Q2 2020 Rigel Pharmaceuticals Inc Earnings Call

And welcome to Rigel Pharmaceuticals financial conference call for the second quarter Twentytwenty.

Operator: and welcome to Rigel Pharmaceuticals' financial conference call for the second quarter of 2020. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

At this time all participants are in all listen only mode a.

A brief question answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

Operator: As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs, and General Counsel. Thank you, Ms. Phants. You may begin.

It's now my pleasure to introduce our first speaker Dolly Vance, who is Rigel executive Vice President Corporate Affairs and General Counsel. Thank you Ms. Fancy you may begin.

Welcome to our second quarter 2020 financial results.

Dolly Vance: Welcome to our second quarter 2020 financial results and business update conference call. The financial press release for the second quarter was issued a short while ago and can be viewed, along with the accompanying slides for this presentation, in the news and events section of our Investor Relations page on our website at www.rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties and may cause actual results to differ from those forecasted. A description of these risks can be found in our annual report on Form 10-K for the year ended December 31st, 2019, and subsequent filings with the SEC, including our Q1 quarterly report on Form 10-Q. Any forward-looking statements are made only as of today, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our CEO, Raul Rodriguez.

The conference call.

That's a press release for the second quarter.

She just short while ago and can be viewed along with the accompanying slides for this presentation in the news and events section of our Investor Relations page on our website at Www dot gradual dot com.

As a reminder, during today's call remain make forward looking statements regarding our financial outlets and their plants economy for regulatory and product development.

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasts.

A description of these risks can be found in our annual report on form 10-K, whether you're ended December 31st.

20, my team and subsequent filings with the FCC, including our Q1 quarterly report on form 10-Q.

Any forward looking statements are made only as of today's date, we undertake no obligation to update these forward looking statements to reflect subsequent events or circumstances.

At this time I would like to turn the call over to our C E.

Hello Rodriguez.

Thank you Deli and thank you for joining us in our second quarter 2020 point actually participate.

Raul R. Rodriguez: Thank you, Dolly. And thank you for joining us for our second quarter 2020 financial and business update. Also joining me today are Tarek Balam, our Vice President of Marketing; our Chief Medical Officer, Wolfgang Dummer, and Dean Schorno, our CFO. Now turning to slide five.

Also joining me today October targets, along our vice President marketing.

Our chief Medical officer, what's kind of doing it had been true our CFO.

Now turning to slide five.

I'd like to introduce you to our key value drivers.

Raul R. Rodriguez: We would like to introduce you to our key value drivers. For those of you already familiar with our story, there is a new value driver theory that we are excited to discuss. Rigel's four key value drivers are growing global sales of Tavalisin ITP, creating and capitalizing on the opportunity of warm autoimmune hemolytic anemia, and exploring Talvalese for Fostamatin in the treatment of COVID pneumonia and COVID ARDS and subsequently looking at other pneumonias and ARDS caused by other health problems. And lastly, expanding our pipeline of programs based on key opportunities in immune-associated diseases. In Q2, we continue to make good progress across all of these areas, despite the challenges of the COVID pandemic. We are very proud today to tell you about it. In the recent quarter, we continued to grow Tavalee's sales on a year-over-year basis and reported today a 47% increase compared to the second quarter of 2019.

It does have you already familiar with our story, there's a new value driver.

We are excited to discuss.

Well I just four key value drivers are growing global sales.

Probably see RTP.

Trading in capitalizing on the opportunity for autoimmune hemolytic anemia.

Exploring how the Lisa <unk> the treatment of cobot pneumonia, and Kobani Rds and subsequently looking at other pneumonia in a rds caused by other health problems.

Lastly, expanding our pipeline programs based on key opportunities would need associated disease.

In Q2, we continued to make good progress across all of these areas. Despite the challenges because it comes up.

We are very well update to tell your profits.

In the recent corridor, we continue to grow top of each sales a year over year basis reported today, it's 47% increase compared to the second quarter of 29 cheap.

We're very pleased with it given the external challenges.

Raul R. Rodriguez: We are very pleased with this, given the external challenges. This is also a testament to the perseverance of our commercial organization and the highly differentiated and effective product we provide. Tariq will tell you more in a few minutes. As a reminder, outside of the U.S., we received approval for the use of phosphonamide in ITP in Europe in Q1 of this year. And, as recently announced, our product is now available in Germany and the UK by our partner, Griffin, under the brand name Calvilles.

This is also a testament to the perseverance about commercial organization into highly differentiated.

Product we provide.

Good how are you more in a few minutes.

As a reminder, outside the U.S., we received approval for the use of last night after night U.P. in Europe.

What you want it this year.

Yes, as recently announced a product is now available in Germany, and the UK buyout partner.

Under the brand name tablets.

Another potential opportunity commercial opportunity didn't get the logic. The shortage is what more automated hemolytic anemia or atri.

Raul R. Rodriguez: Another potential opportunity, and commercial opportunity in hematologic disorders is with warm autoimmune hemolytic anemia, or AIHA, which we feel needs to be a very large opportunity for right. AIHA is also an autoimmune disease, like ITP, where the body produces antibodies against a certain hematologic cell type, in this case, red blood cells.

Which we feel good to be a very large opportunity right.

Yeah I change is also an autoimmune disease like to pay the body produces antibodies against certain datalogic celltrak in this case red blood cells.

There's a real unmet need would give us a for new products for this indication.

Raul R. Rodriguez: There is a real unmet need given that there are no approved products for this indication. Based on the progress we have made to date, Rigel is in a position to potentially be the first approved product in AIHA. In addition, the syndication is very synergistic with IT. Both indications share the same prescribing hemalk physician, and that gives us the ability to leverage Taiwanese experience and knowledge. Currently being built by Roger Field. As we shared, we are exploring the opportunity for Tavalisse in the treatment of COVID-19 pneumonia and associated conditions. Calvary's Insignia Bishop may provide a unique and effective treatment to address the overreaction of the immune system and the destruction unleashed by the virus. Wolfgang will describe the scientific rationale, and the compelling preclinical data from a recently announced investigative sponsored trial in this, in this section.

Lepage the top of these experience and knowledge currently being built by the graduate period Force.

As we shared recently, we are exploring the opportunity for <unk> in the treatment of corporate 19 pneumonia and associated conditions.

<unk> may provide a unique and effective treatment to address the overreaction of the immune system.

And the destruction unleashed by the virus.

Cable describe the scientific rationale.

Are compelling preclinical data.

And Ah recently announced investigated sponsor trial and this and his section.

Lastly, a rip one inhibitor and our Iraq. One four inhibitor programs are both contains when trials and we are very excited about the potential for both of these assets.

Raul R. Rodriguez: Lastly, our RIP-1 inhibitor and our IRAC-1-4 inhibitor programs are both in Phase I trials, and we are very excited about the potential for both of these adds. I reckon RIF are very attractive immune targets, and based on early data, our molecules have demonstrated characteristics that give us a great deal of optimism about their potential. We continue to make progress in our discussions to secure a co-development and co-promotion agreement with these assets, and we believe that we will be able to do so by year end. All of these key value drivers are extraordinarily attractive market opportunities that we are well positioned to address. Tariq will now give us a commercial update.

I reckon with our very attractive immune targets and based on early data or molecules have demonstrated characteristics. They give us a great deal of optimism to their potential.

We continued to make progress in our discussion to secure Echo development co promotion cream, but these assets and we believe that we will be able to do so by year and.

All of these key value drivers are screwed in the early attractive market opportunities.

That we are well positioned to advanced.

Tarek will not give us a commercial update dark.

Thank you roll.

Tarek Balam: Thank you, Raul. Today, I will provide a review of our commercial efforts. As a reminder, Tovalese is indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. Additionally, as Raul mentioned, our product has been successfully launched by Griffin, our European collaborators, under the brand name of Tablas. We are excited to see the initial European markets come online, particularly with a broad indication that positions the product as a competitive alternative to the older standards of care. So, moving on to slide eight. We continue to gain momentum in the US, which accounts for over half of the approximately $2 billion Global ITP Markets. We achieved net product sales of approximately $15 million for the quarter, which is an increase of 47% year-over-year and 18% over the previous quarter.

Today I will provide a review of our commercial efforts as a reminder.

<unk> has indicated for the treatment of thrombocytopenia.

An adult patients with chronic IPP, who have had an insufficient response to a previous treatment.

Additionally is Rohan mentioned a product has been successfully launched by <unk> or European collaborators under the brand name of top less.

We're excited to see the initial European markets come online.

Particularly with a broad indication that positions the product as a competitive alternative to the older standards of care.

So moving on to slide eight.

We continue to gain momentum in the U S, which accounts for over half of the approximately 2 billion dollar.

Global IPP market.

We achieved net product sales of approximately $15 million for the quarter.

Which is an increase of 40%, 7% year over year and 18% over the previous quarter.

This is our highest quarter of say up to date, which is especially encouraging given the challenges that our field teams have been faced with.

Tarek Balam: This is our highest quarter of sales to date, which is especially encouraging given the challenges that our field teams have been faced with. Additionally, we see continued strength in our persistency rate, which should improve as healthcare providers become more familiar with the product and utilize it in earlier lines of treatment. We are pleased with this quarter's performance and the execution of our commercial efforts, particularly in these challenging times.

Additionally, we see continued strength in our persistency rate, which should improve is healthcare provider's become more familiar with a product.

And utilize it in earlier lines of treatment.

We are pleased with this quarters performance and the execution of our commercial efforts, particularly in these challenging times.

Physicians continue to express receptivity to top Elise.

Tarek Balam: Physicians continue to express receptivity to tablilis, highlighting the recent second line data analysis, the Unique Mechanism of Action, and having an alternative oral option.

Highlighting the recent second line data analysis.

The unique mechanism of action and having an alternative all option.

All said, we believe that over time enhanced physician access will allow us to accelerate are selling efforts to unlock incremental opportunity.

Tarek Balam: All said, we believe that over time, enhanced physician access will allow us to accelerate our selling efforts. Unknown Executive, Eun Yang, Nalin Tejavibulya, Rigel Pharmaceuticals Inc. So, I'm on slide nine. Central to these efforts will be the recent post hoc analysis of our Phase 3 trial in IT. We have previously presented the 78% response rate of Tavalis when utilized in the second-line setting, and here you can see this analysis of the data further broken down in more detail.

So on slide nine.

Central to these efforts will be the recent post hoc analysis of our phase III trial, an I T T.

We have previously presented to 78% response rate of <unk> when utilized in the second line setting.

And here you can see this analysis of the data further broken down in more detail.

As a reminder.

The initial presentation of response from our Phase III program focused on the entire overall study population.

Tarek Balam: As a reminder, the initial presentation of response from our Phase 3 program focused on the entire overall study population, which had an average duration of disease of eight and a half years and a median of four previous treatments. While many healthcare practitioners were impressed at the overall response rate in this clinical setting, additional information reflected in this graph highlights that Tavalli and its differentiated mechanism of action can achieve response rates similar to other treatment options when used earlier in the treatment cycle. We believe this more refined look at the data will enable clinicians to make decisions focused more on therapeutic approaches and individual patient needs and less on clinical trial response. So let's transition to how we are educating health care providers on this new information and providing support for their patients during this unique and unprecedented environment due to the COVID-19 pandemic. Slide 10, please.

Which had an average duration of disease of eight and a half years and a medium or for previous treatments.

Well, many health care practitioners or impressed at the overall response rate in this clinical setting the additional information reflected on this graph highlights the <unk>.

And it's differentiated mechanism of action can achieve response rate similar to other treatment options when used earlier in the treatment cycle.

We believe this more refined look at the data will enable clinicians to make decisions focused more on therapeutic approach and individual patient needs and less on clinical trial response rates.

So let's transition to how we are educating healthcare provider's on this new information.

And providing support for their patients during this unique an unprecedented environment due to the coke at 19 pandemic.

510 please.

As recent data suggests unfortunately, it seems that the coke at 19 pandemic is not abating in the U S.

Like other organizations, we have not seen improvements in terms of our opportunities to have face to face interactions with physicians.

That said our team has been doing a fantastic job utilizing virtual engagements to stay connected with our customers.

Tarek Balam: As recent data suggests, unfortunately, it seems that the COVID-19 pandemic is not abating in the U.S. Like other organizations, we have not seen improvements in terms of our opportunities to have face-to-face interactions with physicians. That said, our team has been doing a fantastic job utilizing virtual engagements to stay connected with our customers and to continue education on tablilis. The new data analysis we just reviewed is a valuable tool that we have integrated into our selling materials and is being used by our field teams in clinical conversations with the physician community. Due to its recency, awareness of the data is relatively low amongst our customer base right now, but it is growing, and we are encouraged by the positive feedback from physicians. Importantly, this post hoc analysis was recently published in the British Journal of Hematology.

And to continue educating on top of Leafs.

The new data analysis, we just reviewed is a valuable tool that we are integrated into our selling materials and it's being used by our field teams and clinical conversations with the physician community.

Do do it's recency awareness of the data is relatively low amongst our customer base right now.

But it is growing and we are encouraged by the positive feedback from physicians.

Importantly, dispose how can I assist was recently published Anabranch journal of Hematology.

This is a highly respected journal and we believe this recognition can help improve the awareness and conversation about this data amongst treating physicians.

We believe this is a growing opportunity supported by the endorsement of Kols and now a highly respected peer reviewed publication that reinforces the benefits of using totally an earlier lines of treatment.

So turning to slide 11.

We are very excited to have a product that is now launched and market outside of the U S, namely, Germany in the U K.

Our European collaborator Cripples is planning a phased rollout over the next 18 months across the rest of Europe.

We also continue to make progress with our other partners listed on the slide.

Tarek Balam: This is a highly respected journal, and we believe this recognition can help improve awareness and conversation about this data amongst treating physicians. We believe this is a growing opportunity supported by the endorsement of KOLs and now a highly respected peer-reviewed publication that reinforces the benefits of using Talvalese in earlier lines of treatment.

Look forward to increasing the global footprint <unk> Boston Magnum.

And finally.

With a solid foundation in place that will support our commercial success and I T P.

We're excited to execute on our strategy to make foster matinee of a franchise product.

Specifically the opportunity to have a potential indication and warm auto immune hemolytic anemia.

Tarek Balam: We are very excited to have a product that is now launched in markets outside of the US, namely Germany and the UK. Our European collaborator, Gripples, is planning a phased rollout over the next 18 months across the rest of Europe. We also continue to make progress with our other partners listed on this slide and look forward to increasing the global footprint of Tavolese, Foster Matten, and finally, with a solid foundation in place that will support our commercial success in ITP. We are excited to execute on our strategy to make Foster Matinib a franchise product, and specifically, the opportunity to have a potential indication in warm autoimmune hemolytic anemia, or AIHA. To give us an update on the progress we are making on this development program, I will now hand the call over to my colleague, Wolfgang Dummer, our Chief Medical Officer.

Or a IHA.

To give us an update on the progress we were making on this development program I will know him to call over to my colleague Wolfgang tumor or Chief Medical Officer Wolfgang.

Thank you Tarek good afternoon, everybody [noise].

I'd like to begin on slide 13.

With regards to a program and warm all the immune hemolytic anemia, we continue to be well positions to become the first of proof drug for this indication.

We have the only company currently interface three pivotal trial.

And we have currently 44 patients randomized, which is approximately half a study.

I'd also like to add that we are the only company that has phase too clinical data already in <unk> M. A H a.

We view AIA T as in attractive opportunity do too important synergies with a commercial ATP business, where continuously Eddie educating physicians or mechanism of action efficacy safety and faith clinical use of Cavalese in the I T P market and this doctors or.

Wolfgang Dummer: Thank you, Tarek. Good afternoon, everybody.

Wolfgang Dummer: I'd like to begin on slide 13. With regard to our program in warm or immune hemolytic anemia, we continue to be well-positioned to become the first approved drug for this indication. We're the only company currently in a phase 3 pivotal trial, and we currently have 44 patients randomized, which is approximately half of the study. I'd also like to add that we are the only company that has Phase II clinical data already in worm AIHA. We view AIHA as an attractive opportunity due to important synergies with our commercial ITP business. We're continuously educating physicians on the mechanism of action, efficacy, safety, and best clinical use of Cavalisse in the ITP market. And these doctors are generally the same that treat AIHA patients.

Generally the same to treat H E patients.

This should tenor it's broad awareness of Cavalese as a treatment option for a I N G right upon lunch.

Turning to slide 14.

Here's a brief update on our ongoing phase three trial.

Is mentioned, we have currently 44 patients randomised.

And sites have reopened recently after the pandemic shut down.

It is too early to precisely predict timing of enrollment completion at this point.

We will.

Update as we get a better understanding how the pandemic affects recruitment over the coming months.

However, I would like to emphasize that we now have over 90 sides activated in 22 countries.

Having an established operational foundation in this environment is very important.

Wolfgang Dummer: This should generate broad awareness of Cavalisse as a treatment option for AIHE right upon launch. Here's a brief update on our ongoing Phase 3 trial. As mentioned, we currently have 44 patients randomized, and sites have reopened recently after the pandemic shutdown. It is too early to precisely predict the timing of enrollment completion at this point. We will update you as we get a better understanding of how the pandemic affects recruitment over the coming months. However, I would like to emphasize that we now have over 90 sites activated in 22 countries, and having an established operational foundation in this environment is very important. Since some countries are likely to normalize more quickly than others,

Since some countries I'll likely to normalize more quickly than others <unk>.

We will be able to ramp enrollment on our country by country basis, if the situation permits.

So we believes that as soon as the Kobe, 19th situation normalizes richaud regained momentum or all the quickly and efficiently.

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Switching to Kobe 19, let me talk you through our program is to have a lease or force them up.

19.

Moving to slide 60.

There is still a strong needs to effectively treat cope with 19 and it does these complications.

Both of them up and they can have a mother latorre effect in several ways on the hyporeactive immune system, which causes the severe and the lifestyle evening cases at a point, where the viral load itself is already decreasing or eliminated.

Wolfgang Dummer: We will be able to ramp enrollment on a country-by-country basis as the situation permits. So we believe that as soon as the COVID-19 situation normalizes, we should regain momentum rather quickly and efficiently. Slide 15. Switching to COVID-19, let me talk you through our program with Tavalis or Foster Martin in COVID-19. Moving to slide 16.

While a vaccine would be important to generate throw the immunity, they're still use and there will continue to be a strong neat for safe and effective treatment options, including possibly forced him up and it.

Wolfgang Dummer: There is still a strong need to effectively treat COVID-19 and its disease complications. Foster Martinib can have a modulatory effect in several ways on the hyperreactive immune system, which causes severe and life-threatening cases at a point where the viral load itself is already decreasing or eliminated. While a vaccine would be important to generate broader immunity, there still is, and will continue to be, a strong need for safe and effective treatment options, including possibly foster maternity. Postamatinib is a great candidate to study, as it is an approved, well-understood product, easy to take as a pill, and has a large safety database of over 4,500 patients treated in clinical trials.

Most of them up and it is a great candidate to study as it is an approved well understood product easy to take his appeal with a large safety database of over 4500 patients treated in clinical trials.

The next three slides I will lead you through the clear scientific rationale for <unk> you can cope with 19.

Before I speak about the clinical trial Imperial College.

This slide 17 provides a simplified overview of the role of sick signalling in the cold with 19 Petrogenesis.

Please have a look at the virus politicking at the top middle of the image.

In the early stages off the infection, the replicating virus causes lung epithelia so destruction.

And release of so called damage associated molecular pet him stamps.

Wolfgang Dummer: On the next three slides, I will lead you through the clear scientific rationale for sick inhibition in COVID-19 before I speak about the clinical trial at Imperial College. This slide 17 provides a simplified overview of the role of sick signaling in COVID-19 pathogenesis. Please have a look at the virus particle at the top middle of the image.

And pathogen associated Molecularly molecular patterns, pam's, which find to see lichten receptors. He on the right I'll see image ceiling signaling through select them receptors can lead to excessive inflammatory cytokine reviews.

<unk> from basketball or in the T V ourselves.

As well as two neutrophil activation entitled toxicity by a process cold mitosis.

Wolfgang Dummer: In the early stages of the infection, the replicating virus causes lung epithelial cell destruction and the release of so-called damage-associated molecular pattern stamps and Pathogen-Associated Molecular Patterns (PAMPs), which bind to C-lectin receptors on the right of the image. Signaling through C-lectin receptors can lead to excessive inflammatory cytokine release and coagulopathy from vascular endothelial disease All these events can damage the lungs and even other organs, such as the kidneys or the heart.

All these events can damage the lungs, and even other oregon's such as the kidneys or the heart.

Inhibition was supposed to him up and it can reduce this highly inflammatory process.

On the top left of the image you can see the second main reason for a hyper reactive immune system.

S. A response to the viral infection, our immune systems begin to make anti Sars Kobe two antibodies.

These antibodies then form immune complexes with a virus.

Which binds two extra got my receptor expressing so such as macrophages dendritic cells monocytes.

And in some patients can induce excessive release of inflammatory cytokines, such as I O. One beta I O six I O eight.

Wolfgang Dummer: Thick inhibition with prostamatinib can reduce this highly inflammatory process. On the left side of the image, you can see the second main reason for a hyperreactive immune system. As a response to the viral infection, our immune systems begin to make anti-SARS-CoV-2 antibodies. These antibodies then form immune complexes with the virus, which binds to FC-gamma receptor-expressing cells such as macrophages, dendritic cells, monocytes, and in some patients, can induce excessive release of inflammatory cytokines such as IL-1 beta, IL-6, and IL-8. Here, too, sick inhibition with foster matinib can ameliorate the cytokine storm and prevent organ damage. Postamatinib is the only sick inhibitor approved that may interfere with the pathology of COVID-19 at multiple points through multiple cell types and could therefore work in COVID-19-related organ damage, pneumonia, and also ARDS of viral and other etiologies. This is not an entirely new concept, as we have preclinical data from a model in ARDS.

Here too sick inhibition with first and last name <unk> ameliorate the sidewalk I'm storm and prevent Oregon damage.

Awesome awesome, if it's the only sick and he'd be there that me is the only sick inhibitor approved that may interfere with the pathology of Kobe 19 at multiple points through multiple so types and could therefore brook in Cook with 19 related related Oregon damage pneumonia.

And also a R D S a viral and other etiology.

This is not an entirely new concept as we have preclinical data from a muddle in <unk>.

Mm slight eight.

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You see an executive summary of those experience with our four O six which is the active metabolite or forced him up and it <unk>.

On the list you see the histology of lung tissue on the four different experimental circumstances.

[noise] palace healthy lung tissue with clear alveoli weird transport of oxygen into the blood happens.

On the top right you see the same thing when only close to him up and it is administered with no negative impact on the long.

On the lower left U C. A R. T S induced by O P S, which led to massive information fluids instead of debris in the alveoli, making oxygenation off the blood difficult or insufficient.

Wolfgang Dummer: and E.R. News.

Wolfgang Dummer: On slide eight, 18, you see an executive summary of their experience with R406, which is the active metabolite of foster moth. On the left, you see the histology of lung tissue under four different experimental circumstances. After this... Healthy lung tissue with clear alveoli where transport of oxygen into the blood happens. On the top right, you see the same thing when only prostamatinib is administered with no negative impact on the lungs. On the lower left, you can see ARDS induced by LPS, which leads to massive inflammation, fluid, and cell debris in the alveoli, making oxygenation of the blood difficult or insufficient. On the lower right, you can see that foster matinib had a clear beneficial effect on this pathology. And not surprisingly, as depicted on the panel to the far right, this led to survival of the mice with ARDS that were treated with fortamatin. I will show you two additional references recently published, independent of Rigel, that further support the scientific rationale for Foster Madness. The first on the left comes from MIT and Harvard.

On the lower right you can see the first time I've been to pay the clear beneficial effect on this pathology.

And not surprisingly is depicted on the panel to the four right.

This led to survival of the mice with <unk> that were treated was forced him up <unk>.

On slide 19.

I show you two additional references recent recently published independent of Rachael. That's further support the scientific rational proposed a mountain.

The first one the lift comes from M I T and Harvard.

They screen 3713 compounds to identify any that are F. D. A approved and reduce new seen one <unk>.

<unk>, one is a biomarker, which predict the development of acute lung injury M. A R D S and correlates with poor clinical outcomes.

Of all those compounds screened forced him up <unk> only to decrease expression of Neuston, one and is already if they approved and therefore was proposed by the authors for rapid repurposing for patients with Coke with 19 lung disease.

The other paper on the right referenced is from Amsterdam University Medical Center.

The researchers there demonstrated that are four O six the active metabolite or for some atnip blocked macrophage hyper inflammatory responses to a combination of immune complexes formed by anti spike agg from severely ill Corbett 19 patients.

Wolfgang Dummer: They screened 3,713 compounds to identify any that are FDA approved and reduce Mucin-1. New Sin 1 is a biomarker that predicts the development of acute lung injury and ARDS and correlates with poor clinical outcomes. Of all those compounds screened, fortamatinib was the only compound to decrease expression of Mucin 1 and is already FDA approved, and therefore it was proposed by the authors for rapid repurposing for patients with COVID-19 lung disease. The other paper on the right, referenced, is from Amsterdam University Medical Center. The researchers there demonstrated that R406, the active metabolite of fostamatinib, blocked macrophage hyperinflammatory responses to a combination of immune complexes formed by anti-spike IgG from severely ill COVID-19 patients. Anti-spike IgG levels correlated with the severity of COVID-19. Thus, the ability of R406 to inhibit anti-spike IgG-mediated hyperinflammation suggests that it could play a role in the prevention of cytokine storm, pulmonary edema, as well as thrombosis associated with severe COVID-19. My last slide, 20, depicts the Imperial College Investigator Sponsored Trial that has recently been opened.

Anti Spike I G G Liberals correlated with the severity of cold with 19.

Plus the ability of <unk> 062, inhibits anti spike I G. G mediated hyper inflammation suggest that it could play a role in the prevention of cytokine storm put them on every team as well as thrombosis associated with the T V you could with 19th.

My last like 20.

He picks the Imperial College investigate this phone to trial that has been opened recently.

This is a three arm randomized trial was supposed to come up Nick or so little nip.

<unk> standard of care versus standard of care alone.

The first page real randomize 57 patients <unk> for a total of 171 patients.

At which point in in Terminalis this will be conducted.

Based on that the second stage will enroll an additional 95 patients per arm for a total study size of 456.

The treatment duration is 14 days in patients will be followed Tuesday 28.

Really excited to have this iced tea up and running because we expect this could provide initial clinical data in a relatively near future.

With that L him to call over to Rosewood <unk> Road.

Thank you Okay Slide 21 please.

You wanted to give you an R. V. You have the opportunity for fast Amanda and the treatment of progression of Coke with pneumonia N. A R. D S as well as pneumonia is more Brunswick.

Wolfgang Dummer: This is a three-arm randomized trial with Fostamatinib or Ruxolipinib plus standard of care versus standard of care alone. The first stage will randomize 57 patients per arm for a total of 171 patients, at which point an interim analysis will be conducted. Based on that, the second stage will enroll an additional 95 patients per arm for a total study size of 456. The treatment duration is 14 days, and patients will be followed to day 28. We're excited to have this ISP up and running because we expect it could provide initial clinical data in the relatively near future. With that, I'll hand the call over to Raul Rodriguez. Raul

It is incredibly exciting.

Potentially provide a much needed therapy to address the ravages of the worst pandemic in our lifetimes.

Cause you know, it's the overactive immune system, which causes the majority of fatalities uncooperative effective patients.

And it's Wolfgang shared you believe that first Amanda may I help a unique and beneficial immunomodulating Tory impact.

This is a near term opportunity that can be quite size of a give them a large number of patients impacted the.

The impure College I S T as in other potential iced teas kept provider early read on the potential benefit of past Amanda and do so in a broad range of hospitalized <unk> Kirby.

<unk> two more <unk> some more severe.

And with a broad range of T treatment bathrooms.

Exciting to possibly provide I'll put it in this extraordinarily large and near term opportunity.

Raul R. Rodriguez: Thank you, Wolfgang, on slide 21. We wanted to give you our view of the opportunity for Foster Mandate in the treatment of progression of COVID pneumonia and ARDS, as well as pneumonia's wider spectrum. It is incredibly exciting to potentially provide a much needed therapy to address the ravages of the worst pandemic in our lifetime. As you know, it's the overactive immune system that causes the majority of fatalities in COVID-infected patients. And as Wolfgang shared, we believe that foster madness may have a unique and beneficial immunomodulatory impact. This is a near-term opportunity that can be quite sizable given the large number of patients in. The Imperial College ISTs and other potential ISTs can provide an early read on the potential benefit of foster care and do so in a broad range of hospitalized patients from COVID, from mild to more severe, and with a broad range of It's exciting to possibly provide a benefit in this extraordinarily large and Near-Term Opportunity. This also sets us up for exploring post-traumatic in the treatment of pneumonia and ARDS from other sources, other origins, beyond COVID, both viral and non-viral. There are currently no approved agents for this.

It's also set this up towards sporting fast Amanda and the treatment of pneumonia M. A R. D S from other sources or their origins beyond Kobe.

Five O N non violent.

There are currently no approve ages for this every year in the U S. There are over 1.3 million patients hospitalized for Pneuomonias.

Approximately 200000 of these progressed to a R D S.

To the same rationale that we laid out today, we can do that first may I may have a better for ya.

The covered critical experience with further confirm this and position this to pursue this large and enduring opportunities.

Let me move on to slide 20th.

That's 133 I'd like to tell you about our four two valued driver.

Expanding a python.

But we have the very rich history of discovery and developing attractive molecules. These includes all of the opportunities for you to discuss with today.

We focus on the inhibition is key signaling pathways that are critical to many immune mediated diseases.

This includes both immune disease as well and not is not immune diseases, such as in areas that hematology oncology.

We have three house programs that we have discussed today <unk> R. O R. R O second Ya butter.

In Iraq, one four inhibitor and the ZIP wanted Hamburger program.

I recommend for inhibitor, the only molecule that inhibits boat the Iraq, one and Iraq for pathways and therefore, it's more profoundly immunosuppressive another Iraq for only programs in preclinical studies, we've shown to block inflammatory cytokines production in response to told like this.

Raul R. Rodriguez: Every year in the U.S., there are over 1.3 million patients hospitalized for pneumonia, and approximately 200,000 of these progress to ARDS. For the same rationale that we laid out today, we believe that fostomab may have a beneficial effect. The COVID clinical experience would further confirm this and position us to pursue this large and enduring opportunity. Let me move on to slide 23.

Doctor T O R N I O one receptor families England.

I need the phase one help you volunteer study me achieve proof of mechanism results.

Lowering inflammatory cytokines from L. P S challenge and demonstrated paperwork P K profile.

Raul R. Rodriguez: On slide 23, I'd like to tell you about our fourth key value, expanding our pipeline. And Rigel, we have a very rich history of discovering and developing attractive molecules, which include all of the opportunities we are discussing today.

We also have four posters on this program presented at the reset you are are meeting this past quarter.

With a root one program. We recently completed multiple ascending does stage of our phase one study.

<unk>, we have identified adult screens that we believe the safe and well within be expected clinical efficacy range.

Cause previously mentioned, we have making progress identify.

So I also identify a C N S <unk>.

Raul R. Rodriguez: We focus on the inhibition of key signaling pathways that are critical to many immune-mediated diseases. This includes both immune diseases, as well as non-immune diseases, such as in areas such as hematology and oncology. We have three health programs that we have discussed today. Tavalisse, our oral sick inhibitor, and the IRAC1-4 inhibitor, and the RIP-1 inhibitor. Our IRAC1-4 inhibitor is the only molecule that inhibits both the IRAC1 and IRAC4 pathway, and therefore is more profoundly immunosuppressive than other IRAC4 inhibitors. In preclinical studies, we have shown to block inflammatory cytokine production in response to toll-like receptor TLR and IL-1 receptor family signaling. And in the Phase I Health Development Peer Study, we achieved proof-of-mechanism results, lowering inflammation-related cytokines from the LPS Challenge, and demonstrated a favorable BK profile.

Inhibitor molecule for C N S on vacations and moving it into the clinic next year.

In addition to these we have four partnered clinical programs, which include to Jack inhibitors. Another T immune signal the pathway.

And you can see these assets provide us with many options to develop and create Bellevue provides including moving our programs forward ourselves.

Perjury and various structures divided the opportunities geographically or by size of indication.

For a rip one in Iraq, one Ford programs.

We are currently in discussions with potential large farmer partners implant, including a code development co promotion agreement by your N.

In addition, we're putting in place further iced teas to allow us to explored the broad utility.

Our immune modulation inhibitors.

And speaking of which it's like 24, you see the broad range of possible indications that are available to these molecules. Some of these weird, let's go with Partridge C with root beer alright inhibitors somebody will look store for ourselves with us so alone such as the I T. P E I H a potentially covered.

Raul R. Rodriguez: We also had four posters on this program presented at the recent ULAR meeting this past quarter. With our RIP-1 program, we recently completed the multiple ascending dose stage of our Phase I study. Importantly, we have identified a dose range that we believe is safe and well within the expected clinical efficacy. As previously mentioned, we are making progress identifying and identifying a CNS RIP, a RIP inhibitor molecule for our CNS indications, and moving it into the clinic next year. In addition to these, we have four partnered clinical programs, which include two JAK inhibitors. Another key immune signaling pathway.

Pneumonia.

Are brought portfolio of the new modulators provide us with significant help with you.

Now with that I will turn the call over to D for a quarterly financial update.

<unk>.

That's zero turning to slide 26 second quarter of 2020, we shipped 1632 bottles to our specialty distributors 1515, and those bottles were shifted patient clinics for 117 bottles remained in or distribution channels at the end of.

A quarter as of June 30th a total of 708 bottles remained in our distribution channels, we reported that products salesman Tahoe east of $15 million 47 per cent increase compared to the second quarter of 2019.

Net kotick salesman totally for recorded and Adam estimated that sounds charge backs rebates returns co pay a system another allowances at $3.4 million or gross Tonight adjustment, which is approximately 18 three per cent of gross product sales.

Raul R. Rodriguez: As you can see, these assets provide us with many options to develop and create value for life, including moving our programs forward ourselves, partnering in various structures, dividing the opportunities geographically or by size of indication for a RIP-1 and IRAP-1-4 program. We are currently in the

Before I move on from that product sales, let me comment brief round, our expectations for the third quarter.

Well, we're pleased with the continued growth and our Tabriz sales and a second quarter and expect to see continued growth and a third quarter of 2020 impacted covered 19 on our business that started and the ladder part of the first quarter continues and remains uncertain.

Raul R. Rodriguez: with potential large pharma partners and plan on concluding a co-development and co-promotion agreement by year-end. In addition, we are putting in place further ISD to allow us to explore the broad utility of our immune-modulating inhibitors. And speaking of which, on slide 24, you see the broad range of possible code indications that are available to these molecules. Some of these we will explore with partners, say with RIP or IRAC inhibitors. Some we will explore for ourselves, with ourselves alone, such as ITP, AIHA, and potentially COVID pneumonia. Our broad portfolio of immune modulators provides us with significant opportunities. Now, with that, I will turn the call over to Dean for a quarterly financial update. Dean?

<unk> highlighted we'd made great strides optimize nor do I need to access our position community remotely and to provide the meditation suffering from quantify T. T M. A U S. <unk> once the significant impact and restrictions caused by October 19, or behind us in the future begins to normalize we expect to see <unk>.

And your strength and gross and our business under the next slide.

In addition to net product sales righteous contract revenues from collaborations was $1 million for the three months and June 30th 2020, which consists of deferred revenue from our collaboration with <unk> related to the performance of certain research and development services.

Dean L. Schorno: Thank you, Raul. Turning to slide 26, for the second quarter of 2020, we shipped 1,632 bottles to our specialty distributors. 1,515 of those bottles were shipped to patients and clinics, while 117 bottles remained in our distribution channels at the end of the quarter. As of June 30th, a total of 708 bottles remained in our distribution channels.

Moving onto costs and expenses a cost of products. They also was approximately $279000 for the second quarter of 2020.

Total cost some expenses were $33.4 million and the second quarter of 2020 versus 31 $7 million and the second quarter of 2019.

Dean L. Schorno: We reported net product sales from Tavolese at $15 million, a 47% increase compared to the second quarter of 2019. Our net product sales from Tavolese were recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances, which is approximately 18.3% of gross product sales.

Increase in total cost some expenses was primarily due to the third party costs related to Rogers I'm doing pivotal phase three study in Walmart or you mean, hemolytic anemia research and development costs related to other clinical programs and personnel related Cos, partially offset my stock finish compensation expense.

And we look towards the back half of 2020, we continue to expect our four year total cost some expensive to increase by approximately 15% to 20% as compared to 2019 as we continue our commercial expansion and further a research and development pipeline inclusive ever Cove at 19 effort.

Dean L. Schorno: Before we move on from that product sales, let me comment briefly on our expectations for the third quarter. While we're pleased with the continued growth in our top leased sales in the second quarter and expect to see continued growth in the third quarter of 2020, the impact of COVID-19 on our business that started in the latter part of the first quarter continues and remains uncertain. As we've highlighted, we've made great strides in optimizing our ability to access our physician community remotely and to provide the many patients suffering from chronic ITP in the U.S. with access to Kabbalah.

That our team is discussed.

We ended the corner with cash and short term investments and approximately $92.5 million.

During the second quarter, we access the second $10 million transferred from our $60 million turned my own credit facility mid cap financial this facility provided company with access to an additional $40 million, which is subject to the cheeseburger a certain conditions.

I'd like to turn the call back over to rural Rural.

Dean L. Schorno: Once the significant impact and restrictions caused by COVID-19 are behind us, and the future begins to normalize, we expect to see continued strength and growth in our business. As shown in the next slide, in addition to net product sales, Rigel's contract revenues from collaborations were $1 million for the three months ended June 30, 2020, which consists of deferred revenue from our collaboration with Griffles related to the performance of certain research and development services. Moving on to cost and expenses, our cost of product sales was approximately $279,000 for the second quarter of 2020. Total costs and expenses were $33.4 million in the second quarter of 2020 versus $31.7 million in the second quarter of 2019. The increase in total costs and expenses was primarily due to third-party costs related to Rigel's ongoing Pivotal Phase III study in warm autoimmune hemolytic anemia, research

Well thank you do.

Moving on to slide 28.

The covered pandemic is clearly impacted our business, but it's also presented opportunities for us to potentially contribute to a solution.

Can I talk to her energize, we are about this prospects, let me summarize our efforts going forward and each of the four cat key valued drivers for the company.

We will continue to grow to have at least in the U S. I T. P market and we're excited about the use of tell the recent earlier lines of therapy and the data is that we have to support disposition.

Similarly, we look forward to supporting our partner Griffith as they continue as they introduce physicians in patients in Europe to tub lesson.

We will work to complete the enrollment of R. A H a phase III study with the re initiation to screaming and we look forward to enrollment increasing.

We will expand our currently in this area and move forward to completion of that trial and finally, a N D. A.

We will explore have tell the least could provide potentially potentially provide patience with coca related pneumonia, a much needed therapy.

And we will continue to a bad sorry, ZIP one in Iraq, one for programs, putting in place of partnership by ear and.

Before I turned the call over your questions I wanted to just make a quick note I wanted to highlight in addition to our management team Dave Santos.

Will be joining the regulars are cheap commercial lobster.

Dean L. Schorno: and others. Thank you. This is a presentation by the Center for Snow Related Disorders.

<unk> date brings over 30 years of experience within Battology oncology areas.

Various commercial leadership grilled with numerous successful companies I think it'll be a great addition to the team and we look forward.

Dean L. Schorno: Partially offset by stock-based compensation expense. As we look towards the back half of 2020, we continue to expect our full year total costs and expenses to increase by approximately 15 to 20% as compared to 2019, as we continue our commercial expansion and further our research and development pipeline, inclusive of the COVID-19 efforts that our team has discussed.

To his contributions in helping us advance our commercial leopards and and then I also Wanna. Thank sorry forest contributions and look forward to those as well.

So with that I'd like to open up the culture questions.

Thank you.

We went all be conducting a question and answer session.

If you would like to ask a question. Please press star one on your telephone keypad.

A confirmation tone would indicate your line isn't the question Q.

You May press Star too if you would like to remove your question from the Q.

Dean L. Schorno: We ended the quarter with cash and short-term investments of approximately $92.5 million. During the second quarter, we accessed the second $10 million tranche from our $60 million term loan credit facility with MidCap Financial. This facility provides the company with access to an additional $40 million, which is subject to the achievement of certain conditions. With that, I'd like to turn the call back over to Raul.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please while we pull for questions.

Our first question today comes from you and Yang Jeffries. Please proceed with your question.

Hi, This is an island on for you just a couple of questions, particularly on the Coke at 19 pneumonia questions, sorry, I uncovered 19 trials.

Could you give us some details on what the pathway for getting an approval to non coke with 19 pneumonia might look like.

Raul R. Rodriguez: Thank you, Dean. Moving on to slide 28. The COVID pandemic has clearly impacted our business, but it's also presented opportunities for us to potentially contribute to a solution, and I cannot tell you how excited we are about this. Let me summarize our efforts going forward in each of the four key value drives for the company. We will continue to grow Taveliz in the US ITP market, and we're excited about the use of Taveliz in earlier lines of therapy and the data that we have to support this position. Similarly, we look forward to supporting our partner, Griffiths, as they continue to introduce physicians and patients in Europe to tablets. We will work to complete the enrollment of our AIHA Phase 3 study with the re-initiation of screening, and we look forward to enrollment increases. We will expand our current lead in this area and move forward to completion of that trial and filing an NDA. Additionally, we will explore how Tavilis could potentially provide patients with COVID-related pneumonia, a much-needed therapy.

Following running a child and coke at 19 pneumonia.

And which type of trial, we'd have to run which patient populations might be recruited and I'll take my child E. Thank you.

[noise]. Thank you I'll eat I'll I'll make a couple of come into this who's going to also and other comments so.

We were very interested in <unk> M. A R. D. S prevention, some time ago and that publication that what can sure.

Published in 19 before this call with my debit card killed punished.

Scenario with a report that our product could have real potential and promptly speaking because there's several different T sources.

Pneuomonias viral not viral bacterial.

Others auto immune for example, so there are several different pockets of those who we.

There's a great opportunity for a product to meaningfully contribute to stop that progression and as I mentioned I think this is an annual ongoing issue that we could have a tremendous opportunity to benefit patients.

Exactly there's nothing approved in this area.

So there isn't a playbook that's I'll gladly written that we could simply copy, but we may have to look at other proximate Ah models for such a circumstance and to be work with the F. D. Ah closely in order for us to to pursue that I think the coke.

Raul R. Rodriguez: And we will continue to advance our RIP-1 and IRAC-1-4 programs, putting in place a partnership by year-end. Before I turn the call over to questions, I want to just make a quick note. I wanted to highlight an addition to our management team. Dave Santos will be joining Rigel as our Chief Commercial Officer. Dave brings over 30 years of experience in rheumatology and oncology areas in various commercial leadership roles with numerous successful companies. I think he'll be a great addition to the team and we look forward to his contributions in helping us advance our commercial efforts. And with that, I also want to thank Tarek for his contributions and look forward to those as well. So with that, I'd like to open up the call to your questions. Thank you.

Pneumonia experienced to be very helpful. Because it has the same mechanism as some of these others. So that might itself needing a very useful precedent for how we go about it.

Yeah. Thank you very much enter.

Alright.

No no no go ahead.

[laughter], we have one second delay so I support morality thing obviously, our first step would be to generate solid theater in cope with 19, then is always depending on how large do you pick sizes you can take your learnings onto the design of non Kobe to a O D S.

Trial. So in other words, the larger that you picked says the smaller potential trial needed. So so at this point is probably a little bit too premature to to determine what the sample size potential childhood looked like.

Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue... You may press star 2 if you would like to remove your question from the queue.

Thank you very much just one more question if I may so pick one is for dean so you'd previously mentioned that the funding for the Cougars 19 childhood come out of funding intended for US further work on <unk>.

Could you. Please clarify if there were other indications beyond I T. T N T V. A S. A that the company had intended to explore thank you very much.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we pull for questions. Our first question today comes from Eun Yang of Jefferies. Please proceed with your question. Hi, this is Nalin on behalf of Eun. Just a couple of questions, particularly

Yes.

Let me start and then I'll I'll ask Ronald.

Wrap up the comments on this with any incremental thoughts, but what we will we've described always is that we have exclusivity with.

Foster mountain, they're probably through entered into 2032 and with that with that long runway. We've always had the intention to explore incremental opportunities with the with this with just ask that we believe that and therefore, we've always we've always plan.

Unknown Executive: Unknown Executive, Yigal Nochomovitz, Raul Rodriguez, Dean Schorno, Kalpit Patel, Carly Kenselaar, Richard Miller, Raymond Furey, Unknown Executive, Eun Yang, Nalin Tejavibulya, Richard Miller, Raymond Furey, Unknown Executive, Eun Yang, Nalin Tejavibulya, Richard Miller, Raymond Furey, Unknown Executive, Eun Yang,

From a cost perspective from an operating expense perspective to make investments in those areas, we believe that today.

An optimal way to utilize resources as to.

Raul R. Rodriguez: Thank you, Nalin. I'll make a couple of comments and ask Wolfgang to also add other comments. You know, we were very interested in pneumonia and ARDS prevention some time ago, and that publication that Wolfgang shared was published in 19, before this COVID pandemic came upon us. And so it's an area where we thought that our product could have real potential. And broadly speaking, because there are several different key sources of pneumonia, viral, non-viral, bacterial, others, autoimmune, for example. So there are several different pockets of those.

<unk> <unk>.

Covered related pneumonia and then the extension D. A R. D S. Non kovida, we've talked about and so today those are really the focus of our at least are near term operated an expense rename it's choices into the future.

To invest in foster amount and they've been other ways, but today, it's really focused on me to covid related opportunity and then the possibility into non cook at a R. D S.

The only thing to add there is is that how like you know second edition has a very broad rule, it's not solely.

F C receptor signaling as it is in auto immune diseases Lucky I H a R. I T V. Though it's it's quite beneficial there, but it has a broader role in immune modulation another cell types.

Raul R. Rodriguez: We think there's a great opportunity for our product to meaningfully contribute to stopping that progression. And, as I mentioned, I think this is an ongoing issue that we could have a tremendous opportunity to benefit patients. Exactly, there's nothing approved in this area, so there isn't a playbook that's all readily written that we could simply copy. But we may have to look at other proximate models for such a circumstance and work with the FDA closely in order for us to pursue that. I think the COVID pneumonia experience would be very helpful because it has the same mechanism as some of these others. And so that might itself be a very useful precedent for how we go about it.

And the other mechanisms in this covered opportunity helps how I like that and we'd like to take advantage of that because I think it provides us with a really useful tool I think people need begun to scratch the surface of the potential for sick and efficient.

The next question comes from Yeah, I draw Nacho Margravate of Citigroup. Please proceed with your question.

Thank you.

<unk>.

I guess you may have seen that Denali, and then Sanofi announced plans to do a covered trial with their ripped one inhibitor.

So you have one as well have you given any thought to other you would take our 552 into a coke a study in addition to to first amendment.

Wolfgang Dummer: Wolfgang?

Hello. Thank you for your question you know, what's very interesting about that it it absolutely right in and it <unk> may I have potential as well and gripped inhibitors and treatment of Kobe.

Wolfgang Dummer: Thank you very much. Thank you.

Wolfgang Dummer: [inaudible]

Wolfgang Dummer: No, no, go ahead. We have a one second delay.

Wolfgang Dummer: So I support what Raul is saying. Obviously, our first step would be to generate solid data in COVID-19. Then, as always, depending on how large the effect size is, you can take your learnings into the design of a non-COVID ARDS trial. In other words, the larger the effect size, the smaller the potential trial needed. So at this point, it is probably a little bit too premature to determine what the sample size for such a trial would look like.

We are excited about about tell the leafs since we thank the mechanisms should work here. The the proof of concept data that we shared today not just in our hands, but really in the hands of independent collaborators is really compelling and it has a difference for a mother development states products such as.

Our own five 520 Zip behavior.

Is that it's approved it's on the market. It's commercially available today, if if doctors wanted to use it a very well could even today.

Wolfgang Dummer: Thank you very much. Um, just one more question, if I may. Um, so this one is for Dean. Um, you previously mentioned that the funding for the COVID-19 trials would come out of funding intended for, um, further work on Tevaly's. Could you please clarify if there were other indications beyond ITP and WAIHA that the company had intended to explore?

Manufactured large amounts of the product should ensure <unk>, we could immediately deployed it to that effect and that's a real difference over something that is in the pipeline and.

And phase one clinical study.

<unk> the the hurdles from there to actually getting two in the hands of a patient.

Dean L. Schorno: Thank you very much.

Dean L. Schorno: Yes, so let me start and then I'll ask Raul to wrap up the comments on this with any incremental thoughts. But what we've always described is that we have exclusivity with Fostamatinib-Tavalese through into 2032. And with that, with that long runway, we've always had the intention to explore incremental opportunities with this asset. We believe that, and therefore, we've always planned from a cost perspective, from an operating expense perspective, to make investments in those areas. We believe that today an optimal way to utilize resources is to, you know, explore COVID, COVID-related pneumonia, and then the extension to ARDS non-COVID that we've talked about. And so today, those are really the focus of our, at least our near-term operating expenses; we may make choices in the future to invest in Fostamatinib in other ways. But today, it's really focused on the COVID-related opportunity and then the possibility of non-COVID ARDS.

Very challenging there many hopkins for us if a doctor wants to use top of this in a patient with coke with today.

He or she could write a script and that patient with the siege Cavalese.

In a matter of hours because most hospitals have a bottle.

And if they didn't have the bother we can send them the product overnight and that patient with kept the product tomorrow. That's a real difference from okay, beltman stage product and something that is commercially available.

In addition to the as I mentioned the preclinical support is outstanding for this this opportunity. So it's clear what we would do but in the future of course will consider other things, including a rip told them or are you going to check for molecule as well we have we have those.

Okay, Yeah, no I just thought it was interesting that you could potentially pursue molecules for covered but that's absolutely.

And then.

Just wanted to ask a question about the the bgh paper.

Have a very nice swim chart, they're showing the responses invitations was the second line patient 78% response.

But I was curious about the duration of response and it looks like about half of the 32 patients maybe a little less than half had duration of response of two years, a longer which look pretty good.

Dean L. Schorno: The only thing to add there is that...

Raul R. Rodriguez: I'm like, you know. Executive vision has a very broad meaning.

Can you comment to what extent.

Raul R. Rodriguez: Not solely FC receptor signaling as it is in autoimmune diseases like AIH or ITP, though it's quite beneficial there, but it has a broader role in immune modulation in other cell types and via other mechanisms, and this COVID opportunity helps highlight that. And we'd like to take advantage of that because I think it provides us with a really useful tool. I think we've only begun to scratch the surface of the potential for sick inhibition.

I just left compare with with some of the other second line IPP therapies like the T. P O as in Rituxan statistically unto ration a response, how does it had as heavily stack up there.

Alaska.

Tarek and what's going to also contribute to us, but I think it compares nicely I think that's a very nice resolved keep in mind. The following is that.

B M and they did our studies in different places and it's always difficult to compare one study to the other another study done.

Secondly, almost a decade apart if not more and so it's charles into compare that way, but I think having that type of durability is actually quite helpful. Because if you succeed in our product and you stay on it you are likely to continue to succeed for a very long time two years is a very long time in the treatment scheme of something.

Raul R. Rodriguez: The next question comes from...

Operator: Nochomovitz of Citigroup. Please proceed with your question.

Operator: Thank you for your question.

Yigal Dov Nochomovitz: Thank you. Good evening. I guess you may have seen that Denali...

Yigal Dov Nochomovitz: , Mark Daly and Sanofi announced plans to do a COVID trial with their RIK1 inhibitor. Obviously, you have one as well.

Like I T P.

<unk>.

Sure. Thanks Raw well this is tarek and <unk> I. Appreciate the question. So one of the exciting parts of the analysis and you're actually honed on it quite acutely is actually the the other side of the coin which is.

Yigal Dov Nochomovitz: Any thought as to whether you would take R5-2 into a COVID study in addition to 2-plus-1-matinib? Skel, thank you for your question.

We see that the second line patients respond well, but frankly from a clinical perspective, it's about maintaining that response and if you look at the paper in that setting. If you use 50 K as the barometer, it's about 83% excuse and and 83 per cent and then.

Raul R. Rodriguez: You know, what's very interesting about that, it's absolutely right, and it may have potential as well in RIP inhibitors for the treatment of COVID. We are excited about Talaliz since we think the mechanism should work there. The proof-of-concept data that we shared today, not just in our hands but really in the hands of independent collaborators, is really compelling.

About 92%.

Maintain their <unk>. Their response, if you use 30 K so to get to your question though.

Raul R. Rodriguez: And it's different from other development-stage pipeline products, such as our own 552 or RIP inhibitors, in that it's approved, it's on the market, and it's commercially available today. If doctors wanted to use it, they could very well do. Even today, we've manufactured large amounts of the product so that, to our benefit, we could immediately deploy it to that effect. And that's a real difference over something that is in the pipeline and, say, in a phase one clinical study. If those work, the hurdles from there to actually getting them in the hands of a patient are very challenging. There are many.

It's kind of role was alluding to about an apples to apples comparison is you're probably familiar with unfortunately across all the different ITT trials, there's really no.

Universal definition from an endpoint design.

[noise] durability, almost every trial you come across even with the other people memetic agents, it's frankly very definition, but given that we saw upwards of 80 to 90 per cent durability based on how long these patients had been on therapy.

I can tell you is that when we presented this data in market research an advisory boards this more than exceeds expectations from clinicians because their biggest.

The biggest fear is that they're gonna take somebody out of harm's way, but it's gonna be a transient in effect.

And they have a lot of confidence based on this data because the way. The response was defined and this is it was based on number of treatment days. So however, however, long that individual patient with on fast imatinib on top of lease.

Raul R. Rodriguez: For us, if a doctor wants to use Tavalisse on a patient with COVID today, he or she could write a script, and that patient would receive Tavalisse in a matter of hours, because most hospitals have a supply. And if they didn't have the bottle, we could send them the product overnight, and that patient would get the product tomorrow. That's a real difference between a development stage product and something that is commercially available. In addition, as I mentioned, the preclinical support is outstanding for this opportunity. So it's clear what we would do, but in the future, of course, we'll consider other things, including a RIP program or even a JAKTA molecule as well. We have those.

The App is how the response rate was determined so that's a denominator there and so essentially but the thing is for the majority of time there on a product there in that really great threshold and window of response, and so that really alleviated any of those concerns about any sort of transient effect and so I can tell you the responses been pretty.

Pretty.

Positive an affirmative about this data analysis.

Okay. Thanks, and just one final question for Dean.

Theme with respect to the cash runway could you just remind us what's what's the runway is currently in.

Are you planning to access this credit facility again this year.

Yigal Dov Nochomovitz: Okay, yeah, no, I just thought it was interesting that you could potentially pursue two molecules for COVID. But that's absolutely not the case.

Thanks, you go so so we haven't given any guidance and it into the future, but let me let me answer your question in in this way. So we ended the corridor, it's about $93 million.

Yigal Dov Nochomovitz: And then, Raul, I just wanted to ask a question about the BJH paper. You know, you have a very nice swim chart there showing the responses in the patients with the second-line patients, 78 percent response. But I was curious about the duration of response. It looks like about half of the 32 patients, maybe a little less than half, had a duration of response of two years or longer, which was pretty good. Can you comment to what extent how it compares with some of the other second-line ITP therapies, like the TPOs and Rituxan, specifically on duration of response? How does that stack up there?

Cash from a topline perspective, as we look into the future. We expect you know the continued grow to.

A R. Tabriz net revenues and is all highlighted we also expect.

A in Iraq or Rip D O.

You know later later this year, which could could result in a significant milestone significant in for a cat. So so the topline in combination with the.

The cash rehab on hand is is significant for us from an operating expense perspective, we continue to expect to be able to to create your increasing leverage in the in the business from the critical programs. We've described.

As well as our sales and marketing efforts, where when we look forward to Ottoman hemolytic anemia, we expect to see people.

Raul R. Rodriguez: Good. I'll ask Tarek and

Raul R. Rodriguez: contribute to this, but I think it compares nicely. I think that's a very nice result. Keep in mind the following is that we and they did our studies in different places, and it's always difficult to compare one study to another done effectively almost a decade apart, if not more. And so it's challenging to compare that way. But I think having that type of durability is actually quite helpful, because if you succeed with our product and you stay on it, you're likely to continue to succeed for a very long time. Two years is a very long time in the treatment scheme of something like ITP.

Can't leverage no new salesforce those those types of opportunities so within that context for $93 million to $40 million available.

Our in our credit line.

And other sources of financing leave us in a solid position where today, we don't have any intent to you know to raise incremental capital that said, we will continue to your monitor our needs and opportunities and we'll make sure that the the businesses adequately funded.

Thank you thanks very much.

Sure absolutely yep. Thank you.

Chris Raymond of Piper Sandler. Please proceed with your question.

Hi, everyone. This is not coca breast cancer crashed thanks for taking the question.

Tarek Balam: Tariq, Wolfgang?

Tarek Balam: Sure, thanks Raul, this is Tarek and Yigal. We appreciate the question. So one of the exciting parts of the analysis, and you actually honed in on it quite acutely, is actually the other side of the coin, which is, you know... We see that the second line patients respond well, but frankly, from a clinical perspective, it's about maintaining that response. And if you look at the paper, in that setting, if you use 50K as the barometer, it's about 83%, excuse me, and 83%, and then about 92% maintain their response if you use 30K. So to get to your question, though, as I was kind of aluding to about an apples to apples comparison, as you're probably familiar with, unfortunately, across all the different ITP trials, there's Universal Definition from an Endpoint Design of Durability

So maybe just to start I <unk> commentary Ah so.

And a second quarter with that first quarter that Amgen sided <unk>, new patient started <unk> alternative N. I P. P. I guess does that match, but at least I T. T market change you guys got during the corner.

Is it your sense that that was checking onion part by Koga 19, the ash data update or other factors.

Sure I, unless it's hard to to come in on that and I'll add some Colorado.

Yeah I appreciate it roll and thank you Nicole for the question so I.

I would say, yes, it does sync up with our data we're seeing a decrease you know.

And played <unk> presence in the overall marketplace.

I would say causality frankly, it's something we've been tracking over time I think the coke with 19 and this is just really our impressions, Nicole, but but our impressions are essentially that's really what we've been hearing from clinicians treating this disease as well as frankly from patients and patient advocates has been the need for.

For for more flexibility and certainly having oral therapeutics adds to that to be able to.

Tarek Balam: Almost every trial you come across, even with the other Teflon mimetic agents, it's a frankly a varied definition. But given that we saw upwards of 80 to 90% durability based on how long these patients had been on therapy, what I can tell you is that when we've presented this data in market research and advisory boards, this more than exceeds expectations from clinicians, because their biggest fear is that they're going to take somebody out of harm's way, but it's going to be a transient effect. And they have a lot of confidence based on this data because the way the response was defined in this study was based on the number of treatment days. So, however long that individual patient was on fostamatinib, on Tavalese.

Being a minimal therapy, and really catered to to to to patients needs. So certainly in in the cupboard 19.

Pandemic with individuals' either sheltering in place or frankly, just trying to remove themselves from health care contact that's not necessary, having an oral option or they don't have to go in for weekly injections is certainly a benefit and these are things that we've heard from providers in our in our researching.

Discussions and dialogues so I would say, it's a trend that we saw before the pandemic and only more so accelerated during.

What did you want to add some color.

The only I'm only further color T. I don't think is that no one's these trends become normalized Oh. They go from England post pandemic world. They may very well stick and that's something though that will also continue to monitor.

Okay, Great and then maybe just isn't as a follow up I know from your your previous commentary your sales reps have had the early you're lying calories clinical data and hamsters about February can I know there's been some I guess you know transition walnut sounds there's been a lot of transition to virtual communication.

Tarek Balam: That is how the response rate was determined. So that's the denominator there. And so essentially, what it's saying is, for the majority of time they're on a product, they're in that really great threshold and window of response. And so that really alleviates any of those concerns about any sort of transient effect. And so I can tell you the response has been pretty, pretty positive and affirmative about this data analysis.

Just with the pandemic can I guess I was just curious to get your thoughts on.

My awareness fifth early airline data is still relatively low.

How's your working to remedy that.

Yigal Dov Nochomovitz: Okay, thanks. And I have just one final question for Dean.

Sure <unk>, if you don't mind I I'll jump in there again, so great question Nicole so.

You know, we previously presented and then and the other forums, Nicole we trained or we trained or Salesforce in February and and launched the data into there selling materials towards the end of Q1 and going into cue to really with the the momentum from that data.

Yigal Dov Nochomovitz: Dean, with respect to the cash runway, could you just remind us what the runway is currently and are you planning to access this credit facility again this year?

Dean L. Schorno: Thanks, Yigal. So we haven't given any guidance for the future, but let me answer your question in this way. So we ended the quarter with about $93 million in cash. From a top-line perspective, as we look into the future, we expect, you know, continued growth of our tabloids' net revenues. And as Raul highlighted, we also expect, you know, an IRAC or RIP deal later this year, which could result in a significant milestone and a significant inflow of cash. So the top line, in combination with the cash we have on hand, is important for us. From an operating expense perspective, we continue to expect to be able to create, you know, increasing leverage in the business. From the clinical programs we've described, as well as our sales and marketing efforts, where when we look forward to autoimmune hemolytic anemia, we expect to see, you know, significant leverage, no new sales force, those types of opportunities.

But the reality Nicole is the data was presented and you know obviously it and it seemed meeting at ash as a poster but.

<unk> in order for data to be disseminate as as I'm sure you will understand is.

You also hoping that third party outlets trusted source is a number of vehicles not just our own commercial efforts are picking up on that information communicating at educating it whether that you know or promotional efforts cme's et cetera, and certainly having an article now and it's in in public case.

And as a scheme does the B J H, we just see that as an accelerator if you will and so while the teams have been doing a fantastic job and I really do have to commend them on their commitment and tenacity of looking for opportunities for virtual communication with her providers.

Well can imagine without having the live medical conferences and other opportunities.

It's something that we're just progressing in building momentum and we really see this publication as an opportunity to to took to pull that forward. If you will hopefully that answers your question.

Yes, yes very helpful color. Thank you bye.

Thank you can go.

The next question is from a joke congener S. H C. Wainwright. Please proceed with your question.

Dean L. Schorno: So within that context, the $93 million, the $40 million available on our credit line and other sources of financing leave us in a solid position where today we don't have any intent to, you know, raise incremental capital. That said, we will continue to monitor our needs and opportunities, and we'll make sure that the business is adequately funded. Thank you. Thank you very much.

Good afternoon, thanks for taking the question.

Two questions or sets of questions one on U S and one in Europe, I guess, starting with the U S. I guess my question really focuses on the current patients that are mostly targeted.

You know second line patients post T. P O S et cetera. So I guess when you look at the current 54% persistency rate, which is great. I guess, how much are you looking to or your goal how much to increase that and that type of population virtuous versus how much you know bang for the Buck sorry for the pond.

Dean L. Schorno: You're welcome.

Dean L. Schorno: Thank you.

Operator: Sure. Absolutely.

Operator: Chris Raymond of Piper Sandler. Please proceed with your question. Hi, everyone. This is Nicole Gabreski on behalf of Chris.

Nicole Gabreski: Thanks for taking the question. So maybe just to start on Amgen's recent end-plate commentary. So the second quarter was the first quarter that Amgen cited slowing end-plate new patient starts due to oral alternatives and ITP. I guess, does that match the tabloid ITP market trends you guys saw during the quarter? And I guess, is it your sense that that was driven in part by COVID-19, the ASH data update, or other factors

That you can get as you're looking to expand further into the first line setting.

Oh sure. So let me I'll take make a few words in that starts to also come in on this persistency something where we monitor very carefully as you can see and.

As we launched a product and it was used primarily more of a factor in like a bit more a bit in earlier like but primarily more refractive and because they have a lower response rate naturally your persistency is going to be lower.

Tarek Balam: Sure, I'll ask Tariq to comment on that, and I'll add some color afterward.

And as we move into earlier lives Subdual benefit there's more patients there and too.

Tarek Balam: Yeah, I appreciate it, Raul. And thank you, Nicole, for the question.

Response rates are higher substantially higher is your song towards slug, and we expect as the results of that persistency to continue to turned up for Ya.

Tarek Balam: So, I would say, yes, it does sync up with our data. We're seeing a decrease in end-plate presence in the overall marketplace. I would say causality, frankly, is something we've been tracking over time. I think COVID-19, and this is just really our impressions, Nicole, but our impressions are essentially that really what we've been hearing from clinicians treating this disease, as well as, frankly, from patients and patient advocates, has been the need for more flexibility, and certainly having oral therapeutics adds to that, to be able to be an amenable therapy So, certainly, in the COVID-19 pandemic, with individuals either sheltering in place or, frankly, just trying to remove themselves from healthcare contact, that's not necessary. Having an oral option where they don't have to go in for weekly injections is certainly a benefit. And these are things that we've heard from providers in our research and in our discussions and dialogues. So, I would say it's a trend that we saw before the pandemic and only more so accelerated during it.

Sure.

Yeah.

Thank you covered a lot of the key points their role. So so Joe I you know I don't think we're really giving guidance right now in the sense of what our aspirational persistency rates are we believe that there's improvement as patients and frankly practitioners become more familiar with a product we know that the prognosis of patients.

As you articulated you know as we move it up we know these patients R. R. R or frankly, they have a better prognosis they potentially have less comorbid conditions earlier in the stage of the disease and we believe the patient's can overall have a better I'll come on our product represented not only by our own data analysis, but frankly, just even and.

Totally from talking to clinicians and so.

As we move whether it's you know from patients from third lines, a second line or just earlier into care.

Those individual physicians, we're hearing on a case by case.

Experience that physicians are finding greater utility for the product.

Got it no. That's helpful. Thank you and then my my Y-you question, I know things or early right now with regard to the launch that griff oldest conducting but I guess, maybe two parts number one can you highlight sort of the blocking tackling that needs to go what are the types of hurdles that you would see obviously from a geographical standpoint is it more of just.

Raul R. Rodriguez: Raul?

Tarek Balam: The only further color to add, I think, is that once these trends become normalized, even in the post-pandemic world, they may very well stick. And that's something that we'll also continue to monitor.

You know reimbursement in particular geographical areas or just the variability of types of treatments and geographical areas or a combination of both number one and then the second part is maybe for Dean are you guys Gonna look to eventually break out the royalty streams versus the actual revenues.

Nicole Gabreski: Okay, great. And then maybe just as a follow-up, I know from your previous commentary that your sales reps have had the earlier line Tavilis clinical data in hand since about a year ago.

And the piano.

Oh, sorry, one or two make some comments on on the European lunch.

Tarek Balam: And I know there's been some, I guess, you know, transition, well, not some, there's been a lot of transition to virtual communication just with the pandemic, but I guess I was just curious to get your thoughts on, you know, why awareness of this earlier line data is still relatively low, and how you're working towards that. Raul, if you don't mind, I'll jump in there again.

And then sure let's see.

He is sure and then I'll hand, it off to to Dean's perfect and another all will feel free to add any color. So joke great question and.

Not surprising because it's obviously exciting news for us to to now have a global footprint and frankly to know that our product is providing benefits of patients outside of the U S. Essentially to say you know across the globe. So that's that's you know obviously a fantastic milestone that we're very very proud up.

It is early days so it it is premature to kind of sure any sort of.

[noise] comes yet it's it's it's only been a few weeks since Germany in the U K started treating patients, but you know from from from the strong collaboration that we have with <unk>. You know obviously, we see this is a huge opportunity as you're well aware you know it represents almost $900 million market opportunity.

Tarek Balam: So, great question, Nicole. So, as you know, we previously presented in other forums. Nicole, you know, we trained our Salesforce in February and launched the data into their selling materials towards the end of Q1 and going into Q2, really with the momentum from that data. But the reality, Nicole, is the data was presented and, you know, obviously, at an esteemed meeting at ASH as a poster. But, you know, in order for data to be disseminated, as I'm sure you well understand, you're also hoping that third-party outlets, trusted sources, a number of vehicles, not just our own commercial efforts are picking up on that information, communicating it, educating it, whether that And certainly, having an article now in a publication as esteemed as the BJH, we just see that as an accelerator, if you will.

As far as the hurdles.

Again, I think you know they're facing the cupboard pandemic just like we are they're they're they're they're launching in the midst of this I can tell you they've been very committed to their virtual engagements and frankly, we've been very impressed with their executioner plans to get the word out and they they they have serendipity on their hands in the sense that there.

There timing of the lunch does coincide with the availability of the second line data analysis, and so they're able to provide you.

Assuming it's permissible in their marketplace to provide all the information that's part of the comprehensive story or <unk> or tub lesson that market.

That we have here in the U S. Today, So I Wanna make sure I covered all the aspects of your question was was there anything else that you'd specific last oriented over to dean.

You really address that I guess the other thing is you know I guess you have a.

Tarek Balam: And so, while the teams have been doing a fantastic job, and I really do have to commend them on their commitment and tenacity in looking for opportunities for virtual communication with our providers, as you can imagine, without having the live medical conferences and other opportunities, it's something that we're just progressing with and building momentum. And we really see this publication as an opportunity to pull that forward, if you will. Hopefully, that answers the question, Yeah, yes, a very helpful color. Thank you.

Country by country reimbursement aspect too that's gonna be part of the the blocking in tackling sort of a tour of course Yep I forget the absolutely yeah. Okay, great. Thank you.

How did you say you realize that in Europe.

The launches happens in different countries and different sequences. It doesn't all happen at once I get those here in the U S. So you'll see.

France, Italy, Spain other countries come in some order depending on how quickly those negotiations take place.

Alright, and with with respect to their reporting Joe.

Tarek Balam: Thank you, Yigal.

Joseph Pantginis: The next question is from Joe Pantginis of H.C. Wainwright. Please proceed with your question. Hey guys, good afternoon.

<unk> the lunch Jalan should happen and therefore, rehabbing, we haven't determine exactly how will provide teller in detail on on breaking that out and specifically reported in it I would remind remind everyone that in the 20 million dollar.

Joseph Pantginis: Thanks for taking the question. Two questions or sets of questions, one on the U.S. and one in Europe. Starting with the U.S., I guess my question really focuses on the current patients that are mostly targeted, you know, second-line patients, post-TPOs, etc. So, I guess when you look at the current 54 percent persistency rate, which is great, I guess how much are you looking to, or your goal, how much to increase that in that type of population? Versus how much, you know, bang for the buck, sorry for the pun, that you can get as you're looking to expand further into the first-line setting?

Milestone payment, we got in Q1 $2.5 million, if not milestone wasn't advanced royalty payments. So so we've already been paid and even if even recognized at $2.5 million of the first tranche of royalty payments will receive from bristles, let's stay tuned as as Gribbles starts.

Starts to know salad won't will provide you with no clarity in detail around that.

Revenue source and those revenues.

Got it thank you guys.

Raul R. Rodriguez: So let me make a few words and ask Tarek to also comment on this. Persistency is something we monitor very carefully, as you can see. And, you know, as we launched the product, it was used primarily in more refractory lines, a bit in earlier lines, but primarily more refractory. And because they have a lower response rate, naturally, your persistency is going to be lower. And as we move into earlier lives, it has the dual benefit of there being more patients there.

Thank you.

The next question is from do Kim a BMO capital markets. Please proceed with your question.

Hey, you're good afternoon <unk>. This is D. K on for do first and foremost congratulations on the quarter for increase in sequential quote unquote ourselves their beliefs.

My question is about to have at least but more so for in terms of way Huh. No. You mentioned, that's a little bit too early to definitely say what the time lines are given the coldest situation, but is it possible to kind of give us a better sense like maybe a base case worst case scenario here.

Here, we simply you know taking all the additional months or lost while the Roman was suspended or do we have to account for potential ramp up for each site.

Raul R. Rodriguez: And two, the response rates are higher, substantially higher, as you saw in Tarek's slide. And we expected the results of that persistency to continue to trend upward.

Can I get operations going again before.

They're actually up and fully enrolling patience about a little more color on that would be helpful for us.

Tarek Balam: Tarek?

Tarek Balam: Yeah, I think you covered a lot of the key points there, Raul. So, Joe, you know, I don't think we're really giving guidance right now in the sense of what our aspirational persistency rates are. We believe that there will be improvements as patients and, frankly, practitioners become more familiar with the product. We know that the prognosis of patients, as you articulated, as we move it up, we know these patients are, frankly, they have a better prognosis. They potentially have fewer comorbid conditions earlier in the stage of the disease.

Sure I'll ask what's going to make a few comments on that.

Yeah. Thanks for the Christian first of all let me reassure that we have a great team in place.

Both of the Rigel F. L. S C R O.

[noise] hurts, we have some 90 site open now to contribute to be additional 45 patients that'd be neat.

Sent to your point, we all still independent make and hour clinical trials sorry, it's just like any other clinical practice do needs to work around social distancing you know avoiding cool with 19 infections and focus in severe cases and things like that but since technically we only need one new patient from hassle.

Tarek Balam: And we believe patients can overall have a better outcome with our product, as represented not only by our own data analysis but, frankly, just even anecdotally from talking to clinicians. And so, as we move, whether it's from patients from third line to second line or just earlier into care with those individual physicians, we're hearing on a case-by-case basis that physicians are finding greater utility for the product. Got it. No, that's helpful. Thank you.

The site, we're still very optimistic booming can pick up suddenly and rather rapidly.

But you know I I I I Wanna stay away from giving you a precise date other other than the reassuring you and giving you a those those encouraging correct.

Okay, that's where thanks for that clarification and this is not going to have any type of applications on the data integrity correct.

Joseph Pantginis: And then my EU question. I know things are early right now with regard to the launch that Griffold is conducting, but I guess there could be two parts. Number one, can you highlight sort of the blocking and tackling that needs to go? What are the types of hurdles that you would see, obviously, from a geographical standpoint? Is it more of just, you know, reimbursement in particular geographical areas or just the variability of types of treatments in geographical areas or a combination of both? Number one. And then the second part is maybe for Dean, are you guys going to look to eventually break up?

Yeah, No I'm I'm very happy to.

To tell you that we immediately with the shut down we had a laser sharp focus on the potential of missing data or or or a bad quality data and and we were able to have the amount of missing data fluid the patient's that'd be already have two O two a really small minimum.

So this when two extra better than than I was originally I'm afraid of.

Okay. Good deal and my last question has to do with a pipeline.

Is there a potential where.

Joseph Pantginis: Royalty streams versus the actual revenues in the P&L. Tariq, why don't you make some comments on the European launch?

You take the Iraq, one four inhibitor and.

Develop a little bit further to get better economics on a deal Copro and a coke development deal.

Tarek Balam: Sure. Sure. And then I'll hand it off to Dean. Perfect. And, Raul, feel free to add any color. So, Joe, great question.

As opposed to license and get out at the end of the year and in addition to that what type of indications have you discussed with your partner or just what you've been thinking about in terms of pursuing Ah for this type of deal.

Tarek Balam: Not surprising because it's obviously exciting news for us to now have a global footprint and, frankly, to know that our product is providing benefits to patients outside of the U.S., essentially to say, you know, across the globe. So that's, you know, obviously a fantastic milestone that we're very, very proud of. But it is early days. So, you know, it is premature to kind of share any sort of, you know, outcomes yet.

Okay I'll take what all is sugar sure absolutely I'll answer that.

Absolutely in fact, almost likely will partner, one and not the other we're pursuing boats.

My partner, both that's what we.

Sorry, but but we're confident will be able to put a partnership in place and that partnership will achieve some very important goals. One is to bring substantial amount of resources economic clinical resources that a large farm a partner has to bring to bear on these both opportunities because they both have tremendous.

<unk> and a wide range of areas.

Big areas like dog rheumatoid arthritis for example.

Psoriasis small areas as well in some cases like a L. S.

Tarek Balam: It's only been a few weeks since Germany and the U.K. started treating patients, but, you know, from the strong collaboration that we have with Griffiths, obviously, we see this as a huge opportunity. As you know, it represents almost $900 million in market opportunity. As far as the hurdles, again, I think, you know, they're facing the COVID pandemic just like we are. They're launching in the midst of this, and I can tell you they've been very committed to their virtual engagements. And frankly, we've been very impressed with their executional plans to get the word out. And they have serendipity on their hands in the sense that their timing of the launch does coincide with the availability of the second line data analysis.

And so we're interested in bringing to bear that level of commitment in a partner.

Because the opportunities are really quite sizable.

But we want to also be able to share in that and contributed Ensco development and we think that with with our commercial lessons. We can contribute to the commercialization of these products and certain aspects in in certain circumstances, and we're going to model that with those appointments and so we think it's.

<unk> proposal for them, obviously, they're trying to proposal for us a beyond those features obviously the economics are very useful in and we think that we can get a very attractive economic deal done as well and so we look forward to putting that in place it could well be that we decided that we put the one of each too and the.

Otherwise you suggest it may take it forward ourselves to the next stage and partner. It then.

Joseph Pantginis: And so they're able to provide, you know, assuming it's permissible in their marketplace, all the information that's part of the comprehensive story of Tavelis or Taveles in that market that we have here in the U.S. today. So I want to make sure I covered all the aspects of your question. Was there anything else that you would specifically ask before I hand it over to Dean? No, you really addressed it. I guess the other thing is, you know, I guess you have a country-by-country reimbursement aspect, too, that's going to be part of the blocking, sort of rhetorical.

And then continued to add value that is very much a possibility.

And and and we do that but it's on the basis of having done a very attractive deal with we decided to go that route.

But the opportunities are so large frankly, having more muscle more resources is very helpful.

Okay. Thank you for the additional color and congrats with you on the corner.

Thank you so much.

The next question is from Tessa Romero of J P. Morgan. Please proceed what's your question.

[noise], Hey, guys. Good afternoon, and thank you for taking my question and congratulations for me as well on the progress. This corner just just the one I'm covered 19 impact for the corner of French heavily we're trying to get a better understanding I've been dynamics that you saw with respect recently.

Joseph Pantginis: Of course,

Joseph Pantginis: Yeah, yeah, absolutely, yeah.

Joseph Pantginis: Okay, great, thank you.

Joseph Pantginis: And you may realize that in Europe.

Raul R. Rodriguez: The launch happens in different countries in different sequences. It doesn't all happen at once like it does here in the U.S. So you'll see France, Italy, Spain, and other countries come in in some order, depending on how quickly those negotiations take place.

Nurses sequential patient match, so anything with no dancing, a corner and maybe awesome into July I can do you think about aren't very <unk>. Thanks, so much eyes.

Dean L. Schorno: With respect to the reporting, Joe, the launch just happened, and therefore, we haven't determined exactly how we'll provide color and detail on breaking that out and specifically reporting it. I would remind everyone that in the $20 million milestone payment we got in Q1, $2.5 million of that milestone was an advanced royalty payment. So we've already been

Sure well, let's talk to come in on refill the new patients starts with a <unk> coke commercial.

Sure. Thanks trouble. So I appreciate the question Tessa as you can imagine.

This was an area for us that we were highly concerned about like any organization going into the shelter in place, but I think you know as we just kind of commented earlier about even just frankly, the discussions in regards to injectable versus orange and having advantages there.

Unknown Executive: Unknown Executive, Yigal Nochomovitz, Raul Rodriguez, Dean Schorno, Kalpit Patel, Carly Kenselaar, Raymond Furey, Richard Miller, Raymond Furey, Unknown Executive, Eun Yang, Nalin Tejavibulya

Our clinicians very much quickly adapted to a teller medicine and supporting their patients remotely I think the fact that our patients have have tolerated the drug they've they've.

Joseph Pantginis: Thank you, guys.

Operator: Thank you, guys. Thank you. The next question is from Du Kim of BMO Capital Markets. Please proceed with your question.

<unk> that are currently utilizing the products are familiar with a product.

Operator: Hey, good afternoon guys. This is EK on for Doe.

EK: First and foremost, congratulations. Quarter for increasing the sequential quarter-over-quarter sales there for Tavolisse. My question is about Tavolisse, but more so in terms of WEHA, I know you mentioned that it's a little bit too early to definitively say what the timelines are given the COVID situation, but is it possible to kind of give us a better sense, like maybe a base case, worst case scenario here? Are we simply tacking on additional months that were lost while enrollment was suspended, or do we have to account for a potential ramp-up for each site just to kind of get operations going again before they're actually up and fully enrolling patients? A little more color on that would be helpful for us.

You know without getting into the specifics of of the numbers I would say that we were actually very very pleasantly surprised from an operational aspect how not only were they able to.

Maintain and and frankly be able to manage their patients currently on top of Leafs remotely.

But but more importantly, and I think we talked about this in a previous court or is there anything call.

The patience.

We're also looking for other options, particularly if they were on an injectable or <unk> or needing an alternative therapy and physicians, we're comfortable in this remote environment, especially given our value proposition to identify new patients and switch them to an alternative oral therapy until I I think frankly.

Raul R. Rodriguez: Sure, I'll ask Wolfgang to make a few comments on that.

Speaking or value prop has actually served as quite well.

Wolfgang Dummer: Yeah, thanks for the question. First of all, let me reassure you that we have a great team in place, both at Rigel as well as at our CRO. As you have heard, we have 90 sites open now to contribute the additional 45 patients that we need. That said, to your point, we are still in a pandemic, and our clinical trial sites, just like any other clinical practice, do need to work around social distancing, you know, avoiding COVID-19 infections and focus on severe cases and things like that. But since technically we only need one new patient from half of the sites, we are still very optimistic that enrollment can pick up suddenly and rather rapidly. But, you know, I want to stay away from giving you a precise date other than reassuring you and giving you those encouraging facts.

During this pandemic not to say that were capitalizing on this but Ah to say that physicians are seeing value physicians are seeing opportunity and our receptive to our messaging.

The only thing to add their Tessa this as well as well both I T. P. M. This applies to it says well very serious conditions and what pieces are have some hesitation to go see a doctor.

All the time is things become more normal like that is just continues on for months. They do need additional therapies. When I'm. There platelet counts are very low or frankly, they're hemoglobin levels are very long vacation, hey, IHA and they do go off and seek seek new new treatments.

And it's good that <unk> with the second line data can be part of that discussion and and I think for some patients maybe there will be the right the right age.

Okay, great. Thank you for taking our question.

EK: Okay, that's fair. Thanks for that clarification. And this is not going to have any type of implications on data integrity, correct?

Thank you <unk>.

The next question is from Christian cluster of Cantor Fitzgerald. Please proceed with your question.

Hi, everyone thinks for taking my question didn't congrats on a very productive korner.

Wolfgang Dummer: Yeah, no, I'm very happy to tell you that immediately, with the shutdown, we had a laser-sharp focus on the potential for missing data or bad quality data, and we were able to reduce the amount of missing data for the patients that we already have to a really small minimum. So this went actually better than I originally thought it would.

So you discuss the importance of tracking the duration of response for Cavalese from the British Journal Hematology publication, and I wanted to touch on the other side of that on the on set or time to initial effect. So I know you've commented before that real life experience has been different than what was it there have been child.

So are you starting to see any trend or hypothesised why some patients responds quickly, whereas other speak longer and then on that no. How does your sales team market. This to make sure physician with their giving cavalese, a real shop before discontinuing it not seeing any effect.

EK: Okay, good deal. And my last question has to do with the pipeline. Is there a potential where we take the IRAC1.4 inhibitor and develop it a little bit further to get better economics on a deal, a co-pro and a co-development deal, as opposed to licensing it out at the end of the year? And in addition to that, what type of indications have you discussed with your partner or just what you've been thinking about in terms of pursuing this?

Sure.

Alright.

Thank you for sure [laughter], Thanks, sorry, <unk> I didn't mean to step all over you there.

But what I would say is feel free to add color of walking on the clinical aspects I can talk about the salesforce as well. It's R. Physician response, and so you're absolutely spot on Christian which is you know.

Raul R. Rodriguez: I'll answer that. Sure, absolutely. I'll answer that.

Raul R. Rodriguez: You know, it's absolutely, in fact, almost likely that we'll partner with one and not the other. We're pursuing both. We might partner both. That's what we say, but we're confident we'll be able to put a partnership in place, and that partnership will achieve some very important goals. One is to bring a substantial amount of economic and clinical resources that a large pharma partner has to bring to bear on these two opportunities because they both have tremendous opportunities in a wide range of areas. Big areas like rheumatoid arthritis, for example, psoriasis, and small areas as well, in some cases like ALS. And so we're interested in bringing that level of commitment to bear on a partner because the opportunities are really quite sizable, but we want to also be able to share in that and contribute to ENDSCO's development.

In our initial clinical trials.

And our fit one to two programs we presented it we publish it even prior to the second line, we've talked about the medium time to first response was 15 and a half days, but we've also previously talked about you know there is variability you know that was a clinical trial versus real world. There's there's all sorts of things that happen in the rural.

Setting that clinicians and patients have to pace I think what benefit heard us to be to be honest from a messaging as well as a learning in education platform is that early on in the launch we started hearing from clinicians about some of these varied responses and and if you look at the product label.

[noise] endorses and supports giving patients at least three months to adjudicate or or reconcile. If this patient has had a <unk>, having an adequate response and giving the heterogeneity of this disease. The heterogeneity of response to our agent as well as other agents out there in the marketplace.

And really I think the guidelines speak to this which is about the customization of cheap treatment approach are salesforce was able to utilize that language in a product insert from our clinical trial experience to both sure the potential upside and benefit that there are some patients that are gonna have or a rapid response.

Raul R. Rodriguez: And we think that with our commercial effort, we can contribute to the commercialization of these products in certain aspects, in certain circumstances, and we're going to model that with those partners. And so we think it's an attractive proposal for them, obviously a very attractive proposal for us. Beyond those features, obviously, the economics are very useful, and we think that we can get a very attractive economic deal done as well. And so we look forward to putting that in place. It could well be that we partner one of these two, and the other, as you suggest, we may take it forward ourselves to the next stage and partner it then, and then continue to add value. That is very much a possibility. And we will do that, but it's on the basis of having done a very attractive deal if we decide to go that route. But the opportunities are so large that, frankly, having more muscle and more resources is very helpful.

That consistent with our label consistent with our finding you really need to give the patient's the best shop possible, having a good I'll come on the on the product and really meeting those goals upstairs.

That's a physician's identified and at the patient's identified because it varies amongst physicians in patient.

One physician might be satisfied with a platelet level of going from 10000 to 25000, and whereas another physician may want it to get to 35000, and I think that variability really speaks to the customization of treating the patient in front of you and so given that full three months. A response as described to buy R. P. I I.

Think really helps us drive that notion drive that messaging in education that you need to give the product a chance to meet your objectives.

So does that answer your question Kristin.

Yeah. It's very helpful. Thank you and if I may ask a follow up related to the coven 19th study.

EK: Okay, thank you for the additional color and congrats on being on the call.

So the first part of the question is just based off of the standard of care. You know obviously this is ed and new indication that everyone's trying to understand and I know you with dexamethasone as a potential for wine, but given that your lead investigator you know as I know had presented some of your revolting I T P and he's a very knowledgeable about.

Operator: Thank you so much. The next question...

Operator: The next question is from Tessa Romero of J.P. Morgan. Please proceed with your question.

Tessa Romero: Hey guys, good afternoon, and thank you for taking my question and congratulations for me as well on the progress this quarter. Just one on COVID-19 impact for the quarter for Tavilis, we're trying to get a better understanding of the dynamics that you saw with respect to refill rate versus sequential patient ads. So anything you would note there for the quarter and maybe also into July as we think about our third quarter estimates. Thanks so much, guys.

<unk> do you think that there are any therapies in general that are being studied for Kobe that have the best shot D U as a combination with US Tonight and then.

Sure I'm going to ask what's going to make Thomas on that and on standard of care.

Yeah. So in general we have to allow the combination with standard of care. If there is compelling data to suggest that a drug Brooks otherwise you know physicians would smell participate in your trial.

Raul R. Rodriguez: Sure. I'll ask Tariq to comment on the refill when the new patient starts with the Tavalisin COVID commercial.

That's it for example, if you look at that takes a mess us on data more closely.

Tarek Balam: Sure, thanks, Raul. I appreciate the question, Tessa.

Data is not pet is not that earthshaking. So there is some some some benefit in particular for the most of your patient and quite sure given the the cheap price and this existing data. Many physicians will want to use tomatoes on in the background, but I think there's still a lot of room to grow.

Tarek Balam: As you can imagine, you know, this was an area for us that we were highly concerned about, like any organization going into the shelter-in-place. But I think, you know, as we just kind of commented earlier about even just, frankly, the discussions about injectable versus orals and having advantages there, our clinicians have very much quickly adapted to telemedicine and supporting their patients remotely. I think the fact that our patients have tolerated the drug means that the offices that are currently utilizing the product are familiar with it. You know, without getting into the specifics of the numbers, I would say that we were actually very pleasantly surprised from an operational aspect how not only were they able to maintain and, frankly, be able to manage their patients currently on tablilis remotely, but more importantly, and I think we talked about this in the previous quarters.

To accomplish much where they fix hasn't been <unk>, what do we have seen so far.

The other the other drug tests emergency approved of isn't always is when there's a beer.

You have a similar comment on this I think the the the the mechanism of action in the patients who are already hospitalized is not.

A strong is is not as strong as a rationale because I've I've shown you that you get this really severe cases, mostly windows viral load is already on the on the downturn in and it seemed noon system that causes the severe cases, so reduction of viral loads may not be all that beneficial in that in the sitting that's it again.

If you say on top of standard of care. It's an institution says this is all the standard of care, we will allow it but we will but we still do see a lot of upset for first time of milk.

Tarek Balam: These patients were also looking for other options, particularly if they were on an injectable or needed an alternative therapy. And physicians were comfortable in this remote environment, especially given our value proposition to identify new patients and switch them to an alternative oral therapy. And so I think, frankly speaking, our value proposition has actually served us quite well during this pandemic, not to say that we're capitalizing on this, but to say that physicians are seeing value, physicians are seeing opportunity, and are receptive to our messaging.

Oh hope that helps.

Yeah. Thank you and then just quickly on that Fry I know that this study's of course much shorter than the childhood, you're you know primarily used to running but can you talk about the rationale so just to utilize them to be 150 milligram dose here.

Yeah, as you know and I T. P. We advise to start on 100 milligrams and then after four weeks at the description of the P. I you can increase that those to 150. So that is what we have in the labor now we have used up to.

200 in in C N L trials and connect lymphatic lymphoma.

Raul R. Rodriguez: The only thing to add there, Tessa, this is Raul, is, you know, both ITP, and this applies to AIHA as well, very serious conditions. And while patients have some hesitation to go see a doctor all the time, as things become more normalized, that is, this continues on for months, they do need additional therapy when their platelet counts are very low or, frankly, their hemoglobin levels are very low, in the case of AIHA. And they do go out and seek new treatments. And it's good that Tavalisse, with its second-line data, can be part of that discussion. And I think for some patients, Maybair will be the right agent.

So.

Given given that you will treat those patients in a very severe condition for two weeks, maybe up to four weeks you don't want to yeah. It. It does that is too low.

And start with with a higher those also these patients I'll hospitalized under supervision and all these things, so which alleviates any any type of concerns.

And we don't Wanna go to the 200, because the again the 150 is the currently labels dose and and is the higher social for Tuesday, generally using and they're probably going with the hundred and 50.

Raul R. Rodriguez: Okay, great. Thank you for taking our questions. Thank you, Tristan.

Okay, great. Thank you. So much appreciate you taking my question.

Thank you Christian.

There are no further questions at this time I would like to turn the four back over to Mister <unk> Rodriguez for closing comments.

Tessa Romero: Thank you, Tessa.

Operator: The next question is from Kristen Kluska of Cantor Fitzgerald. Please proceed with your question. Hi, everyone.

Thank you everyone I'd like to thank you for your for listening I'd like to thank you for your support.

And your help we have some incredible opportunities ahead of us some of the area that we're looking at right now I think we'll add tremendous value and in the short term. So thank you for your support and allowing us to do that we'll keep you informed up further updates in coming months take care of and stay sick.

Kristen Brianne Kluska: Thanks for taking my questions, and congrats on a very productive quarter. So, you discussed the importance of tracking the duration of response for Tavalese from the British Journal of Hematology publication, and I wanted to touch on the other side of that, on the onset or time to initial effect. So, I know you've commented before that real-life experience has been different than what was observed in trials. So, are you starting to see any trends or hypothesize why some patients respond quickly, whereas others take longer? And then, on that note, how does your sales team market this to make sure physicians are giving Tavalese a real shot before discontinuing it if they are not seeing any effect?

This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.

[music].

Tarek Balam: That's it.

Tarek Balam: Thanks. Sorry, Raul. I didn't mean to step all over you there.

Tarek Balam: But what I would say is, feel free to add color or Wolfgang on the clinical aspects. I can talk about the sales force as well as our physician response. And so you're absolutely spot on, Kristen, which is that in our initial clinical trials, in our FIT I and FIT II programs, we presented it, we published it even prior to the second line. We talked about the median time to first response being 15 and a half days.

Tarek Balam: But we've also previously talked about variability. That was a clinical trial versus the real world. There are all sorts of things that happen in the real world setting that clinicians and patients have to face. I think what benefited us, to be honest, from a messaging platform as well as a learning and education platform is that early on in the launch, we started hearing from clinicians about some of these varied responses. And if you look at the product label, it actually endorses and supports giving patients at least three months to adjudicate or reconcile if this patient is having an adequate response. And given the heterogeneity of this disease, the heterogeneity of response to our agent as well as other agents out there in the marketplace, and really, I think the guidelines speak to this, which is about the customization of treatment.

Tarek Balam: Our sales force was able to utilize that language in the product insert from our clinical trial experience to both share the potential upside and benefit that there are some patients that are going to have a rapid response but, consistent with our label, consistent with our findings, you really need to give the patients the best shot possible at having a good outcome on the product and really meeting those goals of therapy that the physicians identified and that the patients identified because it varies amongst physicians and patients. You know, one physician might be satisfied with a platelet level going from 10,000 to 25,000, whereas another physician may want it to get to 35,000. And I think that variability really speaks to the customization of treating the patient in front of you. And so given that full three months of response as ascribed to by our PI, I think it really helps us drive that notion, drive that messaging, and education that you need to give the product a chance to meet your objectives. So does that answer your question, Kristen? Yes, it was very helpful. Thank you.

[music].

Kristen Brianne Kluska: And if I may ask a follow-up related to the COVID-19 study. So, the first part of the question is just based on the standard of care. You know, obviously, this is a new indication that everyone's trying to understand, and I know you list dexamethasone as a potential for one. But given that your lead investigator, you know, as I know, has presented some of your results in ITP and is very knowledgeable about the drug, do you think that there are any other therapies in general that are being studied for COVID that have the best shot to be used as a combination with

Wolfgang Dummer: Sure. Why don't we ask Wolfgang to make a...

Wolfgang Dummer: Thank you for that.

Wolfgang Dummer: Yeah, so in general, we have to allow the combination with standard of care if there is compelling data to suggest that a drug works. Otherwise, you know, physicians would just not participate in your trial.

Wolfgang Dummer: That said, for example, if you look at the dexamethasone data more closely, the data is not that earth shaking. So there is some benefit, in particular for the more severe patients. And quite sure, given the cheap price and this existing data, many physicians will want to use dexamethasone in the background. But I think there's still a lot of room to grow to accomplish much better effect sizes than what we have seen so far. The other drug that's emergency approved, as you know, is remdesivir. I have a similar comment on this.

Wolfgang Dummer: I think the mechanism of action in the patients who are already hospitalized is not as strong as a rationale because I've shown you that you get these really severe cases, mostly when your viral load is already on the downturn, and then it's the immune system that causes the severe cases. So reduction of viral load may not be all that beneficial in that setting. That said, again, if you say on top of the standard of care, if an institution says this is our standard of care, we will allow it. But we will try. But we still do see a lot of upside for them. I hope that that helps.

Wolfgang Dummer: And then just quickly on that front, I know that this study is, of course, much shorter than the trials you're primarily used to running, but could you talk about the rationale for just using the 150 milligram dose here?

Wolfgang Dummer: Yeah, as you know, in ITP, we advise starting at 100 milligrams, and then after four weeks, at the discretion of the PI, you can increase the dose to 150. So that is what we have on the label.

Wolfgang Dummer: Now we have used up to 200 in CLL trials and chronic lymphatic lymphoma. So given that you will treat those patients in a very severe condition for two weeks, maybe up to four weeks, you don't want to err on the dose that is too low and start with a higher dose. Also, these patients are hospitalized under supervision and all these things, which alleviates any type of concerns. And we don't want to go to the 200 because, again, the 150 is the currently labeled dose, and it's the higher dose of the two that we're generally using, and therefore, we're going with the 150.

Kristen Brianne Kluska: Okay, great. Thank you so much. I appreciate you taking the time to answer my questions.

Kristen Brianne Kluska: Thank you, Kristen.

Raul R. Rodriguez: There are no further questions at this time. I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.

Operator: Thank you, everyone. I'd like to thank you for your for listening. I'd like to thank you for your support and your help. We have some incredible opportunities ahead of us. Some of the areas that we're working on right now I think will add tremendous value in the short term. And so, thank you for your support in allowing us to do that. We'll keep you informed of further updates in the coming months. Take care and stay safe.

Operator: This concludes.

Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Operator: BF-WATCH TV 2021