UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
(RULE 14a-101)
SCHEDULE 14A INFORMATION
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
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x | Soliciting Material Pursuant to 240.14a-12 |
Horizon Pharma, Inc.
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
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Filed under Rule 14a-12
of the Securities Exchange Act of 1934
Filing by: Horizon Pharma, Inc.
Subject Company: Horizon Pharma, Inc.
SEC File No. of Horizon Pharma, Inc.: 001-35238
This Schedule 14A filing consists of a presentation that will be used by Horizon Pharma, Inc. (Horizon) in investor meetings and conferences beginning on June 23, 2014. Certain information contained in the presentation relating to Vidara Therapeutics International Ltd. (Vidara) and ACTIMMUNE® has been provided by Vidara.
Forward Looking Statements
The presentation contains forward-looking statements, including, but not limited to, statements related to the anticipated consummation of a business combination transaction between Horizon and Vidara and the timing and benefits thereof, Horizons and the combined companys strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product portfolio, development programs and management structure, and other statements that are not historical facts. These forward-looking statements are based on Horizons current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Horizons ability to complete the transaction with Vidara on the proposed terms and schedule; risks associated with business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks related to future opportunities and plans for Horizon, as well as the combined company, including uncertainty of the expected financial performance and results; disruption from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the calculations of, and factors that may impact the calculations of, the acquisition price in connection with the proposed merger and the allocation of such acquisition price to the net assets acquired in accordance with applicable accounting rules and methodologies; and the possibility that if the combined company does not achieve the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of the combined companys shares could decline, as well as other risks related to Horizons business, including Horizons dependence on sales of DUEXIS and VIMOVO and its ability to increase sales of its DUEXIS, VIMOVO and RAYOS/LODOTRA products; competition, including potential generic competition; the ability of Horizon to protect its intellectual property and defend its patents; regulatory obligations and oversight; and those risks detailed from time-to-time under the caption Risk Factors and elsewhere in Horizons SEC filings and reports, including in its Annual Report on Form 10-K for the year ended December 31, 2013. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in its expectations.
Additional Information and Where to Find It
In connection with the proposed transaction with Vidara, Horizon and Vidara will be filing documents with the SEC, including the filing by Horizon of a preliminary and definitive proxy statement/prospectus relating to the proposed transaction and the filing by Vidara of a registration statement on Form S-4 that will include the proxy statement/prospectus relating to the proposed transaction. After the registration statement has been declared effective by the SEC, a definitive proxy statement/prospectus will be mailed to Horizon stockholders in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT ON FORM S-4 AND THE RELATED PRELIMINARY AND DEFINITIVE PROXY/PROSPECTUS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT HORIZON, VIDARA AND THE PROPOSED TRANSACTION. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SECs web site at www.sec.gov, by directing a request to Horizons Investor Relations department at Horizon Pharma, Inc., Attention: Investor Relations, 520 Lake Cook Road, Suite 520, Deerfield, IL 60015 or to Horizons Investor Relations department at 224-383-3000 or by email to investor-relations@horizonpharma.com. Investors and security holders may obtain free copies of the documents filed with the SEC on Horizons website at www.horizonpharma.com under the heading Investors and then under the heading SEC Filings.
Horizon and its directors and executive officers and Vidara and its directors and executive officers may be deemed participants in the solicitation of proxies from the stockholders of Horizon in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed transaction will be included in the proxy statement/prospectus described above. Additional information regarding the directors and executive officers of Horizon is also included in Horizons Annual Report on Form 10-K for the year ended December 31, 2013, which was filed with the SEC on March 13, 2014. These documents are available free of charge at the SECs web site at www.sec.gov and from Investor Relations at Horizon as described above.
This communication does not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to subscribe for or buy, any securities nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
NASDAQ:
HZNP June 2014
Filed under Rule 14a-12 of the Securities Exchange Act of 1934
Filing by: Horizon Pharma, Inc.
Subject Company: Horizon Pharma, Inc.
SEC File No. of Horizon Pharma, Inc.: 001-35238
The following is a slide presentation relating to the proposed transactions
described therein that was made available beginning on June 23, 2014.
Horizon Pharma, Inc. |
Forward-Looking
Statements 2
This presentation contains forward-looking statements, including, but not limited to,
statements related to the anticipated consummation of a business combination
transaction between Horizon Pharma and Vidara Therapeutics and the timing and benefits thereof, Horizon Pharmas
and the combined companys strategy, plans, objectives, expectations (financial or
otherwise) and intentions, future financial results and growth potential, anticipated
product portfolio, development programs and management structure, and other statements that are not
historical facts. These forward-looking statements are based on Horizon
Pharmas current expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as
a result of these risks and uncertainties, which include, without limitation, risks related to
Horizon Pharmas ability to complete the transaction with Vidara on the proposed
terms and schedule; risks associated with business combination transactions, such as the risk that the businesses
will not be integrated successfully, that such integration may be more difficult,
time-consuming or costly than expected or that the expected benefits of the
transaction will not occur; risks related to future opportunities and plans for Horizon Pharma, as well as the combined
company, including uncertainty of the expected financial performance and results; disruption
from the proposed transaction, making it more difficult to conduct business as usual or
maintain relationships with customers, employees or suppliers; the calculations of and factors that
may impact the calculations of, the acquisition price in connection with the proposed merger
and the allocation of such acquisition price to the net assets acquired in accordance
with applicable accounting rules and methodologies; and the possibility that if the combined company
does not achieve the perceived benefits of the proposed transaction as rapidly or to the
extent anticipated by financial analysts or investors, the market price of the combined
companys shares could decline, as well as other risks related to Horizon Pharmas business, including
Horizon Pharmas dependence on sales of DUEXIS and VIMOVO and its ability to increase
sales of its DUEXIS, VIMOVO and RAYOS/LODOTRA products; competition, including
potential generic competition; the ability of Horizon Pharma to protect its intellectual property and defend its
patents; regulatory obligations and oversight; and those risks detailed from
time-to-time under the caption Risk Factors and elsewhere in
Horizon Pharma's SEC filings and reports, including in its Annual Report on Form 10-K for
the year ended December 31, 2013. Horizon Pharma undertakes no duty or obligation
to update any forward-looking statements contained in this presentation as a result of new information,
future events or changes in its expectations. |
Additional
Information 3
In connection with the proposed transaction, Horizon Pharma and Vidara Therapeutics will be
filing documents with the SEC, including the filing by Horizon Pharma of a preliminary
and definitive proxy statement/prospectus relating to the proposed transaction and the
filing by Vidara Therapeutics of a registration statement on Form S-4 that will include the
proxy statement/prospectus relating to the proposed transaction. After the registration
statement has been declared effective by the SEC, a definitive proxy
statement/prospectus will be mailed to Horizon Pharma stockholders in connection with
the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT
ON FORM S-4 AND THE RELATED PRELIMINARY AND DEFINITIVE PROXY/PROSPECTUS WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT HORIZON PHARMA, Vidara
THERAPEUTICS AND THE PROPOSED TRANSACTION. Investors and security holders may
obtain free copies of these documents (when they are available) and other related
documents filed with the SEC at the SECs web site at www.sec.gov, by directing a request to
Horizon Pharmas Investor Relations department at Horizon Pharma, Inc., Attention:
Investor Relations, 520 Lake Cook Road, Suite 520, Deerfield, IL 60015 or to Horizon
Pharmas Investor Relations department at 224-383-3000 or by email to
investor-relations@horizonpharma.com. Investors and security holders may obtain free
copies of the documents filed with the SEC on Horizon Pharmas website at
www.horizonpharma.com under the heading Investors and then under the
heading SEC Filings.
Horizon Pharma and its directors and executive officers and Vidara Therapeutics
and its directors and executive officers may be deemed participants in the solicitation
of proxies from the stockholders of Horizon Pharma in connection with the proposed
transaction. Information regarding the special interests of these directors and executive officers in the proposed
transaction will be included in the proxy statement/prospectus described above.
Additional information regarding the directors and executive officers of Horizon Pharma
is also included in Horizon Pharmas Annual Report on Form 10-K for the year
ended December 31, 2013, which was filed with the SEC on March 13, 2014. These documents are available free of
charge at the SECs web site at www.sec.gov and from Investor Relations at Horizon Pharma
as described above.
This communication does not constitute an offer to sell, or the solicitation of an offer to
sell, or the solicitation of an offer to subscribe for or buy, any securities nor shall
there be any sale, issuance or transfer of securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any
such jurisdiction.
For full prescribing information refer to product websites. |
Note Regarding Use
of Non-GAAP Financial Measures 4
Horizon Pharma provides non-GAAP net income (loss) and net income (loss) per share
financial measures that include adjustments to GAAP figures. These adjustments to
GAAP exclude non-cash items such as stock compensation and depreciation and amortization, non-
cash interest expense, and other non-cash charges. Certain one-time or
substantive events may also be included in the non-GAAP adjustments periodically
when their magnitude is significant within the periods incurred. EBITDA, or earnings before interest, taxes,
depreciation and amortization, is also used and provided by Horizon Pharma as a non-GAAP
financial measure. Horizon Pharma believes that these non-GAAP financial
measures, when considered together with the GAAP figures, can enhance an overall understanding of
Horizon Pharmas financial performance. The non-GAAP financial measures are
included with the intent of providing investors with a more complete understanding of
operational results and trends. In addition, these non-GAAP financial measures are among the
indicators Horizon Pharmas management uses for planning and forecasting purposes and
measuring Horizon Pharmas performance. These non-GAAP financial
measures should be considered in addition to, and not as a substitute for, or superior to, financial measures
calculated in accordance with GAAP. The non-GAAP financial measures used by Horizon
Pharma may be calculated differently from, and therefore may not be comparable to,
non-GAAP financial measures used by other companies. |
(1)
On a non-GAAP basis
(2)
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer (3)
RAYOS is known as LODOTRA outside the United States
Profitable
(1)
, specialty pharma company with accelerating growth
Integrated commercial model with analytics as its foundation
Four
products
targeting
unmet
therapeutic
needs
in
primary
care,
orphan
diseases
(2)
and specialty segments
VIMOVO
®
(naproxen/esomeprazole)
DUEXIS
®
(ibuprofen/famotidine)
ACTIMMUNE
®
(interferon gamma 1b)
(2)
RAYOS
®
(prednisone) delayed-release tablets
(3)
Tax efficient corporate platform facilitating an aggressive business
development strategy via product/company acquisitions
(2)
Proven leadership team
5
Horizon Pharma Overview |
Accelerating Growth
in Revenues and EBITDA 6
~497% Year-over-Year
Net Sales Growth
2011
2012
2013
2014E
(1)
1Q 2013
1Q 2014
$6.9
$18.8
$74.0
$275.0
$8.7
$51.9
$(46.8)
$(73.3)
$(33.5)
$(16.6)
$11.0
$(150.0)
$(100.0)
$(50.0)
$-
$50.0
$100.0
$150.0
$200.0
$250.0
$300.0
Net Sales
Adjusted EBITDA
(1)
Midpoint of 2014 guidance provided on May 9, 2014 for net sales of $270 - $280
million and adjusted EBITDA of $80 - $90 million which included ACTIMMUNE results for the
assumed period of August through December 2014 and excluded transaction related expenses. By
this presentation, Horizon is not confirming or updating its May 9, 2014 financial
guidance.
$85.0 |
7
Integrated Commercial Model
Leading-Edge, Value-Based Analytics
Differentiated
Sales Approach
Do What is Right
for the Patient
Optimize
Value
Prescriptions
Made Easy
Rep profile
B2B
Funnel
management
Optimized targeting
Total office and
pharmacy call
Uncapped incentives
$0 co-pay program
Ensure ubiquity
Align WAC and
co-pay
Maximize net
revenues
Understand the
interplay of
pricing, managed
care control and
script volume
Eliminate script
fulfillment friction
Specialty pharmacy
channel
HZNP guarantees
reimbursement |
Integrated
Commercial Model (continued) DUEXIS Unique Prescribers and Adopters Continue to
Grow 8
Added 200+ new writers every week for last 20 months
(1)
Source: IMS Xponent data
Number of Unique Writers
(1)
13% increase over last 3 months
Number of Unique Adopters (5+ TRx)
(1)
19% increase over last 3 months
Unique Prescribers
+13% Over Last 3 Months
and Unique
Adopters (5+ Rx/week) +19% Over Last 3 Months
|
~35% of DUEXIS
Prescriptions Through PME (May 2014) Rx Filled
Refill Rate
(May
2014)
(2)
Fill Rate
(1)
9
Prescriptions-Made-Easy
(PME) Specialty
Pharmacy Program Driving Prescriptions
2013
2014
(1)
National Average fill rate calculated by subtracting IMS Monthly Claims national average
rejections and reversals from total patients that had a claim adjudicated (1
rejections reversals) and Pharmacy Pilot fill rate based on total patients contacted by the pharmacy that provide
insurance information and fill their prescription (total patients that fill Rx / total
patients that are contacted and have insurance information)
(2)
National Average refill rate based on IMS NPA Monthly
|
Primary
Care Orphan Diseases
10
Four US Products in Three Market Segments
(1)
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer (2)
RAYOS is known as LODOTRA outside of the United States
(1)
Specialty
250 sales reps
PCPs
Ortho surgeons
Podiatrists
Six sales reps
40 sales reps
Rheumatologists
(2)
Academic medical
centers
Family Practice ID and
Immunology |
11
(1)
Singh and Rosen Ramey. J Rheumatol. 1998;51(suppl):816.
(2)
Geis et al. J Rheumatol. 1996;18:1114
(3)
M.Wolfe, et.al.; Gastrointestinal Toxicity of Nonsteroidal Anti-inflammatory Drugs; NEJM;
vol. 340; no. 24; June 1999. (4)
BMC Musculoskeletal Disorders 2006, 7:79
(5)
Sturkenboom, et.al.; Aliment Pharmacol Ther 2003; 18:1137-1147
GI intolerance incidence: up to 50%
(1)
Endoscopic ulcers incidence: 15-46%
(2)
Leads to 107k hospitalizations and 16.5k deaths
per year
(3)
76% of MDs do not prescribe concomitant GI
therapy
(4)
37% of patients non-compliant; increased to
61% by the 3rd prescription
(5)
Novel, proprietary formulations of two of the most prescribed
NSAIDs combined with a GI protectant in a single pill
NSAID-INDUCED
GI TOXICITY
POOR PHYSICIAN AND
PATIENT COMPLIANCE
VIMOVO
VIMOVO
DUEXIS
DUEXIS
Naproxen
NSAID
Ibuprofen
Esomeprazole
magnesium (PPI)
GI
Protectant
Famotidine
(H2
antagonist)
BID
Dosing
TID
VIMOVO & DUEXIS
Addressing an Unmet Medical Need |
VIMOVO as the
Smarter Naproxen There is only ~30% TRx overlap of
VIMOVO
and
DUEXIS
prescribers
(1)
VIMOVO
Prescribers
DUEXIS
DUEXIS
Prescribers
Prescribers
Weekly New Rx (k)
Product Positioning
Minimal Overlap with
Existing Targets
Underlying Market Potential
leading to limited overlap in existing
writers of VIMOVO and DUEXIS
The market potential for ibuprofen and
naproxen underlying NSAID is large,
segmented, and largely untapped
VIMOVO and DUEXIS
are
highly synergistic and meet different
patient needs
12
Significant Market Opportunity for both
VIMOVO and DUEXIS with Minimal Overlap
Focus on HCPs that need an NSAID,
but are also concerned with
protection
(gold-standard protection,
etc.)
Focus on underlying Naproxen
prescribers
Focus on HCPs that need best-in-
class pain relief and protection
(rapid onset, gold standard
efficacy, etc.)
Focus on underlying Ibuprofen
prescribers
DUEXIS as the Smarter Ibuprofen
(1)
Source: Healthcare Analytics (SHA) Prescriber Level Data from June 2013 August
2013 |
(naproxen/esomeprazole magnesium)
Delayed-Release Tablets
375/20 and 500/20 mg
Indicated for the relief of signs and symptoms of osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis and to decrease the
risk of developing gastric ulcers in patients at risk of developing
NSAID-associated gastric ulcers
See
full
prescribing
information
at
www.vimovo.com |
Highly Synergistic
VIMOVO Acquisition (1)
AstraZeneca Annual Reports
Product Highlights
Product Highlights
Acquired Nov. 18, 2013 from
AstraZeneca
$35 million one time payment
Leverages existing commercial
infrastructure
Focus on commercial payors
Maximizing value through price and
lower patient co-pay
Rapid growth in VIMOVO revenues
14
Net Sales
Net Sales
(1)
(1)
Perfect example of value arbitrage we are trying to capture in our BD strategy
|
VIMOVO Off to
Strong Start in 2014 LARGE MARKET
OPPORTUNITY
COMMERCIAL
DYNAMICS
EXECUTION
Large NSAID market
(>100M TRx/year)
Naproxen NSAID in
U.S. with over 16M
TRx/year
Peak annual
VIMOVO demand of
~600k scripts and
run rate of ~300k
scripts at YE13
Branded NSAIDs in Tier
3 position
VIMOVO priced at
monthly WAC of $799,
WAC/TRx of ~$820
84% of claims
approved
$0 target co-pay
May 2014 NRx +2% vs.
April 2014
May 2014 TRx +4% vs.
April 2014
May 2014 TRx dollars
of ~$21.6M
April 2014 TRx dollars
of ~$20.8M
15
250 Primary Care Reps + 40 Specialty Reps Selling VIMOVO
HZNP
Full Launch of VIMOVO on February 3, 2014
Source: IMS NPA Monthly data; IMS Claims data Commercial Only
|
For the relief of
signs and symptoms of rheumatoid arthritis and osteoarthritis and to
decrease the risk of developing upper
gastrointestinal ulcers in patients who are taking
ibuprofen for those indications
See
full
prescribing
information
at
www.DUEXIS.com |
DUEXIS Scripts
Continue to Grow 250 Sales Reps Promoting to Primary Care and ORS
17
LARGE MARKET
OPPORTUNITY
MANAGED
CARE
EXECUTION
Large NSAID market
(100M+ TRx/year)
Ibuprofen is leading
NSAID in U.S. with
over 33M TRx/year
Branded NSAIDs in Tier
3 position
Monthly WAC of $799,
average WAC/Rx of
~$720
82% of claims
approved
$0 target co-pay
NRx/TRx continue to
grow
May 2014 TRx +8% vs.
April 2014
May 2014 NRx +6% vs.
April 2014
May TRx dollars of
~$16.8M
April TRx dollars of
~$15.7M
Source: IMS Xponent data; IMS Claims data - Commercial Only |
DUEXIS
Quarterly
Net Sales Growth ($M)
Sales Force
Expansion
TRx
NRx
Price Increase
from $198 WAC
to $502 WAC
Price Increase
from $502 WAC
to $677 WAC
Price Increase
from $677 WAC
to $799 WAC
18
DUEXIS
Monthly
TRx and NRx
(2)
(1)
DUEXIS Scripts Continue to Grow (continued)
DUEXIS Scripts Continue to Grow (continued)
Source: IMS Xponent
Data
(1)
Includes one-time amount of $1.4M due to change in timing of revenue
recognition.
(2)
Includes one time reversal of managed care rebate in the amount of $2.4M |
For reduction of
the frequency and severity of serious infections associated with Chronic Granulomatous
Disease and for delaying time to disease progression in patients with severe, malignant
osteopetrosis (Interferon gamma-1b)
Injection
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer See
full
prescribing
information
at
www.actimmune.com |
On March 19, 2014, announced the acquisition of Vidara Therapeutics
International Ltd. for 31.35 million shares of Horizon stock, $200 million in cash
and plan to become Horizon Pharma plc
Closing is currently projected to be this summer
ACTIMMUNE
Recombinant biologic approved in two ultra orphan indications, CGD and SMO
Realized $58.9 million in net revenues in 2013
Commercial rights in U.S., Canada, Japan and certain LA, Asian and other ROW
territories
Two U.S. patents extending to 2022; perpetual Genentech know-how license
Potential for label expansion, including Friedreichs ataxia and eczema herpeticum
Total headcount of 24, including 6 sales reps with biologic and orphan
experience
Horizon Pharma plc
corporate structure
Corporate headquarters: Dublin, Ireland
Bermuda headquarters: Hamilton (IP & BLA)
U.S. headquarters: Deerfield, IL
20
Vidara Therapeutics Acquisition Overview
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer |
Pricing
Currently priced at $308K per patient per year
Pricing analyses in process to determine optimal pricing strategy
Penetration
CGD and SMO penetration is <25%
Opportunity to increase penetration rates with increased commitment to selling
and marketing
New Presentations/Formulations
~25% of scripts are for Medicaid covered patients
$0.01 sales price per vial
New presentation/formulation
reestablish value-based pricing with Medicaid
New Indications
12 patient trial in Freidrichs Ataxia reading out in 2H:14
Eczema herpeticum
21
Growth Potential for ACTIMMUNE
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer |
Delayed-Release Low-Dose Prednisone approved in the U.S. for treatment of
Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriatic Arthritis, Ankylosing
Spondylitis, Asthma and Chronic Obstructive Pulmonary Disease*
(prednisone)
Delayed-Release Tablets
Note: RAYOS is known as LODOTRA outside the United States
*For full
list
of
indications,
see
full
prescribing
information
at:
www.RAYOSrx.com |
RAYOS Commercial
Overview HIGH UNMET NEED IN
RA & PMR
COMMERCIAL
DYNAMICS
EXECUTION
1.8M RA Patients,
majority suffer from
morning symptoms
1.1M PMR Patients,
majority suffer from
morning symptoms
~10M annual TRx
~3M annual
prednisone Rxs
40 Rheum Specialists
calling on 3,000+
rheumatologists
May 2014 TRx +4% vs.
April 2014
May 2014 NRx -1% vs.
April 2014
May TRx dollars of
~$1.72M
April TRx dollars of
~$1.67M
May 2014 TRx +4% vs. April 2014
Note: RAYOS is known as LODOTRA outside the United States
23
Source: IMS NPA Monthly data; IMS Claims data - Commercial Only
Majority Tier 3
position
RAYOS priced at $933
WAC per 30-count
bottle, WAC per Rx of
$1,600
88% of claims
approved
$0 target co-pay |
24
DUEXIS
6 issued U.S. patents
Settled Par Pharmaceutical PIV litigation by granting a non-exclusive right to market a
generic product beginning January 1, 2023, or earlier under certain circumstances
VIMOVO
8 issued U.S. patents with protection to at least 2022
Five generic companies have filed ANDA PIV against VIMOVO
o
Dr. Reddys non-infringement challenge in court system (Pisano, NJ)
o
Court ordered mediation is in process (no trial date set)
RAYOS
5 issued U.S. patents with protection to at least 2024
Horizon responded to a PIV Patent Certification received from Watson on July 15, 2013 by
filing a patent
infringement
lawsuit
against
Watson
on
Aug.
27,
2013
in
New
Jersey
no
trial
date
set
ACTIMMUNE
(1)
Two U.S. patents extending to 2022; perpetual Genentech know-how license
Long Life Proprietary Products
(1)
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer |
President &
CEO, IDM Pharma
(Orphan/Osteosarcoma;
sold to Takeda)
Todd Smith
EVP, Chief Commercial
Officer
Agouron, Achillion, Abbott,
Bayer, Fenwal
VP/GM, Abbott
Immunology
Led global
development
&
launch
of
HUMIRA
($11+B
in
sales)
Wyeth, Searle, Merck and
Abbott
Marketed 12 NSAIDs, including
Celebrex, VIOXX, Arthrotec,
Mobic, Daypro, Brufen
Jeff Sherman, M.D.
EVP, Chief Medical Officer
BMS, Searle, Takeda, IDM Pharma
25
Proven Leadership Team
Extensive Commercial, Development and M&A Experience
Bob Carey
EVP, Chief Business Officer
JMP Securities, Dresdner Kleinwort
Wasserstein,
Vector Securities
Board
Member
Raptor
(orphan);
XOMA
(orphan)
Egalet
(opioid);
BIO
Bob De Vaere
(1)
EVP, Chief Financial Officer
IDM Pharma, Nexa Therapeutics,
Epimmune, Vista Medical
Paul Hoelscher
(1)
EVP, Finance
Chief
Financial
Officer
-
Elect
OfficeMax, Alberto Culver/Unilever,
KPMG LLC
Ben Bove
SVP,
Marketing
&
Analytics
Galt & Company, Abbott, Fenwal
Jeff Kent, M.D.
SVP, Medical Affairs
Searle (Celebrex/Bextra), Abbott
(HUMIRA)
Tim Walbert
Chairman, President & CEO
(1)
Bob De Vaere will retire , effective September 30, 2014 and enter into a one-year
consulting agreement with the Company; Paul Hoelscher will serve as Executive Vice
President, Finance, effective June 23, 2014 and Chief Financial Officer, effective October 1,
2014 |
Leverage Core
Commercial Strengths
Adjacencies to Current
Capabilities
Important Unmet Need
Pursue products with differentiated clinical benefits
U.S. products/companies with on-market assets
Leverage 250 person primary care sales force
Leverage 40 person specialty sales force
Build upon orphan presence with ACTIMMUNE
Differentiated and/or underappreciated assets with targeted
approach regardless of therapeutic area
Opportunistic targets which provide geographic expansion
Immediate accretion
Attractive financial returns
Long life assets
Maximize Shareholder
Value Creation
Business Development Strategy
26 |
($ in
millions) Period
1Q 2014 % Change from
1Q 2013
2Q 2013
3Q 2013
4Q 2013
FY 2013
1Q 2014
1Q 2013
4Q 2013
Net Sales by Product
VIMOVO
-
$
-
$
-
$
1.0
$
1.0
$
34.0
$
NM
NM
DUEXIS
4.8
9.5
21.6
23.1
59.0
13.9
190%
-40%
RAYOS
(1)
0.4
0.4
1.8
3.2
5.8
3.3
727%
3%
LODOTRA
(1)
3.5
1.2
0.7
2.8
8.2
0.7
-80%
-75%
Total Net Sales
8.7
$
11.1
$
24.1
$
30.1
$
74.0
$
51.9
$
497%
73%
Adjusted EBITDA
(3)
(16.6)
$
(13.9)
$
(0.8)
$
(1.0)
$
(32.3)
$
11.0
$
NM
NM
1Q 2014 and Full Year 2013 Results
Adjusted 1Q 2014 non-GAAP net income was $11.0 million, or $0.16 non-
GAAP basic earnings per share and $0.13 non-GAAP diluted earnings per share
(1)
RAYOS is known as LODOTRA outside the United States
(2)
Not meaningful
(3)
Adjusted EBITDA reflects adjustments for Vidara acquisition costs
27
(2) |
Adjusted
Financials Reconciliation 28
($ in thousands)
Fiscal Year Ended December 31,
Three Months Ended March 31,
2011
2012
2013
2013
2014
GAAP Net Loss
(113,265)
$
(87,794)
$
(149,005)
$
(22,171)
$
(206,250)
$
Loss on derivative revaluation
-
-
69,300
-
204,030
Intangible impairment charge
69,621
-
-
-
-
Depreciation and intangible amortization expense
4,199
5,538
9,310
1,922
5,403
Interest expense, net
6,284
14,525
39,178
3,603
4,207
Other expense, net
-
56
-
-
667
Foreign exchange loss (gain)
1,023
(489)
(1,206)
905
38
Benefit for income taxes
(14,683)
(5,171)
(1,121)
(881)
(1,105)
Non-GAAP Adjustments
66,444
$
14,459
$
115,461
$
5,549
$
213,240
$
EBITDA
(46,821)
$
(73,335)
$
(33,544)
$
(16,622)
$
6,990
$
Adjustments for Vidara acquisition costs
-
-
1,252
-
4,049
Total Non-GAAP Adjustments
66,444
14,459
116,713
5,549
217,289
Adjusted EBITDA
(46,821)
$
(73,335)
$
(32,292)
$
(16,622)
$
11,039
$ |
Adjusted Financials
Reconciliation (continued) 29
Three Months Ended
($ in thousands)
March 31,
2014
GAAP Net Loss
(206,250)
$
Loss on derivative
revaluation 204,030
Intangible amortization expense (net of tax effect)
4,680
Stock based compensation
1,927
Amortization of debt discount and deferred financing costs
2,333
Depreciation expense
376
Amortization of deferred revenue
(161)
Non-GAAP Adjustments
213,185
Non-GAAP Net Income (Loss)
6,935
$
Adjustments for Vidara acquisition costs
4,049
Total Non-GAAP Adjustments
217,234
Adjusted Non-GAAP Net Income (Loss)
10,984
$
GAAP
Net Loss per common share - basic (3.07)
$
Non-GAAP Adjustments
3.23
Adjusted Non-GAAP Basic Earnings (Loss) per Share
0.16
$
Dilutive earnings per share effect of common stock equivalents
(0.03)
Adjusted Non-GAAP Net Income (Loss) per Common Share - Diluted
0.13
$
|
(in
millions) As of 3/31/14
Pro Forma for
Vidara Acquisition
Balance Sheet
Balance Sheet
Cash
$103.4
n/a
Debt
$150.0
(1)
$450.0
(2)
Capitalization
Capitalization
(3)
(3)
Basic Shares Outstanding
71.4
102.8
Fully Diluted Shares Outstanding
(4)
90.4
121.8
Financial Highlights
30
(1)
Gross amount of 5% convertible notes outstanding, excluding debt discount (2)
Includes $300 million senior secured credit agreement; see following slide
for further details.
(3)
Includes all issued and outstanding securities, vested and unissued RSUs and contingent stock
options. Pro Forma column includes 31,350,000 shares issued to Vidara shareholders upon
closing and assumes no existing warrants, options or RSUs are exercised between 3/31/14 and closing.
(4)
Excludes shares issuable upon conversion of $150 million convertible note. |
On June 19, 2014, we announced an agreement with a group of lenders to provide Horizon
with $300 million in financing that will replace the $250 million bridge loan commitment
received from Deerfield Management Company, L.P., announced on March 19, 2014
31
Senior Secured Credit Agreement
Loan Commitment
Senior secured term loans
Size
$300 million
Term
5 years
Interest Rate
L + 8.0% (LIBOR Floor: 1.0%) or
the prime lending rate + 7.0% (at each borrowers option)
Make-whole
T+50 bps for two years and callable thereafter at a premium:
Year 3: 104, year 4: 102, year 5: 100
Amortization
None
Accordion
(1)
Unlimited subject to (i) minimum EBITDA of $70 million, (ii) maximum senior secured net
leverage ratio < 3.5x (cash netting cap of $50 million) and (iii) maximum total
net leverage ratio < 5.5x (cash netting cap of $50 million)
Timing
Coincident with the closing of the proposed acquisition of Vidara
Use of proceeds
To effect the proposed acquisition of Vidara, pay related transaction fees and expenses
and for general corporate purposes
(1)
EBITDA to reflect certain adjustments and be calculated on a Last Quarter Annualized basis for
any test period ending on or prior to June 30, 2015, after which EBITDA shall be
calculated on a Last Twelve Months Basis after giving pro forma effect to any acquisitions and dispositions that have
occurred during the test period and on or before the calculation date. |
Appendix
Appendix |
Horizon Pharma
History 33
2005
2008
2010
2011
2012
2013
Founded in Palo
Alto, CA
Relocates
to IL
DUEXIS
U.S. Approval
4-2011
$50M IPO
(NASDAQ: HZNP)
DUEXIS
U.S. Launch
$111M Raised:
$60M in Debt and
$51M in Equity
$86M Equity
Raise
RAYOS
U.S.
Approval
7-2012
RAYOS
U.S. Launch
T. Walbert
joins as CEO
Acquisition of
VIMOVO
$150M Convert
VIMOVO
HZNP
U.S. Launch
2014
Vidara
Acquisition
(1)
&
$300M Loan
(1)
Pending the closing of the acquisition of Vidara Therapeutics International Ltd. which is
expected this summer
Acquisition of private,
Switzerland-based Nitec
Pharma (RAYOS) |
VIMOVO:
Significant Reduction in Gastric Ulcers Cumulative observed incidence of Gastric
Ulcers *P<0.001 Ec Naproxen vs. VIMOVO
Source: VIMOVO Approved Package Insert, October 2012
*
*
34
4.1
23.1
7.1
24.3
0
5
10
15
20
25
30
VIMOVO
EC
Naproxen
VIMOVO
EC
Naproxen
Study 301
Study 302 |
VIMOVO: Gastric
Protection with or without Low Dose Aspirin (LDA)
Pooled Cumulative incidence of Gastric Ulcer with or without LDA
35
Aliment
Pharmacol
Ther
2010;
32:
401-413
LDA Users
LDA Non-Users |
36
Source: DUEXIS Approved Package Insert, April 2011
20.0%
DUEXIS
TID
Ibuprofen
800 mg TID
10.5%
N=190
N=380
p-value = 0.002
8.7%
N=216
N=447
17.6%
DUEXIS
TID
Ibuprofen
800 mg TID
p-value = 0.0004
Statistically significant less dyspepsia vs. ibuprofen
5% vs. 8%
(p-value = 0.009)
All other treatment-emergent GI adverse events were similar
~50 % Reduction in
Gastric or Upper GI Ulcers REDUCE-1, Patients with
Endoscopic Gastric Ulcer (%)
REDUCE-2, Patients with
Endoscopic Upper GI Ulcer (%)
DUEXIS Met Primary Endpoints in Phase 3 Trials |
RELEASE
10pm
2am
6am
10am
Pain &
Stiffness
High
Cytokine
release
RELEASE
High
10pm
2am
6am
10am
RAYOS Synchronizes Pharmaceutical Delivery with
Therapeutic Need
37
Notes: Illustrative only
STANDARD PREDNISONE
-
Current regimen too late
-
Morning administration does not mediate
nocturnal cytokine peak
LODOTRA
-
Optimal nocturnal release regimen
-
Convenient bedtime dosing
-
Reduces morning stiffness and pain
Pain &
Stiffness
Cytokine
release
DOSING
RAYOS is known as LODOTRA outside the United States |
Note:
RAYOS is known as LODOTRA outside the United States
Diff.
(1.7X)
Diff.
(2.5X)
Diff.
(2.8X)
CAPRA-2 -
Pivotal U.S. Phase 3 Study
38
LODOTRA
Placebo
p-value = 0.0002
p-value = 0.0027
p-value = 0.0955
% of Patients with Improvement
Source: Arthritis Rheum 2010 (62 suppl 10:392)
48.5%
22.7%
7.0%
28.6%
9.2%
2.5%
ACR 20
ACR 50
ACR 70
Strong, Significant
Improvement in
ACR 20 and ACR 50
350 Patients
Randomized 2:1
DMARD Use (MTX)
Included in Trial
Safety Comparable
to Placebo
RAYOS -
Significantly Improved ACR 20/50 Response |
RAYOS Delivers
Superior to Immediate-Release Prednisone in Reducing Morning Stiffness
39
CAPRA-1 (Pivotal EU Phase 3 Study)
23% mean relative reduction in morning stiffness after 3 months
Sustained reduction of morning stiffness (~50% reduction)
Reduction in IL-6 levels (~30% after 3 months, ~40% after 12 months)
Relative change from baseline in duration of morning stiffness for the safety set of the open
phase IR PREDNISONE GROUP
SWITCHED TO
LODOTRA
DOUBLE BLIND
PHASE
p-value = 0.045
Mean Immediate Release Prednisone Group
Mean LODOTRA Group
Note:
RAYOS is known as LODOTRA outside the United States
-80
-70
-60
-50
-40
-30
-20
-10
0
10
20
0
1
2
3
4
5
6
7
8
9
10
11
12
13
Study Month
OPEN LABEL PHASE
Source:
The Lancet, 2008 (371:205-14) |
NASDAQ:
HZNP June 2014
Horizon Pharma, Inc.
Filed under Rule 14a-12 of the Securities Exchange Act of 1934
Filing by: Horizon Pharma, Inc.
Subject Company: Horizon Pharma, Inc.
SEC File No. of Horizon Pharma, Inc.: 001-35238
described therein that was made available beginning on June 23, 2014.
The following is a slide presentation relating to the proposed transactions
|