Acorda Therapeutics, Inc. - Annual Report: 2011 (Form 10-K)

 

 

 

 

 

 

 

		Page
PART I		1
Item 1.	Business	1
Item 1A.	Risk Factors	38
Item 1B.	Unresolved Staff Comments	62
Item 2.	Properties	62
Item 3.	Legal Proceedings	63
Item 4.	Mine Safety Disclosures	63
PART II		64
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	64
Item 6.	Selected Financial Data	66
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	68
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	92
Item 8.	Financial Statements and Supplementary Data	93
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosures	93
Item 9A.	Controls and Procedures	93
Item 9B.	Other Information	96
PART III		96
Item 10.	Directors, Executive Officers and Corporate Governance	96
Item 11.	Executive Compensation	96
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	96
Item 13.	Certain Relationship and Related Transactions, and Director Independence	96
Item 14.	Principal Accounting Fees and Services	96
PART IV		97
Item 15.	Exhibits and Financial Statement Schedules	97
SIGNATURES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·

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.

·

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.

·

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.

·

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.

·

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.

o

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.

o

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.

o

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.

·

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

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.

·

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.

·

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.

 

 

 

 

·

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.

 

·	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.

 

·	Support the efforts of our collaboration partner, Biogen Idec, in seeking health authority approval for and commercializing Fampyra in markets outside the U.S.

 

·	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.

 

·	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.

 

Commercial Products		Indication		Status		Marketing Rights
Ampyra		MS		FDA-approved and marketed in the U.S.		Acorda (U.S.)
Fampyra		MS		Approved in EU (conditional), Australia, Canada, and New Zealand; launched in Germany, U.K. and a number of other EU countries and in Australia		Biogen Idec (outside U.S.)
Zanaflex Capsules		Spasticity		FDA-approved		Acorda (U.S.)
Zanaflex tablets		Spasticity		FDA-approved		Acorda (U.S.)
Research and Development Programs		Proposed Therapeutic Area(s)		Stage of Development		Marketing Rights
Dalfampridine		Cerebral Palsy		Phase 2 proof-of-concept clinical trial commenced December 2011		Acorda (U.S.)
Dalfampridine		Chronic Stroke		Phase 2 proof-of-concept clinical trial expected to begin H2 2012		Acorda (U.S.)
AC105		SCI and TBI		Acute SCI Phase 2 clinical trial expected to begin in H2 2012		Acorda/Worldwide
Neuregulin Program		Heart failure*		GGF2 Phase 1 clinical trial ongoing; initial results expected H2 2012		Acorda/Worldwide
Remyelinating Antibodies Program		MS		rHIgM22 IND filing expected H1 2012; Phase 1 clinical trial expected to begin in H2 2012		Acorda/Worldwide
Chondroitinase Program		SCI		Research		Acorda/Worldwide

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	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.

·

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

            

·	preclinical laboratory and animal tests;

·	submission to the FDA of an Investigational New Drug, or IND, an application which must become effective before human clinical trials may begin;

 

·	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);

 

·	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

 

·

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.

 

 

 

 

 

 

 

·	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.

 

·	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.

 

·

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	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.;

 

·	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

 

·	continuing to advance clinical development of our AC105 and GGF2 programs, and advance rHIgM22 into clinical trials;

 

·	continuing to develop our preclinical product candidates and advance them into clinical trials; and

 

·	evaluating and potentially expanding our product development pipeline through the potential in-licensing and/or acquisition of additional products and technologies.

 

 

 

 

 

 

 

 

 

·	the effectiveness of our sales, managed markets and marketing efforts;

 

·	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;

 

·	the availability of adequate reimbursement by third-party payers;

 

·	the continued use of compounded dalfampridine, instead of Ampyra, available through pharmacies in the U.S. and elsewhere that engage in compounding;

 

·	the occurrence of any side effects, adverse reactions or misuse (or any unfavorable publicity relating thereto) stemming from the use of Ampyra; and

 

·	the development of competing products or therapies for the treatment of MS or its symptoms.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	sales of Ampyra may be significantly decreased from projected sales;

 

·	regulatory approvals for Ampyra may be restricted or withdrawn;

 

·	we may decide to, or be required to, send product warning letters or field alerts to physicians, pharmacists and hospitals;

 

·	reformulation of the product, additional preclinical or clinical studies, changes in labeling or changes to or reapprovals of manufacturing facilities may be required;

 

·	our reputation in the marketplace may suffer; and

 

·	government investigations and lawsuits, including class action suits, may be brought against us.

 

 

 

 

 

 

 

 

 

 

 

·	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;

 

·	not effectively sell or support Ampyra;

 

·	reduce their efforts or discontinue selling or supporting Ampyra;

 

·	not devote the resources necessary to sell Ampyra in the volumes and within the time frames that we expect;

 

·	be unable to satisfy financial obligations to us or others;

 

·	not have the required licenses to distribute drugs; or

 

·	cease operations.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	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;

 

·	collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all;

 

·	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;

 

·	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;

 

·	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;

 

·	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;

 

·	a collaborator could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors;

 

·	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

 

·	collaborators may experience financial difficulties.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	negative or ambiguous results regarding the efficacy of the product candidate;

 

·	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;

 

·	inability to locate, recruit and qualify a sufficient number of patients for our trials;

 

·	difficulty in determining meaningful end points or other measurements of success in our clinical trials;

 

·	regulatory delays or other regulatory actions, including changes in regulatory requirements;

 

·	difficulties in obtaining sufficient quantities of our product candidates manufactured under current good manufacturing practices;

 

·	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;

 

·	FDA approval of new drugs that are more effective than our product candidates;

 

·	change in the focus of our development efforts or a re-evaluation of our clinical development strategy; and

 

·	change in our financial position.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         We also are subject to periodic unannounced inspections by the FDA and other regulatory bodies related to other regulatory requirements that apply to drugs manufactured or distributed by us. If we receive a notice of inspectional observations or deficiencies from the FDA, we may be required to undertake corrective and preventive actions in order to address the FDA's concerns, which could be expensive and time-consuming to complete and could impose additional burdens and expenses on how we conduct the affected activities.  For example, the FDA conducted two inspections beginning in July 2011.  The first inspection focused on our REMS and the second inspection focused on our adverse event reporting system.  The REMS inspection resulted in verbal comments pertaining to formalization of procedures and enhanced quality assurance responsibilities.  The adverse event reporting inspection resulted in an FDA Form 483 focused primarily on timeliness of reporting, formalization and enhancement of certain procedures and processes, communication of Ampyra post-marketing commitments, and Acorda access to source documentation.  Acorda has provided the FDA with formal responses to the inspectional observations as well as to the verbal comments and is in the process of implementing specific actions to address the FDA’s concerns and enhance our overall pharmacovigilance process.  We have met each of our obligations on time through the end of 2011.  Nevertheless, the FDA may decide that our responses and corrective actions are not adequate and may decide to issue a written warning letter or take other enforcement action. In addition, although Ampyra was approved by the FDA on January 22, 2010, the FDA has not inspected our third-party suppliers’ drug product manufacturing sites in connection with that approval.  The process validation efforts and manufacturing process at these sites could be inspected at a later date and the FDA might find what it considers to be deficiencies in the manufacturing process or process validation efforts, which could negatively impact the availability of product supply.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	rate of adoption by healthcare practitioners;

 

·	rate of a product’s acceptance by the target population,

 

·	timing of market entry relative to competitive products,

 

·	availability of alternative therapies,

 

·	perceived advantages of alternative therapies,

 

·	price of product relative to alternative therapies,

 

·	extent of marketing efforts,

 

·	unavailability of adequate reimbursement by third parties, and

 

·	side effects or unfavorable publicity concerning the products or similar products.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	substantial cash expenditures;

 

·	potentially dilutive issuance of equity securities;

 

·	incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;

 

·	difficulties in assimilating the operations of the acquired companies;

 

·	diverting our management’s attention away from other business concerns;

 

·	entering markets in which we have limited or no direct experience; and

 

·	potential loss of our key employees or key employees of the acquired companies or businesses.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	voluntary or mandatory recalls;

 

·	voluntary or mandatory patient or physician notification;

 

·	withdrawal of product approvals;

 

·	product seizures;

 

·	restrictions on, or prohibitions against, marketing our products;

 

·	restrictions on importation of our product candidates;

 

·	fines and injunctions;

 

·	civil and criminal penalties;

 

·	exclusion from participation in government programs; and

 

·	suspension of review or refusal to approve pending applications.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	pay substantial damages;

 

·	stop using our technologies;

 

·	withdraw a product from the market;

 

·	stop certain research and development efforts;

 

·	significantly delay product commercialization activities;

 

·	develop non-infringing products or methods, which may not be feasible; and

 

·	obtain one or more licenses from third parties.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	achievement or rejection of regulatory approvals by us or our collaborators or by our competitors;

 

·	publicity regarding actual or potential clinical trial results or updates relating to products under development by us, our collaborators, or our competitors;

 

·	announcements of new corporate partnerships, alliances, financings or other transactions, or of technological innovations or new commercial products by our competitors or by us;

 

·	developments concerning proprietary rights, including patents;

 

·	developments concerning our collaborations;

 

·	economic or other crises or other external factors;

 

·	conditions or trends in the pharmaceutical or biotechnology industries;

 

·	litigation and other developments relating to our patents or other proprietary rights or those of our collaborators or competitors;

 

·	governmental regulation and legislation in the U.S. and foreign countries;

 

·	changes in securities analysts' estimates of our performance or our failure to meet analysts' expectations;

 

·	sales of substantial amounts of our stock;

 

·	delay or failure in initiating, completing or analyzing pre-clinical trials or unsatisfactory design or result of these trials;

 

·	variations in product revenue and profitability;

 

·	variations in our anticipated or actual operating results; and

 

·	changes in healthcare reimbursement policies.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·	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.

 

·

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.

 

·

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.

 

·	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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

		High				Low
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		$	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