TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG
Therapeutics) today announced its financial results for the second
quarter of 2024, along with recent company developments and
provided an update on 2024 revenue guidance.Michael S. Weiss, the
Company’s Chairman and Chief Executive Officer stated, “We are
pleased to report another quarter of outperformance across all
aspects of our business. From a financial standpoint, our second
quarter U.S. BRIUMVI net revenues exceeded expectations, leading us
to raise our full year guidance. On the R&D side, we also had
an exciting quarter with the first patients now treated with
subcutaneous ublituximab in a newly launched Phase 1 study and
clearance of our IND for azer-cel, our allogeneic “off-the-shelf”
CD19 CAR-T, for patients with progressive MS.” Mr. Weiss continued,
“We are also excited to announce our new $250 million credit
facility with HealthCare Royalty and Blue Owl Capital that enables
us to accelerate the initiation of a share repurchase program and
pay down our current debt, while preserving our current cash to
continue building our commercial infrastructure, ramping up our
marketing efforts, and investing in our R&D programs. We look
forward to continuing the positive momentum into the second half of
2024.”
Recent Highlights &
DevelopmentsUnited States (U.S.) Commercialization
of BRIUMVI® (ublituximab-xiiy)
- BRIUMVI U.S. net product revenue of $72.6 million for the
second quarter of 2024, representing >350% growth over the
second quarter of 2023
- Approximately 5,850 BRIUMVI new patient prescriptions received
by the TG Therapeutics hub since launch, from approximately 950
healthcare providers at approximately 525 centers, including more
than 1,400 prescriptions received in the second quarter of
2024
- Awarded a national contract with the Department of Veterans
Affairs (VA) for BRIUMVI to be the preferred anti-CD20 agent listed
on the VA National Formulary for patients with relapsing forms of
multiple sclerosis (RMS)
Development Updates & General Business
- Initiated a phase 1 clinical trial evaluating subcutaneous
ublituximab in RMS, with the first patients now dosed
- Received clearance by the U.S. Food and Drug Administration
(FDA) of an Investigational New Drug (IND) application for azer-cel
in progressive forms of multiple sclerosis (MS)
- Obtained three additional patents from the United States Patent
and Trademark Office (USPTO) for BRIUMVI, extending patent
protection through 2042
Corporate Finance Updates
- Established a new 5-year, $250 million credit facility with
HealthCare Royalty and Blue Owl Capital, set to mature in 2029,
primarily to repay $107 million in outstanding debt and accrued
interest, which was set to mature in multiple tranches from
mid-2025 to January 2026, and to fund the buyback of up to $100
million of currently outstanding shares of the Company’s common
stock. The remainder will be available for working capital
purposes, providing the Company with additional operational
flexibility.
2024 Updated Target U.S. BRIUMVI Guidance
- Updating BRIUMVI U.S. net product revenue target to
approximately $290 to $300 million for the full year 2024 (prior
guidance of $270 to $290 million for full year 2024)
Remaining 2024 Development Pipeline Anticipated
Milestones
- Study BRIUMVI in an additional autoimmune disease outside of
MS
- Commence a clinical trial evaluating azer-cel in autoimmune
diseases, starting with progressive MS
- Present additional data from the ENHANCE Phase 3b CD20 switch
trial
Financial Results for Second Quarter 2024
- Product Revenue, net: Product revenue, net was
approximately $72.6 million and $123.1 million for the three and
six months ended June 30, 2024, respectively, compared to $16.0
million and $23.8 million for the three and six months ended June
30, 2023, respectively. Product revenue, net for both the three and
six months ended June 30, 2024 and 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
$0.9 million and $13.9 million for the three and six months ended
June 30, 2024, respectively, compared to less than $0.1 million for
both the three and six months ended June 30, 2023, respectively.
License, milestone, royalty and other revenue for the six months
ended June 30, 2024 is predominantly comprised of a $12.5 million
milestone payment under the Neuraxpharm Commercialization Agreement
for the first key market commercial launch of BRIUMVI in the
European Union (EU) which occurred in the first quarter of
2024.
- R&D Expenses: Total research and
development (R&D) expense was approximately $17.6 million and
$50.3 million for the three and six months ended June 30, 2024,
respectively, compared to $28.1 million and $44.0 million for the
three and six months ended June 30, 2023, respectively. The
decrease in R&D expense during the three months ended June 30,
2024 was primarily attributable to reduced clinical trial related
expense and license milestones incurred during the period ended
June 30, 2024. The increase in R&D expense during the six
months ended June 30, 2024 was primarily attributable to license
and milestone expense related to the license agreement with
Precision BioSciences, Inc., 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 approximately $38.8 million
and $73.4 million for the three and six months ended June 30, 2024,
respectively, compared to $30.7 million and $58.8 million for the
three and six months ended June 30, 2023, respectively. The
increase in both periods was primarily due to the scale-up of the
BRIUMVI commercial launch, including personnel.
- Net Income (Loss): Net income (loss) was $6.9
million and $(3.8) million for the three and six months ended June
30, 2024, respectively, compared to a net loss of $(47.6) million
and $(86.8) million for the three and six months ended June 30,
2023, respectively.
- Cash Position and Financial Guidance: Cash,
cash equivalents and investment securities were $217.3 million as
of June 30, 2024, which excludes any increase in cash associated
with the new $250 million credit facility. We anticipate that our
cash, cash equivalents and investment securities as of June 30,
2024, combined with the projected revenues from BRIUMVI, will be
sufficient to fund our business based on our current operating
plan.
CONFERENCE CALL INFORMATIONThe Company will
host a conference call today, August 6, 2024 at 8:30 AM ET to
discuss the Company’s financial results from the second quarter
ended June 30, 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
ongoing commercialization 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; our ability to initiate and execute the
proposed share repurchase program; and 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, market and sell
BRIUMVI; the risk that trends in prescriptions are not maintained
or that prescriptions are not filled; the failure to obtain and
maintain payor coverage; the risk that 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
commercialization of BRIUMVI 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 the development of subcutaneous
BRIUMVI, commencing a trial evaluating BRIUMVI in an autoimmune
disease outside of MS, or commencing a trial evaluating azer-cel;
our ability to initiate and execute the proposed share repurchase
program; 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.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.
TG Therapeutics, Inc.Selected Condensed
Consolidated Financial Data |
Statements of Operations Information (in thousands, except
share and per share amounts; unaudited): |
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
Product revenue, net |
|
72,596 |
|
|
16,036 |
|
|
|
123,084 |
|
|
23,801 |
|
License, milestone, royalty
and other revenue |
|
870 |
|
|
38 |
|
|
|
13,855 |
|
|
76 |
|
Total revenue |
|
73,466 |
|
|
16,074 |
|
|
|
136,939 |
|
|
23,877 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue |
|
8,304 |
|
|
1,911 |
|
|
|
13,745 |
|
|
2,768 |
|
Research and development: |
|
|
|
|
|
Noncash compensation |
|
2,520 |
|
|
5,664 |
|
|
|
4,972 |
|
|
7,247 |
|
Other research and development |
|
15,036 |
|
|
22,458 |
|
|
|
45,306 |
|
|
36,744 |
|
Total research and
development |
|
17,556 |
|
|
28,122 |
|
|
|
50,278 |
|
|
43,991 |
|
|
|
|
|
|
|
Selling, general and
administrative: |
|
|
|
|
|
Noncash compensation |
|
6,962 |
|
|
6,877 |
|
|
|
13,848 |
|
|
12,117 |
|
Other selling, general and administrative |
|
31,828 |
|
|
23,838 |
|
|
|
59,522 |
|
|
46,666 |
|
Total selling, general and
administrative |
|
38,790 |
|
|
30,715 |
|
|
|
73,370 |
|
|
58,783 |
|
|
|
|
|
|
|
Total costs and expenses |
|
64,650 |
|
|
60,748 |
|
|
|
137,393 |
|
|
105,542 |
|
|
|
|
|
|
|
Operating income (loss) |
|
8,816 |
|
|
(44,674 |
) |
|
|
(454 |
) |
|
(81,665 |
) |
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
Interest expense |
|
3,977 |
|
|
3,627 |
|
|
|
6,265 |
|
|
6,471 |
|
Other income |
|
(1,712 |
) |
|
(691 |
) |
|
|
(2,592 |
) |
|
(1,295 |
) |
Total other expense , net |
|
2,265 |
|
|
2,936 |
|
|
|
3,673 |
|
|
5,176 |
|
|
|
|
|
|
|
Net income (loss) before
taxes |
$ |
6,551 |
|
$ |
(47,610 |
) |
|
$ |
(4,127 |
) |
$ |
(86,841 |
) |
Income tax benefit |
|
328 |
|
|
- |
|
|
|
299 |
|
|
- |
|
Net Income (loss) |
$ |
6,879 |
|
$ |
(47,610 |
) |
|
$ |
(3,828 |
) |
$ |
(86,841 |
) |
|
|
|
|
|
|
Net income (loss) per common
share: |
|
|
|
|
|
Basic |
$ |
0.05 |
|
$ |
(0.34 |
) |
|
$ |
(0.03 |
) |
$ |
(0.62 |
) |
Diluted |
$ |
0.04 |
|
$ |
(0.34 |
) |
|
$ |
(0.03 |
) |
$ |
(0.62 |
) |
|
|
|
|
|
|
Weighted average shares of
common stock outstanding |
|
|
|
|
|
Basic |
|
144,727,482 |
|
|
141,503,738 |
|
|
|
145,464,255 |
|
|
140,911,295 |
|
Diluted |
|
159,423,571 |
|
|
141,503,738 |
|
|
|
145,464,255 |
|
|
140,911,295 |
|
Condensed Balance Sheet Information (in
thousands):
|
June 30, 2024(Unaudited) |
December 31, 2023* |
Cash, cash equivalents and investment securities |
217,252 |
217,508 |
Total assets |
401,207 |
329,587 |
Total equity |
177,568 |
160,502 |
* Condensed from audited financial statements
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