Epizyme Announces Date of First Quarter 2021 Financial Results

On April 29, 2021 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that management will host a conference call and webcast to discuss its first quarter 2021 financial results and provide a business update on Thursday, May 6, 2021 at 7:30 a.m. ET (Press release, Epizyme, APR 29, 2021, View Source [SID1234578833]).

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To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 4139845. A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the call.

Sirnaomics Enters Partnership with Walvax Biotechnology to Co-Develop Its Antiviral RNAi Therapeutic Product Candidate STP702

On April 29, 2021 Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd., a subsidiary of Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer, fibrotic diseases and viral infections, reported that the company has entered into a partnership agreement with Walvax Biotechnology (Walvax) for the co-development of its anti-influenza siRNA therapeutic product candidate STP702 (Press release, Sirnaomics, APR 29, 2021, View Source [SID1234578846]). Sirnaomics will out-license to Walvax the exclusive development and commercialization rights for territories including mainland China, Taiwan, Hong Kong and Macao. Based on the agreement, the company will receive an initial payment of ~US$6.4 million for this asset, with additional milestone payments and royalty sharing based on product sales.

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While the medical and scientific communities are continuing the fight against the Covid-19 pandemic, there needs to be continued attention towards other viruses, such as Influenza, which cause severe epidemics worldwide. Along with its resistant strains, new pathogenic viruses continue to be discovered, creating an ongoing need for new anti-influenza treatments. RNA interference (RNAi) is a cellular gene-silencing phenomenon, in which sequence-specific degradation of target mRNA is achieved by means of complementary short interfering RNA (siRNA) molecules. This advanced therapeutic approach, using siRNA technology as a targeted inhibitor, affords a tractable strategy to combat influenza pathogenesis. SiRNAs are easy to design, and can be directed against multiple strains of the influenza virus by targeting their conserved gene regions. The newly established partnership between Sirnaomics and Walvax will specifically focus on development of the siRNA-based anti-influenza therapeutic candidate STP702.

"Establishing this partnership with Walvax exemplifies our continued execution for development strategy," said Patrick Lu, PhD, President and CEO of Sirnaomics, and Chairman of Sirnaomics Suzhou. "The out-licensing of our antiviral siRNA candidate, especially to an internationally well-recognized biopharma company like Walvax Bio that specializes in development of vaccine and therapeutics against various viral infections, marks a major milestone in Sirnaomics’ growth. I look forward to seeing the Sirnaomics and Walvax teams working together to develop a novel siRNA therapeutic to combat potential influenza epidemics of the future."

"We believe our siRNA technology has extremely broad therapeutic potential and we are excited to combine Walvax’s deep vaccine expertise with our siRNA platform technology to unlock additional value outside of our core oncology and fibrosis therapeutic focus," said Allan Shaw, Chief Financial Officer at Sirnaomics. "This alliance provides the latest validation of Sirnaomics technology platform and furthers our strategy to evaluate its potential in a wide range of new disease areas."

About STP702
Sirnaomics team has been working diligently on finding a better alternative for prophylaxis and therapeutic treatment of Influenza A. In silico design and in vitro screening (H1N1 in a P2- and H7N9 in a P3-environment) led to the identification of potent siRNA sequences targeting the most conserved regions of Influenza viral genes, and these siRNAs exhibited a broad anti-influenza activity. Through rational pairing of these potent siRNA oligos, a specific combination of two siRNA sequences can further improve efficacy by demonstrating synergistic antiviral activity while also broadening the potential coverage of Influenza strains. The most critical technical advancements are the nanoparticle-enhanced siRNA delivery (STP702) in the viral-challenged mouse models, resulting in more potent anti-influenza activity than the marketed chemo drugs: Ribavirin and Tamiflu.

These results are the first demonstration of a synergistic therapeutic effect from combining siRNAs in a single delivery system. They also demonstrate the utility of nanoparticle mediated delivery of siRNAs through IP administration and suggest that these siRNAs may act as a broad anti-Influenza therapeutic – offering a rapid response to newly emerging viral outbreaks where existing therapeutics and vaccines are ineffective. Finally, mutations in select gene segments within the virus can confer resistance to existing therapeutics, while the use of STP702 containing siRNAs against two distinct gene segments within the influenza viruses should greatly reduce the ability of the virus to escape therapeutic pressure and reduce this additional threat.

ERYTECH Announces $30.0 Million Registered Direct Offering

On April 29, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP) (the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it has entered into definitive agreements with several health-care focused institutional and accredited investors for the purchase and sale of 1,034,483 units ("Units"), each Unit consisting of four ordinary shares in the form of American Depositary Shares (each an "ADS") and three warrants, each to purchase one ordinary share (each a "Warrant"), in a registered direct offering to specified categories of investors, described below (Press release, ERYtech Pharma, APR 29, 2021, View Source [SID1234578753]). The subscription price for one Unit is $29.00 (€24.03), corresponding to $7.25 (€6.01) per ADS and associated 0.75 warrant. Each ADS represents the right to receive one ordinary share, €0.10 nominal value, of the Company. The Warrants have an exercise price of €7.50 ($9.05) per share, will be immediately exercisable upon issuance and will expire two years from the issuance date. The closing of the offering is expected to occur on or about May 4, 2021, subject to satisfaction of customary closing conditions.

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Oncolytics Biotech® Announces Upcoming Presentation at the American Society of Clinical Oncology Annual Meeting

On April 29, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the acceptance of an abstract discussing its pancreatic adenocarcinoma trial at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is taking place virtually from June 4 – 8, 2021 (Press release, Oncolytics Biotech, APR 29, 2021, View Source [SID1234578773]). Details on the abstract and a corresponding poster presentation are shown below.

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Title: Treatment with pembrolizumab in combination with the oncolytic virus pelareorep promotes anti-tumor immunity in patients with advanced pancreatic adenocarcinoma
Presentation Type: Electronic poster
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4144

The abstract will be published on the ASCO (Free ASCO Whitepaper) Annual Meeting website at 5:00 p.m. ET on May 19, 2021. The corresponding poster will be made available on the meeting website at 9:00 a.m. ET on June 4, 2021.

Labcorp Announces 2021 First Quarter Results

On April 29, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the first quarter ended March 31, 2021 and raised 2021 guidance. (Press release, LabCorp, APR 29, 2021, View Source [SID1234578791]).

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"We delivered very strong results in the first quarter driven by revenue growth across both our Diagnostics and Drug Development businesses," said Adam H. Schechter, chairman and CEO, Labcorp. "Overall revenue in our base business grew 14.6% as people continued to return to their pre-pandemic healthcare routines and our biopharmaceutical clients resumed their important research and development. Our drug development pipeline remained robust, with a book-to-bill of 1.47 on a trailing twelve-month basis driven by strong demand across major therapeutic areas."

In the quarter, Labcorp continued to bring science and technology innovations to market quickly to improve health and improve lives. The company opened a fully automated kit production facility in Belgium to support its Central Lab customers, ultimately improving access and cost efficiency for biopharma and clinical trial clients across Europe, the Middle East and Africa. In the fight against COVID-19, Labcorp expanded its work with the CDC to identify variants to the virus, and now offers Pixel by Labcorp COVID-19 home collection kits in thousands of pharmacies across the United States.

"We are pleased with our strong first quarter performance and improved outlook, and are raising our full year adjusted EPS guidance range to between $20.00 and $24.00. I am proud of our more than 70,000 employees and their commitment to our patients and customers during this pandemic and the difference they are making in the lives of people around the world," said Schechter.

Consolidated Results

First Quarter Results

Revenue for the quarter was $4.16 billion, an increase of 47.4% over $2.82 billion in the first quarter of 2020. The increase in revenue was due to organic growth of 45.0%, acquisitions of 0.9%, and favorable foreign currency translation of 1.4%. The 45.0% increase in organic revenue includes a 32.9% contribution from PCR and antibody testing (COVID-19 Testing) and a 12.2% increase in the company’s organic Base Business. Base Business includes Labcorp’s business operations except for COVID-19 Testing.

Operating income for the quarter was $1,057.9 million, or 25.4% of revenue, compared to ($192.6) million, or (6.8%), in the first quarter of 2020. The increase in operating income and margin was primarily due to COVID-19 Testing, organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs. The company recorded amortization, restructuring charges, and special items, which together totaled $124.0 million in the quarter, compared to $558.5 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $1,181.9 million, or 28.4% of revenue, compared to $365.9 million, or 12.9%, in the first quarter of 2020.

Net earnings (losses) for the quarter were $769.6 million, compared to ($317.2) million in the first quarter of 2020. Diluted EPS were $7.82 in the quarter, up from ($3.27) in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $8.79 in the quarter, up from $2.37 in the first quarter of 2020.

Operating cash flow for the quarter was $1,157.6 million, compared to $203.8 million in the first quarter of 2020. The increase in operating cash flow was due to higher cash earnings and lower working capital. Capital expenditures totaled $95.4 million, down from $106.6 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $1,062.2 million, up from $97.2 million in the first quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $1.9 billion and $5.4 billion, respectively. During the quarter, the company invested $34.1 million on acquisitions, repurchased $68.5 million of stock representing approximately 0.3 million shares, and paid down $375.0 million of debt. As of March 31, 2021, the company had $731.5 million of authorization remaining under its share repurchase program.

First Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.76 billion, an increase of 62.0% over $1.70 billion in the first quarter of 2020. The increase in revenue was primarily due to organic growth of 60.8%, acquisitions of 0.9%, and favorable foreign currency translation of 0.4%. The increase in organic revenue was due to a 54.5% contribution from COVID-19 Testing and a 6.3% increase in the Base Business, which includes the unfavorable impact of weather of approximately (2.0%).

Total volume (measured by requisitions) increased by 27.3% as organic volume increased by 26.6% and acquisition volume contributed 0.7%. The organic volume growth was due to a 27.9% contribution from COVID-19 Testing demand, partially offset by a (1.3%) reduction in organic Base Business, which includes the unfavorable impact from weather of approximately (2.0%). Price / mix increased by 34.7% primarily due to COVID-19 Testing of 26.6% and organic Base Business of 7.5%.

Adjusted operating income for the quarter was $991.6 million, or 36.0% of revenue, compared to $254.2 million, or 14.9%, in the first quarter of 2020. The increase in adjusted operating income and adjusted operating margin were primarily due to the increase in COVID-19 Testing, organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development

Revenue for the quarter was $1.44 billion, an increase of 25.7% over $1.14 billion in the first quarter of 2020. The increase in revenue was due to organic growth of 21.9%, acquisitions of 1.0%, and favorable foreign currency translation of 2.9%. The increase in organic revenue was due to a 19.7% increase in the Base Business and a 2.2% contribution from COVID-19 Testing performed through its Central Laboratories business. Drug Development benefited from broad-based demand across businesses, including COVID-19 vaccine and therapeutic work.

Adjusted operating income for the quarter was $234.1 million, or 16.3% of revenue, compared to $150.8 million, or 13.2%, in the first quarter of 2020. The increase in adjusted operating income and adjusted operating margin were primarily due to organic Base Business growth, COVID-19 Testing, and LaunchPad savings, partially offset by higher personnel costs. The company continues to develop and execute new LaunchPad programs to support profitable growth in Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $7.61 billion and 1.47, respectively. Backlog at the end of the quarter was $13.97 billion, compared to $13.76 billion last quarter, and the company expects approximately $4.62 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2021

Labcorp is raising its 2021 full year guidance to reflect the improved recovery in the Diagnostics and Drug Development base businesses, while the COVID-19 Testing contribution remains within the original guidance range provided. The following guidance assumes foreign exchange rates effective as of March 31, 2021 for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(1) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.7%, Previous 2021 Guidance was 0.9%

(2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue

(3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.3%, Previous 2021 Guidance was 0.1%

(4) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.4%, Previous 2021 Guidance was 2.2%

(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-898-8036 (720-634-2811 for international callers). The conference ID is 6566853. A telephone replay of the call will be available through May 13, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 6566853. A live online broadcast of Labcorp’s quarterly conference call on April 29, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through April 15, 2022.