Download PRTK Feb 2015 Cowen Presentation

Late Stage, Novel Antibiotics
February 2015
Not for Distribution
3/3/2015 1
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.
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Investment Highlights
 Proven Management Team
 Demonstrated large pharma interest
 Regulatory certainty: GAIN Act
 Growing pricing power
 2 Late stage products:
 Omadacycline: Worldwide rights retained
 ABSSSI Phase 3: SPA + QIDP
 CABP Phase 3: SPA + QIDP
 UTI program in development + QIDP
 Sarecycline: Ex-U.S. rights retained
 Partnered with Actavis in U.S.
 Scarcity of other late-stage opportunities
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Decline in Antibiotic Development and Approvals
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Bacteria Always Win
 Bacterial resistance renders generic products obsolete
 Bacterial resistance costs society billions $USD
 > $20 billion USD/year in excess health care costs
 ~ $35 billion USD societal costs
 > 8 million additional patient days(1)
REPORT TO THE PRESIDENT ON COMBATING
(2)
ANTIBIOTIC RESISTANCE
Executive Office of the President
President’s Council of Advisors on Science
and Technology
September 2014
(1)
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
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U.S. Government Bills “on the Hill”
Source: Guggenheim analyst report (Feb 2015)
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Aminomethylcyclines: A New Generation Tetracycline
Overcomes These Mechanisms
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
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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.
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Phase 3 Trial Designs: Meet Both FDA and EMA Guidelines*
ABSSSI
650 patients
Omadacycline
IV
Omadacycline
Oral
Linezolid
IV
Linezolid
Oral
d1
d2-3
Up to d14
Early Response
CABP
750 patients
Omadacycline
IV
Omadacycline
Oral
Moxifloxacin
IV
Moxifloxacin
Oral
d1
d3-5
d3 – 5
Early Response
d16-20
End of Treatment
Post Treatment
Evaluation, Test of Cure(1)
Up to d14
d16-20
End of Treatment
d5-14
Post Treatment
Evaluation, Test of Cure(1)
(*)Approval of 1 + 1 strategy in EU subject to scientific advice
(1) TOC endpoint = Primary endpoint within EMA guidance
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Omadacycline:
Promising Safety and Tolerability 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 known metabolites
 No CYP interactions identified
 No DDI effects anticipated
 Modest GI effects
 No nausea-vomiting seen in IV-oral cross-over study
 No anticipated monitoring
(1) Thorough
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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Omadacycline: Strong IP Through 2028
 Protection through 2028
 U.S. Base Composition of Matter plus anticipated patent term
extension into 2028
OR
 U.S. Hatch Waxman plus GAIN Act extension into 2028
 EU: 10 yrs. of market exclusivity expected
 Potential Pediatric exclusivity – adds additional 6 months
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Omadacycline:
Proven Power of well tolerated Oral and IV Formulations
Combined with the Importance of the “Big 3”* Indications
Antibiotic
Class
Form
Indications
Blockbuster
>$1.5B
Peak Yr. (1)
Levofloxacin
Quinolone
Oral & IV
Skin, Respiratory Tract, UTI
2010
Co-Amoxy clav
B-Lactam
Oral & IV
Skin, Upper Resp Tract, UTI
2011
Azithromycin
Macrolide
Oral & IV
Upper & Lower Resp Tract
2011
Ciprofloxacin
Quinolone
Oral & IV
Skin, Respiratory Tract UTI
2009
Clarithromycin
Macrolide
Oral & IV
Upper & Lower Resp Tract
2011
History of “Concurrent” Blockbusters
Oral Use ~Two-thirds of Total Revenues
* Skin, Respiratory , UTI
(1) IMS Data 2014
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Retail Opportunity > 10X Hospital(1,2,3)
Retail Rx’s Target Mkt MM
Hospital Antibiotic Treated Events MM
(1) Decision
Resources Hospital-Treated Infections 2014
Resources Community-Acquired Pneumonia 2012
(3) IMS 2014 MIDAS Rx Global Data Defined Market Azithromycin, Ciprofloxacin, Clarithromycin, Co-Amoxyclav, Levofloxacin, Linezolid
* Respiratory includes Upper respiratory tract infections in retail Rx’s e.g. Bronchitis, CABP, Sinusitis, Otitis Media etc.
(2) Decision
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Omadacycline:
Broad Opportunity with Few Late-Stage Competitors
Hospital
cIAI
cUTI
ABSSSI CABP
Community
CABP
ABSSSI
UTI
Other
Omadacycline
Eravacycline
Solithromycin
Neisseria
Delafloxacin
Finafloxacin
Lefamulin
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Financial Summary
 Merger with Transcept closed October 30th 2014
 Cash ~$100M (January 2015)
 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-U.S. rights
 Sarecycline: Monetize potential royalties
 Omadacycline: “Regional rights”
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