Good afternoon, and welcome to Rigel Pharmaceuticals' Financial Conference Call for the Second Quarter of 2018. All participants are in a listen-only mode. We will be facilitating a question-and-answer session at the end of today's conference. [Operator Instructions]. I would like to remind you that this call is being recorded for replay purposes from Rigel's website. [Operator Instructions]. And now, I would turn this conference over to our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel.

Welcome to our financial results and business update conference call. The financial press release for the second quarter of 2018 was issued a short while ago and can be viewed along with the accompanying slides for this presentation in the News & 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, our plans and timings for regulatory and product development and the status and plans of our commercialization of TAVALISSE in the U.S. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent quarterly report on Form 10-Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our CEO, Raul Rodriguez.

Thank you, Dolly. Joining me on the call today in addition to Dolly are Eldon Mayer, our Chief Commercial Officer; Anne-Marie Duliege, our Chief Medical Officer; and Dean Schorno, our new Chief Financial Officer. Welcome Dean. Turning the Slide 6. We have a very important agenda today. I think it's our most exciting ever. We will provide an update on our commercial launch of TAVALISSE and give you some initial insights from the first four weeks of product availability. We will also provide you an update on clinical and regulatory plans for the rest of the year. And finally, we will provide an update on our financial position, including for the first time ever reporting on product revenue. Turning to Slide 8. This is a monumental quarter for Rigel and I'm happy to report here, we are ready to drive to commercial success with TAVALISSE. In Q2 of this year, we achieve the goal that has been in our sights for many years. In April, TAVALISSE was approved for the treatment of adult chronic ITP in patients who have had an insufficient response to a previous treatment. We've been hired, trained and deployed a very experienced commercial team across the U.S. This allowed us to successfully launch TAVALISSE in May, which was followed by our first product revenue which we will report for you today, $1.8 million in net product revenue in just over four weeks. We are already hearing from physicians treating patients suffering from ITP about how the product is improving the lives of some of these patients. And I can't tell you have delighted we are to report to you on our early progress. Before I turn the call over to Eldon to give you a bit - I wanted to give you a bit of a…

Thank you, Raul, and thank you all for joining us today. Before I talk about the launch of TAVALISSE, I like to put this update into contrast. As you know, we launched at the very end of May, so the numbers and trends I'll review here based on only the first four weeks of launch. For relevant, I'll provided additional inside into early trends we're seeing through the first part of Q3. It's important to note that TAVALISSE has been in the market for just two months. So with that said, I'll move on to Slide 13. Since the official launch of TAVALISSE on May 29, initial response indicator strategies are working well. We are receiving positive physician and pair response. I'll delve into these areas a bit more in a moment, but just to summarize, our key takeaways are TAVALISSE's value proposition is resonating well with physicians. Prescriptions are being covered by both commercial and government payers and reimbursement is occurring as expected. We are seeing initial benefits of the TAVALISSE forward indication with demand for the product across all lines of therapy. Slide 14. Early indicators from these first four weeks of launch demonstrate good demand for the product which has continued into Q3, as well as an anticipated channel stocking. In the second quarter, we realized $2.3 million in gross revenue with approximately $700,000 of that in patient demand and the remainder in distribution channel inventory. Importantly, we're seeing a range of doctors across the country prescribe TAVALISSE including, hematologists and oncologist across large practices, small practices and clinics and 77 bottles of TAVALISSE were delivered to patients and reimbursed in the second quarter. We're pleased by this early demand for the product just four weeks in combined with a physician and payer feedback we received to…

Thank you, Eldon. I will start on Slide 21. Now that we have launched TAVALISSE in ITP, we look to leverage the unique mechanism of action of sick and the proven safety profile of the fostamatinib to broaden its use within ITP and beyond into new indications. For ITP, we are on track for an MAA submission this year. We met with the rapporteur and co-rapporteur in the EU. The meetings were constructive and agencies were supportive of our filing strategy. For the autoimmune hemolytic anemia trial, we're having a dialogue with the FDA on the design of a registration study. We expect it to be a placebo controlled trial and we're still discussing with the FDA the details of this program. Finally, we're exploring the use of fostamatinib in order indications. We will provide more details on the fostamatinib product pipeline at the upcoming Investor and Analyst Day. It is important to note that we have composition of matter to 2026 with a five year patent term restoration expected which would provide us with an exclusivity through 2031. Slide 22. Let me update you on our ongoing studies. We continue to follow patients with ITP in a long term extension study. At the most recent assessment, the medium duration of response has not been reached and was greater than 28 months. In autoimmune hemolytic anemia, the primary endpoint was met in stage one with eight patient responding by week 24, that's 47% and an additional responder at week 30. Patients continuing the extension study and there was no new safety signal. Finally, let me tell you a bit about the IRAK program that we moved into a Phase I study during this quarter. The investigational candidate R835 is only available potent and selective inhibitor of IRAK1 and IRAK4 that blocks inflammatory cytokine production in response to toll-like receptor and the interleukin-1 family receptor signaling. Toll-like receptors and interleukin-1 family receptors play a critical role innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions such as psoriasis, rheumatoid arthritis, inflammatory bowel disease and gout among others. R835 prevents cytokine release in response to TLR and IL-1 receptor activation in-vitro. In addition, R835 is active in multiple animal models of inflammatory disease such as psoriasis, arthritis, lupus, multiple sclerosis and gout. The Phase I in healthy volunteer with our IRAK1/4 inhibitor is ongoing. The result from the first cohorts, so linear PK profile and a clean safety profile. Additional single and multiple dose cohorts are planned. Now, I will pass it back to Dean for financial review.

Thank you, Anne-Marie. First, I'd like to say I am extremely excited to be part of the Rigel team at this transformational point in our business. Starting on Slide 25, here are some of the financial highlights from the quarter. First, let me point out that we recognize revenue using the selling methodology when our products are delivered to our specialty distributors. For the second quarter of 2018, 242 bottles were shipped to our specialty distributors, resulting in $2.3 million of gross product sales. 77 of those bottles were shipped to patients and clinics, while 165 of those bottles remain in our distribution channel at the end of the second quarter. We reported net product sales in TAVALISSE of $1.8 million which has been recorded net of estimated discounts, chargebacks, rebates, returns, co-pay assistance and other allowances of $500,000 our gross-to-net adjustments. Progressing to the next Slide, our cost of product sales was approximately $30,000 or about 2% of net product sales. We reported total cost and expenses of $27.9 million in the second quarter of 2018 compared to $19.3 million in the second quarter of 2017. This increased with primarily due to personnel costs for our commercial and medical teams, as well as third party costs related to our commercial launch of TAVALISSE. We expect continued quarter-over-quarter increases in our total costs and expenses. We reported a net loss of $25.6 million or $0.16 per share in the second quarter of 2018 compared to a net loss of $19.1 million or $0.16 per share in the second quarter of 2017. During the second quarter of 2018, we completed a successful underwritten public offering of 18.4 million shares with over $67 million in net proceeds, including the exercise of the Greenshoe in May of 2018. We expected this financing will extend their runway into the fourth quarter of 2019 and provide for our continued commercial costs along with the expansion of certain clinical programs. We ended the second quarter of 2018 with cash and short term investments approximately $135 million. Back to you, Raul.

Thank you, Dean. Before I wrap up, I like to give you an update on our current and future collaboration plans. Our strategy with TAVALISSE outside of North America is to put in place two major collaborations; one, European partnership that would commercialize fostamatinib in all the major European countries; the other, an Asian partnership that would commercialize in Japan and other Asian countries. We expect both of these partnerships to be in place next year starting with the first in the first half of 2019. As an update to our current partnerships, we have been informed by Bristol-Myers Squibb that they will be terminating our pre-clinical collaboration and oncology. The primary reason was difficulty in finding an acceptable dosing regimen and therapeutic window. However, our clinical stage collaboration is continue to make very good progress. BerGenBio is conducting six different clinical trials with our actual inhibitor compound, fostamatinib in various methodologic and solid tumors. Daiichi Sankyo was conducting various clinical trials with DS-30232 and MDM2 inhibitor also in various methodologic cancers and solid tumors. And lastly, Aclaris is conducting clinical trials with a licensed JAK inhibitor in various forms of alopecia areata and autoimmune disease that result in partial or complete loss of hair. Looking at Slide 29, I'd like to remind you; one, we are delivering on our business strategy. We conducted a Phase III program in adult chronic ITP and announced promising results. Our first, we file the U.S. NDA for TAVALISSE and ITP are first. And then we get approval for this indication also our first and we are not commercializing TAVALISSE in the U.S. So let me just summarize for you what we covered on this call. One, there is an important medical need for the treatment in chronic ITP. TAVALISSE is now approved and helps build the significant medical augment need in ITP. Since the launch of TAVALISSE at the end of May, initial response indicates our strategy is working well. We are receiving positive physician, patient and payer responses. Prescriptions are being covered by both commercial and government payers. Physicians are gaining experience with TAVALISSE across all lines of therapy and we believe TAVALISSE shows great potential to change so ITP is treated. And we are now working to expand the potential of TAVALISSE in Europe and Asia via partnerships and we are working to expand fostamatinib and another indication especially autoimmune hemolytic anemia. And finally, we are in a very strong financial position to execute on this strategy. So with that, I'd like to turn the call to your questions. Operator, if you would?

Thank you. [Operator Instructions] And your first question comes from Kyung Yang from Jefferies. Your line is open.

Thank you very much, and thanks for the detailed revenue analysis on TAVALISSE. So obviously it's a very early in the launch cycle, but do you think that overtime, where do you think are you would kind of stabilize in terms of the end user sales compared to cost of product to sales - and then sorry net sales that you are booking?

Okay. Yeah, Dean?

Hi, Kyung. So from a growth to net perspective, we've reported on our growth products sales of $2.3 million or $500,000 of our gross-to-net adjustment or about 22%. Let me - we book that on a selling basis which means that we're required to essentially book revenue on the full 242 bottles that we delivered. So we need to provide estimates of what we think will happen with respect to a variety of factors including the mix, government versus commercial, as well as adjustment such as the Medicare donut hole. So that 22% again is an estimate. We believe that these estimates of all been conservative and therefore we will see, we expect the gross-to-net adjustment overtime to normalize slightly below 20%.

Okay. All right. And then how about in terms of end user demand, so are you shipped 242 bottles, about 77 have a gone to the end users, so that's about less than 40%. So overtime, after a couple of quarters, what do you think would have been a kind of a normalized end user demand when you book your net sales?

Maybe, I just take a small initial step and let a Dean and Eldon join in as well. I think our in-channel demand is - will fluctuate overtime but roughly is at the right number. And we expect to grow that number on the patient driven demand from the 77 week. We showed this quarter to something that is continuing to grow and that's our full expectation.

So, as I noted in my comment and in the details, you see that there's 165 bottles currently in our distribution channel, I'll call it inventory of the distributors. We've recognized revenue on that unit volume. As future quarters roll on, we don't expect to see a material increase to that number at least in the near term. As our business scales, we could see that number increase, but we'll go ahead in future quarters and let you know what that inventory level in the channel is. Again, we think that it will normalize in the area that it is at the end of Q2.

Okay. And the last question is on the collaboration with the Aclaris. So recently they had some data of treatment in alopecia. Can you comment on what your financial agreement in terms of a financial terms with Aclaris in terms of a milestone, potential milestone that you'd receive as well as royalty if the target approved?

So, first a very good collaborator, we have very good progress with the JAK inhibitor that we licensed to them and in June I believe they put out some initial interim data on that molecule. We do get to - we licensed the program to them pre-clinically, so the deal terms are commensurate with that. We do get milestones. And as they make clinical progress and we'll report that as we get it. And we do royalties based on that. The royalties are again commensurate with the preclinical program.

Okay. I mean I think in the past, you mentioned that there a milestone payment at the end of Phase II study?

I think it might be a little beyond that but not very distant in that. So, yes.

Okay. Thank you.

Thank you. And your next question comes from Do Kim, BMO Capital Markets. Your line is open.

Good afternoon, guys and congrats on the launch. On reimbursement, do you have a sense of what the average time to reimbursement approval is and when you said that there's coverage delays, what kind of pushback are you seeing from the insurers for the reason for the delays?

Sure. Hi, this is Eldon. So the first thing is as far as turnaround time which I think is what you're referring to. I think that's an important metric that we will be tracking. And although we're still at the stage of the early launch, it's something that we are analyzing at this time and trying to determine what that means and how that looks. So I don't think at this point that we want to reveal that metric but or talk about that data at this early point. I think it's something we may report on in the future. I will emphasize though that we did have good shipment in the four week time, so I think we are clearly seeing prescriptions move through the system on timely basis. And we're not seeing a majority of patients that are on the free trial program, so that would certainly say don't again there is a limited need for that although we do have patients on that that are beginning to convert over to reimburse. As far as the time with the - I think you're asking, would you mind repeating your second question actually just I make sure I understand it?

Yeah, was the reasons for the coverage delays or potential denials if there or any?

Yeah, I think it's we are working with payers through what's known as an exception process. So as I mentioned, we are gaining access and engaging with the top 25 payers. And so launching in the middle of the year and that will of course take time, usually it's a roughly a six month time period. And so what we're doing is working with those payers and between now and when they have a formal formulary PNT committee to make sure that we have good coverage and that we establish criteria for access. So there is an exception process until we're able to come to an agreement with those payers on like coverage criterion and ultimately being additive formulary and that's again a normal process as expected. And that can take a little bit longer. However, as what many of the larger payers and PBMs, we are working with them as well and we're communicating with them to determine and interim process to move everything along as quickly as possible. So I think any delays that we're seeing are as expected and not anything unusual. We're also engaging with regional payers as well along the way but they're probably know there are many of them and they manage a smaller proportion of lives on a per payer basis.

Great. That's helpful. And for Dean, when you say that gross-to-net will likely go below 20%, what are the primary factors that would drive that changes, is it just all payer mix? And on your prior comments when you said it would be - revenues will stabilize in 2Q or the demand will, do you mean that your transition to a sell-through method in that period?

Yeah. So on the gross-to-net adjustment, so the - as you suggest that the biggest element is the mix. So if our commercial mix and development set, we're estimating about a 50/50 mix between commercial and government payers. On a net basis, the government payers and you think about Medicare and Medicaid program, those are at a lower net price and then the commercial payers obviously the higher price. So that the biggest driver is the mix, as well as element such as that the donut whole will also effects the gross-to-net. So that again is the big driver. With respect to my comment on that normalizing of the in-channel inventory, let me say it again, so in during the quarter, we ended the quarter with about 165 bottles that were remaining in our distribution channel, 77 had been sold to patients and clinic, 165 in inventory. As we go forward, we do expect that that inventory level in the channel would remain at about 165. So as we have volume reporting in future quarters, it will be primarily from new bottles shipped to both patients and clinics and that inventory will become less of a factor in our overall revenue mix.

Got it. Thanks for taking my questions.

Thank you, Do.

Thank you. And your next question comes from Joseph Pantginis with H.C. Wainwright. Please go ahead.

Hey guys, good afternoon. Thanks taking the question. First, I want to clarify something, during your prepared comments you with regard to ongoing marketing you talked about I believe about publishing more data in the coming months, can you elaborate a little bit on that?

Presenting more data on ITP as well as our AIHA, we hope to have some presentations there might be posters at the ASCO meeting for example late this year. And then next year much like we did this year at ER and other conferences.

Okay. That's helpful. Thank you. And then with regard to I guess the initial patient mix you have described on prior calls obviously patients initial targeting is later stage for example you did mention I believe that even some of the responses that physicians are seeing included patients that have not responded well to other therapies, curious to see what level of say earlier stage patients might be in the mix currently?

Sure. I can that one. We are really seeing a very good mix. We expected to see mostly later line patients and we are seeing that overall the majority is probably third, fourth line and later. But we are seeing a significant number of patients at the earlier line of therapy as well. So it's pretty balanced and so we're actually a little surprised by that in a good way. We'd expect to see some sampling of that but it's a little bit better than we anticipated. I think that's a very good sign for the future that already physicians see that this product could have a role in earlier lines of therapy at this point.

So, that is a good sign. Thank you and then my last question, I'm not sure if you can answer yet. You are in ongoing FDA discussions as you mentioned for AIHA, just curious if you could share at least a wish list or sort of your goal of what a pivotal trial might look like even though it's ongoing right?

Let me before I ask Anne-Marie to respond, let me just remind you about the AIHA opportunities, I think - we think it's a tremendous opportunity. I think there's a tremendous medical need in that indication for new treatments specifically one that are embedded approved and verified to be beneficial to patients and that's our objective. And next to commercializing TAVALISSE and ITP and driving that success the second most important thing for this company is moving forward with AIHA and as part of that figuring out what it is if the FDA is going to ask us to do most of which we currently are still in flux. But I'll ask Anne-Marie to address that.

We don't getting into the specifics of the discussion that are ongoing with the FDA. In general, key element of the study design that will matter ultimately which is the patient population the exactly to the patient population to be enrolled the sample size of the trial and the definition of the primary endpoint.

So, those are things that are still in development. And I think we feel comfortable that by the end of the summer and certainly by the time we have our Analyst Day in October that we'll be able to be much more crisp on that and the design of the trial and all the numbers of patients et cetera and some estimate in terms of the timeframes.

That's great. Thanks a lot, guys.

Thank you, Joe.

Thank you. [Operator Instructions] And our next question comes from France Chris Raymond with Piper Jaffray. Your line is open.

Hey, thanks guys and congrats on the progress. You know this might be, I don't think you guys covered this, this might be a dumb question but I thought every patient was going to be given a free bottle like a free one month supply. So can you just clarify this 77 bottles shipped to patients that's reimbursed of paying right, that's not free drug. Is that correct?

That's correct, Chris. So when there is, the way we've structured this program, we looked pretty closely at a lot of guidelines, but the way we structured is if there's a delay in access, the physician or the patient can request an intron supply, so that's the way it's structured. So in our scheme, you know pretty small percentage of patients getting that. So I think that's encouraging, you know that it's not a large percentage but it's also reassuring to our customers, our physicians and patients that you know if they need to get on access quickly - excuse me, get on drug quickly we can provide for that.

That was what I was getting at is, can you give some sort of range as to what that initial number of patients were that required the free drug that might roll over independent patients?

It's less than 15% of what was shipped.

Okay, good. And then the next question. I know you answered a previous question on the lines of therapy, but you had a sense of the source of the 77 patients, maybe a mix between, right you know folks who are on off label right tucks in versus the people in medics, do any sense?

You know that's a great question Chris. I mean that's part of why, I think it's data that we like to analyze a little bit more. We just got the data recently. So I think I'd love to discuss that in the future when we have time to really sift the road and see what it means. I can tell you again it's a mix across you know all patience, all enrollments that we saw. And we have pretty good visibility, just haven't had time to really analyze all the data yet. So it is reliable data. The enrollments that coming to our hub if you will which is Rigel One Care. So as part of the reimbursement process and you probably know how many payers will require a case history to make sure that they have had at least one prior therapy and something they require a standard with a prioritization. So in the course of that process, we do get visibility to a high number of them. We may have more data later. So I hope that answer question for now, we should have more on that at another time.

That's great, thanks.

Thank you. And at this time, showing no further questions in queue. I'd like to turn the call back over to President and CEO, Raul Rodriguez for further remarks.

Thank you and thank you for those questions. So before finish, I'd like to remind you more globally what we're trying to accomplish here. That is provide life improving treatments to patients with serious illnesses and get financially rewarded for this. And I think this quarter for the first time we began to achieve that. Platelet Disorder Support Association meeting, PDSA meeting in Cleveland a few weeks ago, it was their twentieth anniversary and it's my favorite conference to attend on the yearly basis because it's mostly oriented towards patients. PDSA itself is a very valuable ally in communicating the availability of TAVALISSE to patients suffering from ITP. At this meeting, there was real excitement from patients about having a new treatment option. The first new treatment option in over 10 years that's incredible. They were finding out the product and I think a substantial amount of enthusiasm for what they were hearing. At various breakout sessions, they asked, you know has anyone tried TAVALISSE and a number of patients raise their hand on those. I don't know how they're doing, but I think well. What we are hearing from doctors is that they are seeing good initial responses from the patients that they're trying the product and that's very gratifying. So I wanted to thank you for helping us achieve that So in the upcoming weeks, we'll give you regular updates on our progress. We look forward to seeing you at our Analyst Day in October. And thank you so much for your time.

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone have a great day.