AstraZeneca Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
July 28, 2023

There are 28 speakers on the call.

Operator

Good morning to those joining from the UK and the U. S. Good afternoon to those in Central Europe, and good evening to those listening in Asia. Welcome, ladies and gentlemen, to AstraZeneca's Half Year and Q2 Results 2023 Webinar for Investors and Analysts. Before I hand over to AstraZeneca, I'd like to read the Safe Harbor statement.

Operator

The company intends to utilize the Safe Harbor provisions of the United States

Speaker 1

Private Securities Litigation Reform Act of

Operator

1995. Litigation Reform Act of 1995. Participants on this call may make forward looking statements with respect to the operations and financial performance of AstraZeneca. Although we believe our expectations are based on reasonable assumptions, By their very nature, forward looking statements involve risks and uncertainties and may be influenced by factors that could cause actual results Any forward looking statements made on this call Reflect the knowledge and information available at the time of this call. The company undertakes no obligation to update forward looking statements.

Operator

Please also carefully review the forward looking statements disclaimer in the slide deck that accompanies this presentation and webinar. And please remember to unmute your line when invited to speak. And with that, I'll now hand you over to the company.

Speaker 2

Thank you, operator, and welcome, everybody. I'm Andy Barnett, Head of Investor Relations at AstraZeneca, and I'm very pleased to welcome you to AstraZeneca's first half and Q2 of 2023 conference call. As usual, all materials presented are on our website. This slide contains our usual Safe Harbor statement. We will be making comments on our performance using constant exchange rates or CER, core financial numbers and other non GAAP measures.

Speaker 2

A non GAAP to GAAP reconciliation is contained within the results announcement. Numbers used are in 1,000,000 of U. S. Dollars unless otherwise stated. This slide shows our agenda for today's call.

Speaker 2

Following our prepared remarks, we will open the line for questions. We will try and address as many questions as we can during the allotted time. Although I'd ask participants to limit the number of questions you ask to allow others a fair chance to participate in the Q and A.

Speaker 3

With that, Pascal, I will hand the call over to you.

Speaker 4

Thank you. Hello, everyone, and welcome. Please Move on to the next slide. Total revenue in the first half of the year increased 4% to $22,300,000,000 With 16% growth in our non COVID medicines offsetting a $2,200,000,000 decline in our COVID-nineteen medicines revenue. Core earnings per share increased 21 percent to $4.04 This increase reflects both our robust business performance As well as a gain following an update to our contractual relationships for Befortus in the U.

Speaker 4

S. We continue to benefit from our diverse Commercial portfolio and our global footprint. Given our strong execution in the first half, we remain confident in our outlook for the remainder of the year, and we have Reiterated our 2023 guidance. Next slide, please. Taking a closer look at the performance of our non COVID business Across our regions and these areas, growth in the emerging markets continued to be strong, in particular outside of China.

Speaker 4

Emerging markets outside of China collectively grew by 38% in the first half. This growth underscores our confidence These markets will become increasingly important to our business. We also saw double digit growth across the EU and Europe in the period. On the right hand side, you will see that we delivered a robust double digit growth across oncology, CVRM, RNA and rare disease. And as expected, we saw declines in VNI.

Speaker 4

This growth reflects Strong Medicines performance across these areas. Please advance to the next slide. When we look at performance across our portfolio in the first half, we had 8 medicines deliver over $1,000,000,000 each in product sales. A broad range of these products are driving our growth, as you can see from this slide. Through effective life cycle management, we've seen an acceleration in the rate of growth Several medicines such as Imfinzi and Farxiga with new indications making important contributions to revenues.

Speaker 4

Ultomiris growth stood out once again and is the result of both successful conversion from Soliris as well as growth in patient numbers. We've also seen promising global growth from some of our more recently launched medicines, including HER2, Calquence, Breast 3, TESPYO and Saphnalo, All of which are helping to change the course of their respective diseases. Next slide, please. Confidence in our long term Look is supported by our robust late stage pipeline, which now has well over 120 active projects. Importantly, we maintain a rigorous to R and D development, setting a high bar for late stage trial initiations and advancing only the most promising projects.

Speaker 4

We strive to stay at the front of the innovation curve, and we have already progressed 14 unique new molecular entities into late stage development. We're making good progress towards initiating 30 new pivotal trials this year, having dosed 9 in the year to date, With recent additions including the LITHOS trial for breast treated asthma and 2 next generation propellant trials, Which will support expansion of our PMDI portfolio. As we indicated last quarter, most of the new pivotal trials are expected to dose in the second half of this year. Our pipeline continues to make exciting progress with 8 positive pivotal oncology trials already this year. These are shown on the right hand side of this slide.

Speaker 4

In particular, we are encouraged by the positive results from the TROPION LUNG1 Trial of Dettodexd and are excited to unlock the full potential of this promising medicine. On the next slide, Araduna can take you through our financial highlights in the first half as well as provide some further insights into how we are embracing the power of artificial intelligence Across our manufacturing and supply chain, over to you, Araduna.

Speaker 5

Thank you, Pascal, and good afternoon, everyone. As usual, I will start with our reported P and L. Please advance to the next slide. As As Kel mentioned, total revenue increased by 4% to $22,300,000,000 in the first half. Total revenue excluding COVID-nineteen medicines increased 16%.

Speaker 5

Alliance revenue of $627,000,000 Includes $475,000,000 of Anherto profit sharing from geographies where Daiichi Sankyo books product sales. Collaboration revenue of $220,000,000 includes a $180,000,000 license fee From the Serum Institute of India booked in the Q2 relating to our COVID-nineteen antibodies license agreement. Please advance to the next slide, which shows our core P and L. The core product sales gross margin in the first half was 82.9%, Benefiting from lower production costs in prior quarters and certain nonrecurring items in the Q1. As previously communicated, We expect the product sales gross margin in the second half to be negatively impacted similar to in prior years by seasonality for Flumus and certain other medicines, The mandatory price reduction for Tagrisso in Japan as well as the full impact of inflation.

Speaker 5

We still expect The product sales gross margin on a full year basis to be slightly higher than pre COVID-nineteen levels. Looking ahead beyond 2023, we expect product sales gross margin percentage will be negatively impacted by profit sharing arrangements. While we already see this dynamic with Lynparza, we anticipate the impact to increase as we start seeing higher Sales from medicines such as Inherto and Inspire in regions where we book product sales and then pay out a portion of profits to our partners through cost of sales. Over the long term, we're focusing on driving productivity improvements To counter the impact on our gross margins from inflation, continued growth in emerging markets and more complex and expensive Manufacturing of new modalities we are investing in. Core operating expenses in the half increased by 8%.

Speaker 5

R and D costs increased by 9%, driven by continued investments in our pipeline. The increase in SG and A costs partly reflect behind new launches such as Topaz and Himalaya, which are driving the strong growth of Imfinzi and Imjudo, for example, As well as existing brands like Forseigan, Breast Tree and geographic expansion of the rare disease medicines portfolio. We previously guided for total core operating expenses to increase by lowtomidsingledig percentage in 2023, And we now expect to finish the year towards the upper end of this range. Similar to the phasing we observed in 2022, We expect R and D and SG and A spend to be weighted towards the second half. Other operating income of $1,100,000,000 includes $712,000,000 related to the previously announced updated agreements on Bifortis, which was booked in the 2nd quarter.

Speaker 5

The increase in other operating income is in line with the guidance set out at the start of the year where we said that Other operating income will be higher versus last year. The tax rate in the second quarter was lower than our full year guidance Due to certain tax incentives and mix of profits and lower taxed legal entities, for the full year, we continue to expect The core tax rate will be between 8% 22%. Core EPS of $4.07 in the first half Represents an increase of 21% at constant exchange rates. Next slide, please. Our net cash inflow from operating activities increased by $400,000,000 to $4,900,000,000 And we continue to see improvement in our cash conversion.

Speaker 5

Net debt increased by $1,000,000,000 to $24,000,000,000 Driven by the payment of the 2nd interim dividend in March and $2,400,000,000 in deal payments, which include the second payment to Asserta made in the first As a reminder, we will pay the 3rd and final payment in 2024. For the full year, we continue to anticipate Deal payments related to prior business transactions to be in line with last year around €2,000,000,000 excluding Asserta. We have paid just under €1,000,000,000 in the first half. Our net debt to EBITDA ratio continues to decrease and is now at 1.9 times or 1.7 times if excluding The non cash adjustment for the Alexion inventory fair value uplift, which will soon disappear as we have now minimal Inventory remaining from the time of the acquisition. Today, we are reiterating our 2023 total revenue and core EPS guidance.

Speaker 5

Total revenues are expected to increase by lowtomidsingledigit percentage. Excluding COVID-nineteen, Total revenue are expected to increase by low double digit percentage. Growth in the second half will be hampered by Patent expiries, including Symbicort in the U. S. And Nexium in Japan, where we saw first generics end of last year.

Speaker 5

We now anticipate revenue in China to increase by lowtomidsingledigit percentage. And as I mentioned earlier, We now anticipate total operating expenses on the upper end of the range with phasing of SG and A cost towards the second half of the year similar to prior years. In addition, given that we anticipate starting several new Phase III trials in the second half of the year, R and D and associated clinical and new product Costs will be higher in the second half. Based on June average FX rates, we now anticipate a a low single digit adverse FX impact on total revenue and a lowtomidsingledigit adverse impact on core EPS. Please advance to the next slide.

Speaker 5

Continuing with the artificial intelligence theme, today, I want to highlight global operations And how we are leveraging AI to accelerate drug development, manufacturing processes and drive supply chain efficiencies. To share 3 specific examples here. 1st, in drug development, with our in house AI enabled tool, Route Manager, we have reduced in route synthesis lead times from 9 to 12 months to 5 to 6 months, and we're striving to further reduce lead times to less Additionally, with this tool, we've been able to reduce the number of experimental trials, cutting lead times and driving efficiencies in cars, while Also providing sustainability benefits through fewer synthetic steps. Next, with AI powered visualization of data, Our operators are able to improve process performance for synthetic and biologic medicine by identifying critical variables That will affect yield and make real time optimization adjustments. In the future, advanced continuous process verification We'll drive further robustness and yield increases.

Speaker 5

3rd example, we've implemented AI enabled enhancements across our supply chain. For example, Sweden is one of our largest global sites, manufacturing over 12,000,000,000 tablet and capsules every year. Here, we use AI powered digital twins that can leverage multiple data sources simultaneously, such as production orders, dispensing stations And cleaning status to optimize production schedules. This technology has already delivered a 90% improvement in scheduling time, Meaning, we can now develop a dispensing plan in only 4 to 5 minutes where it used to take 8 hours. Our ambition is to leverage many of these tools And rolled in throughout our manufacturing and supply network.

Speaker 5

This is, of course, a journey, but the work is already underway to use technology to drive efficiencies. While our operations team continues to deliver on seamless supply and new product launch delivery. With that, Please advance to the next slide and I will hand over to Dave to walk through our oncology business performance.

Speaker 6

Thank you, Aradhana. Next slide, please. We're pleased to report our Oncology medicines delivered total revenues in the first half of $8,800,000,000 An increase of 22% versus the prior year. We delivered double digit product sales growth across all regions. Turning to individual medicine performance in the Q2.

Speaker 6

Tagrisso Global revenues grew 10%, reflecting strong underlying demand For Adora and Flora across all regions. As expected, affected this June, we realized a mandatory price reduction in Japan. And in China, 2nd quarter revenues reflect the 1st full quarter of NRDL renewal pricing following reenlistment this March. Following the ASCO plenary presentation of ADAURA overall survival data last month, we expect expanded use of Tagrisso in the adjuvant setting as well as potential for new reimbursements in certain geographies. Lastly, as we consider the future impact from IRA, our Current interpretation of CMS final guidance supports the potential exclusion for Tagrisso under orphan drug protections.

Speaker 6

Lynparza remains the leading PARP inhibitor globally and delivered 2nd quarter product sales growth of 9%. In the U. S, we saw Sequential demand declined across the PARP inhibitor class following competitor label restrictions in second line ovarian cancer. We continue to work on opportunities for U. S.

Speaker 6

Demand expansion in ovarian and HR positive breast cancer, but still expect this to be more challenging. Outside of the U. S, we saw double digit product sales growth across the EU, established rest of world and emerging markets. In Q2, Imfinzi total revenues inclusive of Imjudo surpassed $1,000,000,000 in a quarter for the first time, Up 58% and largely driven by new launches of Topaz, Himalaya and Poseidon. I'll touch on Pacific Infinci growth drivers a bit later, but needless to say, we're excited by what the team has accomplished within a competitive IO class.

Speaker 6

Calquence total revenues increased 34% year on year supported by ex U. S. Demand growth, particularly in Europe. And in the U. S, Calquence continues to maintain leadership in frontline CLL with the majority of new patient starts in this setting.

Speaker 6

However, we continue to see some new patient share loss in the relapsedrefractory setting. In HER2, total revenues of $322,000,000 in the 2nd quarter increased 176% year on year. In the U. S. And HER2, new patient share in the HER2 positive metastatic breast cancer setting remains at 50% And in the hormone receptor positive HER2 low postchemo metastatic breast cancer share is now grown to above 50%.

Speaker 6

Importantly, we're seeing strong continued demand across the globe, particularly in European markets. Following the exciting approval for Destiny Quarter, we received approval for HER2 in HER2 low metastatic breast cancer. Also during the period, we received approval for PROPEL in the U. S. And anticipate a potential regulatory milestone to be paid in the second half of the year.

Speaker 6

And finally, we were granted priority review in the U. S. For Capitello-two ninety one. Next slide please. We've seen remarkable Imfinzi and Imjudo growth Driven by the recent launches of Topaz, Himalaya and Poseidon, we're excited about the current trajectory of these launches and the broader potential of Imfinzi As supported by the suite of ongoing life cycle management programs.

Speaker 6

First, Himalaya in unresectable hepatocellular carcinoma Has established a clear foothold for Imfinzi and GI cancers. Last month at ESMO World GI, we presented unprecedented 4 year overall survival data, The longest follow-up to date in unresectable HCC. This sustained benefit coupled with strong safety We'll continue to support rapid adoption and the establishment of a new standard of care. The launch of TOPAZ represents a step change innovation in biliary tract cancer And the strength of this data demonstrates the transformative benefit of IO in this setting. In the U.

Speaker 6

S, TOPAZ has become the undisputed standard of care within months And the EU and Japan launches are already outpacing the U. S. Trajectory. We're making progress with Poseidon in the U. S.

Speaker 6

And in Europe with a crowded and competitive setting. This launch together with our efforts with PACIFIC and Caspian continue to solidify a strong leadership position within lung cancer. In the first half of this year, we delivered 4 positive Phase III trials of novel Imfinzi combinations across lung, GI and GYN settings. Matterhorn in gastric and gastroesophageal junction cancer was the 1st global Phase III Trial of I O plus FLOT to demonstrate statistically significant pathologic complete response. In endometrial cancer, we are Excited to report that DUO E showed Imfinzi plus Lynparza and Imfinzi alone significantly improved progression free survival and Susan will cover these trials in Over the balance of the year, we look forward to additional Phase 3 readouts with PACIFIC 2 in lung cancer and EMERALD 1 in GI.

Speaker 6

Building on Himalaya, Emerald 1 and Emerald 2 will enable our leadership in HCC. Finally, we will continue to advance our next wave of IO with our novel bispecifics vorustimig and rivagostimig and sabagostimig. With that, please advance to the next slide, and I'll hand over to Susan to cover key R and D highlights in the quarter.

Speaker 7

Thank you, Dave. Next slide, please. It's been an exciting first half of the year with 8 positive pivotal trial readouts. We have a large presence at ASCO with more than 130 abstracts Featuring 22 approved and potential medicines, highlighting the momentum of our pipeline. ASCO highlights included the final overall survival from the Tagrisso ADORA trial demonstrating unprecedented survival in early stage EGFR mutated lung cancer As well as the first data from the DUO O trial highlighting the potential of PARP inhibition plus immunotherapy in advanced ovarian cancer.

Speaker 7

Additionally, interim data from the DESTINY pan tumor-two trial found in HER2 to be the first therapy to show broad activity Across a range of HER2 expressing advanced solid tumors. Since ASCO, updated data showed IMHIR2 resulted in clinically meaningful progression free survival And overall survival, and I'm pleased to share that our initial interactions with the FDA have been encouraging. As mentioned previously, we reported high level results for 8 pivotal trials this quarter. I'll touch on 3 of those readouts now. First, FLORA 2 demonstrated a strong Clinically meaningful improvement in progression free survival for patients with EGFR mutated non small cell lung cancer.

Speaker 7

Considering the EGFR mutated lung cancer landscape as a whole, We believe Tagrisso monotherapy will remain standard of care in first line, but see the opportunity for FLORA 2 to become a valuable regimen for patients with higher tumor burden. We're delighted that these dates have been selected for a presidential plenary presentation at the World Conference on Lung Cancer in September. DUO E is the 1st Phase III trial of immunotherapy plus PARP inhibition to demonstrate clinical benefit in advanced endometrial cancer. More than 400,000 patients are diagnosed with endometrial cancer each year. And in advanced disease, survival remains poor, With only 1 in 5 patients living beyond 5 years.

Speaker 7

In DUREE, both Imfinzi plus Lynparza And Imfinzi alone significantly improves progression free survival when added to chemotherapy, with the greatest clinically meaningful benefit observed With the combination of Imfinzi and Lynparza as maintenance treatment. Finally, over 1,000,000 patients are diagnosed with gastric cancer each year, 45% of whom are eligible for perioperative chemotherapy. An early read from Matterhorn demonstrated a statistically significant And clinically meaningful improvement with Imfinzi plus FLOT versus FLOT chemotherapy alone in the key secondary endpoint of pathologic complete response, Which we hope to see translate into an improvement in event free survival over time. Please advance to the next slide. We recently announced positive high level results from the 1st Phase III trial for DATADxd, the Tropion Lung 1 trial.

Speaker 7

This trial investigated DATODxd versus docetaxel in second and third line non small cell lung cancer and demonstrated a statistically significant improvement in progression free survival and an early trend in overall survival. The adverse event profile of DAS ODXD was overall with previous trials, including rates of all grade ILD. Whilst there were some cases of Grade 5 ILD In the trial, we are confident in the positive benefit risk profile for DASADXD. These data reinforce our view that DASADXD will be an important Initial interactions with the FDA have been encouraging, and we are proceeding to file TROPION Lungo 1. In addition to TROPION Lung01, we have 3 active Phase III trials in the frontline setting investigating DAT ODXD in combination with immune checkpoint inhibitors, Tropion Lung 7, 8 and Avanzar.

Speaker 7

Outcomes in this setting remain poor, less than half of patients treated With initial IO plus chemotherapy living past 2 years. Combination DATODXC plus IO has already demonstrated encouraging Clinical efficacy in the TROPION Lung-two trial with durable objective response rates of 50% for Dessa DXD plus pembrolizumab 57% for the DESO DXD plus pembrolizumab and platinum based chemotherapy across first line patients. We will have further data to support the combination in lung cancer from TROPIONLUNG04, which is a late breaking abstract at the World Conference on Lung Cancer. The combination has also shown benefit in breast cancer with begonia, where we saw a 91% disease control rate with durable responses in first line triple negative breast cancer. These results support stronger benefit of the combination of dacodexd and immune checkpoint inhibition.

Speaker 7

Moving now on to breast cancer. Our first Phase III trial is due to readout later this year. TROPI and BRASCO I investigates dATADXC versus chemotherapy in patients with hormone receptor positive, HER2 negative metastatic breast cancer that have received at least one line one prior line of chemotherapy. Our confidence in this trial is twofold. First, we saw encouraging signals from the HR positive cohort of tropionpantumor 1 With a disease control rate of 85% and a median PFS of 8.3 months in a more heavily pretreated population compared with TBO1.

Speaker 7

2nd, we already have proof of concept for trochta directed treatment in this space with Phase III data for another compound We also have 2 Phase IIIs focused on triple negative breast cancer. Tropium Breast 2 investigates whether DASADxD can replace chemotherapy in first line patients not eligible for PD-one or PD L1 inhibition. Entropion Breast 3 investigates the role of adjuvant dasa DXD with or without Imfinzi in early triple negative disease. We are on track to deliver on the promise of DATADxD in lung and breast cancer. And tropium pan tumor-one and-three are generating the data needed And with that, please advance to the next slide, and I'll pass over to Ruud to cover biopharmaceuticals performance.

Speaker 8

Thank you, Susan. Next slide please. Biopharmaceuticals delivered total revenue of $9,100,000,000 in the first half With both CVRM and R and I posting double digit growth. Within global CVRM, Farxiga total revenue grew 41% To $1,500,000,000 in the quarter, driven by continued uptake in CKD and heart failure. Farxiga is now approved in 62 countries for patients With heart failure, which preserved ejection fraction.

Speaker 8

And this quarter, we were pleased to gain approval in the United States for the liver, Which means heart failure patients can now benefit from Farxiga regardless of the left ventricular ejection fraction status. Fasenra, Rastry, TESPAI and Savnelo continued their strong momentum, delivering combined growth of 48% in the first half. These brands are becoming a larger driver of our overall performance. In the Q2, these brands made up 46% Of our R and I total revenue, up from 36% in the Q1. Next year, we will add another innovative medicine to our portfolio With the launch of Air Supra in 2024.

Speaker 8

In the Q2 Fasenra grew 16% to $406,000,000 Driven by strong demand in the U. S. And Europe as well as some favorable inventory movements in the quarter. We recently filed Fasenra for its first approval in China following positive high level results from the MIRACLE trial. The Spire delivered $81,000,000 in total revenue in the 2nd quarter, up from just $30,000,000 last year.

Speaker 8

When we look at the combined global sales by AstraZeneca and our partner Amgen, the Spire reached $257,000,000 in the half, An impressive achievement in only 1 year since launch. The Spy is now available in 11 markets And has enjoyed notable early success in the U. S, Japan and Germany with more European launches to come later this year. Symbicore total revenue in the Q2 remains stable. However, we still anticipate the entry of generic competition in the United States In the back half of the year, in VNI, we saw the first product sales for BayFortis, which is now approved In the United States, following an unanimous vote by the FDA Antimicrobial Drugs Advisory Committee supporting the BFortis benefit risk profile.

Speaker 8

AstraZeneca manufactures BayFortis and then supplies product to Sanofi for distribution and we record our sales to Sanofi as product sales. We will also book Alliance revenue earned on Sanofi's BayFortis sales outside the U. S, where we share profits with Sanofi. We're looking to make Bay Fortis available to protect infants in the U. S.

Speaker 8

And Europe ahead of the 2023 RSV season. Next slide, please. The continued growth of Farxiga is the result of a decade long development plan to broaden its use from diabetes To chronic kidney disease and heart failure patients, our pioneering research has led to Farxiga becoming the leading medicine in its class, Bringing its mortality benefits to millions of patients globally. We see further opportunities To come for the data molecule and other combination therapies, giving us the potential to address additional unmet needs among cardio renal patients and other indications. Our Farxiga combinations remain on track with plans for Phase 3 decisions later this year.

Speaker 8

With that, please advance to the next slide and I'll hand over to Mene.

Speaker 9

Thanks, Ruud. This slide and yes, we're on the right slide. Slide outlines our participation at recent medical congresses where we've showcased data for tozorakimab, our anti IL-thirty three monoclonal antibody. We also highlighted the importance of real world data and patient outcomes across R and I and CVRM. Firstly, at the American Thoracic Society Congress, lung tissue samples taken from patients with COVID-nineteen were stained and analyzed.

Speaker 9

And the images I'm showing you here show localization of higher levels of R33 in the airway tissues, providing further scientific rationale for targeting R33 in severe viral infections in our Phase III TILIA trial. Also at ATS, Real world data highlights the importance of prompt intervention with Breasttree. Initiating treatment within 30 days following a moderate or severe COPD exacerbation decreased the risk of future exacerbations by 24% versus delaying treatment by 6 months And by 34% versus delaying treatment 6 months to 1 year. At the European Renal Association, we presented real world evidence underscoring the The importance of early diagnosis of CKD. Multinational study REVEAL CKD demonstrated that 85% to 95% The Stage 3 CKD remains undiagnosed.

Speaker 9

Data also showed the delaying diagnosis by just 1 year Resulted in an increased risk of deterioration, kidney transplant or long term dialysis treatment. The Zuora study supported continued concomitant use of potassium binders in RASD patients who experienced hyperkalemia. In response, we've already seen updates to a number of CKD and heart failure treatment guidelines. Please advance to the next slide. I wanted to also take the opportunity to highlight the broad modalities and technologies we now have in our armory.

Speaker 9

Over the past decade, we have built these capabilities to provide our scientists with access to the most relevant biological pathways and targets. And as you can see, these are starting to mature and gain momentum. We have a portfolio of antisense oligonucleotides across amyloidosis, NASH And CKD in clinical development. These are precision medicine approaches that target the underlying biology of the disease In specific patient subpopulations, for example, our PMPLA III AZD2,693 dosed in Phase IIb in NASH this quarter, Following promising Phase I data, which showed a steatosis reduction and positive gene knockdown at 12 weeks. In advanced biologics, AZD8630 is a human anti TSLP fragment antibody formulated for inhaled dry powder delivery.

Speaker 9

AZD8368,630 is currently in Phase 1 in patients with poorly controlled asthma with data expected later this year. Also later this year, we're expecting data from our NGFTNA bispecific monoclonal antibody currently in Phase 2 For the treatment of OA pain and neuropathic pain. In autoimmune disease, we recently announced the collaboration with Quell Therapeutics Develop engineered Treg based cell therapies for autoimmune. Combined with our own expertise in this space, we can accelerate the development of this novel therapeutic approach with the potential to be curative in Type 1 diabetes and in inflammatory bowel disease. With the acquisition of Alexion, our gene therapy ambitions have also accelerated significantly.

Speaker 9

Utilizing our proprietary CRISPR gene

Speaker 1

editing platform to address

Speaker 10

challenging rare diseases, we

Speaker 9

are together building an to address challenging rare diseases, we're together building an approach we hope will offer better safety margins. We're also working with Alexion teams to optimize the therapeutic window through the use of novel tissue directed capsids And tissue specific promoters. The possibility of curative treatment for rare genetic disease becomes achievable when combined with the Alexion rare disease expertise. And with that, I will now hand over to Mark, who will cover the rare disease genomic strategy in more detail Along with rare disease highlights in the period. Please advance the next slide.

Speaker 11

Thank you, Mene. Can I see the next slide? In the first half, Rare disease total revenue grew 12%, contributing $3,800,000,000 Growth in the period was driven by increased demand And benefited from timing of tender market orders slightly offset by the one time pricing adjustment in the international region Recognized in the Q2 of last year. Across the portfolio, our global patient numbers continue to grow and notably, This is the Q1 ULTOMIRIS patients exceeded those of SOLIRIS. ULTOMIRIS grew 60% in the 2nd quarter, Driven by continued naive patient growth in generalized Myasthena Gravis, new market launches and successful conversion from SOLIRIS Across the shared indications.

Speaker 11

As a consequence of this dynamic, SOLIDRIS declined 19%. So I'm excited by our performance. As I mentioned in the Q1, we expect some headwinds in the second half of the year. These include pricing pressure Related to renegotiation as Ultomiris launches in larger neurological indications and potential for solid risk biosimilar entry in Europe. Also as a reminder, we benefited from tender market order timing in the second half of last year.

Speaker 11

Timing of these orders are variable throughout the course of the year, impacting growth versus prior periods. Beyond C5, both Strensiq and Kosulugo grew 25% 30%, respectively, Reflecting underlying patient demand and expansion into new markets. Please advance to the next slide. During the quarter, ALXION 2,220 Phase 1 data were presented at the European Society of Cardiology In patients with transpiriting amyloid cardiomyopathy, as a reminder, ATTR Centimeters is a progressive and fatal disease Caused by misfolding, transpirating, depositing in heart tissue. The safety and pharmacokinetic profiles OVALXION 2,220 were assessed and cardiac imaging studies were performed.

Speaker 11

As shown, the images Detail remarkable reduction in cardiac amyloid deposition over 4 12 months. These observations We are supported by change in level of cardiac biomarkers as well as functional measures. ALLEXION 2,220 It's the first and only medicine to clear amyloid deposition and it has the potential to reverse the course of disease Both as a complementary therapy with other modalities, but also as a monotherapy. We are excited by this Phase 1b Data and as previously shared, we plan to initiate a Phase III trial later this year. Across AstraZeneca and Alexion, we are looking to transform the care of trastyridin amyloidosis through multiple therapeutic modalities.

Speaker 11

Our broader immunologist portfolio includes silencer eplantersen and stabilizer Akoramidis for which we have rights in Japan. Recently, we have a positive 30 months Phase III data for Akoramidis. We've demonstrated a 50% relative risk reduction in cardiovascular Related hospitalization, building confidence in the medicine ability to stabilize disease progression. EPLONTIER SON met its primary endpoints in a regulatory transduremative amyloid polyneuropathy And we have ongoing Phase III trials in the RCM. We believe this portfolio of medicine with differentiating mechanism of action We'll address the full spectrum of disease severity.

Speaker 11

Next slide please. As you may have seen, we have done a series of small to medium sized business development deals, expanding our technologies and platform in research. I wanted to take the opportunity to highlight some of these and affirm our long term ambition to be an industry leader in genomic medicines. Approximately 80% of rare diseases are genetic driven by inherited or acquired gene mutations. By leveraging AstraZeneca technologies in non viral delivery systems and nucleases such as CRISPR, Logic Bio, GeneRide and Savi platforms, GCR G brand cargo for delivery to the central system or CNS, As well as our own proprietary platforms, we aim to address a number of genetic diseases across liver, kidney, heart and muscle and CNS.

Speaker 11

The agreement announced this morning to acquire a portfolio of gene therapy program for rare disease from Pfizer Accelerates our time frame to bring this potentially transformative and curative treatment to patients. We look forward To welcoming Pfizer employees, we have been driving this program forward, increasing our gene therapy team to over 80 specialists. Together with all my colleagues at Alexion, we are excited to continue our work developing enhanced platform in technologies, Leveraging the expertise across a larger group to deliver life changing medicines to patients where they are limited or no long term treatment option. And with that, please advance to next slide and I will hand over the call to Pascal for closing remarks.

Speaker 4

Thank you, Marc. Next slide, Please, before I make my concluding remarks, I would like to take a minute to recognize the important steps we are taking to tackle the climate crisis. In particular, our Ambition 0 Carbon program is on track, and we have made significant steps toward achieving our science best targets. Firstly, we announced our partnership with Vanguard Renewables, allowing us to deliver renewable natural gas, a source of clean heat to all our U. S.

Speaker 4

Sites, Manufacturing and R and D sites by the end of 2026. We also significantly expanded our easy for us With a commitment of $400,000,000 to plant and maintain 200,000,000 trees across 6 continents by 2,030. The expanded program will sequester carbon, support biodiversity and deliver benefits to local communities positively impacting Lastly, our transition plan is verified by the Sands Based Targets initiative, Which focuses on deep decarbonization, allowing for only 10% residual emissions removals by 2,045. Scope 3 remains to be our largest challenge and we are committed to partnering with our suppliers. Last week, private sector members of the SMIs Health System Task Force, which I convened, sent an open letter calling on suppliers to commit to joint minimal climate and sustainability targets That contribute to decarbonizing the health care value chain.

Speaker 4

We're planning playing a leading role in this space, Doing our part to limit the impacts on climate change while unlocking opportunities to deliver more sustainable health care system. Please move to next slide. We have an exciting second half of the year ahead with a number of important pivotal trial readouts, Including two trials in breast cancer, TROPION BRACE-one and NO-two ninety. 2 trials we also have two trials of Imfinzi and non small cell lung cancer And HCC, we have a trial with Fasenra in EGPA as well as the first results of our next Generation COVID-nineteen antibody AZD-three thousand one hundred and fifty two. We also have a rich catalyst passed in 2024, Which given current event prediction rates will now include the Stilibrast OCX and LoRa results from both of which we are now Which both of which are now expected in the first half of twenty twenty four.

Speaker 4

The progress that we are making in our pipeline overall is Inspiring and I'm excited for when we have the opportunity to share data to share the full data from the many studies we have showcased during this call At upcoming medical congresses. Now please advance to the next slide. Finally, before we turn to Q and A, Earlier today, we announced that Menet Pangalos will retire after almost 14 years with the company and a great 35 year career. Mene will be succeeded by Sharon Barr, currently Head of Research and Product Development at Alexion. When Alexion joined AstraZeneca 2 years ago, a key priority was Ensuring that our shared organization would benefit from the world class talent that Alexion brings.

Speaker 4

From day 1, Sharon stood out as an exceptional scientific leader. Sharon brings tremendous experience that will prove essential to advancing our BAF Pharmaceuticals pipeline along with a strong track record for driving productivity and fostering innovation. This experience, coupled with our leadership style and passion for developing people, places her perfectly to take over the reins from many and help us To ride the next chapter of success. Over the coming months, Meli and Sharon will complete an extensive handover, a smooth transition of responsibility and ensuring there are no delays to the advancements of projects, which brings me to Mene, someone who's always quick to praise others, but must take credit himself for all he has done to transform how we approach R and D, delivering a greater than Fivefold improvement in productivity, driving deeper collaborations with academic, biotech and peer organizations, Pioneering programs to promote open innovation and championing the use of new technologies and modality and last but not least, Leading up our contribution to the U. K.

Speaker 4

Life sciences sector and, in particular, building our very important Presence in Cambridge and the U. K. Mene, thank you for your contribution to our company, and I wish you only the best in your retirement. Personally, I will miss your wonderful sense of humor and your intellectual wit. But the quality of the medicines you brought to patients And the pipeline and capabilities you've built will be your legacy for many years to come.

Speaker 4

With that, I will hand the call back to Handy for our Q and A session.

Speaker 2

We will now go to the Q and A with all of our executive members participating shown here. As a reminder, you can raise your hand on Zoom or We'll try and answer as many questions as we can during the call, but please do limit the number of questions you ask to allow others a fair chance to participate And with that, we'll move to the first question.

Speaker 4

Sachin Jain, Bank of America. Over to you, Sachin.

Speaker 12

Thanks for taking the questions. It's actually Jane here from Bank of America. Two topics. Firstly, Datto in first line lung, if I may. So part of the reaction to TROP Lung01 was investor fading confidence in first line on both efficacy and safety.

Speaker 12

So I wonder if you could touch on that. Could you remind us how you interpret the 8 months of PFS we saw from TLO2 at ASCO just with a comparator, 1 in 9 months? And if Susan, you could frame expectations of what our focus should be into TLO-four that you flagged at World Lung. And then the second question is on breast cancer. A lot of news flow in breast cancer in the next 12 months.

Speaker 12

We've been particularly vocal, but I wonder if you could just touch on 2 reads. Firstly, TB01, which you talked about, but the potential for that to be better than TROPICS 2, you noted the 8 month PFS. Are you confident that can repeat and better the TRIDENTLLI 5.5 months? And then secondly, you didn't mention DBO-nine, but you've pulled that forward into 2024. So again, just talk to the confidence you've got there prior day to suggest potential for double the PFS comparator of Herceptin PEGETA.

Speaker 12

Thank you.

Speaker 4

Thanks, Sachin. So busy questions for you, Susanna.

Speaker 7

Okay. Thanks for the questions, Sachin. So let's start with ADATO in the first line Lung. First of all, I would just say that given that TLR1 is a positive study, There are things that we can learn from that. The first line lung studies are ongoing.

Speaker 7

We've obviously got TROPION Lung 7, 8 and AVANZA, which are complementary trials in In first line, predominantly in patients without genomic alterations versus the respective standard of care. And Edanzar is investigating patients regardless of PD L1 status or tumor histology. So they are complementary Segments of first line lung. What I would say is that we've now treated across all of these studies together with TL02 and TL04 For over 200 patients on the DATADXD plus immune checkpoint inhibitor combination and we're comfortable with the safety profile that we've seen Across that patient population. So I think it's important to just remember that from an ILD perspective, We know that some tumor types have a higher risk of ILD than others and that later line patients who've had multiple prior lines of chemotherapy are at higher risk of ILD.

Speaker 7

And so I think it's important that that ongoing safety profile that in first line lung is underpinning our confidence there. When you look at Tropion Lung 2 data that you highlighted, We're encouraged both by the response rate and the durability of response that we've seen from TROPIA Lung 2 for both the combination With the doublet of DATSA DXD plus pembro and also the triplet when platinum based chemotherapy is added. What you'll see in TROPION LUNG04, that's a Phase Ib study that also looks at the combination of data plus immune Inhibition in lung cancer. So it's an additional data set to TROPIA and Lungo II. And again, we're Happy to talk to you after the data presented at World Congress on Lung Cancer.

Speaker 7

For breast cancer, you asked 2 questions. One is about TROPIUM Breast 1, again, the confidence in Tropium Breast 1 is based on the data that we've seen that You've already highlighted and you've already mentioned. I mean, I would just say that for the design of Dassault DXD, we think is a best in class ADC, it's got an excellent stable linker and a proven warhead already. And so when we look across cross trial comparisons with all the caveats that those have, we've seen numerically higher response rates Across a number of different settings and that really underpins our potential to have better efficacy and have a best in class profile in that setting. But obviously, we have to wait for The actual readout of the trial.

Speaker 7

For DESTINY Bresto 9, I think See the readout time is not hugely shifted here. Obviously, all of the NHER2 trials are recurring rapidly And that helps with the time lines, but these are also event driven trials that we look for the outcome. So I don't think there's anything more than that to interpret in the Shifting the timelines. I hope that addresses all your questions.

Speaker 4

Thanks, Susanne. Tim Anderson, go ahead, Tim.

Speaker 13

Great. Thank you. So just

Speaker 4

staying on

Speaker 13

the topic of data DXT, In the light of what Troop and Longo one has shown, I know you guys say you're enthusiastic about the program. Is your enthusiasm less or tempered at all by how TLO went out Because the benefit, I mean, you guys pretty much said is modest. So I'm wondering if that does kind of temper your expectations for that program overall and what that can deliver In other tumor types or even in other settings for lung cancer? And then a second question, where are you with the retrospective biomarker analysis So TL01, is there anything you can say yet looking at results by TROP-two expression levels?

Speaker 7

Okay. Thank you, Tim. So Let me just reiterate that we're confident in the data that we've seen for TROPIA and LONGO 1. As we've shared already, we've had initial conversations with the FDA, which have been encouraging, and we're moving So we're looking forward to sharing the full data, which I think will be helpful for everybody at an upcoming conference, and that will obviously provide a more complete Picture. We're confident that the data that we've seen really, really enforces that Dassault DXD is going to be an important potential medicine In multiple cancer types, but also including in lung cancer.

Speaker 7

In terms of the biomarker analysis, Work is, as you say, ongoing. And obviously, one important source of data is going to be the TROPION LION 1 dataset. So I look forward to updating you with data once we've had the chance to complete that analysis.

Speaker 4

Excellent. And the next question is from Andrew Baum at Citi.

Speaker 3

Thank you. So top of the question, one for Susan and one for Mark. So you filed or you plan to file the trophiolung-one data with the FDA. Can I ask which population, Presumably, given you've got modest PFS, the OF is a mature? One would imagine there's a subgroup in the second line It is persuasable third line for the FDA.

Speaker 3

So could you just comment on which indication you are seeking, which population? Is it 3rd line, second line histology? I are knowing the likely response, but I'm interested anyway. And then second, Mark, in relation to your Amyloid monotoneal, where we share your enthusiasm. When we think about the outcome trial, are you going to mirror that Conducted by BridgeBio with a sort of embedded 6 minute walk as well as an outcome for mortality, for morbid mortality Or do you think you can get it approved solely on 6 Minute Walk in order to expedite the Phantom market?

Speaker 4

Susanne, do you want to start?

Speaker 7

Yes, sure. Thanks for the question, Andriy. So obviously, in the top line results, we've not by patient subset, that's entirely in line with our normal practice. TL01, it was stratified by the most immediate Cryotherapy including anti PD L1 or PD-one immunotherapy, geographical region and histology, squamous versus non squamous. It includes patients with actionable genomic alterations, but that was a later protocol amendment and it's a minority of the patients that are included.

Speaker 7

I can't really comment Ongoing dialogue with the FDA at this point.

Speaker 4

Maybe the one thing that we could add here is that, on the from what we've seen, we think this Agent, it's going to be useful in a large population of lung cancer patients. Mark, do you want to cover the second question?

Speaker 11

Yes. Thank you, Andrew, for your interest in 2020 to 2020. So we are planning this Phase 3 and we are in ongoing discussion with the FDA to confirm the protocol. You asked a very precise question on whether we were going to include the 6 minute working tests in our endpoints and the answer is no. We are probably going to finalize the endpoints on mortality and cardiovascular morbidity, Possibly with the addition of a 3rd tier endpoint, but it won't include 6 minute walking distance.

Speaker 7

Thank you,

Speaker 4

Mark. Mark Brasel, Morgan Stanley. Mark, go ahead.

Speaker 1

Thanks very much, Pascal. A couple of questions. Firstly on Calquence and one for Dave. Dave, could you help us understand the sales split for Calquence and for The BTK market in CLL between first line and second line stroke refractory patients. And if you can help us on the second line side to understand the The shared dynamics there, that could be really useful.

Speaker 1

Secondly, on the tropimin breasto-one market opportunity, Obviously, a large number of patients, I guess, in the just the third line setting alone, 85,000 patients in the G8. Could you help us understand how this fits Within HER2 in the HER2 low setting as well, so trying to think about the market opportunity before you get the data themselves. And then lastly for Susan, just a follow on to all the TROP-two testing questions. Could you help us understand going forward the importance TROPE-two testing for TROPE-two ADCs and from a regulatory standpoint, acceptance of retrospective data on TROPE-two expression And the potential to incorporate TROPE-two testing into trials which have recently started such as TL07 and TL08? Thank you very much.

Speaker 4

Dave, you're right.

Speaker 6

Yes. Thank you, Mark, for the question. So starting first with your Calquence question. In terms of just the overall new patient starts within the BTKI class, we see about half of new patient starts Of total BTKI starts are happening in CLL in the front line and then you have about half of those starts that are happening in the Relapsed refractory setting. And then you can split that half in the relapsed refractory setting into about half of those, so 25% Are in patients who are naive and the other balance of that is in patients that have been pretreated with BTKIs.

Speaker 6

So that gives you a general sense for how the class Let's out. In terms of our share of those classes, I've been very pleased with the U. S. Performance in The Q2, as we've seen in the frontline setting, our share position has held Strong as we've seen the entrance of new competition within the class. In the second line setting, As I mentioned in my prepared remarks, we have seen erosion of our share in that relapsed Refractory setting, particularly within the naive, we remain, as we see it, still the leaders within this space.

Speaker 6

That said, it is a pretty tight share split among the 3 players as we see it within that space. In terms of now switching to the commercial opportunity for TROPION Breast 1, I think that Maybe the primary thing that I'd lay out here is that I think what we're really seeking on this is category leadership within breast cancer. I think that as you quite rightly point out, across the G7 countries, there are a large number, over 35,000 4th line and beyond, patients treated across the G7 in hormone receptor positive and HER2 negative Disease. And I think that what we'll really be looking to do is understanding how patient selection and sequencing Can create opportunities both for in HER2 as well as for Datto DX. And I think that an important part of the approach that we're taking is Try to have an AstraZeneca medicine that is appropriate for patients with various different subtypes And also in various different sequence over time.

Speaker 6

And I think that I would look at the opportunity to replace chemotherapy Cross late line breast cancer as a category is how we're thinking about the portfolio of medicines.

Speaker 7

So to answer the question about biomarker development for DATODXD. So in principle, antibody drug conjugates Our targeted medicines and I think as a general principle, we want biomarkers to identify the right patients For targeted medicines across that class. And so As we've indicated, we are working on a biomarker for the TROP-two program. And we will use the data that we've got from TL01 to help with our effort and we can update you on that once those analyses are completed. I think your comment about retrospective versus prospective, obviously, in an ideal world, you want prospective Selection in order to make sure that you've got a balance and you often stratify for that presence in such trials.

Speaker 7

But there are multiple examples of where retrospective analysis based on a prospective definition of that have enabled an approval in that setting.

Speaker 4

Thank you, Suzanne. The next question is from Gonzalo Artiak at ABG. Go ahead, Gonzalo.

Speaker 1

Is that okay?

Speaker 4

Yes, we can hear you. Go ahead. We can't hear you. So let's move to the next Yes.

Speaker 14

Now can you hear me?

Speaker 4

Yes, Gonzalo, go ahead. We can hear you now.

Speaker 14

Great, great. So first one, It's regarding your yesterday's news on destinypant tumor 2. With the data presented yesterday of improved PFS and OS in line with what you showed at Asco, how much does this help for a potential tumor agnostic approval? And here, what is your view on this debate of the use of HER2 grades Or different expression levels as a biomarker for potential treatment approach. And specifically in Paragraph, where did you you didn't see any Major improvements in terms of ORR, but could you share anything on how does these new parameters, PFS and OS, look like?

Speaker 14

Thank you.

Speaker 7

Okay. Thank you for the question. So as we shared at ASCO, what we've seen with ENHUR2 in the PANCHIN So 2 study is impressive response rate and durability of response across multiple tumor types, Particularly impressive in the gynecologic cancers of endometrial cancer, ovarian and cervical, but also encouraging data across multiple other tumors. And of course, what we saw in that study was an enhanced response rate in the IHC3 plus compared with the IHC2 plus populations. So it's important just to remember that there's a mixed nature in this trial.

Speaker 7

You've got multiple different tumor types with different lines of therapy, but generally heavily pretreated patient population. And what you saw there was a response rate durability response, which is beyond what you would reasonably expect and certainly in the IHC3 plus population For a standard of care chemotherapy in that setting. So I think it's encouraging now that we've got the progression free survival and overall survival to back up that Response rate and durability of response. I do think there are differences in this setting between IHC3 plus and 2 plus which is something we've also seen in other settings as well. And that, if you like, establishes the differentiation from the standard of care.

Speaker 7

I also think it's true to say though that there are patients beyond the IHC III plus I clearly benefit in beyond what you might expect from that standard of care chemotherapy. So what I would say is look, conversations with Regulatory authorities, including the FDA, are ongoing. As I said, initial discussions are encouraging. And as those develop, we can provide more details.

Speaker 4

Thanks, Suzanne. Next question is from Richard Parkes, Alexane. Richard, over to you.

Speaker 15

Hi. Thanks, Pascal. Yes, just a couple of questions. Firstly, just to push a little bit more on TL01, Just to help me understand the difference in the level of optimism at the time of the press release and what you're communicating now because As you all know, the your omission of the words clinically meaningful is what's caused nervousness. But clearly, given the decision to fire and your optimism today, you do see the overall benefit As meaningful.

Speaker 15

So can you just help us understand a little better the context for that contradiction somewhat in the communication? Is it Additional analysis you've done since the readout? Or was there some other reason why you felt you couldn't include that wording in the press release? Second question, a bit simpler, just could you update us on progress for vorasimig to Phase III? I know we're waiting for The durability of response data at the lower dose to be presented, and I just wonder, will that be at ESMO or worldwide?

Speaker 15

Thank you. Suzanne?

Speaker 7

So the definition of clinically meaningful in terms of what clinicians are We'll take into account not only the difference in medians, but shape of the Kilometers curves, obviously, the hazard ratio, which is what the CHAL is often designed to power together with the response rate, durability response and the safety profile as well as the patient population that's included. I think what I would just reiterate really is that when we look at the data, we find data in that is encouraging. We've had discussions with the FDA. And on the basis of encouraging response, we are proceeding to file. I can't go into more details today, but we'd be happy to have more conversations when we've actually been had the opportunity to present the data at the at an upcoming Medical Congress.

Speaker 7

With regards to your question on volvastimig, the program is advancing at pace. We have indicated that we've got a number of Phase III trials in planning. We're proceeding again at pace with those. And as we Initiate those and as we have more mature data, we will share those data, but not necessarily on The time lines that you're asking for. So at the appropriate time, we will share the data in the public Congress.

Speaker 4

Thank you, Sudan. I mean, Richard, just to add, I mean, our partner, the HE Sankeyo and us actually, we have The policy of only disclosing the high level results, as you know, and not the details. So what you saw is the announcement relative To the high level results, what we have seen is the detailed results and that's probably also explained some of the discrepancies. But you'll understand better when you see the results at the Future Congress. The next question is from Christopher Oude at CED.

Speaker 16

Hi there, Christopher Yudi, CB. So I have a question on Supernova and the COVID antibody update in general. So obviously, I saw that the timeline seems to be reiterated, But we're moving toward the latter part of the half, Not so much time to get it to patients before the end of the year. So perhaps Could you just remind us a little bit about the factors determining the time from top line to EUA? And can you also talk a little bit about how you're planning to brand it?

Speaker 16

It seems that it won't be heavy shteled, but I guess That has advantages and disadvantages. So perhaps you could talk about that. And then in terms of Fasenra, The growth levers going forward and also thinking about I saw GSK has an ultra Extended half life, IL-five. So what are your thoughts around competition? Thank you.

Speaker 4

Thank you, Christopher. Ishkal, do you want to take the first one? And Orod, you take the next one?

Speaker 17

Thanks, Thanks for the question and also thanks for your continuous interest in this area. So we are continuing to rapidly advance AZD-three thousand one hundred and fifty two, which is a new long acting monoclonal antibody for prevention and treatment of COVID-nineteen for immunocompromised patient. I'm pleased to say that SUPERNOVA trial is on track. As you are mentioning, we did update the trial and that was as a result of the Trial design and that was a result of the consultation and agreement with the FDA because we believe that is the fastest way how to Achieve emergency approval for the patients in U. S.

Speaker 17

And currently, the trial is updated with the substudy or immuno bridging data. As a reminder, this is a President's study design and will allow us to have the data later this year. Obviously, as we are moving from the beginning with at pace, we will do our best to deliver AZD-three thousand one hundred and fifty two immunocompromised patients in U. S. By end of this year.

Speaker 17

Equally, we are continuing the SUPERNOVA Trial with efficacy endpoint and we believe that efficacy data readout will happen in the Q1 of next year. That will allow us to have the approval globally outside of U. S. On your branding question, thanks For that, I do agree that not having a Wushield brand name for our new next generation monoclonal antibody has its good and bad sides. We are currently in discussion both with FDA and EMA, and we will provide the update and the brand name as soon as we get agreement from those agents.

Speaker 8

Okay. Thank you so much, Chris. Quickly, the growth drivers for Fasenra in the foreseeable future, There are 3 big ones. First of all, by far, the biggest one is still biopenetration is at the low side for Biologics in severe uncontrolled asthma, depending on where you are, it's everything between 15% 25%. So there's still a huge room to maneuver In a positive way.

Speaker 8

The second one, what I said in my remarks is that China is an important growth driver. We have filed In China, based on the outstanding NIRACOL trial, so hopefully next year, we will see the results. And Last but not least, later this year, we will see the outcome of Fasenra and EGPA, which is another very important growth driver for the brand. So all in all, We truly believe that there's still a very bright future for Fasenra. Quickly, your remark about long acting.

Speaker 8

Of course, we have our own Fasenrab is every 2 months, so we don't foresee a major impact of our molecules. The class is very competitive, But once again, biopeneration across the board is still at a very low level. So more competitors will also make will grow the market In an acceptable and good way. So

Speaker 4

Thank you, Aurel. James Gordon, JPMorgan, James forward to you.

Speaker 18

Hello, James Ward and JPMorgan. Thanks for taking the questions. Firstly, a question on data, which would be, is the plan to change anything on the back of the recent data update and What might you change? For instance, could you tweak any of the trials to involve patients which you think are going to show stronger efficacy in some sort of subpopulation? And is it CHOP 2 or is it something more sophisticated that you're actually looking at?

Speaker 18

Because I saw CHOP 2 expression was like a pillow on the slide laying out the data program. Is it something else where you might end up stratifying? And will you kick off any more Datto Phase III trials from now? Or are you going to wait until you've got a bit more data from other trials to work out where the strongest efficacy is going to be generated. And then just one other question, which was in Infinity, it's a very strong growth today.

Speaker 18

But Is there anything one off here that help performance? Or actually, if we put data aside, is Imfinzi and EHER2 really going to be the 2 key growth drivers from now until the end of the decade? We really extrapolate the strong growth forward for Infinity today?

Speaker 4

Suzanne and Diana.

Speaker 7

Okay. All right. So in terms of DATO DXD new trials, let me start with that one. Yes, we are continuing to plan new Phase III trials with DATO DXD. As we had indicated at the end of last year, we continue to be excited about the potential for this molecule in multiple different settings.

Speaker 7

In terms of The biomarker TROP-two is highly expressed across many different tumor types, including lung cancer. I think in general about ADCs and prediction of ADCOM, receptor Expression is one element. Receptor internalization is another element. And sensitivity to warhead is a third element. So There are multiple elements to consider about predicting the patients that are most likely to respond.

Speaker 7

And of course, we're looking at those different elements in what we're Working on from a biomarker perspective.

Speaker 6

Thanks, Susan. James, on Imfinzi, I mean, I think the first thing I'd note is that we double clicked into it into the prepared remarks because we think that For Imfinzi going forward is an important one. We've made a series of investments into the life cycle Plan and the clinical development plan for Imfinzi and those now are paying off in terms of positive readouts and we're commercially taking advantage of that. I think that to go a little bit more specifically, somewhere between 20% 30% of the Imfinzi growth that we're seeing is coming from the established Portfolio, so the Pacific and Caspian indications where we're seeing strength in Pacific across the globe as we kind of get further away from some of the COVID-nineteen challenges. We're continuing to progress against Caspian in parts of the globe where we have opportunities, but really it's the new launches of Topaz, Himalaya And Poseidon that are making up the balance of that.

Speaker 6

Topaz has rapidly gotten to a place in the markets where we've launched, where we have market share That's well north of 50%. I'd say, Himalaya has had a nice uptake, but still quite a bit of opportunity to continue to move with Himalaya. It is a competitive context and it's one where we are certainly coming up against Therapeutic alternatives, but we like the uptake that we've had. Maybe the last proof point just to offer on this. While with Topaz in Himalaya, we have Regulatory approvals in over 50 plus markets across the globe.

Speaker 6

We only now today have reimbursement In just around 10. Now they're 10 of the largest. So it's the U. S. And Japan and we have early access that exists within France.

Speaker 6

But we still have a number of countries within Europe And a lot of countries within international, which yet to come on board. So we think the outlook for Infiniti Forward is strong.

Speaker 4

Thank you, Dave. Emily Field, Barclays. Emily, go ahead.

Speaker 19

Hi. Thanks for taking my questions. I'll just ask 2. The first one, just on Lynparza and maybe digging in a little bit more to the dynamics going on in ovarian. How much of sales is second line ovarian?

Speaker 19

And just kind of we're aware of the registration being pulled for the competitor asset, but sort of why is this impact Leading over into Lynparza, do you expect to return to growth in the U. S. For this asset? And then just a question on the raised guidance for China. I was just wondering, is this truly based on sort of improving demand in the region?

Speaker 19

Is this impacted in any way by some of the price adjustments that That are happening with the products on the NRDL. Just any incremental color you can give there? Thank you.

Speaker 4

Beth, do you want to cover the first one and Leon could cover the second one?

Speaker 6

Yes. Emily, thanks for the question. So First part of this is that if we take a look at PARP class starts Across lines in ovarian cancer, over the course of the year, the starts are declining And that is predominantly a phenomena of lower desire on the part of medical oncologists To treat in the second line setting in ovarian cancer as there has been, as you know, I think quite a lot Of changes that have been happening there with respect to competitor labels and discussion and dialogue with the FDA. Within the context of that, We've been doing a good job to continue to drive our Paola and SOLO indications. SOLO, we really have probably Fully penetrated, though there is opportunity to continue to drive HRD testing rates in the frontline.

Speaker 6

Unfortunately, a bit of what's is that those gains are being offset by some of the second line declines. Now today in terms of where we stand, the second line represents A significant minority of our ovarian cancer business. And so I'm hopeful that even with a narrower PROPEL label That we have an opportunity to continue to drive growth in Lynparza with PROPEL and in some of the other populations that I've mentioned, but it is going to be Slower progress that we're making there. I will say outside of the United States in Europe, we're making nice progress with PROPEL within Germany. We're continuing to drive growth opportunities that we have in breast cancer and also within ovarian cancer ex U.

Speaker 6

S. But I think that the growth rates that we'll see on LYNPARZA, while still in front of us, will be a bit slower. I do though look forward with optimism to hopefully having regulatory path forward with DUO E. We'll see how things net with Duo and those would certainly be enthusiastic areas for us to launch into.

Speaker 20

Yes. Regarding China guidance, I think China is this year is We have some headwinds on oncology price cuts because of NRDL renewed last year. So major oncology products get a cut. And also silicon getting to VBP, which is a large product. But actually, we should also focus on a lot of opportunities because we're launching rare disease And also, in HER2 in China, Calquence in China.

Speaker 20

So lots of new products are being launching, a little bit lagging behind the global speed But I think we are looking forward to a lot of new launches. We haven't yet launched Finzi, Topaz and also Himalaya. And we also have launching strongly into Adara indication and FLORA 2. And for inhalation Business, Symbicort is a very strong growth and BreastTree after getting to NIDR 2nd year now, so is also embracing very strong growth. And Pulmicort, after last year's VBP, we digested and this year we're back to growth now.

Speaker 20

So 4th cigar is also one of our very major important growth driver and together with Roxanne and also all the other CDM portfolio doing extremely well. So I think in the next 1 or 2 years, 3 years, we are launching a lot of communication and new products. So a little bit behind global, but also we also need to digest the VBP impact and some price cut off in our deal. Government in China is Treating innovation better than before. So I think this is also very good sign for NIDL policy, Some of the transparency and also bring quite a good policy.

Speaker 4

Thank you, Lianne. Victor Sundberg, now there. Victor, over to you. Victor, we cannot hear you.

Speaker 21

Yes, hope you can hear me now.

Speaker 4

Yes, go ahead.

Speaker 21

Yes, sorry. So I have two questions, if I may. Thank you for taking my questions. So on the outlook for 2023, I just wanted to get a bit more details on the headwinds that keeps you from raising or refining the guidance. So in China, you seem to be more optimistic, but the parameters going against you that you mentioned here seem to be quite well anticipated perhaps in the beginning of the year, say, the Symbicort generic situation in the U.

Speaker 21

S. And the NERDL impact from China in the second half. So are there other things here as well that keep you on the sideline here for a guidance Update or refinements that have surprised you a bit during the year. You mentioned inflation, so maybe a quick comment on that would be helpful. And the second question I have is on Infinci.

Speaker 21

Very strong growth across all geographies, as you said, but especially in your rest of the world category. Can you just elaborate a bit More what is driving that and how we should extrapolate in that geography and why the uptick has been so quick here? Thanks.

Speaker 4

Thanks, Victor. Adena, do you want to take the first one and the second one?

Speaker 5

Yes, sure. Thank you, Pascal. Thank you, Victor, for the question. So we are reiterating guidance for the year, and I think it's a bit of phasing and dynamics between first half and second half. In the second half, we are going to experience, as you just mentioned and I mentioned before, the Symbicore generic in the U.

Speaker 5

S. Nexium, which went generic end of last year, we started to see the impact. And again, it's a progressive impact, so again, more in the Later part of the year and decline in various other legacy brands, Dara left. So if you look at some of Other the brands that are in the other or the legacy category. The trend that It was mentioned by Dave around second line in PARP and then the pricing impacts that Leon mentioned on NRDL for Tagrisso, a lot of that went into effect sort of in the second quarter.

Speaker 5

So again, we'll see the full impact of that In the second half, I made some comments around gross margins. Flumist is again a Product that does impact our gross margin and that's again more weighted towards the second half. But really, when you look at Both from a revenue and cost standpoint, in both SG and A as well as R and D, Primarily driven by all the study starts as well as the material that we'll need to produce from a clinical supply standpoint, a lot of that is weighted towards The second half in R and D costs. So again, it's more phasing than anything else, and we are reiterating our guidance for the full year. And then Dave on Imfinzi Rest of World.

Speaker 6

So Victor, it stems back to the answer to the question that I gave previously to James. Established Rest of World is made up predominantly of sales from Japan. I think that if you take a look at a lot of the other international markets, They sit within emerging markets. So the success that you see in the quarter for Imfinzi and Judo is really driven by very rapid up take that's been happening over the course of the half with Topaz ONE. And then also within the last quarter, we've had reimbursement from Judah that's allowed us be able to move forward with Himalayan.

Speaker 4

Thank you, Dave. Steve Scala, do you want to go ahead, Steve?

Speaker 22

Thank you so much. Two questions. First for Dave. In the Q3 of 2022, you said that HER2 Could be one of the largest medicines in oncology. Are you willing to say the same for Datto DXD based on what you now know?

Speaker 22

And second for Susan, does AstraZeneca plan to alter the study design of TROPION Lung 7 and 8 Based on the results of TL01. Thank you.

Speaker 6

Thanks, Steve. I Continue to believe that INHERTY has the opportunity to be one of the largest medicines and certainly one of the most transformative Medicines in the treatment of cancer. I will just come back to we've talked a lot on Enerto about Three important pillars and the pan tumor O2 data and Susan talked about that in greater depth earlier really does begin to open up the opportunity to Taken HER2 into areas outside of breast, gastric and lung cancer, and I think is really promising for that. And with Datto, I would say similarly that I confirm my enthusiasm for Datto's opportunity to Potentially as big as in HER2 and I think that it's going to be an important medicine. Certainly also relative to last quarter, having a positive Phase 3 readout reinforces Confidence in the ability to be able to take a program forward and I think that that's a big driver of it.

Speaker 6

And I think that last thing, when we did the deal on data, we knew that there was a big opportunity To replace systemic chemotherapy in lung cancer and also in breast cancer, the real opportunity for datto to be bigger than in HER2 Would be if we can take it into tumor types outside of those two areas. And so that's really what we look forward to seeing if we're able to effectively do.

Speaker 4

Thank you, Dave. I'm just also will state the obvious, which is we have a lot more data points for an R2 than we have for data. We need to keep this in mind, of course, The potential is indeed very large. Simon Becker, Simon,

Speaker 1

do you have There's

Speaker 7

a second question.

Speaker 4

Sorry, there was a second question. Sorry.

Speaker 7

It didn't have for me. So Thanks for the question, again. So I think I said before TROPIA and Lung01 that I expected that we were going to learn some things from that trial. And indeed, there are learnings in TL01 as you from any clinical trial, particularly the 1st pivotal trial. So it's normal practice for drug development that as you go along and you learn, There may be adaptations to trials.

Speaker 7

So I think that's just a normal part of drug development. And I'd just I'd say, look, we remain confident that the data of the Xdray will be important medicine in lung cancer, including in the first line settings of the trials that are already ongoing.

Speaker 15

Thank you.

Speaker 4

Thanks, Sylvain. Simon, do you want to go ahead?

Speaker 23

Thank you, Pascal. Yes, two questions, if I may, please. Firstly, on the Pfizer deal. You did allude to it on the slide a little bit, but I wonder if you could give us a bit more color on what you're buying. Is this more technology Rather than specific products, you highlighted some of the capsids on there.

Speaker 23

And specific to those, are there any characteristics of that that Pfizer brings That are differentiated in terms of selectivity and payload capacity. And then secondly, a question on brazikumab and Inflammatory bowel disease. Now that you've written off and terminated that project, I just wonder what your level of interest In that space, still was. I see you've done some work with NLRP-three inflamazone inhibitors, but is this still an area that is on under active development?

Speaker 4

Thank you, Simon, to take us away a little bit from Dato. But Marc, you can go ahead and then Mene.

Speaker 11

Yes. So happy to Damon, thank you for the question and happy to talk a little bit about gene therapy. So basically the agreement with Pfizer Concerns about a dozen preclinical construct and assets and also a large number Of Capsid that have been developed over the years and that can be probably further refined to get the Best possible capsid for both CNS or cardiotropic asset. So it's a combination of a dozen projects who could start clinical probably from next year over the next 1, 2 or 3 years Plus, other technologies, including capsids, which could be further refined, but we need to work on those To get the ultimate tropic for the right tissue tropism for the right tissue, sorry.

Speaker 4

Thank you, Marc. And I think I look forward to the day when we can actually show you the progress we're making in the Alexion portfolio, the pipeline. It's very exciting, but it's also true for the cardiovascular, respiratory immunology portfolio. And at some point, hopefully, in the future, we can spend more time on those products because many of those are exciting. We're also making progress in Vienna even though it's much more at an early stage.

Speaker 4

With that, Mene, you want to cover the question that Simon Yes.

Speaker 9

And it's a great question. And the answer is we have an interest Both in terms of building our immunology capability and autoimmune disease and specifically in diseases like IBD. And I'll give you Two examples and again this is I'm sure it's something that Sharon will be talking about over the coming year. The first program is an anti CCR9 antibody that's in Phase 1, which has demonstrated really dramatic lowering of T regulatory cells in the gut And it looks like a very interesting mechanism and antibody and we're looking to see how we can accelerate that. And you may also have read about a deal we did with a small company called Quell In the Treg space and I talked about it today in my presentation, they have a really interesting way of locking Treg cells to Maintain their anti inflammatory state and one of the indications that we were pursuing with them is IBD.

Speaker 4

Thank you, Mene. We have a few more So we'll maybe extend by 5 minutes, but if you don't mind, if you could ask one question this time. Simas Fernandez, go ahead.

Speaker 24

Yes, thanks. So Just a quick question on the change in leadership and Mene's retirement. It's interesting to see that Sharon is coming in from Alexion. Is this a directional move away from sort of more primary care type opportunities? I know this is something, Pascal, you have talked about Before, but there's a lot of interest in opportunities to treat metabolic disease.

Speaker 24

Just interested if there's this is a strategic shift away from diabetes and metabolic disease, perhaps obesity opportunities Or if we're going to see AstraZeneca continue its efforts along those lines or perhaps even accelerate those efforts Through business development going forward. Thanks.

Speaker 4

That's a good question. Actually what it is, is very simply The appointment of a very talented scientist and a very an exceptional leader, it's not reflecting A change in strategy, certainly not reflecting that we want to consolidate rare disease and the biopharm business because Sharon, he's being replaced in a role as Head of Research and Product Development at Alexion. And it's also not reflecting a move away From all this engagement from Primary Care, I mean, I'm sure you've noticed that looking at ourselves, but also our portfolio, you've noticed that suddenly over the last Naturally, our portfolio has moved to more Specialty Care, but Primary Care remains important. And that's why a few minutes ago, I was saying We look forward to the day when we can talk about what we have in R and I, but also in cardiovascular medicines. We have quite a few projects.

Speaker 4

And Meny, maybe you want to also to comment there on the portfolio we have in fact. Yes.

Speaker 9

I mean, I think when we have a chance hopefully in the next Some 6 to 12 months to talk about all of the assets both early, mid and late stage assets across CVRM, across respiratory immunology, VNI. I mean, it's a very rich and deep portfolio with many, many opportunities, many of them significant. We are moving more to specialty, but there's still a place For Primary Care and Sharon, I can just echo what you're going to say. She's going to be a fantastic leader for us. It doesn't reflect any change in strategy, more continuity.

Speaker 9

We're hopefully going from strength to strength and building on what we have already built.

Speaker 4

One thing that certainly Sean can help us do is continue building this focus in immunology, sorry, that Mene started and That will be an important chapter of our future. Matt Weston of Credit Suisse.

Speaker 25

Thank you, Pascal. Can I ask a question about IRA Part D reform? So at face value, Astra's oral oncology business It's going to face significant headwinds over the coming years as pharma's contribution to catastrophic cover in Part D steps up significantly. But offsetting that, there's also the potential for volume uplift on lower co pays and reduced foundation support. I wonder if Dave could walk us through the pushes and pulls For the oncology business and whether he sees it as a meaningful net negative, something that washes its face or maybe even a net positive.

Speaker 25

And if I am allowed, Pascal, I know you said one, can I cheat? Susan, on TL01, when do you expect the OS data to be mature? And will you present the PFS data before the OS data is available?

Speaker 4

Thank you. So thanks, Matt. So on the IRA, It is in term of co pays, etcetera. I think it's probably a small positive for primary care products and a big positive for a bigger positive For oncology, not only oncology, but more expensive oral medicines. And with this, I'll Hand over to Dave, who can comment more specifically on oncology.

Speaker 6

Yes. So if we take a look at the first part, Matt, of the question, we haven't Shared now for quite some time specific product level breakdown of percent of business that's within Medicare Part D, what we have Shared that across the AstraZeneca Complete portfolio, the 25% to 30% of it is Part D. And you're right that The oral oncolytics are above that average relative to kind of understanding the magnitude of the exposure here. So certainly, you can model out what the impact of having to pick up catastrophic looks like. I will say though that it is an important That comes with the ability to be able to have co pay capped And also smooth over the course of the year with these expensive oncologics, really the co pay exposure that patients in Medicare plans face on the affordability is quite significant.

Speaker 6

There's no mechanism for industry to be able to help in the way that we do With programs in the commercial side of things. So while $2,000 of co pay may be a barrier For a number of patients still within the United States, particularly within the some of the elderly populations, we do think that there's an important reduction that's going to happen here. Overall, we'll have to see how much we're able to actually get patients off of free goods programs as a result of this And we'll keep that we'll keep you updated on that as it unfolds and we'll start to find out next year actually as co pay Moves down to a 3,500 cap on January of 2024.

Speaker 4

So

Speaker 7

thanks for the question, Matt. So As you're aware, we've not indicated when the final OS analysis are going to be conducted for TL01. When we've got it's an event rate driven as And when we've got the projected event rate, we can update that. But just for you, in the meantime, when considering The outcome and the maturity, just bear in mind that this is the 2nd third line non small cell lung cancer patient population. And unfortunately for those patients, Median OS is still not long.

Speaker 7

So with docetaxel, it's in the 10 to 12 month range is typically what you would expect. So it's not hugely And prolonged versus progression free survival.

Speaker 4

Thanks, Julian. So Eric Loberico, can I ask everybody to stick to 1 and not cheat? Please, Eric.

Speaker 10

I would like to try. First was on HCR 3 actually as a target In ATC, still continuing to see good data coming from your partner's product, and some physicians would like you to embark into this As well. Is there any option? And are you still discussing to get access to it? And if not, Are you nonetheless interested by these targets?

Speaker 10

And are you then considering doing one proprietary product With any kind of construct. And maybe if I can try a very, very short one in rare disease, Putting together SOLIRIS and NUTAMARIS, until the R and D delivers, we'll represent probably 80% of sales for the next 2 or 3 years, With some biosimilars coming in Europe first and competition growing, can you maybe give a little bit of Confidence into the ability to maintain our slightly gross sell for the 2 together for the next 2 or 3 years? Thank you.

Speaker 7

So back to the question about the HER3. You're talking about pertitimab and daruxtecan. So obviously, there's going to be some data presented at the upcoming World Congress on lung cancer. Obviously, we've got an ongoing clinical collaboration with Daichi Thank you on this as part of the ORCHARD study in patients with EGFR mutated and non small cell lung cancer looking in combination with osimertinib in that setting. When we're looking at ADCs in general and making some of the choices that we've made in recent business development in that Space, we're looking at the overall benefit risk ratio versus what we've already got with our internal assets and already partnered assets.

Speaker 7

So we'll look forward to seeing the updated clinical data both as monotherapy and in combination with osimertinib which we get access to. And we I'd also just say, look, we're excited about our internal portfolio that's progressing. We have a B7 H4 ADC. We now have The EGFR met by specific ADC and a folate receptor alpha targeted ADC all with our proprietary linker warhead with the topoisomerase warhead. So these decisions are made in the context of that internal portfolio that we've got as well.

Speaker 11

Eric, thank you for your On the future of the C5 franchise. So if you refer only to SOLIRIS and ULTOMIRIS, there will be a continued growth And it will be supported by both regional expansion, but also by extension of indications. But I want to take the opportunity to also signal or remind you of the 2017, 2020, the MINI body, Which is our 3.5 3rd generation, which is presently undergoing Phase III trials, which could also provide Some further options to physicians and patients. Thank you, Marc. We'll take 2 more questions, and then we'll have to close for the day.

Speaker 11

Peter Welford, over to you, Peter.

Speaker 15

Thank you. I will just stick

Speaker 26

to one question I'd ask. So we'll start with it's China. I wonder given the changes that you mentioned with regards to the NRDL and some of the recent sort of reforms we've heard, Just wondered if AstraZeneca's attitude towards China and investment there has changed at all. I mean, recently, you've sort of cooled a little bit with It would be expansion of spend and investment in the country and even perhaps pull back on some resources. Just wondering your current thoughts on investment and further in China from here and whether there's any change at all in how you see the longer term market there with the changes.

Speaker 26

Thank you.

Speaker 4

Let me call this one if I may, Liam, because of course, you're going to be positive, right? Yes, I mean, actually, we are very committed, Peter, and China Is and we remain a very important country for I think for the industry, but certainly for AstraZeneca. We are very committed. We are building our presence in rare diseases. We've just approved the build of a A very important factory in China, in Jingdao, to make inhalers For China and potentially export out of China to some emerging markets.

Speaker 4

So we are definitely committed. We have a strong R and D team. We're also, as I've said before, leveraging our connections to partner with local biotech companies and help them Develop and commercialize the products globally. So it will remain a very important country for us, not only because we have products to sell to help patients there. And as you know, there are lots of patients, but also because it's a source of innovation.

Speaker 4

And it is for us becoming Or has become some time ago already actually a strategic center. Anything you want to add there, Leon?

Speaker 7

Yes. I

Speaker 20

think Pascal mentioned quite Completely. I think I really hope you can pay also more attention to outside China because outside China emerging market is larger than China now And growing much faster. And I think there will be a lot of opportunity and untreated and diagnosed patients opportunities there. And within China, we still have a lot of products like Biologics Fasenra and all these important new launches. We're still very excited and look forward.

Speaker 20

And it's a source of innovation and it's a manufacturing center and it's also a big market.

Speaker 4

That's a good point. I mean, outside of China, the growth was 38% first half. I'm sure you noticed that every region of the emerging markets regions is growing very strongly. We've been accelerating the catching up on the approval of new products and launching them. So a lot of growth today and also to come.

Speaker 4

So maybe the last question, Louisa Hector of Berenberg. Louisa, go ahead.

Speaker 27

Thank you, Pascal, and maybe a chance To say thank you to Mene for sharing his insights over the years

Speaker 17

and for your discussions in R and D productivity.

Speaker 27

And so many maybe a question for you on that. So your slide on the breadth of platforms in place in biopharma, my question there would be that Actually, much of Astra's success has come from the simplicity of small molecules and antibodies. So with these novel platforms there, does it change anything in the R and D decision making processes? I think you're at 6 hours, maybe more now, but How does anything change in that decision making given the complexities of these exciting platforms? And do they carry more risk?

Speaker 9

Thanks, Luisa. First of all, thank you. And the reason why I wanted to show the platform is because we have been building them for a long time. And of course, monoclonal antibodies and small And small molecules remain a very important part of the pipeline and you know many of the molecules that we have across the pipeline across both oncology And biopharm, but these next generation platforms are important because the reason why we fail today Predominantly, it's because our scientific hypothesis is wrong. As we go into more genetically validated targets, quite often you can't target them With a monoclonal antibody or a small molecule, so having access to gene editing, oligonucleotides, advanced biologics gives you a chance to Attack more complicated pharmacology and disease and hopefully improve your probability of success and that's what we've been trying to do.

Speaker 9

So it's not that we're not interested in small molecules or

Speaker 4

To finish, Louisa, thank you for this. So we'll end the Q and A here. Thank you again for all your great interest in our company, and I wish you all

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Earnings Conference Call
AstraZeneca Q2 2023
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