Bridgebio Pharma, Inc. annual report, FY2020

BridgeBio Pharma, Inc. — 2020 Form 10-K Summary

Business context and reporting period

BridgeBio is a clinical-stage biopharmaceutical company focused on genetically driven diseases and cancers. Its pipeline included more than 30 programs spanning discovery through late-stage development, with more than 18 clinical trials underway across multiple therapeutic areas. The filing covers the fiscal year ended December 31, 2020, and was filed February 25, 2021.

The company had no products approved for commercial sale and generated no product revenue. Reported revenue consisted primarily of licensing and collaboration-related amounts. BridgeBio consolidated several controlled entities, including Eidos Therapeutics, which became wholly owned in January 2021.

Financial performance and key metrics

Metric	2020	2019	Change
License revenue	$8.2 million	$40.6 million	Down $32.3 million
Research and development expense	$337.0 million	$209.9 million	Up $127.1 million
General and administrative expense	$145.7 million	$94.4 million	Up $51.3 million
Loss from operations	$474.5 million	$266.2 million	Higher loss by $208.2 million
Net loss	$505.5 million	$288.6 million	Higher loss by $216.9 million
Net loss attributable to BridgeBio common stockholders	$448.7 million	$260.6 million	Higher loss by $188.1 million
Basic and diluted loss per share	$3.80	$2.48	Higher loss per share
Net cash used in operating activities	$399.7 million	$253.6 million	Higher use by $146.1 million
Cash, cash equivalents and marketable securities	$607.1 million	$577.1 million	Up $30.0 million

Research and development spending increased primarily because of higher external development, manufacturing-validation and personnel costs. Program-level 2020 R&D spending included approximately $90.0 million for infigratinib, $76.7 million for acoramidis, $22.8 million for fosdenopterin, $21.3 million for BBP-631 and $13.4 million for BBP-418.

Interest expense increased to $36.7 million from $8.8 million, primarily following the issuance of the 2027 convertible notes and higher debt balances. Stock-based compensation increased to $58.5 million from $21.4 million.

At December 31, 2020, total assets were $703.6 million, total liabilities were $595.7 million, and total stockholders’ equity was $106.3 million. The accumulated deficit was $888.8 million. The filing does not provide a meaningful operating or net margin because the company had minimal licensing revenue, no product sales and substantial development expenses.

Liquidity, debt and contractual commitments

Cash, cash equivalents and marketable securities totaled $607.1 million at year-end, including $356.1 million of cash and cash equivalents and $251.0 million of short-term marketable securities.
Management stated that available cash, cash equivalents and marketable securities were expected to fund operations for at least the next 12 months based on current plans.
Consolidated indebtedness was reported at $642.5 million on a gross basis, including $550.0 million of 2.50% convertible senior notes due 2027, $75.0 million of Hercules term loans and $17.5 million of Eidos term debt. The balance-sheet carrying amount of debt was lower because of discounts and issuance costs.
The 2027 notes had a net carrying amount of $383.4 million and an initial conversion price of approximately $42.71 per share. The notes were convertible into cash, stock or a combination at BridgeBio’s election.
Contractual obligations totaled $788.8 million, including principal and interest on the 2027 notes, term loans, leases and a manufacturing agreement. Potential license, royalty and milestone payments were excluded because their timing or achievement was not considered probable or estimable.
The company did not draw the additional $25.0 million Hercules tranche available through December 15, 2020 and had not drawn the remaining additional facilities as of year-end.

Material changes versus the prior comparable period

License revenue declined 80% because 2019 included substantial upfront amounts from the Eidos-Alexion and QED-LianBio agreements, while 2020 primarily reflected recognition of an $8.0 million Navire-LianBio upfront payment.
R&D expense increased 61%, reflecting advancement of late-stage programs, manufacturing validation and workforce growth.
G&A expense increased 54%, including costs associated with organizational expansion and commercial launch-readiness activities.
Operating cash burn increased 58% to $399.7 million.
BridgeBio issued $550.0 million of 2027 convertible senior notes and used approximately $75.0 million to repurchase 2.4 million common shares and $49.3 million for capped-call transactions.
The company adopted the new lease accounting standard, recognizing operating lease right-of-use assets and liabilities.
BridgeBio ceased to qualify as an emerging growth company and became a large accelerated filer, resulting in additional reporting and auditor-attestation requirements.

Pipeline, outlook and management commentary

Acoramidis: The Phase 3 ATTRibute-CM trial enrolled 632 patients. Management expected 12-month six-minute walking-distance data from Part A in late 2021 or early 2022 and anticipated an NDA submission in 2022 if the endpoint was strongly positive.
Infigratinib: The company was enrolling pediatric achondroplasia studies and expected initial PROPEL 2 data in the second half of 2021. It also filed an NDA for previously treated cholangiocarcinoma; the application received Priority Review and was included in the FDA’s Real-Time Oncology Review pilot.
BBP-631: The company anticipated starting a Phase 1/2 trial for congenital adrenal hyperplasia in the second half of 2021, with initial data expected in late 2021 or early 2022.
Encaleret: An ongoing Phase 2b study in autosomal dominant hypocalcemia was expected to produce early results in the first half of 2021.
Other programs: Fosdenopterin had an NDA under Priority Review for MoCD Type A. Patidegib, BBP-589 and BBP-681 were in clinical development, while multiple oncology, gene-therapy and rare-disease programs remained preclinical or early stage.
Management expected continued significant operating losses and substantial R&D spending for the foreseeable future. No profitability timeline or product-sales guidance was provided.

Risks, contingencies and unusual items

COVID-19 caused or could cause clinical enrollment delays, site disruptions, supply-chain constraints, manufacturing delays and slower regulatory inspections.
All programs remained subject to substantial clinical, regulatory, manufacturing, intellectual-property and commercial risks. Early-stage or interim data may not predict later-stage outcomes.
The company relied on third-party CROs and CMOs, including single-source suppliers for certain materials, and did not own manufacturing facilities.
BridgeBio expected to require substantial additional financing. Future financing could dilute shareholders, increase debt obligations or require unfavorable licensing or collaboration terms.
The Hercules facility is secured by substantially all of BridgeBio’s assets and includes operating restrictions, mandatory prepayment provisions and other covenants. Eidos debt was also secured by substantially all of Eidos’ assets other than intellectual property.
The company disclosed potential performance-based milestone compensation of up to $267.4 million, of which $10.6 million had been accrued as probable at year-end.
The Eidos merger closed January 26, 2021. Consideration included approximately $21.3 million of cash and 26.1 million BridgeBio shares; total estimated merger transaction costs reached $78.2 million.
After year-end, BridgeBio issued $717.5 million of 2.25% convertible senior notes due 2029, received approximately $731.7 million of net proceeds, spent approximately $61.3 million on capped calls and $50.0 million on share repurchases.
No material legal proceedings were pending as of the filing date, although the filing identifies potential litigation and integration risks related to the Eidos transaction.

Most important facts for investors to verify

Whether acoramidis Phase 3 results support regulatory approval and the anticipated NDA timing.
FDA decisions and labeling for infigratinib and fosdenopterin, including any confirmatory-trial or manufacturing requirements.
Actual cash burn, remaining liquidity and the duration of available funding after the Eidos merger and 2029 notes issuance.
Total consolidated debt, required repayments, conversion exposure and compliance with Hercules and subsidiary loan covenants.
Clinical-trial enrollment, COVID-19 effects, manufacturing capacity and reliance on single-source suppliers.
Potential dilution from the 2027 and 2029 convertible notes, stock compensation, merger consideration and future financings.
Achievement and settlement of contingent milestone compensation, licensing milestones, royalties and other obligations excluded from the contractual-obligations table.
Integration costs, operating results and expected synergies following Eidos becoming a wholly owned subsidiary.