Partnerships
2018 Annual Report
Partnerships
American Red Cross
With our partnership with the American Red Cross, we are striving to bring pathogen-reduced platelets to
patients across the United States. The Red Cross is the largest supplier of blood components in the U.S.
INTERCEPT platelets are currently manufactured in 15 of the 23 Red Cross platelet manufacturing sites, with
more than half of those sites already receiving Biologics License Applications (BLA) approvals to distribute
INTERCEPT platelets across state lines. The Red Cross has been one of our earliest collaboration partners,
manufacturing INTERCEPT platelets under an Expanded Access Investigational Device Exemption in order
to provide pathogen-reduced platelets to patients in regions of the U.S. with outbreaks of chikungunya and
dengue virus in 2014. More recently, the Red Cross has become our latest manufacturing partner for supplying
INTERCEPT RBC for U.S. Phase 3 clinical trials.
OneBlood
Cerus has partnered with OneBlood to advance the clinical development of INTERCEPT for red blood cells.
OneBlood has built a state-of–the-art facility in Orlando Florida which is funded by our BARDA* contract to
manufacture INTERCEPT treated red blood cells in support of our Phase 3 U.S. clinical studies. OneBlood’s site
was the first INTERCEPT red blood cell manufacturing facility in the continental U.S. The close proximity to
many of the hospitals participating in our red blood cell clinical studies makes it an ideal location to support
our RBC clinical programs. In addition to our RBC partnership, OneBlood is an important INTERCEPT customer
manufacturing pathogen-reduced platelets at its blood collection centers in Florida.
Central California Blood Bank
In 2017, Central California Blood Center (CCBC) became our first collaboration partner to manufacture pathogen-
reduced cryoprecipitate. Pathogen-reduced cryoprecipitate represents a new business model for Cerus, one
which the company will be more directly involved in promotion to hospital customers while our manufacturing
partners will produce the cryoprecipitate. Based in Fresno California, CCBC has been providing INTERCEPT
platelets to hospitals in the central valley since 2017. In addition, CCBC produces INTERCEPT RBC for Cerus’ U.S.
clinical trials.
Fresenius Kabi
As the key supplier of INTERCEPT disposable kits, Fresenius Kabi is one of Cerus’ most important partners.
We have been working closely with Fresenius Kabi to ensure that blood centers, hospitals, and ultimately patients
have uninterrupted access to INTERCEPT kits. To this end, Fresenius Kabi, in collaboration with Cerus, is planning
to expand INTERCEPT kit manufacturing to a second site within its network to ensure supply chain integrity.
*The INTERCEPT Blood Systems for red blood cell project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.HHSO100201600009C.
Dear Shareholders,
In the context of Cerus’ long history and our enduring commitment to transform blood safety and
availability, there were two significant shifts in the U.S. in 2018 that set the stage for pathogen reduction
to become the standard of care. First, the FDA is now recognizing the role of pathogen reduction in
safeguarding the U.S. blood supply. Over the past several years, the FDA has been working to create
guidelines to reduce the risk of sepsis in patients receiving platelet transfusions. While each new draft
of the guidance to address bacterial contamination in platelets has featured a changing set of testing
options, pathogen reduction has been consistently featured as an option to reduce the risk of transfusion
related sepsis that removes the need for bacterial testing. The FDA is planning to issue the final guidance
document in 2019, which could accelerate the rate of adoption of pathogen-reduced platelets in the U.S.
market. The second important event in 2018 was the movement within the U.S. transfusion community led
by the American Red Cross to adopt value-based pricing to enable innovation and garner a premium for
novel blood components such as pathogen-reduced platelets. Over the last decade, blood components
have been increasingly commoditized, so hospital willingness to pay a premium for INTERCEPT is
challenging industry pricing conventions at an important time. These two significant changes to the
transfusion medicine landscape provided a backdrop for a successful 2018 and a foundation for expected
growth in 2019 and beyond.
Approaching Standard of Care in Western EU
France became the latest country to adopt INTERCEPT as the standard of care. As a result, currently every
patient who receives a platelet transfusion in France benefits from our pathogen reduction technology.
Based on the number of INTERCEPT kits sold to Établissement Français du Sang, the French National Blood
Service, this equates to approximately one thousand patients receiving INTERCEPT treated platelets every
day in France. We anticipate adoption of INTERCEPT platelets increasing in other EU member states and
specifically in Germany where nationwide reimbursement for pathogen-reduced platelets is now in place.
Increasing U.S. Adoption
In the U.S., demand for INTERCEPT platelets continues to strengthen
as a result of our commercial team’s efforts to increase awareness on
the benefits of pathogen-reduced platelets, as well as increasing market
awareness of the pending FDA guidance for improved platelet component
transfusion safety. During 2018, we estimate that U.S. market penetration
doubled from under 5% in 2017 to nearly 10%. Currently, over 175 hospitals
in the U.S. are now transfusing INTERCEPT treated platelets, including
10 of the Top 20 “Best Hospitals” according to the U.S. News and World
Report. The American Red Cross has continued its leadership role by
taking a strong stand in support of the adoption of innovative technologies
to improve blood safety and availability. As the Red Cross continues the
roll-out of INTERCEPT across its production centers, with the associated
site regulatory approvals to enable nationwide distribution of INTERCEPT
platelets, they are increasingly able to meet the demand from their hospital
customers for full conversion to a pathogen reduced platelet inventory.
Expansion into Biologics
Efforts to expand our product line beyond our core INTERCEPT portfolio for
treating blood components continue with the development of pathogen-reduced
cryoprecipitate. Cryoprecipitate is commonly used as a source of fibrinogen and
factor XIII to control massive bleeding in patients with traumatic injury, maternal
hemorrhage or undergoing complex cardiovascular surgery. Conventional
cryoprecipitate is stored frozen and is therefore not readily available when it is most
critically needed. The short 4-6 hour shelf-life of conventional cryoprecipitate after
thawing also has a significant impact on overall utility, leading to wastage rates
estimated as high as 33%. The pathogen-reduced cryoprecipitate being developed
at Cerus is designed to extend the post-thaw shelf life to 5 days, enabling the
product to be thawed in advance of major bleeding events. We are encouraged by
our internal market research, which continues to indicate a high degree of physician
interest in the product. Development timelines for pathogen-reduced cryoprecipitate are tracking to plan and we are
planning to submit for U.S. regulatory approval in the second half of 2019, which could set the stage for potential U.S.
approval and commercialization in 2020.
Pathogen-Reduced
Cryoprecipitate Market Potential
*Source: Internal Estimates
Red Blood Cells
We finished 2018 with an important milestone in our INTERCEPT red blood cell program with the CE Mark submission
in December. The submission represented the culmination of years of effort to complete the full INTERCEPT portfolio
of products. TÜV SÜD, our regulatory notified body, is reviewing the file, which will then be reviewed by the Irish Health
Products Regulatory Authority, the competent authority. In the U.S., we made meaningful strides in our red blood cell
clinical program in 2018 and expanded the number of participating clinical sites into the continental U.S. to accelerate
the rate of enrollment in our RedeS study. In addition, in December, we initiated enrollment in ReCePI, our second
phase 3 U.S. clinical study, which is designed to assess the safety and efficacy of INTERCEPT red blood cells in patients
undergoing complex cardiac surgery. To be able to submit for a PMA approval in the coming years, we are in ongoing
discussions with the FDA with regard to their requirement for chronic transfusion experience to allow for a broad clinical
use indication at the time of approval.
Financial Strength
We exited 2018 on solid financial footing with approximately $118 million of cash, cash equivalents, and short-term
investments on the balance sheet. We strengthened our cash position with a new debt facility in March 2019, which is
expandable up to $90 million to fund our growth initiatives as well as our working capital needs associated with the
growth of our business and increasing inventory demands.
The commitment of the Cerus team to improve the safety and availability of blood components on a global scale
continues to inspire me on a daily basis. Without their tireless effort and dedication to improve availability to safe and
effective blood components, we would not have achieved the important milestones this past year. Our energy and efforts
are increasingly focused on ensuring that Cerus can scale its operations efficiently with the expected growth in the years
to come. In closing, on behalf of all Cerus employees worldwide, we appreciate the continued support of our shareholders
as we advance our mission to make INTERCEPT the global standard of care for transfused blood components.
Sincerely,
William “Obi” Greenman
President and Chief Executive Officer
April 26, 2019
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(cid:3) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the fiscal year ended December 31, 2018
OR
(cid:4) 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:3) No (cid:4)
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:4) No (cid:3)
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:3) No (cid:4)
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes (cid:3) No
(cid:4)
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:4)
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an
emerging growth company. See the definitions of “large accelerated filer,”, “accelerated filer,”, “smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
Large accelerated filer (cid:3)
Accelerated filer (cid:4)
Non-accelerated filer (cid:4)
Smaller reporting company (cid:4) Emerging growth company (cid:4)
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. (cid:31)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:4) No (cid:3)
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 $873 million. (1)
As of February 15, 2019, there were 136,953,123 shares of the registrant’s common stock outstanding.
Portions of the registrant’s definitive proxy statement in connection with the registrant’s 2019 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, 2018, 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 $6.67 per share on June 30, 2018. Excludes 2.6 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, 2018.
[THIS PAGE INTENTIONALLY LEFT BLANK]
FORM 10-K
For the Fiscal Year Ended December 31, 2018
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.
Item 16.
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......................................................................................................................
Exhibits and Financial Statement Schedules...............................................................................................................
Form 10-K Summary...................................................................................................................................................
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2
16
51
51
51
51
52
53
54
67
67
67
68
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71
71
71
71
71
72
78
SIGNATURES ................................................................................................................................................................................
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[THIS PAGE INTENTIONALLY LEFT BLANK]
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:
•
•
•
•
•
•
•
•
•
•
•
•
•
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, or U.S., and foreign laws, regulations and
regulatory requirements;
our ability to successfully complete development, receive regulatory approvals and commercialize extended storage
cryoprecipitate or other plasma derived biological products using the INTERCEPT Blood System;
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 timing of CE Mark approval 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
1
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
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 the U.S., we
successfully completed a Phase 2 recovery and lifespan study in 2014. We successfully completed our European Phase 3 clinical trial
of our red blood cell system for acute anemia patients, and in January 2018, we reported that the primary efficacy and safety endpoints
were met in our European Phase 3 clinical trial for chronic anemia patients. We filed for CE Mark approval of the red blood cell
system in December 2018.
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
• 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
• U.S. post-approval haemovigilance study enrolling patients
INTERCEPT Blood System—Plasma
INTERCEPT Blood System—Red Blood Cells
• 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
• Extended storage cryoprecipitate supplement under existing FDA approval
planned for 2019
• Phase 1 clinical trial completed in 2010
• U.S. Phase 2 recovery and lifespan study completed in 2014
• U.S. Phase 3 clinical trial, known as the RedeS study, enrolling patients
• U.S. Phase 3 acute anemia clinical trial, known as the ReCePI study, enrolling
patients
• Additional U.S. studies also planned
• European Phase 3 acute anemia clinical trial completed in 2014; European Phase
3 chronic anemia clinical trial completed in 2017
• European CE Mark submitted in December 2018
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 FDA approval in the U.S., 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 collected and
stored in 100% plasma or InterSol 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 two post-approval studies - a haemovigilance study to evaluate the incidence of
acute lung injury following transfusion of INTERCEPT-treated platelets; and a recovery study of platelets treated with the platelet
system that is currently in discussion with FDA. The first patient enrolled in the haemovigilance 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. In 2018, the FDA granted Breakthrough Device Designation to our proposed extended
storage cryoprecipitate after treatment with INTERCEPT. We plan to submit a supplement to our existing INTERCEPT plasma PMA
license for such a product.
Our commercial efforts in 2019 will largely be focused on enabling blood centers that are using INTERCEPT to optimize production
and increase the number of platelet and plasma units produced and made available to patients. In addition, we will continue to develop
awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including conventional, un-treated
components. To enable broader patient access to INTERCEPT-treated products 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 and received their interstate licenses, or BLAs. Until BLAs are obtained, U.S. blood centers will be limited to sell the
applicable INTERCEPT-treated blood components to hospital customers within the state in which the INTERCEPT-treated platelets
or plasma are processed. Further, the hospital customers of these blood centers may need complete changes to their administrative
processes of generating internal tracking codes to integrate INTERCEPT-treated products into their inventories prior to receiving
3
INTERCEPT-treated components. 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. Although available in Europe, we will need to provide additional data to the FDA for a triple dose configuration of the
platelet system to treat platelet donations with such processing parameters. In addition, 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. While available in Europe and other regions
around the world, 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 application, or PMA, supplement. In addition, we plan to perform in vitro studies and seek a
PMA supplement to use our plasma system to produce extended-storage cryoprecipitate and possibly other plasma derived biological
products. 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.
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 3 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, or RBCs, 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 3 clinical trials, we found that we had met the primary
endpoint in the clinical trial for acute anemia. We evaluated the antibodies detected and developed process changes to diminish the
likelihood of antibody reactivity in RBCs treated with our modified process. Accordingly, we received authorization from European
regulators to proceed with Phase 3 clinical trials for acute anemia and, separately, chronic anemia. We announced the successful
completion of our Phase 3 clinical trial of the red blood cell system for acute anemia patients in January 2015 and for chronic anemia
patients in January 2018. We submitted our application for CE Mark approval in December 2018. We do not expect to receive any
regulatory approvals of our red blood cell system in the next 15 months, if ever.
In January 2015, we announced that the completed European Phase 3 clinical trial of RBCs 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 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 3 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. Additionally, in January 2018, we announced that the European Phase 3
clinical trial of chronic anemia evaluating INTERCEPT-treated RBCs in thalassemia patients met its primary efficacy and safety
endpoints. We understand that while the data generated from our European Phase 3 clinical trials may be sufficient to receive CE
Mark approval, we may need to generate additional safety data from commercial use 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 2 recovery and lifespan study in 2014. In 2017, we initiated a double-blind Phase 3
clinical study, known as the RedeS study, to assess the safety and efficacy of INTERCEPT-treated RBCs when compared to
conventional RBCs in regions impacted by the Zika virus epidemic. The RedeS study has been expanded to other areas at risk for
transfusion-transmitted infections due to the Zika virus, and may include such areas as Texas and Florida. The first stage of the trial is
a double-blind, controlled, parallel group trial where 600 adult patients will be randomized to receive up to 28 days of transfusion
support with INTERCEPT-treated RBCs or conventional RBCs, with a primary endpoint of hemoglobin increment following
transfusion. In a second optional stage, up to 20,000 patients would receive RBC transfusion support with up to 50,000 RBC units in
an open-label, single-arm treatment use study. Also in 2017, we received investigational device exemption, or IDE, approval from the
FDA to initiate a Phase 3 clinical trial, known as the ReCePI study, that is designed to evaluate the efficacy and safety of
INTERCEPT-treated RBCs in patients requiring transfusion for acute blood loss during surgery. A total of 600 patients are expected
to be enrolled in the ReCePI study in up to 20 participating sites in the U.S. Patients will be randomized on a 1:1 basis with patients in
the treatment arm transfused with RBCs treated with INTERCEPT and patients in the control arm transfused with conventional RBCs.
The primary efficacy endpoint is the proportion of patients experiencing acute kidney injury as an assessment of RBC efficacy in
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providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels within 48 hours
after the surgery. Enrollment in the ReCePI study recently began. The RedeS and ReCePI studies are being funded as part of our
agreement with BARDA. In addition to successfully conducting and completing the RedeS and ReCePI studies, we will need to
successfully conduct and complete an additional Phase 3 clinical trial for chronic anemia 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 an additional Phase 3 clinical trial for chronic anemia. 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 an additional Phase 3 clinical
trial for chronic anemia. 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 RBCs 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.
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, 2018, 2017 and 2016 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
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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.
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.
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 disposable kits for the platelet and plasma systems and rely 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. Under our amended and restated manufacturing and supply agreement we entered into with Fresenius in
October 2015, Fresenius is obligated to sell, and we are obligated to purchase, finished disposable kits for our platelet, plasma and red
blood cell systems. The 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 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 of €5.5 million in 2019. The term of the 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 the compound adsorption devices used in our platelet and plasma disposable kits are manufactured by Porex
Corporation, or Porex. In April 2017, we entered into an amended and restated manufacturing and supply agreement with Porex for
the continued supply of the compound adsorption devices. Porex is our sole supplier for certain components of and manufacturing of
the compound adsorption devices. Under the amended and restated Porex agreement, we are no longer subject to a minimum annual
purchase requirement; however, Porex has the right to terminate the agreement, upon twelve months’ prior written notice, if annual
production falls below a mutually agreed threshold. If not sooner terminated, the amended and restated Porex agreement expires on
December 31, 2019, but could renew for an additional two years. Although we are actively seeking to develop alternative
manufacturers and components, commercially viable alternatives are likely several years away.
We also have an amended and restated supply agreement with Brotech Corporation d/b/a Purolite Company, or Purolite, for the supply
of raw materials used to make the compound adsorption devices. 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.
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 are
currently negotiating an amendment with Nova for the purchase of components that may become obsolete and for other components to
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build illuminators. Nova will likely require us to prepay for these components before they are converted into finished illuminators over
a protracted period. 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 subject to
minimum annual purchase requirements. We have incurred these maintenance fees in the past. The term of the amended
manufacturing and supply agreement with Ash Stevens automatically extended at the end of 2017 and now continues until
December 31, 2019, 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 those raw material 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, due to
obsolescence, certain plastics used to make our INTERCEPT disposable kits are no longer available. As a result, we and our
manufacturers were required to identify alternate plastics for the manufacture of our disposable kits, and while we have received both
CE Mark and FDA approval of the alternate plastics used in the platelet system, we will need to obtain approval for the plasma
product before we can utilize them in commercial manufacturing. Any acceleration of demand for our plasma products prior to
receiving approval may result in a run-out of the obsolete plastic and in-turn, an inability for us to meet that potential increased
demand.
Certain regions that we sell into or may sell into in the future may give priority to those products that are manufactured locally in their
jurisdiction. Our failure to meet these local manufacturing conditions may prevent us from successfully commercializing our product
in those geographies. In addition, should we choose to manufacture locally in those jurisdictions, we would likely incur additional
costs, may be unable to meet our quality system requirements or successfully manufacture products, and such activities will be a
distraction from our current focus and operations. We have no experience manufacturing or working with manufacturers outside of
our current manufacturing footprint.
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 with the American Red Cross. 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 our obtaining CE
Mark approval allows 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 two blood centers have
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. INTERCEPT-treated platelets received national reimbursement in Germany
in 2018 at a premium to untreated platelets. While this dynamic has the potential to generate economic value for blood centers in
Germany, we cannot ensure that blood centers will understand or act 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. Following the inclusion of pathogen-inactivated platelets for national reimbursement by the German Institute for the
Hospital Remuneration System as of January 1, 2018, German customers who do not currently have an approved marketing
authorization application, or MAA, will first need to obtain one before using the INTERCEPT Blood System. The review period for a
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new MAA can be up to twelve months following submission and we cannot predict which German customers or potential customers
will obtain an MAA. Without broad approvals of MAA applications obtained by potential German customers, our ability to
successfully commercialize INTERCEPT in Germany will be negatively impacted, which may adversely affect our results of
operations and financial results.
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. In July 2017, we entered
into new agreements with the EFS to supply illuminators, platelet and plasma disposable kits. While the EFS has standardized
production of its platelets using the INTERCEPT Blood System, we cannot provide any assurance that the national deployment of
INTERCEPT in France will be sustainable, or that we will be able to secure any subsequent contracts with EFS or that the terms,
including the pricing or committed volumes, if any, of any future contract will be equivalent or superior to the terms under our current
contract. If we are unable to successfully support EFS’ national adoption of the INTERCEPT Blood System for platelets or 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 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. 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. Before the
Japanese Red Cross 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.
In 2018, the FDA granted Breakthrough Device Designation to our proposed extended storage INTERCEPT-treated cryoprecipitate
(“INTERCEPT cryo”) with. We do not know and cannot assure that such designation will expedite or ensure approval of such a
product in the near term or ever. We have entered into manufacturing agreements with certain blood centers to produce INTERCEPT
cryo for us. In order to successfully commercialize INTERCEPT cryo, we will need to influence the market and sell directly to
hospital users of cryoprecipitate and may need to add resources to our existing commercial teams to commercialize INTERCEPT
cryo. We do not know if INTERCEPT cryo will be perceived as economically attractive to hospital customers or at what price, if any,
or if the investment needed to sell INTERCEPT cryo will be sustainable should we obtain approval of the PMA supplement for such a
product.
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, 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
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, commercial use of our products may not be covered by governmental or
commercial third party payors for health care services and may never be covered. 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 Procedure Coding System, or HCPCS. The reimbursement pricing for
our products under HCPCS is driven by actual costs charged to hospitals for INTERCEPT-treated components. Even though blood
components treated with our products are approved for reimbursement by governmental or commercial third party payors, including
under HCPCS codes, the costs and expenses related to use of the INTERCEPT Blood System are not 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
8
reimbursement structure, hospital billing and/or reimbursement for these products could be impacted, thus negatively impacting
hospitals’ acceptance and uptake of our products.
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 hospital affairs professionals, to help educate hospitals and physicians on our products, clinical
trial history and publications. We have a small group of individuals which we may add to in the future to market and sell INTERCEPT
cryo in the U.S. 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 the past, we have transitioned 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.
Government Contract
Revenue from the cost reimbursement provisions under our government contract varies by year. A portion of our government contract
revenue is subject to renegotiation of reimbursement rates or termination of the contract 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 “Item 15—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,
2018, 2017 and 2016. 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 U.S. based blood centers and many have more commercial resources than we do. In addition,
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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 known to us to be 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 3 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 and has recently completed a clinical trial
of its whole blood system in Ghana, receiving a Class II CE Mark. Terumo BCT’s products may offer certain competitive advantages
over our INTERCEPT Blood System.
In the U.S., INTERCEPT-treated plasma faces competition from Octapharma AG, which is currently commercializing treated fresh
frozen plasma for certain indications in the U.S., 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.
Terumo BCT’s platelet and plasma pathogen reduction product may be viewed as favorable 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
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, 2018, we owned 5 issued or
allowed U.S. patents and approximately 65 issued or allowed foreign patents related to the INTERCEPT Blood System. Our patents
expire at various dates between 2019 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 2019 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
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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 recently expired 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 have infringed 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. 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 shelf lives from 18 to 24 months. 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 sheets, 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 or conversely, may be insufficient to meet an increase in demand for our products.
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 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.
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. As we look ahead, we anticipate that the regulatory submission processes related to planned
PMA supplements for the platelet and plasma systems 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. We are pursuing a PMA
supplement for INTERCEPT cryo which will require that we perform certain tests and in vitro studies which will add to our research
and development costs. In the U.S., we expect to incur increasing research and development expenses associated with pursuing
licensure of the red blood system including the RedeS study, the ReCePI study and an additional Phase 3 clinical trial for chronic
anemia in the U.S., in vitro studies, and other 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 reimbursed 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
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Report on Form 10-K for costs and expenses related to research and development, and other financial information for the years ended
December 31, 2018, 2017 and 2016.
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 renewal of the approval for CE Mark for the platelet system was received
in 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 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.
The FDA has 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 as an alternative to gamma irradiation for prevention of transfusion-associated graft
versus host disease, or TA-GVHD. The FDA has also approved the plasma system for ex vivo preparation of pathogen-reduced, whole
blood derived or apheresis plasma in order to reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion
and as an alternative to gamma irradiation for prevention of TA-GVHD. 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. In
addition, we plan to perform in vitro studies and seek a PMA supplement to INTERCEPT cryo and possibility other plasma derived
biological products.
As a condition to the FDA approval of the platelet system, we are required to conduct two post-approval studies of the platelet system
studies - a haemovigilance study to evaluate the incidence of acute lung injury following transfusion of INTERCEPT-treated platelets;
and a recovery study of platelets treated with the platelet system that is currently in discussion with FDA. 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
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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 submissions 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 understand that certain plastics used to make INTERCEPT disposable kits are no longer available. As a result, we and our
manufacturers have identified alternate plastics and we have received CE Mark and FDA approval for our platelet product using the
alternate plastics but will need to qualify and validate those plastics for our plasma product before we can utilize them in commercial
manufacturing. We will need to obtain FDA approval of the alternate plastics before kits manufactured with those alternate plastics
can be commercially sold in the U.S. 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 or foreign regulatory approvals of new platelet and plasma product configurations or the new plastics 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
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 FDA or other foreign regulatory authorities may require us to recall products as a result of adverse events or
production problems. Additionally, we are required 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. Any significant product change that we make may require amendments or supplements to those
site-specific licenses that a U.S.-based blood center customer has obtained. 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
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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 1, Phase 2 and Phase 3 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.”
U.S. Health Care Reimbursement and Reform
Our ability to commercialize our products successfully in the U.S. will depend in part on the extent to which coverage and appropriate
reimbursement levels for the cost of the products and related treatment are obtained. The INTERCEPT Blood System is currently sold
to U.S. based blood collection entities. Because our products are not directly reimbursable by governmental or commercial third party
payors, adoption of the INTERCEPT Blood System will, in part, require coverage and adequate reimbursement to be provided for the
procedures and treatments which utilize INTERCEPT-processed blood products. There is no uniform policy of coverage and
reimbursement among third-party payors, as such, coverage and reimbursement can differ significantly from payor to payor. Even if
favorable coverage and reimbursement status is attained for a particular procedure or treatment, less favorable coverage policies and
reimbursement rates may be implemented in the future. If the costs to hospitals for INTERCEPT-processed blood products acquired
from blood collection entities cannot be easily, readily, or fully incorporated into the hospital’s existing coverage and reimbursement
structure, adoption of our products may be negatively affected.
In the U.S., there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results
of operations. For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act, or collectively, the ACA, and ongoing cost saving efforts may have an impact on our ability to profitably
commercialize the INTERCEPT Blood System in the U.S. and elsewhere. The ACA and other health care reform in the 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. Since January 2017,
President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of
the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has
considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive
repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties as of January 1, 2019 for
not complying with the ACA’s individual mandate to carry health insurance and delaying the implementation of certain ACA-
mandated fees, including the imposition of the medical device excise tax on non-exempt medical devices through December 31, 2019.
On December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual
mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017. While the Texas U.S. District Court Judge, as well
as the Trump administration and CMS, have stated that the ruling will have no immediate effect pending appeal of the decision, it is
unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the ACA.
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, 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” 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.”
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Employees
As of December 31, 2018, we had 240 employees, 92 of whom were engaged in research and development and 148 of whom were
engaged in selling, general and administrative activities. Of the 148 employees engaged in selling, general, and administrative
activities, 43 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. The broad successful commercial adoption of any product, particularly involving novel technologies, is often dependent upon the
seller earning a level of trust from and familiarity with customers, which can take time to develop. In addition, although we received
FDA approval of our platelet and plasma systems in December 2014, our U.S. commercial efforts in 2019 will largely be focused on
enabling blood centers that are using INTERCEPT to optimize production and increase the number of platelet and plasma units
produced and made available to patients and continuing to develop 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 timely, 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. Similar to our experience in foreign jurisdictions, some potential
customers in the U.S. have chosen to first validate our technology or conduct other pre-adoption 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. Delays in any
customer obtaining their BLA approval 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. In addition,
significant changes to our product or the way in which our product is used may require that those customers file supplements or
amendments to their site-specific licenses from CBER to continue to sell blood components processed using the INTERCEPT Blood
System. 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 until they obtain the BLA licenses under the manner in which they use our product. 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 product
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, test and obtain
regulatory approval for 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;
availability of donors;
regulatory and licensing requirements, including the CBER licensing process that U.S.-based blood centers are required to
follow in order to obtain and maintain 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 Procedure
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, the ability of our 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;
successful customer transition to the disposable kits manufactured with the alternate plastics, as approvals are obtained;
dependency upon any third party manufacturer that supplies products required by blood centers to process and store blood
components consistent with our approved specifications and claims, including but not limited to, apheresis collection
devices, disposable blood bags and reagents, and platelet additive solution, or PAS;
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 recently expired 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 have infringed 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 have
infringed any valid claim of this patent, we may, among other things, be required to pay damages.
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 increase market demand, 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, or if the use of our product in any way constrains the availability of blood due to
platelet loss, or our customers or prospective customers believe that the loss of platelets reduces the efficacy of the transfusable unit,
or our process requires changes in blood center or clinical regimens, prospective customers may not adopt our platelet system.
Additionally existing customers may not believe they can justify any perceived operational change or inefficiency by itself or in
conjunction with a blood component availability shortage. Certain customers that attempt to optimize collection practices from
individual donors in order to increase the volume of transfusable units that can be treated with INTERCEPT from those collections
may experience a less optimized yield as a result of adopting INTERCEPT as compared to collecting 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
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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
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 1 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. Accordingly, the study was not designed to generate any data on the efficacy of INTERCEPT to inactivate the Ebola
virus, and we still do not have any clinical or commercial data on the efficacy of INTERCEPT to inactivate the Ebola virus, and
therefore, we 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 or others 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. For example, in connection with the nation-wide deployment of INTERCEPT platelets in France, our customer,
Établissement Français du Sang, or EFS, has encountered instances of leakage in the disposable kits. Although the relative number of
reports is not disproportionate to the number we have seen in other markets, because of the high number of new sites, and the high
utilization rates throughout France, the absolute number of incidents has triggered a report to the French National Agency for
Medicines and Health Products Safety, or ANSM. We are working with EFS to investigate and determine root cause and imputability
in an effort to resolve the issue, and if we are unable to successfully resolve the issue, EFS may stop using our products. In addition,
the U.S. is currently experiencing a shortage of platelet components in many markets. Should customers feel that INTERCEPT
treatment has a negative impact on the number of transfusable platelet units able to be manufactured from available donors, our ability
to convince a blood center to treat increasing proportions of its platelet units may be negatively impacted. Moreover, 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
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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. In addition, customers may require certain changes to our products
for any number of reasons. Complying with such requests may prove costly, and may create complexities surrounding the
manufacturing of the kits, compliance with regulatory authorities, blood center usage, or inventory management. Conversely, failure
to comply with such requests from customers may result in damage to our relationship or the potential loss of customer business.
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
exacerbated by economic legislation in certain countries and by proposals by legislators at both the federal and, in some cases, 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, commercial use of our products may not be covered by governmental or
commercial third party payors for health care services and may never be covered. Even if we received national reimbursement for our
products, we may not be able to convince blood center customers to change their operating practices and produce INTERCEPT-
treated platelets and plasma. In the U.S., we 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 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. Governmental or third party payors may change
reimbursement rates, year over year, or in reaction to submitted claims for reimbursement of costs and expenses related to blood
components treated with INTERCEPT. If the costs to the hospital for INTERCEPT processed blood products cannot be easily, readily,
or fully incorporated into the existing reimbursement structure, or if reimbursement rates are decreased in any given year for blood
components treated with INTERCEPT, 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. We cannot guarantee the long-term 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’ and other customers’ demands, which could result in a loss of product 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 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.
Obtaining these approvals requires support and coordination from local blood centers, and may take a significant period of time to
obtain, if ever. 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. Following the inclusion of pathogen-inactivated
platelets for national reimbursement by the German Institute for the Hospital Remuneration System as of January 1, 2018, German
customers who do not currently have an approved marketing authorization application, or MAA, will first need to obtain one before
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using our product. The review period for a new MAA can be up to twelve months following submission and we cannot assure that any
of the potential German customers submitting a new MAA will obtain it. Without broad approvals of MAA applications obtained by
potential German customers, our ability to successfully commercialize INTERCEPT in Germany will be negatively impacted, which
may adversely affect our results of operations and financial results.
In July 2017, we entered into new agreements with the EFS to supply illuminators and platelet and plasma disposable kits. While the
EFS has standardized production of its platelets using the INTERCEPT Blood System, we cannot provide any assurance that the
national deployment of INTERCEPT in France will be sustainable or that we will be able to secure any subsequent contracts with EFS
or that the terms, including the pricing or committed volumes, if any, of any future contract will be equivalent or superior to the terms
under our current contract. If we are unable to successfully support EFS’ national adoption of the INTERCEPT Blood System for
platelets or 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. Our existing contract with the EFS does not contain purchase volume commitments and
as such, we may see variability in purchase levels or an altogether cessation. We cannot assure that the EFS will use the INTERCEPT
Blood System for plasma at historical levels or at all.
In addition, we understand that the EFS will want to inspect and test samples of each lot that they anticipate purchasing from us prior
to accepting the products shipped to fulfill orders. We may have little insight into the time to test, testing methods, testing conditions
or ultimate results. Other customers may require similar conditions of purchase. Testing may have a negative impact on our ability to
recognize product revenue either due to the time it takes to test and approve the release of a shipment or if the customer experiences
problems with testing or if testing results are outside of the customer acceptance criteria.
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.
Significant increases in demand may occur given the concentrated nature of many of the largest potential customers and the potential
for a mandate by public health agencies to adopt pathogen reduction technologies. Should those customers choose to adopt and
standardize their production on the INTERCEPT Blood System or be required to adopt and standardize on the INTERCEPT Blood
System, our ability to meet associated increases in demand may be constrained due to a variety of factors, including supply issues,
manufacturing disruptions, availability of disposable kits manufactured from the obsolete plastic materials in jurisdictions that have
not approved the alternate plastics, or other obsolescence of parts, among others. If we encounter such disruptions or supply shortages,
we may have to allocate available products to customers, which could negatively impact our business and reputation or cause those
customers to look for alternatives to the INTERCEPT Blood System.
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
altogether eliminate any 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
product revenue. We expect our losses to continue at least until we are able to gain widespread commercial adoption, which may
never occur. We expect to invest in research and development costs as we pursue a PMA supplement for INTERCEPT cryo and hire
employees and possibly retain contract resources to build a specialized commercial effort to sell that product directly to hospitals. 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 approval of our recent 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.
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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.
The sales of our products in Europe and CIS countries are denominated in Euros and other non-U.S. currencies. As a result, we are
exposed to foreign exchange risk, and our results of operations have been and will continue to be impacted by fluctuations in the
exchange rate between the U.S. dollar and other currencies, in particular the Euro. 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.
In the past, a meaningful amount of our product revenue has come from sales to our distributor in Russia and other CIS countries.
Weakness and/or instability in 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 and may in the future significantly devalue the Russian Ruble and other
CIS currencies and have had 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. For example, in 2017 and again in 2018, the Trump administration imposed sanctions against Russia, including sanctions
targeting certain Russian individuals and entities. It is possible that Congress will consider or pass legislation imposing additional
sanctions. 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, its involvement in Syria or otherwise, if worldwide oil prices weaken 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 or never
recover to historical levels. Similarly, weak or unstable 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.
Moreover, the Trump administration has recently imposed tariffs on certain U.S. imports, and Canada, the E.U., China and other
countries have responded with retaliatory tariffs on certain U.S. exports. We cannot predict what effects these and potential additional
tariffs will have on our business, including in the context of escalating trade tensions. However, these tariffs and other trade
restrictions could increase our operating costs, reduce our gross margins or otherwise negatively impact our financial results.
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 product 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;
manufacturing;
labeling;
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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. In addition, jurisdictions may differ in the definition of what constitutes a transfusable unit of platelets. We have developed
our products with the aim to standardize the volume of platelets treatable by our system, wherever possible, which may not be
accepted by all regulators or customers, may require additional data to support approval or which may not produce optimal
transfusable blood components. For example, in certain jurisdictions, our approved label claims and the definition of a viable platelet
unit for transfusion may allow for a significantly lower or higher platelet count per volume than other jurisdictions may allow. This
variability in platelet count per volume may result in differences in platelet quality once processed and stored using INTERCEPT, and
if customers experience sub-optimal platelet quality following INTERCEPT treatment, they may limit their adoption of INTERCEPT
or consider adoption of competing blood safety technologies over INTERCEPT. In addition, 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 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 continue to experience 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 ethics 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, terrorist
activity or concerns over employee safety. We have in the past restricted and may again in the future need to restrict travel to certain
clinical trial sites for monitoring site visits or to otherwise manage the trial due to state department issued travel warnings and
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restrictions. Significant delays in clinical testing could also materially impact our clinical trials. For example, enrollment and progress
of the RedeS study was impacted in Puerto Rico immediately following the hurricanes in 2017. We cannot be certain that further
delays in the RedeS study will not occur. 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
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 European Phase 3 red blood cell system trial in chronic anemia
patients and may impact other studies. 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 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 customers of blood centers are
reluctant to accept conventional, non-INTERCEPT-treated products once INTERCEPT products become available to them. 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 or
processing 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 such 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 and 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. In Germany, blood centers need to obtain
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marketing authorizations before they can submit for reimbursement or sell to hospitals. Significant product changes or changes in the
way customers use our products may require amendments or supplemental approvals to licenses already obtained. Blood centers that
do submit applications, supplements or amendments 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.
Red Blood Cell System
While we have recently submitted for CE Mark approval of our red blood cell system, it 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 us to conduct
additional clinical trials or 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, 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. We must be able to demonstrate stability of our active compounds manufactured under
cGMP which meets release specifications. We have not been able to demonstrate that our product manufacturers or we are able to
meet those requirements. If we are unable to demonstrate an ability to manufacture according to our specifications under cGMP with
acceptable stability data, we may be unable to satisfy regulatory questions and requirements which could prevent or delay the potential
approval of or our ability to commercialize the red blood cell system. In addition, existing lots of these red blood cell compounds
manufactured under cGMP may be dispositioned by regulators or ourselves as unsuitable for either commercial or clinical use which
would impact our ability to produce INTERCEPT-treated red blood cells for ongoing and future clinical trials and may require
changes to the manufacturing process of our red blood cell compounds or new production of the compounds, all of which would be
costly and time consuming and impact our ability to perform under our contract with BARDA. We understand that one of our
component suppliers for our red blood cell system is in receivership and its assets have been put up for sale by the court. We have no
visibility and cannot control who the ultimate purchaser of the assets will be or whether such purchaser will be able to supply our
component to us on reasonable terms or at all. While we are in the process of identifying alternate manufactures of our red blood cell
compounds, qualification of any alternate supplier will be time consuming and may cause delay in obtaining regulatory approval or
commercialization and will cause us to incur additional cost. In addition, our supplier in receivership was unable to maintain its
production facility in accordance with cGMP requirements. As a result, unless we are able to obtain the release of previously
manufactured components under the cGMP requirements, we may have delays in completing our clinical trials or delays in supplying
product for commercial use. Further, we are currently in the process of negotiating a commercial supply agreement with the
manufacturer of the processing kits used in the red blood cell clinical trials. If we are unable to reach agreement on terms, our ability
to complete the RedeS and ReCePI studies and any future Phase 3 clinical trials may be adversely impacted. There can be no
guarantee that we will reach agreement or that, if an agreement is reached, that it will be on terms favorable to us.
In 2003, we terminated Phase 3 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 1 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
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and commenced two Phase 3 clinical trials in Europe using the modified process in patients with acute and chronic anemia,
respectively. We successfully completed the European Phase 3 acute anemia clinical trial and the European Phase 3 chronic anemia
clinical trial, with the INTERCEPT Blood System for red blood cells meeting its primary efficacy and safety endpoints in both trials.
However, we cannot assure you that the adverse events observed in the terminated 2003 Phase 3 clinical trials of our earlier red blood
cell system will not be observed in the future. In addition, although our completed European Phase 3 clinical trials in acute anemia
patients and chronic anemia patients using our modified process met their primary endpoints, we cannot assure you that the same or
similar results will be observed in current and potential future clinical trials using our modified process. We cannot assure that patients
receiving INTERCEPT-treated red blood cells will not develop allergic reactions to the transfusion.
We will need to successfully conduct and complete each of the RedeS and ReCePI studies as well as an additional Phase 3 clinical
trial for chronic anemia patients, including sickle-cell anemia patients, in the U.S. before the FDA will consider our red blood cell
system for approval. Given the need to phenotypically match donations and patients and the existing burden of managing the
production and supply to sickle-cell anemia patients, donor recruitment in a potential additional Phase 3 clinical trial may be difficult
or impractical, which could significantly delay or preclude our ability to obtain any FDA approval of our red blood cell system. In any
event, there can be no assurance that we will be able to successfully complete these perquisite Phase 3 clinical trials or otherwise
generate sufficient Phase 3 clinical data, 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 an additional Phase 3 clinical trial. In part, we will seek to introduce
supplemental clinical data we obtained from European clinical trials, though we cannot assure you that we will be able to demonstrate
comparability or that the FDA will allow supplemental clinical European data. The FDA will require us to place a clinical hold on any
clinical trial if we see a hemolytic reaction associated with treatment 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 may force us 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. Moreover, we do not currently have an approved protocol to investigate any antibody
formation from S-303-treated red blood cells, should one occur. Our ability to successfully investigate the underlying cause of any
detected anti-body, assess clinical significance and imputability will depend on having such a protocol in place prior to occurrence of
such an event. Our clinical trials, RedeS and ReCePI, each allow for events where antibodies to amustaline (S-303) are detected in the
absence of clinical hemolysis. Should we see three or more events where antibodies to amustaline (S-303) are formed without
evidence of hemolysis, or a single event with clinical hemolysis, then completion of the study will be delayed or permanently halted
until we can demonstrate that the antibodies were not clinically significant and the FDA and the Data and Safety Monitoring Board, or
DSMB, agree to continue the study. To date, a single S-303 antibody event without evidence of hemolysis has been detected in the
RedeS study. We do not yet know if the single S-303 antibody event was in the control or test arm, however the event is not clinically
significant. In addition, if we are unable to generate sufficient perquisite Phase 3 clinical data and/or reach agreement with the FDA on
a Phase 3 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.
We completed our European Phase 3 clinical trials of our red blood cell system for acute anemia patients and separately for chronic
anemia patients. We filed our application for CE Mark approval of the red blood cell system in December 2018. We do not expect to
receive any regulatory approvals of our red blood cell system prior to 2020, if ever. We understand that while the data generated from
our European Phase 3 clinical trials may be sufficient to receive CE Mark approval, we may need to generate additional safety data
from commercial use in order to achieve broad market acceptance. In addition, the European Phase 3 clinical trials in acute, and
separately, chronic anemia patients, may need to be supplemented by additional, successful Phase 3 clinical trials for approval in
certain countries. If such additional Phase 3 clinical trials are required, they would likely need to demonstrate equivalency of
INTERCEPT-treated red blood cells compared to conventional, un-treated red blood cells and the significantly lower lifespan for
INTERCEPT-treated red blood cells compared to conventional, un-treated red blood cells may limit our ability to obtain any
regulatory approvals in certain countries for the red blood cell system. 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. Further, while 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, if we are unable to generate sufficient product revenue, or access sufficient funds under our BARDA
agreement or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan.
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
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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. Additionally, the use of the red
blood cell system may result in some processing loss of red blood cells. If the loss of red blood cells leads to increased costs, or the
perception of increased costs for potential customers, or potential customers believe that the loss of red blood cells reduces the
efficacy of the transfusion unit, or our process requires changes in blood center or clinical regimens, potential customers may not
adopt our red blood cell system even if approved for commercial sale.
Platelet and Plasma Systems
In 2007, we obtained a CE Mark approval from E.U. regulators for our platelet system, and have subsequently received a renewal in
2012 and again in 2017, in accordance with the five-year renewal schedule. We or our customers have received approval for the sale
and/or use of INTERCEPT-treated platelets within 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 from E.U. regulators for our plasma system, and have subsequently received a renewal in
2011 and again in 2016, 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, Germany and Austria. 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.
The FDA has approved the platelet system for ex vivo preparation of pathogen-reduced apheresis platelet components collected and
stored in InterSol and 100% plasma in order to reduce the risk of transfusion-transmitted infection, or TTI, including sepsis, and as an
alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease, or TA-GVHD. Additionally, the
FDA approved the plasma system for ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to
reduce the risk of TTI when treating patients requiring therapeutic plasma transfusion and as an alternative to gamma irradiation for
prevention of TA-GVHD. 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
complete the study in a timeframe acceptable to the FDA. Furthermore, blood centers’ ability to produce INTERCEPT-treated
platelets and supply hospitals enrolled in the study may be negatively impacted by a shortage of overall platelet availability,
constraints in producing platelets in compliance with our approved claims or operational inefficiencies experienced as a result of
INTERCEPT treatment. 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 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
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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 the RedeS and ReCePI studies and planned or required clinical trials or 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, individual imprisonment, additional reporting obligations and oversight
if we become subject to a corporate integrity agreement or other agreement to resolve allocations of non-compliance with these laws,
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, and diminished profits and future earnings. 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.
Regulatory authorities may also challenge the classification of our approvals for our products. For instance, we understand that the Dutch
Competent Health Authority has questioned whether or not our products should be regulated as a drug instead of a medical device. While
we and our notified body are confident in the current classification, we cannot assure you that regulators will conclude that our products
should continue to be regulated as a medical device. Should we have to comply with drug regulations, we will incur additional costs, may
need to generate additional data from studies to maintain approval and may be unable to comply timely, if ever.
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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adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties;
repair, replacement, recall or seizure of our products;
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;
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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 product 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 product 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.
Should we obtain approval of our red blood cell system, we will likely be required by regulators to collect additional data in patients
receiving INTERCEPT-treated red blood cells. In addition, we may be required to develop a registry of patients receiving
INTERCEPT-treated red blood cells for future data collection and evaluation. Should we become subject to such a requirement post-
approval, we may incur significant costs to develop, create and implement such a registry. Further, introducing and implementing use
of such a registry may face data collection challenges or resistance from transfusing physicians, hospitals or patients. We cannot
ensure that the data collected in such a registry would support continued use of INTERCEPT-treated red blood cells.
In addition, the regulations to which we are subject are complex and have become more stringent over time. Regulatory changes could
result in restrictions on our ability to carry on or expand our operations, increased operation costs or lower than anticipated sales. For
instance, we understand that we will have to re-register our CE Marked products under the new Medical Device Regulations, or MDR,
(as required by all manufacturers who sell in Europe under a CE Mark), while we anticipate this will be a formality, there is always a
possibility of new requirements.
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. The agreement, including its subsequent modifications, provide for reimbursement of certain expenses incurred by us
for up to approximately $201.2 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 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 approximately $103.2 million under the base period of the agreement and options exercised. Accordingly, our ability to
receive any of the additional $98.0 million in funding provided for under the BARDA agreement is dependent on BARDA exercising
additional 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
reimbursement of amounts currently incurred and obligated by us as a result of contract performance. 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.
For instance, our RedeS study, which is being funded as part of our agreement with BARDA, is currently being conducted in Puerto
Rico and Florida. Given the hurricanes and destruction to both Puerto Rico and Florida in recent years, our ability to enroll patients
and make meaningful progress with the RedeS study has been and may continue to be negatively impacted and the successful
completion of the RedeS study will likely depend on increasing enrollment through sites outside of Puerto Rico, Florida and Texas.
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
agreement. If we are unable to provide adequate supplier oversight or if suppliers are unable to comply with the requirements of the
agreement, 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
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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
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 our business, 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.
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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;
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 have entered into and will continue to 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.
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If we or our third-party suppliers fail to comply with the FDA’s or other regulatory agency’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
time-consuming and would negatively impact our ability to generate product revenue from the sale of our platelet or plasma system in
the U.S. and achieve operating profitability. Our red blood cell system also needs to be manufactured in FDA-approved facilities,
several of which, are not currently FDA-approved. Failure of our suppliers to meet cGMP regulations and failure to obtain or maintain
FDA approval will negatively impact our ability to achieve FDA approval for our red blood cell system or may require that we
identify, qualify and contract with alternative suppliers, if they are available, which would be time consuming, costly and result in
further approval delays.
We and our third-party suppliers are also required to comply with the 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 and other regulatory agencies audit compliance with cGMP and QSR requirements through periodic
announced and unannounced inspections of manufacturing and other facilities. These audits and inspections may be conducted 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 or other regulatory agency 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 this regard, one of our
component suppliers for our red blood cell system has been unable to maintain its production facility in accordance with cGMP
requirements. As a result, unless we are able to obtain the release of previously manufactured components under the cGMP
requirements, we may have delays in completing our clinical trials or delays in supplying product for commercial use. 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 premarket approval application, or 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 submissions 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 or will have to
redesign the illuminators used in the platelet and plasma systems and we will need to receive approval of these changes from the FDA.
Further, certain plastics used to make INTERCEPT disposable kits are no longer available. We have received CE Mark and FDA
approval for our platelet product using the alternate plastics, but will need to qualify, validate and obtain approval for those plastics for
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our plasma product in any other jurisdictions that require local regulatory approval before we can utilize them in worldwide
commercial manufacturing. 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 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 may conduct 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 product 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 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 may
seek to expand use of our products under new PMA approvals or PMA supplements. For instance, we plan to perform in vitro studies
and seek a PMA supplement to use our plasma system to produce extended storage cryoprecipitate and possibly for other plasma-
derived biological plasma products. Such products may require or we may choose to pursue a change in business model whereby we
are selling the finished component to hospitals rather than an illuminator and disposable kit to blood centers. While we are working on
implementing the infrastructure we believe will be necessary to market an approved extended-storage cryoprecipitate product directly
to hospitals subsequent to potential regulatory approval of any PMA supplement that we may propose to submit to the FDA, we have
no experience selling to hospitals nor do we have experience or expertise complying with regulations governing finished biologics. If
we are unable to successfully market such products to hospitals or comply with unique regulations, our ability to monetize and deliver
such products will be negatively impacted.
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’ and other customers’
demands, which could result in a loss of product 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, 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 product revenue that we recognize from such a territory,
which would adversely affect our results of operations and could adversely affect our financial condition. Furthermore, we may
choose to seek alternative ways to sell or treat blood components with our products. These may include new business models, which
may include selling kits to blood centers, performing inactivation ourselves, staffing blood centers or selling services or other business
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model changes. We have no experience with these types of business models, or the regulatory requirements or licenses needed to
pursue such new business models. Additionally, such business models may be viewed as a threat to existing customers. We cannot
assure you that we will pursue such business models or if we do, that we will be successful or that our existing customers will not feel
threatened.
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,”
and the U.K. government delivered a notice of withdrawal in March 2017, with the U.K. scheduled to exit the E.U. by April 2019. The
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 a 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 product 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 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 product 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 may 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 revenue will be adversely impacted with the loss or transition of one or more of these distributors. If we choose to terminate
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 or that the distributor will honor its outstanding commitments to us. 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, public tenders, or regulatory certificates or licenses held in
their name. 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
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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 product 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. Successfully commercializing our products in the U.S. may take considerable time
during which we will need to build relationships, additional routine-use data and trust from the industry. As a company, we have no
prior experience in commercializing any products in the U.S., and we still need to attract, retain, train and support sales, marketing and
scientific and hospital affairs personnel and other commercial talent. For example, we need to attract and retain hospital affairs
professionals to help educate hospitals and physicians on our products, clinical trial history and publications. Hospital affairs
professionals are highly educated and trained professionals and the hiring and employment market for hospital affairs professionals is
highly competitive. As such, we need to commit significant additional management and other resources in order to maintain and
expand our hospital affairs team and sales and marketing functions. We may be unable to develop and maintain adequate hospital
affairs, 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 hospital affairs, sales and marketing personnel that we
anticipate we need. 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
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. In addition, should we seek and obtain approval for unique biological
products created by use of the INTERCEPT blood system, including extended storage cryoprecipitate, we may choose to sell the
treated end product directly to hospitals using our commercial organization. While we are working on implementing the infrastructure
we believe will be necessary to market an approved extended-storage cryoprecipitate product directly to hospitals subsequent to
potential regulatory approval of any PMA supplement that we may propose to submit to the FDA, we have no experience selling
biological end products directly to hospitals which may cause a distraction for our commercial organization or we may be viewed as a
competitive threat to our blood center customers.
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
gross margins will be negatively impacted.
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. In the event Fresenius refuses or is unable to continue operating
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under the 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 automatically extended at the end of 2017 and now continues until
December 31, 2019, and will continue to automatically renew 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. We have not been notified by Ash Stevens of
their intention to terminate the agreement. 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.
In April 2017, we entered into an amended and restated manufacturing and supply agreement with Porex for the continued supply of
the compound adsorption devices. Porex is our sole supplier for certain components of and manufacturing of the compound adsorption
devices. Under the amended and restated Porex agreement, we are no longer subject to a minimum annual purchase requirement;
however, Porex has the right to terminate the agreement, upon twelve months’ prior written notice, if annual production falls below a
mutually agreed threshold. If not sooner terminated, the amended and restated Porex agreement expires on December 31, 2019. In
addition, we entered into an amended and restated supply agreement with Brotech Corporation d/b/a Purolite Company, or Purolite,
for the supply of raw materials used to make the compound adsorption devices. 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 2019 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. In addition, given our recent rapid growth and potential for continued or even accelerated growth,
we may need to identify, validate and qualify additional manufacturing capacity with existing or new suppliers. Further, customer
demand for our platelet kits may fully utilize the production capacity of our third party manufacturer, as a result we may need to
allocate manufacturing resources such that our supply of platelet kits or plasma kits could be adversely impacted. Even a temporary
failure to supply adequate numbers of INTERCEPT Blood System components may cause an irreparable loss of customer goodwill
and potentially irreversible loss of momentum in the marketplace. Although we are actively evaluating alternate suppliers for certain
components, we do not have qualified suppliers or capacity 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 from whom our contract
manufacturers source components and raw materials may cease production or supply of those components to our contract
manufacturers. For example, certain plastics used to make INTERCEPT disposable kits are no longer available. As a result, we and
our manufacturers have identified alternate plastics and we have received CE Mark and FDA approval for our platelet product using
the alternate plastics, but will need to qualify, validate and obtain approval for those plastics for our plasma product before we can
utilize them in worldwide commercial manufacturing. In addition, we understand that a compound adsorbent housing component is no
longer available and an alternate housing will need to be qualified by Fresenius. Identification and qualification of alternate suppliers
is time consuming and costly, and there can be no assurance that we will be able to demonstrate equivalency of alternate components
or suppliers or that we will receive regulatory approval in the U.S. or other jurisdictions. If we conclude that supply of the
INTERCEPT Blood System or components from suppliers 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, increase production for existing customers or sign up new customers may be negatively impacted. Due to the
obsolescence of certain parts, we have redesigned or will have to redesign the illuminators used in the platelet and plasma systems,
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and we will need to receive approval of these changes 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 product revenue 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. Furthermore, we understand that components used in the
redesigned illuminator are no longer commercially available beyond what we and Nova have stockpiled or to which we have access
under final buy transactions or may become unavailable in the current specifications in the near-term. As with our disposable sets, if
we conclude that supply of components or spare parts for the illuminators is uncertain, we may choose to purchase and maintain
inventories of such components or spare parts, which would consume capital resources faster than we anticipate and may cause our
supply chain to be less efficient. We will need to continue investing in subsequent versions of the illuminator to enhance functionality
and manage obsolescence. 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,
non-conformities 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 clinical use, commercial
sale and regulatory submissions. Non-conformities can increase our expenses and reduce gross margins or result in delayed regulatory
submissions or clinical trials. Should non-conformities occur in the future, we may be unable to manufacture products to support our
read blood cell clinical trials, or to meet customer demand for our commercial products, which would result in delays for our clinical
programs, or lost sales for our commercial products, 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. For example, in April 2018, we instituted a voluntary recall in the E.U. of a specified
lot of our disposable platelet kits after identifying the possibility of an incomplete seal where the tubing meets the base of the sampling
pouch, which is used to obtain a sample of the INTERCEPT –treated platelets. We may voluntarily recall additional lots of disposable
kits if this incomplete seal is identified in other lots. This voluntary recall may have a material adverse effect on the customers
impacted and potentially impacted by the recall, as well as our relationship with such customers. In addition, in September 2018, we
instituted a voluntary recall in the U.S. of a specified lot after we identified the possibility that an incorrect sized bag may have been
used in the manufacture of INTERCEPT platelet kits. While we do not believe this recall affected patient safety in any way, our
reputation with customers may be negatively impacted and regulators may require additional measures to ensure quality controls are
adequate.
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
customers, or may not accurately forecast demand ourselves for the INTERCEPT Blood System. Should actual demand for our
products exceed our own forecasts or forecasts that customers provide, we may be unable to fulfill such orders timely, if at all. Should
we be unable to fulfill demand, particularly if mandated by a public health authority, our reputation and business prospects may be
impaired. Further, certain distributors and customers require, and potential future distributors or customers may require, product with a
minimum shelf life. 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 choose 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. In order to meet minimum shelf-life requirements, we may need to manufacture
sufficient product to meet estimated 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. Our platelet and plasma systems’ disposable kits have 18 to 24 months shelf lives from the date of manufacture. Should we
change or modify any of our product configurations or components, such future configurations of our products may not achieve the
same shelf life that existing products have. 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.
We have entered into certain public tenders, some of 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
penalty fees, permanent harm to our customer relations or loss of customers. In addition, certain large national customers, like those in
France or the U.K. may choose to convert all of their operation to INTERCEPT. Should we or our suppliers encounter any
manufacturing issues, we may not be able to satisfy all of the global demand or may have to allocate available product to certain
customers which may negatively impact our customers operations and consequently, our reputation. 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. Additionally, should we conclude that existing
suppliers are not able to produce sufficient quantities to meet the demand for our products, we may choose to invest in manufacturing
capacity at existing or new facilities with existing or new suppliers, which could be costly and disruptive to our management.
Certain regions that we sell into or may sell into in the future may give priority to those products that are manufactured locally in their
jurisdiction. Our failure to meet these local manufacturing conditions may prevent us from successfully commercializing our product
in those geographies. In addition, should we choose to manufacture locally in those jurisdictions, we would likely incur additional
costs, may be unable to meet our quality system requirements or successfully manufacture products, and such activities will be a
distraction from our current focus and operations. We have no experience manufacturing or working with manufacturers outside of
our current manufacturing footprint.
Obsolescence or shortage of raw materials, key components of and accessories to the INTERCEPT Blood System, may impact our
ability to supply our customers, may negatively impact the 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.
With respect to the manufacture of our products, our third party manufacturers source components and raw materials for the
manufacture of the INTERCEPT processing sets. Certain of these components are no longer commercially available, are nearing end-
of-life or are available only from a limited number of suppliers. We and our third party manufacturers do not have guaranteed supply
contracts with all of the raw material or component suppliers for our products, which magnify the risk of shortage and obsolescence
and decreases our manufacturers’ ability to negotiate pricing with their suppliers. For example, a solvent used in the manufacture of a
raw material for our compound adsorption device is no longer available. Our contract manufacturer has produced a substantial amount
of the raw material using its remaining inventory of the solvent as a last time purchase. However, the amount of material is finite and
we and our contract manufacturer will need to qualify an alternate solvent used in the manufacture of the raw material. Should the
material that we have available be defective or be otherwise unusable in any way, we and our contract manufacturer may have
insufficient time to qualify an alternate solvent before running out of existing material. Any shortage or obsolescence of raw materials,
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components or accessories or our inability to control costs associated with raw materials, components or accessories, 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
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, state and local 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 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, including the federal False Claims Act, 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 transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that
require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available
under Medicare, Medicaid, or the Children's Health Insurance Program, with specific exceptions, to track and annually
report to the Centers for Medicare & Medicaid Services, or CMS, payments and other transfers of value provided to
physicians and teaching hospitals, and certain ownership and investment interests held by physicians or their immediate
family members;
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the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; and
foreign, or U.S. state or local 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 and local 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. Moreover, effective May 25, 2018, the collection and use of
personal health data in the E.U. is governed by the provisions of the E.U. General Data Protection Regulation, or the GDPR. The
GDPR, which is wide-ranging in scope, imposes several requirements relating to the control over personal data by individuals to
whom the personal data relates, the information provided to the individuals, the documentation we must maintain, the security and
confidentiality of the personal data, data breach notification and the use of third party processors in connection with the processing of
personal data. The GDPR also imposes strict rules on the transfer of personal data out of the E.U., provides an enforcement authority
and authorizes the imposition of large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the
annual global revenues of the non-compliant company, whichever is greater. The GDPR requirements apply not only to third-party
transactions, but also to transfers of information between us and our subsidiary, including employee information. The GDPR has
increased our responsibility and potential liability in relation to personal data that we process compared to prior E.U. law, including in
clinical trials, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, which could divert
management’s attention and increase our cost of doing business. However, despite our ongoing efforts to bring our practices into
compliance with the GDPR, we may not be successful either due to various factors within our control or other factors outside our
control. It is also possible that local data protection authorities may have different interpretations of the GDPR, leading to potential
inconsistencies amongst various E.U. member states. Any failure or alleged failure (including as a result of deficiencies in our
policies, procedures or measures relating to privacy, data security, marketing or communications) by us to comply with laws,
regulations, policies, legal or contractual obligations, industry standards or regulatory guidance relating to privacy or data security,
may result in governmental investigations and enforcement actions, litigation, fines and penalties or adverse publicity. In addition,
new regulation, legislative actions or changes in interpretation of existing laws or regulations regarding data privacy and security
(together with applicable industry standards) may increase our costs of doing business. In this regard, we expect that there will
continue to be new laws, regulations and industry standards relating to privacy and data protection in the United States, the E.U. and
other jurisdictions, such as the California Consumer Privacy Act of 2018 that will go into effect beginning January 1, 2020, which has
been characterized as the first “GDPR-like” privacy statute to be enacted in the U.S. because it mirrors a number of the key provisions
in the GDPR, and we cannot determine the impact such new laws, regulations and standards may have on our business.
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 United States Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation
Act, or collectively, 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.
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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, state and local regulation of payments and transfers of value
provided to healthcare professionals or entities. Section 6002 of the ACA, known as the Physician Payments Sunshine Act, imposes
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 significant civil monetary penalties. Manufacturers must submit reports to
CMS by the 90th day of each subsequent calendar year. Due to the difficulty in complying with the Physician Payments 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 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.
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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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imposed an annual excise tax of 2.3% on entities that manufacture or import eligible medical devices offered for sale in
the U.S.;
established a Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical
effectiveness research in an effort to coordinate and develop such research; and
implemented 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.
Since its enactment, there have been judicial and Congressional challenges to numerous provisions of the ACA, as well as recent
efforts by the Trump administration to repeal or replace certain aspects of the ACA. Since January 2017, President Trump has signed
two Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA or otherwise
circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislation
that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two
bills affecting the implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017, or
the Tax Act, includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the
ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the
“individual mandate”. On January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018
that delayed the implementation of certain ACA-mandated fees, including delaying imposition of the medical device excise tax on
non-exempt medical devices through December 31, 2019. In July 2018, CMS published a final rule permitting further collections and
payments to and from certain ACA-qualified health plans and health insurance issuers under the ACA risk adjustment program in
response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment. On
December 14, 2018, a Texas U.S. District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual
mandate” was repealed by Congress as part of the Tax Act. While the Texas U.S. District Court Judge, as well as the Trump
administration and CMS, have stated that the ruling will have no immediate effect pending appeal of the decision, it is unclear how
this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the ACA and our business. Any repeal
and replace legislation may have the effect of limiting the amounts that government agencies 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.
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, due to subsequent legislative amendments to the statute, including the Bipartisan Budget Act of 2018, will stay in
effect through 2027, 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. More recently, there has been heightened governmental scrutiny in the United States to control the rising cost of healthcare. For
example, such scrutiny has resulted in several recent congressional inquiries and federal and state legislative activity designed to,
among other things, bring more transparency to pricing and reform government program reimbursement methodologies for
pharmaceutical products, some of which are included in the Trump administration’s “Blueprint to Lower Drug Prices and Reduce Out-
of-Pocket Costs” released in May 2018. State legislatures are also increasingly passing legislation and implementing regulations
designed to control the cost of healthcare, including price or patient reimbursement constraints, discounts, restrictions on certain
product access and marketing cost disclosure and transparency measures.
The Trump administration has publicly stated a core goal is to deregulate wherever possible. It is unclear if this contraction in
regulation would also apply to previously issued 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
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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. Further, blood centers using INTERCEPT must have access to those certain devices, blood bags, assays
or platelet additive solutions that are compatible with our products.
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 PASs. Many of our customers and
prospective customers use InterSol or SSP+ in connection with INTERCEPT treatment. Similarly, some of our customers combine
multiple platelet or plasma components before treating the combined product with INTERCEPT. There are several third party
manufacturers of pooling sets to allow for such combination. Our customers’ ability to use our INTERCEPT products may be
impaired should manufacturers of those products not provide access to their products allowing for the combination of multiple
components or if such manufacturers experience a shortage of their products. Should manufacturers of collection devices, compatible
assays and blood bags, pooling sets or platelet additive solutions fail to obtain or maintain regulatory approval, experience unexpected
production disruption, or decide to cease distribution of those respective products to customers and prospective customers, our ability
to sell the INTERCEPT Blood System may be impaired and acceptance in the marketplace could be harmed.
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 may conduct 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 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 product revenue 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 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 product revenue and potential future profitability.
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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 product 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 3
clinical trial underway in Germany to generate additional data for expanded approvals. 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 BCT’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 BCT’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.
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.
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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,
malfunctions, manufacturing errors, design or labeling defects or other deficiencies and issues. For example, in April 2018, we
instituted a voluntary recall in the E.U. of a specified lot of our disposable platelet kits after identifying the possibility of an
incomplete seal where the tubing meets the base of the sampling pouch, which is used to obtain a sample of the INTERCEPT –treated
platelets. In addition, in September 2018, we instituted a voluntary recall in the U.S. of a specified lot after we identified the
possibility that an incorrect sized bag may have been used in the manufacture of INTERCEPT platelet kits. 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.
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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, 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., 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. While 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, if we are unable to generate sufficient product revenue, or access
sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute
successfully on our operating plan. 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 amended and restated loan and security agreement, or the Amended Credit 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, financial performance covenants 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.
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 and our ability to achieve the required milestones under the agreement. 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
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significant negative impact on our revenues and cash flows. In addition, if we are unable to generate sufficient perquisite Phase 3
clinical data and/or reach agreement with the FDA on an additional Phase 3 clinical trial for chronic anemia in the U.S. 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 if additional studies are necessary for regulatory approval in Europe,
which would increase our costs and potentially delay the approval. 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 additional portions 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 Amended Credit 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 Amended Credit Agreement.
As of December 31, 2018, our total indebtedness under our Amended Credit Agreement was approximately $29.9 million. 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 Amended Credit Agreement. The Amended Credit 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. In addition, receipt of a qualified audit opinion (other than as to going concern or a qualification resulting solely from
the scheduled maturity of term loans occurring within one year from the date such opinion is delivered) would be a violation of an
affirmative covenant under the Amended Credit Agreement. While 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, if we are unable to generate sufficient product revenue, or access sufficient
funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute
successfully on our operating plan. Our failure to comply with any of the covenants could result in a default under the Amended
Credit 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 Amended Credit Agreement. If we are unable to repay those amounts,
the lenders under the Amended Credit 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.
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
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.
We recently signed a lease for a new corporate headquarters and laboratories and plan to move all of our research and development
personnel and most of our selling general and administrative personnel in the United States to this new location. A move of this
magnitude and complexity will be expensive and may be disruptive to our operations. For example, all of our laboratory equipment
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will need to be moved, many requiring calibration and validation prior to being ready for use in ongoing and new studies. Delays or
problems resulting from the move may cause a delay in our ability to commence or complete these studies.
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. As use of
information technology systems has increased, deliberate attacks and attempts to gain unauthorized access to computer systems and
networks have increased in frequency and sophistication. Our information technology, systems and networks 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. We are also potentially vulnerable to data security breaches—whether by employees
or others—which may expose sensitive data to unauthorized persons. For example, we have in the past and may in the future be
subject to “phishing” attacks in which third parties send emails purporting to be from reputable sources. Phishing attacks may attempt
to obtain personal information, infiltrate our systems to initiate wire transfers or otherwise obtain proprietary or confidential
information. Although we have not experienced any losses as a result of such attacks or any other breaches of data security, such
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.
Breaches and other inappropriate access can be difficult to detect and any delay in identifying them could increase their harm. While
we have implemented security measures to protect our data security and information technology systems, such measures may not
prevent such events. Any such breaches of security and inappropriate access could disrupt our operations, harm our reputation or
otherwise have a material adverse effect on our business, financial condition and results of operations.
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.
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. On December 22, 2017, President Trump signed into law the Tax Act. Under the Tax Act, federal net
operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net
operating losses is limited. It is uncertain if and to what extent various states will conform to the Tax Act. 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,
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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 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
recently expired 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 have infringed
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 have infringed any valid claim of this patent, we may, among other things, be required to pay damages. Our patents
expire at various dates between 2019 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 2019 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 product 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
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
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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, as well as to 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. Should this foreign exchange volatility continue or increase, 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
product 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 recently imposed tariffs on
certain U.S. imports. Canada, the E.U., China and other countries have responded with retaliatory tariffs on certain U.S. exports. We
also rely on various U.S. corporate tax provisions related to international commerce. If we are subject to new regulations, including
those under the Tax Act, 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.
If the London Inter-Bank Offered Rate, or LIBOR, is discontinued, interest payments under our Amended Credit Agreement may
be calculated using another reference rate.
In July 2017, the Chief Executive of the United Kingdom Financial Conduct Authority, or FCA, which regulates LIBOR, announced
that the FCA intends to phase out the use of LIBOR by the end of 2021. In addition, the U.S. Federal Reserve, in conjunction with the
Alternative Reference Rates Committee, a steering committee comprised of large U.S. financial institutions, is considering replacing
U.S. dollar LIBOR with the Secured Overnight Financing Rate, or SOFR, a new index calculated by short-term repurchase
agreements, backed by Treasury securities. Although there have been certain issuances utilizing SOFR, it is unknown whether this or
any other alternative reference rate will attain market acceptance as a replacement for LIBOR. U.S. dollar LIBOR is used as a
benchmark rate in our credit agreement with Oxford Finance LLC, and such credit agreement does not provide fallback language for
all circumstances in which U.S. dollar LIBOR ceases to be published. There remains uncertainty regarding the future utilization of
LIBOR and the nature of any replacement rate, and any potential effects of the transition away from LIBOR on us are not known. The
transition process may involve, among other things, increased volatility and illiquidity in markets for instruments that currently rely on
LIBOR and may result in increased borrowing costs, the effectiveness of related transactions such as hedges, uncertainty under
applicable documentation, including our credit agreement with Oxford Finance LLC, or difficult and costly processes to amend such
documentation. As a result, our ability to refinance our Amended Credit Agreement or other indebtedness or to hedge our exposure to
floating rate instruments may be impaired, which would adversely affect the operations of our business.
49
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
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.
50
The Tax Act could adversely affect our business and financial condition.
The Tax Act significantly changes the Internal Revenue Code of 1986, as amended. The Tax Act, among other things, contains
significant changes to corporate taxation, including reduction of the corporate tax rate on future earnings to 21%, limitation of the
future tax deduction for net interest expense, limitation of the deduction for future net operating losses to 80% of current year taxable
income and elimination of net operating loss carrybacks, changes in the treatment of offshore earnings regardless of whether they are
repatriated, mandatory capitalization of research and development expenses, further deduction limits on executive compensation and
modifying, repealing and creating many other business deductions and credits. Our federal net operating loss carryovers generated in
2018 and thereafter will be carried forward indefinitely pursuant to the Tax Act. We continue to examine the impact this tax reform
legislation may have on our business. In addition, it is uncertain if and to what extent various states will conform to the Tax Act. The
impact of the Tax Act on holders of our common stock is also uncertain and could be adverse. We urge our stockholders to consult
with their legal and tax advisors with respect to such legislation and the potential tax consequences of investing in our common stock.
Item 1B. Unresolved Staff Comments
None.
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 and future 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, 2018.
Locations
Concord, CA, United States...........
Concord, CA, United States...........
Concord, CA, United States...........
Concord, CA, United States...........
Concord, CA, United States (1).......
Amersfoort, Netherlands................
Square
Footage
Lease Expiration
Date
Primary Functions
Administrative and research
36,029 November 2019
7,702 September 2019 Administrative and warehouse
6,655 December 2019
21,440 July 2019
84,631 March 2030
7,300 January 2023
Administrative and research
Sales, administrative, marketing and technical support
Administrative and research
Sales and administrative
(1) In February 2018, we entered into a lease arrangement and certain subsequent amendments for a new corporate headquarters in Concord, California. The lease
term commences on March 1, 2019.
Item 3.
Legal Proceedings
None.
Item 4.
Mine Safety Disclosures
Not applicable.
51
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”.
On February 15, 2019, the last reported sale price of our common stock on the Nasdaq Global Market was $6.47 per share. On
February 15, 2019, we had 138 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
amended and restated loan and security agreement entered on July 31, 2017, with Oxford Finance LLC.
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, 2013, and tracked the performance through December 31, 2018, for (i) our common stock, (ii) the Nasdaq
Biotechnology Index, and (iii) 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
200
100
0
2013
2014
2015
2016
2017
201800101
Cerus
Nasdaq Biotech Index
Nasdaq
Cerus Corporation ....................... $
Nasdaq Biotech Index..................
Nasdaq .........................................
100.00 $
100.00
100.00
96.74 $
134.10
113.40
97.98 $
149.42
119.89
67.44 $
117.02
128.89
52.40 $
141.66
165.29
78.60
128.45
158.87
2013
2014
2015
2016
2017
2018
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.
52
Item 6.
Selected Financial Data
The following table summarizes certain selected financial data for the five years ended December 31, 2018, 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:
Product revenue...................................................................... $
Cost of product revenue .........................................................
Gross profit on product revenue .......................................
Government contract revenue ................................................
Loss from operations ..............................................................
Net loss...................................................................................
2018
Year Ended December 31,
2016
2015
2017
60,908 $
31,634
29,274
15,143
(54,988)
(57,564)
43,568 $
22,531
21,037
7,758
(57,530)
(60,585)
37,183 $
20,295
16,888
2,092
(61,447)
(62,906)
34,223 $
23,464
10,759
—
(61,075)
(55,868)
2014
36,416
21,118
15,298
—
(44,503)
(38,755)
Net loss per share:
Basic.................................................................................. $
Diluted .............................................................................. $
(0.44) $
(0.44) $
(0.56) $
(0.56) $
(0.62) $
(0.62) $
(0.58) $
(0.61) $
(0.52)
(0.61)
Weighted average shares outstanding used for calculating
loss per share:
Basic..................................................................................
Diluted ..............................................................................
131,663
131,663
108,221
108,221
101,826
101,826
96,068
96,905
74,767
76,534
(in thousands)
Consolidated Balance Sheets Data:
Cash, cash equivalents and short-term investments ............... $
Working capital ......................................................................
Total assets .............................................................................
Long-term obligations ............................................................
Total stockholders' equity.......................................................
2018
2017
December 31,
2016
2015
2014
117,577 $
94,224
163,460
26,263
84,519
60,696 $
66,767
98,244
36,173
38,940
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
53
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, 2018. Operating results for the year
ended December 31, 2018 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 U.S. Food and Drug Administration, or FDA,
approval and are being marketed and sold in a number of countries around the world. We sell both the platelet and plasma systems
using our direct sales force and through distributors.
The platelet system is approved in the U.S. for ex vivo preparation of pathogen-reduced apheresis platelet components collected and
stored in 100% plasma or InterSol in order to reduce the risk of transfusion-transmitted infection, or TTI, including sepsis, and as an
alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease or TA-GVHD. As part of the FDA’s
approval of the platelet system, we are required to successfully conduct and complete two post-approval studies - a haemovigilance
study to evaluate the incidence of acute lung injury following transfusion of INTERCEPT-treated platelets; and a recovery study of
platelets treated with the platelet system that is currently being discussed with FDA. The plasma system is approved in the U.S. for ex
vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of TTI when treating
patients requiring therapeutic plasma transfusion, and as an alternative to gamma irradiation for prevention of TA-GVHD.
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 announced the successful completion of our European Phase 3 clinical trial of our red
blood cell system for acute anemia patients in January 2015, and in January 2018, we reported that the primary efficacy and safety
endpoints were successfully achieved in our European Phase 3 clinical trial for chronic anemia patients. Based on the results of those
trials, we filed for CE Mark approval in the European Union in December 2018. In the U.S., we successfully completed a Phase 2
recovery and lifespan study in 2014. In 2017, we initiated a Phase 3 clinical, double-blind study, known as the RedeS study, to assess
the safety and efficacy of INTERCEPT-treated red blood cells when compared to conventional, un-treated, red blood cells in regions
impacted by the Zika virus epidemic. Also in 2017, we received investigational device exemption, or IDE, approval from the FDA to
initiate a Phase 3 clinical trial, known as the ReCePI study that is designed to evaluate the efficacy and safety of INTERCEPT-treated
red blood cells in patients requiring transfusion for acute blood loss during surgery. In addition to successfully conducting and
completing the RedeS and ReCePI studies, we will need to successfully conduct and complete an additional Phase 3 clinical trial for
chronic anemia patients, including sickle-cell anemia patients, in the U.S. before the FDA will consider our red blood cell system 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 additional Phase 3 clinical trial. There can be no assurance that we will be able to
successfully complete 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 additional Phase 3 clinical trial. In addition, given the
need to phenotypically match donations and patients and the existing burden of managing the production and supply to sickle-cell
anemia patients, donor recruitment in a potential additional Phase 3 clinical trial may be difficult or impractical, which could
significantly delay or preclude our ability to obtain any FDA approval of our red blood cell system. Although we plan to complete
additional development activities to support CE Mark submission for the red blood cell system, such activities could prolong the
development of our red blood cell system, and we do not expect to receive any regulatory approvals of our red blood cell system prior
to 2020, if ever. We must demonstrate an ability to define, test and meet acceptable specifications for our current Good Manufacturing
Practice manufactured compounds used to prepare INTERCEPT-treated red blood cells before we can submit and seek regulatory
approval of our red blood cell system. We understand that while the data generated from our European Phase 3 clinical trials may be
sufficient to receive CE Mark approval, we may need to generate additional safety data from commercial use in order to achieve broad
market acceptance. In addition, these trials may need to be supplemented by additional, successful Phase 3 clinical trials for approval
in certain countries. If such additional Phase 3 clinical trials are required, they would likely need to demonstrate equivalency of
INTERCEPT-treated red blood cells compared to conventional, un-treated red blood cells and the significantly lower lifespan for
INTERCEPT-treated red blood cells compared to conventional, un-treated red blood cells may limit our ability to obtain any
regulatory approvals in certain countries 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 certain additional
activities, including successfully completing the RedeS and ReCePI studies and an additional Phase 3 clinical trial for chronic anemia
patients, including sickle-cell anemia patients, 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 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. In addition, if we are unable to develop sufficient quantities of the active
54
compounds for our products meeting defined quality and regulatory specifications or if our suppliers are not able to maintain
regulatory compliance, we may experience delays in testing, conducting trials or obtaining approvals, and our product development
costs would likely 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 from BARDA 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. The RedeS and ReCePI studies are being funded as part of our agreement with BARDA. Under the contract,
BARDA reimburses us as allowable direct contract costs are incurred plus allowable indirect costs. See the discussion under
“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 continuing U.S. commercialization of
our platelet and plasma systems, 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., 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. While 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, if we are unable to generate sufficient product revenue, or access
sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute
successfully on our operating plan. 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 amended and restated loan and security agreement, or the Amended Credit 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, financial performance covenants 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.
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 any additional portions 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 U.S. commercial efforts for 2019 will
continue to be largely focused on implementing INTERCEPT at customers with whom we have previously signed agreements and
continuing to develop awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including
55
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. In addition, 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. We also plan to perform in vitro studies and seek a premarket approval, or PMA,
supplement to use our plasma system to produce extended-storage cryoprecipitate and possibly other plasma derived biological
products. We currently have agreements with certain blood center manufacturing partners and are actively working to identify
additional partners to manufacture the extended-storage cryoprecipitate. We are also working on implementing the infrastructure we
believe will be necessary to market an approved extended-storage cryoprecipitate product directly to hospitals subsequent to potential
regulatory approval of any PMA supplement that we may propose to submit to the FDA.
Outside of the U.S., 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. In July 2017, we entered
into new agreements with Établissement Français du Sang, or EFS, to supply illuminators and platelet and plasma disposable kits. We
understand that the EFS has adopted the platelet system across France, but cannot provide any assurance that national usage is
sustainable, since no purchase volume commitments have been made by EFS, in our current contract or otherwise. In addition,
significant product revenue from the French market may decline or not consistently occur quarter-over-quarter. We cannot assure that
the EFS will use the INTERCEPT Blood System for plasma at historical levels or at all. We also cannot provide any assurance that we
will be able to secure any subsequent contracts with EFS or that the terms, including the pricing or committed volumes, if any, of any
future contract will be equivalent or superior to the terms under our current contract.
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.
Fresenius
Fresenius Kabi AG, or Fresenius, manufactures and supplies the platelet and plasma systems to us under a supply agreement, or the
Supply Agreement. Fresenius is obligated to sell, and we are obligated to purchase, finished disposable kits for our platelet, plasma
and red blood cell systems. The Supply 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
The Supply Agreement requires us to make certain payments totaling €8.6 million, or the Manufacturing and Development Payments,
to Fresenius. In 2016, we paid €3.1 million to Fresenius. In August 2018, we entered into an amendment to the Supply Agreement,
accelerating the payment for the remaining €5.5 million to August 2019. Because these payments represent unconditional payment
obligations, we recognized our liability for these payments at their net present value using a discount rate of 9.72% based on our
effective borrowing rate at that time. The Manufacturing and Development Payments liability is accreted through interest expense
based on the estimated timing of its ultimate settlement. As of December 31, 2018, we had accrued $5.9 million (€5.2 million) related
to the Manufacturing and Development Payments.
The initial term of the Supply 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 Supply
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 Supply 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 our suppliers’ ability to source components and raw materials
56
which may at times be in short demand or obsolete. In such cases, we and/or Fresenius or other suppliers 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.
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 premarket approval application, 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 and its subsequent modifications provide for the reimbursement of certain amounts incurred by
us in connection with our satisfaction of certain contractual milestones. 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. BARDA has committed to
reimburse certain of our expenses related to the clinical development of the red blood cell system during a base period, or the Base
Period, and under exercised option periods, or Option Periods, in an aggregate amount of up to $103.2 million. If we satisfy
subsequent milestones and BARDA were to exercise additional Option Periods, the total funding opportunity under the BARDA
agreement could reach up to $201.2 million over the five-year agreement period. If exercised by BARDA in its sole discretion, each
subsequent Option Period 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 are currently
responsible for co-investment of approximately $5.0 million, and would be responsible for an additional $9.6 million, if certain
additional Option Periods are exercised by BARDA. 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 exercised Option Period.
BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate for convenience at any
time.
Although BARDA has committed to reimburse us for up to $103.2 million in expenses to date, we may not receive all of these funds if
BARDA were to terminate the agreement. Amounts invoiced and currently payable under the BARDA agreement are subject to future
audits at the discretion of the government. These audits could result in an adjustment to revenue previously reported, which potentially
could be significant.
Equity and Debt Agreements
Public Offering of Common Stock
In January 2018, we issued and sold 14,030,000 shares of our common stock, par value $0.001 per share, at $4.10 per share in an
underwritten public offering. The proceeds to us from this offering were approximately $57.2 million, net of the underwriting discount
and other issuance costs.
Cantor
On May 5, 2016, we entered into Amendment No. 2 to the Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald &
Co., or Cantor, that provided for the issuance and sale of shares of our common stock over the term of the Controlled Equity
OfferingSM Sales Agreement, or the Prior Cantor Agreement, having an aggregate offering price of up to $132.2 million, $70.0 million
of which was available at May 5, 2016, through Cantor.
On August 4, 2017, we entered into Amendment No. 3 to the Prior Cantor Agreement, or the Amended Cantor Agreement. The
Amended Cantor Agreement became effective on January 8, 2018, and provides for the issuance and sale of shares of our common
stock having an aggregate offering price of up to $70.0 million through Cantor, which amount includes the $31.4 million of unsold
shares of common stock available for sale under the Prior Cantor Agreement immediately prior to the effectiveness of the Amended
Cantor Agreement. Under the Amended Cantor Agreement, Cantor also 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 its common stock. During the year ended December 31,
2018, approximately 4.2 million shares of our common stock were sold under the Amended Cantor Agreement for aggregate net
proceeds of $27.9 million. During the year ended December 31, 2017, approximately 11.0 million shares of our common stock were
sold under the Prior Cantor Agreement for aggregate net proceeds of $30.3 million. The issuance and sale of these shares by us
pursuant to the Amended Cantor Agreement are registered under the Securities Act of 1933, as amended. At December 31, 2018, we
had approximately $41.6 million of common stock available to be sold under the Amended Cantor Agreement.
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Debt Agreement
Prior to December 31, 2016, we maintained a five-year loan and security agreement with Oxford Finance, or the Term Loan
Agreement, under which we had borrowed $20.0 million. The borrowings were set to mature on June 1, 2019, with various interest
only periods.
On April 27, 2017, the Term Loan Agreement was amended to include an additional interest-only period under the Term Loan
Agreement. As amended, we were required to make interest only payments from May 2017 through December 2017 followed by
eighteen months of equal principal and interest payments thereafter. We were also required to make a final payment equal to 7% of the
principal amounts drawn payable on the earlier to occur of maturity or prepayment.
On July 31, 2017, we entered into an amended and restated loan and security agreement, or the Amended Credit Agreement, which
amended and restated the Term Loan Agreement in its entirety. The Amended Credit Agreement provided for secured growth capital
term loans, or 2017 Term Loans, of up to $40.0 million. All of our current and future assets, excluding our intellectual property and
35% of our investment in Cerus Europe B.V., are secured for the borrowings under the Amended Credit Agreement. The 2017 Term
Loans were available in two tranches. The first tranche of $30.0 million, or 2017 Term Loan A, was drawn by us on July 31, 2017,
with the proceeds in part to repay in full all of the outstanding borrowings under the Term Loan Agreement of $17.6 million and the
final payment of the Term Loan Agreement of $1.4 million. The availability of the second tranche of $10.0 million, or 2017 Term
Loan B, expired on May 14, 2018, and we did not elect to draw the 2017 Term Loan B. The 2017 Term Loan A bears interest at a rate
equal to the greater of (i) 8.01% and (ii) the three-month U.S. LIBOR rate plus 6.72%. The interest rate on the 2017 Term Loan A at
December 31, 2018, was approximately 9.53%. We will also be required to make a final payment fee of 8.00% of the principal
amounts of the 2017 Term Loan A. As of December 31, 2018, our indebtedness under the 2017 Term Loan A was approximately
$29.9 million. The Amended Credit Agreement contains certain nonfinancial covenants, with which we were in compliance at
December 31, 2018.
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—Revenue is recognized in accordance with that core principle by applying the following five steps: (1) identify the
contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate
the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a
performance obligation.
The main source of our revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma, or the
platelet and plasma systems or disposable kits, UVA illumination devices, or illuminators, spare parts and storage solutions, and
maintenance services of illuminators. We sell the platelet and plasma systems directly to blood banks, hospitals, universities,
government agencies, as well as to distributors in certain regions. For all sales of our INTERCEPT Blood System products, we use a
binding purchase order or signed sales contract as evidence of a contract and satisfaction of our policy. Generally, our contracts with
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. The contracts with customers can include various combinations of products, and to a lesser extent, services. We
must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or
are accounted for as a combined performance obligation. We must allocate the transaction price to each performance obligation on a
relative standalone selling price, or SSP basis, and recognize the revenue when the performance obligation is satisfied. We determine
the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, we
estimate the amount of variable consideration that should be included in the transaction price. Product revenue is recognized upon
transfer of control of promised products or services to customers in an amount that reflects the consideration that we expect to receive
in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage
solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are
recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits.
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Freight costs charged to customers are recorded as a component of product revenue. Taxes invoiced to our customers and remitted to
governments are recorded on a net basis, which excludes such tax from product revenue.
• Government contract 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 18 to 24 months shelf lives 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
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—We perform an impairment test on our goodwill annually on August 31 of each fiscal year or
more frequently if indicators of impairment exist. The test for goodwill impairment may be addressed 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 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 goodwill impairment test. We may choose not to perform the qualitative assessment to test goodwill for impairment
and proceed directly to the quantitative impairment test; however, we may revert to the qualitative assessment to test goodwill for
impairment in any subsequent period. The quantitative goodwill impairment test 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. 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, limited to the carrying amount of goodwill in our one reporting unit. On August 31, 2018, we performed our
annual review of goodwill as described above and determined that goodwill was not impaired during the year ended December 31,
2018. 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
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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, 2018 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 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.
For our stock-based awards issued to non-employees, the measurement date at which the fair value of the stock-based award is
measured is 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.
• 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 substantially 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 2017, California tax returns through 2017, and Netherlands tax
returns for years 2015 through 2017 remain subject to examination by the taxing jurisdictions.
Results of Operations
Years Ended December 31, 2018, 2017 and 2016
Revenue
(in thousands, except percentages)
Product revenue...................................................................... $
Government contract revenue ................................................
Total revenue .................................................................... $
2018
60,908 $
15,143
76,051 $
2017
43,568 $
7,758
51,326 $
2016
37,183
2,092
39,275
Year Ended December 31,
% Change
2018
to 2017
2017
to 2016
40%
95%
48%
17%
271%
31%
Product revenue increased by $17.3 million during the year ended December 31, 2018, compared to the year ended December 31,
2017, primarily due to year-over-year sales volume growth in disposable kit sales in Europe, the majority of which resulted from the
nationwide adoption of the platelet system in France, and increased disposable kit sales for the platelet system in the U.S. and, to a
lesser extent, improved foreign exchange rates for the Euro. These increases were partially offset by decreased average selling prices
to our largest customers.
Product revenue increased by $6.4 million during the year ended December 31, 2017, compared to the year ended December 31, 2016,
primarily due to the year-over-year increased demand of our disposable kits for our platelet system as a result of growth in EMEA,
including the commencement of the national rollout of INTERCEPT in France, and sales to U.S. customers that were entering routine
use of the platelet system, and, to a lesser extent, due to improved foreign exchange rates for the Euro. The year-over-year growth in
sales of disposable kits for our platelet system was partially offset by decreased sales of disposable kits for our plasma products.
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We anticipate product revenue for INTERCEPT disposable kits will increase in future periods as a result of the expected expansion of
U.S. sales as increased market acceptance and adoption of the INTERCEPT Blood System in geographies where commercialization
efforts are underway. However, a deterioration of the Euro relative to the U.S. dollar has in the past and could in the future have a
material impact on our product revenues, as the majority of our product revenue is expected to come from Euro denominated markets
over the near term. As a result of these and other factors, the historical results may not be indicative of INTERCEPT Blood System
product revenue in the future.
We recognized $15.1 million, $7.8 million and $2.1 million of revenue from our BARDA agreement during the years ended
December 31, 2018, 2017 and 2016, respectively, as a result of the direct and indirect contract costs incurred under the BARDA
agreement. As our RedeS study continues to enroll patients, as we anticipate enrolling patients in our ReCePI study and as we plan for
a potential additional Phase 3 study for chronic anemia, and as the other qualified clinical and development activities potentially
increase under the exercised Option Periods, we anticipate that reported BARDA revenue will increase.
Cost of Product Revenue
Our cost of product revenue consists of the cost of the INTERCEPT Blood System sold, provisions for obsolete, slow-moving and
unsaleable product, certain order fulfillment costs, to the extent applicable, and costs for idle facilities. Inventory is accounted for on a
first-in, first-out basis.
(in thousands, except percentages)
Cost of product revenue ......................................................... $
2018
31,634 $
2017
22,531 $
2016
20,295
Year Ended December 31,
% Change
2018
to 2017
2017
to 2016
40%
11%
Cost of product revenue increased by $9.1 million during the year ended December 31, 2018, compared to the year ended
December 31, 2017. The increase was primarily due to the increase in the volume of INTERCEPT platelet kits sold in the current year
compared to the prior year. Cost of product revenue was also impacted by less favorable foreign currency exchange rates related to
inventory production compared to prior year.
Cost of product revenue increased by $2.2 million during the year ended December 31, 2017, compared to the year ended December
31, 2016. The increase was primarily due to the increase of sales in the current year compared to the prior year. Cost of product
revenue was also impacted by the quantity of disposable kits sold during the reported periods and the quantity of illuminators sold, all
with generally offsetting effects.
Our gross margin on product sales was 48% during the year ended December 31, 2018, compared to 48% during the year ended
December 31, 2017. Gross margin on product sales remained relatively flat in both periods.
Our gross margin on product sales was 48% during the year ended December 31, 2017, up from 45% during the year ended December
31, 2016. The increase in gross margins on product sales was primarily due to increased demand for disposable kits for the platelet
system and favorable Euro foreign exchange rates.
Changes in our gross margin on product sales are affected by various factors, including the volume of product manufactured and the
relative per unit pricing in our agreement with Fresenius, 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 products are sold. 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 on product sales. Our gross margins on product sales may be impacted in
the future based on all of these and other criteria.
We expect to build inventory levels that will be sufficient to meet forecasted demand and plan to continue to manufacture at levels
above those produced in 2018.
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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....................................................... $
2018
42,564 $
2017
33,710 $
2016
31,322
Year Ended December 31,
% Change
2018
to 2017
2017
to 2016
26%
8%
Research and development expenses increased $8.9 million during the year ended December 31, 2018, compared to the year ended
December 31, 2017, primarily due to costs associated with clinical development of our INTERCEPT red blood cell system, our pursuit
of supplemental approvals for the platelet and plasma systems, and activities related to the BARDA agreement.
Research and development expenses increased $2.4 million during the year ended December 31, 2017, compared to the year ended
December 31, 2016, primarily due to the increased headcount costs and costs associated with clinical development of our
INTERCEPT red blood cell system, our pursuit of supplemental approvals for the platelet and plasma systems, activities related to the
BARDA agreement, and increased headcount related costs.
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 our December 2018 CE Mark submission for our red blood cell system in
Europe, new product development and product enhancements, including potential new label claims, 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, and facility and
infrastructure related expenses, and insurance premiums.
(in thousands, except percentages)
Selling, general and administrative ........................................ $
2018
56,841 $
2017
52,615 $
2016
48,955
Year Ended December 31,
% Change
2018
to 2017
2017
to 2016
8%
7%
Selling, general, and administrative expenses increased by $4.2 million during the year ended December 31, 2018, compared to the
year ended December 31, 2017, primarily due to headcount and compensation related costs.
Selling, general, and administrative expenses increased by $3.7 million during the year ended December 31, 2017, compared to the
year ended December 31, 2016, primarily due to increased commercial activity in the U.S. and, to a lesser extent, the costs associated
with administering the contract with BARDA for INTERCEPT red blood cell development.
We anticipate our selling, general, and administrative spending to remain relatively consistent over the coming year.
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Non-Operating Income (Expense), Net
Non-operating income (expense), net consists of foreign exchange (loss) gain, 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)
Foreign exchange (loss) gain ...................................................
Interest expense........................................................................
Other income, net.....................................................................
Total non-operating (expense) income, net ........................ $
2018
2017
2016
(87)
(4,008)
1,748
(2,347) $
(10)
(3,022)
3,864
832 $
21
(2,445)
1,140
(1,284)
2018
to 2017
2017
to 2016
770%
33%
(55%)
(382%)
(148%)
24%
239%
(165%)
Year Ended December 31,
% Change
Foreign exchange gain (loss)
Foreign exchange loss remained relatively flat during the year ended December 31, 2018, compared to the year ended December 31,
2017, and during the year ended December 31, 2017, compared to the year ended December 31, 2016, primarily due to stabilized
foreign exchange rates for the Euro.
Interest expense
Interest expense increased $1.0 million during the year ended December 31, 2018, compared to the year ended December 31, 2017,
primarily due to increased average outstanding debt balance, and, to a lesser extent, due to the increased interest rate, under our
Amended Credit Agreement with Oxford, see discussion under the heading “Debt” below.
Interest expense increased by $0.6 million for the year ended December 31, 2017, compared to the year ended December 31, 2016,
primarily due to the increased average outstanding debt balance under our Amended Credit Agreement with Oxford, see discussion
under the heading “Debt” below.
Other income, net
Other income, net decreased by $2.1 million during the year ended December 31, 2018, compared to the year ended December 31,
2017, primarily due to the realized gain from the sale of our remaining shares of Aduro Biotech, Inc., or Aduro, common stock of
approximately $3.5 million, during the year ended December 31, 2017, partially offset by the increase of interest income from our
investments in marketable securities during the year ended December 31, 2018.
Other income, net increased by $2.7 million during the year ended December 31, 2017, compared to the year ended December 31,
2016, primarily due to the realized gain from the sale of our remaining shares of Aduro common stock of approximately $3.5 million.
Provision for Income Taxes
(in thousands, except percentages)
Provision for income taxes....................................................... $
Year Ended December 31,
2018
2017
2016
% Change
2018
to 2017
2017
to 2016
229 $
3,887 $
175
(94%)
2,121%
For the year ended December 31, 2018, we recorded a tax expense of $0.2 million, which was primarily a result of our Cerus Europe
B.V. subsidiary’s operating profit. For the year ended December 31, 2017, we recorded a tax expense of $3.9 million, which was
primarily due to the sale of our shares of Aduro. 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.
Due to our history of cumulative operating losses, management has concluded that, after considering all of the available objective
evidence, it is not likely that all our net deferred tax assets will be realized. Accordingly, substantially all of our U.S. deferred tax
assets continue to be subject to a valuation allowance as of December 31, 2018.
On December 22, 2017, new tax legislation, Tax Cuts and Jobs Act, or the Tax Act, was signed into law, which significantly changes
the Internal Revenue Code of 1986, as amended. The Tax Act did not impact the tax expense recorded for 2017 or 2018 due to our
continuing operating losses and the valuation allowance against substantially all of our deferred tax assets, but did have other tax
related effects. One component of the Tax Act is a provision which required the deemed distribution of the accumulated earnings of
Cerus Europe B.V. during the year ended December 31, 2017. As a result, we realized a deemed income inclusion of $3.2 million
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associated permanently reinvested earnings in our subsidiary. This deemed inclusion reduced the net operating loss for the year but did
not result in any cash outlays. We did not make any actual distribution of accumulated earnings and continue to maintain the funds as
permanently reinvested outside the U.S.
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, cash from product sales and reimbursements under our BARDA agreement.
At December 31, 2018, we had cash, cash equivalents, and restricted cash of $31.6 million, of which $28.9 million was included in
cash and cash equivalents, and $2.7 million was included as restricted cash. At December 31, 2017, we had cash, cash equivalents, and
restricted cash of $13.9 million, of which $13.7 million was included in cash and cash equivalents, and $0.2 million was included as
restricted cash. Our cash equivalents primarily consist of money market instruments, which are classified for accounting purposes as
available-for-sale. In addition, we had $88.7 million of short-term investments at December 31, 2018, and $47.0 million at
December 31, 2017. We also had total indebtedness of approximately $29.9 million and $29.8 million under our Amended Credit
Agreement at December 31, 2018 and December 31, 2017, respectively. 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.
Operating Activities
Net cash used in operating activities was $31.2 million during the year ended December 31, 2018, compared to $52.2 million net cash
used during the year ended December 31, 2017. The decrease in net cash used in operating activities was primarily related to increased
product sales and reimbursements from the BARDA agreement, the timing of accounts receivable collections, and the timing of
payments and purchases related to inventories and research and development activities during the year ended December 31, 2018, as
compared to the year ended December 31, 2017.
Net cash used in operating activities was $52.2 million during the year ended December 31, 2017, compared to $53.5 net cash used
during the year ended December 31, 2016. The decrease in net cash used in operating activities was primarily related to the
Manufacturing and Development Payments to Fresenius during the year ended December 31, 2016, which did not reoccur during the year
ended December 31, 2017. The decrease in net cash used in operating activities was also related to the increased product sales and
reimbursements from the BARDA agreement, partially offset by the increase in our accounts receivables as a result of the timing of cash
receipts during the year ended December 31, 2017, as compared to the same period in 2016.
Investing Activities
Net cash used in investing activities was $43.8 million during year ended December 31, 2018, compared to $0.4 million net cash
provided by investing activities during the year ended December 31, 2017. The change period over period was primarily the result of
higher purchases of investments due to the proceeds from our January 2018 public offering of common stock, and lower proceeds from
the sale of our marketable securities during the year ended December 31, 2018, as compared to the same period in 2017.
Net cash provided by investing activities was $0.4 million during the year ended December 31, 2017, compared to $19.9 million net
cash used in investing activities during the year ended December 31, 2016. The change period over period was primarily the result of
lower purchases of investments, and higher proceeds from the sale of our Aduro common stock and maturities of investments in
marketable securities, during the year ended December 31, 2017, as compared to the same period in 2016.
Financing Activities
Net cash provided by financing activities was $92.8 million during the year ended December 31, 2018, compared to $43.0 million net
cash provided during the year ended December 31, 2017. The increase in net cash provided by financing activities was primarily due
to the proceeds of approximately $57.2 million, net of the underwriting discounts and other issuance costs, received from our January
2018 public offering of common stock, partially offset by the proceeds received from the 2017 Term Loans described in more detail
above during the year ended December 31, 2017.
Net cash provided by financing activities was $43.0 million during the year ended December 31, 2017, compared to $24.6 million net
cash provided during the year ended December 31, 2016. The change was primarily due to the proceeds received from the 2017 Term
Loans, and an increase in public offering proceeds, partially offset by the repayment of Term Loans A and B under the original Term
Loan Agreement, during the year ended December 31, 2017.
64
Working Capital
Working capital increased to $94.2 million at December 31, 2018, from $66.8 million at December 31, 2017, primarily due to the cash
received from the public offering of our common stock in January 2018.
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, 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., 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. While 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, if we are unable to generate sufficient product revenue, or access
sufficient funds under our BARDA agreement or the public and private equity and debt capital markets, we may be unable to execute
successfully on our operating plan. 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 the Amended Credit Agreement 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, financial performance covenants 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.
While we expect to receive significant funding under our 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 and our ability to achieve the required milestones under the agreement. 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 generate sufficient perquisite Phase 3 clinical data and/or reach
agreement with the FDA on an additional Phase 3 clinical trial for chronic anemia in the U.S. 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 any additional portions of the funding contemplated
65
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.
Commitments and Off-Balance Sheet Arrangements
Off-balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of December 31, 2018 and 2017.
Contractual Commitments
The following summarizes our contractual commitments at December 31, 2018:
(in thousands)
Debt ........................................................................................ $
Minimum purchase requirements...........................................
Manufacturing and development obligations.........................
Operating leases .....................................................................
Other commitments................................................................
Total contractual obligations ............................................ $
Debt
Total
1 year
2 - 3 years
4 - 5 years
37,835 $
21,852
6,294
33,642
643
100,266 $
10,436 $
13,051
6,294
3,535
594
33,910 $
19,839 $
5,705
—
6,103
49
31,696 $
7,560 $
2,739
—
5,314
—
15,613 $
After 5 years
—
357
—
18,690
—
19,047
See “Equity and Debt Agreements—Debt Agreement” above for more information on the Amended Credit Agreement.
Minimum Purchase Requirements
Our minimum purchase commitments include certain components of our INTERCEPT Blood System which we purchase from third
party manufacturers.
Manufacturing and Development Obligations
See “Fresenius” above for more information on the payment of €5.5 million which we are obligated to pay in August 2019 for an
amendment to the Supply Agreement with Fresenius.
Operating Leases
We generally lease our office facilities and certain equipment and automobiles under non-cancelable leases with initial terms in excess
of one year that require us to pay operating costs, property taxes, insurance and maintenance. The leases expire at various dates
through 2030, with certain of the leases providing for renewal options, provisions for adjusting future lease payments based on
consumer price index, and the right to terminate the lease early. Our leased facilities qualify as operating 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 our landlord financed leasehold
improvements, which are in addition to the leases we have for office and laboratory space. 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.
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 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, 2018, 2017 and 2016. Adverse global economic conditions have
had, and may continue to have, a negative impact on the market values of potential investments.
66
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Risk
At December 31, 2018, we held cash, cash equivalents, short-term investments and investments in marketable equity securities of
$117.6 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, 2018 were 2.25%.
Our exposure to market rate risk for changes in interest rates relates primarily to our money market instruments, corporate debt
securities and the amounts borrowed pursuant to the Amended Credit 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.
With respect to the Amended Credit Agreement, we are exposed to risks associated with changes in interest rates in connection with
our borrowings under the Amended Credit Agreement. Based on our indebtedness under the Amended Credit Agreement of $29.9
million as of December 31, 2018, and the interest rate on such borrowings then in effect, a hypothetical 100 basis point increase in
interest rates would increase our net interest expense in 2018 by approximately $0.3 million.
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, 2018, would have negatively impacted our annual financial results by $0.5 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.
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.
67
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation under the supervision and with the participation of management, including our principal executive
officer and principal financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities
Exchange Act of 1934, as amended) as of the end of the period covered by this Annual Report on Form 10-K. Based on their
evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were
effective as of December 31, 2018.
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, that based on their evaluation as of the
end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were effective to provide
reasonable assurance that the objective of our disclosure control system were met.
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, 2018.
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, 2018, our internal control over financial reporting was effective.
The effectiveness of our internal control over financial reporting as of December 31, 2018, 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,
2018, which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
68
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Cerus Corporation
Opinion on Internal Control over Financial Reporting
We have audited Cerus Corporation’s internal control over financial reporting as of December 31, 2018, 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). In our opinion, Cerus Corporation (the Company) maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2018, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(PCAOB), the consolidated balance sheets of the Company as of December 31, 2018 and 2017, 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,
2018, and the related notes and our report dated February 26, 2019 expressed an unqualified opinion thereon.
Basis for Opinion
The Company'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 are a public accounting firm registered with the PCAOB and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. 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.
Definition and Limitations of Internal Control over Financial Reporting
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.
/s/ Ernst & Young LLP
Redwood City, California
February 26, 2019
69
Item 9B. Other Information
None.
70
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 2019 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.
71
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, 2018 and 2017 ....................................................................................................
Consolidated Statements of Operations for the three years ended December 31, 2018 ....................................................................
Consolidated Statements of Comprehensive Loss for the three years ended December 31, 2018....................................................
Consolidated Statements of Stockholders’ Equity for the three years ended December 31, 2018....................................................
Consolidated Statements of Cash Flows for the three years ended December 31, 2018...................................................................
Notes to Consolidated Financial Statements......................................................................................................................................
Page
79
80
81
82
83
84
85
Other information is omitted because it is either presented elsewhere, is inapplicable or is immaterial as defined in the
instructions.
(b)
Exhibits.
Exhibit Number
Description of Exhibit
3.1(20)
Amended and Restated Certificate of Incorporation of Cerus Corporation.
3.2(20)
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.
3.3(20)
Certificate of Designation of Series C Junior Participating Preferred Stock of Cerus Corporation.
3.4(25)
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Cerus Corporation.
3.5(6)
Amended and Restated Bylaws of Cerus Corporation.
4.1(1)
Specimen Stock Certificate.
4.2(12)
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.).
4.3(13)
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).
Supply and/or Manufacturing Agreements
10.1(26)† Amended and Restated Supply Agreement, dated April 21, 2014, by and between Cerus Corporation and Purolite
Corporation.
10.2(34)† Amended and Restated Supply and Manufacturing Agreement, dated April 1, 2017, by and between Cerus Corporation
and Porex Corporation.
10.3(38) †
First Amendment to Supply and Manufacturing Agreement, by and between Cerus Corporation and Porex Corporation,
dated June 22, 2018.
10.4(30)† Amended and Restated Manufacturing and Supply Agreement, dated October 19, 2015, by and between Cerus
Corporation and Fresenius Kabi Deutschland GmbH.
10.5(38) † Amendment to Amended and Restated Manufacturing and Supply Agreement, by and between Cerus Corporation and
Fresenius Kabi Deutschland GmbH, effective as of August 10, 2018.
72
10.6(8)† Manufacturing and Supply Agreement, dated September 30, 2008, by and between Cerus Corporation and NOVA
Biomedical Corporation.
10.7(31)† Amendment #1 to the Manufacturing and Supply Agreement, dated March 15, 2016, by and between NOVA
Biomedical Corporation and Cerus Corporation.
10.8(17)† Amended and Restated Supply Agreement, dated as of September 1, 2011, between Cerus Corporation and Ash
Stevens Inc.
10.9(22)† Addendum 1 to Amended and Restated Supply Agreement, dated August 1, 2013, by and between Cerus Corporation
and Ash Stevens, Inc.
Loan and Security Agreements
10.10(35)† Amended and Restated Loan and Security Agreement, dated July 31, 2017, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
10.11(35)
First Amendment to Loan and Security Agreement, effective July 31, 2017, by and among Cerus Corporation and
Oxford Finance LLC, as collateral agent and a lender.
Real Estate Lease Agreements
10.12(4)
Standard Industrial/Commercial Single-Tenant Lease-Net, dated October 12, 2001 between Cerus Corporation and
California Development, Inc.
10.13(7)
Second Amendment to Standard Industrial/Commercial Single-Tenant Lease-Net, dated as of September 18, 2008
between Cerus Corporation and California Development, Inc.
10.14(14)
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.
10.15(23) Real Property Lease, dated June 20, 2013, between Cerus Corporation and S. P. Cuff as Managing Partner of the
Redwoods Business Center LP.
10.16(27)
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.
10.17(34)
Letter, dated April 25, 2017, 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 L.P.
10.18(36)
Lease, dated February 16, 2018, between Cerus Corporation and 1200 Concord LLC.
10.19(37)
First Amendment to Lease, dated May 11, 2018, between Cerus Corporation and 1200 Concord LLC.
10.20(38)
Second Amendment to Lease, dated August 10, 2018, between Cerus Corporation and 1200 Concord LLC.
10.21
Third Amendment to Lease, dated October 5, 2018, between Cerus Corporation and 1200 Concord LLC.
10.22
Fourth Amendment to Lease, dated November 30, 2018, between Cerus Corporation and 1200 Concord LLC.
Employment Agreements or Offer Letters
10.23(16)* Employment Letter, by and between Cerus Corporation and William M. Greenman, dated May 12, 2011.
73
10.24(21)* Addendum to Employment Agreement for William M. Greenman, dated December 5, 2012.
10.25(37)*
Amendment to Employment Letter, by and between Cerus Corporation and William M. Greenman, dated April 17,
2018.
10.26(23)* Employment Letter, by and between Cerus Corporation and Laurence Corash, dated July 30, 2009.
10.27(15)* Employment Letter, by and between Cerus Corporation and Laurence Corash, dated March 2, 2010.
10.28(12)* Employment Letter for Kevin D. Green, dated May 1, 2009.
10.29(37)* Amendment to Employment Letter, by and between Cerus Corporation and Kevin Green, dated April 17, 2018.
10.30(21)* Employment Letter, by and between Cerus Corporation and Chrystal Menard, dated October 19, 2012.
10.31(23)* Employment Letter, by and between Cerus Corporation and Carol Moore, dated December 14, 2007.
10.32(29)* Employment Letter, by and between Cerus Corporation and Richard J. Benjamin MBChB, PhD, FRCPath, dated
May 12, 2015.
10.33(32)* Employment Letter, by and between Cerus Corporation and Vivek Jayaraman, dated May 31, 2016.
Stock Plans and Related Forms
10.34(1)*
1996 Equity Incentive Plan (See Exhibit 10.2 to Form S-1 Registration Statement filed with the SEC on September 4,
1996).
10.35(1)*
Form of Incentive Stock Option Agreement under the 1996 Equity Incentive Plan (See Exhibit 10.3 to Form S-1
Registration Statement filed with the SEC on September 4, 1996).
10.36(1)*
Form of Nonstatutory Stock Option Agreement under the 1996 Equity Incentive Plan (See Exhibit 10.4 to Form S-1
Registration Statement filed with the SEC on September 4, 1996).
10.37(28)* Amended and Restated 1996 Employee Stock Purchase Plan, effective June 10, 2015.
10.38(2)*
1998 Non-Officer Stock Option Plan (See Exhibit 99.1 to Form S-8 Registration Statement filed with the SEC on
March 24, 1999).
10.39(3)*
1999 Equity Incentive Plan, adopted April 30, 1999, approved by stockholders July 2, 1999 (See Exhibit 99.1 to Form
S-8 Registration Statement filed with the SEC on August 4, 1999).
10.40(5)*
1999 Non-Employee Directors’ Stock Option Sub-Plan, amended December 4, 2002.
10.41(34)* Amended and Restated 2008 Equity Incentive Plan, effective June 7, 2017.
10.42(18)* Form of Option Agreement for employees under the Amended and Restated 2008 Equity Incentive Plan.
10.43(18)* Form of Option Agreement for non-employee directors under the Amended and Restated 2008 Equity Incentive Plan.
10.44(18)* Form of Restricted Stock Unit Agreement under the Amended and Restated 2008 Equity Incentive Plan.
10.45(37)*
Form of Restricted Stock Unit Agreement under the Amended and Restated 2008 Equity Incentive Plan, amended as of
April 17, 2018.
10.46(37)*
Form of Restricted Stock Unit Agreement for Non-Employee Directors under the Amended and Restated 2008 Equity
Incentive Plan, amended as of April 17, 2018.
74
Other Compensatory Plans or Agreements
10.47(21)* Bonus Plan for Senior Management of Cerus Corporation, as amended December 5, 2012.
10.48(37)* Cerus Corporation Change of Control Severance Benefit Plan, amended as of April 17, 2018.
10.49(11)* Form of Severance Benefits Agreement.
10.50(36)* Amended and Restated Non-Employee Director Compensation Policy, effective March 2, 2018.
10.51(36)*
2017 and 2018 Executive Officer Compensation Arrangements.
Other Material Agreements
10.52(1)
Form of Indemnity Agreement entered into between Cerus Corporation and each of its directors and executive officers.
10.53(10)
Form of Amended and Restated Indemnity Agreement, adopted April 24, 2009.
10.54(19) Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, by and between Cerus Corporation and
Cantor Fitzgerald & Co.
10.55(24) Amendment No 1. to Controlled Equity OfferingSM Sales Agreement, dated March 21, 2014, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
10.56(31) Amendment No. 2 to Controlled Equity OfferingSM Sales Agreement, dated May 5, 2016, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
10.57(34) Amendment No. 3 to Controlled Equity OfferingSM Sales Agreement, dated August 4, 2017, by and between Cerus
Corporation and Cantor Fitzgerald & Co.
10.58(14)† 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).
21.1
List of Registrant’s subsidiaries.
23.1
Consent of Independent Registered Public Accounting Firm.
24.1
Power of Attorney (see signature page).
31.1
31.2
Certification of the Principal Executive Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
Certification of the Principal Financial Officer of Cerus Corporation pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002.
32.1(39)
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002.
101.INS
XBRL Instance Document.
101.SCH
XBRL Taxonomy Extension Schema Document.
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF XBRL Taxonomy Extension Definition Linkbase Document.
75
101.LAB XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
.
XBRL Taxonomy Extension Presentation Linkbase Document.
†
*
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
Certain portions of this exhibit are subject to a confidential treatment order.
Compensatory Plan.
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.
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-8, dated
March 24, 1999.
Incorporated by reference to the like-described exhibit to the Registrant’s Registration Statement on Form S-8, dated
August 4, 1999.
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.
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 Current Report on Form 8-K, filed with the
SEC on June 19, 2008.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
76
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(26)
(27)
(28)
(29)
(30)
(31)
(32)
(33)
(34)
(35)
(36)
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.
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.
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.
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.
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.
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.
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.
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.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2015.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2015.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2015.
Incorporated by reference to the like-described exhibit to Registrant's Annual Report on Form 10-K, for the year ended
December 31, 2015.
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 Registrant's Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2016.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2017.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2017.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2017.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended March 31, 2018.
77
(37)
(38)
(39)
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended June 30, 2018.
Incorporated by reference to the like-described exhibit to Registrant’s Quarterly Report on Form 10-Q, for the quarter
ended September 30, 2018.
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.
Item 16.
Form 10-K Summary
None.
78
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Cerus Corporation
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Cerus Corporation (the Company) as of December 31, 2018 and
2017, 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, 2018, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the
Company at December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the three years in the period
ended December 31, 2018, 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)
(PCAOB), the Company's internal control over financial reporting as of December 31, 2018, 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 February 26, 2019 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the
Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to
be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used
and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe
that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young LLP
We have served as the Company's auditor since 1991.
Redwood City, California
February 26, 2019
79
CERUS CORPORATION
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
Current assets:
ASSETS
Cash and cash equivalents ................................................................................................ $
Short-term investments .....................................................................................................
Accounts receivable..........................................................................................................
Inventories ........................................................................................................................
Prepaid and other current assets........................................................................................
Total current assets......................................................................................................
Non-current assets:
Property and equipment, net .............................................................................................
Goodwill ...........................................................................................................................
Intangible assets, net .........................................................................................................
Restricted cash ..................................................................................................................
Other assets .......................................................................................................................
Total assets .................................................................................................................. $
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable.............................................................................................................. $
Accrued liabilities .............................................................................................................
Debt - current ....................................................................................................................
Manufacturing and development obligations – current ....................................................
Deferred product revenue - current...................................................................................
Total current liabilities ................................................................................................
Non-current liabilities:
Debt - non-current.............................................................................................................
Manufacturing and development obligations - non-current .............................................
Other non-current liabilities..............................................................................................
Total liabilities.............................................................................................................
Commitments and contingencies ...........................................................................................
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000 shares authorized, issuable in series; zero
shares issued and outstanding at December 31, 2018 and 2017, respectively...............
Common stock, $0.001 par value; 225,000 shares authorized; 136,853 and 115,555
shares issued and outstanding at December 31, 2018 and 2017, respectively...............
Additional paid-in capital .................................................................................................
Accumulated other comprehensive loss ...........................................................................
Accumulated deficit..........................................................................................................
Total stockholders' equity............................................................................................
Total liabilities and stockholders' equity ............................................................... $
See accompanying Notes to Consolidated Financial Statements.
December 31,
2018
2017
28,859 $
88,718
8,752
13,539
7,034
146,902
8,130
1,316
334
2,728
4,050
163,460 $
18,595 $
19,800
7,857
5,928
498
52,678
22,013
—
4,250
78,941
13,683
47,013
12,415
14,457
2,330
89,898
2,119
1,316
536
247
4,128
98,244
10,974
11,712
—
—
445
23,131
29,798
5,766
609
59,304
—
—
136
863,531
(281)
(778,867)
84,519
163,460 $
115
760,225
(97)
(721,303)
38,940
98,244
80
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
2018
Year Ended December 31,
2017
2016
Product revenue ................................................................................................. $
Cost of product revenue .....................................................................................
Gross profit on product revenue ...................................................................
Government contract revenue ............................................................................
Operating expenses:
Research and development ...........................................................................
Selling, general and administrative ..............................................................
Impairment of long-lived assets ...................................................................
Total operating expenses.........................................................................
Loss from operations..........................................................................................
Non-operating (expense) income, net:
Foreign exchange (loss) gain........................................................................
Interest expense ............................................................................................
Other income, net .........................................................................................
Total non-operating (expense) income, net .......................................................
Loss before income taxes...................................................................................
Provision for income taxes.................................................................................
Net loss ......................................................................................................... $
60,908 $
31,634
29,274
15,143
42,564
56,841
—
99,405
(54,988)
(87)
(4,008)
1,748
(2,347)
(57,335)
229
(57,564) $
43,568 $
22,531
21,037
7,758
33,710
52,615
—
86,325
(57,530)
(10)
(3,022)
3,864
832
(56,698)
3,887
(60,585) $
37,183
20,295
16,888
2,092
31,322
48,955
150
80,427
(61,447)
21
(2,445)
1,140
(1,284)
(62,731)
175
(62,906)
Net loss per share:
Basic ............................................................................................................. $
Diluted ..........................................................................................................
(0.44) $
(0.44)
(0.56) $
(0.56)
(0.62)
(0.62)
Weighted average shares outstanding used for calculating net loss per share:
Basic .............................................................................................................
Diluted ..........................................................................................................
131,663
131,663
108,221
108,221
101,826
101,826
See accompanying Notes to Consolidated Financial Statements.
81
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Net loss ............................................................................................................ $
Other comprehensive loss:
Unrealized losses on available-for-sale investments, net of taxes ..............
Comprehensive loss......................................................................................... $
2018
Year Ended December 31,
2017
2016
(57,564) $
(60,585) $
(62,906)
(184)
(57,748) $
(200)
(60,785) $
(7,186)
(70,092)
See accompanying Notes to Consolidated Financial Statements.
82
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
Shares
99,095 $
—
—
Balance at December 31, 2015 ....................................
Net loss......................................................................
Other comprehensive loss .........................................
Issuance of common stock from public offering, net
of offering costs......................................................
Issuance of common stock from exercise of stock
options and purchases from ESPP..........................
Stock-based compensation ........................................
854
—
Balance at December 31, 2016 .................................... 103,475
—
—
Net loss......................................................................
Other comprehensive loss .........................................
Issuance of common stock from public offering, net
of offering costs......................................................
Issuance of common stock from exercise of stock
options, vesting of restricted stock units, and
purchases from ESPP .............................................
Stock-based compensation ........................................
1,094
—
Balance at December 31, 2017 .................................... 115,555
—
—
Net loss......................................................................
Other comprehensive loss .........................................
Issuance of common stock from public offering, net
of offering costs......................................................
Issuance of common stock from exercise of stock
options, vesting of restricted stock units, and
purchases from ESPP .............................................
Stock-based compensation ........................................
3,096
—
Balance at December 31, 2018 .................................... 136,853 $
Common Stock
Amount
Additional
Paid-in
Capital
99 $ 685,189 $
—
—
—
—
Accumulated
Other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders'
Equity
7,289 $ (597,812) $
(62,906)
—
—
(7,186)
94,765
(62,906)
(7,186)
3,526
3
21,978
—
—
21,981
3,067
1
—
8,065
103 718,299
—
—
—
—
—
—
103
—
(200)
—
—
(660,718)
(60,585)
—
3,068
8,065
57,787
(60,585)
(200)
10,986
11
30,145
—
—
30,156
2,426
1
—
9,355
115 760,225
—
—
—
—
—
—
(97)
—
(184)
—
—
(721,303)
(57,564)
—
2,427
9,355
38,940
(57,564)
(184)
18,202
18
85,067
—
—
85,085
7,845
3
—
10,394
136 $ 863,531 $
—
—
—
—
(281) $ (778,867) $
7,848
10,394
84,519
See accompanying Notes to Consolidated Financial Statements.
83
CERUS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
2018
2017
2016
(57,564) $
(60,585) $
(62,906)
Operating activities
Net loss .................................................................................................................. $
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization.........................................................................
Stock-based compensation...............................................................................
Non-cash interest expense ...............................................................................
Loss on disposal of property and equipment ...................................................
Deferred income taxes .....................................................................................
Impairment of long-lived assets.......................................................................
Non-cash tax expense from realized 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 and other non-current liabilities......................................
Manufacturing and development obligations................................................
Deferred product revenue..............................................................................
Net cash used in operating activities .....................................................................
Investing activities
Capital expenditures ........................................................................................
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................................................................
Net proceeds from public offering...................................................................
Proceeds from loans.........................................................................................
Repayment of debt ...........................................................................................
Net cash provided by financing activities .............................................................
Net increase (decrease) 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 disclosure of cash flow information:
1,445
10,394
1,248
5
4
—
—
—
3,663
806
(2,744)
5,683
6,042
(266)
38
(31,246)
(1,144)
(80,701)
37,997
(43,848)
7,848
85,036
—
(133)
92,751
17,657
13,930
31,587 $
1,811
9,355
551
—
(119)
—
3,825
(3,466)
(5,547)
(2,092)
1,107
2,487
(507)
680
265
(52,235)
(353)
(68,792)
69,566
421
2,428
30,197
30,000
(19,625)
43,000
(8,814)
22,744
13,930 $
Cash paid for interest ....................................................................................... $
Cash paid for income taxes ..............................................................................
2,728 $
254
2,034 $
160
Non-cash investing activities:
Non-cash purchases of capital expenditures ....................................................
2,222
—
See accompanying Notes to Consolidated Financial Statements.
84
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
—
CERUS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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 nature and timing of satisfaction of performance obligations, the
timing when the customer obtains control of products or services, the standalone selling price (“SSP”) of performance obligations,
variable consideration, 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. The
Company bases its 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 adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”, on
January 1, 2018, using the modified retrospective method applied to the contracts which were not completed as of the date of
adoption. Revenue is recognized in accordance with that core principle by applying the following five steps: (1) identify the
contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate
the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a
performance obligation.
The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma
(“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and
maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals,
universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed
sales contract as evidence of a contract and satisfaction of its policy. 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. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company
must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or
are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance
obligation on a relative SSP basis, and recognize the revenue when the performance obligation is satisfied. The Company determines
the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the
Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount
method, to the extent it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Product
85
revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the
consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of
illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the
customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as
customers simultaneously consume and receive benefits. 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 with the Biomedical Advanced Research and Development
Authority (“BARDA”) that supports research and development of defined projects. See “Note 13 Development and License
Agreements—Agreement with BARDA” below. The contract generally provides for reimbursement of approved costs incurred under
the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s 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 government contract 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 under the government contract.
Disaggregation of Product Revenue
Product revenue by geographical locations of customers during the years ended December 31, 2018, 2017 and 2016, were as follows
(in thousands):
Product revenue:
Europe, Middle East and Africa ................................................................... $
North America ..............................................................................................
Other .............................................................................................................
Total product revenue ............................................................................. $
46,974 $
12,696
1,238
60,908 $
36,241 $
6,325
1,002
43,568 $
30,716
4,569
1,898
37,183
2018
Year Ended December 31,
2017
2016
Contract Balances
The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. Accounts
receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no
contract assets at December 31, 2018 and December 31, 2017.
Contract liabilities mainly consist of deferred product revenue related to maintenance services, unshipped products, and uninstalled
illuminators. Maintenance services are generally billed upfront at the beginning of each annual service period and recognized ratably
over the service period. The increase in the deferred product revenue balance for the year ended December 31, 2018, is primarily
driven by performance obligations not satisfied but invoiced as of December 31, 2018, offset by $0.4 million of revenue recognized
that were included in the deferred product revenue balance as of December 31, 2017.
The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an
original expected duration of one year or less.
Research and Development Expenses
Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of
the Company’s U.S. government contract. 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.
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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 under its U.S. 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 that are designated as available-for-sale and classified as short-term investments. 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 “Unrealized losses 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, if any, 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.
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
As of December 31, 2018, the Company’s “Restricted cash” primarily consisted of a $2.5 million of letter of credit relating to the
lease of the Company’s new office building. As of December 31, 2018 and December 31, 2017, 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, 2018, 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 two customers and three customers that accounted for more than 10% of the Company’s outstanding trade
receivables at December 31, 2018 and December 31, 2017, respectively. These customers cumulatively represented approximately
50% and 53% of the Company’s outstanding trade receivables at December 31, 2018 and December 31, 2017, respectively. To date,
the Company has not experienced collection difficulties from these customers.
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Inventories
At December 31, 2018 and December 31, 2017, 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 18 to 24 months shelf lives 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, 2018 and December 31, 2017, 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.
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, 2018 and December 31, 2017, the Company had $0.3 million and $0.1 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. As of December 31, 2018 and December 31, 2017, the Company capitalized construction-in-progress costs included in
“Property and Equipment, net” on the Company’s consolidated balance sheets, of $6.9 million and $0.1 million, respectively, related
to leasehold improvements, of which $3.7 million was unpaid as of December 31, 2018. As of December 31, 2018 and December 31,
2017, the Company had receivables included in “Prepaid and other current assets” on the Company's consolidated balance sheets, of
$1.2 million and zero, respectively, related to its new office building.
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. Accumulated amortization of intangible assets as of
December 31, 2018 and December 31, 2017, was $1.7 million and $1.5 million, respectively. 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 goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for
impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment
to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test 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 considered not impaired. If the carrying amount of the reporting unit’s goodwill exceeds the
88
implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the carrying amount
of goodwill in the Company’s one reporting unit.
The Company performs an impairment test on its intangible assets 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.
During the year ended December 31, 2018 and 2017, there were no impairment charges recognized related to the acquired intangible
assets.
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. Product 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
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 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 11 for further information regarding the Company’s stock-based compensation assumptions and expenses.
Income Taxes
The provision for income taxes is accounted for using an asset and liability approach, under which 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. The Company does 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 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 for years 1998 through 2017, California tax returns for years through
2017, and Netherlands tax returns for years 2015 through 2017 remain subject to examination by the taxing jurisdictions. The
Company continues to carry a valuation allowance on substantially all of its net deferred tax assets.
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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 and restricted stock units, which are calculated using the
treasury stock method.
For the years ended December 31, 2018, 2017 and 2016, all potentially dilutive securities outstanding have been excluded from the
computation of dilutive weighted average shares outstanding because such securities have an antidilutive impact due to losses
reported.
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, 2018, 2017 and 2016 (in thousands, except per share amounts):
2018
Year Ended December 31,
2017
2016
Numerator for Basic and Diluted:
Net loss used for basic calculation ............................................................................ $
(57,564) $
(60,585) $
(62,906)
Denominator:
Basic weighted average number of shares outstanding .............................................
Effect of dilutive potential shares..............................................................................
Diluted weighted average number of shares outstanding..........................................
131,663
—
131,663
108,221
—
108,221
Net loss per share:
Basic .......................................................................................................................... $
Diluted .......................................................................................................................
(0.44) $
(0.44)
(0.56) $
(0.56)
101,826
—
101,826
(0.62)
(0.62)
The table below presents potential shares 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, 2018, 2017 and 2016 (shares in thousands):
Weighted average number of anti-dilutive potential shares:
Stock options .............................................................................................................
Restricted stock units.................................................................................................
Employee stock purchase plan rights ........................................................................
Total.....................................................................................................................
18,031
1,902
20
19,953
17,373
1,225
21
18,619
15,592
576
43
16,211
2018
Year Ended December 31,
2017
2016
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, 2018 and
December 31, 2017.
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
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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. 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 Note 3 for further information regarding the Company’s valuation of financial instruments.
New Accounting Pronouncements
Recently adopted 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 supersedes most current revenue recognition guidance. The Company adopted the new accounting
standard on January 1, 2018, using the modified retrospective method, and the adoption had no impact on the Company’s consolidated
financial statements.
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 Company adopted this ASU on January 1,
2018, and the adoption had no impact on the Company’s consolidated financial statements.
In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification
Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an
entity to apply modification accounting in Topic 718. The Company adopted this ASU on January 1, 2018, and the adoption did not
have a material impact on the Company’s consolidated financial statements.
In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee
Share-Based Payment Accounting, which simplifies the accounting for share-based payments to nonemployees by aligning it with the
accounting for share-based payments to employees, with certain exceptions. The standard is effective for annual periods beginning
after December 15, 2018, and interim periods thereafter, with early application permitted. The Company early adopted this new
accounting standard on July 1, 2018, and the adoption did not have a material impact on the Company’s consolidated financial
statements.
91
Recently issued accounting pronouncements not yet adopted
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. This ASU will be effective for annual periods beginning after December 15, 2018, and interim periods thereafter,
with early application permitted. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements,
which provides for certain practical expedient when implementing the new leases standard. Companies may apply the practical
expedient either retrospectively or prospectively. The Company will adopt these ASUs on January 1, 2019, using the modified
retrospective approach and will apply the practical expedient prospectively. The Company is currently assessing the future impact of
these ASUs on its consolidated financial statements. The Company anticipates that the Company’s operating lease commitments will
be subject to the new standard. The Company will recognize right-of-use assets and lease liabilities on the Company’s consolidated
balance sheets upon the adoption of these ASUs, which will increase the Company’s total assets and total liabilities. Based on the
lease portfolio as of December 31, 2018, the Company anticipates recording both right-of-use assets and lease liabilities between
approximately $2 million to $3 million on its consolidated balance sheets, and anticipates no material impact to its consolidated
statements of operations. However, the ultimate impact of adopting ASU 2016-02 will depend on the Company’s final evaluation as of
the adoption date. The most significant impact on the Company’s consolidated balance sheets is expected to be the Company’s lease
to office space located in Concord, California, with commencement date of March 2019. 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 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 plans to adopt this ASU on January 1, 2020, using the modified retrospective transition method. The Company is
currently assessing the future impact of this ASU on the Company’s consolidated financial statements.
Note 3. Available-for-sale Securities and Fair Value on Financial Instruments
Available-for-sale Securities
The following is a summary of available-for-sale securities at December 31, 2018 (in thousands):
Money market funds........................................................................... $
United States government agency securities ......................................
Corporate debt securities ....................................................................
Total available-for-sale securities .............................................. $
6,167 $
15,971
73,028
95,166 $
— $
—
2
2 $
— $
(23)
(260)
(283) $
6,167
15,948
72,770
94,885
Amortized Cost
Gross
Unrealized Gain
Gross
Unrealized Loss
Fair Value
December 31, 2018
The following is a summary of available-for-sale securities at December 31, 2017 (in thousands):
Amortized Cost
Gross
Unrealized Gain
Gross
Unrealized Loss
Fair Value
December 31, 2017
Money market funds........................................................................... $
United States government agency securities ......................................
Corporate debt securities ....................................................................
Total available-for-sale securities .............................................. $
3,758 $
11,252
35,858
50,868 $
— $
—
—
— $
— $
(24)
(73)
(97) $
3,758
11,228
35,785
50,771
Available-for-sale securities at December 31, 2018 and 2017, consisted of the following by contractual maturity (in thousands):
One year or less .................................................................................. $
Greater than one year and less than five years ...................................
Total available-for-sale securities .............................................. $
85,227 $
9,939
95,166 $
84,957 $
9,928
94,885 $
38,836 $
12,032
50,868 $
38,781
11,990
50,771
December 31, 2018
December 31, 2017
Amortized Cost
Fair Value
Amortized Cost
Fair Value
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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):
Less than 12 Months
December 31, 2018
12 Months or Greater
Total
Fair Value
Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss
United States government agency
securities ............................................. $
Corporate debt securities........................
Total available-for-sale securities .... $
14,948 $
60,813
75,761 $
(22) $
(231)
(253) $
999 $
9,976
10,975 $
(1) $
(29)
(30) $
15,947 $
70,789
86,736 $
(23)
(260)
(283)
Less than 12 Months
December 31, 2017
12 Months or Greater
Total
Fair Value
Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss
United States government agency
securities ............................................. $
Corporate debt securities........................
Total available-for-sale securities .... $
8,729 $
35,785
44,514 $
(24) $
(73)
(97) $
— $
—
— $
— $
—
— $
8,729 $
35,785
44,514 $
(24)
(73)
(97)
As of December 31, 2018, 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, 2018, 2017 and 2016, 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.
During the years ended December 31, 2018, 2017 and 2016, the Company sold zero, 346,700 and 50,000 shares of Aduro Biotech,
Inc., or Aduro, common stock, respectively, and recognized zero, $3.5 million, and $0.8 million gross realized gains respectively,
which were reclassified out of accumulated other comprehensive income into “Other income, net” on the Company’s consolidated
statements of operations. As of December 31, 2018 and 2017, the Company had no remaining investment in Aduro’s common stock.
The Company did not record any gross realized losses during the years ended December 31, 2018, 2017 and 2016.
Fair Value Disclosures
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:
•
•
•
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, 2018, the Company’s primary pricing 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.
93
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2018 (in
thousands):
Balance sheet
classification
Cash and cash
equivalents
Money market funds ....................................
United States government agency
securities ................................................... Short-term investments
Corporate debt securities.............................. Short-term investments
$
Total financial assets............................
$
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
6,167 $
6,167 $
— $
15,948
72,770
94,885 $
—
—
6,167 $
15,948
72,770
88,718 $
—
—
—
—
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2017 (in
thousands):
Balance sheet
classification
Cash and cash
equivalents
Money market funds
United States government agency
securities ................................................... Short-term investments
Corporate debt securities.............................. Short-term investments
$
Total financial assets............................
$
Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
3,758 $
3,758 $
— $
11,228
35,785
50,771 $
—
—
3,758 $
11,228
35,785
47,013 $
—
—
—
—
The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2018 and 2017.
Note 4. Inventories
Inventories at December 31, 2018 and 2017, consisted of the following (in thousands):
Work-in-process ..................................................................................................................... $
Finished goods........................................................................................................................
Total inventories ............................................................................................................... $
3,075 $
10,464
13,539 $
4,299
10,158
14,457
December 31,
2018
2017
Note 5. Property and Equipment, net
Property and equipment, net at December 31, 2018 and 2017, consisted of the following (in thousands):
Construction-in-progress ........................................................................................................ $
Machinery and equipment ......................................................................................................
Computer equipment and software ........................................................................................
Furniture and fixtures .............................................................................................................
Leasehold improvements........................................................................................................
Consigned equipment .............................................................................................................
Total property and equipment, gross ................................................................................
Accumulated depreciation and amortization..........................................................................
Total property and equipment, net.................................................................................... $
December 31,
2018
2017
6,864 $
1,945
2,915
901
5,715
1,299
19,639
(11,509)
8,130 $
70
2,205
3,446
904
5,698
1,190
13,513
(11,394)
2,119
94
Depreciation and amortization expense related to property and equipment, net was $1.1 million, $1.2 million and $1.1 million for the
years ended December 31, 2018, 2017 and 2016, respectively. The impairment of long-lived assets were zero, zero, and $0.2
million for the years ended December 31, 2018, 2017 and 2016, respectively. As part of the Company’s 2016 review of property and
equipment, an impairment of long-lived assets on the consolidated statement of operations was recorded for construction-in-progress
related to a deposit associated with a terminated agreement.
Note 6. Goodwill and Intangible Assets, net
Goodwill
During the year ended December 31, 2018, the Company did not dispose of or recognize additional goodwill. On August 31, 2018, 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, 2018 (in thousands):
Acquisition-related intangible assets:
Reacquired license - INTERCEPT Asia........................................................ $
Total intangible assets .............................................................................. $
2,017 $
2,017 $
(1,683) $
(1,683) $
334
334
The following is a summary of intangible assets, net at December 31, 2017 (in thousands):
Gross
Carrying Amount
December 31, 2018
Accumulated
Amortization
Net
Carrying Amount
Gross
Carrying Amount
December 31, 2017
Accumulated
Amortization
Net
Carrying Amount
Acquisition-related intangible assets:
Reacquired license - INTERCEPT Asia........................................................ $
Total intangible assets .............................................................................. $
2,017 $
2,017 $
(1,481) $
(1,481) $
536
536
During the years ended December 31, 2018, 2017 and 2016, there were no impairment charges recognized related to the Company’s
intangible assets.
At December 31, 2018, the expected annual amortization expense of the intangible assets, net is $0.2 million for the year ending
December 31, 2019, and $0.1 million for the year ending December 31, 2020.
Note 7. Accrued Liabilities
Accrued liabilities at December 31, 2018 and 2017, consisted of the following (in thousands):
Accrued compensation and related costs ............................................................................... $
Accrued professional services ................................................................................................
Accrued development costs....................................................................................................
Other accrued expenses ..........................................................................................................
Total accrued liabilities..................................................................................................... $
10,765 $
4,544
1,965
2,526
19,800 $
7,372
1,811
794
1,735
11,712
December 31,
2018
2017
95
Note 8. Debt
Debt at December 31, 2018, consisted of the following (in thousands):
Principal
December 31, 2018
Unamortized
Discount
Net Carrying
Value
Loan and Security Agreement ........................................................................... $
Less: debt - current.............................................................................................
Debt - non-current.............................................................................................. $
30,000 $
(7,857)
22,143 $
(130) $
—
(130) $
29,870
(7,857)
22,013
Debt at December 31, 2017, consisted of the following (in thousands):
Loan and Security Agreement ........................................................................... $
Less: debt - current.............................................................................................
Debt - non-current.............................................................................................. $
30,000 $
—
30,000 $
(202) $
—
(202) $
Principal
December 31, 2017
Unamortized
Discount
Total
29,798
—
29,798
Expected future principal and interest payments based on debt balances at December 31, 2018, are expected to be as follows:
Year ended December 31,
Principal
Interest
Total
2019 .............................................................................................................. $
2020 ..............................................................................................................
2021 ..............................................................................................................
2022 ..............................................................................................................
Total ........................................................................................................ $
7,857 $
8,571
8,572
5,000
30,000 $
2,579
1,765
931
2,560
7,835 $
10,436
10,336
9,503
7,560
37,835
Loan and Security Agreement
Prior to December 31, 2016, the Company maintained a five-year loan and security agreement (the “Term Loan Agreement”) with
Oxford Finance LLC (“Oxford”), under which the Company borrowed $20.0 million. The borrowings were set to mature on June 1,
2019, with various interest only periods.
On April 27, 2017, the Term Loan Agreement was amended to include an additional interest-only period under the Term Loan
Agreement. As amended, the Company was required to make interest only payments from May 2017 through December 2017,
followed by eighteen months of equal principal and interest payments thereafter. The Company was also required to make a final
payment equal to 7% of the principal amounts drawn payable on the earlier to occur of maturity or prepayment.
On July 31, 2017 (the “Closing Date”), the Company entered into an amended and restated loan and security agreement (the
“Amended Credit Agreement”) with Oxford, which amended and restated the Term Loan Agreement in its entirety. The Amended
Credit Agreement provided for secured growth capital term loans of up to $40.0 million (the “2017 Term Loans”). All of the
Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V.,
are secured for its borrowings under the Amended Credit Agreement. The 2017 Term Loans were available in two tranches. The first
tranche of $30.0 million (“2017 Term Loan A”) was drawn by the Company on July 31, 2017, with the proceeds used in part to repay
in full all of the outstanding term loans under the Term Loan Agreement of $17.6 million and the final payment of the Term Loan
Agreement of $1.4 million. The availability of the second tranche of $10.0 million (“2017 Term Loan B”) expired on May 14, 2018,
and the Company did not elect to draw the 2017 Term Loan B. The 2017 Term Loan A bears interest at a rate equal to the greater of
(i) 8.01% and (ii) the three-month U.S. LIBOR rate plus 6.72%. The interest rate on the 2017 Term Loan A at December 31, 2018 was
approximately 9.53%. The Company will also be required to make a final payment fee of 8.00% of the principal amounts of the 2017
Term Loan A. The Amended Credit Agreement contains certain nonfinancial covenants, with which the Company was in compliance
at December 31, 2018.
Note 9. Commitments and Contingencies
Operating Leases
The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment and
automobiles 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 2030, with certain of the leases
96
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 and as such, are not included on its consolidated
balance sheets.
Future minimum non-cancelable lease payments under operating leases as of December 31, 2018, were as follows (in thousands):
Year ended December 31,
2019..................................................................................................................................................................... $
2020.....................................................................................................................................................................
2021.....................................................................................................................................................................
2022.....................................................................................................................................................................
2023.....................................................................................................................................................................
Thereafter ............................................................................................................................................................
Total............................................................................................................................................................... $
Lease Payments
3,535
3,027
3,076
2,703
2,611
18,690
33,642
Rent expense for office facilities was $1.0 million, $1.0 million and $0.8 million for the years ended December 31, 2018, 2017 and
2016, respectively.
Purchase Commitments
The Company is party to agreements with certain providers for certain components of the INTERCEPT Blood System. Certain of
these agreements require minimum purchase commitments from the Company. The Company has paid $10.0 million, $6.7 million and
$6.9 million for goods under agreements which are subject to minimum purchase commitments during the years ended December 31,
2018, 2017 and 2016, respectively. As of December 31, 2018, the Company had future minimum purchase commitments under these
agreements of approximately $13.1 million, $3.2 million, $2.5 million, $2.6 million, and $0.1 million for the years ending December
31, 2019, 2020, 2021, 2022, and 2023, respectively.
Note 10. Stockholders’ Equity
Public Offering of Common Stock
In January 2018, the Company issued and sold 14,030,000 shares of the Company’s common stock, par value $0.001 per share, at
$4.10 per share in an underwritten public offering. The proceeds to the Company from this offering were approximately $57.2 million,
net of the underwriting discount and other issuance costs.
Sales Agreement
On May 5, 2016, the Company entered into Amendment No. 2 to the Controlled Equity OfferingSM Sales Agreement (as amended on
May 5, 2016, the “Prior Cantor Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) that provides for the issuance and sale of shares
of the Company’s common stock having an aggregate offering price of up to $132.2 million through Cantor over the term of the
Amended Cantor Agreement. 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.
On August 4, 2017, the Company entered into Amendment No. 3 to the Cantor Agreement (as amended on August 4, 2017, the
“Amended Cantor Agreement”). The Amended Cantor Agreement became effective on January 8, 2018, and provides for the issuance
and sale of shares of the Company’s common stock having an aggregate offering price of up to $70.0 million through Cantor, which
amount includes the $31.4 million of unsold shares of common stock available for sale under the Prior Cantor Agreement immediately
prior to the effectiveness of 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, 2018, 4.2
million shares of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $27.9
million. During the year ended December 31, 2017, 11.0 million shares of the Company’s common stock were sold under the Prior
Cantor Agreement for net proceeds of $30.3 million. At December 31, 2018, the Company had approximately $41.6 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
97
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, 2018, no Series C Junior Participating preferred stock
has been issued. The expiration date of the rights issued under the stockholder rights plan is October 27, 2019.
Note 11. 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. At December 31, 2018,
the Company had 0.8 million 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 and its
subsequent amendments (collectively, the Amended “2008 Plan”). The Amended 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. 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. At December 31, 2018, 20,000
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 fide period of non-employment, as an inducement material to
the individual’s entry into employment with the Company. The terms and conditions of the Inducement Plan are substantially similar
to the Amended 2008 Plan. Effective June 7, 2017, the Company no longer issues shares from the Inducement Plan.
At December 31, 2018, the Company had an aggregate of approximately 22.9 million shares of its common stock subject to
outstanding options or RSUs, or remaining available for future issuance under the Amended 2008 Plan, of which approximately
17.6 million shares and 2.0 million shares were subject to outstanding options and outstanding RSUs, respectively, and approximately
3.3 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 or vesting of RSUs.
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share
amounts):
Balances at December 31, 2017..............................................................................................
Granted ..............................................................................................................................
Exercised ...........................................................................................................................
Forfeited ............................................................................................................................
Expired ..............................................................................................................................
Balances at December 31, 2018..............................................................................................
Number of Options
Outstanding
Weighted Average
Exercise Price per
Share
17,138 $
3,447
(2,195)
(678)
(152)
17,560
4.27
4.78
3.19
4.73
5.93
4.47
98
Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):
Balances at December 31, 2017 ..............................................................................................
Granted (1)...........................................................................................................................
Vested.................................................................................................................................
Forfeited .............................................................................................................................
Balances at December 31, 2018 ..............................................................................................
Number of
Shares
Outstanding
Weighted
Average
Grant Date
Fair Value
per Share
1,256 $
1,420
(521)
(154)
2,001
4.53
4.51
4.45
4.22
4.56
(1)
Includes the number of shares issuable under the performance-based restricted stock unit awards granted during the twelve months ended
December 31, 2018.
The total fair value of RSUs as of their respective vesting dates, for the years ended December 31, 2018, 2017 and 2016, were $2.8
million, $1.0 million and zero, respectively.
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options
exercisable at December 31, 2018, 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, 2018
Stock options outstanding ............................................................
Stock options vested and expected to vest ...................................
Stock options exercisable .............................................................
17,560
17,276
12,336
$
4.47
4.47
4.37
6.3
6.3
5.4
$
14,345
14,179
11,402
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, 2018, 2017 and 2016, was $7.1 million, $0.6 million
and $1.9 million, respectively. The total intrinsic value of exercised stock options is calculated based on the difference between the
exercise price and the quoted market price of the Company’s common stock as of the close of the exercise date.
Stock-based Compensation Expense
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended
December 31, 2018, 2017 and 2016, was as follows (in thousands):
Research and development ................................................................................ $
Selling, general and administrative....................................................................
Total stock-based compensation expense..................................................... $
1,669 $
8,725
10,394 $
1,323 $
8,032
9,355 $
1,091
6,974
8,065
2018
Year Ended December 31,
2017
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 nearly 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, 2018, 2017 and 2016. The Company has also not recorded any stock-based compensation
associated with performance-based stock options during the years ended December 31, 2018, 2017 and 2016.
As of December 31, 2018, the Company expects to recognize the remaining unamortized stock-based compensation expense of $10.3
million and $5.5 million, respectively, related to non-vested stock options and RSUs, net of estimated forfeitures, over an estimated
remaining weighted average period of 2.5 years and 1.8 years, respectively.
99
Valuation Assumptions for Stock-based Compensation
The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock
purchase plan rights. 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.
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2018, 2017
and 2016, was as follows:
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.....................................................................................
2018
6.07
50%
2.72%
0%
0.74
47%
2.34%
0%
Year Ended December 31,
2017
6.12
47%
2.14%
0%
0.92
57%
1.08%
0%
2016
5.85
49%
1.41%
0%
0.76
47%
0.55%
0%
The weighted average grant-date fair value of stock options granted during the years ended December 31, 2018, 2017 and 2016, was
$2.41 per share, $1.98 per share and $2.55 per share, respectively. The weighted average grant-date fair value of employee stock
purchase rights during the years ended December 31, 2018, 2017 and 2016, was $2.29 per share, $1.18 per share and $1.87 per share,
respectively.
Note 12. 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, 2018, 2017 and 2016. During the year ended
December 31, 2018, the Company approved a 401(k) employer match that is effective in 2019. Under the 401(k) match, the Company
will match 50% of the first 6% of each employee’s 401(k) contribution, up to an annual maximum of $5,000. The employer match
will vest immediately.
Note 13. Development and License Agreements
Agreements with Fresenius
Fresenius manufactures and supplies the platelet and plasma systems to the Company under a supply agreement (the “Supply
Agreement”). Fresenius is 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 Supply 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.
100
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 Supply 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.
The Supply Agreement also requires the Company to make certain payments totaling €8.6 million (“Manufacturing and Development
Payments”) to Fresenius. In 2016, the Company paid €3.1 million to Fresenius. In August 2018, the Company entered into an
amendment to the Supply Agreement accelerating the payment for the remaining €5.5 million to August 2019. 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 at that time. The Manufacturing and Development
Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As of December 31,
2018 and 2017, the Company accrued $5.9 million (€5.2 million) and $5.8 million (€4.8 million), respectively, related to the
remaining Manufacturing and Development Payments, which were included in “Manufacturing and development obligations –
current” on the Company’s consolidated balance sheets.
The Supply Agreement also requires the Company to make payments to support certain projects Fresenius has and will perform on
behalf of the Company related to certain R&D activities and manufacturing efficiency activities for which certain assets have been
established in the Company’s consolidated balance sheets. The manufacturing efficiency asset is expensed on a straight line basis over
the life of the Supply Agreement. 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 following table summarizes the
amount of prepaid R&D asset and manufacturing efficiency asset at December 31, 2018 and December 31, 2017 (in thousands).
December 31,
2018
2017
Prepaid R&D asset - current (1)............................................................................................. $
Prepaid R&D asset - non-current (2) .....................................................................................
Manufacturing efficiency asset (2) ........................................................................................
47 $
2,156
1,594
114
2,162
1,839
(2)
(3)
Included in “Other current assets” in the Company's consolidated balance sheets.
Included in “Other assets” in the Company's consolidated balance sheets.
The initial term of the Supply 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 Supply
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 $21.3 million, $18.1 million and $16.1 million relating to the manufacturing of the
Company’s products during the years ended December 31, 2018, 2017 and 2016, respectively. The following table summarizes the
amounts of the Company’s payables to and receivables from Fresenius at December 31, 2018 and December 31, 2017(in thousands).
December 31,
2018
2017
Payables to Fresenius (1) ....................................................................................................... $
Receivables from Fresenius (2) .............................................................................................
7,812 $
1,777
4,687
231
(1)
(2)
Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets.
Included in “Other current assets” in the Company's consolidated balance sheets.
Agreement with BARDA
In June 2016, the Company entered into an agreement with 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 and its subsequent modifications include a base period (the “Base Period”) and options (each,
an “Option Period”) with committed funding of up to $103.2 million for clinical development of the INTERCEPT Blood System for
red blood cells (the “red blood cell system”), and the potential for the exercise by BARDA of subsequent Option Periods that, if
exercised by BARDA and completed, would bring the total funding opportunity to $201.2 million over the five-year contract period. If
exercised by BARDA, subsequent Option Periods 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 is responsible for co-investment of $5.0 million and would be responsible for an additional $9.6 million, if
101
certain Option Periods are 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 exercised Option
Period. BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement
for convenience at any time.
As of December 31, 2018 and 2017, $2.3 million and $1.4 million, respectively, of billed and unbilled amounts were included in
accounts receivable on the Company’s consolidated balance sheets related to BARDA.
Note 14. Income Taxes
U.S and foreign components of consolidated loss before income taxes for the years ended December 31, 2018, 2017 and 2016, was as
follows (in thousands):
Loss before income taxes:
U.S. ............................................................................................................... $
Foreign..........................................................................................................
Loss before income taxes.................................................................................. $
(58,048) $
713
(57,335) $
(57,925) $
1,227
(56,698) $
(63,246)
515
(62,731)
2018
2017
2016
The provision for income taxes for the years ended December 31, 2018, 2017 and 2016, was as follows (in thousands):
2018
2017
2016
Provision for income taxes:
Current:
Foreign.......................................................................................................... $
Federal ..........................................................................................................
State ..............................................................................................................
Total current............................................................................................
Deferred:
Foreign..........................................................................................................
Federal ..........................................................................................................
State ..............................................................................................................
Total deferred..........................................................................................
Provision for income taxes................................................................................. $
225 $
—
—
225
—
3
1
4
229 $
181 $
—
—
181
—
3,659
47
3,706
3,887 $
147
—
—
147
—
28
—
28
175
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, 2018, 2017 and 2016, was as follows (in thousands):
Federal statutory tax........................................................................................... $
Tax Act revaluation of deferred taxes................................................................
Tax Act deemed income inclusion.....................................................................
Federal research credits......................................................................................
State research credits..........................................................................................
Expiration of federal carryovers ........................................................................
Expiration of state carryovers ............................................................................
Change in valuation allowance ..........................................................................
Compensation related items...............................................................................
State taxes ..........................................................................................................
Revision to prior year items...............................................................................
Other ..................................................................................................................
Provision for income taxes................................................................................. $
2018
2017
2016
(12,040) $
—
—
(1,390)
(655)
4,154
1,344
9,913
(361)
(1,141)
—
405
229 $
(19,277) $
81,923
1,083
(1,000)
(628)
—
1,475
(59,462)
1,382
(803)
—
(806)
3,887 $
(21,329)
—
—
(809)
(449)
—
1,193
3,940
484
(990)
17,200
935
175
102
The Tax Cuts and Jobs Act (the “Tax Act”) resulted in a significant revaluation in the Company’s deferred tax balances as of the date
of December 22, 2017, enactment due to the change in the statutory rate. In addition, all of the previously unremitted earnings of
Cerus Europe B.V. were deemed to be distributed as of December 31, 2017, which resulted in a one-time deemed income inclusion.
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, 2018 and 2017, were as follows (in thousands):
Deferred tax assets:
Net operating loss carryforwards ...................................................................................... $
Research and development credit carryforwards ..............................................................
Capitalized research and development..............................................................................
Compensation related items ..............................................................................................
Other..................................................................................................................................
Total deferred tax assets....................................................................................................
Valuation allowance ...............................................................................................................
Net deferred tax assets....................................................................................................... $
125,016 $
26,705
15,293
8,310
4,013
179,337
(179,245)
92 $
117,028
25,061
17,195
7,011
3,116
169,411
(169,332)
79
December 31,
2018
2017
Deferred tax liabilities:
Amortization of goodwill .................................................................................................. $
Total deferred tax liabilities......................................................................................... $
127 $
127 $
111
111
The valuation allowance increased by $9.9 million for the year ended December 31, 2018, compared to the decrease of $59.5 million
and increase of $3.9 million for the years ended December 31, 2017 and 2016, 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 and expected near-term future losses. The
Company expects to maintain a valuation allowance until circumstances change.
For the year ended December 31, 2018, the Company reported pretax net losses 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.
The Company's tax losses and credits are subject to varying carryforward periods. The gross amounts and dates of expiration of the
significant carryforwards are as follows:
Total
Expires
2019-2021
Expires
2022-2028
Expires
2029-2038
Federal losses carryovers ............ $
California loss carryovers ...........
Federal research credits ..............
California research credits ..........
Federal foreign tax credits ..........
571,992 $
59,752
18,631
10,220
610
66,880 $
—
5,269
—
—
171,270 $
—
7,626
—
610
No
Expiration
60,257
—
—
10,220
—
273,585 $
59,752
5,736
—
—
The Company’s ability to utilize net operating loss and research and development credit carryforwards is limited by (a) its ability to
generate future taxable income, (b) varying apportionment and allocation rules including new provisions as part of the Tax Act, and
(c) 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.
103
The following is a tabular reconciliation of the total amounts of unrecognized tax benefits (in thousands):
December 31,
2018
December 31,
2017
Unrecognized tax benefits at beginning of period.................................................................. $
Decreases related to expired carryforwards ......................................................................
Increases related to prior year tax positions ......................................................................
Increases related to current year tax positions ..................................................................
Unrecognized tax benefits at end of period ............................................................................ $
11,062 $
(401)
—
402
11,063 $
10,836
—
19
207
11,062
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.
Note 15. 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 R&D 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,
during the years ended December 31, 2018, 2017 and 2016 (in percentages):
Établissement Français du Sang.........................................................................
Advanced Technology Company K.S.C............................................................
* Represents an amount less than 10% of product revenue.
2018
38%
*
Year Ended December 31,
2017
22%
*
2016
*
12%
Revenues by geographical location were based on the location of the customer during the years ended December 31, 2018, 2017 and
2016, and was as follows (in thousands):
Product revenue:
France ........................................................................................................... $
United States.................................................................................................
Belgium ........................................................................................................
Kuwait ..........................................................................................................
Other countries .............................................................................................
Total product revenue .............................................................................
Government contract revenue:
United States.................................................................................................
Total government contract revenue ........................................................
Total revenue ..................................................................................... $
2018
Year Ended December 31,
2017
2016
23,043 $
12,563
6,788
883
17,631
60,908
15,143
15,143
76,051 $
9,692 $
6,316
6,263
2,788
18,509
43,568
7,758
7,758
51,326 $
3,485
4,480
6,392
4,415
18,411
37,183
2,092
2,092
39,275
104
Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31,
2018 and 2017, were as follows (in thousands):
U.S. and territories ................................................................................................................. $
Europe & other .......................................................................................................................
Total long-lived assets ...................................................................................................... $
8,252 $
212
8,464 $
2,443
212
2,655
December 31,
2018
2017
Note 16. Quarterly Financial Information (Unaudited)
The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2018 and 2017 (in
thousands except per share amounts):
Product revenue.................................................................................. $
Gross profit on product revenue.........................................................
Government contract revenue ............................................................
Net loss...............................................................................................
Net loss per share:
Three Months Ended
March 31,
2018
June 30,
2018
September 30,
2018
December 31,
2018
13,564 $
6,234
3,455
(13,885)
15,420 $
7,700
4,047
(13,282)
15,399 $
7,257
3,928
(14,192)
16,525
8,083
3,713
(16,205)
Basic..............................................................................................
Diluted ..........................................................................................
(0.11)
(0.11)
(0.10)
(0.10)
(0.11)
(0.11)
(0.12)
(0.12)
Product revenue.................................................................................. $
Gross profit on product revenue.........................................................
Government contract revenue ............................................................
Net loss...............................................................................................
Net loss per share:
Three Months Ended
March 31,
2017
June 30,
2017
September 30,
2017
December 31,
2017
7,006 $
3,312
1,428
(18,598)
9,525 $
5,165
1,667
(17,083)
10,797 $
5,449
2,285
(13,418)
16,240
7,111
2,378
(11,486)
Basic..............................................................................................
Diluted ..........................................................................................
(0.18)
(0.18)
(0.16)
(0.16)
(0.12)
(0.12)
(0.10)
(0.10)
105
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 26th day of
February, 2019.
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/ ERIC H. BJERKHOLT
Eric H. Bjerkholt
/s/ LAURENCE M. CORASH, M.D.
Laurence M. Corash, M.D.
/s/ TIMOTHY L. MOORE
Timothy L. Moore
/s/ GAIL SCHULZE
Gail Schulze
/s/ FRANK WITNEY, PH.D.
Frank Witney, Ph.D.
President, Chief Executive
Officer and Director
(Principal Executive Officer)
Vice President, Finance and
Chief Financial Officer
(Principal Financial Officer)
Chairman of the Board of Directors
February 26, 2019
February 26, 2019
February 26, 2019
Director
February 26, 2019
Director
Director
Director
Director
Director
February 26, 2019
February 26, 2019
February 26, 2019
February 26, 2019
February 26, 2019
106
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: February 26, 2019
/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: February 26, 2019
/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, 2018, 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 26th day of February, 2019.
/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, Device Development
and Manufacturing
Carol Moore
Senior Vice President, Regulatory
Affairs and Quality
William F. Moore
Senior Vice President, Manufacturing
Operations and Supply Chain
Nina Mufti
Vice President, Development
Lori L. Roll
Vice President, Administration
and Corporate Secretary
Yasmin Singh
Vice President, Program and
Portfolio Management
(middle row) R. Benjamin, Y. Singh, W. Moore, S. Margerum
(bottom row) K. Green, L. Roll, V. Jayaraman, C. Menard (Not pictured)
Board of Directors
Daniel N. Swisher, Jr.
Chair of the Board,
President and Chief Operations
Officer, Jazz Pharmaceuticals, plc.
Eric H. Bjerkholt
Chief Financial Officer
Aimmune Therapeutics, Inc.
Timothy B. Anderson
Former Senior Vice President
Baxter International, Inc.
Laurence M. Corash, M.D.
Chief Scientific Officer
Cerus Corporation
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
1220 Concord Avenue, Suite 600
Concord, California 94520
Telephone: (925) 288-6137
Email: ir@cerus.com
Forward-Looking Statement
William “Obi” Greenman
President and
Chief Executive Officer
Cerus Corporation
Timothy L. Moore
Executive Vice President
Technical Operations
Kite, a Gilead Company
Jami Dover Nachtsheim
Former Vice President of Sales and
Marketing Group
Intel Corporation
Frank R. Witney, Ph.D.
Former President and
Chief Executive Officer
Affymetrix, Inc.
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
Registrar and Transfer Agent
Equiniti Trust Company
1110 Centre Pointe Curve, Suite 101
Mendota Heights, MN 55120
Telephone: (800) 401-1957
Fax: (651) 450-4033
Stock Information
The Company’s common stock
traded on the Nasdaq Stock
Market under the symbol: CERS
Annual Meeting of Stockholders
9:00 a.m., Wednesday, June 5, 2019
at Cerus Corporation
1220 Concord Avenue
Concord, California 94520
This Annual Report contains forward-looking statements concerning our products and prospects, including statements concerning the potential issuance of FDA’s final
guidance document in 2019 and an increased rate of adoption as a result; the timing for a potential submission of a PMA supplement to the FDA for a pathogen-reduced,
extended-storage cryoprecipitate product and the potential approval and future launch thereof, in the U.S., and the potential market opportunity such a product will
have in the U.S.; the potential for additional demand resulting from full adoption by U.S. hospitals; and Cerus’ and its manufacturer’s efforts to scale operations to meet
anticipated growth. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: the uncertain
and time-consuming development and regulatory process, including: (a) the risks related to FDA’s delay in issuing a final guidance document, and (b) that the FDA may
not approve a pathogen-reduced cryoprecipitate product or an extended storage indication; unanticipated difficulties meeting the PMA supplement requirements for a
pathogen-reduced, extended-storage cryoprecipitate product; that the FDA could require additional clinical data to support potential approval of a pathogen-reduced,
extended-storage cryoprecipitate product and that if additional clinical development is required, it will require funding that Cerus does not currently have; risks associated
with commercialization and market acceptance of, and customer demand for, the INTERCEPT treated cryoprecipitate; a delay in increased demand resulting from full adoption
by U.S. hospitals; and Cerus or its manufacturer’s delay or inability to scale its operations for anticipated growth, as well as other risks detailed in Cerus’ most recent filings
with the Securities and Exchange Commission, including Cerus’ Annual Report on Form10-K for the fiscal year ended December 31, 2018, filed with the SEC on February 27,
2019. 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.
Our Mission
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