Spinal Cord Injury
S p a s t i c i t y
M u l t i p l e S c l e r o s i s
Stroke
Parkinson’s Disease
Ep ilepsy
Heart Failure
Migraine
2014 ANNUAL REPORT
Acorda’s mission is to develop
therapies that restore function
and improve the lives of people
with neurological disorders.
Rick
DIAGNOSED WITH MS IN 1994
Dear Members of the Acorda Community:
In 2014, we made significant strides in our mission to develop therapies that restore function and
improve the lives of people with neurological disorders. Our progress was enabled by our grounding
in scientific, medical and business excellence, and our focus on three core value drivers: AMPYRA®
commercial performance; clinical pipeline; and business development.
We responded effectively to these challenges, initiating our Phase
3 post-stroke study with our existing twice-daily formulation of
dalfampridine and also launching work on a new QD formulation
with several independent collaborators. We have also engaged with
FDA regarding PLUMIAZ and expect to provide a detailed update
in the second quarter of 2015.
As anticipated, a number of parties have filed challenges to our
AMPYRA patents. Our legal team is prepared for these challenges.
We have five Orange Book listed patents on AMPYRA that extend
through 2027, and will vigorously defend our intellectual property.
Looking ahead, we are focused on execution in the areas that are
critical to growing our business in the coming years:
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Continue to build value in the AMPYRA brand in MS.
Execute successfully on our high-value pipeline programs.
Identify additional business development opportunities
that will build on Acorda’s leading capabilities in neurology
development and specialty pharmaceutical commercialization.
I want to take this opportunity to recognize Acorda’s associates for
their dedication and the urgency they bring to developing cutting
edge therapies. I’m especially pleased that our newest colleagues
from Civitas share this commitment; the integration of our two
companies has resulted in a stronger Acorda with a substantially
enhanced product pipeline and capabilities.
On behalf of our management team and Board of Directors, thank
you to our shareholders for your continued support. We are excited
about our opportunities to build value in 2015 and beyond, and I
look forward to updating you on our progress.
Ron Cohen
President and CEO
Highlights in 2014 included:
AMPYRA net revenue increased 21% in 2014 to $366 million.
Due to the efforts and expertise of our commercial and
medical education teams, AMPYRA is increasingly considered
a standard of care among neurologists and the multiple
sclerosis (MS) community for improving walking in MS. More
than 100,000 people with MS in the U.S. have tried this
important therapy since its launch in 2010, and we have been
gratified to hear frequently from people who have benefited
from AMPYRA about how much this has meant to them and
their families. We are projecting continued growth of AMPYRA
in 2015, with anticipated net sales between $405-$420 million.
We acquired Civitas Therapeutics, adding global rights for two
promising compounds to our pipeline, as well as the ARCUS
technology platform, which has potential applications in
multiple disease states. We also acquired a commercial-scale
manufacturing facility for ARCUS-based products.
We advanced two therapies into Phase 3 clinical trials:
dalfampridine for chronic post-stroke walking deficits (PSWD)
and CVT-301 for OFF episodes in Parkinson’s disease. Both
of these compounds would address large patient populations
with significant unmet medical needs.
We completed our first Phase 1 study of rHIgM22 for
remyelination in MS. The safety and tolerability findings support
continued development of this therapy, which has a novel
mechanism. We expect to initiate a second Phase 1 trial in the
second quarter of 2015. Remyelination is widely considered
to be one of the next frontiers in the treatment of MS. We are
excited to be advancing this therapy in clinical trials.
We continued to enroll the second Phase 1 study of
cimaglermin alfa (also known as GGF2) in heart failure,
and expect it to be completed in the second half of 2015.
Cimaglermin represents a novel approach to improving heart
function; our first Phase 1 trial showed additive improvements
in cardiac ejection fraction over optimized therapy in people
with Class 2 and 3 heart failure.
We ended 2014 in a strong financial position, with over $300
million in cash and projecting a cash flow positive year in 2015.
We also experienced two disappointments in 2014: a proposed
once-daily (QD) formulation of dalfampridine proved inadequate
for inclusion in our post-stroke Phase 3 program, and we received
a Complete Response Letter (CRL) from the U.S. Food and Drug
Administration (FDA) regarding our New Drug Application (NDA) for
approval of PLUMIAZ to treat seizure clusters. However, the mark
of success is not the absence of disappointments, but in how one
responds to them.
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ADVANCED
PIPELINE
AMPYRA® (DALFAMPRIDINE)
$366.2 million in 2014 net sales, a 21% increase over 2013
More than 100,000 people with MS have tried AMPYRA
since launch
ZANAFLEX® (TIZANIDINE HCI)
QUTENZA® (CAPSAICIN)
DALFAMPRIDINE
Initiated Phase 3 clinical trial for chronic post-stroke
walking deficits (PSWD) in December 2014
CVT-301
Initiated Phase 3 clinical trial for OFF episodes in
Parkinson’s disease in December 2014
PLUMIAZ™
CIMAGLERMIN ALFA
Initiated second Phase 1 heart failure clinical trial in
November 2013; results expected in 2015
rHlgM22
Completed first Phase 1 MS clinical trial in 2014
Expect to initiate second Phase 1 study in 2Q 2015
CVT-427
Preparing for first Phase 1 clinical trial
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We hav e a de e p u nde r s tandi ng
o f and e xp e rie nc e i n ne rv o u s
s ys t e m re s earch ,
pro d u ct de v e l o p me nt
and c o mme rcializatio n.
CIVITAS THERAPEUTICS
ACQUISITION
In October 2014, we completed the acquisition of Civitas Therapeutics, a privately-held biotechnology
company with two novel neurology products in development. There are three aspects that made this
transaction very attractive to us, and that have the potential to deliver substantial value over time:
PRODUCTS:
We obtained global rights to CVT-301 and CVT-427,
ARCUS® TECHNOLOGY:
ARCUS is a proprietary dry-powder pulmonary delivery
in development for Parkinson’s disease and migraine,
system that has potential applications in multiple disease
respectively. CVT-301 offers a late-stage opportunity that
areas. This platform is being studied to allow consistent
addresses a clear unmet need for people with Parkinson’s
and precise delivery of significantly larger doses of
disease—treating OFF episodes, which become more
medication than are possible with conventional pulmonary
frequent as the disease progresses. OFF episodes
delivery systems. The ARCUS inhaler is a passive, breath-
are defined by periods of time when background
actuated, reusable device operated by the user breathing in
levodopa (L-dopa) therapy does not adequately control
on the mouthpiece. The ARCUS technology has been used
Parkinson’s symptoms, leading to reduced ability to
to deliver more than one million doses to patients in clinical
move, muscle stiffness and tremor. These episodes can
trials of various compounds.
be very disruptive to the lives of people with Parkinson’s
disease, their families and caregivers. CVT-301 utilizes
the ARCUS® technology and is being studied to provide
Our acquisition of Civitas included a commercial-scale
manufacturing facility for ARCUS-based products, located
rapid, reliable delivery of a precise dose of L-dopa
in Chelsea, MA.
through the lungs to return people with Parkinson’s to an
ON state; L-dopa is viewed as the gold standard in the
treatment of Parkinson’s disease. We initiated a Phase 3
TEAM:
Just as important as the products and technology, the Civitas
clinical trial of CVT-301 in December 2014.
team joining Acorda has strengthened our organization. In
CVT-427 is a triptan-based migraine therapy; we are
experience with the development programs for CVT-301 and
preparing to initiate the first Phase 1 clinical trial of
CVT-427, our organizations were very closely aligned in terms
this compound. CVT-427 also utilizes the ARCUS
of culture, values and commitment to the patients we serve.
addition to their expertise in the ARCUS technology and
technology platform.
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2015 GUIDANCE
Our guidance range reflects
We’re investing in late-stage trials
We place a high priority on
continued confidence in the growth
for CVT-301, dalfampridine in
managing SG&A; our guidance
of AMPYRA, increasing from $366.2
chronic post-stroke walking deficits
represents a minimal increase over
million in net sales from 2014.
(PSWD) and PLUMIAZ.
Acorda has 5 clinical-stage
programs that have potential to
improve the lives of millions of
patients and drive shareholder value.
2014 despite added infrastructure
related to the Civitas acquisition.
2014 HIGHLIGHTS
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MANAGEMENT
TEAM
Ron Cohen, M.D.
David Lawrence, M.B.A.
President & Chief Executive Officer
Chief of Business Operations
Richard P. Batycky, Ph.D.
Michael Rogers
Chief Technology Officer
Chief Financial Officer
and Site Head
Andrew R. Blight, Ph.D.
Chief Scientific Officer
Lauren Sabella
Chief Commercial Officer
Tierney Saccavino
Enrique J. Carrazana, M.D.
Executive Vice President,
Chief Medical Officer
Corporate Communications
Denise Duca, Ed. M.
Executive Vice President,
Human Resources
Jane Wasman, J.D.
President, International &
General Counsel
Andrew A. Hindman
Chief Business Development Officer
BOARD OF
DIRECTORS
Ron Cohen, M.D.
Founder
Barry Greene
Board Member since 2007
Peder K. Jensen, M.D.
Board Member since 2011
John P. Kelley
Board Member since 2008
Sandra Panem, Ph.D.
Lorin J. Randall
Board Member since 1998
Board Member since 2006
Steven M. Rauscher
Ian F. Smith
Board Member since 2005
Board Member since 2007
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Kristie
DIAGNOSED WITH MS IN 1999
CONTACT:
Jeff Macdonald
Senior Director, Corporate Communications
jmacdonald@acorda.com
914-326-5232