BridgeBio Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Commercial Update

- As of February 17, 2025, 1,028 unique patient prescriptions for Attruby™ have been written by 516 unique prescribers since FDA approval - Attruby (acoramidis), the first and only near-complete TTR stabilizer (≥90%) was approved by the FDA to reduce cardiovascular death and cardiovascular-related hospitalization in ATTR-CM patients on November 22, 2024 - Acoramidis was approved as BEYONTTRA™ in the EU on February 10, 2025, achieving a $75 million milestone payment and ongoing royalties in a tiered structure beginning in the low-thirties percent on sales in the EU - Acoramidis demonstrated a 59% hazard reduction on the composite endpoint of all-cause mortality and first cardiovascular-related hospitalization in the variant ATTR-CM population by month 30; to the Company's knowledge, this benefit is the largest and the only statistically significant result in this patient population, which has an aggressive phenotype and poor prognosis - Fully enrolled three global registrational studies – FORTIFY (BBP-418 for LGMD2I/R9), CALIBRATE (encaleret for ADH1), and PROPEL 3 (infigratinib for achondroplasia) – with last participant – last visit expected for each study before the end of 2025 - The Company ended the fourth quarter with $681 million in cash, cash equivalents, and short-term restricted cash. Further, the Company expects to receive $105 million in regulatory milestones in 1H 2025 from acoramidis Europe and Japan approvals PALO ALTO, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases announced today its financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on Attruby’s commercial progress. Commercial Progress: As of February 17, 2025, 1,028 unique patient prescriptions for Attruby have been written by 516 unique healthcare providers since FDA approval. ”I am very encouraged by the strength of the Attruby launch, with prescriptions being successfully filled across all patient types,” said Matt Outten, Chief Commercial Officer of BridgeBio. “In conversations with healthcare providers and patients, we have repeatedly heard that Attruby's category-leading results - time to separation of just three months, along with a 42% reduction in all-cause mortality and recurrent hospitalizations and a 50% reduction in cardiovascular hospitalizations at 30 months - set it apart as a clinically meaningful advancement for ATTR-CM. Combined with our industry-leading patient support programs, we believe Attruby is delivering a much-needed change in the treatment landscape.” Pipeline Overview: ProgramStatusNext expected milestone Acoramidis for ATTR-CMApproved in U.S. and EUJapan approval in 1H 2025BBP-418 for LGMD2I/R9 FORTIFY, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Encaleret for ADH1CALIBRATE, Phase 3 study enrollment completed Last Participant – Last Visit and Topline results in 2H 2025Infigratinib for achondroplasiaPROPEL 3, Phase 3 study enrollment completed Last Participant – Last Visit in 2H 2025Infigratinib for hypochondroplasiaACCEL, run-in for Phase 2 study ongoingEnrollment completion date to be announcedBBP-812 for Canavan diseaseCANaspire Phase 1/2 study ongoingEnrollment completion date to be announced Key Program Updates: “It is exciting to see patients, physicians, and payers resonate with our message that the greater levels of TTR stabilization that Attruby delivers can be of benefit to the patients we serve and that the TTR protein is clinically important, not toxic.” said Neil Kumar, Ph.D., Founder and CEO of BridgeBio. “We look forward to continuing to partner with the community to ensure that we find all patients that can be helped and ease their path to getting on therapy, when appropriate, as much as possible.” Attruby (acoramidis) – the first approved, near-complete (≥90%) TTR stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): On November 22, 2024, the U.S. Food and Drug Administration (FDA) approved Attruby (acoramidis), a near-complete TTR stabilizer (≥90%), to reduce cardiovascular death and cardiovascular-related hospitalization (CVH) in adult patients with ATTR-CM.On February 10, 2025, the European Commission approved BEYONTTRA (acoramidis) for use in adult patients with ATTR-CM in the EU.Preliminary results from the ongoing ATTRibute-CM open-label extension (OLE) study of Attruby in ATTR-CM were simultaneously published in Circulation and presented at the American Heart Association Scientific Sessions, showing that Attruby demonstrated statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at month 36 within the OLE, and 46% (p<0.0001) and 48% (p<0.0001) reductions in the composite endpoint of ACM and recurrent CVH at months 36 and 42, respectively.Attruby is supported by industry-leading access programs designed to ensure seamless treatment initiation and continuity for all patients with ATTR-CM. BBP-418 – Glycosylation substrate in development for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9): FORTIFY, the Phase 3 clinical trial of BBP-418 in LGMD2I/R9, a rare genetic disorder caused by variants in the fukutin‑related protein (FKRP) gene, is fully enrolled with 112 participants. The trial is the largest prospective interventional study to ever be conducted in LGMD2I.The Company expects to achieve last participant – last visit and report topline results of the interim analysis cohort in the second half of 2025.If successful, we expect BBP-418 would be the first approved therapy for individuals living with LGMD2I/R9. Encaleret – Calcium-sensing receptor (CaSR) antagonist in development for autosomal dominant hypocalcemia type 1 (ADH1) and postsurgical hypoparathyroidism (PSH): CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, a genetic form of hypoparathyroidism, is fully enrolled with 71 participants. The trial is the largest prospective interventional study to ever be conducted in ADH1.The Company expects to achieve last participant – last visit and report topline results in the second half of 2025.If successful, we expect encaleret would be the first approved therapy indicated for individuals living with ADH1.A Phase 2 study of encaleret in PSH is ongoing, with preliminary evidence suggestive of a differentiated profile for encaleret in PSH. Infigratinib – FGFR1-3 inhibitor in development for achondroplasia and hypochondroplasia: PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, the most common form of disproportionate short stature, is fully enrolled with 114 participants randomized.The Company expects to achieve last participant – last visit in the second half of 2025.In November 2024, the Phase 2 PROPEL 2 study of infigratinib in children with achondroplasia was published in the New England Journal of Medicine.If successful, we expect infigratinib would be the first approved oral therapy option for children living with achondroplasia.The Company is currently enrolling the ACCEL run-in for a Phase 2 study of infigratinib in hypochondroplasia. Financial Updates: Cash, Cash Equivalents, and Short-term Restricted Cash Cash, cash equivalents and short-term restricted cash, totaled $681.2 million as of December 31, 2024, compared to $392.6 million of cash, cash equivalents and short-term restricted cash as of December 31, 2023. The $288.6 million net increase in cash, cash equivalents and short-term restricted cash was primarily attributable to net proceeds received from the Funding Agreement of $488.8 million, net proceeds received from the term loan under the credit facility of $434.0 million, net proceeds received from various equity financings of $314.7 million, proceeds from the sale of investments in equity securities of $63.2 million, and special cash dividends received from investments in equity securities of $25.7 million. These increases in cash, cash equivalents and short-term restricted cash were primarily offset by the impacts of net cash used in operating activities of $520.7 million, refinancing the Company’s previous senior secured credit term loan, inclusive of prepayment fees and exit-related costs in aggregate of $473.4 million, purchases of equity securities of $20.3 million, Funding Agreement transaction related costs of $16.3 million, and the repurchase of shares to satisfy tax withholdings of $7.5 million during the year ended December 31, 2024. Revenue Revenue for the three months and year ended December 31, 2024, was $5.9 million and $221.9 million, respectively, as compared to $1.7 million and $9.3 million for the same periods in the prior year. The increase of $4.2 million in revenue for the three months ended December 31, 2024, compared to the same period in the prior year, was primarily due to the recognition of $2.9 million in net product revenue from the first commercial sales of Attruby in the U.S. following the FDA approval on November 22, 2024, and services revenue received under the exclusive license and collaboration agreements with Bayer and Kyowa Kirin. Revenue for the three months ended December 31, 2023, primarily consisted of the recognition of services revenue under the Navire-BMS License Agreement, which terminated in June 2024. The increase of $212.6 million in revenue for the year ended December 31, 2024, compared to the same period in the prior year, was primarily due to $207.7 million from recognition of the upfront payments and service revenue under the Bayer and the Kyowa Kirin exclusive license and collaboration agreements, and $2.9 million in net product revenue from the first commercial sales of Attruby following the FDA approval on November 22, 2024. Operating Costs and Expenses Operating costs and expenses for the three months and year ended December 31, 2024, were $231.9 million and $814.9 million, respectively, compared to $179.2 million and $616.7 million for the same periods in the prior year. The overall increase of $52.7 million, in operating costs and expenses for the three months ended December 31, 2024, compared to the same period in the prior year, was primarily due to an increase of $47.2 million in selling, general and administrative (SG&A) expenses mainly to support commercialization of Attruby, which included costs incurred for marketing, advertising and hiring of a sales force in the U.S., an increase of $3.9 million in restructuring, impairment and related charges, and an increase of $1.6 million in research and development (R&D) expenses to advance the Company’s pipeline of R&D programs. The overall increase of $198.2 million, in operating costs and expenses for the year ended December 31, 2024, compared to the same period in the prior year, was primarily due to an increase of $138.3 million in SG&A expenses related to costs primarily to support the commercial launch of Attruby which included costs incurred for marketing, advertising and hiring of a sales force in the U.S., an increase of $52.2 million in R&D expenses to advance the Company’s pipeline of R&D programs, and an increase of $7.7 million in restructuring, impairment and related charges. Operating costs and expenses for the year ended December 31, 2024, include $25.0 million of nonrecurring deal-related costs for transactions that were completed during the year ended December 31, 2024. Restructuring, impairment and related charges for the three months and year ended December 31, 2024, amounted to $4.7 million and $15.6 million, respectively. These charges primarily consisted of impairments and write-offs of long-lived assets, severance and employee-related costs, and exit and other related costs. Restructuring, impairment, and related charges for the same periods in the prior year were $0.8 million and $7.9 million, respectively. These charges primarily consisted of winding down, exit costs, and severance and employee-related costs. Stock-based compensation expenses included in operating costs and expenses for the three months ended December 31, 2024, were $36.4 million, of which $20.0 million is included in R&D expenses, $16.3 million is included in SG&A expenses, and less than $0.1 million is included in restructuring, impairment, and related charges. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $37.1 million, of which $22.5 million is included in R&D expenses, and $14.6 million is included in SG&A expenses. Stock-based compensation expenses included in operating costs and expenses for the year ended December 31, 2024, were $113.9 million, of which $63.9 million is included in SG&A expenses, $49.8 million is included in R&D expenses, and $0.2 million is included in restructuring, impairment and related charges. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $115.0 million, of which $61.6 million is included in R&D expenses, and $53.4 million is included in SG&A expenses. Total Other Income (Expense), net Total other income (expense), net for the three months and year ended December 31, 2024, were ($40.2) million and $50.8 million, respectively, compared to $7.1 million and ($45.9) million for the same periods in the prior year. The increase in total other expense, net of $47.3 million for the three months ended December 31, 2024, compared to the same period in the prior year, was primarily due to a decrease in other income, net of $20.1 million mainly due to market fair value adjustments from the Company’s investments in equity securities, a net loss from equity method investments of $16.7 million, an increase in interest expense, net of $9.6 million, and a decrease in interest income of $0.9 million. The increase in total other income, net of $96.7 million for the year ended December 31, 2024 , compared to the same period in the prior year, was primarily due to gains the Company recognized on the deconsolidation of subsidiaries of $178.3 million. These gains were partially offset by recognition a net loss from equity method investments of $31.2 million, a loss on extinguishment of debt of $26.6 million, an increase in interest expense, net of $18.0 million, a decrease in other income, net of $5.0 million mainly due to market fair value adjustments from the Company’s investments in equity securities, and a decrease in interest income of $0.8 million. Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share For the three months and year ended December 31, 2024, the Company recorded a net loss attributable to common stockholders of BridgeBio of $265.1 million and $535.8 million, respectively, compared to $168.1 million and $643.2 million, respectively, for the three months and year ended December 31, 2023. For the three months and year ended December 31, 2024, the Company reported a net loss per share of $1.40 and $2.88, respectively, compared to $0.96 and $3.95, respectively, for the three months and year ended December 31, 2023. BRIDGEBIO PHARMA, INC.Condensed Consolidated Statements of Operations(in thousands, except shares and per share amounts) Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 (Unaudited) (1) (Unaudited) (1) Revenue, net $5,882 $1,745 $221,902 $9,303 Operating costs and expenses: Research, development and other expenses 132,434 130,824 510,339 458,157 Selling, general and administrative 94,782 47,583 288,931 150,590 Restructuring, impairment and related charges 4,693 754 15,605 7,926 Total operating costs and expenses 231,909 179,161 814,875 616,673 Loss from operations (226,027) (177,416) (592,973) (607,370) Other income (expense), net: Interest income 4,683 5,578 17,249 18,038 Interest expense, net (29,821) (20,268) (99,290) (81,289) Gain on deconsolidation of subsidiaries — — 178,321 — Loss on extinguishment of debt — — (26,590) — Net loss from equity method investments (16,695) — (31,183) — Other income (expense), net 1,624 21,778 12,272 17,370 Total other income (expense), net (40,209) 7,088 50,779 (45,881) Loss before income taxes (266,236) (170,328) (542,194) (653,251) Income tax expense 1,153 — 1,153 — Net loss (267,389) (170,328) (543,347) (653,251) Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests 2,339 2,180 7,585 10,049 Net loss attributable to common stockholders of BridgeBio $(265,050) $(168,148) $(535,762) $(643,202) Net loss per share, basic and diluted $(1.40) $(0.96) $(2.88) $(3.95) Weighted-average shares used in computing net loss per share, basic and diluted 189,437,438 174,462,332 186,075,873 162,791,511 Three Months Ended December 31, Year Ended December 31, Stock-based Compensation 2024 2023 2024 2023 (Unaudited) (1) (Unaudited) (1) Research, development and other expenses $20,004 $22,495 $49,844 $61,647 Selling, general and administrative 16,351 14,638 63,862 53,369 Restructuring, impairment and related charges 79 — 160 — Total stock-based compensation $36,434 $37,133 $113,866 $115,016 BRIDGEBIO PHARMA, INC.Condensed Consolidated Balance Sheets(In thousands) December 31, December 31, 2024 2023 (Unaudited) (1) Assets Cash and cash equivalents $681,101 $375,935 Investments in equity securities — 58,949 Accounts receivable 4,722 1,751 Short-term restricted cash 126 16,653 Prepaid expenses and other current assets 34,743 24,305 Investment in nonconsolidated entities 143,747 — Property and equipment, net 7,011 11,816 Operating lease right-of-use assets 5,767 8,027 Intangible assets, net 23,926 26,319 Other assets 18,195 22,625 Total assets $919,338 $546,380 Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit Accounts payable $9,618 $10,655 Accrued and other liabilities 125,672 122,965 Operating lease liabilities 9,202 13,109 Deferred revenue 31,699 9,823 2029 Notes, net 738,872 736,905 2027 Notes, net 545,173 543,379 Term loan, net 437,337 446,445 Deferred royalty obligation, net 479,091 — Other long-term liabilities 286 5,634 Redeemable convertible noncontrolling interests 142 478 Total BridgeBio stockholders' deficit (1,467,904) (1,354,257) Noncontrolling interests 10,150 11,244 Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit $919,338 $546,380 (1)The condensed consolidated financial statements as of and for the year ended December 31, 2023 are derived from the audited consolidated financial statements as of that date. BRIDGEBIO PHARMA, INC.Condensed Consolidated Statements of Cash Flows(In thousands) Year Ended December 31, 2024 2023 (Unaudited) (1) Operating activities: Net loss $(543,347) $(653,251) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 95,800 108,710 Loss on extinguishment of debt 26,590 — Accretion of debt 15,763 8,907 Depreciation and amortization 6,075 6,494 Noncash lease expense 4,110 4,032 Accrual of payment-in-kind interest on term loan — 10,207 Net loss from equity method investments 31,183 — Loss (gain) on deconsolidation of subsidiaries (178,321) 1,241 Loss (gain) from investment in equity securities, net (8,136) (18,314) Impairment of long-lived assets 271 — Other noncash adjustments, net (2,756) (803) Changes in operating assets and liabilities: Accounts receivable (2,971) 15,328 Prepaid expenses and other current assets (13,918) (2,702) Other assets 1,542 (1,546) Accounts payable 1,512 2,780 Accrued compensation and benefits 16,986 7,802 Accrued research and development liabilities 8,729 (9,855) Operating lease liabilities (5,902) (4,829) Deferred revenue 21,875 (5,438) Accrued professional and other liabilities 4,189 3,517 Net cash used in operating activities (520,726) (527,720) Investing activities: Purchases of marketable securities (93,811) (29,726) Maturities of marketable securities 95,000 82,550 Purchases of investments in equity securities (20,271) (107,538) Proceeds from sales of investments in equity securities 63,229 110,556 Proceeds from special cash dividends received from investments in equity securities 25,682 — Payment for an intangible asset (7,975) — Purchases of property and equipment (933) (1,306) Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries (140) (503) Net cash provided by investing activities 60,781 54,033 Financing activities: Proceeds from royalty obligation under Funding Agreement 500,000 — Issuance costs and discounts associated with royalty obligation under Funding Agreement (27,513) — Proceeds from term loan under Amended Financing Agreement 450,000 — Issuance costs and discounts associated with term loan under Amended Financing Agreement (15,986) — Repayment of term loans (473,417) — Proceeds from issuance of common stock through public offerings, net 314,741 449,810 Proceeds from BridgeBio common stock issuances under ESPP 4,502 3,398 Proceeds from stock option exercises, net of repurchases 3,656 6,008 Transactions with noncontrolling interests — (801) Repurchase of RSU shares to satisfy tax withholding (7,526) (6,880) Net cash provided by financing activities 748,457 451,535 Net increase (decrease) in cash, cash equivalents and restricted cash 288,512 (22,152) Cash, cash equivalents and restricted cash at beginning of year 394,732 416,884 Cash, cash equivalents and restricted cash at end of year $683,244 $394,732 Year Ended December 31, 2024 2023 (Unaudited) (1) Supplemental Disclosure of Cash Flow Information: Cash paid for interest $91,342 $61,108 Supplemental Disclosures of Noncash Investing and Financing Information: Unpaid property and equipment $279 $100 Transfers to noncontrolling interests $(5,819) $(10,534) Reconciliation of Cash, Cash Equivalents and Restricted Cash: Cash and cash equivalents $681,101 $375,935 Restricted cash 126 16,653 Restricted cash — Included in “Other assets” 2,017 2,144 Total cash, cash equivalents and restricted cash at end of period shown in the consolidated statements of cash flows $683,244 $394,732 About Attruby™ (acoramidis) INDICATION Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATION Adverse Reactions Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BEYONTTRA™ (acoramidis) On 10 February 2025, the European Commission granted Marketing Authorization for BEYONTTRA™ (acoramidis) for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). For full prescribing information, please refer to the Summary of Product Characteristics (SmPC). About BridgeBio Pharma, Inc. BridgeBio Pharma (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter and Facebook. BridgeBio Pharma, Inc. Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates”, “believes” “continues”, “estimates”, “expects”, “hopes”, “intends”, “may”, “plans”, “projects”, “remains”, “seeks”, “should”, “will”, and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to our expectations regarding the commercial success of Attruby; our clinical trials, including the timing of the last participant-last visit and topline data readouts for each of FORTIFY, CALIBRATE and PROPEL 3; the potential for encaleret to become a new treatment for ADH1; the potential for BBP-418 to become a new treatment for LGMD2I/R9; the potential for infigratinib to become a new treatment for achondroplasia; timing of approval of Attruby for ATTR-CM in Japan; and our anticipated funding of our current operations and related timelines; and our expectations regarding reaching regulatory milestones and receipt of milestone payments, among others, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for our product candidates, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, our ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in our share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact: Bubba Murarka, EVP Communications contact@bridgebio.com(650)-789-8220

BridgeBio Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Commercial Update

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