ACORDA THERAPEUTICS INC, 10-K filed on 2/28/2013
Annual Report
Document and Entity Information (USD $)
12 Months Ended
Dec. 31, 2012
Feb. 15, 2013
Jun. 29, 2012
Document and Entity Information
 
 
 
Entity Registrant Name
ACORDA THERAPEUTICS INC 
 
 
Entity Central Index Key
0001008848 
 
 
Document Type
10-K 
 
 
Document Period End Date
Dec. 31, 2012 
 
 
Amendment Flag
false 
 
 
Current Fiscal Year End Date
--12-31 
 
 
Entity Well-known Seasoned Issuer
Yes 
 
 
Entity Voluntary Filers
No 
 
 
Entity Current Reporting Status
Yes 
 
 
Entity Filer Category
Large Accelerated Filer 
 
 
Entity Public Float
 
 
$ 524,746,202 
Entity Common Stock, Shares Outstanding
 
40,280,070 
 
Document Fiscal Year Focus
2012 
 
 
Document Fiscal Period Focus
FY 
 
 
Consolidated Balance Sheets (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
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 
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 
Consolidated Balance Sheets (Parenthetical) (USD $)
In Thousands, except Share data, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Consolidated Balance Sheets
 
 
Trade accounts receivable, allowances (in dollars)
$ 555 
$ 879 
Common stock, par value (in dollars per share)
$ 0.001 
$ 0.001 
Common stock, Authorized shares
80,000,000 
80,000,000 
Common stock, issued shares
39,804,493 
39,328,495 
Common stock, outstanding shares
39,804,493 
39,328,495 
Treasury stock, shares
12,420 
12,420 
Consolidated Statements of Operations (USD $)
In Thousands, except Per Share data, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 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)
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 (in dollars per share)
$ 3.93 
$ 0.78 
$ (0.31)
Net income (loss) per share-diluted (in dollars per share)
$ 3.84 
$ 0.76 
$ (0.31)
Weighted average common shares outstanding used in computing net income (loss) per share-basic (in shares)
39,459 
39,000 
38,355 
Weighted average common shares outstanding used in computing net income (loss) per share-diluted (in shares)
40,332 
40,064 
38,355 
Consolidated Statements of Comprehensive Income (Loss) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Consolidated Statements of Comprehensive Income (Loss)
 
 
 
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)
Consolidated Statements of Changes in Stockholders' Equity (USD $)
In Thousands, except Share data, unless otherwise specified
Total
Common stock
Treasury stock
Additional paid-in capital
Accumulated deficit
Accumulated other comprehensive income (loss)
Balance at Dec. 31, 2009
$ 137,333 
$ 38 
$ 0 
$ 565,503 
$ (428,317)
$ 109 
Balance (in shares) at Dec. 31, 2009
 
37,935,000 
 
 
 
 
Increase (Decrease) in Stockholders' Equity
 
 
 
 
 
 
Compensation expense for issuance of stock options to employees
12,464 
 
 
12,464 
 
 
Compensation expense for issuance of restricted stock to employees
4,984 
 
(329)
5,313 
 
 
Compensation expense for issuance of restricted stock to employees (in shares)
 
196,000 
 
 
 
 
Exercise of stock options
8,370 
 
8,369 
 
 
Exercise of stock options (in shares)
 
648,000 
 
 
 
 
Other comprehensive income (loss), net of tax
(121)
 
 
 
 
(121)
Net income (loss)
(11,769)
 
 
 
(11,769)
 
Balance at Dec. 31, 2010
151,261 
39 
(329)
591,649 
(440,086)
(12)
Balance (in shares) at Dec. 31, 2010
 
38,779,000 
 
 
 
 
Increase (Decrease) in Stockholders' Equity
 
 
 
 
 
 
Compensation expense for issuance of stock options to employees
13,675 
 
 
13,675 
 
 
Compensation expense for issuance of restricted stock to employees
5,628 
 
 
5,628 
 
 
Compensation expense for issuance of restricted stock to employees (in shares)
 
220,000 
 
 
 
 
Exercise of stock options
3,962 
 
 
3,962 
 
 
Exercise of stock options (in shares)
 
329,000 
 
 
 
 
Other comprehensive income (loss), net of tax
78 
 
 
 
 
78 
Net income (loss)
30,605 
 
 
 
30,605 
 
Balance at Dec. 31, 2011
205,209 
39 
(329)
614,914 
(409,481)
66 
Balance (in shares) at Dec. 31, 2011
39,328,495 
39,328,000 
 
 
 
 
Increase (Decrease) in Stockholders' Equity
 
 
 
 
 
 
Compensation expense for issuance of stock options to employees
15,206 
 
 
15,206 
 
 
Compensation expense for issuance of restricted stock to employees
6,212 
 
 
6,212 
 
 
Compensation expense for issuance of restricted stock to employees (in shares)
 
224,000 
 
 
 
 
Exercise of stock options
4,340 
 
4,339 
 
 
Exercise of stock options (in shares)
 
252,000 
 
 
 
 
Other comprehensive income (loss), net of tax
(4)
 
 
 
 
(4)
Net income (loss)
154,958 
 
 
 
154,958 
 
Balance at Dec. 31, 2012
$ 385,921 
$ 40 
$ (329)
$ 640,671 
$ (254,523)
$ 62 
Balance (in shares) at Dec. 31, 2012
39,804,493 
39,804,000 
 
 
 
 
Consolidated Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 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)
(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 
 
Organization and Business Activities
Organization and Business Activities

(1) Organization and Business Activities

 

Acorda Therapeutics, Inc. (“Acorda” or the “Company”) is a commercial stage biopharmaceutical company dedicated to the identification, development and commercialization of novel therapies that improve neurological function in people with multiple sclerosis (MS), spinal cord injury (SCI) and other disorders of the central nervous system.

 

The management of the Company is responsible for the accompanying audited consolidated financial statements and the related information included in the notes to the consolidated financial statements. In the opinion of management, the audited consolidated financial statements reflect all adjustments, including normal recurring adjustments necessary for the fair presentation of the Company’s financial position and results of operations and cash flows for the periods presented.

Summary of Significant Accounting Policies
Summary of Significant Accounting Policies

(2) Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America and include the results of operations of the Company and its majority owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

 

Use of Estimates

 

The preparation of the consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include share-based compensation accounting, which are largely dependent on the fair value of the Company’s equity securities. In addition, the Company recognizes Zanaflex revenue based on estimated prescriptions filled. The Company adjusts its Zanaflex inventory value based on an estimate of inventory that may be returned. Actual results could differ from those estimates.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid debt instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund and US Treasury bonds, which are unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature.

 

Restricted Cash

 

Restricted cash represents a certificate of deposit placed by the Company with a bank for issuance of a letter of credit to the Company’s lessor for office space and a bank account with funds to cover its self-funded employee health insurance.

 

Investments

 

Both short-term and long-term investments consist of US Treasury bonds. The Company classifies marketable securities available to fund current operations as short-term investments in current assets on its consolidated balance sheets. Marketable securities are classified as long-term investments in long-term assets on the consolidated balance sheets if the Company has the ability and intent to hold them and such holding period may be longer than one year. The Company classifies its short-term and long-term investments as available-for-sale. Available-for-sale securities are recorded at fair value of the investments based on quoted market prices.

 

Unrealized holding gains and losses on available-for-sale securities, which are determined to be temporary, are excluded from earnings and are reported as a separate component of accumulated other comprehensive income (loss).

 

Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective-interest method. Dividend and interest income are recognized when earned. Amortized premiums and discounts, dividend and interest income and realized gains and losses are included in interest income.

 

Inventory

 

Inventory is stated at the lower of cost or market value and includes amounts for Ampyra, Zanaflex tablet and Zanaflex Capsule inventories and is recorded at its net realizable value. Inventories consist of finished goods inventory. Cost is determined using the first-in, first-out method (FIFO) for all inventories. The Company adjusts its inventory value based on an estimate of inventory that may be returned or not sold based on sales projections and establishes reserves as necessary for obsolescence and excess inventory.

 

Ampyra

 

The cost of Ampyra inventory manufactured by Alkermes plc (Alkermes) is based on specified prices calculated as a percentage of net product sales of the product shipped by Alkermes to Acorda. In the event Alkermes does not manufacture the products, Alkermes is entitled to a compensating payment for the quantities of product provided by Patheon, the Company’s alternative manufacturer. This compensating payment is included in the Company’s inventory balances.

 

Property and Equipment

 

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on the straight-line basis over the estimated useful lives of the assets, which ranges from two to seven years. Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on the straight-line basis over the shorter of the useful lives of the assets or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred.

 

Intangible Assets

 

The Company has recorded intangible assets related to milestones for Ampyra and for certain website development costs. These intangible assets are amortized on a straight line basis over the period in which the Company expects to receive economic benefit and are reviewed for impairment when facts and circumstances indicate that the carrying value of the asset may not be recoverable. The determination of the expected life will be dependent upon the use and underlying characteristics of the intangible asset. In the Company’s evaluation of the intangible assets, it considers the term of the underlying asset life and the expected life of the related product line. If the carrying value is not recoverable, impairment is measured as the amount by which the carrying value exceeds its estimated fair value. Fair value is generally estimated based on either appraised value or other valuation techniques.

 

Impairment of Long-Lived Assets

 

The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Any write-downs are treated as permanent reductions in the carrying amount of the assets.

 

Patent Costs

 

Patent application and maintenance costs are expensed as incurred.

 

Research and Development

 

Research and development expenses include the costs associated with the Company’s internal research and development activities, including salaries and benefits, occupancy costs, and research and development conducted for it by third parties, such as contract research organizations (CROs), sponsored university-based research, clinical trials, contract manufacturing for its research and development programs, and regulatory expenses.  In addition, research and development expenses include the cost of clinical trial drug supply shipped to the Company’s clinical study vendors. For those studies that the Company administers itself, the Company accounts for its clinical study costs by estimating the patient cost per visit in each clinical trial and recognizes this cost as visits occur, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. For those studies for which the Company uses a CRO, the Company accounts for its clinical study costs according to the terms of the CRO contract. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. As actual costs become known to the Company, it adjusts the accrual; such changes in estimate may be a material change in its clinical study accrual, which could also materially affect its results of operations. All research and development costs are expensed as incurred except when accounting for nonrefundable advance payments for goods or services to be used in future research and development activities.  These payments are capitalized at the time of payment and expensed ratably over the period the research and development activity is performed.

 

Accounting for Income Taxes

 

The Company provides for income taxes in accordance with ASC Topic 740 (ASC 740). Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized.

 

In determining whether a tax position is effectively settled for the purpose of recognizing previously unrecognized tax benefits, a two-step process is utilized whereby the threshold for recognition is a more likely-than-not test that the tax position will be sustained upon examination and the tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement.

 

Revenue Recognition

 

Ampyra

 

Ampyra is available only through a network of specialty pharmacy providers that provide the medication to patients by mail; Kaiser Permanente (Kaiser), which distributes Ampyra to patients through a closed network of on-site pharmacies; and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate), which is the exclusive specialty pharmacy distributor for Ampyra to the U.S. Department of Veterans Affairs (VA). Ampyra is not available in retail pharmacies. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes product sales of Ampyra following shipment of product to a network of specialty pharmacy providers, Kaiser, and the specialty distributor to the VA. The specialty pharmacy providers, Kaiser, and the specialty distributor to the VA are contractually obligated to hold no more than an agreed number of days of inventory, ranging from between 10 to 30 days.

 

The Company’s net revenues represent total revenues less allowances for customer credits, including estimated rebates, discounts and returns. These allowances are recorded for cash consideration given by a vendor to a customer that is presumed to be a reduction of the selling prices of the vendor’s products or services and, therefore, are characterized as a reduction of revenue. At the time product is shipped to specialty pharmacies, Kaiser and the specialty distributor to the VA, an adjustment is recorded for estimated rebates, discounts and returns. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for rebates, discounts and returns are established based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products.  Product shipping and handling costs are included in cost of sales. Effective December 1, 2012, the Company no longer accepts returns of Ampyra with the exception of product damages that occur during shipping.

 

Zanaflex

 

The Company applies the revenue recognition guidance in Accounting Standards Codification (ASC) 605-15-25, which among other criteria requires that future returns can be reasonably estimated in order to recognize revenue. The amount of future tablet returns is uncertain due to generic competition and customer conversion to Zanaflex Capsules. The Company has accumulated some sales history with Zanaflex Capsules; however, due to existing and potential generic competition and customer conversion from Zanaflex tablets to Zanaflex Capsules, we do not believe we can reasonably determine a return rate at this time. As a result, the Company accounts for these product shipments using a deferred revenue recognition model. Under the deferred revenue model, the Company does not recognize revenue upon product shipment. For these product shipments, the Company invoices the wholesaler, records deferred revenue at gross invoice sales price, and classifies the cost basis of the product held by the wholesaler as a component of inventory. The Company recognizes revenue when prescribed to the end-user, on a first-in first-out (FIFO) basis. The Company’s revenue to be recognized is based on (1) the estimated prescription demand, based on pharmacy sales for its products; and (2) the Company’s analysis of third party information, including third party market research data. The Company’s estimates are subject to the inherent limitations of estimates that rely on third party data, as certain third party information is itself in the form of estimates, and reflect other limitations. The Company’s sales and revenue recognition reflects the Company’s estimates of actual product prescribed to the end-user. The Company expects to be able to apply a more traditional revenue recognition policy such that revenue is recognized following shipment to the customer when it believes it has sufficient data to develop reasonable estimates of expected returns based upon historical returns and greater certainty regarding generic competition.

 

The Company’s net revenues represent total revenues less allowances for customer credits, including estimated discounts, rebates, and chargebacks. These allowances are recorded for cash consideration given by a vendor to a customer that is presumed to be a reduction of the selling prices of the vendor’s products or services and, therefore, should be characterized as a reduction of revenue when recognized in the vendor’s statement of operations. Adjustments are recorded for estimated chargebacks, rebates, and discounts. These allowances are established by management as its best estimate based on available information and are adjusted to reflect known changes in the factors that impact such allowances. Allowances for chargebacks, rebates and discounts are established based on the contractual terms with customers, analysis of historical levels of discounts, chargebacks and rebates, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for each product and anticipated introduction of competitive products. In addition, the Company records a charge to cost of goods sold for the cost basis of the estimated product returns the Company believes may ultimately be realized at the time of product shipment to wholesalers. The Company has recognized this charge at the date of shipment since it is probable that it will receive a level of returned products; upon the return of such product it will be unable to resell the product considering its expiration dating; and it can reasonably estimate a range of returns. This charge represents the cost basis for the low end of the range of the Company’s estimated returns. Product shipping and handling costs are included in cost of sales.

 

Milestones and royalties

 

In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones using the criteria as provided by the Financial Accounting Standards Boards (FASB) guidance on the milestone method of revenue recognition. At the inception of a collaboration agreement the Company evaluates if payments are substantive.  The criteria requires that (i) the Company determines if the milestone is commensurate with either its performance to achieve the milestone or the enhancement of value resulting from the Company’s activities to achieve the milestone, (ii) the milestone be related to past performance, and (iii) the milestone be reasonably relative to all deliverable and payment terms of the collaboration arrangement.  If these criteria are met then the contingent milestones can be considered as substantive milestones and will be recognized as revenue in the period that the milestone is achieved. Royalties are recognized as earned in accordance with the terms of various research and collaboration agreements.

 

Collaborations

 

The Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it shall be accounted for as a separate element or single unit of accounting. If an element shall be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue shall be recognized. If an element shall not be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue shall be recognized. Payments received in excess of revenues recognized are recorded as deferred revenue until such time as the revenue recognition criteria have been met.

 

Concentration of Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of investments in cash, cash equivalents, restricted cash and accounts receivable. The Company maintains cash, cash equivalents, restricted cash, short-term and long-term investments with approved financial institutions. The Company is exposed to credit risks and liquidity in the event of default by the financial institutions or issuers of investments in excess of FDIC insured limits. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any institution.

 

The Company does not own or operate, and currently does not plan to own or operate, facilities for production and packaging of Ampyra or its other commercial products, Zanaflex Capsules or Zanaflex tablets. It relies and expects to continue to rely on third parties for the production and packaging of its commercial products and clinical trial materials for those and other products.

 

The Company relies on Alkermes to supply us with its requirements for Ampyra.  Under its supply agreement with Alkermes, the Company is obligated to purchase at least 75% of its yearly supply of Ampyra from Alkermes, and it is required to make compensatory payments if it does not purchase 100% of its requirements from Alkermes, subject to specified certain exceptions. The Company and Alkermes have agreed that it may purchase up to 25% of its annual requirements from Patheon, a mutually agreed-upon second manufacturing source, with compensatory payment.  The Company and Alkermes also rely on a single third-party manufacturer, Regis, to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra.  If Regis experiences any disruption in their operations, a delay or interruption in the supply of Ampyra product could result until Regis cures the problem or we locate an alternate source of supply.

 

The Company’s principal direct customers as of December 31, 2012 were a network of specialty pharmacies, Kaiser, and the specialty distributor to the VA for Ampyra and wholesale pharmaceutical distributors for Zanaflex Capsules and Zanaflex tablets. The Company periodically assesses the financial strength of these customers and establishes allowances for anticipated losses, if necessary.

 

Allowance for Cash Discounts

 

An allowance for cash discounts is accrued based on historical usage rates at the time of product shipment.  The Company adjusts accruals based on actual activity as necessary.  Cash discounts are typically settled with customers within 30 days after the end of each calendar month.  The Company has cash discount allowances of $3.2 million and $3.4 million for the years ended December 31, 2012 and 2011, respectively.  The Company’s accruals for cash discount allowances were $293,000 and $303,000 as of December 31, 2012 and 2011, respectively.

 

Allowance for Doubtful Accounts

 

A portion of the Company’s accounts receivable may not be collected due principally to customer disputes and sales returns. The Company provides reserves for these situations based on the evaluation of the aging of its trade receivable portfolio and an analysis of high-risk customers. The Company has not historically experienced losses related to credit risk.  The Company has recognized an allowance related to one customer of approximately $260,000 and $600,000 as of December 31, 2012, and December 31, 2011, respectively.  For the year ended December 31, 2012, the Company recorded a provision of $60,000 and write-offs of $400,000.  For the year ended December 31, 2011, the Company recorded a provision of $600,000 and did not record any write-offs.

 

Contingencies

 

The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. Litigation expenses are expensed as incurred.

 

Fair Value of Financial Instruments

 

The fair value of a financial instrument represents the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. Significant differences can arise between the fair value and carrying amounts of financial instruments that are recognized at historical cost amounts. The Company considers that fair value should be based on the assumptions market participants would use when pricing the asset or liability.

 

The following methods are used to estimate the fair value of Company’s financial instruments:

 

(a)                                 Cash equivalents, grants receivables, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to the short-term nature of these instruments;

 

(b)                                 Available-for-sale securities are recorded based primarily on quoted market prices;

 

(c)                                  Put/call liability’s fair value is based on revenue projections and business, general economic and market conditions that could be reasonably evaluated as of the valuation date;

 

It is not practical for the Company to estimate the fair value of the convertible notes payable due to the specific provisions of these notes. The terms of these notes are disclosed at Note 9. See Note 14 for discussion on fair value measurements.

 

Earnings per Share

 

Basic net income (loss) per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method) and the vesting of restricted stock.  In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. Common equivalent shares have not been included in the net income (loss) per share calculations for the year ended 2010 because the effect of including them would have been anti-dilutive.   See Note 7 for discussion on earnings per share.

 

Share-based Compensation

 

The Company has various share-based employee and non-employee compensation plans, which are described more fully in Note 6.

 

The Company accounts for stock options and restricted stock granted to employees and non-employees by recognizing the costs resulting from all share-based payment transactions in the consolidated financial statements at their fair values. The Company estimates the fair value of each option on the date of grant using the Black-Scholes closed-form option-pricing model based on assumptions of expected volatility of its common stock, prevailing interest rates, an estimated forfeiture rate, and the expected term of the stock options and we recognize that cost as an expense ratably over the associated employee service period.

 

Segment Information

 

The Company is managed and operated as one business. The entire business is managed by a single management team that reports to the chief executive officer. The Company does not operate separate lines of business with respect to any of its products or product candidates. Accordingly, the Company does not prepare discrete financial information with respect to separate products or product candidates or by location and does not have separately reportable segments.

 

Comprehensive Income

 

Unrealized gains (losses) from the Company’s investment securities are included in accumulated other comprehensive income (loss) within the consolidated balance sheet.

 

Recent Accounting Pronouncements

 

In June 2011, the FASB issued an accounting standards update regarding the presentation of comprehensive income in financial statements. The provisions of this standard provide an option to present the components of net income and other comprehensive income either as one continuous statement of comprehensive income or as two separate but consecutive statements. The Company reports components of comprehensive income in two separate consecutive statements in accordance with the Financial Accounting Standard Board’s amended guidance on the presentation of comprehensive income. The new guidance was effective for the Company January 1, 2012.

 

In May 2011, the FASB issued ASU No. 2011-04, “Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs” (ASU 2011-04). This newly issued accounting standard clarifies the application of certain existing fair value measurement guidance and expands the disclosures for fair value measurements that are estimated using significant unobservable (Level 3) inputs. The provisions of this new disclosure standard are effective January 1, 2012.  This accounting standard update did not have a material effect on the Company’s financial statements.

 

Subsequent Events

 

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were no subsequent events requiring disclosure in or requiring adjustment to these financial statements.

Investments
Investments

(3) Investments

 

The Company has determined that all of its investments are classified as available-for-sale. Available-for-sale securities are carried at fair value with interest on these securities included in interest income and are recorded based primarily on quoted market prices. Available-for-sale securities consisted of the following:

 

(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

 

 

The Company’s short-term and long-term investments consist of US Treasury bonds. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in carrying amount to fair value. The impairment would be charged to earnings for the difference between the investment’s cost and fair value at such date and a new cost basis for the security established. Factors evaluated to determine if an investment is other-than-temporarily impaired include significant deterioration in the earnings performance, credit rating, asset quality, or business prospects of the issuer; adverse changes in the general market condition in which the issuer operates; the intent and ability to retain the investment for a sufficient period of time to allow for recovery in the market value of the investment; and, issues that raise concerns about the issuer’s ability to continue as a going concern. The Company has determined that there were no other-than-temporary declines in the fair values of its short term investments as of December 31, 2012.

 

Short-term investments with maturity of three months or less from date of purchase have been classified as cash and cash equivalents, and amounted to $27.9 million and $38.3 million as of December 31, 2012 and 2011, respectively. Short-term investments have original maturities of greater than 3 months but less than 1 year and long-term investments are greater than 1 year and up to 16 months.

Property and Equipment
Property and Equipment

(4) Property and Equipment

 

Property and equipment consisted of the following:

 

(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

 

 

 

 

Depreciation and amortization expense on property and equipment was $2.7 million and $1.5 million for the years ended December 31, 2012 and 2011, respectively.

Accrued Expenses and Other Current Liabilities
Accrued Expenses and Other Current Liabilities

(5) Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities consisted of the following:

 

(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

 

Common Stock Options and Restricted Stock
Common Stock Options and Restricted Stock

(6) Common Stock Options and Restricted Stock

 

On June 18, 1999, the Company’s board of directors approved the adoption of the Acorda Therapeutics, Inc. 1999 Employee Stock Option Plan (the 1999 Plan). All employees of the Company were eligible to participate in the 1999 Plan, including executive officers, as well as directors, independent contractors, and agents of the Company. The number of shares authorized for issuance under the 1999 Plan was 2,481,334.

 

On January 12, 2006, the Company’s board of directors approved the adoption of the Acorda Therapeutics, Inc. 2006 Employee Incentive Plan (the 2006 Plan). This 2006 Plan serves as the successor to the Company’s 1999 Plan, as amended, and no further option grants or stock issuances shall be made under the 1999 Plan after the effective date, as determined under Section 14 of the 2006 Plan. All employees of the Company are eligible to participate in the 2006 Plan, including executive officers, as well as directors, independent contractors, and agents of the Company. The 2006 Plan also covers the issuance of restricted stock. The 2006 Plan is administered by the Compensation Committee of the Board of Directors, which selects the individuals to be granted options and restricted stock, determines the time or times at which options and restricted stock shall be granted under the 2006 Plan, determines the number of shares to be granted subject to any option or restricted stock under the 2006 Plan and the duration of each option and restricted stock, and makes any other determinations necessary, advisable, and/or appropriate to administer the 2006 Plan. Under the 2006 Plan, each option granted expires no later than the tenth anniversary of the date of its grant. The number of shares of common stock reserved for issuance pursuant to awards made under the 2006 Plan as of December 31, 2012 is 9,954,385 shares of stock. The total number of shares of common stock available for issuance under this 2006 Plan, including shares of common stock subject to the then outstanding awards, shall automatically increase on January 1 of each year during the term of this plan, beginning 2007, by a number of shares of common stock equal to 4% of the outstanding shares of common stock on that date, unless otherwise determined by the Board of Directors. The Board approved the automatic increases of 4% for 2012, 2011, and 2010. Upon the exercise of options in the future, the Company intends to issue new shares.

 

The fair value of each option granted is estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions:

 

 

 

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

 

 

 

 

 

The Company estimated volatility for purposes of computing compensation expense on its employee and non-employee options using the historic volatility of the Company’s stock price. The expected life used to estimate the fair value of employee options is 5.64 years which is based on the historical life of the Company’s options based on exercise data.

 

The weighted average fair value per share of options granted to employees and directors for the years ended December 31, 2012, 2011 and 2010 amounted to approximately $13.67, $13.02, and $19.29, respectively. No options were granted to non-employees for the years ended December 31, 2012, 2011 and 2010.

 

During the year ended December 31, 2012, the Company granted 1,612,037 stock options and restricted stock awards to employees and directors under the 2006 Plan. These stock options were issued with a weighted average exercise price of $25.69 per share. 500 of these options vested immediately, 71,372 of these options vest over a one-year vesting schedule and 1,219,982 will vest over a four-year vesting schedule. The 320,183 restricted stock awards granted in 2012 vest over a four-year vesting schedule. As a result of these grants the total compensation charge to be recognized over the service period is $24.4 million, of which $5.5 million was recognized during the year ended December 31, 2012.

 

Compensation costs for options and restricted stock granted to employees and directors amounted to $21.4 million, $19.3 million, and $17.8 million, for the years ended December 31, 2012, 2011 and 2010, respectively. There were no compensation costs capitalized in inventory balances. Compensation expense for options and restricted stock granted to employees and directors are classified between research and development, sales and marketing and general and administrative expense based on employee job function.

 

The following table summarizes share-based compensation expense included within our consolidated statements of operations:

 

 

 

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

 

 

A summary of share-based compensation activity for the year ended December 31, 2012 is presented below:

 

Stock Option Activity

 

 

 

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 Activity

 

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

 

 

Unrecognized compensation cost for unvested stock options and restricted stock awards as of December 31, 2012 totaled $36.0 million and is expected to be recognized over a weighted average period of approximately 2.4 years.

Earnings Per Share
Earnings Per Share

(7) Earnings Per Share

 

The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2012, 2011 and 2010:

 

(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

)

 

The difference between basic and diluted shares is that diluted shares include the dilutive effect of the assumed exercise of outstanding securities. The Company’s stock options and unvested shares of restricted common stock could have the most significant impact on diluted shares.

 

Securities that could potentially be dilutive are excluded from the computation of diluted earnings per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts.

 

The following amounts were not included in the calculation of net income per diluted share because their effects were anti-dilutive:

 

(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

 

 

Income Taxes
Income Taxes

(8) Income Taxes

 

The income tax provision (benefit) is based on income before income taxes as follows:

 

(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

)

 

The benefit from/(provision for) income taxes in 2012, 2011 and 2010 consists of current and deferred federal, state and foreign taxes as follows:

 

(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 the fourth quarter of 2012, the Company reversed the valuation allowance recorded against its net deferred tax assets. The decision to reverse the valuation allowance in full was made after management determined, based on an assessment of historical profitability and forecasts of future taxable income, that it was more likely than not that these deferred tax assets would be realized. It will continue to evaluate the necessity for a valuation allowance on these and future net deferred tax assets based on available evidence at each reporting period in conformity with ASC 740.

 

Due to the amount of net operating loss (NOL) and tax credit carryforwards, the Company does not currently pay substantial U.S. federal income taxes. The Company expects to pay cash taxes in various US states and Puerto Rico where it has operations and NOL carryforwards are not available. The Company was subject to the alternative minimum tax during 2011 and 2012 and expects to be subject to cash payments for this in the near term. The payment of an alternative minimum tax amount generates a credit that may be carried forward indefinitely and used to offset our regular income tax liability.

 

The Company had available federal NOL carryforwards of approximately $205.1 million and $229.7 million and state NOL carryforwards of approximately $19.4 million and $34.0 million as of December 31, 2012 and 2011, respectively, which are available to offset future taxable income. A tax benefit of $8.6 million associated with the exercise of stock options will be recorded in additional paid-in capital when the associated net operating loss is recognized. The federal losses are expected to expire between 2023 and 2030 while the state losses are expected to expire during similar periods, although not all states conform to the federal carryforward period and occasionally limit the use of net operating losses for a period of time. The Company is no longer subject to federal or state income tax audits for tax years prior to 2007 however, such taxing authorities can review any net operating losses utilized by the Company in years subsequent to 1999. The Company also has research and development credit carry-forwards of $4.4 million and $4.2 million as of December 31, 2012 and 2011, respectively are subject to expiration starting in 2029. The Company also has Alternative Minimum Tax credit carry-forwards of $1.8 million and $1.1 million as of December 31, 2012 and 2011, respectively.  Such credits can be carried forward indefinitely and have no expiration date.

 

The Tax Reform Act of 1986 contains certain provisions that can limit a taxpayer’s ability to utilize net operating loss and tax credit carryforwards in any given year resulting from cumulative changes in ownership interests in excess of 50 percent over a three-year period. We have determined that these limiting provisions were triggered during a prior year and in the current year in connection with the Neuronex acquisition. However, we believe that such limitation is not expected to result in the expiration or loss of any of our federal NOL’s and income tax credit carryforwards. Future ownership changes may limit the use of these carryforwards.

 

The provision (benefit) for income taxes differs from the U.S. federal statutory tax rate. The reconciliation of the statutory U.S. federal income tax rate to our effective income tax rate is as follows:

 

(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

%

 

 

Provisions have been made for deferred taxes based on the differences between the basis of the assets and liabilities for financial statement purposes and the basis of the assets and liabilities for tax purposes using currently enacted tax rates and regulations that will be in effect when the differences are expected to be recovered or settled. The components of the deferred tax assets and liabilities are as follows:

 

(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

 

$

 

 

The Company follows authoritative guidance regarding accounting for uncertainty in income taxes, which prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.

 

The beginning and ending amounts of unrecognized tax benefits reconciles as follows:

 

(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

 

$

 

$

 

 

Due to the amount of the Company’s NOLs and tax credit carryforwards, it has not accrued interest relating to these unrecognized tax benefits. Accrued interest and penalties, however, would be disclosed within the related liabilities lines in the consolidated balance sheet and recorded as a component of income tax expense. Unless related to excess tax benefits from stock options, all of our unrecognized tax benefits, if recognized, would impact the effective tax rate.

 

The Company files federal and state income tax returns in the U.S. and Puerto Rico. The U.S. and Puerto Rico have statute of limitations ranging from 3 to 5 years. However, the statute of limitations could be extended due to the Company’s NOL carryforward position in a number of its jurisdictions. The tax authorities, generally, have the ability to review income tax returns for periods where the statute of limitation has previously expired and can subsequently adjust the NOL carryforward or tax credit amounts. Accordingly, the Company does not expect to reverse any portion of the unrecognized tax benefits within the next year.

License, Research and Collaboration Agreements
License, Research and Collaboration Agreements

(9) License, Research and Collaboration Agreements

 

Alkermes plc, formerly Elan plc

 

The Company has entered into agreements with Elan Corporation plc, including those described immediately below and elsewhere in these financial statements.  In September 2011, Alkermes plc acquired Elan’s Drug Technologies business and Elan transferred our agreements to Alkermes as part of that transaction.  Throughout this report, references to “Alkermes” include Alkermes plc and also, as the context may require, Elan Corporation plc as the predecessor to Alkermes plc under our agreements.

 

The Company is a party to a 2003 amended and restated license agreement and a 2003 supply agreement with Alkermes for Ampyra, which replaced two prior license and supply agreements for Ampyra. Under the license agreement, the Company has exclusive worldwide rights to Ampyra, as well as Alkermes’ formulation for any other mono or di-aminopyridines, for all indications, including multiple sclerosis and spinal cord injury. The Company is obligated to pay Alkermes milestone payments and royalties based on a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda.

 

Subject to early termination provisions, the Alkermes license terminates on a country by country basis on the latter to occur of fifteen years from the date of the agreement, the expiration of the last to expire Alkermes patent or the existence of competition in that country.

 

Under the supply agreement, Alkermes has the right to manufacture for the Company, subject to certain exceptions, Ampyra and other products covered by these agreements at specified prices calculated as a percentage of net product sales of the product shipped by Alkermes to Acorda. In the event Alkermes does not manufacture the products, it is entitled to a compensating payment for the quantities of product provided by the alternative manufacturer.

 

Convertible Note

 

Under the Agreement, Alkermes also loaned to the Company an aggregate of $7.5 million pursuant to two convertible promissory notes. On December 23, 2005, Alkermes transferred these promissory notes to funds affiliated with Saints Capital. One promissory note in the amount of $5.0 million bears interest at a rate of 3% beginning on the first anniversary of the issuance of the note. The original unpaid principal was convertible into 67,476 shares of common stock. As of December 31, 2012 the unpaid principal was convertible into 48,197 shares of common stock. Principal and interest are repayable, if not converted, ratably over a seven-year period beginning one year after the Company receives certain regulatory approval for the products to be developed, subject to limitations related to gross margin on product sales. The $5.0 million promissory note restricts the Company’s ability to incur indebtedness that is senior to the notes, subject to certain exceptions, including for the Company’s revenue interest assignment arrangement (See Note 13).

 

The second promissory note was in the amount of $2.5 million and was non-interest bearing. In December 2006, Saints Capital exercised the conversion of this note into 210,863 shares of common stock.

 

On January 22, 2010, the Company received regulatory approval for the product under development that was subject to this convertible note payable. Saints Capital held the option to convert the outstanding principal into common stock until the first anniversary of regulatory approval or January 22, 2011. Saints Capital did not convert by the first anniversary date, therefore the Company is obligated to pay the outstanding principal sum on the promissory note, together with all accrued and unpaid interest, subject to limitations related to gross margin on product sales, in seven equal installments, the first of which was paid on the maturity date, and the balance shall be paid on the six successive anniversaries of the maturity date. The Company, at its option, may at any time prepay in whole or in part, without penalty, the principal balance together with accrued interest to the date of payment, by giving Saints Capital written notice at least thirty days prior to the date of prepayment.

 

Interest on this convertible promissory note has been recorded using 3% on the $5 million note.

 

Supply Agreement

 

The Company is a party to a 2003 supply agreement with Alkermes relating to the manufacture and supply of Ampyra by Alkermes. The Company is obligated to purchase at least 75% of its 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 Acorda. In those circumstances, where the Company elects to purchase less than 100% of its requirements from Alkermes, the Company is obligated to make certain compensatory payments to Alkermes. Alkermes is required to assist the Company in qualifying a second manufacturer to manufacture and supply the Company with Ampyra subject to its obligations to Alkermes.

 

As permitted by the agreement with Alkermes, the Company has designated Patheon, Inc. (Patheon) as a qualified second manufacturing source of Ampyra. In connection with that designation, Alkermes assisted the Company in transferring manufacturing technology to Patheon. The Company and Alkermes have agreed that a purchase of up to 25% of annual requirements from Patheon is allowed if compensatory payments are made to Alkermes. In addition, Patheon may supply the Company with Ampyra if Alkermes is unable or unwilling to meet the Company’s requirements.

 

Rush-Presbyterian St. Luke’s Medical Center

 

In 1990, Alkermes licensed from Rush know-how relating to dalfampridine (4-aminopyridine, 4-AP, the formulation used in Ampyra), for the treatment of MS. The Company subsequently licensed this know-how from Alkermes. In September 2003, the Company entered into an agreement with Rush and Alkermes terminating the Rush license to Alkermes and providing for mutual releases. The Company also entered into a license agreement with Rush in 2003 in which Rush granted the Company an exclusive worldwide license to its know-how relating to dalfampridine for the treatment of MS. Rush has also assigned to the Company its Orphan Drug Designation for dalfampridine for the relief of symptoms of MS.

 

The Company agreed to pay Rush a license fee, milestone payments of up to $850,000 and royalties based on net sales of the product for neurological indications. The FDA approval of Ampyra triggered the final milestone of $750,000 which was paid during the three-months ended March 31, 2010.  As of December 31, 2010, all milestone obligations were met and the Company had made an aggregate of $850,000 in milestone payments under this agreement.  As of December 31, 2012, the Company made or accrued royalty payments totaling $13.0 million.

 

Biogen Idec

 

On June 30, 2009, the Company entered into an exclusive collaboration and license agreement with Biogen Idec International GmbH (Biogen Idec) to develop and commercialize Ampyra (known as Fampyra outside the U.S.) in markets outside the United States (the “Collaboration Agreement”). Under the Collaboration Agreement, Biogen Idec was granted the exclusive right to commercialize Ampyra and other products containing aminopyridines developed under that agreement in all countries outside of the United States, which grant includes a sublicense of the Company’s rights under an existing license agreement between the Company and Alkermes plc (Alkermes), formerly Elan Corporation, plc (Elan). Biogen Idec has responsibility for regulatory activities and future clinical development of Fampyra in ex-U.S. markets worldwide. The Company also entered into a related supply agreement with Biogen Idec (the “Supply Agreement”), pursuant to which the Company will supply Biogen Idec with its requirements for the licensed products through the Company’s existing supply agreement with Alkermes.

 

Under the Collaboration Agreement, the Company was entitled to an upfront payment of $110.0 million as of June 30, 2009, which was received in July 2009, and a $25 million milestone payment upon approval of the product in the European Union, which was received in August 2011. The Company is also entitled to receive additional payments of up to $10 million based on the successful achievement of future regulatory milestones and up to $365 million based on the successful achievement of future sales milestones. Due to the uncertainty surrounding the achievement of the future regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned. The Company is not able to reasonably predict if and when the milestones will be achieved. Under the Collaboration Agreement, Biogen Idec will be required to make double-digit tiered royalty payments to the Company on ex-U.S. sales. In addition, the consideration that Biogen Idec will pay for licensed products under the Supply Agreement will reflect the price owed to the Company’s suppliers under its supply arrangements with Alkermes or other suppliers for ex-U.S. sales. The Company and Biogen Idec may also carry out future joint development activities regarding licensed product under a cost-sharing arrangement. Under the terms of the Collaboration Agreement, the Company, in part through its participation in joint committees with Biogen Idec, will participate in overseeing the development and commercialization of Ampyra and other licensed products in markets outside the United States pursuant to that agreement. Acorda will continue to develop and commercialize Ampyra independently in the United States.

 

As of June 30, 2009, the Company recorded a license receivable and deferred revenue of $110.0 million for the upfront payment due to the Company from Biogen Idec under the Collaboration Agreement. Also, as a result of such payment to Acorda, a payment of $7.7 million became payable by Acorda to Alkermes and was recorded as a cost of license payable and deferred expense. The payment of $110.0 million was received from Biogen Idec on July 1, 2009 and the payment of $7.7 million was made to Alkermes on July 7, 2009.

 

The Company considered the following deliverables with respect to the revenue recognition of the $110.0 million upfront payment:  (1) the license to use the Company’s technology, (2) the Collaboration Agreement to develop and commercialize licensed product in all countries outside the U.S., and (3) the Supply Agreement. Due to the inherent uncertainty in obtaining regulatory approval, the applicability of the Supply Agreement is outside the control of the Company and Biogen Idec. Accordingly, the Company has determined the Supply Agreement is a contingent deliverable at the onset of the agreement.  As a result, the Company has determined the Supply Agreement does not meet the definition of a deliverable that needs to be accounted for at the inception of the arrangement. The Company has also determined that there is no significant and incremental discount related to the supply agreement since Biogen Idec will pay the same amount for inventory that the Company would pay and the Company effectively acts as a middle man in the arrangement for which it adds no significant value due to various factors such as the Company does not have any manufacturing capabilities or other knowhow with respect to the manufacturing process.

 

The Company has determined that the identified non-contingent deliverables (deliverables 1 and 2 immediately preceding) would have no value on a standalone basis if they were sold separately by a vendor and the customer could not resell the delivered items on a standalone basis, nor does the Company have objective and reliable evidence of fair value for the deliverables. Accordingly, the non-contingent deliverables are treated as one unit of accounting.  As a result, the Company will recognize the non-refundable upfront payment from Biogen Idec as revenue and the associated payment to Alkermes as expense ratably over the estimated term of regulatory exclusivity for the licensed products under the Collaboration Agreement as the Company had determined this was the most probable expected benefit period. The Company recognized $9.1 million in amortized license revenue, a portion of the $110.0 million received from Biogen Idec, and $634,000 in cost of license revenue, a portion of the $7.7 million paid to Alkermes, during each of the twelve-month periods ended December 31, 2012 and 2011.

 

On January 21, 2011 Biogen Idec announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) decided against approval of Fampyra to improve walking ability in adult patients with multiple sclerosis.  Biogen Idec, working closely with the Company, filed a formal appeal of the decision.  In May 2011, the CHMP recommended conditional marketing authorization, and in July 2011 Biogen Idec received conditional approval from the European Commission for, Fampyra (prolonged-release fampridine tablets) for the improvement of walking in adult patients with MS with walking disability (Expanded Disability Status Scale of 4-7). The Company changed the amortization period on a prospective basis during the three-month period ended March 31, 2011 by five months and currently estimates the recognition period to be approximately 12 years from the date of the Collaboration Agreement.

 

As part of its ex-U.S. license agreement, Biogen Idec owes Acorda royalties based on ex-U.S. net sales, and milestones based on ex-U.S. regulatory approval, new indications, and ex-U.S. net sales.  These milestones included a $25 million payment for approval of the product in the European Union which was recorded and paid in the three month period ended September 30, 2011. Based on Acorda’s worldwide license and supply agreement with Alkermes, Alkermes received 7% of this milestone payment from Acorda during the same period.  For revenue recognition purposes, the Company has determined this milestone to be substantive in accordance with applicable accounting guidance related to milestone revenue.  Substantive uncertainty existed at the inception of the arrangement as to whether the milestone would be achieved because of the numerous variables, such as the high rate of failure inherent in the research and development of new products and the uncertainty involved with obtaining regulatory approval. Biogen Idec leveraged Acorda’s U.S. Ampyra study results that contributed to the regulatory approval process. Therefore, the milestone was achieved based in part on Acorda’s past performance.  The milestone was also reasonable relative to all deliverable and payment terms of the collaboration arrangement. Therefore, the payment was recognized in its entirety as revenue and the cost of the milestone revenue was recognized in its entirety as an expense during the three-month period ended September 30, 2011.

 

Cost of milestone and license revenue includes $634,000 in cost of license revenue for the twelve-month periods ended December 31, 2012 and 2011, which represents the amortized portion of the $7.7 million paid to Alkermes in 2009, for both of the twelve-month periods ended December 31, 2012 and 2011.  For the twelve-month period ended December 31, 2011 it also includes $1.8 million in cost of milestone revenue, which represents the 7% Alkermes portion of the $25 million milestone paid during the three-month period ended September 30, 2011.

 

Actavis/Watson

 

The Company has an agreement with Watson Pharma, Inc., a subsidiary of Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.), to market tizanidine hydrochloride capsules, an authorized generic version of Zanaflex Capsules, which was launched in February 2012.  In accordance with the Watson agreement, the Company receives a royalty based on Watson’s gross margin, as defined by the agreement, of the authorized generic product. During the twelve-month period ended December 31, 2012, the Company recognized royalty revenue of $7.2 million related to the gross margin of the Zanaflex Capsule authorized generic.  During the twelve-month period ended December 31, 2012, the Company also recognized revenue and a corresponding cost of sales of $3.1 million related to the purchase and sale of the related Zanaflex Capsule authorized generic product to Watson, which is recorded in net product revenues and cost of sales.

 

Neuronex

 

In December 2012, the Company acquired Neuronex, Inc., a privately-held development stage pharmaceutical company (Neuronex).  Neuronex is developing Diazepam Nasal Spray under Section 505(b)(2) of the Food, Drug and Cosmetic Act 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.

 

Under the terms of the agreement, the Company made an upfront payment of $2.0 million in February 2012.  The Company also paid $1.5 million during the twelve month period ended December 31, 2012 pursuant to a commitment under the agreement to fund research to prepare for the Diazepam Nasal Spray pre-NDA meeting with the FDA.  In December 2012, the Company completed the acquisition by paying $6.8 million to former Neuronex shareholders less a $300,000 holdback provision to be settled in December 2013.

 

The former equity holders of Neuronex are entitled to receive from Acorda up to an additional $18 million in contingent earnout payments upon the achievement of specified regulatory and manufacturing-related milestones with respect to the Diazepam Nasal Spray product, and up to $105 million upon the achievement of specified sales milestones with respect to the Diazepam Nasal Spray product.  The former equity holders of Neuronex will also be entitled to receive tiered royalty-like earnout payments, ranging from the upper single digits to lower double digits, on worldwide net sales of Diazepam Nasal Spray products.  These payments are payable on a country-by-country basis until the earlier to occur of ten years after the first commercial sale of a product in such country and the entry of generic competition in such country as defined in the Agreement.

 

The patent and other intellectual property and other rights relating to the Diazepam Nasal Spray product are licensed from SK Biopharmaceuticals Co., Ltd. (SK).  Pursuant to the SK license, which granted worldwide rights to Neuronex, except certain specified Asian countries, the Company’s subsidiary Neuronex is obligated to pay SK up to $8 million upon the achievement of specified development milestones with respect to the Diazepam Nasal Spray product and up to $3 million upon the achievement of specified sales milestones with respect to the Diazepam Nasal Spray product.  Also, Neuronex is obligated to pay SK a tiered, mid-single digit royalty on net sales of Diazepam Nasal Spray products.

 

The Company evaluated the transaction based upon the guidance of ASC 805, Business Combinations, and concluded that it will only acquire inputs and did not acquire any processes.  The Company will need to develop its own processes in order to produce an output. Therefore the Company accounted for the transaction as an asset acquisition and accordingly the $2.0 million upfront payment, $1.5 million in research funding and $6.8 million of closing consideration net of tangible net assets acquired of $3.7, million which were primarily the taxable amount of net operating loss carryforwards, were expensed as research and development expense during the twelve-month period ended December 31, 2012.

Employee Benefit Plan
Employee Benefit Plan

(10) Employee Benefit Plan

 

Effective September 1, 1999, the Company adopted a defined contribution 401(k) savings plan (the 401(k) plan) covering all employees of the Company. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) plan, subject to defined limitations. Effective January 1, 2007, the Company amended the plan to include an employer match contribution to employee deferrals. For each dollar an employee invests up to 6% of his or her earnings, the Company will contribute an additional 50 cents into the funds. The Company’s expense related to the plan was $1.3 million, $1.1 million and $1.0 million for the years ended December 31, 2012, 2011, and 2010, respectively.

Commitments and Contingencies
Commitments and Contingencies

(11) Commitments and Contingencies

 

Leases

 

The lease for the Company’s former corporate headquarters was scheduled to expire in December 2012.  In connection with the Company entering into a lease for a new headquarters facility in 2011, it exercised its right to accelerate the termination date to June 2012. In June 2011, the Company entered into a 15 year lease for an aggregate of approximately 138,000 square feet of laboratory and office space in Ardsley, New York.  The Company took possession of the new space in July 2012.  The Company has options to extend the term of the lease for three additional five-year periods, and it has an option to terminate the lease after 10 years subject to payment of an early termination fee.  Also, the Company has rights to lease up to approximately 120,000 additional square feet of space in additional buildings at the same location.  Our extension, early termination, and expansion rights are subject to specified terms and conditions, including specified time periods when they must be exercised, and are also subject to limitations including that we not be in default under the lease.  The lease provides for monthly payments of rent during the term. These payments consist of base rent, which takes into account the costs of the facility improvements being funded by the facility owner prior to our occupancy, and additional rent covering customary items such as charges for utilities, taxes, operating expenses, and other facility fees and charges.  The base rent is initially $3.4 million per year, and is subject to a 2.5% annual increase.

 

Future minimum commitments under all non-cancelable leases required subsequent to December 31, 2012 are as follows:

 

(In thousands)

 

 

 

2013

 

$

3,443

 

2014

 

3,529

 

2015

 

3,617

 

2016

 

3,707

 

2017

 

3,800

 

Later years

 

22,194

 

 

 

$

40,290

 

 

Rent expense under these operating leases during the years ended December 31, 2012, 2011 and 2010 was $3.5 million, $1.1 million, and $1.1 million, respectively.

 

License Agreements

 

Under the Company’s Ampyra license agreement with Alkermes, the Company is obligated to make milestone payments to Alkermes of up to $15.0 million over the life of the contract and royalty payments as a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda. In addition, under the Company’s various other research, license and collaboration agreements with other parties, it is obligated to make milestone payments of up to an aggregate of approximately $192 million over the life of the contracts. The FDA approval of Ampyra triggered a milestone of $2.5 million to Alkermes that was paid during the quarter ended June 30, 2010. An additional milestone payment to Alkermes was paid during the quarter ended March 31, 2012 with an additional $2.5 million recorded as an intangible asset.  Further milestone amounts are payable in connection with additional indications.

 

Under the Company’s Ampyra supply agreement with Alkermes, payments for product manufactured by Alkermes are calculated as a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda. Under this agreement, Acorda also has the option to purchase an agreed to quantity of product from a second source provided Acorda makes a compensating payment to Alkermes for the quantities of product provided by the second source.

 

Under the Company’s license agreement with Rush-Presbyterian-St. Luke’s Medical Center, it is obligated to make royalty payments as a percentage of net sales in the United States and in countries other than the United States.

 

Under the Company’s supply agreement with Alkermes, it provides Alkermes with monthly written 18-month forecasts, and with annual written five-year forecasts for its supply requirements of Ampyra and two-year forecasts for its 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 the Company is obligated to purchase the quantity specified in the forecast, even if its actual requirements are greater or less.

 

Employment Agreements

 

The Company has an employment agreement with its Chief Executive Officer under which the Chief Executive Officer is entitled to severance and other payments if his employment is terminated under certain circumstances. The employment agreement was amended in 2011.  Under the employment agreement as amended, if the Company terminates the Chief Executive Officer for reasons other than cause or if the Chief Executive Officer terminates his employment for good reason, the Company must pay (i) an amount equal to the base salary the chief executive officer would have received during the 24 month period immediately following the date of termination, plus (ii) bonus equal to the Chief Executive Officer’s last annual bonus, prorated based on the number of days in the calendar year elapsed as of the termination date.  If the termination occurs after a change in control, then the bonus is an amount equal to two (2) times the larger of the Chief Executive Officer’s (x) prior year annual bonus and (y) target annual bonus for the year of termination.  The Chief Executive Officer is also entitled to COBRA premium payments for the 24 month severance period.

 

The Company also has employment agreements with some of its other executive officers, including the Company’s Chief Scientific Officer, Chief, Strategic Development and General Counsel and Chief Financial Officer, that govern the terms and conditions of their employment.  These agreements were amended during 2011.  Under these agreements as amended, if the Company terminates the employment of any of the executive officers for reasons other than cause, or if any of the executive officers terminates his or her employment for good reason, the Company must (i) make severance payments equal to the base salary the executive would have received during the twelve month period immediately following the date of termination, plus (ii) a bonus equal to the executive officer’s target cash bonus for the year of termination, prorated based on the number of days in the calendar year elapsed as of the termination date.  If the termination occurs within 18 months after a change in control, then the severance payment is 24 months of base salary and is paid in a lump sum, and the bonus is an amount equal to two (2) times the executive officer’s target cash bonus for the year of termination.  The executive officers are also entitled to COBRA premium payments for the relevant severance period.

 

The Company also has a change in control agreement with its Chief Medical Officer.  Under this agreement, if the Company terminates the employment of the Chief Medical Officer for reasons other than cause within twelve months following a change in control, or if the Chief Medical Officer terminates his employment for good reason within six months following a change in control, the Company must pay the Chief Medical Officer (i) a lump sum equal to the base salary the Chief Medical Officer would have received during the 24 month period immediately following the date of termination, plus (ii) a bonus equal to two times the Chief Medical Officer’s target cash bonus for the year of termination.  The Chief Medical Officer is also entitled to COBRA premium payments for the severance period.

 

Other

 

In August 2012, the Company received a letter from PRF alleging that it breached specified covenants and representations in the PRF agreement and purporting to exercise the put option.  The letter also includes an allegation that PRF has suffered injuries beyond what is covered by their purported exercise of the put option, although it does not specify or quantify those injuries.  The Company believes that the allegations are without merit and that the put option has not been validly exercised. Although the letter from PRF does not include a purported calculation of the put option price, if it were validly exercised, the Company estimates that the incremental cost in excess of amounts already accrued to PRF at December 31, 2012 would be no more than approximately $2.5 million.

 

On December 2, 2011, Apotex filed suit against the Company in the U.S. District Court for the Southern District of New York.  In that suit, Apotex alleged, among other claims, that the Company engaged in anticompetitive behavior and false advertising in connection with the development and marketing of Zanaflex Capsules, including that the citizen petition the Company filed with the FDA delayed FDA approval of Apotex’s generic tizanidine capsules.  On January 26, 2012, the Company moved to dismiss or stay Apotex’s suit.  On February 3, 2012, the FDA denied the citizen petition that the Company filed and approved Apotex’s ANDA for a generic version of Zanaflex Capsules.  On February 21, 2012, Apotex filed an amended complaint that incorporated the FDA action, but otherwise made allegations similar to the original complaint.  Requested judicial remedies include monetary damages, disgorgement of profits, recovery of litigation costs, and injunctive relief.  Following the Company’s filing of a motion to dismiss the amended complaint, in 2013 the Court dismissed six of the seven counts in the amended complaint, including all of the antitrust claims in the amended complaint, leaving only a claim under the Lanham Act relating to alleged product promotional activities. The Company has filed a motion for reconsideration of the decision regarding the Lanham Act claim. The Company intends to defend itself vigorously in the litigation.  However, the Company cannot be sure that it will prevail in its defense, as the outcome of litigation is inherently uncertain, and an adverse determination could harm it.

 

The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. While losses, if any, are possible the Company is not able to estimate any ranges of losses as of December 31, 2012. Litigation expenses are expensed as incurred.

Intangible Assets
Intangible Assets

(12) Intangible Assets

 

Zanaflex

 

The Company acquired all of Alkermes’ U.S. sales, marketing and distribution rights to Zanaflex Capsules and Zanaflex tablets in July 2004 for $2.0 million plus $675,000 for finished goods inventory. The Company was also responsible for up to $19.5 million in future contingent milestone payments based on cumulative gross sales of Zanaflex tablets and Zanaflex Capsules. As of December 31, 2009, the Company made $19.5 million of these milestone payments which were recorded as intangible assets in the consolidated financial statements.

 

The Company had sued Apotex Corp. and Apotex Inc. (collectively, “Apotex”) for patent infringement related to Apotex Inc.’s submission of an ANDA to the FDA seeking marketing approval for generic versions of Zanaflex Capsules.  In September 2011, the the U.S. District Court for the District of New Jersey ruled against the Company in that litigation. The Court held that the claims of U.S. Patent No. 6,455,557 covering use of multiparticulate tizanidine compositions are invalid as not enabled and not infringed by Apotex.  In June 2012, the U.S. Court of Appeals for the Federal Circuit affirmed the decision.  We did not seek any further appeals of the decision.  The Company believes that the intangible asset associated with Zanaflex Capsules was fully impaired based on estimated undiscounted cash flows and the associated fair value of this asset and therefore the Company recorded an asset impairment charge of approximately $13.0 million to write-off the remaining carrying value of this asset during the three-month period ended September 30, 2011 to cost of sales.

 

Ampyra

 

On January 22, 2010, the Company received marketing approval from the FDA for Ampyra triggering two milestone payments of $2.5 million to Alkermes, $750,000 to Rush-Presbyterian St. Luke’s Medical Center (Rush) and an additional $2.5 million payable to Alkermes two years from date of approval.  The Company made milestone payments totaling $3.25 million which were recorded as intangible assets in the consolidated financial statements during the three-month period ended March 31, 2010. An additional milestone payment to Alkermes was paid during the three-month period ended March 31, 2012 with an additional $2.5 million recorded as an intangible asset.

 

In April 2011 the Company announced the United States Patent and Trademark Office (USPTO) allowed U.S. Patent Application No. 11/010,828 entitled “Sustained Release Aminopyridine Composition.”  The claims of the patent application relate to methods to improve walking in patients with multiple sclerosis (MS) by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. The patent that issued from this application was accorded an initial patent term adjustment by the USPTO of 298 days, initially extending its term to early October 2025.  In August 2011 the USPTO issued the Company’s Patent Application No. 11/010,828 as U.S. Patent No. US 8,007,826 entitled “Sustained Release Aminopyridine Composition.”   The patent, which is listed in the FDA Orange Book, expires in May 2027. The estimated remaining useful life of this asset is presented in the table below.

 

In August 2003, the Company entered into an Amended and Restated License Agreement with the Canadian Spinal Research Organization (CSRO). Under this agreement, the Company was granted an exclusive and worldwide license under certain patent assets and know-how of CSRO relating to the use of dalfampridine in the reduction of chronic pain and spasticity in a spinal cord injured subject.  The agreement required the Company to pay to CSRO royalties based on a percentage of net sales of any product incorporating the licensed rights, including royalties on the sale of Ampyra and on the sale of dalfampridine for any other indication. During the three-month period ended March 31, 2010, the Company purchased CSRO’s rights to all royalty payments under the agreement with CSRO for $3.0 million.  This payment was recorded as an intangible asset in the consolidated financial statements. The estimated remaining useful life of this asset is presented in the table below.

 

Websites

 

Intangible assets also include certain website development costs which have been capitalized. The Company has developed several websites, each with its own purpose, including the general corporate website, product information websites and websites focused on the MS community.  In June 2012 the Company received an untitled letter from the FDA stating that one of its Ampyra promotional videos did not comply with applicable law and was misleading because it overstated the efficacy of and minimized important safety information associated with Ampyra.  In compliance with the untitled FDA letter, the Company discontinued use of the video, and in light of the FDA letter we also evaluated and discontinued the use of some other promotional materials.  Much of the promotional material was available on one of the Company’s websites and, as a result of its compliance with the FDA, portions of its website were permanently impaired. A charge of approximately $664,000 was recorded for this impairment and was recorded in selling, general and administrative expenses.

 

The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its intangible assets may warrant revision or that the carrying value of these assets may be impaired. As of December 31, 2012, the Company does not believe that there are any facts or circumstances that would indicate a need for changing the estimated remaining useful life of the Company’s other intangible assets.

 

Intangible assets consisted of the following:

 

(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

 

 

 

 

The Company recorded $2.6 million and $16.2 million in amortization expense related to these intangible assets in the years ended December 31, 2012 and 2011, respectively.  The expense recorded in 2012 includes a $664,000 charge for a website impairment charge relating to the removal of promotional materials as requested by the FDA recorded during the three-month period ended December 31, 2012.  The expense recorded in 2011 includes $13.0 million for Zanaflex Capsule intangible asset impairment recorded during the three-month period ended September 30, 2011 due to the trial court decision of the Apotex patent infringement lawsuit.

 

Estimated future amortization expense for intangible assets subsequent to December 31, 2012 for the next five years is as follows:

 

(In thousands)

 

 

 

2013

 

$

1,826

 

2014

 

1,573

 

2015

 

1,368

 

2016

 

588

 

2017

 

588

 

 

 

$

5,943

 

Debt
Debt

(13) Debt

 

Convertible Note

 

The Company is a party to an amended and restated license agreement and a supply agreement with Alkermes, which replaced two prior license and supply agreements for Ampyra.  Under the license agreement, Alkermes also loaned to the Company an aggregate of $7.5 million pursuant to two convertible promissory notes. On December 23, 2005, Alkermes transferred these promissory notes to funds affiliated with Saints Capital. One promissory note remains outstanding in the amount of $5.0 million bears interest at a rate of 3% beginning on the first anniversary of the issuance of the note (See Note 9).

 

Sale of Revenue Interest

 

On December 23, 2005, the Company entered into an agreement with an affiliate of Paul Royalty Fund (PRF), under which the Company received $15 million in cash. In exchange the Company has assigned PRF revenue interest in Zanaflex Capsules, Zanaflex tablets and any future Zanaflex products. The agreement covers all Zanaflex net revenues (as defined in the agreement) generated from October 1, 2005 through and including December 31, 2015, unless the agreement terminates earlier. In November 2006, the Company entered into an amendment to the revenue interest assignment agreement with PRF. Under the terms of the amendment, PRF paid the Company $5.0 million in November 2006. An additional $5.0 million was due to the Company if net revenues during the fiscal year 2006 equaled or exceeded $25.0 million. This milestone was met and the receivable was reflected in the Company’s December 31, 2006 financial statements. Under the terms of the amendment, the Company repaid PRF $5.0 million on December 1, 2009 and an additional $5.0 million on December 1, 2010 since the net revenues milestone was met. Under the agreement and the amendment to the agreement, PRF is entitled to the following portion of Zanaflex net revenues:

 

·                  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.

 

Notwithstanding the foregoing, once PRF has received and retained payments under the amended agreement that are at least 2.1 times the aggregate amount PRF has paid the Company under the agreement, PRF will only be entitled to 1% of Zanaflex net revenues. If PRF is entitled to 15% of net revenues as described above, the Company will remit 8% of cash payments received from wholesalers to PRF on a daily basis, with a quarterly reconciliation and settlement.

 

In connection with the transaction, the Company recorded a liability, referred to as the revenue interest liability. The Company imputes interest expense associated with this liability using the effective interest rate method and records a corresponding accrued interest liability. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of Zanaflex sales. The Company currently estimates that the imputed interest rate associated with this liability will be approximately 5.7%. Payments made to PRF as a result of Zanaflex sales levels will reduce the accrued interest liability and the principal amount of the revenue interest liability. The Company recorded approximately $1.7 million, $3.4 million and $3.8 million in interest expense related to this agreement in 2012, 2011 and 2010, respectively. Through December 31, 2012, $45.7 million in payments have been made to PRF as a result of Zanaflex sales levels and milestones reached.

 

The agreement also contains put and call options whereby the Company may repurchase the revenue interest at its option or can be required by PRF to repurchase the revenue interest, contingent upon certain events. If the Company experiences a change of control, undergoes certain bankruptcy events, transfers any of their interests in Zanaflex (other than pursuant to a license agreement, development, commercialization, co-promotion, collaboration, partnering or similar agreement), transfers all or substantially all of its assets, or breaches certain of the covenants, representations or warranties made under the agreement, PRF has the right, which the Company refers to as PRF’s put option, to require the Company to repurchase the rights sold to PRF at the “put/call price” in effect on the date such right is exercised. If the Company experiences a change of control it has the right, which the Company refers to as the Company’s call option, to repurchase the rights sold to PRF at the “put/call price” in effect on the date such right is exercised. If the Company’s call option becomes exercisable as a result of this trigger, the Company will have a period of 180 days during which to exercise the option. The Company does not currently intend to exercise its call option if it becomes exercisable as a result of such a transaction but may reevaluate whether it would exercise the option during the 180-day period. The put/call price on a given date is the greater of (i) 150% of all payments made by PRF as of such date, less all payments received by PRF as of such date, and (ii) an amount that would generate an internal rate of return to PRF of 25% on all payments made by PRF as of such date, taking into account the amount and timing of all payments received by PRF as of such date. The Company has determined that PRF’s put option and the Company’s call option meet the criteria to be considered an embedded derivative and should be accounted for as such. The Company recorded a net liability of $329,000 as of December 31, 2012 related to the put/call option to reflect its current estimated fair value. This liability is revalued as needed to reflect any changes in the fair value and any gain or loss resulting from the revaluation is recorded in earnings. For the year ended December 31, 2012, a gain of $701,000 has been recorded as a result of the change in the fair value of the net put/call liability balance from December 31, 2011.

Fair Value Measurements
Fair Value Measurements

(14) Fair Value Measurements

 

The Company defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the market in which the reporting entity transacts. The Company bases fair value on the assumptions market participants would use when pricing the asset or liability.

 

The Company utilizes a fair value hierarchy which requires it to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company primarily applies the market approach for recurring fair value measurements. The standard describes three levels of inputs that may be used to measure fair value:

 

·                  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.

 

Recurring

 

The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2012, and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. During the three-month period ended June 30, 2012 the Company reclassified its US Treasury bonds in short-term and long-term investments from Level 1 to Level 2 assets.

 

(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

 

 

The following table presents additional information about assets and/or liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value.

 

(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

 

 

The Company estimates the fair value of its put/call liability using a discounted cash flow valuation technique. Using this approach, historical and expected future cash flows are calculated over the expected life of the PRF agreement, are discounted, and then exercise scenario probabilities are applied. Some of the more significant assumptions made in the valuation include (i) the estimated Zanaflex revenue forecast and (ii) the likelihood of put/call exercise trigger events such as bankruptcy and change of control. The valuation is performed periodically when the significant assumptions change.  Realized gains and losses are included in sales, general and administrative expenses.

 

The put/call liability has been classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market due to the lack of trading in the security. If different assumptions were used for the various inputs to the valuation approach including, but not limited to, assumptions involving the estimated Zanaflex revenue forecast and the likelihood of trigger events, the estimated fair value could be significantly higher or lower than the fair value we determined. The Company may be required to record losses in future periods, which may be significant.

 

Assets Measured and Recorded at Fair Value on a Nonrecurring Basis

 

Our non-financial assets, such as intangible assets and property, plant and equipment are only recorded at fair value if an impairment charge is recognized. The tables below present non-financial assets that were measured and recorded at fair value on a nonrecurring basis and the total impairment losses recorded during 2012 and 2011.

 

 

 

Net Carrying Value as of
December 31,

 

Fair Value Measured and Recorded Using

 

Impairment
Losses
December 31,

 

(in thousands)

 

2012

 

Level 1

 

Level 2

 

Level 3

 

2012

 

Websites

 

$2,292

 

$2,292

 

$—

 

$—

 

$664

 

 

 

 

 

 

 

 

 

 

 

 

 

Total impairment losses

 

 

 

 

 

 

 

 

 

$664

 

 

 

 

Net Carrying Value as of
December 31,

 

Fair Value Measured and Recorded Using

 

Impairment
Losses
December 31,

 

(in thousands)

 

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.

 

Intangible assets also include certain website development costs which have been capitalized. The Company has developed several websites, each with its own purpose, including the general corporate website, product information websites and websites focused on the MS community.   In June 2012 the Company received an untitled letter from the FDA stating that one of its Ampyra promotional videos did not comply with applicable law and was misleading because it overstated the efficacy of and minimized important safety information associated with Ampyra.  In compliance with the untitled FDA letter, the Company discontinued use of the video, and in light of the FDA letter we also evaluated and discontinued the use of some other promotional materials.  Much of the promotional material was available on one of the Company’s websites and, as a result of its compliance with the FDA request, portions of our website were permanently impaired. A charge of approximately $664,000 was recorded for this impairment.

 

The Company had sued Apotex Corp. and Apotex Inc. (collectively, “Apotex”) for patent infringement related to Apotex Inc.’s submission of an ANDA to the FDA seeking marketing approval for generic versions of Zanaflex Capsules.  On September 7, 2011, the Company announced that the U.S. District Court for the District of New Jersey had ruled against it in that litigation. The Court held that the claims of U.S. Patent No. 6,455,557 covering use of multiparticulate tizanidine compositions are invalid as not enabled and not infringed by Apotex.   Following the Company’s appeal, in June 2012 the U.S. Court of Appeals for the Federal Circuit affirmed the decision.  The Company did not seek any further appeal of the decision.  The Company believes that the intangible asset associated with Zanaflex Capsules was fully impaired based on estimated undiscounted cash flows and the associated fair value of this asset and therefore the Company recorded an asset impairment charge of approximately $13.0 million to write-off the remaining carrying value of this asset during the three-month period ended September 30, 2011. See Note 12.

 

The Company estimated the fair value of its Zanaflex intangible asset using judgment. Based on what a market participant would pay, the Company made the significant assumption that since the Apotex trial court decision ruled that the underlying Zanaflex patent was invalid as not enabled, there is no market to sell the intangible asset and that the fair value is zero. The realized loss is included in cost of sales. This has been classified as a Level 3 asset as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market due to the lack of trading in the security. If different assumptions were used, the estimated fair value of these investments could be significantly higher than the fair value we determined.

Quarterly Consolidated Financial Data (unaudited)
Quarterly Consolidated Financial Data (unaudited)

(15) Quarterly Consolidated Financial Data (unaudited)

 

(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

 

Summary of Significant Accounting Policies (Policies)

Principles of Consolidation

 

The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America and include the results of operations of the Company and its majority owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

 

The preparation of the consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include share-based compensation accounting, which are largely dependent on the fair value of the Company’s equity securities. In addition, the Company recognizes Zanaflex revenue based on estimated prescriptions filled. The Company adjusts its Zanaflex inventory value based on an estimate of inventory that may be returned. Actual results could differ from those estimates.

Cash and Cash Equivalents

 

The Company considers all highly liquid debt instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund and US Treasury bonds, which are unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature.

Restricted Cash

 

Restricted cash represents a certificate of deposit placed by the Company with a bank for issuance of a letter of credit to the Company’s lessor for office space and a bank account with funds to cover its self-funded employee health insurance.

Investments

 

Both short-term and long-term investments consist of US Treasury bonds. The Company classifies marketable securities available to fund current operations as short-term investments in current assets on its consolidated balance sheets. Marketable securities are classified as long-term investments in long-term assets on the consolidated balance sheets if the Company has the ability and intent to hold them and such holding period may be longer than one year. The Company classifies its short-term and long-term investments as available-for-sale. Available-for-sale securities are recorded at fair value of the investments based on quoted market prices.

 

Unrealized holding gains and losses on available-for-sale securities, which are determined to be temporary, are excluded from earnings and are reported as a separate component of accumulated other comprehensive income (loss).

 

Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective-interest method. Dividend and interest income are recognized when earned. Amortized premiums and discounts, dividend and interest income and realized gains and losses are included in interest income.

Inventory

 

Inventory is stated at the lower of cost or market value and includes amounts for Ampyra, Zanaflex tablet and Zanaflex Capsule inventories and is recorded at its net realizable value. Inventories consist of finished goods inventory. Cost is determined using the first-in, first-out method (FIFO) for all inventories. The Company adjusts its inventory value based on an estimate of inventory that may be returned or not sold based on sales projections and establishes reserves as necessary for obsolescence and excess inventory.

 

Ampyra

 

The cost of Ampyra inventory manufactured by Alkermes plc (Alkermes) is based on specified prices calculated as a percentage of net product sales of the product shipped by Alkermes to Acorda. In the event Alkermes does not manufacture the products, Alkermes is entitled to a compensating payment for the quantities of product provided by Patheon, the Company’s alternative manufacturer. This compensating payment is included in the Company’s inventory balances.

Property and Equipment

 

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on the straight-line basis over the estimated useful lives of the assets, which ranges from two to seven years. Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on the straight-line basis over the shorter of the useful lives of the assets or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred.

Intangible Assets

 

The Company has recorded intangible assets related to milestones for Ampyra and for certain website development costs. These intangible assets are amortized on a straight line basis over the period in which the Company expects to receive economic benefit and are reviewed for impairment when facts and circumstances indicate that the carrying value of the asset may not be recoverable. The determination of the expected life will be dependent upon the use and underlying characteristics of the intangible asset. In the Company’s evaluation of the intangible assets, it considers the term of the underlying asset life and the expected life of the related product line. If the carrying value is not recoverable, impairment is measured as the amount by which the carrying value exceeds its estimated fair value. Fair value is generally estimated based on either appraised value or other valuation techniques.

Impairment of Long-Lived Assets

 

The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Any write-downs are treated as permanent reductions in the carrying amount of the assets.

Patent Costs

 

Patent application and maintenance costs are expensed as incurred.

Research and Development

 

Research and development expenses include the costs associated with the Company’s internal research and development activities, including salaries and benefits, occupancy costs, and research and development conducted for it by third parties, such as contract research organizations (CROs), sponsored university-based research, clinical trials, contract manufacturing for its research and development programs, and regulatory expenses.  In addition, research and development expenses include the cost of clinical trial drug supply shipped to the Company’s clinical study vendors. For those studies that the Company administers itself, the Company accounts for its clinical study costs by estimating the patient cost per visit in each clinical trial and recognizes this cost as visits occur, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. For those studies for which the Company uses a CRO, the Company accounts for its clinical study costs according to the terms of the CRO contract. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. As actual costs become known to the Company, it adjusts the accrual; such changes in estimate may be a material change in its clinical study accrual, which could also materially affect its results of operations. All research and development costs are expensed as incurred except when accounting for nonrefundable advance payments for goods or services to be used in future research and development activities.  These payments are capitalized at the time of payment and expensed ratably over the period the research and development activity is performed.

Accounting for Income Taxes

 

The Company provides for income taxes in accordance with ASC Topic 740 (ASC 740). Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized.

 

In determining whether a tax position is effectively settled for the purpose of recognizing previously unrecognized tax benefits, a two-step process is utilized whereby the threshold for recognition is a more likely-than-not test that the tax position will be sustained upon examination and the tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement.

Revenue Recognition

 

Ampyra

 

Ampyra is available only through a network of specialty pharmacy providers that provide the medication to patients by mail; Kaiser Permanente (Kaiser), which distributes Ampyra to patients through a closed network of on-site pharmacies; and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate), which is the exclusive specialty pharmacy distributor for Ampyra to the U.S. Department of Veterans Affairs (VA). Ampyra is not available in retail pharmacies. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes product sales of Ampyra following shipment of product to a network of specialty pharmacy providers, Kaiser, and the specialty distributor to the VA. The specialty pharmacy providers, Kaiser, and the specialty distributor to the VA are contractually obligated to hold no more than an agreed number of days of inventory, ranging from between 10 to 30 days.

 

The Company’s net revenues represent total revenues less allowances for customer credits, including estimated rebates, discounts and returns. These allowances are recorded for cash consideration given by a vendor to a customer that is presumed to be a reduction of the selling prices of the vendor’s products or services and, therefore, are characterized as a reduction of revenue. At the time product is shipped to specialty pharmacies, Kaiser and the specialty distributor to the VA, an adjustment is recorded for estimated rebates, discounts and returns. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for rebates, discounts and returns are established based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products.  Product shipping and handling costs are included in cost of sales. Effective December 1, 2012, the Company no longer accepts returns of Ampyra with the exception of product damages that occur during shipping.

 

Zanaflex

 

The Company applies the revenue recognition guidance in Accounting Standards Codification (ASC) 605-15-25, which among other criteria requires that future returns can be reasonably estimated in order to recognize revenue. The amount of future tablet returns is uncertain due to generic competition and customer conversion to Zanaflex Capsules. The Company has accumulated some sales history with Zanaflex Capsules; however, due to existing and potential generic competition and customer conversion from Zanaflex tablets to Zanaflex Capsules, we do not believe we can reasonably determine a return rate at this time. As a result, the Company accounts for these product shipments using a deferred revenue recognition model. Under the deferred revenue model, the Company does not recognize revenue upon product shipment. For these product shipments, the Company invoices the wholesaler, records deferred revenue at gross invoice sales price, and classifies the cost basis of the product held by the wholesaler as a component of inventory. The Company recognizes revenue when prescribed to the end-user, on a first-in first-out (FIFO) basis. The Company’s revenue to be recognized is based on (1) the estimated prescription demand, based on pharmacy sales for its products; and (2) the Company’s analysis of third party information, including third party market research data. The Company’s estimates are subject to the inherent limitations of estimates that rely on third party data, as certain third party information is itself in the form of estimates, and reflect other limitations. The Company’s sales and revenue recognition reflects the Company’s estimates of actual product prescribed to the end-user. The Company expects to be able to apply a more traditional revenue recognition policy such that revenue is recognized following shipment to the customer when it believes it has sufficient data to develop reasonable estimates of expected returns based upon historical returns and greater certainty regarding generic competition.

 

The Company’s net revenues represent total revenues less allowances for customer credits, including estimated discounts, rebates, and chargebacks. These allowances are recorded for cash consideration given by a vendor to a customer that is presumed to be a reduction of the selling prices of the vendor’s products or services and, therefore, should be characterized as a reduction of revenue when recognized in the vendor’s statement of operations. Adjustments are recorded for estimated chargebacks, rebates, and discounts. These allowances are established by management as its best estimate based on available information and are adjusted to reflect known changes in the factors that impact such allowances. Allowances for chargebacks, rebates and discounts are established based on the contractual terms with customers, analysis of historical levels of discounts, chargebacks and rebates, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for each product and anticipated introduction of competitive products. In addition, the Company records a charge to cost of goods sold for the cost basis of the estimated product returns the Company believes may ultimately be realized at the time of product shipment to wholesalers. The Company has recognized this charge at the date of shipment since it is probable that it will receive a level of returned products; upon the return of such product it will be unable to resell the product considering its expiration dating; and it can reasonably estimate a range of returns. This charge represents the cost basis for the low end of the range of the Company’s estimated returns. Product shipping and handling costs are included in cost of sales.

 

Milestones and royalties

 

In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones using the criteria as provided by the Financial Accounting Standards Boards (FASB) guidance on the milestone method of revenue recognition. At the inception of a collaboration agreement the Company evaluates if payments are substantive.  The criteria requires that (i) the Company determines if the milestone is commensurate with either its performance to achieve the milestone or the enhancement of value resulting from the Company’s activities to achieve the milestone, (ii) the milestone be related to past performance, and (iii) the milestone be reasonably relative to all deliverable and payment terms of the collaboration arrangement.  If these criteria are met then the contingent milestones can be considered as substantive milestones and will be recognized as revenue in the period that the milestone is achieved. Royalties are recognized as earned in accordance with the terms of various research and collaboration agreements.

Collaborations

 

The Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it shall be accounted for as a separate element or single unit of accounting. If an element shall be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue shall be recognized. If an element shall not be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue shall be recognized. Payments received in excess of revenues recognized are recorded as deferred revenue until such time as the revenue recognition criteria have been met.

Concentration of Risk

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of investments in cash, cash equivalents, restricted cash and accounts receivable. The Company maintains cash, cash equivalents, restricted cash, short-term and long-term investments with approved financial institutions. The Company is exposed to credit risks and liquidity in the event of default by the financial institutions or issuers of investments in excess of FDIC insured limits. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any institution.

 

The Company does not own or operate, and currently does not plan to own or operate, facilities for production and packaging of Ampyra or its other commercial products, Zanaflex Capsules or Zanaflex tablets. It relies and expects to continue to rely on third parties for the production and packaging of its commercial products and clinical trial materials for those and other products.

 

The Company relies on Alkermes to supply us with its requirements for Ampyra.  Under its supply agreement with Alkermes, the Company is obligated to purchase at least 75% of its yearly supply of Ampyra from Alkermes, and it is required to make compensatory payments if it does not purchase 100% of its requirements from Alkermes, subject to specified certain exceptions. The Company and Alkermes have agreed that it may purchase up to 25% of its annual requirements from Patheon, a mutually agreed-upon second manufacturing source, with compensatory payment.  The Company and Alkermes also rely on a single third-party manufacturer, Regis, to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra.  If Regis experiences any disruption in their operations, a delay or interruption in the supply of Ampyra product could result until Regis cures the problem or we locate an alternate source of supply.

 

The Company’s principal direct customers as of December 31, 2012 were a network of specialty pharmacies, Kaiser, and the specialty distributor to the VA for Ampyra and wholesale pharmaceutical distributors for Zanaflex Capsules and Zanaflex tablets. The Company periodically assesses the financial strength of these customers and establishes allowances for anticipated losses, if necessary.

Allowance for Cash Discounts

 

An allowance for cash discounts is accrued based on historical usage rates at the time of product shipment.  The Company adjusts accruals based on actual activity as necessary.  Cash discounts are typically settled with customers within 30 days after the end of each calendar month.  The Company has cash discount allowances of $3.2 million and $3.4 million for the years ended December 31, 2012 and 2011, respectively.  The Company’s accruals for cash discount allowances were $293,000 and $303,000 as of December 31, 2012 and 2011, respectively.

Allowance for Doubtful Accounts

 

A portion of the Company’s accounts receivable may not be collected due principally to customer disputes and sales returns. The Company provides reserves for these situations based on the evaluation of the aging of its trade receivable portfolio and an analysis of high-risk customers. The Company has not historically experienced losses related to credit risk.  The Company has recognized an allowance related to one customer of approximately $260,000 and $600,000 as of December 31, 2012, and December 31, 2011, respectively.  For the year ended December 31, 2012, the Company recorded a provision of $60,000 and write-offs of $400,000.  For the year ended December 31, 2011, the Company recorded a provision of $600,000 and did not record any write-offs.

Contingencies

 

The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. Litigation expenses are expensed as incurred.

Fair Value of Financial Instruments

 

The fair value of a financial instrument represents the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. Significant differences can arise between the fair value and carrying amounts of financial instruments that are recognized at historical cost amounts. The Company considers that fair value should be based on the assumptions market participants would use when pricing the asset or liability.

 

The following methods are used to estimate the fair value of Company’s financial instruments:

 

(a)                                 Cash equivalents, grants receivables, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to the short-term nature of these instruments;

 

(b)                                 Available-for-sale securities are recorded based primarily on quoted market prices;

 

(c)                                  Put/call liability’s fair value is based on revenue projections and business, general economic and market conditions that could be reasonably evaluated as of the valuation date;

 

It is not practical for the Company to estimate the fair value of the convertible notes payable due to the specific provisions of these notes. The terms of these notes are disclosed at Note 9. See Note 14 for discussion on fair value measurements.

Earnings per Share

 

Basic net income (loss) per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method) and the vesting of restricted stock.  In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. Common equivalent shares have not been included in the net income (loss) per share calculations for the year ended 2010 because the effect of including them would have been anti-dilutive.   See Note 7 for discussion on earnings per share.

Share-based Compensation

 

The Company has various share-based employee and non-employee compensation plans, which are described more fully in Note 6.

 

The Company accounts for stock options and restricted stock granted to employees and non-employees by recognizing the costs resulting from all share-based payment transactions in the consolidated financial statements at their fair values. The Company estimates the fair value of each option on the date of grant using the Black-Scholes closed-form option-pricing model based on assumptions of expected volatility of its common stock, prevailing interest rates, an estimated forfeiture rate, and the expected term of the stock options, and we recognize that cost as an expense ratably over the associated employee service period.

Segment Information

 

The Company is managed and operated as one business. The entire business is managed by a single management team that reports to the chief executive officer. The Company does not operate separate lines of business with respect to any of its products or product candidates. Accordingly, the Company does not prepare discrete financial information with respect to separate products or product candidates or by location and does not have separately reportable segments.

Comprehensive Income

 

Unrealized gains (losses) from the Company’s investment securities are included in accumulated other comprehensive income (loss) within the consolidated balance sheet.

Recent Accounting Pronouncements

 

In June 2011, the FASB issued an accounting standards update regarding the presentation of comprehensive income in financial statements. The provisions of this standard provide an option to present the components of net income and other comprehensive income either as one continuous statement of comprehensive income or as two separate but consecutive statements. The Company reports components of comprehensive income in two separate consecutive statements in accordance with the Financial Accounting Standard Board’s amended guidance on the presentation of comprehensive income. The new guidance was effective for the Company January 1, 2012.

 

In May 2011, the FASB issued ASU No. 2011-04, “Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs” (ASU 2011-04). This newly issued accounting standard clarifies the application of certain existing fair value measurement guidance and expands the disclosures for fair value measurements that are estimated using significant unobservable (Level 3) inputs. The provisions of this new disclosure standard are effective January 1, 2012.  This accounting standard update did not have a material effect on the Company’s financial statements.

Subsequent Events

 

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were no subsequent events requiring disclosure in or requiring adjustment to these financial statements.

Investments (Tables)
Schedule of available-for-sale securities

 

(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

 

Property and Equipment (Tables)
Property and Equipment

 

 

(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

 

 

 

Accrued Expenses and Other Current Liabilities (Tables)
Accrued Expenses and Other Current Liabilities

 

(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

 

Common Stock Options and Restricted Stock (Tables)

 

 

 

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

%