Delaware
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000-50513
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13-3831168
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(State or other jurisdiction
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(Commission
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(I.R.S. Employer
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of incorporation)
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File Number)
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Identification No.)
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15 Skyline Drive, Hawthorne, NY | 10532 | |||
(Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (914) 347-4300
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Acorda Therapeutics, Inc.
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November 1, 2010
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By:
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/s/ David Lawrence
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Name: David Lawrence
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Title: Chief Financial Officer
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AMPYRA® (dalfampridine) Gross Sales of $52.6 million
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Approximately 31,000 People with MS have Filled an AMPYRA Prescription as of September 30, 2010
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Approximately 6,300 Physicians have Written at Least One Prescription for AMPYRA as of September 30, 2010
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Company Reports $12.4 Million Net Income
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From March through September 2010, approximate total prescriptions (TRx) filled for AMPYRA were: 870 (March), 4,880 (April), 8,110 (May), 17,400 (June), 17,310 (July), 18,140 (August) and 18,350 (September). These totals include prescriptions for free drug filled through the AMPYRA patient assistance program.
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From March through September 2010, new patients receiving AMPYRA were approximately: 570 (March), 3,120 (April), 4,250 (May), 6,460 (June), 6,720 (July), 6,230 (August) and 3,970 (September). These totals include prescriptions for free drug filled through the AMPYRA patient assistance program.
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As of September 30, 2010, approximately 31,000 people with MS have filled a prescription for AMPYRA, representing almost 8% of all MS patients in the United States
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The rate of first refill as of September 30, 2010 was 67%, based on a weighted average from a cohort of approximately 17,500 patients who received an initial one-month prescription in March-August.
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Approximately 6,300 healthcare professionals have written at least one prescription for AMPYRA as of September 30, 2010.
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The Company’s original target call list included 5,500 physicians, who were selected based on immunomodulator prescribing data. Among those physicians who are in the top five prescribing deciles (the group that writes 50% of prescriptions), approximately 87% have written at least one AMPYRA prescription. Based on analysis of actual AMPYRA prescribers, the Company has expanded its target list to approximately 10,000 physicians.
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Consistent with the product label, AMPYRA is being used both with and without immunomodulators. In a sample of approximately 10,000 AMPYRA patients from two of the largest specialty pharmacy providers (SPPs), approximately 40% were not on immunomodulator therapy.
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Also consistent with the product label, AMPYRA is being prescribed to patients with all types of MS. The patient’s type of MS has been specified on approximately 67% of AMPYRA prescription request forms received to date. Of these patients, 66% have been diagnosed with relapsing remitting MS, and 34% have been diagnosed with one of the three progressive forms of MS.
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Inventory on hand at the 12 SPPs that distribute AMPYRA (does not include Kaiser) was approximately two weeks as of September 30, 2010. These SPPs are contractually obligated to hold no more than 30 days of inventory.
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As of September 30, 2010, approximately 75% of commercially-insured individuals have no or limited prior authorizations (PAs) for AMPYRA. Limited PAs are defined as those that require only an MS diagnosis, documentation of no contraindications, and/or simple documentation that the patient has walking impairment; such documentation may include a Timed 25-Foot Walk (T25W) test. Approximately 20% of commercially-insured individuals are subject to more restrictive PAs, which may include requirements for multiple timed walk tests and/or EDSS score requirements to initiate therapy, and/or objective measures of ambulation improvement to reauthorize AMPYRA therapy. Acorda estimates approximately 5% of commercially-insured individuals are currently blocked from receiving reimbursement for AMPYRA. Access figures have been calculated based on the number of pharmacy lives reported by commercial healthcare plans. Managed care plans continue to evaluate AMPYRA, and may change requirements over time. In addition, some plans have not yet formally reviewed AMPYRA.
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Pent up demand early in the launch of AMPYRA created a backlog of prescriptions that continued to be filled during the third quarter. This backlog was eliminated by the end of the third quarter.
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Currently, approximately 10% of shipped product is free to patients enrolled in the AMPYRA patient assistance program.
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In October 2010, the European Patent Office posted a “Communication of Intent to Grant a Patent” for a patent submitted by the Company with “composition for use” and other use claims directed to sustained release aminopyridine compositions for, among other things, increased walking speed, improving lower extremity muscle strength, or improving lower extremity muscle tone, in patients with MS. A corresponding patent is currently under review by the U.S. Patent and Trademark Office.
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Data on AMPYRA was presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in October 2010.
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Preclinical stroke data on Glial Growth Factor 2 (GGF2) was published in Neuropharmacology. Data from two studies showed GGF2 promoted functional recovery from stroke with treatment initiated up to seven days after the event.
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The Company has resolved the vial filling issues associated with GGF2 production and is now completing preparations for its Phase 1 clinical trial in patients with heart failure.
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Acorda Therapeutics, Inc.
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Condensed Consolidated Balance Sheet Data
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(in thousands)
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|||
(Unaudited)
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September 30,
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December 31,
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2010
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2009
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Assets
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Cash, cash equivalents and short-term investments
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$ 245,817
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$ 272,092
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Trade receivable, net
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18,369
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5,879
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Other current assets
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9,145
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8,417
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Finished goods inventory
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26,182
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6,893
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Property and equipment, net
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3,321
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1,891
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Intangible assets, net
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22,013
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17,149
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Other assets
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6,574
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7,150
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Total assets
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$ 331,421
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$ 319,471
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Liabilities and stockholders' equity
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Accounts payable, accrued expenses and other liabilities
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$ 43,167
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$ 26,589
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Deferred product revenue
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29,327
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30,704
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Current portion of deferred license revenue
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9,429
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9,429
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Current portion of notes payable
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1,144
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-
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Current portion of revenue interest liability
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6,381
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6,179
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Long term notes payable
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6,132
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7,112
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Non-current portion of revenue interest liability
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4,693
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6,268
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Non-current portion of deferred license revenue
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88,786
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95,857
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Stockholders' equity
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142,362
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137,333
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Total liabilities and stockholders' equity
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$ 331,421
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$ 319,471
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Acorda Therapeutics, Inc.
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|||||||||
Consolidated Statements of Operations
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(in thousands, except per share amounts)
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|||||||||
(Unaudited) | |||||||||
Three Months Ended | Nine Months Ended | ||||||||
September 30, | September 30, | ||||||||
2010
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2009
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2010
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2009
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Revenues:
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Gross product sales
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$ 66,188
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$ 14,463
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$126,885
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$ 43,835
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Less: discounts and allowances
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(4,923)
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(1,606)
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(9,751)
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(5,959)
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Net sales
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61,265
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12,857
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117,134
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37,876
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License revenue
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2,357
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2,357
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7,071
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2,357
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Total revenues
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63,622
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15,214
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124,205
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40,233
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Costs and expenses:
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Cost of sales
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11,666
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2,602
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22,574
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8,112
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Research and development
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7,970
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8,198
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22,628
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23,982
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Selling, general and administrative
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30,723
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23,415
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91,549
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67,363
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Total operating expenses
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50,359
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34,215
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136,751
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99,457
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Operating income (loss)
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$ 13,263
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$ (19,001)
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$ (12,546)
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$ (59,224)
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Other expense, net
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(825)
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(429)
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(2,894)
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(2,243)
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Net income (loss)
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$ 12,438
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$ (19,430)
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$ (15,440)
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$ (61,467)
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Net income (loss) per common share - basic
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$ 0.32
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$ (0.51)
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$ (0.40)
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$ (1.63)
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Net income (loss) per common share - diluted
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$ 0.31
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$ (0.51)
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$ (0.40)
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$ (1.63)
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Weighted average per common share - basic
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38,450
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37,750
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38,261
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37,701
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Weighted average per common share - diluted
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39,988
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37,750
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38,261
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37,701
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