TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial
results for the third quarter ended September 30, 2023, along with
recent company developments.
Michael S. Weiss, the Company's Chairman and Chief
Executive Officer, stated, “The team has executed very well in the
third quarter, making significant progress on our corporate goals
and continuing to build a solid foundation for the BRIUMVI launch.
We showed strong net quarterly revenue of approximately $166
million, including an upfront milestone payment from our ex-U.S.
partner, Neuraxpharm, as well as $25.1 million in BRIUMVI net sales
in the U.S., which again exceeded our expectations.” Mr. Weiss
continued, “The adoption of BRIUMVI from both healthcare providers
and centers continues to grow, which I believe positions us to
close out the year on a positive note and I am excited for 2024 and
for the future of BRIUMVI and TG.”
Recent Highlights & Developments
General Business
- Total net quarterly revenue of $165.8 million, with a current
cash position of $229.2 million
- Presented the first data from the ENHANCE Phase 3b trial
evaluating patients with relapsing forms of multiple sclerosis
(RMS) who switch from an IV anti-CD20 therapy to BRIUMVI, as well
as additional exploratory data from the ULTIMATE I and II Phase 3
trials at the 2023 European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) annual meeting.
United States (U.S.) Commercialization of
BRIUMVI® (ublituximab-xiiy)
- Achieved $25.1 million in BRIUMVI net sales for the third
quarter 2023; total net product revenue of approximately $48.9
million since launch.
- Secured payor coverage policies for approximately 95% of
covered lives across the U.S.
- Over 900 BRIUMVI prescriptions in the third quarter of 2023,
marking approximately 2,200 prescriptions since launch, from more
than 500 healthcare providers at more than 250 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 on August 1, 2023.
- 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).
Financial Results for the Three and Nine Months Ended
September 30, 2023
- Product Revenue, Net: Product revenue, net was
approximately $25.1 million and $48.9 million for the three and
nine months ended September 30, 2023, compared to $0.1 million and
$2.6 million for the three and nine months ended September 30,
2022. Product revenue, net for the three and nine months ended
September 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 nine months ended September
30, 2022, consisted of net product sales of UKONIQ™ (umbralisib),
which was withdrawn from the U.S. market in May of 2022.
- License revenue: License revenue was
approximately $140.0 million and $140.1 million for the three and
nine months ended September 30, 2023, compared to less than $0.1
million and $0.1 million for the three and nine months ended
September 30, 2022. License revenue for the three and nine months
ended September 30, 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 $14.8 million and $58.7 million
for the three and nine months ended September 30, 2023, compared to
$20.8 million and $95.7 million for the three and nine months ended
September 30, 2022. The decrease in R&D expense during the nine
months ended September 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 nine months ended September 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 $32.8 million and $91.6
million for the three and nine months ended September 30, 2023,
compared to $14.3 million and $47.5 million for the three and nine
months ended September 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 nine months ended September 30,
2023.
- Net Income (Loss): Net income was $113.9
million and $27.1 million for the three and nine months ended
September 30, 2023, compared to a net loss of $35.8 million and
$145.3 million for the three and nine months ended September 30,
2022.
- Cash Position and Financial Guidance: Cash,
cash equivalents and investment securities were $229.2 million as
of September 30, 2023. We anticipate that our cash, cash
equivalents and investment securities as of September 30, 2023,
combined with the projected revenues from BRIUMVI, will be
sufficient to fund our planned operations into cash flow positivity
based on the current operating plan.
|
CONFERENCE CALL INFORMATIONThe Company will
host a conference call today, November 1, 2023, at 8:30 AM ET, to
discuss the Company’s financial results from the third quarter,
ended September 30, 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, expectations of future revenue
for BRIUMVI, expenses or profits; and statements regarding the
results of the ENHANCE or 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 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; 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 September
30, |
|
Nine months ended September 30, |
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
Product revenue, net |
$ |
25,068 |
|
$ |
56 |
|
|
$ |
48,868 |
|
$ |
2,591 |
|
License, milestone and other
revenue |
|
140,747 |
|
|
38 |
|
|
|
140,823 |
|
|
114 |
|
Total revenue |
|
165,815 |
|
|
94 |
|
|
|
189,691 |
|
|
2,705 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue |
|
3,509 |
|
|
2 |
|
|
|
6,277 |
|
|
262 |
|
Research and development: |
|
|
|
|
|
Noncash compensation |
|
2,915 |
|
|
3,249 |
|
|
|
10,162 |
|
|
7,471 |
|
Other research and development |
|
11,838 |
|
|
17,552 |
|
|
|
48,581 |
|
|
88,246 |
|
Total research and
development |
|
14,753 |
|
|
20,801 |
|
|
|
58,743 |
|
|
95,717 |
|
|
|
|
|
|
|
Selling, general and
administrative: |
|
|
|
|
|
Noncash compensation |
|
6,269 |
|
|
3,740 |
|
|
|
18,386 |
|
|
663 |
|
Other selling, general and administrative |
|
26,500 |
|
|
10,514 |
|
|
|
73,167 |
|
|
46,840 |
|
Total selling, general and
administrative |
|
32,769 |
|
|
14,254 |
|
|
|
91,553 |
|
|
47,503 |
|
|
|
|
|
|
|
Total costs and expenses |
|
51,031 |
|
|
35,057 |
|
|
|
156,573 |
|
|
143,482 |
|
|
|
|
|
|
|
Operating income (loss) |
|
114,784 |
|
|
(34,963 |
) |
|
|
33,118 |
|
|
(140,777 |
) |
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
Interest expense |
|
3,713 |
|
|
1,648 |
|
|
|
10,184 |
|
|
7,329 |
|
Other income |
|
(2,859 |
) |
|
(793 |
) |
|
|
(4,154 |
) |
|
(2,765 |
) |
Total other expense, net |
|
854 |
|
|
855 |
|
|
|
6,030 |
|
|
4,564 |
|
|
|
|
|
|
|
Net income (loss) |
$ |
113,930 |
|
$ |
(35,818 |
) |
|
$ |
27,088 |
|
$ |
(145,341 |
) |
|
|
|
|
|
|
Net income (loss) per common
share: |
|
|
|
|
|
Basic |
$ |
0.80 |
|
$ |
(0.26 |
) |
|
$ |
0.19 |
|
$ |
(1.08 |
) |
Diluted |
$ |
0.73 |
|
$ |
(0.26 |
) |
|
$ |
0.19 |
|
$ |
(1.08 |
) |
Weighted average common shares
outstanding: |
|
|
|
|
|
Basic |
|
142,871,227 |
|
|
135,327,035 |
|
|
|
141,571,785 |
|
|
134,839,207 |
|
Diluted |
|
155,871,749 |
|
|
135,327,035 |
|
|
|
145,952,913 |
|
|
134,839,207 |
|
Condensed
Balance Sheet Information (in thousands): |
|
September 30,
2023(Unaudited) |
December 31, 2022* |
Cash, cash equivalents and investment securities |
229,159 |
|
174,082 |
|
Total assets |
331,067 |
|
193,572 |
|
Accumulated deficit |
(1,499,945 |
) |
(1,527,033 |
) |
Total equity |
164,769 |
|
58,587 |
|
* Condensed from audited financial
statements
TG Therapeutics (NASDAQ:TGTX)
過去 株価チャート
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TG Therapeutics (NASDAQ:TGTX)
過去 株価チャート
から 9 2023 まで 9 2024