. Also in the first
quarter, ANI purchased from Merck the NDAs for Corticotropin and
Corticotropin-Zinc for $75.0 million
and a percentage of future net sales on products sold under the
NDAs. ANI also purchased from H2-Pharma, LLC the exclusive U.S.
distribution rights for three products, as well as an early stage
development project for a generic injectable drug product, for
$8.8 million in cash and the
assumption of an accrued royalty of $1.2
million. As a result of the net effect of these sources and
uses of cash, ANI had $77.7 million
of cash at March 31, 2016. On
April 1, 2016, ANI purchased from
Cranford Pharmaceuticals the rights, title, and interest in the NDA
for Inderal® LA, as well as certain documentation, trademark
rights, and finished goods for $60.0
million upon closing and milestone payments based on future
gross profits from sales of products under the NDA. The
$60.0 million was paid from cash on
hand. At closing, ANI also transferred $5.0
million to an escrow account to secure future milestone
payments.
Net accounts receivable increased from $21.9 million to $22.5
million. ANI's net inventory increased from $13.4 million to $13.9
million, as a direct result of raw materials acquired for
key products. ANI's total current assets decreased to $116.6 million at March
31, 2016, from $192.6 million
at December 31, 2015.
ANI Product Development Pipeline
Overview
ANI's pipeline consists of 81 products, 55 of which were
acquired. Of these acquired products, ANI expects that 48 can be
commercialized based on either CBE-30s or prior approval
supplements filed with the FDA.
Product Development
ANI expects to file two prior approval supplements and two
CBE-30s in 2016. A table summarizing ANI's pipeline of products is
below:
Products
|
|
ANI
|
|
Partnered
|
|
Total
|
At FDA
|
|
3
|
|
1
|
|
4
|
Development
|
|
3
|
|
19
|
|
22
|
Acquired
Products
|
|
55
|
|
0
|
|
55
|
ANI's product development pipeline includes extended-release
products, controlled substances, anti-cancers, oral solutions,
suspensions, and solid dosage forms. These 81 generic products
address a total annual market size of $4.1
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 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 operating income/(loss),
excluding depreciation, amortization, the excess of fair value over
cost of acquired inventory, and stock-based compensation 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 2.
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 non-cash stock-based compensation, non-cash
interest expense, depreciation amortization, and deferred tax
expenses and benefits. Management uses adjusted non-GAAP net income
when analyzing Company performance.
Adjusted non-GAAP net income is defined as net income/(loss),
plus tax expense, the excess of fair value over cost of acquired
inventory, stock-based compensation expense, non-cash interest
expense, depreciation and amortization expense, less the current
portion of the tax provision. 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 3.
Adjusted non-GAAP Net Income per Diluted Share
ANI's management considers adjusted non-GAAP net income per
diluted 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, non-cash interest expense, depreciation,
amortization, and deferred tax expenses and benefits. Management
uses adjusted non-GAAP net income per diluted share when analyzing
Company performance.
Adjusted non-GAAP net income per diluted share is defined as
adjusted non-GAAP net income, as defined above, divided by the
diluted weighted average shares outstanding during the period.
Adjusted non-GAAP net income per diluted 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 net
income per diluted 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 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
March 31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Net
Revenues
|
|
$
20,555
|
|
$
18,799
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
Cost of
sales (excl. depreciation
|
|
|
|
|
and
amortization)
|
|
3,410
|
|
2,751
|
Research and
development
|
|
966
|
|
403
|
Selling, general, and
administrative
|
|
5,904
|
|
4,751
|
Depreciation and
amortization
|
|
4,609
|
|
1,327
|
|
|
|
|
|
Total Operating
Expenses
|
|
14,889
|
|
9,232
|
|
|
|
|
|
Operating Income
|
|
5,666
|
|
9,567
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
Interest
expense, net
|
|
(2,782)
|
|
(2,725)
|
Other
income, net
|
|
2
|
|
68
|
|
|
|
|
|
Income Before
Provision for Income Taxes
|
|
2,886
|
|
6,910
|
|
|
|
|
|
Provision for Income
Taxes
|
|
(1,540)
|
|
(2,541)
|
|
|
|
|
|
Net Income
|
|
$
1,346
|
|
$
4,369
|
|
|
|
|
|
Basic Earnings Per
Share
|
|
|
|
|
Basic Earnings Per
Share
|
|
$
0.12
|
|
$
0.38
|
Diluted Earnings Per
Share
|
|
$
0.12
|
|
$
0.38
|
|
|
|
|
|
Basic
Weighted-Average Shares Outstanding
|
|
11,395
|
|
11,326
|
Diluted
Weighted-Average Shares Outstanding
|
|
11,489
|
|
11,562
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 2: Adjusted
non-GAAP EBITDA Calculation and US GAAP to Non-GAAP
Reconciliation
|
(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
Operating
Income
|
|
$
5,666
|
|
$
9,567
|
|
|
|
|
|
|
|
Add back
|
|
|
|
|
|
Depreciation and amortization
|
|
4,609
|
|
1,327
|
|
|
|
|
|
|
|
Add
back
|
|
|
|
|
|
Stock-based compensation
|
|
1,105
|
|
568
|
|
Adjusted non-GAAP EBITDA
|
|
$
11,380
|
|
$
11,462
|
|
ANI
Pharmaceuticals, Inc. and Subsidiaries
|
Table 3: Adjusted
non-GAAP Net Income and Adjusted non-GAAP Net Income per Diluted
Share Reconciliation
|
(unaudited, in
thousands, except per share amounts)
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
Net Income
|
|
$
1,346
|
|
4,369
|
|
|
|
|
|
Add back
|
|
|
|
|
Tax provision
|
|
1,540
|
|
2,541
|
Depreciation and amortization expense
|
|
4,609
|
|
1,327
|
Non-cash interest expense
|
|
1,725
|
|
1,683
|
Stock-based compensation
|
|
1,105
|
|
568
|
Excess of Fair Value over Cost of Acquired Inventory
|
|
-
|
|
-
|
Less
|
|
|
|
|
Current portion of tax provision
|
|
(1,620)
|
|
(2,238)
|
|
|
|
|
|
Adjusted non-GAAP Net
Income
|
|
$
8,705
|
|
$
8,250
|
|
|
|
|
|
|
|
|
|
|
Diluted
Weighted-Average
|
|
|
|
|
Shares
Outstanding
|
|
11,489
|
|
11,562
|
|
|
|
|
|
Adjusted
non-GAAP
|
|
|
|
|
Net Income Per Diluted Share
|
|
$
0.76
|
|
$
0.71
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/ani-pharmaceuticals-reports-first-quarter-results-and-year-to-date-2016-highlights-and-reaffirms-updated-guidance-300263049.html
SOURCE ANI Pharmaceuticals, Inc.