AKAO Corporate Presentation - Seeking Alpha

Corporate PresentationMarch 2019

Nasdaq: AKAO

2

Forward Looking Statements

This presentation contains forward-looking statements. All statements other than statements of historical facts contained hereinare forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, certain preliminary unaudited financial figures, the commercial and clinical potential of ZEMDRI (plazomicin), Achaogen’s strategic and commercial objectives and the Achaogen pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Achaogen's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties of commercialization and gaining market acceptance, uncertainties inherent in the development process, the risks and uncertainties of the regulatory approval process and the risk when bacteria will evolve resistance to ZEMDRI. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Achaogen business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 27, 2018, and its Quarterly Report on Form 10-Q filed on November 8, 2018. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this presentation, whether as a result of any new information, future events, changed circumstances, or otherwise.

For investor purposes only. Not for promotional use.© Achaogen, Inc. All rights reserved.

3

Achaogen: Innovative Products for Serious Infections

Unique Antibacterial Company

• Addressing the threat of MDR bacterial infections

• ZEMDRI (plazomicin) commercial launch underway

• Reviewing strategic alternatives and restructured organization

Significant Commercial Opportunity

• Large and growing patient populations

• Unmet need in the hospital and outpatient settings

• Strong physician interest

ZEMDRI®Launched andavailable for use

• Novel once-daily antibiotic

• Versatile across inpatient and outpatient settings

• CRE and ESBL activity

• Lean commercial model focused on concentrated markets

• MAA review underway in EU

Innovative Pipeline

• C-Scape: oral candidate for cUTI

• Ceftibuten and Clavulanate combination potent against ESBLs

• Second Phase 1 in 2019 followed by Phase 3

• BARDA support


4

Multi-Drug Resistance Poses an Urgent and Growing Threat

• Resistance rising rapidly2

• High morbidity and mortality (up to 50% in BSI due to CRE)1,3

• Limited treatment options4

• Significant economic burden to healthcare system & society5

CDC Urgent1 CDC Serious1

Priority Pathogens

1 CDC Antibiotic Resistance Threats in the United States, 2013 http://www.cdc.gov/drugresistance/threat-report-2013/2 The Surveillance Network database: CDDEP.org Resistance Map; Braykov et. al., 20133 Ben-David et al. Clin Microbiol Infect 2012;18(1):54–60.4 Daikos et al., Clin Microbiol Rev. 2012 Oct;25(4):682-707.5 Bartsch et al., Clin Microbiol Infect. 2016 Sep 15. pii: S1198-743X(16)30389-5.WHO published Feb. 27, 2017


5

There is a Demand for New Therapies to Fight MDR Infections

1 Diagn Microbiol Infect Dis 2016, http://dx.doi.org/10.1016/j.diagmicrobio.2016.04.022 E.coli is the causative pathogen in 79% of complicated UTI (incl. pyelonephritis): Lancet 2015;385:1949.2. Source: Decision Resources AMR Hospital Antibiotic Market Guide; Data annualized from half-year datasets: 2004-H2, 2006-H2, 2009-H2, 2011-H1, 2014-H1. UTI diagnosis codes include UTI/cystitis/urosepsis and pyelonephritis/perinephric abscess.3 Europe: Population-weighted average of 30 European countries, calculated from: Non-susceptibility: ECDC EARS-Net, http://ecdc.europa.eu/, 2016 (Klebsiella pneumoniae); Population: Eurostat, http://ec.europa.eu/eurostat/data/database/, 2016.4 US: Curve extrapolated from multiple data sources: 2005-2010: The Surveillance Network database–USA as published in Braykov et. al., 2013 (Klebsiella pneumoniae); 2011: Antimicrob Agents Chemother. 2013 Apr;57(4):1982-8. (Klebsiella spp.,

non-susceptibility to meropenem; 2011 data point represents combined data from isolates collected in 2010 and 2011); 2012: ICAAC 2013, poster C2-1630 (Klebsiella pneumoniae, non-susceptibility to meropenem); 2014-2015: JMI Laboratories, surveillance conducted for Achaogen (Klebsiella pneumoniae, non-susceptibility to 1 or more carbapenems: meropenem, imipenem, doripenem).

Carbapenem Resistance in Klebsiella spp.

0%

1%

2%

3%

4%

5%

6%

7%

8%

9%

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Non

susc

eptib

le Is

olat

es

Europe3

US4

0

5

10

15

20

25

30

Community-Acquired Hospital-Associated

% E

SBL+

U.S. Prevalence of ESBL Production in E.coli from Urinary Sources1

2011 2012 2013 2014

UTI Inpatients Receiving a Carbapenem In-Hospital or Upon Discharge, U.S.2

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Patie

nts

Increase in ESBL Prevalence

Increasing Reliance on Carbapenem Therapy

Rise in Carbapenem Resistance


6

Plazomicin has Potent In-vitro Activity Against MDR Enterobacteriaceae, Including ESBL-Producers, CRE Strains and AG-Resistant Isolates

Plazomicin: A Next Generation Aminoglycoside for the Treatment of MDR Enterobacteriaceae

• Discovered at Achaogen; U.S. patent protection currently estimated 2031-2032

AMEs

AMEs AMEs

AMEs

AMEs )

• Uniquely engineered to overcome aminoglycoside-modifying enzymes (AME) that inactivate existing aminoglycosides

• AMEs co-travel with other resistance mechanisms, including β-lactamases and carbapenemases

• Rapidly bactericidalAdapted from Aggen JB, et al. Antimicrob Agents Chemother. Figure 1.


77

Plazomicin Clinical Trial Results

8

88.0%81.7%

91.4%

70.1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Day 5 Composite Cure(mMITT)

TOC Composite Cure(mMITT)

Com

posi

te C

ure

Positive Efficacy Results in EPIC Phase 3 Trial in cUTI/APPlazomicin demonstrated non-inferiority on FDA endpoint and statistical superiority to meropenem on EMA endpoints

* lower bound of the CI exceeds zero indicating statistical superiorityTOC: Test-of-Cure visitComposite Cure includes microbiological eradication and clinical cure

% Difference [Plazomicin minus Meropenem] (95% CI)

Day 5: -3.4 (-10.0, 3.1) TOC (Day ~17): 11.6 (2.7, 20.3)*

87.4% 90.5%

72.1%76.6%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

TOC Micro Eradication(mMITT)

TOC Micro Eradication(ME-TOC)

Mic

robi

logi

cal E

radi

catio

n

mMITT: 15.4 (7.5, 23.2)* ME: 13.9 (6.3, 21.7)*

Plazomicin

Meropenem

FDA Endpoint EMA Endpoint


168/191 180/197 156/191 138/197 167/191 142/197 162/179 134/175

9

1.8% 0%

7.9%

21.1%

0

10

20

30

All clinical cures at TOC Subgroup with asymptomaticbacteriuria at TOC

89.5%84.3%

74.6%

65%

0

20

40

60

80

100

TOC LFU

* Lower bound of the CI exceeds zero. Microbiological eradication defined as baseline uropathogen reduced to <104 CFU/mL.TOC, test of cure 15-19 days from 1st dose IV study drug; LFU, late follow-up 24-32 days from 1st dose IV study drug.

Clinical Relapse at LFU in Patients Who Were Clinical Cures at TOC (mMITT).Clinical relapse: worsening relative to baseline, new symptom relative to baseline, or no return to pre-morbid status of any core symptoms of cUTI. Asymptomatic bacteriuria at TOC defined as clinical cure at TOC together with microbiological persistence at TOC (baseline uropathogen(s) ≥104 CFU/mL).

EPIC Efficacy ResultsPlazomicin demonstrated significantly higher eradication rates at TOC and LFU and lower relapse rate at LFU

171/191 147/197 161/191

Mic

robi

olog

ical

era

dica

tion

(%)

128/197

14.9 (7.0 to 22.7)* 19.3 (10.4 to 27.9)*

Plazomicin

Meropenem

3/170 14/178 0/12 8/38

Clin

ical

rela

pse

at L

FU (%

)

Significantly Higher Microbiological Eradication Lower Clinical Relapse


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EPIC Clinical Trial AE Summary and Renal Function Laboratory Parameters

TEAE: Treatment Emergent Adverse Event; SAE: Serious Adverse Event

Patients with Any of the Following:(Safety Population)

Plazomicin(N=303), n (%)

Meropenem(N=301), n (%)

TEAE 59 (19.5) 65 (21.6)IV Study Drug Related 18 (5.9) 16 (5.3)

Led to Discontinuation of IV Study Drug 6 (2.0) 6 (2.0)

Related to Renal Function 11 (3.6) 4 (1.3)

SAE 5 (1.7) 5 (1.7)IV Study Drug Related 1 (0.3) 1 (0.3)

Death 1 (0.3) 0 (0.0)


Serum Creatinine (Safety Population) Plazomicinn/N (%)

Meropenemn/N (%)

≥0.5 mg/dL increase any time on study (including on and/or post IV therapy) 21/300 (7.0) 12/297 (4.0)

≥0.5 mg/dL increase while on IV therapy 11/300 (3.7) 9/297 (3.0)

Full recovery at last follow-up visit 9/11 9/9 Full recovery defined as serum creatinine value <0.5 mg/dL above the baseline value at the EOIV visit or last post-baseline measurement, respectively

Changes to renal function were limited and reversible

11

CARE Primary Results (Not FDA Approved)

Difference [Plazomicin minus Colistin] (90% CI)Results: Lower values are better

0

10

20

30

40

50

60

Patie

nts

(%)

-26.5% (-51.2 to 0.7%)

-28.2% (-52.5 to -0.7%)

23.5%

11.8%

Day 28 all-cause mortality or significant disease related

complications

Day 28 all-cause mortality

50.0%

40.0%

Colistin (N=20)

Plazomicin (N=17)

Cohort 1 mMITT Population

Two-sided 90% confidence interval (CI) calculation based on the unconditional extact method


12

CARE Kaplan-Meier Survival Curve (Not FDA Approved)

SurvivalProbability

Time to Event (Days)

1.0

0.8

0.6

0.4

0.2

0.0

0 10 20 30 40 50 60

Plazomicin (N=17)

Colistin (N=20)

Censored

Plazomicin:ColistinThrough Day 28: HR (90% CI): 0.25 (0.07, 0.93): p=0.03Through Day 60: HR (90% CI): 0.47 (0.22, 1.02): p=0.05

Estimate of hazard ratio (HR) calculated as plazomicin:colistin based on Cox proportional hazards regression model. Data from Cohort 1 (mMITT)


13

CARE Overall Summary of TEAEs and SAEs

• Reduced drug-related AEs, SAEs, and AEs related to renal function in plazomicin group • No study drug-related deaths or events of ototoxicity reported

Safety Population

Plazomicin(N=18)n (%)

Colistin(N=21)n (%)

TEAE 16 (88.9) 21 (100.0)Study Drug-related 5 (27.8) 9 (42.9)

Led to Discontinuation of Study Drug 2 (11.1) 1 (4.8)

SAE 9 (50.0) 17 (81.0)IV Study Drug-Related 1 (5.6) 4 (19.0)

TEAEs Related to Renal FunctionOverall Pooled 6 (33.3) 11 (52.4)

Study Drug Related 3 (16.7) 8 (38.1)

SAE, serious adverse event; TEAE, treatment-emergent adverse event


14

FDA Actions Related to Plazomicin on June 25, 2018

CARE Clinical Trial

• Complete Response Letter (CRL) by the FDA for bloodstream infection

• Company seeking BSI indication though Formal Dispute Resolution Request (FDRR) filed December 2018.

EPIC Clinical Trial

Supported approval in patients for treatment of cUTI, including pyelonephritis, who have limited or no alternative treatment options


15

Response Submitted Feb ‘19 to ASPR/BARDA Request for Information for Antimicrobial Resistance Project BioShield

• RFI requesting capabilities for procuring, stockpiling and investing in ongoing development of FDA approved antibiotic products for treatment of biodefense indications, for which plazomicin has demonstrated preclinical efficacy

• Should RFI progress to Request for Proposal (RFP), believe ZEMDRI could play a significant role in biodefense preparedness

1616

ZEMDRI Market Opportunity & Launch Update

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Hospital-Treated Patients

The ZEMDRI launch is focused on the

1M+ patients with recurrent cUTI, MDR cUTI, and CRE

Recurrent cUTI2

cUTI1

MDR cUTI1,3

CRE1,3 1M+ patients

(1) Decision Resources Epidemiology 2017 (2) AKAO quantitative market research study with 200 target physicians, June 2017; (3) TSN Surveillance Network and company internal analysis

90K

600K

450K

3M

1M+ Patients Treated in the U.S. Inpatient Setting for Multi-Drug Resistant or Recurrent cUTI

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MDR cUTI Often Treated Outpatient

More than 50% of cUTI patients with MDR infections receive IV antibiotic treatment in an outpatient site of care

~50% inpatient treatment only

~35% inpatient followed by continued outpatient treatment

~15% full outpatient treatment


AKAO quantitative market research study with 140 target physicians and pharmacist, Dec 2018

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Key Dates for ZEMDRI US Commercial Launch

ZEMDRI (plazomicin), a Once-Daily Aminoglycoside for use in complicated Urinary Tract Infections (cUTI)

• FDA Approved on June 26th 2018• Launched in the U.S. on July 20th 2018• Granted NTAP1 designation on August 3, 2018 and

effective October 1st 2018• Granted Permanent C-Code January 20191New Technology Add-on Payment


20

ZEMDRI Commercial Effort Focused on Geographies with Large Outpatient Opportunity and High Volume Hospitals

Current Field Team Focus

– Focused field-based team located in high volume territories

– 75% of current sales are outpatient

– Major outpatient accounts are concentrated in a few key geographies

– Cover key national accounts based on volume and opportunity

– Invest in territories with highest potential for near-term volume

Outpatient

Hospital AvoidanceTransition of Care

Strategic Fit• Addresses specific patient challenge of recurrent

and MDR cUTI• Strong fit for outpatient practice operations

– Short 1x daily 30 minute infusion – Stable 24 hours at room temperature and 7 days in an IV bag

• Not subject to formulary review process• ASP+ reimbursement dynamic


21

ZEMDRI Leading Indicator Metrics

Number of hospital formulary approvals to date (98% formulary approval rate)

Number of major hospital systems included in formulary approvals

75% current sales is to the outpatient setting

Number of physician owned infusion centers who have requested or are under contract

The ZEMDRI launch has built a solid foundation to support product utilization

155 6


200+

2222

Pipeline: C-Scape

23

C-Scape Executive Summary

• Oral antibiotic to treat infections due to ESBL- producing Enterobacteriaceae- WHO: Critical Priority 1 Pathogen- CDC: Serious Public Health Threat

• Higher probability of clinical/regulatory success given history of individual components- Compelling commercial opportunity based on at least 8 years of US exclusivity

• Initial Phase 1 results positive; additional development underway, including a planned Phase 1 clinical pharmacology trial in 2019 followed by a single Phase 3 trial in cUTI

• Combination of previously approved compounds (ceftibuten + clavulanate), potent activity against ESBL- producing isolates- Awarded QIDP status; eligible for streamlined development

High Unmet Need

Innovative Oral Antibacterial

Attractive Risk Profile

Development Underway

24MIC >2 MIC 1-2 MIC <1 JMI Laboratories, Inc. – Achaogen Data on FileMIC, minimal inhibitory concentration

C-Scape is a Uniquely Potent β-lactam / β-lactamase Inhibitor Combination of Ceftibuten and Clavulanate

C-Scape combination of ceftibuten and clavulanate demonstrated higher potency and favorable PK properties compared to all other oral cephalosporins evaluated

Organism ESBL Enzyme Amoxicillin-ClavulanateMIC (µg/mL)

CiprofloxacinMIC (µg/mL)

C-ScapeMIC (µg/mL)

E. coli CTX-M-15,TEM-1 16 ≤0.03 0.5

E. coli CTX-M-15,TEM-1 8 >4 0.5

E. coli CTX-M-14 8 ≤0.03 0.5

K. pneumoniae SHV-5,TEM-1 8 0.25 0.12

K. pneumoniae SHV WT,CTX-M-15, OXA-1/30-like 16 1 0.5

K. pneumoniae SHV-11,SHV-12,TEM-1 8 >4 0.25

K. pneumoniae SHV-30 8 0.12 0.25

P. mirabilis CTX-M-15-like,TEM WT 2 ≤0.03 0.03

P. mirabilis CTX-M-14-like,TEM WT 8 4 0.03

P. mirabilis None 0.5 >4 <0.015

P. mirabilis None 1 ≤0.03 <0.015

E. coli None 8 >4 0.25

K. pneumoniae None 2 >4 0.06

2525

Corporate Profile

26

Corporate Restructuring and Review of Strategic Alternatives

• Implemented a restructuring that reduces ongoing cash operating expenses to $15-17 million per quarter starting Q2 2019 to preserve cash resources

• Continued review of strategic alternatives to maximize shareholder value including but not limited to potential sale or merger of the Company or its assets

• Evercore retained as an independent financial advisor

• Maintained focus on (a) commercializing ZEMDRI primarily in the outpatient setting and certain key geographies, (b) developing C-Scape, (c) pursuing non-dilutive funding opportunities and (d) pursuing licensing partnerships and regulatory approvals for plazomicin outside the United States

27

Financial Snapshot

• $31.0 million in unrestricted cash, cash equivalents, short-term investments as of 12/31/18*

• $25.5 million in restricted cash as of 12/31/18*• Raised ~$13.6 million in net proceeds through equity public offering in Feb 2019• $25 million second tranche drawn down from Silicon Valley Bank in Oct 2018; total

current debt of $50 million of which $25 million is restricted• Funding partnerships

– BARDA non-dilutive funding: $124.4 million (plazomicin)– BARDA non-dilutive funding: up to $18 million (C-Scape)– CARB-X non-dilutive funding: up to $12 million (novel aminoglycoside)**

* Preliminary and unaudited** Program deprioritized

28

Achaogen Has Built a Strong Foundation for ZEMDRI Sales in the U.S., Geographic Expansion and Further Pipeline Development

U.S. ZEMDRI (plazomicin) Approval

ZEMDRI Commercial Launch

Plazomicin MAA Submission

NTAP Approval Granted for ZEMDRI

Thermo Fisher Scientific TDM Approval

Formulary Review Progress

Successful Completion

□ ZEMDRI Revenue Catalysts□ New England Journal of Medicine Publications□ C-Code Designation □ Positive Formulary Reviews □ Hospital Avoidance Pilot Readout□ J-Code Designation

□ Corporate Catalysts□ BARDA RFI Response for Project BioShield□ E.U. Plazomicin MAA progress□ Ex-US Commercial Plazomicin Partnership□ BSI Dispute Resolution Process□ C-Scape: Phase 1 Trial□ Economic Incentives Advancement

Planned / Upcoming

Significant ProgressStrong Execution2018 2019 Milestones with Potential to

Drive Value

AKAO Corporate Presentation - Seeking Alpha

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