Xeris Biopharma Holdings Inc. (NASDAQ:XERS) Q4 2023 Earnings Conference Call March 6, 2024 8:30 AM ET Company Participants Paul Edick - Chairman, Chief Executive Officer Steve Pieper - Chief Financial Officer Allison Wey - Senior Vice President, Investor Relations Conference Call Participants Oren Livnat - HC Wainwright Glen Santangelo - Jefferies Chase Knickerbocker - Craig Hallum Roanna Ruiz - Leerink Partners David Amsellem - Piper Sandler Operator Hello everyone and welcome to the Xeris fourth quarter a ...

Table of Contents 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 September 30, 2023 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 ch ...

Financial Data and Key Metrics - Total net revenue for Q3 2023 was $48 million, a 63% increase compared to Q3 2022 and a 27% increase from Q2 2023 [5] - Full-year 2023 revenue guidance was tightened to $160 million to $165 million, expecting to hit the top end of the original guidance [6] - Cash position at the end of Q3 2023 was approximately $66 million, with expectations to achieve cash flow breakeven in Q4 2023 [21][35] Business Line Performance - Gvoke generated $17.7 million in net revenue in Q3 2023, a 30% increase compared to Q3 2022, with total prescriptions growing 52% year-over-year [7][24] - Recorlev generated $8.1 million in net revenue in Q3 2023, a 221% increase compared to Q3 2022 and a 13% increase from Q2 2023 [11][26] - Keveyis generated $15.9 million in net revenue in Q3 2023, a 19% increase compared to Q3 2022 and a 13% increase from Q2 2023 [13][27] Market Performance - Gvoke's market share in the retail glucagon market grew to approximately 33% for new prescriptions and 31% for total prescriptions by the end of October 2023 [8] - The glucagon prescription market grew 16% in Q3 2023, with Gvoke's total prescriptions growing 14% in the same period [25] - Recorlev's patient demand grew 12% over Q2 2023, with strong referrals indicating future growth potential [11][26] Strategic Direction and Industry Competition - The company is focused on building a patient-centric, self-sustaining biopharma enterprise, with strong execution across its three business pillars: commercial products, new product development, and technology partnerships [5][6] - Gvoke continues to outpace competitors in the glucagon market, with the company investing in sales team expansion to maintain momentum [8][9] - Recorlev is gaining traction as a first-line treatment for Cushing's syndrome, with healthcare professionals valuing its multipronged approach to cortisol suppression [12] Management Commentary on Operating Environment and Future Outlook - Management expects total net revenue to grow from 2023 levels in 2024, with operating expenses remaining flat and continued reduction in cash burn [19][38] - The company is optimistic about the large market opportunity for Gvoke, with less than 10% of at-risk patients currently having a ready-to-use glucagon product [9][10] - The XeriJect technology platform is seen as a key differentiator, with successful formulation of TEPEZZA and ongoing collaborations with Amgen and Regeneron [15][17] Other Important Information - The company successfully formulated the ultra-concentrated subcutaneous version of XeriJect TEPEZZA, triggering a $6 million success payment from Amgen [15][23] - The Phase 2 study for XeriSol levothyroxine is over 80% enrolled, with data expected mid-2024 to inform the Phase 3 program [14] - The company exchanged approximately two-thirds of its 2025 convertible senior notes for 2028 notes, reducing near-term debt obligations [22] Q&A Session Summary Questions on Recorlev - Management discussed Recorlev's patient footprint and competitive landscape, noting strong referral growth and low discontinuation rates [40][44][46] - The company views Corcept's relacorilant as a potential competitor but believes Recorlev's superior product performance will maintain its market position [42] Questions on Gvoke - Management highlighted Gvoke's strong growth in the glucagon market, with a 50% increase in prescriptions year-to-date [59] - The company sees Amphastar's Baqsimi as a positive addition to the market, helping to increase awareness and adoption of ready-to-use glucagon products [41] Questions on Financials and Strategy - The company is committed to achieving cash flow breakeven in Q4 2023 and does not anticipate shareholder dilution [50] - Operating expenses are growing at a slower rate than revenue, with SG&A expenses expected to decrease further in Q4 2023 [52][54] - Management is focused on maintaining a self-sustaining business model and investing in growth opportunities rather than pursuing share buybacks [56] Questions on XeriJect Technology - The XeriJect platform offers competitive advantages in delivering ultra-high concentrated subcutaneous injections, with potential to move IV-administered drugs to self-administration [69] - Partnerships with Amgen and Regeneron are progressing well, but timelines for further development and commercialization depend on partner decisions [67][68] Questions on Future Plans - The company is actively evaluating potential acquisitions and pipeline additions but remains disciplined in resource allocation [65][76] - Management is committed to building a growth-oriented biopharmaceutical company and improving patient lives across its range of therapies [79]

Table of Contents 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 June 30, 2023 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 ...

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q2 2023 Results Conference Call August 8, 2023 8:30 AM ET Company Participants Allison Wey - Senior Vice President of Investor Relations Paul Edick - Chairman and Chief Executive Officer Steven Pieper - Chief Financial Officer Conference Call Participants Oren Livnat - H. C. Wainwright Glen Santangelo - Jefferies Operator Good morning all. I would like to welcome you all to Xeris Biopharma Second Quarter 2023 Financial Results Call. My name is [Prika], and I will be ...

Table of Contents 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, 2023 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 charte ...

Xeris Biopharma Holdings, Inc. (NASDAQ:XERS) Q1 2023 Earnings Conference Call May 9, 2023 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 Oren Livnat - H.C. Wainwright Glen Santangelo - Jefferies Roanna Ruiz - SVB Securities Operator Hello all and warm welcome to the Xeris Biopharma Holding First Quarter 2023 Financial Res ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the fiscal year ended December 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) 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 Delaware 87-1082097 ...

Financial Data and Key Metrics Changes - The company reported a net product revenue growth of 52% for Q4 2022 and 38% for the full year on a pro forma basis, finishing the year with $110 million in total revenue [9][34] - Cash on hand exceeded $120 million at year-end 2022, indicating strong liquidity [9] - Total net product revenue for 2022 was over $109 million, achieving the top end of guidance [34] Business Line Data and Key Metrics Changes - Gvoke achieved net revenue of $15 million in Q4 2022, a 36% increase year-over-year, with total prescriptions growing over 42% [11][12] - Keveyis generated approximately $14 million in Q4 2022, representing a 33% increase, and over $49 million for the full year, a 23% increase [17][39] - Recorlev net revenue for Q4 was $3.8 million, a 51% increase from the previous quarter, with total revenue for 2022 at $7.4 million [19][41] Market Data and Key Metrics Changes - The total glucagon market grew 6% in Q4 2022 and 9% for the full year, with Gvoke outpacing market growth [13] - Gvoke's market share of new prescriptions reached approximately 28%, with ready-to-use glucagon products representing nearly 75% of the new prescription market [14] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven in Q4 2023 without needing additional capital, positioning itself as a self-sustaining enterprise [10][52] - The focus is on advancing the levothyroxine program and developing partnerships, such as the collaboration with Horizon Therapeutics for TEPEZZA [21][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth and the potential for a pivotal year in 2023, driven by strong revenue growth and disciplined expense management [31][55] - The company anticipates total revenues between $135 million and $165 million for 2023, reflecting a growth rate of approximately 36% from 2022 [31][42] Other Important Information - The company has not yet experienced a negative impact from the first generic entry of Keveyis, although it remains a concern for the future [17][40] - The company is preparing for potential impacts from deductible resets on patient access to Recorlev, which is common in rare disease products [72] Q&A Session Summary Question: Guidance range and factors affecting it - Management acknowledged the wider guidance range due to multiple moving parts, including the early stage of Recorlev's launch and uncertainty regarding Keveyis' generic impact [56][57] Question: Current market status of Keveyis - Management confirmed that no generics are currently operational in the market, and patient support systems are in place to maintain business [59][60] Question: Titration process for Recorlev - Management indicated that titration is slower in real-world settings compared to clinical studies, with physicians managing doses carefully [64][66] Question: Contribution from other revenues - Management noted that the contribution from partnerships and collaborations is uncertain and depends on the speed of achieving target product profiles [69][70] Question: Payer coverage for Recorlev - Management reported that prior authorization hurdles exist but success rates are better than 50%, with many appeals resulting in approvals [74][76] Question: Gvoke's growth outlook - Management expects Gvoke to continue its growth trajectory, with minimal impact from generics and a rebound in market growth [80][81] Question: Competitive dynamics for Recorlev - Management believes Recorlev is performing well against competitors, with a focus on demonstrating its efficacy compared to existing treatments [82][84] Question: Timeline for levothyroxine injectable product - Management indicated that the earliest filing for the levothyroxine injectable product could be between 2026 and 2028, depending on the Phase 2 study outcomes [87]

[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)