TLC Reports Second Quarter 2021 Financial Results and Provides Business Update
12 August 2021 - 7:44PM
TLC, a clinical-stage specialty pharmaceutical company developing
novel nanomedicines to target areas of unmet medical need, today
announced financial results for the second quarter ended June 30,
2021 and provided a business update.
“The second quarter of 2021 was marked mainly by
the timely approval of our liposomal amphotericin B product in
India and the immediate partnerships for their commercialization
and sales in the territory,” commented George Yeh, President of
TLC. “We are grateful to have the ability to be of assistance in
this humanitarian crisis brought about by the COVID-19 pandemic by
fulfilling an unmet need, and will continue our quest to provide
best-in-class treatments in pain management, ophthalmology,
oncology, as well as infectious diseases.”
Clinical Pipeline Update and Upcoming
Milestones
- All
subjects have reached the 24-week timepoint in EXCELLENCE.
The Phase III pivotal clinical trial of TLC599 in ~500 subjects is
progressing smoothly, with all subject having reached the 24-week
timepoint and the majority of whom having received the second
injection of either TLC599 or placebo. There remains no safety
concerns or serious adverse events related to treatment. The
multi-center, randomized, double-blind, active comparator- and
placebo-controlled pivotal study is evaluating the efficacy and
safety of a single and a repeat dose of TLC599 in patients with
knee osteoarthritis across 46 sites in the United States and
Australia.
- Pivotal
clinical trial of TLC590 to kick
off soon. Following a fruitful End-of-Phase 2 meeting with
the United States Food and Drug Administration (FDA), TLC has
accrued additional guidelines on the design parameters for the
pivotal clinical trials of TLC590 for post-operative pain and will
be kicking off the next trial soon.
-
Liposomal amphotericin B receives approval
in India. The Central Drugs Standard
Control Organization (CDSCO) of India approved the New Drug
Application (NDA) of Amphotericin B Liposome for Injection 50mg
(known as Ampholipad® in Taiwan and AmphoTLC™ in India). The
registration allows for immediate importation per approved usage
and indication to aid in the country’s acute shortage of treatments
for COVID-19 associated mucormycosis.
-
Presented data on advantages of inhalable
liposome formulations of antiviral drugs for lung
diseases at ISAM. At the 23rd International Society for
Aerosols in Medicine (ISAM) Congress, TLC’s subsidiary, InspirMed,
presented data from pharmacokinetic studies on ISPM21 (inhalable
liposomal GS-441524, main plasma metabolite of remdesivir), and
ISPM19 (inhalable liposomal hydroxychloroquine) that showed
significantly higher concentrations in the lungs than their
conventional counterparts, suggesting feasibility of higher dosing
without hepatotoxicity or nephrotoxicity as an improvement upon
current treatments.
Corporate Highlights
-
Commercialization of liposomal amphotericin B in
India. Following the new drug registration, TLC entered
non-exclusive partnerships with Zydus Healthcare Limited and
Strides Pharma Science Limited to begin immediate distribution of
its liposomal amphotericin B product in India.
-
Partnership with Endo International
plc for the commercialization of a liposomal product. TLC
is eligible to receive upfront and subsequent milestone payments as
well as a double-digit share of the net profits from product sales
in the United States.
- Stock
swap and restructuring. Details of the
share swap transactions and restructuring with Woods Investment
Company, along with a list of frequently asked questions, can be
found on the company website (www.tlcbio.com) under
Investors/Shareholder Resources/Share Swap.
- Expanded
global intellectual property protection to
314 patents, with 165 patents
granted and 149 applications worldwide as of June 30, 2021.
Financial Results
Operating revenue for the second quarter of
fiscal 2021 was NT$160.2 million (US$5.7 million), a 1,260.2%
increase compared to NT$11.8 million (US$0.4 million) in the
second quarter of fiscal 2020. Operating expenses for the second
quarter of fiscal 2021 was NT$251.7 million (US$9.0 million),
a 6.2% decrease compared to NT$268.4 million (US$9.1 million)
in the second quarter of fiscal 2020. Net loss for the second
quarter of fiscal 2021 was NT$75.5 million (US$2.7 million),
compared to a loss of NT$242.4 million (US$8.2 million) in the
second quarter of 2020, or a net loss of NT$0.66 (US$0.02) per
share for the second quarter of fiscal 2021, compared to a net loss
of NT$3.28 (US$0.11) per share for the second quarter of fiscal
2020.
The Company’s cash and cash equivalents were
NT$696.7 million (US$25.0 million) as of June 30, 2021,
compared to NT$1,342.7 million (US$47.8 million) as of
December 31, 2020.
Financial Summary
Selected Consolidated Balance Sheet Data
|
|
|
December 31, 2020 |
|
|
June 30, 2021 |
|
| |
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
|
Cash and cash equivalents and time deposit |
|
$ |
1,342,667 |
|
|
$ |
47,816 |
|
|
$ |
696,737 |
|
|
$ |
24,964 |
|
| Total current assets |
|
|
1,431,977 |
|
|
|
50,997 |
|
|
|
986,874 |
|
|
|
35,359 |
|
| Total assets |
|
|
1,749,461 |
|
|
|
62,303 |
|
|
|
1,330,969 |
|
|
|
47,688 |
|
| Total current liabilities |
|
|
348,127 |
|
|
|
12,398 |
|
|
|
327,849 |
|
|
|
11,747 |
|
| Long-term borrowings |
|
|
469,076 |
|
|
|
16,705 |
|
|
|
372,809 |
|
|
|
13,357 |
|
| Total liabilities |
|
|
886,134 |
|
|
|
31,557 |
|
|
|
775,191 |
|
|
|
27,775 |
|
| Total equity |
|
|
863,327 |
|
|
|
30,746 |
|
|
|
555,778 |
|
|
|
19,913 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Consolidated Statements of Operations Data
| |
|
Three-month periods ended June 30, |
|
|
Six-month periods ended June 30, |
|
| |
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
| |
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
|
Operating revenue |
|
$ |
11,776 |
|
|
$ |
400 |
|
|
$ |
160,176 |
|
|
$ |
5,739 |
|
|
$ |
23,750 |
|
|
$ |
807 |
|
|
$ |
197,794 |
|
|
$ |
7,087 |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
(39,487 |
) |
|
|
(1,341 |
) |
|
|
(31,622 |
) |
|
|
(1,133 |
) |
|
|
(72,367 |
) |
|
|
(2,458 |
) |
|
|
(62,669 |
) |
|
|
(2,245 |
) |
|
Research and development expenses |
|
|
(228,881 |
) |
|
|
(7,774 |
) |
|
|
(220,087 |
) |
|
|
(7,886 |
) |
|
|
(420,659 |
) |
|
|
(14,289 |
) |
|
|
(442,861 |
) |
|
|
(15,868 |
) |
|
Total operating expenses |
|
|
(268,368 |
) |
|
|
(9,115 |
) |
|
|
(251,709 |
) |
|
|
(9,019 |
) |
|
|
(493,026 |
) |
|
|
(16,747 |
) |
|
|
(505,530 |
) |
|
|
(18,113 |
) |
| Loss before income
tax |
|
|
(242,089 |
) |
|
|
(8,223 |
) |
|
|
(75,144 |
) |
|
|
(2,692 |
) |
|
|
(456,253 |
) |
|
|
(15,498 |
) |
|
|
(293,142 |
) |
|
|
(10,503 |
) |
|
Income tax expense |
|
|
(348 |
) |
|
|
(12 |
) |
|
|
(363 |
) |
|
|
(13 |
) |
|
|
(769 |
) |
|
|
(26 |
) |
|
|
(602 |
) |
|
|
(22 |
) |
| Net loss |
|
$ |
(242,437 |
) |
|
$ |
(8,235 |
) |
|
$ |
(75,507 |
) |
|
$ |
(2,705 |
) |
|
$ |
(457,022 |
) |
|
$ |
(15,524 |
) |
|
$ |
(293,744 |
) |
|
$ |
(10,525 |
) |
| Total other comprehensive
loss |
|
$ |
1,698 |
|
|
$ |
58 |
|
|
$ |
(13,090 |
) |
|
$ |
(469 |
) |
|
$ |
(1,808 |
) |
|
$ |
(61 |
) |
|
$ |
(21,285 |
) |
|
$ |
(762 |
) |
| Total comprehensive
loss |
|
$ |
(240,739 |
) |
|
$ |
(8,177 |
) |
|
$ |
(88,597 |
) |
|
$ |
(3,174 |
) |
|
$ |
(458,830 |
) |
|
$ |
(15,585 |
) |
|
$ |
(315,029 |
) |
|
$ |
(11,287 |
) |
| Loss per share of common
stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and diluted loss
per share (in dollars) |
|
$ |
(3.28 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.66 |
) |
|
$ |
(0.02 |
) |
|
$ |
(6.18 |
) |
|
$ |
(0.21 |
) |
|
$ |
(3.05 |
) |
|
$ |
(0.11 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About TLC
TLC 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.
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 and product candidates, including Ampholipad, TLC599,
TLC590, ISPM21 and ISPM19, the clinical benefits of TLC’s products
and product candidates, the timing, scope, progress and outcome of
TLC’s clinical trials and regulatory communications, the timing,
scope, progress and outcome of TLC’s collaborations and
partnerships, the commercialization of TLC’s products, 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, 2020 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
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