Rigel Announces Second Quarter 2019 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif., Aug. 6, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today reported financial results for the second quarter ended June 30, 2019, including sales of TAVALISSE® (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
"Execution is the key to Rigel's success, and has enabled us to increase awareness of the benefits of TAVALISSE for chronic ITP as seen by the 26% growth in net product sales quarter over quarter," stated Raul Rodriguez, president and CEO. "Our commercial team continues to drive uptake of our product and the interest level among the patient and physician communities is very encouraging. In parallel, our pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia is underway and enrolling patients. With the only warm AIHA treatment in a Phase 3 trial and no FDA-approved therapy for the indication, this is a substantial opportunity for Rigel."
Financial Update
For the second quarter of 2019, Rigel reported a net loss of $20.6 million, or $0.12 per share, compared to a net loss of $25.6 million, or $0.16 per share, in the same period of 2018.
For the second quarter of 2019, Rigel reported net product sales from TAVALISSE of $10.2 million, compared to $1.8 million in the same period of 2018. The increase in net product sales reflects the expansion of TAVALISSE use since its commercial launch in May 2018.
Contract revenues from collaborations were $234,000 for the three months ended June 30, 2019, which were related to Rigel's collaboration agreements with Kissei Pharmaceutical Co., Ltd. and Grifols, S.A. There were no contract revenues from collaborations during the three months ended June 30, 2018.
Rigel reported total costs and expenses of $31.7 million in the second quarter of 2019, compared to $27.9 million for the same period in 2018. The increase in costs and expenses was primarily due to increased personnel costs for Rigel's customer-facing team and third-party costs related to Rigel's commercial launch of TAVALISSE in chronic ITP, as well as research and development costs related to its Phase 3 pivotal trial of TAVALISSE in patients with warm AIHA.
For the six months ended June 30, 2019, Rigel reported a net loss of $38.2 million, or $0.23 per share, compared to a net loss of $49.9 million, or $0.32 per share, for the same period of 2018.
Rigel reported total revenues of $23.0 million for the six months ended June 30, 2019, compared to $1.8 million for the same period in 2018. Total revenues for the six months ended June 30, 2019 consisted of $18.2 million in net product sales and $4.8 million in revenue related to Rigel's collaboration agreements with Grifols and Kissei. Total revenues for the six months ended June 30, 2018 consisted of $1.8 million in net product sales. There were no contract revenues from collaborations for the six months ended June 30, 2018.
Total costs and expenses for the six months ended June 30, 2019 were $62.7 million, compared to $52.6 million, for the same period of 2018. The increase in total costs and expenses was primarily related to the increase in personnel costs for Rigel's customer-facing team, as well as third party costs related to Rigel's ongoing commercialization of TAVALISSE in chronic ITP.
As of June 30, 2019, Rigel had cash, cash equivalents and short-term investments of $112.4 million, compared to $128.5 million as of December 31, 2018.
Business Update
-- Sales of TAVALISSE have achieved consecutive double-digit quarterly
growth since product launch in May of 2018. This reflects an increase in
prescribers, a broadening awareness among patients and physicians,
growing early line use, and continued strong refill rates.
-- Rigel has received the EMA's 180-day questions related to the European
marketing authorization application (MAA) for fostamatinib in chronic
ITP. The approval process remains on track for a potential EMA decision
by the end of this year.
-- The first patients have been enrolled in FORWARD (Fostamatinib Research
in Warm Antibody AIHA Disease), Rigel's pivotal Phase 3 clinical trial
in warm AIHA. The addition of clinical trial sites is ramping. Topline
results are expected in mid 2021, positioning TAVALISSE to potentially
become the first FDA-approved treatment for warm AIHA.
-- At the 2019 Congress of the European Hematology Association (EHA), Rigel
presented TAVALISSE data supporting its ability to improve the lives of
patients with chronic ITP and highlighting its clinical trial progress
in warm AIHA. These data were presented in two posters which highlighted
long-term safety and efficacy results of TAVALISSE in a Phase 3
extension study for the treatment of chronic ITP, as well as a Phase 2
open-label extension study in patients with warm AIHA.
-- Rigel plans to provide data from its Phase 1 trial of R835(1), an IRAK
1/4 inhibitor, in the second half of 2019.
-- The company continues to explore additional opportunities to expand its
pipeline, which includes pursuing other indications for TAVALISSE to
take advantage of the anticipated product exclusivity until 2031.
About ITP
In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, platelet production amplifiers (TPO-RAs - thrombopoietin receptor agonists), and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About AIHA
AIHA is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.
About R835(1
)The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the FDA or any healthcare authority.
Conference Call and Webcast with Slides Today at 4:30PM Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).
Participants can access the live conference call by dialing (877) 407-8309 (domestic) or (201) 689-8057 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel's website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.
About TAVALISSE
Indication
TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Important Safety Information
Warnings and Precautions
-- Hypertension can occur with TAVALISSE treatment. Patients with
pre-existing hypertension may be more susceptible to the hypertensive
effects. Monitor blood pressure every 2 weeks until stable, then
monthly, and adjust or initiate antihypertensive therapy for blood
pressure control maintenance during therapy. If increased blood pressure
persists, TAVALISSE interruption, reduction, or discontinuation may be
required.
-- Elevated liver function tests (LFTs), mainly ALT and AST, can occur with
TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase
to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE
interruption, reduction, or discontinuation.
-- Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1%
of patients treated with TAVALISSE. Monitor patients for the development
of diarrhea and manage using supportive care measures early after the
onset of symptoms. If diarrhea becomes severe (>=Grade 3), interrupt,
reduce dose or discontinue TAVALISSE.
-- Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile
neutropenia occurred in 1% of patients. Monitor the ANC monthly and for
infection during treatment. Manage toxicity with TAVALISSE interruption,
reduction, or discontinuation.
-- TAVALISSE can cause fetal harm when administered to pregnant women.
Advise pregnant women the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception during treatment
and for at least 1 month after the last dose. Verify pregnancy status
prior to initiating TAVALISSE. It is unknown if TAVALISSE or its
metabolite is present in human milk. Because of the potential for
serious adverse reactions in a breastfed child, advise a lactating woman
not to breastfeed during TAVALISSE treatment and for at least 1 month
after the last dose.
Drug Interactions
-- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases
exposure to the major active metabolite of TAVALISSE (R406), which may
increase the risk of adverse reactions. Monitor for toxicities that may
require a reduction in TAVALISSE dose.
-- It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as
concomitant use reduces exposure to R406.
-- Concomitant use of TAVALISSE may increase concentrations of some CYP3A4
substrate drugs and may require a dose reduction of the CYP3A4 substrate
drug.
-- Concomitant use of TAVALISSE may increase concentrations of BCRP
substrate drugs (e.g., rosuvastatin) and P-Glycoprotein (P-gp) substrate
drugs (e.g., digoxin), which may require a dose reduction of the BCRP
and P-gp substrate drug.
Adverse Reactions
-- Serious adverse drug reactions in the ITP double-blind studies were
febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which
occurred in 1% of TAVALISSE patients. In addition, severe adverse
reactions occurred including dyspnea and hypertension (both 2%),
neutropenia, arthralgia, chest pain, diarrhea, dizziness,
nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all
1%).
-- Common adverse reactions (>=5% and more common than placebo) from FIT-1
and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and
AST increased, respiratory infection, rash, abdominal pain, fatigue,
chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.
To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate), the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel's current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA) and an ongoing Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program. In addition, Rigel has product candidates in clinical development with partners BerGenBio ASA, Daiichi Sankyo, Aclaris Therapeutics, and AstraZeneca.
(1 )The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.
Forward Looking Statements
This release contains forward-looking statements relating to, among other things, Rigel's ability to drive interest in and sales of TAVALISSE; the potential for fostamatinib in ITP to obtain approval in the EU by the end of 2019; expectations related to the market opportunity for ITP; Rigel's ability to broaden its pipeline; and the design, timing and results of Rigel's clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "planned," "will," "may," "expect," "anticipate," and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the period ended March 31, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
RIGEL PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2019 2018 2019 2018
(unaudited)
Revenues:
Product sales, net $10,173 $1,787 $18,227 $1,787
Contract revenues from collaborations 234 4,804
Total revenues 10,407 1,787 23,031 1,787
Costs and expenses:
Cost of product sales 311 30 418 30
Research and development (see Note A) 13,226 10,797 24,175 22,039
Selling, general and administrative (see Note A) 18,209 17,071 38,155 30,563
Total costs and expenses 31,746 27,898 62,748 52,632
Loss from operations (21,339) (26,111) (39,717) (50,845)
Interest income 733 554 1,513 903
Net loss $(20,606) $(25,557) $(38,204) $(49,942)
===
Net loss per share, basic and diluted $(0.12) $(0.16) $(0.23) $(0.32)
===
Weighted-average shares used in computing net loss per share, basic and diluted 167,191 161,577 167,182 154,385
Note A
Stock-based compensation expense included in:
Selling, general and administrative $1,742 $779 $3,908 $1,719
Research and development 911 333 1,698 933
$2,653 $1,112 $5,606 $2,652
SUMMARY BALANCE SHEET DATA
(in thousands)
June 30,
December 31,
2019
2018 (1)
(unaudited)
Cash, cash equivalents and short-term investments $112,377 $128,537
Total assets 156,158 139,109
Stockholders' equity 78,291 109,877
(1)
Derived from audited financial statements
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SOURCE Rigel Pharmaceuticals, Inc.
