Anika Therapeutics Inc. (ANIK)

[EYEBUYSTOX]

Interesting article. In my opinion, operating two facilities until June-ish will hurt earnings and put pressure on the stock in the short term. Just more opportunity to get in before the rest of the world realizes the potential in this gem.

http://www.fool.com/investing/general/2011/03/02/wall-streets-best-hidden-stocks.aspx

[BioSpecialist]

Anik is on the move ...

Major Rally coming if we break $10 today .Still a fantastic buying opportunity .

[BioSpecialist]

Run up has just begun

5 Approvals on the way

[BioSpecialist]

Still time to get in on the cheap .

[BioSpecialist]

The Institutions increased their stake in Anika from 30% to 51% in the last few days .VERY POSITIVE SIGN

http://www.dailyfinance.com/company/anika-therapeutics-inc/anik/nas/institutional-ownership



Shares Outstanding: 13.4 M

Insiders/Mutual/Institutions holding : 8.4 M

Float : 5 M (excluding retail investors)

[BioSpecialist]

Good day to load up more cheap shares .

[BioSpecialist]

RALLLLYYYYYYYYYYYYYYYYYYYYY

10$+++ coming

[EYEBUYSTOX]

I also agree. Even if all 4 drugs are shot down by the FDA (highly unlikely IMO), this company has enough substance to limit the downside risk.

[stockslave]

I agree i is a great buy I.M.O IM IN FOR A NICE BLOCK

[EYEBUYSTOX]

February 14, 2011 5:57 PM EST

Anika Therapeutics, Inc. (Nasdaq: ANIK) shares are showing selling after-hours today following an announcement by the company that they still have not received timing for an FDA Advisory Panel meeting for MONOVISC. Additionally, the company said that the FDA did not approve their Bedford Facility, and will not until the equipment is permanently installed in Bedford. Finally, Anika said that they don't have timing set for three 510(k) premarket notifications filed for Anika Therapeutics S.r.l. products in October 2010. They were anticipating clearance for one at the end of 2010, and two before the end of Q111.

[FJE132]

OK, but why is it going south today?

[BioSpecialist]

GREAT BUYING OPPORTUNITY TODAY FOLKS

4 FDA APPROVALS COMING VERY SOON = EASY $$$$

[BioSpecialist]

Load up before the first FDA approval coming .


Anika Therapeutics (ANIK)

Market-Cap: 116 Mil
Cash: 26 Mil
Price: 8.60

Shares Out: 13.5



UPCOMING MILESTONES :

Monovisc (osteoarthritis) (PMA) FDA approval in 1Q 2011 << Blockbuster Potential

Hyaloglide 510(K) expected FDA approval 1Q 2011

Hyalonect 510(K) expected FDA approval 1Q 2011

Hyalofast 510(K) expected FDA approval 1Q 2011



FAB has commercialized three joint health products that Anika is planning to market in the United States along with MONOVISC™, upon its approval by the FDA. These FAB products include:

* Hyaloglide®, a gel used following tendon and/or peripheral nerve surgery;

* Hyalonect®, a knitted mesh used as a bone graft wrap; and

* Hyalofast™, a non woven matrix of HA used in arthroscopic surgery for the repair of chondral and osteochondral lesions.

We believe these products will only require FDA 510K clearance. These three products – as well as most others in FAB’s portfolio – come with a meaningful clinical data package.

Our goal is to obtain FDA clearance for Hyaloglide, Hyalonect and Hyalofast by the end of Q1 2011. We are building a direct sales force to market MONOVISC in the United States, and adding these three products to our portfolio should provide us with the critical mass we need to more effectively penetrate the domestic orthopedic/joint health market.

[BioSpecialist]

Load up folks

Major Breakout coming

[BioSpecialist]

RALLYYYYYYYYYYYYYYYYYYYYYy

Last chance to buy under 10$ .. 4 FDA APPROVALS COMING TO PUSH THIS STOCK TO 30$ .

[BioSpecialist]

Nice consolidation

Next big jump coming

[BioSpecialist]

Great buying opportunity today ..Load up before the big news is out

[BioSpecialist]

This stock is still significantly Undervalued . Anik awaiting 4 FDA approvals including one potential Blockbuster(Monovisc) , the first Approval could push this stock to $15+ .I think we could see $30+ with all FDA approvals . Anika is definitely one of the best Biotech Investment .GL

http://stockcharts.com/freecharts/gallery.html?anik

[BioSpecialist]

Load up before the stock moves into double digits .Anything below 12$ is a pure gift . GL


http://www.stoxline.com/quote.php?symbol=anik

Resistance1: 9.78
Resistance2: 11.42

Price and moving averages has closed above its Short term moving average. Short term moving average is currently above mid-term; AND above long term moving averages. From the relationship between price and moving averages; we can see that: This stock is BULLISH in short-term; and BULLISH in mid-long term.

[BioSpecialist]

This Stock has tremendous upside Potential and the downside risk is almost zero .


Listen to this slide Presentation(Registration required)
http://investor.shareholder.com/media/eventdetail.cfm?eventid=89297&CompanyID=ABEA-5FDIBY&e=1&mediaKey=49FA2DEA7A7CFA91150C33A086A01FEE


Great Pipeline
http://www.anikatherapeutics.com/innovation/pipeline/index.html


http://www.anikatherapeutics.com/innovation/spotlight/index.html

FAB has commercialized three joint health products that Anika is planning to market in the United States along with MONOVISC™, upon its approval by the FDA. These FAB products include:

* Hyaloglide®, a gel used following tendon and/or peripheral nerve surgery;

* Hyalonect®, a knitted mesh used as a bone graft wrap; and

* Hyalofast™, a non woven matrix of HA used in arthroscopic surgery for the repair of chondral and osteochondral lesions.

We believe these products will only require FDA 510K clearance. These three products – as well as most others in FAB’s portfolio – come with a meaningful clinical data package.

Our goal is to obtain FDA clearance for Hyaloglide, Hyalonect and Hyalofast by the end of Q1 2011. We are building a direct sales force to market MONOVISC in the United States, and adding these three products to our portfolio should provide us with the critical mass we need to more effectively penetrate the domestic orthopedic/joint health market.

[BioSpecialist]

With a market value of $96 million, Anika Therapeutics (ANIK) is a hidden growth story in the biotech arena .ANIK has been profitable for each of the past seven years.

2011 Price Target: $25.00+ .Get in now before the stock gets Discovered .Anika is a once in a lifetime opportunity .GLTA


Anika Therapeutics (Anik)

Market-Cap: 96 Mil
Cash: 26 Mil

Shares Out: 13.5



Monovisc (osteoarthritis) FDA approval in 1Q 2011

Hyaloglide 510(K) expected FDA approval 1Q 2011

Hyalonect 510(K) expected FDA approval 1Q 2011

Hyalofast 510(K) expected FDA approval 1Q 2011

[mlkrborn]

ANIK 6.40

[surf1944]

Anika Therapeutics, Inc. Q2 2010 Earnings Call Transcript

http://seekingalpha.com/article/219856-anika-therapeutics-inc-q2-2010-earnings-call-transcript?source=yahoo

[surf1944]

Anika Therapeutics Comments on Patent Litigation

http://finance.yahoo.com/news/Anika-Therapeutics-Comments-bw-2919291113.html?x=0&.v=1

[ikingulu]

Any good bio picks or pharmas out there

[surf1944]

Anika Therapeutics Communicates Status of Compliance Issues with the FDA

Press Release Source: Anika Therapeutics, Inc. On Thursday May 13, 2010, 5:44 pm EDT
BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted the corrective actions put forth by Anika to address the issues raised in the 2008 Warning Letter received by the company, and therefore has removed any restrictions placed upon Anika as a result of that letter.

Anika’s CEO, Charles H. Sherwood, Ph.D. commented, “We have worked very hard in tandem with the FDA to develop and implement a plan that will keep Anika at an exemplary level with respect to compliance. We appreciate all of the cooperation that we received from the Agency to aid in our progress.”

[surf1944]

http://www.mffais.com/anik

[surf1944]

Anika: A Hidden Biotech Buy

http://seekingalpha.com/article/200408-anika-a-hidden-biotech-buy

[mlkrborn]

still holding around 6.23.. Must be around its intrinsic value!
GLLs

[surf1944]

Anika Therapeutics Receives European CE Mark Approval for "ELEVESS Light"
Company Expands Aesthetic Franchise with New Product Used to Treat Fine Lines and Wrinkles

Plans European Launch in Early 2010

BEDFORD, Mass.--(BUSINESS WIRE)--Nov. 19, 2009-- Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid (“HA”) technology, today announced that it has received European CE Mark approval for “ELEVESS™ Light,” the Company’s latest aesthetic product used for the treatment of fine lines and facial wrinkles. ELEVESS Light will be distributed in the European market by the Company’s current aesthetic dermatology distributors.

“This approval expands our aesthetic dermatology product family and paves the way for an early 2010 launch of ‘ELEVESS Light’ in the European Union and other geographies that provide approvals based on the CE mark,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer. “Domestically, we are in discussions with the FDA about the pathway for approval for this new fine-line product.”

[surf1944]

http://www.mffais.com/anik

http://www.form4oracle.com/company/anika-therapeutics-inc-anik/company-transactions?id=6990

[mlkrborn]

UP $2 over $7 nice gain..

[surf1944]

Anika Therapeutics Receives Health Canada Approval for MONOVISC
Represents the first approval in North America for its Single-Injection Osteoarthritis Treatment

Press Release
Source: Anika Therapeutics, Inc.
On Thursday August 20, 2009, 9:24 am EDT

Companies:Anika Therapeutics Inc.
Topics:Health Care Sector
BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, today announced that it has received Health Canada approval for MONOVISC™, its single injection viscosupplement approved for the treatment of osteoarthritis of the knee. Anika expects to launch MONOVISC this month through its long-term ORTHOVISC® distribution partner in Canada, Rivex Pharma Inc., the specialty drug distribution division of Aurora, Ontario-based Helix BioPharma Corp. (TSX: HBP - News). MONOVISC has been broadly available in the European Union since the second quarter of 2008.

“We are very pleased to be the exclusive distributor of MONOVISC in the Canadian market and will begin aggressively marketing it immediately,” said Bill Chick, VP Product Distribution for Helix BioPharma Corp. “We believe that both patients and physicians stand to benefit from MONOVISC’s unique features: patients will welcome fewer office visits and lower treatment costs, while physicians will appreciate the simplicity of the single-injection regimen.”

“Health Canada approval marks an important next step as we continue to expand the geographic reach of our novel osteoarthritis treatment therapy and establish MONOVISC as the premier single-injection product on the market worldwide,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer. “We are successfully moving forward on our goal of achieving FDA approval for MONOVISC in the U.S. The initial PMA modules have been submitted to the FDA and are currently under review. We expect to submit the final module containing the clinical study data prior to year-end 2009. We are confident that MONOVISC will be as well received in North America as it has been in Europe.”

The Company previously announced that it has completed the clinical segment of the U.S. pivotal trial for MONOVISC, and is now focused on completing the retreatment study for MONOVISC, which is designed to demonstrate the safety and benefit of repeat injections.

About MONOVISC™

MONOVISC™ is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.monovisc.com&esheet=6033558&lan=en_US&anchor=www.monovisc.com&index=2.

[surf1944]

Coapt Systems, Inc. Launches Hydrelle(TM) a New, FDA-Approved Dermal Filler with Lidocaine for Significant Wrinkle Correction and Greater Patient Comfort
Press Release
Source: Coapt Systems
On Monday July 6, 2009, 12:01 am EDT

Companies:Anika therapeutics inc.
PALO ALTO, Calif., July 6 /PRNewswire/ -- Coapt Systems, Inc. (www.coaptsystems.com) announced the launch of Hydrelle(TM) a new, FDA-approved hyaluronic acid based dermal filler for the treatment of facial wrinkles, such as nasolabial folds, also called "smile lines." Hydrelle is the first FDA-approved hyaluronic acid filler formulated with an anesthetic (lidocaine) for greater patient comfort. Proven safe and effective, Hydrelle is also a financially attractive alternative to traditional fillers such as Juvederm® by Allergan Medical, and Restylane® by Medicis Pharmaceutical.

Hydrelle has been specifically formulated to deliver rapid results comparable to other hyaluronic acid fillers; and the lidocaine anesthetic is integrated, providing a more comfortable injection experience for patients. Hydrelle represents an attractive value for patients seeking a safe and cost-effective filler option, since patients only require approximately 50% of typical injection volumes, thus requiring fewer syringes to fully correct facial wrinkles. Hydrelle also represents a significant opportunity for aesthetic professionals to expand their respective practices by offering patients an advanced, long-lasting dermal filler with an affordable price, particularly during volatile economic times.

Hydrelle is indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. In a randomized, controlled pivotal U.S. study of 208 patients, Hydrelle was proven safe and effective. In a multi-center, international study, Hydrelle demonstrated patient and physician satisfaction, and filler effectiveness for up to one year.

Laureen DeBuono, President and CEO for Coapt Systems stated, "Coapt Systems has established an excellent reputation as a provider of superior, bioabsorbable suspension devices for face lift procedures within the aesthetic marketplace. Now we have a perfect opportunity to compliment our product portfolio with the Hydrelle dermal filler product line." "Hydrelle represents an important clinical and business distribution milestone between Coapt Systems and the world-class hyaluronic acid product developer and manufacturer, Anika Therapeutics (Nasdaq: ANIK - News)," said DeBuono.

"I look forward to using more Hydrelle and to continuing to offer it to my patients because I have experienced excellent results," said Michael C. Pickart, M.D., F.A.C.S. "The wrinkle correction is very good compared to competitive products currently on the market, and patients have found Hydrelle to be more comfortable during injection, with less pain. In particular, Hydrelle is definitely my preferred filler of choice for the oral commissures, since they are so hard to numb with dental blocks and topical creams."

Coapt Systems Executive Vice President, Global Marketing and Sales, David Barella stated, "The Coapt Systems sales and marketing team is delighted to introduce Hydrelle to the facial aesthetic community throughout the U.S. I believe that a long-lasting, more comfortable, and cost-effective dermal filler represents a valuable advantage to the millions of women and men that seek to improve their facial appearance every year." Additionally, Barella said, "Physicians will also enjoy the convenient, ready-to-use benefits that Hydrelle with lidocaine offers, without costly and labor intensive pre-injection mixing."

To order Hydrelle, please contact Coapt Systems at 800.963.7670, or visit the worldwide web at www.coaptsystems.com. Hydrelle is available to qualified physicians, or properly licensed practitioners only.

About Hydrelle:

Hydrelle is the first FDA-approved injectable dermal filler to combine hyaluronic acid and lidocaine, a local anesthetic that improves patient comfort, and provides physicians with a new alternative for their aesthetic practice. Designed, developed and manufactured by Anika Therapeutics, Hydrelle is formulated for durability based on its proprietary cross-linking technology and the highest concentration of hyaluronic acid. Hydrelle is exclusively distributed within the U.S. by Coapt Systems.

Hydrelle is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). In clinical studies, adverse events were usually mild to moderate in nature and generally resolved within seven days. The most common side effects were injection site reactions of swelling, redness, bumps, bruising and tenderness. Hydrelle should not be used by patients with severe allergies. For complete patient safety information, please consult the Hydrelle Instructions for Use.

About Coapt Systems, Inc.:

Coapt Systems develops and markets unique facial rejuvenation products that help produce beautifully natural, long-lasting results for forehead, brow, cheek, and neck lifts. Endotine® and Ultratine(TM) are clinically-proven products that provide face lift patients with minimally invasive treatment and rapid recovery. NovielleTM biocompatible hydrogel injectable fillers can provide immediate voice restoration for patients suffering from vocal fold insufficiency. Coapt Systems is venture-backed and headquartered in Palo Alto, California. For more information, please visit www.coaptsystems.com.

[surf1944]

Anika Therapeutics Appoints Frank J. Luppino as Chief Operating Officer
Seasoned Operations Executive Returns to Company

On Tuesday May 26, 2009, 4:05 pm EDT

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (NASDAQ:ANIK - News) today announced the appointment of Frank J. Luppino as chief operating officer. Luppino was most recently vice president of operations at Bionostics, a privately held developer, manufacturer and distributor of turnkey products for critical healthcare OEMs. As an integral member of the management team implementing Anika’s strategic growth plan, Luppino will oversee the operations, quality systems, regulatory and clinical affairs areas. Luppino previously served for eight years at Anika, culminating in the position of vice president of operations.

“We expect Frank to be instrumental in the next phase of Anika’s growth as we broaden our global presence through an expanding suite of innovative products and an increasing number of distributors,” said Charles H. Sherwood, Ph.D., president and chief executive officer. “Frank is an ideal complement to our management team, given his knowledge of Anika, proven expertise in business planning, sound analytical thinking and high level of energy and enthusiasm. During his tenure with Anika, Frank made significant contributions in developing our processes and enhancing our customer and supplier relationships.”

Prior to his position at Bionostics, Luppino served as vice president of operations at Anika Therapeutics from June 2003 until his departure in September 2007. He also had held the position of executive director of operations. Prior to joining Anika in 1999, Luppino was regional manager for AAC Consulting Group, a firm serving the pharmaceutical and medical device industries. From 1992 to 1998, he was regional manager for Raytheon Engineers and Constructors. Earlier in his career, Luppino was a project engineer with Black and Veatch Corporation, an architectural and engineering design firm. Luppino holds a bachelor’s degree in chemical engineering from Lehigh University.

[surf1944]

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News), a leader in products for tissue protection, healing and repair based on hyaluronic acid (“HA”) technology, today reported financial results for the quarter ending March 31, 2009.

During the first quarter, Anika:

Continued to strengthen its global position in joint health therapies with the domestic and international expansion of its flagship joint health product, ORTHOVISC®;
Increased both total revenues and product revenues by 8%; and
Grew joint health revenues by 25%.

Revenue

Anika’s product revenue increased by 8% to $8,519,000 for the first quarter of 2009, compared with $7,868,000 in the same period last year. The increase in product revenue for the quarter was primarily attributable to strong domestic and international sales of the Company’s ORTHOVISC product line, as well as gains from MONOVISC sales.

Total revenue for the first quarter of 2009 increased 8% to $9,200,000 from $8,549,000 in the first quarter of 2008.

Product Gross Margin

Product gross margin for the first quarter of 2009 increased to 62% from 59% in last year’s first quarter. The improvement in gross margins was due primarily to the growth in joint health product revenue, resulting in a more favorable product mix.

Other Operating Expenses

Research and development expense increased to $2,194,000 compared with $1,508,000 in the same period last year, primarily due to the U.S. clinical trials for MONOVISC, manufacturing validation activities at the Bedford facility, and other development activities in joint health and aesthetics. Selling, general and administrative expense was $3,035,000 compared with $3,069,000 in the same period last year.

Net Income

Net income for the first quarter of 2009 was $523,000, or $0.05 per diluted share, compared with $618,000, or $0.05 per diluted share, for the same period last year. The decrease in net income in the first quarter was due to the current lower interest rate environment.

Other

Anika’s cash and cash equivalents at March 31, 2009 were $40,427,000 compared with $43,194,000 at December 31, 2008. The decrease in cash was due to greater working capital needs, and planned capital expenditures, as well as a payment for the Company’s debt obligation related to the new facility.

Management Commentary

“Anika began the year with another quarter of solid revenue growth, driven primarily by our joint health franchise,” said Charles H. Sherwood, Ph.D., Anika’s president and chief executive officer. “Revenues for joint health were up by 25 percent with strong domestic and international contributions.”

“After having completed the enrollment for our U.S. pivotal clinical trial for Anika’s new single-injection osteoarthritis treatment, MONOVISC, and as we did with ORTHOVISC, we initiated a follow-up reinjection study for the product,” said Sherwood. “In this study, we plan to re-treat approximately two-thirds of the initial patients in order to demonstrate the safety of repeat injections. We are on-track to file for marketing approval for MONOVISC in the U.S. by the end of this year.”

“Looking forward, we plan to continue to capitalize on strong trends in joint health as we broaden our presence through an increasing number of distributors and an expanding suite of innovative products,” said Sherwood. “Even in the short term, we believe that patients will turn to ORTHOVISC and other HA procedures to postpone expensive and debilitating knee replacement surgery during this recessionary period. We continue to look forward to generating revenue growth and improved income in 2009.”

[surf1944]

Form 10-K for ANIKA THERAPEUTICS INC

http://biz.yahoo.com/e/090309/anik10-k.html

[surf1944]

Exploiting Market Anomalies with Neglected Illiquid Stocks

http://seekingalpha.com/article/117964-exploiting-market-anomalies-with-neglected-illiquid-stocks?source=yahoo

[surf1944]

Anika Therapeutics Inc., Q4 2008 Earnings Conference Call

http://seekingalpha.com/article/124608-anika-therapeutics-inc-q4-2008-earnings-conference-call?source=yahoo

[surf1944]

http://www.mffais.com/anik.html

http://www.secform4.com/insider-trading/898437.htm

[surf1944]

Anika Therapeutics Reports Record Revenue for 2008
Thursday March 5, 5:15 pm ET

Total Revenue Grows 16% as Product Revenue Increases 23% for Full Year

2008 Accomplishments Include New Product Launches, Pipeline Achievements and Investments in New Manufacturing Facility to Accommodate Future Growth

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News), 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, 2008.

During the fourth quarter Anika continued to strengthen its global position in joint health therapies with the domestic and international expansion of its flagship joint health product, ORTHOVISC®, and the completion of enrollment for its U.S. clinical study of MONOVISC™, Anika’s single-injection osteoarthritis product. The Company also continued to invest in its future growth through its new manufacturing facility and product development initiatives.

Revenue

Anika reported product revenue of $8,285,000 for the fourth quarter of 2008 compared with $7,916,000 in the same period last year. For the year ended December 31, 2008, product revenue increased to $33,055,000, compared with $26,905,000 for full year 2007. The increase in product revenue for the quarter and the year was primarily attributable to strong sales of ORTHOVISC in the U.S. as well as sales of MONOVISC in Europe.

Total revenue for the fourth quarter of 2008 was $8,966,000, compared with $9,627,000 in the fourth quarter of 2007. Revenue for the fourth quarter of 2007 included $1.2 million in revenue related to the Company’s termination settlement with Galderma. For the year ended December 31, 2008, total revenue was a record $35,780,000, compared with $30,830,000 in 2007.

Product Gross Margin

Product gross margin for the fourth quarter of 2008 increased to 66% from 59% in last year’s fourth quarter. Product gross margin for the year ended December 31, 2008 was 60% versus 56% for full year 2007. The quarter and full year improvements in gross margins were due primarily to unit growth and strong worldwide ORTHOVISC revenue, as well as the impact of sales from new products.

Other Operating Expenses

Research and development expense for the fourth quarter of 2008 increased to $2,445,000 compared with $1,395,000 for the same period last year. Research and development expense for the year ended December 31, 2008 increased to $7,399,000 compared with $4,365,000 for full year 2007. The quarter and full-year increases were primarily due to clinical trials in the U.S. and Europe for MONOVISC, manufacturing scale-up activities for ELEVESS and MONOVISC, and development activities in joint health products.

Selling, general and administrative expense for the fourth quarter of 2008 decreased to $2,450,000 from $2,885,000 for the same period last year, primarily due to unusually high legal, recruiting and consulting expenses in the fourth quarter of 2007. Selling, general and administrative expense for the year ended December 31, 2008 increased to $10,965,000 from $7,997,000 for full year 2007. The increase was due to the following three factors: 1) increased personnel costs and marketing expenses in connection with the Company’s joint health franchise; 2) higher costs at Anika’s Bedford facility due to a full year of occupancy and lease payments in 2008 versus only a partial year of payments and occupancy for 2007; and 3) higher year-over-year professional costs related to strategic and other corporate projects.

Net Income

Net income for the fourth quarter of 2008 was $1,095,000, or $0.10 per diluted share, compared with $1,673,000, or $0.15 per diluted share, for the same period last year. Net income for the year ended December 31, 2008 was $3,629,000, or $0.32 per diluted share, compared with $6,035,000, or $0.53 per diluted share, in 2007. The decrease in net income in both the fourth quarter and full year periods was due to higher operating expenses, as well as lower interest income.

Other

Anika’s cash, cash equivalents and short-term investments at December 31, 2008 were $43,194,000 compared with $39,405,000 at December 31, 2007. The increase was a result of the final drawdown in the fourth quarter of 2008 under the Company’s line-of-credit, partly offset by lower accounts payable.

http://biz.yahoo.com/bw/090305/20090305006243.html?.v=1

[surf1944]

10-Q for ANIKA THERAPEUTICS INC

http://biz.yahoo.com/e/080808/anik10-q.html

[surf1944]

Anika Therapeutics Reports 28% Increase in Revenue for Second Quarter 2008
Tuesday July 22, 6:34 pm ET
Joint Health Revenues Increase by 79% on Strong Domestic and European Sales

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News), a leader in products for tissue protection, healing and repair based on hyaluronic acid (“HA”) technology, today reported strong revenue growth for the quarter ending June 30, 2008. Anika continued to strengthen its global position in joint health therapies with the European launch of its single-injection osteoarthritis product, MONOVISC™, for the relief of knee pain as well as the further domestic and international penetration of its flagship joint health product, ORTHOVISC®. The Company also recently partnered with Artes Medical to market and distribute its cosmetic dermal filler, ELEVESS™, in the United States.

Revenue

Anika’s product revenue increased by 32% to $8,379,000 for the second quarter of 2008, compared with $6,332,000 in the same period last year. Product revenue for the first six months of 2008 grew 39% to $16,246,000 from $11,706,000 in the first six months of 2007. The increase in product revenue for the quarter was primarily attributable to strong domestic and international sales of the Company’s ORTHOVISC product line, as well as gains from its equine osteoarthritis product, HYVISC, and initial MONOVISC sales.

Total revenue for the second quarter of 2008 increased 28% to $9,060,000, compared with $7,100,000 in the second quarter of 2007. Total revenue for the first six months of 2008 increased 33% to $17,609,000 compared with $13,238,000 for the same period in 2007.

Product Gross Margin

Product gross margin for the second quarter of 2008 increased to 57% from 52% in last year’s second quarter. For the first six months of 2008, product gross margin was 58% compared with 53% for the same period in 2007. The improvement in gross margin was due primarily to overall unit growth as well as growth in domestic and international ORTHOVISC sales.

Other Operating Expenses

Research and development expense increased 65% in the second quarter to $1,645,000 compared with $996,000 for the same period last year. Research and development expense for the first six months of 2008 were $3,153,000 compared with $1,843,000 for the same period last year. The increases in both the second quarter and year-to-date periods were primarily due to clinical trials in the U.S. and Europe for MONOVISC, scale-up activities for MONOVISC in connection with the European launch, and development activities in joint health.

Selling, general and administrative expense increased 68% in the second quarter to $2,880,000 compared with $1,716,000 for the same period last year. Selling, general and administrative expense for the first six months of 2008 were $5,949,000 compared with $3,291,000 for the same period in 2007. The increases in both the second quarter and year-to-date periods were primarily the result of marketing expenses associated with the launch of our new products, increased personnel costs, expenses related to the Company’s new headquarters facility, and higher legal and consulting costs related to strategic projects.

Net Income

Net income for the second quarter of 2008 was $813,000, or $0.07 per diluted share, compared with $1,365,000, or $0.12 per diluted share, for the same period last year. Net income for the first six months of 2008 was $1,430,000, or $0.12 per diluted share, compared with $2,566,000, or $0.23 per diluted share, for the first six months of 2007. The decrease in net income in the second quarter and first six months of 2008 over last year was due to the Company’s planned investment in clinical trials, product development and higher operating expenses as outlined above.

Other

Anika’s cash and cash equivalents at June 30, 2008 were $37,297,000 compared with $39,406,000 at December 31, 2007. The decrease reflects the Company’s investment in its Bedford facility to increase capacity and upgrade its new product development capabilities. As of June 30, 2008, the Company has borrowed $8,000,000 under its $16,000,000 line-of-credit in connection with its Bedford facility build-out.

FDA Warning Letter

Anika Therapeutics recently received a Warning Letter from the FDA in response to an earlier FDA Form 483 Notice of Observations issued to the Company following an inspection at the Company’s Woburn facility. Anika has fully cooperated with the FDA to address the issues in the Form 483 filing and has issued a response to the FDA’s Warning Letter. The Company has developed a corrective action plan, will provide the FDA with progress reports as promised, and looks forward to our next inspection. Product quality is the highest concern to Anika Therapeutics and the Company is committed to the continual improvement of its quality systems and investing to make those systems best-in-class.

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Anika Therapeutics Announces Exclusive U.S. Distribution Agreement for Elevess Injectable Dermal Filler
Tuesday July 8, 7:15 am ET
Anika's HA-based Dermal Filler Incorporating Lidocaine to be Distributed by Artes Medical

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (NASDAQ:ANIK - News), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, announced today that it has signed an exclusive agreement with Artes Medical, Inc. (NASDAQ:ARTE - News), a medical aesthetics company, to distribute and market ELEVESS™, Anika’s cross-linked hyaluronic acid-based (HA) injectable dermal filler. ELEVESS is an injectable filler that reduces the appearance of facial wrinkles and folds such as nasolabial folds, and is the first HA-based dermal filler approved by the Food and Drug Administration (“FDA”) to incorporate the anesthetic lidocaine to improve patient comfort. Artes Medical manufactures, markets and sells ArteFill®, the first and only FDA-approved, nonresorbable dermal filler for the correction of smile lines.

“We are very pleased to reach this agreement with Artes Medical to distribute ELEVESS, our breakthrough dermal filler product,” said Anika President and Chief Executive Officer Charles H. Sherwood, Ph.D. “After undertaking an extensive search with a number of potential commercialization partners, we believe that Artes Medical possesses the capabilities that can help ELEVESS achieve its full potential in the marketplace. Artes’ highly experienced sales force has well established relationships with the leading aesthetic physicians in markets throughout the United States. In addition, their complementary product, deep understanding of the injectable dermal filler marketplace and compatible culture make this a highly synergistic agreement for both companies.” Under the terms of the agreement, Artes Medical will receive exclusive distribution and marketing rights for ELEVESS in the United States.

“Going forward, we are actively seeking partners with characteristics and capabilities similar to Artes Medical to help us distribute ELEVESS in Europe, Canada, and the rest of the world,” said Sherwood. “Our hopes are high for this product and we are eager for an increasing number of doctors and patients to experience its benefits.”

About ELEVESS:

Anika’s ELEVESS is the first FDA approved injectable dermal filler to combine hyaluronic acid (HA) and lidocaine, a local anesthetic that improves patient comfort, and provides physicians with a new alternative for their aesthetic practice. Hyaluronic acid is a naturally occurring polymer found throughout the body and is present in the skin, where it supports skin structure and elasticity. Designed for longer durability based on its proprietary cross-linking technology and its high concentration of Anika’s chemically modified hyaluronic acid, ELEVESS has been approved for sale in the United States, the European Union and Canada.

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Anika Therapeutics Announces Commercial Availability of MONOVISC(TM) in Europe
Monday June 30, 10:11 am ET
Unique Osteoarthritis Treatment Provides Joint Pain Relief in a Single-Injection Regimen

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, today announced that it has begun shipping MONOVISC™ to Europe. MONOVISC is a single-injection viscosupplement therapy approved in the European Economic Area for treatment of osteoarthritis symptoms in all synovial joints. Other viscosupplements are indicated for specific joints, and may require up to five injections for the same treatment.

“MONOVISC is designed for faster pain relief and longer durability thanks to its proprietary cross-linking technology. MONOVISC’s single-injection regimen benefits both patients and physicians by minimizing the number of office visits, thereby lowering costs to the patient and the healthcare system,” said Charles H. Sherwood, Ph.D., Anika’s president and chief executive officer.

“MONOVISC is an important advancement in the care of osteoarthritis,” said Dr. Mauro Bausani, an investigator in the MONOVISC European clinical study. “We are excited that our recent clinical study data appears to replicate the safety and efficacy profile of ORTHOVISC® but in a single injection regimen.”

“The proprietary technology that we have developed for MONOVISC will form the core of our combination HA products for osteoarthritis treatment in the future,” continued Sherwood. “Our process of lightly cross-linking the hyaluronic acid polymers provides for enhanced durability while retaining all of the natural benefits of HA.”

The Company previously announced a randomized, double-blind, controlled study of MONOVISC that is taking place in the United States and Canada, and a separate clinical study that is ongoing at several European sites.

About MONOVISC™

MONOVISC™ is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. It is the only single-injection viscosupplement therapy approved for relief of joint pain in all synovial joints. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit www.monovisc.com.

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Anika Therapeutics Reports Strong Revenue Growth for First Quarter 2008
Wednesday April 30, 5:15 pm ET
Revenues Rise 39%, with Gains Across All Product Lines
Joint Health Revenues Increase by 56% on Strong Domestic and European Sales


BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News), a leader in products for tissue protection, healing and repair based on hyaluronic acid (“HA”) technology, today reported strong revenue growth for the quarter ending March 31, 2008. Each of the company’s product lines experienced double-digit revenue increases during the quarter. Anika continued to strengthen its global position in joint health therapies with well-received initial response in Europe of ORTHOVISC®Mini, its new HA osteoarthritis treatment specifically targeted for smaller joints, and progress on a key U.S. clinical study of its single-injection osteoarthritis product, MONOVISC™, for the relief of knee pain.

Revenue

Anika’s product revenue increased by 46% to $7,868,000 for the first quarter of 2008, compared with $5,374,000 in the same period last year. The increase in product revenue for the quarter was primarily attributable to strong domestic and international sales of the Company’s ORTHOVISC® product line, as well as double digit gains from its line of ophthalmic surgery and equine osteoarthritis products.

Total revenue for the first quarter of 2008 was $8,549,000, compared with $6,138,000 in the first quarter of 2007, an increase of 39%.

Product Gross Margin

Product gross margin for the first quarter of 2008 increased to 59% from 54% in last year's first quarter. The improvement in gross margins was due primarily to unit growth and strong domestic and international ORTHOVISC sales.

Other Operating Expenses

Research and development expense increased 78% to $1,508,000 compared to the same period last year, primarily due to clinical trials in the U.S. and Europe for MONOVISC, scale-up activities for MONOVISC in anticipation of a mid-year launch in Europe, and development activities in joint health and ELEVESS line extensions. The increased activity was led by senior management team additions in regulatory and clinical affairs, and in R&D.

Selling, general and administrative expense increased 95% to $3,069,000 compared to the same period last year, primarily due to increased headcount and marketing expenses in connection with new products in our joint health and aesthetic franchises; costs at the Bedford facility which commenced on May 1, 2007 and thus weren’t a factor in Q1 2007; and increased professional fees related to strategic projects, corporate governance, and shareholder protection matters.

Net Income

Net income for the first quarter of 2008 was $618,000 or $0.05 per diluted share, compared with $1,201,000, or $0.11 per diluted share, for the same period last year. The decrease in net income in the first quarter was due to higher operating expenses as outlined above, as well as lower net interest income due to a general decline in interest rates, our move last summer to U.S. Treasury securities, and fewer dollars invested due to our facility project.

Other

Anika’s cash, cash equivalents and short-term investments at March 31, 2008 were $38,953,000 compared with $39,406,000 at December 31, 2007. This decrease reflects the Company’s investment in its new Bedford, Massachusetts facility to increase capacity, and upgrade its new product development capabilities. In February 2008, the Company borrowed $4,000,000 in connection with its Bedford facility build-out, and it expects to borrow a total of up to $16,000,000 by the time the build-out is completed.

http://biz.yahoo.com/bw/080430/20080430006477.html?.v=1

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Form 10-K for ANIKA THERAPEUTICS INC
12-Mar-2008
Annual Report:

http://biz.yahoo.com/e/080312/anik10-k.html

http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001047469%2D08%2D002593%2Etxt&FilePath=%5C2008%5C03%5C12%5C&CoName=ANIKA+THERAPEUTICS+INC&FormType=10%2DK&RcvdDate=3%2F12%2F2008&pdf=

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Anika Therapeutics Launches ORTHOVISC(R) mini in Europe
Wednesday February 13, 7:38 am ET
Company Initiates Clinical Study of ORTHOVISC mini in Three EU Countries

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News) today announced that it has launched ORTHOVISC® mini in the European Union. ORTHOVISC mini is a smaller dosage indication of ORTHOVISC®, which has been marketed in Europe since 1996 and is used mainly for treatment of osteoarthritis of the knee. The Company is also initiating a post-approval clinical study of ORTHOVISC mini to gain additional clinical experience with regional opinion leaders who specialize in the treatment of osteoarthritis in small joints.

Source: Anika Therapeutics, Inc.

· Anika Therapeutics Launches ORTHOVISC(R) mini in Europe. (Photo: Business Wire). View Multimedia Gallery


“The launch of ORTHOVISC mini is a key milestone in our goal to enhance our joint health franchise by broadening the opportunities for our existing product line,” said Charles H. Sherwood, Ph.D., Anika’s president and chief executive officer. “We will utilize our existing European ORTHOVISC distribution network for this new product, and anticipate filling initial orders before the end of the first quarter.”

The multi-center clinical study with ORTHOVISC mini will target the carpometacarpal (CMC) joint at the base of the thumb. Anika has previously studied the use of ORTHOVISC in other small joints such as the ankle and temporomandibular joint (TMJ).

For more information, please visit our website at www.orthoviscmini.com.

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Anika Therapeutics Enrolls First Patient in U.S. Clinical Study for Monovisc(TM)
Monday January 7, 6:42 pm ET
Company Commences Study of MONOVISC for Single-Injection Joint Pain Relief of Osteoarthritis in the Knee

BEDFORD, Mass.--(BUSINESS WIRE)--Anika Therapeutics, Inc. (Nasdaq: ANIK - News) today announced that it has enrolled the first patient in a multi-center study evaluating its single-injection osteoarthritis product, MONOVISC™.

http://biz.yahoo.com/bw/080107/20080107006695.html?.v=1

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Improving Chaikin Money Flow (ANIK)