Zymeworks Reports 2020 Year-End Financial Results

Rhea-AI Summary

Zymeworks Inc. (NYSE: ZYME) reported a 32% revenue increase in 2020, reaching $39.0 million, up from $29.5 million in 2019. The growth was driven by milestone payments from partnerships. Research and development expenses rose significantly to $168.5 million, reflecting expanded clinical trials for zanidatamab and ZW49. The company received a Breakthrough Therapy designation for zanidatamab, paving the way for pivotal trials in 2021. Additionally, Zymeworks strengthened its balance sheet with a $320.8 million public financing.

Positive

• Revenue increased to $39.0 million in 2020, up 32% from 2019.
• Zanidatamab received Breakthrough Therapy designation, facilitating expedited trials.
• Strong partnerships leading to potential milestone payments of $8.6 billion.

Negative

• R&D expenses surged to $168.5 million, a 45% increase from 2019.
• General and administrative expenses, although decreased, remain high at $57.9 million.

Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported financial results for the year ended December 31, 2020 and provided a summary of recent business and clinical highlights.

“Throughout 2020, we initiated and advanced several clinical trials and achieved important regulatory milestones for zanidatamab and ZW49,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “This has set up 2021 to be a data-rich year for both of our lead clinical assets as well as new preclinical candidates and therapeutic platforms, and we are well resourced to deliver on our priorities.”

2020 Business Highlights and Recent Developments

• Clinical Data Continues to Support Goal of Establishing Zanidatamab as the Foundational HER2 Targeted Therapy Across Multiple HER2-Positive Cancers
  Updated clinical data was recently presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium for zanidatamab, in both HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA). Overall zanidatamab was well tolerated with the majority of treatment-related adverse events being mild or moderate in severity. With respect to antitumor activity, both refractory BTC and GEA compare favorably to current standard of care and emerging treatments. These data support zanidatamab's broad therapeutic potential as a foundational therapy across multiple HER2-expressing cancers.

• Zanidatamab Advances in Accelerated Pivotal Trial Paving the Way for Commercialization
  The U.S. Food and Drug Administration granted Breakthrough Therapy designation to zanidatamab for BTC, enabling an Accelerated Approval pathway for the global pivotal trial (HERIZON-BTC-01) for zanidatamab monotherapy in patients with previously treated HER2 gene-amplified BTC and submission of a Biologics License Application (BLA) as early as 2022. A second pivotal trial evaluating zanidatamab as first-line treatment for advanced HER2-positive GEA is on track to launch mid-2021. Zanidatamab received additional drug review special designations in the U.S. and the European Union that are expected to help to expedite clinical development of both trials.

• ZW49 Demonstrates Antitumor Activity and Differentiated Safety Profile; Expansion Cohorts Enrolling while Dose Escalation Continues
  ZW49, a bispecific antibody-drug conjugate targeting HER2, has begun enrolling patients into the expansion cohort portion of the ongoing Phase 1 clinical trial. Interim data were recently presented and showed no dose limiting toxicities or treatment-related hematologic, pulmonary, or liver toxicity. The majority of treatment-related adverse events were mild or moderate in severity with the most common being keratitis, fatigue, and diarrhea. ZW49 demonstrated antitumor activity at all dose levels evaluated in the once every three week regimen, including confirmed partial responses and stable disease per RECIST 1.1., and dose escalation is continuing at 3 mg/kg once every three weeks. Three indication-specific expansion cohorts (HER2-positive breast cancer, HER2-positive GEA, and a basket cohort of other HER2-positive cancers) utilizing the 2.5 mg/kg once every three week regimen have also been initiated to better ascertain antitumor activity in more homogeneous patient populations.

• Milestone Payments Received and Deal Values Increase for Partnership Deals
  Throughout 2020, partnerships continued to expand and additional milestones were achieved upon BeiGene initiating multiple clinical studies with zanidatamab, Merck and BMS expanding Azymetric™ and EFECT™ collaborations, and Iconic/Exelixis entering into a licensing deal for a ZymeLink™ ADC. Zymeworks has nine active collaborations that could result in up to $8.6 billion in potential milestone payments in addition to royalties on potential product sales.

• Strengthened Balance Sheet
  In January 2020, Zymeworks completed an upsized $320.8 million public financing to accelerate and expand global development of its lead clinical candidates, zanidatamab and ZW49, and support further advancement of its novel preclinical programs.

Financial Results for the Year Ended December 31, 2020

Revenue was $39.0 million in 2020 compared to $29.5 million in 2019. For both years, revenue related to non-recurring upfront fees, milestone payments, option fees, research support and other payments under our licensing and collaboration agreements. Revenue for 2020 included $15.0 million from BeiGene for development milestones, $12.0 million from BMS for an expansion fee and $12.0 million from other partners for research support, partner revenue, drug supply and other payments. Revenue for 2019 included $8.0 million from Lilly for achievement of a development milestone, $7.5 million and $3.5 million from BMS and Daiichi Sankyo, respectively, for exercise of commercial license options, $3.5 million for recognition of deferred revenue relating to our licensing and collaboration agreement with BeiGene, and $7.0 million from our partners for other development milestones, research support and other payments.

Research and development expense was $168.5 million in 2020 compared to $115.9 million in 2019. The $52.6 million increase related primarily to additional clinical trial activities and associated drug manufacturing costs for zanidatamab, as well as an increase in salaries and benefits expense resulting from a higher headcount. Expenses also increased in 2020 for higher development activity for ZW49 and an increase in-licensing and milestone payments for discovery and research activities. Research and development expense included non-cash stock-based compensation expense of $12.3 million in 2020 and $14.3 million in 2019.

General and administrative expense was $57.9 million in 2020 compared to $64.2 million in 2019. General and administrative expense included non-cash stock-based compensation expense of $16.1 million in 2020 and $34.2 million in 2019. Excluding stock-based compensation expense, general and administrative

FAQ

What were Zymeworks' 2020 financial results?

Zymeworks reported $39.0 million in revenue for 2020, a 32% increase from $29.5 million in 2019.

What is the significance of the Breakthrough Therapy designation for Zymeworks?

The designation for zanidatamab allows for an Accelerated Approval pathway for pivotal trials, expected to enhance development speed.

How much did Zymeworks raise in its January 2020 financing?

Zymeworks completed a $320.8 million public financing in January 2020 to support its clinical candidates.

What contributed to Zymeworks' increase in R&D expenses in 2020?

The increase to $168.5 million was primarily due to expanded clinical trial activities and higher staffing costs.

What are Zymeworks' upcoming milestones for zanidatamab?

Zymeworks plans to submit a Biologics License Application (BLA) for zanidatamab as early as 2022.