Earnings Labs

Anika Therapeutics, Inc. (ANIK)

Q4 2009 Earnings Call· Wed, Mar 17, 2010

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the fourth quarter and year-end 2009 Anika Therapeutics investors' conference call. My name is Clarissa, and I'll be your coordinator for today. At this time, all participants are in a listen-only mode. We will conduct a question-and-answer session towards the end of this conference. I would now like to turn the call over to Mr. Kevin Quinlan, Anika's Chief Financial Officer. Please proceed.

Kevin Quinlan

Chief Financial Officer

Thank you, Clarissa, and good morning, everyone. If you have not received a copy of Anika's news release, which was issued yesterday after the market closed, or would like to be added to our contact list, please contact Sharon Merill Associates at 617-542-5300. The news release is also posted on Anika Therapeutics' Web site at anikatherapeutics.com. Also, I want to mention that we have slides posted on the Anika Web site that illustrates some of the financial information we'll be discussing during today's call. These slides can be found on the Investor Relations section of the site, under the Events, Webcasts, and Presentations tab. We invite you to take a moment to open the file and follow the presentation along with us. Please turn to slide two. Before we begin, please remember that the statements made in this call, which are not statements of historical fact are forward-looking statements as defined in the Securities and Exchange Act of 1934. Words such will, believe, appear, plan, expect, anticipate, forward, seek, continued target, goals, objectives, on track, intent, pursue, outlook as well as other expressions, which are predictions or indications of future events or trends and which do not constitute historical matters, identify forward-looking statements. These statements are based on the current beliefs and expectations of management, and are subject to significant risks and uncertainties. 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, which include those set forth in last evening's press release and the company's SEC filings. Please move now to slide three as I turn the call over to Anika's President and Chief Executive Officer, Dr. Charles Sherwood.

Charles Sherwood

Management

Thank you, Kevin. We're happy to have all of you with us this morning on our fourth quarter and year-end conference call. We ended a successful year with strong fourth quarter financial results and a major acquisition that has very exciting growth implications for Anika. Total revenue in the fourth quarter increased by 18% year-over-year, while product revenue was up 20% marking the fourth consecutive year of growth in product revenue. We also reported $0.06 per diluted share for the quarter. Excluding the costs associated with the FAB acquisition, Q4 EPS was $0.17, compared with $0.10 in the fourth quarter a year ago. In addition to reporting another quarter of solid financial results, we completed two major milestones. First, we filed the final module of our PMA for MONOVISC, Anika's single injection osteoarthritis product, with the FDA. And second, we acquired Fidia Advanced Biopolymers or FAB, which provides us with a robust new growth engine through a suite of complementary products, R&D pipeline products, and two new innovative HA technologies. That advances our vision to provide therapeutic products that go beyond pain relief to protect and restore damaged tissue. We also announced our decision to go to direct commercialization in the United States with MONOVISC, a decision that fits nicely with our acquisition of FAB. I'll go into more detail about our achievements in the fourth quarter and discuss our goals for 2010 after Kevin reviews the financial results. So with that, I'll turn it back over to you, Kevin.

Kevin Quinlan

Chief Financial Officer

Thanks, Chuck. Please turn to slide four in the presentation. We completed what was a year of accomplishments with strong financial results as we grew both revenues and earnings for 2009. Total revenue in the fourth quarter grew 18% to $10.6 million. For the full year of 2009, total revenue increased 12% to $40.1 million. Product revenue grew by 20% for the quarter and 13% for the year. The quarterly and annual increases were driven primarily by a strong performance of our joint health franchise. Looking in depth at our joint health franchise, if you turn to slide five, you'll see that revenue increased by 17% to $6 million for the fourth quarter. For the full year 2009, joint health revenue was up 22% to $22.9 million. Domestic joint health sales increased by 32% for the quarter and 28% for the year. International joint health sales were down by 18% in the quarter, but up by 8% for the year. Turning to our aesthetic dermatology franchise, with Coapt Systems continuing their efforts, sales increased six-fold to $710,000 in the fourth quarter, and are up 191% to $1.5 million for the year. As you might remember, Coapt launched Hydrelle during the third quarter. Turning to slide six, let's take a look at the income statement. Gross margins were 64% in the quarter, compared with 66% in last year's fourth quarter. The decline was due to higher manufacturing activity in the fourth quarter of 2008 as a result of the transition throughout – of operations to our Bedford facility. This transition is taking place by product line and will result in manufacturing activities occurring in both facilities for a significant portion of 2010. As a result of this activity, we expect a slight decline in margins this year. For the full year,…

Charles Sherwood

Management

Thank you, Kevin. I’d like to begin by discussing our joint health franchise, which is where we see our greatest opportunities for growth going forward. I’ll then discuss the FAB acquisition because FAB adds much value to Anika in joint health, but also in other areas. I’ll then provide a brief update on Anika’s other product franchises as usual. And finally, I will discuss our goals for 2010. So let’s get started with out joint health franchise. The fourth quarter of 2009 capped another very successful year for joint health. ORTHOVISC continued to perform in line with our high expectations, both in the US and abroad. In fact, this was the fourth consecutive year that we grew revenues by 20% year-over-year. Domestically, we increased our market share position. And we believe we're at approximately 12% as of year-end. This compares with 10% at the end of 2008. Internationally, we continued to expand our distribution network, advancing registration and commercialization in new territories. During the fourth quarter, we signed a two-year extension with our French distributor, who has been performing very well with both ORTHOVISC and MONOVISC. In addition to France, key international performers for the year were Austria, Hungary, and Egypt. We are hopeful that the publications of clinical data from our MONOVISC trial, around mid-year, should accelerate international sales of this product. One very important highlight for the quarter as I mentioned in my introduction, was the filing of our PMA for MONOVISC with the FDA. We have taken a modular approach with the PMA to allow for the fastest approval process possible. In December, we completed and submitted the clinical study module, including data from our re-treatment study. We had been receiving feedback from the FDA as we filed the modules throughout the year. And we are addressing…

Operator

Operator

(Operator Instructions) And we will pause for a moment to see if we have a list of names. And your question comes from the line of Ross Gordon [ph] of RGA [ph]. Please proceed. Ross Gordon – RGA: Good morning.

Kevin Quinlan

Chief Financial Officer

Good morning. Ross Gordon – RGA: I’d like to know how the – what’s going to happen with ORTHOVISC considering you’re using a different sales force for MONOVISC?

Kevin Quinlan

Chief Financial Officer

We think that that’s going to be an advantage. The partners on the ORTHOVISC product have a significant investment into that product line. And it’s a very high quality product. There's room in the market for multiple injection products as well as single injection products. And we think that there’s every reason to believe that they’ll continue to do well with it. Ross Gordon – RGA: But they will not be selling MONOVISC?

Kevin Quinlan

Chief Financial Officer

That is correct. Ross Gordon – RGA: Okay. Thank you.

Kevin Quinlan

Chief Financial Officer

You're welcome.

Operator

Operator

And there are no further questions. As this time I like to turn the call back over to management for closing remarks.

Charles Sherwood

Management

Thank you, Clarissa, and thanks to everyone for joining us today. These are exciting times at Anika, and we look forward to updating you on our progress in our next Q1 conference call. Thank you.

Operator

Operator

Ladies and gentlemen, this concludes the conference for today. You may now disconnect. Good day.