ANIK - Anika Therapeutics, Inc.

i gotta say anik is one to watch. 92m market cap with growing revenues and profits. 38m in cash on hand(3.38per share) only 14m in debt.

this all establishes that there is strength in the company and no problem lasting a long time while they develop drugs.

no for the speculation.

looks like they have a drug to go on the maket in 2010.
"We made steady progress on the PMA for our single-injection osteoarthritis product, MONOVISC, in preparation for a US launch in 2010. We secured regulatory approval from MONOVISC in Canada, and began selling product through Rivex Pharma, our long term Canadian ORTHOVISC distribution partner."


also a fda filing to be made next month

"While selected international markets are ripe with potential for MONOVISC, we see the greatest opportunity for this product in the United States. As I mentioned last quarter, we’re taking a modular approach to the filing of the PMA for MONOVISC, to allow for the fastest approval process possible. We have received some fairly straight forward feedback from the FDA and the modules that we have filed, and are in the process of addressing their questions.

The final component to complete our FDA filing is the clinical study module. We remain on track to complete our submission, by filing that module in December. That submission will also include the data from our re-treatment study. About 250 patients were re-injected with the purpose of confirming the benefits of MONOVISC re-treatment. These patients then underwent an evaluation period."


also working on starting the fda approval process on another drug

"In addition to our Hydrelle launch, we are expanding our aesthetic franchise with the development of a less robust version of our product to be used for the treatment of fine lines. During the last month we filed for CE Mark approval, and we are planning to launch the new product at the beginning of 2010 in Europe and in other countries that approve products based on the CE Mark. Domestically, we are in discussions with the FDA about the pathway for approval for this fine line product."

 

 

Wow big day.

With a market value of $116 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: $30.00+ // 4 FDA approvals including a Blockbuster (Monovisc) which alone is worth more than current Market cap Coming within 2 Months .Get in now before the stock gets discovered.GLTA


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.

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)

Anik is a big buying opportunity . Load up on the cheap while you still can . GL There is really a lot of good news coming ..Anik will explode today ! Great Fourth Quarter Results http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9Mzc0MzM4M3xDaGlsZElEPTQxNzQyMXxUeXBlPTI=&t=1

Does anyone think the quick gains today will hold? The company seems promising.

Anik is still one of the best and undervalued Bio stocks out there .Still a huge buying opportunity . glta

Runup conmtinues ...Load up while its still significantly undervalued .Enjoy the ride to 30 dollars

Anika Therapeutics Reports Record First-Quarter Revenue and Earnings
2 days 17 hours 57 minutes ago - BusinessWire via Comtex
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 March 31, 2012.

Revenue

For the first quarter of 2012, Anika's product revenue increased 23% to $13.6 million, from $11.1 million in the first quarter of 2011. Total revenue for the first quarter of 2012 increased 22% to $14.4 million in the first quarter of 2012, from $11.7 million in the first quarter of 2011. This growth was primarily driven by strong domestic sales of Anika's flagship product, Orthovisc(R). Higher international sales of Orthovisc, Monovisc(R) and post operative adhesion prevention products from Anika S.r.l., as well as U.S. shipments of ophthalmic products, also contributed to the revenue increase.

Product Gross Margin

Driven by a more profitable product mix, product gross margin for the first quarter of 2012 improved to 53%, from 49% in the first quarter of last year.

Operating and Net Income

Operating income for the first quarter of 2012 increased to $3.1 million, from $557,000 in the same period in 2011. Net income rose to $1.9 million, or $0.14 per diluted share, from $324,000, or $0.02 per diluted share, in the first quarter a year earlier. This growth was driven by a combination of increased revenue, higher gross margin, and lower selling, general and administrative expenses. The Company's effective tax rate for the first quarter of 2012 was 36.5%, versus 37.1% for the first quarter of 2011.

Operating Expenses

Research and development expenses for the first quarter of 2012 at $1.5 million was approximately the same compared to last year's first quarter. 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 new preclinical and clinical studies.

Selling, general and administrative expenses in the first quarter of 2012 decreased to $3.4 million, from $4.0 million in the first quarter of 2011. The decrease in expense for the quarter was primarily due to placing in service the remainder of the Bedford manufacturing facility. Prior to this quarter, the previously unoccupied space was expensed to SG&A.

Cash and Cash Equivalents

Anika's cash and cash equivalents at March 31, 2012 were $34.0 million, compared with $35.8 million at December 31, 2011. The decrease was primarily the result of lower cash collections on accounts receivable due to a high proportion of the Q1 2012 sales occurring in March 2012, and inventory build during the quarter.

Management Commentary

"Anika began 2012 on a solid note with a record first-quarter with respect to earnings and 22% total revenue growth," said Charles H. Sherwood, Ph.D., president and chief executive officer. "The growth on our top line continues to be driven primarily by sales of Orthovisc in our orthobiologics franchise, domestically and internationally. This also was a strong quarter for international sales of Monovisc and our post operative adhesion prevention products from Anika S.r.l., as well as U.S. sales of our ophthalmic products."

"This also was a good quarter for Anika from an operational perspective," said Sherwood. "We received approval from the FDA to manufacture Orthovisc and Hyvisc(R) as well as our proprietary ophthalmic products for manufacture at our Bedford, Mass. facility for sale in the United States. We are working with Bausch & Lomb to obtain approval to manufacture their ophthalmic products in the Bedford facility. This is the final step toward significantly improving our operational efficiency by consolidating all of our manufacturing in Bedford -- a process we expect to complete in June of this year."

"Anika performed well in the first quarter, and could have done even better but for some supply/demand imbalances in our Woburn facility that pushed some shipments into the second quarter, and some softness in Anika S.r.l.'s revenue due to a first-quarter distribution partner change in Italy. These issues have been addressed, and we believe that we are well-positioned for record results in the second quarter and year, and also to achieve our stated targets for growth in revenue and operating margin, as further operational improvements in 2012 unfold," Sherwood concluded.

nice runner til last week