TG Therapeutics, Inc. (NASDAQ: TGTX) yesterday announced
preliminary U.S. net product revenue for BRIUMVI® for the fourth
quarter and full year ended December 31, 2023 (unaudited), as well
as financial guidance and development milestones for 2024, during a
preannounced presentation at the 42nd Annual J.P Morgan Healthcare
Conference. An audio replay of the event, as well as the
corresponding slide deck are available on the Investors and Media
section of the TG corporate website at
ir.tgtherapeutics.com/events.
Michael S. Weiss, Chairman and Chief Executive Officer of TG
Therapeutics stated, “We are excited to share our preliminary
fourth quarter and year end U.S. BRIUMVI net product revenue. As we
head into 2024, we have our sights set on achieving revenue and
expense targets and have built an ambitious plan to potentially
expand the utility of BRIUMVI into new indications and for use as a
subcutaneous injection. We are also excited to expand our R&D
program with the recent licensing of azer-cel, an allogeneic CD19
CAR T therapy which we believe has the potential to become a
meaningful therapy to treat various autoimmune disorders.”
Preliminary Fourth Quarter and Full Year 2023 Updates
(based on unaudited financial information)
- BRIUMVI U.S. net product revenue
expected to be approximately $40 million and $89 million for the
fourth quarter and full year of 2023, respectively
- Year-end 2023 cash position of
approximately $215 million
Preliminary selected financial information presented in this
release are unaudited, subject to financial closing procedures and
adjustment, and provided as an approximation in advance of the
Company’s announcement of complete financial results planned to
occur February 2024.
2024 Target Guidance
- BRIUMVI U.S. net product revenue
targets of approximately $41-$46 million and $220-$260 million for
the first quarter and full year 2024, respectively
- Full year 2024 target operating
expense of approximately $250 million
2024 Development Pipeline Anticipated
Milestones
- Commence clinical development of
subcutaneous BRIUMVI
- Commence a trial evaluating BRIUMVI
in additional autoimmune diseases outside of Multiple Sclerosis
(MS)
- Commence a trial evaluating
azer-cel in autoimmune disease
- Present data from the ENHANCE Phase
3b CD20 switch trial at multiple conferences throughout the
year
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection
for IVBRIUMVI is a novel monoclonal antibody that targets
a unique epitope on CD20-expressing B-cells. Targeting CD20 using
monoclonal antibodies has proven to be an important therapeutic
approach for the management of autoimmune disorders, such as
relapsing forms of multiple sclerosis (RMS). BRIUMVI is uniquely
designed to lack certain sugar molecules normally expressed on the
antibody. Removal of these sugar molecules, a process called
glycoengineering, allows for efficient B-cell depletion at low
doses.
BRIUMVI is indicated for the treatment of adults with RMS, to
include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease.
A list of authorized specialty distributors can be found at
www.briumvi.com.
IMPORTANT SAFETY
INFORMATIONContraindications: BRIUMVI is
contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion
reactions, which can include pyrexia, chills, headache,
influenza-like illness, tachycardia, nausea, throat irritation,
erythema, and an anaphylactic reaction. In MS clinical trials, the
incidence of infusion reactions in BRIUMVI-treated patients who
received infusion reaction-limiting premedication prior to each
infusion was 48%, with the highest incidence within 24 hours of the
first infusion. 0.6% of BRIUMVI-treated patients experienced
infusion reactions that were serious, some requiring
hospitalization.
Observe treated patients for infusion reactions during the
infusion and for at least one hour after the completion of the
first two infusions unless infusion reaction and/or
hypersensitivity has been observed in association with the current
or any prior infusion. Inform patients that infusion reactions can
occur up to 24 hours after the infusion. Administer the recommended
pre-medication to reduce the frequency and severity of infusion
reactions. If life-threatening, stop the infusion immediately,
permanently discontinue BRIUMVI, and administer appropriate
supportive treatment. Less severe infusion reactions may involve
temporarily stopping the infusion, reducing the infusion rate,
and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal,
bacterial and viral infections have been reported in
BRIUMVI-treated patients. In MS clinical trials, the overall rate
of infections in BRIUMVI-treated patients was 56% compared to 54%
in teriflunomide-treated patients. The rate of serious infections
was 5% compared to 3% respectively. There were 3 infection-related
deaths in BRIUMVI-treated patients. The most common infections in
BRIUMVI-treated patients included upper respiratory tract infection
(45%) and urinary tract infection (10%). Delay BRIUMVI
administration in patients with an active infection until the
infection is resolved.
Consider the potential for increased immunosuppressive effects
when initiating BRIUMVI after immunosuppressive therapy or
initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV
reactivation occurred in an MS patient treated with BRIUMVI in
clinical trials. Fulminant hepatitis, hepatic failure, and death
caused by HBV reactivation have occurred in patients treated with
anti-CD20 antibodies. Perform HBV screening in all patients before
initiation of treatment with BRIUMVI. Do not start treatment with
BRIUMVI in patients with active HBV confirmed by positive results
for HBsAg and anti-HB tests. For patients who are negative for
surface antigen [HBsAg] and positive for HB core antibody [HBcAb+]
or are carriers of HBV [HBsAg+], consult a liver disease expert
before starting and during treatment.
Progressive Multifocal Leukoencephalopathy
(PML): Although no cases of PML have occurred in
BRIUMVI-treated MS patients, JCV infection resulting in PML has
been observed in patients treated with other anti-CD20 antibodies
and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate
diagnostic evaluation. Typical symptoms associated with PML are
diverse, progress over days to weeks, and include progressive
weakness on one side of the body or clumsiness of limbs,
disturbance of vision, and changes in thinking, memory, and
orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms;
monitoring for signs consistent with PML may be useful. Further
investigate suspicious findings to allow for an early diagnosis of
PML, if present. Following discontinuation of another MS medication
associated with PML, lower PML-related mortality and morbidity have
been reported in patients who were initially asymptomatic at
diagnosis compared to patients who had characteristic clinical
signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be
discontinued.
Vaccinations: Administer all immunizations
according to immunization guidelines: for live or live-attenuated
vaccines at least 4 weeks and, whenever possible at least 2 weeks
prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may
interfere with the effectiveness of non-live vaccines. The safety
of immunization with live or live-attenuated vaccines during or
following administration of BRIUMVI has not been studied.
Vaccination with live virus vaccines is not recommended during
treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with
BRIUMVI During Pregnancy: In infants of mothers exposed to
BRIUMVI during pregnancy, assess B-cell counts prior to
administration of live or live-attenuated vaccines as measured by
CD19+ B-cells. Depletion of B-cells in these infants may increase
the risks from live or live-attenuated vaccines. Inactivated or
non-live vaccines may be administered prior to B-cell recovery.
Assessment of vaccine immune responses, including consultation with
a qualified specialist, should be considered to determine whether a
protective immune response was mounted.
Fetal Risk: Based on data from animal studies,
BRIUMVI may cause fetal harm when administered to a pregnant woman.
Transient peripheral B-cell depletion and lymphocytopenia have been
reported in infants born to mothers exposed to other anti-CD20
B-cell depleting antibodies during pregnancy. A pregnancy test is
recommended in females of reproductive potential prior to each
infusion. Advise females of reproductive potential to use effective
contraception during BRIUMVI treatment and for 6 months after the
last dose.
Reduction in Immunoglobulins: As expected with
any B-cell depleting therapy, decreased immunoglobulin levels were
observed. Decrease in immunoglobulin M (IgM) was reported in 0.6%
of BRIUMVI-treated patients compared to none of the patients
treated with teriflunomide in RMS clinical trials. Monitor the
levels of quantitative serum immunoglobulins during treatment,
especially in patients with opportunistic or recurrent infections,
and after discontinuation of therapy until B-cell repletion.
Consider discontinuing BRIUMVI therapy if a patient with low
immunoglobulins develops a serious opportunistic infection or
recurrent infections, or if prolonged hypogammaglobulinemia
requires treatment with intravenous immunoglobulins.
Most Common Adverse Reactions: The most common
adverse reactions in RMS trials (incidence of at least 10%) were
infusion reactions and upper respiratory tract infections.
Physicians, pharmacists, or other healthcare professionals with
questions about BRIUMVI should visit www.briumvi.com.
The full SmPC approved in the EU for BRIUMVI can be found here
Briumvi | European Medicines Agency (europa.eu).
ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG
Therapeutics to support U.S. patients through their treatment
journey in a way that works best for them. More information about
the BRIUMVI Patient Support program can be accessed at
www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS Relapsing multiple
sclerosis (RMS) is a chronic demyelinating disease of the central
nervous system (CNS) and includes people with relapsing-remitting
multiple sclerosis (RRMS) and people with secondary progressive
multiple sclerosis (SPMS) who continue to experience relapses. RRMS
is the most common form of multiple sclerosis (MS) and is
characterized by episodes of new or worsening signs or symptoms
(relapses) followed by periods of recovery. It is estimated that
nearly 1 million people are living with MS in the United States and
approximately 85% are initially diagnosed with RRMS.1,2 The
majority of people who are diagnosed with RRMS will eventually
transition to SPMS, in which they experience steadily worsening
disability over time. Worldwide, more than 2.3 million people have
a diagnosis of MS.1
ABOUT TG THERAPEUTICSTG Therapeutics is a
fully integrated, commercial stage, biopharmaceutical company
focused on the acquisition, development, and commercialization of
novel treatments for B-cell diseases. In addition to a research
pipeline including several investigational medicines, TG has
received U.S. Food and Drug Administration (FDA) approval for
BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients
with relapsing forms of multiple sclerosis (RMS), to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, as well as approval by the
European Commission (EC) and the Medicines and Healthcare Products
Regulatory Agency (MHRA) BRIUMVI to treat adult patients with RMS
who have active disease defined by clinical or imaging features in
Europe and the United Kingdom, respectively. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary StatementThis press release contains
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release. In addition to the risk factors identified from
time to time in our reports filed with the U.S. Securities and
Exchange Commission (SEC), factors that could cause our actual
results to differ materially include the below.
Such forward-looking statements include but are not limited to
statements regarding expectations for success of our commercial
launch and availability of BRIUMVI® (ublituximab-xiiy) for
relapsing forms of multiple sclerosis (RMS); and anticipated
healthcare professional and patient acceptance and use of BRIUMVI
for the FDA-approved indications, expectations of future revenue
for BRIUMVI, expenses or profits, and our statements regarding our
potential revenue targets, operating expenses and cash
position.
Additional factors that could cause our actual results to differ
materially include the following: the Company’s ability to
establish and maintain a commercial infrastructure for BRIUMVI, and
to successfully or in the timeframe projected, market and sell
BRIUMVI; the risk that early trends in prescriptions are not
maintained or that prescriptions are not filled; the failure to
obtain and maintain payor coverage; the risk that early healthcare
professional interest in BRIUMVI will not be sustained; the risk
that momentum in sales for BRIUMVI will not build during the course
of the year; the risk that the BRIUMVI launch does not continue to
exceed expectations; the risk that our BRIUMVI revenue targets will
not be achieved; the failure to obtain and maintain requisite
regulatory approvals, including the risk that the Company fails to
satisfy post-approval regulatory requirements, the potential for
variation from the Company’s projections and estimates about the
potential market for BRIUMVI due to a number of factors, including,
further limitations that regulators may impose on the required
labeling for BRIUMVI (such as modifications, resulting from safety
signals that arise in the post-marketing setting or in the
long-term extension study from the ULTIMATE I and II clinical
trials); the Company’s ability to meet post-approval compliance
obligations (on topics including but not limited to product
quality, product distribution and supply chain, pharmacovigilance,
and sales and marketing); the Company’s reliance on third parties
for manufacturing, distribution and supply, and other support
functions for our clinical and commercial products, including
BRIUMVI, and the ability of the Company and its manufacturers and
suppliers to produce and deliver BRIUMVI to meet the market demand
for BRIUMVI; potential regulatory challenges to the Company’s plans
to seek marketing approval for the product in jurisdictions outside
of the U.S.; the uncertainties inherent in research and
development; the risk that any individual patient’s clinical
experience in the post-marketing setting, or the aggregate patient
experience in the post-marketing setting, may differ from that
demonstrated in controlled clinical trials such as ULTIMATE I and
II; the risk that subcutaneous BRIUMVI does not exhibit favorable
safety, efficacy, or pharmacokinetic properties when evaluated in
humans; the risk that the safety or tolerability profile of BRIUMVI
differs in other autoimmune disorders compared to what has been
observed in patients with MS; the risk that the Company is delayed
in initiating a clinical trial for azer-cel in non-oncology
indications; and general political, economic and business
conditions, including the risk that the ongoing COVID-19 pandemic
could have on the safety profile of BRIUMVI and any of our other
drug candidates as well as any government control measures
associated with COVID-19 that could have an adverse impact on our
research and development plans or commercialization efforts.
Further discussion about these and other risks and uncertainties
can be found in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 and in our other filings with
the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release and should not be
relied upon as representing its views as of any subsequent date. We
do not undertake to update any of these forward-looking statements
to reflect events or circumstances that occur after the date hereof
except as required by law. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements. This press release and prior releases
are available at www.tgtherapeutics.com. The information found
on our website is not incorporated by reference into this press
release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option
6
1. MS Prevalence. National Multiple
Sclerosis Society
website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence.
Accessed October 26, 2020. 2. Multiple
Sclerosis International Federation, 2013
via Datamonitor p. 236.
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