[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended September 30, 2021, reflect increased net sales driven by Gvoke, a widening net loss, and a balance sheet showing decreased cash and investments, increased liabilities, and a stockholders' deficit, with the Strongbridge acquisition details provided in notes as a subsequent event [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of **September 30, 2021**, total assets decreased to **$131.3 million** from **$159.2 million**, while total liabilities increased to **$133.7 million** from **$125.4 million**, resulting in a stockholders' deficit of **$2.5 million** compared to a **$33.8 million** positive equity at year-end 2020 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 (unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,492 | $37,598 | | Short-term investments | $33,491 | $96,190 | | Total current assets | $124,367 | $152,212 | | **Total assets** | **$131,260** | **$159,151** | | **Liabilities & Equity** | | | | Total current liabilities | $37,285 | $28,207 | | Long-term debt, net | $87,713 | $87,021 | | **Total liabilities** | **$133,721** | **$125,390** | | **Total stockholders' (deficit) equity** | **($2,461)** | **$33,761** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and nine months ended **September 30, 2021**, net sales significantly grew due to Gvoke, but increased operating expenses, especially in SG&A, led to a higher net loss for both periods, though net loss per share improved from **($1.78)** to **($1.11)** for the nine-month period Financial Performance Summary (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | YTD 2021 | YTD 2020 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $11,035 | $9,404 | $27,921 | $13,066 | | Gross profit | $7,840 | $6,616 | $19,732 | $7,342 | | Research and development | $5,663 | $3,876 | $15,078 | $15,811 | | Selling, general and administrative | $26,535 | $16,484 | $71,539 | $55,734 | | Loss from operations | ($24,358) | ($13,744) | ($66,885) | ($64,203) | | **Net loss** | **($26,009)** | **($16,000)** | **($71,935)** | **($69,283)** | | Net loss per common share | ($0.39) | ($0.35) | ($1.11) | ($1.78) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended **September 30, 2021**, net cash used in operating activities was **$66.6 million**, offset by **$61.4 million** from investing activities and **$27.1 million** from financing, resulting in a net increase in cash and cash equivalents of **$21.9 million** Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($66,589) | ($69,689) | | Net cash provided by (used in) investing activities | $61,362 | ($34,654) | | Net cash provided by financing activities | $27,122 | $122,738 | | **Increase in cash and cash equivalents** | **$21,894** | **$18,367** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, the significant post-quarter-end acquisition of **Strongbridge** for **$169.1 million** adding **Keveyis** and **Recorlev**, accounting policies, and debt structure including **$47.2 million** in convertible notes and a **$43.5 million** senior secured loan, alongside a **$26.9 million** equity offering in **March 2021** - On **October 5, 2021**, after the reporting period, the company completed its acquisition of **Strongbridge Biopharma**. The transaction is not reflected in the Q3 2021 balance sheet or income statement[20](index=20&type=chunk)[43](index=43&type=chunk) Preliminary Acquisition Consideration for Strongbridge (in thousands) | Component | Fair Value | | :--- | :--- | | Xeris Biopharma Holdings, Inc. common shares | $137,655 | | Unexercised Strongbridge options assumed | $6,404 | | Strongbridge warrants | $2,467 | | Contingent consideration (CVRs) | $22,531 | | **Total consideration** | **$169,057** | - The acquisition adds **Keveyis®** (approved for primary periodic paralysis) and **Recorlev®** (a clinical-stage candidate for Cushing's syndrome with a PDUFA date of **January 1, 2022**) to the company's portfolio[27](index=27&type=chunk) Unaudited Pro Forma Operating Results (in thousands) | Metric | Q3 2021 | YTD 2021 | | :--- | :--- | :--- | | Revenue | $22,556 | $58,081 | | Net loss attributable to Xeris | ($23,965) | ($82,183) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management highlights the **Strongbridge** acquisition as a strategic expansion into rare diseases, focusing on commercializing **Gvoke** and **Keveyis** and preparing for **Recorlev's** launch, with **Gvoke** net sales increasing to **$27.9 million** for the first nine months of **2021** from **$13.1 million**, despite higher SG&A expenses and **$6.2 million** in acquisition costs, while maintaining sufficient cash for the next **12 months** - The company's key priority is the commercialization of **Gvoke** and **Keveyis**, and the pre-commercialization preparations for the anticipated launch of **Recorlev** in **Q1 2022**, subject to FDA approval[152](index=152&type=chunk) Gvoke Net Sales (in millions) | Period | 2021 | 2020 | | :--- | :--- | :--- | | Three Months Ended Sep 30 | $11.0 | $9.4 | | Nine Months Ended Sep 30 | $27.9 | $13.1 | - The increase in SG&A expenses for the nine months ended **Sep 30, 2021** was primarily driven by a **$10.3 million increase** in personnel costs from sales force expansion and **$6.2 million** in transaction-related expenses for the **Strongbridge acquisition**[60](index=60&type=chunk)[182](index=182&type=chunk) - The company believes its cash resources as of **September 30, 2021**, are sufficient to sustain operations and capital expenditure requirements for at least the **next 12 months**[28](index=28&type=chunk)[186](index=186&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces market risks from interest rate fluctuations affecting income and floating-rate debt expenses, while foreign currency risk is currently considered immaterial - A hypothetical **one-percentage point change** in interest rates would impact annual interest income by approximately **$0.9 million**[197](index=197&type=chunk) - The company's long-term debt under the Amended Loan Agreement has a floating interest rate based on LIBOR, but a **1% increase** would have no impact as the current rate is below the **2.43% floor**. The Convertible Notes have a fixed **5.0% interest rate**[198](index=198&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of **September 30, 2021**, with no material changes in internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were **effective as of September 30, 2021**[200](index=200&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[201](index=201&type=chunk) [Part II. Other Information](index=39&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings, and no ordinary course legal actions are expected to have a material adverse effect - As of the report date, the company is not a party to any claim or litigation that is reasonably expected to have a **material adverse effect** on the business[203](index=203&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company outlines numerous risks, emphasizing the integration of the **Strongbridge** acquisition, the ongoing impact of the **COVID-19 pandemic**, and its financial position, including potential failure to realize merger benefits, continued operating losses, reliance on **Gvoke** and **Keveyis**, manufacturing dependence, reimbursement challenges, and risks in clinical development, regulatory approval for **Recorlev**, intellectual property, and competition - A primary risk is the failure to successfully integrate the businesses of **Xeris Pharma** and **Strongbridge**, which could prevent the realization of anticipated cost savings and operational synergies[205](index=205&type=chunk) - The **COVID-19 pandemic** continues to pose a risk by potentially disrupting patient access to healthcare, sales and marketing efforts, and the operations of third-party suppliers and manufacturers[211](index=211&type=chunk)[213](index=213&type=chunk) - The company has a history of significant losses (**$409.3 million accumulated deficit** as of **Sep 30, 2021**) and expects to incur further losses as it commercializes its products and develops its pipeline[216](index=216&type=chunk)[217](index=217&type=chunk) - The business is highly dependent on the success of its commercial products **Gvoke** and **Keveyis**, and its late-stage candidate **Recorlev**. Market acceptance, physician adoption, and third-party payor reimbursement are critical[231](index=231&type=chunk)[233](index=233&type=chunk)[235](index=235&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period, and the use of IPO proceeds is not applicable for this reporting period - There were **no unregistered sales** of equity securities in the period[458](index=458&type=chunk) [Defaults Upon Senior Securities](index=90&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable, as the company reported no defaults upon senior securities - Not applicable[460](index=460&type=chunk) [Mine Safety Disclosures](index=90&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable, as the company has no mine safety disclosures - Not applicable[461](index=461&type=chunk) [Other Information](index=90&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[462](index=462&type=chunk) [Exhibits](index=90&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including officer certifications and XBRL data files [Signatures](index=92&type=section&id=Signatures) The report is duly signed by the company's Chief Executive Officer and Chief Financial Officer on November 10, 2021

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q3 2021 Earnings Conference Call November 10, 2021 8:30 AM ET Company Participants Allison Wey - Senior Vice President, Investor Relations and Corporate Communications Paul Edick - Chairman and Chief Executive Officer Steve Pieper - Chief Financial Officer Conference Call Participants David Amsellem - Piper Sandler Oren Livnat - H.C. Wainwright David Steinberg - Jefferies Alexandre Bouilloux - Mizuho Securities Kelley Prince - Close Concerns Operator Welcome to ...

| --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | | | | | Forward-looking statements 2 This document contains forward‐looking statements relating to the Company's strategy, objectives, business development plans, financial position, clinical development, regulatory plans and revenue guidance. All statements other than statements of historical facts included in this document, including, without limitation, statements regarding the Company's future financial position, strategy, anticipated ...

Financial Data and Key Metrics Changes - Net revenue from KEVEYIS increased by $1.7 million or 25% to $8.4 million compared to $6.7 million for the same period in 2020 [19][22] - Gross margins improved to 95% from 85% in the same period last year [22] - Basic net loss attributable to ordinary shareholders decreased to $11.8 million or $0.18 per share from $12.7 million or $0.23 per share in the same period in 2020 [24][25] - Non-GAAP basic net loss attributable to ordinary shareholders was $7.2 million or $0.11 per share compared to $10.3 million or $0.19 per share for the same period in 2020 [25] Business Line Data and Key Metrics Changes - KEVEYIS achieved strong sales results with a 25% quarter-over-quarter revenue growth, marking the highest month of revenue ever in April since its launch in 2017 [10][19] - The company remains on track to achieve full-year KEVEYIS revenue guidance of $34 million to $36 million [10][67] Market Data and Key Metrics Changes - The company is awaiting the Day 74 Letter from the FDA regarding the NDA submission for RECORLEV, which is expected to confirm filing acceptance and provide a target action date [15][37] - Market research indicates significant unmet needs in the treatment of endogenous Cushing's syndrome, particularly among women [6][32] Company Strategy and Development Direction - The company is focused on driving continued revenue growth for KEVEYIS while preparing for the launch of RECORLEV upon FDA approval [12][21] - Strongbridge aims to optimize the value of RECORLEV and strengthen its leadership position in rare endocrine diseases [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for RECORLEV to address unmet needs in the Cushing's syndrome market, with a focus on patients not well controlled by current therapies [32][49] - The company anticipates a cash runway extending into and potentially beyond the first quarter of 2023, providing flexibility for future capital access [26] Other Important Information - Strongbridge was recognized as a 2021 Great Place to Work certified company, highlighting its positive workplace culture [13] - The company is actively pursuing intellectual property developments related to both KEVEYIS and RECORLEV [11][68] Q&A Session Summary Question: What are the key drivers for the improved discontinuation rate for KEVEYIS? - Management highlighted the importance of setting expectations with physicians and patients early in the treatment cycle and improving engagement through consistent communication [30] Question: What is the expected pent-up demand for RECORLEV upon launch? - Management noted significant unmet needs, with up to 40% of patients not well controlled, indicating potential demand for RECORLEV [32] Question: What feedback has been received regarding RECORLEV data? - Physicians have expressed that RECORLEV's titration scheme and efficacy are competitive, with potential advantages for women experiencing androgenic side effects [45][46] Question: How does being an Irish company impact tax strategies? - Management indicated potential tax advantages due to expected increases in corporate tax rates in the U.S. compared to anticipated rates for an Irish company [38] Question: Are there updates on KEVEYIS IP? - The company continues to prosecute its IP and expects to provide further updates in the second half of the year [68]

| --- | --- | |----------------------|-------| | | | | | | | Unlocking the | | | potential of today's | | | | | | medicines for | | | profound impact | | March 2021 Xeris Pharmaceuticals, Inc. ©2017-2020 All Rights Reserved Forward-looking Statements 2 This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the rate and degree of market acceptance and clinical utility of Gvoke®, the market and the the ...

Financial Data and Key Metrics Changes - For the full year 2020, net revenues from sales of KEVEYIS increased by $9 million or 41.5% from $21.7 million in 2019 to $30.7 million in 2020 [21] - Gross margins improved to 93% for 2020 compared to 82% in 2019 [21] - Selling, general and administrative expenses decreased to $40.9 million in 2020 from $49.1 million in 2019 [22] - Research and development expenses decreased to $25.8 million in 2020 from $30.9 million in 2019 [23] - The company ended 2020 with approximately $87.5 million in cash, expecting to have more than one year's worth of cash at the time of potential RECORLEV FDA approval [25][26] Business Line Data and Key Metrics Changes - KEVEYIS revenues for Q4 2020 were $8.2 million, exceeding the projected guidance range of $28 million to $29 million for the full year [14] - The company is actively preparing for the launch of RECORLEV, having submitted its New Drug Application to the FDA [9][12] Market Data and Key Metrics Changes - The company is focused on the Cushing's syndrome market, which has an estimated 8,000 patients in the US who are treated with prescription therapy [10] - The competitive landscape includes ISTURISA, which has been benchmarked against RECORLEV [32] Company Strategy and Development Direction - The company aims to leverage its rare disease commercialization expertise to bring RECORLEV to market [13] - There is a focus on maintaining and growing the active patient base for KEVEYIS while preparing for RECORLEV's launch [15][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of KEVEYIS despite the challenges posed by the COVID-19 pandemic [8] - The company anticipates that increased vaccination rates will improve patient access to healthcare providers, potentially leading to more diagnoses and treatments [16][82] - Management remains optimistic about the potential approval of RECORLEV and its market positioning [12][74] Other Important Information - The interim safety and efficacy results from the Phase 3 LOGICS study will be presented at the Endocrine Society's ENDO 2021 Annual Meeting [12] - The company is actively working on its go-to-market strategy for RECORLEV, including market access activities and healthcare provider research [18][19] Q&A Session Summary Question: What are the expectations for the Cushing's syndrome landscape and how does RECORLEV compare to ISTURISA? - Management believes RECORLEV has a competitive profile and sees opportunities in the underserved female population [33][34] Question: Can you provide updates on KEVEYIS performance during the pandemic? - Management attributes KEVEYIS's strong performance to proactive engagement with healthcare providers and patients [52][53] Question: What are the plans for Veldoreotide? - Management is still evaluating options for Veldoreotide and will provide updates in the future [41][42] Question: What can be expected from the ENDO presentation? - The presentation will provide detailed efficacy and safety analyses from the LOGICS study [50] Question: How many patients are currently being treated with KEVEYIS? - Management has not disclosed the exact number of patients but estimates there are 4,000 to 5,000 diagnosed PPP patients in the market [94][95] Question: What additional launch preparedness activities are needed for RECORLEV? - Key activities include market access, advocacy, and optimizing sales force structure [96][100]

| --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | | | | | Forward-looking statements 2 This document contains forward‐looking statements relating to the Company's strategy, objectives, business development plans, financial position, clinical development, regulatory plans and revenue guidance. All statements other than statements of historical facts included in this document, including, without limitation, statements regarding the Company's future financial position, strategy, anticipated ...

Recorlev (levoketoconazole) for Cushing's Syndrome - NDA submission for Recorlev is anticipated in Q1 2021[6], with a potential U S launch in Q1 2022 if approved[71] - Recorlev's addressable market for Cushing's syndrome is estimated to exceed $2 billion annually[6] - Phase 3 SONICS study showed 30% of patients achieved mUFC normalization without a dose increase[34] - Phase 3 LOGICS study demonstrated 54 5% more patients lost response on placebo than on levoketoconazole (p-value: 0 0002)[56] - U S market assessment indicates Recorlev could achieve peak sales potential of $250 million to $350 million annually[74] Keveyis (dichlorphenamide) for Primary Periodic Paralysis - Keveyis generated an expected revenue of $28 million to $29 million in 2020[6] - The total addressable market for Keveyis is more than $500 million annually[6] - Strongbridge believes Keveyis has the potential to exceed peak sales of $50 million annually[126] Financial Position - Strongbridge projects it can fund operations into and potentially beyond Q1 2023, with approximately $82 million in cash as of September 30, 2020[131, 132]

Strongbridge Biopharma plc (SBBP) Q3 2020 Earnings Conference Call October 29, 2020 4:30 PM ET Company Participants Lindsay Rocco - Elixir Health, Public Relations John Johnson - CEO Fred Cohen - Chief Medical Officer Rob Lutz - CFO Scott Wilhoit - Chief Commercial Officer Rich Kollender - COO Conference Call Participants Annabel Samimy - Stifel Chris Howerton - Jefferies Justin Kim - Oppenheimer Jonathan Wolleben - JMP Securities Operator Good afternoon, ladies and gentlemen and welcome to Strongbridge Bio ...

Strongbridge Biopharma plc (SBBP) Q2 2020 Earnings Conference Call August 4, 2020 8:30 AM ET Â Company Participants Lindsay Rocco - Elixir Health, Public Relations John Johnson - Chief Executive Officer Fred Cohen - Chief Medical Officer Rob Lutz - Chief Financial Officer Scott Wilhoit - Chief Commercial Officer Rich Kollender - Chief Operating Officer Conference Call Participants Chris Howerton - Jefferies Hartaj Singh - Oppenheimer and Company Avatar Jones - Stifel Jonathan Wolleben - JMP Securities Opera ...