Q1 2020 Earnings Call

Greetings and welcome to Rigel Pharmaceuticals Financial conference calls for the first quarter 2020 at this time all participants are they listen only mode.

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

Question and answer such and will follow a formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.

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

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

Welcome to our first quarter 2020 financial results and business update conference call.

Unknown Executive: Welcome to our first quarter 2020 financial results and business update conference call. 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, in the news and events section of our investor relations page on our website, 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 annual report on Form 10-K for the year.

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 in the news events section a.

Burn Investor Relations page on our website www Rigel dot com.

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

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

A description of these risks can be found in our annual report on form 10-K for the year ended December 31st 2019, a subsequent filings with the FCC, including our Q1 quarterly report on form 10-Q.

Unknown Executive: for the year ended December 31st, 2019, and subsequent...

Unknown Executive: Thank you for joining us on this edition of the Center for Health and Human Services. 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. At this time, I would like to turn the call over to our CEO, Raul Rodriguez.

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.

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

Thank you Dolly and thank you for joining us on our first quarter 2020 financial and business update call.

Raul R. Rodriguez: Thank you, Dolly, and thank you for joining us for our first quarter 2020 financial and business update. Also joining me on the call is Tarek Salam, our Vice President of Marketing.

Also joining me on the call is Patrick Sullivan, our vice President of marketing.

Raul R. Rodriguez: Chief Medical Officer, Wolfgang Dummer, and Dean Schorno, our CFI. First, I'd like to say that during these extraordinary times, the entire team at RIGEL hopes you and your families remain safe and healthy. Importantly, we would like to thank all of the health care workers for their selfless efforts, which are absolutely vital.

Our Chief Medical Officer Wolfgang tumor.

And to ensure our CFO.

I'd like to begin on slide five.

First I'd like to say that during these extraordinary times the entire team Mcbride your hopes you and your family's remain safe and healthy.

Importantly, we would like to thank all of the healthcare workers further selfless efforts, which are absolutely vital.

From a company perspective, our primary goal. This dog is to ensure the safety and health of our employees and patients.

Raul R. Rodriguez: From a company perspective, our primary goal at this time is to ensure the safety and health of our employees and patients. Rigel is taking actions across all of our business areas in order to continue executing on our strategy amid this challenging time. We are monitoring the impact this will have on our business going forward and will continue to adapt to the environment and provide updates as necessary.

Right. It was taking actions across all of our business areas in order to continue executing on our strategy a meat amidst this challenging times.

We are monitoring the impact this out will have on our business going forward and we'll continue to adapt to the it by your bread and provide updates as necessary.

No I want to slide six.

Roger has four key value drivers growing total lease in the U.S. RTP market capturing value into global like T. P market via collaborations.

Raul R. Rodriguez: Rigel has four key value drivers, growing Tavelis in the US ITT market, capturing value in the global ITP market via collaboration, creating and capitalizing on warm autoimmune hemolytic anemia opportunities, and expanding our pipeline of programs. Q1 of 2020 was certainly not what we imagined it would be, to say the least.

Greetings and capitalizing on warm autoimmune hemolytic anemia opportunity.

And expanding our pipeline to programs.

You want of 2020, what certainly not what we imagined it would be to say the least.

Nonetheless, we adapted to our environment transitions to a virtual platforms and made important progress.

Raul R. Rodriguez: Nonetheless, we adapted to our environment, transitioned to virtual platforms, and made important progress. In the recent quarter, we continued to grow sales on a year-over-year basis, reporting a 57% increase compared to the first quarter of 2019. We are very pleased with this given everything that is going on externally. This is a testament to the high quality commercial organization we have in place as well as the highly differentiated and effective product we provide. In the global market, we're excited to have received approval for Fosdermatinib in Europe this past January. It will be marketed under the brand name Tablez by our partner, Griffin. The label we received is very attractive and exactly what we were looking for.

In the recently corridor, we continued to grow sales at mid year over year basis reporting a 57% increase compared to the first quarter of 2019.

We're very pleased with this given everything that's going on externally. This is a testament to the high quality commercial organization, we have in place as well as the highly differentiated and it back their product we provide.

In the global market. We're excited to have received approval for Fostamatinib in Europe. This past January.

It won't be marketed under the brand name publicity.

Yeah, our partner Quibbles.

Illegal we received is very attractive and exactly what we were looking for its broad and allows us to compete effectively in Europe.

Raul R. Rodriguez: Broad, and allows us to compete effectively in Europe. With this approval, we recognized $43.1 million of revenue during the quarter, which included a $20 million milestone that we received in February. We look forward to Griffiths making our product available to patients, which we expect them to do this quarter. The commercial opportunity is in warm autoimmune hemolytic anemia, which we believe is an even greater opportunity. A.I.H.A. is another autoimmune disease, like I.T.P., where the body produces antibodies against a hematologic cell. In this case, red blood.

With this approval, we recognize 43.1 million of revenue during the quarter.

Which included a 20 million dollar milestone that we received in February.

We look forward to Griffith, it's making our product available to patients, which we expect them to do this quarter.

Our next potential commercial opportunity is in warm autoimmune hemolytic anemia, which we believe as an even larger opportunity for rigel.

Actually it's another autoimmune disease like RCP, where the body produces antibodies against the hematologic cell type in this case red blood cells.

Raul R. Rodriguez: There's a real unmet need for these patients, given that there are no approved products for this indication. And based on the progress we've made to date, we are in a position to potentially be the first product on the market. We have generated encouraging data from our phase 2 trial of Cavalese and warm autoimmune hemolytic anemia, giving us the confidence that we have to move forward in our phase 3 trial. We have opened over 80 sites across 22 countries for this phase III trial today. We have randomized 41 patients, and we are making very good progress prior to the impact of recent events. Dr. Wolfgang will provide an update and also review our ongoing interactions with the FDA in just a few minutes.

There's a real unmet need for these patients given that there's no approved products for this indication and based on the progress was made to date, we are in a position to potentially be the first product on the market.

We have generated encouraging data home our phase two trial of probably said warm autoimmune hemolytic anemia, given us the confidence that we have to move forward in our phase three trial.

We have opened up over 80 sites across 22 countries for this phase three trial to date.

We have randomize 41 in patients and we are making very good product, we're making very good progress prior to the impact of recent events.

Sure Wolfcamp book to provide an update and also review our ongoing interactions with the FDA and just a few minutes.

Raul R. Rodriguez: Lastly, we are very excited about the further development that is taking place in all our In addition to A.I., we are exploring other potential opportunities for tabloids, one of which is in the treatment of COVID-19 pneumonia and related conditions. Wolfgang will discuss his rationale in his, Our RIP-1 and our IRAC-1-4 inhibitors, PERC, are in Phase 1 trials, and we are very excited about the potential of both of these animals. IREC and RIP are two of the most attractive immune targets in biopharmaceuticals today.

Lastly, we're very excited about further development that is taking place and all our programs in addition to <unk>.

We are exploring other potential opportunities for top Elise wonder, which isn't the treatment of covert 19 in pneumonia and related conditions.

Wolfgang will discuss this rationale in his section.

Our reported in our Iraq, one for inhibitors perk are in phase one trials and we are very excited for the potential of both of these assets.

I reckon Rip are two of the most attractive immune targets and biopharmaceutical stay and based on our early data our molecules have demonstrated characteristics. It gives us a lot of optimism for their potential.

Raul R. Rodriguez: And based on our early data, our molecules have demonstrated characteristics that give us a lot of optimism for their potential. We continue to make progress in our discussions to secure a co-development and co-promotion agreement for one or both of these, and we believe we'll be able to do so by year end. What's really important at this time is that we have a solid finance, and we have continued to strengthen by adding $30 million in cash from a combination of a milestone payment from our partner, Griffels, and the use of our debt facility from Michigan. Dean will discuss this a bit later in the presentation. Moving on to slide seven.

We continue to make progress not discussions to secure a co development and Copromotion agreement for one or both of these assets.

And we believe we'll be able to do so by yearend.

Especially important at this time is that we have a solid financial position and we have continued to strengthen our you're adding 30 million in cash from a combination of milestone payment for a partner cripples and they use of our debt facility from mid cap.

He will discuss this a bit later in the presentation.

Moving on slide seven.

Raul R. Rodriguez: We are excited about these key value drivers because they address areas of important medical needs and are major market opportunities. We are well positioned to access capital across these areas, even in this environment. ITP is a 1.1 billion dollar market and growing in the U.S. Outside the U.S., the ITP market is about 900 million. We think that warm autoimmune hemolytic anemia has the potential to be a billion-dollar market investment. Similar to the current size of the ITP market, and our pipeline continues to offer Rigel tremendous opportunities for business development activities and clinical trials in the near future, near term, and in the future. With that, I'll turn the call over to Tariq.

We are excited about these key value drivers because they address the areas of important medical need and our major market opportunity, we are well positioned to capital Lexus across these areas even in this environment.

I keep he is a 1.1 billion dollar market and growing in the U.S.

Outside the U.S. I keep market is about 900 million.

We think that warm autoimmune hemolytic anemia has potential to be a billion dollar marketing the U.S. similar to the current size is the RTP market.

And our pipeline continues to offer rigel tremendous opportunities for business development activities and clinical trials in the near future near term and in the future.

With that I'll turn the call over to talked park.

Tarek Salam: Thank you, Raul. Our current commercial efforts are centered around our first marketed product, Tavalease, which, as you see on slide 9, is a kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. Let's move to slide 10. I'd like to further elaborate on our first quarter performance that Raul highlighted earlier. We generated net product sales of $12.7 million, which was an increase of 57% compared to $8.1 million in the first quarter of last year. There were 1,398 bottles shipped to patients and clinics during the quarter, which excludes any change in bottles remaining in distribution channels, which Dean will review in his update.

Thank you Raul.

Our current commercial efforts are centered around our first marketed product Tbilisi, which as you see on slide nine is a kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic guy TP hadn't insufficient response to a previous treat.

Let's move to slide 10.

I'd like to further elaborate on our first quarter performance that well highlighted earlier.

We generated net product sales to 12.7 billion, which was an increase of 57% compared to 8.1 million in the first quarter of last year.

There were 1390 bottles shipped to patients and clinics during the quarter.

Which excludes any change in bottles remaining in distribution channels, which again will review in his update.

Tarek Salam: This was encouraging given the typical headwinds pharmaceutical companies face in the first quarter, particularly for oral specialty products, which are created by insurance reauthorizations, Patient Starting New Plans, and Medicare Reset. What was, of course, atypical for the quarter was the rapid outbreak of COVID-19. Leading up to the month of March, we were excited to get out in front of our customers with our recent clinical data and second-line patients, which I'll discuss in a few minutes, and deliver on our strategic priorities for the year, despite these typical first quarter headwinds. But then, as we all know, the current pandemic quickly changed the dynamic of how we all work and interact with one another. However, we did see an uptick in March that has persisted through April, driven by a combination of both refills and new patient starts. Additionally, our persistency rate remained in the 54% range for the quarter. All of these are important indicators of future growth. All said, we are pleased with the progress and foundation we have in place. However, we certainly could not have anticipated COVID-19 occurring when it did.

This was encouraging given the typical headwinds pharmaceutical companies face in the first quarter.

Particularly for oral specialty products.

Which are created by insurance reauthorization.

Patients starting to plans and Medicare resets.

What was of course atypical for the quarter, what's the rapid outbreak of Cobot 19.

Leading up to the month of March we were excited to get out in front of our customers with our recent clinical data in second line patients, which I'll discuss a few minutes.

And deliver on our strategic priorities for the year. Despite these typical first quarter headwinds.

But then as we all know the current pandemic quickly change the dynamic of how we all work and interact with one another.

However, we did see an uptick in March that has persisted through April.

Given by a combination of both refills and new patient starts.

Additionally, our persistency rate remained in the 54% range for the quarter.

All of these important indicators of future growth.

All said, we're pleased with the progress and foundation, we have in place.

Well, we certainly could not anticipated cobot 19 occurring when it did.

Tarek Salam: Let me share with you what we are doing in this new environment to support our health care providers, their ITP patients, and the Tata Lease business, and how we believe that we will exit this period of challenge well-positioned. Moving on to slide 11. I'd like to take a few moments to provide you with an assessment of the health care environment our customers are facing during this pandemic. A majority of our physician customers and clinics have restricted access to or have fully shut down to drug company sales. In fact, many clinics and institutions are only seeing critically ill patients.

Let me share with you what we're doing in this new environment to support our health care providers.

<unk> patients and the total lease business and how we believed that we exit this period of challenge well positioned.

Moving onto at 11.

I'd like to take a few moments to provide you with an assessment of the health care environment, our customers are facing joined us pandemic.

A majority of our physician customers and clinics have resist excuse me rich restricted access or a fully shut down to drug company sales teams.

In fact, many clinics in institutions are only seeing critically ill patients.

Tarek Salam: They have even begun to triage their malignant disease patients that do not have an imminent health risk or an acute need and are asking them to remain at home and wait to schedule a follow-up appointment. This is obviously an incredibly challenging environment for our providers, their patients, and, of course, for us to attempt to conduct business as usual. Fortunately, we're in an age in which virtual technology is accessible and easy to utilize. Virtual engagements will be a necessity for any measure of success in sales for the foreseeable future, and we are seeing offices increasing their telemedicine capability. As a relatively small and nimble organization, we were able to quickly adjust by making many of our in-person activities virtual, including one-on-one physician conversations, in-services to support new prescribers and their staff, as well as providing existing customers with ongoing support remotely. These engagements have been well-received, and we will continue to optimize their effectiveness. Additional feedback from our customers is that given the current shelter-in-place orders throughout the country, having an oral option is certainly perceived as a potential benefit.

They have even begun to treat I wish there malignant disease patients that do not have imminent health risk or an acute need and are asking them to remain at home at wait to schedule a follow up appointment.

This is obviously, an incredibly challenging environment for providers their patients and of course for us to attempt to conduct business as usual.

Fortunately, we're in an agent, which virtual technology is accessible and easy to utilize.

Virtual engagements bar a necessity for any measure of success in sales for the foreseeable future.

And we're seeing office is increasing their telemedicine capabilities.

As a relatively small nimble organization, we were able to quickly adjust by making many of our in person activities virtual including one on one position conversations in services to support new prescribers and their staff as well as providing existing customers with ongoing support remotely.

These engagements have been well received and we will continue to optimize their effectiveness.

Some additional feedback from our customers is that given the current shelter in place orders throughout the country, having an oral option is certainly perceived as a potential benefit.

Tarek Salam: Recently, we launched a physician product sampling program. The objectives of the program are to encourage physician trial of tablilis and assist in patient identification, and we're seeing an increased utilization of our sampling program, which we have been able to facilitate remotely. We're extremely excited to have a program in place to help physicians and patients access tablilis while limiting their risk of exposure to COVID-19 with fewer office visits.

Recently, we launched a physician product sampling program.

The objectives of the program or to encourage physician trial of top beliefs and assistant patient identification.

And we're seeing and seeing an increased utilization of our sampling program, which we have been able to facilitate remotely.

We're extremely excited to have a program in place to help physicians and patients access cavalese, while limiting the risk of exposure to co lead cobot 19 with fewer office visits.

Turning to slide 12.

Tarek Salam: I'd like to share why we believe that we're poised for success once the current environmental situation normalizes. As a reminder, one of our key priorities for 2020 is increasing the utilization of Tavalese in earlier lines of therapy and accessing larger patient pools, represented by the chart on the left side of the slide. We feel that the second line data analysis, summarized on the right side of the slide, is critical in our ability to execute on that strategy. As a reminder, this is a retrospective analysis of patients in our Phase 3 clinical trials that received TAVALIS as a second-line therapy. And of these patients, 78% achieved a response. This is a similar response seen by other agents in this setting. This data was presented at the American Society of Hematology Conference in December of 2019. We then trained our teams and launched new materials in mid to late February. So awareness of the second line data is quite low.

I'd like to share why we believe that we're poised for success once the current environmental situation normalizes.

As a reminder, one of our key priorities for 2020 is increasing the utilization of Cavalese in earlier lines of therapy and accessing larger patient pools represented by the chart on the left side of the slide.

We feel that the second line data analysis summarized on the right side of the slide is critical in our ability to execute on that strategy.

As a reminder, this is a retrospective analysis of patients in our phase three clinical trials that received probably says a second line therapy.

And of these patients 78% achieved a response.

Because there's a similar response seen by other agents in the setting.

Okay.

This data was presented at the American Society of Hematology Conference in December of 2019, We then trained our teams and watch new materials in mid to late February So awareness of the second line data is quite low.

Well our field teams now have these materials in our sharing them virtually.

As you can imagine they're excited to get out in front of their customers more broadly with this new messaging.

Tarek Salam: Well, our field teams now have these materials and are sharing them virtually. As you can imagine, they're excited to get out in front of their customers more broadly with this new messaging. And once they're fully deployed, this truly represents an opportunity to share with healthcare providers a new perspective on Tavalisse's clinical utility and further support for STORI in the earlier line treatment setting as the environmental situation normalizes. Wolfgang?

And once they're fully deployed.

This truly represents an opportunity to share with health care providers, a new perspective on top of leases clinical utility and further supports for story and the earlier line treatment setting as the environmental situation normalizes.

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

Thank you toric or good afternoon, everybody I would begin on slide 14.

As you know supposed to map is currently in an ongoing phase three pivotal trial in warm old immune hemolytic anemia.

Here's an update on our progress and how we're adapting a in this current environment.

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

Currently we have 41 patients randomized into the study, which is nearly half of our target enrollment number we had very good recruiting momentum until early March when the koby of 19 pandemic spread widely and clinical trials types begin to temporarily postponed screening.

Wolfgang Dummer: I'll begin on slide 14. As you know, fostamatinib is currently in an ongoing phase 3 pivotal trial in warm, all-immune hemolytic anemia. Here's an update on our progress and how we're adapting in this current environment. Currently, we have 41 patients randomized into the study, which is nearly half of our target enrollment number. We had very good recruiting momentum until early March when the COVID-19 pandemic spread widely, and clinical trial sites began to temporarily postpone screening. While this is effectively delaying enrollment for now, I'd like to emphasize the importance of the established operational foundation of our trial. We have over 80 trial sites in 22 countries that remain active. Hence, as soon as the COVID-19 situation normalizes, we should regain momentum rather quickly and efficiently. And since some countries are likely to normalize quicker than others, we can restart enrollment on a country-by-country basis, which will provide a competitive enrollment advantage.

Why this is effectively delaying enrollment for now I'd like to emphasize the importance already established operational foundation of our trial.

Oh, we have over 80, a trial sites and 22 countries that remain active.

Hence I assume it's the Cobiz 19 situation normalizes, we shoot regained momentum rather quickly and efficiently.

And since some countries are likely to normalize quicker than others, we can restart enrollment on our country by country basis, which grew provides a competitive enrollment advantage.

During the border. We also had productive conversations with the FDA about the program.

As a reminder, the try this placebo controlled with wonder woman randomization to close them out and they put placebo well originally the sample size was claim to be 80 patients. We have increased the trial site glides between 90 patients, which it's incremental powering the study and could meet to help mitigate.

Wolfgang Dummer: During the quarter, we also had productive conversations with the FDA about the program. As a reminder, the trial is placebo-controlled with a one-to-one randomization to false tamatinib or placebo. Originally, the sample size was planned to be 80 patients, but we have increased the trial size slightly to 90 patients, which adds incremental powering to the study and could help mitigate any potential missing data caused by COVID-19. We're still working with the FDA on finalizing the most appropriate durability measure. Since there is no drug approved for ARHA and we have the only ARHA trial in a pivotal phase 3, we are setting the standards and working with the FDA to establish this durability criterion. Turning to slide 15.

Any potential missing data caused by Qubits 19.

We're still working with the if they're not on finalizing the most appropriate your ability to measure.

Since there is no drug approved <unk> and we have the only a trial you know pivotal phase three we're setting the standards and the Brooklyn safety to establishing this at your ability criterion.

Turning to slide 15.

Like others in the industry Rigel hes been forced to rapidly adopt a phase three clinical trial conduct due to the current Cobiz 19 pandemic.

Yes. They recently provided guidance for the conduct of the trial during cold with my team, which provides some flexibility that we are utilizing.

Wolfgang Dummer: Like others in the industry, Rigel has been forced to rapidly adapt our phase 3 clinical trial conduct due to the current COVID-19 pandemic. The FDA recently provided guidance for the conduct of a trial during COVID-19, which provides some flexibility that we are utilizing. For example, patients can get blood draws locally from their primary care physicians and have them analyzed by their local lab. Or some site visits can be replaced by virtual visits to collect basic safety information so that patients' risk of exposure to the virus can be kept as small as possible. We also maintain a laser-sharp focus on collecting all obtainable data in order to maintain a complete and robust set for the patients that are already in the study. Regarding enrollment completion, right now, there is a COVID-19-related delay. At this time, we cannot give clear guidance on what the delay will be exactly.

For example, a patients can get blood draws locally from that primary care physicians and help them analyzed the local ramp or sums site visits can be replaced by virtue of visits to collect basic safety information so that patient risk of expose it to the virus can be kept a small as possible.

We also maintained that leaves a sharp focus on collecting all obtainable data or in order to maintain a complete and robust fit for the.

For the patient that already in the study.

Regarding enrollment completion right now, there's a cobiz 19 related to delay.

This time, we cannot give clear guidance on what to do they would be exactly we will provide updates as sick mobikwik 19 impact becomes more certain.

Well, there's I have you alluded to earlier this enrollment pause should not impact our goal to have to first treatment to markets or <unk> eat with all its first mover advantage is if anything or we could potentially be extend though enrollment lead given the large numbers you are in the geographic <unk> range of hours.

Wolfgang Dummer: We will provide updates as the global COVID-19 impact becomes more certain. But as I have alluded to earlier, this enrollment pause should not impact our goal to have the first treatment to market for AIHE with all its first mover advantages. In fact, we could potentially extend our enrollment lead given the large numbers in the geographical range of our sites that remain active.

Sites that remain active.

Slide 16.

Moving to a additional pipeline options beyond H E. U C. Cobiz 19 on this slide and I will speak to the scientific rationale for both of them up and they've been potentially activities included 19 in a in a little while.

Wolfgang Dummer: Slide 16. Moving to additional pipeline options beyond AIHA, you see COVID-19 on this slide, and I will speak to the scientific rationale for foster matinib and potential activities in COVID-19 in a little while. Given the broad potential for fostamatin in our sick inhibition program, we considered a large pool of indications, and we have narrowed the search down to the most attractive opportunities, which we plan to pursue. Executing on an additional label indication for fostamatinib will enable us to take full advantage of the exclusivity for this molecule, which is expected to be into 2032.

Given the broad potential proposed them up and even in our six inhibition program. We consider the large school up indications and we have narrowed to search down to the most attractive opportunities, which we plan to pursue.

Executing on an additional label indication for close to map and they will enable us to take full advantage of the exclusivity put this molecule, which is expected to be into 2032.

In addition to post American it our Iraq, one inhibitor, the only inhibitor molecule, both eirik ones and Eirik floor pathways.

Wolfgang Dummer: In addition to fostamatinib, our IRAG1 inhibitor, the only inhibitor molecule of both IRAG1 and IRAG4 pathways, continues to progress in the program and remains in good position. In preclinical studies, it has shown to block inflammatory cytokine production in response to TLR and IL-1 receptor family signaling. And a phase one human healthy volunteer study achieved its proof of mechanism and demonstrated favorable PK characteristics. Finally, we recently completed the multiple ascending dose stage of our Phase I study with our systemic RIP-1 inhibitor. Importantly, we have identified a dose range that is safe and is well within expected clinical efficacy. We confirmed the 14-hour half-life for these doses, which is quite significant, as it should allow for a once-a-day dose.

Continues to progress in the program and remains in good position.

In preclinical studies it has shown to block inflammatory cytokine production response to T. R and I have a one receptor family signaling.

And a phase one human healthy volunteer study.

Achieved its proof of mechanism and demonstrate its favorable a PK characteristics.

Finally, we recently completed the multiple ascending dose stage Apollo phase one study, but those systemic group one inhibitor.

Importantly, we have identified the dose range that is safe and is well within expected clinical efficacy.

We confirmed the 14 hour half life for these doses, which is quite significant as it should allow for once a day dosing.

And as mentioned previously we also plan to identify a rip inhibitors see an its molecule in the near future to move into the clinic as well.

Wolfgang Dummer: And as mentioned previously, we also plan to identify a RIP inhibitor CNS molecule in the near future to move into the clinic as well. Now, let me shift gears and briefly share our considerations for the use of prostamatinib in the treatment of COVID-19 patients. We truly believe there is a compelling scientific rationale for the drug to have benefit in treating COVID-19 pneumonia, as well as associated acute respiratory distress syndrome. I will take you through that. Slide 17.

Now, let me shift skews in briefly share all considerations for the use of course, the mats and had been the treatment of cobot 19 patients.

We truly believe goes the compelling scientific rationale for the drug so have benefit in treating cobot 19 pneumonia as well as associated acute respiratory distress syndrome, let me take you through that.

Slide 17.

As you May know pneumonia is going up the most severe complications associated with Cobiz 19 severe cases can progress to he already is which requires invasive ventilation due to low blood oxygen saturation and frequently to death.

Wolfgang Dummer: As you may know, pneumonia is one of the most severe complications associated with COVID-19. Severe cases can progress to ARDS, which requires invasive ventilation due to low blood oxygen saturation and frequently leads to death. Interestingly, this rapid progression often happens when the immune system has already begun to make antibodies against SARS-CoV-2, and the viral load actually decreases. That means that the immune system causes the severe pathology, not just the virus. The SICK pathway is involved in multiple mechanisms, as illustrated on this somewhat simplified slide. So look at the image on the right, please, and I'll walk you through it. So if you look at the virus particle, in the early stages of infection, the replicating virus causes lung epithelial cell destruction and the release of so-called damage-associated molecular patterns, or DAMPs, and pathogen-associated molecular patterns, PAMPs, which bind to C-lectin receptors, so-called CLRs. Signaling through CLRs can lead to excessive inflammatory cytokine release and All these events can damage the lungs and also other organs such as the kidneys and the heart.

Interestingly this rapid progression often happens when the immune system has already begun to make antibodies against sort of Scooby tool and the viral load actually decreases.

That means they really didn't immune system causes the C via pathology not just the virus.

Pathway is involved in multiple mechanisms as illustrated on this a somewhat simply sorry slide.

So look at the image on the rights. Please.

And I walk you through this so you can look at the virus politics him in the early stages oak infection. The replicating virus causes lung it'd be siloed, so destruction and release of so called damage associated molecular pattern or vamps and passive Jim associated multicoloured that I'm older.

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Each find to see lectin receptos, so close here the ours.

Signaling through steel ours can lead to access inflammatory cytokine release, and Coagulopathy from vascular endothelial cells and two massive neutrophils activation and cytotoxicity by a process called Nato's is.

All these events can damage to alum and also other organs.

Such as the kidneys and the heart.

Wolfgang Dummer: Sick Inhibition with Clostamatinib can reduce this highly inflammatory process. Now, if you look towards the left side of the image, you can see the second main mechanism for a hyperreactive immune system. As a response to viral infection, our immune systems begin to make anti-SARS-CoV-2 antibodies, and these antibodies find the virus and form immune complexes with the virus, which then binds to FC-gamma receptor-expressing cells such as macrophages, dendritic cells, and monocytes. And that can, in some patients, induce excessive release of inflammatory cytokines such as IL-1, beta, IL-6, and IL-8. So here, too, cytokine inhibition with Clostamacinib can ameliorate this resulting cytokine storm and prevent organ damage. Ostematinib is the only approved sick inhibitor that may interfere with the pathology of COVID-19 at multiple points through multiple cell types and could therefore work in COVID-19 related organ damage, pneumonia, and ARDS of viral or also other etiologies.

Sick inhibition with most of them out and it can reduce this highly inflammatory process.

Now if you.

It looks to us the list side of the Mitch you can see the thinking main ER mechanism for a hyper reactive immune system.

And the response to viral infection or our immune systems, beginning to make empty source koby to antibodies.

And these antibodies or find the virus inform immune complexes with the virus, which then binds to FC gamma receptor expressing cells, such as macrophages dendritic cells and monocytes and backed him in some patients use excessive release also inflammatory cytokine such as I have beta.

Six entirely.

So here too sick inhibition of of course, the map that Kim I mean, ameliorates, this resulting cytokine storm and prevent organ damage.

Most of that's maybe it's the only approved syk inhibitor that might interfere with the pathology of Cobiz main team at multiple points through multiple so types and could therefore, working koby banking related organ damage pneumonia and your idea so viral well also update geology.

Now this is not entirely new concept as we do have preclinical data from a model of your ideas.

Wolfgang Dummer: Now this is not an entirely new concept, as we do have preclinical data from a model of ARDS. On Friday, June... Here is an executive summary of those mouse experiments. Here, R406 is the active metabolite of FOSTA used in this model and essentially the same as FOSTA. On the left, you see the histology of lung tissue under four different circumstances. On the left, you see healthy lung tissue with clear alveoli where transport of oxygen into the blood happens. On the right, you see the same thing when only fost matinib is administered with no negative impact on the lung. But looking at the lower left, you see acute respiratory distress syndrome induced by LPS, which led to massive inflammation, lots of fluid and cell debris in the alveoli, making oxygenation of the blood different or insufficient. On the lower right, you can see that fostamatinib had a clear beneficial effect on this pathology. And not surprisingly, as depicted in the panel on the right, this led to the survival of the mice with ARDS that were treated with Forstermatt.

On slide 18.

You see an executive summary of those mouse experiments here or four or six is the active metabolite also used in this model and essentially the same as possible.

On the last you see the histology of lung tissue on the fourth different circumstances.

I felt if you see healthy lung tissue with clear Oh, do you like where train port of oxygen into the blood happens.

On the top right you see the same thing when only most of them up and it is administered with no when they get to negative impact on the long.

But looking at the lower list you see acute respiratory distress syndrome, and used by L.P.S., which led to massive inflammation lots of fluid and third degree in the alveoli, making oxygenation, all the blood befriend or insufficient.

On the lower right you can see that forced them up and they pay their clear beneficent you pick on this pathology.

And not surprisingly as depicted on the panel on the writes a this lets true survival optimized with a already is that were treated with forced them up and it.

So what are we going to do with all of this we are currently seriously contemplating could get to throw out into the clinic in one form or another.

Wolfgang Dummer: So what are we gonna do with all of this? We are currently seriously contemplating getting the drug into the clinic in one form or another. That could mean providing post-traumatic care to some hospitals to support one or more investigator-sponsored trials to generate initial data. It could mean all the way to potentially a rights-sponsored clinical trial. We will keep you posted. With that, I'll hand over to Dean for a review of the financials. Dean

That could mean, providing close them up and they took him hospitals to support one or more investigator sponsored trials to generate initial data. It could mean, all the way to potentially a rights with sponsored clinical trial.

We will keep you posted.

With that I'll hand over to Dean.

For a review of the financials dim.

Thank you Okay I'm on slide 20 for the first quarter 2020, we shipped 1393 bottles to our specialty distributors, we shipped 1398 bottles to patients to clinics, which is comparable to the fourth quarter, where we shipped 1422 bottles.

Dean L. Schorno: Thank you, Wolfgang. I'm on slide 20. For the first quarter of 2020, we shipped 1,393 bottles to our specialty distributors. We shipped 1,398 bottles to patients at clinics, which is comparable to the fourth quarter, when we shipped 1,422 bottles to patients at clinics. As in the prior year, we did see typical first-quarter reimbursement issues, such as the resetting of co-pays and the Medicare donut hole.

For patients to clinics.

During the prior year, we did see typical first quarter reimbursement issues, such as the resetting of Copays and the Medicare Donut hole incrementally we did start to see the effects of Kobin 19 in the latter part of the quarter.

Dean L. Schorno: Incrementally, we did start to see the effects of COVID-19 in the latter part of the quarter. Also, during the quarter, and for the first time, we saw a five-bottle reduction in bottles that remained in our distribution channels, resulting in a total of 591 bottles at the end of the quarter. We reported net product sales from Tavalisse of $12.7 million, a 57% increase compared to the first quarter of 2019. Our net product sales from Tavaleets will record a net of estimated discounts, chargebacks, rebates, returns, co-pay assistance, and other allowances of $2.7 million. Our gross-to-net adjustment, which is approximately 17.5% of gross product sales.

Also during a quarter and for the first time, we saw five bottle reduction in bottles that remained in our distribution channels, resulting in a total of 591 bottles at the ended the quarter.

We reported net product sales and probably a $12.7 million, a 57% increase compared to the first quarter of 2019.

Our net product sales and Tom Louise were recorded net of estimated discounts Chargebacks rebates returns co pay assistance and other allowances of $2.7 million, our gross to net adjustment, which is approximately 17.5% of gross product sales.

Dean L. Schorno: We currently expect our growth to net adjustment to remain in the 18 to 19% range throughout 2020. In the first quarter, we did see a sequential reduction in net product sales resulting primarily from the changes in the bottles remaining in our distribution channels and to a lesser extent to the impact of COVID-19 in the latter part of the quarter. Specifically, in the fourth quarter of 2019, we saw a 96-bottle increase in bottles remaining in our distribution channels compared to a five-bottle reduction in the first quarter of 2020. The effective change in bottles remaining in our distribution channels was approximately $1 million when comparing the change in the fourth quarter of 2019 to the first quarter of 2020. Before we move on from net product sales, let me comment briefly on our expectations for the second quarter of 2020.

We currently expect our gross to net adjustment to remain in the 18% to 19% range throughout 2020.

In the first quarter, we did see a sequential reduction in net product sales, resulting primarily from the changes.

In the bottles remaining in our distribution channels and to a lesser extent to the impact of Carbonite team in the latter part of the quarter.

Typically in the fourth quarter 2019, we saw 96, Bob <unk> increase in bottles remaining in our distribution channels compared to a five bottle reduction in the first quarter of 2020 effective this change in bottles remaining in our distribution channels was approximately $1 million.

When comparing the change in the fourth quarter of 2019 to the first quarter of 2020.

Before we move on from net product sales, let me comment briefly on our expectations for the second quarter 2020.

Dean L. Schorno: While we would have expected to move past the seasonality of the first quarter caused by the reimbursement issues that we discussed and would have anticipated accelerated sequential growth like we saw in Q2 of 2019, the impact of COVID-19 on our business that started in the latter part of the first quarter continues and remains uncertain. As Tariq highlighted, we've made great strides in optimizing our ability to access our physician community remotely and to provide the many patients suffering from chronic ITP in the U.S. with access to Tavoli. Once the significant impact and restrictions caused by COVID-19 are behind us, and the future begins to normalize, we expect to see continued strength and growth in our business. Currently, our long-term view of the opportunity for Tavolese remains unchanged.

While we would've expected to move past the seasonality of the first quarter caused by the reimbursement issues that we discussed and would've anticipated accelerated sequential growth like we saw in Q2 of 2019 the impact of Kogan 19 in our business that started in the latter part of the first quarter continues and.

Remains uncertain.

As Tarek highlighted we've made great strides and optimizing our ability to access our physician community remotely and to provide the many patients suffering from chronic therapy in the U.S. with access to top always.

What's the significant impact and restrictions caused by Cobra 19 are behind us and the future begins to normalize we expect to see continued strength and growth in our business currently our long term view of the opportunity for top always remains unchanged.

Dean L. Schorno: On to the next slide. In addition to net product sales, Rigel's contract revenues from collaborations were $43.1 million for the three-month end of March 31, 2020. As a reminder, during the quarter, we announced that we received European Committee approval of our MAA for Fostamatinib for the treatment of chronic ITP in Europe. With this approval, the company received a $20 million nonrefundable payment from Grifols, which is composed of a $17.5 million milestone payment and a $2.5 million creditable advanced royalty payment. In addition, $25 million of the $30 million upfront payment that we received from Griffles in Q1 of 2019, which had been previously deferred, will no longer be repayable by us to Griffles. Given this information, as well as the performance of certain research and development services, we recognize approximately $43.1 million as collaboration revenues in the first quarter of 2020.

Under the next slide.

In addition in net product sales rise as contract revenues from collaborations was $43.1 million for the three months ended March 30, Onest 2020.

As a reminder, during the quarter, we announced that we received European Committee approval of our EMEA had for Fostamatinib for the treatment of chronic high Cupid in Europe with this approval of the company received a 20 million dollar nonrefundable payment from referrals, which is composed of a 17.5 million dollar milestone payment.

It had a 2.5 million dollar creditable advanced royalty payment.

In addition, $25 million of that 30 million dollar upfront payment that we received from referrals in Q1 of 2019, which had been previously deferred will no longer be repayable bias to gribbles.

Given this information as well as the performance of certain research and development services, we recognized approximately $43.1 million as collaboration revenues in the first quarter of 2020.

The remaining deferral them out of $2.2 million will be recognized as revenue as we complete certain research and development activities, mainly related to our the conduct of our auto immune hemolytic anemia phase three clinical trials.

Dean L. Schorno: The remaining deferral amount of $2.2 million will be recognized as revenue as we complete certain research and development activities, mainly related to the conduct of our autoimmune hemolytic anemia phase three clinical trials. Moving on to cost and expenses. Our cost of product sales was approximately $155,000 for the first quarter of 2020. Total cost and expenses were $34.7 million in the first quarter of 2020 versus $31 million in the first quarter of 2019. The increase in total costs and expenses was primarily due to third-party costs related to Rides' ongoing pivotal Phase III study in warm autoimmune hemolytic anemia, research and development costs related to other clinical programs, and personnel-related costs, partially offset by stock-based compensation expenses. As we look towards 2020, we continue to expect our total cost and expenses to increase by approximately 15 to 20% as compared to 2019, as we continue our commercial expansion and further our research and development

Moving on to cost and expenses our cost of product sales was approximately $155000 for the first quarter 2020.

Total cost and expenses were $34.7 million in the first quarter of 2020 versus $31 million first quarter of 2000 matching.

The increase in total cost and expenses was primarily due to third party costs related to Rogers ongoing pivotal phase three study in warm autoimmune hemolytic anemia research and development costs related to other clinical programs and personnel related costs, partially offset by stock based compensation expense.

We look towards 2020, we continue to expect our total cost and expenses to increase by approximately 15% to 20% as compared to 2019 as we continue our commercial expansion and further our research and development pipeline.

We ended the quarter with cash and short term investments of approximately $95.9 million incrementally we accessed the second $10 million traunch from our 60 million dollar term loan facility with Midcap financial which received on May onest.

The facility provides the company with access to an additional $40 million, which is subject to an achievement of certain conditions.

Roger currently has sufficient supply of top always tablets and drug substance to meet the needs of our U.S. sites, you pick commercial business as well as our collaborative partners and clinical trials worldwide.

Dean L. Schorno: We ended the quarter with cash and short-term investments of approximately $95.9 million. Incrementally, we accessed the second $10 million tranche from our $60 million term loan facility with MidCap Financial, which we received on May 1st. The facility provides the company with access to an additional $40 million, which is subject to the achievement of certain conditions. Rigel currently has a sufficient supply of tablets and drug substances to meet the needs of our USITP commercial business, as well as our collaborative partners in clinical trials worldwide. Finally, I'd like to say that we will continue to undertake efforts to prevent or minimize disruptions to our business and operations while monitoring for new developments related to the evolving COVID-19 pandemic. At this time, we don't yet know the full impact of such disruptions on our business, operations, or financial condition. With that, I'd like to turn the call back over to Raul.

Finally, I'd like to say that we will continue to undertake efforts to prevent or minimize disruptions to our business. It operations, what monitoring for new developments related to the evolving coded 19 pandemic at this time, we don't yet know the full impact of such disruptions on our business operations.

So condition.

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

Thank you deem.

As you can see but a coke Nike Devon has had an impact varying degrees on all areas of the business.

But what we are trying to achieve has not soon.

There will be unavoidable I know I'm article impact on our business in the short term.

But fundamentally we remain on track.

This was driven by the resilience and focus of our employees and their commitment to our cousins.

We will continue to grow top of these in the U.S. I TP market.

Using virtual engagements to mix it across all these vehicles we use.

We are excited about the use of top at least in earlier lines of therapy and to take that that we have to support this position.

Similarly, we look forward to European patients suffer from back to be also having access to top less [noise].

Raul R. Rodriguez: Thank you, Dean.

And and will support our excellent partner crystals in their efforts.

Raul R. Rodriguez: As you can see, the COVID-19 pandemic has had an impact to varying degrees on all areas of the business, but what we are trying to achieve has not changed. There will be an unavoidable and unavoidable impact on our business in the short term.

We will work to complete the enrollment of our NHL phase three study.

The patient need more modeling hemolytic anemia is no less real.

No less pricing.

Or no less important today than it was earlier this year.

Raul R. Rodriguez: But fundamentally, we remain on track. This is driven by the resilience and focus of our employees and their commitment to our patients. We will continue to grow Tavalese in the US ITP market, using virtual engagements to communicate across all the vehicles we use.

We will give them a much lower pre need a treatment option.

We will explore how tight at least could potentially provide patience with cobot 19 related pneumonia, a much needed to meet center.

We will continue to advance our one in Iraq, one four programs and put in place a partnership for one or both of these important assets.

We will work harder.

Raul R. Rodriguez: We are excited about the use of tablilis in earlier lines of therapy and the data that we have to support this position. Similarly, we look forward to European patients that suffer from ITP also having access to tablets, and we'll support our excellent partner, Griffiths, in their efforts. We will work to complete the enrollment of our AIHA Phase 3 students. The patient need in warm autoimmune hemolytic anemia is no less real. No less pressing or no less important today than it was earlier this year. We will give them a much-needed treatment option. We will explore how Talvis could potentially provide patients with COVID-19 related pneumonia, a much needed new therapy. We will continue to advance our RIP-1 and IRAP-1-4 programs and put in place a partnership for one or both of these important assets. We will work harder, smarter, and more thoughtfully to accomplish what we set out to do. With that, I'd like to open the call to your questions.

Smarter.

More thoughtful to accomplish what we set out to do.

With that I'd like to open the call up to your questions.

Yes.

Thank you we will now be conducting the question and answer session. If he would like to ask your question. Please press star one on your telephone keypad.

Furniture time would indicate that your line is in a question can you made fresh start to if he would like your move your question from the Q for participant James Speaker equipment, and maybe necessary to pick up your hands that much more pressing the star keys. One moment. Please call me poll for questions.

Thank you My first question comes from the line of you call unless you're moving with Citigroup. Please proceed with your question.

Hi, great. Thank you for taking the question.

First question is related to the prescribing patterns for tablet lease excuse me in light of co that so I understand you shifted to tele health, primarily but what happens for new patients is it possible for hematologists to prescribe tab at least two or a new patient just biotech.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Hello, or do they actually do they actually need to see the patient.

[noise] [noise], Thank you Gulf well hope you're doing well, Alaska Tarek you all to answer that.

Sure and thanks for the question you go and absolutely inappropriate one given these.

These unique time, so so when I was referring to the tele health capabilities that we're seeing out there with our providers and our subsequent then ability to interact with them virtually in fact, a lot of our activities that have taken place in March as well as continued into April as I had articulated our supporting new prescribers. So.

Operator: One moment, please, while we poll for questions. Thank you. Our first question comes from the line of Yigal Nochomovitz with Citigroup. Please proceed with your question. Hi, great, thank you for taking the question. My first question is related to the prescribing patterns for cavities, excuse me, in light of COVID. So I understand you've shifted to telehealth primarily, but what

Not only reinsuring ongoing support of existing prescribers, but to answer your question simply yes are we absolutely have been able to support new hematology. This new chemo clinics with virtual in services Onboarding, even so far is sitting via snail, mail materials or even digitally so that.

Yigal Dov Nochomovitz: What happens with new patients? Is it possible for...

Yigal Dov Nochomovitz: A hematologist prescribes tablilis to a new patient just via telehealth, or do they actually...

They're nurses and their staff are able to educate patients whether they're educating patients in FY 2000 alive in person in the clinic or they themselves are doing either through tele health mediums. So.

Tarek Salam: Thank you, Yigal. I hope you're doing well.

Tarek Salam: Sure, and thanks for the question, Yigal, and an absolutely appropriate one, given these unique times. So, when I was referring to the telehealth capabilities that we're seeing out there with our providers and our subsequent ability to interact with them virtually, in fact, a lot of our activities that took place in March, as well as continuing into April, as I had articulated, are supporting new prescribers. So not only are we ensuring ongoing support of existing prescribers, but to answer your question simply, yes, we've absolutely been able to support new hematologists, new chemo clinics, with virtual in-services, onboarding, even so far as sending materials via snail mail or even digitally so that their nurses and their staff are able to educate patients, whether they're educating patients in situ, you know, live in person in Hopefully, that answers your question.

I'll be honest I've been very impressed by both our internal team as well as our external customers the ability to adapt to to meet the needs of a new patient identification hopefully that answers your question.

Yeah I know that's very you know you think.

Go ahead your lab or else you had a follow up I think as well.

Yeah I was I did thanks, I just wanted to make sure I understand understood Dean's comments, a little better with respect to the the sequential decline for for once you 20 versus Q4, 19, which which I understand it was driven by covered in the latter part of the corridor as well as the typical headwinds but with respect.

To Q 20.

To the extent that you can comment you know or you are you, saying are you preparing the market to expect another sequential decline given given the covert headwinds or or is that reading into it too much.

Deemed go ahead.

Yes, so a couple of things did all that the description of the of the reduction.

The sequential from Q4 to Q2, we had 96 Pablo increasing inventory in Q4.

A five ball decrease in Q1, so 100 wine bottles at a bit more than $9000 per bottle on it on an average net sales price across our business. That's that's almost a million dollars. So as you as you look at the graphic that we showed bid that showed the.

Yigal Dov Nochomovitz: Yeah, no, that's very...

Yigal Dov Nochomovitz: Go ahead. You're alive.

Yigal Dov Nochomovitz: Yeah, yeah, I was. I did. Thanks. I just wanted to make sure I understood the comments a little better.

Operator: Unknown Executive, Yigal Nochomovitz, Raul Rodriguez, Dean Schorno, Richard Miller, Raymond Furey, Unknown Executive, Eun Yang, Nalin Tejavibulya, Rigel Pharmaceuticals Inc.

The reduction in Q1 of 2020 that was that was our purpose purpose there with respect to our view going forward, what what we what we said it at this point is just kind of reiterate what what what Tarek said is that our view is.

Dean L. Schorno: Dean, go ahead.

Dean L. Schorno: Yes, so a couple things, Yigal. The description of the reduction, the sequential from Q4 to Q2, we had a 96-bottle increase in inventory in Q4, and a five-bottle decrease in Q1. So 101 bottles at a bit more than $9,000 per bottle on an average net sales price across our business. That's almost a million dollars.

That yeah, we haven't we haven't given guidance today.

We did see a sequential or we saw an uptick in our business in March that persisted into into April, but we just don't know the the full effect and the access that that will become available to us and we just haven't provided more more information beyond those comments, let me pause there now.

Dean L. Schorno: So as you look at the graphic that we showed, that showed the reduction in Q1 of 2020, that was our purpose there. With respect to our view going forward, what we've said at this point is, and just kind of reiterate what Tariq said, is that our view is that we haven't given guidance to date. We did see a sequential, or we saw an uptick in our business in March that persisted into April, but we just don't know the full effect and the access that will become available to us, and we just haven't provided more information beyond those comments. Let me pause there and ask Tariq or Raul to add more incremental color.

Our target or Robert adding incremental color.

Yeah, Yeah. Thanks, Deane this as Tarek. So you got all the other thing too just to to reinforce is you know.

As Dean articulated what we're not providing guidance in certainly you know like many organizations Ur Cobot 19 is adding an unknown variable.

I I spoke a little bit about the opportunity as well and so well as as an organization that the commercial organization, we would've loved <unk> had our field face to face in front of our customers talking about the second line data, particularly as we had launched it towards the mid mid to late February timeframe.

Tarek Salam: Yeah, yeah. Thanks, Dean. This is Tarek.

Tarek Salam: So, Yigal, the other thing, too, just to reinforce is, as Dean articulated, while we're not providing guidance and, certainly, you know, like many organizations, COVID-19 is adding an unknown variable. I spoke a little bit about the opportunity as well. And so, while as an organization, as a commercial organization, we would have loved to have had our field face-to-face in front of our customers talking about the second-line data, particularly as we had launched it towards the mid-to-late February timeframe, that still represents an opportunity for us. And so, using the vehicles that we have in place, we are consistently delivering that message, whether to new prescribers or existing prescribers as they're thinking about the appropriate patients for Tavilis. So, just consider that as part of the balance of really how we're actually executing out there and delivering messages. Clearly, we can't wait to get in front of them in person when things abate, but we are certainly delivering those messages virtually right now.

That's still represents opportunity for us and so I'm using the vehicles that we haven't place Oh, we are consistently delivered that message whether to new prescribers or existing prescribers as they're thinking about the appropriate patients for Tata lease. So just just consider that as part of the balance of really how we're actually executing out there and delivering message is clearly.

We can't wait to get in front of them in person when things abate, but we are certainly delivering those messages virtually right now.

Okay, Great. That's helpful and this one might be best suited for for Wolfgang with respect to the new initiatives you've announced.

Regarding coven 19 trials in the sick pathway I just want to get a sense was this something that originated from internally within your you know within your among your scientist or were you approached by academic groups that are you know saw the potential for this drug.

To potentially treat treat covert 19 patients just trying to get a sense as to how how it originated and the extent of the investment that you would make in this and this is sort of program.

Yigal Dov Nochomovitz: Okay, great. That's helpful. And this one might be best suited for Wolfgang.

Yeah, So I could answer the latter part of that okay.

Yes. The answer to your question is a is both we have been approached by renowned institutions, who are interested in using this drug at the same time of course eternally and based on the data they're showing you. We have we have thought there might be a up there for this compounds and.

Yigal Dov Nochomovitz: Back to the new initiative you've announced regarding COVID-19 trials in the SICK pathway, I just want to get a sense, was this something that originated internally among your scientists, or were you approached by academic groups that saw the potential for this drug to potentially treat COVID-19 patients? I'm just trying to get a sense as to how it originated and the extent of the investment that you would make in this sort of program.

So this this came at the at the at the right time.

How much money would be spin role do you want to take that [laughter] I do you know you go there a couple of comments, we were interested in acute lung injury, a rds prior to the corporate epidemic me the experiments that though that Wolfgang showed on slide 18, that's published or something we've been.

Wolfgang Dummer: I could answer the latter part of that.

Wolfgang Dummer: Yeah, the answer to your question is both. We have been approached by renowned institutions who are interested in using this drug. At the same time, of course, internally and based on the data that I've shown you, we have thought there might be a market for this compound. And so this came at the right time. How much money would we spend? Raul, do you want to take that?

Very interested in exploring ourselves because they are a rds is though a substantial opportunity a corollary to many other diseases not just scope at 19. So when this came about we knew that this was a good opportunity for us to consider and what we did is if.

Raul R. Rodriguez: I do. You know, a couple of comments.

Raul R. Rodriguez: We were interested in acute lung injury, ARDS, prior to the COVID epidemic. The experiments that Wolfgang showed on slide 18 are published, something we've been very interested in exploring ourselves. Because ARDS is a substantial opportunity correlating to many other diseases, not just COVID-19. So when this came about, we knew that this was a good opportunity for us to consider. And what we did is, Dr. David Santos, Yigal Nochomovitz, Raul Rodriguez, Dean Schorno, Raymond Furey, Dean So how much money it will take, I think I can't say just yet because we don't have that done yet. And So right now, we're exploring this investigator-sponsored trial just because it is the fastest way to begin testing them all.

Having discussions about it and we were subsequently approached US I was not set by institutions that are already working in this area doing trials testing molecules and so this is a an opportunity for us to explore the use of our product in this important new area and obviously, we'll take advantage of it.

So as fast as Glen just put it into human testing.

So how much money it will take I think the I cant takes us yet because we don't have that got done yet and for right. Now we're exploring this investigator sponsor trial, just because there are the fastest way to begin testing the molecule in this setting.

Yigal Dov Nochomovitz: Okay, I got it. Thanks.

Oh, Okay got it thanks, thanks for all that very helpful.

Operator: Thank you, Yigal.

Operator: Thank you. Our next question comes from Chris Raymond with Piper Sandler. Please proceed with your question. Hi, this is Allie Bratzel on for CRISP this afternoon.

Thank you go.

Thank you. Our next question comes from Chris Raymond with Piper Sandler. Please proceed with your question.

Hi, This is allografts on for Chris a this afternoon. Thanks for a for taking my question.

Allison Marie Bratzel: Thanks for taking the question. So I think first, just on the FDA interactions regarding the AIHA trial, could you clarify what the driver was there for increasing the sample size to 90 patients? Was that purely in response to potential COVID-19 interruptions? Or was that upsizing always a possibility as part of a pre-planned interaction with FDA?

So I think first just I'm a that the interactions regarding Ah ha trial could you clarify what what the driver was there for increasing the sample size so 90 patients.

Was that purely in response to potential Coleman 19, interruptions or was that upsizing I'm always a possibility as part of a preplanned a interaction with SDK.

Yeah, I'll, let's go a wolfcamp to answer it then I'll add some color.

Wolfgang Dummer: Yeah, I'll ask Wolfgang to answer it, and I'll add some color.

Wolfgang Dummer: Yeah, sure. So, you know, there was some overlap. We wanted to meet with the FDA, and we arranged for a date and at the same time COVID-19 began. Our original driver was to increase the sample size slightly because it gives us a little bit more incremental power, and actually, to be specific, 90 would allow for one additional placebo responder to get a response, and with a 25% delta, still be statistically significant. So, there was sort of a precaution, and since enrollment went well, we thought this was a very good idea. Now, in the times of COVID-19, it does also mitigate against the potential risk that a handful of patients are not getting enough data to be fully evaluated. Right now, that situation looks pretty good. We are looking very carefully at the amount of missing data and how patients come to the site and get their blood draws, and it actually looks pretty good. The sites are doing a very good job, but this increase in sample size to 90 is a little bit of added risk mitigation against that.

Yeah sure. So you know there was some overlap we wanted to meet with T. F D.

And we we arranged for a deep and at the same time Cobiz 19 or began Oh original driver was to increase the sample size slightly because it keeps it keeps us a little bit more incurring incremental power and actually to be specific 90 would allow for.

One additional placebo response to two to two to get their response and answer that a 25%. They also still hit statistical significance.

So there was that there was sort of a precaution and since enrollment went well. We thought this is a very good idea now in the in the times offer Cobiz 19. It does also mitigate again the the potential risk there, though there's a handful of patient all not getting enough data.

To be fully evaluated right now that situation looks looks pretty good we're looking very carefully into the amount of missing data and how patients come to the sites and get them laterals and it looks actually a pretty good decides to doing a very good job, but this is the increase of sample size. Some 90 is a little bit of Uh huh.

Good risk mitigation that game that [noise].

So the answer is both boto Alley, and I think a you know we were prior to discover thing and rolling eight to nine patients a month in a pretty good clip and we're seeing good trajectory I think we'll get back to that once these sites begin a screen patients again, so it's worth that extra little by this.

Raul R. Rodriguez: So the answer is both, Ali. And I think, you know, prior to this COVID thing, we were enrolling eight to nine patients a month at a pretty good clip, and we're seeing good trajectory. I think we'll get back to that once these sites begin screening patients again. So it's worth that extra little bit of body security for both reasons.

Security for both reasons.

Okay next on maybe affecting pair off I <unk> Oh, no question about four months I'm, probably some following a that's come really doesn't phone calls. Thank you for auto called them out on long haul outperformed on also from HM well HM.

Tarek Salam: Okay, that makes sense. And then maybe we could shift to ICP, a question on the four-month tabloid refill rate. That's climbed really nicely since I think Q4 you first started describing it at around 45%, and now it's up in the mid-50s. I think it was three flat, quote unquote, at around 54%. So could you just talk about kind of the drivers that are impacting that? Was there some Q1 seasonality impact that maybe would have led that to be flat in Q4 and Q1? And then maybe just talk about how we should think about that refill rate growing or maybe beyond the mid-50s or staying steady in the mid-50s.

Hold on corporate office, all performed so well just talk about clinical problem. So I'm talking about Oh, what they're all Oh. He won <unk>, maybe a little about <unk> and coupon Q1, and then maybe talk about how we should think about oh growing or maybe the.

Well the local people still have minimal her Hong Kong.

[noise] part Tarek, you want to take that.

Tarek Salam: Tarek, do you want to take this?

Tarek Salam: Sure. And, Raul, feel free to layer on.

Sure in his role for you feel free to layer on so a great question in regards to our persistency rate.

Tarek Salam: So, great question in regards to our persistency rate. You know, as I shared, we're seeing approximately a persistency rate of four months for the quarter at 54%. And as you articulated, you know, some good progress since launch, actually significant progress since launch. I think as we think about, to your question, about what are the drivers, what are the behaviors, and how do we potentially see that looking forward? Well, certainly, we don't have a crystal ball.

As I shared you know, we're seeing approximately a persistency rate at four months.

For the quarter at 54% and as you articulated you know some good progress since launch I'm actually significant progress since launch I think as we think about two to your question about what are the drivers would have behaviors and how do we have potentially from see that looking forward.

Well certainly we don't have a crystal ball I think what we've articulated in the past is that as clinicians and their staff become more familiar with the products understand about.

Tarek Salam: I think what we've articulated in the past is that as clinicians and their staff become more familiar with the product, understand how to manage the disease with this specific product, understand how to educate their patients about AEs and onboarding of it, as well as, frankly, we talk about the specific patient type that they're using it in. We all believe that all of these factors are going to impact and then correspondingly improve the persistency rate. You know, one of the key drivers, we think, of the persistency rate and its potential growth in the future is really the line of therapy because, obviously, later-line patients have poor prognosis and potentially cycle on and off therapies more frequently. And so, we believe particularly that the second-line data, as we move Tablis into regular usage in the second and third-line setting, that that is going to also correspondingly impact the persistency rate. So, hopefully, that answers your question.

How to manage the disease with this specific product understand how to do a educate their patients about e. cheese and onboarding of it as won't frankly, we talk about the specific patient type that they're using it and we all believes we hope we believe that all these factors are going to impact and then correspondingly improve the persistence.

Right you know one of the key drivers, we think two to the persistency rate.

And its potential growth in the future is really the line of therapy. Because obviously later line patients have poor prognosis and potentially cycle on enough therapies more frequently and so we believe particularly that the second line data and as we move tabutt lease into regular usage in the second and third line setting that that is going to also of course.

Spawning Lee impact the the persistency rate so hopefully that that answers your question.

You know Ellie we just we've just started this in terms of moving into earlier lines of therapy with this new data from the Ash meeting as Tom pointed on in this presentation. So I really are our presence in that segment. Those earlier segment is really very small and that's really provides tremendous opportunity to grow and the opportunity we've been.

Raul R. Rodriguez: You know Ellie, we've just started this in terms of moving into earlier lines of therapy with this new data from the ASH meeting, as Tariq pointed out in this presentation. So really, our presence in that segment, those earlier segments, is really very small, and that provides tremendous opportunity to grow, and the opportunity would manifest itself in more patients, but also more patients staying on the drug longer, higher persistency. And it's not just month four but really across the entire curve that we expect to increase as we get into those earlier lines of patients who have just a better response to products generally and ours specifically with 78%. So I think that's pretty exciting. You should expect to see that continue to increase. You're right; you were 45, now we're at 54, and it should continue to move up.

Interest itself in more patients, but also more patients staying on drug longer higher persistency and it's not just month for but it really across the entire entirely proved that we expect to increase whereas we get into those earlier lines of patients who emphasis of better a better response to products generally in our specifically what 70.

8%, so I think that though that's a pretty excited you should expect to see that continue to increase you're right to you were 45 now with 54 and it should continue to move upward.

Okay got it thanks, so much guys.

Operator: Okay, got it. Thanks so much, guys. Thank you. Our next question comes from Doe Kim with BMO Capital Markets. Please proceed with your question. Hi, good afternoon. Thanks for taking my questions. I was hoping you could talk more specifically about the dynamics of how COVID impacted Tavoli sales in the first quarter.

Thank you.

Thank you. Our next question comes from joking with BMO capital markets. Please proceed with your question.

Hi, good afternoon, thanks for taking my questions.

I was hoping you if you could talk more specifically about the dynamics of how co bid impacted heavily sales in the first quarter.

The other biopharma companies have been reporting that oral therapies have been seeing early refills and an increase in 90 de scripts are causing a temporary performed in sales is that something you also saw or isn't just a difficulty in getting new patients and some slippage in existing patients.

Operator: Other biopharma companies have been

Operator: An increase in 90-day scripts is causing a temporary pull forward.

Operator: Unknown Executive, Eun Yang, Nalin Tejavibulya, Richard Miller, Raymond Furey, Unknown Executive, Eun Yang, Nalin Tejavibulya, Rigel Pharmaceuticals Inc.

Let me take a first step it bad and talking to ask you that comment as well. Thank you Bill I hope you're doing well. So really cute Q1 is typically a challenging quarter was remember last year, we had a quarter that was about flat.

Raul R. Rodriguez: Let me take a first stab at that, and Tariqa, I'll ask you to comment as well. Thank you, Bill. I hope you're doing well.

Raul R. Rodriguez: So really, Q1 is typically a challenging quarter. Last year we had a quarter that was about flat, and this quarter, we were thinking it was going to be about flat, and then in March, we usually see an uptick. We saw an uptick, but it was not as pronounced as maybe we were expecting it to see, and that's what caused this moderation of growth that we came in largely flat, maybe slightly below where we were last quarter, and really, it had an impact in many ways. Doctors and patients are not seeing their doctor on a regular basis, so some of that is insurance resets. Some of that is they just didn't want to go see a doctor under COVID conditions. It's hard to separate the two out, frankly, and say it was due to this and that. Other than in Q1, you see the impact of both those effects, insurance resets as well as COVID keeping patients from moving forward, and so we saw that, and that's what depressed our growth, but as you saw in March, we did see an uptick. It was not as pronounced, and that continued into April. Tarek, any other observations?

And this quarter, we were thinking it was going to be about flat and and then in March usually see an uptick we saw an uptick was not as pronounced as maybe we were expecting it to see and that's what caused this moderation of growth that we came in largely largely flat maybe slightly below where we were last quarter.

And but really it's had impact though in many ways doctors and patients not seeing their doctor on a regular basis. So something about his insurance reset some of that is been doesn't want to go see a doctor in under covert conditions, it's hard to separate the two well frankly I'd say it was due to this and that other than.

In Q1, you see the impact of both those effects insurance resets as well as of the Cogan keeping patients. So from a moving forward and so we saw solve that and that's what depressed R.R.R. grew up that though as you saw in March we did see an uptick is not as pronounced and that continued into April.

I think any any other observations.

Tarek Salam: No, I mean, it's a great question, though, and I think to Raul's point, it's hard to pinpoint the specificity in terms of acceleration due to, you know, long term, long range, like 90 day refills and things like that. We haven't necessarily seen that level of granularity impacting our business. You know, ultimately, with the headwinds we've seen from a reimbursement and insurance perspective, as Raul articulated, we really have seen momentum build in March and April. And obviously, the timing of this and our inability to be, you know, face to face with our customers, is is is is an area that we would have rather been out there in person. And so to articulate whether it's, you know, A or B is a little difficult for us.

I don't know I mean, it's a great question, though and I think to rolls point, it's hard to pinpoint the specificity in terms of acceleration due to you know long term long range like 90 day refills and things like that we haven't necessarily seen that level of granularity impacting our business.

Ultimately you know with with the headwinds we seen you know from a from a reimbursement and insurance perspective as Robert articulated we really have seen momentum built in March and April and obviously the timing of this in our inability to to be face to face with our customers. You know is is.

As an area that we would've rather [laughter], obviously been up been out there in person and so to articulate whether it's a or b is a little difficult for us, but needless to say you know we're really encouraged by just the level of engagement I can tell you. A you know just based on sheer interest alone physicians are amenities.

All to meeting with our both commercial and medical field forces, they're excited to hear about the new data. So so so so just using that as a little bit about litmus test to indicate that the theres a willingness and a need for this information I will say I'm actually pretty encouraged by that.

Tarek Salam: But needless to say, you know, we're really encouraged by just the level of engagement. I can tell you, based on sheer interest alone, physicians are amenable to meeting with our both commercial and medical field forces. They're excited to hear about the new data, so I'm just using that as a little bit of a litmus test to indicate that there's a willingness and a need for this information. I will say I'm actually pretty encouraged by that.

Okay, Great. That's been trial right. So if I could just at a one quick comment there you know what's interesting maybe a little surprising to me.

Is that in in a in the quarter Q1, we saw a decline in inventories that are at our distribution channel or in the distribution channel usually we see a part of decreases as Dean said in Q4, we saw almost 100 bottle increase in inventories and this quarter Q1, we saw a five bothered.

Operator: Okay, great. That's very helpful.

Raul R. Rodriguez: So if I could just add one quick comment there. You know, what's interesting, maybe a little surprising to me, is that in the quarter Q1, we saw a decline in inventories at our distribution channel or in the distribution channel. Usually, we see about an increase, as Dean said, in Q4, we saw almost a 100 bottle increase in inventories. And this quarter, Q1, we saw a five bottle decrease, no increase in inventory, which created that unfavorable comparison. Actually, that was a surprise to me. I would have expected some increase in inventories just because of all that's happening. That didn't occur in Q1.

Decrease no increase in inventory, which created that unfavorable comparison, oh actually that was a surprise to me I would've expected some increase in.

In inventories just because of all that's happening that didn't occur in Q1.

Right right now that makes sense.

And for Gryphons launch in Europe in your communications with them has there been any discussion and a potential delay in that considering how hard Europe has been hit by a pandemic.

Well, what they told us and actually they put out in your press release, a last week is that the product will be available to patients in Europe. This month this quarter Paula and belt. So that's good doctors can actually right. The script and have it filled then in terms of their active promotion of the launch it's a very difficult to.

Raul R. Rodriguez: Right, right. No, that makes sense. And for Griffo's launch in Europe, in your communications with them, has there been any discussion of a potential delay in that, considering how hard Europe has been hit by the pandemic?

Execute on that right now no doubt they'll they'll delay some some about activity.

Raul R. Rodriguez: Well, what they told us, and actually they put out in their press release last week, is that the product will be available to patients in Europe this month, this quarter. And so that's good. Doctors can actually write the script and have it filled.

But the product will be available this quarter, which is good to see and when things clear up a bit bill that they'll move forward no interesting different countries in Europe or are are suffering from this pandemic very differently, Italy, and Spain, maybe a one extreme but it seems that some other countries, Germany is frankly handling.

Raul R. Rodriguez: In terms of their active promotion of the launch, it's just very difficult to execute on that right now. No doubt they'll delay some of that activity. But the product will be available this quarter, which is good to see.

Handling, it's quite well as well as we expected not a lot of disruption of the Scandinavian countries. Norway. For example are doing well and so it's highly buried in Europe itself, not though maybe not too dissimilar to the U.S. in terms of different regions, but in some places I expect them to move forward.

Raul R. Rodriguez: And when things clear up a bit, they'll move forward. You know, interestingly, different countries in Europe are suffering through this pandemic very differently. Italy and Spain may be at one extreme. But it seems that some other countries, Germany in particular, are frankly handling it quite well, as well as we expected, with not a lot of disruption. The Scandinavian countries, Norway, for example, are doing well. And so it's highly buried in Europe. It's probably not too dissimilar to the US in terms of different regions, but in some places, I expect them to move forward more quickly than in other places.

More quickly than in other places.

Okay.

And last question Oh for Wolfgang and the.

Clinical studies for tablets to train three calls that Nova pneumonia and Ards are you thinking about a particular severity of the disease, where it's heavily who will be most effective a and as you have all these other therapies anti virus looking for the more moderate peach. It a will <unk> would you say.

Wolfgang Dummer: Okay. And last question, Apollo 4 Wolfgang, in the... Clinical Studies for Tavolese to Treat COVID Pneumonia and ARDS, are you thinking about a particular severity of the disease where Tavolese will be most effective, and as you have all these other therapies, antivirals, looking for the more moderate patients, would you think that Tavolese would be effective in the most severe patients?

That have leased would be effective in the most severe patients.

Yeah. So if you put to bed yourself have teva leases all the anti viral it's an immune Muslim either right. So I see it the greatest opportunity certainly in in particular initially in the cases that have advanced to pneumonia.

Wolfgang Dummer: Yeah, so if you look at yourself, tablilis is not an antiviral, it's an immune modulator, right? So I see the greatest opportunity, certainly, in particular, initially, in the cases that have advanced to pneumonia. And they could start as early as just, you know, verified pneumonia, but no invasive ventilation required. But I could also see potential in patients who are already on a ventilator. And as you know, they have very high mortality rates. Given what I have shown you and how sick inhibition might work, I think that, definitely, that will be the place to start. Once you get to a point where you have established safety and efficacy at that stage, you could, you know, move yourself forward and say, well, shall we, should we use this as soon as you have any type of respiratory symptoms? But that would probably be the second step.

And that could start is it really is just oh, you know verified pneumonia, but more invasive installation required but I could also see or potentially in the patients who are already on the ventilator and as you know they have like very high mortality rates.

Given how well they have a shown you and how how sick inhibition might broke I think that definitely that would be the place to start its once you get to a point, where you have established safety and efficacy at that stage you could you know move yourself forward than say will show being show we use this as soon as you.

We have any type of a respiratory symptoms, but they would be probably second step.

Got it I hope everyone stay safe there too thanks for taking my questions.

Thank you don't.

Thank you. Our next question comes from the line of Tessa Romero with JP Morgan. Please proceed with your question.

Operator: Got it. I hope everyone stays safe there too. Thanks for taking my question.

Hi, guys I'm, hoping routing wow, thanks for taking the questions.

First one for me on way high as I could.

Operator: Thank you, Joe.

Tessa Romero: Thank you. Our next question comes from the line of Tessa Romero with J.P. Morgan. Please proceed with your question. Hi, guys. Hope you are all doing well. Thanks for taking the questions. First one from me on WIHA, if I could.

So you have widespread sites geographically, which I think could be favorable in rebuilding momentum and when that pool that pandemic I'm running rise edge.

What are the key push pull levers can sit around the enrollment side and potentially sell meeting the prior than men 2021 data timing I think you'll have a 24 week or a six month primary endpoint for this study.

Raul R. Rodriguez: So you have widespread sites geographically, which I think could be favorable in rebuilding momentum when the COVID pandemic normalizes. So, sort of what are the key push-pull levers to consider on the enrollment side and potentially still meeting the prior mid-2021 data timing? I think you have a 24-week or a six-month primary endpoint for this study, and then you have a follow-up.

And then I've a follow up.

Sure well, let's go what's going to add but I will just preface it by saying you know we we think that this is a very attractive opportunity and a the product will be a very important product for patients suffering more modern you'd hemolytic anemia, so our view of the opportunity.

Raul R. Rodriguez: Sure, I'll ask Wolfgang to add more, but I will just preface it by saying that we think that this is a very attractive opportunity and the product will be a very important product for patients suffering from more mild immune hemolytic anemia. So our view of the opportunity really hasn't changed at all. And the reason we believe so strongly in this is that we opened up 80 centers across the world in order to execute on this trial as fast as we can. And that does give us a lot of geographic diversity, which makes the impact of COVID being very different in different European countries. And so it'll help us a good deal, and I think we'll get back to enrolling patients at a clip of eight or nine patients a month once the sites are back focused on this. But that'll be different, and they'll come back at different speeds. And it's hard to predict right now what that speed differential might be, which is why it's harder for us to say when we think it'll be completed. Wolfgang, do you want to add any other thoughts on that?

Really hasn't changed at all and the reason we believe so strongly in this and the is that we opened up 80 centers across the world.

Order to execute on this trial as fast as we can and that does give us a lot of geographic diversity that lays the impact of covert being very different in different European countries, and so it'll it'll help us a good deal and I think we'll get back to enrolling patients at a clip of the eight or nine patients a month once once.

So let's sites are back focused on this but that'll be different they'll come back at different speeds and it's hard to predict right now with that speed differential might be.

Which is why it's hard to for us to say this is when we think it'll be completed what's gonna do you want to add any other thoughts on that.

Yeah, you you Cabot.

Most of the answer for the Christian I guess, we have so so basically what we discussed is you need to be comfortable and your patient needs to be comfortable twist to participate in this study and that means you want to come to your study visit so they can enjoy a bug in the oldest type of things and in the office into high.

Wolfgang Dummer: Yeah, you covered most of the answers for the question. I guess we have so basically, what we discussed is you need to be comfortable, and your patient needs to be comfortable too, to participate in the study. And that means you want to come to your study visit so that we can draw your blood and all this type of thing. And obviously, at the height of the pandemic, their comfort level wasn't very high. I would say now that things are more and more, you know, reopening and beginning to normalize, we can start thinking about this again. But again, things change very quickly these days. But once we feel it is safe for the patient to come back to the site and participate in the study, then reopening enrollment could be considered.

So if the pandemic that comfort level wasn't very it wasn't both very high I would say now that that things are more and more you know reopening in to I'm beginning to normalize.

We can start thinking about this again, but but again its if things change or very quickly. These days, but once we feel you didn't say for the patients to come back at the site and participate in the study then.

Reopening of enrollment could be considered.

Okay.

Okay. That's helpful and that's helpful.

You know I may have missed anything earlier comments, but just a quick ones from me Oh look what sort of in the height of the pandemic, what where are you seeing on annexes vary some t. our action on various is kind of what you're seeing sort of in late March I think you said there was an uptick in April.

Wolfgang Dummer: Okay, that's helpful. That's very helpful.

Raul R. Rodriguez: And, you know, I may have missed it in some earlier comments, but just a quick one for me. During the height of the pandemic, what were you seeing on NRXs versus PRXs versus kind of what you were seeing sort of in late March? I think you said there was an uptick into April. I'm just kind of trying to get at, can you give any more kind of color on if it was new patients that were kind of declining or if it was some of your existing patients? Yeah, any additional color you can provide on that point would be great. Thank you.

I'm just kind of trying to get that can you give anymore kind of color on if it wasn't new patients that were kind of declining or actually it was some of your interest in patients.

Yeah on any additional color you can provide on that point would be helpful. Thank you.

Raul R. Rodriguez: Sure, I'll take a stab at doing that, and Tarek, if you could follow that. You know, we saw continuing activity in both new patients and continuing patients, and you know, pretty good reactions in terms of that. We were very positive at the start of the year in terms of what we were expecting to see, especially given the early line data that we had presented at the ASH meeting, performance in the business across new and established spaces, and then, surprise, this COVID hit during the month where you see an uptick. We saw a bit of an uptick, but not maybe as profound as you would have expected.

Sure I'll take a step up doing that and Tarek. If you could follow them. You know, we we get we we saw continuing activity of boto, new patients in continuing patients and and a pretty good reaction in terms of that we are very positive and started the year in terms of what we are.

Spectrum to see especially given the early line data that we had presented at a at the asked me to and so we were seeing good and that's expected performance in the business across new and established spaces and Bill and ER and then a surprising this covert hit at the month where are you.

See Luxor, we saw a bid up an uptick but not as it has maybe as as profiled as you would have expected.

Hi, Rahul.

Tarek Salam: Yeah, Raul, and Tessa, to your question, I think that last point, Raul, is probably the only point I would have just layered on specifically is that, you know, as you can imagine, Tessa, these are chronic disease patients, and for a lot of oral therapies like TAVILI, not just ourselves, they tend to kind of work their way through these reimbursement hurdles, you know, in the first couple of months. With that dynamic that we've seen, we have seen a more robust uptick in the past to March. So, I think that last point that Raul articulated is just kind of the key point.

Test so to your question I think that last point role is probably the only point I would have just layered on his specifically is that you know as a as you can imagine tests. As these are either you know chronic disease patients and.

For a lot of oral therapies like probably is not just ourselves kind of a they tend to kind of work their way through these reimbursement hurdles you know in the first couple of months and so with that dynamic that we've seen we have seen a more robust up tick in the past a toe to toe in March so I think that last point that <unk>.

It is just kind of the key points.

Okay, Great. That's helpful. On thank you for taking my question.

Tarek Salam: Okay, great. That's helpful. Thank you for taking the time to answer my questions.

Operator: Thanks, Chris.

Thanks, guys.

Operator: Thank you. As a reminder, ladies and gentlemen, if you would like to queue a question at this time, please press star 1 on your telephone keypad. Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald.

Thank you as a reminder, ladies and gentlemen, if you would like tricky. One question at this time. Please press star one on your telephone keypad.

Our next question comes from the line Christian Costco with Cantor Fitzgerald. Please proceed with your question.

Kristen Brianne Kluska: Please proceed with your question. Hi, good afternoon, and I hope everyone on your team remains well. So my first question is, as it relates to the WARM-AIHA trial, I noticed on clinicaltrials.gov that you made some modifications and added new centers during April. Were these centers part of the plan, or have you made any changes as a result of the pandemic? And also, are you looking to potentially explore any backup centers in specific geographies, as you can?

Hi, good afternoon, and hope everyone on your team I mean, well. So my first question is as it relates to the warm and I'd say trial I noticed on clinical trials Dot Gov that you made some modifications and adding new centers. During April where are these centers part of the plan or have you made any changes as it relates to adults.

The pandemic and also are you looking to potentially for any backup centers and specific geography is as you continue to monitor the situation.

Hi, Thanks, Chris and I hope, you're wells as well a little less looking to to answer that.

Wolfgang Dummer: Hey, thanks, Kristen. I hope you're well.

Yeah, no. So we opened a sites according to our plan.

Wolfgang Dummer: Yeah, no, so we opened sites according to our plan, to our originally existing plan that there was no change. To your other point, I think with our 22 different countries, we are geographically pretty well prepared for a reopening. And as I said in my script, this could be a country-by-country approach, right? So if we see that countries like Germany come back to normal a little bit quicker, we can certainly open enrollment there faster than in something very hard-hit like Italy, for example. So I think we are extremely well prepared, as prepared as you can be, for the time of reopening and resumption of randomization.

Two hour originally existing claim that that there wasn't all that there was no change.

To your other point I think with our 22 different countries, we ought to yogurt geographically pretty well prepared and for for a reopening and as I said in my in my script, a this could be a sites by a a country by country approach right. So I agree.

See that countries like Germany or come back to normal or little bit Creek up you can certainly are open enrollment there faster than in some thing very hard hit like like easily for example, so I think we all extremely well prepared as prepared as you can be a for the time or free opening.

And we.

Resumed offer a randomization.

Wolfgang Dummer: Kristen, thank you. Kristen, if I could add on that, you know, April, clinicaltrials.gov had additional sites opening in April. I don't think that's correct.

[noise] crislip it. Thank you, Chris if I could add on that.

From a clinical trial Dot Gov had additional sites opening in April that sneaker I don't think that's correct I think it may have been just a delay in updating the site because I don't think we've added any any sites.

Raul R. Rodriguez: I think it may have been just the delay in updating the site because I don't think we've added any new sites. But one thing that's useful to think about is, you know, as we went forward with this and had the sites open, our thought was having a patient enroll and then not having to make it, or not being able to make any of their visits would not have been a useful advance in the program. We really prefer to have patients where we're confident that they'll be able to make their visits because, otherwise, they're not going to be useful patients to study and enroll.

In April.

But one thing that's that's a useful to think about is the no as we went forward with this and that the sites open our thought was having a patient enrolled and they're not having to make it able to make any of their visits but if not in the useful advancing the program, we really prefer they have to patients where we're confident that.

I'll be able to make their visits because otherwise, they're not going to be useful patients to study enrolled.

Kristen Brianne Kluska: Okay, thank you for that. So while a majority of centers are postponing enrollment, is there anything that your team or investigators can do during this time to try to find patients that could be eligible once things start to open up again?

Okay. Thank you for that so while the majority of centers are postponing enrollment is there anything that you're team or investigators can do during this time to try to find patients that could be eligible once things start to open up again.

Raul R. Rodriguez: Well, you know, the patients are still there, and we know that the patients need a new product such as this. So that hasn't changed.

Well you know the patients are still there and we know that to patients need a meta on new products such as this so that hasn't changed their willingness to come to a clinical trial site on a regular basis story you know stay at home orders is limited because of that and also though some of the centers, especially.

Raul R. Rodriguez: Their willingness to come to a clinical trial site on a regular basis during stay-at-home orders is limited because of that. And also, some of the centers, especially centers that are part of major healthcare facilities in some of these cities, are reluctant to undertake additional obligations like, you know, monitoring patients and so forth when they're focused on other things. So for both of those reasons, it's quite understandable.

These centers that are part of a major health care facilities in some of these cities Oh also reluctant to undertake a additional obligations like you know monitoring patients and so forth when they're focused on other things. So for both of those reasons, it's quite understandable, but as you know the pandemic is not as subs.

Wolfgang Dummer: But as, you know, the pandemic has not had as substantial an impact in some countries, say, Germany, for example, they'll be back to focusing, and patients will be back to visit the clinic looking for potential therapies. And as part of that, we'll consider enrolling them in our trial. But we're following that very carefully. All the centers are places where there are patients. We know they have patients that are potential patients for our clinical trial. Wolfgang, anything further than that?

Actual an impact in some countries say, Germany for example, Oh bill that you'd be back to focusing in patients with back to visit the clinical looking for potential therapies and as part of that will consider enrolling in October but.

But we're following back very carefully all the centers are places where there are patients. We know they have patients that are potential.

Patients for our clinical trial, well, saying anything to anything further than that.

Yeah, maybe just to add.

Wolfgang Dummer: Yeah, maybe just to add, all of these sites have an open eye on who might qualify for that study before they even screen the patient, meaning they have a list of names that they know they have AIHA. Some of them might qualify now; some of them they observe for a while until the hemoglobin goes down. So that list of names exists for most of the sites. And once things normalize and we say, well, let's continue enrolling, you can reach out to these patients, you know, and then put them through real screening and see if they qualify for enrollment and randomization.

It is such that all of these sites haven't opened eye on who buys qualify for that study before they even screen the patient meaning they have at least of names that they know they have a H E. Some of them might qualify now some of them they observe for awhile until the heme Oklahoma.

We have been goes down so date that deadliest names exists for most of the sites and once once things normalize NBC well, let's continue enrolling a you can reach out to these patients are you know and then put them in real screening and see if they qualify for for enrollment and randomization. So so there is X.

Kristen Brianne Kluska: Okay, thank you. And my last question here is, last quarter you listed some potential indications you might look at for fostamatinib beyond chronic IGP and warm AIJ. Have your thoughts changed here at all, or are the same potential list of indications what you're considering at this time? Thank you.

GVT ongoing.

Mm.

Okay. Thank you and my last question here as last quarter you listed some potential indications you might look out for fostamatinib beyond chronic IGPM worn akshay have your thoughts changed here at all or is the same potential was killed indication what you're considering at this time. Thank you.

Raul R. Rodriguez: I think it's a similar list with the addition of ARDS and COVID ARDS specifically or COVID pneumonia more broadly. That obviously was not something that a quarter ago we were thinking about and now it has risen quite quickly, as you have surmised, quite quickly as regards our level of interest, and we're looking at that very carefully.

[laughter] I think it's a similar list with the addition of a Rds and Cobra day, Rds, specifically recovered pneumonia more broadly that obviously was not something at a quarter ago. We were we were thinking about and now is has risen quite quickly as you apps have been surmised in.

In terms of our level of interest and we're looking at that very carefully.

Okay. Thank you.

Kristen Brianne Kluska: Okay, thank you.

Raul R. Rodriguez: Great, Kristen. Thank you.

Breakfast and thank you.

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

Thank you and there are no further questions at this time I would like to turn the slot floor back over to Mr. I will run he goes for any additional closing comments.

Well. Thank you for your interest Beazer times that I think are extraordinary never have we've gone through such of a period of time, though and but I have to say an incredibly impressed and delighted to be part of an organization that worked so diligently to continue their work.

Operator: Well, thank you for your interest. These are times that I think are extraordinary. Never have we gone through such a period of time, but I have to say I'm incredibly impressed and delighted to be part of an organization that works so diligently to continue its work, whether it's at home, whether it's out in the field and on virtual calls. It's been very impressive how quickly and thoughtfully our staff has made that transition. And I think it's a tribute to the dedication to the goals that we have, to provide the product to our patients, to provide them additional product opportunities to treat their illnesses AIHA, COVID, ARDS. We will continue that effort and make sure that we continue to make progress every single week, whether it's in our living rooms, our bedrooms, our homes, or back in the office, I hope soon, or in the labs. So, thank you for your support and I look forward to providing further updates. Take care.

Whether it's at home, whether it's out in the field and and I'm virtual calls.

It's been very impressive how quickly and thoughtfully. Our staff has made that transition and I think a tribute to the dedication to the goals that we have to provide the product to our patients to provide them additional product opportunities to treat their illnesses. They I had shake Kobe Rds.

You bet effort and.

Make sure that though we continue to make progress every single week, whether it's in our living rooms are our bedrooms are homes or back in the office I hope sooner or in the labs. So thank you for your support and look forward to providing further uptakes picture.

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

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

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