CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced financial results for
the second quarter ended June 30, 2012.
Second quarter 2012 results:
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Revenue of $9.2 million, a 37% increase from the second quarter of
2011;
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Operating expenses of $8.4 million compared to $8.3 million incurred
during the second quarter of 2011; and
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Cash of $26.7 million at June 30, 2012 compared to $31.5 million at
March 31, 2012 and $25.8 million at December 31, 2011.
First half 2012 results:
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Total revenue of $18.0 million, a 35% increase from the first half of
2011;
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Product revenue of $17.9 million, a 38% increase from the first half
of 2011; and
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Operating expenses of $16.3 million compared to $15.6 million incurred
during the first half of 2011.
“Cerus continued to deliver strong growth during the second quarter,
with increased demand for INTERCEPT disposable kits,” said William ‘Obi’
Greenman, president and chief executive officer of Cerus Corporation.
“We reiterate our 2012 guidance for revenue of $34 million to $36
million. We continue to make encouraging progress within our red blood
cell program and we expect to initiate our Phase III acute anemia trial
in Europe in the third quarter, the first of two European Phase III
studies planned to start this year.”
Revenue
Revenue for the second quarter of 2012 was $9.2 million, derived
entirely from product sales. These revenues represent a 37% increase
from the $6.8 million recognized during second quarter of 2011. The
increase in revenue was driven primarily by a 37% increase in
year-over-year demand for INTERCEPT disposable kits.
Total revenue for the first half of 2012 was $18.0 million, up from the
$13.4 million recognized during the first half of 2011. Product revenue
for the first half of 2012 was $17.9 million, and represented a 38%
increase from the first half of 2011. The increase in product revenue
during the first half of 2012 over 2011 was driven primarily by a 46%
increase in demand for INTERCEPT disposable kits.
Government grant revenue for the first half of 2012 was $0.1 million,
down from $0.4 million recognized during the first half of 2011. The
availability of government grants awarded to Cerus in support of the
Company’s red blood cell system has been fully exhausted. The Company
does not currently expect any incremental government grant revenue
during the second half of 2012.
Gross Margins
Gross margins for the second quarter of 2012 were 40%, equivalent to
gross margins reported for the second quarter of 2011. Gross margins for
the first half of 2012 were 38%, compared to 43% for same period in
2011. Gross margins during the first half of 2012 were affected by the
mix of products sold and, during the first quarter of 2012, were
negatively impacted by accounting charges associated with high scrap
rates for certain components used to make INTERCEPT disposable kits.
Operating Expenses
Total operating expenses for the second quarter of 2012 were $8.4
million, compared to $8.3 million for the second quarter of 2011. Total
operating expenses for the first half of 2012 were $16.3 million,
compared to $15.6 million for the first half of 2011. The increase in
operating expenses was related to increases in selling, general and
administrative expenses in support of the growing commercial business in
Europe, the Middle East, The Commonwealth of Independent States and the
expansion into new markets and geographies. Operating expenses are
expected to increase during the second half of 2012 and into 2013,
driven by increased research and development expenses associated with
the planned clinical trials and in-vitro studies to support potential
regulatory approval of the INTERCEPT red blood cell system.
Operating and Net Loss
Operating losses during the second quarter of 2012 were improved from
those incurred during the same period in 2011. The improvement in
operating losses was attributable to the growth in revenue, stable gross
margins, and relatively consistent operating expenses during the two
comparative periods. Operating losses for the first half of 2012 were
also improved from operating losses incurred during the first half of
2011, primarily due to the increase in product revenue.
Net loss for the second quarter of 2012 was $1.9 million, or $0.10 per
diluted share, compared to a net loss of $6.4 million, or $0.13 per
diluted share, for the second quarter of 2011. The change in net loss
was primarily affected by a second quarter 2012 non-cash gain of $3.7
million compared to a similar charge of $0.3 million for the same period
in 2011, resulting from the mark-to-market adjustments of Cerus’
outstanding warrants. Net loss for the first half of 2012 was $10.7
million, or $0.20 per diluted share, compared to a net loss of $11.5
million, or $0.24 per diluted share, for the first half of 2011.
Cash and Investments
At June 30, 2012, the Company had cash, cash equivalents and short-term
investments of $26.7 million, up from $25.8 million at December 31,
2011. Cash payments to vendors for the increase in inventory during the
first half of 2012 were a significant contributing factor in the amount
of net cash used during the quarter.
OTHER RECENT PROGRESS:
-
Preliminary regulatory reviews of the clinical trial applications for
the planned INTERCEPT red cell Phase III acute anemia have been
completed in France and Germany; enrollment is anticipated to begin in
the third quarter.
-
Preparations continue for future expected initiation of the planned
Phase III red cell chronic anemia trial in Italy, and the planned U.S.
Phase II red cell study.
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. To access the live webcast, please visit the Investor
Relations page of the Cerus web site at http://www.cerus.com/Investors/Investor-Overview.
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 63119152. The replay will be available
approximately three hours after the call through August 16, 2012.
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. 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 its 2012 revenues, future operating expenses and
cash used to support operations, statements relating to potential
regulatory approvals and other future regulatory matters, and statements
relating to planned preparation, initiation and enrollment of clinical
trials and the future development of the INTERCEPT Blood System for red
blood cells. 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, including the risks that Cerus may be unable to
initiate planned clinical trials for the INTERCEPT Blood System for red
blood cells in the timeframe expressed herein or otherwise in a timely
manner, or at all, 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’ Quarterly Report on
Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May
7, 2012. Cerus disclaims any obligation or undertaking to update or
revise any forward-looking statements contained in this press release.
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CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS
(in thousands except per share information)
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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2012
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2011
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2012
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2011
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Revenue:
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Product revenue
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$
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9,224
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|
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$
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6,753
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$
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17,915
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$
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12,936
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Government grant and cooperative agreements
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--
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--
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91
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|
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436
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Total revenue
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9,224
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6,753
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18,006
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13,372
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Cost of product revenue
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5,574
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4,074
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11,088
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7,603
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Gross profit
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3,650
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2,679
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6,918
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5,769
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Operating expenses:
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Research and development
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1,712
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1,994
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3,536
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3,802
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Selling, general and administrative
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6,686
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6,207
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12,652
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11,735
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Amortization of intangible assets
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51
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51
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101
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101
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Total operating expenses
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8,449
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8,252
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16,289
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15,638
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Loss from operations
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(4,799
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)
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(5,573
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)
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(9,371
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)
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(9,869
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)
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Non-operating income (expense), net
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2,892
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(836
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)
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(1,370
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)
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(1,638
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)
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Net loss
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$
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(1,907
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)
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$
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(6,409
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)
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$
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(10,741
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)
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$
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(11,507
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)
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Net loss per common share:
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Basic
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$
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(0.04
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)
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$
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(0.13
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)
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$
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(0.20
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)
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$
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(0.24
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)
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Diluted
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$
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(0.10
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)
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$
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(0.13
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)
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$
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(0.20
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)
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$
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(0.24
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)
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Weighted average common shares outstanding used for computing net
loss per common share:
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Basic
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54,418
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47,620
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53,753
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47,530
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Diluted
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55,236
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47,620
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53,753
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47,530
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CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
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June 30,
2012
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December 31,
2011
|
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Cash, cash equivalents, and short-term investments
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$
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26,667
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$
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25,784
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Accounts receivable and other current assets
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4,749
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|
7,511
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Inventories
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9,373
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6,444
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Property and equipment, net
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1,866
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|
2,032
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Goodwill and intangible assets
|
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|
2,963
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|
3,064
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Other assets
|
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|
445
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|
|
532
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Total assets
|
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$
|
46,063
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$
|
45,367
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Accounts payable and accrued liabilities
|
|
$
|
10,083
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$
|
10,505
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Deferred revenue
|
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|
136
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|
|
111
|
|
Debt - current
|
|
|
3,692
|
|
|
2,519
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Warrant liability
|
|
|
8,749
|
|
|
7,979
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Debt - non-current
|
|
|
3,717
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|
|
4,697
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Other non-current liabilities
|
|
|
1,167
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|
|
1,243
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Total liabilities
|
|
|
27,544
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|
|
27,054
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Stockholders’ equity
|
|
|
18,519
|
|
|
18,313
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Total liabilities and stockholders’ equity
|
|
$
|
46,063
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|
$
|
45,367
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Source: Cerus Corporation