TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2020 Financial Results
March 02 2021 - 6:00AM
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial
results for the fourth quarter and year ended December 31, 2020 and
recent company developments, along with a business outlook for
2021.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer, stated, "2020 was a year of data and regulatory
execution for us as we delivered results from our UNITY-NHL study
that led to the approval of UKONIQ in relapsed/refractory MZL and
FL and from UNITY-CLL that will be used to support the current
rolling BLA submission for ublituximab in combination with
umbralisib for patients with CLL. We also announced the top
line results from our ULTIMATE MS Phase 3 trials that will be used
to support a BLA submission for ublituximab in MS. These
successful outcomes were made possible by the hard work of everyone
at TG over many years and has positioned us for an exciting 2021.”
Mr. Weiss continued, “With the UKONIQ launch underway, we are
excited to keep the momentum going and expect this year to complete
our BLA submission for U2 in CLL, present final results from the
ULTIMATE trials and then submit a BLA for ublituximab in MS, and
continue to advance our triple therapy combination trials and our
early pipeline.”
2020 Highlights & Recent Developments
- FDA Accelerated Approval of
UKONIQ™ (umbralisib) in Relapsed/Refractory MZL & FL
- Received accelerated approval from
the U.S. Food and Drug Administration (FDA) for UKONIQ for the
treatment of 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.
- Presented umbralisib monotherapy
results from the UNITY-NHL Phase 2b trial in patients with relapsed
or refractory MZL, FL and small lymphocytic lymphoma (SLL) at the
62nd American Society of Hematology (ASH) annual meeting.
- Received orphan drug designation
(ODD) from the FDA for umbralisib for the treatment of FL.
- Chronic Lymphocytic
Leukemia
- Presented results from the
UNITY-CLL Phase 3 trial at the 62nd ASH annual meeting showing the
trial met its primary endpoint of ublituximab and umbralisib (U2)
significantly improving progression-free survival (PFS) over
obinutuzumab plus chlorambucil.
- Initiated 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.
- Granted Fast Track Designation by
the FDA for the combination of U2 for the treatment of adult
patients with CLL.
- Presented data from the triple
combination of U2 plus venetoclax in patients with relapsed or
refractory (R/R) CLL and data from the combination of U2 plus
TG-1701, the Company’s BTK inhibitor, in patients with R/R CLL or
B-cell lymphoma, at the 62nd ASH annual meeting.
- Published final results from the
Phase 3 GENUINE trial evaluating ublituximab in combination with
ibrutinib, in patients with relapsed or refractory high-risk CLL,
in The Lancet Haematology.
- Multiple Sclerosis
- Announced that the Phase 3 ULTIMATE
I & II 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).
- Published results from the
multicenter Phase 2 trial evaluating ublituximab in RMS, in the
Multiple Sclerosis Journal.
- Strengthened Cash
Position
- Ended the year with more than $600
million in cash, cash equivalents and investment securities.
Key Objectives for 2021
- Continue the commercialization of
UKONIQ in relapsed/refractory MZL and FL and expand
commercialization capabilities in preparation for a potential
launch of ublituximab
- Present results from the ULTIMATE I
& II Phase 3 trials evaluating ublituximab in RMS and prepare a
BLA submission
- Complete the rolling BLA submission
of ublituximab, in combination with umbralisib, for the treatment
of patients with CLL
- Complete enrollment in the ULTRA-V
Phase 2b trial and begin a 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 Fourth Quarter and Full Year
2020
- R&D Expenses:
Other research and development (R&D) expense (not including
non-cash compensation) was $37.1 million and $151.9 million for the
three and twelve months ended December 31, 2020, respectively,
compared to $29.5 million and $148.3 million for the three and
twelve months ended December 31, 2019, respectively. The increase
in R&D expense during the year ended December 31, 2020 is
primarily attributable to an increase in licensing milestones as
well as clinical trial and personnel expense of approximately $34.4
million, partially offset by a decrease in manufacturing expense of
approximately $30.6 million. We expect our other research and
development costs to remain at consistent levels throughout
2021.
- G&A Expenses:
Other general and administrative (G&A) expense (not including
non-cash compensation) was $16.2 million and $41.5 million for the
three and twelve months ended December 31, 2020, respectively, as
compared to $2.9 million and $9.5 million for the three and twelve
months ended December 31, 2019, respectively. The increase during
the three and twelve months ended December 31, 2020 was due
primarily to commercialization costs, including personnel, incurred
in preparation for the U.S. launch of UKONIQ. We expect our other
general and administrative expenses to increase modestly during
2021 in preparation for our launch of ublituximab.
- Net Loss: Net loss
was $88.2 million and $279.4 million for the three and twelve
months ended December 31, 2020, respectively, compared to a net
loss of $39.6 million and $172.9 million for the three and twelve
months ended December 31, 2019, respectively. The net loss for the
twelve months ended December 31, 2020 included approximately $21.0
million of one-time milestone expenses related to our license
agreements. Excluding non-cash compensation, the net loss for the
three and twelve months ended December 31, 2020 was approximately
$54.7 million and $199.1 million, respectively, compared to a net
loss of $34.0 million and $161.5 million for the three and twelve
months ended December 31, 2019, respectively.
- Cash Position and Financial
Guidance: Cash, cash equivalents and investment securities
were $605.4 million as of December 31, 2020, 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, March 2, 2021, at 8:30 AM ET, to
discuss the Company’s fourth quarter and year-end 2020 financial
results and provide a business outlook for 2021.
In order 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 replay at
www.tgtherapeutics.com, 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 UKONIQ™ (umbralisib); plans
and timelines for marketing applications and review expectations
for ublituximab in combination with umbralisib and, if approved,
commercializing the combination regimen; the initiation of clinical
trials or the results of ongoing and planned clinical trials;
and the potential benefits of any of the
Company’s current or future approved drugs or drug candidates
in treating patients.
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
and maintain a commercial infrastructure, and to successfully
launch, market and sell UKONIQ or future products, if approved; our
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
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 complete regulatory
submissions within the timelines projected, including completion of
the rolling BLA submission for ublituximab in combination with
umbralisib in CLL; our ability to obtain, or to obtain within the
timeline projected, marketing authorization for our product
candidates, and to maintain marketing authorization for UKONIQ,
including the risk we may fail to satisfy post-approval regulatory
requirements, such as the submission of sufficient data from a
confirmatory clinical study; our ability to successfully complete
analyses of our clinical study results and present data within the
timeframes projected, including the risk that we do not present
data from the ULTIMATE I & II trials as currently
planned; 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 (including efficacy and
safety) 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.comTelephone: 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 December 31, |
|
|
|
Year ended December 31, |
|
|
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
License revenue |
|
$ |
38 |
|
$ |
38 |
|
|
$ |
152 |
|
$ |
152 |
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
Research and development: |
|
|
|
|
|
|
Noncash stock expense associated with in-licensing agreements |
|
|
-- |
|
|
-- |
|
|
|
-- |
|
|
100 |
|
Noncash compensation |
|
|
5,811 |
|
|
1,488 |
|
|
|
13,962 |
|
|
5,811 |
|
Other research and development |
|
|
37,149 |
|
|
29,454 |
|
|
|
151,934 |
|
|
148,269 |
|
Total research and
development |
|
|
42,960 |
|
|
30,942 |
|
|
|
165,896 |
|
|
154,180 |
|
|
|
|
|
|
|
|
General and
administrative: |
|
|
|
|
|
|
Noncash compensation |
|
|
27,709 |
|
|
4,133 |
|
|
|
66,327 |
|
|
5,523 |
|
Other general and administrative |
|
|
16,150 |
|
|
2,923 |
|
|
|
41,523 |
|
|
9,504 |
|
Total general and
administrative |
|
|
43,859 |
|
|
7,056 |
|
|
|
107,850 |
|
|
15,027 |
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
86,819 |
|
|
37,998 |
|
|
|
273,746 |
|
|
169,207 |
|
|
|
|
|
|
|
|
Operating loss |
|
|
(86,781 |
) |
|
(37,960 |
) |
|
|
(273,594 |
) |
|
(169,055 |
) |
|
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
|
Interest expense |
|
|
1,291 |
|
|
1,899 |
|
|
|
6,329 |
|
|
5,287 |
|
Other expense (income) |
|
|
145 |
|
|
(288 |
) |
|
|
(542 |
) |
|
(1,471 |
) |
Total other expense, net |
|
|
1,436 |
|
|
1,611 |
|
|
|
5,787 |
|
|
3,816 |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(88,217 |
) |
$ |
(39,571 |
) |
|
$ |
(279,381 |
) |
$ |
(172,871 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
|
$ |
(0.71 |
) |
$ |
(0.44 |
) |
|
$ |
(2.42 |
) |
$ |
(1.96 |
) |
|
|
|
|
|
|
|
Weighted average shares used
in computing basic and diluted net loss per common share |
|
|
124,096,131 |
|
|
95,659,624 |
|
|
|
115,333,693 |
|
|
88,368,844 |
|
Condensed Balance Sheet Information (in
thousands):
|
December 31, 2020(Unaudited) |
December 31, 2019* |
Cash, cash equivalents and investment securities |
$ |
605,426 |
|
|
$ |
140,435 |
|
Total assets |
|
625,642 |
|
|
|
163,014 |
|
Accumulated deficit |
|
(980,597 |
) |
|
|
(701,216 |
) |
Total equity |
|
519,350 |
|
|
|
38,615 |
|
* Condensed from audited financial statements
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