We closed 2016 with the submission of our first NDA for ITCA 650 in T2D, earning yet another $100M milestone payment from our 2015 Royalty financing.
Between debt, our Series EE equity financing, and the royalty milestone payment we secured nearly $600M in capital in 2016. We have a 3rd and final close of our Series EE round planned in 1Q 2017.
We just signed a major strategic partnership with the Bill and Melinda Gates Foundation aiming our Medici technology at preventing HIV. Novel Medici treatments and preventions: Our vision is in motion!
In 2017 we are focused on scaling the business and driving robust execution as we work with global health authorities and fully prepare to bring our first medicine to patients with type 2 diabetes.
A novel alternative to pills and injections: It’s what’s been missing for far too long in major chronic diseases! Our Medici Drug Delivery System and the multiple medicines we aim to bring to market over time are disruptively innovative, and at the same time highly practical solutions for chronic disease management, as well as potential prevention therapeutics. Our proprietary technology not only allows us to optimize the benefit/risk profile of chronic medicines, the ultimate elegance is that our once- or twice-yearly medicines are also designed in a way that they take patient forgetfulness and other poor medicine adherence behaviors off the table. No matter what chronic disease we go after, our ultimate goal is to significantly improve therapeutic and economic outcomes with therapies that are well tolerated, have proven greater effectiveness than the standard of care, and have proven greater adherence and control over time – particularly in real world settings where patients are left on their own. In just about every major chronic disease, the majority of patients are poorly controlled over time because their medicine is not highly effective in real world circumstances. Most patients are not taking their medicine as prescribed and the rate of non-adherence is alarmingly high! Many patients don’t even fill their first prescription, let alone refills! The truth is the majority of patients stop taking their pills and injections as prescribed after only 6-12 months.
This “elephant in the room” holds true for almost every major chronic disease around the world. And it makes complete sense when you think about it, because it fundamentally deals with human psychology and behavior – and the extreme difficulty encountered when trying to change medical compliance and adherence behaviors. A minority of patients are highly compliant with prescribing instructions when they get a serious disease, however, the majority of patients are not. Yet our industry introduces new pill after new pill, and new injection after new injection – as if the next one were somehow going to miraculously turn around poor control and poor adherence where dozens of pills and injections have failed to do so previously. Type 2 diabetes treatment is a perfect illustration of this failure given that glucose control and therapeutic adherence trends haven’t improved at all over the last 10 years despite the introduction of more than 40 new pills and injections for the disease. New pills and injections have great intrinsic merits for some patients, but we cannot afford to go on ignoring the fact that the majority of patients just aren’t going to take them frequently enough to derive the intended benefits and outcomes over time!
Little wonder, then, that Intarcia is increasingly capturing the attention of leaders within academic medicine, world-class investors, social impact stakeholders, industry collaborators, journalists, patient advocates, payers, and policy-makers. Our Medici-based therapeutics is an idea whose time has come … medicines must be made available that work effectively and reliably in the ‘real-world’ circumstances in which patients live. It’s also time to stop blaming patients for being “weak-willed” and “irresponsible” when it is really current delivery systems that are failing patients. As an industry it is up to us to bring highly effective medicines in new delivery systems to patients with the confidence that they have been designed with their needs in mind, and that they hold the potential to transform control and adherence over time for better outcomes.
Intarcia’s journey has been non-traditional, and in many ways, there is no analogue for our technology, for what we’ve done to date, and for what we aim to do next. We look forward to the opportunity to bring our first investigational therapy to patients and to see what a huge stride forward for patients that it could represent. We are getting very close to potential commercialization within the next year. We hope to extend the ‘theoretical’ leap forward only witnessed in clinical trials, to a practical achievement in clinical medicine and real-world outcomes where the unmet needs are the greatest for millions and millions of people. So, in the New Year we continue our rapid pace of preparation for the potential approval and launch of ITCA 650 in type 2 diabetes. We are also advancing our longer-term therapeutic pipeline, where we aim to advance therapies that may set a whole new standard, yet again, for further improvements in glycemic control, entirely new standards for weight reduction, and possibly optimal cardio-protective benefits as well. We also plan to advance our program in the auto-immune therapeutic area, and our latest and very exciting pipeline project with the Gates Foundation aiming to prevent HIV.
Our partnership with the Gates Foundation is particularly exciting to me because it is the first, but certainly not the last, project aiming to demonstrate and realize the full potential of our Medici technology platform in the prevention of a major chronic and life threatening disease. We will also co-invest in enhancements to the Medici platform itself as we pursue this new quest for a more effective, more reliable, and more affordable HIV prophylactic therapy. The partnership itself is exhilarating and inspiring on many levels. We look forward to working with an organization as world-class and nobly purposed as the Bill and Melinda Gates Foundation. It is an instance where “Living Our Values” and “Our Core Purpose” is fully aligned, and we are very honored to be working in partnership.
Moving into 2017, our Company continues to cherish our privately held status, as we see it as a very real opportunity and advantage at this stage of our growth and preparation for our first launch. It allows us to focus completely on execution and fully commit to the critical decisions and actions we must make to drive our key strategies and high impact initiatives for growth. This is much more than a matter of style. We believe it is a pathway to greater near and long-term success at a critical point in our strategic evolution toward a fully integrated and multi-product company. In fact, by remaining private and “going it alone” through the first year of launch and revenue generation, we can accrue powerful benefits. This includes our level of customer focus and prioritization during launch, our ability to stay gyroscopically on course and flexible, and our ability to maintain urgency in making timely decisions and taking reasonable and well-calculated risks. It also helps us sustain our lack of bureaucracy and avoid external distractions that don’t add value. There are important strategic considerations during this time as well, and these are all powerful advantages that facilitate greater execution and potential success in the marketplace. Last but not least, as promised before, in parallel we are advancing our Medici Drug Delivery System and our novel pipeline of medicines so that when we do go public, we hold the promise of multiple game-changing therapeutics and preventative medicines in chronic diseases. Ultimately, our goal is to build one of the most important companies in the chronic disease space, and we are well on our way.
Onward into 2017 … a year that promises to be our most challenging and exciting yet! We are on the doorstep of touching patients’ lives and improving outcomes, and that has always been our central goal. I again thank our incredible Intarcia team for their passion and tenacity of purpose, and all our key stakeholders for their steadfast commitment and support.
All the best in 2017!! Stay tuned!!
Chairman, President and CEO
Intarcia Therapeutics, Inc.