CFO Q&A

NuPathe is specialty pharmaceutical company with a late stage product near FDA approval. Delivering this initial product candidate, the world’s first migraine patch, exemplifies our key strategy of marrying patient needs to overcome the pervasive migraine-associated gastrointestinal issues with commercial opportunity. Once approved, our migraine patch has significant market potential to address the needs of a large underserved population of people suffering from debilitating migraine including migraine-related nausea. In our robust clinical program, the migraine patch offers migraine sufferers relief from headache pain and migraine-related nausea with low incidence of adverse events known as triptan sensations. In addition, this technology offers a significant franchise opportunity well beyond migraine in the global transdermal market. Looking further into our product pipeline, we are progressing our long-term biodegradable implant portfolio, addressing populations of underserved patients battling Parkinson’s disease, bipolar disorder, and schizophrenia migraine sufferers.

Our #1 objective is to obtain FDA approval for and subsequently launch our first product, the migraine patch. We expect to resubmit our NDA in the first half of 2012. Beyond that important milestone, we are also aiming to advance our additional product candidates—NP201 for the continuous symptomatic treatment of Parkinson's disease, and NP202, which is in preclinical development for the long-term treatment of schizophrenia and bipolar disorder. We are seeking a partner for NP201, and expect to file an Initial New Drug Application (IND) with the FDA for NP202 in 2013.

At NuPathe, we believe that if we serve patients, sales will follow. This strategy allows us to focus on developing innovative treatments for our core patient populations to drive our commercialization strategy. Our capital strategy aims to achieve a balance of strategic growth and appropriate cost controls. To progress a drug from concept to clinic to market, being prudent is as important today as being groundbreaking. NuPathe has always taken a prudent approach to adding incremental costs to the business.

We all live in this complex global economy, and emerging growth companies are certainly not immune. Clearly the challenges in accessing capital could negatively impact the pipeline of innovative therapies from both small and large pharmaceutical companies.

We believe these challenges offer an opportunity to simplify our approach to deliver tailored therapeutic solutions to underserved patient populations. As an emerging company, this environment demands smart innovation – developing treatments that not only improve on existing drugs or technologies but do so in a manner that truly meets a patient need. With this focused approach, we believe we can deliver the commercial results needed to grow our company and reward our shareholders.

Our biggest opportunity in the near term is our ability to continue to educate physicians on the debilitating effects of migraine-related nausea. Migraine, characterized most frequently by migraine headache pain and migraine-related nausea, is a debilitating neurologic disease affecting 31 million people in the U.S. We believe millions of these patients are not adequately served and that we have developed an ideal solution to help them find relief and get back to living their lives. Likewise, our earlier-stage product pipeline targets large and underserved patient populations.

I look to Cal Ripken, Jr., and his extraordinary baseball career spanning 21 years and 3,000 games, including 2,632 games in a row. He exemplified the perseverance and tenacity that I strive for: he showed up every single day, never missing a single game, and had an unquestionable work ethic. Cal was also adaptable and flexible. When he was called upon to change positions, he did; when he needed to change his swing, he did. Specialty pharma, like baseball, requires adaptation, flexibility, and tenacity to drive long-term success.