UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: ( |
Not Applicable |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2024, BridgeBio Pharma, Inc. reported recent business updates and its financial results for the third quarter ended September 30, 2024. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
|
Description |
|
|
|
99.1 |
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
BridgeBio Pharma, Inc. |
|
|
|
|
Date: |
November 12, 2024 |
By: |
/s/ Brian C. Stephenson |
|
|
|
Brian C. Stephenson, Ph.D., CFA |
Exhibit 99.1
BridgeBio Pharma Reports Third Quarter 2024 Financial Results and Business Update
- Patients on acoramidis, a near complete (≥90%) TTR stabilizer in clinical development, lived longer and better as shown in the ATTRibute-CM study. This is the only Phase 3 study of an ATTR-CM disease-modifying treatment to demonstrate improvement in hard clinical outcomes in the combined assessment of CVH and ACM to this degree, this quickly
- BridgeBio’s late-stage pipeline continues to rapidly progress with three Phase 3 readouts expected in 2025. Program highlights from this quarter include:
- CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, completed screening
- FORTIFY, the Phase 3 clinical trial for LGMD2I/R9, completed enrollment
- The FDA granted Breakthrough Therapy Designation to oral infigratinib for achondroplasia
- Regenerative Medicine Advanced Therapy Designation awarded to BBP-812 for Canavan disease
- Published a MIT Business School case study on BridgeBio’s pioneering business model in the 50th edition of the Journal of Portfolio Management celebrating the work of Harry Markowitz, the Nobel prize-winning inventor of Modern Portfolio Theory, outlining our efforts to build a new type of biopharmaceutical company
- The Company ended the quarter with $406 million in cash, cash equivalents, and short-term restricted cash. It anticipates receiving a $500 million milestone payment under our royalty funding agreement upon FDA approval of acoramidis, as well as $105 million in aggregate regulatory milestone payments upon approval of acoramidis in European and Japanese territories
Palo Alto, CA – November 12, 2024 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a new type of biopharmaceutical company focused on genetic diseases, today reported its financial results for the third quarter ended September 30, 2024, and provided an update on the Company’s operations.
“I’m grateful for the continued progress that we have seen across our late-stage pipeline, and I’m excited for the upcoming opportunity to serve patients with ATTR-CM in the commercial marketplace,” said Dr. Neil Kumar, Ph.D., CEO and Founder of BridgeBio. “Underpinning this headway is a corporate experiment we have been conducting for over 9 years now that posits a new type of biotech business model, and so I’m also proud to have released our first case study in The Journal of Portfolio Management, highlighting salient elements of that model.”
Pipeline overview:
Program |
Status |
Next expected milestone |
Acoramidis for ATTR-CM |
NDA filed with U.S. FDA |
November 29, 2024 PDUFA date |
Encaleret for ADH1 |
Enrolling CALIBRATE, Phase 3 study |
Enrollment completion in 2024 |
BBP-418 (ribitol) for LGMD2I/R9 |
FORTIFY, Phase 3 study enrollment completed |
Interim analysis in 2025 |
Infigratinib for achondroplasia |
Enrolling PROPEL 3, Phase 3 study |
Enrollment completion in 2024 |
Infigratinib for hypochondroplasia |
Enrolling observational run-in for ACCEL 2, Phase 2 study |
Enrollment completion date to be announced |
BBP-812 for Canavan disease |
Enrolling at high dose in Phase 1/2 study |
Enrollment completion date to be announced |
1
Late-stage investigational programs updates:
2
3
Third Quarter 2024 Financial Results:
“We are prepared to launch acoramidis in the U.S., upon approval by the FDA, at the end of 2024 as well as to read out our three ongoing Phase 3 studies in 2025,” said Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio. “As we continue to move our late-stage pipeline forward, we are excited to also take an initial step in explaining the thesis and underlying logic of our decision making with the recent release of our case study in The Journal of Portfolio Management.”
Cash, Cash Equivalents, and Short-term Restricted Cash
Cash, cash equivalents and short-term restricted cash, totaled $405.7 million as of September 30, 2024, compared to $392.6 million of cash, cash equivalents and short-term restricted cash as of December 31, 2023. The $13.1 million net increase in cash, cash equivalents and short-term restricted cash was primarily attributable to net proceeds received from the term loan under the credit facility with Blue Owl of $434.0 million, net proceeds received from various equity financings of $314.7 million, proceeds from the sale of investments in equity securities of $63.2 million, and special cash dividends received from investments in equity securities of $25.7 million. These increases in cash, cash equivalents and short-term restricted cash were primarily offset by the impacts of refinancing the Company’s previous senior secured credit term loan, inclusive of prepayment fees and exit-related costs in aggregate of $473.4 million, net cash used in operating activities of $325.4 million, purchases of equity securities of $20.3 million, and repurchase of shares to satisfy tax withholdings of $6.1 million during the nine months ended September 30, 2024.
Revenue
Revenue for the three and nine months ended September 30, 2024 were $2.7 million and $216.0 million, respectively, as compared to $4.1 million and $7.6 million for the same periods in the prior year.
The decrease of $1.4 million in revenue for the three months ended September 30, 2024, compared to the same period in the prior year, was primarily due to the recognition of services revenue under the exclusive license and collaboration agreements with Bayer and Kyowa Kirin. Revenue for the three months ended September 30, 2023 primarily consists of the recognition of services revenue under the Navire-BMS License Agreement, which terminated effective June 2024.
The increase of $208.4 million in revenue for the nine months ended September 30, 2024, compared to the same period in the prior year, was primarily due to $205.3 million from recognition of non-refundable upfront payments and service revenue under the Bayer and the Kyowa Kirin exclusive license and collaboration agreements.
Operating Costs and Expenses
Operating costs and expenses for the three and nine months ended September 30, 2024 were $194.5 million and $583.0 million, respectively, compared to $161.8 million and $437.5 million for the same periods in the prior year.
The overall increase of $32.7 million in operating costs and expenses for the three months ended September 30, 2024, compared to the same period in the prior year, was primarily due to an increase of $33.0
4
million in selling, general and administrative (SG&A) expenses mainly to support commercialization readiness efforts which included costs incurred for marketing, advertising and buildup of salesforce, an increase of $4.3 million in restructuring, impairment and related charges, offset by a decrease of $4.6 million in research and development and other expenses (R&D) mainly due to the deconsolidation of certain subsidiaries.
The overall increase of $145.5 million in operating costs and expenses for the nine months ended September 30, 2024, compared to the same period in the prior year, was primarily due to an increase of $91.1 million in SG&A expenses mainly to support commercialization readiness efforts which included costs incurred for marketing, advertising and buildup of salesforce, an increase of $50.6 million in R&D expenses to advance the Company’s pipeline of research and development programs, and an increase of $3.8 million in restructuring, impairment and related charges. Operating costs and expenses for the nine months ended September 30, 2024, include $25.0 million of nonrecurring deal-related costs for transactions that were completed during the nine months ended September 30, 2024.
Restructuring, impairment and related charges for the three and nine months ended September 30, 2024 amounted to $4.6 million and $10.9 million, respectively. These charges primarily consisted of impairments and write-offs of long-lived assets, severance and employee-related costs, and exit and other related costs. Restructuring, impairment and related charges for the same periods in the prior year were $0.3 million and $7.2 million, respectively. These charges primarily consisted of winding down, exit costs, and severance and employee-related costs.
Stock-based compensation expenses included in operating costs and expenses for the three months ended September 30, 2024 were $27.1 million, of which $12.1 million is included in R&D expenses, $15.0 million is included in SG&A expenses, and less than $0.1 million is included in restructuring, impairment and related charges. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $27.2 million, of which $14.1 million is included in R&D expenses, and $13.1 million is included in SG&A expenses.
Stock-based compensation expenses included in operating costs and expenses for the nine months ended September 30, 2024 were $77.4 million, of which $29.8 million is included in R&D expenses, $47.5 million is included in SG&A expenses, and $0.1 million is included in restructuring, impairment and related charges. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $77.9 million, of which $39.2 million is included in R&D expenses, and $38.7 million is included in SG&A expenses.
Total Other Income (Expense), net
Total other income (expense), net for the three and nine months ended September 30, 2024 were $27.5 million and $91.0 million, respectively, compared to ($21.8) million and ($53.0) million for the same periods in the prior year.
The increase in total other income (expense), net of $49.3 million for the three months ended September 30, 2024, compared to the same period in the prior year, was primarily due to the Company’s gain on deconsolidation of subsidiaries of $52.0 million and an increase in other income (expense), net of $7.1 million mainly due to mark to market fair value adjustments from the Company’s investments in equity securities. This was partially offset by a net loss from an equity method investment of $6.6 million and an increase in interest expense of $2.8 million.
5
The increase in total other income (expense), net of $144.0 million for the nine months ended September 30, 2024, compared to the same period in the prior year, was primarily due to the Company’s gain on deconsolidation of subsidiaries of $178.3 million and an increase in other income (expense), net of $15.1 million mainly due to mark to market fair value adjustments from the Company’s investments in equity securities. These were partially offset by recognition of a loss on extinguishment of debt of $26.6 million, a net loss from equity method investments of $14.5 million and an increase in interest expense of $8.4 million.
Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share
For the three and nine months ended September 30, 2024, the Company recorded a net loss attributable to common stockholders of BridgeBio of $162.0 million and $270.7 million, respectively, compared to $177.0 million and $475.1 million, respectively for the three and nine months ended September 30, 2023.
For the three and nine months ended September 30, 2024, the Company reported a net loss per share of $0.86 and $1.46, respectively compared to $1.08 and $2.99, respectively for the three and nine months ended September 30, 2023.
6
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
(Unaudited) |
|
|
(Unaudited) |
|
||||||||||
Revenue |
|
$ |
2,732 |
|
|
$ |
4,091 |
|
|
$ |
216,020 |
|
|
$ |
7,558 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research, development and other expenses |
|
|
121,042 |
|
|
|
125,734 |
|
|
|
377,905 |
|
|
|
327,333 |
|
Selling, general and administrative |
|
|
68,819 |
|
|
|
35,777 |
|
|
|
194,149 |
|
|
|
103,007 |
|
Restructuring, impairment and related charges |
|
|
4,621 |
|
|
|
272 |
|
|
|
10,912 |
|
|
|
7,172 |
|
Total operating costs and expenses |
|
|
194,482 |
|
|
|
161,783 |
|
|
|
582,966 |
|
|
|
437,512 |
|
Loss from operations |
|
|
(191,750 |
) |
|
|
(157,692 |
) |
|
|
(366,946 |
) |
|
|
(429,954 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
3,296 |
|
|
|
3,793 |
|
|
|
12,566 |
|
|
|
12,460 |
|
Interest expense |
|
|
(23,061 |
) |
|
|
(20,306 |
) |
|
|
(69,469 |
) |
|
|
(61,021 |
) |
Gain on deconsolidation of subsidiaries |
|
|
52,027 |
|
|
|
— |
|
|
|
178,321 |
|
|
|
— |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(26,590 |
) |
|
|
— |
|
Net loss from equity method investments |
|
|
(6,563 |
) |
|
|
— |
|
|
|
(14,488 |
) |
|
|
— |
|
Other income (expense), net |
|
|
1,797 |
|
|
|
(5,283 |
) |
|
|
10,648 |
|
|
|
(4,408 |
) |
Total other income (expense), net |
|
|
27,496 |
|
|
|
(21,796 |
) |
|
|
90,988 |
|
|
|
(52,969 |
) |
Net loss |
|
|
(164,254 |
) |
|
|
(179,488 |
) |
|
|
(275,958 |
) |
|
|
(482,923 |
) |
Net loss attributable to redeemable convertible |
|
|
2,214 |
|
|
|
2,489 |
|
|
|
5,246 |
|
|
|
7,869 |
|
Net loss attributable to common stockholders |
|
$ |
(162,040 |
) |
|
$ |
(176,999 |
) |
|
$ |
(270,712 |
) |
|
$ |
(475,054 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(1.08 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.99 |
) |
Weighted-average shares used in computing net |
|
|
188,510,372 |
|
|
|
163,308,632 |
|
|
|
184,947,173 |
|
|
|
158,891,152 |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
Stock-based Compensation |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
|
|
(Unaudited) |
|
|
(Unaudited) |
|
||||||||||
Research, development and other expenses |
|
$ |
12,124 |
|
|
$ |
14,144 |
|
|
$ |
29,840 |
|
|
$ |
39,152 |
|
Selling, general and administrative |
|
|
14,969 |
|
|
|
13,086 |
|
|
|
47,511 |
|
|
|
38,731 |
|
Restructuring, impairment and related charges |
|
|
38 |
|
|
|
— |
|
|
|
81 |
|
|
|
— |
|
Total stock-based compensation |
|
$ |
27,131 |
|
|
$ |
27,230 |
|
|
$ |
77,432 |
|
|
$ |
77,883 |
|
7
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Assets |
|
(Unaudited) |
|
|
(1) |
|
||
Cash and cash equivalents |
|
$ |
266,324 |
|
|
$ |
375,935 |
|
Investments in equity securities |
|
|
— |
|
|
|
58,949 |
|
Receivables from licensing and collaboration agreements |
|
|
478 |
|
|
|
1,751 |
|
Short-term restricted cash |
|
|
139,409 |
|
|
|
16,653 |
|
Prepaid expenses and other current assets |
|
|
38,367 |
|
|
|
24,305 |
|
Investment in nonconsolidated entities |
|
|
160,443 |
|
|
|
— |
|
Property and equipment, net |
|
|
8,701 |
|
|
|
11,816 |
|
Operating lease right-of-use assets |
|
|
6,439 |
|
|
|
8,027 |
|
Intangible assets, net |
|
|
24,525 |
|
|
|
26,319 |
|
Other assets |
|
|
20,291 |
|
|
|
22,625 |
|
Total assets |
|
$ |
664,977 |
|
|
$ |
546,380 |
|
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
13,363 |
|
|
$ |
10,655 |
|
Accrued and other liabilities |
|
|
109,482 |
|
|
|
122,965 |
|
Operating lease liabilities |
|
|
10,433 |
|
|
|
13,109 |
|
Deferred revenue |
|
|
30,398 |
|
|
|
9,823 |
|
2029 Notes, net |
|
|
738,376 |
|
|
|
736,905 |
|
2027 Notes, net |
|
|
544,719 |
|
|
|
543,379 |
|
Term loan, net |
|
|
436,221 |
|
|
|
446,445 |
|
Other long-term liabilities |
|
|
377 |
|
|
|
5,634 |
|
Redeemable convertible noncontrolling interests |
|
|
645 |
|
|
|
478 |
|
Total BridgeBio stockholders' deficit |
|
|
(1,229,922 |
) |
|
|
(1,354,257 |
) |
Noncontrolling interests |
|
|
10,885 |
|
|
|
11,244 |
|
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit |
|
$ |
664,977 |
|
|
$ |
546,380 |
|
(1) |
The condensed consolidated financial statements as of and for the year ended December 31, 2023 are derived from the audited consolidated financial statements as of that date. |
8
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
(275,958 |
) |
|
$ |
(482,923 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
65,673 |
|
|
|
71,685 |
|
Loss on extinguishment of debt |
|
|
26,590 |
|
|
|
— |
|
Accretion of debt |
|
|
5,399 |
|
|
|
6,724 |
|
Depreciation and amortization |
|
|
4,708 |
|
|
|
4,909 |
|
Noncash lease expense |
|
|
3,119 |
|
|
|
3,024 |
|
Accrual of payment-in-kind interest on term loan |
|
|
— |
|
|
|
6,742 |
|
Net loss from equity method investments |
|
|
14,488 |
|
|
|
— |
|
Loss (gain) on deconsolidation of subsidiaries |
|
|
(178,321 |
) |
|
|
1,241 |
|
Loss (gain) from investment in equity securities, net |
|
|
(8,136 |
) |
|
|
2,951 |
|
Other noncash adjustments, net |
|
|
(2,059 |
) |
|
|
(332 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Receivables from licensing and collaboration agreements |
|
|
1,273 |
|
|
|
11,909 |
|
Prepaid expenses and other current assets |
|
|
(17,543 |
) |
|
|
(980 |
) |
Other assets |
|
|
(428 |
) |
|
|
1,443 |
|
Accounts payable |
|
|
5,257 |
|
|
|
(3,404 |
) |
Accrued compensation and benefits |
|
|
5,580 |
|
|
|
(4,156 |
) |
Accrued research and development liabilities |
|
|
15,454 |
|
|
|
(10,544 |
) |
Operating lease liabilities |
|
|
(4,459 |
) |
|
|
(3,671 |
) |
Deferred revenue |
|
|
20,575 |
|
|
|
(4,464 |
) |
Accrued professional and other liabilities |
|
|
(6,612 |
) |
|
|
(3,055 |
) |
Net cash used in operating activities |
|
|
(325,400 |
) |
|
|
(402,901 |
) |
Investing activities: |
|
|
|
|
|
|
||
Purchases of marketable securities |
|
|
(93,811 |
) |
|
|
(29,726 |
) |
Maturities of marketable securities |
|
|
95,000 |
|
|
|
82,550 |
|
Purchases of investments in equity securities |
|
|
(20,271 |
) |
|
|
(78,314 |
) |
Proceeds from sales of investments in equity securities |
|
|
63,229 |
|
|
|
80,963 |
|
Proceeds from special cash dividends received from investments in equity securities |
|
|
25,682 |
|
|
|
— |
|
Payment for an intangible asset |
|
|
(4,785 |
) |
|
|
— |
|
Purchases of property and equipment |
|
|
(886 |
) |
|
|
(871 |
) |
Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries |
|
|
(140 |
) |
|
|
(503 |
) |
Net cash provided by investing activities |
|
|
64,018 |
|
|
|
54,099 |
|
Financing activities: |
|
|
|
|
|
|
||
Proceeds from term loan under Financing Agreement |
|
|
450,000 |
|
|
|
— |
|
Issuance costs and discounts associated with term loan under Financing Agreement |
|
|
(15,986 |
) |
|
|
— |
|
Repayment of term loan under Loan and Security Agreement |
|
|
(473,417 |
) |
|
|
— |
|
Proceeds from issuance of common stock through public offerings, net |
|
|
314,741 |
|
|
|
450,264 |
|
Proceeds from BridgeBio common stock issuances under ESPP |
|
|
4,502 |
|
|
|
3,397 |
|
Proceeds from stock option exercises, net of repurchases |
|
|
808 |
|
|
|
5,222 |
|
Transactions with noncontrolling interests |
|
|
— |
|
|
|
1,500 |
|
Repurchase of RSU shares to satisfy tax withholding |
|
|
(6,122 |
) |
|
|
(4,325 |
) |
Net cash provided by financing activities |
|
|
274,526 |
|
|
|
456,058 |
|
Net increase in cash, cash equivalents and restricted cash |
|
|
13,144 |
|
|
|
107,256 |
|
Cash, cash equivalents and restricted cash at beginning of period |
|
|
394,732 |
|
|
|
416,884 |
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
407,876 |
|
|
$ |
524,140 |
|
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Supplemental Disclosure of Cash Flow Information: |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
78,236 |
|
|
$ |
50,826 |
|
Supplemental Disclosures of Noncash Investing and Financing Information: |
|
|
|
|
|
|
||
Unpaid public offering issuance costs |
|
$ |
— |
|
|
$ |
455 |
|
Unpaid property and equipment |
|
$ |
274 |
|
|
$ |
192 |
|
Transfers to noncontrolling interests |
|
$ |
(4,719 |
) |
|
$ |
(8,313 |
) |
Reconciliation of Cash, Cash Equivalents and Restricted Cash: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
266,324 |
|
|
$ |
505,213 |
|
Restricted cash |
|
|
139,409 |
|
|
|
16,652 |
|
Restricted cash — Included in “Other assets” |
|
|
2,143 |
|
|
|
2,275 |
|
Total cash, cash equivalents and restricted cash at end of period shown in the |
|
$ |
407,876 |
|
|
$ |
524,140 |
|
9
About BridgeBio Pharma, Inc.
BridgeBio Pharma (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn 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. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to the Company’s clinical trials, including the PDUFA approval date for acoramidis for the treatment of ATTR-CM; timing to share data from the long-term open-label extension of ATTRibute-CM; the potential to receive payments of $500 million and $105 million upon approval of acoramidis; providing U.S. clinical trial patients acoramidis free for life, upon approval; timing for completion of enrollment in PROPEL 3 and completion of the study; timing for sharing top-line results from FORTIFY for the interim analysis population; the potential to pursue Accelerated Approval in the U.S. for ribitol in LGMD2I/R9; the Company’s ability to qualify for a Priority Review Voucher with respect to ribitol; timing for completion of enrollment in CALIBRATE; and the expectation of early and more frequent interactions with the FDA relating to BBP-812 for the treatment of Canavan disease, among others, reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the impacts of current
10
macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Contact:
Vikram Bali
contact@bridgebio.com
(650)-789-8220
11