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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?


To: Wally Mastroly who wrote (3521)12/13/1999 4:00:00 PM
From: Sir Auric Goldfinger  Read Replies (1) | Respond to of 4140
 
LEHM musta been long a few too many: Lehman Brothers (David A. Gruber, M.D. (212)526-192) SNRS
Sunrise Technologies Intl. Inc: Initiating Coverage With A 1-Buy Rating

Ticker : SNRS Rank(Old): 9-Not Rated Rank(New): 1-Buy Rated
Price : $10 1/8 52wk Range: $21 - 2 Price Target (Old): $0
Today's Date : 12/13/99 Price Target (New): $15
Fiscal Year : DEC
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EPS 1998 1999E 2000E 2001E
QTR. Actual Old New Old New Old New
1st: (.11) - (.21)A - (.12)E - (.01)E
2nd: (.17) - (.14)A - (.09)E - .00 E
3rd: (.10) - (.13)A - (.06)E - .02 E
4th: (.14) - (.13)E - (.03)E - .05 E
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Year:$ (.52) $ - $(.60)E $ - $(.29)E $ - $.06 E
Street Est.: $ - $ - $ - $ - $ - $ -
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Price (as of 12/10): $10 1/8 Revenue (1999E): $0.0 Mil.
Return On Equity (99): N/A Proj. 5yr EPS Grth: N/A
Shares Outstanding: 45.7 Mil. Dividend Yield: - -
Mkt Capitalization: $462.7 Mil. P/E 2000; 2001 : N/A; 169x
Current Book Value: $0.13/sh Convertible: +
Debt-to-Capital: 0 Disclosure(s): None
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BACKGROUND:
Sunrise Technologies Intl. Inc, develops, manufactures and markets laser
systems for applications in ophthalmology. All efforts are focused on the
engineering and development of a holmium laser corneal shaping product
(Hyperion) utilizing the process known as Laser Thermal Keratoplasty (LTK),
for the treatment of refractive errors of the eye, such as hyperopia
(farsightedness) and presbyopia (age-related loss of near focusing ability).

HIGHLIGHTS:

* INVESTMENT POSITIVES:
* Untapped hyperopia market
* Ease-of-use features makes LTK adoption appealing to all ophthalmologists
* Favorable economics
* Off label procedures
* Immediate adoption by Excimer Laser LASIK Centers
* INVESTMENT RISKS:
* Failure to obtain FDA Panel recommendation for approval
* Restrictive labeling
* Market acceptance of holmium lasers for hyperopia
* Manufacturing capacity

INVESTMENT CONCLUSION: Here comes the Sun(rise)!
Hyperopia (far-sightedness) remains an unmet need; LASIK penetration of this
indication is minimal. Sunrise' holmium laser offers physicians an easy-to-
use, in-office procedure with good clinical outcomes. FDA Panel review is
scheduled for January 13, and represents a primary risk. We expect panel
recommendation for approval of the revised labeling request; i.e., reduction
(rather than correction) of hyperopia. Our price target of $15 reflects a
price-to-sales multiple of 11x our 2001E sales estimate of $69m.

Investment Positives:

UNTAPPED HYPEROPIA MARKET.
Approximately 82 million Americans are hyperopic (far-sighted). Hyperopia,
unlike myopia usually first manifests in adulthood with nearly two-thirds of
far sighted patients over 40 years old. Hyperopic LASIK has not been widely
accepted due to (a) increased procedural complexity relative to myopia (b)
the need for over-correction due to the potential for regression (c) more
demanding patients with comparatively high expectations for visual acuity,
and (d) a lesser immediate inclination for cosmesis. We believe holmium laser
LTK offers a "better" solution to mild-moderate grade hyperopia ( +.75 to
+2.5 diopters) than LASIK.
EASE-OF-USE FEATURES MAKES LTK ADOPTION APPEALING TO ALL OPHTHALMOLOGISTS
(NOT JUST REFRACTIVE SURGEONS)
The training requirement for holmium LTK is minimal; this contrasts with
excimer laser LASIK, which require a highly skilled refractive surgeon.
Operation of the equipment requires the "press of a button". It is that
simple! No cutting of the cornea! In addition, holmium lasers do not require
any "special" site requirements making LTK an in-office procedure. (Note:
excimer lasers require a special room with independent temperature and
humidity controls, as well as dedicated 220V electric service). There are
15,000 potential customers (ophthalmologists in the U.S.) for Sunrise holmium
lasers as compared to 3,500 (ophthalmologists who perform refractive surgery)
for LASIK.
FAVORABLE ECONOMICS
Until the advent of LASIK, ophthalmologists had diminishing expectations
towards future income streams. Declining HMO payment schedules and HCFA
reimbursement had been "grudgingly" accepted by MDs. Laser Vision Correction
surgery, a non-insurance-reimbursable procedure, is akin to plastic surgery
in terms of unfettered, unregulated revenue generation. Patients tend to be
from higher socio-economic classes. Physician fees for LTK are expected to be
somewhat less than that for LASIK, but still highly profitable for the
ophthalmologist.
OFF LABEL PROCEDURES
Although the FDA is only considering approval for the reduction of mild to
moderate hyperopia, we believe the community of refractive surgeons will use
the Sunrise Hyperion holmium laser to fix "over-corrected" myopic LASIK
patients and hyperopic LASIK patients who have regressed towards hyperopia
again. Presently, more than 8.5% of patients undergoing myopic laser (70,000
eyes in 1999E) need some further surgical intervention in order to refine the
final visual acuity. For the patients who require increased corneal power,
LTK is infinitely easier and faster to perform than LASIK.
IMMEDIATE ADOPTION BY EXCIMER LASER LASIK CENTERS
We anticipate that many Excimer Laser Vision centers operating today will
want to purchase the Sunrise Hyperion for two important reasons. As
mentioned, LTK will be a faster and more efficient means of fixing
overcorrected patients without subjecting them to more "surgery" and the
inherent complications of re-lifting a LASIK corneal flap. Second, and
equally important, is the desire to differentiate themselves in the minds of
their customers as a full service Vision Correction facility.

Risks:
FAILURE TO OBTAIN FDA PANEL RECOMMENDATION FOR APPROVAL.
On July 22, 1999, the Sunrise LTK technology was rejected for approval by an
FDA Advisory panel based on the perception that the rate of continuing
regression of therapeutic effect was too great. Although the panel
complimented Sunrise for the excellence of their study design and superb
safety profile, it feared that some patients with small corrections would
lose the effect of the surgery and revert to hyperopia. The company was
asked to submit two years of post operative data in order to show that the
rate of regression slowed at 24 months to a point that is clinically
insignificant. The FDA has once again sent Sunrise to a panel hearing to be
held on January 13, 2000. Sunrise has changed their request for labeling to
read "for the reduction of hyperopia," not "for the correction of hyperopia."
We expect that the FDA will approve the LTK technology by Q2 00.
RESTRICTIVE LABELING
We anticipate FDA approval for hyperopic patients, > 40 years old, with mild
to moderate refractive error encompassing +0.75 to +2.5 diopters. We believe
these patients account for at least 50% of the eligible hyperopic population.
Approval for the Hyperion will be based on data obtained with the Sun 1000,
its predecessor. A broader range of product approvals is expected within 9-12
months.
MARKET ACCEPTANCE OF HOLMIUM LASERS FOR HYPEROPIA
In the early 1990's, holmium lasers were found to be unsatisfactory for the
treatment of hyperopia. The amount of regression following ablation was
excessive. This history may create a negative bias against the technology. In
addition, LASIK competitors might "bad mouth" the technology based on
historical rather than current clinical data. We believe regression
associated with holmium lasers is no more significant than that of LASIK
(while providing a greater safety profile). Market development will also be
required.
MANUFACTURING CAPACITY
Many of the components necessary for assembly of the Hyperion are sourced
from contract manufacturers. A subcontractor assembles a sub-assembly, which
is then shipped to Sunrise for integration with optics and a Sunrise
manufactured holmium laser. Critical components with lead times of 3-6 months
have been ordered. The Hyperion has not yet been assembled in production
quantity. Approximately 5 units are in the final stages of testing. FDA
plant inspection will follow Advisory Panel recommendations.

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BUSINESS DESCRIPTION: Sunrise Technologies International, Inc. develops,
manufactures and markets laser systems for applications in ophthalmology.
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Disclosure Legend: A-Lehman Brothers Inc. managed or co-managed within the
past three years a public offering of securities for this company. B-An
employee of Lehman Brothers Inc. is a director of this company. C-Lehman
Brothers Inc. makes a market in the securities of this company. G-The Lehman
Brothers analyst who covers this company also has position in its securities.

This document is for information purposes only. We do not represent that this
information is complete or accurate. All opinions are subject to change. The
securities mentioned may not be eligible for sale in some states or
countries. This document has been prepared by Lehman Brothers Inc., Members
SIPC, on behalf of Lehman Brothers International (Europe), which is regulated



To: Wally Mastroly who wrote (3521)12/13/1999 7:03:00 PM
From: Stephen M. DeMoss  Respond to of 4140
 
Looks like an analysist wants to get on BEFORE the big move!
I am encouraged. Nice move in the stock too! Soon the shorts will need to play their role<G>! Steve d.