Q3 2019 Earnings Call

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Oh pharmaceuticals.

Greetings and welcome to your Rigel Pharmaceuticals Financial conference call for the third quarter 2019.

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

Great question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference.

Please press Star Zero honor telephone keypad as a reminder, this conference is being recorded.

It is not my pleasure to introduce our first speaker.

Ali Vance, who is Rigel executive Vice President Corporate Affairs, and General Counsel. Thank you Ms. fats you may begin.

Welcome to our financial results in business update conference call. The financial press release for the third quarter 2019 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.

Weve dealt leave W. Dot right, so dot 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 uncertainties that may cause actual results to differ from those forecasted.

A description of these risks can be found in our most recent route.

Quarterly report on Form 10-Q on file with the FCC.

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 role Rodriguez.

Thank you Deli and thank you for joining us on our third quarter 2019 financial call.

Also joining me today are held in rare, our chief commercial officer, and Dean shorten our Chief Financial Officer.

Today, we're going to review the achievements of our commercial team and recap some of the exciting pipeline opportunities. We discussed at our recent investor call. If you hadn't had a chance to listen to our recent call I would encourage you to do so we discussed some exciting developments in our clinical pipeline, including the introduction of our newest program focused on.

One inhibition, which is now entered a phase one clinical trial.

Also had the pleasure of being joined by Dr. Ivy Ultramar of Duke University, who is our K a well in the hematology oncology space. So do provided some valuable insights on the ITC treatment landscape.

I would like to begin on slide five.

We have four key value drivers, which underlie our business strategy at Roger will take you through each of this today and show you how we're executing across Apollo as this slide shows these value drivers are built upon a strong financial position, which we have further solidified this quarter.

The first value driver is our target lease commercial business in the U.S., which hoping will discuss in greater detail in few moments.

We continue to grow the use us sales of top police in patients with HCP and we have exceeded a 4% market share on an annualized spaces in this billion dollar category.

An excellent achievement in just the fifth quarter on the market and we're excited about the substantial opportunity to grow this year further.

Outside of the U.S., we're continuing our efforts to provide fostamatinib and ITP patients worldwide.

And then put in place a series of partnerships in Europe Asia, and most recently in Canada in Israel again, we're making great progress.

The next opportunity for top Elise isn't warm auto immune hemolytic anemia.

Not only does this have potential to generate substantial revenue.

It is a very synergistic with our current commercial infrastructure.

More importantly.

This is an opportunity to help patients that currently have no FDA approved therapy for a disease that can be extremely debilitated.

We're excited to have begun enrollment in our phase three pivotal trial and are on track to be the first approved therapy in this indication thats exciting.

Finally, the long term value of Rigel comes from our pipeline, which we have continued to progress with our six program as well as our programs with Iraq, one for and Rick one inhibition.

All of these efforts are supported supported by financial stability that comes from several non dilutive sources of capital, including increasing tableau lease sales in the U. us new collaborations milestones from current partnerships and importantly, the recent debt facility, we've put in place earlier this quarter.

On slide six.

I would like to put some perspective around the chronic ITP market and the opportunity for rights will in this indication. This is a very attractive market at $1.8 billion globally and growing.

To this indication, we are bringing our unique and valuable product and today.

And as I said, we are already gaining share in the U.S. In addition in just a few months or we are just a few months away from a potential European approval and market entry in 2020.

Although with the remainder of the global market, including Asia, Canada, and other territories to follow.

Ill now turn the call over to Eldad for a more in depth overview of our commercial operations here in the U.S Ellen.

Thanks for all moving on to slide eight I'm pleased to report that in Q3, we generated 11.7 million in net revenue, which represents approximately 15% growth from the prior quarter.

This growth has been realized by increasing awareness and understanding of the several key product attributes, including number one the mechanism of action for Tabutt lease, which is well differentiated from other ITC therapies number two the total lease efficacy profile, which is appealing to either TP treating physicians and number three.

A safety and Tolerability profile that physicians to you as suitable for long term usage in treating this chronic disease.

Our customer facing teams continue to educate physicians about these benefits as a result, there's a growing body of physicians, who had clinical experience tabutt weights, which we continue to leverage through our peer to peer programs.

We're also pleased continually see improvement in the persistency rate at a four month time period, which importantly surpassed 50% in Q3.

We believe this as a result of several factors, including the continuous movement of takeaways up and the lines of therapy to treat patients with a higher likelihood of staying on therapy as well as supporting optimal dosing and management of adverse events.

Slide nine.

During the recent Rigel Investor call Dr. Ivy Ultimate care from Duke University presented a slide that shows have been various ITC treatments are differentiated.

And explain the top of lease works and a completely different manner than anything else.

Yes unique and important mechanism that addresses the underlying pathophysiology of IP, which we believe the basis for a compelling value proposition to clinicians because a target viki pathway 98, which is immune mediated platelet destruction.

And could cause tallies works differently. It can provide an efficacy profile that is different from other therapies.

Safety profile Taba leases also different for example, unlike rituximab totally to not cause immunosuppression and unlike TP over scepter agonists, probably does not show evidence of increased risk of toward bonuses.

Communicating these important clinical benefits to clinicians has resulted in a growing number of patients that have been treated with top of late.

Such as the following example on slide 10.

Dr. Ultimate are reviewed this patient case study of 61 year old female who is highly refractory to other treatments.

As you can see from the supply this patient received five lines of therapy, consisting of various combinations several different drugs before receiving takeaways.

It's important to point out here that among TP treating clinicians, it's generally accepted but the more refractory patients that less likely they will respond to subsequent treatments.

So the expectations of achieving a durable response for patients such as this or very low.

Slide 11.

Despite this this patient was able to achieve strong platelet response from takeaways and remain on therapy.

As with many new drugs that are launched in a market no new therapies for an extended period of time there are a significant number of patient like this one that do not respond to available therapies.

Placed on top of lease shortly after launch.

We frequently heard many examples of success stories, where patients responded well to probably after failing to several prior therapy.

Entered his experience as such as this that has made a strong oppression.

On physicians in the ITC community.

With these positive experiences many physicians have been using catalysts and earlier line patients for which the market is much larger importantly.

We've been working diligently to generate clinical outcomes data that will demonstrate efficacy of taliesin earlier line treatment.

We can begin sharing that with physicians and increased utilization within the segments of patient.

We're excited that we'll be presenting some of this data in December at the annual Ash conference and plan to publish it next year.

Slide 12.

From the very beginning we've had a sound commercial strategy has real world experience grows we're building support for these efforts, which are focused on number one ensuring that physicians and patient understand the mechanism of action as well as the efficacy and safety profile, especially in large practices, where there's a great opportunity impact a substantial number of patients.

For two supporting optimal dosing and adverse event management.

Or greater chance of patient success, and facilitating long term use three leveraging the increasing number of physicians with experience using probably including key opinion leaders.

For making sure patients have access to top lease without unnecessary reimbursement hurdles.

And five communicating efficacy outcomes with earlier line treatment data to expand utilization of top line and these patient segments.

So with that I'll now turn the call back over to roll.

Thank you Alan preach up.

Now on slide 14, and sell them discuss Tbilisi is being well received by patients and physicians here in the U.S., we believe that globally tableau lease Fostamatinib, we'll have the same impact outside of the U.S.. We are targeting targeting an 800 million dollar market, which currently includes depot agents in production.

Liking the U.S., we have potential to be provide a differentiated product, which for the first time allows doctors to address the under Pat underlying pathophysiology abide GP.

And our recent call we mentioned between goals, we have per ton police fostamatinib in RTP in global markets first is it's to make it available to as many patients as possible around the world.

And second to retain a significant part of products value.

And we're making great progress on both goals.

As you're probably aware in mid October we received a positive trend both from the European CE, HMP, which we believe positions us well for a positive opinion at the CMP meeting in mid November .

This opinion devices, the European Commission on product approval.

And while there is no guarantee that a positive CHS MP opinion will lead to an approval. We do think it's highly likely.

This approval as you May know will add another 20 million in the form of milestone from our partner.

Our partner Cripples plans to make fostamatinib available to ITD be patients in all the major European countries and to launch first in Germany, Germany is the most populous country in Europe with the largest market for it patients.

The great place to start.

Our partnering Japan, Keysafe Pharmaceuticals has initiated a phase of the Japanese clinical trial IDP as it works towards an approval of its end da in Japan.

For the Canadian Israeli market, we recently established the collaborations with a new partner Medicine pharma.

And we have now kickoffs the approval process in Canada, with a new drug submission, which we filed for Fostamatinib in adults chronic ITC.

On slide 15, we overview, the second indication for top and lease which is in warm autoimmune hemolytic anemia.

This is a wide open market potential to be very significant.

Our goal retail leases to be the first approved therapy in this indication.

This is the patient population with no approved FDA approved therapy today tell the leases deferred the advanced and development, providing us with the opportunity to create a market by serving patients with for EMEA trip.

In addition, this indication is incredibly synergistic with our current I keep business.

For the most part ha patients are treated by the same hematologist and he monks that currently care for patients.

If approved we already have established physician relationships in an audience that understands how the leases mechanism of action in how to manage that use will be off and running quickly and efficiently.

For our pivotal trial site in patient enrollment is ramping and we remain on track for topline results in mid 2021.

On slide 16, we have an incredibly productive R&D team here at Rigel, the core of which has been at the company for many years in this discovered all the assets in development that you see here on this slide.

For ourselves we are focused on three development programs are syk inhibitor.

Program led by top Elise Fostamatinib, our Iraq, one for inhibitor program and our Rick One inhibitor program the latest molecule to enter the clinic.

We want to reiterate our pipeline generation strategy, how we approach drug discovery why our approach disadvantaged and how it's six with our downstream development and commercial focus.

First how we do this.

The immune system is an incredibly adaptable and useful system to treat a broad range of diseases, both traditional immune diseases and diseases, where the immune system can be deployed to provide a benefit.

And Rigel, we explored the immune system for targets to play a role in a wide range of disease indications at this slide shows we have been incredibly successful in identifying targets then discovering attractive molecules against these than developing these molecules for ourselves and via partnerships and now come.

Personalizing, our first of these.

We are more than almost any company you sell based assay is to understand the role and benefit of modulating these immune targets.

So based assay is more closely model human diseases, and so provide a more viable small molecule drug candidates.

We do sell based assets you're better than anybody.

For your time consuming their complex, but the yield advantage molecules.

That explains why haven't we have succeeded in finding attractive molecules were others have not such as with our Syk inhibitor Tava lease.

We're also able to use this discovery system to produce multiple drug candidates per program very efficient.

Having these advantage molecules against attractive immune targets allows us tremendous latitude in how we develop them.

Some for ourselves some license to partners and in the future. Some jointly co developed we can address large and small indications a rig a tremendous range of options each tailored to that specific opportunity.

In the next two slides I'd like to reiterate some of the recent advances in our pipeline.

At our Investor call, we discussed the results of the phase one clinical trial of our erect one for program the Tolerability and PK data were very encouraging, but what's what's most important where the results of the Lps Challenge study.

In this portion of the trial, we demonstrated proof of mechanism with almost complete inhibition of inflammatory cytokine production in humans, not just assets in humans with our lead molecule.

The profound inhibition and timing of that inhibition, we are correlated with the circular leading levels of our copper.

We are currently assessing our options to move this program forward and have several avenues to explore.

On slide 18.

We have a brief overview of our recently announced Rick one inhibitor program.

Again, if you hadn't had chance to listen to our Investor call I would encourage you to do so as it will provide greater insights on this program and its importance.

Why you May ask why is Rick one important in ways that exciting.

Rick one is a fundamental immune target and an important mediator of chronic inflammation.

Risk on activation is a key driver of net crop ptosis, a form of self debt in which the cell ruptures and its content spill out into the surrounding tissue, which signal tissue damage and elicit a damaging inflammatory response.

In diseases. This unrelenting redneck fructose is can drive and further destructive inflammation as you may know Rick one can be activated by inflammatory mediators, such as TNF Alpha which itself is a target of many successful pharmaceutical products.

Inhibiting rip one preventing visited met crop to assist in its destructive inflammation opens the door industry many potential indications.

Including diseases of the guts.

The joints the skin.

The brain, including potentially Alzheimer's and they are less and the hematopoietic system, including the bone marrow.

Some of these diseases are not traditionally considered inflammatory diseases borrowing but are increasingly found to have an inflammatory basis.

So Rick one is a very exciting in novel approach to treating these diseases and we have one of the leading programs in this area.

We are pleased to have successfully entered the clinic with this systemic risk one inhibitor molecule and next year plan to identify collected candidate that crosses the blood brain barrier to explore potential CNS indications.

It's great to see our R&D efforts paying off and we will continue to provide updates on these opportunities.

I would now like to turn the call over to Dean for look at the financial Stink. Thank you Raul.

Turning now to slide 20 for the third quarter 2019, we shipped 1355 bottles to our specialty distributors, resulting in $14.4 million of gross product sales.

1291 of those bottles were shipped to patients Aquadex, while 64 bottles remained in our distribution channels at the ended the quarter.

As of September Thirtyth, a total of 500 bottles were made in our distribution channels.

We reported net product sales from top release of $11.7 million, which was 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 18.5% of gross product sales.

This was an increase in net product sales of 15% from the previous quarter and 141% from the third quarter 2018.

Also notable good progress we've made today since launch we've shipped 5430, Tony bottles and generated $44 million net product sales. This reflects the tremendous growth of our business since our commercial launch in may of 2018.

Onto the next slide.

In addition to product sales right. This contract revenues from collaborations was $9.1 million for the three months ended September Thirtyth 2019.

During the quarter, Roger recognized $4 million related to development milestone from acquires therapeutics $3.8 million related to commercial launch milestone payment from impact by our medicines, which was subsequently acquired by Celgene and $1.3 million from our collaboration agreements with triples and Keith.

We are related to performance of certain research and development services.

Moving on the cost and expenses our cost of product sales was approximately $310000 for the third quarter 2019.

Overall cost and expenses were $32.9 million from a third quarter of 2019 compared to $29.2 million in the third quarter 2018.

The increase in cost was primarily due to the ramp up in research and development costs related to our phase three pivotal trial Cavalese impatience reform auto immune hemolytic anemia.

As we've seen in previous years, we expect our cost and expenses to increase in the fourth quarter of 2019, as we continue to execute on our commercial expansion and continue to ramp up our activities in our phase three study in warm autoimmune hemolytic anemia.

During the third quarter, we also announced that we entered into a 60 million dollar term loan credit facility with Midcap financial.

At the closing in September $10 million was funded in an initial tranche. The facility gives us the ability to access at our auction the additional $50 million of which $40 million are subject to the achievement of certain customary conditions.

We ended the quarter with cash and short term investments of approximately $107.5 million.

With this solid cash position and our new inflexible credit facility, coupled with the combination of anticipated continued strong topline growth and Tom waits net revenues anticipated continued generation of collaboration revenues and anticipated growing leverage of our operating expenses.

Rather than a very strong financial position as we look to achieve our financial goals of reaching profitability and creating value for our shareholders.

Before I turn the call back over to roll I'd like to review a couple of future quarter accounting matters.

During October we announced a $5 million collaboration payment related to our newly signed license agreements for Fostamatinib commercialization in Canada in Israel with Medicine pharma.

The agreements with matter sign up provisions in which Rigel has the option to buyback at an amount to be determined in the future alright. The fostamatinib six months after the regulatory approval of Fostamatinib in warm autoimmune hemolytic anemia.

In accordance with GAAP accounting rules, we do not expect to recognize revenue on a $5 million upfront payment and any future payments from Matt assign until such time as our buyback auction lapses.

Also as ROE highlighted in our update on the timing of the CHF <unk> opinion, we would now anticipating in may approval and potential recognition of related revenues do we have described on previous calls to occurred during the first quarter of 2020.

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

Thank you doing before we turn the call over to your question I'd like to retire in reiterate the four key areas that continued to drive value per rigel. The first is our current commercial business in the U.S., which we continue to grow and we will support further with post hoc data analysis, providing insight on earlier.

Use of our product this data will be expected, it's expected to be presented at the upcoming Ash conference, which takes place in early December .

Second outside of the U.S., there was a substantial market opportunity army and we are making fostamatinib available to patients worldwide beginning in Europe next year.

Third we are capitalizing on the potential of top of lease to treat warm autoimmune hemolytic anemia, not only is this the dynamic opportunity for rigel because of the lack of an FDA approved therapies, but there was tremendous synergies with our current RGB business.

And then fourth the cornerstone of our company is the productivity of our R&D team and our pipeline of attractive opportunities that they have produced are sick Rick one in erect one four programs are attractive value drivers rigel in the long term.

And in the short term via our own commercialization and via partnerships.

With that let me turn the call over to your questions operator.

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Our first question comes from Chris Raymond with Piper Jaffray. Please state your question.

Hi, This is Alan Revlon for Chris today, Thanks for taking my question.

So first just wondering if you could talk about any expected seasonality trends for heavily that we should be thinking about as we get into Q4.

On the beginning of July 20, I know the sector can be impacted by seasonal tailwinds at the end of the Erin.

Headwinds at the beginning of the your so any color on what to expect for probably over the coming quarters and also any potential dynamics from mom fluctuations and distributor inventory.

We will be helpful. And then could you also just.

Give us some color on gross to net going forward. Thank you said it was right.

This quarter.

And in line with.

Yeah.

For this year, but just.

The next year.

You talked about 10% price increase in July so how should we think about.

Alright. Thanks.

Sure. Thank you Alley appreciate that help elder now and then Dino I will answer your third question.

There is seasonality in this business as you saw remember Q1, as typically a down quarter beds out of some growth we were delighted with that that we showed.

As insurance resets and Medicaid Medicare.

Donut hole of issues.

Play a role in that.

Second quarter was excellent and Thats, a corollary to the first quarters strong second quarter and you do see seasonality and we expect some seasonality. However, as we said at our last on our Investor call.

We ended Q3 in September with a strong in a strong way very good daily patient demand numbers and we're seeing that continue into the first few weeks of this quarter. So we expect the good strong quarter as well this year.

We are.

No I think you captured all the points there all the second question was on inventory.

I would to say that we would expect to see a mild.

The increase in inventory, that's consistent with the increase in demand as you've seen in the past.

That's all I would add to that you want to comment on that in the GTN.

Yes, just and then Delvon has there been inventory right. There we would expect on inventory that as the as that.

Distribution channel scales and and.

And really get it starts to mature that we could see bid a fluctuation in those inventory levels.

As it compares to the overall clinic and patient demand, we think it'll be a very small element of our of our total volumes.

With respect to the gross to net the 18.5% eight.

Good 0.5, 19% for the remainder of 18 as Im sorry, 19 is what we expect as we move into 20. The price increase is really baked into that 18, 19% that we've seen.

In the back half of this year and therefore, we'd expect to see that carried into.

Ended 2020.

Got it thank you.

Thank you Holly.

Thank you. Our next question comes from Yigal Nochomovitz with Citi. Please state your question.

Hi. This is currently on for your thoughts thanks, very much for taking my question.

We had one on your risk one program just wanted to get your thoughts on how you feel and might be differentiated from competitors and the space, particularly given that recent failure of GSK red wine.

Okay. Thanks.

Thanks, Charlie. Thank you. This is Rick. Thank you for your question on the drip program to really exciting program I'd say the opportunity there is tremendous.

Large indication small indications and we're really delighted to have that that program and as I mentioned one of the leading programs in this area glad to be into clinic.

We havent revealed a lot of information as yet on that program.

Phil in phase one so we're learning more about it our early signs are very positive number were very.

Because the astec about it and and we'll be seeing a little bit more as we get through the phase one clinical prop trial and and talk about the exposure levels and where we see as some of the they really are really useful and attractive features of our lead molecule fivefive too.

That's helpful. Thank you.

Thank you. Our next question comes from Doe, Kim with BMO capital markets. Please your question.

Good afternoon Ah Thanks for taking my question.

Back on your Investor call, a kilo talked about indicators to predict whether a patient would respond to travel lease.

Wanted to see or learn more about your efforts there and how close you are getting how important is finding a biomarker assay to identify responders.

Thank you Joe.

I am not high Joe This is Alan I assume that that question was related to our research on Biomarkers is that correct.

It wasn't just wanted to make sure I understood that yeah. I think there has been work there I don't think that work.

I've heard from the Cantwell community in from scientists to doing research in that area I don't think that that yielded anything that would.

Help clinicians predict who might be a responder.

To our to our product or any other product for that matter.

Anything.

It's a difficult it's a challenge what you would you bring up it's a real challenge for all the molecules in this area and doctors told as frequently.

I wish I knew what would work in the patient that walking in the door and and right now obviously, they reflect simply use steroids and those have a fairly high toxicity, especially at higher doses and after that it really is driven by a variety of factors, but certainly unfortunately for the whole sector. None of those is.

Clear biomarker for Tipo agents reduction or our product in terms of this is the big keep the patient for with which set in Asia will work, it's a challenge and given the heterogeneity obese patients. It's a challenge for them as well I think what we bring is a product that fairly quickly reveals its benefit and thats.

The real usefulness, because you can try the product and frankly, the platelets are in some ways. Its own biomarker you see the platelets go up a relatively quickly and thats a real benefit of our product and I think helpful, especially with relative to a different products a reduction that does take quite some time to show benefit and so while there.

This is such a thing is the definitive biomarker there's work going on this area by the way it yet as yet it really hasn't hasn't yielded what everyone would like but like I said with having a a quick onset of benefit in many cases.

We have out the next best thing and in fact, probably a superior things completely themselves going up I would just add to that it's a great point I would just add to that that of course consistent with.

Any physicians goal of doing harm with the patient when you look at this disease that is benign hematology.

And although it is a serious disease that must be treated when they look at the profile of our product and I. This is what I alluded to earlier and the safety profile that our product offers relative to some of the potential.

Safety concerns with other products I think it adds to the value proposition.

Why not try our product earlier combined with the benefits that we provide what Raul Martin mentioned I think that doctors understand that and lot of benefits that we provide now that they have another option in the markets I realize it wasn't your question, but I would just want to bring that back around in that as a reason that physicians are using our product. Thanks.

That's great and just a follow up on that.

In the upcoming Ash presentation.

On the less refractory patients from the phase three studies do you anticipate a commercial impact from that data or how can you leverage those results in your marketing efforts.

Sure well, we do plan on communicating.

That.

Those outcomes, we believe that they are consistent with the label.

They are coming out of our phase three study and at the same product and dosage and everything else. So we think we'll be able to communicate that Additionally, as I mentioned, we're planning to publish on that I don't have a specific timeline, but.

Perhaps in the first half of next year will say so those are some ways. In addition to all the other channels with through which we communicate with physician peer to peer speaker programs educational programs, especially once it gets into the domain but.

We have known and doctors understand that the patient population that was.

Treated and our pivotal studies was a relatively advanced refractory more severe longstanding disease patient population. So when they see our efficacy bake they understand that and so it's long been suspected from physician visits feedback that we heard in our advisory boards another channel that.

Earlier line patients would probably see a better response rate so.

I think it's an expectation that is consistent excuse me outcome, that's consistent with the expectation for our products I don't think feeney surprise, but I think it will be very meaningful to physicians that like our product profile and are looking for validation that they.

Have a good clinical reason to do that so we will be communicating that through a number of ways I wish I could tell you more at this point, but you know that data is course embargo.

But we're we're excited about it anything else went out there yeah. You know it's it's eight when you bring up a very good point at the earlier lines of our legal allows us to treat a wide range of patients and we'd like to have our product available and be part of the decision and every one of those entry points immediately after steroids after.

To that after that and after that and these patients as you may know do substantial amount of cycling in and out of products. They try a product for a few months and then they don't something doesn't happen then they try something different allows us tremendous number of entry points and we'd like to be part of that decision and this data in earlier patients.

Solidifies, our ability to make that argument well and.

At the up from our own clinical trials will be presenting some data you'll see that shortly and then other sources of data, including real world data and maybe other studies that we will work on we'll provide that that basis. So it continues to be a focus of ours, because I think that's an important I'm an important objective for the company to get patients.

Our dreams of patients to to try our products I think many of them will succeed.

Great. Thanks for taking my questions. Congrats on the progress. Thank you don't.

Our next question comes from Tessa Romero with JP Morgan. Please state your question.

Hi.

Thank you for any updates here I'm, sorry, peaking question Oh.

I did pretty well from you guys will happen. Please go ahead John .

From a lot here in December Jeff.

No.

Our job to relieve that I suppose on crop for tomorrow, we might expect to see I'm seeing that well now I will walk away until the fall presentation at the conference.

And then my second question I don't know about this before but I wondering if you all might be able to update us on how many patients have been treated with Apollo here today.

So how repeat prescribing tracking on the quarter. Thanks, so much guys.

Thank you Thats I appreciate that.

Yeah, I think you're absolutely right the ash abstracts come out tomorrow.

And so definitely keep an eye after that I think it will be very excited I can't tell you within them, though because that's that's well get our hands left so I'm just way today, I think you'll see that but definitely look out for those element on the second question sure.

Yes, although we havent been revealing specific numbers of patients treated yeah. I can tell you that we're very pleased with the traction there, we're seeing and seeing a consistent.

It's still maturing and those than the numbers of patients but.

And with we're excuse me, we're pleased with the growth we're seeing across all of those.

Okay, great. Thank you so much for taking my question. Thank you Tessa.

Thank you just a reminder to ask a question at this time press star one on your telephone keypad.

Once again to ask a question press star one on your telephone keypad.

Our next question comes from Kristen Kosco with Cantor Fitzgerald. Please state your question.

Hi, good afternoon. Thanks for taking my questions [laughter] touching on the patient example, you provided on slide 11, I wanted to hear what position thoughts you here are going into place when deciding when appropriate during the treatment paradigm went to either increase or decrease the dose of travel east.

[noise] sure well.

We recommend a that ER physicians give a patient or at least a three month trial before discontinuing treatment and treatment. In this disease is very much individual lives. So are often physicians, although in our clinical studies roughly 85% of patient Didnt escalate to the 150.

Milligram VIP dosage of physicians will handle that on a case by case basis. So we do.

Recommend a dose escalation along the way if they're tolerating it but many physicians do choose to maintain patients at the 100 milligram dose if they're seeing a response at clinical responses adequate first our monitoring not just platelet counts, but the clinical response.

Launch to date, we're seeing still the majority of patients being maintained on the 100 milligram dose.

So we'll continue to monitor that does seem to be moving up gradually.

But yeah we.

Yeah, we don't we probably would not see that reached the point that of 85% in the clinical studies, but we'll see on we'll see what happens overtime.

Yeah, you know just a final point on that patient really remarkable failed everything else very difficult patient to treat and now they have a treatment that allows them to be maintained well with the AG is well managed as well at 100, which just it's just tremendous so success for that patient I'm getting to 200000 platelets just off.

I mean, I think it's something that you see something like that and then that Dr. tries to the product in the second and third and fourth patient and in fact earlier patients as well and and that's a very good objective and we're delighted with that.

Great. Thanks, and then outside of reporting platelet counts and safety profile can you talk about some of the quality of life measures that you're hearing from physicians on the station.

Yeah, I mean anecdotally a we here I mean first of all as I mentioned before platelets other primary measure, which is tracked and reported and offer this becomes the the language that it used to discuss and describe the efficacy of these products, but it's.

Speaking to physicians more and more of course, what they are really interested in is a clinical benefit.

Which includes its primarily focused on reduce bleeding events, which of course has a major impact on their quality of life group, saying, just leading in everyday lifestyle, whether the brushing their teeth or you know they are they.

It limits the amount of activities that they can have because if you're getting a brews or scratch or anything else that could cause any kind of leading which is not a problem for most normal folks, but the other point is about and we're seeing that im hearing that as he has he would asked we also see this is outcomes from our studies, but additionally, awesome.

Use of rescue minutes, which require patient to go back end to see their doctor and perhaps getting into fusion or injection or a which can not only.

We have an impact and quality of life from that procedure, but also from these side effects of the drug. We also hear anecdotally of course about the reduction into key which seems to be well correlated with this disease. Although you don't hear as much about that it's certainly something that patients here about.

And although we don't have any specific outcomes on that yet.

Thing that will look to study in the future.

Does that answer your question.

Yes. Thank you.

Great Christian Thank you.

Thank you there no further questions at this time.

Like to turn the floor back over tumor soon Rodriguez for closing remarks. Thank you.

Thank you everyone and thank you for your interest in Rigel, you know, it's been a as the last call for the year. So.

It's been a great year across all of these areas of Rigel in terms of off a commercial launch of the product and then execution.

It's great to see see tremendous acceptance of the product and acceptance broadly and tremendous progress on that front to progress in outside the deals outside the U.S. and putting a collaborations in place we put three of them into last 12 months with very good parties across the major territories over the world and have made great pro.

Progress in making the product a approval to happen and shortly will hopefully see one the first one of those in Europe . The second largest market in the world for IC P. treatment. So that's that's fantastic launching and now enrolling our ha trial, a tremendous opportunity highly synergistic again, a tremendous advantage.

There as well and then the pipeline I invest pipeline is something until recently, we really haven't discussed very much and we're delighted with the progress made there with both our Iraq and our reported programs very good progress exciting opportunities tremendously large opportunities and are across the board I think all of those have just.

I believe well in the last 12 months again the foundation a solid a solid financial foundation for the company as well and I think there we've made tremendous progress as well. So we exit the year I think on an incredibly short footing with tremendous potential. Thank you for your support.

Thank you.

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

Q3 2019 Earnings Call

Demo

Rigel Pharmaceuticals

Earnings

Q3 2019 Earnings Call

RIGL

Tuesday, November 5th, 2019 at 9:30 PM

Transcript

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