unlocking the potential of today’s medicines for profound ... · this presentation may contain...

Xeris Pharmaceuticals, Inc. ©2017-2019 All Rights Reserved

Unlocking the potential of today’s medicines for profound impact

November 2019


Forward-looking Statements

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This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the acceptance of Gvoke™ in the marketplace, the market and the therapeutic potential of our product candidates, expectations regarding clinical data, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing or likelihood of expansion into additional markets, expectations regarding the timing of the commercial launch of Gvoke HypoPen™, and the potential utility of our formulation platforms. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our launch and commercialization plans, our clinical results and other future conditions. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” and other similar expressions are intended to identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

These statements are also subject to a number of material risks and uncertainties that are discussed in the section entitled “Risk Factors” section of Xeris’ most recently filed Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any forward-looking statement hereinspeaks only as of the date on which it was made. Neither we, nor our affiliates, advisors, or representatives undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.


Xeris Overview

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Differentiated Technology

Attractive Market

Opportunities

Proven Business Model

Experienced Leadership

Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations


Xeris Executive Team

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Paul Edick

Chairman and Chief Executive Officer

40 years in healthcare industry: Durata Therapeutics, MedPointe, Pharmacia, Searle, Baxter, Johnson & Johnson

John Shannon

Chief Operating Officer

33 years in healthcare industry: Catheter Connections, Durata Therapeutics, Baxter, Searle

Steve Prestrelski, Ph.D., MBA

Chief Scientific Officer

27 years in healthcare industry: Xeris Scientific Founder, Amylin, PowderJect, Alza

Barry Deutsch

Chief Financial Officer

28 years in healthcare industry: Shire, Baxalta, Baxter, Ovation Pharmaceuticals, Vector Securities, Salomon Brothers

Ken Johnson, Pharm.D.

SVP, Clinical Development, Regulatory, Quality Assurance and Medical Affairs

26 years in healthcare industry: Merck, Durata Therapeutics, Horizon Pharma, Takeda, Searle, Bristol-Myers Squibb

Beth Hecht

General Counsel and Corporate Secretary

25 years in healthcare industry: Auven Therapeutics, Durata Therapeutics, Sun Products, MedPointe, Warner Chilcott, ChiRex, Alpharma

Allison Wey

SVP, Investor Relations & Corporate Communications

30 years in healthcare industry and Wallstreet: Durata Therapeutics, Regulus, Par, Boron LePore, Bear Stearns

Kevin McCulloch

SVP, Global Operations and Business Development

30 years in the healthcare industry: Hill-Rom, Water Street Partners, Baxter, Searle, Upjohn


Xeris has two formulation platforms designed to address challenges encountered in development of aqueous formulations

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Drug Class XeriSol™ XeriJect™

Small Molecule

Peptide

mAb

Enzyme

Fusion Protein

Pegylated Protein

Antibody Drug Conjugate

Oncolytic Immunotherapy

High Spectrum Applicability

Key Xeris formulation attributes enable development of patient-friendly injectables• Ready-to-use• Room-temperature stability• Highly concentrated formulations• Co-delivery/Co-formulation

Target Molecules:small molecules and peptides

Goal: creating room-temperature stable, ready-to-use injectable liquid solutions

Target Molecules:mAbs and biologics

Goal: creating small volume, non-aqueous suspensions ofdry powders (pastes)

XeriSol™ XeriJect™


Strong intellectual property

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IP STRATEGY

Xeris’ strategy as a platform company is to patent early and often to continue to strengthen our position in the non-aqueous formulation space. Castle/moat approach has led to numerous filings both at the platform and product levels.

PATENT COUNT

• 109 total patents globally, of which 13 are U.S. issued

• 68 patent applications pending globally, of which 13 are pending in the U.S.

• All patents are owned by Xeris• Glucagon protection out to 2036

NON-AQUEOUS FORMULATION

SPACE

XeriSolTM

for Peptides

XeriSolTM

for Small Molecules

XeriJectTM

Cont 1Ultra-Rapid

Acting Insulin XeriSolTM

GlucagonBioavail.

XeriJectTM

Base

XeriSolTM

Diazepam= Issued/Allowed

XeriSolTM

Glucagon(method of

use)

XeriJectTM

Cont 2

Low-DoseGlucagon for

Weight Control

XeriSolTM

Glucagon DSP(composition of

matter)

XeriSolTM

Glucagon (method of

making)

XeriSolTM

Glucagon(method of

administration)

XeriSolTM

Glucagon (composition of

matter)


Four strategic imperatives across the portfolio

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Develop additional

ready-to-use products

Expand ready-to-use

glucagon portfolio

Leverage technology

out-licensing opportunities

Primary focus on Glucagon Rescue Product


NOW APPROVED! GvokeTM PFS and Gvoke HypoPenTM


NOW APPROVED! GvokeTM PFS and Gvoke HypoPenTM

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The first ever liquid glucagon

Premixed

Prefilled

Premeasured

Gvoke Pre-Filled Syringe

Now Available

Gvoke HypoPen

Launch Expected July 2020


Glucagon is used to treat severe low blood sugar

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1. ADA Standards of Medical Care in Diabetes. Glycemic Targets. Diabetes Care, 20192

2. International Hypoglycaemia Study Group. Diabetes Care 2017;40:155–57.

Blo

od

su

ga

r

Time

Low

Blood Sugar

Really Low

Blood Sugar

Severely Low

Blood Sugar

Mild

Hypoglycemia 54-70 mg/dL

Level 1

Moderate

Hypoglycemia <54 mg/dL

Level 2

Severe

HypoglycemiaNo specific threshold

Level 3

Real-world Perspective

15:15

Rule

Administer

Glucagon

Clinical Recommendation


Severe low blood sugar occurs in both people with T1D and T2D on insulin

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T1D Experiencing 1-3Severe Lows per Year

~30-40%

1. McCrimmon RJ, Sherwin RS. Diabetes. 2010 Oct;59(10):2333-2339.2. Edridge CL, Dunkley AJ, Bodicoat DH, Rose TC, Gray LJ, Davies MJ, Khunti K. PLoS One. 2015 Jun 10;10(6):e0126427.

T2D on Insulin Experiencing Severe Low per Year

~20%


- 1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000

Prevalence of Insulin-Treated, Medically Reasonable Candidates for Glucagon

Glucagon is currently underutilized

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Sources: 1Dall et al 2016, 2IMS NPA Jul 2016 MAT

Insulin-Treated DM (All T1D + ~23% T2D)1

T24.3M

0.66M

Actual Glucagon Rx2

5.6

0.66

Population (M)

Gap between potential need and

actual Rx

GAP

T11.3M


Speed of adoption will be influenced by patient attitudes and beliefs

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Have glucagon today DON’T have glucagon today

Experienced Severe

Hypoglycemia Previously

Concerned and Prepared

Concerned but rather call

9-1-1

Confident“It Won’t

Happen to Me”

Increase Market PenetrationConvert Market

Drive awareness of Xeris Rescue Pen

Elevate importance of being prepared


Glucagon market opportunity is under penetrated

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Market Opportunity Parameters

SourcesCurrent U.S.

MarketU.S. Market

Need

Type 1/2 drug-treated DM Datamonitor, Epidemiology: Type 1 and Type 2 Diabetes Forecast 2015-2035 20.2M(18.9M T2 + 1.3M T1)

20.2M(18.9M T2 + 1.3M T1)

Type 1/2 insulin-treated DM

Datamonitor, Epidemiology: Type 1 and Type 2 Diabetes Forecast 2015-2035

CDC 2010–2012 National Health Interview Survey: ~23% of diagnosed-drug-treated T2DM take insulin +/- other (factored for T1DM)

5.6M(4.3M T2 + 1.3M T1)

5.6M(4.3M T2 + 1.3M T1)

Type 1/2 insulin-treated medically reasonable

candidates for glucagon

All Insulins carry a Hypoglycemia Warning in PI ADA 2017 Diabetes Guidelines:

Glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia defined as blood glucose <54 mg/dL (3.0 mmol/L)

We believe all T1 and 50% of T2 on insulin are medically reasonable candidates

~662K filled prescriptions

3.5M patients(2.2M T2 + 1.3M T1)

Unit volumeCurrent kit volume ~978K/yr, ~662K TRx (IQVIA, LTM Q318)Symphony, 2017 suggests > 1 kit/ptXeris market research suggests up to 3/pt at peak on average

978K Kits(~662K TRx or 1.5 kits/TRx)

7.0M Units(2 units/pt)

Price per unit Analysource Pricing Database 2018, Lilly GEK and HypoKit list WAC is $281* in Feb 2019 $280 $280

U.S. Market Opportunity Current U.S. Market - IQVIA 2018 reported sales NSPU.S. Market Need Units sold times price per unit ~$246M ~$2B

*rounded to nearest 0


Drive awareness with clinicians and activate patients to ask for Xeris Gvoke™

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• Engage with professional associations

− Endo associations (ADA, AACE, ACE, etc.)

− CDE associations (AADE, NCBDE, etc.)

− Internal Med associations (ACP, etc.)

• Prelaunch - Activate advocacy groups as

messengers to reach patients/caregivers

− JDRF

− Children with Diabetes (CWD)

− Beyond Type 1

− College Diabetes Network (CDN)

− Taking Control of Your Diabetes (TCOYD)

− diaTribe

− Type 1 Diabetes Exchange (T1DEx)

• Comprehensive, targeted reach to drive GEK conversion and expand glucagon adoption

― 60 sales reps covering CDEs and HCPs writing >70% of current glucagon business

― Supported by a team of 10 Medical Affairs Directors― Supported by a National Accounts team ensuring broad

access to Gvoke

• Leverage non-personal channels such as:

− Direct-to-Consumer advertising

− Press coverage

− Social media

− Digital presence

− Traditional off-line channels

Field ForceNon-

Personal

Patient Advocacy

GroupsAssociations

Activate PatientsTarget Clinicians


Robust Pipeline of Ready-to-Use Products and Indications


Xeris has a robust pipeline across its ready-to-use portfolios

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Product Candidate

Indication Development Stage Next Milestone

Preclinical Phase 1 Phase 2 Phase 3 Marketed EventExpected

Date

Gvoke™ Severe Hypoglycemia Launch HypoPen 2H ‘20

Glucagon PFS/AI - EU Severe Hypoglycemia Approval 1H ‘21

Self-Administered Glucagon

Post-Bariatric Hypoglycemia*

Ph 2 in-clinic data 2H ’19

Self-Administered Glucagon

Exercise-Induced Hypoglycemia

Ph 2 in-clinic data 2H’19

Continuous Subcutaneous Glucagon

Hypoglycemia-Associated Autonomic Failure

Ph 2 Treatment Results

2H ’19

Pramlintide-Insulin T1D / T2D Blood Sugar Control

Ph 2 data 1H ‘20

DiazepamAcute Repetitive Seizures*Dravet Syndrome*

Ph 1b data 1H ‘20

Phase 2

Phase 2

Phase 2

Phase 1b

Rea

dy-

to-U

se

Pro

du

cts

for

Epile

psy

an

d

Dia

bet

es

Rea

dy-

to-U

se G

luca

gon

fo

r H

ypo

glyc

emia

* Orphan Drug Designation

Continuous infusion glucagon for Congenital Hyperinsulinism* via Expanded Access

Phase 2


Application of ready-to-use glucagon for additional conditions associated with hypoglycemia

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Ready-to-use, room-temperature stable liquid glucagon formulation enables

development for multiple hypoglycemic indications

• Post-Bariatric Hypoglycemia (PBH)

• Received Orphan Drug Designation in severe population

• Ready-to-use vial and open- or closed-loop pumps

• US patient population: ~85K

• Exercise-induced Hypoglycemia (EIH)

• Phase 2 in-clinic results 2H19

• Mini-dose of glucagon (MDG)

• US patient population: subset of those on insulin who exercise regularly

• Congenital Hyperinsulinism (CHI)

• Expanded Access at no cost to eligible patients

• Received Orphan Drug Designation in US & EU

• Continuous Subcutaneous Infusion (CSI) glucagon

• US patient population: ~6,200

• Hypoglycemia-Associated Autonomic Failure (HAAF)

• Phase 2 trial treatment results lead to discontinuation of the program

• Continuous Subcutaneous Infusion (CSI) glucagon

• US patient population: ~430K

• Glucagon component of bi-hormonal artificial pancreas


Diazepam Clinical Program

Next steps:

• Additional evaluation of human PK

data (modeling)

• Initiate a weight-based dosing study

Phase 1 Top-line results, compared to

Diastat®:

• First use of Xeris’ formulation

technology through IM route

• Safe and well tolerated (IM & SC)

• Higher exposure AUC (IM & SC)

• Similar Cmax (IM)

• Similar Tmax (IM)


Pramlintide-Insulin co-formulation represents a potential advancement in the meal-time insulin market

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• Product Profile

− Co-formulation (single injection) insulin and pramlintide

− Prandial meal-time use

− Multi-dose auto-injector, ready-to-use vial and syringe

• Product Benefits

− Reduction in number of injections (3 vs. 6) relative to co-administration

− Same benefits of pramlintide co-administration with insulin

• Reduction in HbA1c

• Reduced meal-time insulin dose requirement

• Increased time in glycemic range, improved post-prandial glucose control

• Increased weight loss

− Potential improved patient-reported outcomes

• Program Assumptions

− BLA pathway

− Phase 3 pivotal clinical program anticipated

• Target U.S. Patient Population: up to 500k*

* Source: *Xeris-commissioned primary market research Q1 2018 (qual/quant n=20 HCPs; qual n=2 payers); **DataMonitor epidemiology forecast for diabetes


Business Partnering Opportunities


Technology Platform Collaborations (“TPCs”)

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• Increasing interest as drug development

companies seek higher drug concentrations and

drug combinations in subcutaneous formulations

• XeriJect: Monoclonal antibodies and large molecules

• XeriSol: Small molecules and peptides

• Gvoke approval has resulted in increased interest

in XeriSol platform

• Active projects are with Top 10 pharma

companies

• Multiple additional projects under discussion

with both large pharma and specialized biotech

Apply Xeris technology platforms to other companies’ proprietary drugs

TPCs are self-funded and partner resourced

Potential for project milestone payments and royalty stream

Industry visibility for Xeris


Xeris value proposition summary

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Specialty pharmaceutical enterprise with two unique and broadly applicable formulation technologies

Several near-term catalysts including recent launch of Gvoke™ PFS for severe hypoglycemia

Leadership position in ‘ready-to-use’ glucagon for multiple hypoglycemia indications

Pipeline of innovative and valuable follow-on indications and product candidates

Strong patent protection through 2036

Experienced leadership team and strong balance sheet

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