On February 15, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2017 and recent corporate developments (Press release, Genocea Biosciences, FEB 15, 2018, View Source [SID1234524004]).

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"We’ve had a productive start to 2018 and are encouraged by both the progress with our lead neoantigen cancer vaccine, GEN-009, and the broader application of our ATLAS technology to cancer," said Chip Clark, president and chief executive officer of Genocea. "Notably, we believe that our $55 million financing suggests a strong endorsement of our technology, our corporate strategy, and our team. We continue to advance GEN-009, bringing us very close to filing our first cancer vaccine IND. We are also continuing to explore partnership opportunities for our ATLAS platform, a technology that we believe uniquely differentiates us from our peers as the only platform to identify true T cell antigens, which we anticipate will result in more effective cancer vaccines."

Recent Milestones & Events

November 2017: At the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2017), Genocea presented data demonstrating the power and versatility of its ATLAS platform and its potential superiority to in silico methods of neoantigen identification, as well as data highlighting the discovery of unexpected and novel T cell antigens for vaccines against colorectal cancer and non-small cell lung cancer.
January 2018: Genocea announced completion of a $55 million financing, including significant investments by New Enterprise Associates (NEA) and Vivo Capital (Vivo).
January 2018: The U.S. Patent and Trademark Office issued an allowance on United States Patent 9,873,870, further strengthening the company’s intellectual property position on its ATLAS platform for the identification and characterization of neoantigens and tumor-associated antigens.
January 2018: Genocea and Oncovir, Inc. entered into a license and supply agreement for Oncovir’s Hiltonol (poly-ICLC) adjuvant, a key component of Genocea’s personalized cancer vaccine candidate, GEN-009.
Anticipated Upcoming Milestones & Events

Q1 2018: The company expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its GEN-009 personalized cancer vaccine.
March 2018: Genocea management is scheduled to present at the Cowen and Company Annual Health Care Conference in Boston (March 12-14), and at the Needham & Co. Annual Healthcare Conference in New York City (March 27-28).
Mid-2018: Genocea plans to initiate a Phase 1/2a clinical trial for GEN-009 in patients with a variety of tumor types. The first part of this trial is expected to enroll 6 patients with no evidence of disease but a high likelihood of relapse. Safety and immunogenicity data will be monitored, with preliminary results expected in the first half of 2019.
Corporate Update and Financial Guidance
In January 2018, Genocea completed a $55 million equity financing, including significant investments from NEA and Vivo. Net proceeds from the equity financing were approximately $51.7 million.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy to treat the large patient population infected with genital herpes, many of whom are dissatisfied with their current treatment options.

In January 2018, Genocea entered into an amendment to its loan agreement with Hercules that provides, at no incremental cost to Genocea, for a deferred principal payment period of 3 months commencing on February 1, 2018. During this time Genocea will continue to make monthly payments of interest. Genocea has initiated a process to restructure or refinance the debt facility to better align repayment of the debt with its new corporate strategy and anticipated clinical milestones. If this process is successful, the company expects to be able to defer certain debt principal payments, thereby reducing expected significant cash payments in 2018 and 2019 relating to the current debt facility.

Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the second half of 2019 without assuming the expected benefit of the restructuring or refinancing of its debt facility.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers and referencing the conference ID number 7396178. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 30 days.

Fourth Quarter 2017 Financial Results

Cash Position: As of December 31, 2017, cash and cash equivalents were $12.3 million compared to $22.0 million as of September 30, 2017.
Research and Development (R&D) Expenses: R&D expenses decreased approximately $3.9 million to $7.9 million for the quarter ended December 31, 2017 from $11.8 million for the same period ended December 31, 2016. The decrease was primarily driven by $6.5 million in reduced GEN-003 costs, as a result of the strategic shift and restructuring announced in September 2017. Decreases in GEN-003 costs were offset by a $3.9 million increase in costs incurred on the Company’s GEN-009 program as it continued to develop its supply chain and manufacturing capabilities to prepare for the planned IND filing and initiation of clinical trials for GEN-009.
General and Administrative (G&A) Expenses: G&A expenses decreased approximately $1.4 million to $2.5 million for the quarter ended December 31, 2017 from $3.9 million for the quarter ended December 31, 2016. The decrease was driven by reduced compensation, consulting and professional service costs, depreciation and facility related costs.
Net Loss: Net loss was $10.7 million for the quarter ended December 31, 2017, compared to a net loss of $16.0 million for the same period in 2016.

Full Year 2017 Financial Results

Cash Position: As of December 31, 2017, cash and cash equivalents were $12.3 million compared to cash, cash equivalents, and investments totaling $63.4 million as of December 31, 2016.

R&D Expenses: R&D expenses increased approximately $4.6 million to $39.2 million for the year ended December 31, 2017 from $34.6 million for the year ended December 31, 2016. On a program basis, GEN-009 and other immuno-oncology costs increased by $9.5 million, driven primarily by increased headcount, consulting and professional service costs, manufacturing and clinical and lab related costs in anticipation of the expected IND filing for GEN-009 in early 2018. GEN-003 costs increased $1.9 million, driven by increased external manufacturing related expenses, headcount and consulting and professional service costs in advance of the previously planned Phase 3 trials, offset by decreased clinical and lab related costs. Increased spending on these programs was offset by lower costs on other infectious disease programs previously deprioritized in 2016.

G&A Expenses: General and administrative expense decreased $2.0 million to $13.4 million for the year ended December 31, 2017 from $15.4 million for the year ended December 31, 2016. Decreases were driven by lower consulting and professional services costs, facility-related costs and depreciation.

Restructuring: As a result of the Company’s strategic shift to immuno-oncology, which was announced in September 2017, restructuring charges of $2.6 million were incurred for employee severance, employee benefits, contract terminations and asset impairment. Of these charges, $1.1 million were paid through December 31, 2017, $0.5 million were recorded as accrued expenses at December 31, 2017 and $1.0 million were non-cash charges recorded during the year ended December 31, 2017.

Net Loss: Net loss was $56.7 million for the year ended December 31, 2017, compared to a net loss of $49.6 million for the year ended December 31, 2016.

On February 15, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported that the Company will release its 2017 fourth quarter and full year financial results on Monday, February 26, 2018, before the market opens (Press release, Eagle Pharmaceuticals, FEB 15, 2018, View Source [SID1234524002]).

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date Monday, February 26, 2018
Time 8:30 a.m. EST
Toll free (U.S.) 866-518-6930
International 203-518-9797
Webcast (live and replay)
www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-677-7320 (US) or 402-220-0666 (International) and entering conference call ID EGRXQ417. The webcast will be archived for 30 days at the aforementioned URL.

On February 15, 2018 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the fourth quarter of 2017. Net loss for the fourth quarter was $40.5 million, or $0.75 per basic share and diluted share, respectively, compared to net income for the same period in 2016 of $7.2 million, or $0.18 and $0.16 per basic and diluted share, respectively (Press release, Cytokinetics, FEB 15, 2018, View Source [SID1234524001]). Cash, cash equivalents and investments totaled $285.4 million at December 31, 2017.

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"We had a productive fourth quarter and begin the year with optimism for our growing pipeline of muscle biology directed drug candidates," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "In 2018, we are looking forward to results from four mid-stage clinical trials of CK-2127107 in our skeletal muscle activator program which may inform plans to advance to a Phase 3 clinical program under our collaboration with Astellas. Additionally, enrollment in GALACTIC-HF remains on track with planning under our collaboration with Amgen. Our research continues to power innovation with two potential drug candidates expected to move through IND-enabling studies and into Phase 1 trials in 2018."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil (cardiac myosin activator)

Continued site activation and patient enrollment in GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment is proceeding according to plan with patients that have the intended risk profile consistent with the trial design.

Continued protocol development, feasibility assessments, regulatory interactions and other readiness activities for a second Phase 3 clinical trial of omecamtiv mecarbil. This trial which is intended to evaluate the potential of omecamtiv mecarbil to increase exercise performance in patients with heart failure is planned to be conducted by Cytokinetics in collaboration with Amgen.

Announced that a post-hoc responder analysis from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, was presented by John Teerlink, M.D. in an Abstract Rapid Fire Oral presentation at the American Heart Association Scientific Sessions. The proportion of patients achieving various thresholds in the percent reduction of NT-proBNP was larger in patients who received omecamtiv mecarbil than in patients who received placebo.
Skeletal Muscle Program

tirasemtiv (fast skeletal muscle troponin activator (FSTA))

Announced the presentation of results from VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), the international Phase 3 clinical trial of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS), at the 28th International Symposium on ALS and Motor Neurone Disease (MND) in Boston. The presentation, by Jeremy Shefner, M.D., Ph.D., Lead Investigator of VITALITY-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at University of Arizona, Phoenix, followed our prior announcement that the trial did not meet the primary endpoint of change from baseline in slow vital capacity which was evaluated at 24 weeks following randomization or any of the secondary endpoints in the trial which were evaluated at 48 weeks.

Continued treatment of patients in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label clinical trial designed to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who have completed participation in VITALITY-ALS. Currently, there are still over 100 patients who are receiving tirasemtiv in VIGOR-ALS.
CK-2127107, reldesemtiv (next-generation fast skeletal muscle troponin activator)

Received final approval from the World Health Organization and the United States Adopted Name Council for reldesemtiv to be used as the International Nonproprietary Name for CK-2127107.

Continued conduct of our Phase 2 clinical trial of reldesemtiv which is designed to assess its effect on multiple measures of muscle function in both ambulatory and non-ambulatory patients with SMA. This trial has enrolled over 60 patients toward the objective of 72 patients and is being conducted by Cytokinetics in collaboration with Astellas.

Continued site activation and patient enrollment in FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv which is designed to assess the change from baseline in the percent predicted slow vital capacity (SVC) and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This trial has screened over 100 patients and enrolled nearly 90 patients toward the objective of 445 patients and is being conducted by Cytokinetics in collaboration with Astellas.

Continued site activation and patient enrollment in the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD) which is designed to assess its effect on physical function. This trial has enrolled over 30 patients towards the objective of 40 patients and is being conducted by Astellas in collaboration with Cytokinetics.

Continued site activation and patient enrollment in the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility which is designed to assess its effect on measures of physical function. This trial has enrolled over 20 subjects towards the objective of 60 subjects and is being conducted by Astellas in collaboration with Cytokinetics.

Announced the publication of "CK-2127107 Amplifies Skeletal Muscle Response to Nerve Activation in Humans," in Muscle & Nerve, which showed that reldesemtiv increased the force generated by the tibialis anterior muscle versus placebo in response to nerve stimulation in a dose, plasma concentration, and frequency-dependent manner. Single doses of reldesemtiv were well-tolerated in healthy volunteers up to 4000 mg. No serious adverse events were reported and adverse events were all mild or moderate.
Pre-Clinical Research and Development

Advanced a next-generation cardiac muscle activator into development under our collaboration with Amgen. This milestone triggered a $1 million payment from Amgen to Cytokinetics.

Advanced a next-generation skeletal muscle activator into development under our collaboration with Astellas.

Announced that Cytokinetics is advancing an unpartnered cardiac sarcomere directed compound from research into IND-enabling studies in 2018.

Continued collaboration activities under our joint research program with Amgen directed to the discovery of next-generation cardiac muscle activators and under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators. Cytokinetics and Astellas recently agreed to extend the joint research program through 2019.

Company scientists continued independent research activities directed to our other muscle biology programs.
Financials

Revenues for the year ended December 31, 2017 included $11.0 million in milestone revenues from Amgen as well as $1.3 million of research and development revenues from our collaboration with Amgen, and $11.9 million of research and development revenues plus $8.8 million of license revenues from our collaboration with Astellas. Revenues for the year ended December 31, 2017 were offset by $20.0 million (out of the total of $40 million) for payments to Amgen related to our option to co-fund the Phase 3 development program of omecamtiv mecarbil in exchange for an increased royalty upon potential commercialization. Revenues in 2016 were primarily due to license revenue from the September 2016 expansion of our collaboration with Astellas and a $26.7 million milestone payment from Amgen.

Research and development expenses for the three months and year ended December 31, 2017 increased to $26.3 million and $90.3 million, respectively, from $18.8 million and $59.9 million for the same periods in 2016, primarily due to increased clinical activity, including activity for VITALITY-ALS, increased clinical trials activity for reldesemtiv, as well as increased personnel.

General and administrative expenses for the three months and year ended December 31, 2017 increased to $10.3 million and $36.5 million, respectively, from $6.7 million and $27.8 million for the same periods in 2016, primarily due to increased personnel, non-cash stock compensation expense and commercial readiness activities.

2018 Financial Guidance

The Company also announced financial guidance for 2018. The company anticipates cash revenue will be in the range of $17 to $23 million, operating expenses will be in the range of $105 to $115 million, and net cash utilization will be approximately $100 million.

2018 Corporate Milestones

Cardiac Muscle Program

omecamtiv mecarbil (cardiac myosin activator)

Expect to complete enrolling patients with chronic heart failure in GALACTIC-HF in approximately one year.

Expect to finalize plans and prepare to start the second Phase 3 trial of omecamtiv mecarbil.
Skeletal Muscle Program

CK-2127107 (reldesemtiv), (next-generation fast skeletal muscle troponin activator (FSTA))

Expect results from a Phase 2 clinical trial of reldesemtiv in patients with SMA in Q2 2018.

Expect results from a Phase 2 clinical trial of reldesemtiv in patients with ALS in 2H 2018.

Expect results from a Phase 2 clinical trial of reldesemtiv in patients with COPD in 2H 2018.

Expect results from a Phase 1b clinical trial of reldesemtiv in adults with limited mobility in 2H 2018.
Pre-Clinical Research

Expect to advance one development compound, under each of our collaborations with Amgen and Astellas, into IND-enabling studies in 2018, one of which may proceed to Phase 1 this year.

Expect to advance an unpartnered cardiac sarcomere directed compound through IND-enabling studies in 2018 to enable initiation of Phase 1 in 2018.
Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 3665278.

An archived replay of the webcast will be available via Cytokinetics’ website until February 22, 2018. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 3665278 from February 15, 2018 at 7:30 PM Eastern Time until February 22, 2018.

On February 15, 2018 Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that Steven Klosk, President and Chief Executive Officer, will participate in a fireside chat at the 2018 RBC Capital Markets Global Healthcare Conference on February 22, 2018 at 3:05 p.m. EST in New York City (Press release, Cambrex, FEB 15, 2018, View Source [SID1234524000]).

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The live audio webcast and slide presentation can be accessed from the Cambrex website at www.cambrex.com in the Investors section under "Webcasts & Presentations", and a replay will be available for 90 days after the live event concludes.

On February 15, 2018 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial and pipeline update for the fourth quarter and full year ended December 31, 2017 (Press release, Acorda Therapeutics, FEB 15, 2018, View Source [SID1234523995]).

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"We continue to prepare for the potential approval and launch of INBRIJA, our investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease. We look forward to working with the FDA during the NDA review process, and to bringing this new treatment option to the Parkinson’s community to help address an important unmet need," said Ron Cohen, M.D., Acorda’s President and CEO. "Based on our continued market research, as well as the strength of our Phase 3 data, we believe INBRIJA’s US market opportunity to be greater than $800 million."

Fourth Quarter 2017 Financial Results

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended December 31, 2017, the Company reported AMPYRA net revenue of $167.2 million compared to $132.3 million for the same quarter in 2016.

Royalty Revenue – For the quarter ended December 31, 2017, the Company reported royalty revenue of $16.1 million as compared to $4.4 million for the same quarter in 2016. The Company reported FAMPYRA royalties from sales outside of the U.S. of $3.1 million compared to $2.7 million for the same quarter in 2016. Additionally, the Company completed a transaction that provides a fully paid-up, royalty-free license for Selincro in exchange for $13.0 million which was recorded as royalty revenue in the quarter ended December 31, 2017. During the quarter ended December 31, 2017, the Company completed a royalty purchase transaction for its Fampyra royalty revenue in exchange for an upfront payment of $40 million. The transaction was recorded as a liability in accordance with US GAAP which will be reduced over time as royalty revenue is recognized.

Research and development (R&D) expenses for the quarter ended December 31, 2017 were $35.1 million, including $2.2 million of share-based compensation compared to $53.8 million, including $3.0 million of share-based compensation for the same quarter in 2016.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2017 were $39.5 million, including $5.4 million of share-based compensation compared to $59.0 million, including $6.0 million of share-based compensation for the same quarter in 2016.

The Company recorded non-cash asset impairment charges of $233.5 million for tozadenant as a result of the termination of this program, and $23.8 million for SYN120 as a result of the trial not meeting key primary and secondary endpoints. The Company assessed the valuation assumptions for both programs and determined the assets were fully impaired. Both of these charges were recorded in the quarter ended December 31, 2017.

Benefit from income taxes for the quarter ended December 31, 2017 was $51.9 million, including $2.7 million of cash taxes, compared to a provision for income taxes of $1.0 million, including $0.7 million of cash taxes for the same quarter in 2016.

The Company reported a GAAP net loss attributable to Acorda of $(171.1) million for the quarter ended December

31, 2017, or $(3.70) per diluted share. GAAP net loss in the same quarter of 2016 was $(3.1) million, or $(0.07) per diluted share.

Non-GAAP net income for the quarter ended December 31, 2017 was $28.5 million, or $0.61 per diluted share. Non-GAAP net income in the same quarter of 2016 was $2.5 million, or $0.05 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Financial Results – Full Year Ended December 31, 2017

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the full year ended December 31, 2017 net revenue was $543.3 million compared to $492.8 million for full year 2016. Full year 2017 net revenue increased 10.2% over 2016.

Royalty Revenue – For the full year ended December 31, 2017, the Company reported royalty revenue of $29.5 million compared to $17.2 million for the full year 2016. The Company reported FAMPYRA royalties from sales outside of the U.S. of $11.6 million compared to $10.6 million for the full year 2016. Royalty revenue related to the authorized generic version of Zanaflex was $2.6 million compared to $3.9 million for the full year 2016. Additionally, the Company reported $15.3 million in royalties for Selincro for the full year 2017, which includes $13.0 million of royalty revenue related to the Selincro royalty transaction.

Research and development (R&D) expenses for the full year ended December 31, 2017 were $166.1 million, including $9.7 million of share-based compensation, compared to $203.4 million, including $10.6 million of share-based compensation for the full year 2016

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2017 were $181.6 million, including $23.1 million of share-based compensation, compared to $235.4 million, including $25.8 million of share-based compensation for the full year 2016.

Asset impairment charges for the full year ended December 31, 2017 include $233.5 million for tozadenant, $23.8 million for SYN120, and $39.4 million for Selincro.

Benefit from income taxes for the full year ended December 31, 2017 was $28.5 million, including $14.1 million of cash taxes compared to a benefit from income taxes of $6.7 million, including $4.3 million of cash taxes for the full year 2016.

For the full year ended December 31, 2017, the Company reported a GAAP net loss of $(223.4) million, or $(4.86) per diluted share. GAAP net loss for the full year 2016 was $(34.6) million, or $(0.76) per diluted share.

Non-GAAP net income for the full year ended December 31, 2017 was $80.7 million, or $1.75 per diluted share. Non-GAAP net income for the full year ended December 31, 2016 was $11.5 million, or $0.25 per diluted share. This full year non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets, realized foreign currency loss (gain) and acquisition related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2017, the Company had cash and cash equivalents of $307.1 million.

2018 Financial Guidance

AMPYRA net revenue is expected to be $330-$350 million. The Company expects to maintain exclusivity of AMPYRA at least through July 30, 2018; this guidance is subject to change based on the appellate court’s decision.

R&D expenses for the full year 2018 are expected to be $100-$110 million and include manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."

SG&A expenses for the full year 2018 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Year-end cash balance for 2018 is projected to be over $300 million

Fourth Quarter 2017 Pipeline and Corporate Updates

INBRIJA (levodopa inhalation powder) Next Steps

The Company resubmitted the NDA for INBRIJA in December 2017. The FDA is expected to inform the Company if the submission has been deemed complete and permits a full review in February 2018.

The Company expects to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in Q1 2018.

AMPYRA (dalfampridine) Patent Appeal

In November, 2017, the Company and the defendants filed reply briefs for the appeal to the U.S. Court of Appeals for the Federal Circuit of the District Court’s decision in the AMPYRA patent litigation. The date for oral argument is expected in the first half of 2018.

Both BIO and PhRMA filed amicus briefs in support of the Company’s appeal, raising important issues in conjunction with biopharmaceutical innovation.

Royalty Monetization Transactions/ZANAFLEX (tizanidine hydrochloride) Franchise Sale

In November, 2017, the Company announced royalty monetization transactions of $53 million for FAMPYRA and SELINCRO.

The Company also announced the sale of ZANAFLEX and ZANAFLEX CAPSULES for $4 million.

SYN120 Phase 2 Data in Parkinson’s disease

Data from the Phase 2 proof-of-concept study for SYN120 showed that several of the outcome measures trended in favor of drug versus placebo; neither the primary nor key secondary endpoints achieved statistical significance.

The Company continues to review the data, which will be presented at an upcoming medical meeting.

Tozadenant Program Discontinued

In November, 2017, the Company discontinued its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease. The Company made this decision based on the emergence of serious adverse events in its Phase 3 program.

Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate, dial

(866) 393-4306 (domestic) or (734) 385-2616 (international); access code 8789908. 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 February 15, 2018 until 11:59 p.m. ET on March 15, 2018. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 8789908. The archived webcast will be available in the Investor Relations section of the Acorda website.

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 2018 guidance for R&D and SG&A expenses 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 compensation 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 related to the Fampyra monetization, non-cash interest charges related to our asset based loan which was terminated in 2017 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 periods, (iv) acquisition related expenses and related foreign currency losses and gains that pertain to a non-recurring event, (v) corporate restructuring expenses that pertain to a non-recurring event, (vi) asset impairments which are non-cash charges that relate to program terminations that are not routine to the operation of the business, and (vii) gain on sale of assets that pertains 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 2018 guidance for R&D and SG&A expenses 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.