26
OCTOBER 2019 TICKER: 4167 1

OCTOBER 2019 TICKER: 4167 - Savior Lifetec

  • Upload
    others

  • View
    7

  • Download
    0

Embed Size (px)

Citation preview

Page 1: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

OCTOBER 2019TICKER: 4167

1

Page 2: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

DISCLAIMER

2

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.

Page 3: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

About SLC

3

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

Page 4: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

SLC’s Vision

4

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are increasing in the US market.◆ Existing competitors have withdrawn from the market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

Page 5: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

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

5

= API

= InjectableErtapenem

UK MA approved

Signed a CDMO contract for new

penem

= CDMO

Signed a CDMOcontract for new

penem

ErtapenemANDA approved

Page 6: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

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

6

Page 7: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Agenda

Operation Overview

New Antibiotic Development

Meropenem

Ertapenem

7

Page 8: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Operation Overview

8

Page 9: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

9

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

Page 10: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

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

10

Page 11: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Meropenem

11

Page 12: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Meropenem Global Market Continues to GrowCAGR= 5%

12

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)

Page 13: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

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.

Page 14: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Ertapenem

14

Page 15: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Ertapenem Global Market

• SLC obtained Market Authorizations in the US, UK, Spain, Italy

and planned to obtain MAs in other major market globally.

15

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)

Page 16: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

New Antibiotic Development

SLC joins the battle against drug-resistant bacteria in the world

16

Page 17: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

17

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.

Page 18: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

18

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

Page 19: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

19

Source: US FDA

In The Past Decades, New Antibiotic Approvals DeclinedThis is due to technological, financial, and regulatory hurdles

0

1

2

3

4

5

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.

Page 20: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

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

20

Page 21: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

21

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

Page 22: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

22

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

Page 23: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

23

◆ 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

Page 24: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

24

◆ 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

Page 25: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

25

◆ 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

Page 26: OCTOBER 2019 TICKER: 4167 - Savior Lifetec

Q&A