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 expense increased
by $11.9 million year over year primarily due to an increase in
salaries and benefits expense resulting from a higher headcount, as
well as higher insurance and professional services expenses.
Net loss was $180.6 million in 2020 compared to $145.4 million
in 2019. The increase in net loss was primarily due to the
increases in research and development expenses referred to above
partially offset by lower general and administrative expense and
higher revenue and other income.
Zymeworks expects research and development expenditures to
increase over time in line with the advancement and expansion of
the Company’s clinical development of its product candidates, as
well as its ongoing preclinical research activities. Additionally,
Zymeworks anticipates continuing to receive revenue from its
existing and future strategic partnerships, including technology
access fees and milestone-based payments. However, Zymeworks’
ability to receive these payments is dependent upon either
Zymeworks or its collaborators successfully completing specified
research and development activities.
As of December 31, 2020, Zymeworks had $451.6 million in cash
resources consisting of cash, cash equivalents, short-term
investments and certain long-term investments.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the development of next-generation multifunctional
biotherapeutics. Zymeworks’ suite of therapeutic platforms and its
fully integrated drug development engine enable precise engineering
of highly differentiated product candidates. Zymeworks’ lead
clinical candidate, zanidatamab (ZW25), is a novel Azymetric™
bispecific antibody which has been granted Breakthrough Therapy
designation by the FDA and is currently enrolling in a pivotal
clinical trial for refractory HER2-amplified biliary tract cancer
(HERIZON-BTC-01) as well as several Phase 2 clinical trials for
HER2-expressing gastroesophageal and breast cancers. Zymeworks’
second clinical candidate, ZW49, is a novel bispecific
HER2-targeting antibody-drug conjugate currently in Phase 1
clinical development and combines the unique design and antibody
framework of zanidatamab with Zymeworks’ proprietary ZymeLink™
linker and cytotoxin. Zymeworks is also advancing a deep
preclinical pipeline in oncology (including immuno-oncology agents)
and other therapeutic areas. In addition, its therapeutic platforms
are being leveraged through strategic partnerships with nine
biopharmaceutical companies. For additional information about
Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on
Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and “forward-looking information” within the meaning of
Canadian securities laws, or collectively, forward-looking
statements. Forward-looking statements in this news release
include, but are not limited to, statements that relate to
Zymeworks’ clinical and preclinical development of its product
candidates, related clinical trials and regulatory filings,
expected increases in research and development expenditures,
anticipated continued receipt of revenue from existing and future
partners, and other information that is not historical information.
When used herein, words such as “plan”, “expect”, “may”,
“continue”, “anticipate” 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. Zymeworks believes there is a reasonable basis for its
expectations and beliefs, but they are inherently uncertain.
Zymeworks may not realize its expectations, and its beliefs may not
prove correct. Actual results could differ materially from those
described or implied by such forward-looking statements as a result
of various factors, including, without limitation, market
conditions and the factors described under “Risk Factors” in
Zymeworks’ Annual Report on Form 10-K for its fiscal year ended
December 31, 2020 (a copy of which may be obtained at www.sec.gov
and www.sedar.com). Consequently, forward-looking statements should
be regarded solely as Zymeworks’ current plans, estimates and
beliefs. Investors should not place undue reliance on
forward-looking statements. Zymeworks cannot guarantee future
results, events, levels of activity, performance or achievements.
Zymeworks does not undertake and specifically declines any
obligation to update, republish, or revise any forward-looking
statements to reflect new information, future events or
circumstances or to reflect the occurrences of unanticipated
events, except as may be required by law.
ZYMEWORKS INC.
Consolidated Statements of Loss and
Comprehensive Loss
(Expressed in thousands of U.S. dollars
except share and per share data)
Three Months Ended December
31,
Year Ended December
31,
2020
2019
2020
2019
(unaudited)
(unaudited)
Revenue
Research and development
collaborations
$
15,680
$
1,877
$
38,951
$
29,544
Operating expenses:
Research and development
39,260
45,389
168,534
115,900
General and administrative
13,965
30,240
57,885
64,177
Impairment on acquired IPR&D
—
—
—
768
Total operating expenses
53,225
75,629
226,419
180,845
Loss from operations
(37,545
)
(73,752
)
(187,468
)
(151,301
)
Other (expense) income, net
(187
)
1,006
7,345
5,282
Loss before income taxes
(37,732
)
(72,746
)
(180,123
)
(146,019
)
Income tax (expense) recovery, net
(161
)
502
(429
)
582
Net loss and comprehensive loss
$
(37,893
)
$
(72,244
)
$
(180,552
)
$
(145,437
)
Net loss per common share:
Basic and diluted
(0.74
)
(1.66
)
(3.58
)
(3.83
)
Weighted-average common shares
outstanding:
Basic and diluted
51,136,942
43,597,446
50,382,497
38,022,014
ZYMEWORKS INC.
Selected Consolidated Balance Sheet
Data
(Expressed in thousands of U.S.
dollars)
December 31,
2020
December 31,
2019
Cash, cash equivalents, short-term
investments and certain long-term investments
$
451,557
$
298,904
Working capital
369,410
229,278
Total assets
538,376
368,205
Accumulated deficit
(471,261
)
(290,709
)
Total shareholders’ equity
409,922
245,681
NON-GAAP FINANCIAL MEASURES
In addition to reporting financial information in accordance
with U.S. generally accepted accounting principles (“GAAP”) in this
press release, Zymeworks is also reporting normalized expenses and
normalized loss per share, which are non-GAAP financial measures.
Normalized expenses and normalized loss per share are not defined
by GAAP and should not be considered as alternatives to net loss,
net loss per share or any other indicator of Zymeworks’ performance
required to be reported under GAAP. In addition, Zymeworks’
definitions of normalized expenses and normalized loss per share
may not be comparable to similarly titled non-GAAP measures
presented by other companies. Investors and others are encouraged
to review Zymeworks’ financial information in its entirety and not
rely on a single financial measure. As defined by Zymeworks,
normalized expenses represent total research and development
expenses and general and administrative expenses adjusted to
exclude non-cash stock-based compensation expenses for equity and
liability- classified equity instruments.
Normalized expenses are a non-GAAP measure that Zymeworks
believes is useful because it excludes those items that Zymeworks
believes are not representative of Zymeworks’ operating
performance.
GAAP to Non-GAAP
Reconciliations
(Expressed in thousands of U.S. dollars
except per share data)
(unaudited)
Three Months Ended December
31,
Year Ended December
31,
2020
2019
2020
2019
Research and development expenses
$
39,260
$
45,389
$
168,534
$
115,900
Stock based compensation for
equity-classified instruments
(3,619
)
(1,616
)
(12,299
)
(5,939
)
Stock based compensation for
liability-classified instruments
485
(5,501
)
6
(8,358
)
Normalized research and development
expenses (Non-GAAP basis)
$
36,126
$
38,272
$
156,241
$
101,603
General and administrative expenses
$
13,965
$
30,240
$
57,885
$
64,177
Stock based compensation for
equity-classified instruments
(3,942
)
(1,946
)
(14,645
)
(6,737
)
Stock based compensation for
liability-classified instruments
980
(18,562
)
(1,416
)
(27,470
)
Normalized general and administrative
expenses (Non-GAAP basis)
$
11,003
$
9,732
$
41,824
$
29,970
Net loss per common share – Basic and
diluted
$
(0.74
)
$
(1.66
)
$
(3.58
)
$
(3.83
)
Stock based compensation for
equity-classified instruments
0.15
0.08
0.53
0.33
Stock based compensation for
liability-classified instruments
(0.03
)
0.52
0.03
0.91
Normalized net loss per common share –
Basic and diluted (Non-GAAP basis)
$
(0.62
)
$
(1.06
)
$
(3.02
)
$
(2.59
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210224006001/en/
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com Tiffany Tolmie (604) 678-1388 ir@zymeworks.com
Media Inquiries: Mary Klem (604) 678-1388 media@zymeworks.com
Zymeworks (NYSE:ZYME)
Historical Stock Chart
From Aug 2024 to Sep 2024
Zymeworks (NYSE:ZYME)
Historical Stock Chart
From Sep 2023 to Sep 2024