EX-99.1 2 bbio-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

BridgeBio Pharma Reports First Quarter 2024 Financial Results and Business Update

- Presented cardiac magnetic resonance (CMR) imaging evidence consistent with clinical improvement observed in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in the ATTRibute-CM Phase 3 study of acoramidis at the American College of Cardiology Annual Scientific Sessions; additional detailed results from ATTRibute-CM are planned for presentation at 2024 medical meetings, including four abstracts accepted for the European Society of Cardiology Heart Failure conference and eleven abstracts accepted for the International Symposium on Amyloidosis in May 2024

- The Company believes there is potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA on the use of glycosylated alpha dystroglycan (αDG) levels as a surrogate endpoint; the FORTIFY Phase 3 trial of BBP-418 in limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) continues to enroll, with full enrollment of the interim analysis population expected in 2024

 

- BridgeBio secured up to $1.5 billion in a Q1 2024 capital campaign that included a European licensing agreement for acoramidis in ATTR-CM, a Japanese licensing agreement for infigratinib in skeletal dysplasias, a financing in exchange for a 5% royalty on future acoramidis net sales, a credit facility refinancing existing senior secured credit, and primary stock sales

- 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 Company’s Marketing Authorization Application (MAA) for acoramidis was accepted by review for the European Medicines Agency (EMA), with an expected approval in 2025; this is in addition to the November 29, 2024 PDUFA date set by the U.S. Food and Drug Administration (FDA) for the company’s New Drug Application (NDA) for acoramidis for the treatment of ATTR-CM

 

- The Company ended the quarter with $520 million in cash, cash equivalents, marketable securities and short-term restricted cash

 

Palo Alto, CA – May 2, 2024 – 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.”

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BridgeBio’s late stage programs:

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):
o
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.
o
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.
o
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.
o
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:
o
The PROPEL 3 global Phase 3 registrational study of infigratinib in achondroplasia continues to enroll; study completion continues to be anticipated for 2025.
o
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):
o
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.
o
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):
o
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:

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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

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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 US 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.

 

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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

 

 

 

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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.

 

 

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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

 

 

7


 

 

 

 

 

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

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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

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