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Genentech Inc – ‘DEFA14A’ on 11/17/06

On:  Friday, 11/17/06, at 5:08pm ET   ·   Effective:  11/17/06   ·   Accession #:  1193125-6-238415   ·   File #:  1-09813

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

11/17/06  Genentech Inc                     DEFA14A    11/17/06    1:1.4M                                   RR Donnelley/FA

Additional Definitive Proxy Solicitation Material   —   Schedule 14A
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: DEFA14A     Soliciting Material Pursuant to Rule 240.14A-12     HTML    154K 


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  Soliciting Material Pursuant to Rule 240.14A-12  

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

 

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Check the appropriate box:

 

¨ Preliminary Proxy Statement

 

¨ Confidential, For Use of the Commission only (as permitted by Rule 14a-6(e)(2))

 

¨ Definitive Proxy Statement

 

¨ Definitive Additional Materials

 

x Soliciting Material Pursuant to §240.14a-12

 

 

Genentech, Inc.

(Name of Registrant as Specified in its Charter)

 

 


(Name of Person(s) Filing Proxy Statement, if other than the Registrant)

 

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

 

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#1
Genentech:  An Overview
Genentech:  An Overview
Patrick Yang, Executive Vice President
Manufacturing, Genentech


#2
Meeting Agenda
Introduction to Genentech
Pat Yang
Manufacturing
Next steps
Pat Yang
Q&A
All


#3
Manufacturing
Manufacturing
Genentech is a world leader in biotech
manufacturing, with more FDA-approved
manufacturing capacity for the production of
biotech medicines than any other company
Four facilities:  South San Francisco, CA;
Vacaville, CA and Oceanside, CA and
Porriño, Spain
We believe we have the right plans in place
to meet the growing demand for our
products:
Oceanside facility purchased from Biogen
Idec in 2005
Option to purchase facility in Singapore
Working with Lonza, Wyeth and Novartis
Process yield improvements for Rituxan and
Avastin
New capacity coming online for bulk and
filling/packaging


#4
Q4’06, announced Lonza will acquire our
40,000 liter facility in Porriño,
Spain; Lonza will
continue production of Avastin for Genentech
for 3 years
We anticipate closing the transaction before
the end of 2006
Porriño, Spain
(Lonza Biologics)
Status
Enhancement Project
Facility
Anticipate construction, qualification and
licensure of our new plant in Vacaville,
California in 2H’09 (additional 200,000 liters)
Vacaville, CA
CCP2
Genentech Bulk
Manufacturing
Oceanside, CA
NIMO
Anticipate
FDA licensure to produce
commercial Avastin in 1H’07 (90,000 liters)
Manufacturing
Wyeth BioPharma
Andover,
MA
Received
FDA licensure to produce Herceptin
Q3’06
Process
Improvements
Rituxan
Anticipate
approval of higher titer Rituxan
process in Vacaville by the end of 2006
(+50%)
Avastin
Anticipate
approval of higher titer Avastin
process in South San Francisco by the end of
2006 (+50%)
Near-term Key Capacity Enhancement
Projects
Near-term Key Capacity Enhancement
Projects


#5
Novartis
Pharmaceuticals
Huningue, France
Began manufacturing all future worldwide
supply of Xolair
Wyeth BioPhmara
Andover, MA
Received FDA licensure to produce
Herceptin
Lonza Biologics
Porrino, Spain
Announced Lonza will acquire our 40,000
liter facility in Porriño, Spain; facility will
continue production of Avastin for 3 years
Lonza Biologics
Singapore
Entered into long-term supply agreement
with Lonza to manufacture Genentech
products at their 80,000-liter facility in
Singapore; We have an exclusive option
to purchase the Singapore facility in the
future
2006 Key Contract Manufacturing
Accomplishments
2006 Key Contract Manufacturing
Accomplishments
Our strategies include expanding or acquiring facilities and engaging
contract manufacturers that produce Genentech’s products on our
behalf


#6
Completed qualification runs of Avastin at Oceanside
Expect FDA licensure to produce Avastin 1H’07
Purchased state-of-the-art finish/fill facility in
Hillsboro, Oregon
Expect facility to be licensed and operational in 2010
Expect FDA approval of high titer processes for
Rituxan (in Vacaville) and Avastin (in SSF)
Signed two new product supply agreements with
Roche
Other 2006 Manufacturing Accomplishments
Other 2006 Manufacturing Accomplishments


#7
Genentech’s Oceanside Facilities
Genentech’s Oceanside Facilities
Manufacturing Facility
Manufacturing Facility
NIMO
Commercial Facility
NICO
Clinical Facility
Purchased
Purchased
June 2005
February 2006
Potential Capacity
Potential Capacity
90,000 liters
5,500 liters
# of Employees
# of Employees
Approximately 530 employees as  
Plan to employ approximately 30
employees  by the end of 2006
Status
Status
Q3’06 completed qualification
runs
of Avastin
Expect FDA licensure
to produce
Avastin
in 1H’07
Expect to be operational by
Q1’07
QuickTime™ and a
MPEG-4 Video decompressor
are needed to see this picture.


#8
-
Potential to purchase Lonza Singapore Facility
610,000 Liters
Option
to
Purchase
from
2007
-
2010
Q406 Genentech obtained an exclusive option to purchase the Lonza Singapore facility
during the period from 2007 to 2012
Licensure to produce Avastin is expected in 2010
80,000 liters
Lonza Singapore Facility
Q406,
announced
Lonza
will
acquire
our
40,000
liter
facility
in
Porriño,
Spain;
Lonza
will
continue
production
of
Avastin
for
Genentech for 3 years.
We anticipate closing the transaction before the end of 2006.
Lonza Biologics, Porriño, Spain
Comments
Other
Comments
Potential Capacity
Genentech Bulk Manufacturing Facility
240,000 Liters
Current Total Capacity in Use
-
Potential addition of Vacaville, CA
530,000 Liters
Potential Capacity in 1H’09
-
Potential addition of Oceanside, CA
330,000 Liters
Potential Capacity in 1H’07
Comments
Contract Manufacturing (Bulk)
Expect FDA licensure in 2H09
200,000 (8x25,000L)
Vacaville, CA (CCP2)
In July 2006, Roche signed two new product supply agreements which supplement and supersede existing product supply
agreements.
Roche
has
agreed
to
purchase
specified
amounts
of
Herceptin,
Avastin
and
Rituxan
through
2008
and
to
purchase
specified
amounts
of
Herceptin
and
Avastin
through
2012.
Previously, Roche had assumed most of their own ex-US Herceptin supply and was planning on assuming all their ex-
US Avastin supply.
Genentech has and will continue to supply all of Roches ex-U.S. Rituxan supply.
Roche, Penzberg, Germany
Received FDA licensure in Q106 to produce bulk substance Xolair (will produce all future worldwide supply). As of Q306,
Genentech
will
acquire
bulk
supply
of
Xolair
from
Novartis
and
compensate
them
on
a
cost
plus
mark
up
basis.
Novartis Pharmaceuticals, Huningue, France
Received
FDA
licensure
in
Q3’06
to
produce
Herceptin;
expect
Wyeth
to
produce
25%
of
Herceptin
over
the
next
several
years.
Genentech
will
produce
the
remainder
in
Vacaville.
Wyeth BioPharma, Andover, MA
Received FDA licensure in Q305 to produce Rituxan; expect Lonza to produce ~50% of Rituxan over the next several years.
Genentech will produce the remainder in our other facilities.
Q306 we completed qualification runs of Avastin
Expect
FDA
licensure
to
produce
Avastin
in
1H’07
First licensed in 2000. Licensed to produce Avastin, Herceptin, Rituxan, Xolair.
First licensed in 1985. Licensed to produce Activase, Avastin, Cathflo Activase, Herceptin,
Lucentis, Nutropin, Nutropin AQ, Pulmozyme, Raptiva, Rituxan, and TNKase.
Comments
Lonza Biologics, Portsmouth, NH
90,000 (6x15,000L)
Oceanside, CA (NIMO)
144,000 (12x12,000L)
Vacaville, CA (CCP1)
96,000 (8x12,000L)
South San Francisco, CA
Current Capacity
Genentech Bulk Manufacturing Facility
Manufacturing Capacity
Manufacturing Capacity


#9
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
500,000
550,000
600,000
650,000
1999
2000
2001
2002
2003
2004
2005
2006
1H'07
2008
2H'09
2010
*Chinese Hamster Ovary Cell Culture
Note:
In
Q4’06,
Genentech
has
entered
into
an
agreement
with
Lonza
to
purchase
Genentech's
Porrino,
Spain
manufacturing
facility.
Concurrently,
we
entered
into
a
supply
agreement
for
the
manufacture
of
certain
Genentech
products
at
Lonza's
facility
currently
under
construction
in
Singapore,
with
Genentech
also
receiving
the
right
to
exercise
an
exclusive
option
to
purchase
the
Lonza
Singapore
facility
during
the
period
from
2007
to
2012.
The
transactions
are
subject
to
various
closing
conditions..
Genentech Commercial Cell Culture*
Bioreactor Capacity
Genentech Commercial Cell Culture*
Bioreactor Capacity
Current Commercial Capacity
South San Francisco, CA and Vacaville, CA (CCP1)


#10
What Does This Mean For You?
What Does This Mean For You?
We encourage continued focus on your current efforts to bring
important new medicines to patients, as this is in everyone’s best
interest
While we fully expect the deal to go through, we aren’t there yet
Your current management continues to run the company until
close
Once the GNE and Tanox transition teams are up and running,
more detailed information will be available on next steps, key
milestones, etc.
Most importantly, we recognize that this is an uncertain time for
Tanox employees.   Consistent with our values, our intent is to treat
Tanox employees with the same respect & integrity that we treat our
own employees


#11
Transition Process Will Be Organized Around Four Areas
Transition Process Will Be Organized Around Four Areas
EC / Legal
EC
Product
Portfolio
Committee
Research
Review
Committee
EC / PROP
Executive Team
Decision
maker
Feb 28, 2007*
3.Recomm
end-ation
Feb 10, 2007*
Jan 31, 2007*
2.
Evaluation
Number of
contracts; Rights
and obligations of
each
Number of
employees by
functional area
Number and
value of R&D
programs
Number, location,
and capability of
facility
1.
Assessmen
t
HR
Change
management
R&D
Programs
Facilities/
Property
Process Summary
* All dates are tentative


#12
Decisions Yet to be Determined
Decisions Yet to be Determined
Future plans for Tanox’s pipeline
Future plans for Tanox’s sites
Future status of employees
Who will be retained
How/when decisions will be made after close;
however, our intent is for decisions to be made
as quickly and with as much transparency as
possible
Where retained employees will be located
Details of post-close integration and timeline


#13
Next Steps
Next Steps
Today:
Small functional meetings with Genentech and Tanox
management
Next few months:
Additional site visits to establish post-close integration plans
Deal not closed until at least Q1’07; Tanox remains an
independent company until the deal closes.  It is important to
stay focused and keep moving projects forward during this time:
Tanox shareholder vote
Hart-Scott-Rodino
submission and review
Review of deal by Federal Trade Commission
Transition team established


#14
Genentech Transition Team
Ashraf Hanna,
Team Leader
Mark Asbury
Leigh Morgan
Charles Calderaro
Sean Bohen
Andy Chan
Neil
Cohen
R&D
HR
Facilities/
Property
Communi
cation
Ray Sanchez-
Pescadore,
Project Manager
Brian Muma


#15
Forward Looking
Statement
Forward Looking
Statement
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements include, among other things, our expectations
regarding the closing of the
acquisition and the integration of the operations of Tanox, our belief that we have the right plans in place to meet future
demand for our products, our belief regarding the future growth and profitability of Xolair and anti-IgE inhibition products, our
future product development plans (including anti-IL 13 Mab for asthma, anti-Factor D Mab for dry AMD and anti-CD4 for
HIV), our expectations regarding the timing of our evaluations and decisions for transition plans, and the timing of and actual
severance payment amounts for Tanox employees; planned manufacturing expansions and our manufacturing capacity,
including expected timeframes for FDA filings and approval for licensure of manufacturing facilities and expected timeframe
for facilities to become operational; and FDA approvals of yield
improvements. Actual results could differ materially. Among
other things, the transaction and its timing could be affected or prevented by failure of certain closing conditions to occur,
including FTC or other regulatory actions or delays; integration
of the Tanox business (including the timing of our decisions
regarding such integration) could be affected by failures in our
due diligence review of the Tanox business and failure to
retain certain key employees; growth and profitability of our asthma and anti-IgE business (including Xolair) could be
affected by adverse market conditions, increased competition, delay or failure of clinical programs, and safety or
manufacturing issues; future development plans may be affected by changes in our corporate strategy, increased
competition, regulatory actions or delays, unsuccessful clinical
trials or third party intellectual property rights; Xolair clinical
trials could be affected by a number of factors including unexpected safety, efficacy or manufacturing issues, additional time
requirements for data analysis and FDA actions or delays; achieving sales revenue consistent with internal forecasts,
unexpected expenses such as litigation or legal settlement expenses, changes in tax rules, adverse market conditions,
increased competition, regulatory actions or delays; the severance described in this presentation will be subject to other
terms and conditions set forth in the severance plan established
by Genentech (including the execution of a release by each
eligible employee); and the expected FDA filings and licensure timeframes, planned manufacturing expansions,
manufacturing capacity, timeframes for FDA approvals of yield improvements and timeframe when manufacturing facilities
will become operational could be affected by a number of factors
including FDA or other regulatory actions or delays, failure
to receive FDA approval and other delays or manufacturing issues. Please refer to Genentech’s periodic reports filed with
the Securities and Exchange Commission. Such reports contain and
identify important factors that could cause actual
results to differ materially from those contained in our forward-looking statements. All such risk factors, including those found
in our most recent Form 10-Q, are incorporated by reference into this transcript. We undertake no obligation to update or
revise any forward-looking statements in the future.


#16
Thank You
Thank You


#17
Q&A Session
Q&A Session


This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among other things, our expectations regarding the closing of the acquisition and the integration of the operations of Tanox, our future product development plans with regard to Tanox’s pipeline, our expectations regarding the timing of our evaluations and decisions for transition plans, planned manufacturing expansions and our manufacturing capacity, including expected timeframes for FDA filings and approval for licensure of manufacturing facilities and expected timeframe for facilities to become operational; and FDA approvals of yield improvements. Actual results could differ materially. Among other things, the transaction and its timing could be affected or prevented by failure of certain closing conditions to occur, including FTC or other regulatory actions or delays; integration of the Tanox business (including the timing of our decisions regarding such integration) could be affected by failures in our due diligence review of the Tanox business and failure to retain certain key employees; future development plans may be affected by changes in our corporate strategy, increased competition, regulatory actions or delays, unsuccessful clinical trials or third party intellectual property rights; and the expected FDA filings and licensure timeframes, planned manufacturing expansions, manufacturing capacity, timeframes for FDA approvals of yield improvements and timeframe when manufacturing facilities will become operational could be affected by a number of factors including FDA or other regulatory actions or delays, failure to receive FDA approval and other delays or manufacturing issues. Please refer to Genentech’s periodic reports filed with the Securities and Exchange Commission. Such reports contain and identify important factors that could cause actual results to differ materially from those contained in our forward-looking statements. All such risk factors, including those found in our most recent Form 10-Q filed with the Securities and Exchange Commission, are incorporated by reference into this transcript. We undertake no obligation to update or revise any forward-looking statements in this presentation in the future.


Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘DEFA14A’ Filing    Date    Other Filings
2/28/07
2/10/07
1/31/07
Filed on / Effective on:11/17/064
11/9/068-K
9/30/0610-Q
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