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BioSpecifics Technologies Corp. (NASDAQ:BSTC)

Q4 2013 Earnings Conference Call

March 6, 2014 8:30 am ET

Executives

Beth DelGiacco - Stern, IR

Tom Wegman - President

Pat Caldwell

Analysts

Joel Sendek - Stifel

Ram Selvaraju - Aegis Capital

Operator

Thank you for holding. Welcome to the BioSpecifics' Fourth Quarter and Full Year 2013 Financial Results Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Today's call is being recorded.

And I would now like to introduce your host for today's call, Beth DelGiacco of Stern Investor Relations. Please go ahead.

Beth DelGiacco

Good morning, everyone, and welcome to BioSpecifics' fourth quarter and full year 2013 conference call. Today, I'm joined by Tom Wegman, the President of BioSpecifics. He will provide you with a corporate update and a financial summary and after that we will open the call for your questions. Pat Caldwell will also be available for the question-and-answer portion.

Before we begin let me remind you that during today's call BioSpecifics will make forward-looking statements within the meaning of and made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-including statements.

The forward-looking statements include statements concerning among other things the timing of initiating a new clinical trial in human lipoma, reporting top-line data from clinical trials in frozen shoulder and cellulite and the study data in uterine fibroids and the success of clinical trials. The market opportunity for various indications that are improved during development, the potential for the XIAPEX label to be expanded in the Dupuytren's contracture indications for MULTICORDs and the potential effect on the market opportunity if the label is expanded, the timing of the submission of the MAA by Sobi in Europe, the Peryronie's disease, and the likelihood of approval, the timing of the submission by us (inaudible) lipoma and the likelihood that Auxilium will exercise its opt-in rights.

In some cases these statements can be identified by forward-looking words such as believe, expect, anticipate, plan, estimate, likely, may, will, could, continue, project, predict, goal, the negative or plural of these words and other similar expressions. These forward-looking statements are predictions based on BioSpecifics' current expectations and its projections about future events.

There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements including the ability of Auxilium and its partners to achieve their respective objectives for XIAFLEX, XIAPEX or CCH, the uncertainties inherent in the initiation of future clinical trials. The market for XIAFLEX or XIAPEX in a given indication being smaller than anticipated, the potential of CCH to be used and an initiation and outcome of clinical trials for additional indications, the receipt of any applicable milestone payments from Auxilium, the timing of regulatory filings and actions; and other Risk Factors set forth in BioSpecifics' Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Reports for the quarters ended March 31, 2013; June 30, 2013; and September 30, 2013, and it's current reports on Form 8-K filed with the Securities and Exchange Commission.

All forward-looking statements made on this call are made as of the date hereof, and BioSpecifics assumes no obligation to update these forward-looking statements.

I will now turn the call over to Tom.

Tom Wegman

Thank you, Beth, and good morning everyone. Looking back at 2013 I can say that this is one of the most memorable years in our history. We made progress on all fronts commercially and in our development pipeline.

As many of you know BioSpecifics is focused on developing collagenase based products known as collagenase clostridium histolyticum or CCH. CCH is currently marketed by our partner Auxilium as XIAFLEX in the U.S. and as XIAPEX in the EU for Dupuytren's contraction. XIAFLEX is also now marketed in the U.S. by Auxilium for the treatment of Peyronie's disease. XIAFLEX is the first and only biologic therapy indicated for the treatment of Peyronie's Disease.

We will discuss the Peyronie's launch progress in more detail in a moment, what we would like to note upfront how this achievement further proves the deep potential of CCH. It also propels XIAFLEX towards becoming a more widely used commercial product in multiple indications.

Also on today's call we will discuss news on the potential label expansion in our first commercially available indication, Dupuytren's contraction as well as commercial updates on XIAFLEX sales. We will also highlight achievements in our pipeline programs, which will include the following: the initiation of two trials in the fourth quarter of 2013 by Auxilium; a Phase IIb trial in frozen shoulder, and a Phase IIa trial in cellulites. The data reported from both the canine and human lipoma studies and preclinical uterine fibroid studies that we are sponsoring in conjunction with the medicine.

Before we discuss each of these programs, I'd like to start with the approval and launch of XIAFLEX for Peyronie's disease. This approval is important to us for many reasons. The milestone payment and future royalties from sales will offer an added economic benefit to our company. The approval also affirms all of the pioneering work that we have completed to get to this turning point in our corporate history. This moment of success is included in our early dedication to build a strong intellectual property portfolio, development of the manufacturing processes for injectable collagenase and strong clinical trial results.

Our work on Peyronie's also led to the relationship with Auxilium, which has resulted in growing commercial success. When we first started developing injectable collagenase, Peyronie's disease was in early focus as the condition that would greatly benefit from collagenase therapy. It's a disease that causes penile deformity from collagen build up but also one that causes pain and emotional distress.

We are eager to help a growing patient population who has we've been told by key opinion leaders has been waiting for a non-surgical treatment with specifically and psychologically damaging disease. These patients have a natural aversion to penile surgery and physicians have become dissatisfied with surgical outcomes. So the more invasive procedures are rarely done. Most patients offer treatment with oral or tropical medications and these have been unproven. The label covers XIAFLEX as a treatment for men with a palpable plaque and curvature of 30 degrees or greater at the start of therapy. Injections are administered in the office and each patient could receive up to eight injections of four treatment cycles of two injections each.

In the Phase III IMPRESS trails trial that led to the approval of XIAFLEX in Peyronie's disease, 90% of patients received six vials or more. Dupuytren's contracture patients received 1.1 vials on average. The product became available to patients in January. As reported by Auxilium last week, during their earnings call, the launch strategy was very focused. They provided several metrics, which are current as of February 20, to demonstrate launch progress. They initially targeted the 400 or so physicians to perform 90% of current surgeries for Peyronie's disease.

As part of the Risk Evaluation and Mitigation Strategy or REMS program required by the FDA, physicians must be certified to offer XIAFLEX. Approximately 225 or 80% of these top target physicians have been certified that 452 physicians across 249 sites have been certified in total.

Auxilium also reported success in terms of patients receiving pre-authorization from their insurance companies as initiated by the Auxilium Advantage program. So far 827 patients with Peyronie's disease have submitted claims and of these only 41 have been denied. 68% of the claims are still being processed and that means well of the 32% where decision has been made 84% have been approved.

Overall the launch is in it is initial stages, but we are encouraged by the progress today. Auxilium's marketing partner for XIAPEX in Eurasia and the Africa is expected to submit a marketing authorization application to the European medicines agencies for XIAPEX for the treatment of Peyronie's disease and we look forward to the potential European approval.

Now, moving on to updates on XIAFLEX in Dupuytren's contracture, the first indication of which CCH was approved for commercial use. Regarding the potential label expansion, Auxilium received FDA acceptance for the FPLA for potential label expansion of XIAFLEX, which would allow for the concurrent treatment of multiple Dupuytren's contracture cords. We expect a decision on FPLA later this year with the PUDFA date set for October 20, 2014. The submission of the FPLA was based on positive results announced in November 2013 from the open label Phase IIIb MULTICORD study showing comparable improvements with concurrent injection in multiple Dupuytren's contracture cords to a single injection across many clinical parameters including joint contracture and range of motion.

We expect that the label expansion will broaden the reach of XIAFLEX and this indication since 35% to 40% of Dupuytren's contracture surgeries in the U.S. are performed to treat two or more cords concurrently.

Auxilium continued to report positive growth of XIAFLEX for Dupuytren's contracture. Vials sales increased 15% over 2012 to 20,000 vials sold in 2013. Additionally, U.S. net revenues reached $62.5 million in 2013, which is a 13% increase over the previous year in 2012. Overall, XIAFLEX market share in the U.S. with all procedures for Dupuytren's contracture has reached 27%.

A final note on the commercial front we were pleased to see that the international revenues of XIAFLEX marketed by Sobi grew 66% over 2012 to 17.6 million in 2013. In addition, to our commercial successes, the vast potential of CCH was further demonstrated in 2013 through progress in the pipeline. We've reported data from our own pipeline programs with CCH and Auxilium advancement pipeline programs, which they manage to the next stages of development.

We were excited to report in December that Auxilium dosed the first patient in a Phase IIb study of CCH with a potential treatment of frozen shoulder syndrome. We also previously announced that the first patient was dosed in the Phase IIa study of CCH for the potential treatment of cellulite being managed by Auxilium. Top-line data for both of these trails are expected in the first quarter of 2015.

The double-blind placebo controlled Phase IIb study for frozen shoulders were rolling as expected. Frozen shoulder a clinical syndrome of pain and decreased motion prevents a large market opportunity given a significant prevalence affecting in an estimated 20 million to 50 million people worldwide. The trial is expected to enroll approximately 300 adult men and women across 35 sites in the U.S. and Australia who will be randomized three to one to receive CCH or placebo. And each patient will be expected to perform whole shoulder exercises after the first injection regardless of treatment group.

Last week Auxilium reported that the cellulite trial was enrolling ahead of schedule. The double-blind placebo controlled Phase IIa study is expected to enroll approximately 144 women who will be randomized to receive up to three treatment cycles of low, medium or high dose CCH or placebo up to three weeks apart. Cellulite is a very common condition causing surface dimpling on the skin due to loss of the elasticity of collagen cords. They're currently no FDA approved pharmaceutical therapies for this condition. So we are excited about the potential large opportunity, market opportunity in this indication, which has been reported to affect 85% to 98% of women.

We like now to touch on recent progress and upcoming milestones in the pipeline programs we are managing for the development of CCH to which Auxilium has the option to license development and marketing rights. First we would like to provide an update on our more advanced studies for lipomas or encapsulated fat deposits often detected as bulges under the skin, which we recently reported data from in both the human and canine lipoma indications.

Human lipomas affect 2% of total human population with more than 575,000 diagnoses each year in the U.S. Data were reported from our open-label signal-center dose escalation study in January 2014. The primary efficacy outcome of the active reduction of the visible surface area of the lipoma as measured by caliper was met combining all patients with the P value of less than 0.001. Data also showed that the patients in the highest dose group which was 75% to the current commercial dose of XIAFLEX achieved the best efficacy results with an average of 67% reduction of lipoma visible surface area and measured by caliper at six months post-treatment.

There were no drug related serious adverse events reported during the trial. We plan to initiate a placebo controlled study in this indication in the first half of 2014.

For Chien-804, the placebo controlled double-blind randomized Phase II trial of CCH and canine lipomas; the primary endpoint of a post-treatment difference in the mean percent change in lipoma volume by CT scan was not met. Yet an analysis among those dogs whose lipomas decreased by 50% showed a statistically significant difference of 50% or more and 47.4% of CCH treated dogs of the visible surface area as mentioned by caliper compared to 5.9% of placebo treated dogs. We are finalizing the full study report and expect to have it completed later this month to submit to Auxilium and trigger the 120-day opting period to license rights in this indication.

We continue to expand behind the broad potential of CCH in many indications. So we're particularly enthusiastic in 2013 to discuss a promising new indication to our pipeline development. We've reported data from a preclinical uterine fibroid study that we are sponsoring with Duke Medicine. Uterine fibroids are the most frequent cause for hysterectomy in the U.S. and it is estimated to cost up to $34 billion in annual costs in the United States. The preclinical data show that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. The stiffness or rigidity has been indicated as a cause of the morbidity associated with uterine fibroids. We are continuing with preclinical studies and expect to report more data in the second quarter of 2014.

With that, I will now review our financial results of the fourth quarter and full year 2013. In this morning's press release we reported a net income of $1.7 million for the fourth quarter of 2013, or $0.27 per basic share and $0.25 per diluted share compared to a net income of $1.1 million or $0.17 per basic share and $0.16 per diluted share for the same period in 2012.

For the full year ended December 31, 2013, we reported net income of $5.3 million, or $0.83 per share on a basic and $0.76 per share on a fully diluted basis, compared to net income of $3 million or $0.47 per basic share and $0.43 per share on a fully diluted basis in the same period in 2012.

Total revenue for the fourth quarter of 2013 was $4.1 million compared to $3.5 million for the same period in 2012. For the full year ended December 31, 2013, total revenue was $14.5 million compared to $11.1 million in the same period in 2012.

Royalty and mark-up on cost of goods sold for the fourth quarter of 2013 were $2 million compared to royalty and mark-up on cost of goods sold and earn out revenues of $2.5 million for the same period in 2012. Royalty and mark-up on cost of goods sold revenues recognized under our agreement with Auxilium for the fourth quarter of 2013 were $2 million compared to $1.6 million for the same period in 2012. Total royalty mark-up on cost of goods sold and earn out revenues for the year ended December 31, 2013, increased to $11.8 million as compared to $9.2 million in the same period in 2012.

Total licensing fees, consisting of licensing and sublicensing fees and milestones, for the year ended December 31, 2013, were $2.7 million compared to $2 million in the same period in 2012. Licensing fees recognized from Auxilium for the full year of 2013 were $0.6 million compared to $0.4 million in the same year in 2012. In 2013, we recognized licensing fees of $0.5 million related to the exercise by Auxilium of its exclusive options to expand the field of its license for CCH to include the potential treatment of adult patients with cellulites and licensing fees of $0.1 million related to development. Sublicensing fees recognized for the full year ending December 31, 2013, were zero compared to $0.6 million in the same period in 2012.

Milestone revenue recognized for the year ended December 31, 2013, were $2 million, compared to $1 million in 2012. In 2013, we recognized the $2 million milestone related to the FDA approval of XIAFLEX for the treatment of Peyronie's disease. In addition, a $29,000 milestone was recognized in the 2013 period related to product approval for XIAFLEX in the treatment of Dupuytren's contracture in Australia granted to Actelion.

Research and development expenses for the fourth quarter of 2013 were $0.4 million, compared to $0.3 million in the same period in 2012. For the year ended December 31, 2013, research and development expenses were $1.5 million, compared to $1.2 million in the same period in 2012.

General and administrative expenses for the fourth quarter of 2013 were $1.1 million, compared to $1.2 million for the same period in 2012. For the year ended December 31, 2013, general and administrative expenses were $5 million, compared to $4.8 million in the same period in 2012.

Income tax expenses for the fourth quarter of 2013 were $0.9 million, as compared to $1 million for the same period in 2012. For the year ended December 31, 2013, income tax expense was $2.7 million as compared to $2.2 million in the same period of 2012.

As of December 31, 2013, we had cash and cash equivalents and investments of $12.6 million, compared to $11.3 million on September 30, 2013.

Before we turn the call over for questions, I would like to reiterate the many exciting milestones we reached in 2013 and what we can expect in 2014 by advancing these programs further.

Regarding our all proprietary development programs we've reported top-line data for both of our Phase II trials in human and canine lipomas. We will initiate a placebo controlled trial in human lipomas in the first half of 2014. For canine lipoma, we will finish the final study reporting to trigger the 120-day opt-in period from Auxilium to license rights to this indication.

Additionally, we are continuing preclinical studies of CCH and uterine fibroid tissue and expect to report more data on this in the second quarter of 2014. Auxilium dosed the first patient in its Phase IIa study of CCH in cellulites and a Phase II B study of CCH in frozen shoulder. We expect to report top-line data from both studies in the first quarter of 2015.

In commercial indications, we look forward to the PUDFA date of October 20, 2014, when the FDA is expected to make a decision on the FPLA submitted by Auxilium seeking a label expansion to include concurrent injections of XIAFLEX into multiple Dupuytren's contracture cords.

And lastly, we look forward to reporting more progress on the XIAFLEX launch in Peyronie's disease in the coming quarters and to submit -- Sobi is submitting a marketing authorization application for approval in the EU in this indication.

And now, I would like to open up the call for your questions. Operator?

Question-and-Answer Session

Operator

(Operator Instructions) And the first question will come from Joel Sendek of Stifel. Please go ahead.

Joel Sendek - Stifel

Thanks for the overview, Tom. So I have two questions. In listening to the Auxilium call there was some discussion about what the backlog was or the sales so far for XIAFLEX in Peyronie's and people suggested $20 million, $21 million, I'm wondering if you can comment on that. And then, with regard to the lipoma indication, I'm wondering what the strategy will be if Auxilium chooses not to exercise the option? Thanks.

Tom Wegman

So first question was I guess related to some of the dialogue that was going on about the backlog there.

Joel Sendek - Stifel

Right.

Tom Wegman

And one of the analysts did some quick map and calculated $21 million. I like to note and look I have great faith in this product going forward. I was particularly encouraged by the fact that 827 patients have already signed on for the insurance -- to go through the insurance system, so I think that was quite encouraging, and it should bode well for the future. So overall, I'm quite encouraged. And as I said the number of years and it's not lot that that patients are very anxious for this type of therapy. So I think it's a really encouraging start. Joel, could you repeat your second question?

Joel Sendek - Stifel

Sure. So and just to sum up what you just about this. So effectively the math wasn't wrong there is what we should interpret with regard to that range of around $20 million or so?

Tom Wegman

I think the math -- the math which you do is -- I would just -- I would call it encouraging. I think I was waiting for Auxilium to affirm that that was correct. But I would say it's very encouraging. And certainly with the 827 patients are an indication of what's going to go forward. We really have an excellent product here. So that could certainly exceed what we're seeing for Dupuytren's. But let me reserve judgment until I see actual sales numbers.

Joel Sendek - Stifel

And then, I have a question on the lipoma indication obviously, Auxilium once said 120-day windows trigger we will make a decision. I'm wondering obviously they couldn't license it; if they don't what you intend to do with the -- with that asset or the rights there?

Tom Wegman

Yes, well I think it would provide a really interesting opportunity here depending on Auxilium's attitude on this. And I don't think -- I think Auxilium is not setup it's a veterinary marketing organization. So I think if they were -- either turndown the indication or we could come to some agreement with them, I think there would be some great opportunities for partnering with some of the new companies and some of the established companies in the veterinary field, I mean particularly, companion animal field has become a hot buy -- a hot area as most of you know and I think will be great opportunity for us.

Joel Sendek - Stifel

Would that could be even more lucrative if they turn it down or is it the reserving judgment on that?

Tom Wegman

If we had it to ourselves I think it would be a great opportunity -- we will do add -- would give us more latitude.

Operator

Our next question is from Ram Selvaraju of Aegis Capital. Please go ahead.

Ram Selvaraju - Aegis Capital

Just a few financial housekeeping items. You indicted that you should be receiving a milestone payment from DSP of about $3.5 million, is that correct?

Tom Wegman

That's correct.

Ram Selvaraju - Aegis Capital

Can you just clarify how you're planning to account for the receipt of this milestone damage? And then, also if you could, give us some more color on when you anticipate the payment of a milestone associated with the approval of XIAFLEX in Peyronie's disease or if you have already received that and how large that milestone is likely to be?

Tom Wegman

No, that's fine. And actually Pat -- Pat Caldwell is here and he may actually speak to that question. So I'm to let Pat for those two.

Pat Caldwell

Hello. So the first question the DSP payment of $3.5 million is not actually a milestone. That actually is the payment earn out royalties that we already recognized in 2013. So under the agreement we actually received the payment 90 days later from the actual revenue recognized during the year. So that revenue has already been recognized.

The payment for Peyronie's, the milestone we recognized in December of 2013, with the approval and that was actually $2 million.

Ram Selvaraju - Aegis Capital

So you're saying that with the impact of both of those milestones we should probably expect end of first quarter cash number of around $16 million, does that sound correct?

Pat Caldwell

Yes, so you can see in our press release the accounts receivable balance is somewhere approximately $5 million. So yes, by the end of March we expect that to be recognized. Actually the $2 million came in for Peyronie's we've already received in December.

Ram Selvaraju - Aegis Capital

Right.

Pat Caldwell

Of cash balance.

Ram Selvaraju - Aegis Capital

Just a couple of questions about R&D if I may. So Tom you had indicated that the Phase IIA placebo controlled lipoma study is likely to start at the first half. Can you give us a better idea as to when in the first half is it likely to come is the early part? I mean we're already almost through the first quarter. So should we anticipate that a bulk of the expenditures associated with the startup cost of that trial should hit your R&D line in the second quarter? That accordingly the R&D expenditures in the second quarter are likely to be higher than they are in the first quarter. And then can you give us an idea of when you anticipate enrollment in that study to complete and when you anticipate potentially reporting data from that study. And then finally with respect to the canine lipoma front, if Auxilium does not opt in, are you anticipating doing additional proof of concept clinical work here in dogs or would you look to license out the rights to CCH in canine lipomas without doing additional clinical work. Thank you.

Tom Wegman

Okay. Those are good questions. I think a little bit -- I think they still have a real handle on how the enrolment is going to go. I think it's probably, we've already said that we anticipate all the patients will be enrolled by the fourth quarter. So I think a little bit the extent is they're going to be probably a little bit later rather than earlier. Just remember that this not going to be a very big trial. What we're lucky about is that that it's very effective product and placebo has -- there has been no indication that placebo should do anything for lipoma. So I believe we could a small patient trial around 20 patients we really would have this been nailed. Of course, we need to go through -- we still have to work real issues with FDA but this shouldn't be a problem. We're very, very encouraged by the work we've seen so far.

In terms of the development for canine lipomas I think those are -- that's an evolving area, I think we'll have to waive what other work -- may be get a better feel let's say Auxilium, we express is now IMPRESS. Well, I think it's a little bit better feel for what FDA would like to see in order for me to give a better hand. So I think I could be in a better position after we've settled the first thing, what Auxilium's level of interest and then may be have some -- some more interaction with center for veterinary medicine then I could give better, a more cogent answer on that one.

Ram Selvaraju - Aegis Capital

Last question if I may; if we look at the potential for XIAFLEX outside of the United States have either Sobi or Actelion given any formal guidance as to what they expect for sale with the products in those ex-US geographies where they hold the rights over the course of 2014 or we sighing blind here?

Tom Wegman

Unfortunately, they don't give a lot of guidance there. If it's some of their meetings and it's a little frustrating. So all the information I get is through Actelion but I -- when I say about Actelion I saw a nice increase, which we just mentioned in our talk from Sobi, so I got my fingers crossed that they'll be a good partner and be able to penetrate well into Europe.

Ram Selvaraju - Aegis Capital

Very quickly, a financial housekeeping item. Do you anticipate any significant increases in G&A expense for 2014 or should we expect 2014 G&A spending to look more or less the same as it did in 2013?

Tom Wegman

I think it's pretty good to be pretty close. I'm not, as you know, we're now only five employees, I'm not hiring, I'm not on an empire building spree here. So we're good -- we're going to remain brutal.

Operator

(Operator Instructions) We're showing no further questions. This will conclude our question-and-answer session. I would like to turn the conference back over to Tom Wegman for any closing remarks.

Tom Wegman

Okay. Well, I thank everyone for attending and I appreciate all the questions and the continued interest in BioSpecifics thanks again.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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