Company Overview
| Company Name |
HORIZON PHARMA, INC. |
| Company Address |
520 LAKE COOK ROAD
SUITE 520
DEERFIELD, IL 60062 |
| Company Phone |
224-383-3000 |
| Company Website |
www.horizonpharma.com |
| CEO |
Timothy P. Walbert |
| Employees (as of 12/31/2011) |
164 |
| State of Inc |
DE |
| Fiscal Year End |
12/31 |
| Status |
Priced (9/20/2012) |
| Symbol |
HZNP |
| Exchange |
Nasdaq National Market |
| Share Price |
$3.50 |
| Shares Offered |
21,425,000 |
| Offer Amount |
$74,987,500.00 |
| Total Expenses |
$375,000.00 |
| Shares Over Alloted |
0 |
| Shareholder Shares Offered |
-- |
| Shares Outstanding |
56,574,417 |
| Lockup Period (days) |
180 |
| Lockup Expiration |
3/19/2013 |
| Quiet Period Expiration |
10/30/2012 |
| CIK |
0001492426 |
We estimate that the net proceeds from the sale of an aggregate of
21,425,000 units that we are offering will be approximately $70,238,250, or
approximately $80,811,488 if the underwriters exercise in full their
overallotment option to purchase up to 3,213,750 additional units, after
deducting the underwriting discount and estimated offering expenses payable
by us and excluding the proceeds, if any, from the exercise of the warrants
issued pursuant to this offering.
We intend to use the net proceeds from this offering primarily to fund
commercialization activities for DUEXIS and RAYOS in the United States and
for other general corporate purposes, including research and development
expenses, general and administrative expenses, manufacturing expenses and
potential acquisitions of companies and/or technologies that complement our
business. We anticipate the net proceeds from this offering and our existing
cash and cash equivalents, together with interest thereon, will be sufficient
to fund our operations through 2013. The amounts and timing of these
expenditures and whether and when we will need to raise additional capital
will depend on a number of factors, such as our future sales revenue and
expenses, the timing and progress of our research and development efforts,
the timing and progress of any partnering efforts, the possibility of early
maturity of our senior secured loan or requirements to prepay all or part of
the outstanding balance of our senior secured loan and our ability to comply
with the covenants and obligations under our senior secured loan. As of the
date of this prospectus supplement, we cannot specify with certainty all of
the particular uses for the net proceeds to us from this offering.
Accordingly, our management will have broad discretion in the application of
these net proceeds. Pending application of the net proceeds as described
above, we intend to invest the net proceeds in investment-grade,
interest-bearing instruments.
Our industry is highly competitive and subject to rapid and significant
technological change. Our potential competitors include large pharmaceutical
and biotechnology companies, specialty pharmaceutical companies and generic
drug companies, although we are not currently aware of any other delayed
release prednisone drug or ibuprofen/famotidine combination drug in
development. We believe that the key competitive factors that will affect the
development and commercial success of DUEXIS and LODOTRA/RAYOS, as well as
future drug candidates that we may develop, are efficacy, safety and
tolerability profile, convenience in dosing, price and reimbursement.
DUEXIS
DUEXIS competes with other branded NSAIDs, including Celebrex, marketed by
Pfizer Inc., Vimovo, developed by Pozen Inc. and marketed by AstraZeneca AB,
and Arthrotec, marketed by Pfizer.
Celebrex is an NSAID that selectively inhibits the COX-2 enzyme and is an
effective anti-arthritic agent that reduces the risk of ulceration compared
to traditional NSAIDs such as ibuprofen. However, two other COX-2 inhibitors,
Vioxx and Bextra, have been withdrawn from the market due to safety concerns.
Vimovo is a fixed-dose combination of enteric-coated naproxen plus
esomeprazole, a PPI. Enteric-coated naproxen is an NSAID indicated for the
treatment of OA and esomeprazole is approved to reduce the risk of
NSAID-induced gastric ulcers. We believe DUEXIS may offer competitive
advantages over Vimovo due to its delayed onset of pain relief related to the
enteric-coated naproxen as well as several recent publications highlighting
safety concerns with long-term PPI use.
Arthrotec is a fixed-dose combination of diclofenac sodium and misoprostol, a
GI mucosal protective prostaglandin E1 analog. Diclofenac sodium is an NSAID
prescribed for pain relief and misoprostol is used to reduce the risk of
NSAID-induced upper GI ulcers. We believe DUEXIS may offer competitive
advantages over Arthrotec based on a significant increase in GI side effects,
including abdominal pain and diarrhea, associated with Arthrotec. Rare
instances of profound diarrhea leading to severe dehydration have been
reported in patients receiving misoprostol. Arthrotec has additional safety
issues associated with its components such as cases of hepatic-related
adverse events, none of which have been observed in our clinical trials of
DUEXIS. In addition, misoprostol has been associated with miscarriage in
pregnant women and is contraindicated in those women who are pregnant or
likely to become pregnant.
In general, DUEXIS will also face competition from the separate use of NSAIDs
for pain relief and ulcer medications to address the risk of NSAID-induced
ulcers. Use of these therapies separately in generic form may be cheaper than
we expect to offer DUEXIS. In addition, physicians could begin to prescribe
both an NSAID and a GI protectant to be taken together but in separate pills.
We expect to compete with the separate use of NSAIDs and ulcer medications
primarily through DUEXIS’ advantages in dosing convenience and patient
compliance, and by educating physicians about such advantages, including
through funding we have provided for the American Gastroenterology
Association, or AGA, to help physicians and patients better understand and
manage NSAID risks. We expect DUEXIS will be the only product containing a
histamine-2 receptor antagonist with an indication to reduce the risk of
NSAID-induced upper GI ulcers.
LODOTRA/RAYOS
LODOTRA/RAYOS competes in Europe and will compete in the U.S., if approved,
with a number of products on the market to treat RA, including
corticosteroids, such as prednisone, traditional DMARDs, such as methotrexate
and biologic agents, such as HUMIRA and Enbrel. The majority of RA patients,
however, are treated with DMARDs. DMARDs, such as methotrexate, are typically
used as initial therapy in patients with RA whereas biologic agents are
typically added to DMARDs as combination therapy. It is common for an RA
patient to take a combination of a DMARD, an oral glucocorticoid, an NSAID
and/or a biologic agent.
Company Description
We are a biopharmaceutical company that is developing and commercializing
innovative medicines to target unmet therapeutic needs in arthritis, pain and
inflammatory diseases. On April 23, 2011, the U.S. Food and Drug
Administration, or FDA, approved DUEXIS®, a proprietary tablet formulation
containing a fixed-dose combination of ibuprofen and famotidine in a single
pill. DUEXIS is indicated for the relief of signs and symptoms of rheumatoid
arthritis, or RA, and osteoarthritis and to decrease the risk of developing
upper gastrointestinal ulcers in patients who are taking ibuprofen for these
indications. In the second half of 2011, we hired our initial commercial
organization and completed sales force training, and we began detailing
DUEXIS to physicians in December 2011 and held our launch meeting for DUEXIS
in the U.S. in January 2012. In June 2012, we began expanding our commercial
organization and expect to almost double its original size by the end of the
third quarter of 2012 to approximately 150 field sales representatives. In
June 2012, we also engaged Mallinckrodt LLC, the pharmaceutical business of
Covidien plc, on a non-exclusive basis to co-promote DUEXIS in the U.S. and
entered into an exclusive collaboration, license and supply agreement with
Grünenthal S.A. for the potential commercialization of DUEXIS in Latin
America. In October 2010, we submitted a Marketing Authorization Application,
or MAA, for DUEXIS in the United Kingdom, or UK, the Reference Member State,
through the Decentralized Procedure. In February 2012, we withdrew and
updated the DUEXIS MAA submission to include the recently approved
manufacturing site in Laval, Quebec through the National Procedure in the UK.
We anticipate a decision on the MAA in the second half of 2012.
Our second product, RAYOS®, known as LODOTRA® outside the U.S., is a
proprietary programmed release formulation of low-dose prednisone that is
currently marketed in Europe by our distribution partner, Mundipharma
International Corporation Limited, or Mundipharma, for the treatment of
moderate to severe, active RA in adults when accompanied by morning stiffness.
In addition, we have granted to Mundipharma commercialization rights to
LODOTRA in Asia and Latin America. On July 26, 2012, the FDA approved RAYOS
for the treatment of a broad range of diseases including RA, polymyalgia
rheumatica, or PMR, psoriatic arthritis, ankylosing spondylitis, asthma and
chronic obstructive pulmonary disease. We expect to commence commercial sales
of RAYOS in the U.S. for rheumatologic diseases such as RA and PMR during the
fourth quarter of 2012. Our strategy is to commercialize our products in the
U.S. and to enter into licensing or additional distribution agreements for
commercialization of our products outside the U.S.
We were incorporated in Delaware on March 23, 2010. On April 1, 2010, we
became a holding company that operates primarily through our two wholly-owned
subsidiaries, Horizon Pharma USA, Inc., a Delaware corporation, and Horizon
Pharma AG, a company organized under the laws of Switzerland. Horizon Pharma
AG owns all of the outstanding share capital of its wholly-owned subsidiary,
Horizon Pharma GmbH, a company organized under the laws of Germany and
formerly known as Nitec Pharma GmbH, through which Horizon Pharma AG conducts
most of its European operations.
Our headquarters are located at 520 Lake Cook Road, Suite 520, Deerfield,
Illinois 60015. Our telephone number is (224) 383-3000. We maintain an
Internet website at www.horizonpharma.com.