RRR schreef op 11 maart 2016 10:20:
Solid start to Ruconest in US
Pharming's 2015 results demonstrated a good first year performance for Ruconest in the US. We estimate US
sales of Ruconest were c.$24m following launch there in late 2014. With significant investment in R&D,
Pharming's net loss for the year was €10m (Stifel est. €9.6m), as the company invested in further indications
and a subcutaneous formulation for Ruconest, as well as its pipeline. We continue to believe Ruconest's
positioning as a safe and effective alternative to Shire's market-leading products should allow it to gain share
in the growing HAE market. In our view, Pharming remains undervalued in light of this potential. Buy.
Ruconest remains key. Revenues from Ruconest sales grew to €8.6m (vs
€3.0m in 2014), aided by the first full year sales in the US, but marginally
below our expectations. EBIT (excluding milestones) improved to a loss of
€12.8m vs €13.1m, net loss of €10m was in line with our expectations, and
cash was marginally better than expected at €31.8m (vs €34.4m at the end of
2014). We have reduced our near-term Ruconest sales to account for the
slower uptake in the US, but continue to forecast $335m sales at peak, given
the potential for it to be approved for prophylactic use, and the development of
a subcutaneous version. To date, Ruconest has demonstrated successful
results in patients where other treatments have not worked.
Full year of Ruconest sales in the US, expanding elsewhere. Ruconest
sales continued to grow well in 2015, with Pharming receiving income of
€6.3m in the US (up from €0.3m in 2014), and sales in Europe and RoW of
€2.3m, representing an underlying increase of 9% in market sales. Growth in
the US was slower than expected (having also been hampered by Valeant’s
acquisition of Salix), although prescriptions have continued to grow. In Europe
the requirement to test for rabbit allergies prior to first use has been removed,
and the label has been extended to include adolescent patients. Pharming has
also extended its agreement with Cytobioteck in Latin America, having
achieved the first sales in Colombia and Venezuela, and Ruconest has been
approved in South Korea.
Topline data from prophylaxis trial results due 2Q16. Pharming has
completed recruitment of the Phase II clinical trial in prophylaxis of HAE, with
topline data expected in mid-2016. Approval of Ruconest in the prophylaxis of
HAE will allow Ruconest to be used across the entire spectrum of HAE
patients and should provide a boost to sales. Pharming then intends to outline
a development pathway for US prophylaxis approval, likely to involve a Phase
III trial, where it will also look to test the subcutaneous version of Ruconest
alongside.
Solid base built to support growing momentum. We believe Ruconest
sales growth is likely to continue in further territories, and the Phase II trial
results in prophylaxis (expected 2Q16) provides a near-term inflection point.
Pharming also expects to announce an update on its pipeline development in
2Q16. We believe the company is well placed to continue growing revenues,
and that Ruconest’s offering as a safe, efficacious alternative to Shire’s
market-leading products should allow it to continue gradually increasing
market share.
BUY :-)