One last remark. If you would like to follow the presented slides on your end as well, please feel free to go to roche.com/investors to download the presentation. At this time, it's my pleasure to introduce you to Severin Schwan, CEO, Roche Group. Mr. Schwan, the stage is yours.

Thank you. And also a warm welcome from my side. Welcome to our Q3 Sales Briefing. Let's get right into it. Here we go. As you have seen, group sales are up by 2% at constant exchange rates. I should say, in spite of the sharp decline we have seen with our COVID-related sales, both our COVID medicines, Ronapreve and Actemra on the Pharma side, as well as the decline on the Diagnostics side. All of that was only possible because of the strong growth of the underlying business of our newer medicines and the strong performance of the base business in Diagnostics. Both Bill and Thomas will comment on that in more detail in a moment. So if you look at the numbers again, we see stable business in Pharmaceuticals, with a 6% increase in Diagnostics, which results in the overall growth at the group level. On the slide, you can see the impact of COVID and the base effect versus last year. We had very strong COVID sales in Q3 last year, and the overall business has now decreased by 6% in the third quarter. Just to put it into perspective, in Pharma alone, we lost CHF 900 million versus the prior year, just in this quarter, due to Ronapreve and Actemra. Likewise, on the Diagnostics side, although to a lesser extent, we still observed declining sales, down by CHF 400 million versus the previous year. Now if we look forward to the fourth quarter, we actually expect that dynamic to change, particularly on the COVID side. The reason for this is that we have an outstanding order for Ronapreve in Japan in excess of CHF 1 billion. Combined with the continued strong growth of the underlying business, that gives us the confidence to confirm our outlook for the full year. If we turn to the next slide, you can again see the strong growth of the Diagnostics base business as well as the underlying Pharma business. You will see in more detail again the effect of COVID-related sales with Ronapreve and Actemra. We also had a negative impact from the entry of biosimilars in terms of Avastin, Herceptin, and MabThera of roughly CHF 1.5 billion. The guidance we gave you at the beginning of the year was that we expect a full-year effect of about CHF 2.5 billion. From where we stand today, just for Avastin, Herceptin, and MabThera, it will probably be a bit less, around CHF 2 billion for the full year. On the other hand, we have seen a more pronounced effect in the erosion of Lucentis and Esbriet, where generics have started entering the market. So overall, even though the composition is slightly different, the CHF 2.5 billion erosion still holds true. On the next slide, you can again see the underlying business if we correct for the COVID-related sales. Pharma in the third quarter saw only a 2% increase, while Diagnostics displayed robust sales with 7% growth, but the overall evolution including COVID remains negative. So looking a bit into the future for our product portfolio, we have a new record of new molecular entities in our clinical stage portfolio. We now have 85 new molecular entities, with 13 projects in Phase III and registration. You see a decline versus the half-year figures; that's entirely due to some of those medicines having been launched in the meantime, and a lot will come through in the next quarters. We have significant readouts in the fourth quarter, especially for gantenerumab in Alzheimer's. Additionally, there are also important readouts for Vabysmo in another indication, RVO, and I should also mention Venclexta in multiple myeloma. Into 2023, we have several important readouts, particularly in oncology, including many readouts with Tecentriq in the adjuvant setting. Regarding Alzheimer’s, we will present results for gantenerumab at the end of November at CTAD. I want to emphasize that we do not yet have any results in-house, so we have to wait for the results, which we expect in November, and we should be able to communicate more by then. I should also say that we received a breakthrough designation for our blood-based diagnostic test, which will be highly relevant not only for us but also for the entire field and for other potential medicines in this area. With this, I'd like to close. As you have seen, we confirmed the outlook for the full year with stable to low single-digit sales growth, and EPS expected to grow in the low to mid-single digits. On that basis, we should also be able to increase our dividend in Swiss francs again. With this, I'd like to hand over to Bill. Bill, over to you.

Thanks, Severin. Hi, everyone. Great to have the opportunity to share our latest results with you. It's been a very dynamic quarter, and I'm looking forward to more good things to come. This is the geographic picture to start with. Overall, in Pharma, we had stable sales year-over-year, year-to-date. This really reflects the competing forces, very strong delivery from our newer medicines, offset by declines in AH&R; and other medicines affected by loss of exclusivity, like Esbriet and Lucentis; and then also the decrease in COVID sales. This trend has been consistent across several regions, except Japan, which actually experienced a small increase in COVID sales, and that can be seen in the results. From the product view, again, the excellent performance from newer medicines is noteworthy. OCREVUS, HEMLIBRA, Evrysdi, Phesgo, Vabysmo, and Tecentriq all recorded strong sales across various regions globally. However, AH&R declines, along with significant reductions in COVID usage of Actemra and Ronapreve, coupled with the impacts of biosimilars and generics on Esbriet and Lucentis, are present. What provides us encouragement is the fact that the growth drivers are likely to remain in place while the items dragging down sales are on their way out. This situation bodes well for future quarters. Now regarding oncology, the overall sales year-to-date have seen only a 1% drop, which is quite remarkable, considering the drop in AH&R. Strong growth in the HER2 franchise—4% growth from Perjeta, Kadcyla, and Phesgo—is helping offset declines in Herceptin. The hematology franchise showcases various points of interest. Polivy is just starting to gain traction in the first-line setting in Europe, showing 79% year-over-year growth. A PDUFA date is set for April in the U.S. for Polivy, which gives us hope for further growth. Lunsumio is launching in the EU, with its PDUFA date at the end of the year in the U.S., and we expect additional gains from Lunsumio soon. Alecensa is still growing at 16%, maintaining its leadership and new patient share in major markets. Delving more into the HER2 franchise, Phesgo is seeing an impressive uptake, now at a CHF 900 million annual run rate. It's rapidly becoming the lead in many major markets. We have a Phase III study for Phesgo and giredestrant in first-line dual-positive MBC, along with others ongoing as well. Kadcyla similarly holds its ground in early cancer settings as well as first-line MBC, with several studies still underway. I would like to share some of the results from our studies presented at ESMO and ASCO that justify our confidence in giredestrant as a SERD. We believe it is a best-in-class molecule, showcasing strong performance when looking at patients with an ESR1 mutation in subsequent lines of treatment. The potential of giredestrant remains substantial. Looking ahead to Tecentriq, in Q3, we had 9% year-over-year growth. The U.S. continues to display solid growth across all regions, somewhat balanced out by a minor decline in Japan due to a price cut. While we've practically completed the price cut dynamics, we anticipate a return to growth for Tecentriq in Japan also. Furthermore, ongoing adjuvant studies for Tecentriq will continue to yield valuable insights, and we are optimistic about growth potential moving ahead. In hemophilia, HEMLIBRA enjoyed another fantastic quarter, showing consistent growth. Currently, 18,000 patients are being treated worldwide. We're collaborating with Chugai to develop a second-generation bispecific, NXT007, and we're looking forward to expanding HEMLIBRA to include mild-to-moderate patients in Europe, along with upcoming presentations at ASH in December regarding HAVEN 7, the infant study. Transitioning to immunology, the current quarter showed decreased sales for Actemra due to reduced COVID usage, and Esbriet has been adversely affected by generic competition, suffering a 48% decline in Q3, but Xolair and urticaria continue to show strong growth. Now looking at the multiple sclerosis (MS) franchise, we see a promising year for MS therapies, maintaining our U.S. market share at 35% for new-to-brand share while also seeing strong sales volume. The fenebrutinib Phase III program enrollments look promising, and we believe it will become an important asset for us in the future. Regarding the OCREVUS franchise, our program for a subcutaneous delivery method will allow for a more streamlined treatment process, reducing infusion times from hours to minutes. We're dedicated to making OCREVUS accessible for patients everywhere. In spinal muscular atrophy, Evrysdi had an excellent quarter, now treating over 7,000 patients globally and leading in all major markets. The Phase II JEWELFISH 2-year data showcased significant results for previously treated patients, suggesting promising developments ahead. In ophthalmology, Vabysmo has also performed well. After receiving our permanent J code, we expect to see not only broad coverage for Vabysmo but also strong uptake in the U.S. and abroad. However, regarding Susvimo, unfortunately, we must recall it voluntarily due to a manufacturing issue that affected the device's reliability. Although patients receiving refills will remain unaffected, we aim to rectify the situation promptly and ensure a better, more stable product for the future. Finally, I'm pleased to report that we have key late-stage news flow looking ahead. We're excited about the opportunities and advancements we have to share shortly.

Thank you very much, Bill, and good morning, good afternoon, everyone. With sales of more than CHF 13.8 billion, we are showing good growth of plus 6% year-to-date, driven by the base business across all customer areas, and I'll delve into details on the next slide. COVID-19 testing sales reached CHF 3.7 billion and are no longer a driving force in these numbers. Looking into the Core Lab, we saw 5% growth year-to-date, recovering extremely well in the third quarter, particularly following the impact of China lockdowns in Q2. Third-quarter growth for Core Lab reached 7%. When we exclude COVID-related sales, specifically the antibody sales, Core Lab grew at 9%, a strong result despite declines in custom biotech. The Point of Care category is showing robust growth at 30%, driven primarily by rapid antigen tests in the U.S. and APAC, alongside an 8% growth in the underlying aspects. However, Molecular showed a decline of 8%, largely due to less testing compared to last year. Excluding COVID-related sales, the base business there is still up 11%. In Diabetes Care, we registered a minus 3% decline; if we account for a one-time effect in Q1 2021, we would have been flat. Pathology is performing strongly, with growth in the double-digit range. Considering regionally, North America and APAC show strong growth in both COVID-19-related sales and base businesses. Still, the situation in EMEA and Latin America has been heavily influenced by fewer COVID-19 tests, although the base business in EMEA grew by 5%, with Latin America achieving a remarkable 15% growth in the base. Let's take a more in-depth look at the overall sales split. While total sales this year included CHF 3.7 billion in COVID-related revenue, the comparison of Q3 this year with Q3 of the previous year showed a decline of CHF 400 million. Ignoring COVID-related effects, the underlying business has grown more than 7%, an impressive performance. In Q2, we experienced 3% growth, heavily impacted by China lockdowns, but the sporadic lockdowns continue to exist in China, albeit on a lesser scale. As for our recent launches, we've delivered over 1.8 billion COVID-19 tests globally across more than 20 solutions with a focus on responsible pricing to enable access. We've placed over 2,000 units of the 6800/8800 and, with the update of the 5800 launch outside of the U.S. already, we have seen more than 250 placements as well. We're enthusiastic about launching an updated rapid antigen test—the sensitivity is significantly enhanced due to a new antibody. We also introduced a new antibody test with improved properties for detecting antibodies while also launching the interferon gamma release assay, which assesses T cell memory against the virus. Currently, we await FDA approval for the 510(k) submission for our SARS-CoV-2 test via the 6800/8800 systems, which would position us as a leader in such technology. Now regarding the Digital LightCycler, it represents the next generation in digital PCR systems, featuring three distinct plates for varying applications, promising superior performance compared to our competitors. The applications extend from cancer treatment monitoring to infectious disease tracking, including wastewater. We're also excited to incorporate a new immunohistochemistry assay for melanoma differentiation, which is crucial for accurately diagnosing melanoma. Early detection is paramount for survivability. As Severin highlighted, we've received the FDA breakthrough device designation for our amyloid plasma panel, reducing the number of patients needing confirmatory testing. This advancement will significantly alleviate the burden on PET scans and enhance treatment accessibility for individuals with Alzheimer’s. In conclusion, we are thrilled about our accomplishments this year and look forward to launching additional products in Q4 and exciting launches in 2023. With that, I'll hand over to Alan, who will guide us through the financial details.

Thank you, Thomas. I will be very brief today because we have a sales call. On the highlight side, there’s nothing major to mention. Looking at portfolio rejuvenation, which is ongoing, Severin described this in detail. It's evident in the Pharma underlying business. Notably, Esbriet has shown a reduction of roughly CHF 200 million, and Lucentis with roughly minus CHF 250 million, highlighting the underlying growth. The regional sales development in the Pharma Division reflects a fairly flat trend, with reductions noted in the U.S. and Europe, primarily driven by Actemra and Ronapreve. In contrast, Chugai exhibited robust growth, largely attributed to Ronapreve's performance. The momentum in the Diagnostics Division is powered by the underlying business as well as COVID sales with a 2% increase in constant rates. From a currency perspective, the impact remains modest, contributing only 1 percentage point, showcasing group growth in Swiss francs of plus 1%. The currency effect highlighted on the next slide indicates that while there's ongoing volatility, we anticipate a higher degree of robustness compared to the beginning of the year. Yet there will certainly be fluctuations in Q4. The currency projections are based on assumptions as of September 30, and thus, actual end-of-year results might vary. Moving to guidance: We confirm our outlook, which, in the current environment, reflects quite positively. The biosimilar impact for AH&R is projected to be around CHF 2 billion, somewhat improved compared to initial forecasts; nevertheless, it will be countered by losses from Esbriet and Lucentis, aligning with our CHF 2.5 billion estimation. Regarding COVID sales, while we initially projected CHF 7 billion in 2021 tapering to CHF 5 billion in 2022, it currently appears to hover around CHF 6 billion. We will await Q4 developments, but taking all factors into consideration, we uphold our guidance. Thank you, and I'm looking forward to your questions.

Thanks, Alan. We will now move into the Q&A session. We have about 50 minutes left, and we currently have 15 people in the queue. Our first question will come from Peter Welford, Jefferies. Peter, please.

Can you hear me now? Are we good? All right? So I have two questions. First, on gantenerumab, which I hope that you've already anticipated. Thanks for confirming that you don't have any data in-house at this moment. But I wonder if we could hear some thoughts from Severin and Bill regarding how your confidence has shifted following the lecanemab readout. Importantly, how are you thinking about the two studies at this time? You mentioned in the past that Roche would like to see two positive trials to move forward, but has your view changed, or indeed, has a decision with regulators changed? Also, if possible, an update on any prespecified pooled analysis that may be in consideration. Secondly, on Vabysmo, could you provide an update on the U.S. rollout? I believe 165,000 vials were slated for the U.K. Can you update us on that figure, the patient demographics for its use, and if there is any impact from the Lucentis biosimilars on adoption?

All right. Bill?

Yes. Thanks, Peter. Here's the breakdown. First, on gantenerumab, the impact of lecanemab on our perspective. Yes, I believe it's quite straightforward. Before the readout, there was ongoing debate about whether targeting A-Beta yields clinical changes in Alzheimer's. Post-data, this discussion should change significantly and gives us considerable reassurance regarding the efficacy of the pathway. Understandably, gantenerumab is different, with distinct affinities for various A Beta species alongside different dosing regimens. That said, we've put effort into delivering a regimen that effectively clears plaque, with hopeful outcomes soon. We have two substantial, well-controlled studies, both independently powered to show a 20% effect, along with a planned pooled analysis. Subsequently, we must wait for data, anticipating positive results across both studies. Regarding Vabysmo, indeed, our run rate has surpassed CHF 750 million worldwide as of September. We're observing switches from prior anti-VEGF therapies, alongside naive patients starting Vabysmo, which is promising information. The permanent J code in the U.S. should drive further uptake, although various factors, including contracts and market dynamics with Lucentis biosimilars, play a role in influencing growth. I hope that provides clarity, Peter.

Severin, do you want to add anything on gantenerumab?

No, I believe we're aligned here. We still await the in-house data. Thus, we stay eager and hopeful for November to reveal those results. Let's keep our fingers crossed.

Just picking up on the previous question. Severin, you clarified needing two positive trials, but Paulo initially mentioned that one positive trial along with a directional trend might suffice for filing. My assumption was always that, as a sponsor, you would aim to proceed with promising data given the unmet need, but correct me if I'm wrong. Additionally, regarding the FDA's response to the lecanemab data, do you—Roche—find incentives in pursuing accelerated approval for new CNS targets, including experimental surrogates?

Interesting. Thank you, Andrew, for your questions. As I address the first question, Bill, could you share your thoughts on accelerated approval evaluations in CNS?

Sure, Andrew. That's good insight. From my perspective, I see no large-scale changes. The FDA faced a decision with a drug backed by both positive and negative Phase III studies amidst compelling pharmacodynamic metrics. Under that situation, their priority to offer alternatives to patients was clear, resulting in accelerated approvals. While this may seem to shift the FDA's emphasis, I see no major inclination for nonclinical endpoints to act as bases for approval going forward. Likewise, meeting regulators' standards won't suffice if the physician's and payers' confidence will not align. Roche aspires to deliver high-impact medicines accepted by all stakeholders. Thus, any change perceived is likely not substantial.

I have a couple of inquiries on Lucentis in the U.S., as I'm trying to understand future biosimilar erosion in this category. How much of the Q3 decline in Lucentis was attributable to Vabysmo cannibalization versus biosimilar Lucentis impact? More broadly, how is the ophthalmology office space in the U.S. managed by payers? Are they influencing biosimilar use ahead of brands? In oncology, it's often a buy-and-bill model, indicating a less-structured approach; is it similar for ophthalmology?

Good question. We lack precise data on this due to the evolving nature of these developments. Competing factors do play a significant role, with biosimilar companies capable of providing discounts and financial incentives to physicians for switching therapies. Hence, it's not solely dependent on payers enforcing guidelines. I can't provide a detailed breakdown at this time. There are several intertwining factors causing both the biosimilar erosion and Vabysmo's market presence.

I have two queries, the first of which centers around gantenerumab. I understood there were discussions suggesting that there may be periods of knowledge about one study's findings, but not public communication. Is it reasonable to presume that both studies will be unblinded simultaneously? Secondly, regarding COVID orders for 2023, Severin, you've noted in your introductory comments the anticipation of significant government orders at the year's end. Are there ongoing discussions with governments or suppliers that can help shape expectations for next year?

Regarding gantenerumab, my understanding is that the data will all come simultaneously; there will not be a scenario where we have more insight than we can share. On the second inquiry, our planning—and we can’t accurately predict the future with COVID—primarily suggests low demand, yet we do have that substantial Japanese order for Ronapreve that will potentially reverse the trend we've witnessed in Q3. This is a one-off situation, but the assumptions for next year lean towards a lower demand as we transition to a kind of endemic phase.

Two inquiries, if I may. Regarding Vabysmo, could you provide clarity on the nature of the revenue figures from the third quarter—are they reflective of in-market sales, or is there inventory accumulation in those figures? For Tecentriq subcutaneous development, how should we conceptualize the target patient population regarding the broader spectrum of disease settings?

Sure thing! With respect to Vabysmo, the figures indicate that roughly 85-95% of the sales are switches, with about 70% being from aflibercept and 15-20% from Lucentis. Importantly, we perceive that the current revenue figures predominantly evidence market performance, as we've not noted any significant channel build-up since February. Now, regarding Tecentriq’s subcutaneous application, the design of the program while focusing on lung cancer establishes a likely precedent of applicability across multiple tumor types. We're hopeful about the future prospects of the subcu formulation as inquiry progresses.

I have a few more inquiries as we look towards 2023. Concerning Actemra, are we back to typical levels of use, or do you believe COVID stockpiling is still happening? What are your thoughts on potential biosimilar entry next year? For Kadcyla, given the competitive landscape, how do you interpret the outlook for next year? Lastly, regarding Diagnostics, Severin, I hear your comments on endemic levels; might we anticipate Q4 for Diagnostics reflecting such a level?

Thank you for your inquiries. Thomas, could you comment on the Diagnostics aspect, while Bill can address Actemra and Kadcyla?

As for our recent performance, we noticed that looking at Q3 metrics compared to Q4 does indeed hint at declining demand on the diagnostic side, particularly as we shift towards an endemic stage. However, given that it's still early October, we require more observation through the latter months of the year, particularly in November and December. For next year, our constant projection of COVID testing remains in the low to mid-single-digit billion category, possibly 20% taking that market share into account.

With regards to Actemra, we see some decline due to COVID treatment use, while also observing that conventional usage remains steady. Next year, we expect 2023 to be somewhat similar in terms of usage patterns to that of 2022, potentially with slight dips. As for Kadcyla, we’ve maintained double-digit growth year-to-date and anticipate further growth into next year.

Next question comes from Richard Parkes from Exane. Richard?

I have a couple of questions on gantenerumab. The CLARITY AD trials seemed to set a high benchmark for efficacy and the rates of ARIA. While we await efficacy data, I assume companies usually access blinded safety information; does this strengthen your confidence that the dosing schedule maintains lower ARIA rates? If so, can you confirm your anticipation that gantenerumab will have a competitive profile? Secondly, regarding Vabysmo, can you speak to the impact of the permanent J-code? Will it simply smooth reimbursement access, or does it pave the way for patient populations previously constrained from using the medicine?

Absolutely, Richard! Safety is paramount, especially in Alzheimer's treatment. The stringent criteria we’ve established during the gantenerumab regimen discussions are targeted at ensuring patient safety, emphasizing the need for an effective treatment with no adverse effects. Our aim is a minimized ARIA rate through our carefully calibrated dosing regimens. We await the data confidently. In terms of Vabysmo's J-code impact, I believe it could maybe help smaller practices that might experience more hurdles undertaking new drug protocols. In cases of established usage, top-tier patients have been prioritized; thus, determining if we see more treatment of naive patients as a result of the formal J-code would be promising.

I have a few quick questions: First, I appreciate clarity on gantenerumab's filing strategy, could you weigh in on the 27% benchmark from lecanemab as it relates to your outlook on the studies showing a 20% impact? If both studies yield a 20% effect, do you believe this permits a competitive asset, and how do you define clinical relevance? Also, regarding the next-gen bispecific in hemophilia, what insights can you share about the target profile and timelines?

Bill, can you address the gantenerumab aspect?

Certainly, Sachin. While we have our sights set on 20% efficacy, the data and how it presents will largely dictate its commercial outcome. Historical analogies suggest that even if we attain comparable efficacy levels, the means of administration, such as subcutaneous versus intravenous, will factor into competitive standing. As far as clinical relevance goes, our primary analysis revolves around CDR-SB and the numbers will naturally lead our judgments as more data emerges. Lastly, on NXT007, we have high ambitions but not yet established specifics; we believe any follow-up will exceed what HEMLIBRA can offer, further informing our direction.

Two questions from me: Firstly, on Vabysmo, it's intriguing that the number of patients on 16-week dosing appears to increase over time. Given the data observed, how do you perceive the future trajectory of this trend? Secondly, regarding Susvimo, can you shed light on your confidence in rectifying the septum issue and a projected timeline for such fixes?

Thanks, Wimal. It's challenging to speculate on how exactly Vabysmo's dosing will trend moving forward, but it's great to see the increasing uptick. Long-term data will help solidify the knowledge. Concerning Susvimo, we are committed to ensuring that we address the issues swiftly and thoroughly. So while we plan for a few months till we see improvements, we're also understanding that the timeline towards market return could potentially extend into a year.

I have inquiries regarding Tecentriq. Could you address concerns about pricing in Japan, particularly regarding the outlook in the U.S.? We noted a slowdown to 3% CER growth in Q3; can you help us gauge growth potential in that region over the coming years? Additionally, regarding TIGIT, I understand this quarter you upgraded SKYSCRAPER-06 to Phase III; could you clarify the basis for that decision?

Tecentriq in the U.S. was indeed affected by inventory shifts; we're undergoing a still-maturing adjuvant launch, capturing an expanding share. With four significant readouts on the way, we are keen on continued positive outcomes. For TIGIT, our upgrade to Phase III for SKY-06 was based on predefined protocols from the study, resulting from encouraging committee evaluations.

Can you confirm the timing of the gantenerumab data delivery; the company always indicated it would be available at some point in November. However, before you had indicated that a top-line release could be ready as early as October. Is it safe to say that the confirmed November press release is most likely now, and why was there a delay? Regarding the nature of the release, will it contain detailed results or merely directional statements?

Regarding gantenerumab, I can indeed clarify that we will have results to communicate in November but not sooner. In October, we were not prepared to announce specifics sooner than that timeline. The study is progressing per schedule, with the results set for contingencies of formal communication thereafter. As to the data type shared during the release, Bill, do you have additional insights?

Certainly, Stephen. We can gauge the data type as we get closer; clarity will accompany our release toward the CTAD date later in November. I assure you we won’t keep you waiting excessively.

Final question on the COVID situation—we’ve heard prior estimates for this year indicating a decrease in revenues, the aspects of biosimilars, and COVID evolving over the year. Are there viewpoints to shape expectations as we approach future forecasting, based on prior insights shared?

Ultimately, we are hedging down the demand projections for COVID and integrating insights alongside anticipated biosimilar impacts. Next year is too early to make a definitive case on this, but we’re prepared for a sharp drop nonetheless in COVID-related revenues. As we gear towards January and February, you'll gain more insight on a more specific forecast aligned with our strategic planning.