Seqirus

In 2016/2017, Seqirus continued to strongly focus on business turnaround and completing the Novartis influenza vaccines business integration. We remain on track to profitability.

Total revenue for the period was US$900 million, representing strong growth of 23% at constant currency. Seasonal influenza vaccine sales in the US continued to generate the majority of revenue, supported by solid contributions from our global pandemic franchise and our vaccine and pharmaceutical in-licensing business in Australia and New Zealand.

During the 2016/2017 Northern Hemisphere influenza season, Seqirus was the first manufacturer to achieve US FDA approval for product release in the US market, reflecting ongoing efforts within the business to build a reputation for early and reliable supply. We also laid the foundation for future growth with the launch of three new influenza products in the US:

  • FLUAD®, an egg-based adjuvanted influenza vaccine for people aged 65 years+, manufactured in Liverpool, UK;
  • FLUCELVAX QUADRIVALENT®, a cellbased influenza vaccine for people aged 4 years+, manufactured in Holly Springs, US; and
  • AFLURIA QUADRIVALENT®, an egg-based influenza vaccine for people aged 18 years+, manufactured in Parkville, Australia.

With our global manufacturing network, dual production technologies and differentiated products, we have been able to establish an industry-leading portfolio in the US and are well positioned to compete in the 2017/2018 Northern Hemisphere season.

In Europe, market conditions for influenza vaccines continue to be challenging due to the predominance of short-term tenders and relatively low vaccine coverage rates. However, we were able to maintain share while continuing to lay the ground work for future growth, which includes the launch of FLUAD in the UK and the introduction of a quadrivalent influenza vaccine in the region.

In the 2017 Southern Hemisphere season, we achieved first to market in Australia with AFLURIA QUAD® and regained a share of the National Immunisation Program. Our in-licensing division in Australia and New Zealand also performed very well, largely driven by the highly successful launch of ZOSTAVAX* , shingles vaccine, on the National Immunisation Program and solid growth across the pain portfolio. We also divested our logistics business in Australia, enabling greater focus on our core business.

Latin America is a key growth market for Seqirus, and this year we were first to market in Argentina with AGRIPPAL®, our egg-based trivalent influenza vaccine, manufactured in Liverpool. In addition, we finalised new supply agreements with the Sinergium Consortium and the Argentinian Government. As part of these agreements, we commenced the transfer of fill and finish technology for AFLURIA QUAD to Argentina, strengthening our supply capability.

During the reporting period we increased our focus on the growth potential of our pandemic franchise. We continued to meet our pandemic readiness obligations to governments around the world, including the extension of our biosecurity agreement with the Australian Government. We also entered into new agreements to manufacture stockpiles of H7N9 influenza vaccine, triggered by growing concerns about the pandemic potential of the H7N9 virus.

Additionally, we contributed to the Pandemic Influenza Preparedness (PIP) Framework and made a commitment to the World Health Organization (WHO) to donate 10% of our real-time influenza vaccine production to developing countries in the event of a pandemic.

Achieving operational excellence across our global manufacturing network is an important part of our growth strategy. We continued process improvement programs at all Seqirus sites this year with a particular focus on realising the potential of the cellbased technology at Holly Springs. We also announced new investments at our Liverpool site which will give us greater control over our global supply chain.

As part of our transition to full operational independence from Novartis, we implemented a new Seqirus information technology platform in 2016/2017, began the roll-out of a single enterprise resource planning system for our global business and launched several new cloud-based applications. This has enabled us to exit the majority of our transitional service agreements with Novartis.

The timely execution of our R&D strategy is critical to our turnaround plan and future growth. Through 2016/2017, our R&D group delivered major regulatory filings to support the launch of new products and age indications, and also progressed important clinical programs to develop a paediatric indication for both FLUAD and AFLURIA QUADRIVALENT and a quadrivalent formulation of FLUAD.

In March 2017, we moved our Centre of Excellence for Influenza Research into new laboratory space in Cambridge, Boston, US. A key achievement for the research and technical development teams during the period was the successful first time use of a H3N2 cell-derived candidate vaccine virus to produce commercial volumes of FLUCELVAX QUADRIVALENT.

This major advance was the result of a multi-year collaboration with the WHO collaborating centres in Melbourne and the US Centre for Disease Control and has the potential to produce an influenza vaccine that in some seasons may be better matched to circulating strains than egg-based alternatives.



Seqirus’ state-of-the art Holly Springs manufacturing facility in North Carolina US.

Seqirus’ state-of-the art Holly Springs manufacturing facility in North Carolina, US. In an industry first, Seqirus has successfully produced cell-based influenza vaccine at commercial scale using a candidate vaccine virus that has been isolated and grown in cells, rather than in hens’ eggs.