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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON AUGUST 20, 1998
REGISTRATION NO. __________
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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CELTRIX PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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DELAWARE 2834 94-3121462
(State or Other Jurisdiction of (Primary Standard Industrial (I.R.S. Employer
Incorporation or Organization) Classification Code Number) Identification Number)
3055 PATRICK HENRY DRIVE
SANTA CLARA, CALIFORNIA 95054-1815
(408) 988-2500
(Address, Including Zip Code, and Telephone Number, Including Area
Code, of Registrant's Principal Executive Offices)
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ANDREAS SOMMER, PH.D.
PRESIDENT AND CHIEF EXECUTIVE OFFICER
3055 PATRICK HENRY DRIVE
SANTA CLARA, CALIFORNIA 95054-1815
(408) 988-2500
(Name, Address Including Zip Code, and Telephone Number Including
Area Code, of Agent for Service)
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COPIES TO:
Craig W. Johnson
Edmund S. Ruffin, Jr.
VENTURE LAW GROUP
A Professional Corporation
2800 Sand Hill Road
Menlo Park, CA 94025
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED
SALE TO THE PUBLIC: AS SOON AS PRACTICABLE AFTER THE
EFFECTIVE DATE OF THIS REGISTRATION STATEMENT.
If the only securities being registered on this form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. |_|
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. |X|
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. |_| _______________
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. |_| _______________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. |_|
CALCULATION OF REGISTRATION FEE
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TITLE OF EACH CLASS OF AMOUNT TO BE PROPOSED MAXIMUM OFFERING PROPOSED MAXIMUM AGGREGATE AMOUNT OF
SECURITIES TO BE REGISTERED REGISTERED PRICE PER UNIT (1) OFFERING PRICE (1) REGISTRATION FEE
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Common Stock, par value $0.01 9,000,000 $1.46875 $13,218,750.00 $3,899.54
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(1) Estimated solely for the purpose of computing the amount of the
registration fee based on the average of the high and low closing price of the
Common Stock as reported on the Nasdaq National Market on August 17, 1998
pursuant to Rule 457(c).
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
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INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES
EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR
TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
SUBJECT TO COMPLETION, DATED AUGUST ___, 1998
CELTRIX PHARMACEUTICALS, INC.
9,000,000 SHARES
COMMON STOCK
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THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" COMMENCING ON PAGE 4 OF THIS PROSPECTUS FOR INFORMATION THAT SHOULD BE
CONSIDERED BY PROSPECTIVE INVESTORS.
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All references herein to "Celtrix" or the "Company" mean Celtrix
Pharmaceuticals, Inc. unless otherwise indicated by the context.
The 9,000,000 shares of Celtrix Pharmaceuticals, Inc. Common Stock, $.01
par value, covered by this Prospectus (the "Shares") are offered for the account
of certain stockholders of the Company (the "Selling Stockholders"). The Shares
will be issued (or will be issuable upon exercise of warrants to be issued) to
the Selling Stockholders in connection with a private placement (the "Private
Placement") of Company Common Stock and warrants to purchase Common Stock (the
"Warrants"). For additional information concerning this Private Placement, see
"Issuance of Common Stock and Warrants to Selling Stockholders." The Selling
Stockholders may sell the Shares from time to time on the Nasdaq National Market
in regular brokerage transactions, in transactions directly with market makers
or in certain privately negotiated transactions. See "Plan of Distribution."
Each Selling Stockholder has advised the Company that no sale or distribution
other than as disclosed herein will be effected until after this Prospectus
shall have been appropriately amended or supplemented, if required, to set forth
the terms thereof. The Company will not receive any proceeds from the sale of
the Shares by the Selling Stockholders.
Each of the Selling Stockholders may be deemed to be an "Underwriter," as
such term is defined in the Securities Act of 1933, as amended (the "Securities
Act").
On August 17, 1998, the last sale price of the Company's Common Stock on
the Nasdaq National Market was $1.5625 per share.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
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PRICE TO UNDERWRITING PROCEEDS TO
DISCOUNTS AND SELLING
PUBLIC OMISSIONS(1) STOCKHOLDERS(1)
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Per Share.................................. See Text Above See Text Above See Text Above
Total......................................
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(1) All expenses of registration of the Shares, estimated to be approximately
$__________ shall be borne by the Company. Selling commissions, brokerage
fees, any applicable stock transfer taxes and any fees and disbursements of
counsel to the Selling Stockholders are payable individually by the Selling
Stockholders.
The date of this Prospectus is August ___, 1998
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No person is authorized in connection with any offering made hereby to give any
information or to make any representation not contained in this Prospectus, and,
if given or made, such information or representation must not be relied upon as
having been authorized by the Company or the Selling Stockholders. This
Prospectus does not constitute an offer to sell or a solicitation of an offer to
buy any security other than the shares of Common Stock offered hereby, nor does
it constitute an offer to sell or a solicitation of an offer to buy any of the
shares offered hereby to any person in any jurisdiction in which it is unlawful
to make such an offer or solicitation. Neither the delivery of this Prospectus
nor any sale made hereunder shall under any circumstances create any implication
that the information contained herein is correct as of any time subsequent to
the date hereof.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act") and in accordance
therewith files proxy statements, reports and other information with the
Securities and Exchange Commission (the "Commission"). Reports, proxy and
information statements, and other information filed by the Company with the
Commission can be inspected and copied at the public reference facilities
maintained by the Commission in Washington, D.C., and at its Regional Offices
located at Citicorp Center, 500 West Madison Street, Suite 1400, Chicago,
Illinois 60661-2511 and 7 World Trade Center, Suite 1300, New York, New York
10048; and at the Public Reference Office of the Commission at 450 Fifth Street,
N.W., Washington, D.C. 20549. Copies of such material can be obtained from the
Public Reference Section of the Commission, 450 Fifth Street, N.W., Washington,
D.C. 20549 at prescribed rates. In addition, the Company is an electronic filer
and copies of such material may be retrieved from the Web site
(http://www.sec/gov) maintained by the Commission.
The Company's Common Stock is quoted on the Nasdaq National Market under
the symbol "CTRX." Reports, proxy and information statements and other
information about the Company may be inspected at the Nasdaq National Market,
1735 K Street, N.W., Washington, DC 20006-1506.
INFORMATION INCORPORATED BY REFERENCE
The following documents filed by the Company with the Commission are
incorporated by reference in this Prospectus:
1. The Company's Current Reports on Form 8-K dated July 15, 1998 and
July 23, 1998.
2. The Company's Annual Report on Form 10-K for the year ended March 31,
1998.
3. The Company's definitive Proxy Statement dated July 29, 1998, filed in
connection with the Company's September 10, 1998 Annual Meeting of Stockholders.
4. The Company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 1998.
5. The description of the Company's Common Stock set forth in the
Company's Registration Statement on Form 10 filed with the Commission on
January 24, 1991.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act after the date of this Prospectus and prior to the
termination of the offering of the Common Stock offered hereby shall be deemed
to be incorporated by reference in this Prospectus. Any statement
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contained in a document incorporated by reference herein shall be deemed to be
modified or superseded for purposes hereof to the extent that a statement
contained herein (or in any other subsequently filed document which also is
incorporated by reference herein) modifies or supersedes such statement. Any
such statement so modified or superseded shall not be deemed to constitute a
part hereof, except as so modified or superseded.
The Company will furnish without charge to each person, including any
beneficial owner, to whom this Prospectus is delivered, on the written or oral
request of such person, a copy of any or all of the documents incorporated by
reference, other than exhibits to such documents. Requests should be directed to
the Chief Financial Officer, Celtrix Pharmaceuticals, Inc., 3055 Patrick Henry
Drive, Santa Clara, California, 95054-1815, telephone: 408-988-2500.
The "Celtrix Pharmaceuticals" logo (used alone or with the Company's name)
and "Celtrix Pharmaceuticals" are trademarks of the Company; "SomatoKine" is a
registered trademark of the Company. All other tradenames and trademarks
appearing in this Prospectus are the property of their respective holders.
THE COMPANY
Celtrix Pharmaceuticals, Inc. ("Celtrix" or the "Company") is a
biopharmaceutical company developing novel therapeutics for the treatment of
seriously debilitating, degenerative conditions primarily associated with aging,
chronic diseases and severe trauma. The Company's focus is on restoring lost
tissues and metabolic processes essential for the patient's health and quality
of life. Product development programs target severe osteoporosis, including hip
fracture surgery in the elderly, diabetes, and acute traumatic injury as in
severe burns. Other potential indications include protein wasting diseases
associated with cancer, AIDS, advanced kidney failure, and other
life-threatening conditions.
The Company's leading drug candidate is SomatoKine, a naturally occurring
complex comprised of the anabolic hormone insulin-like growth factor-I (IGF-I)
and its primary binding protein, BP3. IGF-I is known to play a major role in
diverse biological processes, including bone and muscle formation, tissue
repair, and endocrine regulation. However, IGF-I does not naturally exist in
quantity free of its binding proteins, and limitations associated with
administering free IGF-I therapeutically have proven significant. When IGF-I is
bound to BP3, as it is in nature, it does not display these acute limitations.
The Company initiated a Phase II clinical feasibility study in January 1997
using SomatoKine to treat severely osteoporotic patients recovering from hip
fracture surgery. Interim results from the Phase II study have suggested that
short-term treatment with SomatoKine may help to minimize, or even prevent bone
loss in such patients, substantially improving patient recovery. The Company
plans to establish corporate partnership(s) for the continued global development
of SomatoKine for severe osteoporosis, including recovery from hip fracture
surgery.
The Company began a Phase II feasibility study in patients with severe
burns in July 1997. Preliminary data from the study suggest that SomatoKine has
a normalizing effect on protein synthesis and immune function which offers the
potential to provide critical protection from serious infection, speed recovery
and reduce the patient's hospital stay.
The Company initiated a Phase II feasibility study in Type I diabetes
patients in July 1998 to evaluate SomatoKine as a potential therapeutic in
managing glucose homeostasis in these patients.
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Furthermore, the Company plans to seek corporate collaborations to develop
SomatoKine for treatment of protein wasting in patients suffering from cancer,
AIDS, advanced kidney failure, and other life-threatening conditions.
SomatoKine's anabolic effects offer the potential to preserve and restore muscle
strength and mobility important for these patients' survival and quality of
life.
The Company manufactures SomatoKine for clinical trials at its Santa Clara,
California facility.
The Company has a product development, license and marketing agreement with
Genzyme Corporation ("Genzyme") for TGF-beta-2. Genzyme is currently developing
TGF-beta-2 for tissue repair and the treatment of systemic indications. Celtrix
is not currently pursuing an in-house TGF-beta-2 program.
The Company was spun off from Collagen Corporation and was incorporated in
Delaware in December 1990 as "Celtrix Laboratories, Inc." The Company changed
its name to "Celtrix Pharmaceuticals, Inc." in December 1991.
The Company's principal executive offices are located in Santa Clara,
California. The mailing address and telephone number are: 3055 Patrick Henry
Drive, Santa Clara, CA 95054-1815, telephone: (408) 988-2500.
RISK FACTORS
PROSPECTIVE PURCHASERS OF THE COMMON STOCK OFFERED HEREBY SHOULD CAREFULLY
CONSIDER THE FOLLOWING RISK FACTORS IN ADDITION TO THE OTHER INFORMATION
APPEARING IN OR INCORPORATED BY REFERENCE INTO THIS PROSPECTUS.
Early Stage of Development; No Developed or Approved Products
The Company's potential products are in research and development and no
material revenues have been generated to date from product sales. To achieve
profitable operations, the Company, alone or with others, must successfully
develop, obtain regulatory approval for, manufacture and market its potential
products. Much of the clinical development work for the Company's potential
products remains to be completed. No assurance can be given that the Company's
product development effort will be successfully completed, that required
regulatory approval will be obtained or that any products, if developed and
introduced will be successfully marketed or achieve market acceptance.
History of Operating Losses; Accumulated Deficit
The Company has incurred net operating losses in every year of operation
since its inception. As of June 30, 1998, the Company had an accumulated deficit
of approximately $120.5 million. Losses have resulted principally from costs
incurred in connection with the Company's research and development activities
and from general and administrative costs associated with the Company's
operations. The Company expects to incur substantial and increasing operating
losses for at least the next several years. The Company's ability to achieve
profitability will depend in part on completing the research and development of,
and obtaining regulatory approvals for, its products and successfully commencing
product commercialization.
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Possible Volatility of Stock Price; Dividend Policy
The market prices for securities of biopharmaceutical and biotechnology
companies have historically been highly volatile, and the market has from time
to time experienced significant price and volume fluctuations that are unrelated
to the operating performance of particular companies. Since the Company's Common
Stock became listed for public trading, its market price has fluctuated over a
wide range and the Company expects that it will continue to fluctuate.
Announcements concerning the Company or its competitors, the results of clinical
trials, technological innovations or new commercial products, government
regulations, developments concerning proprietary rights, litigation or public
concern as to safety of the Company's potential products as well as changes in
general market conditions may have a significant effect on the market price of
Celtrix's common stock.
The Company has never paid dividends on its capital stock and the Company
does not anticipate paying any cash dividends in the foreseeable future.
Future Capital Requirements and Uncertainty of Additional Funding
From time to time, it is necessary for the Company to raise additional
capital. Current cash, cash equivalents and short term investments, excluding
any proceeds from the Company's current equity offering, will be sufficient to
fund the Company's operations through September 1998. The development of the
Company's products requires the commitment of substantial resources to conduct
the time-consuming research and development, clinical studies and regulatory
activities necessary to bring any potential therapeutic products to market and
to establish production, marketing and sales capabilities. Such additional
funding will need to be raised through collaborative arrangements or through
public or private financings, including equity financing. Any additional equity
financing may be dilutive to stockholders, and any debt financing, if available,
may involve restrictions on the Company's ability to pay future dividends on its
capital stock or the manner in which the Company conducts its business.
There can be no assurance that any such financing will be available to the
Company or on terms attractive to the Company, or that the Company can enter
into a collaborative relationship with a corporate partner for the continuation
of the clinical trials for recovery from hip fracture surgery and the initiation
of trials for osteoporosis. The inability to obtain funds, or to enter into
additional corporate collaborations, will require the Company to delay, scale
back or eliminate some or all of its research and product development programs
or to license third parties to commercialize products or technologies that the
Company would otherwise seek to develop itself. These actions will have material
adverse effects on the Company's business, results of operations and prospects.
Stringent Government Regulation; Need for Product Approvals
The preclinical testing and clinical trials of any compounds developed by
the Company or its collaborative partners and the manufacturing and marketing of
any drugs resulting therefrom are subject to regulation by numerous federal,
state and local governmental authorities in the United States, the principal one
of which is the United States Food and Drug Administration (the "FDA"), and by
similar agencies in other countries in which drugs developed by the Company or
its collaborative partners may be tested and marketed (each of such federal,
state, local and other authorities and agencies, a "Regulatory Agency"). Any
compound developed by the Company or its collaborative partners must receive
Regulatory Agency approval before it may be marketed as a drug in a particular
country. The regulatory process, which includes preclinical testing and clinical
trials of each compound in order to establish its safety and efficacy, can take
many years and requires the expenditure of substantial
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resources. Data obtained from preclinical and clinical activities are
susceptible to varying interpretations which could delay, limit or prevent
Regulatory Agency approval. In addition, delays or rejections may be encountered
based upon changes in Regulatory Agency policy during the period of drug
development and/or the period of review of any application for Regulatory Agency
approval for a compound. Delays in obtaining Regulatory Agency approvals could
adversely affect the marketing of any drugs developed by the Company or its
collaborative partners, impose costly procedures upon the Company's and its
collaborative partners' activities, diminish any competitive advantages that the
Company or its collaborative partners may attain and adversely affect the
Company's ability to receive royalties, any of which could have a material
adverse effect on the Company's business, financial condition and results of
operations.
There can be no assurance that, even after such time and expenditures,
Regulatory Agency approvals will be obtained for any compounds developed by or
in collaboration with the Company. Moreover, if Regulatory Agency approval for a
drug is granted, such approval may entail limitations on the indicated uses for
which it may be marketed that could limit the potential market for any such
drug. Furthermore, if and when such approval is obtained, the marketing and
manufacture of the Company's products would remain subject to extensive
regulatory requirements, and discovery of previously unknown problems with a
drug or its manufacturer may result in restrictions on such drug or
manufacturer, including withdrawal of the drug from the market. Failure to
comply with regulatory requirements could, among other things, result in fines,
suspension of regulatory approvals, operating restrictions and criminal
prosecution. In addition, Regulatory Agency approval of prices is required in
many countries and may be required for the marketing of any drug developed by
the Company or its collaborative partners in such countries.
Uncertainties Related to Clinical Trials
Before obtaining regulatory approvals for the commercial sale of any of its
products under development, the Company must demonstrate through preclinical
studies and clinical trials that the product is safe and efficacious for use in
each target indication. The results from preclinical studies and early clinical
trials may not be predictive of results that will be obtained in large-scale
testing, and there can be no assurance that the Company's clinical trials will
demonstrate the safety and efficacy of any products or will result in marketable
products. A number of companies in the biotechnology industry have suffered
significant setbacks in advanced clinical trials, even after promising results
in earlier trials. For example, in fiscal year 1995, Celtrix discontinued its
in-house TGF-beta-2 program for the treatment of ophthalmic conditions as a
result of disappointing clinical study results.
The rate of completion of the Company's clinical trials is dependent upon,
among other factors, the rate of patient enrollment. Patient enrollment is a
function of many factors, including the size of the patient population, the
nature of the protocol, the proximity of patients to clinical sites and the
eligibility criteria for the study. Delays in planned patient enrollment may
result in increased costs and delays, which could have a material adverse effect
on the Company's business, financial condition and results of operations.
No Assurance of Market Acceptance
There can be no assurance that any products successfully developed by the
Company, if approved for marketing, will achieve market acceptance. The products
and therapies which the Company is attempting to develop will compete with a
number of well-established traditional drugs and therapies manufactured and
marketed by major pharmaceutical companies. The degree of market acceptance of
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any products developed by the Company will depend on a number of factors,
including the establishment and demonstration in the medical community of the
clinical efficacy and safety of the Company's product candidates, their
potential advantage over existing treatment methods, and reimbursement policies
of government and third-party payors. Competitors may also develop new
technologies or products which are more effective or less costly than SomatoKine
or perceived to be more cost-effective. There is no assurance that physicians,
patients or the medical community in general will accept and utilize any
products that may be developed by the Company. The Company's business, financial
condition and results of operations may be materially adversely affected if
SomatoKine does not receive market acceptance for any reason.
Substantial Competition
In each of the Company's potential product areas, competition from large
pharmaceutical companies, biotechnology companies and other companies,
universities and research institutions is substantial. At least three large
biotechnology and pharmaceutical companies with substantial financial and legal
resources have patent applications on file in the United States and abroad
directed at the production of recombinant IGF-I by various methods. Relative to
the Company, most of these entities have substantially greater capital
resources, research and development staffs, facilities and experience in
conducting clinical trials and obtaining regulatory approvals, as well as in
manufacturing and marketing pharmaceutical products. Furthermore, the Company
believes that competitors have used, and may continue to use, litigation to gain
competitive advantage. In addition, these and other entities may have or develop
new technologies or use existing technologies that are, or may in the future be,
the basis for competitive products.
Any potential products that the Company succeeds in developing and for
which it gains regulatory approval will have to compete for market acceptance
and market share. For certain of the Company's potential products, an important
factor in such competition may be the timing of market introduction of
competitive products. Accordingly, the relative speed with which the Company can
develop products, complete the clinical testing and regulatory approval
processes and supply commercial quantities of the product to the market are
expected to be important competitive factors. The Company expects that
competition will be based, among other things, on product efficacy, safety,
reliability, availability, timing and scope of regulatory approval and price.
There can be no assurance that the Company's competitors will not succeed in
developing technologies and products that are more effective than any that are
being developed by the Company or that would render the Company's technology and
products obsolete or noncompetitive. In addition, many of the Company's
competitors may achieve product commercialization or patent protection earlier
than the Company. The failure of the Company to compete effectively would have a
material adverse effect on the Company's business, financial condition and
results of operations.
Dependence on Proprietary Technology; Uncertainty of Patent Protection
The Company's success will depend in part on its ability to obtain
patents, maintain trade secrets and operate without infringing on the
proprietary rights of others, both in the United States and in other countries.
The patent positions of pharmaceutical, biopharmaceutical and biotechnology
companies, including the Company, are highly uncertain and involve complex legal
and factual questions. Patent law relating to the scope of claims in the
technology fields in which the Company operates is still evolving. The degree of
future protection for the Company's proprietary rights is therefore uncertain.
No consistent policy has emerged regarding the permissible breadth of coverage
of claims in biotechnology patents. Therefore, no assurance can be given that
any of the Company's or its licensors' patent applications will
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issue as patents or that any such issued patents will provide competitive
advantages for the Company's products or will not be successfully challenged or
circumvented by its competitors. In addition, there can be no assurance that
others will not independently develop substantially equivalent proprietary
technology that is not covered by the Company's patents or that others will not
be issued patents that may prevent the sale of the Company's proposed products
or require licensing and the payment of significant fees or royalties by the
Company.
At least three large biotechnology and pharmaceutical companies with
substantial financial and legal resources have issued patents and/or patent
applications on file in the United States and abroad directed at the production
and/or use of recombinant IGF-I by various methods. The earliest date of filing
of these patent applications is April 25, 1983. Unless and until all of these
applications issue, it is not possible to determine the breadth of these claims
regarding a process for IGF-I production or for the use of IGF-I for any
particular indication. Furthermore, a large biotechnology and pharmaceutical
company with substantial financial and legal resources has a patent issued in
the United States directed towards certain DNA molecules encoding BP3 and the
corresponding BP3 protein. This same patent was previously granted in Europe and
was successfully opposed by Celtrix. However, this large biotechnology and
pharmaceutical company has recently appealed the decision and there can be no
assurance that the appeal will not be successful, and it is not possible to
determine what, if any, claims will be reinstated or the breadth of such claims.
In addition, this large biotechnology company has been issued a patent directed
toward the subcutaneous bolus administration of IGF-BP3 for certain limited
areas of use. Each of the referenced companies can be expected to defend its
patent position vigorously.
Celtrix has developed a new process for the production of IGF and BP3 which
it does not believe will infringe on other patents relating to recombinant
protein production in general or on other patents relating to the production of
IGF and BP3 in particular, although there can be no assurance that a contrary
position will not be asserted. A large number of other companies have pending
patent applications and/or issued patents which claim certain methods of use of
IGF. There can be no assurance that third parties will not claim the Company's
technology, current or future products or manufacturing processes infringe the
proprietary rights of others. If other companies were to successfully bring
legal actions against the Company claiming patent or other intellectual property
infringements, in addition to any potential liability for damages, then the
Company could be required to obtain a license in order to continue to use the
affected process or to manufacture or use the affected products or cease using
such products or process if enjoined by a court. Any such claim, with or without
merit, could result in costly litigation or might require the Company to enter
into royalty or licensing agreements, all of which could delay or otherwise
adversely impact the Company's potential products for commercial use. If any
licenses are required, there can be no assurance that the Company will be able
to obtain any such license on commercially favorable terms, if at all, and if
these licenses are not obtained, the Company might be prevented from pursuing
the development of certain of its potential products. The Company's breach of an
existing license or failure to obtain or delay in obtaining a license to any
technology that it may require to commercialize its products may have a material
adverse impact on the Company.
Litigation, which could result in substantial costs to the Company, may
also be necessary to enforce any patents issued or licensed to the Company or to
determine the scope and validity of another party's proprietary rights. There
can be no assurance that the Company's issued or licensed patents would be held
valid by a court of competent jurisdiction. An adverse outcome in litigation or
an interference or other proceeding in a court or patent office could subject
the Company to significant liabilities to other parties, require disputed rights
to be licensed from other parties or require the Company to cease using such
technology, any of which could have a material adverse effect on the Company.
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Celtrix also relies on trade secrets to protect technology, especially
where patent protection is not believed to be appropriate or obtainable. Celtrix
attempts to protect its proprietary technology and processes in part by
confidentiality agreements with its employees, consultants and certain
contractors. There can be no assurance that these agreements will not be
breached, that the Company would have adequate remedies for any breach, or that
the Company's trade secrets will not otherwise become known or be independently
discovered by competitors in such a manner that the Company has no practical
recourse. To the extent that the Company or its consultants or research
collaborators use intellectual property owned by others in their work for the
Company, disputes may also arise as to the rights in related or resulting
know-how and inventions.
Limited Manufacturing Experience and Capacity
The Company's products must be manufactured in compliance with regulatory
requirements and at acceptable costs. At present, the Company's manufacturing
operations have been designed to address the Company's anticipated needs through
the completion of Phase II clinical trials. In the future, the Company will
either need to expand these operations or subcontract its manufacturing
operations in anticipation of Phase III studies and commercialization. There can
be no assurance that the Company will be able to manufacture any of its current
or future products on a commercial scale, nor that such products can be
manufactured by the Company or any other party at a cost or in quantities to
make commercially viable products. Failure to obtain sufficient commercial
quantities of SomatoKine at acceptable terms will have an adverse impact on the
Company's attempts to seek approval for this product, or to commercialize this
product.
Limited Sales and Marketing Experience
If the Company is permitted to commence commercial sales of products, it
will face commercial competition with respect to sales, marketing and
distribution, areas in which it has no experience. To market any of its products
directly, the Company must develop a marketing and sales force with technical
expertise and with supporting distribution capability. Alternatively, the
Company may obtain the assistance of a pharmaceutical company with a large
distribution system and a large direct sales force. There can be no assurance
that the Company will be able to establish sales and distribution capabilities
or be successful in gaining market acceptance for its proprietary products. To
the extent the Company enters into co-promotion or other licensing arrangements,
any revenues received by the Company will be dependent on the efforts of third
parties and there can be no assurance that such efforts will be successful.
Reliance on Qualified and Key Personnel
The Company is highly dependent on the principal members of its scientific
and management staff, the loss of whose services might significantly delay or
prevent the achievement of research, development, or business objectives. In
addition, the Company relies on consultants and advisors to assist the Company
in formulating its research and development strategy. Retaining and attracting
qualified scientific and management personnel, consultants and advisors is
therefore critical to the Company's success. There can be no assurance that the
Company will be able to hire sufficient qualified personnel on a timely basis or
retain such personnel. The loss of key management or scientific personnel could
adversely affect the Company's business.
The Company's potential expansion into areas and activities requiring
additional expertise, such as clinical trials, governmental approvals,
manufacturing and marketing, are expected to place a significant strain on the
Company's management, operational and financial resources. These demands are
expected
9
11
to require a substantial increase in management and scientific personnel and the
development of additional expertise by existing management personnel. The
failure to attract and retain such personnel or to develop such expertise could
materially adversely affect prospects for the Company's success.
Product Liability; Availability of Insurance
The Company currently has in force general liability insurance, with
coverage limits of $2.0 million per incident and $4.0 million in the aggregate
annually, and product liability insurance with coverage limits of $1.0 million
per incident and $3.0 million in the aggregate annually. The Company's insurance
policies provide coverage for product liability on a claims made basis and
general liability on an occurrence basis. These policies are subject to annual
renewal. Such insurance may not be available in the future on acceptable terms
or at all. There can be no assurance that the Company's insurance coverage will
be adequate or that a product liability claim or recall would not materially
adversely affect the business or financial condition of the Company.
The use of the Company's potential products or technology in clinical
trials and the sale of such products may expose the Company to liability claims.
Such risks exist even with respect to those potential products, if any, that
receive regulatory approval for commercial sale. Although Celtrix has taken and
will continue to take what it believes are appropriate precautions, there can be
no assurance that it will avoid significant product liability exposure. There
also can be no assurance that the Company's insurance coverage will be adequate
or that a product liability claim or recall would not materially adversely
affect the business or financial condition of the Company.
Environmental Liability
The Company is subject to federal, state and local laws and regulations
governing the use, generation, manufacture, storage, discharge, handling and
disposal of certain materials and wastes used in its operations. There can be no
assurance that the Company will not be required to incur significant costs to
comply with environmental laws and regulations as its research activities are
increased, or that the operations, business and future profitability of the
Company will not be adversely affected by current or future environmental laws
and regulations.
Concentration of Stock Ownership
The Company's directors and officers and their affiliates beneficially own
approximately 30% of the outstanding Common Stock. As a result, these
stockholders will be able to exercise significant influence over all matters
requiring stockholder approval, including the election of directors and approval
of significant corporate transactions. Such concentration of ownership may have
the effect of delaying or preventing a change in control of the Company.
10
12
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of Common Stock by
the Selling Stockholders in the Offering.
INDEMNIFICATION OF OFFICERS AND DIRECTORS
Section 145 of the Delaware General Corporation Law authorizes a court to
award, or a corporation's Board of Directors to grant, indemnity to directors
and officers in terms sufficiently broad to permit such indemnification under
certain circumstances for liabilities (including reimbursement for expenses
incurred) arising under the Securities Act of 1933, as amended (the "Securities
Act"). Section 10 of the Company's Amended and Restated Certificate of
Incorporation and Article VI of the Company's Bylaws provide for indemnification
of its directors, officers, employees and other agents to the maximum extent
permitted by law. In addition, the Company has entered into Indemnification
Agreements with its officers and directors and maintains director and officer
liability insurance.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the Company has
been advised that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act and
is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Company of expenses
incurred or paid by a director, officer or controlling person of the Company in
the successful defense of any action, suit or proceeding) is asserted against
the Company by such director, officer or controlling person in connection with
the securities being registered hereunder, the Company will, unless in the
opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities
Act and will be governed by the final adjudication of such issue.
ISSUANCE OF COMMON STOCK AND WARRANTS TO SELLING STOCKHOLDERS
On August ___, 1998, the Company will privately place __________ shares of
its Common Stock and warrants to purchase _____________ shares of its Common
Stock to the Selling Stockholders pursuant to the terms of Common Stock and
Warrant Purchase Agreements dated as of August ___, 1998 by and between the
Company and the Selling Stockholders. This Prospectus covers the ___________
shares of the Company's Common Stock issued (or issuable upon exercise of the
Warrants issued) in the Private Placement to the Selling Stockholders.
PLAN OF DISTRIBUTION
The Selling Stockholders may sell the Shares in whole or in part, from time
to time on the over-the-counter market at prices and on terms prevailing at the
time of any such sale. Any such sale may be made in broker's transactions
through broker-dealers acting as agents, in transactions directly with market
makers or in privately negotiated transactions where no broker or other third
party (other than the purchaser) is involved. The Selling Stockholders will pay
selling commissions or brokerage fees, if any, with respect to the sale of the
Shares in amounts customary for the type of transaction effected. Each Selling
Stockholder will also pay all applicable transfer taxes and all fees and
disbursements of counsel for such Selling Stockholder incurred in connection
with the sale of shares.
11
13
Each Selling Stockholder has advised the Company that before or during such
time as such Selling Stockholder may be engaged in the attempt to sell Shares
registered hereunder, such person will:
(i) notify the Company of its intent to sell any Shares at least three (3)
full business days prior to such sale; and
(ii) cause to be furnished to each person to whom Shares included herein
may be offered, and to each broker-dealer, if any, through whom Shares are
offered, such copies of this Prospectus, as supplemented or amended, as may be
required by such person.
The Selling Stockholders, and any other persons who participate in the sale
of the Shares, may be deemed to be "Underwriters" as defined in the Securities
Act. Any commissions paid or any discounts or concessions allowed to any such
persons, and any profits received on resale of the Shares, may be deemed to be
underwriting discounts and commissions under the Securities Act.
The Company has agreed to maintain the effectiveness of this Registration
Statement until the earlier of the sale of all the Shares registered pursuant to
this Prospectus or such date as the Company shall be satisfied that each holder
of Shares can sell all of the Shares it holds in any three-month period in
compliance with Rule 144 promulgated under the Securities Act, but in no event
after _____, 200_. No sales may be made pursuant to this Prospectus after such
date unless the Company amends or supplements this Prospectus to indicate that
it has agreed to extend such period of effectiveness.
The Company has agreed to indemnify the Selling Stockholders against
certain liabilities, including liabilities under the Securities Act.
12
14
The following table sets forth certain information as of August ___, 1998
with respect to the Selling Stockholders:
SHARES BENEFICIALLY SHARES OF SHARES BENEFICIALLY
OWNED PRIOR COMMON STOCK OWNED AFTER
TO THE OFFERING THE OFFERING(1)(2)
------------------------ OFFERED ------------------------
NAME OF SELLING STOCKHOLDER NUMBER PERCENT HEREBY NUMBER PERCENT
- -------------------------------------------- ------ ------- ------- ------ -------
[Information To Be Provided]
--------- --------- --------- --------- ---------
TOTAL 9,000,000
- ------------
* Less than 1%
(1) Information with respect to beneficial ownership is based upon information
contained in filings made by certain Selling Stockholders with the
Securities and Exchange Commission, and information obtained from the
Company's transfer agent and certain of the Selling Stockholders.
(2) Assumes sale of all Shares, including shares issuable upon exercise of
Warrants hereto, offered hereby and no other purchases or sales of the
Company's Common Stock. See "Plan of Distribution."
No Selling Stockholder has had any material relationship with the Company
or any of its predecessors or affiliates within the last three years.
13
15
LEGAL MATTERS
Certain legal matters with respect to the legality of the issuance of the
Common Stock offered hereby will be passed upon for the Company by Venture Law
Group, A Professional Corporation, 2800 Sand Hill Road, Menlo Park, California
94025. Craig W. Johnson, a director of Venture Law Group, is Secretary of the
Company. As of the date of this Prospectus, certain partners of Venture Law
Group beneficially own 19,500 shares of the Company's Common Stock.
EXPERTS
The consolidated financial statements of Celtrix Pharmaceuticals, Inc.
appearing in the Company's Annual Report (Form 10-K) for the year ended March
31, 1998 have been audited by Ernst & Young LLP, independent auditors, as set
forth in their report thereon included therein (which contains an explanatory
paragraph with respect to the Company's ability to continue as a going concern
mentioned in Note 1 to the consolidated financial statements) and incorporated
herein by reference. Such consolidated financial statements are incorporated
herein by reference in reliance upon such report given upon the authority of
such firm as experts in accounting and auditing.
ADDITIONAL INFORMATION
This Prospectus constitutes a part of the Registration Statement on Form
S-3 (herein, together with all amendments and exhibits, referred to as the
"Registration Statement") filed by the Company with the Securities and Exchange
Commission (the "Commission") under the Securities Act. This Prospectus does not
contain all of the information set forth in the Registration Statement, certain
parts of which are omitted in accordance with the rules and regulations of the
Commission. For further information with respect to the Company and the shares
of Common Stock offered hereby, reference is hereby made to the Registration
Statement. Statements contained herein concerning the provisions of any document
are not necessarily complete, and each such statement is qualified in its
entirety by reference to the copy of such document filed with the Commission.
14
16
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses payable by the
Registrant in connection with the sale and distribution of the Common Stock
being registered. Selling commissions and brokerage fees and any applicable
transfer taxes and fees and disbursements of counsel for the Selling
Stockholders are payable individually by the Selling Stockholders. All amounts
are estimates except the registration fee.
AMOUNT
TO BE PAID
----------
Registration Fee..................................... $ 4,000
Legal Fees and Expenses.............................. 40,000
Accounting Fees and Expenses......................... 25,000
Finders Fee (in connection with private placement)...
--------
Miscellaneous...................................... 20,000
--------
Total....................................... $
========
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145 of the Delaware General Corporation Law ("DGCL") provides a
detailed statutory framework covering indemnification of officers and directors
against liabilities and expenses arising out of legal proceedings brought
against them by reason of their being or having been directors or officers.
Section 145 generally provides that a director or officer of a corporation (i)
shall be indemnified by the corporation for all expenses of such legal
proceedings when he is successful on the merits, (ii) may be indemnified by the
corporation for the expenses, judgments, fines and amounts paid in settlement of
such proceedings (other than a derivative suit), even if he is not successful on
the merits, if he acted in good faith and in a manner he reasonably believed to
be in or not opposed to the best interests of the corporation, and, with respect
to any criminal action or proceeding, had no reasonable cause to believe his
conduct was unlawful, and (iii) may be indemnified by the corporation for the
expenses of a derivative suit (a suit by a stockholder alleging a breach by a
director or officer of a duty owed to the corporation), even if he is not
successful on the merits, if he acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the
corporation. No indemnification may be made under clause (iii) above, however,
if the director or officer is adjudged liable for negligence or misconduct in
the performance of his duties to the corporation, unless a corporation
determines that, despite such adjudication, but in view of all the
circumstances, he is entitled to indemnification. The indemnification described
in clauses (ii) and (iii) above may be made only upon a determination that
indemnification is proper because the applicable standard of conduct has been
met. Such determination may be made by a majority of a quorum of disinterested
directors, independent legal counsel, the stockholders or a court of competent
jurisdiction.
Section 102(b)(7) of the DGCL permits a corporation to provide in its
certificate of incorporation that a director of the corporation shall not be
personally liable to the corporation or its stockholders for monetary damages
for breach of fiduciary duty as a director, except for liability (i) for any
breach of the director's duty of loyalty to the corporation or its stockholders,
(ii) for acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL,
or (iv) for any transaction from which the director derived an improper personal
benefit. Section 10 of the Registrant's Amended and Restated Certificate of
Incorporation and Article IV of the Registrant's Bylaws provide for
indemnification of its directors, officers, employees and other agents to
II-1
17
the maximum extent permitted by law. In addition, the Registrant has entered
into Indemnification Agreements with its officers and directors pursuant to
which the Company has agreed to indemnify such individuals to the fullest extent
permitted by Delaware law, and maintains director and officer liability
insurance.
ITEM 16. EXHIBITS
EXHIBIT
NUMBER DESCRIPTION OF EXHIBIT
------- ------------------------------------------------
4.4 Form of Warrant of Registrant dated August ___,
1998.
5.1 Opinion of Venture Law Group, A Professional
Corporation
10.50 Form of Common Stock and Warrant Purchase
Agreement dated as of August ___, 1998 by and
among the Company and each Selling Stockholder
23.1 Form of Consent of Ernst & Young LLP,
Independent Auditors
23.2 Form of Consent of Counsel (included in Exhibit
5.1)
24.1 Power of Attorney (see page II-4)
- ------------
ITEM 17. UNDERTAKINGS
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement to include any material
information with respect to the plan of distribution not previously disclosed in
the Registration Statement or any material change to such information in the
Registration Statement.
(2) That, for the purpose of determining any liability under the Securities
Act of 1933, each such post-effective amendment shall be deemed to be a new
registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the termination of the
offering.
(4) That, for purposes of determining any liability under the Securities
Act of 1933, each filing of the Registrant's annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan's annual report pursuant to
Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by
reference in the Registration Statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the provisions referred to in Item
II-2
18
15 above or otherwise, the Registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is against public
policy as expressed in the Securities Act of 1933 and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the Registrant of expenses incurred or
paid by a director, officer or controlling person of the Registrant in the
successful defense of any action, suit or proceeding) is asserted against the
Registrant by such director, officer or controlling person in connection with
the securities being registered hereunder, the Registrant will, unless in the
opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities
Act of 1933 and will be governed by the final adjudication of such issue.
II-3
19
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements for filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Santa Clara, State of California, on the 18th day of
August 1998.
CELTRIX PHARMACEUTICALS, INC.
By: /s/ Andreas Sommer
-------------------------------------
Andreas Sommer, President and
Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below hereby constitutes and appoints, Andreas Sommer and Donald D.
Huffman, and each of them acting individually, as his attorney-in-fact, each
with full power of substitution, for him in any and all capacities, to sign any
and all amendments to this Registration Statement (including post-effective
amendments), and to file the same, with exhibits thereto and other documents in
connection therewith, with the Securities and Exchange Commission, hereby
ratifying and confirming our signatures as they may be signed by our said
attorney to any and all amendments to said Registration Statement. Pursuant to
the requirements of the Securities Act of 1933, this Registration Statement has
been signed by the following persons in the capacities and on the dates
indicated:
SIGNATURE TITLE DATE
--------- ----- ----
/s/ Andreas Sommer President, Chief Executive Officer and August 18, 1998
- ---------------------------------------- Director
(Andreas Sommer) (Principal Executive Officer)
/s/ Donald D. Huffman Vice President, Finance and Administration August 18, 1998
- ---------------------------------------- and
(Donald D. Huffman) Chief Financial Officer
(Principal Financial and Accounting Officer)
/s/ Henry E. Blair Director August 18, 1998
- ----------------------------------------
(Henry E. Blair)
/s/ Barry M. Sherman Director August 18, 1998
- ----------------------------------------
(Barry M. Sherman)
/s/ James E. Thomas Chairman of the Board of Directors August 18, 1998
- ----------------------------------------
(James E. Thomas)
II-4
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CELTRIX PHARMACEUTICALS, INC.
INDEX TO EXHIBITS
EXHIBIT
NUMBER
-------
4.5 Form of Warrant of Registrant dated August ___,
1998
5.1 Opinion of Venture Law Group, A Professional
Corporation
10.55 Form of Common Stock and Warrant Purchase Agreement as of August
___, 1998 between the Company and each of the Selling
Stockholders
23.1 Form of Consent of Ernst & Young LLP, Independent Auditors
23.2 Form of Consent of Counsel (included in Exhibit 5.1)
24.1 Power of Attorney (see page II-4)