Full-Year and Fourth Quarter 2024 Product
Revenues Increased 15% and 9%, respectively, from Prior Year
Periods
Fourth straight quarter of positive operating
cash flows
Reiterating Full-Year 2025 Product Revenue
Guidance Range of $194 – $200 million
Cerus Corporation (Nasdaq: CERS) today announced financial
results for its full year and fourth quarter ended December 31,
2024.
Recent highlights include:
- Total revenue for full-year 2024 and fourth quarter 2024 was
comprised of (in thousands, except %):
Three Months Ended
Twelve Months Ended
December 31,
Change
December 31,
Change
Unaudited
Unaudited
2024
2023
$
%
2024
2023
$
%
Product Revenue
$
50,809
$
46,768
$
4,041
9
%
$
180,270
$
156,367
$
23,903
15
%
Government Contract Revenue
5,942
6,574
(632
)
-10
%
21,051
30,430
(9,379
)
-31
%
Total Revenue
$
56,751
$
53,342
$
3,409
6
%
$
201,321
$
186,797
$
14,524
8
%
- The Company is reiterating its full-year 2025 annual product
revenue guidance range of $194 million to $200 million, which
includes $12 million to $15 million for INTERCEPT Fibrinogen
Complex (IFC).
- Continued financial execution for full year and Q4 2024:
- Over 40% improvement in 2024 GAAP net loss attributable to
Cerus Corporation to $20.9 million from $37.5 million for the
previous year.
- Achieved positive non-GAAP adjusted EBITDA of $5.7 million for
2024, outperforming against the stated objective of break-even
adjusted EBITDA.
- Generated positive operating cash flows for the fourth straight
quarter of 2024 bringing year-to-date positive operating cash flows
to $11.4 million, an improvement of almost $55.0 million from
2023.
“Our exceptional fourth quarter performance capped a year of
significant growth for Cerus, positioning us well for 2025 and
beyond. INTERCEPT double-digit product revenue growth in 2024
reflects the continued momentum of our platelets business and
rising clinical demand for our IFC product, underscoring the
expanding impact of our pathogen inactivation technology in
transfusion medicine,” stated William “Obi” Greenman, Cerus’
president and chief executive officer.
“Beyond our top-line growth, we delivered robust financial
results, narrowing our GAAP net loss and achieving our communicated
target of positive non-GAAP adjusted EBITDA for 2024 - key metrics
we remain committed to improving. After achieving positive adjusted
EBITDA in 2024 and projecting growth based on our 2025 product
revenue guidance, we anticipate leveraging the inherent strengths
of our business for continued financial improvement. With a
multi-billion dollar total addressable market for existing approved
products, enduring customer trust and a first-mover advantage, we
believe we are setting new standards in blood safety and are
well-positioned for continued success.”
Revenue
Product revenue for the full year 2024 was $180.3 million, up
$23.9 million from the prior year, representing 15% growth. IFC
product revenue for full-year 2024 was $9.2 million, up from $6.5
million from the prior year, representing 42% growth. Product
revenue for the fourth quarter of 2024 was $50.8 million, compared
to $46.8 million for the prior year period. This year-over-year
increase of 9% was driven primarily by growth in the Company’s
platelets business, in both EMEA and North America. Fourth quarter
product revenue included sales of IFC, which were $3.0 million, up
from $2.3 million during the prior year period.
Government contract revenue for the full year 2024 was $21.1
million, compared to $30.4 million for the prior year. Fourth
quarter 2024 government contract revenue was $5.9 million, compared
to $6.6 million during the prior year period. The Company’s
government contract revenue was comprised of funding associated
with research and development (R&D) activities related to the
INTERCEPT Blood System for RBCs as well as efforts related to the
development of next-generation pathogen reduction technology to
treat whole blood and development of a lyophilized IFC. Reported
government contract revenue during the fourth quarter of 2024
decreased versus the prior year period, primarily due to completion
of the U.S. Phase 3 ReCePI clinical trial for INTERCEPT RBCs.
Product Gross Profit & Margin
Full-year 2024 product gross profit was $99.5 million, compared
to $86.4 million for the prior year. Product gross margin for the
full year 2024 was relatively stable year-over-year at 55.2%
compared to 55.3% for the prior year.
Product gross profit for the fourth quarter of 2024 was $27.4
million, increasing by over 5% over the prior year period. Product
gross margin for the fourth quarter of 2024 was 53.9%, compared to
55.5% for the prior year period. Product gross margin for the
fourth quarter of 2024 decreased versus the prior period, primarily
driven by the strengthening U.S. dollar and elevated freight costs
driven by measures taken to serve the growing demand for our
products in the U.S.
Operating Expenses
Total operating expenses for the year declined over 8% from 2023
levels and were $134.8 million in 2024 compared to $146.9 million
in the prior year. The decrease in operating expenses for the year
are attributable to the impact of the Company’s 2023 restructuring
program, the successful completion and outcome of the ReCePI Phase
3 clinical trial for the red blood cell program offset by higher
costs for the company’s next generation illumination device and the
increase in enrollment at sites supporting the RedeS Phase 3
clinical trial for red blood cells. For the fourth quarter of 2024,
total operating expenses were $34.8 million, compared to $31.6
million for the same period of the prior year, reflecting an
increase of 10%.
R&D expenses for the full year 2024 were down 13% to $58.9
million from $67.6 million in the prior year. For the fourth
quarter of 2024, R&D expenses were $15.4 million, compared to
$14.3 million for the prior year period. The increase in R&D
expenses was related to RedeS site ramp enrollment, activities
covered under the new U.S. Biomedical Advanced Research and
Development Authority (BARDA) contract and submission for CE Mark
approval for the Company’s next generation illuminator.
Full-year 2024 SG&A expenses were $75.9 million compared to
$75.5 million for the prior year. SG&A expenses for the fourth
quarter of 2024 were $19.3 million, compared to $17.3 million for
the prior year period. The primary reason for the increase in
SG&A expenses was non-cash stock-based compensation, offset by
the impact of the Company’s 2023 restructuring. The Company expects
to continue seeing significant leverage in SG&A expenses with
costs rising modestly relative to the expected revenue growth.
Net Loss Attributable to Cerus Corporation
Net loss attributable to Cerus Corporation for full-year 2024
was $20.9 million, compared to a net loss attributable to Cerus
Corporation of $37.5 million for full-year 2023. Net loss
attributable to Cerus Corporation for the fourth quarter of 2024
was $2.5 million, or $0.01 per basic and diluted share, compared to
a net loss attributable to Cerus Corporation of $1.3 million, or
$0.01 per basic and diluted share, for the fourth quarter of
2023.
Non-GAAP Adjusted EBITDA
Importantly, the Company not only outperformed on the top-line
but also achieved its other stated 2024 goal of reaching positive
non-GAAP adjusted EBITDA, which was a positive $5.7 million for the
full-year 2024, compared to a loss of $10.7 million for the
full-year 2023. Non-GAAP adjusted EBITDA for the fourth quarter of
2024 was $3.3 million, compared to $4.7 million for the fourth
quarter of 2023. The Company expects improvements to GAAP net loss
attributable to Cerus Corporation for the full-year 2025 and to
maintain a positive non-GAAP adjusted EBITDA for the full-year
2025. For additional information, please see definitions and the
reconciliation of this non-GAAP measure to net loss attributable to
Cerus Corporation accompanying this release.
Balance Sheet & Cash Flows
At December 31, 2024, the Company had cash and cash equivalents
and short-term investments of $80.5 million, compared to $75.6
million at September 30, 2024, and $65.9 million at December 31,
2023.
As of December 31, 2024, the Company had $65.0 million
outstanding on its term loan and $19.3 million drawn on its
revolving credit facility. The Company’s revolving line of credit
allows for an additional $15.7 million as of December 31, 2024,
which is dependent on eligible assets supporting the borrowing
base.
For full-year 2024, the Company generated positive operating
cash flows of $11.4 million compared to cash used from operations
during 2023 of $43.2 million, an improvement of almost $55.0
million. Similarly, for the fourth quarter of 2024, the Company
generated positive cash flows of $4.9 million from operations
compared to cash used in operations of $15.2 million during the
prior year period.
Reiterating 2025 Product Revenue Guidance
The Company expects full-year 2025 product revenue will be in
the range of $194 million to $200 million, reflecting 8% to 11%
growth from 2024. Included in this range is full-year 2025 IFC
revenue guidance between $12 million to $15 million. Product
revenue growth is expected to be fueled by continued penetration
with U.S. platelet customers, geographic expansion of the INTERCEPT
platelet business as well as increasing uptake of IFC in the
U.S.
Quarterly Conference Call
The Company will host a conference call at 4:30 P.M. EST this
afternoon, during which management will discuss the Company’s
financial results and provide a general business overview and
outlook. To listen to the live webcast, please visit the Investor
Relations page of the Cerus website at http://www.cerus.com/ir.
A replay will be available on Cerus’ website approximately three
hours after the call through March 6, 2025.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Headquartered in Concord, California, the Company
develops and supplies vital technologies and pathogen-protected
blood components to blood centers, hospitals, and ultimately
patients who rely on safe blood. The INTERCEPT Blood System for
platelets and plasma is available globally and remains the only
pathogen reduction system with both CE mark and FDA approval for
these two blood components. In the U.S., the INTERCEPT Blood System
for Cryoprecipitation is approved for the production of Pathogen
Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to
as INTERCEPT Fibrinogen Complex), a therapeutic product for the
treatment and control of bleeding, including massive hemorrhage,
associated with fibrinogen deficiency. The INTERCEPT Blood System
for RBCs is in late-stage clinical development. For more
information about Cerus, visit www.cerus.com and follow us on
LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
Forward- Looking Statements
Except for the historical statements contained herein, this
press release contains forward-looking statements concerning Cerus’
products, prospects and expected results, including statements
relating to: Cerus’ 2025 annual product revenue guidance and
related projected growth; Cerus’ belief that it is setting new
standards in blood safety and is well-positioned for continued
success; Cerus’ market opportunity, including its estimated total
addressable market; Cerus’ expectation for continued financial
improvement; Cerus’ expectation to continue seeing significant
leverage in SG&A expenses with costs rising modestly relative
to the expected revenue growth; Cerus’ expectations for
improvements to GAAP net loss attributable to Cerus Corporation for
the full-year 2025 and that it will maintain a positive non-GAAP
adjusted EBITDA for the full-year 2025; Cerus continuing to have
access to $15.7 million under its revolving line of credit; and
other statements that are not historical fact. Actual results could
differ materially from these forward-looking statements as a result
of certain factors, including, without limitation: risks associated
with the commercialization and market acceptance of, and customer
demand for, the INTERCEPT Blood System, including the risks that
Cerus may not (a) meet its 2025 annual product revenue guidance,
(b) effectively continue to launch and commercialize the INTERCEPT
Blood System for Cryoprecipitation, (c) grow sales globally,
including in its U.S. and European markets, and/or realize expected
revenue contribution resulting from its U.S. and European market
agreements, (d) realize meaningful and/or increasing revenue
contributions from U.S. customers in the near term or at all,
particularly since Cerus cannot guarantee the volume or timing of
commercial purchases, if any, that its U.S. customers may make
under Cerus’ commercial agreements with these customers, (e)
effectively expand its commercialization activities into additional
geographies and/or (f) realize any revenue contribution from new
product offerings, including extended shelf life platelet
processing sets, or its pipeline product candidates, whether due to
Cerus’ inability to obtain regulatory approval of its pipeline
programs, or otherwise; risks associated with macroeconomic
developments, including ongoing military conflict in Ukraine, new
or increased tariffs and escalating trade tensions and the
resulting global economic and financial disruptions, and the
current and potential future negative impacts to Cerus’ business
operations and financial results; risks associated with Cerus’ lack
of longer-term commercialization experience with the INTERCEPT
Blood System for Cryoprecipitation and in the United States
generally, and its ability to maintain an effective and qualified
U.S.-based commercial organization, as well as the resulting
uncertainty of its ability to achieve market acceptance of and
otherwise successfully commercialize the INTERCEPT Blood System in
the United States, including as a result of licensure requirements
that must be satisfied by U.S. customers prior to their engaging in
interstate transport of blood components processed using the
INTERCEPT Blood System; risks related to the highly concentrated
market for the INTERCEPT Blood System; risks related to how any
future platelet additive solution (PAS) supply disruption could
affect INTERCEPT’s acceptance in the marketplace; risks related to
how any future PAS supply disruption might affect current
commercial contracts; risks related to Cerus’ ability to
demonstrate to the transfusion medicine community and other health
care constituencies that pathogen reduction, including IFC for the
treatment and control of bleeding, and the INTERCEPT Blood System
is safe, effective and economical; risks related to the uncertain
and time-consuming development and regulatory process, including
the risks that (a) Cerus may be unable to comply with the FDA’s
post-approval requirements for the INTERCEPT Blood System,
including by successfully completing required post-approval
studies, which could result in a loss of U.S. marketing approval(s)
for the INTERCEPT Blood System, (b) any changes to the INTERCEPT
platelet processing sets may require additional aging and stability
data in order to satisfy regulators and maintain historical label
claims; (c) additional manufacturing site Biologics License
Applications necessary for Cerus to more broadly distribute the
INTERCEPT Blood System for Cryoprecipitation may not be obtained in
a timely manner or at all, and (d) Cerus may be unable to obtain
the requisite regulatory approvals to advance its pipeline
programs, including its new LED illuminator in Europe, and bring
them to market in a timely manner or at all; risks related to
product safety, including the risk that the septic platelet
transfusions may not be avoidable with the INTERCEPT Blood System;
risks related to adverse market and economic conditions, including
continued or more severe adverse fluctuations in foreign exchange
rates and/or continued or more severe weakening in economic
conditions resulting from military conflicts, rising interest
rates, inflation, new or increased tariffs and escalating trade
tensions or otherwise in the markets where Cerus currently sells
and is anticipated to sell its products; the fact that Cerus’
estimated total addressable market is subject to inherent
challenges and uncertainties; Cerus’ reliance on third parties to
market, sell, distribute and maintain its products; Cerus’ ability
to maintain an effective, secure manufacturing supply chain,
including the risks that (a) Cerus’ supply chain could be
negatively impacted as a result of the evolving impact of
macroeconomic developments, including the ongoing military conflict
in Ukraine, rising interest rates, inflation, and new or increased
tariffs and escalating trade tensions; (b) Cerus’ manufacturers
could be unable to comply with extensive FDA and foreign regulatory
agency requirements, and (c) Cerus may be unable to maintain its
primary kit manufacturing agreement and its other supply agreements
with its third party suppliers; Cerus’ ability to identify and
obtain additional partners to manufacture the INTERCEPT Blood
System for Cryoprecipitation; risks associated with Cerus’ ability
to access additional funds under its credit facility and to meet
its debt service obligations, and its need for additional funding;
the impact of legislative or regulatory healthcare reforms that may
make it more difficult and costly for Cerus to produce, market and
distribute its products; risks related to future opportunities and
plans, including the uncertainty of Cerus’ future capital
requirements and its future revenues and other financial
performance and results, including as it relates to Cerus’ 2025
annual product revenue guidance and its expectations for full-year
2025 GAAP net loss attributable to Cerus Corporation and non-GAAP
adjusted EBITDA; as well as other risks detailed in Cerus’ filings
with the Securities and Exchange Commission, including under the
heading “Risk Factors” in Cerus’ Quarterly Report on Form 10-Q for
the quarter ended September 30, 2024, filed with the SEC on October
31, 2024. Cerus disclaims any obligation or undertaking to update
or revise any forward-looking statements contained in this press
release.
Use of Non-GAAP Financial Measures
We define adjusted EBITDA as net loss attributable to Cerus
Corporation as reported on the consolidated statement of
operations, as adjusted to exclude, as applicable for the reporting
period(s) presented, (i) net loss attributable to noncontrolling
interest, (ii) provision for income taxes, (iii) foreign exchange
(loss)/gain, (iv) interest income (expense), (v) other income
(expense), net, (vi) depreciation and amortization, (vii)
share-based compensation, (viii) goodwill and asset impairments,
(ix) costs associated with our noncontrolling interest in our joint
venture in China, (x) revenue and direct costs associated with our
government contracts and (xi) restructuring charges. We are
presenting this non-GAAP financial measure to assist investors in
assessing our operating results. Management believes this non-GAAP
information is useful for investors, when considered in conjunction
with Cerus’ GAAP financial statements, because management uses such
information internally for its operating, budgeting and financial
planning purposes. Non-GAAP information is not prepared under a
comprehensive set of accounting rules and should only be used to
supplement an understanding of Cerus’ operating results as reported
under GAAP. This non-GAAP financial measure should not be
considered in isolation from, or as a substitute for, financial
information prepared in accordance with GAAP. This non-GAAP
financial measure is not necessarily comparable to similarly-titled
measures presented by other companies.
Investors should note that Cerus has not provided a
reconciliation of anticipated positive non-GAAP adjusted EBITDA for
the year ending December 31, 2025 to projected GAAP net loss
attributable to Cerus Corporation for the year ending December 31,
2025 because certain items such as share-based compensation that
are components of GAAP net loss attributable to Cerus Corporation
cannot be reasonably projected due to the significant impact of
changes in Cerus’ stock price and other factors. These components
of GAAP net loss attributable to Cerus Corporation could
significantly impact the reported GAAP net loss attributable to
Cerus Corporation.
Supplemental Tables
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2024 vs. 2023
2024 vs. 2023
Platelet Kit Growth
North America
2%
17%
International
23%
7%
Worldwide
7%
14%
Change in Calculated Number of
Treatable Platelet Doses
North America
3%
20%
International
22%
8%
Worldwide
9%
16%
* Dose treatable calculation based on the
number of kits sold and the product configuration (single, double,
and triple dose kits)
CERUS CORPORATION
REVENUE BY REGION
(in thousands, except
percentages)
Three Months Ended
Twelve Months Ended
December 31,
Change
December 31,
Change
Unaudited
Unaudited
2024
2023
$
%
2024
2023
$
%
North America
$
34,011
$
32,110
$
1,901
6
%
$
121,794
$
99,187
$
22,607
23
%
Europe, Middle East and Africa
16,081
13,833
2,248
16
%
56,327
55,008
1,319
2
%
Other
717
825
(108
)
-13
%
2,149
2,172
(23
)
-1
%
Total product revenue
$
50,809
$
46,768
$
4,041
9
%
$
180,270
$
156,367
$
23,903
15
%
CERUS CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per
share data)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
Unaudited
Unaudited
2024
2023
2024
2023
Product revenue
$
50,809
$
46,768
$
180,270
$
156,367
Cost of product revenue
23,424
20,809
80,748
69,967
Gross profit on product revenue
27,385
25,959
99,522
86,400
Government contract revenue
5,942
6,574
21,051
30,430
Operating expenses:
Research and development
15,443
14,288
58,907
67,639
Selling, general and administrative
19,333
17,269
75,891
75,516
Restructuring
-
-
-
3,728
Total operating expenses
34,776
31,557
134,798
146,883
(Loss) Gain from operations
(1,449
)
976
(14,225
)
(30,053
)
Total non-operating expense, net
(1,002
)
(2,293
)
(6,531
)
(7,269
)
Loss before income taxes
(2,451
)
(1,317
)
(20,756
)
(37,322
)
Provision for income taxes
111
72
205
325
Net loss
(2,562
)
(1,389
)
(20,961
)
(37,647
)
Net loss attributable to noncontrolling
interest
(41
)
(61
)
(43
)
(158
)
Net loss attributable to Cerus
Corporation
$
(2,521
)
$
(1,328
)
$
(20,918
)
$
(37,489
)
Net loss per share attributable to Cerus
Corporation:
Basic and diluted
$
(0.01
)
$
(0.01
)
$
(0.11
)
$
(0.21
)
Weighted average shares outstanding:
Basic and diluted
185,734
181,216
184,563
180,270
CERUS CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31,
December 31,
2024
2023
ASSETS
(unaudited)
Current assets:
Cash and cash equivalents
$
20,266
$
11,647
Short-term investments
60,186
54,205
Accounts receivable, net
29,777
35,500
Current inventories
38,150
39,868
Prepaid and other current assets
3,643
3,221
Total current assets
152,022
144,441
Non-current assets:
Property and equipment, net
7,154
8,640
Operating lease right-of-use assets
8,384
10,713
Goodwill
1,316
1,316
Non-current inventories
14,145
19,501
Other assets and restricted cash
17,896
13,137
Total assets
$
200,917
$
197,748
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable and accrued
liabilities
$
40,638
$
43,067
Debt – current
19,297
20,000
Operating lease liabilities – current
2,275
2,452
Deferred revenue – current
1,398
2,002
Total current liabilities
63,608
67,521
Non-current liabilities:
Debt – non-current
64,862
59,796
Operating lease liabilities –
non-current
11,663
13,751
Other non-current liabilities
3,888
3,236
Total liabilities
144,021
144,304
Stockholders' equity:
56,145
52,650
Noncontrolling interest
751
794
Total liabilities and stockholders'
equity
$
200,917
$
197,748
CERUS CORPORATION
UNAUDITED RECONCILIATION OF
NON-GAAP ADJUSTED EBITDA
(in thousands)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2024
2023
2024
2023
Net loss attributable to Cerus
Corporation
$
(2,521
)
$
(1,328
)
$
(20,918
)
$
(37,489
)
Adjustments to net loss attributable to
Cerus Corporation:
Net loss attributable to noncontrolling
interest
(41
)
(61
)
(43
)
(158
)
Provision for income taxes
111
72
205
325
Total non-operating expense, net (i)
1,002
2,293
6,531
7,269
(Loss) income from operations
(1,449
)
976
(14,225
)
(30,053
)
Adjustments to (loss) income from
operations:
Operating depreciation and
amortization
1,104
1,221
4,568
4,534
Government contract revenue (ii)
(5,942
)
(6,574
)
(21,051
)
(30,430
)
Direct expenses attributable to government
contracts (iii)
3,975
4,093
13,488
20,893
Share-based compensation (iv)
5,504
4,903
22,867
20,271
Costs attributable to noncontrolling
interest (v)
82
124
85
334
Restructuring (vi)
-
-
-
3,728
Non-GAAP adjusted EBITDA
$
3,274
$
4,743
$
5,732
$
(10,723
)
- Includes interest income/expense and foreign exchange
gains/losses.
- Represents revenue related to the cost reimbursement provisions
under our government contracts.
- Represents the direct expenses attributable to work supporting
government contracts, which are reimbursed and reflected under
government contract revenue in the condensed consolidated statement
of operations.
- Represents non-cash stock-based compensation.
- Represents costs associated with the noncontrolling interest in
Cerus Zhongbaokang (Shandong) Biomedical Co., LTD.
- Represents costs associated with the Company’s restructuring
plan implemented in June 2023.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250220080176/en/
Noopur Liffick NBL LifeSci Advisory 925-298-2338
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