Cerus Corporation

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024
OR
☐
TRANS
R
ITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission file number 000-21937
CERUS CORPORAT
R
ION
(Exact name of registrant as specified in its charter)
Delaware
68-0262011
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
1220 Concord Avenue, Suite 600,
Concord, Califor
f
nia
94520
(Address of principal executive offi
f ces)
(Zip Code)
(925) 288-6000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol
g
y
Name of Each Exchange on Which Registered
g
g
Common Stock, par value $0.001 per share
CERS
The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(g) of the Act:
Prefer
f
red Share Purchase Rights
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defin
f ed in Rule 405 of the Securities Act.
Yes ☐No ☒
Indicate by check mark if the registrant is not required to fil
f e reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐No ☒
Indicate by check mark whether the registrant: (1) has file
f
d all reports required to be file
f
d by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for
f
such shorter period that the registrant was required to file
f
such reports), and (2) has been subj
u ect to such filing requirements for
f
the past
90 days. Yes ☒No ☐
Indicate by check mark whether the registrant has submitted electronically every I
r
nteractive Data File required to be submitted pursuant to Rul
R e 405 of Regulation
S-T (§232.405 of this chapter) during the preceding 12 months (or for
f
such shorter period that the registrant was required to submit such files). Yes ☒No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large accelerated filer ☐
Accelerated filer ☒
Non-accelerated filer ☐
Smaller reporting company ☐Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
f
complying with any new or
revised fin
f ancial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has file
f
d a report on and attestation to its management’s assessment of the effe
f ctiveness of its internal control over
financial reporting under Section 404(b) of the Sarba
r
nes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting fir
f m that prepared or issued its audit report.
☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing
reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any
of the registrant’s executive offi
f cers dur
d
ing the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rul
R e 12b-2 of the Exchange Act). Yes ☐No ☒
The appr
a
oximate aggregate market value of the voting and non-voting common equity held by non-affi
f liates of the registrant as of June 28, 2024, the last business
day of the registrant’s most recently completed second fiscal quarter, based upon the closing sale price of the registrant’s common stock listed on the Nasdaq Global
Market, was $240 million. (1)
As of Februa
r
ry 6, 2025, there were 185,789,815 shares of the registrant’s common stock outstanding.
DOCUMENTS INCORPORAT
R
ED BY REFERENCE
Portions of the registrant’s defin
f itive proxy statement in connection with the registrant’s 2025 Annual Meeting of Stockholders, to be file
f
d with the Securities and
Exchange Commission pursuant to Regulation 14A not later than 120 days afte
f r the end of the fiscal year ended December 31, 2024, are incorpor
r
ated by reference into
Part III of this Annual Report on Form 10-K.
(1) Based on a closing sale price of $1.76 per share on June 28, 2024. Excludes 49.0 million shares of the registrant’s common stock held by executive officers,
directors and stockholders that the registrant has concluded were affil
f iates at June 30, 2024.

FORM 10-K
For the Fiscal Year Ended December 31, 2024
TABLE OF CONTENTS
Page
PART I
Item 1.
Business
5
Item 1A.
Risk Factors
21
Item 1B.
Unresolved Staff Comments
58
Item 1C.
Cybersecurity
59
Item 2.
Properties
58
Item 3.
Legal Proceedings
60
Item 4.
Mine Safety Disclosures
60
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
61
Item 6.
Reserved
61
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
61
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
74
Item 8.
Financial Statements and Supplementary Data
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
74
Item 9A.
Controls and Procedures
75
Item 9B.
Other Information
77
Item 9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
77
PART III
Item 10.
Directors, Executive Officers and Corpor
r
ate Governance
78
Item 11.
Executive Compensation
78
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13.
Certain Relationships and Related Transactions, and Director Independence
79
Item 14.
Principal Accountant Fees and Services
79
PART IV
Item 15.
Exhibits and Financial Statement Schedul
d es
80
Item 16.
Form 10-K Summary
85
SIGNATURES
114

3
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on For
F
m 1
r
0-K c
-
ontains for
f
ward-l
d ooki
l
ng
i
stat
t em
t
ents with
i
in the meaning
i
of Sectio
t n 27A of the Sec
S
uritie
t s Act of
1933, as amended, and Sec
S
tion 21E of the Sec
S
uritie
t s and Exchange Act of 1
o
934, as amended, that involve risks and uncertainties.
The for
f
ward-l
d ooki
l
ng
i
stat
t em
t
ents are contained principal
i
ly
l
in Item
t
1, “Business,” Ite
I m 7, “
7
Ma
“
nage
a
ment’s Disc
i
ussion and Analysisi
of Fina
i
ncial Con
C
ditio
i
n and Results of Operatio
t ns,”
s
and in I
i
te
I m 1A,
1
“Risk Fac
F
tors.” The
T
se stat
t em
t
ents relate to future events or to
our fut
f
ure ope
o
rating or fin
f
ancial perfor
f
ma
r
nce and involve known and unknown risk
i
s,
k
uncertai
t nt
i
ie
t s and othe
t
r fac
f
tors that may c
a
ause
our actual results
l , p
s
erfo
r
rmance or achievements to be materially
l
diffe
i
rent from any f
n
ut
f
ure results
l , p
s
erfo
r
rmance or achievements
expr
x
essed or imp
i
lied by t
b
he
t
forward-looking
i
stat
t em
t
ents. The
T
se forward-looking
i
stat
t em
t
ents may i
a
nc
i
lude, b
e
ut are not limite
i
d to,
t
stat
t em
t
ents about:
•
the imp
i
act of m
o
acroeconomic developm
o
ents, i
s
nc
i
luding
i
escalating tra
t
de tensions and the
t
ongoing
i
confli
f ct between
Ukraine and Russia on our busine
i
ss and ope
o
rations as well a
l
s the
t
busine
i
ss or operations of our customers,
manufac
f
turers, research partners,
r
and other third parties with w
t
hom we conduct busine
i
ss;
•
future sales of a
o
nd anticipat
i
ed
t
demand for, and our ability
i
to effe
f ctiv
t ely c
l
ommercialize and achieve marke
r
t accept
e an
t
ce
of the INT
I
ERCEP
T
T™Blood
l
System
t
, inc
i
luding
i
our ability
i
to comply with
i
applic
l able U
l
ni
U
te
i d Sta
S tes, or U.S., and foreign
g
laws, r
s
egulat
l io
t ns and regulat
l or
t
y r
r
equire
i
ments;
t
•
our ability
i
to successfu
s
lly complete the devel
d
opm
l
ent of,
o
receive regulat
l or
t
y a
r
ppr
a
ovals f
l
or
f
and commercialize
i
the red blood
l
cell s
l
ys
s
tem;
•
our strateg
t
y a
g
nd the poten
t
tial therapeutic
t
applic
l atio
t ns for the
t
INTE
N
RCEP
E
T Blood System
t
;
•
our ability
i
to manage
a
the growth o
t
f o
o
ur busine
i
ss and attendan
d
t cost inc
i
reases, i
s
nc
i
luding
i
in connectio
t n with t
t
he
t
commercializatio
t n of t
o
he
t
INTE
N
RC
E
EP
C
T Blood System
t
in the U.S
U
.,
S as well as our abili
i ty
i
to manage
a
the risks atte
t ndan
d
t tot
our int
i
er
t
national ope
o
rations;
•
the timi
t
ng
i
or like
i
liho
i
od of regu
e
latory submissions and approvals a
l
nd othe
t
r regulat
l or
t
y a
r
ctio
t ns or interactio
t ns, i
s nc
i
luding
i
whethe
t
r we will s
l
ubmit a new applic
l atio
t n for
f
confor
f
mi
r
ty
i
assessment to o
t
btai
t n a
i
CE Certif
t ic
f ate o
t
f C
o
on
C
fo
n
rmity to affi
f x t
i
he
t
CE Mark to the red blood
l
cell system
t
, whether data e
t
xi
e st
i
to suppor
u
t a clas
l
sifi
i cation of c
o
ompou
m
nds f
d
or
f
approval, w
l
hether
existing clini
i
cal dat
d a w
t
ould be suff
u ic
f ient to eith
i
er submit or poten
t
tially
l
obtai
t n a
i
ppr
a
oval of any s
n
uch new applic
l atio
t n, and
whethe
t
r our plan
l
ned modular premarket approval, o
l
r PMA
P
, appl
a
ic
l atio
t n for
f
the red blood
l
cell s
l
ys
s
tem will b
l
e submitte
i
d
to the U.S
U
. F
S
ood
F
and Drug A
u
dministratio
t n, or FDA,
D
on the time
t
line we antic
t ipate o
t
r at all;l
•
our ability
i
to obtai
t n a
i
nd maintain regu
e
latory approvals o
l
f t
o
he
t
INTE
N
RCEP
E
T Blood System
t
;
•
our abilit
i
y t
t
o o
t
btai
t n a
i
dequate c
t
lini
i
cal and commercial suppl
u
ie
l s of t
o
he
t
INTE
N
RCEP
E
T Blood System
t
from our sole s
l
ource
suppl
u
ie
l rs for a particular
l
product or component the
t
y m
e
anufac
f
ture;
•
the ini
i
ti
i atio
t n, scope, rate of pr
f
ogress, results and tim
t
ing of o
o
ur ongoing
i
and propos
o
ed preclinical and clini
i
cal tri
t als o
l
f
o
the INT
I
ERCEP
T
T Blood System
t
;
•
the successful
f
completion of our research, developm
l
ent and clin
l
ical programs and our abilit
i
y t
t
o m
t
anage cost increases
associated
t
with
i
preclinical and clini
i
cal devel
d
opm
l
ent of t
o
he
t
INTE
N
RCEP
E
T Blood System
t
;
•
the amount and availabi
l
lity
i
of fu
f
ndin
d
g we may receive under our government contracts with
i
the Biomedical Advanced
Research and Developm
l
ent Autho
t
rity
i , o
y
r BARD
B
A,
D
the U.S
U
. D
S
epartment of D
o
efen
f
se, o
e
r DoD, a
D
nd the FDA
F
;
•
our abilit
i
y t
t
o t
t
ra
t
nsition dis
d tributio
t n of t
o
he
t
INTE
N
RCEP
E
T Blood System
t
from third parties to a d
t
ir
d ect sales
l
model in c
i
ertain
internatio
t nal marke
r
ts;
•
the abili
i ty
i
of our products t
t
o i
t
na
i
ctiv
t ate t
t
he
t
emergi
r ng
i
viru
i
ses and othe
t
r patho
t
ge
o
ns that we may t
a
ar
t
ge
r
t in t
i
he
t
future;
•
our ability
i
to protect
t
our int
i
el
t le
l ctual prope
o
rty a
t
nd operate our business without inf
i
ri
f ng
i
ing upon
u
the int
i
el
t le
l ctual prope
o
rtyt
righ
i
ts of othe
t
rs;
•
our estim
t
ates
t
regar
e
ding
i
the suffi
f ciency of our cash resources, o
s
ur ability
i
to contin
t
ue as a going
i
concern and our need
for additio
i
nal fun
f
ding
i
; a
g
nd
•
our plans, o
s
bjectiv
t es, e
s
xpe
e
ctat
t io
t ns and int
i
en
t
tions and any o
n
ther stat
t em
t
ents that are not hist
i or
t
ical facts.
t
In some cases, you can iden
d
tify
i
forward-looking
i
stat
t em
t
ents by terms such as “an
“
ticipate,
t ” “wi
“
ll,
i
” “be
“
lieve,” “es
“
tima
i
te,”
e
“expe
e
ct,”
t
“plan
l
,” “may,”
y
“should,”
l
“could,”
d
“would,”
d
“project,”
t
“predic
d t,” “pot
“
en
t
tial,” and simila
i
r expr
e
essions int
i
en
t
ded to i
t
dentif
t y s
f
uch
forward-looking
i
stat
t em
t
ents. For
F
ward-l
d ooki
l
ng
i
stat
t em
t
ents refl
e ect
l
our current views with r
t
espe
s
ct to future events, a
s
re based on
assumptions, a
s
nd are subje
b ct to risk
i
s a
k
nd uncertai
t nt
i
ie
t s. There can be no assurance tha
t
t any of the events anticipated
t
by forward-
d

4
looking
i
stat
t em
t
ents will
i
occur or, if any o
n
f t
o
he
t
m do o
d
ccur, w
r
hat imp
i
act the
t
y w
e
ill h
l
ave on our busine
i
ss, results o
t
f o
o
pe
o
rations and
fina
i
ncial conditi
i on. Cer
C
tain impor
m
tant factor
t
s c
r
ould cause actual results
l
to diffe
i
r mater
t
ially f
l
ro
f
m tho
t
se disc
i
ussed in s
i
uch statements,
t
includin
d
g the
t
rate of custom
t
er adoptio
t n in t
i
he
t
U.S. and our ability
i
to achieve market accept
e an
t
ce of our products i
t
n t
i
he
t
U.S. and
internatio
t nal marke
r
ts, w
s
hether our preclin
l
ical and clini
i
cal dat
d a o
t
r dat
d a f
t
ro
f
m commercial use will
i
be consider
d
ed suff
u ic
f ient by
regu
e
latory authoritie
t s or Not
N if
t ie
f d Bodies to grant marke
r
ting app
a
roval or receive CE C
C
er
C
tific
f ates
t
of Confor
f
mi
r
ty
i
for our products o
t
r
for product extensions or additi
i onal clai
l ms
i
for our products,
t
our ability
i
to obtai
t n r
i
eimb
i
urse
r
ment approval for our products,
t
changes
in regu
e
latory approval or certif
t ic
f atio
t n require
i
ments f
t
or
f
our products,
t
our ability
i
to complete the devel
d
opm
l
ent and testin
t
g of
o
additi
i onal config
f uratio
t ns or redesign
i
s of o
o
ur products,
t
our need for additi
i onal fina
i
ncing and our abili
i ty
i
to access fundin
d
g under
d
our agr
a
eements w
t
ith BARDA,
D
the DoD, a
D
nd the FDA
F
, the
t
impacts of regu
e
lation of our products b
t
y d
b
om
d
estic and for
f
eign
i
regu
e
latory
authorities, our lim
l
ited exp
e
erience in s
i
ales
l
, m
s
arke
r
ting
i
and regulat
l or
t
y s
r
uppor
p
t for
f
the INT
I
ERCEP
T
T Blood System
t
, our reliance on
Fresenius Kabi
K
AG and other third parties to m
t
anufac
f
ture and suppl
p y c
l
ertain components of the INT
I
ERCEP
T
T Blood System
t
,
incompatib
t ility of our platelet sys
s
tem with some commercial platelet colle
l ctio
t n metho
t
ds, o
s
ur need to complete our red bloo
l
d celll
system
t
’s commercial des
d
ign,
g
more effe
f ctiv
t e product offe
f ring
i
s b
g
y,
b
or clin
l
ical setbacks of o
f
ur competito
t
rs, product liabili
i ty
i , o
y
ur use
of hazardou
d
s mater
t
ials in the devel
d
opm
l
ent of o
o
ur products, b
s
usiness int
i
er
t
rupt
u io
t n due to earthq
t
uake, o
e
ur expe
x
ctat
t io
t n of c
o
ontinu
i
ing
losses, protect
t
io
t n of o
o
ur intellect
l
ual prope
o
rty r
t
ight
g
s,
t
volatility in our stock price, on-going
i
compliance with the require
i
ments o
t
f t
o
he
t
Sarbanes-Oxl
O ey
l
Act of 2
o
002, adverse
r
market and economic conditio
d
ns, i
s nc
i
luding
i
those resulti
l ng
i
from the effe
e
cts o
t
f m
o
acroeconomic
conditi
d
ons, and other factor
t
s d
r
is
d cussed below and under the
t
capt
a io
t n “Ri
“
sk
i
Factor
t
s,
r ” in I
i
te
I m 1A o
1
f t
o
hi
t
s A
i
nnual Report on For
F
m 1
r
0-
K. We disc
i
uss many o
n
f t
o
he
t
se risk
i
s i
k
n t
i
hi
t
s A
i
nnual Report on For
F
m 1
r
0-K i
-
n g
i
reater
t
detail in the section titl
t
ed
l
“Risk Fac
F
tors” under
Part I, Item
t
1A below. Given these uncertainties, y
s
ou should not place undue reliance on these for
f
ward-l
d ooki
l
ng
i
stat
t em
t
ents. Also,
forward-looking
i
stat
t em
t
ents repr
e
esent our estima
i
tes and assumptions only as of the dat
d e o
t
f t
o
hi
t
s A
i
nnual Report on For
F
m 1
r
0-K.
-
You
should read this Annual Report on For
F
m 1
r
0-K a
-
nd the doc
d
uments that we incorporate b
t
y r
b
efer
f
ence in and have file
f
d as exh
e
ibits t
t
ot
this Annual Report on For
F
m 1
r
0-K c
-
ompl
m et
l el
t y.
l
Our actual fut
f
ure results
l
may b
a
e mater
t
ially diffe
i
rent from what we expe
x
ct. E
t
xc
E
ept as
required by law, we assume no oblig
l atio
t n to u
t
pd
u
at
d e o
t
r revise
i
any f
n
or
f
ward-l
d ooki
l
ng
i
stat
t em
t
ents to refl
e ect
l
new inf
i
or
f
ma
r
tion or future
events, e
s
ven if n
i
ew info
n
rmatio
t n becomes available i
l
n t
i
he
t
future. Y
e
ou
Y
should not assume tha
t
t our sile
i nce over time
t
means tha
t
t actual
events are bearing
i
out as exp
e
ressed or imp
i
lied in such forward-looking
i
stat
t em
t
ents.
RISK FACTOR SUMMARY
Investing in our securities involves a high degree of risk. Below is a summary of material factors that make an investment in our securities
speculative or risky.
k
Importantly, this summary does not address all of the risks that we face. Additional discussion of the risks
summarized in this risk fact
f
or summary, as well as other risks that we fac
f
e, can be found under the heading “Item 1A—Ri
—
sk
i
Factorsr ”
in Part I of this Annual Report on Form 10-K.
•
We depend subs
u
tantially upon the commercial success of the INTERCEPT Blood System for platelets, plasma and
cryopr
r
ecipitation in the U.S., and our inability to successful
f ly commercialize the INTERCEPT Blood System in the U.S.
would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
•
The INTERCEPT Blood System may not achieve or be abl
a e to sustain broad market adoption.
•
We are exposed to risks associated with the highly concentrated market for the INTERCEPT Blood System.
•
We may be unabl
a e to develop and maintain an effective and qualifie
f d commercial organization or educate blood centers,
clinicians and hospital personnel. As a result, we may not be able to successful
f ly educ
d
ate the market on the value of pathogen
reduction or commercialize our products.
•
We have very limited experience selling directly to hospitals or expertise complying with regulations governing fin
f ished
biologics, and our inability to successful
f ly commercialize the INTERCEPT Blood System for cryoprecipitation in the U.S.
would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
•
If our competitors develop products supe
u
rior to ours, market their products more effe
f ctively, or receive regulatory a
r
ppr
a
oval
or certification befor
f
e our products, our commercial opportunities could be reduc
d
ed or be eliminated. Competitors have and
may continue to file claims in order to impede the marketability of our products, regardless of the merit of such claims.
•
Clinical trials are costly and time consuming, may take longer than we expect or may not be completed at all, and their
outcomes are uncertain. A failure to generate data in clinical trials to suppor
u
t expanded label claims or to suppor
u
t marketing
approvals or certific
f ation for
f
our product candidates could materially and adversely affect our business, financial condition,
results of operations and growth prospects.
•
The red blood cell system is currently in development and may never receive any marketing appr
a
ovals or CE Certific
f ates
of Confor
f
mity.
•
Our company, our products, and blood products treated with the INTERCEPT Blood System are subject to extensive
regulation by domestic authorities, foreign authorities and Notified Bodies.

5
•
If we or our third-party suppliers fai
f l to comply with the U.S. Food and Drug Administration’s, or FDA’s, or other regulatory
r
authorities’ good manufact
f
ur
t
ing practice regulations, it could impair our ability to market our products in a cost-effe
f ctive
and timely manner.
•
If we modify our FDA-approved or CE Marked products, we may need to seek additional appr
a
ovals or certific
f ation, which,
if not granted, would prevent us from selling our modified products.
•
We are subject to fed
f
eral, state and for
f
eign laws governing our business practices which, if violated, could result in
subs
u
tantial penalties and harm our reputation and business.
•
A significant portion of the funding for the development of the red blood cell system has come and is expected to continue
to come from our BARDA agreements, and if BARDA were to eliminate, reduce or delay, or object to extensions for fundi
f
ng
of our agreements, it would have a significant, negative impact on our government contract revenues and cash flo
f ws, and
we may be for
f
ced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of
funding. Our abi
a lity to be paid by the DoD is predicated on our ability to achieve the stated milestones in the agreement and
for the DoD to agree with the successful
f
completion of each.
•
We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in
certain countries.
•
Our manufact
f
ur
t
ing supply chain exposes us to significant risks.
•
We may continue to generate losses and never achieve a profitabl
a e level of operations.
•
If we fail to obtain the capital necessary to fund our future operations or if we are unabl
a e to generate continued positive cash
flows fro
f
m our operations, we will need to curtail planned development or sales and commercialization activities.
•
We operate a complex global commercial organization, with limited experience in many countries. We have limited
resources and experience complying with regulatory,
r
legal, tax and political complexities as we expand into new and
increasingly broad geographies. We may be distracted by expansion into new geographies where we do not have experience
and we may be unsuccessful
f
in monetizing such opportunities for the benefit of our organization at large.
•
Adverse market and economic conditions may exacerba
r
te certain risks affecting our business.
•
Risks associated with our operations outside of the United States could adversely affect our business.
•
We may not be able to protect our intellectua
t
l property or operate our business without infringing intellectua
t
l property rights
of others.
•
Our stock price is volatile and your investment may suffe
f r a decline in value.
Item 1. Busine
i
ss
Overview
We are a biomedical products company foc
f
used on developing and commercializing the INTERCEPT Blood System to enhance blood
safety. The INTERCEPT Blood System, which is based on our proprietary technology for controlling biological replication, is designed
to reduce blood-borne pathogens in donated blood components intended for
f
transfus
f
ion.
Our INTERCEPT Blood System is intended for
f
use with blood components and certain of their derivatives: platelets, plasma, red blood
cells and to produce INTERCEPT Fibrinogen Complex, or IFC, and pathogen reduc
d
ed plasma, cryoprecipitate reduced. The
INTERCEPT Blood System for platelets, or platelet system, and the INTERCEPT Blood System for plasma, or plasma system, have
received a broad range of regulatory a
r
ppr
a
ovals and certific
f ation, including but not limited to FDA appr
a
oval in the U.S., CE Certific
f ates
of Confor
f
mity delivered in accordance with the Medical Devices Directive 93/42/EEC, or MDD, and the Medical Devices Regulation
2017/745, or MDR, permitting us to affix
f
the CE Mark to our products and place them on the market in the European Union and other
jurisdictions that recognize the CE Mark, and are being marketed and sold in a number of countries around the world, including the
U.S., certain countries in Europe, the Commonwealth of Independent States, or CIS, the Middle East, and Latin America and selected
countries in other regions of the world. Additionally, we have received FDA approval for
f
the INTERCEPT Blood System for
Cryopr
r
ecipitation. The INTERCEPT Blood System for Cryoprecipitation uses our plasma system to produce IFC for the treatment and
control of bleeding, including massive hemorrhage, associated with fibrinogen defic
f iency. In addition, the INTERCEPT Blood System
for Cryoprecipitation is used to produce pathogen reduc
d
ed plasma, cryoprecipitate reduced. We currently sell the platelet and plasma
systems using our direct sales for
f
ce and through distributors and sell IFC or disposable kits to manufact
f
ur
t
e IFC in the U.S. using our
direct sales for
f
ce. If we are unabl
a e to gain or maintain widespread commercial adoption in markets where our blood safety products are
approved for
f
commercialization, including in the U.S., we will have difficulties achieving and maintaining profita
f
bi
a lity.

6
The INTERCEPT Blood System for red blood cells, or the red blood cell system, is currently in development. In the U.S., we are
currently conducting a Phase 3 clinical trial - the RedeS study,
t
to assess the safet
f y and effi
f cacy of INTERCEPT-treated red blood cells
when compared to conventional, un-treated, red blood cells. With respect to our MDR appl
a
ication in the European Union, or EU, we
announced in October 2024 that the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for the red blood cell system,
reviewed the active pharmaceutical ingredient module of our MDR appl
a
ication and concluded that the data included in the module were
insufficient to support the proposed classification of the impurity profile
f
of the fin
f al product, necessitating the closure of our MDR
application without an approval. In collaboration with TÜV-SÜD, our Notifie
f d Body for the red blood cell system, we are assessing
strategies for a potential new MDR app
a
lication, including data to address the classification questions raised by CBG. We cannot predict
with certainty when, if ever, we will be able to satisfactorily address CBG’s conclusions and as such, cannot predict if or when we will
subm
u
it a new MDR app
a
lication for
f
the red blood cell system and, if subm
u
itted, when a decision concerning certific
f ation would occur.
In addition, as a result of the failure to obtain app
a
roval of our MDR appl
a
ication, our product development costs will be ongoing. See
also the risk fact
f
or entitled “The red blood system is currently in development and may never receive any marketing appr
a
ovals or CE
Certific
f ates of Confor
f
mity” under “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K.
Contribution margins from our sales is likely to be less than the cost of our operating expenses. In order to successfully commercialize
all of our products and product candidates, we will be required to conduct significant research, development, preclinical and clinical
evaluation, commercialization and regulatory c
r
ompliance activities for
f
our products and product candidates, which, together with
anticipated increased selling, general and administrative expenses, are expected to result in subs
u
tantial operating losses. Accordingly,
we may never achieve a profitabl
a e level of operations in the fut
f ur
t
e.
We were incorporated in Califor
f
nia in 1991 and reincorpo
r
rated in Delaware in 1996. Our wholly-owned subs
u
idiary, Cerus
r
Europe B.V.,
was for
f
med in the Netherlands in 2006. Information regarding our revenues, net losses, and total assets for the last three fis
f cal years can
be found in the consolidated financial statements and related notes found elsewhere in this Annual Report on Form 10-K.
Product Development
Backgr
k
ound
The INTERCEPT Blood System is designed to broadly target and inactivate blood-borne pathogens, such as virus
r
es (for example, HIV,
West Nile, SARS, hepatitis B and C), bacteria and parasites, as well as potentially harmful white blood cells, while preserving the
therapeutic properties of platelet, plasma, red blood cell and IFC transfus
f
ion products. The INTERCEPT Blood System has been shown
to inactivate a broad array of pathogens and has the potential to reduce the risk of transfus
f
ion related transmission of pathogens for
which testing is not completely effe
f ctive, is not availabl
a e or is not performed. We believe that the INTERCEPT Blood System also has
the potential to inactivate most new pathogens before they are identifie
f d and before tests are developed and adopted commercially to
detect their presence in donated blood.
Products,
t
Product Candid
d at
d es
t
and Developm
l
ent Activ
t ities
The fol
f lowing tabl
a e identifie
f s our products, product candidates and product development activities and their current status
t
:
Product or Product Candidate Under Development
Product or Development Status
INTERCEPT Blood System—P
m
latelets
• Commercialized in the U.S., Canada and a number of countries in Europe,
the CIS, the Middle East, and selected countries in other regions around the
world
• Received CE Certificate of Confor
f
mity under MDR in December 2023
INTERCEPT Blood System—P
m
lasma
• Commercialized in the U.S. and a number of countries in Europe, the CIS,
the Middle East, and selected countries in other regions around the world
• Received CE Certificate of Confor
f
mity under MDR in December 2023
• Received FDA approval of the premarket appr
a
oval supplement, or PMA, to
produce IFC in 2020
INTERCEPT Blood System—R
m
ed Blood Cells
• U.S. Phase 3 clinical trial, known as the RedeS study, enrolling patients
• U.S. Phase 3 acute anemia clinical trial, known as the ReCePI study,
t
completed in 2024
• Additional U.S. studies also planned
• European Phase 3 acute anemia clinical trial completed in 2014; European
Phase 3 chronic anemia clinical trial completed in 2017
• Resubm
u
ission of application for
f
CE Certific
f ate of Confor
f
mity under MDR
would be required in order to potentially obtain marketing appr
a
oval in Europe

7
INTERCEPT Blood System—C
m
ryoprecipitation
• FDA appr
a
oval in November 2020
• U.S. agreement with certain blood center manufact
f
ur
t
ing partners
• Limited commercialization in the U.S.
INTE
N
RC
E
EPT
C
Blood Syst
y em for Platelets, Plasma and Cryo
r
pr
o
ecipi
i tation
The platelet system and plasma system are designed to inactivate blood-borne pathogens in platelets and plasma donated for
f
transfus
f
ion.
Both systems received a CE Certific
f ate of Confor
f
mity permitting us to affix the CE Mark in the European Economic Area, or EEA, and
FDA appr
a
oval in the U.S. and are currently marketed and sold in a number of countries around the world including the U.S., countries
in Europe, the CIS, the Middle East and selected countries in other regions of the world. Separate appr
a
ovals for use of INTERCEPT-
treated platelet and plasma products have been obtained in France and Switzerland. In Germany and Austria, where appr
a
ovals must be
obtained by individual blood centers for use of INTERCEPT-treated platelets and plasma, several centers have obtained such appr
a
ovals
for use of INTERCEPT-treated platelets and INTERCEPT-treated plasma. Many countries outside of the European Union recognize the
CE Mark and have varyi
r ng additional administrative or regulatory p
r
rocesses that must be completed befor
f
e the platelet system or plasma
system can be made commercially availabl
a e. In general, these processes do not require additional clinical trials. Regardless, some
potential customers may desire to conduct their own clinical stud
t
ies befor
f
e adopting the platelet system or plasma system. We have
received CE Certificates of Conformity to affi
f x the CE Mark in accordance with the MDR for our INTERCEPT platelet and plasma
systems which allows us to continue to place our platelet and plasma systems on the European Union market under the new regulatory
r
requirements of the MDR. The FDA has app
a
roved the platelet system for ex vivo preparation of pathogen-reduced apheresis platelet
components collected and stored in 100% plasma or InterSol in order to reduc
d
e the risk of transfus
f
ion-transmitted infec
f
tion, or TTI,
including sepsis, and as an alternative to gamma irradiation for
f
prevention of transfus
f
ion-associated graft v
f
ersus host disease. We have
completed the two post-approval studies that FDA required as part of its approval of the platelet system - a haemovigilance study
evaluating the incidence of acute lung inju
n ry following transfus
f
ion of INTERCEPT-treated platelets as well as a recovery study
t
of
platelets treated with the platelet system. The FDA has also appr
a
oved the plasma system for ex vivo preparation of plasma in order to
reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion.
We have also received FDA appr
a
oval for
f
the INTERCEPT Blood System for Cryoprecipitation, which uses our plasma system to
produce IFC for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen defic
f iency and to
produce pathogen reduc
d
ed plasma, cryoprecipitate reduced.
We expect our commercial efforts in 2025 will continue to largely be foc
f
used on enabling blood centers that are using INTERCEPT to
increase the number of platelet and plasma units produced and made availabl
a e to patients. In addition, we plan to sell the INTERCEPT
Blood System for Cryoprecipitation to certain blood center customers and to sell IFC to hospital customers. In addition, we plan to
continue to develop awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including conventional,
un-treated components. To enable broader patient access to IFC in the U.S., U.S.-based blood centers need to complete process
validations and obtain site-specific licenses fro
f
m the FDA Center for
f
Biologics Evaluation and Research, or CBER, before IFC can be
made availabl
a e to hospital customers outside of the state of IFC production. We have contracted with several blood centers to produce
IFC for
f
us which we sell directly to hospitals and to other blood centers. Of the blood centers that we have contracted with to produce
IFC for
f
us, all have received their interstate licenses, or BLAs. Further, the hospital customers of blood centers may need to complete
changes to their administrative processes of generating internal tracking codes to integrate INTERCEPT-treated produc
d
ts into their
inventories prior to receiving INTERCEPT-treated components. In addition, we estimate that the majority of platelets used in the U.S.
are collected by apheresis, which is part of our FDA-approved label for the platelet system, though a significant minority are prepared
from pooled random donor platelets derived from whole blood collections. While availabl
a e in Europe and other regions around the
world, in order to gain FDA approval for
f
a pathogen reduc
d
tion system compatible with triple dose collections and random donor platelets,
we will need to perform additional product development and testing, including additional clinical trials, and will need to obtain FDA
approval of a PMA supplement. We do not currently have plans to pursue these config
f urations. In addition, we may pursue development
projects for
f
other plasma derived biological products, which may require the submission and appr
a
oval of additional PMA suppl
u
ements
for the plasma system. We also understand that we will need to obtain new PMAs for our INTERCEPT platelet and plasma systems for
use with our new LED-based illuminator. These development activities will be costly and may not be successful
f
should we choose to
pursue them. Our fai
f lure to seek and obtain FDA and for
f
eign regulatory a
r
ppr
a
ovals or certific
f ation of new config
f urations could limit
revenues fro
f
m sales of our products.
INTE
N
RC
E
EPT
C
Blood Syst
y em for Red Blood Cellsl
The red blood cell system is designed to inactivate blood-borne pathogens in red blood cells intended for
f
transfus
f
ion. We completed a
series of in vitro and in vivo tests with the red blood cell system, including successful
f ly completing recovery and survival studies
measuring red cell recovery twenty-four hours after transfus
f
ion. Previously, we terminated Phase 3 clinical trials for acute and chronic
anemia using a prior generation of the red blood cell system due
d
to the detection of antibody reactivity to INTERCEPT-treated red blood
cells, or RBCs, in two patients in the trial for chronic anemia. The antibody eventually cleared and the subjects had no adverse health
consequences. After unblinding the data fro
f
m the original Phase 3 clinical trials, we found
f
that we had met the primary endpoint in the

8
clinical trial for
f
acute anemia. We evaluated the antibodies detected and developed process changes to diminish the likelihood of
antibody reactivity in RBCs treated with our modified process. We have since successfully completed European Phase 3 clinical trials
of the red blood cell system for
f
subj
u ects with acute and chronic anemia patients to support an appl
a
ication for
f
a CE Certific
f ate of
Confor
f
mity. We initially fil
f ed an appl
a
ication for
f
a CE Certific
f ate of Confor
f
mity for the red blood cell system in December 2018 under
the Medical Device Directive, or MDD, and in June 2021, we completed our application for
f
a CE Certific
f ate of Conformity under the
new MDR. In October 2024, we announced CBG, the Competent Authority for
f
the red blood cell system, concluded that the data
provided regarding the medicinal product or active pharmaceutical ingredient of our MDR appl
a
ication were insuffi
f cient to support the
proposed classification of the impurity profile of the fin
f al product, necessitating the closure of our MDR appl
a
ication without an approval.
In collabor
a
ation with TÜV-SÜD, we are assessing strategies for
f
a potential new MDR appl
a
ication, including data to address the
classification questions raised by CBG. We cannot predict with certainty when, if ever, we will be able to satisfact
f
orily address CBG’s
conclusions and as such cannot predict if or when we will subm
u
it a new MDR appl
a
ication for
f
the red blood cell system and, if subm
u
itted,
when a decision concerning certific
f ation would occur. See also the risk fact
f
or entitled “The red blood cell system is currently in
development and may never receive any marketing approvals or CE Certific
f ate of Confor
f
mity” under “Item 1A—Ri
—
sk
i
Factorsr ” of this
Annual Report on Form 10-K.
We previously completed a European Phase 3 clinical trial of RBCs treated with the INTERCEPT Blood System for acute anemia in
cardiovascular surgery s
r
ubjects announced that the trial met its primary endpoint, with preliminary a
r
nalysis demonstrating that the mean
hemoglobin content (53.1g) of INTERCEPT-treated RBCs, on day 35 of storage met the protocol-defined criteria for
f
equivalence based
on the infer
f iority margin of 5g compared to conventional RBCs (55.8g). The randomized, double-blind, controlled, multi-center Phase
3 clinical trial of the red blood cell system evaluated the effi
f cacy of the red blood cell system to process RBCs with quality and mean
hemoglobin content (>40 g) suitabl
a e to support transfusion according to the European Directorate for
f
the Quality of Medicines. The
blood components were transfused to 51 cardiovascular surgery s
r
ubjects at two German clinical trial sites to evaluate transfusion effi
f cacy
and overall safety. There were no clinically relevant trends in severe or serious treatment related adverse events by system organ class.
The observed adverse events were within the expected spectrum of co-morbidity and mortality for subjects of similar age and with
advanced cardiovascular diseases undergoing cardiovascular surgery r
r
equiring red cell transfusion. No subj
u ects exhibited an immune
response to INTERCEPT-treated RBCs. Additionally, we previously announced that the European Phase 3 clinical trial of chronic
anemia evaluating INTERCEPT-treated RBCs in thalassemia subj
u ects met its primary effi
f cacy and safet
f y endpoints. Regardless of the
potential sufficiency of clinical data required to receive a CE Certificate of Confor
f
mity, we understand that we will need to generate
additional safet
f y data fro
f
m commercial use in order to achieve broad market acceptance, if ever certified.
In the U.S., we successfully completed a Phase 2 recovery and lifes
f
pan study of INTERCEPT-treated RBCs. Subsequently, we initiated
a double-blind Phase 3 clinical study,
t
known as the RedeS study, to assess the safet
f y and effi
f cacy of INTERCEPT-treated RBCs when
compared to conventional RBCs in regions impacted by the Zika virus
r
epidemic. The RedeS study was expanded to other areas at risk
for transfusion-transmitted infect
f
ions. The FDA has agreed to modify the criteria for
f
a clinical pause if we see three or more treatment
emergent antibodies with amustaline specific
f ity without evidence of hemolysis in patients receiving INTERCEPT-treated RBCs in our
RedeS study. We are now allowed to continue study
t
enrollment for the RedeS study while we investigate the clinical significance of the
antibodies. If we determine that there is no clinical significance and no impact on patients, then there will be no impact on study
t
enrollment. If treatment emergent antibody reactions associated with hemolysis are observed in any of our Phase 3 trials, the FDA will
require us to place a clinical hold and we will need to investigate the underlying cause. Such investigations may be diffi
f cult for us to
assess imputability which may lead to a complete halt of the clinical trial, may irreparabl
a y harm our red blood cell product’s reputation
and may force us to suspend or terminate development activities related to the red blood cell system in the U.S., which would have a
material adverse effect
f
on our business and business prospects. The trial has been fur
f
ther expanded to include a 6-month chronic phase
for subjects requiring simple repeat transfus
f
ions and also to include up to thirty patients with Sickle Cell Disease requiring red cell
exchange. Subjects that would qualify for inclusion into the chronic phase would be those with conditions such as Sickle Cell Disease,
Thalassemia or Myelodysplasia. This expansion of study
t
population requires the inclusion of additional sites beyond the nine currently
engaged in the trial up t
u
o fif
f te
f en. RedeS is a double-blind, controlled, parallel group study
t
where up t
u
o 800 subj
u ects will be randomized
to receive either 28 days, or 28 days plus 6 months of transfus
f
ion support with INTERCEPT-treated RBCs or conventional RBCs, with
a primary endpoint of hemoglobin increment following transfus
f
ion. These data fro
f
m the expanded RedeS study,
t
if positive, are expected
to suppor
u
t our chronic use assessment in our planned modular premarket appr
a
oval, or PMA, application for
f
the red blood cell system
that we plan to subm
u
it to the FDA.
In March 2024, we announced positive topline results from a Phase 3 clinical trial in the U.S., known as the ReCePI study,
t
that was
designed to evaluate the effi
f cacy and safet
f y of INTERCEPT-treated red blood cells in patients requiring transfus
f
ion for
f
acute blood loss
during surgery. The ReCePI stud
t
y met its primary effi
f cacy endpoint, demonstrating non-inferiority for
f
INTERCEPT RBCs compared
to conventional RBCs as measured by the incidence of acute kidney injury (
r
AKI) fol
f lowing transfus
f
ion of study RBCs. A total of 581
patients were enrolled and randomized across 18 clinical study
t
sites. The modified intention-to-treat, or mITT, population included 321
patients requiring RBC transfus
f
ions in the trial. Not all enrolled patients required RBC transfus
f
ions. Subjects were randomized on a 1:1
basis either to the treatment arm transfused with INTERCEPT RBCs or to the control arm transfus
f
ed with conventional RBCs. The
primary effi
f cacy endpoint was the proportion of subjects experiencing acute kidney injury a
r
s an assessment of RBC effi
f cacy in providing
tissue oxygenation, measured as an increase in serum
r
creatinine compared to pre-surgery, baseline levels within 48 hours after the

9
surgery.
r
The ReCePI study was and the RedeS study
t
is being funde
f
d as part of our initial agreement with BARDA. In addition to
successful
f ly conducting and completing the RedeS and ReCePI studi
t
es, we also understand that an additional Phase 3 clinical trial
including chronic anemia subj
u ects, in vitro studi
t
es, and other necessary activities will be required to be successfully completed and
subm
u
itted to the FDA before the FDA will consider our red blood cell product for
f
approval.
Additional infor
f
mation regarding our interactions with the FDA, our application for
f
a CE Certificate of Confor
f
mity in the European
Union for
f
the red blood cell system, and potential future clinical development of the INTERCEPT Blood System in Europe and in the
U.S. can be found
f
under “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K, under the risk factors titled “Clinical trials a
l
re
costly and time consuming, may t
a
ake l
k
onger than we expect or may n
a
ot be completed at all, and their outcomes are uncertain. A failure
to generate data in clinical trials to suppor
u
t exp
e
anded label claims or to support marke
r
ting appr
a
ovals o
l
r certific
i
ation for
f
our product
candidates could materially and adverse
r
ly affe
f ct our business, financial condition, results of operations and growth prospe
s
cts”
t
and
“The red blood cell sys
s
tem is c
i
urrently in development and may n
a
ever receive any market
k ing appr
a
ovals o
l
r CE C
C
er
C
tifi
i cates ofo
Confor
f
mity,”
y
as well as generally under the heading “Risks Related to Regulatory A
r
ppr
A
oval, C
l
E C
C
er
C
tificates of Confo
n rmity a
t
nd
Oversi
r ght
i
, a
t
nd Other Legal Compliance Mat
M ters.”
INTE
N
RCEP
E
T Blood System
t
Technology
o
Both our platelet system and plasma system employ the same technology. Platelet or plasma components collected from blood donors
are transferred into plastic INTERCEPT disposable kits and are mixed with our proprietary compound, amotosalen, a small molecule
compound that has an affinity for nucleic acid.
The disposable kits are then placed in an illumination device, or illuminator, where the mixture is exposed to ultra-violet A, or UVA,
light. If pathogens such as viruses, bacteria or parasites, as well as leukocytes, or white cells, are present in the platelet or plasma
components, the energy fro
f
m the UVA light causes the amotosalen to bond with the nucleic acid. Since platelets and plasma do not rely
on nucleic acid for
f
therapeutic effi
f cacy, the INTERCEPT Blood System is designed to preserve the therapeutic function of the platelet
and plasma components and IFC when used in human transfus
f
ions.
The abi
a lity of amotosalen to for
f
m both cross-links between strands of nucleic acid and links to single nucleic acid strands results in a
strong chemical bond between the amotosalen and the nucleic acid of the pathogens. The presence of these bonds is designed to prevent
replication of the nucleic acid within pathogens, effec
f
tively inactivating the pathogens. A high level of inactivation has been
demonstrated in a broad range of pathogens studi
t
ed by us and others in laboratory t
r
esting. For instance, INTERCEPT has demonstrated
inactivation of a number of single stranded nucleic acid-based viruses such as HIV, hepatitis B, hepatitis C (using a model virus
r
), West
Nile, chikungunya and certain influenza virus
r
es.
Following the inactivation process, residual amotosalen and by-products are reduc
d
ed by more than 99% through use of a compound
adsorption device, which is an integrated component of the disposable kit. We have performed extensive toxicology testing on the
residual amotosalen and its by-products and good safety margins have been demonstrated. Any remaining amotosalen which may be
transfus
f
ed, should any exist, is rapi
a dly excreted by humans.
Leukocytes, also known as white blood cells, are typically present in platelet and plasma components collected for transfusion and can
cause adverse transfusion reactions as well as an often fatal disease called graft-versus host disease. Leukocytes, like pathogens, rely on
nucleic acid for
f
replication and cellular func
f
tion. The INTERCEPT Blood System, with its combination of the amotosalen and UVA
light, is designed to inactivate leukocytes in the same manner it inactivates pathogens.
Like the platelet and plasma systems, the red blood cell system is designed to prevent pathogen replication by using a small molecule
additive compound to form bonds with nucleic acid in pathogens that may be present in donated red blood cell collections. The red
blood cell system is designed to preserve the therapeutic qualities of the red blood cells, which, like platelets and plasma, do not rely on
nucleic acid for their therape
a
utic effi
f cacy. The red blood cell system uses another of our proprietary compounds, amustaline. Unlike the
platelet and plasma systems, the chemical bonds from amustaline are not triggered by UVA light, but instead, by the pH level of the red
blood cell components. Afte
f r mixture with the red blood cell components in plastic disposable kits and resulting nucleic-acid bonding,
amustaline is designed to rapidly break down into a form that is no longer chemically reactive with nucleic acid. As with the platelet
and plasma systems, a high level of inactivation in a broad range of pathogens has been demonstrated with the red blood cell system in
the clinical setting. We plan on conducting additional pathogen-inactivation studies of the red blood cell system, broadening our
understanding of the pathogens the system may be able to inactivate.
By treating blood components with INTERCEPT within a day of collection, the inactivation of bacteria prevents bacterial growth that
could create increased risk of inflammatory response or dangerous levels of endotoxins. Extensive clinical testing has been done on
platelet and plasma products treated with the INTERCEPT Blood System, as well as post-marketing haemovigilance studies of the
treated blood products in routine use.
We believe that, due
d
to their mechanisms of action, the platelet system, plasma system, and red blood cell system will potentially
inactivate blood-borne pathogens that have not yet been tested with our systems, including emerging and fut
f ur
t
e threats to the blood
suppl
u
y. We do not claim, however, that our INTERCEPT Blood System will inactivate all pathogens, including prions or spores, and

10
our inactivation claims are limited to those contained in our product specifications. There can also be no assurance that INTERCEPT
will inactivate even those pathogens where claims exist, in every i
r
nstance or under every processing condition.
Manufac
f
turing and Supply
We have used, and intend to continue to use, third parties to manufact
f
ur
t
e and suppl
u
y the illuminators, components, disposable kits and
inactivation compounds that make up the INTERCEPT Blood System for use in clinical trials and for
f
commercialization. With the
exception of certain components, we rely solely on Fresenius Kabi AG, or Fresenius, for the manufac
f
ture of disposable kits for the
platelet and plasma systems. We rely on other contract manufact
f
ur
t
ers for
f
the production of our reagents, inactivation compounds,
compound adsorption components of the disposable kits, illuminators and other disposable kits or disposable accessories used in the
INTERCEPT Blood System. We currently do not have alternate manufact
f
ur
t
ers for
f
many of the components in our products or product
candidates beyond those that we rely on, but we are in the process of identifyi
f ng potential alternate manufact
f
ur
t
ers for
f
several
components, reagents and compounds. On May 2, 2022, we entered into the Second Amended and Restated Suppl
u
y and Manufact
f
ur
t
ing
Agreement, or the 2022 Agreement, with Fresenius Kabi AG, Fenwal France SAS, Fenwal International, Inc. and Fresenius Kabi
a
Deutschland GmbH, or collectively, Fresenius, for the manufact
f
ur
t
e and production of disposable sets for the INTERCEPT Blood System
until December 31, 2031. Under the terms of the 2022 Agreement, Fresenius is obligated to manufact
f
ur
t
e, and we are obligated to
purchase, finished disposable kits for the platelet and plasma systems. The 2022 Agreement permits us to purchase sets for
f
the platelet
and plasma systems from third parties to the extent necessary to maintain suppl
u
y qualific
f ations with such third parties or where local or
regional manufact
f
ur
t
ing is needed to obtain product registrations or sales. Fresenius will expand manufact
f
ur
t
ing of the disposable sets to
three production faci
f
lities, following qualific
f ation and licensure of such additional fac
f
ilities. The term of the 2022 Agreement will
automatically renew for
f
successive two-year periods unless terminated by either party upon two years’ prior written notice, in the case
of the initial term, or one year prior written notice, in the case of any successive renewal term. We and Fresenius each have normal and
customary t
r
ermination rights, including termination for
f
material breach. Pricing under the 2022 Agreement for
f
the initial term is based
on volume purchases by us and subject to an annual adjustment based on variation in a price index.
Components of the compound adsorption devices used in our platelet and plasma disposable kits are manufact
f
ur
t
ed by many third-parties,
including, Porex Corpor
r
ation, or Porex. In December 2024, we and Porex have entered into a second amended and restated
manufac
f
turing and supply agreement that became effec
f
tive January 1, 2025, or the 2025 Agreement, for the continued supply of the
compound adsorption devices. Porex is currently our sole suppl
u
ier for
f
compound adsorption devices. Under the 2025 Agreement, we
and Porex agreed to extend the term of the prior agreement until December 31, 2027. Under the terms of the 2025 Agreement, unit
pricing for
f
platelet wafers and plasma disks are set at certain amounts for
f
the fir
f st twenty-four months, starting January 1, 2025 with
volume based pricing after the fir
f st twenty-four months. Commercially viable alternatives, if ever availabl
a e, are likely several years
away.
We also have an amended and restated suppl
u
y agreement with Purolite LLC, for
f
merly Purolite Corporation, or Purolite, for
f
the supply
of raw materials used to make the compound adsorption devices. The amended supply agreement would have expired in April 2025,
however it has automatically renewed for
f
an additional year as neither party has delivered notice of its intent to terminate the agreement.
The agreement will continue to automatically renew for
f
one year periods unless either party provides notice not to renew at least two
years prior to the expiration. Under the terms of the amended agreement, pricing is volume based and is subject to annual, prospective
adju
d stments based on a Producer Price Index subject to an annual cap.
We have completed the manufac
f
turing for the current model of illuminator and maintain an inventory o
r
f those fin
f al devices. We have
subm
u
itted a new application for
f
confor
f
mity assessment to obtain a CE Certific
f ate of Confor
f
mity to affi
f x the CE Mark to a new
illuminator. In the U.S., we will be required to file
f
a new PMA for
f
our INTERCEPT Blood System for both platelets and plasma for
f
use
with our new illuminator. Although data is still being developed for
f
the required PMAs, we have completed the redesign of the new
illuminator. If we successful
f ly generate the data required for
f
the new PMAs, we cannot predict when, if ever, we will receive app
a
roval
for use of the platelet and plasma systems with the new illuminator. Until such time as we obtain appr
a
oval for
f
the redesigned illuminator,
if ever, the demand for illuminators may be higher than the remaining number of illuminators in inventory,
r
resulting in possible customer
allocations or loss of sales. We have contracts for
f
certain critical components and for the manufac
f
ture of our new illuminator. However,
we do not know if those agreements will be active when our new illuminator is approved, if ever.
We operate with an amended manufact
f
ur
t
ing and suppl
u
y agreement with Piramal, formerly, Ash Stevens, Inc., for
f
the synthesis of
amotosalen, the inactivation compound used in our platelet and plasma systems. Under this amended agreement, we are subject to
minimum annual purchase requirements. The term of the amended manufac
f
turing and supply agreement with Piramal automatically
renewed for
f
two years until December 31, 2025 and will continue to automatically renew for
f
successive two-year periods, unless
terminated by either party upon
u
providing at least one year prior written notice, in our case, or at least two years prior written notice, in
the case of Piramal. Neither party has delivered notice of its intent to terminate the agreement.
We and our contract manufac
f
turers purchase certain raw materials for our disposable kits, inactivation compounds, materials and parts
associated with compound adsorption devices and UVA illuminators fro
f
m a limited number of suppliers. Some of those raw material
suppl
u
iers require minimum annual purchase amounts. While we believe that there are alternative sources of supply for
f
such materials,
parts and devices, we have not validated or qualifie
f d any alternate manufac
f
turers. As such, establ
a ishing additional or replacement

11
suppl
u
iers for any of the raw materials, parts and devices, if required, will likely not be accomplished quickly and could involve significant
additional costs and potential regulatory r
r
eviews that could limit our ability to suppl
u
y customer demand.
Certain regions that we sell into or may sell into in the future may give priority to those products that are manufac
f
tured locally in their
jurisdiction. Our fai
f lure to meet these local manufact
f
ur
t
ing conditions may prevent us from successfully commercializing our product in
those geographies. In addition, should we choose to manufact
f
ur
t
e locally in those jurisdictions, we would likely incur additional costs,
may be unabl
a e to meet our quality system requirements or successfully manufac
f
ture products, and such activities will be a distraction
from our current focus and operations. We have limited experience managing local manufact
f
ur
t
ing or working with local manufac
f
turers
in geographies or jurisdictions outside of our existing manufact
f
ur
t
ing operations.
Marketing, Sales and Distribution
The market for
f
the INTERCEPT Blood System, including the U.S. market, is dominated by a relatively small number of blood collection
organizations. Accordingly, there may be an extended period during which some potential U.S.-based customers may fir
f st choose to
validate our technology or run experience studies themselves before deciding to adopt the system for
f
commercial use, which may never
occur. On October 1, 2021, all U.S. blood centers had to be compliant with the FDA guidance document, “Bacterial Risk Control
Strategies for Blood Collection Establishments and Transfus
f
ion Services to Enhance the Safety and Availability of Platelets for
f
Transfus
f
ion,” or the Final Guidance Document. Although the INTERCEPT Blood System is one of the options availabl
a e to U.S. blood
centers for compliance under the Final Guidance Document, we cannot predict if U.S. customers will continue to adopt INTERCEPT
over other options or at what levels.
The American Red Cross represents the largest single portion of the blood collection market in the U.S. and is one of our key customers.
While we believe adoption of the INTERCEPT Blood System affo
f
rds the American Red Cross with many benefits, we cannot guarantee
the volume or timing of commercial purchases that the American Red Cross may make.
The U.S. blood banking market is undergoing consolidation which may continue and fur
f
ther concentrate the potential customer base. In
many countries in Western Europe and in Japan, various national blood transfus
f
ion services or Red Cross organizations collect, store
and distribute virtually all of their respective nations’ blood and blood components supply. The largest European markets for
f
our
products are in Germany, France, and England.
In Germany, decisions on product adoption are made on a regional or blood center-by-blood center basis. While our obtaining a CE
Certific
f ate of Confor
f
mity permits us to affi
f x the CE Mark and sell the platelet and plasma systems to blood centers in Germany, blood
centers in Germany must still obtain both local manufact
f
ur
t
ing appr
a
oval and national marketing authorization fro
f
m the Paul Ehrlich
Institute, or PEI, a German governmental regulatory body overseeing the marketing authorization of certain medical produc
d
ts, befor
f
e
being allowed to sell platelet and plasma components treated with the INTERCEPT Blood System to transfus
f
ing hospitals and
physicians. To date, several blood centers in Germany have received such requisite approvals and authorizations for the platelet system.
Given the competitive natur
t
e of the German blood banking market, pricing for blood components is relatively low compared to other
markets. INTERCEPT-treated platelets received national reimbursement in Germany in 2018 at a premium to untreated platelets. While
this dynamic has the potential to generate economic value for
f
blood centers in Germany, we cannot ensure that blood centers will
understand or agree on any potential economic and logistical benefits of using INTERCEPT compared to conventional blood
components as well as the potential safet
f y benefit
f s of INTERCEPT-treated blood components. Following the inclusion of pathogen-
inactivated platelets for
f
national reimbursement by the German Institute for the Hospital Remuneration System as of January 1, 2018,
German customers who do not currently have an approved marketing authorization appl
a
ication, or MAA, will first need to obtain one
before using the INTERCEPT Blood System. The review period for a new MAA can be twelve months or longer fol
f lowing subm
u
ission
and we cannot predict which German customers or potential customers will obtain an MAA. Without broad appr
a
ovals of MAA
applications obtained by potential German customers, our ability to successful
f ly commercialize INTERCEPT in Germany will be
negatively impacted, which may adversely affect
f
the potential for
f
growth in that region. In addition, the reimbursement awarded to
INTERCEPT in Germany may not be considered by German blood centers as attractive enough to implement pathogen reduc
d
tion or
cover the entirety of their blood center platelet collections which may in turn limit the market acceptance in Germany. We do not yet
know if or how German blood centers plan to market and sell to their hospital customers nor do we have the abi
a lity to influence and
control implementation in hospitals in Germany to administer pathogen-reduced platelets. Should German blood centers be ineffe
f ctive
in marketing and selling INTERCEPT-treated platelets or if hospitals object, or are slow implementing the steps needed to procure and
administer pathogen reduc
d
ed platelets, our market in Germany may be limited or be slow to realize acceptance.
In France, broad produc
d
t adoption is dependent on a central decision by the Établ
a issement Français du Sang, or EFS, a public
organization responsible for all collection, testing preparation and distribution of blood products in France. Our agreements with EFS
to suppl
u
y platelet disposable kits and plasma disposable kits will both expire in October 2025. We also have an agreement with EFS for
maintenance services for illuminators that will expire in October 2025. We are discussing new contract terms with EFS for
f
the supply
of platelet disposable kits, plasma disposable kits, and maintenance services for illuminators. We cannot provide any assurance that the
national deployment of INTERCEPT to treat platelets in France will be sustainabl
a e, or that we will be able to secure any subsequent
contracts with EFS or that the terms, including the pricing or committed volumes, if any, of any fut
f ur
t
e contract will be equivalent or
supe
u
rior to the terms under our current contracts. If we are unabl
a e to continue to successful
f ly suppor
u
t EFS’ national adoption of the

12
INTERCEPT Blood System for platelets, EFS’ use of the INTERCEPT Blood System for Plasma or the final commercial terms of any
subs
u
equent contract for platelet or plasma disposable kits are less fav
f
orable than the terms under our existing contracts, our financial
results may be adversely impacted.
In England, decisions on product adoption are centralized in the National Blood Service, or NHSBT, which collects, tests, processes
and supplies blood products to hospitals in England and North Wales. The National Blood Service has implemented bacterial detection
for platelets for several years. We do not know when, if ever, the NHBST will consider adoption of a product for
f
pathogen reduc
d
tion,
including INTERCEPT.
In Japa
a
n, the Japanese Red Cross controls a significant majority of blood centers and exerts a high degree of influence on the adoption
and use of blood safety measures. The Japa
a
nese Red Cross has been reviewing preclinical and clinical data on pathogen reduc
d
tion of
blood over a number of years and has yet to make a for
f
mal determination to adopt any pathogen reduc
d
tion approach. Before
f
the Japanese
Red Cross considers our products, we understand that we may need to complete certain product config
f uration changes, which may not
be economically or technologically feasible for us to complete.
The FDA has app
a
roved the INTERCEPT Blood System for Cryoprecipitation, which uses our plasma system to produce IFC for the
treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen defic
f iency and to produce the derivative
product, pathogen reduc
d
ed plasma, cryoprecipitate reduced. We have entered into manufac
f
turing agreements with certain blood centers
to produce IFC for us, though most of these agreements do not contain stated minimum manufact
f
ur
t
ing commitments of the blood
centers. In addition, we have entered into agreements with certain blood centers and blood center affiliate organizations to sell the
INTERCEPT Blood System for Cryoprecipitation. In order to successful
f ly commercialize IFC, we will need to generate commercial
use data in order to influence the market and sell directly to hospital users and blood center producers of cryoprecipitate. We do not
know if IFC will be perceived as clinically, operationally, or economically attractive to hospital customers or at what price, if any, or if
the investment needed to sell IFC will be sustainabl
a e. Should our sale of kits to produce IFC alienate our contracted manufact
f
ur
t
ing
partners, it may put pressure on the pricing for IFC in the marketplace or limit commercialization of IFC in the U.S. Furthermore, if our
contracted manufact
f
ur
t
ing partners do not produce IFC in suffic
f ient quantities, or at all, we may not be able to meet hospital or blood
center demand which would limit our commercial effo
f
rts and may impact customer perception of our reliability in the marketplace.
Market adoption of our products is affe
f cted by blood center and healthcare facility budgets and the availabi
a lity of coverage and adequate
reimbursement from governments, managed care payors, such as insurance companies, and/or other third parties. In many jurisdictions,
due to the struc
r
ture of the blood products industry,
r
we have little control over budget and reimbursement discussions, which generally
occur between blood centers, healthcare facilities such as hospitals, and national or regional ministries of health and private payors.
Even if a particular blood center is prepared to adopt the INTERCEPT Blood System, its hospital customers may not accept, may not
have resources to adopt new technologies, or may not have the budget to purchase INTERCEPT-treated blood products. Since blood
centers would likely not eliminate the practice of screening donors or testing blood for some pathogens prior to transfusion, even afte
f r
implementing our products, some blood centers may not be able to identify e
f
nough cost offs
f ets or hospital pricing increases to affo
f
rd to
purchase our products. Budgetary concerns may be fur
f
ther exacerba
r
ted by economic legislation in certain countries and by proposals
by legislators at both the federal and, in some cases, state levels, regulators, healthcare faci
f
lities and third-party payors to keep healthcare
costs down, which may limit the adoption of new technologies, including our products. In some jurisdictions, commercial use of our
products may not be covered by governmental or commercial third-party payors for
f
health care services and may never be covered.
Even if we received national reimbursement for our produc
d
ts, we may not be able to educ
d
ate adequate numbers of blood center customers
on the benefit
f s of changing their operating practices and produce INTERCEPT-treated platelets and plasma. In the U.S., we obtained
HCPCS reimbursement codes for
f
hospital outpa
t
tient billing and payment of INTERCEPT-treated platelets and plasma in 2015, and for
f
IFC and the derivative, pathogen-reduced plasma, cryoprecipitate reduced in 2021. We cannot guarantee that the HCPCS codes for
f
our
products will be assigned payment rates in amounts suffi
f cient to cover the cost of our products to hospital customers.
The costs and expenses incurred by the blood center related to donor blood are typically included in the price that the blood center
charges a hospital for
f
a unit of blood. Even afte
f r blood components treated with our products are appr
a
oved for
f
reimbursement by
governmental or commercial third-party payors, the costs and expenses specific to the INTERCEPT Blood System may not be directly
reimbursed, but instead may be incorpor
r
ated within the reimbursement structur
t
e for
f
medical procedures and/or products at the site of
patient care. Governmental or third-party payors may change reimbursement rates, year over year, or in reaction to submitted claims for
f
reimbursement of costs and expenses related to blood components treated with INTERCEPT. If the costs to the hospital for
f
INTERCEPT
processed blood products cannot be easily, readily, or ful
f ly incorporated into the existing reimbursement structur
t
e, or if reimbursement
rates are insufficient or decreased in any given year for blood components treated with INTERCEPT, hospital billing and/or
reimbursement for these products could be impacted, thus negatively impacting hospitals’ acceptance and uptake of our products.
We maintain a wholly-owned subs
u
idiary, Cerus
r
Europe B.V., headquartered in the Netherlands, which focuses its effo
f
rts on marketing
and selling the INTERCEPT Blood System in a number of countries in Europe, the CIS, the Middle East and selected countries in other
regions around the world. We have a small scientific
f
affa
f irs group in the U.S. and the Netherlands that suppor
u
ts our commercialization
effo
f
rts as well as hospital affai
f rs profes
f
sionals, to help educate hospitals and physicians on our products, clinical trial history and
publications. We have a small group of individuals to market and sell IFC in the U.S. We have a small number of employees focused

13
on servicing the markets in Asia-Pacific and Latin American regions and rely primarily on distributors to market and sell our produc
d
ts
in those regions.
In Februa
r
ry 2021, we entered into an Equity Joint Venture Contract with Shandong Zhongbaokang Medical Implements Co., Ltd., or
ZBK, to establ
a ish Cerus
r
Zhongbaokang (Shandong) Biomedical Co., LTD., which we refer
f
to as the JV, for the purpos
r
e of developing,
obtaining regulatory a
r
ppr
a
oval for
f
, and eventual manufactur
t
ing and commercialization of the INTERCEPT blood transfus
f
ion for
f
platelets
and red blood cells in the People’s Republic of China. We own 51% of equity in the JV. The JV will need to obtain regulatory a
r
ppr
a
oval
for the INTERCEPT Blood System for platelets and red blood cells before it can begin commercializing in China. In order to obtain that
regulatory a
r
ppr
a
oval, the JV may need to run additional clinical studi
t
es in China. We cannot assure you the JV will be successful
f
in
meeting the endpoint, once defin
f ed, or that it will ever receive regulatory a
r
ppr
a
oval.
We have entered into distribution agreements, generally on a geographically exclusive basis, with distributors in countries where we
have limited abilities to commercialize our products directly. In certain of these jurisdictions, we rely on these distributors to obtain any
necessary in-country regulatory approvals, in addition to marketing and selling the INTERCEPT Blood System, providing customer and
technical product support, maintaining inventories, and adhering to our quality system in all material respects, among other activities.
Selected areas where we have entered into geographically exclusive distribution agreements include but are not limited to certain
countries in the CIS, the Middle East, Latin America, and Southeast Asia. Our success in these regions is dependent on our ability to
suppor
u
t our distributors and our distributors’ ability to market and sell our products and to maintain and service customer accounts,
including technical service. Our distribution agreements meaningful
f ly contribute to our revenues. As such, declining performance or the
outright termination or loss of certain distributor relationships could harm our existing business, may impact our growth potential, and
could result in higher operating costs for us. As our distributors play a critical role in our commercialization efforts, we evaluate their
performance on an ongoing basis. As we continue to evaluate our distributors, we may take fur
f
ther actions in the fut
f ur
t
e which may have
an impact on our operating results. In the past, we have transitioned certain territories to new distribution partners who we felt were
capable of improved performance relative to their predecessors as well as transitioned some of these territories to a Cerus
r
direct option,
which we believed would provide us with better visibility into and control of sales execution. We may undertake similar changes in the
future. As a result, we may experience a decrease in the volume of INTERCEPT disposable kit sales for the impacted territories as
outgoing distribution partners sell through their disposable kit inventory.
r
In addition, any new distributors or our own direct sales for
f
ce
may require some time to develop the market with the same proficiency as previous distributors. We cannot provide assurance that any
such changes will achieve the same level of operations or profic
f iency as previous distributors.
Government Contracts
We operate directly under four
f
contracts with U.S. Federal Agencies, two with BARDA, one with the FDA, and another with the DoD.
Revenue from the cost reimbursement provisions under our BARDA and the FDA government contracts varies by year. A portion of
our government contract revenue is subject to obtaining approval on audited indirect costs or rates and is subject to termination of the
contract at the election of the U.S. government. Our ability to recognize revenue under our contract with DoD for
f
the development of
pathogen reduc
d
ed, lyophilized cryo
r
precipitate is based on the application of the cost-to-cost input method, which measures the extent of
progress towards completion based on the ratio of actua
t
l costs incurred to the total estimated costs. Revenue is recorded as a percentage
of the transaction price based on the extent of progress towards completion. In addition, U.S. government contracts typically contain
unfav
f
orable provisions and are subj
u ect to audit and modification by the government at its sole discretion. Generally, government
contracts, including our agreements with BARDA, the FDA, and the DoD, contain provisions permitting unilateral termination or
modification, in whole or in part, at the U.S. government’s convenience. See Note 2 in the Notes to Consolidated Financial Statements
under “It
“ em 15—Ex
—
hibits and Financial Sta
S tement Schedules—Fin
F ancial Sta
S tementst ” of this Annual Report on Form 10-K for
f
information on significant accounting policies related to our government contract revenue and other financial infor
f
mation for the years
ended December 31, 2024, 2023 and 2022. Further discussion of the fact
f
ors impacting our government contracts revenue and the related
impact on our ability to operate our business can be found under “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K, under
the risk fact
f
ors titled “A s
“
igni
g fi
i cant portion of t
o
he funding for the
t
development of t
o
he
t
red blood cell sys
s
tem has come and is expected to
continue to come from our BARDA a
D
greement, a
t
nd if BARDA w
D
ere to eliminate, reduce, delay,
a
or object to extension for fundi
f
ng of our
agreement, it would h
l
ave a signi
i
fic
i
ant, n
t
egative impact on our government contract revenues and cash flows,
w
and we may b
a
e for
f
ced to
suspend or terminate our U.S. red blood cell dev
d
elopment program or obtain alternative sources of funding” and “Unf
U av
f
orable
provisions in government contracts,
t
including in our contracts w
t
ith B
t
AR
B
DA, FDA
F
and DoD, may h
a
arm our business, financial condition
and operating results.”
Competition
Our products face a wide variety of competition from entities competing directly with alternative pathogen reduc
d
tion technologies for
platelets and/o
d r plasma, as well as from entities developing and selling blood screening products to detect and prevent contaminated
products from being transfus
f
ed, and from process and procedur
d
al decisions involving blood banking operations including but not limited
to shortened shelf-l
f ife o
f
f blood components. Many of our competitors have matur
t
e, well-established products or have other products
which are sold to U.S. based blood centers and many have more commercial resources than we do. In addition, competitors may choose
to seek a lower class of regulatory a
r
ppr
a
oval or certific
f ation than our products, which may be easier and less costly for them to maintain
and may be perceived as suffi
f cient by the marketpl
t ace. We believe that the INTERCEPT Blood System has certain competitive

14
advantages over competing blood-borne pathogen reduc
d
tion methods that are either on the market or known to us to be in development.
The INTERCEPT Blood System is designed for
f
use in blood centers, which allows for integration with current blood collection,
processing and storage procedur
d
es. Certain competing products currently on the market, such as solvent detergent-treated plasma, use
centralized processing that takes blood products away from the blood center in order to be treated at a central facility before being
shipped back out to the blood centers or hospitals for ultimate transfus
f
ion, which may result in higher costs.
Our INTERCEPT Blood System for
f
cryopr
r
ecipitation competes with traditional cryoprecipitate, a by-product of thawing frozen plasma
and with human plasma derived fib
f rinogen concentrates. While we believe that IFC has many advantages over competitors, conventional
cryopr
r
ecipitate and fib
f rinogen concentrates are well established within hospital use. Hospitals may not perceive the advantage of IFC
over the competing products, may perceive the cost of adopting IFC as prohibitive relative to its advantages or compared to competitive
products, we may be ineffe
f ctive in selling blood components directly to hospitals.
In Europe, several companies, including Grifol
f s, Octapha
a
rma AG, MacoPharma International and Kedrion Biopharma, are developing
or selling commercial pathogen reduc
d
tion systems or services to treat fre
f sh frozen plasma. Terumo BCT, a subsidiary of Terumo
Corporation, has developed a pathogen reduc
d
tion system for
f
blood products and has received a Class III CE Certific
f ate of Confor
f
mity
under the MDR and affi
f xed the CE Mark for such system for
f
both platelets and plasma and received Swissmedic appr
a
oval for
f
platelets
treated with their system. MacoPharma has received a CE Certific
f ate of Confor
f
mity for a UVC-based pathogen reduc
d
tion product for
f
platelets. MacoPharma completed a Phase 3 clinical trial in Germany to generate additional data for
f
possible expanded appr
a
ovals. We
understand that Terumo BCT also developed a pathogen reduc
d
tion system for
f
whole blood receiving a Class II CE Certific
f ate of
Confor
f
mity. Each of these companies’ products may offer
f
competitive advantages over our INTERCEPT Blood System.
In the U.S., INTERCEPT-treated plasma faces competition from Octapharma AG, which is currently commercializing treated fresh
frozen plasma for certain indications in the U.S. Our platelet product face
f
s competition fro
f
m a number of testing companies currently
approved for
f
the detection of pathogens including bacterial and viral pathogens in donated blood products and may face competition
from other technologies if approved. We are currently the only appr
a
oved pathogen reduc
d
tion product in the U.S. for platelets and
therefor
f
e subject to Department of Justice, or DOJ, anti-trus
r
t oversight.
Terumo BCT’s platelet, plasma or whole blood pathogen reduc
d
tion product may be viewed as favorable by the Japanese Red Cross.
Terumo Corporation is a large Japan-based, multinational corpo
r
ration with more mature products and relationships than we have. Our
ability to commercialize our products in certain markets, particularly in Japa
a
n, may be negatively affected by Terumo’s resources and
their pre-existing relationships with regulators and customers. Should Terum
r
o BCT’s product be appr
a
oved for
f
use and commercialized
in Japa
a
n, our products would likely directly compete against its products and we believe we would likely need to either establ
a ish
operations in Japa
a
n or partner with a local Japa
a
nese company.
We believe that the primary competitive factors in the market for pathogen reduc
d
tion of blood products include the breadth and
effe
f ctiveness of pathogen reduc
d
tion processes, the amount of demonstrated reduction in transfusion related adverse events subsequent
to adopting pathogen reduc
d
tion technology, robustness of treated blood components upon
u
transfus
f
ion, the scope and enfor
f
ceability of
patent or other proprietary rights, perceived product value relative to perceived risk, product supply, perceived ease of use, perception
of safety, efficacy and economics of pathogen reduc
d
tion systems, and marketing and sales capability. In addition, we believe the length
of time required for
f
products to be developed and to receive regulatory a
r
nd, in some cases, reimbursement approval are also important
competitive fac
f
tors. We believe that the INTERCEPT Blood System will compete fav
f
orably with respect to these factors, although there
can be no assurance that it will be able to do so. Our success will depend in part on our ability to educ
d
ate prospective customers of the
benefits of and need to adopt pathogen reduc
d
tion technology and specifically our system relative to other technologies, our ability to
obtain and retain regulatory approvals or certific
f ations for our products, and our ability to continue suppl
u
ying quality and effective
products to our customers and prospective customers.
Patents, Licenses and Proprietary Rights
Our commercial success will depend in part on our ability to obtain patents, to protect trade secrets, to operate without infringing upon
the proprietary rights of others and to prevent others fro
f
m infri
f nging on our proprietary rights. Our policy is to seek to protect our
proprietary position by, among other methods, fil
f ing U.S. and foreign patent appl
a
ications related to our proprietary technology,
inventions and improvements that are important to the development of our business. As of December 31, 2024, we owned 16 issued or
allowed U.S. patents and appr
a
oximately 166 issued or allowed for
f
eign patents related to the INTERCEPT Blood System. Our patents
expire at various dates between 2025 and 2042. Recent patent appl
a
ications will, if granted, result in patents with later expiration dates.
Due to the complexity of our products, we believe it is the protection afforded to our products by the portfol
f io of intellectua
t
l property
rights that best protect our proprietary s
r
ystem rather than any one particular patent or trade secret. Proprietary rights relating to our
planned and potential products will be protected fro
f
m unauthorized use by third parties only to the extent that they are covered by valid
and enfor
f
ceabl
a e patents or are effect
f
ively maintained as trade secrets. The laws of certain foreign countries do not protect our intellectua
t
l
property rights to the same extent as do the laws of the U.S.
Further discussion of the factors impacting our intellectua
t
l property and the related impact on our ability to operate our business can be
found under “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K, under the risk factor titled “We may n
a
ot be able to protect
our intellectual property o
t
r ope
o
rate our business without
t
infr
n inging intellectual property r
t
ight
g s o
t
f o
o
thers.
r ”

15
Seasonality
Our business is dependent on the marketing and commercialization of the INTERCEPT Blood System to customers such as blood banks,
hospitals, distributors and other health care providers that have a need for
f
a pathogen reduc
d
tion system to treat blood products for
transfus
f
ion. Since we have not experienced purchasing patterns fro
f
m our customers based on seasonal trends, we do not expect
seasonality to have a material effe
f ct on our business, although purchasing patterns and inventory l
r
evels can fluctuate.
Inventory Requirements and Product Return Rights
Our platelet and plasma disposable kits have received regulatory a
r
ppr
a
oval and certific
f ation for
f
shelf lives ranging from 12 to 24 months.
Our INTERCEPT Blood System for Cryoprecipitation has received regulatory a
r
ppr
a
oval and certification for
f
a shelf life of 12 months.
Although we have regulatory a
r
pp
a
roval and certific
f ation for
f
our products in most regions for up t
u
o a 24 month shelf life,
f
the FDA has
limited our platelet product to an 18 month shelf life. Illuminators and replacement parts do not have regulated expiration dates. We
own raw materials, work-in-process inventory f
r
or
f
certain components of INTERCEPT disposable kits, fin
f ished INTERCEPT disposable
kits, illuminators, and certain replacement parts for
f
our illuminators. Our supply chain for certain of these fin
f ished goods and separately,
components, held as work-in-process on our consolidated balance sheets, may potentially take over one year to sell or complete
production befor
f
e being utilized in finished disposable kits or illuminators. We maintain inventory b
r
ased on our current and fut
f ur
t
e sales
projections, and at each reporting period, we evaluate whether our work-in-process inventory w
r
ould be used for
f
production within the
next 12-month period and evaluate our finished units in order to sell to existing and prospective customers within the next 12-month
period. It is not customary f
r
or
f
our turnover cycle for fin
f ished inventory t
r
o exceed twelve months. Instead, we use our best judgment to
factor in lead times for
f
the production of our finished units to meet our current demands. Occasionally, we make last-time-buys of certain
components or raw materials when such components or raw materials are considered at risk of being discontinued which allows us to
ensure continuity of production and sufficient time to develop or identify,
f
qualify a
f
nd secure alternate raw materials or components.
Inventory i
r
s recorded at the lower of cost, determined on a first in, first out basis, or market value. We use judgment to analyze and
determine if the composition of our inventory i
r
s obsolete, slow-moving, or unsalable and fre
f quently review such determinations. We
rely on our direct sales team and distributors to provide accurate forecasts of sales in their territory. If our forecasts or those of our
distributors are inaccurate, we could face
f
backlog situations or conversely, may produce and carry an abundance of inventory t
r
hat would
consume cash fas
f
ter than we have currently planned. Generally, we write-down specifically identifie
f d unusable, expired, obsolete, slow-
moving, or known unsalable inventory t
r
hat has no alternative use to net realizable value in the period that it is first recognized, by using
a number of fact
f
ors, including product expiration dates, open and unful
f filled orders, and for
f
ecasted demands. Any write-down of our
inventory t
r
o net realizable value establishes a new cost basis that will be maintained even if certain circumstances suggest that the
inventory i
r
s recoverabl
a e in subsequent fiscal periods.
We sell the INTERCEPT Blood System directly to blood banks, hospitals, universities, and government agencies, as well as to
distributors in certain regions. Generally, our contracts with our customers do not provide for open retur
t
n rights, except within a
reasonabl
a e time afte
f r receipt of goods in the case of defec
f
tive or non-confor
f
ming product. We have also entered into agreements with
certain blood centers and blood center affi
f liate organizations to sell the INTERCEPT Blood System for Cryoprecipitation for their
production of IFC and sale to their hospital customers. We may encounter pricing challenges and competition between the direct to
hospital sales model and kit sale to blood center model. To the extent that our blood center manufact
f
ur
t
ing partners do not produce
sufficient quantities, or at all, we may choose to buy treated IFC fro
f
m other blood centers to meet demand from hospitals or other blood
centers that do not make IFC, which may negatively impact our gross profit and overall operating retur
t
ns.
Research and Development Expenses
A significant portion of our operating expenses is related to research and development, and we intend to maintain a balanced yet strong
commitment to our research and development efforts. As we look ahead, we anticipate that maintaining compliance with regulatory
r
requirements and obtaining potential PMA suppl
u
ements for the platelet and plasma systems or post market appr
a
oval requirements will
require subs
u
tantial continued investment in research and development activities, as will our ongoing clinical, development and chemistry
r
manufac
f
turing and control, or CMC, work for
f
our red blood cell system in Europe as well as our whole-blood initiative in collabor
a
ation
with the FDA and lyophilized IFC development initiative in collabor
a
ation with the DoD. In the U.S., we expect to incur research and
development expenses associated with pursuing a new PMA for both the platelet and plasma systems for use with the new LED-based
illuminator and licensure of the red blood cell system including the RedeS study,
t
an additional Phase 3 clinical trial including chronic
anemia subj
u ects, in vitro studi
t
es, and other activities necessary to pursue FDA approval of our red blood cell system. To the extent
availabl
a e, many of the U.S. red blood cell activities may be reimbursed by BARDA, though no guarantee can be made that our progress
will be satisfactory t
r
o BARDA or that funds will be availabl
a e to either BARDA or us. Similarly, most of our whole blood program is
expected to be reimbursed by the FDA, though no guarantee can be made that our progress will be satisfactory t
r
o the FDA or that funds
f
will be availabl
a e to the FDA or us. Our abi
a lity to receive fun
f
ding under our contract with DoD for
f
the development of pathogen reduc
d
ed,
lyophilized cryopr
r
ecipitate is based on achievement of milestones which cannot be guaranteed. If we are unabl
a e to achieve any of those
milestones, funding may be limited, delayed, less than expected, or non-existent for that particular milestone, which in all cases would
negatively impact our cash flo
f ws and fin
f ancial results. In addition, we plan to continue spending on new product development and
enhancements to our illumination device and next generation of our INTERCEPT Blood System kits, which may increase research and
development expenses. See Note 2 in the Notes to Consolidated Financial Statements under “Financial Statement Schedules—Financial

16
Statements” of this Annual Report on Form 10-K for
f
costs and expenses related to research and development, and other financial
information for
f
the years ended December 31, 2024, 2023 and 2022.
Government Regulation
We and our products are comprehensively regulated in the U.S. by the FDA and by comparabl
a e governmental authorities in other
jurisdictions.
We initially received a CE Certificate of Confor
f
mity in accordance with the MDD for our platelet system and separately for
f
our plasma
system in 2002 and 2006.
In December 2023, we received CE Certific
f ates of Confor
f
mity in accordance with the MDR to affi
f x the CE Mark to our platelet and
plasma systems. We must receive a separate CE Certific
f ate of Confor
f
mity in accordance with the MDR for the red blood cell system
and affix the related CE Mark to permit the product to be sold in the European Union and in other countries recognizing the CE Mark.
We filed our application for
f
a CE Certific
f ate of Confor
f
mity of the red blood cell system under the MDR in June 2021. In October 2024,
we announced the CBG, the Competent Authority for the red blood cell system, concluded that the data provided regarding the medicinal
product or active pharmaceutical ingredient of our MDR appl
a
ication were insuffi
f cient to support the proposed classification of the
impurity profile of the fin
f al product, necessitating the closure of our MDR appl
a
ication without an approval. In collabor
a
ation with TÜV-
SÜD, we are assessing strategies for
f
a potential new MDR application, including data to address the classification questions raised by
CBG. We cannot predict with certainty when, if ever, we will be able to satisfac
f
torily address CBG’s conclusions and as such cannot
predict if or when we will submit a new MDR appl
a
ication for
f
the red blood cell system and, if subm
u
itted, when a decision concerning
certification would occur. In addition, France, Switzerland, Germany, and Austria require separate approvals for INTERCEPT-treated
blood products.
The FDA regulates drugs
r
, medical devices and biologics under the Federal Food, Drug,
r
and Cosmetic Act and other laws, including, in
the case of biologics, the Publ
u ic Health Service Act. These laws and implementing regulations govern, among other things, the
development, testing, manufact
f
ur
t
ing, record keeping, storage, labe
a
ling, advertising, promotion and pre-market clearance or appr
a
oval of
products subj
u ect to regulation. The steps required befor
f
e a medical device may be appr
a
oved for
f
marketing in the U.S. pursuant to a PMA
include:
•
preclinical labor
a
atory a
r
nd animal tests;
•
subm
u
ission to the FDA of an investigational device exemption for
f
human clinical testing, which must become effe
f ctive
before human clinical trials may begin;
•
appropriate tests to show the product’s safet
f y;
•
adequate and well-controlled human clinical trials to establ
a ish the product’s safet
f y and effi
f cacy for its intended indications;
•
subm
u
ission to the FDA of a PMA; and
•
FDA review of the PMA in order to determine, among other things, whether the product is safe a
f
nd effe
f ctive for
f
its intended
uses.
The FDA has app
a
roved the platelet system for ex vivo preparation of pathogen-reduced apheresis platelet components in order to reduc
d
e
the risk of TTI, including sepsis, and as an alternative to gamma irradiation for
f
prevention of transfus
f
ion-associated graft v
f
ersus host
disease, or TA-GVHD. The FDA has also approved the plasma system for ex vivo preparation of pathogen-reduced, whole blood derived
or apheresis plasma in order to reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion and as an alternative
to gamma irradiation for
f
prevention of TA-GVHD. We have also received FDA approval for
f
the INTERCEPT Blood System for
Cryopr
r
ecipitation, which uses our plasma system to produce IFC for the treatment and control of bleeding, including massive
hemorrhage, associated with fibrinogen defic
f iency and to produce pathogen reduc
d
ed plasma, cryoprecipitate reduced. We plan to
conduct development activities, clinical studies and in vitro studi
t
es for our platelet system to expand our labe
a
l claims in the U.S.
As a condition to the FDA app
a
roval of the platelet system, we were required to conduct two post-approval studies of the platelet system
studi
t
es - a haemovigilance study to evaluate the incidence of acute lung inju
n ry following transfusion of INTERCEPT-treated platelets;
and a recovery study
t
of platelets treated with the platelet system. The haemovigilance study was completed, met its endpoint, and results
published in a peer-reviewed journal. We have also completed the recovery and survival study of the platelet system and have subm
u
itted
the data to the FDA. In addition to these studi
t
es, the FDA has also required us to perform many studi
t
es to suppor
u
t changes to our
products and to commit to perform other lengthy post-marketing studies, for
f
which we will have to expend significant additional
resources. In addition, there is a risk that post-approval studies will show results inconsistent with our previous studi
t
es.
Any modifications to the platelet and plasma systems that could significantly affe
f ct their safet
f y or effectiveness, including significant
design and manufact
f
ur
t
ing changes, or that would constitute a major change in their intended use, manufact
f
ur
t
e, design, components, or
technology requires FDA approval of a new PMA or PMA supplement. However, certain changes to a PMA-approved device do not
require subm
u
ission and app
a
roval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The

17
FDA requires every suppl
u
ier to make this determination in the first instance, but the FDA may review any suppl
u
ier’s decision. The FDA
may not agree with our decisions regarding whether new subm
u
issions or approvals are necessary. We will need to obtain new PMA
approvals for our platelet and plasma systems for
f
use with our new illumination device. We cannot predict whether or not we will be
successful
f
in generating the data required for
f
the new PMAs, or predict when, if ever, we will receive approval for
f
use of the platelet
and plasma systems with the new illuminator. Our products could be subject to recall if the FDA or other regulators determine, for any
reason, that our products are not safe or effe
f ctive or that appr
a
opriate regulatory s
r
ubmissions were not made. If new regulatory a
r
ppr
a
ovals
are required, this could delay or preclude our ability to market the modified system. Furthermore, in order to address the entire market
in the U.S., we will need to develop and test additional config
f urations of the platelet system, including making the platelet system
compatible with random donor platelets. Our fai
f lure to obtain FDA or foreign regulatory a
r
ppr
a
ovals of new platelet and plasma product
config
f urations could significantly limit product revenues fro
f
m sales of the platelet and plasma systems.
With FDA appr
a
oval of our platelet and plasma systems and the INTERCEPT Blood System for Cryoprecipitation, we are required to
continue to comply with applicable FDA and other regulatory r
r
equirements related to, among other things, labeling, packaging, storage,
advertising, promotion, record-keeping and reporting of safety and other information. In addition, our manufact
f
ur
t
ers and their fac
f
ilities
are required to comply with extensive FDA and for
f
eign regulatory a
r
uthority requirements, including, in the U.S., ensuring that quality
control and manufact
f
ur
t
ing procedures confor
f
m to FDA-mandated current Good Manufact
f
ur
t
ing Practice, or cGMP, and Quality System
Regulation, or QSR, requirements. As such, we and our contract manufac
f
turers are subject to continual review and periodic inspections.
The manufact
f
ur
t
ing fac
f
ility which produces our platelet and plasma systems was recently audited by the FDA. While there were not
objectionabl
a e conditions observed dur
d
ing the audit, the FDA or other regulatory a
r
uthorities and Notifie
f d Bodies may inspect and audit
facilities manufac
f
turing or products or components at any time. Complying with and resolving any audit fin
f dings may result in additional
costs, changes to our manufact
f
ur
t
ers quality management systems or both. Failure to timely resolve and comply to audit fin
f dings, if any,
may result in enfor
f
cement actions and may result in a disrupt
u ion to the suppl
u
y of our products. Accordingly, we and others with whom
we work must continue to expend time, money and effo
f
rt in all areas of regulatory c
r
ompliance, including manufact
f
ur
t
ing, production
and quality control. Similar requirements and considerations apply in the EU for our platelet and plasma systems that have been CE
Marked in accordance with the MDR.
We are also required to report certain adverse events and production problems, if any, to the FDA, competent authorities of the EU
Member States and Notifie
f d Bodies, and foreign regulatory a
r
uthorities, when applicable, and FDA, competent authorities of the EU
Member States, or other foreign regulatory a
r
uthorities may require us to recall products as a result of adverse events or production
problems. Additionally, we are required to comply with requirements concerning advertising and promotion for
f
our produc
d
ts. For
example, our promotional materials and training methods must comply with FDA and other appl
a
icable laws and regulations, including
the prohibition of the promotion of unappr
a
oved, or off-l
f
abel, uses. If the FDA, competent authorities of the EU Member States, or other
foreign regulatory a
r
uthorities determine that our promotional materials or training constitute promotion of an off-label use, they could
request that we modify our training or promotional materials or subj
u ect us to regulatory o
r
r enfor
f
cement actions, including the issuance
of an untitled letter, a warning letter, inju
n nction, seizure, civil fin
f e or criminal penalties. It is also possible that other federal, state,
competent authorities of the EU Member States, or for
f
eign authorities might take action if they consider our promotional or training
materials to constitute promotion of an off-label use, or a violation or any other fed
f
eral or state law that applies to us, such as laws
prohibiting false claims for
f
reimbursement. Although our policy is to refra
f in from statements that could be considered off-
f labe
a
l
promotion of our products, the FDA, competent authorities of the EU Member States, or another regulatory a
r
gency could disagree and
conclude that we have engaged in off-label promotion. In addition, the off-l
f abel use of our products may increase the risk of product
liabi
a lity claims. We are also subj
u ect to other broadly applicable fraud and abus
a
e and other healthcare laws and regulations, including
anti-kickba
k
ck, health care professional payment transparency, and health information privacy and security laws, which may constrain
the business or fin
f ancial arrangements and relationships through which we research, as well as, sell, market and distribute our produc
d
ts.
Any enfor
f
cement action brought by a federal, state or for
f
eign authority could result in significant civil, criminal and/or administrative
penalties, damages, fines, disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid,
inju
n nctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refus
f
al to allow us to
enter into government contracts, contractua
t
l damages, administrative burdens, diminished profits and fut
f ur
t
e earnings, additional
reporting requirements and/o
d r oversight if we become subj
u ect to a corporate integrity agreement or similar agreement. In addition, our
reputation could be damaged and adoption of the products could be impaired. Further discussion of the health care laws and regulations
that may affect
f
our can be found in “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K, under the risk factor titled: “We are
subject to federal, state and foreign l
g
aws g
w
overning our business practices which, if violated, c
d
ould result in substantial penalties and
harm our reput
e
ation and business.”
CBER is the center within the FDA principally responsible for regulating the INTERCEPT Blood System. In addition to regulating our
blood safety products, CBER also regulates the blood collection centers and would regulate any blood products that they prepare using
the INTERCEPT Blood System. Many U.S.-based blood centers have completed and obtained site-specific licenses from
f
CBER that
allows them to make INTERCEPT-treated blood products availabl
a e to their interstate hospital customers. Any significant product change
that we make may require amendments or suppl
u
ements to those site-specific licenses that could limit availabi
a lity of INTERCEPT-treated
blood products until the amendment or suppl
u
ement is appr
a
oved. Additionally, hospital customers of ours or of any of our blood center
customers may need to go through the administrative process of generating internal tracking codes to integrate INTERCEPT-treated
products into their inventories or may need to amend or adjust those codes in connection with a significant product change that we make,

18
which may adversely impact our ability to sell products in the U.S. Increasingly, the competent authorities of other countries are also
developing equivalent rules and obligations.
We suppl
u
y the INTERCEPT Blood System for Cryoprecipitation to select blood centers that manufact
f
ur
t
e IFC for us. We also sell the
finished IFC made by our manufactur
t
ing blood center partners directly to hospitals and in some cases, other blood centers. Similar to
our platelet and plasma products, any blood center manufact
f
ur
t
ing IFC will need to complete their process validations and obtain site-
specific licenses fro
f
m CBER befor
f
e we or they can sell finished IFC to hospital customers outside of the states producing IFC. While
all of our manufactur
t
ing partners have received a BLA fro
f
m CBER, we plan to continue working with any other U.S.-based blood
centers producing IFC to suppo
u
rt their licensure applications and any delay in obtaining these licenses would adversely impact the
nationwide availability of our finished IFC in the U.S. Furthermore, most of our agreements with blood center manufac
f
turing partners
do not contain minimum production requirements. If our blood center manufact
f
ur
t
ing partners do not produce suffi
f cient quantities of
IFC, or at all, our commercialization effor
f
ts will be negatively impacted. In late 2023, we learned that Octapharma fil
f ed a complaint
against the FDA regarding BLAs received by our manufact
f
ur
t
ing partners. While we understand that the complaint has been settled, it
has and may continue slowing the licensure of additional BLAs. In addition, we have entered into certain agreements with blood centers
and blood center affi
f liate organizations to sell the INTERCEPT Blood System for Cryoprecipitation kits which will allow those blood
centers and blood center affilia
f
te organizations to produce fin
f ished IFC for their own sales effo
f
rts to hospitals.
We believe that in deciding whether the INTERCEPT Blood System is safe and effective regulatory a
r
uthorities have taken, and are
expected to take, into account whether it adversely affects the therapeutic effi
f cacy of blood components as compared to the therapeutic
effi
f cacy of blood components not treated with INTERCEPT. Data from human clinical studi
t
es must demonstrate the safety of treated
blood components and their therape
a
utic comparability to untreated blood components. In addition, regulatory a
r
uthorities will weigh
INTERCEPT’s safety, including potential toxicities of the inactivation compounds, and other risks against the benefits of using the
system in a blood suppl
u
y that has become safer. We have conducted many toxicology studi
t
es designed to demonstrate the INTERCEPT
Blood System’s safety. There can be no assurance that regulatory a
r
uthorities will not require further toxicology or other studies of our
products. As an example, a consultation of additional substances contained within the INTERCEPT RBC Processing Set (Processing
Solution and SAG-M Storage Solution) was required and ultimately determined to not suppor
u
t licensure of our application for
f
CE Mark
approval. Should we be required to generate data for
f
these ancillary solutions, our resubm
u
ission of our application for
f
CE Mark approval
and an eventua
t
l appr
a
oval decision may be delayed or not be received at all. Based on discussions with the FDA and European Union
regulatory a
r
uthorities, we believe that data only fro
f
m laboratory a
r
nd animal studies, not data from human clinical studi
t
es, will be required
to demonstrate the system’s effi
f cacy in reducing pathogens. In light of these criteria, our clinical trial programs for
f
the INTERCEPT
Blood System consist of studies that differ fro
f
m typical Phase 1, Phase 2 and Phase 3 clinical studi
t
es.
We have relatively little human or commercial use data suppor
u
ting our IFC product. Accordingly, prospective blood center
manufac
f
turing partners, hospitals or physicians may require additional commercially derived data befor
f
e choosing to use IFC. Such
studi
t
es may be costly and require the use of third-party clinical research organizations, or CROs, or data capture methods and may take
a considerable amount of time to generate sufficient data befor
f
e we can achieve broad market acceptance, if ever.
We may be subject to diverse laws and regulations relating to data privacy and security as a result of our employee data or other personal
information that we may collect. In addition, if we do collect personal data as part of any clinical trials or other testing, we would be
subj
u ect to regulatory o
r
bligations. This includes, in the U.S., the Califor
f
nia Consumer Privacy Act of 2018, or CCPA, in the European
Economic Area, or EEA, the EU General Data Protection Regulation, or GDPR (Regulation 2016/679) and the related national rul
r es of
the individual EEA countries, and in the United Kingdom, or UK, the UK GDPR. New privacy rules are being enacted in the U.S. and
globally, and existing ones are being expanded, updated and strengthened. Foreign data privacy and security laws (including but not
limited to the EU GDPR and UK GDPR) impose significant and complex compliance obligations on entities that are subj
u ect to those
laws. As one example, the EU GDPR app
a
lies to any company established in the EEA and to companies establ
a ished outside the EEA that
process personal data in connection with the offering of goods or services to data subj
u ects in the EEA or the monitoring of the behavior
of data subj
u ects in the EEA. These obligations may include limiting personal data processing to only what is necessary f
r
or
f
specified,
explicit, and legitimate purpos
r
es; requiring a legal basis for
f
personal data processing; requiring the appoi
a
ntment of a data protection
offi
f cer in certain circumstances; limiting the collection and retention of personal data; increasing rights for
f
data subj
u ects; formalizing a
heightened and codified standard of data subj
u ect consents; requiring the implementation and maintenance of technical and organizational
safeguards for
f
personal data; mandating notice of certain personal data breaches to the relevant supervisory a
r
uthority(ies) and affe
f cted
individuals; and mandating the appointment of representatives in the UK and/or the EU in certain circumstances.
Other states have enacted data privacy laws. For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the
Colorado Privacy Act, both of which differ fro
f
m the CCPA and became effective in 2023.
Also, in June 2018, the State of Califor
f
nia enacted the CCPA, which became effective in January 2020. The CCPA establishes a privacy
framework for covered businesses, including an expansive defin
f ition of personal infor
f
mation and data privacy rights for
f
Califor
f
nia
residents. The CCPA includes a framework with potentially severe statut
t ory d
r
amages and private rights of action. The CCPA requires
covered companies to provide new disclosures to Califor
f
nia consumers (as that word is broadly defin
f ed in the CCPA), provide such
consumers new ways to opt-out of certain sales of personal infor
f
mation, and allow for
f
a new cause of action for
f
data breaches.

19
Further, California voters appr
a
oved a new privacy law, the Califor
f
nia Privacy Rights Act, or CPRA,
R
in the November 3, 2020, election.
Effe
f ctive starting on January 1, 2023, the CPRA s
R
ignificantly modifies the CCPA, including by expanding consumers’ rights with
respect to certain sensitive personal infor
f
mation. The CPRA a
R
lso creates a new state agency that will be vested with authority to
implement and enfor
f
ce the CCPA and the CPRA.
R
Further discussion of our regulatory a
r
nd clinical trial status can be found in “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form
10-K, under the risk factors titled “Clinical trials are costly and time consuming, may t
a
ake l
k
onger than we expect or may n
a
ot be
completed at all, and their outcomes are uncertain. A failure to generate data in clinical trials to suppor
u
t exp
e
anded label claims or to
suppor
u
t marke
r
ting appr
a
ovals o
l
r certific
i
ation for
f
our product candidates could materially and adverse
r
ly affe
f ct our business, financial
condition, results of operations and growth prospe
s
cts”
t
and “The red blood cell sys
s
tem is c
i
urrently in development and may n
a
ever
receive any market
k ing appr
a
ovals o
l
r CE C
C
er
C
tificates of Confor
f
mity,”
y
as well as generally under the heading “Risks Related to Regulatory
r
Appr
p
oval, C
l
E C
C
er
C
tificates of Confor
f
mity and Oversi
r ght
i
, a
t
nd Other Legal Compliance Mat
M ters.”
U.S. Health Care Reimbursement and Refor
f
m
Our abi
a lity to commercialize our products successful
f ly in the U.S. will depend in part on the extent to which coverage and appr
a
opriate
reimbursement levels for the cost of the products and related treatment are obtained. The INTERCEPT Blood System is currently sold
to U.S. based blood collection entities. Because our INTERCEPT processing kits are not directly reimbursabl
a e by governmental or
commercial third-party payors, adoption of the INTERCEPT Blood System will, in part, require coverage and adequate reimbursement
to be provided for
f
the procedures and treatments which utilize INTERCEPT-processed blood products. There is no uniform policy of
coverage and reimbursement among third-party payors, as such, coverage and reimbursement can differ significantly from payor to
payor. Even if fav
f
orable coverage and reimbursement status
t
is attained for a particular procedur
d
e or treatment, less fav
f
orable coverage
policies and reimbursement rates may be implemented in the future. If the costs to hospitals for INTERCEPT-processed blood products
acquired fro
f
m blood collection entities cannot be easily, readily, or ful
f ly incorporated into the hospital’s existing coverage and
reimbursement structur
t
e, adoption of our products may be negatively affected.
In the U.S., there have been a number of legislative and regulatory c
r
hanges to the healthcare system that could affect our future results
of operations. For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation
Act, or collectively, the ACA, and ongoing cost saving effo
f
rts may have an impact on our ability to profita
f
bl
a y commercialize the
INTERCEPT Blood System in the U.S. and elsewhere. The ACA and other health care refor
f
m in the U.S. include provisions that place
downward pressure on the pricing of medical products, which could fur
f
ther impact our profit
f
margins.
Since its enactment, there have been amendments and judicial and Congressional challenges to numerous provisions of the ACA. For
example, on August 16, 2022, the Infla
f tion Reduc
d
tion Act of 2022, or IRA,
R
was signed into law, which among other things, extends
enhanced subs
u
idies for
f
individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also
eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary m
r
aximum
out-of-pocket cost and creating a new manufact
f
ur
t
er discount program. It is possible that the ACA will be subj
u ect to judicial or
Congressional challenges in the future. It is unclear how any such challenges and the health care refor
f
m measures of the second Trum
r
p
administration will impact the ACA.
In addition, there has been heightened governmental scrutiny to control the rising cost of healthcare. For example, such scrutiny has
resulted in several recent congressional inquiries, presidential executive orders, and fed
f
eral and state legislative activity designed to,
among other things, bring more transparency to pricing and reform government program reimbursement methodologies for
pharmaceutical products.
Further discussion of the impact of health care refor
f
m and laws governing our business practices on our business can be found in “Item
1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K, under the risk factors titled “Le
“
gi
e sl
i ative, regu
e
latory, o
y
r other healthcare
refo
e rms may make it more diffic
i
ult and costly for us to obtain regulatory a
r
ppr
a
oval or CE Certificates of Confor
f
mity of our products and
to produce, market
k
and dist
i ribute our products afte
f r appr
a
oval or certific
f ation is o
i
btained” and “We a
W
re subject to fed
f
er
d
al, s
l
tate and
foreign l
g
aws g
w
overning our business practices which, if violated, c
d
ould result in substantial penalties and harm our reput
e
ation and
business.”
Human Capital
As of December 31, 2024, we had 281 employees representing at least 38 nationalities which includes 7 dedicated commercial
consultants. Approximately 62% of our global employees are women. In addition, of our U.S. employees, appr
a
oximately 50% identify
f
as non-white.
Below is additional demographic infor
f
mation about our current employee base as of December 31, 2024.
Cerus Employees
2024
Salaried workforce
267
Managers and abo
a
ve
73
Part-time employees
16

20
Average age
46.6 years
Average length of service in years
6.5 years
Employee tur
t
nover rate December 31, 2023 to 2024 (voluntary)
r
8.3%
Our employees are a key fac
f
tor in our ability to serve our customers and achieve our mission to establ
a ish INTERCEPT as the standard
of care for
f
transfus
f
ed blood components globally and to enabl
a e our customers to do everything in their power to deliver safe and effective
blood products to patients. The ability to hire and retain highly skilled profes
f
sionals remains key to our success in the marketpl
t ace. To
attract, maintain and motivate our employees, we offer a challenging work environment, ongoing skills development initiatives,
attractive career advancement, opportunities and a culture that rewards entrepreneurial initiative and execution. Our guiding principles
of integrity, perseverance, scientific
f
rigor, and urgency are core to who we are and serve as the founda
f
tion of our values. Our guiding
principles set the tone for how we work together and provide a fra
f mework for giving feed
f
ba
d
ck. Service is at the core of our business
and our interactions with one another.
Compensation and Benefi
e ts
i
We strive to provide pay, benefits, and services that are competitive with local markets and create incentives to attract and retain
employees across the globe. Our compensation package includes market-competitive pay, broad-based stock grants and bonuses, health
care and retirement benefits
f
, paid time off,
f
paid parental leave, tuition reimbursement, among others.
Cerus encourages employees to become involved in their community by volunteering for
f
activities that enhance and serve the
communities in which they live and work. Our employees receive a Volunteer Paid Time Off P
f
rogram allowing employees to get paid
for volunteering at a charity of their choice. We also partnered with LinkedIn to provide unlimited access to LinkedIn Learning, a robust
online training platfor
f
m providing employees with continuous learning opportunities. In 2024, we implemented learning paths within
the LinkedIn Learning platform, to drive more specialized and foc
f
used development for
f
all employees.
Hybrid Workfo
k
rce
Beyond providing offi
f ces and infrastructur
t
e for
f
our employees to work, we also allow for
f
remote work and have adopted a hybrid
workpl
k ace policy. We allow fle
f xible schedul
d es, and suppor
u
t employee infor
f
mation technology needs. In addition, we have provided
training to employees and managers on how to work from home and how to manage hybrid employees to ensure that our employees are
maintaining their physical, mental and emotional well-being.
Communication and Engagement
We strongly believe that Cerus’ success depends on employees understanding how their work contributes to our overall strategy. To
this end, we utilize a variety of channels to facilitate open and direct communication, including: (i) periodic CEO update emails; (ii)
open for
f
um
r
s or All Hands Meetings with executives and other leaders; and (iii) regular ongoing update communications.
Health
l
, Wel
W ln
l
ess and Safe
a ty
We are committed to the safety of our employees and communities, from laboratory o
r
perations to product development to supplier
partnerships. Our goal is to achieve zero serious inju
n ries through continued investment in and foc
f
us on our core safety programs and
inju
n ry-reduction initiatives. We provide access to a variety of innovative, fle
f xible, and convenient health and wellness tools, including
flu shots, an onsite gym for our Concord based employees and gym membership reimbursement for all of our global employees.
Available Infor
f
mation
We maintain a website at www.cerus.com. We make availabl
a e fre
f e of charge on or through our website our annual report on Form 10-
K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or fur
f
nished pursuant to Section
13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, or Exchange Act, as soon as reasonabl
a y practicable afte
f r we
electronically file such material with, or fur
f
nish it to, the Securities Exchange Commission. Information contained on or accessible
through our websites is not incorporated into, and does not form a part of, this Annual Report on Form 10-K or any other report or
document we file
f
with the SEC, and any refer
f ences to our websites are intended to be inactive textual references only.
Financial Infor
f
mation
Our fin
f ancial information including our consolidated balance sheets, consolidated statements of operations, consolidated statements of
comprehensive loss, consolidated statements of stockholders’ equity, consolidated statements of cash flo
f ws, and the related footnotes
thereto, can be found
f
under “Financial Sta
S tement Schedules” in Part IV of this Annual Report on Form 10-K.

21
Item 1A. Risk
i
Factor
t
sr
Our business fac
f
es signi
i
fi
i cant risk
i
s.
k
If any of the events or circumstances described in the following risk
i
s a
k
ctually occurs, our business
may s
a
uffe
f r, the trading price of o
o
ur common stock could decline and our financial condition or results of operations could be harmed.
These risks should be read in conjunction with the other info
n rmation set forth in this a
i
nnual repor
e
t on For
F
m 10-K. The risks and
uncertainties described below are not the only o
l
nes fac
f
ing us. There may be additional risk
i
s f
k
ac
f
ed by our business. Othe
t
r events that
we do not currently anticipate or that
t
we currently deem immaterial also
l
may a
a
dverse
r
ly affe
f ct our financial condition or results of
operations.
Risks Related to Our Business and Industry
We depe
e
nd substantia
t lly u
l
po
u
n the
t
commercial success of t
o
he
t
INTE
N
RCEP
E
T Blood System
t
for platelets, p
s
lasma and cryo
r
pr
o
ecipitation
in the U.S
U
.,
S and our inability t
t
o s
t
uccessfu
s
lly c
l
ommercialize the
t
INTE
N
RCEP
E
T Blood System
t
in the U.S
U
. w
S
ould have a mater
t
ial adverse
r
effe
f ct on our business, fina
i
ncial conditio
i
n, results o
t
f o
o
pe
o
rations and growth prospe
s
cts.
t
Our business is dependent on our ability to grow and sustain commercialization of the INTERCEPT Blood System for platelets, plasma,
and cryoprecipitation in the U.S. Significant product revenue from customers in the U.S. may not occur consistently, if at all, if we are
unabl
a e to demonstrate that our products are economical, safe a
f
nd effi
f cacious for potential customers. Similar to our experience in foreign
jurisdictions, some potential customers in the U.S. have chosen to first validate our technology or conduct other pre-adoption activities
prior to purchasing or deciding whether to adopt the INTERCEPT Blood System for commercial use, which may never occur. Further,
new hospital customers of any of our blood center customers will need to go through the administrative process of generating internal
tracking codes to integrate INTERCEPT-treated products into their inventories, which may further delay customer adoption in the U.S.
These administrative processes necessary for implementation of INTERCEPT are fur
f
ther strained due to the staffing shortages seen
globally.
On October 1, 2021, all U.S. blood centers were required to be compliant with the FDA guidance document, “Bacterial Risk Control
Strategies for Blood Collection Establishments and Transfus
f
ion Services to Enhance the Safety and Availability of Platelets for
f
Transfus
f
ion,” or the Final Guidance Document. Although the INTERCEPT Blood System is one of the options availabl
a e to U.S. blood
centers for compliance with the Final Guidance Document, we cannot predict if U.S. customers will continue to adopt, increase use of
INTERCEPT, or sustain current levels of INTERCEPT adoption. If we are unabl
a e to successfully support the commercialization of our
platelet system to U.S. customers that have elected to use the INTERCEPT Blood System, then those customers may be required to
adopt competing products in order to comply with the Final Guidance Document. Further, upon
u
adoption, U.S. blood centers may be
required to change their historical operating practices to confor
f
m to our product specifications, or they or their hospital customers may
be required to elect more than one option under the Final Guidance Document in order to comply, or they or their hospital customers
may choose competing products to comply with the Final Guidance Document. We may be unabl
a e to subsequently convert blood centers
that chose competing products to the platelet system, which would limit our market potential. If we are not successful
f
in achieving broad
market adoption of the INTERCEPT Blood System in the U.S., we may never generate subs
u
tantial product revenue, and our business,
financial condition, results of operations and growth prospects would be materially and adversely affected.
In any event, our ability to successful
f ly commercialize the INTERCEPT Blood System for platelets, plasma, and IFC in the U.S. will
depend on our ability to:
•
achieve market acceptance and generate produc
d
t sales through execution of sales agreements on commercially reasonabl
a e
terms;
•
enter into and maintain sufficient manufact
f
ur
t
ing arrangements for
f
the U.S. market with our third-party suppliers;
•
suppor
u
t blood center manufact
f
ur
t
ing partners in obtaining Biologics License Application, or BLAs, for
f
the sale of
INTERCEPT-treated products into interstate commerce;
•
effe
f ctively create market demand for
f
the INTERCEPT Blood System through our educ
d
ation, marketing and sales activities;
•
hire, train, deploy, suppor
u
t and maintain a qualifie
f d U.S.-based commercial organization and field sales force;
•
expand the labeled indications of use for
f
the INTERCEPT Blood System and/or design, develop, test and obtain regulatory
r
approval or certific
f ation for
f
new product config
f urations;
•
comply with requirements establ
a ished by the FDA, including post-marketing requirements and labe
a
l restrictions; and
•
comply with other U.S. healthcare regulatory r
r
equirements.
In addition to the other risks described herein, our ability to successful
f ly commercialize the INTERCEPT Blood System for platelets,
plasma and IFC in the U.S. is subject to a number of risks and uncertainties, including those related to:

22
•
the impact of macroeconomic developments, such as general political, health and economic conditions, including escalating
trade tensions and the Ukraine-Russia conflic
f
t, economic slowdowns, recessions, infla
f tion, bank failures, rising interest
rates and tightening of credit markets on our business;
•
staffi
f ng shortages at blood centers, hospitals, study sites or suppliers;
•
the highly concentrated U.S. blood collection market that is dominated by a small number of blood collection organizations;
•
availabi
a lity of blood donors;
•
regulatory a
r
nd licensing requirements, including the FDA Center for Biologics Evaluation and Research, or CBER,
licensing processes and its BLA requirements, that U.S.-based blood centers are required to fol
f low in order to obtain and
maintain the required site-specific licenses to engage in interstate transport of blood components processed using the
INTERCEPT Blood System;
•
changed or increased regulatory restrictions or requirements;
•
our ability to meet regulatory r
r
equirements for
f
any changes to our products, including component composition,
manufac
f
turing process, and location;
•
the amount availabl
a e for
f
reimbursement pursuant to codes we have obtained under the Healthcare Common Procedur
d
e
Coding System, or HCPCS, and pricing for
f
outpa
t
tient use of INTERCEPT-treated blood components;
•
any supply or manufact
f
ur
t
ing problems or delays arising with any of our suppl
u
iers, many of whom are our sole qualifie
f d
suppl
u
iers for the particular product or component they manufact
f
ur
t
e, including the abi
a lity of our suppl
u
iers to maintain FDA
approval to manufact
f
ur
t
e the INTERCEPT Blood System and to comply with FDA-mandated current Good Manufac
f
turing
Practice, or cGMP, and Quality System Regulation, or QSR, requirements and foreign equivalents;
•
our and our suppl
u
iers ability to produce suffi
f cient quantity of product to meet the growing demand for our products;
•
any supply or manufact
f
ur
t
ing problems or delays arising from our customers third-party suppl
u
iers whose products are used
in combination and compliance with our produc
d
ts including customers third-party suppl
u
iers’ abi
a lity to maintain FDA
approval to manufact
f
ur
t
e the INTERCEPT Blood System and to comply with FDA-mandated cGMP and QSR requirements;
•
ability to contract with, maintain and add additional blood center manufact
f
ur
t
ers for
f
the production of IFC and for the
contracted blood center manufact
f
ur
t
ing partners to produce IFC at sufficient quantities and at acceptabl
a e quality levels or
for other blood centers to contract with us for the purchase of kits and to produce IFC for their own sales effort
f
s;
•
dependency upon
u
any third-party manufact
f
ur
t
er that suppl
u
ies products required by blood centers to process and store blood
components consistent with our approved specifications and claims, including but not limited to, apheresis collection
devices, disposable blood bags and reagents, and platelet additive solution, or PAS, including those third-party suppl
u
iers’
ability to maintain FDA or other regulatory a
r
ppr
a
ovals to manufact
f
ur
t
e their products and to comply with FDA-mandated
cGMP and QSR requirements and foreign equivalents;
•
our ability to obtain patents, protect trade secrets, prevent others fro
f
m infri
f nging on our proprietary rights, and operate
without infringing the proprietary rights of third parties;
•
existing and potential fut
f ur
t
e competitive threats, including complaints, litigation or other such disrupt
r
ive practices,
regardless of merit;
•
changes in healthcare laws and policy, including changes in requirements for
f
blood product coverage by U.S. federal
healthcare programs; and
•
acceptance of the INTERCEPT Blood System as safe, effec
f
tive and economical from the broad constituencies involved in
the healthcare system.
The INT
I
ERCEP
T
T Blood System
t
may n
a
ot achieve or be able t
l
o s
t
ustain broad market adoptio
t n.
In order to maintain or increase market adoption of the INTERCEPT Blood System and to increase market demand, we must address
issues and concerns from broad constitue
t
ncies involved in the healthcare system, from blood centers to patients, transfus
f
ing physicians,
key opinion leaders, hospitals, private and public sector payors, regulatory b
r
odies and public health authorities. We may be unabl
a e to
demonstrate to these constituencies that the INTERCEPT Blood System is safe, effective and economical or that the benefits
f
of using
the INTERCEPT Blood System products justify t
f
heir cost and/or outweigh their risks.
The use of the platelet system results in some processing loss of platelets. Despite having claims elsewhere for
f
use of INTERCEPT-
treated platelets up t
u
o seven days, we have not been able to satisfy t
f
he FDAs requirement to obtain a seven-day storage claim for
f
INTERCEPT-treated platelets. As a result, customers or prospective customers may adopt competing solutions if they perceive that:

23
•
the loss of platelets leads to increased costs, or the perception of increased costs for
f
our customers;
•
the use of our product in any way constrains the availabi
a lity of platelets due
d
to platelet loss;
•
our customers or prospective customers believe that the loss of platelets reduc
d
es the efficacy of the transfusabl
a e unit;
•
our process requires changes in blood center collection processes or clinical regimens to address platelet loss; or
•
our products may never receive approval for
f
storage of platelets beyond five days.
Additionally, existing customers may not believe they can justify a
f
ny perceived operational change or ineffi
f ciency either generally or
in conjunction with a blood component availabi
a lity shortage. This concern may be exacerba
r
ted dur
d
ing any blood shortage crisis, which
the U.S. is currently facing. Certain studies have indicated that transfusion of conventionally prepared platelets may yield higher post-
transfus
f
ion platelet counts (according to a measurement called “corrected count increment”) and may be more effective than transfusion
of INTERCEPT-treated platelets. Although certain other studies demonstrate that INTERCEPT-treated platelets retain therape
a
utic
function comparabl
a e to conventional platelets, prospective customers may choose not to adopt our platelet system due to considerations
relating to corrected count increment or other factors. In addition, while our platelet system is used outside of the U.S. to treat whole
blood derived, pooled buffy
f
-coat collected platelet units, the FDA does not currently allow buffy
f
-coat platelets and therefore our ability
to treat U.S. collected platelets is limited to those collected via aphe
a
resis. Given the current shortage of platelets in the U.S., hospitals
may not discriminate about which platelet products they receive, which may result in less demand for INTERCEPT-treated products
and therefore less urgency for
f
blood centers to adopt or increase INTERCEPT-treated platelets.
The INTERCEPT Blood System does not inactivate all known pathogens, which may limit its market adoption. For example, our
products have not been demonstrated to be effe
f ctive in the reduction of certain non-lipid-enveloped virus
r
es, including hepatitis A and
E virus
r
es, and human parvovirus B-19, due to the biology of these virus
r
es. Although we have shown high levels of reduc
d
tion of a broad
spectrum of lipid-enveloped virus
r
es, INTERCEPT’s inability to inactivate, or limited reduc
d
tion of certain non-lipid-enveloped virus
r
es
may negatively impact the decision to adopt by prospective customers. Similarly, although our products have been demonstrated to
effe
f ctively inactivate spore-forming bacteria, our products have not been shown to be effective in reduc
d
ing bacterial spores once form
f
ed.
Furthermore, due to limitations of detective tests, we cannot exclude that a suffi
f cient quantity of pathogen or pathogens beyond the
detection limits may still be present in active for
f
m, which could present a risk of infec
f
tion to the transfus
f
ed patient. Should INTERCEPT-
treated components contain detectabl
a e levels of pathogens afte
f r treatment, the effi
f cacy of INTERCEPT may be called into question,
whether or not any remaining pathogens are the result of INTERCEPT’s effi
f cacy, the limitations of testing methodologies or other
factors. Such uncertainties may limit the market adoption of our products.
We have conducted studies of our products in both in vitro and in vivo environments using well-establ
a ished tests that were accepted by
regulatory b
r
odies. However, we cannot be certain that the results of these in vitro and in vivo studi
t
es accurately predict the actua
t
l results
in humans in all cases. In addition, strains of infect
f
ious agents in living donors may be different from those strains commercially availabl
a e
or for which we have tested and for
f
which we have received appr
a
oval of the inactivation claims for our products. To the extent that
actua
t
l results in human patients diffe
f r, commercially availabl
a e or tested strains prove to be different, or customers or potential customers
perceive that actual results diffe
f r fro
f
m the results of our in vitro or in vivo testing, market acceptance of our produc
d
ts may be negatively
impacted.
If customers experience operational or technical problems with the use of INTERCEPT Blood System products, market acceptance may
be reduced or delayed. For example, if adverse events arise from incomplete reduction of pathogens, improper processing or user error,
or if testing of INTERCEPT-treated blood samples fai
f ls to reliabl
a y confir
f m pathogen reduc
d
tion, whether or not directly attributable to
the INTERCEPT Blood System, customers may refra
f in from purchasing our products. We have recently learned of instances where,
following treatment with INTERCEPT, mishandling of the treated blood components has introduced environmental bacterium. We must
help our blood center customers to remain vigilant or increase their vigilance in adopting best practices regarding blood component
handling. Failure to adequately address this risk may call into question the effi
f cacy of using pathogen reduc
d
tion. We must report safet
f y
events to regulatory a
r
uthorities, regardless of the imputability of our products.
Furthermore, should customers communicate operational problems or suspected product fai
f lure, we will need to investigate and report
imputability to the relevant regulatory a
r
uthorities in a timely manner. We or others may be required to file
f
reports on such complaints
or product fai
f lure before we have the abi
a lity to obtain conclusive data as to imputability which may cause concern with existing and
prospective customers or regulators. Hospital or other blood center customers may purchase IFC as a biologic fro
f
m us or other blood
centers which would be produced by blood center manufact
f
ur
t
ing partners of ours or another blood center. Should we receive product
complaints on the produced IFC product, we may not be able to determine if a problem exists, or fro
f
m where the problem originated.
Should customers feel that INTERCEPT treatment has a negative impact on the number of transfusabl
a e platelet units able to be
manufac
f
tured fro
f
m available donors, our ability to educ
d
ate a blood center on the benefit
f s of treating increasing proportions of its platelet
units may be negatively impacted. Moreover, there is a risk that further studies that we or others may conduct will show results
inconsistent with previous studi
t
es. Should this happen, potential customers may delay or choose not to adopt our products and existing
customers may cease using our products. In addition, some hospitals may decide to purchase and transfus
f
e both INTERCEPT-treated
blood components and conventional blood components, including IFC which we have very l
r
imited experience selling directly to

24
hospitals. Managing such a dual inventory of blood products may be challenging, and hospitals may need to amend their product labels
and inventory m
r
anagement systems before being abl
a e to move forward with INTERCEPT. Hospitals may not have adequate staffi
f ng
levels or may have competing priorities which could delay such system updates, perhaps indefinitely. Similarly, blood centers may have
staffi
f ng or budgetary constraints or have competing priorities which may delay adoption of our products, including onboarding or
producing IFC. Management of complex inventories may require coordination between hospital suppliers, blood centers, or us, which
in turn may cause delays in market adoption. In addition, customers may require certain changes to our products for any number of
reasons. Complying with such requests may prove costly, and may create complexities surrounding the manufact
f
ur
t
ing of disposable
kits, compliance with regulatory a
r
uthorities, blood center usage, or inventory m
r
anagement. Conversely, failure to comply with such
requests fro
f
m customers may result in damage to our relationship or the potential loss of customer business.
Market adoption of our products is also affe
f cted by blood center and healthcare facility budgets and the availabi
a lity of coverage and
adequate reimbursement from governments, managed care payors, such as insurance companies, and/or other third parties. In many
jurisdictions, due
d
to the struc
r
ture of the blood products industry,
r
we have little control over budget and reimbursement discussions,
which generally occur between blood centers, healthcare fac
f
ilities such as hospitals, and national or regional ministries of health and
private payors. Even if a particular blood center is prepared to adopt the INTERCEPT Blood System, its hospital customers may not
accept or may not have the budget to purchase INTERCEPT-treated blood products. Since blood centers would likely not eliminate the
practice of screening donors or testing blood for some pathogens prior to transfusion, even afte
f r implementing our products, some blood
centers may not be able to identify e
f
nough cost offs
f ets or hospital pricing increases to affo
f
rd to purchase our products. Budgetary
concerns may be fur
f
ther exacerba
r
ted by economic legislation in certain countries and by proposals by legislators at both the federal and,
in some cases, state levels, regulators, healthcare facilities and third-party payors to keep healthcare costs down, which may limit the
adoption or continued use of technologies, including our produc
d
ts. In some jurisdictions, commercial use of our products may not be
covered by governmental or commercial third-party payors for
f
health care services and may never be covered. In addition, the costs and
expenses incurred by the blood center related to donor blood are typically included in the price that the blood center charges a hospital
for a unit of blood. Even afte
f r blood components treated with our products are appr
a
oved for
f
reimbursement by governmental or
commercial third-party payors, the costs and expenses specific to the INTERCEPT Blood System will not be directly reimbursed, but
instead may be incorpor
r
ated within the reimbursement structur
t
e for
f
medical procedur
d
es and/or products at the site of patient care.
Governmental or third-party payors may change reimbursement rates, year-over-year, or in reaction to submitted claims for
f
reimbursement of costs and expenses related to blood components treated with INTERCEPT. If the costs to the hospital for
f
INTERCEPT
processed blood products cannot be easily, readily, or ful
f ly incorporated into the existing reimbursement structur
t
e, or if reimbursement
rates are insufficient or decreased in any given year for blood components treated with INTERCEPT, hospital billing and/or
reimbursement for these products could be impacted, thus negatively impacting hospitals’ acceptance and uptake of our products. In
addition, even if we are abl
a e to achieve market acceptance in the U.S. or newly commercialized markets, we have provided and may in
the fut
f ur
t
e provide adoption incentives which may negatively impact our reported sales.
We are expos
e
ed to risk
i
s a
k
ssociated
t
with
i
the highl
g
y c
l
oncentrated
t
market for the
t
INTE
N
RCEP
E
T Blood System
t
.
The market for
f
the INTERCEPT Blood System is highly concentrated with few customers, including ofte
f n-dominant regional or national
blood collection entities. Failure to effectively market, promote, distribute, price or sell our products to any of these customers could
significantly delay or even diminish potential product revenue in those geographies. Moreover, the market for
f
pathogen reduc
d
tion
systems in the U.S. is highly concentrated and dominated by a small number of blood collection organizations. In the U.S., the American
Red Cross represents the largest single portion of the blood collection market. Our abi
a lity to achieve and maintain significant market
penetration in the U.S. is largely dependent on utilization of INTERCEPT and distribution of INTERCEPT-treated blood components
by the American Red Cross. The American Red Cross is a large organization. Given the large relative size of the American Red Cross,
our resources may be inadequate to ful
f fill the American Red Cross’ and other customers’ demands, which could result in a loss of
product revenues or customer contracts, or both. We understand that the American Red Cross has competing priorities which are
currently preventing them fro
f
m producing IFC for their own accounts. Until the American Red Cross can produce IFC for their own
accounts, they will be dependent on us or other blood centers to supply IFC for sale to their accounts and our ability to source and
produce suffi
f cient IFC for the American Red Cross is limited. Furthermore, should the American Red Cross order our produc
d
ts on an
inconsistent basis, either by increasing or reducing overall utilization of the INTERCEPT Blood System or by building or depleting
inventory l
r
evels they hold, our results of operations will be diffic
f ult to predict and may fall short of investor expectations. The American
Red Cross or other customers may impose business continuity requirements or Environmental, Social and Governance requirements to
its suppl
u
iers. Should the American Red Cross or other customers impose such requirements to our business, we may be unabl
a e to satisfy
the requirements without significant disrupt
u ion to our operations and incurrence of costs, if at all.
In many countries in Western Europe and in Japan, various national blood transfus
f
ion services or Red Cross organizations collect, store
and distribute virtually all of their respective nations’ blood and blood components supply. In Europe, the largest markets for our
products are in Germany, France, and England. In Germany, decisions on product adoption are made on a regional or even blood center-
by-blood center basis, but depend on both local approvals and centralized regulatory a
r
ppr
a
ovals from the Paul Ehrlich Institute, or PEI.
Obtaining these approvals requires support and coordination fro
f
m local blood centers, and may take a significant period of time to
obtain, if ever. Product specifications that receive marketing authorization fro
f
m the PEI may differ fro
f
m product specifications that have
been adopted in other parts of the EU and other countries where we rely on CE Certificates of Confor
f
mity and the CE Mark, thereby

25
necessitating market specific modifications to the commercial product, which may not be economical or technically feasible for us.
Following the inclusion of pathogen-inactivated platelets for
f
national reimbursement by the German Institute for the Hospital
Remuneration System as of January 1, 2018, German customers who do not currently have an authorization will first need to obtain one
before using our products. The review period for a new authorization can be 12 months or longer fol
f lowing subm
u
ission and we cannot
assure that any of the potential German customers subm
u
itting a new appl
a
ication for
f
authorization will obtain it. We have invested in
subs
u
tantial commercial resources in Germany. Without approvals obtained by potential German customers, or willingness of hospitals
to seek reimbursement for pathogen-reduced platelets or for
f
insurers to subm
u
it for the approved incremental reimbursement for
pathogen-reduced platelets, our ability to successful
f ly commercialize INTERCEPT in Germany will be negatively impacted, which may
adversely affect our business, results of operations and fin
f ancial condition and we may never realize a return on the investments we
have made building out our commercial team in Germany. In addition, the reimbursement awarded to INTERCEPT in Germany may
not be considered by German blood centers as attractive enough to implement pathogen reduc
d
tion or cover the entirety of their blood
center platelet collections which may in turn limit the market acceptance in Germany. Similar to the U.S., German blood centers will
need to successful
f ly market and sell to their hospital customers and understand and assist with the steps that are needed at the hospital
level in Germany to administer pathogen-reduced platelets.
While we have entered into agreements with Établissement Français du S
d
ang, or EFS, to suppl
u
y illuminators, platelet and plasma
disposable kits, maintenance services for illuminators and ancillary pooling sets to EFS, we cannot provide any assurance that the
national deployment of the platelet system in France will be sustainabl
a e or that we will be able to secure any contracts subsequent to our
existing contract with EFS. If we are unabl
a e to continue to successful
f ly suppor
u
t EFS’ national adoption of the platelet system, EFS’ use
of the plasma system, our business, results of operations and fin
f ancial condition may be adversely impacted. Our contracts with EFS do
not contain purchase volume commitments and as such, it is challenging to forecast with precision the purchase levels and product
demand and ful
f fill EFS’ orders. Furthermore, EFS contracts are entered into as part of a public procurement process and generally
extend for multiple years with little ability to adju
d st pricing. Our operating margins may be negatively impacted should infla
f tion rise
faster than our contracted pricing. In addition, we understand that EFS is inspecting and testing samples of each lot that it purchases
from us prior to accepting the products shipped to ful
f fill orders. We have little insight into the time to test, testing conditions or ultimate
results. Other customers may require similar conditions of purchase. Testing may have a negative impact on our ability to recognize
product revenue either due to the time it takes to test and approve the release of a shipment or if the customer experiences problems with
testing or if testing results are outside of the customer acceptance criteria.
In Japa
a
n, the Japanese Red Cross controls a significant majo
a rity of blood transfus
f
ions and exerts a high degree of influence on the
adoption and use of blood safety measures in Japa
a
n. The Japanese Red Cross has been reviewing preclinical and clinical data on pathogen
reduction of blood over a number of years and has yet to make a for
f
mal determination to adopt any pathogen reduc
d
tion approach. Befor
f
e
the Japanese Red Cross would consider our products, we understand that we may need to commit to making certain product config
f uration
changes, which are currently under development but may not be economically or technologically feasible for us to accomplish.
Significant increases in demand may occur given the concentrated nature of many of the largest potential customers and the potential
for a mandate by public health agencies to adopt pathogen reduc
d
tion technologies. Should those customers choose to adopt and
standardize their production on the INTERCEPT Blood System or be required to adopt and standardize on the INTERCEPT Blood
System, our ability to meet associated increases in demand will likely be constrained due
d
to a variety of factors, including production
capacity at approved manufact
f
ur
t
ing sites, suppl
u
y issues, manufact
f
ur
t
ing disrupt
u ions, availability of disposable kits manufact
f
ur
t
ed from
obsolete plastic materials, or other obsolescence of parts, among others. If we encounter sustained growth or accelerated growth, our
production capacity may be strained, at least temporarily or should we encounter disrupt
r
ions, supply shortages, or shipping delays, we
may have to allocate availabl
a e products to customers, which could negatively impact our business and reputation or cause those
customers to adopt competing products.
We may b
a
e unable t
l
o d
t
ev
d
elop
l
and maint
i
ai
t n a
i
n effe
e
ctiv
t e and qualif
l ie
f d U.S
U
.-
S based commercial organ
r
izatio
t n or educate blood
l
centers,
clin
l
icians and hospi
s ta
i l perso
r
nnel. A
l
s a result, we may n
a
ot be able t
l
o s
t
uccessfu
s
lly educate t
t
he
t
market on the value of patho
t
ge
o
n
reductio
t n or commercialize our products i
t
n t
i
he
t
U.S.
Successful
f ly commercializing our products in the U.S. has taken more time than anticipated and has required us to continue to invest in
commercialization efforts to build and maintain relationships, additional routine-use data and trus
r
t fro
f
m the industry.
r
We continue to
need to attract, retain, train and suppor
u
t sales, marketing and scientific and hospital affairs personnel and other commercial talent. Our
hospital affairs professionals may be ineffective in educating hospitals and physicians on our products, clinical trial history and
publications. Hospital affairs professionals are highly educated and trained profes
f
sionals and the hiring and employment market for
f
hospital affairs professionals is highly competitive. We may be unabl
a e to develop and maintain adequate and/or effe
f ctive hospital affairs,
sales and marketing capabilities for
f
the U.S. market and we also may not be able to devote suffi
f cient effective resources to the
advertising, promotion and sales efforts for
f
the platelet, plasma or cryopr
r
ecipitation systems in the U.S. In any event, if we are unabl
a e
to develop and maintain an effe
f ctive and qualifie
f d U.S. based commercial organization, we may fai
f l to realize the full sales potential of
our commercial products in the U.S. which would materially and adversely affect our business, financial condition, results of operations
and growth prospects.

26
We have very limited expe
e
rience selling dir
d ectly t
l
o h
t
ospi
s ta
i ls or expe
x
rtis
t e compl
m yi
l ng
i
with
i
regu
e
lations governing
i
fini
i
sh
i
ed biologi
l
cs,s
and our inability
i
to successfu
s
lly c
l
ommercialize the
t
INTE
N
RCE
E
PT
E
Blood
l
System
t
for cryoprecipitation in the U.S
U
. w
S
ould have a
material adverse
r
effe
f ct on our business, fina
i
ncial conditio
i
n, results of operations and growth p
t
rospects.
We have very limited experience selling directly to hospitals nor do we have prior experience or expertise complying with regulations
governing fin
f ished biologics. The introduction of new models of doing business require extensive training of our personnel and may
lengthen the time it takes for
f
our IFC business to be ful
f ly operational. Furthermore, contracting with individual hospitals is time
consuming and is ofte
f n a protracted and bespoke process. Our blood center customers may view the sale of biologics directly to hospitals
as a competitive threat, which may adversely affect our customer relationships, could negatively impact our business prospects and
could result in loss of business and revenue. Conversely, we may also sell the disposable kits directly to blood centers for the manufact
f
ur
t
e
of IFC for
f
their own account or for hospitals with whom they already have contracts in place. As a result, we may be directly competing
with these blood centers for
f
the sale of IFC. These blood centers have more experience and existing contracts with hospitals and may
be able to offe
f r synergies that we cannot, each of which may negatively impact our ability to compete successful
f ly.
In addition, until we are successful in selling INTERCEPT Blood System for Cryoprecipitation kits to blood centers or affi
f liate
organizations or hospitals with in-house blood centers, our ability to directly commercialize fin
f ished IFC throughout the U.S. is
dependent on the app
a
roval of manufac
f
turing site BLAs by the FDA or the addition of an increased number of IFC manufac
f
turing
collabor
a
ations. Furthermore, most of our agreements with blood center manufact
f
ur
t
ing partners do not contain minimum production
requirements. If our blood center manufact
f
ur
t
ing partners do not produce suffi
f cient quantities of IFC, or at all, our commercialization
effo
f
rts will be negatively impacted. Delays may impact our ability to suppl
u
y IFC in sufficient quantities. In addition, in order to market
and sell fin
f ished IFC to hospital customers throughout the U.S., we may need to identify a
f
nd validate additional manufact
f
ur
t
ing partners
or sell INTERCEPT Blood System for Cryoprecipitation kits to blood centers or affi
f liate organizations or hospitals with in-house blood
centers. We cannot guarantee that we will be abl
a e to successful
f ly negotiate additional agreements with manufac
f
turing partners on terms
that are acceptabl
a e to us. IFC is a product derived from our INTERCEPT Blood System for plasma. As such, any suppl
u
y disrupt
u ions or
failures that could impact our plasma system will have a direct negative impact on the production of IFC. Such suppl
u
y disrupt
u ions could
negatively impact our ability to fulfill
f
customer orders, which will have an adverse effect on our business reputation and the successful
f
introduction and adoption of our new products. Further, unless or until we negotiate committed volume purchase agreements with our
customers, we can provide no assurance that sales of IFC product will occur in a consistent or predictabl
a e manner.
If we are unabl
a e to successfully market IFC to hospitals or comply with unique regulations governing fin
f ished biologics, our ability to
monetize and deliver IFC will be negatively impacted which would materially and adversely affect our business, financial condition,
results of operations and growth prospects. In addition, we may never achieve market acceptance and adoption of IFC by U.S. hospitals
to generate product revenue sufficient to cover its costs.
We may b
a
e lia
l ble a
l
nd we may n
a
eed to w
t
ithdraw our products f
t
ro
f
m the
t
market if our products h
t
arm p
r
eopl
o e.
l
We may b
a
e lia
l ble i
l
f a
i
n
accident occurs in our controlle
l d use of hazardou
d
s mater
t
ials. Our insurance coverage may b
a
e ina
i
dequate t
t
o o
t
ffs
o
et losses we may
incur.
We are exposed to potential liability risks inherent in the testing and marketing of medical devices and biologic products. We may be
liabl
a e if any of our products cause inju
n ry, illness or death. Although we complete preclinical and clinical safety testing prior to marketing
our products, there may be harmful
f
effe
f cts caused by our products that we are unabl
a e to identify i
f
n preclinical or clinical testing. In
particular, unfor
f
eseen rare reactions or adverse side effects related to long-term use of our products may not be observed until the
products are in widespread commercial use. Because of the limited dur
d
ation and number of patients receiving blood components treated
with the INTERCEPT Blood System products in clinical trials, it is possible that harmful
f
effe
f cts of our products not observed in
preclinical and clinical testing could be discovered after a marketing appr
a
oval, or CE Certific
f ate of Confor
f
mity has been received or
afte
f r affixing the CE Mark to our products. For example, in cases where we have obtained regulatory a
r
ppr
a
oval or have affix
f ed the CE
Mark to our products, we have demonstrated pathogen reduc
d
tion to specified levels based on well-establ
a ished tests. However, there is
no way to determine, after treatment by our products, whether our products have completely inactivated all of the pathogens that may
be present in blood components. In addition, even if our produc
d
ts inactivate all pathogens in a blood product, it is ofte
f n diffi
f cult to
determine if pathogens are introduced afte
f r treatment with INTERCEPT due to blood center or hospital mishandling, shipping or other
possibilities. For example, we have recently learned of instances where, following treatment with INTERCEPT, mishandling of the
treated blood components has introduced environmental bacterium. We must help our blood center customers to remain vigilant or
increase their vigilance in adopting best practices regarding blood component handling. Failure to adequately address this risk may call
into question the effi
f cacy of using pathogen reduc
d
tion. There is also no way to determine whether any residua
d
l amount of a pathogen
remains in the blood component treated by our products and there is no way to exclude that such residual amount would be enough to
cause disease in the transfus
f
ed patient or was a result of a potential defec
f
t or lack of efficacy of our products. We could be subject to a
claim fro
f
m a patient that tests positive, even though that patient did not contract a disease. We must report safet
f y events to regulatory
r
authorities, regardless of the imputability of our products. In addition, should personnel at clinical study
t
sites or ultimately, potential
customers, be harmed by amustaline, or believe they have been or could be harmed by amustaline, our insurance coverage may be
insufficient to provide coverage for any related potential liabi
a lities. Amustaline is considered a potent chemical and is the active
compound of our red blood cell system.

27
Although we maintain an active safet
f y monitoring platform with trained personnel, we cannot predict when, if ever, a safety event will
occur or be abl
a e to timely or satisfactorily determine whether or not our product was a cause. We maintain product liabi
a lity insurance,
but do not know whether the insurance will provide adequate coverage against potential liabi
a lities. If we cannot successful
f ly defend
ourselves against product liabi
a lity claims, we may incur substantial liabi
a lities or be required to limit commercialization of our produc
d
ts.
Our research and development activities involve the controlled use of hazardous materials, including certain hazardous chemicals,
radioactive materials and infec
f
tious pathogens, such as HIV and hepatitis viruses. Although we believe that our safety procedur
d
es for
handling and disposing of hazardous materials are adequate and comply with regulatory r
r
equirements, we cannot eliminate the risk of
accidental contamination or injury.
r
If an accident occurs, we could be held liabl
a e for
f
any damages that result.
A recall of our products,
t
eith
i
er voluntar
t
ily or at the dir
d ectio
t n of t
o
he
t
FDA,
D
the compe
m
tent authoritie
t s of a
o
n EU Mem
M
ber Sta
S te, o
e
r
anothe
t
r governmental autho
t
rity
i , i
y
nc
i
luding
i
foreign r
g
egulat
l or
t
y a
r
utho
t
rity
i
or the dis
d covery of serious safet
f y i
t
ssu
i
es with
i
our productst
that leads to corrective actions, c
s
ould have a signi
g
fi
i cant adverse
r
impact on us.
Any adverse event involving our products, whether in the U.S. or abr
a
oad, could result in fut
f ur
t
e voluntary c
r
orrective actions, such as
recalls or customer notific
f ations, or agency action, such as inspection, mandatory recall or other enforcement action. Any corrective
action, whether voluntary o
r
r involuntary,
r
as well as defending ourselves in a lawsuit, will require the dedication of our time and capital,
distract management from operating our business and may harm our reputation and financial results.
Under the FDA’s reporting regulations, we are required to report to the FDA any incident in which our products may have caused or
contributed to a death or serious inju
n ry or in which our produc
d
t malfunctioned and, if the malfunction were to recur, would likely cause
or contribute to death or serious inju
n ry. Regulatory a
r
gencies in other countries have similar authority to recall devices because of material
deficiencies or defects in design or manufact
f
ur
t
e that could endanger health. We may initiate a product recall under our own initiative if
any material defic
f iency in our product is found,
f
such as a component failure, malfunctions, manufact
f
ur
t
ing errors, design or labeling
defects or other deficiencies and issues, or withdraw a product to improve device performance or for other reasons. If we do not
adequately address problems associated with our produc
d
ts, we may face additional regulatory e
r
nfor
f
cement action, including FDA
warning letters, product seizure, injunctions, administrative penalties, or civil or criminal fin
f es. Similar actions and obligations may be
imposed by the competent authorities of an EU Member State, or a foreign regulatory a
r
uthority.
We may also be required to bear other costs or take other actions that may have a negative impact on our sales as well as face
f
significant
adverse publicity or regulatory c
r
onsequences, which could harm our business, including our ability to market our products in the fut
f ur
t
e.
Such events could impair our ability to suppl
u
y our products in a cost-effe
f ctive and timely manner in order to meet our customers’
demands.
If our compe
m
titor
t
s d
r
evel
d
op
l
products s
t
uperior to o
t
urs,
r
market their p
i
roducts m
t
ore effe
e
ctiv
t ely,
l
or receive regulat
l or
t
y a
r
ppr
a
oval or
certific
f atio
t n befor
f
e our products,
t
our commercial oppor
o
tuniti
i es could b
l
e reduced or be elimin
l
ated
t
. C
d
om
C
pe
m
titor
t
s h
r
ave and may
a
contin
t
ue to file
i
clai
l ms
i
in order to i
t
mp
i
ede t
d
he
t
marketabi
t
lity
i
of our products,
t
regar
e
dles
l
s of t
o
he
t
merit o
i
f s
o
uch claims.
We expect our products will continue to encounter significant competition. The INTERCEPT Blood System products and IFC compete
with other app
a
roaches to blood safety currently in use and may compete with future products that may be developed by others. Our
success depends in part on our ability to respond quickly to customer and prospective customer needs, successful
f ly receive and maintain
regulatory a
r
ppr
a
ovals, and adapt to medical and technological changes brought about by the development and introduction of new
products. Competitors’ products or technologies may make our products obsolete or non-competitive. In addition, competitors or
potential competitors may have substantially greater financial and other resources than we have. If competitive pathogen reduc
d
tion
products experience significant problems, customers and potential customers may question the safety and efficacy of all pathogen
reduction technologies, including the INTERCEPT Blood System. Such questions and concerns may impair our ability to market and
sell the INTERCEPT Blood System.
Several companies have, or are developing, technologies that are, or in the fut
f ur
t
e may be, the basis for
f
products that will directly compete
with or reduce the market for our pathogen reduc
d
tion systems. A number of companies are specifically focusing on alternative strategies
for pathogen reduc
d
tion in platelets and plasma. These alternative strategies may be more effe
f ctive in reduc
d
ing certain types of pathogens
from blood products, including certain non-lipid-enveloped virus
r
es, such as hepatitis A and E virus
r
es or human parvovirus B-19, which
our products have not demonstrated an abi
a lity to inactivate or have not demonstrated a high level of inactivation. If our customers
determine that competitor’s produc
d
ts inactivate a broader range of pathogens that are of particular interest to the transfusion medicine
community, market adoption of our platelet and plasma products may be adversely impacted. In addition, customers and prospective
customers may believe that our competitors’ products are safer
f , more cost effective or easier to implement and incorpor
r
ate into existing
blood processing procedur
d
es than INTERCEPT Blood System products. Moreover, regulatory a
r
gencies may mandate use of competing
products which would limit our ability to sell our products in those markets.
In addition, while we believe that IFC has many advantages over competitors, traditional cryoprecipitate and fib
f rinogen concentrates
are well established within hospital use. Even if we are able to generate compelling data regarding the use of IFC over other products or
traditional cryoprecipitate, hospitals may not perceive the advantage of IFC over the competing products and we may be ineffe
f ctive in
selling biological agents directly to hospitals or be unabl
a e to demonstrate the economic or patient advantages to customers relative to

28
the competitors. Further, competitors may have more experience marketing and selling products directly to hospitals and may try t
r
o
impede the marketability of our products. If additional BLAs are delayed or are never issued to our manufact
f
ur
t
ing partners, we may not
have enough production capacity to suppl
u
y demand, especially in states outside of the home states of our manufact
f
ur
t
ing partners. A
byproduct of producing IFC is pathogen reduc
d
ed cryopr
r
ecipitate poor plasma. If we are unabl
a e to fin
f d a commercial outlet for
f
pathogen
reduced cryopr
r
ecipitate poor plasma, we will continue to incur costs to discard the byproduct, which will continue to negatively impact
our operating results.
If competitors receive regulatory approval, certific
f ation, or are abl
a e to receive advantageous labe
a
l claims sooner or less costly than we
are abl
a e to, the marketabi
a lity of our products in those geographies will be at a disadvantage. Regulators may not apply the same criteria
for our products or competitive products which may require us to incur additional costs, may delay or preclude approval decisions by
such regulators, or provide competitors with a market advantage over our products, any of which could materially and adversely affect
our business, financial condition, results of operations and growth prospects.
Our platelet and plas
l
ma products a
t
nd product candid
d at
d es
t
are not compatib
t le with
i
some collectio
t n, productio
t n and stor
t
age methods
or combinatio
t ns thereof.
o
Furthe
t
r, blood
l
centers using INT
I
ERC
T
EP
C
T must have access to t
t
ho
t
se certai
t n d
i
ev
d
ices, b
s
lood bags, a
s
ssays
a
or
plat
l el
t et
l
additi
i ve solutions that are compat
m
ib
t le with
i
our products.
t
The equipment and materials used to collect platelets vary b
r
y manufact
f
ur
t
er and by geographic region. Platelets may be collected fro
f
m
a single donor by apheresis using an automated collection machine. Apheresis devices currently used in the U.S. and European markets
differ, among other characteristics, in their ability to collect platelets in reduc
d
ed volumes of plasma. Platelet collection device
manufac
f
turers may need to modify device collection parameters or softw
f
are befor
f
e a prospective customer could use INTERCEPT. If
these manufac
f
turers are not cooperative or are resistant to assist their customers or do not assist with making such modifications, the
potential market for our products may be limited. Platelet concentrates may also be prepared fro
f
m whole blood by pooling together
platelets fro
f
m multiple donors. There are two commonly used methods for preparing whole blood platelets: the buffy
f
coat method,
which is used extensively in Europe, and the pooled random donor method, which is used in the U.S., though it represents the minority
of collections. Outside of the U.S., our platelet systems are used to treat both aphe
a
resis and buffy
f
coat collected platelets. Although there
is currently a shortage of platelets in the U.S., until buffy
f
coat platelets are accepted by the FDA, use of our platelet system in the U.S.
will be limited to aph
a
eresis collected platelets. Our platelet system is designed to work with platelets collected and stored in storage
solutions, called InterSol and SSP+, and for platelets suspended in 100% plasma. Fresenius is the exclusive manufac
f
turer of InterSol
and MacoPharma of SSP+, both widely-used PAS. Many of our customers and prospective customers use InterSol or SSP+ in connection
with INTERCEPT treatment. Similarly, some of our customers combine multiple platelet or plasma components before
f
treating the
combined product with INTERCEPT. Further, blood centers using INTERCEPT must have access to those certain devices, blood bags,
assays or platelet additive solutions that are compatible with our products. In the past, we have learned of concerns about manufact
f
ur
t
ers’
ability to provide an uninterrupt
u ed suppl
u
y of PAS solutions to our blood center customers. Should such a suppl
u
y disrupt
u ion occur, our
customer’s ability to treat platelets using INTERCEPT may be negatively impacted or may require us to secure approval for
f
and supply
PAS, for which we do not currently have regulatory a
r
ppr
a
oval.
We understand that several third-party manufact
f
ur
t
ers of pooling sets are planning to discontinue producing pooling sets due
d
to the
requirement to comply under the new European Union Regulation (EU) 2017/745, the Medical Device Regulation, or MDR. Our
customers’ ability to use our INTERCEPT products may be impaired should manufact
f
ur
t
ers of those products cease production or if our
customers are unabl
a e to fin
f d an alternate pooling set meeting their quality and production requirement for their produc
d
tion of
INTERECEPT-treated blood components. Moreover, in order to alleviate any disrupt
r
ion to our customers, we have chosen to stockpile
pooling sets, which required use of capi
a tal for
f
a marginally profit
f able non-core product. In addition, should other manufac
f
turers of
collection devices, compatible assays and blood bags, pooling sets or platelet additive solutions fail to obtain or maintain regulatory
r
approval or a CE Certific
f ate of Confor
f
mity necessary for affixing the CE Mark to their products under the MDR, experience unexpected
production disrupt
u ion, or decide to cease distribution of those respective products to customers and prospective customers, or
prohibitively increase costs, our ability to sell the INTERCEPT Blood System may be impaired and acceptance within the marketplace
could be harmed.
In order to address the entire market in the U.S., Japan, and potentially elsewhere, we will need to develop and test additional
config
f urations of the platelet system. For example, in the U.S., we understand a significant number of platelet concentrates are derived
from larger volumes collected from aphe
a
resis donors split into three therape
a
utic transfus
f
able doses, known as triple dose collections.
While we have trained many customers to break down such donations to volumes and doses compatible with our produc
d
ts other
prospective customers may not want to modify their operating practices and may therefor
f
e choose alternative compliant practices. In
order to enabl
a e these customers to treat triple dose collections, we would need to develop future config
f urations of the platelet system,
which is not in our current business plan. We estimate that the majority of platelets used in the U.S. are collected by apheresis, though
a significant minority is prepared fro
f
m pooled random donor platelets derived from whole blood collections. Some blood centers may
view pooled random donor platelets treated with INTERCEPT as an economically optimal appr
a
oach. In order to gain regulatory
r
approvals for the use of INTERCEPT in a manner compatible with triple dose collections, and random donor platelets, we would need
to perform additional product development and testing, including the possibility of additional clinical trials. We may also need to
demonstrate the safety and efficacy of our platelet system using a variety of config
f urations before our platelet system would be appr
a
oved

29
for such config
f urations. Unless and until we decide to pursue and potentially obtain appr
a
oval of these additional product config
f urations,
we will not be able to fully address those portions of the market, which will continue to limit our product revenue. In the U.S, our
approved labels for
f
the platelet system fro
f
m the FDA limit our current approvals to certain platelet collection platfor
f
ms and a particular
storage solution for
f
the particular collection platfor
f
m. For instance, our approved claims permit aphe
a
resis collection of platelets on the
Fresenius Amicus device while stored in an additive solution or for
f
apheresis collection of platelets collected on the Terum
r
o Trima
device and stored in 100% plasma. While we are seeking to generate acceptabl
a e data for
f
Amicus collected platelets stored in 100%
plasma, we cannot assure you that the data will be acceptabl
a e to the FDA or that we will receive timely approval, if ever. We may be
required to provide the FDA with data for each permutation for
f
which blood banking treatment practices exist which may be time
consuming, costly and limit the potential size of the U.S. market that can use our products. In addition, given that there is some loss of
platelets using our product, blood centers may need to increase collection volumes in order to use our product. Given the current blood
component shortage, increased collection volumes may not be achievabl
a e or use of INTERCEPT may be considered less effi
f cient than
other operating practices, particularly in regions such as the U.S. where we do not maintain a seven day platelet storage claim. Given
the scarcity of platelets in the U.S., hospitals may choose to take any availabl
a e and useful
f
platelet unit, whether or not it is treated with
INTERCEPT and which blood centers may choose to defer
f
adoption or increased usage of INTERCEPT due to a perceived lack of
demand from their hospital customers. Platelet dose requirements vary g
r
reatly between regulatory a
r
gencies around the world. In areas
where appr
a
oved platelet dosage levels are relatively high, such as the U.S., any loss of platelets by using INTERCEPT may result in a
lower produced yield at blood centers. Given the current shortage of platelets in the U.S., blood centers may not want to adopt or increase
production of INTERCEPT-treated platelets if they fee
f
l it will impact their ability to comply with the relatively high dosage requirements
required by the FDA. Similarly, to achieve market acceptance in certain geographies, we may be required to design, develop and test
new product config
f urations for the plasma systems. In addition, we will need to continue to generate acceptable data in order to confor
f
m
with the evolving collection practices such as automated whole-blood collection. If we are unabl
a e to confor
f
m to evolving collection
practices our ability to address those portions of the market may be compromised. In any event, any fai
f lures or delays in obtaining FDA,
CE Certific
f ates of Confor
f
mity and other regulatory a
r
ppr
a
ovals for any new config
f urations or product improvements would adversely
affe
f ct our ability to introduce new or enhanced products in a timely manner, which in tur
t
n could materially harm our product revenue
and prospects for
f
potential fut
f ur
t
e profitabi
a lity.
Clin
l
ical trials are costly and time
t
consuming, may t
a
ake
t
longer than we expe
x
ct or may n
a
ot be completed at all, and the
t
ir outcomes are
uncertain. A failure to generate data i
t
n c
i
lini
i
cal tri
t als t
l
o s
t
uppor
p
t expan
e
ded labe
l
l claims or to suppor
u
t marke
r
ting appr
a
ovals o
l
r
certific
f atio
t n for
f
our product candidates
t
could m
l
ater
t
ially and adverse
r
ly affe
f ct our business, fina
i
ncial conditi
i on, results
l
of operations
and growth p
t
rospects.
We are currently conducting clinical trials for our products and product candidates and plan to commence additional clinical trials of
our products and product candidates in the future. We cannot be certain that the design or conduct of, or data collected from, these trials
will be sufficient to support FDA approval, a CE Certificate of Confor
f
mity prior to affixing a CE Mark or any other regulatory a
r
ppr
a
ovals
outside the U.S. If we fai
f l to produce positive results in our ongoing or planned clinical trials, the development timeline and regulatory
r
approval and commercialization prospects for our produc
d
ts and our product candidates, and, correspondingly, our business, financial
condition, results of operations and growth prospects, would be materially adversely affected. We do not know whether we will begin
or complete clinical trials on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays in obtaining
regulatory a
r
pp
a
roval to commence a study,
t
delays in reaching agreement on acceptabl
a e clinical study
t
agreement terms with prospective
clinical sites, interrupt
u ions or delays in blood center production of the blood components used for
f
the clinical trial, delays in recrui
r ting
subj
u ects to participate in a study,
t
delays in obtaining institutional review board, ministry o
r
f health or ethics committee appr
a
oval to
conduct a study
t
at a prospective clinical site, delays in the conduct of the clinical trial by personnel at the clinical site or due to our
inability to actively and timely monitor clinical trial sites because of travel restrictions, extreme weather or other natural for
f
ces, terrorist
activity or general concerns over employee safet
f y. For example, we experienced delays in our RedeS and ReCePI studi
t
es related to the
COVID-19 pandemic. In addition, some clinical sites for
f
the RedeS study
t
are located in areas that are subject to disrupt
r
ion by severe
weather such as flo
f oding, hurricanes or other natural for
f
ces such as earthquakes, which have delayed enrollment and progress of the
RedeS study in the past. Moreover, clinical trial enrollment at additional RedeS clinical trial sites have commenced later than previously
anticipated, and we are continuing to assess the potential impact of that delay on the anticipated timing for
f
completion of the RedeS
study
t
which, if that anticipated timing is delayed, would delay the timing of our planned fin
f al PMA module submission. If we are unabl
a e
to enroll a suffi
f cient number of patients for
f
the RedeS study
t
to generate the data needed for
f
licensure, we will need to reach agreement
with the FDA on sufficiency of fewer patients, or a new pathway to generate suffi
f cient data for
f
the red blood cell system, including the
potential for additional Phase 3 clinical trials beyond what we are currently contemplating. If we see any treatment emergent antibodies
with amustaline specificity without evidence of hemolysis in patients receiving INTERCEPT-treated RBCs in any of our Phase 3 trials,
the FDA will require us to place a clinical hold and we will need to investigate the underlying cause, which would cause delay. In any
event, we cannot be certain that fur
f
ther delays in the RedeS stud
t
y or other clinical trials will not occur.
Criteria for
f
regulatory a
r
pp
a
roval in blood safety indications are evolving, reflecting competitive advances in the standard of care against
which new product candidates are judged, as well as changing market needs and reimbursement levels. Clinical trial design, including
enrollment criteria, endpoints and anticipated labe
a
l claims are thus subj
u ect to change, even if original objectives are being met. As a
result, we do not know whether any clinical trial will result in marketabl
a e products. Typically, there is a high rate of fai
f lure for product

30
candidates in preclinical studi
t
es and clinical trials and products emerging from any successful
f
trial may not reach the market for
f
several
years.
Enrollment criteria for
f
certain of our clinical trials may be quite narrow, further delaying the clinical trial process. For instance, clinical
trials previously conducted using INTERCEPT-treated plasma for patients with thrombotic thrombocytopenic purpur
r
a lasted
approximately four years due
d
in part to the diffi
f culties associated with enrolling qualifie
f d patients. In addition, enrollment criteria
impacted the speed with which we were abl
a e to enroll patients in our European Phase 3 red blood cell system trial in chronic anemia
patients, and may impact other studi
t
es. Given the need to phenotypically match donations and patients and the existing burden of
managing the production and supply to sickle-cell anemia patients, donor recrui
r tment in chronic anemia patients may be diffic
f ult or
impractical, which may be costly or significantly delay or preclude our ability to obtain any FDA appr
a
oval of our red blood cell system.
We cannot rely on interim results of trials to predict their final results, and acceptabl
a e results in early trials might not be repeated in later
and larger clinical trials or in the results of routine use. Any trial may fail to produce results satisfact
f
ory t
r
o the FDA, foreign regulatory
r
authorities, or Notified Bodies. In addition, preclinical and clinical data can be interpreted in diffe
f rent ways, which could delay, limit or
prevent regulatory a
r
pp
a
roval. Negative or inconclusive results from a preclinical study
t
or clinical trial, or adverse medical events during
a clinical trial could cause a preclinical study
t
or clinical trial to be repeated, require other studies to be performed or cause a program to
be terminated, even if other studi
t
es or trials relating to a program are successful
f .
We have conducted many toxicology studi
t
es to demonstrate the safety of the platelet and plasma systems, and we have conducted and
plan to conduct toxicology studi
t
es for the red blood cell system throughout the product development process. At any time, the FDA and
other regulatory a
r
uthorities or Notifie
f d Bodies may require further toxicology or other studies to further demonstrate our produc
d
ts’
safety, which could delay or preclude regulatory a
r
pp
a
roval and commercialization. Furthermore, any major changes to components used
in our products or config
f uration changes to our products may require additional toxicology studi
t
es which may not produce acceptabl
a e
results. Beyond toxicology studi
t
es, changes to our products or the manufact
f
ur
t
ing process of our products may require additional aging
and stabi
a lity data in order to satisfy regulators and maintain historical labe
a
l claims. For instance, despite having 24 month aging for our
products in many territories around the world, the FDA has limited the shelf life o
f
f our platelet product to 18 months for any platelet kit
produced using a new solvent for the manufac
f
ture of a component. In addition, the FDA or foreign regulatory a
r
uthorities may alter
guidance at any time as to what constitutes acceptabl
a e clinical trial endpoints or trial design, which may necessitate a redesign of our
product or proposed clinical trials and cause us to incur substantial additional expense or time in attempting to gain regulatory a
r
ppr
a
oval.
Regulatory a
r
gencies weigh the potential risks of using our pathogen reduc
d
tion products against the incremental benefits
f
, which may be
difficult or impossible to quantify.
f
If any additional product candidates receive approval for
f
commercial sale in the U.S., or if we obtain appr
a
oval for
f
expanded label claims
for the platelet system or plasma system, the FDA may require additional post-approval clinical or in vitro studi
t
es as a condition of
approval. While we have completed the two post-approval studies required by the FDA, there is no guarantee that we will be able to
complete future studi
t
es required as a condition of approval. The post-approval studies we have been required to complete and any
additional studies that the FDA may require could involve significant expense, may require us to secure adequate funding to complete
and may not be successful
f . In addition, enrollment of post-marketing studies may be diffi
f cult to complete timely if customers of blood
centers are reluctant to accept conventional, non-INTERCEPT-treated products once INTERCEPT products become availabl
a e to them.
Other regulatory a
r
uthorities or Notifie
f d Bodies outside of the U.S. may also require post-marketing studies. Failure to successful
f ly
complete post-marketing studies may place certain restrictions on the use of our products or regulators could suspend or revoke our
approvals.
The red blood
l
cell system
t
is currently
t
in developm
l
ent and may n
a
ever receive any m
n
arke
r
ting appr
a
ovals o
l
r CE C
C
er
C
tifi
i cates of
o
Confor
f
mity
r
.y
The red blood cell system has not been approved for
f
marketing or commercialization anywhere in the world. Significant development
and fin
f ancial resources will be required to progress the red blood cell system into a commercially viable product and to obtain the
necessary CE Certific
f ate of Confor
f
mity and other regulatory approvals for the product or any future iterations or changes to the produc
d
t.
In this regard, in October 2024, we announced that the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for the
red blood cell system, reviewed the medicinal product or active pharmaceutical ingredient data of our MDR appl
a
ication for
f
confor
f
mity
assessment and a CE Certificate of Confor
f
mity to affi
f x a CE Mark to our red blood cell system and concluded that the data included in
the module were insufficient to support the proposed classification of the impurity profil
f e of the final product, necessitating the closure
of our MDR appl
a
ication without an approval. In collabor
a
ation with TÜV-SÜD, our Notified Body for the red blood cell system, we are
assessing strategies for a potential new MDR application, including data needed to address the classification questions raised by CBG
and the associated timeline. We cannot predict with certainty when, if ever, we will be able to satisfactorily address CBG’s conclusions
and as such, cannot predict if or when we will subm
u
it a new MDR appl
a
ication for
f
the red blood cell system and, if subm
u
itted, when a
decision concerning certification would occur. In any event, given the closure of our MDR appl
a
ication without an approval, we do not
expect to receive CE Mark approval of the red blood cell system for
f
at least eighteen months from a potential subm
u
ission, if ever.
Moreover, regulators or Notifie
f d Bodies may require clinical data for our red blood cell system under each collection and processing
method using various additive or storage solutions before they would grant approval for
f
any such config
f uration. The clinical data we
have generated thus far for
f
the red blood cell system does not suppor
u
t multiple config
f urations of collection processes, storage solutions

31
and kits. If we are required to and are ultimately unabl
a e to collect data under each config
f uration or if we limit our pursuit of certain
config
f urations over others, our market opportunity may be limited. In any event, any failure or further delays in completing the
development activities for the red blood cell system would prevent or continue to delay its commercialization, which would materially
and adversely affect
f
our business, financial condition, results of operations, growth prospects and potential future market adoption of
any of our products, including the red blood cell system.
In some instances, we are relying on contract research organizations and other third parties to assist us in designing, managing,
monitoring and otherwise carrying out our clinical trials and development activities for
f
the red blood cell system. We do not control
these third parties and, as a result, they may not treat our activities as their highest priority, or in the manner in which we would prefer,
which could result in delays, ineffi
f cient use of our resources and could distract personnel fro
f
m other activities. Additionally, if we, our
contract research organizations, other third parties assisting us or our study
t
sites fai
f l to comply with applicable good clinical practices,
the clinical data generated in our trials may be deemed unreliabl
a e and the FDA or foreign regulatory a
r
gencies or Notifie
f d Bodies may
require us to perform additional clinical trials befor
f
e delivering a CE Certific
f ate of Confor
f
mity or approving the red blood cell system
for commercialization. We cannot assure you that, upon
u
inspection, regulatory a
r
gencies will determine that any of our clinical trials
comply with good clinical practices. We must also demonstrate to the FDA an abi
a lity to define, test, and meet acceptable specifications
for our current manufact
f
ur
t
ed compounds used to prepare INTERCEPT-treated red blood cells before we can initiate our planned modular
PMA appl
a
ication submission to and seek regulatory approval of the red blood cell system from the FDA. This may require that we can
demonstrate stabi
a lity of our active compounds manufact
f
ur
t
ed under the FDA’s cGMP regulations and similar requirements outside of
the U.S. to meet release specifications. Our contracted manufac
f
turer has had a history o
r
f fai
f lure in manufac
f
turing the active compound
of the red blood cell system. If we are unabl
a e to demonstrate an abi
a lity to manufact
f
ur
t
e according to our specifications under cGMP or
similar requirements outside of the U.S. with acceptable stability data, we may be unabl
a e to satisfy regulatory q
r
uestions and requirements
which could prevent or delay the potential appr
a
oval of or our ability to commercialize the red blood cell system. In addition, existing
lots of these red blood cell compounds manufac
f
tured under cGMP may be dispositioned by regulators or ourselves as unsuitabl
a e for
f
clinical use which would impact our ability to produce INTERCEPT-treated red blood cells for ongoing and fut
f ur
t
e clinical trials and
may require changes to the manufac
f
turing process of our red blood cell compounds or new production of the compounds, all of which
would be costly and time consuming and impact our ability to perform under our BARDA agreements.
In addition to the two chemical components of the INTERCEPT RBC System, amustaline and glutathione, there are additional
subs
u
tances contained with the Processing Set (Processing Solution and SAG-M Storage Solution) that contain substances which are
considered as ancillary medicinal substances by either the Notifie
f d Body in the EU. If we are unabl
a e to provide data on the use of these
ancillary m
r
edicinal subs
u
tance with INTERCEPT red blood cells, our ability to satisfy t
f
he requirements for
f
CE Certific
f ate of Confor
f
mity
under a potential new MDR app
a
lication will be impaired.
In 2003, we terminated Phase 3 clinical trials evaluating a prior generation of the red blood cell system in acute and chronic anemia
patients. The trials were terminated due
d
to the detection of antibody reactivity to INTERCEPT-treated red blood cells in two patients in
the 2003 chronic anemia trial. Although the antibody reactivity was not associated with any adverse events, we developed process
changes designed to diminish the likelihood of antibody reactivity in red blood cells treated with our modified process. While we
successful
f ly completed the European Phase 3 acute anemia clinical trial and the European Phase 3 chronic anemia clinical trial, we
cannot assure you that the adverse events observed in the terminated 2003 Phase 3 clinical trials of our earlier red blood cell system will
not be observed in current and potential fut
f ur
t
e clinical trials using our modified process. We also cannot assure you that patients
receiving INTERCEPT-treated red blood cells will not develop allergic reactions to the transfusion.
We will need to successful
f ly conduct and complete the ongoing RedeS study in the U.S. and continue to believe that we will also need
to conduct and complete, and generate acceptabl
a e data fro
f
m, an additional Phase 3 clinical trial including chronic anemia patients in the
U.S., in vitro studi
t
es, and other necessary activities befor
f
e the FDA will consider our red blood cell system for
f
potential approval. Given
the need to phenotypically match donations and patients and the existing burden of managing the production and suppl
u
y to sickle-cell
anemia patients, donor recrui
r tment in chronic anemia patients may be difficult or impractical, which could significantly delay or preclude
our ability to subm
u
it and complete our planned modular PMA appl
a
ication submission on the anticipated timeline or at all and to otherwise
obtain any FDA appr
a
oval of our red blood cell system. In any event, there can be no assurance that we will be able to successful
f ly
complete the RedeS study
t
or generate acceptabl
a e Phase 3 clinical data from chronic anemia patients in the U.S. We anticipate the fin
f al
PMA module submission upon the completion of the RedeS study, assuming that we have generated acceptabl
a e Phase 3 chronic anemia
data. While we previously anticipated that the completion of the RedeS study and the planned fin
f al PMA module submission would
occur in the second half of 2026, clinical trial enrollment at additional RedeS clinical trial sites commenced later than previously
anticipated and we are continuing to assess the potential impact of that delay on the anticipated timing for
f
completion of the RedeS
clinical trial and the planned fin
f al PMA module submission. Any delay on the planned fin
f al PMA module submission would potentially
increase our development costs and delay the potential commercialization of the red blood cell system in the U.S. In any event, for our
planned modular PMA application, we will seek to introduce supplemental clinical data we obtained fro
f
m European clinical trials,
though we cannot assure you that we will be able to demonstrate comparabi
a lity or that the FDA will allow supplemental clinical
European data. In addition, if we are unabl
a e to enroll a sufficient number of patients for
f
the RedeS study
t
to generate the data needed for
f
licensure, we will need to reach agreement with the FDA on a new pathway to generate sufficient data for
f
the red blood cell system,
including the potential for
f
additional Phase 3 clinical trials beyond what we are currently contemplating. Moreover, if treatment emergent

32
antibody reactions associated with hemolysis are observed in any of our Phase 3 trials, the FDA will require us to place a clinical hold
and we will need to investigate the underlying cause. Such investigations may be diffi
f cult for us to assess imputability which may lead
to a complete halt of the clinical trial, may irreparabl
a y harm our red blood cell product’s reputation and may for
f
ce us to suspend or
terminate development activities related to the red blood cell system in the U.S., which would have a material adverse effect on our
business and business prospects. To date, several S-303 antibody events without evidence of hemolysis have been detected in the RedeS
and ReCePI studies. Though we have not seen any clinical significance to date, we have seen antibody formation to S-303 treated red
blood cells, and we will need to continue to generate data related to S-303 treatment emergent antibodies. In addition, even though we
reported positive topline results from the ReCePI stud
t
y in the first quarter of 2024, this does not ensure that any other clinical trials of
the red blood cell system will be successful
f , including the RedeS study,
t
nor does it ensure that the data from the ReCePI study
t
will be
deemed suppor
u
tive of regulatory a
r
ppr
a
oval by the FDA. In this regard, because non-clinical and clinical data are often susceptible to
varying interpr
r
etations and analyses, regulatory a
r
uthorities, including the FDA, may disagree with our interpretation of the data from
any of our completed clinical or non-clinical trials and may require additional clinical testing and/or further analyses from
f
completed
clinical or non-clinical trials before we can obtain regulatory a
r
ppr
a
oval and begin commercialization of the red blood cell system, if at
all, any of which could result in increased costs to us, limit our ability to generate revenue and adversely affect our commercial prospects.
We completed our European Phase 3 clinical trials of our red blood cell system for acute anemia patients and separately for chronic
anemia patients. We filed our application for
f
confor
f
mity assessment and a CE Certific
f ate of Confor
f
mity related to the red blood cell
system in December 2018 under the Medical Device Directive, or MDD, and in June 2021, we completed the resubm
u
ission of our
application under the new MDR. In October 2024, we announced that CBG, the Competent Authority for
f
the red blood cell
system, reviewed the medicinal product or active pharmaceutical ingredient data of our MDR appl
a
ication and concluded that the data
included in the module were insuffi
f cient to support the proposed classification of the impurity profile
f
of the fin
f al product, necessitating
the closure of our MDR appl
a
ication without an approval. In collabor
a
ation with TÜV-SÜD, our notifie
f d body for the red blood cell
system, we are assessing strategies for a potential new MDR appl
a
ication and the associated timeline. We cannot predict with certainty
when, if ever, we will be able to satisfactorily address CBG’s conclusions and as such, cannot predict if or when we will subm
u
it a new
MDR appl
a
ication for
f
the red blood cell system and, if subm
u
itted, when decision concerning certific
f ation would occur. In any event,
given the closure of our MDR appl
a
ication without an approval, we do not expect to receive CE Mark appr
a
oval of the red blood cell
system for at least eighteen months from a potential submission, if ever. However, we do not yet know whether the data generated fro
f
m
our European Phase 3 clinical trials will be sufficient to support a potential new MDR appl
a
ication or a CE Certific
f ate of Confor
f
mity,
even if limited to a target patient population having chronic anemia. We do not know if data from the ReCePI Phase 3 clinical trial will
be accepted by TÜV or whether such data would be supportive of expanding the target patient population beyond chronic anemia patients
or whether such data will be accepted at all. In addition, the European Phase 3 clinical trials in acute, and separately, chronic anemia
patients, may need to be supplemented by additional, successful
f
Phase 3 clinical trials for appr
a
oval in certain countries. If such additional
Phase 3 clinical trials are required, they would likely need to demonstrate non-inferiority of INTERCEPT red blood cells compared to
conventional red blood cells and the significantly lower lifes
f
pan for
f
INTERCEPT red blood cells compared to conventional red blood
cells may limit our ability to obtain any regulatory a
r
pp
a
rovals or certification in certain countries for the red blood cell system. A number
of trial design issues that could impact effi
f cacy, regulatory a
r
ppr
a
oval, certification and market acceptance will need to be resolved prior
to the initiation of further clinical trials.
If we are unsuccessful
f
in advancing the red blood cell system through clinical trials, resolving process and product design issues,
providing satisfactory d
r
ata surrounding additional medicinal subs
u
tances and classification of the medicinal produc
d
t or active
pharmaceutical ingredient, securing commercial manufact
f
ur
t
ing for
f
sufficient volumes or if our manufact
f
ur
t
ers continue to fail to be able
to produce suffi
f cient volumes of the active ingredients or if we are unsuccessful
f
in obtaining subs
u
equent regulatory a
r
ppr
a
ovals or
certification and acceptable reimbursement rates, we may never realize a retur
t
n on our R&D expenses incurred to date for
f
the red blood
cell system program. Regulatory d
r
elays, including those resulting fro
f
m the failure to obtain appr
a
oval of our MDR app
a
lication for
f
the
red blood cell system, can also materially impact our product development costs. When we experience delays in testing, conducting
trials or approvals or certification, our product development costs will increase, which may exceed the budgets or timeframe under our
BARDA agreements or which costs may otherwise not be reimbursabl
a e to us under the BARDA agreements. Even if we were to
successful
f ly complete and receive approval or certific
f ation for
f
our red blood cell system, potential blood center customers may object
to working with a potent chemical, like amustaline, the active compound in the red blood cell system, or may require modifications to
automate the process, which would result in additional development costs, any of which could limit any market acceptance of the red
blood cell system. If the red blood cell system were to face such objections from potential customers, we may choose to pay for capital
assets, specialized equipment or personnel for
f
the blood center, which would have a negative impact on any potential contribution
margin from red blood cell system sales. Moreover, customers may not accept the manual config
f uration of the product and require us
to develop a more operationally scalable version of the system which may not be successful. Currently, our contract with BARDA
contemplates development of a more operationally scalable version. If we are unabl
a e to access funds contemplated under our BARDA
contract for this purpos
r
e, for any reason, the development of a more operationally scalable version may require capital investment which
may be beyond our means. Additionally, the use of the red blood cell system may result in some processing loss of red blood cells. If
the loss of red blood cells leads to increased costs, or the perception of increased costs for
f
potential customers, or potential customers
believe that the loss of red blood cells reduces the efficacy of the transfus
f
ion unit, or our process requires changes in blood center or
clinical regimens, potential customers may not adopt our red blood cell system, even if appr
a
oved for
f
commercial sale.

33
Risks Related to Regulatory Approval, CE Certific
f ates of Confor
f
mity, and Oversight, and Other Legal Compliance Matters
Our compan
m
y,
n
our products,
t
and blood products t
t
re
t
ated
t
with
i
the INT
I
ERCEP
T
T Blood System
t
are subje
b ct to extensive regulat
l io
t n by
b
domestic authoritie
t s, foreign a
g
utho
t
ritie
i
s and Notifie
f d Bodies.
Our products, both those sold commercially and those under development are subj
u ect to extensive and rigorous regulation by local, state
and fed
f
eral regulatory a
r
uthorities in the U.S. and by for
f
eign regulatory b
r
odies and Notifie
f d Bodies. Our products must satisfy rigorous
standards of safet
f y and effi
f cacy and we must adhere to quality standards regarding manufact
f
ur
t
ing and customer-facing business
processes in order for the FDA and international regulatory a
r
uthorities and Notifie
f d Bodies to approve them for commercial use or issue
related CE Certific
f ates of Confor
f
mities. For our product candidates, we must provide the FDA and international regulatory a
r
uthorities
and Notifie
f d Bodies with preclinical, clinical and manufact
f
ur
t
ing data demonstrating that our products are safe,
f
effe
f ctive and in
compliance with government regulations before the products can be appr
a
oved for
f
commercial sale. The process of obtaining required
regulatory a
r
ppr
a
ovals and certific
f ations is expensive, uncertain and typically takes a number of years. We may continue to encounter
significant delays or excessive costs in our effo
f
rts to secure necessary approvals, certific
f ations or licenses, or we may not be successful
f
at all. In addition, our labe
a
ling claims may not be consistent across markets. We have developed our products with the aim to standardize
the volume of platelets treatable by our system, wherever possible, which may not be accepted by all regulators or customers, may
require additional data to support app
a
roval or certific
f ations or may not produce optimal transfusabl
a e blood components. For example,
jurisdictions differ in the definition of what constitutes a transfus
f
able unit of platelets and in certain jurisdictions, our approved label
claims and the definition of a viable platelet unit for
f
transfus
f
ion may allow for
f
a significantly lower or higher platelet count per volume
than certain jurisdictions may allow. This variabi
a lity in platelet count per volume may result in differences in platelet quality once
processed and stored using INTERCEPT, and if customers experience sub-
u
optimal platelet quality following INTERCEPT treatment,
they may limit their adoption of INTERCEPT or consider adoption of competing blood safety technologies over INTERCEPT.
Governments or regulatory a
r
uthorities may impose new regulations or other changes or we may discover that we are subj
u ect to additional
regulations that could fur
f
ther delay or preclude regulatory a
r
ppr
a
oval or certifications and subsequent adoption of our potential produc
d
ts.
We cannot predict the adoption, implementation or impact of adverse governmental regulation that might arise fro
f
m fut
f ur
t
e legislative
or administrative action.
Outside of the U.S., regulations vary by country, including the requirements for
f
regulatory a
r
nd marketing appr
a
ovals, certifications or
clearance, the time required for
f
regulatory r
r
eview and the sanctions imposed for violations. In addition to technical documentation
suppor
u
ting the certific
f ation and CE Marking of our product, countries outside the EU may require clinical data subm
u
issions, registration
packages, import licenses or other documentation. Regulatory a
r
uthorities in Japan, China, Taiwan, South Korea, Vietnam, Thailand,
Singapor
a
e and elsewhere may require in-country clinical trial data, among other requirements, or that our products be widely adopted
commercially in Europe and the U.S., or may delay such appr
a
oval decisions until our products are more widely adopted. In addition to
the regulatory r
r
equirements appl
a
icable to us and to our produc
d
ts, there are regulatory r
r
equirements in several countries around the world,
including the U.S., Germany, Canada, Austria, Australia and other countries, appl
a
icable to prospective customers of INTERCEPT Blood
System products and the blood centers that process and distribute blood and blood products. In those countries, blood centers and other
customers are required to obtain app
a
roved license suppl
u
ements from the appr
a
opriate regulatory a
r
uthorities before making availabl
a e blood
products processed with our pathogen reduc
d
tion systems to hospitals and transfusing physicians. Our customers may lack the resources
or capa
a
bi
a lity to obtain such regulatory a
r
ppr
a
ovals. Significant product changes or changes in the way customers use our produc
d
ts may
require amendments or suppl
u
emental app
a
rovals to licenses already obtained. Blood centers that do subm
u
it applications, supplements or
amendments for manufact
f
ur
t
ing and sale may fac
f
e disapproval or delays in appr
a
oval that could fur
f
ther delay or deter them from using
our products. The regulatory impact on potential customers could slow or limit the potential sales of our products.
We have obtained app
a
roval under the CE Certific
f ate of Confor
f
mity based on the MDR for
f
the INTERCEPT Blood System for platelets
and plasma. We or our customers have received approval for
f
the sale and/or use of INTERCEPT-treated platelets and plasma within
Europe in France, Switzerland, Germany and Austria. Switzerland has accepted to unilaterally recognize CE Marked medical devices.
In addition, we or our customers may also be required to conduct additional testing in order to obtain regulatory a
r
ppr
a
oval in countries
that do not recognize the CE Mark as being adequate for commercializing the INTERCEPT Blood System in those countries. The level
of additional product testing varies by country, but could be expensive or take a long time to complete. In addition, regulatory a
r
gencies
are abl
a e to withdraw or suspend previously issued approvals due to changes in regulatory l
r
aw, our inability to maintain compliance with
regulations or other fact
f
ors. In some countries, including several in Europe, we or our customers may be required to perform additional
clinical studi
t
es or subm
u
it manufact
f
ur
t
ing and marketing appl
a
ications in order to obtain regulatory a
r
ppr
a
oval. If we or our customers are
unabl
a e to obtain or maintain regulatory a
r
pp
a
rovals for the use and sale or continued sale and use of INTERCEPT-treated platelets or
plasma, market adoption of our products will be negatively affe
f cted and our business, financial condition, results of operations and
growth prospects would be materially and adversely impacted.
The advertising and promotion of medical devices in the EU is subj
u ect to the national laws of EU Member States appl
a
ying the MDR,
Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfai
f r commercial practices,
as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices. EU
Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public.

34
In addition, voluntary E
r
U and national industry C
r
odes of Conduct provide guidelines on the advertising and promotion of our products
to the general public and may impose limitations on our promotional activities with healthcare profes
f
sionals.
Moreover, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effe
f ctiveness of our
products in Europe. We must comply with medical device reporting requirements, including the reporting of serious incidents including
malfunc
f
tions related to our products and field safet
f y corrective actions, as well as adverse events occurring during clinical investigations.
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of
unanticipated severity or frequency, manufact
f
ur
t
ing problems, or failure to comply with regulatory r
r
equirements may result in changes
to labe
a
ling, restrictions on such products or manufact
f
ur
t
ing processes, withdrawal of the products from the market, voluntary o
r
r
mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufact
f
ur
t
e or distribute, fines,
suspension, variation or withdrawal of regulatory c
r
learances, CE Certific
f ates of Confor
f
mity or approvals, product seizures, inju
n nctions
or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
The FDA and other regulatory a
r
gencies have in the past, and may in the future, require post-approval studies to be successful
f ly completed
to maintain licensure. Successful
f
enrollment and completion of any other post-approval studies will require that we identify a
f
nd contract
with study
t
sites or hospitals that have the desire and ability to participate and contribute to the study
t
in a timely manner, which we may
be unabl
a e to do in a timely manner or at all. In addition, the FDA may also require us to commit to perform other lengthy post-marketing
studi
t
es, for
f
which we would have to expend significant additional resources, which could have an adverse effect on our financial
condition and results of operations. In addition, there is a risk that post-approval studies will be unsuccessful or show results inconsistent
with our previous studi
t
es. Should this happen, potential customers may delay or choose not to adopt the INTERCEPT Blood System
and existing customers may cease use of the INTERCEPT Blood System. Failure to successful
f ly complete post-marketing studies may
place certain restrictions on the use of our products or regulators could suspend or revoke our approvals.
We understand that we will be required to obtain new PMAs for our INTERCEPT Blood System for Platelets and for
f
Plasma with our
new LED-based illuminator. We are currently working with the FDA to understand the data requirements for
f
those PMAs. If we are
unabl
a e to generate the required data for
f
new PMAs, use of INTERCEPT in the United States will be limited to continued use with the
existing illuminator, which we have a limited number of devices availabl
a e and for which we have a limited time that we can continue to
suppor
u
t and maintain.
We are also required to comply with applicable FDA and other regulatory p
r
ost-approval requirements relating to, among other things,
labe
a
ling, packaging, storage, advertising, promotion, record-keeping and reporting of safet
f y and other infor
f
mation. In addition, our
manufac
f
turers and their facilities are required to comply with extensive FDA and for
f
eign regulatory a
r
uthorities’ requirements, including,
in the U.S., ensuring that quality control and manufac
f
turing procedur
d
es confor
f
m to cGMP and current QSR requirements. We must also
comply with requirements concerning advertising and promotion for
f
our products. For example, our promotional materials and training
methods must comply with FDA and other appl
a
icable laws and regulations, including the prohibition of the promotion of unappr
a
oved,
or off-l
f
abel, use. If the FDA determines that our promotional materials or training constitutes promotion of an off-label use, it could
request that we modify our training or promotional materials or subj
u ect us to regulatory o
r
r enfor
f
cement actions. It is also possible that
other fed
f
eral, state or foreign enfor
f
cement authorities might take action if they consider our promotional or training materials to
constitute promotion of an off-label use, or a violation or any other federal or state law that appl
a
ies to us, such as laws prohibiting false
claims for reimbursement. In addition, our reputation could be damaged and adoption of the products could be impaired.
If a regulatory a
r
uthority or Notifie
f d Body suspects or discovers problems with a product, such as serious incidents, adverse events of
unanticipated severity or frequency, or problems with the facility or the manufact
f
ur
t
ing process at the fac
f
ility where the produc
d
t is
manufac
f
tured, or problems with the quality of product manufac
f
tured, or disagrees with the promotion, marketing, or labe
a
ling of a
product, a regulatory a
r
uthority may impose restrictions on use of that product, including requiring withdrawal of the product fro
f
m the
market. For example the FDA has requested information on bacterial contamination of INTERCEPT-treated products in conjunction
with their investigation of complaints stemming fro
f
m contamination of manufac
f
turing sites and blood centers. Our failure to comply
with applicable regulatory requirements could result in enfor
f
cement action by regulatory a
r
gencies, which may include any of the
following sanctions:
•
adverse publicity, warning letters, fin
f es, injunctions, seizure, consent decrees and civil penalties;
•
repair, replacement, recall or seizure of our products;
•
operating restrictions or partial suspension or total shutdown of production;
•
delaying or refus
f
ing our requests for appr
a
oval of new produc
d
ts, new intended uses or modifications to our existing products
and regulatory s
r
trategies;
•
exclusion fro
f
m participation in government programs, such as Medicare and Medicaid;
•
refusal to grant export or import appr
a
oval for
f
our products or refusal to allow us to enter into government contracts;

35
•
additional reporting obligations and oversight if we become subj
u ect to a corporate integrity agreement or other agreement
to resolve allegations of non-compliance;
•
withdrawing, suspension or variation in marketing appr
a
ovals or CE Certific
f ates of Confor
f
mity that have already been
granted, resulting in prohibitions on sales of our products; and
•
criminal prosecution.
Any of these actions, in combination or alone, could prevent us fro
f
m selling our products and harm our business. In addition, any
government investigation of alleged violations of law could require us to expend significant time and resources in response and could
generate negative publicity.
Should we obtain app
a
roval or a CE Certific
f ate of Confor
f
mity for our red blood cell system, we will likely be required by regulators or
Notifie
f d Bodies to collect additional data in patients receiving INTERCEPT-treated red blood cells. In addition, assuming approval or
certification, we will be required to develop a registry of patients receiving INTERCEPT-treated red blood cells for fut
f ur
t
e data collection
and evaluation. To commence, enroll and complete such a registry, we may incur significant costs. Further, introducing and
implementing use of such a registry m
r
ay face data collection challenges or resistance fro
f
m transfusing physicians, hospitals or patients.
We cannot ensure that the data collected in such a registry w
r
ould support continued use of INTERCEPT-treated red blood cells.
In addition, the regulations to which we are subj
u ect are complex and have become more stringent over time. Regulatory c
r
hanges could
result in restrictions on our ability to carry on or expand our operations, increased operation costs or lower than anticipated sales. For
example, complying with the new MDR will require considerable time, attention and effo
f
rt by our manufac
f
turers and us and may limit
or delay any contemplated changes to our products or expansion of label claims. In addition, regulators have been impacted by the global
staffi
f ng shortage, as well as the volume of existing and new MDR filings, all of which fur
f
ther constrain their ability to review
subm
u
issions timely.
If we or our thi
t
rd
i
-p
d
arty supp
u
liers fail to comply with
i
the FDA
F
’s or othe
t
r regulat
l or
t
y a
r
utho
t
riti
i es’ or for
f
eign
i
regu
e
latory authorities’
good manufac
f
turing
i
practice regulat
l io
t ns, i
s t c
i
ould impair o
i
ur abili
i ty
i
to market our products i
t
n a
i
cost-e
t ffe
e
ctiv
t e and time
i
ly manner.r
In order to be used in clinical studi
t
es or sold in the U.S., our produc
d
ts are required to be manufact
f
ur
t
ed in FDA-approved faci
f
lities. If
any of our suppl
u
iers fail to comply with FDA’s cGMP regulations or otherwise fai
f l to maintain FDA approval, we may be required to
identify an alternate supplier for
f
our products or components. Our products are complex and diffi
f cult to manufact
f
ur
t
e. Finding alternate
facilities and obtaining FDA app
a
roval for
f
the manufact
f
ur
t
e of the INTERCEPT Blood System at such facilities would be costly and time-
consuming and would negatively impact our ability to generate product revenue from the sale of our platelet, plasma or cryoprecipitation
system in the U.S. and achieve operating profitabi
a lity. Our red blood cell system also needs to be manufac
f
tured in FDA-approved
facilities, several of which are not currently FDA-approved. Failure of our suppl
u
iers to meet cGMP regulations and fai
f lure to obtain or
maintain FDA app
a
roval will negatively impact our ability to achieve FDA approval for
f
our products or may require that we identify,
f
qualify a
f
nd contract with alternative suppliers, if they are availabl
a e, which would be time consuming, costly and result in fur
f
ther approval
delays.
We, our third-party suppliers and third-party suppl
u
iers of products or components used by our customers in combination with our
products are also required to comply with the cGMP and QSR requirements, which cover the methods and documentation of the design,
testing, production, control, quality assurance, labe
a
ling, packaging, sterilization, storage and shipping of products, all of which is costly
and may require updating periodically. The FDA and other regulatory a
r
uthorities, including international regulatory a
r
uthorities and
Notifie
f d Bodies, audit compliance with cGMP and QSR requirements through periodic announced and unannounced inspections of
manufac
f
turing and other facilities. These audits and inspections may be conducted at any time. The manufac
f
turing facility which
produces our platelet and plasma systems was recently audited by the FDA. While there were not objectionabl
a e conditions observed
during the audit, the FDA or other regulatory a
r
uthorities, including third country authorities and Notifie
f d Bodies, may inspect and audit
facilities manufact
f
ur
t
ing our products or components or products and components of third-party suppl
u
iers used by our customers in
combination with our products at any time. Complying with and resolving any audit fin
f dings may result in additional costs, changes to
our manufact
f
ur
t
ers’ quality management systems or both. Failure to timely resolve and comply to audit fin
f dings, if any, may result in
enforcement actions and may result in a disrupt
u ion to the suppl
u
y of our products or other products or components used by our customers
in combination with our products. In any event, if we or our suppl
u
iers fail to adhere to cGMP and QSR requirements, have significant
non-compliance issues or fail to timely and adequately respond to any adverse inspectional observations or product safet
f y issues, or if
any corrective action plan that we or our suppl
u
iers propose in response to observed defic
f iencies is not sufficient, the FDA or other
regulatory a
r
gency could take enfor
f
cement action against us, which could delay production of our products and may include:
•
untitled letters, warning letters, fines, inju
n nctions, consent decrees and civil penalties;
•
unanticipated expenditures to address or defen
f
d such actions;
•
customer notific
f ations or repair, replacement, refunds
f
, recall, detention or seizure of our products;
•
operating restrictions or partial suspension or total shutdown of production;

36
•
refusing or delaying our requests for premarket approval of new products or modified products;
•
withdrawing, suspension or variation of marketing appr
a
ovals or CE Certific
f ates of Confor
f
mity that have already been
granted;
•
refusal to grant export or import appr
a
oval for
f
our products; or
•
criminal prosecution.
Any of the foregoing actions could have a material adverse effect on our reputation, business, financial condition, results of operations
and growth prospects.
If we modify
i
our FDA
F
-appr
a
oved or CE Marked products, w
s
e may need to seek additi
i onal approvals,
l
or certifi
i cation, which, if not
granted, would p
l
revent us fro
f
m sellin
l
g our modifi
i ed products.
t
Any modifications to the platelet, plasma or cryopr
r
ecipitation systems could be determined to significantly affect their safet
f y or
effe
f ctiveness, including significant design and manufact
f
ur
t
ing changes, or determined to constitut
t e a majo
a r change in their intended use,
manufac
f
ture, design, components, or technology which would require approval of a new premarket approval appl
a
ication, or PMA, or
PMA supplement. Further, any modification to our plasma system may have an impact on the cryoprecipitation system, which may
similarly require approval of a new PMA suppl
u
ement. However, certain changes to a PMA-approved device do not require subm
u
ission
and appr
a
oval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The FDA requires
every s
r
upplier to make this determination in the first instance, but the FDA may review any supplier’s decision. The FDA may not agree
with our decisions regarding whether new submissions or approvals are necessary. Our products could be subject to recall if the FDA
determines, for
f
any reason, that our products are not safe or effe
f ctive or that appr
a
opriate regulatory s
r
ubmissions were not made. If new
regulatory a
r
ppr
a
ovals are required, this could delay or preclude our ability to market the modified system. For example, we are
redesigning the illuminators used in the platelet and plasma systems and may need to further redesign the illuminator. We will need to
obtain regulatory a
r
ppr
a
oval of any future redesign of the illuminator befor
f
e it can be commercialized.
We understand that we will be required to obtain new PMAs for our INTERCEPT Blood System for Platelets and for
f
Plasma with our
new LED-based illuminator. We are currently working with the FDA to understand the data requirements for
f
those PMAs. If we are
unabl
a e to generate the required data for
f
new PMAs, use of INTERCEPT in the United States will be limited to continued use with the
existing illuminator, which we have a limited number of devices availabl
a e and for which we have a limited time that we can continue to
suppor
u
t and maintain.
Generating data from the new illuminator may be time consuming, expensive or unsuccessful
f . In addition, in order to address the entire
market in the U.S., customers will need to change their operating practices to confor
f
m to our product specifications or we will need to
obtain appr
a
oval for
f
additional config
f urations of the platelet system, as discussed in greater detail above under “Risk
i
s R
k
elated to Our
Business and Industry—
r
Our platelet and plasma products and product candidates are not compatible with some collection, production
and storage methods or combinations thereofo ”
f
Should we decide not to pursue or otherwise fail to obtain FDA and fore
f
ign regulatory
r
approvals of any new config
f urations, our ability to generate produc
d
t revenue from sales of the platelet system may be impaired and our
growth prospects may be materially and adversely affe
f cted.
In addition, if the FDA or other regulatory o
r
r accrediting body were to mandate safety interventions or modify existing requirements for
f
safety interventions, including safety interventions involving the use of pathogen reduc
d
tion technology, when we had not received
approval for
f
all operational config
f urations, the market to which we could sell our products may be limited until we obtain such appr
a
ovals,
if ever, or may be permanently impaired if competing options are more broadly availabl
a e.
For those products sold in the EU, we must notify o
f
ur Notifie
f d Body if significant changes are made to the products or if there are
subs
u
tantial changes to our quality assurance systems affe
f cting those products. Obtaining new related CE Certific
f ates of Conformity or
variation of existing Certific
f ates can be a time-consuming process, and delays in obtaining required fut
f ur
t
e clearances, certific
f ations or
approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in tur
t
n would harm our
future growth.
We are subje
b ct to federal, stat
t e a
t
nd foreign l
g
aw
l
s governi
r
ng
i
our business practic
t es which, if violat
l ed
t
, c
d
ould result in substantia
t l
penalties and harm o
r
ur repu
e
tation and busine
i
ss.
In the ordinary c
r
ourse of business, we collect, receive, store, process, generate, use, transfer
f , disclose, make accessible, protect, secure,
dispose of, transmit, and share (collectively, processing) personal data and other sensitive information, including proprietary and
confid
f ential business data, trade secrets, intellectua
t
l property, data we collect about trial participants in connection with clinical trials,
and sensitive third-party data.
Our data processing activities may subj
u ect us to numerous data privacy and security obligations establ
a ished in various laws, regulations,
guidance, industry s
r
tandards, external and internal privacy and security policies, contractua
t
l requirements, and other obligations relating
to data privacy and security, that affect our sales, marketing and other promotional activities by, among other things, limiting the kinds
of financial arrangements we may have with hospitals, healthcare providers or other potential purchasers of our products. These laws

37
are often broadly written, and it is ofte
f n diffi
f cult to determine precisely how these laws will be appl
a
ied to specific circumstances. For
example, within the EU, the control of unlawful marketing activities is largely a matter of national law and regulations in each of the
EU Member States. There are a variety of organizations and entities within EU Member States which monitor perceived unlawful
marketing activities. We could fac
f
e civil, criminal and administrative sanctions if it is determined that we have breached our obligations
in any EU Member State in respect of our marketing activities. Industry a
r
ssociations also closely monitor the activities of member
companies. If these organizations or authorities name us as having breached our obligations under their regulations, rul
r es or standards,
our reputation would suffe
f r and our business and financial condition could be adversely affected.
In addition, there are numerous U.S. federal, state and local healthcare regulatory l
r
aws, and similar foreign laws, including but not
limited to, anti-kickba
k
ck laws, fal
f se claims laws, antitrus
r
t, privacy laws, and transparency laws. Our relationships with healthcare
providers and entities, including but not limited to, hospitals, blood centers, physicians, other healthcare providers, and our customers
are subject to scrutiny under these laws. Violations of these laws can subj
u ect us to significant penalties, including, but not limited to,
administrative, civil and criminal penalties, damages, fines, disgorgement, imprisonment, exclusion fro
f
m participation in federal and
state healthcare programs, including the Medicare and Medicaid programs, or equivalent foreign programs, additional reporting
requirements and/or oversight if we become subj
u ect to a corporate integrity agreement or similar agreement to resolve allegations of
non-compliance with these laws, and the curtailment of our operations. The laws that may affect our ability to operate include, but are
not limited to:
•
the fed
f
eral Anti-Kickba
k
ck Statut
t e, which prohibits, among other things, persons and entities fro
f
m knowingly and willfully
offe
f ring, paying, soliciting, or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in
exchange for or to induce, the refer
f ral of an individual for
f
, the purchase, lease, order or recommendation of, any good,
facility, item or service for which payment may be made, in whole or in part, under fed
f
eral healthcare programs such as
Medicare and Medicaid;
•
federal fal
f se claims laws, including the civil False Claims Act, which can be enforced by private citizens on behalf of the
government, through civil whistleblower or qui tam actions, and the fed
f
eral civil monetary penalties law, that prohibit,
among other things, knowingly presenting, or causing to be presented, claims for payment or approval from
f
Medicare,
Medicaid or other federal payors that are false or fra
f udulent, or knowingly making a false statement to improperly avoid,
decrease or conceal an obligation to pay money to the federal government, and which may apply to entities that provide
coding and billing advice to customer;
•
the fed
f
eral Health Insurance Portabi
a lity and Accountability Act of 1996, as amended, or HIPAA, which created federal
criminal laws that prohibit, among other things, executing a scheme to defraud any healthcare benefit
f
program, including
private payors, or making materially false statements in connection with the delivery o
r
f, or payment for
f
, healthcare benefits,
items or services relating to healthcare matters;
•
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH,
and their respective implementing regulations, which impose requirements on covered entities, including certain healthcare
providers, health plans and healthcare clearinghouses as well as their business associates and their subc
u
ontractors that create,
receive, maintain or transmit individually identifiable health information for
f
or on behalf of a covered entity, relating to the
privacy, security and transmission of individually identifia
f bl
a e health information, including mandatory contractua
t
l terms as
well as directly applicable privacy and security standards and requirements;
•
the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; and
•
foreign, or U.S. state or local law equivalents of each of the above
a
federal laws, such as anti-kickba
k
ck and fal
f se claims laws
which may apply to items or services reimbursed by any third-party payor, including commercial insurers; laws that require
device and biologics companies to comply with the industry’
r
s voluntary c
r
ompliance guidelines and the relevant compliance
guidance promulgated by the government or otherwise restrict payments that may be made to healthcare providers; laws
that require device and biologics manufact
f
ur
t
ers and distributors to report infor
f
mation related to payments and other transfer
f s
of value to physicians and other healthcare providers or marketing expenditures; and laws governing the privacy and security
of certain health information, many of which diffe
f r fro
f
m each other in significant ways and ofte
f n are not preempted by
HIPAA, thus complicating compliance efforts.
Moreover, our business practices are also subject to regulation by national, regional, state and local agencies, including but not limited
to the Department of Justice, Federal Trade Commission, HHS Offi
f ce of Inspector General and other regulatory b
r
odies. For example,
on November 29, 2022, we received a civil investigative demand, or the CID, fro
f
m the U.S. Department of Justice Antitrust Division,
or the Division, inquiring regarding contracting and information exchange practices related to our products and services. The Division
closed its investigation on January 15, 2025 without initiating any claim or proceeding against us relating to these matters. We are
currently and may again in the future become subj
u ect to similar investigations by other state or federal government agencies. If the
outcome of the CID or any such similar investigation is unfav
f
orable to us, it may result in changes to our business practices, fin
f es,
penalties or administrative sanctions against us, negative publicity and/or other negative actions that could materially harm our financial

38
performance and results of operations, as well as our stock price. In addition, we incurred significant costs in connection with the CID,
and we could incur significant costs in connection with potential future similar investigations, which could harm our ability to achieve
our financial performance objectives.
In addition, there has been a trend of increased U.S. federal, state and local regulation of payments and transfer
f s of value provided to
healthcare professionals or entities. The Physician Payments Sunshine Act, imposes annual reporting requirements on device and
biologics manufact
f
ur
t
ers and distributors for
f
which payment is availabl
a e under Medicare, Medicaid, or the Children’s Health Insurance
Program, with specific exceptions, to track and annually report to the Centers for
f
Medicare & Medicaid Services, or CMS, for
f
payments
and other transfer
f s of value provided by them, directly or indirectly, to physicians (defin
f ed to include doctors, dentists, optometrists,
podiatrists and chiropractors), other healthcare profes
f
sionals (such as physician assistants and nurse practitioners) and teaching hospitals,
as well as ownership and investment interests held by physicians and their family members. Some states, such as Califor
f
nia and
Connecticut, also mandate implementation of commercial compliance programs, and other states, such as Massachusetts and Vermont,
impose restrictions on device and biologics manufact
f
ur
t
er and distributor marketing practices and tracking and reporting of gifts,
compensation and other remuneration to healthcare professionals and entities. The shifting commercial compliance environment and
the need to build and maintain robust and expandabl
a e systems to comply with different compliance and reporting requirements in
multiple jurisdictions increase the possibility that we may fai
f l to comply ful
f ly with one or more of these requirements.
Our research, development and clinical programs, as well as our manufac
f
turing and marketing operations, are subj
u ect to extensive
regulation in countries outside of the U.S.
In the European Economic Area (“EEA”) (comprised of the 27 EU Member States, plus Iceland, Lichtenstein and Norway), Regulation
(EU) 2017/745 on Medical Devices, or the Medical Device Regulation (“MDR”) and its associated guidance documents and harmonized
standards govern many aspects of the regulation of medical devices. This includes device design and development, preclinical and
clinical or performance testing, premarket confor
f
mity assessment, registration and listing, manufact
f
ur
t
ing, labe
a
ling, storage, claims, sales
and distribution, export and import and post-market surveillance, vigilance, and market surveillance.
Medical devices must comply with the General Safety and Performance Requirements (“GSPRs”), set out in Annex I to the Medical
Device Regulation. Compliance with these requirements is a prerequisite to affi
f xing the CE mark to devices, without which they cannot
be marketed or sold in the EEA. To demonstrate compliance with the GSPRs provided in the Medical Device Regulation and obtain the
right to affi
f x the CE mark, medical devices manufactur
t
ers must conduct a confor
f
mity assessment procedur
d
e, which varies according to
the type of medical device and its classification. Apart fro
f
m low-risk medical devices (Class I with no measuring func
f
tion and which
are not sterile), in relation to which the manufact
f
ur
t
er may issue an EU Declaration of Confor
f
mity based on a self-a
f ssessment of the
confor
f
mity of its products with the GSPRs, a confor
f
mity assessment procedur
d
e requires review by a Notifie
f d Body. A Notifie
f d Body is
an organization designated by a Competent Authority of an EEA country to conduct confor
f
mity assessments. Depending on the relevant
confor
f
mity assessment procedur
d
e, the Notifie
f d Body audits and examines the technical documentation and the quality system for the
manufac
f
ture, design and final inspection of the medical device. Following a successful
f
assessment process, the Notifie
f d Body issues a
CE Certific
f ate of Confor
f
mity. This Certificate and completion of the related confor
f
mity assessment process entitles the manufact
f
ur
t
er to
affi
f x the CE mark to its medical devices after having prepared and signed a related EU Declaration of Confor
f
mity.
As a general rule, demonstration of confor
f
mity of medical devices and their manufac
f
turers with the GSPRs must include the evaluation
of clinical data suppor
u
ting the safet
f y and performance of the products during normal conditions of use. Specifically, a manufact
f
ur
t
er
must demonstrate that the device achieves its intended performance during normal conditions of use and that the known and foreseeable
risks, and any adverse events, are minimized and acceptabl
a e when weighed against the benefits
f
of its intended performance, and that
any claims made about
a
the performance and safety of the device (e.g., product labeling and instructions for use) are suppor
u
ted by suitabl
a e
evidence. This assessment must be based on clinical data, which can be obtained fro
f
m (1) clinical investigations conducted on the
devices being assessed, (2) scientific literatur
t
e fro
f
m similar devices whose equivalence with the assessed device can be demonstrated
or (3) both clinical investigations and scientific
f
literature. Moreover, afte
f r a device is placed on the market, it remains subject to
significant regulatory r
r
equirements that must commonly be ful
f filled by the manufac
f
turer or on their behalf.f
The Medical Device Regulation includes a number of transitional provisions. Manufact
f
ur
t
ers of medical devices may only benefit
f
from
the transitional provisions if certain conditions are ful
f filled. If we or our products fail to comply with the requirements of MDR, then
our products may not be permitted to be sold in the EU or other jurisdictions that recognize CE Certific
f ate of Confor
f
mity and our results
of operations and fin
f ancial projections would be adversely affe
f cted.
Outside the United States, interactions between medical devices companies and health care professionals are also governed by strict
laws, such as national anti-bribery l
r
aws of European countries, national sunshine rules, regulations, industry s
r
elf-regulation codes of
conduct and physicians’ codes of professional conduct. Failure to comply with these requirements could result in reputational risk,
public reprimands, administrative penalties, fines or imprisonment.
We are also subject to domestic and for
f
eign laws and regulations covering data privacy and the protection of health-related and other
personal infor
f
mation. Domestic privacy and data security laws are complex and changing rapi
a dly. Many states have enacted laws
regulating the online collection, use and disclosure of personal infor
f
mation and requiring that companies implement reasonabl
a e data
security measures. Laws in all states and U.S. territories also require businesses to notify a
f
ffected individuals, governmental entities

39
and/or credit reporting agencies of certain security breaches affe
f cting personal infor
f
mation. These laws are not consistent, and
compliance with them in the event of a widespread data breach is complex and costly.
In the U.S., the Califor
f
nia Consumer Privacy Act of 2018, or CCPA, gives Califor
f
nia residents expanded rights related to their personal
information, including the right to access and delete their personal infor
f
mation, and receive details about how their personal inform
f
ation
is used and shared. These create an additional burden on us, as do the restrictions on “sales” of personal infor
f
mation that allow
Califor
f
nians to opt-out of certain sharing of their personal infor
f
mation. The CCPA prohibits discrimination against individuals who
exercise their privacy rights, provides for
f
civil penalties for
f
violations and creates a private right of action for
f
data breaches that is
expected to increase data breach litigation. Similarly, the Califor
f
nia Privacy Rights Act, or CPRA,
R
which became effective on January
1, 2023, restricts use of certain categories of sensitive personal infor
f
mation; further restricts the use of cross-contextual advertising
techniques; establ
a ishes restrictions on the retention of personal infor
f
mation; expands the types of data breaches subject to the private
right of action; and establishes the Califor
f
nia Privacy Protection Agency to implement and enfor
f
ce the new law, as well as impose
administrative fin
f es. Other states have also enacted data privacy laws. For example, Virginia passed the Consumer Data Protection Act,
and Colorado passed the Colorado Privacy Act, both of which differ
f
from the CPRA and also became effective in 2023. We are or may
become subj
u ect to new, additional, different or changed data privacy laws, at the state or other levels of government, and correspondingly
the risk of enfor
f
cement action against us could increase because we have or may become subject to additional obligations, and the
number of individuals or entities that can initiate actions against us may increase (including individuals, via a private right of action,
and state actors).
In the EEA, the General Data Protection Regulation, or EU GDPR, and in the UK the United Kingdom’s implementation of the EU
GDPR, the UK GDPR, which are wide-ranging in scope, imposes detailed requirements, in particular, in relation to the control over
personal data by individua
d
ls to whom the personal data relates, the information that we must provide to the individua
d
ls, the
documentation we must maintain, the security and confid
f entiality of the personal data, data breach notific
f ation, the legal bases for
f
processing personal data, the exceptions that allow us to process special categories of personal data and the use of third-party processors
in connection with the processing of personal data. The EU GDPR and UK GDPR also imposes strict rules on the transfer
f
of personal
data out of the EEA and United Kingdom respectively, and authorizes the imposition of large penalties for
f
noncompliance, including
the potential for
f
fines of up t
u
o 20 million euros under the EU GDPR, 17.5 million pound sterling under the UK GDPR, or in each case,
4% of the annual global revenues of the non-compliant company, whichever is greater. In addition, companies may face private litigation
related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to
represent their interests.
In the ordinary c
r
ourse of business, we may transfer personal data fro
f
m Europe and other jurisdictions to the United States or other
countries. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer
f
of personal data to
other countries. In particular, the European Economic Area and the United Kingdom have significantly restricted the transfer
f
of personal
data to the United States and other countries whose privacy laws it generally believes are inadequate. Other jurisdictions may adopt
similarly stringent interpretations of their data localization and cross-border data transfer laws. Although there are currently various
mechanisms that may be used to transfer personal data fro
f
m the EEA and UK to the United States in compliance with law, such as the
EEA standard contractua
t
l clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy
Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify c
f
ompliance
and participate in the Framework), these mechanisms are subj
u ect to legal challenges, and there is no assurance that we can satisfy o
f
r
rely on these measures to lawful
f ly transfer
f
personal data to the United States. If there is no lawful manner for
f
us to transfer
f
personal
data from the EEA, the UK or other jurisdictions to the United States, or if the requirements for
f
a legally-compliant transfer
f
are too
onerous, we could face significant adverse consequences, including the interrupt
u ion or degradation of our operations, the need to relocate
part of or all of our business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure
to regulatory a
r
ctions, substantial fin
f es and penalties, the inabi
a lity to transfer
f
data and work with partners, vendors and other third parties,
and injunctions against our processing or transfer
f ring of personal data necessary to operate our business. Additionally, companies that
transfer
f
personal data out of the EEA and UK to other jurisdictions, particularly to the United States, are subject to increased scrut
r iny
from regulators, individual litigants, and activist groups. Some European regulators have ordered certain companies to suspend or
permanently cease certain transfer
f s out of Europe for allegedly violating the GDPR’s cross-border data transfer limitations.
The CCPA, CPRA and similar laws in other states, the EU GDPR, the UK GDPR and other international privacy laws have increased
our responsibility and potential liabi
a lity in relation to personal data that we process compared to prior law, including in clinical trials
and employee data, and we may be required to put in place additional mechanisms to ensure compliance with these laws, which could
divert management’s attention and increase our cost of doing business. However, despite our ongoing effo
f
rts to bring our practices into
compliance with the EU GDPR and the UK GDPR, we may not be successful
f
either due to various factors within our control or other
factors outside our control. It is also possible that local courts and data protection authorities may have different interpretations of
applicable law, leading to potential inconsistencies in appl
a
ication of these laws. If we are unabl
a e to implement sufficient safeg
f
uards to
ensure that our transfer
f s of personal infor
f
mation from the EEA or the UK are lawful
f , we will face
f
increased exposure to regulatory
r
actions, substantial fin
f es, and inju
n nctions against processing personal infor
f
mation fro
f
m the EEA or the UK.

40
Complying with our obligations under app
a
licable privacy laws, regulations, amendments to or re-interpr
r
etations of existing laws and
regulations, and contractua
t
l or other requirements relating to privacy, data protection, data transfer
f s, data localization, or information
security may require us to make changes to our services to enable us or our customers to meet new legal requirements, incur substantial
operational costs, modify our data practices and policies, and restrict or otherwise impact our business operations. Any failure or alleged
failure (including as a result of defic
f iencies in our policies, procedur
d
es or measures relating to privacy, data security, marketing or
communications) by us or by the third parties on which we rely to comply with laws, regulations, policies, legal or contractua
t
l
obligations, industry s
r
tandards or regulatory g
r
uidance relating to privacy or data security, may result in governmental enforcement
actions, including investigations litigation, fines, audits, inspections and other penalties or adverse publicity, additional reporting
requirements and/o
d r oversight, bans on processing personal data and orders to destroy or not use personal data. Any of these events
could have an adverse effect on our reputation, business, or financial condition, including but not limited to: loss of customers;
interrupt
u ions or stoppages in our business operations; inabi
a lity to process personal data or to operate in certain jurisdictions; limited
ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; or subs
u
tantial
changes to our business model or operations. In addition, new regulations, legislative actions or changes in interpr
r
etation of existing
laws or regulations regarding data privacy and security (together with applicable industry s
r
tandards) may increase our costs of doing
business.
We are also subject to the U.S. Foreign Corrupt
u
Practices Act and anti-corrupt
u ion laws, and similar laws with a significant anti-corrupt
u ion
intent in foreign countries. In general, there is a worldwide trend to strengthen anticorrupt
u ion laws and their enfor
f
cement. Any violation
of these laws by us or our agents, distributors or joint ventur
t
e partners could create a substantial liabi
a lity for us, subj
u ect our offi
f cers and
directors to personal liabi
a lity and also cause a loss of reputation in the market. We currently operate in many countries where the public
sector is perceived as being more or highly corrupt
u . Our strategic business plans include expanding our business in regions and countries
that are rated as higher risk for
f
corrupt
u ion activity, such as China, India and Russia. Becoming fam
f
iliar with and implementing the
infrastructur
t
e necessary to comply with laws, rul
r es and regulations applicable to new business activities and mitigate and protect against
corrupt
u ion risks could be quite costly. In addition, failure by us or our agents, distributors or joint ventur
t
e partners to comply with these
laws, rul
r es and regulations could delay our expansion into high-growth markets, could damage market perception of our business and
could adversely affect
f
our existing business operations. Increased business in higher risk countries could also subject us and our offi
f cers
and directors to increased scrut
r iny and increased liabi
a lity.
To enforce compliance with the healthcare regulatory l
r
aws, federal and state enfor
f
cement bodies have increased their scrutiny of
interactions between healthcare companies and healthcare providers, which have led to a number of investigations, prosecutions,
convictions and settlements in the healthcare industry.
r
Any such investigation or settlement could increase our costs or otherwise have
an adverse effect on our business. In addition, most of these laws appl
a
y to not only the actions taken by us, but also actions taken by our
distributors and other third-party agents, and healthcare providers with whom we interact. We have limited knowledge and control over
the business practices of our distributors and agents, and we may face
f
regulatory a
r
ction against us as a result of their actions which could
have a material adverse effect on our reputation, business, results of operations and fin
f ancial condition.
Legi
e sl
i at
l iv
t e, regu
e
latory, o
y
r other health
l
care refo
e
rms may make it more diffi
i
cult and costly for us to o
t
btai
t n r
i
egulat
l or
t
y a
r
ppr
a
oval or CE
Certif
t ic
f ates
t
of Confor
f
mity
r
for our products a
t
nd to produce, market and dis
d tribute o
t
ur products a
t
ft
a er
t
approval or certif
t ic
f atio
t n isi
obtai
t ne
i
d.
Regulatory g
r
uidance and regulations are often revised or reinterpr
r
eted by the regulatory a
r
gencies in ways that may significantly affe
f ct
our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs
or lengthen review times of our products. Delays in receipt of, o
f
r fai
f lure to receive, regulatory a
r
ppr
a
ovals or certific
f ation for
f
our new
products or product configurations would have a material adverse effect on our business, results of operations and fin
f ancial condition.
Federal and state governments in the U.S. have enacted legislation to overhaul the nation’s healthcare system. While the goal of
healthcare refor
f
m is to expand coverage to more individuals, it also involves increased government price controls, additional regulatory
r
mandates and other measures designed to constrain medical costs. The Patient Protection and Affo
f
rdable Care Act, or ACA, continues
to significantly impact the health care industry.
r
Among other things, the ACA:
•
establ
a ished a Patient-Centered Outcomes Research Institute to oversee and identify p
f
riorities in comparative clinical
effe
f ctiveness research in an effo
f
rt to coordinate and develop such research; and
•
implemented payment system refor
f
ms including a national pilot program on payment bundling to encourage hospitals,
physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through
bundled payment models.
There have been amendments and executive, judicial and Congressional challenges to numerous provisions of the ACA. For example,
on August 16, 2022, the Infla
f tion Reduction Act of 2022, or IRA,
R
was signed into law, which among other things, extends enhanced
subs
u
idies for
f
individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates
the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary m
r
aximum out-of-
pocket cost and creating a manufact
f
ur
t
er discount program. It is unclear how any such challenges and the healthcare reform effort
f
s of
the second Trum
r
p administration will impact ACA and our business. The implementation of new health care legislation could result in

41
significant changes to the health care system, which could have a material adverse effect on our business, results of operations, fin
f ancial
condition and growth prospects.
More recently, there has been heightened governmental scrutiny in the U.S. to control the rising cost of healthcare. Such scrutiny has
resulted in several recent presidential executive orders, congressional inquiries and fed
f
eral and state legislative activity designed to,
among other things, bring more transparency to pricing and reform government program reimbursement methodologies for healthcare
products. State legislatur
t
es are also increasingly passing legislation and implementing regulations designed to control the cost of
healthcare, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost
disclosure and transparency measures.
We cannot predict the likelihood, nature, or extent of health reform initiatives that may arise from fut
f ur
t
e legislation or administrative
action. We expect that additional U.S. fed
f
eral and state and for
f
eign healthcare refor
f
m measures will be adopted in the fut
f ur
t
e, any of
which could limit the amounts that governments will pay for
f
healthcare products and services, which could result in reduc
d
ed demand
for our products or additional pricing pressure.
The changes to the regulatory s
r
ystem implemented in the EU by the MDR include stricter requirements for
f
clinical evidence and pre-
market assessment of safet
f y and performance, new classifications to indicate risk levels, requirements for
f
third-party testing by Notified
Bodies, additional requirements for
f
the quality management system, traceability of products and transparency as well a refined
responsibility of economic operators. We are also required to provide clinical data in the for
f
m of a clinical evaluation report. Fulfil
f ment
of the obligations imposed by the MDR may cause us to incur substantial costs. We may be unabl
a e to ful
f fil these obligations, or our
Notifie
f d Body, where appl
a
icable, may consider that we have not adequately demonstrated compliance with our related obligations to
merit a CE Certific
f ate of Confor
f
mity on the basis of the MDR or continued certific
f ation under the MDR.
Moreover, in the EU some EU Member states may, after a medical device is CE marked, require the completion of additional studies
that compare the cost-effe
f ctiveness of a particular medical device candidate to currently availabl
a e therapi
a es. This Health Technology
Assessment, or HTA process, which is currently governed by the national laws of the individual EU Member States, is the procedur
d
e
according to which the assessment of the public health impact, therape
a
utic impact and the economic and societal impact of use of a
given medical device in the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific
medical device will ofte
f n influ
f ence the pricing and reimbursement status
t
granted to these products by the competent authorities of
individual EU Member States. In December 202, Regulation No 2021/2282 on HTA amending Directive 2011/24/EU, was adopted in
the EU. This Regulation, which has applied as of January 12, 2025, is intended to boost cooperation among EU Member States in
assessing health technologies, and, where the medical device is a class IIb or class III medical device or an in-vitro diagnostic medical
device of class D, providing the basis for cooperation at EU level for joint clinical assessments in these areas. If the conclusion of these
assessments are negative, or compare our products unfav
f
orably with competing products, this may impact our pricing and reimbursement
status
t
. If we are unabl
a e to obtain or maintain fav
f
orable pricing and reimbursement status
t
in EU Member States for our medical devices
or medical devices that we may successful
f ly develop and for which we may obtain certific
f ation, any anticipated revenue from and
growth prospects for
f
those products in the EU could be negatively affected.
Risks Related to Government Contracts
A signi
g
fi
i cant portion of the fun
f
ding
i
for the
t
developm
o
ent of t
o
he
t
red blood cell s
l
ys
s
tem has come and is e
i
xpe
e
cted
t
to contin
t
ue to come
from our BARD
B
A a
D
gr
a
eements,
t
and if B
i
ARD
B
A w
D
ere to e
t
liminate,
t
reduce, delay,
a
or object to extensions for fund
f
in
d
g of o
o
ur agreements,
t
it would h
l
ave a sign
i
ific
f ant, nega
e
tive imp
i
act on our government contract revenues and cash flow
l
s, and we may be forced to s
t
uspe
s
nd
or terminate o
t
ur U.S. red blood cell d
l
ev
d
elopm
l
ent progr
o
am or obtai
t n a
i
lternativ
t e sources of fu
f
ndin
d
g. Our abili
i ty
i
to be paid by t
b
he
t
DoD
o
is predic
d ated
t
on our abilit
i
y t
t
o a
t
chieve the stated mileston
t
es in the agr
a
eement and for the
t
DoD t
o
o a
t
gr
a
ee with
i
the successful
f
completion
of each.
We anticipate that a significant portion of the funding for the development of the red blood cell system in the United States will come
from our agreements with BARDA. The original agreement that we entered into in 2016, or the 2016 Agreement, including its
subs
u
equent modifications, provides for
f
reimbursement of certain expenses incurred by us for
f
up to approximately $270.2 million to
suppor
u
t the development of the red blood cell system. However, the 2016 Agreement with BARDA only reimburses certain specified
development and clinical activities that have been authorized by BARDA pursuant to the base period and certain options of the 2016
Agreement and the potential exercise of subsequent option periods. To date, BARDA has exercised appr
a
oximately $185.5 million under
the base period of the 2016 Agreement and associated options. BARDA will no longer exercise any of the remaining options under the
2016 BARDA Agreement. In September 2024, we entered into a new agreement with BARDA, the 2024 Agreement, which includes
potential funding of up to approximately $188.4 million under a base period and subsequent option periods, similar to the 2016
Agreement. Our abi
a lity to access the full amount availabl
a e under the 2024 Agreement is dependent on our success in completing required
tasks under the base period and each option period, if and to the extent any option periods are exercised by BARDA, which it may do
or not do in its sole discretion. In addition, BARDA is entitled to terminate either of our BARDA agreements for convenience at any
time, in whole or in part, and is not required to provide continued fundi
f
ng beyond reimbursement of amounts currently incurred and
obligated by us as a result of contract performance. We understand that the 2016 Agreement with BARDA will expire in 2026 and the
2024 Agreement with BARDA will expire in 2030. Under both BARDA agreements, activities covered under the base period and

42
exercised option periods may ultimately take longer than is allowed or cost more than is covered by the respective BARDA agreements,
and if we are unabl
a e to secure additional fundi
f
ng or allow for
f
additional time for completion, we would have to bear the cost to complete
the activities or terminate the activities befor
f
e completion. In addition, should there be a temporary f
r
undi
f
ng shortfal
f l with any of the
activities contemplated, we may need to cease, delay or defer
f
completion of the activities until the fundi
f
ng shortfal
f l is resolved, if ever.
For example, we know that certain options are expected to run out of approved amounts under the 2016 Agreement in the near-term.
We are uncertain how future U.S. government budgets, executive actions, and debt ceiling negotiations will affe
f ct BARDA fundi
f
ng.
We have hired and maintain staffi
f ng, as well as having entered into agreements with third parties to perform activities associated with
our BARDA agreements. Should we be unabl
a e to ful
f ly utilize the personnel or third parties as planned, either because of BARDA
funding or time limitations, or other reasons, we may be forced to bear costs that we had anticipated would be covered under our BARDA
agreements. Moreover, the continuation of our BARDA agreements depends in large part on our ability to meet development milestones
previously agreed to with BARDA and on our compliance with certain operating procedur
d
es and protocols. BARDA may suspend or
terminate our agreements should we fai
f l to achieve key milestones, or fail to comply with the operating procedur
d
es and processes
approved by BARDA and its audit agency. There can be no assurance that we will be able to achieve these milestones or continue to
comply with these procedures and protocols. Our ability to meet the expectations of BARDA under our agreements is largely dependent
on our ability to attract, hire and retain personnel with competencies that are in short supply. In addition, in many instances we must
identify third-party suppliers, negotiate terms acceptable to us and BARDA and ensure ongoing compliance by these suppl
u
iers with the
obligations covered by our BARDA agreements. If we are unabl
a e to provide adequate suppl
u
ier oversight or if suppl
u
iers are unabl
a e to
comply with the requirements of the agreements, our ability to meet the anticipated milestones may be impaired.
There can also be no assurance that our BARDA agreements will not be terminated, that our BARDA agreements will be extended for
f
existing exercised options or through the exercise of subsequent option periods, that any such extensions would be on terms favorable
to us, or that we will otherwise obtain the funding that we anticipate to obtain under our agreements with BARDA. In addition, access
to federal contracts is subject to the authorization of funds
f
and appr
a
oval of our research plans by various organizations within the fed
f
eral
government, including the U.S. Congress. The general economic environment and uncertainty, coupled with tight federal budgets, and
the lack of congressional unanimity on the national debt ceiling and budget, has led to ambiguity regarding the amount availabl
a e for
f
government funding. The U.S. Federal Government has imposed a standardized indirect cost rate on grants administered by the National
Institutes of Health. The standardized rates are significantly lower than our current audited indirect rates. While our contracts with
BARDA are not currently impacted by these orders, should the U.S. Federal government impose similar restrictions, we would have to
absorb many of our indirect costs which would adversely affe
f ct our operating results. Moreover, changes in government budgets and
agendas may result in a decreased and deprioritized emphasis on supporting the development of pathogen reduc
d
tion technology. While
BARDA has provided fundi
f
ng for and has indicated a potential for
f
future funding, the availabi
a lity and foc
f
us for any BARDA fundi
f
ng
will likely be fin
f ite and may require us to compete with other technologies, both similar and disparate. Furthermore, funding limitations
may require certain activities to slow or be deferred which may be impractical to do. In addition, if we are unabl
a e to successful
f ly
complete contemplated milestones, our agreements with BARDA will be severely limited in scope or could be terminated altogether,
and our ability to complete the development activities required for
f
licensure in the U.S. may require additional capital beyond which we
currently have. If our BARDA agreements are terminated or suspended, if there is any reduction or delay in funding under our BARDA
agreements, or if BARDA determines not to exercise some or all of the options provided for
f
under the agreements, our revenues and
cash flo
f ws would be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not
be availabl
a e on non-dilutive terms, terms favorable to us or at all. If alternative sources of fundi
f
ng are not availabl
a e, or if we determine
that the cost of alternative availabl
a e capital is too high, we may be for
f
ced to suspend or terminate development activities related to the
red blood cell system in the U.S. Furthermore, should we be unabl
a e to deploy personnel or derive a benefit
f
from fix
f ed study
t
costs or
generate data from clinical sites and studi
t
es reimbursed by BARDA, our cash flo
f ws would be negatively impacted, or we may have to
initiate furloughs and layoffs
f
which would likely prove disrup
r
tive to our management and operations. This in tur
t
n would impair our
ability to complete ongoing studi
t
es or commence new studi
t
es.
In addition, under our BARDA agreements, BARDA will regularly review our development efforts and clinical activities. Under certain
circumstances, BARDA may advise us to delay certain activities and invest additional time and resources befor
f
e proceeding. If we
follow such BARDA advice, overall red blood cell program delays and costs associated with additional resources for which we had not
planned may result. Also, the costs associated with following such advice may or may not be reimbursed by BARDA under our
agreements. Finally, we may decide not to follow the advice provided by BARDA and instead pursue activities that we believe are in
the best interests of our red blood cell program and our business, even if BARDA would not reimburse us under our agreements.
We are reimbursed for
f
costs and are compensated by the DoD based on achievement of stated milestones in the agreement. In order for
f
the DoD to pay us, they must agree on the successful
f
completion of each milestone. Should we be unsuccessful in satisfactorily
completing the stated milestones or if we encounter delays or disputes with the DoD, our cash flo
f ws and anticipated results of operations
will be negatively impacted.
Unfa
n
vorable p
l
rovisi
i ons in g
i
overnm
r
ent contracts, i
s nc
i
luding
i
in our contracts with
i
BARDA,
D
FDA a
D
nd DoD,
o
may h
a
arm o
r
ur busine
i
ss,
fina
i
ncial conditi
i on and ope
o
rating
i
results.
t

43
U.S. government contracts typically contain unfav
f
orable provisions and are subj
u ect to audit and modification by the government at its
sole discretion, which will subject us to additional risks. For example, under our agreements with BARDA, the U.S. government has the
power to unilaterally:
•
audit and object to any BARDA agreement-related costs and fees
f
on grounds that they are not allowabl
a e under the Federal
Acquisition Regulation, or FAR, and require us to reimburse all such costs and fees
f
;
•
suspend or prevent us for a set period of time fro
f
m receiving new contracts or grants or extending our existing agreements
based on violations or suspected violations of laws or regulations;
•
claim nonexclusive, nontransferabl
a e rights to product manufact
f
ur
t
ed and intellectua
t
l property developed under the BARDA
agreements and may, under certain circumstances involving public health and safet
f y, license such inventions to third parties
without our consent;
•
impose restrictions on indirect rates that may be applied to contracts with the federal government;
•
cancel, terminate or suspend our BARDA agreements based on violations or suspected violations of laws or regulations;
•
terminate our BARDA agreements in whole or in part for
f
the convenience of the government for any reason or no reason,
including if funds become unavailabl
a e to the U.S. Department of Health and Human Services’ Office of the Assistant
Secretary f
r
or
f
Preparedness and Response;
•
reduce the scope and value of our BARDA agreements;
•
decline to exercise an option to continue the BARDA agreements;
•
direct the course of the development of the red blood cell system in a manner not chosen by us;
•
require us to perform the option periods provided for under the BARDA agreements even if doing so may cause us to forego
or delay the pursuit of other red blood cell program opportunities with greater commercial potential;
•
take actions that result in a longer development timeline than expected;
•
limit the government’s financial liabi
a lity to amounts appr
a
opriated by the U.S. Congress on a fiscal-year basis, thereby
leaving some uncertainty about the fut
f ur
t
e availabi
a lity of funding for the red blood cell program even afte
f r it has been funded
for an initial period; and
•
change certain terms and conditions in our BARDA agreements.
Generally, government contracts, including our agreements with BARDA, the FDA and the DoD, contain provisions permitting
unilateral termination or modification, in whole or in part, at the U.S. government’s convenience. Termination-for-convenience
provisions generally enabl
a e us to recover only our costs incurred or committed (plus a portion of the agreed fee) and settlement expenses
on the work completed prior to termination. Except for
f
the amount of services received by the government, termination-for-defau
f
lt
provisions do not permit recovery of fees. In addition, in the event of termination or upon
u
expiration of our BARDA agreements, the
U.S. government may dispute wind-down and termination costs and may question prior expenses under the contract and deny payment
of those expenses. Should we choose to challenge the U.S. government for denying certain payments under our BARDA agreements,
such a challenge could subject us to subs
u
tantial additional expenses that we may or may not recover. Further, if any of our government
contracts are terminated for convenience, or if we defau
f
lt by failing to perform in accordance with the contract schedule and terms, a
significant negative impact on our cash flo
f ws and operations could result. Our abi
a lity to receive funding under our contract with DoD
for the development of pathogen reduc
d
ed, lyophilized cryopr
r
ecipitate is based on achievement of milestones which cannot be guaranteed.
If we are unabl
a e to achieve any of those milestones, funding may be limited, less than expected, or non-existent for that particular
milestone, which in all cases would negatively impact our cash flo
f ws and fin
f ancial results.
In addition, government contracts normally contain additional requirements that may increase our costs of doing business and expose
us to liabi
a lity for fai
f lure to comply with these terms and conditions. These requirements include, for
f
example:
•
specialized accounting systems unique to government contracts;
•
mandatory financial audits and potential liabi
a lity for price adju
d stments or recoupment of government funds afte
f r such funds
f
have been spent;
•
public disclosures of certain contract information, which may enable competitors to gain insights into our research program;
•
mandatory internal control systems and policies; and
•
mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affi
f rmative action
programs and environmental compliance requirements.

44
If we fail to maintain compliance with these requirements, we may be subject to potential liability and to the termination of our
government contracts.
Furthermore, we have entered into and will continue to enter into agreements and subcontracts with third parties, including suppliers,
consultants and other third-party contractors, in order to satisfy our contractua
t
l obligations under our government contracts. Negotiating
and entering into such arrangements can be time-consuming and we may not be able to reach agreement with such third parties. Any
such agreement must also be compliant with the terms of our government contracts. Any delay or inability to enter into such
arrangements or entering into such arrangements in a manner that is non-compliant with the terms of our contract, may result in violations
of our government contracts.
To ensure proper administration of our government contracts, including management of third-party suppliers, consultants or contractors,
we must invest and commit resources to undertake significant compliance activities. The diversion of resources from our development
and commercial programs to these compliance activities, as well as the exercise by the U.S. government of any rights under these
provisions, could materially harm our business.
Laws and regulat
l io
t ns affe
f ctin
t
g governm
r
ent contracts, i
s nc
i
luding
i
our agr
a
eements with
i
BARDA,
D
FDA a
D
nd DoD,
o
make it more costly
t
and dif
d fi
f cult for us to s
t
uccessful
f
ly
l
conduct our busine
i
ss. Fai
F lu
i
re to comply with
i
laws and regulat
l io
t ns could r
l
esult i
l n s
i
igni
g
fi
i cant civili
and crimin
i
al penaltie
t s and adverse
r
ly affe
f ct our business.
We must comply with numerous laws and regulations relating to the administration and performance of our agreements. Among the
most significant government contracting regulations are:
•
the FAR and agency-specific regulations suppl
u
emental to the FAR, which comprehensively regulate the procurement,
formation, administration and performance of government contracts;
•
the business ethics and public integrity obligations, which govern conflic
f
ts of interest and the hiring of former government
employees, restrict the granting of gratuities and funding of lobbying activities and incorpor
r
ate other requirements such as
the Anti-Kickba
k
ck Statut
t e, the Procurement Integrity Act, the False Claims Act and the U.S. Foreign Corrupt Practices Act;
•
export and import control laws and regulations; and
•
laws, regulations and executive orders restricting the exportation of certain products and technical data.
In addition, as a U.S. government contractor, we are required to comply with appl
a
icable laws, regulations and standards relating to our
accounting practices and are subj
u ect to periodic audits and reviews. As part of any such audit or review, the U.S. government may review
the adequacy of, a
f
nd our compliance with, our internal control systems and policies, including those relating to our purchasing, property,
estimating, compensation and management infor
f
mation systems. Based on the results of its audits, the U.S. government may adjust our
agreement-related costs and fees
f
, including allocated indirect costs. This adju
d stment could impact the amount of revenues reported on a
historic basis and could impact our cash flo
f ws under the contract prospectively. In addition, in the event that the government determines
that certain costs and fee
f
s were unallowabl
a e or determines that the allocated indirect cost rate was higher than the actua
t
l indirect cost
rate, the government would be entitled to recoup any overpayment from us as a result. In addition, if an audit or review uncovers any
improper or illegal activity, we may be subj
u ect to civil and criminal penalties and administrative sanctions, including termination of our
agreements, for
f
feitur
t
e of profits, suspension of payments, fines and suspension or prohibition fro
f
m doing business with the U.S.
government. We could also suffer serious harm to our reputation if allegations of impropriety were made against us, which could cause
our stock price to decline. In addition, under U.S. government purchasing regulations, some of our costs may not be reimbursabl
a e or
allowed under our contracts. Moreover, as a U.S. government contractor, we maintain plans to ensure compliance with nondiscrimination
and regulatory r
r
equirements for
f
qualifie
f d employees on the basis of gender, race, disabi
a lity and veteran status
t
. Consequently, we may
be subj
u ect to executive orders and regulatory c
r
hanges affecting various aspects of our operations, including compliance with
nondiscrimination plans. Any required elimination or modification of such plans in response to new executive orders could pose
challenges in hiring or retaining employees and may lead to other adverse operational impacts. Failure to comply with these requirements
could expose us to administrative, civil, or criminal liabi
a lities, including fines, penalties, repayments or suspension or debarment fro
f
m
eligibility from fut
f ur
t
e U.S. government contracts. Further, as a U.S. government contractor, we are subj
u ect to an increased risk of
investigations, criminal prosecution, civil fra
f ud, whistleblower lawsuits and other legal actions and liabi
a lities as compared to solely
private sector commercial companies.
Risks Related to Our Reliance on Third Parties
We rely on third parties to market, s
t
ell,
l
dist
i ri
t bute and maint
i
ai
t n o
i
ur products a
t
nd to maintain custom
t
er relationships in c
i
ertain
countri
t es.
We have entered into distribution agreements, generally on a geographically exclusive basis, with distributors in certain regions. We
rely on these distributors to obtain and maintain any necessary in-country regulatory a
r
ppr
a
ovals, as well as market and sell the
INTERCEPT Blood System, provide customer and technical produc
d
t support, maintain inventories, and adhere to our quality system in
all material respects, among other activities. Generally, our distribution agreements require distributors to purchase minimum quantities
in a given year over the term of the agreement. Failure by our distributors to meet these minimum purchase obligations may adversely

45
affe
f ct our financial condition and results of operations. In addition, failure by our distributors to provide an accurate forecast impacts
our ability to predict the timing of product revenue and our ability to accurately forecast our product supply needs. While our contracts
generally require distributors to exercise diligence, these distributors may fail to commercialize the INTERCEPT Blood System in their
respective territories. For example, our distributors may fail to sell product inventory t
r
hey have purchased from us to end customers or
may sell competing products ahead of or in conjunction with INTERCEPT. In addition, initial purchases of illuminators or INTERCEPT
disposable kits by these third parties may not lead to follow-on purchases of platelet and plasma systems’ disposable kits. We have a
finite number of illuminators that can be produced under the current approved config
f uration befor
f
e a redesigned and approved
illuminator is availabl
a e. Our abi
a lity to continue to suppor
u
t and provide spare parts for the existing illuminators is limited. Accordingly,
distributors may need to purchase and either sell or own an equivalent number of new LED-based illuminators that are used in their
geographies in order to continue servicing their customers. Distributors may be unabl
a e to afford to purchase that many new illuminators,
which may require us to provide financing, or may choose to no longer sell INTERCEPT to customers in their geographies. Agreements
with our distributors typically require the distributor to maintain quality standards that are compliant with standards generally accepted
for medical devices. We may be unabl
a e to ensure that our distributors are compliant with such standards. Further, we have limited
visibility into the identity and requirements of blood banking customers these distributors may have. Accordingly, we may be unabl
a e to
ensure our distributors properly maintain illuminators sold or provide quality technical services to the blood banking customers to which
they sell. In Rus
R
sia and Belarus, our illuminators and related spare parts are subject to sanctions. We have a number of installed
illuminators in Rus
R
sia and Belarus that require routine maintenance and replacement of spare parts in order to remain in service. We are
currently permitted to supply illuminators and spare parts to service existing illuminators installed in Russia and Belarus, under certain
conditions and requirements under a special license exception. If the special license exception becomes unavailabl
a e to us or if we are
unabl
a e to meet the conditions and requirements under the special license exception in the future, we will be unabl
a e to sell new
illuminators or provide spare parts to maintain the installed devices in Russia and Belarus, which would impact our financial results.
Additionally, if new sanctions restrictions are placed on our ability to continue to suppor
u
t our business in Rus
R
sia, Belarus, or other CIS
countries, then we may decide to cease that business which would have a detrimental impact on our financial results, our reputation in
those countries, and the eligibility of our Russian and Belarusian distributors to participate in public contracts.
Currently, a fairly concentrated number of distributors contribute a meaningful
f
minority of our product revenue and we may have little
recourse, short of termination, in the event that a distributor fails to execute according to our expectations and contractua
t
l provisions. In
the past, we have experienced weaker than expected growth due to declining performance by certain of our distributors. Periodically,
we transition certain territories to new distribution partners or our direct sales for
f
ce where we believe we can improve performance
relative to the distributor. Because new distribution partners or our direct sales for
f
ce may have limited experience marketing and selling
our products in certain territories, or at all, we cannot be certain that they will perform better than the predecessor distributor. In certain
cases, our distributors hold the regulatory a
r
ppr
a
oval to sell INTERCEPT for their particular geography. Termination, loss of exclusivity
or transitioning from these distributors may require us to negotiate a transfer of the applicable regulatory a
r
ppr
a
ovals to us or new
distributors which may be diffi
f cult to do in a timely manner, or at all. We expect that our product revenue will be adversely impacted
with the loss or transition of one or more of these distributors. If we choose to terminate distributor agreements, we would either need
to reach agreement with, qualify,
f
train and suppl
u
y a replacement distributor or suppl
u
y and service end-user customer accounts in those
territories ourselves. Although our distribution agreements generally provide that the distributor will promptly and effic
f iently transfer
f
its existing customer agreements to us, there can be no assurance that this will happe
a
n in a timely manner or at all or that the distributor
will honor its outstanding commitments to us. In addition, terminated distributors may own illuminators placed at customer sites and
may necessitate us to repurchase those devices or require end-user customers to purchase new devices from us. Additionally, we may
need terminated distributors to cooperate with us or a new distributor in transitioning sub-
u
distributor relationships and contracts, hospital
contracts, public tenders, or regulatory certificates or licenses held in their name. These factors may be disrupt
r
ive for
f
our customers and
our reputation may be damaged as a result. In certain territories there may not be an alternate distributor capa
a
bl
a e of covering the entirety
of the geography, in which case we may need to contract and manage multiple distributors for
f
a region or a distributor and sub-distributor
system. Such complexities will dilute our attention and may result in customer dissatisfaction. Our distribution partners may have more
establ
a ished relationships with potential end user customers than a new distributor or we may have in a particular territory, which could
adversely impact our ability to successful
f ly commercialize our products in these territories. In addition, it may take longer for
f
us to be
paid if payment timing and terms in these new arrangements are less favorable to us than those in our existing distributor arrangements.
As we service end-user accounts directly rather than through distributors, we incur additional expense, our working capital is negatively
impacted due
d
to longer periods from cash collection fro
f
m direct sales customers when compared to the timing of cash collection fro
f
m
our former distribution partners and we may be exposed to additional complexity including local statutory and tax compliance. Current
or transitioning distributors may irreparabl
a y harm relationships with local existing and prospective customers and our standing with the
blood banking community in general. In the event that we are unabl
a e to fin
f d alternative distributors or mobilize our own sales effo
f
rts in
the territories in which a particular distributor operates, customer suppl
u
y, our reputation and our operating results may be adversely
affe
f cted. In addition, in territories where new distributors are responsible for servicing end-user accounts, there will be a period of
transition in order to properly qualify a
f
nd train these new distributors, which may disrupt
r
the operations of our customers and adversely
impact our reputation and operating results. In certain cases where a terminated distributor holds title to illuminators placed in the fie
f ld,
we may choose to buy back the illuminators fro
f
m the distributor to ensure continuity of service to those customers. If this were to occur,
our recognizabl
a e product revenue would be negatively impacted.

46
In Februa
r
ry 2021, we entered into an Equity Joint Venture Contract with Shandong Zhongbaokang Medical Implements Co., Ltd., or
ZBK, to establ
a ish Cerus
r
Zhongbaokang (Shandong) Biomedical Co., LTD., or the JV, for
f
the purpos
r
e of developing, obtaining
regulatory a
r
ppr
a
oval for
f
, and eventual manufac
f
turing and commercialization of the INTERCEPT blood system for platelets and red blood
cells in the People’s Republic of China. We own 51% of equity in the JV and consolidate the JV. The JV will need to obtain regulatory
r
approval for
f
the INTERCEPT Blood System for Platelets and Red Blood Cells before it can begin commercializing in China. In order
to obtain that regulatory a
r
ppr
a
oval, the JV may need to run additional clinical studi
t
es in China. We cannot assure you the JV will be
successful
f
in meeting the endpoint, once defin
f ed, or be successful in meeting any other requirements or that it will ever receive regulatory
r
approval. Furthermore, the JV will need to demonstrate compliance with cybersecurity regulations to obtain appr
a
oval of the illuminator
in China. The current illuminator was not designed with current cybersecurity standards and safeguards. Should the JV be unsuccessful
in demonstrating compliance with the contemporary c
r
ybersecurity requirements, the abi
a lity to obtain appr
a
oval for
f
INTERCEPT platelets
in China may also be impaired. If the JV is unabl
a e to obtain regulatory a
r
ppr
a
oval to sell INTERCEPT in China, our ability to grow our
business and achieve significant revenues in China will be negatively impacted. We may be unabl
a e to realize a retur
t
n on any investment
in the JV or we may not be able to monetize any profit
f
or otherwise generate meaningful
f
value fro
f
m our ownership of the JV.
Our manufac
f
turing
i
supp
u
ly chain e
i
xpos
e
es us to sign
i
ific
f ant risks.
We do not own our own manufac
f
turing facilities, but rather manufact
f
ur
t
e our products using a number of third-party suppl
u
iers, many of
whom are our sole suppl
u
iers for the particular product or component that we procure. We rely on various contracts and our relationships
with these suppliers to ensure that the sourced products are manufact
f
ur
t
ed in sufficient quantities, timely, to our exact specifications and
at prices we agree upon
u
with the supplier. For example, Fresenius is our sole suppl
u
ier for
f
the manufact
f
ur
t
e of fin
f ished disposable kits for
the platelet and plasma systems. We also rely on other third-party suppl
u
iers for other components and products that are currently our
sole qualifie
f d suppliers for such components and products. In the event Fresenius or any of our other sole qualifie
f d suppliers refuses or
is unabl
a e to continue operating under our suppl
u
y agreements with them, we may be unabl
a e to maintain inventory l
r
evels or otherwise
meet customer demand, and our business and operating results would be materially and adversely affected. Fresenius may have fin
f ancial
constraints or impose additional fin
f ancial conditions on us. We may also encounter unfor
f
eseen manufac
f
turing difficulties which, at a
minimum, may lead to higher than anticipated costs, scrap r
a
ates, or delays in manufact
f
ur
t
ing products. In addition, our produc
d
t supply
chain requires us to purchase certain components in minimum quantities or make last time purchases of obsolete components and may
result in a production cycle of more than one year. Significant disrupt
r
ions to any of the steps in our suppl
u
y chain process may result in
longer productions cycles which could lead to ineffi
f cient use of cash or may impair our ability to suppl
u
y customers with produc
d
t.
Moreover, the price that we pay to some of our suppl
u
iers is dependent on the volume of products or components that we order. If we are
unabl
a e to meet the volume tiers that afford the most fav
f
orable pricing, our gross margins will be negatively impacted.
Facilities at which the INTERCEPT Blood System or its components are manufact
f
ur
t
ed may cease operations for planned or unplanned
reasons or may unilaterally change the formulations of certain commercially availabl
a e reagents that we use, causing at least temporary
interrupt
u ions in suppl
u
y. Certain equipment used by manufac
f
turing partners are only used to manufact
f
ur
t
e our products and are
significantly aged and maintained by a limited number of vendors. Should our partners be unabl
a e to service and maintain this equipment,
production volume and quality of our products may be limited. Furthermore, suppl
u
iers producing third-party components which are used
by our customers and are compatible for use in combination with our products may not be availabl
a e for
f
a variety of reasons, including
manufac
f
turing problems, regulatory delays or audit defic
f iencies. Should that happen, customers may not be able to use our produc
d
t with
alternate components for
f
which our products are compatible, which in turn, may damage our business. In addition, we may need to
identify, validate and qualify additional manufact
f
ur
t
ing capacity with existing or new suppl
u
iers. Further, customer demand for
f
our platelet
kits is likely to fully utilize the production capa
a
city of our third-party manufact
f
ur
t
er(s). Under the terms of our 2022 Agreement, Fresenius
will expand manufact
f
ur
t
ing of the components and disposable sets to multiple production faci
f
lities, following qualification and licensure
of such additional faci
f
lities. If Fresenius experiences any delays in the qualific
f ation and licensure for its new production facilities, then
our ability to continue to grow the platelet business will be impaired and our suppl
u
y and mix of platelet kits or plasma kits will be
adversely impacted. Even a temporary f
r
ai
f lure to suppl
u
y adequate numbers of INTERCEPT Blood System components may cause an
irreparabl
a e loss of customer goodwill and potentially irreversible loss of momentum
t
in the marketplace. Although we are actively
evaluating alternate suppl
u
iers and have made and plan to continue making capital investments to operationalize additional sites within
our existing suppl
u
ier’s networks for certain components and finished kits, we do not have qualifie
f d additional sites or suppliers or
capacity beyond those on which we currently rely, and we understand that Fresenius relies substantially on sole suppl
u
iers of certain
materials for
f
our products. In addition, suppl
u
iers from whom our contract manufac
f
turers source components and raw materials may
cease production or supply of those components to our contract manufact
f
ur
t
ers. Identific
f ation and qualific
f ation of alternate suppl
u
iers is
time consuming and costly, and there can be no assurance that we will be able to demonstrate equivalency of alternate components or
suppl
u
iers or that we will receive regulatory approval in the U.S. or other jurisdictions. If we conclude that suppl
u
y of the INTERCEPT
Blood System or components fro
f
m suppliers is uncertain, we may choose to build and maintain inventories of raw materials, work-in-
process components, or finished goods, which would consume capital resources faster than we anticipate and may cause our suppl
u
y
chain to be less effic
f ient.
We have purchased a last time build of our current model illuminator due to obsolescence of certain components. As a result, we will
not be able to continue manufac
f
turing the current model illuminator. We are currently developing the new illuminator which may take
an extended period of time to complete and obtain regulatory a
r
ppr
a
oval. Until such time as we obtain appr
a
oval for
f
the new LED-based

47
illuminator, if ever, the demand for
f
illuminators may be higher than the remaining number of illuminators in inventory,
r
resulting in
possible customer allocations or loss of sales. We may seek to obtain regulatory a
r
ppr
a
oval in certain geographies with the current model
illuminator prior to the new model illuminator becoming availabl
a e. Should regulators require cybersecurity safeguards of the current
model illuminator, we may be unabl
a e to satisfy such requirements. We anticipate that we will need to continue investing in subsequent
versions of the illuminator to enhance func
f
tionality and manage obsolescence. We and our customers rely on the availabi
a lity of spare
parts and replacement components to ensure that customer platelet and plasma production is not interrupt
u ed. If we are not able to suppl
u
y
spare parts or replace components dur
d
ing the maintenance of customer illuminators, our ability to keep existing customers, increase
production for
f
existing customers or sign up new customers may be negatively impacted. We understand that components used in the
currently approved illuminator design are no longer commercially availabl
a e beyond what we have stockpiled or to which we have access
under fin
f al buy transactions or may become unavailabl
a e in the current specifications in the near-term. As components become
unavailable or obsolete, we may be required to identify a
f
nd qualify r
f
eplacement components for
f
the current model illuminator and in
doing so, we may be required to conduct additional studies, which could include clinical trials to demonstrate equivalency or validate
any required design or component changes. In addition, our illuminators contain embedded proprietary software that runs on software
code we have developed and that we own. Changes to certain components due
d
to obsolescence, illuminator redesign or market demand,
may require us to modify the existing softw
f
are code or to develop new illuminator softw
f
are. Our abi
a lity to develop new illuminator
software, correct coding flaws and generally maintain the softw
f
are code is reliant on third-party contractors who, in some cases, have
sole knowledge of the softw
f
are code. Our ability to develop and maintain the illuminator software may be impaired if we are not able
to continue contracting with those key third-party contracted developers or if we are unabl
a e to source alternate employees or consultants
to do so.
We have signed an agreement with a supplier to produce the new LED-based illuminator. Some of the new components require long
order lead times and have required that we procure the components in advance of receiving regulatory a
r
ppr
a
oval in order to satisfy
demand for our products. While we have validated this new suppl
u
ier for
f
the new LED-based illuminator, until we obtain regulatory
r
approvals and sell those, sales of illuminators will be limited to the quantity of the current model illuminator that we have on hand.
Furthermore, our ability to maintain the existing installed base of current model of illuminators is limited, in some cases, to the existing
stockpiled components that we have on hand and our ability to calibrate light dose on such illuminators is limited to maintaining the
bulbs required to operate a calibration station and external radiometers. Any failure to, or delays in, receiving regulatory a
r
ppr
a
ovals for
the redesigned illuminator, or increased costs associated with mitigating any such delays, could materially and adversely affect our
business, financial condition, results of operations and growth prospects and impair our sales and ability to penetrate new markets. Our
inability to effi
f ciently and timely convert the existing illuminators in the field to the new illuminator, if appr
a
oved, could negatively
impact our ability to maintain the existing installed base.
In order to increase and diversify m
f
anufact
f
ur
t
ing capacity, our manufact
f
ur
t
ing partners have in the past, and may in the future, require us
to pay for
f
capi
a tal investments in whole or in-part in order to offset the impact of cash flows and risk. To meet the growing demand for
f
our products and to invest in future quality improvements and gross margin expansion, we have invested in capital equipment, capacity
expansion and cost reduction proje
o cts with many of our suppl
u
iers. These projects may cost more than anticipated, may not produc
d
e the
anticipated benefits or may be delayed, any of which would potentially limit our expected return on investment and affect our operations.
In the event that alternate manufact
f
ur
t
ers or alternate manufact
f
ur
t
ing sites are identifie
f d and qualifie
f d, we will need to transfer
f
know-how
relevant to the manufac
f
ture of the INTERCEPT Blood System to such alternate manufact
f
ur
t
ers and manufac
f
turing sites; however, certain
of our suppl
u
ier’s materials, manufact
f
ur
t
ing processes and methods are proprietary to them, which will impair our ability to establish
alternate sources of supply, even if we are required to do so as a condition of regulatory a
r
ppr
a
oval. We may be unabl
a e to establish alternate
suppl
u
iers without having to redesign certain elements of the platelet and plasma systems. Such redesign may be costly, time consuming
and require further regulatory r
r
eview and approvals. We may be unabl
a e to identify,
f
select, and qualify s
f
uch manufact
f
ur
t
ers or those third
parties abl
a e to provide suppor
u
t for
f
development and testing activities on a timely basis or enter into contracts with them on reasonabl
a e
terms, if at all. Furthermore, in order to gain access to certain markets, local or regional manufact
f
ur
t
ing may be required for certain
production aspects of our products. Such requirements will require additional oversight from a quality and suppl
u
y chain perspective and
will potentially dilute any economies of scale we would have otherwise been able to generate from existing supplier sites.
Moreover, the inclusion of components manufac
f
tured by new suppl
u
iers or by alternate sites within our current network of suppliers
could require us to seek new or upda
u
ted app
a
rovals from regulatory a
r
uthorities, which could result in delays in product delivery.
r
We may
not receive any such required regulatory a
r
pp
a
rovals. We cannot assure you that any amendments to existing manufact
f
ur
t
ing agreements
or any new manufact
f
ur
t
ing agreements that we may enter into will contain terms more favorable to us than those that we currently have
with our manufactur
t
ers. Many of the existing agreements we have with suppl
u
iers contain provisions that we have been operating under
for an extended period of time, including pricing. Should we enter into agreements or amend agreements with any manufac
f
turer with
less favorable terms, including pricing, our results of operations may be impacted, our recourse against such manufactur
t
ers may be
limited, and the quality of our products may be impacted. Furthermore, we do not have experience working with partners that are
producing our products in multiple sites globally. Should we need to oversee our manufac
f
turers producing components or fin
f ished goods
for our products in multiple global plants, we may be unsuccessful
f
in providing an adequate level of oversight, may be unabl
a e to manage
the complexity of such operations, including quality, incur additional costs in managing the global supply chain including capital
investments in those plants or become less efficient with our use of cash and working capital.

48
Raw materials, components or fin
f ished product may not meet specifications or may be subject to other non-confor
f
mities. In the past,
non-confor
f
mities in certain component lots have caused delays in manufac
f
turing of INTERCEPT disposable kits. Similarly, we have
experienced non-conformities and out of specific
f ation results in certain component manufac
f
turing needed for clinical use, commercial
sale and regulatory s
r
ubmissions. Non-confor
f
mities can increase our expenses and reduc
d
e gross margins or result in delayed regulatory
r
subm
u
issions or clinical trials. Any quality failure in manufact
f
ur
t
ing by our suppl
u
iers may result in a significant write down and impact
to our reported gross margins. Should non-confor
f
mities occur in the future, we may be unabl
a e to manufact
f
ur
t
e products to suppor
u
t our
red blood cell clinical trials, or to meet customer demand for our commercial products, which would result in delays for
f
our clinical
programs, or lost sales for
f
our commercial products, and could cause irreparabl
a e damage to our customer relationships. Later discovery
of problems with a product, manufac
f
turer or fac
f
ility may result in additional restrictions on the product, manufact
f
ur
t
er or facility,
including withdrawal of the product fro
f
m the market.
In addition, we may not receive timely or accurate demand information fro
f
m distributors or direct customers, or may not accurately
forecast demand ourselves for the INTERCEPT Blood System. Should actua
t
l demand for
f
our products exceed our own for
f
ecasts or
forecasts that customers provide, we may be unabl
a e to ful
f fill such orders timely, if at all. Should we be unabl
a e to ful
f fill demand, our
reputation and business prospects may be impaired.
Further, certain distributors and customers require, and potential fut
f ur
t
e distributors or customers may require, product with a minimum
shelf life.
f
If customers requiring minimum shelf-lives order smaller quantities or do not purchase product as we anticipate, or at all, we
may have elevated inventory l
r
evels with relatively short shelf-l
f ives which may lead to increased write-offs and inefficient use of our
cash. Should we choose not to fulfil
f l smaller orders with minimum shelf lives, our product sales may be harmed. We will need to destroy
or consume outdated inventory i
r
n product demonstration activities, which may in turn lead to elevated product demonstration costs
and/or reduced gross margins. In order to meet minimum shelf-l
f ife r
f
equirements, we may need to manufact
f
ur
t
e suffi
f cient product to
meet estimated for
f
ecasted demand. As a result, we may carry excess work-in-process or fin
f ished goods inventory,
r
which would consume
capital resources and may become obsolete, or our inventory m
r
ay be inadequate to meet customer demand. Our platelet and plasma
systems’ disposable kits have 18 to 24 months shelf lives from the date of manufact
f
ur
t
e. Should we change or modify any of our product
config
f urations or components, such future config
f urations of our products may not achieve the same shelf life t
f
hat existing products
have. Given the logistical challenges of producing the products in Europe before shipping to the U.S., we may incur elevated air fre
f ight
costs, may receive requests by customers to retur
t
n expired product or we may not be able to suppl
u
y product to customers in the U.S.
timely. In addition, our suppl
u
y chain has been impacted by worker strikes and other disrupt
u ions at ports in which we ship product fro
f
m
and into. Should we encounter such disrupt
r
ions in the fut
f ur
t
e, we may choose to incur air-freight costs which are much more expensive
than ocean shipment and often result in more damage to our produc
d
ts than ocean shipment. We and our distributors may be unabl
a e to
ship product to customers prior to the expiration of the produc
d
t shelf life,
f
a risk that is heightened if we elect to increase our inventory
r
levels in order to mitigate supply disrupt
u ions. We have entered into certain public tenders or may enter into commercial contracts with
customers, that call for us to maintain certain minimum levels of inventory.
r
If our suppl
u
iers fail to produce components or our finished
products satisfactorily, timely, at acceptabl
a e costs, and in suffic
f ient quantities, we may incur delays, shortfal
f ls and additional expenses,
or non-compliance with certain public tenders which may in turn result in penalty fees
f
, permanent harm to our customer relations or
loss of customers. In addition, certain large national prospective customers, like those in the UK or Japa
a
n, may choose to convert all of
their operations to INTERCEPT. Should we or our suppl
u
iers encounter any manufact
f
ur
t
ing issues or if we and our suppl
u
iers are not able
to build more manufact
f
ur
t
ing capacity, we may not be able to satisfy all of the global demand or may have to allocate available product
to certain customers which may for
f
ce customers to adopt competing products, which could permanently impact our ability to convert
those customers to INTERCEPT users and may negatively impact our customers operations and consequently, our competitive position
and reputation. Conversely, we may choose to overstock inventory i
r
n order to mitigate any unfor
f
eseen potential disrupt
u ion to
manufac
f
turing which could consume our cash resources faster than we anticipate and may cause our suppl
u
y chain to be less effi
f cient.
The current conflic
f
t in the Middle East and impact on shipping routes may result in increased costs to ship our products via ocean and
meet our suppl
u
y chain requirements. Should the conflic
f
t continue or worsen, or if it begins to impact our costs or abi
a lity to secure
shipping, or if we are unabl
a e to ship products and components to meet our suppl
u
y chain demand, we may encounter delays, and/or have
to rely on air fre
f ight which is significantly more expensive than ocean shipment.
Until we sell sufficient INTERCEPT Blood System for Cryoprecipitation kits to blood center affi
f liate organizations or expand the
number of manufac
f
turing partners producing IFC for us, our IFC sales will be limited. Additionally, because IFC are produc
d
ts derived
from our INTERCEPT Blood System for plasma, any supply disrupt
u ions or failures that could impact our plasma system will have a
negative direct impact on the production of IFC. The pricing for
f
plasma derived products has become increasingly competitive and has
placed a strain on the availabi
a lity of plasma for production of IFC. Should this constraint escalate or be prolonged, our costs may
increase, or we may be unabl
a e to meet the demand we and others have generated for
f
IFC. Should that occur, the dependabi
a lity of a
consistent suppl
u
y may be called into question and customers and prospective customers may choose not to use IFC for their operations.
To minimize this risk, we may meet hospital or blood center demand and choose to purchase IFC from blood centers outside of our
current manufactur
t
ing partners which may not be economical. We currently have limited experience with customer expectations
regarding tur
t
nover or inventory l
r
evels of IFC held at either our blood center manufac
f
turing partners or at the hospitals themselves. Our
IFC product has a shelf life o
f
f fiv
f e days fro
f
m thaw befor
f
e it expires. To mitigate product expiration, should hospitals require that we
use a consigned inventory m
r
odel whereby unused produc
d
t at the hospital at expiration is replaced with fresh product at reduc
d
ed or no

49
cost to the hospital, we may need to keep additional inventory o
r
r manufact
f
ur
t
e IFC above levels generating an economic return, which
could adversely affe
f ct our results of operations and fin
f ancial condition.
Obsolescence or shortage
a
of raw mater
t
ials, k
s
ey components of and accessories to the INT
I
ERCEP
T
T Blood System
t
, may impac
m
t our
abili
i ty
i
to suppl
u
y o
l
ur custom
t
ers,
r
may n
a
egativ
t ely i
l
mp
i
act the
t
operational costs of our customers and may increase the prices at which
we sell our products,
t
resultin
t
g in s
i
lower tha
t
n antic
t ipated
t
growth or negat
e
iv
t e fut
f
ure fin
f
ancial perfor
f
ma
r
nce.
The manufact
f
ur
t
e, suppl
u
y and availabi
a lity of key components of, and accessories to, our products are dependent upon a limited number
of third parties and the commercial adoption and success of our products is dependent upon the continued availability of these
components or accessories. For example, our customers rely on continued availabi
a lity of third-party sets, suppl
u
ied plastics, saline and
reagents for processing, storing and manufac
f
turing blood components. If the blood product industry e
r
xperiences shortages of these
components or accessories, or if manufac
f
turers cease production of these components or accessories, the availabi
a lity and use of our
products may be impaired.
With respect to the manufact
f
ur
t
e of our products, our third-party manufact
f
ur
t
ers source components and raw materials for the manufact
f
ur
t
e
of the INTERCEPT processing sets. Certain of these components are no longer commercially availabl
a e, are nearing end-of-l
f ife o
f
r are
availabl
a e only fro
f
m a limited number of suppliers. We and our third-party manufac
f
turers do not have guaranteed suppl
u
y contracts with
all of the raw material or component suppl
u
iers for our products, which magnify the risk of shortage and obsolescence and decreases our
manufac
f
turers’ abi
a lity to negotiate pricing with their suppliers. For example, a solvent used in the manufact
f
ur
t
e of the plastic beads for
f
the compound adsorption devices used for our products is no longer availabl
a e. Accordingly, we purchased all remaining existing
material. We will need to qualify plastic beads produced with a new solvent prior to consuming availabl
a e inventory l
r
evels. If we are
unabl
a e to use all of the raw material produced during the final production run,
r
or if the fin
f al material produces subopt
u
imal results, we
may require customers to modify their operating practices, or run
r
out of material before an alternate material can be qualifie
f d. Moreover,
we may be required to impair or write-off the value of any unused last-time-buy raw materials or components. Customers may object to
changes in operating practices or changes to the instructions for use, and a potential negative impact on their operations as a result of
the use of this material, could impair our reputation or customer acceptance of our products. Changes in environmental, safety or other
regulations may require change to our products which would result in increased distraction of personnel and increased cost. For instance,
certain plasticizers may be phased out. Should that occur, fin
f ding, validating and demonstrating comparabi
a lity of an alternative may be
time consuming and costly, if feas
f
ible at all. Any shortage, obsolescence or discontinuation of raw materials, components or accessories
or our inability to control costs associated with raw materials, components or accessories, could increase our costs to manufac
f
ture our
products or increase our costs to supply our customers. Further, if any supplier to our third-party manufact
f
ur
t
ers is unwilling or unabl
a e
to provide high quality raw materials in required quantities and at acceptabl
a e prices, our manufact
f
ur
t
ers may be unabl
a e to fin
f d alternative
sources or may fai
f l to fin
f d alternative suppliers at commercially acceptabl
a e prices, on satisfactory t
r
erms, in a timely manner, or at all.
Furthermore, we do not yet know whether or not certain components or accessories used by blood center operators or used in the
production of INTERCEPT will comply with the new standards under the MDR. Failure to comply with the new standards timely may
result in a disrupt
u ion to blood center operations or the manufact
f
ur
t
e of the INTERCEPT Blood System. If any of these events were to
occur, our product quality, competitive position, reputation and business could suffe
f r, we could experience cancellations of customer
orders, refus
f
al by customers to accept deliveries or a reduction in our prices and margins to the detriment of our financial performance
and results of operations.
Risks Related to Our Financial Condition and Capital Requirements
We expe
x
ct to contin
t
ue to generate losses and we may never achieve a profi
o ta
i ble l
l
evel
l
of operations.
Our cost of product sold, research and development and selling, general and administrative expenses have resulted in substantial losses
since our inception. While our net losses have recently narrowed, at our expected and guided sales levels of the platelet, plasma and
cryopr
r
ecipitation systems, and of IFC, our costs to manufac
f
ture, distribute, market, and sell our products, support the systems and
develop new products may be in excess of our revenue. In particular, it is expensive and time consuming to continually address ever-
changing regulatory r
r
equirements whether those changes are due
d
to changes in the requirements or changes in our produc
d
ts to expand
or maintain our products’ label claims. Furthermore, the cost of complying with increased oversight and changing requirements under
U.S. GAAP, the SEC and PCAOB and other administrative regulators may be unsustainable or increase faster than the anticipated
revenue growth. In addition, we expect to incur additional research and development costs associated with inflationary pressures on
labor
a
and study costs, the development of diffe
f rent config
f urations of existing product candidates and products and our illuminator,
development of new products, planning, enrolling and completing ongoing clinical and non-clinical studi
t
es, including the post-approval
studi
t
es or registry stud
t
ies we are and may be required to conduct in connection with the appr
a
ovals of the platelet system, pursuing
potential regulatory a
r
pp
a
rovals in other geographies where we do not currently sell our platelet and plasma systems, planning and
conducting in vitro studi
t
es and clinical development of our red blood cell system in Europe and the U.S., performing the agreed-upon
activities under our government agreements, legal compliance, and creating, maintaining and defending our intellectua
t
l property.
Moreover, both our near and long-term capi
a tal requirements will require that we continue to invest in capi
a tal purchases to suppor
u
t
ongoing and proposed studi
t
es, in addition to manufac
f
turing capacity expansion to support our growing business. In addition, we may
need to obtain additional funds
f
to complete development activities for
f
the red blood cell system necessary for CE Certificates of
Confor
f
mity in the EU, if costs are higher than anticipated or we encounter further delays. In this regard, our product development costs

50
will be ongoing in connection with our failure to obtain appr
a
oval of our MDR appl
a
ication and the potential subm
u
ission of a new MDR
application and would also increase if existing clinical data is insufficient for
f
us to either subm
u
it or potentially obtain appr
a
oval of any
such new appl
a
ication. We may need to obtain additional fundi
f
ng to conduct additional randomized controlled clinical trials for existing
or new products, particularly if we are unabl
a e to access any additional portions of the fundi
f
ng contemplated by our government contracts,
and we may choose to defer
f
such activities until we can obtain suffi
f cient additional fundi
f
ng or, at such time, our existing operations
provide sufficient cash flo
f w to conduct these trials. These costs could be substantial and could extend the period during which we expect
to operate at a loss, particularly if we experience any diffi
f culties or delays in completing the activities. In addition, we may be required
to reduce the sales price for our products in order to make our products economically attractive to our customers and to governmental
and private payors, or to compete fav
f
orably with other blood safety interventions or other pathogen reduc
d
tion technologies, which may
reduce or altogether eliminate any gross profit on sales.
If we fail to obtai
t n t
i
he
t
capi
a ta
i l necessary to fund our fut
f
ure ope
o
rations or if we are unable t
l
o g
t
enerate s
t
uffi
f cient positiv
t e cash flo
f ws
from our ope
o
rations, w
s
e will need to curtai
t l p
i
lanned developm
o
ent or sales
l
and commercializatio
t n activ
t ities.
While we have recently been able to generate a suffi
f cient amount of revenue and generate positive net cash flo
f ws from operations, we
may be unabl
a e to sustain those results in the fut
f ur
t
e. If we are unabl
a e to continue to produce positive operating cash flo
f ws or at sufficient
levels, meeting our long-term capital requirements will be, in large part, reliant on continued access to funds
f
under our government
contracts and the public and private equity and debt capital markets, as well as on collabor
a
ative arrangements with partners, augmented
by cash generated from operations, if at all, and interest income earned on the investment of our cash balances. While we believe that
our availabl
a e cash and cash equivalents and short-term investments, as well as cash received fro
f
m product sales and under our agreements
with BARDA, the FDA, and the DoD, will be sufficient to meet our capital requirements for
f
at least the next 12 months, if we are unable
to generate sufficient product revenue, or access suffi
f cient fun
f
ds under our government contracts or the public and private equity and
debt capital markets, we may be unabl
a e to execute successful
f ly on our operating plan. We have based our cash suffi
f ciency estimate on
assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, including inflationary assumptions, we could
consume our availabl
a e capital resources sooner than we currently expect or in excess of amounts than we currently expect, which could
adversely affect our commercialization and clinical development activities. In addition, while our stated goal is to achieve profit
f ability
in the fut
f ur
t
e, actual results may be diffe
f rent than our forecasted operating plan and may require that we make certain trade-offs
f
to
potentially achieve profit
f ability. Such trade-offs
f
may negatively impact our commercial potential or result in defer
f rals in development
activities.
We have borrowed and in the fut
f ur
t
e may borrow additional capital fro
f
m institutional and commercial banking sources to fund fut
f ur
t
e
growth, including pursuant to our Amended and Restated Credit, Security and Guaranty Agreement (Term Loan), or the Term Loan
Credit Agreement, and our Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan), or the Revolving Loan
Credit Agreement, both with MidCap Financial Trust, or MidCap,
a
or potentially pursuant to new arrangements with differ
f ent lenders.
We have borrowed and may in fut
f ur
t
e borrow funds
f
on terms that may include restrictive covenants, including covenants that restrict the
operation of our business, liens on assets, high effective interest rates, fin
f ancial performance covenants and repayment provisions that
reduce cash resources and limit future access to capital markets. In addition, unless we restruc
r
ture our credit agreements prior to April
1, 2026, or qualify f
f
or
f
and exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term
Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due
d
in cash, which
would negatively impact our availabl
a e working capital beyond the next 12 months. Should interest rates increase, the rates that we are
obligated to pay under our credit agreements would increase, leading to higher interest expense. In addition, we expect to continue to
opportunistically seek access to the equity capital markets to suppor
u
t our development efforts and operations. To the extent that we raise
additional capital by issuing equity securities, our stockholders may experience subs
u
tantial dilution. To the extent that we raise additional
funds through collabor
a
ation or partnering arrangements, we may be required to relinquish some of our rights to our technologies or
rights to market and sell our produc
d
ts in certain geographi
a
es, grant licenses on terms that are not favorable to us, or issue equity that
may be substantially dilutive to our stockholders. Moreover, recent developments in the fin
f ancial services industry c
r
ould cause us to
experience liquidity constraints or fai
f lures, hinder our ability to perform obligations under various types of fin
f ancial, credit or liquidity
agreements or arrangements, and result in fur
f
ther disrup
r
tions or instability in the fin
f ancial services industry o
r
r fin
f ancial markets. In
addition, widespread investor concerns regarding the U.S. or international fin
f ancial systems could result in less fav
f
orable commercial
financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access
to credit and liquidity sources, thereby making it more diffi
f cult for us to acquire financing on acceptabl
a e terms or at all. Any decline in
availabl
a e fundi
f
ng or access to our cash and liquidity resources could, among other risks, adversely impact our ability to meet our
operating expenses, fin
f ancial obligations or fulfill
f
our other obligations, result in breaches of our financial and/or contractua
t
l obligations
or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting fro
f
m the factors
described above
a
or other related or similar factors not described above
a
, could have material adverse impacts on our liquidity and our
current and/or projected business operations and fin
f ancial condition and results of operations.
As a result of economic conditions, general global economic uncertainty, political change, war, the effe
f cts of infla
f tionary pressures,
including those resulting from new tariffs and escalating trade tensions, and other fac
f
tors including past and potential fut
f ur
t
e U.S. bank
failures, we do not know whether additional capital will be availabl
a e when needed, or that, if availabl
a e, whether we will be able to obtain
additional capital on reasonabl
a e terms. Specifically, monetary policies of many countries, as well as recent bank fai
f lures, have

51
significantly disrupt
r
ed global fin
f ancial markets, and may limit our ability to access capital, which could in the future negatively affect
our liquidity. As a result of stimulus programs put in place over the past two years, the U.S. and many countries are currently
experiencing an inflationary environment. In addition, the U.S. Federal Reserve has raised, and may again raise, interest rates, in
response to concerns about inflation. Moreover, the U.S. Federal Reserve may not lower interest rates as quickly as markets expect, if
at all, which in tur
t
n could negatively impact equity values, including the value of our common stock. Furthermore, our vendors and
suppl
u
iers may raise prices in an inflationary environment, costs to transport our products may increase and access to timely shipping
may be limited. We may not be able to offs
f et price increases from vendors with price increases to customers at suffi
f cient levels, if at all,
which would harm our results of operations. If we are unabl
a e to raise additional capital due
d
to the volatile global fin
f ancial markets,
general economic uncertainty or other fact
f
ors, we may need to curtail planned development or commercialization activities. In addition,
we may need to obtain additional funds
f
to complete development activities for
f
the red blood cell system necessary for CE Certificates
of Confor
f
mity in the EU, if costs are higher than anticipated or we encounter further delays. In this regard, our product development
costs not reimbursed by our BARDA agreements will be prolonged in connection with our failure to obtain appr
a
oval of our MDR
application and the potential subm
u
ission of a new MDR appl
a
ication. Development costs not covered by our BARDA agreements may
increase if existing clinical data is insufficient for
f
us to either subm
u
it or potentially obtain appr
a
oval of any such new appl
a
ication. We
may need to obtain additional fundi
f
ng to conduct additional randomized controlled clinical trials for existing or new produc
d
ts,
particularly if we are unabl
a e to access any additional portions of the fundi
f
ng contemplated by our government contracts, and we may
choose to defer
f
such activities until we can obtain suffi
f cient additional fundi
f
ng or, at such time, our existing operations provide suffi
f cient
cash flo
f w to conduct these trials.
Covenants in our Ter
T
m L
r
oan Credit
d
Agreement and Revolving Loan Credit
d
Agreement can restri
t ct our business and operations in
many ways
a
and if w
i
e do n
d
ot effe
f ctiv
t ely m
l
anage our covenants, o
s
ur fina
i
ncial conditi
i ons and results of operations could be adverse
r
ly
affe
f cted
t
. I
d
n a
I
dditi
i on, our operations may n
a
ot provide s
d
uffi
f cient cash to m
t
eet the repayment oblig
l atio
t ns of our deb
d
t inc
i
urred under
d
the Ter
T
m L
r
oan Credit
d
Agreement and Revolving Loan Credit
d
Agreement.
As of December 31, 2024, our total indebtedness under our Term Loan Credit Agreement and Revolving Loan Credit Agreement was
approximately $84.2 million. All of our current and fut
f ur
t
e assets, except for
f
intellectua
t
l property and certain investments in subsidiaries
and affiliates, are secured for
f
our borrowings under the Term Loan Credit Agreement and Revolving Loan Credit Agreement. The Term
Loan Credit Agreement and Revolving Loan Credit Agreement require that we comply with certain covenants appl
a
icable to us and our
subs
u
idiary, including among other things, covenants restricting dispositions, changes in business, management, ownership or business
locations, mergers or acquisitions, indebtedness, encumbrances, distributions, investments, transactions with affi
f liates and subordinated
debt, any of which could restrict our business and operations, particularly our ability to respond to changes in our business or to take
specified actions to take advantage of certain business opportunities that may be presented to us. Our fai
f lure to comply with any of the
covenants could result in a default under the Term Loan Credit Agreement or the Revolving Loan Credit Agreement, which could permit
the lenders to declare all or part of any outstanding borrowings to be immediately due and payable, or to refus
f
e to permit additional
borrowings under the Term Loan Credit Agreement or the Revolving Loan Credit Agreement. In addition, our failure to comply with
certain financial covenants could result in the lenders obtaining a security interest in our intellectua
t
l property. If we are unabl
a e to repay
those amounts, the lenders under the Term Loan Credit Agreement or the Revolving Loan Credit Agreement could proceed against the
collateral granted to them to secure that debt, which would seriously harm our business. In addition, should we be unabl
a e to comply
with these or certain other covenants or if we default on any portion of our outstanding borrowings, the lenders can also impose an exit
fee of a percentage of the amount borrowed pursuant to the Term Loan Credit Agreement. Unless we prepay the principal amount due
or meet the requirements for
f
and choose to extend the interest only period of the Term Loan we will be required to make principal
payments beginning in April 2026 until March 1, 2028 if not repaid sooner.
Risks Related to Managing Our Growth and Other Business Risks
We operate a compl
m ex
l
global
l
commercial organ
r
izatio
t n, with
i
limited expe
e
rience in many countri
t es. We h
W
ave limit
l
ed
t
resources and
expe
x
rience complying with regu
e
latory, l
y
eg
l
al, t
l
ax
t
and politic
l
al complexi
e tie
i
s as we expan
e
d int
i
o n
t
ew and inc
i
reasingly b
l
road
geographies. We may b
a
e dis
d tracted by e
b
xpan
e
sion into new geogr
o
aphies where we do not have expe
e
rience and we may be unsuccessfu
s
l
in monetizi
i ng
i
such opportunitie
i
s for
f
the benefit
f
of our organizatio
t n at lar
l
ge
r
.e
We are responsible for worldwide sales, marketing, distribution, maintenance and regulatory s
r
upport of the INTERCEPT Blood System.
If we fail in our effo
f
rts to develop or maintain such internal competencies or establ
a ish acceptabl
a e relationships with third parties to
suppor
u
t us in these areas on a timely basis, our ability to commercialize the INTERCEPT Blood System may be irreparabl
a y harmed.
We will need to maintain and may need to increase our competence and size in a number of func
f
tions, including sales, deployment and
product support, marketing, regulatory,
r
inventory a
r
nd logistics, customer service, credit and collections, risk management, and quality
assurance systems in order to successful
f ly suppor
u
t our commercialization activities in all of the jurisdictions we currently sell and
market, or anticipate selling and marketing, our produc
d
ts. Many of these competencies require compliance with U.S., EU, South
American, Asian and local standards and practices, including regulatory,
r
legal and tax requirements, some of which we have limited
experience. In this regard, should we obtain regulatory a
r
ppr
a
oval in an increased number of geographies, we will need to ensure that we
maintain a suffi
f cient number of personnel or develop new business processes to ensure ongoing compliance with the multitude of
regulatory r
r
equirements in those territories. Hiring, training and retaining new personnel is costly, time consuming and distracting to

52
existing employees and management. Currently, we, third-party suppliers and vendors and customers are experiencing an extremely
tight labor
a
market exacerba
r
ting our ability to attract and retain talent. Furthermore, a significant component of our employee
compensation and retention practice involves stock-based compensation. Given the pull back in our stock price, key talent may not find
our stock-based compensation to be a compelling reason to join or stay employed at Cerus
r
. We have limited experience operating on a
global scale and we may be unsuccessful complying with the variety and complexity of laws and regulations in a timely manner, if at
all. In addition, in some cases, the cost of obtaining approval and maintaining compliance with certain regulations and laws may exceed
the product revenue that we recognize from such a territory, which would adversely affect our results of operations and could adversely
affe
f ct our financial condition. Furthermore, we may choose to seek alternative ways to sell or treat blood components with our produc
d
ts.
These may include new business models, which may include selling kits to blood centers, performing inactivation ourselves, staffing
blood centers or selling services or other business model changes. We have no experience with these types of business models, or the
regulatory r
r
equirements or licenses needed to pursue such new business models. We cannot assure you that we will pursue such business
models or if we do, that we will be successful
f . For example, in early 2021, we formed a joint ventur
t
e with a Chinese entity with the
intent to develop and commercialize blood transfus
f
ion products to enhance blood safety in the People’s Republic of China. Our
involvement in the joint ventur
t
e may be a distraction for
f
our management and impair our ability to successfully and timely manage our
other operations. Additionally, the operations of the joint ventur
t
e may require future capital infusion from us and we may never see a
return from our investment in the joint ventur
t
e.
Adver
d
se
r
market and economic conditio
i
ns may e
a
xa
e
cerbate c
t
ertain risk
i
s a
k
ffe
a
ctin
t
g our busine
i
ss.
Sales of our products are dependent on purchasing decisions of and/or reimbursement from government health administration authorities,
distribution partners and other organizations. As a result of adverse conditions affe
f cting the global economy and credit and fin
f ancial
markets, disrupt
r
ions due to political instability, terrorist attacks or war, economies and currencies largely affe
f cted by declining
commodity prices, infla
f tionary pressures or otherwise, these organizations may defer
f
purchases, may be unabl
a e to satisfy their
purchasing or reimbursement obligations, or may delay payment for the INTERCEPT Blood System, and of which could adversely
affe
f ct our business, financial condition, results of operations and growth prospects.
In the past, a meaningful
f
amount of our product revenue has come fro
f
m sales to distributors for
f
the Rus
R
sian and CIS country markets,
as well as Middle Eastern markets. While we believe that all patients wanting access to INTERCEPT-treated blood components should
have access, Russia’s ongoing war against Ukraine and the elevated U.S. and EU sanctions imposed against Rus
R
sia and Belarus has
made servicing our distributors in Rus
R
sia and Belarus more diffi
f cult. Additionally, the resumption of war between Israel and Hamas,
the conflic
f
t between Israel and Hezbollah, and the risk of a larger regional conflic
f
t may affe
f ct our business. We understand that certain
of our products are now prohibited to be sold under U.S. sanctions against Rus
R
sia. While we have received a license to continue ensuring
that Russian and Belarus
r
ian patients can receive INTERCEPT products, we cannot assure you that the license will be effe
f ctive for
f
an
extended period of time, if at all. Even though we obtained the license, banking restrictions have made transacting with Russian and
Belarusian customers much more diffi
f cult. If these challenges persist or worsen, we may not be able to continue transacting with those
customers. Furthermore, because of the severe devaluation of the Russian rubl
u e in the currency markets, our products have become more
costly for the Russian market. Should the situation persist or worsen, including additional sanctions in response to the war, we may be
unabl
a e to service our Russian and Belarus
r
ian distributors. Furthermore, a larger portion of the Russian economy may be spent fig
f hting
the war against Ukraine which may have a negative impact on overall healthcare budgets. Weakness and/or instability in worldwide oil
demand and/or prices, civil, political and economic distur
t
ba
r
nces and any potential spillover effect may have a negative impact on
markets that we service.
Moreover, the new Trum
r
p administration has recently imposed tariffs on certain imports, and Canada, China and other countries have
responded with retaliatory tarifff s o
f
n certain U.S. exports. We cannot predict what effects these tariffs and potential additional tariffs
f
will
have on our business including in the context of escalating trade tensions. However, these tariffs and other trade restrictions could
increase our operating costs, reduc
d
e our gross margins or otherwise negatively impact our financial results.
Risk
i
s a
k
ssociated
t
with
i
our ope
o
rations outside o
d
f t
o
he
t
United
t
Stat
t es
t
could a
l
dverse
r
ly affe
f ct our business.
We have operations and conduct business outside the United States and we plan to expand these activities. Consequently, we are, and
will continue to be, subject to risks related to operating in for
f
eign countries, which include:
•
complying with diverse and unfam
f
iliar for
f
eign laws or regulatory r
r
equirements or unexpected changes to those laws or
requirements;
•
complying with other laws and regulatory r
r
equirements to which our business activities abr
a
oad are subj
u ect, such as the U.S.
Foreign Corrupt
u
Practices Act and anti-corrupt
u ion laws, and similar laws with a significant anti-corrupt
u ion intent in for
f
eign
countries (as discussed in greater detail above under “Risk
i
s R
k
elated to Regul
e
atory A
r
ppr
A
oval, C
l
E C
C
er
C
tific
i
ates of Confor
f
mity
and Oversight
g , a
t
nd Other Legal Compliance Mat
M ters—We a
W
re subject to fed
f
er
d
al, s
l
tate and foreign l
g
aws g
w
overning our
business practices which, if violated, c
d
ould r
l
esult in substantial penalties and harm our reput
e
ation and business” and “Risk
i
s
k
Related to Our Reliance on Thi
T rd Parties—We rely on third parties to market
r
, s
t
ell, dist
i ribute and maintain our products
and to maintain customer relationships
i
in certain countries”);

53
•
differing payor reimbursement regimes, governmental payors and price controls;
•
changes in the political or economic condition of a specific
f
country or region;
•
fluctuations in the value of foreign currency versus the U.S. dollar;
•
adverse tax consequences, including changes in appl
a
icable tax laws and regulations;
•
liabi
a lities for
f
activities of, or related to, our international operations and those of our agents, distributors and joint venture
partners;
•
tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and sanctions (including those
administered by the Offi
f ce of Foreign Assets Control of the U.S. Department of the Treasury)
r
, and other trade barriers;
•
economic weakness, including inflation, bank failures, or political or economic instability in particular economies and
markets outside the U.S.;
•
difficulties in attracting, retaining, and paying qualifie
f d personnel; and
•
cultural diffe
f rences in the conduct of business.
For example, product sales of the INTERCEPT Blood System in many countries outside of the U.S. are typically invoiced to customers
in Euros. In addition, we purchase fin
f ished INTERCEPT disposable kits for our platelet and plasma systems and incur certain operating
expenses in Euros and other for
f
eign currencies. Our exposure to for
f
eign exchange rate volatility is a direct result of our product sales,
cash collection and cash payments for
f
expenses to suppor
u
t our international operations. Significant fluctuations in the volatility of foreign
currencies relative to the U.S. dollar may materially affe
f ct our results of operations. In addition, in a period where the U.S. dollar is
strengthening/weakening as compared to Euros and other currencies we transact in, our product revenues and expenses denominated in
Euros or other foreign currencies are translated into U.S. dollars at a lower/h
r igher value than they would be in an otherwise constant
currency exchange rate environment. Currently we do not have a for
f
mal hedging program to mitigate the effe
f cts of for
f
eign currency
volatility. As our commercial operations grow globally, our operations are exposed to more currencies and as a result our exposure to
foreign exchange risk will continue to grow.
Additionally, all of the employees of our subs
u
idiary, Cerus
r
Europe B.V., are employed outside the U.S., including in France, where
labor
a
and employment laws are relatively stringent and, in many cases, grant significant job protection to certain employees, including
rights on termination of employment. In addition, one of our manufact
f
ur
t
ing partners that we are dependent on is located in France and
may have employees that are members of unions or represented by a works council as required by law. These more stringent labor
a
and
employment laws to the extent that they are appl
a
icable, coupled with the requirement to consult with the relevant unions or works’
councils, could increase our operational costs with respect to our own employees and could result in passed through operational costs
by our manufactur
t
ing partner. If the increased operational costs become significant, our business, financial condition and results of
operations could be adversely impacted, perhaps
a
materially.
Moreover, the new Trum
r
p administration has called for
f
subs
u
tantial changes to for
f
eign trade policy and has recently imposed tariffs on
certain imports. Canada, China and other countries have responded with retaliatory tariffs on certain U.S. exports. If trade restrictions
and tariffs
f
increase our operating costs in the fut
f ur
t
e, and we are not able to recapture those costs from our customers, or if such
restrictions or tariffs make it more difficult for us to compete in overseas markets, our business, financial condition and results of
operations could be adversely impacted.
If we fail to attr
t act, retain and motiv
t ate k
t
ey personnel or to retain the members of our exe
e
cutive management team, our operations
and our future growth may b
a
e adverse
r
ly affe
f cted
t
.d
We are highly dependent upon our executive management team and other critical personnel, including our specialized research and
development, regulatory a
r
nd operations personnel, many of whom have been employed with us for
f
many years and have a significant
amount of institutional knowledge about us and our products. We do not carry “key person” insurance. If one or more members of our
executive management team or other key personnel were to retire or resign, our ability to achieve development, regulatory o
r
r operational
milestones for
f
commercialization of our products could be adversely affected if we are unabl
a e to replace them with employees of
comparable knowledge and experience. In addition, we may not be able to retain or recrui
r t other qualified individuals, and our effo
f
rts
at knowledge transfer
f
could be inadequate. If knowledge transfer
f , recrui
r ting and retention effo
f
rts are inadequate, significant amounts of
internal historical knowledge and expertise could become unavailabl
a e to us. We also rely on our ability to attract, retain and motivate
skilled and highly qualifie
f d personnel in order to grow our company. Our depressed stock price negatively impacts our ability to provide
perceived valuabl
a e equity compensation to our employees, including executive management. Competition for
f
qualifie
f d personnel in the
medical device and pharmaceutical industry i
r
s very i
r
ntense. Labor shortages of qualifie
f d personnel is expected to persist for
f
the
foreseeable future and has required that we broaden our searches and change the way we operate. If we are unabl
a e to attract, retain and
motivate quality individuals, our business, financial condition, ability to perform under our BARDA agreements, or results of operations
and growth prospects could be adversely affe
f cted. Even if we are able to identify and hire qualifie
f d personnel commensurate with our
growth objectives and opportunities, the process of integrating new employees is time consuming, costly and distracting to existing

54
employees and management. Such disrupt
r
ions may have an adverse impact on our operations, our ability to service existing markets
and customers, or our ability to comply with regulations and laws.
Virt
i ually all o
l
f o
o
ur research and devel
d
opm
l
ent activ
t itie
t s and the signi
g
fi
i cant majo
a rity
i
of our general and administrativ
t e activ
t ities are
perfor
f
me
r
d in o
i
r managed fro
f
m a sing
i
le
g
site
i
that may b
a
e subje
b ct to lengthy b
h
usiness int
i
er
t
rupt
u io
t n in t
i
he
t
event of a
o
severe earthquake.e
We also
l
may s
a
uffe
f r los
l
s of c
o
ompu
m
terize
i
d inf
i
or
f
ma
r
tion and may b
a
e unable t
l
o m
t
ake time
i
ly filin
i
gs with
i
regu
e
latory agencies in t
i
he
t
event
of catastro
t
ph
o
ic failure of o
o
ur data s
t
torage
a
and backup s
u
ys
s
tems.
Much of our research and development activities and the significant portion of our general and administrative activities are performed
in or managed fro
f
m our facilities in Concord, California, which are within an active earthquake fault zone and are located near a small
plane airpor
r
t. Should a severe earthquake occur or a plane crash into our site, we might be unabl
a e to occupy our facilities or conduct
research and development and general and administrative activities in support of our business and products until such time as our
facilities could be repaired and made operational. Our property and casualty and business interrupt
u ion insurance in general does not
cover losses caused by earthquakes. While we have taken certain measures to protect our scientific
f , technological and commercial assets,
a lengthy or costly disrupt
r
ion due
d
to an earthquake would have a material adverse effect on us. We have also taken measures to limit
damage that may occur from the loss of computerized data due to power outage, system or component failure or corruption of data file
f
s.
However, we may lose critical computerized data, which may be diffi
f cult or impossible to recreate, which may harm our business. We
may be unabl
a e to make timely filin
f
gs with regulatory agencies in the event of catastrophic fai
f lure of our data storage and backup
k
systems,
which may subj
u ect us to fines or adverse consequences, up t
u
o and including loss of our ability to conduct business.
Sign
i
ific
f ant dis
d rupt
u io
t ns of info
n
rmatio
t n tech
t
nology
o
system
t
s or actual or allege
e
d breaches of d
o
at
d a s
t
ecurity c
t
ould adverse
r
ly affe
f ct our
busine
i
ss.
Our business is increasingly dependent on complex and interdependent information technology systems, including internet-based
systems, databa
a
ses and programs, to suppor
u
t our business processes as well as internal and external communications. These include
those that are used directly by our operations and those used by critical service providers and suppliers, including our manufac
f
turing
partners. As use of information technology systems has increased, deliberate attacks, attempts to gain unauthorized access to computer
systems and networks, and unintentional actions or inactions that expose us to security vulnerabi
a lities and incidents have increased in
frequency and sophistication. Our and our suppl
u
ier’s information technology, systems and networks are potentially vulnerabl
a e to
breakdown, ransomware, supply chain attacks, malicious intrus
r
ion and computer viruses which may result in the impairment of
production and key business processes or loss of data or infor
f
mation. We and our suppl
u
iers are also potentially vulnerabl
a e to data security
breaches-whether by (a) intentional or accidental actions or inactions or (b) employees or others-which may expose sensitive data to
unauthorized persons. For example, we have in the past and may in the future be subj
u ect to “phishing” attacks in which third parties
send emails purpor
r
ting to be from reputable sources. Phishing attacks may attempt to obtain personal infor
f
mation, infiltrate our systems
to initiate wire transfer
f s or otherwise obtain proprietary or confid
f ential infor
f
mation. Although we have not experienced any losses as a
result of such attacks or any other breaches of data security, such breaches could lead to the loss of trade secrets or other intellectua
t
l
property, or could lead to the public exposure of personal infor
f
mation (including sensitive personal infor
f
mation) of our employees,
clinical trial patients, distributors, customers and others.
We may be subject to contractua
t
l, regulatory,
r
or legal requirements that obligate us to use industry-
r
standard or reasonabl
a e security
measures to safeguard personal infor
f
mation. A security breach could lead to claims by our customers or other relevant stakeholders that
we have failed to comply with such legal or contractua
t
l obligations. As a result, we could be subject to legal action or our customers
could end their relationships with us. There can be no assurance that the limitations of liabi
a lity in our contracts would be enfor
f
ceable or
adequate or would otherwise protect us from liabi
a lities or damages, and in some cases our customer agreements do not limit our
remediation costs or liabi
a lity with respect to data breaches.
Litigation resulting fro
f
m security incidents may adversely affec
f
t our business. Actual or alleged unauthorized access to our platform,
systems, networks, or physical facilities, or those of our vendors, could result in litigation with our customers or other relevant
stakeholders. These proceedings could for
f
ce us to spend money in defen
f
se or settlement, divert management’s time and attention,
increase our costs of doing business, or adversely affect our reputation. We could be required to funda
f
mentally change our business
activities and practices or modify our products and/or platform capabilities in response to such litigation, which could have an adverse
effe
f ct on our business. If a security breach were to occur, and the confid
f entiality, integrity, or availability of personal information was
disrupt
r
ed, we could incur significant liabi
a lity, or our platform, systems, or networks may be perceived as less desirable, which could
negatively affe
f ct our business and damage our reputation.
We know that certain of our suppl
u
iers have been successful
f ly attacked by certain malware aimed at extracting a ransom. Should such
ransomware breaches occur in the future, production may be impacted, infor
f
mation exfiltrated or other records and information
compromised or lost. Breaches and other inappropriate access can be difficult to detect and any delay in identifyi
f ng them could increase
their harm. While we have implemented security measures designed to protect our data security and infor
f
mation technology systems,
such measures may not prevent such events. Notific
f ations and fol
f low-up actions related to a security breach of one of our suppl
u
iers
could impact our reputation, cause us to incur significant costs, including legal expenses and remediation costs.

55
Any such breaches of security and inapp
a
ropriate access could disrupt
u
our operations, harm our reputation or otherwise have a material
adverse effect on our business, financial condition and results of operations. Further, the costs to respond to a security breach and/or to
mitigate any security vulnerabi
a lities that may be identifie
f d could be significant, our effo
f
rts to address these problems may not be
successful
f , and these problems could result in interrupt
r
ions, delays, cessation of service, negative publicity, loss of customer trus
r
t, less
use of our products and services as well as other harms to our business and our competitive position. Remediation of any potential
security breach may involve signific
f ant time, resources, and expenses, which may result in potential regulatory i
r
nquiries, litigation or
other investigations, and can affect our financial and operational condition.
While we have attempted to limit our liabi
a lity in our contracts, there can be no assurance that contractua
t
l limitations of liabi
a lity are
sufficient to protect us from liabi
a lities, damages, or claims related to our data privacy and security obligations. We cannot be sure that
our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabi
a lities arising out of our privacy and security
practices, that such coverage will continue to be availabl
a e on commercially reasonabl
a e terms or at all, or that such coverage will pay
future claims.
Uncertainties in t
i
he
t
interpretation and applic
l atio
t n of e
o
xi
e st
i in
t
g, new and proposed tax l
a
aw
l
s and regu
e
lations could materially
l
affe
f ct
our tax
t
oblig
l atio
t ns and effe
e
ctiv
t e tax
t
rate.e
The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change. The issuance
of additional guidance related to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the
current or a fut
f ur
t
e U.S. presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside
of the United States, could materially affe
f ct our tax obligations and effective tax rate. To the extent that such changes have a negative
impact on us, including as a result of related uncertainty, these changes may adversely impact our business, financial condition, results
of operations, and cash flows.
The amount of taxes we pay in different jurisdictions depends on the appl
a
ication of the tax laws of various jurisdictions, including the
United States, to our international business activities, tax rates, new or revised tax laws, or interpr
r
etations of tax laws and policies, and
our ability to operate our business in a manner consistent with our corporate struc
r
ture and intercompany arrangements. The taxing
authorities of the jurisdictions in which we operate may challenge our methodologies for pricing intercompany transactions pursuant to
our intercompany arrangements or disagree with our determinations as to the income and expenses attributable to specific jurisdictions.
If such a challenge or disagreement were to occur, and our position was not sustained, we could be required to pay additional taxes,
interest, and penalties, which could result in one-time tax charges, higher effective tax rates, reduced cash flows, and lower overall
profita
f
bi
a lity of our operations. Our financial statements could fai
f l to refle
f ct adequate reserves to cover such a contingency. Similarly, a
taxing authority could assert that we are subject to tax in a jurisdiction where we believe we have not establ
a ished a taxabl
a e connection,
ofte
f n refer
f red to as a “permanent establ
a ishment” under international tax treaties, and such an assertion, if successful
f , could increase our
expected tax liabi
a lity in one or more jurisdictions.
Our ability
i
to use our net ope
o
rating
i
loss carryfo
y
rwards and certain othe
t
r tax
t
attr
t ibutes
t
is uncertain and may be limited
t
.d
Our abi
a lity to use our federal and state net operating loss, or NOL, carryforwards to offs
f et potential fut
f ur
t
e taxable income and related
income taxes that would otherwise be due is dependent upon our generation of fut
f ur
t
e taxable income before the expiration dates of the
NOL carryf
r
or
f
wards (if any), and we cannot predict with certainty when, or whether, we will generate suffi
f cient taxable income to use
all of our NOL carryforwards. Under current law, U.S. federal NOL carryforwards incurred in tax years beginning afte
f r December 31,
2017, may be carried forward indefinitely, but the deduc
d
tibility of such federal NOL carryforwards in a taxable year is limited to 80%
of taxabl
a e income in such year. In general, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a
corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over
a three-year period, the corpor
r
ation’s abi
a lity to use its pre-change NOL carryforwards and other pre-change tax attributes (such as
research and development credit carryforwards) to offset its post-change taxabl
a e income or taxes may be limited. Our equity offe
f rings
and other changes in our stock ownership, some of which are outside of our control, may have resulted or could in the future result in
an ownership change. Although we have completed studies to provide reasonabl
a e assurance that an ownership change limitation would
not apply, we cannot be certain that a taxing authority would reach the same conclusion. If, afte
f r a review or audit, an ownership change
limitation were to app
a
ly, utilization of our domestic NOL and tax credit carryforwards could be limited in fut
f ur
t
e periods and a portion
of such carryf
r
or
f
wards could expire before being utilized to reduce fut
f ur
t
e income tax liabi
a lities. In addition, at the state level, there may
be periods during which the use of NOL carryforwards is suspended or otherwise limited, which could accelerate or permanently increase
state taxes owed. As a result, if we earn net taxabl
a e income, we may be unabl
a e to use all or a material portion of our NOL carryforwards
and other tax attributes, which could potentially result in increased fut
f ur
t
e tax liabi
a lity to us and adversely affect our future cash flo
f ws.
Risks Related to Our Intellectual Property
We may n
a
ot be able t
l
o p
t
rotect our int
i
el
t le
l ctual prope
o
rty o
t
r ope
o
rate our business without inf
i
ri
f ng
i
ing int
i
el
t le
l ctual prope
o
rty r
t
ight
g
s o
t
f
o
othe
t
rs.

56
Our commercial success will depend, in part, on obtaining and maintaining patent protection on our products and successfully defen
f
ding
our products against third-party challenges. Our technology will be protected fro
f
m unauthorized use only to the extent that it is covered
by valid and enfor
f
ceable patents or effec
f
tively maintained as trade secrets. As a result, our success depends in part on our ability to:
•
obtain patents;
•
protect trade secrets;
•
operate without infringing upon the proprietary rights of others; and
•
prevent others fro
f
m infri
f nging on our proprietary rights.
We cannot be certain that our patents or patents that we license from others will be enforceable and afford protection against competitors.
Our patents or patent applications, if issued, may be challenged, invalidated or circumvented. Our patent rights may not provide us with
proprietary protection or competitive advantages against competitors with similar technologies. Others may independently develop
technologies similar to ours or independently duplicate our technologies. For example, we are aware of an expired U.S. patent issued to
a third-party that covers methods to remove psoralen compounds from blood products. We have reviewed the patent and believe there
exist substantial questions concerning its validity. We cannot be certain, however, that a court would hold the patent to be invalid or not
infringed by our platelet or plasma systems. In this regard, whether or not we have infringed this patent will not be known with certainty
unless and until a court interprets the patent in the context of litigation. In the event that we are found
f
to have infringed any valid claim
of this patent, we may, among other things, be required to pay damages. Our patents expire at various dates between 2025 and 2042.
Due to the extensive time required for
f
development, testing and regulatory r
r
eview of our potential products, our patents may expire or
remain in existence for
f
only a short period fol
f lowing commercialization. This would reduc
d
e or eliminate any advantage of the patents.
We cannot be certain that we were the fir
f st to make the inventions covered by each of our issued patents or pending patent applications
or that we were the fir
f st to file patent applications for such inventions. We may need to license the right to use third-party patents and
intellectua
t
l property to continue development and commercialization of our products. We may not be able to acquire such required
licenses on acceptable terms, if at all. If we do not obtain such licenses, we may need to design around other parties’ patents, or we may
not be able to proceed with the development, manufactur
t
e or sale of our products.
Our patents do not cover all of the countries in which we are selling, and planning to sell, our products. We will not be able to prevent
potential competitors from using our technology in countries where we do not have patent coverage. Further, the laws of some foreign
countries may not protect intellectual property rights to the same extent as the laws of the U.S., including the CIS countries, China and
other jurisdictions where we are currently expanding or seeking to expand our commercialization efforts through distributors or
otherwise. For example, we recently formed a joint ventur
t
e with the intent to develop and commercialize blood transfus
f
ion products to
enhance blood safety in the Peoples Republic of China. The prosecution of intellectua
t
l property infri
f ngement and trade secret theft i
f
n
China is more diffi
f cult and unpredictabl
a e than in the United States, and we may also have limited legal recourse in the event our
intellectua
t
l property rights are infringed. In any event, our inability to adequately enforce or protect our intellectua
t
l property rights to
INTERCEPT in China and other for
f
eign jurisdictions where we are currently expanding or seeking to expand our commercialization
effo
f
rts could adversely impact our potential commercial success and harm our business.
In certain countries, including EU Member States, China and India, compulsory licensing laws exist that may be used to compel a patent
owner to grant licenses to third parties, for reasons such as non-use of the patented subj
u ect matter within a certain period of time afte
f r
patent grant or commercializing in a manner that is cost-prohibitive in the country. In those countries, we may have limited remedies if
our patents are infringed or if we are compelled to grant a license for the INTERCEPT Blood System to a third-party, which could
materially diminish the value of such patents. This could adversely impact our potential product revenue opportunities.
We may face
f
litigation requiring us to defend against claims of infri
f ngement, assert claims of infringement, enfor
f
ce our patents, protect
our trade secrets or know-how or determine the scope and validity of others’ proprietary rights. Patent litigation is costly. In addition,
we may require interference proceedings before the U.S. Patent and Trademark Office to determine the priority of inventions relating to
our patent applications. Litigation or interference proceedings could be expensive and time consuming, and we could be unsuccessful
f
in our effo
f
rts to enfor
f
ce our intellectual property rights. We may rely, in certain circumstances, on trade secrets to protect our technology.
However, trade secrets are difficult to protect. We protect our proprietary technology and processes, in part, by confid
f entiality
agreements with employees, consultants and contractors. These agreements may be breached and we may not have adequate remedies
for any breach or our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our
employees, consultants or contractors use intellectua
t
l property owned by others, disputes also may arise as to the rights in related or
resulting know-how and inventions.
Risks Related to Our Common Stock
Our stock price is v
i
olat
l il
t e a
l
nd your investment may s
a
uffe
f r a declin
l
e in v
i
alue.e
The market price for our common stock has varied between a high of $2.42 on March 6, 2024, and a low of $1.52 on November 1, 2024,
in the twelve-month period ended December 31, 2024. As a result of flu
f ctua
t
tions in the price of our common stock, you may be unabl
a e
to sell your shares at or above the price you paid for them. The market price of our common stock is likely to continue to be volatile and

57
subj
u ect to significant price and volume flu
f ctua
t
tions in response to market, industry a
r
nd other fac
f
tors, including the risk fact
f
ors described
in this “Risk Factors” section. The market price of our common stock may also be dependent upon the valuations and recommendations
of the analysts who cover our business. If the results of our business do not meet these analysts’ forecasts, the expectations of investors
or the fin
f ancial guidance we provide to investors in any period, the market price of our common stock could decline.
In addition, the stock markets in general, and the markets for biotechnology stocks in particular, have experienced significant volatility
that has often been unrelated to the operating performance of particular companies. These broad market fluctuations have in the past
and may in the fut
f ur
t
e adversely affect the trading price of our common stock. In the past, fol
f lowing periods of volatility in the market
or significant price declines, securities class-action litigation has ofte
f n been institut
t ed against companies. Such litigation, if institut
t ed
against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely
affe
f ct our business, financial condition, results of operations and growth prospects.
The exc
e
lusive forum provisi
i ons in o
i
ur amended and restat
t ed
t
bylaws could l
l
im
l
it our stockho
k
lder
d
s’
r
abilit
i
y t
t
o o
t
btai
t n a
i
favorable j
l
udic
d ial
forum for
f
disp
i
utes
t
with
i
us or any o
n
f o
o
ur dire
i
ctor
t
s,
r
offi
f cers or empl
m oy
l
ees, o
s
r our stoc
t
kholde
l
rs, or the under
d
writers of any o
n
ffe
o
ring
i
giving
i
rise
i
to such clai
l m,
i
which may disc
i
ourage
a
lawsuits
i
with
i
respect to s
t
uch claims.
Our amended and restated bylaws provide that, unless we consent to the selection of an alternative for
f
um
r
, the Court of Chancery o
r
f the
State of Delaware (or, if and only if the Court of Chancery o
r
f the State of Delaware lacks subj
u ect matter jurisdiction, any state court
located within the State of Delaware or, if and only if all such state courts lack subj
u ect matter jurisdiction, the fed
f
eral district court for
f
the District of Delaware) will be the sole and exclusive for
f
um
r
for:
•
any derivative claim or cause of action or proceeding brought on our behalf;f
•
any claim or cause of action for
f
breach of a fid
f uc
d
iary duty owed by any of our current or former directors, offi
f cers or other
employees, or our stockholders, to us or to our stockholders;
•
any claim or cause of action against us or any of our current or former directors, offi
f cers or other employees, or our
stockholders, arising out of or pursuant to any provision of the General Corporation Law of the State of Delaware, our
certific
f ate of incorpor
r
ation, or our bylaws;
•
any claim or cause of action seeking to interpret, apply, enforce or determine the validity of our certific
f ate of incorpor
r
ation
or bylaws;
•
any claim or cause of action as to which the General Corporation Law of the State of Delaware confer
f s jurisdiction on the
Court of Chancery o
r
f the State of Delaware; and
•
any claim or cause of action against us or any of our current or former directors, offi
f cers or other employees, or our
stockholders, governed by the internal affairs doctrine or otherwise related to our internal affa
f irs.
In addition, Section 22 of the Securities Act creates concurrent jurisdiction for
f
federal and state courts over all claims brought to enforce
any dut
d y or liabi
a lity created by the Securities Act of 1933, as amended, or the Securities Act, or the rules and regulations thereunder.
Our amended and restated bylaws provide that the fed
f
eral district courts of the United States of America will, to the ful
f lest extent
permitted by law, be the exclusive for
f
um
r
for resolving any complaint asserting a cause of action arising under the Securities Act, or the
Federal Forum
r
Provision, including for all causes of action asserted against any defen
f
dant named in such complaint. For the avoidance
of doubt, this provision is intended to benefit and may be enfor
f
ced by us, our offi
f cers and directors, the underwriters to any offering
giving rise to such complaint, and any other professional entity whose profession gives authority to a statement made by that person or
entity and who has prepared or certifie
f d any part of the documents underlying the offering. The appl
a
ication of the Federal Forum
r
Provision means that suits brought by our stockholders to enforce any duty or liabi
a lity created by the Securities Act must be brought in
federal court and cannot be brought in state court, and our stockholders cannot waive compliance with the federal securities laws and
the rul
r es and regulations thereunder.
While the Delaware courts have determined that such choice of forum provisions are fac
f
ially valid and several state trial courts have
enforced such provisions and required that suits asserting Securities Act claims be filed in fed
f
eral court, there is no guarantee that courts
of appeal will affi
f rm the enfor
f
ceability of such provisions, and a stockholder may nevertheless seek to bring a claim in a venue other
than those designated in the exclusive forum provisions. In such an instance, we would expect to vigorously assert the validity and
enforceabi
a lity of the exclusive forum provisions of our amended and restated bylaws. This may require significant additional costs
associated with resolving such action in other jurisdictions, which costs could be borne by stockholders, and there can be no assurance
that the provisions will be enforced by a court in those other jurisdictions.
Any person or entity purchasing or otherwise acquiring or holding any interest in any of our securities shall be deemed to have notice
of and consented to the exclusive for
f
um
r
provisions in our amended and restated bylaws, including the Federal Forum Provision. These
provisions could limit a stockholder’s ability to bring a claim in a judicial forum that it fin
f ds favorable for disputes with us or any of our
directors, offi
f cers or other employees, or our stockholders, or the underwriters of any offering giving rise to such claims, which may
discourage lawsuits with respect to such claims. Furthermore, if a court were to fin
f d the exclusive for
f
um
r
provisions contained in our

58
bylaws to be inappl
a
icable or unenfor
f
ceable in an action, we may incur additional costs associated with resolving such action in other
jurisdictions, which could have a material and adverse impact on our operating results and our financial condition.
Because we do n
d
ot anticipate p
t
aying any cash dividends o
d
n our common stoc
t
k in t
i
he
t
foreseeable f
l
ut
f
ure, capi
a ta
i l appr
a
eciatio
t n, if any,
n
will
i
be your sole source of gain.
i
We have never declared or paid cash dividends on our common stock and do not intend to pay cash dividends on our common stock in
the for
f
eseeable future. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our
business. Additionally, any cash dividends declared or paid would require prior written consent under the terms of our Term Loan Credit
Agreement and Revolving Loan Credit Agreement. As a result, capi
a tal appr
a
eciation, if any, of our common stock will be your sole
source of gain for the foreseeable future.
General Risk Factors
We are oblig
l ated
t
to develop
l
and maint
i
ai
t n p
i
rope
o
r and effe
f ctiv
t e int
i
er
t
nal control over fina
i
ncial reporting. In the fut
f
ure, we may n
a
ot
complete our analysis o
i
f o
o
ur internal contro
t
l over fina
i
ncial reporting in a
i
time
i
ly manner, or these int
i
er
t
nal controls m
l
ay not be
determined to be effe
f ctiv
t e, which may adverse
r
ly affe
f ct investor
t
confid
f en
d
ce in our compan
m
y a
n
nd, a
d
s a result, the value of our common
stoc
t
k.
We are required, pursuant to Section 404 of the Sarba
r
nes-Oxley Act, to fur
f
nish a report by management on, among other things, the
effe
f ctiveness of our internal control over fin
f ancial reporting. This assessment includes disclosure of any material weakness identifie
f d
by our management in our internal control over fin
f ancial reporting, as well as a statement that our independent registered public
accounting fir
f m has issued an attestation report on the effe
f ctiveness of our internal control over fin
f ancial reporting.
Complying with Section 404 requires a rigorous compliance program as well as adequate time and resources. As a result of expanding
our commercialization efforts, developing, improving and expanding our core information technology systems as well as implementing
new systems to suppor
u
t our sales, suppl
u
y chain activities and reporting capabilities, all of which require significant management time
and support, we may not be able to complete our internal control evaluation, testing and any required remediation in a timely fashion.
For example, with respect our joint venture formed with the intent to develop and commercialize blood transfus
f
ion products to enhance
blood safety in the Peoples Republ
u ic of China, we had no prior experience designing and maintaining effe
f ctive internal control over
financial reporting for
f
joint ventures or for
f
economic entities in China. Failure to adequately maintain an effe
f ctive internal control
structur
t
e over the joint venture’s financial results may result in significant defic
f iencies or material weaknesses in our internal control
over fin
f ancial reporting. Additionally, if we identify o
f
ne or more material weaknesses in our internal control over fin
f ancial reporting,
we will not be unabl
a e to assert that our internal controls are effe
f ctive. Should our internal controls be deemed ineffe
f ctive, our ability to
obtain additional fin
f ancing, or obtain additional fin
f ancing on favorable terms, could be materially and adversely affected which, in turn,
could materially and adversely affect our business, our financial condition and the value of our common stock. If we are unabl
a e to assert
that our internal control over fin
f ancial reporting is effe
f ctive in the future, or if our independent registered public accounting fir
f m is
unabl
a e to express an opinion or expresses an adverse opinion on the effectiveness of our internal controls in the fut
f ur
t
e, investor
confid
f ence in the accuracy and completeness of our financial reports could be fur
f
ther eroded, which would have a material adverse
effe
f ct on the price of our common stock.
Provisions of our charter
t
documents, o
s
ur compensatory arrangements and Delaw
l
are law
l
could m
l
ake it more diffi
i
cult for a third-
party to acquire us, even if the offe
o
r may be consider
d
ed benefi
e cial by our stockho
k
lder
d
s.
r
Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or prevent
a change in control. The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to the abi
a lity
of a third-party to acquire control of us, even if a change in control would be benefic
f ial to our existing stockholders. Additionally,
provisions of our amended and restated certific
f ate of incorpor
r
ation and bylaws could deter, delay or prevent a third-party fro
f
m acquiring
us, even if doing so would benefit
f our stockholders, including without limitation, the authority of the board of directors to issue, without
stockholder app
a
roval, prefer
f red stock with such terms as the board of directors may determine. In addition, our executive employment
agreements, change of control severance benefit plan and equity incentive plans and agreements thereunder provide for certain severance
benefits in connection with a change of control of us, including single-trigger equity vesting acceleration benefit
f s with respect to
outstanding stock options, which could increase the costs to a third-party acquirer and/or deter such third-party from acquiring us.
Item 1B. Unresolved Staf
t
f C
f
om
C
mentst
None.
Item 2. Propertie
t s
Our corpor
r
ate headquarters, which includes our principal executive offi
f ces, is located in Concord, Califor
f
nia. We lease this faci
f
lity,
which includes 84,631 square feet and includes laboratory s
r
pace for blood safety research and supports general administrative, marketing
and technical support func
f
tions. Of the 84,631 square feet, we sublease 14,908 square feet to a subtenant under a three-year lease ending
March 31, 2025 and ceased using appr
a
oximately 15,000 square feet of rentable area of corporate office building in the third quarter of
2023. We are currently marketing our vacant space and subl
u eased space for lease afte
f r March 31, 2025. We also lease an office facility

59
in Amersfoor
f
t, the Netherlands, which is used for selling and administrative func
f
tions. We believe that our current and fut
f ur
t
e faci
f
lities
will be adequate for the foreseeabl
a e fut
f ur
t
e.
Item 1C. Cybersecurity
i
Risk
i
manage
a
ment and strateg
t
y
g
We have implemented and maintain various information security processes designed to identify,
f
assess and manage material risks from
cybersecurity threats to our critical computer networks, third party hosted services, communications systems, hardware and softw
f
are,
and our critical data, including intellectua
t
l property and confid
f ential information that is proprietary, strategic or competitive in nature
or Information Systems and Data.
Our infor
f
mation security function, led by our Senior Director, IT & Facilities and our Senior Manager, IT Infrastructur
t
e and Operations,
helps identify,
f
assess and manage our cybersecurity threats and risks. Our infor
f
mation security function identifie
f s and assesses risks
from cybersecurity threats by monitoring and evaluating our threat environment using various methods and resources including, for
example automated tools, internal and external audits, external intelligence feed
f
s and third-party threat assessments; conducting scans
of the threat environment, threat assessments for internal and external risk and vulnerabi
a lity assessments to identify v
f
ulnerabi
a lities;
evaluating our and our industry’
r
s risk profile and threats reported to us; subs
u
cribing to reports and services that identify c
f
ybersecurity
threats; analyzing reports of threat and threat actors and coordinating with law enfor
f
cement concerning threats; and internal tabletop
incident response exercises.
Depending on the environment, we implement and maintain various technical, physical, and organizational measures, processes,
standards and policies designed to manage and mitigate material risks from cybersecurity threats to our Information Systems and Data,
including, for example: an incident response plan, disaster recovery/business continuity plans and cybersecurity insurance; incident
detection and response, risk assessments, systems monitoring and penetration testing; encrypt
r
ion of data, network security controls,
access controls, physical security and asset management, tracking and disposal; and employee training.
Our assessment and management of material risks fro
f
m cybersecurity threats are integrated into our overall risk management
processes. For example, cybersecurity risk is addressed as a component of our enterprise risk management process; the infor
f
mation
security function works with management to prioritize our risk management processes and mitigate cybersecurity threats that are more
likely to lead to a material impact to our business; our senior management evaluates material risks from cybersecurity threats against
our overall business objectives and reports to the audit committee of the board of directors, which evaluates our overall enterprise risk.
We use third-party service providers to assist us from time to time to identify,
f
assess, and manage material risks fro
f
m cybersecurity
threats, including for example profes
f
sional service firms, threat intelligence service providers, cybersecurity software providers,
managed cybersecurity service providers, penetration testing fir
f ms and for
f
ensic investigators.
We use third-party service providers to perform a variety of functions throughout our business, such as third-party distributors for
f
our
products in certain countries and third-party suppliers for the manufac
f
ture of our products, as well as third-party application providers
and third-party hosting companies. Depending on the natur
t
e of the services provided, the sensitivity of the Infor
f
mation Systems and
Data at issue, and the identity of the provider, we may impose contractua
t
l obligations related to cybersecurity on the provider.
For a description of the risks fro
f
m cybersecurity threats that may materially affe
f ct us and how they may do so, see our risk factors under
“Item 1A—Ri
—
sk
i
Factorsr ” in Part I of this Annual Report on Form 10-K, including the risk fact
f
or captioned, “Signi
i
fi
i cant disr
i uptions of
info
n rmation technology syst
y ems or actual or allege
e
d breaches of d
o
at
d a security could adverse
r
ly affe
f ct our business.”
Governance
Our board of directors addresses our cybersecurity risk management as part of its general oversight function. The audit committee of
the board of directors is responsible for overseeing our cybersecurity risk management processes, including oversight and mitigation of
risks fro
f
m cybersecurity threats.
Our cybersecurity risk assessment and management processes are implemented and maintained by members of management, including
our Senior Director, IT & Facilities and our Senior Manager, IT Infrastructur
t
e and Operations. Our Senior Director, IT & Facilities has
over 26 years of experience in systems engineering, network design and security and is a Certifie
f d Infor
f
mation Systems Security
Profes
f
sional, or CISSP. Our Senior Manager, IT Infra
f structur
t
e and Operations has over 24 years of experience in network administration,
security administration and incident response and remediation.
Our Senior Director, IT & Facilities and our Senior Manager, IT Infrastructur
t
e and Operations are responsible for helping to integrate
cybersecurity risk considerations into our overall risk management strategy and communicating key priorities to relevant personnel. Our
Senior Director, IT & Facilities and our Senior Manager, IT Infrastructur
t
e and Operations are responsible for helping prepare for
f
cybersecurity incidents, appr
a
oving cybersecurity processes and reviewing security assessments and other security-related reports.
Our cybersecurity incident response plan is designed to escalate certain cybersecurity incidents to members of management depending
on the circumstances, including Senior Director, IT & Facilities, Chief Legal Offi
f cer, Chief Financial Offic
f er, Chief Executive Officer
and others. Those individuals work with our incident response team to help us mitigate and remediate cybersecurity incidents of which

60
they are notifie
f d. In addition, our incident response plan includes reporting to the audit committee of the board of directors for
f
certain
cybersecurity incidents.
The audit committee of the board of directors receives periodic reports from our Senior Director, IT & Facilities and third-party experts
concerning our significant cybersecurity threats and risk and the processes we have implemented to address them. The board of directors
also has access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.
Item 3. Legal
e
Proceedin
d
gs
None.
Item 4. Mine
i
Safe
a ty Disc
i
losures
Not appl
a
icable.

61
PART II
Item 5. Market for Registrant’s C
’
om
C
mon Equity,
t
Related Sto
S ckho
k
lder
d
Matters and Iss
I uer Purchases of Equity
i
Securiti
i es
Our common stock is traded on the Nasdaq Global Market under the symbol “CERS”. On February 6
r
, 2025, we had 115 holders of
record of our common stock.
Dividends
We have not declared or paid dividends on our common stock and do not intend to pay cash dividends on our common stock in the
foreseeable future.
Stock Perfor
f
mance Graph (1)
The fol
f lowing graph shows the total stockholder retur
t
n of an investment of $100 in cash (and the reinvestment of any dividends
thereafter) on December 31, 2019, and tracked the performance through December 31, 2024, for (i) our common stock, (ii) the US
Benchmark Medical Suppl
u
iers TR, and (iii) the Nasdaq Stock Market (United States) Index. Our stock price performance shown in the
graph below is based upon
u
historical data and is not indicative of fut
f ur
t
e stock price performance.
Comparison of 5-year Cumulative Total Return on Investment
December 31,
2019
2020
2021
2022
2023
2024
Cerus Corpor
r
ation
$
100.00
$
163.98
$
161.37
$
86.49
$
51.18
$
36.49
Nasdaq US Benchmark Medical
Suppl
u
ies TR
100.00
125.26
151.98
99.65
105.43
95.87
Nasdaq
100.00
135.23
194.24
235.78
226.24
291.03
(1)
The graph
a
and the other infor
f
mation furnished in this section is not “soliciting material,” is not deemed “file
f
d” with the SEC and
is not to be incorporated by references to any fil
f ing of Cerus
r
Corporation under the Securities Act of 1933, as amended or the
Exchange Act, whether made befor
f
e or after the date hereof and irrespective of any general incorpor
r
ation language in such filing.
Item 6. Reserved
Item 7. Manage
a
ment’s Disc
i
ussion and Analysis o
i
f F
o
in
F
ancial Condit
d io
t n and Results o
t
f O
o
pe
O
rations

62
This disc
i
ussion and analys
l
is should be read in conjunction with our audited consolidat
d ed financial statements a
t
nd the accompany
m
ing
notes included in this A
i
nnual Repo
e
rt on Form 10-K for
f
the year ended December 31, 2024. Operating results for the year ended
December 31, 2024, are not necessarily indicative of r
o
esults that may o
a
ccur in future periods. Thi
T s d
i
iscussion contains forward-looking
statements that involve risks and uncertainties. When reviewing the disc
i
ussion below, you should keep
k
in mind the substantial risks and
uncertainties that impa
m
ct our business, including but not limited to the risk
i
s a
k
nd uncertainties des
d
cribed in “Risk Fac
F
tors” in Part I,I
Item 1A in this Annual Repor
e
t on For
F
m 10-K. These risks and uncertainties could c
l
ause actual results t
t
o differ materially from those
projected in forward-looking statements c
t
ontained in this r
i
eport or implied by past results and trends.
Overview
Since our inception in 1991, we have devoted subs
u
tantially all of our effo
f
rts and resources to the research, development, clinical testing
and commercialization of the INTERCEPT Blood System. Our INTERCEPT Blood System is intended for
f
use with blood components
and certain of their derivatives: plasma, platelets, red blood cells and to produce INTERCEPT Fibrinogen Complex, or IFC, and pathogen
reduced plasma, cryoprecipitate reduced. The INTERCEPT Blood System for
f
platelets, or platelet system, and the INTERCEPT Blood
System for plasma, or plasma system, have received a broad range of regulatory a
r
ppr
a
ovals and certifications, and are being marketed
and sold in a number of countries around the world, including the U.S., certain countries in Europe, the Commonwealth of Independent
States, or CIS, the Middle East, and Latin America and selected countries in other regions of the world. Additionally, we have received
FDA appr
a
oval for
f
the INTERCEPT Blood System for Cryoprecipitation which uses our plasma system to produce IFC for the treatment
and control of bleeding, including massive hemorrhage, associated with fibrinogen defic
f iency. In addition, the INTERCEPT Blood
System for Cryoprecipitation is used to produce pathogen reduc
d
ed plasma, cryoprecipitate reduced. We currently sell the platelet and
plasma systems using our direct sales for
f
ce and through distributors and we sell IFC or disposable kits to manufact
f
ure
t
IFC in the U.S.
using our direct sales for
f
ce.
The platelet system is appr
a
oved by the FDA in the U.S. for ex vivo preparation of pathogen-reduced apheresis platelet components
collected and stored in 100% plasma or InterSol in order to reduc
d
e the risk of transfus
f
ion-transmitted infect
f
ion, or TTI, including sepsis,
and as an alternative to gamma irradiation for
f
prevention of transfusion-associated graft v
f
ersus host disease or TA-GVHD. The plasma
system is approved by the FDA in the U.S. for ex vivo preparation of pathogen-reduced, whole blood derived or aphe
a
resis plasma in
order to reduc
d
e the risk of TTI when treating patients requiring therapeutic plasma transfusion, and as an alternative to gamma irradiation
for prevention of TA-GVHD. Outside of the U.S., we have received CE Certific
f ates of Confor
f
mity issued by our Notifie
f d Body in
accordance with the European Union Medical Devices Regulation 2017/745, or MDR, for the platelet system and the plasma system
and affixed the CE Mark to these products.
The INTERCEPT Blood System for red blood cells, or the red blood cell system, is currently in development and has not been
commercialized anywhere in the world. We file
f
d our application for
f
confor
f
mity assessment to obtain a CE Certific
f ate of Confor
f
mity to
affi
f x the CE Mark to the red blood cell system in December 2018 under the Medical Device Directive 93/42/EEC, or MDD, and in June
2021, we completed the resubm
u
ission of our application under the MDR. In October 2024, we announced that TÜV-SÜD’s, our Notified
Body for the red blood cell system, in consultation with the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for
f
the red blood cell system, reviewed infor
f
mation regarding the medicinal product or active pharmaceutical ingredient of our MDR
application and concluded that the data provided were insuffi
f cient to support the proposed classification of the impurity profile of the
final product, necessitating the closure of our MDR appl
a
ication without an approval. In collaboration with TÜV-SÜD, we are assessing
strategies for a potential new MDR app
a
lication, including data to address the classification questions raised by CBG. We cannot predict
with certainty when, if ever, we will be able to satisfactorily address CBG’s conclusions and as such cannot predict if or when we will
subm
u
it a new MDR app
a
lication for
f
the red blood cell system and, if subm
u
itted, when a decision concerning certific
f ation would occur.
In addition, as a result of the failure to obtain app
a
roval of our MDR appl
a
ication, our product development costs will be ongoing. See
also the risk fact
f
or entitled “The red blood cell system is currently in development and may never receive any marketing approvals or
CE Certific
f ates of Confor
f
mity” under “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report on Form 10-K. In 2017, we initiated a Phase 3
clinical, double-blind study in the U.S., known as the RedeS study, to assess the safet
f y and effi
f cacy of INTERCEPT-treated red blood
cells when compared to conventional, red blood cells. We also recently announced positive topline results from a Phase 3 clinical trial
in the U.S., known as the ReCePI study,
t
that was designed to evaluate the effi
f cacy and safet
f y of INTERCEPT-treated red blood cells in
patients requiring transfus
f
ion for
f
acute blood loss during surgery. We announced that the ReCePI study met its primary effi
f cacy
endpoint, demonstrating non-inferiority for
f
INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute
kidney injury (
r
AKI) fol
f lowing transfus
f
ion of study RBCs. We continue to believe that we will need to conduct and complete, and
generate acceptabl
a e data fro
f
m an additional Phase 3 clinical trial in chronic anemia patients in the U.S., in vitro studi
t
es, and other
necessary activities befor
f
e the FDA will consider our red blood cell system for potential approval. We anticipate initiating a modular
PMA appl
a
ication to the FDA upon
u
the anticipated completion of the RedeS clinical trial. While we previously anticipated that the
completion of the RedeS clinical trial and the planned fin
f al PMA module submission would occur in the second half of 2026, clinical
trial enrollment at additional RedeS clinical trial sites recently commenced later than previously anticipated and we are continuing to
assess the potential impact of that delay on the anticipated timing for
f
completion of the RedeS clinical trial and the planned fin
f al PMA
module submission. In any event, for
f
our planned modular PMA appl
a
ication, we will seek to introduce supplemental clinical data we

63
obtained fro
f
m European clinical trials, though we cannot assure you that we will be able to demonstrate comparabi
a lity or that the FDA
will allow supplemental clinical European data. In addition, if we are unabl
a e to enroll a sufficient number of patients for
f
the RedeS study
t
to generate the data needed for licensure, we will need to reach agreement with the FDA on sufficiency of fewer patients, or a new
pathway to generate suffi
f cient data for
f
the red blood cell system, including the potential for
f
additional Phase 3 clinical trials beyond
what we are currently contemplating. We must also demonstrate to the FDA an abi
a lity to defin
f e, test and meet acceptabl
a e specifications
for our current manufact
f
ur
t
ed compounds used to prepare INTERCEPT-treated red blood cells before we can initiate our planned modular
PMA appl
a
ication submission to and seek regulatory approval of the red blood cell system fro
f
m the FDA. We do not know whether or
not the FDA will have a similar perspective on the information regarding the medicinal product as CBG, or that we will be able to
answer such questions satisfac
f
torily, should they arise.
We have agreements with Biomedical Advanced Research and Development Authority, or BARDA, part of the U.S. Department of
Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, under which we receive fundi
f
ng from
BARDA to support the development of our red blood cell system, including clinical and regulatory d
r
evelopment programs in support
of potential licensure, and development, manufact
f
ur
t
ing and scale-up activities, as well as activities related to broader implementation
of all three INTERCEPT systems in areas of emerging pathogens. The initial agreement currently expires in September 2026 and the
new agreement currently expires in September 2030. The ReCePI study was funde
f
d and the RedeS and other studi
t
es are being funded
as part of our initial BARDA agreement and BARDA reimburses us for
f
allowabl
a e direct contract costs, as such costs are incurred, and
for allowabl
a e indirect costs under both agreements. If we are unabl
a e to access all of the activities and associated reimbursement amounts
for the remaining options availabl
a e under our new BARDA agreement, we will need to fund the activities required to satisfy the
requirements for
f
PMA licensure in the U.S. See the discussion under “Government contracts” below for
f
more information. Should those
amounts be inaccessible and should we be unabl
a e to self-fund the remaining initiatives, successful
f
completion of the development of
the red blood cell system may require us to obtain additional capital in order to obtain any regulatory a
r
ppr
a
ovals for and commercialize
this product. In addition, if we are unabl
a e to obtain fro
f
m our suppl
u
iers sufficient clinical quantities of the active compounds for our red
blood cell system meeting defined quality and regulatory s
r
pecifications, if our suppl
u
iers are not able to maintain regulatory c
r
ompliance
or if we experience additional delays in enrollment or completion of the RedeS study, our product development costs would likely
increase.
In November 2020, we received FDA approval for
f
the INTERCEPT Blood System for Cryoprecipitation. We commercialize and sell
finished IFC made by our manufactur
t
ing blood center partners and other blood centers directly to hospitals and indirectly through certain
blood centers. Similar to our platelet and plasma products, any blood center manufact
f
ur
t
ing IFC will need to complete its process
validations and obtain site-specific licenses fro
f
m the FDA Center for
f
Biologics Evaluation and Research, or CBER, before we or they
can sell finished IFC in interstate commerce. While all of our manufact
f
ur
t
ing partners have now received their Biologics License
Application, or BLAs, fro
f
m CBER, we plan to continue working with any other U.S.-based blood centers producing IFC to suppor
u
t their
licensure applications. Delays in obtaining these licenses have adversely impacted and additional delays will adversely impact the
nationwide availabi
a lity of IFC in the U.S. In addition, we have also entered into certain agreements with blood centers who will purchase
the fin
f ished IFC from us to sell to their hospital customers, and with blood center and blood center affi
f liate organizations to sell
INTERCEPT Blood System for Cryoprecipitation kits to produce fin
f ished IFC for their own sales effo
f
rts to hospitals. Furthermore,
most of our agreements with blood center manufact
f
ur
t
ing partners do not contain minimum production requirements. If our blood center
manufac
f
turing partners do not produce suffi
f cient quantities of IFC, or at all, our commercialization efforts will be negatively impacted.
However, until we sell sufficient INTERCEPT Blood System for Cryoprecipitation kits to blood center affi
f liate organizations, expand
the number of manufact
f
ur
t
ing partners producing IFC for us, or more blood centers producing IFC receive approval of their BLAs, our
IFC sales will be limited.
We have borrowed and, in the future, may borrow additional capital fro
f
m institutional and commercial banking sources to fund fut
f ur
t
e
growth, including pursuant to the Amended and Restated Credit, Security and Guaranty Agreement (Term Loan), or the Term Loan
Credit Agreement, and Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan), or the Revolving Loan
Credit Agreement, as described below, or potentially pursuant to new arrangements with diffe
f rent lenders. We have borrowed and may
in the fut
f ur
t
e borrow fun
f
ds on terms that may include restrictive covenants, including covenants that restrict the operation of our business,
liens on assets, high effective interest rates, fin
f ancial performance covenants and repayment provisions that reduce cash resources and
limit future access to capital markets. In addition, unless we restruc
r
ture our credit agreements prior to April 1, 2026, or qualify f
f
or
f
and
exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement
will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due
d
in cash, which would negatively impact our
availabl
a e working capital. Should interest rates increase, the rates that we are obligated to pay under our credit agreements would
increase, leading to higher interest expense. In addition, we expect to continue to opportunistically seek access to the equity capital
markets to support our development effor
f
ts and operations, including through the Controlled Equity Offe
f ringSM Sales Agreement, as
mended, or the Sales Agreement. To the extent that we raise additional capital by issuing equity securities, our stockholders may
experience subs
u
tantial dilution. To the extent that we raise additional funds
f
through collabor
a
ation or partnering arrangements, we may
be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant
licenses on terms that are not favorabl
a e to us, or issue equity that may be substantially dilutive to our stockholders.

64
As a result of economic conditions, general global economic uncertainty, political change, war, the effe
f cts of infla
f tionary pressures,
including those resulting from new tariffs and escalating trade tensions, and other fac
f
tors including past and potential fut
f ur
t
e U.S. bank
failures, we do not know whether additional capital will be availabl
a e when needed, or that, if availabl
a e, whether we will be able to obtain
additional capital on reasonabl
a e terms. Specifically, monetary policies of many countries, as well as recent bank fai
f lures, have
significantly disrupt
r
ed global fin
f ancial markets, and may limit our ability to access capital, which could in the future negatively affect
our liquidity. As a result of stimulus programs and global events over the past few years, the U.S. and many countries are currently
experiencing an inflationary environment. In addition, the U.S. Federal Reserve in the past has raised, and may again raise, interest rates
in response to concerns about inflation. Moreover, the U.S. Federal Reserve may not lower interest rates as quickly as markets expect,
if at all, which in tur
t
n could negatively impact equity values, including the value of our common stock. Furthermore, our vendors and
suppl
u
iers may raise prices in an inflationary environment, including as a result of new tariffs
f
imposed by the new Trum
r
p administration
and retaliatory tariffs imposed by China and other countries, costs to transport our products may increase and access to timely shipping
may be limited. If we are unabl
a e to raise additional capital due
d
to the volatile global fin
f ancial markets, general economic uncertainty or
other fact
f
ors, we may need to curtail planned development or commercialization activities. In addition, we may need to obtain additional
funds to complete development activities for the red blood cell system necessary f
r
or
f
CE Certific
f ates of Confor
f
mity in the EU, if costs
are higher than anticipated or we encounter further delays. In this regard, our product development costs will be ongoing in connection
with our failure to obtain appr
a
oval of our MDR appl
a
ication and the potential subm
u
ission of a new MDR appl
a
ication and would also
increase if existing clinical data is insufficient for
f
us to either subm
u
it or potentially obtain appr
a
oval of any such new appl
a
ication. We
may need to obtain additional fundi
f
ng to conduct additional randomized controlled clinical trials for existing or new produc
d
ts,
particularly if we are unabl
a e to access any additional portions of the fundi
f
ng contemplated by our government contracts, and we may
choose to defer
f
such activities until we can obtain suffi
f cient additional fundi
f
ng or, at such time our existing operations provide suffi
f cient
cash flo
f w to conduct these trials.
Although we received FDA approval of our platelet and plasma systems in December 2014, our U.S. commercial efforts continue to be
largely foc
f
used on enabling blood centers that are using INTERCEPT to optimize production and increase the number of platelet units
produced and made availabl
a e to patients and continuing to develop awareness of INTERCEPT’s product profile relative to other platelet
and plasma products, including conventional, un-treated components. In addition, to address the entire market in the U.S., customers
will need to modify their operating practices, or we will need to develop, test and obtain FDA approval of additional config
f urations of
the platelet system. All U.S. blood centers must be compliant with the FDA guidance document, “Bacterial Risk Control Strategies for
Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availabi
a lity of Platelets for
f
Transfus
f
ion,” or the
Final Guidance Document. Although the INTERCEPT Blood System is one of the options availabl
a e to U.S. blood centers for
compliance, we cannot predict if U.S. customers will continue to adopt INTERCEPT over other options or at what levels. Should we be
unabl
a e to manufac
f
ture INTERCEPT in sufficient quantities in a timely manner, or have adequate resources to assist customers with
implementing the INTERCEPT Blood System, U.S. blood centers may be for
f
ced to use alternate options allowed by the guidance
document, which could permanently impact our ability to convert those blood centers to INTERCEPT users.
We understand that we will be required to obtain new PMAs for our INTERCEPT Blood System for Platelets and for
f
Plasma with our
new LED-based illuminator. We are currently working with the FDA to understand the data requirements for
f
those PMAs. If we are
unabl
a e to generate the required data for
f
new PMAs, use of INTERCEPT in the United States will be limited to continued use with the
existing illuminator, which we have a limited number of devices availabl
a e and for which we have a limited time that we can continue to
suppor
u
t and maintain.
Outside of the U.S., we recognize product revenues fro
f
m the sale of our platelet and plasma systems in a number of countries around
the world including those in Europe, the CIS, and the Middle East. We utilize both our direct sales organization and regional distributors
to market and sell our platelet and plasma systems in these international markets. Our commercial efforts outside the U.S. are focused
on increasing market adoption with our existing customer relationships and building demand in new geographies.
Generally, we enter into customer agreements for a specifie
f d term and varying options or extensions beyond the initial term. We cannot
assure that all customers will use our products at historical levels or at all since securing long-term purchase volume commitments is
not always possible, given the unpredictabl
a e natur
t
e of blood collection and usage. We also cannot provide any assurance that we will
be able to secure any subsequent contracts with our customers or that the terms, including the pricing or committed volumes, if any, of
any fut
f ur
t
e contract will be equivalent or supe
u
rior to the terms under our current contracts.
If we are unabl
a e to gain widespread commercial adoption in markets where our blood safety products are appr
a
oved for
f
commercialization, including the U.S., we will have difficulties achieving profita
f
bi
a lity. In order to commercialize all of our produc
d
ts
and product candidates, we will be required to conduct significant research, development, preclinical and clinical evaluation,
commercialization and regulatory c
r
ompliance activities for
f
our produc
d
ts and product candidates, which, together with anticipated selling,
general and administrative expenses, are expected to result in subs
u
tantial losses. Accordingly, we may never achieve a profitabl
a e level
of operations in the fut
f ur
t
e.

65
In addition to the anticipated product revenues fro
f
m sales of our platelet and plasma systems and sales of IFC, we anticipate that we will
continue to recognize revenue from our government contracts. We recognize government contract revenue associated with the
government contracts as qualifie
f d costs are incurred for
f
reimbursement over the performance period or as a percentage of the overall
contract price based on the extent of progress towards completion.
Fresenius
Fresenius Kabi AG, Fenwal France SAS, and Fenwal International, Inc., or collectively, Fresenius, manufac
f
tures and suppl
u
ies the
platelet and plasma systems to us under our Second Amended and Restated Suppl
u
y and Manufac
f
turing Agreement, or the 2022
Agreement, until December 31, 2031. Fresenius is obligated to sell, and we are obligated to purchase, finished disposable kits for the
platelet and plasma systems. The 2022 Agreement permits us to purchase sets for
f
the platelet and plasma systems fro
f
m third parties to
the extent necessary to maintain suppl
u
y qualific
f ations with such third parties or where local or regional manufact
f
ur
t
ing is needed to
obtain product registrations or sales. The term of the 2022 Agreement will automatically renew for
f
successive two-year periods unless
terminated by either party upon
u
two years’ prior written notice, in the case of the initial term, or one year prior written notice, in the case
of any successive renewal term. Each party has normal and customary t
r
ermination rights, including termination for
f
material breach.
Pricing under the 2022 Agreement for
f
the initial term is based on volume purchases by us and subject to an annual adjustment based on
variation in a price index. For a discussion of the risks presented to our suppl
u
y chain, see “Item 1A—Ri
—
sk
i
Factorsr ” of this Annual Report
on Form 10-K.
See Note 14, Development and License Agre
g
ements, to our audited consolidated financial statements included in Part IV, Item 15,
“Exhibits and Financial Sta
S tement Schedules” of this Annual Report on Form 10-K for
f
further infor
f
mation regarding the 2022
Agreement.
Governm
r
ent contracts
In June 2016, we entered into an agreement with BARDA, or the 2016 BARDA Agreement, to support our development and
implementation of pathogen reduc
d
tion technology for platelet, plasma, and red blood cells, including access to fundi
f
ng that could
potentially suppor
u
t various activities, including conducting studies necessary to suppor
u
t a potential premarket approval appl
a
ication
subm
u
ission to the FDA for the red blood cell system, and accelerating commercial scale up a
u
ctivities to fac
f
ilitate potential adoption of
the red blood cell system by U.S. blood centers.
The 2016 BARDA Agreement provides for
f
the reimbursement of certain amounts incurred by us in connection with our satisfaction of
certain contractua
t
l milestones. Under the 2016 BARDA Agreement, we are reimbursed and recognize revenue as qualifie
f d direct
contract costs are incurred plus capped indirect costs, which permit partial recovery of fringe benefits, overhead and general and
administrative expenses. As of September 30, 2024, BARDA has committed to reimburse certain of our expenses related to the clinical
development of the red blood cell system dur
d
ing a base period, or the 2016 Base Period, and under exercised option periods, or 2016
Option Periods, in an aggregate amount of up to $185.5 million. BARDA will no longer exercise any unexercised options under the
2016 BARDA Agreement.
In September 2024, we entered into a new agreement with BARDA, or the 2024 BARDA Agreement. The 2024 BARDA Agreement
builds on the 2016 BARDA Agreement and aims to fur
f
ther advance the development of the red blood cell system. The 2024 BARDA
Agreement includes access to fundi
f
ng that is intended to support a planned FDA modular premarket appr
a
oval appl
a
ication and potential
post-approval studies, accelerate development of an improved version of the red blood cell system, and scale up c
u
hemistry,
r
manufac
f
turing, and controls activities to enabl
a e a broad product launch, if approved. The six-year agreement with BARDA includes a
base period, or the 2024 Base Period, with committed fun
f
ding of up to $32.1 million, and subsequent option periods, or 2024 Option
Periods, that, if exercised by BARDA and completed, would bring the total funding opportunity of $188.4 million as of September 30,
2024. We could be responsible for cost sharing of up to $60.1 million which we would satisfy by agreeing to utilize lower fringe,
overhead, and G&A rates for select options than we are otherwise allowed to use as suppor
u
ted by audited indirect cost subm
u
issions.
BARDA will make periodic assessments of our progress, and the continuation of the 2024 BARDA Agreement is based on our success
in completing the required tasks under the 2024 Base Period and each 2024 Option Period (if and to the extent any 2024 Option Periods
are exercised by BARDA). BARDA has rights under certain contract clauses to terminate the 2024 BARDA Agreement, including the
ability to terminate for
f
convenience at any time. Under the contract, we will be reimbursed and recognize revenue as qualifie
f d direct
contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of
fringe benefits, overhead and general and administrative expenses. The U.S. Federal Government has imposed a standardized indirect
cost rate on grants administered by the National Institutes of Health. The standardized rates are signific
f antly lower than our current
audited indirect rates. While our contracts with BARDA are not currently impacted by these orders, should the U.S. Federal Government
impose similar restrictions, we would have to abs
a
orb m
r
any of our indirect costs which would adversely affect our operating results. See
Note 14, Developm
o
ent and License Agreements, to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits
and Financial Sta
S tement Schedules” of this Annual Report on Form 10-K for
f
further infor
f
mation regarding our agreements with
BARDA.

66
In September 2020, we entered into a five-year agreement with the FDA for the development of next-generation compounds to optimize
pathogen reduc
d
tion treatment of whole blood to reduce the risk of transfusion-transmitted infect
f
ions. Under the agreement, we are
reimbursed and will recognize revenue as qualifie
f d direct contract costs are incurred plus allowabl
a e indirect costs, based on app
a
roved
provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. The total
contract value is $11.1 million. See Note 14, Development and License Agre
g
ements, to our audited consolidated financial statements
included in Part IV, Item 15, “Exhibits and Financial Sta
S tement Schedules” of this Annual Report on Form 10-K for
f
further information
regarding the agreement with the FDA.
In September 2022, we entered into an agreement with the U.S. Department of Defense, or DoD, for the development of pathogen
reduced, lyophilized cryopr
r
ecipitate to treat bleeding due
d
to trauma. In May 2023, we entered into an amendment to the agreement with
the DoD to extend the agreement to February 2
r
027 and increased the total contract value fro
f
m $9.1 million to $17.8 million. Under the
agreement, we are paid upon
u
completion of each milestone and will recognize revenue based on the application of the cost-to-cost input
method, which measures the extent of progress towards completion based on the ratio of actua
t
l costs incurred to the total estimated
costs. Revenue is recorded as a percentage of the overall contract price based on the extent of progress towards completion. See Note
14, Development and License Agre
g
ements, to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits and
Financial Sta
S tement Schedules” of this Annual Report on Form 10-K for
f
further infor
f
mation regarding the agreement with the DoD.
Equity
i
Agreements
See Note 11, Stockholde
l
rs’ Equity, to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits and Financial
Statement Sch
S
edul
d es” of this Annual Report on Form 10-K for
f
further infor
f
mation regarding the Amended Sales Agreement.
Debt Agreements
See Note 8, Debt,t to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits and Financial Sta
S tement
Schedules” of this Annual Report on Form 10-K for
f
more information on the debt under our Term Loan Credit Agreement and the
Revolving Loan Credit Agreement.
Comparability
This Management’s Discussion and Analysis of Financial Condition and Results of Operations generally discusses December 31, 2024
and December 31, 2023 items and year-to-year comparisons between 2024 and 2023, respectively. Discussions of 2022 items and year-
to-year comparisons between 2023 and 2022 that are not included in this Annual Report on Form 10-K can be found in “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” in Part II Item 7 of our Annual Report on Form 10-K for
f
the fis
f cal year ended December 31, 2023, filed with the SEC on March 5, 2024.
Critical Accounting Policies and Management Estimates
The preparation of financial statements requires us to make estimates, assumptions and judgments that affe
f ct the reported amounts of
assets, liabi
a lities, revenues and expenses, and related disclosures of contingent assets and liabi
a lities. On an ongoing basis, we evaluate
our estimates, including those related to product revenue recognition and government contract revenue. We base our estimates on
historical experience and on various other assumptions that we believe to be reasonabl
a e under the circumstances, the results of which
form our basis for
f
making judgments about the carrying value of assets and liabi
a lities that are not readily appa
a
rent from other sources.
Actual results may differ fro
f
m those estimates under diffe
f rent assumptions or conditions.
We believe the following critical accounting policies require us to make significant judgments and estimates used in the preparation of
our financial statements:
• Revenue—Revenue is recognized in accordance with Accounting Standards Codification (“ASC”) Topic 606, “Revenue from
Contracts with Customers”, by app
a
lying the following five steps: (1) identify t
f
he contract(s) with a customer; (2) identify t
f
he
performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance
obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
The main source of our revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma, or the platelet
and plasma systems or disposable kits, UVA illumination devices, or illuminators, maintenance services of illuminators, and IFC. We
sell the platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in
certain regions. We sell IFC directly to hospital customers in the U.S. using a direct sales for
f
ce and indirectly through certain blood
centers, though we may in the future sell INTERCEPT Blood System for Cryoprecipitation disposable kits to strategic blood centers
that are not manufact
f
ur
t
ing partners for
f
our distribution and sale of IFC. For all sales of our INTERCEPT Blood System produc
d
ts, we
use a binding purchase order or signed sales contract as evidence of a contract and satisfaction of our policy. Generally, our contracts
with customers do not provide for open retur
t
n rights, except within a reasonabl
a e time afte
f r receipt of goods in the case of defec
f
tive or
non-confor
f
ming product. The contracts with customers can include various combinations of products, and to a much lesser extent,
services. In contracts where we sell both products and services, we must determine whether these products or services are capable of
being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. We

67
must allocate the transaction price to each performance obligation on a relative standalone selling price, or SSP basis, and recognize the
revenue when the performance obligation is satisfied. We determine the SSP by using the historical selling price of the produc
d
ts and
services. If the amount of consideration in a contract is variable, we estimate the amount of variable consideration that should be included
in the transaction price. Product revenue is recognized upon
u
transfer
f
of control of promised products or services to customers in an
amount that reflects the consideration that we expect to receive in exchange for those products or services. Product revenue from the
sale of illuminators, disposable kits, spare parts, storage solutions and IFC are recognized upon
u
the transfer of control of the produc
d
ts to
the customer. Product revenue from maintenance services is recognized ratabl
a y on a straight-line basis over the term of maintenance as
customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of produc
d
t
revenue. Taxes invoiced to our customers and remitted to governments are recorded on a net basis, which excludes such tax from product
revenue.
• Government contract revenue—Revenue related to the cost reimbursement provisions under our government contract agreements is
recognized as the allowabl
a e direct contract costs plus allowabl
a e indirect costs are incurred based on approved provisional indirect billing
rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. The U.S. Federal Government has
imposed a standardized indirect cost rate on grants administered by the National Institutes of Health. The standardized rates are
significantly lower than our current audited indirect rates. While our contracts with BARDA are not currently impacted by these orders,
should the U.S. Federal Government impose similar restrictions, we would have to abs
a
orb m
r
any of our indirect costs which would
adversely affect our operating results. Revenue on our milestone-based DoD contract will be recognized on the application of the cost-
to-cost input method, which measures the extent of progress towards completion based on the ratio of actual costs incurred to the total
estimated costs. Revenue is recorded as a percentage of the total contract price based on the extent of progress towards completion.
Direct costs incurred under cost reimbursabl
a e contracts are recorded as research and development expenses or general and administrative
expenses. Payments to us pursuant to our government contract agreements are provisional payments subject to adju
d stment upon audit
by the government. These audits could result in an adjustment to revenue previously reported, which adjustments potentially could be
significant. We believe that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final
audit and settlement. When the final determination of the allowabl
a e costs for any year has been made, revenue and billings may be
adju
d sted accordingly in the period that the adjustment is known.
Results of Operations
Years E
r
nded
d
December 31, 2024, 2023 and 2022
Revenue
Year Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Product revenue
$
180,270
$
156,367
$
162,048
15%
(4%)
Government contract revenue
21,051
30,430
26,267
(31%)
16%
Total revenue
$
201,321
$
186,797
$
188,315
8%
(1%)
Product revenue increased during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to
year-over-year sales volume increase of disposable platelet kit sales to U.S. customers. We expect product revenue for INTERCEPT
disposable kits to increase in fut
f ur
t
e periods driven by growth in our platelet business due
d
in part to increased market acceptance of the
INTERCEPT Blood System and adoption of the INTERCEPT Blood System in geographies where commercialization efforts are
underway.
Government contract revenue decreased during the year ended December 31, 2024, compared to the year ended December 31, 2023,
primarily due to the completion of the ReCePI study
t
in the fir
f st quarter of 2024. We anticipate that for
f
some finite period of time,
government contracts revenue will increase in future periods as multiple contracts are active and as activities supporting those contracts
ramp up.
Cost of Product Revenue
Our cost of product revenue consists of the cost of the INTERCEPT Blood System sold, provisions for obsolete, slow-moving and
unsaleable product, certain order fulfillm
f
ent costs, to the extent applicable and costs for idle faci
f
lities. Inventory i
r
s accounted for on a
first-in, fir
f st-out basis.
Year Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Cost of product revenue
$
80,748
$
69,967
$
74,954
15%
(7%)
Cost of product revenue increased during the year ended December 31, 2024, compared to the year ended December 31, 2023, consistent
with the increase in product revenue for the same comparative periods. We expect cost of product revenue for INTERCEPT disposable
kits to increase in fut
f ur
t
e periods as our product revenue grows.

68
Our gross margin on product sales was 55% during both the years ended December 31, 2024 and December 31, 2023. Margins were
impacted by the mix of geographies into which products were sold, with higher U.S. kit sales over sales in other regions and, to a lesser
extent product mix. Changes in our gross margin on product sales are affected by various factors, including prices of products sold, the
volume of product manufact
f
ur
t
ed, pricing with suppl
u
iers, the timing of inventory p
r
urchases related to the underlying exchange rate of
the Euro relative to the U.S. dollar, manufactur
t
ing and suppl
u
y chain costs, including transportation costs, the mix of product sold, the
mix of customers to which products are sold, and the reserves for
f
excess and obsolete inventory.
r
Furthermore, we may experience cost
pressures due
d
to the current inflationary environment, tariffs and escalating trade tensions, increased transportation costs and adverse
impacts on the efficiency of our suppl
u
y chain. Additionally, we may encounter unfor
f
eseen manufac
f
turing difficulties, which, at a
minimum, may lead to higher than anticipated costs, scrap r
a
ates, delays in manufact
f
ur
t
ing products, or lower production levels of
manufac
f
turing than would be needed to meet demand. We may also decide to make investments with our manufact
f
ur
t
ing partners to
identify longer-term efficiencies, but result in near-term increased costs. To meet the growing demand for our products and to invest in
future quality improvements and gross margin expansion, we have invested in capital equipment, capa
a
city expansion and cost reduction
projects with many of our suppl
u
iers. These projects may cost more than anticipated, may not produce the anticipated benefit
f s or may be
delayed, any of which would potentially limit our expected return on investment and affect our operations. In addition, we may face
f
competition which may limit our ability to maintain existing selling prices for our products which in tur
t
n would negatively affect our
reported gross margins on product sales. Our gross margins on product sales may be impacted in the fut
f ur
t
e based on all of these and
other fac
f
tors.
We expect to build inventory l
r
evels that we believe will be suffic
f ient to meet forecasted demand. At times, we may purchase quantities
of materials, components or fin
f ished products that are expected to be on-hand for longer than one year. We may procure and carry this
inventory t
r
o mitigate obsolescence, suppl
u
y chain disrupt
r
ion and for business continuity reasons.
Research and Developm
l
ent Exp
E
enses
Our research and development expenses include salaries and related expenses for our scientific
f
personnel, non-cash stock-based
compensation, payments to consultants, costs to prepare and conduct preclinical and clinical trials, third-party costs for
f
development
activities, certain regulatory c
r
osts, costs associated with our facility related infra
f structur
t
e, and laboratory c
r
hemicals and suppl
u
ies.
Year Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Research and development
$
58,907
$
67,639
$
64,107
(13%)
6%
Research and development expenses decreased during the year ended December 31, 2024, compared to the year ended December 31,
2023, primarily driven by decreased headcount due to our reduction in for
f
ce implemented in the second quarter of 2023 and the
completion of the ReCePI study
t
in the fir
f st quarter of 2024.
We expect to incur additional research and development costs associated with inflationary pressures on labor and study costs, pursuing
potential regulatory a
r
pp
a
rovals in other geographies where we do not currently sell our platelet and plasma systems, planning and
conducting in vitro studi
t
es and clinical development of our red blood cell system in Europe and the U.S., any activities in support of
any potential new MDR appl
a
ication for
f
our red blood cell system in the EU, new product development and product enhancements,
including potential new labe
a
l claims, design effo
f
rts on our new illuminator, and costs associated with performing the activities under
our government contracts. Due to the inherent uncertainties and risks associated with developing biomedical products, including, but
not limited to, intense and changing government regulation, the impact of macroeconomic developments, including escalating trade
tensions and the ongoing confli
f ct between Ukraine and Rus
R
sia, the uncertainty of future preclinical studi
t
es and clinical trial results and
the uncertainty associated with manufact
f
ur
t
ing, it is not possible to reasonabl
a y estimate the costs to complete these research and
development proje
o cts. We face numerous risks and uncertainties associated with the successful
f
completion of our research and
development proje
o cts, which risks and uncertainties are discussed in fur
f
ther detail under “Item 1A—Ri
—
sk
i
Factorsr ” in Part I of this
Annual Report on Form 10-K.
Selling
i
, G
g
en
G
eral and Administrativ
t e Expe
E
nses
Selling, general and administrative expenses include salaries and related expenses for administrative personnel, non-cash stock-based
compensation, expenses for our commercialization efforts in a number of countries around the world including those in U.S., Europe,
the CIS and the Middle East, Asia, and Latin America, and expenses for accounting, tax, internal control, legal, facility and infra
f structur
t
e
related expenses, and insurance premiums. We expect to incur additional selling, general and administrative costs associated with
inflationary pressures on labor and vendor costs.
Year Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Selling, general and
administrative
$
75,891
$
75,516
$
83,335
0%
(9%)

69
Selling, general, and administrative expenses increased slightly during the year ended December 31, 2024, compared to the year ended
December 31, 2023, primarily driven by non-cash stock-based compensation expense.
Restru
t
cturing
In June 2023, we began implementing a restructur
t
ing plan to pursue greater effi
f ciency and to realign our business and strategic priorities,
which included a reduction in force of our employee base dur
d
ing the second quarter of 2023. The restruc
r
turing also included a facilities
consolidation strategy to cease the use of a part of our corporate office building which occurred dur
d
ing the third quarter of 2023. We
recognized certain charges related to our facilities consolidation. A summary of our restructur
t
ing charges is as follows (in thousands):
ar Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Restructur
t
ing
$
—
$
3,728
$
—
N/A
N/A
See Note 7, Restructuring to our audited consolidated financial statements included in Part IV, Item 15, “Exh
E
ibits a
t
nd Financial
Statement Sch
S
edul
d es” of this Annual Report on Form 10-K for
f
further infor
f
mation regarding the restructur
t
ing charges related to one-
time termination benefits
f
.
Non-Operatin
t
g Expe
E
nse, Net
Non-operating expense, net consists of for
f
eign exchange gains and losses, interest charges incurred on our debt, and other non-operating
gains and losses, including interest earned from our short-term investment portfol
f io, and gains and losses due
d
to changes in the fair value
of certain investments.
Year Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Foreign exchange gain (loss)
$
370
$
(648)
$
(690)
(157%)
(6%)
Interest expense
(8,877)
(8,386)
(5,831)
6%
44%
Other income (expense), net
1,976
1,765
(1,735)
12%
(202%)
Total non-operating expense,
net
$
(6,531)
$
(7,269)
$
(8,256)
(10%)
(12%)
Foreign E
g
xc
E
hange Gai
G n (
i
Lo
(
ss)
We had for
f
eign exchange gain during the year ended December 31, 2024, compared to foreign exchange loss during the year ended
December 31, 2023. These were primarily due to foreign exchange variations between the Euro and the U.S. dollar.
Interest Expe
x
nse
Interest expense increased during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to
the draw down of $5.0 million under Tranche 3 of our Term Loan Credit Agreement in March 2024, and due
d
to the increase in interest
rates on our Term Loan. Should interest rates increase, the rates that we are obligated to pay under our credit agreements would increase,
leading to higher interest expense.
Othe
t
r Inc
I
ome (Ex
(
pe
x
nse), Net
N
Other income, net increased during the year ended December 31, 2024, compared to the year ended December 31, 2023.
Provision for
f
Income Taxe
a
s
Year Ended December 31,
% Change
(in thousands, except percentages)
2024
2023
2022
2024 to 2023
2023 to 2022
Provision for income taxes
$
205
$
325
$
488
(37%)
(33%)
The tax expenses were primarily a result of our Cerus Europe B.V. subs
u
idiary’s activities.
Due to our history o
r
f cumulative operating losses, management has concluded that, afte
f r considering all of the availabl
a e objective
evidence, it is not likely that all our net defer
f red tax assets as of December 31, 2024, will be realized. Accordingly, subs
u
tantially all of
our U.S. deferred tax assets continue to be subj
u ect to a valuation allowance as of December 31, 2024.
Liquidity and Capital Resources
In recent years, our sources of capi
a tal have primarily consisted of public issuance of common stock, debt arrangements and, to a lesser
extent, cash fro
f
m product sales and reimbursements under our government agreements.
As of December 31, 2024 and December 31, 2023, we had the following cash and cash equivalents, short-term investments and restricted
cash (in thousands):

70
December 31, 2024
December 31, 2023
Cash and cash equivalents
$
20,266
$
11,647
Short-term investments
60,186
54,205
Restricted cash
1,095
1,712
Total
$
81,547
$
67,564
Cash is typically invested in highly liquid instrum
r
ents of short-term investments with high-quality credit rated corporate and government
agency fixed-income securities in accordance with our investment policy.
As of December 31, 2024 and December 31, 2023, we had the following indebtedness (in thousands):
December 31, 2024
December 31, 2023
Debt – current
$
19,297
$
20,000
Debt – non-current
64,862
59,796
Total
$
84,159
$
79,796
Operating Activities
Year Ended
(in thousands)
December 31, 2024
December 31, 2023
Net cash provided by (used in) operating activities
$
11,359
$
(43,168)
We had net cash provided by operating activities for
f
the twelve months ended December 31, 2024 compared to net cash used in operating
activities dur
d
ing the same period in 2023. The change was primarily related to the significant reduc
d
tion in our net loss, the decrease in
inventory r
r
elated purchases, and a net increase in cash related to the timing of cash collections and payments, during the twelve months
ended December 31, 2024, compared to the same period in 2023.
Investing Activities
Year Ended
(in thousands)
December 31, 2024
December 31, 2023
Net cash (used in) provided by investing activities
$
(8,130)
$
8,624
We had net cash used in investing activities for
f
the twelve months ended December 31, 2024 compared to net cash provided by investing
activities dur
d
ing the same period in 2023. The change was primarily due to higher purchases of investments offset by higher proceeds
from the maturity and sale of our investments dur
d
ing the twelve months ended December 31, 2024, compared to the same period in
2023.
Financing Activities
Year Ended
(in thousands)
December 31, 2024
December 31, 2023
Net cash provided by fin
f ancing activities
$
4,964
$
10,673
The decrease in net cash provided by fin
f ancing activities for
f
the twelve months ended December 31, 2024 was primarily due to payments
related to the Revolving Loan Credit Agreement dur
d
ing the twelve months ended December 31, 2024 compared to proceeds from the
Revolving Loan Credit Agreement dur
d
ing the twelve months ended December 31, 2023. See Note 8, Debt,t to our audited consolidated
financial statements included in Part IV, Item 15 “Exh
E
ibits a
t
nd Financial Sta
S tement Schedules” of this Annual Report on Form 10-K
for more infor
f
mation.
Working Capi
C
tal
(in thousands)
December 31, 2024
December 31, 2023
Working capital
$
88,890
$
78,392
Working capital increased as of December 31, 2024, compared to December 31, 2023, primarily due to proceeds from increased product
sales, collections, and increase in short-term investments and decrease in our accounts payable as a result of the timing of payments to
our vendors. Contract liabilities related to DoD of $0.5 million and $1.5 million as of December 31, 2024 and December 31, 2023,
respectively, are excluded fro
f
m working capital.
Capi
a tal Requirementst

71
Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments
associated with developing and commercializing the INTERCEPT Blood System, including in connection with the continuing U.S.
commercialization of our platelet, plasma systems and IFC, costs to develop diffe
f rent config
f urations of existing product candidates and
products, costs associated with the development of new produc
d
ts, including our illuminator, costs associated with planning, enrolling
and completing ongoing clinical and non-clinical studi
t
es, including the post-approval studies or registry studi
t
es we are and may be
required to conduc
d
t in connection with the appr
a
ovals of the platelet system, costs associated with pursuing potential regulatory a
r
ppr
a
ovals
in other geographies where we do not currently sell our platelet and plasma systems, costs associated with planning and conducting in
vitro studi
t
es and clinical development of our red blood cell system in Europe and the U.S., costs associated with performing the agreed-
upon activities under our government agreements, costs related to legal compliance, and costs related to creating, maintaining and
defending our intellectua
t
l property. In addition, both our near and long-term capital requirements will require that we continue to invest
in capi
a tal purchases to suppor
u
t ongoing and proposed studi
t
es, in addition to manufact
f
ur
t
ing capacity expansion to support our growing
business. Our long-term capital requirements will also be dependent on the success of our sales efforts, competitive developments, the
timing, costs and magnitude of our longer-term clinical trials and other development activities, required post-approval studies, market
preparedness and product launch activities for
f
any of our produc
d
t candidates and products in geographies where we do not currently sell
our products, and regulatory f
r
act
f
ors. While we have recently been able to generate a suffi
f cient amount of revenue and generate positive
net cash flo
f ws from operations, we may be unabl
a e to sustain those results in the fut
f ur
t
e. If we are unabl
a e to continue to produce positive
operating cash flo
f ws or at sufficient levels, meeting our long-term capi
a tal requirements is in large part reliant on continued access to
funds under our government contracts and the public and private equity and debt capital markets, as well as on collabor
a
ative
arrangements with partners, augmented by cash generated from operations, if at all, and interest income earned on the investment of our
cash balances. We believe that our availabl
a e cash and cash equivalents and short-term investments, as well as cash received from
f
product
sales and under our government contracts, will be suffic
f ient to meet our capital requirements for
f
at least the next 12 months. However,
if we are unabl
a e to generate suffi
f cient product revenue, or access suffi
f cient funds
f
under our government contracts or the public and
private equity and debt capital markets, we may be unabl
a e to execute successful
f ly on our operating plan. We have based our cash
sufficiency estimate on assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, including inflationary
assumptions, we could consume our availabl
a e capital resources sooner than we currently expect or in excess of amounts than we currently
expect, which could adversely affect our commercialization and clinical development activities. In addition, while our stated goal is to
achieve profita
f
bi
a lity in the fut
f ur
t
e, actual results may be different than our forecasted operating plan and may require that we take certain
actions to potentially achieve profitabi
a lity, which may negatively impact our commercial potential or result in defer
f rals in development
activities.
We have borrowed and in the fut
f ur
t
e may borrow additional capital fro
f
m institutional and commercial banking sources to fund fut
f ur
t
e
growth, including pursuant to the Term Loan Credit Agreement and Revolving Loan Credit Agreement, or potentially pursuant to new
arrangements with different lenders. We have borrowed and in the fut
f ur
t
e may borrow funds
f
on terms that may include restrictive
covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, fin
f ancial
performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets. In addition,
unless we restruc
r
ture our credit agreements prior to April 1, 2026, or qualify f
f
or
f
and exercise our option to delay amortization to April
1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will
require us to pay amounts as they come due
d
in cash, which would negatively impact our availabl
a e working capital beyond the next 12
months. Should interest rates increase again, the rates that we are obligated to pay under our credit agreements would increase, leading
to higher interest expense. See Note 8, Debt, to our audited consolidated financial statements included in Part IV, Item 15—Ex
—
hibits
and Financial Sta
S tement Schedules of this Annual Report on Form 10-K for
f
more information on the debt under our Term Loan Credit
Agreement and the Revolving Loan Credit Agreement.
In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development effort
f
s and
operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience subs
u
tantial
dilution. To the extent that we raise additional funds
f
through collabor
a
ation or partnering arrangements, we may be required to relinquish
some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are
not favorable to us, or issue equity that may be substantially dilutive to our stockholders. Moreover, recent developments in the fin
f ancial
services industry c
r
ould cause us to experience liquidity constraints or fai
f lures, hinder our ability to perform obligations under various
types of fin
f ancial, credit or liquidity agreements or arrangements, and result in fur
f
ther disrupt
r
ions or instability in the fin
f ancial services
industry o
r
r fin
f ancial markets. In addition, widespread investor concerns regarding the U.S. or international fin
f ancial systems could result
in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or
systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptabl
a e
terms or at all. Any decline in availabl
a e fundi
f
ng or access to our cash and liquidity resources could, among other risks, adversely impact
our ability to meet our operating expenses, fin
f ancial obligations or fulfill
f
our other obligations, result in breaches of our financial and/or
contractua
t
l obligations or result in violations of federal or state wage and hour laws. Any of these impacts, or any other impacts resulting
from the factors described above or other related or similar factors not described above
a
, could have material adverse impacts on our
liquidity and our current and/or projected business operations and fin
f ancial condition and results of operations.

72
In March 2023, we entered into an amendment to our Sales Agreement under which we may issue and sell up t
u
o $96.8 million of our
common stock through or to Cantor Fitzgerald & Co. or Stifel
f , Nicolaus & Company, Incorporated, as sales agent or principal. During
the year ended December 31, 2024, we did not sell shares of our common stock under the Amended Sales Agreement.
While we expect to receive significant fundi
f
ng under our agreements with BARDA, our ability to obtain the funding we expect to
receive under both agreements is subj
u ect to various risks and uncertainties, including with respect to BARDA’s abi
a lity to terminate the
agreements for convenience at any time and our ability to achieve the required milestones under the agreements, including the
completion of the RedeS study. In addition, access to fed
f
eral contracts is subject to the authorization of funds
f
and appr
a
oval of our
research plans by various organizations within the fed
f
eral government, including the U.S. Congress. The general economic environment,
coupled with tight federal budgets, has led to a general decline in the amount availabl
a e for
f
government funding. If BARDA were to
eliminate, reduce or delay funding under our agreements, this would have a significant negative impact on the programs associated with
such funding and could have a significant negative impact on our revenues and cash flo
f ws. Furthermore, should we be unabl
a e to deploy
personnel or derive a benefit
f
from fix
f ed study
t
costs or generate data fro
f
m clinical sites and studi
t
es reimbursed by BARDA, our cash
flows would be negatively impacted or we may have to initiate furloughs and layoffs
f
which would likely prove disrup
r
tive to our
management and operations. In addition, if we are unabl
a e to meet the requisite milestones in our agreements, including generating
sufficient prerequisite Phase 3 clinical data, our agreements with BARDA will be severely limited in scope or could be terminated
altogether, and our ability to complete the development activities required for
f
licensure in the U.S. may require additional capital beyond
which we currently have. The availabi
a lity and foc
f
us for any BARDA fundi
f
ng will likely be fin
f ite and may require us to compete with
other technologies, both similar and disparate. If alternative sources of funding are not availabl
a e, or if we determine that the cost of
alternative availabl
a e capital is too high, we may be for
f
ced to suspend or terminate development activities related to the red blood cell
system in the U.S.
We do not currently enter into any hedging contracts to normalize the impact of foreign exchange fluctuations. As a result, our future
results could be materially affect
f
ed by changes in these or other fact
f
ors.
As a result of economic conditions, general global economic uncertainty, political change, war, the effe
f cts of infla
f tionary pressures,
tariffs and escalating trade tensions, and other fact
f
ors including past and potential fut
f ur
t
e U.S. bank fai
f lures, we do not know whether
additional capital will be availabl
a e when needed, or that, if availabl
a e, whether we will be able to obtain additional capital on reasonabl
a e
terms. Specifically, monetary policies of many countries, as well as recent bank fai
f lures, have significantly disrupt
r
ed global fin
f ancial
markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity. As a result of stimulus
programs and global events over the past few years, the U.S. and many countries are currently experiencing an inflationary environment.
In addition, the U.S. Federal Reserve has raised, and may again raise, interest rates, in response to concerns about inflation. Moreover,
the U.S. Federal Reserve may not lower interest rates as quickly as markets expect, if at all, which in turn could negatively impact equity
values, including the value of our common stock. Furthermore, we expect that the costs of our business may increase as labor rates and
prices rise in the current inflationary environment, transportation costs increase, and global supply chain constraints impact availabi
a lity
of our products. We may not be able to offs
f et prices increases fro
f
m vendors with price increases to customers at suffi
f cient levels, if at
all, which would harm our results of operations. If we are unabl
a e to raise additional capital due
d
to the volatile global fin
f ancial markets,
general economic uncertainty or other fact
f
ors, we may need to curtail planned development or commercialization activities.
In addition, we may need to obtain additional funds
f
to complete development activities for
f
the red blood cell system necessary for CE
Certific
f ates of Confor
f
mity in the EU, if costs are higher than anticipated or we encounter further delays. In this regard, our product
development costs will be ongoing in connection with our failure to obtain appr
a
oval of our MDR appl
a
ication and the potential submission
of a new MDR appl
a
ication and would also increase if existing clinical data is insufficient for
f
us to either subm
u
it or potentially obtain
approval of any such new appl
a
ication. We may need to obtain additional fundi
f
ng to conduct additional randomized controlled clinical
trials for existing or new products, particularly if we are unabl
a e to access any additional portions of the fundi
f
ng contemplated by our
government contracts, and we may choose to defer
f
such activities until we can obtain suffi
f cient additional fundi
f
ng or, at such time, our
existing operations provide sufficient cash flo
f w to conduct these trials.
Commitments
See Note 8, Debt,t to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits and Financial Sta
S tement
Schedules” of this Annual Report on Form 10-K for
f
more information on the debt under our Term Loan Credit Agreement and the
Revolving Loan Credit Agreement.
See Note 10, Commitments and Contingencies, to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits
and Financial Sta
S tement Schedules” of this Annual Report on Form 10-K for
f
more information on the operating leases and purchase
commitments.
We did not have any off-b
f
alance sheet arrangements as of December 31, 2024.

73
Financial Instruments
Our investment policy is to manage our marketable securities portfol
f io to preserve principal and liquidity while maximizing the return
on the investment portfol
f io to assist us in funding our operations. We currently invest our cash and cash equivalents in money market
funds and interest-bearing accounts with fin
f ancial institutions. Our money market funds
f
are classifie
f d as Level 1 in the fair value
hierarchy, in which quoted prices are availabl
a e in active markets, as the maturity of money market funds
f
are relatively short and the
carrying amount is a reasonabl
a e estimate of fair value. Our available-for
f
-sale securities related to corporate debt and U.S. government
agency securities are classified as Level 2 in the fai
f r value hierarchy, which uses observabl
a e inputs to quoted market prices, benchmark
yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonabl
a e levels of price transparency. We maintain
portfol
f io liquidity by ensuring that the securities have active secondary or resale markets. We did not record any credit losses dur
d
ing the
years ended December 31, 2024, 2023 and 2022. Adverse global economic conditions have had, and may continue to have, a negative
impact on the market values of potential investments.

74
Item 7A. Quantita
i tive and Qualita
l
tive Disc
i
losures about Mar
M
ke
r
t Risk
Interest Rate Risk
At December 31, 2024, we held cash, cash equivalents, short-term investments and investments in marketabl
a e equity securities of $80.5
million. We do not believe our exposure to interest rate risk to be material given we held cash in interest-bearing accounts with fin
f ancial
institut
t ions and the short-term nature of our investment portfol
f io consisted of highly liquid money market instrum
r
ents and corpor
r
ate
debt and U.S. government agency securities with short-term maturities. The weighted average interest rate of our cash and cash
equivalents at December 31, 2024, was 4.4%.
Our exposure to market rate risk for
f
changes in interest rates relates primarily to our money market instrum
r
ents, corpor
r
ate debt securities
and the amounts borrowed pursuant to the Term Loan Credit Agreement and Revolving Loan Credit Agreement. We do not use
derivative financial instrum
r
ents. By policy, we may place investments with high quality debt security issuers, limit the amount of credit
exposure to any one issuer and limit duration by restricting the term for single securities and for
f
the portfol
f io as a whole. Our investments
are held and managed by a third-party capital management adviser that in tur
t
n, utilizes a combination of active market quotes and where
necessary, proprietary pricing models as well as a subscribed pricing service, in order to estimate fair value. While we believe that we
will be able to recognize the fai
f r value of our money market instrum
r
ents when they mature or are sold, or if we purchase investments in
securities in the fut
f ur
t
e, there can be no assurance that the markets for
f
these securities will not deteriorate fur
f
ther or that the institutions
that these securities are with will be able to meet their debt obligations.
With respect to the Term Loan Credit Agreement and Revolving Loan Credit Agreement, we are exposed to risks associated with
changes in interest rates in connection with our related borrowings. Based on our indebtedness under the Term Loan Credit Agreement
of $65.0 million and Revolving Loan Credit Agreement of $19.3 million as of December 31, 2024, and the interest rate on such
borrowings then in effe
f ct, a hypothetical 100 basis point increase in interest rates could increase our net interest expense in 2024 by
approximately $0.8 million subject to certain limitations in each agreement.
Foreign Currency Risk
Our international operations are subject to risks typical of an international business, including, among other fac
f
tors: diffe
f ring political,
economic, and regulatory c
r
limates, different tax struc
r
tures, and for
f
eign exchange volatility. We do not currently enter into any hedging
contracts to normalize the impact of foreign exchange flu
f ctua
t
tions. As a result, our future results could be materially impacted by
changes in these or other fact
f
ors.
Product sales for our blood safety products are predominantly made in Europe and generally are invoiced to customers in Euro. In
addition, we incur operating expenses, including payment for
f
finished goods inventory o
r
f disposable kits for the platelet and plasma
systems. These inventory p
r
urchases and operating expenses are generally paid in Euro and, to a much lesser degree, other for
f
eign
currencies. Our exposure to foreign exchange rate volatility is a direct result of our product sales, cash collection and expenses to suppor
u
t
our international operations. Foreign exchange rate fluctuations are recorded as a component of non-operating expense, net on our
consolidated statements of operations. Significant flu
f ctua
t
tions in the volatility of foreign currencies relative to the United States dollar
may materially impact our results of operations. An unfavorable 10% change in foreign currency exchange rates for
f
our cash, accounts
receivabl
a e, accounts payable and accrued liabi
a lities that are denominated in foreign currencies at December 31, 2024, would have
negatively impacted our annual fin
f ancial results by $1.0 million. Currently we do not have any near-term plans to enter into a for
f
mal
hedging program to mitigate the effe
f cts of for
f
eign currency volatility.
Item 8. Fina
i
ncial Sta
S tements a
t
nd Suppl
u
em
l
entary Data
Our consolidated financial statements, together with related notes and report of Ernst & Young LLP, independent registered public
accounting fir
f m, are listed in Item 15(a) and included herein.
Item 9. Changes in a
i
nd Disa
i
gr
a
eements with
i
Accountan
t
ts on Accountin
t
g and Fina
i
ncial Disclos
l
ure
None.

75
Item 9A. Contro
t
ls and Pro
P
cedures
Evaluation of Disc
i
losure Contro
t
ls and Pro
P
cedures
Our management, with the participation of our chief executive officer, or CEO, and chief fin
f ancial offi
f cer, or CFO, has evaluated the
effe
f ctiveness of our disclosure controls and procedur
d
es (as defin
f ed in Exchange Act, Rule 13a–15(
a
e) and 15d-15(e)), as of the end of
the period covered by this Annual Report on Form 10-K. Based on such evaluation, our CEO and CFO have concluded that as of
December 31, 2024, our disclosure controls and procedur
d
es are effective to provide reasonabl
a e assurance that information we are
required to disclose in reports that we file or subm
u
it under the Exchange Act is recorded, processed, summarized, and reported within
the time periods specifie
f d in the rules and forms of the Securities and Exchange Commission, or SEC, and that such inform
f
ation is
accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding
required disclosure.
Limi
i
ta
i tions on the Effe
E
ctiv
t eness of C
o
on
C
trolsl
In designing and evaluating the disclosure controls and procedur
d
es and internal control over fin
f ancial reporting, management recognizes
that any controls and procedur
d
es, no matter how well designed and operated, can provide only reasonabl
a e assurance of achieving the
desired control objectives. In addition, the design of disclosure controls and procedur
d
es and internal control over fin
f ancial reporting
must reflect the fact
f
that there are resource constraints and that management is required to appl
a
y judgment in evaluating the benefits of
possible controls and procedur
d
es relative to their costs.
Manage
a
ment’s Repor
e
t on Int
I
er
t
nal Con
C
trol over Fina
i
ncial Reporting
i
Our management is responsible for establishing and maintaining adequate internal control over fin
f ancial reporting (as defin
f ed in Rule
13a-15(f) under the Exchange Act). Management conducted an assessment of the effe
f ctiveness of our internal control over fin
f ancial
reporting based on the criteria set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (2013 framework). Based on the assessment, management has concluded that our internal
control over fin
f ancial reporting was effe
f ctive as of December 31, 2024, to provide reasonabl
a e assurance regarding the reliabi
a lity of
financial reporting and the preparation of fin
f ancial statements in accordance with U.S. Generally Accepted Accounting Principles. Our
independent registered public accounting fir
f m that audited the fin
f ancial statements included in this Annual Report on Form 10-K, Ernst
& Young LLP, has issued an audit report with respect to our internal control over fin
f ancial reporting, which is included below.
Changes in I
i
nt
I
er
t
nal Con
C
trol over Fina
i
ncial Reporting
There were no changes in our internal control over fin
f ancial reporting identifie
f d in management’s evaluation pursuant to Rul
R es 13a-
15(d) and 15d-15(d) of the Exchange Act which occurred dur
d
ing our fiscal quarter ended December 31, 2024, which have materially
affe
f cted, or are reasonabl
a y likely to materially affect
f
, our internal control over fin
f ancial reporting.

76
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Cerus Corpor
r
ation
Opinion on Internal Control over Financial Reporting
We have audited Cerus
r
Corporation’s internal control over fin
f ancial reporting as of December 31, 2024, based on criteria established in
Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013
framework) (the COSO criteria). In our opinion, Cerus Corpo
r
ration (the Company) maintained, in all material respects, effe
f ctive internal
control over fin
f ancial reporting as of December 31, 2024, based on the COSO criteria.
We also have audited, in accordance with the standards of the Publ
u ic Company Accounting Oversight Board (United States) (PCAOB),
the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations,
comprehensive loss, stockholders’ equity and cash flo
f ws for each of the three years in the period ended December 31, 2024, and the
related notes and our report dated Februa
r
ry 26, 2025 expressed an unqualifie
f d opinion thereon.
Basis for
f
Opinion
The Company's management is responsible for maintaining effe
f ctive internal control over fin
f ancial reporting and for its assessment of
the effectiveness of internal control over fin
f ancial reporting included in the accompanying Management’s Report on Internal Control
over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over fin
f ancial reporting based
on our audit. We are a public accounting fir
f m registered with the PCAOB and are required to be independent with respect to the Company
in accordance with the U.S. fed
f
eral securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to
obtain reasonabl
a e assurance about whether effective internal control over fin
f ancial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over fin
f ancial reporting, assessing the risk that a material weakness
exists, testing and evaluating the design and operating effe
f ctiveness of internal control based on the assessed risk, and performing such
other procedur
d
es as we considered necessary in the circumstances. We believe that our audit provides a reasonabl
a e basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over fin
f ancial reporting is a process designed to provide reasonabl
a e assurance regarding the reliabi
a lity of
financial reporting and the preparation of fin
f ancial statements for external purpos
r
es in accordance with generally accepted accounting
principles. A company’s internal control over fin
f ancial reporting includes those policies and procedur
d
es that (1) pertain to the
maintenance of records that, in reasonabl
a e detail, accurately and fai
f rly refle
f ct the transactions and dispositions of the assets of the
company; (2) provide reasonabl
a e assurance that transactions are recorded as necessary to permit preparation of fin
f ancial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonabl
a e assurance regarding prevention
or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effe
f ct on the
financial statements.
Because of its inherent limitations, internal control over fin
f ancial reporting may not prevent or detect misstatements. Also, proje
o ctions
of any evaluation of effectiveness to fut
f ur
t
e periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedur
d
es may deteriorate.
/s/ Ernst & Young LLP
San Mateo, Califor
f
nia
Februa
r
ry 26, 2025

77
Item 9B. Othe
t
r Inf
I
or
f
ma
r
tion
On November 14, 2024, Richard Benja
n min, Chief Medical Offi
f cer, adopted a Rul
R e 10b5-1 trading arrangement that is intended to satisfy
the affirmative defen
f
se conditions of rule 10b5-1(c) for the sale of up to 85,301 shares of the Company’s stock until November 14, 2025.
On November 15, 2024, Kevin Green, Chief Financial Offic
f er, adopted a Rul
R e 10b5-1 trading arrangement that is intended to satisfy
the affirmative defen
f
se conditions of rule 10b5-1(c) for the sale of up to 60,656 shares of the Company’s stock until May 15, 2025.
Item 9C. Disc
i
losure Regar
e
ding
i
Foreign J
g
ur
J
isdictio
t ns that Prevent Ins
I
pe
s
ctio
t ns
Not appl
a
icable.

78
PART III
Certain infor
f
mation required by Part III is omitted fro
f
m this Annual Report on Form 10-K since we intend to file our definitive proxy
statement for
f
our 2025 annual meeting of stockholders, or the Proxy Statement, pursuant to Regulation 14A of the Securities Exchange
Act of 1934, as amended, not later than 120 days afte
f r the end of the fiscal year covered by this Annual Report on Form 10-K, and
certain information to be included in the proxy statement is incorpor
r
ated herein by reference.
Item 10. Dire
i
ctor
t
s,
r
Executive Offi
O
cers a
r
nd Corporate G
t
ov
G
ernance
The infor
f
mation required by this item is to be included in our Proxy Statement as follows:
•
The infor
f
mation relating to our executive officers is to be included in the section entitled “Executive Officers;”
•
The info
f rmation relating to our directors and nominees for directors is to be included in the section entitled “Proposal No.
1—Election of Directors;”
•
The infor
f
mation relating to our audit committee and audit committee fin
f ancial expert is to be included in the section entitled
“Infor
f
mation Regarding the Board of Directors and Corporate Governance;”
•
The infor
f
mation relating to our insider trading policies and procedur
d
es is to be included in the section entitled “Information
Regarding the Board of Directors and Corpo
r
rate Governance–Insider Trading Policy;” and
•
If required, the infor
f
mation regarding compliance with Section 16(a) of the Securities Exchange Act of 1934, as amended,
is to be included in the section entitled “Delinquent Section 16(a) Reports.”
Such information will be included in the Proxy Statement and is incorporated herein by reference.
Code of Ethics
We have adopted the Cerus
r
Corporation Code of Business Conduct and Ethics, or Ethics Code, that appl
a
ies to all of our offi
f cers, directors
and employees. The Ethics Code is availabl
a e on our website at www.cerus
r
.com on the “Corporate Governance” page of the section titled
“Investors.” If we make any subs
u
tantive amendments to the Ethics Code or grant any waiver from a provision of the Ethics Code to any
executive offi
f cer or director, we intend to promptly disclose the natur
t
e of the amendment or waiver as required by appl
a
icable laws. To
satisfy our disclosure requirements, we plan to post any waivers of or amendments to the Ethics Code on our website in lieu of filin
f
g
such waivers or amendments on a Form 8-K.
Our employees are required to report any conduct that they believe in good faith to be an actua
t
l or appa
a
rent violation of the Ethics Code.
The Audit Committee of our Board of Directors has establ
a ished procedur
d
es to receive, retain and address complaints regarding
accounting, internal accounting controls or auditing matters and to allow for
f
the confid
f ential and anonymous subm
u
ission by employees
of related concerns.
Item 11. Executive Com
C
pe
m
nsatio
t n
The infor
f
mation required by this item is to be included in our Proxy Statement under the sections entitled “Executive Compensation,”
“Director Compensation,” “Infor
f
mation Regarding the Board of Directors and Corpor
r
ate Governance—Infor
f
mation Regarding
Committees of the Board of Directors—Compensation Committee Interlocks and Insider Participation” and “Information Regarding the
Board of Directors and Corpo
r
rate Governance—Infor
f
mation Regarding Committees of the Board of Directors—Compensation
Committee Report” and is incorpo
r
rated herein by refer
f ence.
Item 12. Security
i
Ownership of Certai
t n B
i
enefic
f ial Owners a
r
nd Manage
a
ment and Relat
l ed
t
Stoc
t
kholde
l
r Mat
M te
t rs
The infor
f
mation required by this item with respect to equity compensation plans is to be included in our Proxy Statement under the
section entitled “Securities Authorized for Issuance Under Equity Compensation Plans—Equity Compensation Plan Infor
f
mation” and
the infor
f
mation required by this item with respect to security ownership of certain beneficial owners and management is to be included
in our Proxy Statement under the section entitled “Security Ownership of Certain Benefic
f ial Owners and Management” and in each case
is incorporated herein by refer
f ence.

79
Item 13. Certai
t n R
i
elat
l io
t nships
i
and Relat
l ed
t
Transactio
t ns, a
s
nd Dire
i
ctor
t
Indepe
e
nden
d
ce
The infor
f
mation required by this item is to be included in our Proxy Statement under the sections entitled “Transactions with Related
Persons” and “Infor
f
mation Regarding the Board of Directors and Corporate Governance—Independence of the Board of Directors” and
is incorporated herein by reference.
Item 14. Principal
i
Accountant Fees and Ser
S
vices
The infor
f
mation required by this item is to be included in our Proxy Statement under the section entitled “Proposal 4— Ratific
f ation of
Selection of Independent Registered Publ
u ic Accounting Firm” and is incorpor
r
ated herein by reference.

80
PART IV
Item
t
15. Exhibits
i
and Fin
F
ancial Stat
t em
t
ent Sch
S
edules
l
The fol
f lowing documents are being filed as part of this Annual Report on Form 10-K:
(a)
The fol
f lowing documents are being filed as part of t
o
his A
i
nnual Repor
e
t on For
F
m 10-K:
(1) Financial Statements.
( )
Page
Report of Ernst & Young LLP, Independent Registered Publ
u ic Accounting Firm (PCAOB ID: 42) ..........................................
86
Consolidated Balance Sheets .......................................................................................................................................................
88
Consolidated Statements of Operations ........................................................................................................................................
89
Consolidated Statements of Comprehensive Loss .......................................................................................................................
90
Consolidated Statements of Stockholders’ Equity .......................................................................................................................
91
Consolidated Statements of Cash Flows ......................................................................................................................................
92
Notes to Consolidated Financial Statements .................................................................................................................................
93
(2) Financial Statement Schedul
d es.
( )
Financial statement schedules have been omitted in this Annual Report because they are not applicable, not required under the
instructions, or the information requested is set for
f
th in the fin
f ancial statements or related notes thereto.
(3) Exhibits
( )
Exhibit Number
Description of Exhibit
3.1(7)
Amended and Restated Certific
f ate of Incorpor
r
ation of Cerus
r
Corporation.
3.2(7)
Certific
f ate of Amendment to the Amended and Restated Certific
f ate of Incorpor
r
ation of Cerus
r
Corporation.
3.3(9)
Certific
f ate of Amendment to the Amended and Restated Certific
f ate of Incorpor
r
ation of Cerus
r
Corporation.
3.4(20)
Certific
f ate of Amendment to the Amended and Restated Certific
f ate of Incorpor
r
ation of Cerus
r
Corporation.
3.5(26)
Amended and Restated Bylaws of Cerus Corpo
r
ration.
4.1(1)
Specimen Stock Certific
f ate.
4.2(27)
Description of securities registered under Section 12 of the Exchange Act of 1934.
Suppl
p y a
l
nd/o
d r Man
M
ufac
f
turing
i
Agreements
10.1(27)††
Amended and Restated Suppl
u
y Agreement, dated April 21, 2014, by and between Cerus Corpor
r
ation and Purolite
Corporation.
10.2(19)
First Amendment to Amended and Restated Supply Agreement, dated December 1, 2020, by and between Cerus
Corporation and Purolite Corporation.
10.3††
Second Amended and Restated Suppl
u
y and Manufact
f
ur
t
ing Agreement, dated December 9, 2024, by and between Cerus
Corporation and Porex Corpor
r
ation.
10.4(27)††
Amended and Restated Suppl
u
y Agreement, dated as of September 1, 2011, between Cerus Corpor
r
ation and Ash Stevens
Inc.
10.5(21) ††
Second Amended and Restated Manufactur
t
ing and Suppl
u
y Agreement, by and between Cerus Corpor
r
ation and Fresenius
Kabi
a
AG, Fenwal France SAS, and Fenwal International, Inc, effe
f ctive as of January 1, 2022.
Loan and Sec
S
urity Agreements

81
10.6(22)††
Amended and Restated Credit, Security and Guaranty Agreement (Term Loan), dated March 31, 2023, by and among
Cerus Corpor
r
ation, the lenders party thereto and MidCap F
a
inancial Trus
r
t.
10.7(27)††
Amendment No. 1 to Amended and Restated Credit, Security and Guaranty Agreement (Term Loan), dated September
1, 2023, by and among Cerus Corpor
r
ation, the lenders party thereto and MidCap F
a
inancial Trus
r
t.
10.8(27)††
Amendment No. 2 to Amended and Restated Credit, Security and Guaranty Agreement (Term Loan), dated January 5,
2024, by and among Cerus Corpor
r
ation, the lenders party thereto and MidCap F
a
inancial Trus
r
t.
10.9(22) ††
Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan), dated March 31, 2023, by and
among Cerus Corpor
r
ation, the lenders party thereto and MidCap F
a
inancial IV Trus
r
t.
10.10†(27)† Amendment No. 1 to Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan), dated January
5, 2024, by and among Cerus Corpor
r
ation, the lenders party thereto and MidCap F
a
inancial IV Trus
r
t.
Real Estate Lease Agreements
10.11(13) †
Lease, dated February 1
r
6, 2018, between Cerus
r
Corporation and 1200 Concord LLC.
10.12(14)
First Amendment to Lease, dated May 11, 2018, between Cerus Corpor
r
ation and 1200 Concord LLC.
10.13(15)
Second Amendment to Lease, dated August 10, 2018, between Cerus Corpor
r
ation and 1200 Concord LLC.
10.14(16)
Third Amendment to Lease, dated October 5, 2018, between Cerus Corpor
r
ation and 1200 Concord LLC.
10.15(16)
Fourth Amendment to Lease, dated November 30, 2018, between Cerus
r
Corporation and 1200 Concord LLC.
Empl
m oy
l
ment Agreements or Offe
f r Lette
t rs
10.16(5)*
Employment Letter, by and between Cerus Corpor
r
ation and William M. Greenman, dated May 12, 2011.
10.17(8)*
Addendum to Employment Agreement for William M. Greenman, dated December 5, 2012.
10.18(14)*
Amendment to Employment Letter, by and between Cerus Corpor
r
ation and William M. Greenman, dated April 17, 2018.
10.19(4)*
Employment Letter for
f
Kevin D. Green, dated May 1, 2009.
10.20(14)*
Amendment to Employment Letter, by and between Cerus Corpor
r
ation and Kevin Green, dated April 17, 2018.
10.21(8)*
Employment Letter, by and between Cerus Corpor
r
ation and Chrystal Menard, dated October 19, 2012.
10.22(10)*
Employment Letter, by and between Cerus Corpor
r
ation and Richard J. Benja
n min MBChB, PhD, FRCPath, dated May
12, 2015.
10.23(12)*
Employment Letter, by and between Cerus Corpor
r
ation and Vivek Jayaraman, dated May 31, 2016.
Stoc
t
k Pla
P ns and Relat
l ed
t
Forms
10.24(28)*
Amended and Restated 1996 Employee Stock Purchase Plan, effective June 3, 2020.
10.25(24)*
Amended and Restated 2008 Equity Incentive Plan, effe
f ctive June 7, 2023.
10.26(6)*
Form of Option Agreement for
f
employees under the Amended and Restated 2008 Equity Incentive Plan.
10.27(6)*
Form of Option Agreement for
f
non-employee directors under the Amended and Restated 2008 Equity Incentive Plan.

82
10.28(6)*
Form of Restricted Stock Unit Agreement under the Amended and Restated 2008 Equity Incentive Plan.
10.29(11)*
Cerus
r
Corporation Inducement Plan.
10.30(11)*
Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Cerus Corpor
r
ation Inducement
Plan.
10.31(11)*
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under the Cerus Corpo
r
ration
Inducement Plan.
10.32(14)*
Form of Restricted Stock Unit Agreement under the Amended and Restated 2008 Equity Incentive Plan, amended as of
April 17, 2018.
10.33(14)*
Form of Restricted Stock Unit Agreement for
f
Non-Employee Directors under the Amended and Restated 2008 Equity
Incentive Plan, amended as of April 17, 2018.
10.34(28)*
Cerus
r
Corporation 2024 Equity Incentive Plan.
10.35(28)*
Form of Restricted Stock Unit Agreement for
f
Non-Employee Directors under the 2024 Equity Incentive Plan.
Othe
t
r Com
C
pe
m
nsator
t
y P
r
la
P ns or Agreements
10.36(8)*
Bonus Plan for Senior Management of Cerus
r
Corporation, as amended December 5, 2012.
10.37(14)*
Cerus
r
Corporation Change of Control Severance Benefit Plan, amended as of April 17, 2018.
10.38(3)*
Form of Severance Benefits Agreement.
10.39(28)*
Amended and Restated Non-Employee Director Compensation Policy, effe
f ctive June 4, 2024.
10.40(17)*
Nonqualifie
f d Plan Service and Expense Agreement, by and between Cerus Corpor
r
ation and Principal Life I
f
nsurance
Company, dated May 21, 2020.
10.41(17)*
The Executive Nonqualified Excess Plan Adoption Agreement, dated May 21, 2020.
Othe
t
r Mat
M er
t
ial Agreements
10.42(1)
Form of Indemnity Agreement entered into between Cerus Corpor
r
ation and each of its directors and executive offic
f ers.
10.43(2)
Form of Amended and Restated Indemnity Agreement, adopted April 24, 2009.
10.44(18)
Controlled Equity Offe
f ringSM Sales Agreement, dated December 11, 2020, by and among Cerus Corpor
r
ation, Cantor
Fitzgerald & Co. and Stifel, Nicolaus & Company, Incorporated.
10.45(23)
Amendment No. 1 to the Controlled Equity Offe
f ringSM Sales Agreement, dated March 1, 2023, by and among Cerus
Corporation, Cantor Fitzgerald & Co. and Stifel
f , Nicolaus & Company, Incorporated.
10.46(25)
Amendment No. 2 to the Controlled Equity Offe
f ringSM Sales Agreement, dated November 2, 2023, by and among Cerus
Corporation, Cantor Fitzgerald & Co. and Stifel
f , Nicolaus & Company, Incorporated.
10.47††
License Agreement, dated as of February 2
r
, 2005, by and between Cerus Corpor
r
ation and Fresenius Kabi AG (successor-
in-interest to Baxter Healthcare S.A. and Baxter Healthcare Corporation).
19.1
Cerus Corpor
r
ation Insider Trading Policy.

83
21.1
List of Registrant’s subs
u
idiaries.
23.1
Consent of Independent Registered Publ
u ic Accounting Firm.
24.1
Power of Attorney (see signature page).
31.1
Certific
f ation of the Principal Executive Offic
f er of Cerus Corpo
r
ration pursuant to Section 302 of the Sarba
r
nes-Oxley Act
of 2002.
31.2
Certific
f ation of the Principal Financial Offi
f cer of Cerus
r
Corporation pursuant to Section 302 of the Sarba
r
nes-Oxley Act
of 2002.
32.1(29)
Certific
f ation of the Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarba
r
nes-
Oxley Act of 2002.
97.1
Incentive Compensation Recoupment Policy.
101.INS
Inline XBRL Instance Document. – the instance document does not appear in the Interactive Data File because its XBRL
tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document.
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline XBRL Taxonomy Extension Labe
a
l Linkbase Document.
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
†
Certain portions of this exhibit are subj
u ect to a confid
f ential treatment order.
††
Certain portions of this exhibit (indicated by “[***]”) have been omitted as the Registrant has determined (i) the omitted
information is not material and (ii) the omitted infor
f
mation would likely cause harm to the Registrant if publicly disclosed.
*
Compensatory P
r
lan.
(1)
Incorpor
r
ated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-1 (File No.
333-11341) and amendments thereto.
(2)
Incorpor
r
ated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, file
f
d with the
SEC on April 30, 2009.
(3)
Incorpor
r
ated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, file
f
d with the
SEC on June 1, 2009.
(4)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2009.
(5)
Incorpor
r
ated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, file
f
d with the
SEC on May 18, 2011.
(6)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2012.

84
(7)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2012.
(8)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2012.
(9)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2014.
(10)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2015.
(11)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, file
f
d with the
SEC on August 31, 2016.
(12)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2016.
(13)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2018.
(14)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2018.
(15)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2018.
(16)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K for
f
the year
ended December 31, 2018.
(17)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q for
f
the quarter
ended June 30, 2020.
(18)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, file
f
d with the
SEC on December 11, 2020.
(19)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2020.
(20)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q for
f
the quarter
ended June 30, 2021.
(21)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q for
f
the quarter
ended June 30, 2022.
(22)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q for
f
the quarter
ended March 31, 2023.
(23)
Incorporated by reference to the like-described exhibit to the Registrant’s Post-Effective Amendment No. 1 to
Registration Statement (File No. 333-251302) on Form S-3, filed with SEC on March 1, 2023.
(24)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q for
f
the quarter
ended September 30, 2023.
(25)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement (File No. 333-275284)
on Form S-3, filed with SEC on November 2, 2023.
(26)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, file
f
d with the
SEC on January 5, 2024.

85
(27)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K for
f
the year
ended December 31, 2023.
(28)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q for
f
the quarter
ended June 30, 2024.
(29)
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange
Commission, and is not incorporated by reference into any filing of the Registrant’s under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended (whether made befor
f
e or after the date of the Form 10-K),
irrespective of any general incorpor
r
ation language contained in such fili
f
ng.
Item 16. Form 10-K S
-
ummary
None.

86
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Cerus Corpor
r
ation
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Cerus
r
Corporation (the Company) as of December 31, 2024 and
2023, the related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flo
f ws for each of the three
years in the period ended December 31, 2024, and the related notes (collectively refer
f red to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the fin
f ancial position of the Company at
December 31, 2024 and 2023, and the results of its operations and its cash flows for
f
each of the three years in the period ended
December 31, 2024, in confor
f
mity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Publ
u ic Company Accounting Oversight Board (United States) (PCAOB),
the Company's internal control over fin
f ancial reporting as of December 31, 2024, based on criteria established in Internal Control—
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our
report dated Februa
r
ry 26, 2025 expressed an unqualified opinion thereon.
Basis for
f
Opinion
These fin
f ancial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the
Company’s fin
f ancial statements based on our audits. We are a public accounting fir
f m registered with the PCAOB and are required to
be independent with respect to the Company in accordance with the U.S. fed
f
eral securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonabl
a e assurance about whether the financial statements are free of material misstatement, whether due
d
to error or fraud.
Our audits included performing procedur
d
es to assess the risks of material misstatement of the financial statements, whether due
d
to error
or fraud, and performing procedur
d
es that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and
significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that
our audits provide a reasonabl
a e basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was
communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material
to the fin
f ancial statements and (2) involved our especially challenging, subj
u ective or complex judgments. The communication of the
critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by
communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosures
to which it relates.
Revenue Recogn
o
itio
t n
Descript
i ion of t
o
he
t
Matter
In the year ended December 31, 2024, the Company recognized $180.3 million of product revenue. As discussed
in Note 2 to the consolidated financial statements, produc
d
t revenue is recognized upon
u
transfer
f
of control of
promised products or services to customers in an amount that reflects the consideration which the Company
expects to receive in exchange for those products or services. Product revenue from the sale of illuminators,
disposable kits, INTERCEPT Fibrinogen Complex, spare parts and storage solutions are recognized upon
u
the
transfer
f
of control of the products to the customer.
Auditing the Company’s revenue recognition was challenging due to variabi
a lity in terms and conditions within
certain customer contracts, whereby these customer contracts can include multiple products and/or services
requiring management to apply judgment to determine whether the products and services are distinct
performance obligations or should be accounted for as a combined performance obligation. Customer contracts
must be carefully evaluated for
f
terms that might affe
f ct the timing or measurement of revenue recognition.
How We A
W
ddressed
the Mat
M ter in Our
Audit
We obtained an understanding of, e
f
valuated the design and tested the operating effectiveness of controls over
the Company’s revenue recognition process, including management’s assessment of its performance
obligations.

87
Our audit procedur
d
es over the determination of the distinct perfor
f
mance obligations and the timing of revenue
recognition included, among others, obtaining an understanding of the terms of new revenue contracts by
reading both the Company’s summary documentation and the corresponding contract for a sample of new
revenue agreements. We also confir
f med a sample of customer contracts’ terms and conditions through direct
correspondence with the customers.
For a sample of individual sales transactions, we inspected the executed contract and purchase order to identify
the contract, identifie
f d the performance obligation(s) in the contract to compare to those identifie
f d by
management, and calculated the transaction price. For any transactions with multiple performance obligations,
we evaluated the Company’s allocation of the transaction price to the performance obligations. Further, we
inspected third-party evidence of transfer of control of the goods or services to the customer.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 1991.
San Mateo, Califor
f
nia
Februa
r
ry 26, 2025

88
CERUS CORPORAT
R
ION
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
December 31,
December 31,
2024
2023
ASSETS
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
Restricted cash
1,095
1,712
Non-current inventories
14,145
19,501
Other assets
16,801
11,425
Total assets
$
200,917
$
197,748
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
21,695
$
23,842
Accrue
r
d liabi
a lities
18,943
19,225
Debt – current
19,297
20,000
Operating lease liabi
a lities – current
2,275
2,452
Deferred revenue
1,398
2,002
Total current liabi
a lities
63,608
67,521
Non-current liabilities:
Debt – non-current
64,862
59,796
Operating lease liabi
a lities – non-current
11,663
13,751
Other non-current liabilities
3,888
3,236
Total liabi
a lities
144,021
144,304
Commitments and contingencies
Stockholders’ equity:
Prefer
f red stock, $0.001 par value; 5,000 shares authorized, issuable in series; zero
shares issued and outstanding at December 31, 2024 and 2023, respectively
Common stock, $0.001 par value; 400,000 and 400,000 shares authorized; 185,766 and 181,248
shares issued and outstanding at December 31, 2024 and 2023, respectively
186
181
Additional paid-in capi
a tal
1,121,887
1,098,353
Accumulated other comprehensive loss
(400)
(1,274)
Accumulated defic
f it
(1,065,528)
(1,044,610)
Total Cerus
r
Corporation stockholders’ equity
56,145
52,650
Noncontrolling interest
751
794
Total liabi
a lities and stockholders’ equity
$
200,917
$
197,748
See accompanying Notes to Consolidated Financial Statements.

89
CERUS CORPORAT
R
ION
CONSOLIDATED STATEMENTS OF OPERAT
R
IONS
(in thousands, except per share amounts)
Year Ended December 31,
2024
2023
2022
Product revenue
$
180,270
$
156,367
$ 162,048
Cost of product revenue
80,748
69,967
74,954
Gross profit on product revenue
99,522
86,400
87,094
Government contract revenue
21,051
30,430
26,267
Operating expenses:
Research and development
58,907
67,639
64,107
Selling, general and administrative
75,891
75,516
83,335
Restructur
t
ing
—
3,728
—
Total operating expenses
134,798
146,883
147,442
Loss from operations
(14,225)
(30,053)
(34,081)
Non-operating expense, net:
Foreign exchange gain (loss)
370
(648)
(690)
Interest expense
(8,877)
(8,386)
(5,831)
Other income (expense), net
1,976
1,765
(1,735)
Total non-operating expense, net
(6,531)
(7,269)
(8,256)
Loss before income taxes
(20,756)
(37,322)
(42,337)
Provision for income taxes
205
325
488
Net loss
(20,961)
(37,647)
(42,825)
Net loss attributable to noncontrolling interest
(43)
(158)
(46)
Net loss attributable to Cerus Corpor
r
ation
$
(20,918)
$
(37,489)
$
(42,779)
Net loss per share attributable to Cerus Corpor
r
ation
Basic and diluted
$
(0.11)
$
(0.21)
$
(0.24)
Weighted average shares outstanding:
Basic and diluted
184,563
180,270
176,545
See accompanying Notes to Consolidated Financial Statements.

90
CERUS CORPORAT
R
ION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Year Ended December 31,
2024
2023
2022
Net loss
$ (20,961)
$
(37,647)
$
(42,825)
Other comprehensive loss
Foreign currency translation adjustment
(14)
(85)
—
Unrealized gains (losses) on availabl
a e-for-sale investments, net of taxes
888
1,598
(2,638)
Comprehensive loss
(20,087)
(36,134)
(45,463)
Comprehensive loss attributable to noncontrolling interest
(43)
(158)
(46)
Total comprehensive loss attributable to Cerus Corpor
r
ation
$ (20,044)
$
(35,976)
$
(45,417)
See accompanying Notes to Consolidated Financial Statements.

91
CERUS CORPORAT
R
ION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
Common Stock
Additional
Paid-in
Accumulated
Other
Comprehensive
Accumulated
Noncontrolling
Total
Stockholders’
Shares
Amount
Capital
Income (Loss)
Deficit
Interest
Equity
Balance at December 31, 2021
173,670
$
174
$ 1,048,936
$
(149)
$
(964,342)
$
998
$
85,617
Issuance of common stock fro
f
m exercise of stock options, vesting of
restricted stock units, and ESPP purchases
3,912
3
3,949
—
—
—
3,952
Stock-based compensation
—
—
24,456
—
—
—
24,456
Other comprehensive loss
—
—
—
(2,638)
—
—
(2,638)
Net loss
—
—
—
—
(42,779)
(46)
(42,825)
Balance at December 31, 2022
177,582
$
177
$ 1,077,341
$
(2,787)
$ (1,007,121)
$
952
$
68,562
Issuance of common stock fro
f
m exercise of stock options, vesting of
restricted stock units, and ESPP purchases
3,666
4
741
—
—
—
745
Stock-based compensation
—
—
20,271
—
—
—
20,271
Other comprehensive income
—
—
—
1,513
—
—
1,513
Net loss
—
—
—
—
(37,489)
(158)
(37,647)
Balance at December 31, 2023
181,248
$
181
$ 1,098,353
$
(1,274)
$ (1,044,610)
$
794
$
53,444
Issuance of common stock fro
f
m vesting of restricted stock units and
ESPP purchases
4,518
5
667
—
—
—
672
Stock-based compensation
—
—
22,867
—
—
—
22,867
Other comprehensive income
—
—
—
874
—
—
874
Net loss
—
—
—
—
(20,918)
(43)
(20,961)
Balance at December 31, 2024
185,766
$
186
$ 1,121,887
$
(400)
$ (1,065,528)
$
751
$
56,896
See accompanying Notes to Consolidated Financial Statements.

92
CERUS CORPORAT
R
ION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended
December 31,
2024
2023
2022
Operating activities
Net loss
$
(20,961)
$ (37,647)
$ (42,825)
Adju
d stments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization
1,855
2,599
2,984
Stock-based compensation
22,867
20,271
24,456
Non-cash operating lease cost
2,482
2,308
1,575
Changes in valuation of warrant investment
—
—
2,183
Net loss on sale of availabl
a e-for-sale securities
7
54
108
Unrealized gain on investments
(135)
(170)
(564)
Loss on disposal of fixed assets
3
65
—
Impairment charges for
f
facilities consolidation
—
1,698
—
Non-cash interest expense
398
374
609
Foreign currency remeasurement (gain) loss
(388)
(685)
1,911
Changes in operating assets and liabi
a lities:
Accounts receivable
5,504
(1,102)
(9,200)
Inventories
7,030
(14,947)
(1,768)
Prepaid and other assets
(3,025)
(994)
1,168
Accounts payable
(1,477)
(7,335)
(4,905)
Accrue
r
d liabi
a lities and other non-current liabi
a lities
(2,198)
(9,070)
(1,263)
Deferred revenue
(603)
1,413
(84)
Net cash provided by (used in) operating activities
11,359
(43,168)
(25,615)
Investing activities
Capi
a tal expenditures
(2,837)
(4,597)
(2,000)
Purchases of investments
(42,975)
(2,486)
(29,640)
Proceeds fro
f
m matur
t
ities and sale of investments
37,682
15,707
40,104
Net cash (used in) provided by investing activities
(8,130)
8,624
8,464
Financing activities
Net proceeds from equity incentives
804
925
4,084
Net costs from public offe
f rings
(137)
(175)
(104)
Net (payments on) proceeds fro
f
m revolving line of credit
(703)
5,091
212
Proceeds fro
f
m loans, net of issuance costs
5,000
4,832
—
Net cash provided by fin
f ancing activities
4,964
10,673
4,192
Effe
f ct of exchange rates on cash, cash equivalents, and restricted cash
(191)
(128)
(727)
Net increase (decrease) in cash, cash equivalents, and restricted cash
8,002
(23,999)
(13,686)
Cash, cash equivalents, and restricted cash, beginning of period
13,359
37,358
51,044
Cash, cash equivalents, and restricted cash, end of period
$
21,361
$
13,359
$
37,358
Supplemental disclosure of cash flow information:
Cash paid for interest
$
9,295
$
9,210
$
5,100
Cash paid for income taxes
356
322
270
See accompanying Notes to Consolidated Financial Statements.

93
CERUS CORPORAT
R
ION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Nature of Operations and Basis of Presentation
Cerus Corpor
r
ation (the “Company”) was incorporated in September 1991 and is developing and commercializing the INTERCEPT
Blood System, which is designed to enhance the safety of blood components through pathogen reduc
d
tion. The Company has worldwide
commercialization rights for
f
the INTERCEPT Blood System for platelets, plasma, red blood cells, and cryopr
r
ecipitation.
The Company sells its INTERCEPT platelet and plasma systems in North America, Europe, Middle East and Afri
f ca, and other regions
around the world. Also in the United States (“U.S.”), the INTERCEPT Blood System for Cryoprecipitation is appr
a
oved for
f
the
production of INTERCEPT Fibrinogen Complex, a therapeutic product for
f
the treatment and control of bleeding, including massive
hemorrhage, associated with fibrinogen defic
f iency. The Company conducts significant research, development, testing and regulatory
compliance activities on its produc
d
t candidates that, together with anticipated selling, general and administrative expenses, are expected
to result in subs
u
tantial additional losses, and the Company may need to adju
d st its operating plans and programs based on the availability
of cash resources.
Note 2. Summary of Signific
f ant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include those of Cerus
r
Corporation, its subs
u
idiary, and its variabl
a e interest entity
in which the Company is the primary b
r
enefic
f iary in accordance with the consolidation accounting guidance, afte
f r elimination of all
intercompany accounts and transactions (together with Cerus Corpor
r
ation, hereinafte
f r “Cerus” or the “Company”). These consolidated
financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant
to the rul
r es and regulations of the Securities and Exchange Commission (“SEC”).
Use of Estimates
The preparation of fin
f ancial statements requires management to make estimates, assumptions and judgments that affe
f ct the reported
amounts of assets, liabi
a lities, revenue and expenses, and related disclosures of contingent assets and liabi
a lities. On an ongoing basis,
management evaluates its estimates, including those related to revenue recognition, the collectability of accounts receivabl
a e, inventory
r
classification and related reserves, fair values of investments, the allowance for
f
credit losses, stock-based compensation, goodwill, useful
f
lives of property and equipment, income taxes, and incremental borrowing rate, among others. The Company bases its estimates on
historical experience, fut
f ur
t
e proje
o ctions, and on various other assumptions that are believed to be reasonabl
a e under the circumstances.
Actual results may differ fro
f
m those estimates under diffe
f rent assumptions or conditions.
Revenue
Revenue is recognized by app
a
lying the following fiv
f e steps: (1) identify the contract(s) with a customer; (2) identify t
f
he performance
obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the
contract; and (5) recognize revenue when (or as) the entity satisfie
f s a performance obligation.
The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma
(“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), INTERCEPT Fibrinogen Complex
(“IFC”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems
directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company sells its
IFC primarily to hospitals and blood banks. The Company uses a binding purchase order or signed sales contract as evidence of a
contract and satisfaction of its policy. Generally, the Company’s sales contracts for
f
disposable kits and illuminators with its customers
do not provide for open retur
t
n rights, except within a reasonabl
a e time afte
f r receipt of goods in the case of defect
f
ive or non-confor
f
ming
product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must
determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are
accounted for as a combined perfor
f
mance obligation. The Company must allocate the transaction price to each performance obligation
on a relative SSP basis and recognize the product revenue when the performance obligation is satisfied. The Company determines the
SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company
estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to
the extent it is probabl
a e that a significant fut
f ur
t
e reversal of cumulative product revenue under the contract will not occur. Product revenue
is recognized upon
u
transfer
f
of control of promised products or services to customers in an amount that reflects the consideration to which
the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable
kits, IFC, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue
from maintenance services are recognized ratabl
a y on a straight-line basis over the term of maintenance as customers simultaneously

94
consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the
Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue.
The Company receives fundi
f
ng under its U.S. government contracts that support research and development of defin
f ed projects. The
Biomedical Advanced Research and Development Authority (“BARDA”) and the U.S. Food and Drug Administration (“FDA”)
contracts generally provide for reimbursement of approved costs incurred under the terms of the contracts. Revenue related to the cost
reimbursement provisions is recognized as the qualifie
f d direct and indirect costs on the projects are incurred. The Department of Defen
f
se
(“DoD”) contract provides for
f
payments upon completion of each milestone. Revenue from the DoD contract is recognized on the
application of the cost-to-cost input method, which measures the extent of progress towards completion of its single performance
obligation based on the ratio of actual costs incurred to the total estimated costs over the performance period of the agreement. Revenue
is recorded as a percentage of the transaction price based on the extent of progress towards completion. The Company invoices under
its U.S. government contracts using the provisional rates in the government contracts and thus is subj
u ect to future audits at the discretion
of the government. The Company believes that government contract revenue for periods not yet audited has been recorded in amounts
that are expected to be realized upon final audit and settlement. However, these audits could result in an adjustment to government
contract revenue previously reported, which adju
d stments could be potentially significant. Costs incurred related to services performed
under the contracts are included as a component of research and development or selling, general and administrative expenses in the
Company’s consolidated statements of operations. The Company’s use of estimates in recording accrued liabi
a lities for
f
government
contract activities (see “Use of Estimates” above
a
) affects the revenue recorded fro
f
m development fundi
f
ng and under the government
contracts.
Disa
i
ggr
a
egatio
t n of P
o
ro
P
duct Revenue
Product revenue by geographical locations of customers dur
d
ing the years ended December 31, 2024, 2023 and 2022, was as fol
f lows (in
thousands):
Year Ended December 31,
2024
2023
2022
Product revenue:
North America
$
121,794
$
99,187
$
103,978
Europe, Middle East and Afri
f ca
56,327
55,008
56,297
Other
2,149
2,172
1,773
Total product revenue
$
180,270
$
156,367
$
162,048
Contra
t
ct Balances
The Company invoices its customers based upon
u
the terms in the contracts, which generally require payment 30 to 60 days from
f
the
date of invoice. Accounts receivabl
a e are recorded when the Company’s right to the consideration is estimated to be unconditional. The
Company’s conditional rights to the consideration are recorded as contract assets. The Company had no contract assets as of
December 31, 2024 and December 31, 2023.
Contract liabi
a lities mainly consist of defer
f red revenue related to maintenance services, unshipped products, and uninstalled illuminators,
or receivables fro
f
m customers that are not yet recognized as revenue. Maintenance services are generally billed upfro
f
nt at the beginning
of each annual service period and recognized ratably over the contractua
t
l service period. The Company applies an optional exemption
to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less.
As of December 31, 2024 and December 31, 2023, the Company had $0.5 million and $1.5 million, respectively, of contract liabilities
related to the DoD included within “Deferred revenue” on the Company’s consolidated balance sheets.
Research and Development Expenses
Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of
the Company’s U.S. government contracts. R&D expenses include salaries and related expenses for scientific
f
and regulatory p
r
ersonnel,
non-cash stock-based compensation, payments to consultants, suppl
u
ies and chemicals used in in-house laboratories, costs of R&D
facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studi
t
es, other
labor
a
atory s
r
tudies, process development and product manufact
f
ur
t
ing for
f
research use.
The Company’s use of estimates in recording accrue
r
d liabi
a lities for R&D activities (see “Use of Estimates” above) affects the amounts
of R&D expenses recorded from development fundi
f
ng. Actual results may differ fro
f
m those estimates under diffe
f rent assumptions or
conditions.
Cash Equivalents
The Company considers all highly liquid investments with matur
t
ities of three months or less from the date of purchase to be cash
equivalents. These investments primarily consist of money market instrum
r
ents and are classified as availabl
a e-for-sale.

95
Investments
Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities
that are designated as availabl
a e-for-sale and classified as short-term investments. Availabl
a e-for-sale securities are carried at estimated
fair value. The Company views its availabl
a e-for-sale portfol
f io as availabl
a e for
f
use in its current operations. Unrealized gains and losses
derived by changes in the estimated fai
f r value of availabl
a e-for-sale securities are recorded in “Unrealized gains (losses) on available-
for-sale investments, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the
sale of availabl
a e-for-sale investments, if any, are determined on a specific identific
f ation method, and are recorded in “Other income
(expense), net” on the Company’s consolidated statements of operations. The costs of securities sold are based on the specific
identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting
from the purchase of debt securities as a component of interest income.
The Company also reviews its availabl
a e-for-sale securities on a regular basis to evaluate whether any security in an unrealized loss
position has expected credit loss by considering fact
f
ors such as historical experience, market data, issuer-specific fac
f
tors, and current
economic conditions. Expected credit losses, if any, are recorded in “Other income (expense), net” on the Company’s consolidated
statements of operations.
During the years ended December 31, 2024, 2023 and 2022, the Company recorded zero, zero and $2.2 million, respectively, of
impairment of investments in certain prefer
f red stock and warrants in “Other income (expense), net” on the Company’s consolidated
statements of operations.
Deferred Compensation Plan
The Company’s deferred compensation plan, pursuant to which compensation defer
f rals began in 2020, is a nonqualifie
f d defer
f red
compensation plan that allows highly compensated employees to defer up t
u
o 80 percent of their base salary and up t
u
o 100 percent of
their variabl
a e compensation each plan year. The Company may make discretionary contributions to each participant in an amount
determined each year. To fund
f
the defer
f red compensation plan’s long-term liability, the Company purchases Company-owned lifef
insurance contracts on certain employees. The insurance serves as an investment source for the funds being set aside. Participants in the
deferred compensation plan select the mutua
t
l funds
f
in which their compensation deferrals are deemed to be invested as a component of
the insurance contracts. As of December 31, 2024 and December 31, 2023, $2.8 million and $2.6 million, respectively, were included
in “Other assets” on the Company’s consolidated balance sheets, which represents the cash surrender value of the associated lifef
insurance policies. As of December 31, 2024 and December 31, 2023, $3.1 million and $2.8 million, respectively, were included in
“Other non-current liabi
a lities” on the Company’s consolidated balance sheets, which represents the carrying value of the liabi
a lity for
deferred compensation. Gains and losses on the investments related to the nonqualifie
f d defer
f red compensation plan are included in
“Other income (expense), net”, on the Company’s consolidated statements of operations, and corresponding changes in their deferred
compensation liabi
a lity are included in operating expenses.
Restricted Cash
As of December 31, 2024 and December 31, 2023, the Company’s restricted cash consisted primarily of a letter of credit relating to an
offi
f ce building lease. As of December 31, 2024 and December 31, 2023, the Company also had certain non-U.S. dollar denominated
deposits recorded as restricted cash in compliance with certain foreign contractua
t
l requirements.
Concentration of Credit Risk
Financial instrum
r
ents that potentially subj
u ect the Company to concentrations of credit risk consist primarily of cash equivalents,
availabl
a e-for-sale securities and accounts receivabl
a e.
Pursuant to the Company’s investment policy, subs
u
tantially all of the Company’s cash, cash equivalents and availabl
a e-for-sale securities
are maintained at major financial institutions of high credit standing. The Company monitors the fin
f ancial credit worthiness of the
issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment
portfol
f io. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment
policy. At December 31, 2024, the Company does not believe there is significant financial risk fro
f
m non-performance by the issuers of
the Company’s cash equivalents and short-term investments.
On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to
sell to on credit terms. Generally, the Company does not require collateral fro
f
m its customers to secure accounts receivabl
a e. To the
extent that the Company determines credit losses may occur, the Company maintains an allowance for
f
estimated credit losses on its
consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and
administrative expenses.
The Company had one and three customer(s) that accounted for more than 10% of the Company’s outstanding accounts receivabl
a es at
both December 31, 2024 and December 31, 2023, respectively. These customers cumulatively represented appr
a
oximately 37% and 51%
of the Company’s outstanding trade receivabl
a es at December 31, 2024 and December 31, 2023, respectively. To date, the Company has
not experienced collection diffi
f culties fro
f
m these customers.

96
Inventories
At December 31, 2024 and December 31, 2023, inventory c
r
onsisted of raw materials, work-in-process and finished goods. Finished
goods include INTERCEPT disposable kits, illuminators, and certain components for
f
the illuminators. Platelet and plasma systems’
disposable kits generally expire no later than 24 months from the date of manufac
f
ture. However, in the three months ended December
31, 2024, the Company received FDA approval for
f
an 18-month shelf life f
f
or
f
our platelet kits. Illuminators and individual components
do not have regulated expiration dates. Raw materials and work-in-process includes certain components that are manufact
f
ur
t
ed over a
protracted length of time before being ultimately incorporated and assembled by Fresenius, Inc. (with their affiliates, “Fresenius”) into
the fin
f ished INTERCEPT disposable kits. It is not customary f
r
or
f
the Company’s production cycle for inventory t
r
o exceed 12 months,
however, in certain circumstances the Company purchases inventory c
r
omponents it expects to consume beyond 12 months. The
Company uses its best judgment to fact
f
or in lead times for
f
the production of its raw materials, work-in-process and finished units to
meet the Company’s for
f
ecasted demands. Additionally, from time-to-time, the Company may engage in strategic longer-range inventory
r
purchases due to concentration of supplier risk, obsolescence of materials or components, or simply as safety stock to mitigate disrupt
u ion
to suppl
u
y. Based upon
u
estimated production needs and current inventory l
r
evels, the Company determines the amount of inventory
r
necessary for the next 12 months. Any amounts in excess of this 12 month rolling proje
o ction are classified as “Non-current inventories”
in the consolidated balance sheets. Changes to those estimates could potentially impact amounts recorded as current or non-current
assets.
Inventory i
r
s recorded at the lower of cost, determined on a fir
f st-in, first-out basis, or net realizable value. The Company uses judgment
to analyze and determine if the composition of its inventory i
r
s obsolete, slow-moving or unsalable and fre
f quently reviews such
determinations. The Company writes down specifically identifie
f d unusable, obsolete, slow-moving, or known unsalable inventory t
r
hat
has no alternative use in the period that it is fir
f st recognized by using a number of fac
f
tors including product expiration dates, open and
unful
f filled orders, and sales for
f
ecasts. Any write-down of its inventory t
r
o net realizable value establishes a new cost basis and will be
maintained even if certain circumstances suggest that the inventory i
r
s recoverabl
a e in subsequent periods. Costs associated with the write-
down of inventory a
r
re recorded within “Cost of product revenue” on the Company’s consolidated statements of operations. At
December 31, 2024 and December 31, 2023, the Company had $0.9 million and $0.7 million, respectively, for potential obsolete,
expiring or unsalable product.
Property and Equipment, net
Property and equipment is comprised of furnitur
t
e, equipment, leasehold improvements, construc
r
tion-in-progress, information
technology hardware and softw
f
are and is recorded at cost. At the time the property and equipment is ready for
f
its intended use, it is
depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to fiv
f e years). Leasehold improvements
are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements. During the
years ended December 31, 2024, 2023 and 2022, the Company had non-cash purchases of capital expenditures of less than $0.1 million,
$0.8 million and $0.7 million, respectively.
Goodwill
Goodwill is not amortized, but instead is subj
u ect to an impairment test performed on an annual basis, or more fre
f quently if events or
changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each year, or
more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to
determine whether it is more likely than not that the fai
f r value of a reporting unit is less than the carrying amount. If the Company
determines that it is more likely than not that the fai
f r value of a reporting unit is less than the carrying amount, the Company must then
proceed with performing the quantitative goodwill impairment test. The Company may choose not to perform the qualitative assessment
to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the
qualitative assessment to test goodwill for
f
impairment in any subs
u
equent period. The quantitative goodwill impairment test compares
the fai
f r value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it
operates as one reporting unit and estimates the fair value of its one reporting unit using the enterpr
r
ise appr
a
oach under which it considers
the quoted market capi
a talization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market
prices that are availabl
a e in active markets to be the best evidence of fai
f r value. The Company also considers other factors, which include
future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its
carrying amount, goodwill of the reporting unit is considered not impaired. If the carrying amount of the reporting unit’s goodwill
exceeds the implied fai
f r value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the
carrying amount of goodwill in the Company’s one reporting unit.
During the years ended December 31, 2024, 2023 and 2022, the Company did not dispose of, impair or recognize additional goodwill.
Long-lived Assets
The Company evaluates its long-lived assets for
f
impairment by continually monitoring events and changes in circumstances that could
indicate carrying amounts of its long-lived assets may not be recoverabl
a e. When such events or changes in circumstances occur, the
Company assesses recoverabi
a lity by determining whether the carrying value of such assets will be recovered through the undiscounted

97
expected future cash flo
f ws. If the expected undiscounted future cash flo
f ws are less than the carrying amount of these assets, the Company
then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets.
Foreign Currency
The func
f
tional currency of the Company’s Cerus
r
Europe B.V. subs
u
idiary is the U.S. dollar. Monetary assets and liabi
a lities denominated
in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabi
a lities
denominated in foreign currencies are remeasured in U.S. dollars using historical exchange rates. Product revenues and expenses are
remeasured using average exchange rates prevailing dur
d
ing the period. Remeasurements are recorded in “Foreign exchange loss” on the
Company’s consolidated statements of operations.
The func
f
tional currency of the JV (as defin
f ed below) is the Chinese Renminbi. Monetary assets and liabi
a lities denominated in foreign
currencies are remeasured in Renminbi using the exchange rates at the balance sheet date. The financial statements of JV are translated
into U.S. dollar for
f
consolidation. The JV’s balance sheet is translated using the month-end exchange rate, and the JV’s income statement
is translated using the monthly average exchange rate, the difference is recognized as cumulative translation adjustment.
Stock-Based Compensation
Stock-based compensation expense is measured at the grant-date based on the fai
f r value of the award and is recognized as expense on a
straight-line basis over the requisite service period, which is the vesting period, and is adjusted for
f
estimated forfeitures. To the extent
that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are
probabl
a e of being achieved.
See Note 12, Stock-Based Com
C
pe
m
nsation, for
f
further infor
f
mation regarding the Company’s stock-based compensation assumptions and
expenses.
Consolidated Variable Interest Entity
In Februa
r
ry 2021, the Company entered into an Equity Joint Venture Contract with Shandong Zhongbaokang Medical Implements Co.,
Ltd. (“ZBK”), to establ
a ish Cerus
r
Zhongbaokang (Shandong) Biomedical Co., LTD. (the “JV”) for
f
the purpos
r
e of developing, obtaining
regulatory a
r
pp
a
roval for
f
, and eventual manufactur
t
ing and commercialization of the INTERCEPT blood transfus
f
ion for
f
platelets and red
blood cells in the People’s Republic of China. The Company owns 51% of equity in the JV and consolidates the JV as it has determined
that the investment is a variabl
a e interest entity and that the Company is the primary b
r
enefic
f iary.
Operating expenses for
f
the JV were de minimis for all periods presented.
Income Taxes
The provision for income taxes is accounted for using an asset and liabi
a lity approach, under which deferred tax assets and liabi
a lities are
determined based on diffe
f rences between the financial reporting and tax bases of assets and liabi
a lities and are measured using the enacted
tax rates and laws that will be in effe
f ct when the diffe
f rences are expected to reverse. The Company does not recognize tax positions that
do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant
information. Use of a valuation allowance is not an appropriate subs
u
titute for derecognition of a tax position. The Company recognizes
accrued interest and penalties related to unrecognized tax benefit
f s in its income tax expense. Although the Company believes it more
likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the
Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. fed
f
eral tax retur
t
ns filed for
f
years 2004
through 2023, and Califor
f
nia tax returns file
f
d for
f
years through 2023, remain subj
u ect to examination by the taxing jurisdictions due to
unutilized net operating losses and research credits. The Company continues to carry a valuation allowance on substantially all of its net
deferred tax assets.
Net Loss Per Share Attributable to Cerus Corporation
Basic net loss per share attributable to Cerus Corpor
r
ation is computed by dividing net loss attributable to Cerus Corpo
r
ration by the
weighted average number of common shares outstanding for the period. Diluted net loss per share attributable to Cerus Corpo
r
ration
gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options,
employee stock purchase plan rights and restricted stock units, which are calculated using the treasury s
r
tock method. For the years ended
December 31, 2024, 2023 and 2022, all potentially dilutive securities outstanding have been excluded fro
f
m the computation of dilutive
weighted average shares outstanding because such securities have an antidilutive impact due to losses reported.
The fol
f lowing tabl
a e sets for
f
th the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss
per share for the years ended December 31, 2024, 2023 and 2022 (in thousands, except per share amounts):

98
Year Ended December 31,
2024
2023
2022
Numerator for
f
Basic and Diluted:
Net loss attributable to Cerus Corpor
r
ation
$
(20,918)
$
(37,489)
$
(42,779)
Denominator:
Basic weighted average number of shares outstanding
184,563
180,270
176,545
Effe
f ct of dilutive potential shares
—
—
—
Diluted weighted average number of shares outstanding
184,563
180,270
176,545
Net loss per share attributable to Cerus Corpor
r
ation:
Basic and diluted
$
(0.11)
$
(0.21)
$
(0.24)
The table below presents potential shares that were excluded fro
f
m the calculation of the weighted average number of shares outstanding
used for the calculation of diluted net loss per share. These are excluded fro
f
m the calculation due
d
to their anti-dilutive effect for the
years ended December 31, 2024, 2023 and 2022 (shares in thousands):
Year Ended December 31,
2024
2023
2022
Weighted average number of anti-dilutive potential shares:
Stock options
12,993
14,896
16,072
Restricted stock units
13,880
10,192
7,966
Employee stock purchase plan rights
349
396
252
Total
27,222
25,484
24,290
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in “Operating lease right-of-use assets”,
“Operating lease liabi
a lities – current” and “Operating lease liabi
a lities – non-current” in the Company’s consolidated balance sheets. As
of December 31, 2024 and December 31, 2023, the Company did not have finance leases.
Operating lease right-of-use assets and operating lease liabi
a lities are recognized at commencement date based on the present value of
lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at
commencement date in determining the present value of lease payments. The operating lease right-of-use assets also include any lease
payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when the options
are reasonabl
a y certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term.
Guarantee and Indemnific
f ation Arrangements
The Company recognizes the fai
f r value for guarantee and indemnific
f ation arrangements issued or modified by the Company. In addition,
the Company monitors the conditions that are subject to the guarantees and indemnific
f ations in order to identify i
f
f a loss has occurred.
If the Company determines it is probabl
a e that a loss has occurred, then any such estimabl
a e loss would be recognized under those
guarantees and indemnific
f ations. Some of the agreements that the Company is a party to contain provisions that indemnify t
f
he counter
party fro
f
m damages and costs resulting fro
f
m claims that the Company’s technology infringes the intellectua
t
l property rights of a third-
party or claims that the sale or use of the Company’s products have caused personal injury o
r
r other damage or loss. The Company has
not received any such requests for indemnific
f ation under these provisions and has not been required to make material payments pursuant
to these provisions.
The Company generally provides for
f
a one-year warranty on certain of its disposable kits and illuminators covering defects in materials
and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The
Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims.
Accordingly, the Company had not accrue
r
d for
f
any fut
f ur
t
e warranty costs for its products at December 31, 2024 and December 31, 2023.
Fair Value of Financial Instruments
The Company applies the provisions of fair value relating to its financial assets and liabi
a lities. The carrying amounts of accounts
receivabl
a es, accounts payable, and other accrue
r
d liabi
a lities approximate their fai
f r value due to the relative short-term maturities. Based
on the borrowing rates currently availabl
a e to the Company for
f
loans with similar terms, the Company believes the fair value of its debt
approximates their carrying amounts. The Company measures and records certain fin
f ancial assets and liabi
a lities at fai
f r value on a
recurring basis, including its available-for
f
-sale securities. The Company classifies instruments within Level 1 if quoted prices are
availabl
a e in active markets for identical assets, which include the Company’s cash accounts and money market funds
f
. The Company

99
classifies instruments in Level 2 if the instruments are valued using observabl
a e inputs to quoted market prices, benchmark yields,
reported trades, broker/dealer quotes or alternative pricing sources with reasonabl
a e levels of price transparency. These instruments
include the Company’s corporate debt and U.S. government agency securities holdings. The availabl
a e-for-sale securities are held by a
custodian who obtains investment prices from a third-party pricing provider that uses standard inputs (observabl
a e in the market) to
models which vary b
r
y asset class. The Company classifies instruments in Level 3 if one or more significant inputs or significant value
drivers are unobservabl
a e. The Company assesses any transfer
f s among fair value measurement levels at the end of each reporting period.
See Note 3, Available-fo
- r-sale Securities and Fair Value on Fin
F ancial Ins
I
truments, for
f
further infor
f
mation regarding the Company’s
valuation of fin
f ancial instruments.
New Accounting Pronouncements
Recently a
l
dopted
t
accountin
t
g pronouncementst
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-07, Impr
m
ovements to Repor
e
table
Segm
e
ent Disclosures (Topi
T
c 280). This ASU updates reportabl
a e segment disclosure requirements by requiring disclosures of significant
reportabl
a e segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and included within each
reported measure of a segment’s profit or loss. This ASU also requires disclosure of the title and position of the individual identifie
f d as
the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit
f
or loss in assessing segment
performance and deciding how to allocate resources. The ASU is effective for
f
annual periods beginning afte
f r December 15, 2023, and
interim periods within fiscal years beginning afte
f r December 15, 2024. Adoption of the ASU should be appl
a
ied retrospectively to all
prior periods presented in the financial statements. Early adoption is also permitted. The Company adopted ASU 2023-07 effe
f ctive
December 31, 2024, on a retrospective basis. The adoption of 2023-07 did not change the way that the Company identifies its reportabl
a e
segments and, as a result, did not have a material impact on the Company’s segment-related disclosures. Refer
f
to Note 16, Segm
e
ent,
Customer and Geographic Inf
I or
f
mation, for
f
further infor
f
mation on the Company’s reportabl
a e segment.
Recently i
l
ssu
i
ed accountin
t
g pronouncements not yet adopted
t
In December 2023, the FASB issued ASU No. 2023-09, Impr
m
ovements to Income Tax D
a
isclosures (Topi
T
c 740). The ASU requires
disaggregated information abo
a
ut a reporting entity’s effe
f ctive tax rate reconciliation as well as additional infor
f
mation on income taxes
paid. The ASU is effec
f
tive on a prospective basis for annual periods beginning afte
f r December 15, 2024. Early adoption is also permitted
for annual fin
f ancial statements that have not yet been issued or made availabl
a e for
f
issuance. The Company does not expect the adoption
of this guidance to have a material impact on the Company’s consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement–Re
–
por
e
ting Com
C
pr
m
ehensive Income–Exp
E
ense Disa
i
ggregation
Disc
i
losures (Subt
(
opic 220-40): Disaggregation of I
o
nc
I
ome Sta
S tement Expe
x
nses (“ASU 2024-03”), which requires disclosure about
a
the
types of costs and expenses included in certain expense captions presented on the income statement. The new disclosure requirements
are effective for
f
the Company’s annual periods beginning afte
f r December 15, 2026, and interim periods beginning afte
f r December 15,
2027, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on the
Company’s related disclosures.
The Company continues to monitor new accounting pronouncements issued by the FASB and does not believe any accounting
pronouncements issued through the date of this report will have a material impact on the Company’s Consolidated Financial Statements.
Note 3. Available-for-sale Securities and Fair Value on Financial Instruments
Available-fo
- r-sale Securities
The fol
f lowing is a summary of availabl
a e-for-sale securities at December 31, 2024 (in thousands):
December 31, 2024
Amortized
Cost
Gross
Unrealized Gain
Gross
Unrealized Loss
Allowance
for Credit
Loss
Fair Value
Money market funds
f
$
1,773
$
—
$
—
$
—
$
1,773
United States government agency
securities
24,060
54
(52)
—
24,062
Corporate debt securities
33,357
53
(39)
—
33,371
Mortgage-backed securities
3,070
—
(317)
—
2,753
Total availabl
a e-for-sale securities
$
62,260
$
107
$
(408)
$
—
$
61,959

100
The fol
f lowing is a summary of availabl
a e-for-sale securities at December 31, 2023 (in thousands):
December 31, 2023
Amortized
Cost
Gross
Unrealized Gain
Gross
Unrealized Loss
Allowance
for Credit
Loss
Fair Value
Money market funds
f
$
5,062
$
—
$
—
$
—
$
5,062
United States government agency
securities
19,652
16
(314)
—
19,354
Corporate debt securities
32,395
3
(638)
—
31,760
Mortgage-backed securities
3,347
7
(263)
—
3,091
Total availabl
a e-for-sale securities
$
60,456
$
26
$
(1,215)
$
—
$
59,267
Availabl
a e-for-sale securities at December 31, 2024 and December 31, 2023, consisted of the following by contractua
t
l maturi
t
ty (in
thousands):
December 31, 2024
December 31, 2023
Amortized Cost
Fair Value
Amortized Cost
Fair Value
One year or less
$
38,174
$
38,173
$
42,598
$
41,789
Greater than one year and less than fiv
f e years
24,086
23,786
17,858
17,478
Total availabl
a e-for-sale securities
$
62,260
$
61,959
$
60,456
$
59,267
The fol
f lowing tabl
a es show all availabl
a e-for-sale marketabl
a e securities in an unrealized loss position for
f
which an allowance for credit
losses has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category a
r
nd length of
time that individual securities have been in a continuous unrealized loss position (in thousands):
December 31, 2024
Less than 12 Months
12 Months or Greater
Total
Fair Value
Unrealized Loss
Fair Value
Unrealized Loss
Fair Value
Unrealized Loss
Corporate debt securities
$
14,002
$
(27) $
3,967
$
(12) $
17,969
$
(39)
United States government agency
securities
8,468
(37)
3,279
(15)
11,747
(52)
Mortgage-backed securities
402
(10)
2,351
(307)
2,753
(317)
Total
$
22,872
$
(74) $
9,597
$
(334) $
32,469
$
(408)
December 31, 2023
Less than 12 Months
12 Months or Greater
Total
Fair Value
Unrealized Loss
Fair Value
Unrealized Loss
Fair Value
Unrealized Loss
Corporate debt securities
$
1,466
$
(12) $
29,647
$
(626) $
31,113
$
(638)
United States government agency
securities
4,855
(25)
10,991
(289)
15,846
(314)
Mortgage-backed securities
242
(1)
2,647
(262)
2,889
(263)
Total
$
6,563
$
(38) $
43,285
$
(1,177) $
49,848
$
(1,215)
The Company typically invests in highly-rated securities, and its investment policy limits the amount of credit exposure to any one
issuer. The policy generally requires investments to be investment grade, with the primary objective of minimizing the potential risk of
principal loss. Fair values were determined for each individua
d
l security in the investment portfol
f io. When evaluating an investment for
expected credit losses, the Company reviews fact
f
ors such as the length of time and extent to which fair value has been below its cost
basis, the fin
f ancial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell,
or whether it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. The
Company also regularly reviews its investments in an unrealized loss position and evaluates the current expected credit loss by
considering fact
f
ors such as historical experience, market data, issuer-specific fact
f
ors, and current economic conditions. During the years
ended December 31, 2024, 2023 and 2022, the Company did not recognize any expected credit losses. The Company has no current

101
requirement or intent to sell the securities in an unrealized loss position. The Company expects to recover up t
u
o (or beyond) the initial
cost of investment for securities held.
The Company recorded less than $0.1 million of gross realized gains fro
f
m the sale or maturity of availabl
a e-for-sale investments dur
d
ing
the year ended December 31, 2024, 2023 and 2022, respectively. The Company recorded less than $0.1 million, $0.1 million and $0.1
million of gross realized losses fro
f
m the sale or maturity of availabl
a e-for-sale investments dur
d
ing the year ended December 31, 2024,
2023 and 2022, respectively.
Fair Value Disclosures
The Company uses certain assumptions that market participants would use to determine the fair value of an asset or liability in pricing
the asset or liabi
a lity in an orderly transaction between market participants at the measurement date. The identific
f ation of market
participant assumptions provides a basis for
f
determining what inputs are to be used for pricing each asset or liabi
a lity. A fair value
hierarchy has been establ
a ished which gives precedence to fair value measurements calculated using observabl
a e inputs over those using
unobservabl
a e inputs. This hierarchy prioritized the inputs into three broad levels as fol
f lows:
•
Level 1: Quoted prices in active markets for identical instruments
•
Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments)
•
Level 3: Significant unobservabl
a e inputs (including assumptions in determining the fair value of certain investments)
Money market fund
f
s are highly liquid investments and are actively traded. The pricing information on these investment instruments are
readily availabl
a e and can be independently validated as of the measurement date. This approach results in the classification of these
securities as Level 1 of the fai
f r value hierarchy.
To estimate the fai
f r value of Level 2 debt securities as of December 31, 2024, the Company’s primary pricing service relies on inputs
from multiple industry-
r
recognized pricing sources to determine the price for each investment. Corpor
r
ate debt and U.S. government
agency securities are systematically priced by this service as of the close of business each business day. If the primary pricing service
does not price a specific asset a secondary pricing service is utilized.
The fai
f r values of the Company’s fin
f ancial assets and liabi
a lities were determined using the following inputs at December 31, 2024 (in
thousands):
Balance sheet
Quoted
Prices in
Active
Markets for
f
Identical
Assets
Signific
f ant
Other
Observable
Inputs
Signific
f ant
Unobservable
Inputs
classification
Total
(Level 1)
(Level 2)
(Level 3)
Money market funds
f
Cash and cash equivalents $
1,773
$
1,773
$
—
$
—
United States government agency securities
Short-term investments
24,062
—
24,062
—
Corporate debt securities
Short-term investments
33,371
—
33,371
—
Mortgage-backed securities
Short-term investments
2,753
—
2,753
—
Total short-term investments
$
61,959
$
1,773
$
60,186
$
—
The fai
f r values of the Company’s fin
f ancial assets and liabi
a lities were determined using the following inputs at December 31, 2023 (in
thousands):
Balance sheet
Quoted
Prices in
Active
Markets for
f
Identical
Assets
Signific
f ant
Other
Observable
Inputs
Signific
f ant
Unobservable
Inputs
classification
Total
(Level 1)
(Level 2)
(Level 3)
Money market funds
f
Cash and cash equivalents $
5,062
$
5,062
$
—
$
—
United States government agency securities
Short-term investments
19,354
—
19,354
—
Corporate debt securities
Short-term investments
31,760
—
31,760
—
Mortgage-backed securities
Short-term investments
3,091
—
3,091
—
Total short-term investments
$
59,267
$
5,062
$
54,205
$
—
The Company did not have any transfers among fair value measurement levels dur
d
ing the years ended December 31, 2024 and
December 31, 2023.

102
The fol
f lowing tabl
a e provides a summary o
r
f the total (loss) gain recognized in the Company’s consolidated statements of operations due
to changes in the fair value of the warrant (in thousands):
Years Ended December 31,
2024
2023
2022
Loss from changes in the fair value of level 3 investments
$
—
$
—
$
(570)
Note 4. Inventories
Inventories at December 31, 2024 and December 31, 2023, consisted of the following (in thousands):
December 31, 2024
December 31, 2023
Raw materials
$
8,641
$
13,680
Work-in-process
22,522
20,668
Finished goods
21,132
25,021
Total inventories
52,295
59,369
Less: non-current inventories
14,145
19,501
Total current inventories
$
38,150
$
39,868
Non-current inventories primarily consists of raw materials and work-in-process.
Note 5. Property and Equipment, net
Property and equipment, net at December 31, 2024 and December 31, 2023, consisted of the following (in thousands):
December 31,
2024
2023
Machinery a
r
nd equipment
$
5,949
$
5,534
Computer equipment and software
3,969
3,949
Furniture and fix
f tures
2,008
2,008
Leasehold improvements
12,192
12,192
Consigned equipment
1,475
1,429
Total property and equipment, gross
25,593
25,112
Accumulated depreciation and amortization
(18,439)
(16,472)
Total property and equipment, net
$
7,154
$
8,640
Depreciation and amortization expense related to property and equipment, net was $2.0 million, $2.4 million and $2.5 million for the
years ended December 31, 2024, 2023 and 2022, respectively. As part of the Company’s restruc
r
turing plan, $0.7 million was recognized
as an impairment of long-lived assets for leasehold improvements and furnitur
t
e and fixtur
t
es and was recorded within “Restruc
r
turing”
on the Company’s consolidated statement of operations for the year ended December 31, 2023. No impairment charges were incurred
for the year ended December 31, 2024.
Note 6. Accrued Liabilities
Accrue
r
d liabi
a lities at December 31, 2024 and December 31, 2023, consisted of the following (in thousands):
December 31, 2024
December 31, 2023
Accrue
r
d compensation and related costs
$
11,939
$
11,822
Accrue
r
d professional services
3,406
3,139
Other accrued expenses
3,598
4,264
Total accrue
r
d liabi
a lities
$
18,943
$
19,225
Note 7. Restructuring
In June 2023, pursuant to the Board of Directors’ approval, the Company began implementing a restructur
t
ing plan to pursue greater
effi
f ciency and to realign its business and strategic priorities. This included a facilities consolidation strategy to cease use of a part of its

103
corporate office building under its operating lease (see Note 10, Commitments and Contingencies) and reduction in for
f
ce of its employee
base. Affected employees received severance consideration and continuation of benefits
f
, as well as transition assistance. During the
twelve months ended December 31, 2023, the Company recognized $3.7 million of restructur
t
ing charges related to severance cost and
facilities consolidation. The Company subs
u
tantially implemented the restruc
r
turing plan in 2023. The fol
f lowing is a summary of the
Company’s accrued restructur
t
ing costs for one-time termination benefit
f s, recorded within “Accrued liabi
a lities” on the Company’s
consolidated balance sheets (in thousands):
Balance at
Restructuring
Balance at
December 31, 2023
Charge
Cash Payments
December 31, 2024
One-time termination benefits
f
$
84
$
—
$
(84)
$
—
Other
238
—
(32)
206
Total
$
322
$
—
$
(116)
$
206
Note 8. Debt
Debt at December 31, 2024, consisted of the following (in thousands):
Principal
Unamortized
Discount
Net Carrying
Value
Term Loan
$
65,000
$
(138)
$
64,862
Revolving Loan
19,297
—
19,297
Total debt
84,297
(138)
84,159
Less: current portion
19,297
—
19,297
Non-current portion
$
65,000
$
(138)
$
64,862
Debt at December 31, 2023, consisted of the following (in thousands):
Principal
Unamortized
Discount
Net Carrying
Value
Term Loan
$
60,000
$
(204)
$
59,796
Revolving Loan
20,000
—
20,000
Total debt
80,000
(204)
79,796
Less: current portion
20,000
—
20,000
Non-current portion
$
60,000
$
(204)
$
59,796
Principal, interest and fee
f
payments on the Term Loan Credit Agreement (as defined below) at December 31, 2024, are expected to be
as follows (in thousands):
Year ended December 31,
Principal
Interest and Fees
Total
2025
$
—
$
7,581
$
7,581
2026
24,375
6,630
31,005
2027
32,500
2,998
35,498
2028
8,125
1,459
9,584
2029
—
—
—
Total
$
65,000
$
18,668
$
83,668
Loan Agre
g
ements
On March 29, 2019, the Company entered into a Credit, Security and Guaranty Agreement (Term Loan) (the “Prior Term Loan Credit
Agreement”) with MidCap F
a
inancial Trus
r
t (“MidCap”
a
) to borrow up t
u
o $70 million in three tranches (collectively “Prior Term Loan”),
with a matur
t
ity date of March 1, 2024. The fir
f st advance of $40.0 million (“Tranche 1”) was drawn by the Company on March 29, 2019,
with the proceeds used in part to repay in ful
f l the outstanding term loans and fees under a prior loan agreement. The second advance of
$15.0 million (“Tranche 2”) was drawn by the Company on March 29, 2021. The third advance of $15.0 million (“Tranche 3”) expired
on December 31, 2021. The borrowings under the Prior Term Loan bear interest at the sum of a fixed percentage spread and the greater
of (i) 1.80% or (ii) one month SOFR plus 0.1%.
On March 31, 2023, the Company entered into an Amended and Restated Credit, Security and Guaranty Agreement (Term Loan) (the
“Term Loan Credit Agreement”) which amended and restated the Prior Term Loan Credit Agreement. The Term Loan Credit Agreement

104
provides a secured term loan fac
f
ility in an aggregate principal amount of up to $75.0 million. The Company borrowed the first advance
of $40.0 million (“Tranche 1”) and the second advance of $15.0 million (“Tranche 2”) on the closing date to refin
f ance the term loans
under the Prior Term Loan Credit Agreement. Under the terms of the Term Loan Credit Agreement, (i) the third advance of $10.0
million (“Tranche 3”) was availabl
a e to the Company through July 1, 2024, and (ii) the four
f
th advance of $10.0 million (“Tranche 4”),
is availabl
a e to the Company through July 1, 2025, subj
u ect to the Company’s satisfaction of certain other conditions described in the
Term Loan Credit Agreement.
Tranche 1, Tranche 2, Tranche 3, and Tranche 4, each bear interest at a flo
f ating rate equal to the sum of the Term SOFR rate (subject to
a flo
f or of 1.00%) plus 6.50%. Interest on each term loan advance is due
d
and payable monthly in arrears. Interest only payments are due
for the first 36 months, and the remaining payments are due
d
over the remaining 24 months. The interest only payment period can be
extended for
f
12 months upon achievement of a specified trailing 12 month net revenue target. The interest rate at December 31, 2024 is
approximately 11.5%.
On September 1, 2023, the Company entered into Amendment 1 of the Term Loan Credit Agreement. At the close of this amendment,
the Company borrowed $5.0 million available under Tranche 3. On January 5, 2024 the Company entered into Amendment 2 of the
Term Loan Credit Agreement which was effec
f
tive December 31, 2023, which removed the minimum revenue condition applicable to
the remaining $5.0 million available in Tranche 3, which became eligible to be drawn at any time prior to July 1, 2024. The Company
borrowed the remaining $5.0 million available in Tranche 3 on March 27, 2024.
Prepayments of the term loans under the Term Loan Credit Agreement, in whole or in part, will be subj
u ect to early termination fees
f
which decline each year through the term of the Term Loan Credit Agreement. The Company also must pay an annual administrative
fee equal to a fractional percentage of the amount outstanding pursuant to the Term Loan Credit Agreement, and upon
u
the fin
f al payment
must also pay an exit fee
f
of a percentage of the amount borrowed pursuant to the Term Loan Credit Agreement (the “Exit Fee”). The
Company is required to pay a pro rata portion of the Exit Fee in connection with any prepayment. The Company uses the effective
interest method to recognize the Exit Fee over the term of the debt.
The Company also maintained a Credit, Security and Guaranty Agreement (Revolving Loan) (the “Prior Revolving Loan Credit
Agreement”) with MidCap.
a
The borrowing limit under the Prior Revolving Loan Credit Agreement was $15.0 million which had a
maturity date of March 1, 2024. The amount borrowed under the Prior Revolving Loan Credit Agreement could be increased, upon
u
request by the Company, by up t
u
o an additional $5.0 million, subj
u ect to agent and lender appr
a
oval and the satisfaction of certain
conditions.
On March 31, 2023, the Company entered into Amended and Restated Credit, Security and Guaranty Agreement (Revolving Loan) (the
“Revolving Loan Credit Agreement”) which amended and restated the Prior Revolving Loan Credit Agreement and has a maturity date
of March 1, 2028. The Revolving Loan Credit Agreement provides a secured revolving credit facility in an initial aggregate principal
amount of up to $20.0 million. The Company may request an increase in the total commitments under the Revolving Loan Credit
Agreement by up t
u
o an additional $15.0 million, subj
u ect to agent and lender appr
a
oval and the satisfaction of certain conditions.
Loans under the Revolving Loan Credit Agreement accrue
r
interest at a flo
f ating rate equal to the Term SOFR rate (subject to a flo
f or of
1.00%) plus 3.75%. Accrue
r
d interest on the revolving loans will be paid monthly and revolving loans may be borrowed, repaid and re-
borrowed until March 1, 2028, when all outstanding amounts must be repaid. Termination or permanent reductions of the revolving loan
commitment under the Revolving Loan Credit Agreement will be subj
u ect to termination fee
f
s which decline each year until the four
f
th
anniversary o
r
f the Revolving Loan Credit Agreement, at which time there is no early termination fee.
f
In connection with the Revolving Loan Credit Agreement, the Company is required to pay customary f
r
ees
f
, including an origination fee
f
equal to a fractional percentage of the original commitment amount at closing (and an equivalent origination fee
f
with respect to any
increased commitments at the time of the applicable increase), a monthly unused line fee
f
based upon
u
the average daily unused allowabl
a e
borrowing base of the revolving credit facility and a monthly collateral management fee
f
based upon
u
the average daily used portion of
the revolving credit facility. The Company is also required to maintain a minimum drawn balance under the revolving line or pay interest
on the minimum drawn balance.
As of December 31, 2024 and December 31, 2023, the Company had borrowed $19.3 million and $20.0 million, respectively, under the
Revolving Loan Credit Agreement, which is included in “Debt – current” in the Company’s consolidated balance sheets.
The Term Loan Credit Agreement and Revolving Loan Credit Agreement contain certain financial and non-financial covenants, with
which the Company was in compliance at December 31, 2024. Additionally, the Company’s obligations under both agreements are
secured by a security interest in subs
u
tantially all of the Company’s assets, with some exclusions.
Note 9. Leases
Operating Leases
The Company leases its offi
f ce facilities, located in Concord, Califor
f
nia and Amersfoor
f
t, the Netherlands, and certain equipment and
automobiles under non-cancelabl
a e operating leases with initial terms in excess of one year that require the Company to pay operating

105
costs, property taxes, insurance and maintenance. The operating leases expire at various dates through 2030, with certain of the leases
providing for renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to
terminate the lease early. The Company does not assume renewals in determination of the lease term unless the renewals are deemed to
be reasonabl
a y assured at lease commencement. The Company recorded the lease right-of-use asset and obligation at the present value
of lease payments over the lease term. The rates implicit in the Company’s leases are generally not readily determinabl
a e. The Company
must estimate its incremental borrowing rate to discount the lease payments to present value. Operating lease assets also include lease
incentives.
The Company reduced its offi
f ce space and ceased using appr
a
oximately 15,000 square feet of rentable area of corporate offic
f e building
during the third quarter of 2023. The Company recognized a loss of $1.7 million related to this facilities consolidation in the twelve
months ended December 31, 2023 included in “Restructur
t
ing” on the Company’s consolidated statement of operations.
Suppl
u
emental cash flo
f w infor
f
mation related to operating leases is as follows (dollars in thousands):
Year Ended
December 31,
2024
2023
2022
Cash payments for operating leases
$
3,684
$
4,188
$
3,345
Right-of-use assets obtained in exchange for operating lease obligations
231
1,476
1,401
December 31, 2024
December 31, 2023
Weighted-average remaining lease term
4.8 years
5.4 years
Weighted-average discount rate
8.6%
8.5%
Future minimum non-cancelabl
a e payments under operating leases as of December 31, 2024, were as follows (in thousands):
Operating Leases
2025
$
3,309
2026
3,160
2027
3,454
2028
3,272
2029
3,328
Thereafter
844
Total fut
f ur
t
e lease payments
$
17,367
Less imputed interest
3,429
Present value of lease liabi
a lities (1)
$
13,938
(1) Lease liabi
a lities include those operating leases that we plan to sublease as a part of our facilities consolidation restruc
r
turing effo
f
rts. See Note 7 for
additional infor
f
mation.
During the years ended December 31, 2024, 2023 and 2022, the Company recorded operating lease expenses of $3.9 million, $3.5
million and $3.2 million, respectively. As of December 31, 2024, the Company had no leases that have not yet commenced.

106
Note 10. Commitments and Contingencies
Purchase Com
C
mitments
The Company is party to agreements with certain providers for certain components of the INTERCEPT Blood System. Certain of these
agreements require minimum purchase commitments fro
f
m the Company. As of December 31, 2024, the Company had $31.6 million of
short-term purchase commitments and $2.6 million of long-term purchase commitments, which are not recorded in the Company’s
consolidated balance sheets.
Note 11. Stockholders’ Equity
Sales Agre
g
ement
On December 11, 2020, the Company entered into the Controlled Equity Offe
f ringSM Sales Agreement (the “Sales Agreement”) with
Cantor Fitzgerald & Co. and Stifel
f , Nicolaus & Company, Incorporated (each a “Sales Agent” and collectively, the “Sales Agents”),
under which the Company may issue and sell fro
f
m time to time up to $100.0 million of the Company’s common stock through or to the
Sales Agents, as sales agent or principal.
On March 1, 2023, the Company entered into Amendment No.1 to the Sales Agreement (the “Amended Sales Agreement”). Under the
Amended Sales Agreement, the Company was abl
a e to issue and sell fro
f
m time to time up to $96.8 million of the Company’s common
stock through or to the Sales Agents, as sales agent or principal. Under the Amended Sales Agreement, each Sales Agent receives
compensation based on an aggregate of 3% of the gross proceeds on the sale price per share of the Company’s common stock. The
issuance and sale of these shares by the Company pursuant to the Amended Sales Agreement are deemed an “at-the-market” offe
f ring
and are registered under the Securities Act of 1933, as amended.
During the year ended December 31, 2024, no shares of the Company’s common stock were sold under the Amended Sales Agreement.
At December 31, 2024, the Company had app
a
roximately $96.8 million of common stock availabl
a e to be sold under the Amended Sales
Agreement.
Note 12. Stock-Based Compensation
Employee Stock Plans
Empl
m oyee Stock Purchase Plan
The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock
purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of
Directors may authorize participation by eligible employees, including offi
f cers, in periodic offerings. Under the Purchase Plan, eligible
employee participants may purchase shares of common stock of the Company at a purchase price equal to 85% of the lower of the fai
f r
market value per share on the start date of the offe
f ring period or the fai
f r market value per share on the purchase date. The Purchase Plan
consists of a fix
f ed offe
f ring period of 12 months with two purchase periods within each offe
f ring period. In June 2020, the Company’s
stockholders approved an amendment and restatement of the Purchase Plan that increased the aggregate number of shares of common
stock authorized for issuance under the Purchase Plan by 1.5 million shares. In June 2024, the Company’s stockholders approved an
amendment and restatement of the Purchase Plan that increased the aggregate number of shares of common stock authorized for issuance
under the Purchase Plan by 2.0 million shares. At December 31, 2024, the Company had 2.3 million shares available for future issuance.
Equity Incentive Plans
The Company also maintains an equity compensation plan to provide long-term incentives for employees, contractors, and members of
its Board of Directors.
2008 Equity Incentive Plan
Prior to the approval by the Company’s stockholders in June 2024 of the 2024 Equity Incentive Plan (the “2024 Plan”), the Company
granted equity awards from the 2008 Equity Incentive Plan and its subsequent amendments (collectively, the “Amended 2008 Plan”).
The Amended 2008 Plan allowed for
f
the issuance of non-statut
t ory a
r
nd incentive stock options, restricted stock, restricted stock units
(“RSUs”), stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other
property. In June 2019, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased
the aggregate number of shares of common stock authorized for issuance by 11.8 million shares. In June 2020, the Company’s
stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of
common stock authorized for issuance by 5.0 million shares. In June 2021, the Company’s stockholders approved an amendment and
restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance by 7.6
million shares. In June 2022, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that
increased the aggregate number of shares of common stock authorized for issuance by 12.0 million shares. In June 2023, the Company’s
stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of

107
common stock authorized for issuance by 7.0 million shares. Following the approval by the Company’s stockholders in June 2024 of
the 2024 Plan, no additional awards will be granted under the Amended 2008 plan. Option awards under the Amended 2008 Plan
generally have a maximum term of ten years fro
f
m the date of the award. The Amended 2008 Plan generally required options to be
granted at 100% of the fai
f r market value of the Company’s common stock subj
u ect to the option on the date of grant. Options granted by
the Company to employees generally vest over four
f
years. RSUs are measured based on the fai
f r market value of the underlying stock
on the date of grant. RSUs granted by the Company to employees generally vest over three to four years. Performance-based stock
awards granted under the Amended 2008 Plan were limited to 500,000 shares of common stock per recipient per calendar year.
Performance-based cash awards granted under the Amended 2008 Plan were limited to $1.0 million per recipient per calendar year. At
December 31, 2024, 2.6 million shares of performance-based stock awards were outstanding.
2024 Equity Incentive Plan
In June 2024, the Company’s stockholders approved the 2024 Plan. The 2024 Plan is intended as the successor to and continuation of
the Amended 2008 Plan. No additional awards will be granted under the Amended 2008 Plan. The shares remaining available for grant
under the Amended 2008 Plan as of the effective date of the 2024 Plan, plus an additional 5.0 million shares of common stock are
availabl
a e for
f
grant and issuance under the 2024 Plan. In addition, the fol
f lowing shares of common stock subject to any outstanding
award granted under either the Amended 2008 Plan or the Cerus
r
Corporation Inducement Plan will become availabl
a e for
f
grant and
issuance under the 2024 Plan: (i) any shares subject to such award that on or following the effective date of the 2024 Plan are not issued
because such award expires or otherwise terminates without all of the shares covered by such award having been issued; (ii) any shares
subj
u ect to such award that on or fol
f lowing the effec
f
tive date of the 2024 Plan are not issued because such award is settled in cash; and
(iii) any shares issued pursuant to such award that on or following the effective date of the 2024 Plan are for
f
feited back to or repurchased
by us because of a fai
f lure to vest. Option awards under the 2024 Plan generally have a maximum term of ten years from
f
the date of the
award. The 2024 Plan generally requires options to be granted at 100% of the fai
f r market value of the Company’s common stock subj
u ect
to the option on the date of grant. Options granted by the Company to employees generally vest over four
f
years. RSUs are measured
based on the fair market value of the underlying stock on the date of grant. RSUs granted by the Company to employees generally vest
over three to four years.
At December 31, 2024, the Company had appr
a
oximately 26.0 million shares of its common stock subj
u ect to a combination of outstanding
options and unvested RSUs outstanding under the 2024 Plan, of which approximately 12.3 million shares and 13.7 million shares were
subj
u ect to outstanding options and unvested RSUs, respectively. Approximately 12.7 million shares were available for future issuance
under the 2024 Plan. The Company’s policy is to issue new shares of common stock upon the exercise of options or vesting of RSUs.
Activity under the Company’s equity incentive plans related to stock options is set for
f
th below (in thousands except per share amounts):
Number of
Options Outstanding
Weighted Average
Exercise Price
per Share
Balance at December 31, 2023
14,515
$
5.20
Granted
—
—
Exercised
—
—
Forfeited/canceled
(2,218)
5.79
Balance at December 31, 2024
12,297
5.10
Activity under the Company’s equity incentive plans related to RSUs is set for
f
th below (in thousands except per share amounts):
Number of
RSUs Unvested
Weighted Average
Grant Date Fair Value
per Share
Balance at December 31, 2023
10,686
$
3.74
Granted (1)
7,729
2.14
Vested (1)
(4,029)
4.22
Forfeited (1)
(725)
3.02
Balance at December 31, 2024
13,661
2.73
(1) Includes shares issuabl
a e under performance-based restricted stock unit awards.

108
The total fair value of RSUs as of their respective vesting dates, for
f
the years ended December 31, 2024, 2023 and 2022, were
$8.4 million, $8.7 million and $15.0 million, respectively.
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisabl
a e
at December 31, 2024, was as fol
f lows (in thousands except weighted average exercise price and contractua
t
l term):
Number of Shares
Weighted Average
Exercise Price
Weighted Average
Remaining
Contractual Term
(Years)
Aggregate
Intrinsic Value
Balance at December 31, 2024
Stock options outstanding
12,297
$
5.10
3.60
—
Stock options vested and expected to vest
12,295
5.10
3.60
—
Stock options exercisabl
a e
11,796
5.06
3.46
—
The aggregate intrinsic value in the tabl
a e above
a
is calculated as the diffe
f rence between the exercise price of the stock option and the
Company’s closing stock price on the last trading day of each respective fis
f cal period.
There were no stock options exercised dur
d
ing the years ended December 31, 2024 and December 31, 2023. The total intrinsic value of
options exercised for
f
the year ended December 31, 2022 was $1.1 million. The total intrinsic value of exercised stock options is
calculated based on the diffe
f rence between the exercise price and the quoted market price of the Company’s common stock as of the
close of the exercise date.
Stock-based Compensation Expense
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December
31, 2024, 2023 and 2022, was as fol
f lows (in thousands):
Year Ended December 31,
2024
2023
2022
Research and development
$
5,897
$
5,823
$
5,635
Selling, general and administrative
16,970
14,448
18,821
Total stock-based compensation expense
$
22,867
$
20,271
$
24,456
Stock-based compensation expense in the above tabl
a e does not reflect any income taxes as the Company has experienced a history of
net losses since its inception and has a nearly full valuation allowance on its deferred tax assets. In addition, there was neither income
tax benefit
f s realized related to stock-based compensation expense nor any stock-based compensation costs capitalized as part of an asset
during the years ended December 31, 2024, 2023 and 2022.
As of December 31, 2024, the Company expects to recognize the remaining unamortized stock-based compensation expense of $1.4
million related to non-vested stock options and $19.5 million related to RSUs, net of estimated for
f
feitures, over an estimated remaining
weighted average period of 1.0 years and 1.3 years, respectively.
Valuation Assumptions for Stock-based Compensation
The Company uses the Black-Scholes option pricing model to determine the grant-date fai
f r value of stock options and employee stock
purchase plan rights. The Black-Scholes option-pricing model is affected by the Company’s stock price, as well as assumptions regarding
a number of complex and subjective variabl
a es, which include the expected term of the grants, actua
t
l and projected employee stock
option exercise behaviors, including forfeitur
t
es, the Company’s expected stock price volatility, the risk-free interest rate and expected
dividends. The Company recognizes the grant-date fai
f r value of the stock award as stock-based compensation expense on a straight-line
basis over the requisite service period, which is the vesting period, and is adjusted for
f
estimated for
f
feitures.
The expected life o
f
f the stock options is based on observed historical exercise patterns. Groups of employees having similar historical
exercise behavior are considered separately for valuation purpos
r
es. The Company estimates stock option for
f
feitur
t
es based on historical
data for employee groups. The total number of stock options expected to vest is adju
d sted by actua
t
l and estimated for
f
feitures.
The expected volatility is estimated by using historical volatility of the Company’s common stock. The risk-free interest rate is based
on the implied yield on a U.S. Treasury z
r
ero-coupon issue with a remaining term commensurate with the expected term of the option.
The Company does not anticipate paying any cash dividends in the for
f
eseeable future and therefore uses an expected dividend yield of
zero.

109
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2024, 2023 and
2022, was as fol
f lows:
Year Ended December 31,
2024
2023
2022
Stock Options:
Expected term (in years)
—
—
6.82
Estimated volatility
—
—
55%
Risk-free interest rate
—
—
1.89%
Expected dividend yield
—
—
0%
Employee Stock Purchase Plan Rights:
Expected term (in years)
0.75
0.75
0.74
Estimated volatility
79%
70%
56%
Risk-free interest rate
4.66%
5.29%
2.25%
Expected dividend yield
0%
0%
0%
There were no stock options granted dur
d
ing the year ended December 31, 2024 and December 31, 2023. The weighted average grant-
date fair value of stock options granted dur
d
ing the year ended December 31, 2022 was $3.12 per share. The weighted average grant-date
fair value of employee stock purchase rights dur
d
ing the years ended December 31, 2024, 2023 and 2022, was $0.92 per share, $0.88 per
share and $1.63 per share, respectively.
Note 13. Retirement Plan
The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k) of
the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S.
employees may make pre-tax dollar or post-tax (Roth) contributions of up to 60% of their eligible pay up t
u
o a maximum cap establ
a ished
by the IRS. The Company may contribute a discretionary percentage of qualifie
f d individual employee’s salaries, as defined, to the
401(k) Plan. In 2019, the Company began providing a 401(k) match, subj
u ect to certain limitations. Under the 401(k) match, the Company
matches 50% of the fir
f st 6% of each employee’s 401(k) contribution, up to an annual maximum of $5,000. The employer match will
vest immediately.
Note 14. Development and License Agreements
Agreements with Fresenius
In May 2022, the Company entered into the Second Amended and Restated Suppl
u
y and Manufact
f
ur
t
ing Agreement (“2022 Agreement”)
with Fresenius Kabi AG, Fenwal France SAS, and Fenwal International, Inc. (collectively, “Fresenius”) for the manufact
f
ur
t
e and
production of disposable sets for the INTERCEPT Blood System until December 31, 2031. Under the terms of the 2022 Agreement,
Fresenius is obligated to manufact
f
ur
t
e, and Company is obligated to purchase, finished disposable kits for the platelet and plasma
systems. Fresenius sources most of the components used in the production of disposable kits, except for
f
certain other components that
the Company sources from other third-parties and provides to Fresenius for inclusion into the fin
f ished disposable kits. The 2022
Agreement permits the Company to purchase sets for
f
the platelet and plasma systems fro
f
m third-parties to the extent necessary to
maintain suppl
u
y qualific
f ations with such third-parties or where local or regional manufact
f
ur
t
ing is needed to obtain product registrations
or sales. Fresenius will expand manufact
f
ur
t
ing of the disposable sets to three production facilities, following qualific
f ation and licensure
of such additional fac
f
ilities. The term of the 2022 Agreement will automatically renew for
f
successive two-year periods unless terminated
by either party upon
u
two years’ prior written notice, in the case of the initial term, or one year prior written notice, in the case of any
successive renewal term. Each party has normal and customary t
r
ermination rights, including termination for
f
material breach. Pricing
under the 2022 Agreement for
f
the initial term is based on volume purchases by the Company and subject to an annual adjustment based
on variation in a price index.
Government contracts
In June 2016, the Company entered into an agreement with BARDA (“2016 BARDA Agreement”) to suppor
u
t the Company’s
development and implementation of pathogen reduc
d
tion technology for platelet, plasma, and red blood cells.
The 2016 BARDA agreement and its subsequent modifications include a base period (the “Base Period”) and option periods (each, an
“Option Period”). The agreement includes committed fundi
f
ng for clinical development of the INTERCEPT Blood System for red blood
cells (the “red blood cell system”). In September 2023, BARDA committed an additional $3.5 million raising the committed fun
f
ding to
up to $185.5 million as of December 31, 2024. However, the potential for
f
the exercise by BARDA of subs
u
equent Option Periods that,
if exercised by BARDA and completed, was reduced by $8.8 million and would bring the total funding opportunity to $270.2 million
through September 2026. If exercised by BARDA, subsequent Option Periods would fund
f
activities related to broader implementation

110
of the platelet and plasma system or the red blood cell system in areas of emerging pathogens, clinical and regulatory d
r
evelopment
programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufact
f
ur
t
ing and scale-up
activities for
f
the red blood cell system. The Company could be responsible for up t
u
o $1.4 million of co-investment if certain Option
Periods are exercised. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is
based on the Company’s success in completing the required tasks under the Base Period and each exercised Option Period. BARDA has
rights under certain contract clauses to terminate the agreement, including the abi
a lity to terminate the agreement for
f
convenience at any
time. As of December 31, 2024 and December 31, 2023, $2.4 million and $5.6 million, respectively, of billed and unbilled amounts
were included in “Accounts receivable, net” on the Company’s consolidated balance sheets related to the 2016 BARDA agreement.
In September 2024, the Company entered into a new agreement with BARDA (“2024 BARDA Agreement”). The 2024 BARDA
agreement builds on the 2016 BARDA agreement and aims to further advance the development of the red blood cell system. The 2024
BARDA agreement includes access to fundi
f
ng that is intended to support a planned FDA modular premarket appr
a
oval appl
a
ication and
potential post-approval studies, accelerate development of an improved version of the red blood cell system, and scale up chemistry,
r
manufac
f
turing, and controls activities to enabl
a e a broad product launch, if approved. The six-year agreement with BARDA includes a
base period (the “2024 Base Period”) with committed fun
f
ding of up to $32.1 million, and subsequent option periods (each, a “2024
Option Period”) that, if exercised by BARDA and completed, would bring the total fundi
f
ng opportuni
t
ty to $188.4 million as of December
31, 2024. The Company could be responsible for cost sharing of up to $60.1 million. BARDA will make periodic assessments of the
Company’s progress, and the continuation of the agreement is based on the Company’s success in completing the required tasks under
the 2024 Base Period and each 2024 Option Period (if and to the extent any 2024 Option Periods are exercised by BARDA). BARDA
has rights under certain contract clauses to terminate the 2024 BARDA agreement, including the abi
a lity to terminate for
f
convenience at
any time. Under the contract, the Company will be reimbursed and recognize revenue as qualifie
f d direct contract costs are incurred plus
allowabl
a e indirect costs, based on app
a
roved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and
general and administrative expenses. As of December 31, 2024, $0.1 million of billed amount was included in “Accounts receivable,
net” on the Company’s consolidated balance sheets related to the 2024 BARDA agreement.
In September 2020, the Company entered into a five-year agreement with the FDA for the development of next-generation compounds
to optimize pathogen reduc
d
tion treatment of whole blood to reduce the risk of transfus
f
ion-transmitted infect
f
ions. The total contract value
is $11.1 million. As of December 31, 2024 and December 31, 2023, $0.5 million and $0.5 million, respectively, of billed and unbilled
amounts were included in “Accounts receivabl
a e, net” on the Company’s consolidated balance sheets related to FDA.
In September 2022, the Company entered into an agreement with the U.S. Department of Defense, or DoD, Industrial Base Analysis
and Sustainment program for the development of pathogen reduc
d
ed, lyophilized cryopr
r
ecipitate to treat bleeding due to trauma. In May
2023, the Company and the DoD entered into an amendment to the agreement to extend the agreement to February 2
r
027 and increased
the total contract value fro
f
m $9.1 million to $17.8 million. The revenue associated with the DoD contract is recognized on the appl
a
ication
of the cost-to-cost input method, which measures the extent of progress towards completion of the single performance obligation based
on the ratio of actual costs incurred to the total estimated costs over the performance period of the agreement. Revenue is recorded as a
percentage of the transaction price based on the extent of progress towards completion. The estimate of the Company’s measure of
progress, which can include additional services, if any, and the estimate of any additional consideration for
f
those additional services, if
any, are included in the transaction price which is upda
u
ted at each reporting date, and revenue is recognized on a cumulative catch-up
u
basis. As such, management appl
a
ies a certain amount of judgment in estimating both the services and the corresponding timeline through
to completion of the perfor
f
mance obligation, which are key inputs when using the cost-to-cost input method. Given that the estimate of
the Company’s measure of progress is upda
u
ted at each reporting date, and revenue is recognized on a cumulative catch-up b
u
asis, a
significant change in the remaining estimated costs to complete the services (including revisions to transaction price) could have a
significant impact on revenues previously recognized under this arrangement (including reversal of previously recognized revenue) at
each reporting date.
As of December 31, 2024 and December 31, 2023, $1.0 million and $3.7 million, respectively, of billed amount was included in
“Accounts receivabl
a e, net” on the Company’s consolidated balance sheets related to DoD. As of December 31, 2024 and December 31,
2023, $0.5 million and $1.5 million, respectively, were included in “Deferred revenue” as contract liabi
a lities on the Company’s
consolidated balance sheets related to the DoD contract.
Note 15. Income Taxes
U.S and foreign components of consolidated loss before income taxes for
f
the years ended December 31, 2024, 2023 and 2022, was as
follows (in thousands):
2024
2023
2022
Loss before income taxes:
U.S.
$
(21,318)
$
(38,281)
$
(43,096)
Foreign
562
959
759
Loss before income taxes
$
(20,756)
$
(37,322)
$
(42,337)

111
The provision for income taxes for the years ended December 31, 2024, 2023 and 2022, was as fol
f lows (in thousands):
2024
2023
2022
Provision for income taxes:
Current:
Foreign
$
130
$
285
$
520
Federal
—
—
—
State
70
36
5
Total current
200
321
525
Deferred:
Foreign
—
—
—
Federal
3
2
(18)
State
2
2
(19)
Total defer
f red
5
4
(37)
Provision for income taxes
$
205
$
325
$
488
The diffe
f rence between the provision for income taxes and the amount computed by applying the fed
f
eral statut
t ory i
r
ncome tax rate to
loss before taxes for
f
the years ended December 31, 2024, 2023 and 2022, was as fol
f lows (in thousands):
2024
2023
2022
Federal statutory tax
$
(4,359)
$
(7,838)
$
(8,891)
Federal research credits
(853)
(1,065)
(1,874)
State research credits
(767)
(642)
(822)
Expiration of federal carryovers
5,206
7,284
4,858
Change in valuation allowance
(2,357)
1,361
6,379
Compensation related items
4,015
3,257
1,794
State taxes
(259)
(1,710)
(1,127)
Revision to prior year items
(676)
(664)
—
Other
255
342
171
Provision for income taxes
$
205
$
325
$
488
Deferred income taxes refle
f ct the net tax effects of temporary d
r
iffe
f rences between the carrying amounts of assets and liabi
a lities for
f
financial reporting purpos
r
es and the amounts used for
f
income tax purpos
r
es at the enacted rates. The significant components of the
Company’s defer
f red tax assets and liabi
a lities at December 31, 2024, 2023 and 2022, were as follows (in thousands):
December 31,
2024
2023
Deferred tax assets:
Net operating loss carryforwards
$
127,184
$
133,476
Research and development credit carryforwards
29,739
28,567
Capi
a talized research and development
35,861
33,571
Compensation related items
9,437
10,306
Operating leases
3,005
3,462
Other
10,928
9,823
Total defer
f red tax assets
216,154
219,205
Valuation allowance
(214,321)
(216,888)
Net defer
f red tax assets
$
1,833
$
2,317
Deferred tax liabi
a lities:
Right-of-use assets
$
1,676
$
2,173
Other
226
209
Total defer
f red tax liabilities
$
1,902
$
2,382

112
The valuation allowance decreased by $2.6 million for
f
the year ended December 31, 2024, compared to the increase of $1.0 million and
$6.4 million for
f
the years ended December 31, 2023 and 2022, respectively. The Company believes that, based on a number of fac
f
tors,
the availabl
a e objective evidence creates sufficient uncertainty regarding the realizability of the defer
f red tax assets such that a valuation
allowance has been recorded. These factors include the Company’s history of net losses since its inception, the need for regulatory
r
approval of the Company’s products prior to commercialization and expected near-term fut
f ur
t
e losses. The Company expects to maintain
a valuation allowance until circumstances change.
For the year ended December 31, 2024, the Company reported pretax net losses on its consolidated statement of operations and calculated
taxabl
a e losses for
f
federal purpo
r
ses and varying taxable income and losses for
f
state purpos
r
es based on individual jurisdictions. The
differences between reported net loss and taxabl
a e income or loss are due to differences between book accounting and the respective tax
laws. The most notabl
a e diffe
f rences are the treatment of research and development expenses and compensation related items
The Company’s tax losses and credits are subject to varying carryforward periods. The gross amounts and dates of expiration of the
significant carryforwards are as fol
f lows:
Expires
Expires
Expires
No
Total
2025-2027
2028-2034
2035-2044
Expiration
Federal losses carryovers
$
559,551
$
58,345
$
193,684
$
116,604
$
190,918
Califor
f
nia loss carryovers
108,685
—
67,796
40,889
—
Other state loss carryo
r
vers
45,090
128
2,762
30,630
11,570
Federal research credits
17,074
1,279
1,927
13,868
—
Califor
f
nia research credits
16,011
—
—
—
16,011
Federal for
f
eign tax credits
610
610
—
—
—
The Company’s abi
a lity to utilize net operating loss and research and development credit carryforwards is limited by (a) its ability to
generate future taxabl
a e income, (b) varyi
r ng apportionment and allocation rul
r es, and (c) limitations pursuant to the ownership change
rules in accordance with Section 382 of the Internal Revenue Code of 1986 and with Section 383 of the Internal Revenue Code of 1986,
as well as similar state provisions.
The Company’s unrecognized tax benefit
f s primarily relate to federal and Califor
f
nia research tax credits. These tax credits have not been
utilized on any tax return and currently have no impact on the Company’s tax expense due
d
to the Company’s operating losses and the
related valuation allowances. There are additional unrecognized tax benefits related to for
f
eign activities.
The fol
f lowing is a tabular reconciliation of the total amounts of unrecognized tax benefit
f s (in thousands):
December 31,
December 31,
2024
2023
Unrecognized tax benefits at beginning of period
$
7,924
$
8,652
Decreases related to expired carryforwards
(344)
(1,126)
Decreases related to administrative proceedings
(127)
—
Increases related to prior year tax positions
94
100
Increases related to current year tax positions
290
298
Unrecognized tax benefits at end of period
$
7,837
$
7,924
The Company recognizes accrued interest and penalties related to unrecognized tax benefits
f
in its income tax expense.
Note 16. Segment, Customer and Geographic Infor
f
mation
The Company manages its business activities on a consolidated basis and operates in one reportabl
a e segment. The Company’s Chief
Executive Offi
f cer is the Chief Operating Decision Maker (“CODM”). The CODM makes decisions on resource allocation, assesses
performance of the business, and monitors budget versus actua
t
l results using loss fro
f
m operations.
Significant expenses within loss from operations include cost of product revenue, research and development, and selling, general and
administrative expenses, which are each separately presented on the Company’s Consolidated Statements of Operations.
The Company’s operations outside of the U.S. include a wholly-owned subs
u
idiary headquartered in Europe. The Company’s operations
in the U.S. are responsible for the R&D and global and domestic commercialization of the INTERCEPT Blood System, while operations
in Europe are responsible for the commercialization effor
f
ts of the platelet and plasma systems in Europe, the Commonwealth of
Independent States and the Middle East. Product revenues are attributed to each region based on the location of the customer, and in the
case of non-product revenues, on the location of the collaboration partner.

113
The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, dur
d
ing
the years ended December 31, 2024, 2023 and 2022 (in percentages):
Year Ended December 31,
2024
2023
2022
American Red Cross
35%
35%
35%
Établissement Français du S
d
ang
11%
12%
12%
Revenues by geographical location were based on the location of the customer during the years ended December 31, 2024, 2023 and
2022, and was as follows (in thousands):
Year Ended December 31,
2024
2023
2022
Product revenue:
United States
$
111,073
$
93,232
$
101,391
France
19,692
18,490
19,327
Other countries
49,505
44,645
41,330
Total product revenue
180,270
156,367
162,048
Government contract revenue:
United States
21,051
30,430
26,267
Total government contract revenue
21,051
30,430
26,267
Total revenue
$
201,321
$
186,797
$
188,315
Long-lived assets by geographical location at December 31, 2024 and December 31, 2023, were as follows (in thousands):
December 31,
2024
2023
United States
$
6,807
$
8,444
Europe & other
347
196
Total long-lived assets
$
7,154
$
8,640

114
SIGNATURES
Pursuant to the requirement of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto dul
d y authorized, on the 26th day of Februa
r
ry, 2025.
CERUS CORPORAT
R
ION
By:
/s/
WILLIAM M. GREENMAN
A
William M. Greenman
Presiden
d
t and Chief E
e
xe
E
cutive Offi
f cer
Each person whose signature appears below constitutes and appoints William M. Greenman and Kevin D. Green, his or her true and
lawful
f
attorney-in-fact and agent, each acting alone, with ful
f l power of subs
u
titution and resubs
u
titut
t ion, for him or her and in his or her
name, place and stead, in any and all capacities, to sign any or all amendments to the Annual Report on Form 10-K and to file the same,
with all exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said
attorney-in-fact and agent, ful
f l power and authority to do and perform each and every act and thing requisite and necessary to be done
in and about
a
the premises, as ful
f ly to all intents and purpos
r
es as he might or could do in person, hereby ratifyi
f ng and confirming all that
said attorney-in-fact and agent, or his subs
u
titute or subs
u
titutes, may lawfully do or cause to be done by virtue
t
hereof.f
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the fol
f lowing persons on
behalf of the registrant and in the capacities and on the dates indicated.
Signature
g
Title
Date
/s/
WILLIAM M. GREENMAN
A
William M. Greenman
President, Chief Executive
Offi
f cer and Director
(Principal Executive Offic
f
er)r
Februa
r
ry 26, 2025
/s/
KEVIN D. GREEN
Kevin D. Green
Vice President, Finance and
Chief Financial Offi
f cer
(Principal Financial and Accounting Offi
O
cer)r
Februa
r
ry 26, 2025
/s/
DANIEL N. SWISHER, JR.
Daniel N. Swisher, Jr.
Director and Chair of the Board of Directors
Februa
r
ry 26, 2025
/s/
ERIC H. BJERKHOLT
Eric H. Bjerkholt
Director
Februa
r
ry 26, 2025
/s/
DEAN A. GREGORY
Dean A. Gregory
Director
Februa
r
ry 26, 2025
/s/
ANN LUCENA
Ann Lucena
Director
Februa
r
ry 26, 2025
/s/
TIMOTHY L. MOORE
Timothy L. Moore
Director
Februa
r
ry 26, 2025
/s/
JAMI NACHTSHEIM
Jami Nachtsheim
Director
Februa
r
ry 26, 2025
/s/
GAIL SCHULZE
Gail Schulze
Director
Februa
r
ry 26, 2025
/s/
HUA SHAN, MD, PH.D.
Hua Shan, MD, Ph.D.
Director
Februa
r
ry 26, 2025
/s/
FRANK
R
WITNEY, PH.D.
Frank Witney, Ph.D.
Director
Februa
r
ry 26, 2025