Significant progress has been made since our landmark $210 million financing last November. Consistent with our highest priority, we began enrolling patients early this year in FREEDOM, our global Phase 3 clinical trial program. More than 4,000 patients will participate in four studies, and enrollment is progressing. We will have our first data from the phase 3 program reported early in the New Year (2014), so stay tuned for our presentation set for JP Morgan in January. In parallel with our patient recruiting, we also made significant strides with a very different recruiting priority: hiring top talent to strategically advance the breadth and depth of our skills at every level. This has included two new members added this year to our Executive Team, and other key hires who have joined at various levels to help us build Intarcia and drive our operations with excellence. We also added an important new member to our Board of Directors this summer, Gino Santini, and as of early December we are delighted to have Nancy Thornberry join our Board. Nancy had a remarkable 34-year career at Merck Research Laboratories, where she co-led the team that discovered their blockbuster type 2 diabetes drug Januvia™. Every appointment we make is mission critical, and I’m extremely pleased that we’ve successfully attracted some of the best, brightest and diverse talent in the industry. Each of these appointments has moved the right talent into the right place so we can collectively take our ambitions and our capabilities to the next level.
Our Boston and Hayward Sites Take Giant Strides Forward
Both of our sites in Hayward and Boston have made huge strides this year. Our new Boston site – which serves as our new headquarters – is now in full swing. Its open-space design and innovative feel, along with a great view overlooking a cityscape on one side and Boston Harbor on the other, all come together to create a work environment that is a perfect reflection of our company’s bright future. I know it will be a great talent magnet right here in the very center of the "Innovation District" within Boston. Our great progress in Boston was mirrored with equally important progress in Hayward. At a very recent visit to our Hayward site, I took a tour to see firsthand the progress made possible by our investments – installing and qualifying all of our new, custom, state-of-the-art manufacturing equipment required for commercial scale-up. Seeing the two large spray dryers at work and then the fully automated and robotic assembly equipment simply blew me away. To see thousands of our mini-pumps being assembled with flawless perfection was quite exciting, to say the least. While there is always more to be done, it is a major accomplishment for us to already be at this stage of scale-up and commercial readiness with proprietary equipment like we’ve built. I have every confidence our Hayward site will continue to shine as a very special set of people, assets, and capabilities allow us to make and deliver once- or twice-yearly medicines that no other company can. As a result of all this progress, I truly feel we have reached the “tipping point” with our talent, our leadership team, our capabilities, our sites, and our culture – where it now can all coalesce into an ongoing competitive advantage. And the more each one of us commits to excellence in our own area of responsibility, the more value will be built for patients and all our stakeholders. We’ve come a long way. But it is up to each of us to grab this opportunity and drive it further for the betterment of patients and for the satisfaction of having made a difference in their lives. Each one of us has to commit, raise our game, and perform at our very highest level. I believe our culture is such that it now can help us keep that drive alive.
Continuing on our theme of "significant progress," there is another dimension of progress to report – progress that promises some exciting possibilities.
Innovation Driven by our People, our Insights, our Networks and our Partnerships
Paralleling our trials, talent acquisitions and business milestones, we have been exploring several innovative new ways of collaborating to increase growth opportunities during our clinical trials for ITCA 650, and if successful, also at commercialization. We will have more to say about these possible collaborations, pipeline opportunities, and financing activities in the coming months.
As noted, we’ve now officially become citizens and good neighbors of the Greater Boston Area, so I now hope our future employees will start to peer through our open-space glass doors and take a closer look at what is going on here. The mission we are pursuing, the diseases we are taking on, the innovations we are delivering, and the people and work experience at Intarcia all speak for themselves. So I’ll let you draw your own conclusions. But as a result, I hope to get to meet some of you real soon.
A Quick Introduction to our Mission
We are here to make a big difference for patients, payors and providers in serious diseases. Not incremental differences – medicines that unleash transformational differences that noticeably change patients’ lives for the better, and dramatically improve health and economic outcomes for each key stakeholder in the healthcare system. By doing this – and the more we do it – we know we will make a fulfilling difference for ourselves and for our investors, too.
All of this is much easier said than done, and it isn’t risk free. But just imagine what the first and only once-per-year medicine could do to fundamentally change effectiveness, remove self-injections, ensure near 100% compliance rates, and reshape outcomes in a serious disease like diabetes. We can only achieve these goals if, on balance, we exceed our competitors’ level of talent, passion, tenacity, and urgency of purpose. Here is where and why we unleash our talent ... by resourcing our people’s best thinking and work effort. We also carefully maintain our culture so that working hard and effectively here are worth the effort. Why? Because it’s exhilarating and fun to push yourself so you reliably achieve your goals along with your colleagues. Imagine being very impressed by your colleagues and enjoying working with them because you know that together you will make a difference on a global scale for millions of patients. That really matters – to do this in one of the biggest, deadliest and costliest diseases on the planet is a very rare opportunity. What is more invigorating than winning, not just games and battles, but wars against major diseases on behalf of patients who deserve a better life?
I extend my heartfelt and continued appreciation to our team of employees, business partners, and investors – people who see our vision, share our purpose, and follow it all through to the results. While we are striving to get better every day, what has unfolded so far in 2013 is remarkable. I am very confident about our current position and our road ahead.
Chairman, President and CEO