UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-40880 XERIS BIOPHARMA HOLDINGS, INC. (Exact name of the registrant as specified in its charter) Delaware 87-1082097 ...

Financial Data and Key Metrics Changes - Total product sales reached $79 million on a pro forma basis for Gvoke and Keveyis, representing a 56% increase over 2020 [11][35] - Gvoke prescriptions grew by 85% in Q4 2021 and 144% for the full year compared to the previous year [11][38] - The company ended 2021 with $102 million in cash and expects to finish 2022 with $90 million to $110 million [15][29] Business Line Data and Key Metrics Changes - Gvoke's retail market share is approximately 20%, with a 7% growth in prescriptions from Q3 to Q4 2021 [20][21] - Keveyis achieved pro forma product sales at the high end of the $38 million to $40 million guidance for 2021 [12][36] - Recorlev was launched shortly after receiving FDA approval, with an estimated total addressable market of approximately $2 billion in the US [25][26] Market Data and Key Metrics Changes - The glucagon market declined by 8% in Q4 2021, while Gvoke outperformed this trend [20][21] - The company is focused on expanding its presence in the UK and Europe through partnerships with Tetris Pharma and Merck [13] Company Strategy and Development Direction - The acquisition of Strongbridge Biopharma is seen as a critical step towards becoming a fully capable and profitable pharmaceutical company [10] - The company aims to achieve cash flow breakeven by the end of 2023, supported by strong product sales and a solid cash position [16][52] - The focus for 2022 includes driving the entire product portfolio and launching new products like the Gvoke Kit [29][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of Gvoke and Keveyis, with a positive outlook for Recorlev despite early patient data being limited [60][61] - The company anticipates achieving $105 million to $120 million in product sales for 2022 [55] Other Important Information - The company expects to realize $50 million in synergies from the Strongbridge acquisition by the end of 2022 [46] - A new senior secured term loan agreement was established, providing up to $150 million in capital [48][50] Q&A Session Summary Question: What is driving the $120 million net product revenue range for 2022? - Management highlighted a strong Q4 performance and positive early script data for 2022 as key drivers [61] Question: Can you discuss the payer environment for Recorlev? - Management indicated that most patients require prior authorization, but reimbursement is expected to be in line with established price levels [66][68] Question: What are the company's M&A priorities moving forward? - Management stated that while organic growth is the focus, M&A could be considered if it aligns with the company's strategy for critical mass and profitability [75] Question: How is the adoption of Gvoke expected to change post-pandemic? - Management noted that there is a growing recognition among physicians of the need for ready-to-use glucagon products, leading to increased adoption [76][77] Question: Will Recorlev patients need prior exposure to other therapies? - Management expects to attract patients from various products, not just those who have cycled through other therapies [78]

[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 ...

Strongbridge Biopharma plc (SBBP) Q1 2021 Earnings Conference Call May 12, 2021 8:30 AM ET Company Participants Lindsay Rocco - Elixir Health, Public Relations John Johnson - CEO Fredric Cohen - CMO Richard Kollender - President and CFO Scott Wilhoit - CCO Officer Conference Call Participants Roger Song - Jefferies Annabel Samimy - Stifel Jonathan Wolleben - JMP Securities Robin Garner - Craig-Hallum Operator Good morning ladies and gentlemen and welcome to the Strongbridge Biopharma Plc Corporate Update an ...

| --- | --- | |----------------------|-------| | | | | | | | 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]