Goldman Sachs Healthcare Conference

Goldman Sachs
Annual Global Healthcare
Conference
June 8, 2016
Rancho Palos Verdes, CA
Scott Johnson, MD
Chief Medical Advisor
Legal notices
Forward looking statements
Statements contained in this presentation
about The Medicines Company (the
“Company”), the Company’s products and
product candidates, clinical trial results,
regulatory submissions, product or indication
launches, the Company’s future financial and
operating results, and future opportunities for
the Company, that are not purely historical, and
all other statements that are not purely
historical, may be deemed to be forward-looking
statements for purposes of the safe harbor
provisions under The Private Securities
Litigation Reform Act of 1995. Without limiting
the foregoing, the words “believes,"
“anticipates," “plans," “expects," “intends,"
“potential," “estimates," “outlook” and similar
expressions are intended to identify forwardlooking statements. There are a number of
important factors that could cause actual results
or events to differ materially from those
indicated by such forward looking statements,
including: the extent of the commercial success
of our products; the Company's ability to
develop its global operations and penetrate
foreign markets; whether the Company’s patent
and other litigation is resolved in a timely and
satisfactory manner; whether the results of
preclinical studies or early clinical trials will be
indicative of the results of later clinical trials;
whether the Company’s product candidates will
advance in the clinical trials process on a timely
basis or at all; whether the clinical trial results will
warrant submission of applications for
regulatory approval; whether the Company will
make regulatory submissions for product
candidates on a timely basis or at all; whether
the Company’s product candidates will receive
approvals from regulatory agencies on a timely
basis or at all; whether the Company’s ongoing
and planned commercial launches will be
successful; whether physicians, patients and
other key decision makers will accept clinical
trial results, whether we can successfully enter
into strategic partnerships; whether the
Company can protect its intellectual property;
the ability of the Company and Chiesi to
consummate the cardiovascular product
transaction; satisfaction of the conditions to the
completion of the cardiovascular product
transaction, including, without limitation, the
expiration or termination of the applicable
waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as
amended; the commercial success of such
cardiovascular products and the achievement of
future milestone payments; and such other
factors as are set forth in the risk factors
detailed from time to time in the Company’s
periodic reports filed with the Securities and
Exchange Commission (“SEC”) including,
without limitation, the risk factors detailed in the
Company’s Form 10-Q filed with the SEC on
May 9, 2016, which are incorporated herein by
reference. The Company specifically disclaims
any obligation to update these forward-looking
statements. You are cautioned not to place
undue reliance on these forward-looking
statements, which speak only as of the date of
this presentation. All forward-looking
statements are qualified in their entirety by this
cautionary statement.
Overview
Focus on value creation
1. Delivering on key strategic objectives
2. Rapidly advancing potential blockbuster pipeline products
3. Major news events in 2H 2016
Delivering on key strategic objectives
Execution focus
November 2015
Progress
Deliver on core R&D
Advancing 4 potential blockbusters
Divest non-core assets
Divested/ing 6 in-market products
Seek non-dilutive capital
Up to ~$1.15 billion via divestitures1
Reduce cash burn
Cutting SG&A by $65-80m per year
Optimize capital
structure
Refinancing/extending maturity for
$220m of 2017 convertible notes
1. Divested hemostat portfolio (3 products) for up to $409M including $235M in sales milestones; agreed to divest certain cardiovascular
assets (3 products) for up to $742M including $480M in sales milestones.
Delivering on key strategic objectives
Strengthened leadership
Two outstanding leaders added to the team recently
Anthony Kingsley
Christopher Cox
President
Chief Operating Officer
Executive VP
Chief Corporate
Development Officer
Delivering on key strategic objectives
Optimizing capital structure
June 6th 2016
Priced private offering of $350 m convertible senior notes1
Option to purchase up to an additional $52.5 m
Initial conv. premium 32.5% | maturity 2023 | coupon 2.75%
Capped call transaction(s)
Use of proceeds incl. repurchase ~$220 m extant 2017 notes
1. Sold under rule 144A to qualified institutional investors.
Focus
Divestment of cardiovascular hospital products
Divesting Cleviprex®, Kengreal®,
and rights to Argatroban Injection
(50mg/50mL)
Acquirer Chiesi Farmaceutici S.p.A.
and its U.S. subsidiary, Chiesi USA, Inc.
Total potential consideration
up to $792 million
Focus
Divestment of cardiovascular hospital products
Total potential consideration
$792M
Upfront payment at closing
$260M
Product inventory
$2M
Potential sales-based milestones
$480M
Future milestones due to third parties
$50M
Anticipated closing
Q3 2016
Deliver on core R&D programs
Advancing 4 potential blockbusters
Carbavance
Gram negative
CRE infections
MDCO-216
arterial plaque
regression
PCSK9si
LDL lowering
in ASCVD
ABP-700
iv sedation and
anesthesia
Deliver on core R&D programs
Advancing 4 potential blockbusters
Our lead R&D programs:
Address conspicuous unmet medical needs
Offer a highly differentiated product profile
Progressing rapidly through development phases
Target extensive global markets
PCSK9 synthesis inhibitor
Groundbreaking single dose data
Mean (+/- SEM) PCSK9 Knockdown
Relative to Baseline
-60
Max PCSK9 inhibition 88.7% - Mean max 82.3% (±2.0)1
-40
-20
0
Placebo
25 mg
20
100 mg
40
300 mg
500 mg
60
800 mg
80
100
0
1
2
3
4
5
Day/Treatment combinations where N=1 not displayed
1. AHA 2015
PCSK9 synthesis inhibitor is an investigational agent not approved for commercial use in any market
6
Months
PCSK9 synthesis inhibitor
Groundbreaking single dose data
Mean (+/- SEM) LDL-C Reduction
Relative to Baseline
-20
Max LDL-C reduction 78.1% - Mean max 59.3% (±5.0)1
0
20
Placebo
25 mg
100 mg
40
300 mg
500 mg
800 mg
60
80
0
1
2
3
4
5
Day/Treatment combinations where N=1 not displayed
1. AHA 2015
PCSK9 synthesis inhibitor is an investigational agent not approved for commercial use in any market
6
Months
PCSK9 synthesis inhibitor
ORION-1 phase II fully enrolled
Previous Phase I study:
−  PCSK9 up to 89%
−  LDL-C up to 78%
− Durable effects to 6 mth
ORION-1 study aims:
− Affirm dosage
− Confirm safety profile
− Data expected by YE 2016
Day of study
Dose in mg
(patient-n)
1
30
60
90
120 150 180 210
Q6m group
Plac (60)
200 (60)
300 (60)
500 (60)
IA
Q3m group
Plac (60)
100 (60)
200 (60)
300 (60)
Target (480)
Enrolled (501)
PCSK9 synthesis inhibitor is an investigational agent not approved for commercial use in any market
Primary
endpoint
day 180
PCSK9 synthesis inhibitor
Substantial market in US1
Potential best-in-class profile
including adherence
Lipid lowering therapy
~43.1 m
United States market 2014
− 74 m dyslipidemia patients
− 43 m on therapy
− 13 m initial target pop.
Growth with outcomes data
1° prevention
~19.2 m
2° prevention
~23.9 m
Statin
intolerant
~4.4m
High risk
(LDL-C >70 mg/mL)
FH
~0.65 m2
~7.82 m
1. Decision Resources, 2014, AHA 2015 and NHANES
2. Familial Hypercholesterolemia; US Census Data
1. Decision Resources, 2014, AHA 2015 and NHANES
2. Familial Hypercholesterolemia; US Census Data
PCSK9 synthesis inhibitor is an investigational agent not approved for commercial use in any market
MDCO-216
MILANO-PILOT trial1 progressing
Reverse cholesterol transport
− Genetic rationale
− ABCA1-mediated efflux
− Prior proof of concept in
coronary artery disease2
DSMB reviewed 24 patients
Analysis of first 40 patients as
planned ~mid-2016
1. Clinicaltrials.gov
2. Nissen, JAMA, 2003
MDCO-216 is an investigational agent not approved for commercial use in any market
MDCO-216
High risk ACS - poor prognosis
The PROSPECT trial
− 697 ACS patients followed
for median 3.4 years
20.4% MACE at 3 years
− 12.9% culprit lesions
− 11.6% non-culprit lesions
Identified risk factors
Independent correlates of MACE
events in non-culprit lesions
Correlates
HR (95% CI)
p-value
Predictors of patient-level events
Diabetes (insulin)
3.3 (1.4-7.7)
Previous PCI
2.0
(1.1-3.6)
0.005
0.02
Predictors of lesion site-level events
Plaque burden ≥70% 5.0 (2.5-10.1)
<0.001
Thin cap lesion
3.4 (1.8-6.4)
<0.001
MLA ≤4.0 mm2
3.2 (1.6-6.4)
0.001
Stone et al. N Engl J Med 2011;364:226-35.
MDCO-216 is an investigational agent not approved for commercial use in any market
MDCO-216
Substantial market opportunity
Initial target population: ACS
High risk patients
− Clinical presentation
− EKG | biomarkers
− Coronary anatomy
− Co-morbidities (diabetes)
Acute coronary syndrome
US
~1.13 million
High risk
~900,000
HCUP, NCI Primary Research
MDCO-216 is an investigational agent not approved for commercial use in any market
Europe
~1.9 million
Carbavance®
TANGO-1 phase III trial now enrolled
CRE
− CDC threat “Urgent”
− 20-50% mortality rate1
Meropenem + vaborbactam
− Superior in vitro data
− Bench to Ph III in 4 years
− TANGO-1: 550 cUTI pts
− Data read-out 2H 2016
− FDA QIDP and Fast Track
TANGO-2 phase III ongoing
Center for Disease Control
Carbavance is an investigational agent not approved for commercial use in any market
1. Center for disease control, cdc.gov
Carbavance®
Unmet medical need
CRE market opportunity in US and EU ~950,000 patients est1
Resistant strains
expected to be
susceptible2 to
Carbavance
−
90% US
−
80% EU
Pseudomonal
infections worldwide
~900,000
Enterobacteriaceae
infections worldwide
~7.5 million
Target
population
~700,000
Carbapenem
resistant
~750,000
Carbapenem
resistant
~270,000
Target
population
~250,000
1. Company primary and secondary research
2. In vitro data do not necessarily predict clinical efficacy
Carbavance® is an investigational agent not approved for commercial use in any market
ABP-700
Phase II program now underway
Clinical pharmacology | safety
established in 380 patients
Unique attributes observed1
− Rapid onset | offset
− Min respiratory depression
− No adrenal suppression
− Water soluble
− Min pain on injection
Phase II data in conscious
sedation anticipated 2H 2016
ABP-700
1. P Meyer etal, Safety, Pharmacokinetics and Pharmacodynamics of ABP-700: A Novel Intravenous Anesthetic. Presented at ISAP 2015
(International Society for Anesthetic Pharmacology Annual Meeting) October 23, 2015, San Diego, CA
ABP-700 is an investigational agent not approved for commercial use in any market
ABP-700
Potentially leading attributes
Inhaled
Propofol
Etomidate
Anticipated profile relative
to current
anesthetic
agents ABP-700
halogens
Blood pressure


–
–
Respiration



–
Adrenal function
–
–

–
Rapid induction time
–
+
+
+
Rapid recovery time
–
+
+
+++
Infusion pain
–
++
+
–
Myoclonus
–
+
++
++
ABP-700 is an investigational agent not approved for commercial use in any market
ABP-700
Large opportunity in US + EU
Intubation risk
General
anesthesia
62.8 million
Procedural
sedation
121.2 million
US: 37.3
54%
EU: 25.5
US: 61.7
51%
EU: 59.5
Patient
risk
MP 1-2
MP 3-4
ASA 3-4
27% (18.7)
3% (2.1)
ASA 1-2
63% (43.7)
7% (4.9)
Anesthesiologist
26%1
Proceduralist
74%
MDCO data
1. Estimate based on US data; EU higher
ABP-700 is an investigational agent not approved for commercial use in any market
Procedures <1 hour
ASA 1-3
US: 11.2
53%
EU: 9.7
Major news events in 2H 2016
Potential value creating R&D data
Event
Timeframe
Phase III TANGO-1 data: Carbavance®
2H 2016
Interim MILANO-PILOT data: MDCO-216
Mid-2016
ORION-2 trial start in HoFH: PCSK9si
2H 2016
Phase II data conscious sedation: ABP-700
2H 2016
Phase II ORION-1 data: PCSK9si
2H 2016
Summary
Focus on value creation
1. Delivering on key strategic objectives
2. Rapidly advancing potential blockbuster pipeline products
3. Major news events in 2H 2016