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 third quarter ended September 30, 2023, and provided an
update on the Company’s operations.
“We continue to be extremely grateful to the patient and
physician communities with whom we collaborate; their partnership
has helped us to realize tremendous advancement recently across the
programs that make up our portfolio,” said Neil Kumar, Ph.D.,
founder and CEO of BridgeBio. “We are excited about the progress
from our late-stage pipeline, and have begun to highlight areas of
differentiation for the upcoming, potentially blockbuster launch of
our ATTR-CM asset. In particular, recent real-world evidence on
ATTR-CM therapies presented at the HFSA scientific sessions
suggests that the survival levels observed on acoramidis treatment
in our Phase 3 study are indeed differentiated even in the context
of the contemporary care setting as compared to other agents in the
field. This continues to reinforce our hypothesis that better
stabilization leads to better outcomes for patients with
ATTR-CM.”
BridgeBio’s key programs:
- Acoramidis (AG10) –
Transthyretin (TTR) stabilizer for transthyretin amyloid
cardiomyopathy (ATTR-CM):
- In August 2023, the Company presented
detailed positive results from its Phase 3 ATTRibute-CM study of
acoramidis for patients with ATTR-CM; a highly statistically
significant result was observed on the primary endpoint with a Win
Ratio of 1.8 (p<0.0001). This primary endpoint result
consistently favored acoramidis treatment across key subgroups,
including National Amyloidosis Center (NAC) ATTR stage I, II, and
III patients.
- Absolute values observed across
all-cause mortality (ACM), cardiovascular mortality (CVM) and CVH
showed that over 30 months, patients survived more and were
hospitalized less than has been seen in prior interventional
studies of ATTR-CM to the Company’s knowledge, including real-world
evidence presented at recent cardiology medical meetings.
- The 81% survival rate on acoramidis
approaches the survival rate in the age-matched U.S. database
(~85%); the 0.29 mean annual CVH rate on acoramidis approaches the
annual hospitalization rate observed in the broader U.S. Medicare
population (~0.26).
- Assessment of measures of disease
progression in the trial suggest that on acoramidis, 45% of
subjects experienced an improvement from baseline in N-terminal
prohormone of brain natriuretic peptide (NT-proBNP) versus 9% on
placebo, and 40% of subjects experienced an improvement from
baseline on 6-minute walk distance (6MWD) versus 24% on placebo. To
the Company’s knowledge, the proportions of treated patients
improving on these measures over 30 months are higher than have
been observed in prior controlled studies in ATTR-CM.
- We believe these points of
differentiation observed in the ATTRibute-CM results are made
possible by acoramidis achieving near-complete stabilization of
transthyretin (TTR) in both wild-type and variant ATTR patients;
serum TTR was promptly and consistently elevated throughout the
study.
- In an exploratory post-hoc analysis of
the relationship between on-treatment serum TTR levels and
on-treatment measures of CVH, NT-proBNP, and Kansas City
Cardiomyopathy Questionnaire (KCCQ), there was an association
between the mean on-treatment TTR level and each of these three
variables, consistent with the premise that higher degrees of
stabilization lead to better outcomes for patients.
- Acoramidis was well-tolerated with no
safety signals of potential clinical concern identified.
- The Company intends to file an NDA for
acoramidis with the FDA by the end of 2023 and marketing
authorization applications with additional regulatory authorities
globally in 2024.
- Additional detailed results of
ATTRibute-CM are planned for presentation at the American Heart
Association Scientific Sessions and the American College of
Cardiology Scientific Sessions.
- Low-dose infigratinib – FGFR1-3
inhibitor for achondroplasia and hypochondroplasia:
- In September 2023, the Company
completed positive regulatory meetings with the FDA and the EMA.
Alignment from the FDA and EMA was reached on the adequacy of a
one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial
for infigratinib to support a marketing application for the
treatment of children with achondroplasia.
- Based on the positive results to date,
the Company has been enrolling children in the run-in for PROPEL3,
the Phase 3 registrational study, and expects to initiate PROPEL3
by the end of 2023.
- If approved, the Company believes that
infigratinib has the potential to capture a significant share of
the market based on blinded market research.
- The Company is committed to exploring
the potential of infigratinib on the wider medical and functional
impacts of achondroplasia, hypochondroplasia and other skeletal
dysplasias, which hold significant unmet needs for families.
- BBP-418 – Glycosylation
substrate for limb-girdle muscular dystrophy type 2I/R9
(LGMD2I/R9):
- In October 2023, the Company shared new
long-term data from its Phase 2 trial in patients with LGMD2I/R9 at
the Annual Congress of World Muscle Society. The new long-term data
remains consistent with earlier data from the Phase 2 study showing
a well-tolerated safety profile and encouraging preliminary
efficacy. Additionally, early changes in glycosylated αDG levels at
3 months predicted ambulatory improvements at 9 months, providing
support for the possible use of glycosylated αDG levels as a
surrogate endpoint in the ongoing Phase 3 study for Accelerated
Approval by the FDA.
- 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. 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.
- The Company believes BBP-418 has the
potential to address a population of 7,000 patients in the U.S. and
Europe.
- There are currently no
disease-modifying treatments available for LGMD2I/R9.
- Encaleret – Calcium-sensing
receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type
1 (ADH1):
- In September 2023, the Company
announced proof-of-concept Phase 2b data evaluating the effects of
encaleret on mineral homeostasis in patients with ADH1 were
published in the New England Journal of Medicine in partnership
with the NIH. The results highlighted that encaleret restored
physiologic mineral homeostasis in 13 participants with ADH1,
specifically correcting hypocalcemia and reducing
hypercalciuria.
- Population genetics analyses estimate
approximately 25,000 carriers of gain-of-function variants of the
CaSR, the underlying cause of ADH1, in the U.S. and European
Union.
- The Company has received approval to
begin enrollment for CALIBRATE, its Phase 3 clinical trial of
encaleret, in European Union and Japan, and anticipates sharing
topline data from CALIBRATE in 2024.
- If approved, encaleret could be the
first therapy specifically indicated for the treatment of
ADH1.
- BBP-631 – AAV5 gene therapy
candidate for congenital adrenal hyperplasia (CAH):
- The Phase 1/2 gene therapy trial of
BBP-631 for CAH continues to progress, with the dose-escalation
portion of the study (N=6) fully enrolled; the Company plans to
share data from the program in early 2024.
- CAH is one of the most prevalent
genetic diseases potentially addressable with adeno-associated
virus (AAV) gene therapy, with more than 75,000 cases estimated in
the U.S. and European Union.
- RAS cancer portfolio:
- BBO-8520, an investigational,
next-generation small molecule direct KRASG12C(ON) inhibitor
candidate that is designed to directly bind and inhibit KRASG12C in
both its ON (GTP-bound) and OFF (GDP-bound) conformations, remains
on track to file an IND in 2023.
- The novel, direct KRAS (ON) targeting
mechanism of BBO-8520 was observed to be potentially superior to
KRAS (OFF) by data presented at the recent Triple Meeting,
suggesting scope for a potent, next-generation agent to have an
effect.
- The Company’s PI3Kα:RAS breaker
candidate BBO-10203 and pan-KRAS program remain on track for an IND
and a development candidate selection, respectively, in 2024.
Recent Corporate Updates:
- Multi-year partnership with
Resilience to advance BBP-631, BBP-812 and future gene therapy
treatments: The Company and Resilience signed an agreement
to transfer the manufacturing process for the Company’s lead
AAV-based gene therapy candidates, BBP-631 and BBP-812, to
Resilience’s network of gene therapy manufacturing sites.
Resilience will also be the primary manufacturer for future
clinical projects across the Company’s gene therapy portfolio. The
deal is intended to reduce manufacturing costs, which have
historically accounted for approximately 50%-60% of the Company’s
gene therapy budget.
- $316 million gross proceeds
raised between ATM and PIPE financing: The PIPE financing
(as detailed in the forthcoming S-3 filing) included significant
participation from four of the largest investment management firms
in the U.S., as well as a number of large institutional investors
and existing investors.
Third Quarter 2023 Financial Results:
Cash, Cash Equivalents, Marketable Securities and
Short-Term Restricted Cash
Cash, cash equivalents and short-term restricted cash, totaled
$521.9 million as of September 30, 2023, compared to cash,
cash equivalents, marketable securities and short-term restricted
cash of $466.2 million as of December 31, 2022. The net
increase of $55.7 million in cash, cash equivalents, marketable
securities and short-term restricted cash was primarily
attributable to net proceeds received of $450.3 million from
various equity financing offerings, and $5.2 million from stock
option exercises, primarily offset by net cash used in operating
activities of $402.9 million during the nine months ended
September 30, 2023.
Revenue
Revenue for the three and nine months ended September 30,
2023 was $4.1 million and $7.6 million, respectively, as compared
to $0.3 million and $75.8 million for the same periods in the prior
year, respectively. The net decrease of $68.2 million for the nine
months ended September 30, 2023, compared to the same period
in the prior year, was primarily attributable to the timing of
revenue recognized from the Navire-BMS License Agreement which was
entered into in May 2022.
Operating Costs and Expenses
Operating costs and expenses for the three and nine months ended
September 30, 2023 were $161.8 million and $437.5 million,
respectively, compared to $129.5 million and $458.7 million, for
the same periods in the prior year, respectively.
The overall increase of $32.3 million in operating costs and
expenses for the three months ended September 30, 2023,
compared to the same period in the prior year, was primarily due to
an increase of $32.6 million in research and development and other
expenses (R&D) to advance the Company's pipeline of development
programs, an increase of $4.6 million in selling, general and
administrative (SG&A) expenses to support commercialization
readiness efforts, offset by a decrease of $4.7 million in
restructuring, impairment and related charges.
The overall decrease of $21.2 million in operating costs and
expenses for the nine months ended September 30, 2023,
compared to the same period in the prior year, was primarily due to
a decrease of $28.9 million in restructuring, impairment and
related charges given that the majority of the restructuring
initiatives occurred in the prior year, a decrease of $8.3 million
in SG&A expenses as a result of restructuring initiatives,
offset by an increase of $16.0 million in R&D expenses to
advance the Company's pipeline of development programs.
Restructuring, impairment and related charges for the three and
nine months ended September 30, 2023, amounted to $0.3 million
and $7.2 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 $5.0 million and $36.1 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. The Company expects that
the remaining restructuring, impairment and related charges will be
immaterial through the end of 2023.
Stock-based compensation expenses included in operating costs
and expenses for the three months ended September 30, 2023
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 three months ended September 30, 2022 were
$18.7 million, of which $6.2 million is included in R&D
expenses, and $12.5 million is included in SG&A expenses.
Stock-based compensation expenses included in operating costs
and expenses for the nine months ended September 30, 2023 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.
Stock-based compensation expenses included in operating costs and
expenses for the nine months ended September 30, 2022 were
$71.2 million, of which $29.0 million is included in R&D
expenses, $41.0 million is included in SG&A expenses, and $1.2
million is included in restructuring, impairment and related
charges.
“We were pleased to partner with leading institutional investors
on our PIPE financing last quarter,” said Brian Stephenson, Ph.D.,
CFA, Chief Financial Officer of BridgeBio. “We continue to take
advantage of our optionality in exploring less-dilutive forms of
financing and anticipate that these, in conjunction with the PIPE
financing, could capitalize us to profitability.”
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, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue |
|
$ |
4,091 |
|
|
$ |
338 |
|
|
$ |
7,558 |
|
|
$ |
75,778 |
|
Operating costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research, development and other expenses |
|
|
125,734 |
|
|
|
93,250 |
|
|
|
327,333 |
|
|
|
311,347 |
|
Selling, general and administrative |
|
|
35,777 |
|
|
|
31,188 |
|
|
|
103,007 |
|
|
|
111,327 |
|
Restructuring, impairment and related charges |
|
|
272 |
|
|
|
5,016 |
|
|
|
7,172 |
|
|
|
36,074 |
|
Total operating costs and expenses |
|
|
161,783 |
|
|
|
129,454 |
|
|
|
437,512 |
|
|
|
458,748 |
|
Loss from operations |
|
|
(157,692 |
) |
|
|
(129,116 |
) |
|
|
(429,954 |
) |
|
|
(382,970 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,793 |
|
|
|
2,417 |
|
|
|
12,460 |
|
|
|
3,450 |
|
Interest expense |
|
|
(20,306 |
) |
|
|
(19,825 |
) |
|
|
(61,021 |
) |
|
|
(60,448 |
) |
Gain from sale of priority review voucher, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
107,946 |
|
Other income (expense), net |
|
|
(5,283 |
) |
|
|
6,331 |
|
|
|
(4,408 |
) |
|
|
(12,060 |
) |
Total other income (expense), net |
|
|
(21,796 |
) |
|
|
(11,077 |
) |
|
|
(52,969 |
) |
|
|
38,888 |
|
Net loss |
|
|
(179,488 |
) |
|
|
(140,193 |
) |
|
|
(482,923 |
) |
|
|
(344,082 |
) |
Net loss attributable to
redeemable convertible noncontrolling interests and noncontrolling
interests |
|
|
2,489 |
|
|
|
2,854 |
|
|
|
7,869 |
|
|
|
490 |
|
Net loss attributable to common
stockholders of BridgeBio |
|
$ |
(176,999 |
) |
|
$ |
(137,339 |
) |
|
$ |
(475,054 |
) |
|
$ |
(343,592 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.08 |
) |
|
$ |
(0.93 |
) |
|
$ |
(2.99 |
) |
|
$ |
(2.34 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
|
163,308,632 |
|
|
|
147,937,817 |
|
|
|
158,891,152 |
|
|
|
146,842,453 |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
Stock-based
Compensation |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Research, development and others |
|
$ |
14,144 |
|
|
$ |
6,137 |
|
|
$ |
39,152 |
|
|
$ |
29,046 |
|
Selling, general and
administrative |
|
|
13,086 |
|
|
|
12,521 |
|
|
|
38,731 |
|
|
|
41,026 |
|
Restructuring, impairment and
related charges |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,172 |
|
Total stock-based
compensation |
|
$ |
27,230 |
|
|
$ |
18,658 |
|
|
$ |
77,883 |
|
|
$ |
71,244 |
|
BRIDGEBIO PHARMA,
INC.Condensed Consolidated Balance
Sheets(In thousands)
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
Assets |
|
(Unaudited) |
|
|
(1) |
|
|
Cash and cash equivalents and marketable securities |
|
$ |
505,213 |
|
|
$ |
428,269 |
|
|
Investment in equity
securities |
|
|
38,052 |
|
|
|
43,653 |
|
|
Receivable from licensing and
collaboration agreements |
|
|
5,170 |
|
|
|
17,079 |
|
|
Short-term restricted
cash |
|
|
16,652 |
|
|
|
37,930 |
|
|
Prepaid expenses and other
current assets |
|
|
22,583 |
|
|
|
21,922 |
|
|
Property and equipment,
net |
|
|
12,413 |
|
|
|
14,569 |
|
|
Operating lease right-of-use
assets |
|
|
9,332 |
|
|
|
10,678 |
|
|
Intangible assets, net |
|
|
26,917 |
|
|
|
28,712 |
|
|
Other assets |
|
|
18,676 |
|
|
|
20,224 |
|
|
Total assets |
|
$ |
655,008 |
|
|
$ |
623,036 |
|
|
Liabilities,
Redeemable Convertible Noncontrolling Interests and Stockholders’
Deficit |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,472 |
|
|
$ |
11,558 |
|
|
Accrued and other
liabilities |
|
|
97,456 |
|
|
|
106,195 |
|
|
Operating lease
liabilities |
|
|
13,949 |
|
|
|
15,949 |
|
|
2029 Notes |
|
|
736,422 |
|
|
|
734,988 |
|
|
2027 Notes |
|
|
542,938 |
|
|
|
541,634 |
|
|
Term loan |
|
|
441,721 |
|
|
|
430,993 |
|
|
Other long-term
liabilities |
|
|
11,785 |
|
|
|
26,643 |
|
|
Redeemable convertible
noncontrolling interests |
|
|
1,403 |
|
|
|
(1,589 |
|
) |
Total BridgeBio stockholders'
deficit |
|
|
(1,207,543 |
) |
|
|
(1,254,617 |
|
) |
Noncontrolling interests |
|
|
12,405 |
|
|
|
11,282 |
|
|
Total liabilities, redeemable convertible noncontrolling interests
and stockholders’ deficit |
|
$ |
655,008 |
|
|
$ |
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)
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
Operating
activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(482,923 |
) |
|
$ |
(344,082 |
) |
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
|
Stock-based compensation |
|
|
71,685 |
|
|
|
69,770 |
|
Depreciation and amortization |
|
|
4,909 |
|
|
|
5,111 |
|
Noncash lease expense |
|
|
3,024 |
|
|
|
4,017 |
|
Accrual of payment-in-kind interest on term loan |
|
|
6,742 |
|
|
|
— |
|
Loss on deconsolidation of PellePharm |
|
|
1,241 |
|
|
|
— |
|
Loss from investment in equity securities, net |
|
|
2,951 |
|
|
|
12,969 |
|
Fair value of shares issued under a license agreement |
|
|
— |
|
|
|
4,567 |
|
Accretion of debt |
|
|
6,724 |
|
|
|
6,469 |
|
Fair value adjustment of warrants |
|
|
52 |
|
|
|
1,446 |
|
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 |
|
|
(384 |
) |
|
|
670 |
|
Changes in operating assets and
liabilities: |
|
|
|
|
|
|
Receivable from licensing and collaboration agreements |
|
|
11,909 |
|
|
|
(832 |
) |
Prepaid expenses and other current assets |
|
|
(980 |
) |
|
|
4,072 |
|
Other assets |
|
|
1,443 |
|
|
|
10,095 |
|
Accounts payable |
|
|
(3,404 |
) |
|
|
(1,725 |
) |
Accrued compensation and benefits |
|
|
(4,156 |
) |
|
|
(9,122 |
) |
Accrued research and development liabilities |
|
|
(10,544 |
) |
|
|
452 |
|
Operating lease liabilities |
|
|
(3,671 |
) |
|
|
(4,819 |
) |
Deferred revenue |
|
|
(4,464 |
) |
|
|
16,969 |
|
Accrued professional and other liabilities |
|
|
(3,055 |
) |
|
|
1,241 |
|
Net cash used in operating
activities |
|
|
(402,901 |
) |
|
|
(326,251 |
) |
Investing
activities: |
|
|
|
|
|
|
Purchases of marketable
securities |
|
|
(29,726 |
) |
|
|
(134,635 |
) |
Maturities of marketable
securities |
|
|
82,550 |
|
|
|
452,819 |
|
Purchases of investment in equity
securities |
|
|
(78,314 |
) |
|
|
(26,312 |
) |
Sales of investment in equity
securities |
|
|
80,963 |
|
|
|
28,830 |
|
Decrease in cash and cash
equivalents resulting from deconsolidation of PellePharm |
|
|
(503 |
) |
|
|
— |
|
Payment for an 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 |
|
|
(871 |
) |
|
|
(4,020 |
) |
Net cash provided by investing
activities |
|
|
54,099 |
|
|
|
435,182 |
|
Financing
activities: |
|
|
|
|
|
|
Proceeds from issuance of common
stock through Private Placement offering, net |
|
|
241,250 |
|
|
|
— |
|
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 |
|
|
|
— |
|
Transactions with noncontrolling
interests |
|
|
1,500 |
|
|
|
— |
|
Repayment of term loan |
|
|
— |
|
|
|
(20,486 |
) |
Proceeds from BridgeBio common
stock issuances under ESPP |
|
|
3,397 |
|
|
|
2,558 |
|
Repurchase of shares to satisfy
tax withholding |
|
|
(4,325 |
) |
|
|
(1,072 |
) |
Issuance costs associated with
term loan |
|
|
— |
|
|
|
(1,120 |
) |
Proceeds from stock option
exercises, net of repurchases |
|
|
5,222 |
|
|
|
609 |
|
Net cash provided by (used in)
financing activities |
|
|
456,058 |
|
|
|
(19,511 |
) |
Net increase in cash, cash
equivalents and restricted cash |
|
|
107,256 |
|
|
|
89,420 |
|
Cash, cash equivalents and
restricted cash at beginning of period |
|
|
416,884 |
|
|
|
396,365 |
|
Cash, cash equivalents and
restricted cash at end of period |
|
$ |
524,140 |
|
|
$ |
485,785 |
|
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
Supplemental Disclosure
of Cash Flow Information: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
50,826 |
|
|
$ |
47,575 |
|
Supplemental Disclosures
of Noncash Investing and Financing Information: |
|
|
|
|
|
|
Unpaid issuance cost on Private
Placement offering |
|
$ |
455 |
|
|
$ |
— |
|
Payment-in-kind interest added to
principal of term loan |
|
$ |
— |
|
|
$ |
8,503 |
|
Unpaid property and
equipment |
|
$ |
192 |
|
|
$ |
60 |
|
Transfers (to) from
noncontrolling interests |
|
$ |
(8,313 |
) |
|
$ |
1,153 |
|
Reconciliation of Cash,
Cash Equivalents and Restricted Cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
505,213 |
|
|
$ |
483,235 |
|
Short-term restricted cash |
|
|
16,652 |
|
|
|
— |
|
Restricted cash — Included in
“Prepaid expenses and other current assets” |
|
|
— |
|
|
|
140 |
|
Restricted cash — Included in
“Other assets” |
|
|
2,275 |
|
|
|
2,410 |
|
Total cash, cash equivalents and restricted cash at end of period
shown in the condensed consolidated statements of cash flows |
|
$ |
524,140 |
|
|
$ |
485,785 |
|
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,”
“estimates,” “expects,” “intends,” “may,” “plans,” “projects,”
“seeks,” “should,” “will,” “on track”, “remains” 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 statement in Dr. Kumar’s quote
regarding our data, pipeline and potential product launches; the
timing and success of our clinical development programs, including
the progress of our ongoing and planned clinical trials of
acoramidis for patients with ATTR-CM, our plans to file an NDA for
acoramidis with the FDA by the end of 2023, and to file marketing
authorization applications with additional regulatory authorities
in 2024; the expected initiation of a Phase 3 clinical trial of
infigratinib in children with achondroplasia by the end of 2023;
the potential for glycosylated αDG to serve as a surrogate endpoint
for Accelerated Approval in FORTIFY, the ongoing global phase 3
trial registrational clinical trial of BBP-418 for LGMD2i, the
plans of engaging with regulatory authorities, and the
potentially-addressable population of BBP-418 in the United States
and Europe; the potential of infigratinib for achondroplasia to
have a potential of best-in-class efficacy with well-tolerated
safety profile and to capture a significant share of the market
based on blinded market research, if approved; the Company’s
finding that ADH1 may be the most common presentation of
nonsurgical hypoparathyroidism, the timing and status of Phase 3
CALIBRATE registrational trial of encaleret for ADH1, the timing of
announcement of topline data from CALIBRATE in 2024, the estimated
population of carriers of gain-of-function variants of the CaSR,
the underlying cause of ADH1, in the U.S. and European Union, and
the success of encaleret (if approved), including its potential to
be the first therapy specifically indicated for the treatment of
ADH1; the continuation and progress of our ongoing Phase 1/2 trial
of BBP-631 for CAH, with plans to share data from the program in
early 2024; the continued development, the timing, progression and
success of the RAS franchise, including an IND application planned
for KRASG12C (ON) inhibitor BBO-8520 in 2023, the intention to file
an IND for PI3Kα:RAS breaker candidate BBO-10203 in 2024 and the
planned development candidate selection for the pan-KRAS program in
2024; the success and anticipated cost reductions of our gene
therapy manufacturing partnership with Resilience; potential
financing activities and potential capitalization to profitability,
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 Annual Report on Form 10-K
for the year ended December 31, 2022 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
Balicontact@bridgebio.com(650)-789-8220
BridgeBio Pharma (NASDAQ:BBIO)
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