On February 19, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its fourth-quarter and full-year 2019 financial results (Press release, Bausch Health, FEB 19, 2020, View Source [SID1234554479]).

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"In 2019, we delivered on our ‘pivot to offense’ strategy. Our fourth-quarter and full-year 2019 results demonstrated the consistency and durability of Bausch Health, as we reported our eighth consecutive quarter of organic revenue growth2 and our first full year of reported revenue growth since 2015," said Joseph C. Papa, chairman and CEO, Bausch Health. "The Salix and Bausch + Lomb/International segments are leading our resurgence with continued strong performance."

"During the year, we invested in our future by increasing our commitment to R&D and by deploying approximately $250 million for bolt-on acquisitions to enhance our current product portfolio and add to our development pipeline," Mr. Papa continued.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

The Bausch + Lomb/International segment comprised approximately 55% of the Company’s reported revenue in 2019
___________________________
1 Please see the tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the nearest comparable GAAP measure.
2 Organic growth/change, a non-GAAP metric, is defined as a change on a period-over-period basis in revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations.

Reported revenue in the Bausch + Lomb/International segment increased by 2% in 2019 compared to 2018; revenue in this segment grew organically1,2 by 5% compared to 2018, driven by organic growth1,2 across all five business units

Delivered third consecutive year of organic revenue growth2 in 2019

Launched multiple products in 2019, including:

Ocuvite Eye Performance vitamins

PreserVision AREDS 2 Formula minigel eye vitamins

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38%

Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses

Zen Multifocal scleral lens for Presbyopia

enVista toric MX60ET intraocular lens

Acquired licensing rights for several investigational products, including:

XIPERE (triamcinolone acetonide suprachoroidal injectable suspension), with a proposed indication of treatment for macular edema associated with uveitis

NOV033 (perfluorohexyloctane), a first-in-class drug with a novel mechanism of action to treat Dry Eye Disease associated with Meibomian gland dysfunction

EM-100, an investigational eye drop that, if approved, will be the first over-the-counter preservative-free eye drop for the treatment of itchy eyes associated with allergies

The Salix segment comprised approximately 23% of the Company’s reported revenue in 2019

Reported revenue in the Salix segment increased by 16% in 2019 compared to 2018

Reported revenue of XIFAXAN (rifaximin) increased by 22% in 2019 compared to 2018

Acquired TRULANCE (plecanatide), a treatment for adults with chronic idiopathic constipation and irritable bowel syndrome with constipation

Acquired dolcanatide, an investigational compound that has demonstrated proof-of-concept in treating patients with multiple gastrointestinal conditions

Entered into a licensing agreement with the University of California, Los Angeles to develop and commercialize a novel investigational compound for the treatment of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis

Acquired licensing rights for MT-1303 (amiselimod), a late-stage investigational sphingosine 1-phosphate (S1P) modulator for the treatment of inflammatory bowel disease, and conducted study to evaluate its cardiovascular safety

The Ortho Dermatologics segment comprised approximately 7% of the Company’s revenue in 2019

Reported revenues in the Global Solta business unit grew by 44% in 2019 compared to 2018, driven by continued strong demand for Thermage FLX system following the launch in the Asia Pacific region

Launched DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, for the topical treatment of plaque psoriasis in adults

Launched a cash-pay prescription program, Dermatology.com, and expanded it to all Walgreens U.S. retail pharmacy locations

Received approval from the U.S. Food and Drug Administration for ARAZLO (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older; launch is planned for the first half of 2020

Strategic Capital Allocation and Debt Management

Increased Research and Development (R&D) in 2019 by 14%, or $58 million, compared to 2018
____________________________
3 The acquisition of licensing rights for NOV03 was announced in late 2019, and the upfront payment was made in early 2020.

Utilized approximately $1.100 billion in cash generated from operations to repay debt by approximately $900 million and for ‘bolt-on’ acquisitions in 2019

Refinanced $4.240 billion of debt in 2019 to extend maturities and provide flexibility

Raised $1.260 billion of debt in 2019 to fund the settlement of the legacy Valeant U.S. ‘stock drop’ litigation and pay the related financing fees and expenses

Fourth-Quarter and Full-Year 2019 Revenue Performance
Total reported revenues were $2.224 billion for the fourth quarter of 2019, as compared to $2.121 billion in the fourth quarter of 2018, an increase of $103 million, or 5%.

Total reported revenues were $8.601 billion for the full year of 2019, as compared to $8.380 billion for the full year of 2018, an increase of $221 million, or 3%. Excluding the unfavorable impact of foreign exchange of $112 million, the impact of a 2019 acquisition of $55 million and the impact of divestitures and discontinuations of $54 million, revenue grew organically1,2 by approximately 4% compared to the full year of 2018, driven by organic growth1,2 in the Salix and Bausch + Lomb/International segments.

Bausch + Lomb/International segment revenues were $1.238 billion for the fourth quarter of 2019, as compared to $1.205 billion for the fourth quarter of 2018, an increase of $33 million, or 3%. Excluding
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4 To assist investors in evaluating the Company’s performance, we have adjusted for changes in foreign currency exchange rates. Change at constant currency, a non-GAAP metric, is determined by comparing 2019 reported amounts adjusted to exclude currency impact, calculated using 2018 monthly average exchange rates, to the actual 2018 reported amounts.

the impact of divestitures and discontinuations of $6 million, the Bausch + Lomb/International segment grew organically1,2 by approximately 3% compared to the fourth quarter of 2018, primarily due to growth in the Global Consumer, Global Surgical and Global Vision Care business units.

Bausch + Lomb/International segment revenues were $4.739 billion for the full year of 2019, as compared to $4.664 billion for the full year of 2018, an increase of $75 million, or 2%. Excluding the unfavorable impact of foreign exchange of $110 million and the impact of divestitures and discontinuations of $41 million, the Bausch + Lomb/International segment grew organically1,2 by 5% compared to the full year of 2018, due to organic growth1,2 across all five business units.

Salix Segment
Salix segment revenues were $517 million for the fourth quarter of 2019, as compared to $426 million for the fourth quarter of 2018, an increase of $91 million, or 21%. The increase was primarily driven by XIFAXAN, which grew 29% as compared to the fourth quarter of 2018.

Salix segment revenues were $2.022 billion for the full year of 2019, as compared to $1.749 billion for the full year of 2018, an increase of $273 million, or 16%. Growth in the segment was primarily driven by higher sales of XIFAXAN, which grew 22% as compared to the full year of 2018, partially offset by the loss of exclusivity of products in the segment, primarily UCERIS (budesonide) and APRISO (mesalamine), which negatively impacted revenues by $96 million.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $158 million for the fourth quarter of 2019, as compared to $160 million for the fourth quarter of 2018, a decrease of $2 million, or 1%. The decline was due to lower volumes primarily driven by the loss of exclusivity of ELIDEL (pimecrolimus) Cream, 1%, ZOVIRAX (acyclovir) Cream, 5%, and SOLODYN (minocycline HCl), partially offset by higher revenues in the Global Solta business unit and revenues from new product launches in the Ortho Dermatologics business unit.

Ortho Dermatologics segment revenues were $565 million for the full year of 2019, as compared to $617 million for the full year of 2018, a decrease of $52 million, or 8%. The decline was due to lower volumes primarily driven by the loss of exclusivity of ELIDEL, ZOVIRAX, SOLODYN and ACANYA (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%, which negatively impacted revenues by $121 million, and was partially offset by higher revenues in the Global Solta business unit and revenues from new product launches in the Ortho Dermatologics business unit.

Diversified Products Segment
Diversified Products segment revenues were $311 million for the fourth quarter of 2019, as compared to $330 million for the fourth quarter of 2018, a decrease of $19 million, or 6%. Diversified Products segment revenues were $1.275 billion for the full year of 2019, as compared to $1.350 billion for the full year of 2018, a decrease of $75 million, or 6%. The decreases in revenue for both the fourth quarter and full year of 2019 were primarily attributed to the previously reported loss of exclusivity for a basket of products.

Operating Results
Operating loss was $1.076 billion for the fourth quarter of 2019, as compared to operating income of $25 million for the fourth quarter of 2018, a decrease of $1.101 billion. The decrease in operating results for the fourth quarter of 2019 was primarily driven by the accrual of legal reserves established

for the resolution of the legacy Valeant U.S. ‘stock drop’ litigation, other related actions and ongoing legacy litigation and investigations, partially offset by lower impairments and increased revenues in the fourth quarter of 2019 versus the fourth quarter of 2018.

Operating loss was $203 million for the full year of 2019, as compared to operating loss of $2.384 billion for the full year of 2018, a favorable change of $2.181 billion. The increase in operating results
primarily reflects goodwill impairment charges recognized in 2018 of $2.322 billion, decreases in the amortization and impairments of intangible assets and increased revenues and gross margins in 2019 versus 2018. The increase in operating results was partially offset by the accrual of legal reserves established for the resolution of the legacy Valeant U.S. ‘stock drop’ litigation, other related actions and ongoing legacy litigation and investigations.

Net Loss
Net loss for the fourth quarter of 2019 was $1.516 billion, as compared to net loss of $344 million for the same period in 2018, an unfavorable change of $1.172 billion. The change is primarily driven by the decrease of $1.101 billion in operating results as discussed above and higher income taxes, partially offset by lower interest expense and debt extinguishment charges.

Net loss for the full year of 2019 was $1.788 billion, as compared to net loss of $4.148 billion for the same period in 2018, a favorable change of $2.360 billion. The change is primarily driven by the increase of $2.181 billion in operating results as discussed above and lower interest expense and debt extinguishment charges.

Adjusted net income (non-GAAP)1 for the fourth quarter of 2019 was $404 million, as compared to $368 million for the fourth quarter of 2018, an increase of $36 million, or 10%.

Adjusted net income (non-GAAP)1 for the full year of 2019 was $1.559 billion, as compared to $1.410 billion for the full year of 2018, an increase of $149 million, or 11%.

Cash Generated from Operations
The Company generated $234 million of cash from operations in the fourth quarter of 2019, as compared to $319 million in the fourth quarter of 2018, a decrease of $85 million, or 27%. The decrease in cash from operations was primarily attributed to the timing of payments and receipts in the ordinary course of business, partially offset by improved operating results.

The Company generated $1.501 billion of cash from operations in 2019, which was in line with 2018.

EPS
GAAP Earnings Per Share (EPS) Diluted for the fourth quarter of 2019 was ($4.30), as compared to ($0.98) for the fourth quarter of 2018. GAAP EPS Diluted for the full year of 2019 was ($5.08), as compared to ($11.81) for the full year of 2018.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $898 million for the fourth quarter of 2019, as compared to $858 million for the fourth quarter of 2018, an increase of $40 million, or 5%.

Adjusted EBITDA (non-GAAP)1 was $3.571 billion for the full year of 2019, as compared to $3.474 billion for the full year of 2018, an increase of $97 million, or 3%. The increase was due to higher

revenues, most notably in the Salix segment, which has favorable gross margins, partially offset by higher operating expenditures to support new product launches and R&D projects.

2020 Financial Outlook
Bausch Health provided guidance for the full year of 2020, as follows:

Full-Year revenues in the range of $8.65 – $8.85 billion

Full-Year Adjusted EBITDA (non-GAAP) in the range of $3.50 – $3.65 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) to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other 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). The guidance provided in this section represents forward-looking information and 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.

Additional Highlights

Bausch Health’s cash, cash equivalents and restricted cash were $3.244 billion5 at Dec. 31, 2019

The Company’s availability under the Revolving Credit Facility was $1.055 billion at Dec. 31, 2019

Basic weighted average shares outstanding for the fourth quarter of 2019 were 352.6 million shares. Diluted weighted average shares outstanding for the fourth quarter of 2019 were 359.2 million shares6

Basic weighted average shares outstanding for the full year of 2019 were 352.1 million shares. Diluted weighted average shares outstanding for the full year of 2019 were 357.2 million shares6

On February 19, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing (Press release, Hoffmann-La Roche, FEB 19, 2020, View Source [SID1234554478]). The FDA is expected to make a decision on approval by June 19, 2020.

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"In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible."

This sBLA is based on results from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.595, 95% CI: 0.398–0.890; p=0.0106) in people with high PD-L1 expression (TC3/IC3-WT). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3–4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.1

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-naïve participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (WT). A total of 572 people (555 WT) were enrolled and were randomised 1:1 to receive:

Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity or death; or
Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.3

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On February 18, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) reported that the United States Patent and Trademark Office (USPTO) has granted Xspray three new US patent for HyNap-Dasa (Press release, Xspray, FEB 18, 2020, View Source [SID1234649567]). The new patents, US10,561,643; US 10,561,644; and US10,561,645, are valid until January 2033. This means that Xspray now has seven product patents for the pharmaceutical composition of the company’s primary product candidate, HyNap-Dasa, in the company’s main market USA.
"With a total of seven patents for HyNap-Dasa in our most important market, we can justifiably state that it will be extremely difficult for other players to launch a dasatinib product based on amorphous solid dispersion in the United States during the lifetime of the patent, ie until January 2033. This is undoubtably very important for our potential partners," says Per Andersson, CEO of Xspray.

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Xspray strives to obtain patents for both composition and technology and these new patents claim an amorphous solid dispersion (pharmaceutical composition) of dasatinib.

On February 18, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that President and CEO Athena Countouriotis, M.D., will participate in the 9th Annual SVB Leerink Global Healthcare Conference on Feb. 27 in New York and the Cowen 40th Annual Healthcare Conference on March 2 in Boston (Press release, Turning Point Therapeutics, FEB 18, 2020, View Source [SID1234564379]).

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Dr. Countouriotis is scheduled to participate in a question and answer session at 10:30 a.m. ET at the SVB Leerink conference, and present a company overview at 2:50 p.m. ET at the Cowen conference. Both sessions will be accessible via audio webcast through the Investors page of www.tptherapeutics.com.

On February 18, 2020, Agenus Inc. (the "Company") reported that it has entered into an amendment (the "Amendment") with certain existing investors, pursuant to which the Company (Filing, 8-K, Agenus, FEB 18, 2020, View Source [SID1234554660]):

extended the maturity date of the $14.0 million senior subordinated promissory notes previously issued in 2015 (the "2015 Notes") by three years from February 20, 2020 to February 20, 2023;

extended the exercise period of the warrants to purchase 1,400,000 shares of the Company’s common stock previously issued in 2015 by three years from February 20, 2020 to February 20, 2023; and

issued new warrants to purchase 675,000 shares of the Company’s common stock with a term of five years and an exercise price of $4.48 per share, which represented a 20% premium over the 30-day average trailing closing price of the Company’s common stock (the "New Warrants").

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A brief description of the terms and conditions of the 2015 Notes can be found in Item 2.03 of the Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on February 26, 2015 and such brief description is incorporated by reference herein.

The securities issued in connection with the Amendment were issued in reliance on the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended (the "Securities Act"). Neither the New Warrants nor the underlying shares of common stock have been registered under the Securities Act. Neither the New Warrants nor such underlying shares of common stock may be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No commission or other remuneration was paid or given directly or indirectly for soliciting such issuance.