Anika
Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing, and repair, based on hyaluronic
acid (“HA”) technology, today reported financial results for the
quarter ended June 30, 2012.
Revenue
For the second quarter of 2012, Anika’s total revenue increased 22% to
$19.6 million, from $16.1 million in the second quarter last year. This
growth was primarily driven by higher shipments of Anika’s ophthalmic
products, as well as strong domestic and international sales of the
company’s flagship product, Orthovisc®.
For the six-month period ended June 30, 2012, total revenue increased
22% to $34.0 million, from $27.9 million in the same period last year.
Product Gross Margin
Driven by higher production volume, product gross margin for the second
quarter of 2012 increased to 57.2%, from 56.8% in the second quarter
last year.
For the six-month period ended June 30, 2012, product gross margin
increased to 55.4%, from 53.7% in the first six months of 2011.
Operating and Net Income
Operating income for the second quarter of 2012 increased to $6.1
million, from $3.7 million in the same period in 2011. Net income rose
to $3.7 million, or $0.26 per diluted share, from $2.3 million, or $0.17
per diluted share, in the second quarter a year earlier. The company’s
improved profitability was primarily driven by a combination of revenue
growth, higher gross margin, and lower operating expenses. The company’s
effective tax rate for the second quarter of 2012 was 38.6%, compared
with 37.2% for the second quarter of 2011.
For the six-month period ended June 30, 2012, net income rose to $5.6
million, or $0.39 per diluted share, from $2.6 million, or $0.19 per
diluted share, in the first six months of 2011.
Operating Expenses
Research and development expenses for the second quarter of 2012
decreased to $1.3 million, from $1.6 million in the second quarter last
year. Anika continues to expect R&D expense to increase modestly in the
second half of 2012 on a year-over-year basis due to the anticipated
initiation of preclinical and clinical studies.
Selling, general and administrative expenses in the second quarter of
2012 decreased to $4.1 million, from $4.2 million in the second quarter
of 2011. The decrease was primarily due to placing in service the
remainder of the company’s Bedford manufacturing facility. Prior to the
first quarter of 2012, the previously unoccupied space was expensed to
SG&A.
Cash and Cash Equivalents
Anika’s cash and cash equivalents at June 30, 2012 were $37.9 million,
compared with $34.0 million at March 31, 2012. The increase was
primarily the result of higher profitability and collections on accounts
receivable.
Management Commentary
“Anika concluded the first half of 2012 with all-time record quarterly
revenue and record second-quarter earnings, while making solid progress
toward key strategic goals,” said Charles H. Sherwood, Ph.D., president
and chief executive officer. “Total revenue was up 22% from the second
quarter last year, driven primarily by strong sales of our flagship
product, Orthovisc®, both domestically and internationally
and increased shipments in our Ophthalmic franchise. This growth was
somewhat offset by year-over-year declines in sales of Monovisc®
internationally, as well as slower sales of our products by Anika S.r.l.”
“We made solid operational progress in the second quarter,” said
Sherwood. “We closed Anika’s facility in Woburn, Mass. and consolidated
all of our manufacturing at our new facility in Bedford, Mass., by the
end of the quarter as planned. We had a positive meeting with the FDA
regarding our PMA application for Monovisc, and moved closer to starting
patient enrollment in clinical trials for two key pipeline products.”
“Anika is starting the second half of 2012 with strong forward
momentum,” Sherwood said. “Completing the manufacturing consolidation in
Bedford allows us to strengthen our focus on our product pipeline and
distribution network to drive top-line growth.”
Conference Call Information
Anika will hold a conference call to discuss its financial results,
business highlights and outlook tomorrow, Thursday, August 2, 2012 at
9:00 a.m. ET. In addition, the company will answer questions concerning
business and financial developments and trends, and other business and
financial matters affecting the company, some of the responses to which
may contain information that has not been previously disclosed.
To listen to the conference call, dial 866-783-2144 (international
callers dial 857-350-1603) and use the passcode 77982694. Please call
approximately 10 minutes before the starting time and reference Anika
Therapeutics. In addition, the conference call will be available through
a live audio webcast in the “Investor
Relations” section of the Anika Therapeutics website, www.anikatherapeutics.com.
An accompanying slide presentation also can be accessed via the Anika
Therapeutics website. The conference call will be archived and
accessible on the same website shortly after the conclusion of the call.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika
Therapeutics, Inc.develops,
manufactures and commercializes therapeutic products for tissue
protection, healing, and repair. These products are based on hyaluronic
acid (HA), a naturally occurring, biocompatible polymer found
throughout the body. Anika’s products range from orthopedic/joint health
solutions led by Orthovisc,
a treatment for osteoarthritis of the knee, to surgical aids in the ophthalmic
and anti-adhesion
fields. The company also offersaesthetic
dermal fillers for the correction of facial wrinkles. Anika’s
Italian subsidiary, Anika S.r.l., provides complementary HA products in
orthopedic/joint health and anti-adhesion, as well as therapeutics in
new areas such as advanced wound treatment and ear, nose and throat
care. Anika S.r.l.’s regenerative tissue technology advances Anika’s
vision to offer therapeutic products that go beyond pain relief to
protect and restore damaged tissue.
The statements made in this press release which are not statements of
historical fact are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended.These
statements include, but are not limited to, those relating to: (i) FDA
review of our PMA application for Monovisc, and (ii) expectations
regarding research and development spending in future quarters. These
statements are based upon the current beliefs and expectations of the
company's management and are subject to significant risks, uncertainties
and other factors.The company's actual results could differ
materially from any anticipated future results, performance or
achievements described in the forward-looking statements as a result of
a number of factors including (i) the company's ability to successfully
commence and/or complete clinical trials of its products on a timely
basis or at all, obtain clinical data to support a pre-market approval
application or timely file and receive FDA or other regulatory approvals
or clearances of its products and Bedford facility, or that such
approvals will not be obtained in a timely manner or without the need
for additional clinical trials, other testing or regulatory submissions,
as applicable; (ii) the company's research and product development
efforts and their relative success, including whether the company has
any meaningful sales of any new products resulting from such efforts;
(iii) the cost effectiveness and efficiency of our clinical studies,
manufacturing operations and production planning; (iv) the strength of
the economies in which the company operates or will be operating, as
well as the political stability of any of those geographic areas; (v)
future determinations by the company to allocate resources to products
and in directions not presently contemplated, (vi) the company’s ability
to launch Monovisc in the U.S., if at all; (vii) the company’s ability
to successfully resolve its appeal hearing regarding the FDA’s
non-approvable letter for Monovisc, and the timing and results of such
review; (viii) the company’s ability to provide an adequate and timely
supply of its ophthalmic, Orthovisc and other products to its customers,
(ix) our ability to successfully manage and turnaround Anika S.r.l.’s
business, and (x) the company’s ability to achieve its stated growth
targets.Certain other factors that might cause the company's
actual results to differ materially from those in the forward-looking
statements include those set forth under the headings "Business," "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in the company's Annual Report on
Form 10-K for the year ended December 31, 2011, as well as those
described in the company's other press releases and SEC filings.
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2012
2011
2012
2011
Product revenue
$
18,882,277
$
15,414,681
$
32,495,605
$
26,474,840
Licensing, milestone and contract revenue
742,492
726,171
1,489,824
1,403,691
Total revenue
19,624,769
16,140,852
33,985,429
27,878,531
Operating expenses:
Cost of product revenue
8,084,226
6,655,804
14,497,707
12,260,366
Research & development
1,298,170
1,574,155
2,831,273
3,106,820
Selling, general & administrative
4,108,503
4,233,316
7,459,519
8,277,090
Total operating expenses
13,490,899
12,463,275
24,788,499
23,644,276
Income from operations
6,133,870
3,677,577
9,196,930
4,234,255
Interest income (expense), net
(49,129
)
(45,281
)
(100,332
)
(86,202
)
Income before income taxes
6,084,741
3,632,296
9,096,598
4,148,053
Provision for income taxes
2,347,873
1,349,655
3,447,611
1,541,001
Net income
$
3,736,868
$
2,282,641
$
5,648,987
$
2,607,052
Basic net income per share:
Net income
$
0.28
$
0.18
$
0.43
$
0.21
Basic weighted average common shares outstanding
13,262,023
12,725,216
13,212,424
12,707,143
Diluted net income per share:
Net income
$
0.26
$
0.17
$
0.39
$
0.19
Diluted weighted average common shares outstanding
14,443,794
13,739,836
14,302,439
13,741,337
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)
June 30,
December 31,
ASSETS
2012
2011
Current assets:
Cash and cash equivalents
$
37,909,608
$
35,777,222
Accounts receivable, net of reserves of $457,300 and $334,473 at June
30, 2012 and December 31, 2011, respectively
17,694,097
17,307,786
Inventories
10,776,788
7,302,483
Current portion deferred income taxes
2,708,477
1,918,926
Prepaid expenses and other
510,045
1,831,127
Total current assets
69,599,015
64,137,544
Property and equipment, at cost
51,920,745
50,850,630
Less: accumulated depreciation
(15,499,638
)
(14,380,752
)
36,421,107
36,469,878
Long-term deposits and other
221,485
205,042
Intangible assets, net
21,506,474
23,148,563
Goodwill
8,627,518
8,883,407
Total Assets
$
136,375,599
$
132,844,434
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
3,941,436
$
4,299,680
Accrued expenses
4,275,574
5,321,594
Deferred revenue
2,866,667
2,866,667
Current portion of long-term debt
1,600,000
1,600,000
Income taxes payable
2,530,386
450,482
Total current liabilities
15,214,063
14,538,423
Other long-term liabilities
1,535,140
1,548,652
Long-term deferred revenue
3,586,106
5,019,440
Deferred tax liability
6,491,837
7,375,141
Long-term debt
8,800,000
9,600,000
Commitments and contingencies
-
-
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares
issued and outstanding at June 30, 2012 and December 31,
2011, respectively
-
-
Common stock, $.01 par value; 30,000,000 shares authorized, 13,765,996
and 13,630,607 shares issued and outstanding at
June 30, 2012 and December 31, 2011, respectively
137,659
136,305
Additional paid-in-capital
64,620,510
63,441,433
Accumulated currency translation adjustment
(3,910,924
)
(3,067,181
)
Retained earnings
39,901,208
34,252,221
Total stockholders’ equity
100,748,453
94,762,778
Total Liabilities and Stockholders’ Equity
$
136,375,599
$
132,844,434
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
Revenue by Product Line and Product Gross Margin
Three Months Ended June 30,
2012
2011
%
Orthobiologics
$
10,903,364
$
9,763,597
12
%
Dermal
155,735
799,605
-81
%
Ophthalmic
5,299,732
2,584,820
105
%
Surgical
1,464,505
1,566,026
-6
%
Veterinary
1,058,941
700,633
51
%
Total Product Revenue
$
18,882,277
$
15,414,681
22
%
Product gross profit
$
10,798,051
$
8,758,877
Product gross margin
57.2
%
56.8
%
Six Months Ended June 30,
2012
2011
%
Orthobiologics
$
21,020,209
$
17,799,893
18
%
Dermal
657,051
1,388,759
-53
%
Ophthalmic
6,623,726
3,482,629
90
%
Surgical
2,448,133
2,679,755
-9
%
Veterinary
1,746,486
1,123,804
55
%
Total Product Revenue
$
32,495,605
$
26,474,840
23
%
Product gross profit
$
17,997,898
$
14,214,474
Product gross margin
55.4
%
53.7
%
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
Revenue by Geographic Region
Three Months Ended June 30,
2012
2011
%
Geographic Location:
United States
$
16,011,667
$
11,594,988
38
%
Europe
1,521,552
2,604,021
-42
%
Other
1,349,058
1,215,672
11
%
Total
$
18,882,277
$
15,414,681
22
%
Six Months Ended June 30,
2012
2011
%
Geographic Location:
United States
$
26,401,712
$
19,938,102
32
%
Europe
3,677,281
4,637,219
-21
%
Other
2,416,612
1,899,519
27
%
Total
$
32,495,605
$
26,474,840
23
%
Contacts:
Anika Therapeutics, Inc. Charles H. Sherwood, Ph.D., 781-457-9000 CEO or Kevin
W. Quinlan, 781-457-9000 CFO