Anika Therapeutics Reports Third-Quarter Financial Results

Anika Therapeutics Reports Third-Quarter Financial Results

Achieves Revenue of $14.8 Million, Earnings per Share of $0.11 and Cash Generated from Operations of $2.2 Million for the Quarter

Reports on FDA Progress with Monovisc


BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NAS: 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 September 30, 2012.

Revenue

For the third quarter of 2012, Anika's total revenue was $14.8 million. This total represents a 20% decrease compared with the same period last year and reflects the impact of a temporary scale-up issue at our Bedford manufacturing facility that prevented the company from filling all of its orders for Orthovisc® during the quarter. The revenue shortfall impacted gross margin, operating, and net income. The issue has been resolved, and Anika expects to fill all of its orders in the current fourth quarter. In addition, the economic softness in Europe and the negative effect of foreign exchange affected revenue for the quarter.

For the nine-month period ended September 30, 2012, total revenue increased 5% to $48.8 million from the same period last year.

Product Gross Margin

Product gross margin for the third quarter of 2012 declined to 48.6%, from 58.4% in the third quarter last year, reflecting lower production volume.

For the nine-month period ended September 30, 2012, product gross margin was 53.3%, compared to 55.6% in the first nine months of 2011.

Operating and Net Income

Operating income for the third quarter of 2012 was $2.7 million, as compared to $4.8 million in the same period in 2011. Net income declined to $1.6 million, or $0.11 per diluted share, from $3.0 million, or $0.22 per diluted share, in the third quarter a year earlier due to the lower revenue and margins. The company's effective tax rate for the third quarter of 2012 was 38.6%, compared with 37.6% for the third quarter of 2011. The higher tax rate was due to Anika SRL.

For the nine-month period ended September 30, 2012, net income increased to $7.3 million, or $0.51 per diluted share, from $5.6 million, or $0.41 per diluted share, in the first nine months of 2011.

Operating Expenses

Research and development expenses for the third quarter of 2012 decreased to $1.2 million, from $1.5 million in the third quarter last year due to the timing of development activities. Selling, general and administrative ("SG&A") expenses in the third quarter of 2012 decreased to $3.6 million, from $4.7 million in the third 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 September 30, 2012 were $39.9 million, compared with $35.8 million at December 31, 2011. The increase was primarily the result of higher net income this year.

Management Commentary

"While the temporary supply constraint caused our financial results to fall short of our expectations, the fundamentals of our business remained very strong and we accomplished a great deal during the quarter," said Charles H. Sherwood, Ph.D., president and chief executive officer. "We have resolved the issues from the ramp up of our manufacturing in Bedford and are now prepared for increased production of our products. This is particularly timely now, because demand for Orthovisc continues to grow, and we expect to fulfill all of the delayed order requests in the fourth quarter."

"We also made progress on our PMA application for Monovisc, our single-injection osteoarthritis product, during the third quarter," said Sherwood. "We responded to the FDA on a subsequent set of questions they had requested for purposes of clarification, and currently expect a decision on our PMA application for Monovisc in the next two months.

"Looking ahead, we expect to report record fourth-quarter revenue, driven by increased demand for Orthovisc and the fulfillment of the delayed shipments. We also expect improved profitability in the quarter. Looking farther ahead, we are enthusiastic about the growth opportunities for our current products and the prospects for our product pipeline," concluded Sherwood.

Conference Call Information

Anika will hold a conference call to discuss its financial results, business highlights and outlook tomorrow, Wednesday, October 31, 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 866-730-5767 (international callers dial 857-350-1591) and use the passcode 37817443. 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) higher-rate manufacturing abilities, (ii) the delivery of delayed Orthovisc orders, (iii)the marketability of gel-based products, (iv) the timing of an expected decision by the FDA on Monovisc, (v) expectations for fourth-quarter revenue and profitability, (vi) and the prospects for Anika's current products and product pipeline. 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 September 30,

Nine Months Ended September 30,

2012

2011

2012

2011

Product revenue

$

14,055,440

$

17,756,000

$

46,551,045

$

44,230,840

Licensing, milestone and contract revenue

711,171

699,817

2,200,995

2,103,508

Total revenue

14,766,611

18,455,817

48,752,040

46,334,348

Operating expenses:

Cost of product revenue

7,221,028

7,394,922

21,718,735

19,655,288

Research & development

1,217,086

1,531,355

4,048,359

4,638,175

Selling, general & administrative

3,601,737

4,712,178

11,061,256

12,989,268

Total operating expenses

12,039,851

13,638,455

36,828,350

37,282,731

Income from operations

2,726,760

4,817,362

11,923,690

9,051,617

Interest income (expense), net

(45,161

)

(46,269

)

(145,493

)

(132,471

)

Income before income taxes

2,681,599

4,771,093

11,778,197

8,919,146

Provision for income taxes

1,036,349

1,794,575

4,483,960

3,335,576

Net income

$

1,645,250

$

2,976,518

$

7,294,237

$

5,583,570

Basic net income per share:

Net income

$

0.12

$

0.23

$

0.55

$

0.44

Basic weighted average common shares outstanding

13,287,463

12,817,910

13,237,629

12,744,471

Diluted net income per share:

Net income

$

0.11

$

0.22

$

0.51

$

0.41

Diluted weighted average common shares outstanding

14,459,154

13,765,533

14,357,791

13,729,835

Anika Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(unaudited)

September 30,

December 31,

ASSETS

2012

2011

Current assets:

Cash and cash equivalents

$

39,855,856

$

35,777,222

Accounts receivable, net of reserves of $464,442 and $334,473 at September 30, 2012 and December 31, 2011, respectively

16,343,600

17,307,786

Inventories

8,932,492

7,302,483

Current portion deferred income taxes

1,918,926

1,918,926

Prepaid expenses and other

1,351,403

1,831,127

Total current assets

68,402,277

64,137,544

Property and equipment, at cost

52,141,685

50,850,630

Less: accumulated depreciation

(16,204,216

)

(14,380,752

)

35,937,469

36,469,878

Long-term deposits and other

249,381

205,042

Intangible assets, net

21,464,089

23,148,563

Goodwill

8,818,920

8,883,407

Total Assets

$

134,872,136

$

132,844,434

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$

1,907,564

$

4,299,680

Accrued expenses

4,389,002

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

1,391,694

450,482

Total current liabilities

12,154,927

14,538,423

Other long-term liabilities

1,539,198

1,548,652

Long-term deferred revenue

2,869,440

5,019,440

Deferred tax liability

6,435,148

7,375,141

Long-term debt

8,400,000

9,600,000

Commitments and contingencies

-

-

Stockholders' equity:

Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively

-

-

Common stock, $.01 par value; 30,000,000 shares authorized, 13,804,975 and 13,630,607 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively

138,049

136,305

Additional paid-in-capital

65,142,128

63,441,433

Accumulated currency translation adjustment

(3,353,212

)

(3,067,181

)

Retained earnings

41,546,458

34,252,221

Total stockholders' equity

103,473,423

94,762,778

Total Liabilities and Stockholders' Equity

$

134,872,136

$

132,844,434

Anika Therapeutics, Inc. and Subsidiaries

Supplemental Financial Data

Revenue by Product Line and Product Gross Margin

Three Months Ended September 30,

2012

2011

%

Orthobiologics

$ 9,242,783

$ 10,377,222

-11%

Dermal

376,251

947,122

-60%

Ophthalmic

1,891,433

4,562,574

-59%

Surgical

1,426,273

1,068,522

33%

Veterinary

1,118,700

800,560

40%

Total Product Revenue

$ 14,055,440

$ 17,756,000

-21%

Product gross profit

$ 6,834,412

$ 10,361,078

Product gross margin

48.6%

58.4%

Nine Months Ended September 30,

2012

2011

%

Orthobiologics

$ 30,262,991

$ 28,177,115

7%

Dermal

1,033,302

2,335,881

-56%

Ophthalmic

8,515,160

8,045,203

6%

Surgical

3,874,405

3,748,277

3%

Veterinary

2,865,187

1,924,364

49%

Total Product Revenue

$ 46,551,045

$ 44,230,840

5%

Product gross profit

$ 24,832,310

$ 24,575,552

Product gross margin

53.3%

55.6%

Anika Therapeutics, Inc. and Subsidiaries

Supplemental Financial Data

Revenue by Geographic Region

Three Months Ended September 30,

2012

2011

%

Geographic Location:

United States

$ 11,911,946

$ 13,233,998

-10%

Europe

1,069,661

2,512,690

-57%

Other

1,073,833

2,009,312

-47%

Total

$ 14,055,440

$ 17,756,000

-21%

Nine Months Ended September 30,

2012

2011

%

Geographic Location:

United States

$ 38,317,667

$ 33,170,393

16%

Europe

3,937,427

6,887,323