Full Press Release Details
Rigel Reports Third Quarter 2024 Financial Results
and Provides Business Update
| Third quarter total revenue of $55.3 million, which includes TAVALISSE net product sales of $26.3 million, REZLIDHIA net product sales of $5.5 million and GAVRETO net product sales of $7.1 million | ||
| Entered into an agreement with Kissei to develop and commercialize REZLIDHIA in all potential indications in Japan, the Republic of Korea and Taiwan, recording an upfront cash payment of $10.0 million during the third quarter | ||
| Initial data from the ongoing Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, in LR-MDS to be presented at the 66 th ASH Annual Meeting | ||
| Conference call and webcast scheduled today at 4:30 p.m. Eastern Time |
SOUTH SAN FRANCISCO,
Calif., November 7, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology
company focused on hematologic disorders and cancer, today reported financial results for the third quarter ended September 30, 2024,
including sales of TAVALISSE (fostamatinib disodium
hexahydrate) for the treatment of chronic immune thrombocytopenia (ITP); REZLIDHIA (olutasidenib)
for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML);
and GAVRETO (pralsetinib)
for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and advanced or
metastatic thyroid cancer, and recent business progress.
been a significant year for Rigel, marked by the acquisition of GAVRETO, our third commercial product, strong revenue growth across our
commercial portfolio, and the advancement of our development pipeline," said Raul Rodriguez, Rigel's president and
CEO. "This great progress is underpinned by our focus on financial discipline, resulting in
positive third-quarter and year-to-date net income. As we close out the year, we will continue driving momentum in our commercial portfolio
and hematology and oncology development pipeline."
2024 Business Update
| Commercial strength continues for all products with record bottles shipped to patients and clinics and total bottles sold. | ||
| GAVRETO became commercially available from Rigel in June 2024. Third-quarter results reflect the successful transition of existing patients on therapy to Rigel's product. For the fourth quarter, the focus will be on continuing to transition patients. | ||
| The following table summarizes total bottles shipped for the third quarter: |
| TAVALISSE | REZLIDHIA | GAVRETO * | ||||||||||
| Bottles shipped to patients and clinics | 2,797 | 444 | 717 | |||||||||
| Change in bottles remaining in distribution channel | (4 | ) | (15 | ) | 35 | |||||||
| Total bottles shipped | 2,793 | 429 | 752 |
bottle count represents 60-count bottle equivalent
and Development Update
| Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 1 , a novel and selective dual IRAK1/4 inhibitor, in patients with R/R lower-risk myelodysplastic syndrome (LR-MDS). Enrollment in the fifth dose level (500mg / 250mg split dose) is underway. | |
| In early November, Rigel announced six poster presentations highlighting data from the company's commercial and clinical-stage hematology and oncology portfolio at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition. Initial data from the ongoing Phase 1b study evaluating R289 in patients with R/R LR-MDS indicate that R289 was generally well tolerated in a heavily pretreated LR-MDS patient population, the majority of whom were high transfusion burden at study entry. As of the data cutoff, 14 of 19 patients were evaluable for efficacy and per International Working Group (IWG) 2018, RBC-transfusion independence (RBC-TI)/hematologic improvement (HI-E) occurred in 36% of patients receiving R289 doses 500 mg QD, with a median duration of RBC-TI of 29 weeks. RBC-TI >24 weeks was achieved in 2 high transfusion burden patients following 3 and 5 prior therapies, including a hypomethylating agent. The company will also present additional data for olutasidenib in patients with R/R m IDH1 AML and MDS. | |
| In September, Rigel announced the first patient was enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA in patients with m IDH1 AML, which is being sponsored and conducted by The University of Texas MD Anderson Cancer Center (MD Anderson). This is the first trial in Rigel's multi-year strategic development alliance with MD Anderson. | |
| A paper detailing the differences in molecular structure, binding characteristics and clinical outcomes between olutasidenib and ivosidenib, including response rates in patients previously treated with ivosidenib or venetoclax, was published by Dr. Justin M. Watts, Associate Professor of Medicine, Division of Hematology, Chief, Leukemia Section at the University of Miami Health System, in Current Treatment Options in Oncology in October 2024. |
Third Quarter 2024 and Year-To-Date Financial
For the third quarter ended September 30,
2024, total revenues were $55.3 million, consisting of $26.3 million in TAVALISSE net product sales, $5.5 million in REZLIDHIA net product
sales, $7.1 million in GAVRETO net product sales, and $16.4 million in contract revenue from collaborations. TAVALISSE net product sales
grew 8% compared to $24.5 million in the same period of 2023. REZLIDHIA net product sales grew 107% compared to $2.7 million in the same
period of 2023. GAVRETO became commercially available from Rigel in June 2024. Contract revenue from collaborations consisted of
$13.0 million from Kissei Pharmaceutical Co., Ltd. (Kissei) related to an upfront fee from sublicensing olutasidenib and delivery
of drug supplies, as well as $3.3 million from Grifols S.A. (Grifols) and $0.1 million from Medison Pharma Trading AG (Medison) related
to delivery of drug supplies and earned royalties.
Total costs and expenses were $41.3 million
compared to $32.6 million for the same period of 2023. The increase in costs and expenses was mainly due to higher cost of product sales,
driven primarily by increased products sales, a sublicensing revenue fee to Forma, increased royalties and amortization of intangible
assets. In addition, there were increases in personnel-related costs and commercial-related expenses.
Rigel reported net income of $12.4 million,
or $0.71 basic and $0.70 diluted per share, compared to a net loss of $5.7 million, or $0.33 basic and diluted per share, for the same
period of 2023. The basic and diluted share and per share amounts for the prior period have been restated to reflect the 1-for-10 reverse
stock split effected on June 27, 2024 on a retroactive basis.
For the nine months ended September 30, 2024, total revenues were
$121.7 million, consisting of $73.8 million in TAVALISSE net product sales, $15.6 million in REZLIDHIA net product sales, $9.0 million
in GAVRETO net product sales, and $23.3 million in contract revenue from collaborations. TAVALISSE net product sales grew 8% compared
to $68.1 million in the same period of 2023. REZLIDHIA net product sales grew 133% compared to $6.7 million in the same period of 2023.
As mentioned above, GAVRETO became commercially available from Rigel in June 2024. Contract revenue from collaborations consisted
of $17.5 million from Kissei related to an upfront fee from sublicensing olutasidenib and delivery of drug supplies, as well as $5.5 million
from Grifols and $0.2 million from Medison related to delivery of drug supplies and earned royalties.
Total costs and expenses were $114.1 million
compared to $103.5 million for the same period of 2023. The increase in costs and expenses was mainly due to higher cost of product sales
driven primarily by increased products sales, a sublicensing revenue fee to Forma, increased royalties and amortization of intangible
assets. In addition, there were increases in personnel-related costs, stock-based compensation expense and commercial-related expenses.
These increases were partially offset by decreased research and development costs due to the timing of clinical trial activities related
to R289, the company's dual IRAK 1/4 inhibitor program, as well as reduced trial activities related to the completed Phase 3 clinical
trials of fostamatinib in patients with COVID-19 and in patients with warm antibody hemolytic anemia (wAIHA).
Rigel reported net income of $3.1 million,
or $0.18 basic and diluted per share, compared to a net loss of $25.8 million, or $1.49 basic and diluted per share, for the same period
of 2023. As discussed above, the share and per share amounts for the prior period have been restated to reflect the 1-for-10 reverse stock
split on a retroactive basis for the periods presented.
Cash, cash equivalents and short-term investments
as of September 30, 2024 was $61.1 million, compared to $49.1 million as of June 30, 2024, and $56.9 million as of December 31,
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).
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.
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 there will be about 20,800 new cases in the United States, most in adults, in 2024.2
affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 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.4 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.
It is estimated that over 230,000 adults in the U.S. will be diagnosed with lung cancer in 2024. Lung cancer is the leading
cause of cancer death in the U.S, with NSCLC being the most common type accounting for 80-85% of all lung cancer diagnoses.5 RET
fusions are implicated in approximately 1-2% of patients with NSCLC.6
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.
here for Important Safety Information and Full Prescribing Information for TAVALISSE.
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.
Please click here for
Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.
indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung
cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic
RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*
*Thyroid indication is approved
under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in confirmatory trial(s).
Please click here for
Important Safety Information and Full Prescribing Information for GAVRETO.
effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or
call 1-800-FDA-1088 (800-332-1088).
TAVALISSE, REZLIDHIA and GAVRETO