CONCORD, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- RFK Racing and Esperion Therapeutics have announced the promotional schedule for the 2024 season, highlighted by a four-race slate, and numerous accompanying campaigns and initiatives, all driving awareness of its two brands – NEXLIZET (bempedoic acid and ezetimibe) and NEXLETOL (bempedoic acid) used for adults on a statin to reduce LDL-cholesterol. Esperion's season debut comes in the first race at Richmond this spring (March 31) on the No. 17 of Chris Buesc ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $34 million, representing a 79% increase year-over-year [61] - US net revenue was $20.3 million, a 45% increase year-over-year, driven by a 33% year-over-year increase in retail prescription equivalents [45] - Collaboration revenue, including combined royalty and partner revenue, was $13.7 million, an increase of approximately 174% year-over-year [54] - Cost of goods sold was $13.4 million, an increase of 106% year-over-year [13] - R&D expense was $14.9 million, a decrease of 49% year-over-year [13] - SG&A expense was $33.2 million, an increase of 33% year-over-year [55] - Cash equivalents and investment securities totaled $114.8 million as of September 30, 2023, down from $166.9 million on December 31, 2022 [62] Business Line Data and Key Metrics Changes - Retail prescription equivalents (RPE) grew 33% year-over-year and 8% quarter-over-quarter [11] - New-to-brand prescriptions grew 61% from March to September 2023 [46] - Weekly RPE trend remained above the 10,000 RPE mark, setting new weekly highs [53] Market Data and Key Metrics Changes - Three additional countries (Netherlands, Slovakia, and Spain) received approvals during Q3 2023 [12] - In Europe, 158,000 patients have been treated with the therapies, representing a sequential growth of 26% since May [60] Company Strategy and Development Direction - The company is focused on expanding its label to include cardiovascular risk reduction, which is seen as a significant growth catalyst [49] - A strategic collaboration with ACC and Amgen was announced to launch a cholesterol screening campaign [50] - The company anticipates a new label approval by March 31, 2024, which will significantly increase the addressable patient population [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing litigation case and the potential for a positive ruling [20] - The company is preparing for the new label and expects to see accelerated prescription growth following the approval [49] - Management highlighted the importance of payer changes to realize the full potential of the new label [73] Other Important Information - The company is managing expenses diligently while preparing for a full-scale commercial launch next year [14] - The litigation case with Daiichi is ongoing, with a trial date set for April 15, 2024 [57] Q&A Session Summary Question: What is the outlook for gross-to-net trends in Q4? - Management noted typical seasonality in Q3 and expects continued improvement in gross-to-net trends over the longer term [19] Question: When could the milestone from the litigation case hit Esperion's balance sheet? - Management indicated that the milestone would not be recognized until early 2024, and they remain confident in the timeline [66] Question: How does the company plan to attract physicians interested in the drug? - Management mentioned that the team is unable to discuss new data until the label changes, which will help in expanding the population [22] Question: What is the typical patient profile for bempedoic acid? - The typical patient is on maximally tolerated statin therapy and not at their LDL-C goal, with a strong desire for primary prevention [80] Question: What are the approval rates for the therapies? - Approval rates have reached approximately 85% in commercial and Medicare, following presentations of CVOT data [83]

• On max tolerated statin Important Safety Information | --- | --- | |-------------------------------------|----------------------| | FY 2023 R&D Guidance | $100 - 110 Million | | FY 2023 SG&A Guidance | $125 - 135 Million | | FY 2023 Op Ex Guidance1 | $225 - 245 Million | | Q3 2023 Common Shares Outstanding 2 | 112.1 Million | © 2023 Esperion. All/Rights Reserved – Do not copy or distribute. 13 © 2023 Esperion. All Rights Reserved – Do not copy or distribute. Corporate Update • Filed Rule 12(c) motion, req ...

PART I — FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed interim financial statements for Esperion Therapeutics, Inc. as of September 30, 2023, and for the three and nine-month periods then ended [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2023, total assets decreased to $221.3 million from $247.9 million, while total liabilities increased to $631.3 million from $571.7 million, widening the stockholders' deficit Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 (unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $114,833 | $124,775 | | Inventories, net | $51,435 | $35,201 | | Total current assets | $218,227 | $246,683 | | Total assets | $221,305 | $247,939 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $137,708 | $92,308 | | Convertible notes, net | $261,165 | $259,899 | | Revenue interest liability | $267,400 | $243,605 | | Total liabilities | $631,309 | $571,717 | | Total stockholders' deficit | $(410,004) | $(323,778) | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q3 2023, total revenues increased to $34.0 million, and the net loss narrowed to $41.3 million, with similar trends observed for the nine-month period Three Months Ended September 30, (in thousands, except per share data) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Product sales, net | $20,251 | $13,964 | | Collaboration revenue | $13,718 | $5,016 | | **Total Revenues** | **$33,969** | **$18,980** | | Loss from operations | $(27,533) | $(41,623) | | **Net loss** | **$(41,250)** | **$(55,117)** | | Net loss per share | $(0.37) | $(0.81) | Nine Months Ended September 30, (in thousands, except per share data) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Product sales, net | $57,575 | $40,896 | | Collaboration revenue | $26,509 | $15,761 | | **Total Revenues** | **$84,084** | **$56,657** | | Loss from operations | $(113,196) | $(136,988) | | **Net loss** | **$(152,904)** | **$(178,172)** | | Net loss per share | $(1.53) | $(2.78) | [Condensed Statements of Stockholders' Deficit](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Deficit) The stockholders' deficit increased to $410.0 million by September 30, 2023, primarily due to a net loss, partially offset by capital raised from equity issuances - The total stockholders' deficit grew to **$(410.0) million** at September 30, 2023, from **$(323.8) million** at December 31, 2022[15](index=15&type=chunk) - Key activities impacting the deficit during the first nine months of 2023 included a net loss of **$152.9 million**, stock-based compensation of **$9.0 million**, and net proceeds from stock and warrant issuances of approximately **$56.9 million**[15](index=15&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities improved, resulting in a $9.9 million net decrease in cash and cash equivalents Cash Flow Summary for Nine Months Ended Sep 30, (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(98,431) | $(132,355) | | Net cash provided by investing activities | $42,500 | $19,898 | | Net cash provided by financing activities | $45,989 | $62,964 | | **Net decrease in cash and cash equivalents** | **$(9,942)** | **$(49,493)** | | Cash, cash equivalents at end of period | $114,833 | $209,399 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail accounting policies, the successful CLEAR Outcomes trial, sNDA submissions, a dispute with DSE over a $300 million milestone, and recent equity financing - The company completed its CLEAR Outcomes trial, which met its primary endpoint, showing significant cardiovascular risk reductions with bempedoic acid[20](index=20&type=chunk)[21](index=21&type=chunk) - Supplemental New Drug Applications (sNDAs) were submitted to the FDA and a Type II(a) variation application was filed with the EMA to add cardiovascular risk reduction to product labels, with decisions expected in 2024[23](index=23&type=chunk)[24](index=24&type=chunk) - The company is in a legal dispute with its European partner, DSE, regarding its right to receive a **$300 million** milestone payment related to the CLEAR Outcomes trial results[71](index=71&type=chunk)[72](index=72&type=chunk) - In March 2023, the company raised approximately **$52.4 million** in net proceeds through a registered direct offering of common stock, pre-funded warrants, and warrants[22](index=22&type=chunk)[127](index=127&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased revenues, a narrowed net loss due to higher revenue and lower R&D expenses, and a sufficient liquidity position to fund future operations [Results of Operations](index=32&type=section&id=Results%20of%20Operations) For Q3 2023 and the nine-month period, revenue increased, R&D expenses decreased, and SG&A expenses rose, leading to a reduced net loss - **Q3 2023 vs Q3 2022:** - **Product sales, net:** Increased by **$6.3 million** due to prescription growth of NEXLETOL and NEXLIZET[168](index=168&type=chunk) - **Collaboration revenue:** Increased by **$8.7 million** due to higher product sales to partners and royalty growth[169](index=169&type=chunk) - **R&D expenses:** Decreased by **$14.2 million** primarily due to lower costs for the CLEAR Outcomes study[171](index=171&type=chunk) - **SG&A expenses:** Increased by **$8.2 million** due to higher legal and promotional costs[172](index=172&type=chunk) - **Nine Months 2023 vs 2022:** - **Product sales, net:** Increased by **$16.7 million** due to prescription growth[176](index=176&type=chunk) - **Collaboration revenue:** Increased by **$10.7 million** from higher partner sales and royalties[177](index=177&type=chunk) - **R&D expenses:** Decreased by **$17.5 million** due to lower CLEAR Outcomes study costs[179](index=179&type=chunk) - **SG&A expenses:** Increased by **$12.2 million** from higher legal, consulting, and promotional expenses[180](index=180&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company had $114.8 million in cash, supplemented by recent equity offerings, and expects sufficient liquidity for the foreseeable future - The company's primary source of liquidity as of September 30, 2023, was **$114.8 million** in cash and cash equivalents[184](index=184&type=chunk) - During the nine months ended September 30, 2023, the company raised approximately **$4.4 million** net from its 2023 ATM Program and approximately **$52.4 million** net from a registered direct offering and warrant amendments[183](index=183&type=chunk)[193](index=193&type=chunk) - Management believes current cash and expected future revenues are sufficient to fund operations for the foreseeable future[183](index=183&type=chunk)[197](index=197&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) There have been no material changes to the company's market risk disclosures since its 2022 Annual Report on Form 10-K - There have been no material changes with respect to market risk disclosures since the 2022 Annual Report on Form 10-K[200](index=200&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting - As of September 30, 2023, the company's disclosure controls and procedures were deemed effective by management[202](index=202&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[203](index=203&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) Information on legal proceedings, including the dispute with DSE over a $300 million milestone payment, is detailed in Note 5 of the financial statements - Information regarding legal proceedings is detailed in Note 5, "Commitments and Contingencies," of the financial statements[205](index=205&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) New or materially changed risk factors include stock price volatility, potential delisting, delays in FDA/SEC reviews, DSE's failure to perform, and banking system instability - The company's common stock has experienced substantial price volatility and could be delisted from Nasdaq if it fails to meet continuing listing standards, such as the minimum price requirement[209](index=209&type=chunk) - A dispute with partner DSE over a **$300 million** milestone payment is highlighted as a risk. A failure to receive or delay in receiving milestone payments from partners could significantly impact future capital needs[212](index=212&type=chunk) - Inadequate funding or shutdowns of government agencies like the FDA and SEC could hinder their ability to review and approve new products or applications in a timely manner[210](index=210&type=chunk)[211](index=211&type=chunk) - Recent failures of banks and financial institutions pose a risk to the company's ability to access its cash, cash equivalents, and investments, which could adversely affect operations[217](index=217&type=chunk)[218](index=218&type=chunk) [Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the report, including corporate governance documents and required CEO/CFO certifications - The Exhibit Index lists all documents filed with the report, including corporate governance documents and required CEO/CFO certifications[220](index=220&type=chunk)[222](index=222&type=chunk)

Financial Data and Key Metrics Changes - Total revenue for Q2 2023 was $25.8 million, a 37% increase year-over-year [4][34] - U.S. revenue reached $20.3 million, reflecting a 49% year-over-year growth [4][34] - Retail prescription equivalents (RPE) grew 26% year-over-year and 16% quarter-over-quarter [33] - Cash, cash equivalents, and investment securities totaled $138.5 million as of June 30, 2023, down from $166.9 million on December 31, 2022 [34] Business Line Data and Key Metrics Changes - Retail prescription equivalents from NEXLETOL and NEXLIZET increased by 26% year-over-year [13] - New-to-brand prescriptions grew by 60% from ACC presentation to the end of June [13] - Collaboration revenue, including royalties and partner revenue, was $5.5 million, a 4% increase year-over-year [34] Market Data and Key Metrics Changes - In Europe, 123,000 patients have been treated with the therapies, representing a 26% growth since February [22] - The total addressable patient population in the U.S. is expected to increase to approximately 70 million following label expansion [19] Company Strategy and Development Direction - The company is focused on expanding its label to include a broader cardiovascular risk reduction indication [8][19] - A strategic approach is being employed to present relevant analyses to target different segments of the population [14] - The company anticipates significant growth following label expansion and full commercial launch in mid-2024 [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving blockbuster status for NEXLETOL and NEXLIZET, emphasizing the potential to reach more patients [20][38] - Positive feedback from payers has been received, with over 80% of U.S. pharmacy lives represented in discussions [16] - The company is preparing for a significant sales inflection post-label expansion [26] Other Important Information - R&D expenses for Q2 were $22.1 million, a decrease of 32% year-over-year [57] - SG&A expenses were $34 million, an increase of 15% year-over-year, reflecting upfront training costs and higher legal costs [57] - The company has sufficient cash runway through mid-2024, which aligns with expected regulatory approvals [35] Q&A Session Summary Question: What is the status of the April 2024 trial date? - Management expressed confidence that the trial date is set and that they expect a favorable outcome [64][70] Question: How are prescription volumes impacting gross to net? - Management indicated that gross to net has been stable, with increased volumes expected to improve it over the next one to two years [71] Question: Where are the increases in prescriptions coming from? - Increases are seen in both depth and breadth among current prescribers, with a balanced split between primary care and cardiology [74] Question: What is the current status of reimbursement dynamics? - There has been an increase in prior authorization approval rates, with efforts focused on educating offices about the process [106] Question: How is the detailing process being affected by the current label? - The sales team is focusing on the current strategy, with increases attributed to clinician appreciation for the data despite the label not being updated [103]

REACHING GOALS Retail Prescription Equivalents Y/Y • Acceptance of two late-breaker presentations at European Society of Cardiology 2023 in August CVOT © 2023 Esperion. All Rights Reserved – Do not copy or distribute. 7 © 2023 Esperion. All Rights Reserved – Do not copy or distribute. • Primary hyperlipidemia Forward-looking Statements & Disclosures © 2023 Esperion. All Rights Reserved – Do not copy or distribute. Business Update Sheldon Koenig, President and CEO $26M 4 Total Revenue +37% Y/Y +26% Robust Da ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ 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: 001-35986 Esperion Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or o ...

Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q1 2023 Earnings Conference Call May 9, 2023 8:00 AM ET Company Participants Tiffany Aldrich - Associate Director, Corporate Communications Sheldon Koenig - President and Chief Executive Officer Eric Warren - Chief Commercial Officer Benjamin Halladay - Chief Financial Officer JoAnne Foody - Chief Medical Officer Betty Swartz - Chief Strategy Officer Conference Call Participants Dennis Ding - Jefferies Serge Belanger - Needham Jessica Fye - JPMorgan Jason Zemansky - ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ 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: 001-35986 Esperion Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

Financial Data and Key Metrics Changes - The company reported U.S. net product revenue of $15 million for Q4 2022, a 23% increase year-over-year, and $55.9 million for the full year 2022, up approximately 40% year-over-year [4][11] - Total revenue for Q4 2022 was $18.8 million, a 22% increase year-over-year, while total revenue for the full year 2022 decreased by 4% to $75.5 million due to a one-time milestone payment [11] - Cash, cash equivalents, and investment securities totaled $166.9 million as of December 31, 2022, down from $309.3 million a year earlier [6] Business Line Data and Key Metrics Changes - Royalty revenue for Q4 2022 was $2.3 million, up 188% year-over-year, and $6.5 million for the full year, an 81% increase year-over-year [6] - Combined royalty and partner revenue for Q4 2022 was $3.9 million, a 22% increase year-over-year, but decreased by 49% for the full year to $19.6 million due to a prior year milestone payment [7] Market Data and Key Metrics Changes - The partner Daiichi Sankyo reported strong growth for NILEMDO and NUSTENDI in Europe, with over 82,000 patients in November 2022 [5] Company Strategy and Development Direction - The company is focused on expanding patient access and improving prior authorization criteria while preparing for regulatory filings with the FDA and EMA in the first half of 2023 [1] - Plans are underway to scale the commercial organization and transition to a broader promotional approach following the anticipated positive results from the CLEAR Outcomes trial [106] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive impact of the CLEAR Outcomes trial on clinical management for patients at risk for cardiovascular disease [116] - The company is optimistic about achieving broader patient access and reimbursement improvements following recent formulary additions [109] Other Important Information - The company has reduced SG&A expenses by 41% year-over-year, reflecting cost management strategies implemented in 2021 [113] - The upcoming presentation of the CLEAR Outcomes trial results is expected to be a pivotal moment for the company, with significant implications for future growth [106] Q&A Session Summary Question: What is the divergence of the meaning of clinically meaningful between the investment community and the medical communities? - Management emphasized that clinically meaningful results are those that improve patient health and influence prescribing practices, highlighting the differentiation of their drugs [121] Question: How familiar are prescribing physicians with the benefits of hsCRP and glucose control? - Management acknowledged that awareness is lower than desired but noted that exposure to their current profile has had a favorable impact, with significant changes expected following the CVOT data release [80] Question: How is the company thinking about spending on sales moving forward? - Management indicated that while they have managed cash prudently, they are considering ramping up sales efforts in anticipation of increased demand following the CLEAR Outcomes data [64]