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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Acorda Therapeutics Inc | NASDAQ:ACOR | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.661 | 0.565 | 0.5878 | 0 | 01:00:00 |
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended June 30, 2016
|
|
OR
|
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from to
|
|
Commission File Number 000-50513
|
Delaware
(State or other jurisdiction of incorporation
or organization)
|
13-3831168
(I.R.S. Employer Identification No.) |
420 Saw Mill River Road, Ardsley, New York
(Address of principal executive offices) |
10502
(Zip Code) |
Large accelerated filer
☒
|
Accelerated filer
☐
|
Non-accelerated filer
☐
(Do not check if a smaller reporting company) |
Smaller Reporting Company
☐
|
Class
|
Outstanding at July 29, 2016
|
|
Common Stock, $0.001 par value
per share |
46,139,900 shares
|
Page
|
||
PART I—FINANCIAL INFORMATION
|
||
Item 1.
|
Financial Statements
|
1
|
Consolidated Balance Sheets as of June 30, 2016 (unaudited) and December 31, 2015
|
1
|
|
Consolidated Statements of Operations (unaudited) for the Three and Six-month Periods Ended June 30, 2016 and 2015
|
2
|
|
Consolidated Statements of Comprehensive (Loss) Income (unaudited) for the Three and Six-month Periods Ended June 30, 2016 and 2015
|
3
|
|
Consolidated Statements of Cash Flows (unaudited) for the Six-month Periods Ended June 30, 2016 and 2015
|
4
|
|
Notes to Consolidated Financial Statements (unaudited)
|
5
|
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
19
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
35
|
Item 4.
|
Controls and Procedures
|
36
|
PART II—OTHER INFORMATION
|
||
Item 1.
|
Legal Proceedings
|
37
|
Item 1A.
|
Risk Factors
|
39
|
Item 6.
|
Exhibits
|
40
|
(In thousands, except share data)
|
June 30, 2016
|
December 31,
2015 |
||||||
(unaudited)
|
||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
137,400
|
$
|
153,204
|
||||
Restricted cash
|
—
|
6,032
|
||||||
Short-term investments
|
—
|
200,101
|
||||||
Trade accounts receivable, net of allowances of $985 and $884, as of June 30, 2016 and December 31, 2015, respectively
|
45,886
|
31,466
|
||||||
Prepaid expenses
|
18,709
|
16,079
|
||||||
Finished goods inventory
|
55,553
|
36,476
|
||||||
Other current assets
|
5,616
|
7,959
|
||||||
Total current assets
|
263,164
|
451,317
|
||||||
Property and equipment, net of accumulated depreciation
|
36,754
|
40,204
|
||||||
Goodwill
|
284,504
|
183,636
|
||||||
Deferred tax asset
|
2,128
|
2,128
|
||||||
Intangible assets, net of accumulated amortization
|
751,524
|
430,856
|
||||||
Non-current portion of deferred cost of license revenue
|
2,589
|
2,906
|
||||||
Other assets
|
5,876
|
247
|
||||||
Total assets
|
$
|
1,346,539
|
$
|
1,111,294
|
||||
Liabilities and Stockholders' Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
29,554
|
$
|
14,233
|
||||
Accrued expenses and other current liabilities
|
96,388
|
66,158
|
||||||
Current portion of deferred license revenue
|
9,057
|
9,057
|
||||||
Current portion of convertible notes payable
|
1,126
|
1,144
|
||||||
Total current liabilities
|
136,125
|
90,592
|
||||||
Convertible senior notes (due 2021)
|
294,854
|
290,420
|
||||||
Acquired contingent consideration
|
71,700
|
63,500
|
||||||
Non-current portion of deferred license revenue
|
36,984
|
41,513
|
||||||
Non-current portion of convertible notes payable
|
—
|
1,107
|
||||||
Deferred tax liability
|
89,960
|
12,146
|
||||||
Other non-current liabilities
|
35,374
|
8,991
|
||||||
Commitments and contingencies
|
||||||||
Stockholders' equity:
|
||||||||
Common stock, $0.001 par value. Authorized 80,000,000 shares at June 30, 2016 and December 31, 2015; issued 46,103,367 and 43,440,324 shares, including those held in treasury, as of June 30, 2016 and December 31, 2015, respectively
|
46
|
43
|
||||||
Treasury stock at cost (12,420 shares at June 30, 2016 and December 31, 2015)
|
(329
|
)
|
(329
|
)
|
||||
Additional paid-in capital
|
904,784
|
812,782
|
||||||
Accumulated deficit
|
(228,152
|
)
|
(209,352
|
)
|
||||
Accumulated other comprehensive loss
|
(4,711
|
)
|
(119
|
)
|
||||
Total stockholders' equity - Acorda Therapeutics, Inc.
|
671,638
|
603,025
|
||||||
Noncontrolling interest
|
9,904
|
—
|
||||||
Total stockholders' equity
|
681,542
|
603,025
|
||||||
Total liabilities and stockholders' equity
|
$
|
1,346,539
|
$
|
1,111,294
|
(In thousands, except per share data)
|
Three-month
period ended June 30, 2016 |
Three-month
period ended June 30, 2015 |
Six-month
period ended June 30, 2016 |
Six-month
period ended June 30, 2015 |
||||||||||||
Revenues:
|
||||||||||||||||
Net product revenues
|
$
|
120,695
|
$
|
107,565
|
$
|
230,842
|
$
|
201,064
|
||||||||
Royalty revenues
|
4,499
|
3,878
|
7,990
|
7,966
|
||||||||||||
License revenue
|
2,264
|
2,264
|
4,529
|
4,529
|
||||||||||||
Total net revenues
|
127,458
|
113,707
|
243,361
|
213,559
|
||||||||||||
Costs and expenses:
|
||||||||||||||||
Cost of sales
|
26,435
|
22,708
|
49,621
|
41,155
|
||||||||||||
Cost of license revenue
|
159
|
159
|
317
|
317
|
||||||||||||
Research and development
|
50,293
|
31,229
|
94,863
|
61,865
|
||||||||||||
Selling, general and administrative
|
62,604
|
52,819
|
121,584
|
101,589
|
||||||||||||
Changes in fair value of acquired contingent consideration
|
2,000
|
1,100
|
8,200
|
4,200
|
||||||||||||
Total operating expenses
|
141,491
|
108,015
|
274,585
|
209,126
|
||||||||||||
Operating (loss) income
|
(14,033
|
)
|
5,692
|
(31,224
|
)
|
4,433
|
||||||||||
Other (expense) income (net):
|
||||||||||||||||
Interest and amortization of debt discount expense
|
(4,033
|
)
|
(4,010
|
)
|
(7,757
|
)
|
(8,061
|
)
|
||||||||
Interest income
|
48
|
94
|
263
|
160
|
||||||||||||
Realized loss on foreign currency transactions
|
(1,486
|
)
|
—
|
(1,495
|
)
|
—
|
||||||||||
Other (expense) income
|
(425
|
)
|
351
|
10,026
|
471
|
|||||||||||
Total other (expense) income (net)
|
(5,896
|
)
|
(3,565
|
)
|
1,037
|
(7,430
|
)
|
|||||||||
(Loss) income before taxes
|
(19,929
|
)
|
2,127
|
(30,187
|
)
|
(2,997
|
)
|
|||||||||
Benefit from (Provision for) income taxes
|
972
|
(1,130
|
)
|
10,709
|
909
|
|||||||||||
Net (loss) income
|
$
|
(18,957
|
)
|
$
|
997
|
$
|
(19,478
|
)
|
$
|
(2,088
|
)
|
|||||
Net loss attributable to non-controlling interest
|
678
|
—
|
678
|
—
|
||||||||||||
Net (loss) income attributable to Acorda Therapeutics, Inc.
|
$
|
(18,279
|
)
|
$
|
997
|
$
|
(18,800
|
)
|
$
|
(2,088
|
)
|
|||||
Net (loss) income per share attributable to Acorda Therapeutics, Inc.—basic
|
$
|
(0.40
|
)
|
$
|
0.02
|
$
|
(0.42
|
)
|
$
|
(0.05
|
)
|
|||||
Net (loss) income per share attributable to Acorda Therapeutics, Inc.—diluted
|
$
|
(0.40
|
)
|
$
|
0.02
|
$
|
(0.42
|
)
|
$
|
(0.05
|
)
|
|||||
Weighted average common shares outstanding used in computing net (loss) income per share attributable to Acorda Therapeutics, Inc.—basic
|
45,338
|
42,085
|
45,077
|
42,058
|
||||||||||||
Weighted average common shares outstanding used in computing net (loss) income per share attributable to Acorda Therapeutics, Inc.—diluted
|
45,338
|
43,282
|
45,077
|
42,058
|
(In thousands)
|
Three-month
period ended June 30, 2016 |
Three-month
period ended June 30, 2015 |
Six-month
period ended June 30, 2016 |
Six-month
period ended June 30, 2015 |
||||||||||||
Net (loss) income
|
$
|
(18,957
|
)
|
$
|
997
|
$
|
(19,478
|
)
|
$
|
(2,088
|
)
|
|||||
Other comprehensive (loss) income, net of tax:
|
||||||||||||||||
Foreign currency translation adjustment
|
(4,711
|
)
|
—
|
(4,711
|
)
|
—
|
||||||||||
Unrealized gains on available for sale securities
|
—
|
31
|
—
|
14
|
||||||||||||
Reclassification of net losses to net income
|
—
|
—
|
119
|
—
|
||||||||||||
Other comprehensive (loss) income, net of tax
|
(4,711
|
)
|
31
|
(4,592
|
)
|
14
|
||||||||||
Comprehensive (loss) income
|
$
|
(23,668
|
)
|
$
|
1,028
|
$
|
(24,070
|
)
|
$
|
(2,074
|
)
|
|||||
Other comprehensive (loss) attributable to noncontrolling interest
|
$
|
(128
|
)
|
$
|
—
|
$
|
(128
|
)
|
$
|
—
|
(In thousands)
|
Six-month
period ended June 30, 2016 |
Six-month
period ended June 30, 2015 |
||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(19,478
|
)
|
$
|
(2,088
|
)
|
||
Adjustments to reconcile net (loss) to net cash used in operating activities:
|
||||||||
Share‑based compensation expense
|
17,432
|
15,834
|
||||||
Amortization of net premiums and discounts on investments
|
467
|
1,434
|
||||||
Amortization of debt discount and debt issuance costs
|
4,564
|
4,230
|
||||||
Amortization of revenue interest issuance cost
|
—
|
7
|
||||||
Depreciation and amortization expense
|
9,916
|
7,491
|
||||||
Change in acquired contingent consideration obligation
|
8,200
|
4,200
|
||||||
Realized gain on foreign currency transaction
|
(10,484
|
)
|
—
|
|||||
Deferred tax benefit
|
(11,116
|
)
|
(909
|
)
|
||||
Changes in assets and liabilities:
|
||||||||
(Increase) decrease in accounts receivable
|
(14,328
|
)
|
2,413
|
|||||
Decrease (increase) in prepaid expenses and other current assets
|
1,996
|
(3,845
|
)
|
|||||
Increase in inventory
|
(19,077
|
)
|
(22,366
|
)
|
||||
Decrease in non-current portion of deferred cost of license revenue
|
317
|
317
|
||||||
Decrease in other assets
|
17
|
17
|
||||||
Increase (decrease) in accounts payable, accrued expenses, other current liabilities
|
27,217
|
(2,496
|
)
|
|||||
Decrease in revenue interest liability interest payable
|
—
|
(190
|
)
|
|||||
Decrease in non-current portion of deferred license revenue
|
(4,528
|
)
|
(4,528
|
)
|
||||
Decrease in deferred product revenue—Zanaflex
|
—
|
(1,017
|
)
|
|||||
Decrease (increase) in restricted cash
|
6,032
|
(4,504
|
)
|
|||||
Net cash used in operating activities
|
(2,853
|
)
|
(6,000
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
(2,504
|
)
|
(4,057
|
)
|
||||
Purchases of intangible assets
|
(388
|
)
|
(572
|
)
|
||||
Acquisitions, net of cash received
|
(275,100
|
)
|
—
|
|||||
Purchases of investments
|
(40,221
|
)
|
(275,987
|
)
|
||||
Proceeds from maturities of investments
|
246,966
|
174,500
|
||||||
Net cash used in investing activities
|
(71,247
|
)
|
(106,116
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of common stock and option exercises
|
74,051
|
6,268
|
||||||
Purchase of noncontrolling interest
|
(14,489
|
)
|
—
|
|||||
Debt issuance costs
|
(1,479
|
)
|
—
|
|||||
Repayments of revenue interest liability
|
(41
|
)
|
(125
|
)
|
||||
Net cash provided by financing activities
|
58,042
|
6,143
|
||||||
Effect of exchange rate changes on cash and cash equivalents
|
254
|
—
|
||||||
Net decrease in cash and cash equivalents
|
(15,804
|
)
|
(105,973
|
)
|
||||
Cash and cash equivalents at beginning of period
|
153,204
|
182,170
|
||||||
Cash and cash equivalents at end of period
|
$
|
137,400
|
$
|
76,197
|
||||
Supplemental disclosure:
|
||||||||
Cash paid for interest
|
3,040
|
3,986
|
||||||
Cash paid for taxes
|
2,578
|
1,323
|
||||||
As of and for the Period Ended
|
|||
Exchange rates
|
June 30, 2016
|
||
Period end EUR: USD exchange rate
|
1.11
|
||
Average period EUR: USD exchange rate
|
1.13
|
(In thousands)
|
Balance at December 31, 2015
|
|||||||
Revised Reporting
|
As Previously Reported
|
|||||||
Other assets
|
$
|
247
|
$
|
5,296
|
||||
Convertible notes payable – due 2021
|
$
|
(290,420
|
)
|
$
|
(295,469
|
)
|
(In thousands)
Cash and cash equivalents
|
$
|
73,854
|
||
Other current assets
|
2,208
|
|||
Other long-term assets
|
4,962
|
|||
Intangible assets (indefinite-lived)
|
260,500
|
|||
Intangible assets (definite-lived)
|
65,000
|
|||
Current liabilities
|
(17,547
|
)
|
||
Deferred taxes
|
(89,038
|
)
|
||
Other long-term liabilities
|
(26,715
|
)
|
||
Fair value of assets and liabilities acquired
|
273,224
|
|||
Goodwill
|
102,676
|
|||
Total purchase price
|
375,900
|
|||
Less: Noncontrolling interests
|
(25,736
|
)
|
||
Purchase consideration on date of acquisition
|
$
|
350,164
|
(In thousands)
|
Stockholders'
Equity
Acorda
|
Non-Controlling
Interest
|
Total Stockholders'
Equity
|
|||||||||
Balance at December 31, 2015
|
$
|
603,025
|
$
|
—
|
$
|
603,025
|
||||||
Net loss
|
(18,800
|
)
|
(678
|
)
|
(19,478
|
)
|
||||||
Other comprehensive loss
|
(4,592
|
)
|
(128
|
)
|
(4,720
|
)
|
||||||
Noncontrolling interest at date of acquisition
|
—
|
25,736
|
25,736
|
|||||||||
Purchase of noncontrolling interest
|
537
|
(15,026
|
)
|
(14,489
|
)
|
|||||||
Private Placement, net of issuance costs
|
72,094
|
—
|
72,094
|
|||||||||
Stock compensation expense and option exercises
|
19,374
|
—
|
19,374
|
|||||||||
Balance at June 30, 2016
|
$
|
671,638
|
$
|
9,904
|
$
|
681,542
|
Three-month
|
Six-month
|
|||||||||||||||
period ended
|
period ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
(In thousands)
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Revenues
|
$
|
127,675
|
$
|
115,178
|
$
|
244,419
|
$
|
216,016
|
||||||||
Loss from continuing operations attributable to Acorda
|
$
|
(25,085
|
)
|
$
|
(11,058
|
)
|
$
|
(43,177
|
)
|
$
|
(22,996
|
)
|
June 30, 2016
|
December 31, 2015
|
||||||||||||||||||||||||||||||
(Dollars In thousands)
|
Estimated
Remaining
Useful Lives
(Years)
|
Cost
|
Accumulated
Amortization |
Foreign
Currency
Translation
|
Net
Carrying
Amount
|
Cost
|
Accumulated
Amortization |
Net
Carrying
Amount |
|||||||||||||||||||||||
In-process research & development (1)
|
Indefinite-lived
|
$
|
683,500
|
$
|
-
|
$
|
(586
|
)
|
$
|
682,914
|
$
|
423,000
|
$
|
-
|
$
|
423,000
|
|||||||||||||||
Selincro
|
7
|
65,000
|
(1,935
|
)
|
(1,115
|
)
|
61,950
|
-
|
-
|
-
|
|||||||||||||||||||||
Ampyra milestones
|
11
|
5,750
|
(2,529
|
)
|
-
|
3,221
|
5,750
|
(2,380
|
)
|
3,370
|
|||||||||||||||||||||
Ampyra CSRO royalty buyout
|
4
|
3,000
|
(1,962
|
)
|
-
|
1,038
|
3,000
|
(1,817
|
)
|
1,183
|
|||||||||||||||||||||
Website development costs
|
3
|
12,705
|
(10,657
|
)
|
-
|
2,048
|
12,504
|
(9,467
|
)
|
3,037
|
|||||||||||||||||||||
Website development costs – in process
|
n/a
|
|
353
|
-
|
-
|
353
|
266
|
-
|
266
|
||||||||||||||||||||||
$
|
770,308
|
$
|
(17,083
|
)
|
$
|
(1,701
|
)
|
$
|
751,524
|
$
|
444,520
|
$
|
(13,664
|
)
|
$
|
430,856
|
(1)
|
Includes the fair values of: CVT-301: $423.0 million; tozadenant: $232.0 million; SYN-120: $24.2 million and BTT-1023: $4.3 million
|
(In thousands)
|
||||
2016
|
$
|
5,640
|
||
2017
|
10,868
|
|||
2018
|
10,172
|
|||
2019
|
9,924
|
|||
2020
|
9,602
|
|||
Thereafter
|
23,166
|
|||
$
|
69,372
|
In thousands
Balance at December 31, 2015
|
$
|
183,636
|
||
Goodwill associated with the acquisition of Biotie Therapies
|
102,676
|
|||
Foreign currency translation adjustment
|
(1,808
|
)
|
||
Balance at June 30, 2016
|
$
|
284,504
|
For the three-month
|
For the six-month
|
|||||||||||||||
period ended June 30,
|
period ended June 30,
|
|||||||||||||||
(In millions)
|
2016
|
2015
|
2016
|
2015
|
||||||||||||
Research and development
|
$
|
2.6
|
$
|
2.2
|
$
|
4.7
|
$
|
4.0
|
||||||||
Selling, general and administrative
|
6.7
|
6.5
|
12.7
|
11.8
|
||||||||||||
Total
|
$
|
9.3
|
$
|
8.7
|
$
|
17.4
|
$
|
15.8
|
Number of Shares
(In thousands)
|
Weighted Average
Exercise Price |
Weighted Average
Remaining Contractual Term |
Intrinsic Value
(In thousands)
|
|||||||||||||
Balance at January 1, 2016
|
8,223
|
$
|
30.97
|
|||||||||||||
Granted
|
1,555
|
32.55
|
||||||||||||||
Cancelled
|
(256
|
)
|
35.37
|
|||||||||||||
Exercised
|
(111
|
)
|
17.67
|
|||||||||||||
Balance at June 30, 2016
|
9,411
|
$
|
31.27
|
6.7
|
$
|
6,766
|
||||||||||
Vested and expected to vest at June 30, 2016
|
9,295
|
$
|
31.24
|
6.7
|
$
|
6,765
|
||||||||||
Vested and exercisable at June 30, 2016
|
5,724
|
$
|
29.40
|
5.3
|
$
|
6,755
|
(In thousands)
Restricted Stock
|
Number of Shares
|
|||
Nonvested at January 1, 2016
|
441
|
|||
Granted
|
609
|
|||
Vested
|
(18
|
)
|
||
Forfeited
|
(179
|
)
|
||
Nonvested at June 30, 2016
|
853
|
(In thousands, except per share data)
|
Three-month
period ended June 30, 2016 |
Three-month
period ended June 30, 2015 |
Six-month
period ended June 30, 2016 |
Six-month
period ended June 30, 2015 |
||||||||||||
Basic and diluted
|
||||||||||||||||
Net (loss) income
|
$
|
(18,279
|
)
|
$
|
997
|
$
|
(18,800
|
)
|
$
|
(2,088
|
)
|
|||||
Weighted average common shares outstanding used in computing net (loss) income per share—basic
|
45,338
|
42,085
|
45,077
|
42,058
|
||||||||||||
Plus: net effect of dilutive stock options and restricted common shares
|
—
|
1,197
|
—
|
—
|
||||||||||||
Weighted average common shares outstanding used in computing net (loss) income per share—diluted
|
45,338
|
43,282
|
45,077
|
42,058
|
||||||||||||
Net (loss) income per share—basic
|
$
|
(0.40
|
)
|
$
|
0.02
|
$
|
(0.42
|
)
|
$
|
(0.05
|
)
|
|||||
Net (loss) income per share—diluted
|
$
|
(0.40
|
)
|
$
|
0.02
|
$
|
(0.42
|
)
|
$
|
(0.05
|
)
|
(In thousands)
|
Three-month
period ended
June 30, 2016
|
Three-month
period ended
June 30, 2015
|
Six-month
period ended
June 30, 2016
|
Six-month
period ended
June 30, 2015
|
||||||||||||
Denominator
|
||||||||||||||||
Stock options and restricted common shares
|
7,502
|
5,406
|
7,536
|
3,974
|
||||||||||||
Convertible note – Saints Capital
|
10
|
19
|
10
|
19
|
(In thousands)
|
Level 1
|
Level 2
|
Level 3
|
|||||||||
June 30, 2016
|
||||||||||||
Assets Carried at Fair Value:
|
||||||||||||
Cash equivalents
|
$
|
28,976
|
$
|
—
|
$
|
—
|
||||||
Liabilities Carried at Fair Value:
|
||||||||||||
Acquired contingent consideration
|
—
|
—
|
71,700
|
|||||||||
December 31, 2015
|
||||||||||||
Assets Carried at Fair Value:
|
||||||||||||
Cash equivalents
|
$
|
70,504
|
$
|
13,009
|
$
|
—
|
||||||
Short-term investments
|
—
|
200,101
|
—
|
|||||||||
Liabilities Carried at Fair Value:
|
||||||||||||
Acquired contingent consideration
|
—
|
—
|
63,500
|
(In thousands)
|
Three-month
period ended June 30, 2016 |
Three-month
period ended June 30, 2015 |
Six-month
period ended June 30, 2016 |
Six-month
period ended June 30, 2015 |
||||||||||||
Acquired contingent consideration:
|
||||||||||||||||
Balance, beginning of period
|
$
|
69,700
|
$
|
55,700
|
$
|
63,500
|
$
|
52,600
|
||||||||
Fair value change to contingent consideration (unrealized) included in the statement of operations
|
2,000
|
1,100
|
8,200
|
4,200
|
||||||||||||
Balance, end of period
|
$
|
71,700
|
$
|
56,800
|
$
|
71,700
|
$
|
56,800
|
(In thousands)
|
Amortized
Cost |
Gross
unrealized gains |
Gross
unrealized losses |
Estimated
fair value |
||||||||||||
June 30, 2016
|
||||||||||||||||
U.S. Treasury bonds
|
$
|
—
|
$
|
—
|
$
|
(—
|
)
|
$
|
—
|
|||||||
December 31, 2015
|
||||||||||||||||
U.S. Treasury bonds
|
200,244
|
—
|
(143
|
)
|
200,101
|
(In thousands)
|
Net Unrealized Gains (Losses) on Marketable Securities
|
|||
Balance at December 31, 2015
|
$
|
(119
|
)
|
|
Other comprehensive loss before reclassifications:
|
—
|
|||
Amounts reclassified from accumulated other
comprehensive loss
|
119
|
|||
Net current period other comprehensive income
|
119
|
|||
Balance at June 30, 2016
|
$
|
—
|
·
|
U.S. accounts receivable, inventory and manufacturing equipment;
|
·
|
Equity interests in the Company's U.S. subsidiaries (other than its U.S. subsidiary of Biotie Therapies Oyj) and up to 65% of the voting equity interests of its directly owned foreign subsidiaries; and
|
·
|
Substantially all other tangible and intangible assets, including equipment, contract rights and intellectual property (other than intellectual property related to Ampyra).
|
Payments due by period (1)(9)
|
|||||||||||||||
(In thousands)
|
Total
|
Less than
1 year |
1-3 years
|
4-5 years
|
|||||||||||
Convertible Senior Notes (2)
|
$
|
374,575
|
$
|
6,038
|
$
|
12,075
|
$
|
356,462
|
|||||||
Convertible note payable (3)
|
1,144
|
1,144
|
—
|
—
|
|||||||||||
Capital loans (4) (6)
|
19,987
|
—
|
—
|
—
|
|||||||||||
Research and development loans (5) (6)
|
2,987
|
597
|
1,195
|
1,195
|
|||||||||||
Operating leases (7)
|
30,434
|
6,192
|
12,330
|
11,912
|
|||||||||||
Inventory purchase commitments (8)
|
30,484
|
30,484
|
—
|
—
|
|||||||||||
Total
|
$
|
459,611
|
$
|
44,455
|
$
|
25,600
|
$
|
369,569
|
(1) | Excludes a liability for uncertain tax positions totaling $6.5 million. This liability has been excluded because the Company cannot currently make a reliable estimate of the period in which the liability will be payable, if ever. |
(2) | Represents the future payments of principal and interest to be made on the Convertible Senior Notes issued in June 2014 and due in 2021. |
(3) | Represents the remaining annual payment of principal and interest to be made on the convertible note payable to Saints Capital. |
(4) | Represents payments for the convertible and non-convertible capital loans. The convertible capital loan and the non-convertible capital loans have a stated maturity of less than one year. However, the repayment of these loans and payment of accrued interest thereon are governed by a restrictive condition, according to which the loan principal must only be repaid if Biotie's consolidated restricted equity is fully covered. Accrued interest must only be paid if Biotie, including its subsidiaries, has sufficient funds for profit distribution as of the most recently ended fiscal year. Interest accrues in the interim. |
(5) | Represents the future principal payments on the R&D loans acquired from Biotie. |
(6) | The amounts do not include interest costs at the loans' applicable interest rates. |
(7) | Represents payments for the operating leases of the Company's Ardsley, NY headquarters, the Company's manufacturing facility in Chelsea, MA, Biotie's headquarters at Turku, Finland, and Biotie's clinical operations in South San Francisco, CA. |
(8) | Represents Ampyra, Zanaflex, and Qutenza inventory commitments. The Ampyra inventory commitment is an estimate as the price paid for Ampyra inventory is based on a percentage of the net product sales during the quarter Alkermes ships inventory to us. Under our supply agreement with Alkermes, we provide Alkermes with monthly written 18-month forecasts, and with annual written five-year forecasts for our supply requirements of Ampyra and two-year forecasts for our supply requirements of Zanaflex Capsules. In each of the five months for Zanaflex and three months for Ampyra following the submission of our written 18-month forecast we are obligated to purchase the quantity specified in the forecast, even if our actual requirements are greater or less. We have agreed to purchase at least 75% of our annual requirements of Ampyra from Alkermes, unless Alkermes is unable or unwilling to meet its requirements, for a percentage of net product sales and the quantity of product shipped by Alkermes to us. |
(9) | Pursuant to the UCB Termination and Transition Agreement, Biotie is required to pay up to $4.3 million (€ 3.9 million) to UCB. The amount that will be paid will be determined based on a percentage of future consideration Biotie will receive from tozadenant. The liability is excluded as the Company cannot currently estimate the period in which the liability will be payable, if ever. |
(In thousands)
|
|||
2016
|
$
|
3,130
|
|
2017
|
6,180
|
||
2018
|
6,337
|
||
2019
|
5,811
|
||
2020
|
5,956
|
||
Later years
|
18,176
|
||
$
|
45,590
|
·
|
The first is U.S. Patent No. 8,007,826, with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Based on the final patent term adjustment calculation of the United States Patent and Trademark Office, or USPTO, this patent will extend into 2027.
|
·
|
The second is U.S. Patent No. 5,540,938, the claims of which relate to methods for treating a neurological disease, such as MS, and cover the use of a sustained release dalfampridine formulation, such as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg for improving walking in people with MS. In April 2013, this patent received a five year patent term extension under the patent restoration provisions of the Hatch-Waxman Act. With a five year patent term extension, this patent will expire in 2018.
We have an exclusive license to this patent from Alkermes (originally with Elan, but transferred to Alkermes as part of its acquisition of Elan's Drug Technologies business).
|
·
|
The third is U.S. Patent No. 8,354,437, which includes claims relating to methods to improve walking, increase walking speed, and treat walking disability in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. This patent is set to expire in 2026.
|
·
|
The fourth is U.S. Patent No. 8,440,703, which includes claims directed to methods of improving lower extremity function and walking and increasing walking speed in patients with MS by administering less than 15 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. This patent is set to expire in 2025.
|
·
|
The fifth is U.S. Patent No. 8,663,685 with claims relating to methods to improve walking in patients with MS by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. Absent patent term adjustment, the patent is set to expire in 2025.
|
·
|
We expect 2016 net revenue from the sale of Ampyra to range from $475 million to $485 million.
|
·
|
Research and development (R&D) expenses in 2016 are expected to range from $195 million to $205 million, excluding share-based compensation charges, a revision from our prior guidance of $165 million to $175 million. The increase in projected research and development expenses in 2016 is primarily driven by the addition of Biotie's tozadenant Phase 3 development program.
|
·
|
Selling, general and administrative (SG&A) expenses in 2016 are expected to range from $195 million to $205 million, excluding share-based compensation charges and transaction expenses related to the Biotie acquisition. This SG&A guidance reflects the addition of the Biotie operations, offset by reductions in current and projected SG&A expenses. We set a high priority on managing selling, general and administrative expenses in 2016.
|
·
|
We expect to be approximately cash flow neutral for the second half of 2016.
|
·
|
Continue progressing our Phase 3 clinical trial of CVT-301 for the treatment of OFF periods in Parkinson's disease. The last patient out of the efficacy trial is expected by the end of 2016 and data is expected by the first quarter of 2017. Our goal is to file a new drug application, or NDA, in the U.S. by the end of the first quarter of 2017 dependent on the timing of the last patient out of the trial.
|
·
|
Proceed with an unblinded analysis of clinical trial data from our Phase 3 clinical trial assessing the use of a twice-daily (BID) formulation of dalfampridine as a treatment for post-stroke walking difficulties (PSWD) after experiencing an ischemic stroke. Data are expected in the fourth quarter of 2016 and will be used to inform the design of planned Phase 3 trials in post-stroke walking difficulties. Data from the Phase 1 multi-dose pharmacokinetic testing for once-daily (QD) dalfampridine are also expected in the fourth quarter of 2016. Subject to positive results from the unblinded trial data and the QD pharmacokinetic results, we are planning to move forward with two concurrent pivotal Phase 3 clinical trials of dalfampridine in PSWD in mid-2017 using a QD formulation.
|
·
|
Based on initial study analyses of a completed Phase 1 safety/tolerability and pharmacokinetic clinical trial of CVT-427, we are planning to advance the development program and are designing protocols for the next studies. We are planning to initiate a special population study to evaluate inhalation in patients with asthma and in smokers in the second half of 2016 and to advance the program into Phase 2 in 2017.
|
·
|
In June 2015 we announced that we had stopped enrollment in our second clinical trial of cimaglermin based on the occurrence of a case of hepatotoxicity (liver injury) (elevated ALT, AST and bilirubin), based on blood test results. We also received a notification of clinical hold from the FDA following submission of this information, and the trial remains subject to the clinical hold. The 22 patients who were dosed in the trial will complete the pre-planned one year of follow up. Outside of the hepatotoxicity case, the safety profile from this trial was consistent with our first Phase 1 trial, but efficacy data was inconclusive which we believe was in part due to the very small number of patients in the trial. We have ongoing analyses and non-clinical studies to further define the nature of the bilirubin signal. We have met with the FDA to present analysis of the data from the cimaglermin studies, as well as data from non-clinical studies, as part of our request that the program be removed from clinical hold.
|
·
|
We are currently enrolling
a Phase 1 trial of rHIgM22 using one of two doses of rHIgM22 or placebo in people with MS who are experiencing an acute relapse. In addition to assessing safety and tolerability during an acute relapse, the study includes exploratory efficacy measures such as a timed walk, magnetization transfer ratio imaging of lesion myelination in the brain and various biomarkers. We expect to complete the trial in the first half of 2017.
|
(In thousands)
|
|
June 30, 2016
|
|
Liability component:
|
|
|
|
Principal
|
|
$
|
345,000
|
Less: debt discount and debt issuance costs, net
|
|
(50,146)
|
|
Net carrying amount
|
|
$
|
294,854
|
Equity component
|
|
$
|
61,195
|
·
|
U.S. accounts receivable, inventory and manufacturing equipment;
|
·
|
Equity interests in the Company's U.S. subsidiaries (other than its U.S. subsidiary of Biotie Therapies Oyj) and up to 65% of the voting equity interests of its directly owned foreign subsidiaries; and
|
·
|
Substantially all other tangible and intangible assets, including equipment, contract rights and intellectual property (other than intellectual property related to Ampyra).
|
Exhibit No
.
|
Description
|
|
10.1
|
Credit Agreement dated June 1, 2016 among the Registrant and certain of its subsidiaries as the Borrowers thereunder and JPMorgan Chase Bank, N.A. as Administrative Agent thereunder.
|
|
10.2*
|
Amended and Restated Addendum #2 to the Supply Agreement dated June 6, 2016 between the Registrant and Biogen Idec International GMBH dated June 30, 2009 as Amended.
|
|
10.3**
|
Employment offer letter dated June 9, 2016, by and between the Registrant and Burkhard Blank, M.D.
|
|
10.4**
|
Acorda Therapeutics, Inc. 2015 Omnibus Incentive Compensation Plan as amended June 8, 2016. Incorporated herein by reference to Appendix A to the Registrant's 2016 Proxy Statement filed as Schedule 14A (File Number 000-50513) on April 29, 2016.
|
|
10.5*
|
Termination and Transition Agreement among Biotie Therapies, Inc. Biotie Therapies AG and UCB Biopharma S.P.R.L., dated August 22, 2014. Incorporated herein by reference to Exhibit 10.12 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
10.6*
|
Amended and Restated License Agreement among Roche Palo Alto LLC, Hoffman-La Roche Inc., F.Hoffman-La Roche Ltd, Synosia Therapeutics, Inc. and Synosia Therapeutics AG, dated December 10, 2008. Incorporated herein by reference to Exhibit 10.13 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
10.7*
|
First Letter Agreement to the Amended and Restated License Agreement among Roche Palo Alto LLC, Hoffman-La Roche Inc., F.Hoffman-La Roche Ltd, Synosia Therapeutics, Inc. and Synosia Therapeutics AG, dated January 14, 2009. Incorporated herein by reference to Exhibit 10.14 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
10.8*
|
Second Letter Agreement to the Amended and Restated License Agreement among Roche Palo Alto LLC, Hoffman-La Roche Inc., F.Hoffman-La Roche Ltd, Synosia Therapeutics, Inc. and Synosia Therapeutics AG, dated October 20, 2009. Incorporated herein by reference to Exhibit 10.15 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
10.9*
|
Third Letter Agreement to the Amended and Restated License Agreement among Roche Palo Alto LLC, Hoffman-La Roche Inc., F.Hoffman-La Roche Ltd, Synosia Therapeutics, Inc. and Synosia Therapeutics AG, dated May 7, 2010. Incorporated herein by reference to Exhibit 10.16 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
10.10*
|
Fourth Letter Agreement to the Amended and Restated License Agreement among Roche Palo Alto LLC, Hoffman-La Roche Inc., F.Hoffman-La Roche Ltd, Synosia Therapeutics, Inc. and Synosia Therapeutics AG, dated September 11, 2012. Incorporated herein by reference to Exhibit 10.17 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
10.11*
|
Letter Exercising the Tier 2 and 3 Field Expansion Option under the Amended and Restated License Agreement among Roche Palo Alto LLC, Hoffman-La Roche Inc., F.Hoffman-La Roche Ltd, Biotie Therapies, Inc. and Biotie Therapies AG, dated February 28, 2013. Incorporated herein by reference to Exhibit 10.18 to Biotie Therapies Corp.'s Registration Statement on Form F-1 (File Number 001-37423) filed on May 14, 2015.
|
|
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
32.1
|
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
Exhibit No
.
|
Description
|
|
32.2
|
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS***
|
XBRL Instance Document.
|
|
101.SCH***
|
XBRL Taxonomy Extension Schema Document.
|
|
101.CAL***
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
101.DEF***
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
101.LAB***
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
101.PRE***
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
* | Portions of this exhibit were redacted pursuant to a confidential treatment request filed with the Secretary of the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. |
** | Indicates management contract or compensatory plan or arrangement. |
*** | In accordance with Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall be deemed to be "furnished" and not "filed." |
Acorda Therapeutics, Inc.
|
||
By:
|
/s/
Ron Cohen
|
|
Date: August 4, 2016
|
Ron Cohen, M.D.
President, Chief Executive Officer and Director
(Principal Executive Officer)
|
By:
|
/s/
Michael Rogers
|
|
Date: August 4, 2016
|
Michael Rogers
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
Exhibit No.
|
Description
|
|
10.1
|
Credit Agreement dated June 1, 2016 among the Registrant and certain of its subsidiaries as the Borrowers thereunder and JPMorgan Chase Bank, N.A. as Administrative Agent thereunder.
|
|
10.2*
|
Amended and Restated Addendum #2 to the Supply Agreement dated June 6, 2016 between the Registrant and Biogen Idec International GMBH dated June 30, 2009 as Amended
.
|
|
10.3**
|
Employment offer letter dated June 9, 2016, by and between the Registrant and Burkhard Blank, M.D.
|
|
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
|
32.1
|
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2
|
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS***
|
XBRL Instance Document.
|
|
101.SCH***
|
XBRL Taxonomy Extension Schema Document.
|
|
101.CAL***
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
101.DEF***
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
101.LAB***
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
101.PRE***
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
* | Portions of this exhibit were redacted pursuant to a confidential treatment request filed with the Secretary of the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. |
** | Indicates management contract or compensatory plan or arrangement. |
*** | In accordance with Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall be deemed to be "furnished" and not "filed." |
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1 Month Acorda Therapeutics Chart |
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