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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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.

On August 6, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, reported that it will hold its fiscal fourth-quarter 2020 sales and earnings conference call with investors and analysts at 4:30 p.m. EDT on Thursday, August 13, 2020 (Press release, Myriad Genetics, AUG 6, 2020, View Source [SID1234563124]). During the call, R. Bryan Riggsbee, interim president and CEO and chief financial officer, and Scott Gleason, senior vice president of Investor Relations and Corporate Strategy, will provide an overview of Myriad’s financial performance for the fiscal fourth-quarter and provide a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To listen to the earnings call, interested parties in the United States may dial 1-800-381-7839 or +1-212-239-2905 for international callers. All callers will be asked to reference reservation number 21966478. The conference call also will be available through a live webcast and a slide presentation pertaining to the earnings call also will be available under the investor section of our website at www.myriad.com. A replay of the call will be available two hours after the end of the call for seven days and may be accessed by dialing 800-633-8284 within the United States or +1 402-977-9140 for international callers and entering reservation number 21966478.

On August 6, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported its financial and operational results for the second quarter ended June 30, 2020 (Press release, Sierra Oncology, AUG 6, 2020, View Source [SID1234563123]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We believe momelotinib, if approved, may provide an important treatment option for underserved myelofibrosis patients, in particular those with anemia and thrombocytopenia, and as such is well-positioned to generate significant value," said Dr. Stephen Dilly, President and CEO of Sierra Oncology. "During the second quarter, we continued to advance the MOMENTUM Phase 3 trial and are on track to deliver top-line results in the first half of 2022. In anticipation of these pivotal data, we are preparing for the regulatory submission process and the potential commercialization of momelotinib, and subsequent to the end of the quarter, we substantially strengthened our senior management team to support these activities."

"We made significant progress during the first half of 2020 operationalizing the global MOMENTUM Phase 3 trial and, while the potential impact of the COVID-19 pandemic continues to be uncertain, we are pleased with the current pace of enrollment" said Dr. Barbara Klencke, Chief Development Officer, Sierra Oncology. "During the EHA (Free EHA Whitepaper) virtual conference, two world-leading physicians in the treatment of myelofibrosis reported long-term data that continue to reinforce momelotinib’s differentiated durability, safety and efficacy profile. We plan to report updated analyses in late 2020 comparing the symptomatic benefits of momelotinib to ruxolitinib from the SIMPLIFY-1 Phase 3 trial that will further emphasize momelotinib’s differentiated and competitive profile."

"As the MOMENTUM trial ramps up, we’ve managed our resources prudently and continue to anticipate our current cash runway will extend beyond top-line data and into the second half of 2022, subject to the potential impact of COVID-19," said Mr. Sukhi Jagpal, Chief Financial Officer of Sierra Oncology. "In addition, our Series B warrants will expire on the 75th day following the announcement of top-line data and may only be exercised by paying the exercise price in cash, which would amount to approximately $34.0 million in proceeds to the Company if fully exercised. We are also starting to explore non-dilutive options that could provide additional capital to support our North American commercialization strategy."

Second Quarter Highlights:

Hosted an Analyst & Investor Call featuring a presentation by renowned myelofibrosis expert Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, who discussed momelotinib’s ability to address anemia and transfusion dependency, two critical unmet medical needs in treating patients with myelofibrosis.

Reported favorable Long-Term Safety and Dose Intensity data for momelotinib from more than 550 patients across the two previously conducted SIMPLIFY Phase 3 studies and their subsequent ongoing extended treatment periods, at the 25th EHA (Free EHA Whitepaper) Virtual Congress.

Professor Claire Harrison, Guy’s and St. Thomas’ NHS Foundation Trust, London, United Kingdom presented a poster on the long-term safety profile of momelotinib, which demonstrated a lack of emergent or cumulative toxicity with extended daily administration. More than 90 SIMPLIFY-1 and SIMPLIFY-2 patients continued to receive momelotinib for 3.5 years or longer. Patients treated with momelotinib experienced rapid and sustained increases in hemoglobin, in contrast to the significant decrease in hemoglobin for patients receiving ruxolitinib. Patients treated with momelotinib also experienced significantly higher mean platelet counts compared to those receiving ruxolitinib. Importantly, patients who switched from ruxolitinib to momelotinib also achieved a sustained improvement in hemoglobin in both studies, and platelets in SIMPLIFY-1.

Dr. Vikas Gupta, Princess Margaret Cancer Centre, Toronto, Canada, presented a poster highlighting the sustained dose intensity and prolonged clinical activity of momelotinib across the continuum of JAK inhibitor naïve and previously JAK inhibitor treated myelofibrosis patients. While the starting doses for ruxolitinib were often attenuated due to low platelets, further reductions in dose intensity were also commonly required for ruxolitinib. In contrast, momelotinib was initiated at full dose for all patients enrolled to the SIMPLIFY studies and high dose intensity was maintained in the majority over extended dosing durations. Patients who switched from ruxolitinib to momelotinib saw an immediate and sustained improvement in dose intensity.

The data from the two interrelated presentations suggest that the favorable effect on hemoglobin and platelets allows momelotinib to be initiated at high dose intensity and maintained at high dose intensity over extended durations while retaining a favorable long-term safety profile. Notably, some patients continue to receive momelotinib 10 years after enrolling in the initial momelotinib Phase 2 trials, while 90 Phase 3 SIMPLIFY patients who enrolled into those trials 4 to 6 years ago continue to receive momelotinib, suggesting that the dosing and safety profile contributes to momelotinib’s potential ability to provide sustained benefits over extended durations.

Second Quarter 2020 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $10.2 million for the three months ended June 30, 2020 compared to $11.7 million for the three months ended June 30, 2019. The decrease was primarily due to a $2.1 million decrease in clinical trial, third-party manufacturing, research and preclinical costs for SRA737, a $1.1 million decrease in personnel-related and allocated overhead costs, and a $0.9 million decrease in third-party manufacturing costs for momelotinib. These decreases were partially offset by a $2.6 million increase in clinical trial and development costs for momelotinib. Research and development expenses included non-cash stock-based compensation of $0.9 million and $1.2 million for the three months ended June 30, 2020 and 2019, respectively.

Research and development expenses were $21.8 million for the six months ended June 30, 2020, compared with $21.9 million for the six months ended June 30, 2019. The decrease was primarily due to a $5.2 million decrease in clinical trial, third-party manufacturing, research and preclinical costs for SRA737, a $2.1 million decrease in personnel-related and allocated overhead costs, and a $0.6 million decrease in third-party manufacturing costs for momelotinib. These decreases were offset by a $6.3 million increase in clinical trial and development costs for momelotinib, and a non-cash charge of $1.5 million pertaining to the change in fair value of an obligation to issue common stock and a warrant to Gilead Sciences, Inc. (Gilead), which were issued during the first quarter of 2020. Research and development expenses included non-cash stock-based compensation of $1.5 million and $2.4 million for the six months ended June 30, 2020 and 2019, respectively.

General and administrative expenses were $6.3 million for the three months ended June 30, 2020, compared to $3.5 million for the three months ended June 30, 2019. The increase was primarily due to a non-cash $2.2 million stock-based compensation charge and a $0.6 million severance charge pertaining to an executive resignation. General and administrative expenses included non-cash stock-based compensation of $2.7 million and $0.5 million for the three months ended June 30, 2020 and 2019, respectively.

General and administrative expenses were $10.8 million for the six months ended June 30, 2020, compared to $6.8 million for the six months ended June 30, 2019. The increase was primarily due to a $3.0 million increase in personnel-related and allocated overhead costs, including a non-cash $2.2 million stock-based compensation charge noted above and $1.0 million of severance charges, offset by a decrease of $0.2 million in other personnel-related and allocated overhead costs. There was also an increase of $1.0 million in professional fees, including pre-commercial planning costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $3.1 million and $1.0 million for the six months ended June 30, 2020 and 2019, respectively.

Other income (expense), net was $24,000 of other expense, net for the three months ended June 30, 2020, compared to $0.3 million of other income, net for the three months ended June 30, 2019. The difference was primarily attributable to a decrease in interest income due to lower interest rates. Other income (expense), net was $15.7 million of other expense, net for the six months ended June 30, 2020, compared to $0.7 million of other income, net for the six months ended June 30, 2019. The difference was primarily attributable to a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities which were reclassified to equity in January 2020.

For the three months ended June 30, 2020, Sierra incurred a GAAP net loss of $16.5 million compared to a GAAP net loss of $14.9 million for the months ended June 30, 2019. For the six months ended June 30, 2020, Sierra incurred a GAAP net loss of $48.4 million compared to a GAAP net loss of $27.9 million for the six months ended June 30, 2019. The GAAP net loss for the six months ended June 30, 2020 includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in other income (expense), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $12.8 million for the three months ended June 30, 2020, compared with a non-GAAP adjusted net loss of $13.1 million for the three months ended June 30, 2019. Non-GAAP adjusted net loss for the three months ended June 30, 2020 and 2019 excludes expenses related to stock-based compensation. For the six months ended June 30, 2020, Sierra incurred a non-GAAP adjusted net loss of $26.1 million compared to a non-GAAP adjusted net loss of $24.5 million for the six months ended June 30, 2019. Non-GAAP adjusted net loss for the six months ended June 30, 2020 excludes expenses related to the change in fair value of warrant liabilities, the change in fair value of the securities issuance obligation, and stock-based compensation. Non-GAAP adjusted net loss for the six months ended June 30, 2019 excludes expenses related to stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

Cash and cash equivalents totaled $123.2 million as of June 30, 2020, compared to $147.5 million as of December 31, 2019.

As of June 30, 2020, there were 10,395,732 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. There were 2,351,055 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.