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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
(State or other jurisdiction of
incorporation or organization)
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2834
(Primary Standard Industrial
Classification Code Number)
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42-1560076
(I.R.S. Employer
Identification Number)
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1900 Powell Street, Suite 750
Emeryville, CA 94608
(510) 450-3500
(Address, including zip code, and telephone number, including area code, of Principal Executive Offices)
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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 Global Market
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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☐ (Do not check if a smaller reporting company)
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Smaller reporting company
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Emerging growth company
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Page
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Part I
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Item 1.
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Item 1A.
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Item 1B.
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Item 2.
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Item 3.
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Item 4.
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Part II
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Item 5.
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Item 6.
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Item 7.
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Item 7A.
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Item 8.
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Item 9.
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Item 9A.
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Item 9B.
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Part III
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Item 10.
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Item 11.
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Item 12.
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Item 13.
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Item 14.
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Part IV
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Item 15.
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Item 16.
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our expectation as to the therapeutic profile of our products and product candidates, including the safety and efficacy thereof;
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our expectations as to whether we will be able to obtain and maintain regulatory approval of our product candidates;
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our expectations as to whether we will be able to successfully commercialize GOCOVRI
TM
and any of our other products that are approved;
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the rate and degree of market acceptance of our products in the future;
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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
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the anticipated scope, rate of progress and cost of our preclinical studies and clinical trials and other research and development activities;
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the potential cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;
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the anticipated cost and timing of regulatory submissions and approvals;
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our expectation as to the legal proceedings and related stays and terms of settlements;
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our expectations as to the sufficiency of our capital resources to enable us to complete our ongoing clinical studies;
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our expectations as to our ability to obtain and maintain intellectual property protection for our products and product candidates;
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our expectations as to our ability to negotiate manufacturing arrangements and scale up manufacturing of our product candidates to commercial scale;
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the anticipated performance by our collaboration partners over which we do not have control;
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the anticipated receipt and timing of any royalties from our collaborators;
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our expectations as to our ability to successfully establish and successfully maintain appropriate collaborations and derive significant revenue from those collaborations;
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the anticipated performance of third parties to conduct our clinical studies;
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the anticipated ability of third-party contract manufacturers to manufacture and supply our product candidates for us;
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our expectations as to our ability to identify, develop, acquire and in-license new products and product candidates;
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our expectations as to our ability to initiate new or continue clinical development programs;
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our expectations as to our ability to initiate sites and enroll patients in our clinical studies at the pace that we project;
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our expectations as to our ability to retain and recruit key 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;
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our anticipated financial performance; and
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our anticipated developments and projections relating to our competitors or our industry.
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GOCOVRI
TM
(amantadine) extended release capsules, formerly referred to as ADS-5102, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI was approved for marketing by the U.S. Food and Drug Administration, or FDA, on August 24, 2017, with seven years of orphan exclusivity and additional patent protections, and we fully launched GOCOVRI with a deployed sales force in January 2018.
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ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. We expect the start of our Phase 3 pivotal study in this supplemental indication to occur early in the second quarter of 2018.
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ADS-5102 in research and potential development for additional indications, including the treatment of wearing OFF and delaying motor complications in Parkinson’s disease, tardive dyskinesia, Huntington’s chorea, Tourette syndrome, and non-motor disorders, including depression, and anti-psychotic induced weight gain. We expect to select additional indications for ADS-5102 by first quarter 2019.
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ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy. We have requested a meeting with the FDA in the first half of 2018, with the start of a Phase 3 pivotal study planned for 2019, depending on FDA feedback.
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Additional product candidates in research based on potential new discoveries in Parkinson’s disease, multiple sclerosis, epilepsy, as well as new research programs in psychiatry.
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Namzaric
®
(memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer’s type, marketed in the United States by Allergan plc under an exclusive license agreement between us and Forest Laboratories Holdings Limited (“Forest”), an indirect wholly-owned subsidiary of Allergan plc.
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Namenda XR
®
(memantine hydrochloride) extended release capsules for the treatment of moderate to severe dementia of an Alzheimer’s type, marketed in the United States by Allergan plc under the Forest license agreement.
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A 41% reduction in dyskinesia as measured on the Unified Dyskinesia Rating Scale total score, compared to 14% for placebo at week 12;
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A reduction in OFF time of approximately one hour per day (placebo adjusted); and
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An increase of approximately 4.0 hours in functional time daily (or ON time without troublesome dyskinesia).
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Additional programs in epilepsy, based upon our seizure profile discoveries;
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New programs in psychiatry;
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Additional Parkinson’s products, alone and potentially in combination with ADS-5102; and
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Additional Multiple sclerosis products, alone and potentially in combination with ADS-5102.
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Providing updates on our commercial progress with GOCOVRI quarterly;
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Presenting data at key annual scientific meetings, including the American Academy of Neurology (AAN), Movement Disorder Society (MDS), as well as publishing additional preclinical, Phase 1 and Phase 3 results for GOCOVRI; and
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Reporting final EASE LID 2 Phase 3 open-label safety and efficacy data.
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Starting first Phase 3 study in MS Walking in early second quarter 2018;
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Starting an open-label safety and efficacy study by fourth quarter 2018;
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Completing enrollments in a first Phase 3 study in MS Walking by the second half of 2019; and
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Advancing additional indications for ADS-5102 by first quarter 2019.
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Conducting a meeting with the FDA in the first half of 2018; and
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Enrolling in Phase 3 study patients with partial onset seizures with epilepsy in 2019-2020 (pending FDA feedback).
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Advancing two research programs into clinical development by the second half of 2020.
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nonclinical laboratory and animal tests, including some that must be conducted in accordance with Good Laboratory Practices;
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submission of an IND, which must become effective before clinical trials may begin;
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adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug candidate for its intended use;
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pre-approval inspection of manufacturing facilities and selected clinical investigators for their compliance with cGMP and Good Clinical Practices; and
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FDA approval of an NDA to permit commercial marketing for particular indications for use.
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Phase 1—Studies are initially conducted to test the product candidate for safety, dosage tolerance, absorption, metabolism, distribution, and excretion in healthy volunteers or patients.
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Phase 2—Studies are conducted with groups of patients with a specified disease or condition to provide enough data to evaluate the preliminary efficacy, optimal dosages and dosing schedule, and expanded evidence of safety. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.
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Phase 3—These clinical trials are undertaken in larger patient populations to further evaluate dosage, to provide statistically significant evidence of clinical efficacy, and to further test for safety in an expanded patient population at multiple 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. These trials may be done globally to support global registrations.
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our success in commercializing GOCOVRI, including the marketing, sales, and distribution of the product;
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successfully establishing and maintaining commercial manufacturing with third parties;
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acceptance of GOCOVRI by physicians, patients and the healthcare community;
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the acceptance of pricing and placement of GOCOVRI on payers’ formularies and the associated tiers;
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effectively competing with other approved or used medicines and future compounds in development;
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continued demonstration of an acceptable safety profile of GOCOVRI following approval; and
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obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
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its efficacy, duration of response, and potential advantages compared to alternative treatments;
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the prevalence and severity of any side effects;
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the acceptability of the price of GOCOVRI relative to other treatments;
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the willingness of physicians to change their current treatment practices;
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its convenience and ease of administration compared to alternative treatments;
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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
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the effectiveness of our marketing, promotion, selling, and distribution support; and
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the availability of third-party insurance coverage or reimbursement.
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have the product removed from the market;
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be subject to additional post-marketing testing requirements; or
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be subject to restrictions on how the product is distributed, marketed, or used.
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regulatory authorities may require the addition of labeling statements, specific warnings, contraindications, or field alerts to physicians and pharmacies;
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regulatory authorities may withdraw their approval of the product and require us to take our approved drugs off the market;
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we may be required to change the way the product is administered, conduct additional clinical trials, change the labeling of the product, or implement a Risk Evaluation and Mitigation Strategy, or REMS;
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we may have limitations on how we promote our drugs;
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third-party payers may limit coverage or reimbursement for GOCOVRI;
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sales of GOCOVRI may decrease significantly;
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we may be subject to litigation or product liability claims; and
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our reputation may suffer.
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decreased demand for any product candidates or products that we may develop;
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the inability to commercialize any products that we may develop;
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injury to our reputation and significant negative media attention;
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withdrawal of patients from clinical studies or cancellation of studies;
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significant costs to defend the related litigation;
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substantial monetary awards to patients; and
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loss of revenue.
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successfully completing the development program for our product candidates in a timely manner;
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receiving marketing approval for our product candidates from the FDA in a timely manner;
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successfully establishing and maintaining commercial manufacturing with third parties;
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commercializing our product candidates, if approved, including marketing, sales, and distribution of the product independently or in partnership with another company;
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acceptance by the medical community and patients of the approved product;
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the pricing and placement of our product candidates on payers’ formulary tiers and the reimbursement rates established for the approved products;
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effectively competing with other approved or used medicines and future compounds in development;
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continued demonstration of an acceptable safety profile of the approved products following approval; and
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obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
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clinical studies may produce negative or inconclusive results or raise significant safety concerns, and we may decide, or regulators may require us, to conduct additional clinical studies or abandon product development programs;
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even if clinical studies demonstrate statistically significant efficacy and acceptable safety, the FDA or similar authorities outside the United States may not consider the results of our studies to be sufficient for approval;
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our clinical sites and clinical investigators may fail to comply with, or inconsistently apply, the trial protocols, regulatory requirements including Good Clinical Practices, contractual obligations, and the rating assessments;
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our third-party vendors, including our Contract Research Organizations, or CROs, and contract manufacturing organizations, or CMOs, 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 studies for various reasons, including a finding that our product candidates have unanticipated serious side effects or other unexpected characteristics or that the patients 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 supply or quality of ADS-5102, ADS-4101, or other materials necessary to conduct clinical studies may be insufficient or inadequate; and
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our new product discovery or research program may not be successful or warrant clinical development.
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partners have significant discretion in determining the efforts and resources that they will apply to collaborations;
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partners may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical study results, changes in their strategic focus due to the acquisition of competitive products, availability of funding, or other external factors, such as a business combination that diverts resources or creates competing priorities;
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partners may delay clinical studies, provide insufficient funding for a clinical study program, stop a clinical study, abandon a product candidate, repeat or conduct new clinical studies, or require a new formulation of a product candidate for clinical testing;
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partners could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
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a partner with marketing, manufacturing, and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
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we could grant exclusive rights to our partners that would prevent us from collaborating with others;
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Allergan and future partners may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
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Allergan and future partners may not aggressively or adequately pursue litigation against ANDA filers or may settle such litigation on unfavorable terms, and as Allergan substantially controls the current ANDA litigation and terms of settlement and has different economic interests than ours, Allergan may grant licenses to generic manufacturers that permit them to make and sell generic versions of Namenda XR
and Namzaric, which would negatively impact any royalties we may receive under our license with Allergan;
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disputes may arise between us and a partner that causes the delay or termination of the research, development, or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
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agreements may be terminated, sometimes at-will, without penalty, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products;
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partners may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property; and
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a partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
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disagreement with the design or implementation of our clinical trials;
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failure of clinical trials to show the level of statistical significance or clinical meaningfulness needed for approval;
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failure to demonstrate that a product candidate is safe or effective;
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insufficient data from preclinical and clinical studies to support an application;
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a finding by an institutional review board, or IRB, Data Safety Monitoring Board, or DSMB, Data Monitoring Committee, or DMC, or the FDA that the clinical trial exposes subjects or patients to an unacceptable health risk;
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disapproval of our or our third-party manufacturer’s processes or facilities; or
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changes to FDA’s approval policies or regulations.
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warning letters or untitled letters;
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civil or criminal penalties and fines;
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injunctions;
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suspension, variation, or withdrawal of regulatory approval;
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suspension of ongoing clinical studies;
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voluntary or mandatory product recalls;
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requirements for dissemination of corrective information or modifications to promotional materials;
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refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications filed by us;
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refusal to permit import or export of our products;
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restrictions on operations, including costly new manufacturing requirements; or
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seizure or detention of our products.
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our ability to set a price we believe is fair for our products;
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the reputation of our company;
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our ability to generate revenue and achieve or maintain profitability; and
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the availability of capital.
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the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving any 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, order, lease, arrangement 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 the Medicare and Medicaid programs. Liability under the Anti-Kickback Statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act;
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the federal civil and criminal false claims laws, and civil monetary penalties laws, including the federal civil False Claims Act, which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds, or knowingly using false records or statements, to obtain payment from the federal government. In recent years, several pharmaceutical and other health care companies have faced enforcement actions under the False Claims Act for, among other things, allegedly submitting false or misleading pricing information to government healthcare programs, providing free product to customers with the expectation that the customers would bill federal programs, product and patient assistance programs, including reimbursement services, and marketing products for off-label or unapproved uses;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or 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 payer (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements 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, or HITECH, and their implementing regulations, which impose obligations on HIPAA covered entities and their business associates, including mandatory contractual terms and required implementation of administrative, physical and technical safeguards to maintain the privacy and security of individually identifiable health information;
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the federal Physician Payments Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the federal government information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as certain ownership and investment interests held by physicians and their immediate family members; and
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analogous state laws and regulations, such as anti-kickback, and false claims laws, which may be broader in scope and apply to items or services reimbursed by any third-party payer, including commercial insurers. Several states also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain marketing-relating activities, including the provision of gifts, meals, or other items to certain health care providers. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
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determine the efforts and resources that they apply towards commercialization;
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market, manufacture, and distribute the licensed products or to otherwise not perform satisfactorily in carrying out these activities; and
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to terminate the agreement without penalty and, such termination, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products.
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maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; and
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not adequately pursue litigation against ANDA filers or settle such litigation on unfavorable terms, and as Allergan substantially controls the current ANDA litigation and terms of settlement and has different economic interests than ours, Allergan may grant licenses to generic manufacturers that permit them to make and sell generic versions of Namenda XR and Namzaric, which would negatively impact the royalties we receive under our license with Allergan.
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enhance operational, financial, and information management systems and hire more personnel, including personnel to support development of our product candidates and, our commercial operations;
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commercialize GOCOVRI, including establishing distribution, marketing, and sales capabilities;
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manufacture GOCOVRI for commercial use;
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investigate ADS-5102 (GOCOVRI) in preclinical and clinical trials for the treatment of walking impairment in patients with MS, and potentially other indications;
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conduct preclinical and clinical trials of ADS-4101 for the treatment of epilepsy (partial onset seizures);
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seek regulatory approvals for our product candidates that successfully complete clinical studies;
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continue the research, development, and manufacture of our current product candidates; and
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seek to discover or in-license additional product candidates.
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the level of demand for our products, which may vary significantly as they are launched and compete for position in the marketplace;
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pricing and reimbursement policies with respect to GOCOVRI and product candidates, if approved, and the competitive response from existing and potential future therapeutic approaches that compete with our product candidates;
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the cost of manufacturing our product candidates, which may vary due to a number of factors, including the terms of our agreements with contract manufacturing organizations, or CMOs;
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the timing, cost, level of investment, and success or failure of research and development activities relating to our preclinical and clinical-stage product candidates, which may change from time to time;
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expenditures that we may incur to acquire and develop additional product candidates and technologies;
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the timing and success or failure of clinical studies for competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
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the timing and magnitude of upfront and milestone payments under any potential future collaboration and licensing agreements;
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future accounting pronouncements or changes in our accounting policies; and
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changing or volatile U.S., European, and global economic environments.
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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 requirements;
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economic weakness, including inflation or political instability in particular foreign economies and markets;
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difficulties in assuring compliance with foreign corrupt practices laws;
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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 revenue, 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, hurricanes or typhoons, floods, and fires.
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our success in commercializing GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease;
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the availability of reimbursement by payers at acceptable levels, or at all, for GOCOVRI;
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the success of competitive products or technologies;
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results of clinical studies of our product candidates or those of our competitors;
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introductions and announcements of new products and product candidates by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements;
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actions taken by regulatory agencies with respect to our or our competitors’ products, product candidates, clinical studies, manufacturing process, or sales and marketing terms;
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variations in our financial results or those of companies that are perceived to be comparable to us;
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our revenue performance, both in absolute terms and relative to analyst and shareholder expectations;
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the success of our efforts to acquire or in-license additional products or product candidates;
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developments concerning our collaborations, including but not limited to those with our sources of manufacturing and our commercialization partners;
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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments;
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developments or disputes concerning patents or other proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our current or future products;
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our ability or inability to raise additional capital and the terms on which we raise it;
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the recruitment or departure of key personnel;
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changes in the structure of healthcare reimbursement systems;
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regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our current or future products;
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market conditions in the pharmaceutical and biotechnology sectors;
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actual or anticipated changes in revenue forecasts, earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally;
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trading volume of our common stock;
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sales of our common stock by us or our stockholders;
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general economic, industry, and market conditions; and
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the other risks described in this “Risk Factors” section.
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our board of directors is divided into three classes with staggered three-year terms, which may delay or prevent a change of our management or a change in control;
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•
|
our board of directors has the right to change the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
|
•
|
our stockholders may not act by written consent or call special stockholders’ meetings; as a result, a holder, or holders, controlling a majority of our capital stock would not be able to take certain actions other than at annual stockholders’ meetings or special stockholders’ meetings called by the board of directors or the chairman of the board and chief executive officer;
|
•
|
our certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
|
•
|
stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and
|
•
|
our board of directors may issue, without stockholder approval, shares of undesignated preferred stock, and the ability to issue undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to acquire us.
|
|
Low
|
|
High
|
||||
Fiscal Year ended December 31, 2016
|
|
|
|
||||
First Quarter
|
$
|
12.02
|
|
|
$
|
28.23
|
|
Second Quarter
|
$
|
13.94
|
|
|
$
|
19.15
|
|
Third Quarter
|
$
|
12.81
|
|
|
$
|
19.50
|
|
Fourth Quarter
|
$
|
12.10
|
|
|
$
|
17.74
|
|
|
|
|
|
||||
Fiscal Year ended December 31, 2017
|
|
|
|
|
|
||
First Quarter
|
$
|
14.23
|
|
|
$
|
19.50
|
|
Second Quarter
|
$
|
14.59
|
|
|
$
|
18.00
|
|
Third Quarter
|
$
|
13.50
|
|
|
$
|
23.84
|
|
Fourth Quarter
|
$
|
17.68
|
|
|
$
|
38.22
|
|
|
Years Ended December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
|
(in thousands, except per share data)
|
||||||||||||||||||
Consolidated Statement of Operations data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
Product sales, net
|
$
|
568
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
License and grant revenue
|
3
|
|
|
572
|
|
|
1,916
|
|
|
55,846
|
|
|
71,095
|
|
|||||
Total net revenues
|
571
|
|
|
572
|
|
|
1,916
|
|
|
55,846
|
|
|
71,095
|
|
|||||
Costs and operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of product sales
|
17
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Research and development
|
27,168
|
|
|
31,230
|
|
|
35,895
|
|
|
21,860
|
|
|
7,410
|
|
|||||
Selling, general and administrative, net
|
61,312
|
|
|
30,326
|
|
|
23,458
|
|
|
15,472
|
|
|
6,667
|
|
|||||
Total costs and operating expenses
|
88,497
|
|
|
61,556
|
|
|
59,353
|
|
|
37,332
|
|
|
14,077
|
|
|||||
Income (loss) from operations
|
(87,926
|
)
|
|
(60,984
|
)
|
|
(57,437
|
)
|
|
18,514
|
|
|
57,018
|
|
|||||
Interest and other income (expense), net
|
1,351
|
|
|
811
|
|
|
363
|
|
|
(917
|
)
|
|
(4,906
|
)
|
|||||
Interest expense
|
(4,645
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Income (loss) before income taxes
|
(91,220
|
)
|
|
(60,173
|
)
|
|
(57,074
|
)
|
|
17,597
|
|
|
52,112
|
|
|||||
Provision (benefit) for income taxes
|
(1,730
|
)
|
|
(115
|
)
|
|
(5,272
|
)
|
|
7,374
|
|
|
1,191
|
|
|||||
Net income (loss)
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
|
$
|
10,223
|
|
|
$
|
50,921
|
|
Net income (loss) attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
|
$
|
8,968
|
|
|
$
|
33,068
|
|
Diluted
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
|
$
|
9,069
|
|
|
$
|
35,353
|
|
Net income (loss) per share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
$
|
(3.97
|
)
|
|
$
|
(2.77
|
)
|
|
$
|
(2.86
|
)
|
|
$
|
0.60
|
|
|
$
|
3.48
|
|
Diluted
|
$
|
(3.97
|
)
|
|
$
|
(2.77
|
)
|
|
$
|
(2.86
|
)
|
|
$
|
0.53
|
|
|
$
|
2.99
|
|
Weighted average number of shares used in computing net income (loss) attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
22,558
|
|
|
21,711
|
|
|
18,111
|
|
|
14,837
|
|
|
9,506
|
|
|||||
Diluted
|
22,558
|
|
|
21,711
|
|
|
18,111
|
|
|
17,107
|
|
|
11,806
|
|
|
As of December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents, and available-for-sale securities
|
$
|
176,433
|
|
|
$
|
135,944
|
|
|
$
|
119,960
|
|
|
$
|
158,722
|
|
|
$
|
85,612
|
|
Working capital
|
162,568
|
|
|
107,244
|
|
|
101,380
|
|
|
110,982
|
|
|
81,790
|
|
|||||
Total assets
|
186,176
|
|
|
142,473
|
|
|
128,743
|
|
|
161,189
|
|
|
86,216
|
|
|||||
Long-term debt
|
102,647
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Warrant liability
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,232
|
|
|||||
Total liabilities
|
120,050
|
|
|
10,290
|
|
|
12,556
|
|
|
14,115
|
|
|
10,462
|
|
|||||
Convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19,149
|
|
|||||
Total stockholders’ equity
|
66,126
|
|
|
132,183
|
|
|
116,187
|
|
|
147,074
|
|
|
56,605
|
|
•
|
GOCOVRI
TM
(amantadine) extended release capsules, formerly referred to as ADS-5102, for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI was approved for marketing by the U.S. Food and Drug Administration, or FDA, on August 24, 2017, with seven years of orphan exclusivity and additional patent protections, and we fully launched GOCOVRI with a deployed sales force in January 2018.
|
•
|
ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. We expect the start of our Phase 3 pivotal study in this supplemental indication to occur early in the second quarter of 2018.
|
•
|
ADS-5102 in research and potential development for additional indications, including the treatment of wearing OFF and delaying motor complications in Parkinson’s disease, tardive dyskinesia, Huntington’s chorea, Tourette syndrome, and non-motor disorders, including depression, and anti-psychotic induced weight gain. We expect to select additional indications for ADS-5102 by first quarter 2019.
|
•
|
ADS-4101 (lacosamide) modified release capsules in development for the treatment of partial onset seizures in patients with epilepsy. We have requested a meeting with the FDA in the first half of 2018, with the start of a Phase 3 pivotal study planned for 2019, depending on FDA feedback.
|
•
|
Additional product candidates in research based on potential new discoveries in Parkinson’s disease, multiple sclerosis, epilepsy, as well as new research programs in psychiatry.
|
•
|
Namzaric
®
(memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer’s type, marketed in the United States by Allergan plc under an exclusive license agreement between us and Forest Laboratories Holdings Limited (“Forest”), an indirect wholly-owned subsidiary of Allergan plc.
|
•
|
Namenda XR
®
(memantine hydrochloride) extended release capsules for the treatment of moderate to severe dementia of an Alzheimer’s type, marketed in the United States by Allergan plc under the Forest license agreement.
|
|
December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Product sales, net
|
$
|
568
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Allergan reimbursement of development costs
|
3
|
|
|
317
|
|
|
1,434
|
|
|||
NIH grants and government contracts
|
—
|
|
|
255
|
|
|
482
|
|
|||
Total revenue
|
$
|
571
|
|
|
$
|
572
|
|
|
$
|
1,916
|
|
•
|
fees paid to clinical investigators, clinical trial sites, consultants, and vendors, including contract research organizations, or CROs, in conjunction with implementing, conducting, and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as for investigator grants, patient screening fees, laboratory work, and statistical compilation and analysis;
|
•
|
expenses related to production of clinical supplies, including fees paid to contract manufacturing organizations, or CMOs;
|
•
|
expenses related to establishment and validation of manufacturing capabilities for commercial supply;
|
•
|
expenses related to the buildup of commercial supply to support commercial launch, prior to FDA approval;
|
•
|
expenses related to compliance with regulatory requirements;
|
•
|
other consulting fees paid to third parties; and
|
•
|
employee-related expenses, which include salaries, benefits, and stock-based compensation.
|
|
December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
ADS-5102(1)
|
$
|
20,174
|
|
|
$
|
25,223
|
|
|
$
|
32,231
|
|
ADS-4101
|
5,202
|
|
|
1,659
|
|
|
—
|
|
|||
Other research and development expenses
|
1,792
|
|
|
4,348
|
|
|
3,664
|
|
|||
Total research and development expenses
|
$
|
27,168
|
|
|
$
|
31,230
|
|
|
$
|
35,895
|
|
(1)
|
Includes program costs we incurred for GOCOVRI (formerly referred to as ADS-5102) for the treatment of dyskinesia in patients with Parkinson’s disease, and ADS-5102 (GOCOVRI) for additional potential CNS indications, including for the treatment of walking impairment in patients with multiple sclerosis.
|
|
December 31,
|
|
Increase/
|
|
% Increase/
|
|||||||||
|
2017
|
|
2016
|
|
(Decrease)
|
|
(Decrease)
|
|||||||
Product sales, net
|
$
|
568
|
|
|
$
|
—
|
|
|
$
|
568
|
|
|
NM
|
|
License and grant revenue
|
3
|
|
|
572
|
|
|
(569
|
)
|
|
(99
|
)%
|
|||
Cost of product sales
|
17
|
|
|
—
|
|
|
17
|
|
|
NM
|
|
|||
Research and development expenses
|
27,168
|
|
|
31,230
|
|
|
(4,062
|
)
|
|
(13
|
)%
|
|||
Selling, general and administrative expenses, net
|
61,312
|
|
|
30,326
|
|
|
30,986
|
|
|
102
|
%
|
|||
Interest and other income, net
|
1,351
|
|
|
811
|
|
|
540
|
|
|
67
|
%
|
|||
Interest expense
|
4,645
|
|
|
—
|
|
|
4,645
|
|
|
NM
|
|
|
December 31,
|
|
Increase/
|
|
% Increase/
|
|||||||||
|
2016
|
|
2015
|
|
(Decrease)
|
|
(Decrease)
|
|||||||
License and grant revenue
|
$
|
572
|
|
|
$
|
1,916
|
|
|
$
|
(1,344
|
)
|
|
(70
|
)%
|
Research and development expenses
|
31,230
|
|
|
35,895
|
|
|
(4,665
|
)
|
|
(13
|
)%
|
|||
Selling, general and administrative expenses, net
|
30,326
|
|
|
23,458
|
|
|
6,868
|
|
|
29
|
%
|
|||
Interest and other income, net
|
811
|
|
|
363
|
|
|
448
|
|
|
(123
|
)%
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net cash (used in) provided by:
|
|
|
|
|
|
||||||
Operating activities
|
$
|
(66,827
|
)
|
|
$
|
(48,068
|
)
|
|
$
|
(47,210
|
)
|
Investing activities
|
25,565
|
|
|
(26,709
|
)
|
|
8,058
|
|
|||
Financing activities
|
108,843
|
|
|
65,408
|
|
|
10,810
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
$
|
67,581
|
|
|
$
|
(9,369
|
)
|
|
$
|
(28,342
|
)
|
|
|
|
Payments Due by Period
|
||||||||||||||||
|
Total
|
|
Less than
1 Year
|
|
2 - 3 Years
|
|
4 - 5 Years
|
|
More than
5 Years
|
||||||||||
Contractual obligations:
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating lease obligations
|
$
|
1,510
|
|
|
$
|
633
|
|
|
$
|
877
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Purchase commitments
|
4,882
|
|
|
3,149
|
|
|
1,733
|
|
|
—
|
|
|
—
|
|
|||||
Total contractual obligations
|
$
|
6,392
|
|
|
$
|
3,782
|
|
|
$
|
2,610
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Consolidated Financial Statements
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
91,316
|
|
|
$
|
23,735
|
|
Available-for-sale securities
|
82,126
|
|
|
89,917
|
|
||
Accounts receivable, net
|
367
|
|
|
794
|
|
||
Inventory
|
1,704
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
3,662
|
|
|
2,541
|
|
||
Total current assets
|
179,175
|
|
|
116,987
|
|
||
Property and equipment, net
|
3,132
|
|
|
3,156
|
|
||
Available-for-sale securities, non-current
|
2,991
|
|
|
22,292
|
|
||
Other assets
|
878
|
|
|
38
|
|
||
Total assets
|
$
|
186,176
|
|
|
$
|
142,473
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
3,878
|
|
|
$
|
3,589
|
|
Accrued liabilities
|
12,385
|
|
|
5,867
|
|
||
Other current liabilities
|
344
|
|
|
287
|
|
||
Total current liabilities
|
16,607
|
|
|
9,743
|
|
||
Long-term debt
|
102,647
|
|
|
—
|
|
||
Other non-current liabilities
|
796
|
|
|
547
|
|
||
Total liabilities
|
120,050
|
|
|
10,290
|
|
||
Commitments and Contingencies (Note 8)
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at December 31, 2017 and December 31, 2016
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value — 100,000,000 shares authorized, 23,320,551 and 22,013,644 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively
|
28
|
|
|
27
|
|
||
Additional paid-in capital
|
277,964
|
|
|
254,558
|
|
||
Accumulated other comprehensive loss
|
(167
|
)
|
|
(193
|
)
|
||
Accumulated deficit
|
(211,699
|
)
|
|
(122,209
|
)
|
||
Total stockholders’ equity
|
66,126
|
|
|
132,183
|
|
||
Total liabilities and stockholders’ equity
|
$
|
186,176
|
|
|
$
|
142,473
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
568
|
|
|
$
|
—
|
|
|
$
|
—
|
|
License and grant revenue
|
3
|
|
|
572
|
|
|
1,916
|
|
|||
Total net revenues
|
571
|
|
|
572
|
|
|
1,916
|
|
|||
Costs and operating expenses:
|
|
|
|
|
|
||||||
Cost of product sales
|
17
|
|
|
—
|
|
|
—
|
|
|||
Research and development
|
27,168
|
|
|
31,230
|
|
|
35,895
|
|
|||
Selling, general and administrative, net
|
61,312
|
|
|
30,326
|
|
|
23,458
|
|
|||
Total costs and operating expenses
|
88,497
|
|
|
61,556
|
|
|
59,353
|
|
|||
Loss from operations
|
(87,926
|
)
|
|
(60,984
|
)
|
|
(57,437
|
)
|
|||
Interest and other income, net
|
1,351
|
|
|
811
|
|
|
363
|
|
|||
Interest expense
|
(4,645
|
)
|
|
—
|
|
|
—
|
|
|||
Loss before income taxes
|
(91,220
|
)
|
|
(60,173
|
)
|
|
(57,074
|
)
|
|||
Benefit for income taxes
|
(1,730
|
)
|
|
(115
|
)
|
|
(5,272
|
)
|
|||
Net loss
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
Net loss per share, basic and diluted
|
$
|
(3.97
|
)
|
|
$
|
(2.77
|
)
|
|
$
|
(2.86
|
)
|
Weighted average shares used in computing net loss per share, basic and diluted
|
22,558
|
|
|
21,711
|
|
|
18,111
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net loss
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
Unrealized gain (loss) on available-for-sale securities
|
26
|
|
|
(35
|
)
|
|
22
|
|
|||
Comprehensive loss
|
$
|
(89,464
|
)
|
|
$
|
(60,093
|
)
|
|
$
|
(51,780
|
)
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total Stockholders’ Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balances at December 31, 2014
|
17,551,375
|
|
|
$
|
22
|
|
|
$
|
157,581
|
|
|
$
|
(180
|
)
|
|
$
|
(10,349
|
)
|
|
$
|
147,074
|
|
Exercise of stock options
|
409,683
|
|
|
—
|
|
|
761
|
|
|
—
|
|
|
—
|
|
|
761
|
|
|||||
Vesting of common stock
|
—
|
|
|
—
|
|
|
112
|
|
|
—
|
|
|
—
|
|
|
112
|
|
|||||
Issuance of common stock in conjunction with Controlled Equity Offering, net of commissions and issuance costs
|
509,741
|
|
|
1
|
|
|
9,656
|
|
|
—
|
|
|
—
|
|
|
9,657
|
|
|||||
Issuance of common stock in conjunction with warrant exercises
|
3,484
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net unrealized gain on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
—
|
|
|
22
|
|
|||||
Stock issued under employee stock purchase plan
|
31,179
|
|
|
—
|
|
|
407
|
|
|
—
|
|
|
—
|
|
|
407
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
9,956
|
|
|
—
|
|
|
—
|
|
|
9,956
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(51,802
|
)
|
|
(51,802
|
)
|
|||||
Balances at December 31, 2015
|
18,505,462
|
|
|
$
|
23
|
|
|
$
|
178,473
|
|
|
$
|
(158
|
)
|
|
$
|
(62,151
|
)
|
|
$
|
116,187
|
|
Exercise of stock options
|
586,956
|
|
|
1
|
|
|
3,041
|
|
|
—
|
|
|
—
|
|
|
3,042
|
|
|||||
Vesting of common stock
|
—
|
|
|
—
|
|
|
34
|
|
|
—
|
|
|
—
|
|
|
34
|
|
|||||
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs
|
2,875,000
|
|
|
3
|
|
|
61,819
|
|
|
—
|
|
|
—
|
|
|
61,822
|
|
|||||
Net unrealized loss on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
(35
|
)
|
|
—
|
|
|
(35
|
)
|
|||||
Stock issued under employee stock purchase plan
|
46,226
|
|
|
—
|
|
|
620
|
|
|
—
|
|
|
—
|
|
|
620
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
10,571
|
|
|
—
|
|
|
—
|
|
|
10,571
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(60,058
|
)
|
|
(60,058
|
)
|
|||||
Balances at December 31, 2016
|
22,013,644
|
|
|
$
|
27
|
|
|
$
|
254,558
|
|
|
$
|
(193
|
)
|
|
$
|
(122,209
|
)
|
|
$
|
132,183
|
|
Exercise of stock options
|
1,183,353
|
|
|
1
|
|
|
9,033
|
|
|
—
|
|
|
—
|
|
|
9,034
|
|
|||||
Restricted stock units vested
|
64,471
|
|
|
—
|
|
|
201
|
|
|
—
|
|
|
—
|
|
|
201
|
|
|||||
Stock issued under employee stock purchase plan
|
59,083
|
|
|
—
|
|
|
766
|
|
|
—
|
|
|
—
|
|
|
766
|
|
|||||
Net unrealized gain on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
26
|
|
|
—
|
|
|
26
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
13,406
|
|
|
—
|
|
|
—
|
|
|
13,406
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(89,490
|
)
|
|
(89,490
|
)
|
|||||
Balances at December 31, 2017
|
23,320,551
|
|
|
$
|
28
|
|
|
$
|
277,964
|
|
|
$
|
(167
|
)
|
|
$
|
(211,699
|
)
|
|
$
|
66,126
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Cash flows from operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
||||||
Depreciation
|
1,194
|
|
|
808
|
|
|
435
|
|
|||
Stock-based compensation
|
13,367
|
|
|
10,571
|
|
|
9,956
|
|
|||
Non-cash interest expense
|
4,645
|
|
|
—
|
|
|
—
|
|
|||
Change in fair value of embedded derivative liability
|
(294
|
)
|
|
—
|
|
|
—
|
|
|||
Net accretion of discounts and amortization of premiums of available-for-sale securities
|
456
|
|
|
(301
|
)
|
|
875
|
|
|||
Changes in assets and liabilities
|
|
|
|
|
|
||||||
Accrued interest of available-for-sale securities
|
(161
|
)
|
|
(2
|
)
|
|
110
|
|
|||
Inventory
|
(1,646
|
)
|
|
—
|
|
|
—
|
|
|||
Prepaid expenses and other assets
|
(2,036
|
)
|
|
2,643
|
|
|
(4,416
|
)
|
|||
Accounts receivable, net
|
427
|
|
|
490
|
|
|
(760
|
)
|
|||
Accounts payable
|
333
|
|
|
502
|
|
|
(788
|
)
|
|||
Accrued liabilities and other liabilities
|
6,378
|
|
|
(2,721
|
)
|
|
(820
|
)
|
|||
Net cash used in operating activities
|
(66,827
|
)
|
|
(48,068
|
)
|
|
(47,210
|
)
|
|||
Cash flows from investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(1,258
|
)
|
|
(1,624
|
)
|
|
(1,399
|
)
|
|||
Purchases of available-for-sale securities
|
(62,510
|
)
|
|
(103,528
|
)
|
|
(59,828
|
)
|
|||
Maturities of available-for-sale securities
|
89,333
|
|
|
78,443
|
|
|
69,285
|
|
|||
Net cash provided by (used in) investing activities
|
25,565
|
|
|
(26,709
|
)
|
|
8,058
|
|
|||
Cash flows from financing activities
|
|
|
|
|
|
||||||
Proceeds from issuance of long-term debt
|
99,600
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from public offerings, net of offering costs
|
—
|
|
|
61,822
|
|
|
9,657
|
|
|||
Payment of debt issuance costs
|
(633
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from issuance of common stock upon exercise of stock options
|
9,110
|
|
|
2,966
|
|
|
746
|
|
|||
Proceeds from employee stock purchase plan
|
766
|
|
|
620
|
|
|
407
|
|
|||
Net cash provided by financing activities
|
108,843
|
|
|
65,408
|
|
|
10,810
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
67,581
|
|
|
(9,369
|
)
|
|
(28,342
|
)
|
|||
Cash and cash equivalents at beginning of period
|
23,735
|
|
|
33,104
|
|
|
61,446
|
|
|||
Cash and cash equivalents at end of period
|
$
|
91,316
|
|
|
$
|
23,735
|
|
|
$
|
33,104
|
|
Supplemental disclosure
|
|
|
|
|
|
||||||
Cash paid for income taxes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,691
|
|
Supplemental disclosure of noncash investing and financing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment in accounts payable and accrued expense
|
$
|
61
|
|
|
$
|
148
|
|
|
$
|
161
|
|
Stock-based compensation capitalized in inventory
|
$
|
39
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Stock option exercise settled after period end
|
$
|
—
|
|
|
$
|
76
|
|
|
$
|
—
|
|
|
Useful Lives
|
Computer equipment and software
|
3 years
|
Equipment
|
5 years
|
Furniture and fixtures
|
10 years
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Prepaid expenses
|
$
|
2,638
|
|
|
$
|
1,316
|
|
Income tax receivable
|
1,007
|
|
|
168
|
|
||
Other current assets
|
17
|
|
|
1,057
|
|
||
Prepaid expenses and other current assets
|
$
|
3,662
|
|
|
$
|
2,541
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Computer equipment and software
|
$
|
3,289
|
|
|
$
|
2,128
|
|
Equipment
|
252
|
|
|
252
|
|
||
Furniture and fixtures
|
466
|
|
|
466
|
|
||
Leasehold improvements
|
1,645
|
|
|
1,645
|
|
||
|
5,652
|
|
|
4,491
|
|
||
Less: Accumulated depreciation and amortization
|
(2,520
|
)
|
|
(1,335
|
)
|
||
Property and equipment, net
|
$
|
3,132
|
|
|
$
|
3,156
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Accrued employee related costs
|
$
|
5,499
|
|
|
$
|
3,696
|
|
Clinical trial accruals
|
1,720
|
|
|
1,041
|
|
||
Accrued consulting and other professional fees
|
4,897
|
|
|
864
|
|
||
Other
|
269
|
|
|
266
|
|
||
Accrued liabilities
|
$
|
12,385
|
|
|
$
|
5,867
|
|
•
|
Level 1 inputs, which include quoted prices in active markets for identical assets or liabilities;
|
•
|
Level 2 inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For available-for-sale securities, the Company reviews trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and
|
•
|
Level 3 inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgment or estimation.
|
|
December 31, 2017
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market
|
$
|
68,501
|
|
|
$
|
68,501
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
23,471
|
|
|
—
|
|
|
23,471
|
|
|
—
|
|
||||
U.S. Treasury notes
|
61,646
|
|
|
—
|
|
|
61,646
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
153,618
|
|
|
$
|
68,501
|
|
|
$
|
85,117
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded derivative liability
|
$
|
470
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
470
|
|
Total liabilities measured at fair value
|
$
|
470
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
470
|
|
|
December 31, 2016
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market
|
$
|
192
|
|
|
$
|
192
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
51,233
|
|
|
—
|
|
|
51,233
|
|
|
—
|
|
||||
U.S. Treasury notes
|
60,976
|
|
|
—
|
|
|
60,976
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
112,401
|
|
|
$
|
192
|
|
|
$
|
112,209
|
|
|
$
|
—
|
|
Balance as of December 31, 2016
|
|
$
|
—
|
|
Issuance of long-term debt with embedded derivative
|
|
764
|
|
|
Change in fair value included in interest and other income, net
|
|
(294
|
)
|
|
Balance as of December 31, 2017
|
|
$
|
470
|
|
|
December 31, 2017
|
||||||||||||||
|
|
|
Gross Unrealized
|
|
Gross Unrealized
|
|
|
||||||||
|
Amortized Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt
|
$
|
23,507
|
|
|
$
|
—
|
|
|
$
|
(36
|
)
|
|
$
|
23,471
|
|
U.S. Treasury notes
|
61,777
|
|
|
—
|
|
|
(131
|
)
|
|
61,646
|
|
||||
Total
|
$
|
85,284
|
|
|
$
|
—
|
|
|
$
|
(167
|
)
|
|
$
|
85,117
|
|
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments
|
$
|
82,280
|
|
|
|
|
|
$
|
(154
|
)
|
|
$
|
82,126
|
|
|
Long-term investments
|
3,004
|
|
|
|
|
|
(13
|
)
|
|
2,991
|
|
||||
Total
|
$
|
85,284
|
|
|
$
|
—
|
|
|
$
|
(167
|
)
|
|
$
|
85,117
|
|
|
December 31, 2016
|
||||||||||||||
|
|
|
Gross Unrealized
|
|
Gross Unrealized
|
|
|
||||||||
|
Amortized Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt
|
$
|
51,354
|
|
|
$
|
—
|
|
|
$
|
(121
|
)
|
|
$
|
51,233
|
|
U.S. Treasury notes
|
61,048
|
|
|
5
|
|
|
(77
|
)
|
|
60,976
|
|
||||
Total
|
$
|
112,402
|
|
|
$
|
5
|
|
|
$
|
(198
|
)
|
|
$
|
112,209
|
|
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments
|
$
|
90,050
|
|
|
$
|
1
|
|
|
$
|
(134
|
)
|
|
$
|
89,917
|
|
Long-term investments
|
22,352
|
|
|
4
|
|
|
(64
|
)
|
|
22,292
|
|
||||
Total
|
$
|
112,402
|
|
|
$
|
5
|
|
|
$
|
(198
|
)
|
|
$
|
112,209
|
|
|
December 31, 2017
|
|
December 31, 2016
|
||||
Raw materials
|
$
|
859
|
|
|
$
|
—
|
|
Work-in-process
|
817
|
|
|
—
|
|
||
Finished goods
|
28
|
|
|
—
|
|
||
Total inventory
|
$
|
1,704
|
|
|
$
|
—
|
|
|
December 31, 2017
|
||
2018
|
$
|
3,782
|
|
2019
|
2,019
|
|
|
2020
|
591
|
|
|
2021
|
—
|
|
|
2022
|
—
|
|
|
Thereafter
|
—
|
|
|
Total
|
$
|
6,392
|
|
|
December 31, 2017
|
|
December 31, 2016
|
||||
Loans payable, gross
|
$
|
100,000
|
|
|
$
|
—
|
|
Less: Unamortized debt discount and issuance costs
|
(1,747
|
)
|
|
—
|
|
||
Plus: Unpaid portion of quarterly interest payment
|
4,394
|
|
|
—
|
|
||
Carrying value of loans payable
|
$
|
102,647
|
|
|
$
|
—
|
|
Less: Current portion of long-term debt
|
—
|
|
|
—
|
|
||
Non-current portion of long-term debt
|
$
|
102,647
|
|
|
$
|
—
|
|
|
December 31, 2017
|
|
December 31, 2016
|
||
Common stock awards issued and outstanding
|
5,564,635
|
|
|
5,483,557
|
|
Authorized for future issuance under 2014 Equity Incentive Plan
|
1,723,733
|
|
|
1,576,926
|
|
Authorized for future issuance under 2016 Inducement Plan
|
188,715
|
|
|
334,062
|
|
Employee stock purchase plan
|
693,856
|
|
|
532,849
|
|
Total
|
8,170,939
|
|
|
7,927,394
|
|
|
|
Outstanding Options
|
|
Weighted Average
Remaining
Contractual
Term (years)
|
|
Aggregate Intrinsic
Value
(thousands)
|
|||||||
|
|
Number of Shares
|
|
Weighted Average
Exercise
Price
|
|
|
|||||||
Stock Options
|
|
|
|
|
|||||||||
Balances, December 31, 2016
|
|
5,270,196
|
|
|
$
|
9.60
|
|
|
|
|
|
|
|
Options granted
|
|
1,444,675
|
|
|
18.87
|
|
|
|
|
|
|||
Options exercised
|
|
(1,183,353
|
)
|
|
7.63
|
|
|
|
|
|
|
||
Options forfeited
|
|
(383,243
|
)
|
|
16.42
|
|
|
|
|
|
|||
Options expired
|
|
(10,691
|
)
|
|
20.29
|
|
|
|
|
|
|||
Balances, December 31, 2017
|
|
5,137,584
|
|
|
$
|
12.12
|
|
|
6.48
|
|
$
|
111,981
|
|
Vested and expected to vest, December 31, 2017
|
|
4,991,486
|
|
|
$
|
11.99
|
|
|
6.43
|
|
$
|
109,438
|
|
Exercisable, December 31, 2017
|
|
3,363,191
|
|
|
$
|
9.01
|
|
|
5.31
|
|
$
|
83,688
|
|
|
|
Outstanding Units
|
|||||
|
|
|
|
Weighted-Average
Grant Date Fair Value |
|||
|
|
|
|
||||
Restricted Stock Units
|
|
Number of Shares
|
|
||||
Unvested, December 31, 2016
|
|
213,361
|
|
|
$
|
14.66
|
|
Granted
|
|
349,896
|
|
|
19.97
|
|
|
Vested
|
|
(64,471
|
)
|
|
14.96
|
|
|
Forfeited
|
|
(71,735
|
)
|
|
16.13
|
|
|
Unvested, December 31, 2017
|
|
427,051
|
|
|
$
|
18.72
|
|
|
Years Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Research and development
|
$
|
3,597
|
|
|
$
|
2,855
|
|
|
$
|
3,156
|
|
Selling, general and administrative
|
9,770
|
|
|
7,716
|
|
|
6,800
|
|
|||
Total stock-based compensation expense
|
$
|
13,367
|
|
|
$
|
10,571
|
|
|
$
|
9,956
|
|
•
|
The expected stock price volatility assumption was determined by examining the historical volatilities of a group of industry peers, as well as taking into consideration the Company’s own historical volatility since its IPO in 2014.
|
•
|
The risk-free interest rate is based on the U.S. Treasury zero-coupon issues with remaining terms similar to the expected term on the options.
|
•
|
The expected term of the options granted represents the average period the stock options are expected to remain outstanding. The Company has elected to use the “simplified method” for estimating the expected term, which is calculated as the mid-point between the vesting period and the contractual term of the options.
|
•
|
The expected dividend yield assumption was based on the Company’s historical and expectation of dividend payouts.
|
•
|
Determination of the fair value of the shares of common stock underlying the stock options historically has been the responsibility of the Company’s board of directors. Subsequent to the IPO in April 2014, the fair value of common stock is determined based on the closing price of the Nasdaq Global Market.
|
|
Years Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Stock Options
|
|
|
|
|
|
Expected price volatility
|
68% - 70%
|
|
69% - 71%
|
|
68% - 80%
|
Risk-free interest rate
|
1.83% - 2.17%
|
|
1.23% - 1.81%
|
|
1.37% - 1.95%
|
Expected term (in years)
|
5.50 - 6.25
|
|
5.50 - 6.25
|
|
5.50 - 6.25
|
Dividend yield
|
—
|
|
—
|
|
—
|
|
Years Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Employee Stock Purchase Plan
|
|
|
|
|
|
Expected price volatility
|
51% - 71%
|
|
68% - 73%
|
|
56% - 62%
|
Risk-free interest rate
|
0.60% - 1.45%
|
|
0.49% - 0.60%
|
|
0.07% - 0.41%
|
Expected term (in years)
|
0.50
|
|
0.50
|
|
0.50
|
Dividend yield
|
—
|
|
—
|
|
—
|
|
Years Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Expected price volatility
|
68% - 80%
|
|
71% - 77%
|
|
76% - 82%
|
Risk-free interest rate
|
1.94% - 2.36%
|
|
1.47% - 2.46%
|
|
1.84% - 2.26%
|
Expected term (in years)
|
6.00 - 9.75
|
|
7.00 - 9.75
|
|
8.00 - 9.00
|
Dividend yield
|
—
|
|
—
|
|
—
|
|
December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Current:
|
|
|
|
|
|
||||||
Federal
|
$
|
(1,730
|
)
|
|
$
|
(116
|
)
|
|
$
|
(5,273
|
)
|
State
|
—
|
|
|
1
|
|
|
1
|
|
|||
Foreign
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
(1,730
|
)
|
|
(115
|
)
|
|
(5,272
|
)
|
|||
Deferred:
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
—
|
|
|
—
|
|
|||
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Foreign
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
—
|
|
|
—
|
|
|
—
|
|
|||
Benefit for income taxes
|
$
|
(1,730
|
)
|
|
$
|
(115
|
)
|
|
$
|
(5,272
|
)
|
|
December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Statutory federal income tax rate
|
$
|
(31,927
|
)
|
|
$
|
(21,079
|
)
|
|
$
|
(19,976
|
)
|
State income taxes, net of federal tax benefits
|
(5,041
|
)
|
|
(9
|
)
|
|
1
|
|
|||
Foreign rate differential
|
—
|
|
|
10
|
|
|
—
|
|
|||
Tax credits
|
(2,306
|
)
|
|
(3,905
|
)
|
|
(8,303
|
)
|
|||
Impact of federal rate change
|
24,907
|
|
|
—
|
|
|
—
|
|
|||
Net operating loss carryback
|
—
|
|
|
—
|
|
|
4,099
|
|
|||
Change in statutory rates
|
(1,440
|
)
|
|
624
|
|
|
—
|
|
|||
Stock compensation
|
(2,558
|
)
|
|
(1,109
|
)
|
|
821
|
|
|||
State net operating losses
|
633
|
|
|
1,779
|
|
|
—
|
|
|||
Other
|
—
|
|
|
109
|
|
|
1,330
|
|
|||
Change in valuation allowance
|
16,002
|
|
|
23,465
|
|
|
16,756
|
|
|||
Income tax provision
|
$
|
(1,730
|
)
|
|
$
|
(115
|
)
|
|
$
|
(5,272
|
)
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Net operating loss carryforwards
|
$
|
44,177
|
|
|
$
|
29,102
|
|
Research and development tax credits
|
16,189
|
|
|
14,453
|
|
||
Accruals and reserves
|
371
|
|
|
395
|
|
||
Stock compensation
|
6,244
|
|
|
6,902
|
|
||
Depreciation and amortization
|
1,638
|
|
|
1,765
|
|
||
Total deferred tax assets
|
68,619
|
|
|
52,617
|
|
||
Less: Valuation allowance
|
(68,619
|
)
|
|
(52,617
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Balance at the beginning of the year
|
$
|
3,188
|
|
|
$
|
1,820
|
|
|
$
|
2,608
|
|
Additions based on prior period tax positions
|
43
|
|
|
93
|
|
|
980
|
|
|||
Additions based on current period tax positions
|
803
|
|
|
1,275
|
|
|
—
|
|
|||
Reductions based on prior period tax positions
|
—
|
|
|
—
|
|
|
(1,768
|
)
|
|||
Balance at the end of the year
|
$
|
4,034
|
|
|
$
|
3,188
|
|
|
$
|
1,820
|
|
|
December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Historical net loss per share
|
|
|
|
|
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net loss, basic and diluted
|
$
|
(89,490
|
)
|
|
$
|
(60,058
|
)
|
|
$
|
(51,802
|
)
|
Denominator:
|
|
|
|
|
|
||||||
Weighted average common shares outstanding, basic and diluted
|
22,558
|
|
|
21,711
|
|
|
18,116
|
|
|||
Less: weighted average unvested common shares subject to repurchase
|
—
|
|
|
—
|
|
|
(5
|
)
|
|||
Weighted average common shares used in calculating net loss per share, basic and diluted
|
22,558
|
|
|
21,711
|
|
|
18,111
|
|
|||
Net loss per share, basic and diluted
|
$
|
(3.97
|
)
|
|
$
|
(2.77
|
)
|
|
$
|
(2.86
|
)
|
|
December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Options to purchase common stock
|
5,940
|
|
|
5,523
|
|
|
5,249
|
|
Total
|
5,940
|
|
|
5,523
|
|
|
5,249
|
|
|
Year Ended December 31, 2017
|
||||||||||||||||||
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||||||
Total net revenues
|
$
|
—
|
|
|
|
$
|
2
|
|
|
|
$
|
1
|
|
|
|
$
|
568
|
|
(1)
|
Gross profit(2)
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
551
|
|
|
||||
Net loss
|
(16,028
|
)
|
|
|
(20,745
|
)
|
|
|
(23,360
|
)
|
|
|
(29,357
|
)
|
|
||||
Net loss per share, basic and diluted
|
(0.72
|
)
|
|
|
(0.93
|
)
|
|
|
(1.04
|
)
|
|
|
(1.27
|
)
|
|
|
Year Ended December 31, 2016
|
|
|||||||||||||||||
|
First Quarter
|
|
Second Quarter
|
|
Third Quarter
|
|
Fourth Quarter
|
||||||||||||
Total net revenues
|
$
|
175
|
|
|
|
$
|
222
|
|
|
|
$
|
138
|
|
|
|
$
|
37
|
|
|
Gross profit
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
||||
Net loss
|
(13,828
|
)
|
|
|
(16,876
|
)
|
|
|
(14,394
|
)
|
|
|
(14,960
|
)
|
|
||||
Net loss per share, basic and diluted
|
(0.65
|
)
|
|
|
(0.78
|
)
|
|
|
(0.66
|
)
|
|
|
(0.68
|
)
|
|
(1)
|
In the fourth quarter of 2017 the Company commenced commercial sales of GOCOVRI.
|
(2)
|
Gross profit is computed by subtracting cost of product sales from product sales, net.
|
•
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
|
•
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
|
•
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
|
Exhibit
Number
|
|
|
|
Incorporation By Reference
|
|
|
||||||
|
Exhibit Description
|
|
Form
|
|
SEC File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated Certificate of Incorporation of Adamas Pharmaceuticals, Inc.
|
|
8-K
|
|
001-36399
|
|
3.1
|
|
4/15/2014
|
|
|
|
|
Amended and Restated Bylaws of Adamas Pharmaceuticals, Inc.
|
|
S-1
|
|
333-194342
|
|
3.4
|
|
3/5/2014
|
|
|
|
4.1
|
|
Reference is made to Exhibits 3.1 through 3.2.
|
|
|
|
|
|
|
|
|
|
|
|
Form of Common Stock Certificate of Adamas Pharmaceuticals, Inc.
|
|
S-1
|
|
333-194342
|
|
4.1
|
|
3/26/2014
|
|
|
|
|
Fourth Amended and Restated Investor Rights Agreement, dated as of September 30, 2011, by and among the registrant and certain of its stockholders.
|
|
S-1
|
|
333-194342
|
|
10.5
|
|
3/5/2014
|
|
|
|
|
Adamas Pharmaceuticals, Inc. 2002 Employee, Director and Consultant Stock Plan, as amended, and Form of Stock Option Grant Notice, Option Agreement and Form of Notice of Exercise.
|
|
S-1
|
|
333-194342
|
|
10.1
|
|
3/5/2014
|
|
|
|
|
Adamas Pharmaceuticals, Inc. 2007 Stock Plan, as amended, and Form of Stock Option Grant Notice, Option Agreement and Form of Notice of Exercise.
|
|
S-1
|
|
333-194342
|
|
10.2
|
|
3/5/2014
|
|
|
|
|
Adamas Pharmaceuticals, Inc. 2014 Equity Incentive Plan and Form of Stock Option Grant Notice and Option Agreement.
|
|
S-1
|
|
333-194342
|
|
10.3
|
|
4/7/2014
|
|
|
|
|
Adamas Pharmaceuticals, Inc. Form of Stock Option Grant Notice and Option Agreement.
|
|
10-Q
|
|
001-36399
|
|
10.24
|
|
8/11/2015
|
|
|
|
|
Adamas Pharmaceuticals, Inc. 2014 Employee Stock Purchase Plan.
|
|
S-1
|
|
333-194342
|
|
10.4
|
|
3/26/2014
|
|
|
Exhibit
Number
|
|
|
|
Incorporation By Reference
|
|
|
||||||
|
Exhibit Description
|
|
Form
|
|
SEC File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adamas Pharmaceuticals, Inc. Form of Restricted Stock Unit Grant Notice and Award Agreement.
|
|
10-K
|
|
001-36399
|
|
10.24
|
|
2/23/2016
|
|
|
|
|
Adamas Pharmaceuticals, Inc. Amended and Restated 2016 Inducement Plan.
|
|
S-8
|
|
333-216313
|
|
99.5
|
|
2/28/2017
|
|
|
|
|
Form of Restricted Stock Unit Grant Notice and Award Agreement under the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan.
|
|
S-8
|
|
333-194342
|
|
99.6
|
|
3/17/2016
|
|
|
|
|
Form of Stock Option Grant Notice and Option Agreement under the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan.
|
|
S-8
|
|
333-194342
|
|
99.7
|
|
3/17/2016
|
|
|
|
|
Office Lease Agreement by and between the registrant and CA-Emeryville Properties Limited Partnership, dated as of October 25, 2006.
|
|
S-1
|
|
333-194342
|
|
10.7
|
|
3/5/2014
|
|
|
|
|
First Amendment to Lease by and between the registrant and NOP Watergate LLC (as successor in interest to CA-Emeryville Properties Limited Partnership), dated as of April 29, 2009.
|
|
S-1
|
|
333-194342
|
|
10.8
|
|
3/5/2014
|
|
|
|
|
Second Amendment to Office lease Agreement by and between the registrant and Emeryville Office, L.L.C. (as successor to NOP Watergate, LLC), dated as of January 18, 2011.
|
|
S-1
|
|
333-194342
|
|
10.9
|
|
3/5/2014
|
|
|
|
|
Third Amendment to Lease by and between the registrant and Emeryville Office, L.L.C., dated as of June 17, 2011.
|
|
S-1
|
|
333-194342
|
|
10.10
|
|
3/5/2014
|
|
|
|
|
Fourth Amendment to Lease by and between the registrant and Emeryville Office, L.L.C., dated as of January 31, 2013.
|
|
S-1
|
|
333-194342
|
|
10.11
|
|
3/5/2014
|
|
|
|
|
Fifth Amendment to Lease by and between the registrant and Emeryville Office, L.L.C., dated as of May 23, 2014.
|
|
10-Q
|
|
001-36399
|
|
10.3
|
|
8/7/2014
|
|
|
|
|
Sixth Amendment to Lease by and between the registrant and KBSIII Towers At Emeryville, LLC, dated as of October 27, 2015.
|
|
10-K
|
|
001-36399
|
|
10.23
|
|
2/23/2016
|
|
|
|
|
License Agreement by and between the registrant and Forest Laboratories Holdings Limited, dated as of November 13, 2012.
|
|
S-1/A
|
|
333-194342
|
|
10.6
|
|
4/7/2014
|
|
|
|
|
Adamas Pharmaceuticals, Inc. Amended and Restated Executive Severance Plan.
|
|
10-Q
|
|
001-36399
|
|
10.2
|
|
5/9/2017
|
|
|
|
|
Offer Letter by and between Adamas Pharmaceuticals, Inc. and Gregory Went, dated as of March 8, 2006.
|
|
S-1
|
|
333-194342
|
|
10.12
|
|
3/5/2014
|
|
|
Exhibit
Number
|
|
|
|
Incorporation By Reference
|
|
|
||||||
|
Exhibit Description
|
|
Form
|
|
SEC File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Offer Letter by and between registrant and William J. Dawson, dated as of August 12, 2014.
|
|
8-K
|
|
001-36399
|
|
10.8
|
|
8/13/2014
|
|
|
|
|
Offer letter by and between the registrant and Rajiv Patni, MD, dated April 17, 2015.
|
|
10-Q
|
|
001-36399
|
|
10.23
|
|
8/11/2015
|
|
|
|
|
Offer letter by and between the registrant and Jennifer Rhodes, dated March 25, 2016.
|
|
10-Q
|
|
001-36399
|
|
10.1
|
|
5/10/2016
|
|
|
|
|
Form of Indemnity Agreement between the registrant and its directors and officers.
|
|
S-1
|
|
333-194342
|
|
10.17
|
|
3/5/2014
|
|
|
|
|
2016 Executive Cash Bonus Award Program.
|
|
10-Q
|
|
001-36399
|
|
10.2
|
|
5/10/2016
|
|
|
|
|
2017 Executive Cash Bonus Award Program.
|
|
8-K
|
|
001-36399
|
|
10.1
|
|
4/5/2017
|
|
|
|
|
Consulting Services Agreement by and between the registrant and John MacPhee, M.P.H., dated February 1, 2016, and as amended dated August 5, 2016.
|
|
10-Q
|
|
001-36399
|
|
10.1
|
|
11/3/2016
|
|
|
|
|
Compensatory Arrangements with Non-Employee Directors.
|
|
10-K
|
|
001-36399
|
|
10.27
|
|
2/28/2017
|
|
|
|
|
Offer letter by and between the registrant and Richard A. King, dated April 17, 2017.
|
|
10-Q
|
|
001-36399
|
|
10.1
|
|
8/8/2017
|
|
|
|
|
Offer letter by and between the registrant and Alfred G. Merriweather, dated June 26, 2017.
|
|
10-Q
|
|
001-36399
|
|
10.2
|
|
8/8/2017
|
|
|
|
|
Separation agreement by and between the registrant and William Dawson, dated June 27, 2017.
|
|
10-Q
|
|
001-36399
|
|
10.3
|
|
8/8/2017
|
|
|
|
|
Loan Agreement dated May 11, 2017 between Adamas Pharma, LLC and Healthcare Royalty Partners III, L.P.
|
|
10-Q
|
|
001-36399
|
|
10.4
|
|
8/8/2017
|
|
|
|
|
Secured Promissory Note dated May 11, 2017 between Adamas Pharma, LLC and Healthcare Royalty Partners III, L.P.
|
|
10-Q
|
|
001-36399
|
|
10.5
|
|
8/8/2017
|
|
|
|
|
Amended and Restated Commercial Supply Agreement by and between Adamas Pharmaceuticals, Inc. and Catalent Pharma Solutions, LLC.
|
|
10-Q
|
|
001-36399
|
|
10.1
|
|
11/2/17
|
|
|
|
|
Amended and Restated API Supply Agreement by and between Adamas Pharma, LLC and Moehs Ibérica, S.L.
|
|
10-Q
|
|
001-36399
|
|
10.2
|
|
11/2/17
|
|
|
|
|
2017 compensation actions with respect to the CEO and CFO.
|
|
8-K
|
|
001-36399
|
|
Item 5.02
|
|
2/27/2017
|
|
|
|
|
Change in Compensation for Christopher B. Prentiss, Chief Accounting Officer.
|
|
8-K
|
|
001-36399
|
|
Item 5.02
|
|
9/21/2017
|
|
|
|
|
Secured Promissory Note dated November 27, 2017 between Adamas Pharma, LLC and Healthcare Royalty Partners III, L.P.
|
|
|
|
|
|
|
|
|
|
X
|
Exhibit
Number
|
|
|
|
Incorporation By Reference
|
|
|
||||||
|
Exhibit Description
|
|
Form
|
|
SEC File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Seventh Amendment to Lease by and between the registrant and KBSIII Towers At Emeryville, LLC, dated as of January 16, 2018.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
Consent of Independent Registered Public Accounting Firm.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
Power of Attorney (included on the signature page hereto).
|
|
|
|
|
|
|
|
|
|
X
|
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.(1).
|
|
|
|
|
|
|
|
|
|
X
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
(1)
|
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
|
|
|
Adamas Pharmaceuticals, Inc.
(Registrant)
|
Date:
|
February 22, 2018
|
/s/ Gregory T. Went, Ph.D.
|
|
|
Gregory T. Went, Ph.D.
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date:
|
February 22, 2018
|
/s/ Alfred G. Merriweather
|
|
|
Alfred G. Merriweather
Chief Financial Officer
(Principal Financial Officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Gregory T. Went
|
|
Chief Executive Officer and Chairman
|
|
February 22, 2018
|
Gregory T. Went, Ph.D.
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Alfred G. Merriweather
|
|
Chief Financial Officer
|
|
February 22, 2018
|
Alfred G. Merriweather
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/ Christopher B. Prentiss
|
|
Chief Accounting Officer
|
|
February 22, 2018
|
Christopher B. Prentiss
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Michael Bigham
|
|
Director
|
|
February 22, 2018
|
Michael Bigham
|
|
|
|
|
|
|
|
|
|
/s/ Martha J. Demski
|
|
Director
|
|
February 22, 2018
|
Martha J. Demski
|
|
|
|
|
|
|
|
|
|
/s/ Mardi C. Dier
|
|
Director
|
|
February 22, 2018
|
Mardi C. Dier
|
|
|
|
|
|
|
|
|
|
/s/ William Ericson
|
|
Director
|
|
February 22, 2018
|
William Ericson
|
|
|
|
|
|
|
|
|
|
/s/ Ivan Lieberburg
|
|
Director
|
|
February 22, 2018
|
Ivan Lieberburg, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/ John MacPhee
|
|
Director
|
|
February 22, 2018
|
John MacPhee
|
|
|
|
|
|
|
|
|
|
/s/ David L. Mahoney
|
|
Director
|
|
February 22, 2018
|
David L. Mahoney
|
|
|
|
|
$65,000,000.00
|
Dated: November 27, 2017
|
|
BORROWER:
|
|
||
|
ADAMAS PHARMA, LLC
|
|
||
|
|
|
|
|
|
By:
|
ADAMAS PHARMACEUTICALS, INC., its manager
|
|
|
|
|
|
|
|
|
By:
|
/s/ Gregory T. Went
|
|
|
|
|
Name:
|
Gregory T. Went
|
|
|
|
Title:
|
Chief Executive Officer
|
|
Date
|
|
Principal
Amount
|
|
Interest
|
|
Payment Amount
|
|
Notation By
|
|
|
|
|
|
|
|
|
|
(D)
|
FDA Approval has occurred.
|
|
“Borrower”
|
|
||
|
ADAMAS PHARMA, LLC
|
|
||
|
|
|
|
|
|
By:
|
Adamas Pharmaceuticals, Inc.,
|
|
|
|
|
its manager
|
|
|
|
|
|
|
|
|
By:
|
/s/ Gregory T. Went
|
|
|
|
|
Name:
|
Gregory T. Went
|
|
|
|
Title:
|
Chief Executive Officer
|
|
Months*
|
Monthly Installment of Base Rent
|
1 - 12
|
$159,910.50**
|
13 - 24
|
$164
,
707.80
|
25 - 36
|
$169,649.05
|
37 - 48
|
$174,738.52
|
49 - 60
|
$179,980.68
|
61 - 72
|
$185,380.10
|
73 - 84
|
$190,941.50
|
85 - 4/30/2025
|
$196,669.75
|
|
Landlord’s Notice Address:
|
KBSIII Towers At Emeryville, LLC
c/o KBS Capital Advisors, LLC
800 Newport Center Drive, Suite 700 Newport Beach, CA 92660
|
|
With a copy to:
|
Attn: General Counsel
KBSIII Towers At Emeryville, LLC
c/o KBS Capital Advisors, LLC
800 Newport Center Drive, Suite 700 Newport Beach, CA 92660
Attn: Brent Carroll, Asset Manager
|
|
Landlord’s Address for Payment of Rent:
|
KBSIII Towers At Emeryville, LLC
c/o P.O. Box 740499
Los Angeles, CA 90074-0499
|
|
For payment of Parking Charges:
|
LAZ Parking
2000 Powell Street, Suite 100
Emeryville, CA 94608
|
A.
|
Section 1l.02(c)
of the Original Lease is changed to read: (c) in the event of an assignment of the Lease requiring Landlord’s consent or subletting of more than 20% of the Rentable Square Footage of the Premises for substantially the remaining term of the Lease (excluding unexercised options), recapture the portion of the Premises Tenant is proposing to Transfer.
|
B.
|
Exhibit B
of the Original Lease
Sec
t
ion 2.01(b)
is changed to add “not to exceed 3% of Rent”.
|
C.
|
Exhibit B
of the Original Lease Section 2.0l(g) is changed to add after the word “deductibles” the following: “(provided, however, that Tenant’s Pro Rata Share
of
any
earthquake deductible shall be amortized over the useful life of the
improvements constructed with such earthquake insurance proceeds”).
|
By:
|
/s/ Alfred G. Merriweather
|
Name:
|
Alfred G. Merriweather
|
Its:
|
CFO
|
By:
|
KBS Capital Advisors, LLC
|
|
|
a Delaware limited liability company
|
|
|
Its: Authorized Agent
|
|
|
|
|
|
By:
|
/s/ Brent Carroll
|
|
Name:
|
Brent Carroll
|
|
Title:
|
Senior Vice President
|
|
Date signed:
|
1/16/18
|
1.
|
I have reviewed this annual report on Form 10-K of Adamas Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and
|
b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated:
|
February 22, 2018
|
/s/ Gregory T. Went, Ph.D.
|
|
|
Gregory T. Went, Ph.D.
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this annual report on Form 10-K of Adamas Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
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designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
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a)
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all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and
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b)
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Dated:
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February 22, 2018
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/s/ Alfred G. Merriweather
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Alfred G. Merriweather
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Chief Financial Officer
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(Principal Financial Officer)
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1.
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The Company’s Annual Report on Form 10-K for the period ended
December 31, 2017
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
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2.
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The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Gregory T. Went, Ph.D.
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/s/ Alfred G. Merriweather
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Gregory T. Went, Ph.D.
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Alfred G. Merriweather
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Chief Executive Officer
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Chief Financial Officer
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(Principal Executive Officer)
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(Principal Financial Officer)
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