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Rigel Reports Second Quarter 2024 Financial Results and Provides Business Update Second quarter total revenue of $36.8 million, which includes TAVALISSE net product sales of $26.4 million, REZLIDHIA net product sales of

Key Takeaway: Rigel Pharmaceuticals reported its financial results for the second quarter of 2024, showing total revenues of $36.8 million, boosted by significant sales of TAVALISSE and REZLIDHIA. Notably, REZLIDHIA experienced a 102% increase in net sales compared to the previous year. Despite these revenue gains, the company reported a net loss of $1.0 million and faced rising expenses associated with product sales and research. The integration of GAVRETO into their portfolio signifies a strategic advancement in their commercial operations.

Market Sentiment Analysis

POSITIVE FACTORS

  • Total revenue for Q2 2024 reached $36.8 million, marking a significant increase.
  • REZLIDHIA net product sales grew by 102% compared to the same period in 2023.
  • Successful transfer of GAVRETO to Rigel's commercial portfolio enhances treatment options.

CONCERNS & RISKS

  • The company reported a net loss of $1.0 million for Q2 2024, although improved from the previous year.
  • Expenses increased to $36.4 million, reflecting higher costs of product sales and R&D expenses.

Full Press Release Details

SAN FRANCISCO, Calif., August 6, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial
stage biotechnology company focused on hematologic disorders and cancer, today reported financial results for the second quarter ended
June 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.
the second quarter, we advanced key strategic initiatives including the successful transfer
of GAVRETO to our commercial portfolio, enabling us to bring this important treatment option
to current and newly prescribed patients without interruption," said Raul Rodriguez, Rigel's president and CEO. "The
addition of GAVRETO, combined with record revenues from TAVALISSE and REZLIDHIA, has allowed
us to approach net income break even. We look to maintain our financial discipline as we expand our commercial reach and advance
our development programs."
Quarter 2024 Business Update
TAVALISSE REZLIDHIA GAVRETO *
Bottles shipped to patients and clinics 2,672 424 -
Change in bottles remaining in distribution channel 50 (23 ) 228
Total bottles shipped 2,722 401 228
bottle count represents 60-count bottle equivalent
and Development Update
2024 and Year-To-Date Financial Update
quarter ended June 30, 2024, total revenues were $36.8 million, consisting of $26.4 million in TAVALISSE net product sales, $5.2
million in REZLIDHIA net product sales, $1.9 million in GAVRETO net product sales, and $3.4 million in contract revenue from collaborations.
TAVALISSE net product sales grew 24% compared to $21.3 million in the same period of 2023. REZLIDHIA net product sales grew 102% compared
to $2.6 million in the same period of 2023. GAVRETO became commercially available from Rigel on June 27, 2024. Contract revenue
from collaborations consisted of $2.2 million from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies,
$1.1 million from Grifols S.A. (Grifols) related to earned royalties, and $0.1 million from Medison Pharma Trading AG (Medison) related
to delivery of drug supplies and earned royalties.
expenses were $36.4 million compared to $32.2 million for the same period of 2023. The increase in costs and expenses was partly due
to higher cost of product sales, driven primarily by higher amortization of intangibles and royalties, increased personnel-related costs,
and increased research and development costs due to the progress of clinical activities, including R289, the company's IRAK
1/4 inhibitor program.
a net loss of $1.0 million, or $0.06 per basic and diluted share, compared to a net loss of $6.6 million, or $0.38 per basic and diluted
share, for the same period of 2023. The basic and diluted share and per share amounts have been restated to reflect the 1-for-10 reverse
stock split effected on June 27, 2024 on a retroactive basis for all periods presented.
For the six months ended June 30,
2024, total revenues were $66.4 million, consisting of $47.5 million in TAVALISSE net product sales, $10.0 million in REZLIDHIA net product
sales, $1.9 million in GAVRETO net product sales, and $6.9 million in contract revenue from collaborations. TAVALISSE net product sales
grew 9% compared to $43.6 million in the same period of 2023. REZLIDHIA net product sales grew 150% compared to $4.0 million in the same
period of 2023. As mentioned above, GAVRETO became commercially available from Rigel on June 27, 2024. Contract revenue from collaborations
consisted of $4.5 million from Kissei related to delivery of drug supplies, $2.2 million from Grifols related to earned royalties, and
$0.2 million from Medison related to delivery of drug supplies and earned royalties.
expenses were $72.9 million compared to $70.9 million for the same period of 2023. The increase in costs and expenses was partly due
to higher cost of product sales, driven primarily by higher amortization of intangibles and royalties, increased personnel-related costs
and higher stock-based compensation expenses mainly from performance awards. 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 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 warm
antibody hemolytic anemia (wAIHA).
a net loss of $9.3 million, or $0.53 per basic and diluted share, compared to a net loss of $20.1 million, or $1.16 per basic and diluted
share, for the same period of 2023. As discussed above, the share and per share amounts have been restated to reflect the 1-for-10 reverse
stock split on a retroactive basis for all periods presented.
Cash, cash equivalents
and short-term investments as of June 30, 2024 was $49.1 million, compared to $49.6 million as of March 31, 2024, and $56.9
million as of December 31, 2023.
and Webcast with Slides Today at 4:30pm Eastern Time
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.
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 there will be about 20,800
new cases in the United States, most in adults, in 2024.2
AML 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.
click here for Important Safety Information and Full Prescribing Information for
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.
click here for Important Safety Information and Full Prescribing Information, including
Boxed WARNING, for REZLIDHIA.
GAVRETO is 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).*
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).
click here for Important Safety Information and Full Prescribing Information
report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or
call 1-800-FDA-1088 (800-332-1088).
REZLIDHIA and GAVRETO are registered trademarks of Rigel Pharmaceuticals, Inc.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies
that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San
Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.
This press release contains forward-looking statements relating to, among other things, expected
commercial and financial results, expectations related to the potential and market opportunity of olutasidenib as a therapeutic
for R/R AML and other conditions, the commercialization of fostamatinib for cITP, the commercialization of pralsetinib for the treatment
of non-small cell lung cancer and advanced thyroid cancer, Rigel's ability to further develop its clinical stage product candidates
and Rigel's partnering and collaboration efforts, as well as the progress of the Phase 1b clinical trial of R289 for the treatment
of lower-risk myeloid dysplastic syndrome, olutasidenib's evaluation in acute myeloid leukemia (AML), including in patients
receiving prior venetoclax, and in other hematologic cancers, and including olutasidenib as a maintenance therapy following allogeneic

Frequently Asked Questions

What are Rigel Pharmaceuticals' latest financial results?

Rigel reported total revenues of $36.8 million for Q2 2024, increasing from previous periods.

When did GAVRETO become commercially available?

GAVRETO was commercially available from Rigel starting June 27, 2024.

What is TAVALISSE used to treat?

TAVALISSE (fostamatinib) treats chronic immune thrombocytopenia (ITP) in adults.

How did REZLIDHIA perform in sales growth?

REZLIDHIA sales grew by 102% to $5.2 million in Q2 2024 compared to 2023.

What key therapies does Rigel offer?

Rigel offers TAVALISSE, REZLIDHIA, and GAVRETO for various hematologic disorders and cancers.

Last updated: Aug 6, 2024