Good afternoon, and welcome to Rigel Pharmaceuticals' Financial Conference Call for the Fourth Quarter and Year End of 2017. 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 fourth quarter and year ended 2017 was issued a short while ago and can be viewed in the News & Events section of our Investor Relations page on our website, www.rigel.com. Joining me on the call today from Rigel are: Raul Rodriguez, our CEO; Anne-Marie Duliege, our Chief Medical Officer; Eldon Mayer, our Chief Commercial Officer; and Nelson Cabatuan, our VP of Finance. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook, and our plans and timings for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ than those reported - than those forecasted. A description of these risks can be found in our most recent annual report in Form 10-K and 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. And welcome, everyone. Thank you for your time this afternoon. 2017 was a monumental year for Rigel, and as we worked at potentially new therapeutic options for adult patients with chronic immune thrombocytopenia or ITP. During today's agenda, we will highlight some of that progress and our plans. First, Anne-Marie will provide an update on our regulatory interactions with the FDA regarding our NDA for fostamatinib in adult patients with chronic ITP as well as our plans for European MAA pilot. In addition, she will discuss the clinical data from Stage 1 of our Phase 2 study of autoimmune hemolytic anemia. Secondly, we have made substantial progress in putting in place an excellent commercial team and in developing an understanding of the ITP commercial opportunity. Eldon will provide some insights in his presentation. And lastly, Nelson - welcome, Nelson - will provide a financial update on the last quarter and year end 2017. Slide 8, a number of years ago we made a substantial change to Rigel's strategy; that is to transition from an R&D to a commercial stage company. This strategy was based on fostamatinib as an excellent foundation for this pivot. In 2017, we continued to execute on that strategy. Utilizing fostamatinib as a cornerstone, we completed Phase 3 studies and filed the U.S. NDA for fostamatinib in adult patients with chronic ITP. We continue to manage that NDA towards an approval. We are also planning on commercializing fostamatinib in the U.S. ourselves and working towards that launch. However, ITP is not Rigel's sole focus with fostamatinib. We are also broadening the fostamatinib opportunity with autoimmune hemolytic anemia, which is now enrolling Stage 2 of its Phase 2 study after positive Stage 1 results. Our studies - fostamatinib studies in IgA Nephropathy will have results…

Thank you, Raul. As always, I want to thank my colleagues for their ongoing hard-work and dedication in support of our NDA submission for the ITP indication. We continue to work closely with the agency and remain hopeful that we will be able to bring this investigational product as a new drug to a patient population with unmet medical need. In addition, we continue to accumulate data in patients with autoimmune hemolytic anemia. Finally, we're on track for the results of the IgA Nephropathy study in Q2 2018. Rigel focused on chronic ITP at its first indication for fostamatinib, because there is a significant unmet medical need in this orphan disease. ITP is a rare autoimmune condition with approximately 65,000 adult patients with chronic ITP in the U.S. ITP arises from various disease mechanisms of platelet destruction and in some cases insufficient platelet production. This disease is characterized by an increased risk of bleeding, often with minor forms of bleeding such as bruising [in particular] [ph]. In addition, patients may also have considerable fatigue and a reduction in the quality of life. Bleeding episodes such as GI or brain hemorrhage can be more severe and potentially lethal. The physiopathology of ITP is complex and many factors have contributed to the disease may differ from patient to patient, making this a clinically heterogeneous disease. Treatment options exist, but they are limited, often associated with side effects and the response can wane over time. There is no treatment that specifically prevents platelet destruction. SYK kinase is a key player in the immune system's destruction of platelets in ITP, fostamatinib is a SYK inhibitor with a first-in-class unique mechanism of actions. As a clinical summary of fostamatinib in ITP, the combined Phase 3 studies with fostamatinib demonstrate consistent clinical benefit in treating patients…

Thank you, Anne-Marie. I'd like to review several aspects of our launch preparation and, in particular, some details on how we view the adult chronic ITP market and the opportunity for TAVALISSE, which is the conditionally accepted proprietary name for this investigational product candidate. On a future call, we will discuss topics such as pricing and market access. First, I'd like to review the ITP patient landscape. As part of our market assessment, we conducted quantitative market research and evaluated seven years of ITP patient claims data. And from this analysis, we estimate there are approximately 65,000 adult patients in the U.S. with chronic ITP. This analysis also revealed that in any given year, approximately 50% or 32,500 of those patients are not actively treated for their disease. However, over a longer period of time, we expect to see a proportion of those patients join the treated population. For the other half, the 65,000 patients that are on treatment, we estimate that 15,100 received steroids during a given year. The remaining 17,400 of the treated patients are steroid refractory and received any of the currently available treatment, such as rituximab, TPO agents, splenectomy, et cetera. These patients may need additional treatment options over what is currently available and represent the addressable market for TAVALISSE. Our analysis also looked at treated ITP patients to see how they typically progress through the lines of therapy. This is shown on Slide 27. And as you can see, the ITP treatment continuum is very fragmented, with no single treatment dominating any line of therapy, all therapies are used across all lines. And there are several factors that contribute to this. First, as Anne-Marie mentioned, ITP is a heterogeneous disease, so it's difficult for a clinician to predict which patient might respond to a given…

Thank you, Eldon. We completed two successful financings this year, with over $108 million in net proceeds. This helped us to extend our runway into 2019, including the potential commercial launch cost for fostamatinib. We ended 2017 with cash and short-term investments of approximately $116 million. In 2017, we invested approximately $10 million in launch preparation costs. We expect these costs to significantly increase in 2018, as we continue to invest for potential launch in Q2 2018, including the hiring of a sales force. Implementation of financial systems to support a successful launch, including systems for aggregate spend and transparency reporting are underway. Further, on the Q4 2017 financial results, we reported a net loss of $25.9 million or $0.18 per share in Q4 2017, compared to a net loss of $15.6 million or $0.16 per share in Q4 of 2016. There were no contract revenues from collaborations in the fourth quarter of 2017 compared to $3 million in the fourth quarter of 2016, which was related to the payment received pursuant to a collaboration agreement with Bristol-Myers Squibb. We reported total costs and expenses of $26.2 million in the fourth quarter of 2017 compared to $18.8 million in the fourth quarter of 2016. This was an increase of $7.4 million, primarily due to the launch preparation costs for fostamatinib in chronic ITP as well as cost for managing our NDA submission. Back to you, Raul.

Thank you, Nelson. Let me summarize on Slide 39 for you what we view as the near-term Rigel opportunity. Fostamatinib is a broad opportunity, which provides a foundation for treating a wide range of autoimmune diseases. The orphan autoimmune diseases we have chosen have significant unmet medical need, and fostamatinib SYK inhibition may address the key pathogenesis of these diseases. We have these indications coming in sequence, led by ITP currently at NDA review, followed by Phase 2 with autoimmune hemolytic anemia with strong proof-of-concept data. And then, Phase 2 in IgA nephropathy and more to come. Fostamatinib in these indications provides the ideal product to pivot to a commercial stage company, including limited clinical trial requirements and focus the physician audiences. This allows us to build and leverage a commercial capability broadly. Following along the same path is R835, our IRAK 1/4 inhibitor. This molecule may also address a broad fundamental immune signaling mechanism and allow us to address numerous immune diseases or diseases where the immune system is key. On Slide 32, you see some of the broad range of potential indications for R835. We look forward to introducing R835 into human clinical studies in Q2 of this year. At this time, we'd like to open up the call for your questions.

Thank you. [Operator Instructions] Please stand by for your first question. And the first question is from the line of Kyung Yang of Jefferies. Your line is open.

Thank you. In terms of fostamatinib, the label, do you expect that it's going to be similar to TPO mimetics such as like in insufficient response to steroids, immunoglobulin or splenectomy? Or do you think that it also include - that this will include patients with a prior TPO mimetic therapy?

Yes, at this point, we're making no comment on the label.

Kyung, as you can understand, we're in that constant negotiation discussion with the FDA. It's all regular type of work. And so at this point, we'll defer on that.

So the 17,400 addressable market for the refractory that you mentioned, does that assume that your label would be similar to TPO mimetics?

The analysis that Eldon showed us shows how those lines break up, but we can't at this point discuss what our label is likely to be.

Okay. And then, second question on R835. Is this same as R509 previously?

It's a different molecule at that. And it has a better profile, and which is why we think it's the right molecule to put into MAB [ph]. But it's similar, similar mechanism - identical mechanism.

Okay. So the going to clinic second quarter this year. But in the past, when you talked about R509 you were thinking about the initial indication of gout. Is that still what you are thinking for R835?

At this point, our initial indication or proof for concept on will probably be psoriasis. And we can tell you in a different call why we think that might be a good starting point for the product. But by no means is that the only point of the product. That's the attractiveness about both fostamatinib and R835, that they address fundamental mechanisms. And as a result, we have the opportunity to use them and explore them across a range of immune disorders. And - but we probably will start with psoriasis for some very good reasons, including the rather well-established type of trials that we'd have to do and the well-understood endpoints that we might pursue.

Okay.

Absolutely, and then there is a clear unmet medical need for an oral agent in psoriasis.

Okay. And the last question that I have for you is on warm hemolytic anemia. So, you are enrolling additional 20 patients. Can you give us some update on how many patients have been enrolled? And when you meet with the FDA in the first-half of this year to discuss the regulatory path, do you need all these 20 patients' data to have a conversation? Thank you.

So, thank you. In this we're not making any comments about enrollment in this trial as this is an ongoing process, but we certainly intend to go and talk to the FDA this year. That means that we may not have completed entirely the Stage 2 of the trial.

Okay. Thank you.

It will be - that conversation will be driven by Stage 1, obviously, with all the safety information on the product that we know which is really quite substantial, as you know.

Thank you.

Thank you. Our next question is from the line of Anupam Rama of J.P. Morgan. Your line is open.

Hi, guys. This is Tessa on for Anupam this evening. Thanks for taking our questions. With respect to the updated AIHA data, can you elaborate for us a little bit further on whether there were any corollaries with baseline criteria for the six patients that responded in the first week - first 12 weeks versus the three additional patients that responded in the extension study? And then, I guess, I had a second related one, on any more details you guys were able to provide on the goals of the Stage 2 study and what overall level of durability of response would warrant moving the program forward. Thanks so much.

Right. So, no, we haven't looked yet at the baseline. We know the baseline criteria of these patients. But we have not compared them with the non-responders simply because their numbers are so small and would not give us any meaningful indication. We intend to do that when we combine Stage 1 and Stage 2 studies together. In terms of durability of response, very much like for the ITP program, we're looking forward, and so far that seems to be the case of patient to, in general, maintain the response for as long as they were treated. So certainly a minimum of 12 weeks for the duration of the trial, but also as they continue to the long-term extension study.

Okay. Great. Thank you. Thanks very much, guys.

Thank you. Our next question is from the line of Do Kim of BMO Capital Markets. Your line is open.

Hi, thank you for taking my questions. First, on your filing for TAVALISSE in Europe, if you are planning to file in the fourth quarter of this year, does that mean we should expect the partner to be signed until 2019?

Hi, Do. Thank you for your question. We do expect to have the MAA filing in the second half of this year, Q4 is most likely. We will - we're working with exploring potential partners now. I think, as you can imagine, the approval of the product in the U.S. is an important de-risking step, even though we're talking about ex-U.S. territories, Europe specifically. And so, I think we're really thinking that end of this year, early next year is probably the right time frame for a European partnership. The Asian partnership may take a little bit longer, and that may go into next year. But we don't think that the filing of the MAA will be - any obstacle to that, in fact, just the opposite. I think it makes the opportunity so much more present. That is we should have an approval, if we're lucky, in Europe maybe in 2019. And the partner would take on the regulatory interactions with the European agencies once we sign that partnership and be there once the product is approved.

Great. Thank you. That's helpful. And for AIHA, could you possibly expand on what the regulatory options you would explore with the FDA, and if there is an accelerated path that you could use if TAVALISSE is approved?

Well, we definitely have these discussions internally, both what are the options in terms of accelerated path and also what would be the basis of our discussion. So we're not making any comment at this point, but later on this year once we have clarified and defined and refined these options.

Okay. And my last question is on the financials. Could you give us a sense of where you think SG&A spending would go this year if you get approval?

So, thank you for that question. The financial plan that we have for 2018 included a full investment into commercial launch. And with that we are still in a good position to have a runway that will bring us into Q1 of 2019.

And do you see the fourth quarter spending as a good proxy for your quarterly run rate?

I would think so.

Okay. Great. Thank you for taking my questions.

Thank you, Do.

Thank you. Our next question is from the line of Joe Pantginis of H.C. Wainwright. Your line is open.

Hi, good afternoon. Thanks for taking the question. A quick question on the commercial readiness, I believe you said that you have all of the internal personnel hired. And I just wanted to confirm and see that you're essentially in the press-play mode with regard to the pending approval with regard to hiring the field-force.

Sure, yeah. Most of the internal payment is in place and had been for a while particularly the management team. With respect to the sales force, our national sales director and sales management is in place. And we are now in the process of hiring some of our sales reps, all of our sales reps, some of which are already hired.

Got it. Thank you very much.

Thank you. [Operator Instructions] Our next question is from the line of Elemer Piros of Cantor. Your line is open.

Thank you. Good afternoon. What I'd like to ask maybe, Anne-Marie, if you could help us understand the purpose and what sort of additional information could be obtained from the Stage 2 of the anemia trial.

Simply confirmation of the overall response rate, the Stage 1 was actually very informative, provided exciting results. But this is a small group of patients and we'd like to be able to reproduce this number in Stage 2.

And observing that about one-third of this small trial of the patients responded beyond the initial 12 weeks, would you consider expanding the treatment period? Or do you just leave it as is and then just like in Stage 1, you just follow patients in the extension phase?

No, we're extending the treatment period from 12 weeks to 24 weeks in Stage 2 and then also offering the option of an extension trial.

Thank you very much, Anne-Marie. And just one financial question to Nelson, Nelson, the non-cash items in the fourth quarter also had a significant jump in parallel with the G&A expenses. Would this also be a good proxy for continuing forward in 2018?

Yes, I would think so.

Okay. That was all. Thank you so much.

Thank you. And this does conclude our Q&A session for today. I would like to turn the conference back over to Mr. Raul Rodriguez for the closing remarks.

Thank you for your time today. 2017 was a very exciting year for Rigel. And honestly, we cannot wait for the year ahead. If all goes according to plan and with all the appropriate caveats and knock on wood, in the near future a patient will for the first time receive TAVALISSE fostamatinib and will benefit from it. And their lives will be better for it. And importantly, we will be compensated for this. Thank you all for your support in allowing us to make this happen. We look forward to providing you further updates on regulatory commercial milestones in our pipeline. It will be a great year. Thank you.

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