Amgen Inc. (AMGN) Q2 2023 Earnings Report, Transcript and Summary

My name is Julianne and I’ll be your conference facilitator today for Amgen’s Second Quarter 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. There will be a question-and-answer session at the conclusion of the last speakers prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking one question during the Q&A session. [Operator Instructions] I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood. You may now begin.

Thank you, Julianne. Good afternoon, everyone, and welcome to our call to discuss our results for the second quarter. We continued down the path of strong unit volume growth during the quarter that led to an improved outlook for the rest of the year. This also sets the stage for growth longer term augmented by some meaningful pipeline updates, particularly with an oncology development. Our Chairman and CEO, Bob Bradway, will lead the call with some prepared remarks, followed by a broader review of our performance by other members of our leadership team. You should have received a link to our slides that we have posted. Through the course of our discussion, we’ll 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. So with that, I would like to turn the call over to Bob. Bob?

Okay. Thank you for joining our call. It was an excellent quarter across the board for Amgen and one that demonstrates why we remain very confident about our ability to deliver attractive long-term growth in sales and earnings. We delivered $7 billion in quarterly revenue, up 6% from a year ago, along with record non-GAAP earnings per share of $5 a share, up 8% over the prior year. Volume growth globally was 11% in the quarter, and that reflects all three of our therapeutic areas and all three of our geographic regions contributing to performance. For example, volume in our general medicine business grew by 21% in the quarter, while volume in our Asia Pacific region, which we have previously identified as a key source of growth for us, was up 46%. At a time of product shortages in the industry, our world-class manufacturing capabilities have enabled us to meet growing demand for our products and continue our longstanding tradition of serving every patient every time. Nine of our medicines generated record sales in the quarter. This is consistent with my comments from our first quarter call in April when I said we see the potential for many of our currently marketed products to reach significantly more patients over time and to contribute substantially to our long-term growth. In April, I spoke about Repatha and the growing contribution it’s making in the fight against cardiovascular disease. Today I’ll highlight Prolia, which achieved $1 billion in quarterly sales for the first time, up 11%. Prolia is one of the first biologics to be widely prescribed by primary care physicians to treat a chronic disease, something we expect to see replicated over time in other categories like cardiovascular disease. For all of Prolia success though we know that osteoporosis remains an underdiagnosed and undertreated disease placing millions of elderly women at risk for life-changing fractures. With recently generated real world data, we’ve established that Prolia is superior to alendronate, the most frequently prescribed bisphosphonate treatment in the U.S. in reducing fractures, and not by a little, but by a lot. To give you one data point, in May we announced that in a real world study, Prolia reduced the risk of hip fracture by 36% compared to alendronate. That’s superior. Prolia and EVENITY, which achieved 47% sales growth in the quarter give us a powerful one two punch against osteoporosis, a disease that will only become more prevalent as the world grows older. You’ll hear more from Murdo shortly about our very strong commercial performance through the first half of 2023. We’re seeing strong momentum in our pipeline too, as you’ll hear in detail from Dave Reese, we’re sharing positive data today for our BiTE, tarlatamab in small cell lung cancer and for LUMAKRAS in combination with Vectibix in colorectal cancer. We are especially excited about the tarlatamab readout, not only because of what it may mean for patients whose prognosis is otherwise exceptionally poor, but also because it adds to our growing conviction that bispecific T-cell engagers are an effective way to treat solid tumors as well as liquid tumors as we have demonstrated with BLINCYTO. Elsewhere in our pipeline, we continue to advance registration enabling trials for several potential new first-in-class medicines including Olpasiran in heart disease, rocatinlimab in atopic dermatitis, and of course bemarituzumab in gastric cancer. We look forward to additional readouts from our pipeline in the second half of the year. Turning to our planned acquisition of Horizon Therapeutics, we remain very enthusiastic about what our companies can achieve together for patients suffering from rare serious diseases. Horizon has certainly accomplished a great deal as an independent company. Amgen’s global commercial manufacturing and R&D capabilities, especially for biologic products, will enable Horizon’s medicines to reach even more patients more quickly than Horizon could have achieved on its own. As you know, this combination has been approved by regulators around the world, with the exception of the Federal Trade Commission in the United States. The FTC’s arguments in this case are based on speculation and hypothetical notions. Their arguments are not grounded in long established antitrust law. Notwithstanding that in choosing to pursue this case, they’ve ignored the commitments we made to address their stated concerns. Life-changing medicines that Amgen and Horizon offer treat different diseases and different patient populations. Simply put, there are no competitive overlaps and no incentives to bundle our drugs with theirs. We look forward to making our case in court in September and I’m confident rather that we will prevail. In the meantime, we’re working closely on integration plans with Horizon, so we can hit the ground running by mid-December, which is when we anticipate being able to close the deal. And let me just reiterate one more point before I hand over to Murdo. As the second quarter illustrates, Amgen’s business is performing very well and our organic outlook for growth is strong, adding Horizon will serve to enhance our growth prospects even further. And let me close by thanking my Amgen colleagues around the world for their unwavering commitment to patients and to our business. We’re excited about the future and our ability to serve many, many more patients than we do today. Murdo?

Thanks, Bob. I am very pleased with our performance in the second quarter, fueled by a commitment to deliver on our mission to bring innovative products to millions of patients globally. Execution is strong across the business with record quarterly sales for nine brands and robust volume growth across our general medicine, inflammation and hematology-oncology portfolios. Excluding the impact of foreign exchange, second quarter global product sales grew 8% year-over-year. Including the impact of foreign exchange product sales increased 6% year-over-year. Volume growth was 11% with strength across our regions. U.S. volume growth was 9%. And volume growth in our Europe, Latin America, Middle East and Canada region was 8%. And consistent with our international expansion strategy, Asia-Pacific continues to be our fastest growing region with 46% volume growth in the quarter. Starting with our general medicines business, which includes Repatha, Prolia, EVENITY, Aimovig. Overall revenue for these four products grew 19% year-over-year in the second quarter, driven by 21% volume growth. Cardiovascular disease is a growing public health crisis and the state of care for high risk ASCVD patients with elevated LDL cholesterol is poor. Family heart, real world analysis of 38 million high risk Americans revealed that fewer than 30% of them ever reached their recommended LDL levels. This is a clear call to action that lowering LDL cholesterol as much and as early as possible with Repatha will reduce cardiovascular risk for patients. And so to meet this need, I’m Amgen is committed to improving patient’s ease of access and affordability. Today we have best-in-class formulary coverage for Repatha helping 90% of eligible U.S. patients gain access to this important medicine. Improved access is enabling broad adoption of Repatha by cardiologists and increasing adoption by primary care providers. So, this has set the stage for growth for Repatha sales, which increased 30% year-over-year to a record $424 million in the second quarter. In the U.S. volume growth of 34% was driven by a record number of new patients starting treatment. Outside the U.S. we saw 37% volume growth with momentum across our regions. We recognize there are still many more patients around the world who can benefit from Repatha. And to meet that challenge, we are increasing investment to intensify our engagement with healthcare providers, bring our message directly to patients through direct-to-consumer media and drive urgency around LDLC testing and adherence to treatment guidelines. Transitioning to bone health, Prolia sales grew 11% year-over-year to a record $1 billion in second quarter driven by 11% volume growth. As Dave will discuss in more detail new real-world evidence data presented at the World Congress on Osteoporosis in May demonstrates the Prolia significantly reduces fracture risk across multiple endpoints when compared to alendronate. Our sales teams are now equipped with these data and are actively helping physicians understand the superior ability of Prolia to reduce the risk of fracture for their osteoporosis patients. EVENITY, which compliments Prolia in our bone portfolio, had record sales of $281 million for the quarter driven by strong volume growth across markets. In Japan, EVENITY had achieved a 42% share of the growing bone builder market, steadily increasing performance versus competitors and increasing initiation for naïve patients. EVENITY sales are now annualizing at over $1 billion. Given the severe impact of fractures on the lives of women who are post-menopausal our success in Japan, the first launch market for EVENITY enhances our confidence in the significant growth potential through this decade. Otezla sales increased 1% year-over-year driven by 2% volume growth. Otezla remains the only approved oral systemic therapy with a broad indication and is well-positioned to help the more than 1.5 million systemic naïve U.S. patients with milder psoriasis that cannot be optimally addressed by a topical treatment and can benefit from a systemic drug like Otezla. Our U.S. Otezla business has been impacted by free drug programs for newly launched topical and systemic competitors. And we expect new patient demand will continue to be affected by these programs for the remainder of 2023. Despite this, we see a compelling opportunity to invest in growth of Otezla and to drive increased awareness amongst physicians and patients. We are confident in the growth potential of Otezla given its unique combination of established efficacy and safety profile, broad payer coverage with limited prior authorization requirements and a lack of testing required for initiation, and of course, ease of administration. Enbrel sales grew 84% quarter-over-quarter following the seasonal impact on price and large drawdown of inventory during the first quarter in the U.S. Year-over-year, Enbrel sales increased 2% driven by favorable changes to estimated sales deductions and higher net selling price partially offset by lower inventory levels. Although year-over-year volume was flat in the second quarter, the number of new patients in the U.S. starting treatment increased by 6%, driven by improved payer coverage. For the remainder of 2023 we expect this improved coverage will lead to continued growth in new patients. We also expect declining net selling price on a full year basis. Test buyer continues to show robust growth with $133 million in sales in the second quarter. Sales increased 39% sequentially driven by 37% volume growth that benefited from the introduction or self-administered, pre-filled, single-use pen approved by the U.S. Food and Drug Administration in the first quarter. The pen offers patients a convenient option to administer TEZSPIRE at home, which improves accessibility and provides more flexibility and treatment options for all patients in the U.S. with severe, uncontrolled asthma. Sales of TAVNEOS were $30 million in the second quarter. U.S. volumes grew 28% quarter-over-quarter driven by an increase in new patients starting treatment. In the U.S. approximately 2000 patients have now been treated with TAVNEOS by over 1300 healthcare providers. Looking forward, Amgen’s deep experience in inflammation and nephrology and substantial market presence will allow us to bring TAVNEOS to even more patients with ANCA associated vasculitis. AMJEVITA sales increased 29% year-over-year for the second quarter, driven by 60% volume growth partially offset by lower inventory levels and net selling price. U.S. sales decreased 63% sequentially driven by inventory drawdowns after stocking to support a launch in the first quarter, partially offset by volume growth. Moving to our hematology and oncology business, which includes LUMAKRAS, KYPROLIS, XGEVA, Vectibix, Nplate and BLINCYTO. Strong commercial execution and exciting new clinical data drove 12% volume growth year-over-year for these six innovative products. BLINCYTO sales grew 48% year-over-year with adoption across academic community and pediatric centers. Following positive data from the registration enabling E1910 study presented in December of 2022, an updated NCCN guidelines that were issued in May. Both the positive data and the updated guidelines support our confidence in the continued growth potential for BLINCYTO. Vectibix sales increased 20% year-over-year for the second quarter, driven by 20% volume growth supported by promotion of positive data from the Phase 3 PARADIGM trial demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy for patients with wild-type RAS, colorectal cancer. KYPROLIS grew 9% year-over-year driven by 15% volume growth, partially offset by lower net selling price. And LUMAKRAS reported $77 million of sales for the second quarter. Year-over-year sales were flat in the quarters. 20% volume growth was offset by lower net selling price and inventory levels. We see future growth opportunity for LUMAKRAS driven by launches in new markets and our comprehensive global clinical development program. Our execution is strong across the business driving growth and exemplifying our dedication to serving patients. Our business is performing at the very high level and with the announced acquisition of Horizon Therapeutics, we have the potential to serve many more patients who can benefit from our decades of leadership in inflammation and nephrology. And with that, I’ll turn it over to Dave Reese.

Thanks, Murdo. Good afternoon everyone. For R&D, the second quarter was one of high quality execution as we progressed our innovative pipeline with two important data readouts, multiple registration enabling studies on track and additional exciting data coming later this year. Beginning with oncology, we are exceptionally pleased to announce positive top line results from the global Phase 2 DeLLphi-301 trial evaluating tarlatamab, a first-in-class DLL3 targeting BiTE molecule in patients with relapsed or refractory small cell lung cancer that progressed after two or more prior lines of treatment. Tarlatamab demonstrated an objective response rate at the primary endpoint that substantially exceeds what was previously reported in the Phase 1 study. Responses were durable and longer than what is expected with standard of care chemotherapy. Safety and tolerability were also more favorable compared to the Phase 1 study. This is the first time the device-specific T cell engager has shown unequivocal activity in a common solid tumor, a real milestone in the field. We look forward to discussing these data soon with the FDA and other regulatory agencies and presenting detailed results of this potentially registrational Phase 2 study at an upcoming Medical Congress. Based on the data we have observed, we are moving tarlatamab into earlier lines of therapy with DeLLphi-304, a Phase 3 study underway comparing tarlatamab with standard of care chemotherapy and second-line small cell lung cancer. We are also planning to initiate two additional Phase 3 studies of tarlatamab in earlier lines of small cell lung cancer. From my personal vantage point, as an oncologist, I believe this molecule can be transformative and can’t wait to share these data with the field. Turning to LUMAKRAS, we continue to execute on our comprehensive clinical program designed to generate the breadth of data necessary to understand KRAS biology and the role LUMAKRAS can play in non-small cell lung cancer, colorectal cancer, and other solid tumors. We are delighted to announce that the global Phase 3 CodeBreaK 300 trial evaluating LUMAKRAS combined with Vectibix in chemo refractory metastatic KRAS G12C mutated colorectal cancer met its primary endpoint of progression-free survival for both the 240 milligram and 960 milligram doses. At comparable doses, efficacy results were consistent with what was previously observed in this setting with no new safety signals. We look forward to sharing these results with global health authorities and presenting the detailed results at an upcoming Medical Congress. The FDA recently granted breakthrough therapy designation to LUMAKRAS in combination with Vectibix for the treatment of patients with metastatic KRAS G12C mutated colorectal cancer as determined by an FDA approved test who have received prior chemotherapy based on data from the prior CodeBreaK 101 study. Beyond these data, we continue to explore novel combinations as we seek to move LUMAKRAS into the first-line setting. Recently presented data from the SCARLET study provide the rationale to initiate a Phase 3 trial of LUMAKRAS combined with chemotherapy in first-line non-small cell lung cancer patients with PD-L1 negative tumors and Phase 1b data in combination with Vectibix and chemotherapy support the initiation of a Phase 3 study of LUMAKRAS with Vectibix and FOLFIRI in first-line G12C mutated colorectal cancer. In June, the FDA approved the supplemental biologics license application for BLINCYTO for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1%. The approval converts BLINCYTO’s accelerated approval to a full approval. Global regulatory submissions are on track for E1910, a Phase 3 trial conducted by the National Cancer Institute, Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network, Cancer Research Group that demonstrated superior overall survival with BLINCYTO treatment added to consolidation chemotherapy over standard of care consolidation chemotherapy in newly diagnosed adult patients with Philadelphia negative ALL who were MRD negative following induction and intensification chemotherapy. Three important updates were made to the National Comprehensive Cancer Network clinical practice guidelines in oncology in B-cell ALL. These included listing the BLINCYTO E1910 regimen as the only preferred regimen for the first line treatment of Philadelphia negative adult patients adding BLINCYTO to multi-agent chemotherapy as consolidation in MRD negative disease. And lastly, moving BLINCYTO in combination with a tyrosine kinase inhibitor to the top of the treatment algorithm or MRD negative Philadelphia positive disease. Finally, in April, data were published in the New England Journal of Medicine demonstrating that BLINCYTO added to chemotherapy improved two-year survival in KMT2A-rearranged B-ALL in infants as compared to historical data, BLINCYTO two-year survival was 93% versus 66% or chemotherapy alone. If you look at the totality of the data, it is clear that BLINCYTO is changing the paradigm for the treatment of B-cell ALL in late-stage disease, in early disease, in young patients and in older patients. We remain excited about its future potential and are focused on further investigating BLINCYTO in earlier lines of treatment and improving patient convenience through subcutaneous administration. As the first BiTE [ph], BLINCYTO also provides a roadmap for the development of molecules such as tarlatamab, which could have enhanced activity in settings of lower tumor burden. Two additional early oncology programs to watch are Xaluritamig and AMG 193. Xaluritamig is a first-in-class steep one targeting bispecific being studied in advanced prostate cancer where steep one is expressed on almost all tumor cells. We are observing significant anti-tumor activity with this molecule and are rapidly enrolling dose expansion cohorts. Xaluritamig provides another example of a bispecific T-cell engager demonstrating activity in a solid tumor setting. AMG 193 is a first-in-class small molecule MTA cooperative PRMT5 inhibitor being studied in patients with advanced MTAP-null solid tumors. The overexpression of PRMT5 in the absence of MTAP leads to the accumulation of MTA and we leverage this biology in the unique design of AMG 193, which requires the presence of MTA to effectively inhibit PRMT5. Alterations in this pathway occur approximately 15% of solid tumors are often associated with a poor prognosis and historically have been very hard to drug. We are currently enrolling a Phase 1b/2 study of AMG 193, and while it is early, we are encouraged by the anti-tumor responses we’ve observed in multiple tumor types. We look forward to sharing data from both Xaluritamig and AMG 193 this fall. In general medicine, we are advancing our cardiovascular franchise and emerging portfolio of obesity molecules with a focus on clinical trial execution. The Phase 3 outcomes study of Olpasiran are potentially best-in-class Lp(a) targeting small interfering RNA molecule and atherosclerotic cardiovascular disease is enrolling well as is a Phase 2 study of maridebart cafraglutide formerly known as AMG 133 in patients with obesity with or without diabetes and related comorbidities. The goal of the Phase 2 study is to generate data that will provide broad optionality to design a Phase 3 program leveraging the unique properties of maridebart cafraglutide that will deliver strong sustainable weight loss. In May, as mentioned, we presented data from a real world study of nearly half of a million post-menopausal women with osteoporosis in the United States Medicare program showing Prolia substantially reduced fracture risk in patients versus oral alendronate. In addition, the same study showed that longer duration of Prolia treatment was associated with a greater reduction in major osteoporotic fracture risk. These data are a great demonstration of the importance of Prolia in treating post-menopausal osteoporosis and the ability to study treatment effects in large patient populations using real world evidence. In inflammation beyond severe asthma, we are investigating multiple additional indications with TEZSPIRE including separate Phase 3 studies in chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis. We also have two Phase 2 studies, one in chronic spontaneous urticaria and the other in COPD. The CSU study is complete with top line data anticipated in imminently. The COPD trial is fully enrolled and has recruited a broad population of COPD patients, including patients with both high and low eosinophil counts. We look forward to the readout of this study in the first half of 2024. Rocatinlimab first-in-class anti-OX40 monoclonal antibody being investigated in patients with moderate to severe atopic dermatitis. Recruitment is off to a strong start on the ROCKET Phase 3 clinical development program. We are also planning to initiate a Phase 2 study in moderate to severe uncontrolled asthma as we explore rocatinlimab in this additional indication. Rounding out the clinical summary, we’ve continued to execute those on time and on budget with our biosimilars portfolio, including the recent initiation of a pivotal study evaluating the pharmacokinetic similarity of ABP 206 compared with OPDIVO one of six planned new biosimilars. In closing, I’d like to highlight our recently announced collaboration with TScan Therapeutics. This is a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan to identify the antigens recognized by T-cells in patients with Crohn’s disease and represents a novel approach to investigating this tough to treat illness. I’d like to thank Amgen staff around the world for their relentless focus on execution as we work hard to meet the needs of the patients we serve. I’ll now turn it over to Peter.

Thank you, Dave. We’re pleased with our strong second quarter performance. Growing volumes by 11% increasing investment in research and development and delivering 8% year over year non-GAAP EPS growth. This drives our confidence in delivering against our 2023 objectives and keeps us in position to meet or beat our longer term commitments. I’ll review our second quarter results before discussing our 2023 guidance. As a reminder, these results and outlook reflect Amgen on a standalone basis without any adjustments for the announced Horizon acquisition. Turning to our second quarter financial results, which are shown on Slide 41, total revenues of $7.0 billion grew 6% year-over-year and represent the highest quarterly revenues in Amgen’s history. Product sales increased 8% while total revenues increased 7% year-over-year, excluding the negative impact of foreign exchange rates. Second quarter total non-GAAP operating expenses increased 7% year-over-year. We invested in and advanced our pipeline and accelerated growth across our priority marketed products, while delivering a non-GAAP operating margin as a percent of product sales of 52.6%, demonstrating expense discipline. Non-GAAP R&D spend in the quarter increased 7% year-over-year, reflecting growing investments in our pipeline, driven by higher spending on late stage programs and marketed product support. Non-GAAP cost of sales as a percent of product sales increased 2.4 percentage points on a year-over-year basis to 17.1%, primarily driven by higher profit shares and a changes in product mix. Non-GAAP SG&A expenses in the second quarter decreased 6% year-over-year. We continue to focus on our continuous improvement operating model, prioritizing investments, digitalization and driving productivity and beginning and in other cases continuing. What we have already started historically to execute in any number of uses of artificial intelligence. Non-GAAP other income and expenses were a net $307 million expense in the second quarter. This year-over-year favorability was driven primarily by the change in Beijing accounting from equity methods to a mark-to-market investment with the impact included only in our GAAP results. As expected, our second quarter non-GAAP tax rate increased 1.7 percentage points to 16.4%, primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023. We continue to execute on our capital allocation priorities. First, we continue our priority investments in the best innovation, both internal and external innovation. In Q2, we drove higher spend in late stage programs, such as AMG 133 an olpasiran as well as support for our marketed products, including [indiscernible] Second, we continue investing in our business. Capital expenditures are at near peak levels driven by simultaneous construction of our state-of-the-art manufacturing facilities in Ohio and North Carolina. We expect our annual capital expenditures to begin to decline starting in 2024 with the completion and licensing of our Ohio plant and capital expenditures will then begin to return closer to historical levels over the coming years. And third, we plan to continue to return capital to our shareholders. We pay dividends of $2.13 per share in the second quarter, representing a 10% increase over the second quarter of 2022. The company generated $3.8 billion of free cash flow in the second quarter of 2023 versus $1.7 billion in the second quarter of 2022, primarily driven by the timing of tax payments and includes higher interest income and higher operating income. We expect strong cash flow for the remainder of the year, consistent with our full year 2023 financial outlook and includes a non-GAAP operating margin of roughly 50%. Now turning to the outlook for the business for 2023 on Slide 43. Our guidance is currently provided on the Amgen standalone business and does not include any Horizon projections. As the Horizon transaction is expected to close by mid-December, resulting contributions from Horizon would be included after that period. Given our strong performance, we are raising our 2023 revenue guidance to $26.6 billion to $27.4 billion versus previous guidance of $26.2 billion to $27.3 billion. Although our results give us confidence to raise our full year guidance, we expect the third quarter sales maybe lower compared to the second quarter, due to the impact of the Medicare donut hole, which is more pronounced in the second half of the year, and also to certain favorable changes to estimated sales deductions in the second quarter. Regarding our non-GAAP earnings per share guidance, we intend to increase investments in our internal innovation and priority marketed products from a position of strength, given the acceleration in our business and our pipeline, reflecting our improved revenue outlook along with our investment plans we are revising our non-GAAP EPS guidance to $17.80 to $18.80 versus previous guidance of $17.60 to $18.70. Again, although our results give us confidence to raise our full year non-GAAP EPS, we expect third quarter non-GAAP EPS to be lower compared to the second quarter, resulting from the expected Q3 sales and our investments in the business. Important additional points to consider as you model the remainder of 2023, we now project full year Neulasta sales of approximately $800 million and full year combined KANJINT and MVASI sales of approximately $900 million. We now expect other revenue for 2023 to be in the range of $1.1 billion to $1.3 billion versus our prior range of $1.2 billion to $1.5 billion. Note that our third quarter 2022 results included about $90 million of other revenue related to our COVID antibody manufacturing agreement and the milestone we earned that we do not expect to repeat in the third quarter of 2023. We anticipate full year non-GAAP operating expense for 2023 to increase by closer to 3% versus last year compared to our previous estimate of a 1% increase with higher cost of sales from projected increase sales, additional investments driving our innovative pipeline and increase support for our growing priority marketed products, including Repatha and Otezla. We continue to expect a full year 2023 operating margin as a percentage of product sales to be roughly 50%, although will vary in each of the remaining two quarters. We continue to expect non-GAAP cost to sales as the percentage of product sales will be between 16% and 17%. We now expect our non-GAAP R&D expenses in 2023 to increase about 5% year-over-year, which is higher than our prior guidance of 3% to 4%. We continue to expect non-GAAP SG&A spend to be slightly down year-over-year as a percentage of product sales. We now expect non-GAAP other income and expenses to be in the range of $1.1 billion to $1.2 billion down from the prior guidance of $1.2 billion to $1.3 billion. For the full year, we anticipate a non-GAAP tax rate of 17.5% to 18.5% down from prior guidance of 18.0% to 19.0%. We expect Q3 tax rate to be near the upper end of the revised range of 17.5% to 18.5%. Our capital expenditure guidance remains unchanged at approximately $925 million in 2023. Our confidence is strong in the long-term outlook and long-term growth for Amgen, and we look forward to completing the announced acquisition of Horizon by mid-December as Bob indicated. I’m incredibly grateful to our 24,000 plus colleagues for successfully executing on our mission of serving patients in the second quarter and beyond. This concludes the financial update. I’ll turn it over to Bob for Q&A.

Okay. Thank you, Peter. And now we’ll open the line for callers so they can ask questions. And I just ask our operator to remind you of the procedures for doing that, please.

[Operator Instructions] Our first question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Great. Thank you very much for taking my question and congrats on the quarter. Maybe one question on OX40. There are some concerns and people are talking about the safety of OX40. Like one concern is regarding the autoimmune phenomena, and I’m reading some literature and suggests that in OX40 – lacking OX40 animal models, there is an impairment of interferon gamma. So just trying to understand how are you managing that risk in this particular drug? And how is it – what we mean phenomena? Is it a concern at all there? Thank you.

Yes. Thanks. This is Dave. So we’re aware of those conversations. What I can tell you is that let me approach your question in two parts. One mechanistically, OX40 is primarily expressed on activated T cells and activated pathogenic T cells in the setting of atopic dermatitis. In the Phase 2 program, we did not observe autoimmune phenomena. Obviously, this is something we are tracking, but we have no clinical signal or indication of such concerns at this time. Likewise, your question regarding interferon gamma would imply risk, for example, for infections. That’s also something that we did not see at a greater rate in treated patients than placebo in the Phase 2 program. These are things that we will follow, they’re followed routinely for almost all cytokine inhibition programs. But to date, we have not had signal.

Thank you, Mohit. Our next question comes from Michael Yee from Jefferies. Please go ahead. Your line is open.

Hey guys, thanks for the question. Bob commented about the enthusiasm for the Horizon deal. I know in general there’s a lot of uncertainty in the TED market going on with sales. Can you maybe just describe your ongoing confidence with what you think is going on in the TED market, why you’re excited about this and your confidence around regrowing this business? And have you been in discussions or at least aware of the ongoing dynamics or at least an ongoing dialogue with the company about the market for TED? Thank you.

Yes. Sure, Mike. We can answer in two parts. Maybe I’ll kick it over to Murdo in a moment. But let me just reiterate that we remain very excited and of course, we’re watching carefully developments in the marketplace and talking as appropriate with our friends at Horizon about that. And again based on our view of the clinical data and our view of the international opportunities and ability to expand the reach of the product, we’re very excited about what we think we can do there. But Murdo, why don’t you elaborate further.

Yes. From our vantage point, Mike, what we see is strong execution by the Horizon team in the U.S. and there’s several catalysts for growth here. They’ve already expanded their commercial footprint, and so that should start to take traction. They have the data now for the low CAS patient population with the positive results from that trial in public domain, not yet published, but in public domain having been presented and in hand with their sales forces. So that’s very recent and not reflected necessarily in their historical performance. Bob mentioned the international market launches. We continue to believe post-close, we will be able to help accelerate the work being done there. We’re also seeing some improved medical policies being issued prior to the new calendar year and so that’s very encouraging to see payers improve or remove restrictions, I should say, on the use of TEPEZZA for the lower CAS patient population. So there are many good catalysts, and what I see is horizon systematically unlocking those additional opportunities for growth, and we remain quite bullish on TEPEZZA’s utility across a very large population of thyroid eye disease patients who would benefit from that treatment given the clinical data. The last thing, I should mention on TEPEZZA is they also were able to replicate the low cast population results in OPTIC-J, in their OPTIC-J trial. Sorry, they’re not the low cast, but the registrational data for thyroid eye disease in OPTIC-J. So that sets them up well for future potential launch in Japan. So really good data flow, really good execution and investment and focus here. And look beyond TEPEZZA. We also remain very, very excited about their other two large inline brands with KRYSTEXXA and obviously UPLIZNA. So overall, we remain excited and confident that the two companies working together on this really strong portfolio will be a good parent.

Thank you, Michael. Our next question comes from Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Good afternoon. Thanks for taking my question. Could you put the top-line Phase 2 data for tarlatamab in small cell lung cancer into context for us, and share any more details on the profile. In particular, how does this compare to the Phase 1 data where you had a confirmed objective response rate of 23% in a median duration of response of 13 months? I think you noted it substantially exceeds the Phase 1 results. Thank you.

Yes, Salveen, thanks for the question. Very, very excited about this small molecule. If you step back, I think, it represents what we had hoped to see in the BiTE platform and substantial clinical effects in a major solid tumor. To put the data in the context in comparison to a Phase 1, as noted, we substantially exceeded the 23% response rate that we reported in Phase 1. We are planning to present these data at a Fall Conference on embargoed in terms – of course, in terms of providing more specifics. But I can tell you that it couldn’t be more pleased with the response rate data, the duration of response, and overall survival. For context in patients with small cell lung cancer in the third-line response rates are typically well under 50%, but importantly, they are vanishingly brief in most instances, often a matter of weeks or a few months. And so, based on what we’re observing, I think we really have a chance to change the natural history of this disease, particularly as we march towards earlier lines of therapy where the activity of the BiTE in a lower tumor disease burden setting should be enhanced as we have observed with BLINCYTO. So all of our efforts now are focused on executing earlier line trials. So, this is one to I think pay attention to as we go forward and we’re really looking forward to presenting these results this fall.

Dave, you want to say anything about safety? Obviously …

I’m sorry. And in terms of the safety, I think we have learned a lot in the development program about the clinical management here. We’re quite pleased with the rates of principal side effects, like cytokine release syndrome and we’re – we’ll look forward to sharing those details as well when we present the data this fall. But exceptionally happy with the tolerability and safety profile as well.

Thank you, Salveen. Our next question comes from Jay Olson with Oppenheimer. Please go ahead. Your line is open.

Oh, hey, congrats on the quarter and especially the tarlatamab and LUMAKRAS results. And happy birthday to Arvind.

Thanks.

For the LUMAKRAS Phase 3, in colorectal cancer. Can you just talk about the filing strategy and timeline, and maybe a little bit about the market opportunity in CRC for LUMAKRAS? Thank you.

Yes. In regards, this is obviously a smaller patient population, about 4% of colorectal cancers harbor the G12C mutation. In terms of next steps here our plans are to have discussions with the FDA and other regulatory authorities on these Phase 3 data. And as those conversations on unfold, I’ll provide guidance about the potential regulatory pathway. And then, as I mentioned, based on the strength of these data and Phase 1b data in the first-line setting using a Vectibix chemotherapy LUMAKRAS combination we are also advancing a Phase 3 trial in first-line disease. So, I think its full steam ahead in colorectal cancer as well. And again, I’ll give guidance about next steps as we’ve had the appropriate conversations.

Thank you, Jay. Our next question comes from Chris Raymond from Piper Sandler. Please go ahead. Your line is open.

Thanks. And warm birthday wishes to Arvind from us here at Piper as well. Just a question on am AMJEVITA. So, obviously the uptake in the U.S. has not been maybe what was originally sort of contemplated, when you guys were first talking about that opportunity. But maybe a couple questions. Can you maybe talk about first maybe the split in scripts between the high and low priced SKU. And then second, maybe there’s been a lot of talk around what AbbVie has done to sort of blunt uptake, biosimilars to date. What, if anything on their part has surprised you guys, maybe the most in terms of what they’ve done and what’s the plan maybe going forward?

Sure. Yes. Do you want to take that, Murdo?

Sure. Thank you for the question, Chris. We’re obviously very early innings still in this biosimilar market with AMJEVITA, and we’re seeing clearly what is new payer behavior in light of such a large product having biosimilar competition. With respect to the high versus the low, we’re – it’s kind of a different mix. We see mostly the high in PBM utilization and the low in the IDN utilization where the low cost – low net cost is attractive to them. But again, it’s very early in the product mix, I don’t think has settled out yet between those two SKUs. I would also say that we are still waiting to see what happens in the next payer negotiation cycle going into 2024. As you’ve seen many of the PBMs are on record as saying that they haven’t done a whole lot in terms of driving utilization of biosimilars in 2023, but plan to do more of that in 2024. So I think there’s a lot more to follow here. And with respect to AbbVie strategy, look, we compete against them in the innovative site and we now compete against them with our biosimilar, and we know their practices well. So not a lot of surprises there, but I think the – I think that the clarity of how pharmacy benefit works with biosimilar uptake, or lack thereof is becoming clear to us and to other biosimilar manufacturers and other onlookers. So more to follow there. I would say though, we remain very excited about the growth of biosimilars in the longer term. We continue – as Dave mentioned, we continue to commit research investment in the development of additional biosimilars with most recently with the initiation of ABP 206, a biosimilar to OPDIVO. We also are continuing to look at being able to launch other biosimilars in the medical benefit reimbursement system in the U.S. and that’s where we were successful, obviously with KANJINTI and MVASI in our previous launches. So going forward, the majority of our biosimilar growth will come from ex-U.S. and U.S. medical benefit biosimilars. And we continue to believe we’ll be able to generate strong growth. Having previously said that we would more than double our 2021 annual sales of roughly $2 billion.

Thank you, Chris. Our next question comes from Umer Raffat from Evercore ISI. Please go ahead. Your line is open.

Hi guys. Thanks for taking my question. And Dave, I felt like you were on a roll on Arvind’s birthday today, so congrats on all the data. My question is three and a half month was the PFS in the prior data, I think it was 20 plus percent response rate. And judging by the way you were describing it as transformative, is it fair to say PFS also improved in a meaningful way in the DL3 study? And secondly back on the horizon deal, I feel like two things are clear. You’re very committed to the deal, but also that TEPEZZA is falling dramatically short at least so far. And the question that’s coming up from investors is, is there any way to renegotiate the purchase price? Thank you very much.

Yes. What I can say Umer, without getting into specifics on the number being under embargo is that I’m very happy with the overall – the efficacy package – overall response rate, progression-free survival, duration of response, and overall survival. And we’ll have presentation of all of those data at an upcoming medical Congress. But to me this is – it’s a very, very compelling efficacy package.

Okay. And on horizon, Umer, you’re right, we remain enthusiastic about proceeding on the basis of the deal that we announced. I would take issue at least with our perspective is different from what was implicit in your question, but we’ll leave that for another day.

Thank you, Umer. Our next question comes from Yaron Werber from TD Cowen. Please go ahead. Your line is open.

Great. Thanks for taking the question. I have a question on OTEZLA and sort of as relating to Enbrel too, specifically, Enbrel sort of bouncing back, which is good to see. It looks like that’s really a net benefiting from the contracting that you’ve put in place given AMJEVITA and generic Humira. OTEZLA though is facing SOTYKTU, which is actually doing pretty well in terms of uptake. It’s got a benign label and obviously a drug program. What gives you a lot of confidence in the outlook ahead? Thank you.

Thanks Yaron for the question. Yes, you’re right. Enbrel has – did have a strong quarter and is benefiting from quite frankly, the best access we’ve ever had on Enbrel, where we’re covered across all the major PBMs now. So we’re seeing really nice new patient growth on Enbrel, so more new patients coming onto treatment with Enbrel, and we think that that will support sustained volume through the course of the year. We did give up a bit of price to do that, so that’s also flowing through Enbrel. But overall, I think there was some concerns perhaps last quarter that the biosimilar activity in this category was somehow impacting Enbrel. And I was pretty clear last quarter that wasn’t what we were seeing. And it’s definitely now clear in second quarter that biosimilar competition for Humira is not negatively impacting Enbrel. So we’re – we see stability in Enbrel going forward. For OTEZLA, we’re actually seeing some strength in OTEZLA. We are pleased with what new patient acquisition looks like. We think we can do better and we – as I mentioned in my prepared remarks, are investing more in OTEZLA through the backend of this year. And Peter also mentioned that. And the reason we’re optimistic is we’re gaining momentum in helping those post topical first systemic patients. And the epi here is pretty significant as there’s 1.5 million of these patients in the U.S. that persist with topical treatment. That would be better being initiated on a systemic agent. And OTEZLA is really the ideal for a systemic agent. We have great commercial coverage with OTEZLA with very little prior authorization requirement. We have no testing requirement for initiation. And the affordability and out-of-pocket is very good. So OTEZLA is an attractive option for PBMs and pairs to maintain on their formularies. And it’s an easy option for dermatologists as the first systemic agent that they would choose for a patient coming off the topicals and being treated. And again, this is milder form of disease and no one else has indicated for that mild population from a systemic perspective. So overall, the thesis is good. Now, I think, SOTYKTU coming into the market clearly put pressure on us where there were patients who were probably on our oral and didn’t have full resolution of their psoriasis symptoms and they would’ve switched to SOTYKTU. What we’re seeing is that, that has slowed. We are losing less to SOTYKTU in our current mix of patients that we have on Otezla. And we think that the other – the other dynamic that put pressure on us in the first part of the year was the topical treatments also had free goods programs out there, and they were getting trial, and that has abated, they flattened out. So we’re getting less pressure from topicals and much less patient movement away from Otezla to SOTYKTU. So I think we really have to see into 24 how the access will evolve for the novel agents, but we’re very confident with our current access and the current perception of the safety and efficacy of Otezla, we can further penetrate that population of patients. So going forward, we’re feeling good about it.

,:

Great. Thanks. Thanks guys. Congrats on the quarter and thanks for taking my question. Bob, we certainly appreciate you framing up the case for the Horizon deal before the eyes of regulators and the courts. And maybe just to build on the conviction that, that you laid out, I just wanted to ask on your thoughts on the implication to potentially a negative outcome on the biopharma, value creation, ecosystem and essentially the ability for companies like Amgen to, to bring medicines to patients. So if we just call it that this novel legal theory like bundling does prevail what impact would that have? And maybe to that, how far would you and the Amgen team really be willing to take this to preserve that opportunity to close the deal? Thanks so much.

Well, again, I think I would reiterate what I said in my prepared remarks, right, which is that they, we don’t believe that their case is based on any established antitrust law. We think it’s based on hypotheticals and speculative notions. And we look forward to having a chance to assert that in court. And again, we expect to prevail in court. And I think what – what’s implicit in your question is the recognition that we live in a very fragmented industry, and that there are a lot of innovators in particular that are a size that makes it difficult for them to capitalize on the full potential of their innovation, especially globally. And so there is a role for companies like ours to play in bringing value to companies like Horizon. We’ve talked about it repeatedly, but we think the capabilities we have with our global commercial organization that demonstrated expertise we have in manufacturing, research and development for products like this, I think will enable us to reach far more patients than the company would be able to on its own. So this is an industry that has flourished by being able to capitalize on the innovation ecosystem that exists for biotechnology companies, for the most part in the United States. And again, we expect that that will continue and think that were it not possible for companies to combine to benefit from each other’s strengths, the result would be fewer innovation, reaching fewer patients. So that would be an unfortunate outcome.

Thank you, Gregory. Our next question comes from Evan Seigerman from BMO. Please go ahead. Your line is open.

Hi guys. Thank you so much for taking my question. Maybe one for you, Dave; can you just expand on the biologic rationale to target steep one versus PSMA and prostate cancer? And I’m asking this in context of an update you we had from a competitor today, whereas their PSMA program different than yours, they had to modify significantly due to safety issues? Thank you very much.

Yes. Thanks Evan. We’re – so a couple reasons to target steep one. Number one it’s almost universally expressed on advanced cancer cells. There is not e extensive high level normal tissue expression, so that allows you to generate the therapeutic window that we’re always looking for with bispecific T-cell engagers. PSMA has been a challenging target. There appear to be unique properties with that target. As I think you’re aware, multiple molecules including some of our own have gone into and then fallen out of clinical development. And I’ve come to the belief that that maybe in part target related. So steep one is a relatively novel target, we are in the clinic, I think are far advanced compared to anyone else. And based on the clinical data that we’re seeing now, this is a program we really want to accelerate. This is another one of the programs where, we’ll be presenting data this fall and either urge you to put [indiscernible] under the radar screen and pay attention to those data; but this one I think has a real opportunity.

Thank you, Evan. Our next question comes from Colin Bristow from UBS. Please go ahead. Your line is open.

Hey, good afternoon, and thanks for clicking the questions. Maybe just a quick one on TEZSPIRE, and you have the upcoming COPD data in the first half of 2024. I was just curious as to get your expectations here. What’s the threshold for success, especially in light of the recent sort of very positive [indiscernible] data? Thank you.

Yes. I think in light of what we’ve seen in the field, we would love to see something that is competitive with that. Just to level set everyone, the rationale for this study is that the target of TEZSPIRE, TSLP is expressed in bronchial mucosa. Sputum can be detected in bronchoalveolar lavage fluid in patients with COPD. The pathway may be a contributor or driver of exacerbations and that’s really the hypothesis that we are testing here. So we’ll look at the totality of the clinical data, but I think some of the things you’ve seen recently published give us benchmarks as to what we’ll hope to see.

Thank you, Colin. Our next question comes from Dane Leone from Raymond James. Please go ahead. Your line is open.

Thank you. Maybe just two quick ones for me; firstly, in terms of the rebound in Otezla and the good strength that seems to be coming out of some of those trialing periods for competitive products on the topical side and also oral side. Can you just maybe provide whatever response makes sense to your competitors’ analysis on the oral side suggesting they’ve achieved over 40% TRx share and whether you think that share could go back in favor of Otezla during the back half of this year, or is that something you would see steady state from here on out? And then secondly, just regarding the Phase 2 tarlatamab, is there anything we need to be aware of that maybe the patient population in this Phase 2 small cell lung cancer study, was maybe less heavy or pre – less heavily pretreated as opposed to what was seen in the Phase 1 study, which is sometimes the case? Thank you.

Yes, why don’t we take it in two parts?

Yes. Dane, I’ll attempt to answer your Otezla question. As I said, we are encouraged by what we’re seeing in the market here. It’s really hard for me to comment on market share claims from other companies, particularly when that they’re adding what we can see versus what we can’t see in their free drug program. So they’re giving a lot of product away, and I think they’re including that in their denominator when they’re providing share. I actually don’t think that’s going to be reflective of what their ultimate in market performance will look like, because we’ve seen that in many categories where free programs or bridging programs are not representative ultimately of the final access picture and the final effect that new access picture will have on demand. So, I think that given our very good access coverage with little to no prior authorization requirements across many of those plans, we are definitely in a position should some of those free drug patients end up getting rejected for sustained actual insurance coverage. Because of the broad coverage, we have not factored that into our go-forward, but it could happen.

Regarding tarlatamab, no substantive differences, very heavily pretreated our population. We’ll provide details this fall.

Thank you, Dane. Our next question comes from David Risinger from Leerink Partners. Please go ahead. Your line is open.

Yes, thanks very much. Could you please provide an update on your oral obesity Phase 1 trial, and also discuss your evaluation of backup candidates? Thanks very much.

Yes, in terms of the oral obesity program, it’s moving through, it’s Phase 1, which includes, single dose and short-term multiple dose. We expect probably now to have data in the first half of next year. Behind that we have multiple programs looking at orthogonal mechanisms of action, many of them non-incretin based. And as some of those progress towards the clinic, we’ll start to talk about them and give you insights into our portfolio approach here. So thank you.

Hey, Julian, why don’t we take one last question as we are over our allotted time?

Certainly. Our final question will come from Robin Karnauskas from Truist Securities. Please go ahead. Your line is open.

Great, thank you. So congratulations on tarlatamab, or I’m going to call TMAb to make my life easier. But can you just opine a little bit, usually first, the first innovators expand a market like small cell to be much bigger than what people think of today. And walk us through the cadence of these Phase 1 trials in particular, I think the checkpoint inhibitor combination trial, like when could we see data from that and how do you view like even Harpoon, the competitive landscape and how you are differentiated from them? Thanks so much.

Sure. Let me start with the tarlatamab [ph]. I’m extremely enthusiastic about this molecule, you know, as always, I’ll let others talk about their molecules. But, this one is one that we’re really putting muscle behind to sort of level set everyone here. As you start to think about the unmet medical need, there are roughly 240,000 cases of lung cancer in the United States each year. Roughly 15% of them are small cell lung cancer, comparable numbers in Western Europe for example. So that gives you a sense of the patient numbers. The clinical development program overtime is going to be designed to look at really that broad swath of patients. Of course, we’re starting in third-line therapy, but our goal here is to quickly advance into second and earlier lines of treatment. And, we’ll talk more about those clinical studies as we get through later in the year. But this is one again, where I think when we get into settings of lower tumor burden as we’ve observed with BLINCYTO, we can really affect the natural history of the disease. Recall that upon initial diagnosis, only 7% of patients with small cell lung cancer will be alive five years later. And that’s the opportunity to change that, I think is in front of us now.

Okay. Well, thank you for your question Robin, and thank you all for joining. As Arvind said, we know we’re a couple minutes over allotted time, so I want to be respectful of your calendars, but I also just do want to make one more statement, if I may, which is before we break, I wanted to announce that after nearly 19 years in the role Arvind Sood will be transitioning his Head of IR responsibility to our Treasurer, Justin Claeys. And Arvind will remain a VP in Finance and will help Justin transition seamlessly into this new role. So he is, while he is not leaving this is nonetheless a big moment and I wanted to acknowledge it because I know Arvind is something of a legend and a fixture in the investor relations world. And I – on a personal note, I want to just add that I’ve worked with Arvind now for more than 20 years. So we began working together even before we both joined Amgen. So I want to publicly congratulate him on his accomplishments in the IR profession. And I want to again, publicly state that I’m delighted that he’s going to remain part of the finance group working with me and Peter and the rest of the team. So on his birthday, we have a second thing to celebrate, which is the culmination of nearly 19 years in his role at Amgen. And those of you, who haven’t met Justin, will enjoy getting to know him. He’s been with Amgen for more than 20 years and served as our Treasurer for most of the past four years. So I know you’ll all join me in wishing Justin well as he begins his transition into this role. And I know you’ll all join me in wishing Arvind a good celebration here with us later this evening. Thank you. We’ll talk to you after the next quarter.

Great. Thank you everybody. And we’ll keep in touch.

This concludes our 2023 Q2 earnings call. You may now disconnect.