Full Press Release Details
Rigel Reports Second Quarter 2023 Financial Results and
Provides Business Update
| Second quarter 2023 Total Revenue of $26.9 million which includes TAVALISSE net product sales of $21.3 million and REZLIDHIA net product sales of $2.6 million | ||
| Development programs continue to advance with completion of target enrollment in cohort 2 of Phase 1b trial of R289 in lower-risk MDS and initiation of Phase 2a trial of R552 in rheumatoid arthritis by partner, Eli Lilly | ||
| Conference call and webcast scheduled today at 4:30 p.m. Eastern Time |
FRANCISCO, Calif., August 1, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for
the second quarter ended June 30, 2023, 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 and sales of REZLIDHIA (olutasidenib)
capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible
isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
"We are encouraged by the progress we made
in the second quarter in building our hematology/oncology company," said Raul Rodriguez, Rigel's president and CEO. "We delivered
strong year-over-year revenue growth for TAVALISSE in ITP and hired our dedicated institutional sales team to drive our commercial launch
of REZLIDHIA with a focus on awareness and education with healthcare professionals. We also continued to advance our current development
programs while evaluating opportunities to expand our hematology/oncology business through internal and external opportunities."
| In the second quarter of 2023, a total of 2,191 bottles of TAVALISSE were sold in the U.S. During the quarter, 2,265 bottles were shipped directly to patients and clinics, representing the highest number of bottles shipped to patients and clinics in a quarter since launch. | ||
| During the second full quarter of launch, a total of 200 bottles of REZLIDHIA were sold in the U.S., representing a 77% increase over Q1 2023. Of those bottles, 187 were shipped directly to patients and clinics. | ||
| In June, Rigel presented promising data from an analysis of the Phase 2 clinical trial evaluating REZLIDHIA in 17 patients with m IDH1 AML who were relapsed/refractory to prior venetoclax-based regimens at the European Hematology Association (EHA) 2023 Hybrid Congress. The data showed clinically meaningful activity with REZLIDHIA, a potent, selective, oral, small-molecule inhibitor of m IDH1 1 , representing an encouraging therapeutic advance in the treatment of this molecularly defined, poor-prognosis patient population. | ||
| Rigel also announced the publication in June of an expert review article in Blood Advances examining the development path and positioning of REZLIDHIA in the m IDH1 R/R AML treatment landscape. The authors concluded, "The approval of olutasidenib is a critical addition to the m IDH1 AML treatment landscape with encouragingly durable responses." They recommended treatment with olutasidenib in venetoclax plus HMA failures, based on the available data. | ||
| Rigel continues to advance its open-label, Phase 1b clinical trial of R289 2 , an investigational, potent, and selective IRAK1/4 inhibitor, in patients with lower-risk myeloid dysplastic syndrome (LR-MDS) who are refractory/resistant to prior therapies. Target enrollment in the second cohort of the trial has been completed and Rigel expects to begin enrollment in the third cohort in the near future. |
For the second quarter of 2023, Rigel reported a net loss
of $6.6 million, or $0.04 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted share,
for the same period of 2022.
For the second quarter of 2023, total revenues were $26.9
million, consisting of $21.3 million in TAVALISSE net product sales, $2.6 million in REZLIDHIA net product sales, $2.0 million in contract
revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $21.3 million increased
by $2.8 million or 15% compared to $18.6 million in the same period of 2022. Contract revenues from collaborations for the second quarter
of 2023 consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $1.2 million and a royalty of $0.8
million. Government contract revenue for the second quarter of 2023 was related to income recognized pursuant to the agreement with the
U.S. Department of Defense (DOD) to support Rigel's ongoing Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients
For the second quarter of 2023, total costs and expenses were
$32.2 million, compared to $42.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased
research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for wAIHA and
the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related
to Rigel's IRAK 1/4 inhibitor program.
For the six months ended June 30, 2023,
Rigel reported a net loss of $20.1 million, or $0.12 per basic and diluted share, compared to a net loss of $40.9 million, or $0.24 per
basic and diluted share, for the same period of 2022.
For the six months ended June 30, 2023, total revenues were
$52.9 million, consisting of $43.6 million in TAVALISSE net product sales, $4.0 million in REZLIDHIA net product sales, $4.3 million
in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $43.6 million
increased by $8.9 million or 26% compared to $34.7 million in the same period of 2022. Contract revenues from collaborations for the
six months ended June 30, 2023, consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $2.8 million
and a royalty of $1.5 million. Government contract revenue for the six months ended June 30, 2023, was related to the income recognized
pursuant to the previously mentioned agreement with the DOD.
For the six months ended June 30, 2023, total costs and expenses
were $70.9 million, compared to $85.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased
research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for wAIHA and
the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related
to Rigel's IRAK 1/4 inhibitor program.
As of June 30, 2023, Rigel had cash, cash equivalents and short-term
investments of $64.4 million, compared to $58.2 million as of December 31, 2022.
Conference Call and Webcast with Slides Today at 4:30pm Eastern
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) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed
from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for
replay after the call via the Rigel website.
In patients with ITP (immune thrombocytopenia),
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, blood platelet production
boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant
medical need for additional treatment options for patients with ITP.
Acute myeloid leukemia
(AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types
of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society
estimates that in the United States alone, there will be about 20,380 new cases, most in adults, in 2023.3
Relapsed AML affects
about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4
Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs
when a patient fails to achieve remission even after intensive treatment.5 Quality
of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory
disease remain an unmet need.
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
Please see www.TAVALISSEUSPI.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 and TAVLESSE are registered trademarks of Rigel Pharmaceuticals,
REZLIDHIA is indicated for the treatment of adult
patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected
by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION
Differentiation syndrome, which can be fatal,
can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension,
fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and
hemodynamic monitoring until symptom resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome.
In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients,
with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome
is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation
syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney
injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after
treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA
initiation and has been observed with or without concomitant leukocytosis.
If differentiation syndrome is suspected, temporarily
withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until