On August 8, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported its financial results for the quarter ended June 30, 2023, and provided an update on corporate progress (Press release, Revolution Medicines, AUG 8, 2023, View Source [SID1234633990]).

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!

"With growing confidence in our pioneering RAS-focused drug candidate pipeline, we believe Revolution Medicines is poised for a transformative second half of the year. We intend to share significant clinical updates on our most advanced RAS(ON) Inhibitors, RMC-6236 and RMC-6291, through oral presentations at the Triple Meeting and ESMO (Free ESMO Whitepaper) in October," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Having announced last week our agreement to acquire EQRx to add more than $1 billion in additional capital to our balance sheet, we are in an especially strong position to build on this clinical momentum and continue scientific advances on behalf of patients. We are already planning one or more pivotal single agent clinical trials for RMC-6236 as well as for our first in-pipeline combination trial featuring RMC-6236 and RMC-6291."

Clinical and Development Highlights

Investigational RAS(ON) Inhibitors

RMC-6236 (RASMULTI)
RMC-6236 is an oral, RAS-selective, first-in-class RAS(ON) Inhibitor designed to treat patients with cancers driven by a wide range of common RAS mutations. Initially being evaluated as monotherapy, it may also be evaluated as a RAS Companion Inhibitor in combination with mutant-selective RAS(ON) Inhibitors and in other combination treatments.

The ongoing Phase 1/1b monotherapy trial (NCT05379985) is a multicenter, open-label, dose-escalation and dose-expansion study of RMC-6236 in patients with advanced solid tumors harboring select KRASG12 mutations, including KRASG12D, KRASG12V and KRASG12R. Preliminary data have shown promising evidence of anti-tumor activity at generally well tolerated dose levels. A maximum tolerated dose has not yet been defined and dose escalation is ongoing.
An update on the clinical antitumor activity of RMC-6236 in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer will be presented as a Proffered Paper (oral presentation) during the Developmental Therapeutics session on Sunday, October 22 at the European Society for Medical Oncology Congress 2023 (ESMO) (Free ESMO Whitepaper), and supporting clinical data will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Triple Meeting) in October 2023. Additional details for these presentations will be provided when available.
Based on encouraging data trends thus far for RMC-6236, planning is underway for one or more single agent pivotal clinical trials potentially to begin in 2024.
RMC-6291 (KRASG12C)
RMC-6291, an oral, covalent inhibitor of KRASG12C(ON) designed to treat patients with cancers driven by the KRASG12C mutant, is the first of the company’s mutant-selective RAS(ON) Inhibitors to enter clinical development and the first reported clinical-stage inhibitor of KRASG12C that uses a highly differentiated mechanism of action compared to first-generation compounds.

The ongoing Phase 1/1b monotherapy trial (NCT05462717) is a multicenter, open-label, dose-escalation and dose-expansion study of RMC-6291 in patients with advanced KRASG12C mutant solid tumors. Early findings have shown that RMC-6291 is orally bioavailable, exhibits pharmacokinetics consistent with preclinical findings, and is generally well tolerated in a pharmacologically active range.
The company will provide a first report on initial clinical findings with RMC-6291, including preliminary evidence of differentiation from RAS(OFF) inhibitors, at the Triple Meeting. Details for this presentation will be provided when available.
With encouraging initial clinical experience thus far for RMC-6291, planning is underway for a Phase 1/1b clinical trial to evaluate the combination of RMC-6236 and RMC-6291 potentially to begin in early 2024, in parallel to the continuing single agent evaluation of RMC-6291.
RMC-9805 (KRASG12D)
RMC-9805 is an oral, selective, covalent inhibitor of KRASG12D(ON), the most common driver of RAS-addicted human cancers, predominantly among patients with pancreatic cancer, NSCLC, or colorectal cancer (CRC). The company believes RMC-9805 is the first oral, mutant-selective and covalent inhibitor of KRASG12D.

Study site activation is ongoing under an investigational new drug (IND) application for a monotherapy dose-escalation Phase 1/1b trial of RMC-9805 and the company currently expects to announce dosing of the first patient in this study in the second half of 2023.
RAS Innovation Engine
Beyond the first wave of RAS(ON) Inhibitors, the company continues expanding its preclinical pipeline of RAS(ON) Inhibitor candidates.

RMC-0708 is a potent, oral, selective, first-in-class non-covalent inhibitor of the KRASQ61H(ON) cancer variant. KRASQ61H is found in lung cancer, CRC, pancreatic cancer, and multiple myeloma. RMC-0708 is the company’s first mutant-selective RAS(ON) Inhibitor drug candidate to engage its RAS target non-covalently.
RMC-8839 is a potent, oral, and selective inhibitor of KRASG13C(ON). The company believes RMC-8839 is the first compound to selectively inhibit KRASG13C, an important therapeutic target primarily for NSCLC and select CRC patients unserved by a targeted RAS inhibitor.
The company continues drug discovery efforts in RAS(ON) Inhibitor pipeline expansion programs focused on RAS mutation hotspots including KRASG12R, KRASG13D, and other important targets.
Investigational RAS Companion Inhibitors

RMC-4630 (SHP2)
RMC-4630 is a clinical-stage, oral inhibitor of SHP2, which contributes to tumor survival and growth in many RAS-addicted cancers.

RMC-4630 and KRASG12C Inhibitor Lumakras (sotorasib)

RMC-4630-03 (NCT05054725) is a global, multicenter, open-label Phase 2 study of RMC-4630 in combination with sotorasib for patients with NSCLC with a KRASG12C mutation who have failed prior standard therapy and who have not previously been treated with a KRASG12C inhibitor that the company is conducting in collaboration with Amgen.
The RMC-4630-03 study is fully enrolled, and the company plans to review a complete data set from the study when available. Decisions about future development of RMC-4630 will take into account this analysis and other considerations, including the potential of RMC-6236 as a RAS Companion Inhibitor. The company no longer plans to share topline data from the RMC-4630-03 study prior to disclosing decisions about future development of the compound.
RMC-5552 (mTORC1/4EPB1)
RMC-5552 is a first-in-class, bi-steric mTORC1-selective inhibitor designed to suppress phosphorylation and inactivation of 4EBP1 in cancers with hyperactive mTORC1 signaling, including certain RAS-addicted cancers. The company plans to evaluate RMC-5552 in combination with RAS(ON) inhibitors for patients with cancers harboring a RAS mutation and co-occurring mutations in the mTOR signaling pathway.

Dose optimization continues in the company’s ongoing multicenter, open-label, Phase 1/1b dose-escalation study evaluating RMC-5552 monotherapy in patients with refractory solid tumors (NCT04774952).
The company currently expects to provide additional characterization of the single agent profile for this compound at the upcoming Triple Meeting in October 2023.
Corporate Highlights

Acquisition of EQRx

On August 1, 2023, the company announced it entered into a definitive agreement to acquire EQRx, Inc. in an all-stock transaction intended to add more than $1 billion in net cash to the company’s balance sheet.
This proposed transaction is intended to reinforce and sustain Revolution Medicines’ parallel development approach for its extensive RAS(ON) Inhibitor pipeline in multiple RAS-driven cancers by enhancing its balance sheet.
The merger is expected to close in November 2023, subject to satisfaction of customary closing conditions, including regulatory review, and approval by Revolution Medicines’ and EQRx’s stockholders. Additional details can be found in the announcement press release as well as in Revolution Medicines’ and EQRx’s SEC filings.
Second Quarter 2023 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $909.5 million as of June 30, 2023, compared to $644.9 million as of December 31, 2022. The increase was primarily attributable to the company’s public equity offering in March 2023.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $3.8 million for the quarter ended June 30, 2023, compared to $9.1 million for the quarter ended June 30, 2022.

R&D Expenses: Research and development expenses were $98.0 million for the quarter ended June 30, 2023, compared to $61.0 million for the quarter ended June 30, 2022. The increase was primarily due to an increase in clinical trial and clinical supply manufacturing expenses for RMC-6236 and RMC-6291, research expenses associated with the company’s pre-clinical portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

G&A Expenses: General and administrative expenses were $14.6 million for the quarter ended June 30, 2023, compared to $10.2 million for the quarter ended June 30, 2022. The increase was primarily due to an increase in stock-based compensation and an increase in personnel-related expenses related to additional headcount.

Net Loss: Net loss was $98.3 million for the quarter ended June 30, 2023, compared to net loss of $61.2 million for the quarter ended June 30, 2022.

Financial Guidance
Revolution Medicines is reiterating its projected full year 2023 GAAP net loss to be between $360 and $400 million, which includes estimated non-cash stock-based compensation expense of $40 million and $50 million. Based on the company’s current operating plan, the company projects current cash, cash equivalents and investments can fund planned operations into 2025. The Company’s financial guidance excludes the financial impact of the proposed EQRx transaction.

Webcast
Revolution Medicines will host a webcast this afternoon, August 8, 2023, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On August 8, 2023 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported second quarter 2023 financial results and corporate highlights (Press release, Relay Therapeutics, AUG 8, 2023, View Source [SID1234633989]).

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!

"In the second quarter of 2023, we continued to advance our pipeline and progress our breast cancer portfolio," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "In July, we initiated the first RLY-2608 + fulvestrant dose expansion cohort. The additional RLY-2608 data supporting this decision, and the breadth of our breast cancer franchise, continue to drive our confidence that we are building a comprehensive solution for the more than 100,000 patients diagnosed with PI3Kα-mutated breast cancer in the U.S. each year."

RLY-2608 Update

In July 2023, initiated dose expansion cohort with RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2– locally advanced or metastatic breast cancer

•
Selection of 600mg BID dose supported by updated data from 17 breast cancer patients treated with RLY-2608 600mg BID + fulvestrant (cut-off date of July 24, 2023)
o
Interim clinical benefit rate (CBR) of 86 percent (6 of 7 CBR-evaluable patients) (CBR defined as the proportion of patients with stable disease, complete response, or partial response for at least 24 weeks)
o
Fifteen of 17 patients remain on treatment as of the cut-off date
o
One of five efficacy-evaluable patients with measurable disease achieved a confirmed partial response (PR) and remains on treatment as of the cut-off date (helical mutation)
o
Interim safety data compelling for use in metastatic breast cancer combinations
•
Overall, updated data strengthen the RLY-2608 profile and continue to support selective target engagement across doses and mutation types with favorable interim safety and tolerability data. As of the July 24th data cut-off, 43 total breast cancer patients had received RLY-2608 monotherapy (n=4) or RLY-2608 + fulvestrant (n=39)

Four of 24 efficacy-evaluable patients with measurable disease achieved PRs, including three confirmed (400mg BID mono with double mutation; 100mg BID combo with kinase mutation; 600mg BID combo with helical mutation) and one unconfirmed (800mg BID combo with helical mutation)
o
The interim safety profile of RLY-2608 remains consistent with safety data previously reported at AACR (Free AACR Whitepaper)
▪
No adverse event-related discontinuations
▪
No Grade 3+ hyperglycemia or diarrhea
•
Data from ongoing dose escalation arms could support decision to bring an additional dose into dose expansion in the future
•
Next data update expected in 2024

Additional Recent Corporate Highlights

RLY-4008

•
Presented full dose escalation data from the ReFocus study at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Anticipated Upcoming Milestones

•
RLY-4008
o
Complete enrollment of pivotal cohort in the second half of 2023
o
Data from non-CCA expansion cohorts in the second half of 2023
•
RLY-2608
o
Next data update expected in 2024
•
ERα degrader: development candidate nomination in 2023
•
RLY-2139 (selective CDK2 inhibitor): clinical start in early 2024, pending regulatory authorization

Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2023, cash, cash equivalents and investments totaled $871.6 million compared to approximately $1 billion as of December 31, 2022. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2025.

R&D Expenses: Research and development expenses were $88.2 million for the second quarter of 2023, as compared to $60.5 million for the second quarter of 2022. The increase was primarily due to $13.6 million of additional clinical trial expenses and $9.3 million of additional employee-related costs, which include $5.0 million of additional stock-based compensation expense.

G&A Expenses: General and administrative expenses were $20.1 million for the second quarter of 2023, as compared to $17.5 million for the second quarter of 2022. The increase was primarily due to additional employee-related costs, which include $3.3 million of additional stock-based compensation expense.

Net Loss: Net loss was $98.5 million for the second quarter of 2023, or a net loss per share of $0.81, as compared to a net loss of $76.8 million for the second quarter of 2022, or a net loss per share of $0.71.

On August 8, 2023 Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported business updates and financial results for its second quarter ending June 30, 2023 (Press release, Recursion Pharmaceuticals, AUG 8, 2023, View Source [SID1234633988]).

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!

"As the world continues to undergo a revolution in artificial intelligence and computation, Recursion is leading the TechBio sector with one of the most advanced technology-enabled drug discovery platforms in the industry," said Chris Gibson, Ph.D., Co-Founder and CEO of Recursion. "Our recent acquisitions of Cyclica and Valence and our new partnership with NVIDIA bring industry-leading capabilities to our platform that have already delivered significant value across our pipeline and partnerships. With multiple clinical catalysts in the coming quarters, the extraordinary progress in our technology, and the commitment of our teams, Recursion is making its vision of industrialized drug discovery real day by day."

Summary of Business Highlights
•Pipeline
◦Cerebral Cavernous Malformation (CCM) (REC-994): Our Phase 2 SYCAMORE clinical trial is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this drug candidate in participants with CCM.

This study was fully enrolled as of June 2023 with 62 participants and all participants who have thus far finished their first year of treatment have enrolled in the long-term extension study. We expect to share Phase 2 proof-of-concept data in H2 2024.
◦Neurofibromatosis Type 2 (NF2) (REC-2282): Our Phase 2/3 POPLAR clinical trial is a two part study of REC-2282 in participants with progressive NF2-mutated meningiomas. Part A of the study is ongoing and is exploring two doses of REC-2282 in approximately 23 adults and 9 adolescents.We expect to share Phase 2 safety, tolerability, pharmacokinetics and preliminary efficacy in H2 2024.
◦Familial Adenomatous Polyposis (FAP) (REC-4881): We have enrolled multiple participants in our TUPELO clinical trial which evaluates REC-4881 in patients with FAP. We are now providing guidance on a data readout and expect to share Phase 2 safety, tolerability, pharmacokinetics and preliminary efficacy in H1 2025.
◦AXIN1 or APC Mutant Cancers (REC-4881): We will evaluate REC-4881 in a Phase 2 biomarker enriched study in patients with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. The IND was accepted by the FDA and we expect to initiate this Phase 2 study in Q4 2023.
◦Clostridioides difficile Infection (REC-3964): Our Phase 1 clinical trial is a first-in-human protocol evaluating single and multiple doses of REC-3964 in healthy volunteers and will assess the safety, tolerability and pharmacokinetic profile of REC-3964. Single ascending dose and multiple ascending dose studies are now complete. REC-3964 has been well tolerated and no safety issues have been identified to date. We expect to share Phase 1 safety and pharmacokinetics data in Q3 2023.
◦RBM39 HR-Proficient Ovarian Cancer: RBM39 (previously identified as Target Gamma) is a novel CDK12-adjacent target identified by the Recursion OS. We believe we can modulate this target to produce a therapeutic effect in HR-proficient ovarian cancer and potentially in other tumor types. This program is in the preclinical stage and IND-enabling studies are progressing.
•Partnerships
◦NVIDIA: In July 2023, we announced a $50 million investment and collaboration with NVIDIA. We will continue to build our own foundation models for biology and chemistry and NVIDIA will assist in optimizing these models, provide priority access to computational resources on NVIDIA’s cloud service DGX Cloud, and potentially host commercially-licensable machine learning and foundation models developed by Recursion on BioNeMo, NVIDIA’s marketplace for generative AI in drug discovery. In this partnership, we will maintain control of our proprietary data and models as well as how and where we could host our technology tools as we expand our business strategy of data as a value driver. Since the announcement in July, we have already deployed our digital chemistry technology together with NVIDIA’s computational resources to predict the ligand-protein interactions for approximately 36 billion compounds in the Enamine REAL Space, reported to be the world’s largest searchable chemical library, where we evaluated 2.8 quadrillion target-compound pairs.

◦Roche-Genentech and Bayer: We continue to advance our collaborations to discover potential new therapeutics with our strategic partners Roche-Genentech and Bayer. In the near-term, there is the potential for option exercises associated with partnership programs or option exercises associated with map building initiatives or data sharing.
•Platform
◦Digital Chemistry and Generative AI Capabilities: In May 2023, we acquired Cyclica and Valence Discovery to bolster our digital chemistry and generative AI capabilities and drive value across our pipeline, partnerships, and platform. Shortly after closing these acquisitions, we used Cyclica’s digital chemistry tools to predict the protein-ligand interactions for the over 1 million compounds in our internal, non-partnered chemical library. Now, less than one quarter after the closing of these acquisitions, we worked with our partners at NVIDIA to predict the protein-ligand interactions of approximately 36 billion compounds in the Enamine REAL Space, reported to be the world’s largest searchable chemical library.
◦Accelerating Pipeline and Partnership Value: For our internal pipeline, we have used our digital chemistry tools to deconvolve proteome-wide biological targets to confirm that certain compounds operate through a novel mechanism of action which was previously predicted by our functional phenomics maps. Such proteomic mapping capabilities provide an additional data layer to efficiently identify the most promising novel chemical series.
◦Foundation Model Construction: We continue to use our supercomputer, BioHive-1, to train a proprietary phenomics foundation model. As we have trained on larger quantities of our proprietary data, emergent properties have arisen out of the models and we have seen significant improvements over previous deep learning production models. We are also in the early stages of exploring more powerful and broadly useful foundation models based on our large-scale proprietary multi-omics data, which includes phenomics across 50 human cell types and approximately 1.7 million compounds, multi-timepoint live-cell microscopy, transcriptomics, proteomics, inVivomics, multi-target compound interactions, physicochemical properties, as well as predicted protein-ligand relationships. We may explore commercial licensing of some of our models in collaboration with NVIDIA and their BioNeMo platform in the coming year, though our state-of-the-art models will only be available to our team and close partners.
◦Large Language Models: One year ago, more than 40 employees were dedicated to exploring our maps of biology and chemistry to initiate programs at Recursion. Today, those same employees have been redeployed and our newest internal programs are being initiated autonomously. This efficiency and scale is through the deployment of large language models to map scientific literature in conjunction with our internally derived proprietary maps to identify opportunities for scientific arbitrage in areas of unmet need. These opportunities are then automatically prioritized for confirmation and validation in our highly-automated wetlabs. This is a significant step towards our vision of autonomous drug discovery and biological exploration.
◦Valence Labs – Powered by Recursion: In July 2023 at the International Conference for Machine Learning, we launched Valence Labs, Recursion’s cutting-edge machine learning research center for biology and chemistry in Montréal that aims to promote open-science and academic research. Recursion’s

commitment to open-science helps us recruit and retain the best talent in the field of generative AI, allows us to design and set the standards by which ML and AI are deployed in drug discovery, and may drive additional biopharma companies to consider partnering with Recursion to get access to our proprietary state-of-the-art tools, technology, datasets and programs.

Additional Corporate Updates
•Chief Medical Officer: In May 2023, David Mauro, M.D., Ph.D. joined Recursion as its Chief Medical Officer. Dr. Mauro has over 20 years experience in oncology drug development and has guided more than 25 Investigational New Drug candidates through the translational, preliminary and later stages of development at various companies.
•Chief Legal Officer: In July 2023, Recursion named Nathan Hatfield, J.D., M.B.A. as Chief Legal Officer. Mr. Hatfield has worked at Recursion for over 6 years, previously serving as SVP and Head of Legal. Prior to Recursion, Mr. Hatfield was a securities attorney at the law firm Wilson Sonsini Goodrich & Rosati.
•Toronto Office: In June 2023, we celebrated the opening of our Canadian Headquarters in Toronto with government officials as well as members of the technology and biotechnology communities.
•ESG Reporting: In June 2023, Recursion received a favorable ESG Risk Rating from Morningstar Sustainalytics which ranked Recursion as the #1 biotechnology company out of approximately 400 companies and the #14 pharmaceuticals company out of approximately 900 companies.

Second Quarter 2023 Financial Results

•Cash Position: Cash and cash equivalents were $405.9 million as of June 30, 2023. This cash position does not include the recent $50 million investment from NVIDIA.
•Revenue: Total revenue was $11.0 million for the second quarter of 2023, compared to $7.7 million for the second quarter of 2022. The increase was due to progress made in our Roche-Genentech collaboration.
•Research and Development Expenses: Research and development expenses were $55.1 million for the second quarter of 2023, compared to $38.4 million for the second quarter of 2022. The increase in research and development expenses was due to increased platform costs as we have expanded and upgraded our capabilities.
•General and Administrative Expenses: General and administrative expenses were $28.3 million for the second quarter of 2023, compared to $21.2 million for the second quarter of 2022. The increase in general and administrative expenses was due to an increase in salaries and wages of $3.0 million and increases in software and depreciation expense.
•Net Loss: Net loss was $76.7 million for the second quarter of 2023, compared to a net loss of $65.6 million for the second quarter of 2022.

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]).

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!

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]).

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!

Recent Business Updates

•
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)

•
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

•
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

•
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

o
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

o
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

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

•
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:

•
Total company revenue of approximately $17 million
•
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:

•
Total company revenue in the range of $70 million to $72 million
•
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
•
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
•
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.