Q4 2022 Zai Lab Ltd Earnings Call
Speaker 2: You.
Operator: As a reminder, today's call is being recorded. It's now my pleasure to turn the floor over to Billy Chu, CF Financial Officer of ZayLab, who will make introductory comments. Thank you, operator.
Speaker 2: I.
Billy Chu: Good morning, good evening, and welcome everyone. Zylav recently issued a press release providing the details of the company's full year, 522 financial results, as well as some recent product highlights and corporate updates. The press release is available in the investor relations section of the company's website at ir.orgi-lebutory.com. Today's call will be led by Dr. Samantha Duh, Zylaz founder, chief executive officer, and chairperson. The Approduct provides opening remarks with an overview of 2022 highlights.
Speaker 3: and welcome to Xilab, Fulya and 4th Quarter 2022 Financial Results Conference Call.
Speaker 3: To the call, I'd like to remind you that the audience who are joining via the webcast can refer to the presentation's lives and follow along with management presentation.
Billy Chu: Josh Smiley, chief operating officer, will further discuss key business updates and 2023 strategic priorities. Dr. Rafael Amato, president and head of global development oncology, will discuss advances with our oncology product candidates. Dr. Harold Reinhardt, president and head of global development for neuroscience, autoimmune, and infectious diseases, will speak about progress we have made in those three therapeutic areas, and I will discuss the performance of our market products and conclude with comments on our full year and fourth quarter financial results.
Speaker 3: The slides will be available for download in the industry relations section of Xilab's website after this call. At this time, all participants are listed or removed. Later, we will conduct a question and answer session. An instruction will follow at that time. Other reminder, today's call is being recorded.
Speaker 3: It's now my pleasure to turn the floor over to Billy Choo, CF Financial Officer of Zalab, who will make introductory comments. Thank you, operator. Good morning, good evening, and welcome everyone.
Speaker 4: Xylab recently issued a press release providing details of the company's full year 2022 financial results, as well as some recent product highlights and corporate updates.
Billy Chu: Additional vectors will be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, Xilab will be making certain forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995, including with respect to our business plans and objectives, clinical trials, sales and revenue forecasts for our products and product candidates, regulatory applications, and commercial launches. The forward-looking statements are not guarantees of future performance, and therefore, we should not put undue reliance upon them.
Speaker 4: The press release is available in the investor relations section of the company's website at ir.xylabatory.com. Today's call will be led by Dr. Samantha Do, Xylab's founder, chief executive officer, and chairperson. After Dr. Do provides opening remarks with an overview of 2022 highlights, Josh Smiley, chief operating officer, will further discuss key business updates and 2023 strategic progress.
Billy Chu: These statements are subject to numerous risks and uncertainties, and actual results could differ materially from what we expect due to a variety of factors, including those discussed in our SEC file. At this time, it is my pleasure to call over to Xylev's father, Chief Executive Officer, and Chairperson, Dr. Samantha Duce.
Speaker 4: and conclude with comments on our full year and fourth quarter financial results. Additional ZECAs will be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, Zilab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to our business plans and objectives.
Dr. Samantha Duh: Thank you, Billy. Hello, everyone. Thank you all for joining us today. On this call, I'll discuss highlights from 2022 and what we expect to accomplish in 2023 and in the longer term. In 2017, despite challenges from the COVID-19 pandemic in China, of our four market products, each had substantial sales growth. We made exciting programs across our broad and advanced platforms. Our type of vaccines continue to demonstrate potential.
Speaker 4: clinical trials, sales and revenue forecasts for our products and product candidates, regulatory applications, and commercial launches. These forward-looking statements are not guarantees of future performance.
Speaker 4: not put undue reliance upon them. These statements are subject to numerous risks and uncertainties and actual results could differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings. At this time, it is my pleasure to turn the call over to Zylabs founder, chief executive officer chairperson, Dr. Samantha Dood.
Dr. Samantha Duh: Potential bedcloth and or first in class
Dr. Samantha Duh: The numerous Pactetace data readouts announced during the year, including at a classic, non-smal cell lung Carps tea is schizophrenia, and Agatismat in IPP and GM. They're also pleased to have contributed to several successful graduate studies, including the Tuber Treating Fields Lunar Study.
Speaker 1: Thank you, Billy. Hello, everyone. Thank you all for joining us today.
Speaker 1: On this call, I'll discuss highlights from 2022 and what we expect to accomplish in 2023 and in the longer term.
Dr. Samantha Duh: in the rebel treadmill, Triton One study. We're pleased to have added
Dr. Samantha Duh: I added King Rock, New Zealand, to China's national reinforcement job list in 2023. We further deepen our women's kinds of franchise.
Speaker 1: In 2022, despite challenges from the COVID-19 pandemic in China,
Speaker 1: Our four marketing products each have substantial sales growth and we made exciting programs across our broad and advanced platform.
Dr. Samantha Duh: Through our strategic collaboration with C,
Speaker 5: each had substantial sales growth, and we made exciting programs across our broad and aligned platform.
Dr. Samantha Duh: with Jesus, and we continue to significantly behind our talented global team. Further, building on our solid foundation, Salad is already a leading global bowel tax.
Dr. Samantha Duh: tech with very much scale. The world class test lines under the growing commercial portfolio tax We expect to achieve commercial profitability this year.
Speaker 5: continue to demonstrate potential best-in-class and first-in-class profile globally.
Speaker 5: The numerous passive late phase data readouts announced do later.
Dr. Samantha Duh: and are preparing to launch at least eight additional products and two
Speaker 5: including at a classic inosomal cell lung cancer. Carbs T is keto-freno.
Dr. Samantha Duh: and achieve overall corporate profitability by the end of 2025. We will continue to invest in R&D, as we see with the ones in our product pipelines, including our internal discovery activity, Methodist medicines for patients, use. We also aim to strengthen our portfolio and strategic positioning with potentially transformative aspects and partnerships.
Speaker 5: and I've got teacher marks in ITP and GMG. We're also pleased to have contributors.
Speaker 5: to several successful graduational studies including the tumor-trading field saloona studies and the repotreximid treatment 1 study.
Speaker 5: For a pleased to have cited King Lock and New Zealand to time a national reinforcement job list in 2023, we forwarded different our women's kinds of franchise.
Dr. Samantha Duh: We believe that in a global regulatory world,
Dr. Samantha Duh: will continue to be supportive of either as rated by pharmaceutical companies.
Speaker 5: through our strategic collaboration with CSIS for TSTAC.
Speaker 5: And we continue to significantly enhance our talented global team.
Dr. Samantha Duh: We'll continue to build on this.
Dr. Samantha Duh: in pursuit of our overall goal of improving human health.
Speaker 5: Further, building on our solid foundation, Starlight is already a leading global biotech with very good scale, a world-class pipeline, and a growing commercial portfolio in China.
Dr. Samantha Duh: Human health in China and globally.
Dr. Samantha Duh: I would like to now turn the co-over to John and discuss other key business and 20-
Joshua L. Smiley: 23 strategic priorities in more detail.
Speaker 5: We expect to achieve commercial profitability this year.
Joshua L. Smiley: Priorities The more detail, thank you, Samantha. As Samantha mentioned, in 2022, we continue to attract top talent with deep domain expertise. I'd like to highlight a few recent additions to our global leadership team. In December, we were pleased to welcome Dr. Raphael Amato to our team as president, head of global oncology research and development. Raphael joined us from Aalijine, and he has experience in leading worldwide discovery and clinical development across a broad range of oncology products.
Speaker 5: and are preparing to launch at least eight additional products and achieve overall corporate profitability by the end of 2025.
Speaker 5: We will continue to invest in R&D.
Speaker 5: as we seek good ones in our product pipeline, including our internal discovery activities in the cyber-risk medicine for patients you meet.
Speaker 5: We also aim to strengthen our portfolio and strategic positioning with potentially transformative aspects and partnerships.
Speaker 5: We believe that the global regulatory world will continue to be supportive of either rated by a pharmaceutical company or by a driver.
Joshua L. Smiley: In November 2022, Dr. Peter Huang joined us as our key scientific officer. Dr. Huang will lead and oversee our discovery efforts in translational medicine. We were also pleased to appoint Michelle Venacos to our board of directors in January, 2023. Mr. Benacos brings to the board extensive global leadership and management experience in the biopharmaceutical industry, including more than 25 years of service as an executive at a leading company. His expertise includes a significant amount of commercial experience in China and worldwide.
Speaker 5: We'll continue to build on our success in pursuit of our overall goal of improving human health in China and globally. I would like to now turn the call over to Josh to discuss other key business updates.
Speaker 3: In 2023, strategic priorities in more detail. Josh. Thank you, Samantha. As Samantha mentioned, in 2022, we continue to attract top talent with deep domain expertise.
Speaker 6: I'd like to highlight a few recent additions to our global leadership team. In December , we were pleased to welcome Dr. Rafael Amato to our team as President, Head of Global Oncology Research and Development.
Joshua L. Smiley: We expect 2023 to be a very exciting year for Zai, as he anticipates achieving many significant milestones. First, on the regulatory front for F. Gartigamod, we expect BLA approval and commercial launch for the IV formulation of F. Gartigamod in generalized myasthenia Gravis or GMG in 2023, and a BLA submission for the subcutaneous F-BGG in MEDG in mid-20. We also plan to submit a new drug application to the NMPA for Repokrectinib in Ross1 positive advanced non-small lung cancer this year.
Speaker 6: Raphael joined us from Allogene and he has experience in leading worldwide discovery and clinical development across a broad range of oncology products. In November 2022, Dr. Peter Huang joined us as our chief scientific officer. Dr. Huang will lead and oversee our discovery efforts in translational medicine.
Speaker 6: We're also pleased to appoint Michelle Venacos to our Board of Directors in January 2023. Mr. Venacos brings to the Board extensive global leadership and management experience in the Barth Files Pharmaceutical Industry.
Speaker 6: including more than 25 years of service as an executive at leading companies. His expertise includes a significant amount of commercial experience in China and worldwide.
Joshua L. Smiley: We're also pleased to obtain the NMPA's acceptance of the MDA for solbactorobactum for the treatment of infections caused by Acinibacter Bimamone. Regarding our commercial, We deliver good growth even though we face COVID challenges. And now, with the COVID challenges mostly behind us, we expect strong growth in revenue in 2023. We expect Zajula to become the leader in parps sales for ovarian cancer. In the fourth quarter of 2022, we continue to gain share of hospital sales across all, reaching 39% of total part hospital sales. Since last September, there's been some concern around Zhajula's China label for a very current setting on the back of the U.
Speaker 6: We expect 2023 to be a very exciting year for Xai as he anticipated achieving many significant milestones.
Speaker 6: First, on the regulatory front for F. cartigimod, we expect BLA approval and commercial launch for the IV formulation of F. cartigimod in generalized Myasthenia gravis, or GMG, in 2023, and a BLA submission for the subcutaneous F. cartigimod in GMG in mid-2023.
Speaker 6: We also plan to submit a new drug application to the NMPA for repo tractinists in ROT1 positive advanced non-small cell lung cancer this year.
Joshua L. Smiley: However, as we've previously communicated, we do not expect the U.S. label restriction to impact the approval from the NMPA for Zajula in China. For Kim Locke and New Zeira, we anticipate a significant increase in the sales of both products following their inclusion this year on the NRDL. Moving to key research and clinical development milestones for both ZI and partners, we are looking forward to the top line data readouts for subcutaneous Epler tigimod for chronic inflammatory demyelinating polyradionuclear nucleonropathy in, or CIDP in the second quarter of 2023, and Tempavis vulgaris, or PV, and chronic immune thrombocyopenia, or ITP, in the second half of 2023.
Speaker 6: We're also pleased to obtain the NMPAs acceptance of the NDA for for the treatment of infections caused by Acinobacter baumannii. Regarding our commercial products, we delivered good growth, even though we faced COVID challenges last year. And now with the COVID challenges mostly behind us, we expect strong growth in revenue in 2023.
Speaker 6: We expect the jewel to become the leader in park sales for Provarian Cancer in China this year. In the fourth quarter of 2022, we continue to gain share of hospital sales across all indications reaching 39% of total park hospital sales. Since last September , there's been some concern around the jewel as China label for Ovarian Cancer.
Joshua L. Smiley: We also expect the full data readout of the tumor-treating field lunar study in non-small cell lung cancer in the first half of 2023. We also look forward to the clinical data update for Atagraph in combination with Prembilizumab in the first line for KRAZ G12C mutated non-small cell lung cancer in the second half of 2023. In terms of clinical developments, we will complete enrollment in the Global Phase 3, innovative 301 study of TIBDAF in second and third line cervical cancer in the first half. We also plan to join the Global Phase 3 Fortitude 101 study of Bemritusimab in first-line gastric cancer in China in mid-20. And we anticipate initiating a bridging study of CAR-XT for schizophrenia in China in mid-2020.
Speaker 6: can increase in the sales of both products following their inclusion this year on the NRDL.
Speaker 6: Moving the key research and clinical development milestones for both ZY and partners, we are looking forward to the top line data readouts for subcutaneous effortage and mod for chronic inflammatory demyelinating poly-radio-nucleodoropathy in ORCIDP.
Speaker 6: in the second quarter of 2023 and 10th August Vogueiras or PV and Chronic Immune Zrombo Cytopenia or IPP in the second half of 2023. We also expect the full data readout of the tumor treating field lunar study in non-small cell lung cancer in the first half of 2023.
Speaker 6: We also look forward to the clinical data update for adagrasis in combination with primblizumab in the first line KRAS G12C mutated non-small cell lung cancer in the second half of 2023.
Joshua L. Smiley: I'd like to emphasize the advancement of these potential treatments for lung and gastric cancers continue to add design in these areas of large unmet need. We will continue to invest in R&D and advance our internal global. In terms of key research milestones, we plan to move ZL-1102 for potential in chronic plaque psoriasis into full global development with the initiation of a global phase two study in 2022. We also plan to initiate a global phase one study for ZL 1218 or CCR8 in the first half. Of course, we also continue to evaluate business development, including the addition of potentially transformative opportunities and partnerships for our regional and global businesses. Xilab is a trusted brand and strategic partner of choice, and we look forward to entering into more deals that we believe will create significant value and synergies for our existing business.
Speaker 6: In terms of clinical developments, we will complete the enrollment in the Global Phase 3 Innovative 301 Study of TIB-DAC in second and third line cervical cancer in the first half of 2023. We also plan to join the Global Phase 3 Fortitude 101 Study of bemrotuzumab in first line gastric cancer in China in mid-2023.
Speaker 6: And we anticipate initiating a bridging study of CAR-XT for schizophrenia in China in mid-2023. I'd like to emphasize the advancement of these potential treatments for lung and gastric cancers continues to add desired strength in these areas of large unmet patient need.
Speaker 6: We will continue to invest in R&D and advance our internal global pipeline. In terms of key research milestones, we plan to move ZL1102 for potential in chronic plaque psoriasis into full global development with the initiation of a global Phase II study in 2023. We also plan to initiate a global Phase I study for ZL1102.
Joshua L. Smiley: Before I conclude, I'd like to welcome Dr. Raphael Amato to his first earnings call. Raphael will make introductory remarks before discussing advances with respect to oncology, and now I'll turn the call over to Dr. Amato.
Speaker 6: 1218 or CCR8 in the first half of 2023. Of course, we also continue to evaluate business development opportunities.
Speaker 6: including the addition of potentially transformative opportunities and partnerships for our regional and global pipeline. ZyLab is a trusted brand and strategic partner of choice, and we look forward to entering into more deals that we believe will create significant value and synergies to our existing business. Before I conclude, I'd like to welcome Dr. Rocky Elimado.
Rafael G. Amado: Thank you, Josh. I'm thrilled to be joining Zai Lab at such a pivotal time in the company's history. As a physician scientist, I've had the privilege to work on the development and approval of cancer therapies across various modalities and to form and lead R&D genes. Zai has a broad portfolio of innovative products, state-of-the-art capabilities for development in greater China, and the ambition to continue to globalize research and development in oncology. The combination of products with transformational potential, excellence in execution, together with the ambition for global expansion, makes ZyLab an easy choice as the next step in my career.
Speaker 7: is right now, but just this was all time in the company's history.
Speaker 7: As a physician scientist, I've had the privilege to work on the development on approval of cancer therapies across various modalities and to form and lead R and D.
Rafael G. Amado: I look forward to working with outstanding colleagues to continue to build capabilities and to help catalyze the expansion of our oncology pipeline. In the fourth quarter of 2012, Dry Labs' oncology franchise continued to make progress on all fronts, and we expect to have a productive year in 2023. For tumor-feeding fields, in January 2023, Zylaab and Nobuquer announced that the Lunar study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone.
Speaker 7: Xi has a broad portfolio of innovative products, state-of-the-art capabilities for development in Greater China, and the ambition to continue to globalize research and development in oncology.
Speaker 7: The combination of products with transformational potential, excellence in execution, together with the ambition for global expansion, makes SciLab an easy choice as a next step in my career.
Speaker 7: I look forward to working with outstanding colleagues to continue to build capabilities and to help catalyze the expansion of our oncology pipeline. In the fourth quarter of 2022, dry lab oncology franchise continues to make progress on all fronts, and we expect to have a productive year in 2023.
Rafael G. Amado: The lunar study also showed statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTCOs and immune checkpoint inhibitors as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with Tiki Fields and Dositactyl versus Dositactyl alone. Dici Shield Therapy was well tolerated by patients enrolled in the experimental arms of the study. We are excited about the potential of TP fields to help lung cancer patients. In China alone, lung cancer is the most common cancer type, with approximately 700,000 new cancers diagnosed each year.
Speaker 7: For tumor-feeding fields, in January 2023, Zilab and NovoCure announced that the lunar study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone.
The lunar study also showed statistically significant and clinically meaningful improvement in overall survival when patients were treated with TPCL and immune checkpoint inhibitors as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with TPCL and docetaxel versus docetaxel alone. TPCL therapy was well tolerated with...
Rafael G. Amado: We are pleased to contribute to and be a part of the lunar study. Because Lunar met its primary endpoints of overall survival, we're optimistic about its broad potential across a range of hard-to-treat and prevalent cancers. The next stage studies underway in certain other cancer types include pancreatic, where Zay is actively enrolling patients. Moving now to Grazadi or Aragratia, it was granted accelerated approval by the FDA in December 2020 for adult patients with KVAS G2C mutated locally advanced or metastatic non-smoke cell lung cancer who had received at least one prior systemic therapy.
patients enroll in the experimental arms of the study. We are excited about the potential of CT fields to help lung cancer patients. In China alone, lung cancer is the most common cancer type with approximately 700,000 new cancers diagnosed each year. We are pleased to contribute and to be a part of a lunar study.
Moving now to Grazadi or Aragratia, it was granted a similar approval by the FDA in December 2022 for adult patients with K-RAS-T-TWC-imitated locally advanced or metastatic non-smoked lung cancer, who had received at least one prior systemic therapy. In China, we will continue to accelerate the regulatory pathway for second-line non-smoked lung cancer-mountain cancer.
Rafael G. Amado: In China, we will continue to accelerate the regulatory pathway for second-line non-smol cell lung cancer monotherapy by leveraging the global data package for the FDA approval, the ongoing TK study in China, and the global confirmatory crystal 12 study, which my lab joined in July 2022. Further, in December 2022, the FDA granted breakthrough therapy designation to add aggressive in combination with the toxinum in patients with CARES G12c mutated advanced colorectal cancer whose cancer has progressed following prior treatment with chemotherapy and an anti-vedged therapy with results published in the New England Journal of Medicine. Aradrassis demonstrated anti-dumer activity in heavily-priterated patients with K-RAS G20C, metastatic CRC, both as monotherapy and in combination with detoxim.
to add aggressive incommination with the ductumab in patients with K-RS G-12T mutated at Downscalorectal Cancer, whose cancer have progressed following prior treatment with chemotherapy and an anti-vegis carapy with the results published in the New England Journal of Medicine. Other grasses demonstrated anti-dumarab curing heavily protruded patients.
Rafael G. Amado: Murabi plans to submit the new supplemental drug application in third line plus K-RAS G2C mutator advanced CRC by year end, 2023, and move forward with the accelerated approval path. Zai initiated enrollment in the randomized crystal 10th study in second line metastatic TLC in June 2022, and enrollment completion is expected by the end of 2023. We remain confident that at a grass-root level, it is potentially a best-in-class KRA's T2LC inhibitor in colorectal cancer.
advanced ERC to Quaid Year in 2023 and move forward with accelerated approval pathway.
Zai initiated an involvement to the randomized crystal-10 study in several line-medestatic QSP in June 2022, and the enrolling completion is expected by the end of 2023.
We remain confident that at a graph, it is potentially a best-in-class K-RAS casual C inhibitor incontzial soprata.
Rafael G. Amado: For first-line non-smussen lung cancer, recall that in December 2020, Muradi reported results in the Crystal 7-Pase 2 trial and Crystal 1-Pase 1B cohort evaluating at a grass in combination with Sembriliguma in patients for the treatment of first-line non-smol cell lung cancer harboring KRAs T2-SC mutations across all PDL-1 subgroups. We are excited that these results are the first to demonstrate the tolerability and feasibility of a concurrent combination regimen of a K-Rast JLC inhibitor and a PD1, PDL1 checkpoint inhibitor.
For first line, Nonsmosa lung cancer recalls that in December 2022, Murati reported results from the crystal-7-paste-2 trial and crystal-1-paste-1B cohort evaluating other breastfeeding combination with femoralidema, in patients for the treatment for first line, Nonsmosa lung cancer, covering K-RASP to excretation across all PDL-1 subgroups.
We are excited that this results out of the first to demonstrate the polar ability and sensibility of a concurrent combination regiment of a K-RAS to Joe C. inhibitor and a PZ1, PZL1 tick-point inhibitor. And we will continue to work with Mirati on a first-line registration plan for Roberto Gra c?? launch.
Rafael G. Amado: And we will continue to work with Miradi on a first-line registration plan for other grabs. Moving now to Cigula, we were pleased that NMPA granted full approval to the first-line ovarian cancer maintenance indication on February 3rd, 2023, regardless of biomarker status. In December 2022, we presented new interim overall survival data in Chinese patients with platinum-sensitive recurrent ovarian cancer from the Phase 3 Nora study conducted exclusively by XILA at the ESMO virtual plenary session. Median overall survival was numerically longer for patients receiving Cigula, regardless of biomarker status, at 46.3 months compared to 43.4 months in the placebo group. No new safety issues were identified.
We announced this year that we were pleased that NMPA granted full approval to the first-line ovarian cancer maintenance indication on February 3, 2023, regardless of biomarker status.
In December 2022, we presented new interim overall survival data in Chinese patients with pardonable sensitive recurrent ovarian cancer from the Phase III noris study conducted exclusively by Zayla.
In December 2022, we presented new interim overall survival data in Chinese patients with partner and sensitive recurrent ovarian cancer from the Phase III noras study conducted exclusively by Zyla at the ESMO virtual plenary session.
Medium of rural survival was numerically longer for patients receiving to July regardless of biomarker status at 46.3 months compared to 43.4 months in the placebo group.
Rafael G. Amado: We expect to present the final OS analysis of the phase three Nora study sometime this year. Now, I'm moving now to our internal global research and development programs; translational and clinical biomarker data for ZL-1211 and anti-clotin 18.2 antibody will be presented in a poster at an upcoming AACI conference. And we plan to initiate a global phase one study in the first half of 2023 for CL1218; it's an anti-CCR8 antibody. With an abundance of potentially best in class and first in class products, we're very excited about our oncology pipeline and dry lab.
No news safety issues were identified. We expect to present the final OS analysis of the Phase 3 nor study sometime this year.
A moving now to internal global research and development programs is translational and clinical biomarker data for VL1211 and anti-clotting 18.2 antibody, where we present it in a poster at a upcoming ASCI conference. And we plan to initiate a global phase 1 study in the first half of the session.
Rafael G. Amado: And now I will turn the floor over to Dr. Harald Reinhardt to discuss the progress in our autoimmune infectious disease and neuroscience therapeutic areas. Thank you, Raphael. I'm excited for the opportunity to share with you today the progress across our autoimmune infectious disease and neuroscience therapeutic areas. Let's start with this guide for FKechima.
we will turn the floor over to Dr. Harold Reinhart to discuss the progress in our autoimmune infectious disease and neuroscience therapeutic areas. Harold?
Thank you, Raphael. I'm excited for the opportunity to share with you today the progress across our autoimmune infectious disease and neuroscience therapeutic areas. Let's start with Livgard or F-Gartegemann. On the regulatory front, we and our partner, Argenix, continue to make excellent progress.
Harald Reinhart: On the regulatory front, we and our partner Genics continue to make excellent progress. Igenics recently announced that the FDA has accepted for priority review a BLA for EFGA Teaching Mod SubQ for the treatment of adult patients with generalized myisemia gravis. The Bedoufa date is June 20th, 2023. As a reminder, we submitted the BLA for FGMOT IV for the treatment of patients with GMG in China in the second quarter of 2022, and we expect approval and commercial launch this year.
iGenics recently announced that the FDA has accepted for priority review a BLA for F-Gard teaching mod sub q for the treatment of adult patients with generalized myasthenia gravis.
The B258 is June 20th, 2023. As a reminder, we submitted the BLA for FKTGMOT IV for the General Patients with GNG in China in the sector quarter of 2022.
Harald Reinhart: You also expect to submit a BLA for FGat in the HMOT sub queue for GMG in mid-20203. We continue to support IGENICs in indication expansion, China and worldwide. Indeed, enrollment in two proof-of-concept trials for autoimmune renal diseases has begun this February. Moving on to CARXT, the combination of xenomalin androspium, which we are developing with our partner Corona in acute schizophrenia.
and expect approval and commercial launch this year. You also expect to submit a BLA for FGH-MOD sub-queue for GMG in mid-2023.
We continue to support hygienics on indication expansion China and worldwide Indeed enrollment in two proof of concept trials for autoimmune riddle diseases has begun this February .
Moving on to CAR XT, the combination of tenomoline and traspium, which we are developing with our partner Karuna in acute schizophrenia.
Harald Reinhart: Zylaabs proposed development plan for China has been accepted by the NNPA, and we expect to start a clinical bridging study in mid-20203. As you recall, results from Karunas' emerging two trial were released in August 2022. This pivotal trial met its primary endpoint, with CAR-XT demonstrating a statistically significant 9.6 point reduction in PAN's total score compared to placebo at week five.
ZILAV's proposed development plan for China has been accepted by the NMPA and we expect to start a clinical bridging study in mid-2023.
As you recall, results from coronavirus emergency tube trial were released in August 2022. This pivotal trial made its primary endpoint with CARXT demonstrating a statistically significant 9.6-point reduction in PAN's total score compared to placebo at week 5.
Harald Reinhart: In addition, Corona expects top-line data results from the phase three immersion three trial in schizophrenia in the first quarter of 2023 and an NDA submission to the FDA for CARXD in schizophrenia in mid-2020. Regarding our infectious diseases portfolio, we have several noteworthy developments. For Sulbactam Duralabakam, or Suldur, we submitted the NDA for the treatment of carbapenem-resistant, Athenibacter Bamani We were granted priority review one month later in January 2023, and in February, the NDA was officially accepted by the NMPA. We look forward to bringing this novel drug to China and Asia Pacific, where severe crab infections are frequent.
In addition, Corona expects top-line data results from the Phase 3 Immersion 3 trial in Schizophrenia in 1st quarter of 2023, and an NDA submission to the FDA for CARICS in Schizophrenia in March 2023.
Regarding our infectious disease portfolio, they have several North-Worthy development.
For a soon-backed endurole of acta-am or soledure, we submitted the NDA for the treatment of carbopenemoresistence passes the back to Bamanee infection to the NMPA in December 2022. We will grant its priori to review one month later in January 2023.
And in February , the NDA was officially accepted by the NMPA. We look forward to bringing this novel drug to China and Asia-Pacific, where severe crab infections are frequent and often can no longer be adequately treated because of Much through resistance.
Harald Reinhart: It often can no longer be adequately represented because of multi-representation. For Omada cycling, Nusaira, as Samantha mentioned earlier, we are happy to report that it was successfully listed in China's NRDL as of January 2023. And lastly, our internally developed topical I-17 product, CL1102, continues to progress towards initiation of a phase two study for chronic plaques arises in later 2023. And now, Billy will speak about progress with our commercial products and financial results. Thank you, Harold.
For our mother, Saiklin, Musaira, as Samantha mentioned earlier, we are happy to report that it was successfully listed in China's NRDL as of January 2023.
And lastly, our internally developed topical IL-17 product, CL-1102, continues to progress towards initiation of a Phase II study for chronic plaque services in later 2020-23.
And now we will speak about projects with our commercial products and financial results, Billy. Thank you, Harold. Our former market of products, Zedula, Optune, Kinlock, and Zara, continue to achieve solid revenue growth, driven by strong demand and commercial execution. Thank you.
Billy: Our foreign market of products, Zidula, Optun, Kinloch, and Izira, continue to achieve solid revenue growth driven by strong demand and commercial execution. The Jula continued to perform well and increase its share of PARP sales for varying cancer during the fourth quarter to Dunveh. We expected Julio to become the sales leader in China this year.
The Julea continues to perform well and increase the share of park sales for varying cancer during the fourth quarter to 12.2. We expect the Julea to become the sales leader in China this year. For our tune, we are starting to see a strong recovery given the COVID situation throughout last year, achieving solid revenue growth in the fourth quarter.
Billy: For Optune, we are starting to see a strong recovery given the COVID situation throughout last year, achieving solid revenue growth in the fourth quarter. During 2022, our team focused on continuing to improve market access by expanding commercial and supplemental insurance coverage for often in educating physicians about its potentially significant clinical benefits, including survival. As of December 31st, 2022, Optin was covered by 87 municipal or provincial supplemental insurance, up from 33 such plans for the prior year. We're pleased to have added Kinloch and Uzara to China's national reimbursement drug list in January, 2003.
During 2002, our keen focus on continuing to improve market access by expanding commercial and supplemental insurance coverage for opt-in and educating positions about its potential significant clinical benefits including survival. As of December 31, 2022, opt-in was covered by 87 municipal or provincial supplemental insurance grants, up from 33 such plans a part of the year. We're pleased to have added Ken Lock and Zara to Thomas National Embracement's drug list in January 2023.
Billy: And implementation starts this. As discussed earlier, we expect a strong revenue ramp-up for these products as a result of their NRD inclusion. For F-Gar Kijamod, the first and only US-approved FCRN blocker with a pipeline and product potential, we're getting ready for the commercial launch later this year. We plan to have a specialized and experienced team for F-Car with about 100 employees at. We are quite excited about its block puzzle
and implementation starts this month. As discussed earlier, we expect strong revenue ramp up for these products as a result of their NRD inclusion. For F-Cartigimod, the first and only US approved F-ERN blocker with pipelining and product potential, we're getting ready for the commercial launch later this year.
We plan to have specialized and experienced team for F-CAR with about a hundred employees at launch.
Billy: Now I will discuss our full year and fourth quarter of 2022 financial results compared to the prior year period. Total revenues for the full year of 2022 were $215 million, compared to $144.3 million in 2021, representing a 49% year-over-year growth. Total revenues for the fourth quarter were $1.22.6 million compared to $44.2 million in the prior year, representing a 41.7 percent year-over-year growth.
We are quite excited about its blockbuster potential in China. Now I will discuss our full year and fourth quarter of 2022 financial results compared to the prior year period. Total revenues for the full year of 2022 were $215 million compared to $144.3 million to $21.2 million.
representing a 49% year-over-year group.
Total revenues for the fourth quarter of 1222 were $62.6 million compared to $44.2 million in the prior year representing a 41.7% year-to-year growth. Part of revenues for the full year of 2022 were $145.2 million for the Gula.
Billy: Product revenues for the full year of 2022 were $145.2 million for Zidula, compared to $93.6 million in 2012, representing a 55.2% year-over-year growth. 47.3 million dollars for optune compared to 38.9 million dollars for 2021, a 21.6 year-over-year growth, and $15 million for Kinlock compared to $11.6 million in 2012, a 28.7% year-over-year growth, and $ R&D expenses were $286.4 million in 2022, compared to $573.3 million for the same period in 2021. The decreasing R&D expenses in 2002 were primarily due to lower upfront payments for new licensing agreements.
compared to $93.6 million in 2021, representing a 55.2% year-over-year growth. $47.3 million for option compared to $38.9 million for 2021, a 21.6% year-over-year growth, and $15 million for Kinlock compared to $11.6 million in 2021, a 28.7% year-over-year growth, and $5.2 million for Desire of.
compared to close to zero in 2021. R&D expenses were $286.4 million for 2022, compared to $573.3 million for the same period in 2021. The decreasing R&D expenses in 2022 was primarily due to lower upfront payments for new licensing agreements.
Billy: Exclusivity upfront payments for new licensing agreements, R&D expenses worth $256.4 million in 2012 compared to $252 million in 2021. SGNA expenses were $259 million in 2002 compared to $218.8 million for the same period in 2012. The increase was primarily due to higher payroll and payroll-related expenses from the increased headcount, as Dialap continued to expand and invest in its commercial operations in China and infrastructure in the United States in anticipation of substantial growth over the next few years.
Discruing upfront payments for new life-and-conquering payments are in the expenses worth $256.4 million at the 2012-222 compared to $252 million in 2021. S&A expenses were $259 million for 2012-222 compared to $218 million for the same period in 2021.
The increase was primarily due to higher payroll and payroll related expenses from the increased headcount, as Zayla continued to expand and invest in its commercial operations in China and infrastructure in the United States in anticipation of substantial growth over the next few years. Zayla reported a net loss of $443.3 million, where he lost per share attributable.
Billy: Dialab reported a net loss of $443.3 million, or a loss per share attributable to common stockholders of 46, for 2012, compared to a net loss of $704.5 million, or a loss per share attributable to common stockholders of 76, for 2021. The decrease in the net loss was primarily due to lower payments related to new business development activities and continued growth in product sales.
the common stockholders of 46 cents for 2022 compared to a net loss of $700, $4.5 million or a loss per share attributable to common stockholders of 76 cents for 2021. The decrease in the net loss was primarily trivial to lower payments related to new business development activities and continued growth in product sales.
Operator: As of December 31st, 2022, cash and cash equivalents, short-term investments, and restricted cash totaled $1 billion, compared to $1.4 billion as of December 31st, 2021. We would now like to turn the call back over to the operator to open the line for questions. Operator. Ladies and gentlemen, we now begin the question and answer session. If you wish to ask a question, please press 1-1 on your telephone. Please keep your question to a maximum of 2, then press 1-1 to ask a question. We are now taking the first question. Please stand by. The first question from Michael He from Jeffries. Please go ahead.
As of December 31, 2022, cash and cash equivalent short to an investment and restrict the cash total $1 billion, compared to $1.4 billion as of December 31, 2021.
We would now like to turn the call back over to the operator to open the line for questions. Operator? Ladies and gentlemen, we now begin the question and answer session. If you wish to ask a question, please press star 11 on your telephone. Please keep your question to maximum of two.
Start one one to ask a question. We are now taking the first question. Please stand by. The first question from Michael H. from Jeffries. Please go ahead. Hey guys, thanks and good morning from our side.
Michael Jonathan Yee: Hey guys, thanks, and good morning from our side. We had two questions. One was, maybe you could just give us sort of a real-time update on how things are going in China as regards opening up as COVID evolves there, both from a commercial execution standpoint, but also from a clinical trial execution standpoint for all the partners. How is that progressing sort of relative to pre-COVID?
We had two questions. One was maybe you could just give us sort of a real time update with how things are going in China as opposed as regards to opening up as COVID evolves there, both from a commercial execution standpoint, but also from a clinical trial execution standpoint for all the partners.
Unknown Executive: And then second, obviously, with TTF and lung cancer, that was a big announcement recently appreciating that that needs to probably get filed first, et cetera. How are you thinking about that launch and opportunity relative to GBM and, particularly, on the reimbursement side? Thank you.
How is that progressing relative to pre-COVID? And then second is obviously with TTF and lung cancer that was big. Announcement recently, appreciating that that needs to probably get filed first, et cetera. How are you thinking about that launch and opportunity relative to GBA?
Unknown Executive: Hey, thanks, Mike, for your questions. Maybe I'll get started, and other colleagues can chime in. So some on-the-ground reporting from COVID kind of opening. I think everyone is quite familiar with the challenges that everyone faced in 2022 and the impact, of course, even all the way through the end of 22, as well as early this year. We're clearly monitoring the situation very closely and will continue to do that, but so far, so good.
and particularly on the reimbursement side, how to think about that opportunity. Thank you. Hey, thanks, Mike, for your questions. Maybe I'll get started and other colleagues can chime in. So on the ground reporting from COVID kind of opening, I think everyone is quite familiar with the challenges that everyone faced in 2022. And the impact, of course, even all the way through end of 2022, as well as early this year, we're clearly monitoring the situation very closely and we'll continue to do that. But so far so good. And it looks like.
Unknown Executive: And it looks like, you know, as we kind of enter right now in March and wrap up the first quarter, it looks like we're being optimistic going into the spring and beyond and getting back into some semblance of normalcy. So pretty, pretty energized.
As we enter right now in March and wrapping up the first quarter, it looks like we're being optimistic going into the spring and beyond, and getting back into some semblance of normalcy. So pretty energized. If you are here and I'm in Shanghai right now, the activity is quite active and buzzing, so it's great to see that. Traffic, not so much. But refused.
Unknown Executive: And if you are here, and I'm in Shanghai right now, the activity is quite active and buzzing. So it's great to see that traffic, not so much. But on the commercial side and the R&D side, on the R&D piece, I think we've really learned that our team in the clinical development and clinical operations team has done a terrific job of navigating the challenges with COVID in the past. And you've seen us consistently execute and have a very resilient performance and not slipping up in any of our commitments to the patients, to the physician community, to our partners, et ceter
For the on the commercial side and the R&D side on the R&D piece I think we really learned we are keen in in the clinical development clinical Obstin has done a terrific job of navigating the challenges with COVID in the past and you've seen us consistently execute and have a very resilient performance and not slipping up in any of our commitments to the patients to the physician community. To the physician community.
Unknown Executive: So, you know, I think for us, we had, we managed it quite smoothly, so I'm quite proud of that, as well as for commercial, and you would have seen, you know, consistent growth. You know, I think the fourth quarter came in, given what happened, you know, even through the end of December and parts of early this year. You know, I think, relatively speaking, quite happy with the outcome.
Unknown Executive: And looking forward to, you know, a more normal environment. So we expect 2023 to be a strong year for growth. On the tumor-treating fields, I think your question was really more about the commercial opportunity part and the reimbursement part. So you've probably heard us say before that an NRDL, a national reimbursement policy for a technology like tumor-treating fields, we think that there's a possibility if it could be formalized, you know, as early as this year.
and quite happy with the outcome and looking forward to a more and more environment. So we expect 2023 to be a stronger for growth.
On the tumulturing field, I think your question was really more towards the commercial opportunity part and reimbursement part. So you've probably heard us say before that, like NRDL, a national reimbursement policy for a technology like tumulturing field, we...
Unknown Executive: So we'll all sort of be on standby for that, and if we hear something, we'll kind of upstream to everybody else. And the significance of, I mean, it's subject to data, of course, for the lunar, but the opportunity is quite significant. I think Raphael said that there are, and people know there are 700,000 new cases per year for non-stable lung cancer, half of whom are going to be in stage four, and about 30% in stage three. And despite treatment options available, the significant medical need, and that type of quantum number is pretty dire.
think that there's a possibility it could be formalized as early as this year. So we'll all be on standby for that and if we hear something we'll upstream to everybody else. And the significance of, I mean, this subject to that of course for lunar, but the opportunity is quite significant. I think Rafael said that there's, and people know there's 700,000 new cases per year for non-smotelon cancer, half of whom are going to be in stage four.
and about 30% in stage three. And despite treatment options available with the significant medical need, and at that type of quantum number is pretty dire. So again, subject to the data that should be coming out sometime this year, the opportunity is quite significant and it could be a blockbuster program opportunity for us. Good, thank you. Thank you for your question.
Unknown Executive: So, again, subject to the data that should be coming out sometime this year, the opportunity is quite significant, and it could be a blockbuster program opportunity for us. Good. Thank you for your question. We are now taking the next question. Please stand by.
We are now taking the next question. Please stand by. The next question from Anupam Irama from JP Morgan. Please go ahead. Your line is open. Hey guys, thanks so much for taking the question. Maybe a broader question actually. You guys have talked a lot about private pay and supplemental insurance. What portion of revenues are currently reimbursed with this mechanism? And what does that look like as you model out to 2025 and 2022?
Anupam Rama: The next question is from Anupam Rama from JPM. Please go ahead. Your line is open. Hey guys, thanks so much for taking the question. Maybe a broader question, actually. You guys have talked a lot about private pay and supplemental insurance. What portion of revenues are currently reimbursed through this mechanism, and what does that look like as you model out to 2025 and the 2020-30 timeframe? And which products do you see with the greatest portion being reimbursed by private pay and supplemental insurance? Thanks so much. And apombe, Josh, do you want to take this one?
Joshua L. Smiley: Sure. Hi Annapalm, thanks for the question. I'd say first, you know, we're pleased with the overall reimbursement environment in China and its development over the last few years. Certainly on the supplemental insurance side, we have a number of people covered growing from about 40 million at the end of 2020 to 150 million at the end of 2022. We expect that number to grow over the next few years to, you know, somewhere between 200 and 300 million. So, a quite sizable population if you start to look at that compared to other, you know, countries around the world.
being a number of people covered grow from about 40 million at the end of 2020 to 150 million at the end of 2022. We expect that number to grow over the next few years to somewhere between 200 and 300 million. So quite sizable population if you start to look at that compared to other.
Joshua L. Smiley: So that's certainly positive. And we see the benefits of that, you know, most directly now in office. You know, so in terms of percentages, while we don't break it out, you know, I think just looking at our results. Zajula is covered through NRDL; the other three products weren't.
countries around the world. So that's certainly positive and we see the benefits of that, you know, most directly now in, in optude. You know, so in terms of percentages, while we don't break it out, you know, I think just looking at our 2022 results, Zajula is covered through NRDL, the other three products weren't. So just at a very macro level.
Joshua L. Smiley: So just at a very macro level, you know, about 70% or so of our sales were through some NRDL mechanism, the rest through a combination of, you know, commercial, supplemental insurance, and private pay. I think as we look forward, though, certainly with the growth in supplemental insurance, that provides a really important option at launch for our innovative products for a sizable number of patients to have access to the innovation and for physicians to gain experience.
you know, about 70% or so of our sales were through some NRDL mechanism, the rest through combination of commercial supplemental insurance and private pay. I think as we look forward, though, certainly with the growth in supplemental insurance, that provides a really important option at launch for our innovative products for resizable.
Joshua L. Smiley: But our strategies going forward for the kind of drugs that we are developing either in our internal pipeline or with partners, we think they are ultimately going to be NRDL opportunities, and Billy alluded earlier that even on the medical device side, we see some really, you know, important progress there. So I think, Annaplom, really, our strategy is to bring great innovation as it relates to China, great innovation to Chinese patients, and we want to do that as broadly as possible.
Opportunities and Billy alluded earlier that even on the medical device side, we see some really important progress there. So I think really our strategy is to bring great innovation as it relates to China. Great innovation to Chinese patients. And we want to do that as broadly as possible. So our lead strategy will be to leverage NRDL.
Joshua L. Smiley: So our lead strategy will be to leverage NRDL opportunities. We're quite pleased with the three products we now have on NRDL and the economics associated with them. In other words, the net price we now have relative to patient opportunities, we'll continue to pursue that for innovative drugs like F-GARTIGAMOD, but certainly, the multi-layered system now in China developing in a robust way provides a lot more flexibility and a lot more options for early access for some sizable amounts of patients. Thanks for the question. Thanks so much.
opportunities. We're quite pleased with the three products we now have on an LDL and the economics associated with them. In other words, the net price we now have relative to the patient opportunities will continue to pursue that for innovative drugs like Epcot Digimon this year, but certainly the the multi-layered system we're seeing now in China.
develop in a robust way, provides a lot more flexibility and a lot more options for early access for some sizeable amount of patients over time. Thanks for the question. Thanks so much. Thank you for your question. We are now taking the next question.
Operator: Thank you for your question. We are now taking the next question. The next question is from Yergal Notchomovitz from Citi.
Yigal Dov Nochomovitz: Let's go ahead. Your line is open. Hi, thank you for such a good question. Billy, I think you said that you're basically flat year-on-year on R&D, XP up front, and maybe marginally higher year-on-year-on-year on SGN. Just, if you could just clarify, is this spend basically going to be flatish going forward to drive to overall corporate profitability with top line growth by the year in 25, or might you have some flexibility to accelerate OPEX and still navigate to profitability with the top line broke by the end of 25. Yeah, here you go. So you're right. You heard that correctly.
The next question for Yiga and Nacho Mollitz from City. Let's go ahead. Here I am, he's open. Hi, thank you for taking the question. Billy, I think you said that you're basically flat year on year on R&D, at the upfront, and maybe marginally higher year on year on, on a street and just if you can just clarify, is this spend basically going to be flatish going forward to drive to overall corporate profitability with the top line growth by the year year and 25 or
might you have some flexibility to accelerate up at we still navigate to profitability with the top line growth by the end of 25. Yeah, here you go. So you're right, you heard that correctly. In terms of core R&D, it was pretty much at the 250 level, so roughly flat year by year, 2021-22. This year, you can expect a very modest increase. And as you know, we have a pretty active...
Billy: In terms of core R&D, it was pretty much at the 250 level, so roughly flat year after year, 21, 22. This year, you can expect a very modest increase. And as you know, we have a pretty active development calendar given the anticipated approvals and launches over the next two, three years. I think we have around eight, at least in the queue. So, but I think you should expect that to be at that range.
development calendar given the anticipated approval to launch over the next two three years I think we have around eight at least in the queue so but I think you should expect our two BF that range
Billy: Now for SG&A, so we have, the S portion, you know, we have said that this year we're going to be commercially profitable, or we target to be commercially profitable even as we build a new sales team for FGARC-Catjeama launch. So that's a great place to be. You can expect to see operating leverage continue to increase as revenue increases and as we launch additional products. And so there is, you know, a lot of flexibility that we have, and that's, I think, you know, kind of a great place to be.
Now, for S-GNA, so we have, so it's an S-portion, you know, we have said that this year we're going to be commercially profitable or we target to be commercially profitable even as we build a, you know, a new sales team for F-Gartism on launch. So at the great place to be, you can expect to see that, you know, offering leverage continued to increase.
as the revenue increases and as we launch additional products. And so there is...
Billy: You know, when you have kind of a growing and relevant scale, a strong balance sheet, and sort of all the engines are firing on all cylinders, you can establish a good baseline and preserve some optionality. Hey, Bill, I'll just maybe add just one quick point to that, which is, really, our priorities are to grow the top line and to advance our clinical programs, and we've got, you know, a plethora of them.
a lot of flexibility that we have. And that's I think a great place to be. When you have a growing and relevant scale, a strong balance sheet, and all the engines are firing on all cylinders, you can establish a good baseline and preserve some optionality.
I just maybe add just one quick point to that is you know really our priority is our growth the top line and to advance our clinical programs and we've got a placer of them. But if we execute on those two priorities you go on.
Billy: But if we execute on those two priorities, you know, the profitability is going to follow. So, you know, if you look at products like Jula and our women's health franchise and the expected growth over the next few years and then add TivDAC on top of that, those are the things that are going to drive profitability and give us the flexibility, as Billy mentioned, to continue to invest in, you know, Salesforce to continue to invest in the clinical program. So again, to us, it's more around the portfolio that we built. If we execute as we expect, to along that side, the profit vote. And just real fast, just one housekeeping on Quinlock and Nizura.
the profitability is going to fall. So, you know, if you look at products like the Julea and our women's health franchise, and the expected growth over the next few years, and then add TIB DAC on top of that, those are the things that are going to drive profitability and give us the flexibility of belly-billy mentioned to continue to invest in sales force, to continue to invest in the clinical program. So, again, to us.
Yigal Dov Nochomovitz: So can you say at this point what the discount is for the NRDL? I think you mentioned the press release. We expect a significant increase just trying to, just for our modeling purposes, what does that look like? Yeah, so the Nardale pricing for Kinlock is $2,400 a month. And then for Newzira, it's $450 a month.
what does that look like? Thanks.
Yeah, so the the the NRD pricing for Kinlock is $2,400 a month and then for Nizara it's $450 a month.
Billy: Oh, sorry, for Nizara, it would be for the treatment, $450 million, $450 a month for the treatment cost. Okay, great. All right. Yeah.
Oh, sorry. The $450 million for the treatment cost.
Oh, sorry, 4 New Zara OB for the treatment, the $450 million for the treatment cost.
Operator: Thank you for your question. We are now taking the next question, you stand by. The next question is from Jonathan Chang from SVB Securities. Please go ahead. Your line is open.
Thank you for your question. We are now taking the next question.
Please stand by. The next question from Jonathan Chang from SVB Securities. Please go ahead. Here, let me open. Hi guys, thanks for taking my questions. First question, just to – can you elaborate more on the assumptions underlying your guidance of achieving corporate profitability by end of 2025 and discuss your level of confidence in this?
Jonathan J. Wang: Hi guys, thanks for taking my questions. First question, just to clarify the assumptions underlying your guidance of achieving corporate profitability by the end of 2025 and discuss your level of confidence in this? And then, second question: can you discuss XILAB's current state of compliance with the HFCAA and how you're thinking about the situation going forward? Yeah, thanks, Jonathan. So I could take these. And maybe I'll start with the second one.
And then second question, can you discuss ZILAB's current state of compliance with the HFCA and how you're thinking about the situation going forward? Yeah, thanks, Jonathan. So I'll take these two. And maybe I'll start with the second one. That's going to be a quick point that I want to...
Billy: That's got to be a quick, quick point that I want to, or can make. So you would have seen that our 10K that we just filed is with KPMG US. And that means that we have findings that are fully accessible by the PCO. And as a result, we have and continue to believe that we are now fully compliant with all the requirements of the HFCAA. And that's going to preclude us from being on any kind of list or any kind of potential for delisting from the NASDAQ.
So you would have seen that our 10K that we just filed is with KPMG US. And that means that we have five things that are fully accessible by the PCOB. And as a result, we have and continue to believe that we are now fully compliant with all the requirements of the HFCA.
And that's going to preclude us from now and future to be all sort of any kind of list or any kind of potential for delisting from the NASDAQ. So very proud of the team that worked hard to get this done and it was strategically very important for us. So I think again, a little kudos to the team and welcoming KPMG US on board.
Billy: So, very proud of the team that worked hard, you know, to get this done. And it was strategically very important for us. So I think, you know, again, a little kudos to the team and welcome KPMG US on board. So to your first question, on kind of how we feel about the statement that we made about getting to overall profitability by the end of the 25th, Jonathan, we wouldn't make such statements, you know, unless we carefully thought about them. So the best way to think about the, you know, we're not giving guidance at this time, so we're not going to kind of give you hard numbers.
So to your first question on how do you feel about the statement that we made about getting to an overall profitability by end of 25, John , that we wouldn't make such statements unless we carefully thought about it. So the best way to think about, we're not giving guidance at this time, so we're not going to give you hard numbers.
Billy: But if you took your, you know, the number that you had for 2025, whether you, Jonathan, or whether the street, and I know there's a range out there, but you take that and you assume, even if you assume just today's gross profit. And you know that's going to continue to improve over, you know, the next several years, but you, you know, use that. And then you kind of stick with sort of the modest assumptions on sales, marketing, and GNA, especially since we would have already done a lot of heavy lifting in infrastructure spending by then.
But if you took your, you know, the number that you had for 2025, whether you, Jonathan, or whether the street, and I know there's a range out there, but you take that and you assume, even if you assume just today's gross profit. And you know, that's going to continue to improve over, you know, kind of next several years, but you, you know, use that.
And then you kind of stick with sort of the modest assumptions on sales marketing and GNA, especially since we've already done a lot of heavy lifting infrastructure spend by then. And you...
You kind of stick with sort of the modus assumptions on sales marketing and GNA, especially since we've already done a lot of heavy lifting infrastructure spend by then. You will be able to get that.
Billy: We'll be able to get that. So I think you should, you know, we feel pretty good about it. And, you know, that gives us confidence to make, you know, a public comment about, Got it. Thank you. Thank you for your question.
So, I think we feel pretty good about it and that gives us the confidence to make a public Thank you for your question. We are now taking the next question. Please stand by. The next question from Zeechan from GS. Let's go ahead. Your line is open. Thank you. Thank you for taking my questions.
Operator: We are now taking the next question.
Zich: The next question is from Zich and from GS. Please go ahead. Your line is open.
Unknown Executive: Thank you. Thank you for taking the time to answer my questions. The first question is, you know, if we're looking at the commercial infrastructure, with more drugs expected to be launched in 2020 and next year, including Merger-Tick-Smap, Afgar, ripple, and more antibiotics. So the therapeutic category is becoming, you know, much bigger compared to what it is now. I'm trying to understand a bit more about your plan for the international commercialization team set up in order to achieve self-efficiency and, of course, maintain productivity when covering a variety of different therapeutic areas.
The first question is, you know, if we look at the commercial infrastructure, well, we see more drugs expected to be launched in 2023 and next year, including Margettook's map, FGAR, Red Pole, and more antibiotics. So the therapeutic category is becoming much bigger compared to what is now. I'm trying to understand a bit more about your plan and internship commercialization team set up in order to achieve the self-efficiency and of course, maintaining the productivity when covering a variety of different therapeutic areas. And secondly, you can certainly use sense of dimension about, you know, opt-in network.
Unknown Executive: And secondly, since you mentioned Optune, now we're going to look forward to the data. But could you elaborate a little bit more about, you know, based on the lunar data and what you're planning to communicate to CDE in China and what could potentially be the regulatory pathway and also timetable for the potential indication of approval in China? Thank you. Yeah, thank you.
Unknown Executive: And I'll give you a second question for Rafael. On your first question, as people who are familiar with the Xilab story know, we've been pretty thoughtful about curating a portfolio that's clustered around specific areas that are very strategic for us. And within that, some of the, they're all quite differentiated, and some of the programs are quite large in terms of commercial potential. So potential blockbusters, you know, would be the likes of, let's see, based on the data for Lunar, the tumor-treating Fields franchise, FEMA with Tizumab, and adagrassive as a pipeline program. I think that people are also underestimating and underappreciating drugs like CAR-XT, et cetera.
around specific areas that are very strategic for us. And within that, some of the, they're all quite differentiated, and some of the programs are quite large in terms of commercial potential. So, potential blockbusters would be the likes of, let's see, based on the data for lunar, the tumor treating fields franchise, B-Mortuzin-Map, and the adegressive at the pipeline to program.
Unknown Executive: So that's point one. Point two is it's actually a, you know, if you look at a snapshot of a quarter, two-quarter, three-quarter, you will not see it. see it, but if you look at what we have currently in the NDA submission, and you've already mentioned some of those, and you look at the programs that we have in the pivotal stage right now, there's also a lot of clustering effect going on. So for the women's cancer franchise that we've already built out with Jula, you threw out Margenza, but we have TivDak that Josh, you know, mentioned, and that is pretty substantial operating leverage that kicks in.
and you've already mentioned some of those. And you look at the programs that we have in pivotal stage right now. There's also a lot of clustering effect going on. So for women's cancer franchise that we've already built that with the Jula, you've threw out, you know, Marjena's up over here, TivTak, that Josh, you know, mentioned, and these are...
Unknown Executive: I believe that we have a slide in our corporate deck that says, here's a case study for Zijula, which is the first drug in the women's cancer franchise. You layer on top of that, and we're sort of expecting commercial profitability, you know, kind of profit margins for that product to be in the 40% range and even build upon from there. And then you look at the long programs in just the near-term stuff, and you've got, In addition to, of course, Lunar, which benefits from, of course, a specialized sales force for tumor tree fields in many ways. The lung itself would have, you know, a loop up to have Lunar, they have Chrysadi, you know, we've got the Ross 1 and probably missing a one and 2 more.
pretty substantial operating leverage that kicks in. I believe that we have a slide in our corporate deck that says, here's a case study for Zedula, which is the first drug in the Wemis Cancer franchise. You layer a tip back on top of that, and we're sort of expecting commercial profitability, kind of profit margins for that product to be in the 40% range, and even build upon from there.
And then you look at the long programs in just the near term stuff and you've got in addition to of course lunar which benefits from of course the specialized sales force for tumor tree fields and often anyways. The lung itself would have you know a on loop up to have lunar, they have prasadi, you know we've got the Ross one and probably missing one or two more.
Unknown Executive: And so we think that we have a lot of, you know, just a great opportunity here to drive productivity as we scale kind of revenue pretty much at the same time. Again, you will not see it in like, you know, from a quarter view, two quarter view from within a one to two year timeframe. You just, you know, really begin to see that. This is Raphael.
And so we think that we have a lot of, you know, just a great opportunity here to drive productivity as we scale kind of revenue pretty much at the same time. Again, you will not see it in like, you know, one quarter of you, two quarter of you from from within a one to two year time frame, you just, you know, really begin to see that. So this is rough, I'll just, please, just want to one or two I'll go over the second part of the question.
Unknown Executive: Yeah, I just wanted to go over the second part of the question. And, you know, just briefly, Novakir has made public that they expect to submit a PMA or remark approval application with the U.S. SDA, which by the end of the second half of TCR. That's the equivalent of the NDA for drugs.
Rafael G. Amado: So our plan is to fall on the heels of that submission and submit the MAA following the US submission in China. So, you know, the timing of that is still obviously flux as we work with our partner for the exact timing of the submission in the US, but it will follow very closely the US submission.
China. So you know the timing of that is still obviously a lot so if we work with our partner for the exact timing of the submission in the US but it will follow very closely the US submission and then obviously there's not a dual timeline in China but we will work with the authorities to
Rafael G. Amado: And then obviously, there's not a good timeline in China, but we will be able to do that timeline in China, but we will work with the authorities to try to, you know, accelerate the approval as soon as possible. So, you know, we expect that this could potentially, you know, be approved in the not too distant future, and the file would be imminent after the US. Got it. Thank you.
So, you know, accelerate the approval as much as possible. So, you know, we expect that, you know, this potentially, you know, could be approving and not to this in the future. And the file will be imminent after the US file. So, you know, we expect that.
accelerate the approval as much as possible. So we expect that this potentially could be approving and not to the future. And the file will be imminent after the US file. All right, thank you. Thank you.
Operator: Thank you for your question. We are now taking the next question. Please stand by.
Thank you for your question. We are now taking the next question. Please stand by. And the next question from our team is for Nandas, Fokukinine. Nandas, please go ahead. Here, Lenny is open. Great. Thanks for the question. So just two quick questions. Can you, team, if you could just walk us through how you see the CARXT opportunity evolving I think Billy used specifically stated that you feel this particular program is underappreciated. And just again, from that S-GNA, spend perspective.
Seamus Christopher Fernandez: And the next question from Timos, Fernandez, for Cook and me, partners. Please go ahead. Your Leni is open.
Unknown Executive: Thanks for the question. So just two quick questions. Can you, Tim, just walk us through how you see the CAR-XT opportunity evolving? You know, I think Billy, you specifically stated that you felt this particular program is underappreciated. And just, again, from that SG&A spend perspective, what do you think is necessary to really effectively promote CAR-X-T to kind of maximize the opportunity? And then just a second quick question.
What do you think is necessary to really effectively promote CARXT to kind of maximize the opportunity? And then just a second quick question. As we think about the tumor treating field's opportunity, obviously manufacturing to support the potential size of that market opportunity is going to be important. Can you just help us understand how you're going to approach that opportunity from a manufacturing perspective? Thanks.
Unknown Executive: As we think about the tumor treating field's opportunity, obviously, manufacturing to support the potential size of that market opportunity is going to be important. Can you just help us understand how you're going to approach that opportunity from a manufacturing perspective? Thanks.
Unknown Executive: Hey, Seamus, thanks for your question. I'll provide the manufacturing question to Josh. For your question on CarXT, the answer is, yeah, you're right.
A.J. May, thanks for your question. I'll provide the manufacturing question to Josh. For your question on CAR XT, the, yeah, you're right. I did say, in the people are underestimating the potential in China, and we believe that there are more than eight million people in China living with schizophrenia today, and we believe in this product. And we think that it's got
Unknown Executive: I did say, you know, people are underestimating the potential in China, and we believe that, you know, there are more than 8 million people in China living day, and we believe in this product, and we think that it's got the potential to treat multiple symptom domains as monotherapy or even, you know, junctive. So really, and out of the 8 million people, we know that 8, 4.3 million people are diagnosed with severe forms of schizophrenia in the national database. So these are, you know, truly, you know, truly, you know, significant figures.
in the national database. So these are truly, you know, significant figures. And so, and I think I hear, you know, my colleague Carol kind of clearing his throat because I think he may be adding some comments here and there, but feel pretty chime in, Harold, on the potential, you know, impact of CARXT, you know, on a kind of a tan the size of, you know,
Unknown Executive: And so, and I think I hear, you know, my colleague Harold kind of clearing his throat because I think he may be adding some comments here and there, but feel free to chime in, Harold, on the potential, you know, impact of CARCT on a kind of a tan, the size of, you know, you know, China. Yeah, thank you for the question too. It's clear that when we in license, KT, we were really keen on bringing something to China. We just differentiate.
in China. Thank you for the question, too. It's clear that when the in-licence CARIX-T, we were really keen on bringing something to China, we just differentiated.
Unknown Executive: We have found in Chi-XT in two studies now, in the E1 and in the E2, both of the emergent studies, that this drug is addressing the negative symptoms that are really difficult to treat with existing pharmaceuticals. So that was one major differentiating feature. The second one was the side effect profile. This is a totally different class of antipsychotics, and that alone is an important piece to remember because most of the other antipsychotics for schizophrenia come from the serotonin dopamine series and have a certain side effect profile, which is really problematic.
We have and see in Tirex T in two studies now in the E1 and in the E2 both of the emergency studies that this drug is addressing the negative symptoms that are really difficult to treat with existing pharmaceuticals. So that was...
one major differentiating feature. The second one was the scientific profile. This is a totally different class of drugs. And that alone is an important piece to remember because most of the other antithycotics for schizophrenia, they do come from the serotonin dopamine.
Harald Reinhart: That's one of the reasons why a lot of patients do not continue treatment. As far as the addressable patient population goes, there is a significant unmet need in patients with schizophrenia just because the negative symptoms are not adequately treated at this point in time. So we see this as a global issue, but we see it also in China, where there is a need to bring more psychiatric help to patients who are currently undeserved.
series and have a certain scientific profile, which is really problematic. That's one of the reasons why a lot of patients do not continue treatment. As far as the addressable patient population, there is a significant unmet need in the patients with schizophrenia just because the negative symptoms are not adequately treated at this point in time.
So we see this as a global issue, but we see it also in China where there is a need to bring more psychiatric help to patients who are currently undeserved. If the government drives to increase the numbers of psychiatrists and to help patients out with schizophrenia, much more so than in the past.
Harald Reinhart: There's a government drive to increase the number of psychiatrists and to help patients with schizophrenia, much more so than in the past. So from our perspective, we see a significant market potential in China, and we see it in a patient group that currently has very few options. Thank you.
So from our perspective, we see a significant market potential in China. And we see it in a patient group that currently has very few options. Thank you. Yeah, and James, to the second part of your question about what kind of infrastructure the commercial infrastructure is needed. We're not yet in the, we could provide a specific number later on as we're close to the approval launch. But.
Unknown Executive: Yeah, and Seamus, too, the second part of your question about what kind of infrastructure, the commercial infrastructure needed. You know, we're not yet in the, you know, we'll put, we could provide a specific number later on as we're close to approval and launch. But while the prevalence of disease in, you know, neuroscience is quite large, it's a pretty concentrated market. And so we believe that a sales team that's focused and smaller than, you know, even on oncology products will be sufficient.
While the prevalence of disease in the neuroscience is quite large, it's pretty concentrated market. And so we believe that a sales team that's focused and smaller than even an oncology product will be sufficient. And on top of that, it will be to leverage existing capabilities that we have that we've built for, for example, F-GAR in GNG and CIDP, as you know, that touches neurology. And so, you know, I think it will provide specific, you know, details later on, but it's going to be an efficient build-out.
Unknown Executive: And on top of that, we'll be able to leverage existing capabilities that we have that we built for, for example, FG and GNCIDP, as you know, that touch neurology. And so, you know, I think it will provide specific details later on, but it's going to be an efficient buildout. Thanks. I'll take the manufacturing question on TT Fields. Thanks, Seamus.
Joshua L. Smiley: I think first, this is hopefully a great problem to have. Of course, Novakure's been, you know, focused on the breadth and size of the opportunity for many, many years and has a series of strategies in place to work to bring down manufacturing costs for the device. And I think if we look at the China opportunity, of course, it's going to be driven by the data, but if you look at the studies that are underway today across various tumors as well as, you know, where the data could lead us, I think our view is there are probably somewhere in the range of 1.8 million patients in China who could benefit from the technology over time.
that are underway today across various tumors as well as, you know, where the data could lead us. I think our view is there's probably somewhere in the range of 1.8 million patients in China who could benefit from, you know, could benefit the technology over time. So the volumes that we're considering and thinking about here could be...
Joshua L. Smiley: So the volumes that we're considering and thinking about here could be quite significant. With those volumes, I think there are very good opportunities to bring down unit costs, and we're working closely with Noviure on those strategies. And again, they've got the same view as they look at the world, not just China.
Joshua L. Smiley: But I think we're excited about the commercial opportunity. We certainly believe that GIFT, the potential volumes here, the supply chain and manufacturing strategies that, you know, that Novatore's working on and that we're partnering with that one, we'll be able to have this, you know, very attractive economic proposition as well, both at gross margin as well as at the bottom line. So again, I think the big focus for us, of course, will be to get through the lunar data to see the readouts from the study on other tumors, but we're well, you know, we're well aligned with Nocapure and well prepared to supply the volumes that we think can benefit Chinese patients and to be able to do that at a reasonable gross market. Thank you for your question.
but I think we're excited about the commercial opportunity. We certainly believe that gets me.
The potential volumes here in the supply chain and manufacturing strategies that the Nova Tours are working on and that we're partnering with them on that we'll be able to have this be a very attractive economic proposition as well with both that Grossmargin as well as that being.
at the bottom line. So again, I think the big focus for us, of course, will be to get through the lunar data to see the readouts from the study and other tumors, but we're well lined with noepure and well prepared to supply the volumes that we think can benefit Chinese patients and to be able to do that at that point.
Operator: We are now taking the next question. Please, stand back.
Yang Wang: And the next question is from Yang Wang from Credit Swiss. Please go ahead. Uran is open. Thanks for taking my questions. I have two.
You don't need to go through that. Thanks for taking my questions. I have two. First one is about the Luna trial. We know that we're going to be a Luna data in the first half of the year. And I think people are probably including us.
Rafael G. Amado: The first one is about the lunar trial. We know that we are going to see lunar data in the first half of this year. And I think people are probably, including us, more interested in understanding some subgroup analysis for Luna, right? Given the Lunar trial in a row both in the first line, people only receive chemo, and the people. people who receive PD1 plus chemo. So my question is, Is it the case that the subgroup analysis for the patients who receive PD1 plus chemo in the first line is a kind of key to allow us to file?
more interesting and understanding some subgroup analysis for Luna, given Luna trial in Robo's first line, people only receive chemo and people receive PD1 plus chemo. So my question is, is that case that the subgroup analysis for...
the patient who receive PD1 plus chemo in the first law is a kind of key to allow us to file. And in the worst case, that's a similar worst case scenario. If the subgroup analysis in the PD1 plus chemo group is not that great considering the treatment landscape is different between US and China. Well, that I'll still consider.
Rafael G. Amado: And in the worst case, let's assume a worse case scenario, if the subgroup analysis in the PD1 plus chemo group is not that great, considering the treatment landscape is different between US and China, will Zaylab still consider filing for the indication? That's my first question. This is, Raphael, I think this is, this one's for you.
for the indication. That's my first question. Thanks. I think this one for you. Yeah, I'll take the question. Thanks for this insightful question. I think the most important thing is to understand that the study met its primary end point with all statistically and clearly meaningful results.
Rafael G. Amado: Yeah, I'll take the question. Thanks for this insightful question. I think the most important thing is to understand that the study met its primary endpoint with both statistically and clinically meaningful results on the primary endpoint. And, you know, in any study, that's really what matters. It is a randomized trial, and the population being studied is the post-platinum population. So, prior P1 is not an exclusion criteria.
on the primary endpoint and in any study that's really what matters. It is a randomized trial and the population being studied is the post-platinum population. So, prior PD1 is not a solution criteria. And the studies are on the mind. So, we see and start to put...
Rafael G. Amado: And the study is randomized, obviously, and stratified as well, and factors are supposed to mitigate patient imbalances. So the important point, I think, is that regardless of the makeup of the PG1 subgroup, there was a statistically significant and clinically meaningful difference in overall survival in the overall population and in the PD1 subgroup, with a trend in the dositactyl group.
and try and fight as well and factor are supposed to mitigate curtailioning balances. So the important point I think is that regardless of the makeup of the PD1 subgroup there was a statistically significant and clinically meaningful difference in overall survival in the overall population and in the PD1 subgroup with the trend in the dosicato group.
Rafael G. Amado: So the details of the patient's characteristics and prior treatment history will be shared in future data presentations, and the release is on by nookier. So rather than speculating on subgroups, I think it's best to just wait for the full analysis of the data set to interpret the results. But, you know, we should be cautious about subgroup analysis and really focus on the primary analysis, which had results that were pretty exciting as reported when Okay, I got it.
So the details of the patient characteristics and paratriming history will be shared with each of the data presentation and the release and so on by no keyer. So rather than speculating on subgroups, I think it's best to just wait for the full analysis of the data set to interpret the results. But we should be cautious about subgroup analysis and really focus on the primary analysis which had results that were pretty exciting as reported when I was here.
Rafael G. Amado: Yeah, my second question is about the epithic model, commercial preparation, as we understand, this is a kind of real disease in China as well. And so can the company please let us know whether it has started to try to identify some MG patients just to prepare for the launch of the drug? And if it's so, can you let us know how many MG patients you have identified so far. Yeah, hey, Yang, I'll take this
Okay, got it. My question is, have you got more commercial preparation as we understand these kind of real disease in China as well? And so, can a company let us know, has company started to try to identify some MG patients? And so, can a company it to identify anyone can identify one of California's
Just to prepare for the launch of the drug and in the episode, can you let us know how many MG patients you have identified so far? Yeah, hey, young, I'll pick this one. So first of all, the dressable patient pool is quite large for MG. We're talking about a prevalence, about 200,000.
Unknown Executive: So, first of all, the addressable patient pool is quite large for MG. We're talking about a prevalence of about 200,000. And we strongly believe that FGAR-TIGMOD will become a very important treatment option for these patients. It's early days, but we have started to build awareness ahead of the anticipated approval and launch. As you know, we've launched a program and part of China. Where, you know, patients can potentially get access. It was really more for strategic purposes, given travel restrictions up until recently, but it really allowed us to engage, you know, with not only physicians but patients and get some feedback and responses.
And we strongly believe that a partige mod will become a very important treatment option for these patients. It's early days, but we have started to build awareness ahead of the anticipated approval launch. As you know, we've launched a program in a part of China where patients can potentially get access. There was really more for a strategic purposes, giving travel restrictions up until recently, but it really allowed us to engage with not only the physician, but patients and get some feedback responses. And it's...
Unknown Executive: And it's quite encouraged by what we see, and no surprise, given what's been happening outside of China, I believe our Gen XX just reported, you know, a pretty strong first-year sales and engagement and, you know, whatever metrics that you follow on the commercial side.
quite encouraged by what we see and no surprise, right, given what's been happening outside of China, I believe. Our genics just reported, you know, a pretty strong first-year sales and engagement and whatever measures that you follow on the commercial side. So, I think that provides a nice read through for deep potential and opportunity in China. Okay, great. Thank you.
quite encouraged by what we see and no surprise, right, given what's been happening outside of China, I believe, are generally just reported, you know, pretty strong first year sales and engagement and whatever measures that you follow on the commercial side. So I think that provides a nice read through for a deep potential and opportunity in China. Okay, great. Thank you. Thank you for your question. Thank you.
Unknown Executive: So I think that's provided a nice read-through for the potential and opportunity in. Okay, great. Thank you. Thank you for your question. There are no further questions at the moment. I will hand it back for closing romance. Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the first quarter of 2023. Afterker, you may not disconnect the call.
There are no further questions at the moment. I will hand back for closing remarks. Thank you, operator. I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the first quarter of 2023. Operator, you may not disconnect the call. The conference will begin shortly. To raise and lower your hand during Q&A, you can dial Star 11.
Operator: The conference will begin shortly. To raise and lower your hand during TUNA, you can dial star 1-1.
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