BridgeBio Pharma, Inc. (Nasdaq: BBIO), a clinical-stage
biopharmaceutical company founded to discover, create, test and
deliver meaningful medicines for patients with genetic diseases and
cancers with clear genetic drivers, today reported its financial
results for the third quarter ended September 30, 2020 and provided
an update on the company’s operations.
BridgeBio announced a merger agreement last month with Eidos
Therapeutics, Inc. (Nasdaq: EIDX), which is developing acoramidis
(formerly AG10), a potential best-in-class transthyretin (TTR)
stabilizer for patients with TTR amyloid (ATTR) cardiomyopathy and
polyneuropathy. With this transaction, BridgeBio intends to fully
and formally welcome Eidos back into its vibrant ecosystem of
innovation and has agreed to acquire all of the outstanding common
stock of Eidos it does not already own. The company expects to
complete the proposed transaction in the first quarter of 2021,
subject to certain conditions, including the receipt of stockholder
approvals.
Since the company’s last quarterly update, BridgeBio had its
first new drug application (NDA) accepted by the U.S. Food and Drug
Administration (FDA) under Priority Review designation and
initiated two new clinical trials, including a Phase 2 trial of
encaleret (calcium sensing receptor antagonist) for autosomal
dominant hypocalcemia type 1 (ADH1), one of BridgeBio’s four core
value driver programs. It also entered into collaboration
agreements with the Salk Institute and the University of Colorado
Anschutz Medical Campus to advance the development of new therapies
for genetically driven diseases.
BridgeBio held its first-ever R&D Day on September 29, 2020,
which focused on the company’s drug engineering platform, its
targeted oncology portfolio, and four highlighted programs where
clinical data are anticipated in the next 12 to 18 months –
acoramidis for ATTR, low-dose infigratinib (FGFR inhibitor) for
achondroplasia, AAV5 gene therapy for congenital adrenal
hyperplasia (CAH), and encaleret for ADH1.
“We are nearing a significant inflection point as a company as
we approach the start of 2021. Our four key programs have critical
data readouts within the next year and a half – in ATTR,
achondroplasia, CAH and ADH1. We are progressing 17 ongoing
clinical trials and we are preparing for commercialization, to
bring our first investigational therapy to patients. There has
never been a more exciting moment to be at the forefront of the
revolution taking place in genetic medicine,” said BridgeBio CEO
and founder Neil Kumar, Ph.D.
Recent pipeline progress and corporate
updates:
- BridgeBio and Eidos Therapeutics enter
into merger
agreement: BridgeBio to acquire
all outstanding shares of common stock of Eidos it does not already
own; agreement unanimously approved by special committee of Eidos’
independent directors. Transaction removes the operational
complexity of the current ownership structure and allows BridgeBio
to fully invest in opportunities around the investigational drug,
acoramidis, including subsequent studies to potentially broaden the
evidence for its usage, and accelerate its commercial development
using BridgeBio’s established infrastructure. Proposed transaction
expected to be completed in the first quarter of 2021, subject to
certain conditions, including approval by both BridgeBio and Eidos
stockholders.
- Fosdenopterin (formerly
BBP-870/ORGN001) – Synthetic cPMP
for molybdenum cofactor deficiency
(MoCD) Type A: FDA
acceptance of NDA under Priority Review designation with
Breakthrough Therapy Designation and Rare Pediatric Disease
Designation previously granted. There are currently no approved
therapies for the treatment of MoCD Type A, which results in severe
and irreversible neurological injury for infants and children. This
is BridgeBio’s first NDA acceptance.
- New academic partnerships: Established
collaboration agreements with the Salk Institute and the University
of Colorado Anschutz Medical Campus to advance the discovery of
therapies for genetically driven diseases.
- BridgeBio Pharma R&D Day: Held a virtual
R&D Day on September 29, 2020. Presentation replay can be found
on BridgeBio’s investor website here.
Major milestones anticipated over the next 12-18 months
for BridgeBio’s four core value
drivers:
- Acoramidis (AG10) – TTR stabilizer for
ATTR: Completed screening in September for pivotal
Phase 3 ATTRibute-CM clinical trial of acoramidis in patients with
ATTR cardiomyopathy. The study enrolled more than 600 subjects with
either wild-type or variant TTR across more than 80 sites in 18
countries. Topline results from Part A of the ATTRibute-CM trial
are expected in late 2021 or early 2022 and from Part B in 2023. If
Part A is successful, intend to file for regulatory approval of
acoramidis in 2022.
- Low-dose
infigratinib – FGFR1-3 inhibitor for
achondroplasia: Remain on track to report initial data
from the ongoing Phase 2 dose ranging study by end of 2021.
Achondroplasia is the most common form of genetic short stature and
one of the most commonly known genetic diseases, with 55,000 cases
in the United States and European Union. Low-dose infigratinib is
the only known therapy in development for achondroplasia that
targets the disease at its genetic source and the only orally
administered product candidate in clinical stage development.
- Encaleret –
CaSR antagonist for
ADH1: Initiated Phase 2 clinical study and dosed
first patients, with topline proof-of-concept results anticipated
in 2021. If the development program is successful, encaleret would
be the first approved therapy for ADH1, a condition caused by gain
of function variants in the CaSR gene estimated to be carried by
12,000 individuals in the United States.
- BBP-631 – AAV5 gene therapy candidate for
CAH: Investigational New Drug (IND)
application-enabling studies for AAV gene therapy proceeding.
Remain on track to initiate a first in human Phase 1/2 study and
report initial data in 2021. CAH is one of the most prevalent
genetic diseases thought to be addressable with AAV gene therapy,
with more than 75,000 cases in the United States and European
Union.
Third quarter 2020 financial results:
Cash, Cash Equivalents and Marketable
Securities
Cash, cash equivalents and marketable securities, excluding
restricted cash, totaled $710.7 million as of September 30, 2020,
compared to $577.1 million at December 31, 2019. The net increase
in cash balance of $133.6 million reflects $537.0 million in net
proceeds received from the issuance of our 2.50% Convertible Senior
Notes due 2027 (2027 Notes), $24.1 million in net proceeds received
from Eidos’ at-the-market issuance of shares, offset by payment of
$75.0 million to repurchase BridgeBio shares in capped call
transactions in connection with the issuance of our 2027 Notes,
$49.3 million payment related to capped call option, $13.3 million
payments of interest on our debts, and $289.9 million primarily
related to operating expenses.
Cash, cash equivalents and marketable securities, excluding
restricted cash, decreased by $130.2 million compared to our
balance as of June 30, 2020, which was $840.9 million. The decrease
in cash reflects $9.2 million payments of interests on our debts
and $121.0 million primarily related to operating expenses.
Operating Expenses
Operating expenses for the three and nine months ended September
30, 2020 were $128.1 million and $355.1 million, respectively, as
compared to $81.3 million and $214.3 million, respectively, for the
same periods in the prior year. The increases in operating expenses
of $46.8 million and $140.8 million during the respective periods
were attributable to the increase in external-related costs and
increase in headcount to support the progression in our research
and development programs, including our increasing research
pipelines, and overall growth of our operations.
Operating expenses for the three months ended September 30, 2020
increased by $3.5 million when compared to the operating expenses
for the three months ended June 30, 2020 of $124.6 million.
Our research and development expenses have not been
significantly impacted by the global outbreak of COVID-19 for the
periods presented. While we experienced some initial delays in
certain of our clinical enrollment and trial commencement
activities, we continue to adapt in this unprecedented time to
enable alternative site, telehealth and home visits, at home drug
delivery, as well as mitigation strategies with our contract
manufacturing organizations. The longer-term impact of COVID-19 on
our operating expenses is currently unknown.
|
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, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
License revenue |
$ 8,127 |
|
|
$ 26,741 |
|
|
$ 8,127 |
|
|
$ 26,741 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of license revenue |
|
— |
|
|
|
2,500 |
|
|
|
— |
|
|
|
2,500 |
|
Research and development |
|
92,050 |
|
|
|
55,278 |
|
|
|
246,873 |
|
|
|
152,462 |
|
General and administrative |
|
36,016 |
|
|
|
23,495 |
|
|
|
108,247 |
|
|
|
59,381 |
|
Total operating expenses |
|
128,066 |
|
|
|
81,273 |
|
|
|
355,120 |
|
|
|
214,343 |
|
Loss from operations |
|
(119,939 |
) |
|
|
(54,532 |
) |
|
|
(346,993 |
) |
|
|
(187,602 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
Interest income |
|
692 |
|
|
|
2,736 |
|
|
|
3,567 |
|
|
|
6,505 |
|
Interest expense |
|
(10,929 |
) |
|
|
(2,113 |
) |
|
|
(25,693 |
) |
|
|
(5,725 |
) |
Share in net loss of equity method investments |
|
— |
|
|
|
(6,589 |
) |
|
|
— |
|
|
|
(16,144 |
) |
Other income (expense) |
|
9 |
|
|
|
(166 |
) |
|
|
(1,344 |
) |
|
|
(1,468 |
) |
Total other income (expense), net |
|
(10,228 |
) |
|
|
(6,132 |
) |
|
|
(23,470 |
) |
|
|
(16,832 |
) |
Net loss |
|
(130,167 |
) |
|
|
(60,664 |
) |
|
|
(370,463 |
) |
|
|
(204,434 |
) |
Net loss attributable to redeemable convertible
noncontrolling interests and noncontrolling interests |
|
14,308 |
|
|
|
684 |
|
|
|
41,720 |
|
|
|
17,305 |
|
Net loss attributable to
common Stockholders of BridgeBio |
$ (115,859 |
) |
|
$ (59,980 |
) |
|
$ (328,743 |
) |
|
$ (187,129 |
) |
Net loss per share, basic and
diluted |
$ (0.98 |
) |
|
$ (0.51 |
) |
|
$ (2.79 |
) |
|
$ (1.86 |
) |
Weighted-average shares used in
computing net loss per share, basic and
diluted |
|
118,168,063 |
|
|
|
117,071,188 |
|
|
|
117,663,038 |
|
|
|
100,855,481 |
|
|
|
BRIDGEBIO PHARMA, INC.Condensed Consolidated
Balance Sheets(In thousands) |
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
|
2019 |
|
Assets |
(Unaudited) |
|
|
(1) |
|
Cash and cash equivalents and
marketable securities (2) |
$ 710,681 |
|
$ 577,137 |
|
Receivable from a related
party |
|
8,000 |
|
|
2,845 |
|
Prepaid expenses and other
current assets |
|
26,703 |
|
|
19,784 |
|
Property and equipment,
net |
|
16,182 |
|
|
5,625 |
|
Operating lease right-of-use
assets |
|
9,644 |
|
|
— |
|
Other assets |
|
16,483 |
|
|
26,288 |
|
Total assets |
$ 787,693 |
|
$ 631,679 |
|
Liabilities,
Redeemable Convertible Noncontrolling
Interests and Stockholders’ Equity |
|
|
|
Accounts payable |
$ 9,839 |
|
$ 8,852 |
|
Accrued liabilities |
|
57,053 |
|
|
39,455 |
|
LEO call option liability |
|
5,198 |
|
|
4,078 |
|
Operating lease
liabilities |
|
11,853 |
|
|
— |
|
Build-to-suit lease
obligation |
|
— |
|
|
8,000 |
|
Term loans, net |
|
93,392 |
|
|
91,791 |
|
2027 Notes, net |
|
378,502 |
|
|
— |
|
Other liabilities |
|
13,469 |
|
|
3,527 |
|
Redeemable convertible
noncontrolling interests |
|
2,574 |
|
|
2,243 |
|
Total BridgeBio stockholders'
equity |
|
163,756 |
|
|
408,454 |
|
Noncontrolling interests |
|
52,057 |
|
|
65,279 |
|
Total liabilities, redeemable convertible noncontrolling
interests and
stockholders’ equity |
$ 787,693 |
|
$ 631,679 |
|
(1) |
The condensed consolidated balance sheet as of December 31, 2019 is
derived from the audited consolidated financial statements as of
that date. Certain reclassifications have been made to conform to
the September 30, 2020 condensed consolidated balance sheet
presentation. |
(2) |
December 31, 2019 amounts include long-term marketable
securities of $31.1 million. |
|
|
|
|
About BridgeBio Pharma, Inc.
BridgeBio is a team of experienced drug discoverers, developers
and innovators working to discover, create, test and deliver
life-altering medicines that target well-characterized genetic
diseases at their source. BridgeBio was founded in 2015 to identify
and advance transformative medicines to treat patients who suffer
from Mendelian diseases, which are diseases that arise from defects
in a single gene, and cancers with clear genetic drivers.
BridgeBio’s pipeline of over 20 development programs includes
product candidates ranging from early discovery to late-stage
development. For more information,
visit bridgebio.com.
BridgeBio Pharma
Forward-Looking
Statements
This press release contains forward-looking statements.
Statements we make 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,” 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 and are making this statement for
purposes of complying with those safe harbor provisions. These
forward-looking statements, including statements relating to
expectations, plans and prospects regarding the preclinical and
clinical development plans, clinical trial designs, clinical and
therapeutic potential, and strategy of BridgeBio’s product
candidates, our ability to complete, and any effects of, the
proposed merger transaction with Eidos, the unknown future impact
of the COVID-19 pandemic delay on certain clinical trial milestones
and/or BridgeBio’s operations or operating expenses, the number of
potential medicines in our portfolio, our ability to enroll our
trials, the timing and success of our clinical trials, including
our Phase 2 trial of encaleret for ADH1, the success of our
collaboration agreements with each of the Salk Institute and the
University of Colorado Anschutz Medical Campus and our other
collaboration agreements with various academic institutions, the
timing and success of our data readouts in each of acoramidis for
the treatment of ATTR, low-dose infigratinib for the treatment of
achondroplasia, BBP-631 for the treatment of CAH and encalaret for
the treatment of ADH1, the regulatory strategy of fosdenopterin for
the treatment of MoCD Type A, our ability to produce meaningful
medicines, our expected runway for cash, cash equivalents and
marketable securities, and the timing of these events, including
the timing of the completion of our proposed merger with Eidos,
reflect our current views about our plans, intentions,
expectations, strategies and prospects, which are based on the
information currently available to us and on assumptions we have
made. Although we believe that our plans, intentions, expectations,
strategies and prospects 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, the success of clinical
trials, regulatory filings, approvals and/or sales, potential
adverse impacts due to the global COVID-19 pandemic such as delays
in regulatory review, manufacturing and supply chain interruptions,
adverse effects on healthcare systems and disruption of the global
economy, the occurrence of any event, change or other circumstance
that could give rise to the termination of the proposed transaction
with Eidos, the risk that Eidos’ and/or BridgeBio’s stockholders
may not approve the proposed transaction, the inability to complete
the proposed transaction because, among other reasons, conditions
to the closing of the proposed transaction may not be satisfied or
waived, uncertainty as to the timing of completion of the proposed
transaction, potential adverse effects or changes to relationships
with employees, suppliers, strategic partners or other parties
resulting from the announcement or completion of the proposed
transaction, potential litigation relating to the proposed
transaction that could be instituted against Eidos, BridgeBio or
their respective directors and officers, including the effects of
any outcomes related thereto, possible disruptions from the
proposed transaction that could harm Eidos’ or BridgeBio’s
respective business, including current plans and operations,
unexpected costs, charges or expenses resulting from the proposed
transaction, uncertainty of the expected financial performance of
each of Eidos and BridgeBio following completion of the proposed
transaction, including the possibility that the expected synergies
and value creation from the proposed transaction will not be
realized or will not be realized within the expected time period,
and those risks set forth in the Risk Factors section of our most
recent quarterly or annual periodic report filed with the U.S.
Securities and Exchange Commission (SEC) and our other SEC filings.
Moreover, BridgeBio 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 BridgeBio’s management as of the date
of this 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.
Contact:Grace RauhBridgeBio
Pharmagrace.rauh@bridgebio.com 917-232-5478
Source: BridgeBio Pharma, Inc.
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