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Magenta Therapeutics Reports Recent Business Highlights and First Quarter Financial Results

On May 7, 2020 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, reported recent business highlights and financial results for the first quarter ended March 31, 2020 (Press release, Magenta Therapeutics, MAY 7, 2020, View Source [SID1234557315]).

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"The first quarter of 2020 has shown Magenta to be well-positioned to advance our programs and to weather unexpected obstacles. Magenta continues to execute and progress our pipeline, and we remain committed wholeheartedly to our patients, their families, our employees and our business partners," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta. "In this first quarter, Magenta has showcased significant clinical and preclinical results, and we are building on these results to advance quickly."

Recent Business Highlights:

MGTA-117 lead clinical candidate for conditioning for stem cell transplant and gene therapy demonstrates broad therapeutic index; advancing MGTA-117 to deliver initial clinical data in 2021. Data presented at the Transplant and Cellular Therapies (TCT) conference in February 2020 demonstrated that MGTA-117’s optimized linker payload resulted in potent depletion of stem and progenitor cells with an improved therapeutic index of 30 (range for approved ADCs at this stage of development has been two- to six- fold). The ADC is advancing in GMP manufacture. Magenta will also present data in an oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual conference, to be held May 12-15, demonstrating that a single dose of CD117-ADC enables hematopoietic stem cell (HSC)-based gene therapy in non-human primates.

The Company is scaling up manufacturing of MGTA-117 and expects to complete investigational new drug (IND)-enabling studies in 2020. This program is on track to complete GLP toxicology studies and progress GMP manufacturing in 2020, as well as to deliver initial clinical data in 2021.

Announced research and clinical collaboration agreement with AVROBIO to evaluate potential utility of MGTA-117 targeted ADC for conditioning patients with one or more AVROBIO lentiviral gene therapies. The collaboration will combine Magenta’s leadership in ADC-based conditioning with AVROBIO’s expertise in lentiviral gene therapies and will further the two companies’ shared mission to allow patients to live free from disease. Under the collaboration, Magenta and AVROBIO will jointly evaluate MGTA-117 in conjunction with one or more of AVROBIO’s investigational gene therapies. Magenta will retain all commercial rights to MGTA-117. AVROBIO will retain all commercial rights to its gene therapies and will be responsible for the clinical trial costs related to the evaluation of MGTA-117 with AVROBIO’s gene therapies.

The Phase 1 trial of MGTA-145, Magenta’s first-line stem cell mobilization therapy, met all primary and secondary endpoints, demonstrating rapid, same-day first line stem cell mobilization and collection in healthy volunteers, and enrollment in the renal pharmacokinetic study is complete. At TCT in February, Magenta presented data showing MGTA-145 was safe and well tolerated as a single agent and in combination with plerixafor and demonstrated rapid, same-day mobilization and collection of sufficient numbers of stem cells to enable a successful transplant.

Based on the results of the Phase 1 study, Magenta intends to initiate multiple Phase 2 trials of MGTA-145 which may be staggered over the course of this year due to clinical trial impacts from COVID-19. The Phase 2 trials will include both allogeneic and autologous transplant settings and will evaluate mobilization and collection of functional cells and engraftment of the cells after transplant to rebuild the immune system. There is potential for the Company to present initial Phase 2 data on MGTA-145 in 2020.

At the upcoming ASGCT (Free ASGCT Whitepaper) conference, Magenta will present two sets of preclinical data on MGTA-145. In one study, MGTA-145 plus plerixafor was shown to be a rapid, reliable, efficient and G-CSF-free method to obtain high numbers of HSCs, including HSCs that were gene-modified with robust and durable engraftment, which could be used to improve HSC collection and autologous gene therapy outcomes for a variety of therapeutic indications. In a separate preclinical study, MGTA-145 plus plerixafor was shown to serve as an efficient same-day mobilization regimen for in vivo gene therapy of HSCs, which could be applicable in patients with sickle cell disease and other genetic disorders.

IND-enabling work on CD45-ADC for immune system reset will progress in 2020, with lead antibody identified. Magenta is developing targeted ADCs designed to precisely remove the disease-causing cells in the body without the need for chemotherapy or radiation. Magenta’s CD45-ADC program targets CD45, a protein expressed on immune cells and stem cells and is designed to remove the cells that cause autoimmune diseases in order to enable curative immune reset.

Enrollment timelines for the MGTA-456 Phase 2 trial in inherited metabolic disorders have been shifted into 2021, due to COVID-19-related impacts. The trial remains open with seven of 12 patients enrolled and continued longer term follow-up on these patients will be conducted. Sixteen patients have been enrolled in the Phase 2 trial of MGTA-456 in patients with blood cancers at the University of Minnesota, and this trial is currently expected to complete enrollment in 2020.

Expanded senior leadership team. In February 2020, Magenta announced it had expanded its senior leadership with two new strategic hires, Kristen Stants as Chief People Officer, and Li Malmberg, Ph.D., as Senior Vice President, Head of Manufacturing. In April 2020, Magenta announced the promotion of John Davis Jr., M.D., M.P.H., M.S. to Head of Research and Development and Chief Medical Officer.

COVID-19-related operational changes. Magenta has taken important steps to help ensure the safety of employees and their families and to reduce the spread of COVID-19 in the Cambridge community. In early March, Magenta created an internal, cross-functional COVID-19 response team, focused on employee safety and business continuity, to monitor closely the evolving situation and advise on the Company’s response. Magenta has established a work-from-home policy for all employees, other than those performing or supporting business-critical laboratory-based experiments, such as certain members of the Company’s laboratory and facilities staff. For those employees, Magenta has implemented stringent safety measures designed to comply with applicable federal, state and local guidelines instituted in response to the COVID-19 pandemic. Magenta has also maintained frequent communication with its partners and clinical sites as the COVID-19 situation has progressed.

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2020, were $130.4 million, compared to $145.7 million on December 31, 2019. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the first quarter of 2022.

Research and Development Expenses: Research and development expenses were $14.0 million in the first quarter of 2020, compared to $10.5 million in the first quarter of 2019. The increase was driven primarily by investments in manufacturing related to our conditioning programs and MGTA-456, increases in personnel to support the Company’s operations as a clinical-stage company and certain clinical activities for MGTA-145.

General and Administrative Expenses: General and administrative expenses were $7.3 million for the first quarter of 2020, compared to $5.8 million for the first quarter of 2019. The increase was primarily due to an increase in personnel and facilities associated with the growth of the Company, in addition to consulting work related to pre-commercialization activities.

Net Loss: Net loss was $20.0 million for the first quarter of 2020, compared to net loss of $14.8 million for the first quarter of 2019.

Conference Call Details:

To access the call, please reference the dial-in details below. In addition, a live webcast will be available, and a playback of the call will be available on the Magenta Therapeutics website at View Source for 90 days following the call.

Kura Oncology to Present at BofA Securities Virtual Health Care Conference 2020

On May 7, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation at the BofA Securities Virtual Healthcare Conference 2020 (Press release, Kura Oncology, MAY 7, 2020, View Source [SID1234557314]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Tuesday, May 12, 2020 at 3:40 p.m. ET / 12:40 p.m. PT. The virtual conference will be held from May 12-14, 2020.

A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

Selecta Biosciences Reports First Quarter 2020 Financial Results

On May 7, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform, ImmTOR, reported financial results for the first quarter ended March 31, 2020 (Press release, Selecta Biosciences, MAY 7, 2020, View Source [SID1234557313]).

"To date, Selecta has been able to navigate many of the challenges presented by the COVID-19 pandemic, and as such, the ongoing COMPARE clinical trial of SEL-212 in chronic refractory gout is still on schedule, and we continue to expect to announce topline data in the third quarter of this year. However, we continue to recognize the inherent unpredictability of this ongoing situation. During this time, we have made the health and safety of our patients and healthcare providers the top priority, and we continue to work with our CRO and clinical sites to ensure that any risk posed to a patient or provider coming in for visits is properly mitigated," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We have also continued to advance our operations in other critical areas, including preparations for the commencement of the Phase 3 trial of SEL-212, and collaborating with AskBio to advance our gene therapy program. We remain on track to enter the clinic under this collaboration by the end of the year."

Recent Highlights and Anticipated Upcoming Milestones:

Topline Results from COMPARE Clinical Trial Expected in the Third Quarter of 2020: The head-to-head COMPARE study of Selecta’s lead product candidate, SEL-212 (ImmTOR + pegadricase), vs. pegloticase is expected to readout on schedule, as the Company continues to work closely with the CRO and clinical sites to monitor patient follow-up in light of the COVID-19 pandemic. The trial is evaluating a once-monthly dose of SEL-212 compared to biweekly doses of pegloticase, with the primary endpoint of the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months. The trial completed enrollment in December 2019, and as of April 2020, half of the patients had completed the study and all patients had reached three months of treatment.

Gene Therapy Program Expected to Enter the Clinic by the End of 2020: Selecta and its partner AskBio are jointly developing a broad portfolio of next-generation AAV gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients, which could represent a significant advancement in the gene therapy field. Selecta and AskBio anticipate entering the clinic by the end of 2020. Additionally, Selecta intends to advance its proprietary program in Ornithine Transcarbamylase (OTC) deficiency.
First Quarter 2020 Financial Results:

Cash Position: Selecta had $74.3 million in cash, cash equivalents, and restricted cash as of March 31, 2020, which compares to cash, cash equivalents, and restricted cash of $91.6 million as of December 31, 2019. Selecta believes its available cash, cash equivalents, and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2021.

Net cash used in operating activities was $11.7 million for the first quarter of 2020, as compared to $20.2 million for the same period in 2019.

Research and Development Expenses: Research and development expenses for the first quarter 2020 were $14.7 million, which compares with $7.4 million for the same period in 2019. The increase in costs was primarily the result of expenses incurred for our Phase 2 COMPARE trial for SEL-212 and for our gene therapy program in collaboration with AskBio.

General and Administrative Expenses: General and administrative expenses for the first quarter 2020 were $4.1 million, which compares with $4.5 million for the same period in 2019. The reduction in costs was the result of reduced salaries, consulting and professional fees offset by increased stock compensation expense.

Net Loss: For the first quarter 2020, Selecta reported a net loss of $19.6 million, or $0.21 per share, compared to a net loss of $12.1 million, or $0.31 per share for the same period in 2019.
Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s first quarter 2020 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10138607. Investors and the public can access the live and archived webcast of this call via the Investors & Media section of the company’s website, www.selectabio.com

MEI Pharma Reports Fiscal Third-Quarter 2020 Results and Recent Corporate Highlights

On May 7, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its third quarter ended March 31, 2020 and highlighted recent corporate progress (Press release, MEI Pharma, MAY 7, 2020, View Source [SID1234557312]).

"Entering our fiscal fourth quarter, MEI is well positioned as we continue progress across our business, as highlighted by the recent grant of Fast Track designation by FDA for ME-401 and our newly announced global alliance with Kyowa Kirin," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "These key achievements advance our efforts to optimize ME-401 to benefit patients across multiple B-cell malignancies inside and outside the U.S. and, importantly, the $100 million upfront payment from Kyowa Kirin helps extend our cash runway through at least 2023, including the ramp-up of MEI’s commercial activities and the potential launch of ME-401 in the U.S."

Dr. Gold continued: "With respect to the COVID-19 pandemic, all companies conducting clinical trials are facing a unique and challenging situation, and I’d like to thank all health care workers and other essential workers on the frontlines that are caring for the sick and keeping our society functioning. MEI will continue to be proactive in order to minimize the impact to our business, particularly the ongoing ME-401 TIDAL study. While the situation remains fluid, we will continue to focus on keeping the impact on TIDAL modest as we remain in close contact with all our sites to maintain patients on study and keep enrollment ongoing, even if at a somewhat reduced rate."

Recent Highlights

In April 2020, the Company entered a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401.
MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S.
MEI to book U.S. sales on 50-50 profit and cost sharing.
$100 million in an upfront cash payment to MEI.
$582.5 million in potential development, regulatory and commercial milestones
Kyowa Kirin obtains exclusive commercialization rights ex-U.S.
MEI to receive escalating tiered royalty payments from mid-teens on ex-U.S. sales.
In April 2020, Cheryl L. Cohen, former chief commercial officer of Medivation, Inc. and a product launch and commercialization veteran with over 25 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
In March 2020, the Company was granted Fast Track designation by the U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Fiscal Third-Quarter Fiscal Year 2020 Financial Results

As of March 31, 2020, MEI had $92.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Giving effect to the KKC Agreement, our cash, cash equivalents and short-term investments would have been $192.8 million.
For the three months ended March 31, 2020, cash used in operations was $10.3 million, compared to $11.3 million for the same period in 2019. For the nine months ending March 31, 2020, cash used in operations was $34.9 million, compared to $31.4 million for 2019. The increase primarily relates to costs associated with our clinical development programs.
Research and development expenses were $9.0 million for the quarter ended March 31, 2020, compared to $9.1 million for 2019. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401, offset by increased clinical trial costs for the ME-401 TIDAL study and increased personnel and legal patent costs.
General and administrative expenses were $3.9 million for the quarter ended March 31, 2020, compared to $3.6 million for 2019. The increase primarily relates to increased headcount to support our activities.
Revenue was $1.2 million for the quarter ended March 31, 2020, compared to revenue of $1.2 million for the same period in 2019. Revenue resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin Japan License Agreements.
Net loss was $4.3 million, or $0.04 per share, for the quarter ended March 31, 2020, compared to net loss of $17.4 million, or $0.24 per share for the same period in 2019. Net loss decreased primarily as a result of a non-cash gain in the current quarter and a non-cash expense in the prior quarter related to changes in the fair value of the warrant liability associated with the May 2018 financing. The Company had 105,998,677 shares of common stock outstanding as of March 31, 2020, compared with 71,280,660 shares as of March 31, 2019.
The adjusted net loss for the quarter ended March 31, 2020, excluding a non-cash gain related to changes in the fair value of the warrants (a non-GAAP measure), was $12.1 million, compared to an adjusted net loss of $12.2 million for 2019.

BAUSCH HEALTH COMPANIES INC. ANNOUNCES FIRST-QUARTER 2020 RESULTS

On May 7, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its first-quarter 2020 financial results (Press release, Bausch Health, MAY 7, 2020, View Source [SID1234557311]).

"As the COVID-19 pandemic began, our priority was to make sure that our employees were safe and that we took the necessary measures to protect our supply chain operations, which have enabled us to continue to fulfill our mission of improving people’s lives with our health care products," said Joseph C. Papa, chairman and CEO, Bausch Health. "With these measures in place, we expanded our focus to also support global health care systems, frontline health care workers and the patients in their care, including advancing the science to help find solutions for COVID-19, donating medicines and health care products to assist in the fight against the virus and reinforcing our commitment to patient access."

"While the COVID-19 pandemic has presented significant challenges to our business, Bausch Health has a global, diversified and durable business model, and we believe the Company is well-positioned to return to growth after the impact of the pandemic fades," continued Mr. Papa.
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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.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

The Bausch + Lomb/International segment comprised approximately 55% of the Company’s reported revenue in the first quarter of 2020

Reported revenue in the Bausch + Lomb/International segment was flat compared to the first quarter of 2019; revenue in this segment grew organically1,2 by 2% compared to the first quarter of 2019, driven by organic growth1,2 in the Global Consumer and International Rx business units

Delivered 14th consecutive quarter of organic revenue growth2

Published pivotal Phase 3 data in Ophthalmology for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension), an investigational therapy with a proposed indication of treatment of macular edema associated with uveitis

Launched expanded parameters for Biotrue ONEday for Astigmatism daily disposable contact lenses

Received U.S. 510(k) filing acceptance from the U.S. Food and Drug Administration for the Company’s innovative daily disposable silicone hydrogel contact lenses

The Salix segment comprised approximately 24% of the Company’s reported revenue in the first quarter of 2020

Reported revenue in the Salix segment increased by 7% compared to the first quarter of 2019; revenue in this segment grew organically1,2 by 4% compared to the first quarter of 2019

Reported revenue of XIFAXAN (rifaximin) increased by 23% compared to the first quarter of 2019

Announced topline results from a Phase 2 study evaluating an investigative soluble solid dispersion (SSD) formulation of immediate release (IR) rifaximin in combination with the current standard of care therapy for the treatment of Overt Hepatic Encephalopathy. In the study, the 40 mg BID of rifaximin SSD IR plus standard of care therapy arm met its primary endpoint with statistically significantly superior results compared to the placebo plus standard of care therapy arm

The Ortho Dermatologics segment comprised approximately 7% of the Company’s reported revenue in the first quarter of 2020

Reported revenue in the Global Solta business unit grew by 34% compared to the first quarter of 2019, driven by continued strong demand of Thermage FLX following launches in the Asia Pacific region

Published results from two pivotal Phase 3 studies for ARAZLO (tazarotene) Lotion, 0.045%, in the Journal of Drugs in Dermatology

Strategic Capital Allocation and Debt Management

Increased Research and Development (R&D) by approximately 4%, or $5 million, compared to the first quarter of 2019

Repaid debt by approximately $220 million in the first quarter of 2020 with cash generated from operations

Bausch Health has no mandatory amortization payments or debt maturities until 2022

Response to COVID-19 Pandemic
When the COVID-19 pandemic emerged, Bausch Health acted quickly to implement guidelines, business continuity plans and workstreams that have enabled the Company to ensure the health and well-being of its employees while remaining focused on supporting customers and patients around the world.

Bausch Health management implemented actions to protect the health and safety of its employees, including taking every precaution to ensure that those employees who cannot work remotely, such as manufacturing employees, are working in environments that are as safe as possible

In regions of the world where in-person sales efforts are not viable, sales teams are supporting health care professionals virtually to continue to meet the needs of customers and their patients

The Company has worked to maintain an uninterrupted availability of its health care products by developing additional site-level biosecurity procedures. Supply chain and manufacturing facilities are operational, and to date, Bausch Health has not had any material COVID-19 related supply disruptions

Bausch Health’s R&D organization quickly worked with health authorities and investigators to protect trial participants and personnel involved in its R&D programs. Clinical trials that started prior to governmental shutdowns remain enrolled and existing patients are progressing, while new patient enrollments in clinical trials have been temporarily paused due to most trial sites not being able to accept new patients

Bausch Health also sought several opportunities to support the institutions, patients and health care providers fighting the COVID-19 pandemic.

The Company is pursuing research to determine if its products may offer valuable treatment options, including:

Initiating a clinical trial program in Canada evaluating an investigational use of nebulized antiviral VIRAZOLE (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19

Working toward investigative trials in the United States to evaluate XIFAXAN in combination therapy to potentially address the symptoms of gastrointestinal distress and pulmonary compromise associated with COVID-19 infection. If the trials demonstrate XIFAXAN is successful in resolving these symptoms or reducing the duration of COVID-19, the Bausch Foundation will donate XIFAXAN to various hospitals

Ramped up manufacturing of chloroquine and azithromycin and donated these products to local hospitals in Italy and Spain

Along with the Bausch Foundation, Bausch Health has provided needed medical supplies, including:

Making available for donation nebulized VIRAZOLE for compassionate use in Italian hospitals

Donating ARTELAC Splash eye drops to local hospitals in Spain to reduce eye irritation and risk of eye infection by alleviating possible symptoms of dry eye among health care providers while wearing protective gear

Converting production lines in China and Canada to produce hand sanitizer intended for donation to health care providers, first responders and volunteers

Donating Biotrue ONEday contact lenses to health care providers in Wuhan, China to alleviate reported fogging of eyeglasses while wearing protective gear

The Bausch Health Patient Assistance Program continues to ensure that eligible U.S. patients in need who lack health insurance coverage for certain Bausch Health prescription medicines are able to access their medicines and has increased its efforts to work with patients and physicians’ offices to ensure patients have uninterrupted access to their medicines

First-Quarter 2020 Revenue Performance
Total reported revenues were $2.012 billion for the first quarter of 2020, as compared to $2.016 billion in the first quarter of 2019, a decrease of $4 million. Revenue was negatively impacted by approximately $35 million in the first quarter of 2020 due to the COVID-19 pandemic. Excluding the unfavorable impact of foreign exchange of $18 million, the impact of a 2019 acquisition of $13 million

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.114 billion for the first quarter of 2020, as compared to $1.118 billion for the first quarter of 2019, a decrease of $4 million. Excluding the impact of foreign exchange of $17 million and the impact of divestitures and discontinuations of $7 million, the Bausch + Lomb/International segment grew organically1,2 by approximately 2% compared to the first quarter of 2019 due to growth in the Global Consumer and International Rx business units.

Salix Segment
Salix segment revenues were $477 million for the first quarter of 2020, as compared to $445 million for the first quarter of 2019, an increase of $32 million, or 7%. Adjusting for the impact of a 2019 acquisition of $13 million on revenues, the segment grew organically1,2 by approximately 4% compared to the first quarter of 2019. The increase was primarily driven by XIFAXAN, which grew 23% compared to the first quarter of 2019, and was partially offset by the loss of exclusivity of products in the segment, primarily APRISO (mesalamine), which negatively impacted revenues by $40 million.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $133 million for the first quarter of 2020, as compared to $138 million for the first quarter of 2019, a decrease of $5 million, or 4%. The decline was due to lower volumes primarily driven by the loss of exclusivity of products in the segment, primarily SOLODYN (minocycline HCl), ZOVIRAX (acyclovir) Cream, 5%, and ELIDEL (pimecrolimus) Cream, 1%, which negatively impacted revenues by $15 million, and was partially offset by higher revenues in the Global Solta business unit.

Diversified Products Segment
Diversified Products segment revenues were $288 million for the first quarter of 2020, as compared to $315 million for the first quarter of 2019, a decrease of $27 million, or 9%. The decrease was primarily attributable to the previously reported loss of exclusivity for a basket of products.
Operating Results
Operating income was $248 million for the first quarter of 2020, as compared to operating income of $287 million for the first quarter of 2019, a decrease of $39 million. The decrease in operating income was primarily driven by increases in selling, general and administrative expenses (SG&A), acquisition-related contingent consideration and charges for litigation and other matters included in other expense (income), net partially offset by a decrease in amortization of intangible assets.

Net Loss
Net loss for the first quarter of 2020 was $152 million, as compared to net loss of $52 million for the same period in 2019, an unfavorable change of $100 million. The change was primarily driven by decreases in the benefit from income taxes and by income from operations, as discussed above.

Adjusted net income (non-GAAP)1 for the first quarter of 2020 was $316 million, as compared to $358 million for the first quarter of 2019, a decrease of $42 million, or 12%.

Cash Generated from Operations
The Company generated $261 million of cash from operations in the first quarter of 2020, as compared to $413 million in the first quarter of 2019, a decrease of $152 million, or 37%. The decrease in cash from operations was primarily attributed to an increase in working capital4, timing of interest payments and a licensing agreement.

EPS
GAAP Earnings Per Share (EPS) Diluted for the first quarter of 2020 was ($0.43), as compared to ($0.15) for the first quarter of 2019.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $813 million for the first quarter of 2020, as compared to $851 million for the first quarter of 2019, a decrease of $38 million, or 4%. The decrease was primarily due to increased SG&A expenses and loss of exclusivity for certain products, coupled with the unfavorable impact of transactional foreign exchange.

2020 Financial Outlook
Bausch Health lowered its revenue and Adjusted EBITDA (non-GAAP) guidance ranges for the full year of 2020, primarily due to the actual and anticipated impacts of the COVID-19 pandemic:

Lowered full-year revenue range from $8.65 – $8.85 billion to $7.80 – $8.20 billion

Lowered full-year Adjusted EBITDA (non-GAAP) range from $3.50 – $3.65 billion to $3.15 – $3.35 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 and have also resulted in lower expectations regarding cash generated from operations and the amount of cash that is available for use in the reduction of debt and for bolt-on acquisitions for the current year. Furthermore, the COVID-19 pandemic and its impacts also triggered the Company’s reduction of the ranges for its targeted three-year compound annual growth rate of revenue and Adjusted EBITDA (non-GAAP), which have been reduced from 4%-6% to 3%-5% with respect to revenue growth and from 5%-8% to 4%-7% for Adjusted EBITDA (non-GAAP) growth. 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 $1.923 billion5 at March 31, 2020

The Company’s availability under the Revolving Credit Facility was $1.057 billion at March 31, 2020

Basic weighted average shares outstanding for the quarter were 353.4 million shares. Diluted weighted average shares outstanding for the quarter were 358.6 million shares6