TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG
Therapeutics) today announced its financial results for the first
quarter of 2024, along with recent company developments.
Michael S. Weiss, the Company's Chairman and Chief Executive
Officer, stated, “We were extremely pleased with the strong sales
of just over $50 million in BRIUMVI U.S. net revenue for the first
quarter of 2024, which was ahead of our guidance. We believe this
strong momentum will continue to build throughout 2024 and are
pleased to update our yearly guidance to $270 to $290 million in
BRIUMVI U.S. net revenue in 2024.” Mr. Weiss continued, “We are
also pleased to be making strides towards our clinical goals for
the year which include enhancing the convenient dosing of IV
BRIUMVI, developing a subcutaneous form of BRIUMVI, moving BRIUMVI
into additional indications beyond MS, and advancing our recent
pipeline addition, azer-cel, an allogeneic CAR T, into clinical
development.”
Recent Highlights & Developments
United States (U.S.) Commercialization of
BRIUMVI® (ublituximab-xiiy)
- BRIUMVI U.S. net product revenue of
$50.5 million for the first quarter of 2024, representing >25%
quarter over quarter growth
- Approximately 4,450 BRIUMVI new
patient prescriptions received by the TG Therapeutics hub since
launch, including more than 1,250 in the first quarter of 2024,
from approximately 800 healthcare providers at approximately 450
centers
- Awarded a national contract with
the Department of Veterans Affairs (VA) for BRIUMVI to be the
preferred agent listed on the VA National Formulary for anti-CD20
antibody indications for patients with relapsing forms of multiple
sclerosis
European Commercialization of BRIUMVI
- Launched BRIUMVI in the first European country, Germany, with
our partner, Neuraxpharm Group (Neuraxpharm)
General Business
- Presented updated data from the ENHANCE Phase 3b trial
evaluating patients who switch from another CD20 antibody to
BRIUMVI at the Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) annual forum
- Obtained three additional patents from the United States Patent
and Trademark Office (USPTO) for BRIUMVI, extending patent
protection through 2042
- Entered into a global license agreement with Precision
BioSciences, Inc. (Precision) for the development and
commercialization of Precision’s allogeneic CD19 CAR T therapy
program, azercabtagene zapreleucel (azer-cel), for the treatment of
autoimmune disorders and all other non-oncology indications
2024 Updated Target U.S. BRIUMVI Guidance
- Q2 2024 target BRIUMVI U.S. net product revenue of
approximately $65 million
- Updating BRIUMVI U.S. net product revenue target to
approximately $270 million to $290 million for the full year 2024
(prior guidance of $220 to $260 million for full year 2024)
2024 Development Pipeline Anticipated
Milestones
- Commence clinical development of subcutaneous BRIUMVI
- Commence a clinical trial evaluating BRIUMVI in an additional
autoimmune disease outside of multiple sclerosis (MS)
- Commence a clinical trial evaluating azer-cel in autoimmune
disease
- Present data from the ENHANCE Phase 3b CD20 switch trial at
multiple conferences throughout the year
Financial Results for First Quarter 2024
- Product
Revenue, Net: Product revenue, net was approximately $50.5
million for the three months ended March 31, 2024, compared to $7.8
million for the three months ended March 31, 2023. Product revenue,
net for both the three months ended March 31, 2024 and March 31,
2023, consisted of net product sales of BRIUMVI in the United
States.
- License,
milestone, royalty and other revenue: License, milestone,
royalty and other revenue was approximately $13.0 million and less
than $0.1 million for the three months ended March 31, 2024 and
March 31, 2023, respectively. License, milestone, royalty and other
revenue for the three months ended March 31, 2024 is predominantly
comprised of a $12.5 milestone payment under the Neuraxpharm
Commercialization Agreement for the first key market commercial
launch of BRIUMVI in the European Union.
- R&D
Expenses: Total research and development (R&D) expense
was $32.7 million for the three months ended March 31, 2024,
compared to $15.9 million for the three months ended March 31,
2023. The increase in R&D expense during the three months ended
March 31, 2024, was primarily attributable to license and milestone
expense of $8.8 million related to the license agreement with
Precision, as well as additional manufacturing and development
costs incurred in connection with our ublituximab subcutaneous
development work during the period.
- SG&A
Expenses: Total selling, general and administrative
(SG&A) expense was $34.6 million for the three months ended
March 31, 2024, compared to $28.1 million during the three months
ended March 31, 2023. The increase was primarily due to the
scale-up of the BRIUMVI commercial launch, including personnel and
consultants, during the three months ended March 31, 2024.
- Net
Loss: Net loss was $10.7 million for the three months
ended March 31, 2024, compared to a net loss of $39.2 million for
the three months ended March 31, 2023.
- Cash
Position and Financial Guidance: Cash, cash equivalents
and investment securities were $209.8 million as of March 31, 2024.
We anticipate that our cash, cash equivalents and investment
securities as of March 31, 2024, combined with the projected
revenues from BRIUMVI, will be sufficient to fund our planned
operations to cash flow positivity based on our current operating
plan.
CONFERENCE CALL INFORMATIONThe Company will
host a conference call today, May 1, 2024, at 8:30 AM ET, to
discuss the Company’s financial results from the first quarter,
ended March 31, 2024.
To participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics. A live audio webcast will be
available on the Events page, located within the Investors &
Media section, of the Company's website at
http://ir.tgtherapeutics.com/events. An audio recording of the
conference call will also be available for a period of 30 days
after the call.
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 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 in the U.S. for the treatment of adults
with RMS, including clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease and in the EU and UK for the treatment of adult patients
with RMS with active disease defined by clinical or imaging
features.
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, JC virus 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 Summary of Product Characteristics approved in the
European Union (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 Therapeutics has
received approval from the U.S. Food and Drug Administration (FDA)
for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients
with relapsing forms of multiple sclerosis, including 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) for 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 X
(formerly 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 the timing and success of the
commercial launch and availability of BRIUMVI® (ublituximab-xiiy)
for RMS in the United States and Europe; anticipated healthcare
professional (HCP) and patient acceptance and use of BRIUMVI for
the approved indications; expectations of future revenue for
BRIUMVI, expenses or profits; expectations for our pipeline
products; and statements regarding the results of the ENHANCE or
ULTIMATE I & II Phase 3 studies.
Additional factors that could cause our actual results to differ
materially include the following: the Company’s ability to maintain
and continue to maintain a commercial infrastructure for BRIUMVI,
and to successfully or in the timeframe projected, launch, 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 HCP
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 current or future 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 the Company does not achieve its 2024
development pipeline anticipated milestones in the timeframe
projected or at all, including commencing development of
subcutaneous BRIUMVI, commencing a trial evaluating BRIUMVI in an
autoimmune disease outside of MS, or commencing a trial evaluating
azer-cel; and general political, economic and business conditions.
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, 2023 and in our other filings with
the SEC.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
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.com |
|
Telephone: 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.
TG Therapeutics,
Inc.Selected Condensed Consolidated Financial
DataStatements of Operations Information (in
thousands, except share and per share amounts;
unaudited):
|
Three months ended March 31, |
|
|
2024 |
|
2023 |
|
Revenue |
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
50,488 |
|
|
$ |
7,765 |
|
|
License, milestone, royalty and other revenue |
|
12,986 |
|
|
|
38 |
|
|
Total revenue |
|
63,474 |
|
|
|
7,803 |
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of revenue |
|
5,441 |
|
|
|
857 |
|
|
Research and development: |
|
|
|
|
|
|
|
|
Noncash compensation |
|
2,452 |
|
|
|
1,584 |
|
|
Other research and development |
|
30,270 |
|
|
|
14,286 |
|
|
Total research and development |
|
32,722 |
|
|
|
15,870 |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative: |
|
|
|
|
|
|
|
|
Noncash compensation |
|
6,887 |
|
|
|
5,240 |
|
|
Other selling, general and administrative |
|
27,694 |
|
|
|
22,828 |
|
|
Total selling, general and administrative |
|
34,581 |
|
|
|
28,068 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
72,744 |
|
|
|
44,795 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(9,270 |
) |
|
|
(36,992 |
) |
|
|
|
|
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
|
|
|
Interest expense |
|
2,288 |
|
|
|
2,844 |
|
|
Other income |
|
(880 |
) |
|
|
(604 |
) |
|
Total other expense, net |
|
1,408 |
|
|
|
2,240 |
|
|
|
|
|
|
|
|
|
|
|
Net loss before taxes |
|
(10,678 |
) |
|
|
(39,232 |
) |
|
Income Taxes |
|
29 |
|
|
|
- |
|
|
Net Loss |
$ |
(10,707 |
) |
|
$ |
(39,232 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per common share: |
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.28 |
) |
|
Weighted average shares used
in computing basic and diluted net loss per common share |
|
146,209,213 |
|
|
|
140,312,269 |
|
|
|
Condensed Balance Sheet Information (in
thousands):
|
March 31, 2024 (Unaudited) |
|
December 31, 2023* |
|
Cash, cash equivalents and investment securities |
209,785 |
|
|
217,508 |
|
|
Total assets |
373,323 |
|
|
329,587 |
|
|
Accumulated deficit |
1,525,068 |
|
|
(1,514,361 |
) |
|
Total equity |
160,109 |
|
|
160,502 |
|
|
|
|
|
|
|
|
|
* Condensed from audited financial statements |
|
|
|
|
|
|
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