-
Q2 product revenue of $10.2 million; reiterating $41-43 million annual
revenue guidance for 2013.
-
European Phase III red blood cell studies initiated in both acute and
chronic anemia.
-
Second module of INTERCEPT plasma PMA submitted on schedule in May.
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced financial results for
the second quarter ended June 30, 2013.
"Successful completion of the INTERCEPT platelet and plasma U.S. PMA
submissions in November 2013 and March 2014, respectively, remains a top
Cerus priority, and our team continues to deliver on these goals
alongside the recent initiation of Phase III European studies for
INTERCEPT red cells,“ said William ‘Obi‘ Greenman, Cerus‘ president and
chief executive officer. “In Q2, we also achieved $10.2 million in
product revenue, providing steady progress toward our projected full
year revenue guidance of $41-$43 million.“
Revenue
Product revenue for the second quarter of 2013 was $10.2 million, a 10%
increase over the second quarter of 2012. Continued growth in certain
markets for both INTERCEPT illuminators and disposable kits drove a
significant portion of the revenue growth.
Product revenue for the first half of 2013 was $19.9 million, and
represented an 11% increase from the first half of 2012. The increase in
product revenue during the first half of 2013 over 2012 was driven
primarily by increased demand for our INTERCEPT products.
There was no government grant revenue recognized in the second quarter
and first half of 2013, as compared to $0.1 million recognized during
the first half of 2012.
Gross Margins
Gross margins on product sales for the second quarter of 2013 were 43%,
compared to 40% for the second quarter of 2012. Gross margins were 45%
for the first six months of 2013, compared to 38% for the same period in
2012. The improvement in gross margins on product sales was driven
primarily by lower costs for products sold as a result of improved
overhead absorption due to higher manufacturing levels.
Operating Expenses
Total operating expenses for the second quarter of 2013 were $11.5
million, compared to $8.4 million for the second quarter of 2012, and
$21.1 million compared to $16.3 million for the six months ended June
30, 2013 and 2012, respectively. The increase in operating expenses 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 in preparatory market research activities for a
potential U.S. launch.
Operating expenses are expected to continue to increase in 2013, largely
driven by increased research and development expenses. The Company
expects to continue to incur increased development and regulatory costs
in the second half of 2013 in continued support of the modular PMA
submissions to the FDA for the licensure of the INTERCEPT platelet and
plasma systems and clinical activities related to the INTERCEPT red
blood cell system, as well as additional selling, general and
administrative expenses related to the potential future U.S. launch of
both products.
Operating and Net Loss
Operating losses during the second quarter of 2013 were $7.1 million,
compared to $4.8 million during the second quarter of 2012, and $12.1
million compared to $9.4 million for the six months ended June 30, 2013
and 2012, respectively. The increase in operating losses was driven by
higher operating expenses incurred in connection with our PMA submission
activities and our clinical activities with respect to our red blood
cell program during the three and six months ended June 30, 2013
compared to the same periods of 2012, partially offset by increased
product revenue and improved gross margins on product sales during both
the three and six months ended June 30, 2013 compared to the same
periods of 2012.
Net loss for the second quarter of 2013 was $6.7 million, or $0.10 per
share, compared to a net loss of $1.9 million, or $0.04 per share, for
the second quarter of 2012. Net loss for the first half of 2013 was
$17.0 million, or $0.26 per share, compared to a net loss of $10.7
million, or $0.20 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 gains of $0.7 million during the second quarter of 2013
compared to $3.7 million during the second quarter of 2012 and non-cash
losses of $4.4 million and $0.8 million during the six months ended June
30, 2013 and 2012, respectively.
Cash and Cash Equivalents
At June 30, 2013, the Company had cash and cash equivalents of $58.2
million compared to $26.7 million at December 31, 2012 and $69.2 million
from March 31, 2013. In April 2013, the Company repaid its outstanding
$4.2 million of term debt. The Company‘s $7.0 million revolving line of
credit remains outstanding with approximately $4.8 million available for
future borrowing.
Recent Highlights
-
FDA accepts proposed INTERCEPT platelet PMA application shell
structure and timing; first module planned for September 2013
submission
-
Second module of INTERCEPT plasma PMA submitted in May; remaining
modules planned for August and November 2013
-
Patient enrollment initiated in European Phase III clinical trials for
INTERCEPT Red Blood Cells in acute and chronic anemia indications
-
First Danish hospital signs INTERCEPT agreement to treat platelets
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 31978377. The replay will be available
approximately three hours after the call through August 12, 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
timing 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, and marketing activity and expenses in
support of Cerus’ planned commercialization activities. 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
initiate and conduct planned clinical trials 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, 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’ ability to maintain an effective manufacturing supply
chain, 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 three months ended March 31, 2013 filed with the SEC
on May 3, 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
|
2013
|
|
|
|
2012
|
|
|
|
2013
|
|
|
|
2012
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product revenue
|
|
$
|
10,150
|
|
|
$
|
9,224
|
|
|
$
|
19,883
|
|
|
$
|
17,915
|
|
|
Cost of product revenue
|
|
|
5,747
|
|
|
|
5,574
|
|
|
|
10,837
|
|
|
|
11,088
|
|
|
Gross profit on product revenue
|
|
|
4,403
|
|
|
|
3,650
|
|
|
|
9,046
|
|
|
|
6,827
|
|
|
|
|
|
|
|
|
|
|
|
|
Government grant and cooperative agreements revenue
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
91
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,506
|
|
|
|
1,712
|
|
|
|
6,206
|
|
|
|
3,536
|
|
|
Selling, general and administrative
|
|
|
7,954
|
|
|
|
6,686
|
|
|
|
14,807
|
|
|
|
12,652
|
|
|
Amortization of intangible assets
|
|
|
51
|
|
|
|
51
|
|
|
|
101
|
|
|
|
101
|
|
|
Total operating expenses
|
|
|
11,511
|
|
|
|
8,449
|
|
|
|
21,114
|
|
|
|
16,289
|
|
|
Loss from operations
|
|
|
(7,108
|
)
|
|
|
(4,799
|
)
|
|
|
(12,068
|
)
|
|
|
(9,371
|
)
|
|
Non-operating income (expense), net
|
|
|
438
|
|
|
|
2,933
|
|
|
|
(4,803
|
)
|
|
|
(1,294
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations before income taxes
|
|
|
(6,670
|
)
|
|
|
(1,866
|
)
|
|
|
(16,871
|
)
|
|
|
(10,665
|
)
|
|
Provision for income taxes
|
|
|
54
|
|
|
|
41
|
|
|
|
105
|
|
|
|
76
|
|
|
Net loss
|
|
$
|
(6,724
|
)
|
|
$
|
(1,907
|
)
|
|
$
|
(16,976
|
)
|
|
$
|
(10,741
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.10
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.20
|
)
|
|
Diluted
|
|
$
|
(0.10
|
)
|
|
$
|
(0.10
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.20
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used for computing net
loss per common share:
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
69,727
|
|
|
|
54,418
|
|
|
|
64,756
|
|
|
|
53,753
|
|
|
Diluted
|
|
|
71,928
|
|
|
|
55,236
|
|
|
|
64,756
|
|
|
|
53,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
June 30,
2013
|
|
December 31,
2012
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments
|
|
$
|
58,201
|
|
$
|
26,696
|
|
Accounts receivable and other current assets
|
|
|
6,807
|
|
|
7,120
|
|
Inventories
|
|
|
12,762
|
|
|
10,180
|
|
Property and equipment, net
|
|
|
1,641
|
|
|
1,698
|
|
Goodwill and intangible assets
|
|
|
2,761
|
|
|
2,862
|
|
Other assets
|
|
|
376
|
|
|
363
|
|
Total assets
|
|
$
|
82,548
|
|
$
|
48,919
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
13,783
|
|
$
|
14,805
|
|
Deferred revenue
|
|
|
153
|
|
|
77
|
|
Debt - current
|
|
|
2,157
|
|
|
4,828
|
|
Warrant liability
|
|
|
10,290
|
|
|
5,903
|
|
Debt - non-current
|
|
|
--
|
|
|
2,896
|
|
Other non-current liabilities
|
|
|
1,220
|
|
|
1,303
|
|
Total liabilities
|
|
|
27,603
|
|
|
29,812
|
|
Stockholders’ equity
|
|
|
54,945
|
|
|
19,107
|
|
Total liabilities and stockholders’ equity
|
|
$
|
82,548
|
|
$
|
48,919
|
Source: Cerus Corporation