Earnings Labs

Anika Therapeutics, Inc. (ANIK)

Q4 2007 Earnings Call· Thu, Mar 6, 2008

$12.27

-19.59%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-10.71%

1 Week

-15.01%

1 Month

-11.91%

vs S&P

-16.31%

Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the fourth quarter 2007 Anika Therapeutics investors conference call. My name is Karma, and I will be your coordinator for today. (Operator Instructions) I would now like to turn the call over to your host for today's conference, Mr. Kevin Quinlan, Anika Therapeutics' Chief Financial Officer. Please proceed, Kevin.

Kevin Quinlan

Management

Thank you, Karma, and good morning, everyone. If you have not received a copy of the Anika news release which was issued yesterday after the market closed or would like to be added to our contact list, please contact Sharon Merrill Associates at 617-542-5300. The news release also is posted on the Anika Therapeutics website at anikatherapeutics.com. 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 Exchange Act of 1934. Words such as will, believe, appear, plan, expect, anticipate, forward, seek, continue, target, goals, objectives, on track, intend, 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 upon 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, including those set forth in last evening's press release, the Company's SEC filings and other press releases. A copy of the press release has been included as an exhibit to an 8-K that was filed with the Securities and Exchange Commission and has been posted on the Anika website. I would now like to turn the call over to Anika's President and Chief Executive Officer, Dr. Charles Sherwood.

Charles Sherwood

Management

Thank you, Kevin and thanks to everyone for joining us today. 2007 was a very successful year for Anika, both financially and operationally. It was capped by our fourth quarter that saw a 56% increase in product revenue, thanks primarily to strong sales worldwide of our flagship product ORTHOVISC. We also made significant progress on a number of initiatives that position our joint health products for growth in the future and expand our opportunities in the dermal filler market. We're pleased to report that once again, we saw a strong growth in ORTHOVISC unit sales from our US partner Mitek. In fact, domestic unit sales more than doubled during both the quarter and the year, and we believe that Mitek now holds about an 8% market share with our ORTHOVISC product. As we expected, this business has been able to capitalize on the unique reimbursement code we received from CMS for ORTHOVISC last year. Outside the US, the second half of the year saw strong performance in ORTHOVISC sales by a number of our partners. But perhaps, most importantly during the year, we made great strides in strengthening our global position in joint health therapies. Toward that end, we recently launched ORTHOVISC mini in Europe, our new HA based osteoarthritis treatment specifically targeted for smaller joints. We also begin a key US clinical study of our single-injection osteoarthritis product, MONOVISC, for the relief of knee pain. We plan to introduce MONOVISC by mid-year in the European market through our existing distributors. Now on the aesthetics front, we 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. Interest is high among all potential partners we have spoken with, and we are fast-tracking our commercialization efforts to be ready to go once we have our partner on board. We are pursuing all aspects to this effort vigorously and we hope to generate ELEVESS revenues by mid-year. And finally, on the operational front, we successfully completed Phase 1 of the move into our new facility in Bedford. Our R&D, regulatory, marketing and administrative staffs are now fully settled, and were making progress on the manufacturing side of the facility. And with that, I will turn the call over to our CFO, Kevin Quinlan to review our financial results for the quarter and then I'll be back to review some of the operational highlights for the quarter and what we hope to achieve in 2008. Kevin?

Kevin Quinlan

Management

Thanks Chuck. Total revenue in Q4 was $9.6 million compared with $5.9 million in the fourth quarter of 2006. For the year, total revenue was a record $30.8 million in 2007 compared with $26.8 million in 2006. The quarterly improvement was driven by a 112% increase in worldwide ORTHOVISC sales. I will provide more detail for each of our key product areas. Domestic revenue from ORTHOVISC at $3.3 million grew a 101% in the fourth quarter compared with the same period of 2006. For the full year of 2007, domestic sales of ORTHOVISC were $10.1 million and grew more than 92% from 2006. Growth in domestic sales of ORTHOVISC continued to be fueled by the ongoing marketing investment by our distribution partner DePuy Mitek. The sales were also aided by the unique reimbursement code obtained for our product effective January 1, 2007. International sales of ORTHOVISC at $1.4 million grew a 142% over the fourth quarter of 2006 and continued the favorable trend that started in the third quarter of 2007. We saw strong performances by our partners in Turkey, Germany, Italy and Greece. For the full year, international ORTHOVISC sales were $3.5 million, a 42% decline over 2006, primarily as a result of the 2006 reimbursement changes in Turkey. The details of which we have discussed in prior press releases and conference calls. We're pleased with the level of business in the second half of 2007 that our Turkish distributor has achieved on a private pay basis. For both, the quarter and the year, our HYVISC business at $688,000 and $2.4 million respectively, increased significantly over 2006. This was a good rebound after a mediocre 2006. Our expectations for this product continue to be modest however. Although, at a low level of only $200,000, our INCERT result for the…

Charles Sherwood

Management

Thank you, Kevin. As I mentioned at the outset, the fourth quarter was a very positive quarter for us financially and operationally highlighted by the strong sales of our ORTHOVISC product. Domestically, we are very pleased with ORTHOVISC gains this quarter and for the full year. Unit sales trends from our US marketing and distribution partner Mitek continue to be very encouraging. Thanks to additional sales people at Mitek, their direct-to-consumer advertising program, and their favorable reimbursement code we received at the start of the year, we look forward to continued growth for 2008. Internationally, our strategy in joint health continues to focus on targeting countries where we can be successful in driving ORTHOVISC sales using our integrated approach to marketing, distributor relationships and reimbursement. In the fourth quarter, we realized strong unit sales from our Turkish, Italian and Grecian partners and our new distributor partner in Germany is off to a great start as well, all with double-digit sales gains in the fourth quarter. An important factor in this growth overseas during the second half of 2007 was the reformulation of ORTHOVISC to a new non-animal based form derived from bacterial fermentation. The use of non-animal based products is preferred in the European market and our new formulation has so far been well received. In line with our international distributor strategy, we recently signed a new partner in China for ORTHOVISC, who has committed to undertaking local clinical trials for the product. This follows our announced in last quarter of the new distributor in India. These two markets have good potential and we look forward to update you on their progress as they work their way through their registration process. We also look forward to providing you with updates on additional international partnerships. As we discussed in previous calls,…

Operator

Operator

(Operator Instructions). And the first question comes from the line of Amy Stevens from Susquehanna. Please proceed.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Thank you very much. Good morning, guys, how are you doing?

Kevin Quinlan

Management

Good morning, Amy.

Charles Sherwood

Management

Good morning, Amy.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Thanks for taking the question. I wanted to go through this with you in terms of your partner in discussion. Obviously, they are fairly well along in several circumstances: Do you think you are having the conversation with everyone that might be a potential partner with you at this point and that now it's just a matter of holding it down and getting to where you want to be with whoever becomes the ultimate partner, or are there players out there that you should be talking to that you haven't yet?

Kevin Quinlan

Management

Amy, this is Kevin. I think that we've identified all of the potential candidates in our process. We've gone through a pretty thorough examination of who would be a good candidate to market this product for the Company. So, yes, we think we've considered the right players out there.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Okay. All right. And is there, just a quick housekeeping item, could you give me the depreciation in CapEx for Q4 and for the year?

Kevin Quinlan

Management

Certainly. Let me grab that as we're talking.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Then I can follow-up with another question while you're doing that. This relates to ORTHOVISC mini and what you're seeing in Europe. Perhaps it's too early, but I'd still be interested in any early feedback that you're hearing. What are the primary -- what's going to be the majority usage in your opinion? Is it trigger-finger or, you know, what are the indications? Or is it more osteoarthritis? Where are you seeing the greatest usage of the product at this point?

Kevin Quinlan

Management

We've seen this as primarily a small joint product. The particular study that we've embarked on in Europe is looking at the thumb, the CMC joint. And that's certainly a good candidate for us. But ankle, elbow and -- Chuck may have some additional thoughts on that, but those are certainly good candidates for the product.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Is it a same size injection for all those three joints?

Charles Sherwood

Management

Pretty much. I would add a little more color to what Kevin said. We had run some trials in the recent past in the ankle. We've run some in the PMJ as well. The usage in both of those areas is growing. So these look like very attractive opportunities in addition to applications in the hand.

Kevin Quinlan

Management

Amy, coming back to your original question. The depreciation for the quarter was approximately $200,000 and for the year around $700,000. The increased run-rate for Q4, obviously, related to having moved into the Bedford facility in mid-November.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Okay. And CapEx?

Kevin Quinlan

Management

Well, the CapEx number is pretty large. As you know, we've spent approximately $17 million, of which 15 relates to the Bedford facility and some of that relates to the CTA -- excuse me -- the manufacturing suite that we have put in place for the facility that we have on the ELEVESS products.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Okay. And then in terms of the potential to introduce MONOVISC in the U.S.; what are you hearing about competitive products and their adoption at this point? What do you think is the reception for going toward a single-injection versus multiple-injections in the orthopedics community?

Charles Sherwood

Management

This is Chuck. There will likely always be a market for a multiple-injection product. It's hard at this point to gauge exactly how it will shake out between a single-injection product and a multiple-injection product. Probably, the majority of the practitioners but not a vast majority, maybe 60 plus percent, will move toward a single-injection product. But, as I said, there will still be in our case a market for the current ORTHOVISC formulation. To address the competitive issue: we're aware, as probably many others are, that there are certainly two competitive products that are trying to work their way through the clinical and regulatory maze. One of them is a Genzyme product, and another one is called DUROLANE, which is manufactured by a company called Q-MED, which I believe is the license property of Smith & Nephew.

Amy Stevens - Susquehanna

Analyst · Susquehanna. Please proceed

Yeah. Okay. All right. Well, thank you. I'll follow-up later. I appreciate it. Thanks.

Operator

Operator

And the next question comes from the line of Bill Gibson from Nollenberger. Please proceed.

Bill Gibson - Nollenberger

Analyst · Bill Gibson from Nollenberger. Please proceed

Yeah. Kevin, you gave some guidance on net for this year. Does that assume that ELEVESS is on the market in the second half?

Kevin Quinlan

Management

Yes, it does.

Bill Gibson - Nollenberger

Analyst · Bill Gibson from Nollenberger. Please proceed

Okay. That was it. Thank you.

Operator

Operator

(Operator Instructions). And there are no further questions at this time.

Kevin Quinlan

Management

Very good then.

Charles Sherwood

Management

Once again, we'd like to thank all of you for your interest in the Anika Therapeutics and for your support, and we look forward to giving you the next update in about six to eight weeks after the first quarter results. Thanks.

Kevin Quinlan

Management

Thank you very much everyone.

Charles Sherwood

Management

Thanks, Karma.

Operator

Operator

My pleasure. This concludes the presentation for today. Ladies and gentlemen, you may now disconnect. Have a wonderful week.