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.

On August 1, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, AUG 1, 2022, View Source [SID1234617214]):

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Citi’s 17th Annual BioPharma Conference. Zymeworks will participate in one-on-one meetings and management will participate in a fireside chat on September 7th in Boston, MA.
2022 Wells Fargo Healthcare Conference. Zymeworks will participate in one-on-one meetings and management will participate in a fireside chat on September 8th in Boston, MA.
Morgan Stanley 20th Annual Global Healthcare Conference. Zymeworks will participate in one-on-one meetings on September 13th and 14th in New York, NY.
H.C. Wainwright 24th Annual Global Investment Conference. Zymeworks will virtually participate in one-on-one meetings on September 13th and 14th and will make available a pre-recorded presentation on September 12th.
The presentation and fireside chats will be available on Zymeworks’ website at View Source

On August 1, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported second quarter 2022 financial results and business highlights (Press release, Biomea Fusion, AUG 1, 2022, View Source [SID1234617233]).

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"The team continues to deliver against critical corporate goals as we look to build tremendous value potential for the company in the near and long-term. During the second quarter, we focused specifically on key clinical operations and clinical science activities to support COVALENT-101. Additionally, we continued to design and execute key experiments to support our diabetes effort as we march towards the clinic," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "The scaffold protein menin has many more functional responsibilities than was previously characterized and, thus, is central to multiple disease settings. Moreover, we believe our approach of covalent menin inhibition with BMF-219 offers potential safety, tolerability, efficacy and durability benefits to patients. We are now well positioned to execute a robust clinical development plan for BMF-219, which includes many liquid and solid tumor indications, as well as type 2 diabetes. Beyond menin inhibition, we are advancing toward the clinic with our second IND candidate, BMF-500, a covalent FLT3 inhibitor with best-in-class potential."

Second Quarter 2022 Pipeline Highlights

Cancer

Enrolled first patient with MM in the ongoing first-in-human Phase I clinical trial (COVALENT-101) evaluating BMF-219 in patients with relapsed or refractory acute leukemias, DLBCL, and MM
Presented Trial in Progress posters for COVALENT-101 at multiple prominent oncology conferences in the United States and in Europe
Presented preclinical data in two posters at AACR (Free AACR Whitepaper) 2022 highlighting the impact of BMF-219 on MYC- and KRAS-driven solid tumors. Building on prior data, BMF-219 exhibited robust anti-tumor effect in cell lines and PDX models in DLBCL and MM cell lines
On track to submit IND for BMF-219 in KRAS mutant NSCLC, CRC, and pancreatic ductal adenocarcinoma (PDAC) in the fourth quarter of 2022
Presented preclinical data at ASCO (Free ASCO Whitepaper) 2022 demonstrating BMF-219’s potency in multiple ex vivo tumor models of Chronic Lymphocytic Leukemia (CLL) with varying cytogenetic risk profiles, Rai stages, and resistance to standard-of-care agents indicating broad activity across these models
Announced IND candidate selection, BMF-500, a potential best-in-class oral covalent inhibitor of FLT3, one of the most frequently altered genes in AML and associated with poor prognosis
Diabetes

Presented new preclinical data in two posters at the ADA Scientific Sessions 2022, demonstrating BMF-219’s strong, prolonged glycemic control, insulin sensitization, and hemoglobin A1C (HbA1c) reduction in two preclinical rat models of diabetes while on drug and after washout, outperforming standard-of-care agents
Announced upcoming oral presentations of BMF-219 preclinical data from two animal models of diabetes at the EASD 2022 annual meeting which will include additional data not previously presented at the ADA Scientific Sessions 2022
On track to submit IND for BMF-219 in type 2 diabetes in the second half of 2022
Second Quarter 2022 Financial Results

Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $33.6 million for the six months ended June 30, 2022, compared to a net loss of $14.3 million for the same period in 2021.
R&D Expenses: Research and development expenses were $23.9 million for the six months ended June 30, 2022, compared to $9.0 million for the same period in 2021. The increase of $14.9 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
G&A Expenses: General and administrative expenses were $9.9 million for the six months ended June 30, 2022, compared to $5.3 million for the same period in 2021. The increase of $4.7 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
Cash, Cash Equivalents, Restricted Cash, and Investments: As of June 30, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $150.2 million, compared to $175.7 million as of December 31, 2021.

On August 1, 2022 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biopharmaceutical company advancing innovative precision therapeutics targeting debilitating and rare diseases, reported an overview of its strategic growth plan in conjunction with its corporate name change (Press release, Quince Therapeutics, AUG 1, 2022, View Source [SID1234619483]). The launch of Quince Therapeutics marks a strategic shift in focus as the company prioritizes the clinical development of its highly differentiated bone-targeting drug platform and lead precision bone growth molecule, NOV004, to address major, unmet medical needs across multiple skeletal therapeutic indications. Quince also announced that the company plans to pursue the strategic expansion of its development pipeline through opportunistic in-licensing and acquisition of clinical-stage assets targeting debilitating and rare diseases, in addition to disclosing the company’s intent to out-license its legacy neuroscience and antiviral assets.
Dirk Thye, M.D., Quince’s chief executive officer, said, "We are eager and enthusiastic about launching Quince Therapeutics and introducing our new corporate strategy focused on the development and acquisition of innovative precision therapeutics for patients suffering from debilitating and rare diseases. Our proprietary bone-targeting drug platform and novel lead molecule, NOV004, are positioned to establish Quince as an important new leader in underserved therapeutic areas with major and unmet medical needs in a setting of historical underinvestment and few competitive companies. Our core technology is based on more than 10 years of extensive preclinical research and can be applied to a broad variety of skeletal diseases and indications as we look to expand our proprietary pipeline.

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"We also benefit from a highly experienced management team with a long track record of drug development success and value creation. This team is empowered by a cash runway extending into the second half of 2025, providing us near-term financial security in a period of economic uncertainty in the biotech sector. This strong financial position is expected to enable us to not only fully fund reaching NOV004’s human proof of concept clinical development milestone, but also allow Quince to pursue strategic in-licensing and acquisition of additional clinical-stage assets. We intend to aggressively leverage the advantages of our strong team and balance sheet to build a highly impactful and valuable company," Thye concluded.

Strategic Growth Plan Highlights

Today, Quince embarks on a fundamental shift in its strategic growth plan that now centers on advancing innovative precision therapeutics targeting debilitating and rare diseases. Key highlights of the company’s strategic growth plan include:

Addressing major, unmet medical needs across multiple skeletal therapeutic indications

Major, unmet medical needs have been estimated to include more than 18 million fractures in the U.S. each year that have led to more than $50 billion in direct medical costs.
Underserved bone fracture opportunity compounded by a growing aging population experiencing higher rate of life-threatening fractures.
No treatments currently approved for lead indication, osteogenesis imperfecta, which has been estimated to affect as many as 50,000 people in the U.S. alone.
Positioned as a lead innovator in underserved therapeutic areas with few competitive companies.
Discovery pipeline positioned for rapid expansion across multiple skeletal therapeutic indications, including osteogenesis imperfecta, fractures, spinal fusion, and other severe bone diseases.
Strong and well-protected intellectual property with robust portfolio of precision bone therapeutics.
Highly differentiated bone-targeting drug platform and broad applicability of lead molecule NOV004

Proprietary drug-targeting technology designed to enable precise delivery of small molecules, peptides, or large molecules directly to the site of bone fracture and disease.
Development pathway de-risked by more than 10 years of extensive preclinical studies demonstrating that concentrated drug-targeting promotes more rapid healing with fewer off-target safety concerns compared to non-targeted therapeutics.
Lead precision bone growth molecule NOV004 is an anabolic peptide engineered to precisely target and concentrate at the bone fracture site, resulting in rapid increases in bone density, strength, and healing as demonstrated in preclinical studies.
NOV004 expected to enter Phase 1 clinical studies in 2023.
Future development plans include progression of NOV004 to Phase 2 clinical study to evaluate safety and efficacy for the treatment of planned lead indication, osteogenesis imperfecta.
Strategic pipeline expansion through opportunistic in-licensing and acquisition of clinical-stage assets

Proactively evaluating potentially actionable clinical-stage assets targeting debilitating and rare diseases for in-licensing and acquisition.
Potential asset targets must have compelling clinical data and commercial opportunity and offer clear operational synergy and value creation.
Intend to be opportunistic and disciplined in approach with ability to be selective and competitive in evolving biotech environment.
Strong cash position expected to fund operations and clinical activities into the second half of 2025

Strong cash position of approximately $105 million in cash, equivalents, and marketable securities as of June 30, 2022 is expected to fund capital and operating expenditures into the second half of 2025.
Expect to fully fund achievement of lead molecule NOV004’s human proof of concept clinical development milestone.
Corporate restructuring in first half of 2022 optimized organization for operating efficiency.
Out-licensing legacy neuroscience and antiviral assets

Seeking to out-license capital-intensive legacy neuroscience and antiviral assets, including COR588, COR388, COR852, and COR803.
Lysine gingipain inhibitor COR588 is Phase 2 ready for further evaluation in Alzheimer’s disease and other P. gingivalis associated diseases.
Antiviral 3CLpro irreversible inhibitor COR803 for coronavirus infection positioned at IND-enabling preclinical study phase.
Out-licensing effort to identify partners already underway with goal of concluding the process before the end of 2022.
Initiates Nasdaq Trading Under New Ticker Symbol "QNCX"

Quince’s ticker symbol on the Nasdaq Stock Market will begin to trade under "QNCX" effective at the open of market trading today, Monday, August 1, 2022. The corporate name change to Quince Therapeutics, Inc. does not affect the rights of the company’s stockholders with respect to the name change. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

Management to Participate at Upcoming Investor Conference

Quince’s chief executive officer Dirk Thye, M.D., will present at the Canaccord Genuity 42nd Annual Growth Conference taking place on Thursday, August 11, 2022 beginning at 2:30 p.m. Eastern Time. A webcast of the event will be accessible on the Investor Calendar page under the News & Events heading of Quince’s investor website at www.quincetx.com. The webcast will be archived at that location for 90 days.

On August 1, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) and Marengo Therapeutics, Inc. reported a strategic partnership to advance two of Marengo’s preclinical STAR platform-generated candidates into the clinic (Press release, Ipsen, AUG 1, 2022, View Source [SID1234617166]). The collaboration will leverage Marengo’s proprietary R&D expertise of a novel mechanism of T cell activation with Ipsen’s global oncology footprint for clinical development and commercialization.

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Under the terms of the agreement, Ipsen will make an upfront payment of $45 million, together with potential payments up to a total of $1.592 billion if all milestones are met in addition to tiered sales royalty payments. Marengo will lead the preclinical development efforts and will expense related costs until the submission of an Investigational New Drug (IND) application to the U.S. FDA. Ipsen will assume responsibilities for clinical development and commercialization.

Collectively, the Ipsen and Marengo teams have a proven track record of successful oncology-medicine development and commercialization to maximize the potential of candidates across a large range of cancer indications.

"Marengo’s foundational discovery of activation of T cell subsets via TCR Vβ is unprecedented and highly differentiated from the current immuno-oncology technologies we have seen," said Howard Mayer, M.D., Executive Vice President and Head of R&D at Ipsen. "This partnership with Marengo provides a strong foundation for a productive and successful collaboration as we embark on a journey to develop novel and durable therapies that will strengthen our oncology pipeline and further enhance our commitment to people living with cancer".

"Our strategic partnership with Ipsen underscores our shared ambition to develop transformative medicines for people fighting cancer," said Zhen Su, M.D., MBA, CEO of Marengo Therapeutics. "Marengo brings a precision medicine approach to the field of Immuno-oncology with a focus on T cell activation and this collaboration is an important validation of our STAR platform beyond our lead candidate. Together this partnership is a demonstration of the strong progress and promise of our innovative scientific platform."