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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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33-0903395
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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2505 Meridian Parkway, Suite 340
Durham, North Carolina
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27713
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, par value $0.001 per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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the initiation, cost, timing, progress and results of our research and development activities, preclinical studies and future clinical trials;
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our ability to obtain and maintain regulatory approval of our current and future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;
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our ability to obtain funding for our operations;
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our plans to research, develop and commercialize our future product candidates;
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our strategic alliance partners’ election to pursue development and commercialization;
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our ability to attract collaborators with development, regulatory and commercialization expertise;
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our ability to obtain and maintain intellectual property protection for our future product candidates;
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the size and growth potential of the markets for our current and future product candidates, and our ability to serve those markets;
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our ability to successfully commercialize our current and future product candidates;
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the rate and degree of market acceptance of our current and future product candidates;
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our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;
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regulatory developments in the United States and foreign countries;
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the performance of our third-party suppliers and manufacturers;
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the success of competing therapies that are or become available;
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the loss of key scientific or management personnel;
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our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (JOBS Act);
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our use of the proceeds from our public offerings; and
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the accuracy of our estimates regarding expenses, future revenues, capital requirements and need for additional financing.
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Cohort A: allogeneic HCT recipients with localized or asymptomatic AdV infection,
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Cohort B: allogeneic HCT recipients with disseminated AdV disease, and
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Cohort C: autologous HCT recipients, solid organ transplant recipients, and other patients with high-risk or disseminated adenovirus infection.
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Complete Development and Successfully Commercialize Brincidofovir for the Prevention of CMV.
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SUPPRESS, our Phase 3 clinical trial of brincidofovir for the prevention of CMV is actively enrolling in the United States, Canada and Europe. If successful, the data from SUPPRESS will be used to support our U.S. application for Accelerated Approval of brincidofovir for the prevention of CMV infections in allogeneic HCT recipients. We anticipate data from the SUPPRESS trial in early 2016. If approved, we believe that we are well positioned to maximize the commercial potential of brincidofovir as there are currently no approved therapies for prevention of CMV in HCT recipients. We are in discussions with the FDA regarding the study design for our confirmatory Phase 3 study for Traditional Approval of brincidofovir for the prevention of CMV.
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We are also in the process of obtaining scientific and health technology assessment (HTA) advice from the European Medicines Agency on our overall brincidofovir development plan for all indications currently under consideration.
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Complete Development and Successfully Commercialize Brincidofovir for the Treatment of Adenovirus.
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Our AdVise trial is a Phase 3 study of brincidofovir for the treatment of AdV infection in allogeneic HCT recipients and other immunocompromised patients. Patients who have undergone allogeneic HCT are at especially high risk for developing AdV disease due to profound and persistent immunodeficiency. In this susceptible population, the development of AdV infection associated with viremia is much more prevalent, severe and rapidly fatal without treatment. Mortality rates up to 50-80% are reported for HCT recipients with disseminated disease. No product has received regulatory approval for the treatment or prevention of AdV infection.
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Evaluate Additional Patient Populations and Applications for Use of Brincidofovir.
In addition to our initial development program focusing on CMV prevention in hematopoietic cell transplant recipients and treatment of adenovirus infections, we are evaluating other patient populations and applications for potential future treatment opportunities with brincidofovir.
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Additional patient populations.
We intend to evaluate brincidofovir in other immunocompromised patient populations. Beyond the transplant population, patients may be susceptible to multiple dsDNA viral diseases due to congenital or medically-induced immune deficiencies including those secondary to biologics therapy for autoimmune and other disorders. Through our Expanded Access Program, hundreds of patients have received brincidofovir for the treatment of a variety of life-threatening viral diseases.
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Additional viral indications.
Brincidofovir has shown activity
in vitro
against the five families of dsDNA viruses that cause disease in humans. We intend to evaluate brincidofovir for the treatment of patients with various other dsDNA virus induced diseases. This process has begun with the collection of secondary endpoint data in our SUPPRESS trial and may continue with more virus-specific clinical trials in the future.
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Work with BARDA to Advance Our Smallpox Development Program.
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We are currently collaborating with BARDA for the development of brincidofovir as a potential medical countermeasure for smallpox. We have begun the first pivotal efficacy study in rabbits. Data from this study are anticipated in the second half of 2015. Additional data may be required from a second smallpox animal model.
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Discover and Develop Additional Product Candidates to Strengthen our Product Portfolio.
We have an active discovery and preclinical development program focused on identifying and developing new compounds that can be used to treat diseases for which no current therapeutic option exists or which otherwise continue to have high unmet medical need. We intend to leverage our knowledge and experience of nucleoside analogs to advance compounds in the Chimerix Chemical Library through Investigational New Drug (IND)-enabling studies and potential clinical
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oral and intravenous ganciclovir, a drug that is sold by generic manufacturers;
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Valcyte® (valganciclovir), a prodrug of ganciclovir that is marketed by Hoffmann-La Roche Inc. and generic manufacturers;
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Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers; and
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Foscavir® (foscarnet sodium for injection), marketed by Clinigen Group plc and generic manufacturers.
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letermovir, an anti-CMV drug being developed pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck;
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ASP0113 (TransVax), a CMV prevention vaccine, licensed to Astellas Pharma Inc. from Vical Incorporated and in development by Astellas and Vical; and
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patient-specific T-cell therapies directed at antigens of CMV and other dsDNA viruses.
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over 135 patents or patent applications that we own or have in-licensed from academic institutions, related to brincidofovir and CMX157, which represented a slight increase over the number of patents and patent applications in our patent portfolio at the end of fiscal 2014;
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21 patents and patent applications related to our agreement with the University of Michigan regarding our proprietary Chemical Library; and
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59 US and foreign exclusively and jointly owned patents, and 78 U.S., PCT, and foreign applications relating to brincidofovir or CMX157.
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completion of nonclinical laboratory tests, animal studies and formulation studies according to good laboratory practices (GLP), or other applicable regulations;
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submission to the FDA of an application for an IND, which must become effective before human clinical trials may begin;
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performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as current good clinical practices (GCPs), to establish the safety and efficacy of the proposed drug for its intended use;
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submission to the FDA of an NDA for a new drug;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with the FDA’s current good manufacturing practice standards (cGMP), to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;
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potential FDA inspection of the nonclinical and clinical trial sites that generated the data in support of the NDA; and FDA review of the NDA.
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Phase 1. The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.
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Phase 2. The drug is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.
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Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA.
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continue the development of our lead product candidate, brincidofovir, for the prevention of cytomegalovirus (CMV) infection in hematopoietic cell transplant recipients;
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continue the development of brincidofovir for the treatment of adenovirus (AdV) infection;
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seek to obtain regulatory approvals for brincidofovir;
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prepare for the potential commercialization of brincidofovir;
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scale-up manufacturing capabilities to commercialize brincidofovir for any indications for which we receive regulatory approval;
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begin outsourcing of the commercial manufacturing of brincidofovir for any indications for which we receive regulatory approval;
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establish an infrastructure for the sales, marketing and distribution of brincidofovir for any indications for which we receive regulatory approval;
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expand our research and development activities and advance our clinical programs;
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maintain, expand and protect our intellectual property portfolio;
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continue our research and development efforts and seek to discover additional product candidates; and
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add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and operations as a public company.
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obtaining favorable results for and advancing the development of brincidofovir, initially for the prevention of CMV in hematopoietic cell transplant (HCT) recipients, including successfully completing Phase 3 clinical development;
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obtaining accelerated approval in the United States for brincidofovir, initially for the prevention of CMV infection in HCT recipients;
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obtaining United States and foreign regulatory approvals for brincidofovir for the treatment of adenovirus infection;
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launching and commercializing brincidofovir, including establishing a sales force and collaborating with third parties;
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achieving broad market acceptance of brincidofovir in the medical community and with third-party payors;
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obtaining traditional approval in the United States for brincidofovir for CMV prevention; and
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generating a pipeline of product candidates which progress to clinical development.
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significantly delay, scale back or discontinue the development or commercialization of our product candidates, including brincidofovir;
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seek corporate partners for brincidofovir or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or
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relinquish or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.
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successful completion of nonclinical studies and successful enrollment and completion of clinical trials;
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receipt of marketing approvals from the FDA and corresponding regulatory authorities outside the United States for our product candidates;
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establishing commercial manufacturing capabilities, either by building such facilities ourselves or making arrangements with third-party manufacturers;
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launching commercial sales of the product, whether alone or in collaboration with others;
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acceptance of the product by patients, the medical community and third-party payors;
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effectively competing with other therapies;
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a continued acceptable safety profile of the product following approval; and
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obtaining, maintaining, enforcing and defending intellectual property rights and claims.
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regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;
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we might be required to change one of our clinical research organizations (CROs) during ongoing clinical programs;
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the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate or subjects may drop out of these clinical trials at a higher rate than we anticipate;
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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
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we might have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;
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regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
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the cost of clinical trials of our product candidates may be greater than we anticipate;
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agency or judicial enforcement actions which impact our clinical trials;
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and
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our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials.
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inability to raise funding necessary to initiate or continue a trial;
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delays in obtaining regulatory approval to commence a trial;
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delays in reaching agreement with the FDA and foreign health authorities on final trial design;
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imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities:
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delays caused by disagreements with existing CROs and/or clinical trial sites;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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delays in obtaining required institutional review board approval at each site;
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delays in recruiting suitable patients to participate in a trial;
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delays in having subjects complete participation in a trial or return for post-treatment follow-up;
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delays caused by subjects dropping out of a trial due to side effects or otherwise;
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clinical sites dropping out of a trial to the detriment of enrollment;
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agency or judicial enforcement actions against us;
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time required to add new clinical sites; and
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delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.
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regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a modified risk evaluation and mitigation strategy (REMS);
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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
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we may be required to change the way the product is administered or to conduct additional clinical studies;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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issue an untitled or warning letter asserting that we are in violation of the law;
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seek an injunction or impose civil or criminal penalties or monetary fines;
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suspend or withdraw regulatory approval;
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suspend any ongoing clinical trials;
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refuse to approve a pending application or supplements to an application submitted by us;
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recall and/or seize product; or
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refuse to allow us to enter into supply contracts, including government contracts.
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the federal healthcare anti-kickback statute which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or 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;
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the federal civil and criminal false claims laws and civil monetary penalties, including civil whistleblower or
qui tam
actions, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government;
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the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which, among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly or willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, clearinghouses and healthcare providers;
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the federal Food, Drug and Cosmetic Act (FDCA) which prohibits, among other things, the adulteration or misbranding of drugs and devices;
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the federal transparency law, enacted as part of the Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act of 2010 (collectively, the Health Care Reform Law), and its implementing regulations, which requires manufacturers of drugs, devices, biologicals and medical supplies to report to the U.S. Department of Health and Human Services information related to payments and other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
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analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by state governmental and non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; and state laws and regulations that require manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities.
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inability to meet our product specifications and quality requirements consistently;
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delay or inability to procure or expand sufficient manufacturing capacity;
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manufacturing and product quality issues related to scale-up of manufacturing;
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costs and validation of new equipment and facilities required for scale-up;
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failure to comply with cGMP and similar foreign standards;
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inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
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termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
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reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms;
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lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;
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operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier;
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carrier disruptions or increased costs that are beyond our control; and
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failure to deliver our products under specified storage conditions and in a timely manner.
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does not devote sufficient time and resources to the development and commercialization of CMX157;
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develops, either alone or with others, products that compete with CMX157;
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fails to gain the requisite regulatory approvals for CMX157;
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does not successfully commercialize CMX157;
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does not conduct its activities in a timely manner;
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terminates its license with us;
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does not effectively pursue and enforce intellectual property rights relating to CMX157; or
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merges with a third-party that wants to terminate the collaboration.
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demonstration of clinical safety and efficacy in our clinical trials;
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relative convenience, ease of administration and acceptance by physicians, patients, pharmacists and health care payors;
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prevalence and severity of any AEs;
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limitations or warnings contained in the FDA-approved label for the relevant product candidate;
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availability of alternative treatments;
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pricing and cost-effectiveness;
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effectiveness of our or any future collaborators’ sales and marketing strategies;
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ability to obtain hospital formulary approval;
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ability to ensure availability for product through appropriate channel manager;
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ability to maintain adequate inventory; and
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ability to obtain and maintain sufficient third-party coverage or reimbursement, which may vary from country to country.
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recruiting and retaining talented people;
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training employees that we recruit;
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establishing compliance standards;
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setting the appropriate system of incentives;
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managing additional headcount; and
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integrating a new business unit into an existing corporate architecture.
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different regulatory requirements for drug approvals in foreign countries;
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reduced protection for intellectual property rights;
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unexpected changes in tariffs, trade barriers and regulatory and labor requirements;
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economic weakness, including inflation, or political instability in particular foreign economies and markets;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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foreign taxes, including withholding of payroll taxes;
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foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
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discover and develop medicines that are superior to other products in the market;
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demonstrate through our clinical trials that our product candidates, including brincidofovir, are differentiated from existing and future therapies;
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attract qualified scientific, product development and commercial personnel;
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obtain and successfully defend and enforce patent and/or other proprietary protection for our medicines and technologies;
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obtain required regulatory approvals;
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successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines; and
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negotiate competitive pricing and reimbursement with third-party payors.
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our research methodology or that of our collaboration partners may be unsuccessful in identifying potential product candidates;
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our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; and
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our collaboration partners may change their development profiles for potential product candidates or abandon a therapeutic area.
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audit and object to any BARDA contract-related costs and fees on grounds that they are not allowable under the FAR, and require us to reimburse all such costs and fees;
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suspend or prevent us for a set period of time from receiving new contracts or extending our existing contract based on violations or suspected violations of laws or regulations;
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claim nonexclusive, nontransferable rights to product manufactured and intellectual property developed under the BARDA contract and may, under certain circumstances, such as circumstances involving public health and safety, license such inventions to third parties without our consent;
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cancel, terminate or suspend our BARDA contract based on violations or suspected violations of laws or regulations;
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terminate our BARDA contract in whole or in part for the convenience of the government for any reason or no reason, including if funds become unavailable to the applicable governmental agency;
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reduce the scope and value of our BARDA contract;
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decline to exercise an option to continue the BARDA contract;
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direct the course of a development program in a manner not chosen by the government contractor;
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require us to perform the option segments even if doing so may cause us to forego or delay the pursuit of other opportunities with greater commercial potential;
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take actions that result in a longer development timeline than expected; and
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change certain terms and conditions in our BARDA contract.
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FAR, and agency-specific regulations supplements to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts and implement federal procurement policy in numerous areas, such as employment practices, protection of the environment, accuracy and retention periods of records, recording and charging of costs, treatment of laboratory animals and human subject research;
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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 Act and the Foreign Corrupt Practices Act;
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export and import control laws and regulations; and
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laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.
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termination of contracts;
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forfeiture of profits;
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suspension of payments;
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fines; and
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suspension or prohibition from conducting business with the U.S. government.
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impairment of our business reputation and significant negative media attention;
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withdrawal of participants from our clinical studies;
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significant costs to defend the related litigation and related litigation;
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distraction of management’s attention from our primary business;
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substantial monetary awards to patients or other claimants;
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inability to commercialize our product candidates, including brincidofovir; and
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decreased demand for our product candidates, if approved for commercial sale.
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results of clinical trials of our product candidates or those of our competitors;
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any delay in filing an application for any of our product candidates and any adverse development or perceived adverse development with respect to regulatory review of that application;
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failure to successfully develop and commercialize our product candidates, including brincidofovir;
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termination of any of our license or collaboration agreements;
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any agency or judicial enforcement actions against us;
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inability to obtain additional funding;
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regulatory or legal developments in the United States and other countries applicable to our product candidates;
|
•
|
adverse regulatory decisions;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
inability to obtain adequate product supply for our product candidates, or the inability to do so at acceptable prices;
|
•
|
introduction of new products, services or technologies by our competitors;
|
•
|
failure to meet or exceed financial projections we provide to the public;
|
•
|
failure to meet or exceed the estimates and projections of the investment community;
|
•
|
changes in the market valuations of similar companies;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;
|
•
|
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
•
|
significant lawsuits (including patent or stockholder litigation), and disputes or other developments relating to proprietary rights (including patents, litigation matters and our ability to obtain patent protection for our technologies);
|
•
|
additions or departures of key scientific or management personnel;
|
•
|
sales of our common stock by us or our stockholders in the future;
|
•
|
trading volume of our common stock;
|
•
|
general economic, industry and market conditions; and
|
•
|
the other factors described in this “Risk Factors” section.
|
•
|
authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors;
|
•
|
allowing the authorized number of our directors to be changed only by resolution of our board of directors;
|
•
|
limiting the removal of directors;
|
•
|
creating a staggered board of directors;
|
•
|
requiring that stockholder actions must be effected at a duly called stockholder meeting and prohibiting stockholder actions by written consent;
|
•
|
eliminating the ability of stockholders to call a special meeting of stockholders; and
|
•
|
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at duly called stockholder meetings.
|
|
Year Ended December 31, 2014
|
||||||
|
High
|
|
Low
|
||||
First Quarter
|
$
|
27.14
|
|
|
$
|
15.54
|
|
Second Quarter
|
$
|
23.26
|
|
|
$
|
14.22
|
|
Third Quarter
|
$
|
30.03
|
|
|
$
|
19.35
|
|
Fourth Quarter
|
$
|
40.86
|
|
|
$
|
29.05
|
|
|
|
|
|
||||
|
Year Ended December 31, 2013
|
||||||
|
High
|
|
Low
|
||||
Second Quarter (beginning April 11, 2013)
|
$
|
25.10
|
|
|
$
|
15.11
|
|
Third Quarter
|
$
|
27.00
|
|
|
$
|
15.31
|
|
Fourth Quarter
|
$
|
22.50
|
|
|
$
|
12.96
|
|
Plan Category
|
Number of
securities to be issued upon exercise of outstanding options, warrants and rights (a) |
|
* Weighted-average
exercise price of outstanding options, warrants and rights (b) |
|
Number of
securities remaining available for issuance under equity compensation plans (excluding securities reflected in column (a)) (c) |
|
||||
Equity compensation plans approved by security holders
|
1,859,970
|
|
|
$
|
15.79
|
|
|
2,092,125
|
|
(1)
|
Equity compensation plans not approved by security holders
|
n/a
|
|
|
n/a
|
|
|
n/a
|
|
|
|
|
|
|
|
|
|
|
||||
Total
|
1,859,970
|
|
|
$
|
15.79
|
|
|
2,092,125
|
|
(1)
|
(1)
|
Of the
2,092,125
shares available for issuance,
944,599
were reserved for issuance under our 2013 Employee Stock Purchase Plan.
|
|
Years Ended December 31,
|
||||||||||||||
Consolidated Statement of Operations Data
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contract revenue
|
$
|
4,040
|
|
|
$
|
4,370
|
|
|
$
|
16,275
|
|
|
$
|
12,046
|
|
Collaboration and licensing revenue
|
—
|
|
|
—
|
|
|
17,445
|
|
|
55
|
|
||||
Total revenues
|
4,040
|
|
|
4,370
|
|
|
33,720
|
|
|
12,101
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development
|
45,379
|
|
|
24,662
|
|
|
30,106
|
|
|
30,108
|
|
||||
General and administrative
|
17,527
|
|
|
8,327
|
|
|
6,397
|
|
|
6,985
|
|
||||
Total operating expenses
|
62,906
|
|
|
32,989
|
|
|
36,503
|
|
|
37,093
|
|
||||
Loss from operations
|
(58,866
|
)
|
|
(28,619
|
)
|
|
(2,783
|
)
|
|
(24,992
|
)
|
||||
Other expense:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense, net
|
(445
|
)
|
|
(1,232
|
)
|
|
(776
|
)
|
|
(212
|
)
|
||||
Fair value adjustments to preferred stock warrant liability
|
—
|
|
|
(6,590
|
)
|
|
(847
|
)
|
|
(385
|
)
|
||||
Loss on disposition of assets
|
(1
|
)
|
|
(4
|
)
|
|
—
|
|
|
—
|
|
||||
Net loss
|
(59,312
|
)
|
|
(36,445
|
)
|
|
(4,406
|
)
|
|
(25,589
|
)
|
||||
Accretion of redeemable convertible preferred stock
|
—
|
|
|
(34,108
|
)
|
|
(4,357
|
)
|
|
(9,565
|
)
|
||||
Net loss attributable to common shareholders
|
$
|
(59,312
|
)
|
|
(70,553
|
)
|
|
(8,763
|
)
|
|
(35,154
|
)
|
|||
Net loss per share, basic and diluted
|
$
|
(1.80
|
)
|
|
$
|
(3.65
|
)
|
|
$
|
(5.75
|
)
|
|
$
|
(23.49
|
)
|
Weighted-average shares outstanding, basic and diluted
|
33,003,714
|
|
|
19,307,422
|
|
|
1,524,628
|
|
|
1,496,262
|
|
|
Years Ended December 31,
|
||||||||||||||
Consolidated Balance Sheet Data
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||
Cash and cash equivalents
|
$
|
128,462
|
|
|
$
|
109,976
|
|
|
$
|
19,906
|
|
|
$
|
13,607
|
|
Short-term investments, available-for-sale (1)
|
106,114
|
|
|
—
|
|
|
9,849
|
|
|
5,918
|
|
||||
Working capital
|
220,390
|
|
|
102,802
|
|
|
23,931
|
|
|
18,010
|
|
||||
Long-term investments (1)
|
52,973
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total assets
|
291,878
|
|
|
113,387
|
|
|
32,031
|
|
|
25,432
|
|
||||
Loan payable, net, current portion (2)
|
4,296
|
|
|
5,573
|
|
|
4,753
|
|
|
160
|
|
||||
Loan payable, net, less current portion (2)
|
—
|
|
|
4,294
|
|
|
9,867
|
|
|
2,441
|
|
||||
Redeemable convertible preferred stock warrant liability
|
—
|
|
|
—
|
|
|
7,512
|
|
|
6,491
|
|
||||
Redeemable convertible preferred stock
|
—
|
|
|
—
|
|
|
107,723
|
|
|
103,366
|
|
||||
Accumulated deficit
|
(222,042
|
)
|
|
(162,730
|
)
|
|
(101,032
|
)
|
|
(93,678
|
)
|
||||
Total stockholders’ equity (deficit)
|
$
|
274,636
|
|
|
$
|
98,539
|
|
|
$
|
(101,031
|
)
|
|
$
|
(93,680
|
)
|
(1)
|
Further details of investments is available in "Notes to Consolidated Financial Statements, Note 1.
Fair Value of Financial Instruments"
in Item 8 of this Annual Report.
|
(2)
|
Loan payable is net of debt discount.
|
•
|
fees paid to consultants and contract research organizations (CROs), including in connection with our preclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;
|
•
|
salaries and related overhead expenses, which include stock option and employee stock purchase program compensation and benefits, for personnel in research and development functions;
|
•
|
payments to third-party manufacturers, which produce, test and package our drug substance and drug product (including continued testing of process validation and stability);
|
•
|
costs related to legal and compliance with regulatory requirements; and
|
•
|
license fees for and milestone payments related to licensed products and technologies.
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Direct research and development expenses
|
$
|
31,401
|
|
|
$
|
13,185
|
|
|
$
|
22,013
|
|
Research and development personnel costs
|
10,741
|
|
|
9,344
|
|
|
5,914
|
|
|||
Indirect research and development expenses
|
3,236
|
|
|
2,134
|
|
|
2,179
|
|
|||
Total research and development expenses
|
$
|
45,379
|
|
|
$
|
24,662
|
|
|
$
|
30,106
|
|
•
|
the uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;
|
•
|
the potential benefits of our candidates over other therapies;
|
•
|
the ability to market, commercialize and achieve market acceptance for any of our product candidates that we are developing or may develop in the future;
|
•
|
the results of ongoing or future clinical trials;
|
•
|
the timing and receipt of any regulatory approvals; and
|
•
|
the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.
|
•
|
manufacturing to produce, test and package our drug substance and drug product for brincidofovir; and
|
•
|
initiation, enrollment, and conduct of SUPPRESS;
|
•
|
initiation, enrollment, and conduct of AdVise; and
|
•
|
initiation, enrollment, and conduct of a kidney transplant trial.
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Income Statement Classification:
|
|
||||||||||
Research and development expense:
|
|
|
|
|
|
|
|
|
|||
Employee
|
$
|
1,085
|
|
|
$
|
1,905
|
|
|
$
|
336
|
|
Non-employee
|
—
|
|
|
67
|
|
|
80
|
|
|||
General and administrative expense:
|
|
|
|
|
|
|
|
|
|||
Employee
|
3,326
|
|
|
1,017
|
|
|
921
|
|
|||
Non-employee
|
—
|
|
|
82
|
|
|
59
|
|
|||
Total stock-based compensation expense
|
$
|
4,411
|
|
|
$
|
3,071
|
|
|
$
|
1,396
|
|
•
|
We have limited operating history to estimate the volatility of our common stock price. We calculate expected volatility based on a blend of company specific historical data and a group of similar publicly traded companies for which the historical information is available. For the purpose of identifying peer companies, we consider characteristics such as industry, length of trading history, similar vesting terms and in-the-money option status. We plan to continue to use the guideline peer group volatility information until the historical volatility of our common stock is relevant to measure expected volatility for future option grants.
|
•
|
Prior to our IPO, we determined the average expected life of stock options based on the simplified method in accordance with SEC Staff Accounting Bulletin Nos. 107 and 110. We expect to use the simplified method until we have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term.
|
•
|
We determine the risk-free interest rate by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant.
|
•
|
The assumed dividend yield is based on our expectation of not paying dividends for the foreseeable future.
|
•
|
We estimate forfeitures based on our historical analysis of actual stock option forfeitures.
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Expected volatility
|
71.81
|
%
|
|
76.40
|
%
|
|
80.55
|
%
|
|||
Expected term (in years)
|
6.0
|
|
|
6.1
|
|
|
6.0
|
|
|||
Weighted-average risk-free interest rate
|
1.92
|
%
|
|
1.49
|
%
|
|
0.86
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
14.00
|
|
|
$
|
2.52
|
|
|
$
|
1.93
|
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Expected volatility
|
68.63
|
%
|
|
79.69
|
%
|
|
81.77
|
%
|
|||
Expected term (in years)
|
5.7
|
|
|
6.2
|
|
|
5.8
|
|
|||
Weighted-average risk-free interest rate
|
1.87
|
%
|
|
1.30
|
%
|
|
0.78
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
14.13
|
|
|
$
|
5.01
|
|
|
$
|
3.48
|
|
|
Years Ended December 31,
|
||||||||
|
2014
|
|
2013
|
|
2012
|
||||
Expected volatility
|
74.24
|
%
|
|
51.22
|
%
|
|
*
|
||
Expected term (in years)
|
0.8
|
|
|
1.3
|
|
|
*
|
||
Weighted-average risk-free interest rate
|
0.09
|
%
|
|
0.25
|
%
|
|
*
|
||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
*
|
||
Weighted-average option value per share
|
$
|
9.93
|
|
|
$
|
4.20
|
|
|
*
|
•
|
external market conditions affecting the biotechnology industry;
|
•
|
trends within the biotechnology industry;
|
•
|
the prices at which we sold shares of preferred stock to third-party investors;
|
•
|
the superior rights and preferences of the preferred stock relative to our common stock at the time of each grant;
|
•
|
our results of operations, financial position, status of our research and development efforts, stage of development and business strategy;
|
•
|
the lack of an active public market for our common and our preferred stock; and
|
•
|
the likelihood of achieving a liquidity event in light of prevailing market conditions, such as an initial public offering or sale of our company.
|
|
Years Ended December 31,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
2014
|
|
2013
|
|
Increase/(Decrease)
|
|||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Contract revenue
|
$
|
4,040
|
|
|
$
|
4,370
|
|
|
$
|
(330
|
)
|
|
(7.6
|
)%
|
Total revenues
|
4,040
|
|
|
4,370
|
|
|
(330
|
)
|
|
(7.6
|
)%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
45,379
|
|
|
24,662
|
|
|
20,717
|
|
|
84.0
|
%
|
|||
General and administrative
|
17,527
|
|
|
8,327
|
|
|
9,200
|
|
|
110.5
|
%
|
|||
Total operating expenses
|
62,906
|
|
|
32,989
|
|
|
29,917
|
|
|
90.7
|
%
|
|||
Loss from operations
|
(58,866
|
)
|
|
(28,619
|
)
|
|
30,247
|
|
|
105.7
|
%
|
|||
Other expenses:
|
|
|
|
|
|
|
|
|||||||
Interest expense, net
|
(445
|
)
|
|
(1,232
|
)
|
|
(787
|
)
|
|
(63.9
|
)%
|
|||
Fair value adjustments to preferred stock warrant liability
|
—
|
|
|
(6,590
|
)
|
|
(6,590
|
)
|
|
(100.0
|
)%
|
|||
Loss on disposition of assets
|
(1
|
)
|
|
(4
|
)
|
|
(3
|
)
|
|
75.0
|
%
|
|||
Net loss
|
$
|
(59,312
|
)
|
|
$
|
(36,445
|
)
|
|
$
|
22,867
|
|
|
62.7
|
%
|
•
|
an increase in clinical trial expenses of $14.9 million primarily related to the ongoing Phase 3 SUPPRESS trial, which was in start-up mode in 2013, and the initiation of our Phase 3 AdVise trial;
|
•
|
an increase in drug manufacturing costs of $1.6 million due to ongoing commercial process validation for brincidofovir and CMX669 manufacturing development;
|
•
|
an increase in animal studies of $1.4 million related to work under the BARDA contract and preclinical CMX669 development; and
|
•
|
an increase in cash compensation expense of $2.3 million due to the addition of 23 employees in 2014, partially offset by the reduction in non-cash share-based compensation of $0.9 million primarily related to the effect of an out of period adjustment in 2014 to properly state additional paid in capital related to RSUs.
|
•
|
an increase of $4.7 million in compensation costs, consisting of an increase in cash compensation expense of $1.9 million primarily related to the addition of 6 new employees in 2014, a $0.6 million one-time severance charge in 2014 for the former CEO, and an increase in non-cash share-based compensation of $2.2 million;
|
•
|
an increase of $3.2 million of commercialization expenses in preparation of the launch of brincidofovir; and
|
•
|
an increase of $0.6 million of external service costs and $0.5 million of insurance and taxes attributable to the growth of business.
|
|
Years Ended December 31,
|
|
Dollar Change
|
|
% Change
|
|||||||||
|
2013
|
|
2012
|
|
Increase/(Decrease)
|
|||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Contract revenue
|
$
|
4,370
|
|
|
$
|
16,275
|
|
|
$
|
(11,905
|
)
|
|
(73.1
|
)%
|
Collaboration and licensing revenue
|
—
|
|
|
17,445
|
|
|
(17,445
|
)
|
|
*
|
|
|||
Total revenues
|
4,370
|
|
|
33,720
|
|
|
(29,350
|
)
|
|
(87
|
)%
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
24,662
|
|
|
30,106
|
|
|
(5,444
|
)
|
|
(18.1
|
)%
|
|||
General and administrative
|
8,327
|
|
|
6,397
|
|
|
1,930
|
|
|
30.2
|
%
|
|||
Total operating expenses
|
32,989
|
|
|
36,503
|
|
|
(3,514
|
)
|
|
(9.6
|
)%
|
|||
Loss from operations
|
(28,619
|
)
|
|
(2,783
|
)
|
|
25,836
|
|
|
*
|
|
|||
Other expenses:
|
|
|
|
|
|
|
|
|||||||
Interest expense, net
|
(1,232
|
)
|
|
(776
|
)
|
|
456
|
|
|
58.8
|
%
|
|||
Fair value adjustments to preferred stock warrant liability
|
(6,590
|
)
|
|
(847
|
)
|
|
5,743
|
|
|
*
|
|
|||
Loss on disposition of assets
|
(4
|
)
|
|
—
|
|
|
4
|
|
|
*
|
|
|||
Net loss
|
$
|
(36,445
|
)
|
|
$
|
(4,406
|
)
|
|
$
|
(32,039
|
)
|
|
727.2
|
%
|
•
|
a decrease in clinical trial expenses of $5.1 million related to the completion of multiple Phase 1 and Phase 2 clinical studies in the year ended
December 31, 2013
, combined with the fact that our activities associated with our Phase 3 SUPPRESS trial were in start-up mode in 2013;
|
•
|
a decrease in consulting fees of $1.4 million as we hired 4 additional employees in 2013;
|
•
|
a decrease in BARDA contracted work of $1.3 million related to drug manufacturing validation and animal studies;
|
•
|
a decrease in license fee expenses of $875,000 due to the payment of fees to University of California, San Diego (UCSD) associated with the exclusive license of CMX157 to Merck in July 2012; and
|
•
|
offset by an increase in compensation expense of $2.0 million due to the addition of 4 employees in 2013 and a full year of compensation for 7 employees who joined in the second half of 2012 and the one-time, non-cash share-based compensation expense of $1.4 million related to the vesting of RSUs upon completion of our IPO.
|
•
|
an increase in non-cash share-based compensation for the one-time expense of $560,000 related to the vesting of RSUs upon the completion of our IPO;
|
•
|
an increase of $489,000 for professional fees associated with the registration and sale of share of our common stock by existing shareholders in October 2013; and
|
•
|
an increase in legal and external service costs attributable to the growth of business and preparations associated with operating as a public company.
|
|
Years Ended December 31,
|
||||||||||
Cash sources and uses:
|
2014
|
|
2013
|
|
2012
|
||||||
Net cash used in operating activities
|
$
|
(47,077
|
)
|
|
$
|
(25,559
|
)
|
|
$
|
(1,876
|
)
|
Net cash (used in) provided by investing activities
|
(159,700
|
)
|
|
9,462
|
|
|
(4,139
|
)
|
|||
Net cash provided by financing activities
|
225,263
|
|
|
106,167
|
|
|
12,314
|
|
|||
Net increase in cash and cash equivalents
|
$
|
18,486
|
|
|
$
|
90,070
|
|
|
$
|
6,299
|
|
•
|
the progress, costs, results and timing of SUPPRESS, and the clinical development of brincidofovir for other potential indications;
|
•
|
the willingness of the FDA to accept SUPPRESS, as well as our other completed and planned clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for the prevention of CMV and for other potential indications;
|
•
|
the willingness of the FDA to accept AdVise, as well as our other completed and planned clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for the treatment of adenovirus infection;
|
•
|
the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;
|
•
|
the ability to continue to receive government funding;
|
•
|
the achievement of milestones under our agreement with ContraVir;
|
•
|
the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;
|
•
|
the ability of our product candidates to progress through clinical development successfully;
|
•
|
our need to expand our research and development activities;
|
•
|
the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;
|
•
|
the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;
|
•
|
our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;
|
•
|
our need and ability to hire additional management and scientific and medical personnel;
|
•
|
the effect of competing technological and market developments;
|
•
|
our need to implement additional internal systems and infrastructure, including financial and reporting systems; and
|
•
|
the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.
|
|
Total
|
|
Less Than 1
Year |
|
1 – 3 Years
|
|
3 – 5 Years
|
|
More Than 5 Years
|
||||||||||
Operating leases (1)
|
$
|
1,695
|
|
|
$
|
541
|
|
|
$
|
1,027
|
|
|
$
|
128
|
|
|
$
|
—
|
|
Loan payable (2)
|
4,688
|
|
|
4,688
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Minimum royalties (3)
|
1,550
|
|
|
—
|
|
|
150
|
|
|
400
|
|
|
1,000
|
|
|||||
Other (4)
|
247
|
|
|
247
|
|
|
|
|
|
|
|
||||||||
Total
|
$
|
8,179
|
|
|
$
|
5,475
|
|
|
$
|
1,177
|
|
|
$
|
528
|
|
|
$
|
1,000
|
|
(1)
|
Consists of our corporate headquarters leases encompassing 21,000 square feet of office space that expire in June 2015 and February 2018, and our laboratory lease encompassing 7,925 square feet that expires in June 2018, both of which are located in Durham, North Carolina.
|
(2)
|
Consists of our loan and security agreement with SVB and MidCap, pursuant to which we have borrowed $15.0 million in principal which bears interest at a rate of 8.25% and is repayable in 2015.
|
(3)
|
Consists of amounts payable under a license agreement with the University of Michigan for certain intellectual property related to the Chimerix Chemical Library.
|
(4)
|
Consists of severance payable to our former CEO.
|
|
Page
|
Report of Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets as of December 31, 2014 and 2013
|
|
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2014, 2013 and 2012
|
|
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Years Ended December 31, 2014, 2013 and 2012
|
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2014, 2013 and 2012
|
|
Notes to Consolidated Financial Statements
|
|
/s/ Ernst & Young LLP
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Revenues:
|
|
|
|
|
|
|
|
|
|||
Contract revenue
|
$
|
4,040
|
|
|
$
|
4,370
|
|
|
$
|
16,275
|
|
Collaboration and licensing revenue
|
—
|
|
|
—
|
|
|
17,445
|
|
|||
Total revenues
|
4,040
|
|
|
4,370
|
|
|
33,720
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
45,379
|
|
|
24,662
|
|
|
30,106
|
|
|||
General and administrative
|
17,527
|
|
|
8,327
|
|
|
6,397
|
|
|||
Total operating expenses
|
62,906
|
|
|
32,989
|
|
|
36,503
|
|
|||
Loss from operations
|
(58,866
|
)
|
|
(28,619
|
)
|
|
(2,783
|
)
|
|||
Other expenses:
|
|
|
|
|
|
|
|
|
|||
Interest expense, net
|
(445
|
)
|
|
(1,232
|
)
|
|
(776
|
)
|
|||
Fair value adjustments to preferred stock warrant liability
|
—
|
|
|
(6,590
|
)
|
|
(847
|
)
|
|||
Loss on disposition of assets
|
(1
|
)
|
|
(4
|
)
|
|
—
|
|
|||
Net loss
|
(59,312
|
)
|
|
(36,445
|
)
|
|
(4,406
|
)
|
|||
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|||
Unrealized gain on investments, net
|
35
|
|
|
2
|
|
|
2
|
|
|||
Comprehensive loss
|
$
|
(59,277
|
)
|
|
$
|
(36,443
|
)
|
|
$
|
(4,404
|
)
|
Net loss
|
$
|
(59,312
|
)
|
|
$
|
(36,445
|
)
|
|
$
|
(4,406
|
)
|
Accretion of redeemable convertible preferred stock
|
—
|
|
|
(34,108
|
)
|
|
(4,357
|
)
|
|||
Net loss attributable to common stockholders
|
$
|
(59,312
|
)
|
|
$
|
(70,553
|
)
|
|
$
|
(8,763
|
)
|
Per share information:
|
|
|
|
|
|
|
|
|
|||
Net loss, basic and diluted
|
$
|
(1.80
|
)
|
|
$
|
(3.65
|
)
|
|
$
|
(5.75
|
)
|
Weighted-average shares outstanding, basic and diluted
|
33,003,714
|
|
|
19,307,422
|
|
|
1,524,628
|
|
|
Redeemable
Convertible
Preferred Stock
|
|
Common
Stock
|
|
Additional
Paid-in Capital
|
|
Accumulated
Other
Comprehensive
Gain (Loss)
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity (Deficit)
|
||||||||||||
Balance, December 31, 2011
|
$
|
103,366
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
(4
|
)
|
|
$
|
(93,678
|
)
|
|
$
|
(93,680
|
)
|
Share-based compensation
|
—
|
|
|
—
|
|
|
1,396
|
|
|
—
|
|
|
—
|
|
|
1,396
|
|
||||||
Exercise of stock options
|
—
|
|
|
1
|
|
|
13
|
|
|
—
|
|
|
—
|
|
|
14
|
|
||||||
Dividends on redeemable preferred stock
|
3,600
|
|
|
—
|
|
|
(1,409
|
)
|
|
—
|
|
|
(2,191
|
)
|
|
(3,600
|
)
|
||||||
Adjustment of redeemable preferred stock to redemption value
|
757
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(757
|
)
|
|
(757
|
)
|
||||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
2
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,406
|
)
|
|
(4,406
|
)
|
||||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,404
|
)
|
||||||
Balance, December 31, 2012
|
107,723
|
|
|
3
|
|
|
—
|
|
|
(2
|
)
|
|
(101,032
|
)
|
|
(101,031
|
)
|
||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
3,071
|
|
|
—
|
|
|
—
|
|
|
3,071
|
|
||||||
Exercise of stock options
|
—
|
|
|
—
|
|
|
1,946
|
|
|
—
|
|
|
—
|
|
|
1,946
|
|
||||||
Dividends on redeemable preferred stock
|
976
|
|
|
—
|
|
|
(349
|
)
|
|
—
|
|
|
(627
|
)
|
|
(976
|
)
|
||||||
Adjustment of redeemable preferred stock to redemption value
|
33,132
|
|
|
—
|
|
|
(8,506
|
)
|
|
—
|
|
|
(24,626
|
)
|
|
(33,132
|
)
|
||||||
Exercise of warrants
|
—
|
|
|
—
|
|
|
1,537
|
|
|
—
|
|
|
—
|
|
|
1,537
|
|
||||||
Issuance of 8,418,000 shares of common stock at $14.00 per share, net
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
net of issuance costs of $10,217,696
|
—
|
|
|
23
|
|
|
107,611
|
|
|
—
|
|
|
—
|
|
|
107,634
|
|
||||||
Conversion of redeemable preferred stock into common stock
|
(141,831
|
)
|
|
—
|
|
|
141,831
|
|
|
—
|
|
|
—
|
|
|
141,831
|
|
||||||
Reclassification of redeemable preferred stock warrant liability to
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
additional paid in capital
|
—
|
|
|
—
|
|
|
14,102
|
|
|
—
|
|
|
—
|
|
|
14,102
|
|
||||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
2
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,445
|
)
|
|
(36,445
|
)
|
||||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,443
|
)
|
||||||
Balance, December 31, 2013
|
—
|
|
|
26
|
|
|
261,243
|
|
|
—
|
|
|
(162,730
|
)
|
|
98,539
|
|
||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
4,411
|
|
|
—
|
|
|
—
|
|
|
4,411
|
|
||||||
Exercise of stock options
|
—
|
|
|
2
|
|
|
4,591
|
|
|
—
|
|
|
—
|
|
|
4,593
|
|
||||||
Exercise of warrants
|
—
|
|
|
—
|
|
|
6
|
|
|
—
|
|
|
—
|
|
|
6
|
|
||||||
Employee stock purchase plan purchases
|
—
|
|
|
1
|
|
|
425
|
|
|
—
|
|
|
—
|
|
|
426
|
|
||||||
Issuance of 8,395,000 shares of common stock at $14.22 per share, net
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
of issuance costs of $7,531,172
|
—
|
|
|
8
|
|
|
111,837
|
|
|
—
|
|
|
—
|
|
|
111,845
|
|
||||||
Issuance of 4,197,500 shares of common stock at $29.00 per share, net
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
net of issuance costs of $7,633,815
|
—
|
|
|
4
|
|
|
114,089
|
|
|
—
|
|
|
—
|
|
|
114,093
|
|
||||||
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gain on investments, net
|
—
|
|
|
—
|
|
|
—
|
|
|
35
|
|
|
—
|
|
|
35
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(59,312
|
)
|
|
(59,312
|
)
|
||||||
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
(59,277
|
)
|
|||||||||||
Balance, December 31, 2014
|
$
|
—
|
|
|
$
|
41
|
|
|
$
|
496,602
|
|
|
$
|
35
|
|
|
$
|
(222,042
|
)
|
|
$
|
274,636
|
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(59,312
|
)
|
|
$
|
(36,445
|
)
|
|
$
|
(4,406
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|||
Depreciation of property and equipment
|
283
|
|
|
258
|
|
|
280
|
|
|||
Amortization of debt costs
|
148
|
|
|
248
|
|
|
238
|
|
|||
Amortization of premium/discount on investments
|
1,175
|
|
|
196
|
|
|
84
|
|
|||
Loss on disposition of assets
|
1
|
|
|
4
|
|
|
—
|
|
|||
Share-based compensation
|
4,411
|
|
|
3,071
|
|
|
1,396
|
|
|||
Amortization of deferred lease obligation
|
(19
|
)
|
|
10
|
|
|
—
|
|
|||
Fair value adjustments to preferred stock warrant liability
|
—
|
|
|
6,590
|
|
|
847
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
142
|
|
|
535
|
|
|
3,404
|
|
|||
Prepaid expenses and other assets
|
(108
|
)
|
|
(1,790
|
)
|
|
65
|
|
|||
Accounts payable and accrued liabilities
|
6,202
|
|
|
1,764
|
|
|
(3,784
|
)
|
|||
Net cash used in operating activities
|
(47,077
|
)
|
|
(25,559
|
)
|
|
(1,876
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|||
Purchases of property and equipment
|
(1,018
|
)
|
|
(193
|
)
|
|
(126
|
)
|
|||
Purchases of short-term investments
|
(155,433
|
)
|
|
(1,852
|
)
|
|
(9,907
|
)
|
|||
Purchases of long-term investments
|
(55,337
|
)
|
|
—
|
|
|
—
|
|
|||
Sales of short-term investments
|
3,499
|
|
|
750
|
|
|
—
|
|
|||
Maturities of short-term investments
|
48,589
|
|
|
10,757
|
|
|
5,894
|
|
|||
Net cash (used in) provided by investing activities
|
(159,700
|
)
|
|
9,462
|
|
|
(4,139
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|||
Proceeds from exercise of stock options
|
4,592
|
|
|
1,946
|
|
|
14
|
|
|||
Proceeds from employee stock purchase plan stock purchases
|
426
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from exercise of warrants
|
6
|
|
|
1,537
|
|
|
—
|
|
|||
Proceeds from issuance of debt
|
—
|
|
|
—
|
|
|
15,000
|
|
|||
Proceeds from public offerings, net of offering costs
|
225,939
|
|
|
107,634
|
|
|
—
|
|
|||
Debt discount
|
—
|
|
|
—
|
|
|
(75
|
)
|
|||
Repayments of debt
|
(5,700
|
)
|
|
(4,950
|
)
|
|
(2,601
|
)
|
|||
Payments for stock offering and deferred financing costs
|
—
|
|
|
—
|
|
|
(24
|
)
|
|||
Net cash provided by financing activities
|
225,263
|
|
|
106,167
|
|
|
12,314
|
|
|||
Net increase in cash and cash equivalents
|
18,486
|
|
|
90,070
|
|
|
6,299
|
|
|||
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
|||
Beginning of period
|
109,976
|
|
|
19,906
|
|
|
13,607
|
|
|||
End of period
|
$
|
128,462
|
|
|
$
|
109,976
|
|
|
$
|
19,906
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|||
Cash paid for interest
|
$
|
614
|
|
|
$
|
1,092
|
|
|
$
|
448
|
|
Non-cash acquisition of investment in U.S. corporation
|
$
|
1,545
|
|
|
$
|
—
|
|
|
$
|
—
|
|
•
|
Level 1
— Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
|
•
|
Level 2
— Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3
— Valuations based on inputs that are unobservable and significant to the overall fair value measurement.
|
|
|
|
Fair Value Measurements
|
|
|
||||||||||
|
|
|
December 31, 2014
|
|
|
||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
125,606
|
|
|
$
|
125,606
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Certificates of deposit
|
480
|
|
|
—
|
|
|
480
|
|
|
—
|
|
||||
Total cash equivalents
|
126,086
|
|
|
125,606
|
|
|
480
|
|
|
—
|
|
||||
Short-term investments
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
16,981
|
|
|
—
|
|
|
16,981
|
|
|
—
|
|
||||
Corporate bonds
|
69,892
|
|
|
—
|
|
|
69,892
|
|
|
—
|
|
||||
Commercial paper
|
11,240
|
|
|
—
|
|
|
11,240
|
|
|
—
|
|
||||
U.S. Treasury securities
|
8,000
|
|
|
8,000
|
|
|
—
|
|
|
—
|
|
||||
Total short-term investments
|
106,114
|
|
|
8,000
|
|
|
98,114
|
|
|
—
|
|
||||
Long-term investments
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
10,996
|
|
|
—
|
|
|
10,996
|
|
|
—
|
|
||||
U.S. Treasury securities
|
40,197
|
|
|
40,197
|
|
|
—
|
|
|
—
|
|
||||
Preferred stock of U.S. corporation
|
1,781
|
|
|
—
|
|
|
—
|
|
|
1,781
|
|
||||
Total long-term investments
|
52,973
|
|
|
40,197
|
|
|
10,996
|
|
|
1,781
|
|
||||
Total assets
|
$
|
285,173
|
|
|
$
|
173,803
|
|
|
$
|
109,590
|
|
|
$
|
1,781
|
|
|
|
|
Fair Value Measurements
|
|
|
||||||||||
|
|
|
December 31, 2013
|
|
|
||||||||||
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
107,349
|
|
|
$
|
107,349
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total cash equivalents
|
$
|
107,349
|
|
|
$
|
107,349
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Fair Value Measurements
(Level 3)
|
||
Redeemable convertible preferred stock warrant liability:
|
|
|
|
Fair value at January 1, 2012
|
$
|
6,491
|
|
Issuance
|
174
|
|
|
Fair value increase recorded in other expense
|
847
|
|
|
Fair value at December 31, 2012
|
7,512
|
|
|
Fair value increase recorded in other expense
|
6,590
|
|
|
Reclassification of warrant liability to additional paid-in capital
|
(14,102
|
)
|
|
Fair value at December 31, 2013
|
$
|
—
|
|
|
|
||
Preferred stock of U.S. corporation:
|
|
||
Fair value at January 1, 2014
|
$
|
—
|
|
Investment acquired
|
1,545
|
|
|
Fair value increase recorded in other comprehensive loss
|
236
|
|
|
Fair value at December 31, 2014
|
$
|
1,781
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Prepaid research and development expenses
|
$
|
1,685
|
|
|
$
|
2,433
|
|
Interest receivable
|
553
|
|
|
—
|
|
||
Prepaid insurance
|
342
|
|
|
176
|
|
||
Other prepaid expenses and current assets
|
195
|
|
|
176
|
|
||
Total prepaid expenses and other current assets
|
$
|
2,775
|
|
|
$
|
2,785
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Accrued compensation
|
$
|
3,057
|
|
|
$
|
1,779
|
|
Deferred revenue
|
1,545
|
|
|
—
|
|
||
Accrued research and development expenses
|
1,116
|
|
|
350
|
|
||
Other accrued liabilities
|
1,115
|
|
|
291
|
|
||
Total accrued liabilities
|
$
|
6,833
|
|
|
$
|
2,420
|
|
|
Amortized Cost
|
|
Gross Unrealized
Gains |
|
Gross Unrealized
Losses |
|
Estimated
Fair Value |
||||||||
Corporate bonds
|
$
|
69,947
|
|
|
$
|
—
|
|
|
$
|
(56
|
)
|
|
$
|
69,891
|
|
Certificates of deposit
|
28,039
|
|
|
1
|
|
|
(62
|
)
|
|
27,978
|
|
||||
U.S. Treasury securities
|
48,279
|
|
|
—
|
|
|
(82
|
)
|
|
48,197
|
|
||||
Commercial paper
|
11,242
|
|
|
—
|
|
|
(2
|
)
|
|
11,240
|
|
||||
Preferred stock of U.S. corporation
|
$
|
1,545
|
|
|
$
|
236
|
|
|
$
|
—
|
|
|
$
|
1,781
|
|
Total investments
|
$
|
159,052
|
|
|
$
|
237
|
|
|
$
|
(202
|
)
|
|
$
|
159,087
|
|
|
December 31, 2014
|
||
Maturing in one year or less
|
$
|
106,114
|
|
Maturing after one year through two years
|
52,973
|
|
|
Total investments
|
$
|
159,087
|
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Lab equipment
|
$
|
1,049
|
|
|
$
|
873
|
|
Leasehold improvements
|
777
|
|
|
78
|
|
||
Computer equipment
|
512
|
|
|
324
|
|
||
Office furniture and equipment
|
343
|
|
|
222
|
|
||
Property and equipment
|
2,681
|
|
|
1,497
|
|
||
Less accumulated depreciation
|
(1,371
|
)
|
|
(1,159
|
)
|
||
Property and equipment, net of accumulated depreciation
|
$
|
1,310
|
|
|
$
|
338
|
|
Years Ending December 31,
|
Minimal Rental Payment
|
||
2015
|
$
|
541
|
|
2016
|
511
|
|
|
2017
|
516
|
|
|
2018
|
128
|
|
|
Total future minimum rental payments
|
$
|
1,696
|
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||
For exercise of common stock warrants
|
726,601
|
|
|
1,337,845
|
|
For exercise of outstanding common stock options
|
1,859,970
|
|
|
1,946,823
|
|
For future equity awards under the 2013 Equity Incentive Plan
|
1,147,526
|
|
|
1,681,932
|
|
For future purchases under the 2013 Employee Stock Purchase Plan
|
944,599
|
|
|
704,225
|
|
Total shares of common stock reserved for future issuances
|
4,678,696
|
|
|
5,670,825
|
|
|
Employees
|
||||||||||
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Expected volatility
|
71.81
|
%
|
|
76.40
|
%
|
|
80.55
|
%
|
|||
Expected term (in years)
|
6.0
|
|
|
6.1
|
|
|
6.0
|
|
|||
Weighted-average risk-free interest rate
|
1.92
|
%
|
|
1.49
|
%
|
|
0.86
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
14.00
|
|
|
$
|
2.52
|
|
|
$
|
1.93
|
|
|
Non-Employees
|
||||||||||
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Expected volatility
|
68.63
|
%
|
|
79.69
|
%
|
|
81.77
|
%
|
|||
Expected term (in years)
|
5.7
|
|
|
6.2
|
|
|
5.8
|
|
|||
Weighted-average risk-free interest rate
|
1.87
|
%
|
|
1.30
|
%
|
|
0.78
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
Weighted-average fair value per option
|
$
|
14.13
|
|
|
$
|
5.01
|
|
|
$
|
3.48
|
|
|
Number of Options
Outstanding |
|
Weighted-Average
Exercise Price |
|
Weighted-Average
Remaining Contractual Life (in Years) |
||||
Balance, January 1, 2013
|
2,593,423
|
|
|
$
|
2.45
|
|
|
7.36
|
|
Granted
|
292,906
|
|
|
10.62
|
|
|
—
|
|
|
Exercised
|
(801,049
|
)
|
|
2.43
|
|
|
—
|
|
|
Expired or Canceled
|
(2,816
|
)
|
|
1.57
|
|
|
—
|
|
|
Forfeited
|
(135,641
|
)
|
|
4.55
|
|
|
—
|
|
|
Balance, December 31, 2013
|
1,946,823
|
|
|
$
|
3.54
|
|
|
7.03
|
|
Granted
|
1,385,370
|
|
|
21.57
|
|
|
—
|
|
|
Exercised
|
(1,287,883
|
)
|
|
3.57
|
|
|
—
|
|
|
Expired or Canceled
|
—
|
|
|
—
|
|
|
—
|
|
|
Forfeited
|
(184,340
|
)
|
|
15.30
|
|
|
—
|
|
|
Balance, December 31, 2014
|
1,859,970
|
|
|
$
|
15.79
|
|
|
8.46
|
|
Exercisable at December 31, 2014
|
589,141
|
|
|
$
|
9.03
|
|
|
7.17
|
|
Vested or expected to vest at December 31, 2014
|
1,816,056
|
|
|
$
|
15.73
|
|
|
8.45
|
|
|
|
Outstanding
|
|
Exercisable
|
||||||||||||
Range
|
|
Number
|
|
Weighted-Average Remaining Contractual Life (in years)
|
|
Weighted-Average Exercise Price
|
|
Number
|
|
Weighted-Average Exercise Price
|
||||||
$1.42 to 3.71
|
|
395,871
|
|
|
6.0
|
|
2.35
|
|
|
355,017
|
|
|
2.35
|
|
||
3.72 to 15.96
|
|
368,487
|
|
|
8.4
|
|
9.78
|
|
|
49,372
|
|
|
9.84
|
|
||
15.97 to 18.93
|
|
423,572
|
|
|
9.1
|
|
18.67
|
|
|
88,988
|
|
|
18.74
|
|
||
18.94 to 24.00
|
|
362,990
|
|
|
9.3
|
|
22.48
|
|
|
82,514
|
|
|
22.68
|
|
||
24.01 to 36.75
|
|
309,050
|
|
|
9.8
|
|
28.34
|
|
|
13,250
|
|
|
34.88
|
|
||
$1.42 to 36.75
|
|
1,859,970
|
|
|
8.5
|
|
$
|
15.79
|
|
|
589,141
|
|
|
$
|
9.03
|
|
|
Years Ended December 31,
|
||||||
|
2014
|
|
2013
|
||||
Expected volatility
|
74.24
|
%
|
|
51.22
|
%
|
||
Expected term (in years)
|
0.8
|
|
|
1.3
|
|
||
Weighted-average risk-free interest rate
|
0.09
|
%
|
|
0.25
|
%
|
||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
||
Weighted-average option value per share
|
$
|
9.93
|
|
|
$
|
4.20
|
|
|
Number of Restricted
Stock Units Outstanding |
|
Balance, December 31, 2012
|
43,199
|
|
Granted
|
59,348
|
|
Share issuance
|
(102,547
|
)
|
Balance, December 31, 2013
|
—
|
|
|
Years Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Income Statement Classification:
|
|
||||||||||
Research and development expense:
|
|
|
|
|
|
|
|
|
|||
Employee
|
$
|
1,085
|
|
|
$
|
1,905
|
|
|
$
|
336
|
|
Non-employee
|
—
|
|
|
67
|
|
|
80
|
|
|||
General and administrative expense:
|
|
|
|
|
|
|
|
|
|||
Employee
|
3,326
|
|
|
1,017
|
|
|
921
|
|
|||
Non-employee
|
—
|
|
|
82
|
|
|
59
|
|
|||
Total stock-based compensation expense
|
$
|
4,411
|
|
|
$
|
3,071
|
|
|
$
|
1,396
|
|
|
2014
|
|
2013
|
|
2012
|
|||||||||||||||
|
Amount
|
|
% of Pretax
Earnings |
|
Amount
|
|
% of Pretax
Earnings |
|
Amount
|
|
% of Pretax
Earnings |
|||||||||
Income tax benefit at statutory rate
|
$
|
(20,166
|
)
|
|
34.0
|
%
|
|
$
|
(12,392
|
)
|
|
34.0
|
%
|
|
$
|
(1,499
|
)
|
|
34.0
|
%
|
State income taxes
|
(1,343
|
)
|
|
2.3
|
%
|
|
(852
|
)
|
|
2.3
|
%
|
|
(100
|
)
|
|
2.3
|
%
|
|||
Research and development credits
|
(2,577
|
)
|
|
4.3
|
%
|
|
(2,265.0
|
)
|
|
6.2
|
%
|
|
—
|
|
|
—
|
%
|
|||
Permanent items
|
1,525
|
|
|
(2.6
|
)%
|
|
3,060
|
|
|
(8.4
|
)%
|
|
868
|
|
|
(19.7
|
)%
|
|||
Provision to return adjustments
|
64
|
|
|
(0.1
|
)%
|
|
320
|
|
|
(0.9
|
)%
|
|
2
|
|
|
—
|
%
|
|||
Effect of change in state tax rate
|
2
|
|
|
—
|
%
|
|
(1
|
)
|
|
—
|
%
|
|
609
|
|
|
(13.9
|
)%
|
|||
Increase in unrecognized tax benefits
|
425
|
|
|
(0.7
|
)%
|
|
566.0
|
|
|
(1.5
|
)%
|
|
—
|
|
|
—
|
%
|
|||
Change in valuation allowance
|
22,070
|
|
|
(37.2
|
)%
|
|
11,564
|
|
|
(31.7
|
)%
|
|
120
|
|
|
(2.7
|
)%
|
|||
Net benefit
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
$
|
—
|
|
|
—
|
%
|
|
December 31,
|
||||||
|
2014
|
|
2013
|
||||
Deferred tax assets:
|
|
|
|
|
|
||
Net operating loss carryforwards
|
$
|
59,312
|
|
|
$
|
40,721
|
|
Research and development expenses
|
405
|
|
|
127
|
|
||
Capitalized Section 174 expenses
|
57
|
|
|
69
|
|
||
Research and development credits
|
4,572
|
|
|
2,640
|
|
||
Accrued bonuses
|
1,066
|
|
|
405
|
|
||
Share-based compensation
|
1,045
|
|
|
267
|
|
||
Other
|
135
|
|
|
230
|
|
||
Total gross deferred tax assets
|
66,592
|
|
|
44,459
|
|
||
Valuation allowance
|
(66,475
|
)
|
|
(44,405
|
)
|
||
Total deferred tax assets
|
117
|
|
|
54
|
|
||
Deferred tax liabilities:
|
|
|
|
|
|
||
Other
|
(117
|
)
|
|
(54
|
)
|
||
Total deferred tax liabilities
|
(117
|
)
|
|
(54
|
)
|
||
Total deferred tax assets and liabilities, net
|
$
|
—
|
|
|
$
|
—
|
|
Balance at December 31, 2012
|
$
|
207
|
|
Increases related to 2013
|
197
|
|
|
Increases related to prior periods
|
177
|
|
|
Balance at December 31, 2013
|
581
|
|
|
Increases related to 2014
|
425
|
|
|
Increases related to prior periods
|
—
|
|
|
Balance at December 31, 2014
|
$
|
1,006
|
|
|
2014 Quarters
|
||||||||||||||
|
Fourth
|
|
Third
|
|
Second
|
|
First
|
||||||||
Total revenues
|
$
|
1,156
|
|
|
$
|
1,185
|
|
|
$
|
919
|
|
|
$
|
780
|
|
Operating loss
|
(20,226
|
)
|
|
(16,860
|
)
|
|
(11,596
|
)
|
|
(10,184
|
)
|
||||
Net loss
|
(20,247
|
)
|
|
(16,951
|
)
|
|
(11,734
|
)
|
|
(10,380
|
)
|
||||
Net loss per common share, basic and diluted
|
$
|
(0.52
|
)
|
|
$
|
(0.47
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(0.39
|
)
|
Weighted-average shares outstanding, basic and diluted
|
39,128,297
|
|
|
35,845,792
|
|
|
30,111,380
|
|
|
26,762,264
|
|
|
2013 Quarters
|
||||||||||||||
|
Fourth
|
|
Third
|
|
Second
|
|
First
|
||||||||
Total revenues
|
$
|
879
|
|
|
$
|
912
|
|
|
$
|
808
|
|
|
$
|
1,771
|
|
Operating loss
|
(7,979
|
)
|
|
(6,436
|
)
|
|
(7,656
|
)
|
|
(6,548
|
)
|
||||
Net loss
|
(8,174
|
)
|
|
(6,706
|
)
|
|
(12,459
|
)
|
|
(9,107
|
)
|
||||
Net loss per common share, basic and diluted
|
$
|
(0.31
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.91
|
)
|
|
$
|
(22.58
|
)
|
Weighted-average shares outstanding, basic and diluted
|
26,416,787
|
|
|
25,866,109
|
|
|
23,067,201
|
|
|
1,534,016
|
|
i.
|
pertain to the maintenance of records, that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
ii.
|
provide reasonable assurance that transactions are recorded as necessary to permit preparations of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
iii.
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
|
Exhibit
Number
|
|
Description of Document
|
3.1
(1)
|
|
Amended and Restated Certificate of Incorporation of the Registrant.
|
3.2
(1)
|
|
Amended and Restated Bylaws of the Registrant.
|
4.1
(1)
|
|
Form of Common Stock Certificate of the Registrant.
|
4.2
(1)
|
|
Form of Warrant to Purchase Stock issued to participants in the Registrant's Series F Preferred Stock financing dated February 7, 2011.
|
4.3
(1)
|
|
Amended and Restated Investor Rights Agreement dated February 7, 2011 by and among the Registrant and certain of its stockholders.
|
4.4
(2)
|
|
Amendment to Amended and Restated Investor Rights Agreement dated October 29, 2014 by and among the Registrant and certain of its stockholders.
|
10.1+
(1)
|
|
Form of Indemnity Agreement by and between the Registrant and its directors and officers.
|
10.2+
(1)
|
|
Chimerix, Inc. 2002 Equity Incentive Plan and Form of Stock Option Agreement, Notice of Exercise and Form of Stock Option Grant Notice thereunder.
|
10.3+
(1)
|
|
Chimerix, Inc. 2012 Equity Incentive Plan and Form of Stock Option Agreement, Notice of Exercise and Form of Stock Option Grant Notice and Form of Restricted Stock Unit Award Agreement and Form of Restricted Stock Unit Award Grant Notice thereunder.
|
10.4+
(1)
|
|
Form of Stock Option Agreement, Notice of Exercise and Form of Stock Option Grant Notice.
|
10.5+
(3)
|
|
Chimerix, Inc. 2013 Equity Incentive Plan, as amended.
|
10.6+
(1)
|
|
Chimerix, Inc. 2013 Employee Stock Purchase Plan.
|
10.7+
|
|
Chimerix, Inc. Non-Employee Director Compensation Policy.
|
10.8+
|
|
Chimerix, Inc. Officer Change in Control Severance Benefit Plan, as amended.
|
10.9+
(1)
|
|
Employment Offer Letter to Timothy W. Trost dated March 16, 2011.
|
10.10+
(1)
|
|
Employment Offer Letter to M. Michelle Berrey, M.D., M.P.H. dated November 7, 2012.
|
10.11+
(1)
|
|
Employment Offer Letter to Michael D. Rogers, Ph.D. dated March 4, 2013.
|
10.12+
(8)
|
|
Employment Offer Letter to Linda M. Richardson dated December 13, 2013
|
10.13
(4)
|
|
Employment Offer Letter to William Garret Nichols, M.D., M.S., dated August 19, 2014.
|
10.14+
(1)
|
|
Directorship Offer Letter to Ernest Mario, Ph.D. dated January 31, 2013.
|
10.15
(5)
|
|
Directorship Offer Letter to Lisa Ricciardi dated March 27, 2014.
|
10.16+
|
|
Directorship Offer Letter to James M. Daly dated June 6, 2014.
|
10.17+
|
|
Directorship Offer Letter to Catherine L. Gilliss dated June 13, 2014.
|
10.18+
|
|
Directorship Offer Letter to Patrick Machado dated May 30, 2014.
|
10.19+
|
|
Directorship Offer Letter to Ronald C. Renaud, Jr. dated December 12, 2014.
|
10.20
(1)
|
|
Office Lease by and between the Registrant and ACP 2505 Meridian LLC dated September 1, 2007, as amended.
|
10.21
(7)
|
|
Lease Agreement by and between the Registrant and Northwood RTC LLC dated March 10, 2014
|
10.22
(1)
|
|
Deed of Sublease Agreement by and between the Registrant and MDxHealth, Inc. dated March 7, 2011, as amended.
|
10.23
(6)
|
|
Fifth Amendment to Office Lease dated July 2, 2014 by and between the Registrant and AREP Meridian I LLC.
|
10.24*
(1)
|
|
Contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.25*
(9)
|
|
Contract modification No. 14, dated May 30, 2013, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.26
(10)*
|
|
Contract modification No. 15, dated August 28, 2013, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.27
(10)*
|
|
Contract modification No. 16, dated December 10, 2013, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.28
(5)
|
|
Contract modification No. 17, dated April 14, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.29
|
|
Contract modification No. 18, dated May 6, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.30
(6)*
|
|
Contract modification No. 19, dated August 27, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.31
(6)
|
|
Contract modification No. 20, dated October 27, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.32 **
|
|
Contract modification No. 21, dated November 7, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.33
|
|
Contract modification No. 22, dated December 11, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.34
|
|
Contract modification No. 23, dated December 22, 2014, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.35
|
|
Contract modification No. 24, dated February 19, 2015, to the contract by and between the Registrant and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services dated February 16, 2011, as amended.
|
10.36*
(1)
|
|
License Agreement by and between the Registrant and The Regents of the University of California dated May 13, 2002, as amended.
|
10.37
(1)
|
|
Loan and Security Agreement by and among the Registrant, Midcap Financial SBIC, LP and Silicon Valley Bank dated January 27, 2012, as amended.
|
10.38
|
|
First Loan Modification Agreement, dated December 18, 2013, to the Loan and Security Agreement by and among the Registrant, Midcap Financial SBIC, LP and Silicon Valley Bank dated January 27, 2012, as amended.
|
10.39
(5)
|
|
Severance Agreement and Release by and between the Registrant and Kenneth I. Moch dated May 5, 2014.
|
10.40
(6)
|
|
Amendment No. 1 to Severance Agreement and Release by and between the Registrant and Kenneth I. Moch dated July 1, 2014.
|
23.1
|
|
Consent of Ernst & Young LLP, an Independent Registered Public Accounting Firm.
|
24.1
|
|
Power of Attorney. Reference is made to the signature page hereto.
|
31.1
|
|
Certification of Principal Executive Officer, pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
31.2
|
|
Certification of Principal Financial Officer, pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
32.1
|
|
Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
|
|
Certification of Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted 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.
|
101.LAB***
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE***
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
+
|
|
Indicates management contract or compensatory plan.
|
|
|
|
*
|
|
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
**
|
|
Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
|
***
|
|
In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Annual Report on Form 10-K is furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of the section, and shall not be part of any registration statement or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
|
(1)
|
|
Incorporated by reference to Chimerix, Inc.’s Registration Statement on Form S-1 (No. 333-187145), as amended.
|
(2)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on October 29, 2014.
|
(3)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on June 23, 2014.
|
(4)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on September 4, 2014.
|
(5)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 9, 2014.
|
(6)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 7, 2014.
|
(7)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on March 14, 2014.
|
(8)
|
|
Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on December 18, 2013.
|
(9)
|
|
Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 14, 2013.
|
(10)
|
|
Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on March 7, 2015.
|
|
|
|
Chimerix, Inc.
|
||
|
|
|
|
||
Date:
|
March 6, 2015
|
|
By:
|
|
/s/ M. Michelle Berrey
|
|
|
|
|
|
M. Michelle Berrey, MD, MPH
|
|
|
|
|
|
President & Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ M. Michelle Berrey
|
|
President, Chief Executive Officer and Director
|
|
March 6, 2015
|
M. Michelle Berrey, MD, MPH
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Timothy W. Trost
|
|
Senior Vice President, Chief Financial Officer
|
|
March 6, 2015
|
Timothy W. Trost
|
|
and Corporate Secretary (Principal Financial and
|
|
|
|
|
Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Ernest Mario
|
|
|
|
|
Ernest Mario, PhD
|
|
Chairman of the Board of Directors
|
|
March 6, 2015
|
|
|
|
|
|
/s/ James M. Daly
|
|
|
|
|
James M. Daly
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ Martha J. Demski
|
|
|
|
|
Martha J. Demski
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ Catherine L. Gilliss
|
|
|
|
|
Catherine L. Gilliss, PhD, RN, FAAN
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ John M. Leonard
|
|
|
|
|
John M. Leonard, MD
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ C. Patrick Machado
|
|
|
|
|
C. Patrick Machado
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ James Niedel
|
|
|
|
|
James Niedel, MD, PhD
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ Ronald C. Renaud. Jr
|
|
|
|
|
Ronald C. Renaud, Jr
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ Lisa Ricciardi
|
|
|
|
|
Lisa Ricciardi
|
|
Director
|
|
March 6, 2015
|
|
|
|
|
|
/s/ Timothy J. Wollaeger
|
|
|
|
|
Timothy J. Wollaeger
|
|
Director
|
|
March 6, 2015
|
Re:
|
Member of the Board of Directors of Chimerix, Inc.
|
Re:
|
Member of the Board of Directors of Chimerix, Inc.
|
Re:
|
Member of the Board of Directors of Chimerix, Inc.
|
Re:
|
Member of the Board of Directors of Chimerix, Inc.
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0019
|
PAGE OF
|
||||||
2
|
22
|
|||||||
NAME OF OFFEROR OR CONTACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
Approvals for any clinical trials/studies and any required approved OLAW Assurances and IIA approvals from OLAW for any non clinical animal studies.
2. The incorporation of the attached Statement of Work (SOW) changes in the paragraph above also result in the incorporation of the attached changes into the contract into WBS Milestones/Deliverables and Technical Deliverables and Contract Milestones and Go/No Go Decision Gates dated 27 October 2014 under Article F.2. Deliverables.
3. The total amount, scope and period of performance of Option 2/CLIN 0003 remains unchanged. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount scope and period of performance of all unexercised Option CLINs under the contract remain unchanged.
B. This is a no cost bilateral modification. All other terms and conditions contract number HHS0100201100013C remain unchanged.
Period of Performance: 02/16/2011 to 11/30/2015
|
|
|
|
|
1.
|
PREAMBLE
|
I.
|
[
…***…
]
|
II.
|
[
…***…
]
|
III.
|
[
…***…
]
|
IV.
|
[
…***…
]
|
V.
|
[
…***…
]
|
2.
|
PHASE I: [
…***…
]
|
2.1
|
Program Management
|
2.1.1
|
The overall management, integration and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities;
|
2.1.2
|
A Principal Investigator (PI) responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.
|
2.1.3
|
Project Manager(s) with responsibility for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and program management; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.
|
2.1.4
|
A BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer.
|
2.1.5
|
Administrative and legal staff to provide development of compliant subcontracts, consulting, and other legal agreements, and ensure timely acquisition of all proprietary rights, including IP rights, and reporting all inventions made in the performance of the project.
|
2.1.6
|
Administrative staff with responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors.
|
2.1.7
|
Contract Review Meetings.
|
2.1.7.1
|
The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting and Project Officers. Such meetings may include, but are not limited to, meeting of the Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with technical consultants to discuss technical data provided by the Contractor.
|
2.1.7.2
|
The Contractor shall participate in teleconferences every two weeks between the Contractor and subcontractors and BARDA to review technical progress. Teleconferences or additional face-to-face meetings shall be more frequent at the request of BARDA.
|
2.1.8
|
Integrated Master Schedule
|
2.1.8.1
|
Within 30 calendar days of the effective date of the contract, the Contractor shall submit a first draft of an updated Integrated Master Schedule in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for review and comment. The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract. Contractor shall include the key milestones and Go/No Go decision gates. The IMS for the period of performance will be mutually agreed upon at the PMBR
|
2.1.9
|
Integrated Master Plan
|
2.1.9.1
|
Work Breakdown Structure: The Contractor shall utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor shall expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting. The CWBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task.
|
2.1.9.2
|
GO/NO-GO Decision Gates: The Integrated Master Plan outlines key milestones with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions.
|
2.1.9.3
|
Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract. The Seven Principles are:
|
I.
|
Plan all work scope for the program to completion.
|
II.
|
Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.
|
III.
|
Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline.
|
IV.
|
Use actual cost incurred and recorded in accomplishing the work performed.
|
V.
|
Objectively assess accomplishments at the work performance level.
|
VI.
|
Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.
|
VII.
|
Use earned value information in the company’s management processes.
|
2.1.10
|
Decision Gate Reporting: On completion of a stage of the product development, as defined in the agreed upon Integrated Master Schedule and Integrated Master Plan, the Contractor shall prepare and submit to the Project Officer and the Contracting Officer a Decision Gate Report that contains (i) sufficient detail, documentation and analysis to support successful completion of the stage according to the predetermined qualitative and quantitative criteria that were established for Go/No Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to the next stage of product development.
|
2.1.11
|
Risk Management Plan: The Contractor shall develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant WBS elements where appropriate. Updates to this plan shall be included every three months (quarterly) in the monthly Project Status Report.
|
2.1.12
|
Performance Measurement Baseline Review (PMBR): The Contractor shall submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as
FOLLOWS
:
|
I.
|
Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks
|
II.
|
Confirm the integrity of the Performance Measurement Baseline (PMB)
|
III.
|
Foster the use of EVM as a means of communication
|
IV.
|
Provide confidence in the validity of Contractor reporting
|
V.
|
Identify risks associated with the PMB
|
VI.
|
Present any revised PMBs for mutual agreement
|
VII.
|
Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).
|
VIII.
|
Present the Risk Management Plan
|
2.1.13
|
Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IMS and timelines. This report shall include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.
|
2.1.14
|
Monthly and Annual Reports: The Contractor shall deliver Project Status Reports on a monthly basis. The reports shall address the items below cross referenced to the WBS, SOW, IMS, and EVM:
|
I.
|
Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory;
|
II.
|
Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps
|
III.
|
Updated IMS;
|
IV.
|
Updated EVM;
|
V.
|
Updated Risk Management Plan (Every 3 months);
|
VI.
|
Three month rolling forecast of planned activities;
|
VII.
|
Progress of regulatory submissions;
|
VIII.
|
Estimated and actual expenses;
|
2.1.15
|
Data Management: The Contractor shall develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all contract data;
|
2.1.15.1
|
Provide for the statistical design and analysis of data resulting from the research;
|
2.1.15.2
|
Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request.
|
2.2
|
Non-Clinical Toxicology
|
2.2.1
|
N/A (no scope)
|
2.3
|
Non-Clinical
|
2.3.1
|
Develop and validate [
…***…
] to lower [
…***…
].
|
2.3.2
|
[
…***…
]: Conduct [
…***…
] studies including [
…***…
] studies, [
…***…
], and [
…***…
] studies in [
…***…
].
|
2.3.3
|
[
…***…
]
|
2.3.3.1
|
Conduct [
…***…
] study in [
…***…
].
|
2.3.3.2
|
Conduct [
…***…
] studies including [
…***…
] studies, [
…***…
] studies including [
…***…
] for CMX-001 and [
…***…
] in [
…***…
].
|
2.3.4
|
Use of [
…***…
] as a CMX-001 Surrogate in [
…***…
] Studies.
|
2.3.4.1
|
Dose [
…***…
] with [
…***…
] to identify the concentration of the [
…***…
] in [
…***…
] associated with [
…***…
] of [
…***…
].
|
2.3.5
|
Scaling of [
…***…
] to [
…***…
] by conducting studies with [
…***…
] to determine [
…***…
] in [
…***…
].
|
2.3.6
|
[
…***…
] determination of CMX001, [
…***…
] and [
…***…
] in the [
…***…
].
|
2.3.7
|
Conduct [
…***…
] experiments to demonstrate [
…***…
] following effective [
…***…
] prior to [
…***…
].
|
2.3.8
|
Conduct studies to optimize [
…***…
] in [
…***…
].
|
2.3.9
|
Conduct CMX001 [
…***…
] study in [
…***…
] at a dose of CMX001 equivalent or less than [
…***…
] with treatment beginning at the [
…***…
]
|
2.4
|
Clinical
|
2.4.1
|
Measurement of [
…***…
] levels in [
…***…
] and correlate the [
…***…
] levels to studies conducted in [
…***…
].
|
2.4.2
|
Conduct expanded access protocol ([
…***…
]).
|
2.4.3
|
Analyze data and provide a Final Report for [
…***…
] evaluation of CMX001 in patients [
…***…
]
|
2.5
|
Regulatory
|
2.5.1
|
Engaging the FDA on a path to support the treatment of smallpox indication with CMX-001
|
2.5.2
|
Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA and/or all other data packages;
|
2.5.3
|
Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final minutes of any informal meeting with the FDA;
|
2.5.4
|
Obtain FDA concurrence on the feasibility of the proposed [
…***…
] with CMX001/[
…***…
]/[
…***…
] in the [
…***…
], including FDA feedback on [
…***…
] and review of data for the first [
…***…
] enrolled in the [
…***…
] sub-study
|
2.5.5
|
Develop and submit a revised [
…***…
] for CMX001 for Treatment of Smallpox, including [
…***…
] for FDA review and comment, and revise the [
…***…
] as requested by FDA
|
2.6
|
CMC
|
2.6.1
|
Validation of the [
…***…
] process: Validation of the process to demonstrate the [
…***…
] of a [
…***…
] of acceptable quality will be performed.
|
2.6.2
|
Validation of the [
…***…
] process to produce [
…***…
]: Validation of the process to demonstrate the [
…***…
] of a [
…***…
] of acceptable quality will be performed.
|
3.
|
PHASE II: [
…***…
]
|
3.1
|
Program Management (consistent with section 2.1)
|
3.1.2
|
Program management scope in BASE year is consistent with program management scope in each option year.
|
3.2
|
Non-Clinical toxicology
|
3.2.11
|
N/A (no scope)
|
3.3
|
Non-Clinical
|
3.3.4
|
Quantify [
…***…
] concentrations in [
…***…
] from [
…***…
].
|
3.3.5
|
Determine [
…***…
] for CMX001 in [
…***…
] in [
…***…
].
|
3.3.6
|
Scaling of [
…***…
] to [
…***…
] - Review with BARDA and FDA the [
…***…
] generated to support scaling between [
…***…
] and [
…***…
] using [
…***…
] as well as comparisons of [
…***…
] in the [
…***…
].
|
3.3.7
|
Determine [
…***…
] for CMX001 in [
…***…
] in [
…***…
].
|
3.3.8
|
Conduct [
…***…
].
|
3.3.9
|
Conduct [
…***…
] and [
…***…
]
|
3.3.10
|
Chimerix will provide [
…***…
] for the [
…***…
] and [
…***…
] conducted under [
…***…
]
|
3.4
|
Clinical
|
3.4.6
|
N/A (No scope)
|
3.5
|
Regulatory
|
3.5.3
|
Engaging the FDA on a path to support the treatment of smallpox indication with CMX001
|
3.5.4
|
Generating all necessary documentation for [
…***…
]. [[
…***…
]]
|
3.5.5
|
Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA (if needed) and/or all other data packages;
|
3.5.6
|
Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to the smallpox program; (ii) final draft minutes of any informal meeting with the FDA relating to the smallpox program.
|
3.6
|
CMC
|
3.6.1
|
N/A (No scope)
|
4.
|
PHASE III: [
…***…
]
|
4.1
|
Program Management
(Consistent with section 2.1)
|
4.1.12
|
Program management scope in BASE year is consistent with program management scope in each option year.
|
4.2
|
Non-Clinical toxicology
|
4.2.11
|
N/A (no scope)
|
4.3
|
Non-Clinical
|
4.3.7
|
[
…***…
] studies: A [
…***…
] study will be conducted with the [
…***…
] of CMX001 selected based on the results of the [
…***…
] and [
…***…
] studies. [
…***…
] will be [
…***…
] to receive [
…***…
] beginning at the [
…***…
] or the FDA agreed upon trigger for treatment. The first [
…***…
] study will be a [
…***…
] study of CMX001 in the [
…***…
] model. A study will be conducted with an [
…***…
] of CMX001 to determine the [
…***…
] after observation of the FDA agreed upon trigger for treatment. These studies will include [
…***…
] and [
…***…
]. The primary endpoint will be [
…***…
].
|
4.3.8
|
A [
…***…
] study of CMX001 in the [
…***…
]: The delayed treatment study will evaluate the [
…***…
] of CMX001 at [
…***…
]. The study will include [
…***…
] and [
…***…
] agreed upon with the FDA. The primary endpoint will be [
…***…
]. A [
…***…
] study to measure [
…***…
] in the selected [
…***…
] will be conducted to confirm the [
…***…
].
|
4.3.9
|
Conduct additional studies in [
…***…
] to determine [
…***…
] and [
…***…
] for CMX001 at [
…***…
].
|
4.3.10
|
Conduct [
…***…
] of [
…***…
].
|
4.4
|
Clinical
|
4.4.7
|
Clinical [
…***…
] studies to evaluate [
…***…
] used in previous clinical studies and [
…***…
] used in previous clinical studies and [
…***…
]. This study will [
…***…
] to [
…***…
] to determine if [
…***…
] are comparable.
|
4.5
|
Regulatory
|
4.5.2
|
Generating all necessary data and preparing documentation for an [
…***…
] meeting submissions to regulatory agencies;
|
4.5.3
|
Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including the [
…***…
] Meeting, meetings to review [
…***…
], EUA (if needed) and/or all other data packages;
|
4.5.4
|
Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to this Contract; (ii) final draft minutes of any informal meeting with the FDA;
|
4.5.5
|
Preparing an [
…***…
] submission [
…***…
].
|
4.6
|
CMC
|
4.6.1
|
[
…***…
] in order to generate [
…***…
] for registration and clinical trial supplies.
|
4.6.2
|
[
…***…
]. Validation of the process to demonstrate the [
…***…
] of a [
…***…
] of acceptable quality will be performed.
|
5.
|
PHASE IV: [
…***…
]
|
5.1
|
Program Management
(Consistent with section 2.1)
|
5.1.12
|
Program management scope in BASE year is consistent with program management scope in each option year.
|
5.2
|
Non-Clinical toxicology
|
5.2.11
|
N/A (no scope)
|
5.3
|
Non-Clinical
|
5.3.8
|
[
…***…
] studies. [
…***…
] will be randomized to receive [
…***…
] beginning at the [
…***…
]. These studies will include [
…***…
] and [
…***…
] as well as [
…***…
] including [
…***…
]. The primary endpoint will be [
…***…
]
|
5.3.9
|
[
…***…
] Studies. This study will determine the [
…***…
] at the [
…***…
]. [
…***…
] and [
…***…
] at the [
…***…
]. The primary endpoint will be [
…***…
]. If FDA requires a [
…***…
] in the [
…***…
] studies, the [
…***…
] study may not be needed.
|
5.3.10
|
Conduct [
…***…
] Studies. This study will determine the [
…***…
] at the [
…***…
]. [
…***…
] and [
…***…
] at the [
…***…
].
|
5.4
|
Clinical
|
5.4.6
|
Phase 3 development including [
…***…
] study, [
…***…
] study, phases II [
…***…
] study. A [
…***…
] study will be conducted to compare the [
…***…
] of CMX001 in [
…***…
] to [
…***…
]. A [
…***…
] study will be conducted to compare the [
…***…
] of CMX001 when [
…***…
]. A [
…***…
] study will be conducted to [
…***…
] to support an NDA.
|
5.4.7
|
Measurement of [
…***…
] in [
…***…
] and correlate the [
…***…
] to studies conducted in [
…***…
] (if required).
|
5.4.8
|
Compile [
…***…
] for NDA submission. A [
…***…
] collected from all CMX001 studies, irrespective of indication, will be populated and analyzed in order to support an NDA for smallpox.
|
5.5
|
Regulatory
|
5.5.3
|
Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;
|
5.5.4
|
Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, EUA and/or all other data packages;
|
5.6
|
CMC
|
5.6.1
|
[
…***…
]. [
…***…
] of the process to demonstrate the [
…***…
] of a [
…***…
] will be performed.
|
6.
|
PHASE V: [
…***…
]
|
6.1
|
Program Management
(Consistent with section 2.1)
|
6.1.12
|
Program management scope in BASE year is consistent with program management scope in each option year.
|
6.2
|
Non-Clinical toxicology
|
6.2.11
|
N/A (no scope)
|
6.3
|
Non-Clinical
|
6.3.9
|
[
…***…
] Studies. This study replicates [
…***…
] if a larger sample size is necessary to achieve a [
…***…
] result.
|
6.4
|
Clinical
|
6.4.5
|
Compile [
…***…
]. A database of [
…***…
] data collected from all CMX001 clinical studies, irrespective of [
…***…
], will be populated and analyzed in order to support an NDA for smallpox.
|
6.5
|
Regulatory
|
6.5.2
|
Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;
|
6.5.3
|
Submitting NDA documentation to the FDA in a timely manner, consistent with timelines set out in the contract and by the FDA.
|
6.5.4
|
Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, EUA and/or all other data packages;
|
6.5.5
|
Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA;
|
6.6
|
CMC
|
6.6.1
|
[
…***…
]. [
…***…
] of the process to demonstrate the [
…***…
] of a [
…***…
] will be performed.
|
7.
|
Other Items
|
7.1
|
Facilities, Equipment and Other Resources. (Contract: Section J)
|
7.1.13
|
The [
…***…
] and use of [
…***…
];
|
7.1.14
|
The acquisition, handling, storage and shipment of [
…***…
], including [
…***…
] required for working with the [
…***…
];
|
7.1.15
|
The [
…***…
] of [
…***…
] under cGMP;
|
7.1.15.1
|
The design and conduct of [
…***…
]; and
|
7.1.15.2
|
The conduct of [
…***…
] studies to determine [
…***…
] of [
…***…
]
|
7.1.16
|
Design and conduct of [
…***…
] under GCP.
|
REVISED MILESTONES ARTICLE F.2 DELIVERABLES
|
||||||
Current
Milestone # |
Milestone Definition
|
Go Criteria
|
No-Go Criteria
|
Deliverable
|
WBS/SOW #
|
Segment
|
1.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
2.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
3.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
4.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
5.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
6.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
7.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
8.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
9.
|
No longer in development plan.
|
|
|
|
N/A
|
N/A
|
10.
|
No longer in development plan.
|
|
|
|
N/A
|
N/A
|
11.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
12.
|
No longer in development plan.
|
|
|
|
N/A
|
N/A
|
13.
|
No longer in development plan.
|
|
|
|
N/A
|
N/A
|
14.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
15.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
16.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
17.
|
No longer in development plan.
|
|
|
|
N/A
|
N/A
|
18.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
19.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
20.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
21.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
22.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
23.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
24.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
25.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
26.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
BCA MILESTONE
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
NEW OPTION 1 MILESTONE TO BE ADDED TO ARTICLE F.2 DELIVERABLES OF THE CONTRACT
|
||||||
28.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
29.
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
[…***…]
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0019
|
PAGE OF
|
||||||
2
|
2
|
|||||||
NAME OF OFFEROR OR CONTACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
2. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged.
B. This is a no cost bilateral modification. All other terms and conditions of contract number HHS0100201100013C remain unchanged.
Period of Performance: 02/16/2011 to 11/30/2015
|
|
|
|
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0019
|
PAGE OF
|
||||||
2
|
2
|
|||||||
NAME OF OFFEROR OR CONTACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
B. This is a unilateral, administrative, no cost modification. The total contract amount and all other terms and conditions remain unchanged.
Period of Performance: 02/16/2011 to 11/30/2015
|
|
|
|
|
CONTINUATION SHEET
|
REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/0019
|
PAGE OF
|
||||||
2
|
2
|
|||||||
NAME OF OFFEROR OR CONTACTOR
CHIMERIX, INC. 1377270
|
||||||||
ITEM NO.
(A)
|
SUPPLIES/SERVICES
(B)
|
QUANTITY
(C)
|
UNIT
(D)
|
UNIT PRICE
(E)
|
AMOUNT
(F)
|
|||
|
2. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged.
B. This is a no cost bilateral modification. All other terms and conditions of contract number HHS0100201100013C remain unchanged.
Period of Performance: 02/16/2011 to 11/30/2015
|
|
|
|
|
1.
|
Registration Statement (Form S-3 Nos. 333-199683 and 195626) of Chimerix, Inc.,
|
2.
|
Registration Statement (Form S-8 No. 333-187860) pertaining to the 2002 Equity Incentive Plan, 2012 Equity Incentive Plan, 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc., and
|
3.
|
Registration Statement (Form S-8 No. 333-194408) pertaining to the 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc.;
|
|
|
/s/ Ernst & Young LLP
|
|
|
|
Raleigh, North Carolina
|
|
|
March 6, 2015
|
|
|
|
|
|
Date:
|
March 6, 2015
|
|
/s/ M. Michelle Berrey
|
|
|
|
M. Michelle Berrey, MD, MPH
|
|
|
|
President & Chief Executive Officer
|
Date:
|
March 6, 2015
|
|
/s/ Timothy W. Trost
|
|
|
|
Timothy W. Trost
Senior Vice President, Chief Financial Officer and Corporate Secretary
|
Date:
|
March 6, 2015
|
|
/s/ M. Michelle Berrey
|
|
|
|
M. Michelle Berrey, MD, MPH
|
|
|
|
President & Chief Executive Officer
|
Date:
|
March 6, 2015
|
|
/s/ Timothy W. Trost
|
|
|
|
Timothy W. Trost
Senior Vice President, Chief Financial Officer and Corporate Secretary
|