On February 28, 2023 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported business highlights and reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, NGM Biopharmaceuticals, FEB 28, 2023, View Source [SID1234627867]).

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"In 2022, NGM Bio further focused our clinical development efforts on our portfolio of clinical-stage solid tumor oncology programs, while continuing the efforts of our prolific drug discovery engine to produce potential next-generation biologic therapeutics." said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "At year end, we reported promising preliminary data from our first myeloid checkpoint inhibitor program, NGM707, at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress and advanced our other myeloid checkpoint inhibitor programs, NGM438 and NGM831, in their ongoing Phase 1/1b trials in patients with advanced solid tumors."
Key Fourth Quarter and Recent Highlights
Solid Tumor Oncology
•Presented preliminary findings from the Phase 1a monotherapy dose escalation arm of the ongoing Phase 1/2 trial of NGM707, an ILT2/ILT4 antagonist antibody product candidate for the treatment of patients with advanced or metastatic solid tumors, at the 2022 European Society of Medical Oncologists Immuno-Oncology (ESMO I-O) Congress. Preliminary findings indicated that NGM707 was generally well tolerated across all dose levels and demonstrated early signals of anti-tumor activity across multiple tumor types.
•Initiated a Phase 1b cohort of the Phase 1/1b trial evaluating NGM438, a LAIR1 antagonist antibody product candidate, in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors.
Other Programs
•Remained on track for topline data readout of ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated NASH cirrhosis (F4 NASH) in the second quarter of 2023.
•Announced that our Phase 2 CATALINA trial evaluating NGM621, a monoclonal antibody engineered to potently inhibit complement C3, in patients with geographic atrophy (GA) secondary to advanced macular degeneration did not meet its primary endpoint. Merck Sharp & Dohme LLC’s, or Merck’s, option to license NGM621 and its related compounds under our amended and restated research collaboration, product development and license agreement, or the Amended Collaboration Agreement, expired unexercised in January 2023 and the program is now wholly owned by us.
•Presented characterization of our first disclosed preclinical bispecific program, NGM936, a bispecific T cell engager therapeutic candidate for the treatment of hematologic malignancies that targets ILT3 and CD3, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
•Received notification from Merck of its decision to terminate the Phase 2b trial of MK-3655 (NGM313), an agonistic antibody that selectively activates fibroblast growth factor receptor 1c-beta-klotho, for the treatment of patients with NASH and liver fibrosis stage 2 or 3 and our amended and restated research collaboration, product development and license agreement as it relates to the MK-3655 (NGM313) and its

related compounds. Merck’s decision to discontinue the trial was based on its interim analysis of reduction in liver fat at Week 24 and was not related to safety concerns. As a result, in late April 2023, the license rights granted to Merck in 2018 with respect to MK-3655 (NGM313) and its related compounds will revert to us and we will wholly own the program.
•Due to the need to conserve capital and prioritize focused execution, we are actively seeking, or intend to seek, collaboration, out licensing, partnering or other business development arrangements with third-party partners with sufficient resources and relevant domain expertise in the relevant therapeutic area in order to further clinical development of the following programs:
◦NGM621, a product candidate designed for the treatment of patients with GA secondary to advanced macular degeneration;
◦Aldafermin, a product candidate designed for the treatment of patients with NASH and/or diseases related to bile acid dysregulation;
◦MK-3655 (NGM313), a product candidate designed as an insulin sensitizer for the treatment of patients with NASH, once termination of Merck’s license is effective; and
◦NGM936, a product candidate designed for the treatment of patients with AML and multiple myeloma.
Fourth Quarter and Full Year 2022 Financial Results
•NGM Bio reported a net loss of $36.4 million and $162.7 million for the quarter and year ended December 31, 2022, respectively, compared to a net loss of $27.2 million and $120.3 million for the same periods in 2021.
•Related party revenue from our collaboration with Merck under the Amended Collaboration Agreement was $18.2 million and $55.3 million for the quarter and year ended December 31, 2022, respectively, compared to $21.0 million and $77.9 million for the same periods in 2021. Our related party revenue from Merck decreased substantially in 2022 and is expected to be significantly lower from January 1, 2023 through March 31, 2024.
•Research and development (R&D) expenses were $46.7 million and $181.1 million for the quarter and year ended December 31, 2022, respectively, compared to $38.7 million and $161.7 million for the same periods in 2021. R&D expenses increased $8.0 million in the quarter ended December 31, 2022 as compared to the prior year period and $19.4 million in 2022 as compared to 2021 primarily due to costs related to our ongoing clinical trials of NGM707, NGM438, NGM831 and NGM120, our completed Phase 2 trial of NGM621, and personnel-related expenses, partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin.
•General and administrative expenses were $9.8 million and $40.5 million for the quarter and year ended December 31, 2022, respectively, compared to $9.5 million and $36.9 million for the same periods in 2021.
•Cash, cash equivalents and short-term marketable securities were $271.5 million as of December 31, 2022, compared to $366.3 million as of December 31, 2021.

On February 28, 2023 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Nektar Therapeutics, FEB 28, 2023, View Source [SID1234627866]).

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Cash and investments in marketable securities at December 31, 2022, were approximately $505.0 million as compared to $798.8 million at December 31, 2021.

"We are committed to ensuring that our existing cash can support a runway through at least the middle of 2025," said Howard W. Robin, President and CEO of Nektar. "This will enable us to advance our current pipeline to reach value-enhancing milestones. As a result, and as we stated on our analyst call last week, we will be making additional changes at Nektar to significantly reduce operating costs to meet that commitment."

Summary of Financial Results

Revenue in the fourth quarter of 2022 was $22.0 million as compared to $25.0 million in the fourth quarter of 2021. Revenue for the year ended December 31, 2022 was $92.1 million as compared to $101.9 million in 2021. Revenue for 2022 was lower compared to 2021, driven by a decrease in non-cash royalty revenue.

Total operating costs and expenses in the fourth quarter of 2022 were $74.5 million as compared to $137.9 million in the fourth quarter of 2021. Total operating costs and expenses for the full year 2022 were $468.2 million as compared to $548.0 million in 2021. Operating costs and expenses for both the fourth quarter and the full year 2022 decreased as compared to 2021 primarily due to the wind down of the bempegaldesleukin program, partially offset by severance expense and non-cash lease and equipment impairment charges.

R&D expense in the fourth quarter of 2022 was $34.7 million as compared to $99.6 million for the fourth quarter of 2021. R&D expense for the year ended December 31, 2022 was $218.3 million as compared to $400.3 million in 2021. R&D expense decreased for both the fourth quarter and full year 2022 primarily due to the wind down of the bempegaldesleukin program. The clinical trial and related employee compensation costs for the wind down of the bempegaldesleukin program are reported in restructuring, impairment and other costs of terminated program, discussed below.

G&A expense was $21.9 million in the fourth quarter of 2022 and $32.1 million in the fourth quarter of 2021. G&A expense for the full year 2022 was $92.3 million as compared to $122.8 million in 2021. G&A expense decreased for both the fourth quarter and full year 2022 primarily due to the wind down of the bempegaldesleukin program.

Restructuring, impairment and other costs of the terminated program were $11.6 million in the fourth quarter of 2022 and $135.9 million in the full year 2022. The full year 2022 amount includes $65.8 million in non-cash lease and equipment impairment charges, $30.9 million in employee severance expense and $31.7 million for clinical trial and related employee compensation costs for the wind down of the bempegaldesleukin program, as well as $7.5 million in other restructuring costs.

Net loss for the fourth quarter of 2022 was $59.7 million or $0.32 basic and diluted loss per share as compared to a net loss of $145.6 million or $0.79 basic and diluted loss per share in the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $368.2 million or $1.97 basic and diluted loss per share as compared to a net loss of $523.8 million or $2.86 basic and diluted loss per share in 2021.

On February 23, 2023, Nektar announced topline data from a Phase 2 study of rezpegaldesleukin in adults with moderately-to-severely active systemic lupus erythematosus (SLE) (View Source) and conducted a call with analysts and investors.

As a result of this call, Nektar will not host its regular quarterly financial results conference call for the fourth quarter and year-end 2022. Nektar’s Form 10-K for the year ended December 31, 2022 was filed on February 28, 2023.

On February 28, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the fourth quarter and fiscal year ended December 31, 2022 (Press release, NanoString Technologies, FEB 28, 2023, View Source [SID1234627865]).

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"We are thrilled with the momentum that’s building in the spatial biology market. In 2022, we grew spatial biology instrument orders 50% year-on-year, and with approximately $40 million of CosMx orders in backlog, we are well-positioned for strong revenue growth in 2023," said Brad Gray, President and CEO of NanoString. "At the Advances in Genome Biology and Technology (AGBT) conference earlier this month, we wowed researchers with demonstrations of our AtoMx Spatial Informatics Platform and customer-generated data using our new 6,000-plex CosMx RNA panel. We believe that we currently offer researchers the most compelling portfolio of spatial biology solutions, and with CosMx RNA assays that provide 12 times the data of competing platforms, and the only cloud-based spatial informatics suite, our lead is growing."
Fourth Quarter Financial Highlights
•Revenue of $34.4 million
•Spatial biology revenue of $14.8 million
•nCounter revenue, inclusive of all service and other revenue, of $19.6 million
Full Year Financial Highlights
•Revenue of $127.3 million
•Spatial biology revenue of $44.7 million
•nCounter revenue, inclusive of all service and other revenue, of $82.6 million
•Cash, cash equivalents and short-term investments balance of $196.5 million as of December 31, 2022
Spatial Biology
•Generated over 105 new system orders in Q4, including approximately 80 for CosMx and over 25 for GeoMx
•Shipped our first 13 CosMx systems in Q4, generating Q4 revenue of approximately $3 million
•Exited 2022 with over 165 CosMx systems in backlog to be shipped in future periods, representing revenue to be recognized in future periods of approximately $40 million
•Announced and demonstrated expansion of capability of CosMx to 6000-plex RNA at the 2023 AGBT annual conference, representing 12 times the number of data points per cell that can be analyzed as compared to competing spatial imaging platforms
•Entered a collaboration with Weill Cornell Medical to create a Spatial Atlas of Human Anatomy (SAHA), that will create multicellular, single-cell, and sub-cellular maps of 30 non-diseased organs from a healthy and diverse population of adults
•Released CosMx SMI dataset generated from formalin-fixed paraffin-embedded (FFPE) human liver samples. The dataset highlights the data quality of the platform, demonstrating high sensitivity and high specificity capabilities
•Total installed base of our spatial biology platforms of approximately 350, an increase of approximately 37% as compared to 2021
•Total peer-reviewed publications featuring our spatial biology platforms were approximately 195 as of December 31, 2022, representing an increase of approximately 105 publications in the last 12 months
nCounter
•Total installed base of our nCounter platforms of approximately 1,120, an increase of approximately 7% as compared to 2021
•Total peer-reviewed publications featuring nCounter were approximately 6,520 as of December 31, 2022, representing an increase of approximately 1,320 publications in the last 12 months
2023 Outlook
The company, based on its plans and initiatives for 2023, expects to record results approximately as follows:
•Revenue of $170 to $180 million, including spatial biology revenue of $95 to $100 million and nCounter revenue, inclusive of all service and other revenue, of $75 to $80 million
•Adjusted EBITDA loss of $65 to $75 million
Financial Results
We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the tables at the end of this press release.
(dollars in thousands) Three Months Ended December 31,
GAAP Non-GAAP Adjusted
2022 2021 2022 2021
Total revenue $ 34,422 $ 42,455 $ 34,420 $ 42,007
Cost of revenue 21,122 20,046 19,604 19,394
Gross margin 39 % 53 % 43 % 54 %
Research and development 19,086 18,162 14,996 15,693
Selling, general and administrative 36,895 31,596 27,530 26,553
Adjusted EBITDA N / A N / A $ (27,710) $ (19,633)
Non-operating expense, net (1,433) (1,912) (1,433) (1,912)
Net loss $ (44,114) $ (29,261) $ (29,143) $ (21,545)
Years Ended December 31,
GAAP Non-GAAP Adjusted
2022 2021 2022 2021
Total revenue $ 127,262 $ 145,085 $ 126,725 $ 143,957
Cost of revenue 65,475 68,304 60,721 65,502
Gross margin 49 % 53 % 52 % 54 %
Research and development 70,841 69,504 58,968 59,301
Selling, general and administrative 143,129 115,503 115,593 92,985
Adjusted EBITDA N / A N / A $ (108,557) $ (73,831)
Non-operating expense, net (7,360) (7,028) (7,360) (7,028)
Net loss $ (159,543) $ (115,254) $ (115,917) $ (80,859)

Supplemental Information
As a supplement to the table above, we have posted to the investor relations section of our website, at View Source, supplemental financial data that include our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the fourth quarter and full year of 2022 and for each quarter of and the full year of 2021.
Conference Call
Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning February 28, 2023 at 7:30pm ET through midnight ET on March 14, 2023. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 176735. The webcast will also be available on our website for one year following the completion of the call.
Non-GAAP, or Adjusted, Financial Information
We believe that the presentation of non-GAAP, or adjusted, financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Reconciliation of adjusted financial measures to the most directly comparable financial result as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. A reconciliation of adjusted guidance measures to corresponding GAAP measures is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future. For further information regarding why we believe that these adjusted measures provide useful information to investors, the specific manner in which management uses these measures and some of the limitations associated with the use of these measures, please refer to "Notes Regarding Non-GAAP Financial Information" at the end of this press release.

On February 28, 2023 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter ended December 31, 2022 and provided its outlook on business performance for 2023 (Press release, Myriad Genetics, FEB 28, 2023, View Source [SID1234627864]).

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"Myriad Genetics ended 2022 with a strong fourth quarter. Our market-leading hereditary cancer test, MyRisk, achieved double-digit year-over-year growth in the quarter – a reflection of our team’s hard work and the execution of our strategic growth plan," said Paul J. Diaz, president and CEO, Myriad Genetics. "We believe 2023 will be an exciting year as we continue to invest in our Labs of the Future strategy and enabling technologies to enhance our ability to better serve our patients and provider partners. We plan to introduce a number of new products in the second half of 2023, including Precise Liquid and FirstGene. And we are on-track to introduce Precise MRD to our pharma partners for research use." Mr. Diaz concluded, "We remain confident in our ability to achieve our goal of 10%+ annual growth by 2024 based on the progress we made in 2022 and the strong start to the year we are seeing through February. As we look to 2024 and beyond, we are excited about our robust product pipeline and a capital structure that enables Myriad Genetics to invest in future innovation and growth."

Financial and Operational Highlights:
•Diagnostic test volumes of approximately 299,000 in the fourth quarter of 2022 increased 26% year-over-year. Hereditary cancer and pharmacogenomics volumes grew 16% and 23%, respectively, in the fourth quarter of 2022 compared to the fourth quarter of 2021.
•The following table summarizes year-over-year volume changes in the company’s core product categories:
Three months ended December 31, Year ended December 31,

2022 2022
Product volumes:
Hereditary cancer 16 % 1 %
Tumor profiling — % 1 %
Prenatal 40 % 9 %
Pharmacogenomics 23 % 35 %
Total 26 % 14 %

•Fourth quarter revenue of $177.8 million compared to the same period in 2021 was impacted by currency translations of $(3.6) million.
•The following table summarizes year-over-year revenue changes in the company’s core businesses by product category:
Three months ended Twelve months ended
(in millions)
December 31, 2022 December 31, 2021 % Change December 31, 2022 December 31, 2021 % Change
Product revenues:
Hereditary cancer $ 84.9 $ 74.8 14 % $ 305.5 $ 316.3 (3) %
Tumor profiling 31.7 26.5 20 % 128.6 120.9 6 %
Prenatal 29.1 30.1 (3) % 116.4 106.8 9 %
Pharmacogenomics 32.1 29.4 9 % 127.6 93.7 36 %
Total $ 177.8 $ 160.8 11 % $ 678.1 $ 637.7 6 %

•GAAP gross margins of 69.7% in the fourth quarter of 2022 decreased 180 basis points year-over-year, reflecting changes in product/volume mix as well as the impact of currency translation and inflationary pressures.
•GAAP total operating expenses in the fourth quarter of 2022 were $176.1 million, decreasing $18.0 million year-over-year. Adjusted operating expenses in the fourth quarter of 2022 increased $23.3 million year-over-year to $138.6 million, and reflects the incremental investments in research and development, technology and commercial tools, pipeline development and sales and marketing programs, and Gateway Genomics, as well as the impact of the inflationary environment.
•GAAP operating loss in the fourth quarter of 2022 was $52.2 million, increasing $9.1 million year-over-year; adjusted operating loss was $13.9 million, increasing $14.0 million year-over-year from adjusted operating income of $0.1 million in the fourth quarter of 2021.

•Ended the fourth quarter of 2022 with $169.7 million in cash, cash equivalents and marketable investment securities as compared to $257.2 million at the beginning of the quarter. The decrease was driven primarily by the acquisition of Gateway Genomics (closed November 1) and ongoing capital expenditures and investments in the company’s laboratories of the future strategy.
•Cash used in operating activities in the fourth quarter of 2022 was $7.7 million.
•The company ended the quarter with no debt outstanding.

Business Performance and Highlights:

Oncology
The Myriad Genetics Oncology business provides hereditary cancer testing, including the MyRisk hereditary cancer test for patients who have cancer. It also provides tumor profiling products such as the myChoice CDx companion diagnostic test, the Prolaris prostate cancer test, and the EndoPredict breast cancer prognostic test. The Oncology business delivered revenue of $75.9 million in the fourth quarter of 2022.
•Fourth quarter hereditary cancer testing volumes in Oncology grew 13% year-over-year. In addition, Prolaris continued to see strong demand as fourth quarter testing volumes grew 17% year-over-year.
•Researcher enrollment in the first release of Myriad’s Precise treatment registry has already reached approximately 100 individuals, spanning a broad mix of community and academic institutions. Clinicians have access to our cohort browser portal developed in partnership with DNANexus. The portal has already supported multiple collaborative research projects to advance cancer care.
Women’s Health
The Myriad Genetics Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. The Women’s Health business delivered revenue of $69.8 million in the fourth quarter of 2022.
•Fourth quarter hereditary cancer testing volumes in Women’s Health grew 19% year-over-year and were higher than any prior quarter in 2022.
•Fourth quarter results include a partial quarter contribution from the acquisition of Gateway Genomics, a personal genomics company and developer of consumer genetic tests including the No. 1 selling SneakPeek Early Gender DNA Test.
•Excluding the contribution from Gateway Genomics, prenatal testing volumes in the fourth quarter of 2022 grew 2% sequentially versus the third quarter of 2022 and were down 1% versus the fourth quarter of 2021.

•In February, 2023, the Journal of Genetic Counseling, the official journal of the National Society of Genetic Counselors (NSGC), published evidence-based guidelines for expanded carrier screening, which supports the potential increasing adoption and the growth of the company’s carrier screening test, Foresight.

Mental Health
The Myriad Genetics Mental Health business consists of the GeneSight test that covers 64 medications commonly prescribed for depression, anxiety, attention deficit hyperactivity disorder, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, the GeneSight test recorded revenue of $32.1 million in the fourth quarter of 2022.
•GeneSight, under Proprietary Laboratory Analyses (PLA) code 0345U, has been priced on the Medicare Clinical Lab Fee Schedule at $1,336 per test.
•In the fourth quarter, Myriad Genetics added over 3,000 clinicians who ordered GeneSight for the first time.
•The results of the Veterans Affairs research study (PRIME Care) using GeneSight to improve treatment for veterans with depression was identified as a top 10 genomic advancement for 2022 by the Genomic Medicine Working Group of the National Human Genome Research Institute’s (NHGRI) Advisory council. The annual list of the most significant advances and accomplishments in genomic medicine was published by the American Journal of Human Genetics.
Corporate Growth Initiatives Update:
Myriad Genetics continues to execute its commercial and operational growth initiatives, including the enhancement of its core infrastructure to better communicate the company’s differentiated value proposition, remove friction from engagement with healthcare providers and their patients, and gain reimbursement levels that reflect the value of Myriad’s offering. With the ongoing support from partners, Bain Consulting and KPMG, Myriad has been able to speed decision making and increase productivity across the enterprise.

Growth Strategy
In the fourth quarter of 2022, with the help of Bain Consulting, management conducted a strategic review of its current products and product pipeline, markets, competitive positioning and developed a roadmap for all of its products ("Product 360"). The purpose of this review was to gain a more rigorous and data driven "outside in" perspective of the company’s competitiveness and ability to position each product to their full potential. This review sharpened its view on how to better address the needs of its provider partners and patients in Women’s Health, Mental Health and Oncology. In addition, this review highlighted a focus on key patient sub-segments, such as the estimated 13 million women that meet the National Comprehensive Cancer Network (NCCN) guidelines for the company’s market leading hereditary cancer test, MyRisk, as well as opportunities to better position and expand indications for Prolaris and MyChoice.

Commercial
The company continues to implement digital tools and enabling technologies to improve patient, provider, and payer awareness, engagement, ease of use, and overall experience. Myriad Genetics has made significant progress on the following:
•Enhanced corporate web presence to more fully digitize provider, patient and payor engagement.
•Initiated limited launch of the unified ordering portal in early 2023 with roll out planned through 2023.
•Launched first Epic EMR integration with a phased roll out through 2023 and beyond.
•Continued to refine revenue cycle management (RCM) activities that have already seen significant improvement during 2021-2022 to further improve reimbursement of its products.

Operations
Myriad Genetics’ laboratories of the future strategy enters 2023 with significant progress as we establish and move into modern and scalable facilities. This strategy supports the company’s long-term goals to expand laboratory capacity, reduce cost and enhance testing automation. The company remains on-track to substantially complete both new facility construction and related developments and capital expenditure targets in 2023.

Financial Guidance
Below is a table summarizing Myriad Genetics’ fiscal year 2023 financial guidance*:
(in millions, except per share amounts) FY 2023 FY 2023 Comments Q1 2023 Q1 2023 Comments
Revenue $720 – $750 Reflects annual growth of between 6% – 11% over 2022 $170 – $172 Expected to decrease ~3% from Q4 ’22 reflecting seasonality
Gross margin % 68% – 70% GM expected to remain within range given seasonality 68% GM expected to decrease 200 basis points from Q4 ’22 due to seasonality
GAAP OPEX $628 – $648 $165 – $167
Adjusted OPEX $530 – $550 Adjusted operating expenses expected to remain flat-to-down from annualized Q4 ’22 range $138 – $140 Adjusted operating expenses expected to remain flat in nominal dollars compared to Q4 ’22
GAAP EPS $(1.43) – $(1.23) $(0.47) – $(0.45)
Adjusted EPS $(0.40) – $(0.20) Adjusted EPS is expected to improve through 2023, reaching positive adjusted profitability and operating cash flow in Q4 ’23 $(0.20) – $(0.18) Adjusted EPS loss expected to be greater than Q4 ’22 due to ongoing investments combined with seasonality

* Assumes currency rates as of February 28, 2023

Myriad Genetics’ fiscal year 2023 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the estimated impact of stock-based compensation expense of approximately $40.0 million, non-cash amortization associated with acquisitions of approximately $43.0 million and special items such as costs related to transformation initiatives of approximately $15.0 million.
Myriad Genetics’ fiscal first quarter of 2023 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the estimated impact of stock-based compensation expense of approximately $10 million, non-cash amortization associated with acquisitions of approximately $11 million and special items such as costs related to transformation initiatives of approximately $6 million.
These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.
Conference Call and Webcast
A conference call will be held today, Tuesday, February 28, 2023, at 4:30 p.m. EST to discuss Myriad Genetics’ financial results and business developments for the fourth quarter 2022. The dial-in number for domestic callers is 1-800-920-6941. International callers may dial 1-212-231-2939. All callers will be asked to reference reservation number 22025948. An archived replay of the call will be available for seven days by dialing 1-800-257-4607 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

On February 28, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported financial results for the fourth quarter and full year of 2022 along with recent corporate updates (Press release, Mirati, FEB 28, 2023, View Source [SID1234627863]).

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"2022 was a momentous year for Mirati, culminating in the approval and launch of KRAZATI as a treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation. We believe this is the first of several potentially best-in-class products on the horizon for Mirati," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In addition to the approval of KRAZATI in 2022 we advanced MRTX1719 and MRTX0902 into clinical trials and filed an Investigational New Drug application for MRTX1133. These accomplishments bring us closer to realizing our vision to unlock the promise of a life beyond cancer. We look ahead to 2023 with excitement as the company enters a new phase of commercialization from a strong financial position."

Pipeline Updates

Adagrasib (Potent and selective KRASG12C inhibitor)

•In December 2022, the Company announced the U.S. Food and Drug Administration (FDA) granted accelerated approval of KRAZATI (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.

•In December 2022, the Company announced the FDA granted Breakthrough Therapy Designation (BTD) for adagrasib in combination with cetuximab in patients with KRASG12C-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. The New England Journal of Medicine published these findings, which demonstrate promising clinical activity and a favorable tolerability profile. Based on recent FDA discussions, the Company expects to move forward with an application for Accelerated Approval in third-line or later KRASG12C-mutated advanced CRC.

•In December 2022, the Company announced preliminary results from the KRYSTAL-7 Phase 2 study and KRYSTAL-1 Phase 1b cohort evaluating adagrasib concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRASG12C mutation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress. The data demonstrated the combinability of KRAZATI with pembrolizumab as well as initial promising clinical activity.

•In November 2022, the Company announced a clinical study collaboration and supply agreement with Incyte to evaluate the combination of adagrasib and INCB099280, an oral PD1 inhibitor, in patients with KRASG12C-mutant solid tumors.

•In October 2022, the Company announced a clinical collaboration with Aadi Bioscience to evaluate the combination of adagrasib and nab-sirolimus, an mTOR inhibitor complexed with human albumin, in KRASG12C-mutant NSCLC and other solid tumors.
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Sitravatinib (Potent TAM receptor inhibitor)

•The Company expects to provide topline final overall survival results from the global, registration-enabling Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the second quarter of 2023.

MRTX1719 (MTA cooperative PRMT5 inhibitor)

•A Phase 1/2 clinical study to evaluate MRTX1719, an MTA cooperative PRMT5 inhibitor, in patients with solid tumors harboring MTAP-gene deletions is ongoing. The study continues to enroll, and the Company expects to share the initial clinical data in the second half of 2023.

MRTX0902 (Potent SOS1 inhibitor)

•The Company initiated a Phase 1/2 clinical study initially evaluating MRTX0902, a selective KRAS signal modifying SOS1 inhibitor, in an escalating dose cohort as a monotherapy and expects to initiate dose escalation cohorts combining MRTX0902 and adagrasib in the second half of 2023.

MRTX1133 (Potent and selective KRASG12D inhibitor)

•In December 2022, the Company submitted the IND application for MRTX1133, a potent and selective KRASG12D inhibitor, which was cleared by the FDA in January 2023. The Company initiated a Phase 1/2 clinical study in February 2023 with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other tumor types with KRASG12D mutations.

Recent Corporate Updates

•In November 2022, the Company announced the appointment of Alan Sandler, M.D., as Chief Medical Officer and the planned retirement of Charles Baum, M.D., Ph.D., president, founder and head of research and development in the second quarter of 2023.

•The Company published the 2022 Corporate Sustainability Report, the Company’s second annual report, which provides information describing investments and resources based on the biotechnology and pharmaceuticals framework of the Sustainability Accounting Standards Board.

Fourth Quarter and Full-Year 2022 Financial Results

•Cash, cash equivalents, and short-term investments of approximately $1.1 billion as of December 31, 2022.

•Net product revenue for both the fourth quarter 2022 and the twelve months ended December 31, 2022 was $0.7 million and was driven by sales of KRAZATI, which received approval by the FDA and launched commercially in the U.S. in December 2022. There was no product revenue for the same periods in 2021.

•License and collaboration revenue for the fourth quarter 2022 was $0.2 million, compared to $0.3 million for the same period in 2021. License and collaboration revenues for the twelve months ended December 31, 2022 were $11.7 million, primarily driven by milestone payments received from Zai Lab in connection with the initiation of pivotal clinical studies of adagrasib for the first and second indications in the Zai Lab designated territories during 2022. This compares to license and collaboration revenues of $72.1 million for the same period in 2021, primarily driven by $66.6 million of revenue associated with the transfer of the license and know-how of adagrasib as part of our agreement with Zai
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Lab, and a $5.0 million milestone payment from BeiGene, associated with the start of the first pivotal sitravatinib clinical study in the BeiGene designated territories.

•Cost of product revenue for both the fourth quarter 2022 and the twelve months ended December 31, 2022 was $0.6 million and was primarily due to non-recurring, launch-related product distribution costs for KRAZATI following FDA approval in December 2022. There was no cost of product revenue for the same periods in 2021.

•Research and development expenses for the fourth quarter 2022 were $141.2 million, compared to $153.8 million for the same period in 2021. Research and development expenses for the twelve months ended December 31, 2022 were $531.6 million, compared to $508.6 million for the same period in 2021. The decrease in research and development expenses for the fourth quarter 2022 compared to the same period in 2021 was primarily due to the manufacturing costs incurred in 2021 to support our New Drug Application (NDA) and commercial launch, partially offset by an increase in headcount-related costs, including share-based compensation and salaries, due to the growth of our headcount to support our growing portfolio. The increase in research and development expenses for the twelve months ended December 31, 2022 compared to the same period in 2021 was primarily driven by an increase in development costs to advance our preclinical and clinical development programs, and an increase in headcount-related costs, including share-based compensation and salaries, offset primarily by a reduction in manufacturing costs for adagrasib to support our NDA and commercial launch. The Company recognized research and development-related share-based compensation expenses of $36.2 million during the fourth quarter 2022, compared to $21.8 million for the same period in 2021, and $113.5 million during the twelve months ended December 31, 2022, compared to $68.5 million for the same period in 2021.

•Selling, general and administrative expenses for the fourth quarter 2022 were $70.8 million, compared to $43.5 million for the same period in 2021. Selling, general and administrative expenses for the twelve months ended December 31, 2022 were $239.8 million, compared to $136.7 million for the same period in 2021. The increases were primarily due to an increase in headcount-related costs, including share-based compensation and salaries, and commercial readiness costs as we prepared for the commercial launch of KRAZATI. The Company recognized selling, general and administrative-related share-based compensation expenses of $25.4 million in the fourth quarter 2022, compared to $12.1 million for the same period in 2021, and $72.6 million during the twelve months ended December 31, 2022, compared to $45.0 million for the same period in 2021.

•Net loss for the fourth quarter 2022 was $202.5 million, or $3.51 per share basic and diluted, compared to a net loss of $199.6 million, or $3.72 per share basic and diluted for the same period in 2021. Net loss for the twelve months ended December 31, 2022 was $740.9 million, or $13.18 per share basic and diluted, compared to a net loss of $581.8 million, or $11.21 per share basic and diluted for the same period in 2021.

Conference Call Information

There will be a conference call on February 28, 2023 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the fourth quarter and full year of 2022 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: 2312901.

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