Precision BioSciences to Report Second Quarter 2022 Financial Results on August 8, 2022

On August 1, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that it will publish financial results for the second quarter 2022 and provide a business update on August 8, 2022 (Press release, Precision Biosciences, AUG 1, 2022, View Source [SID1234617199]).

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PerkinElmer Announces Financial Results for the Second Quarter of 2022

On August 1, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the second quarter ended July 3, 2022 (Press release, PerkinElmer, AUG 1, 2022, View Source [SID1234617198]).

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The Company reported GAAP earnings per share from continuing operations of $1.42, as compared to GAAP earnings per share from continuing operations of $2.19 in the same period a year ago. GAAP revenue for the quarter was $1.23 billion, as compared to $1.23 billion in the same period a year ago. GAAP operating income from continuing operations for the quarter was $251 million, as compared to $332 million for the same period a year ago. GAAP operating profit margin was 20.4% as a percentage of revenue, as compared to 27.1% in the same period a year ago.

Adjusted earnings per share from continuing operations for the quarter was $2.32, as compared to $2.83 in the same period a year ago. Adjusted revenue for the quarter was $1.23 billion, as compared to $1.23 billion in the same period a year ago. Adjusted operating income from continuing operations for the quarter was $402 million, as compared to $411 million for the same period a year ago. Adjusted operating profit margin was 32.7% as a percentage of adjusted revenue, as compared to 33.5% in the same period a year ago.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"Our strong performance in the quarter is a testament to our operational and commercial execution as well as our portfolio evolution over the last three years," said Prahlad Singh, president and chief executive officer of PerkinElmer. "With today’s divestiture announcement, we position the company to transform into a pureplay, high growth, high margin life sciences and diagnostics company with even more focus to capitalize on attractive end markets. This transformation will in turn lead to significant financial strength, allowing us to continue to scale and accelerate our innovation investments, which help our customers bridge the chasm from research to clinic, and clinic to cure."

Financial Overview by Reporting Segment for the Second Quarter

Discovery & Analytical Solutions

Second quarter 2022 revenue was $661 million, as compared to $513 million in the same period a year ago. Reported revenue increased 29% and organic revenue increased 13% as compared to the same period a year ago.
Second quarter 2022 operating income from continuing operations was $70 million, as compared to $64 million for the same period a year ago.
Second quarter 2022 adjusted operating income was $178 million, as compared to $101 million for the same period a year ago.
Diagnostics

Second quarter 2022 revenue was $569 million, as compared to $716 million for the same period a year ago. Reported revenue decreased 20% and organic revenue decreased 19% as compared to the same period a year ago.
Second quarter 2022 operating income from continuing operations was $201 million, as compared to $286 million for the same period a year ago.
Second quarter 2022 adjusted operating income was $245 million, as compared to $328 million for the same period a year ago.
Initiates Third Quarter and Raises Full Year 2022 Guidance

For the third quarter of 2022, the Company forecasts revenue of approximately $1.02-1.03 billion and adjusted earnings per share to be in a range $1.40-1.45.

For the full year 2022, the Company now forecasts revenue of $4.60-4.64 billion and adjusted earnings per share of $7.80-7.90.

Guidance for the third quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Announces Agreement with the Intention to Divest Applied, Food, and Enterprise Services Businesses

The Company is also announcing today that it has entered into an agreement with the intention to divest its Applied, Food, and Enterprise Services businesses to New Mountain Capital for a total consideration of $2.45 billion. The transaction is expected to close in the first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Management will provide additional detail regarding this transaction in a separate release and on today’s webcast. A presentation highlighting this transaction will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Webcast Information

The Company will discuss its second quarter 2022 results, its outlook for business trends, and its intended divestiture of its Analytical, Food, and Enterprise Services businesses during a webcast on August 1, 2022, at 8:00 a.m. Eastern Time. A live audio webcast and presentation will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "estimates", "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and divestitures, such as the divestiture of the Applied, Food and Enterprise Services businesses, license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our ability to compete effectively; (7) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (8) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (9) disruptions in the supply of raw materials and supplies; (10) our ability to retain key personnel; (11) significant disruption in our information technology systems, or cybercrime; (12) our ability to realize the full value of our intangible assets; (13) our failure to adequately protect our intellectual property; (14) the loss of any of our licenses or licensed rights; (15) the manufacture and sale of products exposing us to product liability claims; (16) our failure to maintain compliance with applicable government regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) the United Kingdom’s withdrawal from the European Union; (21) our ability to obtain future financing; (22) restrictions in our credit agreements; (23) discontinuation or replacement of LIBOR; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

OriCell Therapeutics Raises Over $120 Million in Series B Financing Led by Qiming Venture Partners and Quan Capital to Advance Cell Therapies for Cancer Immunology

On August 1, 2022 OriCell Therapeutics (Shanghai) Co., Ltd. ("OriCell" or "the Company") reported the completion of Series B financing totaling over US$120 million (Press release, OriCell Therapeutics, AUG 1, 2022, View Source [SID1234617197]). This round of financing was jointly led by Qiming Venture Partners and Quan Capital with participation by several leading international and Chinese investment funds, as well as existing shareholder C&D Emerging Capital. The new funding will go toward the development of OriCell’s cell therapy pipeline, and Company’s proprietary discovery platform, as well as the construction of a manufacturing plant for both clinical and commercial purposes.

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Helen Yang, Chairman and CEO of OriCell, stated, "We are grateful to our new and existing investors for their continued support in OriCell. We have achieved a number of significant milestones in terms of clinical development of our CAR-T and partnered bispecific antibody programs, as well as continued to strengthen our senior management team. We look forward to delivering more innovative discoveries and clinical milestones in the next three years. In today’s open, inclusive, and dynamic innovative pharmaceutical ecosystem in China, we endeavor to become a world leading cell therapy company with a broad vision that can integrate seamlessly into the global market."

OriCell’s Investigational New Drug (IND) submission for Ori-C101, Company’s first internally developed CAR-T product targeting GPC3 for the treatment of advanced liver cancer, was accepted by the National Medical Products Administration (NMPA) of China in June of this year. In data published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, Ori-C101 demonstrated superior safety and efficacy in patients with GPC3-positive advanced liver cancer with an objective response rate (ORR) of 44% and disease control rate (DCR) of 78%. The longest follow-up thus far is more than 22 months, with additional follow-ups ongoing.

OriCAR-017, China’s first GPRC5D CAR-T product developed by OriCell for the treatment of relapsed and refractory multiple myeloma (RRMM) confirmed the product’s potential with clinical results from the investigator-initiated phase I trial (POLARIS) was presented in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)2022 annual meetings, respectively. In all patients, the majority of adverse events (AE) were transient, manageable, and reversible. Only Grade 1/2 cytokine release syndrome (CRS) was observed with no dose limiting toxicity (DLT), neurotoxicity, or AE-related death. Responses were durable and deepened over time with 100% ORR and 100% MRD negative rate, including in 5 prior BCMA CAR-T relapsed patients. All patients were progression-free and followed up without additional therapy by the cutoff date of April 30, 2022. Presently, OriCell is accelerating its registration and clinical development in China and the United States.

An exclusive global license agreement for OriBs-001 (ATG101) was reached with Antengene in 2019. OriBs-001 (ATG101) is a PD-L/4-1BB bispecific antibody and has received the implied approval from the Center for Drug Evaluation (CDE) in China in March this year after receiving IND from the U.S. Food and Drug Administration (FDA) and Clinical Trials Notification (CTN) from the Australian Therapeutic Goods Administration (TGA).

In March this year, Dr. Weidong Cui joined the company as Chief Technology Officer. Dr. Cui has more than 20 years of experience in process development, GMP production and commercial operation of cell therapy drug products. As the former CTO at Fosun Kite, he has led the team to successfully complete the GMP production, IND registration, and NDA registration of the first CAR-T drug in China.

MannKind Corporation to Participate in the BTIG Biotechnology Conference

On August 1, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, and Chief Financial Officer, Steven Binder will participate in the BTIG Biotechnology Conference taking place on Monday, August 8 – Tuesday, August 9, 2022 (Press release, Mannkind, AUG 1, 2022, View Source [SID1234617196]).

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This conference is being hosted by BTIG, a global financial services firm specializing in institutional trading, investment banking, research, and related brokerage services. BTIG’s Corporate Access program hosts client events across the consumer, digital assets, energy and infrastructure, financials, healthcare, real estate, and technology sectors.

Management will be participating in one-on-one meetings throughout the event. To join the conference and arrange a meeting with management, please email [email protected].

Fresenius Kabi’s regulatory submission for tocilizumab biosimilar accepted for review by FDA

On August 1, 2022 Fresenius reported that The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi’s Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra*(tocilizumab) (Press release, Fresenius, AUG 1, 2022, View Source [SID1234617195]). This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. The BLA includes presentations for both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.

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*Actemra is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.