BioPharmX Corporation (NYSEMKT:BPMX)
Q1 2016 Earnings Conference Call
April 26, 2016 04:30 PM ET
Mike Miller - IR
Anja Krammer - President
Jim Pekarsky - CEO
Greg Kitchener - CFO
Anthony Vendetti - Maxim Group
Ramakanth Swayampakula - H.C. Wainwright
Good day, ladies and gentlemen and welcome to the BioPharmX Fourth Quarter and Full Year Earnings Conference Call for the fiscal year ended January 31, 2016. At this time all participants are in a listen-only mode. Later after management provides its prepared remarks we will conduct the question-and-answer session. Please note this conference is being recorded.
I would now like to introduce your host for this conference call Mike Miller, Investor Relations. You may begin.
Thank you, Laura. This is Mike Miller with Amato and Partners Investor Relations. Thanks for participating in today's call. Joining me from BioPharmX is Founding Chairman, Chief Executive Officer, Jim Pekarsky; President and Co-Founder Anja Krammer and Chief Financial Officer, Greg Kitchener.
Earlier today BioPharmX released financial results for the fourth quarter and the fiscal year ended January 31, 2016. If you have not receive this news release or if you would like to be added to the company's distribution list, please send an email to email@example.com. Today's conference call is being broadcast live through an audio webcast and webcast replay of the call will be available later today at www.biopharmx.com.
During today's call BioPharmX will make forward-looking statements as to future operating results. Because such statements deal with future events actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in our Annual Report on Form 10-K, Form 10-Q and other filings with the U.S. Securities and Exchange Commission, as well as in today's press release.
The forward-looking statements provided during this call are valid only as of today's date April 26, 2016 and BioPharmX assumes no obligation to publicly update these forward-looking statements. During the call BioPharmX will discuss non-GAAP financial measures. These non-GAAP measures are not prepared in accordance with Generally Accepted Accounting Principles. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measures can be found in today's press release made available on our website.
With that I’d like to turn the call over to BioPharmX Chairman and Chief Executive Officer, Jim Pekarsky. Jim?
Thanks Mike. Good afternoon and thank you for joining us. BioPharmX is making good progress towards our goal of becoming a leading dermatology specialty pharmaceutical company. We had a very productive fourth quarter and I'm pleased to report that momentum continues for our company. We've achieved the number of important milestones and I will highlight a few of them for you now.
First, we've strengthen and diversified our shareholder base and we are extremely pleased in receiving a direct investment of 5.9 million by Franklin Advisors during the fourth quarter and we raised an additional 4.3 million in the public offering that closed earlier this month. We've gained an important resource through our formulation of a dermatology advisor board, which will provide strategic council as we develop products to address unmet dermatology need. The seven [indiscernible] leaders, who have agreed to serve on this Board bring years of experience in clinical care, academia and research. They’re confidence in BioPharmX’s ability to deliver needs solutions to the dermatology market adds valuable creditability during our development stage.
Last month, we received FDA acceptance of our investigational new drug application to commence Phase 2 clinical trials BPX-01, we’re extremely excited about this unique topical formulation of the proven anti-biotic minocycline and believe if it’s approved, it will be a game changer in the treatment of moderate to severe acne. We also have received approval to conduct the Phase 4 study in the U.S. and Canada for a Violet molecular iodine supplement. In a few moments, our President and Co-Founder on Anja Krammer will give you more detailed update on our clinical trials and our CFO, Greg Kitchener will review the financial results for reported today and we’ll open the call to your questions.
Before I hand the call to Anja. I want to briefly update you on our priority initiatives for the near-term. At the top of this list is to successfully execute our BPX-01 clinical program and complete our Phase 2 clinical trials, which will be used to guide our Phase 3 trial to support product approval. Yesterday, we announced full patient enrollment in the Phase 2a trial. Our plan is to have initial data available by this summer with the goal of commencing a Phase 2b trial in the second half of this year. As a reminder BPX-01 is the one and only stable hydrophilic, topical gel is fully solubilized minocycline. Minocycline is the most prescribe drug for moderate of severe acting and it’s found and products like the oral branded drug Solodyn.
Minocycling is anti-bacterial, anti-inflammatory and has a lower resisting rate than another anti-biotics, oral drugs like Solodyn are very effective at reaching the targeted P. Acnes Strains because they deliver a high concentration of antibiotic throughout the entire body. But because oral delivery and high concentration can cause a number of side effects, dermologist usually for scribe minocycling for a limited time before switching in topic antibiotics that are less effective, but have fewer side effects. Our goal when we selected minocycline was to take the most efficacious ingredient for treating of p. acne and deliver it in a low dose topical form.
Through this novel method of delivery minocycling can attack the bacteria directly and quickly but without systemic side effects. After four years of development and a vast number of formulation revision, we have we have accomplished our goal. We also have remained focused on the development of organic agencies that expand our available market opportunity by leveraging our topical hydrophilic delivery technology allowing for combination therapies as well as additional indications for BPX-01.
We have continued efforts to expand the reach of Violet iodine supplement for existing retail programs as well as through strategic partnership opportunities. Retail availability of the viral product has expand to more than 7,500 locations nationwide and several women’s health companies have expressed interest in partner with BioPharmX on the commercialization of Violet. We are actively evaluating these potential opportunity. In addition to these activities, we also have continue to seek in-organic growth opportunities via licensing and partnerships, while working to build our infrastructure in support of anticipated growth.
And lastly, while still in the R&D phase. We’re exciting about our biologic based product BPX-02, which we believe has potential to address the large unmet need in dermatology. Specifically the $12 billion aesthetics market, we encourage by our progress with BPX-02 and look forward to sharing more information about this product.
In summary, I believe we have succeeded in strengthening BioPharmX financially and operationally since our last quarterly update. We’re continue to make progress with our clinical stage drug candidates and remain confident in there potential to fuel our company’s growth.
I’ll now turn the call over to Anja, who will provide additional data on our acne trials and market development efforts for Violet. Anja?
Thanks Jim. Starting with our therapeutic dermatology delivery solution and our first product in this platform, BPX-01 for the treatment of moderate to severe acne. We’re pleased with the progress to the program and have participated in a series of dermatology conferences and symposia [ph] events throughout the last six months. These events will provide an opportunity to share progress to the delivery system as well as data for first drug candidate from this platform.
For example, at the 2016 winter clinical dermatology conference in Koi, Hawaii, we presented a key abstract of pre-clinical data, it demonstrated how BioPharmX’s unique formulation system for delivering minocycline offers a breakthrough in acne treatment. Because the lowest stomach exposure will likely reduce the systemic toxicities commonly associated with oral administration of the antibiotic. Results from our pre-clinical toxicology studies demonstrate that the systemic exposure and peak plasma concentration of minocycline are minimize by topical administration. Which eliminates the risk of unwanted side effects that may discouraged compliance.
Most topical acne medications available today use less effective antibiotics than minocycline and many are was like CLR core oil based which means they cannot as effectively deliver even the less effective antibiotic into the epidermis and Sebaceous region were acne develops. Our early results have also indicated that lower dose was of the active maybe into provide a treatment with the superior the higher dose topical formulations and safer than oral therapy. More specifically a 1% minocycline dose could work as well as a 4% topical alternatives utilizing the same active therefore reducing the potential side effects.
As Jim mentioned previously we received FDA approval to Commenced Phase 2 clinical trials for BPX-01. This phase will be conducted in two parts. As announced yesterday Phase 2a our first in human study accomplish full enrollment under an IND application and the study is underway. This randomized placebo controlled double blind clinical study will assess effectiveness in reducing the number of acne causing bacteria in study patients after four weeks and evaluate the drug's safety and its tolerability.
It is the single center 30 patients study which will allow us to determine the true difference between BPX-01 and inactive vehicle control in p. acne's reduction. The Phase 2a study will be conducted by Philadelphia based KGL skin center and the principle investigator is Dr. Stuart Lessin, a board certified dermatologist who serves as KGL Medical Director. We expect to complete this first study of the clinical development program for BPX-01 before commencing Phase 2b this summer.
Phase 2b will be a multicenter randomized placebo controlled double blind 12 week three arm dose range finding study with two concentrations of minocycline. Our primary endpoint will be change in inflammatory lesion account, but we will also be looking at overall tolerance to repeated exposure to the topical drug, such as scaling, itching and redness as well as overall improvement as determined by the patient and the clinician. We believe that our 1% concentration in the right dose for that. Phase 2b will confirm the dose, we pick into Phase 3. The difference between active and placebo will also help determine the sample size going into Phase 3. We expect Phase 2b to be completed around calendar 2016 or early 2017 with phase 3 clinical studies commencing around mid-2017.
Additional studies will also include a maximum use of Pharm kinetics study or PK that will compare Pharm kinetic for our topical drug with that an oral administration of marketed oral minocycline products as well as a standard channel of skin centralization and toxicity studies.
Now moving on to our women's health technology. We were pleased by the progress Violet made throughout the quarter and are encouraged by its potential future growth. Recognizing the Violet is a new product category in women's health building the necessary awareness to drive adoption requires a combination of the projects to reach the consumer. As part of the nationwide physician education and awareness building campaign more than 15,000 healthcare providers have been educated on Violet and over 500 offices have been also free sample products and informational or displays along the product information materials. We will continue to reach out for physician communities through various programs to educate the consumer on the benefits of Violet for women that frequently visit their doctors for FBC discomfort.
In March the company announced it had received Institutional Review Board, IRB approval to initiate a Phase 4 study for Violet and in April we also announced that Health Canada had approved the study for our Canadian trial. KB take energize are London, Ontario based clinical research organization focused on its pharmaceutical biotechnology and pharmaceutical product research will conduct the study in the U.S. and in Canada.
The study is randomized double blind and placebo controlled to evaluate the safety, tolerability and potential benefits of violet on breast health in women with cyclical breast pain and tenderness. The planned sample size for this study is a 120 females with approximately 80 subjects receiving Violet and approximately 40 subjects receiving the placebo in a double blind manner. Participants will be instructed to take Violet iodine or placebo daily for six months. Participants receiving placebo in the first study phase will be also three months of Violet iodine at the conclusion of their participation in the six months study period.
Participants will record acceptance daily using a Smartphone app and complete a more in depth on site questionnaire and receive a blood drop prior to the study at three months and again its six months. Results from the study are expected by the end of this year. We will also be able to progress the program for commercialization and partnership in the EU market, under normal regulatory reciprocation guideline. So this will offer us the ability to expand our market reach for Violet. Several women’s health companies have expressed interest to partner with Violet and we are exploring all strategic opportunities to accelerate growth through their established distribution channel.
And with that, I’ll turn it back to Jim. Jim?
Thank you, Anja. Let’s now turn to BioPharmX’s CFO Greg Kitchener for a detail review of our financial highlights. Greg?
Thanks Jim and good afternoon everyone. Starting with our fourth quarter financial results.
Revenue for Violet which we recognize primarily on a sell-through basis increased $35,000 in the fourth quarter from $20,000 in the prior quarter reflecting incremental consumer purchases from both online and retail sales. Total GAAP operating expenses were $4.4 million during the quarter ended January 31, 2016, compared to the $3.3 million during the prior year period. As a result of increased expenders for the company’s acne drug pre-clinical preparation and continued marketing and commercialization efforts for Violet.
GAAP net loss for the fourth quarter was $4.6 million or $0.19 per share, compared to a net loss of $3.6 million or $0.31 per share during the prior year period. Excluding stock-based compensation expense and amortization of purchase intangible assets non-GAAP net loss for the fourth quarter was $4.2 million or $0.18 per share, compared to the net loss of $2.9 million or $0.26 per share during the prior year quarter.
Continuing the full year financial results. Revenue for Violet was $64,000 in the fiscal year ended January 31, 2016, up from $1,000 of prior year reflecting the first full year of online and retail sales. Total operating expenses on a GAAP basis were $15 million for the year, compared to $8.6 million the prior year primarily as a result of increased expenditures for the company’s acne drug pre-clinical preparations marketing and commercialization efforts for Violet and increased corporate G&A costs of being NYSE market public company.
GAAP net loss for the year was $16 million or $0.89 per share compared to a GAAP net loss of $9 million or $0.85 per share during the prior year. Excluding stock-based compensation expense, a one-time expense related to the modification of warrant and amortization of purchase intangible assets. Non-GAAP net loss for the year was $14.3 million or $0.80 per share compared to a net loss of $7.7 million or $0.73 per share during the prior year.
Our weighted average shares outstanding the $23.4 million shares for the fourth quarter following the most recent capital financing and the full quarter effect of the Franklin investment, weighted average shares outstanding is expected to be approximately 26 million shares for the first quarter ended April 30th. Cash and cash equipment as of January 31, 2016 were $4 million. Since the close of the fourth quarter, the company completed public offering of its common stock of approximately $4.3 million in gross proceeds.
At this point, I’d like to turn the call back to Jim for closing comments.
Thank you, Greg. As we wrap up our discussion of fiscal 2016. I would like to express my appreciation for the confidence our investors replaced in BioPharmX over the past year and thanks our employees for their commitment to our success. It’s been less than a year since we uplisting from the OTC market to the NYSE market. Since that time Franklin advisors has taken a 16% stake in BioPharmX and we continue to attract new investments in our recent offering.
Our Violet product is landed on retail shows of more than 7,500 stores in the U.S. and we have commenced phase 2clinical trials for a novel formulation of the proven drug minocycline to fill unmet need in the $3.3 million acne market here in the U.S. We remain committed to building on this foundation and achieving our goal of becoming a leading specialty dermatology company.
With that like I’d like to now turn it over to the operator for questions. Operator?
Thank you. We will now begin the question-and-answer session. [Operator Instructions]. And our first question will come from Anthony Vendetti of Maxim Group.
Thanks. Just wanted to go over a little bit more on the Phase 2a. I know that it’s technically -- for BPX-01, I know it’s technically for safety. But are you going to be looking at more than just safety, you’ll be looking at efficacy and what do you expect to see after this trial based on your initial -- I know you’ve gone through a lots formulations but based on your initial expectations what kind of results are you looking at before you go to Phase 2b?
Yes, great question as you mentioned the first which clearly it's focused on let's safety but we’re also really focused on looking at the tolerability of the product at this stage as well. So I had mentioned that we are looking at things like itching, redness, scaling, other tolerability aspects and then that differential. So this is the real two key aspects of Phase 2a and then really looking at that two different inactive vehicle control against BPX-01 alright sitting back understanding and allowing us to move into that phase 2b.
Okay. And can you give us any other update on I know that you mentioned 7,500 retail locations through Violet, but just is there any other major retail outlets that you are expecting throughout 2016 to be potential violet sellers or stock Violet.
Now one thing I can mention that we didn’t cover in earlier discussion and that is we did fully deploy, I think we mentioned the last quarter, we did fully deploy Harris Teeter, our first grocery chain and that is now in all shelf and they have since placed there first re-order actually in February, so that was a great time for us there. The other thing I can mention as we just here in the last month also added distribution online with Amazon it's through an Amazon store and I'm happy to report that we did a very, as a small pilot there and our products that we put out sold out in the first week, so for us those are all pilots that were evaluating to see how market adoption continues and from all these different insights from the different channels we’re going to make larger decision as far as which distribution segment makes the more sense for the further expansion.
Okay great and then we are working on other biologics and stuff as there are any color you can give on what the R&D pipeline looks like or is it too early at this point?
Unfortunately it's a little too early at this point I think Jim indicated that we are looking at the aesthetics space as most everyone on this call probably realizes that is a very large market and we are talking 12 billion plus market opportunity there but little early as far as we’re specifically there, but will be back to you saying on that.
Yes, it's Jim. What we also alluded and as we have done in the past that our topical delivery system for our BPX-01 it's a solvent system, it's uniquely formulated with the lot of provisional patents around it and from that we have a pipeline, it's a natural to look at other indications and also even combination therapies and we've alluded to that. There is R&D development going on in those area as well to really kind of take advantage of what we develop there.
So it's a combination right now as of the topical delivery system on the antibiotic side and working with biologics on the dermatology side and looking at the aesthetics market for they are very both big opportunities for the company, where there is a lot of big unmet need.
Agreed, okay great thanks so much.
And the next question will come from Ramakanth Swayampakula of H.C. Wainwright.
You ended up, ended a great year and congratulations on that. I have a few questions just to start up on the BPX-01, so you are pretty much expecting to get the Phase 2a completed by middle of this year. So is there a hurdle at all to get the Phase 2a done before you start the Phase 2b or this is pretty much you are just waiting to complete the first study before you start Phase 2b, is there anything that you need to learn before you start the next study, which in supposed to be in the summer.
No we are not waiting on anything from 2a to drive 2b, so this is just a logical progression of the study flow. So it's very rapid though as we mentioned, so as since we've already accomplish full enrollment and the phase is already underway, it's a four week study, so it's really just a progression.
And we can’t emphasize enough that the expense of preclinical development that we did prior to submitting our IND and moving into these Phase 2 trials. Expense of work in the lab with animals, studies and all the various testing that’s required to really understand where we want to and how we want to approach the clinical trials, we did extensive work upfront and I think that’s really going to payoff for us as a company.
Okay, thanks for that. Jim you were alluding to potential additional indications for BPX-01. Is this too early to start talking for additional indications or are you willing to disclose some of your thoughts?
I think we will be willing to disclose, what we’re doing here probably over the next two quarters. Our goal was really to focus on the first indication acne and get that IND submitted, get into those trials and as you can imagine our R&D is busy working now on the pipeline. And leveraging what we already have, we’re only going to be just a quarter or two away for making some announcements on some of the pipeline there. So near-term.
Okay. So on the just give same ID in our BPX-03. At what point will we be able to learn more about your plans on the Phase 3 development program?
Sure. So the intent here is I cannot mentioned, we started the Phase 4 IRB study right now in Canada and the U.S. So our goal is to work on that study and receive our data from the results of that and that will be two things, one it will insight what a Phase 3 will look like, it will give us some very specific criteria on formulation of that and what we would go back to FDA for special protocol meeting on. So we see that as a sequential event.
Okay. So you’re looking for SBA, okay. On BPX-02 the biological, how much work you need to do before you disclose what that is and what the clinical development program will look flat, for that drug?
It’s a little tough to answer. Since we’re not really disclosing the focus of that at this point. But having stated that is a biologics product, it would obviously go through that half way from a regulatory standpoint. And then we would have to come back to you guys and share a little bit more specifically what that schedule will look like hinting [ph] what the product focus for different indication purposes.
Yes. And we’ve been working on this product area now for a couple of years. Similar to our novel delivery system on the topical antibiotic, we’re developing something that’s very novel here as well and really trying to focus on what is patentable and can people be protected. And that’s why we continued to be fairly silent and what we’re working on here, because we really want to make sure that we’ve got all of our basis covered before we show our hand in this area.
And maybe just elaborate a little bit on Jim just mentioned. We will continue to follow suit though with the novel delivery system approach. So what you see from coming in delivery system with potential further application in our pipeline for current antibiotic active. As we look to biologic, you can anticipate something very similar and approach.
Okay. And then last couple of questions on Violet. So you mentioned that you are looking for some partnership or distributorship. So what is this collaborative or the idea collaborative that you want there is in a partnership or distributorship and what is that you’re looking for?
We’ve mentioned that our strategic goals to becoming leading dermatology specialty pharmaceutical company. And we’ve got a novel talk to delivery system working now and the area of targeting the air of aesthetics. We really saw women’s health as a good opportunity as well for us. And we’ve had a -- we develop a pretty nice assets here with Violet since we launched last year and incurred those column commercialization launch costs.
We build up now a pretty good size of retail distribution, we’ve built us some very good awareness. I can tell you that well the magnitude of the adoption numbers are not large, the interest is large. The women, we’re seeing a lot of repeat customers coming back, we’re seeing great testimonials. Interesting enough is we don’t get pushed back when the product doesn’t work or anything like that, it’s really more of getting the product out, they’re building the awareness, because for women this condition, there is not been a solution out there and this is the first of its kind and it’s a big market opportunity. But to make women aware of the product. We’ve tried around and we’ve had some pretty good success for us to pretty good start of establishing channels through in major leading retailers.
That being said there are some big women's health companies that are out there here in the U.S. and Europe and other country and some of which have even tried an attempted offerings in this area for FBC and have failed. So there is an opportunity that exist for our company like BioPharmX to partner with a few of these bigger companies to exploit some of their already existing channels, existing channels that could already include numerous products and multiple SKUs right versus as a product like ourselves which is more of a development company, trial focused, to get products to commercialization and with us a rich pipeline of dermatology why not consider partnering with the women's health company.
And to be honest if you talk to these bigger women's health companies they’ve been starved for pipeline, they’ve been starved for new product opportunities when you go into retail outlets and you look at the feminine care isle, you just haven’t seen a lot of new products in the last five to 10 years. So what we have to is very normal and unique the challenge of courses building the awareness and it takes time and we now we are seeing that with other products into the markets and so we feel that we've taken a good first shot at really getting this product launched getting it out there women love it, but we need to get in front of more women and we our market expenses to date reflect a lot of this launch cost from the last year, which we can now shift more into a maintenance mode and really leveraging the retail channel that we started to build so we don’t have those initial launch cost are behind us, even the manufacturing scale up we went to our facilities at the GMT base, this is all Pharma grade.
So we've taken a very conservative approach to rev-rec, only on a sell through basis in combination with even our inventories we do not hold inventories with any real value because we really want to see where the products trending. But I would say you the interest from some of the big women's health companies right now to partner with us is very intriguing and we are going to look at, at what we can do there to really broaden the distribution on Violet.
Thanks for that detailed answer. One last question, is this product still being sampled in certain geographies or we are not sampling anymore of this.
Yes it is so as part of this continued effort that Jim mentioned we are absolutely sampling direct to the healthcare provider offices. So we have an ongoing establish presence and over 500 locations now and those shows now we have over half of them in repeat fulfillments and we anticipate expanding that, so where our repeating to established offices and more expanding into new one.
Okay, great. Thank you very much and good luck for further coming quarter.
[Operator Instructions] Our next question would be a follow up from Anthony Vendetti of Maxim Group.
Greg. Just a quick question that the cost of goods sold for the quarter was that a onetime large number for the quarter or what's behind that?
Hi. Anthony. As Jim just mentioned we've been very conservative with how we think rev-rec on a softer basis and we've been our conservative with these value into the inventory our balance sheet and so during the quarter we did take sort of a onetime hit to our cost to good sold related to inventory adjustment and when we think about Violet as volumes increased we still expect the gross margin on Violet to be in the 60% plus range on that product so really more of a onetime adjustment
Yes think at this way Anthony that the shelf write from Violet is actually very long but initially we specs were in the 2 to 2.5 year range and that's even becoming bigger now, it’s probably going to approach about five years because it's very stable, the way this products was developed and so it's not a reserve because this is not sellable inventory it's a reserve because we are really being very cautious and conservative, we really want to see how the adoption trends and we don’t want to carry it forward the new year.
Got it, okay great. Thank you.
And this concludes our question-and-answer session. I would like to turn the conference back over to Jim Pekarsky for any closing comments.
Yes well thanks for joining us today and we look forward to providing another update in June. On our next earnings call for the first quarter ended April 30, 2016. Thank you.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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