ACORDA THERAPEUTICS INC, 10-Q filed on 5/10/2013
Quarterly Report
Document and Entity Information
3 Months Ended
Mar. 31, 2013
Apr. 30, 2013
Document and Entity Information
 
 
Entity Registrant Name
ACORDA THERAPEUTICS INC 
 
Entity Central Index Key
0001008848 
 
Document Type
10-Q 
 
Document Period End Date
Mar. 31, 2013 
 
Amendment Flag
false 
 
Current Fiscal Year End Date
--12-31 
 
Entity Current Reporting Status
Yes 
 
Entity Filer Category
Large Accelerated Filer 
 
Entity Common Stock, Shares Outstanding
 
40,566,088 
Document Fiscal Year Focus
2013 
 
Document Fiscal Period Focus
Q1 
 
Consolidated Balance Sheets (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Current assets:
 
 
Cash and cash equivalents
$ 34,687 
$ 41,876 
Restricted cash
34 
380 
Short-term investments
248,659 
191,949 
Trade accounts receivable, net of allowances of $587 and $555, as of March 31, 2013 and December 31, 2012, respectively
23,288 
26,327 
Prepaid expenses
7,606 
6,936 
Finished goods inventory held by the Company
27,850 
20,176 
Finished goods inventory held by others
736 
781 
Deferred tax asset
36,955 
35,091 
Other current assets
11,060 
9,547 
Total current assets
390,875 
333,063 
Long-term investments
41,559 
99,363 
Property and equipment, net of accumulated depreciation
16,936 
16,706 
Deferred tax asset
101,545 
101,636 
Intangible assets, net of accumulated amortization
9,446 
9,319 
Non-current portion of deferred cost of license revenue
4,649 
4,808 
Other assets
413 
437 
Total assets
565,423 
565,332 
Current liabilities:
 
 
Accounts payable
24,077 
22,503 
Accrued expenses and other current liabilities
31,786 
35,758 
Deferred product revenue-Zanaflex
29,620 
29,275 
Current portion of deferred license revenue
9,057 
9,057 
Current portion of revenue interest liability
1,180 
1,134 
Current portion of convertible notes payable
1,144 
1,144 
Total current liabilities
96,864 
98,871 
Non-current portion of deferred license revenue
66,421 
68,685 
Put/call liability
247 
329 
Non-current portion of revenue interest liability
891 
1,111 
Non-current portion of convertible notes payable
3,133 
4,244 
Other non-current liabilities
6,228 
6,171 
Commitments and contingencies
   
   
Stockholders' equity:
 
 
Common stock, $0.001 par value. Authorized 80,000,000 shares at March 31, 2013 and December 31, 2012; issued and outstanding 39,893,408 and 39,804,493 shares, including those held in treasury, as of March 31, 2013 and December 31, 2012, respectively
40 
40 
Treasury stock at cost (12,420 shares at March 31, 2013 and December 31, 2012)
(329)
(329)
Additional paid-in capital
647,507 
640,671 
Accumulated deficit
(255,662)
(254,523)
Accumulated other comprehensive income
83 
62 
Total stockholders' equity
391,639 
385,921 
Total liabilities and stockholders' equity
$ 565,423 
$ 565,332 
Consolidated Balance Sheets (Parenthetical) (USD $)
In Thousands, except Share data, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Consolidated Balance Sheets
 
 
Trade accounts receivable, allowances (in dollars)
$ 587 
$ 555 
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
39,893,408 
39,804,493 
Common stock, outstanding shares
39,893,408 
39,804,493 
Treasury stock, shares
12,420 
12,420 
Consolidated Statements of Operations (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Revenues:
 
 
Net product revenues
$ 64,084 
$ 65,673 
Royalty revenues
5,516 
3,310 
License revenue
2,265 
2,265 
Total net revenues
71,865 
71,248 
Costs and expenses:
 
 
Cost of sales
13,484 
12,464 
Cost of license revenue
159 
159 
Research and development
12,520 
11,025 
Selling, general and administrative
48,198 
38,745 
Total operating expenses
74,361 
62,393 
Operating (loss) income
(2,496)
8,855 
Other expense (net):
 
 
Interest and amortization of debt discount expense
(591)
(766)
Interest income
173 
129 
Total other expense (net)
(418)
(637)
(Loss) income before taxes
(2,914)
8,218 
Benefit from (provision for) income taxes
1,775 
(372)
Net (loss) income
$ (1,139)
$ 7,846 
Net (loss) income per share-basic (in dollars per share)
$ (0.03)
$ 0.20 
Net (loss) income per share-diluted (in dollars per share)
$ (0.03)
$ 0.19 
Weighted average common shares outstanding used in computing net (loss) income per share-basic (in shares)
39,832 
39,340 
Weighted average common shares outstanding used in computing net (loss) income per share-diluted (in shares)
39,832 
40,407 
Consolidated Statements of Comprehensive (Loss) Income (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Consolidated Statements of Comprehensive (Loss) Income
 
 
Net (loss) income
$ (1,139)
$ 7,846 
Other comprehensive income (loss):
 
 
Unrealized gains (losses) on available for sale securities, net of tax
21 
(100)
Other comprehensive income (loss), net of tax
21 
(100)
Comprehensive (loss) income
$ (1,118)
$ 7,746 
Consolidated Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Cash flows from operating activities:
 
 
Net (loss) income
$ (1,139)
$ 7,846 
Adjustments to reconcile net income to net cash provided by operating activities:
 
 
Share-based compensation expense
4,933 
4,191 
Amortization of net premiums and discounts on investments
586 
1,507 
Amortization of revenue interest issuance cost
16 
30 
Depreciation and amortization expense
1,400 
912 
Gain on put/call liability
(82)
(535)
Deferred tax benefit
(1,772)
 
Changes in assets and liabilities:
 
 
Decrease in accounts receivable
3,039 
1,302 
Increase in prepaid expenses and other current assets
(2,183)
(5,459)
Increase in inventory held by the Company
(7,674)
(357)
Decrease in inventory held by others
45 
81 
Decrease in non-current portion of deferred cost of license revenue
159 
159 
Decrease (increase) in other assets
(92)
Decrease in accounts payable, accrued expenses, other current liabilities
(3,510)
(6,144)
Increase in revenue interest liability interest payable
92 
421 
Decrease in non-current portion of deferred license revenue
(2,264)
(2,264)
Increase in other non-current liabilities
 
1,858 
Increase (decrease) in deferred product revenue-Zanaflex
345 
(444)
Decrease in restricted cash
346 
 
Net cash (used in) provided by operating activities
(7,655)
3,012 
Cash flows from investing activities:
 
 
Purchases of property and equipment
(1,060)
(3,104)
Purchases of intangible assets
(641)
(656)
Purchases of investments
(27,471)
(65,396)
Proceeds from maturities of investments
28,000 
61,750 
Net cash used in investing activities
(1,172)
(7,406)
Cash flows from financing activities:
 
 
Proceeds from issuance of common stock and option exercises
1,903 
1,949 
Repayments of revenue interest liability
(265)
(209)
Net cash provided by financing activities
1,638 
1,740 
Net decrease in cash and cash equivalents
(7,189)
(2,654)
Cash and cash equivalents at beginning of period
41,876 
57,954 
Cash and cash equivalents at end of period
34,687 
55,300 
Supplemental disclosure:
 
 
Cash paid for interest
466 
304 
Cash paid for taxes
$ 731 
$ 165 
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 unaudited interim consolidated financial statements and the related information included in the notes to the consolidated financial statements. In the opinion of management, the unaudited interim 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. Results of operations for interim periods are not necessarily indicative of the results to be expected for the entire year.

 

These unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company as of and for the year ended December 31, 2012 included in the Company’s Annual Report on Form 10-K for such year, as filed with the Securities and Exchange Commission (the “SEC”).

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.

 

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 is 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.

 

Accumulated Other Comprehensive Income

 

                The Company’s accumulated other comprehensive income is comprised of gains and losses on available for sale securities and is recorded and presented net of income tax.

 

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. Bureau of Prisons and 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 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 reasonable relative to all deliverable and payment terms of the collaboration arrangement.  If these criteria are met then the contingent milestones can be considered 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.

 

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.

 

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.

 

Recent Accounting Pronouncements

 

                In February 2013, the FASB amended its guidance to require an entity to present the effect of certain significant reclassifications out of accumulated other comprehensive income on the respective line items in net income. The new accounting guidance does not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income. The guidance is effective prospectively for fiscal years beginning after December 15, 2012.  The Company adopted these new provisions for the quarter beginning January 1, 2013. As the guidance requires additional presentation only, there was no impact to the Company’s consolidated results of operations or financial position.

 

Share-based Compensation
Share-based Compensation

(3) Share-based Compensation

 

During the three-month periods ended March 31, 2013 and 2012, the Company recognized share-based compensation expense of $4.9 million and $4.2 million, respectively. Activity in options and restricted stock during the three-month period ended March 31, 2013 and related balances outstanding as of that date are reflected below. The weighted average fair value per share of options granted to employees for the three-month periods ended March 31, 2013 and 2012 were approximately $15.41 and $14.15, respectively.

 

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

 

 

 

For the three-month

 

 

 

period ended March 31,

 

(In thousands)

 

2013

 

2012

 

Research and development

 

$

1,151

 

$

989

 

Selling, general and administrative

 

3,782

 

3,202

 

Total

 

$

4,933

 

$

4,191

 

 

A summary of share-based compensation activity for the three-month period ended March 31, 2013 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 January 1, 2013

 

5,667

 

$

22.30

 

 

 

 

 

Granted

 

1,315

 

30.29

 

 

 

 

 

Cancelled

 

(20

)

27.26

 

 

 

 

 

Exercised

 

(89

)

21.50

 

 

 

 

 

Balance at March 31, 2013

 

6,873

 

$

23.82

 

7.03

 

$

57,595

 

Vested and expected to vest at March 31, 2013

 

6,778

 

$

23.76

 

7.00

 

$

57,245

 

Vested and exercisable at March 31, 2013

 

3,785

 

$

20.66

 

5.38

 

$

43,903

 

 

Restricted Stock Activity

 

(In thousands)
Restricted Stock

 

Number of Shares

 

Nonvested at January 1, 2013

 

458

 

Granted

 

210

 

Vested

 

 

Forfeited

 

(1

)

Nonvested at March 31, 2013

 

667

 

 

Unrecognized compensation cost for unvested stock options and restricted stock awards as of March 31, 2013 totaled $56.8 million and is expected to be recognized over a weighted average period of approximately 2.9 years.

Earnings Per Share
Earnings Per Share

(4) Earnings Per Share

 

The following table sets forth the computation of basic and diluted earnings per share for the three-month periods ended March 31, 2013 and 2012:

 

(In thousands, except per share data)

 

Three-month
period ended
March 31, 2013

 

Three-month
period ended
March 31, 2012

 

Basic and diluted

 

 

 

 

 

Net (loss) income

 

$

(1,139

)

$

7,846

 

Weighted average common shares outstanding used in computing net (loss) income per share—basic

 

39,832

 

39,340

 

Plus: net effect of dilutive stock options and restricted common shares

 

 

1,067

 

Weighted average common shares outstanding used in computing net (loss) income per share—diluted

 

39,832

 

40,407

 

Net (loss) income per share—basic

 

$

(0.03

)

$

0.20

 

Net (loss) income per share—diluted

 

$

(0.03

)

$

0.19

 

 

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 (loss) income per diluted share because their effects were anti-dilutive:

 

(In thousands)

 

Three-month
period ended
March 31, 2013

 

Three-month
period ended
March 31, 2012

 

Denominator

 

 

 

 

 

Stock options and restricted common shares

 

7,540

 

5,189

 

Convertible note

 

39

 

48

 

Income Taxes
Income Taxes

(5) Income Taxes

 

             For the three-month periods ended March 31, 2013 and 2012, the Company recorded a $1.8 million benefit from and a $372,000 provision for income taxes, respectively, based upon its estimated tax liability for the year. The benefit / provision for income taxes is based on federal, state and Puerto Rico income taxes. The effective income tax rates for the Company for the three-month periods ended March 31, 2013 and 2012 were (60.9)% and 4.5%, respectively. The effective tax rate for the three-month period ended March 31, 2013 benefited from the Company's loss during the three-month period ending March 31, 2013. In addition, as a result of the January 2013 extension of the Federal research and development tax credit retroactive to January 2012 the Company recorded a benefit of $1.2 million for the estimated 2012 credit. During the three-month period ended March 31, 2013 the Company also settled an IRS examination of their corporate income tax returns for years ending December 31, 2009 through December 31, 2011.  The impact of the settlement partially offset the benefit recorded for the research and development tax credit.

 

                The Company continues to evaluate the realizability of its deferred tax assets and liabilities on a periodic basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets in the future would impact the Company's income taxes.

Fair Value Measurements
Fair Value Measurements

(6) Fair Value Measurements

 

The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of March 31, 2013 and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices, interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability. The Company’s Level 1 assets consist of time deposits and investments in a Treasury money market fund and the Company’s Level 2 assets consist of high-quality government bonds and are valued using market prices on the active markets.  Level 1 instrument valuations are obtained from real-time quotes for transactions in active exchange markets involving identical assets and Level 2 assets are valued using quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates and yield curves. The Company’s Level 3 liability represents our put/call liability related to the Paul Royalty Fund (PRF) transaction. No changes in valuation techniques or inputs occurred during the three months ended March 31, 2013.

 

(In thousands)

 

Level 1

 

Level 2

 

Level 3

 

March 31, 2013

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

Cash equivalents

 

$

16,294

 

$

 

$

 

Short-term investments

 

 

248,659

 

 

Long-term investments

 

 

41,559

 

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

Put/call liability

 

 

 

247

 

December 31, 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

 

 

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)

 

Three-month
period ended
March 31, 2013

 

Three-month
period ended
March 31, 2012

 

Put/call liability:

 

 

 

 

 

Balance, beginning of period

 

$

329

 

$

1,030

 

Total realized and unrealized gains included in selling, general and administrative expenses:

 

(82

)

(535

)

Balance, end of period

 

$

247

 

$

495

 

 

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 selling, 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.

Investments
Investments

(7) 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

 

March 31, 2013

 

 

 

 

 

 

 

 

 

US Treasury bonds

 

$

290,081

 

$

137

 

$

 

$

290,218

 

December 31, 2012

 

 

 

 

 

 

 

 

 

US Treasury bonds

 

291,209

 

104

 

(1

)

291,312

 

 

The contractual maturities of short-term available-for-sale debt securities at March 31, 2013 and December 31, 2012 are greater than 3 months but less than 1 year. The contractual and intended maturities of long-term available-for-sale debt securities at March 31, 2013 and December 31, 2012 are greater than 1 year and up to 15 months. The Company has determined that there were no other-than-temporary declines in the fair values of its investments as of March 31, 2013.

 

Short-term investments with maturity of three months or less from date of purchase have been classified as cash equivalents, and amounted to $16.3 million and $27.9 million as of March 31, 2013 and December 31, 2012, respectively.

 

The Company holds available-for-sale investment securities which are reported at fair value on the Company’s balance sheet. Unrealized holding gains and losses are reported within accumulated other comprehensive income (AOCI) in the statements of comprehensive (loss) income.  The changes in AOCI associated with the unrealized holding gain on available-for-sale investments during the three months ended March 31, 2013, were as follows (in thousands):

 

(In thousands)

 

Net Unrealized
Gains (Losses) on
Marketable
Securities

 

Total

 

Balance at December 31, 2012

 

$

62

 

$

62

 

Other comprehensive income before reclassifications:

 

21

 

21

 

Amounts reclassified from accumulated other comprehensive income

 

 

 

Net current period other comprehensive income

 

21

 

21

 

Balance at March 31, 2013

 

$

83

 

$

83

 

Collaborations, Alliances, and Other Agreements
Collaborations, Alliances, and Other Agreements

(8) Collaborations, Alliances, and Other Agreements

 

Biogen

 

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 $2.3 million in license revenue, a portion of the $110.0 million received from Biogen Idec, and $159,000 in cost of license revenue, a portion of the $7.7 million paid to Alkermes, during the three-month periods ended March 31, 2013 and 2012.

 

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 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 March 31, 2012. 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 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 March 31, 2012.

 

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 three-month periods ended March 31, 2013 and 2012, the Company recognized royalty revenue of $2.6 million and $1.5 million, respectively, related to the gross margin of the Zanaflex Capsule authorized generic.  During the three-month periods ended March 31, 2013 and 2012, the Company also recognized revenue and a corresponding cost of sales of $493,000 and $1.1 million, respectively, 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.

Commitments and Contingencies
Commitments and Contingencies

(9) Commitments and Contingencies

 

 

A summary of the Company’s commitments and contingencies was included in the Company’s Annual Report on Form 10-K for the twelve-month period ended December 31, 2012. The Company’s long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business.

 

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 March 31, 2013. Litigation expenses are expensed as incurred.

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.

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 is 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.

Accumulated Other Comprehensive Income

 

                The Company’s accumulated other comprehensive income is comprised of gains and losses on available for sale securities and is recorded and presented net of income tax.

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. Bureau of Prisons and 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 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 reasonable relative to all deliverable and payment terms of the collaboration arrangement.  If these criteria are met then the contingent milestones can be considered 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.

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.

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.

Recent Accounting Pronouncements

 

                In February 2013, the FASB amended its guidance to require an entity to present the effect of certain significant reclassifications out of accumulated other comprehensive income on the respective line items in net income. The new accounting guidance does not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income. The guidance is effective prospectively for fiscal years beginning after December 15, 2012.  The Company adopted these new provisions for the quarter beginning January 1, 2013. As the guidance requires additional presentation only, there was no impact to the Company’s consolidated results of operations or financial position.

Share-based Compensation (Tables)

 

 

 

 

For the three-month

 

 

 

period ended March 31,

 

(In thousands)

 

2013

 

2012

 

Research and development

 

$

1,151

 

$

989

 

Selling, general and administrative

 

3,782

 

3,202

 

Total

 

$

4,933

 

$

4,191

 

 

 

 

 

Number of Shares
(In thousands)

 

Weighted Average
Exercise Price

 

Weighted Average
Remaining
Contractual
Term

 

Intrinsic Value
(In thousands)

 

Balance at January 1, 2013

 

5,667

 

$

22.30

 

 

 

 

 

Granted

 

1,315

 

30.29

 

 

 

 

 

Cancelled

 

(20

)

27.26

 

 

 

 

 

Exercised

 

(89

)

21.50

 

 

 

 

 

Balance at March 31, 2013

 

6,873

 

$

23.82

 

7.03

 

$

57,595

 

Vested and expected to vest at March 31, 2013

 

6,778

 

$

23.76

 

7.00

 

$

57,245

 

Vested and exercisable at March 31, 2013

 

3,785

 

$

20.66

 

5.38

 

$

43,903

 

 

 

(In thousands)
Restricted Stock

 

Number of Shares

 

Nonvested at January 1, 2013

 

458

 

Granted

 

210

 

Vested

 

 

Forfeited

 

(1

)

Nonvested at March 31, 2013

 

667

 

Earnings Per Share (Tables)

 

 

(In thousands, except per share data)

 

Three-month
period ended
March 31, 2013

 

Three-month
period ended
March 31, 2012

 

Basic and diluted

 

 

 

 

 

Net (loss) income

 

$

(1,139

)

$

7,846

 

Weighted average common shares outstanding used in computing net (loss) income per share—basic

 

39,832

 

39,340

 

Plus: net effect of dilutive stock options and restricted common shares

 

 

1,067

 

Weighted average common shares outstanding used in computing net (loss) income per share—diluted

 

39,832

 

40,407

 

Net (loss) income per share—basic

 

$

(0.03

)

$

0.20

 

Net (loss) income per share—diluted

 

$

(0.03

)

$

0.19

 

 

 

(In thousands)

 

Three-month
period ended
March 31, 2013

 

Three-month
period ended
March 31, 2012

 

Denominator

 

 

 

 

 

Stock options and restricted common shares

 

7,540

 

5,189

 

Convertible note

 

39

 

48

 

Fair Value Measurements (Tables)

 

 

(In thousands)

 

Level 1

 

Level 2

 

Level 3

 

March 31, 2013

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

Cash equivalents

 

$

16,294

 

$

 

$

 

Short-term investments

 

 

248,659

 

 

Long-term investments

 

 

41,559

 

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

Put/call liability

 

 

 

247

 

December 31, 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

 

 

 

(In thousands)

 

Three-month
period ended
March 31, 2013

 

Three-month
period ended
March 31, 2012

 

Put/call liability:

 

 

 

 

 

Balance, beginning of period

 

$

329

 

$

1,030

 

Total realized and unrealized gains included in selling, general and administrative expenses:

 

(82

)

(535

)

Balance, end of period

 

$

247

 

$

495

 

Investments (Tables)

 

 

(In thousands)

 

Amortized
Cost

 

Gross
unrealized
gains

 

Gross
unrealized
losses

 

Estimated
fair
value

 

March 31, 2013

 

 

 

 

 

 

 

 

 

US Treasury bonds

 

$

290,081

 

$

137

 

$

 

$

290,218

 

December 31, 2012

 

 

 

 

 

 

 

 

 

US Treasury bonds

 

291,209

 

104

 

(1

)

291,312

 

 

 

(In thousands)

 

Net Unrealized
Gains (Losses) on
Marketable
Securities

 

Total

 

Balance at December 31, 2012

 

$

62

 

$

62

 

Other comprehensive income before reclassifications:

 

21

 

21

 

Amounts reclassified from accumulated other comprehensive income

 

 

 

Net current period other comprehensive income

 

21

 

21

 

Balance at March 31, 2013

 

$

83

 

$

83

 

Summary of Significant Accounting Policies (Details) (Ampyra)
3 Months Ended
Mar. 31, 2013
Minimum
 
Revenue Recognition
 
Contractually obligated inventory holdings period
10 days 
Maximum
 
Revenue Recognition
 
Contractually obligated inventory holdings period
30 days 
Summary of Significant Accounting Policies (Details 2)
3 Months Ended
Mar. 31, 2013
item
Segment Information
 
Number of businesses in operation
Share-based Compensation (Details) (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Share-based compensation expense
 
 
Share-based compensation expense recognized
$ 4,933 
$ 4,191 
Weighted average fair value of options granted to employees (in dollars per share)
$ 15.41 
$ 14.15 
Research and development
 
 
Share-based compensation expense
 
 
Share-based compensation expense recognized
1,151 
989 
Selling, general, and administrative
 
 
Share-based compensation expense
 
 
Share-based compensation expense recognized
$ 3,782 
$ 3,202 
Share-based Compensation (Details 2) (USD $)
Share data in Thousands, except Per Share data, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Share based compensation, other disclosures
 
Total unrecognized compensation costs related to unvested options and restricted stock awards that the company expects to recognize
$ 56,800,000 
Weighted average period
2 years 10 months 24 days 
Stock Options
 
Stock Option Activity
 
Beginning balance (in shares)
5,667 
Granted (in shares)
1,315 
Cancelled (in shares)
(20)
Exercised (in shares)
(89)
Ending balance (in shares)
6,873 
Vested and expected to vest at end of period (in shares)
6,778 
Vested and exercisable at end of period (in shares)
3,785 
Weighted Average Exercise Price
 
Balance at the beginning of the period (in dollars per share)
$ 22.30 
Granted (in dollars per share)
$ 30.29 
Cancelled (in dollars per share)
$ 27.26 
Exercised (in dollars per share)
$ 21.50 
Balance at the end of the period (in dollars per share)
$ 23.82 
Vested and expected to vest at the end of the period (in dollars per share)
$ 23.76 
Vested and exercisable at the end of the period (in dollars per share)
$ 20.66 
Weighted Average Remaining Contractual Term
 
Balance at the end of the period
7 years 11 days 
Vested and expected to vest at the end of the period
7 years 
Vested and exercisable at the end of the period
5 years 4 months 17 days 
Intrinsic Value
 
Balance at the end of the period
57,595,000 
Vested and expected to vest at the end of the period
57,245,000 
Vested and exercisable at the end of the period
$ 43,903,000 
Restricted Stock
 
Restricted Stock Activity
 
Nonvested at the beginning of the period (in shares)
458 
Granted (in shares)
210 
Forfeited (in shares)
(1)
Nonvested at the end of the period (in shares)
667 
Earnings Per Share (Details) (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Basic and diluted
 
 
Net (loss) income
$ (1,139)
$ 7,846 
Weighted average common shares outstanding used in computing net (loss) income per share-basic
39,832 
39,340 
Plus: net effect of dilutive stock options and restricted common shares
 
1,067 
Weighted average common shares outstanding used in computing net (loss) income per share-diluted
39,832 
40,407 
Net (loss) income per share-basic (in dollars per share)
$ (0.03)
$ 0.20 
Net (loss) income per share-diluted (in dollars per share)
$ (0.03)
$ 0.19 
Earnings Per Share (Details 2)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Stock options and restricted common shares
 
 
Antidilutive Securities
 
 
Anti-dilutive securities excluded from computation of earnings per share
7,540 
5,189 
Convertible note
 
 
Antidilutive Securities
 
 
Anti-dilutive securities excluded from computation of earnings per share
39 
48 
Income Taxes (Details) (USD $)
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Income Taxes
 
 
Income tax benefit (provision)
$ 1,775,000 
$ (372,000)
Effective income tax rate (as a percent)
(60.90%)
4.50% 
Tax credit
$ 1,200,000 
 
Fair Value Measurements (Details) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Assets Carried at Fair Value:
 
 
Short-term investments
$ 248,659 
$ 191,949 
Long-term investments
41,559 
99,363 
Recurring basis |
Level 1
 
 
Assets Carried at Fair Value:
 
 
Cash equivalents
16,294 
27,932 
Recurring basis |
Level 2
 
 
Assets Carried at Fair Value:
 
 
Short-term investments
248,659 
191,949 
Long-term investments
41,559 
99,363 
Recurring basis |
Level 3
 
 
Liabilities Carried at Fair Value:
 
 
Put/call liability
$ 247 
$ 329 
Fair Value Measurements (Details 2) (Put/call liability, USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Put/call liability
 
 
Put/call liability
 
 
Balance, beginning of period
$ 329 
$ 1,030 
Total realized and unrealized gains included in selling, general and administrative expenses:
(82)
(535)
Balance, end of period
$ 247 
$ 495 
Investments (Details) (USD $)
3 Months Ended
Mar. 31, 2013
Dec. 31, 2012
Investments
 
 
Short-term investments classified as cash and cash equivalents
$ 16,300,000 
$ 27,900,000 
Other-than-temporary declines in the fair values of investments
 
Minimum
 
 
Investments
 
 
Short-term investments maturity term
3 months 
 
Long-term investments maturity term
1 year 
 
Maximum
 
 
Investments
 
 
Short-term investments maturity term
1 year 
 
Long-term investments maturity term
15 months 
 
US Treasury bonds
 
 
Investments
 
 
Amortized Cost
290,081,000 
291,209,000 
Gross unrealized gains
137,000 
104,000 
Gross unrealized losses
 
(1,000)
Estimated fair value
$ 290,218,000 
$ 291,312,000 
Investments (Details 2) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Changes in accumulated other comprehensive income
 
 
Balance at the beginning of the period
$ 62 
 
Other comprehensive income before reclassifications
21 
 
Other comprehensive income (loss), net of tax
21 
(100)
Balance at the end of the period
83 
 
Net Unrealized Gain (Loss) on Marketable Securities
 
 
Changes in accumulated other comprehensive income
 
 
Balance at the beginning of the period
62 
 
Other comprehensive income before reclassifications
21 
 
Other comprehensive income (loss), net of tax
21 
 
Balance at the end of the period
$ 83 
 
Collaborations, Alliances, and Other Agreements (Details) (USD $)
3 Months Ended 0 Months Ended 3 Months Ended 3 Months Ended 1 Months Ended 3 Months Ended 12 Months Ended 3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Jun. 30, 2009
Biogen Idec
Mar. 31, 2013
Biogen Idec
Mar. 31, 2012
Biogen Idec
Jul. 7, 2009
Biogen Idec
Jul. 1, 2009
Biogen Idec
Jun. 30, 2009
Biogen Idec
Maximum
Mar. 31, 2013
Actavis/Watson
Mar. 31, 2012
Actavis/Watson
Dec. 31, 2012
Neuronex
Feb. 29, 2012
Neuronex
DZNS
Mar. 31, 2013
Neuronex
DZNS
Dec. 31, 2012
Neuronex
DZNS
Mar. 31, 2013
Neuronex
DZNS
Maximum
Mar. 31, 2013
Neuronex
DZNS
SK
Maximum
Collaboration agreement
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deferred license revenue
 
 
$ 110,000,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cash received
 
 
 
 
 
 
110,000,000 
 
 
 
 
 
 
 
 
 
Milestone payment due upon approval of the product in the European Union
 
 
 
 
25,000,000 
 
 
 
 
 
 
 
 
 
 
 
Additional payments based on the successful achievement of future regulatory milestones
 
 
 
 
 
 
 
10,000,000 
 
 
 
 
 
 
 
 
Contingent receivable based on the successful achievement of future sales milestones
 
 
 
 
 
 
 
365,000,000 
 
 
 
 
 
 
 
 
Payment made to third party for cost of license
 
 
 
 
 
7,700,000 
 
 
 
 
 
 
 
 
 
 
Amount of significant and incremental discount related to the supply agreement
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Identified non-contingent deliverables value on standalone basis, if sold separately
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
License Revenue
 
 
 
2,300,000 
2,300,000 
 
 
 
 
 
 
 
 
 
 
 
Cost of license revenue
 
 
 
159,000 
159,000 
 
 
 
 
 
 
 
 
 
 
 
Current estimate of license revenue recognition period
 
 
12 years 
 
 
 
 
 
 
 
 
 
 
 
 
 
Portion of milestone payment from Acorda to Alkermes (as a percent)
 
 
 
 
7.00% 
 
 
 
 
 
 
 
 
 
 
 
Royalty revenues
5,516,000 
3,310,000 
 
 
 
 
 
 
2,600,000 
1,500,000 
 
 
 
 
 
 
Revenue recognized
64,084,000 
65,673,000 
 
 
 
 
 
 
493,000 
1,100,000 
 
 
 
 
 
 
Cost of sales
13,484,000 
12,464,000 
 
 
 
 
 
 
493,000 
1,100,000 
 
 
 
 
 
 
Business Acquisition
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Upfront payments recorded as research and development expense
 
 
 
 
 
 
 
 
 
 
 
2,000,000 
 
 
 
 
Advance research funding payments recorded as research and development expense
 
 
 
 
 
 
 
 
 
 
 
 
 
1,500,000 
 
 
Payments to complete the acquisition
 
 
 
 
 
 
 
 
 
 
6,800,000 
 
 
 
 
 
Tangible net assets acquired, primarily the taxable amount of net operating loss carryforwards
 
 
 
 
 
 
 
 
 
 
3,700,000 
 
 
 
 
 
Additional payments upon successful achievement of future regulatory and manufacturing-related milestones
 
 
 
 
 
 
 
 
 
 
 
 
 
 
18,000,000 
 
Additional payments upon successful achievement of future sales milestones
 
 
 
 
 
 
 
 
 
 
 
 
 
 
105,000,000 
 
Royalty payment period
 
 
 
 
 
 
 
 
 
 
 
 
10 years 
 
 
 
Payments Neuronex is obligated to make to SK upon achievement of specified development milestones
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8,000,000 
Entitlement of additional payments based on the successful achievement of future sales milestones
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3,000,000 
Holdback provision
 
 
 
 
 
 
 
 
 
 
$ 300,000