SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Area 13 or 15(d)
of the Securities Exchange Act of 1934
October 23, 2018
Date of Address (Date of ancient accident reported)
PARATEK PHARMACEUTICALS, INC.
(Exact name of Apprentice as authentic in its charter)
(State or added jurisdiction
75 Park Plaza
(Address of arch controlling offices)
(Registrant’s blast number, including breadth code)
(Former name or above address, if afflicted back aftermost report)
Check the adapted box beneath if the Form 8-K filing is advised to accompanying amuse the filing obligation of the apprentice beneath any of the afterward provisions:
Written communications pursuant to Rule 425 beneath the Securities Act (17 CFR 230.425)
Soliciting absolute pursuant to Rule 14a-12 beneath the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) beneath the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) beneath the Exchange Act (17 CFR 240.13e-4(c))
Indicate by analysis mark whether the apprentice is an arising advance aggregation as authentic in Rule 405 of the Securities Act of 1933 (230.405 of this chapter) or Rule 12b-2of the Securities Exchange Act of 1934 (§ 240 12b-2 of this chapter).
Emerging Advance Aggregation ☐
If an arising advance company, announce by a analysis mark if the apprentice has adopted not to use the continued alteration aeon for acknowledging with any new or revised banking accounting standards provided pursuant to Area 13(a) of the Exchange Act. ☐
Regulation FD Disclosure
Paratek Pharmaceuticals, Inc. (the “Company”) hosted the 2018 Paratek Investor Day on October 23, 2018. As allotment of this meeting, the Aggregation delivered the accelerate presentation absorbed to this address as Exhibit 99.1, which is congenital herein by reference.
The advice in this address (including Exhibit 99.1) is actuality furnished pursuant to Item 7.01 and shall not be accounted filed for purposes of Area 18 of the Securities Exchange Act of 1934, as adapted (the “Exchange Act”), or contrarily accountable to the liabilities of that section, nor will it be congenital by advertence in any filing beneath the Securities Act of 1933, as amended, or the Exchange Act, except as especially set alternating by specific referencing in such filing.
Item 9.01 Banking Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the apprentice has appropriately acquired this address to be active on its account by the undersigned hereunto appropriately authorized.
Date: October 23, 2018
PARATEK PHARMACEUTICALS, INC.
/s/ William M. Haskel
Name: William M. Haskel
Title: Senior Vice President, General Counsel and Corporate Secretary
Investor Day Lotte Hotel, NYC October 23, 2018 Recognizing the austere blackmail of bacterial infections, Paratek is committed to accouterment solutions that accredit absolute outcomes and advance to bigger accommodating stories. Exhibit 99.1
Paratek Pharmaceuticals 2018 Investor Day Agenda Welcoming Comments Michael F. Bigham, Chief Controlling Officer and Chairman of the Board Unmet Charge & Why NUZYRATM Matters Evan Loh, M.D., President, Chief Operating Officer & Chief Medical Officer NUZYRA Commercial Strategy: 2019 and Beyond Adam Woodrow, Chief Bartering Officer Panel Q&A with: Michael F. Bigham, CEO and Chairman of the Board Evan Loh, M.D., President, COO & CMO Adam Woodrow, CCO Douglas W. Pagán, CFO
Welcoming Comments Michael F. Bigham, Chief Controlling Officer & Chairman of the Board Recognizing the austere blackmail of bacterial infections, Paratek is committed to accouterment solutions that accredit absolute outcomes and advance to bigger accommodating stories.
Third-party industry and bazaar advice included herein has been acquired from sources believed to be reliable, but the accurateness or abyss of such advice is not affirmed by, has not been apart absolute by, and should not be construed as a representation by, Paratek. The advice independent in this presentation is authentic alone as of the date hereof. “Paratek” and the Paratek logo are trademarks and account marks of Paratek. All added trademarks, account marks, barter names, logos and cast names articular in this presentation are the acreage of their corresponding owners. Assertive statements in this presentation, including responses to questions, accommodate or may accommodate “forward-looking statements” aural the acceptation of the Private Securities Litigation Reform Act of 1995. Examples of such statements include, but are not bound to, statements about our strategy, approaching operations, prospects, plans, objectives of management, availability of abstracts from our analytic studies, abeyant use of our artefact candidates, including Omadacycline and Sarecycline, the bazaar accepting of our artefact candidates, the backbone of, and aegis offered by, our bookish acreage position, the abeyant analytic risks and adeptness of, and bazaar opportunities for, our artefact candidates, the timing and adherence of our accumulation chain, the timing of analytic development of, and authoritative approval for, our artefact candidates, and the attributes and timing of our accord agreements with account to our artefact candidates. The words “anticipate,” “estimate,” “expect,” “potential,” “will,” “project” and agnate acceding and phrases are acclimated to analyze advanced statements. These statements are based on accepted advice and accepting and are not guarantees of approaching performance. Our adeptness to adumbrate results, banking or otherwise, or the absolute aftereffect of approaching affairs or strategies, is inherently ambiguous and absolute after-effects may alter from those predicted depending on a array of factors. Our operations absorb risks and uncertainties, abounding of which are alfresco our control, and any one of which, or a aggregate of which, could materially affect our after-effects of operations or whether the advanced statements ultimately prove to be correct. Except as appropriate by law, we undertake no obligation to about amend any advanced statement, whether as a aftereffect of new information, approaching contest or otherwise. Among the risks and uncertainties that could account absolute after-effects to alter materially from those adumbrated by such advanced statements include: delays in analytic trials or abrupt results; the accident that abstracts to date and trends may not be predictive of approaching results; the abortion of collaborators to accomplish obligations beneath our accord agreements; our abortion to admission authoritative approval for our artefact candidates; if we admission authoritative approval for our artefact candidates, the accident that the acceding of such approval may absolute how we accomplish and bazaar our artefact candidates; delays in our accumulation chain, delays in adventure or commutual analytic trials; our articles not accepting the advancing accepting in the exchange or accepting actuality delayed; our articles not accepting acceding from healthcare payors; the furnishings of competition; our disability to assure our bookish acreage and proprietary technology through patents and added means; the charge for abundant added allotment to complete the development and commercialization of our artefact candidates; and the added risks declared in the “Risk Factors” area and abroad in our Annual Address on Form 10-K for the year concluded December 31, 2017, and our added filings with the SEC. PARATEK® and the Hexagon Logo are registered trademarks of Paratek Pharmaceuticals, Inc. NUZYRA and its architecture logo are trademarks of Paratek Pharmaceuticals, Inc. Safe Harbor Statement
Paratek Pipeline Compelling Life-cycle Opportunities Research Preclinical Phase 1 Phase 2 Phase 3 Pre-Registration NDA Filing NDA Approved Bartering Rights SEYSARATM (sarecycline) (U.S.) (ex-U.S.) (Global*) uUTI (IV & Oral) – QIDP ABSSSI (IV & Oral) – QIDP SPA CABP (IV & Oral) – QIDP SPA Inflammatory Acne (Acne Vulgaris) * We accept entered into a accord acceding with Zai Lab (Shanghai) Co., Ld., for greater China arena ABSSSI (Oral alone ) – QIDP Biodefense Pathogens NUZYRA 100mg for bang & 150mg tablets FDA Animal Rule Pyelonephritis (IV & Oral) – QIDP
Strong Track Record Delivering on Milestones Omadacycline Contest Timing After-effects ABSSSI Phase 3 data: IV and articulate Q2 2016 Absolute Phase 3 abstracts UTI Phase 1b data: PK/PD Q4 2016 Proof-of-principle CABP Phase 3 data: IV and articulate Q2 2017 Absolute Phase 3 abstracts ABSSSI Phase 3 data: Oral-only Q3 2017 Absolute Phase 3 abstracts UTI Phase 2 admission Q4 2017 Enrolling NDA approval Oct 2018 Approved Projected U.S. Launch Feb 2019 Projected EMA Approval H2 2019 Sarecycline Events1 Timing After-effects Phase 3 adeptness studies Q1 2017 Absolute Phase 3 abstracts NDA Approval Oct 2018 Approved Projected U.S. Launch Jan 2019 Almirall, S.A. accountant U.S. development & bartering rights
Well-Positioned for Approaching Advance Focused on Execution New Value Creation Near-term Focus New Sources of Value Launch of NUZYRA Prudent Operating Expense Administration Non-Dilutive Sources of Capital Life-cycle Opportunities for NUZYRA Bio-Defense Artefact / Pipeline Expansion
Strong Antithesis Sheet Key Metrics (unaudited) 6/30/18 antithesis Absolute Cash, Cash Equivalents, and Marketable Securities $321.1 actor Gross Long-term Debt Obligation $218.5 actor Basic Shares Outstanding 31,443,149 Stock Options, Restricted Stock Units, and Warrants Outstanding 5,760,108 Allotment Projected through Q1 2021
Unmet Charge & Why NUZYRA Matters Evan Loh, M.D., President, Chief Operating Officer, Chief Medical Officer Recognizing the austere blackmail of bacterial infections, Paratek is committed to accouterment solutions that accredit absolute outcomes and advance to bigger accommodating stories.
The Growing Antimicrobial Resistance (AMR) Crisis Is Actuality Today, Life-Threatening and Costly More Deaths from AMR than Cancer in 2050
NUZYRA…Broad Label Approved on October 2, 2018 Community-acquired bacterial pneumonia (CABP) in adults Acute bacterial bark and bark anatomy infections (ABSSSI) in adults First Once-daily IV and Articulate Antibacterial to be FDA Approved to Treat Both CABP and ABSSSI in Nearly 20 Years
Significant Unmet Charge in CABP Important Demography: Together with influenza, CABP is currently the eighth arch account of afterlife in the U.S.3 All account 30-day bloodshed in ailing patients exceeds 10%4-6 Analysis Rates in CABP are added in earlier populations and in populations with assertive co-morbid conditions, including COPD, CHF, and diabetes7 1. McLaughlin et al. Infection 2015; 43:671–680. 2. Jain et al. N Engl J Med 2015; 373:415-27. 3. Xu J, et al. National Center for Health Statistics, National Vital Statistics System. 2016; 64(2):1–119. 4. Johnstone J, et al Medicine (Baltimore). 2008; 87(6):329-34. 5. Metersky ML, et al. Chest. 2012 Aug;142(2):476-81. 6. Violi F, et al. Clin Infect Dis. 2017; 64(11):1486–93. 7. Ramirez et al. Clin Infect Dis. 2017; 65(11):1806-1812. 8. . Mandell LA, et al. Analytic Infectious Diseases 2007; 44:S27–72.
NUZYRA Opportunities Beyond Accepted CABP Treatment Options: Addressing Bound Formulations with Safety Concerns 1. McLaughlin et al. Infection 2015; 43:671–680. 2. Jain et al. N Engl J Med 2015; 373:415-27. 3. Xu J, et al. National Center for Health Statistics, National Vital Statistics System. 2016; 64(2):1–119. 4. Johnstone J, et al Medicine (Baltimore). 2008; 87(6):329-34. 5. Metersky ML, et al. Chest. 2012 Aug;142(2):476-81. 6. Violi F, et al. Clin Infect Dis. 2017; 64(11):1486–93. 7. Ramirez et al. Clin Infect Dis. 2017; 65(11):1806-1812. 8. . Mandell LA, et al. Analytic Infectious Diseases 2007; 44:S27–72. Beta-lactam‡ Macrolide Respiratory Fluoroquinolone Inpatient Rx Non-ICU8 OR NUZYRA as First-Line Therapy: Monotherapy, IV Oral, back β-lactam/Macrolide or Quinolones are not options
Scarcity of Able & Safe Ample Spectrum IV Articulate Antibiotics NUZYRA: First Once-daily CABP Indication Approved in Nearly 20 Years 1990’s 2010 2016 2018 2000 ZIGAN Articulate TROVAN IV/Oral KETEK Articulate TEQUIN IV/Oral LEVAQUIN IV/Oral AVELOX IV/Oral SOLITHERA IV/Oral 2016 Withdrawn from the bazaar due to Toxicity Generic CRL from FDA; Liver toxicity ZITHROMAX IV/Oral
Significant Unmet Charge in Bark Infections Important Demography: Incidence of bark infections acute analysis has essentially added back the 2000’s1,3 ~ 870,000 admissions, 6.3M appointment visits, and 3.4M emergency administration visits annually5 Underlying co-morbidities including diabetes and vascular ache can complicate administration and antibacterial selection4 1.Kaye KS, et al. 2015. PLoS One, 10(11): e0143276 2. Ray et al. BMC Infectious Diseases 2013; 13:252. 3. Esposito et al. Curr Opin Infect Dis 2016, 29:109–115. 4. Pulido-Cejudo A, et al. Ther Adv Infectious Dis 2017; 4(5):143–61. 5. Lodise et al. Hosp Pract, 2015; 43(3): 137–143
NUZYRA Opportunities Beyond Today’s Bark Treatment Options: Addressing Bound Formulations with Safety Concerns 1.Kaye KS, et al. 2015. PLoS One, 10(11): e0143276 2. Ray et al. BMC Infectious Diseases 2013; 13:252. 3. Esposito et al. Curr Opin Infect Dis 2016, 29:109–115. 4. Pulido-Cejudo A, et al. Ther Adv Infectious Dis 2017; 4(5):143–61. 5. Lodise et al. Hosp Pract, 2015; 43(3): 137–143 Vancomycin /- Pip/Tazo Zyvox /- Pip/Tazo Inpatient Rx OR NUZYRA as First-Line Therapy: Monotherapy, IV Oral, back Vancomycin/Zyvox /- Pip/Tazo are not options
NUZYRA: A Modernized Tetracycline Restoring Tetracycline Adeptness with Convenience Attributes 9-Position Modification: Overcomes Ribosomal Aegis 7-Position Modification: Overcomes Efflux Pump T1/2 = 16 Hours Analytic and in-vitro action adjoin select: Gram-positives, Gram-negatives, Atypicals, Drug-resistant strains Not metaized No P450 Interactions Biliary and renal elimination
NUZYRA: A Modernized Tetracycline Clinically Meaningful Attributes Drive Balloon to Adoption Once-daily IV & Articulate High & abiding analytic adeptness No dosage modifications or ecology in hepatic or renal crime No QTc assiduity Low abeyant for DDIs No cases of C. animosity appear in completed analytic affairs HCP aplomb in alleviative patients Adeptness Safety Tolerability Adeptness from hospital to home Helps abbreviate hospitalization
Bartering Strategy: 2019 and Beyond Adam Woodrow, Chief Bartering Officer Recognizing the austere blackmail of bacterial infections, Paratek is committed to accouterment solutions that accredit absolute outcomes and advance to bigger accommodating stories.
MSDs Hired/ Deployed NDA Submitted NDA Planned Payer Acceding and Barter Discussions Finalize Pricing Scientific Exchange Account Teams Hired Publications/News Flow Continues KPI Dashboard Budget Impact Model and Health Economic Analysis and Publications Sales Teams Hired and Trained Authoritative Artefact Accumulation Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar 2017 2018 2019 Bartering Readiness: – Bartering Team Hired – Payer Mktg Team Hired – Advisory Boards – Bazaar Research – Ache State Education – Initial Payer Research – Campaign Development Launch Planned NUZYRA: U.S. Timeline Investor Day 2018 Trademark Review Complete Sales Administration & ISR Hired Investor Day 2017
MSDs Hired/ Deployed NDA Submitted NDA Accepted Payer Acceding and Barter Discussions Finalize Pricing Scientific Exchange Account Teams Hired Publications/News Flow Continues KPI Dashboard Budget Impact Model and Health Economic Analysis and Publications Sales Teams Hired and Trained Authoritative Artefact Accumulation Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar 2017 2018 2019 Bartering Readiness: – Bartering Team Hired – Payer Mktg Team Hired – Advisory Boards – Bazaar Research – Ache State Education – Initial Payer Research – Campaign Development Launch Complete Planned NUZYRA: U.S. Timeline Launch February 2019 Trademark Review Complete Sales Administration & ISR Hired Approved Ad Comm Completed Investor Day 2018
Success Begins in the Hospital with Specialists “Go-Home” Action to Abbreviate Hospital Stay IDs ER HCPs Hospitalists Pulmonologists PharmD IDs Allied HCPs Launch and Beyond HOSPITAL Internal Medicine Primary Affliction Provider NPs, PAs Urgent Affliction Year 2 and Beyond COMMUNITY
Paving The Path For a Successful Launch Bazaar Admission Followed by Bartering Execution for Demand Bearing 2018 2019 2020 Oct ‘18 – Jan ‘19 Execution by Select Customer-Facing Team Arrangement negotiations Pre-orders Qualify key accounts Appointments February ‘19 – Forward Execution by Sales Force & Bazaar Admission Customer-Facing Teams Continue institutional admission Demand bearing
Influencers: IDs PharmD IDs Pharmacy Directors Microbiologists = Field Force Has Two Simultaneous Objectives Institutional Admission Demand Bearing Adoption Formulary/Protocols Specialty Admission & Buying Institutional Admission Prescribers: IDs ER Hospitalists Pulmonologists Balloon & Usage Demand Bearing
Focused Launch Targeting Early Adopters Expansion to ~80 Representatives by Year End 2019 Physician Segments Guideline and agreement apprenticed Wait for Early Adopters to balloon and use Convenient appearance with IV to articulate alteration Focused on ample spectrum and adeptness Launch in February 2019 with 40 Sales Specialists Focusing on ‘Early Adopting’ HCPs in ‘high value’ institutions (~400), will drive institutional admission By end of 2019, plan to accept a absolute of ~80 Sales Specialists targeting 800 institutions Central Sales Team will supplement efforts of Sales Specialists and augment beat Early Adopter Late Adopter
More Articulate Options New Therapies to Overcome Drug Resistance Greater Safety Alternative to Quinolones There are Unmet Needs that NUZYRA Will Abode Reduce Hospital Length of Stay Reduce Nursing Time Lack of Different Class Options Reduce Usage of Multi-Drug Combinations NUZYRA Attributes Provide A Modern-Day Solution Unmet Charge Confirmed Through Physician Research Known Safety Profile Established Adeptness in a Monotherapy Equivalent IV & Articulate Physicians Recognize the Absolute Attributes of NUZYRA Modernized Tetracycline Aplomb to Acquittal Accommodating Once Daily Dosing Reduce Nursing Time Lower C.diff Abeyant Source: Paratek Sponsored Bazaar Research
NUZYRA: As First-line Therapy Targeted Accommodating Profiles CABP ABSSSI Alternative to fluoroquinolone β-lactam allergic Prior C. difficile infection Suspected polymicrobial infection β-lactam / sulfa allergic Renal dearth SSRI
Ensure Seamless Alteration from Hospital to Home Continuity of Affliction Accouterment Admission to Articulate NUZYRA Continuity of Affliction Prevent gap in affliction Sample / Bridge Affairs (as needed) Acceding Support Services Affordability Affairs 3 Distribution Network IV Conception National & Regional Distributors Articulate Conception National & Regional Pharmacies Affairs allows for articulate conception analeptic at retail locations or home commitment HUB Services Enables able acquittal action
Early Indicators to Track Achievement 1 Covered Lives Institutional Admission 3 months Post-Launch 33% of covered lives beneath arrangement 12 months Post-Launch 66% of covered lives beneath arrangement 12 months Post-Launch 70% of 800 targeted institutions
History Can Repeat Itself… Today: Slower starts…But with the Right Attributes, a Strong Finish Recent AB Launches: antibiotics launched back 2010 that accept at atomic 36 months of abstracts – Avycaz, Dalvance, Orbactiv, Sivextro, Teflaro, & Zerbaxa (does not accommodate Dificid or new formulations/line extensions) *MAT = 12-month rolling absolute
NUZYRA Coming Soon…February 2019 1
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