RIGL - NASDAQ
Rigel Pharmaceuticals, Inc.
RIGL·NASDAQ
$30.30
+0.93%HealthcareBiotechnology
Rigel Pharmaceuticals, Inc., a biotechnology company, discovers and develops small molecule drugs to treat hematologic disorders, cancer, and rare immune diseases. The company offers Tavalisse, an oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia. It also develops Fostamatinib that is in phase III clinical trial for the treatment of warm autoimmune hemolytic anemia; phase III clinical trial for the treatment of hospitalized COVID-19 patients; and phase III clinical trial for the treatment of COVID-19. In addition, the company is developing R289, an oral interleukin receptor associated kinase 1/4 inhibitor, which is in phase I clinical trial for autoimmune, inflammatory, and hematology-oncology diseases; and R552, a receptor-interacting serine/threonine-protein kinase 1 inhibitor that has completed phase I clinical trial for autoimmune and inflammatory diseases. It has research and license agreements with AstraZeneca AB for the development and commercialization of R256, an inhaled JAK inhibitor; BerGenBio AS for the development and commercialization of AXL inhibitors in oncology; and Daiichi Sankyo to develop murine double minute 2 inhibitors for solid and hematological malignancies, as well as license and supply agreement with Kissei Pharmaceutical Co., Ltd. to develop and commercialize Fostamatinib. The company also has a license agreement and strategic collaboration with Eli Lilly and Company to co-develop and commercialize R552 for various indications, including autoimmune and inflammatory diseases, as well as other non-central nervous system (non-CNS) disease development candidates. Rigel Pharmaceuticals, Inc. was incorporated in 1996 and is headquartered in South San Francisco, California.
At a Glance
Live SnapshotMarket Cap$560.61M
EPS20.4000
P/E Ratio1.49
Earnings Date08/04/2026
Earnings Call Transcript
RIGL • 2023 • Q3
Operator
Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Third Quarter of 2023. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey, Rigel's Executive Vice President, General Counsel and Corporate Secretary. Thank you, Mr. Furey, you may begin.
Ray Furey
Welcome to our third quarter 2023 financial results and business update conference call. The financial press release for the third quarter 2023 was issued a short while ago and can be viewed along with the slides of this presentation in the News and Events section of our Investor Relations site on rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Annual Report on Form 10-K for the year ended December 31, 2022, and subsequent filings with the SEC, including our third quarter 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 President and Chief Executive Officer, Raul Rodriguez. Raul?
Raul Rodriguez
Thank you, Ray, and thank you, everyone, for joining today. Also with me today are Dave Santos, our Chief Commercial Officer; and Dean Schorno, our Chief Financial Officer. Let me begin on slide 4. The third quarter was an important one for Rigel, one in which we made meaningful progress on growing the sales of our commercial products. This growth, coupled with tight financial discipline allowed us to make important progress on our plans to reach financial breakeven. We review the components of this during today's presentation. Regarding product sales. In the third quarter, we delivered a robust performance for our first approved product, TAVALISSE, for adult chronic ITP. Demand bottles shipped to patients and clinics reached a new quarterly record since launch. We grew net product sales by 15% quarter-over-quarter and 27% year-over-year. We are pleased with the continued momentum that our team is generating for TAVALISSE. For our second approved product, RE
Dave Santos
Thank you, Raul. Now I'd like to take a few minutes to discuss our continued growth of TAVALISSE during another sequential record quarter and our progress with the RE
Raul Rodriguez
Thank you, Dave. I will now summarize our expansion plans for olutasidenib and provide updates on our other development programs. Beginning on Slide 18. We like the growth of our commercial business, and we want to expand our business even further. There are two ways of accomplishing these. First, there is the potential to grow our current products with new supportive data and particularly, with new indications. In addition, there is the potential for in-licensing of new products. Based on an in-depth review, we believe that olutasidenib has potential in numerous cancers where mutant IDH1 plays a role. We see additional segments in AML, Glioma and MDS is promising indications for olutasidenib. Fostamatinib also has potential in other heme/onc indications, and we will provide additional data through investigator-sponsored trials rather than through our own trials, as we think this is the best use of our resources. Any investments in new development opportunities will be focused and cost-efficient and can be funded by our own operations. As part of this, we expect to work with academic centers and government partners on these strategic efforts. Moving on to the right side of this slide. The in-licensing of RE
Dean Schorno
Thank you, Raul. I'm on Slide 24. For the third quarter of 2023, we shipped 2,551 bottles with TAVALISSE to our specialty distributors, resulting in $35.2 million of gross product sales. 2,412 bottles of TAVALISSE were shipped to patients and clinics, while 139 bottles increased the levels remaining in our distribution channels at the end of the quarter. For the third quarter of 2023, we shipped 210 bottles of RE
Raul Rodriguez
Thank you, Dean. We are proud of the progress we have made so far in 2023 with TAVALISSE sales delivering another strong quarter marked by continued growth. We are executing on our launch of RE
Raul Rodriguez
I'll ask Ray to answer the first question on TAVALISSE exclusivity in the US and elsewhere.
Ray Furey
Yes. We have a composition of matter patent for TAVALISSE that is with PTA and PTE is expected to run until September of 2031. I'd have to check and get back to you on exclusivity in Japan and elsewhere
Raul Rodriguez
I think it's comparable or similar
Ray Furey
It is comparable. I don't have the exact dates.
Ray Furey
On RE
Dave Santos
Yes. From a standpoint of RE
Raul Rodriguez
Thank you.
Operator
Thank you. The next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.
Unidentified Analyst
Hi. This is Rick Miller [ph] on for Kristen. Thanks for taking our questions. Given the commercial strategy, sort of dovetailing TAVALISSE with RE
Raul Rodriguez
Good question, Rick. Thank you. Dave, do you want to comment?
Dave Santos
Yes, I will say – we are bringing our entire institutional team to ASH because we do think it's an important opportunity for them to interact with their customers. The fact is most important hematology treaters attend ASH. And so it's a very specific audience, especially AML treaters. And so we will be deploying our team there.
Raul Rodriguez
Rick, a year ago, we got the product approved just days before the ASH meeting. And it's remarkable, we were able to be ready and have information in there on the booth on RE
Unidentified Analyst
Great. And maybe just one follow-up with the ASH abstracts, specifically the MDS analysis. Can you talk a little bit about how you're thinking about the IDH1 positive prevalence in the MDS population and how this relates to what you're seeing in AML. Thank you and looking forward to seeing the team in San Diego.
Raul Rodriguez
Yes, I'll comment. Dave, do you want to comment as well. MDS is an attractive opportunity. We've seen IDH1 inhibitors work in this area. So it provides some exciting opportunities. Just to remind you, in the Phase 2 study done by our colleagues in pharma, it included patients with MDS. So we have some idea on that opportunity already with, I think, 22 patients
Dave Santos
In the abstract presented at [indiscernible]. And just, Rick, could you just repeat the first part of your question? I just want to make sure I got that right.
Unidentified Analyst
Yes, more around prevalence and just sort of market size in the MDS population versus AML.
Raul Rodriguez
I don't have those specifics right here with me, but it is a smaller population than the AML population.
Raul Rodriguez
Yes, just smaller, but I think the percentage of IDH positive is a bit higher than in AML. So -- but it's still a smaller population on the whole.
Unidentified Analyst
Great. Okay. Thank you, very much.
Raul Rodriguez
Thank you, Rick
Raul Rodriguez
Dave, do you want to comment on RE
Dave Santos
Yes. So if you're looking at our total bottle shift in Q3. Obviously, the majority of those were carryover from previous. I'd have to -- let me say here. It's probably generally, maybe two-thirds to three quarters carryover and about a quarter to one-third is new. And again, that always depends on when you get those new patients. We got our new patients, a lot of them, as I said, in September. So that's why I think that number is like the -- or is the way it is. So I hope that makes sense but the majority this quarter was carryover. And again, a lot of that is because our new patients really -- because it is kind of lumpy, showed up in September. Coming on your second question in terms of share of those, if you do this, you're talking about maybe 250 patients a quarter, you heard from our first quarter on launch, we were around 30 patients. So we think we're probably in that double-digit share of incident new patients.
Raul Rodriguez
And on the label expansion priority, all three of those that I mentioned, and there are others, in fact, in other segments of AML, in Glioma and MDS are attractive and different one to the other. AML, we know the product works and has shown a benefit in the relapsed or refractory setting. Obviously, other opportunities within that patient's maintenance in first-line are things that we're thinking about. In addition, Glioma is a sizable, sizable opportunity, and just so poorly, poorly treated today. That is a very exciting opportunity, a larger opportunity perhaps. And MDS, while smaller, as we mentioned just a minute ago, an area with significant medical need as well, both in low-risk and high-risk MDS. So there really is a highly varied array of different opportunities for olutasidenib. And clearly, we are going to focus on a subset of those and do so in a focused, efficient cost-wise manner, perhaps in some cases, with academic and government partners.
Unidentified Analyst
Okay. Great. That's helpful. Thank you very much.
Operator
Thank you. The next question is from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.
Joe Pantginis
Hey, everybody. Good afternoon. Thanks for taking the questions. So I was curious, first, I wanted to go back to TAVALISSE patient populations? And I guess I'll ask the question, but I don't know if you have this level of granularity in the data you collect. So in the second line or moving to second-line patients, do you have data that show, for example, patients that are -- that you're replacing TPOs or say you're prescribing TAVALISSE in lieu of TPOs. Do you have that level of granularity that or say RITUXAN?
Ray Furey
Dave.
Dave Santos
Well, just to be clear, where our data comes from is rock. We actually -- because we have those histories, we know what line of therapy that is. So we don't -- but we don't have is kind of what they would have intended to use. So we're mixing two kind of different things there. The data that we are sharing in terms of 30% of those patients that are going through rock, our second line but we don't know what they would have used had they not chosen TAVALISSE. Does that make sense?
Joe Pantginis
Yes. It does.
Dave Santos
So from our ATU, I think those clinicians who do use it second line, those are clinicians who've had experience with TAVALISSE like how TAVALISSE works and they just -- they tend to move it up because it's very predictable. So that's probably the best way I can say it. I don't want to jump to any conclusions about where our second line business is coming from in terms of what product they would have chosen.
Joe Pantginis
No, that's completely fair. I appreciate that. And then with regard to RE
Dave Santos
No, I wouldn't say we have anything that indicates. Look, this is a class effect. It's a black box warning across the class, both with FLT3 inhibitors as well as IDH1 inhibitors 90H2. So, it's a class effect in that. We have not heard anything or have reason to believe that our differentiation syndrome would be a differentiator for RE
Joe Pantginis
Great. Appreciate the color. Thank you very much.
Operator
Thank you. There are no further questions at this time. And I would like to turn the floor back over to Mr. Raul Rodriguez for closing comments.
Raul Rodriguez
Thank you. This quarter was a really very good one. We grew our products very nicely and we're happy with that. We made progress on our financial goals as well. So, we're very pleased where we are. So with that, I'd like to close by thanking every one of you for your continued interest and support of Rigel. And as always, I'd like to thank our employees for their commitment to improving the lives of patients. They work hard every single day. And with that, I look forward to updating you on future calls. Have a great day.
Transcript from November 7, 2023
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