Q2 2023 FibroGen Inc Earnings Call

August 7, 2023

[music].

Okay.

Good afternoon, everyone.

Oh.

Good day, and thank you for standing by and welcome to the fiber again second quarter 2023 earnings call. At this time all participants are in listen only mode. After the speaker's presentation there'll 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 your hand is raised to withdraw your question. Please press star one one again please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, David de Lucia. Please go ahead.

Good afternoon, everyone. Thank you for joining today to discuss our second quarter 2023 financial and business results I'm, David de La <unk>, Vice President of corporate SG&A and Investor Relations at fiber John joining.

Joining me on today's call are saying work, our interim Chief Executive Officer, Juan Graham, Our Chief Financial Officer.

Doctor Marc Eisner, our Chief Medical Officer, Dr. John Hunter, Our Chief Scientific Officer, Chris Chung, Our senior Vice President of China operations, and Enrique Conterno, our outgoing Chief Executive Officer.

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 forward looking statements about fibre channel.

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.

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.

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

<unk> 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 <unk>.

Virgin Dot com.

That I would like to turn the call over to Enrique Conterno.

Thank you, Dave and good afternoon, everyone.

First I would like to take a moment to.

To thank my <unk> colleagues.

Thank you for your commitment and dedication during my tenure as CEO .

It is important for me to highlight that despite the setback we have recently faced.

I remain enthusiastic about <unk> opportunities.

Given our.

Our remaining near term readouts.

From a revenue of trials with Duchenne muscular dystrophy and pancreatic cancer.

A thriving rux and <unk> business in China.

And our exciting early stage pipeline.

Furthermore.

We have a strong cash position.

That allows us to see through the evolution of our pipeline as.

As well as our talented team across the board.

I am proud of the quality of our leadership team.

I'm delighted.

The pain will be leading fiber Jen.

As interim CEO .

I have known <unk> for over 25 years.

And have worked closely with him at five region during.

During his three years of Chief commercial officer.

And at Lilly for about 10 years in his capacity as Chief marketing officer for Lilly diabetes.

Where he launched several blockbuster medicines.

During that period of odd percent that growth of lilly's diabetes business.

During our time working together.

I have appreciated his excellent judgment.

<unk> business ink sinks.

<unk> ability.

To lead organizations effectively.

So.

Without further delay I would like to pass the call to Mr. <unk>.

Thank you Enrique for all that you have done for fiber churn over the past three years.

We have built an outstanding leadership team created a performance oriented culture and built our early stage pipeline personally I've had the benefit of working with you for the better part of the past 14 years at Lilly and hear our fiber Jen and I will do my best to lead fibers and toward a bright future I'm personally excited about the opportunities we have in front of us to bring value to patients.

And create value for shareholders, many of which we will highlight in this call.

Good afternoon, everyone and welcome to our second quarter 2023 earnings call on today's call I will focus on 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, providing a perspective that we have not yet discussed in this type of forum.

Lastly, one gram our CFO will review the financials after which we will open the call for your questions.

Starting on slide three.

The region has four key strategic pillars that we believe offer significant value today.

First as Pam Revpar map with three upcoming late stage Readouts, starting this quarter and through the first half of next year.

Each indication, which I will walk through in more detail in the coming slides represents a significant commercial opportunity in diseases of substantial unmet need.

Second is <unk> <unk>.

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

Third is our early stage oncology pipeline. We recently completed the in license of $4 46, now known as FG $32 46, a first in class potent antibody drug conjugate or ADC for the treatment of metastatic castration resistant prostate cancer.

This license also includes a biomarker driven opportunity through the development of an associated biomarker diagnostic.

In addition to FG $32 46, we are also undertaking IND, enabling activities on two innovative oncology molecules with the intention of commencing clinical activities in 2024.

Fourth is our strong cash position costars efforts one results we have implemented a companywide cost reduction plan that extends our cash runway into 2026, which provides the company a bridge to achieved numerous value inflection points across our portfolio.

We have taken the necessary steps to improve our strong financial position and we'll continue to focus on financial discipline and.

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 fiber Jen. We believe that we have a strong foundation to drive significant shareholder value.

Creation.

Day and into the future.

Moving to slide five <unk> is an anti CTG human monoclonal antibody in clinical development for the treatment of ambulatory Duchenne muscular dystrophy more DMD.

Locally advanced Unresectable, pancreatic cancer, or <unk> and metastatic pancreatic cancer.

<unk> has been studied in over 1000 patients and has demonstrated a favorable adverse event and safety profile, including in patients who have been dosed for up to seven years.

On slide six I would like to provide a recap our recently announced <unk> results as well as review our upcoming milestones.

In June we reported topline data from our phase III <unk>, one study a placebo controlled trial of <unk> for the treatment of non ambulatory patients with DMD background corticosteroids.

The study did not meet the primary endpoint of performance of the upper limb to point out.

Score at week 52 compared to baseline.

<unk> would like to thank the patients caregivers and clinical trial investigators for their dedication to participating in these important studies, which contribute towards the understanding of this devastating disease.

In June we announced top line data from <unk>, one study in IPF.

The study compared treatment with <unk> to placebo and did not meet the primary endpoint of change from baseline in forced vital capacity or <unk> at week 48, with a P value of 0.29 <unk>.

The mean decline in FEC from baseline to week 48 was 260 ml in the <unk> arm compared to 330 ml and the placebo arm correlating to a placebo corrected difference of 70 ml.

The secondary endpoint of time to disease progression, which is a composite of FPC percent predicted decline of greater than or equal to 10% or deaths was also not met with a hazard ratio of zero point 708.

Based upon these results we just continuous efforts to our second phase III clinical trial, we would like to thank the patients and clinical trial investigators for their dedication and participation in both of these IPF trials.

Looking ahead, we anticipate upcoming results from three <unk> trials, we expect top line data from Atlanta to an ambulatory DMD later this quarter.

We expect results from LAPIS and La <unk> in the first quarter of 2024 and.

And we expect results from the pancreatic cancer action networks precision promise adaptive trial platform evaluating <unk> in both first line and second line settings in combination with standard of care for patients with metastatic pancreatic cancer in the first half of 2024.

I will now go into each of these opportunities in more detail starting with Duchenne muscular dystrophy.

DMD is a rare and debilitating neuromuscular disease that affects approximately one in every 5000 newborn boys.

About 20000 children are diagnosed with DMD globally each year.

The payroll disease is caused by a genetic mutation leading to the absence or defect of dystrophin.

Routine necessary for normal muscle function.

The absence of dystrophin results in muscle weakness muscle loss fibrosis and inflammation pain.

Patients with DMD are often wheelchair bound before the age of 12 and their progressive muscle weakness may lead to serious medical problems related to respiratory and cardiac muscle.

On slide eight.

We note that will lantus to enrolled 73 ambulatory DMD patients six to 12 years of age.

The primary endpoint is the Northstar ambulatory assessment are.

A measure of ambulatory function and we expect top line results later this quarter.

Given the devastating nature of DMD and the relentless progression of the disease. We are hopeful that we will enter two phase III study can lead to a regulatory filing and ultimately provide a desperate need desperately needed therapy for these patients.

On slide nine we provide a perspective of the commercial opportunity for <unk> in DMD.

In 2022 branded revenue of DMD therapies exceeded $1 1 billion. Despite the fact that the currently approved exon skipping therapies target only a small proportion of DMD patients and have yet to demonstrate a meaningful clinical improvement in symptoms or disease progression.

There is a clear need for DMD therapies that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function.

We are hopeful that the anti fibrotic mechanism of Perm rebel Nab, maybe a treatment that can help these patients and their families and represents a significant commercial opportunity for <unk>.

Moving on to pancreatic cancer on slide 11.

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 in an overall five year disease free survival rate of approximately 12%.

On slide 12, we would like to provide a brief overview as to why we believe an anti <unk> antibody like <unk> would provide benefits to patients diagnosed with pancreatic cancer.

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

Mouse 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 the use in both <unk> and metastatic pancreatic cancer.

Moving to slide 13.

Late stage trials are being conducted with <unk> and both <unk> and metastatic patients.

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

Given <unk> potential opportunity to treat a vast majority of patients across this devastating disease.

On slide 14, we provide an overview of the 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 top line data from this study in the first quarter of 2024.

On slide 15 is an overview of the pancreatic cancer action networks precision promise trial. This is a phase two three registration study with an FDA approved study design.

The primary endpoint is overall survival, which represents a definitive registration endpoint.

The <unk> combination therapy is offered to patients as either a first or second line treatment option.

<unk> was the first experimental treatment arm to be offered as a first line treatment in pan cancer innovative precision promise trial.

We expect topline data from this study in the first half of 2024.

On Slide 16, we review the commercial opportunity for <unk> in pancreatic cancer.

There have been limited treatment advances over the last two decades, and both unresectable and metastatic disease with immuno oncology therapies, providing benefit to a small subset of metastatic patients.

This creates a potential multibillion dollar commercial opportunity for <unk>, if it can demonstrate a significant improvement in overall survival and either locally advanced or metastatic patients.

Moving on to <unk> on slide 18.

I would like to provide a recap of recently announced Roxanne just that results as well as review our upcoming milestones.

In May we announced topline data from our Matterhorn phase III clinical study of <unk> for treatment of anemia in patients with transfusion dependent lower risk Myelodysplastic syndromes.

The study did not meet its primary efficacy endpoint.

Also 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.

I am pleased to announce that we have filed a supplemental new drug application with the China Health authority for <unk> in patients with chemotherapy induced anemia and expect approval in mid 2024.

We believe this indication could represent a meaningful incremental net revenue opportunity.

<unk> just to add a potential pathway to achieving over $500 million in annual net sales in China.

Moving now to slide 19, <unk> for anemia of chronic kidney disease continues to perform extremely well in China.

Second quarter total <unk> net sales in China by fiber Gen and the distribution entity jointly owned by <unk> and Astrazeneca was $76 4 million compared to $53 1 million in the second quarter of 2022, an increase of 44%.

This growth was driven by an increase in volume of over 40%.

Barbara <unk> portion of <unk> net product revenue in China was $23 9 million for the second quarter on a U S GAAP basis.

Moving to slide 20, <unk> just it remains the category leader in brand share in China rising to 39% in the second quarter of 2023.

I would like to briefly touch on <unk> in Europe .

In addition to the continued outstanding performance of <unk> in China. The rocks just didn't launch in Europe is accelerating showing robust quarter over quarter growth we.

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

Roxanne just yet is the only <unk> indicated in the EU for the treatment of anemia of <unk> in both non dialysis and dialysis patients and.

And with Gsk's recent decision to withdraw the MAA for that produced at <unk>.

Combined with market exclusivity for <unk> beyond 2030, <unk> as you said is well positioned to continue its growth throughout this decade.

Moving to slide 22, and our early stage oncology pipeline.

On May eight we announced that <unk> <unk> into an exclusive license with cordis therapeutics for FG $32 46.

Potential first in class opportunity that our CSO, John Hunter will describe in more detail on the next few slides.

Under the terms of the agreement there was no upfront cash consideration.

Fiber general conduct and fund future research development and manufacturing of FG, 32, 46, and an associated biomarker pet 46.

We have the option to acquire Fortis during the four year evaluation period for $80 million.

We anticipate the initiation of a phase II trial in metastatic castration resistant prostate cancer or <unk> in the second half of 2024 with the potential for additional trials targeting other CD 46 expressing cancers.

I will now hand, the call off to John to cover our early stage pipeline.

Thank you.

Moving to slide 23, our recently in licensed clinical program at June $32 46 is an antibody drug conjugate or ADC comprised of an anti CD 46 antibody y S. Five linked to the anti mitotic agent MSA, which is a clinically and commercially validated ADC.

Sure.

The CD 46, epitope targeted by <unk> $32 46 is expressed at high levels in the majority of metastatic castrate resistant prostate cancers and colorectal tumors and is also found at high levels in a subset of other solid tumors.

Moving to slide 24.

<unk> $32 46, and demonstrated monotherapy clinical efficacy in multiple myeloma in metastatic castration resistant prostate cancer.

Shown here are interim data from the ongoing phase one trial in prostate cancer, where four out of 21 Evaluable patients had a partial response based on resist criteria.

We're at PSA 50 response rate of 45% was observed.

Patients in this phase one study were heavily pretreated with a median of five prior therapies.

The safety profile for <unk> $32 46, with consistent with other <unk> based ADC therapeutics with neutropenia being the most common adverse event additional data from the trial will be reported upon completion.

Moving to slide 25, we show ongoing and planned clinical trials for <unk> $32 46 and.

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

Treatment, therefore, potentially making them more responsive to treatment with FG $32 46 initial.

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

There is currently a biomarker study trial and progress for the program also being run at UCSF.

Imaging agent is comprised of the CD 46 targeting antibody.

Five coupled to zirconium 89.

Goal is to develop the screening assay to select patients with ICD 46 expression, who are most likely to benefit from treatment with FG $32 46.

Biomarker will be part of the phase III study run by fibrinogen, and which up to 100 patients will be enrolled following a pet scan at 46 patient.

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

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

Moving to slide 26, I would like to spend some time on our preclinical oncology program.

The first program I'd like to discuss is <unk> $31 65, an anti <unk> antibody developed to reverse immune assistance in solid tumors.

<unk> nine per gallon.

As 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 FG.

<unk> 31, 65 has been shown pre clinically to reverse multiple gel nine mediated mechanisms of immune suppression, including the prevention of <unk> effector T cell <unk> and Tim three dimerization, we will present preclinical data for this program in the cancer Immunotherapy conference.

Later this year and are working towards the first quarter 2024 filings.

Moving to slide 27, and our CCI program.

<unk> is a receptor that is highly expressed on tumor infiltrating T regulatory cells known as T. Reg.

<unk> limited expression outside of the tumor microenvironment.

<unk> 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.

Given the highly competitive clinical landscape for antibodies targeting <unk>.

Developed optimized versions of our previous FG $3 63 during its development.

<unk> thousand 163 has been shown to have acceptable potency and monotherapy efficacy in a preclinical model of colorectal cancer, we decided to advance FG 31, 75 is our clinical candidate as we feel it is a market competitiveness competitive advantage based on relative potency and projected.

Clinical dosing.

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 will now turn the call over to Juan to discuss the company's financials.

Thank you John .

Good afternoon, everyone I will jump straight into the quarter's financial results for.

For the second quarter of 2023 total revenue was $44 3 million compared to $29 8 million for the same period in 2022.

A robust increase of 49% year over year I will now provide further detail on our revenue.

Q2, 2023, we recorded $23 9 million of net product revenue for <unk> sales in China compared to $23 3 million in the second quarter of 2022.

Representing an increase of 3% year over year.

During the quarter, we also recorded $14 $3 million in drug product revenue for <unk> bulk drug product or active pharmaceutical ingredient sold to astellas.

<unk> drug product revenue was $1 1 million during the second quarter of 2022.

We recorded development revenue of $4 $1 million associated with co development efforts for <unk>.

With our partners as compared to $5 $2 million during the second quarter of 2022.

As I have previously stated due to the stage of development of <unk> with our partners. We expect co development revenue to be in the range of $3 million to $5 million per quarter for the remainder of 2023.

Finally, we recorded license revenue of $1 million associated with the milestone payment from our biosynthetic cornea program with Illumina X.

Given the strong performance of our business in China, I will provide further context on our financial performance.

As previously mentioned by <unk> total <unk> net sales from the joint distribution entity jointly owned by Astrazeneca and fiber, Jim or J D. E was $76 4 million this quarter compared to $53 1 million in the second quarter of 2022.

A substantial increase of 44% year over year, highlighting the continued strong performance of the <unk> franchise in China, achieving our highest market share since launch at 39% of the ESR and hip categories combined.

From total <unk> net sales in China fiber dense net transfer price from sales to the JV was $23 8 million for the second quarter compared to $18 2 million in the second quarter of 2022 and.

An increase of 31% year over year net transfers met transfer price is the best reflection of fiber <unk> portion of the cash received by <unk> and China.

During this quarter, we deferred $3 3 million in revenue due to the change in our future estimates as per U S. GAAP, primarily driven by unfavorable and favorable.

Favorable reminbi currency impact amongst other estimates as.

As we have communicated in the past the deferred revenue balance and fiber Gen. China fluctuates based on management estimates of future revenue.

As a result fiber agenda recorded $25 million in net revenue for the quarter from <unk> sales through the J D E and $3 $4 million of direct to distributor sales from fibers in China totaling $23 9 million on a U S GAAP basis.

Now moving down the income statement, our operating costs and expenses for the second quarter of 2023 were $132 4 million compared to $108 million for the second quarter of 2022.

The variance of $24 $3 million year over year is primarily driven by a onetime charge of acquired in process R&D of $24 $6 million, resulting from the recent noncash asset acquisition of Fortis therapeutics as per U S. GAAP, excluding such one time noncash charge.

Our operating expenses would be essentially flat year over year.

R&D expenses for the second quarter of 2023 were $95 5 million compared to $71 million in the second quarter of 2022.

As I just mentioned R&D expenses for the second for the quarter include a one time charge of acquired improves as R&D expenses of 20, $24 6 million, resulting from the recent noncash asset acquisitions.

<unk> therapeutics, excluding such onetime charge R&D expenses were $79 million for the quarter again, essentially flat year over year.

Of the $79 million of R&D expenses that I, just mentioned approximately 59% was dedicated to <unk> map development and CMC activities.

89% allocated to support our early stage pipeline and the remaining 12% directed towards <unk> development.

Activities in the United States and China.

Given the outcome of the IPF trial.

First one with subsequent impact on the termination of separate two we will see a significant reduction in R&D expenses related to primarily the map in the coming quarters.

SG&A expenses for the second quarter of 2023 were $31 2 million compared to $33 million in the second quarter of 2022.

The remaining relatively flat year over year.

During the second quarter of 2023, we recorded a net loss of $87 7 million or 19 net loss per both basic and diluted share as compared to a net loss of $72 6 million or <unk> 78 per basic and diluted share for the second quarter of 2022.

The impact of the above mentioned, one time charge of $24 $6 million related to the noncash asset acquisition afford this represents approximately 25.

Net loss per basic and diluted share.

On July 14, 2023, as part of a broader cost reduction effort, we announced a restructuring plan to lower our operating expenses.

The plan includes an expected reduction to fiber <unk> U S workforce of approximately 32% or 104 employees.

We estimate that the <unk>.

Related nonrecurring restructuring payments to be in the range of $13 million to $15 million.

The majority of which will be incurred in the third quarter of 2023.

In addition to head count related reduction we are also expecting reductions in other expenses associated with our recently announced termination of our IPF trials and general reduction in infrastructure costs.

On slide 29.

Les out our expected future GAAP savings associated with the reductions I just mentioned.

In the first half of 2023, our average GAAP operating expenses and one time charges were approximately $105 million per quarter.

Excluding onetime expenses and charges, we anticipate expected savings of approximately $100 million to $120 million in total annualized GAAP expenses.

Or $25 million to $30 million per quarter.

We expect to achieve up to 20% of these quarterly savings in the third quarter of 2023, 60% to 80% of expected quarterly savings in the fourth quarter of 2023.

And achieve our quarterly expected run rate savings in the first quarter of 2024.

Now shifting towards cash as of June 30, we reported $361 $3 million in cash cash equivalents investments and accounts receivable.

Our cash balance includes $71 3 million of net proceeds raised through our debt facility with Morgan Stanley tactical value and additional use of our ATM facility during the quarter.

With the reduction of operating expenses and maintaining a disciplined capital allocation approach, we expect our cash cash equivalents investments and accounts receivable to be sufficient to fund our operating plans into 2026.

And now I would like to turn the call back over to me.

Okay.

Thanks, Juan in closing we are committed to advancing <unk> as a potential first in class medicine in three indications with significant unmet medical need and as noted we expect topline data from the following three late stage studies.

Phase III Atlantis to an ambulatory DMD this quarter.

Ms III LAPIS and la <unk> in the first quarter of 2024.

Phase two three pancreatic cancer action network or Pan can precision promise trial in metastatic pancreatic cancer in the first half of 2024.

<unk> continues to perform very well in China, where we recently filed our NDA for the CIA indication and our partner Astellas continues with the commercialization of <unk> in Europe and Japan.

And our early stage pipeline, we anticipate filing an IND for.

<unk> thousand 165, the anti <unk> antibody in the first quarter of 2024.

Filing an IND for FG 31, 75, our anti <unk> antibody in the second half of 2024, and the initiation of a phase II trial of FG $32 46 for metastatic castration resistant prostate cancer in the second half of 2024.

We have completed incremental financing transactions to further strengthen our balance sheet and expect our current cash position.

Fund operations into 2026.

I would like to thank all of the employees of <unk> for their continued hard work and perseverance over the last few months I would now like to turn the call back over to the operator for Q&A.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again, please standby while we compile the Q&A.

<unk>.

Our first question comes from the line of Michael Yee with Jefferies. Please proceed with your question.

Hi, This is Josh on the line for Michael Thanks for taking my question I think kind of two questions. If I may.

First for Rux I'll, just add could you help us understand the patent.

<unk> situations for Russia, and China and.

What is your base case for the timing of a potential generic.

Generic entry and what other ways to extend the exclusivity and then for 446.

Why are you excited about this ADC program and.

And I also notice you have a phase one well that was a phase one multiple myeloma. So are you at all.

Pursuing the opportunity in this indication.

Are there any other indications that you are thinking about thank you.

Well. Thank you for your question.

The first part of it related to <unk> China.

Hatton term exclusivity generic entry I would like for Chris Chung to address that question.

Chris.

Thank you thank you Jeremy.

Yes.

Okay. Thank you. So thank you for the question.

Confirm that the health authority and China has affected a number of generic applications <unk> and <unk>.

This will be of course.

Just to clarify on a second let me.

David Hutchens.

Filing.

Technical review is about.

It does not.

Absolutely.

Approval on shape or form.

Our competition matter patent expires mid 2024.

Isn't the patent system in China.

Not expecting any generics of Brexit do you start to be marketed until at least after that.

James.

Now of course, the composition of matter patents represents only one of many patches that we have in our patent portfolio all of which we intend to defend.

Recently in China.

Also a point that I should point out unlike in the U S. There is life.

Thank you Nader brand asset package.

<unk> and <unk>.

Some cases.

But you need a branch actually increases although of course at a lower price.

We remain optimistic about our options obviously activity front.

We are pursuing all intellectual property options and market access tactics to preserve and extend period of time.

As you saw earlier, we saw robust growth in market share in people processes and CTD.

I believe there is tremendous market potential in that space allow for significant growth.

Of course, CIA with representing that the size of the market.

Back to you.

Thank you, Chris and then related to the question about $4 46.

Why were excited.

Like for Jon Hunter to address that question and then if mark has any comments after that.

Add onto that.

John .

Sure. Thanks.

I think one of the biggest points of excitement was really seeing monotherapy efficacy.

Very hard to treat patient population as I had mentioned these patients were heavily pretreated and we saw partial response rate of about 20%.

Very good PSA set the response rate.

So that was quite exciting relative to other.

Assets that we're looking at but also the mechanism and it's very well validated as I had mentioned there are I think now five.

Approved adcs that use and then the payload.

Additionally, when we really did a deep dive in the <unk> 46 expression we saw that.

It was quite restricted to tumors for the most part with only a couple of normal tissue tissue, so im showing any.

Considerable expression so.

We have an entire package that we felt look very good and we're very excited to bring it in.

I'll talk about potential other indications and then I think I'll turn it over to Mark to address the multiple myeloma question.

We are in fact looking at indications to expand into we have an ongoing translational medicine effort to identify.

<unk> antibodies that we may use to be able to run a basket trial in patients from other solid tumor indications, where the prevalence of CD 46 expression might not be as high, but where we can select patients.

Do you have that high expression to enter into the trial.

These are very early efforts, so we will hotels.

As they progress.

Mark I'll hand, it over to you for any additional comments.

Yeah, Thanks, Jon I mean I think.

I'm also very excited about the molecule because or the ADC because it has several potential ways to help patients too.

To really add value to fiber Gen. One is as you said in.

Metastatic castrate resistant prostate cancer in mono therapy. The other one is in Enzo combo therapy, which is a current ongoing study at UCSF as you mentioned the other one is either solid tumors <unk> multiple myeloma, so multiple diseases seem to be driven by CD 46. This is a very novel ADC.

We have a parallel pet imaging biomarker strategy that we're pursuing so I think theres, a novelty and a deep biology underlying this program that's very exciting.

And I think maybe just to conclude related to the excitement for the <unk> asset is the favorable deal terms with no upfront cash consideration success based milestones and the opportunity over a four year period of evaluation to potentially acquire the company for $80 million in it.

<unk>, obviously, what John and Mark just spoke about.

Really excited about the opportunity.

All right. Thank you.

Can I follow up on the first one.

Any way to extend your exclusivity for Rockstar win.

After your CIA indication gets approved.

And.

So how should we be thinking about it so there is eight points.

Intellectual property in China.

With activated.

2021.

At this point in time the regulations is not yet implemented so we are.

Looking at those opportunities with F 18.

That decision would come down to what.

The Chinese company eventually decides.

Okay. Thank you.

Welcome.

One moment for our next question.

Our next question comes from the line of yarn Werber of TD Cohen.

Please proceed with your question.

Hi, This is joey on for your own. Thanks, so much for taking a question.

Maybe just a couple from US first on the CIA can you tell us about your latest thinking around whether this is ultimately going to be a China only strategy.

You are thinking that this is going to come to the U S as well.

And then for the LAPIS study could you just quickly remind us about the potential use of event free survival.

As a surrogate for accelerated approval. Thank you.

Yes, Thanks, Joyce related to CIA as it right now as a China only opportunity and Mark would you like to touch on the <unk>.

Question on that Lucas, Yes. So the question has to do with the primary endpoint of this study which is overall survival.

You'd mentioned in an earlier call. We did do an interim analysis for event free survival as a potential surrogate marker. It was a very high bar analysis it did not.

That analysis. So we're continuing the trial for overall survival as the primary endpoint and we expect that to readout in first half of next year.

Yes.

Great. Thank you.

One moment for our next question.

Our next question comes from the line of Jason <unk> of Bank of America. Please proceed with your question.

Oh, Hey, guys. Thanks for taking my question.

Just coming back to the patent Todd.

Topic in China is the process with the generic challengers entirely an issue of patent validity and if the patent is found valid then.

There is a barrier until the expiry of the crystalline form IP or is there a potential avenue of those generic challengers have defer non infringing crystal informed molecule if they could potentially have an avenue to be found non infringing I just wanted to understand.

That dynamic a little bit better and then on Pam Rev for ambulatory DMD I'm wondering if you could highlight any important mechanistic differences why Pam Rev.

<unk> be more effect here than say the non ambulatory setting thanks.

Thanks, Jason.

If you could take the first question.

Absolutely.

So with respect to generic challenges, so first and foremost our composition of matter patents.

Is valid.

All generic applicants on the patent linkage.

System in China have to crop up we respect those patents.

That is a fact and this is why we're very comfortable with that.

Generic on the market after that.

With respect to the Cooper line Hopkins Cristina <unk> patents are not considered part of how to make the system, which means theyre not enforceable.

The health authority.

Forcible either quite along and that is what we will have to ask.

As to whether a generic applicant could potentially has eight Chris Mike warm and alternative polymorph.

Patents that could get around us that unfortunately, I think the question.

Question relative deferred to the patent attorneys.

Tim.

I hope that's helpful.

So the other question was around ambulatory versus non ambulatory DMD and <unk>.

We've always said that we expected non ambulatory DMD to be the most challenging because the patients have already lost so much function narrowed wheelchair bound in the signal to noise ratio of the endpoint the performance of the upper limb.

We expect it to be a challenge and turned out to be a challenge. We also didn't see any clinically meaningful efficacy in terms of the other secondary endpoints, including FPC percent predicted.

Injection fraction by cardiac MRI, Unfortunately, and it's very sad for all of us at <unk>, because we were really hoping to be able to deliver a therapy for.

These patients with non ambulatory DMD, which is so desperately needed. So now we turn our attention to ambulatory DMD, where because these are younger patients. They already are they still have much more function I think the Northstar ambulatory assessment is a more holistic type of endpoint, we do feel like we still have a possible.

<unk> of showing a benefit in this patient population and we're really looking forward to those top line results in the near future.

Got it thank you.

One moment for our next question.

Okay.

Our next question comes from the line of antibiotics anemia of Stifel. Please proceed with your question.

Hi, Thanks for taking my question just while we're on the DMD topic.

I guess.

One of the things we're wondering is.

And the ambulatory DMD.

Trial, you don't necessarily see function, but you see benefit on some of these other markers such as injection fraction RPC.

Can you see an avenue for filing on that.

And in the non ambulatory.

Understanding that the non ambulatory is more challenging.

With SEC and injection fraction are they is it also more challenging.

On those measures as well.

Or.

Or is it strictly on that on the functional endpoint that you.

We're referring to.

Thank you.

Yes, so I'll try to address both of your questions. So the second part first yes, I think that all endpoints are going to be more challenging in the non ambulatory population in the ambulatory well I will say that the cardiac MRI is not really.

The same relevance for the younger patients who are aged six to 12, because that's a relatively cardiac manifestations are relatively later.

Manifestation in the disease for ambulatory, it's the Northstar.

Stair climb 10 meter walk other other endpoints like that are the primary and secondary endpoints.

So.

Ultimately the North Star I think has been quite well.

<unk> in the setting of <unk>.

Other studies and we expect that.

It's a validated endpoint and we're looking forward to those results.

Okay sorry.

Is there any avenues for you to file as Youre seeing secondary benefits.

The Northstar.

Alright.

Your question is for example, the North Star is kind of a near Miss in their secondary endpoints that are positive. So in that case potentially I mean any positive data that we see in the ambulatory trial I think will be the basis for us to want to really explore.

Regulatory pathways with the FDA, so it'll be a data driven decision, but we of course will look at all of the endpoints and.

Really look for any signs of efficacy in that trial.

Coming out.

Okay, and then if I can ask one more question with regard to September .

<unk> is an anti fibrotic agent are there any other markers that you looked at.

From the Atlanta, one trial.

Given that give you an idea that there is there is actually anti fibrotic activity.

But since the confidence about.

Just going into the trial and so I'm just wondering if you saw anything else that that 80 some odd.

Yes.

Unfortunately, the relentless one trial was really there was no end point that really.

Any signs of efficacy it may be due to the non ambulatory population and how advanced it is.

I think the ambulatory Atlanta's two trial data will really help us to answer what clinical benefit in an otherwise can be shown in DMD. So I think the studies will together or tell the full story. So we have half the answer.

Eagerly awaiting the rest of the information from all interest too.

Okay, great. Thank you.

Thank you for the questions.

One moment for our next question.

Our next question comes from the line of Alexandra Ramsey from William Blair. Please proceed with your question.

Hello. This is Alex Ramsey on for Andy Hsieh, William Blair answer a couple of questions from the if you don't mind. So the first question is about the term loan with Morgan Stanley 's tactical value.

Just curious about the status of the $75 million initial term loan.

Are there any plans to pay back that one earlier than in May 2026, maturation date or it does take to hit by the terms of alone.

And then second Mark on Libre curious to hear if you have any insights on that first data and Michelle any hypothesis in terms of why it underperformed.

And we definitely understand that are probably early in analysis and we're just wondering if anything's popped out sharing initial now inc. For months.

Yes, Thanks, Alex I'll have one address the <unk> question, and then turn it over to Mark.

Hey, Alex Yes on the term loan as you pointed out we have an initial draw of $75 million that ASP has actually occurred.

Jeff.

The beginning of May may eight I believe it was we received a $75 million.

So thats why do we would expect to hold on to until term maturity.

At this point in time, there is no plan for early repayment.

Thanks, a lot mark.

So.

In terms of as our first one study, yes disappointing results in terms of the primary endpoint and the secondary endpoints none of them most of which showed kind of numerically better results for Pam versus placebo, but none of which were statistically significant.

The kind of.

Three major issues going into the trial that I think we and everyone was focused on number one was would the placebo decline at 48 weeks in Zephyrus one.

Be adequate to show a treatment effect and it was it was 330 ml decline, which compare it very similarly.

308 ml. The second point was the influence of prior history of standard of care in about half the patients where treatment experienced about half were treatment naive and that really made.

No real meaningful difference on the results and then the last point that I think was a lot of focus are what about those patients who started the standard of care on that turned out to be about 14% started <unk> on study and again that did not make any meaningful difference in the study results. So the top three.

Things, we were really focused on and I think the.

Analyst and Investor community was focused on really turned out to be within what we would have predicted. So at this time, we don't have any clear reason why this <unk> results were less significant then.

<unk> results, except to say that.

The phase II to phase III translation in this disease IPF is very very challenging if you look at the <unk>.

Galapagos Gilead or you look at the Roche data they've run into similar challenges and I don't think these charges are completely understood at this time.

Alright got it. Thank you so much very helpful.

Thank you for the question.

One moment for our next question.

Our next question comes from the line of Paul Choi with Goldman Sachs. Please proceed with your question.

Hi, Thanks, good afternoon, and thank you for taking our questions.

Maybe returning to the subject to <unk> for a minute.

Two.

Is there any component of the North star.

You think where <unk> might show particular benefit any any gleaning fair in the ambulance.

Ambulatory population would be helpful.

Alright, well the short answer Paul is we really don't know I mean, the total score is designed for the total score.

And we'll be looking at data will also be looking at.

Pardon me 10 meter walk the stair climb other components, but at this point in time, it's difficult to answer that question I think we'll have to await the data.

Yeah.

Okay fair enough.

And then turning to your oncology pipeline in FTE at $32 46, Youll have the combination study with <unk> next year.

Curious if you can maybe sort of frame expectations for what what responses might look like whether it's on PSA or how youre thinking about comping the results versus either monotherapy studies or other <unk>.

Andy Sundays with came out any any framework or context would be appreciated. Thank you.

Yes, Thanks, Paul I'll have John address that second question.

Sure, although I think mark might have better insight into it but just with regards to how we're viewing it.

We kind of have a baseline with the monotherapy results and we know what.

To expect with.

2246 alone so really I think with the extend the combination will be looking to see if there is additional benefit and.

And we'd be looking both at the PSA 50, and overall response rate given that we did see those in the.

Earlier phase one trial.

Mark you might want yes.

Sorry, John I was just because they have exact same perspective, if it does increase $2 46 expression.

<unk> that is that we could expect to see a greater degree of clinical efficacy. That's the hypothesis that's being tested.

Yeah.

Great. Thank you.

Okay.

I'm showing no further questions at this time I would now like to turn the conference back over to <unk> for closing remarks.

Thank you. So we really appreciate your participation in today's investor call and your interest in <unk>. We believe we have a really exciting.

Future ahead of us with the <unk> Readouts.

A robust and growing <unk> business with an exciting early stage pipeline and a really strong balance sheet and so we.

I look forward to to maintain the engagement and keeping you abreast of our.

Our accomplishments going forward. Thank you.

Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

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Good day and thank you for standing by welcome to the <unk> second quarter 2023 earnings call. At this time all participants are in listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during this session.

You will need to press star one on your telephone you will then hear an automated message advising your hand is raised.

Draw. Your question. Please press Star one again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, David de Lucia. Please go ahead.

Good afternoon, everyone. Thank you for joining today to discuss our second quarter 2023 financial and business results.

David <unk>, <unk>, Vice President of corporate <unk>, and Investor Relations at fiber John .

Joining me on today's call are <unk>, our interim Chief Executive Officer, Juan Graham, Our Chief Financial Officer, Dr. Marc <unk>, Our Chief Medical Officer, Dr. John Hunter, Our Chief Scientific Officer, Chris Chung, Our senior Vice President of China operations, and Enrique Conterno, our outgoing chief.

Executive Officer.

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 forward looking statements about fiber Jen <unk>.

Such statements May include but are not limited to our collaborations with Astrazeneca and Astellas financial guidance.

<unk>.

The initiation enrollment design conduct and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities 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.

A more 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.

<unk> dot com with that I would like to turn the call over to Enrique Conterno.

Thank you, Dave and good afternoon, everyone.

First I would like to take a moment.

To thank my <unk> colleagues.

Thank you for your commitment and dedication during my tenure as CEO .

It is important for me to highlight that despite the setback we have recently faced.

I remain enthusiastic about <unk> opportunities.

Given our.

Our remaining near term readouts.

From a revenue of trials with Duchenne muscular dystrophy and pancreatic cancer.

A thriving Brooklyn <unk> business in China.

And our exciting early stage pipeline.

Furthermore.

We have a strong cash position.

That allows us to see through the evolution of our pipeline as well as our talented team across the board.

I am proud of the quality of our leadership team.

Im delighted.

<unk> will be leading fiber Jen <unk>.

As interim CEO .

I have known <unk> for over 25 years.

And have worked closely with him at <unk> during Q3 years, a chief commercial officer.

And at Lilly.

10 years in his capacity as Chief marketing officer for Lilly diabetes.

Where he launched several blockbuster medicines during a period of odd percent that growth of lilly's diabetes business.

During our time to working together.

I have I appreciate it <unk> judgment.

<unk> business ink sinks.

On ability.

To lead organizations effectively.

So.

Without further delay I would like to pass the call to Mr. <unk>.

Thank you Enrique for all that you have done for fiber churn over the past three years.

<unk> built an outstanding leadership team created a performance oriented culture and built our early stage pipeline and personally I have had the benefit of working with you for the better part of the past 14 years at Lilly and here at <unk> and I will do my best to lead fibers toward a bright future.

I am personally excited about the opportunities we have in front of us to bring value to patients and create value for shareholders. Many of which we will highlight in this call.

Our exciting early stage oncology pipeline, providing a perspective that we have not yet discussed in this type of forum.

Lastly, one gram our CFO will review the financials after which we will open the call for your questions.

Starting on slide three.

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

First is <unk> with three upcoming late stage Readouts, starting this quarter and through the first half of next year.

Each indication, which I will walk through in more detail in the coming slides represents a significant commercial opportunity in diseases of substantial unmet need.

Second just rocks produced at <unk>.

This license also includes a biomarker driven opportunity through the development of an associated biomarker diagnostic.

In addition to FG $32 46, we are also undertaking IND, enabling activities on two innovative oncology molecules with the intention of commencing clinical activities in 2024.

Fourth is our strong cash position post ours efforts one results we have implemented a companywide cost reduction plan that extends our cash runway into 2026, which provides the company a bridge to achieved numerous value inflection points across our portfolio.

We have taken the necessary steps to improve our strong financial position and we will continue to focus on financial discipline and.

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 <unk>. We believe that we have a strong foundation to drive significant shareholder value.

Creation today and into the future.

Moving to slide five <unk> is an anti CTG human monoclonal antibody in clinical development for the treatment of ambulatory Duchenne muscular dystrophy, more DMD locally advanced unresectable pancreatic cancer or lap PC and metastatic pancreatic cancer.

<unk> has been studied in over 1000 patients and has demonstrated a favorable adverse event and safety profile, including in patients who have been dosed for up to seven years.

On slide six I would like to provide a recap of recently announced <unk> results as well as review our upcoming milestones.

In June we reported topline data from our phase III <unk>, one study a placebo controlled trial of <unk> for the treatment of non ambulatory patients with DMD background corticosteroids.

<unk> did not meet the primary endpoint of performance of the upper limb to score at week 52 compared to baseline.

In June we announced top line data from <unk>, one study in IPF.

The study compared treatment with <unk> to placebo and did not meet the primary endpoint of change from baseline in forced vital capacity or <unk> at week 48, with a P value of 0.29.

The mean decline in FCC from baseline to week 48 was 260 ml in the <unk> arm compared to 330 ml and the placebo arm correlating to a placebo corrected difference of 70 ml.

Based upon these results we just continuous efforts to our second phase III IPF clinical trial, we would like to thank the patients and clinical trial investigators for their dedication and participation in both of these IPF trials.

Looking ahead, we anticipate upcoming results from three <unk> trials, we expect topline data from Atlanta to an ambulatory DMD later this quarter.

We expect results from LAPIS and <unk> in the first quarter of 2024.

And we expect results from the pancreatic cancer action networks precision promise adaptive trial platform evaluating <unk> and <unk>.

<unk> first line and second line settings in combination with standard of care for patients with metastatic pancreatic cancer in the first half of 2024.

I will now go into each of these opportunities in more detail starting with Duchenne muscular dystrophy.

DMD is a rare and debilitating neuromuscular disease that affects approximately one in every 5000 newborn boys.

About 20000 children are diagnosed with DMD globally each year.

The payroll disease is caused by a genetic mutation leading to the absence or defect of dystrophin.

Protein necessary for normal muscle function.

The absence of dystrophin results and muscle weakness.

Loss fibrosis and inflammation.

As with DMD are often wheelchair bound before the age of 12 and their progressive muscle weakness may lead to serious medical problems related to respiratory and cardiac muscle.

On slide eight.

We note that will lantus to enrolled 73 ambulatory DMD patients six to 12 years of age.

The primary endpoint is the Northstar ambulatory assessment.

A measure of ambulatory function and we expect top line results later this quarter.

Given the devastating nature of DMD and the relentless progression of the disease. We are hopeful that we will <unk> two phase III study can lead to a regulatory filing and ultimately provide a desperate need desperately needed therapy for these patients.

On slide nine we provide a perspective of the commercial opportunity for <unk> in DMD.

There was a clear need for dnb therapies that can attenuate disease progression by targeting the downstream pathological changes to improve muscle function.

We are hopeful that the anti fibrotic mechanism of <unk> may be a treatment that can help these patients and their families and represents a significant commercial opportunity for <unk>.

Moving on to pancreatic cancer on slide 11.

On slide 12, we would like to provide a brief overview as to why we believe an anti <unk> antibody like Pam <unk> would provide benefits to patients diagnosed with pancreatic cancer.

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

Mouse 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 the use in both LAPD.

<unk> and metastatic pancreatic cancer.

Moving to slide 13.

Late stage trials are being conducted with <unk> and both <unk> and metastatic patients.

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

Given <unk> potential opportunity to treat a vast majority of patients across this devastating disease.

Primary endpoint is overall survival and we expect topline data from this study in the first quarter of 2024.

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

This is a phase two three registration study with an FDA approved study design.

Primary endpoint is overall survival, which represents a definitive registration endpoint.

<unk> combination therapy is offered to patients as either a first or second line treatment option.

<unk> was the first experimental treatment arm to be offered as a first line treatment in pan cancer innovative precision promise trial.

We expect topline data from this study in the first half of 2024.

On Slide 16, we review the commercial opportunity for <unk> in pancreatic cancer.

This creates a potential multibillion dollar commercial opportunity for <unk>, if it can demonstrate a significant improvement in overall survival and either locally advanced or metastatic patients.

Moving on to <unk> on slide 18.

I would like to provide a recap of recently announced Roxanne just at results as well as review our upcoming milestones.

In May we announced topline data from our Matterhorn phase III clinical study of <unk> for treatment of anemia in patients with transfusion dependent lower risk Myelodysplastic syndromes.

The study did not meet its primary efficacy endpoint.

<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.

I am pleased to announce that we have filed a supplemental new drug application with the China Health authority for <unk> in patients with chemotherapy induced anemia and expect approval in mid 2024.

We believe this indication could represent a meaningful incremental net revenue opportunity.

<unk> produced at a potential pathway to achieving over $500 million in annual net sales in China.

Moving now to slide 19, <unk> for anemia of chronic kidney disease continues to perform extremely well in China.

Second quarter total <unk> net sales in China by fiber Jen and the distribution entity jointly owned by <unk> and Astrazeneca was $76 4 million compared to $53 1 million in the second quarter of 2022, an increase of 44%.

This growth was driven by an increase in volume of over 40%.

<unk> portion of <unk> net product revenue in China was $23 9 million for the second quarter on a U S GAAP basis.

Moving to slide 20, <unk> just it remains the category leader in brand share in China rising to 39% in the second quarter of 2023.

I would like to briefly touch on <unk> in Europe .

In addition to the continued outstanding performance of <unk> in China. The rocks just didn't launch in Europe is accelerating showing robust quarter over quarter growth we.

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

<unk> is the only <unk> indicated in the EU for the treatment of anemia of <unk> in both non dialysis and dialysis patients and.

And with Gsk's recent decision to withdraw the MAA for that produced at <unk>.

Combined with market exclusivity for <unk> beyond 2030, <unk> as you said is well positioned to continue its growth throughout this decade.

Moving to slide 22, and our early stage oncology pipeline.

On May eight we announced that <unk> entered into an exclusive license with cordis therapeutics for FG $32 46.

Potential first in class opportunity that our CSO, John Hunter will describe in more detail on the next few slides.

Under the terms of the agreement there was no upfront cash consideration.

Fiber general conduct and fund future research development and manufacturing of FG, 32, 46, and an associated biomarker pet 46.

We have the option to acquire Fortis during the four year evaluation period for $80 million.

We anticipate the initiation of a phase III trial in metastatic castration resistant prostate cancer or <unk> in the second half of 2024 with the potential for additional trials targeting other CD 46 expressing cancers.

I will now hand, the call off to John to cover our early stage pipeline.

Thank you.

Moving to slide 23, our recently in licensed clinical program at June $32 46 is an antibody drug conjugate or ADC comprised of an anti CD 46 antibody y S. Five linked to the anti mitotic agent and then <unk>, which is a clinically and commercially validated ADC.

The CD 46, epitope targeted by <unk> $32 46 is expressed at high levels and a majority of metastatic castrate resistant prostate cancers and colorectal tumors and is also found at high levels in a subset of other solid tumors.

Moving to slide 24 ft.

<unk> $32 46 has demonstrated monotherapy clinical efficacy in multiple myeloma in metastatic castration resistant prostate cancer.

Shown here are interim data from the ongoing phase one trial in prostate cancer.

Four out of 21 Evaluable patients had a partial response based on resist criteria and where at PSA 50 response rate of 45% was observed.

Patients in this phase one study were heavily pretreated with a median of five prior therapies.

The safety profile for FTE $32 46 was consistent with other MMA based ADC therapeutics with neutropenia being the most common adverse event additional data from the trial will be reported upon completion.

Moving to slide 25, we show ongoing and planned clinical trials for FTE $32 46 and.

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

The rationale for this combination is based on preclinical data demonstrating upregulation of CD, 46% and tumor cells. Following <unk> treatment, therefore, potentially making them more responsive to treatment with FG $32 46 initial.

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

There is currently at Pet biomarker study trial and progress for the program also being run at UCSF. The pet imaging agent is comprised of the CD 46 targeting antibody y S. Five coupled to zirconium 89.

The goal is to develop a screening assay to select patients with ICD 46 expression, who are most likely to benefit from treatment with FG 30 to 46.

Biomarker will be part of the phase II study run by five Virgin and which up to 100 patients will be enrolled following a pet scan at 46.

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

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

Moving to slide 26, I would like to spend some time on our preclinical oncology program.

The first program I'd like to discuss is <unk> $31 65, an anti <unk> antibody developed to reverse immune assistance in solid tumors.

<unk> nine per gallon.

As 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 FG.

<unk> 31, 65 has been shown pre clinically to reverse multiple gale nine mediated mechanisms of immune suppression, including the prevention of <unk> mediated effector T cell <unk> and Tim three dimerization, we will present preclinical data for this program at a cancer Immunotherapy conference.

Later this year and are working towards a first quarter 2024, and the SEC filings.

Moving to slide 27, and our CCI program.

<unk> is a receptor that is highly expressed on tumor infiltrating T regulatory cells known as T. Reg.

Very limited expression outside of the tumor microenvironment.

<unk> 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.

Given the highly competitive clinical landscape for antibodies targeting <unk> <unk>.

Have developed optimized versions of our previous FG $3 63 during its development.

<unk> thousand 163 has been shown to have acceptable potency and monotherapy efficacy in a preclinical model of colorectal cancer, we decided to advance FG 31, 75 is our clinical candidate as we feel it has a market competitiveness competitive advantage based on relative potency and projected.

Clinical dosing.

Given its highly specific targeting of T. Regs in the tumor microenvironment, we see FG 31, 75 is having broad therapeutic potential in solid tumors I will now turn the call over to Juan to discuss the company's financials.

Thank you John .

Good afternoon, everyone I will jump straight into the quarter's financial results for.

For the second quarter of 2023 total revenue was $44 3 million compared to $29 8 million for the same period in 2022.

A robust increase of 49% year over year.

I will now provide further detail on our revenue.

As of Q2 2023, we recorded $23 9 million of net product revenue for <unk> sales in China compared to $23 3 million in the second quarter of 2022, representing.

Representing an increase of 3% year over year.

During the quarter. We also recorded $14 3 million in drug product revenue for <unk> bulk drug product or active pharmaceutical ingredient sold to astellas.

<unk> drug product revenue was $1 1 million during the second quarter of 2022.

We recorded development revenue of $4 $1 million associated with co development efforts for <unk>.

With our partners as compared to $5 $2 million during the second quarter of 2022.

Finally, we recorded license revenue of $1 million associated with the milestone payment from our biosynthetic cornea program with Illumina X.

Given the strong performance of our business in China, I will provide further context on our financials and performance.

From total <unk> net sales in China fiber dense net transfer price from sales to the J D. E was $23 8 million for the second quarter compared to $18 2 million in the second quarter of 2022 and.

An increase of 31% year over year net transfers met transfer price is the best reflection of fiber <unk> portion of the cash received by <unk> and China.

During this quarter, we deferred $3 3 million in revenue due to the change in our future estimates as per U S. GAAP, primarily driven by unfavorable and favorable reminbi currency impact amongst other estimates.

As we have communicated in the past the deferred revenue balance and fiber Gen. China fluctuates based on management estimates of future revenue.

Now moving down the income statement, our operating costs and expenses for the second quarter of 2023 were $132 4 million compared to $108 million for the second quarter of 2022.

Our operating expenses would be essentially flat year over year.

R&D expenses for the second quarter of 2023 were $95 5 million compared to $71 million in the second quarter of 2022.

<unk> therapeutics, excluding such onetime charge R&D expenses were $79 million for the quarter again, essentially flat year over year.

Of the $79 million of R&D expenses that I, just mentioned approximately 59% was dedicated to <unk> map development and CMC activities, 29% allocated to support our early stage pipeline and the remaining 12% directed towards <unk> development.

Activities in the United States and China.

Given the outcome of the IPF trial suffers one.

Subsequent impact on the termination of separate two we will see a significant reduction in R&D expenses related to primarily the map in the coming quarters.

SG&A expenses for the second quarter of 2023 were $31 2 million compared to $33 million in the second quarter of 2020 to.

Remaining relatively flat year over year.

The impact of the above mentioned, one time charge of $24 $6 million related to the noncash asset acquisition of Fortis represents approximately 25.

Net loss per basic and diluted share.

On July 14, 2023, as part of a broader cost reduction effort, we announced a restructuring plan to lower our operating expenses.

The plan includes an expected reduction to fiber dense U S workforce of approximately 32% or 104 employees.

We estimate that the.

Related nonrecurring restructuring payments to be in the range of $13 million to $15 million.

The majority of which will be incurred in the third quarter of 2023.

On slide 29, I lay out our expected future GAAP savings associated with the reductions I just mentioned.

In the first half of 2023, our average GAAP operating expenses and one time charges were approximately $105 million per quarter.

Excluding onetime expenses and charges, we anticipate expected savings of approximately $100 million to $120 million in total annualized GAAP expenses were $25 million to $30 million per quarter.

We expect to achieve up to 20% of these quarterly savings in the third quarter of 2023, 60% to 80% of expected quarterly savings in the fourth quarter of 2023 and.

And achieve our quarterly expected run rate savings in the first quarter of 2024.

Now shifting towards cash as of June 30, we reported $361 $3 million in cash cash equivalents investments and accounts receivable.

Our cash balance includes the $71 3 million of net proceeds raised through our debt facility with Morgan Stanley tactical value and additional use of our ATM facility during the quarter.

And now we would like to turn the call back over to me.

Okay.

Phase III Atlantis to an ambulatory DMD this quarter.

Ms III LAPIS and la <unk> in the first quarter of 2024.

Phase two three pancreatic cancer action network or Pan can precision promise trial in metastatic pancreatic cancer in the first half of 2024.

<unk> continues to perform very well in China, where we recently filed our NDA for the CIA indication and our partner Astellas continues with the commercialization of <unk> in Europe and Japan.

And our early stage pipeline, we anticipate filing an IND for.

<unk> thousand 165, the anti <unk> antibody in the first quarter of 2024.

We have completed incremental financing transactions to further strengthen our balance sheet and expect our current cash position to fund operations into 2026.

I would like to thank all of the employees of Biogen for their continued hard work and perseverance over the last few months I would now like to turn the call back over to the operator for Q&A.

Rockstar.

Our first question comes from the line of Michael Yee with Jefferies. Please proceed with your question.

Hi, This is Josh <unk> on the line for Michael Thanks for taking my question I think I have two questions if I may.

First for Rux I'll, just add could you help us understand the patent.

The dividend situation for Russia, and China and.

What is your base case for the timing of a potential generic.

Generic entry and what are the ways to extend the exclusivity and then four 446.

Why are you excited about this ADC program and.

And I also noticed you have a phase one well that was a phase one multiple myeloma. So also pursuing the opportunity in this indication.

Are there any other indications that you are thinking about thank you.

Well. Thank you for your question.

The first part of it related to <unk>, China Pat.

Patent term exclusivity generic entry I'd like for Chris Chung to address that question.

Chris Thank.

Thank you thank you Jeremy.

Yes.

Okay. Thank you. So thank you for the question.

Confirm that the health authority and China has affected a number of generic applications <unk> and.

And so it will be of course.

Just to clarify on acceptance in a minute.

State of acceptance.

Filing with Justin Technical review, it's about six months.

It does not represent or approval.

Shape or form.

Our competition matter patent expires in mid 2024.

And then the patent linkage system in China.

Not expecting any generics of Rockford, you set to be marketed until at least after that.

Now of course, the composition of matter patent represents only one of many options that we have in our patent portfolio all of which we intend to defend vigorously in China.

Also a point that I should point out unlike in the U S. There is life.

Thank you Nader brand asset patent expiry in.

In some cases, the volume of the of the Canadian brand actually increases.

Now of course at eight milligrams.

We remain optimistic about our options on inclusivity front.

We are pursuing our intellectual property options and market access tactics to preserve and extend.

Time.

You saw earlier.

Robust growth in market share a piece of <unk> CTD. We believe there is tremendous market potential in that space allows us significant growth.

Of course, CIA representing that the hypermarket.

Back to you.

Thank you Chris.

Related to the question about 446 about why we're excited.

Like for Jon Hunter to address that question and then if mark has any comments after that to add onto that.

John .

Sure. Thanks.

I think one of the biggest points of excitement was really seeing monotherapy efficacy.

Very hard to treat patient population as I had mentioned these patients were heavily pretreated.

And we saw partial.

Funds rate of about 20%.

Very good at PSA is that the response rate.

So that was quite exciting relative to other.

Assets that we're looking at but also the mechanism and it's very well validated as I had mentioned there are I think now five.

Approved adcs that use and then AE is the payload.

Additionally, when we really did a deep dive in the <unk> 46 expression we saw that.

It was quite restricted to tumors for the most part with only a couple of normal tissue tissue, so showing any.

Considerable expression so.

We have an entire package that we felt look very good and we're very excited to bring it in.

I'll talk about potential other indications and then I think I'll turn it over to Mark to address the multiple myeloma question.

We are in fact looking at indications to expand into we have an ongoing translational medicine effort to identify IAA.

IHG antibodies that we may use to be able to run a basket trial in patients from other solid tumor indications, where the prevalence of CD 46 expression might not be as high but where we can select patients who do have that high expression to enter into the trial.

Our very early efforts, so we will hotels.

As they progress and now Mark I'll hand, it over to you for any additional comments.

Yeah, Thanks, Jon I mean, I think we're.

I'm also very excited about the molecule because or the ADC because it has several potential ways to help patients too.

To really add value to fiber Gen. One is as you said.

Metastatic castrate resistant prostate cancer in mono therapy.

Other one is in Enzo combo therapy, which is a current ongoing study at UCSF as you mentioned the other one is either a solid tumors <unk> multiple myeloma, so multiple diseases seem to be driven by <unk> 46. This is a very novel ADC.

We have a parallel pet imaging biomarker strategy that we're pursuing so I think theres, a novelty and a deep biology underlying this program that's very exciting.

And I think maybe just to conclude related to the excitement for the for this asset is the favorable deal terms with no upfront cash consideration success based milestones and the opportunity over a four year period of evaluation to potentially acquire the company for $80 million. In addition to.

Obviously, what John and Mark just spoke about.

We're really excited about the opportunity.

Alright, thank you.

Can I follow up on the first one.

Is there any way to extend your exclusivity for Rockstar win.

After your CIA indication gets approved.

Okay.

So how should we be thinking about it.

No.

There is eight.

Intellectual property law in China.

With activated in 2021.

At this point in time, the regulations is not yet implemented.

So we are not.

Looking at those opportunities with F 18, I think that decision would come down to what.

Chinese company eventually decides to implement.

Okay. Thank you.

One moment for our next question.

Okay.

Our next question comes from the line of yarn Werber of TD Cohen.

Please proceed with your question.

Hi, This is joey on for your own. Thanks, so much for taking our question.

Maybe just a couple from US first on the CIA can you tell us about your latest thinking around whether this is ultimately going to be a China only strategy.

You are thinking that this is going to come to the U S as well.

And then for the LAPIS study could you just quickly remind us about the potential use of event free survival.

As a surrogate for accelerated approval. Thank you.

Yes, Thanks, Joyce related to CIA.

But right now as a China only opportunity and Mark would you like to touch on the <unk>.

Question on that LAPIS, yes. So the question has to do with the primary endpoint of this study which is overall survival as we'd mentioned in an earlier call. We did do an interim analysis for event free survival as a potential surrogate marker. It was a very high bar analysis that did not meet that analysis. So we're continuing the trial for.

<unk> overall survival as the primary endpoint and we expect that to readout in first half of next year.

Great. Thank you.

One moment for our next question.

Okay.

Our next question comes from the line of Jason <unk> of Bank of America. Please proceed with your question.

Oh, Hey, guys. Thanks for taking my question.

Just coming back to the patent.

Topic in China is the process with the generic challengers.

Entirely an issue of patent validity and if the patent is found valid then.

There is a barrier until the expiry of the crystalline form IP or is there a potential avenue if those generic challengers have defer non infringing crystalline form molecule if they can.

Potentially have an avenue to be found non infringing just wanted to understand.

That dynamic a little bit better and then <unk>.

On Pam Rev for ambulatory DMD I'm wondering if you could highlight any important mechanistic differences why Pam Rev might be more effect here than say the non ambulatory setting. Thanks.

Thanks, Jason Chris If you could take the first question.

Absolutely.

So with respect to generic challenges, so first and foremost our composition of matter patents.

Is is valid.

All generic applicants on the patent linkage.

Our system in China have to crop up we respect those patents.

That is a fact and this is why we're very comparable.

Generic on the market after that.

With respect to the Crystal lines Hopkins, Chris My package are not considered part of them has to make a system.

Well not enforceable.

The heart of Dougherty.

Forcible either quite long and that is what we will have to pursue.

As to whether a generic apathy could potentially has eight Chris Mike warm and alternative polymorph.

Platforms that could get around us that unfortunately, I think the question.

Rapid deferred to the passenger journeys <unk>.

I hope that's helpful.

So thats. The other question was around ambulatory versus non ambulatory DMD and.

I think we've always said that we expected non ambulatory DMD to be the most challenging because the patients have already lost so much function narrow wheelchair bound in the signal to noise ratio of the endpoint the performance of the upper limb.

We expect it to be a challenge and turned out to be a challenge. We also didn't see any clinically meaningful efficacy in terms of the other secondary endpoints, including FPC percent predicted.

Ejection fraction by cardiac MRI. Unfortunately.

<unk> out for all of us at <unk>, because we're really opening to be able to deliver a therapy for these patients with non ambulatory DMD, which is so desperately needed. So now we turn our attention to ambulatory DMD, where because these are younger patients. They already are they still have much more function I think the northstar ambulatory.

Tori assessment is a more holistic type of endpoint, we do feel like we still have a possibility of showing a benefit in this patient population and we're really looking forward to those top line results in the near future.

Got it thank you.

One moment for our next question.

Okay.

And our next question comes from the line of Annabel <unk> of Stifel. Please proceed with your question.

Hi, Thanks for taking my question just while we're on the DMD topic.

I guess.

One of the things we're wondering is.

And the ambulatory DMD.

Trial, you don't necessarily see function, but you see benefit on some of these other markers such as injection fraction RPC.

Can you see an avenue for filing on that.

And in the non ambulatory.

Understanding that the non ambulatory is more challenging.

That was the second injection fraction are they is it also more challenging.

On those measures as well.

Or was.

Was it strictly on that on the functional endpoints.

You were referring to.

Thank you.

Yes, so I'll try to address both of your questions. So the second part first yes, I think that all endpoints are going to be more challenging in the non ambulatory population in the ambulatory.

I'll say that the cardiac MRI is not really.

The same relevance for the younger patients who are aged six to 12, because that's a relatively cardiac manifestations are relatively later manner.

Manifestation in the disease for ambulatory, it's the Northstar.

Stair climb 10 meter walk other other endpoints like that are the primary and secondary endpoints.

So.

Ultimately the North Star I think has been quite well looked at in the setting of <unk>.

Other studies and we expect that.

It's a validated endpoint and we're looking forward to those results.

Okay sorry.

Is there any avenues for you to file as Youre seeing secondary benefits.

Let's go to the Northstar.

Alright.

Regulatory pathways with the FDA, so it'll be a data driven decision, but we of course will look at all of the endpoints and.

Really look for any signs of efficacy in that trial, that's coming up.

Okay, and then if I can ask one more question with regard to <unk>.

<unk> is an anti fibrotic agent are there any other markers that you looked at.

From the Atlanta, one trial.

Given that give you an idea that there is there is actually anti fibrotic activity and I couldnt help but since the confidence about.

Just going into the trial and so I'm just wondering if you saw anything else that that 80 some odd.

Okay.

Unfortunately, the relentless one probably is really there was no end point that really.

Showed any signs of efficacy it may be due to the non ambulatory population and how advanced it is.

I think the ambulatory <unk> II trial data will really help us to answer what clinical benefit in an otherwise can be shown in DMD. So I think the studies will together or tell the full story. So we have half the answer.

Eagerly awaiting the rest of the information from all <unk>.

Okay, great. Thank you.

Thank you for the questions.

One moment for our next question.

Okay.

Our next question comes from the line of Alexandra Ramsey from William Blair. Please proceed with your question.

Hello. This is Alex Ramsey on for Andy Hsieh, William Blair. So a couple of questions from US you don't mind. So the first question is about the term loan with Morgan Stanley 's tactical value.

Just curious about the status of the $75 million initial term loan.

There are any plans to pay back that one earlier than in May 2026, maturation date or it does take to hit by the terms of the loan.

And then second Mark on Libre curious to hear if you have any insights on that first data and if you have any hypothesis in terms of why it's underperformed.

And we definitely understand that are probably early in analysis and we're just wondering if anything's popped out sharing the initial analysis increments.

Yes, Thanks, Alex I'll have one address the <unk> question, and then turn it over to Mark.

Hey, Alex Yes on the term loan as you pointed out we have an initial draw of $75 million that ASP has actually occurred.

Jeff.

At the beginning of May may eight I believe it was we received a $75 million.

So thats why do we would expect to hold on to until term maturity.

At this point in time, there is no plan for early repayment.

Thanks, a lot mark right. So.

In terms of the Zephyrus, one study, yes disappointing results in terms of the primary endpoint and the secondary endpoints none of them most of which showed kind of numerically better results for Pam versus placebo, but none of which were statistically significant.

The kinds of <unk>, there were three major issues going into the trial that I think we and everyone was focused on number one was would the placebo decline at 48 weeks in Zephyrus one.

Be adequate to show a treatment effect and it was it was 330 ml decline, which compare it very similarly to <unk> 308 ml. The second point was the influence of prior history of standard of care in about half the patients where treatment experienced about half were treatment naive and that really made.

No real meaningful difference on the results and then the last point that I think was a lot of focus are what about those patients who started the standard of care on study that turned out to be about 14% started <unk> on study and again that did not make any meaningful difference in the study results. So the top three.

Things, we were really focused on and I think the.

Analysts and Investor community was focused on really turned out to be within what we would have predicted. So at this time, we don't have any clear reason why the surplus results were less significant than the.

Praise results, except to say that.

The phase II to phase III translation in this disease IPF is very very challenging if you look at the Galapagos Gilead or you look at the Roche data they've run into similar challenges and I don't think these charges are completely understood at this time.

Alright got it. Thank you so much very helpful.

Thank you for the question.

One moment for our next question.

Yes.

Our next question comes from the line of Paul Choi with Goldman Sachs. Please proceed with your question.

Hi, Thanks, good afternoon, and thank you for taking our questions.

Maybe returning to the subject to <unk> for a minute.

Two.

Is there any component of the North star.

You think where perm revenue might show particular benefit any any gleaning fare.

Ambulatory population would be helpful.

Alright, well the short answer Paul is we really don't know I mean, the total score is designed for the total score.

We will be looking at data will also be looking at.

Pardon me 10 meter walk the stair climb other components, but at this point in time, it's difficult to answer that question I think we'll have to await the data.

Okay fair enough.

And then turning to your oncology pipeline in FTE at $32 46, Youll have the combination study with <unk> next year.

Just curious if you can maybe sort of frame expectations for what what responses might look like whether it's on PSA or how youre thinking about comping the results versus either monotherapy studies or other.

Extending Sundays with came out any any framework or context would be appreciated. Thank you.

Yes, Thanks, Paul I'll have John address that second question.

Sure, although I think mark might have better insight into it but just with regards to how we're viewing it.

We kind of have a baseline now with the monotherapy results and we know what.

To expect with.

At 2246 alone so really I think with the extend the combination will be looking to see if there is additional benefit and.

And we'd be looking both at the PSA 50, and overall response rate given that we did see those in the.

Earlier phase one trial.

Mark you might want yes.

Sorry, John I was just because they have exact same perspective, if it does increase $2 46 expression.

<unk> that is that we could expect to see a greater degree of clinical efficacy. That's the hypothesis that's being tested.

Yeah.

Great. Thank you.

Okay.

I am showing no further questions at this time I would now like to turn the conference back over to <unk> for closing remarks.

Thank you. So we really appreciate your participation in today's investor call and your interest in <unk>. We believe we have a really exciting.

Future ahead of us with the <unk> Readouts.

A robust and growing <unk> business with an exciting early stage pipeline and a really strong balance sheet and so we look forward to to maintain the engagement and keeping you abreast of our.

Our accomplishments going forward. Thank you.

Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Q2 2023 FibroGen Inc Earnings Call

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