Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq:
CHRS), today reported financial results for the quarter ended March
31, 2022 and recent business highlights:
RECENT BUSINESS HIGHLIGHTS
- After receiving a complete response
letter (“CRL”) for the Biologics License Application (“BLA”) for
toripalimab, Coherus and partner Shanghai Junshi Biosciences Co.,
Ltd. (“Junshi Biosciences”) plan to resubmit the toripalimab BLA by
mid-summer with an expected six month review by the United States
Food and Drug Administration (“FDA”). The CRL requests a quality
process change that Coherus and Junshi Biosciences believe is
readily addressable.
- The FDA review of the BLA for
CIMERLI™ (ranibizumab-ranq), a Lucentis® biosimilar, is
advancing toward the target action date of August 2, 2022.
- The FDA granted Orphan Drug
Designation for toripalimab for the treatment of small cell lung
cancer.
- Two proprietary immuno-oncology
research programs have advanced to preclinical development:
CHS-1000, an ILT4-targeted antibody, and CHS-3318, a CCR8-targeted
antibody. Coherus expects to file an investigational new drug
application (“IND”) for CHS-1000 in 2023.
- Positive toripalimab clinical data
were presented and published:
- Final progression-free survival
(“PFS”) and interim overall survival (“OS”) data from the
JUPITER-02 trial evaluating toripalimab plus chemotherapy for
advanced nasopharyngeal carcinoma were presented at the annual
meeting of the American Association for Cancer Research in
April.
- Final PFS and interim OS data from
the CHOICE-01 trial evaluating toripalimab plus chemotherapy for
non-small cell lung cancer were presented at the March ASCO Plenary
Series.
- Final PFS and interim OS data from
the JUPITER-06 trial evaluating toripalimab plus chemotherapy for
first-line treatment of esophageal squamous cell carcinoma were
published in the March issue of Cancer Cell.
- Coherus has discontinued
development of CHS-305 (“IBI-305”), an Avastin® biosimilar
candidate, and is returning IBI-305 rights to Innovent Biologics
(Suzhou) Co., Ltd.
- Coherus is lowering by $20 million
the projected range for combined full year 2022 R&D and
SG&A expenses. See “2022 R&D and SG&A Expense
Guidance” section below.
“As we prepare for as many as four new product
launches in 2022 and 2023, we continue to make strong progress
transforming Coherus into an innovative immuno-oncology company
supported by revenues generated by our diversified commercial
portfolio of FDA-approved products,” said Denny Lanfear, Coherus’
CEO. “Following the recent late-cycle review meeting with the FDA,
we are finalizing our preparations to launch CIMERLI™ later this
year, if approved, into the $7 billion anti-VEGF ophthalmology
market in the United States. We expect to resubmit the toripalimab
BLA by mid-summer and are preparing for the commercial launch
directly upon approval. We continue to invest significantly in
YUSIMRY™ ahead of the planned launch in July 2023, as robust supply
availability is a key part of our market strategy. Our UDENYCA®
business continues to provide strong funding for our operations,
and we look forward to the potential launch next year of our
on-body injector presentation which, if approved, would allow us to
compete directly with Neulasta® Onpro®, a greater than $1 billion
market opportunity.”
FIRST QUARTER 2022 FINANCIAL RESULTS
Net revenue, consisting of net
sales of UDENYCA®, was $60.1 million and $83.0 million during the
three months ended March 31, 2022 and 2021, respectively. The
decline was primarily due to a decrease in the number of units of
UDENYCA® sold as well as a lower net realized price due to
increased competition.
Cost of goods sold (COGS) was
$9.4 million and $7.5 million during the three months ended March
31, 2022 and 2021, respectively. Until 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. UDENYCA® COGS also includes a mid-single
digit royalty on net sales payable through the first half of
2024.
Research and development
(R&D) expense for the three months ended March 31,
2022 was $82.9 million and included a $35 million option exercise
fee to Junshi Biosciences to license CHS-006, a clinical stage
TIGIT-targeted antibody, as well as development and manufacturing
costs for clinical and preclinical pipeline programs. For the same
period in 2021, R&D expense was $203.5 million and included a
$145 million upfront fee paid to Junshi Biosciences for the license
to rights to toripalimab for the United States and Canada, $11.5
million in costs related to the discontinuation of the CHS-2020
(Eylea® biosimilar) program, as well as development costs for
clinical and preclinical pipeline programs.
Selling, general and administrative
(SG&A) expense for the three months ended March
31, 2022 was $48.8 million compared to $39.4 million for the same
period in 2021. The increase was primarily driven by higher
commercialization expenses to support current UDENYCA® sales and in
preparation for multiple anticipated new product launches in 2022
and 2023, including CIMERLI™, toripalimab, YUSIMRY™, and the
on-body injector presentation of UDENYCA®.
Net loss for the first quarter
of 2022 was $96.1 million, or $(1.24) per share on a diluted basis,
compared to a net loss of $172.9 million, or $(2.37) per share on a
diluted basis for the same period in 2021.
Non-GAAP net loss for the
first quarter of 2022 was $77.0 million,
or $(1.00) per share on a diluted basis, compared to
non-GAAP net loss of $144.6 million, or $(1.98) per
share on a diluted basis for the same period in 2021. Beginning in
the first quarter of 2022, the Company no longer regularly excludes
upfront and milestone based license fee payments from its non-GAAP
financial information. To conform to this change, the prior period
non-GAAP financial information has been recast to include upfront
and milestone based license fee payments. See “Non-GAAP Financial
Measures” below for a discussion on how Coherus calculates non-GAAP
net loss and a reconciliation to the most directly comparable GAAP
measures.
Cash, cash equivalents and investments
in marketable securities were $325.7 million as of March
31, 2022, compared to $417.2 million at December 31, 2021.
2022 R&D and SG&A Expense Guidance
As a result of the discontinuation of the
CHS-305 development program and the delay of the toripalimab
commercial launch, Coherus is lowering the projected range for
combined full year 2022 R&D and SG&A expenses by $20
million to $395 million to $430 million. This range includes $55
million to $60 million of stock-based compensation expense and
excludes the $35 million license fee paid in the first quarter of
2022 for CHS-006 as well as a potential $25 million milestone
payable upon FDA approval of the toripalimab BLA for nasopharyngeal
carcinoma. This financial guidance also 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 circumstances
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 Information
When: Thursday, May 5th, 2022, starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (Toll-Free U.S. and Canada) or (765)
507-2587 (International)
Conference ID: 4142969
Please dial-in 15 minutes early to ensure a timely connection to
the call.
Webcast: https://investors.coherus.com/upcoming-eventsFirst
quarter 2022 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 commercial portfolio of
FDA-approved products. In 2021, Coherus in-licensed toripalimab, an
anti-PD-1 antibody, in the United States and Canada.
Coherus plans to resubmit a BLA for toripalimab for the treatment
of advanced nasopharyngeal carcinoma by mid-summer 2022.
Toripalimab is also being evaluated in pivotal clinical trials for
the treatment of rare and highly prevalent cancers.
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 biosimilar of Lucentis®, with a
target action date of August 2, 2022.
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 its immuno-oncology franchise to achieve a leading
market position; Coherus’ ability to generate cash; Coherus’
investment plans; Coherus' expectations for the launch dates of
YUSIMRY™, CIMERLI™, toripalimab and other products; Coherus’ plans
to resubmit the BLA for toripalimab and obtain FDA approval;
expectations for the timing of the submission of an IND for
CHS-1000; expectations for the timing of the FDA review of the BLA
for CIMERLI™ ; estimates of market opportunities for products
and product candidates and Coherus’expectations about R&D and
SG&A expense guidance for the full fiscal year 2022 and whether
it will be able to meet that guidance.
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, international aspects of Coherus’ business, the need to
schedule inspections in China and the timing of Coherus’ regulatory
filings; the risk of FDA review issues; the risk of Coherus’
execution of its change in strategy from a focus on biosimilars to
a strategy using cash from its portfolio 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’ Quarterly Report on Form 10-Q for
the quarter ended March 31, 2022, to be filed with the Securities
and Exchange Commission on or about May 5, 2022, including the
section therein captioned “Risk Factors” and in other documents
Coherus 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.
|
Coherus BioSciences, Inc.Condensed
Consolidated Statements of Operations(in thousands, except
share and per share data)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
Net revenue |
|
$ |
60,115 |
|
|
$ |
83,034 |
|
Costs and expenses: |
|
|
|
|
|
|
Cost of goods sold |
|
|
9,370 |
|
|
|
7,511 |
|
Research and development |
|
|
82,917 |
|
|
|
203,492 |
|
Selling, general and administrative |
|
|
48,753 |
|
|
|
39,391 |
|
Total costs and expenses |
|
|
141,040 |
|
|
|
250,394 |
|
Loss from operations |
|
|
(80,925 |
) |
|
|
(167,360 |
) |
Interest expense |
|
|
(8,969 |
) |
|
|
(5,648 |
) |
Loss on debt
extinguishment |
|
|
(6,222 |
) |
|
|
— |
|
Other income, net |
|
|
32 |
|
|
|
61 |
|
Net loss before income
taxes |
|
|
(96,084 |
) |
|
|
(172,947 |
) |
Income tax provision |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(96,084 |
) |
|
$ |
(172,947 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
|
$ |
(1.24 |
) |
|
$ |
(2.37 |
) |
|
|
|
|
|
|
|
Weighted-average number of
shares used in computing basic and diluted net loss per share |
|
|
77,253,699 |
|
|
|
72,832,953 |
|
|
|
|
|
|
|
|
|
|
Coherus BioSciences, Inc.Condensed
Consolidated Balance Sheets(in thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
325,680 |
|
$ |
417,195 |
Trade receivables, net |
|
|
117,039 |
|
|
123,022 |
Inventory |
|
|
96,372 |
|
|
93,252 |
Other assets |
|
|
54,296 |
|
|
45,865 |
Total assets |
|
$ |
593,387 |
|
$ |
679,334 |
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Accrued rebates, fees and
reserve |
|
$ |
71,894 |
|
$ |
79,027 |
Term loans |
|
|
195,849 |
|
|
75,513 |
Convertible notes |
|
|
224,607 |
|
|
332,767 |
Other liabilities |
|
|
88,474 |
|
|
94,301 |
Total stockholders'
equity |
|
|
12,563 |
|
|
97,726 |
Total liabilities and
stockholders’ equity |
|
$ |
593,387 |
|
$ |
679,334 |
Coherus BioSciences, Inc.Condensed
Consolidated Statements of Cash Flows(in
thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash at beginning of the
period |
|
$ |
417,635 |
|
|
$ |
541,598 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by
operating activities |
|
|
(54,045 |
) |
|
|
1,367 |
|
|
|
|
|
|
|
|
Purchases of investments in marketable securities |
|
|
— |
|
|
|
(140,330 |
) |
Upfront and option payments to Junshi Biosciences |
|
|
(35,000 |
) |
|
|
(145,000 |
) |
Cash used in other investing activities |
|
|
(615 |
) |
|
|
(145 |
) |
Net cash used in investing
activities |
|
|
(35,615 |
) |
|
|
(285,475 |
) |
|
|
|
|
|
|
|
Proceeds from 2027 Term Loans, net of debt discount & issuance
costs |
|
|
191,190 |
|
|
|
— |
|
Proceeds from issuance of common stock upon exercise of stock
options |
|
|
544 |
|
|
|
4,329 |
|
Taxes paid related to net share settlement of RSUs |
|
|
(2,658 |
) |
|
|
(1,730 |
) |
Repayment of 2022 Convertible Notes and premiums |
|
|
(109,000 |
) |
|
|
— |
|
Repayment of 2025 Term Loan, premiums and exit fees |
|
|
(81,750 |
) |
|
|
— |
|
Other financing activities |
|
|
(181 |
) |
|
|
(160 |
) |
Net cash (used in) provided by
financing activities |
|
|
(1,855 |
) |
|
|
2,439 |
|
|
|
|
|
|
|
|
Net decrease in cash, cash
equivalents and restricted cash |
|
|
(91,515 |
) |
|
|
(281,669 |
) |
|
|
|
|
|
|
|
Cash, cash equivalents and
restricted cash at end of the period |
|
$ |
326,120 |
|
|
$ |
259,929 |
|
|
|
|
|
|
|
|
Reconciliation of cash, cash
equivalents, and restricted cash |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
325,680 |
|
|
$ |
259,489 |
|
Restricted cash balance |
|
|
440 |
|
|
|
440 |
|
Cash, cash equivalents and
restricted cash |
|
$ |
326,120 |
|
|
$ |
259,929 |
|
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 loss, and the related per share measures,
which exclude from net loss, and the related per share measures,
stock-based compensation expense, loss on debt extinguishment and
costs related to the termination of the CHS-2020 development
program that Coherus announced in February 2021. Starting in the
first quarter of 2022, Coherus no longer excludes upfront and
milestone based license payments from its non-GAAP financial
information. Comparative prior year non-GAAP amounts were recast
and now include upfront and milestone based license fee payments.
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 to Non-GAAP Net Loss(1)(in
thousands, except share and per share data)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
GAAP net loss |
|
$ |
(96,084 |
) |
|
$ |
(172,947 |
) |
Adjustments: |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
12,879 |
|
|
|
16,884 |
|
Loss on debt extinguishment |
|
|
6,222 |
|
|
|
— |
|
Costs related to termination of CHS-2020 development program |
|
|
— |
|
|
|
11,503 |
|
Non-GAAP net loss |
|
$ |
(76,983 |
) |
|
$ |
(144,560 |
) |
|
|
|
|
|
|
|
GAAP net loss per share, basic
and diluted |
|
$ |
(1.24 |
) |
|
$ |
(2.37 |
) |
Non-GAAP net loss per share,
basic and diluted |
|
$ |
(1.00 |
) |
|
$ |
(1.98 |
) |
Shares used in computing basic
and diluted net loss per share |
|
|
77,253,699 |
|
|
|
72,832,953 |
|
(1) Beginning in the first quarter of 2022, the
Company no longer regularly excludes upfront and milestone based
license fee payments from its non-GAAP financial information. To
conform to this change, the prior period non-GAAP financial
information has been recast to include upfront and milestone based
license fee payments.
ContactMcDavid StilwellChief Financial
OfficerCoherus BioSciences, Inc.IR@coherus.com
Coherus BioSciences (NASDAQ:CHRS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Coherus BioSciences (NASDAQ:CHRS)
Historical Stock Chart
From Apr 2023 to Apr 2024