PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this prospectus.
Because this is only a summary, it does not contain all of the information that
may be important to you. You should read the entire prospectus carefully. You
should consider the information under "Risk Factors" and in the financial
statements and the notes relating to these financial statements, together with
the information included elsewhere in this prospectus, before deciding to invest
in our common stock. In this prospectus, unless the context indicates otherwise,
the terms Xcel, we, our and us refer to Xcel Pharmaceuticals, Inc.
Overview
We are a specialty pharmaceutical company that acquires and markets prescription
products in focused therapeutic markets in the United States. Our initial market
is neurology, which we consider to be a focused market because a limited number
of high-prescribing physicians write a significant number of prescriptions for
neurology products. High-prescribing physicians write a significantly greater
number of prescriptions for the products in a particular market than their
peers. Our products, Diastat and Mysoline, are used in the treatment of seizures
principally associated with epilepsy. Our strategy is to increase sales of our
current products through targeted sales and marketing efforts, to acquire
additional products in neurology that leverage our existing sales organization,
to acquire additional products in other focused markets and to develop product
enhancements.
The neurology market is attractive to us because it is a large and rapidly
growing focused market. Sales of neurology products in the United States totaled
$6.7 billion in 2001, and grew at an average annual rate of 23% from 1997 to
2001. Sales of products used to treat epileptic seizures in the United States
totaled $4.6 billion in 2001, and grew at an average annual rate of 26% from
1997 to 2001. Diastat is the only drug approved in the United States for the
acute treatment of seizures outside of a hospital setting. Despite limited
historical promotion, total retail prescriptions for Diastat, which was launched
in October 1997, grew from 3,100 in the first quarter of 1998 to 20,900 in the
fourth quarter of 2001. Diastat has orphan drug exclusivity, which can be
granted by the Food and Drug Administration to the first drug approved to treat
a condition that affects a limited patient population, through July 2004.
Mysoline has been used since the early 1950s for the chronic treatment of
seizures associated with epilepsy and has maintained stable prescription levels
for many years. All of our revenues come from sales of Diastat and Mysoline.
The concentration of high-prescribing physicians in the neurology market enables
us to promote our products effectively with a small, dedicated sales and
marketing organization and a limited corporate infrastructure. During 2001, the
14,000 neurologists and pediatric neurologists in the United States collectively
wrote prescriptions for 29%, or $1.3 billion, of the products used to treat
epileptic seizures. Our nationwide field sales organization of 80 experienced
professionals promotes our products to 8,000 of the highest-prescribing
physicians in this group. We maintain a limited corporate infrastructure to
support our field sales organization and to identify and acquire additional
products. We rely on third parties to manufacture and distribute our products
and to support our development of product enhancements.
We believe that the changing pharmaceutical industry landscape will present
significant opportunities for us to acquire additional products. Larger
pharmaceutical companies are shifting their sales and marketing efforts away
from smaller products toward products with higher revenue potential and new
product launches. As a result, an increasing number of smaller products that may
have growth potential are receiving little or no promotional effort and present
potentially attractive acquisition opportunities for us. We continually evaluate
opportunities to acquire these types of products, although currently we have no
specific agreements or commitments with respect to any product acquisitions. We
currently are analyzing the results from two post-approval clinical studies for
Diastat and we also are evaluating other potential product enhancements for both
Diastat and Mysoline.
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We were founded in January 2001 and began selling Diastat and Mysoline in April
2001. Our senior management has over 30 years of collective experience acquiring
and marketing branded products in the specialty pharmaceutical industry.
Strategy
Our objective is to capitalize on our management team's experience acquiring and
marketing pharmaceutical products. We intend to become a leading specialty
pharmaceutical company marketing products in focused therapeutic markets in the
United States. Specifically, our strategy is to:
• Expand Sales of Diastat. We believe there are significant
opportunities to expand sales of Diastat. Diastat is the only
product approved in the United States for the acute treatment of
seizures associated with epilepsy outside of a hospital setting.
Diastat is safe and effective and has significant quality-of-life
and cost advantages. We intend to expand sales of Diastat by
promoting to our targeted physicians the benefits of including
Diastat as part of the standard treatment regimen for their
epilepsy patients.
• Leverage Our Existing Neurology Sales Organization. We intend to
leverage our 80-person field sales organization by acquiring
additional products that can be marketed to our targeted neurologist
audience.
• Acquire Products in Other Focused Markets. We seek to acquire
products that can be marketed to concentrated groups of
high-prescribing physicians in focused therapeutic markets in
addition to neurology.
• Maximize Value of Products by Developing Product Enhancements. We
intend to expand our sales by developing product enhancements, such
as new delivery systems, new formulations and new dosage strengths,
and by conducting targeted post-approval clinical studies. We
currently are analyzing the results from two post-approval clinical
studies for Diastat to obtain additional clinical data about the
product and its usefulness in treating epileptic seizures among
adults and seizures among children caused by high fever.
Our headquarters are located at 6363 Greenwich Drive, Suite 100, San Diego,
California 92122 and our telephone number is (858) 202-2700. Our web site
address is www.xcelpharmaceuticals.com. The information on our web site is not a
part of this prospectus.
We have pending a U.S. trademark application for Xcel Pharmaceuticals™. We also
own the registered trademarks Diastat and Mysoline. All other trademarks and
trade names referred to in this prospectus are the property of their respective
owners.
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The Offering
Common stock offered shares
Common stock to be sold to Elan
concurrent with the closing of this
offering shares
Common stock outstanding after this
offering shares
Use of proceeds For general corporate purposes,
including product acquisitions and
working capital.
Proposed Nasdaq National Market symbol "XCEL"
The common stock to be outstanding after this offering is based on 18,728,975
shares of common stock outstanding as of December 31, 2001, assuming conversion
of all outstanding shares of our convertible preferred stock. This table
excludes:
• 345,500 shares of our common stock issuable upon exercise of
options outstanding under our stock option plan as of December
31, 2001 at a weighted average exercise price of $0.68 per
share; and
• 925,525 additional shares of our common stock reserved for
grant as of December 31, 2001 under our stock option plan.
Except as otherwise indicated, information in this prospectus is based on the
following assumptions:
• the conversion of all outstanding shares of our convertible
preferred stock into 14,000,000 shares of common stock upon
the closing of this offering;
• the filing of an amended and restated certificate of
incorporation upon the closing of this offering;
• the purchase by Elan Corporation, plc or one of its affiliates
concurrent with the closing of this offering of shares
of our common stock (we refer to Elan and its affiliates in this
prospectus as Elan); and
• no exercise of the underwriters' over-allotment option.
Prior to this offering, our relationship with Elan consisted of the following:
• Elan sold us our two products, Diastat and Mysoline;
• Elan provided $99 million of financing for the purchase of
our products, a $10 million line of credit and product
financing whereby Elan makes payments to us based on a
percentage of net sales of its product Zanaflex and we make
payments to Elan based on a percentage of net sales of
Mysoline;
• Elan purchased 3,000,000 shares of our preferred stock at the
same price and on the same terms as all other investors. These
shares, together with 30,000 shares subject to an option that we
have issued to Elan in connection with the election of its
nominee to our board of directors, are all of the shares of our
capital stock beneficially owned by Elan and represent 16.2% of
our outstanding capital stock on a fully-diluted basis;
• Elan has the right to nominate one of our seven directors, and
we and our principal stockholders have agreed to use our best
efforts to elect Elan's nominee to our board of directors for so
long as we continue to have outstanding indebtedness to Elan;
and
• Elan agreed to purchase shares of our stock concurrent
with the closing of this offering.
After this offering, Elan will beneficially own shares of our
common stock, or % of our outstanding capital stock on a fully-diluted
basis.
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Summary Financial Data
The following table sets forth our summary financial data. You should read this
information together with the financial statements and related notes appearing
elsewhere in this prospectus and the information under "Selected Financial Data"
and "Management's Discussion and Analysis of Financial Condition and Results of
Operations."
Period from
January 24, 2001
(inception) through December 31, 2001(1)
(in thousands, except per share data)
Statement of Operations Data:
Net sales $ 14,124
Total operating costs and expenses 20,317
Operating loss (6,193 )
Net interest expense (3,323 )
Net loss $ (9,516 )
Pro forma net loss per common share-basic and diluted(2) $ (2.12 )
Pro forma weighted average common shares outstanding(2) 4,487
Unaudited adjusted pro forma net loss per common share
assuming conversion
of preferred stock-basic and diluted(3) $ (0.60 )
Unaudited adjusted pro forma weighted average common
shares outstanding
assuming conversion of preferred stock(3) 15,777
As of December 31, 2001
Actual Pro Forma As Adjusted(4)
(in thousands, except per share data)
Balance Sheet Data:
Cash and cash equivalents $ 19,487 $
Working capital 16,093
Total assets 171,906
Long-term debt 99,000
Accumulated deficit (9,516 )
Total stockholders' equity 60,382
(1) We acquired Diastat on March 31, 2001 and Mysoline on
April 1, 2001 and the related operations are included in
our results since April 1, 2001.
(2) See note 1 to our financial statements for an explanation
of the number of shares used in computing pro forma net
loss per common share.
(3) The unaudited adjusted pro forma net loss per common share
assuming conversion of preferred stock and the related
weighted average common shares outstanding reflect the
conversion of all outstanding shares of our convertible
preferred stock into 14,000,000 shares of common stock
upon the closing of this offering.
(4) The pro forma as adjusted balance sheet data gives effect to:
• the conversion of all outstanding shares of our convertible
preferred stock into 14,000,000 shares of common stock upon
the closing of this offering;
• the sale of shares of common stock in this offering
at the initial offering price of $ per share, which is
the midpoint of our expected public offering range, after
deducting the underwriting discounts and commissions and
estimated offering expenses; and
• the sale of shares of common stock to Elan
concurrent with the closing of this offering at the initial
public offering price.
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