Post on 28-Jun-2020
transcript
AUGUST 2017TICKER: 4167
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DISCLAIMER
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This presentation has been provided by Savior Lifetec Corporation (SLC) for informational purposes only. It is not an offer to buy or sell or a solicitation of an offer to buy or sell any security issued by SLC or other parties.
This presentation may contain forward-looking statements which reflect SLC management’s views, estimates, and currently available information. These statements are SLC management’s opinion and SLC does not provide warranty for the accuracy, reliability, and completeness of the information. Investors should not place undue reliance on the statements, as there are significant risks that could cause actual results or future developments to differ materially from those expressed or implied by forward looking statements. Potential risks include economic conditions, foreign exchange fluctuations, competitive product and pricing pressures, and regulatory developments.
SLC has no obligation to update any forward-looking statement or figures, whether as a result of new information, future events, or otherwise.
關於展旺
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Current Products and Products in Development➢ Penem Injectables➢ Non-Penem Injectables
Company Scale➢ ~500 Employees➢ 2016 Annual Revenues NT$1.5bn
Industry Leadership➢ Top 3 Global Penem Supplier➢ One of Leading Suppliers of Meropenem ➢ Taiwan’s Largest Injectable Supplier by US Sales➢ Amongst the Few Drug Manufacturers Compliant With
US/EU/JP GMP(Fewer Than 10 Out Of 113 Taiwan Manufacturers)
SLC Challenges
How can we change our business model to increase our
profit potential?
Current Products
What is our product development strategy? How can we leverage our current platform and experience? Which products should we target
for development?
New Products
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Stage 4New
Antibiotics
Stage 3 Non-Penems
Stage 2 Penem Vials US Market
Stage 1 Penem APIAbout to take off
Enablers
Reverse Engineering
Quality Infrastructure
Vertical Integration Complex
ChemistryR&D Expertise
Low Cost Structure
Vertical Integration
Regulatory Expertise
時間Current
Savior StrategyStages 1 and 2 have been completed. SLC is making progress in Stages 3 and 4
2016Gretai
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Agenda
Entering the US Market
New Antibiotics
Breaking Even
Ertapenem
Non-Penems
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Entering the US Market
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Source: Internal
The proportion of injection increased significantly
1% 5% 11% 4% 5% 8%
23%
46% 50%
0100200300400500600700800900
1000
1H13 2H13 1H14 2H14 1H15 2H15 1H16 2H16 1H17
FDF Other
(NT$mn)
Double-A StrategySLC is now Taiwan’s largest injectable suppler by US sales
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Breaking Even
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2Q17 2Q16 YoY 1H17 1H16 YoY
Net Sales 444 348 28% 910 641 42%
COGS 282 307 629 620
Gross Profit 162 41 296% 281 21 1238%
Gross Margin 37% 12% 31% 3%
Operating Expense 88 93 (5%) 167 183 (9%)
Operating Income 74 (52) 114 (162)
Operating Margin 17% (15%) 13% (25%)
Non-Op Income (Expense) (28) (9) (55) (16)
Net Income 46 (61) 59 (178)
Net Margin 10% (18%) 6% (28%)
EPS 0.19 (0.25) 0.24 (0.72)
Cash & Cash Equivalents 879 388 127%
1H17 Financials3 consecutive quarters of profit
Turned to profit for three consecutive quarters
3Q16 4Q16 1Q17 2Q17
Net Income(NT$K) (48,883) 19,630 13,130 45,699
EPS (0.20) 0.10 0.05 0.19
Savior’s Last 4 quarters of net income and earnings/share
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FinancialsProfitability began in September 2016
Ertapenem
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The positioning of Ertapenem
Background➢ Broad spectrum antibiotic ➢ Does not include pseudomonal coverage(Nonpseudomonal) ➢ Different from other Penem products➢ Used primarily for Community Acquired G- infections
(coverage of over 98%)➢ 1x a day, which reduces hospital labor costs and patient complications
Increasing antibiotic resistance➢ Cephalosporin and Quinolone resistance becoming severe in regards to
G- infections (coverage of less than 80%)➢ More than 20% treatment failure in urethra, kidney, abdominal and
other➢ Urgent unmet medical needs
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Ertapenem Clinical UsageGram Positive Cocci Gram Negative Bacilli
AnaerobesMRSA MSSA Streptococci
E.Coli,KlebsiellaPseudomonas ESCAPPM*
Proteus
Amoxicillin(Penicillin)
Amoxicillin-Clavulanate(Penicillin + BLI)
Amoxicillin-Clavulanate(Penicillin + BLI)
Piperacillin-Tazobactam(Penicillin + BLI)
Piperacillin-Tazobactam(Penicillin + BLI)
Moxifloxacin(Fluoroquinolone)
Moxifloxacin(Fluoroquinolone)
Ceftriaxone(Cephalosporin)
Cefepime(Cephalosporin)
Meropenem(Carbapenem)
Imipenem-Cilastatin(Carbapenem)
Ertapenem(Carbapenem)
Ertapenem(Carbapenem)
Daptomycin(Lipopeptide)
Ertapenem is generally prescribed to treat nonpseudom-onalG- infections. Ertapenem is administered once a day, which lowers hospital labor costs and patient complications
Note: ESCAPPM organisms are Enterobacter spp.,Serratia spp.,Citrobacter freundii.,Aeromonasspp.,Proteus spp.,Providencia spp.,Morganella morganii
Source: Wellington ICU Drug Manual
Determinants of Ertapenem Launch Timing
Ertapenem PIV ANDA DA
► July 2014 ANDA filing
► October 2016 US FDA EIR
► Expected to complete the contracting in the second half
Litigation
► US District Court has ruled the‘323 Orange Book patent as valid, and the ‘150 patent as invalid
► Merck is appealing.
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US$/1g
Ertapenem price trend
The Price of originate product is still increasing in US
Ertapenem’s Primary Market is the US
According to Merck’s report2016 Erta US sales : US $ 329mn
Source: CMS
Source: Internal,IMS HealthAssumptions: Intended to provide a basic sensitivity analysis and do not represent the company’s formal guidance
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Generics2
Generics1
Generic
US Market
Brand NSP (US$/Unit) 83
Brand Volume (Vials,mn) 4.0 4.0 4.0 4.0
Generic Penetration Assumption 85% 75% 40%
Generic Volume (Vials,mn) 3.4 3.0 1.6
Marketer Economics
Generic Market Share Assumption 30% 45% 100%
Volume (Vials,mn) 1.0 1.4 1.6
NSP (US$/Unit) Assumption 42 54 62
Sales (US$mn) 42 76 99
Ertapenem US Market Sensitivity AnalysisOrder Of ANDA Filing:Sandoz (Withdrawal), Hospira, SLC
New Antibiotics
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Source: US FDA
In The Past Few Decades, Antibiotic Approvals Have DeclinedThis is due to technological, financial, and regulatory hurdles
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1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
Number of Approvals
From 2002-13, the US FDA had only approved 7 new antibiotics
After QIDP, from 2014-2017, there have been 8 approvals
Source: US Government Accountability Office Report Jan-2017
QIDP drugs receive an additional 5 years exclusivity. For instance, if an NCE was entitled to 5 years of exclusivity under Hatch Waxman, if the drug received QIDP status, it would receive 10 years of exclusivity.
Exclusivity
Priority ReviewThe FDA would decrease the target review time from 10 months to 6 months.
The FDA would increase communications, allow partial reviews. Fast Track
QIDP Advantages
THE 8 APPROVED QIDP ANTIBIOTICS
QUALIFIED INFECTIOUS DISEASE STATUS>100 new antibiotic development case obtained QIDP qualification(Admission rate of 90%)
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ChemicalTrade Name
FormFDA
Approval Date
Sponsor OriginatorIMS Avg
Price (US$/unit)
Est. Peak Market(US$mn)
Dalbavancin Dalvance Vials 2014/5/23 Allergan Durata 1,133 215
Tedizolid SivextroTabletVials
2014/6/20 Merck Cubist 265 615
Oritavancin Orbactiv Vials 2014/8/6
The Medicines Company
Eli Lilly 815 126
Ceftolozane-tazobactam
Zerbaxa Vials 2014/12/19 Merck Cubist 88 1,387
Ceftazidime-avibactam
Avycaz Vials 2015/2/25 Allergan Forest Labs 278 375
Isavuconazole CresembaTabletVials
2015/3/6 Basilea Basilea 77 NA
Bezlotoxumab Zinplava Vials 2016/10/21 Merck Medarex NA NA
Delafoxacin BaxdelaTabletVials
2017/6/19 Melinta Wakunaga NA NA
Source: FDA, US Government Accountability Office Report Jan-2017, Springer, IMS, Bloomberg, Various
THE 8 APPROVED QIDP ANTIBIOTICSAlmost all QIDP drugs are acquired or authorized by large pharmaceutical companies
The US Congress is heavily subsidized to encourage the development of new antibiotics
(BARDA>$550mn/5yrs Non-Dilutive Funding).
QIDP makes it easier for these companies to fundraise
80% of antibiotic developers are small developers
Small developers are more likely to need CDMO partners
SLC plays key role in the new penem developement
QIDP status is especially useful for small developers
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New Drug Development Partnership Will Drive Revenue GrowthSavior is well positioned to collaborate with antibiotic developers
Savior and Global pharmaceutical companies signed a new drug development agreement on 2017/07/03
►The new drug development agreement Milestones totaling US$6mn, payment due after specified milestone events
Non-Penems
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Source: Symphony Health
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Generic Name Type Indications2016
US WAC (US$mn)
SLC-019 Small MoleculeNiche Injectable
ANDA
Muscle Relaxant 160
SLC-025 Hypotension 366
SLC-024 Nausea 357
SLC-006 Sustained Depot Complex InjectableWith IP Protection
Prostate CancerEndometriosis
2,774
SLC-021 Schizoaffective 1,530
SLC-010 Type II diabetes 779
Non Penem Injectable ProjectsNon penems are the mid/long-term revenue drivers, revenue contributions expected in 2020
►API Tech Platforms►Biological recombinant peptide
expression►Solid phase peptide synthesis (SPPS)►Bio-chemical conjugation technology
►Sustained Release Formulation Tech Platforms►Microcapsule continuous process
manufacturing technology►Nanocrystal Formulation Tech Platforms
►Nanocrystal manufacturing technology
Key Steps ► January 2018 API and filling lines construction
completion►Apply for TFDA inspections, comply with TFDA
GMP►Complete high-speed filling lines►Complete US FDA GMP
Tech Platform
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Chunan-2 Site
Chunan-2 Site Map
Non-Penem Site PlanningPenem facilities need to be dedicated, Non-penem facilities will be at a different site
Q&A