PRTK 2015 JPM Presentation - Paratek Pharmaceuticals, Inc.

Late Stage, Novel Antibiotics
January 2015
Not for Distribution
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Confidential
Third-party information included herein has been obtained from sources believed to be reliable, but the accuracy or completeness of such
information is not guaranteed by, and should not be construed as a representation by Paratek Pharmaceuticals, Inc. (“Paratek”). The
information contained in this presentation is accurate only as of the date hereof. “Paratek” and the Paratek logo are trademarks and
service marks of Paratek. All other trademarks, service marks, trade names, logos and brand names identified in this presentation are the
property of their respective owners.
Forward-Looking Statements / Risk Factors
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to, our strategy, future operations, future financial position, future revenue, projected costs,
prospects, plans, objectives of management, potential use and effectiveness of our product candidates, expected market growth, the
market opportunity for and the market acceptance of our product candidates, and the strength of our intellectual property portfolio.
Examples of such statements include, but are not limited to, statements relating to the potential clinical risks and efficacy of, and market
opportunities for, our product candidates, including Omadacycline and Sarecycline, the timing of clinical development of, and regulatory
approval for, our product candidates, and the nature and timing of our collaboration agreements with respect to our product candidates.
The words “anticipate,” “estimate,” “expect,” “believe,” “will” and similar terms and phrases are used to identify forward-looking
statements. These statements are based on current information and belief and are not guarantees of future performance. Our ability to
predict results, financial or otherwise, or the actual effect of future plans or strategies is inherently uncertain and actual results may differ
from those predicted depending on a variety of factors. Our operations involve risks and uncertainties, many of which are outside our
control, and any one of which, or a combination of which, could materially affect our results of operations or whether the forward-looking
statements ultimately prove to be correct. We undertake no obligation to publicly update forward-looking statements, whether as a result
of new information, future events or otherwise. Among the risks and uncertainties that could cause actual results to differ materially from
those indicated by such forward-looking statements include delays in clinical trials or unexpected results; the failure of collaborators to
perform obligations under our collaboration agreements; our failure to obtain regulatory approval for our product candidates; our products
not gaining the anticipated acceptance in the marketplace or acceptance being delayed; our products not receiving reimbursement from
healthcare payors; the effects of competition; our inability to protect our intellectual property and proprietary technology through patents
and other means and the risks described in the “Risk Factors” sections of the Registration Statement on Form S-4 (file no 333-198464) and
Paratek’s periodic reports filed with the SEC.
Not for Distribution
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Confidential
Investment Highlights
• Proven Management Team
• 2 Late stage products:
– Omadacycline: Worldwide rights retained
- ABSSSI Phase 3: SPA + QIDP
- CABP Phase 3: SPA + QIDP
- UTI program being finalized: QIDP
- Oral & IV commercial formulations
– Sarecycline: Ex-US rights retained
– Partnered with Actavis in U.S.
• Regulatory certainty: GAIN Act
• Growing pricing power
• Scarcity of late-stage, broad spectrum antibiotics
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Confidential
Proven Management Team:
Delivering Major Antibiotics to
the Market Building Leading Companies
Michael F. Bigham
Susan Perkins
CEO
VP, Intellectual Property
Evan Loh, MD
Evan Tzanis
President & CMO
VP, Clinical Development
Led Tygacil development
Adam Woodrow
Sean M. Johnston, PhD
Chief Commerical Officer
VP, Manufacturing
Led Tygacil Commercialization
Doug Pagan
S. Ken Tanaka, PhD
Chief Financial Officer
VP, Research and Development
Developed clarithromycin, temofloxacin
Not for Distribution
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Confidential
Board of Directors
Experienced Stewardship
Michael F. Bigham
Chairman
Evan Loh, MD
Director
Richard Lim
Director
Jeffrey Stein, PhD
Director
Robert Radie
Director
Thomas Dietz, PhD
Director
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Confidential
Paratek’s Pipeline
Two Phase 3 Ready Candidates
Research
Preclinical
Phase 1
ABSSSI (Oral & IV) – FDA QIDP status
Omadacycline(1)
CABP (Oral & IV) – FDA QIDP status
Phase 2
Phase 3
Commercial Rights
SPA
SPA
UTI (Oral & IV) – FDA QIDP status
Sarecycline U.S.(2)
(WC 3035)
Acne (oral)
(1) Paratek
Owns Worldwide Rights
(2) Paratek
Owns Ex-US Rights
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Confidential
Resistance: Growing Threat
•
•
•
•
•
Unique to infectious disease
Confers in-built “product obsolescence”
Arises within a product’s lifetime
Renders “generics” less relevant
Costs billions
–
U.S. antibiotic resistance costs > $20 billion a year in excess health care costs,
$35 billion societal costs and >8 million additional days patients spend in the hospital(1).
(2)
(1)
(2)
Not for Distribution
Roberts RR, Hota B, Ahmad I, Scott RD 2nd, Foster SD, Abbasi F, Schabowski S, Kampe LM, Ciavarella GG, Supino M, Naples J, Cordell R, Levy SB, Weinstein RA.
Clin Infect Dis. 2009 Oct 15;49(8):1175-84. doi: 10.1086/605630
Cover Time August 3rd 1998
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Confidential
Omadacycline Potential
Proven Power of Oral and IV Formulations
Combined with the Importance of the “Big 3”* Indications
Antibiotic
Inventor
Form
Indications
Levaquin (J&J)
Pharma
Oral & IV
Skin, Respiratory Tract, UTI
Augmentin (GSK)
Pharma
Oral & IV
Skin, Upper Resp Tract, UTI
Zithromax (Pfizer)
Pharma
Oral & IV
Upper & Lower Resp Tract
Cipro (Bayer)
Pharma
Oral & IV
Skin, Respiratory Tract UTI
Biaxin (Abbott)
Pharma
Oral & IV
Upper & Lower Resp Tract
Zyvox (Pfizer)
Pharma
Oral & IV
Skin , Hospital Acquired Pneumo
Zosyn (Pfizer)
Pharma
IV
Resp Tract, Skin, Urinary Tract
Rocephin (Roche)
Pharma
IV
Resp Tract, Skin, Urinary Tract
Mefoxin (Merck)
Pharma
IV
Resp Tract, Skin, Urinary Tract
Primaxin (Merck)
Pharma
IV
Resp Tract, Skin, Urinary Tract
Cubicin (Cubist/Lilly)
VC Backed Co
IV
Skin, Endocarditis
Blockbuster
>$1.5B
History of “Concurrent” Blockbusters
Oral Use ~Two-thirds of Total Revenues
* Skin, Respiratory Tract, UTI
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Growing Pressure for Broad-Spectrum
• Accountable care/managed care: Drive Broad-Spectrum Community Use
– Capitation/fee for service models
– Decreasing time with patients
– Culture “turnaround times” too long
– Pressure to keep people out of hospital
– Financial penalties for failing to “get it right” first time
Scarcity of phase 3, broad-spectrum, community-based antibiotics
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Generics are not the Issue
• Resistance renders generic antibiotics less relevant
• New pricing paradigm: Prices rising
– Differentiation: Efficacy and tolerability
– Meeting unmet medical need
• Identifying patients to be “right the first time”
• Payer pressure: keep patients out of hospital
‒ Penalties for readmissions
• The “wrong” antibiotic is the most expensive
‒ Particularly for patients “at risk”
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Omadacycline
• Broad-spectrum IV and oral antibiotic
– Serious community-acquired infections
– Where resistance is of concern
• Powerful Profile:
– Once-daily dosing
– Multiple indications: Pursuing The “Big 3”
• ABSSI: Skin
• CABP: Pneumonia
• UTI: Urinary Tract Infection
– Safety and tolerability profile
• Matches community-based needs
– Commercial scale, stable formulations
• IV and oral
Not for Distribution
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Confidential
Twin Mechanisms of Tetracycline Resistance
Efflux Pump
Not for Distribution
Ribosomal Protection
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A New Generation of Tetracyclines:
Aminomethylcyclines
7-Position Modification:
Overcomes Efflux Pump
R2
R3
H H
N
OH
R1 N
O
OH O HO H O O
NH2
9-Position Modification:
Overcomes Ribosomal Protection
Not for Distribution
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Confidential
Omadacycline Potency Against Key Resistant ABSSSI Pathogens
Organism
(# Isolates)
Omadacycline
Vancomycin
(Vancocin)
Linezolid
(Zyvox)
Levofloxacin
(Levaquin)
Ceftriaxone
(Rocephin)
Amox-Clav
(Augmentin)
Azithromycin
(Zithromax)
MIC90 (µg/ml)
MRSA (111)
0.25
1
4
>8
>64
>8
>8
MSSA (52)
0.25
1
2
2
4
1
>8
S. pyogenes (104)
0.12
0.5
2
1
0.03
0.015
>4
• Resistance (high MICs) of key pathogens limits the reliability of current antibiotic therapies
• Omadacycline broad-spectrum activity provides potential as monotherapy for ABSSSI,
CABP and UTI
Not for Distribution
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Omadacycline Potency Against Key Resistant CABP Pathogens
Organism
(# Isolates)
Omadacycline
Levofloxacin
(Levaquin)
Azithromycin
(Zithromax)
Ceftriaxone
(Rocephin)
Amox-Clav
(Augmentin)
Vancomycin
(Vancocin)
MIC90 (µg/ml)
MRSA (111)
0.25
>8
>8
>64
>8
1
PRSP (51)
0.12
1
>4
2
8
1
H. influenzae (105)
1
0.03
4
0.008
1
Not
Active
Not
Not
Not
Active
Active
Active
• Resistance (high MICs) of key pathogens limits the reliability of current antibiotic
therapies
Legionella (25)
0.25
<0.03*
0.5
• Omadacycline broad-spectrum activity provides potential as monotherapy for ABSSSI,
CABP and UTI
*Indicates data is from moxifloxacin; J. Dubois et al. 2006
Not for Distribution
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Confidential
128
Not
Active
Vancomycin
(Vancocin)
16
Levofloxacin
(Levaquin)
4
Linezolid
(Zyvox)
Ceftriaxone
(Rocephin)
E. Coli ESBL+
(102)
Amox-Clav
(Augmentin)
Organism
(# Isolates)
Omadacycline
Omadacycline Potency Against Key Resistant UTI Pathogen+
>16
Not
Active
• Resistance (high MICs) of key pathogens limits the reliability of current antibiotic
therapies
• Omadacycline broad-spectrum activity provides potential as monotherapy for
ABSSSI, CABP and UTI
+ CMI 2007 report to Paratek
Not for Distribution
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Omadacycline Comparable to Linezolid(1)
Combined Data from Phase 2 and Phase 3 Non-Registration Trials
Clinical Success Rate(3)
Population(2)
Omadacycline
Linezolid
Intent to Treat (ITT)
87.2% (156/179)
81.1% (146/180)
Clinically Evaluable (CE)
97.5% (156/160)
94.2% (146/155)
(1)
The table shows combined data from our Phase 2 and Phase 3 non-registration trials, neither of which had a
sufficient number of patients enrolled to determine statistical non-inferiority.
(2) An Intent-to-Treat, or ITT, population refers to all enrolled subjects, as defined in the protocol, who received
at least one dose of study drug. A Clinically Evaluable, or CE, population refers to all ITT subjects who had a
qualifying infection, as defined in the protocol.
(3) Clinical success refers to the continued improvement or complete resolution of baseline symptoms in the ITT
or CE populations, assessed by the clinical investigator 10 to 17 days after the last dose of study drug.
Not for Distribution
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Omadacycline Comparable to Linezolid
with New FDA End Points
Early (48-72 Hour) Clinical Response(1,3)
Among ITT(2) Patients Following 48-2 Hours of Therapy
100
92.5%
88.9%
Omadacycline
Linezolid
N=40
N=45
Percent of N
75
50
25
0
Omadacycline Early Clinical Response Rates to Linezolid in Randomized Phase 2 & Phase 3 non-Registration cSSSI Trials
(Retrospective Analysis)
(1)
Defined as decrease in lesion size of 20% or more (analysis based on single maximum dimension)
ITT = Intent-to-Treat
(3) Retrospective analysis where early time point data available excluding DFI
(2)
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Omadacycline Safety and Tolerability
Promising Profile
• ~700 individuals treated to-date
• No hERG channel effects: TQTc(1) study completed
• No effects on heart rate (HR) in patients
– Modest transient vagolytic HR effect in healthy volunteers
• No metabolites
• No CYP interactions
• No DDI effects anticipated
• Modest GI effects
– No nausea-vomiting seen in IV-oral cross-over study
• No anticipated monitoring
(1) Thorough
Not for Distribution
QTc study
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Robust Commercial-Scale Formulations
• BOTH oral tablet and IV: at commercial-scale
• Stability profile (>2 years) for both oral and IV
• Oral tablet: meets FDA bioequivalence test
• Dosing regimens:
‒ IV: 100 mg every 12 hours for two doses:
followed by 100 mg every 24 hr
‒ Oral: 300 mg dosed as two 150 mg tablets every 24 hr
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Confidential
Phase 3 Trial Designs: Meets Both FDA and EMA Guidelines
ABSSSI
650 patients
Omadacycline
IV
Omadacycline
Oral
Linezolid
IV
Linezolid
Oral
d1
d2-3
Up to d14
End of Treatment
Early Response
CABP
750 patients
Omadacycline
IV
Omadacycline
Oral
Moxifloxacin
IV
Moxifloxacin
Oral
d1
d3-5
d3 – 5
(1) TOC
Early Response
Up to d14
End of Treatment
d5-14
d16-20
Test of Cure(1)
d16-20
Test of Cure(1)
endpoint = Primary endpoint within EMA guidance
Not for Distribution
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Omadacycline: Promising Treatment for UTI
• 97.1% of surveyed physicians believe that their patients with
resistant E. coli could benefit from a new antibiotic*
• Omadacycline: Promising UTI Profile
‒ Activity against most prevalent UTI pathogen E.coli (1)
‒ >40% Renal clearance
‒ Once-daily oral tablet; plus an IV formulation
‒ Safety and tolerability profile: matches community-based needs
• Clinical development plans being finalized
* Medacorp survey 1Q 2013
(1) 2007 CMI Report to Paratek
Not for Distribution
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Omadacycline: Strong IP Through 2028
• Composition of Matter protection through 2028
‒ U.S. Base Composition of Matter – June 2023
‒ Anticipated patent term extension into 2028
‒ GAIN Act extension of US data exclusivity (up to 5 yrs.) @approval
‒ Pediatric exclusivity – additional 6 months
‒ EU: 10 yrs. of market exclusivity expected
Not for Distribution
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Sarecycline:
Specifically Designed for Inflammatory Acne
• Novel, narrow-spectrum antibiotic
• Demonstrated anti-inflammatory activity
• Does not cross Blood-Brain Barrier
‒ Reduced GI side effects
• Once-daily Oral formulation
• Composition of Matter IP protection
‒ U.S. Base Composition of Matter through March 2031
‒ Pediatric exclusivity – additional 6 months
‒ EU: 10 years of market exclusivity expected
Not for Distribution
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Sarecycline Partnership with Actavis
•
•
•
•
U.S. rights: Actavis
Ex-U.S. rights: Paratek
Phase 3 Trials in U.S. underway
Milestones and royalties to Paratek
• Analogues confirm Acne Rx potential:
‒ Doryx: peak U.S. sales >$200M (reformulated doxycycline)
‒ Solodyn: peak U.S. sales $400M+ (reformulated minocycline)
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Financial Summary
• Merger with Transept closed October 30th 2014
• “Free” cash on hand ~$100M
• Leading investors include:
–
–
–
–
–
–
Abingworth
Baupost Group
Fidelity
HBM Healthcare Investments
Interwest Ventures
Omega Funds
• IR Action Plan : Life science advisors
– Broaden investor base
– Expand analyst coverage
• Business development opportunities
– Sarecycline: Ex-US rights
– Sarecycline: Monetize potential royalties
– Omadacycline: “Regional rights”
Not for Distribution
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Investment Highlights
• Proven Management Team
• 2 Late-stage products:
– Omadacycline: Worldwide rights retained
- ABSSSI Phase 3: SPA + QIDP
- CABP Phase 3: SPA + QIDP
- UTI program being finalized: QIDP
- Oral & IV commercial formulations
– Sarecycline: Ex-US rights retained
- Partnered with Actavis in U.S.
• Regulatory certainty: GAIN Act
• Growing pricing power
• Scarcity of late-stage, broad-spectrum antibiotics
Not for Distribution
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