Sales of $314 million were up 5.6% reported and 11.5% on an underlying basis (excludes FX and
discontinued product lines). Sales were above our estimate of $311 million and Consensus of $309
million. FX had an unfavorable impact of $10 million on sales. EPS of $0.70 were in line with our
estimate and a penny above Consensus.
■ Total heart valve sales of $170 million were up 16.2% reported and 20.3% on an underlying basis.
Surgical heart valve sales were $146 million, up 8% operationally. US sales were up 6% as strong
valve sales offset declines in repair (Myxo/IMR repair products recalled in 4Q08). OUS sales were
up double-digits. Surgical valve sales are benefiting from new product launches and Edwards
believes it is gaining global market share.
■ Transcatheter valve sales of $24.6 million were above our estimate of $22.3 million and $18.5
million in 4Q08. Edwards increased its 2009 transcatheter valve sales guidance to “more than $100
million” from previous guidance of $75-$95 million. Approximately 850 valves were implanted in
Europe in 1Q09 and the transapical/transfemoral mix remains at about 2:1. The procedure success
rate remains at 95%.
■ US PARTNER enrollment is on track with over 850 patients enrolled to date and the company
continues to expect to complete enrollment in Cohort A in August. Edwards also announced that it
has received FDA approval for continued access to Cohort B (completed enrollment in March) under
the same protocol and randomization guidelines.
■ Critical care sales of $105 million were down 2.1% but up 1.7% operationally. Sales growth in
FloTrac and Precept were offset by negative growth in hardware sales ($3 million) due to hospital
capex constraints. Supplier issues in its hemofiltration business also negatively impacted sales by a
couple million, but is expected to improve in 2H09. We estimate capex sales are $20-$30M on an
annual basis (2% of sales). EW expects critical care sales to now be on the low end of guidance.
■ Cardiac surgery sales were $23 million, up 5.1% reported and 8.8% underlying. Strong MIS
disposable sales (up 20%+) offset slower sales of reusable instruments. Vascular sales were $16
million, down 2.5% operationally.
■ Adjusted gross margins were 69.1%, a significant increase of 380 bps year-over-year and 60 bps
sequentially helped by FX hedges and favorable product mix, offsetting manufacturing variances in
critical care. SG&A expense of 38.9% of sales were up slightly by 30 bps year-over-year and 70 bps
sequentially. R&D spend was 12.7% of sales.