BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update
BridgeBio Pharma reported its Q2 2024 financial results, focusing on significant clinical trial progress and financial updates. Acoramidis demonstrated a 42% reduction in composite CVH and ACM events by Month 30, with improvements starting by Month 3. Infigratinib showed +2.50 cm/yr annualized height velocity at Month 18 in Cohort 5 of the PROPEL 2 study. The company exceeded its enrollment target for the Phase 3 FORTIFY study of BBP-418 in LGMD2I/R9. Financially, BridgeBio ended the quarter with $587M in cash, driven by various financing activities. Revenue for the quarter was $2.2M, up from $1.6M in the same period last year, primarily due to collaborations with Bayer and Kyowa Kirin. Operating costs increased to $177.7M, leading to a net loss per share of $0.39, an improvement from $0.98 in Q2 2023.
BridgeBio Pharma ha riportato i risultati finanziari per il secondo trimestre del 2024, ponendo l'accento sui significativi progressi nelle sperimentazioni cliniche e sugli aggiornamenti finanziari. Acoramidis ha dimostrato una riduzione del 42% degli eventi CVH e ACM compositi entro il Mese 30, con miglioramenti già visibili a partire dal Mese 3. Infigratinib ha mostrato un aumento annualizzato della velocità di crescita in altezza di +2,50 cm/anno al Mese 18 nel Gruppo 5 dello studio PROPEL 2. L’azienda ha superato il proprio obiettivo di arruolamento per lo studio di Fase 3 FORTIFY di BBP-418 in LGMD2I/R9. Dal punto di vista finanziario, BridgeBio ha chiuso il trimestre con 587 milioni di dollari in cassa, grazie a varie attività di finanziamento. Le entrate per il trimestre sono state di 2,2 milioni di dollari, in aumento rispetto a 1,6 milioni di dollari nello stesso periodo dell'anno scorso, principalmente a causa delle collaborazioni con Bayer e Kyowa Kirin. I costi operativi sono aumentati a 177,7 milioni di dollari, portando a una perdita netta per azione di 0,39 dollari, in miglioramento rispetto a 0,98 dollari nel Q2 2023.
BridgeBio Pharma informó sobre sus resultados financieros del segundo trimestre de 2024, centrando la atención en los significativos avances en ensayos clínicos y actualizaciones financieras. Acoramidis demostró una reducción del 42% en los eventos CVH y ACM compuestos para el mes 30, con mejoras que comenzaron en el mes 3. Infigratinib mostró una velocidad de crecimiento en altura anualizada de +2,50 cm/año en el mes 18 del Grupo 5 del estudio PROPEL 2. La compañía superó su objetivo de reclutamiento para el estudio de fase 3 FORTIFY de BBP-418 en LGMD2I/R9. Financiera, BridgeBio terminó el trimestre con 587 millones de dólares en efectivo, impulsada por diversas actividades de financiación. Los ingresos del trimestre fueron de 2,2 millones de dólares, un aumento respecto a 1,6 millones en el mismo periodo del año pasado, principalmente debido a colaboraciones con Bayer y Kyowa Kirin. Los costos operativos aumentaron a 177,7 millones de dólares, resultando en una pérdida neta por acción de 0,39 dólares, una mejora respecto a 0,98 dólares en el Q2 2023.
BridgeBio Pharma는 2024년 2분기 재무 결과를 발표했으며, 주요 임상 시험 진행 상황과 재무 업데이트에 중점을 두었습니다. Acoramidis는 30개월 차에 CVH 및 ACM 사건의 복합 감소가 42%에 이르렀으며, 3개월 차부터 개선이 시작되었습니다. Infigratinib은 PROPEL 2 연구의 5번째 집단에서 18개월 차에 연간 +2.50 cm의 신장 속도를 보였습니다. 이 회사는 LGMD2I/R9의 BBP-418에 대한 3상 FORTIFY 연구에서 등록 목표를 초과 달성했습니다. 재무적으로 BridgeBio는 다양한 자금 조달 활동로 5억 8천 7백만 달러의 현금을 보유하며 분기를 종료했습니다. 분기 수익은 220만 달러로, 작년 같은 기간의 160만 달러에서 증가했으며, 이는 주로 Bayer 및 Kyowa Kirin과의 협업 덕분입니다. 운영 비용은 1억 7천 7백 만 달러로 증가하여 주당 순 손실은 0.39달러로 나타났고, 이는 2023년 2분기의 0.98달러에서 개선된 수치입니다.
BridgeBio Pharma a publié ses résultats financiers du deuxième trimestre 2024, en mettant l'accent sur les progrès significatifs des essais cliniques et les mises à jour financières. Acoramidis a montré une réduction de 42% des événements CVH et ACM composites d'ici le mois 30, avec des améliorations commençant dès le mois 3. Infigratinib a montré une vitesse de croissance en hauteur annualisée de +2,50 cm/an au mois 18 dans le groupe 5 de l'étude PROPEL 2. L'entreprise a dépassé son objectif d'inscription pour l'étude de phase 3 FORTIFY de BBP-418 dans LGMD2I/R9. D'un point de vue financier, BridgeBio a terminé le trimestre avec 587 millions de dollars de liquidités, grâce à diverses activités de financement. Les revenus du trimestre étaient de 2,2 millions de dollars, en hausse par rapport à 1,6 million de dollars à la même période de l'année dernière, principalement grâce à des collaborations avec Bayer et Kyowa Kirin. Les coûts d'exploitation ont augmenté à 177,7 millions de dollars, entraînant une perte nette par action de 0,39 dollar, une amélioration par rapport à 0,98 dollar au T2 2023.
BridgeBio Pharma hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und sich auf bedeutende Fortschritte in klinischen Studien sowie auf finanzielle Updates konzentriert. Acoramidis zeigte eine Reduktion von 42% bei den zusammengesetzten CVH- und ACM-Ereignissen bis zum Monat 30, mit Verbesserungen, die bereits im Monat 3 begannen. Infigratinib zeigte eine annualisierte Wachstumsrate in der Höhe von +2,50 cm/Jahr im Monat 18 in Kohorte 5 der PROPEL 2-Studie. Das Unternehmen überschritt sein Rekrutierungsziel für die Phase-3-Studie FORTIFY von BBP-418 bei LGMD2I/R9. Finanzielle Aspekte: BridgeBio beendete das Quartal mit 587 Millionen Dollar in bar, was durch verschiedene Finanzierungsaktivitäten unterstützt wurde. Der Umsatz für das Quartal betrug 2,2 Millionen Dollar, ein Anstieg von 1,6 Millionen Dollar im gleichen Zeitraum des Vorjahres, hauptsächlich aufgrund von Kooperationen mit Bayer und Kyowa Kirin. Die Betriebskosten stiegen auf 177,7 Millionen Dollar, was zu einem Nettoverlust pro Aktie von 0,39 Dollar führte, eine Verbesserung gegenüber 0,98 Dollar im Q2 2023.
- Acoramidis demonstrated a 42% reduction in CVH and ACM events by Month 30.
- Infigratinib showed +2.50 cm/yr AHV at Month 18 in Cohort 5.
- Exceeded enrollment target for Phase 3 FORTIFY study of BBP-418 in LGMD2I/R9.
- Ended Q2 with $587M in cash, up from $392.6M at the end of 2023.
- Revenue increased to $2.2M from $1.6M in the same period last year.
- Net loss per share improved to $0.39 from $0.98 in Q2 2023.
- Operating costs increased to $177.7M from $147.7M in Q2 2023.
- Reported a net loss of $73.5M, despite improved per-share loss metrics.
Insights
BridgeBio Pharma's Q2 2024 results reveal significant progress in their pipeline, particularly with their lead candidate acoramidis for ATTR-CM. The company reported
Revenue for the first half of 2024 surged to
However, operating expenses also rose significantly to
The net loss attributable to common stockholders decreased to
Overall, while BridgeBio is still operating at a loss, the company's financial position has improved significantly, with increased cash reserves and revenue. The focus now shifts to the potential approval and launch of acoramidis, which could be a game-changer for the company's financial outlook.
BridgeBio's Q2 2024 update showcases promising advancements across their pipeline, particularly for their lead candidate acoramidis. The drug demonstrated significant benefits in ATTR-CM patients, including a
The company also reported positive data for infigratinib in achondroplasia, with a statistically significant +2.50 cm/yr annualized height velocity at Month 18 in the Phase 2 PROPEL 2 study. This was accompanied by the first-ever reported statistically significant improvement in body proportionality, a important outcome for patients.
BridgeBio is advancing multiple late-stage programs, including Phase 3 trials for encaleret in ADH1, BBP-418 in LGMD2I/R9 and infigratinib in achondroplasia. The company has also initiated an observational study for infigratinib in hypochondroplasia, expanding its potential indications.
The breadth and progress of BridgeBio's pipeline, particularly in rare genetic diseases, is impressive. With potential readouts from three Phase 3 programs in 2025, the company is positioned for significant clinical milestones in the near future. The focus on genetic diseases with high unmet needs could lead to transformative therapies for patients and potentially lucrative market opportunities.
BridgeBio's Q2 2024 results and pipeline updates position the company favorably in the competitive landscape of rare disease therapeutics. The standout performer, acoramidis for ATTR-CM, has shown compelling efficacy data that could potentially differentiate it in the market. With a PDUFA date set for November 29, 2024, acoramidis could soon transition from a development-stage asset to a commercial product, marking a significant milestone for BridgeBio.
The company's diversified pipeline, spanning multiple rare genetic diseases, provides a hedge against clinical and regulatory risks. The advancement of three programs to Phase 3 trials (encaleret, BBP-418 and infigratinib) demonstrates the company's ability to progress candidates through the development pipeline efficiently.
Infigratinib's potential in both achondroplasia and hypochondroplasia is particularly noteworthy. The statistically significant improvement in body proportionality could be a key differentiator in the market, potentially addressing an unmet need in skeletal dysplasia treatment.
BridgeBio's focus on genetic diseases aligns with current trends in precision medicine and targeted therapies. The potential for Priority Review Vouchers for multiple programs adds another layer of value, either for accelerating future BridgeBio programs or as assets for potential sale.
While the company is still operating at a loss, the significant increase in revenue and cash reserves provides a stronger financial foundation for upcoming commercial activities and continued R&D efforts. The next 12-18 months will be important for BridgeBio as it transitions towards becoming a commercial-stage company with the potential launch of acoramidis.
- Acoramidis demonstrated a significant impact on mortality, hospitalizations, and quality of life
- Starting at Month 3, patients taking acoramidis showed meaningful and sustained improvement in time to first event (CVH or ACM)
- Acoramidis demonstrated a
42% reduction in composite CVH and ACM events relative to placebo by Month 30 - Increased serum TTR levels by Day 28 were correlated with a reduced risk of events (ACM, CVM, and CVH) through Month 30
- Acoramidis resulted in a statistically significant reduction in ACM in the intention-to-treat (ITT) population at Month 30
- Shared +2.50 cm/yr annualized height velocity (AHV) at Month 18 in Cohort 5 of PROPEL 2, the Phase 2 study of infigratinib in achondroplasia, as well as the first ever reported statistically significant improvement in body proportionality
- The first child consented in ACCEL, the observational run-in study for infigratinib in children living with hypochondroplasia, a skeletal dysplasia closely related to achondroplasia
- The Company surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
- The Company ended the quarter with
$587 million in cash, cash equivalents, marketable securities and short-term restricted cash
PALO ALTO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases, today reported its financial results for the second quarter ended June 30, 2024, and provided an update on the Company’s operations.
“Our team has continued its preparation for the commercial launch of acoramidis while also executing against our goal of fully enrolling our three Phase 3 clinical programs by the end of 2024. We are well positioned to launch acoramidis and achieve three readouts in 2025. Our differentiated capability to develop multiple candidates for genetic-based diseases provides a unique opportunity to create significant value for patients and shareholders,” said Dr. Neil Kumar, CEO and Founder of BridgeBio.
Pipeline overview:
| Program | Status | Next expected milestone |
| Acoramidis for ATTR-CM | NDA filed with FDA | November 29, 2024 PDUFA date |
| Encaleret for ADH1 | Enrolling CALIBRATE, Phase 3 study | Enrollment completion in 2024 |
| BBP-418 for LGMD2I/R9 | Enrolling FORTIFY, Phase 3 study | Enrollment completion in 2024 |
| Low-dose infigratinib for achondroplasia | Enrolling PROPEL 3, Phase 3 study | Enrollment completion in 2024 |
| Low-dose infigratinib for hypochondroplasia | Enrolling observational run-in for ACCEL 2, Phase 2 study | Enrollment completion date to be announced |
| BBP-631 for congenital adrenal hyperplasia (CAH) | Dose finding / analysis in Phase 2 study | Program update in August 2024 |
| BBP-812 for Canavan disease | Enrolling at high dose in Phase 1/2 study | Key regulatory interactions |
Program updates:
- Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):
- During the 2024 International Symposium of Amyloidosis (ISA), five new analyses were disclosed through oral presentations and posters, discussing the following:
- Acoramidis treatment resulted in increased serum transthyretin (TTR) levels by Day 28 that were sustained and were correlated with a reduced risk of all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular hospitalization (CVH) in ATTR-CM participants through Month 30.
- Acoramidis treatment resulted in a significant improvement in the composite endpoint of ACM and CVH in ATTR-CM participants, with benefit evident as early as Month 3.
- In ATTRibute-CM, participants with at least one CVH had a significantly higher risk of mortality, highlighting the need for ATTR-CM treatments that reduce the risk of CVH.
- BridgeBio also shared the rationale and design of ACT-EARLY, the acoramidis ATTR amyloidosis prevention trial, which it expects to initiate later this year.
- At this year’s European Society of Cardiology Heart Failure (ESC-HF) Congress 2024, BridgeBio shared four positive analyses, which included the following data:
- In a pre-specified Cochran-Mantel-Haenszel sensitivity analysis applied to the entire ITT population of the study (N=632), acoramidis significantly reduced ACM (p=0.04), with no safety signals of potential clinical concern.
- Among ATTRibute-CM participants enrolled with Stage 4 chronic kidney disease (CKD) (N=21), acoramidis treatment was associated with proportionally fewer deaths compared with placebo, with no safety signals of potential clinical concern.
- At Month 30 of the ATTRibute-CM study, acoramidis treatment resulted in a statistically significant and clinically important reduction in the progressive decline in health-related quality of life as assessed by the EuroQoL Health Outcomes Assessment tool, EQ-5D-5L.
- Acoramidis treatment also reduced the decline in health status and quality of life as shown by statistically significant and clinically meaningful benefits in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score and supported by numerical and consistent benefits in individual KCCQ domains.
- In ATTRibute-CM, acoramidis significantly improved NT-proBNP indices that can be a signal of ATTR-CM disease progression and be predictive of subsequent mortality risk.
- During the 2024 American College of Cardiology (ACC), BridgeBio presented cardiac magnetic resonance (CMR) imaging evidence consistent with clinical improvement observed in the ATTRibute-CM. The data demonstrate that targeting near-complete TTR stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM.
- During the 2024 International Symposium of Amyloidosis (ISA), five new analyses were disclosed through oral presentations and posters, discussing the following:
- Encaleret – Calcium-sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1):
- CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, continues to enroll; the Company anticipates sharing topline data from CALIBRATE in 2025.
- BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):
- BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with LGMD2I/R9, with top-line results from the interim analysis expected in 2025.
- Recent Type C interactions with U.S. FDA focused on the validated glycosylated alpha-dystroglycan (αDG) bioassay and our interim analysis plans reinforce BridgeBio’s belief that there is potential to pursue Accelerated Approval for BBP-418.
- Rare Pediatric Disease Designation for BBP-418 highlights that LGMD2I/R9 is a rare disease with serious manifestations, which primarily impacts children. If BBP-418 is approved, BridgeBio may qualify for a Priority Review Voucher, which can be applied to another therapy in the Company’s pipeline for a shorter timeline during the review process of a NDA or can be sold to another company looking to receive priority review for one of its applications.
- Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:
- BridgeBio shared data from Month 12 and 18 for Cohort 5 of PROPEL 2 (0.25 mg/kg/day), its Phase 2 trial in achondroplasia with the oral treatment, infigratinib, with results including:
- A statistically significant and sustained increase in AHV, with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015).
- At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). The mean upper to lower body segment ratio was 1.88 at Month 18, as compared to 2.02 at baseline.
- Infigratinib continues to be well-tolerated as a single daily oral therapy with no adverse events (AEs) assessed as treatment-related in any participant in Cohort 5.
- Infigratinib for achondroplasia was granted Fast Track Designation and Rare Pediatric Drug Designation by the U.S. FDA. If infigratinib is approved, BridgeBio may qualify for a Priority Review Voucher.
- In May 2024, the first participant consented to be part of ACCEL, the observational run-in study for infigratinib in children living with hypochondroplasia.
- BridgeBio shared data from Month 12 and 18 for Cohort 5 of PROPEL 2 (0.25 mg/kg/day), its Phase 2 trial in achondroplasia with the oral treatment, infigratinib, with results including:
Second Quarter 2024 Financial Results:
Cash, Cash Equivalents, Marketable Securities and Short-term Restricted Cash
Cash, cash equivalents, marketable securities and short-term restricted cash, totaled
Revenue
Revenue for the three and six months ended June 30, 2024 were
The increase of
The increase of
Operating Costs and Expenses
Operating costs and expenses for the three and six months ended June 30, 2024 were
The overall increase of
The overall increase of
Restructuring, impairment and related charges for the three and six months ended June 30, 2024 amounted to
Stock-based compensation expenses included in operating costs and expenses for the three months ended June 30, 2024 were
Stock-based compensation expenses included in operating costs and expenses for the six months ended June 30, 2024 were
Total Other Income (Expense), net
Total other income (expense), net for the three and six months ended June 30, 2024 were
The increase in total other income (expense), net of
The increase in total other income (expense), net of
Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share
For the three months and six months ended June 30, 2024, the Company recorded a net loss attributable to common stockholders of BridgeBio of
For the three months and six months ended June 30, 2024, the Company reported a net loss per share of
| BRIDGEBIO PHARMA, INC. Condensed Consolidated Statements of Operations (in thousands, except shares and per share amounts) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue | $ | 2,168 | $ | 1,641 | $ | 213,288 | $ | 3,467 | ||||||||
| Operating costs and expenses: | ||||||||||||||||
| Research, development and other expenses | 115,293 | 108,087 | 256,863 | 201,599 | ||||||||||||
| Selling, general and administrative | 59,523 | 36,122 | 125,330 | 67,230 | ||||||||||||
| Restructuring, impairment and related charges | 2,891 | 3,531 | 6,291 | 6,900 | ||||||||||||
| Total operating costs and expenses | 177,707 | 147,740 | 388,484 | 275,729 | ||||||||||||
| Loss from operations | (175,539 | ) | (146,099 | ) | (175,196 | ) | (272,262 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 5,195 | 4,514 | 9,270 | 8,667 | ||||||||||||
| Interest expense | (22,937 | ) | (20,594 | ) | (46,408 | ) | (40,715 | ) | ||||||||
| Gain on deconsolidation of a subsidiary | 126,294 | — | 126,294 | — | ||||||||||||
| Loss on extinguishment of debt | — | — | (26,590 | ) | — | |||||||||||
| Net loss from equity method investment | (7,925 | ) | — | (7,925 | ) | — | ||||||||||
| Other income (expense), net | (632 | ) | 1,476 | 8,851 | 875 | |||||||||||
| Total other income (expense), net | 99,995 | (14,604 | ) | 63,492 | (31,173 | ) | ||||||||||
| Net loss | (75,544 | ) | (160,703 | ) | (111,704 | ) | (303,435 | ) | ||||||||
| Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests | 2,088 | 2,804 | 3,032 | 5,380 | ||||||||||||
| Net loss attributable to common stockholders of BridgeBio | $ | (73,456 | ) | $ | (157,899 | ) | $ | (108,672 | ) | $ | (298,055 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.39 | ) | $ | (0.98 | ) | $ | (0.59 | ) | $ | (1.90 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 187,586,680 | 160,535,435 | 183,145,995 | 156,645,838 | ||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| Stock-based Compensation | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Research, development and other expenses | $ | 4,937 | $ | 13,229 | $ | 17,716 | $ | 25,008 | ||||||||
| Selling, general and administrative | 16,471 | 13,947 | 32,542 | 25,645 | ||||||||||||
| Restructuring, impairment and related charges | 43 | — | 43 | — | ||||||||||||
| Total stock-based compensation | $ | 21,451 | $ | 27,176 | $ | 50,301 | $ | 50,653 | ||||||||
| BRIDGEBIO PHARMA, INC. Condensed Consolidated Balance Sheets (In thousands) | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Assets | (Unaudited) | (1) | ||||||
| Cash, cash equivalents and marketable securities | $ | 447,771 | $ | 375,935 | ||||
| Investments in equity securities | — | 58,949 | ||||||
| Receivables from licensing and collaboration agreements | 660 | 1,751 | ||||||
| Short-term restricted cash | 139,409 | 16,653 | ||||||
| Prepaid expenses and other current assets | 28,396 | 24,305 | ||||||
| Investment in nonconsolidated entity | 117,006 | - | ||||||
| Property and equipment, net | 9,840 | 11,816 | ||||||
| Operating lease right-of-use assets | 7,267 | 8,027 | ||||||
| Intangible assets, net | 25,123 | 26,319 | ||||||
| Other assets | 18,903 | 22,625 | ||||||
| Total assets | $ | 794,375 | $ | 546,380 | ||||
| Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit | ||||||||
| Accounts payable | $ | 18,126 | $ | 10,655 | ||||
| Accrued and other liabilities | 96,517 | 122,965 | ||||||
| Operating lease liabilities | 11,682 | 13,109 | ||||||
| Deferred revenue | 32,059 | 9,823 | ||||||
| 2029 Notes, net | 737,882 | 736,905 | ||||||
| 2027 Notes, net | 544,270 | 543,379 | ||||||
| Term loan, net | 435,447 | 446,445 | ||||||
| Other long-term liabilities | 485 | 5,634 | ||||||
| Redeemable convertible noncontrolling interests | (223 | ) | 478 | |||||
| Total BridgeBio stockholders' deficit | (1,092,925 | ) | (1,354,257 | ) | ||||
| Noncontrolling interests | 11,055 | 11,244 | ||||||
| Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit | $ | 794,375 | $ | 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 (Unaudited) (In thousands) | ||||||||
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating activities: | ||||||||
| Net loss | $ | (111,704 | ) | $ | (303,435 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 38,511 | 49,085 | ||||||
| Loss on extinguishment of debt | 26,590 | — | ||||||
| Accretion of debt | 3,683 | 4,580 | ||||||
| Depreciation and amortization | 3,170 | 3,270 | ||||||
| Noncash lease expense | 2,093 | 2,024 | ||||||
| Accrual of payment-in-kind interest on term loan | — | 6,742 | ||||||
| Net loss from equity method investment | 7,925 | — | ||||||
| Loss (gain) on deconsolidation of subsidiaries | (126,294 | ) | 1,241 | |||||
| Gain from investment in equity securities, net | (8,136 | ) | (2,399 | ) | ||||
| Fair value adjustment of warrants | — | (222 | ) | |||||
| Other noncash adjustments | (1,911 | ) | (328 | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Receivables from licensing and collaboration agreements | 1,091 | 8,466 | ||||||
| Prepaid expenses and other current assets | (6,506 | ) | 1,057 | |||||
| Other assets | 942 | 32 | ||||||
| Accounts payable | 8,858 | (4,098 | ) | |||||
| Accrued compensation and benefits | (8,378 | ) | (11,071 | ) | ||||
| Accrued research and development liabilities | 7,067 | (11,322 | ) | |||||
| Operating lease liabilities | (2,981 | ) | (2,443 | ) | ||||
| Deferred revenue | 22,236 | (3,184 | ) | |||||
| Accrued professional and other liabilities | (1,090 | ) | 4,330 | |||||
| Net cash used in operating activities | (144,834 | ) | (257,675 | ) | ||||
| Investing activities: | ||||||||
| Purchases of marketable securities | (93,811 | ) | (19,754 | ) | ||||
| Maturities of marketable securities | 55,000 | 41,550 | ||||||
| Purchases of investments in equity securities | (20,271 | ) | (71,504 | ) | ||||
| Proceeds from sales of investments in equity securities | 63,229 | 67,068 | ||||||
| Proceeds from special cash dividends received from investments in equity securities | 25,682 | — | ||||||
| Payment for an intangible asset | (3,190 | ) | — | |||||
| Purchases of property and equipment | (749 | ) | (440 | ) | ||||
| Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries | (98 | ) | (503 | ) | ||||
| Net cash provided by investing activities | 25,792 | 16,417 | ||||||
| Financing activities: | ||||||||
| Proceeds from term loan under Financing Agreement | 450,000 | — | ||||||
| Issuance costs and discounts associated with term loan under Financing Agreement | (15,986 | ) | — | |||||
| Repayment of term loan under Loan and Security Agreement | (473,417 | ) | — | |||||
| Proceeds from issuance of common stock through public offerings, net | 314,759 | 144,049 | ||||||
| Proceeds from BridgeBio common stock issuances under ESPP | 2,364 | 1,809 | ||||||
| Proceeds from stock option exercises, net of repurchases | 778 | 312 | ||||||
| Repurchase of RSU shares to satisfy tax withholding | (4,679 | ) | (1,715 | ) | ||||
| Other financing activities | — | 4,563 | ||||||
| Net cash provided by financing activities | 273,819 | 149,018 | ||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 154,777 | (92,240 | ) | |||||
| Cash, cash equivalents and restricted cash at beginning of period | 394,732 | 416,884 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 549,509 | $ | 324,644 | ||||
| Six Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Supplemental Disclosure of Cash Flow Information: | ||||||||
| Cash paid for interest | $ | 49,046 | $ | 28,738 | ||||
| Supplemental Disclosures of Noncash Investing and Financing Information: | ||||||||
| Unpaid public offering issuance costs | $ | 18 | $ | — | ||||
| Deferred and unpaid issuance costs recorded to "Accrued and other liabilities" | $ | 74 | $ | — | ||||
| Unpaid property and equipment | $ | 70 | $ | 131 | ||||
| Transfers to noncontrolling interests | $ | (1,929 | ) | $ | (5,940 | ) | ||
| Reconciliation of Cash, Cash Equivalents and Restricted Cash: | ||||||||
| Cash and cash equivalents | $ | 407,958 | $ | 302,438 | ||||
| Restricted cash | 139,409 | 19,930 | ||||||
| Restricted cash — Included in “Other assets” | 2,142 | 2,276 | ||||||
| Total cash, cash equivalents and restricted cash at end of period shown in the condensed consolidated statements of cash flows | $ | 549,509 | $ | 324,644 | ||||
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a commercial-stage 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 and Twitter.
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 statements relating to the clinical and therapeutic, market potential of the Company’s programs and product candidates, including the statements in Dr. Kumar’s quote regarding the potential commercial launch of acoramidis (if approved) and the Company’s goal of fully enrolling its three Phase 3 clinical programs, continued advancement in the Company’s pipeline, including enrollments in clinical trials and anticipated readouts, and other benefits resulting from recent financing activities; the statements related to the FDA’s planned actions regarding the Company’s NDA for acoramidis for the treatment of ATTR-CM; the potential outcomes of regulatory interactions with and reviews by the FDA and the European Medicines Agency; the timing and success of the Company’s clinical development programs, including the progress of the Company’s clinical development program for acoramidis for patients with ATTR-CM, and the Company’s plan for, and the expected timing of, initiation of ACT-EARLY, the Company’s planned acoramidis ATTR amyloidosis prevention trial; the potential payments we may receive under the recent license agreement with Bayer and Kyowa Kirin; the continuation of PROPEL 3, the Company’s Phase 3 study of infigratinib for achondroplasia and the expected timing for completion of the study; the Company’s commitment to exploring the potential of infigratinib and expectation regarding the Company’s clinical program for hypochondroplasia; the continuation and progress of FORTIFY, the Phase 3 trial of BBP-418 for LGMD2I/R9, including the expected receipt of top-line results from the interim analysis population, and the potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA; the Company’s ability to qualify for Priority Review Vouchers with respect to BBP-418 and infigratinib; the continued enrollment in CALIBRATE, the Phase 3 clinical trial of encaleret, and the timing for sharing topline data from CALIBRATE; and the Company’s financial performance, capitalization status, strategy, business plans and goals reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although the Company believes that its 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 the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s 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 the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s 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 rising interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and the Company’s 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 the Company’s 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 Contact:
Vikram Bali
contact@bridgebio.com
(650)-789-8220
FAQ
What were BridgeBio's Q2 2024 revenues?
How did Acoramidis perform in clinical trials?
What is the annualized height velocity (AHV) for infigratinib in the PROPEL 2 study?
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