On February 23, 2023 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results for the fourth quarter and the full year ending December 2022 (Press release, Dynavax Technologies, FEB 23, 2023, View Source [SID1234627602]).

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"In 2022, our team exceeded our strategic goals, achieving record HEPLISAV-B revenue, advancing our clinical pipeline and delivering orders of CpG 1018 adjuvant for the equivalent of hundreds of millions of COVID-19 vaccine doses," said Ryan Spencer, Chief Executive Officer of Dynavax. "Following a year of successful execution on our strategy, we are excited for 2023 and look forward to continuing our trend of significant and sustainable annual HEPLISAV-B revenue growth and overall advancement of our business focused on protecting patients worldwide from infectious diseases."

2023 FINANCIAL GUIDANCE

Dynavax anticipates full-year 2023 revenue and operating expenses to be in the ranges below:

HEPLISAV-B net product revenue between approximately $165 – $185 million
Research and development expenses between approximately $55 – $70 million
Selling, general and administrative expenses between approximately $135 – $155 million
BUSINESS UPDATES

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S. and EU that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

HEPLISAV-B vaccine achieved record annual net product revenue of $125.9 million for 2022, compared to $61.9 million for 2021, representing annual growth of 104%.
HEPLISAV-B market share in prioritized Integrated Delivery Networks (IDNs) and Clinics increased to approximately 47%, with total market share increasing to approximately 35%, up from approximately 33% and 25%, respectively, at the end of 2021.
Dynavax believes it has begun to see a positive impact on HEPLISAV-B revenue from the expanded ACIP recommendation for adult hepatitis B vaccination which has the potential to expand the market to over $800 million by 2027 with HEPLISAV-B well-positioned to achieve a majority market-share.
CpG 1018 Adjuvant Supply for COVID-19 Vaccines
Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements (CSAs) supporting the development of COVID-19 vaccines across a variety of vaccine platforms.

CpG 1018 adjuvant achieved annual net product revenue of $587.7 million for 2022, up 57% compared to $375.2 million for 2021.
Due to the successful execution on the pandemic commercial supply agreements and the resulting volume of partners’ overall stockpile, coupled with unknowns about the trajectory of the COVID-19 pandemic, Dynavax believes it will have minimal to as little as zero CpG 1018 adjuvant net product revenues in 2023.
Clinical Pipeline
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Tetanus, diphtheria and pertussis (Tdap) vaccine program:

In October, the Company presented adult and adolescent safety data from a Phase 1 clinical trial demonstrating the Tdap vaccine candidate was well tolerated without observed safety concerns. Immunogenicity in adults was consistent with the Company’s expectations and support its plan to continue advancement of this clinical program. These clinical results were presented at ID Week 2022.
Data from non-human primate challenge study is anticipated mid-2023.
The Company plans to initiate a human challenge study by the end of 2023.
Shingles vaccine program:

In January 2023, the Company reported top line results from the Phase 1 clinical trial designed to evaluate an investigational shingles vaccine, utilizing different regimens of CpG 1018 adjuvant.
The full Phase 1 data will be submitted for presentation at an upcoming medical meeting in the first half of 2023.
The Company plans to initiate a Phase 1/2 study in early 2024 to evaluate various dose levels of glycoprotein E (gE).
Plague vaccine candidate funded by the Defense Department (DoD):

Part 1 of the Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability in adults of a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 was successfully completed in January 2023.
Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint and demonstrated a greater than two-fold increase in antibodies over the alum adjuvanted control arm after two doses.
The DoD has approved continuing to Part 2 using a bedside mix of CpG 1018 with the alum adjuvanted rF1V plague vaccine.
FOURTH QUARTER AND FULL YEAR FINANCIAL HIGHLIGHTS

Total Revenue.

Total revenue for the fourth quarter of 2022 was $184.5 million, compared to $195.1 million for the fourth quarter of 2021.
Total revenue for the full year 2022 was $722.7 million, compared to $439.4 million for the full year 2021.
Product Revenue, Net.
HEPLISAV-B

HEPLISAV-B vaccine product revenue, net was $34.9 million for the fourth quarter of 2022, compared to $17.2 million for the fourth quarter of 2021.
HEPLISAV-B vaccine product revenue, net was $125.9 million for the full year 2022, compared to $61.9 million for the full year 2021, representing annual growth of 104%.
CpG 1018 Adjuvant Supply for COVID-19 Vaccines

CpG 1018 adjuvant product revenue, net was $147.2 million in the fourth quarter of 2022, compared to $177.4 million in the fourth quarter of 2021.
CpG 1018 adjuvant product revenue, net was $587.7 million for the full year 2022, compared to $375.2 million for the full year 2021.
Cost of Sales – Product. Cost of sales – product for the fourth quarter of 2022 increased to $77.5 million, compared to $74.0 million for the fourth quarter of 2021. Full year 2022 cost of sales – product was $262.2 million compared to $173.6 million for the full year 2021. The increase was due to higher sales volume for HEPLISAV-B and CpG 1018 adjuvant in 2022.

Research and Development Expenses (R&D). R&D expenses for the fourth quarter of 2022 increased to $12.9 million, compared to $11.1 million for the fourth quarter of 2021. Full year 2022 R&D expenses were $46.6 million compared to $32.2 million for the full year 2021. The increase was primarily driven by continued investments in our product candidates utilizing CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the fourth quarter of 2022 increased to $31.0 million, compared to $29.2 million for the fourth quarter of 2021. Full year 2022 SG&A expenses were $131.4 million compared to $100.2 million for the full year 2021. The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts to increase market share and maximize the Centers for Disease Control and Prevention’s Advisory Committee of Immunization Practices (ACIP) universal recommendation.

Net Income. GAAP net income was $67.7 million, or $0.53 per share (basic) and $0.45 per share (diluted) in the fourth quarter of 2022, compared to GAAP net income of $99.8 million, or $0.80 per share (basic) and $0.55 per share (diluted) in the fourth quarter of 2021. GAAP net income was $293.2 million, or $2.32 per share (basic) and $1.97 per share (diluted) for the full year 2022, compared to GAAP net income was $76.7 million, or $0.62 per share (basic) and $0.57 per share (diluted) for the full year 2021.

Cash and Marketable Securities. Cash and marketable securities were $624.4 million as of December 31, 2022.

Conference Call and Webcast Information

Dynavax will host a conference call and live audio webcast on Thursday, February 23, 2023, at 4:30 p.m. (ET)/1:30 p.m. (PT). The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).

On February 23, 2023 CTI BioPharma Corp. (Nasdaq: CTIC), a commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers, reported that its fourth quarter and full year 2022 financial results will be reported on Monday, March 6, 2023, after the close of the financial markets (Press release, CTI BioPharma, FEB 23, 2023, View Source [SID1234627601]). Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

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Registration for the live and archived webcast may be accessed on the CTI BioPharma website under the Investors & Media section: Events and Presentations. To participate via telephone, please register in advance using the link provided in the event listing. The Company suggests participants log in 15 minutes in advance of the event.

On February 23, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported business highlights and financial results for the year ended December 31, 2022 (Press release, C4 Therapeutics, FEB 23, 2023, View Source [SID1234627600]).

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"2022 was a year of execution that has laid the groundwork for 2023 as we work to progress three clinical programs, with a fourth expected to enter the clinic by year end," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "With cash runway through the end of 2024, we look forward to having two clinical readouts in the second half of the year, which have the potential to validate our TORPEDO platform to develop both BiDAC and MonoDAC degraders for patients with difficult-to-treat diseases."

FOURTH QUARTER 2022 AND RECENT HIGHLIGHTS

CFT7455: CFT7455 is an oral degrader of IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL).

Progressed the Phase 1/2 Clinical Trial: In January 2023, opened Arm B2 of the ongoing Phase 1/2 clinical trial, evaluating CFT7455 in combination with dexamethasone for the treatment of MM.
CFT8634: CFT8634 is an oral degrader of BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Encouraging Initial Pharmacokinetic (PK) and Pharmacodynamic (PD) Data: In January 2023, shared PK and PD data from the initial escalation cohorts of the ongoing CFT8634 Phase 1/2 clinical trial demonstrating dose proportional exposure, strong oral bioavailability and deep BRD9 degradation.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600 mutations for the treatment of solid tumors including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and melanoma.

Dosed First Patient in Phase 1/2 Clinical Trial: In January 2023, dosed the first patient in the CFT1946 Phase 1/2 clinical trial. Trial sites are open and enrolling patients with BRAF V600 mutant cancers including NSCLC, CRC and melanoma.
New Preclinical Data Accepted for Presentation at AACR (Free AACR Whitepaper): Accepted to present new preclinical data on the discovery and characterization of CFT1946 at 2023 AACR (Free AACR Whitepaper) Annual Meeting.
KEY UPCOMING MILESTONES

CFT7455: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial of Arm B1, evaluating CFT7455 as a monotherapy in MM, in the second half of 2023.
CFT8634: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial in the second half of 2023 in synovial sarcoma and SMARCB1-null solid tumors.
CFT1946: Continue site activation and patient enrollment of the dose escalation portion of the CFT1946 Phase 1/2 clinical trial in BRAF V600 mutant solid tumors. Present new preclinical data on the discovery and characterization of CFT1946 at 2023 AACR (Free AACR Whitepaper) Annual Meeting in April.
CFT8919: Submit an Investigational New Drug (IND) application for CFT8919 for the treatment of NSCLC in the first half of 2023.
UPCOMING INVESTOR EVENTS

March 6, 2023: Management will participate in the Cowen & Co. 43rd Annual Health Care Conference.
FULL YEAR 2022 FINANCIAL RESULTS

Revenue: Total revenue for the year ended December 31, 2022 was $31.1 million, compared to $45.8 million for the year ended December 31, 2021. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico. The decrease in revenue is primarily due to a one-time cumulative recognition during the year ended December 31, 2021 for all of the previously unrecognized revenue allocated to the BRAF program upon the termination of the Roche agreement related to that target.

Research and Development (R&D) Expense: R&D expense for the year ended December 31, 2022 was $117.8 million, compared to $94.7 million for the year ended December 31, 2021. The increase in R&D expense was primarily attributable to clinical costs for CFT7455 and CFT8634, increased external costs, and internal workforce expenses to support the increased level of clinical trial activity.

General and Administrative (G&A) Expense: G&A expense for the year ended December 31, 2022 was $42.8 million, compared to $33.3 million for the year ended December 31, 2021. The increase in G&A expense was primarily attributable to the full-year 2022 impact of the build-out of our general and administrative team to support business growth.

Net Loss and Net Loss per Share: Net loss for the year ended December 31, 2022 was $128.2 million, compared to $83.9 million for the year ended December 31, 2021. Net loss per share for the year ended December 31, 2022 was $2.62, compared to $1.82 for the year ended December 31, 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2022 was $337.1 million, compared to $451.5 million as of December 31, 2021. C4T expects that its cash, cash equivalents and marketable securities as of December 31, 2022, together with anticipated collaboration expense reimbursements, but excluding any collaboration option or milestone payments, will enable the company to fund its operating plan to the end of 2024.

On February 23, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported its financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on the Company’s operations (Press release, BridgeBio, FEB 23, 2023, View Source [SID1234627599]).

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"We are excited to enter 2023 back on the doorstep of potentially meaningful advances for the patients we serve," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "Amidst our six ongoing Phase 2 or 3 clinical trials, we anticipate important upcoming readouts from our achondroplasia Phase 2 trial in March, and our ATTR-CM Phase 3 trial mid-year."

BridgeBio’s key programs:

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):
The Phase 3 ATTRibute-CM study continues to have high operating fidelity.
The Company expects to announce topline registrational data for the month 30 primary endpoint, a hierarchical composite including all-cause mortality and cardiovascular-related hospitalizations, in mid-2023.

Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:
In July 2022, we reported initial data from the fourth dosing cohort of the Phase 2 dose-escalation trial PROPEL 2, demonstrating a mean change from baseline in annualized height velocity (AHV) of +1.52 cm/year and a responder rate of 64% in children five years of age and older.
Through the fifth dosing cohort to date, infigratinib has been well-tolerated with no serious adverse events reported, no adverse events that required discontinuation reported, and with no dose-dependent phosphate elevation reported.
The Company expects to share preliminary data from the fifth dosing cohort in March 2023, and to initiate a registrational Phase 3 trial in 2023.
In Cohort 5, the Company hopes to observe a tolerability profile and efficacy at least in-line with Cohort 4. If successful, the Company believes infigratinib, if approved, has the potential to capture a significant share of the market based on blinded market research.

Encaleret – Calcium-sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1):
In December 2022, the Company initiated the CALIBRATE Phase 3 trial, a pivotal trial comparing the effects of encaleret to standard of care on blood calcium concentration and 24-hour urine calcium excretion over a 24-week treatment period in patients with ADH1.
In a Phase 2b safety and efficacy trial of encaleret for ADH1, 69% of the participants achieved concurrent values of both blood calcium concentration and 24-hour urine calcium excretion within the reference range after 24 weeks of outpatient encaleret treatment; none of these individuals attained this dual therapeutic goal while on standard of care.
Population genetics analyses estimate approximately 25,000 carriers of gain-of-function variants of the CaSR, the underlying cause of ADH1, in the US and EU.
The Company anticipates sharing topline data from CALIBRATE in late 2023 or the first half of 2024.
If approved, encaleret could be the first therapy specifically indicated for the treatment of ADH1.

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2i (LGMD2I):
The Company reported positive top line data from the ongoing Phase 2 clinical trial in October 2022 and anticipates initiating a global Phase 3 registrational trial of BBP-418 for LGMD2I in 2023.
To that end, the Company has engaged with regulatory authorities to align on a Phase 3 trial design.
BBP-418 has a potentially-addressable population of 7,000 LGMD2I patients in the US and EU.
There are currently no disease-modifying treatments available for LGMD2I.

BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH):
The Phase 1/2 gene therapy trial of BBP-631 for CAH continued to progress; as of February 1, 2023, BBP-631 has been generally well-tolerated in four patients treated at the first two dose levels.
The Company plans to provide an update from patients treated at the third dose level by the end of 2023.
CAH is one of the most prevalent genetic diseases potentially addressable with adeno-associated virus (AAV) gene therapy, with more than 75,000 cases estimated in the United States and European Union.

RAS cancer portfolio:
BridgeBio is continuing to progress the three main programs of its RAS franchise:
BBO-8520, an investigational, next-generation small molecule KRAS G12C dual inhibitor candidate that is designed to directly bind and inhibit KRAS G12C in both its active (GTP bound) and inactive (GDP bound) conformations, which remains on track to file an IND and enter the clinic in the second half of 2023.
A PI3Kα:RAS breaker program, investigational small molecules that are designed to block Ras-driven PI3Kα activation with a novel and potentially broad mechanism of action to target not only PI3Kα mutant tumors and RAS mutant tumors, but potentially other tumors driven by RTK activation of RAS signaling. The Company remains on track to select a development candidate in 2023, with IND filing to follow in 2024.
The Company’s pan-KRAS program, which targets multiple KRAS mutants including KRASG12D and KRASG12V, which are present in a large percentage of colorectal, pancreatic, and non-small cell lung cancer tumors. Development candidate selection for this program is planned for late 2023 or early 2024.
Corporate Updates:

Board of Directors: Appointed Frank McCormick, Ph.D., FS, DSc (Hon) to the BridgeBio Board of Directors. Dr. McCormick is a co-founder of BridgeBio and serves as the Chairman of Oncology. He is also a professor at the UCSF Helen Diller Family Comprehensive Cancer Center, where he holds the David A. Wood Chair of Tumor Biology and Cancer Research, and he has led the National Cancer Institute’s Ras Initiative since its inception in 2013. Dr. McCormick rotates in as Dr. Richard Scheller leaves the Board of Directors; Dr. Scheller will continue to serve as BridgeBio’s Chairman of Research and Development. In addition, Brent Saunders will resign from the board of directors in early March in order to focus on his recent appointment as Chief Executive Officer and Chairman of the Board of Bausch + Lomb.
Fourth Quarter and Full Year 2022 Financial Results:
Cash, Cash Equivalents, Marketable Securities and Restricted Cash (Current)

Cash, cash equivalents, marketable securities and restricted cash (current), totaled $466.2 million as of December 31, 2022, compared to $787.7 million as of December 31, 2021. The net decrease of $321.5 million in cash, cash equivalents, marketable securities and restricted cash (current) is primarily attributable to net cash used in operating activities of $419.5 million. Net cash used in operating activities during the fiscal year 2022 was partially offset by a $90.0 million upfront payment received under the License, Development and Commercialization Agreement by and among the Company, its affiliate, Navire Pharma, Inc., and Bristol-Myers Squibb Company, or BMS (the "Navire-BMS License Agreement").

During fiscal year 2022, the Company also received $110.0 million from the sale of its priority review voucher, $10.0 million upon closing of an asset purchase agreement between its affiliate, Origin Biosciences, Inc., and Sentynl Therapeutics, Inc. and $4.9 million of net proceeds from the sale of common stock through an "at-the-market" offering. The Company made a $20.5 million mandatory prepayment of a portion of its term loan obligations under its Loan and Security Agreement, as amended, in connection with the upfront payment received from BMS.

As of December 31, 2022, the Company’s restricted cash (current) balance of $37.9 million primarily represents funds in a controlled account that was established in connection with the Second Amendment of the Company’s Amended Loan and Security Agreement. The use of such non-interest-bearing cash is restricted per the terms of the underlying amended loan agreement and is to be used solely for certain research and development expenses directly attributable to the performance of obligations associated with the Navire-BMS License Agreement.

Cash, cash equivalents, marketable securities and restricted cash (current), decreased by $92.3 million when compared to the balance as of September 30, 2022 of $558.5 million. Net cash used in operating activities was $93.2 million for the three months ended December 31, 2022 which primarily contributed to the decline in the cash, cash equivalents, marketable securities and restricted cash (current) during the fourth quarter of fiscal year 2022.

Operating Costs and Expenses
Operating costs and expenses for the three months and year ended December 31, 2022 were $131.1 million and $589.9 million, respectively, as compared to $178.5 million and $646.3 million for the same periods in the prior year. The overall decrease in operating costs and expenses for the three months and year ended December 31, 2022 compared to the comparative periods was mainly due to overall decreases in research, development and other (R&D) expenses and selling, general and administrative expenses resulting from the Company’s reprioritization of its R&D programs and company-wide streamlining of costs. The effects of the Company’s restructuring initiative that began in the first quarter of fiscal year 2022 are now being realized due to reductions of operating costs and expenses. Restructuring, impairment and related charges for the three months and year ended December 31, 2022 of $7.7 million and $43.8 million, respectively, were primarily comprised of winding down costs, exit and other related costs, impairments and write-offs of long-lived assets, and severance and employee-related costs. The Company continues to evaluate its restructuring alternatives to drive operational changes in business processes, efficiencies, and cost savings.

"We head into 2023 with cash on hand providing us with runway into 2024, and as we read out our key upcoming catalysts we expect to continue to allocate our capital carefully in order to preserve that runway and our optionality," said Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio. "We will also continue to look for ways to extend our runway by considering potential royalty monetizations and partnerships."

The Company’s research and development and other expenses have not been significantly impacted by the global COVID-19 pandemic for the periods presented. While BridgeBio experienced some delays in certain of its clinical enrollment and trial commencement activities, it continues to adapt with alternative site, telehealth and home visits, and at-home drug delivery, as well as mitigation strategies with its contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on BridgeBio’s operating costs and expenses is currently unknown.

BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)

Three Months Ended December 31, Year Ended December 31,

2022 2021 2022 2021
(Unaudited) (Unaudited) (1)
Revenue $ 1,870 $ 12,886 $ 77,648 $ 69,716
Operating costs and expenses:
Research, development and others 91,549 123,751 402,896 454,138
Selling, general and administrative 31,862 54,749 143,189 192,210
Restructuring, impairment and related charges 7,691 — 43,765 —
Total operating costs and expenses 131,102 178,500 589,850 646,348
Loss from operations (129,232 ) (165,614 ) (512,202 ) (576,632 )
Other income (expense), net:
Interest income 4,092 182 7,542 1,133
Interest expense (19,990 ) (15,134 ) (80,438 ) (46,778 )
Gain from sale of priority review voucher, net — — 107,946 —
Other income (expense), net 4,560 28,284 (7,500 ) 35,823
Total other income (expense), net (11,338 ) 13,332 27,550 (9,822 )
Net loss (140,570 ) (152,282 ) (484,652 ) (586,454 )
Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests 2,979 5,105 3,469 23,915
Net loss attributable to common stockholders of BridgeBio $ (137,591 ) $ (147,177 ) $ (481,183 ) $ (562,539 )
Net loss per share, basic and diluted $ (0.92 ) $ (1.01 ) $ (3.26 ) $ (3.90 )
Weighted-average shares used in computing net loss per share, basic and diluted 149,344,380 145,283,213 147,473,076 144,356,619


Three Months Ended December 31, Year Ended December 31,

Stock-based compensation 2022 2021 2022 2021
(Unaudited) (Unaudited) (1)
Research, development and others $ 8,941 $ 9,654 $ 37,987 $ 56,195
Selling, general and administrative 13,643 12,859 54,669 49,379
Restructuring, impairment and related charges — — 1,172 —
Total stock-based compensation $ 22,584 $ 22,513 93,828 $ 105,574
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2021 are derived from the audited consolidated financial statements as of that date.

BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)

December 31 December 31,

2022 2021
(Unaudited) (1)
Assets
Cash and cash equivalents and marketable securities $ 428,269 $ 787,515
Investment in equity securities 43,653 49,148
Receivable from licensing and collaboration agreements 17,079 19,749
Restricted cash, current 37,930 177
Prepaid expenses and other current assets 21,922 32,269
Property and equipment, net 14,569 30,066
Operating lease right-of-use assets 10,678 15,907
Intangible assets, net 28,712 44,934
Other assets 20,224 33,027
Total assets $ 623,036 $ 1,012,792
Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit
Accounts payable $ 11,558 $ 11,884
Accrued and other liabilities 106,195 118,247
Operating lease liabilities 15,949 22,366
2029 Notes 734,988 733,119
2027 Notes 541,634 539,934
Term loan 430,993 430,752
Other long-term liabilities 26,643 22,069
Redeemable convertible noncontrolling interests (1,589 ) 1,423
Total BridgeBio stockholders’ deficit (1,254,617 ) (870,414 )
Noncontrolling interests 11,282 3,412
Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit $ 623,036 $ 1,012,792
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2021 are derived from the audited consolidated financial statements as of that date.

BRIDGEBIO PHARMA, INC.
Consolidated Statements of Cash Flows
(In thousands)

Year Ended December 31,

2022 2021
Unaudited (1)
Operating activities
Net loss $ (484,652 ) $ (586,454 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 91,559 99,505
Depreciation and amortization 6,771 5,843
Noncash lease expense 5,172 5,611
Net loss (gain) from investment in equity securities 8,222 (29,914 )
Gain from sale of priority review voucher, excluding transaction costs (110,000 ) —
Accrual of payment-in-kind interest on term loan 13,562 —
Gain from recognition of receivable from licensing and collaboration agreement (12,500 ) —
Fair value of shares issued under a license agreement 4,567 —
Accretion of debt 8,570 5,795
Fair value adjustment of warrants 1,571 1,197
Loss on sale of certain assets 6,261 —
Impairment of long-lived assets 12,720 —
LEO call option expense (income) — (5,550 )
Loss on early extinguishment of debt — 3,337
Other noncash adjustments 604 7,092
Changes in operating assets and liabilities: —
Receivable from licensing and collaboration agreements 15,169 (19,749 )
Prepaid expenses and other current assets 7,671 (4,262 )
Other assets 10,971 (9,816 )
Accounts payable (349 ) 2,833
Accrued compensation and benefits (2,362 ) 7,378
Accrued research and development liabilities (4,309 ) 11,178
Accrued professional services (4,996 ) 2,157
Operating lease liabilities (6,245 ) (6,122 )
Deferred revenue 15,262 —
Other accrued and other long-term liabilities (2,733 ) 12,007
Net cash used in operating activities (419,494 ) (497,934 )
Investing activities
Purchases of marketable securities (137,493 ) (589,892 )
Maturities of marketable securities 479,688 380,200
Sales of marketable securities — 62,691
Purchases of investment in equity securities (55,562 ) (53,383 )
Sales of investment in equity securities 52,835 34,150
Increase in cash and cash equivalents from consolidation of PellePharm — 13,654
Payment for intangible assets (1,500 ) (35,000 )
Proceeds from sale of priority review voucher, excluding transaction costs 110,000 —
Proceeds from sale of certain assets 10,000 —
Purchases of property and equipment (4,821 ) (13,246 )
Net cash provided by (used in) investing activities 453,147 (200,826 )
Financing activities
Proceeds from issuance of 2029 Notes — 747,500
Issuance costs and discounts associated with issuance of 2029 Notes — (16,064 )
Purchase of capped calls — (61,295 )
Repurchase of common stock — (200,000 )
Proceeds from issuance of noncontrolling interests — 3,500
Repurchase of Eidos noncontrolling interest, including direct transaction costs — (85,090 )
Proceeds from term loan, net of issuance costs — 456,296
Repayment of term loan (20,486 ) (124,119 )
Proceeds from common stock issuances under ESPP 2,558 3,821
Repurchase of common stock to satisfy tax withholding (1,561 ) (4,746 )
Proceeds from stock option exercises, net of repurchases 666 16,643
Proceeds from issuance of common stock through at-the-market offering, net 4,852 —
Other financing activities 837 —
Net cash (used in) provided by financing activities (13,134 ) 736,446
Net increase in cash, cash equivalents and restricted cash 20,519 37,686
Cash, cash equivalents and restricted cash at beginning of year 396,365 358,679
Cash, cash equivalents and restricted cash at end of year $ 416,884 $ 396,365

Year Ended December 31,

2022 2021
Unaudited (1)
Supplemental Disclosures of Cash Flow Information:
Cash paid for interest $ 54,443 $ 29,774
Supplemental Disclosures of Non-Cash Investing and Financing Information:
Payment-in-kind interest accrued in prior year added to principal of term loan $ 1,763 $ —
Leasehold improvements paid by landlord $ — $ 2,449
Transfers to noncontrolling interests $ (3,512 ) $ (2,124 )
Noncash contribution by a noncontrolling interest $ — $ 21,600
Unpaid property and equipment $ 47 $ 563
Recognized intangible asset recorded in other accrued and other long-term liabilities $ 11,000 $ 12,500
Unpaid debt issuance costs $ — $ 1,120
Net noncash portion of repurchase of Eidos noncontrolling interests $ — $ 38,168
Direct transaction costs in the repurchase of Eidos recorded in additional paid-in capital previously classified in prepaid expenses and other current assets $ — $ 8,749
Reconciliation of Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents $ 376,689 $ 393,772
Restricted cash (current) 37,930 177
Restricted cash – included in other assets 2,265 2,416
Total cash, cash equivalents and restricted cash at end of year $ 416,884 $ 396,365
(1) The condensed consolidated financial statements as of and for the year ended December 31, 2021 are derived from the audited consolidated financial statements as of that date.

On February 23, 2023 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health", "BHC", the "Company", or "we") reported its fourth-quarter and full-year 2022 financial results (Press release, Bausch Health, FEB 23, 2023, View Source [SID1234627598]).

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"2022 was a transformative year for Bausch Health, as we executed on our strategic priorities," said Thomas J. Appio, Chief Executive Officer, Bausch Health. "Since completing the initial public offering of Bausch + Lomb last May, we have made significant progress in de-levering our balance sheet, reducing our debt principal net of unrestricted cash by $3.2 billion. We are encouraged by our second half performance and look to build on this momentum. We will invest in sustainable growth drivers across our products and pipeline to position us for long-term success," concluded Appio.

Fourth-Quarter and Full-Year 2022 Revenue Performance
Total reported revenues were $2.2 billion for the fourth quarter of 2022, flat compared with the fourth quarter of 2021. Excluding the unfavorable impact of foreign exchange of $78 million and the impact of divestitures and discontinuations of $6 million, revenue increased by 4% organically1 compared with the fourth quarter of 2021.

Total reported revenues were $8.1 billion for the full year of 2022, compared with $8.4 billion in the full year of 2021, a decrease of $310 million, or 4%. Excluding the unfavorable impact of foreign exchange of $264 million and the impact of divestitures and discontinuations of $178 million, revenue increased organically1 by 2% compared with the full year of 2021.

Revenues by segment were as follows:

Three Months Ended December 31,
(in millions) 2022 2021 Reported Change Reported Change
Change at Constant Currency1
(non-GAAP)
Organic
Change1
(non-GAAP)
Total Bausch Health Revenues $2,193 $2,196 ($3) 0% 3% 4%
Bausch Health (Excl. B+L) $1,197 $1,195 $2 0% 2% 2%
Salix segment $581 $559 $22 4% 4% 4%
International segment2
$261 $276 ($15) (5%) 0% 2%
Solta Medical segment2
$99 $89 $10 11% 20% 20%
Diversified Products segment2
$256 $271 ($15) (6%) (6%) (6%)
Bausch + Lomb segment2
$996 $1,001 ($5) 0% 5% 5%

Twelve Months Ended December 31,
(in millions) 2022 2021 Reported Change Reported Change
Change at Constant Currency1
(non-GAAP)
Organic
Change1
(non-GAAP)
Total Bausch Health Revenues $8,124 $8,434 ($310) (4%) (1%) 2%
Bausch Health (Excl. B+L) $4,356 $4,669 ($313) (7%) (5%) (1%)
Salix segment $2,090 $2,074 $16 1% 1% 1%
International segment2
$988 $1,166 ($178) (15%) (10%) 5%
Solta Medical segment2
$300 $308 ($8) (3%) 2% 2%
Diversified Products segment2
$978 $1,121 ($143) (13%) (13%) (13%)
Bausch + Lomb segment2
$3,768 $3,765 $3 0% 5% 5%

Salix Segment
Salix segment reported and organic1 revenues were $581 million for the fourth quarter and $2,090 million for the full year of 2022, compared with $559 million for the fourth quarter and $2,074 million for the full year of 2021, an increase of $22 million, or 4% in the fourth quarter, and $16 million, or 1% for the full year. Sales growth for the quarter and full year was primarily driven by Xifaxan, Relistor, Trulance and Plenvu.

International Segment2
International segment reported revenues were $261 million for the fourth quarter and $988 million for the full year of 2022, compared with $276 million for the fourth quarter and $1,166 million for the full year of 2021, a decrease of $15 million, or 5% in the fourth quarter, and $178 million, or 15% for the full year.

Excluding the unfavorable impact of foreign exchange of $16 million for the fourth quarter and $65 million for the full year of 2022, and the impact of divestitures and discontinuations of $4 million for the fourth quarter and $167 million for the full year of 2022, segment revenues increased organically1 by 2% for the fourth quarter and 5% for the full year, compared with the fourth quarter and the full year of 2021, primarily driven by Canada and Europe.

Solta Medical Segment2
Solta Medical segment reported revenues were $99 million for the fourth quarter and $300 million for the full year of 2022, compared with $89 million for the fourth quarter and $308 million for the full year of 2021, an increase of $10 million, or 11% in the fourth quarter, and a decrease of $8 million, or 3% for the full year.

Excluding the unfavorable impact of foreign exchange of $8 million for the fourth quarter and $15 million for the full year of 2022, segment revenues increased organically1 by 20% for the fourth quarter and 2% for the full year, compared with the fourth quarter and the full year of 2021, primarily driven by strong results in Asia Pacific (excluding China).

Diversified Products Segment2
Diversified Products segment reported revenues were $256 million for the fourth quarter and $978 million for the full year of 2022, compared with $271 million for the fourth quarter and $1,121 million for the full year of 2021, a decrease of $15 million, or 6% in the fourth quarter, and a decrease of $143 million, or 13% for the full year.

Segment revenues declined organically1 by 6% for the fourth quarter and 13% for the full year, compared with the fourth quarter and the full year of 2021, primarily attributable to declines in Neurology and Generics.

Bausch + Lomb Segment2
Bausch + Lomb segment reported revenues were $996 million for the fourth quarter and $3,768 million for the full year of 2022, compared with $1,001 million for the fourth quarter and $3,765 million for the full year of 2021, a decrease of $5 million, or less than 1% in the fourth quarter, and an increase of $3 million, or less than 1% for the full year.

Excluding the unfavorable impact of foreign exchange of $54 million for the fourth quarter and $184 million for the full year of 2022, and the impact of divestitures and discontinuations of $3 million for the fourth quarter and $10 million for the full year of 2022, segment revenues increased organically1 by 5% for the fourth quarter and for the full year, compared with the fourth quarter and the full year of 2021.

Consolidated Operating (Loss) Income
Consolidated operating loss was $236 million for the fourth quarter of 2022, compared with operating income of $367 million for the fourth quarter of 2021, a decrease of $603 million, primarily driven by a goodwill impairment charge of $622 million in our Neurology business.

Consolidated operating income was $454 million for the full year of 2022, compared with operating income of $450 million for the full year of 2021, an increase of $4 million. The change reflects, among

other factors: a decrease in contribution (product sales revenue less cost of goods sold, exclusive of amortization and impairments of intangible assets) of $271 million, mainly due to the unfavorable impact of foreign currencies and impact of our divestiture of Amoun on July 26, 2021, an increase in Goodwill impairments of $355 million associated with our Neurology and Ortho Dermatologics reporting unit, a decrease in Amortization of intangible assets of $160 million, a decrease in Asset impairments, including loss on assets held for sale of $219 million, primarily attributable to adjustments to the loss on assets held for sale in connection with the Amoun sale during 2021, a favorable change in Other expense, net of $338 million, primarily attributable: (i) to higher adjustments related to the settlements of certain litigation matters during 2021 and (ii) the loss on the completion of the Amoun sale in 2021, partially offset by insurance recoveries related to certain litigation matters.

Net (Loss) Income Attributable to Bausch Health
Net loss attributable to Bausch Health for the fourth quarter of 2022 was $410 million, compared with income of $69 million for the fourth quarter of 2021, an unfavorable change of $479 million. The change was primarily due to the increase in goodwill impairments, partially offset by a gain on extinguishment of debt.

Net loss attributable to Bausch Health for the full year of 2022 was $225 million, compared with a loss of $948 million for the full year of 2021, a favorable change of $723 million. The change was primarily due the changes in operating income as discussed above and gains on extinguishment of debt in 2022 of $875 million.

Adjusted net income attributable to Bausch Health (non-GAAP)1 was $372 million for the fourth quarter and $1,113 million for the full year of 2022, compared with $463 million for the fourth quarter and $1,602 million for the full year of 2021, a decrease of $91 million in the fourth quarter and $489 million for the full year.

Earnings (Loss) Per Share Attributable to Bausch Health
GAAP Earnings Per Share attributable to Bausch Health was ($1.13) for the fourth quarter and ($0.62) for the full year of 2022, compared with $0.19 for the fourth quarter and ($2.64) for the full year of 2021.

Adjusted EBITDA attributable to Bausch Health (non-GAAP)1
Adjusted EBITDA attributable to Bausch Health (non-GAAP)1 was $823 million for the fourth quarter and $3,022 million for the full year of 2022, compared with $909 million for the fourth quarter and $3,472 million for the full year of 2021, a decrease of $86 million in the quarter and $450 million for the full year.

Cash (Used in) Provided by Operating Activities
The Company generated $475 million of cash from operations in the fourth quarter and used cash of $728 million for the full year of 2022, compared with generating $24 million in the fourth quarter and $1,426 for the full year of 2021. The decrease in cash flow from operations of $2,154 million for the full year is primarily attributable to: (i) reductions of restricted cash as certain litigation settlements became final and unappealable, (ii) changes in business performance, (iii) the impact of our divestiture of Amoun on July 26, 2021 and (iv) an increase in payments for separation costs, separation-related costs, IPO costs and IPO-related costs in 2022 as compared to 2021.

Balance Sheet Highlights as of December 31, 2022
•Cash, cash equivalents, and restricted cash were $591 million.
•Executed open market repurchases during the second and fourth quarters of this year, retiring an aggregate of $927 million in principal of bonds for $550 million of cash consideration.
•Reduced debt principal net of unrestricted cash by $3.2 billion since the IPO of B+L.
•Bausch Health (excl. B+L) had availability under its revolving credit facility of approximately $480 million and Bausch + Lomb had availability under its revolving credit facility of approximately $475 million.

2023 Financial Outlook
The Company is not providing consolidated full year guidance, as Bausch + Lomb has not provided full year guidance. Bausch Health (excl. B+L) has provided guidance for the full year of 2023 as follows:
•Full-year revenue range of $4.45 – $4.6 billion
•Full-year adjusted EBITDA (non-GAAP)1 range of $2.3 – $2.4 billion

Other than with respect to GAAP revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP)1 to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP)1. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release. The guidance in this news release is only effective as of the date it is given, and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.

Conference Call Details
Date: Thursday, Feb. 23, 2023
Time: 8:00 a.m. ET
Webcast: View Source

A replay of the conference call will be available on the investor relations website.