(Información remitida por la empresa firmante)
LUND, Sweden, Feb. 23, 2023 /PRNewswire/ —
October-December 2022
Net sales amount kSEK 502 (305) divided by sales of tests kSEK 190 (278) and royalties kSEK 312 (27).
Net earnings amount MSEK -67 (-47) and earnings per share before and after dilution were SEK -2.97 (-2.08).
Cash Flow from operating activities amount MSEK -51 (-50).
Cash and equivalents at the end of the period amounted to MSEK 106 (287).
On October 12, the Company announced a positive update on its physician experience program with IMMray™ PanCan-d. Thus far the program has included 23 high risk surveillance centers around the U.S. thus far and physicians have showed substantial interest in the use of IMMray™ PanCan-d to detect early-stage pancreatic cancer.
On October 17, the Company announced a strategic partnership with Proteomedix to leverage the joint R&D efforts skills of both companies allowing for increased focus on commercialization within Immunovia.
On October 19, the Company announced executive management team changes to accelerate the execution of strategic priorities.
On October 20, the Company announced that the Nomination Committee had been appointed for the 2023 Annual General Meeting and consist of Ranny Davidoff, Carl Borrebaeck, Peter Lindvall and Mats Leifland, who together represent 13.46 percent of the number of shares and votes in the company as of September 30, 2022.
On November 16, it was announced that CEO, Philipp Mathieu, had purchased 150,000 warrants of the 2022/2026 scheme for approximately 297 kSEK.
On November 30, the Company announced that Centers for Medicare & Medicaid Services finalized its payment determination and had set a rate of $897 for Immunovia’s IMMray™ Pan- Can-d test.
On December 5, the Company announced that its U.S. subsidiary, Immunovia Inc., had appointed Jon Hager as new National Sales Director.
Significant events after the period
On January 17, the Company appointed Lara E. Sucheston-Campbell as Head of Clinical and Medical Affairs to Accelerate Commercial strategy of IMMray™ PanCan-d test in the US market.
On January 19, the Company informed about the realignment of the Swedish operations and that a union consultation process had been initiated with the aim of reducing the number of employees within R&D and Operations in Lund.
On February 8, the Company announced that the consultation process regarding realigning its Swedish operations, announced on 19 January 2023, has been completed.
On February 20, the Company announced a rights issue of approximately SEK 202.2 million and postponed the publication of the quarterly report for the first quarter and the annual general meeting.
CEO’s comments
In Q4, Immunovia continued to execute on its unique position as a leader in innovative early detection of pancreatic cancer. Immunovia’s IMMray™ PanCan-d test is the first ever blood test dedicated to early detection of pancreatic cancer, addressing a significant unmet medical need. We reached important milestones in 2022: the first full year that IMMray™ PanCan-d was commercially available in the US, significant progress in driving adoption and important advancements in pursuing reimbursement for our test.
We remain committed to changing the paradigm for early diagnosis of pancreatic cancer by further advancing and improving our commercial and operational capabilities in the US market to ultimately increase the survival rates for one of the deadliest types of cancer.
Looking back at 2022, our team delivered on all our strategic priorities and built out the commercial team supporting a successful product launch in the US, which is our core market. Our commercial teams’ expansion included the addition of Jeff Borcherding, who joined Immunovia in April as the CEO of our US business and brings extensive experience in growing diagnostic businesses from a broad range of commercial leadership roles in the US market. We made additional key recruitments including a new Head of Market Access as well as a Head of Clinical and Medical Affairs more recently. Our expanding commercial team will broaden the market access to IMMray™ PanCan-d and ensure its affordability for as many individuals as possible.
We are focused on ensuring as many patients as possible can benefit from our test. Enabling patient access to our test by broadly rolling it out and securing reimbursement are key in this mission. We are actively pursuing reimbursement for our test with both private, commercial insurances as well as public healthcare insurance schemes in the US. Attaining reimbursement for our test requires both regulatory steps (such as obtaining the required approvals for our laboratory, a unique identifier code etc.) as well as technology validation, demonstrating clinical utility and ensuring physician advocacy for our test with insurances. We have made significant progress on all those aspects over the last year and are currently in advanced reimbursement discussions with various health insurances.
Progress over the past year included receiving Clinical and Public Health Laboratory licenses in all except one state in the US. As of today, only the license in New York state is outstanding, which we are aiming to secure. Licenses enable physicians in a particular state to order the IMMray™ PanCan-d test for their patients and are an important step towards increasing the availability and adoption of our test.
In March, our laboratory in Marlborough, Massachusetts, received accreditation from the College of American Pathologists. In June, we received approval for a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code from the American Medical Association (AMA) for the IMMray™ PanCan-d test. The PLA code became effective on October 1, 2022. CPT codes are the most widely accepted medical nomenclature used in the US to report physician and healthcare professional services, including laboratory tests under public and private health insurance programs and are a necessary and important step on the path towards reimbursement.
Following the approval of the PLA code, we entered the process with the Centers for Medicare & Medicaid Services (CMS) to obtain a payment determination for our test. In November, we received the final payment determination at a rate of $897 from CMS for our IMMray™ PanCan-d test which brings us one step closer to reimbursement. CMS’ payment determination not only appropriately values our test at an attractive rate for Immunovia but also serves as a price reference point in future pricing discussions with commercial payers. Our test has now been included in the 2023 CMS Clinical Lab Fee Schedule at that price, which became active at the beginning of 2023. This price level highlights the value of the market niche Immunovia is targeting and was a welcome approval.
In our mission to drive patient access and physician advocacy for our test during 2022 Immunovia also continued to drive adoption and familiarity with IMMray™ PanCan-d amongst physicians by conducting a physician experience program. The program was designed for providers to gain clinical experience using the IMMray™ PanCan-d test and to collect additional data supporting clinical utility of our test. Feedback from participating physicians suggests IMMray™ PanCan-d is an important test for the early detection of pancreatic cancer that could be integrated into regular patient care. The program included twenty-three high risk surveillance centers around the U.S.
(CONTINUA)