On February 27, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported its financial results for the financial year ended 31 December 2022 (Press release, Telix Pharmaceuticals, FEB 27, 2023, View Source [SID1234627776]). All figures are in AU$ unless otherwise stated.

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2022 HIGHLIGHTS

Total Group revenue $160.1M (2021: $7.6M) commercial launch of Illuccix drives 20x increase in revenue
Highly positive top-line data from Phase III ZIRCON trial of investigational kidney cancer imaging agent TLX250-CDx paves way to commence regulatory filing process for a second imaging agent for the urology field
Advancement across the core therapy pipeline programs, including:
– Patient dosing in ProstACT SELECT and TARGET prostate cancer therapy trials
– Manufacturing scale-up to facilitate commencement of the ProstACT GLOBAL trial in international sites in 2023
– Patients dosed in STARLITE-2 study of therapy candidate TLX250 in patients with advanced clear cell renal cell carcinoma (ccRCC) in combination with immunotherapy
– Final data from IPAX-1, a Phase I/II trial of TLX101, an investigational therapy in patients with recurrent glioblastoma multiforme (GBM), confirmed the study met its primary objectives and demonstrated encouraging preliminary efficacy data
Build out of the radioisotope production facility in Brussels South progressing, on-track to commence operations in 2023
Net loss after tax $104.1M (2021: $80.5M), reflecting a period of investment to scale-up commercial and clinical activities
Adjusted earnings before tax, interest, depreciation and amortisation (Adjusted EBITDA) $(67.8)M (2021: $(76.1)M)
Gross margin (62%) has steadily improved since launch, reflecting efficiency gains in manufacturing of commercial products and scale benefits
Improvement in cash balance and net cash utilisation:
– Cash and cash equivalents of $116.3M as at 31 December 2022 (2021: $22.0M)
– Improved cash balance reflects $175.0M capital raise undertaken in January 2022, cash generation from sales of Illuccix and improved operating expenditure control
– Customer receipts generated cash of $124.1M (2021: $4.2M), reflecting the commencement of commercial sales
Dr Christian Behrenbruch, Group Chief Executive Officer and Managing Director commented on the result:

"This year Telix has demonstrated it can effectively identify, develop and commercialise assets. This included the delivery of a complex Phase III trial and scale-up of the business to support the highly successful launch of our first commercial product, Illuccix. These achievements, along with a continued focus on expenditure control, have seen us finish 2022 in a strong financial position with a healthy cash balance and a growing revenue stream. Our commitment to financial stewardship is enabling us to invest our earnings to fund the late-stage programs in our pipeline, while transitioning to cash flow positive. Ultimately this will deliver further benefits to patients and shareholders.

"Along with the launch of Illuccix, the positive readout of our Phase III ZIRCON study of our kidney cancer imaging agent, TLX250-CDx was a major highlight of 2022. We look forward to building on this strong foundation in 2023 as we prepare regulatory filings for two imaging agents for kidney and brain cancer and continue to advance the late-stage therapy programs in prostate, kidney and brain cancer."

Further details on the Company’s results can be found in the Company’s Appendix 4E, investor presentation slides and 2022 Annual Report lodged with the ASX and also available on the Company’s website.

Investor Call

An investor conference call / webcast will be held on Tuesday 28 February 2023 at 9.00am AEDT (Monday 27 February 2023 at 5.00pm EST).

Participants may register for the call at the following link: View Source

On February 27, 2023 The Hadassah Cancer Research Institute at the Hadassah University Medical Center in Jerusalem, reported that researchers have designed a genomic analysis tool for cancer patients that enables advanced selection of drugs targeting schemes for cancer genes, opening the door to improved personalized medicine in cancer treatment (Press release, Hadassah Medical Center, FEB 27, 2023, View Source [SID1234627775]). The science behind this breakthrough tool is a computational biology method to assess the relative effect of each position-specific point mutation in 535 cancer genes, by quantifying the relative biological and clinical importance of point mutations. This enables the prioritization of genes for targeting and will lead to the development of new, more effective combination therapies, further improving the prognosis for cancer patients.

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A new study led by Dr. Shai Rosenberg, head of HCRI’s Laboratory for Cancer Computational Biology, and by his research student Dr. Jacob Landau, demonstrates the power of shared cancer datasets and computational biology in advancing cancer care toward truly personalized and effective treatments for patients. By quantitatively assessing the relative biological and clinical importance of somatic mutations, gene targeting can be prioritized, maximizing treatment outcomes and reducing the risk of side effects.

"The availability of genomic analysis for cancer patients, coupled with advances in targeted therapies, holds great promise for personalized medicine approaches in cancer treatment," said Dr. Shai Rosenberg. "Our study takes this one step further, by developing a method to assess the relative impact of each somatic mutation bringing us closer to truly personalized care for cancer patients."

"With this new gene targeting tool, we are finally able to bring the power of personalized medicine to the forefront of cancer care. No longer will patients be subjected to treatments that may not be effective for their specific needs, but instead will receive tailored therapy that maximizes their chances for success," said Prof. Michal Lotem, MD, Head of the Hadassah Cancer Research Institute.

"This is a major milestone in the fight against cancer. By allowing us to prioritize and tailor treatment based on a patient’s specific genetic mutations, we have the potential to improve outcomes and change the lives of those affected by this disease," said Prof. Aron Popovtzer, Professor of Radiation Oncology and Head of the Sharett Institute of Oncology.

On February 27, 2023 PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, reported that it will be participating in Cowen’s 43rd Annual Health Care Conference in Boston, Massachusetts (Press release, Pacific Biosciences, FEB 27, 2023, https://www.prnewswire.com/news-releases/pacbio-to-present-at-cowens-43rd-annual-health-care-conference-301756079.html [SID1234627774]).

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PacBio management is scheduled to participate in a fireside chat on Tuesday, March 7th at 12:50 PM ET. Interested parties may access a live and archived webcast of the event at the company’s investors page at investor.pacificbiosciences.com.

On February 27, 2023 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the fourth quarter and full fiscal year ended December 31, 2022 (Press release, ViewRay, FEB 27, 2023, View Source [SID1234627773]).

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Full Year 2022 Highlights

Total revenue of $102.2 million primarily from 16 revenue units including one upgrade, compared to 2021 revenue of approximately $70.1 million, primarily from ten revenue units.
Received a total of 32 orders for the twelve months ended December 31, 2022, totaling $191.0 million, compared to 28 total orders totaling $158.9 million in 2021.
Total backlog increased to approximately $380.2 million as of December 31, 2022, compared to approximately $313.4 million as of December 31, 2021.
Cash and cash equivalents was approximately $142.5 million as of December 31, 2022. Cash usage in 2022 was $91.2 million excluding the term loan net proceeds from the November debt restructuring.
Fourth Quarter 2022 Highlights

Total revenue for the fourth quarter 2022 was approximately $34.7 million, primarily from five revenue units, compared to approximately $20.4 million, primarily from three revenue units, in the fourth quarter of 2021.
Received nine new orders for MRIdian systems totaling approximately $56.4 million, compared to seven new orders totaling approximately $40.7 million in the fourth quarter of 2021.
"Our innovation and clinical pipelines, along with increased market awareness efforts, are driving therapy adoption," said Scott Drake, President and CEO. "Over 29,000 patients have been treated to date, it’s clear that when patients know highly-effective, short-course, virtually side-effect-free therapy is available, they will demand it and travel for it. We focus on our mission of "Treating and proving what others can’t" which position us to drive revenue growth, gross margin expansion, and expense leverage again in 2023."

Financial Results

Total revenue for the three months ended December 31, 2022 was $34.7 million compared to $20.4 million for the same period last year. Total revenue for the full year 2022 was $102.2 million compared to $70.1 million for the full year 2021.

Total cost of revenue for the three months ended December 31, 2022 was $30.3 million compared to $20.6 million for the same period last year. Total cost of revenue was $92.2 million for the full year 2022 compared to $69.8 million for the full year 2021.

Total gross profit for the three months ended December 31, 2022 was $4.4 million, compared to a gross loss of $0.2 million for the same period last year. Total gross profit for the full year 2022 was $10.0 million compared to gross profit of $0.3 million for the full year 2021.

Total operating expenses for the three months ended December 31, 2022 were $30.4 million, compared to $29.0 million for the same period last year. Total operating expenses for the full year 2022 were $117.2 million compared to $104.0 million for the full year 2021.

Net loss for the three months ended December 31, 2022 was $27.8 million, or $(0.15) per share, compared to $27.1 million, or $(0.16) per share, for the same period last year. Net loss for the full year 2022 was $107.3 million, or $(0.59) per share, compared to $110.0 million, or $(0.67) per share, for the full year 2021.

Non-GAAP adjusted EBITDA for the three months ended December 31, 2022 was a loss of $18.4 million, compared to a loss of $24.1 million for the same period last year. Non-GAAP adjusted EBITDA for the full year 2022 was a loss of $78.2 million compared to a loss of $73.7 million for the full year 2021. We define adjusted EBITDA as EBITDA (defined as net income before net interest expense, depreciation, and amortization), adjusted for impairment of assets, non-cash equity-based compensation, non-cash changes in warrant liability valuations, and non-recurring costs. Refer to the schedule below for a reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA.

ViewRay had total cash and cash equivalents of $142.5 million at December 31, 2022.

Financial Guidance

For the full year 2023, ViewRay anticipates total revenue will increase 25% to 40% and Adjusted EBITDA to be in the range of $(70 million) to $(80 million). Our definition of adjusted EBITDA is set forth above. Refer to the schedule below for a reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Monday, February 27, 2023 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in number is (888) 396-8049 and the confirmation number is 47314692. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call.

Use of Non-GAAP Financial Measures

ViewRay reports its financial results in accordance with generally accepted accounting principles in the United States ("GAAP") and the rules of the SEC. To supplement its financial statements prepared and presented in accordance with GAAP, ViewRay uses adjusted EBITDA as a non-GAAP financial measure.

ViewRay has supplemented its GAAP net loss with a non-GAAP measure of adjusted EBITDA. We define adjusted EBITDA as EBITDA (defined as net income before net interest expense, depreciation, and amortization), adjusted for impairment of assets, non-cash equity-based compensation, non-cash changes in warrant liability valuations, and non-recurring costs.

Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the company and facilitates a meaningful comparison of results for current periods with previous operating results. Management uses adjusted EBITDA for both strategic and annual operating planning.

Adjusted EBITDA has important limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Some of these limitations are that Adjusted EBITDA:

does not reflect any charges for the assets being depreciated and amortized that may need to be replaced in the future;
does not reflect the significant interest expense or the cash requirements necessary to service interest or, if any, principal payments on our debt;
does not reflect the impact of write-downs of long-lived assets;
does not reflect the impact of share-based compensation upon our results of operations;
does not reflect the impact of changes in fair value of our warrant liabilities; and
does not include certain expenses that are non-recurring, infrequent and unusual in nature.
A reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA is provided in the schedules below.

On February 27, 2023 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Tuesday, February 28, 2023, at 8:30 a.m. Eastern Time to report its fourth quarter and full-year 2022 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, FEB 27, 2023, View Source [SID1234627772]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.