Cerus Corporation Announces Second Quarter 2023 Financial Results
Recent highlights include:
-
Second quarter 2023 total revenue of
was comprised of total product revenue of$47.7 million and government contract revenue of$38.9 million .$8.9 million - Received positive feedback for INTERCEPT Red Blood Cells CE Mark submission in clarification meeting with EU competent authority, the Dutch Medicines Evaluation Board (CBG), supporting possible CE Mark approval decision under the EU Medical Device Regulation (MDR) in the second half of 2024.
- Planned completion of Phase 3 ReCePI study enrollment in cardiovascular surgery patients this year, with top-line data readout expected in Q1 2024.
-
Awarded an additional
in funding from the$8.7 million U.S. Department of Defense for continued development of lyophilized INTERCEPT Fibrinogen Complex (LyoIFC), increasing total contract value to .$17.8 million -
Adjusting full-year 2023 annual product revenue guidance to the range of
to$160 million from the prior range of$165 million to$165 million given the expected impact of a temporary reduction in$170 million U.S. platelet kit shelf life on customer ordering patterns, reduced platelet collections in key regions of EMEA, and newRussia sanctions. -
Cash, cash equivalents, and short-term investments were
at June 30, 2023.$84.5 million
“We are pleased with our recent progress for the INTERCEPT Red Blood Cell program in both the EU and U.S.,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “During the second quarter, we gained additional clarity to a potential CE Mark approval decision in the second half of 2024 and a top-line data readout from our
“On the commercial front, with many of the challenges of the first half of the year behind us, we remain confident in our expectations for growth during the rest of this year and into 2024. We also continue to be committed to achieving adjusted EBITDA breakeven this year,” continued Greenman. “Given some recent ordering pattern modifications related to a temporary INTERCEPT kit shelf-life change in the
Revenue
Product revenue during the second quarter of 2023 was
Second-quarter 2023 government contract revenue was
Product Gross Profit & Margin
Product gross profit for the second quarter of 2023 was
Operating Expenses
Total operating expenses for the second quarter of 2023 were
Selling, general, and administrative (SG&A) expenses for the second quarter of 2023 totaled
R&D expenses for the second quarter of 2023 were
In order to align operating expenses with the operating environment and priority initiatives, the Company entered into a plan to restructure certain functions and reduce its real estate footprint during the most recently completed quarter. The plan resulted in a
Net Loss Attributable to Cerus Corporation
Net loss attributable to Cerus Corporation for the second quarter of 2023 was
Non-GAAP Adjusted EBITDA
Non-GAAP Adjusted EBITDA for the second quarter of 2023 was negative
Balance Sheet & Cash Use
At June 30, 2023, the Company had cash, cash equivalents and short-term investments of
As of June 30, 2023, the Company had
For the second quarter of 2023, net cash used in operating activities totaled
2023 Product Revenue Guidance
The Company is adjusting its previously stated product revenue guidance range. The Company expects full-year 2023 product revenue to be in the 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 August 16, 2023.
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’ updated 2023 annual product revenue guidance; the potential completion of INTERCEPT Red Blood Cell CE Mark submission review in 2023 and a possible CE Mark approval decision under the MDR in the second half of 2024; the planned completion of enrollment in the Phase 3 ReCePI study in 2023 and Cerus’ expectation of a top-line data readout in the first quarter of 2024; Cerus’ plan to begin a modular PMA submission to FDA for the INTERCEPT Red Blood Cell system in the second half of 2025, with a final PMA module submission planned for the second half of 2026; Cerus’ expectations for growth during the rest of 2023 and into 2024, including its expectation that new customers and new geographies will fuel growth going forward; Cerus’ ability to achieve adjusted EBITDA breakeven in 2023; Cerus’ estimate that its restructuring plan will result in annualized operating expense savings of approximately
Use of Non-GAAP Financial Measures
Cerus has presented in this release certain financial information in accordance with
Supplemental Tables
|
Three Months Ended |
Six Months Ended |
June 30, |
June 30, |
|
2023 vs. 2022 |
2023 vs. 2022 |
|
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 |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||||
|
June 30, |
|
Change |
|
June 30, |
|
Change |
||||||||||||||||||
|
|
2023 |
|
|
2022 |
|
$ |
|
% |
|
|
2023 |
|
|
2022 |
|
$ |
|
% |
||||||
|
$ |
24,477 |
|
$ |
25,579 |
|
$ |
(1,102 |
) |
|
-4 |
% |
|
$ |
41,094 |
|
$ |
47,777 |
|
$ |
(6,683 |
) |
|
-14 |
% |
|
|
13,533 |
|
|
14,898 |
|
|
(1,365 |
) |
|
-9 |
% |
|
|
27,561 |
|
|
29,700 |
|
|
(2,139 |
) |
|
-7 |
% |
Other |
|
843 |
|
|
522 |
|
|
321 |
|
|
61 |
% |
|
|
1,172 |
|
|
966 |
|
|
206 |
|
|
21 |
% |
Total product revenue |
$ |
38,853 |
|
$ |
40,999 |
|
$ |
(2,146 |
) |
|
-5 |
% |
|
$ |
69,827 |
|
$ |
78,443 |
|
$ |
(8,616 |
) |
|
-11 |
% |
CERUS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except per share information) |
|||||||||||||||||
|
|
|
|
|
|||||||||||||
|
|
Three Months Ended |
|
Six Months Ended |
|||||||||||||
|
|
June 30, |
|
June 30, |
|||||||||||||
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Product revenue |
$ |
38,853 |
|
$ |
40,999 |
|
$ |
69,827 |
|
$ |
78,443 |
|
|||||
Cost of product revenue |
|
17,515 |
|
|
19,718 |
|
|
31,202 |
|
|
37,794 |
|
|||||
Gross profit on product revenue |
|
21,338 |
|
|
21,281 |
|
|
38,625 |
|
|
40,649 |
|
|||||
Government contract revenue |
|
8,875 |
|
|
6,632 |
|
|
16,377 |
|
|
12,208 |
|
|||||
Operating expenses: |
|||||||||||||||||
Research and development |
|
19,184 |
|
|
15,216 |
|
|
36,568 |
|
|
29,273 |
|
|||||
Selling, general and administrative |
|
20,541 |
|
|
19,532 |
|
|
42,092 |
|
|
40,267 |
|
|||||
Restructuring |
|
2,128 |
|
|
— |
|
|
2,128 |
|
|
— |
|
|||||
Total operating expenses |
|
41,853 |
|
|
34,748 |
|
|
80,788 |
|
|
69,540 |
|
|||||
Loss from operations |
|
(11,640 |
) |
|
(6,835 |
) |
|
(25,786 |
) |
|
(16,683 |
) |
|||||
Total non-operating expense, net |
|
(1,593 |
) |
|
(1,482 |
) |
|
(3,011 |
) |
|
(3,842 |
) |
|||||
Loss before income taxes |
|
(13,233 |
) |
|
(8,317 |
) |
|
(28,797 |
) |
|
(20,525 |
) |
|||||
Provision for income taxes |
|
98 |
|
|
78 |
|
|
175 |
|
|
154 |
|
|||||
Net loss |
|
(13,331 |
) |
|
(8,395 |
) |
|
(28,972 |
) |
|
(20,679 |
) |
|||||
Net loss attributable to noncontrolling interest |
|
(56 |
) |
|
(6 |
) |
|
(78 |
) |
|
(6 |
) |
|||||
Net loss attributable to Cerus Corporation |
$ |
(13,275 |
) |
$ |
(8,389 |
) |
$ |
(28,894 |
) |
$ |
(20,673 |
) |
|||||
Net loss per share attributable to Cerus Corporation: |
|||||||||||||||||
Basic and diluted |
$ |
(0.07 |
) |
$ |
(0.05 |
) |
$ |
(0.16 |
) |
$ |
(0.12 |
) |
|||||
Weighted average shares outstanding: |
|||||||||||||||||
Basic and diluted |
|
180,611 |
|
|
176,944 |
|
|
179,449 |
|
|
175,718 |
|
|||||
CERUS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) |
||||||
June 30, |
December 31, |
|||||
2023 |
2022 |
|||||
ASSETS |
(unaudited) |
|||||
Current assets: |
||||||
Cash and cash equivalents |
$ |
20,635 |
$ |
35,585 |
||
Short-term investments |
|
63,868 |
|
66,569 |
||
Accounts receivable |
|
22,175 |
|
34,426 |
||
Inventories |
|
40,608 |
|
29,003 |
||
Prepaid and other current assets |
|
3,650 |
|
4,561 |
||
Total current assets |
|
150,936 |
|
170,144 |
||
Non-current assets: |
||||||
Property and equipment, net |
|
10,254 |
|
10,969 |
||
Operating lease right-of-use assets |
|
12,268 |
|
12,512 |
||
Goodwill |
|
1,316 |
|
1,316 |
||
Restricted cash and other assets |
|
24,086 |
|
23,151 |
||
Total assets |
$ |
198,860 |
$ |
218,092 |
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||
Current liabilities: |
||||||
Accounts payable and accrued liabilities |
$ |
54,999 |
$ |
58,205 |
||
Debt – current |
|
16,542 |
|
56,159 |
||
Operating lease liabilities – current |
|
2,176 |
|
2,105 |
||
Deferred product revenue – current |
|
1,361 |
|
589 |
||
Total current liabilities |
|
75,078 |
|
117,058 |
||
Non-current liabilities: |
||||||
Debt – non-current |
|
54,838 |
|
13,644 |
||
Operating lease liabilities – non-current |
|
14,454 |
|
15,329 |
||
Other non-current liabilities |
|
2,800 |
|
3,499 |
||
Total liabilities |
|
147,170 |
|
149,530 |
||
Stockholders’ equity: |
|
50,816 |
|
67,610 |
||
Noncontrolling interest |
|
874 |
|
952 |
||
Total liabilities and stockholders’ equity |
$ |
198,860 |
$ |
218,092 |
CERUS CORPORATION UNAUDITED RECONCILIATION OF NON-GAAP ADJUSTED EBITDA (in thousands) |
||||||||||||||||
|
|
|
|
|
||||||||||||
|
|
Three Months Ended |
|
Six Months Ended |
||||||||||||
|
|
June 30, |
|
June 30, |
||||||||||||
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net loss attributable to Cerus Corporation |
$ |
(13,275 |
) |
$ |
(8,389 |
) |
$ |
(28,894 |
) |
$ |
(20,673 |
) |
||||
Adjustments to net loss attributable to Cerus Corporation: |
||||||||||||||||
Net loss attributable to noncontrolling interest |
|
(56 |
) |
|
(6 |
) |
|
(78 |
) |
|
(6 |
) |
||||
Provision for income taxes |
|
98 |
|
|
78 |
|
|
175 |
|
|
154 |
|
||||
Total non-operating expense, net (i) |
|
1,593 |
|
|
1,482 |
|
|
3,011 |
|
|
3,842 |
|
||||
Loss from operations |
|
(11,640 |
) |
|
(6,835 |
) |
|
(25,786 |
) |
|
(16,683 |
) |
||||
Adjustments to loss from operations: |
||||||||||||||||
Operating depreciation and amortization |
|
1,164 |
|
|
1,017 |
|
|
2,170 |
|
|
2,096 |
|
||||
Government contract revenue (ii) |
|
(8,875 |
) |
|
(6,632 |
) |
|
(16,377 |
) |
|
(12,208 |
) |
||||
Direct expenses attributable to government contracts (iii) |
|
6,633 |
|
|
5,017 |
|
|
11,809 |
|
|
9,275 |
|
||||
Share-based compensation (iv) |
|
5,720 |
|
|
5,007 |
|
|
11,389 |
|
|
11,433 |
|
||||
Costs attributable to noncontrolling interest (v) |
|
|
130 |
|
|
|
12 |
|
|
|
173 |
|
|
|
12 |
|
Restructuring(vi) |
|
2,128 |
|
|
— |
|
|
2,128 |
|
|
— |
|
||||
Non-GAAP adjusted EBITDA |
|
$ |
(4,740 |
) |
|
$ |
(2,414 |
) |
|
$ |
(14,494 |
) |
|
$ |
(6,075 |
) |
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 reflect 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/20230802522450/en/
Jessica Hanover – Vice President, Corporate Affairs
Cerus Corporation
925-288-6137
Source: Cerus Corporation