Q3 2021 Mediwound Ltd Earnings Call
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Good day and welcome to the meta wound third quarter 2021 earnings Conference call. Today's conference is being recorded at this time I would like to turn the call over to Mani coffee of lifestyle advisors. Please go ahead.
Thank you Sarah and good morning, everyone earlier today.
Issued a press release announcing financial results for the third quarter 2021.
May access that release on the company's website under the investors tab.
With us today is Sharon Malka, Chief Executive Officer of met a woman and Boaz Gur lavie.
<unk> financial officer.
Following managements prepared remarks, we will open the call for Q&A.
Before we begin I would like to remind everyone that statements made during this call, including the Q&A session relating to medicines, they expect a teacher performance.
That's your business prospects or future events or plans are forward looking statements as defined under the private Securities Litigation Reform Act of 1995.
Although the company believes that expectations reflected in such forward looking statements are based upon reasonable assumptions.
Outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of medical.
The company assumes no obligation to update or supplement any forward looking statements, whether as a result of new information future events or otherwise participants are directed to cautionary notes set forth in today's press release as well as the risk factors set forth in medicines annual report filed with the SEC.
For factors that could cause actual results to differ materially from those anticipated in the forward looking statements.
The conference call is property is medical and any recording or rebroadcast is expressly prohibited without the written consent of medicine.
Now I'd like to turn the call over to Sharon Malka, Chief Executive Officer of shoe of meta was Sharon.
Thank you Mike.
Good morning to our listeners and good afternoon, Nathan as he needs Brian well.
Welcome to our third quarter 2021 conference call to discuss our financial results and provide you with our business highlights.
We have been very active this quarter and the subsequent weeks, making progress across our portfolio.
And hearing some very important and finally, increasing event in both of our lead programs with.
We gained regulatory clarity on the basketball award for Resubmission of the Nexobrid BLA following a productive type a meeting with the FDA and we continue to advance significantly the SK <unk> clinical development program towards data readout.
Let me begin first with a review of our <unk> program, followed by an update on our Nexobrid pull down.
Yeah.
Starting with desk, we made significant progress in the clinical development plan.
S. Keryx team has been very busy as we near completion of enrollment in our ongoing phase II adaptive design trial for the treatment of venous leg ulcer.
We anticipate completing enrollment before the end of D. C. And currently expect to report topline data from this study in the first quarter of 2022 earlier than originally planned.
As a reminder, this study is a multicenter prospective randomized placebo controlled study in 120 patients designed to assess safety and efficacy of <unk> in debridement of failure.
The primary endpoint in this trial is incidence of complete debridement compared with gel vehicle.
In conjunction with our phase II adaptive design trial.
Our team has also been focused on executing on our phase II Pharmacology study and we are on track for generating initial data by the end of this deal.
As a reminder, the pharmacology trial is an open label single arm study in up to 15 patients designed to assess the pharmacological effect of <unk> in both the basic food ourself and venous leg ulcers.
We aim to gain a better understanding of what is happening in the wound bed bath viewing and after debridement with <unk> correct and to assess number of clinical effect impacting wound healing.
Lastly on that is correct. We are very pleased to see our in vivo head to head comparator study of aesthetics published in the journal of wound care.
Well it in theory with Paypal.
The study showed S correct to be more effective than the commercially available collagenase product in removing the eschar in this both in ESCO model.
We are very enthusiastic with this program and believe ex cat ex has the potential to become a game changer in the chronic wounds. He provided market. We look forward to having data from both trials soon which we believe to add much value to our growing portfolio.
Moving to Nexobrid, we recently.
<unk> had a productive type a we the F D. A where there is agreement on the Festival award to address the questions and information requests by the F D. A.
Continue to partner with fairy tale and powder and we're currently targeting a BLA resubmission in mid 2022.
We anticipate a six month review period with a potential approval by year end 2022.
In tandem we continue to enroll new patients at leading U S burn centers, the neck expanded access program, which will run through approval.
We remain enthusiastic about the prospects and long term potential for Nexobrid and look forward to potentially bringing this innovative product to the U S market.
As expeditiously as possible.
We are thrilled to announce earlier this quarter the positive topline results from our phase three study of Nexobrid in children with severe thermal burns.
Which met all its primary endpoints with a high degree of statistical significance reinforcing the song of clinical safety and efficacy profile of the product.
Following doses that we are planning to submit the data for label expansion in Europe and other international markets. During 2022 and believe it with father in haste golf and global expansion of Nexobrid.
On the commercial front, we continued to gain commercial traction in Europe and globally.
By the best procurement for their emergency stockpile continuous to drive product revenue growth and we are expecting to recognize the remaining revenue related to the BARDA procurement by end of the first quarter of 2022.
In addition, we continue to execute on our global expansion strategy.
With sustained revenue growth.
We see more and more burn centers that aren't you up embracing nexobrid at the standard of care.
Globally, we recently received marketing approval in the Crane, Taiwan, and United Arab Emirates, and anticipate more to come and lucrative market.
Japan, India and ideal during 2022.
Lastly, we recently initiated a U S phase one two study of <unk> five product for the treatment of low risk fastest cell carcinoma, and the phase two investigator initiated trial in non melanoma skin cancer is running in parallel.
With that the form both expected in the first half of 2022.
Now I would like to turn the call over to Bob for a summary of our financials.
Thank you Shannon and good morning, everyone.
First I'd like to reiterate our continued product revenue growth from both the U S and ex U S markets.
Nexobrid continues to gain traction into new territory.
We're expecting to increase our outreach and revenues outside of the U S supporting our balance sheet with the growing profitability of Nexobrid.
Moving to our third quarter and first nine months of 2021 financial results.
Total revenues for the third quarter decreased 4% to $6 4 million.
<unk> to $6 6 million for this fourth quarter of 2025.
5% sequentially.
Total revenues this quarter included product revenues of $3 1 million and development services revenues provided to BARDA or three 3 million a slight reduction compared to just $3 5 million for the.
The same periods last year.
Product revenues this quarter were primarily driven by BARDA procurement of Nexobrid for emergency response, preparedness and increasing sales outside of the U S.
Total revenues year to date increased 21% to 18 3 million compared to $15 1 million in the same period of 2020.
Product revenues for the first nine months of 2021 9 million, an increase of 81% compared to the products' revenues of $5 million for the first nine months of 2020.
Revenue growth was primarily related to part of recruitment increasing sales in the Europe and expansion of Nexobrid into new territories.
Gross profit for the third quarter was $2 5 million with a gross margin of 39% compared to a gross profit of $2 8 million and gross margin of 42% for the third quarter of last year.
Gross margin for the first nine months increased from 35% in 2020% to 40% in 2021.
Research and development expenses for the third quarter were $2 9 million compared to $2 1 million for the third quarter last year.
<unk> was primarily due to clinical development program that's correct.
Selling general and administrative expenses for the third quarter were $2 4 million compared to $2 2 million in the third quarter of 2020.
Operating loss for the third quarter was $2 9 million compared to a loss of $1 5 million in the third quarter last year.
For the first nine months of 2021 operating loss was $7 7 million compared to a loss of $6 5 million in the first nine months of 2020, primarily due to increases in research and development expenses.
Net loss for the quarter was $3 3 million or <unk> 12 per share compared to a net loss of one 9 million or seven cents per share.
Third quarter of 2020.
For the first nine months of 2020.
Net loss was $9 4 million or 34 cents per share compared to an emphasis saving one 5 million or 27 cents per share for the fourth.
Part of the period.
Adjusted EBITDA for the quarter was a loss of $2 2 million compared to a loss of <unk> 8 million.
The third quarter last year.
For the first nine months of 2021, adjusted EBITA was a loss of $5 5 million compared to a loss of $4 7 million for the first nine months of 2020.
Moving to the balance sheet highlights as of September 32021.
Cash and short term investments were $13 9 million compared to $21 6 million as of December 31, 2020.
We remained on budget utilizing seven 7 million.
As the first nine months of 2021.
We reiterate our cashiers guidance for 2020, one to be in the range of nine to 11 million.
With revenues growth BARDA procurement and expected cash in summer fun being a proven and based on our current operating plan we believe.
Is that the existing cash and cash equivalent would it be sufficient to fund currently anticipated operating expenses through midyear of 2023.
With that I've concluded my financial overview.
I'll now turn the call back over to Sean Sean.
Thank you Budd.
As we approach the end of the U we remain optimistic about our program as we move towards important milestones in the coming quarters.
We look forward to keeping you update.
We continue to execute.
With that it is now my pleasure to open the call for your questions operator.
Thank you can I ask a question you will need to press Star then one of your telephone to withdraw your question. Please press the pound key.
Please standby, while we compile the Q&A roster.
Our first question comes from the line of Josh Jennings with Cowen and company. Your line is now open.
Hi, This is Brian here for Josh. Thank you for taking my questions.
To start on Nexobrid did the scope of the additional work change as part of your recent meeting with the FDA review team.
You would previously cited three areas to address and your intention to provide a safety update is that still the outstanding work to be done or has the required work changed in any way and I have a follow up on NASCAR extra format.
Sure good morning buying and thank you for the question. So the short answer is no and more.
Did I answer it that there are four things that we have communicated before one is day. Additionally, CMC gainful.
Requested next Tuesday inspection of the quiet by the F D a thorough facilities and Nissan and taught in Taiwan.
F D a.
For an observation on the DCP inspection and certain detect sites.
And finally, a routine safety update which we are preparing to include as part of the Resubmission.
So overall there are four elements that are all moving forward with the support and funding of BARDA and again, we had a productive meeting with the FDA and agreement on how we were going to respond to the questions and information requests. So with the work that is being done and completed Dan.
It will be assembled into the resubmission package and submit that at this point, our anticipation I said ease by mid year 2022, and we anticipate the six month review period with potential approval by year end 2020.
Okay. Thank you for that and on S. Correct do you have a sense of the size and timing of either a second study in V. L. You were Trialing D F U and if the upcoming phase two results in V. L. You are positive do you have clarity yet on whether these can stand as one of the two pit.
The old datasets, you'll need for FDA approval. Thank you again.
Sure. So I think it's a pretty mature at this point to provide something that dialogue spectation for the next stage first we need to complete the ongoing phase two study and of course the pharmacological.
Study the next step will be to discuss with the FDA. Once we have the results of the ongoing phase two data and the pharmacology phase two data we plan to have an end of phase two meeting with the FDA in the second half of 2022. Once we have that sits out there are complete.
A study report.
To discuss the pivotal stage, which include of course, the indications the sample size like choir study design et cetera.
Once we have this clarity once we have the data and then the meeting will be able to share much more information with you.
Okay makes sense. Thank you.
Our next question comes from the line of Ryan Zimmerman with B T. I G. Your line is now open.
Good afternoon, Sharon good afternoon, Bob Thank you for taking my questions.
Just to follow up on a couple of things one.
Within Mexico bread, what components as virus I will take the lead on versus maybe what you guys are taking the lead on for the Nexobrid Resubmission and then I have a follow up on Nexobrid as well.
Sure. So a dead they are bringing nexobrid into the U S market. He said John collaboration as you know.
Which vary say, let the commercial partner <unk>, the supporting organization and of course, many wounds with its extensive experience and expertise with nexobrid in the last 20 years.
And after the Resubmission itself, we have vast experience with the product keeping the 20th of Italy. There is they'll have a clinic got it.
<unk> and <unk>.
<unk> teams with a great deal of experience in great deal of success on that front. So we believe we are in a great position to leverage very sell track record, leading the regulatory front our years of experience with Nexobrid and part of that especially matter consultant supporting gas will bring.
Personal experience and we believe that this John collaboration.
Providing us with the confidence that we have the best team to achieve the BLA approval.
Okay.
And as far as usage in Europe goes Sharon what types of Burns are you seeing.
As more sites do start to use Nexobrid, maybe just talk a little bit about kind of how the utilization and usage is looking and whether we should view that as you know an example for how burn surgeons in the U S think about use of Nexobrid. Thank you.
Thank you for the question. So I think that's what you see now in the last let's say one in Africa and Europe is that all.
All leading burn centers that we are targeting and walking we'd basically Dan nexobrid at the standard of care and if at the beginning of this started with specific band it sometimes can be small bad it can be some specific areas like hands. Currently it's the standard of care in those leading burn centers.
Yeah.
Moving to the U S and our expectation we have to remember that we currently are running an expanded access program in the U S and reach about 20 to 25 band centered leading burn centers in the U S keep three things Ben.
Patients with Nexobrid.
Most without limitation up to 30%.
All areas, it's less restrictive protocol in the detect study.
So I believe that the fact, they generate more confidence more and more.
More hands on experience with Nexobrid will enable them to be more tolerant towards kind of band a tubule.
To be used once approved.
And hopefully it will be also reflected in the uptake of Nexobrid to the U S market.
Got it thank you.
Cool.
Our next question comes from the line of Kevin <unk> with Oppenheimer. Your line is now open.
Hey, guys. Thanks for taking my questions I guess.
As we prepare for the phase II.
Oh, you update for extracts.
How should we think about sort of the scope of it at least.
The initial topline disclosure should we.
To get you know relatively significant tolerability and safety data alongside of a wound healing or will you look to.
Potentially you know pulled some data for her future presentation or publication.
Thank you for the question Kevin So.
So I see a communicate you know we expect to report topline data from this study in the first quarter of 2022, which is one quarter earlier than originally planned.
And this will be if bearing of course to the primary endpoint and safety data from this study and it will be followed with additional <unk> and later on it will be followed with additional secondary endpoints and long term safety analyses, which will come through in the second quarter.
Great and then just a follow up on the Nexobrid BLA Resubmission Hum.
How should we think about you know.
The timeline to find here on the contact styles.
The facility inspections, I guess, particularly in Taiwan.
No question not at least currently I'm not sure many of us have a lot of visibility on.
What steps will even sort of.
Table that process so the how.
Yeah.
I'll detail can you you kind of provide some perspective on how that questions currently being handled.
Yeah. So as you know there are some.
Some travel restriction worldwide.
There, it's a little premature at this point to estimate what will happen once we submit that giving the dynamic of the pandemic and that's something we will discuss with the FDA apparently some mission, but we do know that those inspection outside the U S are now occurring.
So hopefully we will be in a position that foreign tourist submission would be a barrier to schedule an inspection in both facilities.
Thanks for taking my questions.
Yes.
Thank you.
As a reminder to ask a question do you need to press Star then one on your telephone.
Our next question comes from the line of play up a color what Braemar <unk> with H C. Wainwright. Your line is now open.
Thank you.
Good afternoon, Sean and Baas.
Couple of quick questions on Nexobrid.
Hum you were talking about the EAP program I'm, just trying to understand you know.
How many patients have kind of either undergone this program are enrolled into this and you.
How how who could utilize this data, especially when youre going into the submission.
Yeah. Thanks for the question. So the expanded access program as I said advanced through approval.
And include both pediatric and adult population, we continue to actively and all new patient into DC next protocol at leading U S burn centers across the U S with over one half the 20 burn victims already treated with Nexobrid to date and of course, we plan to generate data.
From this a protocol that is the goal of these protocol from the past.
<unk> people, if the FDA about that very thing in those cells. Both the cost effectiveness desktop usage data and safety that that that can be so kind.
Support discussion with F D. A of course the safety.
Analysis of the first 100 patients or something like that will be captured as part of the a safety update that we'll have will be part of the re submission, but also out there.
Hopefully that that that we will get from this study will support the discussion with the FDA.
Perfect. Thank you so talking about the pediatric study.
You said that you would have.
Data from that.
Hum.
Into 'twenty, two so what sort of you know what.
And would you published that data is it going to be a publication or would you be pleasant. He got some conference. So we see additional details from that analysis yet.
Yeah. So.
I believe that the data will be presented in the next IPA, which is anywhere around equity next year 2022.
Not less important the just published did that because we shared with that Diana and yeah. We are planning to use this data level actually sat down and submit this data for label expansion in Europe, and other international markets and if accepted and we will be able to submit it during <unk>.
<unk> 22 for label expansion in these territories and we believe it will.
Further enhance growth and global expansion of Nexobrid bauxite.
Okay. So last question from me is.
You were talking about a couple of expense expansion geographies like you are you thinking of Spain.
Okay.
It is that you talked about do you have.
Distribution partners already in these geographies are you're establishing them now and also what sort of market.
Are these like what's the market size is geography for you.
Yeah, So generally speaking going to the international market that can show you that we continue to execute on our global expensive thought that you would sustain revenue growth as a reminder, our focus is Latin America see countries Asia Pacific and EMEA in the Middle East.
We recently received marketing approval in Ukraine in Taiwan, and United Emirates, and we anticipate more to come in some lucrative market and when would you think to lucrative markets, we refer specifically to Japan, where the distributor already filed for an approval.
Looking for India, well distributed in the last mile of getting it approved and launch it and other territories during 2022.
Thank you. Thank you Rochelle and my boss.
Okay.
Thank you.
There are no further questions I will now turn the call back to Sharon Malka C O of marijuana for closing remarks.
Thank you Sarah and thank you everyone for joining US today, we look forward to updating you again on our next call. Thank you an advocate that.
Okay.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.
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