Q1 2021 Rigel Pharmaceuticals Inc Earnings Call

Greetings and welcome to Rigel Pharmaceuticals Financial conference call for the first quarter till 2021 at this time all participants are in a listen only mode. A brief question and answer session will follow the presentation.

Operator: Greetings and welcome to Rigel Pharmaceuticals' financial conference call for the first quarter of 2021. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the phone presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

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

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. Vance. You may begin.

As a reminder, this conference is being recorded it is now my pleasure to introduce our first speaker day.

All the Vince, whose Rogers executive Vice President Corporate Affairs, and General Counsel. Thank you Ms. Vance you may begin.

Welcome to our first quarter 2021 financial results and business update conference call the.

Dolly Vance: Welcome to our first quarter.

Dolly Vance: 2021 Financial Results and Business Update Conference Call. The financial press release for the first quarter was issued.

The financial press release for the first quarter was issued a short while ago and can be viewed along with the accompanying slides for this presentation and the news and events section of our Investor Relations page on our website at Www Dot Rigel Dot com.

Dolly Vance: [inaudible]

Dolly Vance: 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 that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC, including our Q1 quarterly report on Form 10-Q on file with the SEC.

As a reminder, during today's call we may make forward looking statements regarding our financial outlook, and our plans and timing of it for regulatory and product development.

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted a description of these risks can be found in our most recent annual report on form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC, including our Q1 quarterly report on form.

10-Q on file with the SEC.

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

Dolly Vance: Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements.

Dolly Vance: 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. Thank you, Dolly, and thank you to everyone for joining us on our first quarter 2021 conference call. Also with me today are Wolfgang Dummer, our Chief Medical Officer; Dave Santos, our Chief Commercial Officer; and Dean Schorno, our CFO.

At this time I would like to turn the call over to our CEO Raul Rodriguez.

Thank you Dolly and thank you to everyone for joining us on our first quarter 2021 Conference call also with me today are Wolfgang Dummer, our Chief Medical Officer.

Santos, our chief commercial officer, and Dean shortening our CFO.

Beginning on slide five the for.

Raul R. Rodriguez: Beginning on slide five, the first quarter was a quarter of progress for Rigel across several of our key value drivers, as you see on this page. We saw both continued challenges and opportunities created by the COVID-19 pandemic, and we'll discuss this during our call. In ITP, we continue to see year-over-year growth in bottles shipped to patients and clinics, but a decline in comparison to a strong Q4 in 2020. This is consistent to what we have seen with all the competitors in the TIPO class, all of which had sales declines in Q1 relative to Q4.

First quarter was a quarter of progress for rigel across several of our key value drivers as you see on this page. We saw both continued challenges and opportunities created by the COVID-19 pandemic and we'll discuss this during our call.

And I T. P. We continued to see year over year growth of bottles shipped to patients from clinics, but a decline in comparison to a strong Q4 in 2020.

This is consistent to what we have seen with all the competitors in the Tipo class all of which had sales decline in Q1 relative to Q4.

In addition, and as Dean and Dave will describe in detail decreases in bottles remaining in our distribution channels for inventory significantly impacted our sales during the quarter.

Raul R. Rodriguez: In addition, as Dean and Dave will describe in detail, decreases in bottles remaining in our distribution channels or in inventory significantly impacted our sales during the quarter. They will also describe how we are increasing our promotional efforts to drive growth in the back half of the year as the effect of vaccines allows increased access to physicians and new opportunities for physicians and patients to switch therapies. We also made important progress in our warm autoimmune hemolytic anemia. Wolfgang will describe the recent increase in enrollment.

Steve will also describe how we are increasing our promotional efforts to drive growth in the back half of the year as the effect of vaccines allow increased access to physicians and new opportunities for physicians and patients to switch therapies.

Yeah.

We also made important progress in our warm autoimmune hemolytic anemia.

Whats King will describe the recent increase in the enrollment we now have 72 of our targeted 90 patients enrolled.

Raul R. Rodriguez: We now have 72 of our targeted 90 patients enrolled, only 18 to go. And we look forward to further acceleration as vaccine availability improves. This enrollment progress puts us closer to our goal to be the first approved product for the treatment of warm autoimmune hemolytic anemia and, therefore, to capture a substantial share of this very significant market opportunity. Our comprehensive COVID clinical program is advancing on multiple fronts. And, as we described in some detail a couple weeks ago, we reported positive top-line results from our Phase 2 clinical trial conducted in collaboration with the NIH and Inova. Wolfgang will provide a brief overview of these exciting and potentially impactful results, along with an update on our other COVID trials. And importantly, he will cover our next steps in this program.

Well the 18 to go and we look at look forward to further acceleration as vaccine availability improves.

The enrollment progress puts us closer to our goal to be the first approved product for the treatment of warm autoimmune hemolytic anemia, and therefore, the capture of substantial share of this very significant market opportunity.

Our comprehensive COVID-19 a clinical program is advancing on multiple fronts and as we described in more detail in some detail a couple of weeks ago. We reported positive top line results from our phase II clinical trial conducted in collaboration with the NIH and the Nova.

Wolfgang will provide a brief overview of the exciting and potentially impactful results along with an update on our other other COVID-19 trials.

And importantly, he will cover our next steps in this program.

Following that Dave will highlight our view of the substantial opportunity for foster Matt in the in COVID-19 patients should appropriate regulatory approvals be obtained.

Raul R. Rodriguez: Following that, Dave will highlight our view of the substantial opportunity for foster matinib in COVID-19 patients, should appropriate regulatory approvals be obtained. And finally, we are excited to provide updates on our IRAC 1.4 program in both hemolytic and immune diseases, along with the progress of our recent RIP-1 collaboration with Lilly. Today, we'll start with Wolfgang's update on our clinical programs before we transition to Dave to discuss the commercial opportunities available to Rigel.

And finally, we are excited to provide updates on our Iraq, one for program in both Mark and immune diseases.

Along with the progress of our recent Rip one collaboration with Lilly.

So they will start with Wolfcamp update on our clinical programs before we transition to Dave to discuss the commercial opportunities available to Rigel Wolfgang.

Wolfgang Dummer: Thank you, Raul. Let me start on slide seven by reminding you why all immune hemolytic anemia is such an exciting opportunity for rights. We estimate there are about 10,000 to 13,000 candidate patients with this condition in the U.S. alone. With no FDA-approved therapies, a significant unmet medical need remains, and the opportunity is large. Forstamatinib is in the advanced stages of Phase III development and would be first to market in this indication.

Thank you Raul.

Let me start on slide seven.

By reminding you why all of the immune hemolytic anemia is such an exciting opportunity for rigel.

We estimate there are about 10 to 13000 can't do the patients with this condition in the U S alone.

With no FDA approved therapies, a significant unmet medical need remains and the opportunity is large.

For some of it is in the advanced stages of Phase III development and would be first to market in the syndication the.

Wolfgang Dummer: The product has FDA FOSTRAC as well as orphan drug designation. AIHA does have many synergies with ITP, including the customer infrastructure that's already in place because the physicians treating ITP are the same physicians who will treat AIHA.

It has FDA fast track as well as orphan drug designation.

Hey, a J does have many synergies with the ATP, including the customer infrastructure, that's already in place because of the physicians treating ATP or the same physicians, who treat the eiichi. Therefore, a lot of familiarity with the most of them up on it already exists and we'll be there right at launch.

Wolfgang Dummer: Therefore, a lot of familiarity with fostamatinib already exists and will be there right along. [inaudible] gives you a brief update on our Phase 3 study. Despite the COVID-19 pandemic still ongoing, we continued to steadily randomize patients into the trial. As Raul mentioned, as of today, we have 72 patients randomized. 46 of those patients have also reached week 24, and 100% of those have rolled over into the extension study as well. Due to the pandemic conditions, we can't accurately project when we will complete enrollment, but we remain confident that we are very well positioned to keep or even expand the lead to become the first drug approved in the syndicate. Slide 10.

Slide eight.

Gives you a brief update on our phase III study.

Despite the COVID-19 pandemic still ongoing we continue to steadily randomized patients into the trial. Its Raul mentioned as of today. We have 72 patients randomized 46 of those patients have also reached a week 24, and 100% of those have rolled over into the extension of <unk>.

<unk> as well.

Due to the pandemic conditions, we can't accurately predict when we will complete enrollment, but we remain confident that we are very well positioned to keep or even expand the leads to become the gross drug approved in the state.

The syndication.

Okay.

Slide 10.

Is the brief status update on our other programs starting with the Iraq.

Wolfgang Dummer: Here's a brief status update on our other programs, starting with IRAC. We continue to plan for clinical trials in the hemonc space, currently targeting low-risk MDS as the lead indication. We have initiated discussions with the FDA and recently submitted a pre-IND package. We've also initiated collaboration discussions with academic partners in this indication.

We continue to plan for a clinical trial in the hemo on space currently targeting low risk Mds is the lead indication.

We have initiated discussions with the FDA and recently submitted the pre IND package.

We've also initiated collaboration discussions with academic partners in this indication.

We will also evaluate and discuss ria immune diseases with the strong scientific rationale for Iraq inhibition, such as Palmoplantar pushed the losses, well hidradenitis, suppurativa and obtain FDA feedback as well.

Wolfgang Dummer: We will also evaluate and discuss rare immune diseases with a strong scientific rationale for AIRAC inhibition, such as Palmoplantar Pustulosis or Hydradenitis Superativa, and obtain FDA feedback as well. Finally, we are well into the collaboration with Lilly on our RIP inhibitor R552 and are planning to initiate a Phase II study this year. Moving to slide 12.

Finally, we are well into the collaboration with Lilly on a rip inhibitor or five five true.

On a planning to initiate a phase III study this year.

Moving to slide 12.

We've shown you a lot of preclinical experimental data in the last few earnings call, but now we are extremely excited that this has translated into very positive clinical data in extra of human patients hospitalized with COVID-19.

Wolfgang Dummer: We've shown you a lot of preclinical and experimental data in the last few earnings calls, but now we are extremely excited that this has translated into very positive clinical data in actual human patients hospitalized with COVID-19. You saw the press release informing you of the very positive outcomes from the Phase II NIH trial, and I will get to that in a bit. As you know, Fostermartinib is a commercially available product under the brand name Tavalis.

You saw the press release informing you of the very positive outcomes from the phase II NIH trial, and then we get to that in a bit.

As you know forced the math is a commercially available product under the brand named tab of lease. It has a well established safety database of approximately 4800 patients and could be rapidly repurposed as a treatment for COVID-19, after the appropriate regulatory approvals.

Wolfgang Dummer: It has a well-established safety database of approximately 4,800 patients and could be rapidly repurposed as a treatment for COVID-19 after the proper regulatory approval. Dr. Matanib is now in three clinical trials for COVID-19. We are currently enrolling our Rigel-sponsored Phase III trial with financial support from the Department of Defense. And we have two investigator trials, one of which, the NIH study, just generated terrific data. Slide 13.

Post Imatinib is now in the three clinical trials in COVID-19, we are currently enrolling our rigel sponsored phase III trial with the financial support from the Department of Defense and we have two investigator trials, one of which the NIH study just generated terrific data.

Slide 13.

Just a reminder to show you the sick inhibition with force them up and it involves multiple pathways that are relevant for COVID-19. It is not just the one cytokine inhibitor. It is quite differentiated both.

Wolfgang Dummer: Just a reminder to show you that sick inhibition with fostamatinib involves multiple pathways that are relevant for COVID-19. It is not just a single cytokine inhibitor; it is quite differentiated. Fostamatinib not only regulates several cytokines, but it can also improve excessive metosis, as well as endothelial cell activation, and thereby reduces risks of small and large blood vessel clotting. This hypercoagulability leads to multiple organ damage, kidney failure, respiratory distress syndrome, and ultimately death.

Most of them at the need nor the only regulates the real tie the kinds of it can also improve existing net proceeds as well as endothelial cell activation and thereby reduces the risks of small in the blood vessel clothing.

This hypocoagulability leads to multiple organ damage kidney failure respiratory distress syndrome, and ultimately death.

Slide 14 shows you the various patient populations covered with all the clinical program.

Wolfgang Dummer: Slide 14 shows you the various patient populations covered by our clinical program. The recent data from NIH included patients with a 5, 6, or 7 rating on the widely used 8-point ordinal scale, meaning the most severe patients. That has particular interest because these patients are presumably the hardest to treat. The Imperial College London study in our Phase 3 clinical trial will include milder patients with scores in the 3, 4, and 5 range, and we'll investigate the progression of mild patients to severe disease.

The recent data from NIH included patients with the five six or seven the reading on the widely used eight point on the scale, meaning the most severe patients.

Net debt has particular interest because these patients are presumably the hardest to treat.

The Imperial College, London studying all of Phase III clinical trial will include milder patients with scores in the three four and five range and will investigate the progression of mild patients to severe disease.

Slide 15 depicts the NIH study design approximately 30 60 patients for it to be randomized one to one to eat the post imatinib plus standard of care or placebo plus standard of care. The primary endpoint is safety as measured by the incidence of serious adverse events.

Wolfgang Dummer: Slide 15 depicts the NIH study design. Approximately 60 patients were to be randomized one-to-one to either post-traumatic plus standard of care or placebo plus standard of care. The primary endpoint is safety, as measured by the incidence of serious adverse events.

In addition, the none.

Wolfgang Dummer: In addition, a number of clinical efficacy endpoints typically included in these COVID-19 studies and generally considered meaningful were also analyzed. Moreover, NIH has incorporated very powerful translational research tools that can generate valuable mechanistic data on post-traumatic COVID-19. For example, they have included numerous cytokine analyses, C-reactive protein, and other inflammatory biomarkers, and a netosis assay. Slide 16.

Of clinical efficacy endpoints typically included in the COVID-19 studies in generally considered a meaningful well also analyzed.

Moreover, the NIH has incorporated very powerful translational research tools that can generate valuable mechanistic data on post them up and they've been the COVID-19 for.

For example, the hip included numerous cytokine analysis.

The C reactive protein and the other inflammatory biomarkers.

And on the Ptosis Etsy.

Slide 16, before I move onto the NIH study I need to tell you that I will not be providing more detailed numbers beyond what was in the recent press release and presentation as to not jeopardize in anyway publication of if the entire dataset in the best possible.

Wolfgang Dummer: Before I move on to the NIH study, I need to tell you that I will not be providing more detailed numbers beyond what was in the recent press release and presentation as to not jeopardize in any way the publication of the entire dataset in the best possible medical journal. Let me summarize for you the baseline characteristics of the trial. This is based on real data now.

Medical Journal.

Let me summarize for you the baseline characteristics from the trial. This is based on the real data on though.

The baseline characteristics of the demographics were generally very well balanced between treatment groups, which is obviously very important.

Wolfgang Dummer: The baseline characteristics and demographics were generally very well balanced between treatment groups, which is obviously very important. For example, there were similar numbers of patients in both groups with underlying conditions. There was good and balanced representation of patients with a five or six on the ordinal scale. And, importantly, there were also four patients in the trial who were on mechanical ventilation, two in the foster matinib arm and two in the standard of care arm.

Were similar numbers of patients in both groups.

The with underlying conditions.

There was good imbalanced for a presentation of patients where the five or six on the it wasn't the scale.

And then importantly, they're also for patients in the trial, who are on mechanical ventilation two in the first time of the nib arm and touring the standard of care of them. So these are the most severe patients with the score of seven.

Wolfgang Dummer: So these are the most severe patients with a score of seven. There's a very high risk of death for these patients. And also important, all patients in both groups were on standard of care remdesivir and dexamethasone at about a 40% balance between groups also received convalescent plasma in both groups. All of that means that the results should be considered credible and certainly not skewed by any baseline imbalance. Slide 17.

There's a very high risk of death for these patients.

And also important all patients in both groups were on standard of care for them disappear in <unk>.

Some of the film in about 40% balance between the groups also received convalescent plasma.

In both groups.

All of that means that the results should be considered credible and certainly not skewed by any baseline imbalance.

Slide 17.

Okay.

As I said the primary endpoint in the study is a safety.

Wolfgang Dummer: As I said, the primary endpoint in the study is safety, measured by the incidence of patients with serious adverse events in both groups. In order to fully appreciate the outcome, you need to remember that the first question in this phase 2 study in COVID-19 patients was, is it safe to add fostamatinib on top of standard of care such as dexamethasone and remdesivir? So, if the incident in both groups had come out about the same or similar, we would have already met those safety goals.

Safety measure it by the incidents of patients with serious adverse events in both groups.

In order to fully appreciate the outcome you need to remember that the first the Christian in this phase II study in COVID-19 patients was is it safe to add force them up.

On top of standard of care, such as sticks of NATO, So on interim disappear.

So if the incidents in both groups had come out about the same or similar we wouldn't have already met two of those safety goals.

Wolfgang Dummer: However, the incidence turned out to be cut in half, which is substantial. If you add to that the number of serious adverse events of hypoxemia was reduced in the post-traumatic arm, you can say that the safety outcome is also a pretty good surrogate for it. On slide 18, let's look at some efficacy outcomes that are generally included in these COVID-19 studies and considered clinically meaningful. There were three deaths in the trial. All three occurred in the standard of care alone group, but there were no deaths in the foster maternity group.

The incidents of turned out to be cut in half which is substantial.

Add to that the debt the number of serious adverse events of hypoxemia was reduced in the first time of Nip arm you can see that the safety outcome is also a pretty good surrogate for efficacy.

On slide 18.

Let's look at some efficacy outcomes that are generally generally included in this COVID-19 studies and considered clinically meaningful.

There were three deaths in the trial all three of occurred in the standard of care alone group. The ROE no deaths in the post them up in the group.

Wolfgang Dummer: It is worth noting that among the four patients that I mentioned earlier who entered the study on mechanical ventilation, the two in the placebo group both died, while the two patients on ventilation in the post-traumatic group survived. That is quite remarkable given the high likelihood of death once a patient needs to be intubated and mechanically ventilated. There were other secondary clinical endpoints in the study, and I can tell you that they are all generally consistently favor fostamatinib.

Worth, noting that among the for patients that I mentioned earlier, who entered the study on mechanical ventilation the tune of the placebo group both deceased while the two patients on ventilation in the post to them up on the group survived.

That is quite remarkable given the high likelihood of day once the patient needs to be intubated and mechanically ventilated.

The other secondary clinical endpoints in the study and I can tell you that they are all generally consistently favor for stomach.

One shown here is the ordinal scale improvement.

Wolfgang Dummer: One shown here is Ordinal Fetal Gale Improvement. During the study, there was a greater improvement in ordinal scale in the fostermatinic group versus the control group. The time to improvement on fostermatin was also quite a bit shorter than in the control group. The observed changes in ordinal scale improvement were quite large.

During the study there was a great day improvement in the wasn't the scale in the first time ethnic group versus the control group.

The time to improvement on the post Imatinib was also quite a bit shorter than in the in the control group.

The observed changes in the order of that scale.

Improvement of a quite large for example of a patient.

Wolfgang Dummer: For example, a patient who meets the criteria for a 6 on the ordinal scale needs invasive ventilation. A 3-point improvement means that that patient no longer requires intervention and is ready to go home from the hospital. That is clearly a very meaningful improvement in a relatively short time. Patients on fostamatinib also spent fewer days in the ICU compared to standard of care patients. That treatment effect is not only clinically meaningful but also very relevant from a pharmacoeconomic standpoint.

Who meet the criteria for six and it wasn't that scale needs of the invasive installation.

A three point improvement means that that patient no longer required intervention and is ready to go home from the hospital. There is clearly a very meaningful improvement in the relatively short the time.

The patients on post Imatinib spent also of less days in the ICU compared to standard of care of patients there.

The treatment effect is not the only clinically meaningful but also very relevant from a macroeconomic standpoint.

Wolfgang Dummer: And finally, the clinical findings were also consistent with improvements in inflammatory biomarkers, such as mitosis, CRP, ferritin, D-dimer, etc. We see quite beautiful and supportive improvement in those biomarkers, which are generally well accepted as playing an important role in inflammation and blood clotting in COVID-19 patients. And as I said, all of these effects are in addition to remdesivir and dexamethasone, and that is quite remarkable. Slide 19.

And finally, the clinical findings of also consistent with improvements in inflammatory biomarkers such as in the ptosis CRP Farrington D dimer et cetera, we see quite beautiful and supporting improvements in those biomarkers, which are generally well accepted is playing an important role and informed.

And plus clothing in COVID-19 patients.

And as I said all of these effects or in addition.

Two of them disappear and stick submit the film.

And and that is quite remarkable.

Yeah.

Slide 19.

So what's next.

Wolfgang Dummer: So what's next? The NIH, National Heart, Lung, and Blood Institute, will continue to follow all the patients out to day 60 and do some more biomarker work. There's also some additional subgroup analysis that can be done and could be interesting.

The NIH National Heart lung and Blood Institute will continue to follow all of the patients out to day 60, and do some more of biomarker work. There's also some additional subgroup analysis that can be done and could be interesting.

David A. Santos: Of course, the NIH is preparing a publication and will submit it to a high-ranked medical journal very soon. We at Rigel are in the process of preparing an emergency use authorization application and plan to submit that to the FDA as soon as possible, which would be the most expeditious way to provide clinical benefit to patients. My last slide, 20.

Of course, the NIH is preparing a publication and we will submit to a higher ranked medical journal the journal very soon.

We at Rigel are in the process of preparing an emergency use authorization application.

The plan to submit a debt to the FDA as soon as possible, which would be the most expeditious way to provide clinical benefit for patients.

My last slide 20.

As mentioned, we are enrolling our ratio of phase III clinical trial.

David A. Santos: As mentioned, we are enrolling our Rigel Phase 3 clinical trial. The study includes hospitalized patients with mild disease who have certain risk factors for developing more severe disease. If positive, this trial could be the basis for potential label expansion for fostamatinib to treat patients with COVID-19. So, in summary, we have a multi-pronged approach to COVID-19, and we are excited by the possibility to come up with a safe and effective treatment that is still desperately needed. With that, I'd like to turn the call over to Dave.

For the study includes hospitalized patients with mild disease, who have certain risk factors to develop more severe disease.

If the positive if this trial could be the basis for potential label expansion for most of them up make to treat patients with COVID-19.

So in summary, we have a multi pronged approach to COVID-19, and we are excited by the possibility of could come up with the safe and effective treatment that the stool desperately needed.

With that I'd like to turn the call over to Dave Dave.

Thank you Wolfgang.

David A. Santos: Thank you. We are indeed very excited about the potential of FOSDMAT to help hospitalized COVID-19 patients in the near future. I'd like to spend a few minutes talking about our research to understand the market and our current projections for COVID-19 hospitalizations, as the landscape continues to evolve. As you are aware, COVID-19 is a dynamic disease dependent on many different factors. On slide 21, you can see on the left that while there are decelerators that are very important in slowing the spread and impact of the disease, they are constantly challenged by accelerators.

We are in the very excited about the potential of fast method to help hospitalized COVID-19 patients in the near future.

I'd like to spend a few minutes talking about our research to understand the market and our current projections for COVID-19, hospitalizations as the landscape continues to evolve.

As you're aware COVID-19 is the dynamic disease dependent on many different factors.

On Slide 21, you see on the left that while there are decelerate or <unk> that are very important in slowing the spread and impact of the disease. They are constantly challenged by accelerators of the disease.

Variance can increase the number of COVID-19 cases, and even though a small percentage of those patients are hospitalized a high number of hospitalizations will persist.

David A. Santos: Variants can increase the number of COVID-19 cases and, even if a small percentage of those patients are hospitalized, a high number of hospitalizations. And with few effective treatments authorized or approved for hospitalized patients.

And with you the effective treatments authorized or approved for hospitalized patients. The situation is exacerbated with more patients ending up in the ICU for on ventilators.

David A. Santos: The situation is exacerbated with more patients ending up in the ICU or on ventilators. We completed quantitative research in Q1 that took into account hospitalizations to date and these dynamic factors to project the steady state of COVID-19 hospitalizations in the future. In 2020, out of 20 million COVID-19 cases diagnosed in the U.S., there were 1.6 million hospitalizations, or approximately 8 percent of all cases. And because the number of cases was so high in the first part of this year, we estimate there will still be 16.2 million cases of COVID in 2021, and 8% of those patients will be hospitalized, for a total of around 1.3 million hospitalized patients this year.

We completed quantitative research of Q1 that took into account hospitalizations to date and these dynamic factors to project the steady state of COVID-19, hospitalizations in the future.

In 2020 out of 20 million COVID-19 cases diagnosed in the U S. There were one 6 million hospitalizations or approximately 8% of cases.

And because of the number of cases was so high in the first part of this year. We estimate there will still be $16 2 million cases of COVID-19 and 2021 and 8% of those patients will be hospitalized for a total of around one 3 million hospitalized patients this year.

On slide 22, the left side depicts monthly hospitalizations to date.

David A. Santos: On slide 22, the left side depicts monthly hospitalizations to date tracked from two CDC data sources. The black solid line depicts the COVID tracker hospitalization, and the lower orange line depicts hospitalizations seen in the COVID-NET data. Note that actual hospitalizations have been highly volatile, particularly with the surge during the fall and the winter. To determine a steady state, we first chose a level of hospitalizations that would persist without a vaccine.

Track from two CDC data sources.

The black solid line depicts the COVID-19 tracker hospitalizations.

And the lower Orange line depicts hospitalization scene in the COVID-19 net data.

Note that actual hospitalizations have been highly volatile.

Particularly with the surge during the fall and the winter.

To determine the steady state we first chose our level of hospitalizations that would persist without a vaccine.

We then applied an aggressive vaccine range of 80 per cent that we would reach rapidly by September of this year.

David A. Santos: We then applied an aggressive vaccine rate of 80% that we would reach rapidly by September of this year. And even with these aggressive assumptions for rapid deceleration... Based on the COVID tracker data, we would still project around 165 to 370,000 hospitalizations. In the second half of this, with around 250,000 to 360,000 hospitalizations in the steady state from 2022 onwards. Moving to slide 23, to provide some context on a quarter of a million or more hospitalizations each year from COVID-19.

And even with these aggressive assumptions for rapid deceleration.

Based on the COVID-19 tracker data, we would still project around the 165 to 370000 hospitalizations in the second half of this year with around 250% of 360000 hospitalizations.

In the steady state from 2022 odd.

Moving to slide 23 to provide some context on a quarter of a million or more of hospitalizations each year from COVID-19.

David A. Santos: We wanted to provide the last decade of data on annual influenza hospitalizations as a comparator. There has been an average of 442,000 influenza hospitalizations each year over the last 10 years, and it ranges from a low of 140,000 in the 2011-12 bioflu season to 810,000 in the 2017-18 more aggressive flu season.

We wanted to provide the last decade of data on annual influence of hospitalizations as the comparator.

There has been an average of 442000 influence of hospitalizations each year over the last 10 years and it ranges from a low of 140000 in the 2011 12 by flu season. The 810000 in the 2017 18 more aggressively.

The <unk> season.

And even though COVID-19 spreads more aggressively than the flu.

David A. Santos: And even though COVID-19 spreads more aggressively than the flu, with its more effective vaccine and a higher vaccine rate than the flu, we would expect to have fewer patients hospitalized. So, based on the flu data, coupled with our quantitative market research, we feel comfortable with the $250,000 to $360,000 being a reasonable projection for annual COVID hospitalizations at this time. To summarize on slide 20, we believe that there will be a great opportunity to help COVID-19 patients in both the near and longer term.

With its more effective vaccine and a higher vaccine rate than the flu, we would expect to have fewer patients hospitalized.

So based on the influence of data coupled with our quantitative market research, we feel comfortable with the 250 to 360000 being a reasonable projection for annual COVID-19 hospitalization at this time.

To summarize on slide 24.

We believe that there will be a large opportunity to help COVID-19 patients in both the near and longer term.

David A. Santos: That's because COVID-19 cases will continue to persist even with a highly effective vaccine and the vast majority of the population vaccinated. Even conservatively estimating that five to eight percent of COVID-diagnosed patients are hospitalized in the future, there could be approximately 250,000 to 360,000 hospitalizations each year. In the near term, there are very few effective treatments for hospitalized patients.

That's because of COVID-19 cases will continue to persist even with a highly effective vaccine and the vast majority of the population back to Nate.

Even conservatively estimating the 5% to 8% of COVID-19 diagnosed patients are hospitalized in the future there could be approximately 250 to 360000 hospitalizations each year.

In the near term there are very few effective treatments for hospitalized patients. So should fast imatinib received an emergency use authorization seed there can be quick uptake with very large numbers of hospitalization.

David A. Santos: So should fostamatinib receive an emergency use authorization soon, there could be quick uptake with very large numbers of hospitalizations. And even as more treatments are authorized or approved in the future, we believe the drug treatment rate of hospitalized patients will continue to increase, which would potentially open up post-traumatic abuse in earlier patients, based on our Phase III trial at Wolfgang Reck. I would now like to move on to slide 25 and discuss our progress with Tavalisse in IT.

And even as more treatments are authorized or approved in the future. We believe the drug treatment rate of hospital of these patients will continue to increase which would potentially open up Fox the Matt the abuse in earlier patients based on our phase III trial that Wolfgang referenced.

I would now like the move on to slide 25, and discuss our progress with top of lease in T. P.

David A. Santos: Q1 was a challenging quarter, and I am proud of the way our team stepped up to the challenge and continued to grow tablis in the U.S. On slide 26, you will see our FDA-approved indication, which is for adult patients with chronic immune thrombocytopenia, or CITP, who had an insufficient response to a previous treatment. Moving to slide 27,

Q1 was a challenging quarter.

I am proud of the way our team stepped up to the challenge to continue to grow top of lease in the U S.

On Slide 26, you will see our FDA approved indication, which is for adult patients with chronic immune thrombocytopenia RCI T. P who had an insufficient response to the previous treatment.

Moving to slide 27, while Q1 was challenging our results were largely consistent with historic trends and we did see a 14% increase in demand for bottles shipped to patients of clinics.

David A. Santos: While Q1 was challenging, our results were largely consistent with historic trends, and we did see a 14% increase in demand for bottles shipped to patients in clinics. In comparison to last year, we grew bottles shipped to patients and clinics from 1,397 in Q1 of 2020 to 1,599 in Q1 of this year. This 14% increase was consistent with the performance of the IPP market.

In comparison to last year, we grew bottles shipped to patients of clinics from 1300 97 in Q1 of 2020.

1500, and 99 in Q1 of this year.

This 14% increase was consistent with the performance of the ITT market.

We saw a small year over year decline of 2% and our total bottles with 1300 93 total bottles in Q1 of 2020 versus 1300 60 for total bottles, Inc. Q1 of this year.

David A. Santos: We saw a small year-over-year decline of 2% in our total bottles, with 1,393 total bottles in Q1 of 2020 versus 1,364 total bottles in Q1 of this year. The key difference between this year and last year is the significant change in inventory, or bottles remaining in the distribution channel, which Dean will discuss shortly. So in order to continue driving Tavalli's demand growth beyond 14%, we remain focused on continuing to increase the number of prescribers by growing awareness.

The key difference between this year from last year is the significant change in inventory or bottles remaining in the distribution channel, which Steve will discuss shortly.

So in order to continue driving the top of lease demand growth beyond 14 per share.

We remain focused on continuing to increase the number of prescribers by growing awareness the number of patients by driving the starts and persistency by continuing to improve pretty sales, we saw stronger trends in March and as more of <unk> patients start therapy or switched.

David A. Santos: The number of patients by driving new starts and persistency by continuing to improve refills. We saw stronger trends in March, and as more ITP patients start new therapy or switch therapies, we believe we are poised to accelerate growth as the year continues. Finally, moving to slide 8, 28.

Therapies, we believe we are poised to accelerate growth as the year continues.

Finally, moving to slide 828.

We are constantly increasing our promotional efforts to improve both persistency and new patient starts for top of leaf.

David A. Santos: We are constantly increasing our promotional efforts to improve both persistency and new patient starts for Tavaleet, as well as awareness among our hematology oncology customers. Our three newest initiatives are shown here. First, we launched a new interactive persistency program in February called Tavalis Together. It was designed for patients who are already taking topicals and for potential new patients who are interested in starting tablets.

As well as awareness among our hematology oncology customers.

Our three newest initiatives are shown here.

First we launched the new interactive Persistency program in February call on top of leased together.

It was designed for patients who are already taking copies and for potential new patients who are interested in starting probably.

It partners with patients throughout their treatment journey, helping them to become successful with the ITT treatment and achieve their goals.

David A. Santos: It partners with patients throughout their treatment journey, helping them to become successful with their ITP treatment and achieve their goal. Second, because our sales force is critically important in increasing Tavalese awareness among prescribers, in late March, we launched a new rep-generated email platform that allows our team to send product-rich, personalized messages directly to their customers. And third, because we continue to face challenges in interacting live with customers during the pandemic, we also launched another new media program to provide online education for clinicians. This media is accessible on demand to physicians on Keysight's Davis platform and contributes to our Surrounds app to raise Poviliz awareness among prescribers.

Second because our sales force is critically important in increasing top of lease awareness among prescribers in late March we launched the new Rep generated email platform that allows our team the send product rich personalized messages directly to their customers.

And third because we continue to face challenges in interacting live with customers. During the pandemic. We also launched another new media program to provide online education for clinicians. This media is accessible on demand to positions on key sites day visit and.

Contributes to our surround sound to raise <unk> awareness among prescribers.

I am confident that new promotional effort such as these combined with our growing number of sales calls and speaker programs as things continue to open up will enable us to continue to grow demand through improvements in awareness, new patients and persistency as the year progresses.

David A. Santos: I am confident that new promotional efforts such as these, combined with our growing number of sales calls and speaker programs as things continue to open up, will enable us to continue to grow demand through improvements in awareness, new patients, and persistency as the year progresses. Thanks for your attention, and then I will now turn the call over to D. D.

Thanks for your attention and I will now turn the call over to D D.

Thank you Dave.

Dean L. Schorno: I'm on slide number 30. In the first quarter of 2021, we shipped 1,364 bottles to our specialty distributors, resulting in $16.1 million in gross product sales. 1,599 of those bottles were shipped to patients and clinics, while 749 bottles remained in our distribution channels at the end of the quarter. We reported net product sales from Tavalease of $12.4 million, a 2% decrease compared to the first quarter of 2020. Our net product sales and tabloids were recorded net of estimated discounts, chargebacks, rebates, returns, co-pay assistance, and other allowances of $3.7 million. Our gross-to-net adjustment was approximately 23% of gross product sales.

On slide number 30 for the first quarter of 2021, we shipped 1360 for bottles to our specialty distributors, resulting in $16 $1 million of gross product sales 1599 of those bottles were shipped to patients of clinics for 749 bought.

<unk> remained in our distribution channels at the end of the quarter.

We reported net product sales from top of lease of $12 $4 million of 2% decrease compared to the first quarter of 2020 of.

Our net product sales from top of Louise were recorded net of estimated of discounts charge backs rebates returns co pay assistance and other of allowances of $3 $7 million of gross to net adjustment was approximately 23% gross product sales.

Before we move on from net product sales, let me review of our expectations for the second quarter of 2021.

Dean L. Schorno: Before we move on from Net Product Sales, let me review our expectations for the second quarter of 2021. While we are seeing great progress in vaccinations against COVID-19, we continue to see that physician and patient access, along with their desire to initiate new ITP treatment options, remains constrained. In the second quarter, and as we saw last year, we expect to see growth in both bottle shipment to patients and clinics, as well as increases in the levels of bottles remaining in our distribution channels.

We're seeing great progress from vaccinations against COVID-19, we continue to see the physician and patient access along with their desire to initiate new I'd keep the treatment options remains constrained in the second quarter and as we saw last year, we expect to see growth in both bottle shifts of patients and clinics.

As well as increases in the levels of bottles for many in our distribution channels coming.

Dean L. Schorno: Coming off our first quarter results, we expect these increases to result in significant quarterly sequential growth of our net product sales in the second quarter. In the back half of the year, we expect to see stronger growth in both new patient starts and overall demand as the significant constraints caused by the COVID-19 pandemic lessen. Incrementally, we currently expect our gross net adjustment to be approximately 24 or 25% in the second quarter of 2021.

Coming off of our first quarter results. We expect these increases to result in significant quarterly sequential growth of our net product sales in the second quarter and.

In the back half of the year, we expect to see stronger growth in both new patient starts and overall demand as the significant constraints caused by the COVID-19 pandemic worsen.

Incrementally we currently expect our gross to net adjustment to be approximately 24 or 25 per cent in the second quarter of 2021.

On slide 31, before I move onto a review of our financials for the quarter I wanted to provide a brief review of the dynamics of the sequential decrease in net product sales that we saw during the quarter.

Dean L. Schorno: On slide 31, before I move on to a review of our financials for the quarter, I wanted to provide a brief review of the dynamics of the sequential decrease in net product sales that we saw during the quarter. Starting with the orange bars, in the fourth quarter of 2019, we saw 1,725 bottles shipped to patients and clinics. This is our key demand metric. Incrementally, we saw an increase in bottles remaining in the distribution channel of 174 bottles, by far the largest increase we have seen. This resulted in total bottles for the fourth quarter of 2020 of 1,899 bottles, which generated $17.8 million in net product sales. Now, to review the green bars.

Starting with the Orange bars in the fourth quarter of 2020, we saw 1725 bottles shipped to patients of clinics. This is our key demand metrics.

Incrementally we saw an increase of bottles remained in the distribution channel of 170 for bottles by far the largest increase the we've seen this resulted in total bottles for the fourth quarter of 2020 of 1899 bottles, which generated $17 million of that.

Product sales.

Now to review of the Green bars in the first quarter of 2021, we saw 1599 bottles shipped to patients of clinics, the 7% drop in demand was largely expected as we experienced the typical first quarter industry challenges associated with the resetting of co pays and.

Dean L. Schorno: In the first quarter of 2021, we shipped 1,599 bottles to patients and clinics. The 7% drop in demand was largely expected as we experienced the typical first quarter industry challenges associated with the resetting of co-pays and the Medicare donut hole, delaying both new prescriptions and refills. This year we also had a full quarter of the effects of the COVID-19 pandemic. You'll note in the thin red bar that this sequential 7% reduction in demand volume resulted in a sequential reduction in net product sales of $1.3 million.

The Medicare Donut hole, the way in both new prescriptions and refills.

This year, we also had a full quarter of the effects of the COVID-19 pandemic.

You'll note in the big Red bar the fish.

Sequential 7% reduction in demand volume resulted in a sequential reduction of net product sales of $1.3 million.

Dean L. Schorno: The bigger impact in this sequential reduction in net product sales came from the reduction of inventory levels at our distributors. The reduction from 984 bottles of inventory at our distributors in Q4 of 2020 down to 749 bottles at the end of Q1 of 2021 contributed to a sequential decline in our net product sales of $4.1 million. The thick red bar in this graph.

The bigger impact on the sequential reduction of net product sales came from the reduction of inventory levels at our distributors. The reduction from 980 for bottles of inventory at our distributors in Q4 of 2020 down to 749 bottles at the end of Q1 of 2021.

<unk> for a sequential decline in our net product sales of $4 $1 million pick red bar on the scrap there.

Dean L. Schorno: Inventory levels at our distributors are variable, and we do expect them to generally increase over time as our business grows. Moving on to the next slide, in addition to net product sales, Rigel's contract revenues from collaborations were $65.6 million for the three months ended March 31st, 2021, which consisted of $60.6 million from Lilly relating to our collaboration agreement. $4 million for the grant of a non-exclusive license and $1 million for the delivery of the drug supply pursuant to our collaboration with Griffin.

Inventory levels at our distributors of variable and we do expect them to generally increase over time as our business growth.

Moving onto the next slide.

In addition to the net product sales <unk> contract revenues from collaborations were $65 $6 million for the three months ended March 31, 2021, which consisted of $66 million from Lilly relating to our collaboration agreement for millions of dollars for the grant of the non exclusive license.

And $1 million the delivery of drug supply pursuant to our collaboration with peripherals.

Dean L. Schorno: Government contract revenues of $3 million were related to income we recognize pursuant to our agreement with the U.S. Department of Defense for our ongoing phase three clinical trial of fostamatinib in COVID-19. Moving on to cost and expenses, our cost of product sales was approximately $316,000 for the first quarter of 2021.

The government contract revenues of $3 million was related to income we recognize pursuant to our agreement with the U S Department of defense for our ongoing phase III clinical trial of Foster Mountain Dew and COVID-19.

Moving on to cost and expenses our cost of product sales was approximately $316000 for the first quarter of 2021.

Dean L. Schorno: Total cost and expenses were $39.3 million for the first quarter of 2021 versus $34.7 million in the first quarter of 2020. The net increase in costs was primarily due to increases in personnel-related costs, stock-based compensation expense, and research and development costs related to our various ongoing clinical studies. During the quarter, we recorded a provision for income taxes of $1.8 million.

Total costs and expenses were $39 $3 million for the first quarter of 2021 versus $34 $7 million in the first quarter of 2000 Twenty's.

The net increase in cost was primarily due to increases in personnel related costs stock based compensation expense and research and development costs related to our various ongoing clinical studies during.

During the quarter, we recorded a provision for income taxes of $1.8 million relating to estimated state income taxes.

Dean L. Schorno: Relating to Estimated State Income Tax, Finally, we ended the quarter with cash, cash equivalents, and short-term investments of $39.3 million. In April, we then incrementally received a $125 million upfront cash payment from Lilly for the exclusive license agreement for our RIP-1 inhibitor program. Moving on to slide 33, let me take a minute to remind you of a few key aspects of our first quarter collaboration with Lilly. Lilly Rigel will develop and commercialize Rigel RIP-1 inhibitor R552 for all indications, including autoimmune and inflammatory disease. Lily will lead the clinical development of central nervous system-penetrated RIP-1 inhibitors.

Finally, we ended the quarter with cash cash equivalents and short term investments of $39 $3 million.

April we then incrementally received of $125 million upfront cash payment from Lilly for the exclusive license agreement for a reported inhibitor program.

Moving on to Slide 33, let me take a minute to remind you of a few key aspects of our first quarter collaboration with Lilly.

Moving and Roger will develop and commercialize Roger of reported inhibitor are 552 for all indications, including the autoimmune and inflammatory diseases moving will lead the clinical development of central nervous system penetrated reported inhibitors.

Dean L. Schorno: In April, we received a $125 million upfront payment from Lilly and are eligible to receive up to an additional $835 million in potential future milestone payments, as well as tiered royalties on net sales. Development costs for R552 will be shared between our companies, subject to certain knockout provisions for rideshare. Most importantly, this partnership has the potential to bring forward a new class of compounds in both immune and CMS indications, which could address very large and important medical needs. With that, I'd like to turn the call back over to Raul. Thank you, Dean.

In April in April we received the $125 million upfront payment from Lilly and are eligible to receive up to an additional $835 million in potential future milestone payments as well as tiered royalties on net sales.

<unk> costs for our 552 will be shared between our companies subject to certain opt out provisions for rigel.

Most importantly, this partnership has the potential to bring for the new class of compounds and both the immune and CNS indications, which could address the very large and important medical needs without I'd like to turn the call back over to Ralph.

Thank you Dean.

Given the progress and the opportunities that the team has described on this call. Let me highlight some of the key milestones for the business, we anticipate for the remainder of the year.

Raul R. Rodriguez: Given the progress and the opportunities that the team has described on this call, let me highlight some of the key milestones for the business that we anticipate for the remainder of the year. In ITP, we expect to look forward to the lessening of significant access restrictions to physicians and patients caused by the COVID pandemic, allowing for increased interactions and an acceleration of new patients benefiting from Tavalis. In AIHA, we expect to complete enrollment in our Phase 3 clinical trial and continue our preparations to meet the unmet medical needs of patients with warm autoimmune hemolytic anemia and capture a significant portion of this very large market opportunity. With the significant opportunity for MATNIP to foster in COVID-19, we will file an EUA based on phase two data from our trial conducted by the NIH and Inova and do so as soon as possible.

In <unk>, we expect the look forward to the lessening of significant access restrictions to physicians and patients caused by the COVID-19 pandemic, allowing for increased interactions and an acceleration of new patients benefiting from the lease.

In the area, we expect to complete enrollment of our phase III clinical trial.

And continue our preparations to meet the unmet medical needs of patients with warm autoimmune hemolytic anemia and capture a significant portion of this very large market opportunity.

With the significant opportunity for foster Matt the COVID-19, we will file the EUA based on phase II data from our trial conducted by the NIH and the Novo and do so as soon as possible.

We will continue and complete enrollment of our own phase III trial later this year.

Raul R. Rodriguez: We will continue and complete enrollment in our own Phase 3 trial later this year. We will also advance this tremendous opportunity to benefit patients suffering from COVID-19. With our RIP-1 collaboration with Lilly, we look forward to initiating a Phase 2 trial in a large immunity. And we will make progress with our IRAC 1.4 program in both hemlock and immunity. That's quite a lot of milestones coming later this year.

We will also advance this tremendous opportunity to benefit patients suffering from COVID-19.

With a rip one collaboration with Lilly, we look forward to initiating a phase II trials in the large immune indications.

And we will make progress with our IraQ1 for program in both came on and immune indications.

That's quite a bit of milestones coming later this year.

Operator: So with that, let me open the call up to you. At this time, we will 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 zone 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.

So with that let me open the call up for your questions.

At this time, we will be conducting a question and answer session. If you would like to ask the question. Please press star one on your telephone keypad of confirmation so indicators of line isn't the question queue you.

You May press Star two of you would like to remove your question from the queue.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, as we poll for questions. Our first question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question. Hi, Raul and team.

For participants using speaker equipment, it may be necessary to pick of per handset before a person of the sarkies. One moment. Please as we pull for questions.

Our first question comes from the line of Eagle Natural mothers with Citigroup. Please proceed with your question.

Hi, Raul and team thanks for taking the questions on I T. P. Can you comment a little bit more on the recent market dynamics from the second quarter and specifically would you mind elaborating on the comment you made regarding continued ICP market constraints in the second quarter of this year given the pandemic I guess I would've thought that with the increase the availability of vaccinations and start to.

Yigal Dov Nochomovitz: Thanks for taking the questions. On ITP, can you comment a little bit more on the recent market dynamics in the second quarter? And specifically, would you mind elaborating on the comment you made regarding continued ITP market constraints in the second quarter of this year, given the pandemic? I guess I would have thought that with the increased availability of vaccinations, you would start to see positions at offices returning to pre-COVID levels in April and going forward in this quarter.

The physician's office since returning to pre COVID-19 levels in April and going forward in this quarter. So any further comments there would be super helpful. Thanks.

Yigal Dov Nochomovitz: So any further comments there would be super helpful. Sure, Yigal. Thank you for the question. I'll also ask Dave to comment on that, on those constraints. Dave, why don't you comment first, and I'll add my comment afterward.

Sure you got a nice thank you for the question I'll also ask Dave to comment on that on those constraints. Okay. What did you comment the personnel of all although at common after that.

Raul R. Rodriguez: Sure, Raul. A great question, Yigal. I want to say, first of all, that in the first quarter, what we saw were much stronger trends as we moved into March. So, clearly, we believe that this was due to those delays that Dean spoke about in the first quarter. And so, we saw those stronger trends in demand as we moved into March, and I think I'll just say that April looks a lot more like March than it did in January and February.

Sure Raul.

Great question.

One of say first of all of that are in the first quarter. What we saw was.

Much stronger trends as we moved into March so clearly we believe.

This was due.

Two of those delays of Dean spoke about in the first quarter and so we saw those are the stronger trends in demand as we moved into March and.

I think I'll, just say that April looks a lot more like March than it did.

January and February and too as we've moved into April, though we have seen more things open up but it's relative right I mean as people have gotten more vaccines. You are correct. Some offices are opening up our reps are getting out and as matter of fact, I just got an update this morning.

David A. Santos: And so, as we've moved into April, though, we have seen more things open up, but it's relative, right? I mean, as people have gotten more vaccines, you are correct. Some offices are opening up.

David A. Santos: Our reps are getting out. And as a matter of fact, I just got an update this morning. Out of our sales force, approximately more than 80% of them are able to get out for some live interactions. The trick of that is that some of our territories who are able to do that might have one office they can go to or one speaker program.

Out of our sales force approximately more than 80% of them are able to get out on some live interactions. The trick of that is is it some of our territories, who are able to do that might have one office, they can get to or one speaker program and others, although they might have more.

David A. Santos: And others, although they might have more, it's not at all like things have opened up completely in their territories. And so, that's why we're saying that as we move into the back half of this year, as things return more to normal, we feel like things will be more loosened up, and we will be able to see our customers on a more frequent basis than we are now. So, it's all relative. Certainly, compared to late last year and early this year, we're seeing more people live. And I think our speaker programs and our sales calls are showing that. But it's nothing like everybody's out in the field for a full day seeing customers each day.

It's not at all like things have opened up completely in their territories and so that's why we're saying that as we move into the back half of this year as things return more to normal.

We feel like things will be more leasing debt and we will be able to see our customers on a more frequent basis that we are now so it's all relative certainly compared to.

Too late last year early this year, we're seeing more people lives and I think our speaker programs and our sales calls are showing that but.

But Tim.

It's nothing like everybody is out on the field for a full day seeing customers each day that debt.

David A. Santos: We're not close to that yet, so I just wanted to make that clear. I hope that makes sense... Yes, thanks. I did have one other question, totally unrelated to IRAC4, related to IRAC4, Raul, I'd just be curious, you mentioned that you're going to start a study in MDS, could you just comment briefly on what the evidence is supporting the role of IRAC4 inhibition in MDS, as well as the evidence for IRAC4 in palmoplanter, pustulosis, and hydrotensin. Supertiva.

Close to that yet so I just wanted to make that clear I hope that makes sense Hugo.

Yes. Thank you.

And then the.

One other question totally unrelated related to Iraq for or will just be curious you mentioned the internet.

Let's start the study in Mds could.

Could you just comment briefly on what what the evidence supporting the role of Iraq for inhibition and an M D S as well as the evidence.

The evidence for Iraq for and the Palmoplantar cluster of other CIS and headroom to dentists.

So for Teva.

Sure absolutely so and as you know Iraq for is useful.

Raul R. Rodriguez: Sure, absolutely. So, as you know, IRAC4 is useful in any indication where its IL-1 or IL-2-like receptor inhibition is useful. And, as you may know, a low-risk MDS effectively is inflammation of the bone marrow. And that's one of the areas where there might be some interest in using a molecule like this. In PPP and HS, also similarly, and there's animal data that we posted on last year in terms of some of those models in, say, psoriasis, that might be useful. And I'll ask Wolfgang to comment as well, if it helps. Yeah, Raul, you took most of it away.

Any indications, where it's IL, one or all of our.

Toll like receptor inhibition is a useful.

As you May know low risk Mds effectively is inflammation of the bone marrow and that's one of the areas of where there might be of interest in using the molecule like this in the PPP and the Hs also similarly on theirs.

Our animal data that we posted on the.

The last year.

In terms of some of the models and say psoriasis are that might be useful in the Alaska wolfcamp, the competence coming as well.

Helpful.

Yeah.

Yes for all of you took care of most of it the way just to reiterate yet.

Wolfgang Dummer: Just to reiterate, yes, in low-risk MDS, it is believed that the inflammatory compound is very strong, and that leads to the cytopenic stage. So with low blood counts of various cell types, and that could be positively impacted by IRAC inhibition. So that's the scientific rationale, and as Raul mentioned, we have some preclinical data to support that. For PPP and hydradenitis superativa, you know, for hydradenitis superativa, there's already preliminary proof-of-concept data out there from another company.

Low risk Mds.

It is believed that there is the inflammatory of compounds.

To be very strong in the it leads to the sites of Pinnacle's stage.

So with low blood counts of various cell types.

And that could be.

The positively impacted by Iraq inhibition. So that's the scientific rationale and as Raul mentioned, we have some preclinical data to support that.

For the P. P P and hidradenitis Suppurativa had revenue of 90 Super cheap. It is already preliminary proof of concept data out there from from a from another company and we have very good so on scientific rationale for the from a plant the push of the losses. These are also indications of multiple large.

Wolfgang Dummer: And we have a very good scientific rationale for hemoplanta prustellosis. These are also indications that are not so large. So there are smaller indications, and we feel in a position that we could develop all the way through approval at Rigel alone if we choose to do that without a partner. Got it. Thank you very much. Our next question comes from Unai Eun Yang with Jefferson. Please proceed with your question.

So there.

The smaller indications and we feel in a position that we could develop those all the way through approval at the rights of the alone if we choose to do that with all the parts now.

Got it thank you very much.

Our next question comes from Michael Yang with Jefferies. Please proceed with your question.

Thank you for top of list in COVID-19.

Eun Kyung Yang: Thank you. For tablets and COVID-19, can you comment on your phase 3 trial which began earlier this year? Can you talk about the enrollment rate as well as when we might expect data?

Can you.

Comment on your pages.

The city trial all of it to pick on how would you begin already on this here can you talk of that enrollment rate is one of us when we might expect the data. Thank you.

Raul R. Rodriguez: Thank you, Eun. I'll ask Wolfgang to also... Yeah, sure.

Thank you your Alaska Wolfgang to also take some of them.

Yeah sure Yeah, we are in the in the process of activating all of the sites, we or you have regulatory approval to the several countries the United States, Brazil, Argentina, and we on the process of getting all the sites on board, we have installed at our enrolment and it's <unk>.

Wolfgang Dummer: Yeah, we are in the process of activating all the sites. We have regulatory approvals in several countries, the United States, Brazil, Argentina, and we're in the process of getting all sites on board. We have started enrollment, and it's picking up quite well. We have just passed an initial DMC review of the first number of patients to establish that everything is safe, and everything is safe. So we have reopened enrollment, and we are getting up to 40 sites across five countries on board. We do feel comfortable that we will have the data before the end of the year.

<unk> up quite well are we have just passed the initial the DMC review of the the first number of patients to establish that everything is safe and everything is safe. So we have reopened the enrollment and we you know getting getting up to 40 sites.

Across five countries on board, we do feel comfortable debt, we will have the data before the end of the year.

Okay, and then warm hemolytic anemia so.

Eun Kyung Yang: Okay, and then warm hemolytic anemia. You mentioned that given the pandemic, it's hard to predict when the enrollment would be completed, but compared to your last update, it looks like you added about six patients every two months, so you know, by the end of the third quarter or beginning of the fourth quarter, is that the kind of time that you think is reasonable to expect enrollment completion? Thank you.

I mean, you mentioned debt given the pandemic and its a hard to predict when the enrollment.

But the compare to your last update and look for like are you the added about six of patients.

Have any two months of so.

The high end of the third quarter or beginning of the fourth corner of is that the kind of of time debt.

Time debt do.

Do you think of reasonable to expect for your home on competition. Thank you.

Wolfgang Dummer: Yeah, the short answer to that is, yes, that's what I expect. But we've seen ups and downs, you know; suddenly you have an outbreak somewhere else and normalization somewhere else. That's why we are a little bit cautious to name a quick date, a firm date.

Yeah. The short answer to that is yes, that's one of the that's what I expect but we've seen ups and downs.

Suddenly you have in the outbreak somewhere else and normalization of someone else. That's why we are that's where the a little bit.

The cautious two main of Creek date from data, but as you as you're saying if you take care of hand calculator in full of our enrollment yes, you could.

Raul R. Rodriguez: But as you say, if you take your hand calculator and follow our enrollment, yes, indeed, that would sort of put you in the third quarter. Thank you. Add to that, we have quite a number of sites open, as you may know, 80 to 90 sites across the world. And their goal is to get those remaining 18 patients. So when you look at 80, 90 sites open and 18 patients to go, I think we're comfortable we could do that this year and, hopefully, by Q3. And our next question comes from Doe Kim with BMO Capital Markets. Please, begin with your question. Hi, good afternoon.

So the put you on the third quarter.

Thank you.

You're not on how to add to that we have quite a number of sites open as you may know 80 to 90 sites across the world.

And their goal is to get those remaining 18 patients. So when you look at 890 sites open.

And 18 patients to go I think I think for comfortable we could do that this year and hopefully by Q3.

Our next question comes from the line of do Kim with BMO capital markets. Please share with your question.

Hi, good afternoon. Thanks for taking my questions. So first on tab of lease.

Doe Kim: Thanks for taking my questions. So first, on Tavalese, understanding that the inventory channels can be volatile. Was there any particular reason that you could identify why the drawdown was so big this quarter? Is it a COVID impact?

Understanding of that the inventory channels can be volatile.

Was there any particular reason that you could identify why the draw down was so big this quarter is that of is it. The COVID-19 impact did you have challenges in the supply chain of distribution.

Raul R. Rodriguez: Did you have challenges in the supply chain or distribution? I'll ask, I'll take a stab at that and ask Dave to also comment. The answer to the latter question: no, we did not have any issues with supply on our side. So we have ample supply on hand for ITP and COVID and other indications. So that certainly wasn't the problem.

Yes.

Oh, I I'll ask I'll take the separate that net debt to also come in the answer to the latter question no. We did not have any issues with supply on.

Our own are on our side. So we have ample supply on hand for for RTP on COVID-19 and the other indications. So that certainly wasn't the problem may be Dave you may want to comment on any other insight in terms of what happened.

David A. Santos: Maybe, Dave, you might want to comment on any other insights in terms of what happened. Sure, the only thing I would just add to your comments, Raul, is that, you know, inventory can be variable. And, you know, distributors try to keep a level on hand consistent with the current demand, and that's oftentimes a bit of a challenge to do.

Sure. The only thing I would just add to your comment of travel.

The inventory.

Tori can be variable and the.

On the distributor is try to keep a level of on hand, consistent with the current demand.

And that is sometimes a bit of a challenge to do and as I said.

David A. Santos: And as I said, we ended the year, as you know, very strong. But then, in the first and second month of this year, you know, we experienced some delays. And so that affects your demand. And obviously, inventory levels can go down. But that certainly, I don't think explains all of it.

We ended the year as you know very strong, but then first and second months of this year.

We experienced some delays into that affects your demand and obviously inventory levels can go down but that certainly I don't think explains all of it.

Doe Kim: The demand-driven part of the inventory, I think it's just an issue of timing, lots of different things, and just the variability in the distribution channel. Okay, got it. Just to remind you, last year we had about a hundred bottles increase in inventory per quarter. So, obviously, December was high, 174, and then negative 235 in Q1, very significantly different from that. Yeah, I see.

On the demand driven part of the inventory I think it's just an issue of timing lots of different things.

Just the variability in the distribution channel.

Okay. So just to remind you.

Last year, we had about almost of 100 bottles increasing inventory per quarter.

So obviously December was high at 174, and then negative $2 35 billion.

In Q1 very significantly different from that.

Yep I see.

And a question on.

The COVID-19.

Doe Kim: And a question on the COVID EUA that you're planning to apply for. Is that decision somewhat driven by your ongoing discussions with regulatory agencies? Do you comment on the quality of feedback from the FDA? Sure, I'll ask Wolfgang to comment on that.

U a E. The way that you're planning to apply for them.

Is that decision.

The somewhat driven by your ongoing discussions with regulatory agencies.

Could you comment on just the quality of feedback from from the F. D. A.

Sure I'll, let Scott Wolfgang to comment on that.

Wolfgang Dummer: Yeah, the answer to that is yes. We have been in what's called pre-EUA discussions with the FDA for a while. They basically tell you the format and the form by which you would have to submit the data.

Ah yes, the answer to that is yes, we we have been for a while in what's called the pre EUA discussions with the U F. D. A day basically tell you the format and the for them. That's in spite of which you would have to submit the data and then when the NIH day there.

Wolfgang Dummer: And then when the NIH data came out and we issued the press release, we discussed their press release with the agency, and the agency said they would be happy to review an EUA application. And therefore, we are in the process of transferring all the data from NIH in the right format, writing up the data story for regulatory purposes, and submitting it, as we said, as soon as possible. Great, that's fantastic; congratulations on the progress. Thanks, Joe. Our next question comes on the line from Chris Raymond with Piper Sandler. Please proceed with your question. Hey, thanks. Just a couple questions.

Came out and we issued the press release we.

Discuss the press release with the agency and the agency said they would be happy to review E application in the in.

And therefore, we are in the process of transferring all the data.

For me NIH in day rates for me, it's writing up the the theater story of.

For regulatory purposes, and submit the as we say the as soon as possible.

Great that's fantastic congrats on the progress.

Thanks, Joe.

Our next question comes from the line of Chris Raymond with Piper Sandler. Please proceed with your question.

Hey, Thanks, just a couple of questions I think so first I just wanted to maybe probe a bit on your answer to a previous question on the warm hemolytic anemia program. So just going back for the last few quarters. It. It doesn't look like the the pace has slowed if I just do the math from Q3 of 'twenty when you re <unk>.

Raymond J. Furey: I think, so first, I just wanted to maybe probe a bit on your answer to a previous question on the warm hemolytic anemia program. So just going back to the last few quarters, it does look like the pace has slowed, if I just do the math from Q3 of 20 when you reinitiated enrollment. And I think I heard you guys say that you think you can finish enrollment, get those last 18 patients, and hopefully in the third quarter. That presupposes, I guess, a pretty sizable uptick from the trend. Is that not correct?

The enrollment I think I heard you guys say that you think he can finish enrollment we get the last 18 patients and hopefully in the third quarter.

That presupposes I guess, a pretty sizable uptick from from the trend is that not correct is that something that you are.

Raymond J. Furey: Is there something that you're.. you know, that you're seeing that would give you that confidence? Can you maybe give a little more color on that, please? Sure, I'll take a stab. But then Wolfgang, also, after.

You know that youre seeing that debt that would give you that confidence can you maybe give a little more color on the on the on that please.

Sure I'll take a stab at the Wolfcamp also after.

Raul R. Rodriguez: You know, what we were doing very well, the pandemic hit; we were like eight or nine before the pandemic hit; the pandemic hit, driven that down substantially for most of last year, but things improved between the first and second wave. I think we had about five or so patients, maybe six in October of last year, for example. And then the second wave hit, driving that down substantially at the end of last year and early part of this year.

You know, what we were doing very well the pandemic kit for like eight or nine before pandemic the pandemic hit.

Driven debt down substantially for most of last year things improved there between the first and second wave, but I think we had about five or so patients make the six in on.

<unk> of last year for example, and then the second wave hit driving that down substantially at the end of last year and early part of this year and then.

Raul R. Rodriguez: And then now more in the last couple months, we've seen an increase now in enrollment, maybe about six in two months, three a month, at most recently, which is very encouraging given that. We should also see upticks in screening as well. So, as Wolfgang said, we're not clear what the number is when the month later this year we'll be fully enrolled. We need 18 more patients. We've enrolled six in the last two months.

Now more in the last couple of months, we've seen an increase now in the enrollment maybe about 62 months three a month.

Most recently, which is very encouraging given that well also see upticks in screening as well.

So as Wolfgang said, we're not clear what the what the number is the.

Later this year will be fully enrolled we need 18 more patients we have enrolled six in the last two months. So just by simple math in six months, we should get those patients six months from now May June July August September October ish, maybe we think there'll be some acceleration of enrollment because people.

Raul R. Rodriguez: So just by simple math, in six months, we should get those patients. Six months from now, May, June, July, August, September, October-ish, maybe, we think there'll be some acceleration of enrollment because people are getting more vaccinated.

Aren't getting more vaccinated, we are seeing more activity as Dave and the others mentioned on the call. So we do think that the we're optimistic we can do a little better than the three a month and if we get to for months.

Raymond J. Furey: We are seeing more activity, as Dave and others mentioned on the call. So we do think that we can do a little better than three a month. And if we get to four a month, you know, for a month or two, we'll be in Q3. Okay, thank you.

For a month or two will be will be in Q3.

Okay. Thank you and then.

Raymond J. Furey: And then, not to belabor the inventory point, but just so I'm clear, and by the way, Dean, thanks for all the detail. I know you actually, last quarter, called out these 174 bottles and sort of did warn that revenue would be sequentially down this quarter. But I just want to make sure I understand that I'm just kind of speculating that maybe that 235 bottle drop you saw might have been more than you guys thought.

Not to belabor, the inventory point, but just I want to clarify.

And by the way from Dean Thanks for all of the detail I know you actually last quarter, you called out the 170 for models and sort of did warn that that revenue would be sequentially down this quarter, but I just wanted to make sure I understand that the.

I'm just kind of speculate maybe the 235 bottle of drop you saw it might have even been more than you guys thought.

Raymond J. Furey: I'm just wondering, can you be descriptive of whatever inventory agreements you have in place? Um, you know, sometimes people will have these to, um..., you know, ensure that this sort of phenomenon is smoothed out. And, you know, as we all know, we sometimes see this kind of stuff in front of an anticipated price increase, for example. Can you just walk us through what parameters you have in place to sort of keep things steady? Maybe I could ask Dave and then Dean also to comment on that. The answer is that it was a very unusual and large increase at 174.

I'm just wondering do you guys can you be descriptive of whatever inventory agreements you have in place.

You know sometimes people will have these to.

Sure the debt.

The sort of phenomenon and smoothed out and you know as we all know we sometimes you see this kind of stuff in front of of unanticipated price increase for example can you just walk us through what what parameters you have in place to sort of keep things.

The state.

Maybe I could ask Dave and Dean also to comment on that the the answer.

It's a it was a very.

Unusual and large increase of 170 for them as you said, we pointed that out and this was an unusual and a large decrease in the other way it's hard for us to project or control that frankly in terms of any kind of useful way in the short term obviously in the long term, we expect and have been seeing the steady increase.

Raul R. Rodriguez: And as you said, we pointed that out. And this was an unusual and large decrease in the other way. It's hard for us to project or control that, frankly, in terms of any useful way in the short term. Obviously, in the long term, we expect and have been seeing a steady increase. Maybe Dave or Dean, would you like to comment on that?

Maybe Dave or Dan do you want to comment on that.

David A. Santos: I would just say that, again, when you work with the distributors, they're going on their most recent demand and trying to maintain a certain level of inventory. And that's not a perfect science. And so, what happened, as Raul said, is, again, you're a little high or high as we've been as we move to the end of the year, and then, frankly, one of the lowest that we've been in a long time.

I would just say that again.

When you work with the distributors you know theyre going on.

Their most recent demand and trying to maintain a certain level of inventory and that's not a perfect science and so what happened is as Raul said is again, you know youre, a little high or high the highest we've been as we move to the end of the year and then frankly, one of the lowest that we've been in the.

A long time, and so I think.

David A. Santos: And so I think, you know, we saw that variability kind of affect us. But it, it's, I think the important thing to get across is the underlying business. And that's why we focus on total bottle shipment to patients and clinics, which is our demand. That's what we focus on. And every day when I talk with my team, that's what we focus on. We don't focus so much on the bottles that we're shipping to our distributors; we focus much more on the bottles that we ship to patients and clinics.

We saw that variability kind of affect us, but it's I think the important thing to get of crosses the underlying business and that's why we focus on total bottles shipped to patients and clinics, which is our demand. That's what we focus on an every day when I talk with my team that's what we focus.

We don't focus so much on the the bottles that.

We're shipping to our distributors, we focus much more on the bottles shipped to patients of clinic. So I'll turn it over to Dean if he has anything else that.

David A. Santos: So I'll turn it over to Dean if he has anything else to add. There is nothing really incremental to add other than, you know, there are factors, you know, what day of the week the quarter ends, and there's just a variety of factors that also come into play just from the administrative mechanics of the ordering patterns.

Yeah.

Net nothing really incremental to add other than you know there are there are factors what day.

Of the week the quarter ends and there's just a variety of factors.

It also come into play just from an administrative mechanics of the of the ordering patterns.

Dean L. Schorno: Great. Thank you. Our next question comes from Joe Pantginis with HC Wainwright.

Yes.

Great. Thank you.

Our next question. Thanks, a lot of drill thank goodness with H C. Wainwright. Please proceed with your question.

Joseph Pantginis: Please proceed with your question. Hey everyone, good afternoon, thanks for taking the time. A couple.

Hey, everyone. Good afternoon. Thanks for taking the question a couple of first maybe for Dean I was just curious with regard to how we can view the G&A line going forward, specifically with the sales force.

Joseph Pantginis: First, maybe for Dean, I was just curious with regard to how we can view the GNA line going forward specifically. As you look to balance the new initiatives that you're talking about today, the email program and the media program versus, you know, actually getting, Hi, Joe. Thanks.

As you look to balance the new initiatives that you're talking about today.

The email program and the media program versus actually getting out there.

Hi, Joe Thanks, Yeah, so from a from a G&A perspective. So we described at the at the last of.

Dean L. Schorno: Yeah, so from a GNA perspective, so we described at the last, you know, at our year-end call that we believe that we'd have a 15% year-over-year increase in OpEx. And I'd say that we're still on target with respect to that view. And then the programs that Dave describes, that's really baked into those estimates we provided. While we'll certainly continue to accelerate those programs again, it's really baked into that view that we provided earlier this year.

Year end call. We just we described the we believe that we'd have a 15% year over year increase in Opex and.

And I'd say that that's still we're still on target for with.

With respect to that view.

And then that the programs that Dave described.

Really baked into baked into those estimates, we provided well well well well certainly continue to add.

Celebrate those programs again and there its really baked into that that view that we provided earlier this year got it I appreciate the color of clarification and then.

Joseph Pantginis: I appreciate the clarification. I'm just curious if you're willing to share any details with regard to the negative impact from persistency. So obviously, you know, even from when you guys launched a month ago, how much does persistency potentially or not impact you?

I appreciate all the details regarding the weakness in first quarter and you know a lot of it makes sense. So I was just curious if you're willing to share any details with regard to any.

Negative impact from persistency. So obviously you know for even from when you guys launched you know on being able to get people to you know four months since physicians have the experience of that and be able to get to additional refill. So how much of the persistency potentially or not impacted the weakness.

David A. Santos: Dave, maybe you want to address that. Yeah, sure. Persistency hasn't changed from the end of the fourth quarter. It's still at 56% after four months. And so again, what we feel has happened is because the new year changed, you have delays in patients getting their refills and patients starting the drug. And so that is, they're still on the drug. We don't consider them discontinued; they're still on the drug persistently, but they've been delayed. And so it really isn't a function of persistency; it's more the time of the refill. I hope that makes sense. No, it certainly does.

Dave maybe you want out of drug on me.

Yeah sure Persistency Hasnt changed from the end of the fourth quarter, it's still of 56% at for banks and so again.

What what we feel has happened is because of the new year changed you have delays in patients getting their refills and patient starting drug into that.

They are still on the drug.

Don't consider them discontinued they are still on the drug persistent but they've been delayed so it really isn't a function of persistency. It's more of the time of the refill I hope that makes sense no. It certainly does it's good to hear on a just had to ask either way.

David A. Santos: And then my last question, I think it really comes down to, you might just want to answer, you know, I have to ask them, but any sort of geographical updates you can provide with regard to griffles. Sure, I'll answer what I can.

And then my last question I think really comes down to many of you you might just want to answer all of you know I have to ask them, but.

Any sort of geographical updates you can provide with regard to gryphon.

Sure I'll allow I'll answer what I can't I as you know day, both launched in the U K on Germany, and and they're looking to launch in the other territories other the other large zone.

Raul R. Rodriguez: As you know, they've launched in the UK and Germany, and they're looking to launch in other territories, the other large European countries, and they're on track to do so. But I can't give you too much guidance beyond that in terms of the timing of that, other than the products being approved throughout Europe, but individual countries then have to approve pricing and so forth. So it is a little bit of a delay; certainly, the COVID pandemic has hit Europe as hard as it hit the US, if not more so, so that's certainly causing some delays for sure.

On a P in countries and they are on track to do so I can't give you too much guidance beyond that in terms of the timing of that other than the products approved in the throughout Europe, but individual countries and then have to approve pricing and so forth. So it is a little bit of a delay on certainly the COVID-19 pandemic of Cat has hit Europe is hard to say that the.

The us if not for so so that's sort of the causing some of some delays for sure but they are on track to launch that they're excited about the opportunity, it's a great fit with their overall portfolio.

Raul R. Rodriguez: But they're on track to launch it, and they're excited about the opportunity. It's a great fit with their overall portfolio in Europe, and they look forward to making good progress. We work closely with them on the positioning of the product and sharing information on the product, and even materials they can use there. We're excited about that. You may have also seen, since you asked about partners, our partner has enrolled in the Phase 3 trial, and they will, after that's completed, file for approval in Japan.

In Europe, and and they look forward to making good progress we work closely with them and the positioning of the product in and sharing information on the product even materials. They can use there. So we're excited about that you may have seen also since you asked about partners are key say our partner role of the phase III trial and they will.

After that's completed the file for approval in Japan.

Joseph Pantginis: Got it. Thanks a lot, guys. Our final question comes from the line of Kristen Kluska with Cancer for Children. Please, submit your question. Hi, everyone.

Got it thanks, a lot guys.

Our final question comes from the line of Christian Costco with Cantor Fitzgerald, Please share with your question.

Hi, everyone. Thanks for taking my question.

Kristen Brianne Kluska: Hi everyone, thanks for taking my question. The first one is, prior to the pandemic starting and before initiating your trials in COVID-19, you were discussing the potential of bringing fostamatinib forward in another indication, so I wanted to ask how you're thinking about the short and long-term plans here, in light of some of these conditions you've shared in the past, as well as the effects you've now seen in COVID-19, which you've noted in the past could potentially be translatable to other conditions like ARDS.

The first one is prior to the pandemic starting in before initiating your trials in COVID-19, you were discussing the potential of bringing fast from that forward in another indication. So I wanted to ask how you're thinking about the shock the short and long term plans here in light of some of these conditions you've shared.

On the past as well as the effects you've now seen any COVID-19, which you've noted in the past could potentially be translatable to other conditions like a rds.

Wolfgang Dummer: I'll ask Wolfgang to also comment, but you're absolutely right, we evaluated a number of other additional indications for foster matinib. The exclusivity period, as you may know, goes to 2032, so it's still a good long way.

Thank you Christian good question.

I'll ask Wolfgang to us would come in but you're absolutely right we were.

The number of other additional indications for fast Matt in the.

Of the exclusivity period as you May know it goes through 2032, so it's still a good long ways and it's a product that is the is the sick inhibitor and frankly, the only sick inhibitor approved in and of unique package of effects on the immune system that I think is beneficial in broad number of areas beyond ITT and AIA trade.

Raul R. Rodriguez: And it's a product that has a sick inhibitor, and frankly, the only sick inhibitor approved, and a unique package of effects on the immune system that I think is beneficial in a broad number of areas beyond ITP and AIHA, both autoimmune diseases, but also other, other areas. And we're seeing that in COVID-19 hyperimmune. So this COVID opportunity really came upon us, and we're incredibly fortunate to be positioned to move Fostomatinib forward in the treatment potentially of COVID-19 hyperimmune responses.

The autoimmune diseases, but also other other areas and we're seeing that in COVID-19, hyper immune response, so there's a COVID-19 opportunity to really came upon us and where.

In the incredibly fortunate to be positioned to move fast of Matt the forward in the treatment potentially of COVID-19, hyper immune response and it opens up the opportunity as you mentioned for other areas in our D. S. From other sources other viral cause of for example, maybe other pathogens and maybe autoimmune.

Raul R. Rodriguez: And it opens up the opportunity, as you mentioned, for other areas in ARDS from other sources; other viruses, for example, maybe other pathogens, and maybe autoimmune. Unknown Executive, Yigal Nochomovitz, Raul Rodriguez, Dean Schorno, Kristen Kluska, Allison Bratzel, David Santos, Kalpit Patel, Carly Kenselaar, Raymond Furey, Raymond Furey, Richard Miller, Eun Yang, Nalin Tejavibulya, Rigel Pharmaceuticals Inc. Yeah, maybe just as you can see, the data set in COVID-19 is very compelling It's very positive. It's actually stronger than many of us would even believe is possible.

Jesus is the potential way forward.

So we're very excited about that but the opportunity is broader than that maybe what's kind of you want to comment on on anything else.

Yeah, maybe just the.

As you confuse the the dataset in COVID-19 is very compelling it's very positive it's actually.

Stronger than many of US would if you can believe it is possible. So so they're very excited about debt.

We will certainly explore and investigate how this might translate to other acute respiratory distress syndrome.

Wolfgang Dummer: So we're very excited about that, and we will certainly explore and investigate how this might translate to other acute respiratory distress syndromes. That's one option. But, as you remember correctly, last year we were also investigating other heme indications and things like chronic graft-versus-host disease, for example, or low-risk MDAs. By the way, we have two ISTs in ongoing, investigator-sponsored trials, one in graft-versus-host with encouraging early data, on Foster Martin for a Hem-Onc indication. So we certainly have that on the radar screen. Thanks.

That's one option, but as you as you remember correctly last year, we built or are investigating other hem indications and some of the things like chronic graft versus host disease for example on.

For.

Low risk India is by the way, but we have a we have two ice teas ongoing investigator sponsored trials one in graft versus host with.

Encouraging early data and we have a collaboration with the well renowned academic institution on.

On the of close to them of maybe Mike you know hemo on communications. So we certainly have debt on the radar screen.

Thank you and for chronic I T. P. In terms of the physicians, you're engaging with who are potentially interested or have switched patients in mind. How has it been your experience or understanding during the pandemic that the physicians would just feel more comfortable doing this one fully.

Kristen Brianne Kluska: Thank you. And for chronic ITP, in terms of the physicians you're engaging with who are potentially interested or have switched patients in mind, has it been your experience or understanding during this pandemic that physicians would just feel more comfortable doing this once fully back to the office and that they can monitor their patients with, you know, the normal routine visits?

Back to the office and that they can monitor their patients with you know the normal routine.

Routine visits.

Dave maybe you want to reply to that.

Sure I think that makes a lot of sense.

Because obviously, if they are able to start of new patient and see them and have them come up for it.

It is much easier but I.

Just wanted to.

Sure at the end of the day, it's about getting awareness out there we really do believe as I stated on the last couple of calls.

Since we had the B J H article, which really is our strongest evidence of efficacy.

David A. Santos: Sure, I think that makes a lot of sense. Because obviously, if they are able to start a new patient and see them and have them come back for follow-up visits, it is much easier. But I, you know, just wanted to make sure that at the end of the day, it's about getting awareness out there. We really do believe, as I've stated on the last couple of calls, since we had the BGH article, which really is our strongest evidence of efficacy.

And now we've got five year results that have been published.

And really talk about the low.

The very low.

Risk of of.

That's our embolic event.

The the kind of.

Story of top of leaf unique mechanism of action very Berry.

<unk> and <unk>.

Can provide long term durable results. This is what we have to get out there and that's why I keep talking about the more we can actually see physicians and talk to them about the drug and introduce them to the mechanism of action again repeat it to them and really talk about the waste patients can benefit from the strike to me.

David A. Santos: And now we've got five-year results that have been published that really talk about the low, the very low risk of thrombotic events. I think that the kind of benefit from this drug. To me, that's what will really help us to acquire new patients. I do think it will help as they obviously see patients. But at the end of the day, we really do believe we have a great message and a great story to bring to patients and a constantly evolving story with, as I said, a new publication that was just published last week.

That's what we're really.

Help us to acquire new patients I do think it will help as they obviously see patients but.

But at the end of the day, we really do believe we've got a great message and a great story to bring to patients.

Constantly evolving story with us they set of new publication that was it was just.

The last part.

Kristen Brianne Kluska: And then my last question, in light of the research that you've conducted looking at the opportunity over the next few years here, would you or perhaps, in collaboration with your partners, consider the opportunity outside the U.S. as well in terms of COVID-19?

Great. Thank you and then my last question in light of the research that you've conducted looking at the opportunity over the next few years here.

Would you or perhaps in collaboration with your partners consider the opportunity ex U S as well in terms of COVID-19.

Raul R. Rodriguez: Absolutely. I'll ask Dave to also comment on the opportunity in the U.S., but outside the U.S., we have partners. Griffels, our partner in Europe, is very excited about the potential COVID opportunity for fostamatin in Europe on their territory. And you know, part of their effort is hematology and hospital-based, given what they sell there. So this is a very nice fit for them.

Absolutely Alaska day to us comment on the opportunity of the U S, but outside the U S.

We have partners cripples our partner in Europe is very excited about the potential COVID-19 opportunity for for fast Imatinib in Europe in their territory and you know they are also a part of their effort is hematology and hospital based on.

Given what they sell there. So this is a very nice fit for them. So clearly that's a tremendous opportunity there. Similarly, our partner in Japan can you say is very interested in the opportunity that they have rights in Japan.

David A. Santos: So clearly, that's a tremendous opportunity there. Similarly, our partner in Japan, Kisei, is very interested in the opportunity they have right here in Japan, South Korea, China, and Taiwan, as you may know, and the tremendous potential for this data there as well. And then other territories as well, where we're looking to put partnerships in place. So the opportunity is quite sizable for COVID, addressing the COVID issue outside the U.S. territories. We'll file the EUA as soon as possible here and then work on those other territories in order.

Japan.

South Korea, China, and Taiwan, as you May know and so tremendous potential for the state out there as well and then other territories as well where we're looking at partnerships in place. So the opportunity is quite sizable for.

For the COVID-19 addressing the COVID-19 issue in the outside the U S territories.

The file the EUA as soon as possible here and then work on those other territories can sequence they've made any other comments on U S.

David A. Santos: Dave, any other comments on the U.S. market? No, I'm, you know, our look at the market is that, even though, as I said, these vaccine rates are, even if you assume very, very high vaccine rates and, you know, what we would deem basically 100% efficacy in keeping patients out of the hospital, you've still got a pretty sizable market here in the US. And so our job, should we receive an EUA, would be to make sure that, you know, clinicians know about Fostamatib and certainly know how to access it. And I think those are the kinds of things we're thinking about in terms of making sure that we do our part to help COVID patients who truly do need new therapy.

No.

Our look at the market is that even though as I said these vaccine rates or even if you assume very very high backs heat rates and you know.

What we would the basically a 100 per cent efficacy of keeping patients out of the hospital you've still got.

A pretty sizable market here in the U S and so our job should we receive.

Would be to make sure that Clint.

Clinicians know about the cost Matt.

And.

Certainly know how to access it and I think those of the kinds of things we're thinking about in terms of.

Making sure that debt, we do our part.

To help COVID-19 patients, who truly do need new therapies.

Kristen Brianne Kluska: Great. Thank you, everybody.

Great. Thank you everybody.

Operator: Thank you, Kristen. There are no further questions left at this time, and now I'd like to turn the floor back over to Mr. Raul Rodriguez for a closing remark. Well, thank you, everyone, for listening and for your questions. I appreciate that.

Thank you Christina on.

There are no further questions at this time and now I'm on.

Ill turn the floor back over to Mr. Raul Rodriguez for closing remarks.

Well. Thank you everyone for all for listening and your and your questions. I appreciate that I think of 2021 will be a very exciting year for us and we look forward to significant growth in the leasing of RTP.

Raul R. Rodriguez: I think 2021 will be a very exciting year for us, and we look forward to significant growth in Tavalisan ITP, completion of our AIHA trial enrollment, and then data after that. And this COVID-19 opportunity, I can't tell you how proud we are to potentially offer what we think is, but it will really be a valuable contributor to the treatment of hospitalized COVID patients. It's a tremendous and exciting opportunity for us and has the potential to be a sizable, sizable indication, as you saw from Dave's slides. And we look forward to filling out the pipeline behind that. So, it is an exciting year ahead.

The <unk> of our AIA trial.

Trial enrollment and then the data after that and the COVID-19 opportunity I can't tell you how proud we are to potentially offer what we think is.

But I sort of really be a valuable contributor to the treatment of COVID-19 hospitalized COVID-19 patients, it's a tremendous and exciting opportunity for us and has potential to be.

Sizable sizable indication as you saw from a day of slides and we look forward to filling up the pipeline behind that so an exciting year ahead of look forward to keeping you abreast as as we make progress. Thank you so much.

Operator: I look forward to keeping you abreast as we make progress. Thank you so much. This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.

This concludes today's teleconference. You may now disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.

Yeah.

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