Shire plc (SHPGY) Q3 2011 Earnings Call October 28, 2011 9:00 am ET Executives Michael Cola - President of Specialty Pharmaceuticals, Member of Senior Staff Committee and Member of Management Committee Graham Hetherington - Chief Financial Officer, Principal Accounting Officer and Director Sylvie Gregoire - President of Human Genetic Therapies Business and Member of Management Committee Angus Russell - Chief Executive Officer and Executive Director Jeff Jonas - Senior Vice President of Research & Development for Pharmaceuticals Business Eric Rojas - Director of Investor Relations - North America Analysts Ken Cacciatore - Cowen and Company, LLC, Research Division Thomas J. Russo - Robert W. Baird & Co. Incorporated, Research Division Gary Nachman - Susquehanna Financial Group, LLLP, Research Division David M. Steinberg - Deutsche Bank AG, Research Division Keyur Parekh - Goldman Sachs Group Inc., Research Division Luisa Hector - Crédit Suisse AG, Research Division Peter Verdult - Morgan Stanley, Research Division Graham Parry - BofA Merrill Lynch, Research Division Frank H. Pinkerton - SunTrust Robinson Humphrey, Inc., Research Division Guillaume van Renterghem - UBS Investment Bank, Research Division Presentation Operator
By now, you should have all received our press release and should be viewing our presentation via our website on shire.com. If for some reason you have not received the press release or are unable to access our website, please contact Souheil Salah in our U.K. Investor Relations department on +44-1256-894-160 and he will be happy to assist you.Our speakers today are Angus Russell, Graham Hetherington and Jeff Jonas. Mike Cola, Sylvie Gregoire and Kevin Rakin will be available for Q&A as well. Before we begin, I would refer you to Slide 2 of our presentation and remind you that any statements made during this call which are not historical statements will be forward-looking statements and as such will be subject to risks and uncertainties which as they materialize can materially affect our results. Today's agenda is on Slide 3. Angus will comment on Shire's Q3 performance and recent highlights. Graham will continue with a financial review and update Shire's full year outlook. Jeff Jonas will give an update on financial uses, and Angus will make closing remarks and open up the call for your questions. We request that you only ask 2 questions so that everyone gets a chance to participate in the call. Sarah Elton-Farr and I will be available after the call for any follow-up questions. I'll now hand the call over to Angus. Angus Russell Thanks, Eric, and good morning, good afternoon, everyone. If we just turn to Slide 5, and I'll start with the revenue performance, which once again this quarter was very strong. Total revenues were up 24%, the second quarter we delivered more than $1 billion in revenues. In this quarter, product sales performance within that was up a very strong 28% and also delivered over $1 billion. For me, this reflects a very balanced strong growing portfolio of products. Most importantly, the growth is mostly volume driven with very little price components in these overall results.
Turning to the next slide and looking similarly at the earnings line. Most importantly, on track, we believe now to deliver what we've seen as increasing earning expectations over the course of this year, and that will once again deliver significant growth for 2011. This quarter, you've seen a trend of reinvesting back into the business, and we'll be giving you some highlights later in this presentation about how we're investing in interesting late-stage pipeline developments.Turning now to some of the business highlights on the next slide and starting with our Specialty Pharma business. Firstly, VYVANSE, very strong again prescription volume performance this quarter. Prescription has increased 20% over the same quarter of last year, and that's double the 10% quarterly total market growth, which obviously reflects market share gains during the quarter and a strong back to school season. This quarter, we're also showing you results on our EU Phase III pediatric trial. This data is very consistent with previous results we've generated on efficacy and safety in our U.S. studies and is profiled to previous studies of that nature. It also, this study, includes interestingly a Concerta reference arm, and for me, this reflects the need to do studies against current standards of care, particularly in Europe but I believe in time, this will extend to most jurisdictions and healthcare around the world. And so for me, it's very groundbreaking for Shire to be doing this kind of study. That is to say, the new paradigm of treatment. And Jeff Jonas will be talking a little bit more about that later in this presentation. We're also progressing our non-ADHD indications of VYVANSE, and Jeff will also be previewing particularly the work in major depressive disorder in our now commencing Phase III study. Moving to INTUNIV, prescriptions increased 9% over Q2 this year and 59% over the same quarter of last year. Again, this reflects favorable increases in market share trends being driven by our new consumer marketing campaigns and the adjunctive therapy with stimulant launch that took place earlier this year. We're also enrolling our EU pivotal Phase III programs for INTUNIV.
Looking now at MEZAVANT or LIALDA. U.S. prescription market share again increased to 20.7%. As you remember, the FDA recently approved the new label indication for LIALDA to add a maintenance of remission claim, and that's clearly beginning to have an effect on driving continued market share gains.Now turning to our HGT segment, starting off with FIRAZYR. If you remember, just last month, we received approval here in the U.S. for the the self-administration for acute attacks of hereditary angioedema in adults. We've commenced our launch and I'm pleased to say that the product seems to be very well received by patients, physicians and payers. With regard to REPLAGAL in the Fabry market, our x U.S. market share continues to climb and has now exceeded 80%. You can see here 81% at this current moment in time, driven both by switch from existing treatments and also new patient growth. We're continuing to meet the very high demand, and we're monitoring closely to ensure that we can provide supply continuity to the patients moving onto our treatment. You'll have seen also in the press release that we've announced that we've commenced a rolling BLA submission in the U.S. following discussions with FDA, and I'm sure you'll have further questions for Sylvie in regard to the current status of that BLA program. Overall then, we've seen 40% growth in revenues in REPLAGAL in the quarter versus the same period last year. VPRIV, not a dissimilar story to REPLAGAL in that we're seeing continued sharp increase in demand, really created by ongoing shortages with Cerezyme. So growth in the quarter, again a very strong 31% compared to the same period last year. Read the rest of this transcript for free on seekingalpha.com