On November 3, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its third-quarter 2020 financial results (Press release, Bausch Health, NOV 3, 2020, View Source [SID1234569748]).

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"Bausch Health’s third-quarter 2020 results clearly demonstrate our recovery from the COVID-19 pandemic is in progress. In the third quarter, total company reported revenue grew 28% sequentially from the second quarter. Many of our durable brands are well-positioned to grow market share and return to growth, however, some of our prescription products are taking longer to return to pre-pandemic levels," said Joseph C. Papa, chairman and CEO, Bausch Health. "Throughout the pandemic, we have carefully managed our expenses, have prioritized our resources strategically, such as enhancing our e-commerce capabilities, and have maintained ample supply of our health care products for our customers and patients, and we will continue to do what’s right for all our stakeholders."

"We are also making good progress on our intention to separate our eye health business into an independent public company. As we look toward the future, we are excited about several new pipeline opportunities we are pursuing in areas of critical unmet medical need within eye health, including myopia, dry eye disease and age-related macular degeneration," continued Mr. Papa.

Executing on Core Businesses and Advancing Pipeline
•The Bausch + Lomb/International segment comprised approximately 55% of the Company’s reported revenue in the third quarter of 2020
◦Reported revenue in the Bausch + Lomb/International segment decreased 1% compared to the third quarter of 2019; revenue in this segment was flat organically1,2 compared to the third quarter of 2019
◦Launched Bausch + Lomb INFUSE silicone hydrogel (SiHy) daily disposable contact lenses in the United States

◦Received approvals from Health Canada and the Australian Therapeutic Goods Administration for BAUSCH + LOMB ULTRA ONE DAY silicone hydrogel (SiHy) daily disposable contact lenses
◦Received approval from the U.S. Food and Drug Administration (FDA) for Alaway Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100)
◦Entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro Ophthalmics, LLC, including global rights for risuteganib (Luminate)3
◦Acquired an exclusive license from Eyenovia, Inc. in the United States and Canada for the development and commercialization of an investigational microdose formulation of atropine ophthalmic solution, which is being investigated for the reduction of pediatric myopia progression in children ages 3-12
◦Acquired an exclusive global license from BHVI for a myopia control contact lens design
•The Salix segment comprised approximately 23% of the Company’s reported revenue in the third quarter of 2020
◦Reported and organic1,2 revenue in the Salix segment decreased by 10% compared to the third quarter of 2019
◦Reported revenue for TRULANCE (plecanatide) increased by 57% compared to the third quarter of 2019
◦The FDA granted Orphan Drug Designation to rifaximin for the treatment of sickle cell disease
•The Ortho Dermatologics segment comprised approximately 7% of the Company’s reported revenue in the third quarter of 2020
◦Reported revenue in the Ortho Dermatologics segment decreased by 2% compared to the third quarter of 2019; revenue in this segment decreased organically1,2 by 3% compared to the third quarter of 2019
◦Reported revenue for the Thermage franchise increased by 77% compared to the third quarter of 2019
•Released both Bausch Foundation Inaugural Activity Report and the Company’s annual Corporate Social Responsibility report in September 2020

Debt Management
•Repaid debt by approximately $100 million in the third quarter of 2020 for a total of approximately $420 million to date in 2020 with cash generated from operations
•Bausch Health has no debt maturities or mandatory amortization payments until 2023

Resolving Legal Matters
•Resolved outstanding intellectual property disputes with Sun Pharmaceutical Industries Ltd. regarding XIFAXAN (rifaximin) 200 mg and 550 mg tablets. Salix will maintain market exclusivity for XIFAXAN until 20284

Third-Quarter 2020 Revenue Performance
Total reported revenues were $2.138 billion for the third quarter of 2020, as compared to $2.209 billion in the third quarter of 2019, a decrease of $71 million, or 3%. Revenue was negatively impacted by approximately $150 million in the third quarter of 2020 due to the impact of the COVID-19 pandemic.
Excluding the unfavorable impact of foreign exchange of $6 million and the impact of divestitures and discontinuations of $4 million, revenue declined 3% organically1,2 compared to the third quarter of 2019.
Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.169 billion for the third quarter of 2020, as compared to $1.175 billion for the third quarter of 2019, a decrease of $6 million, or 1%. Excluding the unfavorable impact of foreign exchange of $7 million and the impact of divestitures and discontinuations of $3 million, the Bausch + Lomb/International segment was flat organically1,2 compared to the third quarter of 2019 primarily due to the impact of the COVID-19 pandemic.

Salix Segment
Salix segment revenues were $496 million for the third quarter of 2020, as compared to $551 million for the third quarter of 2019, a decrease of $55 million, or 10%. The decrease was primarily driven by the loss of exclusivity of products in the segment, primarily APRISO (mesalamine), which negatively impacted revenues by approximately $25 million; by an expected decline for GLUMETZA (metformin hydrochloride), whose revenue declined by $21 million due to reduced net selling prices; and by the impact of the COVID-19 pandemic, including the impact to sales of XIFAXAN, which declined by 3% compared to the third quarter of 2019.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $144 million for the third quarter of 2020, as compared to $147 million for the third quarter of 2019, a decrease of $3 million, or 2%. Excluding the favorable impact of foreign exchange of $1 million, the Ortho Dermatologics segment declined organically1,2 by approximately 3% compared to the third quarter of 2019 primarily driven by the loss of exclusivity of products in the segment, primarily ELIDEL (pimecroliumus) Cream, 1%, which negatively impacted revenues by approximately $15 million.

Diversified Products Segment
Diversified Products segment revenues were $329 million for the third quarter of 2020, as compared to $336 million for the third quarter of 2019, a decrease of $7 million, or 2%. The decrease was primarily attributable to the previously reported loss of exclusivity for a basket of products and the impact of the COVID-19 pandemic.
Operating Results
Operating income was $460 million for the third quarter of 2020, as compared to operating income of $329 million for the third quarter of 2019, an increase of $131 million. The increase in operating results was primarily due to decreases in amortization of intangible assets, selling, general and administrative expenses, asset impairments and R&D expenses partially offset by decreases in revenues and gross margins primarily due to the impact of the COVID-19 pandemic, as discussed above.

Net Income
Net income was $71 million for the third quarter of 2020, as compared to net loss of $49 million for the third quarter of 2019, a favorable change of $120 million. The change was primarily driven by the increase in operating results discussed above and lower interest expense partially offset by an increase in our provision for income taxes.

Adjusted net income (non-GAAP)1 for the third quarter of 2020 was $469 million, as compared to $425 million for the third quarter of 2019, an increase of $44 million, or 10%.

Cash Generated from Operations
The Company generated $256 million of cash from operations in the third quarter of 2020, as compared to $515 million in the third quarter of 2019, a decrease of $259 million. The decrease in cash from operations was primarily attributed to lower volumes and the timing of cash receipts as a result of the COVID-19 pandemic and also includes a payment of $45 million for the resolution of the legacy investigation by the U.S. Securities and Exchange Commission.

EPS
GAAP Earnings Per Share (EPS) Diluted for the third quarter of 2020 was $0.20, as compared to ($0.14) for the third quarter of 2019.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $948 million for the third quarter of 2020, as compared to $942 million for the third quarter of 2019, an increase of $6 million, or 1%. The increase was primarily due to decreases in selling, general and administrative expenses partially offset by decreases in revenues and gross margins primarily due to the impact of the COVID-19 pandemic, as discussed above.

2020 Financial Outlook
Bausch Health reaffirmed its revenue and Adjusted EBITDA (non-GAAP) guidance ranges for the full year of 2020, reflecting management’s current expectations. This assumes there are no material restrictions on access to health care products and services resulting from a possible resurgence of the virus on a global basis in the fourth quarter of 2020; the strict social restrictions seen earlier this year will not be materially re-enacted in the event of a material resurgence of the virus; rates of recovery will vary by geography and business unit; and an ongoing gradual global recovery as the macroeconomic and health care impacts of the COVID-19 pandemic run their course. Bausch Health’s guidance ranges are as follows:
•Full-year revenue range of $7.80 – $8.00 billion
•Full-year Adjusted EBITDA (non-GAAP) range of $3.15 – $3.30 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 full-year guidance ranges have been lowered primarily due to the actual and anticipated impacts of the COVID-19 pandemic. These impacts have affected the Company’s assumptions regarding base performance and growth rates. 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.

Additional Highlights
•Bausch Health’s cash, cash equivalents and restricted cash were $1.988 billion6 at Sept. 30, 2020
•The Company’s availability under the Revolving Credit Facility was $1.118 billion at Sept. 30, 2020
•Basic weighted average shares outstanding for the quarter were 355.6 million shares. Diluted weighted average shares outstanding for the quarter were 357.8 million shares

On November 3, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that treatment has commenced in a 64/67Cu-SARTATETM theranostic trial of paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City (Press release, Clarity Pharmaceuticals, NOV 3, 2020, View Source [SID1234569699]).

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The first patient was treated with 67Cu-SARTATE therapy following a positive diagnostic scan with 64Cu-SARTATE and is progressing through the study assessments as planned. Patient recruitment continues at MSK and will be expanding to other clinical sites across the United States (U.S.) in the coming months (ClinicalTrials.gov Identifier: NCT04023331)1.

"We are very excited to commence the treatment of neuroblastoma patients with SARTATE, especially given the great promise of both the diagnostic and therapeutic products in changing the treatment outcomes in these children," commented Dr Alan Taylor, Clarity’s Executive Chairman. "We are looking forward to building more data as we expand the trial to include additional clinical sites and recruit more patients with high-risk neuroblastoma into the study. We are very hopeful that 64/67Cu-SARTATE will save and improve lives of children with this insidious disease."

The SARTATE neuroblastoma trial uses the next-generation radiopharmaceutical pair of 64Cu-SARTATE and 67Cu-SARTATE to assess and treat paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial being conducted in the U.S. Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

Dr Taylor continued: "Our team is pleased to have received very strong support from our numerous collaborators in the clinical development of 64/67Cu-SARTATE in neuroblastoma. We have also recently been granted Orphan Drug Designation as well as two Rare Paediatric Disease Designations for the diagnostic and therapeutic application of SARTATE in neuroblastoma by the U.S. Food and Drug Administration (FDA). These regulatory milestones will enable us to progress SARTATE through clinical development in a swift and cost-effective manner and make Clarity eligible for two Priority Review Vouchers (PRV) upon FDA marketing approval of the diagnostic and therapeutic products. PRVs, which allow for the faster processing of new drug applications through the FDA, are tradable and currently have a market value of approximately USD100 million each. The awarding of these two PRVs will underpin our extensive theranostic development pipeline as we look to progress treatments in other cancers including prostate and breast, as well as neuroendocrine tumours.

"From all the support and positive feedback from the industry that we have received to date, it is clear that the development of next-generation diagnostic and therapeutic tools as well as novel treatment strategies are imperative to improving treatment outcomes for children with high risk neuroblastoma who currently have very poor prognosis and few treatment options. Clarity and our collaborators remain focused on the important goal of developing better treatments for children with cancer and we look forward to further progressing the development of SARTATE together," Dr Taylor said.

On November 2, 2022 Wildflower Biopharma reported the National Institute of Health rewarded a grant this fall to the company (Press release, Wildflower Biopharma, NOV 2, 2020, View Source [SID1234632139]). The work/research is explained in the Grant Title: "Efficacy of a novel small-molecule splicing modulator in chronic lymphocytic leukemia (CLL)".

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The Wildflower Team is excited to announce that the Grant work will be performed at BioLabs San Diego and in collaboration with Huidong Shi at the Department of Biochemistry and Molecular Biology at Augusta University, Georgia.

On November 2, 2020 ABL Bio and LegoChem Biociences have reported the signing of a memorandum of understanding(MOU) to expand their partnership on ADC technology (Press release, ABL Bio, NOV 2, 2020, View Source [SID1234628153]). The agreement draws attention as it comes shortly after ABL202(LCB71), an ADC co-developed by the two companies, was licensed out to CStone Pharmaceuticals

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Under the agreement, the two companies will cooperate on two additional projects, totaling their joint projects to four. While their previous focus was on treatments that combine monoclonal antibodies with LCB’s platform technology, such as ABL202(LCB71), their new projects will center on bispecific antibody ADCs that global pharmaceutical companies are increasingly viewing as a promising sector

This new agreement by ABL Bio and LCB reflect the growing interest in ADC technology. Gilead Sciences recently announced its decision to acquire Immunomedics for approximately $21 billion, at $88 per share in cash. MSD signed a $1.6 billion deal with Seattle Genetics on two new oncology projects. AstraZeneca and Daiichi Sankyo also entered collaboration for the global development and commercialization of another ADC

ABL Bio has the knowledge and proven experience of bispecific antibodies, having acquired a set of bispecific antibody platforms. Combining the company’s BsAb specialty with LCB’s linker and ConjuAllTM Site-specific conjugation technology is anticipated to create a synergy effect in developing next-generation ADCs

Yong-Zu Kim, CEO of LCB said ""Four years of joint research have allowed ABL Bio and LegoChem Biosciences to understand each other’s strengths and build trust. Our long-standing relationship will lead to a much more accelerated and efficient research collaboration

Sang Hoon Lee, CEO of ABL Bio said "We are happy to announce our two companies’ expanded cooperation in ADC technology. On the backdrop of the recent success of achieving a licensing deal for ABL202, ABL Bio and LCB will work closely together to continue this momentum."

On November 2, 2020 Rexahn Pharmaceuticals, Inc. (NASDAQ:REXN) ("Rexahn") reported that at its special meeting of stockholders held on November 2, 2020, Rexahn’s stockholders approved all of the proposals presented, including: (i) the issuance of shares of Rexahn common stock pursuant to the Agreement and Plan of Merger and Reorganization, dated June 17, 2020, as amended, by and among Rexahn, Razor Merger Sub, Inc. and Ocuphire Pharma, Inc. ("Ocuphire") and the change of control of Rexahn resulting from the merger; (ii) a reverse stock split of Rexahn common stock, at a ratio of one new share for every 3 to 5 shares outstanding, with such final ratio to be approved by Rexahn’s board of directors; (iii) changing the name of Rexahn from "Rexahn Pharmaceuticals, Inc." to "Ocuphire Pharma, Inc."; (iv) the adoption of the Ocuphire Pharma, Inc. 2020 Equity Incentive Plan; and (v) the issuance of shares of Rexahn common stock upon the exercise of warrants to be issued in the pre-merger financing and the issuance of additional shares of Rexahn common stock that may be issued following the closing of the pre-merger financing (Press release, Rexahn, NOV 2, 2020, View Source [SID1234584259]).

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"We appreciate the participation and support from our stockholders regarding the upcoming merger transaction with Ocuphire," commented Douglas Swirsky, President and CEO of Rexahn. "Ocuphire’s Board of Directors and President and CEO Mina Sooch are well positioned to guide the combined company forward with an exciting late-stage pipeline of ophthalmic therapeutic candidates and multiple potential value inflection points in 2021."

With the recent approvals by the stockholders of both Rexahn and Ocuphire, and as previously announced, the unanimous approval by the Boards of Directors of both Rexahn and Ocuphire, the merger is expected to be consummated on or about November 5, 2020, subject to the satisfaction of certain closing conditions. In connection with the closing of the merger, Rexahn will change its name to Ocuphire Pharma, Inc. and the combined company’s shares are expected to commence trading on the Nasdaq Capital Market under the symbol "OCUP".

The final voting results for Rexahn’s special meeting of stockholders will be filed with the Securities and Exchange Commission (the "SEC") in a Current Report on Form 8-K.