TLC Reports First Quarter 2021 Financial Results and Provides Business Update
May 14 2021 - 7:32AM
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 first quarter ended March 31, 2021 and provided a business
update.
“The first quarter of 2021 is marked by
continual progress in our lead programs, TLC599 and TLC590, as well
as the global commercialization of Ampholipad, for which we look
forward to announcing the details when they are finalized,”
commented George Yeh, President of TLC. “We are happy to announce
that we have once again made the top 5% ranking in Taiwan’s
corporate governance evaluation. Being the only biotech company to
have achieved this honor seven years in a row, we think this is an
incredible feat and a representation of the company’s dedication to
the principles of transparency, accountability, and security.”
Clinical Pipeline Update and Upcoming
Milestones
- Continuous excellent progress in EXCELLENCE,
the Phase III pivotal clinical trial of TLC599 in ~500 patients
with symptomatic knee osteoarthritis. Over 440 patients have
reached the 24-week timepoint, of whom a majority have received the
second injection of either TLC599 or placebo. There has been 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, as well as a repeat, dose of TLC599 in patients
with knee OA across 46 sites in the United States and
Australia.
- Imminent End-of-Phase 2 meeting with the FDA
on TLC590 for postsurgical
pain. The United States Food and Drug
Administration (FDA) has scheduled an End-of-Phase 2 meeting with
TLC in June to discuss the development plan for TLC590. With the
meeting, TLC hopes to obtain FDA’s input and reach an agreement on
the design parameters of the proposed pivotal clinical studies that
will be used to support the TLC590 NDA application.
- Subsidiary InspirMed to present
potential advantages of ISPM21 and ISPM19 in treating
COVID-19 at 23rd International Society for Aerosols in
Medicine (ISAM) Congress, in a poster titled “A Strategy to Treat
COVID-19 with Targeted Delivery of Inhalable Liposomal Antiviral
Drugs”, which will be posted both on the website (www.isam.org) and
printed for display at the Boise Conference Center for live
presentation in Boise, Idaho, USA, on May 22-26, 2021.
Corporate Highlights
- Once again ranked Top 5% in Corporate
Governance Evaluation amongst all Taiwan Stock Exchange
Corporation (TWSE) and Taipei Exchange (TPEx) listed companies,
marking the seventh consecutive year TLC has won the prestigious
status. TLC was also ranked in the Top 5% in the newly added,
non-industry-specific, Small and Medium-Sized Enterprises (SMEs)
category (TWD 5-10 billion market value), winning praise from TWSE
and TPEx for being a benchmark for all SMEs.
- Partnership discussions for
Ampholipad™ advancing
swimmingly. Strategic partnerships for
the complex generic drug in several territories are nearing
conclusion. Details of the partnerships are expected to be
finalized and announced shortly.
- US$20 million additional financing. Cathay
Bank has issued a term sheet and agrees to provide additional
financing amounting to US$20 million if conditions are
fulfilled.
- Presented the latest updates at investor
conferences, including HC Wainwright & Co Global Life
Sciences Conference (March 9-10, 2021) and Oppenheimer 31st Annual
Healthcare Conference (March 16-17, 2021).
- Expanded global intellectual property protection to 299
patents, with 162 patents granted and 137 applications
worldwide as of March 31, 2021.
First Quarter 2021 Financial
Results
Operating revenue for the first quarter 2021 was
NT$37.6 million (US$1.3 million), a 214.2% increase compared
to NT$12.0 million (US$0.4 million) in the first quarter 2020.
Operating expenses for the first quarter 2021 was
NT$253.8 million (US$8.9 million), an 13.0% increase compared
to NT$224.7 million (US$7.4 million) in the first quarter
2020. Net loss for the first quarter 2021 was NT$218.2 million
(US$7.7 million), compared to a loss of NT$214.6 million
(US$7.1 million) in the first quarter 2020, or a net loss of
NT$2.39 (US$0.08) per share for the first quarter 2021, compared to
a net loss of NT$2.90 (US$0.10) per share for the first quarter
2020.
The Company’s cash and cash equivalents were
NT$1,080.0 million (US$37.9 million) as of March 31,
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 |
|
|
March 31, 2021 |
|
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
Cash and cash equivalents |
|
$ |
1,342,667 |
|
|
$ |
47,816 |
|
|
$ |
1,080,009 |
|
|
$ |
37,922 |
|
Total
current assets |
|
|
1,431,977 |
|
|
|
50,997 |
|
|
|
1,173,607 |
|
|
|
41,208 |
|
Total
assets |
|
|
1,749,461 |
|
|
|
62,303 |
|
|
|
1,509,396 |
|
|
|
52,998 |
|
Total
current liabilities |
|
|
348,127 |
|
|
|
12,398 |
|
|
|
378,463 |
|
|
|
13,289 |
|
Long-term borrowings |
|
|
469,076 |
|
|
|
16,705 |
|
|
|
421,589 |
|
|
|
14,803 |
|
Total
liabilities |
|
|
886,134 |
|
|
|
31,557 |
|
|
|
868,762 |
|
|
|
30,504 |
|
Total
equity |
|
|
863,327 |
|
|
|
30,746 |
|
|
|
640,634 |
|
|
|
22,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selected Consolidated Statements of Operations Data
|
|
Three-month periods ended March 31, |
|
|
|
2020 |
|
|
2021 |
|
|
|
NT$000 |
|
|
US$000 |
|
|
NT$000 |
|
|
US$000 |
|
Operating revenue |
|
$ |
11,974 |
|
|
$ |
396 |
|
|
$ |
37,618 |
|
|
$ |
1,321 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
(32,880 |
) |
|
|
(1,087 |
) |
|
|
(31,047 |
) |
|
|
(1,090 |
) |
Research and development expenses |
|
|
(191,778 |
) |
|
|
(6,340 |
) |
|
|
(222,774 |
) |
|
|
(7,822 |
) |
Total operating expenses |
|
|
(224,658 |
) |
|
|
(7,427 |
) |
|
|
(253,821 |
) |
|
|
(8,912 |
) |
Loss before income tax |
|
|
(214,164 |
) |
|
|
(7,080 |
) |
|
|
(217,998 |
) |
|
|
(7,655 |
) |
Income tax expense |
|
|
(421 |
) |
|
|
(14 |
) |
|
|
(239 |
) |
|
|
(8 |
) |
Net loss |
|
$ |
(214,585 |
) |
|
$ |
(7,094 |
) |
|
$ |
(218,237 |
) |
|
$ |
(7,663 |
) |
Total other comprehensive loss |
|
$ |
(3,506 |
) |
|
$ |
(116 |
) |
|
$ |
(8,195 |
) |
|
$ |
(288 |
) |
Total comprehensive loss |
|
$ |
(218,091 |
) |
|
$ |
(7,210 |
) |
|
$ |
(226,432 |
) |
|
$ |
(7,951 |
) |
Loss per share of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share (in dollars) |
|
$ |
(2.90 |
) |
|
$ |
(0.10 |
) |
|
$ |
(2.39 |
) |
|
$ |
(0.08 |
) |
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 in the 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 and product candidates, including Ampholipad, TLC599,
TLC590 and TLC19, 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 Ampholipad, 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
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