On May 10, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that initiated enrollment of patients in the basket portion of the first-in-human study of TH1902, Theratechnologies’ investigational lead peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers (Press release, Theratechnologies, MAY 10, 2022, View Source [SID1234614053]).

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Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies, noted, "We are pleased to move forward to the next stage of development of TH1902, the basket portion of the first-in-human study. We firmly believe that the unique mechanism of entry of TH1902 in cancer cells is a key advantage to improve the therapeutic window of docetaxel. TH1902’s targeted delivery and rapid internationalization in cancer cells via the Sortilin receptor enables the potential to accumulate 7.5 to 10 times more docetaxel in cancer cells — as compared to the administration of docetaxel alone. Based on the pre-clinical results obtained so far, we are optimistic in the development of a first-in-class and promising treatment for patients with Sortilin positive solid tumors. Additionally, we continue to advance the development of our SORT1+ TechnologyTM platform by conjugating our proprietary peptide with other effective anti-cancer agents."

Based on the data of the dose escalation part of the study, the dose of TH1902 for the expansion study was established at 300 mg/m2 or 1.5 times the therapeutic dose of docetaxel alone. No dose limiting toxicities were observed following the completion of the first cycle in the last 6 patients treated at 300 mg/m2. The basket portion of the first-in-human study is an expansion study designed to assess TH1902 as monotherapy treatment of advanced refractory or resistant solid tumor types expressing high levels of Sortilin, including Hormone Receptor-positive (HR+) Breast Cancer, Triple Negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, and Melanoma with approximately 10 patients per tumor type. One arm will include a mix of tumor types including Thyroid, Small Cell Lung, Prostate and potential other high Sortilin expressing cancers with approximately 15 patients in total. In addition to evaluating the anti-tumor activity of TH1902, the study will continue to evaluate the safety and pharmacokinetics of TH1902. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

About TH1902
TH1902 is Theratechnologies’ proprietary peptide drug conjugate (PDC) linked to docetaxel, a well-established and well-characterized cytotoxic agent. TH1902 is being developed as a single agent for the treatment of all advanced solid tumors expressing sortilin that are refractory to standard therapy. TH1902 is the Company’s lead PDC drug candidate stemming from Theratechnologies’ SORT1+ Technology in oncology.

About SORT1+ TechnologyTM
Theratechnologies has developed a peptide which specifically targets sortilin (SORT1) receptors. SORT1 is expressed in ovarian, triple negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development.

Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ investigational novel peptides to specifically target sortilin receptors with the aim of improving the efficacy and safety of those agents.

What is a basket trial?
A type of clinical trial that tests how well a new drug or other substance works in patients who have different types of cancer that all have the same mutation or biomarker. In basket trials, patients all receive the same treatment that targets the specific mutation or biomarker found in their cancer. Basket trials may allow new drugs to be tested and approved more quickly than traditional clinical trials. Basket trials may also be useful for studying rare cancers and cancers with rare genetic changes.

On May 10, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the first quarter ended March 31, 2022, and provided recent corporate updates (Press release, Sensei Biotherapeutics, MAY 10, 2022, View Source [SID1234614052]).

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"We continue to make significant progress in the development of our TMAb platform, which is designed to address the challenge of resistance to checkpoint blockade. New preclinical data show that SNS-101, our anti-VISTA antibody, binds selectively in low-pH environments to inhibit tumor growth, offering high potential for therapeutic benefit while avoiding the pharmacokinetic sinks and on-target, off-tumor toxicities that have made multiple immune targets difficult to drug," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Importantly, we have extended our cash runway into the first quarter of 2025 by prioritizing near-term milestones for SNS-101 and other TMAb programs, while also continuing to optimize our ImmunoPhage platform."

Highlights and Milestones

TMAb (Tumor Microenvironment Activated Biologics) Platform

SNS-101

Sensei continues preclinical studies to evaluate SNS-101, a monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 and correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

In April 2022 Sensei presented preclinical data demonstrating that SNS-101 had a favorable pharmacokinetic profile in a single-dose mouse model. Notably, pH-selective SNS-101 demonstrated a long mean residence time in the blood, indicating a lack of significant target-mediated drug disposition and clearance in non-malignant tissues.
SNS-101 demonstrated synergistic anti-tumor activity in vivo in combination with anti-PD-1 in a MC38 syngeneic tumor model in human VISTA knock-in mice.
SNS-101 has demonstrated great manufacturing productivity to date and Sensei anticipates reviewing pharmacokinetic and toxicology data from its single dose non-human primate studies in mid-2022.
Sensei has initiated GMP manufacturing for SNS-101 and remains on track to submit an IND in the first half of 2023.
SNS-102

Sensei intends to select a product candidate and initiate IND-enabling studies in 2023 for SNS-102, a monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), a B7-family related protein that is frequently overexpressed on tumor-associated macrophages.
VSIG4 is a potent inhibitor of T-cell activity and potential driver of immunosuppressive macrophage polarization. Given its expression within normal tissues and the resulting potential safety challenges, Sensei believes that VSIG4 is an ideal candidate for development through its TMAb platform.
Sensei has generated the first set of parental tumor-selective antibodies targeting VSIG4 aimed at developing an inhibitory antibody with high selectivity for VSIG4 in the tumor microenvironment versus normal tissue environments.
SNS-103

Sensei remains on track to select a product candidate in 2023 for SNS-103, a monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39), the upstream, rate-limiting enzyme leading to the breakdown of extracellular ATP.
ImmunoPhage Platform and SNS-401-NG

Sensei is optimizing its ImmunoPhage platform to offer a potentially transformative approach to generating new T cells to fight cancer, with potential to address multiple tumor types. Current work in this platform area extending into 2023 is focused on SNS-401-NG, a potential first-in-class, multi-antigenic bacteriophage designed to deliver anti-tumor antigens to the immune system. Sensei believes that a measured approach to development will position the company to advance the most potent ImmunoPhage product candidate when ready.

Corporate

In April 2022, Robert Pierce, M.D., Chief R&D Officer, presented an update on SNS-101 at the World Vaccine Congress, held April 18-21, 2022, in Washington DC.
In March 2022, Sensei announced the appointment of William Ringo as Chair of the Board of Directors.
In January 2022, Sensei announced the promotions of Erin Colgan to Chief Financial Officer and Robert Pierce, M.D., to Chief R&D Officer.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $136.2 million as of March 31, 2022, as compared to $147.6 as of December 31, 2021. Sensei expects the current cash balance to fund operations into the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $7.5 million for the quarter ended March 31, 2022, compared to $3.4 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities.

General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the quarter ended March 31, 2022, compared to $4.6 million for the quarter ended March 31, 2021, with the increase mainly driven by franchise tax increases. The company is focused on carefully managing the growth of G&A expenses in the near term.

Net Loss: Net loss was $12.4 million, for the quarter ended March 31, 2022, compared to $8.0 million for the quarter ended March 31, 2021.

On May 10, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the first quarter ended March 31, 2022 (Press release, Athenex, MAY 10, 2022, View Source [SID1234614051]).

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"Our focus for 2022 continues to be on transforming Athenex into a robust, well-positioned cell therapy company with a solid balance sheet. We are proud of the progress we have made since announcing our strategic pivot and remain committed to delivering on cutting operating expenses and executing on additional monetization of noncore assets," said Johnson Lau, Chief Executive Officer of Athenex. "Our cell therapy programs continue to generate exciting data, which we are looking forward to presenting throughout the year. We believe our NKT cell therapy platform will be the main driver of future growth and will position us to be a differentiated leader in cell therapy space. Our corporate initiatives continue to set us up for successful value creation and allow us to further execute on our ultimate mission of bringing innovative treatments to cancer patients."

Corporate Developments

Business Updates

Lowered operating expenses in the first quarter of 2022 by 34% versus the prior year period, with additional cost-cutting underway
APD/APS division delivered four new product launches and generated 42% growth in product revenues during the first quarter of 2022 versus the prior year period
Plan to monetize non-core assets to support development of cell therapy pipeline
Key Anticipated Milestones

Oral presentation of interim analysis of Phase 1 GINAKIT2 study of KUR-501, our autologous GD2 CAR NKT program in pediatric relapsed/refractory high-risk neuroblastoma, at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting on May 16, 2022 at 2:30 p.m. ET
Online presentation of KUR-503 preclinical data, our allogeneic GPC3 CAR-NKT cell program in liver cancer, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 3-7, 2022
Multi-center expansion of CD19 CAR-NKT ANCHOR study of KUR-502 permitted under the newly allowed IND
Data update from ANCHOR study evaluating allogeneic CD19 CAR NKT therapy KUR-502 at American Society of Hematology (ASH) (Free ASH Whitepaper) expected in December 2022
Regulatory interactions with MHRA for Oral Paclitaxel in advanced breast cancer in UK
Phase 2 data from I-SPY 2 trial of Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H 2022
IND filing for KUR-503, our allogeneic CAR-NKT program in liver cancer planned in 2023
First Quarter 2022 and Recent Business Highlights

Clinical Programs

Cell Therapy

Presented interim analysis from ANCHOR study of KUR-502 at the American Society of Transplantation and Cellular Therapy (ASTCT). Reported 60% ORR and 6-month CR rate of 40% in five patients of the NHL cohort, including 1 ongoing CR at 34 weeks. Allogeneic CD19 CAR-NKT cells well tolerated with no cases of cytokine release syndrome (CRS) in the NHL cohort, no immune effector cell-associated neurotoxicity syndrome (ICANS) and no graft versus host disease (GvHD)
Upcoming presentation of abstract from interim analysis of Phase 1 GINAKIT2 study of KUR-501, an autologous GD2 CAR-NKT cell therapy for relapsed/refractory high risk neuroblastoma at ASGCT (Free ASGCT Whitepaper). Data presented shows dose response at low doses of 1×108 cells/m2, including a durable complete response persisting 12 months. Analysis of results found that response correlates with CD62L+ NKT frequency as well as CAR-NKT area under the curve (AUC). Treatment remains well-tolerated with no dose-limiting toxicity, no ICANS, and one case of grade 2 CRS.
Commercial Update

Klisyri (tirbanibulin)

Commercial partner Almirall reported 3.6% market share in the U.S.
Klisyri was granted Medicare coverage and now has 40% coverage
Uptake remains strong in German market, and pre-launch activities in place to support the continued rollout in Europe
American Academy of Dermatology guidelines for the management of actinic keratosis included Klisyri receiving the strongest recommendation
Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 29 products with 54 SKUs.
Athenex Pharma Solutions (APS) currently markets 6 products with 16 SKUs
First Quarter 2022 Financial Highlights

Revenues from product sales increased to $29.0 million for the three months ended March 31, 2022, from $20.4 million for the three months ended March 31, 2021, an increase of $8.6 million or 42%. This increase was primarily attributable to an increase in APD specialty product sales, which increased by $9.5 million as the result of increases in shortage product sales and product launches during 2022.

License fees and other revenue for three months ended March 31, 2022 was $0.8 million, compared to $20.7 million for the same period in 2021, a decrease of $19.9 million. This decrease was primarily due to the recognition of $20.0 million of license revenue pursuant to the 2017 Almirall License Agreement upon the launch of Klisyri in the U.S. during the three months ended March 31, 2021.

Cost of sales for the three months ended March 31, 2022 totaled $23.3 million, an increase of $6.9 million, or 42%, as compared to $16.4 million for the three months ended March 31, 2021. The increase in our cost of specialty product sales was primarily due to an increase in cost of APD and 503B product sales, of $5.7 million and $2.5 million, respectively. These were partially offset by a $1.3 million decrease in cost of API product sales.

R&D expenses totaled $14.0 million for the three months ended March 31, 2022, a decrease of $9.1 million, or 39%, as compared to $23.1 million for the three months ended March 31, 2021. This decrease was primarily due to a decrease in Oral Paclitaxel product development and medical affairs costs, costs of clinical and regulatory operations, and costs of preclinical operations.

SG&A expenses totaled $14.9 million for the three months ended March 31, 2022, a decrease of 28% as compared to $20.7 million for the three months ended March 31, 2021. The decrease was primarily due to a $6.7 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020, partially offset by a $1.3 million increase in operating costs.

Interest income and interest expense totaled $0.1 million and $4.5 million, respectively, for the three months ended March 31, 2022. Interest income and interest expense for three months ended March 31, 2021 totaled less than $0.1 million and $4.9 million, respectively. Interest expense in both periods was incurred from the Senior Credit Agreement with Oaktree.

Income tax expense for the three months ended March 31, 2022 amounted to less than $0.1 million, compared to $0.2 million for the same period in 2021. We did not record a provision for U.S. federal income taxes for the three months ended March 31, 2022, because we expect to generate a loss for the year ending December 31, 2022.

Net loss attributable to Athenex for the three months ended March 31, 2022 was $17.4 million, or ($0.16) per diluted share, as compared to a net loss of $25.1 million, or ($0.27) per diluted share, for the same period in 2021.

For further details on the Company’s financial results, including the results for the three months ended March 31, 2022, refer to the Form 10Q filed with the SEC.

2022 Financial Guidance

Athenex now expects product sales growth to be in the range of 20-25% over the prior year period, versus the prior range of 15-20% growth, year-over-year, due to the strong performance of Athenex’s APD/APS division, earlier than expected NY State license, and the robust pipeline of launches planned for the remainder of 2022.

Cash Conservation Update

As of March 31, 2022, the Company had cash and cash equivalents of $27.2 million, restricted cash of $13.8 million, and short-term investments of $10.2 million, for a total of $51.2 million. The Company is implementing cost savings programs and monetizing non-core assets, and as the Company completes such activities, the Company plans to extend its cash runway into next year.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Tuesday, May 10, 2022, at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

On May 10, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three and six months ended March 31, 2022 and provided a business update (Press release, Sonnet BioTherapeutics, MAY 10, 2022, View Source [SID1234614050]).

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"We are excited to have initiated the first clinical trial with our lead Fully Human Albumin Binding pipeline asset, SON-1010," said Pankaj Mohan, Ph.D., Founder and CEO. "This represents a great accomplishment for our research team, and we look forward to continuing the progress by also advancing SON-080 into the clinic by mid-year. Additionally, we plan to initiate a non-human primate non-GLP toxicology study for SON-1210 later this quarter."

"We continue to focus on our financing strategy and are on track with our R&D activities in 2022. We believe there is significant value in our pipeline that is not reflected in our current valuation that we will seek to unlock during this pivotal year for Sonnet," commented Jay Cross, CFO.

FY 2022 Second Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates for the 2022 calendar year:

●IND cleared for SON-1010 and clinical trial initiated; initial safety data for this study are anticipated in the second half of 2022.
●Continued cGMP manufacturing of SON-080, with clinical study initiation planned for the first half of 2022 in patients with Chemotherapy Induced Peripheral Neuropathy (CIPN).
●Preparing initiation of a non-GLP pre-clinical toxicity study of SON-1210 in non-human primates in the second quarter of 2022.
●Completed sequence confirmation for SON-3015 and preparing for initial in vivo mice studies in the second half of 2022.
●Lead optimization is underway to initiate chemistry, manufacturing and controls (CMC) with cell line development for SON-1410 in the second quarter of 2022.

FY 2022 Second Quarter Ended March 31, 2022 Financial Results

●As of March 31, 2022, Sonnet had $13.6 million cash on hand.
●Research and development expenses were $6.4 million for the three months ended March 31, 2022, compared to $3.8 million for the three months ended March 31, 2021. The increase of $2.6 million was primarily due to the development of the cell lines for SON-1010, SON-1210 and SON-080, and an increase in payroll and share-based compensation expense as we continue to expand our operations.
●General and administrative expenses were $1.9 million for the three months ended March 31, 2022, compared to $2.2 million for the three months ended March 31, 2021. The decrease of $0.3 million was primarily due to a decrease in payroll expense.

On May 10, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its first-quarter 2022 financial results (Press release, Bausch Health, MAY 10, 2022, View Source [SID1234614049]).

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"Our organic3 growth in the first quarter of 2022 was stable compared to the same quarter last year, despite incremental macro pressures and a challenging supply chain environment," said Thomas J. Appio, incoming chief executive officer ("CEO"), Bausch Health. "Following the closing of the initial public offering of the Bausch + Lomb eye health business later today, we will operate as two companies, which enables Bausch Health to increase its focus on accelerating growth with strategic commercial investments and expanding our pipeline with innovative products that improve the quality of life for patients around the world."

Bausch + Lomb Launches IPO and Begins Trading Under "BLCO" Ticker; Bausch Health Will Separate Chairman and CEO Roles
Bausch Health’s eye health business, Bausch + Lomb, which launched its initial public offering ("IPO") and subsequently began trading under the ticker "BLCO" on May 6, 2022, expects the IPO to close today, May 10, 2022. Bausch + Lomb remains on track to spin off from Bausch Health, following the expiry of customary lock-ups related to the IPO, achievement of target net leverage ratios and subject to market conditions, receipt of applicable shareholder and other necessary approvals.2 The Company expects to close the IPO with $630 million in gross proceeds to be applied for the repayment of Bausch Health’s long-term debt on May 10, 2022.

Mr. Appio will assume the role of CEO of Bausch Health, effective upon the closing of the IPO of Bausch + Lomb. The Company also separated the roles of chairman and CEO, with Joseph C. Papa remaining as Chairman until the full separation of Bausch + Lomb. Mr. Papa will be succeeded by Robert N. Power.4

1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the most directly comparable GAAP measure.
2 The Bausch + Lomb common shares have been approved for listing on the New York Stock Exchange ("NYSE") and conditionally approved for listing on the Toronto Stock Exchange ("TSX"). The common shares began trading on the NYSE and on an "if, as and when issued basis" on the TSX on May 6, 2022; and the IPO is expected to close on May 10, 2022, subject to customary closing conditions.
3 Organic growth/change, a non-GAAP ratio, is defined as a change on a period-over-period basis in reported revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations.
4 All leadership and board appointments are conditional and effective upon the closing of the IPO of Bausch + Lomb.

First-Quarter 2022 Revenue Performance
Total reported revenues were $1.918 billion for the first quarter of 2022, as compared to $2.027 billion in the first quarter of 2021, a decrease of $109 million, or 5%. Excluding the unfavorable impact of foreign exchange of $41 million and the impact of divestitures and discontinuations of $72 million, primarily due to the divestiture of Amoun Pharmaceutical Company S.A.E. ("Amoun") on July 26, 2021, revenue was flat organically1,3 when compared to the first quarter of 2021.

Revenues by segment were as follows:

Salix Segment
Salix segment reported and organic1,3 revenues were $464 million for the first quarter of 2022, as compared to $472 million for the first quarter of 2021, a decrease of $8 million, or 2%. The decrease was primarily driven by lower volumes due to the loss of exclusivity of certain products, partially offset by increased sales of XIFAXAN (rifaximin), TRULANCE (plecanatide) and PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), which grew by 1%, 14% and 60%, respectively, compared to the first quarter of 2021.

International Segment5
International segment reported revenues were $244 million for the first quarter of 2022, as compared to $306 million for the first quarter of 2021, a decrease of $62 million, or 20%. Excluding the unfavorable impact of foreign exchange of $12 million and the impact of divestitures and discontinuations of $69 million, primarily due to the divestiture of Amoun on July 26, 2021, International segment revenues increased organically1,3 by 8% compared to the first quarter of 2021.

Diversified Products Segment5
Diversified Products segment reported and organic1,3 revenues were $249 million for the first quarter of 2022, as compared to $296 million for the first quarter of 2021, a decrease of $47 million, or 16%, primarily attributable to a decrease in volumes, partially offset by an increase in net realized pricing.

___________________________________
5 Commencing in the first quarter of 2022, the Company realigned its segment reporting structure and now operates in the following reportable segments: Salix, International, Diversified Products, Solta Medical and Bausch + Lomb. Under the new segment structure, Ortho Dermatologics is now part of the current Diversified Products segment and the Solta reporting unit is now the sole reporting unit of the Solta Medical segment.
6 To assist investors in evaluating the Company’s performance, reported sales are adjusted for changes in foreign currency exchange rates. Change at constant currency, a non-GAAP ratio, is determined by comparing 2022 reported amounts adjusted to exclude currency impact, calculated using 2021 monthly average exchange rates, to the actual 2021 reported amounts.

Solta Medical Segment5
Solta Medical segment reported and organic1,3 revenues were $72 million for the first quarter of 2022, which was flat with the first quarter of 2021, which reflects an increase in net realized pricing, offset by a decline in volumes primarily due to inventory shortfalls resulting from the impact of lockdowns in China due to the new COVID-19 variant and microchip supply chain constraints.

Bausch + Lomb Segment5
Bausch + Lomb segment reported revenues were $889 million for the first quarter of 2022, as compared to $881 million for the first quarter of 2021, an increase of $8 million, or 1%. Excluding the unfavorable impact of foreign exchange of $29 million and the impact of divestitures and discontinuations of $3 million, the Bausch + Lomb segment increased organically1,3 by approximately 5% compared to the first quarter of 2021, primarily due to higher sales in the global Vision Care business, including LUMIFY (brimonidine tartrate ophthalmic solution 0.025%), Biotrue Multi-Purpose Solution and Ocuvite/PreserVision, and higher sales in the Global Surgical business.

Operating Results
Operating income was $285 million for the first quarter of 2022, as compared to an operating loss of $221 million for the first quarter of 2021, a favorable change of $506 million, primarily driven by a goodwill impairment charge of $469 million in our Ortho Dermatologics business that occurred in the first quarter of 2021, a decrease in asset impairments, including the loss associated with the sale of Amoun on July 26, 2021, and a decrease in amortization of intangible assets.

Net Loss
Net loss for the first quarter of 2022 was $69 million, as compared to $610 million for the first quarter of 2021, a favorable change of $541 million. The change was primarily due to the increase in operating results discussed above.

Adjusted net income (non-GAAP)1 for the first quarter of 2022 was $263 million, as compared to $370 million for the first quarter of 2021, a decrease of $107 million.

Cash from Operations
Cash used by operations was $63 million in the first quarter of 2022, as compared to cash generated from operations of $443 million in the first quarter of 2021, a decrease of $506 million. The decrease is primarily attributable to $349 million in payments of legacy legal settlements and the timing of payments in the ordinary course of business.

Earnings Per Share
GAAP Earnings Per Share ("EPS") Diluted for the first quarter of 2022 was ($0.19), as compared to ($1.71) for the first quarter of 2021.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $732 million for the first quarter of 2022, as compared to $852 million for the first quarter of 2021, a decrease of $120 million, primarily due to the divestment of Amoun on July 26, 2021; increased Selling, General & Administrative expenses due to profit protection measures taken in the first quarter of 2021 to manage and reduce our operating expenses and preserve cash during the COVID-19 pandemic; and increased R&D spending.

Balance Sheet Highlights:
•First-quarter cash, cash equivalents, restricted cash and other settlement deposits were $2.460 billion7 on March 31, 2022
•Gross proceeds from the IPO2 of $630 million and from Bausch + Lomb’s debt financing of $2.5 billion are expected upon closing and will be used to reduce Bausch Health’s total long-term debt
•The Company’s availability under its 2023 Revolving Credit Facility was $1.171 billion at March 31, 2022

Select Company and Pipeline Highlights
•Launched XIPERE8 (triamcinolone acetonide injectable suspension), a therapy that uses the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, in the United States
•Launched Bausch + Lomb ULTRA ONE DAY daily disposable silicone hydrogel contact lenses in 14 markets in Europe and Malaysia
•Reported revenues for Clear + Brilliant franchise increased by 27% during the first quarter of 2022 compared to the first quarter of 2021
•Published new data in Advances In Therapy on the cost impact of treating opioid-induced constipation with FDA-approved medications, including RELISTOR subcutaneous injection (methylnaltrexone bromide), in the Emergency Department
•To date, 83 patients have been enrolled in Phase 2 trial evaluating amiselimod (S1P modulator) for the treatment of mild to moderate ulcerative colitis
•Global enrollment continues in the Phase 3 trial evaluating the use of rifaximin SSD for the prevention of cirrhosis complications – hepatic encephalopathy, and the Company is preparing for regulatory meetings outside of the United States
•Received regulatory approval for LUMIFY (brimonidine tartrate ophthalmic solution 0.025%) and VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in Lebanon; VYZULTA is now approved in 17 countries

2022 Financial Outlook
Bausch Health updated its guidance for the full year of 2022 as follows:
•Full-Year revenue range of $8.25 – $8.40 billion, reaffirming organic1,3 growth of 3 – 5%
•Full-Year Adjusted EBITDA (non-GAAP)1 range of $3.225 – $3.375 billion, including $100 million of the previously disclosed $150 million annual run rate of dis-synergies

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
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7 Cash, cash equivalents, restricted cash and other settlement deposits includes restricted cash of $1.210 billion of payments into an escrow fund under the terms of a settlement agreement regarding certain U.S. securities litigation (subject to an objector’s appeal of the final court approval of the agreement).
8 In 2019, the Company acquired an exclusive license from Clearside Biomedical, Inc. for the commercialization and development of XIPERE in the United States and Canada.

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.