Amgen Inc.

My name is Julie Ann and I will be your conference facilitator today for Arabgen'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 speaker's prepared remarks. In order to ensure that everyone has a chance to participate, we would like to request that you limit yourself to asking 1 question during the Q&A session. To ask a question, please press star from the number 1 on your telephone keypad. To withdraw your question, please press that one again. I would now like to introduce Arvin Sude, Vice President of Investor Relations. Mr. Sude, you may now begin.

Thank you, Julie Ann. Good afternoon, everyone, and welcome to all 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 posted. Through the course of our discussion, 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. So with that, I would like to turn the call over to 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 long-standing 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 a billion dollars 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's 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 elendronate, the most frequently prescribed dysphosphonate 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 elendronate. That's superior. Prolia and Aventide, 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 Reiss, we're sharing positive data today for our bite tarlatamab in small-cell lung cancer and for lumicras in combination with Vectabix 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 lincido. Elsewhere in our pipeline, we continue to advance registration-enabling trials for several potential new -in-class medicines, including lopazirane and heart disease, bocatinamalmab and atopic dermatitis, and of course, femurotuzumab and 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. The 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. 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'm 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. US 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 medicine business, which includes Repatha, Prolia, Veneti, and Amavig. 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 growing. Family Heart, real world analysis of 38 million high risk Americans, revealed that fewer than 30% of them ever reach 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, Amjen is committed to improving patients ease of access and affordability. Today we have best in class formula coverage for Repatha, helping 90% of eligible US 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 US volume growth of 34% was driven by a record number of new patients starting treatment. Outside the US 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 LDL testing and adherence to treatment guidelines. Transitioning to bone health, proly 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 presented at the World Congress on osteoporosis in May demonstrates that prolia significantly reduces fracture risk across multiple endpoints when compared to Alendronae. 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. Venity, which complements our bone portfolio, had record sales of $281 million for the quarter, driven by strong volume growth across markets. In Japan, Venity has achieved a 42% share of the growing bone builder market, steadily increasing performance versus competitors, and increasing initiation for naive patients. Venity sales are now annualizing at over $1 billion, given the severe impact of women or postmenopausal. Our success in Japan, the first launch market for Venity, enhances our confidence in the significant growth potential through this decade. Otesla sales increased 1% year over year, driven by 2% volume growth. Otesla remains the only approved oral systemic therapy with a broad indication and is well positioned to help the 1.5 million systemic, naive US patients with milder psoriasis that cannot be optimally addressed by a topical treatment and can benefit from a systemic drug like Otesla. Our US Otesla 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 Otesla and to drive increased awareness amongst physicians and patients. We're confident in the growth potential of Otesla given its unique combination of established efficacy 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 US. 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 US 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. TESPAIR 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 self-administered, pre-filled single use pen approved by the US Food and Drug Administration in the first quarter. The pen offers patients a convenient option to administer TESPAIR at home, which improves accessibility and provides more flexibility and treatment options for all patients in the US with severe uncontrolled asthma. Sales of TABNEOs were $30 million in the second quarter. US volumes grew 28% quarter over quarter driven by an increase in new patients starting treatment. In the US, approximately 2000 patients have now been treated with TABNEOs by over 1300 health care providers. Looking forward, Amgen's deep experience in inflammation and nephrology and substantial market presence will allow us to bring TABNEOs to even more patients with Anka-associated vasculitis. Amgivita 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. US sales decreased 63% sequentially driven by inventory drawdowns after stocking to support the launch in the first quarter, partially offset by volume growth. Moving to our hematology and oncology business, includes Lumacraz, Caprolis, Exchiva, Vectabix, Endplate 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 and updated NCECN guidelines that were issued in May. Both the positive data and the updated guidelines support our confidence in the continued growth potential for Blincyto. Vectabix sales increased 20% year over year for the second quarter driven by 20% volume growth, supported by promotion of positive data from the phase three paradigm trial demonstrating the superiority of Vectabix over Bevacizumab in combination with chemotherapy for patients with wild type RAS colorectal cancer. Caprolis grew 9% year over year driven by 15% volume growth, partially offset by lower net selling price. And Lumacraz 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 Lumacraz 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 a 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. With that, I'll turn it over to Dave Reiss.

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 two Delphi 301 trial evaluating Tarlatumab, a first in class DLL3 targeting bite molecule in patients with relapsed to refractory small cell lung cancer that progressed after two or more prior lines of treatment. Tarlatumab demonstrated an objective response rate at the primary endpoint that substantially exceeds what was previously reported in the phase one 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 one 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 two study at an upcoming medical congress. Based on the data we have observed, we are moving Tarlatumab into earlier lines of therapy with Delphi 304, a phase three study underway comparing Tarlatumab with standard of care chemotherapy and second line small cell lung cancer. We are also planning to initiate two additional phase three studies of Tarlatumab in earlier lines of small cell lung cancer. For 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 Lumacras, we continue to execute on our comprehensive clinical program designed to generate the breadth of data necessary to understand KRAS biology and the role Lumacras can play in non-small cell lung cancer, colorectal cancer, and other solid tumors. We are delighted to announce that the global phase three code breaks 300 trial evaluating Lumacras combined with Vectavix in chemorefractory 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 designations in Lumacras in combination with Vectavix 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 code break 101 study. Beyond these data, we continue to explore novel combinations as we seek to move Lumacras into the first line setting. Recently presented data from the SCARLET study provide the rationale to initiate a phase three trial of Lumacras combined with chemotherapy in first line non-small cell lung cancer patients with PDL1 negative tumors. Phase 1B data in combination with Vectavix and chemotherapy support the initiation of a phase three study of Lumacras with Vectavix and full theory in first line G12C mutated colorectal cancer. In June, the FDA approved the supplemental biologics license application for BlinCIDO 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 BlinCIDO's accelerated approval to a full approval. Global regulatory submissions are on track for E1910, a phase three 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 BlinCIDO treatment added to consolidation chemotherapy over standard of care consolidation chemotherapy in newly diagnosed adult patients with Philadelphia negative ALL who are 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 BlinCIDO E1910 regimen as the only preferred regimen for the first line treatment of Philadelphia negative adult patients, adding BlinCIDO to multi-agent chemotherapy as consolidation in MRD negative disease, and lastly, moving BlinCIDO in combination with the tyrosine kinase inhibitor to the top of the treatment algorithm for MRD negative Philadelphia positive disease. Finally, in April, data were published in the New England Journal of Medicine demonstrating that BlinCIDO added to chemotherapy improved two-year survival in KMT2A rearranged BALL in infants compared to historical data. BlinCIDO two-year survival was 93% versus 66% for chemotherapy alone. If you look at the totality of the data, it is clear that BlinCIDO 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 BlinCIDO in earlier lines of treatment and improving patient convenience through subcutaneous administration. As the first bite, BlinCIDO also provides a roadmap for the development of molecules such as carlatamab, which could have an enhanced activity in settings of tumor burden. Two additional early oncology programs to watch are Zaluridamig and AMG193. Zaluridamig 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. Zaluridamig provides another example of a bispecific T cell engager demonstrating activity in a solid tumor setting. AMG193 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 AMG193, which requires the presence of MTA to effectively inhibit PRMT5. Alterations in this pathway occur in approximately 15% of solid tumors are often associated with a poor prognosis and historically have been very hard to draw. We are currently enrolling a phase 1b flash 2 study of AMG193 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 Zaluridamig and AMG193 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 outcome study of Opacorian, our potentially best in class LP little a targeting small interfering RNA molecule and atherosclerotic cardiovascular disease is enrolling well, as is a phase 2 study of Meridibart-Capraglutide, formerly known as AMG133, 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 Meridibart-Capraglutide 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 postmenopausal 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 postmenopausal 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 Tespire, 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 eminently. 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. Orocatin-Limab, a 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 ROCCAT phase 3 clinical development program. We are also planning to initiate a phase 2 study in moderate to severe uncontrolled asthma as we explore Orocatin-Limab in this additional indication. Rounding out the clinical summary, we've continued to execute both on time and on budget with our biosimilars portfolio, including the recent initiation of a pivotal study evaluating the pharmacokinetic similarity of ABP206 compared with Opdivo, one of six planned new biosimilars. In closing, I'd like to highlight a recently announced collaboration with T-Scan Therapeutics. This is a multi-year collaboration that will use T-Scan'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 -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 percent, increasing investment in research and development, and delivering 8 percent -over-year non-GAF 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 percent -over-year and represent the highest quarterly revenues in Amgen's history. Product sales increased 8 percent while total revenues increased 7 percent -over-year, excluding the negative impact of foreign exchange rates. Second quarter total non-GAF operating expenses increased 7 percent -over-year. We invested in and advanced our pipeline and accelerated growth across our priority marketed products while delivering a non-GAF operating margin as the percent of product sales of 52.6 percent, demonstrating expense discipline. Non-GAF R&D spends in the quarter increased 7 percent -over-year, reflecting growing investments in our pipeline, driven by higher spending on late-stage programs and marketed product support. Non-GAF cost of sales as the percent of product sales increased 2.4 percentage points on a -over-year basis to 17.1 percent, primarily driven by higher profit shares and a changes in product mix. Non-GAF S&A expenses in the second quarter decreased 6 percent -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-GAF other income and expenses were a net $307 million expense in the second quarter. This -over-year favorability was driven primarily by the change in Beijing accounting from equity methods to a -to-market investment, with the impact included only in our GAF results. As expected, our second quarter non-GAF tax rate increased 1.7 percentage points to 16.4 percent, 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 and El Paso Ramp, as well as support for our marketed products including Tavneos. Second, we continue investing in our business. Capital expenditures are at near-peace levels driven by simultaneous construction of our -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 percent 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-GAP operating margin of roughly 50 percent. 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 may be lower compared to the second quarter due to the impact of the Medicare doughnut 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-GAP earnings for 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-GAP 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-GAP EPS, we expect third quarter non-GAP 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 New Asta sales of approximately $800 million and full year combined Conjante and M-Bossy sales of approximately $900 million. We now expect other revenue for 2023 to be in the range of $1.1 to $1.3 billion versus our prior range of $1.2 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-GAP operating expense for 2023 to increase by closer to 3% versus last year compared to our estimate of a 1% increase with higher cost of sales from projected increase sales, additional investments driving our innovative pipeline and increased support for our growing priority marketed products including Repatha and Otesla. We continue to expect a full year 2023 operating margin as a percentage of product sales to be roughly 50%, although it will vary in each of the remaining two quarters. We continue to expect non-GAP cost sales as a percentage of product sales to be between 16% and 17%. We now expect our non-GAP 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-GAP SG&A spend to be slightly down year over year as a percentage of product sales. We now expect non-GAP other income and expenses to be in the range of 11 to 12 billion down from the prior guidance of 1.2 to 1.3 billion. For the full year, we anticipate a non-GAP tax rate of 17.5 to .5% down from prior guidance of 18.0 to 19.0%. We expect Q3's 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.

Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by one. Again, to ask a question, please press star one. 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. One concern is regarding the autoimmune phenomena, and I'm reading some literature and suggest that in 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 what do you mean by phenomena? Is it a concern at all? Thank you.

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 two 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 two program. These are things that we will follow. They are followed routinely for almost all cytokine inhibition programs, but to date, we have not had a 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 while 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.

Sure, Mike. We've answered two parts. Maybe I'll kick over to Murdo on 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 political 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?

Yeah. 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-cass 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 the PESA for the lower-cass 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 PESA'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 PESA is they also were able to replicate the low-cass population results in Optic-J, in their Optic-J trial, sorry, they're not the low-cass, 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 PESA, we also remain very excited about their other two large inline brands with Pristexa and obviously, a Plizna. So overall, we remain excited and confident that the two companies working together on this really strong portfolio will be a good pairing.

Thank you, Michael. Our next question comes from Salvin 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 two data for Tralatomab and 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 one 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 one results. Thank you.

Yes, Salvin, thanks for the question. Very, very excited about this 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 context in comparison to phase one, as noted, we substantially exceeded the 23% response rate that we reported in phase one. We are planning to present these data at a fall conference embargoed, of course, in terms of providing more specifics. But I can tell you that I 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, do you want to say anything about safety? Obviously, you're in bar. 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'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 from Oppenheimer. Please go ahead. Your line is open.

Oh, hey, congrats on the quarter and especially the Tarlatumab and Luma crass results. And happy birthday to Arvind. For Luma crass, absolutely. For the Luma crass phase three 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 Luma crass? Thank

you. Yeah. You know, in regards, you know, 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, you know, have discussions with the FDA and other regulatory authorities on these phase three data. And as those conversations unfold, I'll provide guidance about the potential regulatory pathway. And then as I mentioned, you know, based on the strength of these data and phase one D data in the first line setting using a Vectabix chemotherapy Luma crass combination, we are also advancing a phase three trial in first line disease. So I think it's 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 Arvin from us here at Piper as well. Just a question on Amjavita. So obviously the uptake in the U.S. has, you know, not been maybe what was originally contemplated, you know, 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 ABD has done, you know, to sort of blunt uptake, you know, biosimilars to date. You know, what, if anything, on their part has surprised you guys maybe the most in terms of what they've done and, you know, what's the plan for the future and maybe going forward.

Sure. Yeah. Tick tock on that, Murdo. Sure. Thank you for the question, Chris. We're obviously very early innings still in this biosimilar market with Amjavita. 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, you know, 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 and the product mix I don't think has settled out yet between those two SKUs. I would also say that we're still waiting to see what happens in the payer negotiation cycle going into 2024. As you've seen, many of the PBMs are on record of 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 AVI strategy, look, we compete against them in the innovative side and we now compete against them with our biosimilar and we know their practice as 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 a Devo. 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 Tangenti and Envasi in our previous launches. So going forward, the majority of our biosimilar growth will come from -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 Umar Rafet from Effercor 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 Arvin's birthday today. So congrats on all the data. My question is, three and a half months 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 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 Tepeza 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.

Yeah. What I can say, Umar, without getting into specifics on the number being under embargo, is that I'm very happy with the efficacy package, overall response rate, progression fee survival, duration of response, and overall survival. And we'll have a presentation of all of those data at an upcoming medical Congress. But to me, it's a very, very compelling efficacy package. Okay. And on Horizon, Umar, 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, Umar. Our next question comes from Yaron Werber from TD Cowan. Please go ahead. Your line is open.

Great. Thanks for taking the question. I have a question on the Tesla and sort of as relating to Enveral too. Specifically, Enveral sort of bouncing back, which is good to say, it looks like that's really a net benefit from the contracting that you've put in place, given them Javita and generic Humira. Well, Tesla though is facing Cetikta, 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. Enveral did have a strong quarter and benefiting from, quite frankly, the best access we've ever had on Enveral, where we're covered across all the major PBMs now. So we're seeing really nice new patient growth on Enveral. So more new patients coming on to treatment with Enveral. 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 Enveral. But overall, I think there were some concerns perhaps last quarter that the biosimilar activity in this category was somehow impacting Enveral. And I was pretty clear last quarter that that wasn't what we were seeing. And it's definitely now clear in the second quarter that biosimilar competition for Humira is not negatively impacting Enveral. So we see stability in Enveral going forward. For Otesla, we're actually seeing some strength in Otesla. 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 Otesla through the back end 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. 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 Otesla is really the ideal first systemic agent. We have great commercial coverage with Otesla with very little prior authorization requirement. We have no testing requirement for initiation. And the affordability and -of-pocket is very good. So Otesla is an attractive option for PBMs and payers to maintain on their formulares. 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 milder form of disease. And no one else is indicated for that mild population from a systemic perspective. So the thesis is good. Now, I think CITIC2 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 have switched to CITIC2. What we're seeing is that that has slowed. We're losing less

to

CITIC2 in our current mix of patients that we have on Otesla. And we think that 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 Otesla to CITIC2. 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 Otesla, we can further penetrate that population of patients. So going forward, we're feeling good about it.

Thank you, Yaron. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead. Your line is open.

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 you laid out, I just wanted to ask on your thoughts on the implication to potentially a negative outcome on the bio-pharma value creation ecosystem and essentially the ability for companies like Amgen 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, Greg, which is that 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 of a size that makes it difficult for them to capitalize on the full potential of their innovation, especially globally. And so, you know, 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, the demonstrated expertise we have in manufacturing, you know, 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, you know, 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, you know, 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 Seagerman 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 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.

Yeah. Thanks, Evan. You know, we're, so a couple of reasons to target steep one. Number one, it's almost universally expressed on advanced cancer cells. There is not extensive high level normal tissue expression. So, that allows you to generate the therapeutic window that we're always looking for with bi-specific T cell engagers. You know, 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 may be in part target related. So, you know, steep one is a relatively novel target. You know, we are in the clinic, I think, you know, 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 be presenting data this fall. And I'd urge you to put Zaluridomig under the radar screen and pay attention to those data. But, you know, 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 CasBio. You know, you have the upcoming COPD data in the first half of year. I was just curious to get your expectations here. What's the threshold to success, especially in light of the recent sort of very positive Boreus data? Thank you.

Yeah, I think, you know, in light of what we've seen in the field, you know, we would look to see something that is, you know, competitive with that, you know, just to level set everyone, you know, the rationale for this study is that, you know, the target of TEDSPIRE, 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, you know, we'll look at the totality of the data that we've recently published, give us benchmarks as to what we'll hope to see.

Thank you, Colin. Our next question comes from Dane Leon 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 the Tesla and the good strength that seems to be coming out of some of those 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 percent TRX share? And whether you think that share could go back in favor of O-Tesla 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 two of Teraloetomab, is there anything we need to be aware of that maybe the patient population in this phase two small cell lung cancer study was maybe less heavily pretreated as opposed to what was seen in the phase one study, which is sometimes the case? Thank you.

Why don't we take it in two parts?

Yeah,

Dane, I'll attempt to answer your O-Tesla 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 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 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. We have not factored that into our go-forward, but it could happen.

Regarding Tarlatomab, no substantive differences, very heavily pretreated population will provide details with that.

Thank you, Dane. Our next question comes from David Reisinger from LeeRank Partners. Please go ahead. The line is open.

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

Yeah, in terms of the oral obesity program, it's moving through its phase one, 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-increting 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. Thank you.

Julian, why don't we take one last question as we are over a lot of time.

Certainly, our final question will come from Robin Konoskis from Truist Securities.

Please allow me to call Teamab to make my life easier. Usually, the first innovators expand a market like small cell to be much bigger than what people think of today. Walk us through the cadence of these phase one trials, in particular, the checkpoint inhibitor combination trial. When can we see data from that? How do you even harpoon the competitive landscape and how you differentiate from them? Thanks so much.

Let me start with the latter. I'm extremely enthusiastic about this molecule. As always, I'll let others talk about their molecules. But this one is one that we're really putting muscle behind to 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 percent of them are small cell lung cancer, incomparable numbers in Western Europe, for example. That gives you a sense of the patient numbers. The clinical development program over time 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. 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 lincito, we can really affect the natural history of the disease. Recall that upon initial diagnosis, only 7 percent of patients with small cell lung cancer will be five years later. That's the opportunity to change that, I think, is in front of us now. Okay. Thank you for your question, Robin, and thank you all for joining. As Arvin said, we know we're a couple of minutes over a lot of 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, Arvin Sood will be transitioning his IR responsibility to our treasurer, Justin Claes. Arvin will remain a VP in finance and will help Justin transition seamlessly into this new role. While he's not leaving, this is nonetheless a big moment, and I wanted to acknowledge it because I know Arvin is something of a legend and a fixture in the investor relations world. On a personal note, I want to just add that I've worked with Arvin now for more than 20 years. We began working together even before we both joined Amgen. I want 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 treasure 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 Arvin 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.