Biodesix Announces Second Quarter 2022 Results and Highlights

On August 4, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for second quarter ended June 30, 2022 and provided a corporate update (Press release, Biodesix, AUG 4, 2022, View Source [SID1234617569]).

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"We are thrilled to announce strong growth from our core lung diagnostic testing, with an increase in revenue of 52% over the second quarter of 2021 and 56% over the first quarter of 2022," said Scott Hutton, CEO of Biodesix. "With the recent Medicare coverage of the Nodify CDT test, all five of our core lung diagnostic tests are now covered, which will help drive adoption of the test and improve margins over the long term.

In addition, we announced two exciting corporate arrangements. The first, announced with Royal Phillips, integrates our Nodify Lung tests into its Lung Cancer Orchestrator patient management system to help facilitate digital ordering of the tests following detection of a lung nodule with the ultimate goal of improving patient care and outcomes. The second, announced with Memorial Sloan Kettering Cancer Center and Bio-Rad Laboratories, allows us to leverage the capabilities of these leading organizations to potentially bring new transformative diagnostics to market, including our initial intention to co-develop a molecular minimal residual disease (MRD) test for solid tumors.

Overall, our progress and positive trends in our core lung diagnostics tests in the first half of the year solidifies our confidence in reaffirming our 2022 revenue guidance."

Second Quarter 2022 Financial Results

For the three-month period ended June 30, 2022, as compared to the same period of 2021 (where applicable):

Total revenue of $11.0 million, a decrease of 8%, driven primarily by an anticipated year-over-year decline in COVID-19 diagnostic testing revenue, offset by strong year-over-year growth in core lung diagnostics:
Core lung diagnostic revenue of $7.3 million, reflected a year-over-year increase of 52% that was driven primarily by the increased adoption of Nodify Lung nodule management tests (Nodify CDT & Nodify XL2 tests);
COVID-19 testing revenue of $3.0 million reflected a year-over-year decrease of 51% that was driven by the shift to at-home rapid antigen testing;
BioPharma Services revenue of $0.7 million decreased 29% year-over-year. COVID-related delays in clinical study enrollment and sample shipping logistics have begun to recover but are still impacting timelines for existing and new agreements;
Second quarter 2022 gross margin of $7.0 million, or 64% as a percentage of revenue as compared to 40% in the comparable prior year period primarily driven by the shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
Operating expenses (excluding direct costs and expenses) of $18.6 million, an increase of 21% driven primarily by growth in sales and marketing to drive our growth in core lung diagnostics sales as well as the recent GeneStrat NGS commercial launch;
Includes non-cash stock compensation expense of $1.4 million as compared to $0.5 million;
Net loss of $15.8 million, an increase of 39%, driven primarily by the loss on extinguishment charge resulting from the restructuring of the contingent consideration agreement with Integrated Diagnostics (Indi);
Cash and cash equivalents of $28.7 million, inclusive of $5.1 million in restricted cash, as of June 30;
Raised net proceeds of $27.3 million during the quarter through debt and equity offerings;
Includes principal payment of $3.0 million on the 2021 Term Loan and $2.0 million for scheduled milestone payment in April 2022 to Indi.
2022 Financial Outlook

The Company reaffirms its 2022 financial outlook and expects to generate between $37.5 million and $39.5 million in total revenue in 2022.

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.

Outlook to Present at the H.C. Wainwright 2nd Annual Ophthalmology Conference

On August 4, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics, will present at the H.C. Wainwright 2nd Annual Ophthalmology Conference being held virtually on Wednesday, August 17 (Press release, Outlook Therapeutics, AUG 4, 2022, View Source [SID1234617585]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Wednesday, August 17, 2022, at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

OMEROS CORPORATION TO ANNOUNCE SECOND QUARTER FINANCIAL RESULTS ON AUGUST 9, 2022

On August 4, 2022 Omeros Corporation (NASDAQ: OMER), reported that the company will issue its second quarter financial results for the period ended June 30, 2022, on Tuesday, August 9, 2022, after the market closes (Press release, Omeros, AUG 4, 2022, View Source [SID1234617600]). Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

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Conference Call Details

To access the live conference call via phone, please dial (833) 634-2592 from the United States and Canada or (412) 902-4100 internationally and ask to be placed into the Omeros earnings call. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (877) 344-7529 from the United States, (412) 317-0088 internationally, and (855) 669-9658 from Canada. The replay access code is 4990130.

For online access to the live or subsequently archived webcast of the conference call, go to Omeros’ website at View Source

Regulus Therapeutics Announces Timing for Second Quarter 2022 Financial Results Webcast and Conference Call

On August 4, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it will report its second quarter 2022 financial results on Thursday, August 11, 2022, after the U.S. financial markets close (Press release, Regulus, AUG 4, 2022, View Source [SID1234617617]).

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In connection with the earnings release, Regulus’ management team will host a live conference call and webcast on the same day at 5:00 PM ET, to discuss the Company’s financial results and provide a corporate update. To access the call, please dial (866) 652-5200 (domestic) or (412) 317-6060 and use the conference ID 10168242. To access the telephone replay of the call, dial (877) 344-7529 (domestic) or (412) 317-0088 and refer to the entry replay code 5578933. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

BIO-TECHNE DECLARES DIVIDEND

On August 4, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended June 30, 2022 (Press release, Bio-Techne, AUG 4, 2022, View Source [SID1234617453]). The quarterly dividend will be payable August 29, 2022, to all common shareholders of record on August 15, 2022. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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