Back in January, medical device maker Kensey Nash
Oops, it did it again.
After the bell on Wednesday, Kensey Nash once again lowered guidance -- in part (again) because of delays in obtaining approval from the Food and Drug Administration for TriActiv, which will initially be marketed for treating blockages in grafts using the saphenous vein, a leg vein that's used for bypasses. Instead of the $16 million or so in revenue that it told us to expect for the March quarter, the number now looks to be somewhere in the mid-$14 million range.
Full-year revenue guidance (the company's fiscal year ends in June) also got clipped by about 8%-10%, and earnings for the year are now seen at coming in around $1.09 per share instead of $1.19.
Lower guidance tied to a delayed FDA approval isn't too bad (or surprising), but the company also took down its estimates for biomaterial sales -- to the tune of $500,000 in the March quarter and $2 million in the June quarter.
Although management believes these reductions are just "timing issues" with end-user Orthovita
None of this is to say that the news from the conference call was all bad.
Even though Kensey Nash's stock got hit hard earlier in the week on fears that the FDA was going to reject approval of the TriActiv device, management indicated that approval is still on track. The company now seems to be hammering out some final labeling and data discussions with the FDA and believes that approval could come within 30 days.
At the risk of stating the obvious, that's a good thing. The TriActiv System addresses a $150 million-plus market opportunity and represents the company's first solely controlled product offering.
Investors should also note that while the company lowered its fiscal 2006 guidance in absolute terms, the implied growth rate between 2005 and 2006 remained basically the same, at around 25%.
With the stock taking a big hit lately, is it a value? Eh, kinda. Sorta.
The company's forward price-to-earnings ratio of about 25 and price-to-sales number of about 5 aren't unreasonable for a growing med-tech firm. And despite some recent disappointments, the company does still appear to be growing. What's more, if the company hits the 25% growth target in fiscal 2006, then the forward P/E-to-growth ratio is a nice 1-ish number.
Although analysts' forward estimates will likely be declining for the fourth time in the past three months (seldom a good sign), it would be dangerous to completely ignore what TriActiv could mean to Kensey Nash when, or if, TriActiv gets FDA approval. After all, it's not every day that a company with $300 million in market cap gains entry into a $150 million-potential market.
Tom Gardner recommended Kensey Nash in the May 2003 issue of Motley Fool Stock Advisor . Since then, shares are up 48.02% vs. the S&P's 37.27% return. To find out which other stocks have made the cut, subscribe today with a six-month money-back guarantee.
For more on the Foolish world of med-tech:
- The Stent Wars Continue
- Kyphon Developing a Backbone
- Cytyc Grows but Stays Focused
- Kensey's Guidance Falls Just Short
Fool contributor Stephen Simpson has no financial interest in any stocks mentioned (that means he's neither long nor short the shares).