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
first quarter ended March 31, 2024, and provided an update on the
Company’s operations.
“In addition to the important scientific work we have done to
advance our patient mission this quarter, we have also taken a
first step towards streamlining our firm and thereby unlocking
value for patients and investors alike,” said Neil Kumar, Ph.D.,
founder and CEO of BridgeBio. “We believe the launch of BBOT better
aligns investors with an opportunity that was being hidden in our
pipeline, and our partnership with these new investors enables us
to prosecute these oncology programs more quickly and with higher
fidelity. In tandem with our progress in corporate simplification
and balance sheet strengthening, we continue to prepare for what we
believe will be a world class launch this year in ATTR-CM and we
continue to enroll our achondroplasia, ADH1 and LGMD2I/R9 clinical
trials, all of which are expected to complete enrollment this
year.”
BridgeBio’s late stage programs:
- Acoramidis (AG10) – Transthyretin (TTR) stabilizer for
transthyretin amyloid cardiomyopathy (ATTR-CM):
- The EMA accepted the Company’s MAA for acoramidis for review,
with an expected approval in 2025. This is in addition to the
Prescription Drug User Fee Act (PDUFA) date of November 29, 2024
set by the U.S. FDA for the Company’s NDA for acoramidis for the
treatment of ATTR-CM.
- In March 2024, the Company entered into a licensing agreement
granting Bayer exclusive rights to commercialize acoramidis for
ATTR-CM in Europe; in exchange, BridgeBio is entitled to receive
among other consideration:
- Tiered royalties beginning in the low-thirties percent,
and
- Up to $310 million in upfront and near-term milestone payments,
as well as additional sales milestones.
- The Company presented cardiac magnetic resonance imaging
evidence from an exploratory substudy where treatment with
acoramidis was associated with possible cardiac structural and
functional improvement compared with placebo, with potential
cardiac amyloid regression. This evidence is consistent with
clinical improvement observed in the Company’s ATTRibute-CM Phase 3
study of acoramidis in patients with ATTR-CM.
- Additional detailed results of the Company’s ATTRibute-CM study
are planned for presentation at 2024 medical meetings, including
four abstracts accepted for presentation at the European Society of
Cardiology Heart Failure conference in May 2024, and eleven
abstracts accepted for presentation at the International Symposium
on Amyloidosis in May 2024.
- Low-dose infigratinib – FGFR1-3 inhibitor for
achondroplasia and hypochondroplasia:
- The PROPEL 3 global Phase 3 registrational study of
infigratinib in achondroplasia continues to enroll; study
completion continues to be anticipated for 2025.
- The Company anticipates initiating its clinical program for
hypochondroplasia in 2024, as part of its commitment to exploring
the potential of infigratinib on the wider medical and functional
impacts of achondroplasia, hypochondroplasia and other skeletal
dysplasias.
- BBP-418 – Glycosylation substrate for limb-girdle
muscular dystrophy type 2I/R9 (LGMD2I/R9):
- 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.
- FORTIFY, the global Phase 3 registrational trial of BBP-418 in
LGMD2I/R9, continues to enroll in the U.S., Europe and Australia.
Full enrollment of the interim analysis population is expected in
2024.
- 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.
Recent Corporate Updates:
- The Company announced the launch of BridgeBio Oncology
Therapeutics (BBOT) with a $200 million private financing to
accelerate the development of its novel precision oncology
pipeline.
- The $200 million financing was led by Cormorant Asset
Management and co-led by Omega Funds, with participation from
affiliates of Deerfield Management, GV (Google Ventures), EcoR1
Capital, Wellington Management, Enavate Sciences, Surveyor Capital
(a Citadel company), Aisling Capital, Casdin Capital, and Longwood
Fund.
- BBOT will be led by Eli Wallace, Ph.D. as CEO and Pedro
Beltran, Ph.D. as CSO; the Board of Directors for BBOT will be
chaired by Frank McCormick, Ph.D., David A. Wood Distinguished
Professor of Tumor Biology and Cancer Research at UCSF and advisor
to the National Cancer Institute’s RAS Initiative at Frederick
National Laboratory for Cancer Research. Raymond Kelleher, M.D.,
Ph.D., Managing Director Cormorant Asset Management, Michelle Doig,
Partner, Omega Funds, and Neil Kumar, Ph.D., CEO of BridgeBio will
serve as directors.
First 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 $519.8 million as of March 31, 2024,
compared to $392.6 million of cash, cash equivalents and short-term
restricted cash as of December 31, 2023. The $127.2 million
net increase in cash, cash equivalents, marketable securities and
short-term restricted cash was primarily attributable to net
proceeds received from the term loan under the credit facility with
Blue Owl of $437.7 million, net proceeds received of $315.3 million
from various equity financings, 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 were primarily offset by refinancing of the
Company’s previous senior secured credit and inclusive of
prepayment fees and exit-related costs in aggregate of $473.4
million, net cash used in operating activities of $219.5 million
and purchases of equity securities of $20.3 million during the
three months ended March 31, 2024.
Revenue
Revenue for the three months ended March 31, 2024, were
$211.1 million, as compared to $1.8 million for the same period in
the prior year. The $209.3 million net increase for the three
months ended March 31, 2024, compared to the same period in
the prior year, was primarily due to the recognition of
non-refundable upfront payments under the Bayer and the Kyowa Kirin
exclusive license agreements. The remaining license and services
revenue was recognized in connection with the Navire-BMS License
Agreement, which was entered into in May 2022 and for which BMS
provided notice of termination in March 2024 with a termination
effective in June 2024.
Operating Costs and Expenses
Operating costs and expenses for the three months ended
March 31, 2024 were $210.8 million compared to $128.0 million
for the same period in the prior year.
The overall increase of $82.8 million in operating costs and
expenses for the three months ended March 31, 2024, compared
to the same period in the prior year, was primarily due to an
increase of $48.1 million in research and development and other
expenses (R&D) to advance the Company’s pipeline of development
programs, and an increase of $34.7 million in selling, general and
administrative (SG&A) expenses mainly to support
commercialization readiness efforts. Operating costs and expenses
for the three months ended March 31, 2024, include $22.5 million of
nonrecurring deal-related costs for transactions that were closed
during the period.
Restructuring, impairment and related charges for the three
months ended March 31, 2024 amounted to $3.4 million. 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 period in the prior year was $3.4 million.
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 March 31, 2024 were
$28.9 million, of which $12.8 million is included in R&D
expenses, and $16.1 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 $23.5 million,
of which $11.8 million is included in R&D expenses, and $11.7
million is included in SG&A expenses.
“With our recent equity financing activities, our licensing deal
with Bayer for European commercial rights to acoramidis, our
royalty funding agreement for $500 million upon FDA approval of
acoramidis, and now the private financing of BBOT to advance our
oncology pipeline into the clinic, we are in a strong financial
position to launch acoramidis in the U.S. at the end of this year
and deliver three Phase 3 readouts in 2025,” said Brian Stephenson,
Ph.D., CFA, Chief Financial Officer of BridgeBio.
BRIDGEBIO PHARMA, INC.Condensed
Consolidated Statements of Operations(in
thousands, except shares and per share amounts) |
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
2023 |
|
|
(Unaudited) |
|
Revenue |
$ |
211,120 |
|
|
$ |
1,826 |
|
Operating costs and
expenses: |
|
|
|
|
|
Research, development and other expenses |
|
141,570 |
|
|
|
93,512 |
|
Selling, general and administrative |
|
65,807 |
|
|
|
31,108 |
|
Restructuring, impairment and related charges |
|
3,400 |
|
|
|
3,369 |
|
Total operating costs and expenses |
|
210,777 |
|
|
|
127,989 |
|
Income (loss) from
operations |
|
343 |
|
|
|
(126,163 |
) |
Other expense, net: |
|
|
|
|
|
Interest income |
|
4,075 |
|
|
|
4,153 |
|
Interest expense |
|
(23,471 |
) |
|
|
(20,121 |
) |
Loss on extinguishment of debt |
|
(26,590 |
) |
|
|
— |
|
Other income (expense), net |
|
9,483 |
|
|
|
(601 |
) |
Total other expense, net |
|
(36,503 |
) |
|
|
(16,569 |
) |
Net loss |
|
(36,160 |
) |
|
|
(142,732 |
) |
Net loss attributable to
redeemable convertible noncontrolling interests and noncontrolling
interests |
|
944 |
|
|
|
2,576 |
|
Net loss attributable to common
stockholders of BridgeBio |
$ |
(35,216 |
) |
|
$ |
(140,156 |
) |
Net loss per share, basic and
diluted |
$ |
(0.20 |
) |
|
$ |
(0.92 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
178,705,310 |
|
|
|
152,645,635 |
|
|
Three Months Ended March 31, |
|
Stock-based
Compensation |
2024 |
|
2023 |
|
|
(Unaudited) |
|
Research, development and other expenses |
$ |
12,779 |
|
$ |
11,779 |
|
Selling, general and
administrative |
|
16,071 |
|
|
11,698 |
|
Total stock-based compensation |
$ |
28,850 |
|
$ |
23,477 |
|
BRIDGEBIO PHARMA,
INC.Condensed Consolidated Balance
Sheets(In thousands)
|
March 31, |
|
|
December 31, |
|
2024 |
|
|
2023 |
|
Assets |
(Unaudited) |
|
|
(1 |
) |
Cash and cash equivalents and marketable securities |
$ |
519,691 |
|
|
$ |
375,935 |
|
Investments in equity
securities |
|
- |
|
|
|
58,949 |
|
Receivables from licensing and
collaboration agreements |
|
235,494 |
|
|
|
1,751 |
|
Short-term restricted
cash |
|
131 |
|
|
|
16,653 |
|
Prepaid expenses and other
current assets |
|
28,108 |
|
|
|
24,305 |
|
Property and equipment,
net |
|
11,414 |
|
|
|
11,816 |
|
Operating lease right-of-use
assets |
|
8,052 |
|
|
|
8,027 |
|
Intangible assets, net |
|
25,721 |
|
|
|
26,319 |
|
Other assets |
|
20,722 |
|
|
|
22,625 |
|
Total assets |
$ |
849,333 |
|
|
$ |
546,380 |
|
Liabilities,
Redeemable Convertible Noncontrolling Interests and Stockholders’
Deficit |
|
|
|
|
Accounts payable |
$ |
4,728 |
|
|
$ |
10,655 |
|
Accrued and other
liabilities |
|
118,248 |
|
|
|
122,965 |
|
Operating lease
liabilities |
|
12,841 |
|
|
|
13,109 |
|
Deferred revenue |
|
33,847 |
|
|
|
9,823 |
|
2029 Notes, net |
|
737,392 |
|
|
|
736,905 |
|
2027 Notes, net |
|
543,823 |
|
|
|
543,379 |
|
Term loan, net |
|
434,717 |
|
|
|
446,445 |
|
Other long-term
liabilities |
|
595 |
|
|
|
5,634 |
|
Redeemable convertible
noncontrolling interests |
|
525 |
|
|
|
478 |
|
Total BridgeBio stockholders'
deficit |
|
(1,049,528 |
) |
|
|
(1,354,257 |
) |
Noncontrolling interests |
|
12,145 |
|
|
|
11,244 |
|
Total liabilities, redeemable convertible noncontrolling interests
and stockholders’ deficit |
$ |
849,333 |
|
|
$ |
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) |
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
2023 |
|
Operating
activities: |
|
|
|
|
|
Net loss |
$ |
(36,160 |
) |
|
$ |
(142,732 |
) |
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
Loss on extinguishment of debt |
|
26,590 |
|
|
|
— |
|
Stock-based compensation |
|
17,057 |
|
|
|
21,907 |
|
Accretion of debt |
|
2,015 |
|
|
|
2,338 |
|
Depreciation and amortization |
|
1,596 |
|
|
|
1,633 |
|
Noncash lease expense |
|
1,069 |
|
|
|
1,032 |
|
Accrual of payment-in-kind interest on term loan |
|
— |
|
|
|
3,339 |
|
Loss on deconsolidation of PellePharm |
|
— |
|
|
|
1,241 |
|
Gain from investment in equity securities, net |
|
(8,136 |
) |
|
|
(964 |
) |
Other noncash adjustments |
|
1,631 |
|
|
|
(314 |
) |
Changes in operating assets and
liabilities: |
|
|
|
|
|
Receivables from licensing and collaboration agreements |
|
(233,743 |
) |
|
|
6,318 |
|
Prepaid expenses and other current assets |
|
(3,345 |
) |
|
|
(3,542 |
) |
Other assets |
|
444 |
|
|
|
(483 |
) |
Accounts payable |
|
(5,927 |
) |
|
|
(3,800 |
) |
Accrued compensation and benefits |
|
(14,969 |
) |
|
|
(18,369 |
) |
Accrued research and development liabilities |
|
11,168 |
|
|
|
(2,556 |
) |
Operating lease liabilities |
|
(1,595 |
) |
|
|
(1,250 |
) |
Deferred revenue |
|
24,024 |
|
|
|
(1,748 |
) |
Accrued professional and other liabilities |
|
(1,256 |
) |
|
|
(6,372 |
) |
Net cash used in operating
activities |
|
(219,537 |
) |
|
|
(144,322 |
) |
Investing
activities: |
|
|
|
|
|
Purchases of marketable
securities |
|
(44,395 |
) |
|
|
— |
|
Maturities of marketable
securities |
|
— |
|
|
|
18,000 |
|
Purchases of investments in
equity securities |
|
(20,271 |
) |
|
|
(47,474 |
) |
Proceeds from sales of
investments in equity securities |
|
63,229 |
|
|
|
42,287 |
|
Proceeds from special cash
dividends received from investments in equity securities |
|
25,682 |
|
|
|
— |
|
Payment for an intangible
asset |
|
(797 |
) |
|
|
— |
|
Purchases of property and
equipment |
|
(695 |
) |
|
|
(12 |
) |
Decrease in cash and cash
equivalents resulting from deconsolidation of PellePharm |
|
— |
|
|
|
(503 |
) |
Net cash provided by investing
activities |
|
22,753 |
|
|
|
12,298 |
|
Financing
activities: |
|
|
|
|
|
Proceeds from term loan under
Financing Agreement |
|
450,000 |
|
|
|
— |
|
Issuance costs and discounts
associated with term loan under Financing Agreement |
|
(12,254 |
) |
|
|
— |
|
Repayment of term loan under Loan
and Security Agreement |
|
(473,417 |
) |
|
|
— |
|
Proceeds from issuance of common
stock through public offerings, net |
|
315,254 |
|
|
|
143,016 |
|
Proceeds from BridgeBio common
stock issuances under ESPP |
|
2,364 |
|
|
|
1,809 |
|
Proceeds from stock option
exercises, net of repurchases |
|
537 |
|
|
|
193 |
|
Repurchase of RSU shares to
satisfy tax withholding |
|
(2,936 |
) |
|
|
(512 |
) |
Other financing activities |
|
— |
|
|
|
5,743 |
|
Net cash provided by financing
activities |
|
279,548 |
|
|
|
150,249 |
|
Net increase in cash, cash
equivalents and restricted cash |
|
82,764 |
|
|
|
18,225 |
|
Cash, cash equivalents and
restricted cash at beginning of period |
|
394,732 |
|
|
|
416,884 |
|
Cash, cash equivalents and
restricted cash at end of period |
$ |
477,496 |
|
|
$ |
435,109 |
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
2023 |
|
Supplemental Disclosure
of Cash Flow Information: |
|
|
|
|
|
Cash paid for interest |
$ |
35,315 |
|
|
$ |
22,059 |
|
Supplemental Disclosures
of Noncash Investing and Financing Information: |
|
|
|
|
|
Unpaid issuance costs associated
with term loan under Financing Agreement |
$ |
3,732 |
|
|
$ |
— |
|
Unpaid public offering issuance
costs |
$ |
513 |
|
|
$ |
— |
|
Deferred and unpaid issuance
costs recorded to "Accrued professional and other accrued
liabilities" |
$ |
458 |
|
|
$ |
— |
|
Unpaid property and
equipment |
$ |
70 |
|
|
$ |
96 |
|
Transfers to noncontrolling
interests |
$ |
(1,857 |
) |
|
$ |
(2,843 |
) |
Reconciliation of Cash,
Cash Equivalents and Restricted Cash: |
|
|
|
|
|
Cash and cash equivalents |
$ |
475,222 |
|
|
$ |
407,368 |
|
Restricted cash |
|
131 |
|
|
|
25,503 |
|
Restricted cash — Included in
“Other assets” |
|
2,143 |
|
|
|
2,238 |
|
Total cash, cash equivalents and restricted cash at end of period
shown in the condensed consolidated statements of cash flows |
$ |
477,496 |
|
|
$ |
435,109 |
|
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 the Company’s
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 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 reviews by the FDA and the EMA; 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, presenting additional detailed results
of ATTRibute-CM study at medical meetings; the potential payments
we may receive under the recent license agreement with Bayer; the
continuation of PROPEL 3, the Company’s Phase 3 study of
infigratinib for achondroplasia and the expected timing for full
enrollment in the study; the Company’s commitment to exploring the
potential of infigratinib and the expectation and timing of the
initiation of 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 ongoing enrollment in the
United States, 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 timing
for sharing topline data from CALIBRATE; the expectation to
accelerate the development of the Company’s novel precision
oncology pipeline; 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
BridgeBio Pharma (NASDAQ:BBIO)
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