Murdo Gordon
Analyst · Matthew Harrison with Morgan Stanley. Matthew, your line is open
Thanks, Dave, and good afternoon, everyone. We started the year with strong volume-driven growth of 15% on a global basis with 10% in the U.S. and 32% ex-U.S. Growth was generated broadly across our portfolio of newer products more than offsetting declines in our mature brands. Given the unprecedented nature of the COVID-19 pandemic, I want to start by sharing our views on how disruptions in the global health care system may impact our business, and then I'll walk through what we're seeing at the product level and what actions we are taking. Like others in our sector, we're seeing varying degrees of impact from COVID-19 across our portfolio as physician-patient interactions are interrupted. These reduced interactions have led to some delays in diagnosis and treatment, which in turn reduces new patient starts. Data from IQVIA suggests that patient office visits have declined by over 50%, although some of this is being offset by telemedicine and telehealth services. Data also show that some patients refilled prescriptions early and that there was a modest benefit of approximately $100 million from inventory in the quarter. Finally, increased utilization of patient affordability programs and changes in segment mix due to increased U.S. unemployment could negatively impact U.S. net prices. Treatments like Prolia that require in office administration by a health care provider have been negatively impacted. On the other hand, the product like Otezla may benefit given that it provides a convenient oral option for patients compared with injectable or IV biologics, some of which require monitoring. Despite this disruption, our teams are responding to customer needs via remote interactions. We're identifying innovative solutions to help patients and we're supplying products reliably and consistently. Now let me review some product details beginning with Prolia on Slide 12. Prolia grew 10% year-over-year from higher volume. Strong demand growth in January and February was consistent with prior years. In March, we began to see a negative impact on Prolia in office injections and have since observed a substantial step down in utilization versus prior years. In more recent weeks, we're beginning to see signs of stabilization and we'll be able to provide more clarity on this when we report our Q2 results in July. The importance of treating osteoporosis in patients who are at high-risk of fractures is critical. Our teams are working to address continuity of care issues and exploring novel solutions such as alternate sites of care, mobile nurse-administered injections, prescription fills at specialty and retail pharmacies. We're also working with policymakers and advocacy organizations to address treatment challenges in this environment. Moving to Evenity, which launched in Japan and the U.S. in the first half of 2019. Evenity posted $100 million in sales during the first quarter, driven by continued uptick. In Japan, which represents roughly two-thirds of Evenity sales, we've attained shares similar to those established anabolic therapies. In the U.S., we saw an acceleration in demand trends with improvements in persistence in Q1 as clinics gained more experience. As patients complete their one year cycle of therapy with Evenity, we will work with healthcare providers to help transition these patients to Prolia. Evenity and Prolia are a complementary set of options to address the 9 million fractures that occur worldwide in postmenopausal osteoporosis patients and our teams are focused on ensuring these patients are not compromised during this pandemic. Moving to Repatha. We're off to a strong start in 2020. Our efforts over the past 18 months to improve access and affordability have yielded strong results as Q1 sales grew by 62% year-over-year, driven by 98% volume growth versus the same period last year. New-to-brand prescriptions in the U.S. steadily improved in Q1, growing 51% year-over-year and we held 80% market share exiting the quarter. As we appreciate in our last earnings call, Part D contracting to improve access and affordability resulted in a step down in Repatha's net selling price in Q1. We expect net selling price to be relatively stable for the remainder of the year. On to Aimovig on Slide 15. On a year-over-year basis, net sales grew 20% with underlying volume growth of 46%. Aimovig remains the market leader with 48% total prescription share. To date, almost 330,000 patients have been prescribed Aimovig by more than 33,000 prescribers. With the recent addition to CVS National Preferred Formulary, we now have access to 93% of covered lives, which led to a 19% growth quarter-over-quarter in new-to-brand prescriptions. Net price was sequentially lower due to expanded access with CVS and higher co-pay utilization that occurs each year in the first quarter. These factors were partially offset by the proportion of paid prescriptions increasing to almost 90%, up from 81% in Q4 of 2019. Next to our inflammation portfolio starting with Otezla. Integration has been seamless evidenced by 23% year-over-year growth driven by volume. These results coupled with planned label expansion give us confidence in our ability to realize the full global potential of Otezla, as an affordable option with a very well-defined efficacy and safety profile. In the current COVID environment Otezla provides a convenient oral option for patients. It's conducive to telemedicine and does not require lab monitoring. Moving to Enbrel. Sales were $1.2 billion in Q1 and included a $70 million year-over-year benefit from favorable changes in accounting estimates related to sales deductions. Consistent with prior trends, prescription volumes declined 5% year-over-year. We continue to expect a limited benefit from net selling price in 2020 versus 2019. In this environment, we're supporting Enbrel's strong continuing base of patients in maintaining their course of therapy through disruptions and out-of-pocket cost barriers. As you know, Enbrel has been on the market for over 20 years and does not require routine lab monitoring. Now to slide 18. Another contributor to our inflammation franchise is Amgevita, which for three consecutive quarters as the number one adalimumab Biosimilar in Europe recording $86 million of sales in Q1. Switching to our hematology and oncology business, our innovative portfolio of six brands collectively totaled $1.3 billion in the quarter growing by 11% year-over-year. Certain products like XGEVA may be impacted in the current environment due to disruptions in physician-patient interactions. Although others including Neulasta Onpro and our oncology biosimilars MVASI and KANJINTI provide greater value. Let me highlight some of our larger products. KYPROLIS grew 14% year-over-year led by a 21% increase in U.S. sales, which was driven by expanded use in second and third-line multiple myeloma. Neulasta declined 40% year-over-year recall that Q1 of 2019 benefited from a $98 million BARDA order, which did not repeat this quarter. OnPro continues to be the preferred choice and has held quarter-over-quarter share at 54% despite facing an additional competitor. The revised NCCN guidelines recommend increased use of G-CSFs to minimize the risk of febrile neutropenia in cancer patients. Onpro provides a unique value proposition, particularly, now as patients can receive their G-CSF treatment without having to return to their site of care. Our two oncology biosimilars MVASI and KANJINTI generated $234 million in sales globally in the first quarter. In the U.S., they sold $108 million and $96 million respectively with market shares exiting Q1 at or above 27%. We continue to see encouraging adoption rates in clinics with hospital adoption accelerating. These biosimilars are increasingly valuable given the cost savings that they provide. Switching to nephrology, starting on slide 24. Given the serious nature of end-stage renal disease patients require dialysis treatments three days per week. Therefore, we're not seeing a meaningful impact on the use of Amgen medications in these patients that would attribute to COVID-19. In Q1 EPOGEN sales declined 29% primarily due to lower net selling price from our contractual commitment with DaVita and approximately $20 million of unfavorable changes in accounting estimates. Sensipar sales declined 42% year-over-year due to the impact of generic competition. As a reminder, supplemental patent protection certificates for cinacalcet have now expired in major EU markets, which could result in a significant decline in ex-U.S. sales in 2020. Parsabiv grew by 39% year-over-year in the first quarter. Independent and midsize dialysis providers already utilize Parsabiv for a majority of their calcimimetic patients. While FMC and DaVita continue to increase adoption. In summary, I'm truly inspired by the entrepreneurial spirit of our employees who are helping patients and health care providers in this unprecedented time. And with that I'd like to turn over to Peter.