Acorda Therapeutics, Inc. (NASDAQ:ACOR) Files An 8-K Costs Associated with Exit or Disposal Activities
Item 2.05Costs Associated with Exit or Disposal Activities
On April 5, 2017, Acorda Therapeutics, Inc. (the Company) issued
a press release announcing a corporate restructuring to reduce
its cost structure and focus its resources on its two late-stage
programs, CVT-301 and tozadenant, as well as on maximizing
patient access to AMPYRA (dalfampridine) Extended Release
Tablets, 10 mg at least through July 2018.
The adoption of this restructuring plan follows the
previously-announced decision by the United States District Court
for the District of Delaware invalidating certain patents
pertaining to AMPYRA. Under this ruling, Acorda expects to
maintain exclusivity to AMPYRA through July 2018. The Company
will appeal the decision.
As part of this restructuring, the Company is reducing headcount
by approximately 20%. The majority of the reduction in personnel
is expected to be completed in April 2017. As a result, the
Company expects to realize estimated annualized cost savings from
the reduction in personnel of approximately $21.0 million
beginning in the second quarter of 2017. Acorda estimates that
during 2017 it will incur approximately $8.0 million of pre-tax
charges for severance and employee separation related costs
related to the restructuring, primarily during the second
quarter. The pre-tax charges include a cash component of
approximately $7.5 million representing non-recurring employee
charges for severance payments and benefits and a non-cash
component of approximately $0.5 million representing stock
compensation charges. The Company expects that there will be
additional non-severance related costs associated with the
restructuring and is currently performing an internal review to
determine the effect of the restructuring on the non-severance
related costs. The Company is unable to provide an estimate of
the non-severance related costs until the internal review is
completed.
As of December 31, 2016, the Company had cash and cash
equivalents of approximately $159 million and expects to be cash
flow positive for 2017. The Company has $345 million of
convertible senior notes due in 2021 with a conversion price of
$42.56. Acorda believes that the cost savings from the
restructuring and subsequent operating expense reductions will
enable it to fund operations through the key milestones for its
late-stage development programs, including the commercial launch
of CVT-301, pending approval from the U.S. Food and Drug
Administration (FDA), and Phase 3 data for tozadenant. The
Company plans to file a New Drug Application (NDA) for CVT-301
with the FDA in the second quarter of 2017.
A copy of the press release is attached as Exhibit 99.1 to this
Current Report on Form 8-K and is incorporated by reference into
this Item.
The statements in this report are subject to risks and
uncertainties that could cause actual results to differ
materially, including: the ability to realize the benefits
anticipated from the Biotie and Civitas transactions, among other
reasons because acquired development programs are generally
subject to all the risks inherent in the drug development process
and our knowledge of the risks specifically relevant to acquired
programs generally improves over time; the ability to
successfully integrate Bioties operations and Civitas operations,
respectively, into our operations; we may need to raise
additional funds to finance our expanded operations and may not
be able to do so on acceptable terms; our ability to successfully
market and sell Ampyra (dalfampridine) Extended Release Tablets,
10 mg in the U.S., which will likely be materially adversely
affected by the recently announced court decision in our
litigation against filers of Abbreviated New Drug Applications
(each, an ANDA) to market generic versions of Ampyra in the U.S.;
third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at
acceptable rates or at all and may impose restrictive prior
authorization requirements that limit or block prescriptions; the
risk of unfavorable results from future studies of Ampyra or from
our other research and development programs, including CVT-301 or
any other acquired or in-licensed programs; we may not be able to
complete development of, obtain regulatory approval for, or
successfully market CVT-301, any other products under
development, or the products that we will acquire when we
complete the Biotie transaction; the occurrence of adverse safety
events with our products; delays in
obtaining or failure to obtain and maintain regulatory approval
of or to successfully market Fampyra outside of the U.S. and our
dependence on our collaborator Biogen in connection therewith;
competition; failure to protect our intellectual property, to
defend against the intellectual property claims of others or to
obtain third party intellectual property licenses needed for the
commercialization of our products; and failure to comply with
regulatory requirements could result in adverse action by
regulatory agencies.
Item 8.01Other Events
The information reported in Item 2.05 is incorporated into this
Item by reference.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
Exhibit No. |
Description |
99.1 |
Press Release dated April 5, 2017 |
About Acorda Therapeutics, Inc. (NASDAQ:ACOR)
Acorda Therapeutics, Inc. is a biopharmaceutical company. The Company is engaged in the identification, development and commercialization of therapies that restore function and recovers the lives of people with neurological disorders. Its commercial products include Ampyra, Fampyra, Zanaflex Capsules and a generic version of the capsules, Zanaflex tablets and Qutenza. Its research and development programs include CVT-301, Dalfampridine, Plumiaz, Neuregulin Program, Remyelinating Antibodies Program, CVT-427 and Chondroitinase Program. Its Ampyra is an oral drug for the treatment to improve walking in patients with multiple sclerosis. Zanaflex Capsules and tablets are used as short-acting drugs for the management of spasticity. Qutenza is a dermal patch for the management of neuropathic pain associated with post-herpetic neuralgia. Its pipeline of neurological therapies addresses a range of disorders, including Parkinson’s disease, chronic post-stroke walking deficits and migraine. Acorda Therapeutics, Inc. (NASDAQ:ACOR) Recent Trading Information
Acorda Therapeutics, Inc. (NASDAQ:ACOR) closed its last trading session 00.00 at 17.05 with 1,824,618 shares trading hands.