Filed Pursuant to
Rule 424(b)(3)
File No. 333-33552
Prospectus
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ORPHAN MEDICAL, INC.
1,365,000 Shares
Common Stock
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This prospectus covers the sale of up to 1,365,000 shares of common stock of
Orphan Medical, Inc. offered for the account of certain selling shareholders. We
will not receive any part of the proceeds from the sale and will bear all
expenses and fees of registration of the shares.
Our common stock is traded on the Nasdaq National Market under the symbol
"ORPH." The closing sale price of the common stock reported by the Nasdaq
National Market on April 7, 2000 was $9.125 per share.
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SEE THE SECTION TITLED "RISK FACTORS" BEGINNING ON PAGE 3 TO READ ABOUT CERTAIN
FACTORS YOU SHOULD CONSIDER BEFORE BUYING SHARES OF COMMON STOCK.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR ACCURATE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
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ORPHAN MEDICAL, INC.
13911 Ridgedale Drive, Suite 250
Minnetonka, Minnesota 55305
(612) 513-6900
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The date of this prospectus is April 10, 2000
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the
Securities and Exchange Commission (the "SEC"). The prospectus relates to
1,365,000 shares of our common stock which the selling shareholders named in
this prospectus may sell from time to time. We will not receive any of the
proceeds from these sales. We have agreed to pay the expenses incurred in
registering these shares, including legal and accounting fees.
These shares have not been registered under the securities laws of any state or
other jurisdiction as of the date of this prospectus. The selling shareholders
should not make an offer of these shares in any state where the offer is not
permitted. Brokers or dealers should confirm the existence of an exemption from
registration or effect a registration in connection with any offer and sale of
these shares.
You should read this prospectus together with the additional information
described under the heading "Where You Can Find More Information."
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TABLE OF CONTENTS
Page
Risk Factors.............................................................. 3
About Orphan Medical, Inc................................................. 15
Where You Can Find More Information....................................... 15
Selling Shareholders...................................................... 16
Plan of Distribution...................................................... 17
Legal Matters............................................................. 18
Experts................................................................... 18
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RISK FACTORS
AN INVESTMENT IN OUR COMMON STOCK INVOLVES A NUMBER OF RISKS, INCLUDING
AMONG OTHERS, RISKS ASSOCIATED WITH COMPANIES THAT OPERATE IN THE PHARMACEUTICAL
INDUSTRY. THESE RISKS ARE SUBSTANTIAL AND INHERENT IN OUR OPERATIONS AND
INDUSTRY. YOU SHOULD CAREFULLY CONSIDER THE FOLLOWING INFORMATION ABOUT THESE
RISKS, TOGETHER WITH THE INFORMATION IN THE REST OF THIS PROSPECTUS, BEFORE
BUYING SHARES OF COMMON STOCK.
WE HAVE A HISTORY OF LOSSES, WHICH WE EXPECT TO CONTINUE.
We have been unprofitable since our inception in January 1993. We
expect operating losses in 2000 because anticipated gross profits from product
revenues will not offset our operating expenses and additional spending to
continue drug development activities. The amount of these losses may vary
significantly from year-to-year and quarter-to-quarter. Our actual losses will
depend on, among other factors, the timing of product development, regulatory
approval, and market demand for our Food and Drug Administration ("FDA")
approved products. We cannot assure you that we will ever generate sufficient
product revenues to achieve profitability.
LIMITATIONS TO SOURCES OF ADDITIONAL CAPITAL - RESTRICTIONS, COVENANTS AND
RIGHTS RELATED TO SENIOR CONVERTIBLE PREFERRED STOCK AND SERIES B CONVERTIBLE
PREFERRED STOCK.
On July 23, 1998, we completed the private sale to UBS Capital of $7.5
million of Senior Convertible Preferred Stock. On August 2, 1999, we completed
another private sale to UBS Capital of $2.95 million of Series B Convertible
Preferred Stock. In conjunction with the issuance of the preferred shares, we
agreed to several restrictions and covenants, and granted certain voting and
other rights to the holders of the preferred shares. One of the most important
of these restrictions is that we cannot incur additional indebtedness, except
for indebtedness secured solely by our trade receivables, until we have
profitable operations, subject to certain limitations. Another important
restriction is that, without the approval of a majority of the preferred
stockholders, we cannot issue additional equity securities unless the selling
price per share exceeds the then conversion price of the outstanding convertible
preferred stock or the sale of equity is accomplished in a public offering. The
present conversion price is $8.14 per share for the Senior Convertible Preferred
Stock and $6.50 for the Series B Convertible Preferred Stock. These restrictions
could make it more difficult and more costly for us to obtain additional
capital. We cannot assure you that additional sources of capital will be
available to us or, if available, on terms acceptable to us.
POSSIBLE VOLATILITY OF STOCK PRICE.
There is generally significant volatility in the market prices of
securities of early stage companies, and particularly of early stage
pharmaceutical companies. Contributing to this volatility are various factors
and events that can affect our stock price in a positive or negative manner.
These factors and events include, but are not limited to:
o announcements by us or our competitors of new product
developments or clinical testing results;
o governmental approvals, refusals to approval, regulations or
actions;
o developments or disputes relating to patents or proprietary
rights;
o public concern over the safety of therapies;
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o financial performance;
o fluctuations in financial performance from period to period;
and
o small float or number of shares of our stock available for
sale and trade.
These and other factors and events may have a significant impact on our
business and on the market price of the common stock.
WE CANNOT BE SURE THAT FUTURE CAPITAL WILL BE AVAILABLE TO MEET OUR EXPECTED
CAPITAL REQUIREMENTS.
We expect spending for research and development, and sales and
marketing to increase significantly in fiscal 2000. Although we believe that we
have sufficient capital to meet out current business objectives, if we expand
our business plans, we may need additional capital. Adequate funds for our
operations, continued development, and expansion of our business plans, whether
from financial markets or from other sources, may not be available when needed
on acceptable terms, or at all. If we issue additional securities your holding
may be diluted.
POSSIBLE VOLATILITY OF STOCK PRICE AND REDUCED LIQUIDITY OF THE MARKET FOR THE
STOCK - POSSIBLE LOSS OF NASDAQ NATIONAL MARKET LISTING AND FAILURE TO QUALIFY
FOR NASDAQ SMALL CAP MARKET LISTING.
There is a risk that the market value and the liquidity of the public
float for our common stock could be adversely affected in the event we no longer
meet the Nasdaq's requirements for continued listing on the National Market. For
continued listing on the Nasdaq National Market, a company must satisfy a number
of requirements, which in our case includes either: (1) net tangible assets in
excess of $4.0 million as reported on Form 10-Q or Form 10-K or (2) a market
capitalization of at least $50.0 million. At December 31, 1999, our net tangible
assets equaled $3.6 million and our market capitalization was approximately
$34.3 million (based on the last sale price of $5.1875 and 6,606,207 shares
outstanding as of December 31, 1999). Net tangible assets are defined as total
assets less the sum of total liabilities and intangible assets. Market
capitalization is defined as total outstanding shares multiplied by the last
sales price quoted by Nasdaq.
Since December 31, 1999, two events have occurred to improve this
situation. In February, 2000, we completed the sale of an aggregate of 1,365,000
shares of newly issued common stock for net proceeds of $10.7 million. Because
of this financing, we exceeded the Nasdaq net tangible asset requirement as of
March 1, 2000 with performa net tangible assets of $14.3 million. Moreover, as
of March 1, 2000 we had 8,192,249 shares of common stock outstanding and the
last sale price of our stock on March 1, 2000 was $14.25 resulting in a market
capitalization of $116.7 million. Therefore, we currently meet the Nasdaq
National Market listing. However, we cannot assure you that this threshold will
continue to be met or that we will continue to have adequate capital to meet the
net tangible asset requirement.
THERE IS A LIMITED MARKET FOR OUR PRODUCTS.
Most orphan drugs have a potential United States market of less than
$25 million annually and many address annual markets of less than $1 million. We
cannot assure you that sales of our products will be adequate to make us
profitable even if the products are accepted by medical specialists and used by
patients.
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WE RELY ON THE LIMITED PROTECTION OF THE ORPHAN DRUG ACT.
United States
Under the Orphan Drug Act, the FDA may grant orphan drug designation to
drugs intended to treat a "rare disease or condition." The Orphan Drug Act
generally defines "rare disease or condition" as one that affects populations of
fewer than 200,000 people in the United States. The Orphan Drug Act provides us
with certain limited protections for our products.
The first step in obtaining the limited protection under the Orphan
Drug Act is acquiring the FDA's approval of "orphan drug designation," which
must be requested before submitting a New Drug Application ("NDA"). After the
FDA grants orphan drug designation, it publishes the generic identity of the
therapeutic agent and the potential orphan use specified in the request. Orphan
drug designation does not constitute FDA approval. In addition, orphan drug
designation does not convey any advantage in, or shorten the duration of, the
regulatory approval process.
The second step in obtaining the limited protection under the Orphan
Drug Act is acquiring the FDA's recognition of "orphan drug status." The Orphan
Drug Act confers orphan drug status upon the first company to receive FDA
approval to market a drug with "orphan drug designation" for a specific
designated indication. Orphan drug status does not protect against another
formulation or drug of materially different composition from being approved,
with or without orphan drug status, for the same indication. FDA approval also
results in United States marketing exclusivity for a period of seven years,
subject to certain limitations. Although obtaining FDA approval to market a
product with orphan drug status can be advantageous, we cannot assure you that
the scope of protection or the level of marketing exclusivity will remain in
effect in the future. In addition, United States orphan drug status does not
provide any marketing exclusivity in foreign markets. Although certain foreign
countries provide development and marketing benefits to orphan drugs, we cannot
assure you that such benefits can be obtained or, if obtained, will be of
material value to us. The FDA has granted us orphan drug status for Antizol,
Elliotts B Solution, Cystadane, Sucraid, and Busulfex.
We have obtained orphan drug designation for Xyrem and plan to submit
an NDA for approval. Sodium oxybate is the generic identity of the therapeutic
agent for Xyrem. Despite orphan drug designation for Xyrem, another
pharmaceutical company could attempt to develop sodium oxybate for the same
designated indication as Xyrem or may seek approval of an NDA for their drug
prior to the approval of an NDA for Xyrem. If the FDA first approves another
sponsor's NDA for sodium oxybate and for the same indication as Xyrem, that
sponsor will be entitled to exclusive marketing rights. In that case, the FDA
would not approve our application to market Xyrem for seven years, if at all. We
are aware that the FDA has granted Teva (formerly Biocraft) orphan drug
designation for the use of sodium oxybate to treat the symptoms of narcolepsy,
however, we have obtained the exclusive right to use Teva's data for one
controlled study in our NDA submission. We cannot assure you that the FDA will
approve Xyrem first for the designated indication. We also cannot assure you
that the FDA will not grant orphan drug designation and marketing approval to
other competing products prior to approving our NDA for Xyrem.
Even if the FDA approves an NDA for a drug with an orphan drug
designation, the FDA may still approve the same drug for a different indication,
or a molecular variation of the same drug for the same indication. We are aware
that the FDA granted to Sparta Pharmaceutical, which has been acquired by
SuperGen Inc., orphan drug
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designation for an intravenous busulfan for a closely related indication. If the
FDA approves an NDA for Sparta's drug, Sparta could seek orphan drug status. In
addition, the FDA does not restrict doctors from prescribing an approved drug
for uses not approved by the FDA for that drug. Thus, a doctor could prescribe
another company's drug for indications for which our product has received FDA
approval and orphan drug status. Significant "off label" use, that is,
prescribing approved drugs for unapproved uses, could adversely affect the
marketing potential of any of our products that have received orphan drug status
and NDA approval.
The possible amendment of the Orphan Drug Act by Congress has been the
subject of congressional discussion from time to time over the last ten years.
Although Congress has made no significant changes to the Orphan Drug Act for a
number of years, members of Congress have from time to time proposed legislation
that would limit the application of the Orphan Drug Act. We cannot assure you
that the Orphan Drug Act will remain in effect or that it will remain in effect
in its current form. The precise scope of protection that orphan drug
designation and marketing approval may afford in the future is unknown. We
cannot assure you that the current level of exclusivity will remain in effect.
Europe
An orphan drug act was recently passed in Europe that provides for up
to ten years of market exclusivity for the first company to obtain regulatory
approval for an orphan indication or a designated drug. This law, however, has
yet to be put into effect. For a pharmaceutical product to qualify, the
prevalence (or incidence), whichever is greater, must not exceed five patients
per 10,000 population. We cannot provide assurance that this law will be enacted
or that any of our pharmaceutical products will qualify for orphan drug
protection in Europe or that another company will not obtain an approval which
would block us from marketing our product in Europe.
THE FDA AND FOREIGN REGULATORY AUTHORITIES MUST APPROVE OUR PRODUCTS FOR SALE.
Government regulation in the United States and abroad is a significant
factor in the testing, production and marketing of our current and future
products. Each product must undergo an extensive regulatory review process
conducted by the United States Food and Drug Administration and by comparable
agencies in other countries. We cannot market any medicine we may develop or
license as a prescription product in any jurisdiction, including foreign
countries, in which the product does not receive regulatory approval. The
approval process can take many years and requires the expenditure of substantial
resources.
We depend on external laboratories and medical institutions to conduct
our pre-clinical and clinical analytical testing in compliance with clinical and
laboratory practices established by the FDA. The data obtained from pre-clinical
and clinical testing is subject to varying interpretations that could delay,
limit or prevent regulatory approval. In addition, changes in FDA policy for
drug approval during the period of development and in the requirements for
regulatory review of each submitted NDA could result in additional delays or
outright rejection.
We cannot assure you that the FDA or any foreign regulatory authority
will approve in a timely manner, if at all, any product we develop. Generally,
the FDA and foreign regulatory authorities approve only a very small percentage
of newly discovered pharmaceutical compounds that enter pre-clinical
development. Moreover, even if the FDA approves a product, it may place
commercially unacceptable limitations on the uses, or "indications," for
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which a product may be marketed. This would result in additional cost and delay
for further studies to provide additional data on safety or effectiveness.
FDA APPROVAL DOES NOT GUARANTEE FINANCIAL SUCCESS.
Six of our products have been approved for marketing by regulatory
authorities in the United States or elsewhere. Even if we obtain FDA approval to
market Xyrem, we cannot assure you that Xyrem or our other products will be
commercially successful or achieve the expected financial results. We may
encounter unanticipated problems relating to the development, manufacturing,
distribution and marketing of our products. Some of these problems may be beyond
our financial and technical capacity to solve. The failure to adequately address
any such problems could have a material adverse effect on our business and our
prospects. In addition, the efforts of government entities and third party
payors to contain or reduce the costs of health care may adversely affect our
sales and limit the commercial success of our products.
We cannot completely insulate our drug development portfolio from the
possibility of clinical or commercial failures. Some products that we have
selected for development may not produce the results expected during clinical
trials or receive FDA approval. Drugs approved by the FDA may not generate
product sales of an acceptable level. We have discontinued the development of
eleven products from our portfolio since inception: L-Cycloserine in 1994;
Glucaric Acid in 1996; and nine other products in 1997. We discontinued the nine
products in 1997 in order to focus our development efforts and resources on
those products that fit within three selected strategic therapeutic market
segments: Antidote; Oncology Support; and Sleep Disorders. In December 1998, we
sold our rights to colloidal bismuth subcitrate for $750,000. We are evaluating
the potential value of our rights in other discontinued products. We cannot
assure you that any of these discontinued products have any value. Depending on
available financing, we may continue to develop one or more of the discontinued
products. We cannot assure you that we will continue development on all other
proposed products or that we will continue marketing all FDA approved products.
SIGNIFICANT GOVERNMENT REGULATION CONTINUES ONCE A PRODUCT IS APPROVED FOR SALE.
After the FDA's Division of Drug Marketing approves a drug, the FDA's
Advertising and Communication must approve such drug's marketing claims, which
are the basis for the drug's labeling, advertising and promotion. We cannot be
sure that the Division of Drug Marketing, Advertising and Communication will
approve our proposed marketing claims. The failure of the Division of Drug
Marketing, Advertising and Communication to approve our proposed marketing
claims could have a material adverse effect on our business and prospects.
The FDA requires that a company conduct "post-marketing adverse event
surveillance programs" to monitor any side effects that occur after the
company's drug is approved for marketing. If the surveillance program indicates
unsafe side effects, the FDA may recall the product, and suspend or terminate a
company's authorization to market the product. The FDA also regulates the
manufacturing process for an approved drug. The FDA may impose restrictions or
sanctions upon the subsequent discovery of previously unknown problems with a
product or manufacturer. One possible sanction is requiring the withdrawal of
such product from the market. The FDA must approve any change in manufacturer as
well as most changes in the manufacturing process prior to implementation.
Obtaining the FDA's approval for a change in manufacturing procedures or change
in manufacturers is a lengthy process and could cause production delays and loss
of sales, which would have a material adverse effect on our business and our
prospects.
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Certain foreign countries regulate the sales price of a product after
marketing approval is granted. We cannot be sure that we can sell our products
at satisfactory prices in foreign markets even if foreign regulatory authorities
grant marketing approval.
WE RELY ON OTHERS FOR PRODUCT DEVELOPMENT OPPORTUNITIES.
We engage only in limited research to identify new pharmaceutical
compounds. To build our product portfolio, we have adopted a license and
acquisition strategy. This strategy for growth requires us to identify and
acquire pharmaceutical products targeted at niche markets within selected
strategic therapeutic market segments. These products usually require further
development and approval by regulatory bodies before they can be marketed. We
cannot assure you that any such products can be successfully developed, approved
or marketed. We must rely upon the willingness of others to sell or license
pharmaceutical product opportunities to us. Other companies, including those
with substantially greater resources, compete with us to acquire such products.
We cannot assure you that we will be able to acquire rights to additional
products on acceptable terms, if at all. Our failure to acquire or license any
new pharmaceutical products or products that fit within one of our strategic
therapeutic market segment, or our failure to promote and market any products
successfully or products within an existing strategic therapeutic market
segment, could have a material adverse effect on our business and our prospects.
We have contractual development rights to certain compounds through
various license agreements. Generally, the licensor can unilaterally terminate
these agreements for several reasons, including, but not limited to the
following reasons:
o for cause if we breach the contract;
o if we become insolvent or bankrupt;
o if we do not apply specified minimum resources and efforts to
develop the compound under license; or
o if we do not achieve certain minimum royalty payments, or in
some cases, minimum sales levels.
We cannot assure you that we can meet all specified requirements and avoid
termination of any license agreements. We cannot assure you that if any
agreement is terminated, we will be able to enter into similar agreements on
terms as favorable as those contained in our existing license agreements.
WE DEPEND ON OTHERS TO MANUFACTURE AND SUPPLY THE PRODUCTS WE MARKET.
We do not have and do not intend to establish any internal product
testing, synthesis of bulk drug substance, or manufacturing capability for drug
product. Accordingly, we depend on others to supply and manufacture the
components incorporated into all of our finished drug products. The inability to
contract for these purposes on acceptable terms could adversely affect our
ability to develop and market our products. Failure by parties with whom we
contract to adequately perform their responsibilities may delay the submission
of products for regulatory approval, impair our ability to deliver our products
on a timely basis or otherwise adversely affect our business and our prospects.
The loss of a supply or manufacturing contractor could materially adversely
affect our business and our prospects.
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The loss of either a bulk drug supplier or drug product manufacturer
would require us to obtain regulatory clearance in the form of a "pre-approval
submission" and incur validation and other costs associated with the transfer of
the bulk drug or drug product manufacturing process. We believe that it could
take as long as one year for the FDA to approve such a submission. Because our
products are targeted to relatively small markets and our manufacturing
production runs are small by industry standards, we have not incurred the added
costs to certify and maintain secondary sources of supply for bulk drug
substance or backup drug product manufacturers for some products. Should we lose
either a bulk drug supplier or a drug product manufacturer, we could run out of
salable product to meet market demands or investigational product for use in
clinical trials, while we wait for the FDA approval of a new bulk drug supplier
or drug product manufacturer. We cannot assure you that the change of a bulk
drug supplier or drug product manufacturer and the transfer of the processes to
another third party will be approved by the FDA, and if approved, in a timely
manner. The loss of or the change of a bulk drug supplier or a drug product
manufacturer could have a material adverse effect on our business and prospects.
BULK DRUG SUPPLY
Bulk drug substance is the active chemical compound used in the
manufacture of our drug products. We depend substantially on Ash Stevens, Inc.
for the supply of bulk drug substance used in Busulfex, Antizol, and
Antizol-Vet. If we were to lose Ash Stevens as a supplier, we would be required
to identify a new supplier for the bulk drug substance used in products that
provided approximately 90% of 1999 and all of 1998 revenues and are expected to
generate over 90% of 2000 total revenues. We depend substantially on Lonza, Inc.
for the supply of bulk drug substance used in Xyrem. If we were to lose Lonza as
a supplier, we would be required to identify a new supplier before an NDA is
submitted for Xyrem. We also cannot assure you that our bulk drug supply
arrangements with Ash Stevens and Lonza, or any other future such supplier,
might not change in the future. We cannot assure you that any change would not
adversely affect production of Busulfex, Antizol, Antizol-Vet, Xyrem, or any
other drug the Company might attempt to develop or market.
DRUG PRODUCT MANUFACTURE
From bulk drug substance, drug product manufacturers formulate a
finished drug product and package the product for sale or for use in clinical
trials. We depend substantially on an affiliate of Boehringer Ingelheim for drug
product manufacturing of Busulfex, Antizol, and Antizol-Vet. If we were to lose
Boehringer as a manufacturer, we would be required to identify a new
manufacturer for drug products that provided approximately 90% of 1999 and all
of 1998 revenues and are expected to generate over 90% of 2000 total revenues.
We have identified Catalytica Pharmaceuticals, Inc. and Global Pharm, Inc. as
drug product manufacturers for Xyrem and expect to contract with either or both
of these companies for its manufacture. Currently, however, we do not have a
contract with either firm. If we do not contract with either of these firms, we
would be required to identify a new drug product manufacturer before an NDA is
submitted for Xyrem. We cannot assure you that our drug product manufacturing
arrangements with Boehringer and Global Pharm might not change in the future. We
are currently negotiating with an additional manufacturer for additional
production of Xyrem. We do not have a contract in place with this supplier at
this time and cannot assure you that contract negotiations will be completed and
a contract executed. We cannot assure you that any change would not adversely
affect production of Busulfex, Antizol, Antizol-Vet, or Xyrem, or any other drug
that we might attempt to develop or market.
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WE CANNOT CONTROL OUR CONTRACTORS' COMPLIANCE WITH APPLICABLE REGULATIONS.
The FDA defines and regulates good manufacturing practices to which
bulk drug suppliers and drug product manufacturers are subject. The Drug
Enforcement Agency (DEA) defines and regulates the handling and reporting
requirements for certain drugs which have abuse potential, known as "scheduled
drugs". Foreign regulatory authorities prescribe similar rules and regulations.
Our supply and manufacturing contractors must comply with these regulatory
prescriptions. Failure by our contractors to comply with FDA or DEA requirements
or applicable foreign requirements could result in significant time delays in
our inability to commercialize or continue to market a product. Either result
could have a material adverse effect on our business and prospects. Failure to
comply with good marketing practices or other applicable legal requirements can
lead to federal seizure of violative products, injunctive actions brought by the
federal government, or potential criminal and civil liability for Orphan, our
officers, or our employees. We cannot assure you that we will be able to
maintain relationships either domestically or abroad with contractors whose
facilities and procedures comply or will continue to comply with FDA or DEA
requirements or applicable foreign requirements.
WE DEPEND UPON OTHERS FOR DISTRIBUTION.
We have an exclusive agreement with Cardinal Health, Inc. to provide a
variety of services to support the effective distribution of our products.
Cardinal will provide integrated distribution and operations services to process
and support transactions between us and our wholesalers, specialty distributors,
and direct customers. Cardinal also will provide reimbursement management,
patient assistance and information hotline services, and specialty distribution
and marketing services to physician practices. Cardinal currently distributes
Busulfex, Cystadane, Elliotts B Solution, Antizol, Antizol-Vet, and Sucraid.
Cardinal also will distribute our proposed products should those products
receive marketing clearance from the FDA. We will substantially depend upon
Cardinal's ability to successfully distribute Busulfex, Elliotts B Solution,
Antizol, Antizol-Vet, and Sucraid and potentially any other of our products that
may receive marketing clearance from the FDA in the future.
Chronimed Inc. is the principal distributor, on a non-exclusive basis,
in the United States for Cystadane. Chronimed distributes this product directly
to patients through its mail order pharmacy. We substantially depend upon
Chronimed's ability to successfully distribute Cystadane directly to patients in
the United States.
We cannot assure you that other distribution companies would be
available or continue to be available on commercially acceptable terms. The loss
of a distributor or failure to renew agreements with an existing distributor
would have a material adverse effect on our business and prospects.
WE RELY ON FOREIGN MARKETING ALLIANCES AND HAVE NO ASSURANCE OF FOREIGN
LICENSEES.
Our strategy to address foreign markets is to license foreign marketing
and distribution rights after a new drug application (referred to in the
industry as an "NDA") is submitted or approved in the United States. We consider
Europe, Japan, and Canada our most attractive foreign markets. Our current
foreign developments are:
o EUROPE. We have licensed the marketing and distribution rights
for Busulfex, Antizol, Cystadane and Sucraid in Europe. If our
licensees are unsuccessful in their distribution efforts, we
may find it difficult to contract with other distributors for
these products within Europe. Distribution of
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Busulfex is limited to "named patient" or "emergency use"
basis until full regulatory approval is obtained. This
"emergency use" distribution of Busulfex is not expected to
result in much, if any, contribution to the Company's
revenues.
o AUSTRALIA AND NEW ZEALAND. We have licensed marketing and
distribution rights for Cystadane and Sucraid in Australia and
New Zealand, but sales of these products have not been
material. We do not expect sales to increase in the near
future to the point that they become material.
o ISRAEL. We have licensed marketing and distribution rights for
Busulfex, Cystadane, Elliotts B Solution and Sucraid in
Israel. Full regulatory approval was obtained in Israel in
February 2000. We do not expect such distribution to result in
material revenues.
o CANADA. We have licensed marketing and distribution rights for
Antizol and Cystadane in Canada. We do not expect such
distribution to result in material revenues.
o CENTRAL AMERICA. We have licensed marketing and distribution
rights for Elliotts B Solution in Central America, but sales
have not been material. We do not expect domestic or foreign
sales of Elliotts B Solution to become material.
We depend on our foreign licensees for the regulatory registration of our
products in foreign countries. We cannot be sure that our licensees can obtain
such registration. In addition, we cannot be sure that we will be able to
negotiate commercially acceptable license agreements for our other products or
in additional foreign countries. Furthermore, we cannot assure you that these
companies will be successful in marketing and selling our products in their
respective territories.
OUR PRODUCTS MIGHT BE RECALLED.
A product can be recalled at our discretion or at the discretion of the
FDA, the U.S. Federal Trade Commission, or other government agencies having
regulatory authority for marketed products. A recall may occur due to disputed
labeling claims, manufacturing issues, quality defects, or other reasons. We
cannot assure you that a product recall will not occur. We do not carry any
insurance to cover the risk of a potential product recall. Any product recall
could have a material adverse effect on our business and prospects. To date, no
recall of products marketed by the Company has occurred.
WE FACE LIMITS ON PRICE FLEXIBILITY AND THIRD-PARTY REIMBURSEMENT.
The flexibility of prices that we can charge for our products depends
on government regulation, both in the United States and abroad, and on other
third parties. One important factor is the extent to which reimbursement for our
products will be available to patients from government health administration
authorities, private health insurers and other third-party payors. Government
officials and private health insurers are increasingly challenging the price of
medical products and services. We are uncertain as to the pricing flexibility we
will have with respect to, and if we will be reimbursed for, newly approved
health care products.
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In the United States, we expect continuing federal and state proposals
to implement government control of the pricing and profitability of prescription
pharmaceuticals. Cost controls, if mandated by a government agency, could
decrease, or limit, the price we receive for our products or products we may
develop in the future. We may not be able to recover our development costs,
which could be substantial. We may not be able to realize an appropriate profit
margin. This could have a material adverse effect on our business. Furthermore,
federal and state regulations govern or influence reimbursement of health care
providers for medical treatment of certain patients. We cannot assure you that
actions taken by federal and/or state governments, if any, with regard to health
care reform will not have a material adverse effect on our business and
prospects.
Certain private health insurers and third-party payors may attempt to
control costs further by selecting exclusive providers of pharmaceuticals. If
such arrangements are made with our competitors, these insurers and third-party
payors would not reimburse patients who purchase our competing products. This
would diminish the market for our products and could have a material adverse
effect on our business and prospects.
PATENTS AND OTHER PROPRIETARY RIGHTS ARE SIGNIFICANT FACTORS IN THE
PHARMACEUTICAL INDUSTRY.
The pharmaceutical industry and the investment community places
considerable importance and value on obtaining patent and trade secret
protection for new technologies, products and processes. The patent position of
pharmaceutical firms is often highly uncertain and generally involves complex
legal, technical and factual questions. Our success depends on several issues,
including, but not limited to our ability:
o to obtain, and enforce proprietary protection for our products
under United States and foreign patent laws and other
intellectual property laws;
o to preserve the confidentiality of our trade secrets; and
o to operate without infringing the proprietary rights of third
parties.
We evaluate the desirability of seeking patent or other forms of
protection for our products in foreign markets based on the expected costs and
relative benefits of attaining such protection. We cannot assure you that any
patents will be issued from any applications or that any issued patents will
afford us adequate protection or competitive advantage. Also, we cannot assure
you that any issued patents will not be challenged, invalidated, infringed or
circumvented. Parties not affiliated with us have obtained or may obtain United
States or foreign patents or possess or may possess proprietary rights relating
to our products. We cannot assure you that patents now in existence or later
issued to others will not adversely affect the development or commercialization
of our products.
We believe that the active ingredients or compounds in our FDA approved
and proposed products, Cystadane, Elliotts B Solution, Antizol, Antizol-Vet,
Xyrem and Sucraid, are in the public domain and presently are not subject to
patent protection in the United States. However, we have filed a patent
application with respect to our formulation of Xyrem oral solution. United
States patents issued to the licensor covers our formulation and use of
Busulfex. We could, however, incur substantial costs asserting any infringement
claims that we may have against others.
We seek to protect our proprietary information and technology, in part,
through confidentiality agreements and inventors' rights agreements with our
employees. We cannot assure you that these agreements will not be breached, that
we will have adequate remedies for any breach, or that our trade secrets will
not otherwise be
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disclosed to or discovered by our competitors. We also cannot assure you that
our planned activities will not infringe patents owned by others. We could incur
substantial costs in defending infringement suits brought against us. We also
could incur substantial costs in connection with any suits relating to matters
for which we have agreed to indemnify our licensors or distributors. An adverse
outcome in any such litigation could have a material adverse effect on our
business and prospects. In addition, we often must obtain licenses under patents
or other proprietary rights of third parties. We cannot assure you that we can
obtain any such licenses on acceptable terms, if at all. If we cannot obtain
required licenses on acceptable terms, we could encounter substantial
difficulties in developing, manufacturing or marketing one or more of our
products.
WE FACE INTENSE COMPETITION IN OUR INDUSTRY.
Competition in the pharmaceutical industry is intense. Potential
competitors in the United States are numerous and include pharmaceutical,
chemical and biotechnology companies. Many of these companies have substantially
greater capital resources, marketing experience, research and development staffs
and facilities than we do. We seek to limit potential sources of competition by
developing products that are eligible for orphan drug designation and NDA
approval or other forms of protection. We cannot assure you, however, that our
competitors will not succeed in developing similar technologies and products
more rapidly than we can. Similarly, we cannot assure you that these competing
technologies and products will not be more effective than any of those that we
have developed or are currently developing.
WE EXPECT RAPID TECHNOLOGICAL AND OTHER CHANGE TO BE CONSTANT IN OUR INDUSTRY.
The pharmaceutical industry has experienced rapid and significant
technological change as well as structural changes, such as those brought about
by changes in heath care delivery or in product distribution. We expect that
pharmaceutical technology will continue to develop and change rapidly, and our
future success will depend, in large part, on our ability to develop and
maintain a competitive position. Technological development by others may result
in our products becoming obsolete before they are marketed or before we recover
a significant portion of the development and commercialization expenses incurred
with respect to such products. In addition, alternative therapies, new medical
treatments, or changes in the manner in which health care is delivered or
products provided could alter existing treatment regimes or health care
practices, and thereby reduce the need for one or more of our products, which
would adversely affect our business and our prospects.
WE FACE SUBSTANTIAL PRODUCT LIABILITY AND INSURANCE RISKS.
Testing and selling health care products entails the inherent risk of
product liability claims. The cost of product liability insurance coverage has
increased and is likely to continue to increase in the future. Substantial
increases in insurance premium costs in many cases have rendered coverage
economically impractical. We currently carry product liability coverage in the
aggregate amount of $10 million for all claims made in any policy year. Although
to date we have not been the subject of any product liability or other claims,
we cannot assure you that we will be able to maintain product liability
insurance on acceptable terms or that our insurance will provide adequate
coverage against potential claims. A successful uninsured product liability or
other claim against us could have a material adverse effect on our business and
prospects.
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<PAGE>
IMPACT OF YEAR 2000 READINESS ISSUE.
We have assessed and continue to assess the impact of the so-called
"Year 2000 Readiness Issue" on our reporting systems and operations. The Year
2000 Readiness Issue relates to the ability of computer hardware, software, and
firmware products to accurately process date/time data (including calculating,
comparing, and sequencing) from, into, and between the twentieth and
twenty-first centuries, and the years 1999 and 2000 and leap year calculations.
The Year 2000 Readiness Issue also relates to the ability to properly exchange
time/date data between such products. Systems that are not year 2000 compliant
might recognize the year 2000 as the year 1900, or not recognize a year at all.
This inability to recognize or properly treat the year 2000 may cause our
systems, or the systems used by our suppliers, distributors, customers or
regulatory agencies such as the FDA, to process critical financial and
operational information incorrectly, or not at all.
Our information technology systems consist of computer hardware systems
and software applications supplied by third parties. Our strategy has been to
replace our information technology systems with current technology, which is
both "year 2000 compliant" and more efficient. We have also purchased and
implemented financial and operational software upgrades that are year 2000
compliant. For the twelve months ended December 31, 1999, our information
technology system purchases have not been material. Our information technology
systems are year 2000 compliant.
Our assessment of internal systems includes a review of non-information
technology systems. This assessment includes a review of our internal equipment
and facilities. Based upon this review, we believe that our processes and
equipment are year 2000 compliant.
We have identified third parties, with which we have material
relationships, including suppliers, distributors and other key vendors of
materials and services. These parties or organizations have confirmed that they
have implemented Year 2000 Readiness Programs. We have not developed a
contingency plan to provide for continuity of business operations in the event
material third parties experience a disruption of service due to the Year 2000
Readiness Issue. Potential problems include, but are not limited to, loss of
electricity, loss of communications (data and voice), and loss of transportation
services. However, even if all material third parties confirm that they are or
expect to be year 2000 compliant, we cannot state with certainty that such
parties will be compliant or that their systems will not fail in the future.
Failure of third party systems on which we rely could significantly disrupt our
ability to transact business with our customers and suppliers. It is impossible
to assess fully the potential consequences in the event service interruptions
from suppliers occur or in the event that there are disruptions in such
infrastructure areas as utilities, communications, transportation, banking and
government.
As of March 1, 2000, the Company is not aware of a failure of its or
any of its vendor's technology systems related to the year 2000 issue. The
Company will continue to monitor the year 2000 issue.
-------------------
THIS PROSPECTUS CONTAINS FORWARD-LOOKING STATEMENTS BASED ON OUR
CURRENT EXPECTATIONS, ASSUMPTIONS, ESTIMATES AND PROJECTIONS ABOUT OUR BUSINESS
AND OUR INDUSTRY. THESE FORWARD-LOOKING STATEMENTS INVOLVE RISKS AND
UNCERTAINTIES. THESE STATEMENT MAY BE IDENTIFIED BY THE USE OF WORDS SUCH AS
"EXPECTS," "ANTICIPATES," "INTENDS," "PLANS" AND SIMILAR EXPRESSIONS. OUR ACTUAL
RESULTS COULD DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THESE FORWARD-LOOKING
STATEMENTS AS A RESULT OF A NUMBER OF FACTORS, AS MORE FULLY DESCRIBED ABOVE AND
ELSEWHERE IN THIS PROSPECTUS. WE UNDERTAKE NO OBLIGATION TO UPDATE PUBLICLY ANY
FORWARD-LOOKING STATEMENTS FOR ANY REASON, EVEN IF NEW INFORMATION BECOMES
AVAILABLE OR OTHER EVENTS OCCUR IN THE FUTURE.
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ABOUT ORPHAN MEDICAL, INC.
Orphan Medical, Inc. was incorporated on June 17, 1994 in order to
carry on the business previously conducted by the Orphan Medical Division of
Chronimed, Inc. We acquire, develop, and market products of high medical value
intended to address inadequately treated or uncommon diseases within selected
strategic therapeutic market segments. A drug has high medical value if it
offers a major improvement in the safety or efficacy of patient treatment and
has no substantial equivalent substitute. Our activities have consisted
primarily of obtaining the rights for pharmaceutical products, hiring the
personnel required to implement our business plan, managing the development of
these products, preparing for the commercial introduction of six products and
fund raising. At December 31, 1999, six of our products, Busulfex, Elliotts B
Solution, Cystadane, Antizol-Vet, Antizol and Sucraid have been approved by the
FDA for marketing and are commercially available. One product, Xyrem, was, and
continues to be, in active development. We expect to seek additional products
for development. We have not generated sufficient levels of revenue from our
approved products to date to fund our operating activities and have sustained
significant operating losses each year since inception. In addition, we expect
operating losses to continue through at least 2000. In the first quarter of
1999, we no longer considered our company to be in the development stage.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file at
the SEC's public reference rooms in Washington, D.C., New York, N.Y. and
Chicago, Illinois. Please call the SEC at 1-800-SEC-0330 for further information
on the public reference rooms. Our SEC filings are also available to the public
from the SEC's web site at http://www.sec.gov. Reports, proxy and information
statements and other information concerning us can also be inspected at the
offices of the National Association of Securities Dealers, 1735 K. Street N.W.,
Washington, D.C. 20006.
The SEC allows us to "incorporate by reference" the information that we
file with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
considered to be part of this prospectus, and later information that we file
with the SEC will automatically update this prospectus. We incorporate by
reference the following documents listed below and any future filings made with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act
of 1934, as amended, until the selling shareholders sell all the shares:
o Annual Report on Form 10-K for the year ended December 31,
1998;
o Quarterly Reports on Form 10-Q for the quarters ended December
31, September 30 and June 30, 1999;
o Current Reports on Form 8-K filed on March 10, 2000 and August
10, 1999; and
o the description of the common stock contained in our
Registration Statement on Form S-1, dated March 11, 1996 (File
No. 333-2200), and any amendment or report filed to update
such description filed subsequent to the date of this
prospectus and prior to the termination of the offering of the
shares.
You may request a copy of these filings at no cost, by writing or
telephoning us at the following address:
Orphan Medical, Inc.
13911 Ridgedale Drive, Suite 250
Minnetonka, Minnesota 55305
Attn: Tim McGrath
(612) 513-6900
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<PAGE>
You should rely only on the information incorporated by reference or
provided in this prospectus or any supplement. We have not authorized anyone
else to provide you with different information. The selling shareholders will
not make an offer of the shares in any state where the offer is not permitted.
You should not assume that the information in this prospectus or any supplement
is accurate as of any date other than the date on the front of those documents.
SELLING SHAREHOLDERS
We have agreed to register 1,365,000 shares for resale by the selling
shareholders. This number does not include an indeterminate number of shares
that may be registered and issued in accordance with Rule 416 under the
Securities Act of 1933, as amended, to prevent dilution of the common stock
resulting from stock splits, stock dividends or other events, or changes in the
exercise price of warrants.
The following table lists the selling shareholders and the number of shares they
beneficially own as of March 17, 2000 and the number of shares that they may
sell upon registration. Beneficial ownership is determined in accordance with
the rules of the Security and Exchange Commission
<TABLE>
<CAPTION>
NUMBER OF SHARES OF NUMBER OF SHARES OF
COMMON STOCK MAXIMUM NUMBER OF SHARES COMMON STOCK
BENEFICIALLY OWNED TO BE ISSUED PURSUANT TO BENEFICIALLY OWNED
NAME PRIOR TO THE OFFERING THIS PROSPECTUS AFTER THE OFFERING(1)
<S> <C> <C> <C>
DG LUX LACUNA APO BIOTECH FUND 315,595 100,000 215,595
Caduceus Capital Trust 400,000 400,000 0
Caduceux Capital II L.P. 180,000 180,000 0
Paine Webber Eucalyptus Fund LLC 650,000 650,000 0
Paine Webber Eucalyptus Fund Ltd. 35,000 35,000 0
TOTAL 1,580,595 1,365,000 215,595
</TABLE>
(1) Assumes the sale of all shares offered by this prospectus.
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PLAN OF DISTRIBUTION
We are registering the shares on behalf of the selling shareholders. As
used in this prospectus, the term "selling shareholders" includes donees and
pledgees selling shares received from a named selling shareholder after the date
of this prospectus. The selling shareholders will offer and sell the shares to
which this prospectus relates for their own accounts. We will not receive any
proceeds from the sale of the shares. We will bear all fees and expenses in
connection with the registration of the shares. The selling shareholders shall
bear any fees and expenses of any attorneys or other advisors retained by the
selling shareholders in connection with the registration.
The selling shareholders may offer and sell the shares from time to
time in one or more types of the following transactions at prevailing market
prices or at negotiated prices:
o block transactions
o on the Nasdaq National Market
o directly with market makers or in privately negotiated
transactions
o through put or call option transactions
o through short sales, or
o a combination of these methods of sale.
Sales may be made to or through brokers or dealers who may receive compensation
in the form of discounts, concessions or commissions from the selling
shareholders or the purchasers of the shares. As of the date of this prospectus,
we are not aware of any agreement, arrangement or understanding between any
broker or dealer and the selling shareholders regarding the sale of their
shares. In addition, we are not aware of any underwriter or coordinating broker
acting in connection with the proposed sale of shares by the selling
shareholders. The selling shareholders may also resell all or a portion of these
shares in open market transactions in reliance upon Rule 144 under the
Securities Act, provided they meet the criteria and conform to the requirements
of that Rule. We cannot assure you that the selling shareholders will sell any
or all of the shares that they offer.
The selling shareholders and any brokers or dealers who participate in
the sale of the shares may be deemed to be "underwriters" within the meaning of
the Securities Act of 1933, as amended, and any commissions received by them and
any profits realized by them on the resale of shares may be deemed to be
underwriting discounts or commissions under the Securities Act. Because the
selling shareholders may be deemed to be "underwriters" within the meaning of
the Securities Act, the selling shareholders will be subject to the prospectus
delivery requirements of the Securities Act. We have informed the selling
shareholders that their sales in the market must comply with the requirements of
the rules and regulations of the Exchange Act.
Upon notification to us by a selling shareholder that any material
arrangement has been entered into with a broker or dealer for the sale of shares
through a block trade, special offering, exchange distribution or secondary
distribution or a purchase by a broker or dealer, a supplement to this
prospectus will be filed, if required, pursuant to Rule 424(b) under the
Securities Act, disclosing:
(i) the name of each such selling shareholder and of the
participating brokers or dealers,
(ii) the number of shares involved,
(iii) the price at which such shares were sold,
(iv) the commissions paid or discounts or concessions allowed to
such brokers or dealers, where applicable,
(v) that such brokers or dealers did not conduct any investigation
to verify the information set out or incorporated by reference
in this prospectus, and
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<PAGE>
(vi) other facts material to the transaction.
In addition, upon notification to us by a selling shareholder that a donee or
pledgee intends to sell more than 500 shares, a supplement to this prospectus
will be filed if required.
LEGAL MATTERS
The validity of the shares offered in this prospectus has been passed
upon by Dorsey & Whitney LLP, Minneapolis, Minnesota.
EXPERTS
Ernst and Young LLP, independent auditors, have audited our financial
statements included in our Annual Report on Form 10-K for the year ended
December 31, 1998, as set forth in their report, which is incorporated by
reference in this prospectus and elsewhere in the registration statement. Our
financial statements are incorporated by reference in reliance upon Ernst and
Young LLP's report, given on their authority as experts in accounting and
auditing.
