Q4 2023 MediWound Ltd Earnings Call
Operator: Good day, and welcome to Mediwound's fourth quarter and full year 2023 earnings call. Today's conference is being recorded. If you require operator assistance, please press star then zero.
[laughter].
Speaker Change: Good day, and welcome to Medi wounds fourth quarter and full year 'twenty forty-three earnings call.
Speaker Change: Today's conference is being recorded if you require operator assistance. Please press Star then zero.
Gaia Shamus: At this time, I would like to turn the conference over to Gaia Shamus of Lifesci Advisors. Please go ahead. Thank you, Operator, and welcome, everyone. Today, before the market opened, Mediwound issued a press release announcing financial results for the fourth quarter and full year and December 31, 2023. You may access that release on the company website under the Investors tab. With us today are Ofer Gonen, Chief Executive Officer of Mediwound, Hani Luxenburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our preferred 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 Mediwound's 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 1995.
Speaker Change: At this time I would like to turn the conference over to Gaia Seamus.
Gaia Seamus: Lifestyle advisors. Please go ahead.
Gaia Seamus: Thank you operator and welcome everyone.
Speaker Change: The Florida market opened but he wanted to issue a press release announcing financial results for the fourth quarter and full year ended December 31st 2020.
Gaia Seamus: You may access that's really on the company website under the Investor tab with US today are all first one N Chief Executive officer of somebody along plenty Luxembourg, Chief Financial Officer, and Barry Welcome, Sean Executive Vice President of strategy and corporate development.
In our prepared remarks, well 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 somebody wants to expected future performance future business prospects or future events or plans are forward looking statements as defined under the private.
Gaia Seamus: The Securities Litigation Reform Act of 1995, although the company believes that 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.
Gaia Shamus: Although the company believes that 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 Mediwound. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise.
Gaia Seamus: Beyond the control of the smartphones.
The company has 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 as well as actually factor.
Gaia Shamus: Participants are directed to the cautionary notes set forth in today's press release, as well as the at-risk factors set forth in Mediwound's 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 Mediwound, and any reporting or rebroadcast is expressly prohibited without the written consent of Mediwound. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of Mediwound. Okay?
Gaia Seamus: Factor in that as far as in maybe one and all the reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward looking statements.
Speaker Change: The conference call is the property off my demand and annual reporting or rebroadcast is expressly prohibited without the written consent of somebody lunch now I would like to turn the call over to offer Gonna N Chief Executive Officer after 91 offer.
Ofer Gonen: Thank you, Gaia, and good morning, everyone. Welcome to Mediwound's fourth quarter and full year 2023 conference call. Joining me today are Hani Luxenburg, our Chief Financial Officer, and Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development. Following our discussion of the financial results and business highlights, we will open the call for questions. I'm excited to share that we had a remarkable year.
Gonna N: Thank you Guy and good morning, everyone welcome to maybe want to fourth quarter and full year 2023 conference call.
Gonna N: Joining me today are honey Luxemburg, our chief Financial Officer, and Barry <unk> Walton Sun, our executive Vice President of strategy and corporate development.
Speaker Change: Following our discussion over the financial results and business highlights we will open the call for questions.
Speaker Change: I'm excited to share that we had a remarkable year.
Ofer Gonen: Our unwavering commitment to executing our commercial strategy for Nexobreed, coupled with our substantial operational excellence, has yielded revenue of $19 million. Furthermore, we are making significant progress towards initiating our Phase 3 trial of Escorex, a product that targets a $2 billion market. Utilizing the same proven active pharmaceutical ingredient as Nexobrid, Escarex has demonstrated superiority over the current market leader in Phase II studies. Let's begin our discussion with the major milestones we have achieved with Nexobreed in 2023. Nexobeats had an exciting year on a number of fronts, generating $19 million in revenue, which was primarily driven by its commercial availability in the United States, Japan, and India. Additionally, it received approval for pediatric use in Europe and is currently under review by the FDA for pediatric use as well. Moreover, NexoBrid continues to benefit from federal funding in the United States supporting both emergency preparedness and ongoing research and development activities. However, the demand for NexoBrid currently exceeds our production capabilities.
Speaker Change: Unwavering commitment to executing our commercial strategy of Nexobrid, coupled with our substantial operational excellence has yielded revenue of $19 million.
Speaker Change: Furthermore, we are making significant progress towards initiating our phase III trial of S. Correct.
Speaker Change: <unk>, which targets a 2 billion dollar bucket.
Speaker Change: Utilizing the same proven active pharmaceutical ingredient as nexobrid.
Speaker Change: That's correct has demonstrated superiority over the current market leader in phase II studies.
Speaker Change: Let's begin on discussion with the major milestones, we have achieved with nexobrid in 2020 three.
Speaker Change: Yeah.
Speaker Change: Mexico had an exciting year on a number of fronts.
Speaker Change: Generated $19 million in revenue, which was primarily driven by its commercial availability in the United States, Japan and India.
Speaker Change: Additionally, it received approval for pediatric use in Europe and is currently under review by the FDA for people.
Speaker Change: Yatra accuse us well.
Speaker Change: Moreover, Nexobrid continues to benefit from federal funding in the United States.
Speaker Change: Boating, both emergency preparedness and ongoing research and development activities.
The demand for Nexobrid currently exceeds our production capabilities. We are actively scaling up our GMP compliance state will be out facility, which is on schedule for completion by mid 2024.
Ofer Gonen: We are actively scaling up our GMP compliant state-of-the-art facility, which is on schedule for completion by mid-2024. We anticipate achieving full production capacity in 2025. This expansion will enhance our production capabilities six-fold, enabling us to fulfill the increasing global demand for NexoGrid. Now, let's discuss each of the drivers for nexobreed growth in further detail. Nexablit was introduced to the U.S. market by our partner VeriCell at the end of the third quarter.
Speaker Change: We anticipate achieving full production capacity in 2025.
Speaker Change: This expansion will enhance our production capabilities six volt, enabling us to fulfill the increasing global demand for Nexobrid.
Speaker Change: Now, let's discuss each of the drivers for Nexobrid growth.
Speaker Change: Further detail.
Speaker Change: Next up with was introduced to the U S markets by our partner very so at the end of the third quarter.
Ofer Gonen: Verisel is focused on building a strong foundation for NexoBrid by supporting P&T committee approvals. By the end of 2023, more than 50 burn centers submitted packages to their P&T committees, out of which over 25 centers gained committee approvals, and nearly 20 centers placed initial product orders. Most notably, the clinical outcomes and the feedback from burn surgeons regarding the initial patient treated with Nexogrid have been extremely positive. This is a strong indicator of Nexobreed's potential to change the standard of care in eschar removal for patients with severe burns.
Speaker Change: Very serious focus on building a strong foundation for Nexobrid by supporting PMT Committee approvals.
Speaker Change: At the end of 2023 more than 50 burn centers submitted packages to their Pnp committees out of which over 25 centers gains committee approvals and nearly 20 centers placed initial product orders.
Speaker Change: Most notably the clinical outcomes and the feedback from Byrne says Bill intelligence regarding the initial patient treated with nexobrid have been extremely positive.
Speaker Change: This is a strong indicator of nexobrid potential to change the standard of care in eschar removal for patients with severe burns.
Ofer Gonen: As for commercial access, CMS granted NexoBrid a permanent J-code and transitional pass-through payment status, which became effective in January 2024. NexoBrid has also successfully launched in two major markets; Japan, through our partnership with Kaiken Pharmaceuticals, and in India through BSV. Both launches have been progressing as planned and have generated further demand for next. In Europe, we expanded our commercial activity by establishing a collaboration with Polymedics, which will further facilitate greater nexobrit usage in Germany, Austria, Belgium, the Netherlands, and Luxembourg. The transformative potential of Nexovrid as the new standard for treating severe burns in emergency scenarios was highlighted during the war in Israel.
Speaker Change: Asphalt commercial axis CMS granted nexobrid permanent J code and transitional pass through payment status. This became effective in January 2024.
Speaker Change: Yeah.
Speaker Change: Nexobrid has also successfully launched.
Speaker Change: In two major markets, Japan through our partnership with <unk> Pharmaceuticals, and in India through BSB.
Speaker Change: Both launches have been progressing as planned and have generated further demand for nexobrid.
Speaker Change: In Europe, we expanded our commercial activity based stablish ingot collaborations with fully medics, which will further facilitate greater nexobrid usage in Germany, Austria, Belgium, the Netherlands and Luxembourg.
Speaker Change: Formative potential of Nexobrid as the new standard of treating of severe burns.
Emergency scenarios was highlighted during the war in Israel.
Ofer Gonen: Last October, we allocated our entire non-U.S. Nexobreed inventory to meet the critical demand for treating mass casualty burn incidents. Nexobreed has been instrumental in saving lives across both military and civilian sectors. This successful development has sparked increased interest from various global governments in stockpiling Nexobreed for future use. Our partnership with the U.S. government remains solid.
Speaker Change: Last October we allocated our entire non U S nexobrid inventory to meet the critical demand for treating mass casualty burn incidents.
Speaker Change: Nexobrid paved instrumental in saving lives.
Speaker Change: Across both military and civilian sectors there.
Speaker Change: The successful development has sparked increased interest from various global governments in stockpiling nexobrid for future emergencies.
Speaker Change: Our partnership with the U S government remains solid we have secured $13 million R&D grant.
Ofer Gonen: We have secured a $13 million RMT grant from the U.S. Department of Defense to develop and manufacture a new formulation for Nexobrid that is stable at room temperature. This innovation is intended for the U.S. Army as a non-surgical treatment for traumatic burns on the battlefield. Additionally, we have received an extra $10 million from BARDA. This funding is designated for the replenishment of expired products previously procured, for emergency readiness, along with supporting further R&D efforts. We have also received European Commission approval to broaden the necrophobies label in Europe to include patients of all ages. Additionally, a supplemental BLA for pediatric use has been accepted for review by the FDA, with a decision anticipated later this year. Considering the pediatric patient,
Speaker Change: The U S department of defense to develop and to manufacture a new formulation for Nexobrid that is stable at room temperature.
Speaker Change: This innovation is intended for the U S Army as a non surgical treatment for somatic burns on the battlefield.
Speaker Change: Additionally, we have received an extra $10 million for BARDA.
Speaker Change: This funding is designated for the replenishment of expired product previously procured.
Speaker Change: For our message readiness, along with supporting further R&D efforts.
Speaker Change: We have also received European Commission approval to broader Nexobrid label in Europe to include patients for all ages.
Speaker Change: Additionally.
Speaker Change: Elemental BLA for pediatric use has been accepted for review by the FDA with a decision anticipated later this year.
Speaker Change: Considering the pediatric patients.
Ofer Gonen: Consider that those patients represent approximately 40% of all burn victims, this approval could substantially expand Nexobrid's market reach. Overall, we are very pleased with the tremendous progress we have made with NexoBrit this year and the strong global demand we have experienced. As we enter 2024, the influx of orders for the entire year has allowed us to project revenues of $24 million. Looking ahead, we anticipate significant revenue growth exceeding 40% in the coming years, with revenue projections of $30 million for 2025 and $39 million for 2022. Now I would like to discuss Escoret.
Speaker Change: Consider that those patients represent approximately 40% of all burn victims disapproval could substantially expand nexobrid the market reach.
Speaker Change: Overall, we are very pleased with the tremendous progress we have made with mix a bit this year.
Speaker Change: And the strong global demand we have experienced.
Speaker Change: As we enter 2024, the influx of order flow.
Speaker Change: For the entire year has allowed us to project revenues of $24 million.
Speaker Change: Looking ahead, we anticipate significant revenue growth exceeding 40% in the coming years with revenue projection of $30 million for 2025 and $39 million for 2026.
Speaker Change: Now I would like to discuss that's correct.
Ofer Gonen: We are fully aligned with both FDA and EMA on the phase three protocol, evaluating S-Corrects in patients with venous leg alpha. The protocol submission is planned for the first half of this year, and we anticipate initiating the trial in the second half of 2024. This will be a multicenter, prospective, randomized, and placebo-controlled global trial. We aim to enroll 216 patients in over 40 sites that will be randomized one-to-one to receive either SRX or placebo. The trial will focus on two co-primary endpoints, the incidence of complete debridement and the indication of the incidence of wound closure.
Speaker Change: We are fully aligned with both FDA and EMA on the phase III protocol evaluating S correct in patients with venous leg ulcers.
Speaker Change: The protocol submission is planned for the first half of this year and we anticipate initiating the trial in the second half of 'twenty 'twenty four.
Speaker Change: This will be a multicenter prospective randomized and placebo controlled global trial.
Speaker Change: We aim to enroll 200 within 16 patients in over 40 sites that will be randomized one to one to receive either S. Correct.
Speaker Change: Placebo.
Speaker Change: The trial will focus on two co primary endpoints the incidence of complete debridement and the indication of the incidence of wound closure.
Barry J. Wolfenson: An interim assessment is scheduled after 67% of the patients have completed the trial. The study is estimated to take about 24 months to complete. The design of the trial is very similar to our successful phase two studies, and the chosen sample size provides 90% statistical power. We were excited to recently report the results of a head-to-head comparative analysis of EscaRex versus Sampson. And now I will hand it over to Barry, who will elaborate further. Barry, thanks, Ofer.
Speaker Change: An interim assessment is scheduled after 67% of the patients have completed the trial.
The study is estimated to take about 24 months to complete.
Speaker Change: The design of the trial is very similar to our successful phase two studies.
Speaker Change: And the chosen sample size provides 90% statistical power.
Speaker Change: We were excited to recently report the results of a head to head comparative analysis of S correct versus Santa.
Speaker Change: And now I will hand, it over to Barry who will elaborate further.
Barry.
Barry: Thanks Ofer.
Barry J. Wolfenson: In our Phase 2 study, SCAR-X demonstrated superior results. Sansyl collagenase ointment, approved in the 1960s, is the current leading treatment for enzymatic debridement of chronic wounds, generating over $360 million in sales in the United States. S-Correx, a complex mixture of enzymes targeting different components of non-viable tissue and wounds, typically works within one to two weeks. In contrast, Sancil focuses solely on collagen and often needs four to eight weeks of debridement, usually alongside sharp debridement.
Barry: In our phase II study, that's correct demonstrated superior results cancel collagenase ointment approved in the 19 sixties.
Barry: Current leading treatment for enzymatic debridement of chronic wounds generating over $360 million in sales in the United States.
Barry: That's correct a complex mixture of enzymes targeting different components of nonviable tissue and wound typically works within one to two weeks.
Barry: <unk> Santo focuses solely on collagen and often needs four to eight weeks of debridement, usually alongside sharp debridement.
Barry J. Wolfenson: The results of the head-to-head analysis are compelling and were achieved with robust statistical significance. Starting with the incidence of complete debridement, 63% of patients achieved complete debridement within two weeks with SCAR-X versus 0% with SAMHSA. Importantly, the estimated median time it took for SCAR-X to achieve debridement during the full 85 days of the study was nine days, while patients treated with SAMHSA didn't achieve the median time to complete debridement.
Barry: The results of the head to head analysis are compelling and were achieved with robust statistical significance.
Barry: Starting with the incidence of complete debridement, 63% of patients achieved complete debridement within two weeks with Eschar X versus zero percent, what Samsung Importantly, the estimated median time it took for eschar X to achieve debridement. During the full 85 days of the study was nine days, while patients treated with Chantal.
Barry: Didn't achieve the median time to complete debridement.
Barry J. Wolfenson: Looking at wound bed preparation, which includes both complete debridement and also having the wound bed completely covered with granulation tissue, a critical step in wound healing, 78.3 percent of patients treated with SRX achieved it during the study versus only 37.5 percent of patients treated with Santil. Once again, it was very quick with SRX, where the median time to achieve it was only 11 days versus no achievement of a median time with Santil. While the incidence of wound closure was favorable to SRX but not statistically significant in this small sample size, the average time to complete wound closure was only 48.4 days for SRX versus 76 days for Santil, a full month differential which reached significance with a p-value of 0.8. 0.05 The safety profile was comparable between the two.
Barry: Looking at wound bed preparation, which includes both complete debridement and also having the wound bed completely covered with granulation tissue a critical step in wound healing 78, 3% of patients treated with <unk> achieved at during the study versus only 37, 5% of patients treated with Santo <unk> once again.
Barry: It was very quick with Eschar X, where the median time to achieve it was only 11 days versus no achievement of a median time, which sample.
Barry: While the incidence of wound closure was favorable to ask Rx, but not statistically significant in this small sample size. The average time to complete wound closure with only 48 four days for S. Correct versus 76 days for sample a full month differential.
Which reached significance with a P value of point.
Barry: <unk> the same.
Barry: Safety profile was comparable between the two.
Barry J. Wolfenson: We look forward to sharing this data at three leading Congresses in the field that are taking place in May this year, the Wound Healing Society, the Symposium on Advanced Wound Care, and the European Wound Management Association. Thanks to the promising results of phase two, we have garnered much interest from leading companies in the wound healing space and have established research collaborations to support the SRX phase three study with 3M, Monlica, and MiMedx. These three companies represent the top offerings in the product categories integral to venous leg ulcer care, compression therapy, advanced wound dressings, and cell-based products. SRX is a potential blockbuster, and the company is focused and committed to the successful execution of the clinical development program and to diligently performing all the pre-commercial activities required to ensure an optimal launch. With that, Ofer, back to you.
Speaker Change: We look forward to sharing this data at three leading congresses in the field that are taking place in may this year. The wound healing society. The symposium on advanced wound care and the European wound Management Association. Thanks.
Speaker Change: Thanks to the phase two promising results, we have garnered much interest from leading companies in the wound healing space and have established research collaborations to support the <unk> phase III study with three M. Monica and my medics. These three companies represent the top offerings in the product categories integral to venous leg ulcer care.
Speaker Change: Compression therapy advanced wound dressings and cell based products.
Speaker Change: That's correct as a potential blockbuster and the company is focused and committed to the successful execution of the clinical development program and to diligently performing all of the pre commercial activities required to ensure an optimal launch with that back to you.
Yeah.
Ofer Gonen: Thank you, Barry. So to summarize, Mediwound has made outstanding progress in 2023. NexoBreeze has been launched in three major markets. Its indication has been expanded to include the pediatric population in Europe, with further potential for pediatric use in the United States later this year. There has been continued commitment to grant funding from the U.S. government. All of these have driven increased global demand, which we are on track to meet with the scale-up of our manufacturing facility. Our promising drug candidate, Escarex, is gaining recognition for its potential to revolutionize chronic wound care with validation from leading global wound care entities.
Speaker Change: Thank you Barry so to summarize maybe one that's made.
Speaker Change: Outstanding progress in 2023, Nexobrid will launch in three major markets. Its indication has been expanded to include the pediatric population in Europe with further potential of pediatric use in the United States later this year.
Speaker Change: There has been continued commitment in grant funding from the U S. Government. All of these have driven and increased global demand, which we are on track to meet with the scale up of our manufacturing facility.
Oh, a promising drug candidate S. Correct is gaining recognition for its potential in revolutionizing chronic wound care with validation from leading global wound care entities we.
Hani Luxenburg: We are eagerly anticipating the commencement of the Phase 3 study in the second half of 2024. I'll now hand it over to Hani to briefly review our finances.
Speaker Change: We are eagerly anticipating the commencing over the phase III study in the second half of 2024.
Speaker Change: I'll now hand, it over to Jaime to briefly review our financial Honey.
Hani Luxenburg: Thank you, Ofer. Let me begin with our revenue for the first quarter. In the first quarter of 2023, the company reported revenue of $5.3 million, a decrease from $11.6 million in the first quarter of 2022. This decrease is mainly due to the BLA Approval Milestone Payment from Verisel received in the previous year. Gross profit for the quarter was $0.7 million, or 13.5% of total revenue, compared to $8.2 million, or 70.2% of total revenue, in the first quarter of 2022. The decrease in gross profit is largely attributed to the BLA approval milestone payment from Verisel in prior years.
Jaime: Thank you all fir.
Jaime: Let me begin with our revenue for the first quarter.
Jaime: In the first quartile for 2023, the company reported revenue of $5 $3 million.
Jaime: It decreased from $11 6 million in the first quarter of 2022.
Jaime: This decrease is mainly due to the BLA approval milestone payment for the resell it seemed in the previous year.
Jaime: Golf ball faithful, but there was 0.7 million or 13.5% of total revenue compared to the $8 2 million or 72% of total revenue in the first quarter of 2022.
Jaime: The decrease in golf Ball says Paul fate is largely attributed to the BLA approval milestone payments for various cell in cryo ear.
Jaime: Turning to our operating expenses.
Jaime: The company's research and development expenses amounted to 1.8 million a decrease from $2 7 million in the first quarter of 2022.
Hani Luxenburg: Turning to our operating expenses, the company's research and development expenses amounted to $1.8 million, a decrease from $2.7 million in the first quarter of 2021. This reduction is primarily due to the completion of the S-CORRECT phase two study in 2020. Salary General and Administrative Expenses were reported at 2.8 million, slightly less than the 3 million in the same quarter of the previous year.
Jaime: This one vaccine is playing heavily due to the completion of the escalation phase two study in 2022.
Selling general and administrative expenses were reported at 2.8 million slightly less than the 3 million in the same quarter of the previous year.
Jaime: The operating loss of the quarter was $3 9 million compared to an operating profit of 2.1 million in the first quarter of 2022.
Hani Luxenburg: The operating loss of the quarter was $3.9 million compared to an operating profit of $2.1 million in the first quarter of 2022. The net loss was reported at $1.7 million, or $0.19 per share, which is a decrease from a net loss of $7.5 million, or $1.18 per share, in the first quarter of the previous year. This improvement in net loss is mainly due to a favorable adjustment from the revaluation of warrants. The non-gap adjusted EBITDA for the quarter was a loss of $3.2 million compared to a profit of $3.4 million in the first quarter of 2022. This shift primarily results from the revaluation of the warrants. Now, let's discuss the full year 2023 financial highlights. For the year ended December 31, 2023, the company's revenue totaled $18.7 million, a decrease from $26.5 million for the year ended 2022.
Jaime: The net loss was reported at $1 7 million or 19 cents per share, which is a decrease from a net loss of $7 5 million or one point $18 per share in the first quarter of the previous year.
Jaime: This improvement in net loss is mainly due to the favorable adjustment from the revaluation of warrants.
Jaime: The non-GAAP adjusted EBITDA for the quarter was a loss of $3 2 million compared to a profit of $3 4 million in the first quarter of 2022.
Jaime: This shift primarily result from the revaluation of the warrant.
Speaker Change: Now, let's discuss the full year 2023 financial highlights.
Well. They ended December 31, 2023, the company's revenue totaled $18 7 million a decrease from $26 5 million for the year ended 2022.
Speaker Change: This decrease is once again once again, primarily due to the BLA approval milestone payment from there isn't in the previous year.
Hani Luxenburg: This decrease is once again primarily due to the BLA approval milestone payment from Verizon in the previous year. Gross profit for the year was 3.6 million or 19.1% of total revenue, a decrease from 13.2 million or 49.7% of total revenue in previous years. The decrease in gross profit percentage reflects the absence of the significant one-time payment received in 2020. Research and development expenses for the year were $7.5 million, a decrease from $10.2 million in the previous year. This decrease reflects the completion of our SQRx Phase 2 study in 2022. Selling general and administrative expenses for the year increased slightly to $11.6 million from $10.6 million in previous years.
Speaker Change: Gross profit for the year was $3 6 million or 19.1% of total revenue a decrease from $13 2 million or 49, 7% of total revenue in prior year.
Speaker Change: The decrease in glass ball set percentage reflects the absence of the significant one time payment received in 2022.
Research and development expenses for the year with $7 5 million a decrease from $10 2 million in the previous year.
Speaker Change: This decrease reflects the completion of our escrow next phase two study in 2022.
Speaker Change: Selling general and administrative expenses for the year increased slightly to 11 6 million from $10 6 million in previous year.
Speaker Change: The operating loss for the year.
Speaker Change: $15 3 million compared to an 8.3.
Speaker Change: 3 million loss in previous year.
Speaker Change: The net loss for the year was $6 7 million or 75 cents per share comp.
Speaker Change: Compared to a net loss of $19 6 million or so.
Hani Luxenburg: The Operating Loss for the Ear was... 15.3 million, compared to an 8.3% growth rate and 3 million losses in previous years. The net loss for the year was $6.7 million, or $0.75 per share, compared to a net loss of 19.6 million, or 3.93 per share, for the year ended December 31, 2021. The non-gap adjusted EBITDA showed a loss of 12.3 million compared to a loss of 4.4 million reported in the previous year.
Speaker Change: Three point 93 per share for the year ended December 31 2022.
Speaker Change: The non-GAAP adjusted EBITDA showed a loss of $12 3 million compared to a loss of $4 4 million reported in the previous year.
Speaker Change: Regarding our balance sheet as of December 31, 2020 to be the company's cash restricted cash and investments stood at $42 1 million an increase from 74.1 million reported in the end of 2022.
Speaker Change: In the first quarter of 2023, the company successfully raised 27.5 million through a public offering.
Hani Luxenburg: Regarding our balance sheet, as of December 31, 2023, the company's cash, restricted cash, and investments stood at $42.1 million, an increase from $34.1 million reported at the end of 2020. In the first quarter of 2023, the company successfully raised $27.5 million through a public offering. Throughout the year, the company utilized $70.1 million to fund its activities.
Speaker Change: Throughout the year the company utilized 70.1 million to fund its activity.
Speaker Change: With the current financial standing we believe the company's cash reserve are sufficient to support operations through profitability.
Speaker Change: With that I've concluded the financial review and will turn the call back to O film all Sir.
O: Thank you Jaime.
O: To conclude the company achieved significant milestones in the past quarter and in 2023 overall and we are confident about 2024 and our future.
Hani Luxenburg: With the current financial standing, we believe the company's cash reserves are sufficient to support operations through profitability. With that, I have concluded the financial review and will turn the call back to Ofer.
O: Future growth.
O: Continue to prioritize increasing our manufacturing capabilities to fulfill both current and future orders and meet the rising demand for nexobrid and thereby grow our revenue by greater than 40%.
Ofer Gonen: Thank you, Hani. To conclude, the company achieved significant milestones in the past quarter and in 2023 overall, and we are confident about 2024 and our future growth. We continue to prioritize increasing our manufacturing capabilities to fulfill both current and future orders and meet the rising demand for NexoBrid and thereby grow our revenue by greater than 40%. Escarex has demonstrated superior results over the dominant product in this over $2 billion potential market.
O: That's correct has demonstrated superior results over the dominant product in this over 2 billion dollar potential market.
O: As we look forward to initiating the phase III trial in the second half of 'twenty 'twenty. Four we are delighted to have three research collaborations with a top wound care companies supporting us with this study.
I'm excited about what the future holds for us as we stay committed to redefining the standard of care with Nexobrid and S. Correct.
Speaker Change: Now I would like to open the call for your questions operator.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys if at any time. Your question has been addressed.
Operator: As we look forward to initiating the Phase III trial in the second half of 2024, we are delighted to have three research collaborations with the top wound care companies supporting us with this study. I'm excited about what the future holds for us as we stay committed to redefining the standard of care with Nexovrid and S-Correct. Now I would like to open the call for your questions. Operator. We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys.
Speaker Change: And you would like to withdraw your question. Please press Star then two.
Speaker Change: Again it is star then one to ask a question.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Speaker Change: The first question comes from Josh Jennings with TD Cohen.
Joshua Thomas Jennings: Please go ahead.
Joshua Thomas Jennings: Thanks, and good morning, congratulations on all the progress and.
Joshua Thomas Jennings: The increased demand for <unk>.
Joshua Thomas Jennings: Oh I was just hoping to just two part question on extra bit first but just seems like the demand is surging globally U S partner, but also not to multiple international markets capacity constraints are kind of are limiting but any way to quantify the increased demand that youre seeing youre in 24 hours.
Joshua Thomas Jennings: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. Again, it is better to ask a question than one. At this time, we will pause momentarily to assemble our roster. Our first question comes from Josh Jennings with TD Collins.
Ofer Gonen: Please go ahead. Thanks, and good morning. Congratulations on all the progress, the increased demand for Nexaprint. Ofer, I was just hoping to ask you a two-part question on Nexaprint first, but it just seems like the demand is surging globally, and the U.S. partners with it also in multiple international markets. Capacity constraints are kind of limiting, but is there any way to quantify the increased demand that you're seeing here in 2024 versus 2023, and we're assuming that the 24 million revenue guide would be high without capacity constraints and somewhere in between 24 and 39 million for 2026, that target, but any way to just give some incremental details or quantification of the increased demand for Nexaprint currently?
Joshua Thomas Jennings: It is 2023, and we're assuming that the $24 million revenue guide would would be high without capacity constraints and somewhere in between 24, and a 39 9 million for 2026 at that target, but any way to just give us some incremental details or quantification of the increased demand for an extra rate currently.
Joshua Thomas Jennings: Okay.
Speaker Change: Thank you George for your question to address that I will I will I will just repeat that currently we have a three fold.
Speaker Change: Fall demand.
And more than we can actually manufacture.
Speaker Change: In the first week of 2024.
Already got binding orders.
Speaker Change: That are that are actually filled the capacity that we have in 2024.
Speaker Change: Ming that this demand continues as planned we see the 40% growth is something that is a very conservative and our expectations and guidance is is is only limited by our ability to manufacture so as long as we repeat our guidance.
Ofer Gonen: And thank you, Josh, for your question. To address that, I will, I will, I will just repeat that currently, we have three times the volume, full demand, and more than we can actually manufacture. In the first week of 2024, we already got binding orders that actually filled the capacity that we have in 2024. Assuming that this demand continues as planned, we see the 40% growth as something that is very conservative, and our expectations and guidance are only limited by our ability to manufacture. So as long as we repeat our guidance by completing the construction of the facility in 2024 and having it in full scale sometime in 2025, we can meet those demands accordingly, and I hope I have answered your question. Yes, thanks for reviewing that.
Speaker Change: By completing the construction of the facility in 2024, and having getting full state scale sometime in 2025, we can meet those demands.
Speaker Change: Accordingly, I hope I answered your question.
Speaker Change: Yes, thanks for reviewing that and just one follow up on S correction.
Speaker Change: Maybe just help us think about the final steps here are.
Speaker Change: Is that are required before getting full sign off on.
Uh huh.
Speaker Change: The phase III study and and then also just on the manufacturing side for S corrections or any.
Speaker Change: Where are you there in terms of being able to deliver product for the.
Speaker Change: The full study as it kicks off in the second half.
Speaker Change: Thanks, a lot for taking the questions.
Speaker Change: Yeah.
Ofer Gonen: And just one follow-up on S-Correct. Maybe just help us think about the final steps here that are required before getting full sign-off on the Phase 3 study, and then also just on the manufacturing side for Esker-X. Are there any... Where are you in terms of being able to deliver a product for the full study as it kicks off in the second half? Thanks a lot for taking the questions. So that's a very good question.
Speaker Change: Hum.
Speaker Change: That's a very good question. So the reason are the reason with the stock the day, we started the trial.
Speaker Change: The second half of 'twenty 'twenty four is.
Speaker Change: Generally due to the fact that we focused on manufacturing and Nexobrid in order to be able to meet the demands that we have from our United States, Japan, Europe, India et cetera. The last thing that we need to do before initiating the trial is making sure that we are manufacturing enough batches of S. Correct.
Ofer Gonen: So the reason that we start the trial in the second half of 2024 is primarily due to the fact that we focused on manufacturing an exo-breed and in order to be able to meet the demands that we have from the United States, Japan, Europe, India, et cetera. The last thing that we need to do before initiating the trial is make sure that we are manufacturing enough batches of S-Corrects. Actually, we are doing it as we speak.
Speaker Change: Actually we are doing it are as we speak.
Speaker Change: And then we need to wait 30 days for stability.
Speaker Change: Submit the protocols that are already aligned with both the FDA and EMA and then we can start recruiting patients.
Speaker Change: So this is that the the so for the clinical manufacturing, we don't see any problems. We are now getting ready for the commercial piece.
Ofer Gonen: And then we need to wait 30 days for stability, submit the protocols that are already aligned with both the FDA and EMA, and then we can start recruiting patients. So for clinical manufacturing, we don't see any problems. We are now getting ready for the commercial piece.
We don't want to be in a position that's what S. Correct is approved.
Speaker Change: We are in the same situation as we are in Mexico, but we want to be able to launch successfully S. Correct.
Speaker Change: I think a multi hundreds of millions of dollars of demand in the first one or two years of the launch.
Ofer Gonen: We don't want to be in a position that once S-Corex is approved, we are in the same situation as we are in Nexobrid. We want to be able to successfully launch S-Corex, supporting multi-hundreds of millions of dollars of demand in the first one or two years of the launch. Okay. Thanks so much. The next question comes from Francois Brisebois with Oppenheimer.
Speaker Change: Understood. Thanks, so much.
Speaker Change: Yeah.
Speaker Change: The next question comes from Francois <unk> with Oppenheimer. Please go ahead.
Francois: Thanks for the question just in terms of the design can you remind us on Eschar X. If it's you know based on the timing of the start of the trial here in the second half.
Francois: Can you remind us maybe the timing and when it would be realistic for us to expect the interim readout.
Franois Daniel Brisebois: Please go ahead. Thanks for the question. Just in terms of the design, can you remind us about SCAR-X, if it's, you know, based on the timing of the start of the trial here in the second half, can you remind us maybe of the timing and when it'd be realistic for us to expect the interim readout? So, thank you for the question, Francois. So, the trial, we need to recruit 216 patients that will be randomized one-to-one to S-Corrects versus placebo. After 67% of the recruitment and after those participants have completed the trial, we have an interim assessment. I would expect that something like 18 months after the study initiation.
Francois:
Speaker Change: So thank you for the question Francois.
Francois: So the trial.
Speaker Change: We need to recruit 200 within 16 patients that will be randomized one to one S correct versus placebo after 67% of the recruitment and after those participants have completed the trial, we have an interim assessment I would expect that to something like 18 months. After the study.
Francois: Initiate.
Speaker Change: Okay, great. Thank you and then in terms of the.
Speaker Change: You talked about various though in the centers a little bit of a metrics there.
Speaker Change: 50 centers 25, just the numbers can you maybe help us understand how many centers total are there for verso and where do we stand.
Speaker Change: So.
Speaker Change: Again very sell is responsible for the U S market, so it's better to ask them that.
Ofer Gonen: Okay, great. Thank you. And then, in terms of the, you talked about Veracel and the centers, a little bit of metrics there. 50 centers, 25, just the numbers.
Speaker Change: That's question, but what I can share with you that they're around one.
Speaker Change: 100 centers.
Speaker Change: That treats a patient for adults and once we.
Speaker Change: We get the approval of the pediatric population there would be additional 30 centers that will be relevant so all in all in the United States at around 130 centers that he said already reported that by the end of last.
Ofer Gonen: Can you maybe help us understand how many centers there are for Veracel and where we stand? So... Again, VeriCell is responsible for the U.S. market, so it's better to ask them that question. But what I can share with you is that there are around 100 centers that treat burn patients for adults. And once we get the approval of the podiatric population, there will be an additional 30 centers that will be relevant. So all in all, in the United States, there are around 130 centers.
Speaker Change: Last year.
Speaker Change: They were approached already 50, they got 50 committee.
Speaker Change: Engagement 25 of them already approved so I think that we have the they're doing a very good job with that.
Speaker Change: Okay, and just lastly quickly in terms of the shelf life, you talked about exploration and obviously demand.
Speaker Change: Can change depending on the exploration how long does it take for your product to expire.
Speaker Change: The problem that the shelf life of Mexico, where it currently is almost three years at student at two years and nine months.
Ofer Gonen: Very few have already reported that by the end of last year, they were approached already 50 times, they got 50 committee engagement, and 25 of them were already approved. So I think that we have, and they're doing a very good job with that. Okay, and lastly, quickly, in terms of shelf life, you talked about expiration, and obviously, demand can change depending on expiration. How long does it take for your product to expire? The shelf life of NexoBrid currently is almost 3 years; it's 2 years and 9 months. But as you can imagine, due to the fact that the demand for commercial, I'm not speaking about even stockpiling, for commercial use, is such a significant, we don't expect any expiration of NexoBraid.
Speaker Change: But as you can imagine imagine and due to the fact that the demand for commercial I'm not speaking about the about the even stockpiling for commercial use.
Speaker Change: <unk> is a such a significant and we don't expect any exploration of Nexobrid product everything is going to be use everything that we shipped every every vial of nexobrid that are shipped to a customer is being used in the in the following few months.
Speaker Change: Operations at this stage at this stage is not something that bothers us.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: The next question comes from RK with H C. Wainwright. Please go ahead.
Ofer Gonen: Everything is going to be used, everything that we ship, every vial of NexoBraid that is shipped to a customer is going to be used in the following few months. So expiration, at this stage, is not something that bothers us. Thank you. The next question comes from R.K. with H.C. Wainwright.
RK: Thank you.
RK: Good morning, Oh for them Honey.
RK: Hum.
RK: I'm, sorry, and then I also have a question on capacity.
RK: Capacity in Mexico brand.
RK:
RK: Just trying to think through some of the projections, you've put out there or 'twenty five and 'twenty six.
R.K.: Please go ahead. Thank you. Thanks. Good morning, Ofer and Hani. I'm sorry; I also have a question on the capacity and mix of bread.
RK: So.
RK: Going to the far end in 2006.
RK: And you can see our.
RK: Projection of $39 million.
Ofer Gonen: Just trying to think through some of the projections you put out there for 25 and 26. [inaudible] Going to the far end in 2026 and with your projection of $39 million. What are you taking into consideration there? Are you taking... Thank you. Thank you, that you will be able to handle all the demand that is out there at this point, or you're also including the projected growth from all these territories, whether it is the U.S., Japan, India, pediatric approval, and governments. Hi RK.
RK: What are you taking.
RK: Into consideration there are you taking.
RK:
RK: That you wouldn't be you wouldn't be able.
RK: To handle all the demand that is out there at this point.
RK: Hum.
RK: You are also including the projected.
RK: From all of these territories, whether it is the U S, Japan and India.
RK: Do you have to get approval on the governments.
Speaker Change: Hi, Okay.
Ofer Gonen: Well, it's a good question. We took things conservatively when we looked at the 39; we didn't plan on a very significant growth of demand. We are looking at current demand. We are looking at the performance of specific markets that we are already in. For instance, in Japan, their expectation was that we could increase quite substantially our shipments to them after one quarter of being in the market. So the product was accepted there extremely well. So as for 2026, the 39 million, we do not include all kinds of growth and unexpected positive surprises.
Speaker Change: Well, it's a good question, we we took care of conservatively when we looked at the 39, we didn't plan on a very significant growth of demand. We're looking at the current demand.
Speaker Change: We're looking at the performance on specific markets that we're already in for instance in Japan.
Speaker Change: The the their expectation was that we can increase quite substantially our our shipments to them.
Speaker Change: After one quarter.
Speaker Change: Of being in the market. So the product was accepted their assembly well so I for 20 of $26 million to $39 million. We do not include all kind of a growth an unexpected positive surprises is only based on our ability to know that in 2026, we can meet all.
Ofer Gonen: It's only based on our ability to know that in 2026, we can meet all the demand that we currently have. Now, if we have any surprises, this specific facility will be able to support more than $80 million in revenue. So we are okay with a scenario of unexpected growth. And then, in terms of on the SCorec side, Barry was saying there's going to be data presented at three different conferences in May. I just want to understand, you know, if there will be any updates at these conferences that can help us kind of understand, figure out how, what to expect in the pivotal study, in the 216 patient study, which we probably will see some data on, as I said, 18 months from the start of the program, it's probably more than 26, I would think. Let me elaborate a little bit on that.
Speaker Change: The demand that we currently have now if we have surprises. This specific facility, we'll be able to support more than $80 million in revenue. So we are okay with it with familiar of unexpected growth.
Speaker Change: Hum.
Speaker Change: And then in terms of.
Speaker Change: On the aesthetics side.
Speaker Change: Body was saying.
Speaker Change: Data presented in two different conferences, it's been me.
Speaker Change: I just wanted to understand.
If there will be any.
Speaker Change: Any updates in these in these conferences, which can help us kind of an.
Speaker Change: Thinking about how what to expect.
Speaker Change: In the pivotal study.
16 patient study.
Speaker Change: Which we probably will see some data I just said.
Speaker Change: 18 months from the start of.
Speaker Change: Okay.
Speaker Change: Probably it's more like 26, I would think right.
Speaker Change:
Let me elaborate a little bit on that so as you can all figured out the strength of these data offer scholarships versus ER.
Ofer Gonen: So, as you can all figure out the strength of this data escrow versus Santil. They were extremely robust. They positioned Escarex to become the market leader in enzymatic agents for the treatment of chronic wounds. There is a lot of interest in the industry around this specific data that we have, but the FDA, I want to remind you all, the FDA is focused on the performance of Escarex versus placebo. So we will issue additional data, and there is a lot of strategic interest in what we are going to present at the Wound Healing Society, at the Symposium of Advanced Wound Care, and at the European Wound Management Association. But it will not give you more color regarding our probability of succeeding in our phase three trial, which is supposed to be easier because it is versus placebo. Thanks for taking all my questions. The next question comes from Michael Okunewitch with Maxim Group.
Speaker Change: <unk> were extremely robust they position and S corrects to become the market leader in enzymatic agents for the treatment of chronic wounds.
Speaker Change: There is a lot of interest in the industry, allowing these specific data that we have.
Speaker Change: But the F D. A I want to remind you all the FTA is focused on the performance of our Oh S correct versus placebo.
Speaker Change: So we will issue additional data and there is a lot of strategic interest about what we are going to present the wound healing society at the symposium of advanced wound care and at the European one.
Speaker Change: Management Association.
Speaker Change: But it will not give you more color.
Speaker Change: Regarding our.
Speaker Change: The probability of succeeding in our phase III trial, which is supposed to be easier because it is versus the stable.
Speaker Change: Thanks, Thanks for taking all my questions. Thank you Akshay.
Speaker Change: The next question comes from Michael.
Michael: <unk> <unk> with Maxim group.
Michael Okunewitch: Please go ahead. All right. Thank you very much for taking my questions today. Congratulations on all the progress. So, I guess the first thing I wanted to ask is just with the acceptance of the pediatric SPLA, is there a similar thesis here for pediatric patients in the U.S. as you had with Europe where you could see outsized utilization due to the nature of the pediatric burns market, or is that a unique feature of the European market? I hope to understand you correctly.
Michael: Please go ahead.
Michael: Alright, Thank you very much for taking my questions today and congratulations on all the progress.
Michael:
Michael: Yeah.
Speaker Change: I guess the first thing I wanted to ask is just with the.
Speaker Change: Acceptance in the pediatric S. B L. A is there a similar thesis here for pediatric patients in the U S. As you had with Europe, where you could see.
Speaker Change: Outsized utilization.
Speaker Change: The nature of the pediatric burns market or is that a unique feature of the European market.
Speaker Change: I hope you understand it correctly, we we got a we see if the European Commission approval and broaden the Nexobrid label in and in Europe.
Ofer Gonen: We received European Commission approval and brought in the next label in Europe last quarter, and now it is for all ages. It will not impact our immediate financial outcome because of the limitation of our capacity. So maybe the proportion between the treatments for adults and pediatrics will change a little bit, but it won't impact our bottom line. In the United States, we expect the same.
Speaker Change: Last quarter and now with is it is it is it is for all ages.
Speaker Change: It will not impact our immediately immediate the financial outcome because of the limitation of our capacity. So maybe the proportion between the treatment of adult and.
Speaker Change: Pediatric will change a little bit, but it won't impact our bottom line and the United States. We expect the same we had a very robust phase III study with pediatric patients. We believe that a the U S. The FDA will not have different requirements than that.
Ofer Gonen: We had a very robust phase 3 study with pediatric patients. We believe that the FDA will not have different requirements than the Europeans. So, as we guided, we expect to get this approval later this year. Again, the impact on future revenue is quite extensive because the proportion of the pediatric population in the United States is approximately 30 to 40% of the overall population. Therefore, this label extension should significantly increase the addressable market. I was asking more in terms of a greater degree of utilization because Nexabrit is more gentle and provides less scarring, as you said, in the European population, not in terms of immediate rubbing. I believe that if you look at how the standard of care in the United States was until a quarter ago, it is even painful to watch, very aggressive, a lot of pain and blood associated. We believe that we have an ideal partner in the United States to take over this market quite swiftly, and it will also be adopted the same in Europe. Children are; I don't see a parent prefer that his child will go through a painful operation instead of being applied a topical drug.
Speaker Change: Your pin pad so as we guided we expect to get this approval later this year again the impact on future revenue is quite extensive because the number the the propulsion of pediatric formulation in the United States is approximately 30% to 40%.
Speaker Change: The overall population therefore.
Speaker Change: This label extension should significantly increase the addressable market.
Speaker Change: I was asking more in terms of.
Speaker Change: The greater degree of utilization because nexobrid is more gentle and provides less scarring as he said with the European population not in terms of immediate revenue.
Speaker Change: I believe that Oh, if if you look at the how the standard of care in the United States.
Speaker Change: Until a quarter ago. It is even painful to watch very aggressive a lot of pain in blood.
Speaker Change: And associated.
Speaker Change: We believe that our we have an ideal partner in the United States to take over this market quite swiftly.
Speaker Change: And it will be also adopted the same in Europe.
Speaker Change: Children are I don't see our parents.
Speaker Change: But for the child will go through and painful operation instead of being applied with a topical drug.
Ofer Gonen: All right, thank you for that. And then I also wanted to see if you could give me any additional color on the timeline you're expecting for the DOD stabilized formulation. And then would this be limited to DOD sales in the program? Or could this be applicable to foreign governments or first responders in more result regions or NGOs?
Speaker Change: Alright. Thank you for that and then I also wanted to see if you could give me.
Speaker Change: Any additional color on the timeline youre expecting for the Dod stabilized formulation and then would this be limited to Dod sales on the program or could this be applicable to foreign governments are first responders and more result regions are Ngls and there are other organizations that might all.
Ofer Gonen: Are there other organizations that might also seek to utilize a temperature stabilized formulation? So Michael, this is a very good question. As I mentioned, we got $13 million in R&D funding from the DoD to advance this project. We believe it can open the gate for us with additional armies, as well as simplify our supply chain costs and administration, moving from cool chain to room temperature. So the project is well underway, we have all kinds of very successful or encouraging results, and we are hoping to see the U.S. Army embracing the fruits of our collaborations in the next few years. We plan to have a meeting with the FDA next quarter to discuss the development path and to get some guidance on what is required in order to approve this product. I should also mention here that this product is, of course, under the license agreement with Verisales, so any involvement or any commercial activity in the United States is, of course, subject to agreement with them.
Speaker Change: Also seek to utilize a temperature stabilized formulation.
Speaker Change:
Speaker Change: So this is a very good question. So as I mentioned, we got the $10 million R&D funding from the D O D to advance this.
Speaker Change: The project, we believe it can open the gates for us for additional armies as well as simplify our supply chain cost and administration moving from cold chain to room temperature.
Speaker Change: So the project is well underway, we have all kinds of very successful.
Speaker Change: Successful or encouraging results and we are hoping to see the U S Army embracing the fruits of our collateral collaborations in the next few years, we plan to have a meeting with the F D. A.
Speaker Change: Next quarter to discuss the development path and to get some guidance of what is required.
Speaker Change: In order to approve this product.
Speaker Change:
Speaker Change: I can only I should also mention here that this product is of course under the license agreement with various sales so any any.
Speaker Change: Any.
<unk>, Oh, Oh, any commercial activity in the United States of course, it's subject to agreement with them.
Michael Okunewitch: All right. Thank you very much. And once again, congratulations on all the progress you've made. At this time, these are all the questions we will be taking today.
Speaker Change: Alright, Thank you very much and once again congrats on all the progress you've made.
Speaker Change: Thank you Micah.
Speaker Change: Yeah.
Speaker Change: At this time. These are all the questions we will be taking today I would like to now turn the conference back over to management for closing remarks.
Operator: I would like to now turn the conference back over to management for closing remarks. Thank you everyone for joining us today. We look forward to updating you again on our next call. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect, and many more. I'm your host, Swayampakula Ramakanth.
Speaker Change: Thank you ever mindful joining us today, we look forward to updating you again on our next call.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].