AstraZeneca PLC (NASDAQ:AZN) Q3 2023 Earnings Call Transcript

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Even today, roughly 6% of EMR data is still unstructured application of novel technology to lung cancer screening enabled analysis of over 6 million handwritten documents in just one-day and led to over 25,000 high risk patients being reassessed. We plan to scale this technology to additional health systems and tumor types, including breast cancer. We also apply large multimodal data sets to our clinical trials to help identify the right patient population for trials and to deliver more personalized precision medicines and improve the success rate of our studies. Finally, we’re using AI and predictive analytics to inform more precise, tailored engagements with physicians using the preferred communication channel at a time when they’re most likely to engage with potentially eligible patients.

Our investments in AI have yielded important actionable insights into how we can continue to best serve our patients globally. And with that, please advance to the next slide and I will hand over to Dave.

David Fredrickson: Thank you, Aradhana. Next slide please. Oncology delivered solid performance in the year-to-date period with total revenues of over $13.5 billion, an increase of 20% versus the prior year driven by strong global demand, reinforcing both the value of our portfolio as well as the continued execution by our global teams. Turning now to our key medicines, in the third quarter Tagrisso global revenues grew 6% fueled by continued demand for ADAURA and FLAURA. In China we saw some market impact from the anti-corruption campaign but we have already observed recovery into the fourth quarter Lynparza delivered 8% product sales growth in the third quarter driven by double-digit growth and establish rest of world and emerging markets.

Lynparza extended its leadership position in the PARP inhibitor class globally, despite decreasing class use and the second line label restriction in ovarian cancer in the United States. We continue to accelerate our IO portfolio with a competitive class in the third quarter. Imfinzi total revenues inclusive of Imjudo delivered 54% growth driven by new launches. Calquence total revenues increased 15% driven both by expanded access in Europe and demand growth globally. Enhertu total revenues of $339 million in the third quarter increased 86% year-on-year and in the U.S. Enhertu new patients share and Enhertu positive metastatic breast cancer and Enhertu low post chemo metastatic breast cancer remain above 50%. We continue to see strong demand growth globally particularly in European markets driven by recent launches of DESTINY-Breast03 and DESTINY-Breast04.

In the quarter, Enhertu became the first antibody drug conjugate approved for lung cancer in Europe and Japan. And we received approval for Calquence in China. At ESMO, we presented updated FLAURA2 data, which Susan will cover shortly and we’re excited to have been granted priority review for FLAURA2 in the United States. We also received FDA acceptance for a GN. These two important potential treatment regimens advance our ambitions in lung cancer. Next slide please. Looking ahead, we’re well positioned within our oncology portfolio, focusing on two medicines and increasingly competitive markets Tagrisso and Calquence. We are confident and sustained leadership and future growth. We’re well on our way to establishing Tagrisso at every stage for patients with EGFR mutated, non-small cell lung cancer supported by its best-in-class, once daily oral regimen and leading benefit risk profile.

With ADAURA, we have the opportunity to further accelerate testing, referral and treatment rates in the resectable setting and to expand access through global reimbursements. The LAURA trial anticipated to read out in the first half of next year presents the opportunity to leverage our existing presence in unresectable stage three with specific and offer targeted therapy for EGFR mutated patients. Next in the frontline metastatic setting, we continue to see increased real-world duration of treatment driven by patients gaining sustained benefit on Tagrisso monotherapy. FLAURA2 represents the opportunity to build on FLAURA, further extending duration of treatment and offering a best-in-class option for the subset of patients that may require more intensive treatment upfront.

Novel lifecycle management and combination opportunities allow for continued reinforcement of Tagrisso is the backbone TKI of choice in non-small cell lung cancer. Calquence remains the leading BTK inhibitor across all indications in the face of increasing class competition. And we’ve seen clear recovery in the relapsed refractory setting. Going forward, we’re confident Calquence will continue to maintain leadership globally, despite increased competitive pressures, reinforced by strong efficacy and differentiated safety. With that, please advance to the next slide. And I’ll hand over to Susan to cover key R&D highlights in the quarter.

Susan Galbraith: Thank you, Dave. Over the past quarter, we’ve had a significant presence at key oncology congresses, including the World Conference on lung cancer and ESMO. We continue to consolidate our leadership position in lung cancer with data from FLAURA2 unveiled at World Congress in lung cancer. These data demonstrated that Tagrisso plus chemotherapy extended the median progression free survival by nine months compared to Tagrisso alone in patients with first line EGFR mutated non-small cell lung cancer. This is the longest median PFS that’s been seen to-date in the setting. Further data to ESMO underscore the critical importance this regimen has for patients with the greatest unmet need, including those with CNS metastases at diagnosis.

In these patients Tagrisso plus chemotherapy resulted in more than 50% complete responses. FLAURA2 reinforces Tagrisso as the background therapy in EGFR mutated lung cancer, and the data have now been published in the New England Journal of Medicine. At ESMO, we expanded on our footprint in gynecological cancers with presentation of the DUO-E data. This trial is the first to show increased benefit of combining both an immune checkpoint inhibitor and PARP inhibitor in the first-line advanced endometrial cancer setting and demonstrated a deeper benefit with Lynparza in the proficient MMR and PD-L1 positive populations. We are in discussions with regulatory agencies around plan submission. We also had the first two positive Phase III presentations for Dato-DXd, with data from both TROPION-Lung01 and TROPION-Breast01 presented at ESMO.

These underscore its potential to replace backbone chemotherapy in these settings, with both trials demonstrating the clear efficacy improvement of Dato-DXd versus conventional chemotherapy, together with an improved safety profile. Dato-DXd best-in-class profile opens up future opportunities, the combination with both IO and platinum chemotherapy and builds confidence that its potential in earlier lines and other tumor types. We’re moving to filing in both lung and breast cancer. Next slide please. Our bispecific portfolio is designed to display this current standard of care immune checkpoint inhibition. These molecules are engineered to simultaneously inhibit two immune checkpoints eliciting different biological effects compared with existing concurrent combinations.

And early data suggests potential both as monotherapy and in combination with existing treatments, such as chemotherapy. We’re also combining our bispecifics with our ADC portfolio in Phase II trials. We are encouraged by the early data for volrustomig our PD-1, CTLA-4 bispecific. In first-line advance lung cancer, volrustomig 750 milligrams plus chemotherapy resulted in similar objective response rate as the higher 1500 milligram dose with improved tolerability. In Treatment naive advanced renal cell carcinoma data at ESMO demonstrated deep and durable responses at the 750 milligram dose, with a response rate of 48%, a complete response rate of 10% and a 12-month progression free survival rate of 52%. Again, we saw improved tolerability compared to the higher 1500 milligram dose.

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