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Filed by Insmed, Inc.
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
of the Securities Exchange Act of 1934
Subject Company: Insmed, Inc.
Commission File No. 333-30098
Insmed Incorporated
Geoffrey Allan, PhD
President and Chief Executive Officer
S.G. Cowen 20th Annual Healthcare Conference
March 8, 2000
[Insmed logo]
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Safe Harbor Statement
This presentation contains forward-looking statements regarding future events or
the future performance of the Company that involve certain risks and
uncertainties. Actual events or the actual future results of the Company may
differ materially from any forward-looking statements due to a variety of
factors including, but not limited to, (1) the ability to enter into
collaborative agreements with corporate partners, (2) the efficacy and safety of
the Company's products, (3) results of clinical trials, (4) the ability to
timely enroll patients in the Company's clinical studies, (5) significant
unforseen delays in the regulatory approval process, (6) complications relating
to the use of the Company's products, (7) competitive products and technology,
and (8) the ability to raise additional capital.
[Insmed logo]
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RICHMOND, Virginia - December 1,1999 - INSMED Pharmaceuticals, Inc. (a
privately-held biopharmaceutical company) and Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) announced today that they had entered into a definitive agreement
for INSMED to acquire Celtrix.
[Insmed logo]
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Transaction Update
. Target close: April/May 2000
. Terms: Exchange of stock
. New name: Insmed Incorporated
. New ticker: INSM
. Listing: NASDAQ
. Market cap: ~$1 billion
. Projected cash at closing: ~$50 million
[Insmed logo]
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Key Features
. Metabolic and endocrine focus
. Two, phase II clinical products with demonstrated efficacy and safety in 4
approvable indications
. Experienced drug development management team
[Insmed logo]
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Products & Markets
Our products target large and high growth markets with unmet needs
. INS-1 - naturally occurring oral insulin sensitizer
- Type 2 diabetes > $3 billion
- PCOS > $0.5 billion
. SomatoKine - naturally occurring insulin like growth factor protein complex
- Type 1 & 2 diabetes > $1 billion
- Osteoporotic hip fracture recovery > $0.8 million
[Insmed logo]
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INS-1 Emerging Profile
. Orally active
. Pre-clinical safety pharmacology, 6-month toxicology and teratology complete
. Low cost methods of manufacture identified
. 2 Active INDs: PCOS and type 2 diabetes
. Excellent clinical safety profile observed in over 400 treated subjects
. Efficacy established in 2 indications
[Insmed logo]
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What is PCOS?
. Major women's health disorder - 10% of premenopausal women affected
. Leading cause of infertility
. Increased risk for type 2 diabetes, cardiovascular disease and endometrial
cancer
. No approved therapy
[Insmed logo]
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PCOS Features
. Insulin resistance leading to increased blood levels of insulin and
testosterone
. Increased body weight
. Excess facial hair
. Failure to ovulate
[Insmed logo]
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INS-1 Efficacy in PCOS
. Phase II clinical trials in PCOS demonstrate that INS-1 causes
- greater than 50% reduction in insulin and free testosterone blood levels
- resumption of ovulation in 90% of treated subjects
[Insmed logo]
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The PCOS Opportunity
We will seek INS-1 approval in the US
Product claim: INS-1 is indicated for the treatment of ovulatory, endocrine and
metabolic abnormalities associated with PCOS
Potential for "First in class" approval
Rapid acceptance by focused physician groups
[Insmed logo]
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INS-1 Efficacy in Type 2 Diabetes
. Phase II clinical trials demonstrate that INS-1
- improves glycemia
- improves lipids
- does not increase body weight
. Superior product profile to existing drugs
[Insmed logo]
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The Type 2 Diabetes Opportunity
We will seek approval in the US for INS-1 as first line therapy
Product claim: INS-1 is indicated as an adjunct to diet and exercise to improve
glycemic control in patients with type 2 diabetes
We propose that INS-1 will be used in combination with other oral hypoglycemic
agents and insulin
[Insmed logo]
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INS-1 Development 2000
PCOS
. 3-month treatment with clomiphene add-on
. 6-month treatment to evaluate ovulatory, endocrine, metabolic effects
Diabetes
. 3-month treatment in combination with sulfonylurea
. 6-month treatment as adjunct to diet and exercise
[Insmed logo]
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What is SomatoKine?
. Naturally occurring protein bound complex of insulin like growth factor-I
[IGF-I] [BP-3] A novel therapeutic composition
[Insmed logo]
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Why SomatoKine?
. IGF-1 is absolutely required for normal metabolism and bone growth
. IGF-1 is a potent insulin sensitizer
. SomatoKine provides safe & effective delivery of IGF-1
- A true physiological replacement
[Insmed logo]
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SomatoKine - Emerging Profile
. Pre-clinical toxicology, 3-month studies in 2 species complete
. Clinical grade manufacturing process in place
. Active IND
. Excellent clinical safety profile observed in over 100 treated subjects
. Efficacy established in 3 indications
[Insmed logo]
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SomatoKine - Clinical Efficacy
In Phase II clinical trials in type I diabetics SomatoKine
. reduced insulin requirements 49%
. improved blood glucose by an additional 23%
[Insmed logo]
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SomatoKine Clinical Safety
In Phase II clinical trials in type I diabetics SomatoKine had an improved
safety profile compared to IGF-1 alone.
IGF-1 SomatoKine
----- ----------
Jaw Pain 80% 0%
Arthralgias 43% 0%
Headache 28% 0%
Edema 25% 0%
[Insmed logo]
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SomatoKine Opportunity
We will seek approval in the US for SomatoKine
Product claims:
. SomatoKine is indicated to improve glycemic control in type 1 & 2 diabetes
patients that have failed to achieve adequate control with insulin therapy
. SomatoKine is indicated for the augmented functional recovery from severe
osteoporotic hip fracture
[Insmed logo]
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SomatoKine Development 2000
Diabetes
. 3-month treatment to evaluate insulin sensitizing effect in a parallel,
placebo controlled, dose range-finding study with 3-month follow-up
Hip Fracture
. 2-month treatment with 6-month evaluation of effects on functional recovery
and bone mineral density
[Insmed logo]
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Vision
Our goal is to be a leader in the development of drugs to treat metabolic and
endocrine disorders.
. We will retain U.S. product development rights
. We will not be a royalty stream driven company
. We will partner to enable global development and maximize revenues
[Insmed logo]
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Insmed Incorporated
Geoffrey Allen, PhD
President and Chief Executive Officer
S.G. Cowen 20th Annual Healthcare Conference
March 8, 2000
[Insmed logo]
The matters discussed throughout these materials filed pursuant to Rule 425
under the Securities Exchange Act of 1933 on March 10, 2000, that are not
historical facts are forward-looking and, accordingly, involve estimates,
projections, goals, forecasts, assumptions and uncertainties that could cause
actual results or outcomes to differ materially from those expressed in the
forward-looking statements.
These forward-looking statements may include, but are not limited to,
future capital expenditures, acquisitions (including the amount and nature of
acquisitions), future revenues, earnings, margins, costs, demand for new
pharmaceutical products, market trends in the pharmaceutical business, inflation
and various economic and business trends. You can identify forward-looking
statements by the use of words such as "expect," "estimate," "project,"
"budget," "forecast," "anticipate," "plan" and similar expressions. Forward-
looking statements include all statements regarding expected financial position,
results of operations, cash flows, dividends, financing plans, business
strategies, operating efficiencies or synergies, budgets, capital and other
expenditures, competitive positions, growth opportunities for existing or
proposed products or services, plans and objectives of management, and markets
for stock of Insmed, Inc., Celtrix and Insmed Pharmaceuticals.
Any forward-looking statement speaks only as of the date on which the
statement was made.
Examples of factors that should be considered with respect to any forward-
looking statements made throughout these materials include, but are not limited
to, the following:
o Legislative and regulatory initiatives that impact the provision of
pharmaceutical products and services;
o Market demand for pharmaceutical products and services, changes in the
economies of areas served by the companies and catastrophic natural
disasters;
o The ability of Celtrix, Insmed Pharmaceuticals, Insmed, Inc., their suppliers
and customers to successfully address Year 2000 readiness issues;
o Unanticipated changes in operating expenses and capital expenditures;
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o General industry trends and the effects of vigorous competition in the
biotechnology, biopharmaceutical and pharmaceutical industries;
o Financial or regulatory accounting principles or policies imposed by the
Financial Accounting Standards Board, the Securities and Exchange Commission
and similar agencies with regulatory oversight;
o Employee workforce factors, including loss or retirement of key executives
and scientists;
o Technological developments resulting in competitive disadvantages and
creating the potential for impairment of existing assets;
o Unexpected costs or difficulties related to the integration of the businesses
of Celtrix and Insmed Pharmaceuticals;
o Regulatory delays or conditions imposed by regulatory bodies in approving the
reorganizations;
o General economic factors including inflation and capital market conditions;
and
o Adverse changes in the securities markets.
These factors are difficult to predict. They also contain uncertainties
that may materially affect actual results, and may be beyond the control of
Celtrix, Insmed Pharmaceuticals or Insmed, Inc. New factors may emerge from
time to time and it is not possible for us to predict new factors, nor can we
assess the effect of any new factors on Celtrix, Insmed Pharmaceuticals or
Insmed, Inc.
These forward-looking statements are found at various places throughout
these materials. We caution you not to place undue reliance on these forward-
looking statements, which speak only as of the date they were made. None of
Celtrix, Insmed Pharmaceuticals or Insmed, Inc. undertakes any obligation to
publicly release any revisions to these forward-looking statements to reflect
events or circumstances after the date of this filing pursuant to Rule 425 or to
reflect the occurrence of unanticipated events.
In connection with the reorganizations of Insmed Pharmaceuticals and
Celtrix into a newly formed holding company, Insmed, Inc., Insmed, Inc. has
filed with the Securities and Exchange Commission (the "SEC") a Registration
Statement on Form S-4 (File No. 333-30098) containing the joint proxy
statement/prospectus of Insmed Pharmaceuticals and Celtrix. Insmed, Inc. will
also be filling an amended Registration Statement on Form S-4 which will contain
the definitive joint proxy statement/prospectus of Insmed Pharmaceuticals and
Celtrix in addition to other relevant documents concerning the reorganizations
with the SEC. WE URGE INVESTORS TO READ THE DEFINITIVE JOINT PROXY
STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS TO BE FILED WITH THE SEC
BECAUSE THEY CONTAIN IMPORTANT INFORMATION. Investors will be able to obtain
the documents free of charge at the SEC's web site, http://www.sec.gov. In
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addition, documents filed by Insmed, Inc. with the SEC can be obtained by
contacting Insmed, Inc. at the following address and telephone number: 800 East
Leigh Street, Richmond, Virginia 23219, Attention: Michael D. Baer, Telephone
(804) 828-6893. Information about Insmed Pharmaceuticals can be obtained by
contacting Insmed Pharmaceuticals at the following address and telephone number:
800 East Leigh Street, Richmond, Virginia 23219, Attention: Michael D. Baer,
Telephone (804) 828-6893. Documents filed with the SEC by Celtrix can be
obtained by contacting Celtrix at the following address and telephone number:
2033 Gateway Place, Suite 600 San Jose, California 95110, Attention: Donald D.
Huffman, Telephone (408) 988-2500. READ THE DEFINITIVE JOINT PROXY
STATEMENT/PROSPECTUS CAREFULLY BEFORE MAKING A DECISION CONCERNING THE
REORGANIZATIONS.
Insmed Pharmaceuticals, its directors, executive officers and certain other
members of management and employees may be soliciting proxies from Insmed
Pharmaceuticals shareholders in connection with the reorganizations.
Information concerning the participants in the solicitation is set forth in the
preliminary joint proxy statement/prospectus included in the Registration
Statement on Form S-4 filed by Insmed, Inc. with the SEC on February 10, 2000.
Celtrix, its directors, executive officers and certain other members of
management and employees may be soliciting proxies from Celtrix stockholders in
connection with the reorganizations. Information concerning the participants in
the solicitation is set forth in the preliminary joint proxy
statement/prospectus included in the Registration Statement on Form S-4 filed by
Insmed, Inc. with the SEC on February 10, 2000.
