acorda therapeutics inc (ACOR) Key Developments
Acorda Therapeutics, Inc. Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Revises Sales Guidance for the Year 2015; Provides Cash Flow Guidance for the Year 2015
Jul 30 15
Acorda Therapeutics, Inc. announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter the company reported that total revenues were $113,707,000 against $97,129,000 reported last year. Operating income was $5,692,000 against $10,979,000 a year ago period. Income before income taxes was $2,127,000 against $10,718,000 reported last year. Net income was $997,000 or $0.02 per diluted share against net income of $4,685,000 or $0.11 per diluted share reported a year ago. Non-GAAP net income was $13,483,000 or $0.31 per diluted share against $17,737,000 or $0.42 per diluted share reported last year.
For the six months, the company reported total revenues of $213,559,000 compared to $177,648,000 reported in the same period a year ago. Operating income was $4,433,000 against $14,396,000 reported last year. Loss before income taxes was $2,997,000 against income before income taxes of $14,215,000 reported a year ago. Net loss was $2,088,000 or $0.05 per diluted share against net income of $5,390,000 or $0.13 per diluted share reported a year ago. Non-GAAP net income was $19,945,000 or $0.46 per diluted share against $26,531,000 or $0.63 per diluted share reported last year.
The company narrowed 2015 AMPYRA net sales guidance from $405 million -$420 million to $410 million -$420 million. The Company revised 2015 R&D guidance from $150-$160 million to $140-$150 million. This guidance excludes share-based compensation.
The company expects to be cash flow positive in 2015.
Acorda Therapeutics, Inc., Q2 2015 Earnings Call, Jul 30, 2015
Jul 23 15
Acorda Therapeutics, Inc., Q2 2015 Earnings Call, Jul 30, 2015
Acorda Therapeutics, Inc. Presents Data from a Phase 2b Clinical Trial of CVT-301
Jun 16 15
Acorda Therapeutics, Inc. presented data from a Phase 2b clinical trial of CVT-301, an inhaled levodopa (L-dopa) under development for the episodic treatment of OFF episodes associated with Parkinson's disease (PD). OFF episodes are characterized by a re-emergence of PD motor symptoms, such as impaired ability to move, muscle stiffness and tremor. The trial showed that patients experiencing an OFF episode, treated with CVT-301, showed significantly greater improvements in motor function than patients treated with inhaled placebo; the difference in improvement was already apparent 10 minutes after dosing and was durable for at least an hour, the longest time point at which patients were measured. The Phase 2b trial was a randomized, double blind, placebo-controlled, multicenter study in 86 people with PD for the treatment of OFF episodes. Participants were randomized to self-administer CVT-301 or placebo as an adjunct to oral PD medications. Participants received 35mg of CVT-301 or placebo delivered to the lung in weeks 1 and 2, and 50mg of drug or placebo delivered to the lung in weeks 3 and 4. In-office assessments of the Unified Parkinson's Disease Rating Scale Part 3 (UPDRS III) were performed at weeks 1, 2 and 4. The primary endpoint was defined as the mean change from baseline in UPDRS III score (10-60 minutes post dose) after 4 weeks of treatment. UPDRS III is an established scale to monitor PD motor impairment, and is considered a standard in the field. In this study, participants receiving CVT-301 showed a statistically significant and clinically important reduction in average UPDRS III motor score compared to placebo and across all measured time points beginning at 10 and up to 60 minutes post administration. Both doses of CVT-301 were well tolerated, with no increase relative to placebo in troublesome or non troublesome dyskinesias during ON periods. There were no serious adverse events reported in the drug group, and the incidence of drug-related adverse events was similar between treatment groups. The most common adverse events were dizziness, headache and cough; there were no adverse events on cardiovascular or lung function. PD patients were able to self-administer treatment while in an OFF state.
Acorda Therapeutics Eyes Acquisitions
Jun 2 15
Acorda Therapeutics, Inc. (NasdaqGS:ACOR) is looking for acquisitions. President Ron Cohen said the company wants to continue to acquire assets that leverage the core competencies of Acorda, those being in neurology development and also in a lead specialty neurology commercial organization that's capable of delivering additional therapies to the market.
Acorda Therapeutics, Inc. Provides an Update on the Status of its PLUMIAZTM (Diazepam) Nasal Spray Program
May 27 15
On May 27, 2015, Acorda Therapeutics, Inc. provided an update on the status of its PLUMIAZTM (diazepam) Nasal Spray program. The Company has completed discussions with the U.S. Food and Drug Administration (FDA), and is advancing the development of PLUMIAZ. Based on interactions with the FDA, the Company plans to conduct three clinical trials prior to resubmitting the New Drug Application (NDA) for PLUMIAZ. The first trial, a long-term open-label study assessing safety and tolerability of PLUMIAZ over 52 weeks, was initiated in December 2014. This study will enroll approximately 100 participants ages 12-65 and is expected to be completed in the second half of 2016. The Company will also conduct a pharmacokinetic dose proportionality study in healthy adults; this study is expected to be initiated in the third quarter of 2015 and completed in first half of 2016. The third study will assess the bioavailability, safety and tolerability of PLUMIAZ compared to diazepam rectal gel (Diastat®). This open-label, randomized, crossover study will enroll approximately 120 people with refractory epilepsy ages 12-65 who experience seizure clusters. This study is expected to be initiated in the second quarter of 2015 and completed in the fourth quarter of 2016. Pending the successful completion of these studies, the Company is planning to resubmit its NDA for PLUMIAZ in the first quarter of 2017. Based on FDA guidelines, the expected review period of the resubmitted NDA would be six months. If approved, the Company projects peak U.S. net sales revenue of more than $200 million. Previously, the Company estimated peak sales of more than $100 million; the increase is based on the unmet need in this market and expanding the clinical trial program to include adolescents. PLUMIAZ has orphan-drug designation. PLUMIAZ is being studied as a potential treatment for the management of selected, refractory patients with epilepsy currently on stable regimens of antiepileptic drugs (AEDs) who experience bouts of increased seizure activity. These bouts of increased seizure activity are also known as seizure clusters or acute repetitive seizures (ARS).