Bavarian Nordic looks to go big on back of smallpox vaccine

Smallpox vaccine developer Bavarian Nordic says it will expand its infectious disease and cancer pipeline and grow its manufacturing network, possibly through M&A.

Danish vaccine maker Bavarian Nordic laid out its growth vision during it second quarter 2019 financial call, and said it hopes to be a leading and profitable biotech company by 2023.

To do this, the firm will look to its smallpox vaccine business as a starting point. Bavarian Nordic has a long-term contract for the manufacturing and storage of its smallpox vaccine worth upwards of $539 million (€474 million) with the US government, and CEO Paul Chaplin said the firm’s first goal is to maintain its leadership in the space.

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“To do this, we need to finalize the development, not only the approval of the liquid-frozen in the coming weeks but also the freeze-dried, and to secure broader sales,” he said.

The vaccine itself is based on Bavarian Nordic’s vaccine platform technology, which uses the inability of its Modified Vaccinia Ankara (MVA) virus to replicate in a vaccinated individual, in contrast to traditional smallpox vaccines.

“We are the only company providing a smallpox vaccine that’s safe for the entire population. We’ve had a very strong relationship with the US government and have received funding to the tune of almost $1.8 billion. That has allowed us to complete 22 clinical studies, deliver 28 million doses through the Strategic National Stockpile, and we have now submitted our first BLA for the initial liquid-frozen formulation.”

But beyond smallpox, Chaplin told stakeholders the firm will expand and advance its pipeline of infectious disease programs as well as establish a cancer immunotherapy portfolio.

“We need to move forward and launch our RSV vaccine in the next five years, advance our partner programs with Janssen and bring more programs through into the clinical pipeline in the years ahead,” he said.

And in oncology he added: “We want to continue our current strategy of combining our various vaccines with the standard of care, including checkpoint inhibition… [as well as] explore more advanced combinations and treatments, which will be initiated later this year.”

Manufacturing ambition

Bavarian Nordic’s fourth goal is focused on its manufacturing capabilities.

“One of our key strengths is our ability to manufacture, and we want to build upon that, look to expand our capacity and to potentially manufacture for others,” said Chaplin. “And we want to build a commercial infrastructure to drive profitable growth, potentially accelerating our ambition by looking for M&A opportunities that may be out there.

The firm has bulk vaccine capabilities in Kvistgaard, Denmark, and is constructing a $75 million fill/finish plant  on track to be finalized by the end of the year, with production expected to begin in 2021.

“[The fill/finish plant] is the single largest CapEx investment Bavarian Nordic has entered in our history. However, it’s one that will return the company to profitability. It will allow us not only to manufacture the bulk vaccine, which we’ve been doing for more than a decade, but it will now allow us to both freeze-dry and fill liquid-frozen products.”

Bavarian Nordic’s approach comes months after the firm spoke about opportunities to carry out contract manufacturing, though this strategy was not spoken about during this more recent call.