Acorda Therapeutics has popped the champaign, celebrating the decision by the U.S. Food & Drug Administration (FDA) to approve the marketing of Ampyra (dalfampridine), the first (and only) oral treatment indicated to improve walking in patients with multiple sclerosis (MS). Even before the company launches the drug in March, rumors are rampant that deeper-pocketed pharma companies looking to broaden the breadth of their own MS drug portfolios, such as Biogen Idec or Teva Pharmaceuticals, could move quickly to tender an all cash offer.
As framed by my collegue Trista Morrison in her column yesterday: Will the approval for Ampyra-which takes significant risks off the table-pave the way for a third-party buyout?
To the contrary, an analysis of recent regulatory filings with the SEC suggests Acorda Therapeutics (NASDQ:ACOR), has the liquidity, capital, and existing infrastructure available to launch Ampyra on its own:
- Commenting on third-quarter results back in October, chief executive Ron Cohen said he expected to enter 2010 with cash on hand of about $250 million. This amount does not include milestone payments due from Biogen Idec, which purchased exclusive rights to market Ampyra in ex-stateside markets, such as Europe.
- Contractual obligations coming due in one to three years, such as inventory purchase commitments and royalty fees (excluding Elan), total a manageable $17.4 million.
- Available net-operating loss carry-forwards of approximately $216.5 million and R&R tax credit carryforwards of about $1.6 million (as of September 30), which are available to offset future taxable incomes -- in of themself -- are immaterial for deeper-pocketed companies earning billions in revenues.
Additionally, Ampyra has been designated an orphan drug by the FDA, allowing for seven years of market exclusivity in the U.S. The EMEA also designated Fampridine-SR as a New Active Substance, entitling the drug to 10 years of market exclusivity in Europe.
The company is positioned to jump out of the gate come March. At September 30, the company already had a specialty sales force of 73 sales professionals in place, salivating to call on high-volume (RX) prescribers and other influential neurologists who specialize in treating patients with neuromuscular disorders. Management has said it expects to have a sales force of approximately 100 reps trained and in place for an anticipated March launch.
Perhaps the primary reason why an acquisition -- unless hostile -- of Acorda would be unlikely: CEO Cohen and CFO David Lawrence would receive severance compensation packages valued at only $2.5 million and $1.3 million, respectively. With more than 400,000 MS sufferers in this country, of which up to 275,000 are estimated to be likely candidates for Ampyra treatment, the status quo looks more like a certainty for all vested insiders.