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Acorda Therapeutics

acor · NASDAQ Healthcare
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Industry Drug Manufacturers - Specialty & Generic
Employees 201-500
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FY2018 Annual Report · Acorda Therapeutics
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2018 ANNUAL REPORT

NOW AVAILABLE

LETTER  
FROM  
THE CEO

DEAR SHAREHOLDER:

2018 closed with a major milestone for Acorda – on 
December 21, the U.S. Food and Drug Administration 
(FDA) approved INBRIJA™ (levodopa inhalation powder) 
for the intermittent treatment of OFF episodes  
(also known as OFF periods) in adults with Parkinson’s 
disease treated with carbidopa/levodopa. 

INBRIJA – ADDRESSING AN IMPORTANT UNMET 
MEDICAL NEED IN THE PARKINSON’S COMMUNITY 
Levodopa, INBRIJA’s active ingredient, in combination with 
carbidopa, is widely considered the gold standard treatment 
for Parkinson’s disease. OFF periods are the re-emergence 
of Parkinson’s symptoms; variable absorption of levodopa 
in the gut, as well as the drug’s short half-life, contribute to 
the development of OFF periods. OFF periods are considered 
among the most troubling unmet medical needs in 
Parkinson’s, by both people with Parkinson’s (PwPs) and  
their healthcare professionals. INBRIJA is the first and 
only inhaled levodopa for on-demand treatment of OFF 
periods, providing a significant new treatment option for the 
Parkinson’s community.

At the end of February 2019, we announced the commercial 
availability of INBRIJA. Our sales force is now calling on 
movement disorder specialists, and our market access 
and medical teams are meeting with managed care and 
payor groups to educate them about INBRIJA’s clinical 
profile. The feedback from healthcare professionals, patient 
advocacy organizations and the patient community has been 
enthusiastic. As is typical in a launch year, we do not intend 
to provide revenue guidance for INBRIJA in 2019, but plan 
to provide our shareholders with other metrics to aid in 
evaluating the progress of the launch.

We estimate that approximately 350,000 PwPs in the U.S. 
currently experience OFF periods while on a carbidopa/
levodopa regimen. We believe that peak sales of INBRIJA  
in the U.S. will exceed $800 million.

We submitted a Marketing Authorization Application (MAA) 
for INBRIJA to the European Medicines Agency (EMA) in 
March 2018 and expect a final decision from the European 
Commission before the end of 2019. We plan to seek a 
partner for the commercialization of INBRIJA in Europe  
and Japan. 

In September 2018, by a 2-1 vote, the United States Court 
of Appeals for the Federal Circuit upheld the District Court’s 
decision to invalidate our patents for AMPYRA®, allowing 
generic manufacturers to enter the market. We disagree 
with the ruling, which we believe also has broad negative 
implications for biopharmaceutical innovation, and we 
have filed an appeal with the Supreme Court. We continue 
to market branded AMPYRA so that it remains available 
to the patients who rely on it. In 2018, AMPYRA reported 
net revenue of $455 million. However, revenues have 
declined significantly since September 2018, and we expect 
continued declines as additional generics enter the market. 
Therefore, we are not providing AMPYRA revenue guidance 
for 2019.

We ended the year with approximately $445 million on 
our balance sheet. This was a result of executing on our 
detailed contingency plans: monetizing non-strategic 
assets, maximizing AMPYRA revenue and remaining fiscally 
disciplined. We believe this cash is adequate for the  
Company to become cash flow positive, based on our  
long-range projections.

LEVERAGING OUR LEADING SPECIALTY SALES  
AND MARKETING ORGANIZATION
Acorda has developed one of the most effective and 
experienced specialty sales teams in the U.S., with an 
average of 18 years in the pharmaceutical industry. 
We believe that our successful neurology commercial 
experience and infrastructure position us well for a 
successful launch of INBRIJA. Our field sales and medical 
teams are trained and we have launched a full suite of  
in-office and digital educational materials, enabling a variety 
of opportunities for healthcare professionals and PwPs to 
learn about INBRIJA. 

We are distributing INBRIJA via a closed network of specialty 
pharmacies. All prescriptions are triaged by our Prescription 
Support Services center. A customer service representative 
connects with each patient, performs an individualized 
benefits investigation, and speaks directly to the patient 
regarding the cost of their prescription and the support that 
we are providing them.

LEADERSHIP IN THE PARKINSON’S COMMUNITY
A significant feature of Acorda’s “brand” is the personal 
attention and support we provide to the patient communities 
affected by our products. As we did previously with the 
MS community, we have established close partnerships 

with Parkinson’s patient advocacy organizations and 
with individual PwPs and their families. Our disease 
state Facebook page, The Many Faces of OFF ®, has over 
106,000 followers, making it the largest industry-sponsored 
Facebook site for Parkinson’s. We have also seen a 
progressive increase in engagement on this site among the 
Parkinson’s community, where it has become a source of 
peer-to-peer encouragement and support.

Our consumer education program, “Live Well. Do Tell.®” 
provides wellness programming for the Parkinson’s 
community. We periodically convene an advisory board 
comprising all four “pillars” of the community: healthcare 
professionals, patient advocacy organizations, PwPs and 
care partners. In 2018, based on the advisory board’s 
recommendation, we launched Framing OFF Through Art SM, 
which uses custom works of art to share a PwP’s experience 
of living with OFF periods.

ARCUS 
Our proprietary ARCUS® drug delivery technology began in 
the laboratory of Dr. Robert S. Langer of the Massachusetts 
Institute of Technology. ARCUS transforms medicines into 
light, dry powders and allows higher doses of medication 
to be delivered via inhalation, versus traditional dry powder 
inhalers. This technology has the potential to deliver inhaled 
medicines for a variety of both systemic and pulmonary 
conditions. 

We believe ARCUS will be an important platform for our 
future growth and we are working to identify a target in 
migraine appropriate for development for inhalation. We are 
also working with the Bill & Melinda Gates Foundation to 
develop a dry powder version of lung surfactant, a treatment 
for neonatal respiratory distress syndrome. While this 
program is aimed primarily at developing a product for use 
in developing countries, we believe it also will help us to 
adapt ARCUS for commercial pediatric uses.

2019 PRIORITIES
•  Successful U.S. launch and commercialization of INBRIJA

•  Identify and advance a pipeline candidate for the use  

of ARCUS in migraine

•  Maintain a strong balance sheet

On behalf of our Leadership Team, Board of Directors 
and our associates, thank you, our shareholders, for your 
continued support. We look forward to building on the 
successes of 2018 to deliver substantial shareholder value 
in 2019.

RON COHEN, M.D.  
PRESIDENT AND CEO

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NOW AVAILABLE

On December 21, 2018, the FDA approved INBRIJA for 
the intermittent treatment of OFF episodes, also known 
as OFF periods, in adults with Parkinson’s disease 
taking carbidopa/levodopa.

On February 28, 2019, Acorda announced its commercial launch. INBRIJA is an  
inhaled form of levodopa, the gold standard for the treatment of Parkinson’s,  
based on the innovative ARCUS® technology.

Despite being on treatment, patients may experience OFF periods as their Parkinson’s 
progresses, which can be disruptive. Acorda estimates that 350,000 people in the  
U.S. are currently on a carbidopa/levodopa regimen and experience OFF periods  
and believes that peak sales of INBRIJA in the U.S. will exceed $800 million.

Information about INBRIJA can be found at www.inbrija.com

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ARCUS ®

The ARCUS technology transforms medicines into light, dry powders that can be 
inhaled deep into the lungs. Historically, inhaled dry powder medications have 
allowed relatively low doses of a medication to be delivered; ARCUS is designed to 
allow the delivery of significantly larger doses, through an inhalation device that is 
activated by the patient’s own breath. 

ARCUS changes the size and shape of the particles – think of a dandelion “puff ball” 
 – making them far more aerodynamically efficient and allowing them to be inhaled 
deeply into the lungs.

The core ARCUS technology emerged from the lab of Dr. Robert S. Langer at MIT.

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PARKINSON’S 
COMMUNITY

FRAMING OFF THROUGH ART SM 

Framing OFF Through Art uses the power of art to illustrate how OFF periods impact 
those living with Parkinson’s, and to encourage people with Parkinson’s to recognize 
their OFF symptoms and communicate them to their care partner and healthcare 
professionals. This initiative builds on Acorda’s “Live Well. Do Tell.®” program, which we 
launched in March 2018. Each work of art is inspired by the personal story of a person 
with Parkinson’s and their care partner, and in collaboration with an artist who has their 
own connection to Parkinson’s.

The art created for Framing OFF Through Art 
can be found at

www.livewelldotell.org

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2018 HIGHLIGHTS

INBRIJA  
FDA APPROVED
DECEMBER 21, 2018

OUR MISSION IS TO DEVELOP THERAPIES THAT 
RESTORE FUNCTION AND IMPROVE THE LIVES  
OF PEOPLE WITH NEUROLOGICAL DISORDERS.

The workplace environment created by our associates 
has received national and local recognition.  Our culture of 
integrity, collaboration, and open communication is critical 
to advancing our mission to develop therapies that improve 
the lives of people with neurological disorders.

AMPYRA NET SALES

$455.1M

$

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2018 YEAR END CASH BALANCE *

$445M

*Cash, cash equivalents and investments

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MANAGEMENT

LEADERSHIP TEAM

Ron Cohen, M.D.
President and Chief  
Executive Officer

Burkhard Blank, M.D.
Chief Medical Officer  
and Head of R&D

David Lawrence, M.B.A.
Chief, Business Operations 
and Principal Accounting 
Officer

Lauren Sabella
Chief Commercial Officer

Peter S. Carbone
Senior Vice President,  
Quality

Tierney Saccavino
Executive Vice President, 
Corporate Communications

Denise Duca, Ed.M.
Executive Vice President, 
 Human Resources

Jane Wasman, J.D.
President, International 
 and General Counsel

Andrew A. Hindman
Chief Business Officer

BOARD OF DIRECTORS

Ron Cohen, M.D.
Founder

Steven M. Rauscher 
Board Member since 2005

Barry Greene 
Board Member since 2007

Catherine D. Strader, Ph.D.
Board Member since 2017

Peder K. Jensen, M.D. 
Board Member since 2011

John P. Kelley
Board Member since 2008

Sandra Panem, Ph.D.
Board Member since 1998

Lorin J. Randall 
Board Member since 2006

ACORDA, ACORDA THERAPEUTICS, the stylized ACORDA THERAPEUTICS LIFE. SCIENCE. mark, AMPYRA, 
INBRIJA, the INBRIJA logo, ARCUS, THE MANY FACES OF OFF, Live Well. Do Tell., the Live Well. Do Tell. 
logo, and Framing OFF Through Art are all trademarks of Acorda Therapeutics, Inc.  
©2019 Acorda Therapeutics, Inc. All rights reserved. 

CONTACT
Felicia Vonella 
Vice President,  
Investor Relations 
fvonella@acorda.com 
914-326-5146