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Mirum(MIRM) - 2022 Q4 - Annual Report
2023-03-08 21:16
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, 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 001-38981 Mirum Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) | Delaware | 83-1281555 | | --- | --- | | (S ...
Mirum Pharmaceuticals (MIRM) Investor Presentation - Slideshow
2023-01-11 18:43
Corporate Presentation We use our website (www.mirumpharma.com), LinkedIn page (www.linkedin.com/company/mirum-pharmaceuticals), and Twitter account (https://twitter.com/mirumpharma) as channels of distribution of information about our company, product candidates, planned announcements, attendance at upcoming conferences and other matters. Such information may be deemed material information and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors shou ...
Mirum(MIRM) - 2022 Q3 - Earnings Call Transcript
2022-11-09 21:12
Financial Data and Key Metrics Changes - Mirum Pharmaceuticals reported net sales of $47.2 million for LIVMARLI year-to-date, with an estimated $70 million in net product sales expected for 2022, indicating a strong first full year of approval [7][10] - The company raised its full-year net product sales guidance for LIVMARLI to $70 million, reflecting a 20% quarter-over-quarter growth from Q3 to Q4 [10][64] Business Line Data and Key Metrics Changes - LIVMARLI's net sales for Q3 2022 were $18.8 million, showing continued quarterly growth [10][11] - The company observed high levels of compliance and persistence with LIVMARLI, maintaining strong reimbursements [10] Market Data and Key Metrics Changes - Mirum received a positive CHMP opinion for LIVMARLI in Europe for the treatment of cholestatic pruritus and Alagille syndrome, with launches planned in key European countries in 2023 [8] - Over 130 Alagille patients outside the U.S. are currently receiving LIVMARLI through clinical and expanded access programs [13] Company Strategy and Development Direction - The company aims to expand its market presence internationally, with Germany set to be the first European country to launch LIVMARLI in Q1 2023 [12] - Mirum is focused on leveraging the positive results from the MARCH-PFIC Phase III study to support regulatory submissions and further market expansion [59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the acceleration of new patient starts for LIVMARLI, attributing previous revenue growth deceleration to seasonal factors [64] - The management team highlighted the importance of ongoing clinical data and patient feedback in shaping future strategies and product offerings [59][90] Other Important Information - The MARCH-PFIC Phase III study enrolled 93 PFIC patients, marking it as the largest PFIC study conducted, with significant improvements observed in pruritus and serum bile acids [16][50] - The study results indicated that maralixibat could produce both biologically and clinically significant improvements, particularly in pruritus and serum bile acids across various PFIC types [50][52] Q&A Session Summary Question: Acceleration of new starts on LIVMARLI and revenue growth deceleration - Management noted an acceleration in new patient starts in the fall, which they believe will contribute to revenue growth despite summer softness due to seasonal factors [64] Question: Differences between LIVMARLI and Bylvay - Professor Thompson indicated that while both drugs show significant response rates, a direct head-to-head comparison has not been conducted, and individual patient factors will influence treatment decisions [65][66] Question: Patient dynamics and growth going forward - Management confirmed no significant changes in patient demographics, with consistent age and body weight among new patients [79] Question: Comparability with Bylvay and efficacy calculations - Management stated that while they cannot make definitive cross-study comparisons, their data shows consistent results across various measurement times [85] Question: Critical results from MARCH-PFIC for label adoption - Professor Thompson emphasized the importance of understanding the response rates and maintaining long-term responses in patients as critical for label adoption [95]
Mirum Pharmaceuticals (MIRM) Investor Presentation - Slideshow
2022-09-13 14:22
Corporate Presentation September 2022 Forward-Looking Statements This presentation contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, objectives and opportunities. Forward- looking statements are subject to known and unknown risks, u ...
Mirum(MIRM) - 2022 Q2 - Earnings Call Transcript
2022-08-07 12:00
Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Ian Clements - CFO Chris Peetz - President and CEO Peter Radovich - COO Pam Vig - Head, R&D Conference Call Participants Jessica Fye - JPMorgan Lili Nsongo - SVB Ed Arce - H.C. Wainright Ryan Deschner - Raymond James Operator Good afternoon. My name is Chris, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Mirum Q2 2022 Business Update. [Oper ...
Mirum(MIRM) - 2022 Q2 - Quarterly Report
2022-08-04 20:33
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, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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: 001-38981 Mirum Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 83-1281555 ( ...
Mirum(MIRM) - 2022 Q1 - Earnings Call Transcript
2022-05-07 20:18
Mirum Pharmaceuticals Inc. (NASDAQ:MIRM) Q1 2022 Results Conference Call May 5, 2022 8:30 AM ET Company Participants Chris Peetz - President, CEO Ian Clements - CFO Peter Radovich - COO Pam Vig - Head, R&D Conference Call Participants Ed Arce - H.C. Wainwright Brian Skorney - Baird Nick Lenard - JPMorgan Josh Schimmer - Evercore Rick Bienkowski - SVB Ryan Deschner - Raymond James Yasmeen Rahimi - Piper Sandler Operator Hello, and welcome to the Mirum Pharmaceuticals first quarter business update. My name is ...
Mirum(MIRM) - 2022 Q1 - Earnings Call Presentation
2022-05-06 16:35
LIVMARLI for Alagille Syndrome (ALGS) - LIVMARLI is FDA-approved for cholestatic pruritus in ALGS patients [7], with a potential market opportunity exceeding $500 million in the US [7, 9] - A 6-year analysis demonstrated a 70% reduction in clinical outcomes (liver transplantation, biliary diversion surgery, hepatic decompensation, or death) with LIVMARLI compared to an untreated cohort [21] - Q1 2022 total product net revenue for LIVMARLI was $10.9 million, with approximately 75% of dispenses reimbursed [9] Pipeline and Development - The company has 5 late-stage indications under development [7, 12], including Progressive Familial Intrahepatic Cholestasis (PFIC), Biliary Atresia, Primary Sclerosing Cholangitis (PSC), Intrahepatic Cholestasis of Pregnancy (ICP), and Primary Biliary Cholangitis (PBC) [12] - MARCH Phase 3 data for PFIC is expected in Q4 2022 [12, 47, 80] - EMBARK study data for Biliary Atresia is expected in 2023 [12, 55, 80] - Interim data for VISTAS (PSC) and OHANA (ICP) are expected in Q4 2022, with VANTAGE (PBC) interim data expected in 2023 [12, 59, 80] Volixibat for Adult Cholestasis - Volixibat is being targeted for adult cholestasis, including ICP, PSC, and PBC [58, 59] - There are approximately 40,000 ICP cases per year in the US [59] - There are approximately 130,000 PBC cases per year in the US [59] Financial Status - The company reported $12.9 million net revenue in Q1 2022, with $10.9 million in net product revenue [78] - The company has a strong balance sheet with $239.9 million as of March 31, 2022 [78]
Mirum(MIRM) - 2022 Q1 - Quarterly Report
2022-05-05 20:07
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) The company reported first Livmarli sales of **$10.9 million**, total revenue of **$12.9 million**, and a net loss of **$36.6 million** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$278.1 million** from **$294.7 million**, with a corresponding reduction in liabilities Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $46,272 | $31,340 | | Short-term investments | $93,636 | $125,201 | | Total current assets | $155,268 | $166,592 | | Total assets | $278,148 | $294,651 | | **Liabilities & Equity** | | | | Total current liabilities | $34,553 | $42,596 | | Revenue interest liability, net | $132,940 | $129,923 | | Total liabilities | $169,216 | $174,439 | | Total stockholders' equity | $108,932 | $120,212 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported first product sales of **$10.9 million**, total revenue of **$12.9 million**, and a net loss of **$36.6 million** Statement of Operations Summary (in thousands, except per share data) | Line Item | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | | :--- | :--- | :--- | | Product sales, net | $10,892 | $— | | License revenue | $2,000 | $— | | **Total revenue** | **$12,892** | **$—** | | Cost of sales | $2,424 | $— | | Research and development | $24,088 | $38,134 | | Selling, general and administrative | $19,116 | $9,479 | | **Total operating expenses** | **$45,628** | **$47,613** | | Loss from operations | ($32,736) | ($47,613) | | **Net loss** | **($36,606)** | **($50,532)** | | Net loss per share, basic and diluted | ($1.17) | ($1.68) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash outflow was **$39.7 million**, with net cash increasing by **$14.9 million** from investing and financing Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($39,669) | ($25,210) | | Net cash provided by (used in) investing activities | $36,500 | ($32,784) | | Net cash provided by financing activities | $18,104 | $6,594 | | **Net increase (decrease) in cash** | **$14,932** | **($51,409)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail business, accounting policies, FDA approval of Livmarli, liquidity, and financing arrangements - The company received **FDA approval for LIVMARLI® (maralixibat) on September 29, 2021**, for treating **cholestatic pruritus in Alagille syndrome (ALGS) patients** aged one year and older[29](index=29&type=chunk) - Management believes that its unrestricted cash, cash equivalents, and investments of **$139.9 million** as of March 31, 2022, are **sufficient to fund operations for at least the next twelve months**[31](index=31&type=chunk) - The company has a Revenue Interest Purchase Agreement (RIPA) with an affiliate of Oberland Capital, under which it has received **$115.0 million** in financing. In return, the Purchasers receive tiered revenue interest payments based on annual net sales of Livmarli, starting at **9.75%**[63](index=63&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) - In January 2022, a regulatory milestone was achieved by partner CANbridge, triggering a **$2.0 million milestone payment** to the company, which was recorded as license revenue[81](index=81&type=chunk) - During Q1 2022, the company sold **995,897 shares of common stock** through its "at the market" (ATM) sales agreement, raising net proceeds of **approximately $17.4 million**[89](index=89&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Livmarli's commercial launch, a reduced net loss of **$36.6 million**, and sufficient liquidity - The company's lead product, Livmarli, is approved in the U.S. for **cholestatic pruritus in Alagille syndrome (ALGS) patients**. The company is also developing Livmarli for **Progressive Familial Intrahepatic Cholestasis (PFIC)** and **Biliary Atresia (BA)**, and its second product candidate, **volixibat, for adult cholestatic liver diseases**[111](index=111&type=chunk)[112](index=112&type=chunk) Results of Operations Comparison (in thousands) | | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | Change | | :--- | :--- | :--- | :--- | | **Total revenue** | **$12,892** | **$—** | **$12,892** | | Cost of sales | $2,424 | $— | $2,424 | | Research and development | $24,088 | $38,134 | ($14,046) | | Selling, general and administrative | $19,116 | $9,479 | $9,637 | | **Net Loss** | **($36,606)** | **($50,532)** | **$13,926** | - The **$14.0 million decrease in R&D expenses** was primarily due to a **$17.0 million decrease in license fees** (milestone payments) compared to the prior year. This was partially offset by increased clinical trial expenses for volixibat programs and higher personnel costs[149](index=149&type=chunk)[151](index=151&type=chunk) - The **$9.6 million increase in SG&A expenses** was driven by a **$4.9 million increase in personnel costs** (including **$1.4 million in stock-based compensation**), a **$2.9 million increase in professional services** for commercial launch, and a **$1.8 million increase in other administrative expenses**[150](index=150&type=chunk) - The company believes its cash, unrestricted cash equivalents, and investments will be **sufficient to fund current operations for at least the next 12 months** from the filing date of the report[155](index=155&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks include interest rate sensitivity, variable RIPA interest rates, and minor foreign currency exposure - The company's primary market risk is interest rate sensitivity on its cash and investment portfolio, but due to the short-term nature of its instruments, a **100-basis-point change in interest rates is not expected to have a material impact**[174](index=174&type=chunk) - The effective interest rate on the **Revenue Interest Purchase Agreement (RIPA) liability may vary based on forecasts of net product sales**, which could materially impact interest expense recognized each period[175](index=175&type=chunk) - **Foreign currency risk from operations in Switzerland and contracts denominated in Swiss Francs and Euros is not currently considered significant**[176](index=176&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective with no material changes in internal controls - The company's management, including the CEO and CFO, concluded that as of March 31, 2022, the company's **disclosure controls and procedures were effective**[178](index=178&type=chunk) - **No changes in internal control over financial reporting occurred during the first quarter of 2022** that have materially affected, or are reasonably likely to materially affect, the company's internal controls[180](index=180&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any legal proceedings expected to materially affect its financial condition - **Management believes there are currently no pending claims or actions against the company that would have a material adverse effect** on its results of operations, financial condition, or cash flows[183](index=183&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) Key risks include Livmarli commercialization, manufacturing reliance, financing, and intellectual property protection - The success of the business depends on the **continued successful commercialization of Livmarli, its only FDA-approved product**[185](index=185&type=chunk) - The company has **limited marketing and sales experience** and **relies completely on third parties for manufacturing, including sole-source suppliers**[187](index=187&type=chunk)[208](index=208&type=chunk) - The company has a **limited operating history, has incurred significant losses since inception, and expects to continue incurring losses for the foreseeable future**[217](index=217&type=chunk) - **Substantial additional financing will be needed** to continue commercialization, develop product candidates, and implement operating plans. Failure to obtain financing could force delays or elimination of programs[343](index=343&type=chunk) - The company is **dependent on intellectual property licensed from third parties**, and **termination of these licenses could result in the loss of significant rights**[331](index=331&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - **None**[459](index=459&type=chunk) [Defaults Upon Senior Securities](index=84&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable - **Not applicable**[460](index=460&type=chunk) [Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable - **Not applicable**[461](index=461&type=chunk) [Other Information](index=84&type=section&id=Item%205.%20Other%20Information) No other information to report for the period - **None**[462](index=462&type=chunk) [Exhibits](index=85&type=section&id=Item%206.%20Exhibits) This section lists exhibits including corporate documents, CEO/CFO certifications, and XBRL data files - The exhibits filed include **CEO and CFO certifications pursuant to Sarbanes-Oxley Act Sections 302 and 906, and Inline XBRL documents**[464](index=464&type=chunk)
Mirum Pharmaceuticals (MIRM) Investor Presentation - Slideshow
2022-03-22 11:58
Corporate Presentation March 2022 Forward-Looking Statements This presentation contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, objectives and opportunities. Forward- looking statements are subject to known and unknown risks, uncer ...