Earnings Labs

Anika Therapeutics, Inc. (ANIK)

Q3 2014 Earnings Call· Sun, Nov 2, 2014

$15.42

-2.71%

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Q3 2014 Anika Therapeutics’ Earnings Conference. At this time, all participants are in a listen-only mode. Later, we will conducting a question-and-answer session and instructions will follow at that time. (Operator Instructions). As a reminder, this conference is being recorded. I would now like to turn the call over to Sylvia Cheung; CFO, you may go ahead.

Sylvia Cheung

Management

Thank you, Andrew. Good morning everyone and thank you for joining us. If you have not received a copy of the Anika news release, which was issued yesterday after the market closed or you would like to be added to our distribution list, please contact Sharon Merrill Associates at 617-542-5300. The news release is also posted in the Investor Relations section of our website at anikatherapeutics.com. In addition, a slide presentation is posted on our website. It illustrates many of the key points we’ll be covering during today’s call. The slides can be found in the Investor Relations section, 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 number 2. Before we begin, please remember that, the statements made in this call, which are not statements of historical facts are forward-looking statements as defined in the Securities and Exchange Act of 1934. These statements are based on 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. Please see our SEC filings for more information about factors that could affect our results. Please turn to slide 3 and I will begin our third quarter financial and franchise review. Anika continued to deliver strong results in the third quarter of 2014. Total revenue increased $4.3 million or 24% from the third quarter of last year to $22.1 million. Product revenue grew $5 million or 29% compared with the same period of last year. In Orthobiologics, our largest franchise, product revenue grew 47% from the third quarter last year. Although product revenues associated with the Monovisc U.S. commercial launch contributed to this growth,…

Charles Sherwood

Management

Thank you, Sylvia. I will begin with Orthobiologics, which is now and will continue to be Anika’s largest franchise for the near-term. As we stated previously, our revenue goal is to reach a 15% share of the global viscosupplementation market by the end of 2018. We’re executing on our three part strategy to achieve this goal. We may progress in each of the areas in the third quarter. The first leg of this strategy is to leverage our leadership in the U.S. as the only branded viscosupplementation offering with both single and multi-injection options. We expect our commercialization of Monovisc in the U.S. to generate greater brand awareness for Anika, which should drive market share gains and revenue growth for both Orthovisc and Monovisc in 2015 and beyond in the United States and also internationally. Our U.S. distribution partner DePuy Synthes Mitek Sports Medicine or Mitek is fully committed to supporting this strategy and working to maintain the strong position we’ve already established for Orthovisc in the multi-injection market, while at the same time rapidly capturing single-injection market share with Monovisc. We’re off to good start. Monovisc continues to be very well received by the orthopedic physician community and by patients. We believe the majority of our U.S. Monovisc sales thus far reflect conversions by physicians and patients, who previously used competing single-injection products rather than cannibalization of the Orthovisc product. As a result, we’re exiting the third quarter with an approximate 1% share of the U.S. single-injection market, up from zero just a few months ago. This puts us slightly behind in terms of reaching our previously stated goal of 2% to 3% of the U.S. market share by the end of the year. Monovisc has been well received by the orthopedics physician community but as Sylvia stated reimbursement…

Operator

Operator

Thank you. (Operator Instructions). First question comes from Mark Landy of Summer Street. Your line is open. Mark Landy – Summer Street: Good Morning guys.

Charles Sherwood

Management

Good morning.

Sylvia Cheung

Management

Good morning. Mark Landy – Summer Street: I guess I use my one question. Cingal trial, would you press release the data when you get that or how should we think about the release of the Cingal data when you get it?

Charles Sherwood

Management

I’ll make no commitments to guarantee that we will press release the data when we get the data, because of course in the past we’ve never done that. However we’re still trying to formulate our approach to that. So, I won’t say yes and I won’t say no, but historically we’ve really haven’t done much in that area before and we’re looking to see what the best thing to do is and also we spent a lot of time trying to understand how we will go beyond that and actually publish the data in a reputable journal as well. So I can’t make any commitments to you but certainly we’ve build a sub so we have to find some way of communicating the result in a timely way. Mark Landy – Summer Street: My follow up would be it sounds like and you’ve telegraphed in the past that you’re going to be using the current data as the basis for the PMA? So is it fair to assume that, the PMA will be submitted some part in the first half of 2015 probably towards the latter half of the 2015, towards the latter half of the first half of 2015?

Charles Sherwood

Management

Basically yes, with the caveat that the clinical end points are med in a statistically effective and clinically meaningful fashion, because this is the standard for the FDA. The protocol is one that has very, very similar to what we’ve used in the past. We’ve powered the study based on our experience in the past and so, if we meet all of our end points with robust performance, there is no reason why the trial would not meet the criteria necessary for PMA approval. Mark Landy – Summer Street: Thank you.

Operator

Operator

Thank you very much. Our next question comes from the line of Joe Munda from Sidoti & Company. Your line is open, sir. Joe Munda – Sidoti & Company: Good morning, Sylvia and Chuck. Thanks for taking the question.

Sylvia Cheung

Management

Good morning, Joe. Joe Munda – Sidoti & Company: Sylvia, I guess my question would be the $100 million that you referenced, was that for 2014 or 2015?

Sylvia Cheung

Management

It’s referring to 2014. Joe Munda – Sidoti & Company: Okay. Total revenue?

Sylvia Cheung

Management

That is correct. Joe Munda – Sidoti & Company: Okay, and then I guess my follow-up is, Chuck if all goes well with Cingal and the trial, when could you in your mind think of a launch for the product?

Charles Sherwood

Management

That’s a really difficult question to answer Joe, but if we’re able to, if the trial results were good and then we were able to put together a credible submission and we were able to do that in let’s say 6 to 8 months and given the FDA approval cycle maybe a year you can add up the time and then so maybe sometime in what is that come to late 2015 or early 2017. That’s if all goes really well. I would point out to you that you mentioned launch, the Cingal product in the United State is still unpartnered. Well, I’ll leave it there, it’s unpartnered. Joe Munda – Sidoti & Company: Okay. Thank you.

Operator

Operator

Thank you. That’s all the time we have for questions and answers today. I would like to turn the call back over to Mr. Sherwood for any further remarks.

Charles Sherwood

Management

Well, once again I would like to say thank you to everyone who participated in the call for your input and also for your interest in Anika. I truly believe that, these are exciting times for us and we do look forward to reporting to you once again on the fourth quarter and year-end earnings call. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This now concludes the program and you may all disconnect. Everyone have a great day. Speakers’, please remain on the line.