Version 7
Fixes errors in Version 6
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BIOX 4th qtr projected P&L.
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AHP - USA Revenues of $5,000
No license fees -0-
Total Revenues $7,000
------
4th qtr E.P.S. $.10
------
Yr E.P.S $1.31
------
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1998 P&L
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1998 Comments
-------------------------------------------
BIOX looking at tough Synvisc launch window.
AHP Sales force receives Synvisc about Nov.15th.
Allowing 2 weeks for vacations,parties,etc.
this leaves 4 REAL WEEKS of selling time.
Consequently,
Q198 is real SELL-IN qtr. ($8,000)
Q298 is real SELL-THRU qtr. ($10,000)
By end Q298 we should have a handle on how
well Synvisc is accepted by marketplace.
Regards,
John McCarthy
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1998 Quarterly P&L and Assumptions
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Products/Status:
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FDA Approved - 8/13/97
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Sy3= Synvisc @35% of AHP Retail $-Osteoarthritis-Liquid prosthesis
Sy1= Synvisc @100% of AHP Retail $-Osteoarthritis-Liquid prosthesis
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FDA Expected Approval 12/31/97
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Hf = Hylaform -Facial Wrinkles-Hylan device
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NOT FDA APPROVED
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Hs = Hylashield -Eye drops -Protect Eyes
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Note:sold commercially in Canada/Italy
===========================================
Major P&L Assumptions:
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1998 Revenues from Synvisc (USA)
Distributor:American Home Products (AHP)
===========================================
Annual AHP @ Retail $135,000,000
Annual Price (2 Treatments/yr) 1,000
BIOX % of AHP .35
BIOX $ Gross Rev $47,250,000
Note:
1 treatment = 3 injections of Synvisc.
Cost of 1 treatment is est. @ $500.
1 treatment est. to last 6 months.
===========================================
Implied about AHP Sales Effort for 1998:
===========================================
Total Osteoarthritis Population 15,600,000
Total Target Patient Population 7,000,000
1998 Patients Treated 135,000
1998 (Target) % Treated 1.93%
-------------------------------------------------------------------
Biomatrix (BIOX) - 1998 1st 2nd 3rd 4th 1998
===================================================================
Pr Loc Dist
-------------------------------------------------------------------
Sy3 USA (AHP) 8,000 10,000 13,000 16,000 47,000
Sy3 NON-USA (AHP) 500 800 1,200 1,600 4,100
Sy3 France (Boe Ing) 350 350 350 350 1,400
Sy3 Canada (RPR) 450 450 450 450 1,800
Sy3 Sweden (Roche) 250 250 250 250 1,000
Sy3 Isr./FE (Bayer AG) 150 150 150 150 600
Sy3 Italy (Recdati) 75 75 75 75 300
Sy1 England (Biox) 50 100 200 200 550
Sy1 China (Biox) 25 50 100 100 275
Sy1 Norway (Biox) 1 1 1 1 4
Sy1 Finland (Biox) 1 1 1 1 4
Sy1 Switzer (Biox) 1 1 1 1 4
Hf USA (Collagen) 0 500 750 750 2,000
Hf NON-USA (Collagen) 500 500 500 500 2,000
Hs ITAL (Far Farm) 50 50 50 50 200
Other (Biox) 300 300 300 300 1,200
-------------------- ------- ------- ------- ------- -------
Total Product Sales 10,703 13,578 17,378 20,778 62,437
-------------------- ------- ------- ------- ------- -------
Memo:Seq. % N/A 27 28 20
Memo:Yr/Yr % 463 638 891 N/A
--------------------
Milestone Fees
--------------------
AHP 1,000 2,000 2,000 2,000 7,000
Boehringer Ingelheim 1,000 1,000 1,000 1,000 4,000
Bayer AG 0 0 1,000 1,000 2,000
-------------------- ------- ------- ------- ------- -------
Total Fees 2,000 3,000 4,000 4,000 13,000
-------------------- ------- ------- ------- ------- -------
Total Net Revenues 12,703 16,578 21,378 24,778 75,437
================== ====== ======= ======= ======= =======
Product GM (Avg. %) .65 .65 .65 .65 .65
Product GM $ 6,957 8,826 11,296 13,506 40,584
License GM $ 2,000 3,000 4,000 4,000 13,000
-------------------- ------- ------- ------- ------- -------
Total GM $ 8,957 11,826 15,296 17,506 53,584
=================== ======= ======= ======= ======= =======
--------------------
R & D
--------------------
Hylagel/Sur.Adhes/Ph1 600 625 650 675 2,550
Hylasine/EarNose/Ph1 550 575 600 625 2,350
Hylasol/Opth Sur/Ph1 200 225 250 275 950
Other 300 300 300 300 1,200
-------------------- ------- ------- ------- ------- -------
Total R&D 1,650 1,725 1,800 1,875 7,050
-------------------- ------- ------- ------- ------- -------
Memo:1997 (est.) 1,380 1,426 1,532 1,600 5,938
-------------------- ------- ------- ------- ------- -------
--------------------
SG&A
--------------------
Normal 2,200 2,300 2,400 2,500 9,400
Sy England (Biox) 350 300 250 200 1,100
Sy China (Biox) 350 300 250 200 1,100
-------------------- ------- ------- ------- ------- -------
Total SG&A 2,900 2,900 2,900 2,900 11,600
-------------------- ------- ------- ------- ------- -------
Memo:1997 (est.) 1,409 1,883 1,969 2,150 7,411
-------------------- ------- ------- ------- ------- -------
-------------------- ------- ------- ------- ------- -------
Total R&D/SG&A 4,550 4,625 4,700 4,775 18,650
-------------------- ------- ------- ------- ------- -------
-------------------- ------- ------- ------- ------- -------
Inc. from Operations 4,407 7,201 10,596 12,731 34,934
-------------------- ------- ------- ------- ------- -------
Int.Income- Net (4%) 235 267 320 396 1,218
-------------------- ------- ------- ------- ------- -------
EBT 4,642 7,468 10,915 13,127 36,152
-------------------- ------- ------- ------- ------- -------
Tax Prov. (%) .30 .30 .30 .30 .30
Tax Prov. ($) 1,393 2,240 3,275 3,938 10,846
-------------------- ------- ------- ------- ------- -------
EAT 3,249 5,228 7,641 9,189 25,307
================== ======= ======= ======= ======= =======
Cash/Mrt.Sec-BOP 23,500 26,749 31,977 39,618 -
================== ======= ======= ======= ======= =======
Shares Outstanding 11,900 11,900 11,900 11,900 11,900
================== ======= ======= ======= ======= =======
E.P.S .27 .44 .64 .77 2.13
================== ======= ======= ======= ======= =======
@ PE / Share Price
-------------------- ------- ------- ------- ------- -------
20 42.00
-------------------- ------- ------- ------- ------- -------
25 53.00
-------------------- ------- ------- ------- ------- -------
30 64.00
-------------------- ------- ------- ------- ------- -------
35 74.00
-------------------- ------- ------- ------- ------- -------
40 85.00
-------------------- ------- ------- ------- ------- -------
45 95.00
-------------------- ------- ------- ------- ------- -------
50 106.00
-------------------- ------- ------- ------- ------- -------
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Notes:
===========================================
A.Amendment 5/29/97 increase auth. shares
===========================================
TO 60,000,000
FROM 20,000,000.
Don't know if ratified.
===========================================
B.Ownership 3/1/97
===========================================
Endre A. Balazs 2,161,519 20%
Janet I. Denlinger 1,099,085 10%
H. Stuart Campbell 61,248
Rory B. Riggs 600,000 6%
Others 54,000
Shares Outstanding 6/30/97 11,158,098
===========================================
C. Distribution Agreements
===========================================
Boehringer Ingelheim - 12/18/96
===========================================
Fee:$8.0 million
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Countries:
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France,Algeria,Morocco
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Req. Biomedical Specialists:5
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Estimated License Payment Schedule
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1996 -0-
1997 -0-
1998 4
1999 4
===========================================
Wyeth-Ayerst (AHP) - 2/10/97
===========================================
Fee:$23.0 million
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Countries:
-------------------------------------------
USA
Germany,Austria,Greece,Spain,Portuagal
Poland,Hungry,Romania,Bulgaria,Check
Turkey,Saudi Arabia,Egypt,Syria,Jordan
Req. Biomedical Specialists:Yes(# unknown)
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Estimated License Payment Schedule
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1996 -0-
1997 16
1998 7
1999 -0-
===========================================
Bayer AG - 4/29/97
===========================================
Fee:$5.0 million
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Countries:
-------------------------------------------
Israel,Australia,New Zeland,Taiwan,Singapore
Indonesia,Thailand,Maylaysia
Req. Biomedical Specialists:2
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Estimated License Payment Schedule
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1996 -0-
1997 3
1998 2
1999 -0-
===========================================
Synvisc Competitors
===========================================
ANIK - OrthoVisc -
===========================================
In Phase 3 - PMA expected Dec 97.
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OrthoVisc currently for sale in:
Europe - Turkey - Canada
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Just signed a deal with Distributor
for Spain and Portuagal:
Grupo Ferrer Internacional, S.A.,
a leading pharmaceutical company based in Spain,
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Coming out with a secondary
offering sometime in Dec 97/early 98
3,000,000 shares
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Need distributor for USA - MAYBE BAYER (???JGM)
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More info?
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Contact:Edurado on the ANIK thread
Note:He is *very* smart. (JM)
===========================================
ANIK - OrthoVisc - advantage over Synvisc
===========================================
Post #25 from ANIK - by Eduardo Canto
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The advantage of Orthovisc will be (as long as the ph III proves
us right) the lack of immune reaction against the product.
Healon which is natural HA like Orthovisc
had an adverse reaction rate of 1% per injection
compared to 2.7% for Synvisc,
at three injections Synvisc
had an adverse reaction rate of 7% per knee.
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Following:
-------------------------------------------
Anika is followed by two analalysts at
Cruttenden Roth:
William R. Prather M.D. &
Jeffrey Schottler
at (303) 595-3377
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===========================================
Sanofi/Orthologic
===========================================
In Europe already.
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In USA:Post 19 on ANIK thread
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In addition to Synvisc, the only other
licensed HA product in the US is Hyalgan
(marketed by Sanofi and Orthologic under
license from an Italian Company called Fidia).
Being a natural HA product already in
use for eye surgery, Orhtovisc has a
lower risk of allergic reaction which have been
noted in people treated with Synvisc which has
crosslinked HA not found in nature.
Don't know when it is coming to USA
but it is coming.
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More info?
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Contact:Edurado on the ANIK thread
===========================================
Biomatrix - Hylaform Product
===========================================
Sold by Collegen
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From Collagen 10Q - Sept 97
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June 1996, Company entered a
distribution ("Biomatrix") ... Hylaform(R) ...
paid
$5.0 million ...
for rights ...
outside United States
and option to purchase
the United States distribution rights
in future...
Company launched
Hylaform gel
in international markets fiscal 1997.
Company required to pay a
transfer price
for Hylaform gel shipments,
as well as
royalty
on all
of Company's facial injectable product sales
in countries
where Hylaform gel is sold.
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Collagen 10K - Sept 97
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Hyaluronan
plays role
skin's hydration and viscoelasticity.
Over time, hyaluronan in skin decreases,
contributing to aging appearance of skin.
Due to unique cross-linking to
hylan B,
Hylaform gel has
a higher water content and greater elastic properties
than
other hyaluronan-derived products.
hyaluronan neither tissue-specific
nor species-specific,
can be used
without
a skin test.
Hylaform gel has a
chemical structure
completely different
from
bovine collagen
and
not contain bovine protein.
Hylaform gel
allows same day treatment
of facial wrinkles and scars,
giving patients and doctors
an additional treatment option.
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COMPETITION.
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Company is aware
of one company in Europe
markets a hylauronic acid-based product called
Restylane
competitive
with Hylaform gel. |
