SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE TO

(Rule 14d-100)

Tender Offer Statement Under Section 14(d)(1) or Section 13(e)(1)

of the Securities Exchange Act of 1934

 

 

BIOFORM MEDICAL, INC.

(Name of Subject Company (Issuer))

VINE ACQUISITION CORP. (OFFEROR)

MERZ GMBH & CO. KGAA. (PARENT OF OFFEROR)

(Names of Filing Persons)

 

 

COMMON STOCK, $0.01 PAR VALUE PER SHARE

(Title of Class of Securities)

09065G 107

(CUSIP Number of Class of Securities)

 

 

Matthias Vogt

Member of the Management Board and Chief Financial Officer

Merz GmbH & Co. KGaA

Eckenheimer Landstrasse 100

Frankfurt am Main 60318

Germany

+49 69-1503-0

(Name, address and telephone number of person authorized to receive notices

and communications on behalf of filing persons)

 

 

With a copy to:

Keith A. Flaum, Esq.

Lorenzo Borgogni, Esq.

Dewey & LeBoeuf LLP

1950 University Avenue, Suite 500

East Palo Alto, California 92612

(650) 845-7000

 

 

CALCULATION OF FILING FEE

 

Transaction Valuation*: N/A    Amount of Filing Fee*: N/A

 

* A filing fee is not required in connection with this filing as it relates solely to preliminary communications made before the commencement of a tender offer.

 

¨ Check the box if any part of the fee is offset as provided by Rule 0-11(a)(2) and identify the filing with which the offsetting fee was previously paid. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.

 

x Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.

 

Amount previously paid: $ N/A    Form or registration no.: N/A
Filing Party: N/A    Date Filed: N/A

 

 

 

x third-party tender offer subject to Rule 14d-1.

 

¨ issuer tender offer subject to Rule 13e-4.

 

¨ going-private transaction subject to Rule 13e-3.

 

¨ amendment to Schedule 13D under Rule 13d-2.

Check the appropriate boxes below to designate any transactions to which the statement relates:

Check the following box if the filing is a final amendment reporting the results of the tender offer:   ¨

 

 

 


This filing on Schedule TO relates to a planned tender offer by Vine Acquisition Corp. (“Acquisition Sub”), a Delaware corporation and an indirect wholly-owned subsidiary of Merz GmbH & Co. KGaA (“Merz”), to purchase all of the outstanding shares of common stock, $0.01 par value per share, of BioForm Medical, Inc. (“BioForm Medical”), a Delaware corporation, to be commenced pursuant to an Agreement and Plan of Merger, dated as of December 31, 2009, by and among Merz, Acquisition Sub and BioForm Medical. Attached hereto is a copy of the slides accompanying a presentation given by Merz on January 11, 2010.

Forward-Looking Statements

This document contains forward-looking statements, including those relating to Merz’s anticipated acquisition of BioForm Medical and expected benefits of the transaction, such as the introduction of new products and products under development, or the timing thereof, the ability to obtain, and the timing of, future U.S. regulatory clearances and approvals, including for Polidocanol and Bocouture®/XEOMIN® neurotoxin, the potential for future growth in Merz’s worldwide aesthetics and dermatological business, the impact that the acquisition would have on Merz’s competitive positioning and future growth in its worldwide aesthetics and dermatological business, and the growth in the aesthetic market, generally. Forward-looking statements may contain words such as “expect,” “believe,” “may,” “can,” “should,” “will,” “forecast,” “anticipate” or similar expressions, and include the assumptions that underlie such statements. These statements are subject to known and unknown risks and uncertainties that could cause actual results to differ, even materially, from those stated or implied, including but not limited to: the risk that the transaction will not be consummated in a timely manner or at all if, among other things, fewer than a majority of the shares of BioForm Medical common stock are tendered, clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, is not obtained, or other closing conditions are not satisfied; the successful integration and performance of the acquired business; unknown, underestimated or undisclosed commitments or liabilities; the effectiveness of internal controls; Merz’s ability to: (i) realize synergies expected to result from the acquisition; (ii) successfully commercialize purchased products; (iii) develop, deliver and support a broad range of products, expand its markets, and develop new markets; (iv) attract, motivate and retain key employees; and (v) obtain and protect intellectual property rights in key technologies; and other risks described in BioForm Medical’s filings with the U.S. Securities and Exchange Commission (the “SEC”). All forward-looking statements are based on managements’ estimates, projections and assumptions as of the date hereof and are subject to risks and uncertainties, which may cause actual results to differ, even materially, from the statements contained herein. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Neither Merz nor BioForm Medical undertake any obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.

Additional Information and Where to Find It

The tender offer described herein has not commenced. This announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of BioForm Medical. At the time the tender offer is commenced, Merz and its acquisition subsidiary will file with the SEC a Tender Offer Statement on Schedule TO with the SEC, and BioForm Medical will file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer.

The tender offer will be made solely by the Tender Offer Statement. Holders of shares of BioForm Medical common stock are urged to read the Tender Offer Statement (including the Offer to Purchase, related Letter of Transmittal and all other offer documents) and the Solicitation/Recommendation Statement when they become available, because they will contain important information that holders of shares of BioForm Medical common stock should consider before making any decision regarding tendering their securities.

Stockholders of BioForm Medical will be able to obtain free copies of the Tender Offer Statement, the Tender Offer Solicitation/Recommendation Statement and other documents filed with the SEC by Merz and BioForm Medical through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of these documents by contacting the Investor Relations department of BioForm Medical at 650-286-4003 or by mailing a request to the information agent for the tender offer, MacKenzie Partners, Inc., 105 Madison Avenue, New York, New York 10016; by calling toll free at 1-800-322-2885 or call collect 212-929-5500; and at tenderoffer@mackenziepartners.com.


Merz Pharmaceuticals
Company Introduction
JP Morgan Conference, January 11, 2010


2
|  Page
This
presentation
contains
forward-looking
statements,
including
those
relating
to
Merz’s
anticipated
acquisition
of BioForm
Medical and expected benefits of the transaction.
Forward-looking
statements
are
based
on
managements’
estimates,
projections
and
assumptions
as
of
the
date
of
this
presentation
and
are
therefore
subject
to
risks
and
uncertainties
--
including
but
not
limited
to:
the
risk
that
the
transaction
will
not be
consummated
in
a
timely
manner
or
at
all;
and
other
risks
described
in
BioForm
Medical’s
filings
with
the
U.S.
Securities
and
Exchange
Commission
--
which
may
cause
actual
results
to
differ,
even
materially,
from
the
statements contained
in
this presentation.
Neither Merz
nor BioForm
Medical undertakes any obligation to update publicly any of these forward-looking  
statements.
Forward Looking Statements


3
|  Page
Information Concerning the Tender Offer
The tender offer described in this presentation has not yet commenced, and this presentation is for
informational purposes only and is neither an offer to purchase nor  a solicitation of an offer to sell shares of
BioForm
Medical.
The
tender
offer
will
be
made
solely
by
a
Tender
Offer
Statement
on
Schedule
TO,
which
will
be
filed
with
the
SEC
by
Merz
and its acquisition subsidiary.
BioForm
stockholders are urged to read the Tender Offer
Statement,
as
well
as
the
Solicitation/Recommendation
Statement
on
Schedule
14D-9
to
be
filed
with
the
SEC by BioForm
Medical, when they become available, because they will contain important information that
BioForm
stockholders should consider before making any decision regarding tendering their shares.
BioForm
stockholders will be able to obtain free copies of the Tender Offer Statement, the Solicitation/
Recommendation
Statement
and
other
documents
filed
with
the
SEC
by
Merz
and
BioForm
Medical,
through the
web
site
maintained
by
the
SEC
at
www.sec.gov
or
by
contacting
the
Investor
Relations
department
of BioForm
Medical
or
the
information
agent
for
the
tender
offer,
MacKenzie
Partners,
at
1-800-322-2885
or
collect
at
212-929-5500.


4
|  Page
4
Merz Pharma: Germany’s fifth largest R&D driven pharma
company (fiscal year 2008 / 2009 figures)…
Note: 2009 figures
Source: Merz
Subsidaries
Headquarters
Frankfurt/M., Germany
Family-owned
~1,745 Pharma employees
world-wide (+ 7,8%)
Pharma sales
€590M (+ 8%)


5
|  Page
5
with strong research and franchises
Note: 2009 figures
Source: Merz
Memantine
(Namenda)
Mederma®
Xeomin®
Alzheimer's
Disease
Scar / Hair
treatment
Neurology
Dermatology
Dystonia/
Spasticity
Aesthetic
franchise
#2 global
Rx drug
First company to
market pure
Botulinum toxin
#1 in US


6
|  Page
6
1
MS = Value market share
Note: Daiichi Asubio
to be launched in 2011 //Source: Merz; IMS
Strong partnerships (Forest / Lundbeck
/ Daiichi Sankyo)
lead to number 2 position worldwide, Memantine
with
continued double digit growth ww
in Q1 2009 / 2010
0.3 (~12%)
2003 / 2004
1.5 (~22%)
Memantine sales
world-wide in $bn
(MS
1
)
2008 / 2009
1.0
0.5
Merz (Axura®)
in cooperation
with
Forest
(Namenda®) &
Lundbeck
(Ebixa®)
58% CAGR
1.5


7
|  Page
7
Source: Merz annual report 2008 / 2009
US fastest growing major region and largest market for Merz
(Sales
Merz
Pharma
Group
2008/09
by
region)
Germany: €
187,8 m (+ 6%)
Rest of Europe: €
164,4  m (+ 6%)
USA: €
220,8 m (+ 11%)
Other
regions: €
16,8 m (+ 13%)
589,8 million: growth 8%


8
|  Page
Solid financial performance provides strength for R&D, 
licensing & M&A (all figures in €
M)
477,5
546,5
589,8
185,4
221,8
267,9
0
100
200
300
400
500
600
700
2006/07
2007/08
2008/09
Net revenues
EBIT before R&D
R&D
2006/07
2007/08
2008/09
EBIT-Margin before R&D
38,8%
40,6%
45,4%
R&D
60,1
87,1
132,0
R&D in % of Net revenues
12,6%
15,9%
22,4%
Investment in assets
24,5
28,3
26,8
Cash development
119,5
128,3
196,6
M


9
|  Page
We target highly attractive market segments…
Specialty CNS /
Movement Disorders
Aesthetic Medicine
Tinnitus
Market size: $5 bln+
Growth: >10%
Market size: $2 bln+
Growth: >10%
Market size: $1 bln+
Growth: N/A
Alzheimers
Market size: $5 bln+
Growth: >10%
Key considerations:
High unmet medical
need
Aging population
High R&D risk
Key considerations:
Unmet medical need
Niche market 
Spasticity market not
exploited
Key considerations:
self paid
new treatment
options
market with growth
potential
Key considerations:
High unmet medical
need
5% of population
affected
Potential market
shaper
Strategy to establish own presence and sales force only in specialty markets


10
|  Page
that allow us to obtain a prominent market position
Merz today
Memantine: global #2
Attractive early stage pipeline
Xeomin: global roll out of the next
generation Neurotoxin
Attractive injectable
portfolio under global
role out
Global commercial position under build up
Only effective treatment for tinnitus 
(Phase III trials ongoing)
A leading specialty niche CNS
Top 3 global player in Aesthetics
Neramexane
established as the first in
category treatment for Tinnitus 
Attractive Ear disease pipeline
Merz aspiration
Specialty
CNS
Aesth.
Med.
ENT


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|  Page
Specialty CNS


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|  Page
We
have
established
an attractive
CNS pipeline…..
Phase II
Phase III
Phase I
Subm.
Memantine
Botulinum
Neurotoxin
Typ
A
Neramexane
CNS
Phase 0
Filing
Tinnitus
Nystagmus
Merz Pharmaceuticals
Alzheimer-
Dementia
Parkinson
MRZ 99030
MRZ 8456
Spasticity (EU)
Blepharospasm
/ Torticollis
spasmodicus
(US)           
Moderate to severe Alzheimer dementia (Japan)


13
|  Page
…and with
Xeomin
®
/ Bocouture
®
the
next
generation
Botulinum
Neurotoxin
Type
A
under
global
roll
out
NT201
Unique
features:
free
of complexing
proteins
low potential for antibody
formation
stable without
refrigeration
established efficacy and
safety


14
|  Page
Merz Aesthetics


15
|  Page
Our Vision:
to become one of the
world’s most admired
aesthetics brands
Belotero
®1
Novabel
®
Bocouture
®
/ Xeomin
®
We are under global roll out of a competitive range of
products to fulfill physician’s and patient needs…
1
licensed
only
in selected
territories


16
|  Page
and just launched with Novabel
®
based on Geleon
TM 
technology a new class of fillers in Europe
The versatile shaper ,
gentle
and powerful
Novabel
150µm
30
Erythrocytes
7,5
µm
Thrombocytes
1,5µm-3,0 µm
Adipocytes
70-120µm
Memory shape effect: even after
passing narrow tissue structures
„Geleons“
are able to recapture their
original perfect round shape


17
|  Page
Our way forward in growing our Aesthetics operations
Expand global presence by acquisition of BioForm Medical
Emphasize own development efforts and address unmet needs
Seek portfolio acquisition and licensing opportunities to further build our global
presence & network


18
|  Page
Merz +  BioForm Medical:
Strengthening our foundation in Aesthetics
Expands product offering with additional innovative, quality aesthetics treatment options
Able to offer dermal fillers based on three distinct technologies
RADIESSE ®
hydroxylapatite
filler
Belotero ® ,
hyaluronic
acid
filler
(under
development
for
the
US)
Novabel® ,
biocompatible
brown
algae
filler
(under
development
for
the
US)
Innovative
aesthetics
products
(under
development
for
the
US
market)
Polidocanol ,
a
sclerotherapy
agent
Bocouture®/XEOMIN® ,
a
neurotoxin
free
of
complexing
protein
Increases direct commercial presence
+75 reps and +25 clinical trainers in the U.S.
World-class talent.  Strong cultural fit
BioForm Medical’s team to join Merz
Building on Merz’s
history of providing innovative and
effective products to the aesthetic medical community


19
|  Page
Transaction Overview
(1)€1 = US$1.433. Based on exchange rate at 12/31/09
(2)Subject
to
the
tender
of
a
majority
of
the
outstanding
shares
of
BioForm
Medical
common
stock,
regulatory approvals, customary closing conditions
Purchase Price
Consideration
Expected Closing
Transaction Structure
US$253
million
(€177
million )
equity
value
US$5.45 per share via cash tender offer
60% premium to BFRM closing stock price on 12/31/09
55% premium to 30-day BFRM average closing stock price
BioForm Medical to become a wholly-owned subsidiary of Merz
and renamed Merz Aesthetics
First
quarter
of
calendar
year
2010
2
1


20
|  Page
Neramexane
in Tinnitus


21
|  Page
21
Tinnitus is a widespread condition
Note: Objective Tinnitus not considered
Source: American Tinnitus Association (ATA); Datamonitor
Description of Tinnitus
Perception
of
sound
(e.g. ringing, hissing,
buzzing) in the absence of
external equivalent
Tinnitus prevalence: 5-7%
Impaired signal processing in ear and brain can
lead to manifestation of sound
Multiple causes
can
lead to "ringing" in the
ear that normally
disappears
5%
4%
5%
7%
5%
Tinnitus
6%
Asthma
9%
Migraine
7%
Diabetes II
High estimation
Conservative estimation


|  Page 22
No treatment proven to be effective
1. Biesinger, (1998), Stat. Tin. HNO, 46    2. Hahn, A, Int tinnitus J (2008).  3. Desloovere, C HNO 36 (1988); Desloovere, C, Laryngo-Rhino-Otol 73 (1994)  4. Arzneimittelkommission:
Dtsch. Ä rztbl. 92 (1995) 5. Cochrane 2004  6. Smith et al 2005 J Ethnopharmparmacol 100(12)  7. Folmer Ear Nose Throat J (2004)  8. Robinson, Hear Res 226 (2005)   9. Baldo, Cochrane
(2006) 10. Cochrane 2007 Jan 24; Cochrane Database 2005   12. Savage, J, BMJ evidence 2007     13.  Martinez, Cochrane 2007


23
|  Page
However, ……
total costs for society of ~ $32bn
1. Calculated as human capital method assuming $1,350 per year per treated patient;  75% of 13.5M treated patients in working age;
Note: Chronic headache causes an estimated cost of $27M and chronic back pain ~$170M. Top 7 countries: US, JP, UK, DE, FR, IT, ES
Source: Petermann
(2005); National Center for Health Statistics; Coles: Epidemiology of tinnitus; Axelsson: tinnitus: a study; Pilgrimm: tinnitus in der BRD;  Merz expert interviews
0
10
20
30
40
9 -
12
Treatment
7 -
9
Doctors’
fees & Diagnostics
12 -
15
28 -
36
Total
Cost in bn$
Average chronic
patient misses 3 weeks
of work per year
Tinnitus-induced costs for society in top 7 markets
1
Indirect costs


24
|  Page
Patient  share in target segment
Average NER
DDD in $
Neramexane with blockbuster potential
~ $ 8 bn
equals current Tinnitus Market
~$ 4 bn
~$ 2 bn
Market potential of NERAMEXANE will exceed $ 1bn by far
~$ 1bn


25
|  Page
25
"...sleep
comfortable!"
"...stay in work!"
1.
TBF12
>9;
HADS
<10;
disease
duration
<12
month
2.
vs.
Placeb:
+18%
of
patients
with
improvement
and
-16%
of
patients
worse
3.
e.g.,
sport,
seeing
friends,
restaurant
visits;
+18%
of
patients
with improvement and -8% of patients worse 4. vs. placebo
Source: Merz market research; Merz Phase II trial
"...enjoy life!"
+23%
+37%
+2h
+49%
Additional hours/day
without annoyance
Patients with
improved
social
life
Patients with better
capability
to
work
Tailor made, multiple receptor mode of action
First-time high quality phase II trial in tinnitus
(n>400)
Clean safety profile proven in 1,500 individuals
Good tolerability
Convenient oral treatment
Neramexane
first oral Tinnitus Medication in Phase III
Sustainable global market exclusivity based upon comprehensive IP package (substance, synthesis and use patents)
Largest Phase III program ever in Tinnitus well on track
Neramexane
key facts
Encouraging phase II efficacy
in
relevant
patient
population
Additional patients
sleep well!
4
3
2
1


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|  Page
Neramexane
more than a wild card
Significant unmet medical need
Vastly
untapped
market
-
the
patient
is
waiting
Strong scientific rationale
Solid initial clinical data
Strong IP Portfolio
Strong
Japanese
Partner
on
board
-
ENT
specialist
Kyorin
Phase III clinical trials ongoing, first results 2nd quarter 2010; further
partnership discussions initiated


27
|  Page
Summary


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|  Page
Merz Pharma: continued growth in specialty segments
Our future growth will be based on
an innovative pipeline from own R&D, R&D collaborations and licensing
a
commitment
and
financial
capability
to
invest
into
our
own
organisations
to
expand
our international footprint,
further building partnerships for our products and
selectively pursuing M&A
We are determined to
build an international company out of a strong German heritage
establish leadership positions in Medical Aesthetics, Specialty CNS and Tinnitus


29
|  Page
Thank you!
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