Eli Lilly and Company (LLY)

“I think we are extremely well positioned here in terms of supply, so there will be no gating of launches.”

“We're on the precipice of beginning the Phase 3 program for Tersolisib, the PI3 kinase alpha-selective inhibitor, which will be initially combined with existing endocrine therapies.”

“We're working with imlunestrant, currently an approved product as Inluyro, with EMBER-4 slated to read out next year in the adjuvant trial that is a major moment for that medicine.”

“We have a chronic lower back pain study ongoing with retatrutide, which will read out sometime next year.”

“That expectation is embedded in our guidance, and we expect to more than offset that with volume growth.”

“The medical exception process is likely a short-term factor, and we expect price to trend down over time because of broader access.”

“When you look at growth in dollars, not percentage growth, we expect to continue to drive significant growth in the second half of the year as well.”

“We pursued a broad package of comorbidity data in both the initial package and now in subsequent data that will read out over the coming year.”

“When we look ahead, we have the approval in Mexico and Saudi, and those are the markets where we will launch next. Most launches will come in 2027.”

“So we're beginning to see an inflection point on Foundayo now, and with continued access growth and overall HCP adoption, we believe that we'll continue to see growth in Foundayo over the coming quarters.”

“Based on the positive Phase 3 results in children six months to 18 years old in the ADorable trial program, we submitted for a pediatric atopic dermatitis indication in the U.S., and plan to submit to other global regulators later this year.”

“With our partner, Almirall, we're exploring even less frequent dosing, once every 12 weeks. These data are expected in 2027.”

“We look forward to European approval in the coming months.”

“We look forward to working with regulators as they evaluate this important new medicine and plan to submit in the U.S. in Q1 2027 under the BLA pathway.”

“The first readout, in obstructive sleep apnea, will come later this year, and we have an additional five ongoing Phase 3 programs studying Foundayo.”

“With more than 40 markets currently under regulatory review, we expect a global rollout in all major markets in 2027.”

“We expect continued strong performance outside the U.S., but with market share leadership already established, market expansion will be key to driving sustainable growth.”

“We now expect non-GAAP earnings per share of $35.50 to $36.50, an increase of $2.78 per share at the midpoint of our range before updating our guidance for the $3.03 impact of Q2 acquired IPR&D charges.”

“Based on higher revenue, we now expect our non-GAAP performance margin to be between 49% and 50.5%, an increase of two percentage points at the low and high end of the performance margin range.”

“We now expect full-year revenue to be between $85 billion and $87 billion.”

“Foundayo is under regulatory review in over 40 additional countries, and we look forward to additional approvals later this year.”

“We completed the U.S. submission of Foundayo for type 2 diabetes and expect regulatory action later this year.”

“We expect to drive brand awareness and differentiation through full-scale consumer promotion, including direct-to-consumer TV advertising beginning in Q3.”

“We look forward to sharing top line results later this quarter.”

“We look forward to presenting detailed TRANSCEND T2D 1 results at the American Diabetes Association scientific sessions in June.”

“So expect launches as we exit this year into next year in quite scaled markets.”

“That will be a gradual path in '26 as it starts and then continued growth in '27.”

“We expect a continued strong year-on-year growth -- sequential growth driven by patient activation.”

“We expect continued strong performance outside the U.S. but with share of Michel leadership already established, increased patient activations will be key to drive sustainable growth.”

“We expect European launches to begin contributing to growth throughout 2026.”

“We look forward to welcoming the Cintessa team to Lilly later this year and continuing the development of these important molecules.”

“And we plan to submit the results of BRUIN CLL-322 to regulators later this year.”

“We plan to submit these data to regulators later this year for potential labels.”

“We're pleased that our once every 8 weeks maintenance regimen is currently under FDA review, and we expect regulatory action later this year.”

“We plan to complete the U.S. submission for type 2 diabetes in late Q2 and anticipate regulatory action before the end of this year.”

“we now expect non-GAAP earnings per share of $35.50 to $37, an increase of $2 to the top and bottom of the non-GAAP earnings per share.”

“We expect our non-GAAP performance margin to be between 47% and 48.5% driven by higher revenue.”

“we still expect price to be a headwind in the low to mid-teens for the full year.”

“We have increased the top and the bottom end of the revenue range by $2 billion and now expect full year revenue to be between $82 million and $85 billion.”

“While we are currently having positive conversations and positive feedback from employers around this new platform that will most likely have a gradual impact in the back half of '26 and most likely incremental opt-ins for '27”

“We're excited to launch orforglipron soon with the entry price being similar to oral semaglutide.”

“We continue the conversations around expanding access in those PBMs for obviously the introduction of orforglipron in Q2.”

“We look forward to launching this new Zepbound offering in the US within the next few weeks.”

“We anticipate new Medicare access to obesity medicines will become effective no later than July 1, 2026.”

“So I think overall, we are well positioned for continued growth for Mounjaro outside the US in 2026.”

“We anticipate having some of those decisions and increased coverage over time in the employer space as we head into the back end of this year and mostly into 2027.”

“There is a bolus of patients that we have nowadays in the Lilly Direct business that we believe are also Medicare patients. So expect that bolus, I think, is between 10-20% will actually move into the Medicare space.”

“When you look at 2026, I would just reflect back on 2025. We had major launches more or less in every quarter with the exception of Q4. So I would actually look for Q4 as a base for 2026 growth.”

“We're planning to submit the results of the Core TRIUMPH program in 2026 to support applications for overweight and obesity, obstructive sleep apnea, and osteoarthritis of the knee for retreutide.”

“We expect to read out six additional phase three trials for retreutide in 2026, including the remainder of the core registration package for both the TRIUMPH obesity program and the Transcend type two diabetes program.”

“We expect to share detailed results later this year.”

“The primary completion is projected for 2027; however, the study will read out when the target number of progression events are accrued.”

“We also expect to initiate new phase three programs for two other oncology small molecules.”

“Later this year, we expect results from an additional phase three pirtobrutinib trial, Bruin CLL322.”

“Marketing, selling, and administrative expenses are expected to grow as we invest to support new launches across therapeutic areas.”

“Consistent with our strategy to invest in innovation, we expect R&D expenses will scale up in 2026.”

“We expect gross margin will be relatively stable to slightly down compared to Q4 2025, as favorable product mix and increased productivity are offset by price and new facilities coming online.”

“Within revenue, we anticipate Eblis, Jayperca, Inlureo, Kisanlo, and Omvo will all contribute to growth, whereas late lifecycle products like Trulicity, Talsa, and Verzenio are expected to be flat or decline.”

“While we anticipate a reduction in Medicaid access in 2026 due to key states like California removing obesity coverage, we expect new states will add coverage for people with Medicaid in 2027.”

“We expect Orforglipron to launch for chronic weight management in the US during 2026 and to launch in most international markets during 2027.”

“We believe these price concessions will be more than offset by increased volume over time as we expand the number of people who can benefit from Lilly medicines.”

“Price is expected to be a drag on growth in the low to mid-teens.”

“We expect to deliver industry-leading volume growth driven by our key products, partially offset by lower realized prices.”

“This 8,000-patient trial is the largest oncology trial we've ever conducted, and it is on track to be fully enrolled by early 2026.”

“We look forward to sharing top line results from TRIUMPH-4 later this year.”

“We now await results from ACHIEVE-4, which will trigger submission of orforglipron for treatment of type 2 diabetes anticipated in the first half of 2026.”

“We plan to announce updates on our 2 remaining new U.S. manufacturing facilities in the coming months.”

“we now expect non-GAAP performance margin to be between 45% and 46% of revenue”

“we are increasing the midpoint of our revenue range by over $2 billion and now anticipate our full year revenue will be between $63 billion and $63.5 billion”

“we expect these data in combination with BRUIN CLL-314 to form the basis of regulatory submissions globally.”

“For the obesity indication specifically, we look forward to results from 3 additional Phase III studies in the second half of 2026.”

“we expect retatrutide can deliver deeper and more rapid weight loss than existing obesity medicines even more than tirzepatide.”

“We expect results from up to 6 Phase III studies by the end of 2026 to support the obesity and related complications program called TRIUMPH and the type 2 diabetes program called TRANSCEND.”

“These submissions are beginning imminently, and we anticipate launching orforglipron in the U.S. for treatment of obesity next year.”

“We have 7 more Phase III trials reading out in 2026 and 2027 and we'll likely need to see data from at least a few of these before we more fully understand the profile of this medicine across a wide range of patients.”

“So as we look ahead to ATTAIN-2, we expect similarly encouraging results.”

“Our outlook is that as evidence grows and we find new ways and also different plan designs are available to different employers that, that will continue.”

“But inside of the health care system, which is most of the business, we think that we'll expect single-digit erosion like we do other chronic medications in net pricing, while maintaining a value point on list that makes good sense.”

“We expect the modified dosing regimen to be part of the EU labeling at launch as well.”

“We look forward to approval and launch there later this year.”

“We look forward to the readout of BRUIN CLL-313, which assesses pirtobrutinib versus chemoimmunotherapy in treatment-naive CLL/SLL later this year.”

“We also announced plans to initiate a new Phase III trial in people with knee osteoarthritis pain in overweight or obesity starting later this year.”

“ATTAIN-1 and ATTAIN-2 will support global submissions for chronic weight management, which we expect in Q4.”

“We expect results from 4 additional orforglipron Phase III trials over the next 5 months, 3 trials in people with diabetes from our ACHIEVE program.”

“We plan to submit these data to global regulators by the end of this year.”

“We expect to produce at least 1.8x the number of salable incretin doses in the second half of 2025 compared to the second half of 2024.”

“We expect the 2025 impact of currently announced tariffs to be modest, and this has been factored into our 2025 guidance range.”

“We now anticipate our revenue will be between $60 billion and $62 billion.”

“We will continue to bring more capacity online in the second half of 2025 and expect our production capabilities to increase further.”

“As you've heard, we are reaffirming our guide for the full year that the midpoint continue to be in that 32% range for the year.”

“We expect some progress in Medicare as well during the second half of this year.”

“To your question about the price, yes, again, I mentioned last time and I'll reaffirm it now, again, that mid to high single digit price erosion, we've seen that in the first quarter, by the way, minus 6% in price.”

“We plan to continue with additional country throughout 2025.”

“We also expect readouts from additional global Phase 3 trials later this year, which we believe will be important to evaluate Jaypirca in earlier settings of CLL, including a head to head comparison with ibrutinib.”

“Based on these data, we plan to initiate a Phase 3 program later this year in atherosclerotic cardiovascular disease and we're excited about the potential to bring what could be the first ever oral small molecule approach for lowering lipoprotein (a) to patients.”

“Assuming success in these Phase 3 programs, we plan to submit orforglipron for obesity in Q4 later this year, followed by Type 2 diabetes in the first half of 2026.”

“However, we estimate that the announced tariff currently in effect will have a limited impact financially, which we have absorbed within our 2025 guide.”

“As a reminder, we recently initiated a limited Mounjaro launch in China with expectation to gradually increase commercial launch in the second half of 2025 as supply becomes available.”

“Upon completion of our manufacturing agenda, we'll be able to supply medicines for the U.S. market entirely from U.S. facilities, as well as increase the volume of medicines we export.”

“However, the expansion of tariffs in other geographies or increases in retaliatory tariffs would have a negative effect on Lilly and for our industry.”

“And although our clinicaltrials.gov list is the date in 2027, we believe it could be earlier than that, so we're looking forward to that.”

“We're supplying the U.S. market well right now, we'll need to do more, and I'm pretty confident in that.”

“We haven't been clear on exactly when we'll show that data, but this year is a safe assumption.”

“I think as Dan mentioned, the first complete package for submission in the U.S. will be obesity. But we expect diabetes to shortly follow and then these other indications that have been discussed today.”

“We do not plan for that with Orforglipron. So we will plan to launch or submit and have approvals and then launch in a full sense, including activities you're used to seeing for primary care products like sampling, co-pay, full formulary access and globalization of Orforglipron as rapidly as possible.”

“As Dave referred to earlier, in terms of set bound, we expect adherence to be long here based upon the firsthand experiences that consumers have.”

“We expect access to continue to improve in 2025 as well.”

“CMS confirmed recently that they will reimburse OSA if Plan D plans decides to lift it. And they have 180 days to make that decision from the FDA approval, and we're working with plans right now, and we anticipate to get some Medicare coverage by the second half of this year.”

“Lastly, we expect a number of important regulatory submissions in 2025, including Orforglipron for obesity, as I detailed, insulin efsitora alfa for type 2 diabetes, tirzepatide for cardiovascular outcomes and multiple potential data sets for Jaypirca.”

“Late this year, we expect to see the first data from our triple-acting incretin Retatrutide which combines GLP-1, GIP and glucagon.”

“These trials will form the basis of our first Orforglipron regulatory submissions, which will be for the treatment of obesity, and we expect to occur late in 2025.”

“We expect weight loss in people with diabetes to be significantly less than in people living with obesity who do not have diabetes.”

“Earnings per share or EPS is expected to be $22.50 and $24 on a non-GAAP basis.”

“We estimate our effective tax rate to be approximately 16%.”

“Other expenses is expected to be $600 million to $700 million, driven by interest expense.”

“Our facility in Concord is anticipated to begin shipping medicines this year, and we plan to make continued progress on expanding our manufacturing network.”

“In addition, we forecast overall net prices to decline by mid- to high single digits in percentage terms, including U.S. Part D changes.”

“We expect oncology, neuroscience and immunology to also grow revenue in 2025 as Ebglyss, Jaypirca, Omvoh and Kisunla launch upticks continue.”

“Given the uptake of newer incretins, we expect Trulicity volume to continue declining as fewer new patients are starting on Trulicity.”

“We expect modest initial Mounjaro sales in China due to supply limitations, a more meaningful contribution in the second half of 2025.”

“While the current primary completion is projected for 2027, the study will read out when the target number of progression events are accrued.”

“We anticipate ACHIEVE-1 will read out in Q2 this year, followed by up to 4 additional type 2 diabetes trials in the second half of 2025 and a potential submission for this indication in 2026.”

“We expect PIF when and if approved, to have a similar role as OSA, an access opportunity, particularly in Medicare and Medicaid.”

“That effect will continue for sure for getting into the fourth quarter of the year that is including as part of our guidance.”

“But on top of that, it also opens up the door for access in Medicare, and with the decision that CMS announced back in April this year, we are confident that we will gain access also for OSA in Medicare.”

“As we escalate supply in Q4, which, as I mentioned, we're going to beat the 50% growth number, you'll see us grow our demand stimulation as well.”

“So we remain very confident based upon the underlying trend in the marketplace today and also the growth of both Zepbound and Mounjaro in terms of TRx, NBRx, and TRx that we are after a good Q4.”

“And that we will submit for U.S. approval for tirzepatide in adults with obesity and heart failure with Preserved Ejection Fraction before the end of this year.”

“And what we need to have in mind is that we will continue to increase access. We will see launches outside of U.S. as well now with Zepbound being approved and also can impact the global net pricing dynamics moving forward.”

“Getting into Q4, we don't expect to see major dynamics on that.”

“So, I would expect that in the short term, we continue to see some operating margin expansion on this ratio. In long term, again, we will continue to expand and drive sustainable growth that will basically justify the investments that we do in SG&A and R&D.”

“And what we expect to see moving into 2025, going into your question is we do expect to ramp up our demand generation activities in SG&A that will pay down into 2025, as well as we will scale our R&D.”

“I don't expect that to change materially. Of course, with a new market entrant, the percentage of patients in the setting who get any CDK4/6 inhibitor as adjuvant therapy could go up and that would benefit us and I expect that there will be some patients for whom Kisqali is a more appropriate choice, but I don't expect it to be a significant shift in our overall market dynamics.”

“Maybe just say one comment from my side. When we talk about more so from the demand perspective, I think in the U.S. in particular, the proxy that we alluded to on the growth that we see across both and Mounjaro and Zepbound in TRx of that 25% sequential quarter-on-quarter is a good proxy to start basically trending out into next year, more so to provide more perspective from the market side and the demand side than the manufacturer.”

“And we continue to focus on both developing the self-pay, but also increasing access for both Type-2 diabetes and chronic weight management over time. And that will be gradual as we enter new markets.”

“So I think we have many reasons to be excited about the outlook for 2025, driven by improved access across the commercial America space as well as the investments we have done, we believe to be direct.”

“The approval of obstructive sleep apnea will help us with employer opt-in because we know that outcome studies are critical to convince employers.”

“I think we will have some new data in the first part of 2026 since both the employers are making those decisions effective one-one in the new year to come.”

“And I think that's really about Q4, but even more about Q1 of 2025 and continuing acceleration there.”

“And our estimate is that will continue or accelerate as we add U.S. stimulation to that demand, which, as Patrik said, we're going to begin doing here really mid-November in earnest.”

“Maybe just to add to that, OUS as well, we continue to advance or engage new countries that we are going to be launching Mounjaro as well that will drive that part of that growth acceleration in the fourth quarter.”

“In addition, we plan to continue to scale R&D and step-up our investment across manufacturing and commercial to support the successful launches of these medicines to help even more patients next year.”

“We expect these products, together with our already launched products will contribute to strong growth of the company in 2025.”

“Based on the results from this trial, we expect to submit an NDA to the FDA by year-end, and we look forward to sharing detailed results at an upcoming medical meeting.”

“We look forward to sharing the topline data readout for SURMOUNT-5 later this year.”

“We are pleased to share that we expect U.S. regulatory action for tirzepatide in adults with obesity and obstructive sleep apnea yet this year.”

“We plan to submit a supplemental DLA to the FDA in the coming weeks for this modified titration.”

“EPS is now expected to be in the range of $12.05 to $12.55 on a reported basis and $13.02 to $13.52 on a non-GAAP basis.”

“We have updated our estimated effective tax rate to be approximately 17%, driven by the impact of non-deductible IPR&D in Q3.”

“Other income and expense is now expected to be in the range of $425 million to $325 million of expense on a reported basis and is unchanged on a non-GAAP basis.”

“Our expected ratio of gross margin less OpEx divided by revenue remains unchanged on both a reported and a non-GAAP basis.”

“Lastly, we also expect new Mounjaro launches internationally to contribute to growing in Q4.”

“We continue to expect that we will exceed our goals to increase production of incretin saleable doses by at least 50% in the second half of 2024 compared to the second half of 2023.”

“The new midpoint range represents approximately 50% growth in Q4 2024 compared to the same quarter last year, demonstrating a continuation of revenue growth acceleration.”

“We are updating our revenue guidance range to $45.4 billion to $46 billion.”

“I think it's hard to know exactly where that will net out. It probably nets out sort of in the neutral range. I don't think it will end up being a headwind or a tailwind sort of in totality, but we have to see how that shakes out.”

“We achieved a number of supply-related milestones in Q2 and have increased confidence regarding our expectation that production of salable doses of incretin medicines in the second half of 2024 will be at least 1.5 times the salable doses taken half of 2023.”

“So, I think we'll continue to see because there's not an abundance of supply. It's more of a real-time fulfillment situation, patients going to pharmacy counters and being told to wait a few days while their orders filled.”

“Will do. Thanks, Kerry. I appreciate the question. Yes. I think as we said, like dance, as I said earlier, we do expect to end in that upper 30s range this year.”

“And you should also expect to see within that mix, stronger sales and marketing growth as we get to new launches in the second part of the year and the R&D continue to scale the growth from what we've seen thus far.”

“The near-term growth, I would expect predominantly coming from already launched markets of Mounjaro.”

“I also mentioned Concord is doing well against its time schedule, and we expect product out of that site end of this year, early next year.”

“For the second half of the year when you don't have the Mounjaro dynamic pricing in the second half will be similar to prior year pricing.”

“In terms of pricing, we see stable pricing sequentially across quarters in '24. So, nothing unusual, Q1 to Q2 and our guidance Q3 and Q4 continue stable sequential pricing.”

“That goes away in the second half of the year as the co-pay program moves out of the base period.”

“we look forward to putting our next candidate into the clinic in 2025 and sharing more about its profile later this year.”

“We plan to submit results to the FDA and other regulatory agencies starting later this year.”

“Earnings per share is now expected to be in the range of $15.10 to $15.60 on a reported basis $16.10 to $16.60 on a non-GAAP basis.”

“We have increased our estimated effective tax rate to be approximately 15%, driven by changes in our forecasted mix of earnings in higher tax jurisdictions.”

“For other income and expense, we now expect between $525 million and $425 million of expense on a reported basis, and between $400 million and $300 million of expense on a non-GAAP basis.”

“Given the update to revenue guidance, we now expect the ratio of gross margin less OpEx divided by revenue to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis.”

“In the second half of the year, we expect a more significant growth in Q4 compared to Q3.”

“Based on the midpoint of the range, our updated guidance implies revenue growth of 38% in the second half of the year, below 31% in the first half.”

“We are raising our full year revenue outlook by $3 billion to be between $45.4 million and $46.6 billion.”

“And in the U.S., we expect sales to accelerate as the product-specific code went live on July 1.”

“probably the most meaningful part of that will show up in the early '25 to be honest, as that new form ramps and details on that rollout will be coming in the coming weeks.”

“While supply and demand has come into better balance, we expect increase in demand may result in periodic supply tightness for certain presentations and dose levels.”

“we're also confident that with the new data that we presented just weeks ago in terms of obstructive sleep apnea, that's going to be reimbursed in Medicare Part D. And we expect similarly for other comorbidities and the readout of HFpEF, assuming that's positive and approved, and later on with the mobility-mortality outcome study.”

“We remain on track to meet expectations we set earlier this year, the production of saleable doses of incretin medicine in the second half of 2024 will be at least 1.5x the saleable doses in the second half of 2023.”

“Think about a construction of a site, for example, Concord in North Carolina, which we said will become operational by end of the year, and we'll start seeing products next year.”

“Now based upon what CMS stated early April, we actually expect to get obstructive sleep apnea for Zepbound covered by CMS and Medicare at the time of launch.”

“But from the second half of this year, we should expect to see typical pricing headwinds for Mounjaro as well.”

“We expect acceleration in revenue growth through the second half of the year as supply of incretin medicines continues to ramp.”

“We expect regulatory action in the second half of this year.”

“Along with the Nectin-4 ADC and PNT2001 start, we expect at least three other new molecules to enter the clinic this year.”

“We're encouraged by what we're seeing in our oncology portfolio and expect 2024 to be particularly productive.”

“We'll present detailed results of SURMOUNT-OSA during a symposium at ADA on June 21. Additionally, we plan to submit to the FDA and other global regulatory agencies beginning midyear.”

“While timing for launch will vary by country, we expect to start launching in the EU in coming weeks.”

“In the short to midterm, we expect sales growth to primarily be a function of the quantities we can produce and ship.”

“We're pleased with our Q1 results and the continued momentum in our business, which positions us well for accelerated growth as this year progresses.”

“Potentially next year, obviously, we'll see. We'll continue to invest and ramp as we go into next year, but it could be quite some time.”

“Again, that's in '25, so we can expect launch maybe a year after that, and that's an important event in the time course of the incretin class.”

“here, we do plan to build ahead of Phase III at risk.”

“And so we anticipate further growth, anticipated four launches of Mounjaro outside of the U.S. and continue with that throughout the year as well as into 2025.”

“We're looking forward to FDA action and the potential launch of Erenumab in Q1 of this year, and we are progressing with regulatory reviews around the world.”

“We also expect the full Phase III program readout on our weekly basal insulin, insulin efsitora alfa alpha later this year.”

“Through a combination of internal discovery efforts and business development, we expect to put at least five new molecules into the clinic this year, a wild-type of selective KRASG12D inhibitor, a pan-KRAS inhibitor, two antibody-drug conjugates with two biasomere's payloads, one against Nectin-4 and one against folate receptor alpha and an actinium PSMA radioligand therapy.”

“We expect R&D expense to increase at a higher rate than marketing, sell and administrative expenses.”

“We also expect R&D expenses in 2024 to increase, driven by growing investments across all phases of our pipeline as we invest for the future, with the majority of dollar growth driven by ongoing and new late-phase opportunities.”

“we expect marketing and administrative expenses to again grow in 2024 though at a slower pace than revenues, with growth driven by marketing investments in our recently launched and upcoming launch products.”

“While we are not providing a specific guidance number for gross margin as a percent of sales, our expectations remain consistent, but we will maintain gross margin of approximately 80% on a non-GAAP basis as productivity gains and volumes are offset by pricing pressures and the cost of new manufacturing facilities.”

“The lingering base period impact of the Mounjaro non-covered co-pay card dynamics will dampen these price declines in the first half of 2024, with more significant price declines expected in the second half of the year.”

“In terms of pricing for our core business, which excludes divestitures, we expect a high single-digit percent price decline in 2024.”

“In terms of phasing of our revenue growth throughout 2024, while we don't provide quarterly guidance, we expect revenue growth to accelerate in the second half of the year, consistent with the increased availability of Incretin doses.”

“Outside the U.S., we expect an acceleration of growth in every major geography led not only by the anticipated launches of Tirzepatide but also continued strong growth of Verzenio, Jardiance, and Taltz.”

“Jardiance has been another outstanding contributor to growth, and we expect revenue growth to continue in 2024 though at a slower price as strong growth may be dampened by pricing dynamics in the U.S.”

“Given the expected timing of FDA regulatory action, we expect Lebrikizumab to contribute only modestly to revenue growth in 2024.”

“With the current state of diagnostic and treatment readiness, initial uptake will be somewhat limited, and we expect Donanemab to contribute only modestly to growth in 2024 once approved.”

“We expect our production of sellable doses in the second half of 2024 will be at least one and a half times the production in the second half of 2023.”

“We expect our manufacturing site in Concord, North Carolina, will initiate production as early as the end of 2024, with product available to ship in 2025.”

“Given strong demand and time required to bring capacity fully online, we continue to expect demand to outpace supply in 2024.”

“we expect both Tirzepatide to contribute substantially to Lilly's revenue growth in 2024.”

“We are focused on building formulary access and employer opt-ins, but we expect that it will take some time before we reach broad open access in this market.”

“Should such a change take effect, our effective tax rate for 2024 would be moderately higher.”

“We think that there is a need to take up parenteral incretin supply pretty dramatically from the current levels. And we plan to do that.”

“With device assembly online at RTP, we are on track to achieve our goal of doubling capacity by the end of this year from where we were a year ago, and are gradually increasing production each quarter.”

“I think what you'll see is what you see normally for a product at this point in the lifecycle that as we pursue gaining access, there'll probably be some pricing pressure related to that. But we don't have any other coping card changes planned in the near future.”

“I think when you look at our access, and you look at our volume as we head into next year, you'll see a ramp up in volume as you see a ramp up in our access.”

“And so the overall growth in incretin will be mainly driven by as we are able to launch Mounjaro in new markets that's probably will go get the growth.”

“The multi use injector, which will come online sometime next year, and is a highly efficient play for us because it uses current systems and different ones from the auto injector.”

“We expect to have this test commercially available in a phased approach first, as a laboratory developed test by the end of this year.”

“Looking forward, we are expecting regulatory responses before the end of the year on our submissions for pirtobrutinib, and accelerated approval in CLL as well as tirzepatide for obesity.”

“I would note that we are trending towards the higher end of our estimates for gross margin and the top end of our ranges for operating expense categories.”

“The introduction of a single dose vial presentation in these geographies is intended to serve as a bridge to a multi-dose quick pen, which we expect will be available starting in 2024.”

“Looking forward to the end of the year with increased access we expect to continue to see overall growth in prescription trends.”

“We expect Mounjaro net price will continue to benefit from the higher percentage of paid prescription, but will also continue to face a headwind for more rebated volume as access improves.”

“We're also preparing for potential launch of tirzepatide for obesity in the U.S. this year.”

“It's important for people to know that the constraint we experience now is in the parenteral auto-injector space. So to the degree we move outside of that, using our multi-dose pen that's currently developed for insulin and we're redeveloping for tirzepatide or certainly the vial, which is quite accessible and high-volume systems available, we'll be able to make more than we had planned previously, just to be clear.”

“Based on these changes, we have raised our full year reported EPS guidance to now be in the range of $9.20 to $9.40 per share and raised our non-GAAP EPS guidance to be in the range of $9.70 to $9.90.”

“Our guidance for gross margin as a percent of revenue has increased to approximately 80% driven by the sales of rights for Baqsimi and our olanzapine portfolio.”

“Given the strong performance in our underlying business as well as revenue from the sales of rights for Baqsimi and olanzapine, we are increasing our 2023 revenue guidance by $2.2 billion to a range of $33.4 billion to $33.9 billion.”

“We've also said that once RTP comes online by the end of the year, we expect to double capacity from where we were last year.”

“In the short term, because we're seeing really unprecedented demand, we do still expect to see tight supply and some spot outages on Mounjaro through the end of the year.”

“Notwithstanding these long-term investments, we continue to expect our revenue will grow more rapidly than our expense base in the coming years and see significant opportunity for margin expansion.”

“In addition to last week's Retevmo announcement, we expect another 7 randomized trial readouts in 4 to 6 new first-in-human trials across small molecules and biologics in oncology over the next 12 months.”

“I'm pleased to share that we plan to advance retatrutide into Phase III for type 2 diabetes.”

“We initiated Phase III trials for orforglipron in both obesity and type 2 diabetes in the second quarter, and we look forward to those results in 2025.”

“We've also increased our estimated effective tax rate to be in the range of 14% to 15%, up from approximately 13%, reflecting the impact of the sales of rights for our olanzapine portfolio and Baqsimi.”

“OID is now expected to be between $0 million and $100 million in income, up from prior guidance of $100 million to $200 million in expense.”

“The range for research and development expenses has been increased to $8.9 billion to $9.1 billion, reflecting positive dynamics across our portfolio, including success in events in our early-stage assets, positive enrollment trends in our late-stage studies, broadening of the clinical program for next-generation incretin, and expected incremental expenses from business development activities.”

“Marketing, selling and administrative costs are now expected to be in the range of $7.2 billion to $7.4 billion with the increase driven by additional investments in recent launches in preparation for launches of new medicine and line extensions expected later this year.”

“Looking forward to the rest of the year, we expect continued growth in new-to-brand prescription as well as ongoing improvement in access.”

“As I mentioned in our Q1 earnings call, we expect Mounjaro access and saving cards dynamics to have an even greater effect on reported U.S. price changes in the second half of this year.”

“As base period headwinds from COVID-19 antibody revenue and Alimta's loss of exclusivity recede, we do expect strong growth to continue in the quarters ahead.”

“We talked last year that our focus was to double capacity by the end of this year, and we're progressing toward that goal.”

“Based on these changes, we are raising our full year reported EPS guidance to now be in the range of $8.18 to $8.38 per share and raising our non-GAAP EPS guidance to be in the range of $8.65 to $8.85.”

“This results in an updated R&D range of $8.3 billion to $8.5 billion.”

“This results in an updated range of $7 billion to $7.2 billion.”

“Our guidance for gross margin as a percent of revenue remains unchanged.”

“Starting with revenue, we are increasing the revenue guidance range by $900 million to now be in the range of $31.2 billion to $31.7 billion.”

“We do have Fast Track designation from the FDA to expect that -- to expedite it. We have a rolling submission. We already submitted the SURMOUNT-1 data. And we are excited to also talk about that. While we think the FDA will act quickly with the Fast Track designation, we want to remove any uncertainty. And so we will be using a PRV and expect that we'll get approval as early as the end of this year.”

“We believe that our channel inventory for Q2 will be a bit better for what we saw in Q1.”

“This early study informed the design of our CYCLONE 2 adaptive Phase II/III trial, which last year cleared our preset threshold to advance to Phase III and for which we expect to read out as soon as late this year.”

“Of course, we expect the next key milestone for genenumab will be later this quarter when we obtain the results for our confirmatory Phase III TRAILBLAZER ALS 2 trial.”

“We expect to have a European Commission decision in the first half of 2024.”

“We expect the next two studies, SURMOUNT-3 and SURMOUNT-4 to read out later this year, while SURMOUNT-5 is anticipated to complete in the first half of 2025.”

“In the coming quarters, we expect the impact of COVID-19 antibody revenue in the prior periods will ebb, while our new product and growth product categories of medicines will drive continued revenue growth and meaningful operating margin expansion.”

“As we move into the second half of 2023, we expect U.S. pricing headwind versus prior year will ease considerably driven by Mounjaro access and saving cards dynamics.”

“Rest assured, the line is going up into the right at a pretty steep angle in terms of our volume and output, and we expect that to continue for several years to come.”

“SURMOUNT-MMO, as an outcome study, will take several more years to complete.”

“We remain confident in the potential donanemab as a new treatment for people with early symptomatic Alzheimer's disease and look forward to sharing results from the Phase III TRABLASER-ALZ-2 study in Q2 of this year.”

“We maintain conviction that given the impact of this devastating disease and significant unmet need, positive confirmatory data and FDA traditional approval should be sufficient to support global reimbursement and patient access necessary for broad use of donanemab over time.”

“We've contemplated that into our guidance for 2023. And the overall impact is modest relative to historical declines in price in prior years. We expect that to continue to be in that mid-single-digit decline in price in Europe.”

“As we look at our capital investments in manufacturing sites this year alone, it's probably the largest we've ever had doubling what we had in 2022. We're looking at about $3.3 billion of investment just this year.”

“We believe that Mounjaro has a better profile. We invest a lot of innovation in there. And we do believe that it should have a better net price than Trulicity.”

“In immunology, we're looking forward to potential FDA approvals later this year for mirikizumab in ulcerative colitis, which we expect in the first half of the year and lebrikizumab in atopic dermatitis, which we expect in the second half of the year.”

“And for ganitumab, we're looking forward to our Phase III readout mid-year, which if positive will form the basis of our submission for traditional approval.”

“As we expand payer access, the proportion of paid scripts should continue to increase.”

“Revenue growth in Japan continues to be negatively impacted, albeit less so than in prior quarters by decreased demand for several products that have lost patent exclusivity including, the Alimta and Cymbalta. We expect to return to growth this year, as we scale key products and launch Mounjaro.”

“We have I would say a small or moderate impact on GLP sales or just probably lower rates of abandonment than what we'd see at higher out-of-pocket costs.”

“These data certainly reinforce our confidence in donanemab and the forthcoming readout from our Phase III TRAILBLAZER-ALZ 2 study, which is expected by the middle of 2023, and which, if positive, will form the basis of our application for traditional regulatory approval.”

“We've previously communicated that we expect to have internal Phase II data yet this year and use that data to make a decision whether this proceeds to Phase III or not.”

“That second facility will also come online beginning in '24 with some capacity and really '25 more fully.”

“But we are producing above our plans right now. We see that continuing.”

“So we expect over the upcoming quarters that net price will grow for Mounjaro.”

“We are also adjusting our bridging program to further ensure that it's utilized for people with type 2 diabetes, which will impact new start volume but should impact net revenue.”

“In the meantime, we continue working with the FDA to seek accelerated approval in early '23 and based on our TRAILBLAZER-ALZ data.”

“While these investments will slow our operating margin expansion in 2023, they are critical to maximizing pipeline and new launch opportunities to help sustain top-tier revenue growth and operating margin expansion over the mid- to long term.”

“Assuming inflation persist, we expect to see that impact in 2023 as well.”

“We continue to believe that COVID-19 antibodies will not be a major driver for long-term growth for Lilly.”

“In 2023, we will see the full year impact of the Alimta's patent expiry in the U.S., where new generics have eroded Alimta sales starting mid-Q2 and we anticipate a low single-digit headwind from foreign exchange rates.”

“While we anticipate that initial revenue from our next wave of potential launches will be modest in 2023 with only partial year revenue, we do expect the donanemab, pitubrutinib, mirikizumab and lebrikizumab will serve as additional catalysts for continued growth.”

“we have lowered our reported EPS guidance by $0.46 to now be in the range of $6.50 to $6.65 per share and lowered our 2022 non-GAAP EPS guidance by $0.20 to be in the range of $7.70 to $7.85.”

“If this provision is not deferred or repeal effective this year, then we would expect our reported and non-GAAP tax rate to be approximately 10% to 11%.”

“On a reported basis, other income and expense is now expected to be expensed in the range of $600 million to $700 million, reflecting the net impact of net losses on investments in equity securities during Q3 2022.”

“On a reported basis, operating margin is now expected to be approximately 26%, driven by the intangible asset impairment for our GBA1 Gene Therapy due to change in estimated launch timing.”

“Our non-GAAP operating margins remain unchanged at approximately 29%.”

“Our full year revenue outlook now includes an additional $300 million of headwinds from foreign exchange rates since our previous guidance update for a total impact of roughly $1 billion of foreign exchange headwinds of revenue for the full year compared to our original guidance.”

“To meet this rapidly growing demand across our incretin business, we have plans to add substantial additional manufacturing capacity.”

“We expect a return to growth in Japan beginning in 2023 as we continue to scale our key growth products and the impact of patent expiration subsides.”

“We are encouraged by the momentum of our business in Europe and expect continued growth as the impact from the patent expiry for Alimta, which lost exclusively in June 2021, received from base period comparison.”

“As we expect to maintain a high level of access for our innovative portfolio, we believe our volume should accelerate to drive net growth in the future.”

“We do not anticipate supply constraints for the U.S. launch of Mounjaro and we will monitor U.S. uptake to determine the appropriate timing for OUS launches.”

“I think net-net, I don't expect any step changes in GLP pricing as a result of Montero launching but it is part of the national pressure intention and contract negotiations.”

“On the cash pay side, we expect the percent of cash paid to follow our percent access in the marketplace.”

“Later this year, we'll begin surmount 5, a head-to-head study comparing weight reduction for tirzepatide versus semaglutide 2.4 milligrams.”

“We continue to look forward to the top line results of the Phase III confirmatory study, Trailblazer ALS 2 by mid-2023 which, if positive, will form the basis of our application for traditional regulatory approval.”

“Excluding the impact of acquired IP R&D and development milestone charges, we expect to see operating margin expansion from both revenue growth and driving further efficiencies in our business.”

“We expect to see this grow over time as we work to launch more innovative medicines like Manzaro.”

“We -- if this provision is not the further repealed effective this year, then we would expect a reported and non-GAAP tax rate to be approximately 10% to 11%.”

“Our outlook for gross margin, SG&A and research and development remains unchanged.”

“Our full year revenue outlook is unchanged.”

“For the full year, we continue to expect mid-single-digit net price decline in each of the U.S., EU and Japan and a double-digit price decline in China, resulting in a worldwide net price decline in the high single digits.”

“We expect improved access to continue to drive future volume growth more than offsetting the price decline over time.”

“We continue to expect a return to growth in Japan beginning in 2023.”

“We remain focused on gaining broad open access for Manzaro and expect the full impact of this medicine for patients and our business to be realized over time as that access is achieved.”

“We're encouraged that this potential new medicine could be available to patients in early 2023”

“So we do remain confident in donanemab and believe that TB-2 and our overall TRAILBLAZER program have extensive data and so as we review the requirements in the NCD, we believe our data should be sufficient to meet the high level of evidence criteria set forth by CMS if TB-2 as positive.”

“That’s what we are hoping for and that’s what we expect middle of next year.”

“We do expect that we show good outcomes there that for those people who have obesity and sleep apnea that we should be able to gain access for it.”

“We don’t anticipate an AdCom for tirzepatide.”

“We continue to see opportunity for meaningful operating margin expansion over time, excluding the impact of acquired IPR&D and development milestone charges.”

“We also expect to complete our initial submission in Q2.”

“We believe that given the thoughtful and robust design of TRAILBLAZER-ALZ 2, if the study is positive, it should meet the high level of evidence criteria set forth by CMS in the NCD decision.”

“We believe it would be beneficial for donanemab to obtain accelerated approval proximal to the TRAILBLAZER-ALZ 2 Phase III readout in mid 2023, which would enable parallel discussions with CMS regarding outright coverage and expedited review time for full FDA approval.”

“We are looking forward to further data from our maintenance studies in the first half of this year to provide insight into the durability of efficacy. Global submissions are expected by year end.”

“We are also excited to announce that we have submitted to the FDA and expect submissions in Europe and Japan in Q2.”

“We intend to start the other four Phase III trials later this year.”

“We are excited about the potential for this new indication and expect to share detailed results from the upcoming primary analysis at a medical meeting in the second half of this year.”

“We expect the remaining three global studies to read out in the middle of 2023.”