05.03.2008 21:33:00
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Anika Therapeutics Reports Record Product Revenues for 2007
Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue
protection, healing and repair based on hyaluronic acid ("HA”)
technology, today reported record revenue for the year ending December
31, 2007. Anika also continued to strengthen its global position in
joint health therapies with the recent launch in Europe of ORTHOVISC®mini,
a HA osteoarthritis treatment specifically targeted for smaller joints,
and the commencement of a key U.S. clinical study of its
single-injection osteoarthritis product, MONOVISC™,
for the relief of knee pain.
Revenue
Anika reported product revenue of $7,916,000 for the fourth quarter of
2007, compared with $5,078,000 in the same period last year. For the
year ended December 31, 2007, product revenue increased to $26,905,000,
compared with $23,953,000 in full year 2006. The increase in product
revenue for the quarter was primarily attributable to strong domestic
and international sales of the Company’s
ORTHOVISC® product
line.
During the fourth quarter and year ended December 31, 2007, the Company
reported licensing, milestone and contract revenue of $1,711,000 and
$3,925,000, respectively. For the fourth quarter and year ended December
31, 2006, licensing, milestone and contract revenue was $811,000 and
$2,887,000, respectively. These increases reflect the impact of our
accounting for the termination of our previous ELEVESS™
contracts with Galderma.
Total revenue for the fourth quarter of 2007 was $9,627,000, compared
with $5,889,000 in the fourth quarter of 2006. For the year ended
December 31, 2007, total revenue was a record $30,830,000, compared with
$26,841,000 in 2006.
Product Gross Margin
Product gross margin for the fourth quarter of 2007 increased to 59%
from 40% in last year's fourth quarter. Product gross margin for the
year ended December 31, 2007 was 56% versus 54% for full year 2006. The
quarter and full year improvements in gross margins were due primarily
to strong domestic ORTHOVISC sales and favorable material prices.
Net Income
Net income for the fourth quarter of 2007 was $1,673,000, or $0.15 per
diluted share, compared with $1,047,000, or $0.09 per diluted share, for
the same period last year. Net income for the year ended December 31,
2007 was $6,035,000, or $0.53 per diluted share, compared with
$4,604,000, or $0.41 per diluted share, in 2006. The improvement in net
income in both the fourth quarter and full year periods was due to
increased product sales, milestones recognition, higher gross margins,
and a lower effective tax rate. The lower tax rate reflects higher state
investment tax credits as a result of Anika’s
ongoing investment in its new facility, as well as increased domestic
jobs creation deductions and tax credits related to R&D spending.
Other
Anika’s cash, cash equivalents and short-term
investments at December 31, 2007 were $39,406,000 compared with
$47,167,000 at December 31, 2006. The decrease reflects the Company’s
investment in its new facility to increase capacity, and upgrade its new
product development capabilities.
Management Commentary "This has been a year of tremendous progress
for Anika,” said Charles H. Sherwood, Ph.D.,
Anika’s president and chief executive
officer. "Revenue for ORTHOVISC increased
more than 110 percent in the fourth quarter and finished strongly for
the year thanks to demand in the U.S. and in international markets
during the second half of the year. We received European CE Mark
approval for our new MONOVISC single-injection osteoarthritis product
based on our proprietary cross-linking technology, and began enrolling
patients in a key U.S. clinical study of that product for the relief of
knee pain. In addition, we recently completed the European launch of
ORTHOVISC mini, our hyaluronic
acid-based osteoarthritis treatment specifically targeted to treat
smaller joints. Operationally, we expanded our R&D headcount and made
significant additions to our technical and scientific staffs. And in
November, we completed Phase 1 of our new facility in Bedford and moved
in our R&D, regulatory, marketing and administration associates.” "We have focused considerable attention on
securing a distribution partner for ELEVESS, our HA-based soft-tissue
filler for facial wrinkles and scar remediation that incorporates
lidocaine,” continued Sherwood. "Interest
is high among the potential partners we have met with and we are
pursuing this effort vigorously. We are also in the midst of a marketing
program targeting the dermatology community with detailed information,
samples, and training on ELEVESS, and we’re
pleased to report significant interest on the part of both doctors and
patients.” "We believe that we have a robust pipeline of
products for our proprietary HA technology that we can begin to leverage
worldwide,” continued Sherwood. "We
look forward to introducing MONOVISC in Europe by mid year 2008 and
capitalizing on the recent launch of ORTHOVISC mini
in that region. With the progress we have made in pursuing a partner for
ELEVESS, we anticipate launching the product mid year. Additionally, we
expect that our new facility will play an important role in improving
the efficiency of our business and R&D processes in the coming year. We
look forward to 2008 with confidence in our product portfolio and expect
this to be a good year of revenue growth for Anika.” Conference Call Information
Anika will hold a conference call to discuss its financial results,
business highlights and outlook on Thursday, March 6, 2008, 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 888-680-0893 (International
callers dial 617-213-4859) and use the passcode 88280313. Please call
approximately 10 minutes before the starting time and reference Anika
Therapeutics. In addition, the conference call will be available to
interested parties through a live audio Internet broadcast at www.anikatherapeutics.com.
The 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 include ORTHOVISC®,
a treatment for osteoarthritis of the knee available internationally and
marketed in the U.S. by DePuy Mitek; HYVISC®,
a treatment for equine osteoarthritis marketed in the U.S. by Boehringer
Ingelheim Vetmedica, Inc.; the ELEVESS™
family of aesthetic dermatology products for facial wrinkles, scar
remediation and lip augmentation; AMVISC®,
AMVISC® Plus,
STAARVISC™-II and Shellgel™
injectable viscoelastic HA products for ophthalmic surgery; INCERT®,
an HA-based anti-adhesive for surgical applications; ORTHOVISC® mini a treatment for osteoarthritis targeting small joints
and available in Europe, MONOVISC™ a single-injection osteoarthritis product based on our proprietary
cross-linking technology and scheduled to launch in Europe mid year 2008, and next generation products for joint health and aesthetic
dermatology based on the Company’s
proprietary, chemically modified HA.
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 and Section 21E of the
Securities Exchange Act of 1934, including, without limitation,
statements that may be identified by words such as "expectations,"
"remains," "focus," "expected," "prospective," "expanding," "building,"
"continue," "progress," "plan,”
"efforts," "hope," "believe," "objectives," "opportunities," "will,"
"seek," "expect”
and other expressions which are predictions of or indicate future events
and trends and which do not constitute historical matters identify
forward-looking statements. These statements also include: (i)
the company's expectations regarding its cosmetic dermatology product,
ELEVESS™,
(ii) product gross margin (iii) the company’s
expectations concerning its MONOVISC product, (iv) statements concerning
ORTHOVISC mini, and (v) statements concerning revenue growth . 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 license ELEVESS to a new distribution partner on terms
favorable to the company, if at all; (ii) 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 and/or FDA approval, and/or receive FDA or other
regulatory approvals of its products, or that such approvals will not be
obtained in a timely manner or without the need for additional clinical
trials; (iii) 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; (vi) the cost
effectiveness and efficiency of our manufacturing operations and
production planning; (v) 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 (vi) future
determinations by the company to allocate resources to products and in
directions not presently contemplated or (vii) the company’s
ability to launch MONOVISC in Europe, if at all. Any delay in
receiving any regulatory approvals may adversely affect the company's
competitive position. Even if regulatory approvals are obtained,
there is a risk that meaningful sales of the products may not be
achieved. There is also a risk that (i) the company's existing
distributors (including its distributor in Turkey) or customers will not
continue to place orders at historical levels or that any of them will
seek to modify or terminate existing arrangements, (ii) the company's
efforts to enter into long-term marketing and distribution arrangements,
including with new international distributors for ORTHOVISC and
MONOVISC, will not be successful, (iii) new distribution arrangements
will not result in meaningful sales of the company's products, (iv) the
company will be unable to achieve performance and sales threshold
milestones in its distribution agreements, (v) competitive products will
adversely impact the company's product sales, (vi) the estimated size(s)
of the markets which the company has targeted its products will fail to
be achieved, (vii) lack of adequate coverage and reimbursement provided
by governments and other third party payers for our products and
services, including non-reimbursement of ORTHOVISC in Turkey, could have
a material adverse effect on our results of operations, or (viii)
increased sales of the company's products, including HYVISC®,
ORTHOVISC , or its ophthalmic products, will not continue or sales will
decrease or not reach historical sales levels, or even if such increases
occur that such increases will improve gross margins, any of which may
have a material adverse effect on the company's business and operations. There can be no assurance that the company will license ELEVESS to a
new distribution partner on terms favorable to the company or at all. 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 each of the company's Annual Report on Form
10-K for the year ended December 31, 2006 and on Form 10-Q for the
period ended September 30, 2007, as well as those described in the
company's other press releases and SEC filings. Anika Therapeutics, Inc. and Subsidiary Consolidated Statements of Operations (unaudited)
Quarter Ended Twelve Months Ended December 31, December 31, 2007
2006 2007
2006
Product revenue
$ 7,915,967
$ 5,077,561
$ 26,905,100
$ 23,953,285
Licensing, milestone and contract revenue
1,710,866
811,395
3,924,721
2,887,329
Total revenue
9,626,833
5,888,956
30,829,821
26,840,614
Operating expenses:
Cost of product revenue
3,225,979
3,054,111
11,880,989
11,117,861
Research & development
1,395,402
504,477
4,364,620
3,616,435
Selling, general & administrative
2,884,634
1,459,853
7,996,781
6,678,845
Total operating expenses
7,506,015
5,018,441
24,242,390
21,413,141
Income from operations
2,120,818
870,515
6,587,431
5,427,473
Interest income, net
408,041
580,674
2,100,663
2,100,749
Income before income taxes
2,528,859
1,451,189
8,688,094
7,528,222
Provision for income taxes
855,463
404,427
2,652,840
2,924,006
Net income
$ 1,673,396
$ 1,046,762
$ 6,035,254
$ 4,604,216
Basic net income per share:
Net income
$ 0.15
$ 0.10
$ 0.55
$ 0.43
Basic weighted average common shares outstanding
11,177,521
10,745,819
11,059,582
10,639,028
Diluted net income per share:
Net income
$ 0.15
$ 0.09
$ 0.53
$ 0.41
Diluted weighted average common shares outstanding
11,511,862
11,196,213
11,453,600
11,155,249
Anika Therapeutics, Inc. and Subsidiary Consolidated Balance Sheets
December 31, December 31, 2007 2006 ASSETS
Current assets:
Cash and cash equivalents
$ 35,903,569
$ 47,167,432
Short-term investment
3,501,974
—
Accounts receivable, net
5,795,973
3,509,508
Inventories
4,390,118
5,395,596
Current portion deferred income taxes
1,657,007
1,312,901
Prepaid expenses and other
1,194,081
220,445
Total current assets
52,442,722
57,605,882
Property and equipment, at cost
28,101,422
13,255,240
Less: accumulated depreciation
(8,731,706)
(10,237,232)
19,369,716
3,018,008
Long-term deposits and other
433,081
193,050
Intangible asset, net
995,098
—
Deferred income taxes
6,256,067
7,296,689
Total Assets
$ 79,496,684
$ 68,113,629
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable
$ 4,866,619
$ 965,180
Accrued expenses
2,760,010
1,573,835
Deferred revenue, current
2,806,778
2,905,099
Income taxes payable
203,954
17,253
Other long-term liabilities
398,365
64,525
Long-term deferred revenue
13,500,001
17,099,712
Total liabilities
24,535,727
22,625,604
Stockholders’ equity
Preferred stock
— —
Common stock
112,233
107,727
Additional paid-in-capital
40,695,940
37,262,768
Retained earnings
14,152,784
8,117,530
Total stockholders’ equity
54,960,957
45,488,025
Total Liabilities and Stockholders’ Equity
$ 79,496,684
$ 68,113,629
Anika Therapeutics, Inc. and Subsidiary Supplemental Financial Data - (unaudited)
Product Gross Margin and Revenue by Product Line
Quarter Ended Twelve Months Ended December 31, December 31, 2007 % Ttl 2006 % Ttl 2007 % Ttl 2006 % Ttl
Ophthalmic Products
$ 2,448,545
31%
$ 2,316,157
46%
$ 10,517,156
39%
$ 10,748,765
45%
ORTHOVISC
4,707,742
59%
2,221,897
44%
13,602,493
51%
11,340,433
47%
HYVISC
688,028
9%
522,077
10%
2,370,898
9%
1,820,617
8%
Other
71,652
1%
17,430
0%
414,553
1%
43,470
0%
$ 7,915,967
100%
$ 5,077,561
100%
$ 26,905,100
100%
$ 23,953,285
100%
Product gross profit
$ 4,689,988
$ 2,023,450
$ 15,024,111
$ 12,835,424
Product gross margin
59%
40%
56%
54%
Product Revenue by Geography
Quarter Ended Twelve Months Ended December 31, December 31, 2007 % Ttl 2006 % Ttl 2007 % Ttl 2006 % Ttl
Domestic
$ 5,858,105
74%
$ 3,873,984
76%
$ 20,034,764
74%
$ 15,011,369
63%
International
2,057,862
26%
1,203,577
24%
6,870,336
26%
8,941,916
37%
$ 7,915,967
100%
$ 5,077,561
100%
$ 26,905,100
100%
$ 23,953,285
100%
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