Mirum Pharmaceuticals (NasdaqGM:MIRM) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsAndrew McKibben - SVP of Strategic Finance and Investor RelationsCharles Wallace - Managing DirectorChris Peetz - CEOEric Bjerkholt - CFOJames Condulis - VP of Biotechnology Equity ResearchJoanne Quan - Chief Medical OfficerJoe Kim - Assistant VPJonathan Wolleben - Managing DirectorJoseph Thome - Managing DirectorRyan Deschner - Director of Equity ResearchConference Call ParticipantsBrian Skorney - ...

Mirum Pharmaceuticals (NasdaqGM:MIRM) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsAndrew McKibben - SVP of Strategic Finance and Investor RelationsCharles Wallace - Managing DirectorChris Peetz - CEOEric Bjerkholt - CFOJames Condulis - VP of Biotechnology Equity ResearchJoanne Quan - Chief Medical OfficerJoe Kim - Assistant VPJon Wolleben - Managing DirectorJoseph Thome - Managing DirectorRyan Deschner - Director of Equity ResearchConference Call ParticipantsBrian Skorney - Senio ...

Mirum Pharmaceuticals (NasdaqGM:MIRM) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Speaker5Good afternoon, and welcome to Mirum Pharmaceuticals' fourth quarter and full year 2025 conference call. My name is Elliot, and I'll be your operator today. All lines are currently in listen-only mode, and there'll be an opportunity for Q&A after management's prepared remarks. I'd now like to hand the conference over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.Speaker0Th ...

Core Viewpoint - Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) is highlighted as one of the best stocks to buy, with a recent price target increase from H.C. Wainwright indicating strong future potential for the company [1][2]. Group 1: Price Target Adjustments - H.C. Wainwright raised its price target on Mirum Pharmaceuticals from $102 to $130, maintaining a Buy rating, marking the second increase in two weeks [1][2]. - The price target revisions are based on bullish guidance for 2026, particularly regarding the clinical evaluation of volixibat in chronic immune-mediated cholestatic liver diseases [2]. Group 2: Clinical Developments - Analysts believe that volixibat could launch as early as the first half of 2027, with the VISTAS study in primary sclerosing cholangitis expected to provide topline data in Q2 2026 [2]. - Enrollment for the VISTAS study is anticipated to be completed in the second half of 2026, indicating a critical timeline for the company's product development [2]. Group 3: Stock Performance and Analyst Ratings - Over the past six months, MIRM shares have increased by over 91%, with all 11 analysts covering the stock rating it as a Buy [3]. - The median price target among analysts is set at $103, suggesting a slight upside of just under 4%, while H.C. Wainwright's target of $130 implies an upside potential of almost 31% [3]. Group 4: Company Overview - Mirum Pharmaceuticals is a biopharmaceutical firm focused on developing and commercializing therapies for rare and orphan diseases [3].

Core Viewpoint - Mirum Pharmaceuticals is positioned for significant growth, with its share price having more than doubled in the past year and expectations for further increases in 2026 due to key developments in its pipeline and financial performance [1]. Financial Performance - Mirum achieved positive cash flow from operations in 2025, marking a significant milestone for the company [2]. - Net product sales for Livmarli increased by 69% year over year in 2025, reaching $359 million, while sales for Cholbam and Ctexli rose by 31% to $161 million. The company anticipates overall revenue guidance of $630 million to $650 million for the current year [5]. Regulatory Approvals - The company received two FDA approvals in the previous year: Ctexli for treating cerebrotendinous xanthomatosis and a tablet formulation of Livmarli for cholestatic pruritus in patients with Alagille syndrome and Progressive Familial Intrahepatic Cholestasis [3]. Pipeline Developments - On January 26, 2026, Mirum completed the acquisition of Bluejay Therapeutics, adding brelovitug to its pipeline, which targets chronic hepatitis delta virus, a rare liver disease with no current approved treatment in the U.S. [4]. - The company is expecting results from a Phase 2B clinical study of volixibat for primary sclerosing cholangitis in the second quarter of 2026, with plans to file for accelerated approval in the second half of the year [6]. - Results from a Phase 3 study of brelovitug for HDV treatment are anticipated in the latter half of 2026, with potential filing for approval in early 2027 if results are positive [8]. - The timing of the Phase 3 study of Livmarli for pruritus in rare cholestatic conditions has been accelerated, with enrollment expected to complete in the first half of 2026 and topline data to be reported by year-end [9].

Core Insights - CorMedix (CRMD) and Mirum Pharmaceuticals (MIRM) attract investors in the rare-disease biotech sector due to smaller patient populations that can yield significant revenue through premium pricing and regulatory incentives [1] - Both companies benefit from clearer clinical endpoints and faster regulatory pathways, allowing quicker market entry compared to traditional drugs [1] CorMedix (CRMD) Overview - CorMedix's lead product, DefenCath, received FDA approval in late 2023 as the first antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in kidney failure patients [2] - DefenCath generated $167.6 million in net sales in the first nine months of 2025, indicating strong market adoption [7] - The company plans to expand DefenCath's label into total parenteral nutrition and has diversified its revenue through a $300 million acquisition of Melinta Therapeutics, adding seven approved therapies to its portfolio [7] - Despite initial success, CorMedix's future outlook is cautious, with 2026 revenue guidance of $300-$320 million and projected 2027 revenues of $100-$140 million, reflecting pricing pressures and limited growth [8][11] Mirum Pharmaceuticals (MIRM) Overview - Mirum's lead product, Livmarli, is approved for treating cholestatic pruritus in patients with Alagille syndrome and has seen a 70% year-over-year increase in net sales, reaching $161.4 million in the first nine months of 2025 [3][12] - The company has expanded its portfolio with a new tablet formulation of Livmarli and additional bile acid products from the acquisition of Travere Therapeutics, generating $118.8 million in the first nine months of 2025 [16] - MIRM's revenue guidance for 2026 is approximately $630-$650 million, supported by a broader product base and ongoing clinical studies for new therapies [16][28] Comparative Analysis - Both companies exhibit a similar risk-reward profile, but MIRM presents a clearer growth narrative with multiple revenue drivers, while CRMD's outlook is clouded by conservative guidance and reliance on a single product [4][9] - MIRM's shares have increased by 75.3% over the past six months, contrasting with CRMD's 38% decline, indicating market preference for MIRM's growth potential [23] - Valuation metrics show MIRM trading at a price/book ratio of 16.02, significantly higher than CRMD's 1.43, reflecting investor confidence in MIRM's growth prospects [24] Investment Recommendation - Mirum Pharmaceuticals is viewed as the better investment opportunity due to its strong sales growth, diversified revenue streams, and multiple growth levers, while CorMedix faces more uncertainty and competitive pressures [25][29]

Core Insights - Mirum Pharmaceuticals (MIRM) shares increased by 7.1% following the announcement of strong preliminary results for Q4 and full-year 2025, which boosted investor confidence [1][6] Financial Performance - Preliminary net product sales for Mirum in 2025 were approximately $520 million, exceeding the management's guidance of $500-$510 million provided in November 2025 [2][6] - Estimated net product sales for Livmarli were around $359 million for 2025, while Cholbam and Ctexli contributed approximately $161 million [4] - For Q4 2025, estimated net product sales were about $149 million, including $106 million from Livmarli and around $43 million from Cholbam and Ctexli [5] 2026 Sales Outlook - Mirum forecasts net product sales of approximately $630-$650 million for 2026 [6][7] - The company is conducting a phase III study for Livmarli aimed at treating pruritus in rare cholestatic conditions, with enrollment expected to complete in the first half of 2026 [7] Pipeline Developments - Mirum's lead pipeline candidate, volixibat, is under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis, with top-line data from the VISTAS study anticipated in Q2 2026 [8] - A definitive agreement to acquire Bluejay Therapeutics was announced in December 2025, which will enhance Mirum's portfolio in rare liver diseases [9] - A phase II study has been initiated for MRM-3379, a PDE4D inhibitor targeting Fragile X syndrome [10]

Core Insights - XOMA Royalty Corporation has amended its collaboration with Takeda, regaining a majority of the royalty interest in mezagitamab while diversifying its portfolio through a strategic royalty share transaction [1][2] Summary by Relevant Sections Collaboration with Takeda - The collaboration, originally established in 2006, has been amended to reduce Takeda's royalty and milestone payment obligations related to mezagitamab [1] - XOMA Royalty will now receive low to mid-single-digit royalties and milestone payments across nine development-stage assets in Takeda's externalized assets portfolio [1][2] Financial Implications - Prior to the amendment, XOMA Royalty held a mid-single-digit royalty and $16.25 million in potential milestones for mezagitamab [3] - Post-amendment, XOMA Royalty will retain a low single-digit royalty entitlement and up to $13.0 million in milestones for mezagitamab [3] Development-Stage Assets - The nine development-stage assets include: - **Osavampator**: Developed by Neurocrine Biosciences for major depressive disorder [4] - **Volixibat**: Developed by Mirum Pharmaceuticals for primary sclerosing cholangitis and primary biliary cholangitis [5] - **OHB-607**: A recombinant human IGF-1/IGFBP-3 for preventing bronchopulmonary dysplasia in premature infants, along with other early-stage assets from Oak Hill Bio [6] - **REC-4881**: An investigational MEK1/2 inhibitor for familial adenomatous polyposis, affecting approximately 50,000 people in the U.S. and Europe [7]

Core Insights - Mirum Pharmaceuticals' revenue is primarily driven by its lead product, Livmarli, which has shown consistent sales growth since its launch [1][3][11] Product Overview - Livmarli is an orally administered IBAT inhibitor approved for treating cholestatic pruritus in patients with Alagille syndrome and certain patients with PFIC in the U.S. and Europe [2] - A new tablet formulation of Livmarli has been approved, enhancing convenience for older patients [3] Financial Performance - In the first nine months of 2025, Livmarli's net product sales reached $253.6 million, reflecting a 70% year-over-year increase [3] - Mirum anticipates total revenues for 2025 to be between $500 million and $510 million, up from a previous estimate of $490 million to $510 million, driven by Livmarli and bile acid products [6] Product Portfolio Expansion - Mirum has made progress with other marketed products, Cholbam and Ctexli, which were added to its portfolio following the acquisition of Travere Therapeutics' bile acid products in 2023 [5][6] Pipeline Developments - Mirum's lead pipeline candidate, volixibat, is currently under evaluation in two phase IIb studies for primary biliary cholangitis and primary sclerosing cholangitis [7] Competitive Landscape - Mirum faces competition from Albireo AB's Bylvay, which directly competes with Livmarli in the PFIC and ALGS markets [9] - GSK is developing linerixibat, another IBAT inhibitor, which could pose significant competition for Mirum's pipeline candidate volixibat [10][12] Stock Performance and Valuation - Over the past six months, Mirum's shares have increased by 35.9%, outperforming the industry and the S&P 500 [13] - The company's shares are trading at a premium, with a price/book ratio of 11.87 compared to the industry average of 3.55 [14] Earnings Estimates - The Zacks Consensus Estimate for Mirum's 2025 loss per share has narrowed from 67 cents to 41 cents, while estimates for 2026 have shifted from earnings of 4 cents per share to a loss of 29 cents [15]

Core Insights - Mirum Pharmaceuticals Inc. is identified as a high short interest stock with significant investment potential, particularly following the acquisition of Bluejay and the addition of the drug brelovitug to its pipeline [1][3] - The company reported a strong Q3 2025 earnings performance, with quarterly revenue reaching $133 million, reflecting a ~50% year-over-year increase and a positive net income of ~$3 million [2][3] Financial Performance - Q3 2025 revenue totaled $133 million, marking a ~50% increase year-over-year [2] - The primary revenue driver was product sales, with LIVMARLI net product sales at $92 million, including $64 million from the US and $28 million from international sales [2] - Additional sales from Bile Acid Medicines contributed $41 million to net product sales [2] Strategic Developments - Morgan Stanley raised the price target for Mirum Pharmaceuticals to $95 from $81, citing the strategic significance of the Bluejay acquisition and the promising potential of brelovitug in treating hepatitis delta virus [1][3] - The acquisition is expected to enhance the company's rare liver disease pipeline and create valuable synergies [1] Market Challenges - Despite strong performance, the company faces commercial variability, particularly with international sales of LIVMARLI due to large periodic orders from distributors [3] - Management anticipates a sequential decline in revenue for Q4 and does not expect additional sales to its partner, Takeda, in Japan during that quarter [3] - There is ongoing uncertainty regarding the pricing strategy for the investigational drug volixibat as the company analyzes market dynamics [3]