Howard Robin
Analyst · JPMorgan. Your line is open
Thank you, Jennifer. Thanks to everyone, thanks to everyone for joining us today for our first quarter 2015 financial results call. Over the past seven years, we worked hard to build a late stage and diversified pipeline with significant revenue potential that positions us to move toward the goal of becoming a cash flow positive, sustainable company, not reliant on the markets for equity capital. With the recent launch of MOVANTIK and the anticipated approval of BAX 855 this goal is now in sight. We are proud of the pipeline we built at Nektar, which includes four phase 3 programs, one filed BLA and a recently approved and launched medicine. Our clinical late stage partnered programs combined with the revenue streams from MOVANTIK and BAX 855 could lead to peak royalty revenue of $750 million annually. As strategy, has always been to balance our development risk across multiple drug candidates in therapeutic area. We are currently taking a hard look at our new term development priorities and spend with the goal of advancing our pipeline while at the same time avoiding dilutive financing. As I just said, with the recent launch of MOVANTIK and the upcoming potential approval of BAX 855, we're beginning to see important new medicines emerge from nectar's pipeline. MOVANTIK is a first in class new targeted medicine for patients with OIC and it has the potential to be a multibillion dollar market opportunity. BAX 855 as the next generation ADVATE also has the potential to be a multibillion dollar market opportunity. With respect to NKTR-102, we're working diligently to find regulatory path forward for NKTR-102 in the U.S and Europe based upon the BEACON data alone. NKTR-102 is a promising anti-cancer drug and to illustrate this Dr. Edith Perez of the Mayo Clinic will be presenting BEACON results in an oral abstract presentation on June 1st at the upcoming ASCO meeting. We expect to complete our regulatory discussions for Nektar-102 by the end of this year. Now I'd like to first focus on the recent success for launch of MOVANTIK and the near-term potential approval of BAX 855. Later in the call, Ivan will talk more about two of our clinical candidates NKTR-181, which could address a major problem in our society opioid abuse and NKTR-214, which has the potential to becoming an important medicine in the next generation of cancer immunotherapies. We're pleased that AstraZeneca has reported that the recent launch of MOVANTIK in the U.S. is progressing well. AstraZeneca has indicated that the drug is being positively received by physicians, which is resulting in increased time with sales reps. In Q1 AstraZeneca signed a marketing collaboration with Daiichi Sankyo in the U.S. under which Daiichi will provide primary care sales reps starting in May which will add to the AstraZeneca sales reps currently promoting MOVANTIK. We're pleased with the new Daiichi partnership for several reasons. First, Daiichi Sankyo clearly believes in the potential market for MOVANTIK. And this was demonstrated by the $200 million upfront payment made by Daiichi for the rights to market the drug and receive commission related sales payments. Second, the collaboration gives MOVANTIK a broader and larger sales force than originally planned and a further contribution by Daiichi to the direct-to-consumer advertising program for the drug. Third, AstraZeneca will continue to book all of the revenue from MOVANTIK demonstrating their commitment to the drug and their desire to retain ownership of the long term success of MOVANTIK in its largest market. As you know MOVANTIK is the first and only Peripherally-Acting Mu-Opioid Receptor Antagonists or PAMORA to be approved to treat OIC. As I just stated, although it’s early in the launch AstraZeneca is reporting that it's progressing nicely. We're particularly pleased that AstraZeneca was able to gain preferred formulary access. We believe there is a significant market potential for MOVANTIK in the United States and Europe. In the U.S. there are approximately 38 million patients who take daily opioids to manage their chronic pain. These chronic pain patients have an approximate therapy duration of about 5 months and up to 80% of these patients experience OIC. With this high number of patients and cost of $260 per month, it is not difficult to imagine that even with a very small percentage of these patients of MOVANTIK sales can easily reach over a billion dollars annually. In Europe, there are an additional 12 million patients they can hope you expect chronic payment. Is the first oral PAMORA, MOVANTIK provides an important new targeted mechanism to address the underlying cause of OIC. We believe MOVANTIK is unlikely to face competition from other oral PAMORA therapies for at least two years. Our partner AstraZeneca estimates the sales potential of MOVANTIK to be more than $1 billion annually. In Q1 for the U.S. launch and first commercial sale in the U.S., we received the $100 million milestone payments from AstraZeneca. European launch and a major market triggers another $40 million milestone payments to Nektar. The drug is already available in the Nordic markets including Sweden, Norway, England and Denmark. The first plan launches a major European markets are Germany and the UK, which we expected to occur in the second half of this year. Nektar will receive accelerating royalties on net sales, which in the U.S. start at 20% and in Europe in the rest of the world start an 18%. In addition to these royalties, we also have the potential to receive up to $375 million and sales milestones based on achieving certain annual sales targets. Following the recent accomplishments for the launch MOVANTIK and significant level of commitment from AstraZeneca and the AG to the success of the drug we are positive about the prospects for MOVANTIK as an important new medicine per patience OIC and about its potential ability to brought by Nektar with substantial revenue. I’ve just told you about MOVANTIK, but we achieve positive Phase 3 clinical results leading to a successful approval and launch. Now let’s talk about the next important medicine that we expect to contribute to our past the cash flow positive Baxter BAX 855. These upon highly successful Phase 3 clinical results for BAX 855, we anticipate approval and launch of BAX 855 by the end of this year. Baxter recently announced that they submitted a new drug application to Japan Ministry of Health for the approval of BAX 855. In addition in the first quarter Baxter completed enrollment in the pediatric trial of BAX 855, this study will support post approval label expansion in the U.S. or previously treated pediatric patients and European regulatory submission in 2016. BAX 855 is also being evaluated and PK specific dosing study to support both U.S. and European label expansions and regulatory approvals. As you know BAX 855 is the next generation ADVATE, a medicine which has global sales of over $2.5 billion. As an important continuation of the ADVATE brand, we are excited about the potential approval and launch of BAX 855 later this year. Nektar’s entitled to receive mid-single digit royalties on sales up to 1.2 billion and royalties in the low teens on sales greater than $1.2 billion, as well as an additional $73 million in development and sales milestones. Again, the economic potential of MOVANTIK and BAX 855 alone to contribute substantial revenues to Nektar. Two additional late-stage programs Amikacin Inhale and Cipro Inhale are also pause to become important new potential medicines. These programs are schedule to complete Phase 3 in 2016 and they two represent significant potential revenue streams for Nektar. Amikacin Inhale and Cipro DPI are both noble drug device anti-infective products that have been granted qualified infectious disease product or QIDP designation by the FDA. Both products are design to deliver the anti-bacterial therapy deep and alone in order to achieve both higher concentrations at the size of infection and also lower systemic exposure for significantly reducing the toxicities associated with these agents when administered systemically. Amikacin Inhale targets Gram-negative pneumonia in ventilated patients. With SPA in place, the primary end point of the Phase 3 program is clinical response at a test of cure visit following a 10-day treatment period. Bayer expects to complete these trials in the first part of 2016. The global market for Amikacin Inhale is estimated to be approximately $700 million, which could translate into highly significant revenues for Nektar. We will receive a flat 30% royalty on U.S. sales in an average of 22% on ex-U.S. sales. This level of royalty is the equivalent of owning half of the drug. Cipro DPI is targeting non-cystic fibrosis bronchiectasis or NCFB, the Phase 3 RESPIRE program features two 48-week multinational randomized placebo control studies with data expected in the second half of 2016. The market for Cipro DPI is estimated to be about $750 million and Nektar will receive an average 10% royalty on net sales. With that I’d like to turn the call over to Ivan to provide a clinical update.