Filed pursuant to 424(b)(1)
Registration No. 333-63255
ALLIANCE PHARMACEUTICAL CORP.
SHARES OF COMMON STOCK
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This Prospectus relates to shares (the "Shares") of Common Stock, $.01
par value (the "Common Stock"), which may be offered by certain shareholders of
the Company (the "Selling Shareholders") from time to time directly or through
one or more broker-dealers, in one or more transactions on the Nasdaq National
Market ("Nasdaq"), otherwise in the over-the-counter market, in negotiated
transactions or otherwise, or through a combination of such methods, at fixed
prices, which may be changed, at market prices prevailing at the time of sale,
at prices related to such prevailing market prices or at negotiated prices.
The Shares may be issued to the Selling Shareholders as the result of
the conversion of up to 100,000 Shares of the Company's Series E-1 Convertible
Preferred Stock (the "Series E-1 Preferred") into shares of Common Stock. The
maximum number of shares of Common Stock which may be issued to the Selling
Shareholders will be based on and subject to the assumptions set forth under
"Selling Shareholders." See "Selling Shareholders."
None of the proceeds of the sale of the Shares by the Selling
Shareholders will be received by the Company. The Company has agreed to bear all
expenses (other than underwriting discounts and selling commissions, and fees
and expense of advisers to the Selling Shareholders) in connection with the
registration of the Shares. The Shares offered pursuant to this Prospectus may
be issued in one or more issuances.
The Company's Common Stock is listed on Nasdaq under the symbol ALLP.
On January 4, 1999, the closing price of the Common Stock as quoted on Nasdaq
was $3.25 per share.
THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK. SEE
"RISK FACTORS" BEGINNING ON PAGE 8 HEREOF.
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NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR PASSED UPON THE ACCURACY OR ADEQUACY OF
THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY
IS A CRIMINAL OFFENSE.
The date of this Prospectus is January 6, 1999.
NO PERSON IS AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS,
OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS, IN CONNECTION WITH THE OFFERING
DESCRIBED HEREIN, AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS
MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY OR ANY SELLING
STOCKHOLDER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL, OR A
SOLICITATION OF AN OFFER TO BUY, NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
BY ANY PERSON IN ANY JURISDICTION IN WHICH IT IS UNLAWFUL FOR SUCH PERSON TO
MAKE SUCH OFFER, SOLICITATION OR SALE. NEITHER THE DELIVERY OF THIS PROSPECTUS
NOR ANY SALE MADE HEREUNDER SHALL UNDER ANY CIRCUMSTANCES CREATE AN IMPLICATION
THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO
THE DATE HEREOF.
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The Company's Annual Report on Form 10-K for the fiscal year ended
June 30, 1998, and the Company's Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 1998 which were filed with the Securities and
Exchange Commission (the "Commission") pursuant to the Securities Exchange Act
of 1934, as amended (the "Exchange Act"), and the information under the caption
"Description of the Company's Securities" contained in the Company's
Registration Statement on Form 8-A, dated October 25, 1984, with respect to the
Company's Common Stock, are incorporated herein by reference and made a part of
this Prospectus as of the date hereof. All reports subsequently filed pursuant
to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the
termination of the offering of the Shares offered hereby shall be deemed to be
incorporated by reference into this Prospectus. Any statement contained herein
or in a document incorporated or deemed to be incorporated by reference herein
shall be deemed to be modified or superseded for purposes of this Prospectus to
the extent that a statement contained herein or in any document which is or is
deemed to be incorporated by reference herein modifies or supersedes such
statement. Any statement so modified or superseded shall not be deemed, except
as so modified or superseded, to constitute a part of this Prospectus.
The Company will provide without charge to any person to whom this
Prospectus is delivered, upon written or oral request of such person, a copy of
any or all of the documents which have been incorporated by reference in this
Prospectus, other than exhibits to such documents, unless such exhibits are
specifically incorporated by reference into the documents so incorporated.
Requests for such copies should be directed to Lloyd Rowland, Secretary and
General Counsel, Alliance Pharmaceutical Corp., 3040 Science Park Road, San
Diego, California 92121, telephone (619) 558-4300.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Exchange Act and in accordance therewith files reports, proxy statements and
other information with the Commission. Such reports, proxy statements and other
information can be inspected and copied at the public reference facilities of
the Commission, Room 1024, Judiciary Plaza, 450 Fifth Street, N.W, Washington,
D.C. 20549, and at the Commission's New York Regional Office, Seven World Trade
Center, 13th Floor, New York, New York 10048, and at its Chicago Regional
Office, Northwestern Atrium Center, 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661, and copies of such materials can be obtained by mail
from the Public Reference Section of the Commission at 450 Fifth Street, N.W,
Washington, D.C. 20549, at prescribed rates. They are also available through the
Commission's World Wide Web site (http://www.sec.gov). The Company's Common
Stock is listed on Nasdaq. Reports and other information concerning the Company
may be inspected at the offices of the National Association of Securities
Dealers, Inc. at 1735 K Street, N.W., Washington, D.C. 20006.
ADDITIONAL INFORMATION
This Prospectus constitutes a part of a 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 under the Securities Act of 1933, as amended (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 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.
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PROSPECTUS SUMMARY
The following summary is qualified in its entirety by, and should be
read in conjunction with, the more detailed information and consolidated
financial statements in this Prospectus or previously filed with the Commission
and incorporated herein by reference. As used in this Prospectus, the terms
"Company" and "Alliance" refer to Alliance Pharmaceutical Corp. and the
consolidated subsidiaries of Alliance Pharmaceutical Corp., unless the context
indicates otherwise.
The Company
Alliance Pharmaceutical Corp. (the "Company" or "Alliance") is a
pharmaceutical research and development company that focuses on developing
scientific discoveries into medical products and licensing these products to
multinational pharmaceutical companies in exchange for fixed payments and
royalties. To date, the Company has developed three innovative products through
initial clinical (human) trials, and is in pivotal clinical trials for these
products. The products are Oxygent(TM), an intravascular oxygen carrier to
temporarily augment oxygen delivery in surgical and other patients at risk of
acute tissue hypoxia (oxygen deficiency); LiquiVent(R), an intrapulmonary agent
for use in reducing a patient's exposure to the harmful effects of conventional
mechanical ventilation; and Imagent(R), an intravenous contrast agent for
enhancement of ultrasound images to assess cardiac function and myocardial
perfusion and to detect blood flow abnormalities, which is licensed to Schering
AG, Germany.
The Company's strategy is to identify potential new medical products
through scientific collaborations with researchers and clinicians in
universities and medical centers where many of the basic causes of disease and
potential targets for new therapies are discovered. Using its experience in
defining pharmaceutical formulations, designing manufacturing processes,
conducting preclinical pharmacology and toxicology studies, and conducting human
testing, Alliance endeavors to advance such discoveries into clinical
development. The Company seeks collaborative relationships for the final stages
of product development, including completing late-phase human testing, obtaining
worldwide regulatory approvals, building large-scale manufacturing capacities,
and marketing.
Products in Clinical Development
Three of Alliance's products are currently in late-stage clinical
development. These are Oxygent, LiquiVent, and Imagent, which are based upon
perfluorochemical ("PFC") and emulsion technologies. PFCs are biochemically
inert compounds and may be employed in a variety of therapeutic and diagnostic
applications. The Company's primary drug substance is perflubron, a brominated
PFC that has a high solubility for respiratory gases and can be used to
transport these gases safely throughout the body. The Company also has a fourth
product, RODA(TM), a device intended to measure the cardiovascular and
oxygenation status of patients, which is in clinical development.
Oxygent. Oxygent (perflubron emulsion) is an intravascular oxygen delivery
system to temporarily augment oxygen delivery in surgical and other patients at
risk of acute tissue oxygen deficit. It will be used as a temporary oxygen
carrier to provide oxygen to tissues during elective surgeries where substantial
blood loss is anticipated.
In fiscal 1997, two large multicenter Phase II clinical studies of
Oxygent were completed in general surgery patients in the United States and
Europe. In fiscal 1998, three additional Phase II studies were completed in
which Oxygent was administered to cardiac surgery patients undergoing
cardiopulmonary bypass procedures. In November 1998, a Phase III clinical trial
in general surgery patients was started in Europe. The Company intends to begin
a similar Phase III clinical trial in the U.S. in the near future.
In August 1994, the Company entered into a license agreement (the
"Ortho License Agreement"), with Ortho Biotech, Inc. and The R.W. Johnson
Pharmaceutical Research Institute, a division of Ortho Pharmaceutical
Corporation, both affiliates of Johnson & Johnson (collectively referred to as
"Ortho"), which provided Ortho with certain development and worldwide marketing
rights to the Company's injectable PFC emulsions capable of transporting oxygen
for therapeutic use, including Oxygent. In May 1998, because of disagreements as
to the scope and timing of further clinical development, including whether to
proceed with Phase III trials at that time and for which indications, Ortho and
Alliance restructured their agreement. Under the restructured agreement,
Alliance assumed responsibility for worldwide development of Oxygent at its own
cost, and Ortho has a limited right of first offer to enter into a development
or marketing or license agreement for Oxygent, which right may be repurchased by
Alliance for $2 million under certain circumstances.
LiquiVent. LiquiVent (neat perflubron) is an intrapulmonary agent for use in
reducing a patient's exposure to the harmful effects of conventional mechanical
ventilation.
In April 1997, the Company temporarily suspended enrollment in its
ongoing Phase III LiquiVent trial in pediatric patients to analyze an
unexplained, substantial decrease in the mortality rate for the control group
which occurred after a protocol amendment in December 1996. The decision was not
prompted by any LiquiVent-related adverse events. In August 1997, the Company
completed its analysis of data from the clinical trial. The Company found that
after the protocol amendment, patients in the post-amendment control group were
younger and had different disease etiologies compared to the pre-amendment
control group. Additionally, post-amendment control group patients received
additional therapies such as extracorporeal membrane oxygenation, high frequency
oscillatory ventilation, nitric oxide or surfactants more frequently, earlier,
and for a longer duration compared to both the pre-amendment control group and
the LiquiVent-treated patients. The study analysis also supported previous
reports that PLV therapy with LiquiVent is a safe procedure. In 1998, the
Company completed a small Phase II adult clinical trial intended to validate the
protocol for a subsequent pivotal trial with adult patients. The Company
initiated a Phase III clinical study in adult patients in November 1998.
In February 1996, the Company entered into a license agreement (the
"HMRI License Agreement") with Hoechst Marion Roussel, Inc. ("HMRI"), which
provided HMRI with worldwide marketing and manufacturing rights to the
intratracheal administration of liquids, including LiquiVent, which perform
bronchoalveolar lavage or liquid ventilation. The product was being developed
jointly by Alliance and HMRI. In June 1997, Alliance announced that the parties
agreed in principle to adjust certain milestone payments, to temporarily revise
the method for reimbursing expenses of the development work and to the terms to
repurchase clinical supplies sold, in conjunction with the April 1997 temporary
interruption of the clinical development program. In December 1997, HMRI
terminated the HMRI License Agreement and Alliance regained all rights to the
product. On September 25, 1998, Alliance received a demand for arbitration from
HMRI, claiming up to $16.8 million, plus interest and punitive damages, in
connection with the termination of the HMRI License Agreement. The Company has
filed a counter-claim against HMRI. The Company does not believe the claim is
meritorious, intends to contest such claim, and believes that the ultimate
resolution will not have a material adverse effect on the Company's financial
condition, results of operations or liquidity. However, no assurances can be
given that the Company will prevail on the claim or that an adverse result will
not have a material adverse effect on the Company.
Imagent. Imagent is an intravenous contrast agent for enhancement of ultrasound
images to assess cardiac function and myocardial perfusion, and to detect solid
organ lesions and blood flow abnormalities.
In March 1998, the Company initiated two Phase III clinical trials to
assess cardiac function. The multicenter trials are designed to demonstrate the
use of Imagent to aid in the evaluation of cardiac function as assessed by both
ejection fraction and endocardial border definition. A Phase II myocardial
perfusion feasibility study is also underway for assessment of blood flow
defects in the muscle of the heart. In July 1998, two Phase II prostate and
breast feasibility studies were initiated. Enrollment in a Phase II clinical
trial was completed in 1997 in adults undergoing diagnostic procedures for
evaluation of space-occupying lesions of the liver and kidney and vascular flow
abnormalities.
In September 1997, the Company entered into a license agreement (the
"Schering License Agreement") with Schering AG, Germany ("Schering"), which
provides Schering with worldwide exclusive marketing and manufacturing rights to
Alliance's drug compounds, drug compositions and medical devices and systems
related to perfluorocarbon ultrasound imaging products, including Imagent. The
product is being developed jointly by Alliance and Schering. In exchange for the
license, Schering paid Alliance a license fee of $4 million and will make
additional payments based upon the achievement of certain milestones. Royalty
payments will be based on worldwide sales. In addition, Schering Berlin Venture
Corp. purchased $10 million in Alliance convertible preferred stock, convertible
into Alliance common stock at a price to be determined by the market value of
the common stock at future dates. Schering made a $1 million milestone payment
in December 1997.
RODA. In July 1997, the Company entered into a development agreement (the "VIA
Development Agreement") with VIA Medical Corporation ("VIA") for the joint
development of RODA (Real-time Oxygen Dynamics Analyzer). RODA is an ex vivo
device intended to provide on-line measurements of the cardiovascular and
oxygenation status of patients by minimally invasive means. The device could
assist physicians in their decisions regarding transfusions and other
interventions. RODA will combine oxygen dynamics software designed by the
Company with VIA's ex vivo blood gas and chemistry monitor and other VIA
technology. The Company has conducted pilot clinical studies in the U.S. and
Europe to assess its oxygen dynamics software. VIA is currently developing an
engineering prototype of the final device to use for clinical testing and
regulatory submissions. In August 1998, Alliance and VIA entered into a
manufacturing, marketing and distribution agreement (the "VIA Marketing
Agreement") whereby VIA will be responsible for manufacturing and marketing RODA
and the parties will share revenues from the sale of products.
Other Products
PulmoSpheres(TM). PulmoSpheres are hollow, porous spheres (in powder form)
suspended in perflubron or fluorochemical propellants for the purpose of
pulmonary drug delivery. Drugs can be stabilized within the wall structure of
these respirable particles, which are typically 1-3 microns in diameter.
Laboratory and preclinical testing indicates that PulmoSphere formulations may
provide advantages over current formulation technologies with regard to particle
suspension stability and flow aerodynamics, which could enhance the efficiency
of pulmonary drug delivery.
Over the past year, different types of drugs have been successfully
formulated in PulmoSpheres for feasibility testing purposes. Drugs such as
bronchodilators and steriodal anti-inflammatory agents could potentially be
formulated in PulmoSpheres and delivered to the lung by way of standard
metered-dose inhaler ("MDI") devices for the topical treatment of asthma.
Alternatively, proteins or peptides intended for systemic distribution and
treatment of other chronic diseases might be incorporated into PulmoSpheres and
be delivered by other commonly used devices such as nebulizers or dry powder
inhalers, which tend to propel small particles deeper into the lung for improved
systemic uptake.
The current business strategy for PulmoSpheres involves Alliance
formulating the drugs and subsequently manufacturing bulk powders for
pharmaceutical company partners. The partners would be responsible for filling
the powders in delivery device(s), conducting preclinical and clinical trials,
and marketing the resultant products.
FloGel(R). In November 1996, Alliance acquired all of the stock of MDV
Technologies, Inc. ("MDV") for initial payments of $15.5 million over a one-year
period, with additional payments and royalties to the former MDV shareholders
upon the occurrence of certain clinical development, licensing, or
commercialization events. The Company is developing a thermoreversible gel,
FloGel, intended for use as an anti-adhesion treatment for patients undergoing
abdominal or pelvic surgeries. FloGel is applied in a cold liquid form and
becomes a gel at body temperature, forming a barrier between tissues.
Preliminary human safety data with a previous formulation for the product have
been obtained and, during the past year, preclinical studies have been performed
on additional formulations. The Company selected a formulation for a pilot
clinical trial which began in November 1998. In addition to the anti-adhesion
product, MDV also has patents covering the use of gels for drug delivery and
ophthalmic indications.
Other. The Company intends to consider other technologies that may be available
for licensing and research agreements with other institutions or inventors.
Alliance intends, where appropriate, to seek outside sources of funding. If new
license and research agreements are added and the Company is not able to obtain
outside sources of funding, the Company's losses from research and development
activities could increase significantly.
The Company's products require substantial development efforts. The
Company may encounter unforeseen technical and other problems which may force
delay, abandonment, or substantial change in the development of a specific
product or process, or technological change, or product development by others,
any of which may have a material adverse effect on the Company.
The address of the Company's corporate headquarters is 3040 Science
Park Road, San Diego, California 92121, and its telephone number is (619)
558-4300. The Company maintains a website at http://www.allp.com. The contents
of the Company's website shall not be deemed to constitute a part of this
Prospectus.
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RISK FACTORS
An investment in the Shares offered hereby involves a high degree of
risk. The following factors and cautionary statements should be carefully
considered in evaluating the Company and its business:
Limited Product Revenues; History of Operating Losses. Substantially
all of the Company's revenues to date have consisted of licensing fees,
milestone payments, and payments to fund research and development activities
under joint development and license agreements. The Company has had net
operating losses since its inception and expects such losses to continue unless
and until such time as revenues are sufficient to fund its continuing
operations. As of September 30, 1998, the Company had an accumulated deficit of
$274.9 million. For the years ended June 30, 1994, 1995, 1996, 1997 and 1998,
the Company incurred net losses of $36.9 million, $29.7 million, $23.2 million,
$19 million and $33 million, respectively. The Company's net loss for the
quarter ended September 30, 1998 was $10.7 million. There can be no assurance
that the Company will be able to achieve profitability at all or on a sustained
basis.
Future Capital Needs; Uncertainty of Additional Financing. The Company
believes that its existing capital resources, including expected revenues from
the Schering License Agreement and investments, together with the proceeds from
the recent private placement of shares of the Series E-1 Preferred, will be
adequate to satisfy its capital requirements for fiscal 1999. However, unless
and until the Company enters into collaborative arrangements for Oxygent and
LiquiVent and obtains reimbursement therefor, the high costs of planned
late-stage clinical trials for such products will be substantial and the
Company's funding requirements for such products are expected to increase
materially for the next two years, as compared to current levels. The Company
will need additional financing to support its long-term product development
programs. The Company's future capital requirements will depend on many factors,
including continued scientific progress in its research and development
programs, progress with preclinical testing and clinical trials, the time and
cost involved in obtaining regulatory approvals, patent costs, competing
technological and market developments, and changes in existing collaborative
relationships. If necessary, the Company may require additional financing to
establish development, sales, and marketing arrangements and to cover the cost
of manufacturing scale up, if necessary. No assurance can be given that adequate
financing will be available to the Company in the future or on terms acceptable
to the Company.
Reliance on Collaborative Partners; Future Collaborations. The Company
previously entered into license agreements to support the development and
commercialization of Oxygent, LiquiVent, and Imagent and to raise capital. On
December 5, 1997, the HMRI License Agreement for LiquiVent was terminated and
the Company assumed all responsibility for further development efforts and
funding therefor. On May 14, 1998, the Company announced that the license
agreement for Oxygent had been restructured. Beginning in August 1998, Alliance
assumed all responsibility for further Oxygent development efforts and funding
therefor, subject to Ortho retaining certain marketing rights. The Company has
also entered into the VIA Development Agreement for RODA. The Company's strategy
is to seek additional collaborations for LiquiVent, Oxygent, and its other
products. However, there can be no assurance that the Company will be able to
negotiate acceptable collaborative arrangements in the future, or that any
current or future arrangements will ultimately be successful. Under the Schering
License Agreement, the Company will depend on Schering for development and
regulatory approval of Imagent outside the United States, and worldwide
marketing of the product. Termination of the Schering License Agreement, which
can occur on at least one month's advance notice, or any other future
collaborative arrangement could adversely affect the Company's research,
development or, ultimately, product distribution plans. The Company's revenues
from milestone payments or sales of any product may depend in large part upon
the efforts and abilities of the collaborative partner to perform clinical
testing, to obtain regulatory approvals, and to manufacture and market the
product. The amount and timing of resources devoted to these activities will not
be completely within the Company's control. The collaborative partner will have
certain discretion in deciding whether to commercialize the product. There can
be no assurance that the corporate interests and motivations of the Company's
collaborative partners will remain consistent with those of the Company, or that
they will market the Company's products in a way or to the extent that the
Company will consider satisfactory. The exclusivity of the Company's
collaborative arrangements may prevent the Company from replacing one
collaborative partner with another that the Company might deem better suited to
its requirements.
Government Regulation; Uncertainties Related to Clinical Trial
Results. The production and marketing of the Company's products and its research
and development activities are subject to regulation for safety and efficacy by
numerous government authorities in the United States and other countries.
Clinical trials and the manufacturing and marketing of the Company's products
are subject to the testing and approval process of the U.S. Food and Drug
Administration ("FDA") and foreign regulatory authorities. The FDA and other
regulatory authorities require that the safety and efficacy of a drug be
supported by results from adequate and well-controlled clinical trials before
approval for commercial sale. If the results of the clinical trials of the
Company's products do not demonstrate the safety and efficacy of the products,
the Company will not be able to submit to the FDA a New Drug Application ("NDA")
(or an application for pre-market approval in the case of a device, such as
FloGel or RODA). Further, the results of preclinical testing and initial
clinical trials are not necessarily predictive of the safety and efficacy
results that will be obtained from large-scale Phase III clinical testing. There
can be no assurance that unacceptable side effects will not be discovered at any
time in the future. A number of companies have suffered significant setbacks in
advanced clinical trials, despite promising results in earlier trials. The rate
of completion of clinical trials of the Company's products is dependent upon,
among other factors, obtaining adequate clinical supplies and the rate of
patient recruitment. Patient recruitment is a function of many factors,
including the size of the patient population, the proximity of patients to
clinical sites and the eligibility criteria for the trial. Delays in planned
patient enrollment in clinical trials may result in increased costs, program
delays or both, which could have a material adverse effect on the Company. Even
if the Company believes the clinical trials demonstrate the safety and efficacy
of a product, the FDA and other regulatory authorities may not accept the
Company's assessment of the results. In either case, the Company may have to
conduct additional clinical trials in an effort to demonstrate the safety and
efficacy of the product. The process of obtaining regulatory clearances or
approvals is costly and time-consuming. The Company cannot predict how long
preclinical and clinical trials will take or whether they will be successful,
nor can the Company, although it believes that it is in compliance in all
material respects with all applicable regulations, predict how long the
necessary regulatory approvals or clearances will take. Therefore, there can be
no assurance that the necessary clearances or approvals will be obtained, or
obtained on a timely basis. Without acceptable results and regulatory approval,
the Company would not be able to commercialize its products, which would have a
material adverse effect on the Company. There can be no assurance that the
results of any of the Company's clinical trials will be favorable or that the
Company's products will obtain regulatory approval for commercialization. The
effect of governmental regulations which might arise from future legislative or
administrative action cannot be predicted.
Limited Manufacturing Capability and Experience and Availability of
Raw Materials. While the Company believes that it can produce materials for
clinical trials and the initial market launch for Oxygent and Imagent at its
existing San Diego facilities and for LiquiVent at its Otisville facility, it
may need to expand its commercial manufacturing capabilities for its products in
the future. This expansion may occur in stages, each of which would require
regulatory approval, and product demand could at times exceed supply capacity.
The Company has not selected a site for such expanded facilities and cannot
predict the amount it will expend for the construction of such facilities. There
can be no assurance as to when or whether the FDA will determine that such
facilities comply with Good Manufacturing Practices. The projected location and
construction of such facilities will depend on regulatory approvals, product
development, and capital resources, among other factors. The Company has not
obtained any regulatory approvals for its production facilities for these
products, nor can there be any assurance that it will be able to do so. The
Schering License Agreement requires the Company to manufacture Imagent at its
San Diego facility for a period of time after market launch and to sell the
product to Schering at a negotiated price. Schering will be responsible for
establishing production capacity beyond the maximum capacity of the San Diego
facility.
Some of the raw materials for the Company's products are available
from single sources. At times, one or more of these raw materials may be
available in limited quantities or not at all. If sufficient supplies of raw
materials are not available, the Company's ability to develop its products could
be materially adversely affected. The Company is currently negotiating with some
of these suppliers for long-term supply contracts for its raw materials;
however, there can be no assurance that the Company will be able to obtain
commitments for a long-term supply of these raw materials or on terms acceptable
to the Company.
Uncertainty of Development and Commercialization Efforts. The
Company's products require substantial development efforts. The Company or its
collaborative partners may encounter unforeseen technological or scientific
problems, including side effects, which may force abandonment or substantial
change in the development of a specific product or process, or technological
change or product developments by others, any of which may have a material
adverse effect on the Company. Further, even after successful technical
development and receipt of governmental approval, a product may not achieve
commercial success. To date, the Company has received regulatory approval for
the commercial sale of only one of its drug products, the sales of which were
discontinued due to limited revenue potential.
Unpredictability of Patent Protection; Proprietary Technology. The
Company believes that its success will depend largely on its ability to obtain
and maintain patent protection for its own inventions and licenses for the use
of patents owned by third parties. The Company has obtained patents covering
certain intermediate and high concentration PFC emulsions, patents related to
liquid ventilation, and patents covering certain stabilized microbubble
compositions, as well as other patents. The Company has filed, and when
appropriate will file, other patent applications with respect to its products
and processes in the United States and in foreign countries. There can be no
assurance, however, that the Company will develop any additional products and
processes which may be patentable or that any additional patents will be issued.
It is possible that patents issued to the Company or any patents licensed to the
Company may be challenged successfully, that the Company may infringe patents of
third parties unintentionally, and that the Company may have to alter its
products or manufacturing processes to take into account the patents of third
parties, causing delays in product development. Further, there can be no
assurances that the Company will be able to alter its products or manufacturing
processes to avoid third party patents, and it may be necessary to terminate the
development or commercialization of a product. Litigation, which could result in
a substantial cost to the Company, may be necessary to enforce any patents
issued to the Company and/or to determine the scope and validity of others'
proprietary rights. The Company also attempts to protect its proprietary
products and processes by relying on trade secret laws and non-disclosure and
confidentiality agreements with its employees and certain other persons who have
access to its products or processes. No assurance can be given that others will
not develop such products or processes independently or obtain access to such
products or processes. To the extent that others develop or obtain similar
products or processes, the Company's competitive position may be affected
adversely.
Lack of Sales and Marketing Capability. The Company does not have
internal marketing and sales capabilities. The Company's current strategy is for
its collaborative partners to market and sell any products which it successfully
develops for the market. Currently, Schering will be solely responsible for all
activities related to marketing and sales of Imagent. Should the Company have to
market and sell its products directly, the Company would need to develop a
marketing and sales force with technical expertise and distribution capability.
The creation of infrastructure to commercialize pharmaceutical products is an
expensive and time-consuming process. Alternatively, the Company could contract
with other pharmaceutical and/or healthcare companies with distribution systems
and direct sales forces. There can be no assurance that the Company will be able
to establish marketing and sales capabilities or be successful in gaining market
acceptance for its products. To the extent that 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 any such efforts will be successful.
Uncertainty of Third-Party Reimbursement. The Company's ability to
commercialize its products successfully will depend in part on the extent to
which appropriate reimbursement levels for the cost of the products and related
treatment are obtained from government authorities, private health insurers and
other organizations, such as health maintenance organizations ("HMOs").
Third-party payors are increasingly challenging the prices charged for medical
products and services. Also, the trend toward managed health care in the United
States, the growth of organizations such as HMOs, and legislative proposals to
reform healthcare and government insurance programs could significantly
influence the purchase of healthcare services and products, resulting in lower
prices and reducing demand for the Company's products. The cost containment
measures that healthcare providers are instituting and any healthcare reform
could affect the Company's ability to sell its products and may have a material
adverse effect on the Company. There can be no assurance that reimbursement in
the United States or foreign countries will be available for any of the
Company's products, that any reimbursement granted will be maintained, or that
limits on reimbursement available from third-party payors will not reduce the
demand for, or negatively affect the price of, the Company's products. The
unavailability or inadequacy of third-party reimbursement for the Company's
products would have a material adverse effect on the Company. The Company is
unable to forecast what additional legislation or regulation relating to the
healthcare industry or third-party coverage and reimbursement may be enacted in
the future, or what effect the legislation or regulation would have on the
Company's business.
Dependence Upon Key Personnel. The Company's success in developing
marketable products and achieving a competitive position will depend, in part,
on its ability to attract and retain qualified scientific and management
personnel. Competition for such personnel is intense, and no assurance can be
given that the Company will be able to attract and retain such personnel.
Scientific advisors to the Company are employed by or have consulting
arrangements with third parties which may conflict with their obligations to the
Company. The Company's anticipated growth and expansion will require additional
expertise and are expected to place additional demands on the Company's
management and financial resources.
Competition; Rapid Technological Change. Biotechnology and
pharmaceutical companies are highly competitive. There are many pharmaceutical
companies, biotechnology companies, public and private universities, and
research organizations actively engaged in research and development of products
that may be similar to, or seek to attack the same targets as, Alliance's
products. Many of the Company's existing or potential competitors have
substantially greater financial, technical, and human resources than the Company
and may be better equipped to develop, manufacture, and market products. These
companies may develop and introduce products and processes competitive with or
superior to those of the Company. In addition, other technologies or products
may be developed that have an entirely different approach or means of
accomplishing the intended purposes of the Company's products which might render
the Company's technology and products uncompetitive or obsolete. There can be no
assurance that the Company will be able to compete successfully.
Product Liability Claims and Uninsured Risks. Products or processes
that may be developed, licensed, or sold by the Company may expose the Company
to potential liability from claims by end-users of such products or of products
manufactured by such processes, or by manufacturers or others selling such
products, either directly or as a component of other products. The Company
currently maintains limited product liability insurance coverage. There can be
no assurance that the Company will be able to maintain such coverage or obtain
additional coverage on acceptable terms, or that such insurance will provide
adequate coverage against all potential claims.
Volatility of Stock Price; Liquidation Preference; and Lack of
Dividends. Historically, the market prices for securities of biopharmaceutical
companies have been highly volatile. Announcements concerning the Company or its
competitors, including the results of testing and clinical trials, technological
innovations, or commercial products, government regulations, developments
concerning proprietary rights, including patents and litigation matters, a
change in status of a collaborative partner, public concern relating to the
commercial value or safety of the Company's products, and stock market
conditions in general have in the past and may in the future have a significant
impact on the price of the Company's Common Stock. Further, the stock market has
in recent months experienced and may continue to experience significant price
and volume fluctuations that particularly affect the market prices of equity
securities of many biopharmaceutical companies and that often are unrelated or
disproportionate to the operating performance of such companies.
The Company currently has 500,000 shares of Series D Preferred Stock
outstanding entitled to a liquidation preference of $20 per share. The Company
also has 100,000 shares of the Series E-1 Preferred outstanding entitled to a
liquidation preference of $60 per share.
The Company has not paid dividends on its Common Stock since its
inception and does not intend to pay any such dividends in the foreseeable
future. The Board of Directors of the Company will have the authority to issue
up to 2,900,000 additional shares of preferred and to determine the rights,
preferences, privileges and restrictions of such shares without any further vote
or action by the shareholders. The rights of the holders of Common Stock (and
any outstanding shares of preferred stock) will be subject to, and may be
adversely affected by the rights of the holders of any preferred stock that may
be issued in the future. The possible issuance of preferred stock could have the
effect of delaying, deferring or preventing a change in control of the Company.
The conversion and other features of any series of preferred stock may also
limit the price that investors might be willing to pay in the future for shares
of the Company's Common Stock. See "Risks Associated with Preferred Stock
Financing."
Shares Eligible for Future Sale. As of January 4, 1999, 6,274,325
shares of Common Stock (or 16% of the total number of shares outstanding on a
fully diluted basis) were issuable upon the exercise of outstanding options and
warrants. Additional shares may be issued upon the conversion of preferred
stock. Also, the Company may issue an indeterminate number of additional shares
of Common Stock to the former shareholders of a company acquired by Alliance in
1996 over a period estimated by the Company to be approximately four years. The
existence of such warrants, options and convertible securities, and the
Company's obligations as a result of the acquisition of MDV, as well as certain
registration rights, may adversely affect the terms on which the Company may
obtain additional equity financing. The holders of the outstanding warrants and
options are likely to exercise their securities at a time when the Company would
otherwise be able to obtain capital on terms more favorable than those provided
by the exercise or conversion prices thereof.
Risks Associated with Preferred Stock Financing. In August 1998, the
Company raised net proceeds of $6 million through the issuance of the Series E-1
Preferred. Certain protective provisions set forth in the Convertible Preferred
Stock Purchase Agreement dated August 13, 1998 (the "Purchase Agreement"), among
the Company and the Selling Shareholders, prohibit the Company, without the
consent of holders of all of the outstanding Series E Preferred Stock, from (a)
amending its certificate of incorporation, bylaws or other charter documents so
to adversely affect any rights of any holder of the Series E Preferred Stock;
(b) declaring, authorizing or setting aside or paying any dividend or other
distribution with respect to the Common Stock, except as permitted under the
Certificate of Designation (as defined below) and as would not adversely affect
the rights of any holder of the Series E Preferred Stock; (c) repaying,
repurchasing or offering to repay, repurchase or otherwise acquire shares of its
Common Stock in any manner; (d) issuing any series of preferred stock or other
securities with rights senior (in respect of liquidations, dividends,
preferences and similar rights) to those of the Series E Preferred Stock; or (e)
entering into any agreement with respect to the foregoing. Provisions of the
Certificate of Amendment to the Certificate of Incorporation (the "Certificate
of Designation"), filed in connection with the issuance of the Series E-1
Preferred also include certain penalty provisions that are triggered in the
event the Company fails to satisfy certain obligations. In the event the Company
fails to satisfy certain obligations, including the obligation to issue shares
of Common Stock upon conversion of the Series E-1 Preferred within specified
periods, substantial financial penalties may be imposed on the Company. There
can be no assurances that the Company will be able to fund such penalties, and
even if funding is available, the payment required to fund such penalties could
have an adverse effect on the Company's business and financial condition.
The Series E-1 Preferred is convertible into shares of the Company's
Common Stock based on the trading prices of the Common Stock during future
periods that are described in the Certificate of Designation. The number of
shares of Common Stock that may ultimately be issued upon conversion is
therefore presently indeterminable. If, in accordance with the terms of the
Certificate of Designation, the conversion price of the Series E-1 Preferred is
determined during a period when the trading price of the Common Stock is low,
the resulting number of shares of Common Stock issuable upon conversion of the
Series E-1 Preferred could result in substantial dilution to the holders of the
Common Stock.
Year 2000 Compliance. The Company recognizes the need to ensure that
its operations will not be adversely impacted by Year 2000 hardware and software
issues. The Company intends to use its best efforts to confirm its compliance
regarding Year 2000 issues for both internal and external information systems.
This process will entail communicating with significant suppliers, financial
institutions, insurance companies, and other parties that provide significant
services to the Company. Expenditures required to make the Company Year 2000
compliant are not expected to be material to the Company's consolidated
financial position or results of operations. No assurances can be given that the
Company's systems or the systems of other parties will be in compliance. A
failure of such systems to be free of Year 2000 issues could have a material
adverse effect on the Company.
The cautionary statements set forth above and elsewhere in this Prospectus, as
well as those set forth in the documents incorporated by reference herein,
should be read as accompanying forward-looking statements included under this
Prospectus and in such incorporated documents. The risks described in such
statements could cause the Company's results to differ materially from those
expressed in or indicated by such forward-looking statements.
PLAN OF DISTRIBUTION
The Shares may be offered by the Selling Shareholders upon conversion
of the Series E-1 Preferred from time to time directly or through one or more
broker-dealers, in one or more transactions on Nasdaq, otherwise in the
over-the-counter market, in negotiated transactions or otherwise, or through a
combination of such methods, at fixed prices, which may be changed, at market
prices prevailing at the time of sale, at prices related to such prevailing
market prices or at negotiated prices. The shares may be sold by the Selling
Shareholders by one or more of the following methods, without limitation: (a)
block trades in which the broker or dealer so engaged will attempt to sell the
Shares as agent but may position and resell a portion of the block as principal
to facilitate the transaction, (b) purchases by a broker or dealer as principal
and resale by such broker or dealer for its account pursuant to this Prospectus,
(c) an exchange distribution in accordance with the rules of the applicable
exchange, (d) ordinary brokerage transactions and transactions in which the
broker solicits purchases, (e) privately negotiated transactions, (f) short
sales and (g) a combination of any such methods of sale.
From time to time the Selling Shareholders may engage in short sales,
short sales against the box, puts and calls and other transactions in securities
of the Company or derivatives thereof, and may sell and deliver the Shares in
connection therewith or in settlement of securities loans. If the Selling
Shareholders engage in such transactions, the applicable conversion price may be
affected. From time to time the Selling Shareholders may pledge their Shares
pursuant to the margin provisions of its customer agreements with its brokers.
Upon a default by the Selling Shareholders, the broker may offer and sell the
pledged Shares from time to time.
The Selling Shareholders may sell the Shares to or through
broker-dealers or underwriters, and such broker-dealers or underwriters may
receive compensation in the form of discounts, concessions or commissions from
the Selling Shareholders and/or the purchasers of the Shares for which such
broker-dealers may act as agent or to whom they sell as principal, or both
(which compensation as to a particular broker-dealer may be in excess of
customary compensation). None of the proceeds of the sale of the Shares by the
Selling Shareholders will be received by the Company. The Selling Shareholders
may also sell the Shares in accordance with Rule 144 under the Securities Act,
rather than pursuant to this Prospectus.
The Selling Shareholders and broker-dealers or underwriters that
participate with the Selling Shareholders in the sale of the Shares may be
deemed to be "underwriters" within the meaning of the Securities Act, in which
event any discounts, concessions or commissions received by such broker-dealers
or underwriters and any profit on the resale of the Shares purchased by them may
be deemed to be underwriting commissions or discounts under the Securities Act.
To the extent required, the number of Shares to be sold, the purchase price, the
name of any such broker-dealer or underwriter and any applicable discounts,
concessions or commissions with respect to a particular offer will be set forth
in an accompanying Prospectus Supplement.
The Company is required to pay all fees and expenses incident to the
registration of the Shares, including fees and disbursements (subject to certain
limitations) of counsel to the Selling Shareholders. The Company has agreed to
indemnify the Selling Shareholders and each underwriter and broker who
participates in the offering of the Shares, against certain civil liabilities
including liabilities under the Securities Act and the Exchange Act.
<PAGE>
SELLING SHAREHOLDERS
The Selling Shareholders received or will receive the Shares upon
conversion of the shares of Series E-1 Preferred. There is no assurance that the
Selling Shareholders will sell any or all of the Shares offered hereby.
The following table sets forth the aggregate number of Shares held by
each Selling Shareholder and offered by each Selling Shareholder hereunder and
the percentage of all shares of Common Stock held by such Selling Stockholder
after giving effect to the offering (based on 32,042,482 shares of Common Stock
outstanding as of September 4, 1998). The number of Shares set forth in the
table below is based on the Series E-1 Preferred conversion price at January 4,
1999 of $2.63 per share of Common Stock issuable upon conversion of the shares
of the Series E-1 Preferred held by the Selling Shareholders.
<TABLE>
<CAPTION>
Number Percentage of
Number of Number of of Common Stock
Shares of Shares of Shares Owned After
Selling Series E-1 Common Stock (1) to be Offering (2)
Shareholders Preferred Offered
<S> <C> <C> <C> <C>
Brown Simpson 9,999 228,114 72,322 -
Strategic Growth
Fund, Ltd.
Brown Simpson 4,998 114,023 36,150 -
Strategic Growth
Fund, L.P.
Westover 4,833 110,259 34,957 -
Investments L.P.
Montrose 9,000 205,323 65,096 -
Investments Ltd.
Bay Harbor 23,333 532,312 168,766 -
Investments, Inc.
(1) Based on the conversion price at January 4, 1999 of $2.63 per share of
Common Stock issuable upon conversion of the Series E-1 Preferred.
(2) Because the Selling Shareholders may offer all or some of the Shares
pursuant to the offering contemplated by this Prospectus, no estimate
can be given as to the amount of shares of Common Stock that will be
held by the Selling Shareholders after completion of this offering.
</TABLE>
<PAGE>
LEGAL OPINION
The legality of the issuance of the shares of Common Stock offered
hereby will be passed upon for the Company by Stroock & Stroock & Lavan LLP.
EXPERTS
The consolidated financial statements of Alliance Pharmaceutical Corp.
and its subsidiaries appearing in the Company's Annual Report (Form 10-K) for
the year ended June 30, 1998, have been audited by Ernst & Young LLP,
independent auditors, as set forth in their report thereon included therein 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.
