TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial
results for the first quarter ending March 31, 2021 and recent
company developments, along with a business outlook for 2021.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "2021 has been an incredibly impactful
year, kicking off with our first approval coming ahead of schedule
for UKONIQ to treat both relapsed or refractory Marginal Zone
Lymphoma and Follicular Lymphoma. That was followed by the
completion of a BLA submission for ublituximab in combination with
UKONIQ (U2) to treat patients with CLL, and the full presentation
of positive results from the ULTIMATE I & II Phase 3 trials in
relapsing forms of MS. As a fully integrated commercial
organization we are pleased with our progress thus far with the
UKONIQ launch and we look forward to continuing to build our
commercial infrastructure to support the potential approval and
commercialization of U2 in CLL and ublituximab in RMS.”
2021 Highlights & Recent Developments
UKONIQTM (umbralisib)
in Relapsed or Refractory Marginal Zone Lymphoma & Follicular
Lymphoma
- Received accelerated approval from the U.S. Food and Drug
Administration (FDA) on February 5, 2021 for UKONIQ to treat adult
patients with relapsed or refractory marginal zone lymphoma (MZL)
who have received at least one prior anti-CD20 based regimen and
adult patients with relapsed or refractory follicular lymphoma (FL)
who have received at least three prior lines of systemic
therapy.
- Launch efforts underway across the U.S. UKONIQ has payor
coverage for 85-90% of Medicare and commercial lives and is
included in the National Comprehensive Cancer Network (NCCN)
Clinical Practice Guidelines for MZL and FL, consistent with the
FDA-approved indications.
- Published results from the UKONIQ monotherapy cohorts of the
UNITY-NHL Phase 2b trial in patients with relapsed or refractory
indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical
Oncology.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic
Leukemia
- Completed a rolling submission of a Biologics License
Application (BLA) to the FDA requesting approval of U2, as a
treatment for patients with chronic lymphocytic leukemia (CLL),
including both previously untreated and relapsed/refractory
patients, based on the positive results from the UNITY-CLL Phase 3
trial.
- Completed enrollment in the ULTRA-V
Phase 2 trial, and launched the ULTRA-V Phase 3 randomized trial
evaluating the triple combination of U2 plus venetoclax in patients
with treatment naïve and relapsed or refractory CLL.
Ublituximab in Multiple Sclerosis
- Presented positive results from the ULTIMATE I & II Phase 3
trials at the American Academy of Neurology 2021 Annual Meeting.
Both trials met their primary endpoint with ublituximab treatment
demonstrating a statistically significant reduction in annualized
relapse rate (ARR) over a 96-week period compared to teriflunomide
in patients with relapsing forms of multiple sclerosis (RMS).
TG-1701 in B-cell Malignancies
- Updated data from TG-1701, our BTK
inhibitor, as a monotherapy and in combination with U2 in patients
with B-cell malignancies has been accepted for presentation at the
American Society of Clinical Oncology (ASCO) annual meeting being
held in June 2021.
Remaining Key Objectives for 2021
- Focus on the commercialization of UKONIQ in relapsed/refractory
MZL and FL and expand commercialization capabilities in preparation
for a potential launch of U2 for CLL and ublituximab in MS
- Submit a BLA for ublituximab for the treatment of patients with
RMS in Q3 2021, based on positive results from the ULTIMATE I &
II Phase 3 trials
- Receive notification from the FDA that the BLA for U2 in CLL
has been accepted for filing and work closely with the Agency on
its review of the application
- Enroll into the newly launched ULTRA-V Phase 3 trial evaluating
the triple combination of U2 plus venetoclax
- Continue to advance our early pipeline candidates including
TG-1501 (cosibelimab), TG-1701 and TG-1801
Financial Results for the Three Months Ended March 31,
2021
- Product Revenue,
net: Product revenue, net was approximately $0.8 million
for the three months ended March 31, 2021, compared to zero during
the comparable period in 2020. Net product revenues represent U.S.
sales from our sole commercial product, UKONIQ, which received
accelerated approval from the FDA on February 5, 2021, with launch
later in the month.
- R&D Expenses:
Total research and development (R&D) expense was $63.1 million
for the three months ended March 31, 2021, compared to $36.0
million for the three months ended March 31, 2020. The increase was
due primarily to licensing milestone fees of approximately $14.0
million incurred during the first quarter of 2021 and an increase
of approximately $5.5 million in non-cash compensation R&D
expenses over the comparable quarter in 2020.
- SG&A Expenses:
Total selling, general and administrative (SG&A) expense was
$26.8 million for the three months ended March 31, 2021 and $14.3
million for the three months ended March 31, 2020. The increase was
due primarily to increased personnel and other selling, general and
administrative costs associated with preparations for, and now
execution of, the commercial launch of UKONIQ. We expect our
selling, general and administrative expenses to increase for the
remainder of 2021 in preparation for the potential launch of
ublituximab as part of the U2 combination for CLL and as a
monotherapy in MS.
- Net Loss: Net loss
was $90.6 million for the three months ended March 31, 2021
compared to $51.1 million for the three months ended March 31,
2020. Excluding non-cash compensation, the net loss for the three
months ended March 31, 2021 was approximately $74.0 million,
compared to a net loss of $40.0 million for the three months ended
March 31, 2020.
- Cash Position and Financial
Guidance: Cash, cash equivalents and investment securities
were $523.8 million as of March 31, 2021, which the Company
believes will be sufficient to fund the Company's planned
operations into 2023.
CONFERENCE CALL INFORMATIONThe Company will
host a conference call today, May 10, 2021, at 8:30 AM ET, to
discuss the Company’s first quarter ended March 31, 2021 financial
results and provide a business outlook for the remainder of
2021.
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 TG THERAPEUTICS, INC.TG
Therapeutics is a fully-integrated, commercial stage
biopharmaceutical company focused on the acquisition, development
and commercialization of novel treatments for B-cell malignancies
and autoimmune diseases. In addition to an active research pipeline
including five investigational medicines across these therapeutic
areas, TG has received accelerated approval from
the U.S. FDA for UKONIQ™ (umbralisib), for the
treatment of adult patients with relapsed/refractory marginal zone
lymphoma who have received at least one prior anti-CD20-based
regimen and relapsed/refractory follicular lymphoma who have
received at least three prior lines of systemic therapies.
Currently, the Company has two programs in Phase 3 development for
the treatment of patients with relapsing forms of multiple
sclerosis (RMS) and patients with chronic lymphocytic leukemia
(CLL) and several investigational medicines in Phase 1 clinical
development. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and Linkedin.UKONIQ™ is a
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. Such forward looking
statements include but are not limited to statements regarding the
Company’s plans, goals, strategies, timelines, anticipated
milestones, and expectations for our current or future
approved drugs and drug candidates, including the continued U.S.
approval and commercialization of UKONIQTM (umbralisib); plans and
timelines for marketing applications and review expectations for
ublituximab in combination with UKONIQ in CLL or ublituximab
monotherapy in RMS and, if approved, commercializing the
combination regimen in CLL or ublituximab monotherapy in RMS; the
initiation of clinical trials or the results of ongoing and planned
clinical trials; the potential benefits of any of the
Company’s current or future approved drugs or drug candidates
in treating patients; and financial guidance regarding the period
in which we will have sufficient capital resources to fund our
operations.
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 Securities and
Exchange Commission, factors that could cause our actual results to
differ materially include the following: our ability to establish,
maintain and enhance our commercial infrastructure, and to
successfully market and sell UKONIQ or future products, if
approved; our ability to meet post-approval regulatory requirements
for UKONIQ and future products, including submission of sufficient
data from a confirmatory clinical study, and post-approval
compliance obligations (on topics including but not limited to
product quality, product distribution and supply chain,
pharmacovigilance, and sales and marketing); the potential for
variation from the Company’s projections and estimates about the
potential market for UKONIQ or the Company’s product candidates due
to a number of factors, including for example, limitations that
regulators may impose on the required labeling for the product; our
ability to reach certain regulatory milestones at all or within the
timelines projected; our ability to submit a BLA for ublituximab in
RMS within the timeline projected; our ability to obtain, or to
obtain within the timeline projected, marketing authorization for
our product candidates, including ublituximab in combination with
UKONIQ in CLL and ublituximab monotherapy in RMS; our ability to
successfully complete analyses of our clinical study results and
present data within the timeframes projected; the risk that
the interim, top-line and preliminary data from our clinical trials
that we announce or publish may change, or the perceived product
profile may be impacted, as more patient data or additional
endpoints are analyzed; the risk that preclinical and clinical
results for the Company’s drug candidates may not support
further development of such drug candidates; actions of regulatory
agencies, which may affect the initiation, timing and progress of
clinical trials; the Company’s reliance on third parties for
manufacturing, distribution and supply, and a range of other
support functions for its clinical and commercial products,
including UKONIQ; the uncertainties inherent in research and
development; the risk that the ongoing COVID-19 pandemic and
associated government control measures have an adverse impact on
our research and development plans or commercialization efforts;
the accuracy of our estimates regarding expenses, future revenue,
capital requirements and needs for additional financing; our
financial performance; and the sufficiency of our existing capital
resources to fund our future operating expenses. 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, 2020 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
TG Therapeutics,
Inc.Selected Condensed Consolidated Financial
Data
Statements of Operations Information (in thousands,
except share and per share amounts;
unaudited):
|
|
|
Three Months Ended |
|
|
|
March 31, 2021 |
|
March 31, 2020 |
Revenue |
|
|
|
|
Product revenue,
net |
|
$ |
755 |
|
|
$ |
- |
|
License
revenue |
|
|
38 |
|
|
|
38 |
|
Total revenue |
|
|
793 |
|
|
|
38 |
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
Cost of product
revenue |
|
|
139 |
|
|
|
- |
|
Research and
development |
|
|
|
|
|
Non-cash compensation |
|
|
7,511 |
|
|
|
1,979 |
|
|
Other research and
development |
|
|
55,583 |
|
|
|
34,043 |
|
Total research and
development |
|
|
63,094 |
|
|
|
36,022 |
|
|
|
|
|
|
|
Selling, general
and administrative |
|
|
|
|
|
Non-cash compensation |
|
|
9,107 |
|
|
|
9,089 |
|
|
Other selling, general and
administrative |
|
|
17,655 |
|
|
|
5,172 |
|
Total selling,
general and administrative |
|
|
26,762 |
|
|
|
14,261 |
|
|
|
|
|
|
|
Total operating
expenses |
|
|
89,995 |
|
|
|
50,283 |
|
|
|
|
|
|
|
Operating
loss |
|
|
(89,202) |
|
|
|
(50,245) |
|
|
|
|
|
|
|
Other (income)
expense: |
|
|
|
|
|
Interest expense |
|
|
1,898 |
|
|
|
1,201 |
|
|
Other income |
|
|
(472) |
|
|
|
(330) |
|
Total other
(income) expense |
|
|
1,426 |
|
|
|
871 |
|
|
|
|
|
|
|
Consolidated net
loss |
|
$ |
(90,628) |
|
|
$ |
(51,116) |
|
|
|
|
|
|
|
Net loss per
common share: |
|
|
|
|
|
Basic and diluted |
|
$ |
(0.69) |
|
|
$ |
(0.48) |
|
|
|
|
|
|
|
Weighted average
shares of common stock outstanding: |
|
|
|
Basic and diluted |
|
|
131,898,626 |
|
|
|
105,461,892 |
|
|
|
|
|
|
|
|
|
|
|
Condensed Balance Sheet Information (in
thousands):
|
March 31, 2021(Unaudited) |
December 31, 2020* |
Cash, cash equivalents and investment securities |
$ |
523,848 |
|
$ |
605,426 |
|
Total assets |
|
548,699 |
|
|
625,642 |
|
Accumulated deficit |
|
(1,071,225) |
|
|
(980,597) |
|
Total equity |
|
445,285 |
|
|
519,350 |
|
* Condensed from audited financial statements
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