GSK delivers sales and earnings growth in Q2 2019

Issued: London, UK

Total EPS 19.5p, +>100% AER, +>100% CER; Adjusted EPS 30.5p +9% AER, +4% CER

Financial and product highlights

• Group sales £7.8 billion, +7% AER, +5% CER. Pharmaceuticals £4.3 billion, +2% AER, -1% CER;
  Vaccines £1.6 billion, +26% AER, +23% CER; Consumer Healthcare £1.9 billion, +5% AER, +4% CER
• Shingrix sales £386 million, driven by continued strong launch execution in the US
• Total Respiratory sales £752 million +16% AER, +12% CER. Trelegy Ellipta £120 million +>100% AER, +>100% CER,
  Nucala £195 million, +38% AER, +33% CER
• HIV sales £1.2 billion +2% AER, -2% CER. Tivicay and Triumeq sales £1 billion -3% AER, -6% CER. Juluca and Dovato sales £89 million
• Total Group operating margin 19.0%
• Adjusted Group operating margin 27.8%, down 1.0 percentage point AER, down 1.4 percentage points CER (Pharmaceuticals: 29.2%; Vaccines 38.6%; Consumer Healthcare 20.4%) with increased investment in R&D, up 20% AER, 16% CER
• Total EPS 19.5p, +>100% AER, +>100% CER reflecting lower charge for quarterly revaluation of HIV business and, following the buyout in Q2 2018, absence of Consumer Healthcare put option charge
• Adjusted EPS 30.5p +9% AER, +4% CER reflecting operating performance and settlement of open tax matters
• Q2 net cash flow from operations £1.4 billion. Free cash flow £0.4 billion
• 19p dividend declared for the quarter; continue to expect 80p for FY19
• 2019 Adjusted EPS guidance improved to expected decline of -3% to -5% at CER from -5% to -9%

Pipeline update and newsflow

• Oncology:
  • Positive headline results from PRIMA trial for Zejula as 1L maintenance therapy for ovarian cancer regardless of biomarker status. Full results to be presented at an upcoming scientific conference
  • sNDA accepted by FDA for Zejula for priority review in late stage ovarian cancer following QUADRA trial
  • Bintrafusp alfa (M7824) alliance with Merck KGaA, Darmstadt, Germany progressed to pivotal phase III in biliary tract cancer
  • Positive ICOS phase II data in solid tumours to be presented at an upcoming scientific conference
• HIV:
  • Two-drug regimen Dovato (DTG+lamivudine) approved in Europe for treatment naïve HIV patients
  • Positive 96-week follow-up data from GEMINI study of Dovato versus three-drug regimen and positive TANGO study demonstrating efficacy of switching treatment experienced patients to Dovato to be presented at IAS
  • ATLAS study for eight-week dosing of cabotegravir + rilpivirine expected in Q3
• Respiratory:
  • Nucala for severe asthma approved in US for new at-home self-administration option
  • Positive results from pivotal CAPTAIN study for Trelegy Ellipta in asthma
• Vaccines:
  • Shingrix approved in China for prevention of shingles in adults aged 50 and over
• Phase III start for otilimab (anti-GM-CSF) for rheumatoid arthritis
• For H2 2019, six potential major regulatory submissions: Zejula 1L ovarian cancer, belantamab mafodotin in multiple myeloma; dostarlimab in endometrial cancer; Trelegy Ellipta in asthma; fostemsavir in HIV; daprodustat for anaemia (Japan)

Emma Walmsley, Chief Executive Officer, GSK said:

“GSK delivered continued good operating performance in Q2 despite the loss of exclusivity of Advair. We are increasing our expectations for the year and have updated our guidance for 2019.

"We remain focused on strengthening our R&D pipeline and the execution of new product launches. Positive clinical data received so far this year offer significant new opportunities for products in Oncology, HIV and Respiratory and we expect more important readouts in the second half of the year. We also expect to complete our joint venture with Pfizer shortly, laying the foundation for the creation of two great companies: one in Pharmaceuticals/Vaccines; one in Consumer Healthcare.”

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About GSK

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com/about-us

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