Aankondiging • May 16
HLS Therapeutics Inc. Reaffirms Consolidated Earnings Guidance for the Full Year 2026 HLS Therapeutics Inc. reaffirmed consolidated earnings guidance for the full year 2026. for the year, the company expects consolidated revenue of $56 million-$60 million, representing mid-single-digit percentage growth. Aankondiging • May 01
HLS Therapeutics Inc. to Report Q1, 2026 Results on May 15, 2026 HLS Therapeutics Inc. announced that they will report Q1, 2026 results on May 15, 2026 Aankondiging • Apr 28
HLS Therapeutics Inc., Annual General Meeting, Jun 26, 2026 HLS Therapeutics Inc., Annual General Meeting, Jun 26, 2026. Aankondiging • Mar 13
HLS Therapeutics Inc. Provides Earnings Guidance for the Year 2026 HLS Therapeutics Inc. provided earnings guidance for the year 2026. For the year, company expected Consolidated revenue to be in range of $56 Million to $60 million, representing mid-single-digit percentage growth. Aankondiging • Mar 06
HLS Therapeutics Inc Announces Nilemdo Is Now Available In Canada For The Reduction Of LDL-Cholesterol In Patients At Risk Of Cardiovascular Disease HLS Therapeutics Inc. had announced the commercial launch of NILEMDO (bempedoic acid) in Canada. NILEMDO is now available by prescription nationally. HLS in-licensed the exclusive rights to NILEMDO and NEXLIZET (bempedoic acid and ezetimibe) for the Canadian market from Esperion Therapeutics Inc. in May 2025. Health Canada approved NILEMDO in November 2025. NILEMDO is indicated to reduce LDL-C and the risk of major cardiovascular events in adults who require additional low-density lipoprotein cholesterol (LDL-C) lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. Cardiovascular disease is the second leading cause of death in Canada, yet many high-risk patients still cannot achieve guideline-recommended LDL-C targets. HLS estimates that more than half a million Canadians may benefit from NILEMDO. NILEMDO provides a novel, oral pathway for LDL-C lowering while being less likely to cause muscle-related side effects that limit statin adherence for many patients. In clinical practice, physicians typically initiate therapy with a statin, then add ezetimibe if additional LDL-C lowering is needed. NILEMDO fits directly into this established treatment paradigm, providing a meaningful step-up option for patients who remain above their LDL-C target on combination therapy or who cannot tolerate adequate statin doses. NILEMDO can be used alone or in combination with other LDL-lowering agents, including statins, ezetimibe, and PCSK9 inhibitors. The approval of NILEMDO is supported by the CLEAR Outcomes trial, a landmark randomized, double-blind cardiovascular outcomes study in nearly 14,000 patients with high cardiovascular risk who were unable to take recommended statin therapy. The trial demonstrated that bempedoic acid significantly reduced the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization. Nilemdo has been submitted for reimbursement under private and public plans and is currently under review. HLS is expecting meaningful private payer coverage in Second Quarter and potential for public reimbursement in late 2026. HLS is also advancing its regulatory submission for NEXLIZET (bempedoic acid and ezetimibe), a once-daily combination pill that combines two complementary LDL-lowering mechanisms. NEXLIZET demonstrated approximately 38% LDL-C reduction in clinical trials. HLS is working with its partner Esperion Therapeutics Inc. to respond to Health Canada's outstanding requirements as expeditiously as possible and anticipates a 2027 commercial launch. NILEMDO (bempedoic acid) is a once-daily oral medicine indicated in Canada to reduce LDL-C and the risk of major cardiovascular events in adults who require additional LDL-C lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. NILEMDO is approved and marketed globally, including in the United States (as NEXLETOL) and in Europe, where it has been available since 2020. In Canada, NILEMDO will benefit from eight years of data protection starting from its November 17, 2025, approval date. This period, combined with existing and pending patents, provides market exclusivity for the drug extending until 2040. Aankondiging • Feb 26
HLS Therapeutics Inc. to Report Q4, 2025 Results on Mar 12, 2026 HLS Therapeutics Inc. announced that they will report Q4, 2025 results on Mar 12, 2026 Aankondiging • Nov 19
Esperion Partner Hls Therapeutics Announces Approval of Nilemdo®? for the Reduction Ofdl-Cholesterol in Canadians At Risk of Cardiovascular Disease Esperion Therapeutics Inc. announced that HLS Therapeutics Inc. the Company's partner in Canada for the development and commercialization of NILEMDO®? (bempedoic acid) and NEXLIZET®? (bem Pedoic acid and ezetimibe), has received approval from Health Canada to market NILEMDO for the reduction of LDL-Cholesterol in Canadians at risk of cardiovascular disease. Commercial launch for NILEMDO is expected in second quarter 2026. According to the Government of Canada, approximately one in 12 Canadian adults aged 20 and over, which represents 2.6 million people, are living with diagnosed heart disease. It is the second leading cause of death in Canada, with approximately 14 Canadian adults aged 20 and over dying every hour due to diagnosed heart disease. Aankondiging • Nov 13
HLS Therapeutics Inc. Updates Earnings Guidance for the Full Year 2025 HLS Therapeutics Inc. updated earnings guidance for the full year 2025. For the year, the company expects Consolidated revenue of $55 million-$56 million, consisting of: Vascepa revenue growth in the mid-teen percentages (compared to prior estimate of 18%- 26% growth);Canada Clozaril revenue decline of 4%-5% (compared to prior estimate of flat year-over-year revenue); U.S. Clozaril revenue decline of 2%-4% year-over-year is unchanged; Royalty revenue of $0.6 million-0.75 million (50%-60% decline) is unchanged. Aankondiging • Oct 30
HLS Therapeutics Inc. to Report Q3, 2025 Results on Nov 13, 2025 HLS Therapeutics Inc. announced that they will report Q3, 2025 results at 12:30 PM, US Eastern Standard Time on Nov 13, 2025 Aankondiging • Jul 31
HLS Therapeutics Inc. to Report Q2, 2025 Results on Aug 14, 2025 HLS Therapeutics Inc. announced that they will report Q2, 2025 results on Aug 14, 2025 Aankondiging • Apr 24
HLS Therapeutics Inc. to Report Q1, 2025 Results on May 08, 2025 HLS Therapeutics Inc. announced that they will report Q1, 2025 results on May 08, 2025 Aankondiging • Apr 21
HLS Therapeutics Inc., Annual General Meeting, Jun 20, 2025 HLS Therapeutics Inc., Annual General Meeting, Jun 20, 2025. Aankondiging • Mar 13
HLS Therapeutics Inc Appoints Christine Elliott to its Board of Directors HLS Therapeutics Inc. announced that Christine Elliott has been appointed to the Company's Board of Directors (the "Board"), effective immediately. Ms. Elliott served as Ontario's Deputy Premier and Minister of Health from 2018 to 2022, where she gained significant knowledge of, and experience with, the operation of Ontario's health system. From 2015 to 2018, she was appointed as Ontario's first Patient Ombudsman, advocating for patient rights and healthcare transparency. Prior to that, she was a member of the Ontario legislature from 2006-2015. In addition to her public service, Ms. Elliott currently serves as Counsel in the health group at Fasken Martineau DuMoulin LLP in Toronto. Ms. Elliott holds a Bachelor of Laws degree from Western University. Her dedication to community service is evident through her co-founding of the Abilities Centre in Whitby, Ontario. She has also served on the boards of several organizations, including Durham Mental Health Services, Grandview Children's Centre, and the Lakeridge Health Whitby Foundation. Aankondiging • Feb 27
HLS Therapeutics Inc. to Report Q4, 2024 Results on Mar 13, 2025 HLS Therapeutics Inc. announced that they will report Q4, 2024 results on Mar 13, 2025 Aankondiging • Oct 24
HLS Therapeutics Inc. to Report Q3, 2024 Results on Nov 07, 2024 HLS Therapeutics Inc. announced that they will report Q3, 2024 results on Nov 07, 2024 Aankondiging • Jul 25
HLS Therapeutics Inc. to Report Q2, 2024 Results on Aug 08, 2024 HLS Therapeutics Inc. announced that they will report Q2, 2024 results on Aug 08, 2024 Aankondiging • May 29
HLS Therapeutics Inc. Announces New Study Published on the Impact of Pharmaceutical Support Programs on Persistence with Clozapine Treatment HLS Therapeutics Inc. announced that results from a Quebec-based retrospective study examining the positive impact of pharmaceutical support programs ("PSPs") on persistence with clozapine treatment have been published in the Journal of Clinical Pharmacology and Therapeutics. The publication, titled "The Impact of Pharmaceutical Support Programs on Persistence: Clinical, Human and Economic Impact of Clozapine Support Programs in Quebec, Canada", is based on an 18-month persistence study conducted using data from the Regie de l' Assurance Maladie du Quebec ("RAMQ") for patients who were initiated on clozapine treatment. Clozapine PSPs were created to provide additional services to help health care providers manage patients being treated with clozapine which is the only approved treatment for Treatment-Resistant Schizophrenia ("TRS") in Canada. Approximately 25-30% of people with Schizophrenia have TRS. HLS's branded version of clozapine is CLOZARIL®? and its associated PSP is the CLOZARIL Support and Assistance Network, or CSAN®?. The study highlights that helping patients maintain persistence with Clozapine treatment is a critical success factor for the management of TRS patients, resulting in reduced pain and suffering of the patient, improved treatment benefits, and reduced health care costs. The study found that persistence rates were better when clozapine was paired with a PSP, including a 69% reported persistence rate overall for CSAN, as opposed to a 25% persistence rate without a program. The study also notes that differences in the offerings between PSPs can have an impact on persistence, placing varying demands on the health care system. Aankondiging • May 12
HLS Therapeutics Inc Updates Consolidated Revenue Guidance for the Full Year 2024 HLS Therapeutics Inc. updated consolidated revenue guidance for the full year 2024. for the year, the company is lowering its full year consolidated revenue guidance to a range of $60 million - $62 million from $63.5 million -$66.5 million. Aankondiging • Apr 27
HLS Therapeutics Inc. to Report Q1, 2024 Results on May 09, 2024 HLS Therapeutics Inc. announced that they will report Q1, 2024 results on May 09, 2024 Aankondiging • Apr 09
HLS Therapeutics Inc., Annual General Meeting, Jun 07, 2024 HLS Therapeutics Inc., Annual General Meeting, Jun 07, 2024. Aankondiging • Mar 15
HLS Therapeutics Inc. Provides Consolidated Earnings Guidance for the Fiscal Year 2024 HLS Therapeutics Inc. provided consolidated earnings guidance for the fiscal year 2024. for the year, the company expects consolidated revenue of $63.5 million-66.5 million, or 1%-5% growth. Aankondiging • Mar 01
HLS Therapeutics Inc. to Report Q4, 2023 Results on Mar 14, 2024 HLS Therapeutics Inc. announced that they will report Q4, 2023 results on Mar 14, 2024 Aankondiging • Dec 19
HLS Therapeutics Inc. Announces CFO Changes HLS Therapeutics Inc. announced that Tim Hendrickson is stepping down as CFO to pursue other interests and John Hanna, currently a director of the Company, has been appointed Interim CFO. Mr. Hendrickson will remain in his role until January 26, 2024, to support the transition and the Company will undertake a search for a permanent CFO in the new year. While serving as Interim CFO, Mr. Hanna will remain on the HLS Board as a non-independent director. Mr. Hanna is an accomplished leader with more than 25 years of diverse experience, including in the healthcare industry, as a C-level executive helping companies to drive revenue growth, scale their operations and expand operating profitability. Previously, he served as CFO at Vecima Networks, Inca Networks and eBuyNow and held a variety of senior financial roles with The Westaim Corporation. In addition to being a member of HLS's Board and the Audit Committee, Mr. Hanna has also served as a board member for a number of technology companies. He holds a B.Sc., Biology from University of Victoria, an MBA from the University of British Columbia and is a designated accountant (CPA, CGA). Aankondiging • Nov 15
HLS Therapeutics Inc. Announces Results from New REDUCE-IT Analyses HLS Therapeutics Inc. announced results from new REDUCE-IT analyses adding to the growing body of knowledge on the clinical impact of Vascepa (icosapent ethyl). These new analyses show that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition of Vascepa (icosapent ethyl) significantly reduced the risk of first and total cardiovascular events. This subgroup was almost exclusively comprised of patients with established cardiovascular disease. The results were presented at the American Heart Association ("AHA") Scientific Sessions 2023, which took place November 11 – 13, 2023 in Philadelphia, PA and were simultaneously published in the European Heart Journal Open. It is estimated that 1 in 5 Canadians have Metabolic Syndrome1, a cluster of 3 or more of 5 risk factors: 1) waist circumference =102 cm in men and =88 cm in women, 2) blood pressure =130/85 mmHg, 3) fasting glucose =5.6 mmol/L, 4) triglycerides =1.7 mmol/L, and 5) HDL-C <1.00 mmol/L in men and <1.30 mmol/L in women. Among patients with Metabolic Syndrome but without diabetes at baseline (n=2866), those who were allocated to icosapent ethyl ("IPE") treatment with a median follow-up time of 4.9 years experienced a 29% relative risk reduction for the primary composite endpoint, defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina resulting in hospitalization (P <0.0001) (Absolute Risk Reduction [ARR]=5.9%; number needed to treat [NNT]=17) and a 41% reduction in total (first plus subsequent) events (P <0.0001) compared with placebo. The risk for the key secondary composite endpoint, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was reduced by 20% (P=0.05) and there was a 27% reduction in fatal/nonfatal myocardial infarction (P=0.03), 47% reduction in urgent/emergent revascularization (P <0.0001) and 58% reduction in hospitalization for unstable angina (P <0.0001). Non-statistically significant reductions were observed in cardiac arrest (44%) and sudden cardiac death (34%). The large relative and absolute risk reductions observed supports IPE as an important therapeutic option for patients with metabolic syndrome at high cardiovascular risk, despite lacking robust effects on any metabolic syndrome component. Limitations of these analyses, some of which are exploratory in nature, include the relatively small number of events in certain subgroups or for certain endpoints, such as cardiac arrest and sudden cardiac death. In addition, variation in subjective measures (e.g., waist circumference) may have affected classification of metabolic syndrome. Aankondiging • Oct 27
HLS Therapeutics Inc. to Report Q3, 2023 Results on Nov 09, 2023 HLS Therapeutics Inc. announced that they will report Q3, 2023 results on Nov 09, 2023 Aankondiging • Aug 04
HLS Therapeutics Inc. to Report Q2, 2023 Results on Aug 10, 2023 HLS Therapeutics Inc. announced that they will report Q2, 2023 results on Aug 10, 2023 Aankondiging • Jun 23
HLS Therapeutics Inc. Announces Board Changes HLS Therapeutics Inc. announced that Mr. John Hanna has been appointed to the Board of Directors, while Greg Gubitz, Chair of the Board, is retiring from the Board. John Welborn, a current Board member, has been appointed Chair. These changes are effective immediately. Mr. Hanna is an accomplished leader with more than 25 years of diverse experience, including in the healthcare industry, as a C-level executive helping companies to drive revenue growth, scale their operations and expand operating profitability. Given this experience and background, Mr. Hanna has also been appointed as a member of the HLS Audit Committee.Mr. Hanna is currently Chief Financial Officer of Inca Networks, where he is responsible for the financial direction and strategy of the company. With more than 25 years of experience in operational and corporate finance roles, Mr. Hanna has a proven record of implementing change to generate top-line growth while controlling costs. Previously, Mr. Hanna served as Chief Financial Officer at Vecima Networks and eBuyNow and held a variety of senior financial roles with The Westaim Corporation. Mr. Hanna has also served as a board member for a number of technology companies, including Vector 12 Corporation. He holds an MBA from the University of British Columbia and is a designated accountant (CPA, CGA). Aankondiging • Jun 17
HLS Therapeutics Inc. Elects Christian Roy as Director HLS Therapeutics Inc. announced that at its AGM held on June 16, 2023, the shareholders elected Christian Roy as director. Aankondiging • Jun 09
Hls Therapeutics Inc. Announces Resignation of Director HLS Therapeutics Inc. announced that J. Spencer Lanthier and Don DeGolyer will not be standing for re-election to the HLS board of directors at HLS' upcoming annual meeting of shareholders to be held on June 16, 2023 (the "AGM"). Mr. Lanthier's and Mr. DeGolyer's terms as directors will expire at the conclusion of the AGM. The number of directors to be elected at the AGM will be reduced from ten to eight. Aankondiging • May 04
HLS Therapeutics Inc. to Report Q1, 2023 Results on May 11, 2023 HLS Therapeutics Inc. announced that they will report Q1, 2023 results on May 11, 2023 Aankondiging • Nov 18
HLS Therapeutics Announces Health Canada Approval of PERSERIS® for the Treatment of Schizophrenia HLS Therapeutics Inc. announced that Health Canada has approved the use of PERSERIS® (risperidone for extended-release injectable suspension), 90 mg and 120 mg subcutaneous injection, a novel long-acting injectable of risperidone, for the treatment of schizophrenia in adults. HLS has in-licensed the exclusive rights to PERSERIS for the Canadian market from Indivior PLC (LON: INDV). Risperidone is a well-established treatment for schizophrenia, and PERSERIS delivers its active ingredient, risperidone, in an extended-release delivery system with no loading doses or oral supplementation recommended. Sustained therapeutic levels of risperidone are released over a one-month period from a single injection. Aankondiging • Nov 17
HLS Therapeutics Inc. Reports on Presentation of Reduce-It® Coronary Artery Bypass Grafting Analysis At the American Heart Association HLS Therapeutics Inc. reported on the presentation of REDUCE-IT® Coronary Artery Bypass Grafting ("CABG") analysis at the American Heart Association's ("AHA") Virtual Scientific Sessions 2020, being held virtually from November 13-17, 2020, adding to the growing body of knowledge on the clinical impact of VASCEPA® (icosapent ethyl). These new analyses were presented by Subodh Verma, M.D., Ph.D., a cardiac surgeon and Professor at the University of Toronto, Toronto, Ontario, Canada. The REDUCE-IT CABG analysis looked at 1,837 (22.5%) of the patients enrolled in REDUCE-IT1, representing all patients who had undergone a prior CABG procedure, a common form of surgical intervention to help treat coronary heart disease. Baseline characteristics were similar among patients randomized to VASCEPA versus placebo. Post hoc exploratory analyses of this subgroup showed that, for the composite endpoint of 5-point MACE, which was the prespecified primary endpoint for the full REDUCE-IT study cohort, time to first event for Vascepa was significantly better than placebo by 24% (p=0.004) and total (first and subsequent) events were also better by 36% (p=0.0002). For the REDUCE-IT study's key secondary composite endpoint of 3-point MACE, time to first event was better than placebo by 31% (p=0.001) in the subgroup of patients with a prior CABG. Coronary revascularization procedures, such as CABG, are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, inevitably result in additional time spent in a healthcare setting. REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, therefore these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization. These REDUCE-IT CABG results follow multiple scientific presentations of analysis results from other important patient subgroups in the REDUCE-IT study, including REDUCE-IT REVASC2 and REDUCE-IT PCI. Aankondiging • Oct 28
HLS Therapeutics Inc. to Report Q3, 2020 Results on Nov 05, 2020 HLS Therapeutics Inc. announced that they will report Q3, 2020 results at 6:30 AM, Eastern Daylight on Nov 05, 2020 Aankondiging • Aug 07
HLS Therapeutics Announces Executive Changes HLS Therapeutics Inc. announced that President and COO Gilbert Godin has been appointed to succeed CEO Greg Gubitz who will retire on October 1, 2020. Mr. Godin and Mr. Gubitz were both co-founders of the business in 2014 and have together led the business through its formation and expansion phases. Mr. Gubitz will remain a Board Member of HLS and will work with Mr. Godin through a transition period to ensure an orderly handover. In connection with his appointment as CEO, Mr. Godin will become a member of the Company's Board of Directors. As part of the transition, HLS will conduct a search for a new Chief Operating Officer. Aankondiging • Jul 31
HLS Therapeutics Inc. to Report Q2, 2020 Results on Aug 06, 2020 HLS Therapeutics Inc. announced that they will report Q2, 2020 results at 6:30 AM, US Eastern Standard Time on Aug 06, 2020