Q3 2022 argenx SE Earnings Call

October 27, 2022

To prevent any background noise. After the Speakers' remarks, there will be a question and answer session. If you'd like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question again press Star one. Thank you I'd like to introduce Beth Dell Jocko.

Good morning, My name is Rob and that'll be your conference operator today at this time I would like to welcome everyone to the call all lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you'd like to ask a question. During this time simply press star.

He is president of corporate Communications and Investor Relations you May begin your conference.

Followed by the number one on your telephone keypad, if you would like to withdraw your question again press Star one. Thank you I'd like to introduce Beth <unk>, Vice President of corporate Communications and Investor Relations you May begin your conference.

Thank you operator, our press release was issued earlier today with our third quarter 2022 financial results and business update this can be found on our website along with the presentation for today's webcast.

Before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call. These may include statements about our future expectations clinical development regulatory time line.

Thank you operator, our press release issued earlier today with our third quarter 2022 financial results and business update this can be found on our website along with the presentation for today's webcast.

The potential success of our product candidates financial projections and upcoming milestones.

Before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call.

Actual results may differ materially from those indicated by these statements <unk> is not under any obligation to update statements regarding the future to conform those statements in relation to actual results unless required by law I'm joined on the call today by Tim Van Harrow Marin Chief Executive Officer.

Statements about our future expectations clinical development regulatory time line.

The potential success of our product candidates financial projections and upcoming milestones.

Actual results may differ materially from those indicated by these statements. Our Genesis is not under any obligation to update statements regarding the future to conform the statements in relation to actual results unless required by law.

Carl <unk>, Chief Financial Officer, and Keith <unk>, Chief Operating Officer, I will now turn the call over to Tim. Thank.

Thank you Beth and welcome everyone as we approach the end of the year. We are pleased to be here today with a message of consistent pipeline and commercial execution.

I'm joined on the call today by Tim The Harrow Merritt, Chief Executive Officer, Carl <unk>, Chief Financial Officer, and he was Chief operating Officer, I'll now turn the call over to Tim.

Over the last three quarters.

We continue to deliver strong results from our global fleet stop loss.

Thank you Beth and welcome everyone as we approach the end of the year. We are pleased to be here today, but the message.

Making progress towards our goal of bringing a paradigm shifting treatments.

Pipeline and commercial execution.

People living with generalized myasthenia gravis, we set out at the beginning of the year to prove that we could launch a drug but with our experience.

Over the last three quarters.

We continue to deliver strong results from our global Kids got loss, making.

Making progress towards our goal of bringing a paradigm shifting treatments to people living with generalized myasthenia gravis, we set out at the beginning of <unk>.

Our strategy.

We could transition into a global integrated immunology company.

Now please full quarters and keep alone.

We have generated almost $230 million.

Hope that you could launch a drug that without it.

Net product revenue.

Of course strategy.

Demonstrating our capabilities as an organization.

We could transition into a global integrated immunology company.

Then beyond antibody engineering, immunology research and clinical development and.

Now please.

Alone.

We have generated almost $230 million.

And into bringing in new therapies, and new modality to patients.

Yeah.

Thank you.

Demonstrating our capabilities as an organization extend beyond antibody engineering, even though what's your research and clinical development and into bringing this therapy and new modality to patients.

Slide four.

We have identified key drivers of our launch success, which we hope to replicate as we plan for the dissipated approval and launch of our <unk> products in the first half of next year.

Platform.

First.

We have identified three key drivers of our launch success, which we hope to replicate as we plan for it.

The unmet need and severity of the disease was even more significant than we realized in.

And the demand for a new treatment option has been high.

The approval and launch of our <unk> products in the first half of next year.

During the third quarter.

Cost of two thousands mark of patients on drug globally.

First.

The unmet need us most.

We eat every day of debilitating diseases and in fact, our market research shows <unk> second only to <unk> as the worst disease neurology suite.

Even more significant than be realized and the demand for a new treatment option has been high.

During the third quarter.

The 2000 and mark of patients on drug globally.

We eat everyday how debilitating diseases and in fact, our market research shows that <unk> is second only to <unk> is the worst.

Many patients gives us some drops.

Due to the some benefits symptoms of side effects from current medications.

Steady client walking support of feeding tubes, because they have difficulty swallowing.

Neurology.

Many gmg can give us on <unk>.

Many patients gives us some jobs due to the synthetic of symptoms or side effects from current medications.

So out of work to provide full time care to the local level.

To quantify this burden we have invested a lot of fun and gathering rewards evidence, which has corroborated the anecdotes, we hurt on significant loss of productivity and impact on quality of life.

They require walking support for feeding tubes, because they have difficulty swallowing.

Many gmg caregivers are also out of work to provide full pan cancer their loved one.

Second the.

To quantify these burden you have invested funds in gathering greenwald evidence, which has got operator.

The bids are data over there it is.

Health care providers.

We are setting a new standard of treatment based on the efficacy and safety profile observed in the debt and the debt plus.

Yeah.

On significant loss of productivity and impact on quality of life.

These data options trading in clinical practice.

Okay.

The data opportunity with health care providers.

We have positive feedback from physicians on this.

I think in the standard of treatment based on the efficacy and safety profile observed in the debt and the debt plus.

Speed of onset and depth of response.

Including patients achieving minimum symptom expression.

Perfect.

And these data are translating in clinical practice.

40% of all treated patients achieving MFC into that after just one treatment cycle.

We have positive feedback from physicians.

You don't answer and depth of response.

This is quickly becoming an essential outcome measure for patients and physicians.

Including patients achieving minimum symptom expression in fact, you have 40% of all treated patients achieving MFC in the debt after just one treatment cycle.

And third.

The core strategies, we put in place appear to be the right one and we have strong engagement with our patients physicians and payors.

This is quickly becoming an essential outflow measured for patients and physicians.

This will provide updates on the strategy.

Very proud of our cross functional team, which has worked closely in collaboration to achieve these results.

And third.

Our core strategies, we put in place appear to be the right one and we have strong engagement with our patients physicians and space.

Slide five.

As you know we believe <unk> is just the beginning for gift cards and next year will be a busy year with label expansion opportunities.

This will provide updates on these strategies.

Very proud of our cross functional team, which has worked closely in collaboration to achieve these results.

Top line data are expected from our ongoing registrational trials in CIP.

Slide five.

As you know we believe <unk> is just the beginning for <unk> and next year will be <unk> with.

ITT and PV.

And each of these indications represents a sizable opportunity given the treatment gap station toothpaste.

With label expansion opportunities.

Top line data are expected from our ongoing registrational plasma T.

The implemented innovative trial designs across the board.

This will provide us with important data for physicians in how they treat their patients.

And PV.

And each of these indications represent a sizable opportunity given the treatment gaps patients face.

This is the year, we continue to anticipate top line results from TLLP in the first quarter of 2020.

The implemented innovative trial designs across the board.

Slide six.

It will provide us with important data for physicians in how they treat that patient.

We didn't have any learnings from precedent trials to designers.

This is Ian.

Great.

Patients need to have confirmed exports to MVP.

We need to anticipate top line results from <unk> in the first quarter of 2020.

Order to evolve into stage II.

Well they must demonstrate that we are exposed to asbestos removal.

Slide six.

Really hasnt been the learnings from precedent trials designed that way.

Reported interest HB.

In stage IV patients are randomized to stay on a practical.

Patients need to have confirmed access the IDP.

We'll switch to placebo.

Order to enroll into this page eight.

And the study stop sponsored <unk>.

Well, they must demonstrate supposed to adaptive jamal before advancing to CHP.

In terms of relapses.

Remember this is an event driven trial.

<unk> means to monitor the rate of dropouts to assess timing to data.

In stage IV.

Patients are randomized to stay UNICEF pick them up.

We will of course continue to update you on this timing that's necessity.

Or switch to placebo and the study stop sponsors 88 events of relapses.

We are also expecting top line results in the second half of 2020 see from our second back repeat trial defined sub Q.

Remember this is an event driven trial, which means the monitor the rate of dropouts due us responding to data.

We will of course continue to update you on this timing necessity.

The two advanced studies will support registration India.

Slide seven highlights the results from the first advance IV trial.

We are also expecting top line results in the second half of 2020.

Our second ITC trial.

Dosing activity and report the data from the advance study made we hope an advisory board to gain feedback from the hematology community.

So Q.

To advance study will support registration India.

Slide seven highlights the results from the first advance IV trial.

The physicians were very excited by the fast onset of action and pleased separation between the platelet counts of treated patients and placebo throughout the study.

Totally activating all the data from the advance study in May we hope an advisory board to gain feedback from the hematology community.

We're also encouraged by the safety profile, which was consistent with what we observed in attacks consensus was that these data support positioning of <unk> as a third line treatment option. After his first PPO.

The physicians were very excited by the fast onset of action and please separation between the platelet counts of treated patients and placebo throughout the study.

There were also encouraged by the safety profile, which was consistent with what we observed in the consensus was that these data support the positioning of this stock as a third line treatment option.

David greed that depending on additional data there could be potentially in earlier line patients as well on slide eight.

Many of the physicians on our advisory board with part of the ITT International working group.

If first key deal.

David Lee.

Was formed to build assessment criteria of clinical trials more aligned to clinical practice.

Turning on additional data that could be potentially in earlier line patients as well slide eight.

The items, which include that the goal of an ICT therapy.

Many of the physicians on our advisory board with part of the ITT International working group that was formed to build assessment criteria of clinical trials more alive to clinical practice.

You can do to get patients to assess platelet counts two presents clinically significant bleeding.

To do so with business toxicity.

In advance.

Yeah, Adam to achieve that.

61% of treated patients, whereas only based on <unk> criteria.

So the goal of an ICP therapy should be to get patients to assess platelet counts.

Defined as achieving platelet counts over 30.

As clinically significant bleeding.

A two fold increase from baseline.

And to do so with business toxicity.

In the absence of any bleeding.

In advance.

This <unk> honestly resonated, particularly well with our dermatologists.

1% of treated patients, whereas almost based on <unk> criteria.

Finally, achieving platelet balanced over 30.

And further support our expected <unk> positioning with Invesco funds, because we expect data in the second half of 2020 as both slightly.

A two fold increase from baseline.

The absence of any bleeding.

This is Adam <unk> full suite resonated, particularly well with our Hematologists and further support our expected this acquisition with addressable funds.

Slide nine.

This is an indication where the launch translation studies to uncover more of a cathedral months based on the beautiful emissions, we observed in phase III.

We expect data in the second half of 2020 as well slightly.

In these patients.

Auto antibody levels did not return to baseline in the same way as total RTG level.

Slide nine.

This is an indication where we launched translational studies to uncover more modest cathedral based on the beautiful emissions, we observed in phase II.

Looking deeper this correlated with the reduction in the Autoreactive T cells, which are it's answerable to producing the auto antibody.

In these patients.

Auto antibody levels did not return to baseline in the same way as total RTG level.

We are now looking more broadly across the indications.

If you observe a similar disease modifying the outcome.

Looking deeper this is correlated with the reduction in the Autoreactive T cells, which are responsible for producing the ultra antibody.

This type of transportation work is part of who we are as a company.

Through our commitment to both patients and the sites we have.

We are now looking more broadly across the indications.

Want to advance our leadership in <unk> biology, with new data and publications on the differentiation of our FC fragment.

If you observe a similar disease modifying output.

This type of transformational work is part of who we are as a company.

You also see our commitment to immunology innovation with our early stage pipeline and our fiber program bulk.

Through our commitment to both patients and the science.

<unk> leadership in Upselling biology, with new data and publications on the differentiation of our FC fragment.

Both of which emerged from our immunology innovation program.

Our partner programs can take two forms whether the licensing relationship or the spinoff company.

You'll also see our commitment to immunology innovation with our early stage pipeline and our partner programs.

<unk> and <unk> assets.

Slide 10.

Of which emerged from our immunology innovation program.

Our journey from 17 is our first in class sweeping antibody targeting <unk> in the complement cascade.

Our partner programs can take two forms whether the licensing relationship or the spinoff company based around <unk> assets.

Last year, <unk> phase, one data, indicating the repeat dosing.

Slide 10.

We can reduce <unk> levels by over 95% for a sustained period of time.

Our journey from 17 <unk>.

First in class sweeping antibody targeting <unk> in the complement cascade.

This would indicate the potential photodetector dosing profile.

Last we are assured phase one data, indicating that the repeat dose.

We are currently evaluating our journey from 17 in our phase II trial for the treatment of multifocal motor neuropathy, another very serious neuromuscular autoimmune disease.

We can reduce the two levels by over 95%, but a sustained period of time.

This would indicate the potential for that.

And the second largest ibs D indication within neuro.

Sector dosing profile.

We are currently evaluating <unk> in a phase two.

We believe there's a lot of opportunity with our <unk> inhibitors across several of our therapeutic franchises and we will aim to show the first set of clinical data next year.

Two trial for the treatment of multifocal motor neuropathy, another very serious neuromuscular autoimmune disease, and the second largest ibs D indication with a new.

Rounding up the assets and algorithms for our franchise on slide 11.

We believe there's a lot of opportunity EBITDA reached <unk> two inhibitors.

We are on track to file a cta by the end of the year for our analyst agonist <unk> thousand 19.

Several of our therapeutic franchises.

We will aim to show the first set of clinical data next year.

We will start the phase one trial in the first quarter of 2023 in midstream and assess the patient cohorts at the higher doses.

Rounding up the assets and algorithms for franchise on slide 11, we.

We are on track to file a cta by the end of the year for our enlist agonist <unk> thousand 19.

Including congenital myasthenic syndrome and to Musk Mg.

Slide 12.

We will start the phase one trial in the first quarter of 2023 in which we will assess the patient cohorts at the higher doses.

We are also seeing exciting recent progress with two of our molecules.

With Abbvie advancing our journey from <unk> to the next stage of development.

Including congenital Myasthenic syndrome.

And legal exercise of its option on unchanged pumped up.

Mg lights.

Slide 12.

Also seeing exciting recent progress with two of our molecules.

Fewer baccarat and expire kind of antibody candidates.

We have demonstrated human proof of concept in eighth candidates out of other immunology innovation program.

With Abbvie advancing our Chinese from 15 to the next stage of development and legal exercise of its option on unchanged pumped up.

Revenue in our own hands over deposit.

This is exactly the reason we continue to invest in our innovation engine, because it is efficient and productive with a strong track record to date.

If you look back at our generics pipeline of antibody candidates.

We have demonstrated human proof of concept in eight candidates out of our immunology innovation program.

Revenue in our own or with a partner.

Before I turn the call over to Carl for a financial update.

This is expected to be in we continue to invest in our innovation engine, because we are as efficient and productive with a strong track record to date.

I want to spend a few minutes talking about my co filer on behalf of.

Who will retire at the end of this year.

Our steamships with an incredible legacy of scientific innovation.

Before I turn the call over to Carl for a financial update I want to spend a few minutes talking about my co filers.

Finally, the company based on Big breakthrough in antibody engineering, which has been the backbone to most of our pipeline candidates.

<unk>, who.

We will decide at the end of this year.

So the focus humanity and drive to always learned upon scientific breakthroughs of August .

Obviously interest with an incredible legacy of scientific innovation.

Finally, the company based on this breakthrough in antibody engineering, which has been the backbone to most of our pipeline candidates.

Level, two assets like <unk> and <unk> 17.

We are very grateful that he will continue as an advisor to our immunology innovation program.

But it was with humanity and drive to always learn about the scientific breakthroughs of August .

Pushing us to find novel disease targets and promising the pathways and that as a strategic advisor to the R&D commentary of our board.

Douglas to assets like <unk>, and our Chinese <unk> 17.

We are very grateful that he will continue as advisors to our immunology innovation program.

We've assumed game from home to sound scientific items.

While we move to the next stage of this release.

Pushing us to find novel disease targets and promising the pathways and as a strategic advisor to the R&D Committee of our board.

We are also fortunate that we have such a strong successes to step into the important role of Chief Scientific officer.

We've assumed game from home to sound scientific guidance.

You can always has been with the company since 2010.

If we move to the next stage of this to me.

Most foundational to the creation of a cathedral and has been committed to the development of a captive <unk> since its creation.

We're also fortunate that we have such a strong successes to step into the important role of Chief Scientific officer.

You want the first subject to be dosed with the drug and has been leading adaptive clinical.

You can always has been with the company since 2010 plus.

Clinical sites since that time.

Most foundational to the creation of the Cathedral and has been committed to the development of a cup that Jim up since its creation.

Conservative the scientific leadership, our neuromuscular franchise.

Strategizing, our cartage amongst our journey from 17 in our Chinese frontline team.

You launched the first subject to be dosed with the drug and has been leading adaptive them up clinical sites since that time.

And most recently took over as head of all critical pilots.

This will be a very natural transition for the company and competent people, who will be working side by side for the next couple of months.

He served as a scientific need of our neuromuscular franchise.

<unk> a cottage amongst our <unk> 17, and our journey from 19.

It has been now for more than a decade.

And most recently took over as head of authentic of pilots.

And with that I will turn the call to Carl.

Thank you Tim our third quarter 2022 of these notes are detailed in today's press release from this morning.

This will be a very natural transition for the company and content people will be working side by side for the next couple of months.

Now I will only highlight the key points here.

Now for more than a decade.

And with that I will turn the call to call.

On slide 18.

You will find global net product revenues compared with current loans for the first three quarters of the year.

Thank you Tim our third quarter 2022 results are detailed in your press release from this morning.

In the third quarter, we generated $131 3 million in global net product revenues, which was comprised of $124 1 million from the UAS $6 million from Japan, and one $2 million from Europe , and our distributor markets.

I will only highlight the key points here.

On Slide 14, you will find global net product revenues from the vet card loans for the first three quarters of the year.

Our third quarter, we generated $131 3 million in global net product revenues, which was comprised of $124 1 million from the U S.

Together with a $21 million from the first quarter and the $75 million from the second quarter.

$6 million from Japan, and $1 2 million from Europe , and our distributor markets.

This puts our year to date global product revenues at $227 3 million.

<unk> with a $21 million from the first quarter and the $75 million from the second quarter.

As with previous quarters inventory in the channel at quarter end to us well managed and reflects less than two weeks worth of vials.

Puts our year to date global product revenues at $227 3 million.

Slide 14.

Total revenues for the quarter $146 5 million, which also include $6 7 million in collaboration revenue driven by a 5 million euro milestone from Leo pharma following the option exercise core organics 112.

As with previous quarters inventory in the channel at quarter end was well managed and reflects less than two weeks worth of vials slide 14 now.

Total revenues for the quarter were $146 5 million, which also include $6 7 million in collaboration revenue driven by a 5 million euro milestone from Leo pharma.

And $8 5 million.

Operating income.

Cost of sales for the quarter was $10 3 million.

Our total R&D and SG&A expenses for the third quarter were approximately $236 7 million and $108 $2 million respectively.

Knowing the option exercise for organics, 112, and $8 5 million.

Operating income.

Cost of sales for the quarter were $10 3 million.

And can mainly be attributed to Epcot tic mode, and as a pipeline <unk> expenses as well as marketing and head count expenses related to our global launch.

Our total R&D and SG&A expenses for the third.

Third quarter were approximately $236 7 million and $108 2 million respectively.

The increase in research and development expenses was mainly driven by the recognition of a priority review voucher.

And can mainly be attributed to <unk> and other pipeline research expenses as well as marketing and head count expenses related to our global launch.

It did with the BLA filing or sub Q it got taken months.

On the cash balance.

Increase in research and development expense was mainly driven by the recognition of a priority review voucher.

We ended third quarter with almost $2 $4 billion in cash cash equivalents and current financial assets.

Method with a BLA filing for sub Q it got taken out.

We continue to expect to utilize up to $1 billion of available cash in 'twenty, 'twenty, two which will support our ambitious growth plans.

On the cash balance we ended the third quarter with almost $2 $4 billion in cash cash equivalents and current financial assets.

<unk> mobile launch clinical development of <unk> in more detail indications in organics 172 indications.

We continue to expect to utilize up to $1 billion of available cash in 'twenty, 'twenty, two which will support our ambitious growth plans.

<unk> is a global supply chain and the pipeline expansion through our immunology innovation program.

Specifically the rollout of our global launched clinical development of aircraft, taking more contained indications and organics 117 two indications.

You can find additional details behind these numbers in the press release, we issued this morning.

Investment in the global supply chain and the pipeline expansion through our immunology innovation program.

Now hand, the call to Keith for a commercial update thank you Carl Slide 15.

I'd like to start by saying that I'm really proud of our global team for their execution and accomplishments over the last year.

You can find additional details behind these numbers in the press release, we issued this morning.

We are now 10 months into our U S launch five months into our Japan launch and almost two months into our Germany launch.

Now hand, the call to Keith for a commercial update. Thank you Carl Slide 15, I'd like to start by saying that I'm really proud of our global team for their execution and accomplishments over the last year. We are now 10 months into our U S launch five months into our Japan launch and almost two.

Every day I see dedication to deliver on our mission to serve gmg patients who are suffering from this devastating disease.

We have now filed in Israel, Canada, and China. So 2023 will bring additional approvals that will expand our patient reach even further as Tim mentioned, our core strategies are working to engage our key stakeholders.

Months into our Germany launch.

Every day I see dedication to deliver on our mission to serve gmg patients who are suffering from this devastating disease.

Physicians and Payors slide.

Slide 16.

On the patient side, we saw more than 50% growth of gmg patients globally on therapy, which indicates we had another quarter of significant demand for <unk>. We believe we are setting a new standard and how gmg patients can manage their disease based on the efficacy and safety data.

Physicians and Payors slide 16.

On the patient side, we saw more than 50% growth of gmg patients globally on therapy, which indicates we had another quarter of significant demand for beef guard. We believe we are setting a new standard and how gmg patients can manage their disease based on the efficacy and safety data.

We have shown and adapt.

Most importantly, the data we saw in adapt are translating into the real world setting.

Approximately 50% of our patients are still coming from IV AIG, meaning that IV AIG is the most advanced therapy that they have experienced we will be watching closely over the next several quarters to see if we continue to see the shift into earlier treatment segments.

We have shown and adapt.

Importantly, the data we saw in adapt are translating into the real world setting.

We want to expand to reach those patients who have only experienced messaging on steroids are broad immunosuppressants. This will be an indicator of our long term trajectory on our path to reach 17000 addressable patients.

Our sales team has done a great job engaging a broad group of neurologist focused primarily on their top target physicians in the first quarters of launch we still face the effects of the pandemic. So the decision to hire an experienced sales force has been crucial to our early launch success.

Those patients who have only experienced messaging on steroids are broad immunosuppressants.

This will be an indicator of our long term trajectory on our path to reach 17000 addressable patients.

Our sales team has done a great job engaging a broad group of neurologists focus primarily on their top target physicians in the first quarters of launch we still face the effects of the pandemic. So the decision to hire an experienced sales force has been crucial to our early launch success.

By the end of the third quarter, we see continued breadth of prescribers. The most have still only really one or two scripts.

The opportunity ahead of US is to drive more experience with current prescribers and reach new potential customers that our field team have not yet engaged with.

By the end of the third quarter, we see continued breadth of prescribers. The most are still only written one or two scripts. The opportunity ahead of US is to drive more experienced with current prescribers and reach new potential customers that our field team have not yet engaged with.

Moving on to payers engaging with the payers prior to approval was a key driver on early uptake of <unk> and as a result patients have been able to successfully gain access.

At the start of the third quarter, we received a dedicated J code, which helped to shorten the time between script and infusion and improve the rate of patients going on therapy.

Moving on to payers engaging with the payers prior to approval with a key driver on early uptake of <unk> and as a result patients have been able to successfully gain access.

We will be taking a similar approach of the early engagement with payers ahead of the expected subcutaneous decision.

At the start of the third quarter, we received a dedicated J code, which helped to shorten the time between script and infusion and improve the rate of patients going on therapy.

Following our European approval in August we are also spending significant time with payers in this region, we launched in Germany and are able to sell through the <unk> process, while we negotiate price the value dossiers have also been submitted in key countries like France, Italy and the UK.

We will be taking a similar approach of the early engagement with payers ahead of the expected subcutaneous decision.

Following our European approval in August we are also spending significant time with payers in this region.

We would like to point out that the reimbursement process can take several years. So the growth trajectory in Europe is expected to be consistent but much more gradual than what we've seen in the U S and Japan.

We launched in Germany, and are able to sell through the <unk> process, while we negotiate price the value dossiers have also been stimulated in key countries like France, Italy and the UK.

Slide 17 patients and physicians have embraced the individualized treatment approach with good guard feeling that it aligns with the gmg experience. It is still too early to understand the distribution of treatment cycles on an annualized basis, but it seems to be aligning with what we saw in the adapt and adapt plus.

Slide 17 patients and physicians have embraced the individualized treatment approach, which we have guard feeling better aligns with the gmg experience. It is still too early to understand the distribution of treatment cycles on an annualized basis, but it seems to be aligning with what we saw in the adapt and adapt plus data.

Data base so far.

We believe the value of individualized treatment approach goes beyond dosing schedule and extends to delivery as well we are looking forward to the FDA decision on our subcutaneous BLA filing in the first half of next year, because it gives the opportunity to bring the patient more ways in which they can individually.

Base so far.

<unk> their treatment. It also gives us a second opportunity to show our commitment to the patient community by seeking approval and adult gmg patients regardless of antibody status slide.

Slide 18, before I turn the call back to Tim I want to once again commend our global team they have exemplified teamwork and dedication always putting the patient first as we advance on our mission.

Realize their treatment. It also gives us a second opportunity to show our commitment to the patient community by seeking approval and adult gmg patients regardless of antibody status slide.

We believe we have a truly transformative therapy would be a guard and we're motivated everyday by the stories, we hear from patients.

Slide 18, before I turn the call back to Jim I want to once again commend our global team they have exemplified teamwork and dedication always putting the patient first as we advance on our mission.

We know that the connections we are building now within our neuromuscular franchise will serve us well as we look ahead to our future launches.

We believe we have a truly transformative therapy would be a guard and we're motivated everyday by the stories, we hear from patients.

There are still many unknowns on the long term variables of our launch, but we are delivering where we can to generate demand and convert that demand into patients on therapy.

We know that the connections we are building now within our neuromuscular franchise will serve us well as we look ahead to our future launches.

Jim.

Thanks, Keith Slide 19.

There are still many unknowns on the long term variables of our launch, but we are delivering where we can to generate demand and convert that demand into patients on therapy.

In closing we are very happy to report another strong quarter of results.

We are energized by the early response to this stock and the engagement from our stakeholders.

Thanks, Keith Slide 19.

We are ready to drive forward in 2020 fleet with more global launch expansion on the approval decision on our subcutaneous product in Gmg and.

In closing we are very happy to report another strong quarter of results.

We are energized by the early response to desktop and engagement from our stakeholders.

And several key data readouts with our strategy and agenda for 2017.

We are ready to drive forward in 2023 with more global launch expansion and approval decision on our subcutaneous product in Gmg and several key data readouts with a package them up <unk> 17.

Auto immunity is ready for a resolution.

Patients.

Most all of our indications.

More options.

Especially options that may come with a fast onset of action a robust desktop response and few side effects.

Auto immunity is ready for a resolution.

Similar to what happened in the field of oncology, we are shifting towards precision interventions in autoimmunity and our Genesis part of this shift we believe that if we stick to our strategy of focusing on quality signs indications bring.

Across all of our indications.

More options.

Especially options that may come with a fast onset of action.

Robust desktop response and few side effects.

Bringing first in class immunology breakthroughs to the patients who need them, but we have a significant future value creation.

I would now like to open the call to your questions.

Greater.

At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad. We ask that you. Please limit yourself to one question and then rejoin the queue for further questions.

Bringing first in class immunology breakthroughs in the patients who need them, but we have a significant future value creation ahead.

I would now like to open the call to your questions.

Right.

Our first question comes from the line of Yaron Werber from Cowen Your line is open.

Great.

Thanks, so much for taking the question and congrats on a terrific quarter Tim.

Maybe just a quick sort of integrated question Carl.

Our first question comes from the line of Yaron Werber from Cowen Your line is open.

Carl can you give us a little bit of a sense on what the gross to net.

The impact is I know you typically give it every six months in your financials.

Great. Thanks, so much for taking the question and congrats on a terrific quarter Tim.

But is there any change from what we saw sort of in the first half and then secondly are you expecting typical seasonality sort of in Q1.

Maybe just a quick sort of integrated question Carl.

Carl can you give us a little bit of a sense on what the gross to net impact as I know you typically give it every six months in your financials.

I know it's obviously.

As an IV product, it's a buy and bill, but still is it going to be an imperfect. Thanks. So much.

But is there any change from what we saw sort of in the first half and then secondly are you expecting typical seasonality sort of in Q1.

Well. Thank you everyone and thank you for joining us today I'm going to hand, the first question in vitro Karl and then Keith I will ask you the question on possible seasonality right. So Carl.

I know it's obviously.

It's an IV product, it's a buy and bill, but still is there going to be an impact. Thanks. So much.

Thank you for your question. Indeed, we don't provide detailed financials in Q3, if you go back to the Q2 financials, which is on our website you will see that gross and net ease of added to note 12, 88%.

Thank you Don and thank you for joining us today I'm going to hand, the first question Indeed to Carl and then Keith I will ask you the question on possible seasonality right. So Carl.

Thank you for your question. Indeed, we don't provide detailed financials in Q3, if you go back to the Q2 financials, which is on our website you will see that gross to net is added to note 12, 88%.

And we don't have an update on that and also annuities and prevent to move materially. Thank you.

Alright, Thank all my second question.

On the second question about seasonality.

And we don't have an update on that and also annuities and prevent to move materially. Thank you.

I'll tell you one thing that we're learning during this launch is that.

<unk> is very promotional sensitive which means when there is times when our team is not in the sales out in the field or.

Alright, Thank all my second question.

Gives me on the second question about seasonality.

Or physicians and customers are not in their office, we could potentially see a lag. We also know that here in quarter four.

I'll tell you one thing that we're learning during this launch is that.

<unk> is very promotional sensitive which means when there is times when our team is not in the sales out in the field or physicians and customers are not in their office.

Around Thanksgiving and towards the end of the year. There are fewer days that infusion centers are open and you may have fewer patients making trips to their doctors. So we're expecting some seasonality. Thanks.

Could potentially see a lag we also know that here in quarter four around Thanksgiving and towards the end of the year. There are fewer days that infusion centers are open and you may have fewer patients making trips to their doctors. So we're expecting some seasonality. Thanks.

Your next question comes from the line of <unk> Ahmad from Bank of America Securities. Your line is open.

Hi, guys good afternoon to you.

Thanks for taking my question a real quick one here for your sub Q4.

Your next question comes from the line of <unk> Ahmad from Bank of America Securities. Your line is open.

Fifth card can you just remind us if theres any differences in how it's done.

Hi, guys good afternoon to you.

Relative to the IV formulation, specifically the regimen cycle answer Paul.

Thanks for taking my question around quick one here for your sub Q.

And to the extent that you can how are you thinking about pricing for that formulation versus the current the current formulation of <unk>. Thank you.

This card can you just remind us if theres any differences in how it's done.

Relative to the IV formulation, specifically the regimen the cycle answer Paul.

Thank you Tony and thank you for joining us today, although I will quickly handle these two questions. So think of the sub Q product presentation is being dosed in exactly the same way as we do for IV <unk>.

And to the extent that you can how are you thinking about pricing for that.

<unk> first is the current current formulation of IV. Thank you.

Remember, it's the explicit wishes patients to go to the individualized dosing and there for the <unk> product has been tested and will be marketed following the same individualized dosing as we did for Iot.

Thank you Tony and thank you for joining us today, although I will quickly handled these two questions. So think of the sub Q product presentation is being dosed in exactly the same way as we do for IV.

Our pricing point of view of the homework as to the full <unk>.

Remember, it's the explicit with patients to go through individualized dosing and there for the <unk> product has been tested and will be marketed following the same individualized dosing as we did for IP.

Process. So stay tuned we will communicate about the price in a similar way as it is for IP, when we get closer to the markets.

Thanks for the question.

Thanks, Tim.

From a pricing point of view of the whole mortgage did in full.

Your next question comes from the line of Ya Qin <unk> from Guggenheim Partners. Your line is open.

Process. So stay tuned we will communicate about the price in a similar way as it did for IP, when we get closer to the markets.

Scott.

Thank you very much a couple of questions for me.

Mostly on the CIB piece Ryan could you just comment on how you are handling the particular use in the study that's plus spot.

Thanks for the question.

Thanks, Tim.

Your next question comes from the line of <unk> from Guggenheim Partners. Your line is open.

Also talk about the historical relapse rate that we shouldnt be thinking about I think when we look at the literature. It some.

Thank you very much a couple of questions for me.

On the CIB piece, Ryan could you just comment on how you are handling the stickney argues in the study.

On $45, 50% again looking at 88 events.

That would translate to what would you like to show.

Thus far can you also talk about being a historical relapse rate that we shouldnt be thinking about I think when we look at the literature, it's somewhere around $45, 50%, then youre looking at 88 events by.

Once the data on all of that what sort of efficacy profile you are shooting for.

Thank you.

Thank you your ethane so.

The way the CDP trial has been designed as such debt.

<unk> made two and what would you like to show once the data are out what sort of efficacy profile. Thank you.

After we confirm or validate youll see IDP diagnosis, we will basically takeaway of current litigation and see a worse and to a certain degree on any of these scales.

Thank you your ethane so.

The way the CDP trial has been designed as such debt.

And then we will try to restore what youll often does a function with a coverage of multimodal therapy. So thats. How you have to think about how we deal with steroids. They will basically be taken away from the patients remember thats the enroll naive patients so the year to diagnose.

After we confirm or validates youll see ADP diagnosis, we will basically take away your current litigation and see a worse and to a certain degree on any of these scales.

And then we will try to restore what you lost in terms of function with <unk> monotherapy. So that's how you have to think about how we deal with steroids. They will basically be taken away from the patients remember thats the enroll naive patients with <unk>.

Those steroids or.

For patients on <unk>, So we do it with both steroid Niv AG patients.

Newly diagnosed patients of course, we will not have to go through that first step.

Then on expectations around response rates.

<unk>.

<unk> steroids.

<unk> study, which we typically compared in reference to would be the ice trial, where you're roughly sold 50% of this full faith all IV AIG.

For patients on <unk>. So we do it with both steroid Niv AG patients newly diagnosed patients of course will not have to go through that first step.

And then on expectations around response rates.

Nothing to say on relapse rate.

The <unk> study, which we typically compared in reference to would be the ice trial, where you're roughly sold 50% of this bullshit all IV AIG.

Yes.

It's too early to comment from that point of view. Thanks.

Thanks for the question, we can move to the next.

Your next question comes from the line of Matt <unk> from Deutsche Bank. Your line is open.

Nothing to say all relapse rate.

Hi, Thank you for taking the question.

Yes.

It's too early to comment from that point of view. Thanks.

So just wanted to ask if you could give us an update on the duration of treatment and the average number of cycles that you've seen so far since launch in the real world.

Thanks for the question, we can move to the next.

Your next question comes from the line of <unk> <unk> from Deutsche Bank. Your line is open.

As well as <unk>.

Hi, Thank you for taking the question.

How should we think about Germany, and Japan around sorry.

Just wanted to ask if you could give us an update on the duration of treatment and the average number of cycles that you are seeing so far since launch in the real world.

The U S.

Graham uptake.

Finally, if you could comment on the impact of the J code launch in July .

As well as <unk>.

How should we think about Germany and Japan.

And how should we think about its impact basically thank you.

First the U S.

Thanks for the question and maybe Keith you want to talk about how you see the distribution of the cycle used emerge into real growth compared to the <unk> study and then maybe also briefly comment on how the Germany and Japan ramp is growing our vehicles. We can be very brief this is mainly facilitating.

Ram uptake.

Finally, if you could comment on the impact of the J code launch in July .

And how should we think about its impact basically thank you.

Thanks for the question and maybe Keith you want to talk about how we see the distribution of the cycle use emerge in the real world compared to the that study and then maybe also briefly comment on how the Germany, and Japan, Brian Thats going on vehicles, we can be very brief this is mainly facilitating.

Turnaround time between enrollment and a drug administration, but key go ahead on the first two questions. Please.

Sure happy to do so Tim So first of all on the duration of treatment in the real world.

We're seeing is very consistent with what we've seen in the adapt study I can tell you that we're getting to a point where more patients and physicians are getting very comfortable with the individualized dosing because I think one of the key things about the individualized dosing is that once each individual patient has established.

Around time between enrollment and a drug administration, but key go ahead on the first two questions. Please.

Sure happy to do so Tim So first of all on the duration of treatment in the real World. What we're seeing is very consistent with what we've seen in the adapt study I can tell you that we're getting to a point where more patients and physicians are getting very comfortable with the individualized dosing because I think one of the key things about the.

That interval between cycle, one and cycle too and then between cycle, two and cycle III, it stabilizes and that becomes that becomes their own individual cadence. It makes it very easy to project when they'll need their next cycle and very easy to schedule their time in the infusion share.

Individualized dosing is that once each individual patient has established that interval between cycle, one and cycle too and then between cycled through and cycled III it stabilizes and that becomes that becomes their own individual cadence. It makes it very easy to project when they'll need their next cycle and very.

Now its still too early to give annual projections, but I would say that we're on target for what we've seen in the adapt study and the adapt plus study on the typical patient requiring.

Easy to schedule their time in the infusion share right now its still too early to give annual projections, but I would say that we're on target for what we've seen in the adapt study and the adapt plus study.

Five cycles per year.

As far as the Japan launch and the Germany launch in Japan, you know we have the broadest label on the Globe, where we include zero negatives I'm really pleased to share that we're adding not only seronegative patients, but also acetyl choline receptor positive patients.

On the typical patient requiring roughly five cycles per year.

As far as the Japan launch and the Germany launch in Japan, you know we have the broadest label on the Globe, where we include zero negatives I'm really pleased to share that we are adding not only seronegative patients, but also acetyl choline receptor positive patients we have consistent growth in that marketplace through our first two quarters.

Have consistent growth in that marketplace through our first two quarters.

And so we believe that the Japan pace of adding patients will continue to remain consistent Germany, we're barely two months into the launch.

We're off to a nice start but as you know we're negotiating reimbursement.

Yeah.

And so we believe that the Japan pace of adding patients will continue to remain consistent Germany, we're barely two months into the launch.

What I can say having spent a few weeks in Germany last month is that the unmet medical need for gmg patients in Germany is no different than we see other places on the globe. They havent had new therapies available to them in decades.

We're off to a nice start but as you know we're negotiating reimbursement.

I can say having spent a few weeks in Germany last month is that the unmet medical need for gmg patients in Germany is no different than we see other places on the globe. They havent had new therapies available to them in decades, and they are really looking for a new option in their treatment.

And they're really looking for a new option in their treatment.

Your next question comes from the line of Derek Akela from Wells Fargo. Your line is open.

Hey, good morning, Thanks for taking the question and congrats on the progress during the quarter. So just two quick ones from US I guess one of your future competitors kind of commented on <unk> potential indications like RA that might not solely be auto body and auto antibody driven so just kind of curious have you done any preclinical work there and just your thought.

Your next question comes from the line of Derek <unk> from Wells Fargo. Your line is open.

Hey, good morning, Thanks for taking the question and congrats on the progress during the quarter. So just two quick ones from US I guess one of your future competitors kind of commented on <unk> potential in indications like RA that might not solely be auto body and auto antibody driven so just kind of curious have you done any preclinical work there and just your thoughts.

On pursuing those types of indications and then also is it fair to think that a good benchmark for the pace of enrollment for both the valor trial and our.

Our <unk> trial.

Would it be similar to <unk>.

On pursuing those types of indications and then also is it fair to think that a good benchmark for the pace of enrollment for both the valor trial and our Alt.

Thanks, Eric Thanks for being with us today.

On enrollment speed is very difficult to triangulate from.

Current or past trials I would say that each channel has its own dynamics and enrolling a global trial in rare diseases is always hard work as we know so stay tune that it could be going to update you on a regular basis on how enrollment will be going on the topic of rheumatoid arthritis, Andre we have not.

<unk> trial.

Would it be similar to the IDP. Thanks.

Thanks, Eric Thanks for being with us today.

On enrollment speed is very difficult to triangulate from.

In the past trials I would say that each trial has its own dynamics and enrolling a global trial innovate diseases is all his hard work as we know so stay tuned directly going to update you on a regular basis on how enrollment will be growing on the topic of rheumatoid arthritis, Andre we are not <unk>.

Excluding that subsets of patients actually we'd see an active role of auto antibodies. It just that the biology is less created less linear than will be like to see for the indications to be prioritized. So we always start from a solid biologic rationale and then we take it from there. So this is other priority indication.

<unk> that subset of patients actually would see inactive roll off auto antibodies. It just that the biology is less clear is less linear than will be like to see for the indications to be prioritized. So we always start from a solid biology rationale and then we take it from there so.

So far for us thank you.

Your next question comes from the line of Alex Thomson from Stifel. Your line is open.

Hey, Thanks for taking my question.

On <unk> I was wondering if you could comment on your confidence in obtaining a broad label given that youre new evidence here is from the IV formulation and sort of how the FDA might view that and then assuming you do get a print and our enterprise label, how much larger do you view the addressable population.

This is not a priority indication so far for us. Thank you.

Your next question comes from the line of Alex Thomson from Stifel. Your line is open.

Hey, Thanks for taking my question on <unk> I was wondering if you could comment on your confidence in obtaining a broad label given that youre new evidence here is from the IV formulation and sort of how the FDA might view that and then assuming you do get a print and our enterprise label, how much larger do you view the addressable population.

Thanks, Alex. Thank you for this question. So you do know that we have a longstanding commitment to the Mg patient population. So we do have evidence that <unk> may work in these seronegative patients.

We saw that not only in the open label extension study of <unk> plus.

Thanks, Alex. Thank you for this question. So you do know that we have a long standing commitment to the Mg patient population. So we do have evidence that <unk> may work in these seronegative patients.

But we also saw that in the <unk> study. So these data have been submitted.

And we are indeed going for a broad label the outcome of that interaction with the <unk>.

We saw that not only in the open label extension study plus but we also saw that in the <unk> study. So these data have been submitted and we are indeed going for a broad label the outcome of that interaction.

Regulated of course.

We will have to be seen so let's leave that as a review issue, but it doesn't diminish our long term.

Our commitment to the Mg patient population. Thank you.

Your next question comes from the line of Matthew Harrison from Morgan Stanley . Your line is open.

And a regulator of course.

Have to be seen so let's leave that as a review issue.

But it doesn't diminish our long term.

Great.

Afternoon. Thanks for thanks for taking the question.

Amendment to the Mg patient population. Thank you.

I guess.

I guess two things I wanted to ask about.

Your next question comes from the line of Matthew Harrison from Morgan Stanley . Your line is open.

The first is.

Just a follow up to the prior question.

Around some of the larger indications, where the biology is less clear.

Great.

Thanks for thanks for taking the question.

How do you think strategically about that obviously the strength of the businesses is improving.

I guess.

Two things I wanted to ask about.

The first is just.

And sort of your position in terms of ability to see sort of the runway where revenue could be is improving how do you think about potentially.

Just a follow up to the prior question.

Around some of the larger indications, where the biology is less clear and just how do you think strategically about that obviously the strength of the businesses is improving.

Taking some more risk in terms of some of the potentially larger indications and then secondly, just a question on.

And sort of your position in terms of ability to see sort of the runway where revenue could be improving do you think about potentially.

On phasing.

I know people have asked about Japan, and Germany, just maybe more broadly as we think about some of the other countries that could come online next year any anything we should be thinking about specifically about both countries in terms of payback.

Taking some more risk in terms of some of these potentially larger indications and then secondly, just a question on.

On phasing.

Thank you Matthew and I will hand over the question on global expansion to Keith in a minute.

On the larger indications Metro of course, we would be looking at some of them.

I think we're pretty explicit about what our next priority will be in terms of the 10 indications. We are targeting remember that we stated the aspiration to be a 15 indications.

Thank you Matthew and I will hand over the question on global expansion to Keith in a minute.

The larger indications Metro of course, we are looking at some of them.

2025.

I think <unk> to do that but for the moment, we are not going to compromise on the biologic rationale for these indications. So we can always start from biology.

I think we were pretty explicit about what our next priority will be in terms of the 10 indications with targeting remember that we stated the aspiration to be in 15 indications by 2025.

The latest with clinical feasibility and then finally look also at commercial opportunity, we like commercial space, where the unmet medical need is very high and ready to actually have an ability to influence at the treatment paradigm similar to what we have seen for some of the indications where we already play.

Well on track to do that but for the moment, we are not going to compromise on the biology rationale for these indications. So we will always start from biology, then overlaid with political feasibility and then finally look also at commercial opportunity.

And maybe Keith you want to address the second question on global expansion, we can expect next year.

Like commercial space, where the unmet medical need is very high and where do you actually have an ability to influence at the treatment paradigm similar to what we have seen some of the indications where we already play in.

Sure happy to do so Tim So Matthew as you know we have the European regulatory approval, but we actually only promote in one country in Europe , right now and Thats, Germany.

Maybe Keith you want to address the second question on global expansion look we expect next year.

And the other countries. We are have submitted dossier. So that we can get reimbursement and then began to promote so I call out particular to view, France, Italy, the U K, where we will continue to make progress, but that's just the beginning so when you think about phasing thinking about our desire to be able to.

Sure happy to do so Tim So Matthew as you know we have the European regulatory approval, but we actually only promote in one country in Europe , right, now and Thats, Germany and.

And the other countries. We are have submitted dossier. So that we can get reimbursement and began to promote so I call out particular to you, France, Italy, the U K, where we will continue to make progress, but that's just the beginning so when you think about phasing think about our desire to be able to.

Serve patients across the European Union.

Secondly, we mentioned Israel.

Canada, and China, where we've already filed so I think you can expect to see us to begin to commercialize in those countries in 2023 and I think next year, we will give further clarity on some of our expansion plans to other parts of the globe. So we can maximize our ability to serve patients.

Serve patients across the European Union.

Secondly, we mentioned Israel.

Canada, and China, where we've already filed so I think you can expect to see us to begin to commercialize in those countries in 2023 and I think next year, we'll give further clarity on some of our expansion plans to other parts of the globe. So we can maximize our ability to serve patients.

Your next question comes from the line of Danielle Brill from Raymond James Your line is open.

Hey, guys good morning.

You guys on the court and thanks for the question.

I'm curious, how we should be thinking about the cadence of new patient adds moving forward and then.

Your next question comes from the line of Danielle Brill from Raymond James Your line is open.

Looking ahead to slide.

<unk> availability, what impact that might have on broadening use are there any early indications that docs are waiting for the subset of prescribing more broadly. Thank you.

Hey, guys good morning.

Thats a record for the question.

I'm curious, how we should be thinking about the cadence of new patient adds moving forward and then.

Thank you Danielle and thank you for joining us on the call today, Keith would you mind, taking these two questions. Please.

Our head to the F secure availability what impact that might have on <unk> are there any early indications that docs are waiting for the subset of prescribing more broadly. Thank you.

Yes happy to do so so danielle as far as new patient adds.

We gave some some clarity here that we passed the 2000 patient mark during quarter, three and we've seen over 50% growth in.

Thank you Danielle and thank you for joining us on the call today, Keith would you mind, taking these two questions. Please.

In quarter over quarter, two in our patient adds but I think the real question is what's the trajectory going to continue with the launch.

Yes happy to do so so danielle as far as new patient adds I think we gave some some clarity here that we passed the 2000 patient mark during quarter, three and we've seen over 50% growth in quarter over quarter two in our patient adds but I think the real question is what's the trajectory going to.

All all of our demand indicators continue to show consistent growth, but you have to remember that right now there's so many of our patients almost 50% are coming from their most recent therapy being <unk>, if we don't change that.

With the launch.

All all of our demand indicators continue to show consistent growth, but you have to remember that right now the <unk>.

Our main pond that we fish in that pond will begin to dry up so our long term trajectory is going to depend on our ability to shift into earlier lines of treatment of patients that have only experienced oral therapies and be the first infusible therapy.

Many of our patients almost 50% are coming from their most recent therapy being IV AG. If we don't change that as our main pond that we fish in that pond will begin to dry up so our long term trajectory is going to depend on our ability to shift into earlier lines of treatment of patients that have only experienced oral therapy.

That is utilized.

As far as subcutaneous and pent up demand and the market research that we've done with physicians and with patients. This is providing optionality. So it's providing options to patients is providing it to the health care professionals, but also to payers I think we will see our sub Q uptake a major part of it.

And be the first infusible therapy that is utilized.

We'll be reimbursement and the fact that <unk> will go into part D versus our IV that goes in part B and what's associated with with out of pocket expense.

The bottom line as a company, we are agnostic as to which formulation a patient or a health care provider or a payer selects we want to make sure that we can serve as many patients as possible and thats why its going to be beneficial to add this to our to our bag.

B reimbursement and the fact that sub Q will go into part D versus our IV that goes in part B and what's associated with with out of pocket expense.

Thank you.

Your next question comes from the line of a cash tomorrow from Jefferies. Your line is open.

Hey, guys.

So a couple how comfortable are you with the perception that <unk> could have <unk> like efficacy to ADP.

Your next question comes from the line of cash Tomorrow from Jefferies. Your line is open.

<unk> seen UCB pale in this indication with a different trial design and then even your team kind of.

Hey, guys.

Baked in a go or no go interim.

A couple how comfortable are you with the perception that <unk> could have <unk> like efficacy in ADP we've.

So are you comfortable with that base case expectation is it possible that the bucket actually differentiate from IV AIG on from a response rate perspective.

We've seen UCB pale in this indication with a different trial design and then even your team kind of bit baked in a go or no go interim.

Additionally, on the Gmg launch it looks like new patient starts did start to slow down to kind of 600.

So are you comfortable with that base case expectation is it possible that the bucket actually differentiate from IV AIG on from a response rate perspective.

Is that kind of.

A fair assumption on a go forward new patient add.

In the U S.

Additionally, on the Gmg launch it looks like new patient starts did start to slow down to kind of 600.

For next year or could that start to pick up once the <unk> opportunity comes in line and what have you seen in terms of your persistence rates. So far so basically patients who started on drug in Q1 what percent of those patients are still on drug.

Is that kind of.

A fair assumption on a go forward new patient add.

In the U S.

Thank you.

Thank you Akash, although it gives you a question to entry to keep talking about how.

We look at patient adds going forward and discontinuation.

On C IDP.

Thank you.

We have always been very transparent about why we think this is an <unk> mediated disease.

Thank you Rakesh I will give you a question to entry to keep talking about.

Right.

How we look at patient adds going forwards and discontinuation.

Confidence.

Conviction from the immune absorption data the plasma exchange data and to a certain extent the ibs data I think we also went through great lengths to explain what typical risks or pitfalls are associated with the running of clinical trials and said it would be it's very tricky and I think we have a rational approach to derisking to study.

On CDP.

We have always been very transparent about why we think this is an <unk> mediated disease.

Right.

Confidence.

Conviction from the immune absorption data the plasma exchange data and to a certain extent the ibs data I think we also went at great lengths to explain what typical risks or pitfalls are associated with the running of clinical trials in Seattle is very tricky and I think we have a rational approach to the listing to study.

This being said as to the clinical experiments I mean, if it would be 100% sure. We would look to do the experiment. So I think it's reasonably derisked from a trial design point of view this conviction in biology, but let's do the experiment first though and then talk about outcomes and Keith do you want to take the two remaining <unk>.

This being said, it's still a clinical experiments I mean, if it would be 100% sure we would not need to do the experiment. So I think it's reasonably derisked from a trial design point of view this conviction in biology, but let's do the experiment first though and then talk about outcomes and Keith do you want to take the two remaining <unk>.

<unk> please.

Sure happy to do so so when it comes to new patient adds.

All I can say is that our indicators for demand continue to show consistent growth. So.

So we continue to get new patients that are interested in being on Bip guard in new scripts coming in we're not going to give projections on the trajectory as we're just three quarters into this.

<unk> please.

Sure happy to do so so when it comes to new patient adds.

All I can say is that our indicators for demand continue to show consistent growth.

But overall as I mentioned before we are going to need to expand into the earlier treatment lines I can say directionally, we've been headed that way with more patients with <unk> being the first infusible therapy that they work, but still the majority of our patients are coming from <unk>.

So we continue to get new patients that are interested in being on Bip guard in new scripts coming in.

Not going to give projections on the trajectory as we're just three quarters into this.

But overall as I mentioned before we are going to need to expand into the earlier treatment lines I can say directionally, we have been headed that way with more patients with <unk> being the first infusible therapy that they work, but still the majority of our patients are coming from IV AIG.

Second in regard to discontinuation.

We have seen some discontinuation, so thats really not a surprise.

As you know between cycle wanting cycle to bid GARP works and roughly 80% of patients that are exposed to the product. So we would expect to see a discontinuation rate.

Second in regard to discontinuation of <unk>, we have seen some discontinuation thats really not a surprise as you know between cycle, one and cycle to bid GARP works and roughly 80% of patients that are exposed to the product. So we would expect to see a discontinuation rate we're.

We're not at that level at this point, that's not really that big of a surprise either considering that the majority of patients that are on Pip guard started on therapy in quarter, two and quarter three so.

So overall no exact projections on discontinuation rates.

We expect that we will continue to see some overtime.

Your next question comes from the line of Joel Beatty from Baird. Your line is open.

So overall no exact projections on discontinuation rates.

Hi, Thanks for taking the question.

I understand.

We expect that we will continue to see some overtime.

50% of the patients are coming from off of IV, but looking at it from a different way.

Your next question comes from the line of Joel Beatty from Baird. Your line is open.

Percent of patients on IV IAG.

Are kind of starting on <unk>, how does that compare with what percent of earlier line patients are starting on.

Hi, Thanks for taking the question.

I understand.

50% of the patients are coming from off of <unk>, but looking at it from a different way what percent of patients on IV IAG are kind of starting on FERC decision that and how does that compare with what percent of earlier line patients are starting on okay.

Okay.

Thank you joelle for discretion.

To address this question on what we think the percentage of patients on IV.

That is effectively starting in <unk>.

Yeah, I mean, Joel the breakdown that we've given is what we've already shared which is almost 50% the last or the most extensive therapy that they were on is <unk> that doesn't mean that they switched directly from it. It means that was as far as they've gone and they're in their overall treatment paradigm.

Thank you joelle for discretion.

To address this question on what we think the percentage of patients on <unk>.

That is effectively starting on that Doug.

Before they switch over to <unk> I don't have the exact data on who was actually being infused IV AIG and switch directly to <unk> versus <unk>.

I used <unk> three months ago and switched over to <unk>.

Before they switch over to <unk>.

Your next question comes from the line of Douglas Tsao from H C. Wainwright. Your line is open.

Have the exact data on who was actually being infused IV AIG and switch directly to <unk> versus <unk>.

Hi, good morning, Thanks for taking the questions.

They used <unk> three months ago and switched over to <unk>.

Maybe when we think about the launching sub Q next year just curious.

Your next question comes from the line of Douglas Tsao from H C. Wainwright. Your line is open.

Have you already started to engage with payers and obviously with the IV.

The pace of getting coverage was really impressive do you expect to see a similar percentage of patients.

Hi, good morning, Thanks for taking the questions.

Maybe when we think about the launching sub Q next year just curious.

<unk> at the time of launch and what dynamics should we think about I think you touched on it. This is going to be part D versus part D that we should consider in terms of the pace of the launch. Thank you.

Have you already started to engage with payers and obviously with the IV.

The pace of getting coverage was really impressive do you expect to see a similar percentage of patients.

Thank you Douglas I think we can be brief on this question. It's too early for us to come in and you have seen our modus operandi for IV <unk>.

We'd like to reach out proactively to Vegas and be transparent about the value, we think that the table and how do we think about pricing and calibrate that pricing. So expect this company to continue to execute along these lines.

Thank you Douglas I think we can be breed on this question. It's too early for US to comment you have seen our modus operandi for IV <unk>.

We will comment on it when we get closer to launch okay. Thanks for the question Okay.

We'd like to reach out proactively to Vegas and be transparent about the value, we think that the table and how do we think about pricing and calibrate that pricing point. So expect this company to continue to execute along these lines, but we will comment on it when we get closer to launch okay. Thanks for the question Okay.

Okay.

Your next question comes from the line of Allison <unk> from Piper Sandler Your line is open.

Hi, good morning, Thanks for taking the question.

Just another on the <unk> launch I know you said the U S patient mix by severity has stayed relatively constant.

Your next question comes from the line of Allison <unk> from Piper Sandler Your line is open.

Since launch about half of patients from IV AG, but just thinking about the other 50% of patients I guess wondering if you could talk to whether you've seen any impact or slowdown in patient switching from soliris to <unk>.

Hi, good morning, Thanks for taking the question.

Just another on the Olive Garden launch I know you said the U S patient mix by severity has stayed relatively constant.

Now that we're a few months into the <unk> launch.

And just any is there any discernible impact to Matt too.

<unk> demand.

That you would call out thanks.

Allison Thanks for being with US today, Thanks for joining and thank you for your question Keith do you want to Colombia over 50 percentage of <unk> experienced and the dynamics there. Please.

Now that we're a few months into the <unk> launch.

Just any is there any discernible impact to demand.

Yes happy to do so so Allison the other 50% is going to come from anywhere across the treatment paradigm. So they can come from patients that have only experienced messaging on some that have had messaging on steroids, others that have had broad immunosuppressants.

That you would call out thanks.

Allison Thanks for being with US today, Thanks for joining and thank you for your question Keith do you want to comment on the other 50 percentage of non IV has experienced and the dynamics there. Please.

Yes happy to do so so Allison the other 50% is going to come from anywhere across the treatment paradigm. So they can come from patients that have only experienced messaging on some that have had <unk> and steroids others that have had broad immunosuppressants also and that other 50%. We do see patients who is most advanced therapy.

So and that other 50%, we do see patients who is most advanced therapy happened to have been rituximab.

<unk> label Rituximab, and we do have some patients from seat that have been on previously been on <unk>.

Quite frankly, we don't really focus on the five refractory patients or rituximab refractory patients because we think our real competition. In this space is steroids and brought immunosuppressant therapies. That's how we get to that 17000 total addressable market and Thats really where our field team folk.

<unk> been rituximab.

Off label Rituximab, and we do have some patients from seat that have been on previously been on <unk>.

Quite frankly, we don't really focus on the five refractory patients or rituximab refractory patients because we think our real competition in this space is steroids and broad immunosuppressant therapies. That's how we get to that 17000 total addressable market and Thats really where our field team focus.

This is on but we do get some of those biologic refractory patients in our starts each quarter.

Your next question comes from the line of Joon Lee from <unk> Securities. Your line is open.

Is on but we do get some of those biologic refractory patients in our starts each quarter.

Hey, Thanks for taking our questions I think one of your <unk> competitor MGMT has.

Bit of a more modest expectations for the addressable GMT patient market.

Your next question comes from the line of Joon Lee from <unk> Securities. Your line is open.

Maybe less than half of what you think you can address with gift card can you elaborate on the differences and how you.

Hey, Thanks for taking our questions I think one of your <unk> competitor and PMT has.

To get there. Thank you.

Bit of a more modest expectation for the addressable GMT patient market.

Thanks for the question and thanks for being with Us.

Up to us I think to comment on the homework of one of the competitors.

Maybe less than half of what you think you can address with Zipcard can you elaborate on the differences and how you.

Colleagues, who is going to help us to build out this space into what it could be I think we have been very transparent into how we did at the total addressable market population I think our analysis.

To get there. Thank you.

Thanks for the question and thanks for being with Us.

Not up to us I think to comment on the homework of one of the competitors.

Usable it starts from a total patient population is it.

Published into finished publication in 2001, which we think is one of the most credible sources and then B, we look down into how many of those of gmg, how many of those that we think our local knowledge and with currently used therapeutics.

Usable it starts from a total patient population is a plus.

Published in the finished application in 2001, which we think is one of the most credible sources and then we look down into how many of those of gmg, how many of those that we think our local knowledge and with currently used therapeutics and then we apply reasonable penetration.

Then we apply a reasonable penetration.

Of the patients.

So.

I think we can talk about how we do our analysis to talk to the 17000.

And we feel comfortable with the assumptions, we have been making so far thank you.

Your next question comes from the line of Nick <unk> from Goldman Sachs. Your line is open.

Of the patients groups so I.

I think we can talk about how we do our analysis to come to the 17th.

Hi, there, it's Nick here on Fem care.

As we feel comfortable with the assumptions, we have been making so far thank you.

Just a couple of questions coming back to the sub.

Okay.

As you experienced a VIP launch in Mg changed your expectations around the long term IV mix. There and then is there anything we should be thinking about.

Your next question comes from the line of Nick <unk> from Goldman Sachs. Your line is open.

Hi, there, it's Nick here on Fem care.

Vacation specific that you see driving a meaningful variation across the different indications.

Just a couple of questions coming back to the sub.

Okay.

As you experienced a VIP launch in Mg changed your expectations around the long term IV mix. There and then is there anything we should be thinking about.

Thank you.

Thank you Nick Thanks for joining us in general we always said Nick that for each indication we have the ambition to be both on the market serving patients with the IV and there's a few products that presentation, maybe Keith do you want to share any high level comments, we have concerning the long term mixed between IC and <unk> Q.

Indication specific that you see driving a meaningful variation across the different indications.

Thank you.

Thank you Nick Thanks for joining us in general will be always suddenly debt for each indication we have the ambition to be both on the market serving patients with the <unk> products that presentation, maybe Keith do you want to share any high level comments, we have concerning the long term mix between IP and sub Q.

Yes, Nick I think honestly the mix between IB and sub Q Youll, probably see more dramatic from a geographical point of view then you will see from an indication point of view I.

I think when it comes to potentially Europe , and Japan, you can see sub Q step in and began to take over.

Yes, Nick I think honestly the mix between IB and sub Q Youll, probably see more dramatic from a geographical point of view then you will see from an indication point of view I.

The marketplace as far as <unk>, but still offering both formulations across the globe and the U S. I think there's going to be a lot of considerations that will not only be patient driven in healthcare professional driven but I also think there will be a payer driven aspect in particular when it comes to the Medicare population.

I think when it comes to potentially Europe , and Japan, you can see sub to step in and began to take over.

That could very much affect the mix regardless of indication within the U S geographic geography.

Your next question comes from the line of Thomas Smith from <unk> Securities. Your line is open.

That could very much affect the mix regardless of indication within the U S geographic geography.

Hey, guys. Good afternoon, thanks for taking our questions and let me add my congrats on the strong launch just on this.

Your next question comes from the line of Thomas Smith from <unk> Securities. Your line is open.

Please go ahead prescribing patterns can you talk a little bit about the.

Split between disk art use an uptake in the community versus academic centers are you are.

Hey, guys. Good afternoon, thanks for taking our questions and let me add my congrats on the strong launch just on.

Are you seeing any noticeable differences in prescribing patterns between these two settings and how has that evolved over the last few months.

Please go ahead prescribing patterns can you talk a little bit about the split between just use an uptake in the community versus academic centers are you.

Okay.

Thank you Tomas. Thank you for this question Keith do you want to comment on this split between community versus academic.

Are you seeing any noticeable differences in prescribing patterns between these two settings and how has that evolved over the last few months.

Yes happy to.

Thomas we actually haven't given the breakdown of community versus academic we have made it clear that we have patients coming.

Thank you Thomas Thank you for this question Keith do you want to comment on the split between community versus academic.

Both of these settings.

What's really key to remember here is that.

Yes happy to.

70% of prescribers that have utilized <unk> still have only written them one or two scripts. So regardless if they are in the community or academic thats. The overall population that is our opportunity for growth.

So Thomas we actually haven't given a breakdown of community versus academic we have made it clear that we have patients coming from both of these settings I think what's really key to remember here is that of the 70% of prescribers that have utilized <unk> still have only written them one or two scripts so rig.

The other aspect is the additional reach of physicians that we need to get to.

So the pandemic still plays into this sometimes academic centers are much more difficult to get into so we still need to increase our reach to potential prescribers.

Garden less if they are in the community or academic thats. The overall population that is our opportunity for growth.

The other aspect is the additional reach of physicians that we need to get to.

Got it thanks guys.

So the pandemic scale plays into this sometimes academic centers are much more difficult to get into so we still need to increase our reach to potential prescribers.

Your next question comes from the line of Emily Field from Barclays. Your line is open.

Okay.

Hi, Thanks for taking my question just a couple of quick ones.

I was just wondering and IDP is this continuous dose of epcot share amount the same evidence and myasthenia gravis I was just kind of asking Matt.

Got it thanks guys.

Your next question comes from the line of Emily Field from Barclays. Your line is open.

Thinking about how the number of injections on an annual basis could impact annual pricing per bank per patient in the U S.

Okay.

Alright, Thanks for taking my questions a couple of quick ones.

I'm just wondering.

Is this continuous dose of Etgar chairman aren't the same as it is in my opinion gravis I was just kind of asking Matt.

And then secondly.

Jeff.

I wanted to ask about your confidence in sort of comparing <unk> response rates and see IDP.

Thinking about how the number of injections on an annual basis impact annual pricing per patient in the U S.

It's part of what's underlying thinking that the IDE study is that the comparator that.

As part of their trial design for ice they also get require patients to have.

And then secondly.

Jeff.

I wanted to ask about your confidence in sort of comparing IV response rate with GDP.

Deterioration going into the study, whereas the other FBR on competitor.

It's part of what's underlying the ice study the comparator that.

And their trial that didn't show efficacy noted that perhaps that result was driven by a skewing a stable <unk> patients in the study.

As part of their trial design for ice. They also did require patients to have.

Deterioration going into the study, whereas the other FBR on competitor.

Yes.

Thank you Emily.

And their trial it Didnt show efficacy noted that perhaps that result was driven by a skewing of stable <unk> patients in the study. Thank you.

I will leave the question on dosing frequency and potentially impacting pricing with key for <unk>, but it's going to be a high level answer only I mean, we need to wait for data.

Turning to IV <unk> versus <unk> got particular, despondency IDP, but your guess is good as mine.

Thank you Emily.

I will leave the question on dosing frequency and potential impact on pricing with Keith for CDP, but it's going to be a high level answer only I mean, we need to wait for data.

I think it's a fifth calibration point, the 50% of the ice.

While response rate. It also helps us to calibrate what we think we need in order to effectively compete.

Setting the IV <unk> versus being able to respond and see IDP well youll get as good as mine.

We have not seen the detailed data from UCB and see IDP, but my mind was initially going first to the fact that did not do an independent verification of the diagnosis and we know and we actually made both of them.

I think it's a fifth calibration point, the 50% of the ice.

Trial response rate.

It also helps us to calibrate to know what we think we need in order to effectively compete.

We have not seen the detailed data from UCB in CIP, but my mind was initially going first to the fact that did not do an independent verification of the diagnosis.

We noted about 50% of CDP patients turned out not to be too see ADP patients. So without such an independent adjudication Committee you just won't be what patients have been tested in this small phase II trial, let's leave it there for today and maybe Keith is that any high level comments, you would like to give.

No.

<unk> made both of them and we noted above 50% of <unk> patients turned out not to be true CDP patients so without such an independent adjudication Committee.

Concerning pricing in an indication like see IDP.

Yes, Emily I mean first of all the sub Q as a flat dose. It's 1000 milligram flat dose we get that is non inferior to 10 milligram per kilogram IV. So it is going to be the same 1000 milligrams flat dose for Mg as it is as it is and see IDP.

Just wondering what patients have been tested in this small phase II trial.

Let's leave it there for today and Medicaid is that any high level comments, you would like to give concerning pricing in an indication like CDP.

Yes, Emily I mean first of all the sub Q as a flat dose. It's 1000 milligram flat dose we get that is non inferior to 10 milligram per kilogram IV. So it is going to be the same debt 1000 milligrams flat dose for Mg as it is as it is in CIP as.

You know from the <unk> study design, which was shown in the slides, we do dose that continuous and much more frequent in the primary part of that study, let us get the final results from that as well as look at the data from the open label extension and then I think we'll be able to provide more clarity around dosing and where that could lead for pricing implications.

As you know from the <unk> study design, which was shown in the slides, we do dose that continuous and much more frequent in the primary part of that study, let us get the final results from that as well as look at the data from the open label extension and then I think we'll be able to provide more clarity around dosing and where that could lead for pricing implications.

And your next question comes from the line of Trevor All read from Oppenheimer. Your line is open.

Yeah.

Hey, good afternoon. Thanks for taking the question can you give us an idea of how concentrated the U S. Regional contributions have been mostly on the coasts are we seeing totally disbursed update thanks.

And your next question comes from the line of Trevor All read from Oppenheimer. Your line is open.

Thank you Debbie thanks for joining US Keith is this a question you would like to thank please.

Yes, Im happy too because I'm really proud of the team the delivery and serving patients is coming across the U S. Our eight regions in our 71 territory business managers are all on the board with the majority of them as you can imagine from the successful launch in the first three quarters ahead of plan.

Thank you Tyler Thanks for joining us Skip this is a question you would like to thank please.

Yes, Im happy too because I'm really proud of the team the delivery and serving patients is coming across the U S. Our eight regions in our 71 territory business managers are all on the board.

So really pleased we went out and hired neurology experienced people.

And it's definitely paid off for us. Thanks.

The majority of them as you can imagine from the successful launch in the first three quarters ahead of plan. So really pleased we went out and hired neurology experienced people.

This concludes today's conference call. Thank you for your participation you may now disconnect.

And it's definitely paid off for us. Thanks.

This concludes today's conference call. Thank you for your participation you may now disconnect.

[music].

Okay.

Sure.

Okay.

[music].

Yes.

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