UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________________________
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 2018
_______________________________
XERIS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
______________________________
Delaware | 001-38536 | 20-3352427 | ||||
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) | ||||
180 N. LaSalle Street, Suite 1810 Chicago, Illinois 60601 (Address of principal executive offices, including zip code) | ||||||
(844) 445-5704 | ||||||
(Registrant's telephone number, including area code) | ||||||
Not Applicable | ||||||
(Former name or former address, if changed since last report) | ||||||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||||||||
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||||
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||||
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||||
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||||
Indicate by check mark whether the registrant is an emerging growth company is defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12-2 of this chapter). | ||||||||
Emerging growth company þ | ||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨ | ||||||||
Item 7.01 Regulation FD Disclosure
Xeris Pharmaceuticals, Inc. (the “Company”) is furnishing an investor presentation, attached as Exhibit 99.1 to this Current Report on Form 8-K, which the Company intends to use from time to time in meetings with investors and others. The investor presentation will also be available on the Company’s website at www.xerispharma.com. The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits:
The following exhibit relating to Item 7.01 shall be deemed furnished, and not filed:
Exhibit No. | Description |
99.1 | Xeris Pharmaceuticals, Inc. Investor Presentation August 2018. |
EXHIBIT INDEX
Exhibit No. | Description |
99.1 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Xeris Pharmaceuticals, Inc. | ||||
Date: August 7, 2018 | /s/ Barry M. Deutsch | |||
Barry M. Deutsch | ||||
Chief Financial Officer | ||||
Exhibit 99.1 Enabling Solutions for Injectable Therapeutics August 2018 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Forward-looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the therapeutic potential of our product candidates and the potential utility of our formulation platform technologies. 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” in the final prospectus related to Xeris’ initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act, 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 herein speaks 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. 2 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Xeris overview Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations Experienced Differentiated Leadership Technology Attractive Proven Market Business Model Opportunities 3 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Xeris executive team and investors Paul Edick John Shannon Chairman and Chief Executive Officer Chief Operating Officer 40 years in healthcare industry: 33 years in healthcare industry: Catheter Durata Therapeutics, MedPointe, Connections, Durata Therapeutics, Baxter, Pharmacia, Searle, Baxter, Johnson & Searle Johnson Allison Wey Beth Hecht SVP, Investor Relations & Corporate General Counsel and Corporate Secretary Communications 25 years in healthcare industry: Auven 30 years in healthcare industry and Therapeutics, Durata Therapeutics, Sun Wallstreet: Durata Therapeutics, Regulus, Products, MedPointe, Warner Chilcott, Par, Boron LePore, Bear Stearns ChiRex, Alpharma Steve Prestrelski, Ph.D., MBA Barry Deutsch Chief Scientific Officer Chief Financial Officer 27 years in healthcare industry: Xeris 28 years in healthcare industry: Shire, Scientific Founder, Amylin, PowderJect, Baxalta, Baxter, Ovation Pharmaceuticals, Alza Vector Securities, Salomon Brothers Ken Johnson, Pharm.D. Sr VP, Clinical Development, Regulatory, Quality Assurance and Medical Affairs 26 years in healthcare industry: Merck, Durata Therapeutics, Horizon Pharma, Takeda, Searle, Bristol-Myers Squibb 4 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Xeris has two formulation platforms designed to address challenges encountered in development of aqueous formulations XeriSol™ XeriJect™ Target Molecules: Target Molecules: small molecules and peptides mAbs and biologics Goal: creating room- Goal: creating small volume, temperature stable, ready-to- non-aqueous suspensions of use injectable liquid solutions dry powders (pastes) High Spectrum Applicability Drug Class XeriSol™ XeriJect™ Small Molecule Peptide Key Xeris formulation attributes enable mAb development of patient-friendly injectables • Ready-to-use Enzyme • Room-temperature stability Fusion Protein • Highly concentrated formulations Pegylated Protein • Co-delivery/Co-formulation Antibody Drug Conjugate Oncolytic Immunotherapy 5 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Strong intellectual property XeriSolTM Glucagon DSP IP STRATEGY (composition of XeriSolTM matter) Glucagon Xeris’ strategy as a platform (method of company is to patent early and often use) to continue to strengthen our XeriSolTM Glucagon position in the non-aqueous (method of formulation space. Castle/moat making) approach has led to numerous filings XeriSolTM both at the platform and product Glucagon XeriSolTM (method of XeriSolTM levels. for Small administration) for Peptides NON-AQUEOUS Molecules Low-Dose FORMULATION Glucagon for SPACE PATENT COUNT Weight Control • 72 total patents globally, of which XeriSolTM XeriJectTM XeriJectTM 13 are U.S. issued Glucagon Base Cont 2 (composition of • 81 patent applications pending matter) globally, of which 13 are pending XeriJectTM Cont 1 in the U.S. Ultra-Rapid TM • All patents are owned by Xeris Acting Insulin XeriSol Glucagon • Glucagon protection out to 2036 Bioavail. XeriSolTM Diazepam = Issued/Allowed 6 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Xeris has a robust pipeline across its ready-to-use portfolios Product Indication Development Stage Next Milestone Candidate Expected Preclinical Phase 1 Phase 2 Phase 3 Event Date Phase 3 Glucagon Rescue Pen Severe Hypoglycemia Submit NDA 3Q ’18 Ph 2a Results 1H ’18 (Closed Loop Self-Administered Post-Bariatric Phase 2a Pump) 2H ’18 Glucagon Hypoglycemia* Initiate Ph 2b (Vial/Syringe) Use Glucagon for GlucagonUse - Congenital Phase 2 Ph 2 Interim to Continuous Glucagon 2H ’18 Hypoglycemia - Hyperinsulinism* Efficacy Results Hypoglycemia- Ready Continuous Glucagon Associated Autonomic Phase 2a Ph 2a Results 1H ’19 Failure Self-Administered Exercise-Induced Phase 2a Initiate Ph 2b 2H ’18 Glucagon Hypoglycemia Use - Acute Repetitive to Preclinic - Diazepam Seizures* al Ph 1 Results 1H ‘19 Diabetes Dravet Syndrome* Products Products for Epilepsy and and Epilepsy Ready T1D / T2D Blood Sugar Preclinic Pramlintide-Insulin Preclinical Results 1H ’18 Control al *Have received Orphan Drug Designation • Additionally, bi-hormonal artificial pancreas program underway • 505(b)(2) pathway being pursued for our product candidates Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Four strategic imperatives across the portfolio Primary focus on Glucagon Rescue Product Expand ready-to-use glucagon portfolio Develop Leverage additional technology ready-to-use out-licensing products opportunities 8 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Risk of hypoglycemia is a daily reality for people with diabetes Range of hypoglycemia Mild Moderate Severe (Level 1) (Level 2) (Level 3) Glycemic Criteria < 70 mg/dL < 54 mg/dL No specific threshold Requires fast-acting carbs and dose Serious, clinically Severe cognitive impairment requiring Description adjustment of glucose-lowering important hypoglycemia external assistance for recovery therapy Glucose Glucagon Treatment or any form of carbohydrate that contains glucose or IV Glucose • Hypoglycemia a daily concern for people with diabetes − T1D experience mild/moderate hypoglycemia 2x a week1 ▪ For 30-40%, glycemic level drops low enough to be severe 1-2x a year − 50% of T2D on insulin experience mild/moderate hypoglycemia 2x a month2 ▪ For ~21%, the glycemic level drops low enough to be severe 1x a year • Fear of hypoglycemia a critical deterrent to diabetes self-management and quality of life − Reaction can vary from increased vigilance to potentially immobilizing distress3 − Many run levels high to avoid hypoglycemic events3 1. McCrimmon et al, Hypoglycemia in Type 1 Diabetes, Diabetes Vol. 59, October 2010; 2. Edridge et al, Prevalence and Incidence of Hypoglycaemia in 532,542 People with Type 2 Diabetes on Oral Therapies and Insulin: A Systematic Review and Meta-Analysis of Population Based Studies, PLOS ONE | DOI:10.1371/journal.pone.0126427 June 10, 2015. 3. Martyn-Nemeth, Fear of hypoglycemia in adults with type 1 diabetes: impact of therapeutic advances and strategies for prevention - a review, Journal of Diabetes and Its Complications 30 (2016) 167–177 9 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
There is an opportunity to both influence percent of patients prescribed glucagon as well as patient refill compliance rates Glucagon Prescription Funnel by Patient Type1 Total Respondents (N=403) Clinicians think ~75% of T1D TYPE 1 and ~50% of T2D on insulin should have glucagon on 70% hand1 31% 62% % ever prescribed drop glucagon 48% off % currently prescribed Two of the most common reasons glucagon people don’t renew glucagon % of patients perceived 2 TYPE 2 to have a filled prescriptions, are glucagon prescription • Their clinician did not ask if 31% they wanted a new kit 25% 42% • Only ~50% are confident in drop someone administering the kit 18% off QA2. For each patient type below, please answer the following: • For what percent have you ever prescribed glucagon? • For what percent do you currently prescribe glucagon? • What percent would you estimate currently has a fully functional, unexpired glucagon emergency kit? QB1. Please indicate how you would prescribe glucagon if only the treatment option below was available Q285. You answered that you do not currently own a glucagon kit but that you have owned one in the past. Why did you stop renewing your glucagon kit? 1. Healthcare Professional Perceptions Study (n=403), LRW, 2018; 2. Patient and Caregivers Perceptions Study (n=700), IPSOS, 2018. 10 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Glucagon rescue market opportunity is under penetrated Current U.S. Market Opportunity U.S. Market Need Sources Market Parameters 2017 2017 Datamonitor, Epidemiology: Type 1 and Type 2 Diabetes Forecast 2015-2035 20.2M 20.2M Type 1/2 drug-treated DM (18.9M T2 + 1.3M T1) (18.9M T2 + 1.3M T1) Datamonitor, Epidemiology: Type 1 and Type 2 Diabetes Forecast 2015-2035 5.6M 5.6M Type 1/2 insulin-treated DM CDC 2010–2012 National Health Interview Survey: ~23% of diagnosed-drug-treated (4.3M T2 + 1.3M T1) (4.3M T2 + 1.3M T1) T2DM take insulin +/- other (factored for T1DM) All Insulins carry a Hypoglycemia Warning in PI → ADA 2017 Diabetes Guidelines: Type 1/2 insulin-treated Glucagon should be prescribed for all individuals at increased risk of clinically ~660K filled 3.5M patients medically reasonable significant hypoglycemia defined as blood glucose <54 mg/dL (3.0 mmol/L) prescriptions (2.2M T2 + 1.3M T1) candidates for glucagon We believe all T1 and 50% of T2 on insulin are medically reasonable candidates Current kit volume ~960K/yr, ~660K TRx (IQVIA, 2017) 960K Kits 7.0M Units Unit volume Symphony, 2017 suggests > 1 kit/pt (~660K TRx or (2 units/pt) Xeris market research suggests up to 3/pt at peak on average 1.5 kits/TRx) Analysource Pricing Database 2017, Lilly GEK list WAC is $281 in 2017 Price per unit Historical GEK list WAC increase at avg. 9% twice per year, and 9%/year in 2016-17 $280 $280 Current U.S. Market 2017 - IQVIA 2017 reported sales U.S. Market Opportunity U.S. Market Need 2017 - Units sold times price per unit ~$240M ~$2B 11 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Epinephrine sales are almost ten-fold that of glucagon Severe Allergic Reaction Severe Hypoglycemia (epinephrine) (glucagon) Clinically Appropriate Patient 5.2M patients1,2 3.5M patients Population* # of Units Sold (2017) ~8.2M pens3 ~960K kits**3 *“Clinically appropriate patient population” in the allergy market is based on those patients who were deemed to have a very likely history of anaphylaxis. This definition required involvement of at least 2 organ systems, including respiratory systems, cardiovascular systems, or both, as well as seeking treatment in the emergency department and feeling their life was in danger **Sales of Eli Lilly Glucagon Emergency Kits and Novo Nordisk GlucaGen 1. Wood, et al, Anaphylaxis in America: The prevalence and characteristics of anaphylaxis in the United States. Journal of Allergy and Clinical Immunology. February, 2014. 2. United States Census Bureau, World Bank (2016); 3. IQVIA, US NSP MAT Dec, 2017. 12 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
We believe Xeris’ Rescue Pen would replace existing Glucagon Emergency Kits and clinicians would prescribe glucagon to more people across all patient types Demand Allocation Exercise with Current Glucagon Emergency Kit (GEK) Only 24% 43% 37% 55% 80% 77% Would Prescribe Current Glucagon Emergency Kit 76% 57% 63% Would NOT Prescribe 46% Available Treatment 20% 23% T1D Peds T1D Adult T2D Basal + Bolus T2D Basal + Sulf T2D Basal T2D NOT2D Insulin. No Insulin Orals + Sulf Orals + Sulf Demand Allocation Exercise with Current GEK and Xeris Rescue Pen (Saw Xeris Rescue Pen: N=202) 12% 21% 22% 19% 17% 15% Would Prescribe Current 23% Glucagon Emergency Kit 32% 38% 49% Would Prescribe Xeris 66% 65% Rescue Pen 65% 53% 45% Would NOT Prescribe Any 33% Available Treatments 13% 13% T1D Peds T1D Adult T2D Basal + Bolus T2D Basal + Sulf T2D Basal T2D NOT2D Insulin. No Insulin Orals + Sulf Orals + Sulf QB1 and QB2. Please indicate how you would prescribe glucagon if only the treatment option below was available Healthcare Professional Perceptions Study (n=403), LRW, 2018. 13 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Patients and caregivers prefer the described features of Xeris’ Rescue Pen and are likely to ask their healthcare provider to prescribe Patient Preference for Described % Likely to ask for a Xeris Rescue Pen Rx1 Features of Xeris Rescue Pen vs 100% 1 Current GEK 99% of clinicians report they 80% 87% would prescribe glucagon if their patient requested it2 60% 68% 24% 63% 54% 40% 76% 20% 0% Definitely/Probably Would Ask Xeris Rescue Pen Current GEKs Total Respondents T1D Caregivers T1D Patients T2D Patients Over 50% of people who DO NOT currently own a kit stated they would ask their healthcare provider for a Xeris Rescue Pen prescription1 Q460. Considering everything you have read about all of the below glucagon products, which one product do you prefer most? What would be your product of choice after your most preferred? Q433. Considering everything you have just read, which statement best describes how you feel about asking a doctor / healthcare provider to prescribe PRODUCT X? BE5. Would you write a prescription for glucagon if the patient or caregiver asked for it? 1. Patient and Caregivers Perceptions Study (n=700), IPSOS, 2018, 2. Healthcare Professional Perceptions Study (n=403), LRW, 2018. 14 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Future competitor analysis • Primary concern with intranasal is absorption of full dose. • Primary concern with Xeris Rescue Pen is it is an injection. However, subcutaneous administration is also associated with perceived efficacy benefits.1 Prescription Barriers: Top 3 Box on a 7-Pt Scale2 Total Respondents (N=403) Q297. Please now put yourself in the place of someone who would be administering a glucagon injection during a severe hypoglycemic event. If they could create the “ideal” glucagon kit based on the descriptors below, how important would each of them be? (% Selecting top 2 box) QC4. How concerning is each aspect of [insert product] 1. Patient and Caregivers Perceptions Study (n=700), IPSOS, 2018, 2. Healthcare Professional Perceptions Study (n=403), LRW, 2018. 15 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Diabetes population is concentrated. Ten states ( ) account for almost 60% of national diabetes patients National Distribution of Diabetes Patients1 % Adult Diabetes Patients (National) • Although rankings differ slightly, the same states are included in the top ten for both T1D and T2D patients • Certified Diabetes Educator (CDE) concentration mirrors that of diabetes population2 − 50% of CDE concentration overlaps in 9 of the 10 top states with the diabetes population % of Total Diabetes Population 16% • Additionally, TX, FL, PA, OH, GA, and NC all demonstrate above average concentrations of diabetes patients (T1D and T2D combined) per capita 1. MMIT Formulary Analytics – June 2017; epidemiology & census data on file 2. https://www.ncbde.org/assets/1/7/StateCount0317.pdf/ Accessed Feb 16, 2018 16 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Drive awareness with clinicians and activate patients to ask for Xeris Glucagon Rescue Pen • 10 Regional Medical Affairs Directors • Leverage non-personal channels such as: • Targeting 60 sales reps − Direct-to-Consumer advertising • Target 8,000 clinicians − Press coverage ― Replace current GEKs: 3,000 clinicians who write − Social media 50% of current glucagon Rxs Digital presence ― Increase penetration: 5,000 high meal-time insulin − prescribers who under-prescribe glucagon − Traditional off-line channels • CDE in-service blitz at launch • Prioritize 10-13 key states Non- Field Force Personal Target Clinicians Activate Patients Patient • Engage with professional associations Associations Advocacy • Prelaunch - Activate advocacy groups as − Endo associations (ADA, AACE, ACE, etc.) Groups messengers to reach patients/caregivers − CDE associations (AADE, NCBDE, etc.) − JDRF − Internal Med associations (ACP, etc.) − T1D Exchange − CDN − TCOYD − CDC/NDEP − Diabetes Advocacy Alliance (DAA) 17 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Current GEKs have favorable market access Glucagon Rescue Kit Formulary Status 100% • Both currently marketed GEKs have high levels of unrestricted access in the 90% Commercial channel 80% − Lilly Glucagon - 97% 70% − Novo Glucagon – 92% 60% 50% • Novo Glucagon has relatively higher 40% Medicare coverage while Lilly has relatively higher Managed Medicaid 30% coverage 20% − Medicare: Novo 97% vs. Lilly 79% 10% unrestricted 0% − Managed Medicaid: Lilly 93% vs. Novo 71% • Both Glucagon Rescue Kits have high levels of unrestricted access in the State Medicaid channel − Lilly Glucagon: 95% − Novo Glucagon: 92% Preferred Covered PA/ST Not Covered • Current trends indicate relatively low- PA/ST = Prior Authorization/Step Therapy Required level of payor management of this category MMIT Formulary Analytics www.formularylookup.com as of Mar 29, 2018 18 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Application of ready-to-use glucagon for additional conditions associated with hypoglycemia Ready-to-use, room-temperature stable liquid glucagon formulation enables development for multiple hypoglycemic indications • Post-Bariatric Hypoglycemia (PBH) − NIH-sponsored Phase 2a Proof-of-Concept (POC) trial at Joslin Diabetes Center − Received Orphan Drug Designation in severe population − Ready-to-use vial and open- or closed-loop pumps − US patient population: ~30K • Congenital Hyperinsulinism (CHI) − NIH-sponsored Phase 2 POC trial ongoing − Received Orphan Drug Designation in US & EU − Continuous Subcutaneous Infusion (CSI) glucagon − US patient population: ~6,200 • Hypoglycemia-Associated Autonomic Failure (HAAF) − Phase 2a POC trial results in 1H 2019 − CSI glucagon − US patient population: ~430K • Exercise-induced Hypoglycemia (self-administration) − Helmsley-sponsored Phase 2a POC results published in Diabetes Care − Mini-dose of glucagon (MDG) − US patient population: subset of those on insulin who exercise regularly • Glucagon component of bi-hormonal artificial pancreas 19 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Dual-Hormone Closed-Loop System and Xeris • Jessica Castle, MD / Oregon Health and Science University (OHSU) − Funded by JDRF − Xeris provides glucagon • A Randomized, Three-way, Cross-over Study to Assess the Efficacy of a Dual-hormone Closed-loop System With XeriSol™ Glucagon vs Closed-loop System With Insulin Only vs a Predictive Low Glucose Suspend System (NCT03424044) • Subjects undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller − Insulin and glucagon delivery: Omnipod (Insulet Corp) − CGM: Dexcom G5 • Primary endpoint: % of time with sensed glucose < 70 mg/dl • Target enrollment N=19 subjects − 8 screened to date − 5 randomized for dosing ➢ 3 subjects have completed dual-hormone Xeris glucagon arm • Estimated completion date: 1H 2019 20 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Ready-to-Use Products for Epilepsy and Diabetes Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Diazepam presentation as rectal gel for refractory epilepsy is suboptimal • Diastat® (diazepam rectal gel) − Effective when administered properly − Can be given in outpatient setting − AcuDial™ system offers dosing flexibility − Delivery issues: • 13-step administration • Leakage, tip breakage • Dose expulsion • Discomfort • Socially problematic − Market research suggests product underutilized due to route of administration • Xeris’ diazepam rescue product addresses Diastat challenges − Auto-injector is a patient-friendly alternative to rectal administration − Easy-to-use − Low-volume injection, small needle − No refrigeration necessary 22 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Pramlintide-Insulin co-formulation represents a potential advancement in the meal-time insulin market • 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 removal of blackbox hypoglycemia warning − Potential improved patient-reported outcomes • Program Assumptions − 505(b)(2) development pathway − Phase 3 pivotal clinical program anticipated • Target U.S. Patient Population: 350-390K 23 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Xerisol Pramlintide-Insulin Efficacy in Diabetic Rat Model Combination of single injection XeriSol™ products show similar efficacy to combination two injection dosing of commercial Symlin and insulin products Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Business Partnering Opportunities Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Technology Platform Collaborations (“TPCs”) Apply Xeris technology platforms to other companies’ proprietary • 3 projects active drugs − Regeneron: XeriJectTM mAbs − Asahi Kasei: XeriJectTM biologic product − Islet Sciences: XeriSolTM co-formulation TPCs are self-funded and partner of a peptide & small molecule for resourced insulin-dependent diabetes • Several projects under discussion with Potential for project milestone pharma and biopharma companies payments and royalty stream Industry visibility for Xeris 26 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
Xeris value proposition summary Specialty pharmaceutical enterprise with two unique and broadly applicable formulation technologies Strong patent protection through 2036 Leadership position in ‘ready-to-use’ glucagon for multiple hypoglycemia indications Several near-term catalysts including 2019 revenue potential from Glucagon Rescue Pen for severe hypoglycemia Pipeline of innovative and valuable follow-on indications and product candidates Strong cash position and experienced leadership team 27 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved
28 Xeris Pharmaceuticals, Inc. ©2017-2018 All Rights Reserved