BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a
new type of biopharmaceutical company focused on genetic diseases,
today reported its financial results for the third quarter ended
September 30, 2024, and provided an update on the Company’s
operations.
“I’m grateful for the continued progress that we
have seen across our late-stage pipeline, and I’m excited for the
upcoming opportunity to serve patients with ATTR-CM in the
commercial marketplace,” said Dr. Neil Kumar, Ph.D., CEO and
Founder of BridgeBio. “Underpinning this headway is a corporate
experiment we have been conducting for over 9 years now that posits
a new type of biotech business model, and so I’m also proud to have
released our first case study in The Journal of Portfolio
Management, highlighting salient elements of that model.”
Pipeline overview:
Program |
Status |
Next expected milestone |
Acoramidis for ATTR-CM |
NDA filed with U.S. FDA |
November 29, 2024 PDUFA date |
Encaleret for ADH1 |
Enrolling CALIBRATE, Phase 3 study |
Enrollment completion in 2024 |
BBP-418 (ribitol) for LGMD2I/R9 |
FORTIFY, Phase 3 study enrollment completed |
Interim analysis in 2025 |
Infigratinib for achondroplasia |
Enrolling PROPEL 3, Phase 3 study |
Enrollment completion in 2024 |
Infigratinib for hypochondroplasia |
Enrolling observational run-in for ACCEL 2, Phase 2 study |
Enrollment completion date to be announced |
BBP-812 for Canavan disease |
Enrolling at high dose in Phase 1/2 study |
Enrollment completion date to be announced |
Late-stage investigational programs
updates:
- Acoramidis – Near-complete transthyretin (TTR)
stabilizer for transthyretin amyloid cardiomyopathy
(ATTR-CM):
- Based on the positive results from ATTRibute-CM, BridgeBio
filed a new drug application (NDA) to the FDA, which has been
accepted with a PDUFA action date of November 29, 2024, and the
late cycle meeting with the FDA has been completed.
- Outcomes data through 42 months from the ongoing long-term
open-label extension (OLE) of ATTRibute-CM, the Company’s Phase 3
study of acoramidis in ATTR-CM, will be shared at the American
Heart Association (AHA) Scientific Sessions on November
18th.
- During the European Society of Cardiology (ESC) 2024, a new
analysis was shared in an oral presentation, showing:
- Increased serum TTR at Day 28 of ATTRibute-CM was correlated
with reduced risk of ACM, cardiovascular mortality (CVM) and CVH in
ATTR-CM.
- A mean of 3.0mg/dL increase in serum transthyretin (TTR) at
Month 1 of the OLE (n=21) and mean of 3.4mg/dL increase in serum
TTR at Month 6 of the OLE (n=18) in participants who switched from
tafamidis and placebo to acoramidis in the ATTRibute-CM study.
- A post-hoc analysis of ATTRibute-CM evaluating the effect of
acoramidis on the composite endpoint of ACM and recurrent CVH
events was shared at the Heart Failure Society of America (HFSA)
Annual Scientific Meeting 2024, which included the following
data:
- A 42% reduction in composite ACM and recurrent CVH events at 30
months observed with acoramidis treatment compared to placebo by
applying a negative binomial regression model (post-hoc)
(p=0.0005).
- A 42% reduction in the total number of ACM and recurrent CVH
events per patient observed over 30 months with acoramidis
treatment compared to placebo.
- A 30.5% hazard reduction in ACM and recurrent CVH events at 30
months observed with acoramidis treatment compared to placebo by
applying the Andersen-Gill model (post-hoc) (p=0.0008).
- BridgeBio announced the initiation of a scientific
collaboration with the CarDS Lab, led by
cardiologist-data scientist, Rohan Khera, M.D., M.S. at the Yale
School of Medicine, for the launch of the TRACE-AI Network, a novel
paradigm of large-scale federated AI screening for
ATTR-CM.
- Upon FDA approval of acoramidis, it is our intent to honor the
courage of our U.S. clinical trial patients by providing them
acoramidis free for life.
- Encaleret – Calcium-sensing receptor (CaSR) antagonist
for autosomal dominant hypocalcemia type 1 (ADH1):
- CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1,
completed screening; the Company anticipates completing enrollment
of the CALIBRATE study in 2024.
- Proof-of-principle data of encaleret, an oral option for
post-surgical hypoparathyroidism, were presented at the American
Society for Bone Mineral Research meeting demonstrating a
concomitant normalization of blood and urine calcium in 86% of
participants within 5 days.
- BBP-418 (ribitol) – Glycosylation substrate for
limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):
- BridgeBio completed enrollment of FORTIFY, the Company’s Phase
3 registrational study of BBP-418 in individuals with LGMD2I/R9,
with topline data readout from the interim analysis expected in
2025.
- BridgeBio believes there is an opportunity to pursue
Accelerated Approval in the U.S. for BBP-418 in LGMD2I/R9 based on
a potential biomarker surrogate endpoint of glycosylated
alpha-dystroglycan (αDG) at time of the interim
analysis.
- The FDA has granted Rare Pediatric Disease Designation for
BBP-418 in the treatment of LGMD2I/R9. 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 New Drug Application or can
be sold and transferred to another company looking to receive
priority review for one of its applications.
- Infigratinib – FGFR1-3 inhibitor for achondroplasia and
hypochondroplasia:
- The FDA granted Breakthrough Therapy Designation to
infigratinib for demonstrating substantial improvement in efficacy
over available therapies on clinically significant
endpoint(s).
- The PROPEL 3 global Phase 3 registrational study of
infigratinib in achondroplasia continues to enroll; study
completion anticipated by the end of the year. PROPEL, BridgeBio’s
observational lead-in study in achondroplasia for PROPEL 3, has
completed enrollment.
- The initial phase of MyAchonJourney, a new
online resource to support individuals and families living with
achondroplasia, was launched.
- ACCEL 2/3 will be a global Phase 2/3 multicenter, single-dose
study, to evaluate the efficacy and safety of 0.25mg/kg/day of
infigratinib in children living with hypochondroplasia. ACCEL,
BridgeBio’s observational lead-in study for hypochondroplasia,
continues to enroll.
- BBP-812 – Adeno-associated virus (AAV) 9 gene therapy
for Canavan disease:
- The Canavan disease program received RMAT Designation based on
preliminary clinical evidence from the CANaspire Phase 1/2 clinical
trial.
- BridgeBio will leverage the benefits of RMAT designation,
including early and more frequent interactions with the FDA, to
establish an Accelerated Approval pathway for BBP-812.
- New positive data from the high-dose cohort includes:
- Progressive and continued post-dose improvement in gross motor
function (measured by Gross Motor Function Measure (GMFM)-88) and
achievement of motor milestones (measured by Hammersmith Infant
Neurological Examination (HINE)-2).
- In the low-dose cohort, these strikingly divergent trajectories
resulted in statistically significant improvements in achieved
motor function and milestones at 12-months after treatment with
BBP-812, compared to what is observed in and predicted by the
natural history of the disease seen in BridgeBio’s study,
CANinform; data from the high dose cohort are not yet
available.
Third Quarter 2024 Financial
Results:
“We are prepared to launch acoramidis in the U.S.,
upon approval by the FDA, at the end of 2024 as well as to read out
our three ongoing Phase 3 studies in 2025,” said Brian Stephenson,
Ph.D., CFA, Chief Financial Officer of BridgeBio. “As we continue
to move our late-stage pipeline forward, we are excited to also
take an initial step in explaining the thesis and underlying logic
of our decision making with the recent release of our case study in
The Journal of Portfolio Management.”
Cash, Cash Equivalents, and Short-term
Restricted Cash
Cash, cash equivalents and short-term restricted
cash, totaled $405.7 million as of September 30, 2024,
compared to $392.6 million of cash, cash equivalents and short-term
restricted cash as of December 31, 2023. The $13.1 million net
increase in cash, cash equivalents and short-term restricted cash
was primarily attributable to net proceeds received from the term
loan under the credit facility with Blue Owl 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 refinancing the Company’s previous senior secured
credit term loan, inclusive of prepayment fees and exit-related
costs in aggregate of $473.4 million, net cash used in operating
activities of $325.4 million, purchases of equity securities of
$20.3 million, and repurchase of shares to satisfy tax withholdings
of $6.1 million during the nine months ended September 30,
2024.
Revenue
Revenue for the three and nine months ended
September 30, 2024 were $2.7 million and $216.0 million,
respectively, as compared to $4.1 million and $7.6 million for the
same periods in the prior year.
The decrease of $1.4 million in revenue for the
three months ended September 30, 2024, compared to the same
period in the prior year, was primarily due to the recognition of
services revenue under the exclusive license and collaboration
agreements with Bayer and Kyowa Kirin. Revenue for the three months
ended September 30, 2023 primarily consists of the recognition of
services revenue under the Navire-BMS License Agreement, which
terminated effective June 2024.
The increase of $208.4 million in revenue for the
nine months ended September 30, 2024, compared to the same
period in the prior year, was primarily due to $205.3 million from
recognition of non-refundable upfront payments and service revenue
under the Bayer and the Kyowa Kirin exclusive license and
collaboration agreements.
Operating Costs and Expenses
Operating costs and expenses for the three and
nine months ended September 30, 2024 were $194.5 million and
$583.0 million, respectively, compared to $161.8 million and $437.5
million for the same periods in the prior year.
The overall increase of $32.7 million in operating
costs and expenses for the three months ended September 30,
2024, compared to the same period in the prior year, was primarily
due to an increase of $33.0 million in selling, general and
administrative (SG&A) expenses mainly to support
commercialization readiness efforts which included costs incurred
for marketing, advertising and buildup of salesforce, an increase
of $4.3 million in restructuring, impairment and related charges,
offset by a decrease of $4.6 million in research and development
and other expenses (R&D) mainly due to the deconsolidation of
certain subsidiaries.
The overall increase of $145.5 million in
operating costs and expenses for the nine months ended
September 30, 2024, compared to the same period in the prior
year, was primarily due to an increase of $91.1 million in SG&A
expenses mainly to support commercialization readiness efforts
which included costs incurred for marketing, advertising and
buildup of salesforce, an increase of $50.6 million in R&D
expenses to advance the Company’s pipeline of research and
development programs, and an increase of $3.8 million in
restructuring, impairment and related charges. Operating costs and
expenses for the nine months ended September 30, 2024, include
$25.0 million of nonrecurring deal-related costs for transactions
that were completed during the nine months ended September 30,
2024.
Restructuring, impairment and related charges for
the three and nine months ended September 30, 2024 amounted to
$4.6 million and $10.9 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 $0.3 million and $7.2
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
September 30, 2024 were $27.1 million, of which $12.1 million
is included in R&D expenses, $15.0 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 $27.2 million, of which
$14.1 million is included in R&D expenses, and $13.1 million is
included in SG&A expenses.
Stock-based compensation expenses included in
operating costs and expenses for the nine months ended
September 30, 2024 were $77.4 million, of which $29.8 million
is included in R&D expenses, $47.5 million is included in
SG&A expenses, and $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 $77.9 million, of which $39.2 million is included
in R&D expenses, and $38.7 million is included in SG&A
expenses.
Total Other Income (Expense), net
Total other income (expense), net for the three and nine months
ended September 30, 2024 were $27.5 million and $91.0 million,
respectively, compared to ($21.8) million and ($53.0) million for
the same periods in the prior year.
The increase in total other income (expense), net
of $49.3 million for the three months ended September 30,
2024, compared to the same period in the prior year, was primarily
due to the Company’s gain on deconsolidation of subsidiaries of
$52.0 million and an increase in other income (expense), net of
$7.1 million mainly due to mark to market fair value adjustments
from the Company’s investments in equity securities. This was
partially offset by a net loss from an equity method investment of
$6.6 million and an increase in interest expense of $2.8
million.
The increase in total other income (expense), net
of $144.0 million for the nine months ended September 30,
2024, compared to the same period in the prior year, was primarily
due to the Company’s gain on deconsolidation of subsidiaries of
$178.3 million and an increase in other income (expense), net of
$15.1 million mainly due to mark to market fair value adjustments
from the Company’s investments in equity securities. These were
partially offset by recognition of a loss on extinguishment of debt
of $26.6 million, a net loss from equity method investments of
$14.5 million and an increase in interest expense of $8.4
million.
Net Loss Attributable to Common
Stockholders of BridgeBio and Net Loss per Share
For the three and nine months ended
September 30, 2024, the Company recorded a net loss
attributable to common stockholders of BridgeBio of $162.0 million
and $270.7 million, respectively, compared to $177.0 million and
$475.1 million, respectively for the three and nine months ended
September 30, 2023.
For the three and nine months ended
September 30, 2024, the Company reported a net loss per share
of $0.86 and $1.46, respectively compared to $1.08 and $2.99,
respectively for the three and nine months ended September 30,
2023.
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share
amounts)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue |
|
$ |
2,732 |
|
|
$ |
4,091 |
|
|
$ |
216,020 |
|
|
$ |
7,558 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research, development and other expenses |
|
|
121,042 |
|
|
|
125,734 |
|
|
|
377,905 |
|
|
|
327,333 |
|
Selling, general and administrative |
|
|
68,819 |
|
|
|
35,777 |
|
|
|
194,149 |
|
|
|
103,007 |
|
Restructuring, impairment and related charges |
|
|
4,621 |
|
|
|
272 |
|
|
|
10,912 |
|
|
|
7,172 |
|
Total operating costs and expenses |
|
|
194,482 |
|
|
|
161,783 |
|
|
|
582,966 |
|
|
|
437,512 |
|
Loss from operations |
|
|
(191,750 |
) |
|
|
(157,692 |
) |
|
|
(366,946 |
) |
|
|
(429,954 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,296 |
|
|
|
3,793 |
|
|
|
12,566 |
|
|
|
12,460 |
|
Interest expense |
|
|
(23,061 |
) |
|
|
(20,306 |
) |
|
|
(69,469 |
) |
|
|
(61,021 |
) |
Gain on deconsolidation of subsidiaries |
|
|
52,027 |
|
|
|
— |
|
|
|
178,321 |
|
|
|
— |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(26,590 |
) |
|
|
— |
|
Net loss from equity method investments |
|
|
(6,563 |
) |
|
|
— |
|
|
|
(14,488 |
) |
|
|
— |
|
Other income (expense), net |
|
|
1,797 |
|
|
|
(5,283 |
) |
|
|
10,648 |
|
|
|
(4,408 |
) |
Total other income (expense), net |
|
|
27,496 |
|
|
|
(21,796 |
) |
|
|
90,988 |
|
|
|
(52,969 |
) |
Net loss |
|
|
(164,254 |
) |
|
|
(179,488 |
) |
|
|
(275,958 |
) |
|
|
(482,923 |
) |
Net loss attributable to redeemable convertible noncontrolling
interests and noncontrolling interests |
|
|
2,214 |
|
|
|
2,489 |
|
|
|
5,246 |
|
|
|
7,869 |
|
Net loss attributable to common stockholders of BridgeBio |
|
$ |
(162,040 |
) |
|
$ |
(176,999 |
) |
|
$ |
(270,712 |
) |
|
$ |
(475,054 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(1.08 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.99 |
) |
Weighted-average shares used in computing net loss per share,
basic and diluted |
|
|
188,510,372 |
|
|
|
163,308,632 |
|
|
|
184,947,173 |
|
|
|
158,891,152 |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
Stock-based Compensation |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Research, development and other expenses |
|
$ |
12,124 |
|
|
$ |
14,144 |
|
|
$ |
29,840 |
|
|
$ |
39,152 |
|
Selling, general and administrative |
|
|
14,969 |
|
|
|
13,086 |
|
|
|
47,511 |
|
|
|
38,731 |
|
Restructuring, impairment and related charges |
|
|
38 |
|
|
|
— |
|
|
|
81 |
|
|
|
— |
|
Total stock-based compensation |
|
$ |
27,131 |
|
|
$ |
27,230 |
|
|
$ |
77,432 |
|
|
$ |
77,883 |
|
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets (In
thousands)
|
|
September 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
Assets |
|
(Unaudited) |
|
|
(1) |
|
Cash and cash equivalents |
|
$ |
266,324 |
|
|
$ |
375,935 |
|
|
Investments in equity securities |
|
|
— |
|
|
|
58,949 |
|
|
Receivables from licensing and collaboration agreements |
|
|
478 |
|
|
|
1,751 |
|
|
Short-term restricted cash |
|
|
139,409 |
|
|
|
16,653 |
|
|
Prepaid expenses and other current assets |
|
|
38,367 |
|
|
|
24,305 |
|
|
Investment in nonconsolidated entities |
|
|
160,443 |
|
|
|
— |
|
|
Property and equipment, net |
|
|
8,701 |
|
|
|
11,816 |
|
|
Operating lease right-of-use assets |
|
|
6,439 |
|
|
|
8,027 |
|
|
Intangible assets, net |
|
|
24,525 |
|
|
|
26,319 |
|
|
Other assets |
|
|
20,291 |
|
|
|
22,625 |
|
|
Total assets |
|
$ |
664,977 |
|
|
$ |
546,380 |
|
|
Liabilities, Redeemable Convertible Noncontrolling
Interests and Stockholders’ Deficit |
|
|
|
|
|
|
Accounts payable |
|
$ |
13,363 |
|
|
$ |
10,655 |
|
|
Accrued and other liabilities |
|
|
109,482 |
|
|
|
122,965 |
|
|
Operating lease liabilities |
|
|
10,433 |
|
|
|
13,109 |
|
|
Deferred revenue |
|
|
30,398 |
|
|
|
9,823 |
|
|
2029 Notes, net |
|
|
738,376 |
|
|
|
736,905 |
|
|
2027 Notes, net |
|
|
544,719 |
|
|
|
543,379 |
|
|
Term loan, net |
|
|
436,221 |
|
|
|
446,445 |
|
|
Other long-term liabilities |
|
|
377 |
|
|
|
5,634 |
|
|
Redeemable convertible noncontrolling interests |
|
|
645 |
|
|
|
478 |
|
|
Total BridgeBio stockholders' deficit |
|
|
(1,229,922 |
) |
|
|
(1,354,257 |
) |
Noncontrolling interests |
|
|
10,885 |
|
|
|
11,244 |
|
|
Total liabilities, redeemable convertible noncontrolling interests
and stockholders’ deficit |
|
$ |
664,977 |
|
|
$ |
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)
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
Operating activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(275,958 |
) |
|
$ |
(482,923 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
65,673 |
|
|
|
71,685 |
|
Loss on extinguishment of debt |
|
|
26,590 |
|
|
|
— |
|
Accretion of debt |
|
|
5,399 |
|
|
|
6,724 |
|
Depreciation and amortization |
|
|
4,708 |
|
|
|
4,909 |
|
Noncash lease expense |
|
|
3,119 |
|
|
|
3,024 |
|
Accrual of payment-in-kind interest on term loan |
|
|
— |
|
|
|
6,742 |
|
Net loss from equity method investments |
|
|
14,488 |
|
|
|
— |
|
Loss (gain) on deconsolidation of subsidiaries |
|
|
(178,321 |
) |
|
|
1,241 |
|
Loss (gain) from investment in equity securities, net |
|
|
(8,136 |
) |
|
|
2,951 |
|
Other noncash adjustments, net |
|
|
(2,059 |
) |
|
|
(332 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Receivables from licensing and collaboration agreements |
|
|
1,273 |
|
|
|
11,909 |
|
Prepaid expenses and other current assets |
|
|
(17,543 |
) |
|
|
(980 |
) |
Other assets |
|
|
(428 |
) |
|
|
1,443 |
|
Accounts payable |
|
|
5,257 |
|
|
|
(3,404 |
) |
Accrued compensation and benefits |
|
|
5,580 |
|
|
|
(4,156 |
) |
Accrued research and development liabilities |
|
|
15,454 |
|
|
|
(10,544 |
) |
Operating lease liabilities |
|
|
(4,459 |
) |
|
|
(3,671 |
) |
Deferred revenue |
|
|
20,575 |
|
|
|
(4,464 |
) |
Accrued professional and other liabilities |
|
|
(6,612 |
) |
|
|
(3,055 |
) |
Net cash used in operating activities |
|
|
(325,400 |
) |
|
|
(402,901 |
) |
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 |
) |
|
|
(78,314 |
) |
Proceeds from sales of investments in equity securities |
|
|
63,229 |
|
|
|
80,963 |
|
Proceeds from special cash dividends received from investments in
equity securities |
|
|
25,682 |
|
|
|
— |
|
Payment for an intangible asset |
|
|
(4,785 |
) |
|
|
— |
|
Purchases of property and equipment |
|
|
(886 |
) |
|
|
(871 |
) |
Decrease in cash and cash equivalents resulting from
deconsolidation of subsidiaries |
|
|
(140 |
) |
|
|
(503 |
) |
Net cash provided by investing activities |
|
|
64,018 |
|
|
|
54,099 |
|
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 |
|
|
314,741 |
|
|
|
450,264 |
|
Proceeds from BridgeBio common stock issuances under ESPP |
|
|
4,502 |
|
|
|
3,397 |
|
Proceeds from stock option exercises, net of repurchases |
|
|
808 |
|
|
|
5,222 |
|
Transactions with noncontrolling interests |
|
|
— |
|
|
|
1,500 |
|
Repurchase of RSU shares to satisfy tax withholding |
|
|
(6,122 |
) |
|
|
(4,325 |
) |
Net cash provided by financing activities |
|
|
274,526 |
|
|
|
456,058 |
|
Net increase in cash, cash equivalents and restricted cash |
|
|
13,144 |
|
|
|
107,256 |
|
Cash, cash equivalents and restricted cash at beginning of
period |
|
|
394,732 |
|
|
|
416,884 |
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
407,876 |
|
|
$ |
524,140 |
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
Supplemental Disclosure of Cash Flow
Information: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
78,236 |
|
|
$ |
50,826 |
|
Supplemental Disclosures of Noncash Investing and Financing
Information: |
|
|
|
|
|
|
Unpaid public offering issuance costs |
|
$ |
— |
|
|
$ |
455 |
|
Unpaid property and equipment |
|
$ |
274 |
|
|
$ |
192 |
|
Transfers to noncontrolling interests |
|
$ |
(4,719 |
) |
|
$ |
(8,313 |
) |
Reconciliation of Cash, Cash Equivalents and Restricted
Cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
266,324 |
|
|
$ |
505,213 |
|
Restricted cash |
|
|
139,409 |
|
|
|
16,652 |
|
Restricted cash — Included in “Other assets” |
|
|
2,143 |
|
|
|
2,275 |
|
Total cash, cash equivalents and restricted cash at end of period
shown in the condensed consolidated statements of cash flows |
|
$ |
407,876 |
|
|
$ |
524,140 |
|
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. BridgeBio intends 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 the Company’s
clinical trials, including the PDUFA approval date for acoramidis
for the treatment of ATTR-CM; timing to share data from the
long-term open-label extension of ATTRibute-CM; the potential to
receive payments of $500 million and $105 million upon approval of
acoramidis; providing U.S. clinical trial patients acoramidis free
for life, upon approval; timing for completion of enrollment in
PROPEL 3 and completion of the study; timing for sharing top-line
results from FORTIFY for the interim analysis population; the
potential to pursue Accelerated Approval in the U.S. for
ribitol in LGMD2I/R9; the Company’s ability to qualify for a
Priority Review Voucher with respect to ribitol; timing for
completion of enrollment in CALIBRATE; and the expectation of early
and more frequent interactions with the FDA relating to BBP-812 for
the treatment of Canavan disease, among others, 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 the Company has made.
Although the Company believes that its plans, intentions,
expectations and strategies as reflected in or suggested by those
forward-looking statements are reasonable, the Company 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 changing 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 Quarterly Report on Form 10-Q
and Annual Report on Form 10-K and the Company’s other filings with
the U.S. Securities and Exchange Commission. Moreover, the Company
operates 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,
BridgeBio assumes 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
BridgeBio Pharma (NASDAQ:BBIO)
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