Circassia Pharmaceuticals outlines plans for a busy 2019

Specialty pharmaceutical company Circassia Pharmaceuticals updated the market on its current trading on Friday, reporting that it ended the year with cash, cash equivalents and short-term deposits of approximately £41m.

The London-listed firm, which was holding its annual general meeting, said that during 2018, it continued its robust focus on cost containment, and as a result net cash outflow for the year was expected to be less than £20m.

It said it expected revenue for the full year to be in the range £48m to £52m, following higher Tudorza rebates in federal channels during the second half of 2018, and delayed recognition of revenue in China due to the establishment of the company's new local subsidiary and supply chain.

The board said its expectations for 2019 remained unchanged, with “significant” opportunities for strong sales growth in the current financial year to December following exercise of the Tudorza option, and establishment of the direct sales operation in China.

In December 2018, the company announced that it had issued notice to exercise its option to acquire the full US commercial rights to Tudorza, which was completed as expected on 31 December.

Circassia said it anticipated the product's licence to transfer during 2019, following the FDA completing its review of the sNDA filing for the inclusion of additional data in the label, which was expected by 31 March.

Transfer of Tudorza to Circassia would allow the firm additional flexibility to manage the product's commercial and promotional priorities, the board said.

During the first half of 2019, Circassia also anticipated receiving the outcome of the filing for ‘Duaklir’ approval in the United States, which had a target date of 31 March, and to launch the product later in the year, assuming approval.

In preparation, Circassia said it was launching dedicated COPD and ‘NIOX’ promotional teams to improve targeting and efficiency and prepare for Duaklir launch.

A deferred Tudorza option payment of $20m would be payable upon approval of Duaklir, in addition to deferred consideration of $100m due under the companies' agreement.

Circassia said it anticipated satisfying the option payments and deferred consideration via third-party funding, or through a loan facility provided by AstraZeneca under the companies' agreement if that was unavailable.

The company said it also planned to roll out its “significantly expanded” sales force in China at the beginning of the year, where it intended to sell its NIOX products direct in the market, alongside existing distributors.

As a result, in 2019 it anticipated continuing its rapid transformation into a commercially-focussed specialty pharmaceutical business focused on respiratory.

“Circassia continued to make progress during 2018, and with our cost containment efforts showing results and revenues growing we look forward to continuing our trajectory towards self-sustainability,” said chief executive officer Steve Harris.

“We look forward to the coming year, as we roll out our expanded sales force in China and plan to take full control of Tudorza and launch Duaklir, once approved, in the United States.”