Coherus BioSciences, Inc. (Coherus or the Company,
Nasdaq: CHRS), today reported financial results for the quarter
ended September 30, 2024 and recent business highlights:
“Revenue growth was strong in the third quarter, with the
UDENYCA franchise increasing 30% compared to the second quarter,
and 100% over Q3 2023. LOQTORZI sales grew more than 50% compared
to the second quarter of 2024,” said Denny Lanfear, Coherus
Chairman and Chief Executive Officer. “Our sharpened focus on
oncology is delivering results. Third quarter 2024 revenues are now
comparable to Q3 2023, despite our divestitures, with higher gross
profit, lower operating expenses and lower interest expense.”
“We continue to make progress towards our long-term vision of
bringing innovative, next-generation therapies to extend cancer
patient survival. Our competitively positioned pipeline, in
combination with LOQTORZI, is advancing to plan in tumor types with
high unmet medical need and with robust supportive biology,”
continued Mr. Lanfear.
RECENT BUSINESS HIGHLIGHTS
UDENYCA® RESULTS
- UDENYCA net product sales were $66.1 million in Q3 2024, an
increase of 30% compared to $50.9 million in Q2 2024 and a 100%
increase compared to $33.0 million in Q3 2023.
- Q3 revenue was driven by a 54% increase in demand for ONBODY™
and a higher overall net selling price.
- In Q3, UDENYCA maintained its #2 position in the pegfilgrastim
class with 28% market share.
UDENYCA SUPPLY UPDATE
- Coherus’ third-party labeling and packaging contract
manufacturing organization (CMO) for UDENYCA has informed the
Company that production will resume this week, a few weeks later
than previously targeted and disclosed. Based on the production
schedule, the backlog of UDENYCA lots of approximately 120,000
units will be completed without further interruption or delay by
the end of the year.
- The Company has also made significant progress in its
previously announced efforts to diversify its labeling and
packaging resources. An additional final packaging and labeling CMO
has already started production testing and is expected to start
manufacturing saleable product by the end of 2024. Commercial
supply from that CMO is expected to commence in the first quarter
of 2025, subject to U.S. Food and Drug Administration (FDA)
authorization. Once the second facility is commercially
operational, the Company projects that its labeling and packaging
capacity will have doubled to over one million UDENYCA units
annually, consistent with the rest of its supply chain.
LOQTORZI® LAUNCH UPDATE
- LOQTORZI, the first and only FDA-approved treatment for
recurrent, locally advanced or metastatic nasopharyngeal carcinoma
(NPC), commercially launched across all lines of therapy on January
2, 2024.
- LOQTORZI net product sales were $5.8 million in Q3 2024, an
increase of 54% compared to $3.8 million in Q2 2024.
- The number of LOQTORZI treated patients grew by more than 60%
in Q3, with new patient uptake primarily in relapsed locally
advanced and 1L metastatic disease, the key driver of long-term
revenue growth.
- Since launch, nearly 80% of all National Comprehensive Cancer
Network (NCCN) institutions have written prescriptions for at least
one new patient.
ADVANCEMENT OF PROMISING IMMUNO-ONCOLOGY PIPELINE
- This quarter, the Company expects to open a Phase 2 randomized
study evaluating casdozokitug, an immune regulatory IL-27
antagonist in combination with toripalimab and bevacizumab for the
treatment of unresectable locally advanced or metastatic
hepatocellular carcinoma (HCC) in treatment-naive patients.
- The Company also anticipates final data from its Phase 2 trial
of casdozokitug combined with atezolizumab and bevacizumab in
first-line HCC in the first quarter of 2025. Coherus has received
FDA orphan drug status and fast track designation for casdozokitug
in HCC.
- A Phase 1 study evaluating CHS-114, a highly selective
cytolytic anti-CCR8 antibody, is ongoing. In the first half of
2025, Coherus expects to report Phase 1 data from expansion cohorts
evaluating CHS-114 as monotherapy and in combination with
toripalimab in patients with advanced/metastatic head and neck
squamous cell carcinoma (HNSCC).
- Coherus plans to initiate Phase 1b dose optimization studies of
CHS-114 in combination with toripalimab in patients with HNSCC and
gastric cancer in the first quarter of 2025, with initial data for
both studies expected in the first half of 2026.
THIRD QUARTER 2024 FINANCIAL RESULTS
Net revenue was $70.8 million during the three
months ended September 30, 2024, and included $66.1 million of net
sales of UDENYCA and $5.8 million of net sales of LOQTORZI. Net
revenue was $74.6 million during the three months ended September
30, 2023 and included $33.0 million in net sales of UDENYCA and
$41.4 million attributable to the Company’s divested products,
CIMERLI and YUSIMRY.
Net revenue was $212.8 million and $165.7 million for the nine
months ended September 30, 2024 and 2023, respectively. Total net
revenue attributable to the Company’s divested products, CIMERLI
and YUSIMRY, during the first nine months of 2024 and 2023 was
$34.5 million and $74.3 million, respectively. In addition, the
first nine months of 2024 included other revenue of $7.0 million
mainly comprising the $6.3 million up-front cash payment received
for the outlicense to Apotex, Inc. of the Canadian rights to
LOQTORZI on June 27, 2024.
Cost of goods sold (COGS) was $20.7 million and
$32.7 million during the three months ended September 30, 2024 and
2023, respectively, and $83.7 million and $74.4 million during the
nine months ended September 30, 2024 and 2023, respectively. The
decrease in COGS for the third quarter of 2024 compared to the same
period in the prior year was primarily due to $24.1 million of COGS
in the third quarter of 2023 related to CIMERLI and YUSIMRY, which
were divested during the first half of 2024, partially offset by a
$9.7 million increase in product costs driven by increased UDENYCA
volume.
The increase in COGS for the nine months ended September 30,
2024 compared to the same period in the prior year was primarily
due to a $27.8 million increase related to volumes driven by
UDENYCA and LOQTORZI, $4.5 million in connection with a CMO
contract change, and $2.5 million in LOQTORZI royalties. These
increases were partially offset by non-recurring COGS related to
products divested during the first half of 2024 mentioned
above.
Research and development (R&D) expenses
were $21.7 million and $25.6 million for the three months ended
September 30, 2024 and 2023, respectively, and $72.1 million and
$83.1 million for the nine months ended September 30, 2024 and
2023, respectively. The decreases were primarily due to savings
from reduced headcount and lower costs related to biosimilar
product divestitures, partially offset by costs for development of
casdozokitug and CHS-114.
Selling, general and administrative (SG&A)
expenses were $34.7 million and $48.2 million during the three
months ended September 30, 2024 and 2023, respectively, and $126.4
million and $142.5 million during the nine months ended September
30, 2024 and 2023, respectively. The declines in SG&A compared
to the prior year periods were driven primarily by lower headcount.
The decrease for the nine-month period was partially offset by the
net $6.8 million charge in the first quarter of 2024 associated
with the full write-off of the outlicense intangible asset and
associated release of the CVR liability related to NZV930, obtained
in the Surface Oncology, Inc. acquisition.
Interest expense was $5.4
million and $10.3 million during the three months ended September
30, 2024 and 2023, respectively, and $21.8 million and $29.9
million during the nine months ended September 30, 2024 and 2023,
respectively. The declines in both periods were primarily due to
prepaying $175.0 million of the principal amount due under the 2027
Term Loans on April 1, 2024 and the remaining $75.0 million
principal amount on May 8, 2024, partially offset by interest on
the senior secured term loan facility of up to $38.7 million
and the revenue participation right purchase and sale agreement,
both commencing May 8, 2024.
Gain on sale transactions, net
was $176.6 million for the nine months ended September 30, 2024 and
included a $153.8 million gain on the divestiture of our CIMERLI
ophthalmology franchise, which closed during the first quarter of
2024, and a $22.9 million gain on the divestiture of our YUSIMRY
immunology franchise, which closed during the second quarter of
2024. There was no gain on sale transactions in the nine months
ended September 30, 2023.
Net loss for the third quarter of 2024 was
$10.8 million, or $(0.09) per share on a diluted basis, compared to
a net loss of $39.6 million, or $(0.41) per share on a diluted
basis for the same period in 2023. Net income for the nine months
ended September 30, 2024 was $79.2 million, or $0.65 per share on a
diluted basis, compared to a net loss of $158.2 million, or $(1.79)
per share on a diluted basis for nine months ended September 30,
2023.
Non-GAAP net loss for the third quarter of 2024
was $1.7 million, or $(0.01) per share on a diluted basis, compared
to $26.9 million, or $(0.27) per share for the same period in 2023.
Non-GAAP net loss for the nine months ended September 30, 2024 was
$53.8 million, or $(0.47) per share on a diluted basis, compared to
$117.3 million, or $(1.33) per share for the same period in 2023.
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 $97.7 million as of September 30, 2024,
compared to $117.7 million as of December 31, 2023.
2024 R&D and SG&A Expense
Guidance Coherus projects combined R&D and
SG&A expenses for 2024 to be in the range of $250 to $260
million. This guidance includes approximately $30 million of
stock-based compensation expense and excludes the effects of
acquisitions, collaborations, investments, divestitures including
expenses incurred on behalf of and reimbursed by Sandoz Inc. and
Hong Kong King-Friend Industrial Company Ltd. to satisfy Coherus’
obligations under the transition services agreements with those
entities, restructuring, 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: Wednesday, November 6, 2024, starting at 5:00 p.m. Eastern
Time
To access the conference call, please pre-register through the
following link to receive dial-in information and a personal PIN to
access the live call:
https://register.vevent.com/register/BI6dfb4eba6e9a4322a716df863233a53fPlease
dial in 15 minutes early to ensure a timely connection to the
call.
Webcast: https://edge.media-server.com/mmc/p/fgk872yp
An archived webcast will be available on the “Investors” section
of the Coherus website at
https://investors.coherus.com/events-presentations.
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused
on the research, development and commercialization of innovative
immunotherapies to treat cancer. Coherus is developing an
innovative immuno-oncology pipeline that is expected to be
synergistic with its proven commercial capabilities in
oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody
immunotherapy candidates focused on enhancing the innate and
adaptive immune responses to enable a robust immunologic response
and enhance outcomes for patients with cancer. Casdozokitug is a
novel anti-IL-27 antibody currently being evaluated in two ongoing
clinical studies: a Phase 1/2 study in advanced solid tumors and a
Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly
selective, competitively positioned, ADCC-enhanced anti-CCR8
antibody currently in a Phase 1 study as a monotherapy in patients
with advanced solid tumors and in combination with toripalimab in
patients with head and neck cancer. CHS-1000 is a novel humanized
Fc-modified IgG1 monoclonal antibody specifically targeting ILT4
(LILRB2). Our IND for CHS-1000 was allowed to proceed by the FDA in
the second quarter of 2024 and proceeding to the first-in-human
clinical study is subject to further evaluation in our portfolio
prioritization process.
Coherus markets LOQTORZI® (toripalimab-tpzi), a novel
next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv),
a biosimilar of Neulasta®.
Neulasta® is a registered trademark of Amgen Inc.
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’ expectations
about identifying synergies between its I-O pipeline and its
commercial operations; Coherus’ expected timing for initiating
studies and reporting clinical data for its pipeline product
candidates; Coherus’ future projections for R&D and SG&A
expenses; Coherus’ expectations about long term revenue growth;
Coherus’ expected future packaging and labeling capacity for
UDENYCA and Coherus’ expectations about the timing for the end of
its UDENYCA supply interruption, including timing for resumption of
UDENYCA production from its labeling and packaging CMO, timing for
the backlog of UDENYCA lots to be completed by its labeling and
packaging CMO and projections for the number of units to be
completed, the expected timing for its additional packaging and
labeling CMO to manufacture final saleable product, receive FDA
authorization for UDENYCA production and commence commercial
supply.
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 related to Coherus’ existing and
potential collaboration partners; risks of Coherus’ reliance on
third-parties; the risks and uncertainties related to manufacturing
and supply of Coherus’ products, the risks and uncertainties of the
regulatory approval process, including the speed of regulatory
review and the timing of Coherus’ regulatory filings; 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 fiscal quarter ended September 30, 2024 filed with the
Securities and Exchange Commission on or about the date of this
press release, including the section therein captioned “Risk
Factors” and in other documents Coherus files with the Securities
and Exchange Commission. Coherus’ results for the fiscal quarter
ended September 30, 2024 are not necessarily indicative of its
operating results for any future periods.
UDENYCA®, UDENYCA® ONBODY™, and LOQTORZI®, 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 Contact Information:For Investors:Jodi
SieversVP, Investor Relations & Corporate
CommunicationsIR@coherus.com
For Media:Argot Partners(212)
600-1902coherus@argotpartners.com
Coherus BioSciences, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share data) |
(unaudited) |
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Net revenue |
$ |
70,774 |
|
|
$ |
74,568 |
|
|
$ |
212,816 |
|
|
$ |
165,720 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
20,741 |
|
|
|
32,703 |
|
|
|
83,695 |
|
|
|
74,425 |
|
Research and development |
|
21,676 |
|
|
|
25,647 |
|
|
|
72,101 |
|
|
|
83,068 |
|
Selling, general and administrative |
|
34,744 |
|
|
|
48,224 |
|
|
|
126,441 |
|
|
|
142,521 |
|
Total costs and expenses |
|
77,161 |
|
|
|
106,574 |
|
|
|
282,237 |
|
|
|
300,014 |
|
Loss from operations |
|
(6,387 |
) |
|
|
(32,006 |
) |
|
|
(69,421 |
) |
|
|
(134,294 |
) |
Interest expense |
|
(5,362 |
) |
|
|
(10,268 |
) |
|
|
(21,812 |
) |
|
|
(29,923 |
) |
Gain (loss) on Sale
Transactions, net |
|
(1,086 |
) |
|
|
— |
|
|
|
176,646 |
|
|
|
— |
|
Loss on debt
extinguishment |
|
— |
|
|
|
— |
|
|
|
(12,630 |
) |
|
|
— |
|
Other income (expense),
net |
|
2,084 |
|
|
|
2,253 |
|
|
|
6,420 |
|
|
|
5,598 |
|
Income (loss) before income
taxes |
|
(10,751 |
) |
|
|
(40,021 |
) |
|
|
79,203 |
|
|
|
(158,619 |
) |
Income tax provision |
|
— |
|
|
|
(380 |
) |
|
|
— |
|
|
|
(380 |
) |
Net income (loss) |
$ |
(10,751 |
) |
|
$ |
(39,641 |
) |
|
$ |
79,203 |
|
|
$ |
(158,239 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.09 |
) |
|
$ |
(0.41 |
) |
|
$ |
0.69 |
|
|
$ |
(1.79 |
) |
Diluted |
$ |
(0.09 |
) |
|
$ |
(0.41 |
) |
|
$ |
0.65 |
|
|
$ |
(1.79 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of
shares used in computing net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
115,210,091 |
|
|
|
97,738,509 |
|
|
|
114,263,256 |
|
|
|
88,277,936 |
|
Diluted |
|
115,210,091 |
|
|
|
97,738,509 |
|
|
|
126,563,551 |
|
|
|
88,277,936 |
|
Coherus BioSciences, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands) |
(unaudited) |
|
|
September 30, |
|
December 31, |
|
2024 |
|
2023 |
Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
97,690 |
|
|
$ |
102,891 |
|
Investments in marketable
securities |
|
— |
|
|
|
14,857 |
|
Trade receivables, net |
|
167,559 |
|
|
|
260,522 |
|
TSA receivables, net |
|
31,241 |
|
|
|
— |
|
Inventory |
|
119,015 |
|
|
|
130,100 |
|
Intangible assets, net |
|
54,313 |
|
|
|
71,673 |
|
Other assets |
|
35,182 |
|
|
|
49,561 |
|
Total assets |
$ |
505,000 |
|
|
$ |
629,604 |
|
|
|
|
|
|
|
Liabilities and
Stockholders’ Deficit |
|
|
|
|
|
Accrued rebates, fees and
reserve |
$ |
163,315 |
|
|
$ |
169,645 |
|
TSA payables and other accrued
liabilities |
|
33,637 |
|
|
|
— |
|
Term loans |
|
36,618 |
|
|
|
246,481 |
|
Convertible notes |
|
227,891 |
|
|
|
226,888 |
|
Other liabilities |
|
131,512 |
|
|
|
180,015 |
|
Total stockholders'
deficit |
|
(87,973 |
) |
|
|
(193,425 |
) |
Total liabilities and
stockholders’ deficit |
$ |
505,000 |
|
|
$ |
629,604 |
|
Coherus BioSciences, Inc. |
Condensed Consolidated Statements of Cash
Flows |
(in thousands) |
(unaudited) |
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Cash, cash equivalents and restricted cash at beginning of the
period |
$ |
159,692 |
|
|
$ |
73,360 |
|
|
$ |
103,343 |
|
|
$ |
63,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities |
|
(62,016 |
) |
|
|
(54,300 |
) |
|
|
(49,048 |
) |
|
|
(161,947 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from maturities of investments in marketable
securities |
|
— |
|
|
|
43,398 |
|
|
|
6,200 |
|
|
|
108,148 |
|
Proceeds from sale of investments in marketable securities |
|
— |
|
|
|
— |
|
|
|
8,688 |
|
|
|
13,282 |
|
Cash and cash equivalents acquired from Surface Acquisition |
|
— |
|
|
|
6,997 |
|
|
|
— |
|
|
|
6,997 |
|
Cash received from CIMERLI sale |
|
— |
|
|
|
— |
|
|
|
187,823 |
|
|
|
— |
|
Cash received from YUSIMRY sale |
|
— |
|
|
|
— |
|
|
|
40,000 |
|
|
|
— |
|
Milestone based license fee payment to Junshi Biosciences |
|
— |
|
|
|
— |
|
|
|
(12,500 |
) |
|
|
— |
|
Purchases of investments in marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(19,507 |
) |
Other investing activities, net |
|
444 |
|
|
|
151 |
|
|
|
652 |
|
|
|
517 |
|
Net cash provided by investing
activities |
|
444 |
|
|
|
50,546 |
|
|
|
230,863 |
|
|
|
109,437 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from 2029 Term Loan, net of debt discount & issuance
costs |
|
(141 |
) |
|
|
— |
|
|
|
36,979 |
|
|
|
— |
|
Proceeds from Revenue Purchase and Sale Agreement, net of issuance
costs |
|
(9 |
) |
|
|
— |
|
|
|
36,486 |
|
|
|
— |
|
Proceeds from issuance of common stock under ATM Offering, net of
issuance costs |
|
— |
|
|
|
11,437 |
|
|
|
1,455 |
|
|
|
18,198 |
|
Proceeds from issuance of common stock under Public Offering, net
of issuance costs |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
53,625 |
|
Proceeds from issuance of common stock upon exercise of stock
options |
|
— |
|
|
|
53 |
|
|
|
291 |
|
|
|
170 |
|
Proceeds from purchase under the employee stock purchase plan |
|
— |
|
|
|
— |
|
|
|
685 |
|
|
|
1,337 |
|
Repayment of 2027 Term Loans, premiums and fees |
|
— |
|
|
|
— |
|
|
|
(260,387 |
) |
|
|
— |
|
Taxes paid related to net share settlement |
|
(10 |
) |
|
|
(175 |
) |
|
|
(2,466 |
) |
|
|
(3,261 |
) |
Other financing activities |
|
(7 |
) |
|
|
(210 |
) |
|
|
(248 |
) |
|
|
(835 |
) |
Net cash (used in) provided by
financing activities |
|
(167 |
) |
|
|
11,105 |
|
|
|
(187,205 |
) |
|
|
69,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in
cash, cash equivalents and restricted cash |
|
(61,739 |
) |
|
|
7,351 |
|
|
|
(5,390 |
) |
|
|
16,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
restricted cash at end of the period |
$ |
97,953 |
|
|
$ |
80,711 |
|
|
$ |
97,953 |
|
|
$ |
80,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of cash, cash
equivalents, and restricted cash |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
97,690 |
|
|
$ |
80,259 |
|
|
$ |
97,690 |
|
|
$ |
80,259 |
|
Restricted cash balance |
|
263 |
|
|
|
452 |
|
|
|
263 |
|
|
|
452 |
|
Cash, cash equivalents and
restricted cash |
$ |
97,953 |
|
|
$ |
80,711 |
|
|
$ |
97,953 |
|
|
$ |
80,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 income (loss), and the related per share
measures, stock-based compensation expense, certain
acquisition-related expenses, amortization of intangible assets,
gain (loss) on divestiture, impairments of intangible assets,
contingent consideration, loss on debt extinguishment and
restructuring charges related to our reduction in workforce. 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 supplemental
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 Income (Loss) to Non-GAAP Net
Loss |
(in thousands, except share and per share data) |
(unaudited) |
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
GAAP net income (loss) |
$ |
(10,751 |
) |
|
$ |
(39,641 |
) |
|
$ |
79,203 |
|
|
$ |
(158,239 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense(1) |
|
6,868 |
|
|
|
9,954 |
|
|
|
21,418 |
|
|
|
31,364 |
|
Loss (gain) on Sale Transactions, net |
|
1,086 |
|
|
|
— |
|
|
|
(176,646 |
) |
|
|
— |
|
Loss on debt extinguishment |
|
— |
|
|
|
— |
|
|
|
12,630 |
|
|
|
— |
|
Impairment of out-license asset and remeasurement of CVR liability,
net |
|
— |
|
|
|
— |
|
|
|
6,772 |
|
|
|
— |
|
Restructuring charges related to reduction in workforce(1) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
4,876 |
|
Acquisition-related costs, including amortization of
intangibles(2) |
|
1,142 |
|
|
|
2,830 |
|
|
|
2,776 |
|
|
|
4,691 |
|
Non-GAAP net loss |
$ |
(1,655 |
) |
|
$ |
(26,857 |
) |
|
$ |
(53,847 |
) |
|
$ |
(117,308 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share,
basic |
$ |
(0.09 |
) |
|
$ |
(0.41 |
) |
|
$ |
0.69 |
|
|
$ |
(1.79 |
) |
Net income (loss) per share,
diluted |
$ |
(0.09 |
) |
|
$ |
(0.41 |
) |
|
$ |
0.65 |
|
|
$ |
(1.79 |
) |
Shares used in computing basic
net income (loss) per share |
|
115,210,091 |
|
|
|
97,738,509 |
|
|
|
114,263,256 |
|
|
|
88,277,936 |
|
Shares used in computing
diluted net income (loss) per share |
|
115,210,091 |
|
|
|
97,738,509 |
|
|
|
126,563,551 |
|
|
|
88,277,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.01 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.33 |
) |
Shares used in computing basic
and diluted net loss per share |
|
115,210,091 |
|
|
|
97,738,509 |
|
|
|
114,263,256 |
|
|
|
88,277,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) In the nine months ended September 30, 2023,
stock-based compensation of $1.0 million was classified within
Restructuring charges related to reduction in workforce.
(2) Beginning in the third quarter of 2023, the
Company began excluding acquisition-related costs in its non-GAAP
financial information. To conform to this change, $1.9 million of
acquisition-related costs, including amortization of intangibles
incurred during the quarter ended June 30, 2023 has been excluded
from SG&A expense for the nine months ended September 30,
2023.
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