october 2019 ticker: 4167 - savior lifetec
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OCTOBER 2019TICKER: 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.
About SLC
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Product and Service Scope➢ Penem Injectables➢ Non-Penem Injectables➢ CDMO service
Industry Leadership➢ Top 3 Penem Manufacturers in the world➢ Attainable global market size (Meropenem and
Ertapenem) is around US$1.8 billion➢ Taiwan’s Largest Injectable Supplier in terms of Sales in
the US market➢ Obtained Ertapenem ANDA and MA in major EU
countries ➢ Facilities Compliant With US/EU/JP GMP regulations
SLC’s Vision
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Becoming a leading generic company in Taiwan in terms of export value to the US market◆ Meropenem and Ertapenem injection market shares
are increasing in the US market.◆ Existing competitors have withdrawn from the market
due to inability to comply with more stringent global sterile GMP regulations.
Becoming a strategic partner for developing novel antibiotic drugs in the world
Becoming an global expert in the field of sterile API and freeze-dried injectable product
Major MilestonesSLC obtained Ertapenem ANDA approval this year
API Factory passed
US FDA GMP inspection
Apply for ANDAof Meropenem
Injectable Plant completion
Injectable Plant passed
US FDA GMP inspection
MeropenemANDA approved
Meropenem&Ertapenem factory in
Tainan completion
Apply for P-IV
ANDA of Ertapenem
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= API
= InjectableErtapenem
UK MA approved
Signed a CDMO contract for new
penem
= CDMO
Signed a CDMOcontract for new
penem
ErtapenemANDA approved
Stage 4New
Antibiotics
Stage 3 Non-Penems
Stage 2 Penem Vials US Market
Stage 1 Penem APIAbout to take off
Enablers
Reverse Engineering
Quality Infrastructure
Aseptic Process
RD expertise RD expertiseLow Cost Structure
Vertical Integration
Regulatory Expertise
時間Current
SLC’s Strategy RoadmapStage 1 and 2 have been completed. SLC is making progress in Stage 3 and 4
2016Gretai
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Agenda
Operation Overview
New Antibiotic Development
Meropenem
Ertapenem
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Operation Overview
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3Q19 Income Statement
($mn) 3Q19 2Q19 3Q18
Net Sales 341 304 260
COGS 248 249 305
Gross Profit 93 55 (45)
Gross Margin 27% 18% (17%)
Operating Expense 83 80 48
Operating Income 10 (25) (93)
Operating Margin 3% (8%) (35%)
Non-Op Income (Expense) (8) (10) (4)
Net Income 2 (35) (97)
Net Margin 0% (11%) (37%)
EPS 0.01 (0.14) (0.39)
Cash & Cash Equivalents 623 436 423
Highlights in 2019~2020
• US Ertapenem market share expansion
• US Meropenem market share expansion
• CDMO service for process validation of new antibiotics
• The completion of an oral tablet manufacturing line
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Meropenem
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Meropenem Global Market Continues to GrowCAGR= 5%
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114 148 126 122 111
374 337 314 322 379
757 796 856 927 986
0
500
1000
1500
2000
2014 2015 2016 2017 2018
Global Sales
Unuted States EURO Other
(US$mn)
The US Market TrendHalf of US suppliers have a shortage of supply
13Source: American Society of Health-System Pharmacists
52%
35%
48%
43%
7%
11%
There are 3 / 6 meropenem injection products being affected.
According to a report by ASHP on 2019/10/29 , there is a supply shortage of Meropenem Injection in the US market.
Ertapenem
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Ertapenem Global Market
• SLC obtained Market Authorizations in the US, UK, Spain, Italy
and planned to obtain MAs in other major market globally.
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Source: IMS
279 333 350 369 369
67 57 57 59 67 97
109 101 108 124
0
200
400
600
800
2014 2015 2016 2017 2018
Global Sales
Unuted States EURO Other
(US$mn)
New Antibiotic Development
SLC joins the battle against drug-resistant bacteria in the world
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Antibiotic Resistance Continues to Trend Higher
Source: Center for Disease Dynamics, Economics Policy (CDDEP) & The Surveillance Network (TSN); Gonzalo Bearman MD,MPH; Centers for Disease Control (CDC)(1) FDA warns against the use of quinolones for uUTI due to safety concerns
◼ Quinolone and Cephalosporin Efficacy Steadily Eroding.
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Quinolone Resistance Driving Need For New Therapies
>25% resistance rate in most populous regions of the U.S.
2014, CDC, inpatient E. coli Quinolone resistance, by state2017 outpatient Enterobacteriaceae Quinolone Resistance, by zip code
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Source: US FDA
In The Past Decades, New Antibiotic Approvals DeclinedThis is due to technological, financial, and regulatory hurdles
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1
2
3
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1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018
Number of Approvals
During 2002-2013, the US FDA approved only 7 new antibiotics
After the US congress passed the GAIN act, there have been 12 QIDP drugs approved by FDA during 2014-2019.
Source: US Government Accountability Office Report Jan-2017
QIDP drugs will enjoy an additional 5-year market exclusivity if approved by FDA. (For instance, if a new chemical entity(NCE) was entitled to 5-year market exclusivity and also obtained QIDP designation, the total market exclusivity will be 10 years.)
Exclusivity
Priority ReviewThe FDA would decrease the target review time from 10 months to 6 months.
The FDA will have intensive communication with the drug developer and conduct a rolling review process. Fast Track
Three main incentives for QIDP drug developers
FDA have approved 12 new antibiotics with QIDP designation.
The Progress Of QIDP Drug Development>100 new antibiotic development obtained QIDP designation
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Potential for Oral Specialty Antibiotic
◼ Advantages of Oral Specialty Antibiotic
Community patients to avoid hospitalization
Hospitalized patients to shorten length of hospital stay
US Market Opportunity in UTI (urinary tract infection)
Patients SegmentPatient
populationFluoroquinolone
Resistant ratioMarket Size
~10M ~12% ~$ 2 Billion
~2M ~35% ~$ 2 Billion
Community UTI Fluoroquinolone
Resistant
Hospitial UTI Fluoroquinolone
Resistant
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Why is Oral Specialty Antibiotic Different
Challenges Faced by Recent Antibiotic Launches Oral Special Antibiotic Differentiation
IV Only Antibiotics Limited hospital market with inexpensive generic competitors
Oral Antibiotic • Access to very large community market with Oral Specialty
Antibiotic • Opportunity for step-down to Oral Specialty Antibiotic to
reduce hospital length-of-stay and/or confidently transition home
Hospital Focused • Long & challenging formulary process • Reimbursed within existing DRG
Community Focused, plus Hospital Step-Down • Favorable reimbursement with Oral Specialty Antibiotic • Reimbursement for Oral Specialty Antibiotic not part of the
DRG
Single Indication Products focus on a single indication, often with niche markets
Multiple Indications at Launch Oral Specialty Antibiotic to launch with several indications.
Unproven and Challenging Antibiotic Classes New antibiotic classes or antibiotic classes with known safety challenges
Proven & Trusted Antibiotic Class • Safe with efficacy and trust of a Antibiotic • Potential to be the first oral Specialty Antibiotic available in the
U.S.
Fierce Competition Multiple branded products fighting for share in small hospital IV markets
Dominant Share of Voice • First new branded oral for UTIs in over 20 years • Potential to be only product promoted for UTI for a few years
post approval
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◆ It has injection and oral dosage forms. Injection can control bacterial infections in hospital. Oral dosage form can reduce hospital stay because patients can be still be well treated after being discharged from the hospital.
◆ Oral dosage form of drug substance is derived from Peron antibiotics. Pro-drug design has been successfully applied in AIDS and hepatitis C oral antiviral therapy in the past 10 years.
◆ Because SLC is the top 3 Global Penem Supplier, SLC is fit to be these new penem developers’ strategic partner.
New Penem
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◆ SLC-017: Treatment of urinary tract infections.
◆ Global Phase III clinical trial is ongoing.
◆ SLC supplies API and FDF.◆ Completed the setup of a API facility.◆ Process validation and commercial production is
discussion.
CDMO is Next Growth Driver
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◆ SLC-029: Treatment of urinary tract infections.
◆ Global Phase III clinical is ongoing.
◆ SLC supplies FDF.◆ Oral tablet production and packaging lines are
under construction.◆ This new manufacturing line’s registration batch
will support customer’s NDA filing.
CDMO is Next Growth Driver
Q&A