CONCORD, Calif.–(BUSINESS WIRE)–Cerus Corporation (Nasdaq: CERS) today appear banking after-effects for the third division concluded September 30, 2021.
Recent developments and highlights include:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
Change
2021
2020
Change
Product revenue
$
36,131
23,607
53
%
$
90,994
63,721
43
%
Government arrangement revenue
5,970
5,584
7
%
18,436
16,938
9
%
Total revenue
$
42,101
29,191
44
%
$
109,430
80,659
36
%
“Cerus’ third division after-effects represent a able bartering accomplishment for the Company, in accurate with attention to the U.S. platelet business. With anniversary artefact acquirement of $36.1 actor and sales drive that continues into the fourth quarter, I am admiring that accepting of the INTERCEPT Claret Arrangement for platelets is establishing a new accepted of care,” said William ‘Obi’ Greenman, Cerus’ admiral and arch controlling officer. “With solid afterimage to connected appeal for the antithesis of the year, we are adopting our artefact acquirement advice and attending advanced to finishing this blemish year for Cerus on a able note.”
Revenue
Product acquirement during the third division of 2021 was $36.1 million, compared to $23.6 actor during the aforementioned aeon in 2020. Artefact acquirement beforehand during the division was apprenticed by added sales of INTERCEPT platelet articles to claret centermost barter beyond the U.S.
Third division government arrangement acquirement was $6.0 million, compared to $5.6 actor during the aforementioned aeon in 2020. Third division government arrangement acquirement was comprised of allotment associated with analysis and development (R&D) activities accompanying to the INTERCEPT Claret Arrangement for Red Cells as able-bodied as sponsored efforts accompanying to the development of abutting bearing antibody abridgement technology to amusement accomplished blood.
Product Gross Accumulation & Margin
Product gross accumulation for the third division 2021 was $18.5 actor and was the accomplished in aggregation history, absorption a about $6 actor admission over the aforementioned aeon in 2020. Artefact gross allowance for the third division 2021 was 51.3% compared to 53.6% for the third division of 2020 and collapsed compared to the added division of 2021. The advancing abatement in artefact gross allowance compared to the third division of 2020 was angry to college sales to U.S. barter during the quarter, who at present, primarily use the Company’s distinct dosage platelet kits, which accommodate a lower artefact gross allowance allotment compared to our bifold dosage kits that are added frequently acclimated internationally.
Operating Expenses
Total operating costs for the third division of 2021 were $35.6 actor compared to $32.2 actor for the aforementioned aeon of the above-mentioned year. In general, the admission in operating costs compared to the above-mentioned year aeon were apprenticed by college bartering expenses, due to sales allurement advantage and partially account by lower R&D expenses.
Selling, general, and authoritative (SG&A) costs for the third division of 2021 totaled $20.4 million, compared to $16.3 actor for the third division of 2020. The year-over-year admission in SG&A costs was angry to added sales costs and connected investments in our analysis business unit.
R&D costs for the third division of 2021 were $15.3 million, compared to $15.9 actor for the third division of 2020. Connected investments in a array of R&D activity projects connected during the quarter, including those accompanying to the Company’s LED illuminator, but were account by lower R&D costs against the above-mentioned year aeon associated with complete projects that accept been completed.
Net Accident Attributable to Cerus Corporation
Net accident attributable to Cerus Corporation for the third division of 2021 was $12.4 million, or $0.07 per basal and adulterated share, compared to a net accident attributable to Cerus Corporation of $14.1 million, or $0.08 per basal and adulterated share, for the third division of 2020.
Balance Sheet
At September 30, 2021, the Aggregation had cash, banknote equivalents and concise investments of $120.0 million, compared to $122.8 actor at June 30, 2021 and $133.6 actor at December 31, 2020. Despite connected investments in account to accommodated the advancing beforehand in demand, banknote acclimated from operations connected to abatement as the Aggregation accomplished added acquirement accession and cogent advantage in SG&A spend.
As of September 30, 2021, the Aggregation agitated $55 actor of addendum due and a antithesis on its revolving band of acclaim of $10 million. The Aggregation continues to accept admission to accession $15 actor beneath its appellation adeptness and accommodation for an added $10 actor beneath its revolving band of credit.
Increasing 2021 Artefact Acquirement Guidance
Based on the able artefact acquirement year to date and adapted appeal estimates branch into the butt of the Company’s fourth quarter, the Aggregation now expects 2021 artefact acquirement to be in the ambit of $127 actor to $129 million, compared to the above-mentioned ambit of $118 actor to $122 million. The revised advice ambit represents about 38% to 40% beforehand over 2020 appear artefact revenue.
Quarterly Appointment Call
The Aggregation will host a appointment alarm at 4:30 P.M. EDT this afternoon, during which administration will altercate the Company’s banking after-effects and accommodate a accepted business overview and outlook. To accept to the alive webcast, amuse appointment the Investor Relations folio of the Cerus website at http://www.cerus.com/ir. Alternatively, you may admission the alive appointment alarm by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).
A epitomize will be accessible on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering appointment ID cardinal 3970817. The epitomize will be accessible about three hours afterwards the alarm through November 16, 2021.
ABOUT CERUS
Cerus Corporation is committed alone to attention the world’s claret accumulation and aims to become the basic all-around claret articles company. Headquartered in Concord, California, the aggregation develops and food basic technologies and pathogen-protected claret apparatus to claret centers, hospitals, and ultimately patients who await on safe blood. The INTERCEPT Claret Arrangement for platelets and claret is accessible globally and charcoal the alone antibody abridgement arrangement with both CE Mark and FDA approval for these two claret components. The INTERCEPT red claret corpuscle arrangement is beneath authoritative analysis in Europe, and in late-stage analytic development in the US. Additionally in the US, the INTERCEPT Claret Arrangement for Cryoprecipitation is accustomed for the assembly of INTERCEPT Fibrinogen Complex, a ameliorative artefact for the analysis and ascendancy of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For added advice about Cerus, appointment www.cerus.com and chase us on LinkedIn.
INTERCEPT and the INTERCEPT Claret Arrangement are trademarks of Cerus Corporation.
Forward Looking Statements
Except for the actual statements independent herein, this columnist absolution contains advanced statements apropos Cerus’ products, affairs and accepted results, including statements apropos to Cerus’ adapted 2021 anniversary artefact acquirement guidance, including Cerus’ apprehension of connected appeal for the antithesis of 2021; Cerus establishing the INTERCEPT Claret Arrangement as a accepted of care; Cerus’ adeptness to admission added allotment beneath its appellation accommodation adeptness and revolving band of credit; and added statements that are not actual fact. Actual after-effects could alter materially from these advanced statements as a aftereffect of assertive factors, including, after limitation: risks associated with the commercialization and bazaar accepting of, and chump appeal for, the INTERCEPT Claret System, including the risks that Cerus may not (a) accommodated its adapted 2021 anniversary artefact acquirement guidance, (b) finer barrage and commercialize the INTERCEPT Claret Arrangement for Cryoprecipitation, (c) abound sales globally, including in its U.S. and European markets, and/or apprehend accepted acquirement accession consistent from its U.S. and European bazaar agreements, (d) apprehend allusive and/or accretion acquirement contributions from U.S. barter in the abreast appellation or at all, decidedly back Cerus cannot acceding the aggregate or timing of bartering purchases, if any, that its U.S. barter may accomplish beneath Cerus’ bartering agreements with these customers, (e) finer aggrandize its commercialization activities into added geographies and/or (f) apprehend any acquirement accession from its activity artefact candidates, whether due to Cerus’ disability to admission authoritative approval of its activity programs, or otherwise; risks associated with the ultimate continuance and severity of the COVID-19 communicable and consistent all-around bread-and-butter and banking disruptions, and the accepted and abeyant approaching abrogating impacts to Cerus’ business operations and banking after-effects such as the accepted and abeyant added disruptions to the U.S. and EMEA claret accumulation consistent from the evolving furnishings of the COVID-19 pandemic; risks associated with Cerus’ abridgement of commercialization acquaintance with the INTERCEPT Claret Arrangement for Cryoprecipitation and in the United States generally, and its adeptness to beforehand and beforehand an able and able U.S.-based bartering organization, as able-bodied as the consistent ambiguity of its adeptness to accomplish bazaar accepting of and contrarily auspiciously commercialize the INTERCEPT Claret Arrangement in the United States, including as a aftereffect of licensure requirements that charge be annoyed by U.S. barter above-mentioned to their agreeable in artery carriage of claret apparatus candy application the INTERCEPT Claret System; risks accompanying to Fresenius Kabi’s efforts to assure an ceaseless accumulation of platelet accretion band-aid (PAS); risks accompanying to how any approaching PAS accumulation disruption could affect INTERCEPT’s accepting in the marketplace; risks accompanying to how any approaching PAS accumulation disruption adeptness affect accepted bartering contracts; risks accompanying to Cerus’ adeptness to authenticate to the admixture anesthetic association and added bloom affliction constituencies that antibody reduction, including INTERCEPT Fibrinogen Complex for the analysis and ascendancy of bleeding, and the INTERCEPT Claret Arrangement is safe, able and economical; risks accompanying to the ambiguous and time- arresting development and authoritative process, including the risks that (a) Cerus may be clumsy to accede with the FDA’s post-approval requirements for the INTERCEPT Claret System, including by auspiciously commutual appropriate post-approval studies, which could aftereffect in a accident of U.S. business approval(s) for the INTERCEPT Claret System, (b) accomplishment armpit Biologics License Applications all-important for Cerus to administer the INTERCEPT Claret Arrangement for Cryoprecipitation may not be acquired in a appropriate address or at all, and (c) Cerus may be clumsy to admission the requisite authoritative approvals to beforehand its activity programs and accompany them to bazaar in a appropriate address or at all; risks associated with the ambiguous attributes of BARDA’s allotment over which Cerus has no ascendancy as able-bodied as accomplishments of Congress and authoritative agencies that may abnormally affect the availability of allotment beneath Cerus’ BARDA acceding and/or BARDA’s exercise of any abeyant consecutive advantage periods, including in affiliation with the accepted bread-and-butter ambiance and ambiguity associated with the evolving furnishings of the COVID-19 pandemic, such that the advancing activities that Cerus expects to conduct with the funds accessible from BARDA may be added delayed or apoplectic and that Cerus may not contrarily apprehend the absolute abeyant amount beneath its acceding with BARDA; risks accompanying to artefact safety, including the accident that the catchbasin platelet transfusions may not be accidental with the INTERCEPT Claret System; risks accompanying to adverse bazaar and bread-and-butter conditions, including connected or added astringent adverse fluctuations in adopted barter ante and/or connected or added astringent abrasion in bread-and-butter altitude consistent from the evolving furnishings of the COVID-19 communicable or contrarily in the markets area Cerus currently sells and is advancing to advertise its products; Cerus’ assurance on third parties to market, sell, administer and beforehand its products; Cerus’ adeptness to beforehand an effective, defended accomplishment accumulation chain, including the risks that (a) Cerus’ accumulation alternation could be abnormally impacted as a aftereffect of the evolving furnishings of the COVID-19 pandemic, (b) Cerus’ manufacturers could be clumsy to accede with all-encompassing FDA and adopted authoritative bureau requirements, and (c) Cerus may be clumsy to beforehand its primary kit accomplishment acceding and its added accumulation agreements with its third affair suppliers; Cerus’ adeptness to analyze and admission added ally to accomplish the INTERCEPT Claret Arrangement for Cryoprecipitation; risks associated with Cerus’ adeptness to admission added funds beneath its appellation accommodation adeptness and revolving band of acclaim and to accommodated its debt account obligations, and its charge for added funding; the appulse of aldermanic or authoritative healthcare reforms that may accomplish it added difficult and cher for Cerus to produce, bazaar and administer its products; risks accompanying to approaching opportunities and plans, including the ambiguity of Cerus’ approaching basic requirements and its approaching revenues and added banking achievement and results, as able-bodied as added risks abundant in Cerus’ filings with the Securities and Barter Commission, including beneath the branch “Risk Factors” in Cerus’ Anniversary Report on Form 10-Q, filed with the SEC on August 3, 2021, and approaching filings and letters by Cerus. In addition, to the admeasurement that the COVID-19 communicable abnormally affects Cerus’ business and banking results, it may additionally accept the aftereffect of deepening abounding of the added risks and uncertainties declared above. Cerus disclaims any obligation or adventure to amend or alter any advanced statements independent in this columnist release.
Supplemental Tables
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021 vs. 2020
2021 vs. 2020
Platelet Kit Growth
U.S.
168%
127%
International
5%
5%
Worldwide
82%
58%
Change in Calculated Cardinal of Treatable Platelet Doses*
U.S.
162%
124%
International
5%
5%
Worldwide
69%
50%
* Dosage treatable adding based on the cardinal of kits awash and the artefact agreement (single, double, and amateur dosage kits)
CERUS CORPORATION
REVENUE BY REGION
(in thousands, except percentages)
Three Months Ended
Nine Months Ended
September 30,
Change
September 30,
Change
2021
2020
$
%
2021
2020
$
%
North America
$
20,860
$
8,465
$
12,395
146
%
$
45,171
$
20,942
$
24,229
116
%
Europe, Middle East and Africa
14,965
14,527
438
3
%
44,473
41,210
3,263
8
%
Other
306
615
(309
)
-50
%
1,350
1,569
(219
)
-14
%
Total artefact revenue
$
36,131
$
23,607
$
12,524
53
%
$
90,994
$
63,721
$
27,273
43
%
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands, except per allotment information)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Product revenue
$
36,131
$
23,607
$
90,994
$
63,721
Cost of artefact revenue
17,582
10,953
44,000
28,978
Gross accumulation on artefact revenue
18,549
12,654
46,994
34,743
Government arrangement revenue
5,970
5,584
18,436
16,938
Operating expenses:
Research and development
15,288
15,921
48,119
47,349
Selling, accepted and administrative
20,357
16,299
59,285
48,324
Total operating expenses
35,645
32,220
107,404
95,673
Loss from operations
(11,126
)
(13,982
)
(41,974
)
(43,992
)
Total non-operating expense, net
(1,238
)
(89
)
(3,033
)
(1,292
)
Loss afore assets taxes
(12,364
)
(14,071
)
(45,007
)
(45,284
)
Provision for assets taxes
73
68
248
192
Net loss
(12,437
)
(14,139
)
(45,255
)
(45,476
)
Net accident attributable to noncontrolling interest
–
–
–
–
Net accident attributable to Cerus Corporation
$
(12,437
)
$
(14,139
)
$
(45,255
)
$
(45,476
)
Net accident per allotment attributable to Cerus Corporation:
Basic and diluted
$
(0.07
)
$
(0.08
)
$
(0.27
)
$
(0.28
)
Weighted boilerplate shares outstanding:
Basic and diluted
171,904
166,572
170,666
162,800
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
September 30,
December 31,
2021
2020
ASSETS
(unaudited)
Current assets:
Cash and banknote equivalents
$
78,460
$
36,594
Short-term investments
41,501
97,000
Accounts receivable
22,439
21,166
Current inventories
29,420
23,254
Prepaid and added accepted assets
6,232
5,417
Total accepted assets
178,052
183,431
Non-current assets:
Property and equipment, net
12,684
13,867
Goodwill
1,316
1,316
Operating charter right-of-use assets
12,409
13,122
Other assets
14,485
9,679
Total assets
$
218,946
$
221,415
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$
52,371
$
48,966
Debt – current
9,986
8,516
Operating charter liabilities – current
1,616
1,915
Deferred artefact acquirement – current
744
577
Total accepted liabilities
64,717
59,974
Non-current liabilities:
Debt – non-current
54,675
39,588
Operating charter liabilities – non-current
16,079
16,873
Other non-current liabilities
2,400
1,174
Total liabilities
137,871
117,609
Cerus Corporation stockholders’ equity
80,075
103,806
Noncontrolling interest
1,000
–
Total liabilities and stockholders’ equity
$
218,946
$
221,415
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