TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG
Therapeutics) today announced its financial results for the fourth
quarter and year ended December 31, 2023, along with recent company
developments.Michael S. Weiss, the Company's Chairman and Chief
Executive Officer, stated, “2023 was an exciting year of execution
for TG, which we believe has set the stage for a successful 2024.
The BRIUMVI launch exceeded our expectations, and we ended the year
with approximately $89 million in U.S. net revenue and provided a
BRIUMVI U.S. net revenue target of $220 - $260 million for 2024.
Further executing on our corporate objectives in 2023, we presented
the first data from our ENHANCE Phase 3 b trial evaluating patients
who switch from prior CD20 therapy to BRIUMVI, and recently
broadened our BRIUMVI clinical efforts to include subcutaneous
development and potential expansion beyond MS. We look forward to
sharing additional developments from these efforts throughout the
year, as well as advancing our recent pipeline addition, azer-cel,
an allogeneic CAR T into clinical development in autoimmune
disease.” Mr. Weiss continued, “We were also pleased to see our
ex-US partner, Neuraxpharm, commence the launch of BRIUMVI in
Europe this week. As the year progresses, we look forward to
providing continued updates on our launch of BRIUMVI in the U.S.
and sharing data updates throughout the year at major medical
meetings.”
2023 Highlights & Recent
DevelopmentsUnited States (U.S.) Commercialization
of BRIUMVI® (ublituximab-xiiy)
- BRIUMVI U.S. net product revenue of
$39.9 million and $88.8 million for the fourth quarter and full
year of 2023, respectively
- Approximately 3200 BRIUMVI
prescriptions received by the TG Therapeutics hub since launch,
from approximately 640 healthcare providers at approximately 400
centers
European Commercialization of BRIUMVI
- Received European Commission (EC) approval of BRIUMVI, for the
treatment of adult patients with relapsing forms of multiple
sclerosis (RMS) who have active disease defined by clinical or
imaging features
- Announced an agreement with Neuraxpharm Group (Neuraxpharm) for
the ex-U.S. commercialization of BRIUMVI in RMS
- Received approval by the Medicines and Healthcare Products
Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with
RMS with active disease defined by clinical or imaging features in
the United Kingdom (UK)
- Launched BRIUMVI in the first European country, Germany, with
our partner, Neuraxpharm
General Business
- Year-end 2023 cash position of $217.5 million
- 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
- Presented the first data from the ENHANCE Phase 3b trial
evaluating patients who switch from another CD20 antibody to
BRIUMVI
- Obtained three additional patents from the United States Patent
and Trademark Office (USPTO) for BRIUMVI, extending patent
protection through 2042
2024 Target BRIUMVI Guidance
- BRIUMVI U.S. net product revenue target of approximately $220
million to $260 million for the full year 2024
- 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 an additional autoimmune
disease 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
Financial Results for Fourth Quarter and Full Year
2023
- Product Revenue,
net: Product revenue, net includes net product sales of
BRIUMVI in the U.S. of $39.9 million and $88.8 million for the
three and twelve months ended December 31, 2023, respectively. Also
included in product revenue, net for the three and twelve months
ended December 31, 2023 is $3.2 million of BRIUMVI product revenue
for product sold to Neuraxpharm in support of that commercial
launch. Product revenue, net for the three and twelve months ended
December 31, 2022, consisted of net product sales of UKONIQ™
(umbralisib), which was withdrawn from the U.S. market in May of
2022.
- License, Milestones and
Other Revenue: License, milestone and other revenue was
approximately $0.8 million and $141.7 million for the three and
twelve months ended December 31, 2023, respectively, compared to
less than $0.1 million and $0.2 million for the three and twelve
months ended December 31, 2022, respectively. License, milestone,
and other revenue for the twelve months ended December 31, 2023, is
primarily related to the $140.0 million one-time payment received
from Neuraxpharm in July 2023 upon execution of the agreement for
the ex-U.S. commercialization of BRIUMVI in RMS.
- R&D Expenses:
Total research and development (R&D) expense was $17.4 million
and $76.2 million for the three and twelve months ended December
31, 2023, respectively, compared to $29.6 million and $125.4
million for the three and twelve months ended December 31, 2022,
respectively. The decrease in R&D expense is primarily
attributable to reduced clinical trial related expenses, license
milestones, manufacturing expense, and lower fees paid to
consultants and outside service providers during the twelve months
ended December 31, 2023, over the comparable period in 2022. Prior
to the approval of BRIUMVI, manufacturing costs pertaining to
BRIUMVI were expensed to R&D expense in the period incurred,
and following approval are reflected in inventory.
- SG&A Expenses:
Total selling, general and administrative (SG&A) expense was
$31.2 million and $122.7 million for the three and twelve months
ended December 31, 2023, respectively, and $22.5 million and $70.0
million for the three and twelve months ended December 31, 2022,
respectively. The increase was primarily due to non-cash
compensation SG&A expenses incurred, and other costs, including
personnel and consultants, associated with the commercialization of
BRIUMVI during the three and twelve months ended December 31,
2023.
- Net Loss/Net
Income: Net loss was $14.4 million for the three months
ended December 31, 2023 and net income was $12.7 million for the
twelve months ended December 31, 2023, compared to net loss of
$53.0 million and $198.3 million for the three and twelve months
ended December 31, 2022, respectively.
- Cash Position and Financial
Guidance: Cash, cash equivalents and investment securities
were $217.5 million as of December 31, 2023. We anticipate that our
cash, cash equivalents and investment securities as of December 31,
2023, combined with projected revenues from BRIUMVI, will be
sufficient to fund the Company’s planned operations into cash flow
positivity based on the current operating plan.
CONFERENCE CALL INFORMATIONThe Company will
host a conference call today, February 28, 2024, at 8:30 AM ET, to
discuss the Company’s financial results from the fourth quarter and
full year ended December 31, 2023.
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 US 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 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 or December 31,
2022 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.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations:Email:
media@tgtxinc.comTelephone: 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 December
31, |
|
|
|
Twelve months ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
Product revenue, net |
$ |
43,137 |
|
$ |
42 |
|
|
$ |
92,005 |
|
$ |
2,633 |
|
License, milestone and other
revenue |
|
834 |
|
|
38 |
|
|
|
141,657 |
|
|
152 |
|
Total revenue |
|
43,971 |
|
|
80 |
|
|
|
233,662 |
|
|
2,785 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue |
|
7,855 |
|
|
3 |
|
|
|
14,131 |
|
|
265 |
|
Research and development: |
|
|
|
|
|
Noncash compensation |
|
2,848 |
|
|
5,753 |
|
|
|
13,010 |
|
|
13,224 |
|
Other research and development |
|
14,601 |
|
|
23,882 |
|
|
|
63,182 |
|
|
112,128 |
|
Total research and
development |
|
17,449 |
|
|
29,635 |
|
|
|
76,192 |
|
|
125,352 |
|
|
|
|
|
|
|
Selling, general and
administrative: |
|
|
|
|
|
Noncash compensation |
|
6,537 |
|
|
5,298 |
|
|
|
24,923 |
|
|
5,961 |
|
Other selling, general and administrative |
|
24,615 |
|
|
17,206 |
|
|
|
97,783 |
|
|
64,046 |
|
Total selling, general and
administrative |
|
31,152 |
|
|
22,504 |
|
|
|
122,706 |
|
|
70,007 |
|
|
|
|
|
|
|
Total costs and expenses |
|
56,456 |
|
|
52,142 |
|
|
|
213,029 |
|
|
195,624 |
|
|
|
|
|
|
|
Operating income (loss) |
|
(12,485 |
) |
|
(52,062 |
) |
|
|
20,633 |
|
|
(192,839 |
) |
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
Interest expense |
|
2,432 |
|
|
2,862 |
|
|
|
12,615 |
|
|
10,191 |
|
Other income |
|
(891 |
) |
|
(1,930 |
) |
|
|
(5,044 |
) |
|
(4,695 |
) |
Total other expense, net |
|
1,541 |
|
|
932 |
|
|
|
7,571 |
|
|
5,496 |
|
|
|
|
|
|
|
Net income (loss) before
taxes |
$ |
(14,026 |
) |
$ |
(52,994 |
) |
|
$ |
13,062 |
|
$ |
(198,335 |
) |
Income taxes |
|
390 |
|
|
- |
|
|
|
390 |
|
|
- |
|
Net income (loss) |
$ |
(14,416 |
) |
$ |
(52,994 |
) |
|
$ |
12,672 |
|
$ |
(198,335 |
) |
|
|
|
|
|
|
Net income (loss) per common
share: |
|
|
|
|
|
Basic |
$ |
(0.10 |
) |
$ |
(0.39 |
) |
|
$ |
0.09 |
|
$ |
(1.46 |
) |
Diluted |
$ |
(0.09 |
) |
$ |
(0.39 |
) |
|
$ |
0.09 |
|
$ |
(1.46 |
) |
Weighted average common shares
outstanding: |
|
|
|
|
|
Basic |
|
143,092,594 |
|
|
137,108,759 |
|
|
|
141,955,112 |
|
|
135,411,258 |
|
Diluted |
|
156,091,786 |
|
|
137,108,759 |
|
|
|
148,508,465 |
|
|
135,411,258 |
|
Condensed Balance
Sheet Information (in thousands): |
|
|
|
December 31, 2023(Unaudited) |
December 31, 2022* |
Cash, cash equivalents and
investment securities |
217,508 |
|
174,082 |
|
Total assets |
329,587 |
|
193,572 |
|
Accumulated deficit |
(1,514,361 |
) |
(1,527,033 |
) |
Total equity |
160,502 |
|
58,587 |
|
* Condensed from audited financial statements
TG Therapeutics (NASDAQ:TGTX)
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TG Therapeutics (NASDAQ:TGTX)
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