Nissim Mashiach – President and Chief Executive Officer Mark Page – Chief Medical Officer Mike Molyneaux – Chief Medical Officer.
Matthew Keeler – Credit Suisse Steve Lichtman – Oppenheimer and Company Ian Somaiya – Nomura Securities Raj Denhoy – Jefferies.
Welcome to Macrocure's First Quarter 2015 Financial Results Conference Call. Before we begin, I would like to remind you that forward-looking statements will be made on this call. Forward-looking statements provide the company’s current expectations or forecast on future events.
Forward-looking statements include statements about the company’s expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts.
Forward-looking statement are subject to known and unknown risks and uncertainties and are based on potentially on inaccurate assumptions that could cause results to differ materially from those expected or implied by forward-looking statements.
The company’s actual results could differ materially from those anticipated in the forward-looking statements for many reasons. And I encourage you to review the document filed and furnished by company with or to the Securities and Exchange Commission including without limitation.
The company's annual report on Form 20F then ongoing report on Form 6-K, which identifies specific risk factors that cause actual results or events to differ materially from those described in the forward-looking statements.
Unless required by law, the company undertakes no obligation to publicly update or revise any forward-looking statements to reflect current circumstances or events that occur after the date of this call. At this time, I would like to turn the conference call over to Mr. Nissim Mashiach, Macrocure’s President and Chief Executive Officer.
Sir, please go ahead..
and Francesca DeMartino, our Vice President of Investor Relations. I want to start by welcoming Lewis Gryziewicz to Macrocure. We recently announced Lewis appointment as a VP Regulatory Affairs.
As we need the completion of our clinical trials, our goal is to quickly and efficiently shift our focus to Biological License Application or BLA submission to the FDA for CureXcell. When we consider the focus and attention required for success, we felt it was time to add some one with Lewis expertise.
Lewis has nearly 30 years of experience in the fields, for the last 16 years he has held senior level position at Allergan, Johnson & Johnson and Bristol-Myers. Most notably he has deep knowledge of biologics and has vast experience interfacing with regularity agencies around the world including the U.S., Europe and Japan.
Lewis will be instrumental in completing and submitting our BLA filing at the U.S. and supporting our ongoing dialogue with the FDA. Additionally, he will lead the regulatory strategy for CureXcell with regulatory agencies outside of the U.S. and with any pipeline indications we pursue in the future.
Turning to our business outlook [ph], on today’s call I will review our most recent corporate achievements, provide an update on the progress of our clinical trials and lastly outline the milestones calendar for the remainder of the year.
Mark will provide an overview of our financial results for the first quarter 2015 and then we will open the call for questions. I will start with an update on the clinical development of our lead product candidate CureXcell. As a reminder, we are conducting two pivotal double blind randomized Phase III clinical trials.
These trials in Diabetic Foot Ulcer’s or DFU and Venous Leg Ulcers or VLU will support our BLA filing for broad label indications for the treatment of chronic wounds below the knee. This quarter, the most important update concerned our VLU trial.
We commenced patient enrollment in May of last year and by last October we had 25 clinical sites actively enrolling patients. Last quarter we announced that due to a strong recruitment rates, we were able to accelerate our timelines. Today, we announced that we have completed patient recruitment for the VLU in the last few days.
Our next important milestone for the VLU is in August of this year when we anticipate announcing the results from the futility analysis. We will issue a press release, announcing these results including the recommendation of the Data Safety Monitoring Board or DSMB.
As we mentioned on our last call giving the significant key of advanced [ph] timelines, we have executed, this futility results will replace the interim analysis we had initially planned to conduct. Lastly for now, we are maintaining our guidance that we will report Phase III VLU results in the first half of 2016.
However with the overall acceleration of this clinical trial, we are assessing more precise timing for this result and we’ll be able to provide you an update on our second quarter earnings call in early August.
Turning to the DFU trial, we are pleased to reconfirm the timeline, we discussed over the last quarterly call that we are on tract to report the data in October of this year.
Currently, we are focused on completing the treatment period and allowable treatment windows conducting the follow up for safety and durability and moving through database lock in early September.
Finally, two additional corporate updates to note, we have presented two clinical abstracts at the Symposium for Advanced Wound Care or SAWC and one additional abstract in the Annual Meeting of The Association for Research in Vision & Ophthalmology or ARVO.
The SAWC abstract highlighted the findings from our mechanism of action study including CureXcell ability to promote blood vessel formation or angiogenesis, maturation, cells proliferation, collagen density and organization and granulation, tissue formation. The ARVO abstract, discussed the in-vitro results in human corneal epithelial cells.
In-vitro CureXcell was shown to impact both corneal cells proliferation and migration when compared to active control. In summary, we are executing our business strategy and advancing CureXcell that was commercialization.
We continue to believe that CureXcell has the potential to transform the wound care space and how chronic and how to heal wounds are treated. We owe our success to our excellent team at Macrocure. Our progress today indicates their collaborative commitment, focus and passion.
Needless to say, we are all excited for the second half of this year and are highly confident in the prospect of our continued success. I’ll now turn it over to Mark to review our financial results..
Thank you, Nissim and hello everyone. Today, I’ll review our financial results for the first quarter ended March 31, 2015. Research and development expenses for the first quarter of 2015 were $5.3 million compared to $2.7 million for the first quarter of 2014.
This increase was primarily due to total clinical trial expenses for our DFU and VLU Phase III clinical studies.
General and administrative expenses for the first quarter of 2015 were $1.6 million compared to $0.7 million for the first quarter of 2014, this increase was primarily due to elevated payroll, stock-based compensation and HR recruiting expenses as well as increased professional expenses and customary costs associated with being a publically traded company.
For the first quarter of 2015, we reported a net loss of $6.9 million or a loss per share of $0.38, compared to a net loss of $3.4 million or loss per share of $0.46 in the same quarter of 2014. I will now turn to a few other items.
Regarding balance sheet as of March 31, 2015, our cash and cash equivalents including short-term investments were $41.7 million. As of March 31, we had approximately $16.7 million basic shares outstanding, this figure excludes $1.3 million ordinary shares issuable upon exercise of warrants at an average exercise price 0.01 [Indiscernible] per share.
We reiterate that our expected operating expense cash burn for 2015 will be in the range of $21 million to $25 million, this figure excludes potential CapEx on commercial manufacturing capabilities we expect to develop this year. With that summary, I will turn the call back to Nissim..
Thank you, Mark and before we move to the Q&A, I want to review the timelines for our clinical milestones. For the DFU, we anticipate reporting full Phase III clinical trial results in October. For the VLU we anticipate reporting futility analysis results in August and full Phase III clinical trial results in the first half of 2016.
We’re on track to submit our BLA to the FDA in the second half of 2016. Operator can you please open the call to questions..
[Operator Instructions]. Our first question comes from the line of Bruce Nudell of Credit Suisse. Your line is open. Please go ahead..
Hi guys, this is Matt on for Bruce, can you hear me okay?.
Yes..
Okay, I have two questions, first, as we think about the VLU futility analysis, can you help us sort of think about that there, it is happy the futility now just indicate a high likely that a trials expressed or just sort of a chance for being successful or how should we think about that?.
So, Matt, thank you.
The way to look on the futility analysis and is what we are going to report in August this year is basically probability for success and there will be three scales that we are going to report based on the DSMB recommendation 0 to 30 where the DSMB will say stop the study because there is no separation - goods separation between the group.
0 to 30, 30 to 45 and 45 and above this is where we anticipate being as an outcome for the futility which is weight [ph] separation continue to move on. And this is how we are going to present the data.
Mike, do you want to add anything to that?.
No, Nissim, that’s exactly, what we’re looking at for the results..
Okay, perfect.
And then my follow-up is the Symposium for Advanced Wound Care, can you sort of share with us the feedback compositions to the mechanism of action data and just picture itself in general?.
Yeah, Mike, I will let you to answer this question..
Yeah, in general math, the feedback was extremely positive, the postures got a great deal of attention and we also had in our oral presentation in abstracts, which attracted above 50 folks on the last day of the study, on the last day of the conference.
So in general, what they saw was something very different, as we’ve said in the past and now we’re just seeing [Indiscernible] action of studies without much clarity and detail and also little robustness of the data. So overall, people are very encouraged and very excited and it was a great conference for us and that got us a lot of exposure..
All right, great. Thanks for taking my questions..
Thank you..
[Operator Instructions] Our next question comes from the line of Steve Lichtman of Oppenheimer and Company. Your line is open. Please go ahead..
Thank you. Good morning, guys..
Good morning..
Just a quick question about the filing process with FDA, do you need to wait for the VLU study to submit DFU or can you do some sort of a rolling in process to perhaps speed up the review process?.
Good morning, Steve. Based on our discussion - previous discussion with the FDA, we need the two complete study in order file the BLA. So, yes we need to wait for the result of the VLU. We need to have the results of the DFU as well and the two study together with compile the BLA, we cannot just file one study and then the second study..
Got it, okay, great.
And then, Mark alluded to manufacturing, when will you grow that commence in terms of starting to build that out and can you remind us how long do you think that that will take to get up and running on the manufacturing side?.
Sure. So before I will give you some information about the timing and how it’s going to - when are going to start.
I would like to draw your attention that as you may know, we announced that we recruited a Senior VP of Operation, Ramesh, who has experienced in building manufacturing facility including the commercialization and getting the FDA approval for those facilities.
And at the moment, we are looking on the right location on the East Coast, probably somewhere between New York and Pennsylvania, Philadelphia area. And I think that over the next few months we will be able to give you some more concrete information about the timelines and final location.
We believe that the overall establishment of this facility would not be so long, because of the manufacturing process, which is a very straightforward manufacturing process and we believe that we’ll going to meet the overall timelines for the BLA, which is the second half of 2016..
Okay. Great. Thanks guys. That’s all I have..
Thank you..
Thank you. [Operator Instruction] And we do have a question from the line of Ian Somaiya of Nomura Securities. Your line is open. Please go ahead..
Thanks. Just wanted to follow-up on the futility analysis. Can you just elaborate a little bit more on the implications of the two other sort of outcomes, I think you mentioned I guess, 30 to 45 and the 45 and above. What are the implications you got? And is there a scenario where the DSMB could recommend the clouding [ph] stuff for success.
What need to have in for that success [ph]?.
Maybe giving you some more precise information about the three scales that the DSMB should give. And then Mike, you can jump in and as read the other part of the question. But I would say the first part which is zero to 30 it’s when the DSMB do not see a separation between the two groups the treatment arm and the control arm.
And they will drive the company to start the study. Zero to 30, they see some separation, but it’s up to the company to make the decision. And 45 and above is basically where we are expecting to be where they see a good separation study is one track for successful completion. As I said this were we anticipate VLU with the DSMB recommendation..
Right and just like 30 to 45….
Sorry, yes. 30 to 45 is the midpoint. Yes..
And is there a scenario where you’re so far about 45 that we should start the trial now..
No, I don’t think that again based on our discussion with the FDA.
There is no list of futility, especially when we announce today that we completed the recruitment and so there is no, we need to complete the full treatment periods of the safety, the follow-up, the durability and so, I don’t think that there will be any early stop for a - because of high futility..
Okay.
The other question I had was just around the early potential discussions you’ve had - doing preliminary discussions you might have had with payers and just kind of the feedback you’re getting from them?.
So, what I can say at this point, that we didn’t stop the discussion with payers. I think those discussion will be more substantial, once we have the clinical data from the DFU.
And at the moment, we are and we have a very, I’d say qualified reimbursement consultant that helping us to navigate the best reimbursement outcome both from a pricing point of view and a including [ph] point of view.
But as you know that should be done when you have good clinical data and this is where we are expecting to engage the discussion with payers and CMS and after October once we have the DFU results.
Mark and Mike, do you want to add anything on that?.
Well, I’d like to add, we’re biologic drug and we are going to be pursuing drug type reimbursements and I know there’s a lot of folks in the wound care sector around - med devices, skin substitutes, high and low bundles and even under that scenario, I think you guys know our model, our gross margins are very attractive even the most I think for [Indiscernible] enterprising, I think what Nissim is talking about is - our strategy to which were reflecting now, but talk with consultants and be ready with data in hands really have a very cogent, coherent dialogue with CMS about what our perspective reimbursement will be, especially when we have the data in hand..
Okay. Thank you, very much, thanks for taking my questions..
Thank you, Ian..
Thank you. Our next question comes from the line of Raj Denhoy of Jefferies. Your line is open. Please go ahead..
Hi, good morning..
Good morning, Raj..
I wondered, if I could add just - start from the last one of question, I think what - I’m sure as how you think this is going to be reimbursed at this point.
Do you think it’s going to be covered under the bundle payment for wound care products or will it be reimbursed as a biologic, as an injectable biologic, is there many changing in your thinking around that?.
Our thinking is that this is going to be reimbursed as a drug as a biologicals because we have a different mechanism of action because we have a very differentiated regulatory pathway in a clinical studies BLA pathway that has not been done in this space and that has been confirmed also by our consultants who highly believe that this would not be a product with good bridge [ph] subjected to the bundle.
And however I think that because of the gross margin that we have very high gross margin 80% and above, we believe that we’ll be successful in both way if it would be still under the bundle, I think we can still make the case, but I believe that we have all the elements will assume that this would be a separate reimbursed product as a biological..
And in terms of when you’ll get clarity on that, I mean essentially the product will ask you to prove it under the market and then those discussions will begin, there is no way to get anything before then?.
No, I think we will get some seasoning for that and as I said to Ian before, I think that our strategy would be to approach CMS and start to engage a key opinion leaders within CMS and payers, once we have the data from the DFU.
So probably in fourth quarter we’ll start some initial discussion and we’ll provide you of course some input based on those discussions. I mean this is a new products, it’s a new approach, I think that it would be in a way an eye opener for the CMS to appreciate the value of this product with its all this and type of attributes.
So we are going to be very proactive and that way just for the FDA approval and then engage, we’re going to do that immediately after the - via few readout..
And then just two clarification questions, I think Nissim in the first time you said that the - that there wouldn’t be interim look at the value, but it’s the futility announces over the summer, but I’m curious if you could remind us why that is, why you elected not to take that interim look and just a futility announces at this point?.
First of all, I think, we already discussed in our last quarterly call and the reason for that was really because of the recruitment rates.
We saw that the VLU is moving so fast and as a result, I mean let’s may be step back and see what we did, I mean, we recruited over 250 patients within less than 12 months, I think it’s a record within the industry of a wound care.
I’m not worried to any other company, in this space that this is double blind control with 25 clinical sites in United States and has been able to complete the recruitment with less than 12 months.
And so with that when we saw this high recruitment rate, we say why to do a futility interim analysis and pay the alpha penalty, add more patients and prolong the study, I mean, we are interested to see the results of the study and I’m sure all of investors would like to see it as soon as possible.
So there was no reason to delay that for interim analysis..
Fine, [Indiscernible] and the other component of that Raj two is that there is no early stocking for the VLU, so there really would have been no benefit other than potentially and early look where as we’re not going to stop early because the regulatory pathway is already so accelerated with two studies, two indications where it normally need three to four studies.
So for that reason we would continue to enroll the entire amount and subjects as well apart from what Nissim said that there also would be no really stopping..
That’s helpful. Thank you..
Sorry, Raj, and the practical result from last quarter was advancing the timeline by over half year and I think what we’ll obviously update the group about will be sort of some precision around from second half of 2015 to first half of 2016 where we’re going to actually land in the first half of 2016 with the final VLU results. [Multiple Speakers].
Okay. And that’s helpful. Thank you..
Thank you. And that does conclude our question-and-answer session as well as our conference for today. Ladies and gentlemen thank you for attendance, you may all disconnect. Have a great rest of your day. Moderators please standby..