x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2011
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OR
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o
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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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13-3831168
(I.R.S. Employer Identification Number)
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15 Skyline Drive
Hawthorne, New York 10532
(914) 347-4300
(Address, including zip code, and telephone number,
including area code, of registrant's principal executive offices)
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Securities registered pursuant to Section 12(b) of the Act:
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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 $0.001 par value
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NASDAQ Global Market
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Securities registered pursuant to Section 12(g) of the Act: None
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Large accelerated filer
x
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Accelerated filer
o
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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Page
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Ampyra
: Ampyra (dalfampridine) Extended Release Tablets, 10mg was approved by the FDA in January 2010 for the improvement of walking in people with MS. This was demonstrated by an increase in walking speed. To our knowledge, Ampyra is the first and only product indicated to improve walking in people with MS. Ampyra was made commercially available in the U.S. in March 2010, using our own specialty sales force, and had net revenue of $210.5 million for the year ended December 31, 2011, with approximately 19,000 new patients trying Ampyra therapy in 2011. Approximately 30% of all eligible MS patients have tried Ampyra since the 2010 launch. As of December 31, 2011, approximately 70% of all people with MS who were prescribed Ampyra received a first refill, and approximately 40% of all people with MS who were prescribed Ampyra received a sixth refill. Compliance rates for Ampyra are approximately 90%, with patients currently taking an average of 1.8 tablets per day, compared to the approved dosing of 2 tablets per day. We are also studying the potential for dalfampridine to be applied to other indications within MS and to other neurological conditions. In December 2011, we initiated a Phase 2 proof-of-concept clinical study of dalfampridine in adults with cerebral palsy. We plan to begin a Phase 2 proof-of-concept clinical study of dalfampridine in chronic stroke patients in the second half of 2012. Investigator-initiated studies are exploring potential additional therapeutic applications of dalfampridine.
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·
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Ampyra Patents:
In August 2011, the U.S. Patent and Trademark Office, or USPTO, issued one of our Ampyra patent applications and allowed another. The USPTO determined that the issued patent will extend into 2027 with final patent term adjustment calculation. The patent that issues from the allowed patent application is expected to expire in 2025 plus any additional term determined by the final patent term adjustment calculation by the USPTO, which may extend the term of the patent into 2026. In June 2011, the European Patent Office, or EPO, issued a patent from our EPO patent application that corresponds to our patent application allowed by the USPTO in August 2011.
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·
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Fampyra/Biogen:
Ampyra is marketed as Fampyra outside the U.S. by Biogen Idec under a 2009 license and collaboration agreement. In July 2011, Biogen Idec received conditional approval from the European Commission for Fampyra (prolonged-release fampridine tablets) for the improvement of walking in adult patients with MS with walking disability (Expanded Disability Status Scale of 4-7). To date, Biogen Idec has launched Fampyra in Germany, the United Kingdom, Denmark, Norway and Iceland. Launch in most of the remaining EU countries is expected by the end of 2012. In May 2011, Fampyra was approved for use in Australia by the Australian Therapeutic Goods Administration, and has been launched there. In November 2011, Biogen Idec received approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE), and in February 2012 Biogen Idec received approval from Health Canada. Biogen Idec plans to submit regulatory filings for Fampyra in more than 20 countries in 2012.
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·
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Zanaflex Capsules and Zanaflex tablets:
Our Zanaflex Capsules, which we launched in April 2005, and Zanaflex tablets, which we also sell, are FDA-approved as short-acting drugs for the management of spasticity, a symptom of many CNS disorders, including MS and SCI. These products contain tizanidine hydrochloride, one of the two leading drugs used to treat spasticity. In February 2012, the FDA approved an Abbreviated New Drug Application, or ANDA, filed by Apotex Corp. and Apotex Inc. (“Apotex”) with respect to a generic version of tizanidine hydrochloride capsules. On February 6, 2012, Apotex launched generic tizanidine hydrochloride capsules, and we launched an authorized generic version of Zanaflex Capsules under our agreement with Watson Pharma, Inc., a subsidiary of Watson Pharmaceuticals, Inc.
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·
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Research and Development Programs:
We have three ongoing research and development programs – neuregulins, remyelinating antibodies and chondroitinase – focused on novel approaches to limit and repair damage to components of the CNS. In addition, in 2011, we in-licensed a clinical-stage program, AC105, to develop an acute treatment for neurological trauma.
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o
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Neuregulins:
GGF2 is our lead product candidate for our neuregulins program. We commenced a Phase 1 clinical trial of GGF2 in heart failure patients in December 2010, and the clinical trial is ongoing. We plan to announce initial study results in the second half of 2012. If we are able to establish a proof of concept for treatment of heart failure through human clinical studies, we may decide to develop the product either by entering into a partnership, most likely with a cardiovascular-focused company, or by developing it on our own. We also are continuing with research on potential neurology indications for GGF2.
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o
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Remyelinating Antibodies:
rHIgM22 is the lead antibody in our remyelinating antibody program, and we are developing it as a potential therapeutic for MS. We expect to file an IND for rHIgM22 for the treatment of MS in the first half of 2012, and to begin a Phase 1 clinical trial by the end of 2012. We believe a therapy, such as this antibody, that could repair myelin sheaths has the potential to restore substantial neurological function to those affected by demyelinating conditions.
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o
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AC105:
In June 2011, we entered into a license agreement with Medtronic, Inc. and one of its affiliates pursuant to which we licensed from them worldwide development and commercialization rights to certain formulations of magnesium with a polymer such as polyethylene glycol, which we refer to as AC105. We plan to study AC105 as an acute treatment for patients who have suffered neurological trauma, such as SCI and traumatic brain injury, or TBI, and we expect to begin a Phase 2 clinical trial in patients with acute SCI in the second half of 2012. AC105 has been shown to reduce lesion size and enhance recovery in animal models of SCI. AC105 has been shown to be safe and tolerable in a small number of healthy normal subjects in Phase 1 human trials.
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·
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Neuronex Merger Agreement:
On February 15, 2012, we entered into a merger agreement with Neuronex, Inc., a privately-held development stage pharmaceutical company. Neuronex is preparing a 505(b)(2) type New Drug Application, or NDA, for a proprietary nasal spray formulation of Diazepam, or DZNS, as a rescue treatment for certain epilepsy patients. The NDA will provide pharmacokinetic data with the nasal spray and reference older investigations on efficacy and safety for Diastat AcuDial (diazepam rectal gel), a rectally-administered diazepam formulation. Completion of the acquisition is subject to specified conditions and termination rights. This acquisition would provide a near-term commercial opportunity in neurology that would leverage our experience in developing neurological products and, if the DZNS product is approved for sale, our existing commercial infrastructure. Under the terms of the merger agreement, we made an upfront payment of $2.0 million and paid $500,000 of a pre-closing research funding commitment of up to $1.2 million to prepare for a DZNS pre-NDA meeting with the FDA. Following the pre-NDA meeting, we can, at our option, complete the acquisition by paying an additional $6.8 million. If the acquisition is completed, we will assume oversight and financial responsibility for all future development and regulatory programs for DZNS. We expect that these expenses would not exceed $8 million in 2012. If we complete the acquisition, there are potential earnout payments to the former owners of Neuronex of up to $18 million based upon the
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|
achievement of specified regulatory and manufacturing-related milestones. If we complete the acquisition and DZNS is approved by the FDA, the former owners of Neuronex will also be entitled to receive milestone and royalty-like earnout payments from us based on net sales. Also, there are potential payments to SK Biopharmaceuticals Co., Ltd., or SK – the company that licenses the patent and other rights related to the DZNS product to Neuronex – and if we complete the acquisition we will be responsible for these payments. These payments include up to $8 million upon the achievement of specified development milestones (including $1 million upon FDA acceptance of the first NDA for the DZNS product), up to $3 million upon the achievement of specified sales milestones, and a tiered, mid-single digit royalty based on net sales. The structure of the deal enables us to make measured investments in the DZNS product through its development and regulatory review phases, with the majority of milestone payments to follow approval, if obtained.
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·
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Corporate Headquarters:
In June 2011, we announced that we signed an agreement to lease approximately 138,000 square feet of office and laboratory space within the Ardsley Park life science campus in Ardsley, N.Y. for a 15 year period expected to begin in June 2012. We also announced that we plan to relocate our corporate headquarters, and all employees currently based at our Hawthorne, N.Y. location, to the Ardsley facility. We have grown substantially over the last several years, and the new facility will provide state-of-the art office and laboratory space that will accommodate our current needs and allow for future growth.
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·
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Corporate Update:
In January 2012, General Counsel Jane Wasman, J.D., was named Chief, Strategic Development. In this new role, Ms. Wasman will assume additional responsibilities for overseeing the development and execution of our long-range strategic plans and objectives. She will continue to serve as our General Counsel. Also, in October 2011, Enrique Carrazana, M.D., joined us as our Chief Medical Officer
.
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·
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Continue to invest in growing Ampyra sales, with focus in 2012 on sales and marketing programs that increase awareness and use in patients with earlier stages of walking disability who can benefit from Ampyra. We also plan to continue to focus on educating prescribers of the value of Ampyra to earlier-stage patients, and to expand our reimbursement specialist programs, which provide assistance to physicians’ offices in navigating managed care challenges.
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·
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Work to expand our Ampyra franchise by assessing additional potential uses of dalfampridine in MS and possibly other neurological conditions such as cerebral palsy and chronic stroke.
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Support the efforts of our collaboration partner, Biogen Idec, in seeking health authority approval for and commercializing Fampyra in markets outside the U.S.
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·
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Advance our pipeline of research and development programs, and for 2012 in particular: advance GGF2 through its ongoing Phase 1 trial; advance AC105 into a Phase 2 clinical trial in patients with acute SCI; and advance rHIgM22 into a Phase 1 clinical trial.
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·
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Expand our pipeline through the potential in-licensing and/or acquisition of select products and technologies in neurology, with our focus through 2012 on commercial or near commercial opportunities.
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Commercial Products
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Indication
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Status
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Marketing Rights
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|||
Ampyra
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MS
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FDA-approved and marketed in the U.S.
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Acorda (U.S.)
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|||
Fampyra
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MS
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Approved in EU (conditional), Australia, Canada, and New Zealand; launched in Germany, U.K. and a number of other EU countries and in Australia
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Biogen Idec (outside U.S.)
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Zanaflex Capsules
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Spasticity
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FDA-approved
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Acorda (U.S.)
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Zanaflex tablets
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Spasticity
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FDA-approved
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Acorda (U.S.)
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Research and Development Programs
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Proposed Therapeutic Area(s)
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Stage of Development
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Marketing Rights
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Dalfampridine
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Cerebral Palsy
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Phase 2 proof-of-concept clinical trial commenced December 2011
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Acorda (U.S.)
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Dalfampridine
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Chronic Stroke
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Phase 2 proof-of-concept clinical trial expected to begin H2 2012
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Acorda (U.S.)
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AC105
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SCI and TBI
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Acute SCI Phase 2 clinical trial expected to begin in H2 2012
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Acorda/Worldwide
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Neuregulin Program
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Heart failure*
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GGF2 Phase 1 clinical trial ongoing; initial results expected H2 2012
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Acorda/Worldwide
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Remyelinating Antibodies Program
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MS
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rHIgM22 IND filing expected H1 2012; Phase 1 clinical trial expected to begin in H2 2012
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Acorda/Worldwide
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Chondroitinase Program
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SCI
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Research
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Acorda/Worldwide
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·
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Specialty Sales Force.
We employ a field-based team of highly experienced sales professionals to call primarily on neurologists and on other specialists and prescribers treating patients with MS, as well as other conditions that involve spasticity.
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·
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Managed Markets Team.
We employ a field-based team responsible for payer strategy, as well as contracting and account management of managed care organizations, pharmacy benefit managers, Medicaid agencies, specialty pharmacies, wholesale drug distribution customers, the Veterans Affairs institutions and the DOD military treatment facilities.
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preclinical laboratory and animal tests;
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submission to the FDA of an Investigational New Drug, or IND, an application which must become effective before human clinical trials may begin;
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completion of at least two adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed pharmaceutical in our intended use(s);
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FDA review of whether each facility in which the product is manufactured, processed, packed or held meets standards designed to assure the product's continued quality; and
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submission to the FDA of a New Drug Application, or NDA, in the case of a drug, or a Biologics License Application, or BLA, in the case of a biologic, that must be approved containing preclinical and clinical data, proposed labeling and information to demonstrate that the product will be manufactured to appropriate standards.
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Phase 1.
The drug is initially administered into healthy human subjects or subjects with the target condition and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.
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Phase 2.
The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
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Phase 3.
When Phase 2 evaluations demonstrate that a dosage range of the drug is effective and has an acceptable safety profile, Phase 3 clinical trials are undertaken to confirm the clinical efficacy from Phase 2 and to further test for safety in an expanded population at geographically dispersed clinical trial sites.
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Increasing our sales levels for Ampyra in the U.S. and supporting Biogen Idec’s efforts to successfully obtain and maintain regulatory approval for Fampyra (as Fampridine Prolonged Release tablets) in the EU and other markets outside the U.S.;
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expanding the Ampyra franchise through additional patent protection for Ampyra, new formulations, and additional indications in MS and possibly other neurological conditions such as cerebral palsy and chronic stroke
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continuing to advance clinical development of our AC105 and GGF2 programs, and advance rHIgM22 into clinical trials;
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continuing to develop our preclinical product candidates and advance them into clinical trials; and
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evaluating and potentially expanding our product development pipeline through the potential in-licensing and/or acquisition of additional products and technologies.
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the effectiveness of our sales, managed markets and marketing efforts;
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the acceptance of Ampyra in the medical community, particularly with respect to whether physicians and patients view Ampyra as safe and effective for its labeled indication, and whether it has an acceptable benefit-to-risk profile;
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the availability of adequate reimbursement by third-party payers;
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the continued use of compounded dalfampridine, instead of Ampyra, available through pharmacies in the U.S. and elsewhere that engage in compounding;
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the occurrence of any side effects, adverse reactions or misuse (or any unfavorable publicity relating thereto) stemming from the use of Ampyra; and
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the development of competing products or therapies for the treatment of MS or its symptoms.
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sales of Ampyra may be significantly decreased from projected sales;
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regulatory approvals for Ampyra may be restricted or withdrawn;
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we may decide to, or be required to, send product warning letters or field alerts to physicians, pharmacists and hospitals;
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reformulation of the product, additional preclinical or clinical studies, changes in labeling or changes to or reapprovals of manufacturing facilities may be required;
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our reputation in the marketplace may suffer; and
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government investigations and lawsuits, including class action suits, may be brought against us.
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not provide us with accurate or timely information regarding their inventories, the number of patients who are using Ampyra, Ampyra adverse events, or Ampyra complaints;
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not effectively sell or support Ampyra;
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reduce their efforts or discontinue selling or supporting Ampyra;
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not devote the resources necessary to sell Ampyra in the volumes and within the time frames that we expect;
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be unable to satisfy financial obligations to us or others;
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not have the required licenses to distribute drugs; or
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cease operations.
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we may not be able to control the amount and timing of resources that our collaborators devote to the development or commercialization of product candidates or to their marketing and distribution;
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collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all;
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disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management's attention and resources;
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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
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business combinations or significant changes in a collaborator's business strategy may also adversely affect a collaborator's willingness or ability to complete its obligations under any arrangement;
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a collaborator could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors;
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the collaborations may be terminated or allowed to expire, which would delay the development and may increase the cost of developing our product candidates; and
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collaborators may experience financial difficulties.
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negative or ambiguous results regarding the efficacy of the product candidate;
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undesirable side effects that delay or extend the trials, or other unforeseen or undesirable safety issues that make the product candidate not medically or commercially viable;
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inability to locate, recruit and qualify a sufficient number of patients for our trials;
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difficulty in determining meaningful end points or other measurements of success in our clinical trials;
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regulatory delays or other regulatory actions, including changes in regulatory requirements;
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difficulties in obtaining sufficient quantities of our product candidates manufactured under current good manufacturing practices;
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delays, suspension or termination of the trials imposed by us, an independent institutional review board for a clinical trial site, or clinical holds placed upon the trials by the FDA;
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FDA approval of new drugs that are more effective than our product candidates;
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change in the focus of our development efforts or a re-evaluation of our clinical development strategy; and
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change in our financial position.
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rate of adoption by healthcare practitioners;
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rate of a product’s acceptance by the target population,
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timing of market entry relative to competitive products,
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availability of alternative therapies,
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perceived advantages of alternative therapies,
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price of product relative to alternative therapies,
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extent of marketing efforts,
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unavailability of adequate reimbursement by third parties, and
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side effects or unfavorable publicity concerning the products or similar products.
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substantial cash expenditures;
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potentially dilutive issuance of equity securities;
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incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;
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difficulties in assimilating the operations of the acquired companies;
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diverting our management’s attention away from other business concerns;
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entering markets in which we have limited or no direct experience; and
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potential loss of our key employees or key employees of the acquired companies or businesses.
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voluntary or mandatory recalls;
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voluntary or mandatory patient or physician notification;
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withdrawal of product approvals;
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product seizures;
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restrictions on, or prohibitions against, marketing our products;
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restrictions on importation of our product candidates;
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fines and injunctions;
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civil and criminal penalties;
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exclusion from participation in government programs; and
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suspension of review or refusal to approve pending applications.
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pay substantial damages;
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stop using our technologies;
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withdraw a product from the market;
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stop certain research and development efforts;
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significantly delay product commercialization activities;
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develop non-infringing products or methods, which may not be feasible; and
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obtain one or more licenses from third parties.
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achievement or rejection of regulatory approvals by us or our collaborators or by our competitors;
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publicity regarding actual or potential clinical trial results or updates relating to products under development by us, our collaborators, or our competitors;
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announcements of new corporate partnerships, alliances, financings or other transactions, or of technological innovations or new commercial products by our competitors or by us;
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developments concerning proprietary rights, including patents;
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developments concerning our collaborations;
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economic or other crises or other external factors;
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conditions or trends in the pharmaceutical or biotechnology industries;
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litigation and other developments relating to our patents or other proprietary rights or those of our collaborators or competitors;
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governmental regulation and legislation in the U.S. and foreign countries;
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changes in securities analysts' estimates of our performance or our failure to meet analysts' expectations;
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sales of substantial amounts of our stock;
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delay or failure in initiating, completing or analyzing pre-clinical trials or unsatisfactory design or result of these trials;
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variations in product revenue and profitability;
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variations in our anticipated or actual operating results; and
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changes in healthcare reimbursement policies.
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Our board of directors has the right 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.
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Our board of directors may issue, without stockholder approval, shares of preferred stock with rights, preferences and privileges determined by the board of directors. The ability to authorize and issue preferred stock with voting or other rights or preferences makes it possible for our board of directors to issue preferred stock with super voting, special approval, dividend or other rights or preferences on a discriminatory basis that could impede the success of any attempt to acquire us.
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Our board of directors is divided into three classes, each with staggered three-year terms. As a result, only one class of directors will be elected at each annual meeting of stockholders, and each of the two other classes of directors will continue to serve for the remainder of their respective three-year terms, limiting the ability of stockholders to reconstitute the board of directors.
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The vote of the holders of 75% of the outstanding shares of our common stock is required in order to take certain actions, including amendment of our bylaws, removal of directors for cause and certain amendments to our certificate of incorporation.
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High
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Low
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|||||||
Fiscal Year Ended December 31, 2011
|
||||||||
Fourth Quarter
|
$ | 24.08 | $ | 18.36 | ||||
Third Quarter
|
$ | 32.66 | $ | 19.77 | ||||
Second Quarter
|
$ | 33.48 | $ | 20.90 | ||||
First Quarter
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$ | 31.67 | $ | 20.43 |
High
|
Low
|
|||||||
Fiscal Year Ended December 31, 2010
|
||||||||
Fourth Quarter
|
$ | 33.39 | $ | 24.99 | ||||
Third Quarter
|
$ | 37.29 | $ | 28.53 | ||||
Second Quarter
|
$ | 40.48 | $ | 30.66 | ||||
First Quarter
|
$ | 36.83 | $ | 25.05 |
12/06
|
12/07
|
12/08
|
12/09
|
12/10
|
12/11
|
||
Acorda Therapeutics, Inc
|
100.00
|
138.64
|
129.48
|
159.09
|
172.10
|
150.51
|
|
NASDAQ Composite
|
100.00
|
110.26
|
65.65
|
95.19
|
112.10
|
110.81
|
|
NASDAQ Biotechnology
|
100.00
|
102.53
|
96.57
|
110.05
|
117.19
|
124.54
|
Year Ended December 31,
|
||||||||||||||||||||
2011
|
2010
|
2009
|
2008
|
2007
|
||||||||||||||||
(in thousands, except per share data)
|
||||||||||||||||||||
Statement of Operations Data:
|
||||||||||||||||||||
Revenues:
|
||||||||||||||||||||
Net revenue
|
$ | 256,271 | $ | 181,545 | $ | 49,959 | $ | 47,728 | $ | 39,426 | ||||||||||
Milestone revenue
|
25,000 | — | 4,714 | — | — | |||||||||||||||
License revenue
|
9,057 | 9,428 | — | — | — | |||||||||||||||
Royalty revenue
|
1,909 | 32 | — | — | — | |||||||||||||||
Grant revenue
|
— | — | — | 99 | 60 | |||||||||||||||
Total net revenue
|
292,237 | 191,005 | 54,673 | 47,827 | 39,486 | |||||||||||||||
Costs and expenses:
|
||||||||||||||||||||
Cost of sales
|
64,183 | 35,518 | 11,059 | 11,355 | 8,356 | |||||||||||||||
Cost of milestone and license revenue
|
2,384 | 660 | 330 | — | — | |||||||||||||||
Research and development
|
42,108 | 30,600 | 34,611 | 36,604 | 22,410 | |||||||||||||||
Selling, general and administrative
|
148,508 | 132,657 | 89,930 | 73,307 | 48,168 | |||||||||||||||
Total operating expenses
|
257,183 | 199,435 | 135,930 | 121,266 | 78,934 | |||||||||||||||
Operating income (loss)
|
35,054 | (8,430 | ) | (81,257 | ) | (73,439 | ) | (39,448 | ) | |||||||||||
Other income (expense):
|
||||||||||||||||||||
Interest and amortization of debt discount expense
|
(3,570 | ) | (3,922 | ) | (4,415 | ) | (5,591 | ) | (2,664 | ) | ||||||||||
Interest income
|
552 | 575 | 1,750 | 4,682 | 4,087 | |||||||||||||||
Other income (expense)
|
(18 | ) | 8 | (18 | ) | 8 | 51 | |||||||||||||
Total other income (expense)
|
(3,036 | ) | (3,339 | ) | (2,683 | ) | (901 | ) | 1,474 | |||||||||||
Income (loss) before income taxes
|
$ | 32,018 | $ | (11,769 | ) | $ | (83,940 | ) | $ | (74,340 | ) | $ | (37,974 | ) | ||||||
Provision for income taxes
|
(1,413 | ) | — | — | — | — | ||||||||||||||
Net income (loss)
|
$ | 30,605 | $ | (11,769 | ) | $ | (83,940 | ) | $ | (74,340 | ) | $ | (37,974 | ) | ||||||
Net income (loss) per share —basic
|
$ | 0.78 | $ | (0.31 | ) | $ | (2.22 | ) | $ | (2.19 | ) | $ | (1.45 | ) | ||||||
Net income (loss) per share —diluted
|
$ | 0.76 | $ | (0.31 | ) | $ | (2.22 | ) | $ | (2.19 | ) | $ | (1.45 | ) | ||||||
Weighted average shares of common stock outstanding used in computing net income (loss) per share —basic
|
39,000 | 38,355 | 37,735 | 33,939 | 26,237 | |||||||||||||||
Weighted average shares of common stock outstanding used in computing net income (loss) per share —diluted
|
40,064 | 38,355 | 37,735 | 33,939 | 26,237 |
As of December 31,
|
||||||||||||||||||||
2011
|
2010
|
2009
|
2008
|
2007
|
||||||||||||||||
(in thousands)
|
||||||||||||||||||||
Consolidated Balance Sheet Data:
|
||||||||||||||||||||
Cash and cash equivalents
|
$ | 57,954 | $ | 34,641 | $ | 47,314 | $ | 29,613 | $ | 16,810 | ||||||||||
Short term investments
|
237,953 | 205,389 | 224,778 | 216,435 | 78,310 | |||||||||||||||
Working capital
|
273,599 | 217,274 | 220,380 | 207,445 | 71,770 | |||||||||||||||
Total assets
|
379,488 | 342,101 | 319,471 | 281,501 | 127,306 | |||||||||||||||
Deferred product revenue—Zanaflex tablets
|
9,967 | 9,526 | 9,215 | 7,867 | 7,914 | |||||||||||||||
Deferred product revenue—Zanaflex Capsules
|
20,632 | 21,770 | 21,489 | 16,436 | 13,924 | |||||||||||||||
Current portion of deferred license revenue
|
9,057 | 9,429 | 9,429 | — | — | |||||||||||||||
Non-current portion of deferred license revenue
|
77,742 | 86,429 | 95,857 | — | — | |||||||||||||||
Current portion of revenue interest liability—PRF transaction
|
1,001 | 1,297 | 6,179 | 6,181 | 1,785 | |||||||||||||||
Put/call option liability—PRF transaction
|
1,030 | 391 | 638 | 338 | 463 | |||||||||||||||
Non-current portion of revenue interest liability—PRF transaction
|
1,898 | 3,586 | 5,631 | 12,498 | 17,444 | |||||||||||||||
Long term convertible notes payable
|
5,230 | 6,186 | 7,112 | 6,905 | 6,703 | |||||||||||||||
Total stockholders’ equity
|
205,209 | 151,261 | 137,333 | 207,157 | 63,433 |
·
|
We expect 2012 net revenue from the sale of Ampyra to range from $255 million to $275 million.
|
·
|
We expect combined net revenues from sales of Zanaflex Capsules (including from sales of authorized generic tizanidine hydrochloride under our agreement with Watson Pharma) and Zanaflex tablets, and royalty revenue from sales by Biogen Idec of Fampyra outside the U.S., of at least $25 million.
|
·
|
Research and development expenses are expected to range from $50 million to $60 million, excluding share-based compensation charges. These expenses will include post-marketing studies for Ampyra, Phase 2 proof-of-concept studies in cerebral palsy and chronic stroke, and sponsorship of investigator-initiated studies of Ampyra.
|
·
|
Selling, general and administrative expenses are expected to range from $145 million to $160 million, excluding share-based compensation charges. The principal factors affecting SG&A will be commercial and administrative costs related to Ampyra.
|
·
|
We expect to be cash flow positive in 2012.
|
·
|
Our Phase 2 proof-of-concept clinical trial of dalfampridine in adults with cerebral palsy, which was commenced in December 2011, is expected to continue throughout 2012.
|
·
|
We plan to submit an IND for rHIgM22 with the FDA in the first half of 2012, and to begin a Phase 1 clinical trial by the end of 2012.
|
·
|
Initial study results from our ongoing GGF2 Phase 1 clinical trial are expected to be announced in the second half of 2012.
|
·
|
A Phase 2 proof-of-concept clinical trial of dalfampridine in chronic stroke patients is expected to begin in the second half of 2012.
|
·
|
A Phase 2 clinical trial of AC105 in patients with acute SCI is expected to begin in the second half of 2012.
|
·
|
Funding of investigator-initiated studies of Ampyra in MS, focused on a range of neurological functions and other neurological disorders, will be ongoing in 2012.
|
|
•
|
with respect to Zanaflex net revenues up to and including $30.0 million for each fiscal year during the term of the agreement, 15% of such net revenues;
|
|
•
|
with respect to Zanaflex net revenues in excess of $30.0 million but less than and including $60.0 million for each fiscal year during the term of the agreement, 6% of such net revenues; and
|
|
•
|
with respect to Zanaflex net revenues in excess of $60.0 million for each fiscal year during the term of the agreement, 1% of such net revenues.
|
Payments due by period (1)
|
||||||||||||||||
(In thousands)
|
Total
|
Less than
1 year
|
1-3 years
|
4-5 years
|
||||||||||||
Convertible note payable (2)
|
$ | 5,721 | $ | 1,144 | $ | 3,433 | $ | 1,144 | ||||||||
Operating leases (3)
|
20,371 | 2,275 | 10,589 | 7,507 | ||||||||||||
Inventory purchase commitments (4)
|
12,442 | 12,442 | — | — | ||||||||||||
Total
|
$ | 38,534 | $ | 15,861 | $ | 14,022 | $ | 8,651 |
(1)
|
Excludes PRF principal and interest payments, due to uncertainty as to the amount and timing of such payments.
|
(2)
|
Represents the remaining 6 annual payments of principal and interest to be made on the convertible note payable to Saints Capital.
|
(3)
|
Represents payments for Hawthorne, NY lease through June 2012, then for Ardsley, NY lease thereafter.
|
(4)
|
Represents Zanaflex and Ampyra inventory commitments. The Ampyra inventory commitment is an estimate as the price paid for Ampyra inventory is based on a percentage of the net product sales during the quarter Alkermes ships inventory to us. Under our supply agreement with Alkermes, we provide Alkermes with monthly written 18-month forecasts, and with annual written five-year forecasts for our supply requirements of Ampyra and two-year forecasts for our supply requirements of Zanaflex Capsules. In each of the five months for Zanaflex and three months for Ampyra following the submission of our written 18-month forecast we are obligated to purchase the quantity specified in the forecast, even if our actual requirements are greater or less. We have agreed to purchase at least 75% of our annual requirements of Ampyra from Alkermes, unless Alkermes is unable or unwilling to meet its requirements, for a percentage of net product sales and the quantity of product shipped by Alkermes to us.
|
(in thousands)
|
Government chargebacks and rebates
|
Managed care contract rebates
|
Copay mitigation rebates
|
Cash discounts
|
Product returns
|
Data fees and fees for services payable to wholesalers
|
Total
|
|||||||||||||||||||||
Balance at December 31, 2008
|
572 | - | - | 258 | - | 620 | 1,450 | |||||||||||||||||||||
Allowances for sales 2009
|
3,383 | - | - | 1,576 | - | 2,889 | 7,848 | |||||||||||||||||||||
Allowances for prior year sales
|
468 | - | - | - | - | (7 | ) | 461 | ||||||||||||||||||||
Actual credits for sales during 2009
|
(2,228 | ) | - | - | (1,434 | ) | - | (2,154 | ) | (5,816 | ) | |||||||||||||||||
Actual credits for prior year sales
|
(430 | ) | - | - | (168 | ) | - | (586 | ) | (1,184 | ) | |||||||||||||||||
Balance at December 31, 2009
|
1,765 | - | - | 232 | - | 762 | 2,759 | |||||||||||||||||||||
Allowances for sales 2010
|
5,291 | 333 | 2,961 | 2,579 | 353 | 3,726 | 15,243 | |||||||||||||||||||||
Allowances for prior year sales
|
(361 | ) | - | - | - | - | 26 | (335 | ) | |||||||||||||||||||
Actual credits for sales during 2010
|
(3,384 | ) | (111 | ) | (2,930 | ) | (2,428 | ) | - | (2,482 | ) | (11,335 | ) | |||||||||||||||
Actual credits for prior year sales
|
(521 | ) | - | - | (59 | ) | - | (789 | ) | (1,369 | ) | |||||||||||||||||
Balance at December 31, 2010
|
2,790 | 222 | 31 | 324 | 353 | 1,243 | 4,963 | |||||||||||||||||||||
Allowances for sales 2011
|
10,139 | 1,534 | 4,888 | 3,406 | 127 | 4,976 | 25,070 | |||||||||||||||||||||
Allowances for prior year sales
|
(157 | ) | (70 | ) | (2 | ) | (43 | ) | - | (321 | ) | (593 | ) | |||||||||||||||
Actual credits for sales during 2011
|
(7,242 | ) | (1,260 | ) | (4,753 | ) | (3,188 | ) | - | (3,978 | ) | (20,421 | ) | |||||||||||||||
Actual credits for prior year sales
|
(2,431 | ) | (153 | ) | (29 | ) | (196 | ) | - | (922 | ) | (3,731 | ) | |||||||||||||||
Balance at December 31, 2011
|
$ | 3,099 | $ | 273 | $ | 135 | $ | 303 | $ | 480 | $ | 998 | $ | 5,288 |
Assumption
|
Method of estimating
|
||||||
●
|
Estimated expected term of options
|
●
|
Historical term of our options
|
||||
●
|
Expected volatility
|
●
|
Combination of historic volatility of our common stock since October 1, 2006 and the historic volatility of the stock of our peer companies
|
||||
●
|
Risk-free interest rate
|
●
|
Yields of U.S. Treasury securities corresponding with the expected life of option grants
|
||||
●
|
Forfeiture rates
|
●
|
Historical forfeiture data
|
|
(1)
|
The following financial statements of the Company and the Report of Independent Registered Public Accounting Firm are included in this Annual Report on Form 10-K:
|
PAGE
|
|
Consolidated Financial Statements of Acorda Therapeutics, Inc. and Subsidiaries:
|
|
Reports of Independent Registered Public Accounting Firms
|
F-2
|
Consolidated Balance Sheets
|
F-4
|
Consolidated Statements of Operations
|
F-5
|
Consolidated Statements of Changes in Stockholders’ Equity
|
F-6
|
Consolidated Statements of Cash Flows
|
F-7
|
Notes to Consolidated Financial Statements
|
F-8
|
December 31,
|
|||
2011
|
2010
|
||
Assets
|
|||
Current assets:
|
|||
Cash and cash equivalents
|
$57,954
|
$34,641
|
|
Restricted cash
|
303
|
302
|
|
Short-term investments
|
237,953
|
205,389
|
|
Trade accounts receivable, net of allowances of $879 and $289, as of December 31, 2011 and 2010, respectively
|
22,828
|
22,272
|
|
Prepaid expenses
|
6,534
|
6,413
|
|
Finished goods inventory held by the Company
|
27,256
|
36,232
|
|
Finished goods inventory held by others
|
1,126
|
2,186
|
|
Other current assets
|
6,988
|
3,734
|
|
Total current assets
|
360,942
|
311,169
|
|
Property and equipment, net of accumulated depreciation
|
3,858
|
3,203
|
|
Intangible assets, net of accumulated amortization
|
8,769
|
21,336
|
|
Non-current portion of deferred cost of license revenue
|
5,442
|
6,050
|
|
Other assets
|
477
|
343
|
|
Total assets
|
$379,488
|
$342,101
|
|
Liabilities and Stockholders’ Equity
|
|||
Current liabilities:
|
|||
Accounts payable
|
$21,393
|
$16,961
|
|
Accrued expenses and other current liabilities
|
24,149
|
33,769
|
|
Deferred product revenue—Zanaflex tablets
|
9,967
|
9,526
|
|
Deferred product revenue—Zanaflex Capsules
|
20,632
|
21,770
|
|
Current portion of deferred license revenue
|
9,057
|
9,429
|
|
Current portion of revenue interest liability
|
1,001
|
1,297
|
|
Current portion of convertible notes payable
|
1,144
|
1,144
|
|
Total current liabilities
|
87,343
|
93,896
|
|
Non-current portion of deferred license revenue
|
77,742
|
86,429
|
|
Put/call liability
|
1,030
|
391
|
|
Non-current portion of revenue interest liability
|
1,898
|
3,586
|
|
Non-current portion of long-term convertible notes payable
|
5,230
|
6,185
|
|
Other non-current liabilities
|
1,036
|
353
|
|
Commitments and contingencies
|
|||
Stockholders’ equity:
|
|||
Common stock, $0.001 par value. Authorized 80,000,000 shares at December 31, 2011 and 2010; issued and outstanding 39,328,495 and 38,779,370 shares, including those held in treasury, as of December 31, 2011 and 2010, respectively
|
39
|
39
|
|
Treasury stock
at cost (12,420 shares)
|
(329)
|
(329)
|
|
Additional paid-in capital
|
614,914
|
591,649
|
|
Accumulated deficit
|
(409,481)
|
(440,086)
|
|
Accumulated other comprehensive income (loss)
|
66
|
(12)
|
|
Total stockholders’ equity
|
205,209
|
151,261
|
|
Total liabilities and stockholders’ equity
|
$379,488
|
$342,101
|
Year ended December 31,
|
Year ended December 31,
|
Year ended December 31,
|
||||||||||
2011
|
2010
|
2009
|
||||||||||
Revenues:
|
||||||||||||
Net revenue
|
$ | 256,271 | $ | 181,545 | $ | 49,959 | ||||||
Milestone revenue
|
25,000 | — | — | |||||||||
License revenue
|
9,057 | 9,428 | 4,714 | |||||||||
Royalty revenue
|
1,909 | 32 | — | |||||||||
Total net revenues
|
292,237 | 191,005 | 54,673 | |||||||||
Costs and expenses:
|
||||||||||||
Cost of sales
|
64,183 | 35,518 | 11,059 | |||||||||
Cost of milestone and license revenue
|
2,384 | 660 | 330 | |||||||||
Research and development
|
42,108 | 30,600 | 34,611 | |||||||||
Selling, general and administrative
|
148,508 | 132,657 | 89,930 | |||||||||
Total operating expenses
|
257,183 | 199,435 | 135,930 | |||||||||
Operating income (loss)
|
35,054 | (8,430 | ) | (81,257 | ) | |||||||
Other expense:
|
||||||||||||
Interest and amortization of debt discount expense
|
(3,570 | ) | (3,922 | ) | (4,415 | ) | ||||||
Interest income
|
552 | 575 | 1,750 | |||||||||
Other income (expense)
|
(18 | ) | 8 | (18 | ) | |||||||
Total other expense
|
(3,036 | ) | (3,339 | ) | (2,683 | ) | ||||||
Income (loss) before taxes
|
$ | 32,018 | $ | (11,769 | ) | $ | (83,940 | ) | ||||
Provision for income taxes
|
(1,413 | ) | — | — | ||||||||
Net income (loss)
|
$ | 30,605 | $ | (11,769 | ) | $ | (83,940 | ) | ||||
Net income (loss) per share—basic
|
$ | 0.78 | $ | (0.31 | ) | $ | (2.22 | ) | ||||
Net income (loss) per share—diluted
|
$ | 0.76 | $ | (0.31 | ) | $ | (2.22 | ) | ||||
Weighted average common shares outstanding used in computing net income (loss) per share—basic
|
39,000 | 38,355 | 37,735 | |||||||||
Weighted average common shares outstanding used in computing net income (loss) per share—diluted
|
40,064 | 38,355 | 37,735 |
Common stock
|
|||||||||||||
Number
of
shares
|
Par
value
|
Treasury stock
|
Additional
paid-in
capital
|
Accumulated
deficit
|
Accumulated
other
comprehensive
income
|
Total
stockholders’
equity
|
|||||||
Balance at December 31, 2008
|
37,613
|
$38
|
$0
|
$550,683
|
$(344,377)
|
$813
|
$207,157
|
||||||
Compensation expense for issuance of stock options to employees
|
—
|
—
|
—
|
9,690
|
—
|
—
|
9,690
|
||||||
Compensation expense for issuance of restricted stock to employees
|
128
|
—
|
—
|
2,588
|
—
|
—
|
2,588
|
||||||
Exercise of stock options
|
194
|
—
|
—
|
2,542
|
—
|
—
|
2,542
|
||||||
Comprehensive loss
|
—
|
||||||||||||
Unrealized loss on investment securities
|
—
|
—
|
—
|
—
|
—
|
(704)
|
(704)
|
||||||
Net loss
|
—
|
—
|
—
|
—
|
(83,940)
|
—
|
(83,940)
|
||||||
Total comprehensive loss
|
(84,644)
|
||||||||||||
Balance at December 31, 2009
|
37,935
|
$38
|
$0
|
$565,503
|
$(428,317)
|
$109
|
$137,333
|
||||||
Compensation expense for issuance of stock options to employees
|
—
|
—
|
—
|
12,464
|
—
|
—
|
12,464
|
||||||
Compensation expense for issuance of restricted stock to employees
|
196
|
—
|
(329)
|
5,313
|
—
|
—
|
4,984
|
||||||
Exercise of stock options
|
648
|
1
|
—
|
8,369
|
—
|
—
|
8,370
|
||||||
Comprehensive loss
|
|||||||||||||
Unrealized loss on investment securities
|
—
|
—
|
—
|
—
|
—
|
(121)
|
(121)
|
||||||
Net loss
|
—
|
—
|
—
|
—
|
(11,769)
|
—
|
(11,769)
|
||||||
Total comprehensive loss
|
(11,890)
|
||||||||||||
Balance at December 31, 2010
|
38,779
|
$39
|
$(329)
|
$591,649
|
$(440,086)
|
$(12)
|
$151,261
|
||||||
Compensation expense for issuance of stock options to employees
|
—
|
—
|
—
|
13,675
|
—
|
—
|
13,675
|
||||||
Compensation expense for issuance of restricted stock to employees
|
220
|
—
|
—
|
5,628
|
—
|
—
|
5,628
|
||||||
Exercise of stock options
|
329
|
—
|
—
|
3,962
|
—
|
—
|
3,962
|
||||||
Comprehensive income
|
|||||||||||||
Unrealized gain on investment securities
|
—
|
—
|
—
|
—
|
—
|
78
|
78
|
||||||
Net income
|
—
|
—
|
—
|
—
|
30,605
|
—
|
30,605
|
||||||
Total comprehensive income
|
30,683
|
||||||||||||
Balance at December 31, 2011
|
39,328
|
$39
|
$(329)
|
$614,914
|
$(409,481)
|
$66
|
$205,209
|
Year ended
December 31,
|
Year ended
December 31,
|
Year ended
December 31
|
|||
2011
|
2010
|
2009
|
|||
Cash flows from operating activities:
|
|||||
Net income (loss)
|
$30,605
|
$(11,769)
|
$(83,940)
|
||
Adjustments to reconcile net loss to net cash provided by/(used in) operating activities:
|
|||||
Share-based compensation expense
|
19,303
|
17,777
|
12,278
|
||
Amortization of net premiums and discounts on short-term investments
|
6,750
|
4,473
|
4,931
|
||
Amortization of revenue interest issuance cost
|
104
|
96
|
93
|
||
Depreciation and amortization expense
|
4,625
|
3,951
|
2,762
|
||
Intangible asset impairment
|
13,038
|
—
|
—
|
||
(Gain) loss on put/call liability
|
639
|
(246)
|
300
|
||
Gain on disposal of property and equipment
|
—
|
—
|
(15)
|
||
Changes in assets and liabilities:
|
|||||
Increase in accounts receivable
|
(556)
|
(16,533)
|
(1,116)
|
||
Increase in prepaid expenses and other current assets
|
(3,375)
|
(1,892)
|
(3,320)
|
||
Decrease (increase) in inventory held by the Company
|
8,976
|
(31,735)
|
(619)
|
||
Decrease in inventory held by others
|
1,060
|
209
|
78
|
||
Decrease (increase) in non-current portion of deferred cost of license revenue
|
608
|
660
|
(6,710)
|
||
(Decrease) increase in other assets
|
(237)
|
1
|
6
|
||
(Decrease) increase in accounts payable, accrued expenses, other current liabilities
|
(6,108)
|
24,706
|
2,024
|
||
(Decrease) increase in revenue interest liability interest payable
|
(23)
|
(76)
|
200
|
||
(Decrease) increase in current portion of deferred license revenue
|
(371)
|
—
|
9,428
|
||
(Decrease) increase in non-current portion of deferred license revenue
|
(8,686)
|
(9,428)
|
95,857
|
||
Increase in other non-current liabilities
|
682
|
—
|
—
|
||
Increase in deferred product revenue—Zanaflex tablets
|
441
|
311
|
1,348
|
||
(Decrease) increase in deferred product revenue—Zanaflex Capsules
|
(1,138)
|
281
|
5,053
|
||
Restricted cash
|
(1)
|
(1)
|
(4)
|
||
Net cash (used in)/provided by operating activities
|
66,336
|
(19,215)
|
38,634
|
||
Cash flows from investing activities:
|
|||||
Purchases of property and equipment
|
(2,192)
|
(2,446)
|
(1,148)
|
||
Purchases of intangible assets
|
(3,595)
|
(6,998)
|
(1,279)
|
||
Purchases of short-term investments
|
(266,736)
|
(310,955)
|
(310,378)
|
||
Proceeds from maturities of short-term investments
|
227,500
|
325,750
|
296,400
|
||
Net cash (used in)/provided by investing activities
|
(45,023)
|
5,351
|
(16,405)
|
||
Cash flows from financing activities:
|
|||||
Proceeds from issuance of common stock and option and warrant exercises
|
3,962
|
8,370
|
2,542
|
||
Purchase of treasury stock
|
—
|
(329)
|
—
|
||
Repayments of revenue interest liability
|
(1,962)
|
(6,850)
|
(7,070)
|
||
Net cash provided by/(used in) financing activities
|
2,000
|
1,191
|
(4,528)
|
||
Net increase (decrease) in cash and cash equivalents
|
23,313
|
(12,673)
|
17,701
|
||
Cash and cash equivalents at beginning of period
|
34,641
|
47,314
|
29,613
|
||
Cash and cash equivalents at end of period
|
$57,954
|
$34,641
|
$47,314
|
||
Supplemental disclosure:
|
|||||
Cash paid for interest
|
$3,404
|
$3,781
|
$4,040
|
||
Cash paid for taxes
|
1,176
|
—
|
—
|
|
(a)
|
Cash equivalents, grants receivables, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to the short-term nature of these instruments;
|
|
(b)
|
Available-for-sale securities are recorded based primarily on quoted market prices;
|
|
(c)
|
Put/call liability’s fair value is based on revenue projections and business, general economic and market conditions that could be reasonably evaluated as of the valuation date;
|
(In thousands)
|
Amortized
Cost
|
Gross
unrealized
gains
|
Gross
unrealized
losses
|
Estimated
fair
value
|
|||
December 31, 2011
|
|||||||
US Treasury bonds
|
$237,887
|
$72
|
$(6)
|
$237,953
|
|||
December 31, 2010
|
|||||||
US Treasury bonds
|
$205,401
|
$6
|
$(18)
|
$205,389
|
(In thousands)
|
December 31,
2011
|
December 31,
2010
|
Estimated
useful lives used
|
||
Leasehold improvements
|
$3,240
|
$3,178
|
Remaining lease term
|
||
Computer equipment
|
5,859
|
4,699
|
3 years
|
||
Laboratory equipment
|
2,534
|
2,223
|
5 years
|
||
Furniture and fixtures
|
760
|
760
|
5 years
|
||
Capital in Progress
|
1,093
|
449
|
3 years
|
||
13,486
|
11,309
|
||||
Less accumulated depreciation
|
(9,628)
|
(8,106)
|
|||
$3,858
|
$3,203
|
(In thousands)
|
December 31,
2011
|
December 31,
2010
|
|
Bonus payable
|
$4,725
|
$4,291
|
|
Ampyra and Zanaflex discount and allowances accruals
|
4,680
|
4,426
|
|
Ampyra milestone
|
2,500
|
—
|
|
Accrued inventory
|
2,464
|
9,665
|
|
Royalties payable
|
1,977
|
2,066
|
|
Sales force commissions and incentive payments payable
|
1,893
|
6,717
|
|
Commercial and marketing expense accruals
|
1,811
|
721
|
|
Vacation accrual
|
1,171
|
1,220
|
|
Legal accruals
|
898
|
1,024
|
|
Research and development expense accruals
|
640
|
1,880
|
|
Other accrued expenses
|
1,390
|
1,759
|
|
$24,149
|
$33,769
|
Year ended December 31,
|
|||||
2011
|
2010
|
2009
|
|||
Employees and directors:
|
|||||
Estimated volatility
|
62.80%
|
66.31%
|
75.96%
|
||
Expected life in years
|
5.47
|
5.50
|
5.56
|
||
Risk free interest rate
|
2.23%
|
2.57%
|
2.15%
|
||
Dividend yield
|
—
|
—
|
—
|
Year ended December 31,
|
||||||||||||
(In thousands)
|
2011
|
2010
|
2009
|
|||||||||
Research and development
|
$ | 5,801 | $ | 5,247 | $ | 3,662 | ||||||
Selling, general and administrative
|
13,502 | 12,530 | 8,616 | |||||||||
Total
|
$ | 19,303 | $ | 17,777 | $ | 12,278 |
Number
of Shares (In thousands)
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining
Contractual Term
|
Intrinsic
Value (In thousands)
|
||||
Balance at December 31, 2008
|
3,284
|
$13.55
|
|||||
Granted
|
826
|
21.97
|
|||||
Forfeited and expired
|
(205)
|
16.94
|
|||||
Exercised
|
(193)
|
13.15
|
|||||
Balance at December 31, 2009
|
3,712
|
15.25
|
|||||
Granted
|
1,136
|
32.49
|
|||||
Forfeited and expired
|
(116)
|
25.09
|
|||||
Exercised
|
(648)
|
13.00
|
|||||
Balance at December 31, 2010
|
4,084
|
20.13
|
|||||
Granted
|
1,239
|
23.52
|
|||||
Forfeited and expired
|
(201)
|
25.97
|
|||||
Exercised
|
(329)
|
12.06
|
|||||
Balance at December 31, 2011
|
4,793
|
$21.31
|
6.7
|
$23,129
|
|||
Vested and expected to vest at December 31, 2011
|
4,713
|
$21.25
|
6.7
|
$23,032
|
|||
Vested and exercisable at December 31, 2011
|
2,987
|
$18.45
|
5.6
|
$21,043
|
Options Outstanding
|
Options Exercisable
|
||||||||
Range of exercise price
|
Outstanding
as of
December 31,
2011 (In thousands)
|
Weighted-
average
remaining
contractual life
|
Weighted-
average
exercise price
|
Exercisable
as of
December 31,
2011 (In thousands)
|
Weighted-
average
exercise price
|
||||
$2.45-$16.88
|
1,064
|
3.42
|
$ 7.45
|
1,064
|
$ 7.45
|
||||
$17.52-$21.52
|
1,008
|
6.49
|
20.17
|
737
|
19.97
|
||||
$21.61-$22.13
|
1,062
|
8.11
|
22.07
|
418
|
22.09
|
||||
$22.24-$31.67
|
966
|
8.01
|
28.00
|
483
|
28.07
|
||||
$31.71-$37.48
|
693
|
8.23
|
33.80
|
285
|
33.89
|
||||
4,793
|
6.73
|
$21.31
|
2,987
|
$18.45
|
Restricted Stock
|
Number of Shares (In thousands)
|
|
Nonvested at December 31, 2008
|
150
|
|
Granted
|
208
|
|
Vested
|
(128)
|
|
Forfeited
|
(26)
|
|
Nonvested at December 31, 2009
|
204
|
|
Granted
|
334
|
|
Vested
|
(196)
|
|
Forfeited
|
(18)
|
|
Nonvested at December 31, 2010
|
324
|
|
Granted
|
302
|
|
Vested
|
(221)
|
|
Forfeited
|
(28)
|
|
Nonvested at December 31, 2011
|
377
|
(In thousands, except per share data)
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
Year ended
December 31,
2009
|
||
Basic and diluted
|
|||||
Net income (loss)
|
$30,605
|
$(11,769)
|
$(83,940)
|
||
Weighted average common shares outstanding used in computing net income (loss) per share—basic
|
39,000
|
38,355
|
37,735
|
||
Plus: net effect of dilutive stock options and restricted common shares
|
1,064
|
—
|
—
|
||
Weighted average common shares outstanding used in computing net income (loss) per share—diluted
|
40,064
|
38,355
|
37,735
|
||
Net income (loss) per share—basic
|
$0.78
|
$(0.31)
|
$(2.22)
|
||
Net income (loss) per share—diluted
|
$0.76
|
$(0.31)
|
$(2.22)
|
(In thousands)
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
Year ended
December 31,
2009
|
||
Denominator
|
|||||
Dilutive stock options and restricted common shares
|
4,106
|
4,408
|
3,916
|
||
Convertible note
|
67
|
67
|
67
|
(In thousands)
|
December 31,
2011
|
December 31,
2010
|
December 31,
2009
|
||
Statutory rate applied to pre-tax income (loss)
|
$11,206
|
$(4,017)
|
$(28,448)
|
||
Add (deduct):
|
|||||
Meals and entertainment
|
274
|
254
|
232
|
||
Stock options and restricted stock
|
278
|
(154)
|
2,064
|
||
State tax
|
325
|
(387)
|
(1,361)
|
||
Other
|
214
|
(163)
|
(233)
|
||
Increase (decrease) to valuation allowance (net)
|
(6,479)
|
6,627
|
27,746
|
||
Increase in statutory tax rate
|
(4,118)
|
—
|
—
|
||
Research and development credit
|
(287)
|
(2,160)
|
—
|
||
Income taxes
|
$1,413
|
$—
|
$—
|
(In thousands)
|
December 31,
2011
|
December 31,
2010
|
|
Net operating loss carry-forwards
|
$74,774
|
$82,914
|
|
State NOL net of federal benefit
|
942
|
1,601
|
|
Research and development tax credit
|
4,025
|
3,738
|
|
Property and equipment
|
(532)
|
146
|
|
Intellectual property
|
7,399
|
2,608
|
|
Stock options and restricted stock
|
13,910
|
13,134
|
|
Deferred revenue
|
38,958
|
40,248
|
|
Revenue interest liability
|
1,504
|
1,939
|
|
Medtronic acquisition
|
1,110
|
—
|
|
NRI acquisition
|
760
|
795
|
|
Other temporary differences
|
4,746
|
6,703
|
|
147,596
|
153,826
|
||
Less valuation allowance
|
(147,596)
|
(153,826)
|
|
Net deferred tax assets
|
$—
|
$—
|
(In thousands)
|
|
2012
|
$2,275
|
2013
|
3,443
|
2014
|
3,529
|
2015
|
3,617
|
2016
|
3,707
|
Later years
|
25,994
|
$42,565
|
(In thousands)
|
December 31,
2011
|
December 31,
2010
|
Estimated
remaining
useful lives as of
December 31,
2011
|
||
Zanaflex Capsule patents
|
$19,350
|
$19,350
|
0 years
|
||
Zanaflex trade name
|
2,150
|
2,150
|
0 years
|
||
Ampyra milestones
|
5,750
|
3,250
|
15 years
|
||
CSRO royalty buyout
|
3,000
|
3,000
|
8 years
|
||
Website development costs
|
4,028
|
2,975
|
0-3 years
|
||
Website development costs – in process
|
42
|
—
|
3 years
|
||
34,320
|
30,725
|
||||
Less accumulated amortization
|
25,551
|
9,389
|
|||
$8,769
|
$21,336
|
(In thousands)
|
|
2012
|
$1,579
|
2013
|
1,136
|
2014
|
870
|
2015
|
588
|
2016
|
588
|
$4,761
|
|
•
|
with respect to Zanaflex net revenues up to and including $30.0 million for each fiscal year during the term of the agreement, 15% of such net revenues;
|
|
•
|
with respect to Zanaflex net revenues in excess of $30.0 million but less than and including $60.0 million for each fiscal year during the term of the agreement, 6% of such net revenues; and
|
|
•
|
with respect to Zanaflex net revenues in excess of $60.0 million for each fiscal year during the term of the agreement, 1% of such net revenues.
|
|
•
|
Level 1 Quoted prices in active markets for identical assets or liabilities.
|
|
•
|
Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices 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 assets or liabilities.
|
|
•
|
Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
(In thousands)
|
Level 1
|
Level 2
|
Level 3
|
|||
2011
|
||||||
Assets Carried at Fair Value:
|
||||||
Cash equivalents
|
$38,340
|
$—
|
$—
|
|||
Short-term investments
|
237,953
|
—
|
—
|
|||
Liabilities Carried at Fair Value:
|
||||||
Put/call liability
|
—
|
—
|
1,030
|
|||
2010
|
||||||
Assets Carried at Fair Value:
|
||||||
Cash equivalents
|
$23,529
|
$—
|
$—
|
|||
Short-term investments
|
205,389
|
—
|
—
|
|||
Liabilities Carried at Fair Value:
|
||||||
Put/call liability
|
—
|
—
|
391
|
(In thousands)
|
Balance as of
December 31,
2010
|
Realized loss
included
in net income
|
Unrealized
gains included
in other
comprehensive
income/loss
|
Balance as of
December 31,
2011
|
|||
Liabilities Carried at Fair Value:
|
|||||||
Put/call liability
|
$391
|
$639
|
$—
|
$1,030
|
(in thousands)
|
Net Carrying Value as of
|
Fair Value Measured and Recorded Using
|
Impairment Losses
|
||||||
December 31,
|
December 31,
|
||||||||
2011
|
Level 1
|
Level 2
|
Level 3
|
2011
|
|||||
Zanaflex intangible asset (1)
|
$—
|
$—
|
$—
|
$—
|
$13,038
|
||||
Total impairment losses
|
$13,038
|
(1)
|
$962,000 in intangible amortization recorded during the nine-month period ended September 30, 2011.
|
(In thousands, except per share amounts)
|
2011
|
||||||
March 31
|
June 30
|
September 30
|
December 31
|
||||
Total net revenues
|
$61,286
|
$65,276
|
$93,031
|
$72,644
|
|||
Gross profit
|
49,236
|
53,228
|
66,380
|
59,210
|
|||
Net income (loss)—basic and diluted
|
(672)
|
(285)
|
18,867
|
12,694
|
|||
Net income (loss) per share—basic
|
$(0.02)
|
$(0.01)
|
$0. 48
|
$0.32
|
|||
Net income (loss) per share—diluted
|
(0.02)
|
(0.01)
|
0.47
|
0.32
|
2010
|
|||||||
March 31
|
June 30
|
September 30
|
December 31
|
||||
Total net revenues
|
$17,747
|
$42,836
|
$63,622
|
$66,800
|
|||
Gross profit
|
14,671
|
35,004
|
51,956
|
53,856
|
|||
Net income (loss)—basic and diluted
|
(21,115)
|
(6,763)
|
12,437
|
3,671
|
|||
Net income (loss) per share—basic
|
$(0.56)
|
$(0.18)
|
$0.32
|
$0.10
|
|||
Net income (loss) per share—diluted
|
(0.56)
|
(0.18)
|
0.31
|
0.09
|
Exhibit No.
|
Description
|
|
3.1
|
Amended and Restated Certificate of Incorporation of the Registrant. Incorporated herein by reference to Exhibit 3.1 to the Registrant’s Registration Statement on Form S-1, No. 333-138842, filed on November 20, 2006.
|
|
3.2
|
Bylaws of the Registrant, as amended on December 15, 2011.
|
|
4.1
|
Specimen Stock Certificate evidencing shares of common stock. Incorporated herein by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.1**
|
Acorda Therapeutics 1999 Employee Stock Option Plan. Incorporated herein by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.2**
|
Amendment to 1999 Employee Stock Option Plan. Incorporated herein by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.3**
|
Amendment No. 2 to 1999 Employee Stock Option Plan. Incorporated herein by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.4**
|
Acorda Therapeutics 2006 Employee Incentive Plan. Incorporated herein by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
|
10.5**
|
Acorda Therapeutics 2006 Employee Incentive Plan, as amended as of January 13, 2006. Incorporated herein by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 18, 2006.
|
|
10.6
|
Sixth Amended and Restated Registration Rights Agreement, dated March 3, 2004, by and among the Registrant and certain stockholders named therein. Incorporated herein by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.7**
|
Employment Agreement, dated August 11, 2002, by and between the Registrant and Ron Cohen. Incorporated herein by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.8**
|
Amendment to August 11, 2002 Employment Agreement, dated September 26, 2005, by and between the Registrant and Ron Cohen. Incorporated herein by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.9** | Letter Agreement, dated November 30, 2004, by and between the Registrant and Mark Pinney. Incorporated herein by reference to Exhibit 10.7 to the Registrant's Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005. |
10.10**
|
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and Andrew R. Blight. Incorporated herein by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
|
10.11**
|
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and Mary Fisher. Incorporated herein by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
|
10.12**
|
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and David Lawrence. Incorporated herein by reference to Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
|
10.13**
|
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and Jane Wasman. Incorporated herein by reference to Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
|
10.14
|
Amended and Restated License Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation, plc. Incorporated herein by reference to Exhibit 10.14 to the Registrant’s Amendment No. 1 to its Quarterly Report on Form 10-Q/A filed on July 20, 2011.
|
|
10.15*
|
Supply Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation, plc. Incorporated herein by reference to Exhibit 10.15 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006
|
|
10.16
|
License Agreement, dated September 26, 2003, by and between the Registrant and Rush-Presbyterian-St. Luke’s Medical Center. Incorporated herein by reference to Exhibit 10.16 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.17
|
Side Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke’s Medical Center, and Elan Corporation, plc. Incorporated herein by reference to Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.18*
|
Payment Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke’s Medical Center, and Elan Corporation, plc. Incorporated herein by reference to Exhibit 10.18 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.19*
|
Amendment No. 1 to the Payment Agreement, dated as of October 27, 2003, by and between the Registrant and Elan Corporation, plc. Incorporated herein by reference to Exhibit 10.19 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.20*
|
Amended and Restated License Agreement, dated August 1, 2003, by and between the Registrant and Canadian Spinal Research Organization. Incorporated herein by reference to Exhibit 10.20 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006
|
10.21*
|
License Agreement, dated February 3, 2003, by and between the Registrant and Cornell Research Foundation, Inc. Incorporated herein by reference to Exhibit 10.21 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.22
|
License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc. Incorporated herein by reference to Exhibit 10.22 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.23*
|
License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc. Incorporated herein by reference to Exhibit 10.23 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.24
|
License Agreement, dated September 8, 2000, by and between the Registrant and Mayo Foundation for Medical Education and Research. Incorporated herein by reference to Exhibit 10.24 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.25*
|
Side Letter Agreement, dated June 1, 2005, by and between the Registrant and Mayo Foundation for Medical Education and Research. Incorporated herein by reference to Exhibit 10.25 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.26*
|
Asset Purchase Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.26 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.27*
|
Zanaflex Supply Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharma International Limited. Incorporated herein by reference to Exhibit 10.27 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.28*
|
Assignment and Assumption Agreement, dated as of July 21, 2004, by and among the Registrant, Elan Pharmaceuticals, Inc., and Novartis Pharma AG. Incorporated herein by reference to Exhibit 10.28 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.29*
|
License Agreement, dated April 17, 1991, by and between Sandoz Pharma, now Novartis Pharma AG and Athena Neurosciences, Inc., now Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.29 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.30
|
Patent Assignment Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.24 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.31
|
Trademark License Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.25 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.32
|
Agreement Relating to Additional Trademark, dated as of July 2005, by and between the Registrant and Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.32 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
10.33
|
Domain Name Assignment Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.27 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.34
|
Bill of Sale and Assignment and Assumption Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. Incorporated herein by reference to Exhibit 10.28 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.35
|
Limited Recourse Convertible Promissory Note issued to Elan International Services, Ltd. Incorporated herein by reference to Exhibit 10.29 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.36
|
Full Recourse Convertible Promissory Note issued to Elan International Services, Ltd. Incorporated herein by reference to Exhibit 10.30 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.37
|
Note Modification and Amendment, dated as of December 23, 2005, by and between the Registrant and Elan Pharma International Limited. Incorporated herein by reference to Exhibit 10.36 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
|
10.38*
|
Fampridine Tablet Technical Transfer Program Proposal for Commercial Registration, dated February 26, 2003, by and between the Registrant and Patheon, Inc. Incorporated herein by reference to Exhibit 10.38 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.39
|
Securities Amendment Agreement, dated September 26, 2003, by and among the Registrant, Elan Corporation plc and Elan International Services, Ltd. Incorporated herein by reference to Exhibit 10.31 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.40*
|
Syndicated Sales Force Agreement, dated as of August 1, 2005, between the Registrant and Cardinal Health PTS, LLC. Incorporated herein by reference to Exhibit 10.40 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 25, 2006.
|
|
10.41
|
License Agreement, dated as of December 19, 2003, by and among the Registrant, Cambridge University Technical Services Limited, and King’s College London. Incorporated herein by reference to Exhibit 10.41 to the Registrant’s Amendment No. 1 to its Quarterly Report on Form 10-Q/A filed on July 20, 2011.
|
|
10.42
|
Promissory Note issued to General Electric Capital Corporation. Incorporated herein by reference to Exhibit 10.35 to the Registrant’s Registration Statement on Form S-1, No. 333-128827, filed on October 5, 2005.
|
|
10.43
|
Revenue Interests Assignment Agreement, dated as of December 23, 2005, between the Registrant and King George Holdings Luxembourg IIA S.à.r.l., an affiliate of Paul Royalty Fund II, L.P. Incorporated herein by reference to Exhibit 10.41 to the Registrant’s Registration Statement on Form S-1/A, No. 333-128827, filed on January 5, 2006.
|
10.44
|
Securities Purchase Agreement, dated as of October 3, 2006, by and among the Registrant and the purchasers listed on Exhibit A thereto. Incorporated herein by reference to Exhibit 10.44 of the Registrant’s Current Report on Form 8-K filed on October 5, 2006.
|
|
10.45
|
First Amendment to Revenue Interests Assignment Agreement and to Guaranty, dated November 28, 2006 by and among the Registrant, King George Holdings Luxembourg IIA S.à.r.1. and Paul Royalty Fund II, L.P. Incorporated herein by reference to Exhibit 10.45 to Registrant’s Current Report on Form 8-K filed on November 29, 2006.
|
|
10.46**
|
Amendment to August 11, 2002 Employment Agreement, dated May 10, 2007, by and between the Registrant and Ron Cohen. Incorporated herein by reference to Exhibit 10.1 to Registrant’s Quarterly Report on Form 10-Q filed on May 14, 2007.
|
|
10.47**
|
Amendment to December 19, 2005 Employment Agreement, dated May 10, 2007, by and between the Registrant and Andrew R. Blight. Incorporated herein by reference to Exhibit 10.2 to Registrant’s Quarterly Report on Form 10-Q filed on May 14, 2007.
|
|
10.48**
|
Amendment to December 19, 2005 Employment Agreement, dated May 10, 2007, by and between the Registrant and Mary Fisher. Incorporated herein by reference to Exhibit 10.3 to Registrant’s Quarterly Report on Form 10-Q filed on May 14, 2007.
|
|
10.49**
|
Amendment to December 19, 2005 Employment Agreement, dated May 10, 2007, by and between the Registrant and David Lawrence. Incorporated herein by reference to Exhibit 10.4 to Registrant’s Quarterly Report on Form 10-Q filed on May 14, 2007.
|
|
10.50**
|
Amendment to December 19, 2005 Employment Agreement, dated May 10, 2007, by and between the Registrant and Jane Wasman. Incorporated herein by reference to Exhibit 10.5 to Registrant’s Quarterly Report on Form 10-Q filed on May 14, 2007.
|
|
10.51
|
Registration Rights Agreement, dated as of February 1, 2008, by and among the Registrant and Edward A. Labry III. Incorporated herein by reference to Exhibit 10.51 to Registrant’s Annual Report on Form 10-K filed on March 14, 2008.
|
|
10.52**
|
Amendment to August 11, 2002 Employment Agreement dated December 28, 2007, by and between the Registrant and Ron Cohen. Incorporated herein by reference to Exhibit 10.52 to Registrant’s Annual Report on Form 10-K filed on March 14, 2008.
|
|
10.53**
|
Employment Offer Letter, dated October 20, 2008, by and between the Registrant and Thomas C. Wessel. Incorporated herein by reference to Exhibit 10.53 to Registrant’s Annual Report on Form 10-K filed on March 2, 2009.
|
|
10.54*
|
Collaboration and License Agreement Between Biogen Idec International GmbH and the Registrant dated June 30, 2009. Incorporated herein by reference to Exhibit 10.54 to Registrant’s Quarterly Report on Form 10-Q filed on August 10, 2009.
|
|
10.55*
|
Supply Agreement Between Biogen Idec International GmbH and the Registrant dated June 30, 2009. Incorporated herein by reference to Exhibit 10.55 to Registrant’s Quarterly Report on Form 10-Q filed on August 10, 2009.
|
10.56
|
Amendment No. 1 Agreement and Sublicense Consent Between Elan Corporation, plc and the Registrant dated June 30, 2009. Incorporated herein by reference to Exhibit 10.56 to Registrant’s Quarterly Report on Form 10-Q filed on August 10, 2009.
|
|
10.57**
|
Employment Offer Letter, dated January 22, 2010, by and between the Registrant and Lauren Sabella. Incorporated herein by reference to Exhibit 10.57 to Registrant’s Quarterly Report on Form 10-Q filed on May 10, 2010.
|
|
10.58**
|
Forms of Equity Award Documents. Incorporated herein by reference to Exhibit 10.58 to Registrant’s Annual Report on Form 10-K filed on March 1, 2011.
|
|
10.59*
|
Development and Supplemental Agreement between Elan Pharma International Limited and the Registrant dated January 14, 2011. Incorporated by reference to Exhibit 10.59 to Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2011.
|
|
10.60*
|
Amendment #1 to License Agreement among the Registrant, Cambridge Enterprise Limited (formerly Cambridge University Technical Services Limited), and Kings College London dated as of March 4, 2011. Incorporated by reference to Exhibit 10.60 to Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2011.
|
|
10.61**
|
Amendment to August 11, 2002 Employment Agreement dated June 21, 2011, by and between the Registrant and Ron Cohen. Incorporated by reference to Exhibit 10.61 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.62
|
Lease, dated as of June 23, 2011, by and between the Registrant and BMR-Ardsley Park LLC. Incorporated by reference to Exhibit 10.62 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.63*
|
License Agreement, dated as of June 27, 2011, by and between the Registrant and Medtronic, Inc. and Warsaw Orthopedic, Inc. Incorporated by reference to Exhibit 10.63 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.64**
|
Employment Offer Letter, dated August 18, 2011, by and between the Registrant and Enrique Carrazana.
|
|
10.65** |
Consulting Agreement effective as of October 1, 2011, by and between the Registrant and Thomas C. Wessel.
|
|
10.66**
|
Letter agreement dated October 19, 2011, by and between the Registrant and Enrique Carrazana.
|
|
10.67**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and Andrew R. Blight.
|
|
10.68**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and David Lawrence.
|
|
10.69**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and Jane Wasman.
|
|
10.70**
|
Letter agreement dated November 7, 2011, by and between the Registrant and Lauren Sabella.
|
|
10.71** |
Separation Agreement and General Release dated November 21, 2011, by and between the Registrant and Thomas C. Wessel.
|
|
21
|
List of Subsidiaries of the Registrant.
|
23.1
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
|
|
23.2
|
Consent of KPMG LLP, Independent Registered Public Accounting Firm.
|
|
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
32.1
|
Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS***
|
XBRL Instance Document
|
|
101.SCH***
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL***
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF***
|
XBRL Taxonomy Extension Definition Document
|
|
101.LAB***
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE***
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*
|
Confidential treatment granted as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission.
|
**
|
Indicates management contract or compensatory plan or arrangement.
|
***
|
In accordance with Regulation S-T, the XBRL-related information in Exhibit 101 to this Annual Report on Form 10-K shall be deemed to be “furnished” and not “filed.”
|
Acorda Therapeutics, Inc.
|
||
By:
|
/s/
Ron Cohen
Ron Cohen
President and Chief Executive Officer
|
Signature
|
Title
|
Date
|
|||||||
/s/
Ron
Cohen
, M.D.
Ron Cohen, M.D.
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
February 28, 2012
|
|||||||
/s/
David Lawrence, M.B.A.
David Lawrence, M.B.A.
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
February 28, 2012
|
|||||||
/s/
Barry Greene
Barry Greene
|
Director
|
February 28, 2012
|
|||||||
/
s/ Peder K. Jensen
Peder K. Jensen
|
Director
|
February 28, 2012
|
|||||||
/s/
John P. Kelley
John P. Kelley
|
Director
|
February 28, 2012
|
|||||||
/s/
Sandra Panem, Ph.D.
Sandra Panem, Ph.D.
|
Director
|
February 28, 2012
|
|||||||
/s/
Lorin J. Randall
Lorin J. Randall
|
Director
|
February 28, 2012
|
|||||||
/s/
Steven M. Rauscher, M.B.A.
Steven M. Rauscher, M.B.A.
|
Director
|
February 28, 2012
|
|||||||
/s/
Ian Smith
Ian Smith
|
Director
|
February 28, 2012
|
|
Number
|
Description
|
|
3
.2
|
Bylaws of the Registrant, as amended on December 15, 2011.
|
|
10.64**
|
Employment Offer Letter, dated August 18, 2011, by and between the Registrant and Enrique Carrazana, M.D.
|
|
10.65** |
Consulting Agreement effective as of October 1, 2011, by and between the Registrant and Thomas C. Wessel.
|
|
10.66**
|
Letter agreement dated October 19, 2011, by and between the Registrant and Enrique Carrazana, M.D.
|
|
10.67**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and Andrew R. Blight.
|
|
10.68**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and David Lawrence.
|
|
10.69**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and Jane Wasman.
|
|
10.70**
|
Letter agreement dated November 7, 2011, by and between the Registrant and Lauren Sabella.
|
|
10.71** |
Separation Agreement and General Release dated November 21, 2011, by and between the Registrant and Thomas C. Wessel.
|
|
21
|
List of Subsidiaries of the Registrant.
|
|
23.1
|
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
|
|
23.2
|
Consent of KPMG LLP, Independent Registered Public Accounting Firm.
|
|
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the
Securities Exchange Act of 1934.
|
|
32.1
|
Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS***
|
XBRL Instance Document
|
|
101.SCH***
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL***
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF***
|
XBRL Taxonomy Extension Definition Document
|
|
101.LAB***
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE***
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
______________________
|
||
**
|
Indicates management contract or compensatory plan or arrangement.
|
|
***
|
In accordance with Regulation S-T, the XBRL-related information in Exhibit 101 to this Annual Report on Form 10-K shall be deemed to be “furnished” and not “filed.”
|
|
2.
|
You will receive a signing bonus of $100,000; $50,000 payable within the first 30 days of your start date and the remaining $50,000 after one year of employment. If, within the first twelve months of employment, you voluntarily terminate your employment with the Company, you agree to reimburse the Company on a prorated basis.
|
|
4.
|
You will be eligible to participate in the Company’s benefit plans one month from your hire date.
|
|
6.
|
You will be eligible for 5 days of PTO for 2011. Effective January 1, 2012 you will be eligible for 15 days of PTO.
|
|
7.
|
You will receive a base grant of 75,000 options of Acorda common stock, vesting over four years. In accordance with the Company’s standard option grant procedures, the first 25% of your options will vest at the end of your first 12 months of employment, and the remaining 75% will vest on a quarterly basis over the remaining three years. The grant date will be determined as your new hire start date, assuming you actually start on that date. The strike price will be the market price of the stock at the close of business on the date of grant.
|
|
8.
|
In addition, you will receive 25,000 shares of restricted stock of Acorda common stock, vesting annually over a three-year period as follows: 1/3 of the grant will vest October 15, 2012, 1/3 on October 15, 2013 and 1/3 on October 15, 2014. Restricted shares are subject to the additional terms and conditions of the Acorda Restricted Share Certificate approved by the Board.
|
|
9.
|
In addition to a year-end performance review, you will be eligible to participate in the Company’s Merit Increase Program, Annual Cash Bonus Program and Acorda Equity Program with a potential to receive a pro-rated, merit increase, cash bonus and equity grant. Your Annual Cash Bonus Program target is 40% of base salary and is based on the Company’s performance against the Corporate Goals and individual/team performance against goals established for that bonus year. Bonus targets include a possible range of zero and can exceed 100% for an individual/team goal or in aggregate.Eighty percent of your target is attributed
to Company performance and twenty percent is attributed to individual/team performance. The Annual Cash Bonus Program and the Acorda Equity Program are subject to approval by the Board of Directors.
|
|
10.
|
If you relocate within twelve months of employment, you will receive our full relocation package to include house hunting trips, commissions on the sale of residence (not to exceed 6%), legal fees associated with the sale of residence, legal fees associated with the purchase of a new residence and fees for securing a mortgage on a new residence to include appraisal fee, credit report, processing
fee, underwriting fee, title insurance, recording fee, but to exclude pre-paid points, interest expense and property taxes, and the move of your goods to the new location. In addition, you will receive temporary living assistance to include for
up to one-year, an apartment and reimbursement of reasonable commuting expenses to and from Florida, such as flight accommodations not to exceed an aggregate $35,000. If within the first twelve months of relocating, you voluntarily terminate your employment with the Company, you agree to reimburse the Company for such relocation expenses and temporary living expenses on a prorated basis.
|
|
11.
|
To comply with INS regulations, please bring with you on your first day of work, proof verifying your right to work in the United States. Some examples are passport, driver’s license and Social Security card, or certificate of citizenship, etc.
|
|
12.
|
This letter is not intended, nor should it be considered, as an employment contract for a definite or indefinite period. Once employed, you will be an employee at will. This letter also constitutes the understanding between us with respect to our offer of employment, and replaces and supercedes any previous understandings or arrangements.
|
Acorda Therapeutics, Inc.
|
Thomas C. Wessel, M.D., Ph.D.
|
By:
/s/Ron Cohen, M.D.
Name: Ron Cohen, M.D.
Title: President and CEO
|
By:
/s/Thomas C. Wessel, M.D., Ph.D.
Thomas C. Wessel, M.D., Ph.D.
|
·
|
Taxi/Sedans/Limousines to and/or from the Company, Consultant’s place of business (excluding taxis to and/or from airports for the Company-requested business)
|
·
|
Air travel other than coach class
|
·
|
Travel time
|
·
|
Add-on costs with respect to outside services
|
·
|
Mark-up on the work product of outside professionals, including but not limited to freelancers
|
·
|
Lunches and dinners
|
·
|
Administrative and/or overhead percentages
|
·
|
Presentations for new business
|
·
|
Gifts to the Company employees
|
·
|
Entertainment of the Company employees
|
·
|
Mark-up on out-of-pocket expenses
|
Note:
|
This list sets forth the major items for which the Company will not reimburse Consultant and is meant to be merely illustrative and not exhaustive. All of Consultant’s expenses shall be reviewed with respect to the reasonableness of such expenses.
|
|
(i)
|
committed gross negligence in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company;
|
|
(ii)
|
committed fraud in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company;
|
|
(iii)
|
engaged in “willful misconduct” with respect to the business and affairs of the Company. For purposes of this Agreement, “willful misconduct” means misconduct committed with actual knowledge that your actions violate directions and instructions of the CEO, which directions and instructions are legal and consistent with the terms of your employment;
|
|
(iv)
|
materially breached your duties to the Company or failed to materially comply with the Company’s policies and practices; or
|
|
(v)
|
committed an act of moral turpitude, theft, dishonesty or insubordination.
|
|
(i)
|
a material diminution in your base salary;
|
|
(ii)
|
a material diminution in your authority, duties, or responsibilities;
|
|
(iii)
|
a material diminution in the authority, duties, or responsibilities of the supervisor to whom you report;
|
|
(iv)
|
a material diminution in the budget over which you retain authority;
|
|
(v)
|
a material change in the geographic location at which you must perform the services; and
|
|
(vi)
|
any other action or inaction that constitutes a material breach by the Company of this Agreement.
|
(c)
|
Change in Control.
As used herein, “Change of Control” shall be deemed to have occurred if:
|
|
(i)
|
there is a consolidation or merger of the Company in which the Company is not the continuing or surviving corporation; or there is any other merger or consolidation if, after such merger or consolidation shareholders of the Company immediately prior to such merger or consolidation hold less than 50% of the voting stock of the surviving entity;
|
|
(ii)
|
there is a sale or transfer of all or substantially all of the assets of the Company in one or a series of transactions or there is a complete liquidation or dissolution of the Company; or
|
|
(iii)
|
any individual or entity or group acting in concert and affiliates thereof, acquires, directly or indirectly, more than 50% of the outstanding shares of voting stock of the Company; provided that this subsection (iii) shall not apply to an underwritten public offering of the Company’s securities.
|
Very truly yours,
|
||
Acorda Therapeutics, Inc.
|
||
By:
|
/s/ Ron Cohen
|
|
Ron Cohen
|
||
Its:
|
President & CEO
|
Agreed to and accepted:
|
||
/s/ Enrique Carrazana
|
||
Enrique Carrazana
|
||
Very truly yours,
|
||
Acorda Therapeutics, Inc.
|
||
By:
|
/s/Ron Cohen
|
|
Ron Cohen
|
||
Its:
|
President & CEO
|
Agreed to and accepted:
|
||
/s/ Andrew Blight
|
||
Andrew Blight
|
||
Very truly yours,
|
||
Acorda Therapeutics, Inc.
|
||
By:
|
/s/ Ron Cohen
|
|
Ron Cohen
|
||
Its:
|
President & CEO
|
Agreed to and accepted:
|
||
/s/ David Lawrence
|
||
David Lawrence
|
||
Very truly yours,
|
||
Acorda Therapeutics, Inc.
|
||
By:
|
/s/ Ron Cohen
|
|
Ron Cohen
|
||
Its:
|
President & CEO
|
Agreed to and accepted:
|
||
/s/ Jane Wasman
|
||
Jane Wasman
|
||
|
(i)
|
committed gross negligence in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company;
|
|
(ii)
|
committed fraud in connection with your duties as set forth herein or otherwise with respect to the business and affairs of the Company;
|
|
(iii)
|
engaged in “willful misconduct” with respect to the business and affairs of the Company. For purposes of this Agreement, “willful misconduct” means misconduct committed with actual knowledge that your actions violate directions and instructions of the CEO, which directions and instructions are legal and consistent with the terms of your employment;
|
|
(iv)
|
materially breached your duties to the Company or failed to materially comply with the Company’s policies and practices; or
|
|
(v)
|
committed an act of moral turpitude, theft, dishonesty or insubordination.
|
|
(i)
|
a material diminution in your base salary;
|
|
(ii)
|
a material diminution in your authority, duties, or responsibilities;
|
|
(iii)
|
a material diminution in the authority, duties, or responsibilities of the supervisor to whom you report;
|
|
(iv)
|
a material diminution in the budget over which you retain authority;
|
(v)
|
a material change in the geographic location at which you must perform the services; and
|
|
(vi)
|
any other action or inaction that constitutes a material breach by the Company of this Agreement.
|
(c)
|
Change in Control.
As used herein, “Change of Control” shall be deemed to have occurred if:
|
|
(i)
|
there is a consolidation or merger of the Company in which the Company is not the continuing or surviving corporation; or there is any other merger or consolidation if, after such merger or consolidation shareholders of the Company immediately prior to such merger or consolidation hold less than 50% of the voting stock of the surviving entity;
|
|
(ii)
|
there is a sale or transfer of all or substantially all of the assets of the Company in one or a series of transactions or there is a complete liquidation or dissolution of the Company; or
|
|
(iii)
|
any individual or entity or group acting in concert and affiliates thereof, acquires, directly or indirectly, more than 50% of the outstanding shares of voting stock of the Company; provided that this subsection (iii) shall not apply to an underwritten public offering of the Company’s securities.
|
Very truly yours,
|
||
Acorda Therapeutics, Inc.
|
||
By:
|
/s/ Ron Cohen
|
|
Ron Cohen
|
||
Its:
|
President & CEO
|
Agreed to and accepted:
|
||
/s/ Lauren Sabella
|
||
Lauren Sabella
|
||
1.
|
I have reviewed this annual report on Form 10-K of Acorda Therapeutics, 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(s) 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 the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
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.
|
/s/
Ron Cohen
Ron Cohen
Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this annual report on Form 10-K of Acorda Therapeutics, 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(s) 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 the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
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.
|
/s/
David Lawrence
David Lawrence
Chief Financial Officer
(Principal Financial Officer)
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|