Cerus Corporation Announces Third Quarter 2024 Financial Results
Cerus (CERS) reported strong Q3 2024 financial results with product revenue increasing 16% to $46.0 million. The company raised its full-year 2024 product revenue guidance to $177-179 million. Q3 highlights include a new $248 million BARDA contract for INTERCEPT RBCs, expanded U.S. manufacturing capacity for INTERCEPT Fibrinogen Complex, and improved financial metrics with GAAP net loss narrowing to $2.9 million. Product gross margin improved to 56.9%, and the company generated positive operating cash flows of $4.1 million. However, CE Mark review for INTERCEPT RBCs concluded without approval.
Cerus (CERS) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con un aumento del fatturato da prodotto del 16% a 46,0 milioni di dollari. L'azienda ha innalzato le previsioni di fatturato per l'intero anno 2024 a 177-179 milioni di dollari. I punti salienti del terzo trimestre includono un nuovo contratto da 248 milioni di dollari con BARDA per i RBC INTERCEPT, un'espansione della capacità produttiva negli Stati Uniti per il Complesso di Fibrinogeno INTERCEPT e il miglioramento delle metriche finanziarie, con la perdita netta GAAP ridotta a 2,9 milioni di dollari. Il margine lordo sui prodotti è migliorato al 56,9% e l'azienda ha generato flussi di cassa operativi positivi di 4,1 milioni di dollari. Tuttavia, la revisione del marchio CE per i RBC INTERCEPT si è conclusa senza approvazione.
Cerus (CERS) reportó resultados financieros sólidos para el tercer trimestre de 2024, con un aumento del 16% en los ingresos por productos, alcanzando los 46,0 millones de dólares. La compañía elevó su guía de ingresos por productos para todo el año 2024 a entre 177 y 179 millones de dólares. Los aspectos destacados del tercer trimestre incluyen un nuevo contrato de 248 millones de dólares con BARDA para los RBC INTERCEPT, la expansión de la capacidad de fabricación en EE. UU. para el Complejo de Fibrinógeno INTERCEPT y la mejora de los indicadores financieros, con la pérdida neta según GAAP reducida a 2,9 millones de dólares. El margen bruto de productos mejoró al 56,9% y la compañía generó flujos de efectivo operativos positivos de 4,1 millones de dólares. Sin embargo, la revisión de la marca CE para los RBC INTERCEPT concluyó sin aprobación.
세루스 (CERS)는 2024년 3분기 강력한 재무 결과를 보고했으며, 제품 수익이 16% 증가하여 4600만 달러에 이르렀습니다. 이 회사는 2024년 전체 연간 제품 수익 가이드를 1억 7700만 - 1억 7900만 달러로 상향 조정했습니다. 3분기의 주요 사항으로는 INTERCEPT RBCs를 위한 2억4800만 달러 규모의 BARDA 계약, INTERCEPT 피브리노겐 복합체의 미국 내 제조 능력 확장, GAAP 기준 순손실이 290만 달러로 축소된 금융 지표 향상이 있습니다. 제품 총 매출 이익률이 56.9%로 개선되었고, 회사는 410만 달러의 긍정적인 운영 현금 흐름을 생성했습니다. 그러나 INTERCEPT RBCs에 대한 CE 마크 검토는 승인 없이 종료되었습니다.
Cerus (CERS) a annoncé des résultats financiers solides pour le troisième trimestre 2024, avec des revenus produits ayant augmenté de 16% pour atteindre 46,0 millions de dollars. La société a relevé ses prévisions de revenus pour l'ensemble de l'année 2024 à 177-179 millions de dollars. Les points forts du troisième trimestre incluent un nouveau contrat de 248 millions de dollars avec BARDA pour les RBC INTERCEPT, l'expansion de la capacité de production aux États-Unis pour le Complexe de Fibrinogène INTERCEPT et l'amélioration des indicateurs financiers avec une perte nette GAAP réduite à 2,9 millions de dollars. La marge brute des produits a augmenté à 56,9% et l'entreprise a généré des flux de trésorerie opérationnels positifs de 4,1 millions de dollars. Cependant, l'examen de la marque CE pour les RBC INTERCEPT s'est terminé sans approbation.
Cerus (CERS) hat starke Q3 2024 Finanzzahlen berichtet, mit einem Produktumsatz, der um 16% auf 46,0 Millionen Dollar gestiegen ist. Das Unternehmen hat seine Prognose für den gesamten Produktumsatz 2024 auf 177-179 Millionen Dollar angehoben. Zu den Highlights des Q3 gehören ein neuer BARDA-Vertrag über 248 Millionen Dollar für INTERCEPT RBCs, die Erweiterung der Produktionskapazität in den USA für INTERCEPT Fibrinogen-Komplex und verbesserte Finanzkennzahlen, wobei der GAAP-Nettoverlust auf 2,9 Millionen Dollar gesenkt wurde. Die Bruttomarge der Produkte verbesserte sich auf 56,9% und das Unternehmen erwirtschaftete positive operative Cashflows von 4,1 Millionen Dollar. Allerdings wurde die CE-Zertifizierungsprüfung für INTERCEPT RBCs ohne Genehmigung abgeschlossen.
- Product revenue increased 16% YoY to $46.0 million in Q3 2024
- Product gross margin improved to 56.9% from 54.9% YoY
- Generated positive operating cash flows of $4.1 million
- Secured new BARDA contract worth up to $248 million
- Raised full-year 2024 product revenue guidance to $177-179 million
- Narrowed GAAP net loss to $2.9 million from $7.3 million YoY
- CE Mark review for INTERCEPT RBCs concluded without approval
- Government contract revenue decreased 38% to $4.6 million
- $65.0 million outstanding on term loan and $18.5 million drawn on revolving credit facility
Insights
Strong Q3 2024 results showcase significant operational improvements.
Pipeline developments present mixed signals. While the CE Mark rejection for INTERCEPT RBCs is a setback, the expanded U.S. manufacturing capacity for INTERCEPT Fibrinogen Complex through additional BLA approvals strengthens commercial capabilities. The LED illuminator submission in Europe represents a technological advancement that could improve operational efficiency. The new BARDA contract supports RBC program advancement through potential PMA licensure, indicating continued progress in the U.S. market despite European challenges. The completion of the ReCePI Phase 3 trial provides valuable clinical data for future regulatory submissions.
Third Quarter and First Nine-Month Product Revenue Increased
Raising Full-Year 2024 Total Product Revenue Guidance to the Range of
Total revenue for the three and nine months ended September 30, 2024 was comprised of (in thousands, except %):
Three Months Ended |
|
Nine Months Ended |
|||||||||||||||||||||||||||
September 30, |
Change |
|
September 30, |
Change |
|||||||||||||||||||||||||
2024 |
|
2023 |
|
$ |
|
% |
2024 |
|
2023 |
|
$ |
|
% |
||||||||||||||||
Product Revenue |
$ |
46,017 |
$ |
39,772 |
$ |
6,245 |
|
16 |
% |
$ |
129,461 |
$ |
109,599 |
$ |
19,862 |
|
18 |
% |
|||||||||||
Government Contract Revenue |
|
4,639 |
|
|
7,479 |
|
|
(2,840 |
) |
-38 |
% |
|
15,109 |
|
|
23,856 |
|
|
(8,747 |
) |
-37 |
% |
|||||||
Total Revenue |
$ |
50,656 |
|
$ |
47,251 |
|
$ |
3,405 |
|
7 |
% |
$ |
144,570 |
|
$ |
133,455 |
|
$ |
11,115 |
|
8 |
% |
Recent highlights include:
-
Partnered with
U.S. Biomedical Advanced Research and Development Authority (BARDA) for new, six-year contract with value up to designed to support advancement of INTERCEPT® Blood System for Red Blood Cells (RBCs) beyond$248 million U.S. Phase 3 studies through potential PMA licensure and into commercialization. - CE Mark review for INTERCEPT RBCs concluded without approval; assessing strategy for potential future regulatory submission in collaboration with Notified Body, TÜV-SÜD.
-
Further expanded
U.S. manufacturing capacity for INTERCEPT Fibrinogen Complex (IFC) following receipt of three additional biologics license application (BLA) approvals by Cerus IFC production partners. -
Multiple presentations across the INTERCEPT product portfolio at this month’s 2024 Association for Advancement of Blood & Biotherapies (AABB) Annual Meeting, including real-world case studies for IFC and clinical data from the
U.S. Phase 3 ReCePI trial. -
Submitted CE Mark dossier for LED illuminator in
Europe to TÜV-SÜD. -
Narrowed GAAP net loss attributable to Cerus Corporation to
and generated positive non-GAAP adjusted EBITDA of$2.9 million for the third quarter.$4.4 million -
Generated positive operating cash flows for the third straight quarter of 2024 bringing year-to-date positive operating cash flows to
.$6.4 million
“Our performance, both commercially and financially, was very strong for the third quarter,” stated William “Obi” Greenman, Cerus’ president and chief executive officer. “In addition to the organic growth in our North American INTERCEPT platelet business, we are pleased to have secured meaningful additional
“With respect to our development pipeline, we are pleased to have submitted our LED illuminator regulatory filing in
Revenue
Product revenue during the third quarter of 2024 was
Third-quarter 2024 government contract revenue was
Product Gross Profit & Margin
Product gross profit for the third quarter of 2024 was
Operating Expenses
Total operating expenses for the third quarter of 2024 were
R&D expenses for the third quarter of 2024 were
SG&A expenses for the third quarter of 2024 were
Net Loss Attributable to Cerus Corporation
Net loss attributable to Cerus Corporation for the third quarter of 2024 was
Non-GAAP Adjusted EBITDA
Non-GAAP adjusted EBITDA for the third quarter of 2024 was a positive
Balance Sheet & Cash Flows
At September 30, 2024, the Company had cash and cash equivalents and short-term investments of
As of September 30, 2024, the Company had
For the third quarter of 2024, the Company generated positive cash flows of
Raising 2024 Product Revenue Guidance
The Company is raising its full-year 2024 product revenue guidance to a range of
Quarterly Conference Call
The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
A replay will be available on Cerus’ website approximately three hours after the call through November 20, 2024.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward-Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to: Cerus’ 2024 annual product revenue guidance and its belief in its ability to achieve its full-year 2024 goals; Cerus’ expectation for full-year 2024 non-GAAP adjusted EBITDA breakeven; Cerus’ expectations with respect to product revenue gross margin levels in 2024; the potential value of and funding opportunity under the new BARDA agreement and Cerus’ expectations with respect to activities intended to be funded under the new BARDA agreement; the potential premarket approval (PMA) licensure of and commercialization of INTERCEPT RBCs; the potential for Cerus to submit an expanded new regulatory submission for the INTERCEPT RBC system in
Use of Non-GAAP Financial Measures
We define adjusted EBITDA as net loss attributable to Cerus Corporation as reported on the consolidated statement of operations, as adjusted to exclude, as applicable for the reporting period(s) presented, (i) net loss attributable to noncontrolling interest, (ii) provision for income taxes, (iii) foreign exchange (loss)/gain, (iv) interest income (expense), (v) other income (expense), net, (vi) depreciation and amortization, (vii) share-based compensation, (viii) goodwill and asset impairments, (ix) costs associated with our noncontrolling interest in our joint venture in
Investors should note that Cerus has not provided a reconciliation of anticipated non-GAAP adjusted EBITDA for the year ending December 31, 2024 to projected GAAP net loss attributable to Cerus Corporation for the year ending December 31, 2024 because certain items such as share-based compensation that are components of GAAP net loss attributable to Cerus Corporation cannot be reasonably projected due to the significant impact of changes in Cerus’ stock price and other factors. These components of GAAP net loss attributable to Cerus Corporation could significantly impact the reported GAAP net loss attributable to Cerus Corporation.
Supplemental Tables
|
Three Months Ended |
Nine Months Ended |
|
September 30, |
September 30, |
|
2024 vs. 2023 |
2024 vs. 2023 |
Platelet Kit Growth |
|
|
|
|
|
International |
|
|
Worldwide |
|
|
|
|
|
Change in Calculated Number of Treatable Platelet Doses |
|
|
|
|
|
International |
|
|
Worldwide |
|
|
* Dose treatable calculation based on the number of kits sold and the product configuration (single, double, and triple dose kits) |
CERUS CORPORATION REVENUE BY REGION (in thousands, except percentages) |
|||||||||||||||||||||||||||||
|
Three Months Ended |
|
|
|
|
|
Nine Months Ended |
|
|
|
|
||||||||||||||||||
|
September 30, |
|
Change |
|
September 30, |
|
Change |
||||||||||||||||||||||
|
2024 |
|
2023 |
|
$ |
|
% |
|
2024 |
|
2023 |
|
$ |
|
% |
||||||||||||||
|
$ |
31,514 |
|
$ |
25,983 |
|
$ |
5,531 |
|
21 |
% |
|
$ |
87,783 |
|
$ |
67,077 |
|
$ |
20,706 |
|
|
31 |
% |
|||||
|
|
13,807 |
|
|
|
13,614 |
|
|
|
193 |
|
|
1 |
% |
|
|
40,246 |
|
|
|
41,175 |
|
|
|
(929 |
) |
|
-2 |
% |
Other |
|
696 |
|
|
|
175 |
|
|
|
521 |
|
|
298 |
% |
|
|
1,432 |
|
|
|
1,347 |
|
|
|
85 |
|
|
6 |
% |
Total product revenue |
$ |
46,017 |
|
|
$ |
39,772 |
|
|
$ |
6,245 |
|
|
16 |
% |
|
$ |
129,461 |
|
|
$ |
109,599 |
|
|
$ |
19,862 |
|
|
18 |
% |
CERUS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except per share data) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
September 30, |
September 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Product revenue |
$ |
46,017 |
|
$ |
39,772 |
|
$ |
129,461 |
|
$ |
109,599 |
|
||||
Cost of product revenue |
|
19,818 |
|
|
17,956 |
|
|
57,324 |
|
|
49,158 |
|
||||
Gross profit on product revenue |
|
26,199 |
|
|
21,816 |
|
|
72,137 |
|
|
60,441 |
|
||||
Government contract revenue |
|
4,639 |
|
|
7,479 |
|
|
15,109 |
|
|
23,856 |
|
||||
Operating expenses: |
||||||||||||||||
Research and development |
|
14,013 |
|
|
16,783 |
|
|
43,464 |
|
|
53,351 |
|
||||
Selling, general and administrative |
|
17,786 |
|
|
16,155 |
|
|
56,558 |
|
|
58,247 |
|
||||
Restructuring |
|
- |
|
|
1,600 |
|
|
- |
|
|
3,728 |
|
||||
Total operating expenses |
|
31,799 |
|
|
34,538 |
|
|
100,022 |
|
|
115,326 |
|
||||
Loss from operations |
|
(961 |
) |
|
(5,243 |
) |
|
(12,776 |
) |
|
(31,029 |
) |
||||
Total non-operating expense, net |
|
(1,897 |
) |
|
(1,965 |
) |
|
(5,529 |
) |
|
(4,976 |
) |
||||
Loss before income taxes |
|
(2,858 |
) |
|
(7,208 |
) |
|
(18,305 |
) |
|
(36,005 |
) |
||||
Provision for income taxes |
|
76 |
|
|
78 |
|
|
94 |
|
|
253 |
|
||||
Net loss |
|
(2,934 |
) |
|
(7,286 |
) |
|
(18,399 |
) |
|
(36,258 |
) |
||||
Net loss attributable to noncontrolling interest |
|
- |
|
|
(19 |
) |
|
(2 |
) |
|
(97 |
) |
||||
Net loss attributable to Cerus Corporation |
$ |
(2,934 |
) |
$ |
(7,267 |
) |
$ |
(18,397 |
) |
$ |
(36,161 |
) |
||||
Net loss per share attributable to Cerus Corporation: |
||||||||||||||||
Basic and diluted |
$ |
(0.02 |
) |
$ |
(0.04 |
) |
$ |
(0.10 |
) |
$ |
(0.20 |
) |
||||
Weighted average shares outstanding: |
||||||||||||||||
Basic and diluted |
|
185,424 |
|
|
180,938 |
|
|
184,170 |
|
|
179,950 |
|
CERUS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
||||||||
September 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
ASSETS |
(unaudited) |
|||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
21,575 |
$ |
11,647 |
||||
Short-term investments |
|
53,990 |
|
|
54,205 |
|
||
Accounts receivable, net |
|
24,361 |
|
|
35,500 |
|
||
Current inventories |
|
36,538 |
|
|
39,868 |
|
||
Prepaid and other current assets |
|
4,148 |
|
|
3,221 |
|
||
Total current assets |
|
140,612 |
|
|
144,441 |
|
||
Non-current assets: |
||||||||
Property and equipment, net |
|
7,437 |
|
|
8,640 |
|
||
Operating lease right-of-use assets |
|
8,936 |
|
|
10,713 |
|
||
Goodwill |
|
1,316 |
|
|
1,316 |
|
||
Non-current inventories |
|
14,811 |
|
|
19,501 |
|
||
Other assets and restricted cash |
|
16,427 |
|
|
13,137 |
|
||
Total assets |
$ |
189,539 |
|
$ |
197,748 |
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable and accrued liabilities |
$ |
31,743 |
|
$ |
43,067 |
|
||
Debt – current |
|
18,521 |
|
|
20,000 |
|
||
Operating lease liabilities – current |
|
2,260 |
|
|
2,452 |
|
||
Deferred revenue – current |
|
1,821 |
|
|
2,002 |
|
||
Total current liabilities |
|
54,345 |
|
|
67,521 |
|
||
Non-current liabilities: |
||||||||
Debt – non-current |
|
64,847 |
|
|
59,796 |
|
||
Operating lease liabilities – non-current |
|
12,270 |
|
|
13,751 |
|
||
Other non-current liabilities |
|
3,796 |
|
|
3,236 |
|
||
Total liabilities |
|
135,258 |
|
|
144,304 |
|
||
Stockholders' equity: |
|
53,489 |
|
|
52,650 |
|
||
Noncontrolling interest |
|
792 |
|
|
794 |
|
||
Total liabilities and stockholders' equity |
$ |
189,539 |
|
$ |
197,748 |
|
CERUS CORPORATION UNAUDITED RECONCILIATION OF NON-GAAP ADJUSTED EBITDA (in thousands) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
September 30 |
September 30 |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Net loss attributable to Cerus Corporation |
$ |
(2,934 |
) |
$ |
(7,267 |
) |
$ |
(18,397 |
) |
$ |
(36,161 |
) |
||||
Adjustments to net loss attributable to Cerus Corporation: |
||||||||||||||||
Net loss attributable to noncontrolling interest |
|
- |
|
|
(19 |
) |
|
(2 |
) |
|
(97 |
) |
||||
Provision for income taxes |
|
76 |
|
|
78 |
|
|
94 |
|
|
253 |
|
||||
Total non-operating expense, net (i) |
|
1,897 |
|
|
1,965 |
|
|
5,529 |
|
|
4,976 |
|
||||
Loss from operations |
|
(961 |
) |
|
(5,243 |
) |
|
(12,776 |
) |
|
(31,029 |
) |
||||
Adjustments to loss from operations: |
||||||||||||||||
Operating depreciation and amortization |
|
1,120 |
|
|
1,143 |
|
|
3,464 |
|
|
3,313 |
|
||||
Government contract revenue (ii) |
|
(4,639 |
) |
|
(7,479 |
) |
|
(15,109 |
) |
|
(23,856 |
) |
||||
Direct expenses attributable to government contracts (iii) |
|
3,038 |
|
|
4,991 |
|
|
9,513 |
|
|
16,800 |
|
||||
Share-based compensation (iv) |
|
5,830 |
|
|
3,979 |
|
|
17,363 |
|
|
15,368 |
|
||||
Costs attributable to noncontrolling interest (v) |
|
- |
|
|
37 |
|
|
3 |
|
|
210 |
|
||||
Restructuring (vi) |
|
- |
|
|
1,600 |
|
|
- |
|
|
3,728 |
|
||||
Non-GAAP adjusted EBITDA |
$ |
4,388 |
|
$ |
(972 |
) |
$ |
2,458 |
|
$ |
(15,466 |
) |
||||
i. Includes interest income/expense and foreign exchange gains/losses. |
||||||||||||||||
ii. Represents revenue related to the cost reimbursement provisions under our government contracts. |
||||||||||||||||
iii. Represents the direct expenses attributable to work supporting government contracts, which are reimbursed and reflected under government contract revenue in the condensed consolidated statement of operations. |
||||||||||||||||
iv. Represents non-cash stock-based compensation. |
||||||||||||||||
v. Represents costs associated with the noncontrolling interest in Cerus Zhongbaokang ( |
||||||||||||||||
vi. Represents costs associated with the Company’s restructuring plan implemented in June 2023. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241030751950/en/
Jessica Hanover
Cerus Corporation
925-288-6137
Source: Cerus Corporation
FAQ
What was Cerus 's (CERS) Q3 2024 product revenue?
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