Mediwound Ltd (MDWD) 2022 Q4 法說會逐字稿

Good day, and welcome to MediWound's Fourth Quarter and Year-End 2022 Earnings Call. Today's conference is being recorded.

美好的一天，歡迎來到 MediWound 的 2022 年第四季度和年終收益電話會議。今天的會議正在錄製中。

At this time, I would like to turn the conference over to Monique Kosse of LifeSci Advisors. Monique, please go ahead.

此時，我想將會議轉交給 LifeSci Advisors 的 Monique Kosse。莫尼克，請繼續。

Thank you, operator, and welcome, everyone.

謝謝接線員，歡迎大家。

Earlier today, MediWound issued a press release announcing financial results for the fourth quarter and year ended December 31, 2022. You may access that release on the company's website under the Investors tab. With us today are Ofer Gonen, Chief Executive Officer of MediWound; and Boaz Gur-Lavie, Chief Financial Officer. Following our prepared remarks, we will open the call for Q&A.

今天早些時候， MediWound 發布了一份新聞稿，宣布了截至2022年12月31日的第四季度和年度的財務業績。您可以在公司網站的“投資者”選項卡下訪問該新聞稿。今天和我們在一起的有 MediWound 的首席執行官 Ofer Gonen；首席財務官 Boaz Gur-Lavie。在我們準備好的評論之後，我們將開啟問答環節。

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. Although the company believes 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 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. Participants are directed to cautionary notes set forth in today's press release as well as the 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.

在我們開始之前，我想提醒大家，在本次電話會議期間，包括問答環節，與 MediWound 的預期未來業績、未來業務前景或未來事件或計劃相關的陳述是私人證券訴訟改革所定義的前瞻性陳述1995 年法案。雖然公司認為此類前瞻性陳述中反映的預期是基於合理的假設，但實際結果和結果受風險和不確定性的影響，並且由於許多無法控制的因素的影響，可能與預測存在重大差異MediWound 的。公司不承擔更新或補充任何前瞻性陳述的義務，無論是由於新信息、未來事件或其他原因。參與者應注意今天新聞稿中提出的警示性說明以及 MediWound 向美國證券交易委員會提交的年度報告中提出的風險因素，這些因素可能導致實際結果與前瞻性陳述中預期的結果存在重大差異。

The conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound.

電話會議是 MediWound 的財產，未經 MediWound 書面同意，明確禁止任何錄音或轉播。

Now I'd like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer?

現在我想把電話轉給 MediWound 的首席執行官 Ofer Gonen。報價？

Thank you, Monique, and good morning, everyone. It is my pleasure to welcome you to our conference call.

謝謝你，Monique，大家早上好。很高興歡迎您參加我們的電話會議。

I'm excited to be here today to discuss the remarkable company achievements in the fourth quarter and throughout 2022. We have made important achievements in all of our programs, positioning ourselves to become a global biopharmaceutical company. During my 8 months tenure as CEO, our progress has been significant, including the FDA approval of NexoBrid, which is now ready for a commercial launch in the United States with our partner, Vericel. This innovative therapy has the potential to transform treatment of severe burns and become the standard of care in the United States as it is already in Europe. Additionally, we are moving EscharEx into Phase III study in venous leg ulcers, demonstrating our commitment to advancing treatment for patients in need.

我很高興今天能來到這裡，討論公司在第四季度和整個 2022 年取得的非凡成就。我們在所有項目中都取得了重要成就，將自己定位為一家全球生物製藥公司。在我擔任 CEO 的 8 個月任期內，我們取得了重大進展，包括 FDA 批准 NexoBrid，現在已準備好與我們的合作夥伴 Vericel 在美國進行商業發布。這種創新療法有可能改變嚴重燒傷的治療方法，並成為美國的護理標準，就像它已經在歐洲一樣。此外，我們正在將 EscharEx 轉移到下肢靜脈潰瘍的 III 期研究中，表明我們致力於為有需要的患者推進治療。

Our success is due in part to our strong financial position, fueled by fundraising efforts that have brought in $70 million over the past year from top quality institutional investors. Looking ahead, we are well positioned to take advantage of what we believe will be another excellent year. Our team is fully dedicated to realizing the mission of improving patient outcomes and bringing innovative therapies to the global health care market.

我們的成功部分歸功於我們強大的財務狀況，這得益於我們在過去一年中從頂級機構投資者那裡籌集了 7000 萬美元的籌款活動。展望未來，我們已做好充分準備，充分利用我們認為又會是出色的一年。我們的團隊完全致力於實現改善患者治療效果並為全球醫療保健市場帶來創新療法的使命。

Now let me discuss NexoBrid in more detail. We were proud to see NexoBrid approved by the FDA in December. This achievement is a testament to the hard work and dedication of our team who left no stone unturned in developing the science, conducting the trials, analyzing the data, completing the BLA and of course, putting manufacturing protocols in place. We are confident that NexoBrid has the potential to change the standard of care for burn patients in the United States and around the world, and we are proud to be at the forefront of this revolution. We also know that the data and the rigorous review that supported NexoBrid's approval validates our technology platform and will support the regulatory pathway for our pipeline of products.

現在讓我更詳細地討論 NexoBrid。我們很自豪地看到 NexoBrid 在 12 月獲得了 FDA 的批准。這一成就證明了我們團隊的辛勤工作和奉獻精神，他們不遺餘力地發展科學、進行試驗、分析數據、完成 BLA，當然還有製定製造協議。我們相信 NexoBrid 有可能改變美國和世界各地燒傷患者的護理標準，我們為站在這場革命的前沿而自豪。我們還知道，支持 NexoBrid 獲得批准的數據和嚴格審查驗證了我們的技術平台，並將支持我們產品管道的監管途徑。

We look forward to partnering with Vericel for the U.S. commercial launch of NexoBrid, which has a market potential of $300 million. Vericel is actively preparing for the launch in the second quarter with their sales teams, medical training and educational sessions, and we have seen widespread interest and enthusiasm for NexoBrid on burn centers and other health care professionals. We are confident in Vericel's ability to successfully launch NexoBrid and provide access to burn patients in the United States.

我們期待與 Vericel 合作，在美國商業推出 NexoBrid，該產品具有 3 億美元的市場潛力。 Vericel 正在積極準備第二季度的銷售團隊、醫療培訓和教育課程，我們已經看到燒傷中心和其他醫療保健專業人員對 NexoBrid 的廣泛興趣和熱情。我們相信 Vericel 有能力成功推出 NexoBrid 並為美國的燒傷患者提供服務。

Our ongoing NexoBrid expanded access program has allowed physicians at leading burn centers in the United States to gain important first-hand experience using NexoBrid. We have successfully treated 206 patients at 26 leading burn centers in the United States. And based on their feedback, we are confident that NexoBrid will be an important part of the standard of care practice. We are also pleased to collaborate with the U.S. Department of Defense for the development of NexoBrid as a nonsurgical solution for the treatment of burns in the field, and we look forward to continue promoting this project and will provide additional updates this year.

我們正在進行的 NexoBrid 擴展訪問計劃使美國領先燒傷中心的醫生能夠獲得使用 NexoBrid 的重要第一手經驗。我們已在美國 26 個領先的燒傷中心成功治療了 206 名患者。根據他們的反饋，我們相信 NexoBrid 將成為護理實踐標準的重要組成部分。我們也很高興與美國國防部合作開發 NexoBrid 作為現場治療燒傷的非手術解決方案，我們期待繼續推動該項目並將在今年提供更多更新。

Globally, NexoBrid gained marketing approvals in Japan, India and Switzerland, and we anticipate commercial launches in these large markets later this year. We also anticipate an approval of the pediatric label expansion in Europe by mid-2023, which will further broaden the market and accelerate NexoBrid's revenue growth worldwide. NexoBrid generated $26.5 million in revenue last year, and it will be cash flow positive this year. We expect revenue growth to exceed 50% in 2023 due to the product launches, the global demand and the pediatric label extension in Europe. To meet the growing demand, we are expanding our manufacturing capabilities by scaling up our facility and adding an additional manufacturing line. We are on track to complete this process.

在全球範圍內，NexoBrid 在日本、印度和瑞士獲得了上市許可，我們預計今年晚些時候將在這些大型市場推出商業產品。我們還預計，到 2023 年年中，歐洲兒科標籤的擴展將獲得批准，這將進一步拓寬市場並加速 NexoBrid 的全球收入增長。 NexoBrid 去年創造了 2650 萬美元的收入，今年將實現正現金流。由於產品發布、全球需求和歐洲兒科標籤的擴展，我們預計 2023 年收入增長將超過 50%。為了滿足不斷增長的需求，我們正在通過擴大我們的設施和增加一條額外的生產線來擴大我們的製造能力。我們正在按計劃完成這一過程。

Also, in preparation for our expanding needs, we have made some important additions to our team that includes several talented executives who have experience in building world-class facilities, developing innovative wound class products and executing on commercial operations. This includes Dr. Robert Snyder, our Chief Medical Officer; Tzvi Palash, our Chief Operating Officer; Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development; and Alicia Torrenova, our Vice President of European Operations. These talents will be essential for expanding our global presence, supporting the increased demand of NexoBrid, accelerate our blockbuster opportunity as correct.

此外，為了滿足我們不斷擴大的需求，我們對我們的團隊進行了一些重要的補充，其中包括幾位才華橫溢的高管，他們在建設世界一流的設施、開發創新的傷口類產品和執行商業運營方面擁有豐富的經驗。這包括我們的首席醫療官 Robert Snyder 博士； Tzvi Palash，我們的首席運營官； Barry Wolfenson，我們的戰略和企業發展執行副總裁；和我們的歐洲運營副總裁 Alicia Torrenova。這些人才對於擴大我們的全球影響力、支持 NexoBrid 不斷增長的需求、加速我們的重磅炸彈機會至關重要。

Now let me turn to our progress with EscharEx, our next-generation enzymatic therapy for chronic and hard-to-heal wound. MediWound is focused on realizing this billion-dollar market opportunity. Our Phase II results clearly demonstrated that EscharEx outperformed the nonsurgical standard of care in debridement of venous leg ulcers. With only 8 applications over a 14-day period, the study met the primary endpoint with a high degree of statistical significance. The median time to achieve complete debridement was 9 days in patients treated with EscharEx compared to 59 days in the nonsurgical standard of care arm. On average, 3.6 treatment applications were needed to achieve complete debridement with EscharEx compared to 12.8 applications of the nonsurgical standard of care. Results were highly statistically significant. Additionally, our Phase II pharmacology study showed robust results with an average of 8.9 applications to achieve the debridement. Study also demonstrated a reduction in biofilms and bioburden.

現在讓我談談我們在 EscharEx 方面的進展，EscharEx 是我們用於慢性和難以癒合傷口的下一代酶療法。 MediWound 專注於實現這個價值數十億美元的市場機會。我們的 II 期結果清楚地表明，EscharEx 在下肢靜脈潰瘍清創方面優於非手術護理標準。該研究在 14 天內僅進行了 8 次申請，達到了具有高度統計意義的主要終點。接受 EscharEx 治療的患者達到完全清創的中位時間為 9 天，而非手術標準護理組為 59 天。與非手術標準護理的 12.8 次相比，EscharEx 平均需要 3.6 次治療才能實現完全清創。結果具有高度統計學意義。此外，我們的 II 期藥理學研究顯示出穩健的結果，平均需要 8.9 次應用才能實現清創。研究還表明生物膜和生物負荷減少。

We submitted the protocol design of the Phase III study with the FDA for review. The final trial design will be announced while the discussions with the FDA are completed. We anticipate initiating the study in the second half of 2023. We plan also to submit a request to EMA for the scientific advice on our Phase III protocol and on the clinical development plan of EscharEx. This global approach should not have an impact on our time line. EscharEx has gained the attraction of wound care specialists and many important strategic players in the market. Topical debriding agents with the competitive advantages of EscharEx would be a significant step forward for patients and caregivers. We are thrilled to have the funding to advance this program as quickly as possible and are confident that EscharEx has incredible potential to unlock significant shareholder value.

我們向 FDA 提交了 III 期研究的方案設計以供審查。最終試驗設計將在與 FDA 的討論完成後公佈。我們預計將在 2023 年下半年啟動這項研究。我們還計劃向 EMA 提交一份請求，要求就我們的 III 期方案和 EscharEx 的臨床開發計劃提供科學建議。這種全球方法不應影響我們的時間表。 EscharEx 吸引了傷口護理專家和市場上許多重要的戰略參與者。具有 EscharEx 競爭優勢的局部清創劑將是患者和護理人員向前邁出的重要一步。我們很高興獲得資金以盡快推進該計劃，並相信 EscharEx 具有釋放重要股東價值的不可思議的潛力。

Finally, turning to MW005, where I'm excited to update you on our promising biological drug candidate for treating non-melanoma skin cancers. Q4 2022, we released positive data from our Phase I/II study on low-risk basal cell carcinoma, demonstrating that MW005 is safe and well tolerated. Patients in this study achieved complete clinical and histological clearance of their target lesions. We are currently enrolling additional patients in this specific study to optimize dosing and application and expect results in Q3 2023. It is worth noting that MW005 shares the same active pharmaceutical ingredients as NexoBrid and EscharEx. This platform technology reduces many of the clinical development risks associated with MW005 as it has already been proven to be safe and effective.

最後，轉到 MW005，我很高興向您介紹我們用於治療非黑色素瘤皮膚癌的有前途的候選生物藥物。 2022 年第四季度，我們發布了關於低風險基底細胞癌的 I/II 期研究的積極數據，證明 MW005 是安全且耐受性良好的。本研究中的患者實現了其目標病變的完全臨床和組織學清除。我們目前正在這項特定研究中招募更多患者，以優化劑量和應用，並預計在 2023 年第三季度取得結果。值得注意的是，MW005 與 NexoBrid 和 EscharEx 共享相同的活性藥物成分。該平台技術降低了許多與 MW005 相關的臨床開發風險，因為它已被證明是安全有效的。

In conclusion, we are very well positioned for a strong 2023. There are several promising milestones in the future. NexoBrid is set to launch in the United States in the second quarter of this year. Additionally, we anticipate further key global market launches and are preparing for potential pediatric label expansion in Europe. Before this growth, we are scaling up our manufacturing facilities. Furthermore, we plan to initiate a Phase III study with EscharEx in venous leg ulcers in the second half of 2023 and anticipate additional data for MW005. With a strong balance sheet and nearly $66 million in cash, we are well positioned to support our development and strategic plans through 2026. I'm very optimistic about MediWound's future and believe that we have established a solid foundation for a continued success.

總之，我們為強勁的 2023 年做好了充分準備。未來有幾個充滿希望的里程碑。 NexoBrid 將於今年第二季度在美國上市。此外，我們預計將進一步推出關鍵的全球市場，並正在為歐洲潛在的兒科標籤擴張做準備。在這種增長之前，我們正在擴大我們的製造設施。此外，我們計劃在 2023 年下半年啟動 EscharEx 治療腿部靜脈潰瘍的 III 期研究，並預計 MW005 的更多數據。憑藉強勁的資產負債表和近 6600 萬美元的現金，我們有能力支持我們到 2026 年的發展和戰略計劃。我對 MediWound 的未來非常樂觀，並相信我們已經為持續成功奠定了堅實的基礎。

Before I turn the call over to Boaz for a review of our financials, I want to take a moment to address the news of his departure that was announced today. Boaz has been invaluable asset to the company and has provided strong financial and commercial leadership during his tenure. I'm grateful for his support during my transition to CEO and appreciate all that he has done for us. We decided to welcome Hani Luxenburg as our new Chief Financial Officer, with a proven track record of 20 years delivering business growth and profitability. I'm confident that Hani will help us continue to achieve our goals and drive our success forward. Boaz will remain with the company through July 31 to ensure a smooth and orderly transition. I want to thank him for his dedication and hard work over those years.

在我將電話轉給波阿斯審查我們的財務狀況之前，我想花點時間談談今天宣布的他離職的消息。 Boaz 一直是公司的寶貴資產，在他任職期間提供了強有力的財務和商業領導。我感謝他在我過渡到 CEO 期間給予的支持，感謝他為我們所做的一切。我們決定歡迎哈尼·盧森堡 (Hani Luxenburg) 擔任我們的新首席財務官，她在 20 年的業務增長和盈利方面有著良好的業績記錄。我相信 Hani 將幫助我們繼續實現目標並推動我們取得成功。 Boaz 將在 7 月 31 日之前留在公司，以確保平穩有序的過渡。我要感謝他多年來的奉獻和辛勤工作。

With that said, I'll now hand it over to Boaz for a brief overview of our financials. Boaz?

話雖如此，我現在將其交給波阿斯，簡要概述一下我們的財務狀況。波阿斯？

Good morning, everyone, and thank you, Ofer, for your kind words.

大家早上好，謝謝 Ofer 的美言。

I would also like to express my gratitude to all of you, our investors and analysts for your support and collaboration throughout my time as CFO at MediWound. As Ofer mentioned, I will be stepping down from a role at the end of July. It has been an honor and a pleasure to lead such a talented team of individuals and to spearhead the financial and commercial accomplishments that we have achieved together. I'm proud to have played the key role in driving our growth and success, and I'm confident that the company is in a strong financial position to continue executing in clinical and commercial programs under the new leadership of Ofer as CEO. It was important for me to assist with Ofer transition as CEO at MediWound and to contribute to the recent fundraising round as well as to develop and execute on our European operations and our global expansion strategy. With these efforts, I'm confident that MediWound is well positioned for continued success. Not less, it was fun working together. Once again, thank you for the great communication and collaboration over the years. It has been a wonderful journey, and it's time for me to move on.

我還要感謝你們所有人、我們的投資者和分析師，感謝你們在我擔任 MediWound 首席財務官期間的支持與合作。正如奧弗所說，我將在 7 月底卸任。能夠領導這樣一支才華橫溢的個人團隊，並引領我們共同取得的金融和商業成就，我感到很榮幸也很高興。我很自豪能夠在推動我們的成長和成功方面發揮關鍵作用，而且我相信公司處於強大的財務狀況，可以在 Ofer 作為首席執行官的新領導下繼續執行臨床和商業項目。作為 MediWound 的首席執行官，協助 Ofer 過渡並為最近的一輪融資做出貢獻以及製定和執行我們的歐洲業務和全球擴張戰略對我來說很重要。通過這些努力，我相信 MediWound 已準備好繼續取得成功。不少，一起工作很有趣。再次感謝您多年來的良好溝通與協作。這是一段美妙的旅程，是時候讓我繼續前進了。

Moving to the financial statement. Total revenues for the full year were $26.5 million compared to $23.8 million for the year ended December 31, 2021, an increase of 12% year-over-year. License revenues were $8.2 million, driven by the $7.5 million of BLA approval milestones from Vericel. Revenues from products were $5.3 million, a decrease of 44% compared to the $9.6 million in 2021 due to BARDA's procurement completion for emergency stockpile. Total revenue for the fourth quarter of 2022 were $11.6 million compared to $5.5 million in the parallel period, primarily driven by the dealer approval milestone of $7.5 million from Vericel. Revenues from products were $1.2 million compared to $1.9 million in the fourth quarter of 2021 due to $1 million decrease in emergency stockpiles procurement by BARDA, partially offset by our European and international sales increase.

轉到財務報表。全年總收入為 2650 萬美元，而截至 2021 年 12 月 31 日止年度為 2380 萬美元，同比增長 12%。受 Vericel 的 750 萬美元 BLA 批准里程碑推動，許可收入為 820 萬美元。產品收入為 530 萬美元，與 2021 年的 960 萬美元相比下降了 44%，原因是 BARDA 完成了應急儲備的採購。 2022 年第四季度的總收入為 1160 萬美元，而同期為 550 萬美元，這主要是受 Vericel 經銷商批准里程碑 750 萬美元的推動。產品收入為 120 萬美元，而 2021 年第四季度為 190 萬美元，原因是 BARDA 的緊急庫存採購減少了 100 萬美元，部分被我們的歐洲和國際銷售額增長所抵消。

Gross profit for the year was $13.2 million or 50% of net revenues compared to a gross profit of $8.8 million or 37% of net revenues for the same period in 2021. Gross profit for the quarter was $8.2 million or 70% of net revenues compared to a gross profit of $1.5 million or 28% of net revenues for the fourth quarter of 2021. Both for the full year and the quarter, gross margin improvements were driven by the $7.5 million milestone payment from Vericel from the BLA approval.

全年毛利為 1320 萬美元，占淨收入的 50%，而 2021 年同期毛利為 880 萬美元，占淨收入的 37%。本季度毛利為 820 萬美元，占淨收入的 70% 2021 年第四季度的毛利潤為 150 萬美元，占淨收入的 28%。無論是全年還是本季度，毛利率的提高都得益於 Vericel 獲得 BLA 批准的 750 萬美元里程碑付款。

Total operating expenses for the full year of 2022 were $21.5 million versus $20 million in 2021. Total operating expenses for the fourth quarter were $6 million compared to $5.1 million in the fourth quarter of 2021. Both for the full year and the fourth quarter of 2022, the increase in total expenses was primarily driven by onetime expense related to the BLA approval and the management change.

2022 年全年總運營費用為 2150 萬美元，而 2021 年為 2000 萬美元。第四季度總運營費用為 600 萬美元，而 2021 年第四季度為 510 萬美元。2022 年全年和第四季度均如此，總費用的增加主要是由與 BLA 批准和管理層變動相關的一次性費用推動的。

Operating loss for the full year was $8.3 million compared to an operating loss of $11.2 million for the year ended December 31, 2021. Operating profit for the quarter was $2.1 million compared to a loss of $3.5 million in the fourth quarter of 2021. The improvement was primarily driven by the $7.5 million milestone payment from Vericel upon the BLA approval.

全年營業虧損為 830 萬美元，而截至 2021 年 12 月 31 日止年度營業虧損為 1120 萬美元。本季度營業利潤為 210 萬美元，而 2021 年第四季度為虧損 350 萬美元。改善主要是由 Vericel 在 BLA 批准後支付的 750 萬美元里程碑付款推動的。

Net loss for the full year was $19.6 million or $3.93 per share compared to a net loss of $13.6 million or $3.50 per share for the year ended December 31, 2021. Net loss for the quarter was $7.5 million or $1.18 per share compared to a net loss of $4.2 million or $1.07 per share for the fourth quarter of 2021. The increase in loss for the full year and the quarter was due to noncash financial expenses derived from the September and October fundraising warrant revaluation. Adjusted EBITDA for the full year was a loss of $4.4 million compared to a loss of $8.3 million for the year ended December 31, 2021. Adjusted EBITDA for the fourth quarter was a profit of $3.4 million compared to a loss of $2.9 million for the fourth quarter of 2021.

全年淨虧損為 1960 萬美元或每股 3.93 美元，而截至 2021 年 12 月 31 日止年度淨虧損為 1360 萬美元或每股 3.50 美元。本季度淨虧損為 750 萬美元或每股 1.18 美元，而淨虧損為2021 年第四季度虧損 420 萬美元或每股虧損 1.07 美元。全年和本季度虧損增加是由於 9 月和 10 月籌資權證重估產生的非現金財務費用。全年調整後 EBITDA 虧損 440 萬美元，而截至 2021 年 12 月 31 日止年度虧損 830 萬美元。第四季度調整後 EBITDA 盈利 340 萬美元，第四季度虧損 290 萬美元2021 年季度。

Moving now to the balance sheet highlights. As of December 31, 2022, MediWound had $34.1 million in cash and short-term investments compared with $11 million as of December 31, 2021. MediWound utilized $11.9 million to fund its operating activities and $3.1 million for continued liabilities in capital expenditures during 2022. In February 2023, the company received a $7.5 million milestone payment from its partner, Vericel, for U.S. FDA approval of NexoBrid in December 2022. February 7, 2023, the company completed a public offering, which provided the company with additional $27.5 million in gross proceeds. The company expects cash used for 2023 to be in the range of $16 million to $18 million. Based on the company's current operating plan, we believe that existing cash and cash equivalents will support its operations through 2022.

現在轉到資產負債表亮點。截至2022年12月31日，MediWound擁有3410萬美元的現金和短期投資，而截至2021年12月31日為1100萬美元。MediWound在2022年期間利用1190萬美元為其經營活動提供資金，310萬美元用於資本支出中的持續負債。 2023年2月，公司收到其合作夥伴Vericel 750萬美元的里程碑付款，用於美國FDA於2022年12月批准NexoBrid。2023年2月7日，公司完成公開發行，為公司提供了額外的2750萬美元的總收入收益。該公司預計 2023 年使用的現金將在 1600 萬至 1800 萬美元之間。根據公司目前的運營計劃，我們認為現有現金和現金等價物將支持其運營至 2022 年。

With that, I have concluded my financial overview, and I will now turn the call back to Ofer. Ofer?

至此，我完成了我的財務概覽，現在我將把電話轉回給 Ofer。報價？

Thank you, Boaz.

謝謝你，波阿斯。

Our positive momentum continues, and we expect 2023 to be driven by several significant categories, strong growth and meaningful revenue for NexoBrid fueled by commercial launches in key markets such as the United States, India and Japan; scaling up our manufacturing facility to ensure we can meet the growing global demand for our products; initiating a Phase III pivotal trial for EscharEx; targeting $1 billion market opportunity; and finally, we look forward to sharing more about our MW005 development plans for BCC.

我們的積極勢頭仍在繼續，我們預計 2023 年將受到幾個重要類別的推動，NexoBrid 的強勁增長和可觀的收入將受到美國、印度和日本等主要市場的商業發布的推動；擴大我們的製造設施，以確保我們能夠滿足全球對我們產品不斷增長的需求；啟動 EscharEx 的 III 期關鍵試驗；瞄準 10 億美元的市場機會；最後，我們期待分享更多關於 BCC 的 MW005 開發計劃。

With that, we would now like to open the call for any questions you may have. Operator?

有了這個，我們現在想打開您可能有的任何問題的電話。操作員？

(Operator Instructions) And our first question comes from Josh Jennings from TD Cowen.

（操作員說明）我們的第一個問題來自 TD Cowen 的 Josh Jennings。

Congratulations on all the progress in 2022. Boaz, good luck in your next chapter. I was hoping to just start with asking a couple on EscharEx. And first, just on the back and forth with the FDA and finalizing the clinical development program from here, clinical trial design. Anything you can share just in terms of incremental color or are there any sticking points or any other details you can provide would be helpful to understand. I know that you said the time line for when you expect those -- the finalization of the design, but I was wondering if there are anything more you could share on that.

祝賀你在 2022 年取得的所有進步。波阿斯，祝你在下一章好運。我希望從在 EscharEx 上詢問一對夫婦開始。首先，就在與 FDA 的來回交流中，並從這裡完成臨床開發計劃，臨床試驗設計。您可以僅就增量顏色分享的任何內容，或者是否存在任何癥結點或您可以提供的任何其他細節都將有助於理解。我知道你說過你期望這些的時間線——設計的最終確定，但我想知道你是否還有更多可以分享的內容。

Josh, so as I said, we submitted the protocol design for the FDA for their review. The final trial design will be announced once the discussions are done. We don't anticipate any issues. I think we've got very good answer from the FDA. And I think that we are in the last stages of having their understanding in how the Phase III will look like. As I said that in parallel, we plan to submit a request to EMA for a scientific advice and also to understand how the clinical development plan of EscharEx looks in Europe. This global approach should not have an impact on the time line. So we still estimate that the trial will start in 2023. As for how the trial will look like, I reiterate what I said in the previous call. We will try to make it as close as possible to the Phase II study in order for all the investors and strategic players understand that we are going to meet the endpoint with no issues.

喬希，正如我所說，我們向 FDA 提交了協議設計以供他們審查。最終試驗設計將在討論完成後公佈。我們預計不會出現任何問題。我認為我們從 FDA 那裡得到了很好的答复。我認為我們正處於了解他們對第三階段的樣子的最後階段。正如我同時所說，我們計劃向 EMA 提交請求以尋求科學建議，並了解 EscharEx 的臨床開發計劃在歐洲的情況。這種全球方法不應對時間表產生影響。所以我們仍然估計審判會在2023年開始。至於審判會是什麼樣子，我重申一下我在之前的電話會議中說過的話。我們將努力使其盡可能接近 II 期研究，以便所有投資者和戰略參與者了解我們將毫無問題地達到終點。

Thanks for reviewing that again. I appreciate it. And I wanted to ask just about partnership opportunities for EscharEx and MW005. How should investors be thinking about future partnership opportunities? It sounds like, I mean, you're moving forward with EscharEx independently. But should we think that down the line, there could still be partnership opportunities?

感謝您再次審查。我很感激。我想問一下 EscharEx 和 MW005 的合作機會。投資者應如何考慮未來的合作機會？聽起來，我的意思是，您正在獨立推進 EscharEx。但我們是否應該認為，未來仍有合作機會？

It's a very good question. As you can imagine, we discussed it internally because there is all sorts of gains -- the attention of all the wound care specialists and many important strategic players in the market. Everyone is looking these days for a topical debriding agent with the advantages of EscharEx being able to debride a wound in 1 week. We are very lucky to have the funding and flexibility to be very -- to discuss a deal that will be very favorable for MediWound. Having said that, we are not speaking about North America licensing because this is the big market and it's going to stay with us. Having said that, we are in discussion with several potential partners regarding a collaboration in the Phase III study. Our cash position and our track record is exceeding in size. I will remind you that we succeeded in 14 out of 14 clinical trials in a few indications. The cash position that the track record enables us to have the stability in those discussions, but I can tell you that there is a lot of interest.

這是一個很好的問題。正如您所想像的那樣，我們在內部進行了討論，因為有各種各樣的收穫——所有傷口護理專家和市場上許多重要戰略參與者的關注。現在每個人都在尋找一種局部清創劑，其優點是 EscharEx 能夠在 1 週內清創傷口。我們非常幸運能夠獲得資金和靈活性來討論一項對 MediWound 非常有利的交易。話雖如此，我們並不是在談論北美許可，因為這是一個大市場，它將留在我們身邊。話雖如此，我們正在與幾個潛在合作夥伴討論 III 期研究的合作事宜。我們的現金頭寸和我們的業績記錄超出了規模。我會提醒您，我們在 14 項臨床試驗中有 14 項針對一些適應症取得了成功。往績記錄使我們能夠在這些討論中保持穩定的現金狀況，但我可以告訴你，有很多興趣。

As for MW005, these pharma companies interested in that. We are waiting patiently to Q3 2023, and we are going to see if MW005 has the same qualities as NexoBrid has with burns and EscharEx for chronic wound. If the results remain positive, I believe we have a strong collaboration for that.

至於MW005，這些製藥公司對此很感興趣。我們正在耐心等待 2023 年第三季度，我們將看看 MW005 是否具有與 NexoBrid 治療燒傷和 EscharEx 治療慢性傷口相同的品質。如果結果仍然是積極的，我相信我們將為此進行強有力的合作。

Excellent. I appreciate that. And then last question just on NexoBrid. It sounds like Vericel is expecting somewhere between $4 million to $8 million in NexoBrid revenues once they launch that product in the U.S. and it sounds like second quarter of '23. Can you just remind us of kind of the royalty flow through and how that could impact the revenue line for MediWound in 2023?

出色的。我很感激。然後是關於 NexoBrid 的最後一個問題。聽起來 Vericel 預計一旦 NexoBrid 在美國推出該產品，其收入將在 400 萬至 800 萬美元之間，這聽起來像是 23 年第二季度。您能否提醒我們一些特許權使用費的流向，以及這將如何影響 MediWound 在 2023 年的收入線？

Josh, thank you for your comments in the beginning. And definitely, it was a real pleasure working with you and your team. So regarding the question for Vericel, so the economics going forward, after the $7.5 million was received in February is 3 kind of streamlines for the revenue. One is the transfer pricing of the product and the cost ratio. Second, stream of revenues is royalties, which is a high single-digit royalty upon sales of Vericel's end customers. And the third would be the milestones upon reaching a certain threshold of revenues then they get a certain percentage. And I think to that, you can take around 20%, 25% of the economic conversion that would be in our P&L.

喬希，謝謝你一開始的評論。當然，與您和您的團隊合作真的很愉快。所以關於 Vericel 的問題，所以在 2 月份收到 750 萬美元後，未來的經濟是 3 種收入流水線。一是產品的轉讓定價和成本比率。其次，收入流是特許權使用費，這是 Vericel 最終客戶銷售的高個位數特許權使用費。第三個是達到一定收入門檻的里程碑，然後他們會獲得一定的百分比。我認為，你可以在我們的損益表中獲得大約 20%、25% 的經濟轉換。

We have a question now from Francois Brisebois from Oppenheimer.

Oppenheimer 的 Francois Brisebois 現在有一個問題。

Best of luck, Boaz, on the next venture here. On my side, I just wanted to touch on -- in terms of EscharEx, you talked about keeping it to yourself in the U.S. just based on its massive opportunity. Can you just maybe help us understand how many physicians are out there? And what kind of sales force would be necessary? What kind of maybe numbers was to be able to target the physician?

祝你好運，波阿斯，在這裡的下一次冒險。在我這邊，我只是想談一談——就 EscharEx 而言，你談到在美國將其保密是基於其巨大的機會。你能不能幫助我們了解那裡有多少醫生？需要什麼樣的銷售人員？什麼樣的可能數字能夠針對醫生？

Frank, so first of all, the reason for us is EscharEx, the North American right. And the reason that it is our top priority to have it approved is, first of all, if we target a market of $2 billion, I think we made that very clear in our previous presentation. Our first priority is to have it approved. Currently, we look at the Santyl sales, Santyl sales are between 300 and $400 million annually. According to market research that was done by an external party, we saw that not only that we draw a significant share from the current enzymatic debriding agent, but also we draw a significant share from the other modalities, mainly the sharp debridement, which is used by 50% of the physicians. It's a very big market. Maybe one should -- we'll get ready for that commercially in the next few years. Since I see the interest from the big players, I don't believe that in the end of the story, maybe one will be the one that will approach the final users. Having said that, we are preparing for that.

弗蘭克，首先，我們的原因是北美權利的 EscharEx。首先，如果我們的目標是 20 億美元的市場，我認為我們在之前的演講中已經非常清楚地說明了這一點，因此我們的首要任務是讓它獲得批准。我們的首要任務是讓它獲得批准。目前，我們看一下 Santyl 的銷售額，Santyl 的年銷售額在 300 到 4 億美元之間。根據第三方進行的市場調查，我們看到不僅我們從目前的酶促清創劑中獲得了很大的份額，而且我們從其他方式中也獲得了很大的份額，主要是銳器清創，它被用於50%的醫生。這是一個非常大的市場。也許有人應該——我們將在未來幾年內為商業化做好準備。由於我看到了大公司的興趣，我不相信在故事的最後，也許會有人接近最終用戶。話雖如此，我們正在為此做準備。

Okay. And then in terms of EscharEx and you talked about approaching the EMA. Any reason here in terms of maybe historically in the space that EMA and FDA would want different -- would require different things for trial design? Or is there any wait from the U.S. maybe on to see what the EMA does? Or are these completely independent and there shouldn't be much impact there?

好的。然後就 EscharEx 而言，你談到了接近 EMA。就歷史上 EMA 和 FDA 想要不同的空間而言，這裡有任何理由——試驗設計需要不同的東西嗎？或者美國是否有任何等待，看看 EMA 會做什麼？或者這些是完全獨立的，應該不會有太大影響嗎？

So it's a very interesting question. Since I tackled that basically in the first couple of months that I became a CEO, so MediWound has a history of developing a drug for severe burns. It was approved by EMA, only a few years later, it was approved by the FDA. The requirements were quite different, even the endpoints were different. Having said that, when a pediatric label extension was discussed, both agencies, EMA and FDA agreed that the company will do the same trial for both agencies. We are following EMA guidelines, and we are looking closely at the FDA guidelines. And we also, of course, as we communicated, we also spoke with the FDA a couple of times. So we know what is required from the FDA. We think we know how to adjust this to EMA's requirement as well, but these are not identical requirements for a Phase III study. Having said that, the bar for the FDA is considered higher. Therefore, I think that we are in a good shape, and this is the reason that we estimated that approaching EMA regarding our Phase III study will not change the time line.

所以這是一個非常有趣的問題。因為我基本上是在成為 CEO 的頭幾個月就解決了這個問題，所以 MediWound 有開發嚴重燒傷藥物的歷史。它獲得了 EMA 的批准，僅僅幾年後，它就獲得了 FDA 的批准。要求完全不同，甚至端點也不同。話雖如此，當討論兒科標籤延期時，EMA 和 FDA 兩個機構都同意該公司將為這兩個機構進行相同的試驗。我們遵循 EMA 指南，並密切關注 FDA 指南。當然，在我們溝通的同時，我們也與 FDA 進行了幾次交談。所以我們知道 FDA 的要求是什麼。我們認為我們也知道如何根據 EMA 的要求進行調整，但這些與 III 期研究的要求並不相同。話雖如此，FDA 的門檻被認為更高。因此，我認為我們處於良好狀態，這就是我們估計就我們的 III 期研究接近 EMA 不會改變時間表的原因。

Understood. Okay. And then lastly, the pediatric label expansion hopefully in the middle of this year in Europe. Can you just maybe help us understand how much -- how big the pediatric footprint in the market commercially. And then just maybe any thoughts about label expansion into pediatrics in the U.S.?

明白了。好的。最後，兒科標籤有望在今年年中在歐洲擴展。你能不能幫助我們了解多少——兒科在商業市場上的足蹟有多大。然後可能有任何關於標籤擴展到美國兒科的想法？

Okay. So let's start with the first question. Pediatric patients represent about 25% to 30% of the total burn population. Having said that, the market is a little bit smaller than 25% to 30% because the people -- the children are smaller than adult patients. Pediatric population often face painful surgery, and it can be very traumatic for the young patients and their families. So we believe that approval will allow the pediatric patients and their family a much better of experience. So we think that this will have a big impact on the demand of NexoBrid in Europe once it is approved. As for the United States, we have also a plan to submit for pediatric label expansion. It's the same clinical trial. We did the same clinical trial for EMA and the FDA. Therefore, we don't think that we don't see any issues with approval. Having said that, the time line will be a little bit shifted because we started with Europe first.

好的。那麼讓我們從第一個問題開始。兒科患者約佔燒傷總人數的 25% 至 30%。話雖如此，市場比 25% 到 30% 略小一些，因為兒童比成年患者要小。兒科人群經常面臨痛苦的手術，這對年輕患者及其家人來說可能是非常痛苦的。因此，我們相信批准將使兒科患者及其家人獲得更好的體驗。所以我們認為，一旦獲得批准，這將對 NexoBrid 在歐洲的需求產生重大影響。至於美國，我們也有提交兒科標籤擴展的計劃。這是相同的臨床試驗。我們為 EMA 和 FDA 做了同樣的臨床試驗。因此，我們不認為我們沒有看到批准方面的任何問題。話雖如此，時間線會有所改變，因為我們首先從歐洲開始。

We now have a question from Swayampakula Ramakanth from H.C. Wainwright.

我們現在有來自 H.C. 的 Swayampakula Ramakanth 的問題。溫賴特。

This is RK from H.C. Wainwright. Boaz, it's been a great pleasure working with you. Certainly, we'll miss you, and good luck as you move on progress.

這是 H.C. 的 RK。溫賴特。波阿斯，很高興與你合作。當然，我們會想念你，祝你在進步的過程中好運。

Thank you, RK.

謝謝你，RK。

So Ofer, a couple of questions from me. On the NexoBrid expanded access program, you stated that about 200-odd patients have been treated so far. Just trying to understand what your learnings are from that? And how are you and Vericel utilizing that information as you prepare for the commercial launch?

那麼 Ofer，我有幾個問題。在 NexoBrid 擴展訪問計劃中，您表示到目前為止已有大約 200 多名患者接受了治療。只是想了解您從中學到了什麼？在準備商業發佈時，您和 Vericel 如何利用這些信息？

RK, good to hear from you. So as I said, we have successfully treated 206 patients at 26 leading burn centers in the United States. At some point, we will need some data from those treatments. But what I can share is that they are very consistent with the clinical trial. When we said that the patients were treated successfully, we mean successfully NexoBrid is very effective, 95%, 96% of the applications are a success in 4 hours. So we just see it as a kind of an education for the U.S. burn centers and specialists.

RK，很高興收到你的來信。正如我所說，我們已經在美國 26 個領先的燒傷中心成功治療了 206 名患者。在某些時候，我們將需要這些治療的一些數據。但我可以分享的是，它們與臨床試驗非常一致。當我們說患者治療成功時，我們的意思是 NexoBrid 非常有效，95%、96% 的應用程序在 4 小時內成功。所以我們只是將其視為對美國燒傷中心和專家的一種教育。

I think this expanded access trial will support Vericel's launch because, I don't know, something like 20% of the centers in the United States are treating patients with that drug regularly. Having said that, don't forget that the approval currently is only for adults. And in the expanded access program, we are also treating pediatric population. So I think it will support -- if I go back to the question that Frank asked me earlier, it would also support the pediatric indication expansion because we will keep on recruiting patients in this study, although NexoBrid will be approved in the United States will be available in the United States commercially very soon.

我認為這個擴大的准入試驗將支持 Vericel 的推出，因為，我不知道，美國大約 20% 的中心正在定期用這種藥物治療患者。話雖如此，但不要忘記目前的批准僅適用於成年人。在擴展訪問計劃中，我們也在治療兒科人群。所以我認為它會支持——如果我回到 Frank 早些時候問我的問題，它也會支持兒科適應症的擴展，因為我們將繼續在這項研究中招募患者，儘管 NexoBrid 將在美國獲得批准很快就會在美國上市。

Fantastic. Then regarding your obligation to BARDA, if there's any, can you kind of tell us or highlight for '23?

極好的。那麼關於你對 BARDA 的義務，如果有的話，你能告訴我們或強調 '23 嗎？

Can you repeat the question? Is that obligation to BARDA?

你能重複這個問題嗎？這是對 BARDA 的義務嗎？

Do you have any obligation to BARDA in '23?

你在 23 年對 BARDA 有任何義務嗎？

Yes. We have, as you know, BARDA has the kind of a replenishment program, $16.5 million done in the previous 2 years. We are currently negotiating 2023 and 2024. BARDA also supports our sulfur mustard program. As you know, after NexoBrid was approved, we started pushing the $43 million grant that we got from them in order to have a debriding agent also for sulfur mustard gas injuries. So if we look at 2023, I would expect for additional stockpile commitment, a little bit more of fundraising of financing of R&D staff and especially the sulfur mustard program.

是的。如您所知，我們有 BARDA 的那種補充計劃，在過去 2 年中完成了 1650 萬美元。我們目前正在就 2023 年和 2024 年進行談判。BARDA 也支持我們的硫芥計劃。如您所知，在 NexoBrid 獲得批准後，我們開始推動從他們那裡獲得的 4300 萬美元贈款，以便獲得一種清創劑也用於硫芥氣傷害。因此，如果我們展望 2023 年，我預計會有更多的庫存承諾，為研發人員籌集更多資金，尤其是硫芥計劃。

Okay. My last question is on the manufacturing facility. You said that it's progressing well. But do you -- can you give us a little bit on the time line for commissioning it? And also, is that a needed step for a successful launch of NexoBrid or these are independent events?

好的。我的最後一個問題是關於製造設施的。你說進展順利。但是你 - 你能給我們一些關於調試它的時間表嗎？而且，這是成功推出 NexoBrid 的必要步驟還是這些是獨立事件？

Okay. First of all, it's an independent event. We are working in order to meet the time lines that we communicated to the market of the Q2 U.S. launch. But you are right -- (technical difficulty)

好的。首先，這是一個獨立的事件。我們正在努力滿足我們向美國第二季度發布市場傳達的時間表。但你是對的——（技術難度）

I'm sorry. I think we lost a line here. Let me check back with the presenters. Please hold on. We have the speakers back. Sorry for that glitch.

對不起。我想我們在這裡漏了一條線。讓我和主持人核實一下。請暫停。我們有揚聲器回來。對不起那個小故障。

Yes. Sorry about that.

是的。對於那個很抱歉。

Yes, please go ahead. Let me put the questioner back as well. Okay. Everybody is live now. Go ahead, please.

是的，請繼續。讓我把提問者也放回去。好的。現在每個人都活著。請繼續。

Okay. I'm sorry about that. I think it's Boaz boat. So I'm going back to speak about the manufacturing. So as I said, our current sales are limited by our production capacity. Having said that, we are going to meet the launch requirement. Vericel is a very important partner for us. This year is going to be a special one because on top of the demand that we have from the market, we also need to manufacture EscharEx for our Phase II trial. So we have initiated the scale-up of the manufacturing facility immediately after we raised the capital in September 2022. The total cost is something like $10 million to $12 million, but we expect 30% to be covered by all kind of grants. Since it's a sterile manufacturing facility, the process of the scaling up will take approximately 24 months. It's not something that you can do in 5 months because there are a lot of regulatory affairs that are involved. But we are working very hard in order to execute and make sure that we are doing it on time. And then all the gaps will be recovered.

好的。對此我感到很抱歉。我認為這是波阿斯船。所以我要回過頭來談談製造業。所以正如我所說，我們目前的銷售額受到我們生產能力的限制。話雖如此，我們將滿足發布要求。 Vericel 是我們非常重要的合作夥伴。今年將是特殊的一年，因為除了市場需求之外，我們還需要為我們的 II 期試驗製造 EscharEx。因此，我們在 2022 年 9 月籌集資金後立即開始擴大製造設施。總成本約為 1000 萬至 1200 萬美元，但我們預計 30% 將由各種贈款支付。由於它是一個無菌生產設施，因此擴大規模的過程大約需要 24 個月。這不是你可以在 5 個月內完成的事情，因為涉及到很多監管事務。但我們正在非常努力地執行並確保我們按時完成。然後所有的差距將被恢復。

(Operator Instructions) The question now comes from Michael Okunewitch from Maxim Group.

（操作員說明）現在的問題來自 Maxim Group 的 Michael Okunewitch。

Congrats on the great progress over the last couple of months. And also, Boaz, I'd like to wish you luck with the next steps in your career.

祝賀過去幾個月取得的巨大進步。還有，波阿斯，我希望你在職業生涯的下一步中好運。

Thank you.

謝謝。

So you guys have done a lot to shore up your balance sheet. You have 3 years -- 3 to 4 years of cash at this point. Could you talk a bit about how you plan to leverage that balance sheet? Is there anything in your portfolio that would benefit from increased funds to accelerate programs? Are you looking at any potential M&A targets? Or is this best used to just keep your balance sheet strong and provide funding through that Phase III for EscharEx?

所以你們做了很多工作來支撐你們的資產負債表。此時你有 3 年——3 到 4 年的現金。你能談談你打算如何利用資產負債表嗎？您的投資組合中有什麼可以從增加資金以加速計劃中受益的嗎？您是否正在尋找任何潛在的併購目標？或者這是否最好用於保持您的資產負債表強勁並通過 EscharEx 的第三階段提供資金？

Maybe I'll start and Boaz will add if needed. So if you ask me, 2 months ago, I would have told you that we have enough cash to do the Phase III study and enough cash for the scale-up manufacturing facility because these were our requirements, and we communicated that we have cash to go through 2025. Having said that, we got a reverse inquiry from a very strong investor for an additional investment, making sure that we are able to accelerate the EscharEx effort. And the reason for accelerating it because if we are aiming a very significant market for many hundreds of millions of dollars in sales, let's make sure that we get there quicker.

也許我會開始，波阿斯會在需要時補充。所以，如果你在 2 個月前問我，我會告訴你我們有足夠的現金來進行 III 期研究，也有足夠的現金用於擴大生產設施，因為這些是我們的要求，我們溝通過我們有現金來到 2025 年。話雖如此，我們收到了一位非常強大的投資者的反向詢問，要求進行額外投資，以確保我們能夠加快 EscharEx 的努力。之所以加速它，是因為如果我們的目標是一個非常重要的市場，銷售額達數億美元，那麼我們要確保我們更快地到達那裡。

So if you look at the numbers, $66 million reduced from that $25 million for a Phase III trial ballpark and another $10 million for the scale-up efforts. You will see that we have enough capital to do whatever is required. We feel very comfortable these days in these markets to have a cushion of a few tens of millions of dollars. We will not run for adventures, buying assets now because we think that we have a very strong product, which is EscharEx, which will generate a significant value for our shareholders. And NexoBrid is profitable, and we will make sure that we increase the revenues quite substantially. I think if we focus on those 2 efforts, the value of MediWound will increase substantially. Of course, if something opportunistic will arise, we can discuss it.

因此，如果你看一下這些數字，III 期試驗球場的 2500 萬美元減少了 6600 萬美元，而擴大規模的工作又減少了 1000 萬美元。你會看到我們有足夠的資金來做任何需要做的事情。這些天來，我們在這些市場上擁有數千萬美元的緩衝資金感到非常自在。我們不會為了冒險而奔波，現在就購買資產，因為我們認為我們擁有非常強大的產品，即 EscharEx，它將為我們的股東創造巨大的價值。 NexoBrid 是盈利的，我們將確保我們大幅增加收入。我認為，如果我們專注於這兩項努力，MediWound 的價值將會大幅增加。當然，如果出現機會主義的事情，我們可以商量。

And maybe just, Mike, from a numbers perspective on top of $34 million that we had end of 2022, we already received the $7.5 million and then we have a recent fundraising, so you're talking about $66 million, which should surprise us through 2026. And also on top of that, we have the commercial sale of NexoBrid, definitely given the recent marketing approvals in India, in Japan and in the U.S. now. We believe that there are going to be increase of 50% in the product revenues, which, of course, would strengthen our balance sheet. And just to maybe to summarize on top of that, once we have the facility scale up, we will be able to meet the growing demand. And of course, that, I think, will take us out profitability in the future years.

也許只是，邁克，從數字的角度來看，我們在 2022 年底獲得了 3400 萬美元，我們已經收到了 750 萬美元，然後我們最近進行了籌款，所以你說的是 6600 萬美元，這應該會讓我們感到驚訝2026 年。最重要的是，我們有 NexoBrid 的商業銷售，這肯定是因為最近在印度、日本和美國獲得了營銷許可。我們相信產品收入將增加 50%，這當然會加強我們的資產負債表。最重要的是，一旦我們擴大設施規模，我們將能夠滿足不斷增長的需求。當然，我認為，這將使我們在未來幾年失去盈利能力。

All right. And then I'd like to follow up on the EscharEx development plans. Obviously, VLUs are the immediate opportunity we've discussed why that's a particularly attractive market. But how are you looking at the potential use in DFUs? Is that something where you think about a parallel Phase III program?

好的。然後我想跟進 EscharEx 的開發計劃。顯然，VLU 是我們討論過為什麼這是一個特別有吸引力的市場的直接機會。但是您如何看待 DFU 的潛在用途？這是您考慮並行 III 期計劃的地方嗎？

Again, it's a very good question. As I mentioned, I think earlier in this Q&A session, our top priority is to get an approval of EscharEx. We look at the current enzymatic agent, we see our superiority compared to it, and we want to get an approval ASAP. Unfortunately, FDA says that how to build wound or chronic wound is not an indication. The indication of VLUs, DFUs, pressure ulcers et cetera. We know -- we chose venous leg ulcers because the unmet need there is much bigger. Some of the discussions that we are doing with strategic players is trying to broaden our efforts around additional wound types. We are looking into it. I don't think that we will need to do another Phase III study, maybe we will need to do another bridging study or something like that. But our top priority currently is to get an approval, being able to making sure that we collect data that justifies a very high pricing for our drug. And after we are there, we think we can broaden the indication for additional type of wounds.

同樣，這是一個非常好的問題。正如我提到的，我認為在本次問答環節的早些時候，我們的首要任務是獲得 EscharEx 的批准。我們看看目前的酶促劑，我們看到了我們與之相比的優勢，我們希望盡快獲得批准。不幸的是，FDA 表示，如何建立傷口或慢性傷口並不是一個適應症。 VLU、DFU、壓瘡等的適應症。我們知道——我們選擇腿部靜脈潰瘍是因為那裡未滿足的需求要大得多。我們正在與戰略參與者進行的一些討論試圖擴大我們圍繞其他傷口類型的努力。我們正在調查。我不認為我們需要進行另一項 III 期研究，也許我們需要進行另一項橋接研究或類似的研究。但我們目前的首要任務是獲得批准，能夠確保我們收集的數據能夠證明我們的藥物定價非常高。在我們到達那里之後，我們認為我們可以擴大對其他類型傷口的適應症。

All right. And then just one final one for me and I'll hop back in the queue. I'd like to ask a little bit about the opportunities for NexoBrid in Japan and India. Obviously, Japan is a major market and doesn't need much introduction. But in India, we might expect lower pricing. Is that offset by the massive population? Can you just give a bit more color on how those markets look for burn debridement?

好的。然後是我的最後一個，我會跳回到隊列中。我想問一下 NexoBrid 在日本和印度的機會。顯然，日本是一個主要市場，不需要太多介紹。但在印度，我們可能會期待更低的價格。這會被龐大的人口抵消嗎？您能否更詳細地說明這些市場如何尋找燒傷清創術？

Yes. So Japanese market definitely is one of the biggest health care markets in the world. Probably if we want to look at the numbers, so we see that probably around $1.5 million that we see in the first year. And then definitely, we're very excited with the enthusiasm of Kaken, which is a global pharmaceutical company and our distributor in Japan from the launch. The launch is expected by midyear. And of course, we expect it to grow in 2024 and 2025.

是的。所以日本市場絕對是世界上最大的醫療保健市場之一。如果我們想看看這些數字，我們可能會看到第一年大約有 150 萬美元。當然，我們對 Kaken 的熱情感到非常興奮，Kaken 是一家全球製藥公司，也是我們在日本的經銷商。預計將在年中推出。當然，我們預計它會在 2024 年和 2025 年增長。

Regarding India, this is a partnership that we have with BSV, which is also Indian global pharmaceutical company. I agree or hear about the size of population. But I think India is a little bit more complex picture because mass of the population is not covered under any kind of health of public health care insurance. So we're still kind of running this market. It's the biggest market, by the way, by the number of severe burn patients by far. And I think we're still learning. I would expect it around $0.5 million in the first year, and then I think we'll be able to provide more details about this market.

關於印度，這是我們與 BSV 的合作夥伴關係，BSV 也是印度的全球製藥公司。我同意或聽說人口規模。但我認為印度的情況要復雜一些，因為大量人口沒有享受任何形式的公共醫療保險。所以我們仍然在經營這個市場。順便說一句，就目前嚴重燒傷患者的數量而言，它是最大的市場。我認為我們仍在學習。我預計第一年的收入約為 50 萬美元，然後我認為我們將能夠提供有關該市場的更多詳細信息。

I will just add one trivia information. India is the only market in the world in which NexoBrid didn't get the orphan indication. The number of current patients there are extremely unproportional to the size of the population, which is higher regardless. But as Boaz said, $0.5 million this year, and we are learning the market, we will be able to give some more guidance later this year. And again, we are limited by our capacity to manufacture. So this year, we do not plan to sell more to India more than $0.5 million.

我將只添加一個瑣事信息。印度是世界上唯一一個 NexoBrid 沒有獲得孤兒適應症的市場。目前那裡的患者數量與人口規模極不成比例，無論如何都更高。但正如 Boaz 所說，今年是 50 萬美元，我們正在了解市場，我們將能夠在今年晚些時候提供更多指導。同樣，我們受到製造能力的限制。所以今年，我們不打算向印度銷售超過 50 萬美元的產品。

Michael, we will take another question from you if you so desire.

邁克爾，如果你願意，我們會再問你一個問題。

It was because I got bumped off the call before, so you might have queuing the queue for me.

因為我之前被打斷了電話，所以你可能幫我排了隊。

Okay, all right. At this time, we have no further questions then, and I would like to turn the call back over to management for some closing remarks. Thank you.

好的，好的。目前，我們沒有進一步的問題，我想將電話轉回給管理層，聽取一些結束語。謝謝。

Okay. So thank you, everyone, for joining us today. We look forward to updating you again in our next call or speaking to you offline. Bye-bye.

好的。所以，謝謝大家今天加入我們。我們期待在下次通話或線下與您交談時再次更新您的信息。再見。

Thank you, everyone, for joining us today. We look forward to updating you again. You may now disconnect.

謝謝大家今天加入我們。我們期待再次為您更新。您現在可以斷開連接。