Amgen - Q1 2023

Transcript

Moderator (participant)

My name is Julianne, and I will be your conference facilitator today for Amgen's first quarter full year 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 one question during the Q&A session. To ask a question, please press star, then the number one on your telephone keypad. To withdraw your question, please press star one again. I would now like to introduce Arvind Sood, Vice President of Investor Relations. Mr. Sood, you may now begin.

Arvind Sood (VP of Investor Relations)

Thank you, Julianne. Good afternoon, everyone, welcome to our call to discuss our results for the first quarter of 2023. Strong unit volume growth that sets up the stage nicely for improved outlook for the balance of the year. These are some of the key themes that you are going to hear about today. 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 today, we'll make some forward-looking statements and use non-GAAP financial measures to describe our performance, just a reminder that actual results can vary materially. With that, I would like to turn the call over to Bob. Bob?

Bob Bradway (Chairman and CEO)

Okay, thank you, Arvind, and let me thank all of you for joining our call. I'll begin by calling your attention to the 14% volume growth we delivered in the first quarter that illustrates two points worth keeping in mind when thinking about the remainder of the year and beyond. First, on the COVID front, we seem to have finally turned the page on the pandemic in terms of its impact on the overall healthcare system. For example, we've seen year-over-year prescription growth across most specialties in the U.S., including cardiology and oncology.

That's good news because it suggests that patients are returning to their pre-pandemic routines with doctor visits once again enabling appropriate diagnoses and treatments. That's obviously something that bodes well for our portfolio of medicines. Second, we're seeing that the demand for medicines is resilient despite the current macroeconomic challenges.

Repatha, EVENITY, BLINCYTO, and KYPROLIS, for example, all delivered record sales in the quarter, driven by extremely strong growth in volumes of 33%, 55%, 49%, and 18%, respectively. We don't see this volume. Rather, we see this as the potential for these medicines and others in our portfolio to reach many more patients over time and contribute substantially to our long-term growth.

Take Repatha. We believe there's tremendous upside opportunity for Repatha at a time when most high-risk cardiovascular patients still never reach their recommended LDL levels or do so only for a brief, insufficient period of time. The global public health crisis in heart disease demands that all players in the system work together to drive change. With Repatha, we have a proven innovation that we know can be an essential part of the solution.

Two of our newest medicines, TEZSPIRE and TAVNEOS, achieved quarter-over-quarter volume growth in the U.S. of 28% and 27% respectively. TEZSPIRE has enjoyed strong adoption in the U.S. by both allergists and pulmonologists, a recently approved prefilled pen gives patients the option for self-administration.

A few quarters into our ownership of TAVNEOS, we're convinced that our deep experience in rheumatology and nephrology will enable us to bring this first-in-class medicine to many more patients who can benefit from it. Outside the U.S., volumes grew more than 20% in the quarter. In the Asia-Pacific region in particular, we generated nearly 50% volume growth as we expand the number of patients we serve in Japan and China, two of the world's most rapidly aging nations, with medicines like Repatha and Prolia. Amgen's R&D investment was up 12% in the quarter.

That growth reflects the investments we are making in registration-enabling trials for several potential new first-in-class medicines, including olpasiran in heart disease, rocatinlimab in inflammation, embamrotuzumab and tarlatamab in cancer. All four of these medicines are quintessentially Amgen. They're innovative molecules that deliver large effect sizes against serious diseases for which new treatments are very much needed.

We are pursuing a number of significant new indications for TEZSPIRE, BLINCYTO, and LUMAKRAS as well. We look forward to several data readouts from our pipeline, mainly in the second half of the year. We continue to invest heavily in early research, where we've built a differentiated set of capabilities over the past decade that position us well to take advantage of the rapid convergence of biology and technology that we see happening today.

At a time when the world marvels at ChatGPT, we've been deploying artificial intelligence and machine learning in our research labs for some time now, giving us dry lab capabilities that, when applied to biologics development, have already yielded improved success rates and reduced cycle times beyond our initial expectations. This is indeed an exciting time for biologic innovation. We remain optimistic about our announced acquisition of Horizon.

Similar to our experience with TAVNEOS, the more time we've spent with the team at Horizon, the more excited we've become about the potential to bring Amgen's capabilities and global presence to bear on Horizon's portfolio of first-in-class innovative medicines and its pipeline. It's an exciting time for all of us at Amgen. The demand for innovative medicines has proven to be resilient and growing around the world at the same time that our ability to innovate has never been greater. Always, I'm grateful to my Amgen colleagues around the world for their commitment to patients and to our business. Let me turn it over to Murdo.

Murdo Gordon (EVP of Global Commercial Operations)

Thanks, Bob. We kicked off 2023 with strong execution of our mission to bring innovative products to millions of patients globally. We saw record sales for 10 brands in the first quarter, with strong volume gains across our general medicine and hematology oncology growth brands, our inflammation therapeutic launch of AMJEVITA and the growth of TEZSPIRE and TAVNEOS. Our announced acquisition of Horizon Therapeutics will soon add several important medicines to our portfolio.

Volume growth in the first quarter was 14%, with 10% growth in the US and 22% growth outside the US. Asia Pacific continues to be our fastest-growing region, with 47% volume growth in the quarter. Excluding the impact of foreign exchange, first quarter global product sales grew 4%, including the 2% negative foreign exchange impact, product sales increased 2% year-over-year.

Starting with our general medicine business, which includes Repatha, Prolia, EVENITY and Aimovig. Overall revenue for these four products grew 13% year-over-year in the first quarter, driven by 19% volume growth. Cardiovascular disease is a growing crisis. In the U.S., someone has a heart attack every 40 seconds. for heart attack or stroke.

However, the state of care for high-risk ASCVD patients with elevated LDL cholesterol is shockingly poor. However, we have recently released from the FH Foundation of 38 million high-risk Americans, showing that fewer than 30% of them ever reached their recommended LDL levels. These statistics emphasize the importance of therapies like Repatha to address a significant medical need.

We're pleased that more and more patients are now benefiting from Repatha, and with volume growth of 33% in the first quarter, leading to an increase in sales of 18%, price erosion also slowed in the first quarter and declined less than prior year. In the U.S., volume growth of 32% was driven by broad adoption of Repatha by cardiologists and increasing adoption by primary care providers. Outside the U.S., we saw 34% volume growth with strong momentum across our international business.

There's clearly more work to be done to address this cardiovascular health crisis. This March, at the American College of Cardiology, we convened the first-ever annual LDL-C Action Summit to address the state of cardiovascular care in the U.S. by identifying strategies and delivering solutions to improve lipid management among the highest-risk ASCVD patients.

By intensifying the focus on lowering LDL-C, a coalition of leading stakeholders in cardiovascular care have come together with Amgen to unite on a bold goal. By 2030, our ambition is to halve the number of cardiovascular events in the U.S. We are confident that Repatha will play an important role in achieving this ambition.

Transitioning to bone health, Prolia sales grew 9% year-over-year for the first quarter, driven by 8% volume growth. EVENITY, which complements Prolia in our bone portfolio, had record sales at $254 million for the quarter, primarily driven by strong volume growth across markets. Now to our inflammation portfolio. Otezla volume increased 5% in the quarter. Sales decreased 13% year-over-year, driven by lower inventory levels and price declines resulting from patient and payer mix.

Additional rebates were also provided to improve the quality of coverage. Growth of our US 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 impacted by these programs throughout 2023. Longer term, we see strong growth potential for Otezla, given its established efficacy and safety profile, strong payer coverage with limited prior authorization requirements, and ease of administration.

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 naive US patients with milder psoriasis that cannot be optimally addressed by a topical and can benefit from a systemic treatment like Otezla. Enbrel volumes in the U.S. increased 1% in the quarter, supported by improved payer coverage.

Several important factors to consider when reflecting on Enbrel performance in the quarter. Global sales decreased 33% year-over-year, driven by declines in net selling price, lower inventory levels compared to previous years, and a 9% unfavorable impact of changes to estimated sales deductions related to prior periods.

Going forward, we expect low single-digit volume growth throughout 2023, lower year-over-year declines in net selling price, and a gradual recovery in inventory levels. The TEZSPIRE launch is progressing well with $96 million in sales in the first quarter, driven by strong adoption in the U.S. by allergists and pulmonologists. TEZSPIRE's unique differentiated profile offers broad potential to treat the 2.5 million patients worldwide with severe uncontrolled asthma without any phenotypic and biomarker limitations.

During the first quarter, the U.S. Food and Drug Administration approved TEZSPIRE for self-administration in a prefilled single-use pen, which offers patients the convenient option to administer TEZSPIRE at home. This improves accessibility and provides more flexibility in treatment options for all patients in the United States. Sales of TAVNEOS were $23 million in the first quarter. U.S. volumes grew 27% quarter-over-quarter, driven by an increase in new patients starting treatment.

In the U.S., TAVNEOS has now been prescribed to over 1,700 patients, confirming our belief that Amgen's deep experience in inflammation and nephrology and substantial market presence allows us to bring TAVNEOS to more patients with ANCA-associated vasculitis. In the first quarter, AMJEVITA launched as the first U.S. biosimilar to Humira, a medicine used by more than 1 million patients living with serious inflammatory diseases.

We saw the first prescriptions to patients being fulfilled this quarter, and we're encouraged by the high awareness of AMJEVITA among gastroenterologists and rheumatologists. With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to patients with this biosimilar medicine.

Looking ahead, we expect Q2 AMJEVITA sales in the US to be lower than Q1 sales as a majority of our US AMJEVITA sales in the first quarter stemmed from inventory build. Moving to our Hematology and Oncology business, which includes LUMAKRAS, KYPROLIS, Xgeva, Vectibix, Nplate, and BLINCYTO. Sales and volume for these six innovative products grew 21% year-over-year for the quarter, with KYPROLIS and BLINCYTO achieving record quarterly sales. Growth in our Hematology and Oncology business was supported by important new clinical data.

BLINCYTO sales grew 41% in the first quarter, supported by strong adoption across academic and community centers following positive data from the registration-enabling E1910 study presented in December 2022. Vectibix sales increased 16% year-over-year for the first quarter, driven by 15% volume growth, supported by positive data from the phase 3 PARADIGM trial, demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy.

KYPROLIS continued its strong trajectory with 25% growth in the quarter, driven by 18% volume growth. LUMAKRAS reported $74 million in sales in the first quarter and a 19% increase year-over-year, driven by 40% volume growth, partially offset by lower net selling price. Outside the U.S., LUMAKRAS has been approved in 50 countries, and we're actively launching in over 30 markets and pursuing reimbursement in the remaining countries.

Sales of our Oncology biosimilars declined 27% year-over-year in the first quarter, driven by lower net selling price. While our biosimilars for Mvasi and Kanjinti both hold leading shares in the U.S., we expect continued net selling price deterioration and accelerating volume declines driven by increased competition. Over time, we expect long-term growth in our biosimilars business to be driven by the addition of new molecules and additional launches.

Given the strong performance of our Hematology Oncology portfolio and the recent positive data on BLINCYTO and Vectibix, as well as ongoing clinical development of LUMAKRAS in our Oncology pipeline, I look forward to the future growth potential of this portfolio. As we close out this first quarter of 2023, I'm pleased with our strong execution across our portfolio, both in the U.S and internationally. With that, I'll turn it to Dave.

David Reese (EVP of Research and Development)

Thanks, Murdo, and good afternoon, everyone. For R&D, last quarter was one of high-quality execution as we progressed our innovative pipeline with multiple registration-enabling studies on track. In general medicine, we advanced our cardiovascular franchise and emerging portfolio of obesity molecules with a focus on clinical execution. Let's start with Olpasiran. phase three outcome study in atherosclerotic cardiovascular disease is enrolling well.

In March, we presented additional data demonstrating that Olpasiran markedly reduced Lp concentration irrespective of baseline levels in individuals with atherosclerotic cardiovascular disease and Lp levels greater than 150 nanomolars per liter. We also initiated the African American Heart Study in collaboration with the Association of Black Cardiologists and the Morehouse School of Medicine. This study will measure the association between Lp and atherosclerotic cardiovascular disease in 5,000 African American individuals.

African Americans show a higher average Lp(a) concentration than white individuals, but Lp(a) research to date has primarily been conducted in those of European descent. We are collaborating on the African American Heart Study to bridge this gap. Turning to obesity, we are rapidly enrolling a phase 2 study of AMG 133 in patients with obesity with or without diabetes and related comorbidities.

The study will investigate different dosing levels and regimens, with the overall goal of generating data that will provide broad optionality to design a phase 3 program that will deliver strong, sustainable weight loss. A phase 1 trial of AMG 786, a small molecule targeting non-incretin pathways in obesity, is enrolling patients. Multiple preclinical molecules, all with different mechanisms of action than GLP-1 or GIP-based therapies, are also advancing towards the clinic.

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 mid 2023.

The COPD trial is fully enrolled and has recruited a broad population of COPD patients, including patients with both high and low eosinophil counts. Emerging evidence suggests that TSLP is involved in chronic inflammatory disorders, including COPD, and that TSLP may be a key driver of the severe exacerbations experienced by COPD patients. We look forward to the readout of this study in the first half of 2024.

For rocatinlimab, potentially 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. This program is a suite of seven studies that will establish safety and efficacy in a broad population of patients with atopic dermatitis, including biologic naive, biologic or JAK-experienced, diverse ethnic groups, and adolescents, while also testing different dosing regimens, including the potential for monthly or less frequent dosing.

We were encouraged to see Horizon report on the statistically significant and clinically meaningful top-line results from a phase 4 clinical trial of TEPEZZA. As revised FDA label states, TEPEZZA is indicated for the treatment of thyroid eye disease regardless of clinical activity score or disease duration. Phase 2b studies in systemic lupus erythematosus of rozibafusp alfa and efavaleukin alfa were stopped for futility.

These studies utilize novel adaptive designs, which enabled us to generate decision-making data more quickly and cost effectively. SLE remains a challenging area for drug development, one that will be an area of focus for us as we further explore these datasets to advance our knowledge in the field. In addition to our organic pipeline, we look forward to incorporating the Horizon molecules upon deal close to further enhance our efforts to address inflammatory disease.

In oncology, global regulatory submissions are planned in the second half of 2023 for E1910, a phase 3 trial led by the ECOG-ACRIN Cancer Research Group, demonstrating that addition of BLINCYTO to standard of care consolidation chemotherapy significantly increased overall survival versus standard of care in MRD negative adult patients with newly diagnosed B-cell ALL.

Beyond this study, we are investing to move BLINCYTO into earlier lines of treatment and to improve patient convenience through subcutaneous administration. DeLLphi-304, a phase 3 study comparing tarlatamab, a BiTE molecule targeting DLL3 with standard of care chemotherapy in second line small cell lung cancer, will be initiated this month.

We'll have top-line data from a potentially registrational phase 2 study of tarlatamab in heavily pretreated patients with small cell lung cancer in the second half of 2023. Potential milestone for patients with small cell lung cancer. As you are aware, we are exploring novel combinations with LUMAKRAS. Phase 3 study of LUMAKRAS in combination with Vectibix in third line colorectal cancer is fully enrolled with data readout anticipated in the second half of 2023.

We plan to initiate a phase 3 study of LUMAKRAS and chemotherapy in first-line non-small cell lung cancer in PD-L1 negative patients. At ASCO, data will be presented from studies of LUMAKRAS in combination with standard of care chemotherapy in non-small cell lung cancer and in combination with Vectibix and standard of care chemotherapy in colorectal cancer.

We also completed submission of the LUMAKRAS CodeBreaK 200 data, along with data from the phase 2 dose comparison sub-study to the US FDA and to the European Medicines Agency, or EMA. For AMG 509, a STEAP1 targeting bispecific, now named xaluritamig, we have determined target doses and opened monotherapy expansion cohorts in patients with advanced prostate cancer. We look forward to sharing initial data in the second half of 2023.

To add to our growing biosimilars portfolio, we are pleased to announce that the European Commission granted marketing authorization for Bekemv, our biosimilar to Soliris. Bekemv is the first biosimilar to Soliris approved by the EC and is approved only for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria or PNH, a rare life-threatening bone marrow disorder. We have also submitted the U.S. biologic license application to the FDA for this product.

A phase 3 switching study to support an interchangeability designation in the U.S. using an investigational high concentration formulation of AMJEVITA met its primary endpoint of similarity for the primary pharmacokinetics endpoints. In conclusion, I would like to thank Amgen staff around the world for the relentless focus on execution as we work hard to meet the needs of the patients we serve. I'll now turn things over to Peter.

Peter Griffith (EVP and CFO)

Thank you, Dave. We're pleased with our execution and remain on track to deliver against our full year 2023 and longer-term objectives, driven again by strong 14% volume growth across a number of products, including Repatha, EVENITY, BLINCYTO, TEZSPIRE, and TAVNEOS. While we advance our late-stage pipeline and work to complete the acquisition of Horizon by the end of June, we continue to invest for long-term growth.

I'll review our first 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 first quarter financial results, which are shown on slide 38 of the slide deck, total revenue at $6.1 billion declined 2% year-over-year.

However, excluding the 2% negative impact of foreign currency exchange rates, product sales increased 4% and total revenues were unchanged versus the first quarter of 2022. The four percentage point difference was due to an expected decrease in other revenue due to lower profit and cost sharing from our COVID-19 collaboration with Lilly.

First quarter product sales are seasonally the lowest quarter as a percentage of the full year due to benefit plan changes, insurance reverifications, and increased co-pay expenses. In our first quarter, product sales increased 2% year-over-year, driven by 14% volume growth, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deduction, 2% lower inventory levels, and the 2% impact of FX rates previously mentioned.

First quarter total non-GAAP operating expenses increased 6% year-over-year, driven by investments in research and development. Non-GAAP R&D spend in the quarter increased 12% year-over-year, with higher spending in later-stage program support, discovery research and early pipeline, and marketed product support.

Non-GAAP cost of sales as a percent of product sales increased 0.8 percentage points on a year-over-year basis to 17.4%, primarily due to changes in product mix and higher profit share expense. Recall that cost of sales in the first quarter was impacted by a portion of the $125 million of Puerto Rico excise tax, the PRETA, that was previously capitalized to inventory, with the residual impact expected in the second quarter. Non-GAAP SG&A expenses in the first quarter increased 1% year-over-year.

We continue to focus on prioritizing key investments, digitalization, and driving productivity. Non-GAAP OI&E benefited from higher interest income and approximately $110 million of gains from deleveraging related to the repurchase of a portion of our debt portfolio. Also, recall we now mark to market our investment in BeiGene, with the impact included on our GAAP income statement. In the first quarter, this resulted in a GAAP-only pre-tax gain of about $1.9 billion.

As expected, our first quarter non-GAAP tax rate increased 3.7 percentage points to 17.8%, primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023, as well as increased interest expense on our existing tax reserves. We are committed to our capital allocation priorities.

First, we continue our investments in internal and external innovation that drive our long-term growth. Our increased spending non-GAAP R&D of 12% in Q1 2023 over Q1 2022, coupled with our acquisition of TAVNEOS and our announced acquisition of Horizon Therapeutics, will further broaden and strengthen our portfolio of first in class and best in class therapeutics to deliver to more patients globally. Second, we continue investing in our business to further long-term growth.

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 decline starting in 2024 with the completion and licensing of our Ohio plant. Third, we continue to return capital to our shareholders as we paid dividends of $2.13 per share in the first quarter.

This represented a 10% increase over that paid in each of 2022's four quarters. Free cash flow for the quarter was driven lower by the timing of sales, rebates and incentives, lower operating income, and higher CapEx from the building out of the state-of-the-art facilities in North Carolina and Ohio. We expect strong cash flow for the remainder of the year, consistent with our full year 2023 financial outlook that includes a non-GAAP operating margin of roughly 50%.

We expect sequential growth in our free cash flow in the second quarter, although there may be an impact to Q2 and free cash flow from the expected closing of the Horizon acquisition due to the accounting treatment of certain items that were all expected in our Horizon acquisition financing and estimated deal costs, as well as our previously announced restructuring in the first quarter.

Turning to the outlook for the business for 2023 on slide 40. Our guidance is currently provided on the Amgen standalone business and does not include any Horizon projections. We are raising our 2023 guidance. We're raising our 2023 revenue guidance to $26.2 billion-$27.3 billion. Versus previous guidance of $26.0 billion-$27.2 billion.

This reflects our confidence in the underlying business and the improving overall market conditions for our patients to access our medicines that Bob and Murdo mentioned. We are also raising our 2023 non-GAAP EPS guidance to $17.60-$18.70 versus previous guidance of $17.40-$18.60 per share. Let me mention a few more important considerations as you model the remainder of 2023.

For product sales, we project solid volume growth at a portfolio level and consistent with the first quarter. We expect a mid-single-digit price decline for our portfolio in 2023. We now project full year Neulasta sales of approximately $700 million and full year combined Kanjinti and Mvasi sales of approximately $850 million. We anticipate full-year non-GAAP operating expenses to increase by about 1% over last year.

We expect the 2023 operating margin as a percent of product sales to be roughly 50% and expect our second quarter operating margin to also be roughly 50%. We also expect cost of sales as a percentage of product sales to be between 16% and 17%. Non-GAAP R&D expenses in 2023 to remain unchanged and estimated to increase 3%-4% year-over-year.

Non-GAAP SG&A spend as a percentage of product sales to slightly decrease year-over-year, driven by our ongoing digitalization, continuous improvement, and productivity imperatives. We anticipate non-GAAP OI&E to be in the range of $1.2 billion-$1.3 billion, reflecting the first quarter deleveraging related to the debt repurchases I mentioned, with the remainder of the year's OI&E expense to be evenly split over the remaining three quarters.

We expect a non-GAAP tax rate of 18%-19%. We plan to continue to meaningfully increase our dividend. We continue to expect share repurchases not to exceed $500 million in 2023. Our capital expenditure guidance remains unchanged at approximately $925 million in 2023. Our confidence is strong in the long-term outlook for Amgen and our long-term growth. We look forward to completing the announced acquisition of Horizon.

We expect to provide updated guidance as appropriate after the transaction closes. Many thanks as always, to our 24,000 plus dedicated colleagues all over the world, executing each day on behalf of our patients and our future patients. That concludes the financial update. I'll turn it over to Bob for Q&A.

Bob Bradway (Chairman and CEO)

Thank you, Peter. Julianne, if you could remind our callers of the process for asking a question. I know they've had a long day already, ask them to hold their questions to one each and do our best to get to everybody who has one for us.

Moderator (participant)

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 Salveen Richter from Goldman Sachs. Please go ahead. Your line is open.

Salveen Richter (Managing Director and Lead Analyst, US Biotechnology)

Good afternoon. Thanks for taking my question. For TEZSPIRE, you've highlighted the broad clinical program. Given the phase 2 datasets we're expecting this year and next year, could you just comment on the indications where you have the most confidence in? Thank you.

Bob Bradway (Chairman and CEO)

Dave, over to you.

David Reese (EVP of Research and Development)

Yeah. Thanks, Saveen. You know, all of the indications that we're pursuing have some mechanistic basis. You know, chronic spontaneous urticaria, you know, is an eosinophil-driven disease in part, as is eosinophilic esophagitis, and given the mechanism of TSLP inhibition, that underlay the thinking behind pursuing those indications.

As I've mentioned briefly in COPD, as another example, the, there is accumulating evidence that triggers such as viral infections, smoke, particles from pollutants, can trigger TSLP release from bronchial epithelium. These are consistent with data showing that in patients with COPD, TSLP levels are elevated in sputum, bronchoalveolar lavage fluid, and bronchial mucosa. You know, as I mentioned, that trial is fully enrolled.

We expect a data readout, you know, given the duration of therapy, that one wants to see in these patients in the first half of next year. I think there's good mechanistic basis. You know, we're in clinical trial execution mode now, and really waiting data readouts.

Moderator (participant)

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

Michael Yee (Managing Director and Senior Biotechnology Analyst)

Thank you. Following on the pipeline, maybe for David. You know, I think what's interesting is that you obviously had AMG-133 obesity data, and now you are emphasizing AMG-786, and I think it's enrolling and treating people now. Can you just talk a little bit about why you'd be excited about that? Is that synergistic? Is there an angle with that to be excited about given all of the things going on in obesity? Thank you.

David Reese (EVP of Research and Development)

Yeah. I think what you said at the end there is very important, Mike, you know, in terms of everything that's going on in obesity. If we just step back for a second and think about, you know, what the magnitude of the problem is here. You know, there are hundreds of millions of patients now globally. We're doing an experiment in the twenty-first century that the world has never done by creating an obesity crisis. Now, we call obesity a single disease, but it is clearly a complex

Murdo Gordon (EVP of Global Commercial Operations)

Heterogeneous disorder. There are undoubtedly patient subsets buried within that, and different patients may well, you know, benefit from different therapies. This is, you know, a disorder that's rooted in human evolution and now is a function of our environment. Our development program for both 133 and for the molecules that will follow behind really intends to capitalize on the fact that there's a very large volume of patients.

It's a heterogeneous disorder. I think this is a field that is in its infancy and we have a chance to help define what those patient subsets are and who will benefit from specific therapies using, for example, you know, our industry-leading database of multi-omic profiling, which we, you know, intend to employ aggressively in these development programs.

You mentioned AMG 786, I'll just conclude with a comment on that. That is a non-incretin based mechanism of action. I think that is also an area that will be very fertile for drug development, and it's a focus of us pre-clinically as well right now. Thanks for the question. It's early days, but we think that this is one of the big public health challenges of the current century.

Moderator (participant)

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

Umer Raffat (Senior Managing Director, Large-Cap Therapeutics)

Hi, guys. Thanks for taking my question. I'm a little confused today about some of the numbers I'm looking at. For example, I mean, you know well AbbVie's Humira went biosimilar. You guys are the ones that launched it. AbbVie reported they're down 26% year-over-year. I guess what I don't understand is how come Enbrel is down 33% year-over-year, more so than the company that did go biosimilar.

I think some of that speaks to a little bit of the inventory issues that are happening, and they seem quite significant the more I think about the magnitude reported. For example, 21% drop on Enbrel and 28% drop on Otezla, which almost sounds like three weeks worth of work down. I usually think of total inventory in the channel being about three weeks, so would love to get any clarity there. Thank you.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah. Thanks, Umer. You're onto some of the fact pattern. Let me just go through kind of the elements of Enbrel specifically. First off, we were up 1% in volume in the quarter, the leading indicators of Enbrel volume performance all look quite good. That's a function of strong demand for the product in the market, good quality execution, and an additional pharmacy benefit formulary win starting in January of the year.

We would expect continued low single-digit volume growth throughout the course of 2023. That's the kind of high-quality leading indicators of the volume performance of the product. The inventory component is pretty substantial, as you highlight. It is a function of both wholesaler inventory levels being down as well as specialty pharmacy.

I think it's partly a function of the fact that we did have volume increase and there was also a pretty significant work down through the quarter. We would expect those inventory levels to return to normal inventory levels throughout the course of the year. Then the last piece of Enbrel is an out of period adjustment, an unfavorable adjustment of about 9% related to prior period. That's a function of things like state Medicaid true-ups coming in as well as some other price adjustments from prior period.

So overall, again, the leading indicators for Enbrel are good. Low single-digit volume anticipated for the year. A little bit of price concession to get that formulary win. The other two events in the quarter are likely to improve over the course of the year as well-being inventory and prior period adjustment.

Peter Griffith (EVP and CFO)

Maybe, Murdo, just to jump in quickly. That prior period adjustment, Umer, that's an estimated sales deduction adjustment.

Murdo Gordon (EVP of Global Commercial Operations)

Thank you, Peter.

Peter Griffith (EVP and CFO)

Yeah. Just to clarify that, and as Murdo said, we're looking for a slowing year-over-year price erosion on that too. We think we've got some trends in our favor here.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah, there is a big piece of that prior period that's also PHS. Given the program that we're running for PHS patients, we expect that to be a lower impact throughout the course of the year as well.

Moderator (participant)

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

Chris Raymond (Managing Director and Senior Research Analyst)

Hey, thanks. I have a question on the biosimilar business. I'm not sure I heard this correctly or not, but from Murdo's comments, it sounds like AMJEVITA revenue might be fairly front-loaded, given the inventory build that I think you guys described.

I know you guys don't give quarterly granularity, but maybe talk about the outlook for the rest of the year, especially given that you have a bunch of other launches, other biosimilar launches happening, you know, in that specific space. Then maybe just more strategically, just given the expectations have been kind of tempered here with AMJEVITA, you guys still seem pretty committed to this business with Soliris, EYLEA, Stelara launches. Just maybe talk about why these won't maybe see a similar tempering of expectations. Thanks.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah, thanks for the question, Chris. On AMJEVITA specifically, a lot of that Q1 revenue was what we would call buy-in from primarily IDNs, it's hard for us to see how much of that buy-in has been used up.In actual prescription fill. Our conservative estimate is that the majority of that is buy-in and that Q2 could be lower than Q1 revenues based on that.

That's our estimate for AMJEVITA. Obviously, we're very early in the launch year. We're building demand physician by physician and patient by patient. Some of that IDN pull-through is not visible to us because they don't share data necessarily with the IQVIA of the world. That's AMJEVITA. Overall, again, you know, we have been extremely successful in developing biosimilars at Amgen.

We are very pleased with what we've been able to do so far by developing successful molecules that are either first or first-wave launches. We continue to plan on being first or first wave in the biosimilar products that we're targeting. We have been able to continuously supply, thanks to the hard work of our manufacturing and supply chain colleagues around the world.

When we approach both institutional customers, payers and providers, I think there's a lot of trust in the Amgen brand when it comes to the biosimilars that we manufacture. Certainly last but not least, we do feel strongly that we will continue to be able to deliver on our 2x 2021 sales by the end of the decade in our biosimilars business, so more than double our 2021 revenues.

We think we'll do that by continuing to launch both pharmacy benefit and medical benefit biosimilars, but the majority of that growth is going to be driven by medical benefit biosimilar. Still a very important part of our business, and the people that work on it, continue to deliver value to the healthcare system, as we move forward.

Bob Bradway (Chairman and CEO)

The only thing I'd add to that, Chris, is that we're running this business very efficiently, and we think when we look at the cash that we're generating on this business, we're earning an attractive return for our shareholders. Again, in order for us to continue to succeed in biosimilars, we need to execute effectively. As you can see in the quarter with the Takembi progress and with the launch of AMJEVITA, we continue to do what we plan to do in biosimilars. Again, I would reiterate, we think we're earning an attractive return for our shareholders in those commitments.

Moderator (participant)

Thank you, Chris. Our next question comes from Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Mohit Bansal (Managing Director, Biopharma Equity Research)

Great. Thank you very much for taking my question. My question is also related to biosimilar. Given that the demand so far, doesn't look to be ticking up for Humira, and your comments about next quarter do not also suggest that it may be a slow launch here. Do you think this would mean that you are losing the first mover advantage here? Is there a way next year it could be more, AMJEVITA could be more on a preferred side of formulary rather than parity? It seems like parity is not cutting it just yet.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah. Thanks for the question, Mohit. I think we've definitely taken advantage of first mover, particularly with the IDN channel. That's really where a lot of the initial uptake will be. I think we're also differentiated versus the other biosimilar manufacturers that have biosimilars to Humira in that we do cover the customer base here quite effectively, both in rheumatology and gastroenterology, having deployed medical and sales teams that are out there right now, building awareness and demand for AMJEVITA.

Lastly, I would say that given that we've got parity access across the large three PBMs, we are in very good position to be able to pull through a lot of that AMJEVITA. I think we were clear in saying this would be a gradual uptake for this product, and we think that we still have been able to use the time that we have ahead of a competition wisely to build that demand.

Moderator (participant)

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

Jay Olson (Managing Director and Senior Analyst)

Oh, hey, thanks for taking the question. Curious about Otezla and how you expect the net pricing dynamics to evolve over the course of the year, especially in the context of Sotyktu being mostly free drugs right now, and how do you expect the pricing for Otezla to evolve following the transition of Sotyktu to paid customers? Thank you.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah. Thank you, Jay. I think what we're pleased with is the broad access coverage we have on Otezla. We have very good coverage. We did actually add additional coverage at the beginning of the year with UnitedHealthcare Optum Part D plan coming online. There's a little bit of price concession to do that in the year.

Beyond that, we've got good, stable access for 2023, and we look forward to being able to maintain that in 2024. I don't see a more decrement in price. In fact, we think price the negative price effects you saw in Q1 should abate a little bit in Q2 and beyond. Overall, very stable. The one thing that you mentioned that's interesting is the free goods program that competitors have out there.

I do think that that's a little bit of a disruption in the market right now that's probably causing a bit of softness in our new patient demand. We get about 80% of our new patient growth coming from systemic naive topical patients receiving Otezla as their first systemic agent. I think when you have free good programs in the market, sometimes that free goods is a very easy way for a prescriber to try a novel agent, and I think that that's taking away some of that new patient growth that we're used to seeing. I do think that that will be different once those competitors contract for their market access, and that's likely to be a 2024 impact.

Moderator (participant)

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

Colin Bristow (Managing Director and Private Wealth Advisor)

Hey, good afternoon, and congrats on the quarter. One for later on. We now got the chronic TEPEZZA data. I just wondered, could you give us your thoughts on this, and does this in any way change your view on the size of the commercial opportunity? Then a quick sort of housekeeping one on LUMAKRAS. How much of the weakness this quarter was sort of net pricing versus competition from Mirati? Thank you.

Murdo Gordon (EVP of Global Commercial Operations)

Thanks, Colin. Maybe I could take a minute just on Tepezza because there are quite a few analysts on the call that would be unfamiliar with how the patient journey for thyroid eye disease actually works. It's important 'cause it has a bearing on the demand pattern for Tepezza. The way in which the Horizon team actually track the performance is they look at something called patient enrollment forms, which is the initial request, if you will, to start a thyroid eye disease patient on Tepezza. It takes quite a while for that patient enrollment form to move its way through the prior authorization process against medical policies that payers have in place. That can take up to 90 days. You need to schedule that patient's first infusion.

In thyroid eye disease, it's not like in oncology where, you know, there's a clinical oncologist relatively evenly distributed throughout the country that can do infused drug administration. This is a lot more concentrated, it takes a while for the patient to be referred to the right site of care to receive their first infusion of TEPEZZA. That also adds time.

While tracking the early leading indicator that we look at, which is patient enrollment form, there's quite a lag between that patient enrollment form starting and when that first infusion will occur. That's really important to keep in mind when you see either flat or in this case, I think strengthening demand for TEPEZZA patient enrollment forms, that will take a while to pull through into net sales. That would be my prefacing comment.

Now, besides that, I think we're really excited, as Dave said, about, the chronic data that were recently announced. My congratulations to the entire Horizon team for executing a high quality trial and showing how TEPEZZA can benefit a broader cross-section of patients with lower clinical activity score and truly highlighting the need for chronic care in this category. I think that's a fantastic accomplishment. I think the simultaneous label change is just a nod to the conviction that even the regulator has about the utility of this product and this disease.

I think, you know, the Horizon team has spent a lot of time over the last few months expanding their commercial capabilities and their medical capabilities, and they're in really good shape to take this great new data, which is on label, to providers and to payers and to help expand the use of that product in the U.S. We're quite optimistic about the future growth of TEPEZZA. Of course, you know, from our side, we're also excited about being able to launch TEPEZZA in other markets around the world once we close this transaction.

We have the capabilities and the structure and the scale, given that we've been expanding Amgen's footprint globally over the last several years, and so we're ready to go, and we'll work closely with Horizon to do that so that TEPEZZA has multiple opportunities to grow over time. On LUMAKRAS, just real quick, we did see a little bit of increased inventory in the fourth quarter of last year.

The year-on-year compare or quarter-on-quarter compare, I should say, is really more about that inventory coming through. The actual demand is pretty flat from Q4 to Q1, and so we've been able to hold on quite nicely despite competitors in the market.

Moderator (participant)

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

Brendan Smith (Director and Senior Research Analyst)

Hi, guys. This is Brendan on for Yaron. Thanks very much for taking the questions. just another quick one follow up on TEZSPIRE, maybe specifically in CSU. can you give us a little bit of a sense of where you maybe see the bar for this mid-year readout here? Our, our understanding is that the mast cells are really one of the key players in CSU, and if TSLP is maybe a bit of a broader target, how do you see its impact on the disease course? Just trying to kind of understand relative positioning here and maybe gauge expectations for the phase 2 data. thank you very much.

Peter Griffith (EVP and CFO)

Yeah. Thanks. You know, look, the trial's, you know, fully enrolled. We're, you know, we're bringing in data. You know, I, you know, I think, you know, within a few months we're gonna have the dataset in hand. You know, I think I've, you know, outlined mechanistically why TSLP being upstream, could be, you know, one of the triggers that, if inhibited, could serve to, as a therapy for the disease. You know, at this point, you know, I think it's really just getting the dataset.

Moderator (participant)

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

Evan Seigerman (Managing Director, Head of Healthcare Research)

Hi, guys. Thank you so much for taking my questions. On OTEZLA, you know, we've noted over several quarters, you know, we know the demand kind of issues that are playing out. Anything you can do from a commercial perspective that could help accelerate growth even in light of the free drug programs we're seeing? Or do we really have to wait until that kind of tapers off come next year to maybe see some more growth from the brand? Thank you.

Bob Bradway (Chairman and CEO)

Yeah. Thanks, Evan. We're obviously doing quite a bit in the market from a commercial perspective. We've actually increased the breadth of our promotion to include much more primary care targets given that the milder patient who's on topical therapy today, that 1.5 million patient pool, it's a large addressable pool of patients, are currently under the care of primary care physicians and tend not to be referred as frequently to dermatologists as the moderate to severe patients.

We've increased our primary care footprint, and we're actually seeing growth in our primary care targets. Where we're seeing a little bit of pressure or a little bit of quarter-on-quarter pressure is in the higher end dermatology practices that treat more complex patients.

Murdo Gordon (EVP of Global Commercial Operations)

You know, that's kind of where you would expect to see some of the novel agents being tried. I do think that will stabilize over time, but that's gonna take most of the year to take place. We'll continue to expand our primary care presence, and we're also working to expand our direct-to-consumer efforts to a mild to moderate patient population that might be on a topical but still seeing unresolved symptoms due to their psoriasis, whether it be hands, face, scalp, or other areas where the patient really wants to resolve those symptoms.

Overall, there's quite a bit that we're putting into the market to increase our growth in that bio-naive or systemic-naive, milder patient.We would expect that that will strengthen our new patient capture, over the course of the year, and we expect to see good growth for Otezla for many years to come.

Moderator (participant)

Thank you, Evan. Our next question comes from Robyn Karnauskas from Truist Securities. Please go ahead. Your line is open.

Nicole Germino (Biotech Research Analyst)

Thanks for taking the question. This is Nicole on for Robyn. Can you help us think through the Neulasta franchise and how Amgen plans on maintaining share given that there are competitors with biosimilars, with auto-injector devices and other devices in the market? How much pressure should we see going forward? How should we think about the Neulasta franchise?

Murdo Gordon (EVP of Global Commercial Operations)

Thank you, Nicole, for the question. We're really pleased with what we've been able to do with the Neulasta franchise to date. We've been able to defend our volume successfully. Obviously, we've had to concede some price to do that, and the volume on the prefilled syringe side has been under some pressure. I'm very pleased with what we've done with the Neulasta Onpro device, and we've held on to substantial share there.

We think we've established good contractual commitments for this year. We'll continue to, you know, battle with competitors if they come to market with a different device than is currently available. We expect some continued pricing pressure there, as we've indicated. Overall, I think the team that's working on Neulasta has done very well.

Moderator (participant)

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

Gregory Renza (Managing Director and Senior Biotechnology Analyst)

Hey, guys. Congrats on the quarter, and thanks for taking my question. Bob, at the top of the call, you spoke about your R&D and identified, I think it was four medicines that you described as quintessentially Amgen. My question is for you and the team. As you look across your portfolio, but also externally in other areas, are there specific areas of opportunity that you think could benefit from the Amgen capabilities that perhaps are not represented or underrepresented in your portfolio today? Thanks so much.

Bob Bradway (Chairman and CEO)

Yeah. Dave and I can tackle that together. You know, I think we've been very clear about what we look for on the outside, which are molecules, that fit in our areas of strategic interest or where we think we have strength. And, in particular, you know, we're looking for opportunities in inflammation and in oncology and in general medicine, and we look for medicines that can be first in class, best in class, and have a big effect size in the patient populations that, again, where we think we can add value.

We're constantly looking. I don't think we feel like we're particularly, you know, exposed or that we need to emphasize business development in any one of those three particular areas, but we're always looking for attractive opportunities early and late. Dave?

David Reese (EVP of Research and Development)

Yeah. I would add the other component is technology platforms. You know, Bob mentioned briefly in his opening remarks, the use of artificial intelligence and machine learning. I think we've quietly become a leader in this area.

We are using artificial intelligence and machine learning across the R&D spectrum now, from molecular engineering, where we've been extraordinarily pleased with its the effect of dry labs or in silico design on the engineering of new protein molecules in time frames that are much, much shorter than were previously achievable with a higher success rate, success here being defined as a candidate going forward that has the molecular attributes that you want. We are using it extensively in the clinical trials arena, for site selection, for example, and other aspects of trial design.

This is something that I'll talk about more as we go through the course of the year, but these sorts of technology platforms, lead us to what I think is an absolute hinge moment in this industry, where the union of tech and biotech will move us forward to a qualitatively different time in drug discovery and drug development. And I think we're gonna be very well positioned to take advantage of this union.

Moderator (participant)

Thank you, Gregory. Our next question comes from Tim Anderson from Wolfe Research. Please go ahead. Your line is open.

Tim Anderson (Managing Director and Senior Equity Research Analyst)

Thank you very much. On Otezla, I'm wondering if you have any market share or performance metrics in the mild? ... psoriasis segment specifically, where you've had approval, for coming up on a year and a half. I'm guessing you have some idea of, the penetration you're making in that very different segment.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah. Tim, thanks for the question. Unfortunately, the differentiation between mild and moderate is difficult 'cause there isn't really good coding that we can use as a surrogate for determining which is which. What we look at is what percentage of our business is being sourced from systemic naive patients, which we infer that they are milder, and that the last treatment that they've been on prior to Otezla was a topical. 80% of our new patient growth right now is coming from the post-topical, pre-systemic patient type.

We are definitely making progress. What we're doing right now, as I mentioned earlier, is we're scaling our promotional effort that targets where these patients are being treated, and we expect to be able to grow the volume of patients that we're securing.You know, as you'll note, we grew the volume of Otezla in the quarter by 5%, and we expect to be able to improve on that.

Bob Bradway (Chairman and CEO)

Hey, Julianne, I know we're already at half past the hour, so, that's the time that we had asked, our colleagues to set aside for the call. We have a couple more questions in the queue. We'll try to get through those and then, as is our custom, be available if anybody has any questions for later this evening. Let's go to the next question.

Moderator (participant)

Certainly. Thank you, Tim. Our next question comes from Geoff Meacham from Bank of America. Please go ahead. Your line is open.

Geoff Meacham (Senior Equity Analyst)

Great. afternoon, guys. thanks for the questions. Murdo, of your new launch products in the past few years, you know, EVENITY stands out as one that had a really good progression each quarter. You know, what's the long-term opportunity here look like, and then how do you think about life cycle management of the bone franchise overall, you know, later on as you get closer to the LOE? Thank you.

Murdo Gordon (EVP of Global Commercial Operations)

Yeah. Thanks, Geoff, for the question and for noting the performance of EVENITY. The bone team have done an exceptional job with this product. I think, you know, the Amgen legacy in building the Prolia franchise is clearly helping. That along with our partnership with UCB. I was just recently in Japan, and, you know, as Bob mentioned in his opening remarks, we have an ultra-aging society there, and EVENITY is doing extremely well. I would say is a really good leading indicator of what we could do in the US with that product. I think we're really early in our ability to penetrate the millions of patients that would benefit from a bone builder like EVENITY.

We also see a very nice continuum of care for these patients, where, let's say, you're on a bisphosphonate or Prolia and you have a fracture. You go on EVENITY for 12 months, and then you return to a product like denosumab or Prolia for your continued care. There really is a nice franchise opportunity here with both Prolia and EVENITY. We see the addressable population as being extremely large, and we are still very early in growing that product. Obviously, now annualizing it over $1 billion is an exciting growth opportunity for us going forward, and we're as enthusiastic as we possibly could be.

Arvind Sood (VP of Investor Relations)

Julianne, let's take one last question after which Bob will make some closing comments.

Moderator (participant)

Certainly. Our next question comes from Dane Leone from Raymond James. Please go ahead. Your line is open.

Dane Leone (Managing Director and Senior Biotech Analyst)

Hi. Thank you. As we contemplate the updated guidance for the year, probably, two competitive questions are still curious to me on the call. Firstly, you've had great momentum with Repatha. Earlier in the week, Novartis really highlighted Leqvio or Inclisiran finally gaining some traction in the U.S. I'd love to hear your thoughts around how you view competitive dynamics in the PCSK9 class for the remainder of the year. Secondly, kind of on a similar note, I did notice LUMAKRAS declined Q-on-Q in the first quarter in the U.S. Was just curious if you saw any impact of KRAZATI, the competitive agent from Mirati. Thank you.

Murdo Gordon (EVP of Global Commercial Operations)

Thanks. Maybe I'll flip the answer around. We It's really too early to tell with Mirati impact. I think what I mentioned to, in response to an earlier question, the actual demand volume Q-on-Q is pretty flat. What we're actually seeing in the sales is a work down of some inventory, end user inventory from Q4 to Q1 of this year for LUMAKRAS.

Actual patients treated pretty flat quarter-over-quarter. We're not seeing a big impact yet from Mirati. Of course, for LUMAKRAS, we're really focused on growing LUMAKRAS through additional indications and additional data to move into earlier lines of therapy, which Dave covered in his remarks. As we look at Repatha, I think we really are excited about what we're seeing now.

We see more and more enthusiasm from cardiologists in a broad way and in a deep way, i.e., using Repatha more frequently in their prescribing practices for ASCVD patients. What we've been doing over the course of the last, let's call it 18 months, is increasing our Repatha commercial presence at primary care.

This year, we're actually making another step change in primary care promotional effort by increasing the size of our primary care sales force here. Repatha is very much moving in the right direction. Patients are benefiting from it. We maintain more than a 70% share of the PCSK9 class. Quite frankly, that's not what my team looks at.

They look at trying to penetrate the millions of ASCVD patients, the tens of millions of ASCVD patients that need to lower their LDL-C to below goal. As I mentioned in my opening remarks, less than 30% of patients, and that's not our data, that's data from the Family Heart Foundation, less than 30% of patients are at their LDL-C goal. We feel like this is important work. We feel like we've got best-in-class medicine in Repatha. We've got great coverage, and we expect to continue to grow this product globally to serve many millions of patients over the years to come.

Bob Bradway (Chairman and CEO)

Okay. Thank you, Murdo, for your, for your response to the question. Let me again thank all of you for joining us on the call. Just a couple quick thoughts. Obviously, we're off to a good start here in the year, as you can see from the results in the first quarter. As I said in my opening remarks, you know, far more important than the quarter itself is the way it's setting us up for the long term.

If you think back to the things that we've talked about as being important for us being able to deliver on our long-term growth strategy, you know, it starts with our growth products having to perform. As you saw in the quarter, we had 10 brands achieving record performance.

Performance means growing share, growing penetration, and as Murdo said, that's what we see happening now with our important growth-driving brand. The other thing we said is that for us to be successful over the long term, we've got to perform in the international markets. Again, I think the volume trends that you see here early in the year are a really good indicator that we're building the kinds of platforms we need to have in order to deliver long-term growth for our medicines outside the United States. We talked a lot about biosimilars on this call. We've said that we think is an important contributor to our growth long term as we bring new products to market and launch them in new countries.

In order for us to do that, we need to be a leading competitor, and that means we need to execute on time and be in the first wave of launches. Once again, this quarter, you see further proof points of our being able to do that consistently with the launch of AMJEVITA, the approval of Bekemv, et cetera. We think competitively, we're well positioned there in a biosimilar business to capitalize on the opportunities. Of course, pipeline is always critical and we're excited about how our pipeline is very rapidly advancing, particularly on the registration-enabling trials, whether you look at tarlatamab or bemarituzumab or rocatinlimab.

You know, we have a lot of important registration-enabling work underway, and we're excited to start generating results from that portfolio of products, as well as some of the products that are now attracting quite a bit of attention, like AMG 133 in our mid-stage pipeline. All in all, we're off to a good start in the quarter, and we remain very enthusiastic about the long term. In the meanwhile, we're looking forward to having an opportunity to close on the Horizon transaction once regulators have completed their work. Thank you for tuning in, and we'll look forward to being back with all of you in August.

Arvind Sood (VP of Investor Relations)

Great. Thanks, everybody. We'll be around for a while, so feel free to reach out to me if you have any questions. Thanks again.

Moderator (participant)

This concludes our first quarter full year 2023 financial results conference call. You may now disconnect.