BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a
commercial-stage biopharmaceutical company focused on genetic
diseases and cancers, today reported its financial results for the
fourth quarter and full year ended December 31, 2023, and provided
an update on the Company’s operations.
“Our focus this year is executing on the launch of acoramidis
for patients with ATTR cardiomyopathy,” said Neil Kumar, Ph.D.,
founder and CEO of BridgeBio. “At the same time, we are also
focused on fully enrolling three ongoing Phase 3 clinical trials by
the end of 2024. Finally, we hope that reading out potentially
exciting data from our Phase 1/2 trial in congenital adrenal
hyperplasia later this year will let us take the next step in
serving that patient community.”
BridgeBio’s key programs:
- Acoramidis (AG10) – Transthyretin (TTR) stabilizer for
transthyretin amyloid cardiomyopathy (ATTR-CM):
- The Company filed an NDA for acoramidis for the treatment of
ATTR-CM with the US FDA; the NDA was accepted for review with a
PDUFA date of November 29, 2024. The Company has also filed a
Marketing Authorization Application for acoramidis with the EMA,
which has been accepted for review.
- The regulatory filings were based on data from the Phase 3
ATTRibute-CM study, which met its primary endpoint (Win Ratio of
1.8) with a highly statistically significant p-value (p<0.0001).
Additional results from ATTRibute-CM include:
- An 81% survival rate on acoramidis, which approaches the
survival rate in the age-matched U.S. database (~85%), and a 0.29
mean annual CVH rate on acoramidis, which approaches the annual
hospitalization rate observed in the broader U.S. Medicare
population (~0.26);
- Improvements from baseline observed for a large proportion of
participants treated with acoramidis on laboratory and functional
measures including n-terminal prohormone of brain natriuiretic
peptide (NT-proBNP) and 6-minute walk distance;
- Rapid clinical benefit on the composite endpoint of ACM and CVH
in participants treated with acoramidis, demonstrated by placebo
and acoramidis time-to-first event Kaplan-Meier curves for a
composite of ACM and CVH that separated at Month 3 and continued to
diverge steadily through Month 30 as presented at the American
Heart Association Scientific Sessions in November 2023; and
- Acoramidis was well-tolerated with no safety signals of
potential clinical concern identified.
- The Company also shared positive results of an open-label,
single-arm Phase 3 study conducted in Japan by licensing partner
Alexion, AstraZeneca Rare Disease, including that no mortality was
reported over the 30 month acoramidis treatment period.
- Additional detailed results of ATTRibute-CM are planned for
presentation at 2024 medical meetings.
- Low-dose infigratinib – FGFR1-3 inhibitor for
achondroplasia and hypochondroplasia:
- In December 2023, the Company announced the dosing of the first
child in PROPEL 3, its global Phase 3 registrational study of
infigratinib in achondroplasia.
- In February 2024, the Company announced a partnership with
Kyowa Kirin wherein the Company grants Kyowa Kirin an exclusive
license to develop and commercialize infigratinib for
achondroplasia, hypochondroplasia, and other skeletal dysplasias in
Japan; in exchange, the Company will receive an upfront payment of
$100 million as well as royalties up to the high-twenties percent
on sales of infigratinib in Japan, with the potential for
additional milestone-based payments.
- The Company is committed to exploring the potential of
infigratinib on the wider medical and functional impacts of
achondroplasia, hypochondroplasia and other skeletal dysplasias,
and anticipates initiating its clinical program for
hypochondroplasia in 2024.
- BBP-418 – Glycosylation substrate for limb-girdle
muscular dystrophy type 2I/R9 (LGMD2I/R9):
- FORTIFY, the global Phase 3 registrational trial of BBP-418,
continues to enroll in the U.S. with clinical trial sites
planned for Europe and Australia. Full enrollment of the
interim analysis population is expected in 2024. The Company
believes there is potential to pursue Accelerated Approval for
BBP-418 based on recent interactions with the FDA on the use of
glycosylated αDG levels as a surrogate endpoint.
- Encaleret – Calcium-sensing receptor (CaSR) inhibitor
for autosomal dominant hypocalcemia type 1 (ADH1):
- CALIBRATE, the Phase 3 clinical trial of encaleret, continues
to enroll; the Company anticipates sharing topline data from
CALIBRATE in 2025.
Recent Corporate Updates:
·Secured up to $1.25 billion of capital from Blue Owl
and CPP Investments: The raise includes $500 million in
cash from Blue Owl and CPP Investments available upon FDA approval
of acoramidis in exchange for a 5% royalty on future global net
sales of acoramidis, as well as a $450 million credit facility from
Blue Owl that refinanced existing senior secured credit, extending
maturity from 2026 to 2029 subject to certain conditions.
Fourth Quarter and Full Year 2023 Financial
Results:
Cash, Cash Equivalents, Marketable Securities and
Short-term Restricted Cash
Cash, cash equivalents and short-term restricted cash, totaled
$392.6 million as of December 31, 2023, compared to cash, cash
equivalents, marketable securities and short-term restricted cash
of $466.2 million as of December 31, 2022. The net decrease of
$73.6 million in cash, cash equivalents, marketable securities and
short-term restricted cash was primarily attributable to net cash
used in operating activities of $527.7 million and $6.9 million in
repurchase of shares to satisfy tax withholdings, primarily offset
by net proceeds received of $449.8 million from various equity
financings, $6.0 million from stock option exercises, and $3.4
million from common stock issuances under our employee stock
purchase plan during the year ended December 31, 2023.
Revenue
Revenue for the three months and year ended December 31,
2023 were $1.7 million and $9.3 million, respectively, as compared
to $1.9 million and $77.6 million for the same periods in the prior
year, respectively. The net decreases of $0.2 million and $68.3
million for the three months and year ended December 31, 2023,
respectively, compared to the same periods in the prior year, were
primarily due to license revenue recognized in 2022 upon the
transfer of the license in accordance with the Navire-BMS License
Agreement which was entered into in May 2022.
Operating Costs and Expenses
Operating costs and expenses for the three months and year ended
December 31, 2023 were $179.2 million and $616.7 million,
respectively, compared to $131.1 million and $589.9 million, for
the same periods in the prior year, respectively.
The overall increase of $48.1 million in operating costs and
expenses for the three months ended December 31, 2023,
compared to the same period in the prior year, was primarily due to
an increase of $39.3 million in research and development and other
expenses (R&D) to advance the Company's pipeline of development
programs, an increase of $15.7 million in selling, general and
administrative (SG&A) expenses to support commercialization
readiness efforts, offset by a decrease of $6.9 million in
restructuring, impairment and related charges given that the
majority of the restructuring initiatives occurred in the prior
year.
The overall increase of $26.8 million in operating costs and
expenses for the year ended December 31, 2023 , compared to
the same period in the prior year, was primarily due to an increase
of $55.2 million in R&D expenses to advance the Company's
pipeline of development programs, an increase of $7.4 million in
SG&A expenses to support commercialization readiness efforts,
offset by a decrease of $35.8 million in restructuring, impairment
and related charges given that the majority of the restructuring
initiatives occurred in the prior year.
Restructuring, impairment and related charges for the three
months and year ended December 31, 2023, amounted to $0.8
million and $7.9 million, respectively. These charges primarily
consisted of winding down, exit costs, and severance and
employee-related costs. Restructuring, impairment and related
charges for the same periods in the prior year were $7.7 million
and $43.8 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.
Stock-based compensation expenses included in operating costs
and expenses for the three months ended December 31, 2023 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 same period in the prior year were $22.6 million,
of which $8.9 million is included in R&D expenses, and $13.6
million is included in SG&A expenses.
Stock-based compensation expenses included in operating costs
and expenses for the year ended December 31, 2023 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. Stock-based
compensation expenses included in operating costs and expenses for
the same period in the prior year were $93.8 million, of which
$38.0 million is included in R&D expenses, $54.7 million is
included in SG&A expenses, and $1.2 million is included in
restructuring, impairment and related charges.
“Coming off of our recent royalty financing, we find ourselves
well capitalized to launch acoramidis this year alongside strong
new partners who share our confidence in acoramidis’ potential in
the ATTR-CM market,” said Brian Stephenson, Ph.D., CFA, Chief
Financial Officer of BridgeBio. “We are excited for this launch, as
well as for the continued advancement of our late stage pipeline,
which we hope will allow us to serve patients with genetic diseases
both directly with the advancement of those medicines towards the
market as well as by diversifying our top line revenue and enabling
reinvestment into the R&D and business development
opportunities that will allow us to be sustainable in the long
term.”
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, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(1) |
|
Revenue |
|
$ |
1,745 |
|
|
$ |
1,870 |
|
|
$ |
9,303 |
|
|
$ |
77,648 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research, development and other expenses |
|
|
130,824 |
|
|
|
91,549 |
|
|
|
458,157 |
|
|
|
402,896 |
|
Selling, general and administrative |
|
|
47,583 |
|
|
|
31,862 |
|
|
|
150,590 |
|
|
|
143,189 |
|
Restructuring, impairment and related charges |
|
|
754 |
|
|
|
7,691 |
|
|
|
7,926 |
|
|
|
43,765 |
|
Total operating costs and expenses |
|
|
179,161 |
|
|
|
131,102 |
|
|
|
616,673 |
|
|
|
589,850 |
|
Loss
from operations |
|
|
(177,416 |
) |
|
|
(129,232 |
) |
|
|
(607,370 |
) |
|
|
(512,202 |
) |
Other
income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
5,578 |
|
|
|
4,092 |
|
|
|
18,038 |
|
|
|
7,542 |
|
Interest expense |
|
|
(20,268 |
) |
|
|
(19,990 |
) |
|
|
(81,289 |
) |
|
|
(80,438 |
) |
Gain from sale of priority review voucher, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
107,946 |
|
Other income (expense), net |
|
|
21,778 |
|
|
|
4,560 |
|
|
|
17,370 |
|
|
|
(7,500 |
) |
Total other income (expense), net |
|
|
7,088 |
|
|
|
(11,338 |
) |
|
|
(45,881 |
) |
|
|
27,550 |
|
Net
loss |
|
|
(170,328 |
) |
|
|
(140,570 |
) |
|
|
(653,251 |
) |
|
|
(484,652 |
) |
Net loss
attributable to redeemable convertible noncontrolling
interests and noncontrolling interests |
|
|
2,180 |
|
|
|
2,979 |
|
|
|
10,049 |
|
|
|
3,469 |
|
Net loss
attributable to common stockholders of BridgeBio |
|
$ |
(168,148 |
) |
|
$ |
(137,591 |
) |
|
$ |
(643,202 |
) |
|
$ |
(481,183 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.96 |
) |
|
$ |
(0.92 |
) |
|
$ |
(3.95 |
) |
|
$ |
(3.26 |
) |
Weighted-average shares used in computing net loss per
share, basic and diluted |
|
|
174,462,332 |
|
|
|
149,344,380 |
|
|
|
162,791,511 |
|
|
|
147,473,076 |
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
Stock-based
Compensation |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(1) |
|
Research, development and others |
|
$ |
22,495 |
|
|
$ |
8,941 |
|
|
$ |
61,647 |
|
|
$ |
37,987 |
|
Selling, general and
administrative |
|
|
14,638 |
|
|
|
13,643 |
|
|
|
53,369 |
|
|
|
54,669 |
|
Restructuring, impairment and
related charges |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,172 |
|
Total stock-based compensation |
|
$ |
37,133 |
|
|
$ |
22,584 |
|
|
$ |
115,016 |
|
|
$ |
93,828 |
|
(1) |
The condensed consolidated financial statements as of and for the
year ended December 31, 2022 are derived from the audited
consolidated financial statements as of that date. |
BRIDGEBIO PHARMA, INC.Condensed
Consolidated Balance Sheets(In
thousands) |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
375,935 |
|
|
$ |
428,269 |
|
Investment in equity
securities |
|
|
58,949 |
|
|
|
43,653 |
|
Receivable from licensing and
collaboration agreements |
|
|
1,751 |
|
|
|
17,079 |
|
Short-term restricted
cash |
|
|
16,653 |
|
|
|
37,930 |
|
Prepaid expenses and other
current assets |
|
|
24,305 |
|
|
|
21,922 |
|
Property and equipment,
net |
|
|
11,816 |
|
|
|
14,569 |
|
Operating lease right-of-use
assets |
|
|
8,027 |
|
|
|
10,678 |
|
Intangible assets, net |
|
|
26,319 |
|
|
|
28,712 |
|
Other assets |
|
|
22,625 |
|
|
|
20,224 |
|
Total assets |
|
$ |
546,380 |
|
|
$ |
623,036 |
|
Liabilities,
Redeemable Convertible Noncontrolling Interests and Stockholders’
Deficit |
|
|
|
|
|
|
Accounts payable |
|
$ |
10,655 |
|
|
$ |
11,558 |
|
Accrued and other
liabilities |
|
|
129,061 |
|
|
|
106,195 |
|
Operating lease
liabilities |
|
|
13,109 |
|
|
|
15,949 |
|
2029 Notes, net |
|
|
736,905 |
|
|
|
734,988 |
|
2027 Notes, net |
|
|
543,379 |
|
|
|
541,634 |
|
Term loan, net |
|
|
446,445 |
|
|
|
430,993 |
|
Other long-term
liabilities |
|
|
9,361 |
|
|
|
26,643 |
|
Redeemable convertible
noncontrolling interests |
|
|
478 |
|
|
|
(1,589 |
) |
Total BridgeBio stockholders'
deficit |
|
|
(1,354,257 |
) |
|
|
(1,254,617 |
) |
Noncontrolling interests |
|
|
11,244 |
|
|
|
11,282 |
|
Total liabilities, redeemable
convertible noncontrolling interests and stockholders’ deficit |
|
$ |
546,380 |
|
|
$ |
623,036 |
|
(1) |
The condensed consolidated financial statements as of and for the
year ended December 31, 2022 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, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(1 ) |
|
Operating
activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(653,251 |
) |
|
$ |
(484,652 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
108,710 |
|
|
|
91,559 |
|
Depreciation and amortization |
|
|
6,494 |
|
|
|
6,771 |
|
Noncash lease expense |
|
|
4,032 |
|
|
|
5,172 |
|
Accrual of payment-in-kind interest on term loan |
|
|
10,207 |
|
|
|
13,562 |
|
Loss on deconsolidation of PellePharm |
|
|
1,241 |
|
|
|
— |
|
(Gain) loss from investment in equity securities, net |
|
|
(18,314 |
) |
|
|
8,222 |
|
Fair value of shares issued under a license agreement |
|
|
— |
|
|
|
4,567 |
|
Accretion of debt |
|
|
8,907 |
|
|
|
8,570 |
|
Fair value adjustment of warrants |
|
|
(984 |
) |
|
|
1,571 |
|
Loss on sale of certain assets |
|
|
— |
|
|
|
6,261 |
|
Impairment of long-lived assets |
|
|
— |
|
|
|
12,720 |
|
Gain from sale of priority review voucher, excluding transaction
costs |
|
|
— |
|
|
|
(110,000 |
) |
Gain from recognition of receivable from licensing and
collaboration agreement |
|
|
— |
|
|
|
(12,500 |
) |
Other noncash adjustments |
|
|
181 |
|
|
|
604 |
|
Changes in operating assets
and liabilities: |
|
|
|
|
|
|
Receivable from licensing and collaboration agreements |
|
|
15,328 |
|
|
|
15,169 |
|
Prepaid expenses and other current assets |
|
|
(2,702 |
) |
|
|
7,671 |
|
Other assets |
|
|
(1,546 |
) |
|
|
10,971 |
|
Accounts payable |
|
|
2,780 |
|
|
|
(349 |
) |
Accrued compensation and benefits |
|
|
7,802 |
|
|
|
(2,362 |
) |
Accrued research and development liabilities |
|
|
(9,855 |
) |
|
|
(4,309 |
) |
Operating lease liabilities |
|
|
(4,829 |
) |
|
|
(6,245 |
) |
Deferred revenue |
|
|
(5,438 |
) |
|
|
15,262 |
|
Accrued professional and other liabilities |
|
|
3,517 |
|
|
|
(7,729 |
) |
Net cash used in operating
activities |
|
|
(527,720 |
) |
|
|
(419,494 |
) |
Investing
activities: |
|
|
|
|
|
|
Purchases of marketable
securities |
|
|
(29,726 |
) |
|
|
(137,493 |
) |
Maturities of marketable
securities |
|
|
82,550 |
|
|
|
479,688 |
|
Purchases of investment in
equity securities |
|
|
(107,538 |
) |
|
|
(55,562 |
) |
Sales of investment in equity
securities |
|
|
110,556 |
|
|
|
52,835 |
|
Decrease in cash and cash
equivalents resulting from deconsolidation of PellePharm |
|
|
(503 |
) |
|
|
— |
|
Payment for intangible
asset |
|
|
— |
|
|
|
(1,500 |
) |
Proceeds from sale of priority
review voucher |
|
|
— |
|
|
|
110,000 |
|
Proceeds from sale of certain
assets |
|
|
— |
|
|
|
10,000 |
|
Purchases of property and
equipment |
|
|
(1,306 |
) |
|
|
(4,821 |
) |
Net cash provided by investing
activities |
|
|
54,033 |
|
|
|
453,147 |
|
Financing
activities: |
|
|
|
|
|
|
Proceeds from issuance of
common stock through Private Placement offering, net |
|
|
240,796 |
|
|
|
— |
|
Proceeds from issuance of
common stock through Follow-on offering, net |
|
|
144,049 |
|
|
|
— |
|
Proceeds from issuance of
common stock through ATM offering, net |
|
|
64,965 |
|
|
|
4,852 |
|
Transactions with
noncontrolling interests |
|
|
(801 |
) |
|
|
— |
|
Repayment of term loan |
|
|
— |
|
|
|
(20,486 |
) |
Proceeds from BridgeBio common
stock issuances under ESPP |
|
|
3,398 |
|
|
|
2,558 |
|
Repurchase of RSU shares to
satisfy tax withholding |
|
|
(6,880 |
) |
|
|
(1,561 |
) |
Proceeds from stock option
exercises, net of repurchases |
|
|
6,008 |
|
|
|
666 |
|
Other financing
activities |
|
|
— |
|
|
|
837 |
|
Net cash provided by (used in)
financing activities |
|
|
451,535 |
|
|
|
(13,134 |
) |
Net increase (decrease) in
cash, cash equivalents and restricted cash |
|
|
(22,152 |
) |
|
|
20,519 |
|
Cash, cash equivalents and
restricted cash at beginning of period |
|
|
416,884 |
|
|
|
396,365 |
|
Cash, cash equivalents and
restricted cash at end of period |
|
$ |
394,732 |
|
|
$ |
416,884 |
|
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(1) |
|
Supplemental
Disclosure of Cash Flow Information: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
61,108 |
|
|
$ |
54,443 |
|
Supplemental
Disclosures of Noncash Investing and Financing
Information: |
|
|
|
|
|
|
Unpaid property and
equipment |
|
$ |
100 |
|
|
$ |
47 |
|
Recognized intangible asset
recorded in “Other accrued and other long-term liabilities” |
|
$ |
— |
|
|
$ |
11,000 |
|
Transfers (to) from
noncontrolling interests |
|
$ |
(10,534 |
) |
|
$ |
(3,512 |
) |
Payment-in-kind interest added
to principal of term loan |
|
$ |
— |
|
|
$ |
1,763 |
|
Reconciliation of
Cash, Cash Equivalents and Restricted Cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
375,935 |
|
|
$ |
376,689 |
|
Short-term restricted
cash |
|
|
16,653 |
|
|
|
37,930 |
|
Restricted cash — Included in
“Other assets” |
|
|
2,144 |
|
|
|
2,265 |
|
Total cash, cash equivalents and restricted cash at end of
periods |
|
$ |
394,732 |
|
|
$ |
416,884 |
|
(1) |
The condensed consolidated financial statements as of and for the
year ended December 31, 2022 are derived from the audited
consolidated financial statements as of that date. |
|
|
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 and
cancers with clear genetic drivers. 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 our programs and
product candidates, including the statements in Dr. Kumar’s and Dr.
Stephenson's quotes regarding the potential commercial launch of
acoramidis (if approved), continued advancement in our pipeline,
including enrollments in clinical trials and anticipated readout,
and other benefits resulting from recent financing; the statements
related to the FDA's planned actions regarding our NDA for
acoramidis for the treatment of ATTR-CM; the potential outcomes of
regulatory reviews by the FDA and the EMA; the timing and success
of our clinical development programs, including the progress of our
clinical development program for acoramidis for patients with
ATTR-CM, and our plan for, and the expected timing of, presenting
additional detailed results of ATTRibute-CM study at medical
meetings; the potential success of our partnership granting Kyowa
Kirin an exclusive license on infigratinib for skeletal dysplasias
in Japan and the potential payments we may receive under the
license; the continuation of PROPEL 3, our Phase 3 study of
infigratinib for achondroplasia and the expected timing for full
enrollment in the study; our commitment to exploring the potential
of infigratinib and the expectation and timing of the initiation of
our clinical program for hypochondroplasia; the continuation and
progress of FORTIFY, the Phase 3 trial of BBP-418 for LGMD2I,
including the ongoing enrollment in the United States, the
expectation to enroll in clinical trial sites planned in Europe and
Australia, the expectation and timing of full enrollment of the
interim analysis population, and the potential to pursue
Accelerated Approval for BBP-418 based on recent interactions with
the FDA; the continued enrollment in CALIBRATE, the Phase 3
clinical trial of encaleret, and the expectation and timing of full
enrollment and sharing topline data from CALIBRATE; the Company’s
financial performance, capitalization status, strategy, business
plans and goals 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, the
Company’s ability to obtain additional funding, including through
less dilutive sources of capital than equity financings, potential
volatility in our share price, uncertainty regarding any impacts
due to global health emergencies such as COVID-19, including delays
in regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global
economy, 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 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 Contact: Vikram Bali
contact@bridgebio.com (650)-789-8220
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