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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, 2012
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OR
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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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420 Saw Mill River Road
Ardsley, New York 10502
(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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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
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Accelerated filer
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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 p
roduct 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 $266.1 million for the year ended December 31, 2012, with more than 73,000 new patients trying Ampyra therapy since the 2010 launch. As of December 31, 2012, 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 have been dispensed at least six months of the medicine through refills, consistent with previously reported trends. Three of the largest national health plans in the U.S. – Aetna, United Healthcare and Cigna – have listed Ampyra in the lowest branded co-pay tier of their commercial preferred drug list or formulary. This formulary status at all three health plans was renewed in 2012.
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Ampyra Development Programs:
We are studying dalfampridine to improve a range of functional impairments, in addition to walking disability, caused by MS, as well as its potential use in other neurological conditions, including cerebral palsy, or CP, and post-stroke deficits. In December 2011, we initiated a Phase 2 proof-of-concept clinical study of dalfampridine in adults with CP. The first phase of this proof-of-concept study, which has been completed, was a single-dose phase primarily to evaluate safety and tolerability prior to proceeding to a multi-dose cohort. This 10-person, single dose phase of the study detected no safety signals that would prevent additional study of the drug in the treatment of CP. We completed enrollment for the second phase, a multi-dose study including 20 adults with CP, to evaluate both safety and efficacy. We expect to announce topline results of this phase of the study in the second quarter of 2013. Also, in June 2012, we enrolled the first patient in a Phase 2 proof-of-concept trial of dalfampridine in post-stroke deficits, and we expect to announce topline study results in the second quarter of 2013. This study is exploring the use of dalfampridine in patients who have experienced a stroke and who have stabilized with chronic neurologic deficits, which may include walking impairment and upper extremity function impairment, such as arm weakness. Over the first six months following a stroke, patients typically show some degree of spontaneous recovery of function, which may be enhanced by rehabilitation and physical therapy. This trial is targeting motor impairments that remain after such recovery. We also are providing grants for investigator-initiated studies exploring potential benefits on a range of functional deficits in MS and other neurological disorders.
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Ampyra Patents:
We have two issued patents listed in the Orange Book for Ampyra. The first is U.S. Patent No. US 8,007,826 with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Based on the final patent term adjustment calculation of the United States Patent and Trademark Office, or USPTO, this patent will extend into 2027. The second is U.S. Patent No. 5,540,938 (“the ‘938 patent”), the claims of which relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. In October 2012, the USPTO determined that the ‘938 patent is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act. With a five year patent term extension, the ‘938 patent would expire in 2018.
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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. Fampyra is commercially available in a number of European Union countries and in Canada, Australia, New Zealand and Israel, and Biogen Idec anticipates making Fampyra commercially available in additional markets in 2013, as well as filing for regulatory approval in other countries. We recorded $7.1 million of royalty revenue and $9.1 million of amortized license revenue in 2012 related to Fampyra.
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Zanaflex Capsules and Zanaflex tablets:
Our Zanaflex Capsules 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. We launched Zanaflex Capsules in April 2005 as part of our strategy to build a commercial platform for the potential market launch of Ampyra. In February 2012, Apotex Inc. commercially launched a generic version of tizanidine hydrochloride capsules, and we also launched our own authorized generic version, which is being marketed by Watson Pharma, Inc., a subsidiary of Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.). Net revenues for our Zanaflex franchise including our own authorized generic version were $23.5 million for the year ended December 31, 2012. The commercial launch of generic tizanidine hydrochloride capsules has caused a significant decline in net revenue of Zanaflex Capsules, and the launch of these generic versions and the potential launch of other generic versions are expected to cause our net revenues from Zanaflex Capsules to further decline in 2013 and beyond. In May 2012, we received a Paragraph IV Certification Notice from Mylan Laboratories Limited advising us that Mylan Laboratories has filed an Abbreviated New Drug Application for generic versions of the three dosage strengths of Zanaflex Capsules. The FDA approved Mylan’s ANDA on November 9, 2012. Based upon our request, the FDA delisted from the Orange Book the patent against which Mylan Laboratories filed the Paragraph IV Certification Notice.
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Research and Development Programs:
Our lead research and development programs include three distinct therapeutic approaches to restoring neurologic function– neuregulins, remyelinating antibodies and chondroitinase, our program to develop AC105 as an acute treatment for neurological trauma, and our recently acquired program to develop Diazapam Nasal Spray as a treatment for selected, refractory patients with epilepsy, on stable regimens of antiepileptic drugs, or AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity also known as cluster or acute repetitive seizures, or ARS.
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o
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Neuregulins:
GGF2 is our lead product candidate for our neuregulins program. We have completed a Phase 1 clinical trial of GGF2 in heart failure patients. This was a dose-escalating trial designed to test the maximum tolerated single dose, with follow-up assessments at one, three, and six months. We have completed analysis of the three-month data, and we plan to present findings in a platform presentation at the American College of Cardiology (ACC) annual meeting in March 2013. We will also discuss the data with the FDA before proceeding to a multiple dose study. 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 independently or we may decide to enter into a partnership, most likely with a cardiovascular-focused company. 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 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. We have an open IND for rHIgM22 for the treatment of MS and plan to initiate enrollment in a Phase 1 safety study in MS patients in the first half of 2013.
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AC105:
AC105 is a proprietary magnesium formulation that we are studying as an acute treatment for SCI. We licensed AC105 from Medtronic, Inc. and one of its affiliates in 2011. 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. We submitted a Phase 2 clinical trial protocol for AC105 for acute treatment of SCI to the FDA for review. The protocol has been reviewed by the FDA, and we are preparing to initiate the trial in the first half of 2013.
The trial is designed primarily to assess the safety and tolerability of AC105 in people with acute SCI. In January 2013, we announced that the U.S. Department of Defense awarded us a $2.67 million research contract to support this Phase 2 trial. The FDA granted Fast Track designation for AC105 to improve functional recovery of acute SCI.
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o
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Neuronex Acquisition:
In February 2012, we signed an agreement to acquire Neuronex, Inc., a privately-held pharmaceutical company developing a proprietary nasal spray formulation of diazepam as an acute treatment for selected, refractory patients with epilepsy, on stable regimens of antiepileptic drugs, or AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity also known as cluster or acute repetitive seizures, or ARS. We completed the acquisition of Neuronex in December 2012. Continuing with efforts commenced by Neuronex prior to the acquisition, pending additional clinical and manufacturing data, we plan to submit a 505(b)(2)-type New Drug Application, or NDA, for Diazepam Nasal Spray, to the FDA in 2013, with potential FDA approval and commercial launch in 2014. We anticipate that our current infrastructure can support sales and marketing of this product, and market planning is underway. A 505(b)(2) application allows for an NDA that references medical literature and the FDA’s finding of safety and effectiveness for a previously approved drug product. We believe this is an important addition to our pipeline that aligns with our core strategy to develop and commercialize products that offer unique benefits to people with neurological diseases. This acquisition has provided a near-term commercial opportunity in neurology that leverages our existing sales, marketing and medical organizations. Financial terms of the acquisition are described below in the “Research and Development Programs” section of this report.
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Corporate Headquarters:
In July 2012, we relocated our corporate headquarters, and all employees then based at our Hawthorne, N.Y. location, to a facility in Ardsley, New York consisting of an aggregate of approximately 138,000 square feet of office and laboratory space. We have grown substantially over the last several years, and the new facility provides state-of-the art office and laboratory space that will accommodate our current needs and allow for future growth.
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Corporate Update:
In October 2012, we named Jane Wasman, J.D., as President, International. Prior to her October 2012 promotion, Ms. Wasman served as our Chief, Strategic Development, General Counsel and Corporate Secretary. In her new role, Ms. Wasman leads our efforts to identify and launch inlicensing and commercial opportunities outside the United States. She is also responsible for managing our collaboration with Biogen Idec in their international development and commercialization of Fampyra (prolonged-release fampridine tablets). Ms. Wasman also continues to lead our global strategic development and has retained the titles of General Counsel and Secretary.
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Continue to invest in growing Ampyra sales, with focus in 2013 on:
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Implementing sales and marketing programs that increase awareness and use in patients with earlier stages of walking disability who can benefit from Ampyra, and that are aimed at increasing adherence to the prescribed therapy by patients who are benefitting from it. We expect that, for 2013, we will not be increasing our investment in Ampyra commercial activities above 2012 levels as a percentage of product sales.
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Educating prescribers on the value of Ampyra for earlier-stage patients.
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Expanding our reimbursement specialist programs, which provide assistance to physicians’ offices in navigating managed care challenges.
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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 post-stroke deficits.
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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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Advance our pipeline of research and development programs, and for 2013 in particular achieving the milestones described above under “Company Highlights.”
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Expand our pipeline through the potential inlicensing and/or acquisition of select products and technologies in neurology, with our focus
through 2013
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 the EU (conditional) and other countries; commercially available in a number of EU countries and in Canada, Australia, New Zealand and Israel.
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Biogen Idec (outside U.S.)
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Zanaflex Capsules and an authorized generic version of the capsules
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Spasticity
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FDA-approved
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Acorda (U.S.); authorized generic marketed by Actavis/Watson Pharma
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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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Diazapam Nasal Spray
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Cluster/Acute Repetitive Seizures
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NDA preparations ongoing; filing planned for 2013 pending additional clinical and manufacturing data
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Acorda/Worldwide (excluding certain Asian countries)
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Dalfampridine
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Cerebral Palsy
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Phase 2 proof-of-concept clinical trial
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Acorda/Worldwide (Biogen ex-U.S. option)
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Dalfampridine
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Post-Stroke Deficits
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Phase 2 proof-of-concept clinical trial
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Acorda/Worldwide (Biogen ex-U.S. option)
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AC105
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SCI and TBI
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Acute SCI Phase 2 clinical trial preparations ongoing; expect to initiate trial in H1 2013
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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 completed
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Acorda/Worldwide
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Remyelinating Antibodies Program
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MS
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Open IND for rHIgM22; Phase 1 clinical trial expected to begin H1 2013
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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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The first is U.S. Patent No. US 8,007,826 with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Based on the final patent term adjustment calculation of the United States Patent and Trademark Office, or USPTO, this patent will extend into 2027.
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The second is U.S. Patent No. 5,540,938 (“the ‘938 patent”), the claims of which relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking
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in people with MS. In October 2012, the USPTO determined that the ‘938 patent is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act. With a five year patent term extension, the ‘938 patent would expire in 2018.
We have an exclusive license to this patent from Alkermes (originally with Elan, but transferred to Alkermes as part of its acquisition of Elan’s Drug Technologies business).
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We have an exclusive, worldwide license from the Canadian Spinal Research Organization for specified patents and know-how relating to the use of dalfampridine in the reduction of chronic pain and spasticity in a spinal cord injured subject.
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We have an exclusive, worldwide license from Cambridge Enterprise Limited (formerly Cambridge University Technical Services Limited) and King's College London to specified patents and patent applications for products related to enzymatic methods, including chondroitinase, of treating CNS disorders. Under the same license, we also have non-exclusive rights to these patents and patent applications for products related to small molecule inhibitors for use in treating CNS disorders.
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We have an exclusive, worldwide license from the Mayo Foundation for Education and Research, or Mayo Clinic, to specified patents, patent applications, and other intellectual property on certain antibodies relating to our research on the therapeutic use of these antibodies, specifically myelination and remyelination in MS and SCI.
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We have an exclusive, worldwide sublicense from Paion AG (formerly CeNeS Pharmaceuticals plc) to certain patents, patent applications and know-how relating to GGF2 or fragments thereof and non-protein products developed through the use of material covered by a valid claim in the patents. The license to these patents and the right to sub-license these patents were granted to Paion by the Ludwig Institute for Cancer Research. We also have an exclusive, worldwide sublicense from Paion to certain Paion patents, patent applications, and know-how relating to the neuregulin growth factor gene NRG-2.
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We have a license from Brigham and Women’s Hospital, Inc., or Brigham, acting on its own behalf and on behalf of Beth Israel Deaconess Medical Center, or Beth Israel, to patent rights relating to the use of GGF2 in the treatment of congestive heart failure. Our rights in the U.S. are co-exclusive, with
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Brigham and Beth Israel having retained rights for internal research, clinical, and education purposes, and our rights outside the U.S are exclusive.
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We have a patent portfolio with multifaceted coverage on aminopyridine-related subject matter.
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We hold an exclusive, worldwide license from Alkermes (formerly Elan) to granted U.S. patents and the corresponding foreign patents. In March 2010 we filed a patent term extension request with the U.S. Patent and Trademark Office, or USPTO, under the Hatch Waxman law on U.S. Patent No. 5,540,938 (“the ‘938 patent” ). The claims of the ‘938 patent relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. In October 2012, the USPTO determined that the ‘938 patent is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act. With a five year patent term extension, the ‘938 patent would expire in 2018. We have also applied for Supplementary Protection Certificates or “SPCs” in various European countries based on the corresponding European Patent, which was originally set to expire in November 2011.
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Also listed in the Orange Book is U.S. Patent No. US 8,007,826 (which is owned by Acorda)with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Based on the final patent term adjustment calculation of the United States Patent and Trademark Office, or USPTO, this patent will extend into 2027.
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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 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 conditions such as cerebral palsy and post-stroke deficits;
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Obtaining FDA approval for, and commercializing, the Diazepam Nasal Spray product that we acquired from Neuronex, Inc. in December 2012;
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continuing to advance clinical development of our AC105, rHIgM22, and GGF2 programs;
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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 inlicensing 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 dispense or support Ampyra;
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reduce their efforts or discontinue dispensing or supporting Ampyra;
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not devote the resources necessary to dispense 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 or adequate product reimbursement in a timely manner, or at all, as discussed in further detail below in these risk factors;
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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
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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
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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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·
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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, 2012
|
|||
Fourth Quarter
|
$27.36
|
$22.37
|
|
Third Quarter
|
$26.65
|
$21.33
|
|
Second Quarter
|
$27.17
|
$21.04
|
|
First Quarter
|
$27.74
|
$23.99
|
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
|
12/07
|
12/08
|
12/09
|
12/10
|
12/11
|
12/12
|
||
Acorda Therapeutics, Inc
|
100.00
|
93.40
|
114.75
|
124.13
|
108.56
|
113.21
|
|
NASDAQ Composite
|
100.00
|
59.03
|
82.25
|
97.32
|
98.63
|
110.78
|
|
NASDAQ Biotechnology
|
100.00
|
93.40
|
103.19
|
113.89
|
129.12
|
163.33
|
Year Ended December 31,
|
|||||||||
2012
|
2011
|
2010
|
2009
|
2008
|
|||||
(in thousands, except per share data)
|
|||||||||
Statement of Operations Data:
|
|||||||||
Total net revenues
|
$305,814
|
$292,237
|
$191,005
|
$54,673
|
$47,827
|
||||
Costs and expenses:
|
|||||||||
Cost of sales
|
57,007
|
64,183
|
35,518
|
11,059
|
11,355
|
||||
Cost of milestone and license revenue
|
634
|
2,384
|
660
|
330
|
—
|
||||
Research and development
|
53,881
|
42,108
|
30,600
|
34,611
|
36,604
|
||||
Selling, general and administrative
|
168,690
|
148,508
|
132,657
|
89,930
|
73,307
|
||||
Total operating expenses
|
280,212
|
257,183
|
199,435
|
135,930
|
121,266
|
||||
Operating income (loss)
|
25,602
|
35,054
|
(8,430)
|
(81,257)
|
(73,439)
|
||||
Other expense:
|
|||||||||
Interest and amortization of debt discount expense
|
(1,880)
|
(3,570)
|
(3,922)
|
(4,415)
|
(5,591)
|
||||
Interest income
|
552
|
552
|
575
|
1,750
|
4,682
|
||||
Other income (expense)
|
(6)
|
(18)
|
8
|
(18)
|
8
|
||||
Total other expense
|
(1,334)
|
(3,036)
|
(3,339)
|
(2,683)
|
(901)
|
||||
Income (loss) before income taxes
|
24,268
|
32,018
|
(11,769)
|
(83,940)
|
(74,340)
|
||||
Benefit (provision) for income taxes
|
130,690
|
(1,413)
|
—
|
—
|
—
|
||||
Net income (loss)
|
$154,958
|
$30,605
|
$(11,769)
|
$(83,940)
|
$(74,340)
|
||||
Net income (loss) per share —basic
|
$3.93
|
$0.78
|
$(0.31)
|
$(2.22)
|
$(2.19)
|
||||
Net income (loss) per share —diluted
|
$3.84
|
$0.76
|
$(0.31)
|
$(2.22)
|
$(2.19)
|
||||
Weighted average shares of common stock outstanding used in computing net income (loss) per share —basic
|
39,459
|
39,000
|
38,355
|
37,735
|
33,939
|
||||
Weighted average shares of common stock outstanding used in computing net income (loss) per share —diluted
|
40,332
|
40,064
|
38,355
|
37,735
|
33,939
|
As of December 31,
|
|||||||||
2012
|
2011
|
2010
|
2009
|
2008
|
|||||
(in thousands)
|
|||||||||
Consolidated Balance Sheet Data:
|
|||||||||
Cash and cash equivalents
|
$41,876
|
$57,954
|
$34,641
|
$47,314
|
$29,613
|
||||
Investments
|
291,312
|
237,953
|
205,389
|
224,778
|
216,435
|
||||
Working capital
|
234,192
|
273,599
|
217,274
|
220,380
|
207,445
|
||||
Deferred tax asset
|
136,727
|
—
|
—
|
—
|
—
|
||||
Total assets
|
565,332
|
379,488
|
342,101
|
319,471
|
281,501
|
||||
Deferred product revenue—Zanaflex Capsules
|
29,275
|
30,599
|
31,296
|
30,704
|
24,303
|
||||
Current portion of deferred license revenue
|
9,057
|
9,057
|
9,429
|
9,429
|
—
|
||||
Non-current portion of deferred license revenue
|
68,685
|
77,742
|
86,429
|
95,857
|
—
|
||||
Current portion of revenue interest liability—PRF transaction
|
1,134
|
1,001
|
1,297
|
6,179
|
6,181
|
||||
Put/call option liability—PRF transaction
|
329
|
1,030
|
391
|
638
|
338
|
||||
Non-current portion of revenue interest liability—PRF transaction
|
1,111
|
1,898
|
3,586
|
5,631
|
12,498
|
||||
Long term convertible notes payable
|
4,244
|
5,230
|
6,186
|
7,112
|
6,905
|
||||
Total stockholders’ equity
|
385,921
|
205,209
|
151,261
|
137,333
|
207,157
|
|
|
|
·
|
The first is U.S. Patent No. US 8,007,826 with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Based on the final patent term adjustment calculation of the United States Patent and Trademark Office, or USPTO, this patent will extend into 2027.
|
|
·
|
The second is U.S. Patent No. 5,540,938 (“the ‘938 patent”), the claims of which relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. In October 2012, the USPTO determined that the ‘938 patent is entitled to a full five year patent term extension under the patent restoration provisions of the Hatch Waxman Act. With a five year patent term extension, the ‘938 patent would expire in 2018.
We have an exclusive license to this patent from Alkermes (originally with Elan, but transferred to Alkermes as part of its acquisition of Elan’s Drug Technologies business).
|
|
·
|
We expect 2013 net revenue from the sale of Ampyra to range from $285 million to $315 million.
|
|
·
|
We expect Zanaflex (tizanidine hydrochloride) and ex-U.S. Fampyra 2013 revenue to be $25 million, which includes sales of branded Zanaflex products, royalties from ex-U.S. Fampyra and authorized generic tizanidine hydrochloride capsules sales, and $9.1 million in amortized licensing revenue from the $110 million payment we received from Biogen Idec in 2009 for Fampyra ex-U.S. development and commercialization rights.
|
|
·
|
Research and development expenses in 2013 are expected to range from $60 million to $70 million, excluding share-based compensation charges. Research and development expenses in 2013 related to Ampyra include proof-of-concept studies in CP and post-stroke deficits, and sponsorship of investigator-initiated studies. Additional expenses include clinical trials for AC105 and rHIgM22, continued development of Diazepam Nasal Spray and GGF2, as well as ongoing preclinical studies. A substantial portion of the increase in research and development in 2013 over 2012 is related to Diazepam Nasal Spray expenses.
|
|
·
|
Selling, general and administrative expenses in 2013 are expected to range from $170 million to $180 million, excluding share-based compensation charges. SG&A expenses will be primarily driven by commercial and administrative costs related to Ampyra. The majority of the increase in SG&A in 2013 over 2012 is related to Diazapam Nasal Spray expenses.
|
|
·
|
We expect to be cash flow positive in 2013.
|
|
·
|
Pending additional clinical and manufacturing data, we plan to submit a 505(b)(2)-type New Drug Application for Diazepam Nasal Spray to the FDA in 2013, with potential FDA approval and commercial launch in 2014. We anticipate that our current infrastructure can support sales and marketing of this product, and market planning is underway.
|
|
·
|
We completed enrollment for the second phase of our Phase 2 proof-of-concept clinical trial of dalfampridine in adults with CP. This phase is a multi-dose study including 20 adults with CP, to evaluate both safety and efficacy. We expect to announce topline results of this phase of the study in the second quarter of 2013.
|
|
·
|
We have an open IND for rHIgM22 for the treatment of MS and plan to initiate enrollment in a Phase 1 safety study in MS patients in the first half of 2013.
|
|
·
|
We have completed analysis of the three-month data from our Phase 1 clinical trial of GGF2 in heart failure patients, and we plan to present findings in a platform presentation at the American College of Cardiology (ACC) annual meeting in March 2013.
|
|
·
|
A Phase 2 proof-of-concept clinical trial of dalfampridine in patients with post stroke deficits began in the second quarter of 2012. We expect to announce topline study results in the second quarter of 2013.
|
|
·
|
We submitted a Phase 2 clinical trial protocol for AC105 for acute treatment of SCI to the FDA for review. The protocol has been reviewed by the FDA, and we are preparing to initiate the trial in the first half of 2013.
|
|
·
|
Funding of investigator-initiated studies of Ampyra in MS, focused on a range of functional deficits in MS and other neurological disorders, will be ongoing in 2013.
|
·
|
The Company is no longer in a three-year cumulative pre-tax loss position. According to the guidance this is a significant factor to weigh heavily when looking at positive and negative evidence.
|
·
|
We achieved our second consecutive profitable year with a 2012 pre-tax income of $24.3 million.
|
·
|
Our Ampyra U.S. Patent No. US 8,007,826
patent extends into 2027.
|
·
|
Our projections show that the deferred tax assets for our net operating loss carryforwards and research and development tax credits will be realized prior to their expiration.
|
·
|
There is an inherent risk in the ability to meet budgeted forecasts.
|
·
|
If we were to experience a future 382 ownership change, the ability to utilize net operating losses may be limited, depending on the market value of the company at the time of any such ownership change.
|
·
|
We may acquire other compounds in the future, which may generate losses.
|
|
•
|
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)
|
21,991
|
3,443
|
10,853
|
7,695
|
|||
Inventory purchase commitments (4)
|
22,219
|
22,219
|
—
|
—
|
|||
Total
|
$49,931
|
$26,806
|
$14,286
|
$8,839
|
(1)
|
Excludes PRF principal and interest payments, due to uncertainty as to the amount and timing of such payments.
|
(2)
|
Represents the remaining 5 annual payments of principal and interest to be made on the convertible note payable to Saints Capital.
|
(3)
|
Represents payments for new lease for Ardsley, NY lease.
|
(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, 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
|
Allowances for sales 2012
|
14,609
|
3,126
|
5,073
|
3,265
|
-
|
3,481
|
29,554
|
Allowances for prior year sales
|
72
|
(10)
|
(86)
|
(71)
|
(452)
|
(17)
|
(564)
|
Actual credits for sales during 2012
|
(11,651)
|
(2,386)
|
(4,851)
|
(2,967)
|
(18)
|
(2,688)
|
(24,561)
|
Actual credits for prior year sales
|
(3,280)
|
(263)
|
(49)
|
(237)
|
-
|
(982)
|
(4,811)
|
Balance at December 31, 2012
|
$2,849
|
$740
|
$222
|
$293
|
$10
|
$792
|
$4,906
|
|
|
|
·
|
salaries and related benefits and share-based compensation for research and development personnel;
|
|
|
|
·
|
costs of facilities and equipment that have no alternative future use;
|
|
|
|
·
|
fees paid to professional service providers in conjunction with independently monitoring our clinical trials and acquiring and evaluating data in conjunction with our clinical trials;
|
|
|
|
·
|
fees paid to contract research organizations (CROs) in conjunction with preclinical studies;
|
|
|
|
·
|
fees paid to organizations in conjunction with contract manufacturing;
|
|
|
|
·
|
costs of materials used in research and development;
|
|
|
|
·
|
upfront and milestone payments under contractual agreements;
|
|
|
|
·
|
consulting, license and sponsored research fees paid to third parties; and
|
|
|
|
·
|
depreciation of capital resources used to develop our products.
|
(in thousands)
|
Year Ended December 31,
|
||
2012
|
2011
|
2010
|
|
Preclinical and clinical development:
|
|||
Contract expenses—Ampyra (1)
|
$12,840
|
$11,429
|
$6,873
|
Contract expenses—Diazepam Nasal Spray
|
843
|
-
|
-
|
Contract expenses—GGF2
|
6,182
|
4,610
|
1,123
|
Contract expenses—rHIgM22
|
1,219
|
3,608
|
5,288
|
Contract expenses—AC105
|
1,197
|
132
|
-
|
Contract expenses—Chondroitinase
|
498
|
118
|
150
|
Research and development operating expenses:
|
23,929
|
19,211
|
16,041
|
Acquisitions, licenses and milestones:
|
|||
Diazepam nasal spray
|
6,653
|
-
|
-
|
GGF2
|
-
|
-
|
1,125
|
AC105
|
500
|
3,000
|
-
|
Other
|
20
|
-
|
-
|
Total research and development
|
$53,881
|
$42,108
|
$30,600
|
|
•
|
The Company is no longer in a three-year cumulative pre-tax loss position. According to the guidance this is a significant factor to weigh heavily when looking at positive and negative evidence.
|
|
•
|
We achieved our second consecutive profitable year with a 2012 pre-tax income of $24.3 million.
|
|
•
|
Our Ampyra U.S. Patent No. US 8,007,826 patent extends into 2027.
|
|
•
|
Our projections show that the deferred tax assets for our net operating loss carryforwards and research and development tax credits will be realized prior to their expiration.
|
|
•
|
There is an inherent risk in the ability to meet budgeted forecasts.
|
|
•
|
If we were to experience a future 382 ownership change, the ability to utilize net operating losses may be limited, depending on the market value of the company at the time of any such ownership change.
|
|
•
|
We may acquire other compounds in the future, which may generate losses.
|
Assumption
|
Method of estimating
|
||||||
●
|
Estimated expected term of options
|
●
|
Historical term of our options based on exercise data
|
||||
●
|
Expected volatility
|
●
|
Historic volatility of our common stock
|
||||
●
|
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:
|
Financial Statements of Acorda Therapeutics, Inc. and Subsidiaries:
|
|
Report of Ernst and Young LLP, Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets as of December 31, 2012 and 2011
|
|
Consolidated Statements of Operations for the years ended December 31, 2012, 2011 and 2010
|
|
Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, 2012, 2011 and 2010
|
|
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2012, 2011 and 2010
|
|
Consolidated Statements of Cash Flows for the years ended December 31, 2012, 2011 and 2010
|
|
Notes to Financial Statements
|
PAGE
|
|
Consolidated Financial Statements of Acorda Therapeutics, Inc. and Subsidiaries:
|
|
Report of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated Balance Sheets
|
F-3
|
Consolidated Statements of Operations
|
F-4
|
Consolidated Statements of Comprehensive Income (Loss)
|
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,
|
||||||||
2012
|
2011
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 41,876 | $ | 57,954 | ||||
Restricted cash
|
380 | 303 | ||||||
Short-term investments
|
191,949 | 237,953 | ||||||
Trade accounts receivable, net of allowances of $555 and $879, as of December 31, 2012 and 2011, respectively
|
26,327 | 22,828 | ||||||
Prepaid expenses
|
6,936 | 6,534 | ||||||
Finished goods inventory held by the Company
|
20,176 | 27,256 | ||||||
Finished goods inventory held by others
|
781 | 1,126 | ||||||
Deferred tax asset
|
35,091 | — | ||||||
Other current assets
|
9,547 | 6,988 | ||||||
Total current assets
|
333,063 | 360,942 | ||||||
Long-term investments
|
99,363 | — | ||||||
Property and equipment, net of accumulated depreciation
|
16,706 | 3,858 | ||||||
Deferred tax asset
|
101,636 | — | ||||||
Intangible assets, net of accumulated amortization
|
9,319 | 8,769 | ||||||
Non-current portion of deferred cost of license revenue
|
4,808 | 5,442 | ||||||
Other assets
|
437 | 477 | ||||||
Total assets
|
$ | 565,332 | $ | 379,488 | ||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 22,503 | $ | 21,393 | ||||
Accrued expenses and other current liabilities
|
35,758 | 24,149 | ||||||
Deferred product revenue—Zanaflex
|
29,275 | 30,599 | ||||||
Current portion of deferred license revenue
|
9,057 | 9,057 | ||||||
Current portion of revenue interest liability
|
1,134 | 1,001 | ||||||
Current portion of convertible notes payable
|
1,144 | 1,144 | ||||||
Total current liabilities
|
98,871 | 87,343 | ||||||
Non-current portion of deferred license revenue
|
68,685 | 77,742 | ||||||
Put/call liability
|
329 | 1,030 | ||||||
Non-current portion of revenue interest liability
|
1,111 | 1,898 | ||||||
Non-current portion of convertible notes payable
|
4,244 | 5,230 | ||||||
Other non-current liabilities
|
6,171 | 1,036 | ||||||
Commitments and contingencies
|
||||||||
Stockholders’ equity:
|
||||||||
Common stock, $0.001 par value. Authorized 80,000,000 shares at December 31, 2012 and 2011; issued and outstanding 39,804,493 and 39,328,495 shares, including those held in treasury, as of December 31, 2012 and 2011, respectively
|
40 | 39 | ||||||
Treasury stock
at cost (12,420 shares at December 31, 2012 and December 31, 2011)
|
(329 | ) | (329 | ) | ||||
Additional paid-in capital
|
640,671 | 614,914 | ||||||
Accumulated deficit
|
(254,523 | ) | (409,481 | ) | ||||
Accumulated other comprehensive income
|
62 | 66 | ||||||
Total stockholders’ equity
|
385,921 | 205,209 | ||||||
Total liabilities and stockholders’ equity
|
$ | 565,332 | $ | 379,488 |
Year ended December 31,
|
Year ended December 31,
|
Year ended December 31,
|
||||||||||
2012
|
2011
|
2010
|
||||||||||
Revenues:
|
||||||||||||
Net product revenues
|
$ | 282,381 | $ | 256,271 | $ | 181,545 | ||||||
Milestone revenue
|
— | 25,000 | — | |||||||||
License revenue
|
9,057 | 9,057 | 9,428 | |||||||||
Royalty revenues
|
14,376 | 1,909 | 32 | |||||||||
Total net revenues
|
305,814 | 292,237 | 191,005 | |||||||||
Costs and expenses:
|
||||||||||||
Cost of sales
|
57,007 | 64,183 | 35,518 | |||||||||
Cost of milestone and license revenue
|
634 | 2,384 | 660 | |||||||||
Research and development
|
53,881 | 42,108 | 30,600 | |||||||||
Selling, general and administrative
|
168,690 | 148,508 | 132,657 | |||||||||
Total operating expenses
|
280,212 | 257,183 | 199,435 | |||||||||
Operating income (loss)
|
25,602 | 35,054 | (8,430 | ) | ||||||||
Other expense (net):
|
||||||||||||
Interest and amortization of debt discount expense
|
(1,880 | ) | (3,570 | ) | (3,922 | ) | ||||||
Interest income
|
552 | 552 | 575 | |||||||||
Other income (expense)
|
(6 | ) | (18 | ) | 8 | |||||||
Total other expense (net)
|
(1,334 | ) | (3,036 | ) | (3,339 | ) | ||||||
Income (loss) before taxes
|
24,268 | 32,018 | (11,769 | ) | ||||||||
Benefit from (provision for) income taxes
|
130,690 | (1,413 | ) | — | ||||||||
Net income (loss)
|
$ | 154,958 | $ | 30,605 | $ | (11,769 | ) | |||||
Net income (loss) per share—basic
|
$ | 3.93 | $ | 0.78 | $ | (0.31 | ) | |||||
Net income (loss) per share—diluted
|
$ | 3.84 | $ | 0.76 | $ | (0.31 | ) | |||||
Weighted average common shares outstanding used in computing net income (loss) per share—basic
|
39,459 | 39,000 | 38,355 | |||||||||
Weighted average common shares outstanding used in computing net income (loss) per share—diluted
|
40,332 | 40,064 | 38,355 |
Year ended December 31,
|
Year ended December 31,
|
Year ended December 31,
|
||||||||||
2012
|
2011
|
2010
|
||||||||||
Net income (loss)
|
$ | 154,958 | $ | 30,605 | $ | (11,769 | ) | |||||
Other comprehensive income (loss):
|
||||||||||||
Unrealized gains (losses) on available for sale securities, net of tax
|
(4 | ) | 78 | (121 | ) | |||||||
Other comprehensive income (loss), net of tax
|
(4 | ) | 78 | (121 | ) | |||||||
Comprehensive income (loss)
|
$ | 154,954 | $ | 30,683 | $ | (11,890 | ) |
Common stock
|
||||||||||||||||||||||||||||
Number
of
shares
|
Par
value
|
Treasury stock
|
Additional
paid-in
capital
|
Accumulated
deficit
|
Accumulated
other
comprehensive
income (loss)
|
Total
stockholders’
equity
|
||||||||||||||||||||||
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 | |||||||||||||||||||||
Other comprehensive loss
|
— | — | — | — | — | (121 | ) | (121 | ) | |||||||||||||||||||
Net loss
|
— | — | — | — | (11,769 | ) | — | (11,769 | ) | |||||||||||||||||||
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 | |||||||||||||||||||||
Other comprehensive income
|
— | — | — | — | — | 78 | 78 | |||||||||||||||||||||
Net income
|
— | — | — | — | 30,605 | — | 30,605 | |||||||||||||||||||||
Balance at December 31, 2011
|
39,328 | $ | 39 | $ | (329 | ) | $ | 614,914 | $ | (409,481 | ) | $ | 66 | $ | 205,209 | |||||||||||||
Compensation expense for issuance of stock options to employees
|
— | — | — | 15,206 | — | — | 15,206 | |||||||||||||||||||||
Compensation expense for issuance of restricted stock to employees
|
224 | — | — | 6,212 | — | — | 6,212 | |||||||||||||||||||||
Exercise of stock options
|
252 | 1 | — | 4,339 | — | — | 4,340 | |||||||||||||||||||||
Other comprehensive loss, net of tax
|
— | — | — | — | — | (4 | ) | (4 | ) | |||||||||||||||||||
Net income
|
— | — | — | — | 154,958 | — | 154,958 | |||||||||||||||||||||
Balance at December 31, 2012
|
39,804 | $ | 40 | $ | (329 | ) | $ | 640,671 | $ | (254,523 | ) | $ | 62 | $ | 385,921 |
Year ended
December 31,
|
Year ended
December 31,
|
Year ended
December 31
|
||||||||||
2012
|
2011
|
2010
|
||||||||||
Cash flows from operating activities:
|
||||||||||||
Net income (loss)
|
$ | 154,958 | $ | 30,605 | $ | (11,769 | ) | |||||
Adjustments to reconcile net loss to net cash provided by/(used in) operating activities:
|
||||||||||||
Share-based compensation expense
|
21,418 | 19,303 | 17,777 | |||||||||
Amortization of net premiums and discounts on investments
|
4,382 | 6,750 | 4,473 | |||||||||
Amortization of revenue interest issuance cost
|
67 | 104 | 96 | |||||||||
Depreciation and amortization expense
|
4,663 | 4,625 | 3,951 | |||||||||
Intangible asset impairment
|
664 | 13,038 | — | |||||||||
(Gain) loss on put/call liability
|
(701 | ) | 639 | (246 | ) | |||||||
Deferred tax benefit
|
(133,042 | ) | — | — | ||||||||
Changes in assets and liabilities:
|
||||||||||||
Increase in accounts receivable
|
(3,499 | ) | (556 | ) | (16,533 | ) | ||||||
Increase in prepaid expenses and other current assets
|
(2,961 | ) | (3,375 | ) | (1,892 | ) | ||||||
Decrease (increase) in inventory held by the Company
|
7,082 | 8,976 | (31,735 | ) | ||||||||
Decrease in inventory held by others
|
345 | 1,060 | 209 | |||||||||
Decrease in non-current portion of deferred cost of license revenue
|
634 | 608 | 660 | |||||||||
(Decrease) increase in other assets
|
(3,753 | ) | (237 | ) | 1 | |||||||
(Decrease) increase in accounts payable, accrued expenses, other current liabilities
|
11,743 | (6,108 | ) | 24,706 | ||||||||
(Decrease) increase in revenue interest liability interest payable
|
600 | (23 | ) | (76 | ) | |||||||
Decrease in current portion of deferred license revenue
|
— | (371 | ) | — | ||||||||
Decrease in non-current portion of deferred license revenue
|
(9,057 | ) | (8,686 | ) | (9,428 | ) | ||||||
(Decrease) Increase in other non-current liabilities
|
(22 | ) | 682 | — | ||||||||
(Decrease) increase in deferred product revenue—Zanaflex
|
(1,325 | ) | (697 | ) | 592 | |||||||
Restricted cash
|
(77 | ) | (1 | ) | (1 | ) | ||||||
Net cash (used in)/provided by operating activities
|
52,119 | 66,336 | (19,215 | ) | ||||||||
Cash flows from investing activities:
|
||||||||||||
Purchases of property and equipment
|
(10,384 | ) | (2,192 | ) | (2,446 | ) | ||||||
Purchases of intangible assets
|
(3,194 | ) | (3,595 | ) | (6,998 | ) | ||||||
Purchases of investments
|
(322,455 | ) | (266,736 | ) | (310,955 | ) | ||||||
Proceeds from maturities of investments
|
264,750 | 227,500 | 325,750 | |||||||||
Net cash (used in)/provided by investing activities
|
(71,283 | ) | (45,023 | ) | 5,351 | |||||||
Cash flows from financing activities:
|
||||||||||||
Proceeds from stock option exercises
|
4,339 | 3,962 | 8,370 | |||||||||
Purchase of treasury stock
|
— | — | (329 | ) | ||||||||
Repayments of revenue interest liability
|
(1,253 | ) | (1,962 | ) | (6,850 | ) | ||||||
Net cash provided by financing activities
|
3,086 | 2,000 | 1,191 | |||||||||
Net increase (decrease) in cash and cash equivalents
|
(16,078 | ) | 23,313 | (12,673 | ) | |||||||
Cash and cash equivalents at beginning of period
|
57,954 | 34,641 | 47,314 | |||||||||
Cash and cash equivalents at end of period
|
$ | 41,876 | $ | 57,954 | $ | 34,641 | ||||||
Supplemental disclosure:
|
||||||||||||
Cash paid for interest
|
$ | 1,122 | $ | 3,404 | $ | 3,781 | ||||||
Cash paid for taxes
|
2,706 | 1,176 | — |
|
(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, 2012
|
||||||||||||||||
US Treasury bonds
|
$ | 291,209 | $ | 104 | $ | (1 | ) | $ | 291,312 | |||||||
December 31, 2011
|
||||||||||||||||
US Treasury bonds
|
$ | 237,887 | $ | 72 | $ | (6 | ) | $ | 237,953 |
(In thousands)
|
December 31,
2012
|
December 31,
2011
|
Estimated
useful lives used
|
||||||
Leasehold improvements
|
$ | 10,167 | $ | 3,240 |
Remaining lease term
|
||||
Computer equipment
|
8,651 | 5,859 |
2-3 years
|
||||||
Laboratory equipment
|
3,562 | 2,534 |
5 years
|
||||||
Furniture and fixtures
|
1,645 | 760 |
7 years
|
||||||
Capital in progress
|
1,810 | 1,093 |
2-3 years
|
||||||
25,835 | 13,486 | ||||||||
Less accumulated depreciation
|
(9,129 | ) | (9,628 | ) | |||||
$ | 16,706 | $ | 3,858 |
(In thousands)
|
December 31,
2012
|
December 31,
2011
|
||||||
Accrued inventory
|
$ | 9,222 | $ | 2,464 | ||||
Bonus payable
|
6,361 | 4,725 | ||||||
Ampyra and Zanaflex discount and allowances accruals
|
4,603 | 4,680 | ||||||
Commercial and marketing expense accruals
|
3,367 | 1,811 | ||||||
Research and development expense accruals
|
2,182 | 640 | ||||||
Sales force commissions and incentive payments payable
|
1,820 | 1,893 | ||||||
Royalties payable
|
1,680 | 1,977 | ||||||
Ampyra milestone
|
— | 2,500 | ||||||
Other accrued expenses
|
6,523 | 3,459 | ||||||
$ | 35,758 | $ | 24,149 |
Year ended December 31,
|
|||||
2012
|
2011
|
2010
|
|||
Employees and directors:
|
|||||
Estimated volatility
|
60.67%
|
62.80%
|
66.31%
|
||
Expected life in years
|
5.64
|
5.47
|
5.50
|
||
Risk free interest rate
|
1.16%
|
2.23%
|
2.57%
|
||
Dividend yield
|
—
|
—
|
—
|
Year ended December 31,
|
||||||||||||
(In thousands)
|
2012
|
2011
|
2010
|
|||||||||
Research and development
|
$ | 5,122 | $ | 5,801 | $ | 5,247 | ||||||
Selling, general and administrative
|
16,296 | 13,502 | 12,530 | |||||||||
Total
|
$ | 21,418 | $ | 19,303 | $ | 17,777 |
Number
of Shares (In thousands)
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining
Contractual Term
|
Intrinsic
Value (In thousands)
|
|||||||
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 | ||||||||
Granted
|
1,292 | 25.69 | ||||||||
Forfeited and expired
|
(166 | ) | 27.98 | |||||||
Exercised
|
(252 | ) | 17.24 | |||||||
Balance at December 31, 2012
|
5,667 | $ | 22.30 |
6.6
|
$24,937
|
|||||
Vested and expected to vest at December 31, 2012
|
5,609 | $ | 22.27 |
6.6
|
$24,892
|
|||||
Vested and exercisable at December 31, 2012
|
3,639 | $ | 20.35 |
5.5
|
$22,925
|
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||||||
Range of exercise price
|
Outstanding
as of
December 31,
2012 (In thousands)
|
Weighted-
average
remaining
contractual life
|
Weighted-
average
exercise price
|
Exercisable
as of
December 31,
2012 (In thousands)
|
Weighted-
average
exercise price
|
|||||||||||||||||
$ | 2.45-$16.88 | 989 | 2.38 | $ | 7.35 | 989 | $ | 7.35 | ||||||||||||||
$ | 17.52-$21.97 | 917 | 5.97 | 20.25 | 810 | 20.14 | ||||||||||||||||
$ | 22.00-$24.39 | 1,352 | 7.48 | 22.35 | 704 | 22.33 | ||||||||||||||||
$ | 24.51-$29.92 | 1,433 | 8.64 | 26.55 | 453 | 26.96 | ||||||||||||||||
$ | 30.12-$37.48 | 976 | 7.38 | 33.05 | 683 | 5.23 | ||||||||||||||||
5,667 | 6.62 | $ | 22.30 | 3,639 | $ | 20.35 |
Restricted Stock
|
Number of Shares (In thousands)
|
|
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
|
|
Granted
|
320
|
|
Vested
|
(224)
|
|
Forfeited
|
(15)
|
|
Nonvested at December 31, 2012
|
458
|
(In thousands, except per share data)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
|||||||||
Basic and diluted
|
||||||||||||
Net income (loss)
|
$ | 154,958 | $ | 30,605 | $ | (11,769 | ) | |||||
Weighted average common shares outstanding used in computing net income (loss) per share—basic
|
39,459 | 39,000 | 38,355 | |||||||||
Plus: net effect of dilutive stock options and restricted common shares
|
873 | 1,064 | — | |||||||||
Weighted average common shares outstanding used in computing net income (loss) per share—diluted
|
40,332 | 40,064 | 38,355 | |||||||||
Net income (loss) per share—basic
|
$ | 3.93 | $ | 0.78 | $ | (0.31 | ) | |||||
Net income (loss) per share—diluted
|
$ | 3.84 | $ | 0.76 | $ | (0.31 | ) |
(In thousands)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
||
Denominator
|
|||||
Stock options and restricted common shares
|
5,252
|
4,106
|
4,408
|
||
Convertible note
|
48
|
58
|
67
|
(In thousands)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
|||||||||
Income (loss) before taxes
|
$ | 24,268 | $ | 32,018 | $ | (11,769 | ) |
(In thousands)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
|||||||||
Current:
|
||||||||||||
Federal
|
$ | (640 | ) | $ | (912 | ) | $ | — | ||||
State
|
(1,138 | ) | (501 | ) | — | |||||||
Foreign
|
(574 | ) | — | — | ||||||||
(2,352 | ) | (1,413 | ) | — | ||||||||
Deferred:
|
||||||||||||
Federal
|
119,247 | — | — | |||||||||
State
|
13,795 | — | — | |||||||||
Foreign
|
— | — | — | |||||||||
133,042 | — | — | ||||||||||
Total benefit from/(provision for) income taxes
|
$ | 130,690 | $ | (1,413 | ) | $ | — |
(In thousands)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
||
U.S. federal statutory tax rate
|
35.0%
|
35.0%
|
35.0%
|
||
State and local income taxes
|
2.4%
|
1.0%
|
—
|
||
Foreign income tax
|
1.5%
|
—
|
—
|
||
Stock option compensation
|
1.9%
|
1.2%
|
—
|
||
Stock option shortfall
|
5.6%
|
—
|
—
|
||
Neuronex acquisition
|
9.4%
|
—
|
—
|
||
Other nondeductible and permanent differences
|
3.3%
|
(12.4%
|
) |
—
|
|
Provision (benefit) attributable to valuation allowance
|
(597.6%)
|
(20.4%)
|
(35%)
|
||
Effective income tax rate
|
(538.5%)
|
4.4%
|
—
|
(In thousands)
|
December 31,
2012
|
December 31,
2011
|
||||||
Deferred tax assets:
|
||||||||
Net operating loss carryforwards
|
$ | 64,121 | $ | 75,717 | ||||
Tax credits
|
4,568 | 4,025 | ||||||
Deferred revenue
|
36,646 | 38,958 | ||||||
Stock based compensation
|
17,849 | 13,910 | ||||||
Other
|
14,756 | 15,518 | ||||||
Total deferred tax assets
|
137,940 | 148,128 | ||||||
Valuation allowance
|
— | (147,596 | ) | |||||
Total deferred tax assets net of valuation allowance
|
137,940 | 532 | ||||||
Deferred tax liabilities:
|
||||||||
Property, plant and equipment
|
(1,213 | ) | (532 | ) | ||||
Total deferred tax liabilities
|
(1,213 | ) | (532 | ) | ||||
Net deferred tax asset
|
$ | 136,727 | $ | — |
(In thousands)
|
December 31,
2012
|
December 31,
2011
|
||||||
Current deferred tax assets, net:
|
||||||||
Current deferred tax assets, net of deferred tax liabilities
|
$ | 35,091 | $ | 30,310 | ||||
Valuation allowance
|
— | (30,310 | ) | |||||
Current deferred tax assets, net
|
35,091 | — | ||||||
Non-current deferred tax assets, net:
|
||||||||
Non-current deferred tax assets, net of deferred tax liabilities
|
101,636 | 117,286 | ||||||
Valuation allowance
|
— | (117,286 | ) | |||||
Non-current deferred tax assets, net
|
101,636 | — | ||||||
Net deferred tax asset
|
$ | 136,727 | $ | — |
(In thousands)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
Year ended
December 31,
2010
|
|||||||||
Beginning of period balance
|
$ | — | $ | — | $ | — | ||||||
Increases for tax positions taken during a prior period
|
1,936 | — | — | |||||||||
Decreases for tax positions taken during a prior period
|
— | — | — | |||||||||
Increases for tax positions taken during the current period
|
— | — | — | |||||||||
Reduction as a result of a lapse of statute of limitations
|
— | — | — | |||||||||
$ | 1,936 | $ | — | $ | — |
(In thousands)
|
|
2013
|
$3,443
|
2014
|
3,529
|
2015
|
3,617
|
2016
|
3,707
|
2017
|
3,800
|
Later years
|
22,194
|
$40,290
|
(In thousands)
|
December 31,
2012
|
December 31,
2011
|
Estimated
remaining
useful lives as of
December 31,
2012
|
||
Zanaflex Capsule patents
|
$19,350
|
$19,350
|
0 years
|
||
Zanaflex trade name
|
2,150
|
2,150
|
0 years
|
||
Ampyra milestones
|
5,750
|
5,750
|
14 years
|
||
Ampyra CSRO royalty buyout
|
3,000
|
3,000
|
7 years
|
||
Website development costs
|
5,841
|
4,028
|
3 years
|
||
Website development costs – in process
|
712
|
42
|
3 years
|
||
36,803
|
34,320
|
||||
Less accumulated amortization
|
27,484
|
25,551
|
|||
$9,319
|
$8,769
|
(In thousands)
|
|
2013
|
$1,826
|
2014
|
1,573
|
2015
|
1,368
|
2016
|
588
|
2017
|
588
|
$5,943
|
|
•
|
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
|
|||
2012
|
||||||
Assets Carried at Fair Value:
|
||||||
Cash equivalents
|
$27,932
|
$—
|
$—
|
|||
Short-term investments
|
—
|
191,949
|
—
|
|||
Long-term investments
|
—
|
99,363
|
—
|
|||
Liabilities Carried at Fair Value:
|
||||||
Put/call liability
|
—
|
—
|
329
|
|||
2011
|
||||||
Assets Carried at Fair Value:
|
||||||
Cash equivalents
|
$38,340
|
$—
|
$—
|
|||
Short-term investments
|
—
|
237,953
|
—
|
|||
Long-term investments
|
—
|
—
|
—
|
|||
Liabilities Carried at Fair Value:
|
||||||
Put/call liability
|
—
|
—
|
1,030
|
(In thousands)
|
Year ended
December 31,
2012
|
Year ended
December 31,
2011
|
||
Put/call liability:
|
||||
Balance, beginning of period
|
$1,030
|
$391
|
||
Total realized and unrealized (gains) losses included in selling, general and administrative expenses:
|
(701)
|
639
|
||
Balance, end of period
|
$329
|
$1,030
|
(in thousands)
|
Net Carrying Value as of
|
Fair Value Measured and Recorded Using
|
Impairment Losses
|
||||||
December 31,
|
December 31,
|
||||||||
2012
|
Level 1
|
Level 2
|
Level 3
|
2012
|
|||||
Websites
|
$2,292
|
$2,292
|
$—
|
$—
|
$664
|
||||
Total impairment losses
|
$664
|
(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)
|
2012
|
||||||
March 31
|
June 30
|
September 30
|
December 31
|
||||
Total net revenues
|
$71,248
|
$75,656
|
$77,437
|
$81,473
|
|||
Gross profit
|
58,625
|
61,922
|
62,517
|
65,109
|
|||
Net income —basic and diluted
|
7,846
|
4,545
|
9,594
|
132,973
|
|||
Net income per share—basic
|
$0.20
|
$0.12
|
$0.24
|
$3.36
|
|||
Net income per share—diluted
|
0.19
|
0.11
|
0.24
|
3.27
|
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
|
Exhibit No.
|
Description
|
|
2.1*
|
Agreement and Plan of Merger, dated as of February 15, 2012, among the Registrant, ATI Development Corp., Neuronex, Inc., and Moise A. Khayrallah, Ph.D., solely as the Stockholders’ Representative as set forth therein. Incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2012.
|
|
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. Incorporated herein by reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
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**
|
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.
|
|
10.7**
|
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**
|
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.
|
Exhibit No.
|
Description
|
10.10**
|
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.
|
|
10.11**
|
Amendment to August 11, 2002 Employment Agreement dated June 21, 2011, by and between the Registrant and Ron Cohen. Incorporated herein by reference to Exhibit 10.61 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.12**
|
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.
|
|
10.13**
|
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.
|
|
10.14**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and Andrew R. Blight. Incorporated herein by reference to Exhibit 10.67 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.15**
|
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.
|
|
10.16**
|
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.
|
|
10.17**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and David Lawrence. Incorporated herein by reference to Exhibit 10.68 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.18**
|
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.
|
|
10.19**
|
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.
|
|
10.20**
|
Amendment to December 19, 2005 Employment Agreement, dated November 7, 2011, by and between the Registrant and Jane Wasman. Incorporated herein by reference to Exhibit 10.69 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.21**
|
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.
|
|
10.22**
|
Consulting Agreement effective as of October 1, 2011, by and between the Registrant and Thomas C. Wessel. Incorporated herein by reference to Exhibit 10.65 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.23**
|
Separation Agreement and General Release dated November 21, 2011, by and between the Registrant and Thomas C. Wessel. Incorporated herein by reference to Exhibit 10.71 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
Exhibit No.
|
Description
|
10.24**
|
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.
|
|
10.25**
|
Letter agreement dated November 7, 2011, by and between the Registrant and Lauren Sabella. Incorporated herein by reference to Exhibit 10.70 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.26**
|
Employment Offer Letter, dated August 18, 2011, by and between the Registrant and Enrique Carrazana. Incorporated herein by reference to Exhibit 10.64 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.27**
|
Letter agreement dated October 19, 2011, by and between the Registrant and Enrique Carrazana. Incorporated herein by reference to Exhibit 10.66 to the Registrant’s Annual Report on Form 10-K filed on February 28, 2012.
|
|
10.28**
|
Letter agreement dated September 4, 2012, by and between the Registrant and Enrique Carrazana. Incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed November 8, 2012.
|
|
10.29
|
Lease, dated as of June 23, 2011, by and between the Registrant and BMR-Ardsley Park LLC. Incorporated herein by reference to Exhibit 10.62 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.30
|
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.
|
|
10.31
|
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.
|
|
10.32
|
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.
|
|
10.33
|
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.
|
|
10.34
|
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.
|
|
10.35*
|
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.
|
|
10.36
|
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.
|
|
10.37*
|
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.
|
Exhibit No.
|
Description
|
10.38*
|
Amendment #1 to the License Agreement, dated March 15, 2012, by and between the Registrant and Paion Holdings UK Ltd (formerly CeNeS Pharmaceuticals, plc).
Incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2012.
|
|
10.39
|
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.
|
|
10.40*
|
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.
|
|
10.41
|
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.
|
|
10.42*
|
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.
|
|
10.43*
|
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.
|
|
10.44
|
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.
|
|
10.45
|
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.
|
|
10.46
|
Amendment No. 2 to Amended and Restated License Agreement and Supply Agreement between the Registrant and Alkermes Pharma Ireland Limited dated March 29, 2012.
|
|
10.47*
|
Development and Supplemental Agreement between Elan Pharma International Limited and the Registrant dated January 14, 2011. Incorporated herein by reference to Exhibit 10.59 to Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2011.
|
|
10.48*
|
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.
|
|
10.49*
|
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.
|
|
10.50*
|
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.
|
|
10.51
|
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.
|
Exhibit No.
|
Description
|
10.52*
|
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.
|
|
10.53*
|
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.
|
|
10.54*
|
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.
|
|
10.55*
|
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.
|
|
10.56
|
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.
|
|
10.57
|
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.
|
|
10.58
|
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.
|
|
10.59
|
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.
|
|
10.60
|
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.
|
|
10.61*
|
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.
|
|
10.62
|
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.
|
|
10.63*
|
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 herein by reference to Exhibit 10.60 to Registrant’s Quarterly Report on Form 10-Q filed on May 9, 2011.
|
|
10.64*
|
License Agreement, dated as of June 27, 2011, by and between the Registrant and Medtronic, Inc. and Warsaw Orthopedic, Inc. Incorporated herein by reference to Exhibit 10.63 to the Registrant’s Quarterly Report on Form 10-Q filed on August 8, 2011.
|
|
10.65*
|
License Agreement dated as of July 6, 2010, between SK Biopharmaceuticals Co., Ltd. (formerly SK Holdings Co., Ltd.) and Neuronex, Inc.
|
Exhibit No.
|
Description
|
21
|
List of Subsidiaries of the Registrant.
|
|
23
|
Consent of Ernst & Young 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
|
*
|
Portions of this exhibit were redacted pursuant to a confidential treatment request filed with the Secretary of the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
|
**
|
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, 2013
|
|||||||
/s/
David Lawrence, M.B.A.
David Lawrence, M.B.A.
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
February 28, 2013
|
|||||||
/s/
Barry Greene
Barry Greene
|
Director
|
February 28, 2013
|
|||||||
/
s
/ Peder K. Jensen, M.D.
Peder K. Jensen, M.D.
|
Director
|
February 28, 2013
|
|||||||
/s/
John P. Kelley
John P. Kelley
|
Director
|
February 28, 2013
|
|||||||
/s/
Sandra Panem, Ph.D.
Sandra Panem, Ph.D.
|
Director
|
February 28, 2013
|
|||||||
/s/
Lorin J. Randall
Lorin J. Randall
|
Director
|
February 28, 2013
|
|||||||
/s/
Steven M. Rauscher, M.B.A.
Steven M. Rauscher, M.B.A.
|
Director
|
February 28, 2013
|
|||||||
/s/
Ian Smith
Ian Smith
|
Director
|
February 28, 2013
|
|
"Agreement"
|
Preamble
|
|
"Confidential Information"
|
Section 8.1
|
|
"[***]"
|
Section 7.4(c)
|
|
"Development Milestone"
|
Section 7.1.2
|
|
"Development Plan"
|
Section 7.1.1
|
|
"EU-CO"
|
Section 3.1(e)
|
|
"Excused Delay"
|
Section 7.1.3
|
|
"Indemnitee"
|
Section 11.2
|
|
"Indemnitor"
|
Section 11.2
|
|
"JDC"
|
Section 7.1.4(a)
|
|
"Joint Patents"
|
Section 9.1.1
|
|
"Licensee"
|
Preamble
|
|
"Licensor"
|
Preamble
|
|
"Patent Representative"
|
Section 9.1.4
|
|
"Patent Subcommittee"
|
Section 9.1.4
|
|
"Qualified Affiliate"
|
Section 13.4
|
|
"Recipient"
|
Section 8.2
|
|
"Right of Reference"
|
Section 3.5
|
|
"[***]"
|
Section 7.4(c)
|
|
"SK Territory"
|
Section 1.37
|
Milestone Event
|
|
|
(1)
|
Completion of initial Clinical Trial
|
$[***]
|
(2)
|
FDA acceptance for review of first NDA
|
$1,000,000
|
(3)
|
FDA Final Approval of first NDA
|
$[***]
|
plus an additional fee if [***]
|
additional $[***]
|
|
(4)
|
[***]
|
$[***]
|
(5)
|
[***]
|
$[***]
|
(6)
|
[***]
|
$[***]
|
Calendar year Net Sales
|
Royalty Rate
|
Portion less than or equal to $[***] million
|
[***]%
I
|
Portion above $[***] million
|
[***]%
|
|
99, seorin-dong, Jongro-gu,
|
|
Seoul, the Republic of Korea
|
|
1289 Fordham Blvd, Suite 327
|
|
Chapel Hill, NC 27514
|
|
Attention: Joseph Sollee
|
|
9001 Aerial Center Parkway, Suite 110
|
|
Morrisville, NC 27560
|
|
Attention: Moise Khayrallah
|
|
5410 Trinity Road, Suite 400
|
|
Raleigh, North Carolina 27607
|
|
Attention: William N. Wofford
|
No.
|
Related USSN/Title of Invention/Inventor
|
PCT Appln. Date/No.
|
Designated
|
Our Ref.
|
Status
|
Etc.
|
Right Status
|
Term of Patent
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|||||
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
|
||||||
[***]
|
[***]
|
[***]
|
[***]
|
List
|
No
.
|
Detailed document title
|
Request
|
||
1.
[***]
|
|||||
2.
[***]
|
|||||
[***]
|
2-1-1
|
[***]
|
x
|
||
2-1-2
|
[***]
|
X
|
|||
[***]
|
2-3-1
|
[***]
|
X
|
||
2-3-2
|
[***]
|
||||
2-3-3
|
[***]
|
X
|
|||
2-3-4
|
[***]
|
X
|
|||
[***]
|
2-4-1
|
[***]
|
X
|
||
2-4-2
|
[***]
|
[***]
|
X
|
||
2-4-3
|
[***]
|
X
|
|||
2-4-4
|
[***]
|
X
|
|||
2-4-5
|
[***]
|
[***]
|
X
|
||
2-4-6
|
[***]
|
X
|
|||
2-4-7
|
[***]
|
X
|
|||
2-4-8
2-4-9
|
[***]
[***]
|
X
X
|
|||
[***]
|
2-5-1
|
[***]
|
|||
2-5-2
|
[***]
|
||||
[***]
|
2-6-1
|
[***]
|
|||
[***]
|
2-7-1
|
[***]
|
|||
[***]
|
2-8-1
|
[***]
|
X
|
||
2-8-2
|
[***]
|
X
|
|||
2-8-3
|
[***]
|
X
|
|||
3.
[***]
|
|||||
[***]
|
3-1-1
|
[***]
|
X
|
||
[***]
|
3-2-1
|
[***]
|
X
|
||
[***]
|
3-3-1
|
[***]
|
X
|
[***]
|
3-4-1
|
[***]
|
X
|
4. [***]
|
|||
[***]
|
4-1-1
|
[***]
|
X
|
4-1-2
|
[***]
|
X
|
|
[***]
|
4-2-1
|
[***]
|
X
|
4-2-2
|
[***]
|
X
|
|
[***]
|
4-3-1
|
[***]
|
X
|
4-3-2
|
[***]
|
X
|
|
[***]
|
4-4-1
|
[***]
|
X
|
5. [***]
|
|||
[***]
|
5-1-1
|
[***]
|
X
|
5-1-2
|
[***]
|
X
|
|
[***]
|
5-2-1
|
[***]
|
X
|
5-2-2
|
[***]
|
||
5-2-3
|
[***]
|
X
|
Event
|
Anticipated R&D Expense
|
Date
|
[***]
|
[***]
|
|
[***]
|
$[***]M
|
[***]
|
[***]
|
$[***]-$[***]M
Over [***]
|
[***]
|
[***]
|
[***]
|
(1)
|
Registration Statement (Form S-3 Nos. 333-164312 and 333-152826)
|
(2)
|
Registration Statement (Form S-8 Nos. 333-164626, 333-158085, 333-131846, 333-149726
, 333-174785, and 333-179906
)
|
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.
|