BioMarin Pharmaceutical(BMRN)
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BioMarin Pharmaceutical(BMRN) - 2025 Q2 - Earnings Call Transcript
2025-08-04 21:32
Financial Data and Key Metrics Changes - Total revenues grew 16% in Q2 2025 and 15% year-over-year compared to the same periods in 2024, driven by strong global demand and new patient starts [13][19] - Non-GAAP diluted earnings per share increased to $1.44, reflecting a growth rate more than three times that of revenue growth [18] - Operating cash flow reached $185 million in Q2, a 55% increase compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - VOXZOGO revenue increased 20% year-over-year to $221 million, supported by global expansion and new patient starts [13][20] - Enzyme Therapies revenue rose 15% year-over-year to $555 million, with Palynziq and Vimizim contributing significantly to growth [15][26] - Rocadian revenue was $9 million in Q2, primarily from the U.S. and Italy [15] Market Data and Key Metrics Changes - The company expects second half VOXZOGO revenue to be higher than the first half, with full-year revenue guidance adjusted to between $900 million and $935 million [14][15] - The company anticipates continued strong growth in the second half of 2025, leading to an increase in full-year guidance for total revenues [11][19] Company Strategy and Development Direction - The company plans to advance BMN 333, a long-acting therapy for achondroplasia, to a registrational Phase 2/3 study in the first half of next year [9][28] - The acquisition of Inozyme broadens the enzyme therapies portfolio, with a focus on BMN 401 for ENPP1 deficiency [10][31] - The company aims to augment its portfolio with strategic business development transactions to diversify growth strategies [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong growth and value creation for stakeholders through the remainder of 2025 and beyond [11][19] - The management highlighted the essential nature of their medicines and strong patient support programs as key factors in maintaining availability for patients [26] Other Important Information - The company expects to account for the Inozyme acquisition as an asset purchase, impacting financial results in 2025 [19] - The company is on track to submit applications for age extension for Palynziq to include adolescents in the U.S. and EU in the second half of this year [30] Q&A Session Summary Question: Clarification on BMN 333 and safety profile - Management confirmed that the agent referred to is Trans Con CNP and stated that no unexpected safety issues have been observed in the healthy volunteer study [36][38] Question: Thoughts on competitive landscape for achondroplasia - Management noted that while early data showed added growth with growth hormone, long-term benefits remain uncertain, and further data is needed to assess the impact of combinations [42][45] Question: Contributions to VOXZOGO guidance - Management explained that the adjustment in guidance is primarily due to shifting large orders and a better understanding of revenue trends as the year progresses [50][52] Question: Update on ITC proceedings - Management expects the initial determination from the ITC on June 8, 2026, with a completion date targeted for October 8, 2026 [56][58] Question: Details on BMN 333 trial design - Management refrained from providing specific details on powering but expressed confidence in the biological hypothesis being tested [58][60] Question: Update on citizen petition with the FDA - Management stated that the FDA is reviewing the citizen petition and no updates are expected until the PDUFA date of November 30 [88][90]
BioMarin Pharmaceutical(BMRN) - 2025 Q2 - Earnings Call Transcript
2025-08-04 21:30
Financial Data and Key Metrics Changes - Total revenues grew 16% in Q2 2025 and 15% year over year compared to the same periods in 2024, driven by strong global demand and new patient starts [12][18] - Non-GAAP diluted earnings per share increased to $1.44, reflecting a growth rate more than three times that of revenue growth [17] - Operating cash flow reached $185 million in Q2, a 55% increase compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - VOXZOGO revenue increased 20% year over year to $221 million, supported by global expansion and new patient starts [12][20] - Enzyme Therapies revenue rose 15% year over year to $555 million, with Palynziq and Vimizim contributing significantly to growth [14][28] - Rocadian revenue was $9 million in Q2, primarily from the U.S. and Italy [14] Market Data and Key Metrics Changes - The company expects second half VOXZOGO revenue to be higher than the first half, with a full year target of $900 million to $935 million [13][14] - The company anticipates continued strong growth throughout the remainder of 2025, leading to an increase in full year guidance for total revenues [9][19] Company Strategy and Development Direction - The company plans to advance BMN 333, a long-acting therapy for achondroplasia, to a registrational Phase 2/3 study in the first half of 2026 [7][31] - The acquisition of Inozyme broadens the enzyme therapies portfolio, with BMN 401 expected to address ENPP1 deficiency [8][35] - The company aims to diversify its growth strategy through strategic business development transactions [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong growth and value creation for stakeholders through 2025 and beyond [10][19] - The management highlighted the importance of patient adherence and support programs to maintain high compliance rates [66][68] Other Important Information - The company expects to account for the Inozyme acquisition as an asset purchase, impacting financial results in 2025 [19] - The company is on track to submit applications for Palynziq to include adolescents in the U.S. and EU in the second half of 2025 [32] Q&A Session Summary Question: Clarification on BMN 333 and safety profile - Management confirmed that the agent referred to is TransCon CNP and stated that no unexpected safety issues have been observed in the healthy volunteer study [39][40] Question: Thoughts on competitive landscape for achondroplasia - Management noted that while early data shows growth hormone combinations may provide short-term increases, long-term benefits remain uncertain [44][45] Question: Contributions to VOXZOGO guidance - Management explained that the adjustment in guidance is due to order timing and a better understanding of trends as the year progresses [48][50] Question: Update on ITC proceedings - Management expects initial determination from the ITC on June 8, 2026, with a completion date targeted for October 8, 2026 [53][54] Question: Details on BMN 333 superiority trial design - Management refrained from providing specific details on powering but expressed confidence in the biological hypothesis being tested [56][58] Question: Update on hypochondroplasia and patient enrollment - Management emphasized the importance of early diagnosis and treatment for hypochondroplasia, leveraging existing relationships to raise awareness [100][101]
BioMarin Pharmaceutical(BMRN) - 2025 Q2 - Earnings Call Presentation
2025-08-04 20:30
Financial Performance - Total Revenues for Q2 2025 reached $825 million, a 16% year-over-year increase[17, 22] - VOXZOGO revenue in Q2 2025 was $221 million, representing a 20% year-over-year growth[17, 22] - Enzyme Therapies revenue in Q2 2025 was $555 million, a 15% year-over-year increase[17, 22] - Non-GAAP Operating Margin for Q2 2025 was 39.9%, an increase of 8.7 percentage points year-over-year[25] - Non-GAAP Diluted EPS for Q2 2025 was $1.44, a 50% increase year-over-year[17, 30] - Operating Cash Flow for Q2 2025 was $185 million, a 55% increase year-over-year[30] - The company increased FY'25 Total Revenues guidance to $3,125 million to $3,200 million[24, 34] - The company increased FY'25 Non-GAAP Diluted EPS guidance to $4.40 to $4.55[33, 34] Product and Pipeline Updates - VOXZOGO's contribution to full-year 2025 Total Revenues is expected to be in the range of $900 million to $935 million[24, 34] - BMN 333 Phase 1 data showed >3x AUC PK free CNP levels vs other long-acting CNP[17, 45] - Submissions for PALYNZIQ age eligibility expansion for adolescents (12-17 y/o) in the U S and Europe are planned for 2H 2025[3, 48, 51, 56]
BioMarin Pharmaceutical(BMRN) - 2025 Q2 - Quarterly Results
2025-08-04 20:04
Financial Performance - Total Revenues for Q2 2025 were $825 million, a 16% increase year-over-year, driven by a 20% growth in VOXZOGO revenue[8]. - GAAP Net Income rose to $241 million, reflecting a 125% increase compared to Q2 2024, primarily due to higher gross profit and lower SG&A expenses[12]. - Non-GAAP Diluted EPS for Q2 2025 was $1.44, a 50% increase year-over-year, while GAAP Diluted EPS was $1.23, up 124%[12]. - Total revenues for Q2 2025 reached $825.4 million, a 15.9% increase from $712.0 million in Q2 2024[27]. - Net product revenues for Q2 2025 were $813.0 million, up from $702.1 million in Q2 2024, reflecting a growth of 15.9%[27]. - Net income for the six months ended June 30, 2025, was $426.2 million, a 117% increase from $195.8 million in 2024[33]. - Total revenues for the six months ended June 30, 2025, increased by $210 million, or 15%, compared to the same period in 2024[39]. - Non-GAAP income for the six months ended June 30, 2025, was $502 million, up from $329 million in 2024, reflecting a 52% increase[39]. - Non-GAAP diluted EPS for the six months ended June 30, 2025, was $2.57, compared to $1.67 in 2024, marking a 54% increase[41]. Cash Flow and Liquidity - Operating cash flows totaled $185 million in Q2 2025, a 55% increase from the same period in 2024, supporting future growth investments[15]. - Cash and cash equivalents as of June 30, 2025, were $1.21 billion, compared to $942.8 million at the end of 2024, indicating a significant liquidity improvement[31]. - Cash and cash equivalents at the end of the period increased to $1.21 billion in 2025 from $972.2 million in 2024[33]. - Net cash provided by operating activities increased to $359.7 million in 2025 from $165.7 million in 2024, representing a 117% growth[33]. Revenue Guidance and Projections - The company raised its full-year 2025 guidance for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS, reflecting strong patient demand[15]. - Non-GAAP diluted EPS for 2025 is projected to be between $4.40 and $4.55, up from the previous guidance of $4.20 to $4.40[17]. - Non-GAAP operating margin for 2025 is expected to be between 33% and 34%, an increase from the previous estimate of 32% to 33%[17]. - The contribution of VOXZOGO to total revenues for 2025 is expected to be in the range of $900 million to $935 million[17]. Product Development and Acquisitions - BioMarin completed the acquisition of Inozyme on July 1, 2025, enhancing its portfolio with BMN 401 for ENPP1 Deficiency treatment[5]. - BMN 333, a long-acting CNP treatment for achondroplasia, showed promising Phase 1 data and is set to enter pivotal studies in 2026[8]. - BioMarin expects to submit applications to expand PALYNZIQ age eligibility in the U.S. and Europe in the second half of 2025, with potential approval in 2026[11]. - The company anticipates initial pivotal data for BMN 401 in the first half of 2026, with a potential launch in 2027[8]. - BioMarin plans to expand VOXZOGO into more than 60 countries by 2027, indicating a strategic market expansion[24]. - The acquisition of Inozyme Pharma, completed on July 1, 2025, is expected to impact future financial results, with updates to be provided in Q3 2025 earnings[19]. Expenses and Financial Adjustments - Research and development (R&D) expenses for the six months ended June 30, 2025, were $320 million, compared to $389 million in 2024, a decrease of 18%[41]. - Selling, general and administrative (SG&A) expenses for the six months ended June 30, 2025, were $438 million, down from $489 million in 2024, a decrease of 10%[41]. - The company reported a non-GAAP operating margin of 37.9% for the six months ended June 30, 2025, compared to 27.6% in 2024[41]. - The company experienced a favorable impact of foreign currency exchange rates, with a $21 million adjustment for the six months ended June 30, 2025[39]. - The company incurred severance and restructuring costs related to its 2024 corporate initiatives, included in SG&A[42]. - Impairment loss on non-marketable equity securities was recorded in Other income (expense), net[42]. - A payment was triggered by a third party's attainment of a regulatory approval milestone related to previously sold intangible assets[42]. Shareholder Information - Non-GAAP Weighted-Average Diluted Shares Outstanding for Q2 2025 were 197.1 million, compared to 200.5 million in Q2 2024[43]. - For the six months ended June 30, 2025, Non-GAAP Weighted-Average Diluted Shares Outstanding were 196.6 million, down from 200.1 million in the same period of 2024[43].
BioMarin Reports Strong Second Quarter 2025 Results and Raises Full-year Guidance¹ for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS
Prnewswire· 2025-08-04 20:02
Financial Performance - Total Revenues for Q2 2025 were $825 million, representing a 16% increase year-over-year, driven by a 20% growth in VOXZOGO revenue from new patients [5][12][13] - GAAP Net Income increased by $134 million to $241 million, a 125% increase compared to Q2 2024, primarily due to higher gross profit and lower SG&A expenses [5][13][14] - Non-GAAP Income rose by $93 million to $282 million, reflecting a 49% growth year-over-year [5][13][14] Earnings Per Share - GAAP Diluted EPS for Q2 2025 was $1.23, a 124% increase year-over-year [5][13][14] - Non-GAAP Diluted EPS was $1.44, representing a 50% increase compared to the same period in 2024 [5][13][14] Business Development - The acquisition of Inozyme was completed on July 1, 2025, enhancing the company's portfolio with BMN 401 for ENPP1 Deficiency treatment [4][5][13] - BMN 333, a potential treatment for achondroplasia, showed promising early data and is expected to enter pivotal studies in 2026 [3][4][9] Pipeline Progress - VOXZOGO revenue increased by 20% year-over-year, with treatment available for children with achondroplasia in 51 countries [9][10][12] - The company is advancing its CANOPY clinical program for VOXZOGO in additional indications, with pivotal study data expected in 2026 [9][10][12] Operational Efficiency - GAAP Operating Margin expanded to 33.5%, a 16.6 percentage point increase year-over-year, while Non-GAAP Operating Margin reached 39.9%, an 8.7 percentage point increase [13][14] - R&D expenses decreased year-over-year due to focused investment following a strategic portfolio review [13][14] Cash Flow and Guidance - Operating cash flows totaled $185 million in Q2 2025, a 55% increase compared to the same period in 2024 [13][14] - The company raised its full-year 2025 guidance for Total Revenues, Non-GAAP Operating Margin, and Non-GAAP Diluted EPS, reflecting continued growth in patient demand [13][17]
BioMarin Announces Appointment of Ian T. Clark to Board of Directors
Prnewswire· 2025-08-01 13:00
Core Insights - BioMarin Pharmaceutical Inc. has appointed Ian T. Clark to its Board of Directors effective August 1, 2025 [1] - Ian T. Clark previously served as CEO of Genentech, where he led the launch of 15 new drugs [2] - Clark has extensive experience in the biopharmaceutical industry, having held senior roles at Novartis, Sanofi, Ivax Pharmaceuticals, and G.D. Searle [2] - The addition of Clark is expected to bring valuable perspective to BioMarin, enhancing its ability to develop new therapies for patients with unmet needs [3] Company Overview - BioMarin is a global biotechnology company focused on developing medicines for rare and difficult-to-treat genetic conditions [4] - Founded in 1997 and based in San Rafael, California, BioMarin has a strong track record with eight commercial therapies and a robust clinical and preclinical pipeline [4] - The company aims to translate genetic discoveries into impactful medicines for patients worldwide [4]
BioMarin Pharmaceutical (BMRN) Reports Next Week: Wall Street Expects Earnings Growth
ZACKS· 2025-07-28 15:06
Wall Street expects a year-over-year increase in earnings on higher revenues when BioMarin Pharmaceutical (BMRN) reports results for the quarter ended June 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on August 4, might help the stock move higher if these key numbers are better than ...
Looking for a Growth Stock? 3 Reasons Why BioMarin (BMRN) is a Solid Choice
ZACKS· 2025-07-16 17:46
Core Viewpoint - Growth investors are increasingly focused on stocks with above-average financial growth, but identifying stocks that can sustain this growth is challenging [1] Group 1: Company Overview - BioMarin Pharmaceutical (BMRN) is highlighted as a recommended growth stock due to its favorable Growth Score and top Zacks Rank [2][10] Group 2: Earnings Growth - BioMarin has a historical EPS growth rate of 40.9%, with projected EPS growth of 23% this year, surpassing the industry average of 19.7% [5][4] Group 3: Cash Flow Growth - The year-over-year cash flow growth for BioMarin is 83.6%, significantly higher than the industry average of -4.7% [6] - The company's annualized cash flow growth rate over the past 3-5 years is 40.1%, compared to the industry average of 4.1% [7] Group 4: Earnings Estimate Revisions - Current-year earnings estimates for BioMarin have been revised upward, with the Zacks Consensus Estimate increasing by 0.1% over the past month [8] Group 5: Investment Potential - BioMarin has achieved a Growth Score of B and a Zacks Rank 1, indicating it is a potential outperformer and a solid choice for growth investors [10]
Wall Street Analysts Think BioMarin (BMRN) Could Surge 70.77%: Read This Before Placing a Bet
ZACKS· 2025-07-16 14:56
Core Viewpoint - BioMarin Pharmaceutical (BMRN) shows potential for significant upside, with a mean price target of $96.69 indicating a 70.8% increase from the current price of $56.62 [1] Price Targets and Estimates - The mean estimate consists of 26 short-term price targets, with a standard deviation of $14.53, indicating variability among analysts [2] - The lowest estimate is $65.00, suggesting a 14.8% increase, while the highest estimate is $122.00, indicating a potential surge of 115.5% [2] - A low standard deviation among price targets suggests a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates - Analysts have shown increasing optimism about BMRN's earnings prospects, with a strong consensus in revising EPS estimates higher [11] - Over the last 30 days, one estimate has increased, leading to a 0.1% rise in the Zacks Consensus Estimate [12] - BMRN holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [13] Analyst Behavior and Price Target Reliability - Analysts often set overly optimistic price targets due to business incentives, which can lead to inflated estimates [8] - While price targets can provide some guidance, they should be approached with skepticism, as they may not accurately reflect future stock movements [10]
Nasdaq Bull Market: 3 Historically Cheap Stocks That Can Easily Double Your Money
The Motley Fool· 2025-07-16 07:51
Core Viewpoint - The article identifies three undervalued stocks with strong potential for significant returns in a high-priced stock market environment, particularly within the Nasdaq bull market. Group 1: Sirius XM Holdings - Sirius XM operates as a legal monopoly in satellite radio, providing it with substantial subscription pricing power [7] - The company generates over 77% of its net sales from subscriptions, making its cash flow more stable compared to traditional advertising revenue [9] - Shares are currently valued at approximately 8.1 times forecast earnings per share (EPS) for 2026, significantly lower than its five-year average of 13.71, along with a 4.7% dividend yield [11] Group 2: BioMarin Pharmaceutical - BioMarin focuses on ultrarare diseases, which allows for high margins due to limited competition and high list prices [15] - The company's leading drug, Voxzogo, is projected to generate over $900 million in sales in 2025, contributing to a forecast of at least $4 billion in total sales by 2027, up from $2.85 billion in 2024 [17] - BioMarin shares are trading at 10.8 times forward-year EPS, a 67% discount from its average forward-year earnings multiple over the past five years [18] Group 3: Goodyear Tire & Rubber - The tire industry is cyclical, with historical recessions being short-lived, which benefits long-term demand for tires [20] - Goodyear is actively selling noncore assets to improve operational efficiency, including the sale of the Dunlop brand for $735 million and its off-the-road tire business for $905 million [22] - Shares are available at approximately 5.7 times forecast EPS for 2026, representing a 29% discount to its average forward P/E multiple since 2020 [24]