TLC Reports Third Quarter 2020 Financial Results and Provides Business Update
28 Outubro 2020 - 5:50AM
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty
pharmaceutical company developing novel nanomedicines to target
areas of unmet medical need, today announced financial results for
the third quarter ending September 30, 2020, and provided a
business update.
“As we journey toward the end of 2020, we are
excited about the imminent enrollment completion in our EXCELLENCE
trial of TLC599 for osteoarthritis pain,” commented George Yeh,
President of TLC. “Moreover, we have made tremendous progress in
the advancement of our anti-COVID-19 program, TLC19, which has
evolved from an incubated idea to being tested in humans in an
extremely short amount of time. I would also like to extend a very
warm welcome back to Mr. Tom Bliss, who will serve as our new CBO
and lead TLC in its commercialization and licensing efforts.”
Clinical Pipeline Update and Upcoming
Milestones
- First
patient enrollment in Phase I
clinical
trial of
inhalable
anti-COVID-19
program. Following approval from
Australia’s Human Research Ethics Committee (HREC) and
Taiwan’s Food and Drug Administration (TFDA), TLC has promptly
enrolled the first patient in the Phase I randomized,
vehicle-controlled, blinded study, which will evaluate the safety,
tolerability, and pharmacokinetics of single ascending doses of
inhaled TLC19 (inhalable liposomal hydroxychloroquine) in healthy
volunteers. Data from this trial will serve as a basis for
subsequent clinical trials in patients with COVID-19.
-
~80% enrollment complete in
EXCELLENCE, the Phase III,
multi-center, randomized, double-blind, placebo- and active
comparator- controlled pivotal study evaluating the efficacy and
safety of both a single and a repeated dose of TLC599 for
symptomatic knee osteoarthritis. EXCELLENCE remains on-track
to complete enrollment of all 500 patients before the end of 2020,
with topline data expected in late 2021.
Corporate Highlights
-
Appointment of Thomas H. Bliss, Jr., MBA, as Chief Business
Officer. Mr. Bliss brings with him ample experience in
licensing and business development functions from Amgen, Baxter and
Johnson & Johnson, and will take the lead in TLC’s global
corporate and business development efforts, with a key focus on the
United States.
-
Acceptance of Marketing Authorization Application
(MAA) for Ampholipad™ in China.
The Center for Drug Evaluation (CDE) of the China National Medical
Products Administration (NMPA) has accepted TLC’s MAA for
Ampholipad™, TLC’s complex generic of Gilead’s AmBisome®
(amphotericin B liposome for injection) for the treatment of
systemic fungal infections. AmBisome is currently not available in
mainland China, creating a rare opportunity for Ampholipad to
become available before the brand drug.
-
Presented at several
global conferences. The
management team of TLC presented the latest company updates at
Baird’s 2020 Virtual Global Healthcare Conference, HC Wainwright
22nd Annual Global Investment Conference, Cantor Virtual Global
Healthcare Conference and Oppenheimer Fall Healthcare Life Sciences
& MedTech Summit.
-
Expanded global intellectual property protection to 243
patents, with 156 patents granted and 87 applications
worldwide as of September 30, 2020.
Financial Results
Operating revenue for the third quarter of
fiscal 2020 was NT$66.1 million (US$2.3 million), a 250.9% increase
compared to NT$18.8 million (US$0.6 million) in the third quarter
of fiscal 2019. Operating expenses for the third quarter of fiscal
2020 was NT$309.7 million (US$10.7 million), a 56.3% increase
compared to NT$198.1 million (US$6.4 million) in the third quarter
of fiscal 2019. Net loss for the third quarter of fiscal 2020 was
NT$233.7 million (US$8.1 million), compared to a loss of NT$178.4
million (US$5.7 million) in the third quarter of 2019, or a net
loss of NT$2.78 (US$0.10) per share for the third quarter of fiscal
2020, compared to a net loss of NT$2.80 (US$0.09) per share for the
third quarter of fiscal 2019.
The Company’s cash and cash equivalents were
NT$1,015.1 million (US$35.1 million) as of September 30, 2020,
compared to NT$1,023.9 million (US$34.2 million) as of December 31,
2019.
Financial Summary
Selected Consolidated Balance Sheet Data
|
|
December 31, 2019 |
|
|
September 30, 2020 |
|
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
Cash and cash equivalents and time deposit |
|
$ |
1,023,874 |
|
|
$ |
34,232 |
|
|
$ |
1,015,093 |
|
|
$ |
35,064 |
|
Total current assets |
|
|
1,095,614 |
|
|
|
36,631 |
|
|
|
1,158,516 |
|
|
|
40,018 |
|
Total assets |
|
|
1,385,978 |
|
|
|
46,339 |
|
|
|
1,486,068 |
|
|
|
51,332 |
|
Total current liabilities |
|
|
556,697 |
|
|
|
18,612 |
|
|
|
285,411 |
|
|
|
9,859 |
|
Long-term borrowings |
|
|
55,508 |
|
|
|
1,856 |
|
|
|
401,710 |
|
|
|
13,876 |
|
Total liabilities |
|
|
664,068 |
|
|
|
22,202 |
|
|
|
763,627 |
|
|
|
26,377 |
|
Total equity |
|
|
721,910 |
|
|
|
24,137 |
|
|
|
722,441 |
|
|
|
24,955 |
|
Selected Consolidated Statements of Operations Data
|
|
Three-month periods ended September 30, |
|
|
Nine-month periods ended September 30, |
|
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
Operating revenue |
|
$ |
18,837 |
|
|
$ |
607 |
|
|
$ |
66,095 |
|
|
$ |
2,283 |
|
|
$ |
197,194 |
|
|
$ |
6,351 |
|
|
$ |
89,845 |
|
|
$ |
3,104 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
(40,226 |
) |
|
|
(1,296 |
) |
|
|
(38,166 |
) |
|
|
(1,318 |
) |
|
|
(119,129 |
) |
|
|
(3,837 |
) |
|
|
(110,533 |
) |
|
|
(3,818 |
) |
Research and development expenses |
|
|
(157,901 |
) |
|
|
(5,085 |
) |
|
|
(271,541 |
) |
|
|
(9,380 |
) |
|
|
(611,273 |
) |
|
|
(19,687 |
) |
|
|
(692,200 |
) |
|
|
(23,910 |
) |
Total operating expenses |
|
|
(198,127 |
) |
|
|
(6,381 |
) |
|
|
(309,707 |
) |
|
|
(10,698 |
) |
|
|
(730,402 |
) |
|
|
(23,524 |
) |
|
|
(802,733 |
) |
|
|
(27,728 |
) |
Loss before income
tax |
|
|
(178,301 |
) |
|
|
(5,742 |
) |
|
|
(233,576 |
) |
|
|
(8,068 |
) |
|
|
(530,331 |
) |
|
|
(17,080 |
) |
|
|
(689,829 |
) |
|
|
(23,828 |
) |
Income tax expense |
|
|
(124 |
) |
|
|
(4 |
) |
|
|
(117 |
) |
|
|
(4 |
) |
|
|
(1,255 |
) |
|
|
(40 |
) |
|
|
(886 |
) |
|
|
(31 |
) |
Net loss |
|
$ |
(178,425 |
) |
|
$ |
(5,746 |
) |
|
$ |
(233,693 |
) |
|
$ |
(8,072 |
) |
|
$ |
(531,586 |
) |
|
$ |
(17,120 |
) |
|
$ |
(690,715 |
) |
|
$ |
(23,859 |
) |
Total other comprehensive
loss |
|
$ |
(1,675 |
) |
|
$ |
(54 |
) |
|
$ |
(183 |
) |
|
$ |
(6 |
) |
|
$ |
(759 |
) |
|
$ |
(25 |
) |
|
$ |
(1,991 |
) |
|
$ |
(69 |
) |
Total comprehensive
loss |
|
$ |
(180,100 |
) |
|
$ |
(5,800 |
) |
|
$ |
(233,876 |
) |
|
$ |
(8,078 |
) |
|
$ |
(532,345 |
) |
|
$ |
(17,145 |
) |
|
$ |
(692,706 |
) |
|
$ |
(23,928 |
) |
Loss per share of common
stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share (in dollars) |
|
$ |
(2.80 |
) |
|
$ |
(0.09 |
) |
|
$ |
(2.78 |
) |
|
$ |
(0.10 |
) |
|
$ |
(8.35 |
) |
|
$ |
(0.27 |
) |
|
$ |
(8.93 |
) |
|
$ |
(0.31 |
) |
About TLC
TLC (NASDAQ: TLC, TWO: 4152) is a
clinical-stage, specialty pharmaceutical company dedicated to the
research and development of novel nanomedicines that maximize the
potential of its proprietary lipid-assembled drug delivery platform
(LipAD™), including BioSeizer® sustained release technology and
NanoX™ active drug loading technology, which are versatile in the
choice of active pharmaceutical ingredients and scalable in
manufacturing. TLC has a diverse, wholly owned portfolio of
therapeutics targeting areas of unmet medical need in pain
management, ophthalmology, oncology and infectious diseases. TLC is
consistently ranked top 5% among all listed companies in Taiwan’s
Corporate Governance Evaluations.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements contained in this
press release include, without limitation, statements regarding
TLC’s expectations regarding the clinical development of TLC’s
product candidates, including TLC599 and TLC19, the clinical
benefits of TLC’s product candidates, the timing, scope, progress
and outcome of TLC’s clinical trials, including TLC599 and TLC19,
how sufficient cash and equivalents will be to fund operations, the
anticipated timelines for the release of clinical data and progress
of TLC’s manufacturing capabilities. Words such as "may,"
"believe," "will," "expect," "plan," "anticipate," "estimate,"
"intend" and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
forward-looking statements are not guarantees of future performance
and involve a number of risks, assumptions, uncertainties and
factors, including risks that the outcome of any clinical trial is
inherently uncertain and product candidates may prove to be unsafe
or ineffective, or may not achieve commercial approval, and delays
or disruptions on our business or clinical trials due to the
COVID-19 pandemic. Other risks are described in the Risk Factors
section of TLC's annual report on Form 20-F for the year ended
December 31, 2019 filed with the U.S. Securities and Exchange
Commission (the “SEC”) as well as subsequent filings with the SEC.
All forward-looking statements are based on TLC's expectations and
assumptions as of the date of this press release. Actual results
may differ materially from these forward-looking statements. Except
as required by law, TLC expressly disclaims any responsibility to
update any forward-looking statement contained herein, whether as a
result of new information, future events or otherwise.
TLC Contact:
Dawn Chi
Corporate Communications
dawn@tlcbio.com
Taiwan Liposome (NASDAQ:TLC)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Taiwan Liposome (NASDAQ:TLC)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024