Q2 2021 Mediwound Ltd Earnings Call
[music].
Good day, and thank you for standing by welcome to the key tee them anyway in 2021conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session you will need to press star 1 on your <unk>.
Telephone please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker today, Jeremy Feffer. Please go ahead.
Thank you Don and good morning, everyone earlier today <unk> issued a press release announcing financial results from the second quarter of 2021, you may access that release on the Companys website under the investors tab.
With us today are Sharon Malka, Chief Executive Officer of Malibu, and Boaz Gur Lavie, Chief Financial Officer.
Management's 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 <unk> expected future performance future business prospects or future events or plans are forward looking statements as defined under the private Securities Litigation Reform Act of 1095 on the company believes that the expectations reflected in such forward looking statements are based upon reasonable.
Assumptions actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors beyond the control of megawatt 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 from <unk> 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 the property of meta wound and any recording or rebroadcast is expressly prohibited without the written consent of network now I would like to turn the call over to Sharon Malka Chief Executive Officer.
On.
Thank you Jeremy.
Good morning to all of our USB Ethernet and good afternoon listener and Israel.
Come to our second quarter 2021 conference call to discuss our financial results and business highlights.
The second quarter of 2021, and the subsequent weeks have been eventful from clinical and commercial standpoint, we had a positive interim assessment for <unk> phase <unk> phase 2 study M.
F D. A feedback on Nexobrid, BLA and door Busters out of Nexobrid phase III pediatric study.
Commercially we continue to generate product revenue growth compared with the flywheel, we didn't buy the procurement of nexobrid by buyback and revenues continued growth out of U S.
On the clinical front.
We are pleased with the progress we gained across each of our ongoing clinical programs and are encouraged by the positive clinical data for both <unk> and Nexobrid.
Let me begin first with a few of our <unk> clinical development program.
He most recently and now the best possible outcome of the interim assessment for E. U S phase II adaptive design study.
Recall that this study aims to assess the safety and efficacy of <unk> correct for the day, great men offerings like ourselves has.
Compared to gel vehicle and nonsurgical standard of care.
On the interim assessment serve to debt the mine, where the sample size adjustment is required to maintain conditional power for this study.
The interim assessment had 3 potential outcomes.
Continuation of the trial at its current sample size.
An increase in the sample size to power the trial on.
Is that an end of the file due to futility.
They Ain't day assessment conducted after about 80 patients approximately 2 third of the original enrollment target of 120 patients completed the debridement treatment.
Based on the independent data monitoring committee's recommendation.
The interim assessment is the 2 positive takeaways.
First.
No enrollment sample size changes are necessary to maintain the pre specified statistical power of 80% on great deal for the studies primary endpoint of incidence of complete debridement compared to the gel vehicle.
This positive outcome, meaning that the studies appropriately sized at the planned enrollment of 120 patients and can continue without the need to add more patients.
As a reminder, we.
We had previously reduced the enrollment target from 175 patients to 120 patients. So we are happy with the independent data monitoring committee's recommendation confirming that change.
Second no safety concerns were identified in the study population, which is another positive people with us.
These successful interim assessment suggests that S. Correct is a safe and tolerable and provides positive thinking on that increase our confidence that S. Capex may prove to be an effective non surgical therapy for the bride meant of corn on corn.
We anticipate completing full enrollment in this study by end of 2021 with data readout anticipated in the first half of 'twenty 2.
Also on our ethics program, we have enrolled our first patient.
In our phase II Pharmacology study.
And anticipate data from that study later this year.
As a reminder, this is a phase 2 open label single arm study designed to evaluate the clinical performance safety and pharmacology effect of aesthetics in the deployment of lower like ourself, I E venous leg ulcers and diabetic foot ulcers in up to 15 patients.
The data generated to date for S. Correct have been very encouraging.
We published a peer reviewed paper summarizing there is that of a successful phase 2 assessor blinded study of our fifth generation <unk> correct.
<unk> achieved its efficacy and safety endpoints.
That's correct.
Well, it's well tolerated and has demonstrated safety and efficacy in the debridement of chronic and hard to outdoor old ones within the few daily applications.
Earlier this year, we completed successfully at compare though in vivo study designed to evaluate the debridement efficacy of S. Correct and the commercial collagenase enzymatic debridement agent in a pulse on how to will more than.
The study.
Concluded that aesthetic treatment was clinically superior to the commercially available collagenase agent in removing eschar in this model.
The data from this trial together with a positive interim assessment gave us confidence in both of our current ongoing phase II trials of second generation S guidance, and we look forward to data from both of these drugs.
With a clear unmet medical need for a nonsurgical rapid and effective debridement agent in the outpatient setting S guidance has the potential to improve on the current standard of care and have a meaningful impact on corn and corn from management.
Turning to Nexobrid.
On the commercial front BARDA procurement for emergency stockpile continues to drive product revenue growth and we are expecting to recognize most of the remaining revenue related to BARDA procurement from 'twenty 'twenty 1.
In addition, we continue to execute on our global expansion strategy with sustained revenue growth and expecting additional marketing approvals and lucrative market. During the next 18 months.
Yeah.
We continue to enroll new patients to the next expanded access program at leading U S burn centers with although 100 bandwidth dense who are already treated with nexobrid to date.
The expanded access program.
Who are proven.
We believe that the continued burn centers training on the use of Nexobrid through the next expanded access protocol will support Nexobrid launch upon approval in the U S.
Turning to the Nexobrid BLA.
So we were disappointed with the receipt of the surveil, we believe the FDA comments and concerns are manageable and can be addressed.
We will continue to partner with BARDA and very sad to leverage their vast experience and track record and regulatory demand.
To meet with the FDA as soon as possible and provide the F D a with a day.
The response to the CRA.
While it's premature to provide a specific timeline for the BLA Resubmission. We are actively preparing for a type a meeting with the FDA and will provide a further update at that time.
We remain optimistic about the prospect and long term potential for nexobrid and committed to bringing nexobrid to the U S market.
Expeditiously as possible.
Regarding our pediatric investigational plan.
We were thrilled to announce positive top line results from our phase 3 study of Nexobrid in children with severe thermal burns, which met all of its primary endpoints with high degree of statistically significant rain.
The enforcing the stronger clinical safety and efficacy profile of the product.
The data flow Nexobrid is clear and we strongly believe it will become an important treatment option for the pediatric patients.
Following those results.
We are planning to submit the data for label expansion in Europe, and other international markets. During 2022 and believe it will further enhance growth and global expansion of Nexobrid.
Turning to our newest clinical development program for non melanoma skin care sales.
We initiated an open label Phase 1.2 study of <unk> 5 product in battery cell carcinoma denied designed to evaluate safety and tolerability of the product using different schedules of administration.
This study will provide us with a preliminary evaluation of 005 efficacy and this could be very exciting program for us.
In tandem the first patients were enrolled in an investigator initiated phase II trial conducted at the soak on medical center and he's right designs.
Designed to evaluate the safety and efficacy.
Of course, they were 5 in removing non melanoma skin cancer.
We expect the data from both studies will be generated by the end of 'twenty 'twenty 1.
Lastly.
We were pleased to have the case series Doctor of passive cell carcinoma destruction by constant threat of portability enzymes and reaching Brahmi line, which is actually 005 published in a peer reviewed paper did.
The data provide a preliminary proof of concept that there was they were 5 may be a safe and effective distractive treatment for buses cell carcinomas.
And more importantly, establish the foundation for all of the non melanoma skin cancer clinical development.
Now.
I would like to turn the call over to blood flow.
Summary of our financials.
But.
Thank you shall on and good morning to our U S listeners and good afternoon to easily won.
First I'd like to reiterate our continued product revenue growth from both the U S market and the ex U S markets as Nexobrid continues to support our balance sheet.
We're looking to enhance our global expansion and expecting to have additional marketing approvals in new territories. This year.
2022.
I would like now to provide you with an update of our financial results for the second quarter and first half of 2021.
Revenues for the second quarter of 2021 increased 50% to $6.1 million compared to 4 million for the second quarter of 2020.
Product revenue for the quarter was $3 million, an increase of 175 per cent compared to 2022nd quarter product revenue of $1.1 million, primarily driven by BARDA procurement of Nexobrid for emergency stockpile and sales increase outside of the U S.
Gross profit for the quarter was $2.4 million or 39% of net revenue.
<unk> to gross profit of $1.2 million or 30% of net revenue for the pilot quarter.
Gross profit from product revenue was 57 per cent of NN.
Net revenues versus versus 48% in the second quarter of 2020, driven by increasing productivity new versus the fixed nature of our manufacturing cost.
Research and development expenses for the quarter or $2.7 million compared with $1.6 million for the second quarter of 2020.
The increase was primarily due to its correct clinical development program.
Selling general and administrative expenses for the quarter or $2.6 million compared with $2.3 million in the second quarter of 2020.
As a percentage of revenue SG&A expenses decreased 1400 basis points from 57% in the second quarter over last year to 43 per cent for the second quarter of 2021.
Operating loss for the quarter was $2.9 million compared with an operating loss of $2.7 million in the second quarter of 2020.
The company posted a net loss of $3.2 million or 12 cents per share for the quarter compared with a net loss of $3.1 million or 11 cents per share.
Second quarter of 2020.
Adjusted EBITDA for the quarter was a loss of $2 million compared with a loss of $2.1 million for the.
Second quarter of 2020.
Moving now to the first half of 2021 financial results.
Revenue for the first half of 2021 increased 41% to $11.9 million compared to $8.5 million in the first half of 2020.
Product revenue for the half were $5.9 million, an increase of 224 per cent compared to the $1.8 million from the first half of 2020.
Operating loss for the half was $4.8 million compared with an operating loss of $4.9 million from the.
First half of 2020.
The company's net loss for the half was 6 million or <unk> 22 cents per share.
<unk> was a net loss of $5.6 million or <unk> 20 per share for the first half of 2020.
Adjusted EBITDA for the half was the loss from $3.3 million compared with a loss of $3.9 million for the first half of 2020, an improvement of 14%.
This was driven by our product revenue growth and continued budget discipline, allowing us to advance our clinical development program on that's correct, while yielding this improvement.
Now moving to the balance sheet the hotline.
As of June 30.
This year <unk> had $17.2 million in cash and short term investments compared with $21.6 million as of December 31st 2020, and no debt.
Maybe 1 remained on budget utilizing $4.4 million in the first half of 'twenty 1 for its operational activities.
Throughout the remainder of 'twenty 1 the company will continue to invest primarily in research and development efforts for its correct.
The plant Nexobrid BLA resubmission and its related ongoing development programs will be funded by BARDA.
We now expect cash used for 'twenty, 1 to be in the range of 9 to 11 million.
Our financial guidance also assumes a day.
19 dynamics do not force and including the impact of the death of volume in the second half of the year.
With that I've concluded my financial overview, I will now turn the call back to shell and Chevron.
Thank you boss.
We are excited by our prospects as a company we are a diversified pipeline with meaningful early and late stage products to support our continued growth for years to come on.
We have several tremendous opportunities ahead of us.
With that it is my pleasure to open the call for your questions.
Operator.
Tom If you would like to ask a question. Please press star 1 on your telephone keypad.
And if you have a question. Please press star 1 on your telephone keypad, we'll pause for just a moment.
Your first question comes from the line of Kevin did you hear with Oppenheimer.
Hey, guys. Thanks for taking our questions maybe first off on.
Congratulations on the pediatric data for Nexobrid.
Can you provide us an update on how to think about.
Hari you.
Our process in the U S. We believe that are on separate regulatory reform from the adult population.
Do you need any additional clinical data or other supporting information apart from <unk>.
Resolution, we see around from the adult population before filing.
Thank you for the question, Matt and Kevin.
As we communicated earlier, when we got to see how L and mentioned in our prepared remark, we believe that we can.
Ken at the day, the FDA concerns without additional are starting and we do have sufficient data given the robust clinical data package, we believe that nexobrid remain well.
Well positioned to become the standard of care.
And ready for approval, we are actively preparing together with our partners debt, He said and powder for a type a meeting with the FDA. This meeting can be requested within 3 months after the FDA regulatory action.
And typically scheduled within 30 days from application. That's the timeline timeframe. We are looking for so obviously, we are looking to do so.
As soon as possible.
And beyond that we are not going to comment on when the meeting schedule on and so on but we.
Glenn and we certainly update investors and analyst day.
The appropriate time on we have more clarity after this meeting.
That's where you actually answered my second question. My first 1 was actually in context to the pediatric population, which I believe is not included in the.
The following forward she received a C O L <unk>.
On the line.
Net part of strategy in the U S from pediatric population.
Yeah <unk>.
Adding the pediatric population any label expansion in the U S will be only after we will get that ball full day 1.
Adult BLA or the adult indication. This is a label extension currently rather liberating the pediatric data and the safety update we will provide the FDA as part of day, except Michelle Ash.
And leverage the pediatric data, where we have already approved but for <unk> I E in Irma and other international on the market for a label extension.
And then on the remainder in the U S. We are still.
As a reminder, in the U S. We have waived from pediatric investigation on plan.
Based on our prior discussion with FDA, we plan to submit this debt off the pediatric day keep study after we will finalize day adult review of the 5.
No. Thank you for that and then maybe just lastly.
On the <unk>.
Study, if you can call out there.
No dose about 100 patients are treated about 100 patients on compassionate use.
How many centers roughly have used.
<unk> under the expanded access.
Protocol and has that changed meaningfully over the last quarter or 2.
Yeah. So currently we have 21 active sites in the U S and we have about 3 to 5 additional sites in the process of initiation in the U S. We and I would like to reiterate that the expanded access program going on through.
Through approval and we will continue to enroll patients to this study and treat patients with Nexobrid teal debt.
Few of the BLA will are finalized.
And as I said, we already created over 100 burn victims to date and according to the protocol, we are able to extend to up to 30 sites and wait at least 200 patients on.
Under the current protocol.
Thank you for that.
Your next question comes from the line of Josh Jennings with Cowen.
Hi, good morning on Hall.
Thanks for taking the questions.
Okay.
Yeah.
Good morning.
Good morning, 2 questions.
Mr. Wang.
Come on.
<unk> talked about how the team is taking a leadership role on the deal on the Resubmission.
Basically.
Hello.
Yes.
Mobile will draw on others.
We will know exactly on this.
Sure.
Thank you for the question.
So in general on bringing Nexobrid to the U S market is a joint collaboration or junk project as you know of very sale as the commercial the U S. Commercial personnel once the rights in North America part of that.
I'll take a day 1.
Ones that provide support in funding and of course, many ones on the IP and the extensive experience on a.
Nexobrid.
We have vast experience with nexobrid given the 20 years of history with the development of Nexobrid very sales have a clinical regulatory and operation team with great deal of experience.
And our success on the regulatory front.
So we are in a great position to leverage very sad to lead the regulatory front.
With our years of experience with Nexobrid and bothered us, especially on the matter consultants, who bring their personal experience.
This is John collaboration providing us with the confidence that we have the best team to achieve the BLA approval. So we feel good about the best going forward.
And we have a great deal of confidence with Nexobrid robust clinical data and we look forward to bringing this product into the U S market.
Understood.
On SCS.
Most of them historically.
On the possibly starting second half less than 2018 results on analysis.
On the first trial.
Favorable results.
Any updated thoughts on timeline starting in the second trial on sell in and approval timelines on assets.
I as I mentioned in the prepared remark, we plan to complete the enrollment of the ongoing phase 2 study by year end and to generate data from the pharmacology study by year end and if you meet this goal we will have data read out.
From the ongoing phase 2 study anticipated in the first half of 'twenty 2 the data that will be generated from those 2 ongoing trials together with the data generated to date, which is the brio phase 2 study and day for our clinical studies will be guidance, calling gulfport.
Debt for a discussion with the FDA before we move forward to the next day Air and.
Study in the U S in order to align and get FDA concurrence from the next stage of development in the U S.
Got it.
Just in terms of the pharmacology studies.
And when you have those been delayed this year.
No.
Either 1.
Pivotal program.
On the Malibu.
I'll do that pretty quickly.
The zone pathway.
Yeah.
Under this day from a quality study is an open label.
Study assessing the pharmacological effect of FX and up to 15% both values and defuse we already enrolled several patients to this study and this study will provide us with a better understanding of what is happening in the wound bed fueling and after debt at <unk> S correct and.
Specifically it will enable us to assist effect on reduction of biofilm belden.
<unk> Chan of inflammation and initiation of healing process all of those data.
Data points on measurement from.
<unk> with additional clinical benefits of <unk>, correct, and we would like to have this debt as part of the discussion with debt because we would like to incorporate the best price out of the study or some of that is out of the study also is the measurement in the next.
A clinical study in the U S.
Understood.
Sure.
And once again, if you'd like to ask a question. Please press star 1 on your telephone keypad again. The Star then the number 1 on your telephone keypad.
Your next question comes from the line of Sam Pakula from Rama Cat with H C. Wainwright.
Thank you this is RK from history.
Right.
Good morning turnaround on a go.
Hmm or a question on the bread.
And on 1 of the Sun sales.
1 of the issues with the vitamin C are almost day.
[noise] inspection.
Of your plants.
Israel in Taiwan, So what's the situation there you know all this.
Oh, Dear resolving them no debt.
Childhood stuffs.
Any updates there.
Yeah. So in terms of day inspections, that's not a discussion that we have been engaged with the high Def day at.
At this point.
We can.
Can resubmit the package and the inspections that need to occur prior to the approval.
And since the situation is dynamic worldwide and also the instruction and the FDA are changing on a monthly basis, we will have to monitor it carefully and see the vehicles all the tools that the fda's implementing in order to get day, a backlog that they have.
With inspections domestically and foreign inspection going forward.
Thank you for that and then on the.
They don't fly molecule.
When should we expect data from that study.
Yes.
As communicated previously we plan to have data from both studies the phase 1.2 study in the U S and the I T study conducted in Israel by year end 2021.
Okay. Thank you thanks for taking my questions.
Thank you there are no further questions in queue.
I'll now turn the call back over to CEO Sharon. Please go ahead.
Thank you very much.
Thank you everyone for joining us today and for your continued interest in <unk>.
Look continuing to executing on our strategy and bringing new therapies to the market and to update you again on our next update call. Thank you very much and advocate day.
Thank you.
Thank you for participating on today's conference call you may now disconnect.
Yeah.
Okay.
[music].
Okay.
[music].
[music].
[music].
Good day, and thank you for standing by welcome to the Kiichi them anyway on 2021conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During this session you will need to press star 1 on your telephone please be advised that.
Today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker today, Jeremy Feffer. Please go ahead.
Thank you Don and good morning, everyone earlier today <unk> issued a press release announcing financial results from the second quarter of 2021, you may access that release on the Companys website under the investors debt with US today are Sharon Malka, Chief Executive Officer of Madewell, and Boaz Gur Lavie Chief Financial Officer.
Management's prepared remarks, we will open the call for Q&A.
To begin I would like to remind everyone that statements made during this call, including the Q&A session relating to <unk> expected future performance future business prospects or future events or plans are forward looking statements as defined under the private Securities Litigation Reform Act of 1095, although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions.
Actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecast due to the impact of many factors beyond the control of megawatt 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 the cautionary notes set forth in today's press release.
Well as the risk factors set forth in <unk> 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 the property of medley wound on any recording or rebroadcast is expressly prohibited without the written consent of network now I would like to turn the call over to Sharon Malka, Chief Executive officer of megawatt shrunk.
Thank you Jeremy.
Good morning to all other U S gets announced and good afternoon listener and he's right.
Come through on our second quarter 2021 conference call to discuss our financial results and business highlights.
The second quarter of 2021, and the subsequent weeks have been eventful from a clinical and commercial standpoint, we had a positive EBITDA at MFS menthol S kind of phases phase 2 study M.
F D a feedback on Nexobrid BLA and back those out of Nexobrid phase III pediatric study.
Commercially we continue to generate product revenue growth compared with the flywheel, we didn't buy the procurement of nexobrid by buyback and revenues continued growth out of U S.
On the clinical front.
We are pleased with the progress again across each of our ongoing clinical programs and are encouraged by the positive clinical data from both S kayaks and Nexobrid.
Let me begin first with a few of our clinical development program.
He most recently and now the best possible outcome of the interim assessment for E. U S phase II adaptive design study.
Recall that this study aims to assess the safety and efficacy of <unk> correct for the day, great men on things like I said I have.
Compared to gel vehicle and non surgical site of care.
On the interim assessment Sep 2 debt the mine, where the sample size adjustment is required to maintain conditional power for this study.
The interim assessment had 3 potential outcomes.
Continuation of the thrive at its current sand per site.
An increase in the sample size to Paolo the pile on.
Is that an end of the file due to futility.
Yeah.
They ain't doing them on test men conducted after about 80 patients approximately 2 third of the origin Allianz ultimate target of 120 patients completed the debridement treatment.
Based on the independent data monitoring committee's recommendation.
The interim assessment is debt to positive takeaway fast.
No enrollment sample size changes are necessary to maintain the pre specified statistical power of 80% on great. Though for the studies primary endpoint of incidence of complete debridement compared to the gel vehicle.
This positive outcome means that the studies that ball up at least side at the planned enrollment of 120 patients and can continue without the need to add more patients.
As a reminder.
We had previously they deal with the enrollment target from 174 patients do I have a 20 patient. So we are happy with day independent data monitoring committee's recommendation confirming that change.
Second no safety concerns were identified in the study population, which is another positive it with debt.
These successful interim assessment suggests that S. Correct is a safe and tolerable and provides positive signal that increased our confidence that <unk> may prove to be an effective non surgical therapy for the bride meant of corn on corn.
We anticipate completing full enrollment in this study by end of 2021 with data readout anticipated in the first half of 'twenty 2.
Also on our ethics program, we have enrolled our first patient.
In our phase 2 pharmacology study.
And anticipate data from that study later this year.
As a reminder, this is a phase 2 open label single arm study designed to evaluate the clinical performance safety and pharmacology effect of ex cat ex in the deployment of flow like ourself, I E venous leg ulcers and diabetic foot ulcers in up to 15 patients.
Okay.
The data generated to date for S. Capex have been very encouraging.
We published a peer reviewed paper summarizing there is that off a successful phase 2 assessor blinded study of our first generation <unk> correct.
<unk> achieved its efficacy and safety endpoints.
That's correct.
Well tolerated and has demonstrated safety and efficacy in the debridement of various chronic and hard to out weighted ones within the few daily applications.
Earlier this year, we completed successfully at comparator in vivo study designed to evaluate the debridement efficacy, that's correct and the commercial collagenase enzymatic debridement agent in a pulse on how to wield more then.
The study.
Concluded that S. Correct. It meant was clinically superior to the commercially available collagenase agent in removing eschar in this model.
The data from this trial together with a positive interim assessment gave us confidence in both of our current ongoing phase II trials of second generation S guidance, and we look forward to data from both of these drugs.
With a clear unmet medical need for a nonsurgical rapid and effective debridement agent in the outpatient setting <unk> has the potential to improve on the current standards of care and have a meaningful impact on corn and corn from management.
Turning to Nexobrid.
On the commercial front BARDA procurement for emergency stockpile continues to drive product revenue growth and we are expecting to recognize most of the remaining revenue related to BARDA procurement in 2021.
In addition, we continued to execute on our global expansion strategy with sustained revenue growth and expecting additional marketing approvals and lucrative market. During the next 18 months.
Okay.
We continue to enroll new patients to the next expanded access program at leading U S burn centers with although 100 been victims, who are already treated with nexobrid to date.
The expanded access program.
Who are proven.
We believe that the continued burn centers training on the use of Nexobrid through the next expanded access protocol will support Nexobrid launch upon approval in the U S.
Turning to the Nexobrid BLA.
So we were disappointed with the receipt of the theater L. We believe the FDA comments and concerns.
Manageable and can be addressed.
We will continue to partner with about that and very cell to leverage their vast experience and track record and regulatory demand.
To meet with the FDA as soon as possible and provide the FDA with a detailed response to the CRM.
While it's premature to provide a specific timeline for the BLA Resubmission. We are actively preparing for a type a meeting with the FDA and will provide a further update at the appropriate time.
We remain optimistic about the prospect and long term potential for nexobrid and committed to bringing nexobrid to the U S market as expeditiously as possible.
Like I think I hope idiotic investigation on plan.
We're thrilled to announce positive top line results from our phase 3 study of Nexobrid in children with severe thermal burns, which met all of its primary endpoints with a high degree of statistical significant rain.
The enforcing the stronger clinical safety and efficacy profile of the product.
The data flow Nexobrid is clear and we strongly believe it will become an important treatment option for the pediatric <unk> patients.
Following those results.
We are planning to submit the data for label expansion in Europe, and other international markets. During 2022 and believe it will further enhance growth and global expansion of Nexobrid.
Turning to our newest clinical development program for non melanoma skin care sales.
We initiated an open label Phase 1.2 study of <unk> 5 product and bad debt cell carcinoma denied designed to evaluate safety and tolerability of the product using different schedules of administration.
This study will provide us with a preliminary evaluation of 005.
Efficacy and this could be very exciting program for us.
In tandem debt.
Patients were enrolled in an investigator initiated phase II trial.
So look on medical center and is that.
Designed to evaluate the safety and efficacy.
Of course, they were 5 in removing non melanoma skin cancer.
We expect the data from both studies will be generated by the end of 'twenty 'twenty 1.
Lastly.
We were pleased to have the case series data of passive cell carcinoma destruction by a constant threat of portability enzymes and reaching Brahma line, which is actually 005 published in a peer reviewed paper.
The data provide a preliminary proof of concept that there was they were 5 may be a safe and effective distracting treatment for buses cell carcinomas and more importantly, establish the foundation for our non melanoma skin cancer clinical development.
Now.
I would like to turn the call over to Bob for a summary of our financials.
But.
Thank you shall on and good morning to our U S listeners and good afternoon to easily won.
First I'd like to reiterate our continued product revenue growth from both the U S market.
On the ex U S markets as Nexobrid continues to support our balance sheet.
We're looking to enhance our global expansion and expecting to have additional marketing approvals in new territories. This year that's throughout 2022.
I would like now to provide you with an update of our financial results for the second quarter and first half of 2021.
Revenues for the second quarter of 2021 increased 50% to $6.1 million compared to $4 million for the second quarter of 2020.
Product revenue for the quarter was $3 million, an increase of 175 per cent compared to 2022nd quarter product revenue of $1.1 million.
Not really driven by BARDA procurement of Nexobrid for emergency stockpile and sales increase.
Sales of New York.
Gross profit for the quarter was $2.4 million or 39% of net revenue compared to a gross profit of $1.2 million or 30% of net revenue for the pilot quarter.
Gross profit from product revenue was 57% of net revenues versus 48% in the second quarter of 2020, driven by increasing product revenue versus the fixed nature of our manufacturing cost.
Research and development expenses for the quarter or $2.7 million compared with $1.6 million for the second quarter of 2020.
The increase was primarily due to <unk> clinical development program.
Selling general and administrative expenses for the quarter or a $2.6 million compared with $2.3 million in the second quarter of 2020.
As a percentage of revenue SG&A expenses decreased 1400 basis points from 57% in the second quarter over last year to 43% for the second quarter of 2021.
Operating loss for the quarter was $2.9 million compared with an operating loss of $2.7 million in the second quarter of 2020.
The company posted a net loss of $3.2 million or 12 cents per share for the quarter compared with a net loss of $3.1 million per 11 cents per share for the second quarter of 2020.
Adjusted EBITDA for the quarter was a loss of $2 million compared with a loss of $2.1 million for the second quarter of 2020.
Moving now to the first half of 2021 financial results.
Revenue for the first half of 2021 increased 41% to $11.9 million compared to $8.5 million in the first half of 2020.
Product revenue for the half were $5.9 million, an increase of 224% compared to the $1.8 million from the first half of 2020.
Operating loss for the half was $4.8 million compared with an operating loss of $4.9 million in the first half of 2020.
The company's net loss for the half was $6 million on 22 cents per share compared with a net loss of $5.6 million or <unk> 20 per share for the first half of 2020.
Adjusted EBITDA for the half was the loss from $3.3 million.
<unk> was a loss of $3.9 million for the first half of 2020, an improvement of 14%.
This was driven by our product revenue growth and continued budget discipline, allowing us to advance our clinical development program on that's correct, while yielding this improvement.
Now moving to the balance sheet the hotline.
As of June 30.
This year, maybe we had $17.2 million in cash and short term investments.
On page was $21.6 million as of December 31, 2020.
Debt.
Maybe 1 remained on budget utilizing $4.4 million in the first half of 'twenty 1 for its operational activities.
Throughout the remainder of 'twenty 1 the company will continue to invest primarily in research and development efforts for <unk> correct.
The plan Nexobrid BLA Resubmission related ongoing development program will be funded by BARDA.
We now expect cash used for 'twenty, 1 to be in the range of $9 million to $11 million.
Our financial guidance also assumes that the COVID-19 dynamics do not force and including the impact of the Delta variant in the second half of the year.
With that I've concluded my financial overview, I will now turn over the call back to Sean Sean.
Thank you boss.
We are excited by our prospects as a company we are a diversified pipeline with meaningful early and late stage products to support our continued growth for years to come.
We have several tremendous opportunities ahead of us.
With that it is my pleasure to open the call for your questions.
Operator.
At this time, if you would like to ask a question. Please press star 1 on your telephone keypad again, if you have a question. Please press star 1 on your telephone keypad, we'll pause for just a moment.
Okay.
Your first question comes from the line of Kevin <unk> with Oppenheimer.
Hey, guys. Thanks for taking our questions may be first of all on.
Congratulations on the pediatric data from Mexico, Brad.
Can you provide us an update on how to think about.
Regulatory on you.
The process in the U S. We believe that are on separate regulatory reform from the adult population.
Do you need any additional clinical data or other supporting information.
From.
Resolution <unk> from adult.
Operation before filing.
Thank you for the question Kevin.
Kevin.
As we communicated earlier, when we got to see how L and mentioned in our prepared remark. We believe that we are.
Ken at the day.
The FDA concerns without additional study and we do have sufficient data given the robust clinical data package, we believe that next day, but remain.
Well positioned to become the standard of care.
And ready for approval, we are actively preparing together with our partners 30 sales and powder for a type a meeting with the FDA. This meeting can be requested within 3 months after the FDA regulatory action.
And typically schedule within the 30 day and storm application. That's the timeline timeframe. We are looking for so obviously, we are looking to do so.
As soon as possible.
And beyond that we are not going to comment on when the meeting is scheduled and so on back.
Glenn and we certainly update investors and analyst.
Therefore for a time on we have more clarity after this meeting.
No. That's fair you actually answered my second question, but my first 1 was actually in context to the pediatric population, which I believe is not included in the following <unk> received a C O L. <unk> an update on the leg of our strategy in the U S from pediatric population.
Yeah <unk>.
Adding the pediatric population any label expansion in the U S will be only after we will get that approval full day 1.
A BLA or the adult indication. This is a label extension currently we are liberating the pediatric data in the safety uptake, we will provide the FDA as part of the Resubmission.
And leverage the pediatric data, where we have already approved but for <unk> I E in Irma and other international on the market for label extension.
And then on the remainder in the U S. We are still.
As a reminder, in the U S. We have waived from pediatric investigation on plan. So.
Based on our discussion with FDA, we plan to submit this debt off the pediatric day Keith study after we will finalize the adult review of the 5.
Thank you for that and then maybe just lastly.
On the next study if you can call out debt.
No dose about 100 patients are treated about 100 patients on compassionate use.
How many centers roughly have used.
Your next operating under the expanded access.
Protocol on has that changed meaningfully over the last quarter or 2.
Yeah. So currently we have 21 active sites in the U S and we have about 3 to 5 additional sites in a process of initiation in the U S.
I would like to reiterate that the expanded access program going on through.
Through approval.
And we will continue to enroll patients to this study and treat patients with Nexobrid Teal day review of the BLA will are finalized.
And as I said, we already created over 100 victims to date and according to the protocol, we are able to extend to up to 30 sites and wait at least 200 patients on.
Under the current protocol.
Thank you for that.
Your next question comes from the line of Josh Jennings with Cowen.
Hi, Good morning question on the hall sensors in the questions can you hear me okay.
Yes.
Good morning.
Good morning.
On lesser grade.
Net income loans held for sale talked to allow the team is taking a leadership role on the dealer resubmission.
Basically.
In others.
Mobile growth numbers overall unchanged.
And that's what exactly we mean by the leadership group.
Thank you for your question.
So in general, bringing nexobrid to the U S market is a joint collaboration or joint project as you know of very sale as the commercial the U S. Commercial partner wants that I'd say North America part of that.
Yeah.
On the ones that provide support in funding and of course, many loans on the IP and the extensive experience of Nexobrid.
Nexobrid, we have vast experience with nexobrid given the 20 years of history with the development of Nexobrid very sales have a clinical regulatory and operation team with great deal of experience.
And success on the regulatory front.
So we are in a great position to leverage very sad to lead the regulatory front.
Our years of experience with Nexobrid and bothered us special matter consultants, who bring their personal experience.
And this John collaboration and providing us with the confidence that we have the best team to achieve the BLA approval. So we feel good about the path going forward.
And we have a great deal of confidence with Nexobrid robust clinical data and we look forward to bringing this product into the U S market.
Understood.
On SCS.
Even more from historically.
The popular study secondly, still on trial for us.
And results in an analysis.
On the first trial.
Favorable results.
Any updated thoughts on timing side on the second trial accelerated approval timelines on that.
As I mentioned in the prepared remark, we plan to complete the enrollment of the ongoing phase 2 study by year end and to generate data from the pharmacology study by year end.
And if we meet this goal we will have data readout from the ongoing phase 2 study anticipated in the first half of 'twenty 2 the data that will be generated from those 2 ongoing trials together with the data generated to date, which is the trial phase II study and the preclinical.
<unk> will be guidance, calling gulfport debt for a discussion with the FDA before we move forward to the next day.
The study in the U S in order to align.
And get FDA concurrence from the next stage of development in the U S.
Got it got it.
Just in terms of the pharmacology.
And when you have the diluted share.
No.
Net.
On the pivotal program.
On the pharmacology studies.
Sure.
I'll do that quickly.
Goodwill pathway.
As a reminder, this day from a quality study is an open label.
The study assessing the pharmacological effect of FX in up to 15%, both <unk> and <unk>, we already enrolled several patients to this study.
This study will provide us with a better understanding of what is happening in the wound bed fueling and after debt debridement with S. Correct and most specifically it will enable us to assess effect on reduction of Biopharma burden reduction of inflammation and initiation of <unk>.
Healing process.
All of those.
A data point so measurement.
Provide us with additional clinical benefit of S. Correct, and we would like to have this debt as part of the discussion with the FDA because we would like to incorporate the best price out of the study or some of that is out of the study also is measurement in the next.
A clinical study in the U S.
Understood.
On.
And once again, if you'd like to ask a question. Please press star 1 on your telephone keypad.
MSR and the number 1 on your telephone keypad.
Your next question comes from the line of Sam.
<unk> Rama Rama cap with H C Wainwright.
Thank you this is James on the head.
Good morning her on that.
My question on that.
Brad.
And on 1 of the so 1.
1 of the issues with the.
On the CRM.
Inspection.
Of your plants.
But Israel in Taiwan so.
What's the situation. There is you know all this.
EBITDA resolving.
On the childhood stuffs.
Any updates there.
Yeah. So in terms of day inspections, that's not the discussion that we have been engaged with the FDA at this point.
We.
Can resubmit the package and day inspection does need to occur prior to the approval.
And since the situation is dynamic worldwide and also the instruction and the FDA are changing on a monthly basis, we will have to monitor carefully and see the vehicles all the tools that the fda's implementing in order to GAAP the backlog they have.
With inspections domestically and foreign inspection going forward.
Thank you for that and then.
On <unk> molecule.
Sure.
Should we expect data from that study.
Yes.
As communicated previously we plan to have data from both studies the phase 1.2 study in the U S and the IIT study conducted in Israel by year end 2021.
Okay. Thank you thanks for taking my questions.
Thank you there are no further questions in queue.
I'll now turn the call back over to CEO Sharon. Please go ahead.
Thank you very much thank.
Thank you everyone for joining us today and for your continued interest in <unk>.
Look continuing to executing on our strategy and bringing new therapies to the market and to update you again on our next update call. Thank you very much and have a great day.
Thank you.
Thank you for participating on today's conference call you may now disconnect.