Ref, Vascepa...excerpt from HLS annual report.
HLS Therapeutics Announces Q4 and Fiscal 2022 Financial Results
TORONTO, March 16, 2023 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focusing on central nervous system ("CNS") and cardiovascular markets, announces its financial results for the three- and twelve-month periods ended December 31, 2022. All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated.
Q4 & FISCAL 2022 FINANCIAL HIGHLIGHTS
• 2022 revenue of $61.5 million, Adjusted EBITDA of $23.8 million and cash-flow from operations of $16.9 million.
• Q4 2022 revenue was $15.7 million, up 4% to $16.4 million measured in constant currency.
• 2022 revenue was $61.5 million, up 5% to $63.0 million measured in constant currency.
• Q4 2022 Vascepa net revenue was C$3.6 million compared to C$2.4 million in Q4 2021, up 51%. In the near-term, Vascepa net revenue growth will trail growth in prescriptions as net pricing adjusts to additional public sector volumes.
• 2022 Vascepa net revenue was C$12.3 million compared to C$7.4 million in 2021; up 67%.
• Q4 2022 Adjusted EBITDA was $5.3 million compared to $6.2 million in Q4 2021.
• 2022 Adjusted EBITDA was $23.8 million compared to $26.3 million in 2021.
• Q4 2022 net loss was ($6.4) million, compared to net loss of ($4.2) million in Q4 2021.
• 2022 net loss was ($23.6) million, compared to net loss of ($13.1) million in 2021.
• Renewed the Company's Normal Course Issuer Bid ("NCIB"). Share repurchases in 2022 totaled $1.0 million.
• Extended and updated certain terms of the credit facility to provide additional capital flexibility.
Q4 & FISCAL 2022 OPERATIONAL HIGHLIGHTS
• 2022 total Vascepa prescription volumes ("TRx") grew 85% year-over-year and grew 22% sequentially in Q4 2022.
• 3,300 physicians have prescribed Vascepa, up 92% year-over-year.
• New Prescriptions ("NRx") increased 124% in Quebec and 67% in Ontario in Q4 2022 following recent public reimbursement listings.
• Expanded access to Vascepa by adding public reimbursement for more than 70% of publicly covered lives in Canada.
• Vascepa remains the fastest growing product amongst its competitive set on a monthly, quarterly and trailing twelve-month basis.
"In 2022, HLS delivered revenue growth with reliable cash flows and Adjusted EBITDA, while increasing investment in sales activities related to Vascepa," said Gilbert Godin, CEO of HLS. "On a constant currency basis, consolidated revenue for 2022 increased 5%, reflecting Vascepa's growing top-line contribution. Vascepa's net revenue grew 67% in 2022, also on a constant currency basis."
"We continue to see growing adoption rates for Vascepa which are reflected in the greater number of physicians and patients who are new to the product, particularly in Quebec and Ontario where Q4 NRx growth rates were 124% and 67%, respectively."
"While claims processing by the Quebec drug plan continues to improve resulting in a higher Vascepa growth rate, prescribers in Ontario are reporting a more burdensome public authorization process. We are working with the province to facilitate and simplify the onboarding of new public plan patients. We are confident this will further improve access for those who are at risk of cardiovascular disease."
"Vascepa is well-positioned with public and private reimbursement in place, standard-of-care endorsements from Canadian medical societies, greater access to physicians and fully operational field personnel. Our focus today is on maximizing access and physician interactions. The steady level of field activity in Q4 lays the groundwork for future adoption as increasing the frequency of calls to relevant physicians is essential to generate trial and adoption."
Mr. Godin continued: "Regarding other products in the portfolio, we have successfully maintained our leadership position for Clozaril in Canada at a time when the mental health settings of care have been under pressure. During this period, Clozaril has continued to generate steady and reliable financial results. In 2022, Clozaril revenue in Canada was essentially level year-over-year (on a constant currency basis) as the market continues to recover from the effect that the pandemic had on access to, and initiation of, refractory schizophrenic treatments. We continued the roll-out of CSAN Pronto and believe it will further strengthen our leadership position with Clozaril."
"And finally, we have met with Health Canada to discuss the positive results of the recent Spanish SECURE trial for Trinomia and expect to refile the product in the second half of this year. Trinomia combines three common medications in one daily pill for patients who have experienced a cardiac event. A polypill such as Trinomia can help improve medication compliance, which is important for reducing the likelihood of a subsequent cardiac event in such patients as evidenced in the Spanish trial."
VASCEPA OUTLOOK
In 2023, HLS expects Vascepa's net revenue to be in a range of C$22-28 million, starting with expected year over year growth of approximately 40-50% in Q1 2023. Growth rates for Vascepa are expected to increase as the year progresses as the frequency of contact with physicians continues and in-line with customary seaso
