TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial
results for the second quarter ending June 30, 2021 and recent
company developments, along with a business outlook for the
remainder 2021.
Michael S. Weiss, the Company's Chairman and Chief Executive
Officer, stated, "We are pleased with the progress made throughout
the second quarter, including our ongoing launch of UKONIQ in
relapsed or refractory MZL and FL, FDA’s acceptance of our BLA/sNDA
for the combination of ublituximab and UKONIQ (U2) to treat CLL and
SLL, and the continued advancement of our clinical programs. We
have built a strong commercialization infrastructure to launch
UKONIQ and have received positive feedback from healthcare
providers on their experiences with the product and with the TG
team. We believe this solid commercialization foundation will
support, if approved, the launch of U2 in CLL and ublituximab in
relapsing forms of multiple sclerosis.”
Mr. Weiss continued, “We look forward to an exciting second half
of 2021, during which we plan to submit a BLA for ublituximab to
treat patients with relapsing forms of multiple sclerosis, continue
executing on the launch of UKONIQ in MZL and FL, and continue
preparations for potential commercialization of U2 in CLL and
ublituximab in RMS.”
2021 Highlights & Recent Developments
UKONIQ® (umbralisib) in Relapsed or
Refractory Marginal Zone Lymphoma & Follicular
Lymphoma
- Launched UKONIQ in the U.S. 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.
- Generated $2.3M in total net UKONIQ revenue from launch through
the end of Q2 2021, approximately 4 months.
- Achieved broad U.S. payor coverage for more than 90% of
Medicare and commercial lives and inclusion in the National
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines
for MZL and FL.
Ublituximab plus UKONIQ (U2) in Chronic Lymphocytic
Leukemia
- Received FDA acceptance of a Biologics License Application
(BLA) for ublituximab and a supplemental New Drug Application
(sNDA) for UKONIQ, both submissions requesting approval of U2 as a
treatment for patients with chronic lymphocytic leukemia (CLL) and
small lymphocytic lymphoma (SLL). These applications were primarily
based on results from the UNITY-CLL Phase 3 trial, which included
both treatment-naïve and relapsed or refractory (R/R) patients. The
FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of
March 25, 2022 for both applications.
- 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 R/R CLL.
Ublituximab in Multiple Sclerosis
- Presented positive results from the ULTIMATE I and II Phase 3
trials at the 2021 American Academy of Neurology (AAN) annual
meeting and the 7th Congress of the European Academy of Neurology
(EAN). 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
- Presented updated data from
TG-1701, our BTK inhibitor, as a monotherapy and in combination
with U2 in patients with B-cell malignancies at the 2021 American
Society of Clinical Oncology (ASCO) annual meeting, the 2021
European Hematology Association (EHA) virtual congress and the 16th
International Congress on Malignant Lymphoma (ICML).
Remaining Key Objectives for 2021 and Early
2022
- Focus on the commercialization of
UKONIQ in R/R MZL and FL and expand commercialization capabilities
in preparation for a potential launch of U2 in CLL and ublituximab
in RMS
- Submit a BLA for ublituximab for
the treatment of patients with RMS in Q3 2021, based on positive
results from the ULTIMATE I and II Phase 3 trials
- Obtain approval for U2 in CLL and
SLL by the PDUFA goal date of March 25, 2022
- 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 and Six Months Ended
June 30, 2021
- Product Revenue,
net: Product revenue, net was approximately $1.5 million
and $2.3 million for the three and six months ended June 30, 2021,
compared to zero during the comparable periods 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.
- R&D Expenses:
Total research and development (R&D) expense was $44.9 million
and $108.0 million for the three and six months ended June 30,
2021, compared to $36.5 million and $72.5 million for the three and
six months ended June 30, 2020. The increase was due primarily to
licensing milestone fees of approximately $4.0 million and $18.0
million incurred during the three and six months ended June 30,
2021, and an increase in non-cash compensation R&D expense over
the comparable periods in 2020.
- SG&A Expenses:
Total selling, general and administrative (SG&A) expense was
$34.0 million and $60.8 million for the three and six months ended
June 30, 2021, and $14.4 million and $28.7 million for the three
and six months ended June 30, 2020. The increase was due primarily
to increased personnel and other selling, general and
administrative costs associated with execution of the launch of
UKONIQ and planning for the potential launches of U2 in CLL and
ublituximab in RMS. We expect our selling, general and
administrative expenses to increase for the remainder of 2021 as we
continue to prepare for those potential 2022 launches.
- Net Loss: Net loss
was $78.5 million and $169.1 million for the three and six months
ended June 30, 2021, compared to $52.9 million and $104.0 million
for the three and six months ended June 30, 2020. Excluding
non-cash compensation, the net loss for the three and six months
ended June 30, 2021 was approximately $62.2 million and $136.2
million, compared to a net loss of $45.5 million and $85.6 million
for the three and six months ended June 30, 2020.
- Cash Position and Financial
Guidance: Cash, cash equivalents and investment securities
were $456.2 million as of June 30, 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, August 2, 2021, at 8:30 AM ET, to
discuss the Company’s second quarter ended June 30, 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 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. 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; 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. 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 from those expressed
or implied by any forward-looking statements contained in this
press release 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, including 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 or for the
indications sought, marketing authorization for our product
candidates, including ublituximab in combination with UKONIQ in
CLL/SLL, inclusive of treatment-naïve and R/R patients, 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 regulatory authorities disagree with the
conclusions we have reached or data we have publicly disclosed and
we are unable to obtain approval for, or successfully
commercialize, our product candidates; 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.com |
|
Telephone: 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 June 30, |
|
Six months ended June 30, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
Revenue |
|
|
|
|
|
Product revenue, net |
$ |
1,507 |
$ |
-- |
|
$ |
2,262 |
$ |
-- |
License revenue |
|
38 |
|
38 |
|
|
76 |
|
76 |
Total revenue |
|
1,545 |
|
38 |
|
|
2,338 |
|
76 |
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of product revenue |
|
148 |
|
-- |
|
|
288 |
|
-- |
Research and development: |
|
|
|
|
|
Noncash compensation |
|
7,016 |
|
1,553 |
|
|
14,527 |
|
3,532 |
Other research and development |
|
37,855 |
|
34,896 |
|
|
93,438 |
|
68,939 |
Total research and
development |
|
44,871 |
|
36,449 |
|
|
107,965 |
|
72,471 |
|
|
|
|
|
|
Selling, general and
administrative: |
|
|
|
|
|
Noncash compensation |
|
9,288 |
|
5,817 |
|
|
18,395 |
|
14,906 |
Other selling, general and administrative |
|
24,729 |
|
8,617 |
|
|
42,384 |
|
13,789 |
Total selling, general and
administrative |
|
34,017 |
|
14,434 |
|
|
60,779 |
|
28,695 |
|
|
|
|
|
|
Total operating expenses |
|
79,036 |
|
50,883 |
|
|
169,032 |
|
101,166 |
|
|
|
|
|
|
Operating loss |
|
(77,492) |
|
(50,845) |
|
|
(166,694) |
|
(101,090) |
|
|
|
|
|
|
Other expense (income): |
|
|
|
|
|
Interest expense |
|
1,623 |
|
2,228 |
|
|
3,521 |
|
3,429 |
Other income |
|
(618) |
|
(189) |
|
|
(1,090) |
|
(519) |
Total other expense (income),
net |
|
1,005 |
|
2,039 |
|
|
2,431 |
|
2,910 |
|
|
|
|
|
|
Consolidated net loss |
$ |
(78,497) |
$ |
(52,884) |
|
$ |
(169,125) |
$ |
(104,000) |
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
Basic and diluted |
$ |
(0.59) |
$ |
(0.47) |
|
$ |
(1.28) |
$ |
(0.95) |
|
|
|
|
|
|
Weighted average shares of
common stock outstanding: |
|
|
|
|
|
Basic and diluted |
|
132,072,996 |
|
112,353,414 |
|
|
131,986,293 |
|
108,926,690 |
Condensed Balance Sheet Information (in
thousands):
|
June 30, 2021 |
December 31, 2020* |
|
(Unaudited) |
|
Cash, cash equivalents and investment securities |
456,216 |
605,426 |
Total assets |
481,400 |
625,642 |
Accumulated deficit |
(1,149,722) |
(980,597) |
Total equity |
383,130 |
519,350 |
* |
Condensed from
audited financial statements |
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