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CORRECTING and REPLACING Acorda Provides Financial and Pipeline Update for First Quarter 2017

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Thursday, April 27th 2017 at 11:15am UTC
  • Corporate restructuring implemented to focus on late-stage Parkinson’s
    programs
  • 2017 combined R&D and SG&A operating expense guidance revised to $330
    – $350 million, a reduction of ~$50 million
  • Projected year-end cash balance greater than $200 million
  • AMPYRA® (dalfampridine) 1Q 2017 net revenue of
    $112.0 million; Company reiterates AMPYRA net sales guidance of $535 –
    $545 million

ARDSLEY, N.Y.–(BUSINESS WIRE)– Footnote 5 beneath Non-GAAP Income and Income per Common Share
Reconciliation table should read: Represents the tax effect of the
non-GAAP adjustments.

The corrected release reads: 

ACORDA PROVIDES FINANCIAL AND PIPELINE UPDATE FOR FIRST QUARTER 2017

  • Corporate restructuring implemented to focus on late-stage Parkinson’s
    programs
  • 2017 combined R&D and SG&A operating expense guidance revised to $330
    – $350 million, a reduction of ~$50 million
  • Projected year-end cash balance greater than $200 million
  • AMPYRA® (dalfampridine) 1Q 2017 net revenue of
    $112.0 million; Company reiterates AMPYRA net sales guidance of $535 –
    $545 million

Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced financial results for its first quarter ended March 31,
2017, and provided an update on the Company’s pipeline, financial
guidance and corporate restructuring.

As previously announced, following the decision by the United States
District Court for the District of Delaware invalidating certain patents
pertaining to AMPYRA®, Acorda implemented a corporate
restructuring to reduce its cost structure and focus resources on its
late-stage Parkinson’s disease programs, CVT-301 and tozadenant. The
proposed brand name for CVT-301 is INBRIJA™ (levodopa inhalation
powder). The Company expects to maintain exclusivity of AMPYRA at least
through July 2018 and plans to appeal the ruling on the invalidated
patents.

“We acted decisively to reduce expenses within days of the Court’s
ruling. Moving forward, we will focus on advancing our late-stage
Parkinson’s programs, INBRIJA and tozadenant,” said Ron Cohen, M.D.,
Acorda’s President and CEO. “Our restructuring will enable us to execute
these programs on a strong financial footing, and we are confident in
the value we will be able to create for shareholders.”

Acorda’s top priorities over the next 12 months are to:

  • Submit a New Drug Application (NDA) for INBRIJA to the U.S. Food and
    Drug Administration (FDA) in the second quarter of 2017 and submit the
    Marketing Authorization Application (MAA) to the European Medicines
    Agency (EMA) by the end of 2017.
  • Plan for commercialization and launch of INBRIJA in the United States.
  • Complete the tozadenant Phase 3 study (TOZ-CL-05), with topline
    results in the first quarter of 2018.
  • Maximize AMPYRA value and ensure continued patient access.

First Quarter 2017 Financial Results

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg – For
the quarter ended March 31, 2017, the Company reported AMPYRA net
revenue of $112.0 million, up 2% compared to $109.6 million for the same
quarter in 2016.

ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules – For
the quarter ended March 31, 2017, the Company reported combined net
revenue and royalties from ZANAFLEX and tizanidine of $1.7 million,
compared to $1.2 million for the same quarter in 2016.

FAMPYRA® (prolonged-release fampridine tablets) – For the
quarter ended March 31, 2017, the Company reported FAMPYRA royalties
from sales outside of the U.S. of $2.5 million, compared to $2.5 million
for the same quarter in 2016.

Research and development (R&D) expenses for the quarter ended March 31,
2017 were $46.5 million, including $2.5 million of share-based
compensation, compared to $44.6 million, including $2.1 million of
share-based compensation, for the same quarter in 2016.

Selling, general and administrative (SG&A) expenses for the quarter
ended March 31, 2017 were $51.7 million, including $5.3 million of
share-based compensation, compared to $51.8 million, including $6.0
million of share-based compensation, for the same quarter in 2016.

Benefit from income taxes for the quarter ended March 31, 2017 was $0.9
million, compared to $9.7 million, for the same quarter in 2016.

The Company reported a GAAP net loss of $18.9 million for the quarter
ended March 31, 2017, or $0.41 per diluted share. The GAAP net loss in
the same quarter of 2016 was $0.5 million, or $0.01 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2017 was $3.6 million,
or $.08 per diluted share. Non-GAAP net income in the same quarter of
2016 was $12.4 million, or $0.27 per diluted share. This quarterly
non-GAAP net income measure, more fully described below under “Non-GAAP
Financial Measures,” excludes share-based compensation charges,
unrealized foreign currency gain, non-cash interest charges on our debt,
changes in the fair value of acquired contingent consideration, and
acquisition-related expenses. A reconciliation of the GAAP financial
results to non-GAAP financial results is included with the attached
financial statements.

At March 31, 2017, the Company had cash and cash equivalents of $133.6
million. The Company has $345 million of convertible senior notes due in
2021 with a conversion price of $42.56.

Corporate Restructuring and 2017 Guidance Update

Following the decision by the United States District Court for the
District of Delaware invalidating certain patents pertaining to AMPYRA,
Acorda implemented a corporate restructuring to reduce its cost
structure and focus resources on its late-stage Parkinson’s disease
programs, INBRIJA and tozadenant.

  • Corporate Restructuring
    • The company reduced personnel and non-personnel related expenses
      in 2017, resulting in a total reduction of 2017 expenses of
      approximately $50 million.
    • The operating expense reductions will enable the Company to fund
      operations through key milestones for its late-stage development
      programs, including the launch of INBRIJA in the United States and
      topline data from the tozadenant Phase 3 efficacy study in the
      first quarter of 2018.
  • Revised Guidance for 2017
    • The Company reiterates AMPYRA net sales guidance of $535 – $545
      million.
    • Combined 2017 R&D and SG&A operating expense guidance reduced from
      $380 – $400 million to $330 – $350 million, a reduction of ~$50
      million. This guidance is a non-GAAP projection that excludes
      share-based compensation and restructuring costs, as more fully
      described below under “Non-GAAP Financial Measures.”
    • The Company expects to be cash flow positive in 2017, with a
      projected year-end cash balance in excess of $200 million. The
      Company expects a similar year-end 2018 cash balance based on its
      current internal assumptions for 2018 AMPYRA revenue projections.

Pipeline and Corporate Developments

  • AMPYRA (dalfampridine)
    • In March, the United States District Court for the District of
      Delaware upheld U.S. Patent No. 5,540,938 (the ‘938 patent), which
      is set to expire July 30, 2018. The Court invalidated four patents
      pertaining to AMPYRA that were set to expire between 2025 and 2027.
    • Based on the District Court ruling, Acorda expects to maintain
      exclusivity of AMPYRA through July 2018; the Company will appeal
      the ruling on the invalidated patents.
    • In March, the United States Patent and Trademark Office (USPTO)
      Patent Trials and Appeal Board (PTAB) upheld all four patents
      challenged via the inter partes review (IPR) process.
  • INBRIJA in Parkinson’s disease
    • In March, the Company announced results from two ongoing,
      long-term safety studies of INBRIJA in people with Parkinson’s.
    • Based on the results of the Phase 3 efficacy study and the two
      long-term safety studies, the Company plans to file an NDA with
      the FDA in the second quarter of 2017.
    • Data from the Phase 3 efficacy study (Study 004) has been accepted
      as a late-breaker at the International Congress of Parkinson’s
      Disease and Movement Disorders (MDS), taking place in Vancouver,
      BC June 4-8, 2017.
  • Tozadenant in Parkinson’s disease
    • In April, the first patient in the TOZ-CL-06 Phase 3 long-term
      safety study was randomized and began receiving study medication.
    • The ongoing tozadenant Phase 3 safety and efficacy study
      (TOZ-CL-05) is expected to report topline results in 1Q 2018.
  • CVT-427 in Acute Migraine
    • In December, we completed a special population study to evaluate
      safe inhalation in people with asthma and in smokers.
    • Some subjects showed evidence of acute, reversible
      bronchoconstriction, post-inhalation.
    • We are evaluating next steps for the program and CVT-427 will not
      advance into a Phase 2 study by the end of 2017, as previously
      expected.
  • Board of Directors
    • Effective February 17, 2017, Catherine D. Strader, Ph.D. joined
      Acorda’s Board of Directors. Dr. Strader assumed a newly-added
      Board seat and will be up for election in 2018.

Webcast and Conference Call

Acorda will host a conference call today at 8:30 a.m. ET to review first
quarter 2017 results. To participate, dial (844) 543-5233 (domestic) or
(678) 276-7225 (international) and reference the access code 1387861.
The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on April 27,
2017 until 11:59 p.m. ET on May 4, 2017. To access the replay, please
dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and
reference the access code 1387861. The archived webcast will be
available in the Investor Relations section of the Acorda website.

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biopharmaceutical company
focused on developing therapies that restore function and improve the
lives of people with neurological disorders. Acorda has a pipeline of
novel neurological therapies addressing a range of disorders, including
Parkinson’s disease, migraine and multiple sclerosis. Acorda markets
three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg. For more information, please visit the Company’s
website at: www.acorda.com.

Forward-Looking Statement

These statements 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
Biotie’s 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 INBRIJA (our trade name for 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
INBRIJA, any other products under development, or the products that we
acquired with 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.

These and other risks are described in greater detail in our filings
with the Securities and Exchange Commission. We may not actually achieve
the goals or plans described in our forward-looking statements, and
investors should not place undue reliance on these statements.
Forward-looking statements made in this press release are made only as
of the date hereof, and we disclaim any intent or obligation to update
any forward-looking statements as a result of developments occurring
after the date of this press release.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance
with accounting principles generally accepted in the United States
(GAAP), and also certain historical and forward-looking non-GAAP
financial measures. In particular, Acorda has provided non-GAAP net
income, adjusted to exclude the items below, and has provided 2017
guidance for R&D and SG&A on a non-GAAP basis. Non-GAAP financial
measures are not an alternative for financial measures prepared in
accordance with GAAP. However, the Company believes the presentation of
non-GAAP net income, when viewed in conjunction with our GAAP results,
provides investors with a more meaningful understanding of our ongoing
and projected operating performance because this measure excludes (i)
non-cash charges and benefits that are substantially dependent on
changes in the market price of our common stock, (ii) non-cash interest
charges related to the accounting for our outstanding convertible debt
which are in excess of the actual interest expense owing on such
convertible debt as well as non-cash interest charges related to our
asset based loan and acquired Biotie debt, (iii) changes in the fair
value of acquired contingent consideration which do not correlate to our
actual cash payment obligations in the relevant period, (iv) unrealized
foreign currency gain related to the Biotie acquisition, (v) acquisition
related expenses that pertain to a non-recurring event, and (vi)
corporate restructuring expenses that pertain to a non-recurring event.
The Company believes its non-GAAP net income measure helps indicate
underlying trends in the Company’s business and is important in
comparing current results with prior period results and understanding
projected operating performance. Also, management uses this non-GAAP
financial measure to establish budgets and operational goals, and to
manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income, we have provided revised 2017
guidance for R&D and SG&A on a non-GAAP basis. Due to the forward
looking nature of this information, the amount of compensation charges
and benefits needed to reconcile these measures to the most directly
comparable GAAP financial measures is dependent on future changes in the
market price of our common stock and is not available at this time. The
Company believes that these non-GAAP measures, when viewed in
conjunction with our GAAP results, provide investors with a more
meaningful understanding of our ongoing and projected R&D and SG&A
expenses. Also, management uses these non-GAAP financial measures to
establish budgets and operational goals, and to manage the Company’s
business and to evaluate its performance.

Financial Statements

 

Acorda Therapeutics, Inc.
Condensed Consolidated
Balance Sheet Data

(in thousands)
(unaudited)

 
      March 31,     December 31,
2017 2016
 
Assets
Cash, cash equivalents and short-term investments $ 133,619 $ 158,537
Trade receivable, net 50,238 52,239
Other current assets 18,241 18,746
Finished goods inventory 46,054 43,135
Deferred tax asset 4,400 4,400
Property and equipment, net 37,132 34,310
Goodwill 278,069 280,599
Intangible assets, net 740,838 742,242
Other assets   11,251   8,127
Total assets $ 1,319,842 $ 1,342,335
 
Liabilities and stockholders’ equity
Accounts payable, accrued expenses and other current liabilities $ 109,524 $ 131,823
Current portion of deferred license revenue 9,057 9,057
Current portion of loans payable 754 6,256
Current portion of notes payable 765
Convertible senior notes 301,706 299,395
Contingent consideration 82,900 72,100
Non-current portion of deferred license revenue 30,191 32,456
Non-current portion of loans payable 24,660 24,635
Deferred tax liability 76,130 92,807
Other long-term liabilities 8,793 8,830
Total stockholder’s equity   676,127   664,211
Total liabilities and stockholders’ equity $ 1,319,842 $ 1,342,335
 
 

Acorda Therapeutics, Inc.
Consolidated Statements
of Operations

(in thousands, except per share amounts)
(unaudited)

 
      Three Months Ended
March 31,
2017     2016
 
Revenues:
Net product revenues $ 112,593 $ 110,148
Royalty revenues 4,528 3,492
License revenue   2,265     2,264  
Total revenues 119,386 115,904
 
Costs and expenses:
Cost of sales 25,183 23,186
Cost of license revenue 159 159
Research and development 46,493 44,570
Selling, general and administrative 51,704 51,782
Acquisition related expenses 320 7,198

Change in fair value of acquired contingent consideration

  10,800     6,200  
Total operating expenses 134,659 133,095
   
Operating loss $ (15,273 ) $ (17,191 )
 
Other (expense) income, net   (4,549 )   6,934  
Loss before income taxes (19,822 ) (10,257 )
Benefit from income taxes   918     9,737  
Net loss $ (18,904 ) $ (520 )
 
Net loss per common share – basic $ (0.41 ) $ (0.01 )
Weighted average per common share – basic 45,808 44,815
 
 

Acorda Therapeutics, Inc.
Non-GAAP Income and
Income per Common Share Reconciliation

(in thousands,
except per share amounts)

(unaudited)

 
      Three Months Ended
March 31,
2017   2016
 
GAAP net loss $ (18,904 ) $ (520 )
Pro forma adjustments:
Non-cash interest expense (1) 2,580 2,204
 

Change in fair value of acquired contingent consideration (2)

10,800 6,200
 
Acquisition related expenses (3) 567 7,198
 
Unrealized foreign currency gain (4) (10,289 )
 

Share-based compensation expenses included in R&D

2,536 2,121

Share-based compensation expenses included in SG&A

  5,336     6,038  

Total share-based compensation expenses

7,872 8,159
   
Total pro forma adjustments 21,819 13,472
 

Income tax effect of reconciling items above (5)

6,502 554
   
Non-GAAP net (loss) income (6) $ (3,587 ) $ 12,398  
 
Net (loss) income per common share – basic $ (0.08 ) $ 0.28
Net (loss) income per common share – diluted $ (0.08 ) $ 0.27
Weighted average per common share – basic 45,808 44,815
Weighted average per common share – diluted 45,808 46,043
 
(1)   Non-cash interest expense related to convertible senior notes, asset
based loan, and Biotie non-convertible and R&D loans.
(2) Changes in fair value of acquired contingent consideration related
to Civitas transaction.
(3) Transaction expenses related to the Biotie acquisition, inclusive of
$0.2 million of realized foreign currency loss.
(4) Unrealized foreign currency transaction gain related to the Biotie
acquisition.

(5)

Represents the tax effect of the non-GAAP adjustments.

(6)

Prior year non-GAAP adjustments included a separate income tax
expense adjustment from GAAP tax expense to the amount of cash taxes
paid or payable for the respective period. As of March 31, 2017, the
presentation includes the tax effect of the non-GAAP adjustments as
prescribed by the updated Compliance and Disclosure Interpretations
issued by the SEC in May, 2016. In the three months ended March 31,
2017 and 2016, cash taxes paid were $1.9 million and $0.2 million,
respectively. A reconciliation to the previously reported non-GAAP
results is presented below.
 
     

Three
Months
Ended

March 31,
2016
Non-GAAP net income – as revised (see above) $ 12,398
Income tax effect of the reconciling items (see above) 554
Non-cash income taxes (as previously reported)   (9,894 )
Non-GAAP net income (as previously reported) $ 3,058  
 

Note: Non-GAAP net income per share basic and diluted as presented above
were also revised as a result of the changes to the income tax effect of
the non-GAAP adjustments as noted above.

Contacts

Acorda Therapeutics, Inc.
Felicia Vonella, 914-326-5146
fvonella@acorda.com

Source: Acorda Therapeutics, Inc.

Cet article CORRECTING and REPLACING Acorda Provides Financial and Pipeline
Update for First Quarter 2017
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