On February 11, 2020 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, reported financial results for the fiscal year ended December 31, 2019, and provided a business update (Press release, Taiwan Liposome Company, FEB 11, 2020, View Source [SID1234554167]).
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"We saw a monumental year for TLC in 2019, marked not only by tremendous clinical and manufacturing advancements in both our programs in pain management – TLC599 and TLC590, but also by new business development agreements, addition of internationally experienced personnel to the management team, and presentation and publication of impressive data at numerous investor conferences as well as prestigious scientific conventions," said George Yeh, President of TLC. "With this continual momentum, we look forward to achieving more milestones in 2020, including the completion of patient enrollment in the EXCELLENCE trial and data readout from the TLC590 Phase II trial, both of which will bring us closer to the goal of mitigating the proliferation of highly addictive opioids with the availability of our non-opioid alternatives."
Clinical Pipeline Update and Upcoming Milestones
Commencement of patient enrollment in EXCELLENCE trial evaluating single and repeated administrations of TLC599 for knee osteoarthritis pain. The Phase III pivotal study, which enrolled its first patient in November 2019, will dose about 500 patients at a 2:1:1 ratio with TLC599, dexamethasone or placebo across 45 sites in the United States and Australia. At Week 24, patients can receive a second blinded injection of TLC599 or placebo. Primary endpoint is the magnitude of pain relief by WOMAC Pain score versus placebo at Week 16 and Week 40. Patient enrollment is expected to take about one year, and all patients will be followed for 52 weeks.
Commencement of patient dosing in Part 2 of Phase II trial evaluating the analgesic efficacy of TLC590 following bunionectomy. With the first batch of patients dosed in January 2020, a total of about 150 patients will receive TLC590, bupivacaine or normal saline placebo at a ratio of 1:1:1 at the end of their bunion removal surgery. Primary endpoint is area under the curve (AUC) from 0 to 72 hours on the numerical pain rating scale.
Corporate Highlights
Completed US$27.3 million financing. The Company completed a cash capital offering of ordinary (common) shares in Taiwan in October 2019. The offering consisted of 10,200,000 new common shares issued at a price of NT$82 per common share for gross proceeds of NT$836.4 million (~US$27.3 million).
Presented at Berenberg Pain Seminar and JP Morgan Healthcare Conference. At the Berenberg Pain Seminar in November 2019, TLC presented recent data on TLC599 and TLC590 and discussed how they can potentially deter the spread of the opioid crisis with prominent figures in the pain management space. TLC also presented and participated in one-on-one meetings at the 38th annual JP Morgan Healthcare Conference in January 2020, marking the Company’s sixth consecutive attendance at the world’s largest healthcare investment symposium.
Expanded global intellectual property protection to 197 patents, with 126 patents granted and 71 applications worldwide as of December 31, 2019.
Fiscal Year End Financial Results
Operating revenue for the fiscal year 2019 was NT$209.1 million (US$7.0 million), a 235.6% increase compared to NT$62.3 million (US$2.0 million) in the fiscal year 2018. Operating expenses for the fiscal year 2019 was NT$1,026.8 million (US$34.3 million), a 4.7% increase compared to NT$980.3 million (US$32.0 million) in the fiscal year 2018. Net loss for the fiscal year 2019 was NT$807.5 million (US$27.0 million), compared to net loss of NT$901.6 million (US$29.5 million) in the fiscal year 2018, or a net loss of NT$12.32(US$0.41) per share for the fiscal year 2019, compared to a net loss of NT$14.37(US$0.47) per share for the fiscal year 2018.
The Company’s cash and cash equivalents and time deposits with maturity over three months (which are classified as "current financial assets at amortized cost" in the Company’s consolidated financial statements) were NT$1,023.9 million (US$34.2 million) as of December 31, 2019, compared to NT$1,114.6 million (US$36.4 million) as of December 31, 2018.