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Sonoma Pharmaceuticals, Inc. (SNOA)

Q1 2016 Earnings Call· Thu, Jul 30, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Oculus Innovative Sciences’ Fiscal First Quarter 2016 Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I will now like to turn the conference over Mr. Dan McFadden. Please begin.

Dan McFadden

Analyst

Thanks, Abigail, good afternoon and thank you for joining us. With me on the call today our CEO, Jim Schutz; and our CFO, COO, Bob Miller, we will open the call with Bob's review of our financial results for the quarter, followed by Jim's update on our business strategy moving forward. This afternoon Oculus issued a press release detailing fiscal first quarter 2016 financial results and recent corporate developments. A copy of the release can be downloaded from our Web site, which is at oculusis.com, that’s oculusis.com or you can call Investor Relations at (425) 753-2105 and we’ll be happy to assist you. I'll remind listeners that this conference call contains forward-looking statements within the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are identified by use of words such as expect, to expand, would, and anticipate, among others. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially, including risks inherent in the development and commercialization of potential products, the risks that potential clinical studies or trials will not proceed as anticipated or may not be successful or sufficient to meet regulatory standards or receive the regulatory clearance or approvals as well as the Company's future capital needs and its ability to obtain additional funding and other risks detailed from time-to-time in the Company’s filings with the Securities and Exchange Commission including the quarterly report on Form 10-Q and the annual report on Form 10-K. Identified product applications and/or uses are intended to highlight potential applications for the investment community and does not infer that the Company is marketing for these indications. The Company does not provide any assurances that such applications will receive regulatory approvals. Oculus disclaims any obligation to update these forward-looking statements. So with that, I will now turn the call over to Bob Miller, our CFO.

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

Thank you, Dan. I'll first discus the financial presentation of our businesses secondly our key strategies to achieve strong revenue growth for fiscal year 2016; then summarize our financial results for the first quarter fiscal year 2016, and lastly we’ll provide some revenue growth guidelines for quarter ending September 2015. First of all, we have changed the detailed financial presentation of our businesses compared to last year by separating product revenues which are shown on the last page of the press release into two categories, one, revenue from direct product sales, and two, revenue in the form of product licensing on royalty fees. For instance, all of our revenue related to our former partner Innovacyn in animal health care is a royalty. This provides more transparency on the true sales growth of our continuing products in various geographic areas especially as we focus on growing sales in U.S. with our direct sales force. Secondly, what are our key strategies to ignite revenue growth for fiscal year 2016, our key strategies for the growth for the rest of the fiscal year have not changed since detailed in the last earnings call and they are the following. Number one strategy is to focus on growing revenue in U.S. dermatology market with our direct sales force and a robust product pipeline. The U.S. derm segment provides us with the largest long-term growth potential and will lead us in the overall breakeven. Our second strategy is to continue strong unit growth in our international business with new product launches and stronger partners. The international segment is 73% of our product revenue and will give us the largest dollar growth and furthermore generates cash to help us fund the U.S. derm growth. The objective of these two strategies is to achieve strong unit growth for…

Jim Schutz

Analyst · Jason Kolbert with Maxim. Your line is open

Thank you, Bob. I will cover two topics in the next six minutes or so. First, a quick look back for our new shareholders on why we pick U.S. dermatology and plastics as our core market. Second, provide an update on our progress toward implementing our strategic plan and finally then open the call up for Q&A. For first a quick look back, when Bob and I took over the range here at Oculus in the spring of 2013, our market capital was approximately 16 million and as we've said before we were a mile wide and an inch deep various therapeutic areas and high depended upon the performance of our partner sales efforts. With the new Board of Directors, we hunkered down to study our various therapeutic opportunities pick one and own it with advice from the board. After several month of homework, we handpicked derm and plastics in the U.S. as our core market and classified all international animal health and acute care sales as non-core. So why did we picked derm and plastics as our core market. As David Steinberg, Managing Director of Equity Research at Jefferies phrased it, U.S. dermatology products have several general attributes worthy of note. One, shorter development timelines; two, lower clinical trial cost; three, lower regulatory hurdles; four, high cash pay component especially for the aesthetic products; five, our recent track record of success and six, our really active M&A market which Mr. Steinberg describes as a second way for shareholders to roll. Bob and I understated that derm and plastics also have the following attractive attributes doting on Mr. Steinberg comment. Seven, derm has strong pricing, product margin and insurance coverage; eight, it’s the concentrated call point, meaning companies like our size don’t need them enormous sales force to cover; nine,…

Operator

Operator

[Operator Instructions] Our first question from the line of Jason Kolbert with Maxim. Your line is open.

Jason McCarthy

Analyst · Jason Kolbert with Maxim. Your line is open

Hi, guys, it's actually Jason McCarthy. Jason Kolbert is traveling in New Zealand for the past few weeks. Well, congratulations, sounds like everything is going really well and I kind of touched on this when we spoke last, while the Company is focused on commercial ramp and driving the launch of products that it has now, I kind of want to expand on additional indications. And if you could talk about maybe the potential of using hypochlorous acid or Microcyn for the treatment of moderate to severe acne, and I asked this because it seems like a bridge to acne in the label wouldn't be terribly difficult maybe you could tell me what it takes to do that bridge, and the point is that adding acne as a very attractive indication that could result in very rapid uptake particularly by teens who don't want to take prescription for it.

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

So I guess we agree with you, that we actually have had a study done, head-to-head against benzoyl peroxide using our Microcyn technology and it gave good results against benzoyl peroxide which is you know that the product is used by most people. For us the go to step that you were talking about, we would obviously in the United States want to do a principal study small study just to reconfirm everything and then you need to look at phase I, II. We're looking at it but our first step is to be established our platform in the derm medical device side and get a good strong platform and get to the point where we're getting closer to breakeven before we head too far down that other path and there are a number of steps before we get to the Phase I, II and looking acne, but it's a very interesting opportunistic that we would look at I guess.

Jason McCarthy

Analyst · Jason Kolbert with Maxim. Your line is open

Okay and could you just remind or walk us through how many reps you have in your U.S. and how many derms are you calling on other particular areas that you're more focused on that would use the product like Microcyn or Microcyn based product more than others?

Jim Schutz

Analyst · Jason Kolbert with Maxim. Your line is open

James speaking, out total US sales force is 20 outside reps, 9 inside sales people, 14 dedicated to dermatology, typical call point our Hepni [ph] prescription writers because the data is available both through IMS or [indiscernible]. You can tell Bob is fighting a cold so excuse us, it's not terribly difficult to get heavy TRX writers through IMS data, so frankly that's where we placed our 14 derm specific sales reps. So it’s in territories where those heavy prescription writers were easy for us to study through IMS data.

Operator

Operator

Thank you. Our next question comes from the line of Dan Chang with Stonegate. Your line is open.

Dan Chang

Analyst · Dan Chang with Stonegate. Your line is open

Talking about when I think Jim you've mentioned adding more sales reps, I was wondering how much that’s going to add on to SG&A for the next year?

Jim Schutz

Analyst · Dan Chang with Stonegate. Your line is open

Okay, our sales reps are fully loaded cost about the 40K per quarter, 160K year. But generally we would like before we take on new, once we like to get the current ones closer to breakeven and so that would be our first step. And then we would look at it in 2 to 4 at that point.

Dan Chang

Analyst · Dan Chang with Stonegate. Your line is open

Okay.

Jim Schutz

Analyst · Dan Chang with Stonegate. Your line is open

So we would be doing it relatively slowly so that's not a huge cash out flow sink for us and specially when we're starting with really good set of products that they can sell right off the bat then it enables them -- their sales ramp to go up even faster.

Dan Chang

Analyst · Dan Chang with Stonegate. Your line is open

Okay and you’ve mentioned you guys are going to be launching one new product per quarter, is it?

Jim Schutz

Analyst · Dan Chang with Stonegate. Your line is open

That is our target, yes.

Dan Chang

Analyst · Dan Chang with Stonegate. Your line is open

Okay and that's about you looking at a new indication, are you looking at different dosages just kind of what I am wondering?

Bob Miller

Analyst · Dan Chang with Stonegate. Your line is open

For the quarter ending September 30th, the new product has already been announced. I believe it’s SG we did the loading to the pick free distributors to [indiscernible], Cardinal at the very-very end of June, it will be in the sales force bag fully trained in three weeks or so. For the quarter ending December stay tuned in, we'd be glad to share what we're working on, but to answer your question we're looking at both new indications and new dosage and delivery forms of the current active.

Dan Chang

Analyst · Dan Chang with Stonegate. Your line is open

And kind of my last question, you've talked about an active M&A market, Jim, are you guys looking at any potential targets? Is there anything that’s strategic or do you guys or do you guys think most of the growth is going to come organically in the next couple of years?

Bob Miller

Analyst · Dan Chang with Stonegate. Your line is open

Well we have a terrific R&D department that’s created a nice pipeline of product. So the organic growth is attracted Dan. You probably remember that the Board tapped me on the shoulder because I am an attorney by training with an M&A background. I think to really understand our market here in the States you have to be constantly looking and listening. So we’re certainly paying attention to derm and plastics in the state but no promises or timelines on any M&A activity.

Operator

Operator

Our next question comes from the line of Keith Zdrowak with National Securities. Your line is open.

Keith Zdrowak

Analyst · Keith Zdrowak with National Securities. Your line is open

I had three questions for you. First question is, so in the month of June you have an FDA approval, just curious if we have any other potential FDA type scenarios you guys are working on over the next six to 12 months, you’re hoping for any more approvals? Next question would be, in Alevicyn [ph] I believe what is about $2 million in revenues a year that you loss with Alevicyn, I know you have new veterinary partner. Do we at some point see some of that getting gained back by the new partner or partners that you might have down the road and if so can you give a time frame? And then the third question would be the revenues appear to be starting to move in the right direction again, 4 million the prior quarter, 3.7 this. If we continue to see the growth coming in, do you think calendar year 2016, calendar year, do you think it would be crazy if you guys average about 4.5 million per quarter next year and the calendar year?

Jim Schutz

Analyst · Keith Zdrowak with National Securities. Your line is open

We took quite note, so I’ll handle one, Bob you handle two and three. So my notes on question one expected FDA approvals in the next six to 12 months, I think we’ve been and sure publicly Keith we’ve got a very interesting barrier skin repair product queued up in the FDA queue, not sure we had given a timeline on when we expect an FDA response, conservatively we like to wait for first correspondence with the FDA before we talk too much more about this, so bear with us. Until we hear more from the FDA we’ll stay a little bit quiet on that. Second product that I think we shared with the street was several dermatitis product that we’re very enthusiastic about it. But I think same thing, same answer we’ll share more after we get feedback from the FDA. So hope we have answered your first part, I think the second question Keith that was how soon do we expect to see our own animal health revenue rolling in.

Bob Miller

Analyst · Keith Zdrowak with National Securities. Your line is open

We have seen revenue already, but it's not been a large number it seems to be growing, we’ve set up a lot of the distribution capability at this point especially in the pet area. We are in a number of accounts at this point. We are making good progress and we will expect that we will start to see some revenue growth come out that area.

Jim Schutz

Analyst · Keith Zdrowak with National Securities. Your line is open

Third question we have if I got -- if I know is accurate, revenues moving in the right direction in calendar 2016, do we expect to achieve 4.5 million in quarterly revenue.

Bob Miller

Analyst · Keith Zdrowak with National Securities. Your line is open

We don’t really give that kind of guideline at this point, what we have said is that we would expect to see double-digit revenue growth for our fiscal year and this year in fact, if you do the math it gets pretty close to it what you're talking about actually. But we don’t formally give any guidance other than the general. For the year we did give guidance as you noticed for the quarter ending September just because people seemed to be very interested and trying to figure out whether the trend was going to continue in terms of our quarter growth compared to last year for the next quarter. So we are encouraged that we would be able to get to those the levels we were talking about.

Operator

Operator

Our next question comes from the line of [indiscernible]. Your line is open.

Unidentified Analyst

Analyst

According to and I am new to this story so it maybe you guys haven’t updated data, but Bloomberg was expecting 4 million in revenue this quarter was that analytical coverage it wasn’t updated or were you that far off on your revenue?

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

We have four analyst who cover us, we throw Zax [ph] and Zax doesn’t give our revenue number, but the other three do and we think we’re right in the middle of consensus, quite we’re not sure where Bloomberg got their 4 million for the three group paying attention, we’re right in the middle.

Unidentified Analyst

Analyst

Okay so the atopic dermatitis total market share, total addressable market is what?

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

It's in the -- there are about 13.5 million scripts we identified that relate to atopic dermatitis market at our price which -- our prices tend to range anywhere from $40 to $80 for product. So where if we’re on a conservative basis you could put us in $500 million category as an addressable market. Now substantial amount of that market and as Jim talked about this on the last earnings call, this is a steroid product which -- they're very good in terms of reducing inflation, they're pretty good in terms of reducing itch, but they have a lot of safety issues. And we think that we got very competitive product with them, specifically on the safety side.

Unidentified Analyst

Analyst

And so how you're measuring yourself in terms of taking share, how do you -- what kind of metric you're using quarter-on-quarter?

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

When you're talking about 13.5 million scripts, we're just a sliver of that at this point. So even if we got 10% of that market, we would be pretty darned successful.

Unidentified Analyst

Analyst

Then why wouldn't it be more?

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

We would like it to be more, but we'll start out with 10 for the next -- 10% of that market.

Unidentified Analyst

Analyst

When you hit that 10%?

Bob Miller

Analyst · Jason Kolbert with Maxim. Your line is open

We don't really provide the guidance on that at this point.

Jim Schutz

Analyst · Jason Kolbert with Maxim. Your line is open

But we will be enthusiastic on adding additional headcount. We can see exactly through ISM data where we want to add the new sales reps. As Bob said, they already have terrific products into the bag waiting for them. We're just waiting the fall to pull the trigger and continue to add, add, add as cash permits.

Unidentified Analyst

Analyst

And on your medical, do you have any medical advisory board that's promoting your products, dermatologist?

Jim Schutz

Analyst · Jason Kolbert with Maxim. Your line is open

Yes, we do have medical and clinical dermatology focus group, but they certainly do not promote our products. They mostly advise us on industry churns, clinical trial that could be significant to us, no way should they promote on be our behalf.

Operator

Operator

Thank you. Your next question comes from the line of Terrence Mayer with Private Investor. Your line is open.

Terrence Mayer

Analyst · Terrence Mayer with Private Investor. Your line is open

I think all of my questions were addressed by the previous caller, so I guess I'll just look for some of the things that we've spoken about too to inspire over the next quarter?

Jim Schutz

Analyst · Terrence Mayer with Private Investor. Your line is open

Thank you, Terrence.

Terrence Mayer

Analyst · Terrence Mayer with Private Investor. Your line is open

You're welcome thank you.

Operator

Operator

Thank you. Our next question comes from the line of Bob Robin, Robins Capital. Your line is open.

Bob Robin

Analyst · Bob Robin, Robins Capital. Your line is open

Question on more strategic bigger picture that you see for the animal healthcare market, how attractive is it after this prices as you're overcoming with Innovacyn and Vetericyn and whatever, how attractive might it be in terms of re-penetrating what was as I recall half the entire U.S. market was penetrated by Innovacyn and what about margins, how attracted is it to emphasize this market versus your other opportunities, margins being effected what I am seeing I think is about $10 less pricing for 16 ounce bottle of Microcyn animal healthcare versus the Vetericyn formerly?

Bob Miller

Analyst · Bob Robin, Robins Capital. Your line is open

Great question, so two prompt, do you reference to Jim, do you want to answer it?

Jim Schutz

Analyst · Bob Robin, Robins Capital. Your line is open

Okay, I'll take the first. We actually happened to have key driver for our animal health efforts on the phone with us, but I'll do the talking and perhaps Dan you can interrupt me. I think our animal health opportunity Bob as you pointed out was really created through the branding efforts of our former partner and one-to-punch, terrific products coming out of our R&D department. Our real challenge in reigniting our animal health sales is in the brand in that step one because those same high quality efficacious products are still coming out of our R&D department. So the challenge as Dan would probably put much more specifically is to dig into our former partner’s revenue stream with our high quality best-in-class products. Bob Millar, you probably the better one to answer the animal health margins question.

Bob Miller

Analyst · Bob Robin, Robins Capital. Your line is open

Yes.

Jim Schutz

Analyst · Bob Robin, Robins Capital. Your line is open

It's a great question.

Bob Miller

Analyst · Bob Robin, Robins Capital. Your line is open

Yes, there is no question that and one of the reasons as Jim walked through why we would pick derm, we've been in the animal health market, we have a partner, we're in it now, we have new partners. The products we might get -- our margin would be lucky to be in the 50% to 60% margins on the animal health care area and in the derm area where you will be generally 75% to 85% margins. Because of the pricing is gone, there is a huge pricing differential between our derm prescription markets where we’re selling products anywhere from $40 to $80 per product, where some of our competitors are actually selling products for $200 versus the animal healthcare where when you go in the store you're buying it for $20 to $30. But that means that includes a 50% mark up for the pet store and 30% mark up for the wholesaler, the distributor and the margins to somebody like ourselves or much smaller. So there is no question that the derm business is the one that we’re going to focus on and where we’re going to put our money.

Bob Robin

Analyst · Bob Robin, Robins Capital. Your line is open

About the margin penetration question, you expect to recapture the market-share that you once have?

Jim Schutz

Analyst · Bob Robin, Robins Capital. Your line is open

[Multiple speakers] We’re certainly not going to -- go ahead I’m interrupting u Bob.

Bob Robin

Analyst · Bob Robin, Robins Capital. Your line is open

That’s alright, in the U.S. pet store market and perhaps veterinary stores I think you had over 50% saturation of the marketplace in the U.S. and of course that’s gone way down, are you thinking is attractive enough to recapture that?

Jim Schutz

Analyst · Bob Robin, Robins Capital. Your line is open

Well certainly it's an attractive market, but as Bob mentioned we think we rather spend money on building on dermatology brand given those product margins. That having been said, Dan and team have partnered with industry experts headquartered here in California and expect more news in the not too distant future on adding more terrific partners there to help guidance to recapture that market-share you just described Bob.

Operator

Operator

[Operator Instructions] I am not showing any further questions at this time. I would like to turn the call back to management for further remarks.

Jim Schutz

Analyst · Jason Kolbert with Maxim. Your line is open

Thanks so much for joining us today and we look forward to talking to you next quarter.