NasdaqGS: SNTS
Safe Harbor
This presentation may include forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management.
The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or projected financial outlook will be achieved. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’ ability to generate sales of its commercial products; risks related to Santarus’ product
development programs and regulatory submissions; Santarus’ ability to maintain patent protection and data exclusivity for its products and product candidates; other difficulties or delays in the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; and other risks detailed in Santarus’ public filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Santarus undertakes no obligation to revise or update this presentation. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus®, Zegerid®, Zegerid OTC®, Fenoglide® and Uceris® are registered trademarks of Santarus, Inc. MMX® is a trademark of Cosmo Technologies
Limited. Glumetza® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the U.S. to Depomed, Inc. Ruconest® is a trademark of
Pharming Group NV. Cycloset® is a trademark of VeroScience LLC. All other trademarks appearing in this presentation are the property of their respective
owners.
Full prescribing and safety information for Santarus’ products is available at www.santarus.com.
Investment Highlights
•
Profitable specialty biopharmaceutical company with a focus on
proprietary products
– Attractive mix of commercial and development opportunities
– Recent launch of Uceris® (budesonide) for induction of remission in
patients with active, mild to moderate ulcerative colitis
– Appellate court decision upheld certain Zegerid® IP
– Generic ceased distribution, but has continued to challenge at lower court
– New Cycloset® patent issued on April 30, 2013 with potential to
extend runway
•
Record revenues of $218 million in 2012; 54% projected
revenue growth in 2013 with significant growth in net income*
•
Late-stage pipeline provides potential opportunity for high-value,
sustainable, long-term growth
Mix of Commercial & Development Opportunities
4
Focus on proprietary products for physician specialists
Balancing investments in R&D and SG&A to achieve meaningful, sustainable growth in revenues and profits
Sales potential of ~$650M - $750M* Gastroenterology • Uceris® • Zegerid® Type 2 diabetes • Glumetza® • Cycloset® Cholesterol lowering • Fenoglide® Commercial Portfolio
Sales potential of ~$200M* (initial indications)
Late-stage
• Ruconest® (recombinant human C1 esterase inhibitor) – Positive Phase III data in acute HAE • Rifamycin SV MMX®– Positive Phase III data
in travelers' diarrhea
Development Pipeline
Early-stage
SAN-300 (anti-VLA-1 antibody) – Phase I completed
Specialty Focus - Leverage Commercial Investment
N ear term 2013 M ed iu m ter m Long ter mEndocrinologists & Selected PCPs (150 reps)
Glumetza®, Cycloset®, Fenoglide®
Rheumatologists (30 reps) SAN-300 Gastroenterologists (85 reps) Uceris® , Zegerid® Rifamycin SV MMX, SAN-300 Allergists/ Immunologists (25 reps) Ruconest®, SAN-300
Financial Strategy – Increase Shareholder Value
6
Leverage sales organization • Increase sales per rep
• Increase revenue
Decrease SG&A as % of revenue Maintain R&D as % of revenue
• Increase profits & cash flow • Invest for future growth
Growth Strategies
•
Maximize value of existing portfolio through additional
formulations or indications
•
Continue to seek new marketed or late-stage development
products through license or acquisition, including company
acquisitions
– Gastroenterology
– Endocrinology
– Other selected specialties
•
Plan to add new senior executive position to focus on strategic
planning and acquisitions
Sales Force Product Mix
8235 Sales Reps
Primary Care Physicians Endocrinologists Glumetza® Glumetza Cycloset® Cycloset Fenoglide®/ Zegerid* Fenoglide Gastroenterologists Uceris® Zegerid®Uceris
®• FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate ulcerative colitis
• Commercial launch commenced mid-February, 2013 • $6.6 million net sales in 1Q 2013
• Ulcerative colitis, an inflammatory bowel disease (IBD), affects approximately 700,000 patients in U.S.
• Limited therapeutic options for mild to moderate ulcerative colitis • CONTRIBUTE clinical study with Uceris in combination with 5-ASAs
for active, mild to moderate ulcerative colitis – expect to complete enrollment mid-2013
• Four U.S. patents expire in 2020
Locally acting steroid with MMX® colonic delivery
Estimated sales potential of ~$300 million*
Established Therapies for Mild to Moderate Ulcerative Colitis
10
Step-up according to severity at presentation or failure at prior step
5-ASA Systemic Corticosteroids Anti-TNFα Disease severity at presentation 5-ASA / Thiopurine 5-ASA Anti-TNFα Induction Maintenance Cyclosporine Thiopurine Severe Moderate Mild
Kornbluth and Sacher, Am J Gastroenterol 2010; 105: 501-523
Severe
Moderate
Mild
Selected IBD Products – U.S.
TRx and IMS Sales Trends – March 2013
* Generic version of Entocort EC launched in June 2011.
$83M 25% $154M 16% $306M 6% $461M 13% $408M -12% $770M -2% $2,186M 2% Apriso Canasa Pentasa Entocort EC/Gen* Lialda Asacol/HD Total
LTM Sales, Y/Y Growth
0.2M 0% 0.3M 21% 0.5M 8% 0.5M -4% 0.7M 7% 1.6M -3% 3.7M 2% Canasa Apriso Entocort EC/Gen* Pentasa Lialda Asacol/HD Total LTM TRx, Y/Y Growth
Uceris
®Weekly Prescription and Prescriber Trends
14
Source: IMS Health, Weekly NPA
- 28 130 197 357 393 492 579 581 719 690 764 855 868 931 - 28 129 197 356 383 459 512 503 571 546 560 599 635 640 24 96 157 270 285 347 385 377 429 427 425 463 489 - 100 200 300 400 500 600 700 800 900 1,000
Uceris Prescribers and New/Total Prescriptions
TRx NRx
Zegerid
®*Source: IMS Healthcare NPA
• Par Pharmaceutical ceased generic distribution after
appellate court ruling in favor of Santarus in Sept 2012 • Jury trial to determine
damages scheduled for November 2014
• Patents expire in July 2016 • Net sales of $24.6 million in
Zegerid brand/AG in 1Q 2013
Indicated for the treatment of certain upper GI disorders, including GERD – Re-launched in February 2013
* Please see www.zegerid.com for full prescribing and safety information
- 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000 20,000 Mar -10 May -10 J ul -10 S ep -10 Nov -10 J an -11 Mar -11 May -11 J ul -11 S ep -11 Nov -11 J an -12 Mar -12 May -12 J ul -12 S ep -12 No v -12 J an -13 Mar -13 May -13 T Rx
Zegerid Molecule Prescription Trend 4-Week Moving Average
Glumetza
®*16
* Please see www.Glumetzaxr.com for full prescribing and safety information including a Black Box warning.
Source: IMS Health, Weekly NPA
• Once-daily, extended-release oral tablet
• Controlled delivery may improve GI tolerability and allow more patients to reach A1C goal
• 18% TRx growth in 1Q 2013 vs. prior year period
• $41.5 million net sales in 1Q 2013
Differentiated product with features well received by physicians
- 500 1,000 1,500 2,000 2,500 3,000 3,500 - 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 NRx T Rx
Glumetza Prescription Trends 4-Week Moving Average
Glumetza
®Market Potential
Glumetza®
Santarus called-on physicians write approximately 8.3 million generic metformin prescriptions per year
8.3M
Generic Metformin 0.3M
Cycloset
®*18
First and only centrally acting, oral type 2 diabetes product
• Unique formulation of bromocriptine
• Consistent A1C control
• Demonstrated cardiovascular safety profile with 52% relative risk reduction in MACE** in pivotal clinical study
• 44% TRx growth in 1Q 2013 vs. prior year period
• 1Q 2013 sales of $3.9 million
* Please see www.Cycloset.com for full prescribing and safety information
Source: IMS Health, Weekly NPA
Prescriptions normalized to 120 pills per RX
** MACE = Non-fatal MI, Stroke or CV death
1,639 684 - 200 400 600 800 1,000 1,200 1,400 1,600 1,800 2,000 D ec -10 F eb -11 A pr -11 May -11 J ul -11 S ep -11 N ov -11 J an -12 Mar -12 A pr -12 J un -12 A ug -12 Oct -12 D ec -12 J an -13 Mar -13 May -13 P res cr ipt ion s
Cycloset Prescription Trends 4 Week Moving Average Normalized TRx
0 100 200 300 400 500 600 700 800 P res cr ipt ion s
Fenoglide Prescription Trends 4 Week Moving Average
TRx NRx
Fenoglide
®*• High cholesterol is a co-morbid condition
frequently associated with type 2 diabetes
• Strong overlap with current called-on physicians
• Net sales of $1.9 million reported by Santarus in 1Q 2013
Indicated for the treatment of high cholesterol
* Please see www.fenoglide.com for full prescribing and safety information
Source: IMS Health, Weekly NPA
Santarus Development Pipeline
Product /Candidate Phase I Phase II Phase III
Uceris® (add-on to 5-ASA)
Uceris (pediatric)
Ruconest® (acute treatment - HAE)
Ruconest (prophylaxis - HAE) Ruconest (acute pancreatitis) Rifamycin SV MMX® (TD)
SAN-300 (RA) SAN-300 (IBD)
CONTRIBUTE study
BLA submitted April 2013
SPA to be discussed with FDA
Phase II timing TBD
Anticipate pre-IND meeting with FDA Anticipate pre-IND meeting with FDA
One Phase III study completed *
*Santarus will share data from a second Phase III study in progress by Dr. Falk Pharma for inclusion in regulatory submissions, if positive.
• Ruconest met the primary endpoint in recently completed Phase III study conducted under Special Protocol Assessment
• Two prior placebo-controlled studies completed with statistically significant results
• Submitted Biologics License Application (BLA) to FDA in April 2013 • Plan to explore clinical and regulatory strategies for HAE
prophylaxis and acute pancreatitis
• Two U.S. patents expire in 2022 and 2024
• As a biologic product, Ruconest expected to have 12 years of data exclusivity upon FDA approval
Investigational drug with orphan drug designation in U.S. for treatment of acute attacks of hereditary angioedema (HAE)*
Ruconest
®(recombinant human C1 esterase inhibitor)
Ruconest
®- Positive Phase III Data for 50 U/kg
Study 1310 Results
Intent-to-Treat Population (N=75) Ruconest 50 U/kg
(n = 44)
Saline
(n = 31) P-value
Median time to the beginning of symptom relief (Primary Endpoint)
(Based on Treatment Effect Questionnaire)
90 minutes
152
minutes 0.031 Safety Population (N=74) Ruconest 50 U/kg*
(n = 56)
Saline
(n = 18)
Patients with ≥1 treatment emergent AE within 72 hrs
of completion of infusion of study drug 7% 22%
* Patients who received saline solution followed by Ruconest as rescue medication are summarized in the Ruconest group.
• Ruconest was generally well tolerated in the study
• No thromboembolic events, anaphylaxis or neutralizing antibodies to C1 inhibitor were observed in any patient
• Conducted under an FDA Special Protocol Assessment
U.S. HAE Treatments - Evolving to Acute Therapies
Cinryze®
10-15% of patients
• Most severe cases • Very frequent attacks • History of
life-threatening or intense pain
• Significant impact on QOL
Berinert®, Kalbitor®, Firazyr®
60-70% of patients
• Mild/moderate cases • More frequent attacks • Peripheral locations • Generally no history of life
threatening attacks Androgens** 20-25% of patients • Milder cases • Infrequent attacks • Generally stable/well controlled • Cost/coverage issues • Skews male
* Based on qualitative market research conducted by Santarus with physicians treating HAE patients and managed care representatives (n=18). Patient preference will also influence treatment choice.
** Anabolic steroids
Physicians’ views of future distribution of treatments for HAE patients with introduction of additional acute therapies*
Traditional
Rifamycin SV MMX
®• Clinical activity in infectious diarrhea appears comparable to Xifaxan® (rifaximin)
• Positive top-line results in multicenter, randomized, double-blind Phase III clinical study for treatment of patients (n = 264) with travelers’ diarrhea
– Median TLUS was 46.0 hours for rifamycin SV MMX and 68.0 hours for placebo, p= 0.0008 (ITT population)
– Rifamycin SV MMX was generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo
• Dr. Falk Pharma (Germany) conducting second Phase III clinical study in travelers’ diarrhea
– Non-inferiority study vs. ciprofloxacin
– Protocol amendment to add ~250 patients under review by Indian regulatory authorities
• U.S. patents expire in 2020 and 2025
Investigational broad spectrum, non-systemic antibiotic oral tablet formulated with MMX colonic delivery technology
SAN-300 (anti-VLA-1 antibody)
• Humanized antibody created by Biogen Idec
• Efficacy in multiple preclinical models of inflammation, including
inflammatory bowel disease, rheumatoid arthritis, psoriasis, asthma and organ transplant
• Phase I clinical study (intravenous and subcutaneous formulations) completed
• Safety, PK and PD data from Phase I study with IV and SC formulations support going into Phase II
• Phase IIa clinical study in RA planned to begin 4Q 2013
• Covered by seven U.S. patents expiring in 2020 and 2022, including a composition of matter patent expiring in 2022
– As a biologic product, SAN-300 expected to have 12 years of data exclusivity upon FDA approval
Investigational novel biologic with potentially broad clinical applications in autoimmune and inflammatory diseases
2013 2012 2012 Product sales, net
Glumetza® $ 41.5 $ 31.2 $ 145.0
Zegerid® 24.6 8.5 48.0
Uceris® 6.6 - -
Cycloset® 3.9 3.6 14.5
Fenoglide® 1.9 1.8 7.1
Total product sales, net 78.5 45.1 214.6
Other revenue 0.9 0.8 3.4
Total revenues $ 79.4 $ 45.9 $ 218.0
1Q 2013 and Full Year 2012 Total Revenues (Unaudited)
26
Three Months Ended March 31,
Three Months Ended March 31,
Cash, cash equivalents & short-term investments of $97.6 million at March 31, 2013
1Q 2013 and Full Year 2012 Financial Results (Unaudited)
Year Ended Dec 31,
($ Millions)
Except per share amounts 2013 2012 2012
Total revenues $ 79.4 $ 45.9 $ 218.0 Total costs & expenses $ 59.6 $ 44.8 $ 197.8 Net income $ 18.7 $ 0.6 $ 18.6 EPS, diluted $ 0.25 $ 0.01 $ 0.27
Non-GAAP adjusted earnings*
$ 23.9 $ 7.8 $ 36.9
* Adjusted earnings is a non-GAAP financial measure. A reconciliation of adjusted earnings to GAAP net income can be found at the end of this presentation.
($18) $5 $19 $61 ($16) $8 $37 $86 ($20) $0 $20 $40 $60 $80 $100 2010 2011 2012 2013E Net income Adjusted Earnings*
$ Millions
2010 – 2012 Financial Results and 2013 Estimates
28
**Midpoint of Santarus internal 2013 financial outlook provided on May 6, 2013
*Adjusted earnings is a non-GAAP financial measure. A reconciliation of adjusted earnings to GAAP net income can be found at the end of this presentation.
$125 $119 $218 $335 $0 $50 $100 $150 $200 $250 $300 $350 $400 2010 2011 2012 2013E Revenues ** $ Millions ** **
2013 Potential Milestones
FDA approval for Uceris
® 1/14/13
Uceris commercial launch 2/14/13
Submit BLA for Ruconest® in HAE 4/16/13• Complete enrollment in Uceris Phase IIIb study Mid-2013 • Initiate SAN-300 Phase IIa study in RA patients 4Q 2013 • Initiate proof-of-concept study with Ruconest in
acute pancreatitis Late-2013
• Grow prescriptions and revenues for marketed
products 2013
Investment Highlights
•
Profitable specialty biopharmaceutical company with a focus on
proprietary products
– Attractive mix of commercial and development opportunities
– Recent launch of Uceris® (budesonide) for induction of remission in
patients with active, mild to moderate ulcerative colitis
– Appellate court decision upheld certain Zegerid® IP
– Generic ceased distribution, but has continued to challenge at lower court
– New Cycloset® patent issued on April 30, 2013 with potential to
extend runway
•
Record revenues of $218 million in 2012; 54% projected
revenue growth in 2013 with significant growth in net income*
•
Late-stage pipeline provides potential opportunity for high-value,
sustainable, long-term growth
30
Uceris
®Important Safety Information
CONTRAINDICATIONS
Uceris is contraindicated in patients with known hypersensitivity to budesonide or any of the ingredients of Uceris.
WARNINGS AND PRECAUTIONS
Hypercorticism and adrenal suppression. Risk of impaired adrenal function when transferring from oral steroids with high systemic effects. Potential worsening of infections (eg, existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Increased systemic glucocorticoid
susceptibility: Reduced liver function affects the elimination of glucocorticosteroids. Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or
cataracts, or with a family history of diabetes or glaucoma, or with any other condition where
glucocorticosteroids may have unwanted effects. Hepatic impairment: Monitor patients for signs and/or symptoms of hypercorticism. The most common adverse reactions (incidence ≥2%) with Uceris are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.
This Important Safety Information does not include all of the information needed to use Uceris safely and effectively. See Full Prescribing Information for additional information.
Reconciliation of GAAP Net Income to Non-GAAP Adjusted
Earnings (Unaudited) – 1Q 2013 and 1Q 2012
($ Millions) Three Months Ended
March 31,
2013 2012
GAAP net income $ 18.7 $ 0.6
Interest (income) expense 0.1 0.1
Income tax expense 1.1 0.3
Depreciation and amortization 1.6 1.5
Stock-based compensation 2.2 1.4
Stock issuance for regulatory milestone - 3.7
Loss on contingent consideration 0.2 0.2
Non-GAAP adjusted earnings $ 23.9 $ 7.8
Adjusted earnings, is a non-GAAP financial measure. Santarus believes that the presentation of this non-GAAP financial measure provides useful supplementary information to and facilitates additional analysis by investors. The company uses this non-GAAP financial measure in connection with its own budgeting and planning. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.
Reconciliation of GAAP Net Income to Non-GAAP Adjusted
Earnings in 2010-2012 Financial Results (Unaudited)
Years Ended December 31,
($ Millions) 2012 2011 2010
GAAP net income (loss) $ 18.6 $ 4.7 $ (18.5)
Interest (income) expense 0.3 0.4 0.4
Income tax expense 1.3 0.3 0.1
Depreciation and amortization 6.1 3.1 2.0
Stock-based compensation 6.7 5.4 5.0
Stock issuances under license agreements 3.7 - 2.9
Restructuring charges - - 7.1
Loss on contingent consideration 0.2 - 0.1
Non-GAAP adjusted earnings $ 36.9 $ 13.9 $ (0.9)
Reconciliation of GAAP Net Income to Non-GAAP Adjusted
Earnings Guidance for the Year Ending December 31, 2013
GAAP net income $57 - $64
Interest (income) expense 0
Income tax expense 4 - 5
Depreciation and amortization 7 - 8
Stock-based compensation 13 - 14
Non-GAAP adjusted earnings $81 - $91
* Santarus internal 2013 financial outlook provided on May 6, 2013
2013 Financial Outlook for Net Income and Non-GAAP Adjusted Earnings*