10/31/2023

speaker
Julianne
Moderator

I would now like to introduce Justin Clay's Vice President of Investor Relations. Mr. Clay, as you may now begin.

speaker
Justin Clay
Vice President of Investor Relations

Thank you, Julianne. Good morning, and welcome to our third quarter 2023 earnings call. Bob Bradway will lead the call and be followed by a broader review of our performance by Myrto Gordon, Bipram Karnani, who joined Amgem from Horizon Therapeutics following the October 6th 2023 Acquisition Close, Dave Reese, and Peter Griffith. Given the timing of the Horizon Therapeutics Acquisition Close, our third quarter results do not include any contribution from Horizon. Bikram will provide select information from Horizon's third quarter product sales for future context. You should have received a link to our slides that we have posted. Through the course of our discussion today, we will make some forward-looking statements and use non-GAAP financial measures to describe our performance. And just a reminder that actual results can vary materially. I would now like to turn the call over to Bob.

speaker
Bob Bradway
Chief Executive Officer

Okay. Thank you, Justin, and thank all of you for joining our call. It's an exciting time here at Amgen, and we're continuing to execute well this year, serving many more patients around the world with medicines such as Repatha, Avenity, and Tespire. advancing a number of promising first-in-class medicines rapidly through our pipeline and preparing for our next wave of biosimilar launches. However, as this is our first earnings call following the close of our acquisition of Horizon Therapeutics, I thought we might turn our attention there first. The Horizon acquisition, coupled with our purchase of Chemocentrics, which we acquired a little more than a year ago, gives Amgen a significant rare disease business, that fits squarely within our overall strategy and will be additive to the growth we expect from our base business. At the heart of our strategy, of course, is innovation. First, we're best-in-class medicines that make a big difference for patients suffering from serious diseases. The medicines in our rare disease portfolio, like Tavneos, Tepeza, Cristexa, and Uplizna, fit this description perfectly, and they'll benefit from Amgen's decades of experience in inflammatory diseases. These medicines are also early enough in their life cycles that we can positively impact their growth by leveraging Amgen's capabilities in process development, life cycle management, and manufacturing. Finally, we've spent the past decade or so building out our international footprint with Amgen medicines now available in about 100 countries. And today, our rare disease sales come almost exclusively from the U.S., so we'll be able to leverage our global presence to quickly bring these medicines to patients around the world. You'll hear more in a minute from Vikram Karnani, who joined us through the Horizon acquisition and is leading a newly created rare disease business that is now the fourth leg of Amgen's commercial stool alongside our inflammation, oncology, and general medicine businesses. Turning to our financial performance in the quarter, total revenues were up 4% and earnings per share were up 6% compared with a year ago. Volume increased 11% globally. which represents our fourth consecutive quarter of double-digit volume growth. And we achieved good balance across all of our geographic regions and therapeutic areas. Seven of our medicines generated record sales in the quarter, and I'll highlight one of these, Blinsido, which delivered 55% sales growth in the third quarter. We see continued upside potential for Blinsido as it is increasingly used in earlier lines of therapy, and as practice guidelines are updated to reflect the role this medicine can play in treating a broad range of patients with acute lymphoblastic leukemia. Turning to our pipeline, we had the opportunity to discuss six potential first-in-class oncology assets with you recently following ESMO. Three of these have earned breakthrough therapy designations from the FDA, terlatamab, blensido, and lumicras in combination with vectabix and colorectal cancer. We also continue to progress trials for bemerituzumab and gastric cancer, for xaluridamig and prostate cancer, and for AMG-193, our PRMT5 inhibitor, which has generated responses across six solid tumors. I'll just quickly note that AMG-193 was identified through our proprietary DNA-encoded library technology, which we added through the 2019 acquisition of New Evolution. and it demonstrates our leadership in the emerging field of multispecific drugs that can address pathways that have long been recognized but considered inaccessible to traditional drug discovery efforts. In other pipeline news, we've completed enrollment in our Phase II obesity study for Meridabart-Cafraglutide, which was formerly known as AMG-133. And finally, the FDA has accepted our BLA for a biosimilar to ILEA. Looking at our business, we feel we have good momentum across the board. We have everything we need with the portfolio, the pipeline, and the people to deliver attractive sales and earnings growth through the end of the decade and beyond. As always, I want to thank Amgen employees around the world, including some 2,000 new colleagues focused on rare diseases, for their commitment to strong execution on behalf of the patients we serve. With that, I'll now turn over to Murdo Gordon. Murdo?

Disclaimer

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