TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial
results for the second quarter ended June 30, 2023, along with
recent company developments, and a business outlook for 2023.
Michael S. Weiss, the Company's Chairman and Chief Executive
Officer, stated, “We are pleased to report our second quarter 2023
results, representing our first full quarter of BRIUMVI sales,
which exceeded our expectations. It’s been gratifying to see
BRIUMVI adopted by such a broad range of MS centers and providers
so early into our launch and we are humbled when we hear positive
feedback on patients’ experience with BRIUMVI. With its
glycoengineering for efficient B-cell depletion, lowest reported
annualized relapse rates of any CD20 agent in RMS Phase 3 trials
and rapid and reliable 1-hour infusion, a number of providers have
already made BRIUMVI their CD20 of choice in RMS. I believe our
quarterly performance showcases the unwavering dedication of our
team, and the potential of BRIUMVI, to improve the lives of
patients with MS.” Mr. Weiss continued, “With an ex-U.S. partner in
place, we can continue to focus our now enhanced resources on our
U.S. commercial launch. I believe our team has executed well on our
early launch plan and we are looking forward to building on this
momentum as we move forward with the next phase of our launch
strategy.”
Recent Highlights &
DevelopmentsUnited States (U.S.) Commercialization
of BRIUMVI® (ublituximab-xiiy)
- Received U.S. Food and Drug Administration (FDA) approval
of BRIUMVI, for the treatment of relapsing forms of multiple
sclerosis (RMS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease, and commercially launched BRIUMVI in the U.S. on January
26, 2023, making it available for patients and physicians.
- Achieved $16 million in BRIUMVI net sales for the second
quarter 2023, total net product revenue of $23.8 million since
launch.
- Secured payor coverage policies for approximately 80% of
covered lives across the U.S.
- Over 800 BRIUMVI prescriptions in the second quarter of 2023,
marking over 1200 prescriptions since launch, from more than 340
healthcare providers at more than 225 centers.
- Received a permanent J-Code (J2329) for BRIUMVI from the U.S.
Centers for Medicare & Medicaid Services (CMS), which became
effective July 1, 2023.
European Commercialization of BRIUMVI
- Received European Commission (EC) approval of BRIUMVI, for the
treatment of adult patients with RMS who have active disease
defined by clinical or imaging features, on June 1, 2023.
- Announced an agreement with Neuraxpharm for the ex-U.S.
commercialization of BRIUMVI in RMS today, August 1, 2023.
Agreement terms include a total deal size of $645 million with over
$150 million in upfront and near-term milestones, tiered
double-digit royalties up to 30% and an option to buy-back all
rights under the commercialization agreement for a period of two
years in the event of an acquisition of TG.
General Business
- Strengthened our cash position with current pro-forma cash of
approximately $285 million.
- Presented additional data, including new analyses, from the
ULTIMATE I and II Phase 3 trials at the 2023 Consortium of Multiple
Sclerosis Centers (CMSC) annual meeting.
Key Objectives for 2023
- Continue to build upon the U.S. commercial launch of BRIUMVI in
RMS
- Continue to increase access to BRIUMVI
- Continue to generate and present additional clinical trial data
for BRIUMVI in RMS
Financial Results for the Three and Six Months Ended
June 30, 2023
- Product Revenue, Net: Product revenue, net was
approximately $16.0 million and $23.8 million for the three and six
months ended June 30, 2023, compared to $0.6 million and $2.5
million for the three and six months ended June 30, 2022. Product
revenue, net for the three and six months ended June 30, 2023,
consisted of net product sales of BRIUMVI in the U.S., which was
commercially launched in late January 2023. Product revenue, net
for the three and six months ended June 30, 2022, consisted of net
product sales of UKONIQ™ (umbralisib), which was withdrawn from the
U.S. market in May of 2022.
- R&D Expenses: Total research and
development (R&D) expense was $28.1 million and $44.0 million
for the three and six months ended June 30, 2023, compared to $26.9
million and $74.9 million for the three and six months ended June
30, 2022. The decrease in R&D expense during the six months
ended June 30, 2023 was primarily attributable to reduced
manufacturing expense and clinical trial related expenses, offset
by an increase in license milestone expense of approximately $6.0
million during the six months ended June 30, 2023. 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 $30.7 million and $58.8
million for the three and six months ended June 30, 2023, compared
to $12.6 million and $33.2 million for the three and six months
ended June 30, 2022. The increase was primarily due to non-cash
compensation SG&A expenses incurred, and other costs, including
personnel, associated with the commercialization of BRIUMVI during
the three and six months ended June 30, 2023.
- Net Loss: Net loss was $47.6 million and $86.8
million for the three and six months ended June 30, 2023, compared
to $40.5 million and $109.5 million for the three and six months
ended June 30, 2022. Excluding non-cash compensation, the net loss
for the three and six months ended June 30, 2023, was approximately
$35.1 million and $67.5 million, compared to a net loss of $41.5
million and $108.4 million for the three and six months ended June
30, 2022.
- Cash Position and Financial
Guidance: Cash, cash equivalents and investment securities
were $144.9 million as of June 30, 2023. We anticipate that our
cash, cash equivalents and investment securities as of June 30,
2023, combined with the upfront payment of $140.0 million received
as part of our ex-U.S. commercialization agreement and projected
revenues associated with the sale of BRIUMVI in the U.S. and
ex-U.S., will be sufficient to fund our planned operations for the
foreseeable future.
CONFERENCE CALL INFORMATIONThe Company will
host a conference call today, August 1, 2023, at 8:30 AM ET, to
discuss the Company’s financial results from the second quarter,
ended June 30, 2023, the Neuraxpharm ex-U.S. commercialization
agreement, and provide a business outlook for the remainder of
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 for the treatment of adults with relapsing
forms of multiple sclerosis (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 European
Commission (EC) approval for BRIUMVI to treat adult patients with
RMS who have active disease defined by clinical or imaging
features. For more information, visit www.tgtherapeutics.com,
and follow us on Twitter @TGTherapeutics and on
LinkedIn.
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 our
commercial launch and availability of BRIUMVI® (ublituximab-xiiy)
for relapsing forms of multiple sclerosis (RMS); anticipated
healthcare professional and patient acceptance and use of BRIUMVI
for the FDA-approved indications, and statements regarding the
results of the ULTIMATE I & II Phase 3 studies and BRIUMVI as a
potential treatment for RMS.
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, 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 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; 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. 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, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
Product revenue, net |
|
16,036 |
|
$556 |
|
|
|
23,801 |
|
|
2,534 |
|
License revenue |
|
38 |
|
|
38 |
|
|
|
76 |
|
|
76 |
|
Total revenue |
|
16,074 |
|
|
594 |
|
|
|
23,877 |
|
|
2,610 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of product revenue |
|
1,911 |
|
|
23 |
|
|
|
2,768 |
|
|
260 |
|
Research and development: |
|
|
|
|
|
Noncash compensation |
|
5,664 |
|
|
2,328 |
|
|
|
7,247 |
|
|
4,223 |
|
Other research and development |
|
22,458 |
|
|
24,546 |
|
|
|
36,744 |
|
|
70,693 |
|
Total research and
development |
|
28,122 |
|
|
26,874 |
|
|
|
43,991 |
|
|
74,916 |
|
|
|
|
|
|
|
Selling, general and
administrative: |
|
|
|
|
|
Noncash compensation |
|
6,877 |
|
|
(3,304 |
) |
|
|
12,117 |
|
|
(3,077 |
) |
Other selling, general and administrative |
|
23,838 |
|
|
15,942 |
|
|
|
46,666 |
|
|
36,324 |
|
Total selling, general and
administrative |
|
30,715 |
|
|
12,638 |
|
|
|
58,783 |
|
|
33,247 |
|
|
|
|
|
|
|
Total operating expenses |
|
60,748 |
|
|
39,535 |
|
|
|
105,542 |
|
|
108,423 |
|
|
|
|
|
|
|
Operating loss |
|
(44,674 |
) |
|
(38,941 |
) |
|
|
(81,665 |
) |
|
(105,813 |
) |
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
Interest expense |
|
3,627 |
|
|
3,017 |
|
|
|
6,471 |
|
|
5,681 |
|
Other income |
|
(691 |
) |
|
(1,448 |
) |
|
|
(1,295 |
) |
|
(1,971 |
) |
Total other expense (income),
net |
|
2,936 |
|
|
1,569 |
|
|
|
5,176 |
|
|
3,710 |
|
|
|
|
|
|
|
Consolidated net loss |
$(47,610 |
) |
$(40,510 |
) |
|
$(86,841 |
) |
$(109,523 |
) |
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
Basic and diluted |
$(0.34 |
) |
$(0.30 |
) |
|
$(0.62 |
) |
$(0.81 |
) |
Weighted average shares used
in computing basic and diluted net loss per common share |
|
141,503,738 |
|
|
137,779,904 |
|
|
|
140,911,295 |
|
|
134,591,250 |
|
Condensed Balance
Sheet Information (in thousands): |
|
|
|
June 30, 2023(Unaudited) |
|
December 31, 2022* |
|
Cash, cash equivalents and
investment securities |
144,905 |
|
174,082 |
|
Total assets |
220,854 |
|
193,572 |
|
Accumulated deficit |
(1,613,875 |
) |
(1,527,033 |
) |
Total equity |
40,453 |
|
58,587 |
|
* Condensed from audited financial statements
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