E S S E N T I A L M E D I C I N E
Integration of INTERCEPT Blood System
Into US Blood Safety
US Blood Centers and Hospitals are Choosing the INTERCEPT Blood System to Help Protect Against a Broad Spectrum of Pathogens.
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FDA Takes Action to Mitigate Bacterial Contamination in Platelets
FDA issued Draft Guidance for
1
Bacterial Contamination (March 2016)
Draft guidance recommends pathogen reduction as
an option to mitigate bacterial contamination,
enabling PRT to potentially obviate the need for
culture and point of issue testing.
Final Bacterial Guidance
Expected in 20172
FDA’s CBER announced its list of guidance
documents that it is planning to publish
during 2017, including finalization of the
draft bacterial guidance.
US Industry Guidelines Enable Use of
PRT In Place of Certain Tests, Procedures
AABB Standard 5.19.3.1
to Prevent TA-GVHD
PRT can be used in place of gamma
irradiation to prevent TA-GVHD.
FDA Zika Guidance
PRT can be used in place of Zika testing
for platelet and plasma components.
BARDA Funds Cerus’ RBC Programam
$185 Million over 5-years
The 5-year contract with
Biomedical Advanced
Research and Development
Authority (BARDA) includes
committed funding of $42MM
and subsequent option
periods that would bring the
total non-dilutive funding just
over $185 million.
$185MM
$42MMM
1) Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. Draft Guidance for Industry March 2017 FDA.gov
2) Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2017, January 2017
Dear Shareholder,
Over the past year, Cerus’ business and prospects have advanced fundamentally. In the
U.S., the recent Zika epidemic has underscored the vulnerability of the blood supply to
emerging pathogens, alongside the ongoing risk from bacterial contamination of platelet
concentrates. Globally, we estimate that over four million units of INTERCEPT platelets
and plasma have been produced to date, with some countries relying exclusively on
INTERCEPT for their platelet supply. We remain steadfastly focused on our mission
to make INTERCEPT the standard of care, including the potential future addition of
INTERCEPT red cells to complete the product portfolio, and also collaborating with the
University Hospitals of Geneva and the Swiss Red Cross to make pathogen inactivation
for whole blood a future possibility in Africa.
U.S. Market Progress
Over two million platelet doses are produced annually in the U.S. market, representing
approximately a $150 million market opportunity for INTERCEPT platelets. In 2015, our
sales team was successful in securing contracts with a substantial majority of U.S. blood
centers. Over the course of 2016, we worked with our customers to install illuminators,
train blood center staff to perform the INTERCEPT process, and prepare hospitals to
receive INTERCEPT products.
As of today, illuminators have been installed at most of the 58 sites we have under
contract, for a total of 94 illuminators installed nationwide. Twenty-nine sites have
begun distributing INTERCEPT platelets to their hospital customers. These statistics
reflect substantial progress over the past 12 months (see infographic on overleaf,
“Integration of INTERCEPT Blood System Into US Blood Safety Practices”). A total of
seven Biologics License Applications (BLAs) have now been submitted-- including one by
the American Red Cross. As we begin to see the expected BLA approvals later this year,
INTERCEPT will be available nationwide to any hospital wishing to purchase pathogen
reduced platelets.
A further expected catalyst for the U.S. market is the planned publication of a final
FDA guidance document. The final version of this guidance will officially establish
recommended practices for U.S. blood centers and hospitals to adequately reduce the
risk of bacterial contamination in platelets. The FDA recently confirmed that this is
targeted for 2017 by including it in their annual list of planned guidance documents.
Consistent with the language in the most recent draft, the final guidance is expected
to specify a 12-month implementation period for compliance, as well as universal use
of either pathogen reduction or additional bacterial screening tests. The feedback we
receive from blood centers and hospitals continues to heavily favor use of pathogen
reduction to comply with the new standard.
Large EMEA Opportunities
Building on the base business already established in the Europe, Middle East and
Africa (EMEA) region, we believe we are now positioned to capture meaningful new
opportunities in South Africa and France over the course of 2017.
Pathogen reduction is a natural choice for South Africa, where transfusion-transmitted
infection risks are considerably higher than in other regions. South Africa produces
approximately 65,000 platelet units per year, with over three quarters coming from the
South African National Blood Service, or “SANBS”, and the remainder from the Western
Province Blood Transfusion Service in Cape Town.
France has been considering changes to their standards for bacterial safety of platelets
for several years. Currently no bacterial testing is used, and routine INTERCEPT
production is limited to approximately 10% of the platelet supply, including the Alsace
region and overseas departments. A national decision to address bacterial contamination
would trigger significant practice changes across this large market of approximately
300,000 platelet units per year.
INTERCEPT RBC Program Advancements In Europe And The U.S.
INTERCEPT red blood cells (RBC) would complete the INTERCEPT portfolio and enable
the full potential for pathogen inactivation to safeguard the blood supply against future
transfusion transmitted threats.
Our CE Mark dossier is ready for filing, pending resolution of the commercial lot
release assay results which prevented us from completing this submission in 2016. We
anticipate providing guidance on the revised CE mark submission timing later this year.
The BARDA contract and funding awarded to Cerus in mid-2016 has dramatically
accelerated our INTERCEPT red cell development efforts in the U.S. More recently, we’ve
gained clarity on the scope of the clinical studies required for the PMA submission with
the FDA, and can begin to anticipate our future U.S. launch.
We anticipate that 2017 will be the year in which blood safety in the U.S. and overseas
accelerates its transformation, transitioning from a reactive to a proactive model with
increasing reliance on pathogen reduction methods. We believe that INTERCEPT is well
positioned to continue its market leadership.
Sincerely,
William “Obi” Greenman
President and Chief Executive Officer
April 17, 2017
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(cid:1800) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the fiscal year ended December 31, 2016
OR
(cid:1798) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from to
Commission file number 000-21937
CERUS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
2550 Stanwell Dr.
Concord, California
(Address of principal executive offices)
68-0262011
(I.R.S. Employer
Identification No.)
94520
(Zip Code)
(925) 288-6000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Common Stock, par value $0.001 per share
Name of Each Exchange on Which Registered
The NASDAQ Stock Market LLC
Securities registered pursuant to Section 12(g) of the Act:
Preferred Share Purchase Rights
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (cid:1798) No (cid:1800)
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes (cid:1798) No (cid:1800)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days. Yes (cid:1800) No (cid:1798)
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes (cid:1800) No (cid:1798)
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K, (§229.405 of this chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. (cid:1800)
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “large accelerated
filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer (cid:1798)
Accelerated filer (cid:1800)
Non-accelerated filer (cid:1798)
Smaller reporting company (cid:1798)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:1798) No (cid:1800)
The approximate aggregate market value of the common stock held by non-affiliates of the registrant as of the last business day of the registrant’s most recently
completed second fiscal quarter, based upon the closing sale price of the registrant’s common stock listed on the Nasdaq Global Market, was $543 million. (1)
As of February 24, 2017, there were 103,474,675 shares of the registrant’s common stock outstanding.
Portions of the registrant’s definitive proxy statement in connection with the registrant’s 2017 Annual Meeting of Stockholders, to be filed with the Securities
and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year ended December 31, 2016, are incorporated by reference
into Part III of this Annual Report on Form 10-K.
DOCUMENTS INCORPORATED BY REFERENCE
(1) Based on a closing sale price of $6.24 per share on June 30, 2016. Excludes 14.8 million shares of the registrant’s common stock held by executive officers,
directors and stockholders that the registrant has concluded were affiliates at June 30, 2016.
[THIS PAGE INTENTIONALLY LEFT BLANK]
TABLE OF CONTENTS
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Business .....................................................................................................................................................................
Risk Factors ...............................................................................................................................................................
Unresolved Staff Comments ......................................................................................................................................
Properties ...................................................................................................................................................................
Legal Proceedings ......................................................................................................................................................
Mine Safety Disclosures ............................................................................................................................................
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities ......
Selected Financial Data ..............................................................................................................................................
Management’s Discussion and Analysis of Financial Condition and Results of Operations .....................................
Quantitative and Qualitative Disclosures About Market Risk ...................................................................................
Financial Statements and Supplementary Data ..........................................................................................................
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure .....................................
Controls and Procedures ............................................................................................................................................
Other Information ......................................................................................................................................................
Directors, Executive Officers and Corporate Governance .........................................................................................
Executive Compensation ............................................................................................................................................
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters ...................
Certain Relationships and Related Transactions, and Director Independence ...........................................................
Principal Accountant Fees and Services ....................................................................................................................
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Exhibits and Financial Statement Schedules ..............................................................................................................
69
SIGNATURES ..............................................................................................................................................................................
107
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PART I
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties.
The forward-looking statements are contained principally in Item 1, “Business,” Item 7, “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” and in Item 1A, “Risk Factors.” These statements relate to future events or to
our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may
cause our actual results, performance or achievements to be materially different from any future results, performances or
achievements expressed or implied by the forward-looking statements. These forward-looking statements may include, but are not
limited to, statements about:
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
(cid:120)
future sales of and our ability to effectively commercialize and achieve market acceptance of the INTERCEPT Blood
System, including our ability to comply with applicable United States (U.S.), and foreign laws, regulations and
regulatory requirements;
our ability to manage the growth of our business and attendant cost increases, including in connection with the
commercialization of the INTERCEPT Blood System in the U.S., as well as our ability to manage the risks attendant to
our international operations;
the timing or likelihood of regulatory submissions and approvals and other regulatory actions or interactions,
including our anticipated CE mark submission for the red blood cell system;
our ability to obtain and maintain regulatory approvals of the INTERCEPT Blood System;
our ability to obtain adequate clinical and commercial supplies of the INTERCEPT Blood System from our sole source
suppliers for a particular product or component they manufacture;
the initiation, scope, rate of progress, results and timing of our ongoing and proposed preclinical and clinical trials of
the INTERCEPT Blood System;
the successful completion of our research, development and clinical programs and our ability to manage cost increases
associated with preclinical and clinical development of the INTERCEPT Blood System;
the amount and availability of funding we may receive under our agreement with the Biomedical Advanced Research
and Development Authority, or BARDA;
our ability to transition distribution of the INTERCEPT Blood System from third parties to a direct sales model in
certain international markets;
the ability of our products to inactivate the emerging viruses and other pathogens that we may target in the future;
our ability to protect our intellectual property and operate our business without infringing upon the intellectual
property rights of others; and
our estimates regarding the sufficiency of our cash resources and our need for additional funding.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “will,” “believe,” “estimate,” “expect,”
“plan,” “may,” “should,” “could,” “would,” “project,” “predict,” “potential,” and similar expressions intended to identify such
forward-looking statements. Forward-looking statements reflect our current views with respect to future events, are based on
assumptions, and are subject to risks and uncertainties. There can be no assurance that any of the events anticipated by forward-
looking statements will occur or, if any of them do occur, what impact they will have on our business, results of operations and
financial condition. Certain important factors could cause actual results to differ materially from those discussed in such
statements, including the rate of customer adoption in the U.S. and our ability to achieve market acceptance of our products in the
U.S. and international markets, whether our preclinical and clinical data or data from commercial use will be considered sufficient
by regulatory authorities to grant marketing approval for our products or for product extensions or additional claims for our
products, our ability to obtain reimbursement approval for our products, our ability to complete the development and testing of
additional configurations or redesigns of our products, our need for additional financing and our ability to access funding under
our agreement with BARDA, the impacts of regulation of our products by domestic and foreign regulatory authorities, our limited
experience in sales, marketing and regulatory support for the INTERCEPT Blood System, our reliance on Fresenius Kabi AG and
third parties to manufacture certain components of the INTERCEPT Blood System, incompatibility of our platelet system with
some commercial platelet collection methods, our need to complete our red blood cell system’s commercial design, more effective
product offerings by, or clinical setbacks of, our competitors, product liability, our use of hazardous materials in the development
of our products, business interruption due to earthquake, our expectation of continuing losses, protection of our intellectual
property rights, volatility in our stock price, on-going compliance with the requirements of the Sarbanes-Oxley Act of 2002, and
1
other factors discussed below and under the caption “Risk Factors,” in Item 1A of this Annual Report on Form 10-K. We discuss
many of these risks in this Annual Report on Form 10-K in greater detail in the section titled “Risk Factors” under Part I, Item 1A
below. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking
statements represent our estimates and assumptions only as of the date of this Annual Report on Form 10-K. You should read this
Annual Report on Form 10-K and the documents that we incorporate by reference in and have filed as exhibits to this Annual
Report on Form 10-K completely. Our actual future results may be materially different from what we expect. Except as required by
law, we assume no obligation to update or revise any forward-looking statements to reflect new information or future events, even
if new information becomes available in the future. You should not assume that our silence over time means that actual events are
bearing out as expressed or implied in such forward-looking statements.
Item 1.
Business
Overview
We are a biomedical products company focused on developing and commercializing the INTERCEPT Blood System to enhance blood
safety. The INTERCEPT Blood System, which is based on our proprietary technology for controlling biological replication, is
designed to reduce blood-borne pathogens in donated blood components intended for transfusion.
Our INTERCEPT Blood System is for use with three blood components: plasma, platelets, and red blood cells. The INTERCEPT
Blood System for platelets, or platelet system, and the INTERCEPT Blood System for plasma, or plasma system, have received a
broad range of regulatory approvals, including but not limited to U.S. Food and Drug Administration, or FDA, approval in the U.S.,
and Class III CE marks in the European Union and other jurisdictions that recognize CE mark approval, and are being marketed and
sold in a number of countries around the world, including the U.S.; certain countries in Europe, the Commonwealth of Independent
States, or CIS, the Middle East, and Latin America and selected countries in other regions of the world. We sell both the platelet and
plasma systems using our direct sales force and through distributors. If we are unable to gain widespread commercial adoption in
markets where our blood safety products are approved for commercialization, including in the U.S., we will have difficulties achieving
profitability.
The INTERCEPT Blood System for red blood cells, or the red blood cell system, is currently in development. In late 2014 and early
2015, we announced that both our U.S. Phase II recovery and lifespan study of the red blood cell system and our European Phase III
clinical trial of the red blood cell system for acute anemia patients met their respective primary endpoints. Based on the results of the
European Phase III acute anemia clinical trial, we plan to file for CE mark approval of the red blood cell system in the European
Union.
In order to successfully commercialize all of our products and product candidates, we will be required to conduct significant research,
development, preclinical and clinical evaluation, commercialization and regulatory compliance activities for our products and product
candidates, which, together with anticipated increased selling, general and administrative expenses, are expected to result in
substantial losses. Accordingly, we may never achieve a profitable level of operations in the future.
We were incorporated in California in 1991 and reincorporated in Delaware in 1996. Our wholly-owned subsidiary, Cerus Europe
B.V., was formed in the Netherlands in 2006. Information regarding our revenue, net loss, and total assets for the last three fiscal years
can be found in the consolidated financial statements and related notes found elsewhere in this Annual Report on Form 10-K.
Product Development
Background
The INTERCEPT Blood System is designed to broadly target and inactivate blood-borne pathogens, such as viruses (for example,
HIV, West Nile, SARS, hepatitis B and C), bacteria and parasites, as well as potentially harmful white blood cells, while preserving
the therapeutic properties of platelet, plasma and red blood cell transfusion products. The INTERCEPT Blood System has been shown
to inactivate a broad array of pathogens and has the potential to reduce the risk of transfusion related transmission of pathogens for
which testing is not completely effective, is not available or is not performed. We believe that the INTERCEPT Blood System also has
the potential to inactivate most new pathogens before they are identified and before tests are developed and adopted commercially to
detect their presence in donated blood.
2
Products, Product Candidates and Development Activities
The following table identifies our products, product candidates and product development activities and their current status:
Product or Product Candidate Under Development
Product or Development Status
INTERCEPT Blood System—Platelets
(cid:120) Commercialized in the U.S. and a number of countries in Europe, the CIS, the
Middle East, and selected countries in other regions around the world
INTERCEPT Blood System—Plasma
(cid:120) Commercialized in the U.S. and a number of countries in Europe, the CIS, the
Middle East, and selected countries in other regions around the world
INTERCEPT Blood System—Red Blood
Cells
(cid:120) Phase I clinical trial completed in 2010
(cid:120) European Phase III clinical trial for acute anemia and U.S. Phase II recovery and
lifespan study completed in 2014
(cid:120) European chronic anemia clinical trial ongoing
(cid:120) European CE mark submission planned
(cid:120) Further U.S. in vitro studies planned
INTERCEPT Blood System for Platelets and Plasma
The platelet system and plasma system are designed to inactivate blood-borne pathogens in platelets and plasma donated for
transfusion. Both systems received CE mark approval in Europe and are currently marketed and sold in a number of countries around
the world including the U.S., Europe, the CIS, the Middle East and selected countries in other regions of the world. Separate approvals
for use of INTERCEPT-treated platelet and plasma products have been obtained in France and Switzerland. In Germany and Austria,
where approvals must be obtained by individual blood centers for use of INTERCEPT-treated platelets and plasma, several centers
have obtained such approvals for use of INTERCEPT-treated platelets and one center has obtained such approval for use of
INTERCEPT-treated plasma. Many countries outside of Europe accept the CE mark and have varying additional administrative or
regulatory processes that must be completed before the platelet system or plasma system can be made commercially available. In
general, these processes do not require additional clinical trials. Regardless, some potential customers may desire to conduct their own
clinical studies before adopting the platelet system or plasma system.
The FDA has approved the platelet system for ex vivo preparation of pathogen-reduced apheresis platelet components in order to
reduce the risk of transfusion-transmitted infection, or TTI, including sepsis, and to potentially reduce the risk of transfusion-
associated graft versus host disease. As part of the FDA’s approval of the platelet system, we are required to successfully conduct and
complete a post-approval haemovigilance study to evaluate the incidence of acute lung injury following transfusion of INTERCEPT
treated platelets. The first patient enrolled in that study in December 2015. The FDA has also approved the plasma system for ex vivo
preparation of plasma in order to reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion.
We are commercializing the plasma and platelet systems in the U.S. and will be largely focused on implementing INTERCEPT to
customers with whom we have previously signed agreements and developing awareness of INTERCEPT’s product profile relative to
other platelet and plasma products, including conventional, un-treated products. Prior to broader customer adoption in the U.S., U.S.-
based blood centers will need to complete their process validations and obtain site-specific licenses from the FDA Center for
Biologics Evaluation and Research, or CBER, before making INTERCEPT-treated blood products available to their interstate hospital
customers. Several blood centers have submitted for their interstate licenses. Until those licenses are obtained, U.S. blood centers will
be limited to sales to hospital customers within the state in which the INTERCEPT-treated platelets or plasma are processed. Further,
the hospital customers of these blood centers will need to go through the administrative process of generating internal tracking codes
to integrate INTERCEPT-treated products into their inventories, which may further delay customer adoption in the U.S. In addition, in
order to address the entire market in the U.S., we will need to develop, test and obtain FDA approval of additional configurations of
the platelet system. For example, in the U.S., we understand a significant number of platelet concentrates are derived from larger
volumes collected from apheresis donors split into three therapeutic transfusable doses, or triple doses. Future configurations of the
platelet system will be needed to treat platelet donations with such processing parameters. In addition, we understand that a significant
portion of the U.S. blood centers store their platelet components suspended in 100% plasma. Further, we estimate that the majority of
platelets used in the U.S. are collected by apheresis, which is part of our FDA-approved label for the platelet system, though a
significant minority are prepared from pooled random donor platelets derived from whole blood collections. In order to gain FDA
approval for a pathogen reduction system compatible with triple dose collections and random donor platelets, we will need to perform
additional product development and testing, including additional clinical trials, and will need to obtain FDA approval of a premarket
3
application, or PMA supplement. These development activities will be costly and may not be successful. Our failure to obtain FDA
and foreign regulatory approvals of these new configurations could significantly limit revenues from sales of our products.
In 2015, we conducted a Phase I clinical study protocol under an investigational device exemption, or IDE, to treat plasma derived
from convalesced patients that were previously infected with the Ebola virus and had recovered from the disease according to the
criteria set by the Centers for Disease Control and Prevention. The transfusion of convalesced plasma from Ebola survivors is believed
to pass on antibodies to the disease from the survivor to the recipient of the plasma transfusion. INTERCEPT use under this IDE was
limited to pathogen reduction claims that relied on existing clinical data that we had regarding reduction of certain pathogens in
donated plasma. Following the conclusion of this study, we did not have any clinical or commercial data on the efficacy of
INTERCEPT to inactivate the Ebola virus and therefore do not know the effectiveness of INTERCEPT to inactivate the Ebola virus.
INTERCEPT Blood System for Red Blood Cells
The red blood cell system is designed to inactivate blood-borne pathogens in red blood cells donated for transfusion. We completed a
series of in vitro and in vivo tests with the red blood cell system, including successfully completing recovery and survival studies
measuring red cell recovery twenty-four hours after transfusion. Previously, we terminated Phase III clinical trials for acute and
chronic anemia using a prior generation of the red blood cell system due to the detection of antibody reactivity to INTERCEPT-treated
red blood cells in two patients in the trial for chronic anemia. The antibody eventually cleared and the patients had no adverse health
consequences. After unblinding the data from the original Phase III clinical trials, we found that we had met the primary end-point in
the clinical trial for acute anemia. We evaluated the antibodies detected and developed process changes to diminish the likelihood of
antibody reactivity in red blood cells treated with our modified process. There has been no antibody reactivity associated with
INTERCEPT-treated red blood cells in any of the subsequent configurations, studies or trials we have completed since modifying the
process used in the red blood cell system. Accordingly, we received authorization from European regulators to proceed with Phase III
clinical trials for acute anemia and, separately, chronic anemia. Although the Phase III clinical trial of the red blood cell system in
Europe for chronic anemia patients is ongoing, we successfully completed the Phase III clinical trial of the red blood cell system for
acute anemia patients and plan to submit for CE mark approval.
In January 2015, we announced that the completed Phase III clinical trial of red blood cells treated with the INTERCEPT Blood
System for acute anemia in cardiovascular surgery patients met its primary endpoint, with preliminary analysis demonstrating that the
mean hemoglobin content (53.1g) of INTERCEPT-treated red blood cell components, or RBCs, on day 35 of storage met the protocol-
defined criteria for equivalence based on the inferiority margin of 5g compared to conventional RBCs (55.8g). The randomized,
double-blind, controlled, multi-center Phase III clinical trial of the red blood cell system evaluated the efficacy of the red blood cell
system to process RBCs with quality and mean hemoglobin content (>40 g) suitable to support transfusion according to the European
Directorate for the Quality of Medicines. The blood components were transfused to 51 cardiovascular surgery patients at two German
clinical trial sites to evaluate transfusion efficacy and overall safety. There were no clinically relevant trends in severe or serious
treatment related adverse events by system organ class. The observed adverse events were within the expected spectrum of co-
morbidity and mortality for patients of similar age and with advanced cardiovascular diseases undergoing cardiovascular surgery
requiring red cell transfusion. No patients exhibited an immune response to INTERCEPT-treated RBCs. Based on the results of this
trial, we plan to file for CE mark approval in the European Union. We understand that while the acute anemia Phase III clinical trial in
Europe may be sufficient to receive CE mark approval in the European Union, we may need to generate additional safety data from
commercial use and/or achieve a successful outcome in the ongoing chronic anemia Phase III clinical trial for our red blood cell
system in order to achieve broad market acceptance. As part of our development and chemistry, manufacturing and control, or CMC,
activities, we will need to successfully complete validation studies on sufficient quantities of the final red blood cell system prior to
receiving any regulatory approvals in Europe.
In the U.S., we successfully completed a Phase II recovery and lifespan study in 2014. In 2016, we reached agreement with the FDA
on a clinical trial protocol, known as RedeS, which is assessing safety in six-hundred (600) patients receiving red blood cell
transfusions in regions heavily impacted by the Zika virus epidemic. The controlled, randomized, double-blind clinical trial will be
conducted in Puerto Rico and Florida. In addition, we will need to successfully conduct and complete a separate license-enabling
Phase III clinical trial in the U.S. before the FDA will consider our red blood cell product for approval. We also understand that one or
more additional in vitro studies will be required to be successfully completed and submitted to the FDA prior to any initiation of a
potential Phase III clinical trial. There can be no assurance that we will be able to successfully satisfy any such in vitro studies, nor can
there be any assurance that we and the FDA will agree to any trial protocol we propose or that we will otherwise obtain FDA
clearance to initiate a potential Phase III clinical trial. We also understand that the FDA will require us to place a clinical hold on any
clinical trial if we see a hemolytic reaction associated with treatment with emergent antibodies with amustaline specificity in patients
receiving INTERCEPT-treated red blood cells in that trial. Should we experience such an incident, we will need to investigate the
underlying cause of the hemolytic reaction, which in many patient populations may be difficult for us to assess imputability which
may lead to a complete halt of the clinical trial, may irreparably harm our red blood cell product’s reputation and we may be forced to
suspend or terminate development activities related to the red blood cell system in the U.S., which would have a material adverse
4
effect on our business and business prospects. We also plan to complete certain other prerequisites, as well as to complete our
development and CMC activities in order to proceed with our planned CE mark submission.
Additional information regarding our interactions with the FDA, and potential future clinical development of the INTERCEPT Blood
System in Europe and in the U.S. can be found under “Item 1A—Risk Factors” of this Annual Report on Form 10-K, under the risk
factor titled “Our products, blood products treated with the INTERCEPT Blood System and we are subject to extensive regulation by
domestic and foreign authorities. If our preclinical and clinical data are not considered sufficient by a country’s regulatory
authorities to grant marketing approval, we will be unable to commercialize our products and generate revenue in that country. Our
investigational red blood cell system requires extensive additional testing and development.”
Information regarding our revenues for the years ended December 31, 2016, 2015 and 2014 can be found in “Item 7— Management’s
Discussion and Analysis of Financial Condition and Results of Operations”, and “Financial Statement Schedules—Financial
Statements” of this Annual Report on Form 10-K.
INTERCEPT Blood System Technology
Both our platelet system and plasma system employ the same technology. Platelet or plasma components collected from blood donors
are transferred into plastic INTERCEPT disposable kits and are mixed with our proprietary compound, amotosalen, a small molecule
compound that has an affinity for nucleic acid.
The disposable kits are then placed in an illumination device, or illuminator, where the mixture is exposed to ultra-violet A, or UVA,
light. If pathogens such as viruses, bacteria or parasites, as well as leukocytes, or white cells, are present in the platelet or plasma
components, the energy from the UVA light causes the amotosalen to bond with the nucleic acid. Since platelets and plasma do not
rely on nucleic acid for therapeutic efficacy, the INTERCEPT Blood System is designed to preserve the therapeutic function of the
platelet and plasma components when used in human transfusions.
The ability of amotosalen to form both cross-links between strands of nucleic acid and links to single nucleic acid strands results in a
strong chemical bond between the amotosalen and the nucleic acid of the pathogens. The presence of these bonds is designed to
prevent replication of the nucleic acid within pathogens, effectively inactivating the pathogens. A high level of inactivation has been
demonstrated in a broad range of pathogens studied by us and others in laboratory testing. For instance, INTERCEPT has
demonstrated inactivation of a number of single stranded nucleic acid-based viruses such as HIV, hepatitis B, hepatitis C (using a
model virus), West Nile, chikungunya and certain influenza viruses.
Following the inactivation process, residual amotosalen and by-products are reduced by more than 99% through use of a compound
adsorption device, which is an integrated component of the disposable kit. We have performed extensive toxicology testing on the
residual amotosalen and its by-products and good safety margins have been demonstrated. Any remaining amotosalen which may be
transfused, should any exist, is rapidly excreted by humans.
Leukocytes, also known as white blood cells, are typically present in platelet and plasma components collected for transfusion and can
cause adverse transfusion reactions as well as an often fatal disease called graft-versus host disease. Leukocytes, like pathogens, rely
on nucleic acid for replication and cellular function. The INTERCEPT Blood System, with its combination of the amotosalen and
UVA light, is designed to inactivate leukocytes in the same manner it inactivates pathogens.
Like the platelet and plasma systems, the red blood cell system is designed to prevent pathogen replication by using a small molecule
additive compound to form bonds with nucleic acid in pathogens that may be present in donated red blood cell collections. The red
blood cell system is designed to preserve the therapeutic qualities of the red blood cells, which, like platelets and plasma, do not rely
on nucleic acid for their therapeutic efficacy. The red blood cell system uses another of our proprietary compounds, amustaline.
Unlike the platelet and plasma systems, the chemical bonds from amustaline are not triggered by UVA light, but instead, by the pH
level of the red blood cell components. After mixture with the red blood cell components in plastic disposable kits and resulting
nucleic-acid bonding, amustaline is designed to rapidly break down into a form that is no longer chemically reactive with nucleic acid.
As with the platelet and plasma systems, a high level of inactivation in a broad range of pathogens has been demonstrated with the red
blood cell system in the clinical setting. We plan on conducting additional pathogen-inactivation studies of the red blood cell system,
broadening our understanding of the pathogens the system may be able to inactivate.
By treating blood components with INTERCEPT within a day of collection, the inactivation of bacteria prevents bacterial growth that
could create increased risk of inflammatory response or dangerous levels of endotoxins. Extensive clinical testing has been done on
platelet and plasma products treated with the INTERCEPT Blood System, as well as post-marketing haemovigilance studies of the
treated blood products in routine use.
5
We believe that, due to their mechanisms of action, the platelet system, plasma system, and red blood cell system will potentially
inactivate blood-borne pathogens that have not yet been tested with our systems, including emerging and future threats to the blood
supply. We do not claim, however, that our INTERCEPT Blood System will inactivate all pathogens, including prions, and our
inactivation claims are limited to those contained in our product specifications. There can also be no assurance that INTERCEPT will
inactivate even those pathogens where claims exist, in every instance or under every processing condition.
Investment in Aduro Biotech
In connection with the agreements to license certain immunotherapy technologies to Aduro Biotech Inc., or Aduro, in 2009, we
received shares of preferred stock of Aduro, a privately held company at that time. Pursuant to these license agreements, we are
eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. For the years ended December 31,
2016, 2015 and 2014, we have not received any royalty payments from Aduro pursuant to these license agreements. In April 2015,
Aduro’s common stock began trading on the NASDAQ Global Select Market, under the symbol “ADRO”. At the time of Aduro’s
initial public offering, our preferred shares in Aduro converted into common stock. William Greenman, our President and Chief
Executive Officer, is a member of the Board of Directors of Aduro in his individual capacity and does not represent our interests.
Manufacturing and Supply
We have used, and intend to continue to use, third parties to manufacture and supply the devices, disposable kits and inactivation
compounds that make up the INTERCEPT Blood System for use in clinical trials and for commercialization. We rely solely on
Fresenius Kabi AG, or Fresenius, for the manufacture of INTERCEPT Blood System for platelet and for plasma disposable kits and
on other contract manufacturers for the production of our inactivation compounds, compound adsorption components of the
disposable kits and illuminators used in the INTERCEPT Blood System. We currently do not have alternate manufacturers for the
components in our products or product candidates beyond those that we currently rely on, but we are currently in the process of
identifying potential alternate manufacturers. In October 2015, we amended and restated our manufacturing and supply agreement
with Fresenius with the new terms effective July 1, 2015. Under the amended agreement, Fresenius is obligated to sell, and we are
obligated to purchase finished disposable kits for the platelet, plasma and red blood cell systems from Fresenius for both clinical and
commercial use. The amended and restated agreement permits us to purchase platelet, plasma and red blood cell systems from third
parties to the extent necessary to maintain supply qualifications with such third parties or where local or regional manufacturing is
needed to obtain product registrations or sales. Pricing terms are initially fixed and decline at specified annual production levels. The
amended and restated agreement also contemplates that we and Fresenius will jointly fund and collaborate on certain specified
initiatives focused on new product development or enhancements, potential implementation of automation, installation of new
equipment, capacity expansion and cost reduction. We are required to make contributions toward those joint collaboration projects in
certain specified installment amounts. In addition, we will make a one-time, lump sum payment, or the Milestone Payment, to
Fresenius at the earlier of achievement of certain production volumes or a specified mutually agreed date. Under the amended and
restated agreement, we are no longer required to make royalty payments to Fresenius for the sale of products after June 30, 2015. The
term of the amended and restated manufacturing and supply agreement with Fresenius extends through July 1, 2025, and will
automatically renew for successive additional two year periods unless terminated by either party upon two years’ prior written notice,
in the case of the initial term, or one year prior written notice, in the case of any renewal term. We and Fresenius each have normal
and customary termination rights, including termination for material breach.
Components of compound adsorption devices used in platelet and plasma disposable kits are manufactured by Porex Corporation, or
Porex. The term of our supply agreement with Porex has been extended until March 31, 2017 to allow us and Porex to negotiate a
mutually agreeable amendment to our supply agreement. Although we are actively seeking to develop alternative manufacturers and
components, commercially viable alternatives are likely several years away.
We also have contracts with suppliers of raw materials used to make the compound adsorption devices, which includes such
companies as Brotech Corporation d/b/a Purolite Company, or Purolite. Our supply agreement with Purolite extends through April
2021.
Pursuant to a contract that we and NOVA Biomedical Corporation, or NOVA, entered into in September 2008, NOVA is
manufacturing illuminators for us. The term of our agreement with NOVA automatically renews for successive one year terms each
September in the event neither party delivers written notice of its intent to terminate twelve months prior to each September renewal
date. We do not currently have plans to terminate our agreement with NOVA and believe that NOVA currently plans to continue
operating under the agreement for the foreseeable future.
We operate with an amended manufacturing and supply agreement with Ash Stevens, Inc., or Ash Stevens, for the synthesis of
amotosalen, the inactivation compound used in our platelet and plasma systems. Under this amended agreement, we are not subject to
minimum annual purchase requirements. However, if specified quantities of amotosalen are not purchased in any year, we are required
6
to pay a maintenance fee of up to $50,000 for such year. We have incurred these maintenance fees in the past. The original term of the
amended manufacturing and supply agreement with Ash Stevens extends through December 31, 2017, and will continue to
automatically renew for successive two year periods, unless terminated by either party upon providing at least one year prior written
notice, in our case, or at least two years prior written notice, in the case of Ash Stevens. Neither party has delivered notice of its intent
to terminate the agreement.
We and our contract manufacturers, including Fresenius and NOVA, purchase certain raw materials for our disposable kits,
inactivation compounds, materials and parts associated with compound adsorption devices and UVA illuminators from a limited
number of suppliers. Some of our suppliers require minimum annual purchase amounts. While we believe that there are alternative
sources of supply for such materials, parts and devices, we have not validated or qualified any alternate manufacturers. As such,
establishing additional or replacement suppliers for any of the raw materials, parts and devices, if required, will likely not be
accomplished quickly and could involve significant additional costs and potential regulatory reviews. For example, we understand
that certain plastics used to make INTERCEPT disposable kits will only be available for a finite period of time. As a result, we and
our manufacturers have identified alternate plastics but will need to qualify and validate those plastics before we can utilize them in
commercial manufacturing.
Marketing, Sales and Distribution
The market for the INTERCEPT Blood System, including the U.S. market, is dominated by a relatively small number of blood
collection organizations. Accordingly, there may be an extended period during which some potential U.S.-based customers may first
choose to validate our technology or run experience studies themselves before deciding to adopt the system for commercial use, which
may never occur. The American Red Cross represents the largest single portion of the blood collection market in the U.S. While we
believe adoption of the INTERCEPT Blood System will afford the American Red Cross with many benefits, we cannot guarantee the
volume or timing of commercial purchases that the American Red Cross may make, if any, under our multi-year commercial
agreement that we and the American Red Cross entered into in February 2016. Furthermore, the U.S. blood banking market is
undergoing consolidation which may continue and further concentrate the potential customer base. In many countries in Western
Europe and in Japan, various national blood transfusion services or Red Cross organizations collect, store and distribute virtually all of
their respective nations’ blood and blood components supply. The largest European markets for our products are in Germany, France,
and England.
In Germany, decisions on product adoption are made on a regional or blood center-by-blood center basis. While obtaining CE marks
allow us to sell the platelet and plasma systems to blood centers in Germany, blood centers in Germany must still obtain both local
manufacturing approval and national marketing authorization from the Paul Ehrlich Institute or PEI, a German governmental
regulatory body overseeing the marketing authorization of certain medical products, before being allowed to sell platelet and plasma
components treated with the INTERCEPT Blood System to transfusing hospitals and physicians. To date, several blood centers in
Germany have received such requisite approvals and authorizations for the platelet system and one blood center has received such
approval for the plasma system. Given the competitive nature of the German blood banking market, pricing for blood components is
relatively low compared to other markets. This dynamic, in turn, requires us to focus our marketing efforts on the potential economic
and logistical benefits of using INTERCEPT compared to conventional blood components as well as the potential safety benefits of
INTERCEPT-treated blood components.
In France, broad product adoption is dependent on a central decision by the Établissement Français du Sang, or EFS, a public
organization responsible for all collection, testing preparation and distribution of blood products in France, and then on a broad-based
national supply contract being awarded. In December 2015, we entered into a new two-year framework contract with the EFS to
supply platelet and plasma disposable kits.
In England, decisions on product adoption are centralized in the National Blood Service, or NHSBT, which collects, tests, processes
and supplies blood products to hospitals in England and North Wales. The National Blood Service has implemented and used bacterial
detection for platelets for the past several years instead of pathogen inactivation. More recently, the National Blood Service has
implemented the INTERCEPT Blood System for platelets in one of its centers for validation of the technology. In July 2015, the
National Blood Service issued a public tender to solicit bids for both pathogen inactivation and bacterial detection, to which we
responded. In December 2015, the National Blood Service announced that it had terminated the potential tender for pathogen
inactivation. We do not know when, if ever, the NHBST will consider adoption of a product for pathogen reduction, including
INTERCEPT.
In Japan, the Japanese Red Cross controls a significant majority of blood centers and exerts a high degree of influence on the adoption
and use of blood safety measures in Japan. The Japanese Red Cross has been reviewing preclinical and clinical data on pathogen
reduction of blood over a number of years and has yet to make a formal determination to adopt any pathogen reduction approach. We
also understand that the Japanese Red Cross has begun formal evaluation of a competing technology. Before the Japanese Red Cross
7
considers our products, we understand that we may need to complete certain product configuration changes, which are currently under
development but may not be economically or technologically feasible for us to complete.
Market adoption of our products is affected by blood center and healthcare facility budgets and the availability of reimbursement from
governments, managed care payors, such as insurance companies, and/or other third party payors. In many jurisdictions, budget and
reimbursement discussions generally occur among blood centers, healthcare facilities such as hospitals, national or regional ministries
of health and private payors. Even if a particular blood center is prepared to adopt the INTERCEPT Blood System, its hospital
customers may not accept or may not have the budget to purchase INTERCEPT-treated blood products. Since blood centers would
likely not eliminate the practice of screening donors or testing blood for some pathogens prior to transfusion, even after implementing
our products, our ability to successfully commercialize our products will depend in part on helping blood centers to identify enough
cost offsets or hospital pricing increases to afford to purchase our products. Budgetary concerns may be further exacerbated by
economic legislation in certain countries and by proposals by legislators at both the U.S. federal and state levels, regulators, healthcare
facilities and third party payors to keep healthcare costs down, which may limit the adoption of new technologies, including our
products. In the U.S., the costs and expenses incurred by the blood center related to donor blood are typically included in the price that
the blood center charges a hospital for a unit of blood. The Centers for Medicare & Medicaid Services published a separate
reimbursement code and premium pricing for pathogen-reduced platelet and plasma components under the Healthcare Common
Procure Coding System, or HCPCS. After 2017, the reimbursement pricing for our products under HCPCS will be driven by actual
costs charged to hospitals for INTERCEPT-treated components.
We maintain a wholly-owned subsidiary, Cerus Europe B.V., headquartered in the Netherlands, which focuses its efforts on marketing
and selling the INTERCEPT Blood System in a number of countries in Europe, the CIS, the Middle East and selected countries in
other regions around the world. We have a small scientific affairs group in the U.S. and the Netherlands that supports our
commercialization efforts as well as medical science liaisons, or MSLs, to help educate hospitals and physicians on our products,
clinical trial history and publications. We have a small number of employees focused on servicing the markets in Asia-Pacific and
Latin American regions and rely primarily on distributors to market and sell our products in those regions.
We have entered into distribution agreements, generally on a geographically exclusive basis, with distributors in countries where we
have limited abilities to commercialize our products directly. In certain of these jurisdictions, we rely on these distributors to obtain
any necessary in-country regulatory approvals, in addition to marketing and selling the INTERCEPT Blood System, providing
customer and technical product support, maintaining inventories, and adhering to our quality system in all material respects, among
other activities. Selected areas where we have entered into geographically exclusive distribution agreements include but are not
limited to certain countries in the CIS, Italy, the Middle East, Latin America, South Africa and Southeast Asia, as well as the People’s
Republic of China. Our success in these regions is dependent on our ability to support our distributors and our distributor’s ability to
market and sell our products and to maintain and service customer accounts, including technical service. Our distribution agreements
account for a significant amount of our revenues. As such, declining performance or the outright termination or loss of certain
distributor relationships could harm our existing business, may impact our growth potential, and could result in higher operating costs
for us. As our distributors play a critical role in our commercialization efforts, we evaluate their performance on an ongoing basis. As
we continue to evaluate our distributors, we may take further actions in the future which may have an impact on our operating results.
For instance, over the course of 2013 and 2014, we implemented several changes designed to improve market penetration in our
distributor territories, including by adding additional sales, technical and marketing support, as well as by providing supplementary
training to improve the effectiveness of distributor field personnel. In 2014, we began transitioning certain territories to new
distribution partners who we felt were capable of improved performance relative to their predecessors as well as transitioned some of
these territories to a Cerus direct sales effort, which we believed would provide us with better visibility into and control of sales
execution. As a result of these changes, we experienced a decrease in the volume of INTERCEPT disposable kit sales for the impacted
territories as those distribution partners sold through their disposable kit inventory. In addition, the new distributors and our own direct
sales force continue to require some time to develop the market with the same proficiency as previous distributors. We cannot provide
assurance that they will be successful in achieving the same level of operations or proficiency as our previous distributors. We expect
that it may take longer for us to be paid with some distributors or customers taking longer to pay invoices than the payment terms we
have historically experienced.
8
Government Contracts
Revenue from the cost reimbursement provisions under our government contracts varies by year. A portion of our government
contracts revenue is subject to renegotiation of reimbursement rates or termination of contracts or subcontracts at the election of the
U.S. government. In addition, U.S. government contracts typically contain unfavorable provisions and are subject to audit and
modification by the government at its sole discretion. Generally, government contracts, including our agreement with BARDA,
contain provisions permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience. See
Note 2 in the Notes to Consolidated Financial Statements under “Financial Statement Schedules—Financial Statements” of this
Annual Report on Form 10-K for information on our government contract revenue and other financial information for the years ended
December 31, 2016, 2015 and 2014. Further discussion of the factors impacting our government contracts revenue and the related
impact on our ability to operate our business can be found under “Item 1A—Risk Factors” of this Annual Report on Form 10-K, under
the risk factors titled “A significant portion of the funding for the development of the red blood cell system is expected to come from
our BARDA agreement, and if BARDA were to eliminate, reduce or delay funding from our contract, this could have a significant,
negative impact on our revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development
program or obtain alternative sources of funding” and “Unfavorable provisions in government contracts, including in our contract with
BARDA, may harm our business, financial condition and operating results.”
Competition
Our products face a wide variety of competition from entities competing directly with alternative pathogen reducing technologies for
platelets and/or plasma, as well as from entities developing and selling diagnostic screening products to detect and prevent
contaminated products from being transfused, and from process and procedural decisions involving blood banking operations
including but not limited to shortened shelf-life of blood components. Many of our competitors have mature, well-established products
or have other products which are sold to blood centers and many have more commercial resources than we do. In addition,
competitors may choose to seek a lower class of approval than our products, which may be easier and less costly for them to maintain
and may be perceived as sufficient by the marketplace. We believe that the INTERCEPT Blood System has certain competitive
advantages over competing blood-borne pathogen reduction methods that are either on the market or in development. The
INTERCEPT Blood System is designed for use in blood centers, which allows for integration with current blood collection,
processing and storage procedures. Certain competing products currently on the market, such as solvent detergent-treated plasma, use
centralized processing that takes blood products away from the blood center in order to be treated at a central facility before being
shipped back out to the blood centers or hospitals for ultimate transfusion, which may result in higher costs.
In Europe, several companies, including Grifols S.A., Octapharma AG, MacoPharma International and Kedrion Biopharma, are
developing or selling commercial pathogen reduction systems or services to treat fresh frozen plasma. Terumo BCT, a subsidiary of
Terumo Corporation, has developed a pathogen reduction system for blood products and has been issued Class II CE marks for such
system for both platelets and plasma. MacoPharma has received a CE mark for a UVC-based pathogen reduction product for platelets.
MacoPharma currently has a Phase III clinical trial underway in Germany to generate additional data for expanded approvals. We
understand that Terumo BCT also developed a pathogen reduction system for whole blood, receiving a Class II CE mark. Terumo
BCT’s product candidates, if successful, may offer competitive advantages over our INTERCEPT Blood System.
In the U.S., INTERCEPT-treated plasma faces competition from Octapharma AG, which received approval from the FDA to begin
selling treated fresh frozen plasma, as well as from diagnostic and testing companies currently approved for the detection of pathogens
in donated blood products, including bacterial and viral pathogens. Our platelet product faces competition from a number of diagnostic
and testing companies currently approved for the detection of pathogens including bacterial and viral pathogens in donated blood
products and may face competition from other technologies if approved.
In Japan, we understand that Terumo BCT’s platelet and plasma pathogen reduction product is currently being evaluated by the
Japanese Red Cross. Terumo Corporation is a large Japan-based, multinational corporation with more mature products and
relationships than we have. Our ability to commercialize our products in certain markets, particularly in Japan, may be negatively
affected by Terumo’s resources and their pre-existing relationships with regulators and customers. Should Terumo BCT’s product be
approved for use and commercialized in Japan, we would likely directly compete with them and we believe we would likely need to
either establish operations in Japan or partner with a local Japanese company.
We believe that the primary competitive factors in the market for pathogen reduction of blood products include the breadth and
effectiveness of pathogen reduction processes, the amount of demonstrated reduction in transfusion related adverse events subsequent
to adopting pathogen reduction technology, robustness of treated blood components upon transfusion, the scope and enforceability of
patent or other proprietary rights, perceived product value relative to perceived risk, product supply, perceived ease of use, perception
of safety, efficacy and economics of pathogen reduction systems, and marketing and sales capability. In addition, we believe the
length of time required for products to be developed and to receive regulatory and, in some cases, reimbursement approval are also
9
important competitive factors. We believe that the INTERCEPT Blood System will compete favorably with respect to these factors,
although there can be no assurance that it will be able to do so. Our success will depend in part on our ability to convince prospective
customers of the benefits of and need to adopt pathogen reduction technology and specifically our system relative to other
technologies, our ability to obtain and retain regulatory approvals for our products, and our ability to continue supplying quality and
effective products to our customers and prospective customers.
Further discussion of the major competitors to our blood product business can be found under “Item 1A—Risk Factors” of this Annual
Report on Form 10-K, under the risk factor titled “If our competitors develop products superior to ours, market their products more
effectively than we market our products, or receive regulatory approval before our products, our commercial opportunities could be
reduced or eliminated.”
Patents, Licenses and Proprietary Rights
Our commercial success will depend in part on our ability to obtain patents, to protect trade secrets, to operate without infringing upon
the proprietary rights of others and to prevent others from infringing on our proprietary rights. Our policy is to seek to protect our
proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology,
inventions and improvements that are important to the development of our business. As of December 31, 2016, we owned
approximately 12 issued or allowed U.S. patents and approximately 81 issued or allowed foreign patents related to the INTERCEPT
Blood System. Our patents expire at various dates between 2017 and 2031. Recent patent applications will, if granted, result in patents
with later expiration dates. In addition, we have a license from Fresenius to U.S. and foreign patents relating to the INTERCEPT
Blood System, which expire at various dates between 2018 and 2024. Due to the complexity of our products, we believe it is the
protection afforded to our products by the portfolio of intellectual property rights that best protect our proprietary system rather than
any one particular patent or trade secret. Proprietary rights relating to our planned and potential products will be protected from
unauthorized use by third parties only to the extent that they are covered by valid and enforceable patents or are effectively maintained
as trade secrets. The laws of certain foreign countries do not protect our intellectual property rights to the same extent as do the laws
of the U.S.
We are aware of a U.S. patent issued to a third-party that covers methods to remove psoralen compounds from blood products. We
have reviewed the patent and believe there exist substantial questions concerning its validity. We cannot be certain, however, that a
court would hold the patent to be invalid or not infringed by our platelet or plasma systems. In this regard, whether or not we infringe
this patent will not be known with certainty unless and until a court interprets the patent in the context of litigation. In the event that
we are found to infringe any valid claim of this patent, we may, among other things, be required to pay damages, cease the use and
sale of our platelet and plasma systems and/or obtain a license from the owner of the patent, which we may not be able to do at a
reasonable cost or at all. Further discussion of the factors impacting our intellectual property and the related impact on our ability to
operate our business can be found under “Item 1A—Risk Factors” of this Annual Report on Form 10-K, under the risk factor titled
“We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of
others.”
Seasonality
Our business is dependent on the marketing and commercialization of the INTERCEPT Blood System to customers such as blood
banks, hospitals, distributors and other health care providers that have a need for a pathogen reduction system to treat blood products
for transfusion. Since we have not experienced purchasing patterns from our customers based on seasonal trends, we do not expect
seasonality to have a material effect on our business, although purchasing patterns and inventory levels can fluctuate.
Inventory Requirements and Product Return Rights
Our platelet and plasma disposable kits have received regulatory approval for two-year shelf lives. Illuminators and replacement parts
do not have regulated expiration dates. We own work-in-process inventory for certain components of INTERCEPT disposable kits,
finished INTERCEPT disposable kits, illuminators, and certain replacement parts for our illuminators. Our supply chain for certain of
these components, held as work-in-process on our consolidated balance sheet, may potentially take over one year to complete
production before being utilized in finished disposable kits. We maintain inventory based on our current sales projections, and at each
reporting period, we evaluate whether our work-in-process inventory would be consumed for production of finished units in order to
sell to existing and prospective customers within the next twelve-month period. It is not customary for our production cycle for
inventory to exceed twelve months. Instead, we use our best judgment to factor in lead times for the production of our finished units to
meet our current demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for
periods exceeding one year. Inventory is recorded at the lower of cost, determined on a first in, first out basis, or market value. We use
significant judgment to analyze and determine if the composition of our inventory is obsolete, slow-moving, or unsalable and
frequently review such determinations. We rely on our direct sales team and distributors to provide accurate forecasts of sales in their
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territory. If our forecasts or those of our distributors are inaccurate, we could face backlog situations or conversely, may produce and
carry an abundance of inventory that would consume cash faster than we have currently planned. Generally, we write-down
specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use to net realizable
value in the period that it is first recognized, by using a number of factors, including product expiration dates, open and unfulfilled
orders, and sales forecasts. Any write-down of our inventory to net realizable value establishes a new cost basis and will be
maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods.
We sell the INTERCEPT Blood System directly to blood banks, hospitals, universities, and government agencies, as well as to
distributors in certain regions. Generally, our contracts with our customers do not provide for open return rights, except within a
reasonable time after receipt of goods in the case of defective or non-conforming product.
Customers and Financial Information about Geographic Areas
Our customers are concentrated and consist of blood collection organizations, some of which are nationalized, public and private
hospitals, and distributors. Distributors that purchase our products and sell to end-user customers comprise a significant amount of our
existing sales. The loss of any one of our customers would have an adverse impact on our business. The following table illustrates
concentration of sales over the past three years:
Advanced Technology Company K.S.C. ..........................................................
Etablissement Francais du Sang ........................................................................
*
Represents an amount less than 10% of product revenue.
2016
12%
*
Year Ended December 31,
2015
*
23%
2014
*
25%
To date, we have not experienced collection difficulties from these customers. For additional details about these customers for the
years ended December 31, 2016, 2015 and 2014, as well as information regarding our net revenues by geographical location and
location of our long-lived assets, see Note 17 in the Notes to Consolidated Financial Statements under “Financial Statement
Schedules—Financial Statements” of this Annual Report on Form 10-K.
Research and Development Expenses
A significant portion of our operating expenses is related to research and development and we intend to maintain a strong commitment
to our research and development efforts. We have incurred total research and development expenses of $31.3 million, $25.6 million
and $21.8 million for the years ended December 31, 2016, 2015 and 2014, respectively. As we look ahead, we anticipate that the
regulatory submission processes related to amendments to our PMA applications for the platelet system in the U.S. will require
continued investment in research and development activities, as will our ongoing clinical, development and CMC work for our red
blood cell system in Europe. In the U.S., we expect to incur increasing research and development expenses associated with clinical
trials to support our IDE in Puerto Rico and license-enabling clinical trials and activities to pursue FDA approval of our red blood cell
system. To the extent available, many of the U.S. red blood cell activities may be paid by BARDA, though no guarantee can be made
that our progress will be satisfactory to BARDA or that funds will be available to either BARDA or us. In addition, we plan to
continue spending on new product development and enhancements to our illumination device which may increase research and
development expenses. See Note 2 in the Notes to Consolidated Financial Statements under “Financial Statement Schedules—
Financial Statements” of this Annual Report on Form 10-K for costs and expenses related to research and development, and other
financial information for the years ended December 31, 2016, 2015 and 2014.
Government Regulation
We and our products are comprehensively regulated in the U.S. by the FDA and by comparable governmental authorities in other
jurisdictions.
Our European investigational plan has been based on the INTERCEPT Blood System being categorized as Class III drug/device
combination under the Medical Device Directives, or the MDD, of the European Union.
The European Union requires that medical devices affix the CE mark, an international symbol of adherence to quality assurance
standards and compliance with the MDD. We initially received the CE mark for our platelet system and separately for our plasma
system in 2002 and 2006, respectively. We will need to obtain a CE mark extension in our name from European Union regulators for
both our platelet and plasma systems every five years. The CE mark for the platelet system is effective through May 2017 while the
renewal of the approval for CE mark for the plasma system was received in September 2016. A separate CE mark certification must
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be received for the red blood cell system to be sold in the European Union and in other countries recognizing the CE mark. In
addition, France, Switzerland, Germany, and Austria require separate approvals for INTERCEPT-treated blood products.
The FDA regulates drugs, medical devices and biologics under the Federal Food, Drug, and Cosmetic Act and other laws, including,
in the case of biologics, the Public Health Service Act. These laws and implementing regulations govern, among other things, the
development, testing, manufacturing, record keeping, storage, labeling, advertising, promotion and pre-market clearance or approval
of products subject to regulation. The steps required before a medical device may be approved for marketing in the U.S. pursuant to a
PMA include:
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preclinical laboratory and animal tests;
submission to the FDA of an investigational device exemption for human clinical testing, which must become effective
before human clinical trials may begin;
appropriate tests to show the product’s safety;
adequate and well-controlled human clinical trials to establish the product’s safety and efficacy for its intended
indications;
submission to the FDA of a PMA; and
FDA review of the PMA in order to determine, among other things, whether the product is safe and effective for its
intended uses.
In December 2014, the FDA approved the platelet system for ex vivo preparation of pathogen-reduced apheresis platelet components
in order to reduce the risk of TTI, including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host
disease, or TA-GVHD. Also in December 2014, the FDA approved the plasma system for ex vivo preparation of plasma in order to
reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion. We plan to conduct development activities,
clinical studies and in vitro studies for our platelet system to expand our label claims to include, among others, storage of
INTERCEPT-treated platelets for up to seven days rather than five days, random donor platelets and a new processing set for triple
dose collections.
As a condition to the FDA approval of the platelet system, we are required to conduct a post-approval clinical study of the platelet
system. If we are unable to complete this study or the results of this study reveal unacceptable safety risks, we could be required to
perform additional studies, which may be costly, and even lose U.S. marketing approval of the platelet and/or plasma systems. In
addition to these studies, the FDA may also require us to commit to perform other lengthy post-marketing studies, for which we would
have to expend significant additional resources. In addition, there is a risk that post-approval studies will show results inconsistent
with our previous studies.
Any modifications to the platelet and plasma systems that could significantly affect their safety or effectiveness, including significant
design and manufacturing changes, or that would constitute a major change in their intended use, manufacture, design, components, or
technology requires FDA approval of a new PMA or PMA supplement. However, certain changes to a PMA-approved device do not
require submission and approval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report.
The FDA requires every supplier to make this determination in the first instance, but the FDA may review any supplier’s decision.
The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. Our products could be
subject to recall if the FDA determines, for any reason, that our products are not safe or effective or that appropriate regulatory
submissions were not made. If new regulatory approvals are required, this could delay or preclude our ability to market the modified
system. For example, due to the obsolescence of certain parts, we redesigned the illuminator used in the platelet and plasma systems.
We also understand that we will have to qualify and validate certain new plastics in the platelet and plasma systems. We will need to
seek regulatory approval of the redesigned illuminator and plastics. Should we be unable to obtain approval, our operations and
financial results will be adversely affected. In addition, in order to address the entire market in the U.S., we will need to develop and
test additional configurations of the platelet system, including making the platelet system compatible with platelets triple dose
collections and random donor platelets. Our failure to obtain FDA and foreign regulatory approvals of new platelet and plasma
product configurations could significantly limit revenues from sales of the platelet and plasma systems.
With FDA approval of our platelet and plasma systems, we are required to continue to comply with applicable FDA and other
regulatory requirements related to, among other things, labeling, packaging, storage, advertising, promotion, record-keeping and
reporting of safety and other information. In addition, our manufacturers and their facilities are required to comply with extensive
FDA and foreign regulatory agency requirements, including, in the U.S., ensuring that quality control and manufacturing procedures
conform to FDA-mandated current Good Manufacturing Practice, or cGMP, and Quality System Regulation, or QSR, requirements.
As such, we and our contract manufacturers are subject to continual review and periodic inspections. Accordingly, we and others with
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whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing,
production and quality control.
We are also required to report certain adverse events and production problems, if any, to the FDA and foreign regulatory authorities,
when applicable, and to comply with requirements concerning advertising and promotion for our products. For example, our
promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the
prohibition of the promotion of unapproved, or off-label, uses. If the FDA determines that our promotional materials or training
constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to
regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or
criminal penalties. It is also possible that other federal, state or foreign authorities might take action if they consider our promotional
or training materials to constitute promotion of an off-label use, or a violation or any other federal or state law that applies to us, such
as laws prohibiting false claims for reimbursement. Any enforcement action brought by a federal, state or foreign authority could
result in significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, exclusion from participation in
government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in
the name of the government, or refusal to allow us to enter into government contracts, contractual damages, administrative burdens,
diminished profits and future earnings, additional reporting requirements and/or oversight if we become subject to a corporate
integrity agreement or similar agreement. In addition, our reputation could be damaged and adoption of the products could be
impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or
another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, the off-label use of
our products may increase the risk of product liability claims.
CBER is the center within the FDA principally responsible for regulating the INTERCEPT Blood System. In addition to regulating
our blood safety products, CBER also regulates the blood collection centers and would regulate any blood products that they prepare
using the INTERCEPT Blood System. Prior to broader customer adoption in the U.S., U.S.-based blood centers will need to complete
their process validations and obtain site-specific licenses from CBER before making INTERCEPT-treated blood products available to
their interstate hospital customers. Additionally, the hospital customers of any of our new blood center customers will need to go
through the administrative process of generating internal tracking codes to integrate INTERCEPT-treated products into their
inventories, which may result in further delay of customer adoption in the U.S. We plan to continue working with U.S.-based blood
centers to support these activities as any delay in obtaining these licenses would adversely impact our ability to sell products in the
U.S.
We believe that in deciding whether the INTERCEPT Blood System is safe and effective regulatory authorities have taken, and are
expected to take, into account whether it adversely affects the therapeutic efficacy of blood components as compared to the therapeutic
efficacy of blood components not treated with INTERCEPT. Data from human clinical studies must demonstrate the safety of treated
blood components and their therapeutic comparability to untreated blood components. In addition, regulatory authorities will weigh
INTERCEPT’s safety, including potential toxicities of the inactivation compounds, and other risks against the benefits of using the
system in a blood supply that has become safer. We have conducted many toxicology studies designed to demonstrate the
INTERCEPT Blood System’s safety. There can be no assurance that regulatory authorities will not require further toxicology or other
studies of our products. Based on discussions with the FDA and European regulatory authorities, we believe that data only from
laboratory and animal studies, not data from human clinical studies, will be required to demonstrate the system’s efficacy in reducing
pathogens. In light of these criteria, our clinical trial programs for the INTERCEPT Blood System consist of studies that differ from
typical Phase I, Phase II and Phase III clinical studies.
The preclinical and clinical studies of the INTERCEPT Blood System for red blood cells have been conducted using prototype system
disposables and devices. In addition to the clinical trials, a number of manufacturing and validation activities must be completed
before we could sell the red blood cell product.
Further discussion of our regulatory and clinical trial status can be found in “Item 1A—Risk Factors” of this Annual Report on Form
10-K, under the risk factor titled: “Our products, blood products treated with the INTERCEPT Blood System and we are subject to
extensive regulation by domestic and foreign authorities. If our preclinical and clinical data are not considered sufficient by a
country’s regulatory authorities to grant marketing approval, we will be unable to commercialize our products and generate revenue
in that country. Our investigational red blood cell system requires extensive additional testing and development.”
Health Care Reimbursement and Reform
Our ability to commercialize our products successfully will depend in part on the extent to which appropriate reimbursement levels for
the cost of the products and related treatment are obtained. The United States Patient Protection and Affordable Care Act, or the ACA,
and ongoing cost saving efforts in the U.S. and in other regions of the world may have an impact on our ability to profitably
commercialize the INTERCEPT Blood System in the U.S. and elsewhere. For instance, the ACA and other health care reform in the
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U.S. include provisions that place downward pressure on the pricing of medical products and also introduce new taxation on medical
devices (the effective date of which has been delayed), which could further impact our profit margins.
Since its enactment, there have been judicial and Congressional challenges to numerous provisions of the ACA. In January, Congress
voted to adopt a budget resolution for fiscal year 2017, or the Budget Resolution, that authorizes the implementation of legislation that
would repeal portions of the ACA. The Budget Resolution is not a law, but it is widely viewed as the first step toward the passage of
legislation that would repeal certain aspects of the ACA. Further, on January 20, 2017, President Trump signed an Executive Order
directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the
implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare
providers, health insurers, or manufacturers of pharmaceuticals or medical devices. Congress also could consider subsequent
legislation to replace elements of the ACA that are repealed. Policy changes, including potential modification or repeal of all or parts
of the ACA or the implementation of new health care legislation could result in significant changes to the health care system.
Further discussion of the impact of health care reform and laws governing our business practices on our business can be found in
“Item 1A—Risk Factors” of this Annual Report on Form 10-K, under the risk factors titled “Legislative or regulatory healthcare
reforms may make it more difficult and costly for us to obtain regulatory approval of our products and to produce, market and
distribute our products after approval is obtained” and “We are subject to federal, state and foreign laws governing our business
practices which, if violated, could result in substantial penalties and harm our reputation and business.”
Employees
As of December 31, 2016, we had 204 employees, 62 of whom were engaged in research and development and 142 in selling, general
and administrative activities. Of the 142 employees engaged in selling, general, and administrative activities, 41 were employed by
our European subsidiary, Cerus Europe B.V. None of our employees are covered by collective bargaining agreements, and we believe
that our relationship with our employees is good.
Available Information
We maintain a website at www.cerus.com; however, information found on our website is not incorporated by reference into this report.
We make available free of charge on or through our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange
Act of 1934, as amended, or Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish
it to, the Securities Exchange Commission.
Financial Information
Our financial information including our consolidated balance sheets, consolidated statements of operations, consolidated statements of
comprehensive loss, consolidated statements of stockholders’ equity, consolidated statements of cash flows, and the related footnotes
thereto, can be found under “Financial Statement Schedules” in Part IV of this Annual Report on Form 10-K.
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Item 1A. Risk Factors
Our business faces significant risks. If any of the events or circumstances described in the following risks actually occurs, our
business may suffer, the trading price of our common stock could decline and our financial condition or results of operations could be
harmed. These risks should be read in conjunction with the other information set forth in this report. The risks and uncertainties
described below are not the only ones facing us. There may be additional risks faced by our business. Other events that we do not
currently anticipate or that we currently deem immaterial also may adversely affect our financial condition or results of operations.
We depend substantially upon the commercial success of the INTERCEPT Blood System for platelets and plasma in the United
States, or U.S., and our inability to successfully commercialize the INTERCEPT Blood System in the U.S. would have a material
adverse effect on our business, financial condition, results of operations and growth prospects.
We have invested a significant portion of our efforts and financial resources on the development of the INTERCEPT Blood System
for platelets and plasma for the U.S. market. As a result, our business is substantially dependent on our ability to successfully
commercialize the INTERCEPT Blood System in the U.S. in a timely manner. In December 2014, we received U.S. regulatory
approval of the INTERCEPT Blood System for platelets and plasma, with certain restrictions regarding usage and although the
INTERCEPT Blood System is now commercially available in the U.S., we have no prior experience commercializing any products in
the U.S. and we may be unable to commercialize the INTERCEPT Blood System in the U.S. successfully or in a timely manner, or at
all. In addition, although we received FDA approval of our platelet and plasma systems in December 2014, our commercial efforts
will be largely focused on implementing INTERCEPT to customers with whom we have previously signed agreements and
developing awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including conventional, un-
treated components. Significant revenue from customers in the U.S. may not occur, if at all, until we have been able to successfully
implement the platelet and plasma systems and demonstrate that they are economical, safe and efficacious for potential customers.
Based on our experience in foreign jurisdictions, current and potential customers in the U.S. may first choose to validate our
technology or conduct experience studies of the INTERCEPT Blood System, among other activities, prior to purchasing or deciding
whether to adopt the INTERCEPT Blood System for commercial use, which may never occur. In addition, potential customers and
certain existing customers must obtain site-specific licenses from the Center for Biologics Evaluation and Research, or CBER, prior to
engaging in interstate transport of blood components processed using the INTERCEPT Blood System, which could significantly delay
or preclude our ability to successfully commercialize the INTERCEPT Blood System to those customers for the portion of their
business involved in interstate commerce. Until those licenses are obtained, U.S. blood centers will be limited to sales to hospital
customers within the state in which the INTERCEPT-treated platelets or plasma are processed. Further, the hospital customers of any
of our new blood center customers will need to go through the administrative process of generating internal tracking codes to integrate
INTERCEPT-treated products into their inventories, which may further delay customer adoption in the U.S. The availability of
platelets in the U.S. is currently constrained. Should U.S. blood centers prioritize obtaining and selling conventional, untreated platelet
components over INTERCEPT-treated components, we may not achieve widespread market adoption. If we are not successful in
achieving market adoption of the INTERCEPT Blood System in the U.S., we may never generate substantial revenue, and our
business, financial condition, results of operations and growth prospects would be materially and adversely affected.
Our ability to successfully commercialize the INTERCEPT Blood System for platelets and plasma in the U.S. will depend on our
ability to:
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achieve market acceptance and generate product sales through execution of sales agreements on commercially reasonable
terms;
enter into and maintain sufficient manufacturing arrangements for the U.S. market with our third party suppliers;
create market demand for the INTERCEPT Blood System through our education, marketing and sales activities;
hire, train, deploy, support and maintain a qualified U.S.-based commercial organization and field sales force;
expand the labeled indications of use for the INTERCEPT Blood System and/or design, develop and test new product
configurations;
comply with requirements established by the FDA, including post-marketing requirements and label restrictions; and
comply with other U.S. healthcare regulatory requirements.
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In addition to the other risks described herein, our ability to successfully commercialize the INTERCEPT Blood System for platelets
and plasma in the U.S. is subject to a number of risks and uncertainties, including those related to:
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the highly concentrated U.S. blood collection market that is dominated by a small number of blood collection
organizations;
regulatory and licensing requirements, including the CBER licensing process that U.S.-based blood centers are required to
follow in order to obtain the required site-specific licenses to engage in interstate transport of blood components processed
using the INTERCEPT Blood System;
changed or increased regulatory restrictions or requirements;
the amount available for reimbursement pursuant to codes we have obtained under the Healthcare Common Procure
Coding System, or HCPCS, and pricing for outpatient use of INTERCEPT-treated blood components;
any supply or manufacturing problems or delays arising with any of our suppliers, many of whom are our sole suppliers
for the particular product or component they manufacture, including the ability of such suppliers to maintain FDA
approval to manufacture the INTERCEPT Blood System and to comply with FDA-mandated current Good Manufacturing
Practice, or cGMP, and Quality System Regulation, or QSR, requirements;
changes in healthcare laws and policy, including changes in requirements for blood product coverage by U.S. federal
healthcare programs; and
acceptance of the INTERCEPT Blood System as safe, effective and economical from the broad constituencies involved in
the healthcare system.
In addition to the above, our ability to successfully commercialize the INTERCEPT Blood System in the U.S. is dependent on our
ability to operate without infringing on the intellectual property rights of others. For example, we are aware of a U.S. patent issued to a
third-party that covers methods to remove psoralen compounds from blood products. We have reviewed the patent and believe there
exists substantial questions concerning its validity. We cannot be certain, however, that a court would hold the patent to be invalid or
not infringed by our platelet or plasma systems. In this regard, whether or not we infringe this patent will not be known with certainty
unless and until a court interprets the patent in the context of litigation. In the event that we are found to infringe any valid claim of
this patent, we may, among other things, be required to pay damages, cease the use and sale of our platelet and plasma systems and/or
obtain a license from the owner of the patent, which we may not be able to do at a reasonable cost or at all.
These and the other risks described below related to the commercialization of the INTERCEPT Blood System could have a material
adverse effect on our ability to successfully commercialize the INTERCEPT Blood System for platelets and plasma in the U.S.
The INTERCEPT Blood System may not achieve broad market adoption.
In order to increase market adoption of the INTERCEPT Blood System and to create market demand in the U.S., we must address
issues and concerns from broad constituencies involved in the healthcare system, from blood centers to patients, transfusing
physicians, key opinion leaders, hospitals, private and public sector payors, regulatory bodies and public health authorities. We may
be unable to demonstrate to these constituencies that the INTERCEPT Blood System is safe, effective and economical or that the
benefits of using the INTERCEPT Blood System products justify their cost and outweigh their risks.
The use of the platelet system results in some processing loss of platelets. If the loss of platelets leads to increased costs, or the
perception of increased costs, for our customers, our customers or prospective customers believe that the loss of platelets reduces the
efficacy of the transfusion unit, or our process requires changes in blood center or clinical regimens, prospective customers may not
adopt our platelet system. Certain customers that attempt to optimize collection practices in order to produce the highest volume of
transfusable units with those collections may experience a less optimized yield as result of adopting INTERCEPT over conventional
platelet products. Certain studies have indicated that transfusion of conventionally prepared platelets may yield higher post-transfusion
platelet counts (according to a measurement called “corrected count increment”) and may be more effective than transfusion of
INTERCEPT-treated platelets. Although certain other studies demonstrate that INTERCEPT-treated platelets retain therapeutic
function comparable to conventional platelets, prospective customers may choose not to adopt our platelet system due to
considerations relating to corrected count increment, efficacy or other factors.
The INTERCEPT Blood System does not inactivate all known pathogens, and the inability of the INTERCEPT Blood System to
inactivate certain pathogens may limit its market adoption. For example, our products have not been demonstrated to be effective in
the reduction of certain non-lipid-enveloped viruses, including hepatitis A and E viruses, due to these viruses’ biology. In addition, our
products have not demonstrated a high level of reduction for human parvovirus B-19, which is also a non-lipid-enveloped virus.
Although we have shown high levels of reduction of a broad spectrum of lipid-enveloped viruses, prospective customers may choose
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not to adopt our products based on considerations concerning inability to inactivate, or limited reduction, of certain non-lipid-
enveloped viruses. Similarly, although our products have been demonstrated to effectively inactivate spore-forming bacteria, our
products have not been shown to be effective in reducing bacterial spores once formed. In addition, our products do not inactivate
prions since prions do not contain nucleic acid. While transmission of prions has not been a major problem in blood transfusions, and
we are not aware of any competing products that inactivate prions, the inability to inactivate prions may limit market adoption of our
products. Furthermore, due to limitations of detective tests, we cannot exclude that a sufficient quantity of pathogen or pathogens may
still be present in active form, which could present a risk of infection to the transfused patient. Should INTERCEPT-treated
components contain detectable levels of pathogens after treatment, the efficacy of INTERCEPT may be called into question, whether
or not any remaining pathogens are the result of INTERCEPT’s efficacy or other factors. Such uncertainties may limit the market
adoption of our products.
In 2015, we conducted a Phase I clinical study protocol under an investigational device exemption, or IDE, to treat plasma derived
from convalesced patients that were previously infected with the Ebola virus and had recovered from the disease according to the
criteria set by the Centers for Disease Control and Prevention. The transfusion of convalesced plasma from Ebola survivors is believed
to pass on antibodies to the disease from the survivor to the recipient of the plasma transfusion. INTERCEPT use under the IDE was
limited to pathogen reduction claims that relied on existing clinical data that we had regarding reduction of certain pathogens in
donated plasma. Following the conclusion of this study, we did not have any clinical or commercial data on the efficacy of
INTERCEPT to inactivate the Ebola virus and therefore do not know the effectiveness of INTERCEPT to inactivate the Ebola virus.
This may negatively impact a customer’s desire to adopt INTERCEPT in those countries where addressing an Ebola virus outbreak is
a primary concern.
We have conducted studies of our products in both in vitro and in vivo environments using well-established tests that are accepted by
regulatory bodies. When an in vitro test was not generally available or not well-established, we conducted in vivo studies in
mammalian models to predict human responses. Although we have no reason to believe that the in vitro and in vivo studies are not
predictive of actual results in humans, we cannot be certain that the results of these in vitro and in vivo studies accurately predict the
actual results in humans in all cases. In addition, strains of infectious agents in living donors may be different from those strains
commercially available or for which we have tested and for which we have received approval of the inactivation claims for our
products. To the extent that actual results in human patients differ, commercially available or tested strains prove to be different, or
customers or potential customers perceive that actual results differ, from the results of our in vitro or in vivo testing, market
acceptance of our products may be negatively impacted.
If customers experience operational or technical problems with the use of INTERCEPT Blood System products, market acceptance
may be reduced or delayed. For example, if adverse events arise from incomplete reduction of pathogens, improper processing or user
error, or if testing of INTERCEPT-treated blood samples fails to reliably confirm pathogen reduction, whether or not directly
attributable to the INTERCEPT Blood System, customers may refrain from purchasing our products. Furthermore, should customers
communicate operational problems or suspected product failure, we will need to investigate and report imputability to the relevant
regulatory authorities in a timely manner. We may be required to file reports on such complaints or product failure before we have the
ability to obtain conclusive data as to imputability which may cause concern with existing and prospective customers or regulators. In
addition, there is a risk that further studies that we or others may conduct, including the post-approval studies we are required to
conduct as a condition to the FDA approval of the platelet system, will show results inconsistent with previous studies. Should this
happen, potential customers may delay or choose not to adopt our products and existing customers may cease use of our products. In
addition, some hospitals may decide to purchase and transfuse both INTERCEPT-treated blood components and conventional blood
components. Managing such a dual inventory of blood products may be challenging, and hospitals may need to amend their product
labels and inventory management systems before being able to move forward with INTERCEPT. This may require coordination
between hospital suppliers and blood centers, which in turn may cause delay in market adoption. Further, in certain markets, potential
customers may require us to develop, sell, and support data management application software for their operations before they would
consider adopting INTERCEPT. Such software development efforts may be costly or we may be unsuccessful in developing a data
management application that would be broadly accepted. Developing, maintaining and supporting software can be time consuming,
costly and may require resources and skill sets that we do not possess. Failure to do so may limit market adoption in geographies
where we commercialize the INTERCEPT Blood System, including the U.S.
Market adoption of our products is affected by blood center and healthcare facility budgets and the availability of reimbursement from
governments, managed care payors, such as insurance companies, and/or other third parties. In many jurisdictions, due to the structure
of the blood products industry, we have little control over budget and reimbursement discussions, which generally occur between
blood centers, healthcare facilities such as hospitals, and national or regional ministries of health and private payors. Even if a
particular blood center is prepared to adopt the INTERCEPT Blood System, its hospital customers may not accept or may not have the
budget to purchase INTERCEPT-treated blood products. Since blood centers would likely not eliminate the practice of screening
donors or testing blood for some pathogens prior to transfusion, even after implementing our products, some blood centers may not be
able to identify enough cost offsets or hospital pricing increases to afford to purchase our products. Budgetary concerns may be further
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exacerbated by economic legislation in certain countries and by proposals by legislators at both the U.S. federal and state levels,
regulators, healthcare facilities and third party payors to keep healthcare costs down, which may limit the adoption of new
technologies, including our products. In some jurisdictions, including in the U.S. for in-patient treatment, commercial use of our
products is not approved for reimbursement by governmental or commercial third party payors for health care services and may never
be approved for specific reimbursement. In the U.S., we only recently obtained HCPCS reimbursement codes for INTERCEPT treated
platelets and plasma in the outpatient setting in 2015. The costs and expenses incurred by the blood center related to donor blood are
typically included in the price that the blood center charges a hospital for a unit of blood. Even after blood components treated with
our products are approved for reimbursement by governmental or commercial third party payors, including under the new HCPCS
codes, the costs and expenses related to use of the INTERCEPT Blood System will not be directly reimbursed, but instead may be
incorporated within the reimbursement structure for medical procedures and/or products at the site of patient care. If the costs to the
hospital for INTERCEPT-processed blood products cannot be easily, readily, or fully incorporated into the existing reimbursement
structure, hospital billing and/or reimbursement for these products could be impacted, thus negatively impacting hospitals’ acceptance
and uptake of our products.
The market for the INTERCEPT Blood System is highly concentrated with few customers, including often-dominant regional or
national blood collection entities. Even where our products receive regulatory approval and reimbursement is available, failure to
effectively market, promote, distribute, price or sell our products to any of these customers could significantly delay or even diminish
potential product revenue in those geographies. Moreover, the market for pathogen reduction systems in the U.S. is highly
concentrated and dominated by a small number of blood collection organizations. In the U.S., the American Red Cross represents the
largest single portion of the blood collection market. While we entered into a multi-year commercial agreement with the American
Red Cross in February 2016, we cannot guarantee the volume or timing of commercial purchases that the American Red Cross may
make, if any, under our agreement. Our ability to gain significant market penetration in the U.S. is largely dependent on utilization of
INTERCEPT and distribution of INTERCEPT treated blood components by the American Red Cross. The American Red Cross is a
large organization and broad-based utilization of INTERCEPT and distribution of INTERCEPT treated products may be concentrated
in a limited number of centers or may occur slowly, if at all. Conversely, given the large relative size of the American Red Cross,
should they deploy the technology rapidly, our resources may be inadequate to fulfill the American Red Cross’s and other customers’
demands, which could result in a loss of revenues or customer contracts, or both. In many countries in Western Europe and in Japan,
various national blood transfusion services or Red Cross organizations collect, store and distribute virtually all of their respective
nations’ blood and blood components supply. In Europe, the largest markets for our products are in Germany, France, and England. In
Germany, decisions on product adoption and subsequent reimbursement are made on a regional or even blood center-by-blood center
basis, but depend on both local approvals and centralized regulatory approvals from the Paul Ehrlich Institute, or PEI. Product
specifications that receive marketing authorization from the PEI may differ from product specifications that have been adopted in
other territories where we rely on CE mark approval, thereby necessitating market specific modifications to the commercial product,
which may not be economical or technically feasible for us. While INTERCEPT-treated platelets and plasma have received in-country
regulatory approval and reimbursement rates have been established in France, adoption throughout France has been limited to certain
blood centers.
In December 2015, we entered into a new two-year framework agreement with the Établissement Français du Sang, or the EFS, to
supply platelet and plasma disposable kits. In March 2016, we entered into a subsequent contract with EFS for a period of one year at
certain defined prices. We cannot provide any assurance that the terms, including the pricing or committed volumes, if any, of any
additional subsequent contract will be equivalent or superior to the terms under our current subsequent contract. If the final
commercial terms of any subsequent contract are less favorable than the terms under our existing contract, our financial results may be
adversely impacted.
In Japan, the Japanese Red Cross controls a significant majority of blood transfusions and exerts a high degree of influence on the
adoption and use of blood safety measures in Japan. The Japanese Red Cross has been reviewing preclinical and clinical data on
pathogen reduction of blood over a number of years and has yet to make a formal determination to adopt any pathogen reduction
approach. We also understand that the Japanese Red Cross has begun formal evaluation of a competing technology. Before the
Japanese Red Cross considers our products, we understand that we may need to commit to making certain product configuration
changes, which are currently under development but may not be economically or technologically feasible for us to accomplish.
We expect to continue to generate losses.
We may never achieve a profitable level of operations. Our cost of product sold, research and development and selling, general and
administrative expenses have resulted in substantial losses since our inception. The platelet and plasma systems have been approved in
the U.S. only since December 2014 and are not approved in many countries around the world. The red blood cell system is in the
development stage and may never emerge from the development stage as a marketed product. We may be required to reduce the sales
price for our products in order to make our products economically attractive to our customers and to governmental and private payors,
or to compete favorably with other blood safety interventions or other pathogen reduction technologies, which may reduce or
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altogether eliminate our gross profit on sales. At our present and expected near-term sales levels of the platelet and plasma systems,
our costs to manufacture, distribute, market, sell, and support the systems are and are expected to continue to be in excess of our
revenue. We expect our losses to continue at least until we are able to gain widespread commercial adoption, which may never occur.
In addition to increased selling, general and administrative expenses in connection with the continuing U.S. commercial launch of our
platelet and plasma systems, we expect to incur additional research and development costs associated with the development of
different configurations of existing products including our illuminator, development of new products, planning, enrolling and
completing ongoing clinical and non-clinical studies, including the post-approval studies we are required to conduct in connection
with the FDA approval of the platelet system, pursuing potential regulatory approvals in other geographies where we do not currently
sell our platelet and plasma systems, planning and conducting in vitro studies and clinical development of our red blood cell system in
Europe and the U.S., and completing activities to support a potential CE mark submission for our red blood cell system in Europe.
These costs could be substantial and could extend the period during which we expect to operate at a loss, particularly if we experience
any difficulties or delays in completing the activities.
In certain countries, governments have issued regulations relating to the pricing and profitability of medical products and medical
product companies. Healthcare reform in the U.S. has also placed downward pressure on the pricing of medical products that could
have a negative impact on our profit margins.
Adverse market and economic conditions may exacerbate certain risks affecting our business.
Sales of our products are dependent on purchasing decisions of and/or reimbursement from government health administration
authorities, distribution partners and other organizations. As a result of adverse conditions affecting the global economy and credit and
financial markets, disruptions due to political instability or terrorist attacks, economies and currencies largely affected by declining
commodity prices or otherwise, these organizations may defer purchases, may be unable to satisfy their purchasing or reimbursement
obligations, or may delay payment for the INTERCEPT Blood System. In addition, there have been concerns for the overall stability
and suitability of the Euro as a single currency given the economic and political challenges facing individual Eurozone countries.
Continuing deterioration in the creditworthiness of Eurozone countries, the withdrawal of, or the announcement of the withdrawal of,
one or more member countries from the European Union, or E.U., following the United Kingdom’s, or U.K.’s, referendum in which
voters approved an exit from the E.U., or the failure of the Euro as a common European currency or an otherwise diminished value of
the Euro could materially and adversely affect our product revenue.
Additionally, a meaningful amount of our revenue has come from sales to our distributor in Russia and other CIS countries. Low
worldwide oil prices and the ongoing civil, political and economic disturbances in Russia, Turkey and Ukraine, and their spillover
effect on surrounding areas, along with the impact of sanctions imposed against Russia by certain European nations and the U.S., have
significantly devalued the Russian Ruble and other CIS currencies and may continue to have a negative impact on the Russian and
other CIS countries’ economies, particularly if sanctions continue to be levied against Russia or are strengthened from those currently
in place from either the E.U., U.S. or both. While our agreement with our Russian and other CIS distributors calls for sales, invoicing
and collections to be denominated in Euros, if significant sanctions continue or are strengthened, if new sanctions are imposed in
connection with Russia’s alleged interference in the U.S. election or otherwise, if worldwide oil prices continue to remain low and/or
if measures taken by the Russian government to support the Ruble fail, the Russian economy and value of the Ruble or other CIS
currencies may further weaken or remain weak, and our business in Russia and other CIS countries may be negatively impacted
further. Similarly, low worldwide oil prices and current political conflicts may negatively impact potential future sales of our products
in the Middle East and other oil producing exporters.
In addition, terrorist attacks and civil unrests in some of the countries where we do business, and the resulting need for enhanced
security measures may impact our ability to deliver services, threaten the safety of our employees, and increase our costs of
operations.
Our products, blood products treated with the INTERCEPT Blood System and we are subject to extensive regulation by domestic
and foreign authorities. If our preclinical and clinical data are not considered sufficient by a country’s regulatory authorities to
grant marketing approval, we will be unable to commercialize our products and generate revenue in that country. Our
investigational red blood cell system requires extensive additional testing and development.
Our products, both those sold commercially and those under development are subject to extensive and rigorous regulation by local,
state and federal regulatory authorities in the U.S. and by foreign regulatory bodies. These regulations are wide-ranging and govern,
among other things:
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development;
testing;
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manufacturing;
labeling;
storage;
clinical trials;
product safety;
pre-market clearance or approval;
sales and distribution;
use standards and documentation;
conformity assessment procedures;
product traceability and record keeping procedures;
post-launch surveillance and post-approval studies;
quality;
advertising and promotion;
product import and export; and
reimbursement.
Our products must satisfy rigorous standards of safety and efficacy and we must adhere to quality standards regarding manufacturing
and customer-facing business processes in order for the FDA and international regulatory authorities to approve them for commercial
use. For our product candidates, we must provide the FDA and international regulatory authorities with preclinical, clinical and
manufacturing data demonstrating that our products are safe, effective and in compliance with government regulations before the
products can be approved for commercial sale. The process of obtaining required regulatory approvals is expensive, uncertain and
typically takes a number of years. We may continue to encounter significant delays or excessive costs in our efforts to secure
necessary approvals or licenses, or we may not be successful at all. In addition, our labeling claims may not be consistent across
markets. Our approved labels from the FDA limit our current approvals to certain platelet collection platforms and a particular storage
solution for the particular collection platform. For instance, our FDA approved claims permit apheresis collection of platelets on the
Fresenius-Kabi Amicus device while stored in an additive solution or for apheresis collection of platelets collected on the Terumo
Trima device and stored in 100% plasma. Such discrepant collection methodologies and storage solutions and conditions also exist for
red blood cells. We may be required to provide the FDA with data for each permutation for which blood banking treatment practices
exist which may be time consuming, costly and limit the potential size of the U.S. market that can use our products. In addition, in
order to generate data that would be satisfactory to the FDA, we need to test our products with different blood center production
configurations producing otherwise saleable products for the blood center. As such, we will generally need to purchase blood
components which are expensive and may be limited during periods of low availability. For example, we are currently experiencing
such availability constraints for platelets. Any such inability to procure blood components at a reasonable price, or at all, to conduct
studies in order to generate data sufficient for label claim expansions may negatively impact our business opportunities.
Clinical and Preclinical
Clinical trials are particularly expensive and have a high risk of failure. Any of our trials may fail or may not achieve results sufficient
to attain market acceptance, which could prevent us from achieving profitability. We do not know whether we will begin or complete
clinical trials on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory
approval to commence a study, delays in reaching agreement on acceptable clinical study agreement terms with prospective clinical
sites, delays in obtaining institutional review board, ministry of health or ethical committee approval to conduct a study at a
prospective clinical site, delays in recruiting subjects to participate in a study, delays in the conduct of the clinical trial by personnel at
the clinical site or due to our inability to actively and timely monitor clinical trial sites because of travel restrictions, political
instability or terrorist activity or concerns over employee safety. For example, our chronic anemia trial is currently ongoing in Turkey.
We have in the past restricted and may again in the future need to restrict travel to Turkey for monitoring site visits or to otherwise
manage the trial due to state department issued travel warnings and restrictions. Significant delays in clinical testing could also
materially impact our clinical trials. Criteria for regulatory approval in blood safety indications are evolving, reflecting competitive
advances in the standard of care against which new product candidates are judged, as well as changing market needs and
reimbursement levels. Clinical trial design, including enrollment criteria, endpoints and anticipated label claims are thus subject to
change, even if original objectives are being met. As a result, we do not know whether any clinical trial will result in marketable
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products. Typically, there is a high rate of failure for product candidates in preclinical studies and clinical trials and products emerging
from any successful trial may not reach the market for several years.
Enrollment criteria for certain of our clinical trials may be quite narrow, further delaying the clinical trial process. For instance,
clinical trials previously conducted using INTERCEPT-treated plasma for patients with thrombotic thrombocytopenic purpura lasted
approximately four years due in part to the difficulties associated with enrolling qualified patients. In addition, enrollment criteria have
impacted the speed with which we were able to enroll patients in our ongoing Phase III red blood cell system trial in chronic anemia in
Europe. Consequently, we may be unable to recruit suitable patients into clinical trials on a timely basis, if at all, which may lead to
higher costs or the inability to complete the clinical trials. We cannot rely on interim results of trials to predict their final results, and
acceptable results in early trials might not be repeated in later trials. Any trial may fail to produce results satisfactory to the FDA or
foreign regulatory authorities. In addition, preclinical and clinical data can be interpreted in different ways, which could delay, limit or
prevent regulatory approval. Negative or inconclusive results from a preclinical study or clinical trial, or adverse medical events
during a clinical trial could cause a preclinical study or clinical trial to be repeated, require other studies to be performed or cause a
program to be terminated, even if other studies or trials relating to a program are successful.
We have conducted many toxicology studies to demonstrate the safety of the platelet and plasma systems, and we have conducted and
plan to conduct toxicology studies for the red blood cell system throughout the product development process. At any time, the FDA
and other regulatory authorities may require further toxicology or other studies to further demonstrate our products’ safety, which
could delay or preclude regulatory approval and commercialization. In addition, the FDA or foreign regulatory authorities may alter
guidance at any time as to what constitutes acceptable clinical trial endpoints or trial design, which may necessitate a redesign of our
product or proposed clinical trials and cause us to incur substantial additional expense or time in attempting to gain regulatory
approval. Regulatory agencies weigh the potential risks of using our pathogen reduction products against the incremental benefits,
which may be difficult or impossible to quantify.
If any additional product candidates receive approval for commercial sale in the U.S., or if we obtain approval for expanded label
claims for the platelet system or plasma system, the FDA may require one or more post-approval clinical or in vitro studies as a
condition of approval, such as the post-approval clinical study we are required to conduct in connection with the approval of the
platelet system and the additional post-approval study that we are required to conduct on recovery and survival of platelets suspended
in 100% plasma in connection with the recent expanded label claim that we received for the platelet system. Each of these studies and
any additional studies that the FDA may require could involve significant expense and may require us to secure adequate funding to
complete. In addition, enrollment of post-marketing studies may be difficult to complete timely if blood center customers are
unwilling to use conventional, un-treated products once INTERCEPT products are available. Other regulatory authorities outside of
the U.S. may also require post-marketing studies. Governments or regulatory authorities may impose new regulations or other changes
or we may discover that we are subject to additional regulations that could further delay or preclude regulatory approval and
subsequent adoption of our potential products. We cannot predict the adoption, implementation or impact of adverse governmental
regulation that might arise from future legislative or administrative action. Furthermore, any guidance document or mandate that
prescribes use of INTERCEPT may impose a compliance requirement on blood centers that operate and process blood components in
a manner for which we do not yet have approved label claims. Our inability to meet such operational constraints may impair our
potential results permanently or until we are able to obtain such claims.
Outside the U.S., regulations vary by country, including the requirements for regulatory and marketing approvals or clearance, the
time required for regulatory review and the sanctions imposed for violations. In addition to CE mark documentation, countries outside
the E.U. may require clinical data submissions, registration packages, import licenses or other documentation. Regulatory authorities
in Japan, China, Taiwan, South Korea, Vietnam, Thailand, Singapore and elsewhere may require in-country clinical trial data, among
other requirements, or that our products be widely adopted commercially in Europe and the U.S., or may delay approval decisions
until our products are more widely adopted. In addition to the regulatory requirements applicable to us and to our products, there are
regulatory requirements in several countries around the world, including the U.S., Germany, Canada, Austria, Australia and other
countries, applicable to prospective customers of INTERCEPT Blood System products, the blood centers that process and distribute
blood and blood products. In those countries, blood centers and other customers are required to obtain approved license supplements
from the appropriate regulatory authorities before making available blood products processed with our pathogen reduction systems to
hospitals and transfusing physicians. Our customers may lack the resources or capability to obtain such regulatory approvals. For
example, in the U.S., blood centers are required to obtain site-specific licenses from CBER prior to engaging in interstate transport of
blood components processed using the INTERCEPT Blood System. These requirements or regulators’ delays in approving license
applications or supplements may deter some blood centers from using our products. Blood centers that do submit applications or
supplements for manufacturing and sale may face disapproval or delays in approval that could further delay or deter them from using
our products. The regulatory impact on potential customers could slow or limit the potential sales of our products.
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Red Blood Cell System
Our red blood cell system is currently in development and has not been commercialized anywhere in the world. Significant
development and financial resources will be required to progress the red blood cell system into a commercially viable product and to
obtain the necessary regulatory approvals for the product. Final development of the red blood cell system may never occur and failure
can occur any time during the process. Any failure or delay in completing the development activities for the red blood cell system
would prevent or delay its commercialization, which could materially and adversely affect our business, financial condition, results of
operations, growth prospects and potential future market adoption of any of our products, including the red blood cell system. Many of
the factors described above that can contribute to the failure or delay of a clinical trial could impact the trials we conduct for our red
blood cell system. Even if we are successful in earlier clinical trials, the results of those early trials may not be predictive of results
obtained in later and larger clinical trials of the red blood cell system or the results of routine use if we are able to commercialize the
red blood cell system. In those cases, the FDA or foreign regulatory agencies may require we engage in additional clinical trials or
conduct further studies or analysis which may be costly and time-consuming. Furthermore, regulators may require clinical data for our
red blood cell system under each collection and processing method using various additive or storage solutions before they would grant
approval for any such configuration. If we were unable to collect data under each configuration or if we elect to pursue certain
configurations over others for initial approval, our market opportunity may be limited. In some instances, we are relying on contract
research organizations and other third parties to assist us in designing, managing, monitoring and otherwise carrying out our clinical
trials and development activities for the red blood cell system. We do not control these third parties and, as a result, they may not treat
our activities as their highest priority, or in the manner in which we would prefer, which could result in delays, inefficient use of our
resources and could distract personnel from other activities. Additionally, if we, our contract research organizations or other third
parties assisting us or our study sites fail to comply with applicable good clinical practices, the clinical data generated in our trials may
be deemed unreliable and the FDA or foreign regulatory agencies may require us to perform additional clinical trials before approving
the red blood cell system for commercialization. We cannot assure you that, upon inspection, regulatory agencies will determine that
any of our clinical trials comply with good clinical practices. In addition, our clinical trials must be conducted with product produced
under the FDA’s cGMP regulations and similar regulations outside of the U.S. Our failure or the failure of our product manufacturers
to comply with these regulations may require us to repeat or redesign clinical trials, which would delay the regulatory approval
process.
In 2003, we terminated Phase III clinical trials evaluating a prior generation of the red blood cell system in acute and chronic anemia
patients. The trials were terminated due to the detection of antibody reactivity to INTERCEPT-treated red blood cells in two patients
in the 2003 chronic anemia trial. Although the antibody reactivity was not associated with any adverse events, we developed process
changes designed to diminish the likelihood of antibody reactivity in red blood cells treated with our modified process. In a
subsequent Phase I clinical trial that we initiated in the fourth quarter of 2008 to evaluate recovery and survival of treated red blood
cells with the modified process, there were no adverse events reported. Based on the results from that trial, we obtained approval for
and commenced two Phase III clinical trials in Europe using the modified process in patients with acute and chronic anemia,
respectively. We successfully completed the acute anemia Phase III clinical trial, with the INTERCEPT Blood System for red blood
cells meeting its primary endpoint. However, we cannot assure you that the adverse events observed in the terminated 2003 Phase III
clinical trials of our earlier red blood cell system will not be observed in the ongoing chronic anemia Phase III or any future clinical
trials of our red blood cell system. In addition, although our recently-completed Phase III clinical trial in acute anemia patients using
our modified process met its primary endpoint, we cannot assure you that the same or similar results will be observed in our ongoing
Phase III chronic anemia or any potential future clinical trials using our modified process.
We will need to successfully conduct and complete a license-enabling Phase III clinical trial in the U.S. before the FDA will consider
our red blood cell product for approval. The FDA will require us to successfully complete and submit one or more additional in vitro
studies prior to any initiation of a potential Phase III clinical trial. There can be no assurance that we will be able to successfully
satisfy any such in vitro studies, nor can there be any assurance that we and the FDA will agree to any trial protocol we propose or that
we will otherwise obtain FDA clearance to initiate a potential Phase III clinical trial. The FDA will require us to place a clinical hold
on any clinical trial if we see a hemolytic reaction associated with treatment with emergent antibodies with amustaline specificity in
patients receiving INTERCEPT-treated red blood cells in that trial. Should we experience such an incident, we will need to investigate
the underlying cause of the hemolytic reaction, which in many patient populations may be difficult for us to assess imputability which
may lead to a complete halt of the clinical trial, may irreparably harm our red blood cell product’s reputation and we may be forced to
suspend or terminate development activities related to the red blood cell system in the U.S., which would have a material adverse
effect on our business and business prospects. In addition, if we are unable to reach agreement with the FDA on a license-enabling
Phase III clinical trial design for our red blood cell system, our agreement with BARDA will be severely limited in scope or could be
terminated altogether.
We completed our European Phase III clinical trial of our red blood cell system for acute anemia patients and have another European
Phase III clinical trial of our red blood cell system for chronic anemia patients ongoing. Although we plan to complete development
activities to support an anticipated CE mark submission, such activities, including any additional studies required by the FDA prior to
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its review of any proposed U.S. Phase III clinical trial protocol, could prolong development of the red blood cell system, and we
cannot predict when we would receive regulatory approval of our red blood cell system, if ever. We understand that while the acute
anemia Phase III clinical trial in Europe may be sufficient to receive CE mark approval in the E.U., we may need to generate
additional safety data from commercial use and/or achieve a successful outcome in the ongoing chronic anemia Phase III clinical trial
for our red blood cell system in order to achieve broad market acceptance. Failure to successfully complete such clinical trials and
generate a body of data in chronic patients in a clinical or commercial setting may delay regulatory approval, commercialization or
market adoption. In addition, the trials may need to be supplemented by additional, successful Phase III clinical trials for approval in
certain countries. If such additional Phase III clinical trials are required, they would likely need to demonstrate equivalency of
INTERCEPT-treated red blood cells compared to conventional red blood cells and the significantly lower lifespan for INTERCEPT-
treated red blood cells compared to non-treated red blood cells may limit our ability to obtain regulatory approval for the product. A
number of trial design issues that could impact efficacy, regulatory approval and market acceptance will need to be resolved prior to
the initiation of further clinical trials. In addition, if we are unable to secure the full amount of funding contemplated by the BARDA
agreement for any reason, our ability to complete the development activities required for potential licensure in the U.S. may require
additional capital beyond which we currently have, and we may be required to obtain additional capital in order to complete the
development of and obtain any regulatory approvals for the red blood cell system. If alternative sources of funding are not available,
we may be forced to suspend or terminate development activities related to the red blood cell system in the U.S. which would have a
material adverse effect on our business and business prospects. If we are unsuccessful in advancing the red blood cell system through
clinical trials, resolving process and product design issues or in obtaining subsequent regulatory approvals and acceptable
reimbursement rates, we may never realize a return on our R&D expenses incurred to date for the red blood cell system program.
Regulatory delays can also materially impact our product development costs. If we experience delays in testing, conducting trials or
approvals, our product development costs will increase, which costs may not be reimbursable to us under the BARDA agreement.
Even if we were to successfully complete and receive approval for our red blood cell system, potential blood center customers may
object to working with a potent chemical, like amustaline, the active compound in the red blood cell system, or may require
modifications to automate the process, which would result in additional development costs, any of which could limit any market
acceptance of the red blood cell system. If the red blood cell system were to face such objections from potential customers, we may
choose to pay for capital assets, specialized equipment or personnel for the blood center, which would have a negative impact on any
potential contribution margin from red blood cell system sales.
Platelet and Plasma Systems
In 2007, we obtained a CE mark approval (extended in 2012) from E.U. regulators for our platelet system and will need to obtain an
extension every five years. We or our customers have received approval for the sale and/or use of INTERCEPT-treated platelets
within the Europe in France, Switzerland, Germany and Austria. We or our customers may also be required to conduct additional
testing in order to obtain regulatory approval in countries that do not recognize the CE mark as being adequate for commercializing
the INTERCEPT Blood System in those countries. The level of additional product testing varies by country, but could be expensive or
take a long time to complete. In addition, regulatory agencies are able to withdraw or suspend previously issued approvals due to
changes in regulatory law, our inability to maintain compliance with regulations or other factors.
In 2006, we obtained a CE mark approval (extended in 2011) from E.U. regulators for our plasma system and in September 2016
received the renewal of the approval in accordance with the five year renewal schedule. We or our customers have received approval
for the sale and/or use INTERCEPT-treated plasma within Europe in France, Switzerland, Austria and Germany. In some countries,
including several in Europe, we or our customers may be required to perform additional clinical studies or submit manufacturing and
marketing applications in order to obtain regulatory approval. If we or our customers are unable to obtain or maintain regulatory
approvals for the use and sale or continued sale and use of INTERCEPT-treated platelets or plasma, market adoption of our products
will be negatively affected and our growth prospects would be materially and adversely impacted.
In December 2014, the FDA approved the platelet system for ex vivo preparation of pathogen-reduced apheresis platelet components
in order to reduce the risk of transfusion-transmitted infection, or TTI, including sepsis, and to potentially reduce the risk of
transfusion-associated graft versus host disease, or TA-GVHD. Also in December 2014, the FDA approved the plasma system for ex
vivo preparation of plasma in order to reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion. We have
conducted and are conducting additional in vitro studies for our platelet system to potentially expand our label claims to include,
among others, platelets collected from pooled random donors, storage of INTERCEPT-treated platelets for up to seven days rather
than five days, and a new processing set for triple dose collections. Failure to obtain any of these label expansion claims may
negatively affect market adoption and our growth prospects would be materially and adversely affected.
As a condition to the initial FDA approval of the platelet system, we are required to conduct a post-approval clinical study of the
platelet system. Successful enrollment and completion of this study requires that we develop sufficient INTERCEPT production
capabilities with U.S. blood center customers. Delays in delivering INTERCEPT systems to blood centers that can supply
INTERCEPT-treated platelets to hospitals involved in the study may lead to increased costs to us and may jeopardize our ability to
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complete the study in a timeframe acceptable to the FDA. In addition, we must identify and contract with hospitals that have the desire
and ability to participate and contribute to the study in a timely manner and who are willing to purchase INTERCEPT-treated platelets
from our blood center customers. If we are unable to complete this study, in a timely manner or at all, or the results of this study reveal
unacceptable safety risks, we could be required to perform additional studies, which may be costly, and even lose U.S. marketing
approval of the platelet system. Further, we are required to conduct a post-approval recovery and survival clinical study in connection
with the recent label expansion approval for the use of the platelet system to treat platelets suspended in 100% plasma. Successful
enrollment and completion of this additional study will also require that we identify and contract with hospitals that have the desire
and ability to participate and contribute to the study in a timely manner and who are willing to purchase INTERCEPT-treated platelets
from our blood center customers. If we are unable to complete this study, in a timely manner or at all, or the results of this study reveal
unacceptable safety risks, we could be required to perform additional studies, which may be costly. In addition to these studies, the
FDA may also require us to commit to perform other lengthy post-marketing studies, for which we would have to expend significant
additional resources, which could have an adverse effect on our operating results, financial condition and stock price. In addition,
there is a risk that these studies will show results inconsistent with our previous studies. Should this happen, potential customers may
delay or choose not to adopt the INTERCEPT Blood System and existing customers may cease use of the INTERCEPT Blood
System.
The execution and completion of our ongoing IDE studies will continue to result in additional costs, and will continue to require
attention and resources from our clinical, regulatory and management teams, which may adversely affect our commercialization
efforts and other regulatory and clinical programs.
Post-Marketing Approval
We are also required to continue to comply with applicable FDA and other regulatory requirements now that we have obtained
approval for the INTERCEPT Blood System for platelets and plasma. These requirements relate to, among other things, labeling,
packaging, storage, advertising, promotion, record-keeping and reporting of safety and other information. In addition, our
manufacturers and their facilities are required to comply with extensive FDA and foreign regulatory agency requirements, including,
in the U.S., ensuring that quality control and manufacturing procedures conform to cGMP and current QSR requirements. As such, we
and our contract manufacturers are subject to continual review and periodic inspections. Accordingly, we and others with whom we
work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and
quality control. We are also required to report certain adverse events and production problems, if any, to the FDA and foreign
regulatory authorities, when applicable, and to comply with requirements concerning advertising and promotion for our products. For
example, our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including
the prohibition of the promotion of unapproved, or off-label, use. If the FDA determines that our promotional materials or training
constitutes promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to
regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or
criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our
promotional or training materials to constitute promotion of an off-label use, or a violation or any other federal or state law that
applies to us, such as laws prohibiting false claims for reimbursement. Any enforcement action brought by a federal, state or foreign
authority could result in significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, exclusion from
participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual
whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages,
administrative burdens, diminished profits and future earnings, additional reporting requirements and/or oversight if we become
subject to a corporate integrity agreement or similar agreement. In addition, our reputation could be damaged and adoption of the
products could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our
products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition,
the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend,
divert our management’s attention, result in substantial damage awards against us and harm our reputation.
Should a regulatory agency question a reported adverse event, we may not be able to rule out product failure as the cause, whether or
not product failure is the cause of the reported adverse event. If a regulatory agency suspects or discovers problems with a product,
such as adverse events of unanticipated severity or frequency, or problems with the facility or the manufacturing process at the facility
where the product is manufactured, or problems with the quality of product manufactured, or disagrees with the promotion, marketing,
or labeling of a product, a regulatory agency may impose restrictions on use of that product, including requiring withdrawal of the
product from the market. Our failure to comply with applicable regulatory requirements could result in enforcement action by
regulatory agencies, which may include any of the following sanctions:
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repair, replacement, recall or seizure of our products;
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operating restrictions or partial suspension or total shutdown of production;
delaying or refusing our requests for approval of new products, new intended uses or modifications to our existing
products and regulatory strategies;
refusal to grant export or import approval for our products;
withdrawing marketing approvals that have already been granted, resulting in prohibitions on sales of our products; and
criminal prosecution.
Any of these actions, in combination or alone, could prevent us from selling our products and harm our business. In addition, any
government investigation of alleged violations of law could require us to expend significant time and resources in response and could
generate negative publicity. Any failure to comply with ongoing or changing regulatory requirements may significantly and adversely
affect our ability to successfully commercialize and generate additional revenues from our platelet and plasma systems or any future
products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results
will be adversely affected. Additionally, if we are unable to continue to generate revenues from the sale of our platelet and plasma
systems, our potential for achieving operating profitability will be diminished and the need for additional capital to fund our
operations will be increased.
In addition, the regulations to which we are subject are complex and have tended to become more stringent over time. Regulatory
changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than
anticipated sales.
A significant portion of the funding for the development of the red blood cell system is expected to come from our BARDA
agreement, and if BARDA were to eliminate, reduce or delay funding from our agreement, this could have a significant, negative
impact on our revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development
program or obtain alternative sources of funding.
We anticipate that a significant portion of the funding for the development of the red blood cell system will come from our agreement
with BARDA. In this regard, in June 2016, we entered into an agreement with BARDA that is worth up to approximately $185.0
million to support the development of the red blood cell system. However, our agreement with BARDA only reimburses certain
specified development and clinical activities that have been previously authorized by BARDA pursuant to the base period and certain
options of the agreement and the potential exercise of subsequent option periods. To date, BARDA has committed only approximately
$41.6 million under the base period of the agreement and options exercised in 2016. Accordingly, our ability to receive any of the
additional $143.4 million in funding provided for under the BARDA agreement is dependent on BARDA exercising subsequent
options under the agreement, which it may do or not do at its sole discretion. In addition, BARDA is entitled to terminate our BARDA
agreement for convenience at any time, in whole or in part, and is not required to provide continued funding beyond amounts currently
obligated under the agreement. Moreover, the continuation of our BARDA agreement depends in large part on our ability to meet
development milestones previously agreed to with BARDA and on our compliance with certain operating procedures and protocols.
BARDA may suspend or terminate the agreement should we fail to achieve key milestones, or fail to comply with the operating
procedures and processes approved by BARDA and its audit agency. There can be no assurance that we will be able to achieve these
milestones or continue to comply with these procedures and protocols. Our ability to meet the expectations of BARDA under our
contract is largely dependent on our ability to attract, hire and retain personnel with competencies that are in short supply. In addition,
in many instances we must identify third-party suppliers, negotiate terms acceptable to us and BARDA and ensure ongoing
compliance by these suppliers with the obligations covered by our BARDA contract. If we are unable to provide adequate supplier
oversight or if suppliers are unable to comply with the requirements of the contract, our ability to meet the anticipated milestones may
be impaired. There can also be no assurance that our BARDA agreement will not be terminated, that our BARDA agreement will be
extended through the exercise of subsequent option periods, that any such extensions would be on terms favorable to us, or that we
will otherwise obtain the funding that we anticipate to obtain under our agreement with BARDA. Moreover, changes in government
budgets and agendas may result in a decreased and deprioritized emphasis on supporting the development of pathogen reduction
technology. If our BARDA agreement is terminated or suspended, if there is any reduction or delay in funding under our BARDA
agreement, or if BARDA determines not to exercise some or all of the options provided for under the agreement, our revenues and
cash flows could be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not
be available on non-dilutive terms, terms favorable to us or at all. If alternative sources of funding are not available, we may be forced
to suspend or terminate development activities related to the red blood cell system in the U.S.
In addition, under the BARDA agreement, BARDA will regularly review our development efforts and clinical activities. Under certain
circumstances, BARDA may advise us to delay certain activities and invest additional time and resources before proceeding. If we
follow such BARDA advice, overall red blood cell program delays and costs associated with additional resources for which we had
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not planned may result. Also, the costs associated with following such advice may or may not be reimbursed by BARDA under our
agreement. Finally, we may decide not to follow the advice provided by BARDA and instead pursue activities that we believe are in
the best interests of our red blood cell program and Cerus, even if BARDA would not reimburse us under our agreement.
Unfavorable provisions in government contracts, including in our contract with BARDA, may harm our business, financial
condition and operating results.
U.S. government contracts typically contain unfavorable provisions and are subject to audit and modification by the government at its
sole discretion, which will subject us to additional risks. For example, under our agreement with BARDA, the U.S. government has
the power to unilaterally:
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audit and object to any BARDA agreement-related costs and fees on grounds that they are not allowable under the Federal
Acquisition Regulation, or FAR, and require us to reimburse all such costs and fees;
suspend or prevent us for a set period of time from receiving new contracts or grants or extending our existing agreement
based on violations or suspected violations of laws or regulations;
claim nonexclusive, nontransferable rights to product manufactured and intellectual property developed under the
BARDA agreement and may, under certain circumstances involving public health and safety, license such inventions to
third parties without our consent;
cancel, terminate or suspend our BARDA agreement based on violations or suspected violations of laws or regulations;
terminate our BARDA agreement in whole or in part for the convenience of the government for any reason or no reason,
including if funds become unavailable to the U.S. Department of Health and Human Services’ Office of the Assistant
Secretary for Preparedness and Response;
reduce the scope and value of our BARDA agreement;
decline to exercise an option to continue the BARDA agreement;
direct the course of the development of the red blood cell system in a manner not chosen by us;
require us to perform the option periods provided for under the BARDA agreement even if doing so may cause us to
forego or delay the pursuit of other red blood cell program opportunities with greater commercial potential;
take actions that result in a longer development timeline than expected;
limit the government’s financial liability to amounts appropriated by the U.S. Congress on a fiscal-year basis, thereby
leaving some uncertainty about the future availability of funding for the red blood cell program even after it has been
funded for an initial period; and
change certain terms and conditions in our BARDA agreement.
Generally, government contracts, including our agreement with BARDA, contain provisions permitting unilateral termination or
modification, in whole or in part, at the U.S. government’s convenience. Termination-for-convenience provisions generally enable us
to recover only our costs incurred or committed (plus a portion of the agreed fee) and settlement expenses on the work completed prior
to termination. Except for the amount of services received by the government, termination-for-default provisions do not permit
recovery of fees. In addition, in the event of termination or upon expiration of our BARDA agreement, the U.S. government may
dispute wind-down and termination costs and may question prior expenses under the contract and deny payment of those expenses.
Should we choose to challenge the U.S. government for denying certain payments under our BARDA agreement, such a challenge
could subject us to substantial additional expenses that we may or may not recover. Further, if our BARDA agreement is terminated
for convenience, or if we default by failing to perform in accordance with the contract schedule and terms, a significant negative
impact on our cash flows and operations could result.
In addition, government contracts normally contain additional requirements that may increase our costs of doing business and expose
us to liability for failure to comply with these terms and conditions. These requirements include, for example:
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specialized accounting systems unique to government contracts;
mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such
funds have been spent;
public disclosures of certain contract information, which may enable competitors to gain insights into our research
program;
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mandatory internal control systems and policies; and
mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affirmative action
programs and environmental compliance requirements.
If we fail to maintain compliance with these requirements, we may be subject to potential liability and to the termination of our
BARDA agreement.
Furthermore, we will enter into agreements and subcontracts with third parties, including suppliers, consultants and other third-party
contractors, in order to satisfy our contractual obligations under our BARDA agreement. Negotiating and entering into such
arrangements can be time-consuming and we may not be able to reach agreement with such third parties. Any such agreement must
also be compliant with the terms of our BARDA agreement. Any delay or inability to enter into such arrangements or entering into
such arrangements in a manner that is non-compliant with the terms of our contract, may result in violations of our BARDA
agreement.
As a result of the unfavorable provisions in our BARDA agreement, we must undertake significant compliance activities. The
diversion of resources from our development and commercial programs to these compliance activities, as well as the exercise by the
U.S. government of any rights under these provisions, could materially harm our business.
Laws and regulations affecting government contracts, including our BARDA agreement, make it more costly and difficult for us to
successfully conduct our business. Failure to comply with these laws and regulations could result in significant civil and criminal
penalties and adversely affect our business.
We must comply with numerous laws and regulations relating to the administration and performance of our BARDA agreement.
Among the most significant government contracting regulations are:
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the FAR and agency-specific regulations supplemental to the FAR, which comprehensively regulate the procurement,
formation, administration and performance of government contracts;
the business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government
employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as
the Anti-Kickback Statute, the Procurement Integrity Act, the False Claims Act and the U.S. Foreign Corrupt Practices
Act;
export and import control laws and regulations; and
laws, regulations and executive orders restricting the exportation of certain products and technical data.
In addition, as a U.S. government contractor, we are required to comply with applicable laws, regulations and standards relating to our
accounting practices and are subject to periodic audits and reviews. As part of any such audit or review, the U.S. government may
review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing,
property, estimating, compensation and management information systems. Based on the results of its audits, the U.S. government may
adjust our BARDA agreement-related costs and fees, including allocated indirect costs. This adjustment could impact the amount of
revenues reported on a historic basis and could impact our cash flows under the contract prospectively. In addition, in the event
BARDA determines that certain costs and fees were unallowable or determines that the allocated indirect cost rate was higher than the
actual indirect cost rate, BARDA would be entitled to recoup any overpayment from us as a result. In addition, if an audit or review
uncovers any improper or illegal activity, we may be subject to civil and criminal penalties and administrative sanctions, including
termination of our BARDA agreement, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing
business with the U.S. government. We could also suffer serious harm to our reputation if allegations of impropriety were made
against us, which could cause our stock price to decline. In addition, under U.S. government purchasing regulations, some of our costs
may not be reimbursable or allowed under our contracts. Further, as a U.S. government contractor, we are subject to an increased risk
of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities as compared to private
sector commercial companies.
If we or our third-party suppliers fail to comply with the FDA’s good manufacturing practice regulations, it could impair our
ability to market our products in a cost-effective and timely manner.
In order to be used in clinical studies or sold in the U.S., our products are required to be manufactured in FDA-approved facilities. If
any of our suppliers fail to comply with FDA’s cGMP regulations or otherwise fail to maintain FDA approval, we may be required to
identify an alternate supplier for our products or components. Our products are complex and difficult to manufacture. Finding alternate
facilities and obtaining FDA approval for the manufacture of the INTERCEPT Blood System at such facilities would be costly and
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time-consuming and would negatively impact our ability to generate revenue from the sale of our platelet or plasma system in the U.S.
and achieve operating profitability.
We and our third-party suppliers are also required to comply with the FDA-mandated cGMP and QSR requirements, which cover the
methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage
and shipping of our products. The FDA audits compliance with cGMP and QSR requirements through periodic announced and
unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time. If we or our
suppliers fail to adhere to cGMP and QSR requirements, have significant non-compliance issues or fail to timely and adequately
respond to any adverse inspectional observations or product safety issues, or if any corrective action plan that we or our suppliers
propose in response to observed deficiencies is not sufficient, the FDA could take enforcement action against us, which could delay
production of our products and may include:
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untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions;
customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for premarket approval of new products or modified products;
withdrawing marketing approvals that have already been granted;
refusal to grant export or import approval for our products; or
criminal prosecution.
Any of the foregoing actions could have a material adverse effect on our reputation, business, financial condition and operating
results. Furthermore, our key suppliers may not continue to be in compliance with all applicable regulatory requirements, which could
result in our failure to produce our products on a timely basis and in the required quantities, if at all. In addition, before any additional
products would be considered for marketing approval in the U.S. or elsewhere, our suppliers will have to pass an audit by the FDA or
other regulatory agencies. We are dependent on our suppliers’ cooperation and ability to pass such audits. Such audits and any audit
remediation may be costly. Failure to pass such audits by any of our suppliers would affect our ability to obtain licensure in the U.S.
or elsewhere.
If we modify our FDA-approved products, we may need to seek additional approvals, which, if not granted, would prevent us from
selling our modified products.
Any modifications to the platelet and plasma systems that could significantly affect their safety or effectiveness, including significant
design and manufacturing changes, or that would constitute a major change in their intended use, manufacture, design, components, or
technology requires approval of a new PMA or PMA supplement. However, certain changes to a PMA-approved device do not require
submission and approval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The FDA
requires every supplier to make this determination in the first instance, but the FDA may review any supplier’s decision. The FDA
may not agree with our decisions regarding whether new clearances or approvals are necessary. Our products could be subject to recall
if the FDA determines, for any reason, that our products are not safe or effective or that appropriate regulatory submissions were not
made. If new regulatory approvals are required, this could delay or preclude our ability to market the modified system. For example,
due to the obsolescence of certain parts, we have redesigned the illuminators used in the platelet and plasma systems, and we will need
to receive approval of this redesign from the FDA. In addition, in order to address the entire market in the U.S., we will need to obtain
approval for additional configurations of the platelet system, including triple dose collections and random donor platelets. Our
approved labels from the FDA limit our current approvals to certain platelet collection platforms and a particular storage solution for
the particular collection platform. For instance, our approved claims permit apheresis collection of platelets on the Fresenius-Kabi
Amicus device while stored in an additive solution or for apheresis collection of platelets collected on the Terumo Trima device and
stored in 100% plasma. Such discrepant collection methodologies and storage solutions and conditions also exist for red blood cells.
We may be required to provide the FDA with data for each permutation for which blood banking treatment practices exist which may
be time consuming, costly and limit the potential size of the U.S. market that can use our products. We have conducted and are
conducting additional in vitro studies for our platelet system to potentially expand our label claims to include, among others, platelets
collected from pooled random donors, storage of INTERCEPT-treated platelets for up to seven days rather than five days, and a new
processing set for triple dose collections. Our failure to obtain FDA and foreign regulatory approvals of new platelet and plasma
product configurations could significantly limit revenues from sales of the platelet and plasma systems. In any event, delays in receipt
or failure to receive approvals, the loss of previously received approvals, or the failure to comply with any other existing or future
regulatory requirements, could reduce our sales and negatively impact our profitability potential and future growth prospects. In
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addition, if the FDA or other regulatory or accrediting body were to mandate safety interventions, including the option of pathogen
reduction technology, when we had not received approval for all operational configurations, the market to which we could sell our
products may be limited until we obtain such approvals, if ever, or may be permanently impaired if competing options are more
broadly available.
We operate a complex global commercial organization, with limited experience in many countries, including the U.S. We have
limited resources and experience complying with regulatory, legal, tax and political complexities as we expand into new and
increasingly broad geographies.
We are responsible for worldwide sales, marketing, distribution, maintenance and regulatory support of the INTERCEPT Blood
System. If we fail in our efforts to develop or maintain such internal competencies or establish acceptable relationships with third
parties to support us in these areas on a timely basis, our ability to commercialize the INTERCEPT Blood System may be irreparably
harmed.
We have a wholly-owned subsidiary, headquartered in the Netherlands, dedicated primarily to selling and marketing the platelet and
plasma systems in Europe, the CIS and the Middle East. Our commercial activities for the U.S., Latin and South America and Asia are
based out of our headquarters in Concord, California with certain support from our European headquarters in the Netherlands, with
certain individuals servicing Latin and South America and Asia, domiciled outside of the U.S. Our commercial organization focused
on the U.S. market has limited resources and is relatively inexperienced, and as a result, has limited to no experience selling and
marketing our platelet and plasma systems. Given the large relative size of the American Red Cross, should they deploy INTERCEPT
rapidly under our commercial agreement, our resources may be inadequate to fulfill the American Red Cross’s and other customers’
demands, which could result in a loss of revenues or customer contracts, or both. We will need to maintain and may need to increase
our competence and size in a number of functions, including sales, deployment and product support, marketing, regulatory, inventory
and logistics, customer service, credit and collections, risk management, and quality assurance systems in order to successfully
support our commercialization activities in all of the jurisdictions we currently sell and market, or anticipate selling and marketing,
our products. Many of these competencies require compliance with U.S., E.U., South American, Asian and local standards and
practices, including regulatory, legal and tax requirements, with some of which we have limited experience. In this regard, should we
obtain regulatory approval in an increased number of geographies, we will need to ensure that we maintain a sufficient number of
personnel or develop new business processes to ensure ongoing compliance with the multitude of regulatory requirements in those
territories. Hiring, training and retaining new personnel is costly, time consuming and distracting to existing employees and
management. We have limited experience operating on a global scale and we may be unsuccessful complying with the variety and
complexity of laws and regulations in a timely manner, if at all. In addition, in some cases, the cost of obtaining approval and
maintaining compliance with certain regulations and laws may exceed the revenue that we recognize from such a territory, which
would adversely affect our results of operations and could adversely affect our financial condition.
Further, in June 2016, the U.K. held a referendum in which voters approved an exit from the E.U., commonly referred to as “Brexit”.
A withdrawal could, among other outcomes, disrupt the free movement of goods, services and people between the U.K. and the E.U.,
undermine bilateral cooperation in key policy areas and significantly disrupt trade between the U.K. and the E.U. We may also face
new regulatory costs and challenges as result of Brexit that could have a material adverse effect on our operations. In addition, Brexit
could lead to legal uncertainty and potentially divergent national laws and regulations as the U.K. determines which E.U. laws to
replace or replicate. Altered regulations could add time and expense to the process by which our product candidates receive regulatory
approval in the E.U. Given the lack of comparable precedent, it is unclear what financial, regulatory, trade and legal implications the
withdrawal of the U.K. from the E.U. will have and how such withdrawal will affect us.
We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain
countries.
We have entered into distribution agreements, generally on a geographically exclusive basis, with distributors in certain regions. We
rely on these distributors to obtain and maintain any necessary in-country regulatory approvals, as well as market and sell the
INTERCEPT Blood System, provide customer and technical product support, maintain inventories, and adhere to our quality system
in all material respects, among other activities. Generally, our distribution agreements require distributors to purchase minimum
quantities in a given year over the term of the agreement. Failure by our distributors to meet these minimum purchase obligations may
impact our financial results. In addition, failure by our distributors to provide an accurate forecast impacts our ability to predict the
timing of revenue and our ability to accurately forecast our product supply needs. While our contracts generally require distributors to
exercise diligence, these distributors may fail to commercialize the INTERCEPT Blood System in their respective territories. For
example, our distributors may fail to sell product inventory they have purchased from us to end customers or may sell competing
products ahead of or in conjunction with INTERCEPT. In addition, initial purchases of illuminators or INTERCEPT disposable kits
by these third parties may not lead to follow-on purchases of platelet and plasma systems’ disposable kits. Agreements with our
distributors typically require the distributor to maintain quality standards that are compliant with standards generally accepted for
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medical devices. We may be unable to ensure that our distributors are compliant with such standards. Further, we have limited
visibility into the identity and requirements of blood banking customers these distributors may have. Accordingly, we may be unable
to ensure our distributors properly maintain illuminators sold or provide quality technical services to the blood banking customers to
which they sell. In addition, although our agreements with our distributors generally require compliance with local anti-corruption
laws, the U.S. Foreign Corrupt Practices Act, and other local and international regulations, we have limited ability to control the
actions of our distributors to ensure they are in compliance. Noncompliance by a distributor could expose us to civil or criminal
liability, fines and/or prohibitions on selling our products in certain countries.
Currently, a fairly concentrated number of distributors make up a significant portion of our revenue and we may have little recourse,
short of termination, in the event that a distributor fails to execute according to our expectations and contractual provisions. In the
past, we have experienced weaker than expected growth due to declining performance by certain of our distributors. Periodically, we
transition certain territories to new distribution partners or our direct sales force where we believe we can improve performance
relative to the distributor. Because new distribution partners or our direct sales force may have limited experience marketing and
selling our products in certain territories, or at all, we cannot be certain that they will perform better than the predecessor distributor.
In certain cases, our distributors hold the regulatory approval to sell INTERCEPT for their particular geography. Termination, loss of
exclusivity or transitioning from these distributors would require us to negotiate a transfer of the applicable regulatory approvals to us
or new distributors which may be difficult to do in a timely manner, or at all. We expect that our product revenues will be adversely
impacted with the loss or transition of one or more of these distributors. If we chose to terminate additional distributor agreements, we
would either need to reach agreement with, qualify, train and supply a replacement distributor or supply and service end-user customer
accounts in those territories ourselves. Although our distribution agreements generally provide that the distributor will promptly and
efficiently transfer its existing customer agreements to us, there can be no assurance that this will happen in a timely manner or at all.
In addition, terminated distributors may own illuminators placed at customer sites and may require us to repurchase those devices or
require end-user customers to purchase new devices from us. Additionally, we may need terminated distributors to cooperate with us
or a new distributor in transitioning sub-distributor relationships and contracts, hospital contracts, or public tenders. These factors
may be disruptive for our customers and our reputation may be damaged as a result. Our distribution partners may have more
established relationships with potential end user customers than a new distributor or we may have in particular territory, which could
adversely impact our ability to successfully commercialize our products in these territories. In addition, it may take longer for us to be
paid if payment timing and terms in these new arrangements are less favorable to us than those in our existing distributor
arrangements. As we service end-user accounts directly rather than through distributors, we incur additional expense, our working
capital is negatively impacted due to longer periods from cash collection from direct sales customers when compared to the timing of
cash collection from our former distribution partners and we may be exposed to additional complexity including local statutory and
tax compliance. Current or transitioning distributors may irreparably harm relationships with local existing and prospective customers
and our standing with the blood banking community in general. In the event that we are unable to find alternative distributors or
mobilize our own sales efforts in the territories in which a particular distributor operates, customer supply, our reputation and our
operating results may be adversely affected. In addition, in territories where new distributors are responsible for servicing end-user
accounts, there will be a period of transition in order to properly qualify and train these new distributors, which may disrupt the
operations of our customers and adversely impact our reputation and operating results.
Our products are a novel technology in the U.S. and blood centers and clinicians have little to no experience with pathogen
reduction systems. Further, we have no prior experience commercializing products in the U.S. We may be unable to develop and
maintain an effective and qualified U.S. based commercial organization or educate blood centers, clinicians and hospital
personnel. As a result, we may not be able to successfully educate the market on the value of pathogen reduction or commercialize
our platelet and plasma systems in the U.S.
Our ability to generate significant revenue from our platelet and plasma systems depends in part on our ability to achieve market
acceptance of, and to otherwise effectively market, our platelet and plasma systems in the U.S. Even if we are able to achieve market
acceptance in the U.S. or newly commercialized markets, we have provided and may continue to provide adoption incentives which
may negatively impact our reported sales. As a company, we have no prior experience in commercializing any products in the U.S.
and we will need to attract, retain, train and support sales, marketing and scientific affairs personnel and other commercial talent. For
example, we will need to attract and retain medical science liaisons, or MSLs, to help educate hospitals and physicians on our
products, clinical trial history and publications. MSLs are highly educated and trained professionals and the hiring and employment
market for MSLs is highly competitive. As such, we will need to commit significant additional management and other resources in
order to maintain and expand our MSL team and sales and marketing functions. We may be unable to develop and maintain adequate
MSL, sales and marketing capabilities for the U.S. market and we also may not be able to devote sufficient resources to the
advertising, promotion and sales efforts for the platelet and plasma systems in the U.S. We will also have to compete with other life
sciences and medical device companies to recruit, hire, train and retain the MSL, sales and marketing personnel that we anticipate we
will need in the future. For these and other reasons, we may be unable to develop and maintain an effective and qualified U.S.-based
commercial organization in a cost-effective manner or realize a positive return on our investment. If we are unable to develop and
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maintain an effective and qualified U.S.-based commercial organization in a timely manner or at all, we may fail to realize the full
sales potential of our platelet and plasma systems in the U.S.
Our manufacturing supply chain exposes us to significant risks.
We do not own our own manufacturing facilities, but rather manufacture our products using a number of third party suppliers, many of
whom are our sole suppliers for the particular product or component that we procure. We rely on various contracts and our
relationships with these suppliers to ensure that the sourced products are manufactured in sufficient quantities, timely, to our exact
specifications and at prices we agree upon with the supplier. The price that we pay to some of our suppliers is dependent on the
volume of products or components that we order. If we are unable to meet the volume tiers that afford the most favorable pricing, our
margins will decrease.
In October 2015, we amended and restated our manufacturing and supply agreement with Fresenius. Under the amended agreement,
Fresenius is obligated to sell, and we are obligated to purchase finished disposable kits for the platelet, plasma and red blood cell kits
from Fresenius with certain exceptions permitted. The initial term of the amended agreement extends through July 1, 2025, and is
automatically renewed thereafter for additional two year renewal terms, subject to termination by either party upon (i) two years
written notice prior to the expiration of the initial term or (ii) one year written notice prior to the expiration of any renewal term. We
and Fresenius each have normal and customary termination rights, including termination for material breach. Fresenius is our sole
supplier for the manufacture of these products. Fresenius may fail to manufacture an adequate supply of INTERCEPT disposable kits
which would harm our business. Disruptions to our supply chain as a result of any potential ensuing protests, strikes or other work-
stoppages would be detrimental to our business and operating results. While we and Fresenius recently entered into the amended
agreement, in the event Fresenius refuses or is unable to continue operating under the amended agreement, we may be unable to
maintain inventory levels or otherwise meet customer demand, and our business and operating results would be materially and
adversely affected.
We also have contracts with other third-party suppliers, including Ash Stevens for the manufacture of amotosalen, our proprietary
compound for reducing pathogens that is used in our platelet and plasma systems; Purolite, and separately, Porex, for the manufacture
of components of the compound adsorption devices used in our platelet and plasma systems; and NOVA for the manufacture of
illuminators and certain components of the INTERCEPT Blood System. These independent suppliers are currently our sole qualified
suppliers for such components and products.
Our manufacturing and supply agreement with Ash Stevens currently extends through December 31, 2017, and is automatically
renewable thereafter for periods of two years each, but may be terminated by Ash Stevens provided that Ash Stevens notifies us in
writing at least two years in advance. Although we are not subject to minimum annual purchase requirements under the manufacturing
and supply agreement with Ash Stevens, we may be required to pay a maintenance fee of up to $50,000 a year if specified quantities
of amotosalen are not purchased in any year. We have incurred these maintenance fees in the past and may incur these maintenance
fees in future periods.
Our supply agreement with Porex has been extended until March 31, 2017 to allow us and Porex to negotiate a mutually agreeable
amendment to our supply agreement. Porex is our sole supplier for certain components of the compound adsorption devices. We are
subject to certain minimum annual purchase requirements under our agreement with Porex and are required to compensate Porex if we
do not meet such minimum annual purchase requirements. Although we are actively seeking to develop alternative manufacturers and
components, commercially viable alternatives are likely at least a year away. Any new agreement or amendment to the existing Porex
agreement may contain terms that are unfavorable to us relative to existing terms or we may not reach agreement with Porex at all
which would impact our ability to produce and supply qualified components. We entered into an amended and restated supply
agreement with Purolite, which supplies other components of the compound adsorption devices, in April 2014. The amended supply
agreement expires in April 2021 and will automatically renew for an additional year unless either party has provided notice not to
renew at least two years prior to the expiration. Under the terms of the amended agreement, pricing is volume based and is subject to
annual, prospective adjustments based on a Producer Price Index subject to an annual cap. Our agreement with NOVA, which
manufacturers our illuminators, currently extends through September 2017 and is automatically renewable for one year terms, but may
be terminated by NOVA on at least twelve months’ prior written notice. We have not been notified by NOVA of their intention to
terminate the agreement.
Facilities at which the INTERCEPT Blood System or its components are manufactured may cease operations for planned or
unplanned reasons or may unilaterally change the formulations of certain commercially available reagents that we use, causing at least
temporary interruptions in supply. Even a temporary failure to supply adequate numbers of INTERCEPT Blood System components
may cause an irreparable loss of customer goodwill. Although we are actively evaluating alternate suppliers for certain components,
we do not have qualified suppliers beyond those on which we currently rely, and we understand that Fresenius relies substantially on
sole suppliers of certain materials for our products. In addition, suppliers that our contract manufacturers source components and raw
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materials from may cease production of or providing those components to our contract manufacturers. For example, we understand
that certain plastics used to make INTERCEPT disposable kits will only be available for a finite period of time. As a result, we and
our manufacturers have identified alternate plastics but will need to qualify and validate those plastics before we can utilize them in
commercial manufacturing. Identification and qualification of alternate suppliers will be time consuming and costly. If we conclude
that supply of the INTERCEPT Blood System or components from Fresenius and others is uncertain, we may choose to build and
maintain inventories of raw materials, work-in-process components, or finished goods, which would consume capital resources faster
than we anticipate and may cause our supply chain to be less efficient.
Currently NOVA is manufacturing illuminators to meet customer demand and maintain our own inventory levels. Subject to
obsolescence, we may be required to identify and qualify replacement components for illuminators and in doing so, we may be
required to conduct additional studies, which could include clinical trials to demonstrate equivalency or validate any required design
or component changes. We and our customers rely on the availability of spare parts to ensure that customer platelet and plasma
production is not interrupted. If we are not able to supply spare parts for the maintenance of customer illuminators, our ability to keep
existing customers or sign up new customers may be negatively impacted. Due to the obsolescence of certain parts, which are in
limited supply, we have redesigned the illuminators used in the platelet and plasma systems, and we will need to receive approval of
this redesign from the FDA. Our failure to obtain FDA and foreign regulatory approvals of a new illuminator could constrain our
ability to penetrate the U.S. market and may otherwise significantly limit revenues from sales of the platelet and plasma systems. In
any event, delays in receipt or failure to receive these approvals could reduce our sales and negatively impact our profitability
potential and future growth prospects. In addition, our illuminators contain embedded proprietary software that runs on software code
we have developed and that we own. Changes to certain components due to obsolescence, illuminator redesign or market demand,
may require us to modify the existing software code or to develop new illuminator software. Our ability to develop new illuminator
software, correct coding flaws and generally maintain the software code is reliant on third-party contractors who, in some cases, have
sole knowledge of the software code. Our ability to develop and maintain the illuminator software may be impaired if we are not able
to continue contracting with those key third-party contracted developers or if we are unable to source alternate employees or
consultants to do so. Software development is inherently risky and may be time consuming and costly.
In the event that alternate manufacturers are identified and qualified, we will need to transfer know-how relevant to the manufacture of
the INTERCEPT Blood System to such alternate manufacturers; however, certain of our supplier’s materials, manufacturing processes
and methods are proprietary to them, which will impair our ability to establish alternate sources of supply, even if we are required to
do so as a condition of regulatory approval. We may be unable to establish alternate suppliers without having to redesign certain
elements of the platelet and plasma systems. Such redesign may be costly, time consuming and require further regulatory review and
approvals. We may be unable to identify, select, and qualify such manufacturers or those third parties able to provide support for
development and testing activities on a timely basis or enter into contracts with them on reasonable terms, if at all. Moreover, the
inclusion of components manufactured by new suppliers could require us to seek new or updated approvals from regulatory
authorities, which could result in delays in product delivery. We may not receive any such required regulatory approvals. We cannot
assure you that any amendments to existing manufacturing agreements or any new manufacturing agreements that we may enter into
will contain terms more favorable to us than those that we currently have with our manufacturers. Many of the existing agreements we
have with suppliers contain provisions that we have been operating under for an extended period of time, including pricing. Should we
enter into agreements or amend agreements with any manufacturer with less favorable terms, including pricing, our results of
operations may be impacted, our recourse against such manufacturers may be limited, and the quality of our products may be
impacted.
Raw materials, components or finished product may not meet specifications or may be subject to other nonconformities. In the past,
nonconformities in certain component lots have caused delays in manufacturing of INTERCEPT disposable kits. Similarly, we have
experienced non-conformities and out of specification results in certain component manufacturing needed for commercial sale and
regulatory submissions. Non-conformities can increase our expenses and reduce gross margins or result in delayed regulatory
submissions. Should non-conformities occur in the future, we may be unable to manufacture products to meet customer demand,
which would result in lost sales and could cause irreparable damage to our customer relationships. Later discovery of problems with a
product, manufacturer or facility may result in additional restrictions on the product, manufacturer or facility, including withdrawal of
the product from the market. We are subject to risks and costs of product recall, which include not only potential out-of-pocket costs,
but also potential interruption to our supply chain. In such an event, our customer relations could be harmed and we would incur
unforeseen losses.
In the event of a failure by Fresenius or other manufacturers to perform their obligations to supply components of the INTERCEPT
Blood System to us, damages recoverable by us may be insufficient to compensate us for the full loss of business opportunity. Many
of our supply agreements contain limitations on incidental and consequential damages that we may recover. A supplier’s potential
liability in the event of non-performance may not be sufficient to compel the supplier to continue to act in conformity with our
agreements. Our product supply chain requires us to purchase certain components in minimum quantities and may result in a
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production cycle of more than one year. Significant disruptions to any of the steps in our supply chain process may result in longer
productions cycles which could lead to inefficient use of cash or may impair our ability to supply customers with product.
We may encounter unforeseen manufacturing difficulties which, at a minimum, may lead to higher than anticipated costs, scrap rates,
or delays in manufacturing products. In addition, we may not receive timely or accurate demand information from distributors or may
not accurately forecast demand ourselves for the INTERCEPT Blood System. Further, certain customers require, and potential future
customers may require, product with a minimum shelf life. As a result, we may need to manufacture sufficient product to meet that
forecasted demand. As a result, we may carry excess work-in-process or finished goods inventory, which would consume capital
resources and may become obsolete, or our inventory may be inadequate to meet customer demand. We have entered into certain
public tenders, some which call for us to maintain certain minimum levels of inventory. If our suppliers fail to produce components or
our finished products satisfactorily, timely, at acceptable costs, and in sufficient quantities, we may incur delays, shortfalls and
additional expenses, or non-compliance with certain public tenders which may in turn result in permanent harm to our customer
relations or loss of customers. Conversely, we may choose to overstock inventory in order to mitigate any unforeseen potential
disruption to manufacturing which could consume our cash resources faster than we anticipate and may cause our supply chain to be
less efficient. Our platelet and plasma systems’ disposable kits have a two-year shelf life from the date of manufacture. Should we
change or modify and of our product configurations or components, such future configurations of our products may not achieve the
same shelf life that existing products have. In addition, we and our distributors may be unable to ship product to customers prior to
the expiration of the product shelf life, a risk that is heightened if we elect to increase our inventory levels in order to mitigate supply
disruptions. Certain customers may require product with a minimum shelf life remaining prior to shipment. If customers requiring
minimum shelf-lives order smaller quantities or do not purchase product as we anticipate, or at all, we may have elevated inventory
levels with relatively short shelf-lives which may lead to increased write-offs and inefficient use of our cash. Should we chose not to
fulfill smaller orders with minimum shelf lives, our product sales may be harmed. We will need to destroy or consume outdated
inventory in product demonstration activities, which may in turn lead to elevated product demonstration costs and/or reduced gross
margins.
Shortage of key components of and accessories to the INTERCEPT Blood System, such as plastics, saline or other reagents may
impact operational costs of our customers and may increase the prices at which we sell our products, resulting in slower than
anticipated growth or negative future financial performance.
The manufacture, supply and availability of key components of, and accessories to, our products are dependent upon a limited number
of third parties and the commercial adoption and success of our products is dependent upon the continued availability of these
components or accessories. For example, our customers rely on continued availability of third-party supplied plastics, saline and
reagents for processing, storing and manufacturing blood components. If the blood product industry experiences shortages of these
components or accessories, the availability and use of our products may be impaired. Additionally, the current international shortage
of saline has adversely impacted our ability to source the optimal fill weight of saline vials for use in our chronic anemia study of the
red blood cell system. As a result, we were required to purchase saline vials with higher than preferred fill weights at a higher cost.
With respect to the manufacture of our products, our third party manufacturers source plastic for the manufacture of the INTERCEPT
processing sets from a limited number of suppliers and we do not have guaranteed supply contracts with all of the raw material
suppliers for our products, which magnifies the risk of shortage and decreases our manufacturers’ ability to negotiate pricing with their
suppliers. Any shortage of plastics or other components or accessories and the inability to control costs associated with those raw
materials could increase our costs to manufacture our products. Further, if any supplier to our third party manufacturers is unwilling or
unable to provide high quality raw materials in required quantities and at acceptable prices, our manufacturers may be unable to find
alternative sources or may fail to find alternative suppliers at commercially acceptable prices, on satisfactory terms, in a timely
manner, or at all. If any of these events were to occur, our product quality, competitive position, reputation and business could suffer,
we could experience cancellations of customer orders, refusal by customers to accept deliveries or a reduction in our prices and
margins to the detriment of our financial performance and results of operations.
We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial
penalties and harm our reputation and business.
We are subject to a number of laws that affect our sales, marketing and other promotional activities by limiting the kinds of financial
arrangements we may have with hospitals, physicians, healthcare providers or other potential purchasers of our products. These laws
are often broadly written, and it is often difficult to determine precisely how these laws will be applied to specific circumstances. For
example, within the E.U., the control of unlawful marketing activities is a matter of national law in each of the member states. The
member states of the E.U. closely monitor perceived unlawful marketing activity by companies. We could face civil, criminal and
administrative sanctions if any member state determines that we have breached our obligations under its national laws. Industry
associations also closely monitor the activities of member companies. If these organizations or authorities name us as having breached
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our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial condition could
be adversely affected.
In addition, there are numerous U.S. federal and state healthcare regulatory laws, including, but not limited to, anti-kickback laws,
false claims laws, privacy laws, and transparency laws. Our relationships with healthcare providers and entities, including but not
limited to, hospitals, physicians, healthcare providers and our customers are or will be subject to scrutiny under these laws. Violations
of these laws can subject us to penalties, including, but not limited to, administrative, civil and criminal penalties, damages, fines,
disgorgement, imprisonment, exclusion from participation in federal and state healthcare programs, including the Medicare and
Medicaid programs, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or
similar agreement to resolve allegations of non-compliance with these laws, and the curtailment of our operations. Healthcare fraud
and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has
been violated. The laws that may affect our ability to operate include, but are not limited to:
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the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully
offering, paying, soliciting, or receiving, any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in
exchange for or to induce, the referral of an individual for, the purchase, lease, order or recommendation of, any good,
facility, item or service for which payment may be made, in whole or in part, under federal healthcare programs such as
Medicare and Medicaid;
federal false claims laws that prohibit, among other things, knowingly presenting, or causing to be presented, claims for
payment or approval from Medicare, Medicaid or other federal payors that are false or fraudulent, or knowingly making a
false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government, and which
may apply to entities that provide coding and billing advice to customers;
the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is
determined to have presented or caused to be presented, a claim to a federal healthcare program that the person knows, or
should know, is for an item or service that was not provided as claimed or is false or fraudulent;
the federal Health Insurance Portability and Accountability Act of 1996, as amended, or HIPAA, which created federal
criminal laws that prohibit executing a scheme to defraud any healthcare benefit program, including private payors, or
making false statements relating to healthcare matters;
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH,
and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health
plans and healthcare clearinghouses as well as their business associates that perform services for them that involve
individually identifiable health information, relating to the privacy, security and transmission of individually identifiable
health information without appropriate authorization, including mandatory contractual terms as well as directly applicable
privacy and security standards and requirements;
the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; and
foreign or U.S. state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which
may apply to items or services reimbursed by any third-party payor, including commercial insurers; U.S. state laws that
require device companies to comply with the industry’s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the U.S. federal government or otherwise restrict payments that may be made to healthcare
providers; U.S. state laws that require device manufacturers to report information related to payments and other transfers
of value to physicians and other healthcare providers or marketing expenditures; and U.S. state laws governing the privacy
and security of certain health information, many of which differ from each other in significant ways and often are not
preempted by HIPAA, thus complicating compliance efforts.
We are also subject to foreign laws and regulations covering data privacy and the protection of health-related and other personal
information. In this regard, E.U. member states and other foreign jurisdictions, including Switzerland, have adopted data protection
laws and regulations which impose significant compliance obligations. For example, the E.U. Data Protection Directive, as
implemented into national laws by the E.U. member states, imposes strict obligations and restrictions on the ability to collect, analyze
and transfer personal data, including health data from clinical trials and adverse event reporting. The E.U. Data Protection Directive
prohibits the transfer of personal data to countries outside of the European Economic Area, or EEA, such as the U.S., which are not
considered by the European Commission, or EC, to provide an adequate level of data protection. Switzerland has adopted similar
restrictions. Although there are legal mechanisms to allow for the transfer of personal data from the EEA and Switzerland to the U.S.,
a recent judgment of the European Court of Justice that invalidated the EC decision on the U.S. safe harbor has increased uncertainty
around the adequacy of these legal mechanisms. This means that it will no longer be possible to transfer personal data from the E.U. to
entities in the U.S. that rely on safe harbor certification as a legal basis for the transfer of such data. In addition, data protection
authorities from the different E.U. member states may interpret the E.U. Data Protection Directive and national laws differently, and
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guidance on implementation and compliance practices are often updated or otherwise revised, which adds to the complexity of
processing personal data in the E.U. If we fail to comply with applicable data privacy laws, or if the legal mechanisms we rely upon to
allow for the transfer of personal data from the EEA or Switzerland to the U.S. (or other countries not considered by the EC to provide
an adequate level of data protection) are not considered adequate, we could be subject to government enforcement actions and
significant penalties against us, and our business could be adversely impacted if our ability to transfer personal data outside of the
EEA or Switzerland is restricted, which could adversely impact our operating results. Further, a proposal for an E.U. Data Protection
Regulation, intended to replace the current E.U. Data Protection Directive, is currently under consideration. The proposed E.U. Data
Protection Regulation, if adopted, is expected to introduce new data protection requirements and substantial fines for breaches of the
data protection rules. When the draft E.U. Data Protection Regulation is adopted, it may increase our responsibility and liability in
relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the
new E.U. data protection rules.
We are also subject to the U.S. Foreign Corrupt Practices Act and anti-corruption laws, and similar laws with a significant anti-
corruption intent in foreign countries. In general, there is a worldwide trend to strengthen anticorruption laws and their enforcement.
Any violation of these laws by us or our agents or distributors could create a substantial liability for us, subject our officers and
directors to personal liability and also cause a loss of reputation in the market. We currently operate in many countries where the
public sector is perceived as being more or highly corrupt. Our strategic business plans include expanding our business in regions and
countries that are rated as higher risk for corruption activity, such as China, India and Russia. Becoming familiar with and
implementing the infrastructure necessary to comply with laws, rules and regulations applicable to new business activities and
mitigate and protect against corruption risks could be quite costly. In addition, failure by us or our agents or distributors to comply
with these laws, rules and regulations could delay our expansion into high-growth markets, could damage market perception of our
business and could adversely affect our existing business operations. Increased business in higher risk countries could also subject us
and our officers and directors to increased scrutiny and increased liability.
Further, the ACA, among other things, amends the intent requirements of the federal Anti-Kickback Statute and certain criminal
statutes governing healthcare fraud. A person or entity can now be found guilty of violating the statute without actual knowledge of
the statute or specific intent to violate it. In addition, the ACA provides that the government may assert that a claim including items or
services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the
federal False Claims Act. Moreover, while we do not submit claims and our customers make the ultimate decision on how to submit
claims, from time-to-time, we may provide reimbursement guidance to our customers. If a government authority were to conclude that
we provided improper advice to our customers or encouraged the submission of false claims for reimbursement, we could face action
against us by government authorities. Any violations of these laws, or any action against us for violation of these laws, even if we
successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial
condition.
Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such
laws, it is possible that some of our business activities, including our relationships with healthcare providers and entities, including,
but not limited to, hospitals, physicians, healthcare providers and our distributors, and certain sales and marketing practices, including
the provision of certain items and services to our customers, could be subject to challenge under one or more of such laws.
To enforce compliance with the healthcare regulatory laws, federal and state enforcement bodies have recently increased their scrutiny
of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions,
convictions and settlements in the healthcare industry. Responding to investigations can be time-and resource-consuming and can
divert management’s attention from the business. Additionally, as a result of these investigations, healthcare providers and entities
may have to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity
agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
In addition, there has been a recent trend of increased U.S. federal and state regulation of payments and transfers of value provided to
healthcare professionals or entities. Section 6002 of the ACA known as the Physician Payment Sunshine Act that imposes new annual
reporting requirements on device manufacturers for payments and other transfers of value provided by them, directly or indirectly, to
physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their family members. A
manufacturer’s failure to submit timely, accurately and completely the required information for all payments, transfers of value or
ownership or investment interests may result in civil monetary penalties of up to an aggregate of $150,000 per year, and up to an
aggregate of $1.0 million per year for “knowing failures.” Manufacturers must submit reports by the 90th day of each subsequent
calendar year. Due to the difficulty in complying with the Physician Payment Sunshine Act, we cannot assure you that we will
successfully report all payments and transfers of value provided by us, and any failure to comply could result in significant fines and
penalties. Some states, such as California and Connecticut, also mandate implementation of commercial compliance programs, and
other states, such as Massachusetts and Vermont, impose restrictions on device manufacturer marketing practices and tracking and
reporting of gifts, compensation and other remuneration to healthcare professionals and entities. The shifting commercial compliance
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environment and the need to build and maintain robust and expandable systems to comply with different compliance and reporting
requirements in multiple jurisdictions increase the possibility that we may fail to comply fully with one or more of these requirements.
Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be
entirely eliminated. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur
significant legal expenses and divert our management’s attention from the operation of our business.
Most of these laws apply to not only the actions taken by us, but also actions taken by our distributors or other third party agents. We
have limited knowledge and control over the business practices of our distributors and agents, and we may face regulatory action
against us as a result of their actions which could have a material adverse effect on our reputation, business, results of operations and
financial condition.
In addition, the scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of healthcare
reform, especially in light of the lack of applicable precedent and regulations. U.S. federal or state regulatory authorities might
challenge our current or future activities under these laws. Any such challenge could have a material adverse effect on our reputation,
business, results of operations and financial condition. Any U.S. federal or state or foreign regulatory review of us, regardless of the
outcome, would be costly and time-consuming. Additionally, we cannot predict the impact of any changes in these laws, whether or
not retroactive. Compliance with these and other changing regulations will increase our costs and may require increasing management
attention.
Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval of
our products and to produce, market and distribute our products after approval is obtained.
Regulatory guidance and regulations are often revised or reinterpreted by the regulatory agencies in ways that may significantly affect
our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional
costs or lengthen review times of our products. Delays in receipt of, or failure to receive, regulatory approvals for our new products or
product configurations would have a material adverse effect on our business, results of operations and financial condition.
Federal and state governments in the U.S. have recently enacted legislation to overhaul the nation’s healthcare system. While the goal
of healthcare reform is to expand coverage to more individuals, it also involves increased government price controls, additional
regulatory mandates and other measures designed to constrain medical costs. The ACA significantly impacts the medical device
industry. Among other things, the ACA:
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imposes an annual excise tax of 2.3% on entities that manufacture or import eligible medical devices offered for sale in
the U.S.;
establishes a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical
effectiveness research in an effort to coordinate and develop such research;
implements payment system reforms including a national pilot program on payment bundling to encourage hospitals,
physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through
bundled payment models; and
creates an independent payment advisory board that will submit recommendations to reduce Medicare spending if
projected Medicare spending exceeds a specified growth rate.
Since its enactment, there have been judicial and Congressional challenges to numerous provisions of the ACA. In January, Congress
voted to adopt a budget resolution for fiscal year 2017, or the Budget Resolution, that authorizes the implementation of legislation that
would repeal portions of the ACA. The Budget Resolution is not a law, but it is widely viewed as the first step toward the passage of
legislation that would repeal certain aspects of the ACA. Further, on January 20, 2017, President Trump signed an Executive Order
directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the
implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare
providers, health insurers, or manufacturers of pharmaceuticals or medical devices. Congress also could consider subsequent
legislation to replace elements of the ACA that are repealed, which may have the effect of limiting the amounts that governments will
pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressure, or may
lead to significant deregulation, which could make the introduction of competing products and technologies much easier. Policy
changes, including potential modification or repeal of all or parts of the ACA or the implementation of new health care legislation
could result in significant changes to the health care system, which could have a material adverse effect on our business, results of
operations and financial condition.
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In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, President
Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit
Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit
reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several
government programs. This includes reductions to Medicare payments to providers of 2% per fiscal year, which went into effect in
April 2013 and will stay in effect through 2024, unless additional congressional action is taken. On January 2, 2013, President Obama
signed into law the American Taxpayer Relief Act of 2012 which, among other things, further reduced Medicare payments to several
providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers
from three to five years.
In January 2017, President Trump became President of the U.S. The administration has publicly stated a core goal is to deregulate
wherever possible. It is unclear if this contraction in regulation would also apply to guidance documents that would impact our
industry. For example, the FDA has indicated that they will finalize guidance prescribing steps blood centers would have to comply
with to safeguard platelet products from bacterial contamination. The initial draft guidance prescribed our technology as an option.
Should the administration remove such guidance documentation, market uptake for INTERCEPT platelets may be impaired.
Conversely, any significant deregulation could make the introduction of competing products and technologies much easier than the
burden faced by us in order to receive FDA approval. We expect that additional U.S federal and state and foreign healthcare reform
measures will be adopted in the future, any of which could limit the amounts that governments will pay for healthcare products and
services, which could result in reduced demand for our products or additional pricing pressure.
Our platelet and plasma products and product candidates are not compatible with some collection, production and storage methods
or combinations thereof.
The equipment and materials used to collect platelets vary by manufacturer and by geographic region. Platelets may be collected from
a single donor by apheresis using an automated collection machine. Apheresis devices currently used in the U.S. and European
markets differ, among other characteristics, in their ability to collect platelets in reduced volumes of plasma. Platelet collection device
manufacturers may need to modify device collection parameters or software before a prospective customer could use INTERCEPT. If
these manufacturers are not cooperative or are resistant to assist their customers or do not assist with making such modifications, the
potential market for our products may be limited. Platelet concentrates may also be prepared from whole blood by pooling together
platelets from multiple donors. There are two commonly used methods for preparing whole blood platelets: the buffy coat method,
which is used extensively in Europe, and the pooled random donor method, which is used in the U.S. Our platelet system is designed
to work with platelets collected and stored in storage solutions, called InterSol and SSP+, and for platelets suspended in 100% plasma.
Fresenius is the exclusive manufacturer of InterSol and MacoPharma of SSP+, both widely-used platelet additive solutions. Many of
our customers and prospective customers use InterSol or SSP+ in connection with INTERCEPT treatment. Similarly, many of our
customers combine multiple plasma components from whole blood donations before treating the combined plasma product with
INTERCEPT. Grifols makes such a product (Plasmix). Customers’ ability to use our INTERCEPT products may be impaired should
manufacturers of those products, including those sold by Grifols, not provide access to the products allowing for the combination of
multiple components. Should Fresenius, MacoPharma, or Grifols fail to obtain or maintain regulatory approval for InterSol, SSP+, or
Plasmix, respectively, or if any should decide to cease distribution of those respective products to customers and prospective
customers, our ability to sell the INTERCEPT Blood System may be impaired.
In order to address the entire market in the U.S., Japan, and potentially elsewhere, we will need to develop and test additional
configurations of the platelet system. For example, in the U.S., we understand a significant number of platelet concentrates are derived
from larger volumes collected from apheresis donors split into three therapeutic transfusable doses. Future configurations of the
platelet system will be needed to treat platelet donations with such processing parameters. We estimate that the majority of platelets
used in the U.S. are collected by apheresis, though a significant minority is prepared from pooled random donor platelets derived from
whole blood collections. In addition, many blood centers may view pooled random donor platelets treated with INTERCEPT as an
economically optimal approach. In order to gain regulatory approvals for a pathogen reduction system compatible with triple dose
collections, and random donor platelets, we will need to perform additional product development and testing, including additional
clinical trials. We have conducted and are conducting additional in vitro studies for our platelet system to potentially expand our label
claims to include, among others, platelets collected from pooled random donors, storage of INTERCEPT-treated platelets for up to
seven days rather than five days, and a new processing set for triple dose collections. In the U.S, our approved labels for the platelet
system from the FDA limit our current approvals to certain platelet collection platforms and a particular storage solution for the
particular collection platform. For instance, our approved claims permit apheresis collection of platelets on the Fresenius-Kabi Amicus
device while stored in an additive solution or for apheresis collection of platelets collected on the Terumo Trima device and stored in
100% plasma. We may be required to provide the FDA with data for each permutation for which blood banking treatment practices
exist which may be time consuming, costly and limit the potential size of the U.S. market that can use our products. Our failure to
obtain FDA and foreign regulatory approvals of any new configurations could significantly limit revenues from sales of the platelet
system. In addition, given that there is some loss of platelets using our product, blood centers may need to increase collection volumes
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in order to use our product and maintain an adequate concentration for a triple therapeutic dose. In any event, delays in receipt or
failure to receive approval could reduce our sales and negatively impact our profitability potential and future growth prospects.
Similarly, to achieve market acceptance in certain geographies, we may be required to design, develop and test new product
configurations for the platelet and plasma systems. In addition, if the FDA or other regulatory or accrediting body were to mandate
safety interventions, including the option of pathogen reduction technology, when we had not received approval for all operational
configurations, the market to which we could sell our products may be limited until we obtain such approvals, if ever, or may be
permanently impaired if competing options are more broadly available. In addition, we will need to continue to generate acceptable
data in order to conform with the evolving collection practices such as automated whole-blood collection. If we are unable to conform
to evolving collection practices our ability to address those portions of the market may be compromised. These development activities
will increase our costs significantly and may not be successful. We may need to demonstrate the safety and efficacy of our platelet
system using a variety of configurations before our platelet system would be approved for such configurations. Delays in obtaining
any future approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn
would harm our revenue and potential future profitability.
If our competitors develop products superior to ours, market their products more effectively than we market our products, or
receive regulatory approval before our products, our commercial opportunities could be reduced or eliminated.
We expect our products will continue to encounter significant competition. The INTERCEPT Blood System products compete with
other approaches to blood safety currently in use and may compete with future products that may be developed by others. Our success
will depend in part on our ability to respond quickly to customer and prospective customer needs, successfully receive and maintain
regulatory approvals, and adapt to medical and technological changes brought about by the development and introduction of new
products. Competitors’ products or technologies may make our products obsolete or non-competitive before we are able to generate
any significant revenue. In addition, competitors or potential competitors may have substantially greater financial and other resources
than we have. They may also have greater experience in preclinical testing, human clinical trials and other regulatory approval
procedures. If competitors’ products experience significant problems, customers and potential customers may question the safety and
efficacy of all pathogen reduction technologies, including the INTERCEPT Blood System. Such questions and concerns may impair
our ability to market and sell the INTERCEPT Blood System.
Several companies have, or are developing, technologies that are, or in the future may be, the basis for products that will directly
compete with or reduce the market for our pathogen reduction systems. A number of companies are specifically focusing on
alternative strategies for pathogen reduction in platelets and plasma.
These alternative strategies may be more effective in reducing certain types of pathogens from blood products, including certain non-
lipid-enveloped viruses, such as hepatitis A and E viruses, which our products have not demonstrated an ability to inactivate, or
human parvovirus B-19, which is also a non-lipid-enveloped virus, for which our products have not demonstrated a high level of
inactivation. While studies have demonstrated that our products can effectively inactivate a broad spectrum of pathogens in blood
components, market adoption of our products may be reduced if customers determine that competitors’ products inactivate a broader
range of pathogens that are of particular interest to the transfusion medicine community. In addition, customers and prospective
customers may believe that our competitors’ products are safer, more cost effective or easier to implement and incorporate into
existing blood processing procedures than INTERCEPT Blood System products. In Europe, several companies, including Grifols
S.A., Octapharma AG, MacoPharma International and Kedrion Biopharma, are developing or selling commercial pathogen reduction
systems or services to treat fresh frozen plasma.
MacoPharma has received CE Mark for a UVC-based product for pathogen reduced platelets. MacoPharma currently has a Phase III
clinical trial underway in Germany to generate additional data for expanded approval. In addition, Terumo BCT, a subsidiary of
Terumo Corporation, has developed a pathogen reduction system for blood products and has been issued CE marks for its system for
both platelets and plasma. We further understand that Terumo BCT developed a pathogen reduction system for whole blood and has
recently completed a clinical trial of its whole blood system in Ghana, receiving a class II CE mark. Terumo’s products may offer
competitive advantages over our INTERCEPT Blood System. Terumo Corporation is a large Japanese-based, multinational
corporation with more mature products and relationships than we have. Our ability to commercialize our products in certain markets,
particularly in Japan, may be negatively affected by Terumo’s resources and their pre-existing relationships with regulators and
customers. Should Terumo BCT’s product be approved for use and commercialized in Japan, our products would likely directly
compete with their products and we believe we would likely either need to establish operations in Japan or partner with a local
Japanese company.
Octapharma AG received FDA approval in January 2013 to sell treated fresh frozen plasma for certain indications and is currently
commercially available. Should Octapharma enter into exclusive agreements with key customers, our plasma system may encounter
market resistance and we will have a more limited market into which we can sell.
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In addition, we understand that Octapharma received approval to sell fresh frozen plasma in France. Octapharma’s entry into the
French market may pose a competitive threat to other pathogen reduced plasmas, including INTERCEPT and may in turn limit the
potential market available to us in France.
Other companies developing competing products may also offer and sell other blood-banking products and services. As a result,
competitors may have pre-existing long-term relationships with customers and may be able to offer synergies for both pathogen
reduction and non-pathogen reduction products that we are unable to offer. Regulatory agencies may mandate use of competing
products which would limit our ability to sell our products in those markets.
New methods of testing whole blood for specific pathogens have been approved by the FDA and in Europe, as have tests for bacteria
in platelets. Other companies are marketing rapid, point-of-care bacterial tests, and developing synthetic blood product substitutes and
products to stimulate the growth of platelets. Development and commercialization of any of these or other related technologies could
limit the potential market for our products as would a mandate of any competing technology other than INTERCEPT.
We may be liable and we may need to withdraw our products from the market if our products harm people. We may be liable if an
accident occurs in our controlled use of hazardous materials. Our insurance coverage may be inadequate to offset losses we may
incur.
We are exposed to potential liability risks inherent in the testing and marketing of medical devices. We may be liable if any of our
products cause injury, illness or death. Although we will have completed preclinical and clinical safety testing prior to marketing our
products, there may be harmful effects caused by our products that we are unable to identify in preclinical or clinical testing. In
particular, unforeseen, rare reactions or adverse side effects related to long-term use of our products may not be observed until the
products are in widespread commercial use. Because of the limited duration and number of patients receiving blood components
treated with the INTERCEPT Blood System products in clinical trials, it is possible that harmful effects of our products not observed
in preclinical and clinical testing could be discovered after a marketing approval has been received. For example, in cases where we
have obtained regulatory approval for our products, we have demonstrated pathogen reduction to specified levels based on well-
established tests. However, there is no way to determine, after treatment by our products, whether our products have completely
inactivated all of the pathogens that may be present in blood components. There is also no way to determine whether any residual
amount of a pathogen remains in the blood component treated by our products and there is no way to exclude that such residual
amount would be enough to cause disease in the transfused patient or was a result of a potential defect or lack of efficacy of our
products. For ethical reasons, we cannot conduct human testing to determine whether an individual who receives a transfusion of a
blood component containing a pathogen that was inactivated using the INTERCEPT Blood System might show positive results if
tested for an antibody against that pathogen. While we believe, based on the clinical experience of our scientists, that the level of
inactivated pathogens would likely be too small to induce a detectable antibody response in diagnostic tests, we cannot exclude that a
transfused patient might show positive results if tested for an antibody against that pathogen. We could be subject to a claim from a
patient that tests positive, even though that patient did not contract a disease. In addition, should personnel at clinical study sites or
ultimately, potential customers, be harmed by amustaline, or believe they have been or could be harmed by amustaline, our insurance
coverage may be insufficient to provide coverage for any related potential liabilities. Amustaline is considered a potent chemical and
is the active compound of our red blood cell system.
We maintain product liability insurance, but do not know whether the insurance will provide adequate coverage against potential
liabilities. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be
required to limit commercialization of our products.
Our research and development activities involve the controlled use of hazardous materials, including certain hazardous chemicals,
radioactive materials and infectious pathogens, such as HIV and hepatitis viruses. Although we believe that our safety procedures for
handling and disposing of hazardous materials are adequate and comply with regulatory requirements, we cannot eliminate the risk of
accidental contamination or injury. If an accident occurs, we could be held liable for any damages that result.
A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of
serious safety issues with our products that leads to corrective actions, could have a significant adverse impact on us.
The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event
of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to
health. The FDA’s authority to require a recall must be based on an FDA finding that there is reasonable probability that the device
would cause serious injury or death. Manufacturers may also, under their own initiative, recall a product if any material deficiency in a
device is found or withdraw a product to improve device performance or for other reasons. The FDA requires that certain
classifications of recalls be reported to the FDA within ten working days after the recall is initiated. A government-mandated or
voluntary recall by us or one of our distributors could occur as a result of an unacceptable risk to health, component failures,
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malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues. Regulatory agencies in other countries
have similar authority to recall devices because of material deficiencies or defects in design or manufacture that could endanger
health. Any recall would divert management attention and financial resources and could cause the price of our stock to decline, expose
us to product liability or other claims and harm our reputation with customers. Such events could impair our ability to supply our
products in a cost-effective and timely manner in order to meet our customers’ demands. Companies are required to maintain certain
records of recalls, even if they are not reportable to the FDA or similar foreign governmental authorities. We may initiate voluntary
recalls involving our products in the future that we determine do not require notification of the FDA or foreign governmental
authorities. If the FDA or foreign governmental authorities disagree with our determinations, they could require us to report those
actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition,
the FDA or a foreign governmental authority could take enforcement action for failing to report the recalls when they were conducted.
In addition, under the FDA’s medical device reporting regulations, we are required to report to the FDA any incident in which our
products may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction
were to recur, would likely cause or contribute to death or serious injury. Repeated product malfunctions may result in a voluntary or
involuntary product recall. We are also required to follow detailed recordkeeping requirements for all firm-initiated medical device
corrections and removals, and to report such corrective and removal actions to FDA if they are carried out in response to a risk to
health and have not otherwise been reported under the medical device reporting regulations. If we do not adequately address problems
associated with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure,
injunctions, administrative penalties, or civil or criminal fines. We may also be required to bear other costs or take other actions that
may have a negative impact on our sales as well as face significant adverse publicity or regulatory consequences, which could harm
our business, including our ability to market our products in the future.
Any adverse event involving our products, whether in the U.S. or abroad could result in future voluntary corrective actions, such as
recalls or customer notifications, or agency action, such as inspection, mandatory recall or other enforcement action. Any corrective
action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and
capital, distract management from operating our business and may harm our reputation and financial results.
If we fail to obtain the capital necessary to fund our future operations or if we are unable to generate positive cash flows from our
operations, we will need to curtail planned development or sales and commercialization activities.
Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments
associated with commercializing the INTERCEPT Blood System, including in connection with the continuing U.S. commercial launch
of our platelet and plasma systems, commitments to fund projects with Fresenius, costs to develop different configurations of existing
products and new products, including our illuminator, costs associated with planning, enrolling and completing ongoing studies, and
the post-approval studies we are required to conduct in connection with the FDA approval of the platelet system, costs associated with
pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs
associated with conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., including our
ongoing European Phase III clinical trial of our red blood cell system for chronic anemia patients, costs associated with performing the
agreed-upon activities under our BARDA agreement, and costs related to creating, maintaining and defending our intellectual
property. Our long-term capital requirements will also be dependent on the success of our sales efforts, competitive developments, the
timing, costs and magnitude of our longer-term clinical trials and other development activities related to our platelet, plasma and red
blood cell systems, including required post-approval studies for the platelet system, market preparedness and product launch activities
for any of our products in geographies where we do not currently sell our products, and regulatory factors. Until we are able to
generate a sufficient amount of product revenue and generate positive net cash flows from operations, which we may never do,
meeting our long-term capital requirements is in large part reliant on continued access to funds under our BARDA agreement and the
public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash
generated from operations and interest income earned on the investment of our cash balances. We believe that our available cash and
cash equivalents and short-term investments, as well as cash received from product sales and under our agreement with BARDA, will
be sufficient to meet our capital requirements for at least the next twelve months. We have based our cash sufficiency estimate on
assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, we could consume our available capital
resources sooner than we currently expect or in excess of amounts than we currently expect, which could adversely affect our
commercialization and clinical development activities.
We have borrowed and in the future may borrow additional capital from institutional and commercial banking sources to fund future
growth, including pursuant to our loan and security agreement with Oxford Finance, as described below, or potentially pursuant to
new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants
that restrict the operation of our business, liens on assets, high effective interest rates and repayment provisions that reduce cash
resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to the equity
capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity
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securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or
partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our
products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive
to our stockholders.
While we expect to receive significant funding under our five-year agreement with BARDA, our ability to obtain the funding we
expect to receive under the agreement is subject to various risks and uncertainties, including with respect to BARDA’s ability to
terminate the agreement for convenience at any time. In addition, access to federal contracts is subject to the authorization of funds
and approval of our research plans by various organizations within the federal government, including the U.S. Congress. The general
economic environment, coupled with tight federal budgets, has led to a general decline in the amount available for government
funding. If BARDA were to eliminate, reduce or delay funding under our agreement, this would have a significant negative impact on
the programs associated with such funding and could have a significant negative impact on our revenues and cash flows. In addition, if
we are unable to reach agreement with the FDA on a license-enabling Phase III clinical trial design for our red blood cell system, our
agreement with BARDA will be severely limited in scope or could be terminated altogether, and our ability to complete the
development activities required for licensure in the U.S. may require additional capital beyond which we currently have. If alternative
sources of funding are not available, we may be forced to suspend or terminate development activities related to the red blood cell
system in the U.S.
As a result of economic conditions, general global economic uncertainty, political change, and other factors, we do not know whether
additional capital will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms.
If we are unable to raise additional capital due to the volatile global financial markets, general economic uncertainty or other factors,
we may need to curtail planned development or commercialization activities. In addition, we may need to obtain additional funds to
complete development activities for the red blood cell system necessary for potential regulatory approval in Europe, if costs are higher
than anticipated or we encounter delays. We may need to obtain additional funding to conduct additional randomized controlled
clinical trials for existing or new products, particularly if we are unable to access the any portion of the funding contemplated by our
BARDA agreement, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our
existing operations provide sufficient cash flow to conduct these trials.
Covenants in our loan and security agreement restrict our business and operations in many ways and if we do not effectively
manage our covenants, our financial conditions and results of operations could be adversely affected. In addition, our operations
may not provide sufficient cash to meet the repayment obligations of our debt incurred under the loan and security agreement.
Our loan and security agreement with Oxford Finance provided $20.0 million of term loan funds, due, June 1, 2019. All of our current
and future assets, except for intellectual property and 35% of our investment in our subsidiary, Cerus Europe B.V., are secured for our
borrowings under the loan and security agreement. The loan and security agreement requires that we comply with certain covenants
applicable to us and our subsidiary, including among other things, covenants restricting dispositions, changes in business,
management, ownership or business locations, mergers or acquisitions, indebtedness, encumbrances, distributions, investments,
transactions with affiliates and subordinated debt, any of which could restrict our business and operations, particularly our ability to
respond to changes in our business or to take specified actions to take advantage of certain business opportunities that may be
presented to us. Our failure to comply with any of the covenants could result in a default under the loan and security agreement, which
could permit the lenders to declare all or part of any outstanding borrowings to be immediately due and payable, or to refuse to permit
additional borrowings under the loan and security agreement. If we are unable to repay those amounts, the lenders under the loan and
security agreement could proceed against the collateral granted to them to secure that debt, which would seriously harm our business.
In addition, should we be unable to comply with these covenants or if we default on any portion of our outstanding borrowings, the
lenders can also impose a 5% penalty and restrict access to additional borrowings under the loan and security agreement.
Virtually all of our research and development activities and the significant majority of our general and administrative activities are
performed in or managed from a single site that may be subject to lengthy business interruption in the event of a severe
earthquake. We also may suffer loss of computerized information and may be unable to make timely filings with regulatory
agencies in the event of catastrophic failure of our data storage and backup systems.
Virtually all of our research and development activities and the significant portion of our general and administrative activities are
performed in or managed from our facilities in Concord, California, which are within an active earthquake fault zone. Should a severe
earthquake occur, we might be unable to occupy our facilities or conduct research and development and general and administrative
activities in support of our business and products until such time as our facilities could be repaired and made operational. Our property
and casualty and business interruption insurance in general does not cover losses caused by earthquakes. While we have taken certain
measures to protect our scientific, technological and commercial assets, a lengthy or costly disruption due to an earthquake would
have a material adverse effect on us. We have also taken measures to limit damage that may occur from the loss of computerized data
due to power outage, system or component failure or corruption of data files. However, we may lose critical computerized data, which
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may be difficult or impossible to recreate, which may harm our business. We may be unable to make timely filings with regulatory
agencies in the event of catastrophic failure of our data storage and backup systems, which may subject us to fines or adverse
consequences, up to and including loss of our ability to conduct business.
If we fail to attract, retain and motivate key personnel or to retain the members of our executive management team, our operations
and our future growth may be adversely affected.
We are highly dependent upon our executive management team and other critical personnel, including our specialized research and
development, regulatory and operations personnel, many of whom have been employed with us for many years and have a significant
amount of institutional knowledge about us and our products. We do not carry “key person” insurance. If one or more members of our
executive management team or other key personnel were to retire or resign, our ability to achieve development, regulatory or
operational milestones for commercialization of our products could be adversely affected if we are unable to replace them with
employees of comparable knowledge and experience. In addition, we may not be able to retain or recruit other qualified individuals,
and our efforts at knowledge transfer could be inadequate. If knowledge transfer, recruiting and retention efforts are inadequate,
significant amounts of internal historical knowledge and expertise could become unavailable to us.
We also rely on our ability to attract, retain and motivate skilled and highly qualified personnel in order to grow our company.
Competition for qualified personnel in the medical device and pharmaceutical industry is very intense. If we are unable to attract,
retain and motivate quality individuals, our business, financial condition, ability to perform under our BARDA agreement, or results
of operations and growth prospects could be adversely affected. Even if we are able to identify and hire qualified personnel
commensurate with our growth objectives and opportunities, the process of integrating new employees is time consuming, costly and
distracting to existing employees and management. Such disruptions may have an adverse impact on our operations, our ability to
service existing markets and customers, or our ability to comply with regulations and laws.
All of the employees of our subsidiary, Cerus Europe B.V., are employed outside the U.S., including in France, where labor and
employment laws are relatively stringent and, in many cases, grant significant job protection to certain employees, including rights on
termination of employment. In addition, one of our manufacturing partners that we are dependent on is located in France and may
have employees that are members of unions or represented by a works council as required by law. These more stringent labor and
employment laws to the extent that they are applicable, coupled with the requirement to consult with the relevant unions or works’
councils, could increase our operational costs with respect to our own employees and could result in passed through operational costs
by our manufacturing partner. If the increased operational costs become significant, our business, financial condition and results of
operations could be adversely impacted.
Significant disruptions of information technology systems or breaches of data security could adversely affect our business.
Our business is increasingly dependent on complex and interdependent information technology systems, including internet-based
systems, databases and programs, to support our business processes as well as internal and external communications. These computer
systems are potentially vulnerable to breakdown, malicious intrusion and computer viruses which may result in the impairment of
production and key business processes or loss of data or information. Additionally, our systems are potentially vulnerable to data
security breaches—whether by employees or others—which may expose sensitive data to unauthorized persons. Such data security
breaches could lead to the loss of trade secrets or other intellectual property, or could lead to the public exposure of personal
information (including sensitive personal information) of our employees, clinical trial patients, distributors, customers and others.
Such disruptions and breaches of security could have a material adverse effect on our business, financial condition and results of
operations.
In addition, our enterprise resource planning system, or ERP System, is extremely complex and impacts a significant number of our
business processes. Should we experience unforeseen difficulties with our ERP System, we may experience disruptions to our
operations, increased costs in troubleshooting and resolving the issues, and erosion in confidence from customers and employees, any
of which could have a material adverse effect on our business and operations.
Our ability to use our net operating loss carryforwards and certain other tax attributes is uncertain and may be limited.
Our ability to use our federal and state net operating loss, or NOL, carryforwards to offset potential future taxable income and related
income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the
NOL carryforwards, and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of
our NOL carryforwards. In addition, utilization of NOL carryforwards to offset potential future taxable income and related income
taxes that would otherwise be due is subject to annual limitations under the “ownership change” provisions of Sections 382 of the
Internal Revenue Code of 1986, as amended, or the Code, and similar state provisions, which may result in the expiration of NOL
carryforwards before future utilization. In general, under the Code, if a corporation undergoes an “ownership change,” generally
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defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its
pre-change NOL carryforwards and other pre-change tax attributes (such as research and development credit carryforwards) to offset
its post-change taxable income or taxes may be limited. Our equity offerings and other changes in our stock ownership, some of which
are outside of our control, may have resulted or could in the future result in an ownership change. Although we have completed
studies to provide reasonable assurance that an ownership change limitation would not apply, we cannot be certain that a taxing
authority would reach the same conclusion. If, after a review or audit, an ownership change limitation were to apply, utilization of our
domestic NOL and tax credit carryforwards could be limited in future periods and a portion of the carryforwards could expire before
being available to reduce future income tax liabilities.
We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of
others.
Our commercial success will depend, in part, on obtaining and maintaining patent protection on our products and successfully
defending our products against third-party challenges. Our technology will be protected from unauthorized use only to the extent that
it is covered by valid and enforceable patents or effectively maintained as trade secrets. As a result, our success depends in part on our
ability to:
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obtain patents;
protect trade secrets;
operate without infringing upon the proprietary rights of others; and
prevent others from infringing on our proprietary rights.
We cannot be certain that our patents or patents that we license from others will be enforceable and afford protection against
competitors. Our patents or patent applications, if issued, may be challenged, invalidated or circumvented. Our patent rights may not
provide us with proprietary protection or competitive advantages against competitors with similar technologies. Others may
independently develop technologies similar to ours or independently duplicate our technologies. For example, we are aware of a U.S.
patent issued to a third-party that covers methods to remove psoralen compounds from blood products. We have reviewed the patent
and believe there exist substantial questions concerning its validity. We cannot be certain, however, that a court would hold the patent
to be invalid or not infringed by our platelet or plasma systems. In this regard, whether or not we infringe this patent will not be
known with certainty unless and until a court interprets the patent in the context of litigation. In the event that we are found to infringe
any valid claim of this patent, we may, among other things, be required to pay damages, cease the use and sale of our platelet and
plasma systems and/or obtain a license from the owner of the patent, which we may not be able to do at a reasonable cost or at all. Our
patents expire at various dates between now and 2031. Recent patent applications will, if granted, result in patents with later expiration
dates. In addition, we have a license from Fresenius to U.S. and foreign patents relating to the INTERCEPT Blood System, which
expire at various dates between 2018 and 2024. Due to the extensive time required for development, testing and regulatory review of
our potential products, our patents may expire or remain in existence for only a short period following commercialization. This would
reduce or eliminate any advantage of the patents.
We cannot be certain that we were the first to make the inventions covered by each of our issued patents or pending patent
applications or that we were the first to file patent applications for such inventions. We may need to license the right to use third-party
patents and intellectual property to continue development and commercialization of our products, including in connection with our
planned commercialization of the platelet and plasma systems in the U.S. We may not be able to acquire such required licenses on
acceptable terms, if at all. If we do not obtain such licenses, we may need to design around other parties’ patents, or we may not be
able to proceed with the development, manufacture or sale of our products.
Our patents do not cover all of the countries in which we are selling, and planning to sell, our products. We will not be able to prevent
potential competitors from using our technology in countries where we do not have patent coverage. Further, the laws of some foreign
countries may not protect intellectual property rights to the same extent as the laws of the U.S., including the CIS countries, China and
India, jurisdictions where we are currently expanding our commercialization efforts through distributors. In certain countries,
compulsory licensing laws exist that may be used to compel a patent owner to grant licenses to third parties, for reasons such as non-
use of the patented subject matter within a certain period of time after patent grant or commercializing in a manner that is cost-
prohibitive in the country. In those countries, we may have limited remedies if our patents are infringed or if we are compelled to
grant a license for INTERCEPT to a third party, which could materially diminish the value of such patents. This could adversely
impact our potential revenue opportunities.
We may face litigation requiring us to defend against claims of infringement, assert claims of infringement, enforce our patents,
protect our trade secrets or know-how or determine the scope and validity of others’ proprietary rights. Patent litigation is costly. In
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addition, we may require interference proceedings before the U.S. Patent and Trademark Office to determine the priority of inventions
relating to our patent applications. Litigation or interference proceedings could be expensive and time consuming, and we could be
unsuccessful in our efforts to enforce our intellectual property rights. We may rely, in certain circumstances, on trade secrets to protect
our technology. However, trade secrets are difficult to protect. We protect our proprietary technology and processes, in part, by
confidentiality agreements with employees, consultants and contractors. These agreements may be breached and we may not have
adequate remedies for any breach or our trade secrets may otherwise become known or be independently discovered by competitors.
To the extent that our employees, consultants or contractors use intellectual property owned by others, disputes also may arise as to
the rights in related or resulting know-how and inventions.
As our international operations grow, we may be subject to adverse fluctuations in exchange rates between the U.S. dollar and
foreign currencies, tariffs and other trade restrictions.
Our international operations are subject to risks typical of an international business, including, among other factors: differing political,
economic, and regulatory climates, different tax structures and foreign exchange volatility. We do not currently enter into any hedging
contracts to normalize the impact of foreign exchange fluctuations. As a result, our future results could be materially affected by
changes in these or other factors.
Product sales of the INTERCEPT Blood System sold outside of the U.S. are typically invoiced to customers in Euros. In addition, we
purchase finished INTERCEPT disposable kits for our platelet and plasma systems and incur certain operating expenses in Euros and
other foreign currencies. Our exposure to foreign exchange rate volatility is a direct result of our product sales, cash collection and
cash payments for expenses to support our international operations. Foreign exchange rate fluctuations are recorded as a component of
other income, net on our consolidated statements of operations. Significant fluctuations in the volatility of foreign currencies relative
to the U.S. dollar may materially affect our results of operations. For example, the announcement of Brexit caused severe volatility in
global currency exchange rate fluctuations that resulted in the strengthening of the U.S. dollar against foreign currencies in which we
transact business, and should this foreign exchange volatility continue, it could cause volatility in our results of operations. In addition,
in a period where the U.S. dollar is strengthening/weakening as compared to Euros and other currencies we transact in, our revenues
and expenses denominated in Euros or other foreign currencies are translated into U.S. dollars at a lower/higher value than they would
be in an otherwise constant currency exchange rate environment.
Currently we do not have a formal hedging program to mitigate the effects of foreign currency volatility. As our commercial
operations grow globally, our operations are exposed to more currencies and as a result our exposure to foreign exchange risk will
grow.
Additionally, the Trump administration has called for substantial changes to foreign trade policy and has raised the possibility of
imposing significant increases in tariffs on international trade. We also rely on various U.S. corporate tax provisions related to
international commerce. If we are subject to new regulations, or if restrictions and tariffs increase our operating costs in the future, and
we are not able to recapture those costs from our customers, or if such initiatives, regulations, restrictions or tariffs make it more
difficult for us to compete in overseas markets, our business, financial condition and results of operations could be adversely
impacted.
We currently have a limited trading volume, which results in higher price volatility for, and reduced liquidity of, our common
stock.
Our shares of common stock are currently quoted on the Nasdaq Global Market under the symbol “CERS.” The market for our
common stock has been limited due to low trading volume and the small number of brokerage firms acting as market makers. Active
trading markets generally result in lower price volatility and more efficient execution of buy and sell orders. The absence of an active
trading market increases price volatility and reduces the liquidity of our common stock. As long as this condition continues, the sale of
a significant number of shares of common stock at any particular time could be difficult to achieve at the market prices prevailing
immediately before such shares are offered, which may limit our ability to effectively raise money. In addition, due to the limitations
of our market and the volatility in the market price of our stock, investors may face difficulties in selling shares at attractive prices
when they want to sell. As a result of this lack of trading activity, the quoted price for our common stock is not necessarily a reliable
indicator of its fair market value.
We are obligated to develop and maintain proper and effective internal control over financial reporting. In the future, we may not
complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be
determined to be effective, which may adversely affect investor confidence in our company and, as a result, the value of our
common stock.
We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the
effectiveness of our internal control over financial reporting. This assessment includes disclosure of any material weakness identified
44
by our management in our internal control over financial reporting, as well as a statement that our independent registered public
accounting firm has issued an attestation report on the effectiveness of our internal control over financial reporting.
Complying with Section 404 requires a rigorous compliance program as well as adequate time and resources. As a result of expanding
our commercialization efforts, developing, improving and expanding our core information technology systems as well as
implementing new systems to support our sales, supply chain activities and reporting capabilities, all of which require significant
management time and support, we may not be able to complete our internal control evaluation, testing and any required remediation in
a timely fashion. Additionally, if we identify one or more material weaknesses in our internal control over financial reporting, we will
not be unable to assert that our internal controls are effective. For example, our management concluded that our internal control over
financial reporting was ineffective as of December 31, 2014, because material weaknesses existed in our internal control over financial
reporting related to the valuation of our inventory and cost of product revenue and the timeliness and accuracy of recording
adjustments to certain accrued liabilities as reported on our consolidated balance sheets and statements of operations. Although we
have been able to successfully remediate those internal control deficiencies, to the extent we identify future weaknesses or
deficiencies, there could be material misstatements in our consolidated financial statements and we could fail to meet our financial
reporting obligations. As a result, our ability to obtain additional financing, or obtain additional financing on favorable terms, could be
materially and adversely affected which, in turn, could materially and adversely affect our business, our financial condition and the
value of our common stock. If we are unable to assert that our internal control over financial reporting is effective in the future, or if
our independent registered public accounting firm is unable to express an opinion or expresses an adverse opinion on the effectiveness
of our internal controls in the future, investor confidence in the accuracy and completeness of our financial reports could be further
eroded, which would have a material adverse effect on the price of our common stock.
Provisions of our charter documents, our stockholder rights plan, our compensatory arrangements and Delaware law could make
it more difficult for a third party to acquire us, even if the offer may be considered beneficial by our stockholders.
Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or
prevent a change in control. The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to
the ability of a third party to acquire control of us, even if a change in control would be beneficial to our existing stockholders. In
addition, Section 203 of the Delaware General Corporation Law, unless its application has been waived, provides certain default anti-
takeover protections in connection with transactions between us and an “interested stockholder”. Generally, Section 203 prohibits
stockholders who, alone or together with their affiliates and associates, own more than 15% of the subject company from engaging in
certain business combinations for a period of three years following the date that the stockholder became an interested stockholder of
such subject company without approval of the board or the vote of two-thirds of the shares held by the independent stockholders. Our
board of directors has also adopted a stockholder rights plan, or “poison pill,” which would significantly dilute the ownership of a
hostile acquirer. Additionally, provisions of our amended and restated certificate of incorporation and bylaws could deter, delay or
prevent a third party from acquiring us, even if doing so would benefit our stockholders, including without limitation, the authority of
the board of directors to issue, without stockholder approval, preferred stock with such terms as the board of directors may determine.
In addition, our executive employment agreements, change of control severance benefit plan and equity incentive plans and
agreements thereunder provide for certain severance benefits in connection with a change of control of us, including single-trigger
equity vesting acceleration benefits with respect to outstanding stock options, which could increase the costs to a third party acquirer
and/or deter such third party from acquiring us.
Item 1B. Unresolved Staff Comments
None.
45
Item 2.
Properties
Our corporate headquarters, which includes our principal executive offices, is located in Concord, California. This leased facility
includes laboratory space for blood safety research and supports general administrative, marketing and technical support functions.
We also lease a facility in Amersfoort, the Netherlands, which is used for selling and administrative functions. We believe that our
current facilities will be adequate for the foreseeable future. The following table summarizes the properties we lease and their location,
size, term and primary functions as of December 31, 2016.
Square
Footage
Lease Expiration
Date
Locations
Concord, CA, United States .......... 36,029 November 2019
7,702 September 2019
Concord, CA, United States ..........
Concord, CA, United States ..........
6,655 December 2017
Concord, CA, United States .......... 21,440 July 2017
Amersfoort, Netherlands ...............
7,300 January 2018
Primary Functions
Administrative and research
Administrative and warehouse
Administrative and research
Sales, administrative, marketing and technical support
Sales and administrative
Item 3.
Legal Proceedings
None.
Item 4. Mine Safety Disclosures
Not applicable.
46
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Our common stock is traded on the Nasdaq Global Market under the symbol “CERS.” The following table sets forth, for the periods
indicated, the high and low intra-day sales prices for our common stock as reported by the Nasdaq Global Market:
Year Ended December 31, 2016:
First Quarter ......................................................................... $
Second Quarter .....................................................................
Third Quarter ........................................................................
Fourth Quarter ......................................................................
Year Ended December 31, 2015:
First Quarter ......................................................................... $
Second Quarter .....................................................................
Third Quarter ........................................................................
Fourth Quarter ......................................................................
High
Low
6.66 $
6.89
7.64
6.34
7.03 $
5.70
5.87
6.60
4.81
4.90
5.79
4.17
3.95
3.82
4.29
4.27
On February 24, 2017, the last reported sale price of our common stock on the Nasdaq Global Market was $4.27 per share. On
February 24, 2017, we had approximately 137 holders of record of our common stock.
Dividends
We have not declared or paid dividends on our common stock and do not intend to pay cash dividends on our common stock in the
foreseeable future. Additionally, any cash dividends declared or paid would require prior written consent under the terms of the loan
and security agreement entered on June 30, 2014, with Oxford Finance LLC.
47
Stock Performance Graph (1)
The following graph shows the total stockholder return of an investment of $100 in cash (and the reinvestment of any dividends
thereafter) on December 31, 2011, and tracked the performance through December 31, 2016, for (i) our common stock, (ii) the NASDAQ
Biotechnology Index, (iii) the NYSE ARCA Biotechnology Index, and (iv) the NASDAQ Stock Market (United States) Index. Our stock
price performance shown in the graph below is based upon historical data and is not indicative of future stock price performance.
Comparison of 5-year Cumulative Total Return on Investment
400
300
200
100
2011
2012
2013
2014
2015
2016
Cerus(cid:3)Corp
NASDAQ(cid:3)Biotech(cid:3)Index
NYSE(cid:3)ARCA(cid:3)Biotech(cid:3)Index
NASDAQ
2011
2012
2013
2014
2015
2016
Cerus Corporation ....................... $
NASDAQ Biotech Index ............
NYSE ARCA Biotech Index .......
NASDAQ ....................................
100.00 $
100.00
100.00
100.00
112.86 $
131.91
141.74
115.91
230.36 $
218.45
213.52
160.32
222.86 $
292.93
315.10
181.80
225.71 $
326.39
349.45
192.21
155.36
255.62
281.74
206.63
December 31,
(1) The graph and the other information furnished in this section is not “soliciting material,” is not deemed “filed” with the SEC and
is not to be incorporated by references to any filing of Cerus Corporation under the Securities Act of 1933 or the Securities Act
of 1934, whether made before or after the date hereof and irrespective of any general incorporation language in such filing.
48
Item 6.
Selected Financial Data
The following table summarizes certain selected financial data for the five years ended December 31, 2016, which has been derived
from audited consolidated financial statements. The information presented below may not be indicative of future results and should be
read in conjunction with “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and the
consolidated financial statements and notes thereto included elsewhere in this Annual Report on Form 10-K.
(in thousands, except per share amounts)
Consolidated Statements of Operations Data:
2016
Year Ended December 31,
2014
2013
2015
Product revenue ............................................................... $
Cost of product revenue ...................................................
Gross profit on product revenue .................................
Government contracts revenue ..............................................
Loss from operations .............................................................
Net loss .................................................................................
37,183 $
20,295
16,888
2,092
(61,447)
(62,906)
34,223 $
23,464
10,759
—
(61,075)
(55,868)
36,416 $
21,188
15,228
—
(44,503 )
(38,755 )
39,657 $
22,602
17,055
—
(28,299)
(43,337)
2012
36,695
20,616
16,079
91
(17,300)
(15,917)
Net loss per share:
Basic ................................................................................ $
Diluted ............................................................................. $
(0.62) $
(0.62) $
(0.58) $
(0.61) $
(0.52 ) $
(0.61 ) $
(0.64) $
(0.64) $
(0.29)
(0.33)
Weighted average shares outstanding used for calculating
loss per share:
Basic ................................................................................
Diluted .............................................................................
101,826
101,826
96,068
96,905
74,767
76,534
67,569
67,569
54,515
55,061
(in thousands)
Consolidated Balance Sheets Data:
Cash, cash equivalents, short-term investments and
investment in marketable equity securities ........................ $
Working capital (1) ..................................................................................................
Total assets (1) ............................................................................................................
Long-term obligations (1) ...................................................................................
Total stockholders' equity .....................................................
2016
2015
December 31,
2014
2013
2012
71,628 $
67,217
103,476
18,801
57,787
107,879 $
108,544
139,402
22,775
94,765
51,294 $
45,736
81,669
10,998
41,521
57,676 $
38,730
83,381
1,162
42,795
26,696
18,383
48,919
4,199
19,107
(1) Amounts as of December 31, 2015 and 2014, have been recast to reflect the adoption of ASU 2015-03, Interest - Imputation of
Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs in 2016, as further described in Note 2.
Summary of Significant Accounting Policies included herein. The Company has adopted this ASU effective January 1, 2016,
under the retrospective application method. To conform to the current period presentation, the Company reclassified $32,000
and $36,000, which were previously included in Working capital and Total assets, respectively, in the Company's condensed
consolidated balance sheet as of December 31, 2015, as a reduction of Long-term obligations. The Company also reclassified
$37,000 and $70,000, which were previously included in Total assets in the Company's condensed consolidated balance sheet as
of December 31, 2014, as a reduction of Working capital and Long-term obligations, respectively.
49
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This discussion and analysis should be read in conjunction with our audited consolidated financial statements and the accompanying
notes thereto included in this Annual Report on Form 10-K for the year ended December 31, 2016. Operating results for the year
ended December 31, 2016, are not necessarily indicative of results that may occur in future periods.
Overview
Since our inception in 1991, we have devoted substantially all of our efforts and resources to the research, development, clinical
testing and commercialization of the INTERCEPT Blood System. The INTERCEPT Blood System is designed for three blood
components: platelets, plasma and red blood cells. The INTERCEPT Blood System for platelets, or platelet system, and the
INTERCEPT Blood System for plasma, or plasma system, have received CE marks and FDA approval and are being marketed and
sold in a number of countries around the world.
The platelet system is approved in the U.S. for ex vivo preparation of pathogen-reduced apheresis platelet components in order to
reduce the risk of transfusion-transmitted infection, or TTI, including sepsis, and to potentially reduce the risk of transfusion-
associated graft versus host disease or TA-GVHD. The plasma system is approved in the U.S. for ex vivo preparation of plasma in
order to reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion.
The INTERCEPT Blood System for red blood cells, or the red blood cell system, is currently in development and has not been
commercialized anywhere in the world. We completed our European Phase III clinical trial of our red blood cell system for acute
anemia patients and have another ongoing European Phase III clinical trial of our red blood cell system for chronic anemia patients.
Although we plan to complete additional development activities to support an anticipated CE mark submission for the red blood cell
system, such development activities, including any additional studies that may be required by the FDA prior to its review of any
proposed U.S. Phase III clinical trial protocol, could prolong development of our red blood cell system, and we do not expect to
receive any regulatory approvals of our red blood cell system in the next twelve months, if ever. We understand that while the acute
anemia Phase III clinical trial in Europe may be sufficient to receive CE mark approval in Europe, we may need to generate additional
safety data from commercial use and/or achieve a successful outcome in the ongoing chronic anemia Phase III clinical trial of our red
blood cell system in order to achieve broad market acceptance. In addition, these trials may need to be supplemented by additional,
successful Phase III clinical trials for approval in certain countries. If such additional Phase III clinical trials are required, they would
likely need to demonstrate equivalency of INTERCEPT-treated red blood cells compared to conventional red blood cells and
significantly lower lifespan for INTERCEPT-treated red blood cells compared to non-treated red blood cells may limit our ability to
obtain any regulatory approvals for the red blood cell system. As part of our development activities, we will need to successfully
complete a number of in vitro studies prior to receiving any regulatory approvals in Europe and we will need to successfully complete
additional activities, including a license-enabling Phase III clinical trial in the U.S., prior to receiving any regulatory approvals in the
U.S. Successful completion of these activities may require capital beyond that which we currently have or that may be available to us
under our agreement with the Biomedical Advanced Research and Development Authority, or BARDA, and we may be required to
obtain additional capital in order to complete the development of and obtain any regulatory approvals for the red blood cell system. If
we experience delays in testing, conducting trials or obtaining approvals, our product development costs will increase.
In 2016, we entered into a five-year agreement with BARDA, part of the U.S. Department of Health and Human Services’ Office of
the Assistant Secretary for Preparedness and Response, to receive funding of up to $41.6 million with a total funding opportunity of
up to $185.0 million to support the development of our red blood cell system, including clinical and regulatory development programs
in support of potential licensure, and development, manufacturing and scale-up activities, as well as activities related to broader
implementation of all three INTERCEPT systems in areas of Zika virus risk. Under the contract, BARDA reimburses us as allowable
direct contract costs are incurred plus allowable indirect costs. See “BARDA” below for more information.
Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments
associated with commercializing the INTERCEPT Blood System, including in connection with the continuing U.S. commercial launch
of our platelet and plasma systems, commitments to fund projects with Fresenius, costs to develop different configurations of existing
products and new products, including our illuminator, costs associated with planning, enrolling and completing ongoing studies, and
the post-approval studies we are required to conduct in connection with the FDA approval of the platelet system, costs associated with
pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs
associated with conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., including our
ongoing European Phase III clinical trial of our red blood cell system for chronic anemia patients, costs associated with performing the
agreed-upon activities under our BARDA agreement, and costs related to creating, maintaining and defending our intellectual
property. Our long-term capital requirements will also be dependent on the success of our sales efforts, competitive developments, the
timing, costs and magnitude of our longer-term clinical trials and other development activities related to our platelet, plasma and red
blood cell systems, including required post-approval studies for the platelet system, market preparedness and product launch activities
50
for any of our products in geographies where we do not currently sell our products, and regulatory factors. Until we are able to
generate a sufficient amount of product revenue and generate positive net cash flows from operations, which we may never do,
meeting our long-term capital requirements is in large part reliant on continued access to funds under our BARDA agreement and the
public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash
generated from operations and interest income earned on the investment of our cash balances. We believe that our available cash and
cash equivalents and short-term investments, as well as cash received from product sales and under our agreement with BARDA, will
be sufficient to meet our capital requirements for at least the next twelve months. We have based our cash sufficiency estimate on
assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, we could consume our available capital
resources sooner than we currently expect or in excess of amounts than we currently expect, which could adversely affect our
commercialization and clinical development activities.
We have borrowed and in the future may borrow additional capital from institutional and commercial banking sources to fund future
growth, including pursuant to our loan and security agreement with Oxford Finance, as described below, or potentially pursuant to
new arrangements with different lenders. We may borrow funds on terms that may include restrictive covenants, including covenants
that restrict the operation of our business, liens on assets, high effective interest rates and repayment provisions that reduce cash
resources and limit future access to capital markets. In addition, we may continue to pursue access to the equity capital markets to
support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our
stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering
arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in
certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our
stockholders.
As a result of economic conditions, general global economic uncertainty and other factors, we do not know whether additional capital
will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. If we are unable to
raise additional capital due to the volatile global financial markets, general economic uncertainty or other factors, we may need to
curtail planned development or commercialization activities. In addition, we may need to obtain additional funds to complete
development activities for the red blood cell system necessary for potential regulatory approval in Europe, if costs are higher than
anticipated or we encounter delays. We may need to obtain additional funding to conduct additional randomized controlled clinical
trials for existing or new products, particularly if we are unable to access any portion of the funding contemplated by our BARDA
agreement, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing
operations provide sufficient cash flow to conduct these trials.
Although we received FDA approval of our platelet and plasma systems in December 2014, our commercial efforts will be largely
focused on implementing INTERCEPT to customers with whom we have previously signed agreements and developing awareness of
INTERCEPT’s product profile relative to other platelet and plasma products, including conventional, un-treated components.
Significant product revenue from customers in the U.S. may not occur, if at all, until we have been able to successfully implement the
platelet and plasma systems and demonstrate that they are economical, safe and efficacious for potential customers. We recognize
product revenues from the sale of our platelet and plasma systems in a number of countries around the world including those in
Europe, the Commonwealth of Independent States, or CIS, and the Middle East. If we are unable to gain widespread commercial
adoption in markets where our blood safety products are approved for commercialization, including the U.S., we will have difficulties
achieving profitability. In order to commercialize all of our products and product candidates, we will be required to conduct
significant research, development, preclinical and clinical evaluation, commercialization and regulatory compliance activities for our
products and product candidates, which, together with anticipated selling, general and administrative expenses, are expected to result
in substantial losses. Accordingly, we may never achieve a profitable level of operations in the future.
In addition to the product revenues from sales of our platelet and plasma systems, we anticipate that we will continue to recognize
revenue from our BARDA agreement. We recognize revenue associated with the BARDA agreement as qualified costs are incurred
for reimbursement over the performance period.
Aduro Biotech
We hold an investment in Aduro Biotech Inc., or Aduro, common stock totaling 346,700 shares. Aduro trades on the NASDAQ
Global Select Market, under the symbol “ADRO”. As of December 31, 2016, the fair value of Aduro’s common stock was $11.40 per
share. We account for the investment in Aduro as an available-for-sale security on our consolidated balance sheet and adjust the
carrying value of this investment to fair value each quarterly reporting period with changes in fair value recorded within other
comprehensive income (loss), net of tax. Prior to Aduro’s initial public offering in April 2015, we held the investment in Aduro at
zero on our consolidated balance sheet.
51
Fresenius
Through June 30, 2015, we paid royalties to Fenwal Inc., or Fenwal, a subsidiary of Fresenius Kabi AG, or Fresenius, on
INTERCEPT Blood System product sales under certain agreements that arose from the sale of the transfusion therapies division of
Baxter International Inc., or Baxter, in 2007 to Fenwal (Fenwal was subsequently acquired by Fresenius in 2012), at rates that varied
by product: 10% of product sales for the platelet system and 3% of product sales for the plasma system. Fresenius assumed Fenwal’s
rights and obligations under those agreements, including our manufacturing and supply agreement. In this report, references to
Fresenius include references to its predecessors-in-interest, Fenwal and Baxter.
In November 2013, we amended our manufacturing and supply agreement with Fresenius with the new terms effective January 1,
2014, which we refer to as the 2013 Agreement. Under the 2013 Agreement, Fresenius was obligated to sell, and we were obligated to
purchase up to a certain specified annual volume of finished disposable kits for the platelet and plasma systems from Fresenius for
both clinical and commercial use. Once the specified annual volume of disposable kits was purchased from Fresenius, we were able to
purchase additional quantities of disposable kits from other third-party manufacturers. The amended terms also provided for fixed
pricing for finished kits with successive decreasing pricing tiers at various annual production volumes. In addition, the 2013
Agreement required us to purchase additional specified annual volumes of sets if and when an additional Fresenius manufacturing site
was identified and qualified to make INTERCEPT disposable kits, subject to mutual agreement on pricing for disposable kits
manufactured at the additional site. Fresenius was also obligated to purchase and maintain specified inventory levels of our proprietary
inactivation compounds and compound adsorption devices from us at fixed prices.
In October 2015, we entered into a ten year Amended and Restated Manufacturing and Supply Agreement, or the 2015 Agreement,
with Fresenius, which amended and restated the 2013 Agreement. Under the 2015 Agreement, Fresenius continues to be obligated to
sell and we are obligated to purchase finished disposable kits for our platelet, plasma and red blood cell systems. The 2015 Agreement
permits us to purchase platelet, plasma and red blood cell systems from third parties to the extent necessary to maintain supply
qualifications with such third parties or where local or regional manufacturing is needed to obtain product registrations or sales.
Pricing terms are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial
pricing term.
Under the 2015 Agreement, we are no longer required to make royalty payments to Fenwal for the sale of products after June 30,
2015. Under the 2015 Agreement, we maintain the amounts due from the components sold to Fresenius as a current asset on our
accompanying consolidated balance sheets until such time as we purchase finished disposable kits using those components. The 2015
Agreement also requires us to make certain payments totaling €8.6 million, or the Manufacturing and Development Payments, to
Fresenius in 2016 and on December 31 of the earlier of (a) the year of achievement of certain production volumes or (b) 2022.
Because these payments represent unconditional payment obligations, we recognize our liability for these payments at their net present
value. The Manufacturing and Development Payments liability is accreted through interest expense based on the estimated timing of
its ultimate settlement. As of December 31, 2016, we had accrued $4.8 million (€4.5 million) related to the Manufacturing and
Development Payments.
The Manufacturing and Development Payments will be made to support certain projects Fresenius will perform on our behalf related
to research and development, or R&D activities and manufacturing efficiency activities. We allocated $4.8 million to R&D activities
and $2.4 million to manufacturing efficiency activities based on their market value in October 2015. The prepaid asset related to
amounts paid up front for the R&D activities to be conducted by Fresenius on our behalf is expensed over the period which such
activities occur. The manufacturing efficiency asset is expensed on a straight line basis over the life of the 2015 Agreement.
The initial term of the 2015 Agreement extends through July 1, 2025, or the Initial Term, and is automatically renewed thereafter for
additional two year terms, or Renewal Terms, subject to termination by either party upon (i) two years written notice prior to the
expiration of the Initial Term or (ii) one year written notice prior to the expiration of any Renewal Term. Under the 2015 Agreement,
we have the right, but not the obligation, to purchase certain assets and assume certain liabilities from Fresenius. In the event that
Fresenius refuses or is unable to continue operating under the 2015 Agreement, we may be unable to maintain inventory levels or
otherwise meet customer demand, and our business and operating results would be materially and adversely affected.
Likewise, if we conclude that supply of the INTERCEPT Blood System or components from Fresenius and others is uncertain, we
may choose to build and maintain inventories of raw materials, work-in-process components, or finished goods, which would consume
capital resources faster than we anticipate and may cause our supply chain to be less efficient. Like most regulated manufacturing
processes, our ability to produce our products is dependent on our or Fresenius’ ability to source components and raw materials which
may at times be in short demand or obsolete. In such cases, we and/or Fresenius may need to source, qualify and obtain approval for
replacement materials or components which would likely prove to be disruptive and consume capital resources sooner than we
anticipate.
52
BARDA
In June 2016, we entered into an agreement with BARDA to support our development and implementation of pathogen reduction
technology for platelet, plasma, and red blood cells, including access to funding that could potentially support various activities,
including funding studies necessary to support a potential PMA submission to the FDA for the red blood cell system, and acceleration
of commercial scale up activities to facilitate potential adoption of the red blood cell system by U.S. blood centers.
The five-year agreement with BARDA includes a base period, or the Base Period, and options, or Option Periods. The five-year
agreement, as amended by BARDA, and Option Periods exercised include committed funding of up to $41.6 million for clinical
development of the red blood cell system and subsequent Option Periods that, if exercised by BARDA and completed, would bring the
total funding opportunity to $185.0 million over the five-year agreement period. If exercised by BARDA, each subsequent option
would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of Zika
virus risk, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S.,
and development, manufacturing and scale-up activities for the red blood cell system. We would be responsible for co-investment of
up to $15.0 million, if certain options were to be exercised. BARDA will make periodic assessments of our progress and the
continuation of the agreement is based on our success in completing the required tasks under the Base Period and each Option Period
(if and to the extent any Option Periods are exercised by BARDA). BARDA has rights under certain contract clauses to terminate the
agreement, including the ability to terminate for convenience at any time.
Under the agreement, we are reimbursed and recognize revenue as qualified direct contract costs are incurred plus allowable indirect
costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and
administrative expenses. Amounts payable under the BARDA agreement are subject to future audits at the discretion of government.
These audits could result in an adjustment to revenue previously reported, which adjustments potentially could be significant.
Equity and Debt Agreements
Cantor
On May 5, 2016, we entered into Amendment No. 2 to the Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, as
previously amended on March 21, 2014, which together we refer to as the Amended Cantor Agreement, with Cantor Fitzgerald & Co.,
or Cantor, that provides for the issuance and sale of shares of our common stock over the term of the Amended Cantor Agreement
having an aggregate offering price of up to $132.2 million through Cantor. Under the Amended Cantor Agreement, Cantor acts as our
sales agent and receives compensation based on an aggregate of 2% of the gross proceeds on the sale price per share of our common
stock. The issuance and sale of these shares by us pursuant to the Amended Cantor Agreement are deemed an “at-the-market” offering
and are available under the Securities Act of 1933, as amended. During the year ended December 31, 2016 and 2015, 3.5 million and
zero shares, respectively, of our common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $22.0
million and zero, respectively. At December 31, 2016, we had $62.3 million of common stock available to be sold under the Amended
Cantor Agreement, subject to the continued effectiveness of our current shelf registration statement or an effective replacement
registration statement.
Debt Agreement
On June 30, 2014, we entered into a five year loan and security agreement with Oxford Finance, or the Term Loan Agreement. On
June 30, 2014, we received $10.0 million from the first tranche, or Term Loan A. On June 15, 2015, we received $10.0 million from
the second tranche, or Term Loan B. On September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in
which the third tranche could have been drawn and (ii) the interest-only period for all advances under the Term Loan Agreement.
Term Loan A bears an interest rate of 6.95%, and Term Loan B bears an interest rate of 7.01%. Term Loans A and B mature on
June 1, 2019. Following the amendment to Term Loan Agreement, we were required to make interest only payments through June
2016 followed by thirty-six months of equal principal and interest payments thereafter. On July 28, 2016, the Term Loan Agreement
was again amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, we
are required to make interest only payments from August 2016 through January 2017, followed by twenty-nine months of equal
principal and interest payments thereafter. We are also required to make a final payment equal to 7% of the principal amounts of the
Term Loans drawn payable on the earlier to occur of maturity or prepayment. We pledged all current and future assets, excluding our
intellectual property and 35% of our investment in our subsidiary, Cerus Europe B.V., as security for borrowings under the Term Loan
Agreement. The Term Loan Agreement contains certain nonfinancial covenants, with which we were in compliance at December 31,
2016. For additional discussion on the Term Loan Agreement, see “Commitments and Off-Balance Sheet Arrangements—Debt.”
53
Critical Accounting Policies and Management Estimates
The preparation of financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of
assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, we evaluate
our estimates, including those related to revenue recognition, inventory valuation, certain accrued liabilities, valuation and impairment
of purchased intangibles and goodwill, valuation of stock options under share-based payments, valuation allowance of our deferred tax
assets and uncertain income tax positions. We base our estimates on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying value
of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different
assumptions or conditions.
We believe the following critical accounting policies require us to make significant judgments and estimates used in the preparation of
our financial statements:
• Revenue—We recognize revenue in accordance with Accounting Standards Codification, or ASC, Topic 605-25, “Revenue
Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of the
agreement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collection is
reasonably assured.
Revenue related to product sales is generally recognized when we fulfill our obligations for each element of an agreement. For all
sales of our INTERCEPT Blood System products, we use a binding purchase order or signed sales contract as evidence of a written
agreement. We sell our platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to
distributors in certain regions. Generally, our contracts with our customers do not provide for open return rights, except within a
reasonable time after receipt of goods in the case of defective or non-conforming product. For revenue arrangements with multiple
elements, we determine whether the delivered elements meet the criteria as separate units of accounting. Such criteria require that the
deliverable have stand-alone value to the customer and that if a general right of return exists relative to the delivered item, delivery or
performance of the undelivered item(s) is considered probable and substantially in the control. Once we determine if the deliverable
meets the criteria for a separate unit of accounting, we must determine how the consideration should be allocated between the
deliverables and how the separate units of accounting should be recognized as revenue. Consideration received is allocated to
elements that are identified as discrete units of accounting. Because we have no vendor specific objective evidence or third party
evidence for our systems, the allocation of revenue is based on best estimated selling price for the platelet and plasma systems sold.
The objective of best estimated selling price is to determine the price at which we would transact a sale, had the product been sold on a
stand-alone basis. We determine best estimated selling price for our platelet and plasma systems by considering multiple factors.
• Government contracts revenue - Revenue related to the cost reimbursement provisions under our BARDA agreement is recognized
as the allowable direct contract costs plus allowable indirect costs are incurred based on approved provisional indirect billing rates,
which permit recovery of fringe benefits, overhead and general and administrative expenses. Direct costs incurred under cost
reimbursable contracts are recorded as research and development expenses or general and administrative expenses. Payments to us
pursuant to our BARDA agreement are provisional payments subject to adjustment upon audit by the government. These audits could
result in an adjustment to revenue previously reported, which adjustments potentially could be significant. Management believes that
revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement.
When the final determination of the allowable costs for any year has been made, revenue and billings may be adjusted accordingly in
the period that the adjustment is known.
• Inventories—We own certain components of INTERCEPT disposable kits in the form of work-in-process inventory and finished
goods, UVA illuminators, and certain replacement parts for our illuminators. While it is not customary for our inventory production
cycle to exceed twelve months, our supply chain for certain of these components, held as work-in-process on our consolidated balance
sheets, could potentially take in excess of one year to complete production before being utilized in finished INTERCEPT disposable
kits. We maintain an inventory balance based on our current sales projections, and at each reporting period, we evaluate whether our
work-in-process inventory will be consumed in production of finished units in order to sell to existing and prospective customers
within the next twelve-month period. We use judgment to factor in lead times for the production of our finished units to meet
forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods
exceeding one year.
Inventory is recorded at the lower of cost, determined on a first in, first-out basis, or net realizable value. Our platelet and plasma
systems’ disposable kits generally have a two-year shelf life from the date of manufacture.
Illuminators and replacement parts do not have regulated expiration dates. We use significant judgment to analyze and determine if the
composition of our inventory is obsolete, slow-moving, or unsalable and frequently review such determinations. We write-down
54
specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is
first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any
write-down of our inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances
suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in
“Cost of product revenue” on our consolidated statements of operations.
• Accrued liabilities—We record accrued liabilities for expenses related to certain contract research activities and development
services, including those related to clinical trials, preclinical safety studies and external laboratory studies, as well as development
activities being performed by third parties. Some of those accrued liabilities are based on estimates because billings for these activities
may not occur on a timely basis consistent with the performance of the services. Specifically, accruals for clinical trials require us to
make estimates surrounding costs associated with patients at various stages of the clinical trial, pass through costs to clinical sites,
contract research organization costs including fees, database development, and reporting costs, among others.
• Goodwill and intangible assets—In August 2010, we acquired certain assets from BioOne. We accounted for the acquisition as a
business combination in accordance with ASC Topic 805, “Business Combinations.” In connection with the acquisition, we used
significant judgment, including, but not limited to, judgments as to cash flows, discount rates, and economic lives, in identifying the
assets acquired and in determining the fair values to record the purchased assets on our consolidated balance sheets. In addition, under
ASC Topic 805, we were required to assess the fair value of the non-controlling interest that we held in BioOne prior to the
acquisition. We determined that a considerable amount of the purchase consideration was goodwill, which represents value unique to
us as the holder of worldwide rights to the INTERCEPT Blood System. We may be unable to realize the recorded value of the
acquired assets and our assumptions may prove to be incorrect, which may require us to write-down or impair the value of the assets if
and when facts and circumstances indicate a need to do so. We perform an impairment test on our goodwill annually on August 31 of
each fiscal year or more frequently if indicators of impairment exist. If we determine that it is more likely than not that the fair value
of a reporting unit is less than the carrying amount, we must then proceed with performing the quantitative two-step process to test
goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. We may choose not to
perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however,
we may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step
process compares the fair value of each reporting unit with the respective carrying amount, including goodwill. We have determined
that we operate in one reporting unit and estimate the fair value of our one reporting unit using the enterprise approach under which
we consider our quoted market capitalization as reported on the Nasdaq Global Market. We consider quoted market prices that are
available in active markets to be the best evidence of fair value. We also consider other factors, which include future forecasted
results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds the carrying amount,
goodwill of the reporting unit is not considered impaired and, therefore, the second step of the impairment test is unnecessary. The
second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each
reporting unit’s goodwill with the respective carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill
exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. On August 31,
2016, we performed our annual review of goodwill as described above and determined that goodwill was not impaired during the year
ended December 31, 2016. We will continue to monitor events and changes in circumstances that could indicate carrying amounts of
our intangible assets may not be recoverable. When such events or changes in circumstances occur, we assess recoverability by
determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the
expected undiscounted future cash flows are less than the carrying amount of these assets, we then measure the amount of the
impairment loss based on the excess of the carrying amount over the fair value of the assets. No events or changes in circumstances
arose during the year ended December 31, 2016, which would require us to test the recoverability of our intangible assets.
• Stock-based compensation—We issue stock-based awards to our employees, contractors and members of our Board of Directors,
as strategic, long-term incentives. We also maintain an active employee stock purchase plan within the meaning of Section 423(b) of
the Internal Revenue Code. We record stock-based compensation expense for employee awards in accordance with ASC Topic 718,
“Compensation—Stock Compensation.” We use the Black-Scholes option pricing model to determine the grant-date fair value of
stock-based awards. The Black-Scholes option pricing model requires that we use assumptions regarding a number of complex and
subjective variables to determine appropriate inputs to the model, which include the expected term of the grants, actual and projected
employee stock option exercise behaviors, including forfeitures, our expected stock price volatility, the risk-free interest rate and
expected dividends. The grant-date fair value of stock-based awards is then recognized as stock-based compensation expense on a
straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent
that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are
probable of being achieved.
We apply the provisions of ASC Topic 505-50, “Equity Based Payment to Non-Employees” for our stock-based awards issued to non-
employees. Under those provisions, the measurement date at which the fair value of the stock-based award is measured is the earlier of
55
(i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the
grantee’s performance is complete.
• Income taxes—Since our inception, we have accumulated significant net operating losses and research and development credits that
may be used in future periods to offset future taxable income. We currently estimate that we may not be able to utilize all of our
deferred tax assets. In addition, we may not generate future taxable income prior to the expiration of our net operating loss carry
forwards and research and development credits. Timing and significance of any estimated future taxable income is highly subjective
and is beyond the control of management due to uncertainties in market conditions, economic environments in which we operate, and
timing of regulatory approval of our products. We do not recognize tax positions that do not have a greater than 50% likelihood of
being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance is
not an appropriate substitute for the derecognition of a tax position. We recognize accrued interest and penalties related to
unrecognized tax benefits in our income tax expense. To date, we have not recognized any interest and penalties in our consolidated
statements of operations, nor have we accrued for or made payments for interest and penalties. We continue to carry a full valuation
allowance on all of our deferred tax assets. Although we believe it more likely than not that a taxing authority would agree with our
current tax positions, there can be no assurance that the tax positions we have taken will be substantiated by a taxing authority if
reviewed. Our U.S. federal tax returns from 1998 through 2015 and all our California tax returns through 2015 remain subject to
examination by the taxing jurisdictions due to unutilized net operating losses and research credits.
Results of Operations
Years Ended December 31, 2016, 2015 and 2014
Revenue
(in thousands, except percentages)
Product revenue .................................................................... $
Government contracts revenue ..............................................
Total revenue ................................................................... $
2016
37,183 $
2,092
39,275 $
2015
34,223 $
—
34,223 $
2014
36,416
—
36,416
Year Ended December 31,
% Change
2016
to 2015
2015
to 2014
9%
N/A
15%
(6%)
N/A
(6%)
Product revenue increased by $3.0 million during the year ended December 31, 2016, compared to the year ended December 31, 2015,
attributable mainly to increased illuminator sales primarily in the U.S market and increased sales volume of disposable platelet and
plasma system kits in our European and Middle Eastern markets.
Product revenue decreased by $2.2 million during the year ended December 31, 2015, compared to the year ended December 31,
2014. The primary driver for the decline in reported product revenue was the weakening of the average Euro relative to our reporting
currency, the U.S. dollar, of approximately 16% during the year ended December 31, 2015, compared to the year ended December 31,
2014. During the periods presented, most of our product revenue was invoiced and transacted in Euros with reported revenue in U.S.
dollars. The decrease in product revenue during the year ended December 31, 2015 was partially offset by a higher unit sales volume
of our disposable platelet and plasma system kits of 15%.
We anticipate product revenue will increase in future periods as the INTERCEPT Blood System gains market acceptance in
geographies where commercialization efforts are underway, including anticipated contribution from U.S. sales and newly accessible
geographies. However, deterioration in the Euro relative to the U.S. dollar and continued general declines in the economic climate in
Russia and the CIS markets would adversely impact product revenue as the majority of our revenues are expected to come from Euro
denominated markets and the CIS markets. As a result of these and other factors, the historical results may not be indicative of
INTERCEPT Blood System revenue in the future.
We recognized $2.1 million revenue from our BARDA agreement during the year ended December 31, 2016, as a result of the direct
and indirect contract costs incurred in the Base Period and certain Option Periods under the BARDA agreement. We did not recognize
any revenue from our BARDA agreement during the years ended December 31, 2015 and 2014.
56
Cost of Product Revenue
Our cost of product revenue consists of the cost of the INTERCEPT Blood System inventory sold; provisions for obsolete, slow-
moving and unsaleable product; certain order fulfillment costs, to the extent applicable, costs for idle facilities, and, prior to
October 19, 2015, royalties payable to Fenwal for product sales. Inventory is accounted for on a first-in, first-out basis.
(in thousands, except percentages)
Cost of product revenue ........................................................ $
2016
20,295 $
2015
23,464 $
2014
21,188
2016
to 2015
2015
to 2014
(14%)
11%
Year Ended December 31,
% Change
Cost of product revenue decreased by $3.2 million during the year ended December 31, 2016, compared to the year ended
December 31, 2015. The decrease was primarily the result of the elimination of the royalty to Fenwal in the fourth quarter of 2015 and
decreased obsolescence and manufacturing charges in 2016 compared to the prior year.
Cost of product revenue increased by $2.3 million during the year ended December 31, 2015, compared to the year ended
December 31, 2014. The increase was primarily the result of higher unit sales volume and increase of $1.8 million in obsolescence and
manufacturing charges, partially offset by inventory produced during periods of more favorable foreign currency exchange rates.
Similar to our revenues, during the periods presented, a significant majority of our product was sourced from vendors transacting in
Euros and reported by us in U.S. dollars. Per unit cost of product sold declined by 11.4% during the year ended December 31, 2015
compared to 2014.
Our realized gross margin on product sales was 45% during the year ended December 31, 2016, up from 31% during the year ended
December 31, 2015. The increase in gross margins on product sales was primarily due to the elimination of the royalty to Fenwal in
the fourth quarter of 2015, decreased obsolescence and manufacturing charges, increased illuminator sales, and efficiencies realized
related to inventory management during the year ended December 31, 2016, compared to the year ended December 31, 2015.
Our gross margin on product sales was 31% during the year ended December 31, 2015, compared to 42% during the year ended
December 31, 2014. The decrease in gross margins on product sales, compared to the year ended December 31, 2014, was primarily
due to the deterioration in the Euro relative to the U.S. dollar on current period revenues and increased obsolescence and
manufacturing charges, partially offset by the impact on cost of revenues which were recorded at more favorable foreign exchange
rates in effect at the time the inventory was purchased. In addition, increased period charges for outdated product also resulted in the
overall decreases in gross margins during the year ended December 31, 2015, compared to the year ended December 31, 2014.
Changes in our gross margins are affected by various factors, including the exchange rate of the Euro relative to the U.S dollar,
manufacturing and supply chain costs, the mix of product sold, and the mix of customers to which product is sold. Generally, we offer
our distributors tiered volume discounts of varying magnitudes, depending on their annual purchases. We may encounter unforeseen
manufacturing difficulties which, at a minimum, may lead to higher than anticipated costs, scrap rates, or delays in manufacturing
products. In addition, we may face competition which may limit our ability to maintain existing selling prices for our products which
in turn would negatively affect our reported gross margins. Our gross margins may be impacted in the future based on all of these
criteria.
We expect to maintain inventory levels that will be sufficient to meet forecasted demand for a relatively short time period and plan to
manufacture at levels above those produced in 2016.
Research and Development Expenses
Our research and development expenses include salaries and related expenses for our scientific personnel, non-cash stock based
compensation, payments to consultants, costs to prepare and conduct preclinical and clinical trials, third-party costs for development
activities, certain regulatory costs, costs associated with our facility related infrastructure, and laboratory chemicals and supplies.
(in thousands, except percentages)
Research and development .................................................... $
2016
31,322 $
2015
25,643 $
2014
21,800
Year Ended December 31,
% Change
2016
to 2015
2015
to 2014
22%
18%
Research and development expenses increased by $5.7 million during the year ended December 31, 2016, compared to the year ended
December 31, 2015, primarily due to increased costs associated with clinical development of our red blood cell system, our pursuit of
PMA supplement approvals for the platelet and plasma systems, and the initial activities under the BARDA agreement.
57
Research and development expenses increased by $3.8 million during the year ended December 31, 2015, compared to the year ended
December 31, 2014, primarily due to increased costs associated with pursuing potential label claim extensions for the platelet system
in the U.S., conducting our IDE studies, development of a new generation of our illuminator, and development activities for our red
blood cell program.
We expect to incur additional research and development costs associated with planning, enrolling and completing our required post-
approval studies for the platelet system, pursuing potential regulatory approvals in other geographies where we do not currently sell
our platelet and plasma systems, planning and conducting in vitro studies and clinical development of our red blood cell system in
Europe and the U.S., completing activities to support a potential CE mark submission for our red blood cell system in Europe, and
costs associated with performing the activities under our BARDA agreement. Due to the inherent uncertainties and risks associated
with developing biomedical products, including, but not limited to, intense and changing government regulation, uncertainty of future
preclinical studies and clinical trial results and uncertainty associated with manufacturing, it is not possible to reasonably estimate the
costs to complete these research and development projects. We face numerous risks and uncertainties associated with the successful
completion of our research and development projects, which risks and uncertainties are discussed in further detail under “Item 1A—
Risk Factors” in Part I of this Annual Report on Form 10-K.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses include salaries and related expenses for administrative personnel, non-cash stock based
compensation, expenses for our commercialization efforts in a number of countries around the world including those in U.S., Europe,
the CIS and the Middle East, Asia, Latin America, and expenses for accounting, tax, internal control, legal, facility and infrastructure
related expenses, and insurance premiums.
(in thousands, except percentages)
Selling, general and administrative ....................................... $
2016
48,753 $
2015
45,989 $
2014
37,729
Year Ended December 31,
% Change
2016
to 2015
2015
to 2014
6%
22%
Selling, general, and administrative expenses increased by $2.8 million during the year ended December 31, 2016, compared to the
year ended December 31, 2015, primarily due to increased spending related to general corporate activities associated with the
increased commercial activities targeting and servicing new and potential U.S. customers and the development activities under
BARDA agreement.
Selling, general, and administrative expenses increased by $8.3 million during the year ended December 31, 2015, compared to the
year ended December 31, 2014, primarily due to increased spending related to activities associated with the U.S. launch of our plasma
and platelet products which increased over the course of 2015 and to a lesser extent, increases in back-office support functions.
We anticipate our selling, general, and administrative spending to increase over the coming year, as we as we undertake additional
activities associated with performing the activities under our BARDA agreement and continue to on-board commercial capabilities in
the U.S., including incremental back-office support, sales and marketing personnel, as well as medical science liaisons to educate
hospital and physicians on our products and drive hospital demand for INTERCEPT-treated blood components.
Amortization of Intangible Assets
Amortization of intangible assets relates to a license to commercialize the INTERCEPT Blood System in certain Asian countries.
These intangible assets are being amortized over an estimated useful life of ten years and will be reviewed for impairment.
(in thousands, except percentages)
Amortization of intangible assets .......................................... $
Year Ended December 31,
2016
2015
2014
% Change
2016
to 2015
2015
to 2014
202 $
202 $
202
0%
0%
Amortization of intangible assets remained flat during the year ended December 31, 2016, compared to the years ended December 31,
2015 and 2014, as there were no changes to the composition of our intangible assets or the assumptions used to determine the useful
lives. In addition, no impairment charges were recognized related to our intangible assets during the years ended December 31, 2016,
2015 and 2014.
We expect that the amortization of our intangible assets to remain relatively consistent in future periods, unless facts and
circumstances arise which may result in our intangible assets being impaired.
58
Non-Operating (Expense) Income, Net
Non-operating (expense) income, net consists of mark-to-market adjustments related to the calculated fair value of our previously-
outstanding warrants, foreign exchange gain (loss), interest charges incurred on our debt, and other non-operating gains and losses,
including interest earned from our short-term investment portfolio.
(in thousands, except percentages)
Gain from revaluation of warrant liability ............................ $
Foreign exchange gain (loss) ................................................
Interest expense .....................................................................
Other income, net ..................................................................
Total non-operating (expense) income, net ..................... $
2016
2015
2014
— $
21
(2,445)
1,140
(1,284) $
3,566 $
(396)
(1,705)
71
1,536 $
7,708
(1,296 )
(599 )
130
5,943
2016
to 2015
2015
to 2014
(100%)
(105%)
43%
1,506%
(184%)
(54%)
(69%)
185%
(45%)
(74%)
Year Ended December 31,
% Change
Warrant liability
In August 2009 and November 2010, we issued warrants to purchase an aggregate of 2.4 million and 3.7 million shares of common
stock, respectively, in connection with offerings of our common stock. In August 2014 and November of 2015, all of the outstanding
August 2009 and November 2010 warrants, respectively, were exercised. The fair value of the outstanding warrants, which used the
Black-Scholes model, was classified as a liability on our consolidated balance sheet and was adjusted at each subsequent reporting
period, until such time the warrants were exercised. Upon exercise, the fair value of the warrants was reclassified from liabilities to
stockholders’ equity. We had no outstanding warrants during the year ended December 31, 2016.
We recorded a non-cash gain from the revaluation of the warrant liability of $3.6 million for the year ended December 31, 2015,
compared to a non-cash gain of $7.7 million for the year ended December 31, 2014. This change is primarily due to the change in our
underlying stock price as compared to the strike price of the warrants and the exercise of warrants during the current year.
Foreign exchange gain (loss)
We recorded a foreign exchange gain of less than $0.1 million during the year ended December 31, 2016, compared to a foreign
exchange loss during the year ended December 31, 2015, primarily attributable to favorable foreign currency variations between the
Euro and U.S. dollar during the current year compared to unfavorable variations in the prior.
Foreign exchange loss decreased to $0.4 million during the year ended December 31, 2015, compared to a loss of $1.3 million during
the year ended December 31, 2014, primarily attributable to stabilization of foreign currency variations between the Euro and U.S.
dollar, our functional currency, in 2015 as compared to the Euro and U.S. dollar exchange rates in 2014.
Interest expense
Interest expense increased by $0.7 million for the year ended December 31, 2016, compared to the year ended December 31, 2015,
and increased by $1.1 million for the year ended December 31, 2015, compared to the year ended December 31, 2014, primarily due
to a higher effective interest rate and larger average outstanding debt balance under our Term Loan Agreement (see discussion under
the heading “Debt” below), resulting from the drawdown of Term Loan B of $10.0 million in June 2015.
Other income, net
Other income, net increased by $1.1 million during the year ended December 31, 2016, compared to the year ended December 31,
2015, primarily due to the realized gain from the sale of 50,000 shares of our Aduro common stock, and the increased interest income
from our investments in marketable securities.
Other income, net remained consistent during the year ended December 31, 2015, compared to the year ended December 31, 2014.
Provision for Income Taxes
(in thousands, except percentages)
Provision (benefit) for income taxes ..................................... $
Year Ended December 31,
% Change
2016
2015
2014
2016
to 2015
2015
to 2014
175 $
(3,671) $
195
(105%)
(1,983%)
59
For the year ended December 31, 2016, we recorded a tax expense of $0.2 million, which was a result of our Cerus Europe B.V.
subsidiary’s operating profit.
The tax benefit of $3.7 million for the year ended December 31, 2015, was the result of the increased value of our Aduro investment
investments. The tax provision for the year ended December 31, 2014, primarily consisted of foreign taxes of our wholly-owned
subsidiary headquartered in Europe.
We do not provide for U.S. income taxes on undistributed earnings of our foreign operations as we intend to permanently reinvest
such earnings outside the U.S. Due to our history of cumulative operating losses, management has concluded that, after considering all
the available objective evidence, it is not likely that all our net deferred tax assets will be realized. Accordingly, all of our U.S.
deferred tax assets continue to be subject to a valuation allowance as of December 31, 2016.
Liquidity and Capital Resources
In recent years, our sources of capital have primarily consisted of public issuance of common stock, debt instruments, and to a lesser
extent, contribution from product sales and proceeds from government contracts.
At December 31, 2016, we had cash and cash equivalents of $22.6 million, compared to $71.0 million at December 31, 2015. Our
cash equivalents primarily consist of money market instruments, which are classified for accounting purposes as available-for-sale. In
addition, we had $49.1 million of short-term investments and investments in marketable equity securities at December 31, 2016, and
$36.9 million at December 31, 2015. We also had total indebtedness under our Term Loan Agreement of approximately $19.4 million
at December 31, 2016, and $19.8 million at December 31, 2015. Excess cash is typically invested in highly liquid instruments of
short-term investments with high-quality credit rated corporate and government agency fixed-income securities in accordance with our
investment policy. At December 31, 2016, our $4.0 million investment in marketable equity securities related solely to our investment
in Aduro.
Operating Activities
Net cash used in operating activities was $53.5 million for the year ended December 31, 2016, compared to $51.1 million during the
year ended December 31, 2015. The increase in net cash used in operating activities was primarily related to the increased cash spent
for development activities for our red blood cell program and selling and administrative expenses related to our continuing U.S.
commercial launch of our platelet and plasma systems, partially offset by a net increase in the combined total for our accounts payable
and accrued liabilities as a result of the timing of payments during the year ended December 31, 2016, as compared to the
corresponding period in 2015. The increase in net cash used in operating activities was also impacted by payments to Fresenius related
to the Manufacturing and Development Payments, and an increased inventory build during the year ended December 31, 2016,
compared to the corresponding period in 2015.
Net cash used in operating activities was $51.1 million for the year ended December 31, 2015, compared to $39.8 million during the
year ended December 31, 2014. The increase in net cash used in operating activities was primarily related to the level of cash spent for
development activities for our red blood cell program, support of our expanded use IDE for treatment of platelets, and selling and
administrative expenses related to the U.S. commercial launch of our platelet and plasma systems. Also contributing to this increase
in net cash used in operating activities were changes in working capital resulting from a decrease in our accounts payable due to the
accelerated timing of payments, coupled with an increase in accounts receivable during the year ended December 31, 2015, as
compared to the corresponding period in 2014.
Investing Activities
Net cash used in investing activities was $19.9 million for the year ended December 31, 2016, compared to $1.5 million of net cash
provided during the year ended December 31, 2015. The change period over period was primarily the result of lower proceeds from
maturities of investments in marketable securities during the year ended December 31, 2016, as compared to the same period in 2015,
partially offset by the proceeds from the sale of 50,000 shares of Aduro common stock.
Net cash provided in investing activities was $1.5 million for the year ended December 31, 2015, compared to $3.1 million of net cash
used during the year ended December 31, 2014. The change was primarily the result of maturities of short term investments in excess
of purchases of short term investments, and fewer capital expenditures in 2015.
60
Financing Activities
Net cash provided by financing activities was $24.6 million during the year ended December 31, 2016, compared to $98.0 million
during the year ended December 31, 2015. The decrease in net cash provided by financing activities was primarily due to the decrease
of proceeds received from public offerings. In January 2015, we issued 14.6 million shares of our common stock in an underwritten
public offering for approximately $75.3 million. This was further impacted by our drawdown of Term Loan B of $10.0 million in June
2015 and the proceeds from the exercise of warrants in 2015.
Net cash provided by financing activities was $98.0 million during the year ended December 31, 2015, compared to $36.5 million
during the year ended December 31, 2014. The increase in net cash provided by financing activities was primarily due to the proceeds
received from our January 2015 public offering of common stock. The net proceeds from this offering were approximately $75.3
million, net of underwriting discounts and other issuance costs. Net cash provided from financing activities was further increased by
our drawdown of Term Loan B of $10.0 million in June 2015. This was partially offset by the lack of issuances of our common stock
pursuant to the Amended Cantor Agreement during the year ended December 31, 2015.
Working Capital
Working capital decreased to $67.2 million at December 31, 2016, from $108.5 million at December 31, 2015, primarily due to the
cash used to support ongoing operations which resulted in lower cash and cash equivalent balances, and the decline of the market
value of our investment in Aduro. Working capital increased to $108.5 million at December 31, 2015, from $45.7 million at
December 31, 2014, primarily due to funds received from the January 2015 public offering, our drawdown of Term Loan B of $10.0
million in June 2015, and the valuation of our equity investment in Aduro common stock resulting from Aduro’s initial public offering
in April 2015, coupled with a decrease in our warrant liability. These increases were partially offset by cash used in operations during
2015.
Capital Requirements
Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments
associated with commercializing the INTERCEPT Blood System, including in connection with the continuing U.S. commercial launch
of our platelet and plasma systems, commitments to fund projects with Fresenius, costs to develop different configurations of existing
products and new products, including our illuminator, costs associated with planning, enrolling and completing ongoing studies, and
the post-approval studies we are required to conduct in connection with the FDA approval of the platelet system, costs associated with
pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs
associated with conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., including our
ongoing European Phase III clinical trial of our red blood cell system for chronic anemia patients, costs associated with performing the
agreed-upon activities under our BARDA agreement, and costs related to creating, maintaining and defending our intellectual
property. Our long-term capital requirements will also be dependent on the success of our sales efforts, competitive developments, the
timing, costs and magnitude of our longer-term clinical trials and other development activities related to our platelet, plasma and red
blood cell systems, including required post-approval studies for the platelet system, market preparedness and product launch activities
for any of our products in geographies where we do not currently sell our products, and regulatory factors. Until we are able to
generate a sufficient amount of product revenue and generate positive net cash flows from operations, which we may never do,
meeting our long-term capital requirements is in large part reliant on continued access to funds under our BARDA agreement and the
public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash
generated from operations and interest income earned on the investment of our cash balances. We believe that our available cash and
cash equivalents and short-term investments, as well as cash to be received from product sales and under our agreement with BARDA,
will be sufficient to meet our capital requirements for at least the next twelve months. We have based our cash sufficiency estimate on
assumptions that may prove to be incorrect. If our assumptions prove to be incorrect, we could consume our available capital
resources sooner than we currently expect or in excess of amounts than we currently expect, which could adversely affect our
commercialization and clinical development activities.
We have borrowed and in the future may borrow additional capital from institutional and commercial banking sources to fund future
growth, including pursuant to our loan and security agreement with Oxford Finance, as described below. We may borrow funds on
terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high
effective interest rates and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we
expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To
the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the
extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our
rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not
favorable to us, or issue equity that may be substantially dilutive to our stockholders.
61
While we expect to receive significant funding under our five-year agreement with BARDA, our ability to obtain the funding we
expect to receive under the agreement is subject to various risks and uncertainties, including with respect to BARDA’s ability to
terminate the agreement for convenience at any time. In addition, access to federal contracts is subject to the authorization of funds
and approval of our research plans by various organizations within the federal government, including the U.S. Congress. The general
economic environment, coupled with tight federal budgets, has led to a general decline in the amount available for government
funding. If BARDA were to eliminate, reduce or delay funding under our agreement, this would have a significant negative impact on
the programs associated with such funding and could have a significant negative impact on our revenues and cash flows. In addition, if
we are unable to reach agreement with the FDA on a license-enabling Phase III clinical trial design for our red blood cell system, our
agreement with BARDA will be severely limited in scope or could be terminated altogether, and our ability to complete the
development activities required for licensure in the U.S. may require additional capital beyond which we currently have. If alternative
sources of funding are not available, we may be forced to suspend or terminate development activities related to the red blood cell
system in the U.S.
As a result of economic conditions, general global economic uncertainty and other factors, we do not know whether additional capital
will be available when needed, or that, if available, we will be able to obtain additional capital on reasonable terms. If we are unable to
raise additional capital due to the volatile global financial markets, general economic uncertainty or other factors, we may need to
curtail planned development or commercialization activities. In addition, we may need to obtain additional funds to complete
development activities for the red blood cell system necessary for potential regulatory approval in Europe, if costs are higher than
anticipated or we encounter delays. We may need to obtain additional funding to conduct additional randomized controlled clinical
trials for existing or new products, particularly if we are unable to access any portion of the funding contemplated by our BARDA
agreement, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing
operations provide sufficient cash flow to conduct these trials.
Other Information
On May 5, 2016, we entered into Amendment No. 2 to the Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, as
previously amended on March 21, 2014, which together we refer to as the Amended Cantor Agreement, with Cantor Fitzgerald & Co.,
or Cantor, that provides for the issuance and sale of shares of our common stock over the term of the Amended Cantor Agreement
having an aggregate offering price of up to $132.2 million through Cantor. Under the Amended Cantor Agreement, Cantor acts as our
sales agent and receives compensation based on an aggregate of 2% of the gross proceeds on the sale price per share of our common
stock. The issuance and sale of these shares by us pursuant to the Amended Cantor Agreement are deemed an “at-the-market” offering
and are available under the Securities Act of 1933, as amended. During the year ended December 31, 2016, 3.5 million shares of our
common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $22.0 million. At December 31, 2016,
we had $62.3 million of common stock available to be sold under the Amended Cantor Agreement, subject to the continued
effectiveness of our current shelf registration statement or an effective replacement registration statement.
Commitments and Off-Balance Sheet Arrangements
Off-balance sheet arrangements
We did not have any off-balance sheet arrangements as of December 31, 2016 and 2015.
Contractual Commitments
The following summarizes our contractual commitments at December 31, 2016:
(in thousands)
Minimum purchase requirements ........................................... $
Manufacturing and development obligations .........................
Debt ........................................................................................
Operating leases .....................................................................
Other commitments ................................................................
Total contractual obligations ............................................ $
Minimum purchase requirements
Total
Less than
1 year
1 - 3 years
4 - 5 years
9,521 $
5,784
22,760
2,872
952
41,889 $
6,485 $
—
8,172
1,233
677
16,567 $
914 $
5,784
14,588
1,607
275
23,168 $
After 5 years
—
—
—
—
—
—
2,122 $
—
—
32
—
2,154 $
Our minimum purchase commitments include certain components of our INTERCEPT Blood System which we purchase from third
party manufacturers.
62
Manufacturing and development obligations
On October 19, 2015, we entered into the 2015 Agreement with Fresenius. The 2015 Agreement calls for a remaining payment of $5.8
million (€5.5 million) on December 31 of the year in which certain production volumes are achieved, or December 31, 2022,
whichever occurs first. We expect to achieve and the table above assumes that we achieve, the production threshold in 2019.
Operating leases
We generally lease our office facilities and certain equipment under non-cancelable operating leases with initial terms in excess of one
year that require us to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates
through 2021, with certain of the leases providing for renewal options, provisions for adjusting future lease payments, which is based
on the consumer price index and the right to terminate the lease early. Our leased facilities qualify as operating leases under ASC
Topic 840, “Leases” and as such, are not included on our consolidated balance sheets.
Other commitments
Our other commitments primarily consist of obligations for business insurance financing and the landlord financed leasehold
improvements, which are in addition to the operating leases we have for office and laboratory space and consulting fees. We pay for
the financed leasehold improvements as a component of rent and are required to reimburse our landlords over the remaining life of the
respective leases. At December 31, 2016, we had an outstanding liability of $0.5 million related to the remaining payments for the
financed business insurance and the $0.4 million related to these leasehold improvements.
Debt
On June 30, 2014, we entered into the Term Loan Agreement with Oxford Finance. On June 30, 2014, we received $10.0 million from
Term Loan A. On June 15, 2015, we received $10.0 million from Term Loan B. On September 29, 2015, the Term Loan Agreement
was amended to extend the period in which the third tranche could have been drawn and the interest-only period for all advances
under the Term Loan Agreement. Term Loan A bears an interest rate of 6.95%, and Term Loan B bears an interest rate of 7.01%.
Term Loans A and B mature on June 1, 2019. Following the amendment, we were required to make interest only payments through
June 2016 followed by thirty-six months of equal principal and interest payments thereafter. We are also required to make a final
payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment.
The costs associated with the final payment are recognized as interest expense over the principal life of the Term Loans. We may
prepay the Term Loans subject to declining prepayment fees over the term of the Term Loan Agreement. The Term Loan Agreement
contains certain nonfinancial covenants, with which we were in compliance at December 31, 2016. We pledged all current and future
assets, excluding our intellectual property and 35% of our investment in our subsidiary, Cerus Europe B.V., as security for borrowings
under the Term Loan Agreement. All principal and interest payments related to Term Loan have been included in the table above.
On July 28, 2016, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the
Term Loan Agreement. As amended, we are required to make interest only payments from August 2016 through January 2017
followed by twenty-nine months of equal principal and interest payments thereafter.
Financial Instruments
Our investment policy is to manage our marketable securities portfolio to preserve principal and liquidity while maximizing the return
on the investment portfolio to assist us in funding our operations. We currently invest our cash and cash equivalents in money market
funds and interest-bearing accounts with financial institutions. Our money market funds are classified as Level 1 in the fair value
hierarchy, in which quoted prices are available in active markets, as the maturity of money market funds are relatively short and the
carrying amount is a reasonable estimate of fair value. Our marketable equity securities consist of our investment in Aduro and are
classified as Level 1 in the fair value hierarchy, as quoted price in active markets is readily available. Our available-for-sale securities
related to corporate debt and U.S. government agency securities are classified as Level 2 in the fair value hierarchy, which uses
observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with
reasonable levels of price transparency. We maintain portfolio liquidity by ensuring that the securities have active secondary or resale
markets. We did not record any other-than-temporary impairment losses during the years ended December 31, 2016, 2015 and 2014.
Adverse global economic conditions have had, and may continue to have, a negative impact on the market values of potential
investments.
63
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
At December 31, 2016, we held cash, cash equivalents, short-term investments and investments in marketable equity securities of
$71.6 million. We do not believe our exposure to interest rate risk to be material given we held cash in interest-bearing accounts with
financial institutions and the short-term nature of our investment portfolio consisted of highly liquid money market instruments and
corporate debt and U.S. government agency securities with short-term maturities. The weighted average interest rates of our cash and
cash equivalents at December 31, 2016, were 0.55%.
Our exposure to market rate risk for changes in interest rates relates primarily to our money market instruments, corporate debt
securities and any amounts borrowed pursuant to the Term Loan Agreement. We do not use derivative financial instruments. By
policy, we may place investments with high quality debt security issuers, limit the amount of credit exposure to any one issuer and
limit duration by restricting the term for single securities and for the portfolio as a whole. Our investments are held and managed by a
third-party capital management adviser that in turn, utilizes a combination of active market quotes and where necessary, proprietary
pricing models as well as a subscribed pricing service, in order to estimate fair value. While we believe that we will be able to
recognize the fair value of our money market instruments when they mature or are sold, or if we purchase investments in securities in
the future, there can be no assurance that the markets for these securities will not deteriorate further or that the institutions that these
securities are with will be able to meet their debt obligations.
Foreign Currency Risk
Our international operations are subject to risks typical of an international business, including, among other factors: differing political,
economic, and regulatory climates, different tax structures, and foreign exchange volatility. We do not currently enter into any
hedging contracts to normalize the impact of foreign exchange fluctuations. As a result, our future results could be materially
impacted by changes in these or other factors.
Product sales for our blood safety products are predominantly made in Europe and generally are invoiced to customers in Euro. In
addition, we incur operating expenses, including payment for finished goods inventory of disposable kits for the platelet and plasma
systems. These inventory purchases and operating expenses are generally paid in Euro and, to a much lesser degree, other foreign
currencies. Our exposure to foreign exchange rate volatility is a direct result of our product sales, cash collection and expenses to
support our international operations. Foreign exchange rate fluctuations are recorded as a component of non-operating income
(expense), net on our consolidated statements of operations. Significant fluctuations in the volatility of foreign currencies relative to
the United States dollar may materially impact our results of operations. An unfavorable 10% change in foreign currency exchange
rates for our cash, accounts receivable, accounts payable and accrued liabilities that are denominated in foreign currencies at
December 31, 2016, would have negatively impacted our annual financial results by $0.3 million. Currently we do not have any near-
term plans to enter into a formal hedging program to mitigate the effects of foreign currency volatility.
Equity Market Risk
Our investment in marketable equity securities consists of our investment in Aduro common stock. Aduro’s common stock trades on
the NASDAQ Global Select Market under the symbol “ADRO”. At December 31, 2016, the fair value of our investment in Aduro was
$4.0 million. This investment is subject to the underlying volatility of Aduro’s common stock price and each $1 change in the price
per share of Aduro’s common stock will change the fair value of our investment by $0.3 million.
Item 8.
Financial Statements and Supplementary Data
Our consolidated financial statements, together with related notes and reports of Ernst & Young LLP, independent registered public
accounting firm, are listed in Item 15(a) and included herein.
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
64
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our principal executive officer and principal financial officer are responsible for establishing and maintaining “disclosure controls and
procedures” (as defined in Rules 13a-15(e) and 15d-15(e), promulgated under the Securities Exchange Act of 1934, as amended) for
our company. Based on their evaluation of our disclosure controls and procedures as of the end of the period covered by this Annual
Report on Form 10-K, our principal executive officer and principal financial officer have concluded that our disclosure controls and
procedures were effective as of December 31, 2016.
Limitations on the Effectiveness of Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives
of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute
assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures
are designed to provide reasonable assurance, not absolute assurance, that the objectives of our disclosure control system are met and,
as set forth above, our principal executive officer and principal financial officer have concluded, based on their evaluation as of the
end of the period covered by this Annual Report on Form 10-K, that these controls and procedures were effective at the “reasonable
assurance” level.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules
13a-15(f) under the Securities Exchange Act of 1934, as amended. Internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles in the United States of America.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2016.
Management based its assessment on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway
Commission (2013 framework) in Internal Control—Integrated Framework. Based on this evaluation, our management concluded that
as of December 31, 2016, our internal control over financial reporting was effective.
The effectiveness of our internal control over financial reporting as of December 31, 2016, has been audited by Ernst & Young LLP,
our independent registered public accounting firm, as stated in their attestation report, which is included below.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting which occurred during our fiscal quarter ended December 31,
2016, which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
65
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of Cerus Corporation
We have audited Cerus Corporation’s internal control over financial reporting as of December 31, 2016, based on criteria established
in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013
framework) (the COSO criteria). Cerus Corporation’s management is responsible for maintaining effective internal control over
financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the
accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the
company’s internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over
financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over
financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of
internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.
We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the
maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect
on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Cerus Corporation maintained, in all material respects, effective internal control over financial reporting as of
December 31, 2016, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the
consolidated balance sheets of Cerus Corporation as December 31, 2016 and 2015, and the related consolidated statements of
operations, comprehensive loss, stockholders’ equity, and cash flows for each of the three years in the period ended December 31,
2016, of Cerus Corporation and our report dated March 8, 2017 expressed an unqualified opinion thereon.
/s/ Ernst & Young LLP
Redwood City, California
March 8, 2017
66
Item 9B. Other Information
None.
67
PART III
Certain information required by Part III is omitted from this Annual Report on Form 10-K since we intend to file our definitive proxy
statement for our 2017 annual meeting of stockholders, or the Proxy Statement, pursuant to Regulation 14A of the Securities
Exchange Act of 1934, as amended, not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-
K, and certain information to be included in the proxy statement is incorporated herein by reference.
Item 10. Directors, Executive Officers and Corporate Governance
Information required by this item regarding executive officers, directors and nominees for directors, including information with
respect to our audit committee and audit committee financial expert, and the compliance of certain reporting persons with
Section 16(a) of the Securities Exchange Act of 1934, as amended, will be included in the Proxy Statement and is incorporated herein
by reference.
Code of Ethics
We have adopted the Cerus Corporation Code of Business Conduct and Ethics, or Ethics Code, that applies to all of our officers,
directors and employees. The Ethics Code is available on our website at www.cerus.com on the “Corporate Governance” page of the
section titled “Investors.” If we make any substantive amendments to the Ethics Code or grant any waiver from a provision of the
Ethics Code to any executive officer or director, we intend to promptly disclose the nature of the amendment or waiver as required by
applicable laws. To satisfy our disclosure requirements, we may post any waivers of or amendments to the Ethics Code on our website
in lieu of filing such waivers or amendments on a Form 8-K.
Our employees are required to report any conduct that they believe in good faith to be an actual or apparent violation of the Ethics
Code. The Audit Committee of our Board of Directors has established procedures to receive, retain and address complaints regarding
accounting, internal accounting controls or auditing matters and to allow for the confidential and anonymous submission by
employees of related concerns.
Item 11. Executive Compensation
The information required by this item is incorporated herein by reference to our Proxy Statement.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated herein by reference to our Proxy Statement.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated herein by reference to our Proxy Statement.
Item 14. Principal Accountant Fees and Services
The information required by this item is incorporated herein by reference to our Proxy Statement.
68
PART IV
Item 15. Exhibits and Financial Statement Schedules
The following documents are being filed as part of this Annual Report on Form 10-K:
(a) Financial Statements.
Report of Ernst & Young LLP, Independent Registered Public Accounting Firm .......................................................................
Consolidated Balance Sheets as of December 31, 2016 and 2015 ................................................................................................
Consolidated Statements of Operations for the three years ended December 31, 2016 ................................................................
Consolidated Statements of Comprehensive Loss for the three years ended December 31, 2016 ................................................
Consolidated Statements of Stockholders’ Equity for the three years ended December 31, 2016................................................
Consolidated Statements of Cash Flows for the three years ended December 31, 2016 ...............................................................
Notes to Consolidated Financial Statements .................................................................................................................................
Page
76
77
78
79
80
81
82
Other information is omitted because it is either presented elsewhere, is inapplicable or is immaterial as defined in the
instructions.
(b) Exhibits.
3.2(22)
3.1(22)
3.3(22)
Description of Exhibit
Exhibit Number
(cid:3)
Amended and Restated Certificate of Incorporation of Cerus Corporation.
(cid:3)
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.
(cid:3)
Certificate of Designation of Series C Junior Participating Preferred Stock of Cerus Corporation.
(cid:3)
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.
(cid:3)
Amended and Restated Bylaws of Cerus Corporation.
(cid:3)
Specimen Stock Certificate.
(cid:3)
Rights Agreement, dated as of November 3, 1999, as amended as of August 6, 2001, between Cerus Corporation and
4.2(14)
3.4(28)
3.5(8)
4.1(1)
Wells Fargo Bank, N.A. (formerly known as Norwest Bank Minnesota, N.A.).
(cid:3)
4.3(15)
(cid:3)
Amendment to Rights Agreement, dated as of October 28, 2009, between Cerus Corporation and Wells Fargo Bank,
N.A. (which includes the form of Rights Certificate as Exhibit B thereto).
(cid:3)
(cid:3)
(cid:3)
10.1(7)†
(cid:3)
Supply and/or Manufacturing Agreements
(cid:3)
Supply Agreement, dated December 19, 2007, by and between Cerus Corporation and Brotech Corporation d/b/a
Purolite Company.
10.2(29)†
Amended and Restated Supply Agreement, dated April 21, 2014, by and between Cerus Corporation and Purolite
Corporation.
(cid:3)
10.3(7)†
(cid:3)
Supply and Manufacturing Agreement, dated March 1, 2008, by and between Cerus Corporation and Porex
Corporation.
(cid:3)
10.4(23)†
(cid:3)
First Amendment to Supply and Manufacturing Agreement, dated November 28, 2012, by and between Cerus
Corporation and Porex Corporation.
10.5(30)†
Amendment #2 to Supply and Manufacturing Agreement, dated December 23, 2014, by and between Cerus
Corporation and Porex Corporation.
10.6
(cid:3)
Amendment #3 to Supply and Manufacturing Agreement, dated December 20, 2016, by and between Cerus
69
Exhibit Number
(cid:3)
Corporation and Porex Corporation.
Description of Exhibit
(cid:3)
10.7
(cid:3)
Amendment #4 to Supply and Manufacturing Agreement, dated January 31, 2017, by and between Cerus Corporation
and Porex Corporation.
10.8(34)†
(cid:3)
Amended and Restated Manufacturing and Supply Agreement, dated October 19, 2015, by and between Cerus
Corporation and Fresenius Kabi Deutschland GmbH.
(cid:3)
10.9(10)†
(cid:3)
Manufacturing and Supply Agreement, dated September 30, 2008, by and between Cerus Corporation and NOVA
Biomedical Corporation.
(cid:3)
(cid:3)
10.10(35)† Amendment #1 to the Manufacturing and Supply Agreement, dated March 15, 2016, by and between NOVA
Biomedical Corporation and Cerus Corporation.
(cid:3)
(cid:3)
10.11(19)† Amended and Restated Supply Agreement, dated as of September 1, 2011, between Cerus Corporation and Ash
Stevens Inc.
(cid:3)
(cid:3)
10.12(24)† Addendum 1 to Amended and Restated Supply Agreement, dated August 1, 2013, by and between Cerus Corporation
and Ash Stevens, Inc.
(cid:3)
Loan and Security Agreements
(cid:3)
(cid:3)
(cid:3)
(cid:3)
10.13(28)† Loan and Security Agreement, dated as of June 30, 2014, by and among Cerus Corporation and Oxford Finance LLC,
as collateral agent and a lender.
10.14(34)
(cid:3)
First Amendment to Loan and Security Agreement, dated January 30, 2015, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
(cid:3)
(cid:3)
10.15†(33) Second Amendment to Loan and Security Agreement, dated September 29, 2015, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
10.16(37)
Third Amendment to Loan and Security Agreement, dated July 28, 2016, by and among Cerus Corporation and Oxford
Finance LLC, as collateral agent and a lender.
10.17
(cid:3)
Fourth Amendment to Loan and Security Agreement, dated October 25, 2016, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
(cid:3)
(cid:3)
(cid:3)
10.18(4)
(cid:3)
Real Estate Lease Agreements
(cid:3)
Standard Industrial/Commercial Single-Tenant Lease-Net, dated October 12, 2001 between Cerus Corporation and
California Development, Inc.
(cid:3)
10.19(9)
(cid:3)
Second Amendment to Standard Industrial/Commercial Single-Tenant Lease-Net, dated as of September 18, 2008
between Cerus Corporation and California Development, Inc.
(cid:3)
10.20(16)
(cid:3)
Letter to California Development, Inc. exercising option to extend the lease term from the Second Amendment to
Standard Industrial/Commercial Single-Tenant Lease-Net, dated as of September 18, 2008 between Cerus Corporation
and California Development, Inc.
(cid:3)
10.21(25)
(cid:3)
Real Property Lease, dated June 20, 2013, between Cerus Corporation and S. P. Cuff as Managing Partner of the
Redwoods Business Center LP.
(cid:3)
10.22(31)
(cid:3)
Letter, dated March 13, 2015 to Cuff Property Management exercising option to extend the lease term under the Real
Property Lease, dated June 20, 2013, between Cerus Corporation and S. P. Cuff as Managing Partner of the Redwoods
Business Center LP.
(cid:3)
70
Exhibit Number
(cid:3)
Employment Agreements or Offer Letters
(cid:3)
(cid:3)
Description of Exhibit
10.23(18)* Employment Letter, by and between Cerus corporation and William M. Greenman, dated May 12, 2011.
(cid:3)
10.24(23)* Addendum to Employment Agreement for William M. Greenman, dated December 5, 2012.
(cid:3)
10.25(25)* Employment Letter, by and between Cerus Corporation and Laurence Corash, dated July 30, 2009.
(cid:3)
10.26(17)* Employment Letter, by and between Cerus Corporation and Laurence Corash, dated March 2, 2010.
(cid:3)
10.27(14)* Employment Letter for Kevin D. Green, dated May 1, 2009.
(cid:3)
10.28(23)* Employment Letter, by and between Cerus Corporation and Chrystal Menard, dated October 19, 2012.
(cid:3)
10.29(25)* Employment Letter, by and between Cerus Corporation and Carol Moore, dated December 14, 2007.
(cid:3)
10.30(33)* Employment Letter, by and between Cerus Corporation and Richard J. Benjamin MBChB, PhD, FRCPath, dated
May 12, 2015.
(cid:3)
10.31(34)* Settlement Agreement, by and between Cerus Europe B.V. and Caspar Hogeboom, dated December 23, 2015.
(cid:3)
10.32(34)* Consulting Agreement, by and between Cerus Corporation and Caspar Hogeboom, dated December 23, 2015
(cid:3)
10.33(37)* Employment Letter, by and between Cerus Corporation and Vivek Jayaraman, dated May 31, 2016.
(cid:3)
10.34(1)*
10.35(1)*
10.36(1)*
(cid:3)
Stock Plans and Related Forms
(cid:3)
1996 Equity Incentive Plan.
(cid:3)
Form of Incentive Stock Option Agreement under the 1996 Equity Incentive Plan.
(cid:3)
Form of Nonstatutory Stock Option Agreement under the 1996 Equity Incentive Plan.
(cid:3)
10.37(32)* Amended and Restated 1996 Employee Stock Purchase Plan, effective June 10, 2015.
10.38(2)*
10.39(3)*
10.40(5)*
(cid:3)
1998 Non-Officer Stock Option Plan.
(cid:3)
1999 Equity Incentive Plan, adopted April 30, 1999, approved by stockholders July 2, 1999.
(cid:3)
1999 Non-Employee Directors’ Stock Option Sub-Plan, amended December 4, 2002.
(cid:3)
10.41(32)* Amended and Restated 2008 Equity Incentive Plan, effective June 10, 2015.
(cid:3)
10.42(20)* Form of Option Agreement for employees under the Amended and Restated 2008 Equity Incentive Plan.
(cid:3)
10.43(20)* Form of Option Agreement for non-employee directors under the Amended and Restated 2008 Equity Incentive Plan.
(cid:3)
10.44(20)* Form of Restricted Stock Unit Agreement under the Amended and Restated 2008 Equity Incentive Plan.
(cid:3)
10.45(36)* Cerus Corporation Inducement Plan.
(cid:3)
10.46(36)* Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Cerus Corporation
Inducement Plan.
(cid:3)
(cid:3)
10.47(36)* Form of Restricted Stock Unit Grant Notice and Restricted Stock Award Agreement under the Cerus Corporation
Inducement Plan.
71
Exhibit Number
(cid:3)
(cid:3)
Other Compensatory Plans or Agreements
(cid:3)
(cid:3)
Description of Exhibit
10.48(23)* Bonus Plan for Senior Management of Cerus Corporation, as amended December 5, 2012.
(cid:3)
10.49(11)* Cerus Corporation Change of Control Severance Benefit Plan, as amended.
(cid:3)
10.50(13)* Form of Severance Benefits Agreement.
(cid:3)
10.51(26)* Amended and Restated Non-Employee Director Compensation Policy.
(cid:3)
10.52(35)* 2015 and 2016 Executive Officer Compensation Arrangements.
(cid:3)
10.53(1)
10.54(12)
10.55(21)
(cid:3)
Other Material Agreements
(cid:3)
Form of Indemnity Agreement entered into between Cerus Corporation and each of its directors and executive officers.
(cid:3)
Form of Amended and Restated Indemnity Agreement, adopted April 24, 2009.
(cid:3)
Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, by and between Cerus Corporation and
Cantor Fitzgerald & Co.
10.56(27)
Amendment No 1. to Controlled Equity OfferingSM Sales Agreement, dated March 21, 2014, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
(cid:3)
10.57(35)
(cid:3)
Amendment No. 2 to Controlled Equity OfferingSM Sales Agreement, dated May 5, 2016, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
(cid:3)
(cid:3)
10.58(16)† Restructuring Agreement, dated as of February 2, 2005, by and among Cerus Corporation, Baxter Healthcare S.A. and
Fresenius Kabi AG (successor-in-interest to Baxter Healthcare Corporation).
(cid:3)
(cid:3)
10.59(16)† License Agreement, dated as of February 2, 2005, by and between Cerus Corporation and Fresenius Kabi AG
(successor-in-interest to Baxter Healthcare S.A. and Baxter Healthcare Corporation).
10.60(6)†
Commercialization Transition Agreement, dated as of February 12, 2006, by and between Cerus Corporation and
Fresenius Kabi AG (successor-in-interest to Baxter Healthcare S.A. and Baxter Healthcare Corporation).
12.1
21.1
23.1
24.1
31.1
(cid:3)
Computation of Earnings to Fixed Charges.
(cid:3)
List of Registrant’s subsidiaries.
(cid:3)
Consent of Independent Registered Public Accounting Firm.
(cid:3)
Power of Attorney (see signature page).
(cid:3)
Certification of the Principal Executive Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
31.2
(cid:3)
Certification of the Principal Financial Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002.
32.1(38)
(cid:3)
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002.
101.INS
101.SCH
(cid:3)
XBRL Instance Document
(cid:3)
XBRL Taxonomy Extension Schema Document
72
Description of Exhibit
101.CAL
Exhibit Number
(cid:3)
(cid:3)
XBRL Taxonomy Extension Calculation Linkbase Document
(cid:3)
XBRL Taxonomy Extension Definition Linkbase Document
(cid:3)
XBRL Taxonomy Extension Label Linkbase Document
(cid:3)
XBRL Taxonomy Extension Presentation Linkbase Document
101.LAB
101.DEF
101.PRE
†
*
(1)
(2)
(3)
(4)
(5)
Certain portions of this exhibit are subject to a confidential treatment order.
(cid:3)
Compensatory Plan.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-1 (File
No. 333-11341) and amendments thereto.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-8, dated
March 24, 1999.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-8, dated
August 4, 1999.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2001.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2003.
(6)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2006.
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on June 19, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on April 30, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on June 1, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended June 30, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
73
SEC on October 30, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on March 8, 2010.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on May 18, 2011.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2011.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on August 31, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2013.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2013.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on March 21, 2014.
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(26)
(27)
(28)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended June 30, 2014.
(29)
(30)
(31)
(32)
(33)
(34)
(cid:3)
Incorporated by reference to the like-described exhibit to Amendment No. 1 to the Registrant’s Quarterly Report on
Form 10-Q/A, for the quarter ended June 30, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Annual Report on Form 10-K, for the year ended
December 31, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant's Annual Report on Form 10-K, for the year ended
December 31, 2015.
74
(35)
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant's Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2016.
(36)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K (File No. 000-
21937), filed with the SEC on August 31, 2016.
(37)
Incorporated by reference to the like-described exhibit to Registrant's Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2016.
(38)
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange
Commission, and is not incorporated by reference into any filing of the Registrant’s under the Securities Act of 1933,
as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form
10-K), irrespective of any general incorporation language contained in such filing.
75
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of Cerus Corporation
We have audited the accompanying consolidated balance sheets of Cerus Corporation as of December 31, 2016 and 2015, and the
related consolidated statements of operations, comprehensive loss, stockholders’ equity and cash flows for each of the three years in
the period ended December 31, 2016. These financial statements are the responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of
Cerus Corporation at December 31, 2016 and 2015, and the consolidated results of its operations and its cash flows for each of the
three years in the period ended December 31, 2016, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Cerus
Corporation’s internal control over financial reporting as of December 31, 2016, based on criteria established in Internal Control –
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our
report dated March 8, 2017 expressed an unqualified opinion thereon.
/s/ ERNST & YOUNG LLP
Redwood City, California
March 8, 2017
76
CERUS CORPORATION
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
Current assets:
ASSETS
Cash and cash equivalents ............................................................................................... $
Short-term investments ....................................................................................................
Investment in marketable equity securities ......................................................................
Accounts receivable .........................................................................................................
Inventories .......................................................................................................................
Prepaid expenses..............................................................................................................
Other current assets .........................................................................................................
Total current assets .....................................................................................................
Non-current assets:
Property and equipment, net ............................................................................................
Goodwill ..........................................................................................................................
Intangible assets, net ........................................................................................................
Restricted cash .................................................................................................................
Other assets ......................................................................................................................
Total assets ................................................................................................................. $
Current liabilities:
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable ............................................................................................................. $
Accrued liabilities ............................................................................................................
Manufacturing and development obligations - current ....................................................
Debt - current ...................................................................................................................
Deferred product revenue - current ..................................................................................
Total current liabilities ...............................................................................................
Non-current liabilities:
Debt - non-current ...........................................................................................................
Deferred income taxes .....................................................................................................
Manufacturing and development obligations - non-current .............................................
Other non-current liabilities .............................................................................................
Total liabilities ...........................................................................................................
Commitments and contingencies
Stockholders' equity:
December 31,
2016
2015
22,560 $
45,116
3,952
6,868
12,531
1,274
1,804
94,105
2,985
1,316
738
184
4,148
103,476 $
8,587 $
11,218
—
6,934
149
26,888
12,441
150
4,770
1,440
45,689
71,018
25,698
11,163
5,794
10,812
1,166
4,755
130,406
3,549
1,316
940
612
2,579
139,402
5,217
9,853
3,282
2,956
554
21,862
16,848
122
4,542
1,263
44,637
Preferred stock, $0.001 par value; 5,000 shares authorized, issuable in series; zero
shares issued and outstanding at December 31, 2016 and 2015, respectively ..............
Common stock, $0.001 par value; 225,000 shares authorized; 103,475 and 99,095
shares issued and outstanding at December 31, 2016 and 2015, respectively ..............
Additional paid-in capital ................................................................................................
Accumulated other comprehensive income .....................................................................
Accumulated deficit .........................................................................................................
Total stockholders' equity ..........................................................................................
Total liabilities and stockholders' equity ............................................................... $
—
—
103
718,299
103
(660,718 )
57,787
103,476 $
99
685,189
7,289
(597,812)
94,765
139,402
See accompanying Notes to Consolidated Financial Statements.
77
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
2016
Year Ended December 31,
2015
2014
Product revenue ................................................................................................ $
Cost of product revenue ....................................................................................
Gross profit on product revenue ..................................................................
Government contracts revenue ..........................................................................
Operating expenses:
Research and development ..........................................................................
Selling, general and administrative ..............................................................
Amortization of intangible assets ................................................................
Impairment of long-lived assets ...................................................................
Total operating expenses ........................................................................
Loss from operations .........................................................................................
Non-operating (expense) income, net:
Gain from revaluation of warrant liability ...................................................
Foreign exchange gain (loss) .......................................................................
Interest expense ...........................................................................................
Other income, net ........................................................................................
Total non-operating (expense) income, net .......................................................
Loss before income taxes ..................................................................................
Provision (benefit) for income taxes .................................................................
Net loss ........................................................................................................ $
37,183 $
20,295
16,888
2,092
31,322
48,753
202
150
80,427
(61,447)
—
21
(2,445)
1,140
(1,284)
(62,731)
175
(62,906) $
34,223 $
23,464
10,759
—
25,643
45,989
202
—
71,834
(61,075)
3,566
(396)
(1,705)
71
1,536
(59,539)
(3,671)
(55,868) $
Net loss per share:
Basic ............................................................................................................ $
Diluted .........................................................................................................
Weighted average shares outstanding used for calculating net loss per share:
Basic ............................................................................................................
Diluted .........................................................................................................
(0.62) $
(0.62)
(0.58) $
(0.61)
101,826
101,826
96,068
96,905
See accompanying Notes to Consolidated Financial Statements.
36,416
21,188
15,228
—
21,800
37,729
202
—
59,731
(44,503)
7,708
(1,296)
(599)
130
5,943
(38,560)
195
(38,755)
(0.52)
(0.61)
74,767
76,534
78
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Net loss ............................................................................................................. $
Other comprehensive (loss) income:
Unrealized (losses) gains on available-for-sale investments, net of taxes
of zero, $3,825 and zero for 2016, 2015, and 2014, respectively ...................
Comprehensive loss .......................................................................................... $
2016
Year Ended December 31,
2015
2014
(62,906) $
(55,868) $
(38,755)
(7,186)
(70,092) $
7,320
(48,548) $
(38)
(38,793)
See accompanying Notes to Consolidated Financial Statements.
79
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
Common Stock
Shares
Amount
4,341
Balance at December 31, 2013 .................................... 71,859 $
—
Net loss .......................................................................
—
Other comprehensive loss ...........................................
Issuance of common stock from public offering, net
of offering costs .......................................................
Issuance of common stock from exercise of stock
4,204
options and warrants, and purchases from ESPP .....
Stock-based compensation ..........................................
—
Balance at December 31, 2014 .................................... 80,404
—
Net loss .......................................................................
—
Other comprehensive income ......................................
Issuance of common stock from public offering, net
of offering costs ....................................................... 14,636
Issuance of common stock from exercise of stock
options and warrants, and purchases from ESPP .....
4,055
—
Stock-based compensation ..........................................
Balance at December 31, 2015 .................................... 99,095
—
Net loss .......................................................................
Other comprehensive loss ...........................................
—
Issuance of common stock from public offering, net
of offering costs .......................................................
Issuance of common stock from exercise of stock
854
options and purchases from ESPP ............................
—
Stock-based compensation ..........................................
Balance at December 31, 2016 .................................... 103,475 $
3,526
Additional
Paid-in
Capital
72 $ 545,905 $
—
—
—
—
Accumulated
Other
Comprehensive Accumulated
Income (Loss) Deficit
Total
Stockholders'
Equity
7 $ (503,189) $
(38,755)
—
—
(38 )
42,795
(38,755)
(38)
4
18,517
—
—
18,521
13,841
4
—
5,153
80 583,416
—
—
—
—
—
—
—
—
(31 ) (541,944)
(55,868)
—
—
7,320
13,845
5,153
41,521
(55,868)
7,320
15
75,361
—
—
75,376
4
19,682
6,730
—
99 685,189
—
—
—
—
—
—
—
—
7,289 (597,812)
(62,906)
—
—
(7,186 )
19,686
6,730
94,765
(62,906)
(7,186)
3
21,978
—
—
21,981
1
—
3,067
8,065
103 $ 718,299 $
—
—
—
—
103 $ (660,718) $
3,068
8,065
57,787
See accompanying Notes to Consolidated Financial Statements.
80
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Operating activities
Net loss ............................................................................................................. $
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization .....................................................................
Stock-based compensation...........................................................................
Changes in valuation of warrant liability .....................................................
Non-cash interest expense ...........................................................................
Non-cash deferred manufacturing and development expense .....................
Deferred income taxes .................................................................................
Loss on disposal of fixed assets ...................................................................
Impairment of long-lived assets ...................................................................
Non-cash tax benefit from other unrealized gain on
available-for-sale securities ......................................................................
Gain on sale of investment in marketable equity securities .........................
Changes in operating assets and liabilities:
Accounts receivable .....................................................................................
Inventories ...................................................................................................
Other assets ..................................................................................................
Accounts payable .........................................................................................
Accrued liabilities ........................................................................................
Manufacturing and development obligations...............................................
Deferred product revenue ............................................................................
Net cash used in operating activities .................................................................
Investing activities
Capital expenditures ....................................................................................
Proceeds from sale of fixed assets ...............................................................
Purchases of investments .............................................................................
Proceeds from maturities and sale of investments .......................................
Net cash (used in) provided by investing activities ...........................................
Financing activities
Net proceeds from equity incentives and warrants ......................................
Net proceeds from public offering ...............................................................
Proceeds from loans .....................................................................................
Repayment of debt .......................................................................................
Net cash provided by financing activities .........................................................
Net (decrease) increase in cash, cash equivalents and restricted cash .........
Cash, cash equivalents and restricted cash, beginning of year ..........................
Cash, cash equivalents and restricted cash, end of year .................................... $
Supplemental disclosures:
Cash paid for interest ................................................................................... $
Cash paid for income taxes ..........................................................................
Unpaid manufacturing and development obligation ....................................
2016
Year Ended December 31,
2015
2014
(62,906) $
(55,868) $
(38,755)
1,817
8,065
—
1,017
—
28
—
150
—
(750)
(1,074)
(1,781)
1,327
3,261
1,330
(3,568)
(445)
(53,529)
(563)
—
(82,811)
63,450
(19,924)
3,068
22,121
—
(622)
24,567
(48,886)
71,630
22,744 $
1,366 $
157
—
1,699
6,730
(3,566)
508
434
7
—
—
(3,825)
—
(301)
3,991
1,379
(3,866)
1,359
—
190
(51,129)
(722)
—
(90,407)
92,645
1,516
12,767
75,300
10,000
(113)
97,954
48,341
23,289
71,630 $
1,087 $
153
7,051
1,415
5,153
(7,708)
131
—
26
3
—
—
—
632
3,033
(1,655)
(973)
(1,382)
—
269
(39,811)
(2,106)
25
(25,981)
24,915
(3,147)
11,592
18,488
9,848
(3,474)
36,454
(6,504)
29,793
23,289
563
177
—
See accompanying Notes to Consolidated Financial Statements.
81
CERUS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
Note 1. Nature of Operations and Basis of Presentation
Cerus Corporation (the “Company”) was incorporated in September 1991 and is developing and commercializing the INTERCEPT
Blood System, which is designed to enhance the safety of blood components through pathogen reduction. The Company has
worldwide commercialization rights for the INTERCEPT Blood System for platelets, plasma and red blood cells.
The Company sells its INTERCEPT platelet and plasma systems in the United States of America (“U.S.”), Europe, the
Commonwealth of Independent States (“CIS”) countries, the Middle East and selected countries in other regions around the world.
The Company conducts significant research, development, testing and regulatory compliance activities on its product candidates that,
together with anticipated selling, general, and administrative expenses, are expected to result in substantial additional losses, and the
Company may need to adjust its operating plans and programs based on the availability of cash resources. The Company’s ability to
achieve a profitable level of operations will depend on successfully completing development, obtaining additional regulatory
approvals and achieving widespread market acceptance of its products. There can be no assurance that the Company will ever achieve
a profitable level of operations.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V.
(together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and
transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted
in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).
Use of Estimates
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported
amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis,
management evaluates its estimates, including those related to the accounts receivable, inventory reserves, fair values of investments,
stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes,
and accrued liabilities, among others. We base our estimates on historical experience, future projections, and on various other
assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different
assumptions or conditions.
Revenue
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue
Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of the
arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and
(iv) collectability is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2016, 2015 and
2014, were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or
“disposable kits”) and UVA illumination devices (“illuminators”).
Revenue related to product sales is generally recognized when the Company fulfills its obligations for each element of an agreement.
For all sales of the Company’s INTERCEPT Blood System products, the Company uses a binding purchase order or signed sales
contract as evidence of an arrangement. The Company sells its platelet and plasma systems directly to blood banks, hospitals,
universities, government agencies, as well as to distributors in certain regions. Generally, the Company’s contracts with its customers
do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming
product. Deliverables and the units of accounting vary according to the provisions of each purchase order or sales contract. For
revenue arrangements with multiple elements, the Company determines whether the delivered elements meet the criteria as separate
units of accounting. Such criteria require that the deliverable have stand-alone value to the customer and that if a general right of
return exists relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially
in the control of the Company. Once the Company determines if the deliverable meets the criteria for a separate unit of accounting, the
Company must determine how the consideration should be allocated between the deliverables and how the separate units of
accounting should be recognized as revenue. Consideration received is allocated to elements that are identified as discrete units of
82
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
accounting. Because the Company has no vendor specific objective evidence or third party evidence for its systems due to the
Company’s variability in its pricing across the regions into which it sells its products, the allocation of revenue is based on best
estimated selling price for the products sold. The objective of best estimated selling price is to determine the price at which the
Company would transact a sale, had the product been sold on a stand-alone basis. The Company determines best estimated selling
price for its systems by considering multiple factors. The Company regularly reviews best estimated selling price. At December 31,
2016 and 2015, the Company had $0.1 million and $0.6 million, respectively, of short-term deferred revenue on its consolidated
balance sheets related to future performance obligations. At each of December 31, 2016 and 2015, the Company had $0.1 million of
long-term deferred revenue included in “Other non-current liabilities” on it consolidated balance sheets related to future performance
obligations. Freight costs charged to customers are recorded as a component of revenue. Taxes that the Company invoices to its
customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue.
The Company receives reimbursement under its U.S. government contract that supports research and development of defined projects.
The contract generally provides for reimbursement of approved costs incurred under the terms of the applicable contract. Revenue
related to the cost reimbursement provisions under U.S. government contract are recognized as the qualified direct and indirect costs
on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government
contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to revenue
previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet
audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to
services performed under the contract are included as a component of research and development or selling, general and administrative
expenses in the Company’s consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for
government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and
government contract.
Research and Development Expenses
In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development (“R&D”)
expenses are charged to expense when incurred, including cost incurred pursuant to the terms of any contract that has been awarded to
the Company by the U.S. government. Research and development expenses include salaries and related expenses for scientific and
regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities,
depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory
studies, process development and product manufacturing for research use.
The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts
of R&D expenses recorded from development funding and government contract. Actual results may differ from those estimates under
different assumptions or conditions.
Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be
classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-
sale.
Investments
Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency
securities, and marketable equity securities of Aduro Biotech, Inc. (“Aduro”) are designated as available-for-sale and classified as
short-term investments or investment in marketable equity securities, in accordance with ASC Topic 320, “Accounting for Certain
Investments in Debt and Equity Securities”. Available-for-sale securities are carried at estimated fair value. The Company views its
available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the
estimated fair value of available-for-sale securities were recorded in “Net unrealized (losses) gains on available-for-sale investments,
net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-
sale investments were recorded in “Other income, net” on the Company’s consolidated statements of operations. The costs of
securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium
and accretion of any discount resulting from the purchase of debt securities as a component of interest income.
83
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
The Company also reviews its available-for-sale securities on a regular basis to evaluate whether any security has experienced an
other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net”
on the Company’s consolidated statements of operations.
Restricted Cash
Prior to December 31, 2016, the Company held a certificate of deposit with a domestic bank for any potential decommissioning
resulting from the Company’s possession of radioactive material. The certificate of deposit was held to satisfy the financial surety
requirements of the California Department of Health Services and was recorded in “Restricted cash” on the Company’s condensed
consolidated balance sheets at December 31, 2015. As of December 31, 2016, the Company also had certain non-U.S. dollar
denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents,
available-for-sale securities and accounts receivable.
Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and available-for-sale
securities are maintained at major financial institutions of high credit standing. The Company monitors the financial credit worthiness
of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its
investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its
investment policy. At December 31, 2016, the fair value of the Company’s marketable equity securities of Aduro is subject to the
underlying volatility of Aduro’s stock price. At December 31, 2016, the Company does not believe there is significant financial risk
from non-performance by the issuers of the Company’s cash equivalents and short-term investments.
Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company
performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not
require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or
customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable
on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general
and administrative expenses.
The Company had three customers that accounted for more than 10% of the Company’s outstanding trade receivables at both
December 31, 2016 and 2015. These customers cumulatively represented approximately 46% and 49% of the Company’s outstanding
trade receivables at December 31, 2016 and 2015, respectively. To date, the Company has not experienced collection difficulties from
these customers.
Inventories
At December 31, 2016 and 2015, inventory consisted of work-in-process and finished goods only. Finished goods include
INTERCEPT disposable kits, illuminators, and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable
kits generally have a two-year life from the date of manufacture. Illuminators and replacement parts do not have regulated expiration
dates. Work-in-process includes certain components that are manufactured over a protracted length of time before being sold to, and
ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH or Fresenius, Inc. (with their affiliates, “Fresenius”) into
the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at
each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of
finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the
Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead
times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ
from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2016
and 2015, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its
evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective
subsequent twelve-month period.
84
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or net realizable value. The Company uses
significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently
reviews such determinations. The Company writes down specifically identified unusable, obsolete, slow-moving, or known unsalable
inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration
dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost
basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs
associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of
operations. At December 31, 2016, and 2015, the Company had $0.2 million and $1.8 million, respectively, recorded for potential
obsolete, expiring or unsalable product.
Property and Equipment, net
Property and equipment is comprised of furniture, equipment, leasehold improvements, construction-in-progress, information
technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is
depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five years). Leasehold
improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the
improvements.
Capitalization of Software Costs
The Company capitalizes certain significant costs incurred in the acquisition and development of software for internal use, including
the costs of the software, materials, and consultants during the application development stage. Costs incurred prior to the application
development stage, costs incurred once the application is substantially complete and ready for its intended use, and other costs not
qualifying for capitalization, including training and maintenance costs, are charged to expense as incurred.
Goodwill and Intangible Assets, net
Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to
ratable amortization over the original estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is
recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations. Goodwill is not amortized
but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances
indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if
indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is
more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more
likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing
the quantitative two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further
testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed
directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for
impairment in any subsequent period. The first step of the two-step process compares the fair value of each reporting unit with its
respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the
fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the
Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets
to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic
environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the
reporting unit is not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the
two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s
goodwill, based on the present value of future cash flows, with the respective carrying amount of that goodwill. If the carrying amount
of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal
to that excess.
The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and
Equipment,” if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may
not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the
excess amount of the carrying value of the intangible assets over its fair value. For further details regarding the impairment analysis,
85
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
reference is made to the section below under “Long-lived Assets.” See Note 7 for further information regarding the Company’s
impairment analysis and the valuation of goodwill and intangible assets, net.
Long-lived Assets
The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could
indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the
Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted
expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the
Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the
assets.
Foreign Currency Remeasurement
The functional currency of the Company’s foreign subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign
currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities
denominated in foreign currencies are remeasured in U.S. dollars using historical exchange rates. Revenues and expenses are
remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated
statements of operations.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation - Stock Compensation.
Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on
a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the
extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance
criteria are probable of being achieved.
For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, Equity Based Payment to Non-Employees
and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at
which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s
performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the
non-employee stock-based awards in its consolidated statements of operations.
See Note 13 for further information regarding the Company’s stock-based compensation assumptions and expenses.
Income Taxes
The Company accounts for income taxes using an asset and liability approach in accordance with ASC Topic 740, Accounting for
Income Taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial
reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the
differences are expected to reverse. ASC Topic 740 requires derecognition of tax positions that do not have a greater than 50%
likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation
allowance as described in ASC Topic 740 is not an appropriate substitute for derecognition of a tax position. The Company recognizes
accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized
any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and
penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions,
there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The
Company’s U.S. federal tax returns from 1998 through 2015 and California tax returns through 2015 remain subject to examination by
the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a full valuation
allowance on all of its net deferred tax assets, except for its indefinite lived intangibles.
86
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the
period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding for the period. The potentially
dilutive securities include stock options, employee stock purchase plan rights, warrants and restricted stock units, which are calculated
using the treasury stock method. Diluted net loss per share also gives effect to potential adjustments to the numerator for gains
resulting from the revaluation of warrants to fair value for the period, even if the Company is in a net loss position if the effect would
result in more dilution.
Certain potential dilutive securities were excluded from the dilution calculation for the years ended December 31, 2016, 2015 and
2014, as their inclusion would have been anti-dilutive.
The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net
loss per share for the years ended December 31, 2016, 2015 and 2014 (in thousands, except per share amounts):
Year Ended December 31,
2015
2014
2016
Numerator for Basic and Diluted:
Net loss used for basic calculation ...................................... $
Effect of revaluation of warrant liability .............................
Adjusted net loss used for dilution calculation .................... $
(62,906) $
—
(62,906) $
(55,868 ) $
(3,566 )
(59,434 ) $
(38,755)
(7,708)
(46,463)
Denominator:
Basic weighted average number of shares outstanding .......
Effect of dilutive potential shares ........................................
Diluted weighted average number of shares outstanding ....
101,826
—
101,826
96,068
837
96,905
74,767
1,767
76,534
Net loss per share:
Basic .................................................................................... $
Diluted .................................................................................
(0.62) $
(0.62)
(0.58 ) $
(0.61 )
(0.52)
(0.61)
The table below presents shares underlying stock options and restricted stock units that were excluded from the calculation of the
weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the
calculation due to their anti-dilutive effect for the years ended December 31, 2016, 2015 and 2014 (shares in thousands):
Weighted average number of anti-dilutive potential shares:
Stock options .................................................................................
Restricted stock units ....................................................................
Total ........................................................................................
Year Ended December 31,
2015
2014
2016
15,592
576
16,168
13,681
—
13,681
11,722
—
11,722
Guarantee and Indemnification Arrangements
The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In
addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has
occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under
those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the
counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of
a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The
Company has not received any such requests for indemnification under these provisions and has not been required to make material
payments pursuant to these provisions.
The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in
materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are
estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty
claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2016 and 2015.
87
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Fair Value of Financial Instruments
The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts
receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based
on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt
approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a
recurring basis, including its available-for-sale securities and warrant liability prior to the expiration and exercise of the warrants in
November 2015. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical
assets, which include the Company’s cash accounts and money market funds. The Company classifies instruments in Level 2 if the
instruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or
alternative pricing sources with reasonable levels of price transparency. These instruments include the Company’s corporate debt and
U.S. government agency securities holdings. The available-for-sale securities are held by a custodian who obtains investment prices
from a third party pricing provider that uses standard inputs (observable in the market) to models which vary by asset class. The
Company classifies instruments in Level 3 if one or more significant inputs or significant value drivers are unobservable. The
Company assesses any transfers among fair value measurement levels at the end of each reporting period.
See Notes 3 for further information regarding the Company’s valuation of financial instruments.
New Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers
(Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with
customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is
recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity
expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount,
timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in
judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU No. 2015-
14, Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date, which defers by one year the effective date of
ASU No. 2014-09 to annual reporting periods beginning after December 15, 2017 (including interim periods within those periods).
Early adoption is permitted to the original effective date of December 15, 2016 (including interim periods within those periods). In
March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent
Considerations (Reporting Revenue Gross versus Net), which clarifies how to identify the unit of accounting for the principal versus
agent evaluation and how to apply the control principle to certain types of arrangements. In April 2016, the FASB issued ASU No.
2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies
the implementation guidance on identifying performance obligations and licensing. In May 2016, the FASB issued ASU No. 2016-12,
Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which addresses certain
issues on assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract
modifications at transition. In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic
606, Revenue from Contracts with Customers, which makes technical corrections and improvements to the new revenue standard.
These ASUs will be effective for the Company in the first quarter of fiscal year 2018, using one of two retrospective application
methods. The Company plans to adopt this ASU on January 1, 2018, using the modified retrospective approach. As part of the
Company’s assessment work to-date, it has formed an implementation work team to assess what impact the provisions of ASU 2014-
09, if any, may have on the Company’s financial position and results of operations. As part of its evaluation, the Company’s work
team plans to complete a review of contracts in accordance with ASU 2014-09. Additionally, the Company will continue to monitor
industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession as an ongoing
component of its assessment and implementation plans.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40):
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate, in
connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events,
considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after
the date that the financial statements are issued and provide related disclosures. The standard is effective for annual periods ending
after December 15, 2016, and interim periods thereafter. The Company has adopted this ASU effective for annul period ended
December 31, 2016, and has not noted any conditions and events, considered in the aggregate, that raise substantial doubt about the
Company’s ability to continue as a going concern within one year after the date that these financial statements are issued.
88
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of
Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a
direct deduction from the corresponding debt liability rather than as an asset. The Company has adopted this ASU effective January 1,
2016 under the retrospective application method. To conform to the current period presentation, the Company reclassified $32,000 and
$36,000, which were previously included in Other current assets and Other assets, respectively, in the Company’s condensed
consolidated balance sheet as of December 31, 2015, as a reduction of Debt-current and Debt-non-current, respectively. As a result of
the reclassifications, Other current assets and Debt-current decreased by $32,000, and Other assets and Debt- non-current decreased by
$36,000, in the Company’s consolidated balance sheet as of December 31, 2015.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity
investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for
under equity method of accounting or those that result in consolidation of the investee). The amendments also require an entity to
present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change
in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value
option for financial instruments. In addition, this ASU eliminates the requirement to disclose the fair value of financial instruments
measured at amortized cost for entities that are not public business entities and the requirement to disclose the method(s) and
significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized
cost on the balance sheet for public business entities. The standard is effective for annual periods beginning after December 15, 2017,
and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard
and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-
use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also
requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally
straight-line basis. The standard is effective for annual periods beginning after December 15, 2018, and interim periods thereafter,
with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the
future impact of this ASU on its consolidated financial statements. The Company anticipates the new guidance could significantly
impact the Company’s consolidated financial statements.
In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718):Improvements to Employee
Share-Based Payment Accounting, which requires entities to record all excess tax benefits and tax deficiencies as income tax expense
or benefit in the income statement when awards vest or are settled, and eliminates additional paid-in capital pools. The ASU also
changes the accounting for an employee’s use of shares to satisfy the employer’s statutory income tax withholding obligation, and the
accounting for forfeitures, and provides two practical expedients for nonpublic entities. The standard is effective for annual periods
beginning after December 15, 2016, and interim periods thereafter, with early application permitted. The Company will adopt this
ASU in 2017 and does not expect adoption to have a material impact on the Company’s consolidated financial statements.
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses
on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets held. The
standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application
permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this
ASU on the Company’s consolidated financial statements.
In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, a consensus of the
FASB Emerging Issues Task Force, which requires the statement of cash flows explain the change during the period in the total of
cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. The standard is effective for
annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The Company has
early adopted this ASU in 2016 under the retrospective application method to each period presented.
In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for
Goodwill Impairment, which modifies the goodwill impairment to be the amount by which a reporting unit’s carrying value exceeds
its fair value, not to exceed the carrying amount of goodwill, and removes the hypothetical purchase price allocation in the goodwill
impairment test. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with
early application permitted for impairment tests performed after January 1, 2017. The Company anticipates early adoption of the new
standard for impairment tests to be performed in 2017.
89
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Note 3. Fair Value on Financial Instruments
The Company uses certain assumptions that market participants would use to determine the fair value of an asset or liability in pricing
the asset or liability in an orderly transaction between market participants at the measurement date. The identification of market
participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A fair value
hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using
unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows:
(cid:120)
(cid:120)
(cid:120)
Level 1: Quoted prices in active markets for identical instruments
Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments)
Level 3: Significant unobservable inputs (including assumptions in determining the fair value of certain investments)
Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments
are readily available and can be independently validated as of the measurement date. This approach results in the classification of
these securities as Level 1 of the fair value hierarchy.
To estimate the fair value of Level 2 debt securities as of December 31, 2016, the Company’s primary service relies on inputs from
multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and U.S. government agency
securities are systematically priced by this service as of the close of business each business day. If the primary pricing service does
not price a specific asset a secondary pricing service is utilized.
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2016 (in
thousands):
Balance sheet
classification
Total
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Money market funds ..................................... (cid:3) Cash and cash equivalents $
United States government agency securities . (cid:3) Short-term investments
Corporate debt securities ............................... (cid:3) Short-term investments
Marketable equity securities ......................... Marketable equity securities
$
Total financial assets ...............................
8,991 $
8,029
37,087
3,952
58,059 $
8,991 $
—
—
3,952
12,943 $
— $
8,029
37,087
—
45,116 $
—
—
—
—
—
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2015 (in
thousands):
Balance sheet
classification
Total
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Money market funds ..................................... (cid:3) Cash and cash equivalents $
Corporate debt securities ............................... Short-term investments
Marketable equity securities ......................... (cid:3) Marketable equity securities
$
Total financial assets ...............................
59,302 $
25,698
11,163
96,163 $
59,302 $
—
11,163
70,465 $
— $
25,698
—
25,698 $
—
—
—
—
90
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
A reconciliation of the beginning and ending balances for the warrant liability using significant unobservable inputs (Level 3) from
December 31, 2014 to December 31, 2015, was as follows (in thousands):
Balance at December 31, 2014 ..................................................... $
Decrease in fair value of warrants ................................................
Settlement of warrants exercised ..................................................
Balance at December 31, 2015 ..................................................... $
10,485
(3,566 )
(6,919 )
—
The Company did not have any outstanding warrants during 2016. See Notes 2 and 12 for further information regarding the
Company’s valuation techniques and unobservable inputs for the warrant liability using significant unobservable inputs (Level 3).The
Company did not have any transfers among fair value measurement levels during the years ended December 31, 2016 and 2015.
Note 4. Available-for-sale Securities
The following is a summary of available-for-sale securities at December 31, 2016 (in thousands):
December 31, 2016
Money market funds ......................................................... $
United States government agency securities .....................
Corporate debt securities ...................................................
Marketable equity securities .............................................
Total available-for-sale securities ................................ $
8,991 $
8,030
37,110
—
54,131 $
Amortized
Cost
Gross
Unrealized Gain
Gross
Unrealized Loss Fair Value
— $
(1 )
(23 )
—
(24 ) $
8,991
8,029
37,087
3,952
58,059
— $
—
—
3,952
3,952 $
The following is a summary of available-for-sale securities at December 31, 2015(in thousands):
December 31, 2015
Money market funds ......................................................... $
Corporate debt securities ...................................................
Marketable equity securities .............................................
Total available-for-sale securities ................................ $
Amortized
Cost
59,302 $
25,747
—
85,049 $
Gross
Unrealized Gain
Gross
— $
—
11,163
11,163 $
Unrealized Loss Fair Value
— $
(49 )
—
(49 ) $
59,302
25,698
11,163
96,163
Available-for-sale securities at December 31, 2016 and 2015, consisted of the following by contractual maturity (in thousands):
One year or less ....................................................................... $
Marketable equity securities ....................................................
Greater than one year and less than five years ........................
Total available-for-sale securities ...................................... $
54,131 $
—
—
54,131 $
54,107 $
3,952
—
58,059 $
85,049 $
—
—
85,049 $
85,000
11,163
—
96,163
December 31, 2016
December 31, 2015
Amortized
Cost
Fair Value
Amortized
Cost
Fair Value
91
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary
impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and
length of time that individual securities have been in a continuous unrealized loss position (in thousands):
(cid:3)
(cid:3)(cid:3)
(cid:3)(cid:3)
(cid:3)
(cid:3)(cid:3)
(cid:3)(cid:3)
(cid:3)(cid:3)
(cid:3)(cid:3)
(cid:3)(cid:3)
Money market funds ............... $
United States government
agency securities ..................
Corporate debt securities ........
Total available-for-sale
securities ......................... $
(cid:3)(cid:3)
(cid:3)(cid:3)
(cid:3)(cid:3)
Money market funds ............... $
United States government
agency securities ..................
Corporate debt securities ........
Total available-for-sale
securities ......................... $
Less than 12 Months
Fair Value
Unrealized Loss
Fair Value
December 31, 2016
12 Months or Greater
(cid:3)(cid:3)
Unrealized Loss (cid:3)(cid:3)
— $
— $
— $
6,035
34,086
(1)
(23)
—
—
— (cid:3)(cid:3) $
— (cid:3)(cid:3)
— (cid:3)(cid:3)
Fair Value
Total
Unrealized Loss
—
— $
6,035
34,086
40,121 $
(24) $
— $
— (cid:3)(cid:3) $
40,121 $
Less than 12 Months
Fair Value
Unrealized Loss
Fair Value
December 31, 2015
12 Months or Greater
(cid:3)(cid:3)
Unrealized Loss (cid:3)(cid:3)
— $
— $
— $
—
20,170
—
(46)
—
5,528
— (cid:3)(cid:3) $
— (cid:3)(cid:3)
(3 ) (cid:3)(cid:3)
Fair Value
Total
Unrealized Loss
—
— $
—
25,698
20,170 $
(46) $
5,528 $
(3 ) (cid:3)(cid:3) $
25,698 $
(1)
(23)
(24)
—
(49)
(49)
As of December 31, 2016, the Company considered the declines in market value of its marketable securities investment portfolio to be
temporary in nature and did not consider any of its investments other-than-temporarily impaired. The Company typically invests in
highly-rated securities, and its investment policy limits the amount of credit exposure to any one issuer. The policy generally requires
investments to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Fair values were
determined for each individual security in the investment portfolio. When evaluating an investment for other-than-temporary
impairment, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the
financial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell, or whether
it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. During the years
ended December 31, 2016, 2015 and 2014, the Company did not recognize any other-than-temporary impairment loss. The Company
has no current requirement or intent to sell the securities in an unrealized loss position. The Company expects to recover up to (or
beyond) the initial cost of investment for securities held.
The Company recognized $0.8 million of realized gains from the sale of available-for-sale investments during the year ended
December 31, 2016. Minimal gross realized gains were recorded during the years ended December 31, 2015 and 2014. The Company
did not record any gross realized losses during the years ended December 31, 2016, 2015 and 2014.
Note 5. Inventories
Inventories at December 31, 2016 and 2015, consisted of the following (in thousands):
Work-in-process ......................................................................... $
Finished goods ...........................................................................
Total inventories ................................................................... $
5,044 $
7,487
12,531 $
3,187
7,625
10,812
December 31,
2016
2015
92
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Note 6. Property and Equipment, net
Property and equipment, net at December 31, 2016 and 2015, consisted of the following (in thousands):
December 31,
2016
2015
Leasehold improvements ........................................................... $
Machinery and equipment ..........................................................
Demonstration equipment ..........................................................
Furniture and fixtures .................................................................
Computer equipment ..................................................................
Computer software .....................................................................
Consigned equipment.................................................................
Construction-in-progress ............................................................
Total property and equipment, gross ....................................
Accumulated depreciation and amortization ..............................
Total property and equipment, net ........................................ $
5,678 $
1,925
167
871
603
2,908
1,058
62
13,272
(10,287)
2,985 $
5,678
1,603
145
794
591
2,935
1,010
219
12,975
(9,426 )
3,549
Depreciation and amortization expense related to property and equipment, net was $1.1 million, $1.1 million and $0.7 million for the
years ended December 31, 2016, 2015 and 2014, respectively. As part of the Company’s 2016 review of property and equipment,
$0.2 million was recorded to impairment of long-lived assets on the consolidated statement of operations for construction-in-progress
related to a deposit associated with a terminated agreement. No such impairment charges were incurred for the years ended
December 31, 2015 and 2014.
Note 7. Goodwill and Intangible Assets, net
Goodwill
During the year ended December 31, 2016, the Company did not dispose of or recognize additional goodwill. On August 31, 2016, the
Company performed its impairment test of goodwill. As described in Note 2 above, the Company applied the enterprise approach by
reviewing the quoted market capitalization of the Company as reported on the Nasdaq Global Market to calculate the fair value. In
addition, the Company considered its future forecasted results, the economic environment and overall market conditions. As a result of
the Company’s assessment that its fair value of the reporting unit exceeded its carrying amount, the Company determined that
goodwill was not impaired.
Intangible Assets, net
The following is a summary of intangible assets, net at December 31, 2016 (in thousands):
Gross
Carrying Amount
December 31, 2016
Accumulated
Amortization
Net
Carrying Amount
Acquisition-related intangible assets:
Reacquired license - INTERCEPT Asia ........................... $
Total intangible assets .................................................. $
2,017 $
2,017 $
(1,279 ) $
(1,279 ) $
738
738
The following is a summary of intangible assets, net at December 31, 2015 (in thousands):
Gross
Carrying Amount
December 31, 2015
Accumulated
Amortization
Net
Carrying Amount
Acquisition-related intangible assets:
Reacquired license - INTERCEPT Asia ........................... $
Total intangible assets .................................................. $
2,017 $
2,017 $
(1,077 ) $
(1,077 ) $
940
940
93
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
During the years ended December 31, 2016, 2015 and 2014, there were no impairment charges recognized related to the Company’s
intangible assets.
At December 31, 2016, the expected annual amortization expense of the intangible assets, net is $0.2 million beginning with the year
ending December 31, 2017, and each subsequent year thereafter through the year ending December 31, 2019, and $0.1 million for the
year ending December 31, 2020.
Note 8. Marketable Equity Investments
In connection with the agreements to license the immunotherapy technologies to Aduro in 2009, the Company received preferred
shares of Aduro, a privately held company at the time the Company received such shares. Pursuant to these license agreements, the
Company was eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. For the years ended
December 31, 2016, 2015 and 2014, the Company has not received any royalty payments from Aduro pursuant to this agreement. The
Company historically accounted for the investment under the cost method of accounting with a net carrying value of zero. In April
2015, Aduro’s common stock began trading on the NASDAQ Global Select Market, under the symbol “ADRO”. At the time of
Aduro’s initial public offering (“IPO”), the Company’s preferred shares in Aduro converted to 396,700 shares of common stock, and
the fair value of the Company’s investment became readily determinable and, as a result became a marketable equity security.
Therefore, the Company no longer accounts for the investment in Aduro under the cost basis of accounting. The Company now
reflects the investment in Aduro as an available-for-sale security included in investment in marketable equity securities on the
Company’s consolidated balance sheet (Note 4) and will adjust the carrying value of this investment to fair value each quarterly
reporting period, with changes in fair value recorded within other comprehensive income (loss), net of tax. During the year ended
December 31, 2016, the Company sold 50,000 shares of Aduro common stock and recognized a gain of $0.8 million in “Other
income, net” on the Company’s consolidated statements of operations. As of December 31, 2016, the Company had 346,700 shares of
Aduro common stock.
Note 9. Accrued Liabilities
Accrued liabilities at December 31, 2016 and 2015, consisted of the following (in thousands):
December 31,
2016
2015
Accrued compensation and related costs ................................... $
Accrued professional services ....................................................
Accrued customer costs .............................................................
Accrued insurance premiums .....................................................
Other accrued expenses ..............................................................
Total accrued liabilities ........................................................ $
7,098 $
2,511
534
476
599
11,218 $
5,198
2,337
987
438
893
9,853
Note 10. Debt
Debt at December 31, 2016, consisted of the following (in thousands):
Loan and Security Agreement .................................................. $
Less: debt - current ...................................................................
Debt - non-current .................................................................... $
19,499 $
(7,013)
12,486 $
(124 ) $
79
(45 ) $
19,375
(6,934)
12,441
December 31, 2016
Unamortized
Discount
Net Carrying
Value
Principal
94
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Debt at December 31, 2015, consisted of the following (in thousands):
Loan and Security Agreement .................................................. $
Less: debt - current ...................................................................
Debt - non-current .................................................................... $
20,000 $
(3,050)
16,950 $
(196 ) $
94
(102 ) $
December 31, 2015
Unamortized
Discount
Principal
Total
19,804
(2,956)
16,848
Principal and interest payments on debt at December 31, 2016, are expected to be as follows:
Year ended December 31,
Principal
Interest
Total
2017 .....................................................................................
2018 .....................................................................................
2019 .....................................................................................
Total ............................................................................... $
7,013
8,178
4,308
19,499 $
1,160
613
1,488
3,261 $
8,173
8,791
5,796
22,760
Loan and Security Agreement
On June 30, 2014, the Company entered into a five year loan and security agreement with Oxford Finance LLC (the “Term Loan
Agreement”) to borrow up to $30.0 million in term loans in three equal tranches (the “Term Loans”). On June 30, 2014, the Company
received $10.0 million from the first tranche (“Term Loan A”). The second tranche of $10.0 million (“Term Loan B”) was drawn on
June 15, 2015. On September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in which the third tranche of
$10.0 million (“Term Loan C”) could have been drawn and (ii) the interest-only period for all advances under the Term Loan
Agreement. As a result, the accounting treatment for the Term Loan continued under the interest method, with a new effective interest
rate based on revised cash flows calculated on a prospective basis upon the execution of the amendment to the Term Loan Agreement.
As amended, the availability of Term Loan C was subject to the Company achieving consolidated trailing six months’ revenue at a
specified threshold (the “Revenue Event”) no later than June 30, 2016. The Company did not achieve the Revenue Event by June 30,
2016, and therefore Term Loan C was not available to be drawn. Term Loan A bears an interest rate of 6.95%. Term Loan B bears an
interest rate of 7.01%. Term Loans A and B mature on June 1, 2019. The Company was required to make interest only payments
through June 2016, followed by thirty-six months of equal principal and interest payments thereafter. On July 28, 2016, the Term
Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As
amended, the Company is required to make interest only payments from August 2016 through January 2017, followed by twenty-nine
months of equal principal and interest payments thereafter. The Company determined that the amendment to the Term Loan
Agreement resulted in a modification. As a result, the accounting treatment for the Term Loan will continue under the interest method,
with a new effective interest rate based on revised cash flows calculated on a prospective basis upon the execution of the amendment
to the Term Loan Agreement. The Company is also required to make a final payment equal to 7% of the principal amounts of the
Term Loans drawn payable on the earlier to occur of maturity or prepayment. The costs associated with the final payment are
recognized as interest expense over the life of the Term Loans. The Company may prepay at any time the Term Loans subject to
declining prepayment fees over the term of the Term Loan Agreement. The Company pledged all current and future assets, excluding
its intellectual property and 35% of the Company’s investment in its subsidiary, Cerus Europe B.V., as security for borrowings under
the Term Loan Agreement. The Term Loan Agreement contains certain nonfinancial covenants, with which the Company was in
compliance at December 31, 2016.
Note 11. Commitments and Contingencies
Operating Leases
The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment under
non-cancelable operating leases with initial terms in excess of one year that require the Company to pay operating costs, property
taxes, insurance and maintenance. The operating leases expire at various dates through 2021, with certain of the leases providing for
renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to terminate the lease
early. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its
consolidated balance sheets.
95
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Future minimum non-cancelable lease payments under operating leases as of December 31, 2016, are as follows (in thousands):
Year ended December 31,
2017 ........................................................................................ $
2018 ........................................................................................
2019 ........................................................................................
2020 ........................................................................................
2021 ........................................................................................
Total minimum non-cancellable lease payments ......................... $
1,233
868
739
30
2
2,872
Rent expense for office facilities was $0.8 million, $0.8 million and $0.7 million for the years ended December 31, 2016, 2015 and
2014, respectively.
Financed Leasehold Improvements
In 2010, the Company financed $1.1 million of leasehold improvements. The Company pays for the financed leasehold improvements
as a component of rent and is required to reimburse its landlord over the remaining life of the respective leases. At December 31,
2016, the Company had an outstanding liability of $0.4 million related to these leasehold improvements, of which $0.1 million was
reflected in “Accrued liabilities” and $0.3 million was reflected in “Other non-current liabilities” on the Company’s consolidated
balance sheets.
Purchase Commitments
The Company is party to agreements with certain providers for certain components of INTERCEPT Blood System which the
Company purchases from third party manufacturers. Certain of these agreements require minimum purchase commitments from the
Company. The Company has paid $6.9 million, $7.7 million and $6.8 million for goods under agreements which are subject to
minimum purchase commitments during the years ended December 31, 2016, 2015 and 2014, respectively. As of December 31, 2016,
the Company has future minimum purchase commitments under these agreements of approximately $6.5 million, $0.6 million, $0.3
million, $0.4 million and $1.7 million for the years ending December 31, 2017, 2018, 2019, 2020 and 2021 respectively.
In June 2014, the Company terminated its distribution agreement with one of its distributors in certain countries and entered into an
agreement to provide for specific post-termination obligations (the “Transition Agreement”). The Transition Agreement expired
September 30, 2014. The Company is required to pay this former distributor a fee of €10 per disposable kit for platelet systems sold
by the Company to any customer in certain countries commencing with the termination of the agreement through April 1, 2018,
subject to a maximum payment of €3 million. During the year ended December 31, 2016, the Company paid approximately $0.5
million (€0.5 million) associated with this fee. To date, the Company has paid €0.9 million cumulatively of the €3 million maximum
payment. As of December 31, 2016, the Company had accrued $0.1 million (€0.1 million) associated with this fee. As this former
distributor remains as a customer in other countries, in accordance with ASC Topic 605-50 “Customer Payments and Incentives” any
fees paid to the former distributor related to INTERCEPT disposable kits are offset against the revenue associated with the sale of
INTERCEPT disposable kits in those territories.
Note 12. Stockholders’ Equity
Sales Agreement
On May 5, 2016, the Company entered into Amendment No. 2 to the Controlled Equity OfferingSM Sales Agreement, dated August
31, 2012, as previously amended on March 21, 2014, (together, the “Amended Cantor Agreement”) with Cantor Fitzgerald & Co.
(“Cantor”) that provides for the issuance and sale of shares of the Company’s common stock over the term of the Amended Cantor
Agreement having an aggregate offering price of up to $132.2 million through Cantor. As a result of Amendment No. 2, at May 5,
2016, the Company had $70 million of common stock available to be sold under the Amended Cantor Agreement. Under the
Amended Cantor Agreement, Cantor also acts as the Company’s sales agent and receives compensation based on an aggregate of 2%
of the gross proceeds on the sale price per share of its common stock. The issuance and sale of these shares by the Company pursuant
to the Amended Cantor Agreement are deemed an “at-the-market” offering and are registered under the Securities Act of 1933, as
amended. During the year ended December 31, 2016 and 2015, 3.5 million and zero shares, respectively, of the Company’s common
96
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
stock were sold under the Amended Cantor Agreement for net proceeds of $22.0 million and zero, respectively. At December 31,
2016, the Company had $62.3 million of common stock available to be sold under the Amended Cantor Agreement.
Stockholder Rights Plan
In October 2009, the Company’s Board of Directors adopted an amendment to its 1999 stockholder rights plan, commonly referred to
as a “poison pill,” to reduce the exercise price, extend the expiration date and revise certain definitions under the plan. The stockholder
rights plan is intended to deter hostile or coercive attempts to acquire the Company. The stockholder rights plan enables stockholders
to acquire shares of the Company’s common stock, or the common stock of an acquirer, at a substantial discount to the public market
price should any person or group acquire more than 15% of the Company’s common stock without the approval of the Board of
Directors under certain circumstances. The Company has designated 250,000 shares of Series C Junior Participating preferred stock
for issuance in connection with the stockholder rights plan. As of December 31, 2016, no Series C Junior Participating preferred stock
has been issued.
Common Stock and Associated Warrant Liability
In November 2010, the Company issued warrants (“2010 Warrants”) to purchase 3.7 million shares of common stock, exercisable at
an exercise price of $3.20 per share. The 2010 Warrants became exercisable on May 15, 2011, and were exercisable for a period of
five years from the issue date. In 2015, all outstanding 2010 Warrants were exercised in full. At December 31, 2016, the Company had
no outstanding warrants remaining.
Note 13. Stock-Based Compensation
Employee Stock Plans
Employee Stock Purchase Plan
The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock
purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of
Directors may authorize participation by eligible employees, including officers, in periodic offerings. Under the Purchase Plan eligible
employee participants may purchase shares of common stock of the Company at a purchase price equal to 85% of the lower of the fair
market value per share on the start date of the offering period or the fair market value per share on the purchase date. The Purchase
Plan consists of a fixed offering period of 12 months with two purchase periods within each offering period. The Purchase Plan was
authorized to issue an aggregate of 1,320,500 shares. On June 10, 2015, the Company’s stockholders approved an amendment and
restatement of the Purchase Plan that increased the aggregate number of shares of common stock authorized for issuance under the
Purchase Plan by 1,500,000 shares. At December 31, 2016, the Company had 1,438,211 shares available for future issuance.
2008 Equity Incentive Plan and Inducement Plan
The Company also maintains an equity compensation plan to provide long-term incentives for employees, contractors, and members
of its Board of Directors. The Company currently grants equity awards from one plan, the 2008 Equity Incentive Plan (the “2008
Plan”). The 2008 Plan allows for the issuance of non-statutory and incentive stock options, restricted stock, restricted stock units
(“RSUs”), stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other
property. On June 6, 2012 and June 12, 2013, the stockholders approved amendments to the 2008 Plan (collectively the “Amended
2008 Plan”) such that the Amended 2008 Plan has reserved for issuance an amount not to exceed 19.5 million shares. On June 10,
2015, the Company’s stockholders approved an amendment and restatement of the 2008 Plan that increased the aggregate number of
shares of common stock authorized for issuance under the 2008 Plan by 5,000,000 shares. Awards under the Amended 2008 Plan
generally have a maximum term of 10 years from the date of the award. The Amended 2008 Plan generally requires options to be
granted at 100% of the fair market value of the Company’s common stock subject to the option on the date of grant. Options granted
by the Company to employees generally vest over four years. RSUs are measured based on the fair market value of the underlying
stock on the date of grant and will generally vest over three years. Performance-based stock or cash awards granted under the
Amended 2008 Plan are limited to either 500,000 shares of common stock or $1.0 million per recipient per calendar year. The
attainment of any performance-based awards granted shall be conclusively determined by a committee designated by the Company’s
Board of Directors. At December 31, 2016, no performance-based stock options were outstanding. On August 31, 2016, the
Company’s Board of Directors adopted the Cerus Corporation Inducement Plan (the “Inducement Plan”), and reserved 1,250,000
shares of its common stock under the Inducement Plan to be used exclusively for the issuance of non-statutory stock options and
restricted stock units to individuals who were not previously employees or directors of the Company, or who had experienced a bona
97
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
fide period of non-employment, as an inducement material to the individual’s entry into employment with the Company within the
meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules. The Inducement Plan was approved by the Company’s Board of Directors
without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Inducement Plan are substantially
similar to the Amended 2008 Plan.
At December 31, 2016, the Company had an aggregate of approximately 21.6 million shares of its common stock subject to
outstanding options or remaining available for future issuance under the Amended 2008 Plan, of which approximately 15.8 million
shares and 0.7 million shares were subject to outstanding options and outstanding RSUs, respectively, and approximately 5.1 million
shares were available for future issuance under the Amended 2008 Plan. The Company’s policy is to issue new shares of common
stock upon the exercise of options.
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except weighted average
exercise price):
Number of Options
Outstanding
Weighted Average
Exercise Price per
Share
Balances at December 31, 2015 ...............................................................
Granted ...............................................................................................
Forfeited .............................................................................................
Expired ...............................................................................................
Exercised ............................................................................................
Balances at December 31, 2016 ...............................................................
14,119 $
2,722
(287 )
(128 )
(639 )
15,787
4.21
5.39
4.93
9.18
3.45
4.39
Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):
Number of
Shares
Outstanding
Weighted
Average
Grant Date
Fair Value
per Share
Balances at December 31, 2015 ..................................................................
Granted ..................................................................................................
Forfeited ................................................................................................
Vested....................................................................................................
Balances at December 31, 2016 ..................................................................
— $
762
(23 )
—
739
—
5.26
5.06
—
5.26
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options
exercisable at December 31, 2016, was as follows (in thousands except weighted average exercise price and contractual term):
Number of Shares
Weighted Average
Exercise Price
Weighted Average
Remaining
Contractual Term
(Years)
Aggregate Intrinsic
Value
Balances at December 31, 2016 ...................................
Stock options outstanding .......................................
Stock options vested and expected to vest ..............
Stock options exercisable ........................................
15,787 $
15,541
10,600
4.39
4.38
4.03
6.3 $
6.2
5.3
8,696
8,695
8,557
The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the stock option and the
Company’s closing stock price on the last trading day of each respective fiscal period.
The total intrinsic value of options exercised for the years ended December 31, 2016, 2015 and 2014, was $1.9 million, $1.2 million
and $3.8 million, respectively.
98
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Stock-based Compensation Expense
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended
December 31, 2016, 2015 and 2014, was as follows (in thousands):
Stock-based compensation expense by caption:
Research and development .................................................. $
Selling, general and administrative .....................................
Total stock-based compensation expense ...................... $
1,091 $
6,974
8,065 $
1,260 $
5,470
6,730 $
998
4,155
5,153
Year Ended December 31,
2015
2014
2016
Stock-based compensation expense in the above table does not reflect any income taxes as the Company has experienced a history of
net losses since its inception and has a full valuation allowance on its deferred tax assets. In addition, there was neither income tax
benefits realized related to stock-based compensation expense nor any stock-based compensation costs capitalized as part of an asset
during the years ended December 31, 2016, 2015 and 2014. The Company has also not recorded any stock-based compensation
associated with performance-based stock options during the years ended December 31, 2016, 2015 and 2014.
As of December 31, 2016, the Company expects to recognize the remaining unamortized stock-based compensation expense of $11.2
million and $2.6 million, respectively, related to non-vested stock options and RSUs, net of estimated forfeitures, over an estimated
remaining weighted average period of 2.4 years and 2.2 years, respectively.
Valuation Assumptions for Stock-based Compensation
The Company currently uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and
employee stock purchase plan shares. The Black-Scholes option-pricing model is affected by the Company’s stock price, as well as
assumptions regarding a number of complex and subjective variables, which include the expected term of the grants, actual and
projected employee stock option exercise behaviors, including forfeitures, the Company’s expected stock price volatility, the risk-free
interest rate and expected dividends. The Company recognizes the grant-date fair value of the stock award as stock-based
compensation expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for
estimated forfeitures.
The expected life of the stock options is based on observed historical exercise patterns. Groups of employees having similar historical
exercise behavior are considered separately for valuation purposes. The Company estimates stock option forfeitures based on
historical data for employee groups. The total number of stock options expected to vest is adjusted by actual and estimated forfeitures.
The expected volatility is estimated by using historical volatility of the Company’s common stock. The risk-free interest rate is based
on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term commensurate with the expected term of the option.
The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of
zero.
99
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2016, 2015
and 2014, was as follows:
Year Ended December 31,
2015
2014
2016
Stock Options:
Expected term (in years) ...........................................................
Estimated volatility ...................................................................
Risk-free interest rate ................................................................
Expected dividend yield ...........................................................
Employee Stock Purchase Plan Rights:
Expected term (in years) ...........................................................
Estimated volatility ...................................................................
Risk-free interest rate ................................................................
Expected dividend yield ...........................................................
5.85
49%
1.41%
0%
0.76
47%
0.55%
0%
5.66
56%
1.55%
0%
0.75
53%
0.28%
0%
5.71
61%
1.73%
0%
0.76
52%
0.10%
0%
The weighted average grant-date fair value of stock options granted during the years ended December 31, 2016, 2015 and 2014, was
$2.55 per share, $2.35 per share and $3.28 per share, respectively. The weighted average grant-date fair value of employee stock
purchase rights during the years ended December 31, 2016, 2015 and 2014, was $1.87 per share, $1.54 per share and $1.42 per share,
respectively.
Note 14. Retirement Plan
The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k)
of the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S.
employees may make pre-tax dollar contributions of up to 60% of their eligible pay up to a maximum cap established by the IRS. The
Company may contribute a discretionary percentage of qualified individual employee’s salaries, as defined, to the 401(k) Plan. The
Company has not contributed to the 401(k) Plan during the years ended December 31, 2016, 2015 and 2014.
Note 15. Development and License Agreements
Agreements with Fresenius
Fresenius manufactures and supplies the platelet and plasma systems to the Company under a supply agreement. Under the previous
agreements with Fresenius, the Company was required to pay royalties to Fenwal Inc. (“Fenwal”), a subsidiary of Fresenius, on
INTERCEPT Blood System product sales at royalty rates that varied by product. During the years ended December 31, 2016, 2015
and 2014, the Company made royalty payments to Fresenius of zero, $1.9 million and $2.5 million, respectively. In addition,
Fresenius was obligated to sell, and the Company was obligated to purchase, up to a certain specified annual volume of finished
disposable kits for the platelet and plasma systems from Fresenius for both clinical and commercial use. The pricing was fixed for
finished kits with successive decreasing pricing tiers at various annual production volumes. Fresenius was also obligated to purchase
and maintain specified inventory levels of the Company’s proprietary inactivation compounds and adsorption media from the
Company at fixed prices.
In October 2015, the Company entered into an Amended and Restated Manufacturing and Supply Agreement (the “2015 Agreement”)
with Fresenius, which amended and restated its previous agreements. Under the 2015 Agreement, Fresenius continues to be obligated
to sell and the Company is obligated to purchase finished disposable kits for the Company’s platelet and plasma systems and the
Company’s red blood cell system product candidate (the “RBC Sets”). The 2015 Agreement permits the Company to purchase platelet
and plasma systems and RBC Sets from third parties to the extent necessary to maintain supply qualifications with such third parties
or where local or regional manufacturing is needed to obtain product registrations or sales. Pricing terms per unit are initially fixed and
decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term. Under the 2015
Agreement, the Company is no longer required to make royalty payments to Fenwal for the sale of products after June 30, 2015.
Under the 2015 Agreement, the Company maintains the amounts due from the components sold to Fresenius as a current asset on its
accompanying consolidated balance sheets until such time as the Company purchases finished disposable kits using those components.
100
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
The 2015 Agreement also requires the Company to make certain payments totaling €8.6 million (“Manufacturing and Development
Payments”) to Fresenius in 2016 and on December 31 of the earlier of (a) the year of achievement of certain production volumes or
(b) 2022. Because these payments represent unconditional payment obligations, the Company recognized its liability for these
payments at their net present value at discount rate of 9.72% based on the Company’s effective borrowing rate. The Manufacturing
and Development Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As
of December 31, 2016, the Company had paid $3.4 million (€3.1 million) and accrued $4.8 million (€4.5 million) related to the
Manufacturing and Development Payments, which was included in “Manufacturing and development obligations - non-current” on the
Company’s Consolidated Balance Sheets.
As of December 31, 2015, the Company had accrued $7.8 million (€7.2 million) related to the Manufacturing and Development
Payments, of which $3.3 million (€3.0 million) was included in “Manufacturing and development obligations - current”, and $4.5
million (€4.2 million) was included in “Manufacturing and development obligations - non-current” on the Company’s Consolidated
Balance Sheets.
The Manufacturing and Development Payments will be made to support certain projects Fresenius will perform on behalf of the
Company related to R&D activities and manufacturing efficiency activities. The Company allocated $4.8 million to R&D activities
and $2.4 million to manufacturing efficiency activities based on their market value in October 2015. The prepaid asset related to
amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company is expensed over the period
which such activities occur. The manufacturing efficiency asset is expensed on a straight line basis over the life of the 2015
Agreement. As of December 31, 2016, the prepaid asset related to amounts paid up front for the R&D activities to be conducted by
Fresenius on behalf of the Company was included in “Other current assets” and “Other assets” on the Company’s Consolidated
Balance Sheets at $0.9 million and $2.0 million, respectively. As of December 31, 2015, the prepaid asset related to amounts paid up
front for the R&D activities to be conducted by Fresenius on behalf of the Company was included in “Other current assets” on the
Company’s Consolidated Balance Sheets at $4.1 million. As of December 31, 2016 and December 31, 2015, the manufacturing
efficiency asset was included in “Other assets” on the Company’s Consolidated Balance Sheets at $2.1 million and $2.4 million,
respectively.
The initial term of the 2015 Agreement extends through July 1, 2025 (the “Initial Term”) and is automatically renewed thereafter for
additional two year terms (each, a “Renewal Term”), subject to termination by either party upon (i) two years written notice prior to
the expiration of the Initial Term or (ii) one year written notice prior to the expiration of any Renewal Term. Under the 2015
Agreement, the Company has the right, but not the obligation, to purchase certain assets and assume certain liabilities from Fresenius.
The Company made payments to Fresenius of $16.1 million, $14.9 million and $19.1 million relating to the manufacturing of the
Company products during the years ended December 31, 2016, 2015 and 2014, respectively. At December 31, 2016 and
December 31, 2015, the Company owed Fresenius $3.0 million and $2.5 million, respectively, for INTERCEPT disposable kits
manufactured. At December 31, 2016 and December 31, 2015, amounts due from Fresenius were $0.3 million and $0.2 million,
respectively.
Agreement with BARDA
In June 2016, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority
(“BARDA”) to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and
red blood cells.
The five-year agreement with BARDA includes a base period (the “Base Period”) and options (each an “Option Period”) with
committed funding of up to $41.6 million for clinical development of the INTERCEPT Blood System for red blood cells (the “red
blood cell system”) and subsequent Option Periods that, if exercised by BARDA and completed, would bring the total funding
opportunity to $185.0 million over the five-year contract period. If exercised by BARDA, subsequent options would fund activities
related to broader implementation of the platelet and plasma system or the red blood cell system in areas of Zika virus risk, clinical
and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development,
manufacturing and scale-up activities for the red blood cell system. The Company would be responsible for co-investment of up to
$15.0 million, if certain options were to be exercised. BARDA will make periodic assessments of the Company’s progress and the
continuation of the agreement is based on the Company’s success in completing the required tasks under the Base Period and each
Option Period (if and to the extent any Option Periods are exercised by BARDA). BARDA has rights under certain contract clauses to
terminate the agreement, including the ability to terminate the agreement for convenience at any time.
101
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Under the contract, the Company is reimbursed and recognizes revenue as allowable direct contract costs are incurred plus allowable
indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and
administrative expenses. As of December 31, 2016 and 2015, $1.0 million and zero, respectively, was included in accounts receivable
on the Company’s Consolidated Balance Sheets.
Note 16. Income Taxes
U.S and foreign components of consolidated loss before income taxes for the years ended December 31, 2016, 2015 and 2014, was as
follows (in thousands):
Loss before income taxes:
U.S. ..................................................................................... $
Foreign ................................................................................
Loss before income taxes......................................................... $
(63,246) $
515
(62,731) $
(59,897 ) $
358
(59,539 ) $
(38,928)
368
(38,560)
2016
2015
2014
The provision for income taxes for the years ended December 31, 2016, 2015 and 2014, was as follows (in thousands):
2016
2015
2014
Provision for income taxes:
Current:
Foreign ................................................................................ $
Federal .................................................................................
State .....................................................................................
Total current ..................................................................
Deferred:
Foreign ................................................................................
Federal .................................................................................
State .....................................................................................
Total deferred.................................................................
Provision (benefit) for income taxes ........................................ $
147 $
—
—
147
—
28
—
28
175 $
147 $
—
—
147
—
(3,750 )
(68 )
(3,818 )
(3,671 ) $
168
—
1
169
—
22
4
26
195
The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to
loss before taxes for the years ended December 31, 2016, 2015 and 2014, was as follows (in thousands):
Federal statutory tax ................................................................. $
Warrants ...................................................................................
Expiration of federal loss carryovers ........................................
Change in valuation allowance .................................................
Change in state apportionment .................................................
Revision to prior year items ......................................................
Other .........................................................................................
Provision (benefit) for income taxes ......................................... $
2016
(21,329) $
—
—
13,589
—
7,551
364
175 $
2015
(20,243 ) $
(3,565 )
3,337
11,754
4,085
—
961
(3,671 ) $
2014
(13,110)
(3,367)
—
16,576
—
—
96
195
On December 31, 2015, the California Supreme Court issued a decision disallowing the use of an income apportionment method
pursuant to the Multistate Tax Compact. On October 10, 2016, the U.S Supreme Court decided not to hear an appeal of this decision.
Previously the Company had relied on lower court decisions allowing the use of this apportionment method to file its 2013 and 2014
tax returns and to determine its deferred tax balances. Based on the California Supreme Court decision, the Company adjusted the
apportionment for its deferred tax balances and the respective valuation allowance as of December 31, 2015.
102
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
During 2016 the Company reviewed its cumulative research tax credits and tax losses. As part of this review, revisions were made to
the amounts as originally estimated which are reflected in the deferred tax balances and the respective valuation allowance as of
December 31, 2016.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for
financial reporting purposes and the amounts used for income tax purposes at the enacted rates. The significant components of the
Company’s deferred tax assets and liabilities at December 31, 2016 and 2015, were as follows (in thousands):
December 31,
2016
2015
Deferred tax assets:
Net operating loss carryforwards .......................................... $
Research and development credit carryforwards ..................
Capitalized research and development .................................
Deferred compensation .........................................................
Other .....................................................................................
Total deferred tax assets .......................................................
Valuation allowance...................................................................
Net deferred tax assets .......................................................... $
176,490 $
31,777
22,575
8,242
3,184
242,268
(238,443)
3,825 $
165,813
35,131
17,916
5,908
3,911
228,679
(224,854 )
3,825
Deferred tax liabilities:
Unrealized gain on investments ...................................... $
Amortization of goodwill ................................................
Total deferred tax liabilities ....................................... $
3,825 $
150
3,975 $
3,825
122
3,947
The valuation allowance increased by $13.6 million for the year ended December 31, 2016, compared to the increase of $11.8 million
and $14.1 million for the years ended December 31, 2015 and 2014, respectively. The Company believes that, based on a number of
factors, the available objective evidence creates sufficient uncertainty regarding the realizability of the deferred tax assets such that a
valuation allowance has been recorded. These factors include the Company’s history of net losses since its inception, the need for
regulatory approval of the Company’s products prior to commercialization, expected near-term future losses and the absence of
taxable income in prior carryback years. The Company expects to maintain a valuation allowance until circumstances change.
Undistributed earnings of the Company’s foreign subsidiary, Cerus Europe B.V., amounted to approximately $5.2 million at
December 31, 2016. The earnings are considered to be permanently reinvested and accordingly, no deferred U.S. income taxes have
been provided thereon. Upon distribution of those earnings in the form of dividends or otherwise, the Company would be subject to
U.S. income taxes. The unrecognized deferred tax liability for unrepatriated earnings at December 31, 2016, was approximately $1.9
million. In the event all foreign undistributed earnings were remitted to the U.S., the Company believes any incremental tax liability
would be offset by the Company’s domestic net operating losses and credits.
For the year ended December 31, 2016, the Company reported pretax net losses of $62.7 million on its consolidated statement of
operations and calculated taxable losses for both federal and state taxes. The difference between reported net loss and taxable loss are
due to differences between book accounting and the respective tax laws.
At December 31, 2016, the Company had federal and state net operating loss carryforwards of approximately $503 million and $94
million, respectively. The net operating loss carryforwards for federal and state expire at various dates beginning in 2017 through
2036. The Company’s net operating losses do not include $2.8 million related to windfall tax deductions associated with stock based
compensation. The stock based compensation windfall deductions, if utilized, would serve to reduce any income taxes payable with a
corresponding credit to additional paid in capital.
At December 31, 2016, the Company had federal research and development credit carryforwards of approximately $23.9 million that
expire in various years between 2018 and 2036. The California research and development credits are approximately $11.9 million as
of December 31, 2016, and have an indefinite carryover period.
103
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
The utilization of net operating loss carryforwards, as well as research and development credit carryforwards, is limited by current tax
regulations. These net operating loss carryforwards, as well as research and development credit carryforwards, will be utilized in
future periods if sufficient income is generated. The Company’s ability to utilize certain loss carryforwards and certain research credit
carryforwards are subject to limitations pursuant to the ownership change rules in accordance with Section 382 of the Internal
Revenue Code of 1986 and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions.
The Company’s unrecognized tax benefits relate to federal and California research tax credits. These tax credits have not been
utilized on any tax return and currently have no impact on the Company’s tax expense due to the Company’s operating losses and the
related valuation allowances.
The following is a tabular reconciliation of the total amounts of unrecognized tax benefits (in thousands):
Unrecognized tax benefits at beginning of period .......................................................... $
Increases related to prior year tax positions ..............................................................
Increases related to current year tax positions ...........................................................
Unrecognized tax benefits at beginning of period .......................................................... $
—
10,691
145
10,836
December 31,
2016
The Company will recognize accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the
Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made
payments for interest and penalties.
The Company’s federal tax years 1998 through 2015 and California tax years through 2015 remain subject to examination by the
taxing jurisdictions due to unutilized net operating losses and research credits. The Netherlands tax returns of our Cerus Europe B.V.
subsidiary for the years 2013 through 2015 are still subject to examination. There was no income tax audit activity in 2015 nor has the
Company been notified by any tax agency of any planned audits.
Note 17. Segment, Customer and Geographic Information
The Company continues to operate in only one segment, blood safety. The Company’s chief executive officer is the chief operating
decision maker who evaluates performance based on the net revenues and operating loss of the blood safety segment. The Company
considers the sale of all of its INTERCEPT Blood System products to be similar in nature and function, and any revenue earned from
services is minimal.
The Company’s operations outside of the U.S. include a wholly-owned subsidiary headquartered in Europe. The Company’s
operations in the U.S. are responsible for the research and development and global and domestic commercialization of the
INTERCEPT Blood System, while operations in Europe are responsible for the commercialization efforts of the platelet and plasma
systems in Europe, the Commonwealth of Independent States and the Middle East. Product revenues are attributed to each region
based on the location of the customer, and in the case of non-product revenues, on the location of the collaboration partner.
The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, all
of which operate in a country outside of the U.S., during the years ended December 31, 2016, 2015 and 2014 (in percentages):
Advanced Technology ......................................................................................
Etablissement Francais du Sang ........................................................................
*
Represents an amount less than 10% of product revenue.
2016
12%
*
Year Ended December 31,
2015
*
23%
2014
*
25%
104
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Revenues by geographical location was based on the location of the customer during the years ended December 31, 2016, 2015 and
2014, and was as follows (in thousands):
Product revenue:
Belgium ............................................................................... $
United States .......................................................................
Kuwait .................................................................................
France ..................................................................................
Spain and Portugal ..............................................................
Switzerland ..........................................................................
CIS ......................................................................................
Other countries ....................................................................
Total product revenue ....................................................
Government contracts revenue:
United States .......................................................................
Total government contracts revenue ..............................
Total revenue ............................................................ $
Year Ended December 31,
2015
2014
2016
6,392 $
4,480
4,415
3,485
3,360
3,324
2,859
8,868
37,183
2,092
2,092
39,275 $
5,728 $
563
1,959
7,732
4,070
2,938
3,361
7,872
34,223
—
—
34,223 $
4,456
350
2,557
9,184
2,776
3,784
6,636
6,673
36,416
—
—
36,416
Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31,
2016 and 2015, were as follows (in thousands):
U.S. and territories ..................................................................... $
Europe & other ...........................................................................
Total long-lived assets .......................................................... $
3,529 $
194
3,723 $
4,260
229
4,489
December 31,
2016
2015
Note 18. Quarterly Financial Information (Unaudited)
The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2016 and 2015 (in
thousands except per share amounts):
Product revenue ................................................................................ $
Gross profit on product revenue ........................................................
Government contracts revenue ..........................................................
Net loss .............................................................................................
Net loss per share:
Three Months Ended
March 31,
2016
June 30,
2016
September 30,
2016
December 31,
2016
7,632 $
3,369
—
(16,863)
9,251 $
4,275
—
(18,166 )
10,175 $
4,724
261
(14,376)
10,125
4,520
1,831
(13,501)
Basic ............................................................................................
Diluted .........................................................................................
(0.17)
(0.17)
(0.18 )
(0.18 )
(0.14)
(0.14)
(0.13)
(0.13)
105
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—(Continued)
CERUS CORPORATION
December 31, 2016
Product revenue ................................................................................ $
Gross profit on product revenue ........................................................
Government contracts revenue ..........................................................
Net loss .............................................................................................
Net loss per share:
Three Months Ended
March 31,
2015
June 30,
2015
September 30,
2015
December 31,
2015
7,692 $
2,978
—
(9,460)
8,830 $
1,802
—
(15,972 )
8,045 $
2,485
—
(15,680)
9,656
3,494
—
(14,756)
Basic ............................................................................................
Diluted .........................................................................................
(0.10)
(0.17)
(0.17 )
(0.17 )
(0.16)
(0.17)
(0.15)
(0.15)
106
Pursuant to the requirement of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report
to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Concord, State of California, on the 8th day of
March, 2017.
SIGNATURES
CERUS CORPORATION
By:
/s/ WILLIAM M. GREENMAN
William M. Greenman
President and Chief Executive Officer
Each person whose signature appears below constitutes and appoints William M. Greenman and Kevin D. Green, his true and lawful
attorney-in-fact and agent, each acting alone, with full power of substitution and resubstitution, for him and in his name, place and
stead, in any and all capacities, to sign any or all amendments to the Annual Report on Form 10-K and to file the same, with all
exhibits thereto, and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said
attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done
in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all
that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons in the
capacities and on the dates indicated.
Signature
Title
Date
/s WILLIAM M. GREENMAN
William M. Greenman
/s/ KEVIN D. GREEN
Kevin D. Green
/s/ DANIEL. N. SWISHER, JR.
Daniel N. Swisher, Jr.
/s/ TIMOTHY B. ANDERSON
Timothy B. Anderson
/s/ LAURENCE M. CORASH, M.D.
Laurence M. Corash, M.D.
/s/ BRUCE C. COZADD
Bruce C. Cozadd
/s/ GAIL SCHULZE
Gail Schulze
/s/ FRANK WITNEY
Frank Witney, PHD.
President, Chief Executive
Officer and Director
(Principal Executive Officer)
Vice President, Finance and
Chief Financial Officer
(Principal Financial Officer)
March 8, 2017
March 8, 2017
Chairman of the Board of Directors
March 8, 2017
Director
Director
Director
Director
Director
March 8, 2017
March 8, 2017
March 8, 2017
March 8, 2017
March 8, 2017
107
INDEX TO EXHIBITS
3.2(22)
3.1(22)
3.3(22)
Description of Exhibit
(cid:3)
Exhibit Number
(cid:3)
Amended and Restated Certificate of Incorporation of Cerus Corporation.
(cid:3)
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.
(cid:3)
Certificate of Designation of Series C Junior Participating Preferred Stock of Cerus Corporation.
(cid:3)
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.
(cid:3)
Amended and Restated Bylaws of Cerus Corporation.
(cid:3)
Specimen Stock Certificate.
(cid:3)
Rights Agreement, dated as of November 3, 1999, as amended as of August 6, 2001, between Cerus Corporation and
Wells Fargo Bank, N.A. (formerly known as Norwest Bank Minnesota, N.A.).
3.4(28)
4.2(14)
3.5(8)
4.1(1)
4.3(15)
(cid:3)
10.1(7)†
(cid:3)
Amendment to Rights Agreement, dated as of October 28, 2009, between Cerus Corporation and Wells Fargo Bank,
N.A. (which includes the form of Rights Certificate as Exhibit B thereto).
(cid:3)
Supply and/or Manufacturing Agreements
(cid:3)
Supply Agreement, dated December 19, 2007, by and between Cerus Corporation and Brotech Corporation d/b/a
Purolite Company.
10.2(29)†
Amended and Restated Supply Agreement, dated April 21, 2014, by and between Cerus Corporation and Purolite
Corporation.
10.3(7)†
10.4(23)†
(cid:3)
Supply and Manufacturing Agreement, dated March 1, 2008, by and between Cerus Corporation and Porex
Corporation.
(cid:3)
First Amendment to Supply and Manufacturing Agreement, dated November 28, 2012, by and between Cerus
Corporation and Porex Corporation.
10.5(30)†
Amendment #2 to Supply and Manufacturing Agreement, dated December 23, 2014, by and between Cerus
Corporation and Porex Corporation.
10.6
10.7
10.8(34)†
10.9(10)†
10.10(35)†
10.11(19)†
10.12(24)†
(cid:3)
Amendment #3 to Supply and Manufacturing Agreement, dated December 20, 2016, by and between Cerus
Corporation and Porex Corporation.
(cid:3)
Amendment #4 to Supply and Manufacturing Agreement, dated January 31, 2017, by and between Cerus Corporation
and Porex Corporation.
(cid:3)
Amended and Restated Manufacturing and Supply Agreement, dated October 19, 2015, by and between Cerus
Corporation and Fresenius Kabi Deutschland GmbH.
(cid:3)
Manufacturing and Supply Agreement, dated September 30, 2008, by and between Cerus Corporation and NOVA
Biomedical Corporation.
(cid:3)
Amendment #1 to the Manufacturing and Supply Agreement, dated March 15, 2016, by and between NOVA
Biomedical Corporation and Cerus Corporation.
(cid:3)
Amended and Restated Supply Agreement, dated as of September 1, 2011, between Cerus Corporation and Ash
Stevens Inc.
(cid:3)
Addendum 1 to Amended and Restated Supply Agreement, dated August 1, 2013, by and between Cerus Corporation
and Ash Stevens, Inc.
108
(cid:3)
10.13(28)†
(cid:3)
Loan and Security Agreements
(cid:3)
Loan and Security Agreement, dated as of June 30, 2014, by and among Cerus Corporation and Oxford Finance LLC,
as collateral agent and a lender.
10.14(34)
(cid:3)
First Amendment to Loan and Security Agreement, dated January 30, 2015, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
(cid:3)
10.15†(33)
(cid:3)
Second Amendment to Loan and Security Agreement, dated September 29, 2015, by and among Cerus Corporation
and Oxford Finance LLC, as collateral agent and a lender.
10.16(37)
Third Amendment to Loan and Security Agreement, dated July 28, 2016, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
10.17
(cid:3)
Fourth Amendment to Loan and Security Agreement, dated October 25, 2016, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
(cid:3)
10.18(4)
(cid:3)
10.19(9)
(cid:3)
10.20(16)
(cid:3)
10.21(25)
(cid:3)
10.22(31)
(cid:3)
Real Estate Lease Agreements
(cid:3)
Standard Industrial/Commercial Single-Tenant Lease-Net, dated October 12, 2001 between Cerus Corporation and
California Development, Inc.
(cid:3)
Second Amendment to Standard Industrial/Commercial Single-Tenant Lease-Net, dated as of September 18, 2008
between Cerus Corporation and California Development, Inc.
(cid:3)
Letter to California Development, Inc. exercising option to extend the lease term from the Second Amendment to
Standard Industrial/Commercial Single-Tenant Lease-Net, dated as of September 18, 2008 between Cerus Corporation
and California Development, Inc.
(cid:3)
Real Property Lease, dated June 20, 2013, between Cerus Corporation and S. P. Cuff as Managing Partner of the
Redwoods Business Center LP.
(cid:3)
Letter, dated March 13, 2015 to Cuff Property Management exercising option to extend the lease term under the Real
Property Lease, dated June 20, 2013, between Cerus Corporation and S. P. Cuff as Managing Partner of the Redwoods
Business Center LP.
(cid:3)
(cid:3)
10.23(18)*
(cid:3)
10.24(23)*
(cid:3)
10.25(25)*
(cid:3)
10.26(17)*
(cid:3)
10.27(14)*
(cid:3)
10.28(23)*
(cid:3)
10.29(25)*
(cid:3)
10.30(33)*
(cid:3)
Employment Agreements or Offer Letters
(cid:3)
Employment Letter, by and between Cerus corporation and William M. Greenman, dated May 12, 2011.
(cid:3)
Addendum to Employment Agreement for William M. Greenman, dated December 5, 2012.
(cid:3)
Employment Letter, by and between Cerus Corporation and Laurence Corash, dated July 30, 2009.
(cid:3)
Employment Letter, by and between Cerus Corporation and Laurence Corash, dated March 2, 2010.
(cid:3)
Employment Letter for Kevin D. Green, dated May 1, 2009.
(cid:3)
Employment Letter, by and between Cerus Corporation and Chrystal Menard, dated October 19, 2012.
(cid:3)
Employment Letter, by and between Cerus Corporation and Carol Moore, dated December 14, 2007.
(cid:3)
Employment Letter, by and between Cerus Corporation and Richard J. Benjamin MBChB, PhD, FRCPath, dated
May 12, 2015.
(cid:3)
10.31(34)*
(cid:3)
(cid:3)
Settlement Agreement, by and between Cerus Europe B.V. and Caspar Hogeboom, dated December 23, 2015.
(cid:3)
109
10.32(34)*
(cid:3)
10.33(37)*
(cid:3)
10.34(1)*
10.35(1)*
10.36(1)*
10.37(32)*
10.38(2)*
10.39(3)*
10.40(5)*
10.41(32)*
10.42(20)*
10.43(20)*
10.44(20)*
10.45(36)*
10.46(36)*
(cid:3)
10.47(36)*
(cid:3)
10.48(23)*
10.49(11)*
10.50(13)*
10.51(26)*
10.52(35)*
(cid:3)
10.53(1)
10.54(12)
(cid:3)
10.55(21)
Consulting Agreement, by and between Cerus Corporation and Caspar Hogeboom, dated December 23, 2015.
(cid:3)
Employment Letter, by and between Cerus Corporation and Vivek Jayaraman, dated May 31, 2016.
(cid:3)
Stock Plans and Related Forms
(cid:3)
1996 Equity Incentive Plan.
(cid:3)
Form of Incentive Stock Option Agreement under the 1996 Equity Incentive Plan.
(cid:3)
Form of Nonstatutory Stock Option Agreement under the 1996 Equity Incentive Plan.
(cid:3)
Amended and Restated 1996 Employee Stock Purchase Plan, effective June 10, 2015.
(cid:3)
1998 Non-Officer Stock Option Plan.
(cid:3)
1999 Equity Incentive Plan, adopted April 30, 1999, approved by stockholders July 2, 1999.
(cid:3)
1999 Non-Employee Directors’ Stock Option Sub-Plan, amended December 4, 2002.
(cid:3)
Amended and Restated 2008 Equity Incentive Plan, effective June 10, 2015.
(cid:3)
Form of Option Agreement for employees under the Amended and Restated 2008 Equity Incentive Plan.
(cid:3)
Form of Option Agreement for non-employee directors under the Amended and Restated 2008 Equity Incentive Plan.
(cid:3)
Form of Restricted Stock Unit Agreement under the Amended and Restated 2008 Equity Incentive Plan.
(cid:3)
Cerus Corporation Inducement Plan.
(cid:3)
Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Cerus Corporation
Inducement Plan.
(cid:3)
Form of Restricted Stock Unit Grant Notice and Restricted Stock Award Agreement under the Cerus Corporation
Inducement Plan.
(cid:3)
Other Compensatory Plans or Agreements
(cid:3)
Bonus Plan for Senior Management of Cerus Corporation, as amended December 5, 2012.
(cid:3)
Cerus Corporation Change of Control Severance Benefit Plan, as amended.
(cid:3)
Form of Severance Benefits Agreement.
(cid:3)
Amended and Restated Non-Employee Director Compensation Policy.
(cid:3)
2015 and 2016 Executive Officer Compensation Arrangements.
(cid:3)
Other Material Agreements
(cid:3)
Form of Indemnity Agreement entered into between Cerus Corporation and each of its directors and executive officers.
(cid:3)
Form of Amended and Restated Indemnity Agreement, adopted April 24, 2009.
(cid:3)
Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, by and between Cerus Corporation and
Cantor Fitzgerald & Co.
(cid:3)
(cid:3)
110
10.56(27)
(cid:3)
10.57(35)
Amendment No 1. to Controlled Equity OfferingSM Sales Agreement, dated March 21, 2014, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
(cid:3)
Amendment No. 2 to Controlled Equity OfferingSM Sales Agreement, dated May 5, 2016, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
(cid:3)
10.58(16)†
(cid:3)
Restructuring Agreement, dated as of February 2, 2005, by and among Cerus Corporation, Baxter Healthcare S.A. and
Fresenius Kabi AG (successor-in-interest to Baxter Healthcare Corporation).
10.59(16)†
(cid:3)
License Agreement, dated as of February 2, 2005, by and between Cerus Corporation and Fresenius Kabi AG
(successor-in-interest to Baxter Healthcare S.A. and Baxter Healthcare Corporation).
10.60(6)†
Commercialization Transition Agreement, dated as of February 12, 2006, by and between Cerus Corporation and
Fresenius Kabi AG (successor-in-interest to Baxter Healthcare S.A. and Baxter Healthcare Corporation).
(cid:3)
12.1
(cid:3)
21.1
(cid:3)
23.1
(cid:3)
24.1
(cid:3)
31.1
(cid:3)
31.2
(cid:3)
32.1(38)
(cid:3)
101.INS
(cid:3)
101.SCH
(cid:3)
101.CAL
(cid:3)
101.DEF
(cid:3)
101.LAB
(cid:3)
101.PRE
(cid:3)
†
*
(1)
(2)
(3)
(4)
(cid:3)
Computation of Earnings to Fixed Charges.
(cid:3)
List of Registrant’s subsidiaries.
(cid:3)
Consent of Independent Registered Public Accounting Firm.
(cid:3)
Power of Attorney (see signature page).
(cid:3)
Certification of the Principal Executive Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
(cid:3)
Certification of the Principal Financial Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
(cid:3)
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
(cid:3)
XBRL Instance Document
(cid:3)
XBRL Taxonomy Extension Schema Document
(cid:3)
XBRL Taxonomy Extension Calculation Linkbase Document
(cid:3)
XBRL Taxonomy Extension Definition Linkbase Document
(cid:3)
XBRL Taxonomy Extension Label Linkbase Document
(cid:3)
XBRL Taxonomy Extension Presentation Linkbase Document
(cid:3)
Certain portions of this exhibit are subject to a confidential treatment order.
(cid:3)
Compensatory Plan.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-1 (File
No. 333-11341) and amendments thereto.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-8, dated
March 24, 1999.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-8, dated
August 4, 1999.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
111
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
ended December 31, 2001.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2003.
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2006.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on June 19, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2008.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on April 30, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on June 1, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended June 30, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on October 30, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2009.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on March 8, 2010.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on May 18, 2011.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2011.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on August 31, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2012.
(cid:3)
112
(23)
(24)
(25)
(26)
(27)
(28)
(29)
(30)
(31)
(32)
(33)
(34)
(35)
(36)
(37)
(38)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2012.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended September 30, 2013.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2013.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended March 31, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K, filed with the
SEC on March 21, 2014.
Incorporated by reference to the like-described exhibit to the Registrant’s Quarterly Report on Form 10-Q, for the
quarter ended June 30, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to Amendment No. 1 to the Registrant’s Quarterly Report on
Form 10-Q/A, for the quarter ended June 30, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Annual Report on Form 10-K, for the year
ended December 31, 2014.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant's Annual Report on Form 10-K, for the year ended
December 31, 2015.
(cid:3)
Incorporated by reference to the like-described exhibit to Registrant's Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2016.
Incorporated by reference to the like-described exhibit to the Registrant’s Current Report on Form 8-K (File No. 000-
21937), filed with the SEC on August 31, 2016
Incorporated by reference to the like-described exhibit to Registrant's Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2016.
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange
Commission, and is not incorporated by reference into any filing of the Registrant’s under the Securities Act of 1933,
as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form
10-K), irrespective of any general incorporation language contained in such filing.
113
[THIS PAGE INTENTIONALLY LEFT BLANK]
CERTIFICATION
Exhibit 31.1
I, William M. Greenman, certify that:
1.
2.
3.
4.
I have reviewed this annual report on Form 10-K of Cerus Corporation;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
b.
c.
d.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a.
b.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: March 8, 2017
/s/ WILLIAM M. GREENMAN
William M. Greenman
Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION
Exhibit 31.2
I, Kevin D. Green, certify that:
1.
2.
3.
4.
I have reviewed this annual report on Form 10-K of Cerus Corporation;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.
b.
c.
d.
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under
our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this
report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a.
b.
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial
information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: March 8, 2017
/s/ KEVIN D. GREEN
Kevin D. Green
Chief Financial Officer
(Principal Financial Officer)
CERTIFICATION
Exhibit 32.1
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), William M. Greenman, the Chief
Executive Officer of Cerus Corporation (the “Company”) and Kevin D. Green, the Chief Financial Officer of the Company, hereby
certify that, to the best of their knowledge:
1. The Company’s Annual Report on Form 10-K for the period ended December 31, 2016, and to which this Certification
is attached as Exhibit 32.1 (the “Annual Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the
Exchange Act, and
2. The information contained in the Annual Report fairly presents, in all material respects, the financial condition and
results of operations of the Company.
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 8th day of March, 2017.
/s/ WILLIAM M. GREENMAN
William M. Greenman
Chief Executive Officer
(Principal Executive Officer)
/s/ KEVIN D. GREEN
Kevin D. Green
Chief Financial Officer
(Principal Financial Officer)
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange
Commission and is not to be incorporated by reference into any filing of Cerus Corporation under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective
of any general incorporation language contained in such filing.
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Executive Management
William “Obi” Greenman
President and Chief Executive Officer
Chrystal Menard
Chief Legal Officer and General Counsel
Richard J. Benjamin, MBChB,
PhD, FRCPath
Chief Medical Officer
Laurence M. Corash, M.D.
Chief Scientific Officer
Kevin D. Green
Vice President, Finance and
Chief Financial Officer
Vivek K. Jayaraman
Chief Commercial Officer
Suzanne Margerum
Vice President, Manufacturing
and Operations
Carol Moore
Senior Vice President, Regulatory
Affairs and Quality
Nina Mufti
Vice President, Development
Lori L. Roll
Vice President, Administration
and Corporate Secretary
Yasmin Singh
Vice President, Program and
Portfolio Management
Adonis Stassinopoulos
Vice President, Global Scientific
Affairs and Research
Board of Directors
Daniel N. Swisher, Jr.
Chair of the Board,
Chief Executive Officer
Sunesis Pharmaceuticals, Inc.
Timothy B. Anderson
Former Senior Vice President
Baxter International, Inc.
Laurence M. Corash, M.D.
Chief Scientific Officer
Cerus Corporation
Bruce C. Cozadd
Chairman and
Chief Executive Officer
Jazz Pharmaceuticals plc
Corporate Information
Corporate Headquarters
2550 Stanwell Drive
Concord, California 94520
Telephone: (925) 288-6000
Fax: (925) 288-6001
www.cerus.com
European Headquarters
Stationsstraat 79-D
3811 MH Amersfoort
Netherlands
Telephone: 31 33 496 0600
Fax: 31 33 496 0606
Annual Report on Form 10-K
A copy of the company’s Annual
Report on Form 10-K as filed
with the Securities and Exchange
Commission is available without
charge on request to:
Investor Relations Department
Cerus Corporation
2550 Stanwell Drive
Concord, California 94520
Telephone: (925) 288-6137
Email: ir@cerus.com
Forward-looking Statement
L-R (back row) N. Mufti, L. Corash, S. Margerum, A. Stassinopoulos,
V. Jayaraman, C. Menard, R. Benjamin (front row) C. Moore, K. Green,
L. Roll, W. Greenman, Y. Singh
William “Obi” Greenman
President and
Chief Executive Officer
Cerus Corporation
Gail Schulze
Former Chairman
Zosano Pharma, Inc.
Corporate Counsel
Cooley LLP
San Francisco, California
Patent Counsel
Morrison & Foerster LLP
Palo Alto, California
Auditors
Ernst & Young LLP
Redwood City, California
Frank Witney, Ph.D.
Former President and
Chief Executive Officer
Affymetrix, Inc.
Registrar and Transfer Agent
Wells Fargo Shareowner Services
1110 Centre Pointe Curve, Suite 101
MAC N9173-010
Mendota Heights, MN 55120
Telephone: (800) 401-1957
Fax: (651) 450-4033
Stock Information
The Company’s common stock
traded on the NASDAQ Global
Market under the symbol: CERS
Annual Meeting of Stockholders
9:00 a.m., Wednesday, June 7, 2017
at Cerus Corporation
2550 Stanwell Drive
Concord, California 94520
This annual report includes forward looking statements regarding Cerus’ expectation that CBER will release final guidance on bacterial contamination of platelets in 2017, and
the contents of that guidance; the potential allowance for the interstate transport of INTERCEPT-treated platelet components by U.S. blood center customers that have submitted
biologics license applications (BLAs) to the FDA; Cerus’ expectation for market potential for a red blood cell and whole blood pathogen reduction system; Cerus‘ planned
INTERCEPT red blood cell CE Mark submission; and Cerus’ receipt of funding under the exercised funding options in the BARDA contract. Actual results could differ materially
from these forward-looking statements as a result of certain factors, including without limitation, risks associated with commercialization and market acceptance of, and customer
demand for, the INTERCEPT Blood System; the risk that Cerus’ blood center customers may be unable to obtain approvals by the FDA of BLAs they have submitted to the FDA
allowing for interstate transport of blood components processed using the INTERCEPT Blood System in a timely manner or at all, which could significantly delay or preclude
Cerus’ ability to successfully commercialize the INTERCEPT Blood System to those customers for the portion of their business involved in interstate commerce; risk 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; the uncertain nature of BARDA’s funding over which Cerus has no control as
well as actions of Congress and governmental agencies which may adversely affect the availability of funding under the BARDA contract and/or BARDA’s exercise of any potential
subsequent option periods, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be delayed or halted; and other factors
discussed in Cerus’ most recent filings with the Securities and Exchange Commission, including Cerus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2016.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this annual report. Cerus does not undertake any obligation to
update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
Cerus, INTERCEPT and INTERCEPT Blood System are trademarks of Cerus.
O U R M I S S I O N
Cerus will establish INTERCEPT as the standard of care
for transfused blood components globally and enable our
customers to do everything in their power to deliver safe and
effective blood products to patients.
At Cerus, we are proud of our unwavering focus on achieving
our mission, as reflected in our core values:
• The patient is our ultimate concern. We intend to make
INTERCEPT the standard of care for blood safety globally.
• We will be a dependable partner for all blood services to
allow them to achieve their important mission, concentrating
on ensuring the quality, supply, and operational efficiency
of our products. No other company will know blood center
operations better, nor provide better service.
• We operate as one team and resolve to attract and retain
the best people in the business. We operate in multiple
cultures and geographies and work in a coordinated,
mutually supportive fashion.
• Integrity, perseverance, scientific rigor, and urgency are core
to who we are.
www.cerus.com
2550 Stanwell Drive
Concord, CA 94520, USA
ph +1 (925) 288-6000
fx +1 (925) 288-6001