President and CEO
Dear Members of the Acorda Community:
In 2014, we made significant strides in our mission to develop therapies that restore function and improve the lives of people with neurological disorders. Our progress was enabled by our grounding in scientific, medical and business excellence, and our focus on three core value drivers: AMPYRA® commercial performance; clinical pipeline; and business development.
Highlights in 2014 included:
- AMPYRA net revenue increased 21% in 2014 to $366 million. Due to the efforts and expertise of our commercial and medical education teams, AMPYRA is increasingly considered a standard of care among neurologists and the multiple sclerosis (MS) community for improving walking in MS. More than 100,000 people with MS in the U.S. have tried this important therapy since its launch in 2010, and we have been gratified to hear frequently from people who have benefited from AMPYRA about how much this has meant to them and their families. We are projecting continued growth of AMPYRA in 2015, with anticipated net sales between $405-$420 million.
- We acquired Civitas Therapeutics, adding global rights for two promising compounds to our pipeline, as well as the ARCUS technology platform, which has potential applications in multiple disease states. We also acquired a commercial-scale manufacturing facility for ARCUS-based products (click here for more information on the Civitas acquisition).
- We advanced two therapies into Phase 3 clinical trials: dalfampridine for chronic post-stroke walking deficits (PSWD) and CVT-301 for OFF episodes in Parkinson’s disease. Both of these compounds would address large patient populations with significant unmet medical needs.
- We completed our first Phase 1 study of rHIgM22 for remyelination in MS. The safety and tolerability findings support continued development of this therapy, which has a novel mechanism. We expect to initiate a second Phase 1 trial in the second quarter of 2015. Remyelination is widely considered to be one of the next frontiers in the treatment of MS. We are excited to be advancing this therapy in clinical trials.
- We continued to enroll the second Phase 1 study of cimaglermin alfa (also known as GGF2) in heart failure, and expect it to be completed in the second half of 2015. Cimaglermin represents a novel approach to improving heart function; our first Phase 1 trial showed additive improvements in cardiac ejection fraction over optimized therapy in people with Class 2 and 3 heart failure.
- We ended 2014 in a strong financial position, with over $300 million in cash and projecting a cash flow positive year in 2015.
We also experienced two disappointments in 2014: a proposed once-daily (QD) formulation of dalfampridine proved inadequate for inclusion in our post-stroke Phase 3 program, and we received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding our New Drug Application (NDA) for approval of PLUMIAZ to treat seizure clusters. However, the mark of success is not the absence of disappointments, but in how one responds to them.
We responded effectively to these challenges, initiating our Phase 3 post-stroke study with our existing twice-daily formulation of dalfampridine and also launching work on a new QD formulation with several independent collaborators. We have also engaged with FDA regarding PLUMIAZ and expect to provide a detailed update in the second quarter of 2015.
As anticipated, a number of parties have filed challenges to our AMPYRA patents. Our legal team is prepared for these challenges. We have five Orange Book listed patents on AMPYRA that extend through 2027, and will vigorously defend our intellectual property.
Looking ahead, we are focused on execution in the areas that are critical to growing our business in the coming years:
- Continue to build value in the AMPYRA brand in MS.
- Execute successfully on our high-value pipeline programs.
- Identify additional business development opportunities that will build on Acorda’s leading capabilities in neurology development and specialty pharmaceutical commercialization.
I want to take this opportunity to recognize Acorda’s associates for their dedication and the urgency they bring to developing cutting edge therapies. I’m especially pleased that our newest colleagues from Civitas share this commitment; the integration of our two companies has resulted in a stronger Acorda with a substantially enhanced product pipeline and capabilities.
On behalf of our management team and Board of Directors, thank you to our shareholders for your continued support. We are excited about our opportunities to build value in 2015 and beyond, and I look forward to updating you on our progress.
President and CEO