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TLC Reports First Quarter 2021 Financial Results and Provides Business Update

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2021-05-14

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, TC599 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 (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

)


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