Q3 2023 FibroGen Inc Earnings Call

Yeah.

Hello.

Speaker 1: Hello.

And welcome.

Sure.

Speaker 2: to the FibroGen's third quarter 2023 earnings call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please press star one one again.

The Bible Jim's third quarter 2023 earnings calls at this time, all participants are in a listen only mode.

The speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one one on your telephone you will then hear an automated message advisers and get your hand has been raised to withdraw. Your question. Please press star. One again, please be advised that today's conference is being recorded it is now my.

Speaker 2: Please be advised that today's conference is being recorded. It is now my pleasure to introduce Vice President of Investor Relations, David DeLucia.

Pleasure to introduce vice President of Investor Relations David Delucia.

Yeah.

Good afternoon, everyone and thank you for joining today to discuss our third quarter 2023 financial and business results I'm, David de La <unk>, Vice President of corporate F. D N, a and Investor relations at fiber John joining.

Speaker 3: Good afternoon, everyone. Thank you for joining today to discuss our third quarter 2023 financial and business results. I'm David De La Chia, Vice President of Corporate FP&A and investor relations at Fighting Global.

Speaker 3: Joining me on today's call are saying we're chief executive officer. One Graham are chief financial officer. Dr. John Hunter are chief scientific officer and Chris Chung are senior vice president of China operations. Following our prepared remarks will

Joining me on today's call are thin work, our Chief Executive Officer, Juan Graham, Our Chief Financial Officer, Dr. John Hunter, Our Chief Scientific Officer, and Chris Chung, Our senior Vice President of China operations. Following our prepared remarks, we will open the call to your questions I would like to remind you that remarks made on today's call include.

Speaker 3: I would like to remind you that remarks made on today's call include forward-looking statements about fiber.

Forward looking statements about fiber Jim.

Speaker 3: Such statements may include but are not limited to our collaborations with AstraZeneca and Estellas, financial guidance, the initiation, enrollment, design, conduct and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities.

Such statements May include but are not limited to our collaborations with Astrazeneca and Astellas financial guidance. The initiation enrollment design conduct and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities.

Speaker 3: commercial results and results of operations, risks related to our business, and certain other business matters.

Commercial results and results of operations risks related to our business and certain other business matters. Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

Speaker 3: Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events that differ materially from those projected in that statement. A more complete description of these and other material risks can be found in FIBRGEN's filings with the SEC, including our most recent Form 10-K and Form 10-Q .

A complete description of these and other material risks can be found in <unk> filings with the SEC, including our most recent Form 10-K and Form 10-Q.

Speaker 3: FibreGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. The press release reporting our financial results and business update and a webcast of today's conference call can be found on the investors section of FibreGen's website at www.FibreGen.com. With that, I will turn the call over to Fain Weddick.

Five or 10 does not undertake any obligation to update publicly any forward looking statements, whether as a result of new information future events or otherwise the press release reporting our financial results and business update and a webcast of today's conference call can be found on the investors section of <unk> website at Www Dot fiber Gen Dot com.

With that I would like to turn the call over to <unk>.

Thanks, Dave and good afternoon, everyone welcome to our third quarter 2023 earnings call I would like to begin today's call by acknowledging that in November as global pancreatic cancer awareness month at a time when we reflect on the importance of raising awareness about pancreatic cancer and the need for continued research support and more effective therapies.

Speaker 3: Thanks, Dave. And good afternoon, everyone. Welcome to our third quarter 2023 earnings call. I would like to begin today's call by acknowledging that November is global pancreatic cancer Awareness Month, a time when we reflect on the importance of raising awareness about pancreatic cancer, and the need for continued research, support, and more effective therapies for this devastating disease.

This devastating disease.

Speaker 3: On today's call, I will focus our stakeholders on the four strategic pillars that will guide the company into the future, as well as provide an update on our PAM Revlimab and Roxadustat assets. Dr. John Hunter, our Chief Scientific Officer, will then review our exciting early stage oncology pipeline.

On today's call I will focus.

Our stakeholders on the four strategic pillars that will guide the company into the future as well as provide an update on our <unk> and <unk> assets, Dr. John Hunter, Our Chief Scientific Officer will then review our exciting early stage oncology pipeline last one Gram our CFO will review the financials after which we will open.

Speaker 3: Last, one gram our CFO will review the financials after which we will open the call for your question.

On the call for your questions.

Speaker 4: Starting on slide three, Fibrogen has four key strategic pillars that we believe offer significant value today. First is PAMrevelMAB with upcoming pivotal trial readouts for two pancreatic cancer indications through the first half of 2024. One readout in locally advanced disease and the other in metastatic.

Starting on slide three.

<unk> has four key strategic pillars that we believe offer significant value today.

First as Pam rebel mab with upcoming pivotal trial Readouts for two pancreatic cancer indications through the first half of 2024, one readout in locally advanced disease and the other in metastatic disease.

Speaker 4: Pancreatic cancer represents a significant commercial opportunity with substantial unmet need and PAM Revlimad has demonstrated effect in both preclinical and early clinical studies, which we will detail in a moment.

Pancreatic cancer represents a significant commercial opportunity with substantial unmet need.

<unk> has demonstrated effect in both preclinical and early clinical studies, which we will detail in a moment.

Speaker 4: Second is Roxadou Stat. Roxadou Stat is approved in over 40 countries around the world, generates significant net revenue and provides fibrigen with material and growing economics through our partnerships with AstraZeneca and Estella Sparma.

Second is <unk> <unk> is approved in over 40 countries around the world generate significant net revenue and provides <unk> with material and growing economics through our partnerships with Astrazeneca and Astellas pharma.

Speaker 4: Third is our early stage oncology pipeline. We are very excited about the potential of these programs.

Third is our early stage oncology pipeline we have.

We're very excited about the potential of these programs FG $32 46 is a first in class potent antibody drug conjugate or ADC for the treatment of metastatic castration resistant prostate cancer.

Speaker 4: FG 3246 is a first-in-class potent antibody drug conjugate or ADC for the treatment of metastatic castration resistant prostate cancer.

Speaker 4: This opportunity also includes the development of an associated pet biomarker diagnosis.

This opportunity also includes the development of an associated biomarker diagnostic.

Speaker 4: In addition to FG 3246, we were also undertaking I&D enabling activities on two innovative oncology antibodies with the intention of filing I&Ds and commencing clinical activities in 2024.

In addition to FG $32 46, we're also undertaking IND, enabling activities on two innovative oncology antibodies with the intention of filing an IND and commencing clinical activities in 2024.

Fourth is our strong cash position in the third quarter, we successfully executed on implementation of our company wide cost reduction plan now, resulting in an expected reduction of total annualized expenses of $120 million, which provides the company a bridge to achieve a number of key milestones across our.

Speaker 4: fourth is our strong cash position. In the third quarter, we successfully executed on implementation of our company-wide cost reduction plan, now resulting in an expected reduction of total annualized expenses of $120 million, which provides the company a bridge to achieve a number of key milestones across our portfolio. We have taken necessary steps to improve our financial position and will continue to focus on financial dissonance.

Folio, we have taken necessary steps to improve our financial position and we'll continue to focus on financial discipline.

Speaker 4: In summary, we believe there are few biotechnology companies of our market cap that have such a compelling mix of commercial, late stage, and early stage assets. When you combine our assets, our strong balance sheet, and the quality of our talented colleagues at Fibrogen, we believe that we have a strong foundation to drive significant shareholder value creation today and into the future.

In summary, we believe there are few biotechnology companies of our market cap and they have such a compelling mix of commercial late stage and early stage assets. When you combine our assets our strong balance sheet and the quality of our talented colleagues at <unk>. We believe that we have a strong foundation to drive significant shareholder value creation today and into the future.

<unk>.

Moving to slide five <unk> is a novel anti <unk> human monoclonal antibody in clinical development for the treatment of locally advanced unresectable pancreatic cancer or <unk> and metastatic pancreatic cancer.

Speaker 4: Moving to slide five, PAMrevimab is a novel anti-CTGF human monoclonal antibody in clinical development for the treatment of locally advanced unresectable pancreatic cancer, or LAPC, and metastatic pancreatic cancer. PAMrevimab has been studied in over 1,000 patients across various conditions, has demonstrated dose and exposure-related responses in an early-stage pancreatic cancer trial, as well as a favorable adverse event and safety profile.

<unk> has been studied in over 1000 patients across various conditions has demonstrated dose and exposure related responses in an early stage pancreatic cancer trial as well as a favorable adverse event and safety profile.

Speaker 4: On flight six and before we dive into the Pant Created Cancer Data and Opportunity, I would like to provide a recap of recently announced PemRevLMAP results. In August , we reported top-line data from our Phase III, Lelanto's two study. A placebo-controlled trial of PemRevLMAP for the treatment of ambulatory patients with DMD on background corticosteroids.

On slide six and before we dive into the pancreatic cancer data and opportunity I would like to provide a recap of recently announced <unk> results in August we reported topline data from our phase III <unk> two study a placebo controlled trial of <unk> for the treatment of ambulatory patients with DMD on background corticosteroids.

The study did not meet the primary endpoint of change in the Northstar ambulatory assessment total score from baseline to week 52.

Speaker 4: The study did not meet the primary endpoint of change in the North Star ambulatory assessment total score from baseline to week 52. Fibergium would like to thank the patients, caregivers, and clinical trial investigators for their dedication to participating in this important study, which contributes toward the understanding of this devastating disease.

Barbara Jim would like to thank the patients caregivers and clinical trial investigators for their dedication to participating in this important study, which contributes towards the understanding of this devastating disease.

Speaker 4: Looking ahead, we anticipate upcoming results from two Pam Revalenab trials in Pancreatic Cancer. We expect results from the LAPA phase three study in locally advanced disease in the first quarter of 2024. And we expect results from the Pancreatic Cancer Action Network's Precision Promise Registration Adaptive Platform trial evaluating Pam Revalenab in both first line and second line metastatic Pancreatic Cancer in the first half of 2024.

Looking ahead, we anticipate upcoming results from two <unk> trials in pancreatic cancer.

Expect results from our LAPIS phase III study in locally advanced disease in the first quarter of 2024, and we expect results from the pancreatic cancer action networks precision promise Registrational adaptive platform trial evaluating <unk> in both first line and second line metastatic pancreatic cancer in the first half of 2024.

I would now like to discuss the <unk> opportunity in pancreatic cancer in more detail starting on slide eight.

Speaker 4: I would now like to discuss the Pam Revolmapp opportunity and pancreatic cancer in more detail starting on slide 8.

Speaker 4: Pancreatic cancer represents one of the largest unmet needs in oncology with an annual incidence of nearly half a million patients across the major regions combined.

Pancreatic cancer represents one of the largest unmet needs in oncology with an annual incidence of nearly half a million patients across the major regions combined.

Speaker 4: This includes approximately 60,000 PDEC patients in the United States.

This includes approximately 60000 <unk> patients in the United States.

Speaker 4: There's an overall five year disease free survival rate of only 12.5%. And for metastatic cancer rates are as low as 3%.

There is an overall five year disease free survival rate of only 12, 5% and for medics metastatic cancer rates are as low as 3%.

On slide nine we provide an overview as to why we believe <unk> can provide benefits to patients diagnosed with pancreatic cancer.

Speaker 4: On slide nine, we provide an overview as to why we believe Pem Revolmaub can provide benefits to patients diagnosed with Pem created cancer.

Speaker 4: Based on preclinical data, CTGF plays an important role in the growth and progression of pancreatic tumor.

Based on preclinical data CTG F plays an important role in the growth and progression of pancreatic tumors.

Speaker 4: Mouse tumor studies have shown that PAMrevimab can have both direct anti-tumor effects and effects on the surrounding stroma, providing a strong clinical rationale for use in both locally advanced and metastatic pancreatic cancer.

Tumor studies have shown that <unk> can have both direct anti tumor effects and effects on the surrounding stroma, providing a strong clinical rationale for use in both locally advanced and metastatic pancreatic cancer.

Speaker 4: Given the upcoming phase three readouts, we would like to remind investors of what we believe are compelling preclinical and early clinical data that informed our decision to move PAMrevo-MAB forward in pancreatic cancer.

Given the upcoming phase III Readouts, we would like to remind investors of what we believe are compelling preclinical and early clinical data that informed our decision to move <unk> forward in pancreatic cancer.

Speaker 4: On slide 10, PAMrevalimab in combination with Jimcitabine in a KPC mouse model, slow tumor growth, decreased metastatic burden, inhibited formation of ascetes or buildup of fluid in the abdomen and substantial...

On slide 10, <unk> in combination with Gemcitabine and <unk> mouse model slowed tumor growth decreased metastatic burden inhibited formation of <unk> or buildup of fluid in the abdomen.

And substantially improved survival.

Speaker 4: On slide 11, this same mouse model also provided a mechanistic rationale for PAM Rebel Mabs beneficial effect on animal survival.

On slide 11, the same mouse model also provided a mechanistic rationale for Pam <unk> beneficial effects on animal survival.

<unk> as a monotherapy and in combination with Gemcitabine made tumor cells more susceptible to chemotherapy induced cell death, or a proptosis through quantitative reduction in X AAP.

Speaker 4: Pam Reble-Mab is a monotherapy and in combination with gymsitobene, made tumor cells more susceptible to chemotherapy and do cell death or apoptosis through quantitative reduction in XIP, a protein involved in apoptotic resistance and promotion of cell survival.

Protein involved in apoptotic resistance and promotion of cell survival.

Speaker 4: Moving to slide 12, we would like to reference the data from our open-label dose escalation phase 1, 2 trial in patients with locally advanced stage 3 or metastatic stage 4 pancreatic cancer. Most of these 75 patients were in fact metastatic and only 9 had locally advanced disease.

Moving to slide 12, we would like to reference the data from our open label dose escalation phase one two trial in patients with locally advanced stage, III or metastatic stage four pancreatic cancer.

Of these 75 patients were in fact, metastatic and only nine had locally advanced disease.

Speaker 4: Pam Reveremeb was a valued in combination with Jim Sidebeen and her low to nib as first line therapy.

<unk> was a valued in combination with gemcitabine and our low to nib as first line therapy.

Speaker 4: An important observation in the study was that clinical benefit was observed at higher drug exposure level.

An important observation in the study was a clinical benefit was observed at higher drug exposure levels. Once drug plasma levels reached a trough threshold of 150 microgram micrograms per ml a number of important results were found most notable result in this study was that one year survival was 37% for patients.

Speaker 4: Once drug plasma levels reached a trough threshold of 150 micrograms per ml, a number of important results were found. The most notable result in this study was that one year survival was 37% for patients who had circulating comorbidum levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels.

Who had circulating <unk> levels of 150 micrograms per ml or higher versus 11% for those with lower plasma levels.

Speaker 4: These results in the higher dose cohort patients with plasma drug levels above the 150 micrograms for M-L threshold included improved median overall survival and improved median progression free survival.

These results in the higher dose cohort patients with plasma drug levels above the 150 micrograms per ml threshold included improved median overall survival and improved median progression free survival.

Speaker 4: Moving to slide 13, pivotal trials are being conducted with PAM-revel-MAB in both locally advanced and metastatic patients.

Moving to slide 13 pivotal trials are being conducted with <unk> in both locally advanced and metastatic patients.

These patients represent almost 90% of all diagnosed pancreatic cancer patients today.

Speaker 4: These patients represent almost 90% of all diagnosed pancreatic cancer patients today, giving Pabrevimab a potential opportunity to treat a vast majority of patients across this devastating disease.

Pat rebel mab potential opportunity to treat a vast majority of patients across this devastating disease.

Speaker 4: On slide 14, we provide an overview of the Global Phase 3 LAPAS trial, a double blind placebo controlled trial and 284 patients would locally advanced unresectable pancreatic cancer, comparing PEM Rebellmab to placebo in combination with standard of care chemotherapy. The primary endpoint is overall survival, and we expect top line data from the study in the first quarter of next year.

On slide 14, we provide an overview of the global phase III LAPIS trial, a double blind placebo controlled trial in 284 patients with locally advanced Unresectable pancreatic cancer, comparing <unk> to placebo in combination with standard of care chemotherapy.

The primary endpoint is overall survival and we expect topline data from this study in the first quarter of next year.

Speaker 4: On slide 15 is an overview of the pancreatic cancer action network's precision promise trial.

On slide 15 is an overview of the pancreatic cancer action networks precision promise trial.

Speaker 4: This is a Phase 2, 3 Registration Study that is being executed at the top pancreatic centers in the United States.

This is a phase III Registrational study that is being executed at the top pancreatic centers.

In the United States.

Speaker 4: Like the lapis trial and locally advanced disease, the primary endpoint of the precision promise trial is overall survival.

Like the LAPIS trial in locally advanced disease. The primary endpoint of the precision promise trial is overall survival.

Speaker 4: Pomerelmab is being evaluated in both first and second line therapy for metastatic disease and was the first experimental treatment arm in the precision PROMIS platform trial to be evaluated in the first...

<unk> is being evaluated in both first and second line therapy for metastatic disease and was the first experimental treatment arm and the precision promise platform trial to be evaluated.

In the first line metastatic setting.

Speaker 4: Moving to slide 16, we show a snapshot of both PAM Rebel Mab Registrational Face Restudies. One important difference between the two studies is the dosing regimen of the precision promise study.

Moving to slide 16.

We show a snapshot about <unk> Registrational phase III studies, one important difference between the two studies is the dosing regimen to the precision promise study.

Speaker 4: PembrevoMab is dosed in 28 day treatment cycles until progression or discontinuation, which is distinct from lapis in which PembrevoMab was delivered in a neoagement setting, and where it was dosed for up to six months.

<unk> is dosed in 28 day treatment cycles until progression or discontinuation, which is distinct from LAPIS and which Pam rebel Mab was delivered in the neo adjuvant setting and where it was dose for up to six months, we believe the ability to dose patients until disease progression in the metastatic setting provides the potential opportunity to amplify.

Speaker 4: We believe the ability to dose patients until disease progression in the metastatic setting provides a potential opportunity to amplify clinically meaningful increases in overall survival driven by those patients benefiting from PEM RevolMab treatment.

Clinically meaningful increases in overall survival driven by those patients benefiting from Pam rebel mab treatment.

On Slide 17, we review the U S commercial opportunity for <unk> in pancreatic cancer.

Speaker 4: On slide 17, we review the U.S. commercial opportunity for PEM rebel map and pancreatic cancer.

Speaker 4: There have been limited treatment advances over the last two decades, and both locally advanced and metastatic diseases, with immuno-oncology therapies providing benefit to a small subset of metastatic patients.

<unk> been limited treatment advances over the last two decades in both locally advanced and metastatic diseases with <unk>.

Immuno oncology therapies, providing benefit to a small subset of metastatic patients using.

Speaker 4: Using straightforward assumptions, the total addressable market for pancreatic cancer in the US is a multi-billion dollar commercial opportunity for Palm Revolmaab, if it can demonstrate a significant improvement in overall survival, in either locally advanced or metastatic patients.

Using straightforward assumptions the total addressable market for pancreatic cancer in the U S is a multibillion dollar commercial opportunity for <unk> epic and demonstrate a significant improvement in overall survival and either locally advanced or metastatic patients in.

Speaker 4: In fact, Medesthetic Pancreatic Cancer alone represents a larger market opportunity in the US for Pam Revolmaub than we were forecasting for IPF.

Metastatic pancreatic cancer alone represents a larger market opportunity in the U S for <unk> than we were forecasting for IPF.

Speaker 4: Moving on to Roxadoo Set on slide 19, I would like to provide a recap of recently announced Roxadoo Set results, as well as review.

Moving on to <unk> on Slide 19, I would like to provide a recap of our recently announced <unk> results.

As well as review our upcoming milestones.

Speaker 4: In May, we announced positive top line data from our Phase III clinical study of Roxidoust app for the treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignant season China.

In May we announced positive top line data from our phase III clinical study of <unk> for the treatment of anemia in patients receiving concurrent chemotherapy treatment for non myeloid malignancies in China.

<unk> demonstrated non inferiority compared to recombinant erythropoietin alpha on the primary endpoint of change in hemoglobin level from baseline to the average level during weeks nine through 12.

Speaker 4: Rocks to do stat demonstrated non-apariori compared to recombinant erythropoitin alpha on the primary endpoint of change in hemoglobin level from baseline to the average level during which 9 through 12.

Speaker 4: These data were recently presented in an oral presentation at the Eismo Congress 2023 in Madrid on October 21st.

These data were recently presented in an oral presentation at the ESMO Congress 2023, and Madrid on October 21.

Speaker 4: I'm excited to announce that in July are supplemental new drug application or SNDA for rocks to do stat in patients with chemotherapy in the city media has been accepted by the China health authority and we continue to expect an approval decision in mid 2024. Upon approval. Fibergen will receive a milestone payment from AstraZeneca. We believe this indication could represent a meaningful incremental net revenue opportunity on top of the enemy of CKD indication.

I am excited to announce that in July our supplemental new drug application or NDA for <unk> in patients with chemotherapy induced anemia has been accepted by the China Health Authority and we continue to expect an approval decision in mid 2024.

Upon approval fiber general receive a milestone payment from Astrazeneca. We believe this indication could represent a meaningful incremental net revenue opportunity on top of the anemia of <unk> indication.

Speaker 4: Moving now to slide 20, Roxyducedap for anemia of chronic kidney disease continues to perform extremely well in China.

Moving now to slide 20, <unk> for anemia of chronic kidney disease continues to perform extremely well in China.

Speaker 4: Third quarter total rocks had to set net sales in China by 5 origin and the distribution entity jointly owned by 5 origin and AstraZeneca was $77.1 million compared to 59 million dollars in the third quarter of 2022 and increase of 31%. This growth was driven by an increase in volume of 37%

Third quarter total <unk> reduced that net sales in China by fiber gin and the distribution entity jointly owned by <unk> and Astrazeneca was $77 1 million compared to $59 million in the third quarter of 2022.

An increase of 31% this growth was driven by an increase in volume of 37%.

Speaker 4: Fibergine's portion of rocks introduced at net product revenue in China was 29.4 million dollars for the third quarter on a US gap basis Compared to 17.4 million dollars in the third quarter of 2022 and increase of 69%

<unk> portion of <unk> net product revenue in China was $29 4 million for the third quarter on a U S GAAP basis compared to $17 4 million in the third quarter of 2022, an increase of 69%.

Speaker 4: Moving to slide 21, Roxadoucet continues to expand its category leadership and brand value share in China. Rise into 42% in the most recent three-month period ending in August of 2023.

Moving to slide 21, <unk> reduced that continues to expand its category leadership and brand value share in China.

Rising to 42% in the most recent three month period ending in August of 2023.

Speaker 4: The potential addition of the chemotherapy induced andemia indication would create an additional catalyst to both continued share and volume growth of Roxas duestad in China.

The potential addition of the chemotherapy induced anemia indication would create an additional catalyst to both continued share and volume growth of <unk> in China.

Speaker 4: Given that there have been several generic applications filed in China, I would like to briefly touch on the generic market more broadly in China and the exclusivity of Roxadoo's dad.

Given that there had been several generic applications filed in China, I would like to briefly touch on the generic market more broadly in China and the exclusivity of <unk>.

Speaker 4: The impact of a generic approval in launch in China is meaningfully different than in the US market.

The impact of a generic approval and launch in China is meaningfully different than in the U S market.

Speaker 4: Generate players face lead time and execution risk of market adoption after approval, as they need to be admitted into individual hospital formularies one at a time.

Generic players space lead time and execution risk of market adoption after approval as they need to be admitted into individual hospital formularies one at a time.

Speaker 4: Originator products do not experience a meaningful deterioration in business until at least four or more generic products are approved.

Originated products did not experience a meaningful deterioration in business until at least four or more generic products are approved.

Speaker 4: Even then, originator products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market. Our composition of matter patents expire in June of 2024 and we do not expect meaningful deterioration of the rocks to do that business in the near term.

Even then originator products in China have historically been able to maintain a stream of net revenues and profits after generics enter the market.

Our composition of matter patents expire in June of 2024, and we do not expect meaningful deterioration of the rocks just that business in the near term.

Speaker 4: In addition to the continued outstanding performance of Roxadou State and China, the Roxadou State launch in Europe is accelerating, showing robust quarter-over-quarter growth. We expect this growth to continue to accelerate, given the strong competitive position of Roxadou State.

In addition to the continued outstanding performance of <unk> in China. The rocks just at launch in Europe is accelerating showing robust quarter over quarter growth.

We expect this growth to continue to accelerate given the strong competitive position of <unk>.

Speaker 4: Roxyducedestest is the only HIF PHI indicated in the EU for the treatment of anemia of CKD in both non-diallysis and dialysis patients. And with GSK's decision to withdraw the MAA for debt-produced debt, combined with market exclusivity for Roxyducedestest beyond 2030, Roxyducedestest is well positioned to continue its growth and market leadership throughout this decade.

<unk> is the only hip ph I indicated in the EU for the treatment of anemia of <unk> in both non dialysis and dialysis patients and with Gsk's decision to withdraw the MAA for debt reduce debt combined with market exclusivity for <unk> beyond 2030, <unk> is well positioned to continue to grow.

<unk> and market leadership throughout this decade.

Speaker 4: I will now hand it off to John Hunter, our CSO, to cover our early-stage pipeline. John ? Thank you, Shane.

I will now hand, it off to John Hunter, our CSO to cover our early stage pipeline John.

<unk>.

Speaker 2: Moving to slide 23, we have a snapshot of our early stage oncology pipeline programs that are currently in the clinic or at later stages of non clinical development.

Moving to slide 23, we have a snapshot of our early stage oncology pipeline programs that are currently in the clinic or at later stages of non clinical development.

Speaker 5: On slide 24 is an overview of the exclusive license deal that we entered into with Fortis in Q2 of this year for 446, now called FG3246.

On slide 24 is an overview of the exclusive license deal that we entered into with <unk> in Q2 of this year for 446 now called FTE $32 46.

Speaker 5: FG3246 is a potential first-in-class antibody drug conjugate, or ADC, for metastatic castration, resistant prostate cancer, colorectal cancer, and other tumor types.

FTE 30 to 46 as a potential first in class antibody drug conjugate or ADC for metastatic castration resistant prostate cancer colorectal cancer and other tumor types.

Speaker 5: FT3246 binds to a cell receptor target that internalizes upon antibody binding and is present at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate.

FTE $32 46 binds to a cell receptor target that internalizes upon antibody binding and as president at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidates.

Speaker 5: Moving to slide 25. FG 3246 is comprised of an anti-CD 46 antibody, YS5 linked to the anti-mitotic agent MMAE, which is a clinically and commercially validated ADC payload.

Moving to slide 25.

<unk> $32 46 is comprised of an anti CD 46 antibody y S. Five linked to the anti mitotic agent MMA, which is a clinically and commercially validated ADC payload.

Speaker 5: FG3246 is demonstrated efficacy against CD46 expressing tumors in both preclinical and clinical studies. The associated PET imaging biomarker, PET46, utilizes the same targeting antibody as FG3246 and is under development at UCSF.

Ft $32 46 has demonstrated efficacy against CD 46, expressing tumors in both preclinical and clinical studies.

The associated pet imaging biomarker pet 46 utilizes the same targeting antibody as FTE $32 46 and is under development at UCSF.

Speaker 5: It is comprised of the YS5 antibody coupled to the radionuclide zirconium-89, and in preclinical studies demonstrates specific targeting of and uptake by CD46 positive tumors. We plan to explore its potential for use in identifying FG3246 responsive patients in a phase two trial that is described on slide 27.

It is comprised of the <unk> five antibody coupled to the radionuclide zirconium 89 and in preclinical studies demonstrate specific targeting of an uptake by CD 46 positive tumors, we plan to explore its potential for use in identifying FTE $32 46 responsive patients in a phase <unk>.

<unk> trial that is described on slide 27.

Speaker 5: Moving to slide 26. As we noted in our last earnings call, FK3246 has demonstrated monotherapy, clinical efficacy in multiple myeloma and metastatic castration resistant prostate cancer.

Moving to slide 26, as we noted in our last earnings call <unk> $32 46 has demonstrated monotherapy clinical efficacy in multiple myeloma in metastatic castration resistant prostate cancer.

Speaker 5: Interim data from, excuse me, from the ongoing phase one trial and prostate cancer showed that four out of 21 valuable patients had partial responses based on resist criteria at the two highest study doses and an overall PSA 50 response rate of 45% in heavily pre-treated patients who had a median of five prior therapies.

Interim data from excuse me from the ongoing phase one trial in prostate cancer showed that four out of 21 Evaluable patients had partial responses based on resist criteria at the two highest studied doses and an overall PSA 50 response rate of 45% in heavily pretreated patients who had a median of.

Five prior therapies the.

Speaker 5: The safety profile for FG-3246 was consistent with other MMAE-based ADC therapeutics with neutropenia being the most common adverse event.

The safety profile for FTE $32 46 was consistent with other MMA based ADC therapeutics with neutropenia being the most common adverse event.

Speaker 5: updated data from the trial will be reported upon study completion projected for Q1 2024.

Updated data from the trial will be reported upon study completion projected for Q1 2024.

Speaker 5: On slide 27, we show ongoing and planned clinical trials for FG-3246.

On slide 27, we show ongoing and planned clinical trials for FTE $32 46.

Speaker 5: In addition to the Phase I Dose Sesthalation and Expansion Study referenced on the previous slide, there is also a combination study with Enzoludomide that is currently being run at UCSF.

In addition to the phase one dose escalation and expansion study referenced on the previous slide. There is also a combination study with <unk> that is currently being run at UCSF. The.

Speaker 5: The rationale for this combination is based on pre-clinical data demonstrating up regulation of CD46 and tumor cells following Enzoludomide treatment. Therefore, potentially making them more responsive to treatment with FG3246.

The rationale for this combination is based on preclinical data demonstrating upregulation of <unk> 46 in tumor cells following <unk> treatment.

Therefore, potentially making them more responsive to treatment with FG $32 46.

Speaker 5: Initial data from this trial is expected in the second half of 2024.

Initial data from this trial is expected in the second half of 2024.

Speaker 5: A trial for the PET-46 biomarker and prostate cancer is in progress at UCSF.

A trial for the pet 46 biomarker in prostate cancer is in progress at UCSF.

Speaker 5: The goal is to develop a screening assay to select patients with high CD46 expression, who are most likely to benefit from treatment with FG3246.

Our goal is to develop a screening assay to select patients with high <unk> 46 expression, who are most likely to benefit from treatment with FG $32 46.

Speaker 5: This biomarker will be part of a Phase II study run by Fibrogen in which up to 100 patients will be enrolled following a PET scan with PET-46.

This biomarker will be part of a phase two study run by fiber Jen and which up to 100 patients will be enrolled following a pet scan with pet 46 pay.

Speaker 5: Patients will not be stratified at the start of the study, but the correlation between pet positivity and FG 32, 32, 46 efficacy will be assessed at the end of the study with the potential to use the pet 46 biomarker to stratify patients in a pivotal phase three trial. We anticipate the initiation of the phase two trial in metastatic castration resistant prostate cancer in the second half of 2024.

Patients will not be stratified at the start of the study, but the correlation between pet positivity in FTE 30 to $32 46 efficacy will be assessed at the end of the study with the potential to use the pet 46 biomarker to stratify patients in a pivotal phase III trial we.

We anticipate the initiation of the phase II trial in metastatic castration resistant prostate cancer in the second half of 2024.

Speaker 5: Moving to slide 28, I would like to briefly cover our pre-clinical oncology pipeline. The pipeline includes two amino oncology antibody programs, one targeting the lectinine or gal-9, and the other targeting the CCRA G-protein coupled receptor.

Moving to slide 28, I would like to briefly cover our preclinical oncology pipeline.

The pipeline includes two immuno oncology antibody programs, one targeting the lectin nine a gallon nine and the other targeting the CCR eight G protein coupled receptor.

Speaker 5: FG3165 is an anti-GAL9 antibody developed to reverse immune resistance in solid tumors.

FTE 31, 65 is an anti <unk> antibody developed to reverse immune resistance in solid tumors.

Speaker 5: GAL-9 is a soluble, immunospressive molecule that is over-expressed in many tumor indications and that has been implicated in maintaining an immune suppressed tumor microenvironment.

<unk> nine is a soluble immuno suppressive molecule that is over expressed in many tumor indications and that has been implicated in maintaining an immune suppressive tumor microenvironment.

Speaker 5: FG3165 has been shown pre-clinically to reverse multiple gal-9 mediated mechanisms of immune suppression, including prevention of gal-9 mediated effector T cell apoptosis.

FG $31 65, it's been shown in preclinical either reverse multiple <unk> mediated mechanisms of immune suppression.

<unk> prevention of gallon nine mediated effector T cell apoptosis reversal of gallon nine mediated signaling in T cells and disruption of dimerization of immune checkpoints, Tim three and Mr. <unk>.

Speaker 5: reversal of gal 9 mediated signaling in T cells and disruption of dimerization of the immune checkpoints TEM3 and Vista.

Speaker 5: This data was presented at the Society for Immunotherapy and Cancer Annual Meeting this past weekend, and the poster will be available on our website.

This data was presented at the society for immunotherapy and cancer annual meeting this past weekend and the poster will be available on our website.

Speaker 5: We are working towards a Q1 2024 IND filing for this program. Moving to our...

We are working towards a Q1 2020 for IND filing for this program.

Moving to our <unk> program.

Speaker 5: CCRA is a receptor that is highly expressed on tumor infiltrating p-regulatory cells, known as t-regs, with very limited expression outside of the tumor microenvironment.

<unk> is a receptor that is highly expressed on tumor infiltrating T regulatory cells known as T regs with very limited expression outside of the tumor microenvironment.

Speaker 5: Antibody-mediated depletion of CCR8 positive Tregs results in potent antitumor effects in preclinical tumor models.

Antibody mediated depletion of <unk> positive T regs results and potent anti tumor effects in preclinical tumor models.

Speaker 5: FG3175 is an anti-CCR8 antibody designed to selectively disrupt and deplete T-regs in the tumor microenvironment without affecting peripheral T-regulatory cells.

Ft 31, 75 is an anti <unk> antibody designed to selectively disrupt and deplete T regs in the tumor microenvironment without affecting peripheral T regulatory cells.

Speaker 5: Given its highly specific targeting of Tregs in the tumor microenvironment, we see FG3175 as having broad therapeutic potential in solid tumors. I will now turn the call over to Juan to discuss the company's financial.

Given its highly specific targeting of T. Regs in the tumor microenvironment, we see FTE 31, 75 is having broad therapeutic potential in solid tumors I.

I will now turn the call over to Juan to discuss the Companys financial.

Thank you John.

Speaker 3: Before jumping into the financial update, I would like to spend a moment to acknowledge and thank our Fivergen colleagues around the world.

Before jumping into the financial update I would like to spend a moment to acknowledge and thank our fiber Jim colleagues around the world.

Speaker 3: I'm continuously inspired by many interactions with our team in which I see tremendous resilience, positive mindset, and exceptional operational capability that enables us to deliver on key clinical, operational and financial milestones. Now diving into these.

I am continually inspired by many interactions with our team and which I see tremendous resilience positive mindset and exceptional operational capability that enables us to deliver on key clinical operational and financial milestones.

Now diving into these quarters financial results.

Speaker 3: For the third quarter of 2023, total revenue was $40.1 million compared to $15.7 million for this same period in 2022. A robust increase of 155% year-to-year. This significant growth showcases the strength of our business. I will now-

For the third quarter of 2023 total revenue was $40 1 million compared to $15 7 million for the same period in 2022.

A robust increase of 155% year over year.

This significant growth showcases the strength of our business I.

I will now provide further texture on our revenue.

Speaker 3: As of Q3 2023, we recorded $29.4 million of net product revenue for Roxy Dusted sales in China, compared to $17.4 million in the third quarter of 2022, representing an increase of 69% year-over-year and highlighting the strong performance of Roxy Dusted in China.

As of Q3 2023, we recorded $29 4 million of net product revenue for <unk> sales in China compared to $17 $4 million in the third quarter of 2022, representing.

Representing an increase of 69% year over year and highlighting the strong performance of <unk> in China.

Speaker 3: During the third quarter, we recorded $6.8 million as development revenue associated with co-development efforts for Roxadousted with our partners as compared to $2.5 million during the third quarter of 2022.

During the third quarter, we recorded $6 8 million as development revenue associated with co development efforts for <unk> with our partners as compared to $2 $5 million during the third quarter of 2022 for.

Speaker 3: For the 4th quarter, and as we have previously guided, we expect co development revenue to range from 3 to 5Million dollars.

For the fourth quarter and as we have previously guided we expect co development revenue to range from $3 million to $5 million.

Speaker 3: In the third quarter, due to the successful completion of post-approval safety studies associated with Roxidu's study in China, we triggered a $4 million milestone payment from AstraZeneca.

In the third quarter due to the successful completion of post approval safety studies associated with <unk> in China, we triggered a $4 million milestone payment from Astrazeneca too.

Speaker 6: $2.6 million of this milestone was recognized as license revenue, $0.9 million was recognized as co-development revenue, and the remainder is classified as deferred revenue.

$2 6 million of this milestone was recognized as license revenue <unk> $9 million was recognized as co development revenue and the remainder is classified as deferred revenue.

Finally in the third quarter, we also recorded $1 $3 million in drug product revenue for <unk> bulk drug product or active pharmaceutical ingredients sold to our partner Astellas.

Speaker 6: Finally, in the third quarter, we also recorded $1.3 million in drug product revenue for Ruxa DuSET, bulk drug product, or active pharmaceutical ingredients sold to our partner Estella.

Speaker 6: I will now move to provide further detail on our financial performance in China.

I will now move to provide further detail on our financial performance in China.

Speaker 6: As previously mentioned by Thane, total Ruxedust net sales for the joint distribution entity or JDE owned by AstraZeneca and Fibergent was $77.1 million this quarter compared to $59 million in the third quarter of 2022.

As previously mentioned by <unk> total <unk> reduced our net sales for the joint distribution entity or J D E owned by Astrazeneca and fiber Jim.

$77 $1 million this quarter compared to $59 million in the third quarter of 2022.

Speaker 6: As substantial increase of 31% year-over-year, highlighting the continued strong performance of the Averinso franchise in China, while also achieving our highest value share since launch at 42% of the category.

A substantial increase of 31% year over year, highlighting the continued strong performance of the <unk> franchise in China, while also achieving our highest value share since launch at 42% of the category.

Speaker 6: From total ROXADUSTAT net sales in China, Fivergen's net transfer price from sales to the JDE was $24.2 million for the third quarter compared to $19.5 million in the third quarter of 2022, an increase of 24% year over year. Net transfer price is the best reflection of Fivergen's portion of the cash received by ROXADUSTAT in China.

From total <unk> net sales in China fiber Jensen that transfer price from sales to the JV was $24 2 million for the third quarter compared to $19 $5 million in the third quarter of 2022.

An increase of 24% year over year.

That transfer price is the best reflection of fiber <unk> portion of the cash received by <unk> in China.

During this quarter, we also released $2 3 million from deferred revenue.

Speaker 6: During this quarter, we also released $2.3 million from the FURD revenue.

Speaker 6: As a result, Fibergene recorded $26.5 million in net revenue for the quarter from Ruxedousted sales to the JD and $2.9 million of direct to the distributor sales from Fibergene China. Totaling $29.4 million in a US gap base.

As a result fiber Gen recorded $26 5 million and net revenue for the quarter from <unk> sales to the JV and $2 9 million of direct to distributor sales from fibers in China.

Totaling $29 4 million.

U S GAAP basis.

Speaker 6: Our revenue growth highlights the continued robustness in execution and physician and patient adoption of Ruxidustat in China.

Our revenue growth highlights the continuous through continued robustness in execution and physician and patient adoption of <unk> in China.

Speaker 6: Now moving down the income statement are operating costs and expenses for the third quarter of 2023 where 103.6 million dollars compared to 109.4 million dollars for the third quarter of 2022. A decrease of 5.8 million dollars year over year.

Now moving down the income statement, our operating costs and expenses for the third quarter of 2023 were $103 $6 million compared to $109 4 million for the third quarter of 2022.

A decrease of $5 $8 million year over year.

Speaker 6: It is worth noting that this quarter's operating expenses include a $12.6 million restructuring charge related to a reduction in force during the third quarter.

It is worth noting that this quarters operating expenses include a $12 6 million restructuring charge related to a reduction in force during the third quarter.

R&D expenses for the third quarter of 2023 were $61 2 million compared to $75 $2 million into third quarter of 2022.

Speaker 6: The reduction in R&D expenses is primarily attributable to the shutdown of our late-stage trials in pemreblumab, as well as the reduction of U.S. R&D headcount.

The reduction in R&D expenses is primarily attributable to the shutdown of our late stage trials in <unk> as well as the reduction of U S. R&D head count.

Speaker 6: Of the $61.2 million in R&D expenses, approximately 45% was related to Pemrevla map, 40% allocated to support our early stage pipeline, and the remaining 15% directed towards Ruxedusta development activities in the U.S. and China.

Of the $61 $2 million in R&D expenses, approximately 45% was related to Perm revenue map, 40% allocated to support our early stage pipeline and the remaining 15% directed towards <unk> development activities in the U S and China.

Speaker 6: SG&A expenses for the third quarter of 2023 were $25.6 million compared to $29.9 million in the third quarter of 2022, a decrease of $4.3 million year-over-year. The reduction in SG&A expenses is primarily attributable to reduced infrastructure costs, as well as the reduction of U.S. SG&A headcount.

SG&A expenses for the third quarter of 2023 were $25 6 million compared to $29 9 million in the third quarter of 2022.

Decrease of $4 $3 million year over year.

The reduction in SG&A expenses is primarily attributable to reduced infrastructure costs as well as the reduction of U S. SG&A head count.

Speaker 6: During the third quarter of 2023, we recorded a net loss of $63.6 million or $0.65 net loss for both basic and diluted share as compared to a net loss of $91.7 million or $0.98 per basic and diluted share for the third quarter of 2022.

During the third quarter of 2023, we recorded a net loss of $63 6 million or <unk> 65, net loss per both basic and diluted share as compared to a net loss of $91 7 million or <unk> 98 per basic and diluted share for the third quarter of 2022.

Speaker 6: The impact of the above mentioned restructuring charge of $12.6 million related to the reduction in U.S. workforce represent approximately 13 cents loss per both basic and the loaded share.

The impact of the above mentioned restructuring charge of $12 $6 million related to the reduction in U S workforce represents approximately 13%.

Loss per both basic and diluted share.

Speaker 6: On slide 30, we highlight our performance against our prior savings guidance.

On slide 30, we highlight our performance against our prior savings guidance.

Speaker 6: I am pleased to announce an improvement in our expected savings to be in the upper range of our previously communicated guidance of 100

I am pleased to announce an improvement in our expected savings to be in the upper range of our previously communicated guidance of 100.

Colors.

Speaker 6: We are now forecasting a reduction of approximately 120 million dollars in total annualized expenses, which roughly translates to around 30 million dollars per quarter.

We are now forecasting a reduction of approximately $120 million in total annualized expenses, which roughly translates to around $30 million per quarter.

Speaker 6: After adjusting for one time charges in the third quarter, we achieved over 60% of our total expected savings this quarter, versus expected savings of approximately 20% that we communicated during our second quarter update.

After adjusting for one time charges in the third quarter, we achieved over 60% of our total expected savings this quarter versus expected savings of approximately 20% that we communicated.

During our second quarter update.

Speaker 6: We now expect to achieve 75 to 85% of our quarterly savings in the fourth quarter of 2023, and deliver on our quarterly expected run rate savings of $30 million in the first quarter of 2024.

We now expect to achieve 75% to 85% of our <unk>.

<unk> savings in the fourth quarter of 2023 and deliver on our quarterly expected run rate savings of $30 million in the first quarter of 2024.

Speaker 6: Now shifting towards cash of September 30th, we reported $283 million in cash, cash equivalence, investments, and accounts receivable.

Now shifting towards cash.

At September 30, we reported $283 million in cash cash equivalents investments and accounts receivable.

Speaker 6: Our cash balance reflects the change of $78.1 million versus a prior quarter, which captures a variety of one-time cash outflows such as a $14.1 million historical co-promotion expense in China, severance payments, as well as clinical trials shut down costs, which increased our cash utilization in the quarter.

Our cash balance reflects the change of $78 $1 million versus the prior quarter, which captures a variety of one time cash outflows such as a $14 1 million historical co promotion expense in China severance payments as well as clinical trials shutdown costs, which increased our cash utilized.

<unk> in the quarter.

Speaker 6: As we move forward, we expect our cash burn rate to reflect the reduction in our trading expenses, and we expect fourth quarter cash burn to be substantially lower.

As we move forward, we expect our cash burn rate to reflect the reduction in operating expenses and we expect fourth quarter cash burn to be substantially lower.

Speaker 6: With a reduction in operating expenses and maintaining a discipline capital allocation approach as previously communicated we expect our cash cash equivalents investments and accounts receivable to be sufficient to fund our operating plans into 2026. Thank you and now would

With the reduction in operating expenses and maintaining a disciplined capital allocation approach as previously communicated we expect our cash cash equivalents investments and accounts receivable to be sufficient to fund our operating plan into 2026.

Thank you and now I would like to turn the call back over to Frank.

Speaker 4: Thanks, Juan. In closing, we are excited about our near-term prospects and the value they provide to stakeholders. To recap, we expect top-line data from the following two PEM Rebellum App Pivotal Studies.

Thanks, Juan in closing we are excited about our near term prospects and the value they provide to stakeholders to recap we expect top line data from the following two <unk> pivotal studies are.

Speaker 4: Our Phase III Lapis trial and locally advanced pancreatic cancer in the first quarter of 2024. And the Phase II III pancreatic cancer action network precision promise trial and metastatic pancreatic cancer in the first half of 2024.

Our phase III <unk> trial in locally advanced pancreatic cancer in the first quarter of 2024, and the phase III <unk> III pancreatic cancer action network.

Precision promise trial in metastatic pancreatic cancer in the first half of 2024.

Speaker 4: Rocks DuStack continues to perform very well in China, where our S&DA has been accepted for the chemotherapy induced anemia indication, and our partner Estellus continues with the commercialization of Rocks DuStack in Europe , Japan, and other markets.

<unk> continues to perform very well in China, where our <unk> has been accepted for the chemotherapy induced anemia indication and our partner Astellas continues with the commercialization of <unk> in Europe, Japan and other markets.

Speaker 4: In our early stage pipeline, we expect top line results from the Phase I Mono Therapy trial of FG3246, a first in class antibody drug conjugate targeting a novel epitote on CD46 for metastatic castration resistant prostate cancer by the first quarter 2024 and anticipate the initiation of a Phase II trial in MCRPC in the second half of 2024.

In our early stage pipeline, we expect topline results from the phase one monotherapy trial of FG $32 46, a first in class antibody drug conjugate targeting a novel epitope on <unk> 46 for metastatic castration resistant prostate cancer by the first quarter 2024, and anticipate the initiation of a <unk>.

<unk> II trial NMC RPC in the second half of 2024, we.

Speaker 4: We anticipate filing an I&D for FG 31 65 hour anti-gallonine antibody in the first quarter of 2024. We anticipate filing an I&D for FG 31 75 our anti CCRA antibody in the second half of 2024. And we have a strong balance sheet and expect our current cash position is one said the fund operations into 2026.

We anticipate filing an IND for FG $31 65, our anti <unk> antibody in the first quarter of 2024.

We anticipate filing an IND.

For FG 3175, our anti <unk> antibody in the second half of 2024.

And we have a strong balance sheet and expect our current cash position is one said to fund operations into 2026.

Speaker 4: In summary, we will continue to execute against our strategic priorities. As we strive to attain evaluation, that we believe is more reflective of our current and future rocks to do set revenue stream, near-term pound rebel map readouts and pancreatic cancer, our early stage pipeline, and our strong balance sheet.

In summary, we will continue to execute against our strategic priorities as we strive to attain a valuation that we believe is more reflective of our current and future rock should use that revenue stream near term Pam <unk> readouts in pancreatic cancer, our early stage pipeline and our strong balance sheet.

Speaker 4: I would like to thank all the employees of Fibergine for their continued hard work and perseverance over the last few months.

I'd like to thank all the employees of fiber Gen for their continued hard work and perseverance over the last few months.

Speaker 4: I would now like to turn the call over to the operator for Q&A.

I'd now like to turn the call over to the operator for Q&A.

Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced towards draw. Your question. Please press star one again.

Speaker 2: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced.

Speaker 2: So with your question, please press star 11 again.

And our first question comes from the line of Paul Choi with Goldman Sachs.

Speaker 2: And our first question comes from the line of Paul Choi with Goldman Sachs.

Hi, there.

Speaker 7: I was muted there. Just a little calling for Paul. Thank you so much for seeing our questions. I guess I have a couple of questions. So with regard to Roku, do set in China, could you please provide some additional color on one year expectations when you might start to see an eventual impact from generic competition beyond next year in terms of either pricing or market share and then to give in the idiosyncrasies of China that you mentioned. How does that really affect the company's strategy in mitigating such an eventual impact from potential generic?

This is <unk>, calling in for Paul. Thank you so much for taking our questions I guess.

I have a couple of quick questions. So with regard to Roku set in China could you. Please provide some additional color on one your expectations. When you might start to see an eventual impact from generic competition beyond next year in terms of either pricing or market share and then two given the idiosyncrasies of China that you mentioned.

How does that really affect the company strategy and mitigating student eventual impacts from potential generics.

Speaker 4: Yeah, thanks for the question. I'll go ahead and start off an Ask Chris Chung, who is in China right now to follow up with supplemental comments.

Yes. Thanks for the question I'll go ahead and start off and ask Chris Chung, who is in China right now to follow up with supplemental comments.

Speaker 4: You know, there are a number of things in play that make it really difficult to pinpoint. You know, when we would expect meaningful impact of generic entry, this is a much different dynamic than in the US market. You know, where you have patent expiration, you have a generic launch.

There are a number of things in play that make it really difficult to pinpoint when we would expect meaningful impact of generic entry. This is a much different dynamic than in the U S market.

Where you have patent exploration you have a generic launch.

Speaker 4: And you see immediate erosion of the branch here. And in fact, it's typical, you know, over the course of the first 12 months of generic penetration in a market like the United States. You see 90 to 95% of the value eroded. It's different than that in China for a number of different reasons as we try to outline in the call. But the first reason is because of the fact

And you see immediate erosion of the brand share and in fact, it's typical over the course of the first 12 months of generic penetration in a market like the United States, you see 90% to 95% of the value eroded it's.

It's different than that in China for a number of different reasons as we tried to outline in the call, but the first reason is because of the fact that.

Speaker 4: that it it each of the generics by the time they are able to gain approval are going to have to go hospital by how hospital in order to establish the listing and we really don't anticipate

Each of the generics by the time they are able to gain approval are going to have to go to hospital by hospital in order to establish the listing and we really don't anticipate until we see multiple generics being available and then the advent of the potential for volume based procurement or volume based purchasing before you would see.

Speaker 4: until we see multiple generics being available and then the advent of the potential for volume-based procurement or volume-based purchasing before you would see a meaningful impact on the brands, both price as well as market share. And so while we do expect at some point in time,

See a meaningful impact on the on the brands both price as well as market share and so while we do expect at some point in time there to be the.

Speaker 4: there to be the potential for volume based purchasing. We just can't state when that will be. It's going to be dependent upon.

Potential for volume based purchasing we just can't state when that will be it's going to be dependent upon that.

Speaker 4: the review of the generic applications is gonna be dependent upon the approval of those generic drug products.

The review of the generic applications, it's going to be dependent upon the approval of those generic drug products and thats going to be dependent upon the government and calling for volume based purchasing.

Speaker 4: And it's going to be dependent upon the government in calling for volume-based purchase.

Speaker 4: And so there are a lot of unknowns that make it difficult at this point in time for us to then kind of forecast much beyond 2024. Regardless of what happens, even in the advent of multiple generics being available, we do see in China with other multi nationals, a very strong continued value or revenue stream for the, for the originator that continues on in perpetuity on for several years. In fact, there's, you know, a large multinational.

So there are a lot of unknowns that make it difficult at this point in time for US to then kind of forecast much beyond 2020 for regardless of what happens even in the advent of multiple generics being available and we do see in China with other multinationals are very strong continued value of revenue stream for the for the originator that continue.

News on in perpetuity on for several years in fact, there is no large multinational.

Speaker 4: that has about 15 products that

That has about.

About 15 products that are a part of volume based purchasing and with those 15 products combined they are they are realizing well over $1 billion $5 in revenue. So we still believe that there are great prospects for <unk> in China and in addition to that we have the CIA indication, which we expect a decision on.

Speaker 4: are a part of volume-based purchasing and with those 15 products.

Speaker 4: combined they are they are realizing well over a billion and a half dollars in revenue. So we still believe that there are great prospects for rocks to do stand in China. And in addition to that we have the CIA indication which we expected decision on in the middle part of the year which gives us an additional opportunity for both volume as well as revenue catalyst.

In the middle part of the year, which gives us an additional opportunity for both.

Volume as well as revenue.

Catalysts.

Speaker 4: Chris, let me ask you to go ahead and add some comments to that.

Chris Let me, let me ask you to go ahead and add some comments to that.

Yes, I'm not sure as much to add beyond what.

Speaker 8: Yeah, you know what? I'm not sure as much to add beyond what theme just provided. I thought it was a comprehensive overview and I would add that what Fane just described is not specific to rough to do that. It is very consistent with how the industry is responding to regulations and how the industry is performing.

Amit just to provide a comprehensive overview and I would add that.

Can you just described is not specific to exit these that is very consistent with the industry.

Responding to regulations and how the industry is performing.

Dave back to you.

Yes.

Okay.

Thank you.

As a reminder to ask a question. Please press star one on your telephone.

Speaker 2: As a reminder to ask a question, please press star 11 on your telephone.

Speaker 2: And our next question comes from the line of Andy Shea with William Blair.

And our next question comes from the line of Andy Shane with William Blair.

Yeah.

Speaker 9: Thanks for taking our questions. So mostly on FC3246. Maybe from a strategic perspective, how would you position that after?

Thanks for taking our questions.

Mostly on $32 46.

Maybe from a strategic perspective, how would you position that asset so.

Speaker 9: Would that be in the pre-key move setting, like what we've seen with the base 2 PSMA 4?

Would that be in the pre chemo setting like what we see.

<unk> PSM four and along the same lines given the popularity of the PMA pet imaging agent should that be perceived as a headwind for CD 47 as well.

Speaker 9: And along the same lines, given the popularity of the PSMA that image engagement, should that be perceived as a headwind for a CD-47 as well?

Speaker 9: And maybe also related to that, but maybe from a clinical trial and data perspective. So for the Q1 data readout, it's listed here.

Maybe also related to that but maybe from a.

Kind of a clinical trial and data perspective still for the Q1 data readout.

It is listed here.

Speaker 9: 53 patients total. So it seems like you have presented data on 21 before. So that means we should expect additional 32 patients in the Q1 update. So any sort of clarification is on that. We much appreciated. Thank you. Thanks.

53 patients in total.

So it seems like you had presented data on 'twenty one before so does.

Is that mean you.

We should expect additional 32 patients in Q1 up eight so any sort of clarifications on that would be much appreciated.

Thanks, Andy I'm going to turn this one over to John.

Speaker 5: Yeah, and thanks for the questions. I'll take them in order. In terms of the positioning, we are looking to go into a pre-Kemo setting, although obviously the recent success of Pluvico is sort of...

Yes, Andy Thanks for the questions I'll take them in order in terms of the positioning we are looking to go into a pre chemo setting. Although obviously the recent success of <unk> is sort of.

Speaker 5: you know, has to be factored in when we when we start to really plan out where we're going to target the phase three, but that is still our plan. With regards to the pet imaging, if I understood the question correctly.

Yeah.

<unk> has to be factored in when we when we start to really plan out where we're going to target to phase III, but.

That is still our plan with regards to the pet imaging if I understood the question correctly.

The.

Speaker 5: If the question was, does the broader use of PSMA imaging agents increase the likelihood and maybe comfort of investigators using our pet imaging agent for CD-46? I would say the answer is yes.

If the question was does the does the broader use of PSM a pet.

Imaging agents increase the likelihood and maybe comfort of investigators using our pet imaging agent for CD 46, I would say the answer is yes.

Speaker 5: In a metastatic casteration, resistant prostate cancer, it's become very common for physicians to now do that imaging, you know, for pleuvico and other competitive um...

Metastatic castration resistant prostate cancer, it's become very common for physicians to now do that imaging for Victoza and other competitive.

Speaker 5: PSMA radio nucleolibled antibodies. And then finally, with regard to the additional number of patients.

<unk>.

Radionuclide labeled antibodies.

Then finally with regards to the additional number of patients.

Speaker 5: So the interim data last year at ASCO had 21 patients who were resistive valuable. I think that they had maybe like mid 30 number of patients in that. So there are additional patients who have entered into the trial since that read out. And also some of the patients who were on drug then continue to receive treatment, which I think will have an impact on the measured progression presur Mail.

The interim data last year at <unk> had 21 patients who were resistor valuable I think that they had.

Maybe like mid 30 number of patients in that so there are additional patients who have entered into the trial since that readout.

Also some of the patients who were on drug then.

Continued to receive treatment, which I think will have an impact on the measured progression free survival.

Speaker 4: Thanks, John . And we're gonna follow the data. And ultimately, these men undergo several lines of treatments because none of these treatments that are available today are probably even into the near future are a curative. And so, the Phase II trial will be really, really important to inform them the Phase III design.

Thanks, John and Sandy.

We're going to follow the data.

And ultimately these men undergo several lines of treatments.

Because none of these treatments that are available today or probably even into the near future or curative.

And so the phase II trial will be really really important to informed in the phase III design.

Speaker 9: Got it. Okay. Maybe one last one about the generic proximity stat. So I guess the U.S. is not really an approach for an originator to drop the price and you know, start the price competition. Is that not the case for China? Is there a case where you can kind of drop the price and really compete with with generic entrance?

Got it Okay, maybe one last one about the generic strategy stat.

So I guess in the U S is not really.

For sure as an originator to drop that price.

Price competition is that not the case for China is there a case, where you can kind of drop the price and really compete with.

With generic entrant.

Yes.

It's really.

Speaker 4: Yeah, Chris, let me start it and then you can follow up. It's really dependent.

Yes, Chris Let me, let me start and then you can you can follow up that's really dependent.

Speaker 4: Andy on really the product that you're talking about. As you know in the US, it's very, very rare for the originator to drop the price just because there's no way you could ever make up the value and volume.

Andy on on really the product that youre talking about.

As you know in the U S. It's very very rare for the for the originator to drop the price just because theres no way you could ever make up the value and volume.

Speaker 4: I think because of the way that the volume-based procurement of purchasing works in China, I think that there is likely an opportunity to decrease the price to some extent, but nowhere near what you would see a generic price point to be. Again, just because it doesn't make sense to do that, you'd maintain...

I think.

The way that the volume base.

Procurement purchasing works in China.

I think that there is likely an opportunity to decrease the price to some extent, but nowhere near what you would see a generic price point to be again, just because it doesn't make sense to do that you would maintain volume at a higher price and be far better off than maintaining more volume at a much lower price. So Chris maybe if you want to speak to.

Speaker 4: Volume at a higher price and be far better off than maintaining more volume at a much lower price. So Chris, maybe if you want to speak to Rox, do you think that Rox, do you stand in particular?

<unk>.

Youre thinking about <unk> in particular.

Speaker 8: Yeah, absolutely. So, think of the question. So, looking at how multinational and the bigger brands have historically responded to generic competition. First, when there's generic competition, the decision to lower the price is solely the election of the originator drug. And on the market, we've seen ranges from zero to 15%.

Yes, absolutely.

Thank you for the question. So I'm looking at how multinational example think of brands have historically.

Responded.

Eric competition first windows generic competition.

Tomorrow with a pricing solely the election originated.

And on the market, we've seen ranges from zero to 15 Krishna.

Speaker 9: Once there are enough number of generic drugs on the market and the government calls volume base purchasing, the originated drug can elect to still participate in the market at a particular preset discount that is required by the government. So historically the two bands are either 10% or 30% and for the bigger brands is typically 30%. And this is dictated by the government. Got it. That's super helpful. Thanks so much.

Once there are enough number of generic drugs on the market.

<unk> volume based purchasing.

We continue to drive.

Yes.

So participants in the market.

A particular preset.

Required by the government.

Likely the two bands or even pumped per cent.

Yes, I can.

Thank you for your answers typically 30%.

And this is to take a battleground.

Got it that's super helpful. Thank you so much.

Thank you.

Please for our next question.

Speaker 2: And our next question comes from the line of Jason Gerberi with Bank of America.

And our next question comes from the line of Jason <unk> with Bank of America.

Speaker 10: Hi, good afternoon. This is Dana on Fergie. We've had a couple questions on FG 3246.

Hi, good afternoon.

On for Jason.

We just had a couple of questions on FTE 30 to 46.

Speaker 10: This is based on the activity that you're seeing in the MCR of PC patients in the Phase I trial. The FAR, are you planning to assess 32, 46, and earlier aligned? And I know you're planning to enrich for patients.

This is based on the activity that you're seeing and the CRE <unk> and the phase one trial thus.

Thus far are you planning to assess.

30 to 46 in earlier lines.

And I know you're planning to enrich for patients.

Speaker 10: that expressed on CD46. Could you please remind us what percentage of the patient population you expect?

Express CD 46 could you.

Please remind us what percentage of the patient population you expect to be in that subgroup.

Speaker 10: to be in this subgroup of CD46 expressors. Thank you so much.

CD 46 expresses thank you so much.

John.

Speaker 5: Yeah, thanks for the question. Um, just with regards to going into earlier lines there, the endalutamide combo study that's being run is an investigator sponsored trial at UCSF.

Thanks for the question.

Just with regards to going into earlier lines there the <unk> combo study.

Being run as an investigator sponsored trial at UCSF.

Speaker 5: does open the possibility of going into a first-line setting if that is positive. So, you know, we are following that carefully to see what those results look like, and then we would make a decision, I think, based on those results. Just with regards to the percentage of patients who we expect to be positive,

Does open the possibility of going into a first line setting if that is positive.

So we are following that carefully to see what those results look like and then we would make a decision I think based on those results.

Just with regards to the percentage of patients, who we expect to be positive.

Speaker 5: We have a pretty limited data set at this point regarding, you know, expression by IHC for patients that either do or do not express.

We have a pretty limited data set at this point regarding.

The expression by IHG for patients that either do or do not express <unk>.

Speaker 5: We do think that the pet biomarker will give us much better data on that and really kind of guide our thinking. But based on the data that we have in hand right now, we've been estimating between 50 and 70% of the patients with metastatic cation resistant prostate cancer will be CD46 positive. But I do want to stress that we are looking to acquire more data points to sort of firm that number up.

<unk> 46.

We do think that the pet biomarker will give us much better data on that and really kind of guide our thinking that based on the data that we have in hand, right now we've been estimating between 50 and 70% of the patients with metastatic castration resistant resistant prostate cancer will be <unk> 46.

Positive, but I do want to stress that we are looking to acquire more data points to sort of firm that number up.

Speaker 4: And we won't be enriching in the phase 2 trial. We're going to be assessing the patients ahead of treatment with RCD3246 or RCD46. And then once the efficacy results are in, then we'll do a correlation with the PET positivity and in the efficacy results.

And we won't be enriching in the phase II trial we're.

We're going to be.

Assessing the patients.

Treatment with <unk>.

Our CD $32 46, or <unk> 46.

And then once the efficacy results are in and then we will do a correlation with the.

Pet positivity.

Positivity and and the efficacy results.

Speaker 10: Got it. Thank you. And just a quick follow up. Just thinking more broadly kind of your strategy for this, you know, for this potential acquisition during these next four year period, you know, you have.

Got it. Thank you and then just a quick follow up.

Thinking more broadly kind of your strategy for that.

Forward at potential acquisition. During these next four year period.

You have them.

Obviously.

Speaker 10: you know, obviously success in this MCRPC trial will be important, but you know, do you have any plans to assess this indication or this, sorry, acid and other indications?

And see RPC trial will be important right.

Do you do you have any plans.

Indications are that sorry asset in other indications in the next four years.

Yes, we do in fact, we've got a we've got the <unk>.

Speaker 4: Yeah, we do. In fact, we've got a, we've got the plans to do a, a tumor expansion trial as well.

<unk> to do it.

Tumor expansion trial as well.

Speaker 4: And it's just a matter of determining exactly when the right time is to do that tumor expansion trial, whether we, you know, go ahead and pull the trigger on it earlier or wait until we see some sort of an efficacy signal in the phase two trial. We'll just, we'll make that call at some point in the future. But yeah, there's, there are definitely plans. And you heard John speak about multiple myeloma in his remarks as well.

And it's just a matter of determining exactly when the right time is to do that tumor expansion trial, whether we.

Go ahead and pull the trigger on it earlier or wait until we see some sort of an efficacy signal in the phase II trial, we'll just we'll make that call.

At some point in the future, but yes, there are definitely plans and you heard John speak about multiple myeloma and <unk>.

His remarks as well.

Thank you so much.

Speaker 2: Thank you. I'll now hand the call back over to CEO , Thane Wedding for any closing remarks.

Thank you.

Now I'll hand, the call back over to CEO <unk> <unk> for any closing remarks.

Speaker 4: Well, thanks everybody. We appreciate your participation in today's investor call and your interest in Fibergian. Enjoy the rest of your day. Thank you.

Well. Thanks, everybody. We appreciate your participation in today's investor call and your interest in fiber Jen and enjoy the rest of your day. Thank you.

Okay.

Speaker 2: Ladies and gentlemen, thank you for participating. This concludes today's program, and you may now disconnect.

Ladies and gentlemen, thank you for participating this concludes today's program and you may now disconnect.

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Speaker 11: St.