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Edited Transcript of RIGL earnings conference call or presentation 2-May-17 9:00pm GMT

Thomson Reuters StreetEvents

Q1 2017 Rigel Pharmaceuticals Inc Earnings Call

South San Francisco May 10, 2017 (Thomson StreetEvents) -- Edited Transcript of Rigel Pharmaceuticals Inc earnings conference call or presentation Tuesday, May 2, 2017 at 9:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Anne-Marie S. Duliege

Rigel Pharmaceuticals, Inc. - Chief Medical Officer and EVP

* Dolly A. Vance

Rigel Pharmaceuticals, Inc. - EVP of Corporate Affairs, General Counsel and Corporate Secretary

* Raul R. Rodriguez

Rigel Pharmaceuticals, Inc. - CEO, President and Director

* Ryan D. Maynard

Rigel Pharmaceuticals, Inc. - CFO and EVP

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Conference Call Participants

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* Anupam Rama

JP Morgan Chase & Co, Research Division - VP and Analyst

* Do Kim

BMO Capital Markets Equity Research - Analyst

* Eun Yang

Jefferies LLC, Research Division - MD and Senior Equity Research Analyst

* Maneka Mirchandaney

Piper Jaffray Companies, Research Division - Research Analyst

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Presentation

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Operator [1]

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Good afternoon, and welcome to Rigel Pharmaceuticals Financial Conference Call for the First Quarter of 2017. (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 will turn this conference over to our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel.

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Dolly A. Vance, Rigel Pharmaceuticals, Inc. - EVP of Corporate Affairs, General Counsel and Corporate Secretary [2]

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Hello, and welcome to our financial results and business update conference call. The financial press release for the first quarter of 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; Ryan Maynard, our CFO; and Anne-Marie Duliege, our Chief Medical Officer.

As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent quarterly report in 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.

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [3]

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Thanks, Dolly, and welcome, everyone. Thank you for your time this afternoon. As you know, this year, we achieved significant clinical and business milestones in support of our transition for Rigel into a commercial-stage biotechnology company. This work aimed to provide new therapeutics to patients with chronic immune thrombocytopenia, or ITP, as well as for other indications. We are very pleased with our momentum, and we will take this opportunity to recap our efforts over the last few months and what we expect to achieve in the balance of 2017 and beyond.

In mid-April, we submitted a New Drug Application to the U.S. FDA for fostamatinib for patients with chronic and persistent ITP. We expect to receive notification regarding their decision on acceptance of the NDA in June. Last week, we announced that the U.S. FDA has conditionally accepted the proprietary name Tavalisse for our lead investigational drug candidate, fostamatinib disodium, Tavalisse.

Data from our FIT Phase III clinical program were consistent across our 2 pivotal studies, 047 and 048, as well as the long-term, open-label extension study 049. Patients who responded to Tavalisse had a timely, robust and a sustained response to treatment. These 3 themes, timely, robust and sustained, underscore the potential value of Tavalisse, which Tavalisse may offer patients. The rapid response gives an early feedback as to whether Tavalisse may be a viable treatment option for patients with ITP. The robust response becomes clear when you see that in the pivotal studies 047 and 048, patients' platelet counts rose and then held steady at about 100,000 platelets per microliter of blood.

Our analysis also demonstrates that Tavalisse may provide an enduring benefit based on the median data of 16 months treatment from studies 047 and 048 and increasing, which gives patients and their doctors confidence that the disease is controlled in the long term. As expected, the FIT Phase III clinical program confirmed that Tavalisse has a consistent and predictable safety profile, the profile aligned with the safety database of over 5,000 patient years, which we have accrued.

Later, Anne-Marie will provide an additional background on the NDA submission and regulatory milestones as well as additional details regarding fostamatinib for the treatment of other disorders. But first, I'd like to briefly review a few additional first quarter activities.

In January of '17, we reported results from the first cohort of the Phase II clinical study of fostamatinib in IgA nephropathy. The study found that at 24 weeks fostamatinib at 100 milligrams BID was well tolerated. The data also suggested that a trend exists towards a greater reduction in proteinuria in fostamatinib-treated patients relative to placebo. We expect that today's second cohort evaluating a higher dose of fostamatinib at 150-milligram BID will finish enrollment in 2017 with results in 2018.

In addition, enrollment remains on track for Stage 1 of our Phase II open-label study of fostamatinib for the treatment of warm autoimmune hemolytic anemia, also known as AIHA. We expect to have results from Stage 1 of the trial in 2017.

And finally, in February of 2017, we completed an underwritten public offering of 23 million shares of common stock, which resulted in net proceeds to Rigel of about $43 million. Well, as you can see, the first quarter has been a very productive one for Rigel, I think a monumental one in the history of the company.

I will now turn the call over to Anne-Marie for her presentation. Afterwards, Ryan will report our first quarter financials. Anne-Marie?

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Anne-Marie S. Duliege, Rigel Pharmaceuticals, Inc. - Chief Medical Officer and EVP [4]

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Thank you, Raul. First, I want to congratulate and thank all of my colleagues for their hard work to assemble an extremely comprehensive NDA in support of fostamatinib for patients with chronic ITP.

Looking at Slide 10. We'll provide an overview of what this NDA submission is, including results from the FIT Phase III program for fostamatinib in chronic ITP. This NDA was comprised of 47 clinical trials, 163 patients with ITP, over 4,600 patients total and approximately 5,200 patient years of data. The NDA included, of course, sections on preclinical studies and manufacturing. As an aside, if we were to actually print out the NDA submission, it would total approximately 1.6 million pages that would stack over 500 feet high.

Very briefly, as shown on Slides 11 and 12, Rigel focused on fostamatinib for chronic ITP because there is a significant unmet medical need. There are approximately 60,000 to 125,000 patients with chronic ITP in the U.S., and it qualifies as an orphan disease. The chronic ITP patient population is very heterogeneous, meaning that this is challenging to predict which patient will respond to which of the currently available treatment, if any.

SYK kinase is the key player in the immune system destruction of platelets in ITP. Fostamatinib is a SYK inhibitor, and therefore, has a unique mechanism of action in the context of ITP. ITP patients can have platelet counts that fall 30,000, a level at which they're generally considered at risk for continuous or trauma-induced hemorrhage. Through our clinical program, we demonstrated that fostamatinib may help certain ITP patients and that the benefit was consistent across all subgroups analyzed, including TPO experienced patients who have had limited treatment options remaining.

A quick review of the Phase III clinical program on Slide 13 shows that the 2 identical placebo-controlled studies, 047 and 048, that included a total of 150 adult patients with chronic or persistent ITP. Patients were randomized in a 2:1 ratio into fostamatinib or placebo group and then dosed for up to 24 weeks. The primary endpoint was the achievement of a stable platelet count equal to a greater than 50,000 per microliter on at least 4 of the last 6 clinic visits from weeks 14 to 24.

At the conclusion of the participation in either of the 2 studies, patients were invited to enroll in an open-label, long-term extension study 049, where all patients received fostamatinib. Results from the 047 and 048 studies shown on Slide 14 show a consistent, stable platelet response of 18% in the fostamatinib groups. Review of the data provided additional insights. When patients respond to fostamatinib, they respond quickly with a robust and sustained response.

Looking at the chart on Slide 15. You can see how quickly the median platelet numbers for fostamatinib responders began to occur. That's the green line. The platelet counts continue to rise to approximately 100,000 per microliter, where they held steady.

In a post-hoc analysis, when adding the stable and intermediate response rates, the overall response rate for studies 047 and 048 shown on Slide 16 is 29%, which is 29 out of 101 for the fostamatinib group compared to 2% from placebo. And the difference is highly significant at less than 0.0001. The important point is that the primary endpoint is the stable response, and this is the basis for our discussions with the FDA. The intermediate response is the post-hoc analysis that supports a clear treatment effect of fostamatinib.

Lastly, the last table on Slide 17 show adverse events in the fostamatinib group in studies 047 and 048. And they were generally mild to moderate with GI, with gastrointestinal, blood pressure and LSD adverse events reported most frequently. All adverse events were manageable and reversible.

With the NDA submitted to the FDA, the expected regulatory milestones are FDA's acceptance of the NDA submission, likely an ODAC panel, FDA's decision on approval being anticipated in 2018. Also, by the way, we're recently accepted for an oral presentation at the EHA conference in Madrid in June of our 2 pivotal Phase III trials, 047 and 048. Now I want to spend a bit of time providing an overview of our additional clinical results -- studies on fostamatinib in other indications.

Moving to Slide 18. Raul mentioned our study of fostamatinib in IgA nephropathy, the most common glomerulonephritis worldwide. The disease causes inflammation and scarring of the kidney. People with this rare condition are at risk of serious complications from kidney dysfunction, including high blood pressure and renal failure.

The first cohort in the Phase II study, outlined on Slide 19, was completed at various centers throughout Asia, the U.S. and Europe. The cohort evaluated the efficacy, safety and tolerability of low dose of fostamatinib as measured by change in proteinuria, renal function and histology. The primary efficacy endpoint was the mean change of proteinuria from baseline at week 24, shown on Slide 20. The study saw that at 24 weeks, fostamatinib was well tolerated with no new safety signal detected. As Raul mentioned, the initial data suggest a trend towards a greater reduction in proteinuria in fostamatinib-treated patients relative to placebo. We expect that the second cohort will finish enrollment in 2017 with results in 2018.

Briefly, I also want to comment on fostamatinib in autoimmune hemolytic anemia, or AIHA. Affecting approximately 40,000 adult patients, AIHA is a rare serious blood disorder where the immune system produces antibodies that result in the destruction of the body's own red blood cells. Enrollment remains on track for Stage 1 of our Phase II open-label study of fostamatinib for this indication.

And seen on Slide 22, Stage 1 of the Phase II study will evaluate the safety and efficacy of fostamatinib in approximately 17 patients with autoimmune hemolytic anemia who have previously received treatment for the disorder but have not benefited from this treatment. We plan to have results from Stage 1 of the trial in 2017.

Now I will turn the stage over to Ryan to provide the financial update. Ryan?

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Ryan D. Maynard, Rigel Pharmaceuticals, Inc. - CFO and EVP [5]

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Thanks, Anne-Marie. For the first quarter of 2017, we reported a net loss of $15.3 million or $0.13 per share compared to a net loss of $17.5 million or $0.19 per share in the first quarter of 2016.

Contract revenues from collaborations of $3.6 million in the first quarter of 2017 was comprised primarily of the $3.3 million payment from BerGenBio that we received as they advanced BGB324, the small molecule AXL inhibitor, into Phase II. Contract revenues from collaborations of $5 million during the first quarter of 2016 were primarily comprised of the $4.8 million amortization of the $30 million upfront from BMS related to potential immuno-oncology therapeutics.

We reported total costs and expenses of $19.8 million in the first quarter of 2017 compared to $22.6 million in the first quarter of 2016. The decrease in costs and expenses was primarily due to the decrease in personnel and research-related costs that resulted from the reduction in workforce that happened in September of 2016. This was offset by increases in costs related to the NDA preparation as well as preparation for the potential commercial launch of Tavalisse in ITP.

As Raul mentioned, in the first quarter of 2017, we completed a successful follow-on offering where we brought in over $43 million in net proceeds.

As of March 31, 2017, we had cash, cash equivalents and short-term investments of $98.1 million compared to $74.8 million as of December 31, 2016. We expect that this amount will be sufficient to support our current and projected funding requirements, including the aforementioned preparation of the potential commercial launch of Tavalisse in ITP through at least the next 12 months. However, we are actively evaluating ex-U. S.A. partnerships for Tavalisse as well as other partnering opportunities across our pipeline.

Back to you, Raul.

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [6]

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Thank you, Ryan. So before turning the call over to your questions, I'd like to take a step back and make a few comments, if I may. So this quarter really has been an exceptional one for Rigel. And the team here, as Anne-Marie said, has really done an extraordinary amount of effort to submit our NDA to the FDA, and at the same time, preparing for our first commercial launch in the U.S. And it really does take a whole company and it takes a whole lot of company working for a long, long time and many weekends to achieve that success. So I'd like to thank every one of those individuals who worked so hard to getting us to file the NDA and for the people preceded them that worked so hard on this product to getting it to the stage where we can contemplate the NDA. So thank you, all of those people.

Reflecting on what we've accomplished in the last 12 to 15 months, I'd like to just take you through some of that just to remind you. One, we showed that Tavalisse may be a viable treatment option for some ITP patients. That was an important accomplishment. We put together the NDA, and we are moving ahead with it through regulatory milestones to get the product to the ITP patient community. We've also met in the last 12 months with ITP patients, ITP patient advocates and doctors who told us about the disease and the burden the disease places on their lives and the need for new treatment options.

And here, I think it's very inspirational for us. When we see our drug in the hands of the patients, albeit in the context of a clinical trial for now, that we're seeing that drug help that patient and make their lives appreciably better. That really is inspirational to me and I think for everyone else in this company. And effectively, it's why we are here as a company, to get a drug to a patient who makes their lives substantially better by benefiting that drug. So it's really an inspiration to move ahead, and it causes us to work all the harder to move the program forward.

In addition, our partnered programs have also made some very substantial progress in the last 12 months. Some of our partners have started now Phase II trials, and some partners have started clinical trials, and others are preparing to -- the work necessary to file an IND, all with molecules discovered here at Rigel. So we're very pleased with that and look forward to them making progress against some serious diseases.

And then finally, the fundraising this year and the restructuring, as difficult as it was, provided the resources that have allowed us to invest in regulatory and commercial readiness for this product. The progress is always slower than you would like. It always precedes in fits and starts, and it's always more work than you expected it to be. But the progress really is on the macro level, steady and it's forward. And that's what we're happy with.

So we're very pleased with what we've been able to do in the last 12 to 15 months. All of this positioned us very well for moving forward. First, managing the NDA towards a potential approval for Tavalisse for chronic ITP, preparing for potential commercial launch in the U.S. in 2018 and then the continued expansion of our pipeline.

So with that, what I'd like to do is open the call up to your questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And your first question comes from the line of Eun Yang of Jefferies.

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Eun Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [2]

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A couple of them on the fostamatinib. When you submitted an NDA, did you apply for Priority Review?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [3]

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Eun, thanks for the question. So we had a decision on that. We did not. And the reason is that we felt that such a thing would narrow the label of the product. And we thought we very much would like a very broad label for this product. And while we thought that was obviously something that was a judgment call, we prefer having a broader label than a narrower label. And the filing for such a review would necessitate us asking for a narrower one than we wanted. So we decided against it.

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Eun Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [4]

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Does the narrow label mean refractory patients?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [5]

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Yes.

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Eun Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [6]

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Look at after TPO mimetic use?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [7]

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Correct, yes. And we did the trial, as you probably know, in all patients after one prior drug had failed. It's almost always a steroid. And including TPO-naive patients and TPO-refractory patients. And the product works across all of those subgroups. And so we would prefer having a label that's broader that includes all those subgroups. And instead of arguing for a narrower label with a slightly faster review, we thought that, that was just not a smart strategy for us with this product.

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Eun Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [8]

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Do you still expect an FDA panel in the fourth quarter of this year?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [9]

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We do. It's going to be the fourth quarter. It also could be January though. It's not really that certain what the exact month will be. But it will be towards the end of this year or maybe very early next year.

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Eun Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [10]

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Okay. And then...

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [11]

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We don't know that for certain, of course, just yet.

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Eun Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [12]

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Okay. On hemolytic anemia, how many patients have been enrolled in this Stage 1 part of the Phase II? And when you present the data into this year, will it be all 17 patients?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [13]

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We think it will be all 17 patients. And it's later this year, so we'd rather wait on giving you an update on that until we're able to put a press release out about the status and reaffirm the timing. But for now, the goal is to enroll these patients and have the results by the end of the year.

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Operator [14]

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And our next question comes from the line of Josh Schimmer of Piper Jaffray.

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Maneka Mirchandaney, Piper Jaffray Companies, Research Division - Research Analyst [15]

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This is Maneka on for Josh. So on the FIT studies in ITP, what has the experience been with the responder patients that sought therapy for other reasons? Have they lost their platelet response? And if so, over what period of time?

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Anne-Marie S. Duliege, Rigel Pharmaceuticals, Inc. - Chief Medical Officer and EVP [16]

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So generally indeed, fostamatinib has a short duration of action. And so when patients stop fostamatinib for other reasons, adverse events or relocation or so, for the limited information we have because we do not follow these patients thereafter for too long term, we see a drop of platelet count, pretty much down to where they were at baseline.

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Operator [17]

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And our next question comes from the line of Anupam Rama of JPMorgan.

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Anupam Rama, JP Morgan Chase & Co, Research Division - VP and Analyst [18]

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Just 2 quick ones from me. Looking to EHA, what additional analysis should we be thinking about beyond what we learned in the top line data? And then as you look to a panel sort of later in the year or early next year, how are you guys preparing? And sort of what are the key questions you guys are thinking about?

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Anne-Marie S. Duliege, Rigel Pharmaceuticals, Inc. - Chief Medical Officer and EVP [19]

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The first question is in the EHA study, we're focused on 047, 048, mainly all the primary endpoints, some secondary endpoints and some of the adhoc endpoints as well. So you'll have a little bit more news around the description of the response. Your second question was?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [20]

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What are the questions we're working towards as we prepare for, say, an ODAC panel or from the FDA?

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Anne-Marie S. Duliege, Rigel Pharmaceuticals, Inc. - Chief Medical Officer and EVP [21]

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Definitely, we expect the FDA to ask us more questions about the safety profile of the drug, how it's compared with the background safety information that we had on rheumatoid arthritis. And by the way, there was obviously new, new signal in patients with ITP compared to the rheumatoid arthritis patients. We are preparing to answer the question about the duration of response and overall engaging to hopefully a dialogue with the FDA on the benefit/risk equation.

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [22]

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As you know, Anupam, preparing for managing the NDA process and interactions with the FDA take a tremendous amount of work. Some people think it's a tremendous amount of work to put the NDA together and submitted. It actually -- the work doesn't decrease after that. It frankly expands and it is a tremendous amount of effort.

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Operator [23]

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(Operator Instructions) And our next question comes from the line of Do Kim of BMO Capital Markets.

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Do Kim, BMO Capital Markets Equity Research - Analyst [24]

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I was hoping you could perhaps tell us what your expectations are in terms of FDA communications from now until the PDUFA date?

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [25]

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In terms of communications, I think there is regular communications as we hear from them on various topics. So it really could span anything that they may ask us questions at almost any time. In fact, it's even possible that they may have inspections at any time as well. So it really could be just about anything at any area. So we're working hard to effectively prepare for possible questions that they may shoot over at us. So we're expecting just about anything, to be honest with you, in terms of that. And that's fairly normal.

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Do Kim, BMO Capital Markets Equity Research - Analyst [26]

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Okay. And in the open-label portion of the ITP study, how much of that data has been submitted as part of the NDA? To what duration of treatment? And have you been seeing any loss of effect in the responders?

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Anne-Marie S. Duliege, Rigel Pharmaceuticals, Inc. - Chief Medical Officer and EVP [27]

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So we have provided the data as of -- last September was our cut date for the data. And some patients have been there for not quite a year, but others have been beyond a year or close to 2 years. So we had certainly a long duration of response for some of them. The response is generally maintained over time. Most of the patients stay on time generally. They are on target of platelets response.

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Do Kim, BMO Capital Markets Equity Research - Analyst [28]

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Okay. And a question for Ryan. What can we expect in terms of operating spend for the remainder of the year? Is the first quarter a sense of what's the run rate?

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Ryan D. Maynard, Rigel Pharmaceuticals, Inc. - CFO and EVP [29]

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Yes. I would say it is a good sense of run way -- run rate, sorry. The cost that we took in, in the first quarter that related to putting the NDA together, as Raul mentioned, there's a large effort underway to defend the NDA and to get ready for all of the inspections and work that is going on as we prepare for the potential Adcomm as well as the approval. So I would call the run rate of R&D in the first quarter to be a good measure as well as administrative line item as we start ramping the commercial organization and they get ready for the potential commercial launch.

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Operator [30]

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And I'm showing no further questions at this time. I would now like to turn the call over to Mr. Raul Rodriguez for closing remarks.

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Raul R. Rodriguez, Rigel Pharmaceuticals, Inc. - CEO, President and Director [31]

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So thank you all for your time and your questions. I think this has been a very productive quarter for the company and I think in total will be very exciting year for Rigel. We will continue to provide you updates on our regulatory milestones and our pipeline as appropriate. And with that, I wish you well, and thank you so much for your support.

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Operator [32]

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