Cerus Corporation Announces Third Quarter 2024 Financial Results
Third Quarter and First Nine-Month Product Revenue Increased 16% and 18%, respectively from Prior Year Periods
Raising Full-Year 2024 Total Product Revenue Guidance to the Range of
Total revenue for the three and nine months ended
Three Months Ended |
|
Nine Months Ended |
|||||||||||||||||||||||||||
|
Change |
|
|
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$248 million designed to support advancement of INTERCEPT® Blood System for Red Blood Cells (RBCs) beyondU.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 forINTERCEPT 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 theU.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$2.9 million and generated positive non-GAAP adjusted EBITDA of$4.4 million for the third quarter. -
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
Net loss attributable to
Non-GAAP Adjusted EBITDA
Non-GAAP adjusted EBITDA for the third quarter of 2024 was a positive
Balance Sheet & Cash Flows
At
As of
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
A replay will be available on Cerus’ website approximately three hours after the call through
ABOUT
INTERCEPT and the INTERCEPT Blood System are trademarks of
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
Use of Non-GAAP Financial Measures
We define adjusted EBITDA as net loss attributable to
Investors should note that
Supplemental Tables
|
Three Months Ended |
Nine Months Ended |
|
|
|
|
2024 vs. 2023 |
2024 vs. 2023 |
Platelet Kit Growth |
|
|
|
18% |
24% |
International |
1% |
1% |
Worldwide |
13% |
14% |
|
|
|
Change in Calculated Number of Treatable Platelet Doses |
|
|
|
21% |
28% |
International |
0% |
3% |
Worldwide |
14% |
19% |
* Dose treatable calculation based on the number of kits sold and the product configuration (single, double, and triple dose kits) |
REVENUE BY REGION (in thousands, except percentages) |
|||||||||||||||||||||||||||||
|
Three Months Ended |
|
|
|
|
|
Nine Months Ended |
|
|
|
|
||||||||||||||||||
|
|
|
Change |
|
|
|
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 |
% |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except per share data) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
|
|||||||||||||||
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 |
$ |
(2,934 |
) |
$ |
(7,267 |
) |
$ |
(18,397 |
) |
$ |
(36,161 |
) |
||||
Net loss per share attributable to |
||||||||||||||||
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 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
||||||||
|
|
|||||||
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 |
|
||
|
|
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 |
|
UNAUDITED RECONCILIATION OF NON-GAAP ADJUSTED EBITDA (in thousands) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
|
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
Net loss attributable to |
$ |
(2,934 |
) |
$ |
(7,267 |
) |
$ |
(18,397 |
) |
$ |
(36,161 |
) |
||||
Adjustments to net loss attributable to |
||||||||||||||||
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 |
||||||||||||||||
vi. Represents costs associated with the Company’s restructuring plan implemented in |
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