-
Year-over-year INTERCEPT revenue growth of 12%;
-
U.S. FDA acceptance of proposed modular Premarket Approval (PMA)
application shell for review of INTERCEPT platelets; last module
expected to be submitted by March 2014;
-
$40.25 million in gross proceeds raised from public offering of common
stock
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced financial results for
the first quarter ended March 31, 2013.
"We ended the first quarter of 2013 with a stronger balance sheet and a
clear focus on successfully submitting the INTERCEPT platelet and plasma
modular PMA applications in the U.S.," said William 'Obi' Greenman,
president and chief executive officer of Cerus Corporation. "With regard
to our ongoing sales growth in our current commercial markets, we are on
plan to reach our guidance of $41-$43 million in product revenue for the
year."
Revenue
Product revenue for the first quarter of 2013 was $9.7 million, a 12%
increase over the first quarter of 2012. Continued growth in certain
markets and continued placement of INTERCEPT illumination devices drove
the revenue growth.
The Company did not recognize any government grant revenue during the
first quarter of 2013, as government grants in support of the Company’s
red blood cell system had been fully utilized by January 2012. During
the first quarter of 2012, the Company recognized $0.1 million of
government grant revenue.
Gross Margins
Gross margins on product sales for the first quarter of 2013 were 48%,
compared to 37% for the first quarter of 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 during the second half of 2012.
Operating Expenses
Total operating expenses for the first quarter of 2013 were $9.6
million, compared to $7.8 million for the first quarter of 2012. The
increase in these operating expenses was due to regulatory activities
for the preparation and submission of the first module for the Company’s
PMA application for INTERCEPT plasma and the preparation and submission
of a proposal for a modular PMA application for INTERCEPT platelets,
costs for the preparation of planned Phase III clinical trials related
to the Company’s red blood cell program in Europe and increases in
selling, general and administrative expenses in support of growing the
commercial business in Europe, the Middle East, and The Commonwealth of
Independent States.
Operating expenses are expected to continue to increase in 2013, largely
driven by increased research and development expenses. The Company
expects to incur increased development and regulatory costs in 2013 in
support of the modular PMA submissions to the FDA for the licensure of
the INTERCEPT platelet and plasma systems. In addition, the Company
expects to incur costs related to preparatory marketing activities in
anticipation of the potential future U.S. launch of both products. The
planned clinical trials and in vitro studies to support potential
regulatory approval of the INTERCEPT red blood cell system will also
contribute to the expected increase in operating expenses.
Operating and Net Loss
Operating losses during the first quarter of 2013 were $5.0 million,
compared to $4.6 million during the first quarter of 2012. The increase
in operating losses was driven by higher operating expenses incurred
during the first quarter of 2013 compared to the first quarter of 2012,
partially offset by increased product revenue and improved gross margins
on product sales during the first quarter of 2013.
Net loss for the first quarter of 2013 was $10.3 million, or $0.17 per
share, compared to a net loss of $8.8 million, or $0.17 per share, for
the first quarter of 2012. Net losses were impacted by the
mark-to-market adjustments of the Company's outstanding warrants to fair
value, which resulted in non-cash charges of $5.1 million during the
first quarter of 2013 compared to $4.5 million during the first quarter
of 2012.
Cash and Cash Equivalents
At March 31, 2013, the Company had cash and cash equivalents of $69.2
million. 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 $4.0 million available for future
borrowing.
Recent Highlights
-
FDA accepts the INTERCEPT platelet PMA application shell structure and
timing
-
Swissmedic and Swiss Red Cross present national haemovigilance data
showing favourable safety profile for INTERCEPT-treated platelet
components
-
Cerus signs INTERCEPT platelet agreements with two key blood component
suppliers in Germany and Austria
-
Cerus closes public offering of common stock, raising $40.25 million
in gross proceeds.
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 96997633. The replay will be available
approximately three hours after the call through May 13, 2013.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on
commercializing the INTERCEPT Blood System to enhance blood safety. The
INTERCEPT system is designed to reduce the risk of
transfusion-transmitted diseases by inactivating a broad range of
pathogens such as viruses, bacteria and parasites that may be present in
donated blood. The nucleic acid targeting mechanism of action enables
INTERCEPT treatment to inactivate established transfusion threats, such
as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed
to inactivate 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 Blood
System for red blood cells 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,
including additional clinical development, in support of Cerus’
regulatory submissions and the expenses related thereto, marketing
activity and expenses in support of Cerus’ planned commercialization
activities, and the future development and potential regulatory approval
of the INTERCEPT Blood System for red blood cells and the expenses
related thereto. 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 clinical development and
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 will require funding that
Cerus does not currently have and will significantly delay and could
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, intellectual property protection, as well as other risks detailed
in Cerus’ filings with the Securities and Exchange Commission, including
Cerus’ Annual Report on Form 10-K for the year ended December 31, 2012
filed with the SEC on March 12, 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
March 31,
|
|
|
|
2013
|
|
2012
|
|
Product Related:
|
|
|
|
|
|
Product revenue
|
|
$
|
9,733
|
|
|
$
|
8,691
|
|
|
Cost of product revenue
|
|
|
5,090
|
|
|
|
5,514
|
|
|
Gross profit on product revenue
|
|
|
4,643
|
|
|
|
3,177
|
|
|
|
|
|
|
|
|
Government grant and cooperative agreements revenue
|
|
|
--
|
|
|
|
91
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
Research and development
|
|
|
2,700
|
|
|
|
1,824
|
|
|
Selling, general and administrative
|
|
|
6,853
|
|
|
|
5,966
|
|
|
Amortization of intangible assets
|
|
|
50
|
|
|
|
50
|
|
|
Total operating expenses
|
|
|
9,603
|
|
|
|
7,840
|
|
|
Loss from operations
|
|
|
(4,960
|
)
|
|
|
(4,572
|
)
|
|
Non-operating income (expense), net
|
|
|
(5,241
|
)
|
|
|
(4,227
|
)
|
|
|
|
|
|
|
|
Loss from operations before income taxes
|
|
|
(10,201
|
)
|
|
|
(8,799
|
)
|
|
Provision for income taxes
|
|
|
51
|
|
|
|
35
|
|
|
Net loss
|
|
$
|
(10,252
|
)
|
|
$
|
(8,834
|
)
|
|
|
|
|
|
|
|
Net loss per common share:
|
|
|
|
|
|
Basic and Diluted
|
|
$
|
(0.17
|
)
|
|
$
|
(0.17
|
)
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used for computing net
loss per common share:
|
|
|
|
|
|
Basic and Diluted
|
|
|
59,730
|
|
|
|
53,088
|
|
|
CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
March 31,
2013
|
|
December 31,
2012
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
69,163
|
|
$
|
26,696
|
|
Accounts receivable and other current assets
|
|
|
6,521
|
|
|
7,120
|
|
Inventories
|
|
|
11,756
|
|
|
10,180
|
|
Property and equipment, net
|
|
|
1,595
|
|
|
1,698
|
|
Goodwill and intangible assets
|
|
|
2,812
|
|
|
2,862
|
|
Other assets
|
|
|
360
|
|
|
363
|
|
Total assets
|
|
$
|
92,207
|
|
$
|
48,919
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
12,036
|
|
$
|
14,805
|
|
Deferred revenue
|
|
|
174
|
|
|
77
|
|
Debt - current
|
|
|
4,470
|
|
|
4,828
|
|
Warrant liability
|
|
|
10,976
|
|
|
5,903
|
|
Debt - non-current
|
|
|
2,485
|
|
|
2,896
|
|
Other non-current liabilities
|
|
|
1,278
|
|
|
1,303
|
|
Total liabilities
|
|
|
31,419
|
|
|
29,812
|
|
Stockholders’ equity
|
|
|
60,788
|
|
|
19,107
|
|
Total liabilities and stockholders’ equity
|
|
$
|
92,207
|
|
$
|
48,919
|
Source: Cerus Corporation