[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for Xeris Biopharma Holdings, Inc [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Xeris Biopharma's unaudited condensed consolidated financial statements as of September 30, 2022, and for the three and nine months then ended [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The statements show total assets of **$303.0 million** as of September 30, 2022, with **total revenue of $77.1 million** and a **net loss of $81.7 million** for the nine months ended September 30, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $84,109 | $67,271 | | Total current assets | $148,919 | $142,596 | | Total assets | $303,017 | $304,361 | | Long-term debt, net | $138,507 | $88,067 | | Total liabilities | $247,977 | $209,130 | | Total stockholders' equity | $55,040 | $95,231 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $29,725 | $11,060 | $77,104 | $28,161 | | Loss from operations | $(18,780) | $(24,358) | $(66,770) | $(66,885) | | Net loss | $(21,831) | $(26,009) | $(81,730) | $(71,935) | | Net loss per share | $(0.16) | $(0.39) | $(0.60) | $(1.11) | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Account | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(86,772) | $(66,589) | | Net cash provided by investing activities | $25,293 | $61,362 | | Net cash provided by financing activities | $78,317 | $27,122 | | Increase in cash and cash equivalents | $16,838 | $21,894 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, the Strongbridge acquisition, revenue disaggregation, debt structure, and contingent value rights, confirming sufficient cash for the next 12 months - The company has three commercially available products: Gvoke for severe hypoglycemia, Keveyis for primary periodic paralysis, and Recorlev for Cushing's Syndrome[16](index=16&type=chunk)[18](index=18&type=chunk) - Despite an accumulated deficit of **$541.8 million**, management believes existing cash resources are sufficient to sustain operations for at least the next 12 months[16](index=16&type=chunk)[18](index=18&type=chunk) Disaggregated Revenue by Product (in thousands) | Product | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Gvoke | $13,663 | $37,595 | | Keveyis | $13,371 | $35,506 | | Recorlev | $2,520 | $3,623 | | **Total Product Revenue, net** | **$29,554** | **$76,724** | - The acquisition of Strongbridge on October 5, 2021, was accounted for as a business combination with a total consideration fair value of **$169.1 million**, adding Keveyis and Recorlev to the company's portfolio[46](index=46&type=chunk)[51](index=51&type=chunk) - As of September 30, 2022, total long-term debt was **$138.5 million**, comprising **$47.2 million** in Convertible Notes and a **$96.1 million** loan facility from Hayfin, entered into in March 2022[90](index=90&type=chunk)[98](index=98&type=chunk) - The fair value of the Contingent Value Rights (CVRs) liability from the Strongbridge acquisition increased to **$30.1 million** as of September 30, 2022, from **$22.5 million** at the end of 2021, resulting in a **$7.6 million loss** recognized during the nine-month period[116](index=116&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%20%28MD%26A%29) The MD&A provides management's perspective on financial condition, operational results, and liquidity, detailing the impact of the Strongbridge acquisition and product performance [Overview](index=30&type=section&id=Overview) This section outlines the company's biopharmaceutical business with three commercial products, its strategic pillars, development programs, and the ongoing impact of COVID-19 - The company's strategy is built on four pillars: maximizing the commercial potential of its three products, creating momentum towards profitability, leveraging its technology platforms for new candidates, and collaborating with other pharmaceutical companies[164](index=164&type=chunk)[166](index=166&type=chunk) - Active development programs include XP-8121 (Levothyroxine) in Phase 1, with several other programs unfunded and available for licensing[169](index=169&type=chunk)[174](index=174&type=chunk) - The COVID-19 pandemic has adversely impacted customer demand due to disruptions in patient access to healthcare and sales personnel access to customers, though the supply chain has remained intact[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) This section details the financial results for Q3 2022 versus Q3 2021, showing **168.8% revenue growth** to **$29.7 million** driven by Gvoke and the Strongbridge acquisition, alongside increased operating expenses Q3 2022 vs Q3 2021 Performance (in thousands) | Metric | Q3 2022 | Q3 2021 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $29,725 | $11,060 | $18,665 | 168.8% | | Cost of Goods Sold | $5,260 | $3,220 | $2,040 | 63.4% | | SG&A Expenses | $34,491 | $26,535 | $7,956 | 30.0% | | Loss from Operations | $(18,780) | $(24,358) | $5,578 | (22.9)% | | Net Loss | $(21,831) | $(26,009) | $4,178 | (16.1)% | - Gvoke net revenue increased by **23.8%** for the three months ended September 30, 2022, compared to the same period in 2021, driven by a **40.9% growth in prescriptions**, partially offset by lower net pricing[190](index=190&type=chunk) - Keveyis and Recorlev, acquired through the Strongbridge transaction, contributed net revenues of **$13.4 million** and **$2.5 million**, respectively, for the three months ended September 30, 2022[191](index=191&type=chunk) - The increase in Selling, General and Administrative (SG&A) expenses was primarily driven by higher personnel-related costs to support Keveyis and the launch of Recorlev, as well as an expansion of the endocrinology sales force[195](index=195&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) The company has historically funded operations through equity and debt, and management believes existing cash and access to an additional **$50.0 million** from its Hayfin loan are sufficient for at least the next 12 months - The company has funded operations through multiple equity offerings, convertible notes, and debt facilities, including a **$100.0 million** term loan from Hayfin in March 2022 with access to an additional **$50.0 million**[198](index=198&type=chunk)[200](index=200&type=chunk) - Management believes existing cash and access to the remaining **$50.0 million** from the Hayfin loan are sufficient to sustain operations and capital expenditure requirements for at least the next 12 months[201](index=201&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(86,772) | $(66,589) | | Net cash provided by investing activities | $25,293 | $61,362 | | Net cash provided by financing activities | $78,317 | $27,122 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, primarily interest rate risk from its cash, investments, and floating-rate debt, while foreign exchange risk is considered immaterial - The company is exposed to interest rate risk on its cash equivalents, investments, and its floating-rate Hayfin Loan Agreement, while Convertible Notes have a fixed rate[210](index=210&type=chunk)[211](index=211&type=chunk) - Foreign exchange risk is considered immaterial, with only minor liabilities denominated in Australian Dollars as of September 30, 2022[212](index=212&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal control over financial reporting identified - Management concluded that disclosure controls and procedures were effective as of September 30, 2022[213](index=213&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[214](index=214&type=chunk) [Part II. Other Information](index=40&type=section&id=Part%20II.%20Other%20Information) This section covers legal proceedings, risk factors, unregistered sales of equity securities, defaults, mine safety, and exhibits [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it is not currently subject to any material legal proceedings, acknowledging potential claims in the ordinary course of business - The company is not currently subject to any material legal proceedings[215](index=215&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of the numerous risks and uncertainties associated with the company's business, including financial, operational, regulatory, and competitive challenges [Risks Related to the Impact of the COVID-19 Pandemic](index=41&type=section&id=Risks%20Related%20to%20the%20Impact%20of%20the%20COVID-19%20Pandemic) The COVID-19 pandemic poses ongoing risks, including potential disruptions to sales, marketing, and supply chains, and could delay regulatory reviews, with the ultimate impact remaining uncertain - The COVID-19 pandemic continues to pose risks, potentially disrupting sales, marketing, and supply chains, and could delay regulatory reviews[218](index=218&type=chunk)[219](index=219&type=chunk)[220](index=220&type=chunk) [Risks Related to our Financial Position and Need for Financing](index=42&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Financing) The company has a limited operating history with significant losses and an accumulated deficit of **$541.8 million**, requiring potential additional capital that could be dilutive or unavailable, and faces default risks on its substantial debt - The company has a limited operating history and an accumulated deficit of **$541.8 million** as of September 30, 2022, with an expectation of continued losses in the near term[222](index=222&type=chunk)[223](index=223&type=chunk) - Additional capital may be required to sustain the business, which could lead to stockholder dilution or may not be available on favorable terms[229](index=229&type=chunk) - The company has significant debt, including **$47.2 million** in Convertible Notes and **$100.0 million** outstanding under the Hayfin Loan Agreement, and failure to make payments could lead to default and acceleration of debt[232](index=232&type=chunk)[235](index=235&type=chunk) [Risks Related to the Commercialization and Marketing of our Products and Product Candidates](index=45&type=section&id=Risks%20Related%20to%20the%20Commercialization%20and%20Marketing%20of%20our%20Products%20and%20Product%20Candidates) The company's success depends entirely on the commercial success of its products, which face risks related to market acceptance, reliance on single-source third-party suppliers, and reimbursement challenges - The business depends entirely on the commercial success of Gvoke, Keveyis, and Recorlev, which face risks related to market acceptance by physicians, patients, and payors[239](index=239&type=chunk)[240](index=240&type=chunk) - The company relies on third-party suppliers, including single-source suppliers like Bachem, Pyramid, SHL Pharma, and Taro, which could harm its ability to commercialize its products if supply is disrupted[248](index=248&type=chunk) - Reimbursement decisions by third-party payors and pricing pressures from healthcare cost-containment efforts could adversely affect pricing and market acceptance of the company's products[256](index=256&type=chunk) [Risks Related to the Product Development and Regulatory Approval of Our Product Candidates](index=50&type=section&id=Risks%20Related%20to%20the%20Product%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) Product candidates face clinical failure risks, and obtaining regulatory approval is lengthy and uncertain, with potential delays or market withdrawal due to undesirable side effects or loss of orphan drug benefits - Clinical failure can occur at any stage, and positive results from early trials do not guarantee success in later-stage trials[273](index=273&type=chunk) - The company's products may have undesirable side effects that could delay or prevent marketing approval, or if approved, lead to restrictive labeling or market withdrawal[279](index=279&type=chunk) - The company has received orphan drug designation for several products/candidates but may not be able to maintain the benefits, including market exclusivity, which expired for Keveyis on August 7, 2022[283](index=283&type=chunk) [Risks Related to our Industry and Ongoing Legal and Regulatory Requirements](index=58&type=section&id=Risks%20Related%20to%20our%20Industry%20and%20Ongoing%20Legal%20and%20Regulatory%20Requirements) The company is subject to extensive regulatory requirements and strict anti-kickback and fraud laws, facing intense competition from major pharmaceutical companies and potential generic competition - Approved products are subject to ongoing regulatory requirements for manufacturing, labeling, and marketing, and failure to comply could lead to loss of approval[299](index=299&type=chunk) - The company faces intense competition from established players like Eli Lilly, Novo Nordisk, and Corcept Therapeutics, who have greater resources[314](index=314&type=chunk)[315](index=315&type=chunk)[317](index=317&type=chunk) - Generic competition is a risk; for example, Amphastar's generic glucagon kit was approved, and Keveyis's orphan drug exclusivity has expired[318](index=318&type=chunk) [Risks Related to Our Intellectual Property](index=63&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on maintaining patent and trade secret protection, but the patent landscape is uncertain, and it faces risks of challenges, invalidation, circumvention, and costly infringement lawsuits - Success depends on the ability to obtain and maintain patent protection, but the patent process is uncertain and may not provide a meaningful competitive advantage[320](index=320&type=chunk)[321](index=321&type=chunk) - The company could become subject to costly patent litigation from third parties claiming infringement, which could prevent the marketing of its products[343](index=343&type=chunk) - Using the 505(b)(2) regulatory pathway subjects the company to the risk of patent infringement lawsuits, which can trigger an automatic 30-month stay on FDA approval[352](index=352&type=chunk) [Risks Related to Employee Matters, Managing Growth and Ongoing Operations](index=70&type=section&id=Risks%20Related%20to%20Employee%20Matters%2C%20Managing%20Growth%20and%20Ongoing%20Operations) The business could be harmed by disruptions at regulatory agencies, loss of key management, inability to attract and retain qualified employees, and stock price volatility, while incurring significant public company costs - Disruptions at the FDA and other government agencies due to funding shortages or health concerns could hinder the review and approval of new products[366](index=366&type=chunk) - The business is dependent on key members of senior management, and the loss of their services could disrupt operations[369](index=369&type=chunk) - The company's stock price has been and will likely continue to be volatile, influenced by commercial performance, regulatory actions, and market conditions[373](index=373&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no recent sales of unregistered securities and states that the use of proceeds from its initial public offering is not applicable for this reporting period - There were no unregistered sales of equity securities in the period[418](index=418&type=chunk) [Item 3. Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - Not applicable[422](index=422&type=chunk) [Item 4. Mine Safety Disclosures](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not applicable[423](index=423&type=chunk) [Item 5. Other Information](index=75&type=section&id=Item%205.%20Other%20Information) The company reports that there is no other information to disclose for this item - None[424](index=424&type=chunk) [Item 6. Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section refers to the Index to Exhibits, which lists the documents filed as part of the Quarterly Report on Form 10-Q - Refers to the Index to Exhibits for a list of filed documents[425](index=425&type=chunk)

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q3 2022 Earnings Conference Call November 9, 2022 8:30 AM ET Company Participants Allison Wey - Senior Vice President, Investor Relations and Corporate Communications Paul Edick - Chairman and CEO Steve Pieper - Chief Financial Officer Conference Call Participants Glen Santangelo - Jefferies David Amsellem - Piper Sandler Oren Livnat - H.C. Wainwright Roanna Ruiz - SVB Securities Operator Good evening or good afternoon. And welcome to the Xeris Biopharma Third Qu ...

[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) This section presents the company's unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and internal controls [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2022, show a significant increase in total revenue driven by the acquisition of Strongbridge and growth in Gvoke sales. However, the company continues to report a net loss, with an accumulated deficit of **$520.0 million**. The balance sheet reflects increased assets and liabilities, primarily due to the acquisition and new debt financing. Cash flows from operations remain negative, while financing activities provided a significant cash inflow from new debt and equity offerings Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $95,340 | $67,271 | | Total current assets | $161,206 | $142,596 | | Intangible assets, net | $126,029 | $131,450 | | Total assets | $318,616 | $304,361 | | **Liabilities & Equity** | | | | Total current liabilities | $64,545 | $79,040 | | Long-term debt, net | $138,068 | $88,067 | | Total liabilities | $244,673 | $209,130 | | Total stockholders' equity | $73,943 | $95,231 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $25,306 | $8,906 | $47,379 | $17,101 | | Loss from operations | $(18,916) | $(25,787) | $(47,990) | $(42,527) | | Net loss | $(26,185) | $(27,515) | $(59,899) | $(45,926) | | Net loss per share | $(0.19) | $(0.41) | $(0.44) | $(0.72) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(69,018) | $(43,978) | | Net cash provided by investing activities | $18,584 | $42,857 | | Net cash provided by financing activities | $78,504 | $27,121 | | **Increase in cash and cash equivalents** | **$28,069** | **$26,001** | - The company has an accumulated deficit of **$520.0 million** as of June 30, 2022, and expects to continue incurring net losses for at least the next 12 months. However, management believes existing cash and access to an additional **$50.0 million** from a credit agreement are **sufficient to sustain operations** for at least the next 12 months[21](index=21&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes on disaggregated revenue, the Strongbridge acquisition, new debt financing, and the revaluation of Contingent Value Rights Disaggregated Revenue by Product (in thousands) | Product | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Gvoke | $11,479 | $23,932 | | Keveyis | $12,812 | $22,136 | | Recorlev | $969 | $1,102 | | **Total Product Revenue, net** | **$25,260** | **$47,170** | - The acquisition of **Strongbridge** on October 5, 2021, was accounted for as a business combination, with total consideration valued at **$169.1 million**. This added **Keveyis** and **Recorlev** to the company's portfolio[47](index=47&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) - In March 2022, the company entered into a new Credit Agreement with **Hayfin Services LLP** for an initial loan of **$100.0 million**, with access to an additional **$50.0 million**. Proceeds were used to repay a previous **$43.5 million** loan and for general corporate purposes[92](index=92&type=chunk) - **Contingent Value Rights (CVRs)** issued in the **Strongbridge** acquisition are revalued each period. The fair value of the **CVR** liability increased from **$22.5 million** at year-end 2021 to **$30.2 million** at June 30, 2022, resulting in a **$7.7 million loss** recognized in the period[116](index=116&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 184% year-over-year revenue growth for Q2 2022 to the inclusion of **Keveyis** and **Recorlev** sales following the **Strongbridge** acquisition, alongside a **29.9%** increase in **Gvoke** net revenue. Operating expenses rose due to the expanded commercial infrastructure for the three products. The company secured **$100 million** in new debt financing in March 2022 and believes its current capital is **sufficient to fund operations and capital expenditures** for at least the next 12 months, despite continuing net losses - The company's core strategy focuses on four pillars: - Maximizing the commercial potential of its three products: **Gvoke**, **Keveyis**, and **Recorlev** - Achieving profitability through commercial execution - Leveraging its technology platforms (**XeriSol** and **XeriJect**) to develop new product candidates - Collaborating with other pharmaceutical companies to apply its technology platforms[163](index=163&type=chunk)[165](index=165&type=chunk) Results of Operations Comparison (in thousands) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Total revenue | $25,306 | $8,906 | 184.1% | | Cost of goods sold | $4,810 | $3,383 | 42.2% | | R&D Expenses | $3,718 | $5,383 | (30.9)% | | SG&A Expenses | $32,984 | $25,927 | 27.2% | | Net loss | $(26,185) | $(27,515) | (4.8)% | - **Gvoke** net revenue grew **29.9%** for the three months and **41.7%** for the six months ended June 30, 2022, compared to the same periods in 2021, driven by prescription growth of **60.4%** and **72.6%** respectively, though partially offset by lower net pricing[187](index=187&type=chunk) - The company believes its cash, cash equivalents, investments, expected product revenue, and access to an additional **$50.0 million** from the **Hayfin Loan Agreement** are **sufficient to fund operations and capital expenditures** for at least the next 12 months[173](index=173&type=chunk)[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is primarily exposed to market risks from interest rate fluctuations on its cash, investments, and variable-rate debt. Foreign currency exchange risk is considered immaterial as of the reporting date - The company's primary market risk is **interest rate risk**, affecting interest income on cash and investments and interest expense on its **SOFR-indexed long-term debt** under the **Hayfin Loan Agreement**[208](index=208&type=chunk)[209](index=209&type=chunk) - Foreign exchange risk is currently **minimal**, with only immaterial liabilities denominated in **Australian Dollars** as of June 30, 2022[210](index=210&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's **disclosure controls and procedures** and concluded they were **effective** as of June 30, 2022. No material changes to **internal control over financial reporting** were identified during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's **disclosure controls and procedures** were **effective** as of the end of the period covered by this report[211](index=211&type=chunk) - There were **no changes** in the company's **internal control over financial reporting** during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[212](index=212&type=chunk) [Part II. Other Information](index=41&type=section&id=Part%20II.%20Other%20Information) This section covers legal proceedings, significant risk factors, unregistered equity sales, other disclosures, and a list of filed exhibits [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is **not a party** to any **material legal proceedings**. It may become involved in various legal actions in the ordinary course of business, but none are expected to have a **material adverse effect** - As of the report date, the company is **not a party** to any **legal proceedings** that are expected to have a **material adverse effect** on its business[213](index=213&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous significant risks that could materially affect its business. Key risks include the ongoing impact of the **COVID-19 pandemic**, a **limited operating history** with **significant losses**, dependence on the commercial success of its three products, reliance on **third-party** suppliers, potential for clinical trial failures, competition, and the ability to protect its intellectual property - The business may be adversely affected by the ongoing **COVID-19 pandemic**, which could disrupt supply chains, impact customer demand, and delay regulatory reviews[215](index=215&type=chunk)[216](index=216&type=chunk) - The company has a **limited operating history**, has incurred **significant losses** since inception (accumulated deficit of **$520.0 million** as of June 30, 2022), and may not achieve or sustain profitability[219](index=219&type=chunk)[220](index=220&type=chunk) - The business depends entirely on the commercial success of its products **Gvoke**, **Keveyis**, and **Recorlev**, and its product candidates, which may not be accepted in the marketplace[237](index=237&type=chunk) - The company relies on **third-party**, and in some cases **single-source**, suppliers for manufacturing its products, which could harm its ability to commercialize them if these suppliers fail to perform[246](index=246&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=79&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 - There were **no unregistered sales of equity securities** in the reported quarter[414](index=414&type=chunk) [Other Information](index=79&type=section&id=Item%205.%20Other%20Information) There is **no information** to be reported under this item for the quarter - The company reported **no information** for this item[419](index=419&type=chunk) [Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including amendments to agreements and officer **certifications** - Exhibits filed with the report include an amendment to the **API Supply Agreement** with **Bachem Americas, Inc.**, and **certifications** from the Principal Executive Officer and Principal Financial Officer[423](index=423&type=chunk)

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q2 2022 Earnings Conference Call August 10, 2022 8:30 AM ET Company Participants Allison Wey - Senior Vice President of Investor Relations and Corporate Communications Paul Edick - Chairman and Chief Executive Officer Steve Pieper - Chief Financial Officer Conference Call Participants Roanna Ruiz - SVB Securities Oren Livnat - H.C. Wainwright David Amsellem - Piper Sandler Operator Hello, and welcome to today’s Xeris Biopharma’s Second Quarter 2022 Financial Resu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 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) (State or other ...

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q1 2022 Earnings Conference Call May 11, 2022 8:30 AM ET Company Participants Allison Wey - SVP, IR & Corporate Communications Paul Edick - Chairman & CEO Steve Pieper - CFO Conference Call Participants David Amsellem - Piper Sandler Roanna Ruiz - SVB Securities Vamil Divan - Mizuho Securities Robin Garner - Craig-Hallum Oren Livnat - H.C. Wainwright Operator Hello, and welcome to today’s Xeris Biopharma’s First Quarter 2022 Financial Results Conference Call and ...

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 ...