Acorda 2013 Fourth Quarter/ Full Year...
Transcript of Acorda 2013 Fourth Quarter/ Full Year...
![Page 1: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/1.jpg)
Acorda 2013 Fourth Quarter/Full Year EarningsFebruary 13, 2014
![Page 2: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/2.jpg)
Forward Looking Statements
This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including our ability to successfully market and sell 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 Diazepam Nasal Spray or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market Diazepam Nasal Spray or other products under development; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaboration partner Biogen Idec in connection therewith; competition, including the impact of generic competition on Zanaflex Capsules revenues; 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; failure to comply with regulatory requirements could result in adverse action by regulatory agencies; and the ability to obtain additional financing to support our operations. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities & Exchange Commission. Acorda may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this presentation are made only as of the date hereof, and Acorda disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this presentation.
February 13, 2014 2ACOR 2013 Q4/Year-End Earnings
![Page 3: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/3.jpg)
Agenda
• 2013 Milestones• AMPYRA® Update• PLUMIAZ™(Diazepam Nasal Spray) Update • Product Development Update• Financial Results/2014 Guidance
3February 13, 2014 ACOR 2013 Q4/Year-End Earnings
![Page 4: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/4.jpg)
4
2013 Milestones
Two new U.S. AMPYRA patents issued, with a third allowed, and successfully defended a European patent against opposition
Filed NDA for PLUMIAZTM (Diazepam Nasal Spray)
Announced positive Phase 2 data for dalfampridine in post-stroke walking deficits
Acquired neuropathic pain assets: QUTENZA® and NP-1998
Initiated second Phase 1 trial of GGF2 in heart failure
Initiated Phase 1 trial of rHIgM22 in multiple sclerosis
Initiated Phase 2 trial of AC105 acute spinal cord injury
ACOR 2013 Q4/Year-End EarningsFebruary 13, 2014
![Page 5: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/5.jpg)
AMPYRA Commercial Update
![Page 6: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/6.jpg)
AMPYRA Commercial Update
• Q4 2013 net revenue $84.6 million• Full year 2013 net revenue $302.6 million
– ~13.7% growth compared to full-year 2012
6February 13, 2014 ACOR 2013 Q4/Year-End Earnings
0
50
100
150
200
250
300
350
2010 2011 2012 2013
$133.1*
$210.5
$ M
$266.1$302.6
* Ten months, Mar-Dec ‘10
![Page 7: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/7.jpg)
AMPYRA Intellectual Property
• 4 Orange Book patents providing protection to 2027• Fifth patent allowed in 2013, awaiting issuance
• Additional applications pending • Orphan exclusivity until 2017• In November 2013, successfully defended an existing
European patent against opposition
7February 13, 2014 ACOR 2013 Q4/Year-End Earnings
![Page 8: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/8.jpg)
PLUMIAZ ™(Diazepam Nasal
Spray)
![Page 9: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/9.jpg)
PLUMIAZ (Diazepam Nasal Spray)
• Potential launch in 2014- Proposed labeling: treatment for increased bouts of
seizure activity (“cluster seizures”)- 505(b)(2) based on Diastat (diazepam rectal gel)
• Exclusivity- Orphan drug: 7 years- Issued U.S. patent to 2029
• Leverages existing commercial infrastructure
9ACOR 2013 Q4/Year-End EarningsFebruary 13, 2014
![Page 10: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/10.jpg)
Cluster Seizures: U.S. Epidemiology
~2,300,000people with active
epilepsy
~2,300,000people with active
epilepsy
~760,000people with treatment-
resistant epilepsy
~760,000people with treatment-
resistant epilepsy
~175,000people with cluster
seizures
~175,000people with cluster
seizures
~1/3
Treatment-resistant
10
Source: Martinez C et al; "Prevalence of Acute Repetitive Seizures (ARS) in the United Kingdom." Epilepsy Research; V.87; 2009
ACOR 2013 Q4/Year-End EarningsFebruary 13, 2014
![Page 11: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/11.jpg)
Pipeline Update
![Page 12: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/12.jpg)
Dalfampridine-QD in Post-Stroke Walking Deficits
• FDA meeting in December 2013 – Integrating design recommendations into Phase 3 protocol
• Phase 3 study planned to begin Q2 2014– Multidose PK study of QD formulation study analysis completed – Pending FDA agreement on final protocol
• Key design elements– Parallel group study comparing 2 doses to placebo– Walking as primary endpoint – Interim analysis – potentially accelerates second Phase 3 study
February 13, 2014 ACOR 2013 Q4/Year-End Earnings 12
![Page 13: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/13.jpg)
NP-1998
• Prescription-strength liquid capsaicin formulation
- Applied to affected area using an applicator
• Phase 2 PHN study: single 5-minute application provided up to 3 months of pain relief
• Potential to treat multiple neuropathies
• Three U.S. patent extending to 2027
ACOR 2013 Q4/Year-End EarningsFebruary 13, 2014 13
![Page 14: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/14.jpg)
Pipeline
• rHIgM22 Phase 1b trial in MS remyelination ongoing• GGF2 second Phase 1b trial enrollment paused pending
review of additional preclinical data• AC105 Phase 2 trial in acute spinal cord injury ongoing
14February 13, 2014 ACOR 2013 Q4/Year-End Earnings
![Page 15: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/15.jpg)
Financial Results and 2014 Guidance
![Page 16: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/16.jpg)
Financial Summary
($ in millions)
12/31/2013 12/31/2012 12/31/2013 12/31/2012
Cash, cash equivalents, short and long-term investments $367.2 $333.2 $367.2 $333.2
Net Ampyra revenue $84.6 $72.7 $302.6 $266.1
Zanaflex branded/authorized generic revenue $1.4 $2.7 $7.3 $16.3
Royalty revenue $4.0 $3.8 $17.1 $14.4
Total revenues $92.6 $81.5 $336.4 $305.8
Total operating expenses $79.8 $80.1 $306.1 $280.2
Non-GAAP net income $13.3 $9.8 $42.6 $50.3
Quarter Ended Full Year
This slide contains GAAP and non-GAAP financial measures. Non-GAAP net income excludes certain items. Information regarding our useof non-GAAP measures, a description of excluded items, and a reconciliation of those measures to GAAP is available in our fourth quarter 2013 financial results press release, which is now available in the investor relations section of our website at www.acorda.com.
16ACOR 2013 Q4/Year-End EarningsFebruary 13, 2014
![Page 17: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/17.jpg)
2014 Financial Guidance
• AMPYRA U.S. net sales: $328-$335 million
• FAMPYRA® & ZANAFLEX® revenue: ~$25 million
• R&D: $60-$70 million*
• SG&A: $180-$190 million*
* non-GAAP figures
February 13, 2014 ACOR 2013 Q4/Year-End Earnings 17
![Page 18: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/18.jpg)
2014 Priorities
• AMPYRA sales $328-$335 million• Initiate dalfampridine-QD post-stroke
Phase 3 study• Potential PLUMIAZ approval/launch• NP-1998 development• Build additional value through asset acquisitions
February 13, 2014 ACOR 2013 Q4/Year-End Earnings 18
![Page 19: Acorda 2013 Fourth Quarter/ Full Year Earningss1.q4cdn.com/271808180/files/doc_presentations/ACOR...successfully market Fampyra outside of the U.S. and our dependence on our collaboration](https://reader034.fdocuments.net/reader034/viewer/2022050610/5fb18130e50066621562d686/html5/thumbnails/19.jpg)
Acorda 2013 Fourth Quarter/Full Year EarningsFebruary 13, 2014