SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Feb. 05, 2021 (GLOBE NEWSWIRE) -- 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 fiscal year ended December 31, 2020 and provided a business update.

“In the tumultuous year that was 2020, we were fortunate enough to have achieved early patient enrollment in the Phase II clinical trial of our postsurgical pain program before COVID-19 began its spread to the United States,” commented George Yeh, President of TLC. “And in the midst of the pandemic, we managed to complete full patient enrollment in the pivotal trial of our osteoarthritis pain program and continue the global expansion of Ampholipad™, all while initiating a clinical trial for inhalable liposomal hydroxychloroquine as a potential treatment for severe lung diseases such as COVID-19. We hope the application of our proprietary technologies can help to put an end to the pandemic. To resonate with the name of our pivotal trial for our osteoarthritis pain program, EXCELLENCE, we will continue to strive for excellence in this very important year to provide the most benefits for patients, physicians and stakeholders alike.”

Clinical Pipeline Update and Upcoming Milestones

Corporate Highlights

Fiscal Year End 2020 Financial Results

Operating revenue for the fiscal year 2020 was NT$101.9 million (US$3.6 million), a 51.3% decrease compared to NT$209.1 million (US$7.0 million) in the fiscal year 2019. Operating expenses for the fiscal year 2020 was NT$1,113.3 million (US$39.6 million), an 8.4% increase compared to NT$1,026.8 million (US$34.3 million) in the fiscal year 2019. Net loss for the fiscal year 2020 was NT$983.3 million (US$35.0 million), compared to a loss of NT$807.5 million (US$27.0 million) in the fiscal year 2019, or a net loss of NT$12.42 (US$0.44) per share for the fiscal year 2020, compared to a net loss of NT$12.32 (US$0.41) per share for the fiscal year 2019.

The Company’s cash and cash equivalents were NT$1,342.7 million (US$47.8 million) as of December 31, 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  December 31, 2020 
  NT$000  US$000  NT$000  US$000 
Cash and cash equivalents and time deposit $1,023,874  $34,232  $1,342,667  $47,816 
Total current assets  1,095,614   36,631   1,431,977   50,997 
Total assets          1,385,978   46,339   1,749,461   62,303 
Total current liabilities  556,697   18,612   348,127   12,398 
Long-term borrowings  55,508   1,856   469,076   16,705 
Total liabilities  664,068   22,202   886,134   31,557 
Total equity  721,910   24,137   863,327   30,746 
                 

Selected Consolidated Statements of Operations Data

  Year ended December 31, 
  2019  2020 
  NT$000  US$000  NT$000  US$000 
Operating revenue $209,140  $6,992  $101,928  $3,630 
Operating expenses                
General and administrative expenses  (166,377)  (5,562)  (145,769)  (5,191)
Research and development expenses  (860,419)  (28,767)  (967,503)  (34,455)
Total operating expenses  (1,026,796)  (34,329)  (1,113,272)  (39,646)
Loss before income tax  (803,402)  (26,861)  (982,177)  (34,978)
Income tax expense  (4,120)  (138)  (1,132)  (40)
Net loss $(807,522) $(26,999) $(983,309) $(35,018)
Total other comprehensive loss $(2,782) $(93) $262  $9 
Total comprehensive loss $(810,304) $(27,092) $(983,047) $(35,009)
Loss per share of common stock                
Basic and diluted loss per share (in dollars) $(12.32) $(0.41) $(12.42) $(0.44)

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.