CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) today announced financial results for
the fourth quarter and year ended December 31, 2015.
Recent company highlights include:
U.S. Progress –
-
Signed INTERCEPT™ platelet and plasma supply agreements with the
American Red Cross, Roswell Park Cancer Institute, Blood Systems,
Inc., OneBlood, Inc., LifeShare Blood Centers, ARUP, Inc., Rhode
Island Blood Center, Shepeard Community Blood Center, Mississippi
Valley Regional Blood Center, Community Blood Center
-
Received CMS permanent P-codes for outpatient hospital billing of
pathogen-reduced platelets and plasma
-
AABB authorized use of the INTERCEPT Blood System for platelets to
reduce the risk of transfusion-associated graft versus host disease
-
Began enrollment in the Phase IV PIPER Study, which Cerus is
conducting as its FDA-required post-approval haemovigilance study
-
Announced a collaboration agreement with Haemonetics for the use of
Acrodose™ platelet kits with the INTERCEPT Blood System for platelets
International Progress –
-
Regulatory approval obtained for use of the INTERCEPT Blood System for
platelets and plasma in Brazil, Peru, and Colombia
-
Appointed new leadership for the Europe, Middle East and Africa region
-
Signed INTERCEPT platelet and plasma supply agreement with the
National Transfusiology Center of Mongolia
Recognition of pathogen reduction as a Zika
intervention –
-
The U.S. Food and Drug Administration’s (FDA) guidance document
regarding Zika allows for the use of pathogen reduction to reduce
transfusion risk and maintain local blood availability
-
The World Health Organization (WHO) guidelines for maintaining a safe
and adequate blood supply during Zika virus outbreaks includes
pathogen reduction technology for safeguarding platelet and plasma
supplies in areas with active transmission
“The current Zika outbreak highlights the need for a proactive solution
to secure the safety and availability of national blood supplies. The
FDA and WHO have now recognized that pathogen reduction is an integral
component to ensure that patients are protected from possible
transfusion transmission of Zika, as well as dengue and chikungunya
viruses,” said William 'Obi' Greenman, Cerus’ president and chief
executive officer. “Looking ahead, with over 60% of the U.S. market now
under contract and a long term agreement with the American Red Cross, we
expect to begin to transition these contracts into revenue in 2016, and
in Europe, we seek to initiate our launch planning for our INTERCEPT red
cell system pursuant to our planned CE Mark submission in the second
half of the year.”
Revenue
Product revenue for the fourth quarter of 2015 was $9.7 million compared
to revenue for the same period in 2014 of $9.6 million. This reflects a
22% year over year increase in INTERCEPT disposable kit demand. Revenue
for the year ended December 31, 2015 was $34.2 million, compared to
$36.4 million for the year ended December 31, 2014. INTERCEPT disposable
kit demand over the full year time period grew by 15%, in line with our
expectations.
Looking ahead, the Company expects 2016 global revenue in the range of
$37 million to $40 million.
Gross Margins
Gross margins for the fourth quarter of 2015 were 36%, compared to 31%
for the fourth quarter of 2014. Gross margins for the year ended
December 31, 2015, were 31%, compared with 42% in the same period in
2014.
The Company recorded period charges for expiring inventory and certain
minimum contractual purchase commitments which negatively impacted
margins by approximately 10% and 7% for the quarter and year ended
December 31, 2015, respectively. These types of charges impacted margins
by less than 1% during the same periods of 2014. In addition, margins
for the year ended December 31, 2015 were negatively impacted by the
decline in the value of the Euro relative to the Company’s reporting
currency, the US dollar, negatively impacting reported gross margins by
approximately 5% when comparing the year ended December 31, 2015 to the
comparable period in 2014.
Operating Expenses
Total operating expenses were $18.5 million and $71.8 million for the
quarter and year ended December 31, 2015, respectively, compared to
$15.9 million and $59.7 million for the quarter and year ended December
31, 2014, respectively. The continued buildout of a U.S. based
commercial team following December 2014 FDA approvals drove the increase
in operating expenses throughout 2015. In addition, label claim
expansion activities over 2015 drove increased costs which were offset
by the decline in activities incurred in 2014 to obtain those December
approvals.
Operating and Net Loss
Operating losses during the fourth quarter of 2015 were $15.0 million,
compared to $12.9 million during the fourth quarter of 2014, and $61.1
million compared to $44.5 million for years ended December 31, 2015 and
2014, respectively.
Net loss for the fourth quarter of 2015 was $14.8 million, or $0.15 per
diluted share, compared to a net loss of $20.2 million, or $0.26 per
diluted share, for the fourth quarter of 2014. Net loss for the year
ended December 31, 2015, was $55.9 million, or $0.61 per diluted share,
compared to a net loss of $38.8 million, or $0.61 per diluted share, for
the same period of 2014.
Net losses for the fourth quarter of 2015 were impacted by the operating
losses discussed above and mark-to-market adjustments of the Company's
then outstanding warrants to fair value, which contributed to the
Company’s net losses by $1.1 million during the quarter ended December
31, 2015, compared to a contribution of $6.6 million to net losses
during the comparable period in 2014. Net losses for the fourth quarter
of 2015 were also favorably impacted by approximately $0.2 million of
foreign exchange gains during the fourth quarter of 2015, compared to
losses of $0.4 million during the corresponding prior period.
Net losses for the year ended December 31, 2015 were impacted by the
operating losses discussed above and mark-to-market adjustments of the
Company's then outstanding warrants to fair value, which reduced the
Company’s net losses by $3.6 million during the year ended December 31,
2015 compared to a reduction to net losses of $7.7 million during the
comparable period in 2014. Net losses for the year were also impacted by
foreign exchange losses of $0.4 million during the year ended December
31, 2015, compared to $1.3 million of foreign exchange losses during the
year ended December 31, 2014.
At December 31, 2015, the Company had no remaining outstanding warrants
and as such, does not expect mark-to-market adjustments going forward.
Cash, Cash Equivalents and Investments
At December 31, 2015, the Company had cash, cash equivalents and
short-term investments of $107.9 million compared to $51.3 million at
December 31, 2014. Included in the 2015 short-term investments are
approximately $11.2 million of marketable equity securities, which had
no recorded value at December 31, 2014.
At December 31, 2015, the Company had approximately $20 million in
outstanding debt under its loan agreement with Oxford Finance.
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 (US)
866-235-9006 or (international) 631-291-4549.
A replay will be available on the company’s web site, or by dialing (US)
855-859-2056 or (international) 404-537-3406 and entering conference ID
number 99594463. (Numbers provided are updated from those included on
our previous release dated February 23, 2016.) The replay will be
available approximately three hours after the call through March 22,
2016.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. The INTERCEPT Blood System is designed to
reduce the risk of transfusion-transmitted infections 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 of the INTERCEPT treatment is designed to inactivate established
transfusion threats, such as hepatitis B and C, HIV, West Nile virus and
bacteria, as well as emerging pathogens such as chikungunya, malaria and
dengue. Cerus currently markets and sells the INTERCEPT Blood System for
both platelets and plasma in the United States, Europe, the Commonwealth
of Independent States, the Middle East and selected countries in other
regions around the world. The INTERCEPT Red Blood Cell system is in
clinical development. See http://www.cerus.com
for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
Acrodose is a trademark of Haemonetics.
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 concerning Cerus’
2016 annual revenue guidance and its expectations for kit demand growth
in 2016; Cerus’ expectations regarding its ability to begin recognizing
revenue from product sales in the United States pursuant to customer
contracts, and the timing thereof; Cerus’ plans to pursue CE Mark
approval in Europe for the red blood cell system and the timing thereof;
the potential for CE Mark approval for red blood cells in Europe; and
the availability and funding of the remaining $10 million term loan
tranche under Cerus‘ loan agreement with Oxford Finance. 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, including the risk that
Cerus may otherwise not experience revenue growth in future periods;
risks associated with Cerus‘ lack of commercialization experience in the
United States and its ability to develop and maintain an effective and
qualified U.S.-based commercial organization, as well as the resulting
uncertainty of its ability to achieve market acceptance of and otherwise
successfully commercialize the INTERCEPT Blood System for platelets and
plasma in the United States; risks related to Cerus‘ ability to
commercialize the INTERCEPT Blood System in the United States without
infringing on the intellectual property rights of others; risks related
to Cerus‘ ability to demonstrate to the transfusion medicine community
and other health care constituencies that pathogen reduction and the
INTERCEPT Blood System is safe, effective and economical; the uncertain
and time-consuming development and regulatory process, including the
risks (a) that Cerus may be unable to comply with the FDA’s
post-approval requirements for the INTERCEPT platelet and plasma
systems, including by successfully completing the required Phase IV
PIPER Study, which could result in a loss of U.S. marketing approval for
the INTERCEPT platelet and/or plasma systems, (b) related to Cerus‘
ability to expand the label claims and product configurations for the
INTERCEPT platelet and plasma systems in the United States, which will
require additional regulatory approvals and (c) that Cerus may be unable
to file for CE Mark approval of the red blood cell system in Europe in
the anticipated timeframe or at all, and even if filed, Cerus may be
unable to obtain CE Mark approval, or any other regulatory approvals, of
the red blood cell system in a timely manner or at all; risks related to
adverse market and economic conditions, including continued or more
severe adverse fluctuations in foreign exchange rates and/or weakening
economic conditions in the CIS and other markets where Cerus sells its
products; Cerus’ reliance on third parties to market, sell, distribute
and maintain its products; Cerus’ ability to maintain an effective
manufacturing supply chain, including the ability of its manufacturers
to comply with extensive FDA and foreign regulatory agency requirements;
the impact of legislative or regulatory healthcare reforms that may make
it more difficult and costly for Cerus to produce, market and distribute
its products; that Cerus may be unable to satisfy the trailing six
months‘ revenue condition to the funding of the final $10 million term
loan tranche under Cerus' loan agreement with Oxford Finance and may
otherwise be unable to maintain (and otherwise comply with the covenants
in) such loan agreement necessary to access the final $10 million term
loan under that agreement; risks related to future opportunities and
plans, including the uncertainty of future revenues and other financial
performance and results, including with respect to Cerus’ potential
inability to meet its 2016 annual revenue guidance, 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 September 30, 2015, filed with the SEC on November 6,
2015. 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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|
|
|
|
|
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Three Months Ended
|
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Twelve Months Ended
|
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|
|
|
December 31,
|
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December 31,
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
$
|
9,656
|
|
|
$
|
9,587
|
|
|
$
|
34,223
|
|
|
$
|
36,416
|
|
|
Cost of revenue
|
|
|
|
6,162
|
|
|
|
6,590
|
|
|
|
23,464
|
|
|
|
21,188
|
|
|
Gross profit
|
|
|
|
3,494
|
|
|
|
2,997
|
|
|
|
10,759
|
|
|
|
15,228
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
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|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
7,160
|
|
|
|
5,186
|
|
|
|
25,643
|
|
|
|
21,800
|
|
|
Selling, general and administrative
|
|
|
|
11,276
|
|
|
|
10,689
|
|
|
|
45,989
|
|
|
|
37,729
|
|
|
Amortization of intangible assets
|
|
|
|
51
|
|
|
|
51
|
|
|
|
202
|
|
|
|
202
|
|
|
Total operating expenses
|
|
|
|
18,487
|
|
|
|
15,926
|
|
|
|
71,834
|
|
|
|
59,731
|
|
|
Loss from operations
|
|
|
|
(14,993
|
)
|
|
|
(12,929
|
)
|
|
|
(61,075
|
)
|
|
|
(44,503
|
)
|
|
Non-operating (expense) income, net:
|
|
|
|
|
|
|
|
|
|
|
(Loss) gain from revaluation of warrant liability
|
|
|
|
(1,132
|
)
|
|
|
(6,555
|
)
|
|
|
3,566
|
|
|
|
7,708
|
|
|
Foreign exchange gain (loss)
|
|
|
|
228
|
|
|
|
(351
|
)
|
|
|
(396
|
)
|
|
|
(1,296
|
)
|
|
Interest expense
|
|
|
|
(644
|
)
|
|
|
(266
|
)
|
|
|
(1,705
|
)
|
|
|
(599
|
)
|
|
Other income, net
|
|
|
|
35
|
|
|
|
24
|
|
|
|
71
|
|
|
|
130
|
|
|
Total non-operating (loss) income, net
|
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|
|
(1,513
|
)
|
|
|
(7,148
|
)
|
|
|
1,536
|
|
|
|
5,943
|
|
|
Loss before income taxes
|
|
|
|
(16,506
|
)
|
|
|
(20,077
|
)
|
|
|
(59,539
|
)
|
|
|
(38,560
|
)
|
|
(Benefit) provision for income taxes
|
|
|
|
(1,750
|
)
|
|
|
105
|
|
|
|
(3,671
|
)
|
|
|
195
|
|
|
Net loss
|
|
|
$
|
(14,756
|
)
|
|
$
|
(20,182
|
)
|
|
$
|
(55,868
|
)
|
|
$
|
(38,755
|
)
|
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Net loss per share:
|
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|
|
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Basic
|
|
|
$
|
(0.15
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(0.52
|
)
|
|
Diluted
|
|
|
$
|
(0.15
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.61
|
)
|
|
$
|
(0.61
|
)
|
|
Weighted average shares outstanding used in the calculation of net
loss per share:
|
|
|
|
|
|
|
|
|
|
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Basic
|
|
|
|
98,209
|
|
|
|
78,808
|
|
|
|
96,068
|
|
|
|
74,767
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|
Diluted
|
|
|
|
98,209
|
|
|
|
78,808
|
|
|
|
96,905
|
|
|
|
76,534
|
|
|
|
|
|
|
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|
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|
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CERUS CORPORATION
CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS
(in thousands)
|
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|
|
|
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|
|
|
December 31,
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
ASSETS
|
|
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Current assets:
|
|
|
|
|
|
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Cash and cash equivalents
|
|
|
$
|
71,018
|
|
|
$
|
22,781
|
|
|
Short-term investments
|
|
|
|
25,698
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|
|
|
28,513
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|
|
Investment in marketable equity securities
|
|
|
|
11,163
|
|
|
|
-
|
|
|
Accounts receivable
|
|
|
|
5,794
|
|
|
|
5,493
|
|
|
Inventories
|
|
|
|
10,812
|
|
|
|
14,956
|
|
|
Prepaid expenses
|
|
|
|
1,166
|
|
|
|
1,210
|
|
|
Other current assets
|
|
|
|
4,788
|
|
|
|
1,932
|
|
|
Total current assets
|
|
|
|
130,439
|
|
|
|
74,885
|
|
|
Non-current assets:
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
|
3,549
|
|
|
|
3,781
|
|
|
Goodwill
|
|
|
|
1,316
|
|
|
|
1,316
|
|
|
Intangible assets, net
|
|
|
|
940
|
|
|
|
1,142
|
|
|
Restricted cash
|
|
|
|
612
|
|
|
|
508
|
|
|
Other assets
|
|
|
|
2,614
|
|
|
|
144
|
|
|
Total assets
|
|
|
$
|
139,470
|
|
|
$
|
81,776
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
|
$
|
5,217
|
|
|
$
|
9,882
|
|
|
Accrued liabilities
|
|
|
|
9,853
|
|
|
|
8,444
|
|
|
Manufacturing and development obligations - current
|
|
|
|
3,282
|
|
|
|
-
|
|
|
Debt - current
|
|
|
|
2,989
|
|
|
|
-
|
|
|
Deferred revenue - current
|
|
|
|
554
|
|
|
|
376
|
|
|
Warrant liability
|
|
|
|
-
|
|
|
|
10,485
|
|
|
Total current liabilities
|
|
|
|
21,895
|
|
|
|
29,187
|
|
|
Non-current liabilities:
|
|
|
|
|
|
|
Debt - non-current
|
|
|
|
16,883
|
|
|
|
9,872
|
|
|
Deferred income taxes
|
|
|
|
122
|
|
|
|
115
|
|
|
Manufacturing and development obligations - non-current
|
|
|
|
4,542
|
|
|
|
-
|
|
|
Other non-current liabilities
|
|
|
|
1,263
|
|
|
|
1,081
|
|
|
Total liabilities
|
|
|
|
44,705
|
|
|
|
40,255
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
Common stock
|
|
|
|
99
|
|
|
|
80
|
|
|
Additional paid-in capital
|
|
|
|
685,189
|
|
|
|
583,416
|
|
|
Accumulated other comprehensive income (loss)
|
|
|
|
7,289
|
|
|
|
(31
|
)
|
|
Accumulated deficit
|
|
|
|
(597,812
|
)
|
|
|
(541,944
|
)
|
|
Total stockholders' equity
|
|
|
|
94,765
|
|
|
|
41,521
|
|
|
Total liabilities and stockholders' equity
|
|
|
$
|
139,470
|
|
|
$
|
81,776
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160308006613/en/
Source: Cerus Corporation