On August 6, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the second quarter ended June 30, 2020, and provided a corporate update (Press release, BioCryst Pharmaceuticals, AUG 6, 2020, View Source [SID1234563129]).

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"BioCryst is currently in an exciting transformation from a company primarily focused on R&D to one that is about to launch its first oral drug to patients with HAE (ORLADEYO) this year, generating meaningful revenue starting next year, with global peak sales potential of greater than half a billion dollars. In parallel, we plan to fill our pipeline with a single molecule, BCX9930, by investing to accelerate this program across multiple rare disease indications based on the proof of concept data we have," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We expect to end the year with ORLADEYO approved in the U.S. and Japan, additional data at 200 mg and 400 mg with BCX9930 in PNH patients, and clinical data from galidesivir in COVID-19 patients," Stonehouse added.

Program Updates and Key Milestones

Hereditary Angioedema (HAE) Program – ORLADEYO: Oral, once-daily treatment for prevention of HAE attacks
BioCryst expects three regulatory approvals for ORLADEYO in Q4 2020 and early 2021.

The U.S. Food and Drug Administration (FDA) is reviewing a new drug application for ORLADEYO and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA).

In Japan, ORLADEYO is being reviewed under Sakigake designation. The Pharmaceutical and Medical Devices Agency (PMDA) has confirmed their regulatory review schedule and the company expects an approval decision in December 2020.

On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for ORLADEYO and begun its formal review of the MAA under the centralized procedure. The company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) within approximately 12 months from MAA validation.

BioCryst has completed significant preparations to support the launch of ORLADEYO in the U.S.

The company has attracted an accomplished U.S. rare disease sales team, which averages 20 years in pharmaceutical sales and nearly a decade of rare disease experience.

The company is well-positioned in terms of product supply and inventory on-hand to support the launch and anticipated global demand for ORLADEYO.

On June 9, 2020, the company announced that it had established an expanded access program with ORLADEYO for patients with HAE in the United States. Through this program, physicians may be able to request ORLADEYO for HAE patients who do not have access to the product through a clinical trial.

On June 6, at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress, the company presented new data highlighting the burden of therapy faced by HAE patients taking currently available injectable prophylactic medication. Patients taking oral, once daily ORLADEYO experienced sustained decreases in their attack frequency and improvements in quality of life scores over 48 weeks. ORLADEYO was also safe and generally well-tolerated over 48 weeks in both the APeX-2 and APeX-S clinical trials.
"Our ongoing dialogue and research with HAE patients and physicians continue to reinforce their strong demand for an oral, once-daily medicine that is safe and provides the significant and sustained attack reduction we are seeing with ORLADEYO in our clinical program. Nearly half of patients in our APeX-2 and APeX-S trials have prior experience with injectable or infused therapies and most have chosen to remain on ORLADEYO," said Charlie Gayer, chief commercial officer of BioCryst.

Complement Oral Factor D Inhibitor Program – BCX9930

On August 3, 2020, the company announced that the FDA has granted Fast Track designation for BCX9930 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). According to the FDA, the purpose of the Fast Track designation is to get important new drugs to the patient earlier by facilitating the development, and expediting the review of, drugs to treat serious conditions and fill an unmet medical need.

On May 6, 2020, the company reported proof of concept data for BCX9930 in three treatment-naïve PNH patients in the lowest dose cohort of 50 mg (14 days) and 100 mg (14 days) twice-daily. BCX9930 inhibited complement and was safe and generally well tolerated.

Based on the investigators’ assessment, three patients receiving 50 mg and 100 mg twice daily experienced clinical benefit, continued on therapy and are now receiving BCX9930 therapy at higher doses. An additional treatment-naïve PNH cohort, which starts at 200 mg (14 days) followed by 400 mg (14 days) twice-daily, has also begun enrollment. The company expects to report data from treatment-naïve PNH patients receiving 200 mg / 400 mg twice daily in Q3 2020.

The company plans to report data from PNH patients who are poor responders to C5 inhibitors receiving 200 mg / 400 mg twice daily by the end of 2020.

Based on the safety and proof-of-concept data generated to date in PNH patients, the company is working closely with key opinion leaders in hematology and nephrology to map the development strategy across a broad set of indications.
"We plan to meet with regulators later this year to confirm our advanced development plan for BCX9930 in PNH. Because the alternative pathway of complement is also directly related to several complement-mediated diseases, we plan to broaden and accelerate the BCX9930 program to patients in multiple disease areas as quickly as possible," said Dr. William Sheridan, chief medical officer of BioCryst.

Coronavirus Antiviral Program – Galidesivir (BCX4430)

In response to the COVID-19 pandemic, the company is conducting a randomized, double-blind, placebo-controlled clinical trial (NCT03891420) in Brazil to assess the safety, clinical impact and antiviral effects of galidesivir in COVID-19 patients. The company expects to provide information from Part 1 of this ongoing clinical trial by the end of Q3 2020.

The galidesivir program is being substantially funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA). The goal of the galidesivir clinical program is to evaluate clinical activity that would support additional government investment and advanced development of galidesivir, including additional drug supply.
Additional Updates

The company remains on track to report data in 2H 2020 from its ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects.
Second Quarter 2020 Financial Results

For the three months ended June 30, 2020, total revenues were $2.9 million, compared to $1.4 million in the second quarter of 2019. The increase was primarily due to an increase in collaboration revenue under U.S. government development contracts.

Research and development (R&D) expenses for the second quarter of 2020 were $27.5 million, similar to $27.7 million in the second quarter of 2019. During the second quarter of 2020, R&D spending increased on the company’s complement-mediated diseases and galidesivir programs, which was offset by a reduction in spend on the ORLADEYO program as the company approaches commercial launch.

Selling, general and administrative (SG&A) expenses for the second quarter of 2020 increased to $13.9 million, compared to SG&A expenses of $8.7 million in the second quarter of 2019. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of ORLADEYO in 2020.

Interest and other income were $2.8 million in the second quarter of 2020, compared to $0.5 million in the second quarter of 2019. The increase was primarily due to recognition of income from our arbitration proceedings.

Interest expense was $2.9 million in the second quarter of 2020, compared to $3.0 million in the second quarter of 2019.

Net loss for the second quarter of 2020 was $38.6 million, or $0.24 per share, compared to a net loss of $37.6 million, or $0.34 per share, for the second quarter of 2019.

Cash, cash equivalents and investments and restricted cash totaled $191.6 million at June 30, 2020, and reflect an increase from $137.8 million at December 31, 2019 and $114.6 million at March 31, 2020. Operating cash use for the second quarter of 2020 was $31.8 million.

Financial Outlook for 2020

With the additional capital raised in Q2 and the safety and proof-of concept data generated to-date with BCX9930 in PNH patients, the company is investing in accelerated development of BCX9930 and expects full year 2020 net operating cash use to be in the range of $150 to $165 million, and its operating expenses to be in the range of $180 to $195 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 5142479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 5142479.

On August 6, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported financial results for the second quarter of 2020 and provided a corporate update (Press release, Aldeyra Therapeutics, AUG 6, 2020, View Source [SID1234563128]).

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"We continue to make important progress in advancing a number of clinical-stage programs focused on the development of reproxalap and ADX-629, our first-in-class reactive aldehyde species (RASP) inhibitors," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Following a successful meeting with the US Food and Drug Administration (FDA) in June, we are on track to initiate clinical trials assessing levels of RASP, a pro-inflammatory mediator, in the tears of patients with dry eye disease. Clinical development of ADX-629, an orally available RASP inhibitor, in COVID-19, psoriasis, and atopic asthma is expected to begin during the second half of this year."

"We also have enhanced our financial flexibility with recent common stock sales to Perceptive Advisors and Avidity Partners, transactions that generated gross proceeds of approximately $19.5 million and completed our previously announced at-the-market offering program," Dr. Brady continued. "We now expect to be able to fund operations through 2022, including potential approvals for reproxalap in dry eye disease and allergic conjunctivitis."

Recent Highlights

Use of RASP as an Objective Sign for Treatment of Dry Eye Disease: In June 2020, Aldeyra announced agreement with the FDA for the use of RASP as an objective sign for the treatment of dry eye disease, marking the first new objective sign for the disease in more than a decade.

IND Submission for ADX-629: Aldeyra completed an Investigational New Drug (IND) submission under the FDA’s Coronavirus Accelerated Treatment Program to initiate a Phase 2 clinical trial of ADX-629 in patients with COVID-19.

Orphan Medicinal Product Designation for ADX-2191: The European Commission designated ADX-2191 as an orphan medicinal product for the treatment of retinal detachment. ADX-2191, a novel and proprietary intravitreal formulation of methotrexate, is being evaluated in the Phase 3 GUARD Trial for prevention of recurrent retinal detachment due to proliferative vitreoretinopathy (PVR), the leading cause of failure of retinal detachment surgery. Drugs that receive the orphan medicinal product designation in the European Union (EU) are entitled to protocol assistance, research funding, and, upon approval, 10 years of EU market exclusivity.

Clinical-Stage Pipeline Updates

Reproxalap – A Novel Topical Ocular RASP Inhibitor for the Treatment of Dry Eye Disease and Allergic Conjunctivitis: In the fourth quarter of this year, Aldeyra intends to initiate clinical testing to assess the activity of topical ocular reproxalap in reducing tear levels of RASP and other objective signs of dry eye disease, subject to finalization of trial design, RASP assay development, and potential disruptions due to the COVID-19 pandemic. In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020. NDA submission is expected by the end of 2021, assuming positive clinical trial results and regulatory review. Top-line results from the Phase 3 INVIGORATE allergen chamber trial, the second Phase 3 trial of reproxalap in allergic conjunctivitis, are expected in the first half of 2021.

ADX-629 – A Novel Orally Available RASP Inhibitor for the Treatment of Systemic Inflammatory Diseases: An IND for Phase 2 clinical testing of ADX-629 in patients with COVID-19 has been filed with the FDA. Additionally, in the fourth quarter of this year, the company expects to initiate Phase 2a clinical trials of ADX-629 in patients with psoriasis and atopic asthma.

ADX-2191 – An Intravitreal Methotrexate Injectable for Rare Proliferative Ocular Diseases: Aldeyra has filed for Orphan Drug Designation (ODD) with the FDA for ADX-2191 for the treatment of primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer that arises in the vitreous and retina. Additionally, an update on enrollment in the Phase 3 GUARD trial of ADX-2191 for the prevention of PVR, a rare but serious sight-threatening retinal disease with no approved treatment, is expected by the end of this year.

Financial Results for the Quarter Ended June 30, 2020

For the quarter ended June 30, 2020, Aldeyra reported a net loss of $7.5 million, compared with a net loss of $13.3 million for the quarter ended June 30, 2019. Net loss per share was $0.25 for the quarter ended June 30, 2020, compared with $0.49 for the same period in 2019. Losses have resulted from the costs of Aldeyra’s clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses were $4.9 million for the quarter ended June 30, 2020, compared with $10.7 million for the same period in 2019. The decrease of $5.8 million is primarily related to the decreases in clinical and preclinical development, manufacturing, and personnel costs.

General and administrative expenses were $2.2 million for the quarter ended June 30, 2020, compared with $3.1 million for the same period in 2019. The decrease of $0.9 million is due to decreases in personnel related costs, including stock-based compensation, and other miscellaneous administrative costs.

For the quarter ended June 30, 2020, total operating expenses were $7.1 million, compared with total operating expenses of $13.7 million for the same period in 2019.

As of June 30, 2020, cash, cash equivalents, and marketable securities were $66.2 million. Subsequent to June 30, 2020, $25.2 million in cash was received from at-the-market offering program sales to Perceptive Advisors, Avidity Partners, and other investors. Based on current operating plans, cash, cash equivalents, and marketable securities as of June 30, 2020, plus the additional at-the-market offering program proceeds, are expected to be sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals. Use of Aldeyra’s cash, cash equivalents, and marketable securities are also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial in PVR, and Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.

Conference Call & Webcast Information

Aldeyra will host a conference call today at 8:00 a.m. ET to discuss its second-quarter 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 9297174. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the investor relations page of the company’s corporate website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

ADX-1612 – A Protein Chaperome Inhibitor for Systemic Disease: Enrollment has been completed in the investigator-sponsored Phase 2 EUDARIO Trial of ADX-1612 in ovarian cancer. Regarding the ADX-1612 COVID-19 program, consistent with FDA feedback, additional preclinical antiviral testing of ADX-1612 against SARS-CoV-2, the virus that causes COVID-19, will be performed by the National Institute of Allergy and Infectious Diseases, which has accepted the company’s request to evaluate ADX-1612 in in vivo models. Aldeyra expects to provide an update on the ADX-1612 COVID-19 program by the end of 2020.

On August 6, 2020 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its second-quarter 2020 financial results (Press release, Bausch Health, AUG 6, 2020, View Source [SID1234563127]).

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"Since the COVID-19 pandemic began, our top priority has been to ensure our employees remain safe and that we have the necessary processes in place to protect our supply chain so that we can continue to provide access to our health care products to people around the world," said Joseph C. Papa, chairman and CEO, Bausch Health.

"The impact of the pandemic continues to cause uncertainty in markets globally. While our business recovery appears to be progressing more quickly in some geographies, such as the United States, other markets in Europe and Asia will take more time to return to pre-pandemic levels," continued Mr. Papa. "Given these variabilities, we are focused on driving market share for our key products, reaching customers in new ways and executing on our launches, such as the upcoming launch of BAUSCH + LOMB INFUSE SiHy daily contact lenses, while also optimizing our cost structure to protect the profitability of the Company."

Executing on Core Businesses and Advancing Pipeline
•The Bausch + Lomb/International segment comprised approximately 53% of the Company’s reported revenue in the second quarter of 2020
◦Reported revenue in the Bausch + Lomb/International segment decreased 27% compared to the second quarter of 2019; revenue in this segment decreased organically1,2 by 24% compared to the second quarter of 2019
◦Reported revenue for LUMIFY increased by 36% compared to the second quarter of 2019
◦Received 510(k) clearance from the U.S. Food and Drug Administration for BAUSCH + LOMB INFUSE daily disposable silicone hydrogel (SiHy daily) contact lenses

◦Launched the Company’s first Extended Depth of Focus intraocular lens (IOL), LuxSmart, and a new monofocal IOL, LuxGood, in Europe
◦Received approval for BAUSCH + LOMB ULTRA monthly silicone hydrogel contact lenses from the National Medical Products Administration in China
◦Entered into an exclusive licensing agreement with STADA Arzneimittel AG and its development partner, Xbrane Biopharma AB, to develop and commercialize a biosimilar candidate to Lucentis (ranibizumab) in the United States and Canada
•The Salix segment comprised approximately 24% of the Company’s reported revenue in the second quarter of 2020
◦Reported and organic1,2 revenue in the Salix segment decreased by 21% compared to the second quarter of 2019
◦Reported revenue for RELISTOR (methylnaltrexone bromide) increased by 8% compared to the second quarter of 2019
•The Ortho Dermatologics segment comprised approximately 7% of the Company’s reported revenue in the second quarter of 2020
◦Reported and organic1,2 revenue in the Ortho Dermatologics segment decreased by 5% compared to the second quarter of 2019
◦Reported revenues for the Thermage franchise and SILIQ (brodalumab) increased by 12% and 50%, respectively, compared to the second quarter of 2019
◦Launched ARAZLO (tazarotene) Lotion, 0.045%, in the United States
◦Received an expanded indication in the United States for JUBLIA (efinaconazole) Topical Solution, 10%, to treat patients as young as six years old

Debt Management
•Repaid debt by approximately $100 million in the second quarter of 2020 for a total of approximately $320 million in the first half of 2020 with cash generated from operations
•Refinanced $1.25 billion of 2022 Senior Secured Notes and prepaid $250 million of mandatory 2022 term loan amortization using net proceeds from newly issued $1.5 billion of 6.25% 2029 Senior Unsecured Notes and cash generated from operations
•Bausch Health has no debt maturities or mandatory amortization payments until 2023

Resolving Legacy Legal Matters
•Resolved the legacy investigation on July 31 by the U.S. Securities and Exchange Commission for $45 million regarding the Company’s former relationship with Philidor Rx Services, LLC and certain accounting practices and disclosures related to the 2014 and 2015 reporting periods. The Company neither denied nor admitted the charges.
•Agreed to resolve the Canadian securities class action litigation on August 4 for $94 million CAD (approximately $69 million3 USD), plus settlement administration costs, subject to court approval. The Company admits no liability and denies all allegations of wrongdoing whatsoever.

Continued Response to the COVID-19 Pandemic
Bausch Health continues to advance its relief and R&D efforts related to the COVID-19 pandemic, including the evaluation of existing medicines, such as VIRAZOLE (Ribavirin for Inhalation Solution, USP), in patients with COVID-19, as well as the donation of health care products and supplies through the Company and the Bausch Foundation. The Company has continued to execute on its business continuity plans to ensure the health and well-being of its employees while also remaining focused on supporting customers and patients around the world and maintaining an uninterrupted availability of its health care products.

Second-Quarter 2020 Revenue Performance
Total reported revenues were $1.664 billion for the second quarter of 2020, as compared to $2.152 billion in the second quarter of 2019, a decrease of $488 million, or 23%. Revenue was negatively impacted by approximately $500 million in the second quarter of 2020 primarily due to the impact of the COVID-19 pandemic. Excluding the unfavorable impact of foreign exchange of $27 million and the impact of divestitures and discontinuations of $4 million, revenue declined 21% organically1,2 compared to the second quarter of 2019.
Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $883 million for the second quarter of 2020, as compared to $1.208 billion for the second quarter of 2019, a decrease of $325 million, or 27%. Excluding the unfavorable impact of foreign exchange of $27 million and the impact of divestitures and discontinuations of $4 million, the Bausch + Lomb/International segment declined organically1,2 by approximately 24% compared to the second quarter of 2019 primarily due to the impact of the COVID-19 pandemic.

Salix Segment
Salix segment revenues were $404 million for the second quarter of 2020, as compared to $509 million for the second quarter of 2019, a decrease of $105 million, or 21%. The decrease was primarily due to the impact of the COVID-19 pandemic; the loss of exclusivity of products in the segment, primarily APRISO (mesalamine), which negatively impacted revenues by $39 million; and by sales of XIFAXAN (rifaximin), which declined by 12% compared to the second quarter of 2019 primarily due to the COVID-19 pandemic, including reduced channel inventories at the retail level.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $116 million for the second quarter of 2020, as compared to $122 million for the second quarter of 2019, a decrease of $6 million, or 5%. The decline in revenue was due to the impact of the COVID-19 pandemic.
Diversified Products Segment
Diversified Products segment revenues were $261 million for the second quarter of 2020, as compared to $313 million for the second quarter of 2019, a decrease of $52 million, or 17%. 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 loss was $27 million for the second quarter of 2020, as compared to operating income of $257 million for the second quarter of 2019, a decrease of $284 million. The decrease in operating results was primarily due to decreases in revenues and gross margins as a result of the COVID-19 pandemic and the accrual of legal reserves established for the resolution of certain legacy litigation matters, partially offset by decreases in selling, general and administrative (SG&A) expenses and the amortization of intangible assets.

Net Loss
Net loss was $326 million for the second quarter of 2020, as compared to net loss of $171 million for the second quarter of 2019, an unfavorable change of $155 million. The change was primarily driven by decreased operating results discussed above, partially offset by an increase in benefit from income taxes and a decrease in interest expense.

Adjusted net income (non-GAAP)1 for the second quarter of 2020 was $165 million, as compared to $372 million for the second quarter of 2019, a decrease of $207 million, or 56%.

Cash Generated from Operations
The Company generated $200 million of cash from operations in the second quarter of 2020, as compared to $339 million in the second quarter of 2019, a decrease of $139 million. The decrease in cash from operations was primarily attributed to the decreased operating results discussed above.

EPS
GAAP Earnings Per Share (EPS) Diluted for the second quarter of 2020 was ($0.92), as compared to ($0.49) for the second quarter of 2019.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $622 million for the second quarter of 2020, as compared to $880 million for the second quarter of 2019, a decrease of $258 million, or 29%. The decrease was primarily due to decreases in revenues and gross margins as a result of the impact of the COVID-19 pandemic, partially offset by decreases in SG&A expenses.
2020 Financial Outlook
Bausch Health tightened 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. These anticipated impacts assume that a potential resurgence of the virus in the second half of 2020 would not produce severe social restrictions put in place by governmental authorities (e.g., shelter at home, closure of non-essential businesses, deferral of elective medical procedures, etc.) and that global economies will recover as the COVID-19 pandemic runs its course and social restrictions are eased. Bausch Health’s guidance ranges are as follows:
•Narrowed full-year revenue range from $7.80 – $8.20 billion to $7.80 – $8.00 billion
•Narrowed full-year Adjusted EBITDA (non-GAAP) range from $3.15 – $3.35 billion to $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 $1.907 billion5 at June 30, 2020
•The Company’s availability under the Revolving Credit Facility was $1.131 billion at June 30, 2020
•Basic weighted average shares outstanding for the quarter were 355.3 million shares. Diluted weighted average shares outstanding for the quarter were 357.3 million shares6

On August 6, 2020 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the second quarter ended June 30, 2020 (Press release, AMAG Pharmaceuticals, AUG 6, 2020, View Source [SID1234563126]). The company reported total revenues for the second quarter of 2020 of $52.8 million, including revenue of $29.6 million from Feraheme (ferumoxytol injection) and revenue of $22.3 million from Makena (hydroxyprogesterone caproate injection). The company also reported an operating loss of $7.0 million and an adjusted EBITDA loss of $1.7 million in the second quarter of 2020.1

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"Amidst the unprecedented uncertainty that COVID-19 placed on the healthcare system and our economy, AMAG’s marketed therapeutics performed well in the second quarter due in part to our teams’ ability to adapt in a rapidly-changing environment," said Scott Myers, AMAG’s Chief Executive Officer. "Over the past three months, we have advanced the company’s strategic evolution by reaching important milestones that include a strategic, ex-US partnership with Norgine to further progress ciraparantag and strengthen our company’s ability to invest in our pipeline. We have also streamlined expenses by completing the divestment of Intrarosa and Vyleesi and making changes to our portfolio designed to further focus on programs with the highest potential to deliver innovative treatments for patients and unlock shareholder value."

"Strong execution across our portfolio throughout the COVID-19 pandemic allows us to reissue financial guidance that reflects the relative stability of Makena over the quarter and the momentum that Feraheme began to build in June, which saw record highs in monthly share and ex-factory volume," said Brian Piekos, Chief Financial Officer. "The guidance we are sharing today is designed to prioritize investments that will drive long-term growth while also putting us on track to return to positive adjusted EBITDA."

PORTFOLIO UPDATES
Ciraparantag (AMAG-977) – As previously announced, AMAG has completed an exclusive licensing agreement with Norgine, a leading European specialist pharmaceutical company, to develop and commercialize ciraparantag in Europe, Australia and New Zealand. Through this agreement, AMAG has received a total of $30 million in upfront consideration and could receive up to $260 million in future contingent development and commercial milestones4 together with escalating double-digit royalties. Additionally, Norgine has committed to contribute one-third of the costs of the Phase 3 clinical program, which would be conducted by AMAG to support regulatory approval of ciraparantag by the U.S. Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare Products Regulatory Agency. AMAG will continue to oversee the Phase 3 clinical program, while working closely with Norgine to develop and execute a global development strategy. The company believes this partnership will unlock value in ciraparantag and further strengthen AMAG’s ability to continue investing in innovative therapies that address urgent unmet medical needs.

On July 12, AMAG presented a poster of data titled "Efficacy and Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in Healthy Adults" at the 2020 International Society on Thrombosis and Haemostatis (ISTH) virtual annual meeting. This presentation shared data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT).

AMAG-423 – The AMAG-423 Phase 2b/3a study was designed to explore a potential treatment for severe preeclampsia, a serious medical condition that impacts about 50,000 women in the US each year. As previously disclosed, the small population of eligible patients made the study difficult to enroll. The COVID-19 pandemic has led to a global pause for various clinical research projects across therapeutic areas, including the AMAG-423 Phase 2b/3a study. In light of these extended and ongoing delays to study completion, AMAG decided to conduct an interim analysis with data from 55 subjects to validate original study assumptions that were based on the 51-subject proof-of-concept DEEP study completed in 2007. In order to continue keeping AMAG blinded to study treatment assignments, the independent Data and Safety Monitoring Board (DSMB) was tasked with conducting the interim analysis.

Following this interim analysis, the DSMB provided a unanimous recommendation to stop the study, based upon the low likelihood that future enrollment would demonstrate a benefit of AMAG-423 in women with severe preeclampsia. Importantly, there were no safety concerns raised during this study. AMAG has accepted the DSMB’s recommendation to stop the study and is currently focused on ensuring an appropriate closeout of the study in partnership with investigators and other relevant stakeholders.

Divestiture of Intrarosa and Vyleesi – As previously announced, AMAG has completed the divestment of Intrarosa and Vyleesi which reduces operating expenses and allows the company to focus on optimizing its marketed assets and developing its innovative pipeline.

CORPORATE UPDATES
Leadership Appointments – The company has appointed Brian Piekos as its Chief Financial Officer, effective as of August 13, 2020. Mr. Piekos has served as interim CFO since June 2020 after holding several senior management positions since joining AMAG in 2015.
SECOND QUARTER ENDED JUNE 30
Revenue
Second quarter revenue totaled $52.8 million, compared to $77.8 million for the same period in 2019. This decrease was due to the negative impact of COVID-19 and the October 2019 unfavorable FDA Advisory Committee recommendation on Makena.
•Feraheme achieved second quarter revenue of $29.6 million, a decrease of 30 percent over the same period last year. Feraheme’s average quarterly market share was 17.3 percent in the second quarter of 2020, compared to 17.2 percent in the second quarter of 2019.
•Makena second quarter revenue totaled $22.3 million, a decrease of 27 percent over the same period last year. Makena’s average quarterly market share was 66 percent in the second quarter of 2020, compared to 63 percent in the second quarter of 2019.

Operating Expenses
Total costs and expenses decreased by $134.2 million to $59.8 million in the second quarter of 2020, as compared to the second quarter of 2019.
•Cost of products sales in the second quarter of 2020 decreased by $6.1 million, as compared with the second quarter of last year. Direct cost of product sales for the three months ended June 30, 2019 included a $4.8 million one-time inventory write-down related to the Makena IM product. Excluding this one-time inventory write-down, direct cost of product sales declined in the second quarter of 2020 due to reduced Feraheme and Makena sales and the divestment of Intrarosa.
•Research and development (R&D) expenses totaled $8.3 million, compared to $15.0 million in the first quarter of last year. This decrease was primarily related to lower costs for Vyleesi following FDA approval in 2019 and COVID-19 related delays in clinical trials.
•Selling, general and administrative (SG&A) expenses decreased by approximately $37.8 million, or 49 percent, in the second quarter of 2020, compared to the same period in 2019. This decrease was primarily due to decreases in marketing spend related to women’s health assets and reduced compensation-related costs as a result of the May 2020 restructuring.
Operating Loss and Adjusted EBITDA
•The company reported an operating loss of $7.0 million in the second quarter of 2020, compared to an operating loss of $116.2 million in the same period last year.
•The company reported a loss in adjusted EBITDA of $1.7 million in the second quarter of 2020, compared to a loss in adjusted EBITDA of $24.7 million in the same period last year.
The financial figures and statements referenced herein have been adjusted to correct immaterial errors in Makena revenue in the historical periods 2016 through the first quarter of 2020; in aggregate, Makena revenue is reduced by $6.3 million over the four-year period. This error was identified by the company during the second quarter of 2020 and relates to the timely accrual of certain governmental rebates. The company and our independent auditors are still reviewing the prior period financial statements and the potential impact on our internal controls over financial reporting for the periods. Therefore, the financials set forth in this release are preliminary and may be updated in the company’s quarterly report on Form 10Q for the quarter ended June 30, 2020. As a result, investors are cautioned not to place undue reliance on these financial statements.

CONFERENCE CALL AND WEBCAST ACCESS
AMAG Pharmaceuticals, Inc. will host a conference call and webcast today at 8:00 a.m. ET to discuss the company’s second quarter 2020 financial results and recent business updates.

DIAL-IN NUMBERS
U.S./Canada Dial-in Number: (877) 412-6083
International Dial-in Number: (702) 495-1202
Conference ID: 4548238

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 4548238

A telephone replay will be available from approximately 11:00 a.m. ET on August 6, 2020 through midnight on August 20, 2020

The webcast with slides will be accessible through the Investors section of the company’s website at www.amagpharma.com. A replay of the webcast will be archived on the website for 30 days.

On August 6, 2020 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases,reported financial results for its fiscal 2020 third quarter (Press release, Anavex Life Sciences, AUG 6, 2020, View Source [SID1234563125]).

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"It is an accomplishment having three ongoing clinical studies in Rett syndrome in progress with ANAVEX2-73 (blarcamesine) and we expect respective clinical trial results to be reported as we progress," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "It is important to point out that all clinical studies with ANAVEX2-73 (blarcamesine), including the ongoing Alzheimer’s disease Phase 2b/3 trial and Parkinson’s disease dementia Phase 2 study, which read out is upcoming, includes the entire genome and exome sequencing, opens the possibility of using big data-driven unbiased genome-wide patient analysis, hence, maintaining the focus on Precision Medicine for neurological disorders."

Program Updates:

Yesterday Anavex announced it has received compassionate use Special Access Scheme (SAS) approval for Alzheimer’s disease patients continued treatment with ANAVEX2-73 (blarcamesine) by the Australian Government Department of Health – Therapeutic Goods Administration (TGA).
In June 2020, Anavex announced it has received Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) as well as a ‘No Objection Letter’ from Health Canada to expand the footprint of the international Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX2-73-AD-004) of ANAVEX2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into the UK and Canada, respectively.
In June 2020, Anavex announced it exceeded by 50% its enrollment target for the ANAVEX2-73 (blarcamesine) U.S. Phase 2 study in Rett syndrome. The Company expects to announce topline results from this study in calendar Q4 2020.
In July 2020, Anavex announced that the first pediatric patient was dosed in the Phase 2/3 ANAVEX2-73-RS-003 EXCELLENCE clinical trial for the treatment of Rett syndrome with ANAVEX2-73 (blarcamesine).
In July 2020, Anavex announced the enrollment of the first participant in a Phase 1 clinical trial of ANAVEX3-71 (AF710B), an orally-administered small molecule targeting sigma-1 and M1 muscarinic receptors that is designed to be beneficial for neurodegenerative diseases, with topline data anticipated in the first half of 2021.
Financial Highlights:

Cash and cash equivalents of $27.6 million at June 30, 2020, compared to $22.2 million at fiscal year ended September 30, 2019.
Research and development expenses of $6.7 million for the quarter, compared to $5.8 million in the comparable quarter in 2019.
General and administrative expenses of $1.4 million for the quarter as well as for the comparable quarter in 2019.
Net loss of $6.5 million, or $0.11 per share for the quarter, compared to net loss of $6.5 million, or $0.13 per share in the comparable quarter of 2019.
The financial information for the fiscal quarter ended June 30, 2020 should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

Anavex will host a conference call and webcast today at 11:00 a.m. ET.

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 901-2585 and international callers should dial 1 (404) 835-7099. Please use confirmation number 49865428, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.