On August 8, 2023 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results for the second quarter and first half of 2023 (Press release, Qiagen, AUG 8, 2023, View Source [SID1234633987]).

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Net sales results of $497 million at constant exchange rates (CER) for Q2 2023 were above the outlook for at least $490 million CER, driven by 9% CER growth in the non-COVID-19 portfolio. Overall sales results for Q2 2023 declined 4% (-4% CER) to $495 million from Q2 2022, a period marked by significant COVID-19 sales. Adjusted diluted earnings per share (EPS) were $0.51, and results of $0.52 CER were above the outlook for at least $0.50 CER.

QIAGEN has revised its full-year 2023 outlook for net sales of at least $1.97 billion (prior $2.05 billion CER) due mainly to the significant drop in COVID-19 test demand and volatility in large-scale customer bulk orders in the OEM (Original Equipment Manufacturer) business, which impacts both COVID and non-COVID sales results. Sales growth from the non-COVID product groups is now expected to be at least 8% CER, driven by ongoing solid consumables demand across the portfolio. Adjusted diluted EPS are now expected to be at least $2.07 CER (prior $2.10 CER).

"Our teams at QIAGEN exceeded the outlook we set for both sales and profitability in the second quarter of 2023," said Thierry Bernard, Chief Executive Officer of QIAGEN. "This performance was especially important given the significant drop-off in COVID-19 testing and challenging macro environment."

"We are executing on a strategy to develop our portfolio across the Life Sciences and Molecular Diagnostics customer classes. The solid 9% CER sales growth in our non-COVID business shows the resilience of this portfolio, with 10% CER growth in our highly recurring consumables portfolio across all customer classes and led by QuantiFERON quarterly sales exceeding $100 million for the first time. We are well-positioned to continue our track record of delivering solid sales growth trends well beyond 2023 as we as we move beyond the impact of COVID-19 headwinds."

Roland Sackers, Chief Financial Officer of QIAGEN, said: "Our results show the resilience of our portfolio due to the significant share of recurring consumables revenues. Despite making significant investments into the business, particularly R&D investments that were about 10% of sales in the first half of 2023, QIAGEN achieved an adjusted operating income margin above 27% of sales in the second quarter of 2023 as we exceeded our targets for both sales and adjusted EPS."

Please find a PDF of the full press release incl. tables here.

Investor presentation and conference call

A conference call is planned for Wednesday, August 9, 2023 at 15:00 Frankfurt Time / 14:00 London Time / 9:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a recording will also be made available after the event. A presentation is planned to be available before the conference call at View Source

Use of adjusted results

QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, and other non-U.S. GAAP figures (generally accepted accounting principles), to provide additional insight into its performance. These results include adjusted net sales, adjusted gross income, adjusted gross profit, adjusted operating income, adjusted operating expenses, adjusted operating income margin, adjusted net income, adjusted net income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted EPS, adjusted income taxes, adjusted tax rate, and free cash flow. Free cash flow is calculated by deducting capital expenditures for Property, Plant & Equipment from cash flow from operating activities. Adjusted results are non-GAAP financial measures that QIAGEN believes should be considered in addition to reported results prepared in accordance with GAAP but should not be considered as a substitute. QIAGEN believes certain items should be excluded from adjusted results when they are outside of ongoing core operations, vary significantly from period to period, or affect the comparability of results with competitors and its own prior periods. Furthermore, QIAGEN uses non-GAAP and constant currency financial measures internally in planning, forecasting and reporting, as well as to measure and compensate employees. QIAGEN also uses adjusted results when comparing current performance to historical operating results, which have consistently been presented on an adjusted basis.

On August 8, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the second quarter ended June 30, 2023 and provided recent business highlights (Press release, Personalis, AUG 8, 2023, View Source [SID1234633986]).

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Recent Business Updates

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Announced a collaboration with National Cancer Center Hospital East and Ono Pharmaceutical Co. Ltd to perform exploratory biomarker analysis using highly sensitive and comprehensive genomic tests from Personalis to better predict immunotherapy response for resectable rectal cancer with mismatch repair deficiency (dMMR)

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Received notice from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) that it has exercised the first of four one-year renewal options under the September 2022 contract

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Filed second patent infringement lawsuit against Foresight Diagnostics as part of the company’s continuing efforts to protect its investment and industry-leading intellectual property position in whole genome, tumor-informed minimal residual disease (MRD) testing

"We continue expanding our biopharma funnel of opportunities for NeXT Personal and expect revenue growth to begin ramping later this year, which allowed us to tighten the revenue guidance range," said Chris Hall, President and CEO of Personalis. "We continue to crisply execute and plan to launch our highly sensitive MRD test later this year for oncologists. As we and our partners build a base of supportive evidence, we are paving the way for our successful entry into the clinical diagnostics market."

Second Quarter Financial Highlights

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Reported total company revenue of $16.7 million for the second quarter of 2023, representing an 8% decrease compared with $18.2 million for the second quarter of 2022

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Revenue from pharma tests, enterprise sales, and other customers of $13.7 million in the second quarter of 2023, representing a 3% decrease compared with $14.2 million in the second quarter of 2022; revenue from enterprise customers includes revenue from Natera of $7.4 million in the second quarter of 2023, compared with $6.9 million from Natera in the second quarter of 2022

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Revenue from population sequencing for the VA MVP of $3.0 million in the second quarter of 2023, compared with $4.0 million in the second quarter of 2022

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Cash, cash equivalents, and short-term investments of $137.2 million as of June 30, 2023

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Net loss of $24.0 million, and net loss per share of $0.50 based on a weighted-average basic and diluted share count of 47.7 million in the second quarter of 2023

Third Quarter and Full Year 2023 Outlook

Personalis expects the following for the third quarter of 2023:

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Total company revenue of approximately $17 million
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Revenue from pharma tests, enterprise sales, and other customers of approximately $14 million, and revenue from population sequencing of approximately $3 million

Personalis expects the following for the full year of 2023:

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Total company revenue in the range of $70 million to $72 million
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Revenue from pharma tests, enterprise sales, and all other customers in the range of $61 million to $63 million, and revenue from population sequencing of approximately $9 million
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Net loss of approximately $103 million reduced from $113 million in 2022 due to realization of headcount reduction savings, partially offset by investments in clinical evidence generation and non-cash depreciation expense for the new facility
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Cash usage of approximately $70 million, reduced from $119 million in 2022

Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter financial results after market close on Tuesday, August 8, 2023 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On August 8, 2023 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Olema Oncology, AUG 8, 2023, View Source [SID1234633985]).

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"Olema is on track to deliver on significant milestones this year, including initiating our first pivotal Phase 3 trial, OPERA-01, which will test palazestrant (OP-1250) as a monotherapy in the second- and third-line metastatic setting, as well as presenting new data from our ongoing monotherapy and combination clinical studies," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We are actively engaged in start-up activities for our OPERA-01 Phase 3 clinical trial, with enrollment expected to begin in the fourth quarter. Among other upcoming milestones, we look forward to presenting our mature Phase 2 monotherapy data as part of an oral presentation at the ESMO (Free ESMO Whitepaper) Congress in Madrid in October. Our goal with palazestrant remains to significantly improve upon current standard-of-care endocrine therapy as the backbone treatment for metastatic breast cancer."

Recent Corporate Highlights

● Presented interim Phase 1b/2 clinical study results of palazestrant in combination with a CDK4/6 inhibitor (palbociclib) at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin, Germany. Results demonstrated no dose-limiting toxicities and no observed drug-drug interaction, with an overall tolerability profile of the combination consistent with the FDA-approved label of palbociclib plus an endocrine agent.
● Presented trials-in-progress poster from the ongoing Phase 1b/2 dose escalation and dose expansion study of palazestrant in combination with CDK4/6 inhibitor, ribociclib or PI3Ka inhibitor, alpelisib at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

Upcoming Milestones

● Present palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain, on October 22, 2023.
● Present palazestrant interim Phase 1b/2 clinical study results in combination with CDK4/6 inhibitor, palbociclib, in the fourth quarter of 2023.

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● Present palazestrant interim Phase 1b clinical study results in combination with CDK4/6 inhibitor, ribociclib, in the fourth quarter of 2023.
● Initiate OPERA-01, Olema’s first pivotal Phase 3 clinical trial, testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer, anticipated in the fourth quarter of 2023.

Second Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2023, were $167.4 million, a reduction of approximately $18.6 million from the quarter ended March 31, 2023. Olema anticipates that this balance will be sufficient to fund operations into the second quarter of 2025.

Net loss for the quarter ended June 30, 2023, was $20.1 million, as compared to $32.9 million for the same period of the prior year. The decrease in net loss was primarily related to decreased spending on discovery research activities including a one-time upfront payment of $8.0 million to Aurigene Pharmaceuticals in June 2022 pursuant to the exclusive global license agreement entered into in June 2022 between the Company and Aurigene Pharmaceuticals (the Aurigene Agreement), and general and administrative activities including a reduction in corporate- and legal-related costs, which were primarily offset by increased spending on clinical development and operations-related activities as we continue to advance palazestrant into late-stage clinical development.

GAAP research and development (R&D) expenses were $18.0 million for the quarter ended June 30, 2023, as compared to $27.1 million for the quarter ended June 30, 2022. The decrease was primarily due to decreased spending on (i) preclinical research programs, which included the $8.0 million upfront payment in connection with the Aurigene Agreement incurred and paid in June 2022, (ii) clinical pharmacology-related costs, and (iii) personnel-related expenses, which primarily related to lower headcount as a result of the restructuring and portfolio prioritization during the first quarter of 2023, and a decrease of approximately $0.2 million in non-cash stock-based compensation expense. Total decreases were primarily offset by increased spending on clinical operations-related activities as we continue to advance palazestrant into late-stage clinical trials.

Non-GAAP R&D expenses were $15.0 million for the quarter ended June 30, 2023, excluding $3.0 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $23.8 million for the quarter ended June 30, 2022, excluding $3.2 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found in the tables below.

GAAP general and administrative (G&A) expenses were $3.6 million for the quarter ended June 30, 2023, as compared to $6.2 million for the quarter ended June 30, 2022. The decrease in G&A expenses was primarily due to decreased spending on (i) corporate- and legal-related costs, and (ii) personnel-related expenses, primarily due to lower headcount as a result of the restructuring and portfolio prioritization, and a decrease of approximately $0.3 million in non-cash stock-based compensation expense.

Non-GAAP G&A expenses were $2.4 million for the quarter ended June 30, 2023, excluding $1.2 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $4.7 million for the quarter ended June 30, 2022, excluding $1.5 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found in the tables below.

On August 8, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported financial results for the second quarter 2023 along with recent pipeline and corporate updates (Press release, Mirati, AUG 8, 2023, View Source [SID1234633984]).

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"We are pleased to share the significant progress made during the second quarter of 2023, highlighted by an update to the clinical data and articulation of our path to develop KRAZATI in front line non-small cell lung cancer (NSCLC). Coupled with strong second quarter KRAZATI sales performance, these data reinforce our belief that KRAZATI is the best-in-class KRASG12C inhibitor with significant potential to positively impact the lives of patients living with cancer," said Charles Baum, M.D, Ph.D., interim CEO, president and founder, Mirati Therapeutics, Inc. "Further, we advanced our robust pipeline of targeted oncology programs, including MRTX1719, our potentially first-in-class MTA cooperative PRMT5 inhibitor, where we demonstrated a favorable safety profile, proof of mechanism and compelling early clinical activity in patients with MTAP-deleted cancers. Looking ahead, we are confident in the potential of our broad pipeline of innovative, potentially best-in-class programs including MRTX1133 and our next generation of KRAS inhibitors, as well as MRTX1719 and MRTX0902, our SOS1 inhibitor. We continue to demonstrate our proven expertise in the discovery and development of transformational treatments to people living with cancer."

Pipeline Updates

Adagrasib (Potent and selective KRASG12C inhibitor)

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In August, the Company shared updated clinical data in first-line NSCLC for the combination of adagrasib with pembrolizumab. The Company announced plans to begin enrolling patients with TPS ≥ 50% in a Phase 3 clinical study by year-end 2023.

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In August, the Company shared that KRYSTAL 17, a Phase 2 clinical study evaluating adagrasib in combination with chemo-immunotherapy for patients with TPS < 50% has been initiated. The Company intends to provide an update on this study and outline potential registrational development plans in 2024.

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In July, the company announced the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the Conditional Marketing Authorisation Application (MAA) for KRAZATI (adagrasib) for the treatment of patients with KRASG12C -mutated advanced NSCLC. The evaluation of the full MAA is not impacted and will be considered by the CHMP following the data from KRYSTAL-12, a Phase 3 clinical study of adagrasib versus docetaxel in second line NSCLC patients. The Company has requested a formal reexamination of the Conditional MAA. (View Release)

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In June, the Journal of Clinical Oncology published clinical results from the KRYSTAL-1 study of adagrasib, a potent and selective KRASG12C inhibitor, demonstrating durable intracranial activity in patients living with KRASG12C-mutated NSCLC with untreated central nervous system metastases. (View Release)

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In June, the Company presented updated clinical data for adagrasib as a targeted treatment for KRASG12C-mutated advanced pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer and other solid tumors at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Based on these results, the Company plans to discuss a tumor agnostic Accelerated Approval approach with FDA by year-end 2023. (View Release)

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The Company is on track to complete a supplemental New Drug Application (sNDA) for third-line and beyond colorectal cancer in patients with a KRASG12C mutation by year-end 2023.

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The Company continues to enroll in KRYSTAL-10, a Phase 3 registrational clinical study in second-line colorectal cancer patients, evaluating the combination of adagrasib plus cetuximab versus chemotherapy. The Company expects to complete enrollment by year-end 2023 and plans to share top line results in 2024.

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The Company continues to enroll in KRYSTAL-12, a Phase 3 clinical study of adagrasib versus docetaxel in second line NSCLC patients. The Company plans to share data from this study in 2024.

MRTX1719 (MTA cooperative PRMT5 inhibitor)

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In August, the Company presented initial clinical data from the Phase 1 dose escalation clinical study evaluating MRTX1719, an MTA cooperative PRMT5 inhibitor, in patients with solid tumors harboring MTAP-gene deletions, demonstrating a favorable safety profile and early signs of clinical activity. A manuscript characterizing the Company’s preclinical and early clinical experience with 1719 including case studies from the Phase 1 study was accepted by Cancer Discovery and will publish online on August 8, 2023. The Company expects to initiate a Phase 2 study in the first half of 2024.

MRTX1133 (Potent and selective KRASG12D inhibitor)

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The Company continues to enroll patients in the Phase 1/2 clinical study with plans to share initial clinical data in the first half of 2024.

MRTX0902 (Potent SOS1 inhibitor)

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In July, the Company initiated a cohort within the Phase 1/2 trial evaluating the combination of MRTX0902 plus adagrasib with plans to share initial clinical data in 2024.

Sitravatinib (Potent TAM receptor inhibitor)

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In May, the Company announced that the Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC study did not meet its primary endpoint of overall survival at the final analysis. The Company plans to disclose study data at an upcoming medical meeting. (View Release)

Recent Corporate Updates

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In August, the Company announced that David Meek departed as CEO. Charles Baum, M.D., Ph.D., will assume the role of interim CEO while the Company searches for a permanent CEO.

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In June, the Company announced Carol Gallagher, Pharm.D. was appointed to the Company Board of Directors as an independent director. (View Release)

Second Quarter Financial Results

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Cash, cash equivalents and short-term investments of approximately $779.4 million as of June 30, 2023. Net reduction in cash, cash equivalents and short-term investments for the second quarter of 2023 was $122.9 million. The Company expects 2023 net cash burn to annualize within a range of $560 million to $580 million.

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Net KRAZATI product revenue for the three and six months ended June 30, 2023 was $13.4 million and $19.7 million, respectively. Net product revenue during the three months ended June 30, 2023 was comprised of $11.7 million of commercial sales and $1.7 million of sales to a third-party commercial customer for its clinical trials. There was no product revenue for the same periods in 2022.

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License and collaboration revenue for the three and six months ended June 30, 2023 was $0.3 million and $1.2 million, respectively, related to clinical supply revenue earned under the agreement with Zai Lab. License and collaboration revenue for the same periods in 2022 was $5.4 million and $6.1 million, respectively, related to a $5 million milestone payment from Zai Lab for the initiation of the first pivotal clinical trial of adagrasib for the first indication in China, and clinical supply revenue earned under the agreement with Zai Lab.

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Cost of product revenue for the three and six months ended June 30, 2023 was $1.3 million and $2.1 million, respectively, of which $1.0 million and $1.6 million, respectively, related to product manufacturing and distribution costs, and royalties incurred on net sales of KRAZATI, and the remainder represented non-cash amortization expense for our intangible asset. There was no cost of product revenue for the same periods in 2022.

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Research and development expenses for three and six months ended June 30, 2023 were $124.2 million and $250.9 million, respectively, compared to $128.3 million and $259.3 million for the same periods in 2022, respectively. The decrease was primarily driven by a reduction in clinical development costs for sitravatinib as enrollment was completed in the SAPPHIRE Phase 3 clinical study in the second quarter of 2022, and a decrease in share-based compensation due to a decrease in the fair value of equity awards granted during the period, partially offset by increases in costs for earlier stage clinical development programs such as MRTX1133, and an increase in salaries and other employee related expense to support portfolio advancement.

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Selling, general and administrative expenses for the three and six months ended June 30, 2023 were $75.5 million and $149.0 million, respectively, compared to $54.2 million and $108.2 million, respectively for the same periods in 2022. The increases were primarily due to an increase in headcount-related costs, including share-based compensation and salaries, and commercial-related costs to support the marketing and sales of KRAZATI.

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Net loss for the three months ended June 30, 2023 was $176.9 million, or $3.04 per share basic and diluted, compared to a net loss of $176.4 million, or $3.18 per share basic and diluted for the same period in 2022. Net loss for the six months ended June 30, 2023 was $361.5 million, or $6.22 per share basic and diluted, compared to a net loss of $364.8 million, or $6.57 per share basic and diluted for the same period in 2022.

Conference Call Information

There will be a conference call on August 8, 2023 at 5:30 p.m. ET / 2:30 p.m. PT during which company executives will review financial information for the second quarter and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-394-8218, confirmation code: 6674271.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.

On August 8, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and provided financial results for the second quarter ended June 30, 2023 (Press release, Mersana Therapeutics, AUG 8, 2023, View Source [SID1234633983]).

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"Mersana has focused heavily on the development of new product candidates and business development opportunities that leverage our innovative next-generation ADC platforms," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "These efforts have yielded promising new programs based on our Dolasynthen and Immunosynthen platforms that have the potential to benefit a wide range of patients who are waiting for new treatment options. Given the strength of our balance sheet, pipeline and collaborations, we are very excited about the opportunities ahead for Mersana."

Mersana’s Strategic Priorities

Advance XMT-1660 and Dolasynthen Platform: Dolasynthen is Mersana’s next-generation cytotoxic ADC platform that is designed to generate site-specific, homogeneous ADCs, utilizes a proprietary auristatin payload and has the ability to match the drug-to-antibody ratio to specific targets. The company is advancing the development of XMT-1660, a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6). Mersana expects to complete the dose escalation portion of its Phase 1 clinical trial of this candidate in 2023 and initiate the dose expansion portion of the trial in 2024. Additionally, Mersana is supporting Janssen Biotech under a collaboration and license agreement that focuses on discovering novel Dolasynthen ADCs for up to three targets.

Advance XMT-2056 and Immunosynthen Platform: Immunosynthen is Mersana’s proprietary STING agonist platform that is designed to generate systemically administered ADCs that locally activate STING signaling in both tumor-resident immune cells and in antigen-expressing cells to unlock the anti-tumor potential of innate immune stimulation. Mersana is working diligently to address the clinical hold on its Phase 1 clinical trial of XMT-2056, its lead Immunosynthen ADC candidate, which targets a novel HER2 epitope. GSK plc has an exclusive option to co-develop and commercialize XMT-2056. Additionally, Mersana is supporting Merck KGaA, Darmstadt, Germany under a collaboration and license agreement that focuses on discovering novel Immunosynthen ADCs for up to two targets.

Second Quarter 2023 Financial Results

Net cash used in operating activities for the second quarter of 2023 was $61.8 million.
Cash, cash equivalents and marketable securities as of June 30, 2023 were $286.6 million, compared to $280.7 million as of December 31, 2022. Mersana expects that its available funds will be sufficient to support its current operating plan commitments into 2026.
Collaboration revenue for the second quarter of 2023 was $10.7 million, compared to $4.3 million for the same period in 2022. The year-over-year increase was primarily related to Mersana’s collaboration agreements with Janssen Biotech and Merck KGaA, Darmstadt, Germany.
Research and development (R&D) expenses for the second quarter of 2023 were $49.0 million, compared to $41.2 million for the same period in 2022. Included in second quarter 2023 R&D expenses were $3.4 million in non-cash stock-based compensation expenses. The year-over-year increase in R&D expenses was primarily related to higher manufacturing and clinical costs related to UpRi and an increase in headcount.
General and administrative (G&A) expenses for the second quarter of 2023 were $18.2 million, compared to $14.8 million during the same period in 2022. Included in second quarter 2023 G&A expenses were $3.2 million in non-cash stock-based compensation expenses. The year-over-year increase in G&A expenses was primarily related to increases in headcount and UpRi-related professional services.
Net loss for the second quarter of 2023 was $54.3 million, or $0.47 per share, compared to a net loss of $52.2 million, or $0.55 per share, for the same period in 2022.