Q4 2019 Earnings Call
unknown: Unsponsored ADR [inaudible] Unsponsored ADR Unsponsored ADR Unsponsored ADR Copyright 2019 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
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unknown: Hello ladies and gentlemen, thank you for standing by, and welcome to the Zai Labs full year 2019 financial results and corporate updates conference call. At this time, all participants are in a listen-only mode. Later, we will... conduct a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It's my pleasure to turn the floor over to Billy Cho, Chief Financial Officer of Zai Lab, who will make introductory comments.
Unknown Attendee: Thank you, operator. Good morning, and welcome to Zai Lab's full year 2019 financial results and corporate updates conference call. Earlier this morning, Dial-Aid issued a press release providing the details of the company's financial results for the 12 months ended December 31, 2019, as well as recent corporate updates. The press release is available in the Investor Relations section of the company's corporate website at ir.zailaboratory.com. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder and Chief Executive Officer. We will be joined by Tao Fu, President and Chief Operating Officer, who will provide more details on our pipeline, including upcoming milestones and commercial progress. Dr. Valeria Fantin, Chief Scientific Officer, and Jonathan Wang, Head of Development, will also be available to answer questions during the Q&A portion of the call. Because some of us are dialed in separately, Samantha will take the lead on the questions and defer to Chou, Valeria, Jonathan, and myself as needed.
unknown: As a reminder, during today's call, Zai Lab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including the business plans and objectives, and the timing and success of our clinical trials, regulatory applications, and commercial launches. Such forward-looking statements are not guaranteed to result, and therefore you should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our S&P findings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to Zai Lab's Founder and Chief Executive Officer, Dr. Samantha Du.
Ying Du: Thank you, Jimmy. Hello, everyone, and thank you all for joining us. First and foremost, I hope everyone is safe and sound as the global efforts to contain the coronavirus have impacted all of us. This devastating outbreak really shows how important global healthcare and coordination will be in the future. On a brighter note, I'm excited to provide an update on all the progress Zai Lab has made in 2019. Sunlight is at its inflection point, and I have great enthusiasm for what the future holds for us.
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Welcome to be side labs for 2019 financial results on corporate update conference call.
At least on all participants listen only mode.
We will.
unknown: Coinciding with the celebration of our 5-year anniversary, 2019 was a year of many important achievements for Zai Lab. Some of the key milestones achieved were the China NMPA regulatory approval for Zazula, the second line for ovarian cancer, and two additional submissions for regulatory approval in China for obtained and automated studies. Collaboration of Women, Safety Safers, and Seamstice.
Conduct a question answer session and instructions will follow.
unknown: Continued build-out of a commercial platform in China, launched ZULA and Optune in Hong Kong, and further enhancement of our global in-house R&D capability. Today, our portfolio consists of three commercial products and nine late-stage aspects being evaluated in more than 25 clinical trials across oncology and infectious disease. Looking ahead in 2020, we have another pivotal year coming up as we have or expect to file three submissions for approval in China.
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unknown: Deliver key clinical readouts, announce new strategic deals, and, as promised during our IPO, advance two discovery programs with global rights to R&D submission. We are proud of our global reputation as a biotech pioneer and a partner of choice in China, as we continue to deliver exceptional execution across global and local clinical development, regulatory affairs, business development, commercialization, and infrastructure expansion. Within the next three years, we believe Zai is well positioned to reach our vision of becoming a leading global biopharma company with a steady stream of approvals and commercial launches in greater China across multiple therapeutic areas. Internally Generated Global Physical Stage Pipeline Assay, and Transformative Partnerships. With regard to recent updates... First, the impact caused by the coronavirus outbreak. Global Health Authority has appropriately outlined the seriousness of the outbreak, both in China and globally.
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As a reminder, during today's call xylem, we'll be making certain forward looking statements within the meaning of the private Securities Litigation Reform Act like 95.
Including our business plans objectives, the timing and success of our clinical trials regulatory applications and commercial launches.
Such forward looking statements are not guarantees of future performance and therefore should not put undue relies upon them.
These statements are subject to numerous risks and uncertainties that could cause actual results could differ materially from what we expect.
For your tortoise the findings for discussion of risk factors that could cause actual results to differ truthful those discuss today.
At this time, but it's my pleasure to turn the call over 2000, <unk> Chief Executive Officer Dr. Celeste.
Thank you Peter.
Hello, everyone and thank you all well Jordan Huh.
unknown: While it may be too early to speak to the ultimate impact on our company, Zai Lab currently does not expect to be materially impacted by this unfortunate event, in part due to the comprehensive safety measures we have quickly implemented across our firm. None of our employees have been infected so far, and we have clear procedures in place to deal with any situation should it occur. Every company will be impacted differently by the virus. Well, we have seen some disruptions in our world.
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unknown: Certain aspects of operation during the first two months of 2020; we do not see the need to change our key clinical, regulatory, and commercial milestones at this time. Having said this, we continue to monitor the situation very closely. We're doing everything we can to make sure all constituents, our employees, the medical community, patients, regulatory agencies, and partners are safe and supportive. Moving on to other highlights.
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unknown: We recently announced in January that Zai Lab successfully raised total gross proceeds of approximately $300 million, which combined with our CAD position at the end of 2019, of a pro forma tax petition exceeding $550 million, and current market conditions. Such financial strength should enable us to execute all of our key strategic initiatives as we continue to expand our business. I'm also thrilled to announce that following the China MDA acceptance of ometacetylene this February and despite the turbulence caused by the coronavirus outbreak, our SMDA for Tizoula as a first-line maintenance treatment for larynx cancer patients was accepted in China by the NMPA this week. I believe ZULA, as a first-line normal therapy treatment after surgery and patent-based chemotherapy, has the potential to fundamentally change how women with ovarian cancer are treated in China.
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unknown: On the commercial front, I'm pleased to report that both Zezula and Alstom have outperformed our revenue targets in 2019. According to IQVIA, Kizula was not only the leading car inhibitor in Hong Kong with a market share of 71% last year but also ranks among the top five oncology drugs ever to launch in Hong Kong as measured by first four-year revenue. We also understand from our partner, Novacure, that our Poon Lodge in Hong Kong represented one of the most successful launches globally. Needless to say
We believe site well position to reach our vision of becoming a leading global Biopharma company with a study CE approval and commercial trends in greater China across multiple therapeutic area.
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unknown: We are excited to commercialize this law and obtain it in China soon. Well, it's too early to comment on the long trajectory of Suzhou in China. They believe there are significant commercial opportunities. More importantly, we are excited that we have already started to address the unmet medical needs of plenty of sensitive or varying kinds of patients in China. Building our own global discovery pipeline is one of the key pillars of Zai Lab's long-term growth strategy, and I am pleased to report that we are making good progress on this. We have prioritized three areas of research that include DNA damage response, immuno-oncology, and signal translation.
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unknown: We are advancing our pipeline of assets in those areas by building our internal expertise in translational medicine and the precision medicine approach, and by exploring the inter-portfolio combination. We will start to progress our first two global programs into the IMD stage this year. We need workforce talent to achieve our goals, and we intend to continue to build and add that to our global team across all functions. We have opened a Boston office this year and plan to open a larger facility in San Francisco for the Discovery Organization this summer. As of February 2020, Zai Lab employed 733 full-time employees across seven offices globally, with 293 and 340 employees engaged in R&D and commercial activities, respectively. This is a very exciting time at Zai Lab.
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unknown: Our strategic mission is on a global scale, and we believe we have the experience and resources required to successfully reach our goal. I've always. We want to thank you for your continued support and interest and look forward to keeping you updated with all of our upcoming milestones. With that said, I would now like to turn the call over to our President and COO, Tao Xu.
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Hello, as a first my name is Switzerland or burn cancer patients.
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I'd elite as low as first line monotherapy treatment also says he and platinum based chemotherapy.
Has the potential to fundamentally change how women with ovarian cancer treatments in China.
unknown: Thank you, Commander. As Samantha mentioned, 2019 was an extremely busy and exciting period for Zai Lab on a variety of fronts. We became a commercial stage company with the successful launches of Zajula in Austria, and we gained approval of Joola in Mainland China. We further expanded our portfolio with two new strategic partnerships, expanded our China commercial organization and our global R&D team through the recruitment of top-level talent, and significantly strengthened our balance sheet to further enable Zai Lab to bring many more important therapies to patients. While our press release for this morning provides detailed updates across most of our programs, I'd like to focus my comments today on a few selected programs and near-term catalysts. That said, we'll be happy to answer any questions during the Q&A session on any assets that are not covered in our prepared remarks.
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We also understand from all the partner Novocure that opt to last year in Hong Kong represented one of the most successful long fits globally.
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We're excited to commercialize this little an opinion tightness.
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unknown: I'll start with Neuropil or JULA, a heart inhibitor approved globally for the treatment of ovarian cancer and in development for several other solid tumor indications. We believe that it is the best-in-class PARP inhibitor with an attractive efficacy and safety profile without the need for blocker testing and superior pharmacological properties, including once-daily dosing, low drug-drug interactions, and the ability to cross the blood As you know, Sejula was approved by the China NMPA in December for second-line maintenance treatment of platinum-sensitive ovarian cancer patients, making it the first and only Category 1 TARP inhibitor approved in China. As Samantha noted earlier, this approval represents the fastest timeline for submission to approval in China for locally manufactured Category 1 oncology drugs in 2019.
We believe there significant commercial opportunity.
More importantly, we have decided that we have already started to address the unmet medical need.
Platinum sensitive ovarian cancer patients in time.
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Immuno oncology and technical translation.
We are advancing our pipeline I stress in those areas by beauty RV internal expertise.
Translational medicine, and precision medicine approaches and bikes floored into a pool photo combination.
unknown: Underscoring Zi Lab's execution track record and leadership in bringing important therapies to patients. In addition, our FMDA for ZULA as a first-line maintenance treatment for ovarian cancer patients was recently accepted by the NMDA. This submission was based on the results from the PRIMA study that demonstrate that women in both the HR-efficient or HRD-positive and HR-proficient or HRD-negative subgroups experience a clinically meaningful and statistically significant benefit.
With that supports all the first two global programs into the I'd be stage this year.
We need work Clos pilots.
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We intend to continue to be ads, that's sort of how the global team across all functions.
We have opened it boss snow pieces here and climb toward larger facilities. That's Francisco would have discovered okay. My vision this summer.
I've got separately couldn't fits into that a lot employees doesn't hunger circuits, we full time employees across seven offices globally.
unknown: In addition, Zai Lab recently completed enrollment in the Phase III prime study of Jula in Chinese patients with first-line ovarian cancer. We're excited for an opportunity to bring this potentially game-changing label expansion to China as soon as possible. Regarding the commercial launch of Zadula in China, we're very proud of our team bringing this drug to the market in mid-January, expeditiously following the approval. In response to the challenges caused by the coronavirus outbreak, we have taken immediate measures such as creating online physician and patient education and counseling platforms. Getting the Jewel on Reimbursement Lists at Provincial and Municipal Levels and Maximizing Commercial Insurance Opportunities
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We believe we have to field resources required to successfully reach obstacle.
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They'll continue to support and interest and look forward to keeping you updated with all of our with upcoming milestones.
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unknown: We anticipate providing initial commercial figures from mainland China when we announce our next financial results and corporate update. In Hong Kong, I'm pleased to report that our commercial launch continues to perform ahead of our initial financial forecast. While Hong Kong is a small market compared to mainland China, we believe our initial performance validates two key items. First, the compelling profile of ZULA in the Greater China Region, and second, the capabilities of our commercial team.
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We became a commercial stage company.
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We gained approval of the jewelry in mainland China.
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Two new strategic partnerships.
unknown: Therefore, we believe many drivers of success in Hong Kong can be applied to our Mainland China launches to further position Zajula for success in our primary market. In today's early press release, we announced the termination of the Phase 3 study of neuroporib as first-line maintenance therapy in patients with small cell lung cancer due to the rapidly changing landscape in treatment options. While this may be a setback for small cell lung cancer patients, we can refocus our resources and attention towards other indications with higher unmet clinical need and commercial opportunities for de jure. In regards to other indications, we recently dosed the first patient in a Phase 1b combination study of Neuroporib with MGD-013, a bispecific PD-1 Log-3 dark molecule, in advanced and metastatic gastric cancer, and we plan to Looking ahead, we're committed to making a meaningful impact on the way cancer is treated in China and globally. We believe Joola is a potential best-in-class heart inhibitor, and our plan is to continue to develop Joola in order to bring this innovative treatment to as many patients who may benefit as possible, including in indications beyond ovarian cancer.
Funded or China commercial organization Global R&D.
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And significantly strengthened our knowledge to further enable bylaws to be maybe more important therapies to patients.
I believe for this morning provides detail Apaziquone most also.
I'd like to focus my comments today on a few selected.
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That are not covered.
I'll start with Robin the Jewel PARP inhibitor.
For the treatment.
In development for several other solid tumor indications.
We thought it is the best in class PARP inhibitor with attractive efficacy and safety profile with all the need for block the testing and superior pharmacological properties, including once daily dosing load was talking a Russian and the ability to cross the blood brain barrier.
Oh, you know the jewelry was approved by the China.
Number four second line maintenance treatment.
Sensitive ovarian cancer patients.
Let me first and only one PARP inhibitor.
Oh the month of noted earlier.
Represents the fastest timeline from submission to approval in China for locally manufactured how to get one oncology drugs in 2019, underscoring bylaw execution track record leadership, including important therapies to patients.
unknown: Now turning to tumor treating fields. If we can obtain a clinical trial waiver, we expect to receive the marketing authorization approval for Optium, the tumor treating field delivery system for the treatment of glioblastoma, in the first half of 2020. We view our initial commercial success in Hong Kong as a very encouraging time for opt-in and the unmet needs it can address in mainland China.
In addition, our up and be able to jewel.
First line maintenance treatment for ovarian cancer patients with recently accepted.
This submission based on a result.
unknown: As you may know, NovoCure received approval from the U.S. FDA for a new indication last year for malignant pleural mesothelioma. We plan to file an MAA, or marketing authorization application, for NovoCure in mesothelioma with the China NMPA this year. While mesothelioma is not one of the major cancer types in China, the approval will be very strategic for us given that the next label extension opportunity is in non-small cell lung cancer. Beyond glioblastoma and mesothelioma, there are a number of exciting anticipated milestones ahead of this program.
Studies demonstrate the woman in both HR deficient for each party positive and HR profession HRT negative.
Experience clinically meaningful and statistically significant.
In addition, biologic recently completed enrollment of the phase three points study.
Try these patients with gross line ovarian cancer.
Were excited for an opportunity to clean just potentially game changing label expansion to China Austin Oh.
Regarding the commercial launch of the jewelry in China.
Our team we didn't have dropped to the market in mid January expeditiously Bullwinkle.
unknown: In particular, Novacure expects to announce interim results from its Luna Phase III trial in patients with non-small cell lung cancer in the second half of 2020, which has significant market potential in China. We also have an ongoing Phase II pilot clinical trial in first-line gastric adenocarcinoma, which is going well. Just as a reminder, the annual incidence rate in China for lung cancer and gastric cancer is over 733,000 and 679,000 diagnosed patients, respectively, according to the 2015 National Cancer Statistics. Now on to recruitment.
In response to the challenges cool by the Corona virus outbreak, we are taking immediate measures such as creating all lines physician and patient education hopefully.
Getting the jewel reimbursement list provincial and municipal level and optimizing commercial insurance opportunity.
We anticipate providing initial commercial figures from mainland China. When we know now our next financial result, corporate update.
In Hong Kong I'm pleased to report that all commercial launch continues to perform ahead artificial financial forecasts.
unknown: Our investigational kit and PTGF-alpha kinase switch control inhibitor is licensed from the FDA. In February 2020, our partner, DSEFRA, announced that U.S. FDA acceptance under priority review of its NDA for recritinib in patients with advanced gastrointestinal stromal tumors, or GIST. The submission was based on compelling data from the Pivotal Phase III Invictus clinical study of reprisonment in patients with advanced GIFs, where the study met its primary endpoint of a significantly improved median progression-free survival of 6.3 months compared to one month in the placebo arm, and the risk of disease progression or death was reduced by 85% or a hazard ratio of 0.15 compared to placebo.
Well, Hong Kong as a small market compared to mainland China. We believe our initial performance validates two key items.
First the compelling profiles in the greater China region, and second the capabilities of our commercial team.
Therefore, we believe many drivers for success in Hong Kong.
Slide into our mainland China launches.
Missions as you look for success in our primary Mark.
In today's earnings press release, we announced the termination of the phase three study over the Whopper in first line maintenance therapy in patients with small cell lung cancer due to the rapidly changing landscape in treatment.
Well this maybe a thoughtful small cell lung cancer patients, we can refocused our resources attention towards other indications with higher unmet clinical need and commercial opportunity.
unknown: Looking ahead for Zai Lab in China, we plan to submit an NDA to the Chinese NMTA for fourth-line advanced JITs this year and initiate bridging trials for second-line JITs in the second half of 2020, and next with matritoxamab. Zai Lab announced last month that the first patient has been dosed in the Registrational Bridging Study of matritoxamab in combination with chemotherapy for the treatment of patients with non-static HER2-positive breast cancer. This follows the BLA submission to the U.S. FDA for marzituximab by our partner Nocrogenics for the treatment of patients with non-static HER2-positive breast cancer in combination with chemotherapy. Looking ahead, Narcogenics expects to present final data from the Phase III SOFIA clinical trial relating to positive metastatic breast cancer by the end of 2020.
In regards to all indications, we recently dosed the first patient phase one be combination study on the Robert.
Oh 13, a bi specific PD, one laclede dart molecule in advanced metastatic gastric cancer and we plan to continue to work closely with our partner Gfk pursue other label expansion opportunity.
Looking ahead, we're committed to making a meaningful impact on away cancer is treated in China and global.
We believe the July the potential best in class PARP inhibitor and our plan is to continue to develop the jewelry in order to bring this innovative treatment of many patients only benefit as possible, including indications beyond ovarian cancer.
Now turning to tumor feeding field.
We can obtain a clinical trial waiver, we expect to receive the marketing authorization approval.
unknown: In addition, Zai Lab expects to enroll Chinese patients in the Phase II-III mahogany study to evaluate the combination of margituximab, a checkpoint inhibitor, and chemotherapy as frontline treatment for advanced gastric cancer. And finally, an update on omatocycline, our once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired pneumonia and acute bacterial skin and skin structure infections for our anti In February 2020, Zai Lab announced that the NMPA had accepted its NDA with Category 1 New Drug Destination. We also announce today that we entered into an exclusive promotion partnership with Hanhui, a leading player in the anti-infective area in China, with established commercial infrastructure and extensive promotion and distribution network to market OmniCycle. The rationale behind this partnership was to expand Omicron's cycling footprint to a much broader Chinese market and maximize its commercial potential as a broad-spectrum novel antibiotic in the community sector.
The tumor treating fuel delivery system for the treatment of real glaucoma first half of 2020.
We view our initial commercial success in Hong Kong.
Charging and mindful option and the unmet need and address in mainland China.
Oh, you May know no cure received approval from the U.S. up for new indication up here for Mulligan overall needle TV.
We plan to file M&A or marketing authorization application Unico PB almost to the China Annunciate this year.
Well people, who your line is not one of the major cancer types in China approval will be very strategic for us given that the next label expansion opportunity in non small cell lung cancer.
The on can you walk doma and people can be OMA or a number of exciting anticipated milestones ahead of this program.
Particular, no what you expect to announce results from if you do know phase three trial in patients with non small cell lung cancer. The second half of 2020.
We have a significant market potential in China.
We also have an ongoing phase two pilot clinical trial in first line gastric adenocarcinoma, which is rolling well.
unknown: As for the rest of our late-stage pipeline assets, including our oncology portfolio and our dolobactin, which is different to omatocycline in that it requires a highly specialized sales team focused on large hospitals and ICUs, we intend to directly market these products ourselves. With that, I will hand the call over to Billy Chou, our Chief Financial Officer, who will provide an overview of our financial highlights.
Just a reminder.
Since rate in China for lung cancer gastric cancer are over 733000, and 679 solvent diagnosed patients effectively according to the 2015 national cancer.
No for refunded.
Investigational kit and PPG off also I need to switch control inhibitor license with itself.
Billy Chou: Thanks, pal. I will now review our financial results for the 12 months ended December 31st, 2019. Revenue for the period was $13.0 million compared to $129.5 thousand in 2018. Our revenues for the period were comprised of $6.6 million of sejoula sales in Hong Kong and Macau and $6.4 million of opt-in sales in Hong Kong. R&D expenses were $142.2 million for 2019 compared to $120.3 million for 2018. The increase in R&D expenses was primarily attributable to ongoing and newly-initiated late-stage clinical trials, payroll and payroll-related expenses from increased R&D headcount, and expansion of research efforts to support internal development programs. Selling general and administrative expenses were $70.2 million for 2019 compared to $21.6 million for 2018. The increase was primarily due to payroll-to-payroll related expenses from increased commercial headcounts and related costs as Zai Lab expanded its commercial operations in China.
Billy Chou: For the full year of 2019, Zai Lab reported a net loss of $195.1 million, or a net loss per share attributable to common shareholders of $3.03, compared to a net loss of $139.1 million, or a net loss per share attributable to common stockholders of $2.64% for the full year of 2018. As of December 31, 2019, cash and cash equivalents, and short-term investments totaled $276.4 million In addition, in January of this year, Zai Lab announced the closing of an underwritten public offering with total proceeds, net of underwriting fees and other expenses, of approximately $281.3 million. We would like now to turn the call back over to the operator so we can go ahead and take your questions. Operator.
In February 2020, our partner to Sephora announced at U.S. FDA acceptance under priority review of it and April represented in patients with advanced gastrointestinal stromal tumors or just the.
The submission was based on the compelling data for the pivotal phase three clinical.
Clinical study.
In patients with advanced chip, where to study met its primary endpoint of a significantly improved median progression free survival of 6.3 months.
There are two one month into placebo arm and the risk of disease progression on debt was reduced by 85% for how the racial I'll 0.15 compared to placebo.
Looking ahead with my lobby in China, we plan to submit an end to the China in NPK before fly advanced chip this year and initiate bridging trial for second line just in the second half of 2020.
And next with margins will come out I Love announced last month by the first patient has been dose in a registrational bridging study Moshe talked about in combination with chemotherapy, whether she's going to patients with metastatic hertwo positive breast cancer.
This falls the submission to the U.S. FDA for merger talks about file a parker not projects.
For the patients with metastatic hertwo positive breast cancer in combination with chemotherapy.
Looking ahead Lockwood Jack's expects to present final data for the phase three Sofia clinical trial in Hertwo positive metastatic breast cancer by end of 2020.
In addition, I love expects to enroll Chinese patients into phase two mahogany study.
Probably the combination of mater took not.
Checkpoint inhibitor and chemotherapy frontline treatment for advanced gastric and she'll Saltiel junction cancer.
And how 2020.
And finally, an update on all of the cycling oral once daily oral and intravenous antibiotic treatment of adult with community acquired bacterial pneumonia and acute bacterial skin and skin fluctuating sessions per hour unhedged infected pipeline.
unknown: Thank you, sir. We will now begin the question and answer session. We would now like to open the lines for questions. If you have a question, please press star 1 on your telephone keypad and wait for your name to be announced. If you wish to cancel your request, please press the pound or the hash key.
On February 2025 up and now nothing.
Has accepted NDA with category, one you would drop destination.
Also announced today that we entered into an exclusive promotion partnership with Huntway, a leading player in the on has effectively in China with established commercial do for foster an extensive promotion and distribution network to market almost likely.
Yigal Dov Nochomovitz: We have the first question from the line of Yigal... Nochomovitz, please ask your question. Hi, great. Thank you very much. Hi, Billy, Samantha, and Tao.
The rationale behind this partnership with expend almost a cycling footprint to a much quarter, China market and maximize its commercial potential other broad spectrum novel antibiotic in the community Center.
unknown: It is very good to hear that there were no coronavirus cases among your employees. I wanted to explore a bit more, however, the impact the coronavirus is having on the business. I know, Samantha, you mentioned that you don't expect a material impact on operations, but I would like to get a better understanding of what headwinds you might be seeing in the early days of the Naraparib Zijula launch in terms of reduced mutation starts given potential travel restrictions or closed position offices in the early innings. I do appreciate, obviously, that you did launch the product before the crisis became worldwide back in January, but nonetheless, it would be important for Thank you.
Oh for the rest of our late stage pipeline assets, including our oncology portfolio and our goal backend, which is different to all of the cycling in dotted it requires a highly specialized the sales team focused on large hospital a nice you use we intend to directly market these products ourselves.
With that I will hand, the call over to Billy Joel Our Chief Financial Officer will provide an overview of our financial highlights.
Thanks, how are.
Well I'll review, our financial results as well, but then that December 31st 2019.
Revenue for the period were $13.0 billion compare 229 point $5000 in that 2018.
Our revenues for the period were comprised of $6.6 million of the jewelry sales in Hong Kong Macau.
unknown: Thank you, Yigal, and that's a very fair question. And, as you mentioned, we're very fortunate we launched the product in mid-January before the outburst of the coronavirus. That was mainly during the second half of February and also the first week of March. The travel restriction was in China though.
Good point $4 billion, that's often sales in Hong Kong.
R&D expenses were $142.2 million for stuck in my team compare $240.3 million for stuff 18.
The increase in R&D expenses was primarily attributable to ongoing at newly initiated late stage clinical trials payroll and payroll related expenses from increased R&D headcount and expansion of research efforts to support in terms of both programs.
Selling general and administrative expenses were $70.2 billion for 2019 compared to $21.6 million for 2018. The increase was primarily due to payroll payroll related expenses from increased commercial headcounts and related costs.
unknown: So if you look at our sales activities in the first half of, second half of January till the mid of February, I didn't see any impact on our commercial launch, mainly because our team has been very effective in not only three weeks after approval but also in one day delivering all the supplies to 29 provinces and all the major hospitals. Unsponsored ADR, So we have got most of the CIs, especially the KOLs, through major upgrades. And so, during mid-February and March, in response to the challenges caused by the coronavirus, we have taken immediate measures, such as creating online physician and patient education and consulting platforms to deliver the products to patients. Unsponsored ADR
Hi that expanded its commercial operation in China.
For the full year, if it doesn't like team. So I love reported a net loss of $195.1 million or net loss per share attributable to common shareholders of $3 a three cents.
Compared to net loss of $139.1 billion, where net loss per share attributable to common stockholders of $2. A 64 cents for the full year of 2018.
As of December 31st because my team cash cash equivalents.
Shorts investments totaled $276.4 billion. In addition in January of this year dial up announced the closing of an underwritten public offering with total proceeds net of underwriting fees and other expenses of approximately $281.3 billion.
We would like now if it's hard to call back over to the operator, we can go ahead take your questions.
Operator.
Thank you Sir.
We will now begin the question and answer session.
We would now like to open the lines for questions. If you have a question. Please press star one on your telephone keypad and wait for your name to be announced if you wish to cancer to your request based press the pound well the hash key.
We have the first question from a lie enough that you Gal.
unknown: At the provincial and municipal level, within the first month, we had three municipal cities give us local reimbursement. Of course, we also work with medical insurance and commercial insurance companies. By now, we have already several patients treated with that commercial insurance provided.
No children moving so please ask your question.
Hi, great. Thank you very much high Billy and cement then tell very good to hear that there were no corona buying it first cases, among your employees and I wanted to explore a bit more however, the impact to the current a virus is having on the business I know cement that you mentioned that you don't expect immature.
unknown: Okay, great. Thank you.
unknown: Unsponsored ADR
Aerial impact.
On operations, but I would like to get a better understanding.
What headwinds you might be seeing early in the early days of be Niraparib is that you will launch in terms of reduced new patient starts.
Given potential travel restrictions or close physician offices in the early innings I do appreciate obviously that you did launch the product before the crisis became a worldwide back in January but nonetheless be important for us to understand what you're seeing in the field or was that without regard. Thank you.
unknown: Okay, so can you just confirm now that as of today, or I'm not sure what day, but you can tell me when did the sales force return to the field on a full scale?
Oh, Thank you recall and a that's a very fair question.
And Ah I feel mission.
unknown: Unsponsored ADR So I cannot say 100% by the end of the month. With that question, I have to answer based on the evolution of the coronavirus situation in China. But luckily, the coronavirus situation in China has been under control for a while, and we'd like to continue to see that before we can report the full self-procedure back to the field.
We're very fortunate with long product you meet generally.
Before the Oscars updates to come over.
And that's kinda mainly that to the.
Second half of February.
And also the first week of Ah Ah Mark So type of restriction, we spent some time ago.
So that if you look at all or those activities in what's possible for them how to generate.
The me, though I do it and I didn't see any impact on the.
Commercial launch mainly because I would team has seen a very effective.
Not only a long you three with softer football, but also you one day Delever Oh the supply to.
To be nice probably crew and Oh, the major hospitals.
But either do the out with probably fiction and outburst, even probably not we Ah we have seen some we have two from human Pat.
unknown: Okay, and then just quickly, in terms of anything you're seeing with respect to enrollment rates for the ongoing clinical trials, as well as the supply chain integrity for Zajula and Optune, with respect to, given the coronavirus pandemic, can you comment on any impacts there, or not?
But oh.
Oh, so a very oh for newer and bad there. So we lawfully how three a long you been parts of it.
So we had thought well most of the.
Yeah, I, especially the payroll out.
unknown: First, I think the supply has not been interrupted at all because, as I mentioned, we shipped the supplies on the first day after we officially launched the product in mid-January, and the first day delivery to all the hospitals, the pharmacies, and also from manufacturing sites. We have enough supply, and also the people are already back to work if we need additional supplies. And in terms of clinical recruitment, I have to say on this part, we are quite fortunate because we have several major recruitments and trials. And one already completed, not even patient recruitment, but we have already closed the study. We are in the process of data mining.
So that meets all three.
And so.
The meat Fabry and Mark.
Yeah, right through the sounds a bit calc better from a virus.
Have they can be needed immediate matters, but that gradient online division and patient I'd, the pace and consulting I suppose.
A deliberate the you lever the other two pacing.
At home or nearby promising.
And Oh, so pretty online well they'll create a working on greenberg betting on reimbursement.
The provision so we're comfortable within the first month, we were about three minutes before CP give us a local reimbursement of course, they also working with the medical Stuart.
Commercial maybe a commercially parent company I by now we have already several patients could be would that mostly still is the I've provided.
unknown: The other one, we already completed patient recruitment in November. And during mid-February to early March, we did see only 50% of patients who were coming back to the hospital for follow-on. But now we see more, as of this week and last week, we see more patients coming back for follow-on. And so, at this house, we are taking...
Okay, great. Thank you Oh, no political rolling or Oh, sorry, sorry, I call just one more lossless.
Those who want to record for the last two weeks.
We've seen a human not the the business because China relax on the type of restriction.
But we've seen the sales team has come back.
And we see more patients, but newpage insight on to that well treatment.
unknown: Either they are at the beginning of, we haven't announced it, but if you look at the clinical.com section of China's CFDA website, we have 10 recent approvals of TTAs, and they are in the process of getting RRD approvals and also the Human Genomic Office approvals. So the trial has not taken off yet, and some other trials. We are going on small bridging studies. They usually don't need many sites, and those we don't see impact.
Okay. So can you can you can you just confirm now but as of today or I'm not sure what day, but you can tell me when did the Salesforce return to the field on a full full scale basis.
I, Oh I'm sorry.
It is oh yeah.
Carl.
The other cell suppose had majority with Ah Ah back on the steel.
But they are still not full field bill visit directly to the visits to.
unknown: Okay, and then just the final question is, obviously, you've mentioned that you got the SNBA accepted by the NMPA for Zijula in first line. Is it the case that you will not need to wait for the prime phase three results to get first line approval as occurred with second line with the NOR trial? I just wanna confirm that the regulatory setup is the same.
To that to hospitals certain hospitals I love full died visit some hospitals to have limited time to I look to the visits.
So I cannot say you know.
ER hubs are person by end of the month of wells Weve. That's question that I answer they saw the evolution of they called our situation time.
Luckily the.
From a buyer situation in China has.
unknown: You've been...
I've been in control for awhile and the we'd like to continue to see back before we can report the full I still of course him back for the sale.
unknown: Unsponsored ADR
unknown: and was mainly based in the U.S. and also based on the PK PD study. However, we do have a second-line study. We're going to see the results, hopefully in the first half of this year, and we'll report back then. So, for the first line, we did not announce that we closed the study. And so, as you expect, the package we accepted, the majority based on the package from... and the same package, the TSK submitted from the primer study. But of course, there are other things we included, but the primer is the majority of the submission.
Okay, and then just quickly in terms of anything you're seeing with respect to enrollment rates for the ongoing clinical trials as well as the supply chain integrity firms that you a an opportune with respect given the current a virus.
Ah pandemic can you comment on any impacts there or no.
Oh source. So I think the supply has not being Ah you dropped at all because a we as I mentioned, we sure supplies.
And that first grade and but after we officially launch the product in in a meat generally and the first they get there, but the two gold the a hot those are promising.
unknown: Okay, understood. Thank you so much for your help and best of luck in managing and navigating through the remainder of the coronavirus crisis in China.
And so the arts way also tremendous that's true side, we have not supply and also the people already back work even need additional supply.
unknown: Thank you, Yigal. I think the regulatory team, in this regard, I have to really applaud their efforts because it's a major disruption to many businesses, and especially the regulatory team, which is inundated with many coronavirus requests. Unsponsored ADR
And the in terms of Clinicals recruitment I have to say.
We are quite well to me because we have we have scrubber winemaker recruitment the trials and a one already completed not even patient recruitment, but also to close the we've already close the study.
unknown: Thank you.
In the process data mining the other one we are already completed patient recruitment in November and bad.
Anupam Rama: We have the next question from the line of Anupam Rama from J.P. Morgan. Please ask your question. Hey guys, thanks for taking the question. Congratulations on all the progress and I'm also glad to hear that everyone's doing well at the company. I know that you have an infectious disease vertical at the company. Any thoughts on internal options or potential business development options that may present strategies for COVID-19? Thanks so much.
Jim the a meat factly too early March we eat piece.
What do you see almost 50% patients will work come you back for the hospital.
Belong.
Now we'd be more I, so they wait and last week with more patients coming but before long and.
So oh, we are making.
Either at the beginning of probably just like we haven't done now, but I do look at the clinical Dot Com mean, I'd love to see a theme that's side, we have had at least an approval. So <unk> and they are you the process of getting an hour be approvals and also the a human to Dominic office approach.
unknown: First of all, we do not have an in-house... Discovery Capability for Viral and also Bacterial and Anti-Infective, Unsponsored ADR However, we do look for opportunities for other anti-infectives, which we have been looking into. I will turn more details to Jonathan Wang, our Head of Business Development, to elaborate on this point.
We'll go with the power has not taken out yet.
From other trials, where I'll buoyant.
Mall, we'd been study they used to they don't need the maybe size and those we don't see impact.
Okay and then just the final question is obviously, a you've mentioned that you've got the SNB accepted.
By the N.P.A. present, you for for for first line is it isn't the case that you will not need to wait for the prime phase three results to get the first line approval as as it as it has occurred with a second line with an oral trial I just wanted to confirm that the regulatory set up is the same.
Jonathan J. Wang: Yeah, hi Anupam. Thanks for the question. I think we're evaluating a lot of opportunities and anti-infectives, as Samantha said. We look at both antibacterial as well as antiviral opportunities that have large medical needs, you know, especially in the Asia Pacific and China. You know, although we can't probably comment specifically on COVID-19, but within antivirals, we're looking at a lot of opportunities as well. So maybe, hopefully, that answers your question.
You mean because in China.
Yes in mainland China, Yes, yes, yeah in mainland China as you know we got the second line May Miss approval, Oh, so not based on the time out there.
unknown: Thanks for taking our question.
I wasn't majority it based on the U.S. and also based on the break the PK PD study.
Jonathan J. Wang: We have the next question from the line of Jonathan Chang from SVB Linrink. Please ask your question.
I would do Hadley for a second line then study going to Ah, we're going to see the result, hopefully this first topic here and live with poor bad debt.
So first line the Oh wait did not on a pretty closely Ya study and so as you expect the package we accepted majority base on the a package from.
unknown: Hi, congrats on the progress and thanks for taking my questions. First question, can you provide any color on the successful Zazula launch in Hong Kong and reasons for confidence that the success could translate into the Chinese launch?
And the state has so TSK submit it from the Primal study, but of course there are other right. We've included but is permanent prime or is the majority of the submission.
unknown: Jonathan, thank you for taking the time to participate in this call, and I will defer that to Jonathan.
Okay understood. Thank you so much for your help and the best of luck garden in managing and navigating through the remainder of the Corona virus crisis in China.
unknown: Yeah, thank you, Jonathan. As Samantha mentioned in our presentation earlier, the jeweler was launched at the end of 2018. And in its first full year of sale, it achieved pretty remarkable revenue and, you know, ranked basically among the top
Thank you can call I think God, the regulatory team I'm basically card I have to would applaud their iceberg.
Chris a it's a major in the disruption to many that the business and especially the regulatory Piedmont in new they'd if its many problem virus so with that.
unknown: Unsponsored ADR Unsponsored ADR Unsponsored ADR
Put in a both on the keep side not the treatment site.
Thank you.
We have the next question from a line of onto from Ramos from JP Morgan.
Just ask your question.
Hey, guys. Thanks for taking the question congratulations on all the progress and also glad to hear that everyone's doing well at the company I know that you haven't infectious disease vertical at the company any thoughts on internal options or potential business development options that may.
Present strategies are poor covert 19, thanks, so much.
As far so Oh, we do not have like eating hall style.
Discovery capability.
So.
Oh viral and also bacterial and a up in fact I paid status.
And Doug.
unknown: Q2. Can you highlight the strategic similarities and differences between Zhezhula and the potential Optum launch in China?
However, we do look for opportunities. So odds are include other anti infective.
Which we Oh a lot we have not looking into those I will turn more details to Jonathan Wong our head of business development to be left with Compass point.
unknown: Unsponsored ADR Yeah.
Yeah, Hi, and thanks to the question I think we're evaluating a lot of opportunities and think that give us. Some into said we look at both anti bacterial as well as anti viral opportunity that have large unmet medical needs, especially.
unknown: I think, you know, for our pipeline, if you look at it, we, whether life-threatening or discovery, are first in class, best in class profiles. In the case of Optune, it's, in fact, the only one in class.
unknown: So first and foremost, we believe we have a very strong product, which gives our team a lot of confidence, and that has been demonstrated in Hong Kong so far. That launch, as our partner Novacure has told us and has told many people, is probably their best launch out of all the geographies in terms of the ramp-up and the pickup in that location. Unsponsored ADR Unsponsored ADR, Got it.
Asia Pacific in China.
Although we come public comment specifically on cousin 19, but within anti viral we looking out a lot of opportunities as well.
Some three times as your question.
Thanks for taking my question.
We have the next question from the <unk> line of Jonathan Chang from S. VB Leerink. Please ask your question.
Hi, Congrats on the progress and thanks for taking my questions.
First question can you provide any color on the successful launch in Hong Kong and reasons for confidence that the success could translate into the China launch.
Hi, Jonathan said to Oh, taking the time and true up to fit this call, but how do you have heard that two dozen Jonathan.
Yeah. Thank you Jonathan United Cement the mentioned.
Oh I'm presentation earlier, the jeweler was launched at the end of 2018 and its first full year of sale.
unknown: We have the next question from the line of Marie Rae Crawford from Jefferies. Please ask your question. Hi everyone, congrats on the progress and thanks for taking my questions. The first question is just on the launches; just wondering if you can provide any more specifics on the patient starts in Hong Kong for Zajula and Optune and then for Zajula in China.
I'm actually pretty remarkable revenues and get a ranked basically amongst the top five oncology drugs I would ever launched in Hong Kong.
Behind the likes of Keytruda Opdivo to centric inside research and you know, we also or the true how competitive job, even though we launched about 18 months after being positive. So we now have over 70% knock a share in Hong Kong.
Marie Rae Crawford: Jonathan, do you want to continue your discussion?
For the full year 29 team based on like studio Imus side or.
unknown: Yes, sorry, I just want to clarify. Do you mean the patient numbers in Hong Kong for both products? Yes, if you're willing to provide that info.
You know some commercial launch of uncle was very strong and we hope confident that we can replicate the success.
In China over time and anybody by the success is primarily due to you know having this best in class a as well as having a very experienced team has clearly demonstrated the ability to execute and other wrap the rent upsales and even in China. Despite the current about it.
unknown: Oh, okay. Thank you, Maureen.
unknown: Unsponsored ADR
unknown: Yeah, we currently do not have the split in Hong Kong for patients from mainland China and also from Hong Kong. So we are not in a position to split that number yet.
Situation I see the team was able to mobilize very quickly.
unknown: And for the bridging trial for repratinib and second line gist, just wondering if you can comment on how many patients you're going to need for that study and will you need the study results from that in order to submit the NDA?
You know for the launch in China in fact, the order product that was of crudes at December in China last year, we were the only product that was launched in January 2020.
Got it. Thank you second question can you highlight the strategic similarities and differences between business you learn potential optune launch in China.
unknown: So correct me, Maureen, you are mentioning the second line, right? Not the fourth line.
unknown: That's right.
unknown: Okay, so on that second line, we have two choices. We can either work with our partners to contribute to the global patient recruitment, or we can do a small parallel study while they are doing the global trial. So it depends on our partners' progress. We may go either way.
Some say you can it's all in for that section.
Yes.
Yeah, I think you know for a pipeline if you look at it you know we whether licensing on discovery is first in class best in class profiles.
And the pace of up to its in fact, the only in costs. So first and foremost we believe we have a very strong caught off.
unknown: Got it. And last quick question is just on OMADA cycling; just wondering if you can provide more specifics on the agreement with Henway and what the terms are there.
Which gives out seem a lot of confidence and that has been demonstrated in Hong Kong sort of Ah you know dot launch.
unknown: Thank you. I'll turn the questions to Paul.
Oh pardon another cure has called US and has told you know many people is probably the first launch out of all the joke fees in terms of the ramp up into pickup.
unknown: Yeah, sure, sure, Maury. Thanks for your questions.
In that location.
unknown: As we mentioned, this is really a CSO agreement. So we really retain all the development rights, regulatory rights, and will continue to be the MNH holder. But we grant exclusive promotional rights to Han Hui, which is one of the leading anti-infectious players in China. They have over 800 sales reps in the anti-infectious business. And if you think about this product, it really is a broad-spectrum antibiotic that has a lot of use in the community setting. So you really need a pretty large primary care sales force to promote this kind of product. So we think this is the best go-to-market strategy versus building a primary care sales force ourselves. As for terms, I think we should book all revenue. We will receive upfront payments and milestone payments, and there will be a profit split mechanism for their promotional efforts.
And having you know done very well.
Last year, I think that gives out seem very strong confidence in China and as you may note in China or you know she is also included in the national treatment guideline, which the official guidelines at the physicians should Colo and I'm going to tell the patients that.
There is this treatment option available for them.
So you know I think with all these positive you know on the back of Hong Kong as well as physician endorsement. We're very confident you know about the launch of up true in China once its approved.
Got it thank you.
We have the next question from the line of ER Marie Ray Crawford from Jefferies. Please ask your question.
Hi, everyone. Congrats on the progress and thanks for taking my questions.
unknown: Got it. Okay. Thank you very much for taking my questions.
First question is just on a though the launches just wondering if you can provide any more specifics on the patient starts in Hong Kong offers a July and Optune and then for is the July in China.
unknown: Yeah, also, Maureen, I just want to add a line. This is our first primary care, and it's also anti-infective. That's why we'd like to work with a partner on this.
Jonathan he wasn't he continually out discussion.
Yes, sorry, I, just want to car, but you need to the patient numbers in Hong Kong full for both products.
Yang Huang: Okay, understood. Thank you. We have the next question from the line of Yang Huang from Bank of America. Please ask your question.
Yes, that's if you're going to provide though.
Yes, Okay. So Maria.
unknown: Thank you. Thank you for taking my question and congratulations on all the progress. It is good to know that everyone is doing great on the ground. My first question is, I think earlier in the call you mentioned opportunity. It is really important to get the second education in myeloma, which has some indications for getting lung cancer.
Yeah, you wait carbonates and not have to predict.
Hong Kong, followed the patients from mainland China and also walk from Hong Kong. So we're not in a position to beat that number yet.
Understood and toward the bridging trial to refresh and Theyve been second line just I just wondering if you can come in and how many patients if you're going to need for that study and will you need. That's the study results from that in order to submit the NDA.
unknown: Do you mind if I further elaborate on that point?
So correct me I'm, sorry, you up mid second line right now that's not the Florida fulfil for long.
unknown: Sure. Thank you, Yang, for joining the call and thank you for your time. I'll turn the question to Tao.
That's right.
Okay, well second line, we are we have two choices.
unknown: Yeah, thanks, Samantha. And thanks, Yang, for your question.
We can either worked with our partners will be part of the global was contributed to the global a patient recruitment, but oh, we couldn't do a small hurdle study well they're doing the global trial. So it depends on our apartment cool wet when they go either way.
Got it and last quick question is just I know that Cyclean. Just wondering if you can provide more specifics on the agreement with a hand way and out what the terms are there.
unknown: So we do believe the mesothelioma approval is very important. And also, we're trying to get that indication approved in China as well, because it is the first validation of the tumor treating field technology outside the brain. And, you know, it really is a very strong technology validation. And, as you know, mesothelioma is also a form of lung cancer and lung disease. So we believe the success there really bodes well for the lunar trial and the current study in non-small cell lung cancer. And as you know, that's a very, very large market in China, close to 800,000 patients per year. So we really think that validation and the potential of the tumor treating field in lung cancer.
So thank you I'll turn the question to Paul.
Sure sure Mark.
Thanks for your questions or so so as we mentioned this is the you really Seattle agreement, though we are we really retain all that they've all been right regulatory right and we'll continue to be the m. at age holder, Oh, we grind exclusive promotional right who had away.
unknown: Okay, great. Thanks.
Which is one of the leading the pack as player in China. They have over 800 sales rep.
Hi, good business.
And if you think about this product it really is a wall spectrum not it validates that has a lot of you know community setting. So you really need a pretty large primary care sales force promote just kind of products. So we think this is Doug but go to market strategy versus you know building.
unknown: And my next question is about the Jula launch in China. So as I understand it, the main channel for the Jula for patients will be going through the pharmacy, right? Probably not a hospital yet. So can you tell us how many pharmacists you have already registered for the Jula? And what's your kind of year-end goal for how many pharmacists you intend to gather for the Jula by the end of this year? Thanks.
A private care field force ourselves.
Related the term I think we booked all revenue there will a we received upfront payments on milestone payments and are there will be a profit split a mechanism for their promotional effort.
unknown: Yeah, that's a very good question, and I think Jonathan has a detailed answer for you.
unknown: Yeah, yeah, thanks for that question, Yang. You're right.
[noise] got it okay. Thank you very much for taking my questions.
unknown: So the oncology products in China are, you know, the prescriptions are fulfilled at the pharmacies, but these pharmacies are also affiliated with hospitals. So what I can tell you is that, you know, when we launched Zajula and Ingman in China, we had about 150 sales FTEs dedicated to covering Zajula. For these 150 FTEs, you know, they currently cover about 800 to 900 hospitals in mainland China already. And, you know, that basically covers up to 5,000 to 6,000 physicians as well in terms of our coverage. So, you know, I think, as Samantha said, we also got onto a couple of important municipal city reimbursements, you know, while we still, you know, wait for NRDL inclusion, hopefully later this year. So, you know, we have already mobilized and have done a lot of work.
Yeah also Maureen just want to either line.
So this is our first probably care and but it's also I paid back test that's why we'd like to work with a partner on pace.
Understood understood. Thank you.
We have the next question from a line of Yang Wong from Bank of America. Please ask your question.
<unk>.
Hi, Thank you thank him for taking my question on the congratulation on all the progress.
Good to know that's ever want is doing great Oliver I'll answer My first cross channel.
I think.
Earlier in the call you've mentioned a full.
Helped to access is really important it took us a or the second indication.
My son live and ER.
I wish I have some in a into kaisa well getting lung cancer.
unknown: China. And hopefully, that gives you a bit more confidence.
Do you mind the to further elaborate on that point.
unknown: Okay, okay, great, thanks.
Sure I think you want young for joining the call and think they'll time I'll turn the question to a college.
Fei Zheng: We have the next question from the line of. Fei Zheng from Credit Suisse. Please ask your question.
Yes, Oh, Sacramento and thanks for your question. So we do believe or the middle TV old or approval. There is important and also what we're trying to get that indication in China as well because it is the first of all.
unknown: Hi, thanks for taking my questions. I have only two small questions. First one is, is there any particular reason why we have not put much effort into ZUDA in breast cancer? And my third question is, what is our focus for the in-house development products and when do we expect to see some milestones for these products? Thanks.
In addition, the tumor treating deal technology all side, the brain and it really is a very strong.
Technology about invalidation and I was you know mutual TV OMA is also a.
unknown: Thank you for the question. I think in Paul's presentation, he alluded to our expert on breast cancer. Paul, why don't you cover this question?
A form of lung cancer lung disease. So we believe the success there really bode well for the lunar trial and and current study of course on lung cancer.
unknown: Yeah, so thanks for your question. We are working, you know, very closely with our partner, GSK, on additional line extension opportunities for the ROPRIP. So we intend to work with them closely and potentially join global studies. I think breast cancer is one of the indications, not the main one.
You know got very very large market I know you know close to 800000 isn't for here.
So we really see.
Validation or the potential for treating deal in lung cancer.
Okay, great. Thanks and to my next question.
Our next question is of other juror.
Launching men in China, So yes.
unknown: Thanks.
All right and those tend to.
Main channel or for that you Oh patients will be a glance through strong pharmacy right not <unk>, probably another hospital yeah. That's okay I will tell us.
unknown: Can you give us some color on the...
unknown: Can you give us some color on the in-house development product efforts?
Many of farmer since you already answered I suppose a jewel and so what's your kind off of a you're at a goal will hold my there are falling to yours in 10 true cut this is utilizing by the handles it yeah. Thanks, Yeah. That's a very good question and I think almost done has the detailed I'm so sorry [laughter].
unknown: Yes, Samantha, you will need to take that one.
unknown: Yes, whatever, and please.
unknown: Yes, sure. Thanks for the question.
unknown: You were asking about when we are going to start hitting our milestones, and actually, this is a key year. We are targeting one to two new global INDs and the first patient dose this year, and we'll be providing more details as these IND filings proceed. And in terms of the overall strategy for our portfolio, as Samantha mentioned earlier, the types of programs that you will be seeing emerging from our internal efforts fall into three major categories: immuno-oncology, DNA damage response and repair, and oncogenic signaling. And these are the three areas that we have currently prioritized because, as you know, there's clinical validation for these three. They are synergistic with our clinical pipeline, and as Samantha mentioned, we will be exploring intra-portfolio combinations. And they are also aligned with our growing in-house expertise. So this is a way to continue to build depth and expertise in those three very key scientific areas.
Yeah.
Yeah. Thanks for that question, Yeah, Yeah, you're right so the oncology products in China.
Our prescriptions up appeal it at the pharmacies. These pharmacy. The also affiliated with the hospitals. So what I can tell you is that you know when we launched you know the jewelry in mainland China. We had about 150 cells ft dedicated to covers a jeweler well these are.
Hundred 50 ft.
You know they cover kinda only about 800 to 900 hospitals in mainland China.
Already and you got that basically covers about up to five to 6000 physicians as well it sounds about coverage. So you know I think thats I meant that said, we also got onto a couple of imports in municipal city reimbursements.
While we still going away for the an audio inclusion hopefully later this year. So you know we have already mobilized and have done a lot of was hit by the corner bars situation in China.
unknown: Okay, thanks. Thanks so much. Unsponsored ADR
And hopefully that gives you get more confidence.
Okay, Okay, great. Thanks.
unknown: We have the next question from the line of... Zhang Gao from Macquarie. Please ask your question.
[noise], we have the next question from the line up.
Gang Wang: Thanks very much for the presentation. Our company is holding up very well in the volatile market. This is Gao Xiang from Macquarie.
Hi, James from Credit Suisse. Please ask your question.
unknown: I have two questions. The first one is, What are the updates for the anti-infectives, especially for EXT2514? So is that also going to be a collaboration with the sales company? And the second question is the manufacturing of biologics, because we have quite a few drug candidates for biologics, right? So I just want to know what the plan is for the manufacturing for that category.
Hi, Thanks for taking my question my half on into small questions. First why is is there any reason why are we have not put too much effort.
For our to do that in breast cancer.
My second question is what is our focus for the in house to them in Paradise and the when we if that you see some milestones for these products. Thanks.
Oh. Thank you for the question I think because you called stuff presentation. The looted to offer export guy in the breast cancer, Tom why don't you off covered this person.
unknown: Yes, so Xiong and... That's a good question. So for the second, on the manufacturing side, we always get API supplies from a different supplier. Unsponsored ADR Because we don't feel like API is, especially for small molecule APIs, we don't see that should be one of our core expertise. But we do work with very credible suppliers. Unsponsored ADR, That is, more hospital products and also more ICU products. We do intend to commercialize that ourselves.
Yeah. So oh. Thanks for your question, we are working very closely with our partner GSK on additional line extension opportunities dropper. It so we intend to.
With that and hopefully.
Joining a mobile bodies.
I think breast cancer is one of the indication.
[noise]. Thanks.
Can't be me I'll give some color on the in house to them into a put off effort.
Oh, yes, the month, which wouldn't be to take that one.
Yeah, well era and please.
Yeah sure thing sort of the question you were asking about when are we going to start hitting milestones and actually DC sticky year. We are targeting one to two you globally and decent third patient dose DC area I wouldn't be providing more.
unknown: Okay, so for the biologics down the road, we also have to use some CMO.
unknown: For biologics, so far, the imminent one we are talking about is the PD-1 and also the Mars-2 synapse. For those, they will be imported first. Unsponsored AD
Detailed assess I'd be saying be filing proceed and Ah intensified deal their own strategy de Florida for Neil I, sometimes I mentioned earlier the types of programs that you will be seeing emerging from sometimes more fall into three major.
They've already.
Well the G DNA that makes responsibly bear and oncogenic signaling and these are the three areas that we have currently prioritized because if you know there Phoenix validation of 43, the seanergy speak with Phoenix biplane.
unknown: Okay, maybe just a follow up question very quick. Correct me if I'm wrong. I remember the Jula was actually manufactured by us, right?
unknown: Yes, it's a Zulu drug product. But again, API, we do use two suppliers, qualified local suppliers.
Yes.
Some of that mentioned, we'd be exploring interrupt portfolio combinations.
unknown: Okay, I got it. Thank you very much. Yes, thank you.
And they got to own so what language that growing in house expert T cells. This is a way to continue to be like that and expertise in those three very key scientific area.
unknown: Yeah, thank you.
unknown: We have the next question from the line of... Unsponsored ADR. Please ask your question. Oh, thanks for the question. So just two questions here.
Okay. Thanks, Thanks, so much.
So.
unknown: Can you guys just update us again on the opportunity and gist? Maybe talk a little bit about that and timing and, you know, if there's any complexities introduced from the collaboration with Decipher because of COVID-19, if there are any issues there. And then, you know, for Samantha, maybe you can talk about what you think are the kind of near and long-term structural changes from COVID-19. I know that a lot of people aren't inclined to consider potential positives coming out of this, but if there are, or if there are any silver linings that you would anticipate on a long-term basis, I would love to know if there are any of your thoughts there. Thanks so much.
We have the next question from the line of sight.
Jungle from Macquarie. Please ask your question.
Hey, Thanks, very much oh by the presentation at.
All the companies is holding out for our validating that in a volatile market Vicki galleries young from Macquarie and I have two questions. The first who aren't used.
Oh, what T. The opposite days for the end teen fabricate was especially for the X T. Two firewall for so a that's also going to be a collapse with home <unk> is that Oh its company.
And the second question is the manufacturing about logics cost we have quite a few drug candidates Oh biologics right. So I just want to know what's up to them for the manufacturing for fought for that category.
Yes, so see and Ah.
Yes, good question.
So oh, the second to Oh, the manufacturing site.
Oh, it or do a P.I. supplies from a different suppliers.
Local supplier and sometimes according to try to suppliers.
unknown: Operator, you did that.
unknown: Operator, did that go through? Oh, sorry, I muted my line. So let me hear. Thank you. I'm really sorry about the hold on.
And because we don't feel like <unk> is especially for small molecule <unk>, we don't see back 61 of our core expertise I.
unknown: And yes, with regard to reprinting, for the first one, the approval in China, we do expect to leverage the Invictus data. Unsponsored ADR, We do not expect the coronavirus will impact this product. To answer your second question, the coronavirus, I think in the short term, especially in regions affected in China, we do see some disruptions in both cells and also in clinical recruitment.
I would do work with very credible suppliers.
On the commercial activity so.
But youre talking about that posture from the license fine paces.
unknown: Unsponsored ADR Unsponsored AD
That is small hospital or products and also a mall I feel proud that we do intend to commercialize.
At our self.
[music].
Okay. So for the for the biologics down there at all what do we also got to use some C.M.O.
So biologics itself, so far we Uh huh.
The immigrants one we're talking about is the PD one and also the March two scenarios. So those they will be important first.
And then it seemed that time, usually switched to local either kunkle locally by ourselves because we do have the capability to expand our manufacturing facility.
And or we can go to a C sitting on it depends on which makes sense at the time.
Okay.
Maybe just just a follow up question Remember Creek and correct me if I'm wrong I remembered the July was.
Actually is manufactured by ourselves right.
Yes, just hula truck product, but again I want to use two suppliers qualified local suppliers.
Okay got it thank you very much.
Yeah. Thank you.
We have the next question from the line of Ah.
unknown: Thank you very much, Samantha.
Seamus Fernandez from Guggenheim.
unknown: Thank you very much.
Please ask your question.
Yigal Dov Nochomovitz: We have the next question from the line of Yigal Nochomovitz from Citigroup. Please ask your question. Oh, thanks for taking the follow up very quickly. Thanks, Samantha. Just regarding the prior question that I asked related to trial enrollment given COVID, I think you mentioned that you were in a fortunate position because one study was closed recently and another one completed recruitment in November. Could you just tell us which studies those were? Because it wasn't quite clear. Thank you.
Oh, Thanks for the question. So just two questions here can you guys just update us again on the opportunity and just maybe talk a little bit about that and timing and and you know if there's any complexities introduced or you know from the collaboration with decipher.
Because of Carbonite units or any issues there and then there for Samantha maybe you can talk about what you think are there kind of near and long term you know if there any near and long term structural changes from cobot 19, I know that a lot of people aren't.
unknown: Sure, Yigal, thanks a lot. Unsponsored ADR is the one we just closed recruitment on in November last year. It's for the first one, ovarian cancer maintenance therapy.
You know inclined to consider potential positives coming out of this but if there are oh or if there are any silver linings that that you would envision a on a long term basis loved to know <unk> if any of your thoughts there. Thanks so much.
unknown: Okay, thank you very much for clarifying.
unknown: Thank you.
Jonathan J. Wang: Once again, ladies and gentlemen, if you wish to ask a question, please press star 1 on your telephone keypad and wait for your name to be announced. Once again, ladies and gentlemen, if you wish to ask a question, please press star 1. We have the next question from the line of Jonathan Chang from SVB Lyrinc. Please ask your question.
Operator does that go through.
Oh, sorry, I knew that my life, So let me.
Thank you Oh, my goodness, sorry about the yeah hotel.
And Ah, yes that with regard to replacements for the full flying to allow the approval in China.
We do expect to Leslie you because Uh huh.
As part of our regulatory submission and that's not in the meantime way out we'll conduct a outbreak in short breaking study and will combine to stay talk to that and to a swap and did some each month.
What do not expect the condo virus billion pack on based products.
To answer your second question quantum virus I think in the short term, especially in reserve a affected in China.
unknown: Thanks for taking the follow-up. On a different topic, for MGD-013, the PD-1 lag-3 bispecific, partnered with Macrogenics, we're expecting a pretty extensive, albeit heterogeneous, update on the Phase I study at ASCO this year. Where do you think this drug is most likely to show activity?
To see some disruption seen both cells and also you couldn't called recruitment.
But having pets. So you need medium term I wish you good recovery, but in long term I think companies like US who has very strong fundamentals who are always looking for the size and the first in class a unmet medical need.
unknown: Thanks Jonathan for asking the question. I probably would like Scott to answer that question before I answer it.
And also we have a very strong cash position.
We have that's really mentioned earlier, we had more than $557 million in the back so that the without getting even stronger position to assist to not only able to that's through this stuff crisis, but also come out to be okay. That's actually a more.
unknown: Yeah, so Jonathan, I think it's probably better for Naclogenics to answer that question, but we did note in our prepared remark that we actually have a combination trial of MgD-013 and norepinephrine in gastric cancer. That's what we have so far. Okay.
He said and more thinking out of box and also had more a you know agility to adapt to global challenges.
Thanks, very much Smith.
Thank you.
We have the next question from the line of sight Yigal.
No children from Citigroup. Please ask your question.
Ying Du: Once again, ladies and gentlemen, if you wish to ask a question, please press star 1 on your telephone keypad and wait for your name to be announced. I'm showing no further questions at this time. I will now turn the call back over to Zai Lab's CEO, Samantha Du, for closing remarks.
Oh, thanks for taking the follow up very quickly. So thanks, Samantha I'm just regarding the prior question that I ask related to a trial enrollment given code that I think you mentioned.
unknown: Thank you, OpsWitcher. 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 periodically on our progress throughout the year. Operator, you may now disconnect this call.
unknown: Thank you, ma'am. Ladies and gentlemen, that does conclude our conference for today. Thank you for participating. You may all disconnect.
But you were in a fortunate position because one study was close.
Recently and another one completed recruitment in November but can you just tell us which studies those work as it wasn't quite clear. Thank you.
Sure you call thing so asking.
The one we already in the data mining and that's the states. It's the pipeline over Oh, sorry for ovarian cancer maintenance study so.
Okay and hurt the one way just close the other equipment in November last year. So the first one ovarian cancer maintenance tasks.
Okay. Thank you very much for clarifying that yep. Thank you.
[noise] once again, ladies and gentlemen, if you wish to ask a question piece press star one when your telephone keypad and Wakefield named should be announced.
unknown: Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
Once again, ladies and gentlemen.
If you wish to asked the question. Please press star one.
We have will next question from the line of ER, Jonathan Chang from a SVB.
Leerink. Please ask your question.
Hi, Thanks for taking the follow up on a different topic for N. G. D is there one three the PD one like three by specific partner with Macrogenics I, we're expecting a pretty expensive, albeit heterogeneous update on the phase ones that I get asked go this year, where do you think this.
Drug is most likely to show activity.
Hi, Thanks, Dan said, well asking the question I, probably like got lots to that question [laughter] before I'd say.
David I guess it.
Yes, the data package is coming from them and a unless that valero.
Something a bit no comment not bad calls.
Yeah, So Phil I, Jonathan I think it's probably a better for a knock wood genetics tool I sort of question, but but we didnt noted in our prepared remark about you know gosh, you had a combination trial.
Judy 13 interoperate in golf.
What we Uh huh.
Got it.
Once again, ladies and gentlemen, if you wish to asked the question. Please press star one when your telephone keypad and wait for you need to be announced.
I'm showing no further questions. This time I will now turn the call back well, but to sign labs, Oh Samantha June.
Closing remarks.
Thank you off taker.
I want to work I want.
Everyone was taken the time join us on the call today.
We appreciate the support and look forward to update you Parati Coty, Oh, my God bless throughout the year.
Operator.
You may now disconnect difficult.
Thank you maam.
Ladies and gentlemen that does conclude our conference for today. Thank you for participating you may all disconnect.
[music].