Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq:
CHRS), today reported financial results for the quarter and full
year ended December 31, 2021 and highlighted recent achievement
of important milestones toward the Company’s key strategic
initiatives:
RECENT EXECUTION ON KEY STRATEGIC
INITIATIVESBuilding an innovative immuno-oncology
company:
- U.S. Food and Drug Administration (“FDA”) granted toripalimab
BLA priority review for nasopharyngeal carcinoma (“NPC”) and
assigned a target action date of April 30, 2022.
- Toripalimab in combination with chemotherapy demonstrated a
statistically significant overall survival benefit in prespecified
interim analysis of Phase 3 clinical trial in patients with
non-small cell lung cancer.
- Initiated process to exercise option to license JS006, a TIGIT
targeted antibody being evaluated in combination with toripalimab
in an ongoing Phase 1/2 clinical trial.
- Advancing internal immuno-oncology antibody into IND enabling
studies.
Diversifying and growing the commercial product
portfolio:
- FDA approved YUSIMRY™ (adalimumab-aqvh), a Humira® biosimilar,
on December 17, 2021.
- FDA accepted for review the BLA for CIMERLI™
(ranibizumab-ranq), a Lucentis® biosimilar, and assigned a target
action date in August 2022.
- UDENYCA® (pegfilgrastim-cbqv) on-body injector (“OBI”)
achieved both pharmacokinetic and pharmacodynamic bioequivalence in
randomized clinical trial, enabling prior approval supplement
filing with FDA in 2022; if approved, a UDENYCA OBI would compete
directly with Neulasta® Onpro® which retains approximately 50%
share of the overall pegfilgrastim market.
“We have made rapid progress transforming Coherus into an
innovative immuno-oncology company supported by income from a
diversified portfolio of FDA-approved products. In 2022, we expect
to launch two new products, if approved, including our first
immuno-oncology antibody, toripalimab, addressing an unmet need in
nasopharyngeal carcinoma, as well as CIMERLI. We also plan to
initiate a clinical trial in North America evaluating toripalimab
in combination with JS006, a TIGIT-targeted antibody,” said Denny
Lanfear, CEO of Coherus. “Looking ahead to 2023, we project
accelerating revenue growth with the planned launch of FDA-approved
YUSIMRY into the $17 billion Humira® market and the introduction of
the UDENYCA on-body injector, if approved, a new presentation that
would enable us to address the remaining $1.2 billion Neulasta®
Onpro® segment of the pegfilgrastim market where there is currently
no biosimilar competition.”
Fourth Quarter and Full Year 2021 Financial
Results
Net revenue, consisting of net sales of
UDENYCA, was $73.4 million for the fourth quarter of 2021 compared
to $110.4 million for the same period in 2020. Net revenue for 2021
was $326.6 million compared to $475.8 million for 2020. The
declines for the fourth quarter and full year 2021 were primarily
due to a decrease in the number of units of UDENYCA sold as well as
a decline in net realized price due to increased competition and
COVID-19 impacts.
Cost of goods sold (“COGS”) was $12.1 million
and $11.7 million during the three months ended December 31, 2021
and 2020, respectively, and $57.6 million and $37.7 million for the
full years 2021 and 2020, respectively. Through the first quarter
of 2021, Coherus sold inventory that was manufactured and expensed
prior to the approval of UDENYCA in late 2018. This inventory was
depleted in the first quarter of 2021, and since then COGS fully
reflects per unit acquisition cost of UDENYCA. UDENYCA COGS also
includes a mid single digit royalty on net sales payable through
the first half of 2024.
Research and development (“R&D”) expenses
for the fourth quarter of 2021 were $50.8 million, compared to
$44.6 million for the same period in 2020. The increase was
mainly due to higher regulatory and development costs in support of
the advancement of multiple pipeline product candidates. R&D
expense for 2021 was $363.1 million compared to $142.8 million for
2020. The increase of $220.3 million was primarily due to the
$136.0 million upfront license fee paid to Junshi Biosciences and
also due to costs incurred in the development of YUSIMRY,
toripalimab and additional presentations of UDENYCA.
Selling, general and administrative
(“SG&A”) expenses were $50.1 million for the fourth
quarter of 2021, compared to $37.7 million for the same period in
2020. The increase was driven primarily by increased
commercialization expense to support UDENYCA sales. For the full
year 2021, SG&A expenses were $169.7 million, compared to
$139.1 million for the prior year. The year-over-year increase is
primarily due to costs incurred in support of UDENYCA commercial
activities, as well as an increase in stock-based compensation
expense.
Cash and cash equivalents were $417.2 million
as of December 31, 2021, compared to $541.2 million as of December
31, 2020. During 2021, Coherus used $37.4 million in operating
activities and $138.4 million in investing activities, including
$136.0 million in an upfront payment to Junshi Biosciences. The
Company received net cash proceeds of $51.9 million from financing
activities related to the issuance of common stock to Junshi
Biosciences, as well as proceeds from the exercise of stock options
and from purchases under the employee stock purchase plan.
Net loss for the fourth quarter of 2021 was
$45.7 million, or $(0.60) per share on a diluted basis, compared to
net income of $9.7 million, or $0.12 per share on a diluted basis
for the same period in 2020. Net loss for 2021 was $287.1 million,
or $(3.81) per share on a diluted basis, compared to net income of
$132.2 million, or $1.62 per share on a diluted basis for 2020.
Non-GAAP net loss for the fourth quarter
of 2021 was $35.1 million, or $(0.46) per share on a
diluted basis, compared to non-GAAP income of $18.6 million,
or $0.23 per share on a diluted basis for the same period
in 2020. Non-GAAP net loss for 2021 was $88.5 million,
or $(1.17) per share on a diluted basis, compared to
non-GAAP income of $176.7 million, or $2.16 per
share on a diluted basis for 2020. See “Non-GAAP Financial
Measures” below for a discussion on how Coherus calculates non-GAAP
net income (loss) and a reconciliation to the most directly
comparable GAAP measures.
2022 Guidance
Coherus projects combined R&D and SG&A expenses in 2022
to be in the range of $415 million to $450 million, excluding a
potential $25 million milestone payable upon FDA approval of the
toripalimab BLA for nasopharyngeal carcinoma and the $35
million fee to exercise the option for the license to JS006, which
is expected to close in the first quarter of 2022. The projected
increase compared to 2021 is driven primarily by costs the Company
expects to incur with the anticipated launches of two new products,
toripalimab and CIMERLI, as well as manufacturing and development
costs for additional presentations of UDENYCA and for FDA-approved
YUSIMRY, which Coherus is planning to launch in 2023.
This financial guidance excludes the effects of any potential
future strategic acquisitions, collaborations or investments, the
exercise of rights or options related to collaboration programs,
and any other transactions or items not yet identified or
quantified. This guidance is subject to a number of risks and
uncertainties. See Forward-Looking Statements described in the
section below.
Conference Call InformationWhen: Thursday, Feb.
17, 2022, starting at 5 p.m. ETDial-in: (844) 452-6826 (Toll-Free
U.S. and Canada) or (765) 507-2587 (International)Conference ID:
3677018
Webcast: https://investors.coherus.com/upcoming-eventsPlease
dial-in 15 minutes early to ensure a timely connection to the
call.Fourth quarter and full year 2021 financial results are posted
on the Coherus website at https://investors.coherus.com/.
About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company building
an innovative immuno-oncology franchise funded with cash generated
by its diversified portfolio of FDA-approved therapeutics. In 2021,
Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the
United States and Canada. A biologics license application
for toripalimab for the treatment of metastatic or recurrent
nasopharyngeal carcinoma is currently under priority review by the
FDA, with a target action date of April 2022. Toripalimab is
also being evaluated in pivotal clinical trials for the treatment
of cancers of the lung, breast, liver, skin, kidney, stomach,
esophagus, and bladder.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of
Neulasta® in the United States, and expects to launch the
FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh)
in the United States in 2023. The FDA is currently
reviewing the biologics license application for CIMERLI™
(ranibizumab-ranq), a Lucentis® biosimilar, with a target action
date of August 2022. Coherus is also developing CHS-305, a
biosimilar of Avastin® (bevacizumab).
Forward-Looking Statements
Except for the historical information contained herein, the
matters set forth in this press release are forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995, including,
but not limited to, statements regarding Coherus’ ability to build
an innovative immuno-oncology franchise; Coherus’ ability to
generate cash; Coherus’ investment plans; Coherus’ expectations for
the launch date of YUSIMRY™ (adalimumab-aqvh); projections for
combined R&D and SG&A expenses in 2022; expectations for
launches of new products and payments of milestone expenses;
expectations of future accelerating revenue growth; estimations
about the size of the HUMIRA® market; and expectations of the
UDENYCA on-body injector to gain approval and address a large
market segment. Such forward-looking statements involve substantial
risks and uncertainties that could cause Coherus’ actual results,
performance or achievements to differ significantly from any future
results, performance or achievements expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the risks and uncertainties inherent in the clinical
drug development process; risks relating to the COVID-19 pandemic;
risks related to our existing and potential collaboration partners;
risks of the drug development position of Coherus’ competitors; the
risks and uncertainties of the regulatory approval process,
including the speed of regulatory review and the timing of Coherus’
regulatory filings; the risk of FDA review issues, including
accepting trial data from outside of the United States; the risk of
Coherus’ execution of its change in strategy from a focus on
biosimilars to a strategy using cash from biosimilars to fund an
immuno-oncology franchise; the risk that Coherus is unable to
complete commercial transactions and other matters that could
affect the availability or commercial potential of Coherus’ drug
candidates; and the risks and uncertainties of possible litigation.
All forward-looking statements contained in this press release
speak only as of the date of this press release. Coherus undertakes
no obligation to update or revise any forward-looking statements.
For a further description of the significant risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to Coherus’ business in general, see Coherus’ Annual
Report on Form 10-K for the year ended December 31, 2020,
filed with the Securities and Exchange
Commission on February 25, 2021, its subsequent Quarterly
Reports on Form 10-Q, including the sections therein captioned
“Risk Factors” and in other documents it files with
the Securities and Exchange Commission.
UDENYCA®, YUSIMRY™ and CIMERLI™, whether or not appearing in
large print or with the trademark symbol, are trademarks of
Coherus, its affiliates, related companies or its licensors or
joint venture partners, unless otherwise noted. Trademarks and
trade names of other companies appearing in this Press Release are,
to the knowledge of Coherus, the property of their respective
owners.
Neulasta® and Onpro® are registered trademarks of Amgen
Inc.Avastin® and Lucentis® are registered trademarks of Genentech,
Inc.Humira® is a registered trademark of AbbVie Inc.
Coherus BioSciences,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except share and per share
data)(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue |
|
$ |
73,371 |
|
|
$ |
110,419 |
|
|
$ |
326,551 |
|
|
$ |
475,824 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
12,104 |
|
|
|
11,673 |
|
|
|
57,591 |
|
|
|
37,667 |
|
Research and development |
|
|
50,762 |
|
|
|
44,628 |
|
|
|
363,105 |
|
|
|
142,759 |
|
Selling, general and administrative |
|
|
50,052 |
|
|
|
37,693 |
|
|
|
169,713 |
|
|
|
139,079 |
|
Total costs and expenses |
|
|
112,918 |
|
|
|
93,994 |
|
|
|
590,409 |
|
|
|
319,505 |
|
(Loss) income from
operations |
|
|
(39,547 |
) |
|
|
16,425 |
|
|
|
(263,858 |
) |
|
|
156,319 |
|
Interest expense |
|
|
(5,793 |
) |
|
|
(5,671 |
) |
|
|
(22,959 |
) |
|
|
(21,166 |
) |
Other (expense) income,
net |
|
|
(385 |
) |
|
|
6 |
|
|
|
(283 |
) |
|
|
554 |
|
Net (loss) income before
income taxes |
|
|
(45,725 |
) |
|
|
10,760 |
|
|
|
(287,100 |
) |
|
|
135,707 |
|
Income tax provision |
|
|
— |
|
|
|
1,052 |
|
|
|
— |
|
|
|
3,463 |
|
Net (loss) income |
|
$ |
(45,725 |
) |
|
$ |
9,708 |
|
|
$ |
(287,100 |
) |
|
$ |
132,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.60 |
) |
|
$ |
0.13 |
|
|
$ |
(3.81 |
) |
|
$ |
1.85 |
|
Diluted |
|
$ |
(0.60 |
) |
|
$ |
0.12 |
|
|
$ |
(3.81 |
) |
|
$ |
1.62 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of
shares used in computing net (loss) income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
76,828,940 |
|
|
|
72,223,970 |
|
|
|
75,449,632 |
|
|
|
71,411,705 |
|
Diluted |
|
|
76,828,940 |
|
|
|
87,713,218 |
|
|
|
75,449,632 |
|
|
|
83,491,898 |
|
Coherus BioSciences,
Inc.Condensed Consolidated Balance
Sheets(in thousands)(unaudited)
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
417,195 |
|
$ |
541,158 |
Trade receivables, net |
|
|
123,022 |
|
|
157,046 |
Inventory |
|
|
93,252 |
|
|
92,189 |
Other assets |
|
|
45,865 |
|
|
51,256 |
Total assets |
|
$ |
679,334 |
|
$ |
841,649 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Accrued rebates, fees and
reserve |
|
$ |
79,027 |
|
$ |
81,529 |
2022 Convertible Notes |
|
|
81,359 |
|
|
79,885 |
2022 Convertible Notes -
related parties |
|
|
27,120 |
|
|
26,628 |
2026 Convertible Notes |
|
|
224,288 |
|
|
223,029 |
2025 Term Loan |
|
|
75,513 |
|
|
74,481 |
Other liabilities |
|
|
94,301 |
|
|
75,123 |
Total stockholders'
equity |
|
|
97,726 |
|
|
280,974 |
Total liabilities and
stockholders’ equity |
|
$ |
679,334 |
|
$ |
841,649 |
Coherus BioSciences,
Inc.Condensed Consolidated Statements of Cash
Flows(in thousands)(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash at beginning of the
period |
|
$ |
360,980 |
|
|
$ |
292,905 |
|
|
$ |
541,598 |
|
|
$ |
177,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
operating activities |
|
|
(52,322 |
) |
|
|
33,124 |
|
|
|
(37,432 |
) |
|
|
154,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of investments in marketable securities |
|
|
(10,706 |
) |
|
|
— |
|
|
|
(182,485 |
) |
|
|
(273,845 |
) |
Proceeds from maturities of investments in marketable
securities |
|
|
36,992 |
|
|
|
211,000 |
|
|
|
99,692 |
|
|
|
274,000 |
|
Proceeds from sale of investments in marketable securities |
|
|
81,672 |
|
|
|
— |
|
|
|
81,672 |
|
|
|
— |
|
Upfront and milestone based license fee payments * |
|
|
— |
|
|
|
— |
|
|
|
(136,000 |
) |
|
|
(7,500 |
) |
Cash used in other investing activities |
|
|
(468 |
) |
|
|
(944 |
) |
|
|
(1,289 |
) |
|
|
(7,056 |
) |
Net cash provided by (used in)
investing activities |
|
|
107,490 |
|
|
|
210,056 |
|
|
|
(138,410 |
) |
|
|
(14,401 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds related to issuance of 2026 Convertible Notes, net of
issuance costs |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
222,156 |
|
Purchase of capped call options related to 2026 Convertible
Notes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(18,170 |
) |
Proceeds from issuance of common stock to Junshi Biosciences, net
of issuance costs |
|
|
— |
|
|
|
— |
|
|
|
40,903 |
|
|
|
— |
|
Proceeds from issuance of common stock upon exercise of stock
options |
|
|
673 |
|
|
|
4,414 |
|
|
|
10,399 |
|
|
|
17,428 |
|
Proceeds from purchase under the employee stock purchase plan |
|
|
1,017 |
|
|
|
1,244 |
|
|
|
3,002 |
|
|
|
3,801 |
|
Cash used in other financing activities |
|
|
(203 |
) |
|
|
(145 |
) |
|
|
(2,425 |
) |
|
|
(1,269 |
) |
Net cash provided by financing
activities |
|
|
1,487 |
|
|
|
5,513 |
|
|
|
51,879 |
|
|
|
223,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
|
56,655 |
|
|
|
248,693 |
|
|
|
(123,963 |
) |
|
|
363,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
restricted cash at end of the period |
|
$ |
417,635 |
|
|
$ |
541,598 |
|
|
$ |
417,635 |
|
|
$ |
541,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of cash, cash
equivalents, and restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
417,195 |
|
|
$ |
541,158 |
|
|
$ |
417,195 |
|
|
$ |
541,158 |
|
Restricted cash balance |
|
|
440 |
|
|
|
440 |
|
|
|
440 |
|
|
|
440 |
|
Cash, cash equivalents and
restricted cash |
|
$ |
417,635 |
|
|
$ |
541,598 |
|
|
$ |
417,635 |
|
|
$ |
541,598 |
|
* 2021 payments include license fees of $145.0 million pursuant
to the collaboration agreement with Junshi Biosciences paid in the
first quarter which was partially offset by a $9.0 million credit
related to the fair value of the discount for lack of marketability
on the common shares purchased under the stock purchase agreement
with Junshi Biosciences in the second quarter.
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with
GAAP, Coherus has also included in this press release non-GAAP net
income, and the related per share measures, which exclude from net
income, and the related per share measures, stock-based
compensation expense, upfront payments under its license
agreements, milestone payments under its license agreements for
periods prior to Q4 2021 only, the related income tax effect of
those non-GAAP adjustments and costs related to the termination of
the CHS-2020 development program that Coherus announced in February
2021. Starting in Q4 2021, Coherus no longer excludes milestone
payments from its non-GAAP financial information. Comparative prior
year amounts were not material and were not reclassified. These
non-GAAP financial measures are not prepared in accordance with
GAAP, do not serve as an alternative to GAAP and may be calculated
differently than similar non-GAAP financial information disclosed
by other companies. Coherus encourages investors to carefully
consider its results under GAAP, as well as its supplemental
non-GAAP financial information and the reconciliation between these
presentations set forth below, to more fully understand Coherus’
business.
Coherus believes that the presentation of these non-GAAP
financial measures provides useful supplementary information to,
and facilitates additional analysis by, investors. In particular,
Coherus believes that these non-GAAP financial measures, when
considered together with its financial information prepared in
accordance with GAAP, can enhance investors’ and analysts’ ability
to meaningfully compare Coherus’ results from period to period, and
to identify operating trends in Coherus’ business. Coherus also
regularly uses these non-GAAP financial measures internally to
understand, manage and evaluate its business and to make operating
decisions.
Coherus BioSciences,
Inc.Reconciliation of GAAP Net (Loss) Income to
Non-GAAP Net (Loss) Income(in thousands, except share and
per share data)(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) income |
|
$ |
(45,725 |
) |
|
$ |
9,708 |
|
|
$ |
(287,100 |
) |
|
$ |
132,244 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expense |
|
|
10,946 |
|
|
|
9,873 |
|
|
|
51,364 |
|
|
|
38,160 |
|
Upfront and milestone based license fee payments * |
|
|
— |
|
|
|
— |
|
|
|
136,000 |
|
|
|
7,500 |
|
Income tax effect of the above adjustments |
|
|
— |
|
|
|
(965 |
) |
|
|
— |
|
|
|
(1,165 |
) |
Costs related to termination of CHS-2020 development program |
|
|
(292 |
) |
|
|
— |
|
|
|
11,211 |
|
|
|
— |
|
Non-GAAP net (loss)
income |
|
$ |
(35,071 |
) |
|
$ |
18,616 |
|
|
$ |
(88,525 |
) |
|
$ |
176,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) income per
share, basic |
|
$ |
(0.60 |
) |
|
$ |
0.13 |
|
|
$ |
(3.81 |
) |
|
$ |
1.85 |
|
GAAP net (loss) income per
share, diluted |
|
$ |
(0.60 |
) |
|
$ |
0.12 |
|
|
$ |
(3.81 |
) |
|
$ |
1.62 |
|
Non-GAAP net (loss) income per
share, basic |
|
$ |
(0.46 |
) |
|
$ |
0.26 |
|
|
$ |
(1.17 |
) |
|
$ |
2.47 |
|
Non-GAAP net (loss) income per
share, diluted |
|
$ |
(0.46 |
) |
|
$ |
0.23 |
|
|
$ |
(1.17 |
) |
|
$ |
2.16 |
|
Shares used in computing basic
net (loss) income per share |
|
|
76,828,940 |
|
|
|
72,223,970 |
|
|
|
75,449,632 |
|
|
|
71,411,705 |
|
Shares used in computing
diluted net (loss) income per share |
|
|
76,828,940 |
|
|
|
87,713,218 |
|
|
|
75,449,632 |
|
|
|
83,491,898 |
|
* 2021 expense includes license fees of $145.0 million pursuant
to the collaboration agreement with Junshi Biosciences expensed in
the first quarter which was partially offset by a $9.0 million
credit related to the fair value of the discount for lack of
marketability on the common shares purchased under the stock
purchase agreement with Junshi Biosciences in the second
quarter.
ContactMcDavid StilwellChief Financial
OfficerCoherus BioSciences, Inc.IR@coherus.com
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