Group 1 - Mirum Pharmaceuticals received approval from Health Canada for the tablet formulation of Livmarli to treat cholestatic pruritus in patients with Alagille syndrome (ALGS) [1] - Following the approval announcement, Mirum's shares increased by over 5% in pre-market trading [1] - ALGS is a rare genetic disorder that can cause cholestasis and severe itching due to bile duct abnormalities [1] Group 2 - Livmarli was previously approved in Canada as an oral solution for ALGS patients aged 12 months and older [2] - Health Canada also authorized Livmarli for treating cholestatic pruritus in patients aged 12 months and older with progressive familial intrahepatic cholestasis (PFIC) [2] - Mirum Pharmaceuticals shares closed at $103.96 on Wednesday, reflecting a decrease of 1.41% [2]

Core Viewpoint - Mirum Pharmaceuticals is showing strong performance and growth potential, with shares more than doubling over the past year, but it is not yet consistently profitable [1][2]. Financial Performance - For the first nine months of 2025, Mirum generated $372.4 million in revenue, reflecting a year-over-year increase of 56.8% [3]. - The company reported a loss per share of $0.35 for this period, an improvement from a loss of $1.36 per share in the same period last year [3]. - In Q3 2025, Mirum achieved a net profit of $2.9 million, a significant turnaround from a net loss of $14.2 million in Q3 2024 [4]. Revenue Projections - Mirum expects to achieve $520 million in net product sales for the full 2025 fiscal year, indicating at least a 54.4% growth compared to 2024 [6]. - For 2026, the company is guiding for net sales between $630 million to $650 million, representing a midpoint growth of 23.1% compared to 2025 [6]. Strategic Acquisitions - The company recently acquired Bluejay Therapeutics for $620 million, which may negatively impact short-term profitability due to acquisition costs but is expected to enhance revenue and earnings in the long run [7]. Future Outlook - Mirum has key clinical catalysts that could positively impact its stock price and drive sales growth [8]. - Despite recent strong performance, there are concerns about limited upside potential and the timeline for achieving consistent profitability [8][9].

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]

Summary of Mirum Pharmaceuticals FY Conference Call Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Focus**: Rare disease company delivering life-changing medicines to patients with rare diseases - **Key Products**: Livmarli, Volixibat, Chenodal, Cholbam, Brilovatug Financial Performance - **2025 Product Revenue**: Estimated at $520 million - **2026 Revenue Guidance**: Expected between $630 million and $650 million - **Potential Revenue from Pipeline**: Over $4 billion across current commercial and pipeline programs [3][25] Key Products and Pipeline Livmarli - **Indications**: Approved for Alagille syndrome and PFIC, with a third indication expected to read out later this year - **2025 Revenue**: $359 million, with strong growth driven by pediatric patient starts and label expansion into PFIC [8][30] - **Future Potential**: Estimated billion-plus potential opportunity [6][30] - **EXPAND Study**: Aiming for label expansion into other cholestatic pruritic indications, with top-line data expected in Q4 [10][12] Volixibat - **Indications**: Studied for PSC and PBC, targeting a significant unmet need in cholestatic pruritus [12][13] - **Market Size**: Approximately 30,000 patients with PSC, with two-thirds experiencing pruritus [13] - **Upcoming Data**: Top-line data from the VISTAS study expected next quarter, with NDA filing anticipated in the second half of the year [16][25] Brilovatug (Acquisition of BlueJ Therapeutics) - **Indication**: Targeting hepatitis delta, a rare co-infection with HBV - **Market Size**: Approximately 15,000 diagnosed and insured patients in the U.S., with potential for higher prevalence in other regions [22][48] - **Phase 2 Results**: Achieved 100% virologic response, with a 65%-82% response rate on FDA approval endpoints [23][47] - **Phase 3 Program**: AZURE studies currently enrolling, with top-line data expected in the second half of the year [24][25] Market Dynamics - **Livmarli**: Strong growth driven by increased awareness and diagnosis in adult PFIC settings, with a focus on genetic testing [9][28] - **Volixibat**: Positioned as the only potential therapy for PSC, with a significant market opportunity due to the lack of approved therapies [41][42] - **PBC Market**: More competitive with recent approvals of PPARs, but still presents opportunities for IBAT inhibitors [43] Commercial Strategy - **Geographic Focus**: Direct commercialization in North America and Western Europe, with partnerships in smaller countries [5] - **Field Expansion**: Plans to increase the U.S. field force by 30-40 people to target community physicians and GI specialists [44] Risks and Considerations - **Regulatory Risks**: Ongoing monitoring of clinical trial outcomes and regulatory approvals for pipeline products [2][25] - **Market Competition**: Need to navigate competitive landscapes, especially in the PBC market [42][43] Conclusion - Mirum Pharmaceuticals is positioned for significant growth with a strong pipeline and commercial strategy, focusing on rare diseases and addressing unmet medical needs in cholestatic conditions and hepatitis delta. The company anticipates pivotal data readouts in the coming year that could further enhance its market position and revenue potential [25][26].

Group 1 - TimesSquare Capital Management's "U.S. Small Cap Growth Strategy" reported a gross return of 2.26% and a net return of 2.01% for Q3 2025, significantly underperforming the Russell 2000 Growth Index, which returned 12.19% [1] - All asset classes except fixed income outside the U.S. posted positive returns during the quarter [1] - The fund's top five holdings were highlighted as its best picks for 2025 [1] Group 2 - Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) was noted for a one-month return of 15.54% and a 52-week gain of 79.65%, with a market capitalization of $3.905 billion as of January 5, 2026 [2] - Mirum Pharmaceuticals reported revenue of $133 million in Q3 2025, reflecting a nearly 50% year-over-year increase [3] - The company is developing new applications for its flagship treatment, Livmarli, to address a third indication [3]

Market Predictions for 2026 - The S&P 500 is expected to deliver single-digit gains in 2026, ending a streak of double-digit gains over the past three years, but no major market sell-off is anticipated due to strong economic and corporate earnings [4][5] - Small- and mid-cap stocks are predicted to outperform larger stocks, with Mirum Pharmaceuticals highlighted as a potential winner after its share price nearly doubled in 2025, and expected positive results from clinical studies in 2026 [6][7][8] - The AI sector is expected to shift from hype to tangible returns, with Alphabet predicted to continue benefiting from its Google Cloud unit and agentic AI technology, which is anticipated to drive growth [9][10][12] - The renewable energy sector is expected to continue its rebound, driven by strong AI growth and increased demand for energy to power data centers, with Brookfield Renewable and Clearway Energy expected to perform well [13][15] - Political dynamics in the mid-term election year are expected to create volatility in the stock market, but once the uncertainty fades, stocks are predicted to move higher, with potential winners in the cannabis industry if Democrats gain control [16][18]

Core Viewpoint - Newsmax, despite having over 50 million regular viewers in the U.S., faces significant competition and challenges in the market, particularly from larger players like Fox Corp, and is predicted to underperform compared to other stocks in the next five years [1][2]. Group 1: Newsmax Overview - Newsmax has a market capitalization of approximately $1.1 billion and has recently expanded into Europe and the Middle East, which may increase its audience [1][2]. - The company reported a net loss of $4.1 million in the third quarter of 2025, indicating ongoing profitability challenges [7]. Group 2: Competitor Analysis - Fox Corp - Fox Corp, Newsmax's largest competitor, has a market cap of nearly $31 billion, significantly larger than Newsmax's [4]. - In the latest quarter, Fox reported a profit of $690 million, while Newsmax's revenue growth is in low single-digit percentages [7]. - Fox's shares have a price-to-sales ratio of 1.8, which is more attractive compared to Newsmax's forward sales multiple of 6 [7]. Group 3: Competitor Analysis - Mirum Pharmaceuticals - Mirum Pharmaceuticals has a market cap of around $4 billion and reported a revenue increase of 47% year-over-year in the third quarter, driven by its liver disease drug Livmarli [8][9]. - The company is optimistic about its pipeline, including potential blockbuster drugs and plans to acquire Bluejay Therapeutics, which could enhance its portfolio [11][12]. Group 4: Competitor Analysis - The Trade Desk - The Trade Desk, a leading advertising technology company, has a market cap of $19 billion and is expected to outperform Newsmax in the long term [13][15]. - The Trade Desk's growth opportunities are bolstered by the rise of ad-supported connected TV and international market expansion [15].

Summary of Mirum Pharmaceuticals Conference Call Company Overview - **Company**: Mirum Pharmaceuticals (NasdaqGM:MIRM) - **Acquisition Target**: BlueJ Therapeutics - **Focus**: Rare diseases, specifically Hepatitis Delta Key Points from the Conference Call Acquisition Announcement - Mirum announced a definitive agreement to acquire BlueJ Therapeutics for a total of $620 million, consisting of $250 million in cash and $370 million in stock priced at $71.21 per share, plus up to $200 million in sales-based milestone payments starting at $500 million in annual sales [2][17] - The acquisition aims to expand Mirum's rare disease portfolio and enhance its late-stage pipeline [2][4] Product Details - The acquisition includes tegovibart, an anti-hepatitis B surface antigen monoclonal antibody for chronic hepatitis delta virus, which has shown promising Phase II results [4][5] - Tegovibart has received FDA Breakthrough Therapy and PRIME designations in the EU, indicating its potential to significantly change the standard of care for Hepatitis Delta patients [5][9] Clinical Data - Phase II study results showed a 100% virologic response rate in 47 adults with chronic hepatitis delta, with 65%-82% achieving a composite endpoint of virologic response and ALT normalization [8][9] - The ongoing Phase III Azure program is designed to meet registration requirements in both the U.S. and EU, with final data expected in the second half of 2026 [10][11] Market Opportunity - There are an estimated 40,000 prevalent Delta patients in the U.S. and over 230,000 in the U.S. and EU combined, with a significant number undiagnosed [13][14] - Mirum anticipates a global revenue potential of at least $750 million for tegovibart, with the majority expected to come from the U.S. market [14][42] Commercial Strategy - Mirum plans to leverage its existing commercial infrastructure, which is expected to deliver $500 million-$510 million in sales in 2025, to support the launch of tegovibart [14][17] - The company aims to expand its field teams modestly to cover areas like infectious disease and internal medicine practices where Delta patients are managed [15] Financial Position - Mirum has a solid balance sheet and expects to return to cash flow positive status in 2027, with no change to its 2025 guidance despite the acquisition [17][18] - The acquisition is seen as a disciplined approach to capital allocation, expanding the rare disease portfolio without compromising financial independence [18] Competitive Landscape - The competitive dynamics include the potential entry of Gilead's Hepcludex in the U.S. market, which could enhance market development for Hepatitis Delta [22][24] - Mirum believes that the unique profile of tegovibart, with its high response rates and favorable safety profile, positions it well against competitors [46] Regulatory Path - The Azure One and Azure Four studies are designed to support U.S. registration, with clear buy-in from the FDA [23][55] - The Azure Two and Three studies are superiority studies aimed at supporting EMA registration [61] Future Outlook - Mirum is optimistic about the upcoming catalysts, including four registrational stage readouts in the next 18 months, which could significantly enhance its value creation potential [19][20] Additional Important Points - The acquisition process was competitive, with other interest in BlueJ's program, but Mirum had been following the program for over a year [52] - The company is focused on the Delta program and does not plan to invest in BlueJ's HBV pipeline agents [37] This summary encapsulates the key aspects of the conference call, highlighting Mirum Pharmaceuticals' strategic acquisition, product potential, market opportunity, and future outlook in the rare disease sector.

Core Insights - Mirum Pharmaceuticals is a mid-cap biotech stock that has seen significant gains, with a nearly 70% increase in 2025, and is expected to perform even better in 2026 [2][3] Company Performance - The current market capitalization of Mirum Pharmaceuticals is $4 billion, with a current stock price of $69.88 and a gross margin of 79.85% [3] - Livmarli, one of Mirum's three approved products, is the primary growth driver, with sales increasing by 56% year-over-year in Q3 2025 to $92.2 million, accounting for approximately 69% of total sales [3][4] - Combined sales for Mirum's other two bile acid medicines, Cholbam and Ctexli, rose by 31% year-over-year in Q3 to $40.8 million [6] Product Approvals and Pipeline - Livmarli was first approved by the FDA in September 2021 for treating cholestatic pruritus in patients with Alagille syndrome, a rare genetic disorder [4] - In 2024, Mirum received two additional FDA approvals for Livmarli for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged five years and older, and for a tablet version of Livmarli [5] - The company has two promising pipeline candidates, voloxibat and MRM-3379, which could also contribute significantly to future revenue [8][10] Future Outlook - The introduction of a tablet formulation of Livmarli is expected to enhance sales, with early indications of strong uptake [7] - Mirum anticipates that Livmarli could generate annual sales exceeding $1 billion [8] - Positive topline data from ongoing Phase 2 studies for voloxibat and MRM-3379 could serve as catalysts for further stock performance [9][10]