Zymeworks Reports Fourth Quarter and Full Year 2022 Financial Results
Zymeworks Inc. (ZYME) reported a significant turnaround in 2022, achieving $412.5 million in total revenue, a sharp increase from $26.7 million in 2021. The company posted a net income of $124.3 million ($1.90 per share) compared to a net loss of $211.8 million in the previous year. Cash resources stand at $492.2 million, ensuring a runway through 2026. Key developments include positive Phase 2 study results for zanidatamab and a substantial licensing agreement with Jazz Pharmaceuticals, potentially worth up to $1.76 billion. Zymeworks aims to advance multiple clinical studies and develop five novel product candidates over the next five years.
- Total revenue increased to $412.5 million in 2022 from $26.7 million in 2021.
- Achieved net income of $124.3 million compared to a net loss of $211.8 million in 2021.
- Established a collaboration with Jazz Pharmaceuticals potentially worth up to $1.76 billion.
- Positive data reported from pivotal Phase 2 studies of zanidatamab, showing a median duration of response of 12.9 months.
- Cash resources of $492.2 million ensure operations through at least 2026.
- Research and development expenses rose to $208.6 million in 2022 from $199.8 million in 2021.
- General and administrative expenses increased significantly to $73.4 million in 2022 from $42.6 million in 2021.
-
2022 was a year of transformation and change:
-
reported
in total revenue for the year ended$412.5 million December 31, 2022 ; -
reported net income of
($124.3 million per fully diluted share) for 2022 compared to net loss of$1.90 in 2021;$211.8 million -
reported
in cash resources as of$492.2 million December 31, 2022 , with expected cash runway through 2026; - announced positive top-line data for pivotal Phase 2 study of zanidatamab monotherapy in 2L+ patients with HER2-amplified advanced biliary tract cancers (BTC);
- presented updated results at ASCO GI, including overall survival data, for ongoing Phase 2 study of zanidatamab in 1L patients with HER2-expressing metastatic gastroesophageal adenocarcinoma (GEA);
- closed significant collaboration for zanidatamab with Jazz Pharmaceuticals in the fourth quarter, completing a series of financial transformation initiatives in 2022; and
-
discussed new preclinical product candidates at early Research & Development Day in
October 2022 with investigational new drug (IND) filings for ZW171 and ZW191 on track for 2024.
-
reported
-
Acceptance of 11 submitted abstracts to be presented at AACR in
April 2023 to highlight R&D pipeline. - Announced recommended Phase 2 dose (RP2D) for Phase 2 studies of zanidatamab zovodotin scheduled to commence in 2023.
-
Will host conference call with management today at
4:30 p.m. Eastern Standard Time (EST).
“As I reflect on the past year as
Recent Highlights and Current Developments
-
Completion of Zanidatamab Licensing Agreement with Jazz Pharmaceuticals
During the fourth quarter of 2022, we advanced a significant licensing and collaboration agreement with Jazz Pharmaceuticals plc (Jazz) for the exclusive license to develop and commercialize zanidatamab throughout the world except for thoseAsia-Pacific territories previously licensed to BeiGene, Ltd. ThroughDecember 31, 2022 , we received in upfront payments and are eligible for reimbursement of ongoing zanidatamab-related costs expended after$375 million October 19, 2022 . We remain eligible to receive up to upon the achievement of certain regulatory approval milestones and up to$525 million in potential commercial milestone payments, for total potential payments of up to$862.5 million . Pending approval of zanidatamab, we are eligible to receive tiered royalties between$1.76 billion 10% and20% on Jazz's annual net sales of zanidatamab.
-
Zanidatamab Continues to Advance with Multiple Upcoming Clinical Catalysts
HERIZON-GEA-01, a global, pivotal study evaluating zanidatamab in 1L HER2-positive GEA, continues to enroll patients with expected top-line data in 2024. Data presented at the ASCO Gastrointestinal Cancers Symposium inJanuary 2023 showed84% overall survival at 18 months in 1L HER2-positive GEA patients treated with zanidatamab and standard chemotherapy. HERIZON-BTC-01, a pivotal study evaluating zanidatamab as monotherapy in previously-treated advanced HER2-amplified BTC patients, reported positive top-line data that41.3% of enrolled patients with HER2-amplified and -expressing (IHC2+ and 3+) disease achieved a confirmed objective response rate (cORR) and a median duration of response of 12.9 months as assessed by independent central review. In conjunction with Jazz, we expect to present the full data set from HERIZON-BTC-01 at a major medical meeting in the first half of 2023. Zanidatamab was also recently selected for inclusion in the I-SPY platform trials for patients with HER2-expressing tumors in neoadjuvant treatment of locally advanced breast cancer, which continues to explore the potential use of zanidatamab in indications outside of GEA and BTC.
-
Eleven Abstracts Accepted for Presentation at AACR Meeting in April
Zymeworks had 11 abstracts accepted for presentation at the 2023American Association for Cancer Research (AACR) meeting taking placeApril 14-19 inOrlando, Florida . We look forward to sharing additional information on our preclinical product candidates and zanidatamab zovodotin.Zymeworks plans to host a conference call discussing these data in April after the presentation of all abstracts. Additionally, during 2023 we expect to nominate an additional preclinical product candidate with a goal of an expected IND filing by 2025.
-
Zanidatamab Zovodotin (ZW49) to Progress in Phase 2 Clinical Trial
With the announcement of the recommended Phase 2 dose (RP2D) of 2.5 mg/kg every three weeks, development of zanidatamab zovodotin continues with multiple Phase 2 studies expected to commence enrollment in 2023. We continue to explore potential development and commercial collaborations prior to undertaking any registrational studies of zanidatamab zovodotin, which are expected to commence before the end of 2025 at the earliest.
5 by 5 Research & Development Strategy
"We have set an ambitious target of generating five novel product candidates to move into clinical studies over the next five years, starting with INDs for both ZW171 and ZW191 in 2024," stated
ZW171, our lead multispecific candidate, is a 2+1 bispecific antibody designed to co-engage tumor cells and immune cells (T cells) to enable T cell-mediated killing of tumor cells. ZW171 binds to the tumor target mesothelin (MSLN), which is expressed on many different tumors including pancreatic, mesothelioma, ovarian, and other mid to high MSLN-expressing cancers. Our team engineered and optimized the antibody design by layering our complementary technologies, including the use of Azymetric™ and EFECT™.
ZW191, our lead antibody-drug conjugate (ADC) candidate, is engineered to target the folate receptor-alpha protein expressed on a variety of tumors. ZW191 delivers a cytotoxic chemotherapy, topoisomerase-1 inhibitor, to these tumor cells to kill the cancer. Using our Azymetric and Drug Conjugate technologies, our team customized the monoclonal antibody with enhanced internalization characteristics in order to potentially target high, mid, and low levels of folate receptor-alpha expression.
We also continue to have active licensing agreements with key pharmaceutical and biotechnology partners through our portfolio of legacy platform licensing agreements. Through this portfolio, we have received approximately
Leadership Appointments
During January, we made two key appointments in the clinical development organization with
Financial Results for the Year Ended
Revenue was
Research and development expense was
We expect research and development expenditures to increase over time, subject to periodic fluctuations that are in line with the advancement, expansion, and completion of the clinical development of our product candidates, as well as our ongoing preclinical research activities. As of
General and administrative expense was
Net income was
"2022 was a very exciting year for
As of
About
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities; the anticipated benefits of the license agreement with Jazz, including Zymeworks’ ability to receive any future milestone payments and royalties thereunder; the potential addressable market of zanidatamab; the timing of and results of interactions with regulators; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; anticipated clinical data presentations, including the expected presentation of full results from HERIZON-BTC-01 in 2023 expectations regarding future regulatory filings and approvals and the timing thereof; potential therapeutic effects of zanidatamab and Zymeworks’ other product candidates; expected financial performance and future financial position; the commercial potential of technology platforms and product candidates; anticipated continued receipt of revenue from existing and future partners; Zymeworks’ preclinical pipeline; anticipated sufficiency of cash resources and other potential sources of cash, including anticipated payments from Jazz, to fund Zymeworks’ planned operations through at least 2026, and potentially beyond; Zymeworks’ anticipated net operating cash burn and planned capital expenditures in 2023; Zymeworks’ ability to execute new collaborations and partnerships and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “progress”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions.
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Consolidated Statements of Income (Loss) and Comprehensive Income (Loss) |
|||||||||||||||
(Expressed in thousands of |
|||||||||||||||
|
Three Months Ended |
|
Year Ended |
||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
|
(unaudited) |
|
(unaudited) |
|
|
|
|
||||||||
Revenue |
|
|
|
|
|
|
|
||||||||
Research and development collaborations |
$ |
402,493 |
|
|
$ |
19,870 |
|
|
$ |
412,482 |
|
|
$ |
26,680 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Research and development |
|
52,967 |
|
|
|
54,865 |
|
|
|
208,596 |
|
|
|
199,752 |
|
General and administrative |
|
30,131 |
|
|
|
5,854 |
|
|
|
73,358 |
|
|
|
42,561 |
|
Total operating expenses |
|
83,098 |
|
|
|
60,719 |
|
|
|
281,954 |
|
|
|
242,313 |
|
Income (loss) from operations |
|
319,395 |
|
|
|
(40,849 |
) |
|
|
130,528 |
|
|
|
(215,633 |
) |
Other income, net |
|
1,041 |
|
|
|
326 |
|
|
|
4,706 |
|
|
|
3,274 |
|
Income (loss) before income taxes |
|
320,436 |
|
|
|
(40,523 |
) |
|
|
135,234 |
|
|
|
(212,359 |
) |
Income tax (expense) recovery, net |
|
(11,005 |
) |
|
|
1,371 |
|
|
|
(10,893 |
) |
|
|
516 |
|
Net income (loss) and comprehensive loss |
$ |
309,431 |
|
|
$ |
(39,152 |
) |
|
$ |
124,341 |
|
|
$ |
(211,843 |
) |
Net income (loss) per common share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
4.65 |
|
|
$ |
(0.76 |
) |
|
$ |
1.91 |
|
|
$ |
(4.11 |
) |
Diluted |
$ |
4.65 |
|
|
$ |
(0.95 |
) |
|
$ |
1.90 |
|
|
$ |
(4.61 |
) |
Weighted-average common stock outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
66,510,825 |
|
|
|
51,841,032 |
|
|
|
65,194,775 |
|
|
|
51,553,869 |
|
Diluted |
|
66,565,937 |
|
|
|
52,226,549 |
|
|
|
65,249,184 |
|
|
|
52,131,596 |
|
|||||||
Selected Consolidated Balance Sheet Data |
|||||||
(Expressed in thousands of |
|||||||
|
|
|
|
||||
|
|
|
|
||||
Cash, cash equivalents and short-term investments |
$ |
492,232 |
|
|
$ |
252,608 |
|
Working capital |
|
449,081 |
|
|
|
216,367 |
|
Total assets |
|
648,725 |
|
|
|
389,132 |
|
Accumulated deficit |
|
(558,763 |
) |
|
|
(683,104 |
) |
Total stockholders’ equity |
|
492,956 |
|
|
|
249,094 |
|
NON-GAAP FINANCIAL MEASURES
In addition to reporting financial information in accordance with
Adjusted expenses are a non-GAAP measure that
GAAP to Non-GAAP Reconciliations |
|||||||||||||||
(Expressed in thousands of |
|||||||||||||||
(unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Year Ended |
||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
Research and development expenses |
$ |
52,967 |
|
|
$ |
54,865 |
|
|
$ |
208,596 |
|
|
$ |
199,752 |
|
Stock-based compensation (expense) / recovery for equity classified instruments (*) |
|
(1,724 |
) |
|
|
(4,401 |
) |
|
|
(3,174 |
) |
|
|
(20,090 |
) |
Stock-based compensation (expense) / recovery for liability classified instruments (*) |
|
9 |
|
|
|
1,461 |
|
|
|
781 |
|
|
|
4,646 |
|
Restructuring (expense) / recovery |
|
482 |
|
|
|
— |
|
|
|
(5,659 |
) |
|
|
— |
|
Adjusted research and development expenses (Non-GAAP basis) |
$ |
51,734 |
|
|
$ |
51,925 |
|
|
$ |
200,544 |
|
|
$ |
184,308 |
|
|
|
|
|
|
|
|
|
||||||||
General and administrative expenses |
$ |
30,131 |
|
|
$ |
5,854 |
|
|
$ |
73,358 |
|
|
$ |
42,561 |
|
Stock-based compensation (expense) / recovery for equity classified instruments (*) |
|
(2,580 |
) |
|
|
(3,924 |
) |
|
|
(4,102 |
) |
|
|
(18,184 |
) |
Stock-based compensation (expense) / recovery for liability classified instruments (*) |
|
(117 |
) |
|
|
8,753 |
|
|
|
2,893 |
|
|
|
23,758 |
|
Restructuring expense |
|
(476 |
) |
|
|
— |
|
|
|
(3,265 |
) |
|
|
— |
|
Adjusted general and administrative expenses (Non-GAAP basis) |
$ |
26,958 |
|
|
$ |
10,683 |
|
|
$ |
68,884 |
|
|
$ |
48,135 |
|
|
|
|
|
|
|
|
|
||||||||
|
Three Months Ended |
|
Year Ended |
||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
Net income (loss) per common share – Basic |
$ |
4.65 |
|
|
$ |
(0.76 |
) |
|
$ |
1.91 |
|
|
$ |
(4.11 |
) |
Stock-based compensation expense (recovery) per common share |
|
0.06 |
|
|
|
(0.04 |
) |
|
|
0.05 |
|
|
|
0.19 |
|
Restructuring expenses per common share |
|
— |
|
|
|
— |
|
|
|
0.14 |
|
|
|
— |
|
Adjusted net income (loss) per common share – Basic (Non-GAAP basis) |
$ |
4.71 |
|
|
$ |
(0.80 |
) |
|
$ |
2.10 |
|
|
$ |
(3.92 |
) |
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per common share – Diluted |
$ |
4.65 |
|
|
$ |
(0.95 |
) |
|
$ |
1.90 |
|
|
$ |
(4.61 |
) |
Stock-based compensation expense (recovery) per common share |
|
0.06 |
|
|
|
(0.04 |
) |
|
|
0.05 |
|
|
|
0.19 |
|
Restructuring expenses per common share |
|
— |
|
|
|
— |
|
|
|
0.14 |
|
|
|
— |
|
Adjusted net income (loss) per common share – Diluted (Non-GAAP basis) |
$ |
4.71 |
|
|
$ |
(0.99 |
) |
|
$ |
2.09 |
|
|
$ |
(4.42 |
) |
(*): Research and development expenses and general and administrative expenses include stock-based compensation recovery related to the restructuring of |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230307005535/en/
Investor Inquiries:
Director, Investor Relations
(604) 678-1388
ir@zymeworks.com
Media Inquiries:
Director, Corporate Communications
(604) 678-1388
media@zymeworks.com
Source:
FAQ
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