-
Q3 product revenue of $10.5 million; reiterating $41-43 million annual
revenue guidance for 2013.
-
INTERCEPT platelet PMA initiated - first of three modules submitted in
September.
-
Third of four modules for INTERCEPT plasma PMA submitted in August.
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced financial results for
the third quarter and nine months ended September 30, 2013.
"This past quarter, we continued to submit INTERCEPT plasma and platelet
PMA modules on schedule, and look forward to completing these
submissions in November 2013 and March 2014, respectively," said William
‘Obi‘ Greenman, Cerus‘ president and chief executive officer. "Our $10.5
million in Q3 product revenue provides steady progress toward our
projected full year revenue guidance of $41-$43 million."
Revenue
Product revenue for the third quarter of 2013 was $10.5 million, a 28%
increase over the third quarter of 2012. Increased deployment of
illuminators in several geographies, as well as elevated sales of plasma
disposable kits and to a lesser extent, a stronger Euro compared to the
U.S. dollar, drove third quarter revenue growth.
Product revenue for the first nine months of 2013 was $30.4 million, and
represented a 16% increase from the same period in 2012. The increase in
product revenue during the first nine months of 2013 over 2012 was
driven primarily by increased demand for our INTERCEPT products,
particularly plasma disposable kits and to a lesser extent, a stronger
Euro compared to the U.S. dollar.
Gross Margins
Gross margins on product sales for the third quarter of 2013 were 35%,
compared to 47% for the third quarter of 2012. Gross margins during the
third quarter of 2013 were negatively impacted by certain period charges
and the mix of products sold relative to the prior year. Gross margins
were 42% for the first nine months of 2013, compared to 41% for the same
period in 2012.
Operating Expenses
Total operating expenses for the third quarter of 2013 were $12.1
million, compared to $8.2 million for the third quarter of 2012; and
$33.3 million for the nine months ended September 30, 2013 compared to
$24.5 million for the same period in the prior year. The year-over-year
increase in operating expenses for both the three and nine months ended
September 30, was due primarily to regulatory activities for the
preparation and submission activities supporting the Company’s PMA
submissions for INTERCEPT plasma and platelets, costs for the clinical
activities regarding the Company’s red blood cell program and increases
in selling, general and administrative expenses in support of the
existing European commercial business and preparatory market research
activities for a potential U.S. launch of the INTERCEPT Blood System for
plasma and platelets. The company expects these activities to continue
to drive increasing operating expenses.
Operating and Net Loss
Operating losses during the third quarter of 2013 were $8.4 million,
compared to $4.3 million during the third quarter of 2012, and $20.5
million compared to $13.7 million for the nine months ended September
30, 2013 and 2012, respectively. Despite the increased product revenues
reported during both the three and nine months ended September 30, 2013
compared to 2012, operating losses widened due to the increased
investments made in support of our PMA submission activities and our
clinical activities with respect to our red blood cell program during
the same periods.
Net loss for the third quarter of 2013 was $20.5 million, or $0.29 per
share, compared to a net loss of $3.5 million, or $0.08 per diluted
share, for the third quarter of 2012. Net loss for the first nine months
of 2013 was $37.5 million, or $0.56 per share, compared to a net loss of
$14.2 million, or $0.26 per share, for the same period of 2012. Net
losses were impacted by the mark-to-market adjustments of the Company's
outstanding warrants to fair value. These adjustments resulted in
non-cash charges of $12.4 million during the third quarter of 2013
compared to a gain of $0.9 million during the third quarter of 2012 and
non-cash charges of $16.8 million compared to non-cash gains of $0.1
million during the nine months ended September 30, 2013 and 2012,
respectively.
Cash and Cash Equivalents
At September 30, 2013, the Company had cash and cash equivalents and
short-term investments of $53.3 million compared to $26.7 million at
December 31, 2012 and $58.2 million at June 30, 2013. The Company‘s $7.0
million revolving line of credit remains outstanding with approximately
$3.4 million available for future borrowing.
Recent Highlights
-
INTERCEPT platelet PMA initiated with submission of first module in
September 2013; remaining module submissions scheduled for December
2013 and March 2014.
-
Third of four modules of INTERCEPT plasma PMA submitted in August
2013; submission of final module planned for November 2013.
-
Daniel Swisher appointed Chair of Cerus Board of Directors to replace
BJ Cassin, who will retire at year end.
QUARTERLY CONFERENCE CALL
The Company will host a conference call and webcast at 4:15 p.m. Eastern
time today to discuss its financial results and provide a general
business overview and outlook. To access the live webcast, please visit
the Investor Relations page of the Cerus website at http://www.cerus.com/ir.
Alternatively, you may access the live conference call by dialing
866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the company’s web site, or by dialing
855-859-2056 (U.S.) or 404-537-3406 (international) and entering
conference ID number 31979526. The replay will be available
approximately three hours after the call through November 11, 2013.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood safety. The company’s INTERCEPT Blood System has been
demonstrated to inactivate a broad range of viruses, bacteria and
parasites that may be present in donated blood, including established
threats such as hepatitis B and C, HIV, West Nile virus and bacteria, as
well as emerging pathogens such as influenza, malaria and dengue. Cerus
currently markets and sells the INTERCEPT Blood System for both
platelets and plasma in Europe, the Commonwealth of Independent States,
the Middle East and selected countries in other regions around the
world. In the United States, Cerus is seeking regulatory approval of the
INTERCEPT Blood System for plasma and platelets. The INTERCEPT red blood
cell system is in clinical development. See http://www.cerus.com
for more information.
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 results, including statements concerning Cerus’
expectations regarding future sales growth and its 2013 revenues, the
anticipated timing, completion and success of modular PMA submissions to
the FDA for the INTERCEPT Blood System for plasma and platelets, the
potential U.S. commercial launch of the INTERCEPT Blood System for
plasma and platelets, future operating expenses, research and
development activity and the expenses related thereto, marketing
activity and expenses in support of Cerus’ planned commercialization
activities, and the continued availability of Cerus‘ revolving line of
credit. Actual results could differ materially from these
forward-looking statements as a result of certain factors, including,
without limitation, risks associated with the commercialization and
market acceptance of, and customer demand for, the INTERCEPT Blood
System, the uncertain and time-consuming regulatory process, Cerus'
ability to successfully conduct its ongoing clinical trials for the red
blood cell system in the anticipated timeframes, or at all, the fact
that Cerus may encounter unanticipated difficulties complying with the
prescribed submission timing or other modular PMA requirements related
to the INTERCEPT Blood System for plasma and/or platelets, the fact that
Cerus may be required to conduct additional clinical development in
support of its modular PMA submissions for plasma and/or platelets, and
that if additional clinical development is required it may require
funding that Cerus does not have and could significantly delay or
preclude regulatory approval of the INTERCEPT Blood System for plasma
and platelets in the United States, adverse market and economic
conditions, adverse fluctuations in foreign exchange rates, Cerus’
reliance on third parties to market, sell, distribute and maintain its
products, Cerus‘ lack of commercialization experience in the United
States and its ability to establish, or contract with third parties to
establish, sales, marketing and other sufficient capabilities to
potentially market and sell the INTERCEPT Blood System for plasma and
platelets in the United States, Cerus‘ ability to comply with applicable
regulatory guidelines and requirements with respect to the marketing and
manufacturing of products in the United States, Cerus’ ability to
maintain an effective manufacturing supply chain, Cerus‘ ability to
continue to comply with the financial and other covenants under its
revolving line of credit, as well as other risks detailed in Cerus’
filings with the Securities and Exchange Commission, including Cerus’
Quarterly Report on Form 10-Q for the quarterly period ended June 30,
2013 filed with the SEC on August 2, 2013. Cerus disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
|
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands except per share information)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
2013
|
|
|
|
|
2012
|
|
|
|
|
|
2013
|
|
|
|
|
2012
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
$
|
10,542
|
|
|
|
$
|
8,252
|
|
|
|
|
$
|
30,425
|
|
|
|
$
|
26,258
|
|
|
Cost of revenue
|
|
|
|
|
6,826
|
|
|
|
|
4,411
|
|
|
|
|
|
17,663
|
|
|
|
|
15,499
|
|
|
Gross profit
|
|
|
|
|
3,716
|
|
|
|
|
3,841
|
|
|
|
|
|
12,762
|
|
|
|
|
10,759
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
4,363
|
|
|
|
|
1,903
|
|
|
|
|
|
10,569
|
|
|
|
|
5,439
|
|
|
Selling, general and administrative
|
|
|
|
|
7,728
|
|
|
|
|
6,219
|
|
|
|
|
|
22,535
|
|
|
|
|
18,871
|
|
|
Amortization of intangible assets
|
|
|
|
|
50
|
|
|
|
|
50
|
|
|
|
|
|
151
|
|
|
|
|
151
|
|
|
Total operating expenses
|
|
|
|
|
12,141
|
|
|
|
|
8,172
|
|
|
|
|
|
33,255
|
|
|
|
|
24,461
|
|
|
Loss from operations
|
|
|
|
|
(8,425
|
)
|
|
|
|
(4,331
|
)
|
|
|
|
|
(20,493
|
)
|
|
|
|
(13,702
|
)
|
|
Non-operating income (expense), net
|
|
|
|
|
(12,016
|
)
|
|
|
|
926
|
|
|
|
|
|
(16,819
|
)
|
|
|
|
(368
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations before income taxes
|
|
|
|
|
(20,441
|
)
|
|
|
|
(3,405
|
)
|
|
|
|
|
(37,312
|
)
|
|
|
|
(14,070
|
)
|
|
Provision for income taxes
|
|
|
|
|
60
|
|
|
|
|
55
|
|
|
|
|
|
165
|
|
|
|
|
131
|
|
|
Net loss
|
|
|
|
$
|
(20,501
|
)
|
|
|
$
|
(3,460
|
)
|
|
|
|
$
|
(37,477
|
)
|
|
|
$
|
(14,201
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
$
|
(0.29
|
)
|
|
|
$
|
(0.06
|
)
|
|
|
|
$
|
(0.56
|
)
|
|
|
$
|
(0.26
|
)
|
|
Diluted
|
|
|
|
$
|
(0.29
|
)
|
|
|
$
|
(0.08
|
)
|
|
|
|
$
|
(0.56
|
)
|
|
|
$
|
(0.26
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used for computing net
loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
|
69,791
|
|
|
|
|
54,875
|
|
|
|
|
|
66,464
|
|
|
|
|
54,130
|
|
|
Diluted
|
|
|
|
|
69,791
|
|
|
|
|
55,377
|
|
|
|
|
|
66,464
|
|
|
|
|
54,130
|
|
|
|
|
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2013
|
|
|
December 31,
2012
|
|
|
|
|
|
|
|
|
|
|
Cash & cash equivalents
|
|
|
|
$
|
24,355
|
|
|
$
|
26,696
|
|
Investments
|
|
|
|
|
28,971
|
|
|
|
--
|
|
Accounts receivable and other current assets
|
|
|
|
|
8,490
|
|
|
|
7,120
|
|
Inventories
|
|
|
|
|
12,686
|
|
|
|
10,180
|
|
Property and equipment, net
|
|
|
|
|
1,848
|
|
|
|
1,698
|
|
Goodwill and intangible assets
|
|
|
|
|
2,711
|
|
|
|
2,862
|
|
Other assets
|
|
|
|
|
378
|
|
|
|
363
|
|
Total assets
|
|
|
|
$
|
79,439
|
|
|
$
|
48,919
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
|
$
|
16,136
|
|
|
$
|
14,805
|
|
Deferred revenue
|
|
|
|
|
111
|
|
|
|
77
|
|
Debt - current
|
|
|
|
|
3,638
|
|
|
|
4,828
|
|
Warrant liability
|
|
|
|
|
22,706
|
|
|
|
5,903
|
|
Debt - non-current
|
|
|
|
|
--
|
|
|
|
2,896
|
|
Other non-current liabilities
|
|
|
|
|
1,202
|
|
|
|
1,303
|
|
Total liabilities
|
|
|
|
|
43,793
|
|
|
|
29,812
|
|
Stockholders’ equity
|
|
|
|
|
35,646
|
|
|
|
19,107
|
|
Total liabilities and stockholders’ equity
|
|
|
|
$
|
79,439
|
|
|
$
|
48,919
|
Source: Cerus Corporation