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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 2, 2024

 

 

BridgeBio Pharma, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-38959	84-1850815
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
3160 Porter Dr., Suite 250
Palo Alto, CA				94304
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 391-9740

 

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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		BBIO		The Nasdaq Global Select Market

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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 2, 2024, BridgeBio Pharma, Inc. reported recent business updates and its financial results for the first quarter ended March 31, 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, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, 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		Press Release dated May 2, 2024, furnished herewith
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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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:	May 2, 2024	By:	/s/ Brian C. Stephenson
			Brian C. Stephenson, Ph.D., CFA Chief Financial Officer

 

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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:

Recent Corporate Updates:

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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

 

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		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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