Ci-joint analyse de KBC securities: objectif de cours 1 €
Tigenix reported in its FY13 report financials which were as expected. With a strengthened balance sheet, pipeline projects can now be pushed forward. We up our target price to € 1/sh and rating to Accumulate.
Our View:
FY13 ChondroCelect (CC) sales arrived at € 4.3m, +25% y/y, in line with our expectations. 4Q13 CC sales was € 1.2m, up 38% y/y and compensated for the weak 3Q13 result of € 0.8m. Sales is still driven by Belgian and Dutch patients, but the hope is that in 2014 patients from Spain and the UK should contribute to the growth. Tigenix reiterates its ambition to make CC a cash flow positive franchise in 2014.
Operating expenses decreased by 7% to € 21m following lower R&D costs (€ 11m, -18%), flattish G&A costs of € 6m, offset by higher sales&marketing costs (€ 3.4m, +19% y/y). The net loss of the year was € 18m vs. € 20m in FY12. Discontinued operations (the Dutch manufacturing plant) booked € 2m loss.
Thanks to the two private placements totalling € 18.4m and € 2.7m of non- dilutive government support, Tigenix’ cash position landed at FY13 at € 16m. The average monthly cash burn in 2013was € 1.1m.
Tigenix’ adipose cell-based product pipeline is being pushed forward. The phase III Cx601 fistula trial is confirmed to be on track to recruit all patients in 2014 with final results now expected by 3Q15. The company held in December an end-of-phase II meeting with the US FDA to discuss a path forward testing the product in US patients. Following the outcome of this meeting, Tigenix has initiated the technology transfer to a US contract manufacturing organization and plans an application for a so-called Special Protocol Assessment which – if approved - should allow the company to request for the initiation of a US phase III study in 2015. Moreover, Tigenix said it is re-opening partnering discussions for Cx601 in other regions.
On Cx611, the cell based product that reported phase II results in 1H13, Tigenix is designing follow-up studies in inflammatory and autoimmune diseases which it expects to finalise and communicate on in the coming weeks.
We remind that in January of this year, Tigenix secured a € 10m loan with Kreos Capital (term to be approved at the EGM of 2 April 2014) and expects to receive € 3.5m cash from the sale of its Dutch plant to PharmaCell. These cash resources should allow the company to finance its product pipeline until the next development milestone in 2015 is met.
Conclusion:
Tigenix has left the financial danger zone and progress in its ChondroCelect franchise and product pipeline should be the focus of the value creation. We up our target to € 1/sh and rating to Accumulate (from € 0.65 and Hold).