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Cleo Diagnostics
Overview
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Over the course of his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding Chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Company Highlights
- Backed by medical professionals and cancer specialists with decades of experience, Cleo Diagnostics has developed a disruptive, accurate and early-stage ovarian cancer detection blood test.
- Cleo targets the CXCL10 novel biomarker, which is now known to be overexpressed in all stages of ovarian cancer.
- Cleo is the result of more than a decade of research at the Hudson Institute of Medical Research, where chief scientist Dr. Andrew Stephens received more than $5 million OCRF & NHMRC funding for development and clinical studies.
- The test is also supported by Professor Tom Jobling, founder of the Ovarian Cancer Foundation and Lucinda Nolan, the foundation's former CEO.
- Cleo has developed a staged execution strategy focused on an achievable path to market. This ensures the project, which is currently in its advanced R&D stage, can maximise commercial value for all stakeholders.
Key Technology
Cleo Diagnostics
Developed over the course of a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for the purposes of screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Highlights:
- Readily Accessible: Cleo requires no additional or specialised equipment and can be conducted in any standard pathology lab either on its own or as part of a standard panel of tests ordered by a physician.
- AI-based Risk Assessment: Once the sample has been collected and tested, Cleo leverages a proprietary algorithm to perform a risk evaluation on the patient, determining the likelihood of a cancer diagnosis.
- Intuitive Results: Cleo generates an easy-to-understand post-assessment report which can then be sent to the patient's primary care provider or surgeon for triage.
- High Performance: The Cleo prototype outperforms FDA-cleared predicates and clinical guideline tests in terms of accuracy and specificity.
- Current Roadmap: Cleo plans for the test to be ready for clinical use in a surgical triage setting by 2025, where it will be available initially to one million patients. Target launch dates for recurrence, high-risk screening and mass screening are still to be determined. Additionally, the company has numerous inflection points planned over the next two years:
- Kit Development:
- Internal trial antibody optimisation
- Finalisation of antibody selection for the Cleo test-kit
- Complete re-agent development
- Pre-IDE strategic development
- Manufacturing:
- Establishment and accreditation of ISO13485 quality system
- Manufacturing establishment of Cleo key biomarker
- Manufacturing establishment of Cleo Ovarian Cancer Kit
- Clinical Studies:
- Sign key opinion leaders and trial sites
- Perform and finalise verification of the Cleo kit through clinical studies
- Regulatory Approval:
- FDA Pre-IDE submission
- CE regulatory submissions and approval
- TGA regulatory submission and approval
- FDA submission and approval
- Kit Development:
Management Team
Dr. Richard Allman — Chief Executive Officer and Executive Director
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within a 12-month period. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens — Chief Scientific Officer and Executive Director
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Tom Jobling — Lead Medical Advisor and Non-executive Director
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan — Non-executive Director
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Prior to joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing — Non-executive Chair
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.Medtronic: Managing Her Diabetes 'Runner's High'
Jodie Snavely finds mental relaxation when she's running. And she runs a lot - nearly every day.
Achieving that mental relaxation hasn't always been easy, however. For years, Snavely's type 1 diabetes (T1D) added stress, especially when it came to managing her blood sugar levels. She had to consider how much to eat before a long run, how much insulin to give herself, and how her levels changed during a workout.
"Trying to manage all that myself felt like a lot of guesswork," recalls Snavely, 57, who today has several half-marathons under her belt. "And then after I stopped running, my blood sugar would still go up - sometimes really high."
What is hyperglycemia?
High blood sugar, called hyperglycemia, occurs in people with diabetes when there is not enough insulin to regulate the amount of glucose in the blood. This can happen for several reasons, including not taking enough insulin after a meal, fluctuating hormones during monthly menstrual cycles, stress or illness, or dawn phenomenon (when individuals experience a rise in blood sugars in the early morning). Short-term effects include frequent urination, thirst, and fatigue.
When she experiences high blood sugar, Snavely recognizes it right away. "I feel sluggish with slight flu-like symptoms - just yucky and not as clear of mind."
If left untreated, hyperglycemia can lead to serious health complications such as nerve damage, heart disease, kidney damage, and can even impact cognitive function.
High-tech to reduce highs
Some people who live with type 1 diabetes use exercise to help manage high blood sugars. But advances in technology have improved diabetes management in a more predictable way, allowing individuals to track their blood sugar levels closely and make necessary adjustments to their diet and medication.
Snavely relies on the newest technology to help keep highs in check: the MiniMedTM 780G system with Meal DetectionTM technology, which automatically adjusts and corrects sugar levels every five minutes. The device has been instrumental in preventing the blood sugar spikes she experienced after longer runs.
When she miscalculates how many carbohydrates she's eaten, the system keeps her sugar levels where she wants them. As a result, she spends less time thinking and worrying about how her diabetes is affecting her life and her runs.
"My device helps me relax my mind and makes me not worry about ‘Did I give myself too much insulin?' or ‘Did I not give enough?'" said Snavely. "Now I don't have those spikes up and spikes down. My blood sugar levels are more even."
That peace of mind enables the mental relaxation Snavely enjoys most during long-distance runs. And all those runs keep her feeling healthy - that matters to her. Her grandfather, who also had diabetes, died at age 51. She's now 57, and plans for a long life.
"I love that when I'm running, I'm keeping myself healthy for as long as I possibly can. I'm not going to let diabetes take me down."
To learn more about Medtronic, click here.
Important Safety Information: MiniMed™ 780G System With SmartGuard™ Technology With Guardian™ 4 Sensor
The MiniMed™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 780G system includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.
The Medtronic MiniMed™ 780G system consists of the following devices: MiniMed™ 780G insulin pump, the Guardian™ 4 transmitter, the Guardian™ 4 sensor, One-press serter, the Accu-Chek™ Guide Link blood glucose meter, and the Accu-Chek™ Guide test strips. The system requires a prescription from a healthcare professional.
The Guardian™ 4 sensor is intended for use with the MiniMed™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian™ 4 sensor is indicated for up to seven days of continuous use.
The Guardian™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ 4 sensor. The Guardian™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.
WARNING: Do not use the SmartGuard™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard™ feature.
WARNING: Do not use the MiniMed™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 780G system.
WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.
Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library
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Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
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Medtronic to announce financial results for its fourth quarter and full fiscal year 2024
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2024 on Thursday, May 23, 2024 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2024, which ended on Friday, April 26, 2024 .
Medtronic will host a video webcast at 7:00 a.m. CDT on Thursday , May 23, 2024, to discuss results for its fourth quarter and full fiscal year 2024. The webcast can be accessed at https://investorrelations.medtronic.com .
Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Events link at https://investorrelations.medtronic.com .
Looking ahead, Medtronic plans to report its first, second, third, and fourth quarter fiscal year 2025 results on Tuesday, August 20, 2024 , Tuesday, November 19, 2024 , Tuesday, February 18, 2025 , and Thursday, May 22, 2025 , respectively. For these events, confirmation and additional details will be provided closer to the specific event.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-to-announce-financial-results-for-its-fourth-quarter-and-full-fiscal-year-2024-302140511.html
SOURCE Medtronic plc
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2024/09/c6482.html
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Salix Pharmaceuticals announces Bellamy Young as Spokesperson for Xifaxan
- Xifaxan is the first and only FDA approved medication for the reduction in risk of OHE recurrence in adults
- Overt Hepatic Encephalopathy is caused by cirrhosis of the liver
- As complications from chronic liver disease increase, recognizing OHE is critical so that patients can work with their healthcare providers to find the right management plan for them
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced award-winning actor, Bellamy Young, as the brand ambassador in a new campaign to raise awareness of Xifaxan, the first and only FDA approved medication to reduce the risk of overt hepatic encephalopathy (OHE) recurrence in adults. Overt hepatic encephalopathy is a complication of cirrhosis that can happen when the liver cannot filter toxins from the blood, and the toxins build up and reach the brain. It is projected that as many as four out of five people with cirrhosis may eventually develop some form of HE
 |  |
"When I first started talking about OHE, the most common response I received from people was ‘I wish I knew', a sentiment that echoed my experience when my father was diagnosed with OHE. We didn't know the symptoms of OHE could persist or that it could worsen over time. But when my dad had OHE we also didn't know as much as we do today, and we didn't have the same management options," said Bellamy Young, whose father suffered from OHE when she was in high school. "I want to help today's patients and caregivers to know more than my family did with my father, and I encourage them to talk to their health care providers about managing the risk of OHE recurrence. I hope people will go to Xifaxan.com to know more."
To kick off the new Xifaxan marketing campaign, Bellamy is sharing her personal OHE story on www.Xifaxan.com/ohe/ and is in a multi-channel advertising campaign that will be seen across digital mediums, including a 60-second TV spot. Bellamy will also be engaging with HCPs, caregivers, and patients to exchange learnings about OHE by chronicling these experiences and sharing insights on her social media handles throughout the year to support others in knowing more about OHE so they can make informed decisions about disease management. As an ambassador, she will be encouraging caregivers to take an active role as a health advocate for their loved ones.
"With patients at the center of all we do, Salix is committed to driving increased conversation and education about OHE to support patients, caregivers, and Healthcare Professionals in finding the right options," said Nicola Kayel, Senior Vice President, GI Marketing, Salix.
About Overt Hepatic Encephalopathy: Overt Hepatic encephalopathy (OHE) is a complication of cirrhosis, a chronic liver disease, which can have various causes. One of the important functions of the liver is to clean the blood. When the liver is damaged, it can no longer properly clean toxins (like ammonia) from the blood. This buildup of toxins can reach the brain, potentially causing OHE and worsening brain function. Symptoms of OHE can be both physical and mental. Medications and appropriate lifestyle management, with the help of a doctor, may help manage the disease.
Symptoms of Overt Hepatic Encephalopathy may include:
Mental:
- Lack of energy or interest
- Confusion
- Not knowing where you are or where you're going
- Inappropriate behavior
- Severe personality changes
Physical:
- Sleepiness or change in sleep patterns
- Worsening of handwriting
- Loss of small hand movements
- Tremors or shaking of hands or arms
- Breath with a musty or sweet odor
ABOUT XIFAXAN
INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
IMPORTANT SAFETY INFORMATION
- XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
- If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
- Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
- Tell your healthcare provider if you are taking drugs called P-glycoprotein and/or OATPs inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
- In clinical studies, the most common side effects for XIFAXAN were:
- HE: Peripheral edema (swelling, usually in the ankles or lower limbs), constipation, nausea (feeling sick to your stomach), fatigue (feeling tired), insomnia (trouble sleeping), ascites (a buildup of fluid in the abdomen), dizziness, urinary tract infection, anemia (low red blood cell levels), and itching
- XIFAXAN may affect warfarin activity when taken together. Tell your healthcare provider if you are taking warfarin because the dose of warfarin may need to be adjusted to maintain proper blood-thinning effect.
- If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because XIFAXAN may cause harm to an unborn baby or nursing infant.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Please click here for full Prescribing Information.
About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
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| Investor Contact: | Media Contacts: | |
| Garen Sarafian | Kevin Wiggins | |
| ir@bauschhealth.com | corporate.communications@bauschhealth.com | |
| (877) 281-6642 (toll-free) | (908) 541-3785 |
SOURCE: Salix Pharmaceuticals
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Knight Therapeutics Reports First Quarter 2024 Results
Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2024. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.
2024 Highlights
Financial results
- Revenues were $86,604, an increase of $4,007 or 5% over the same period in prior year driven by the growth of our key promoted products offset by our mature branded generic products.
- Gross margin was $41,699 or 48% compared to $40,762 or 49% in the same period in prior year.
- Adjusted EBITDA 1 was $13,589, a decrease of $4,648 or 25% over the same period in prior year reflecting higher marketing spend for the launches of Imvexxy ® , Bijuva ® and Minjuvi ® as well as development costs on our pipeline products.
- Adjusted EBITDA per share 1 was $0.13, a decrease of $0.04 or 24% over the same period in prior year.
- Net loss on financial assets measured at fair value through profit or loss was $16,267 driven mainly by unrealized losses on the valuation of certain private investments in our strategic funds.
- Net loss was $4,546, compared to $3,937 in the same period in prior year.
- Cash inflow from operations was $30,881, an increase of $26,565 or 616% over the same period in prior year driven by operating results and a decrease in working capital.
Corporate developments
- Promoted Henrique Dias and Melanie Groleau to Global VP Marketing and Global VP Medical and Clinical, respectively.
Products
- In-licensed IPX203 (carbidopa and levodopa extended-release capsules) for Canada and Latin America.
- Submitted fostamatinib for ANVISA approval in Brazil.
- Obtained regulatory approval for Karfib ® (carfilzomib) in Colombia.
- Launched Minjuvi ® (tafasitamab) in Brazil.
- Launched Imvexxy ® (estradiol vaginal inserts) and Bijuva ® (estradiol and progesterone) in Canada.
Subsequent to quarter-end
- Entered into exclusive supply and distribution agreement for JORNAY PM ® (methylphenidate HCI extended-release capsules) for Canada and Latin America.
- Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy, and Janice Murray on the Board of Directors.
"I am pleased to report that for the three months ended March 31, 2024, revenues were over $86 million, a growth of 5% over the same period prior year. In addition, we are investing for the future growth of our portfolio with the launch of three products and the in-licensing of two products for Canada and Latin America. We launched Bijuva ® and Imvexxy ® in Canada and Minjuvi ® in Brazil. Furthermore, we have strengthened our neurology portfolio with the addition of Qelbree TM , IPX203 and JORNAY PM ® and will be leveraging our infrastructure behind Exelon ® ," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.
| SELECTED FINANCIAL RESULTS REPORTED UNDER IFRS [In thousands of Canadian dollars] | |||||||||
| Change | |||||||||
| Q1-24 | Q1-23 | $ 1 | % 2 | ||||||
| Revenues | 86,604 | 82,597 | 4,007 | 5 | % | ||||
| Gross margin | 41,699 | 40,762 | 937 | 2 | % | ||||
| Gross margin % | 48 | % | 49 | % | |||||
| Selling and marketing | 12,649 | 10,665 | (1,984 | ) | 19 | % | |||
| General and administrative | 10,538 | 9,106 | (1,432 | ) | 16 | % | |||
| Research and development | 4,980 | 4,187 | (793 | ) | 19 | % | |||
| Amortization of intangible assets | 10,872 | 11,171 | 299 | 3 | % | ||||
| Operating expenses | 39,039 | 35,129 | (3,910 | ) | 11 | % | |||
| Net loss | (4,546 | ) | (3,937 | ) | (609 | ) | 15 | % | |
| 1 | A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss). |
| 2 | Percentage change is presented in absolute values. |
| SELECTED FINANCIAL RESULTS EXCLUDING IAS 29 1 [In thousands of Canadian dollars] | ||||||||||
| Q1-24 | Q1-23 | Change | ||||||||
| $ 2 | % 3 | |||||||||
| Revenues | 85,795 | 82,667 | 3,128 | 4 | % | |||||
| Gross margin | 40,695 | 41,386 | (691 | ) | 2 | % | ||||
| Gross margin (%) | 47 | % | 50 | % | ||||||
| Selling and marketing | 12,493 | 10,713 | (1,780 | ) | 17 | % | ||||
| General and administrative | 10,212 | 8,887 | (1,325 | ) | 15 | % | ||||
| Research and development | 4,840 | 4,102 | (738 | ) | 18 | % | ||||
| Amortization of intangible assets | 10,846 | 11,125 | 279 | 3 | % | |||||
| Operating expenses | 38,391 | 34,827 | (3,564 | ) | 10 | % | ||||
| EBITDA 1 | 13,589 | 18,237 | (4,648 | ) | 25 | % | ||||
| Adjusted EBITDA 1 | 13,589 | 18,237 | (4,648 | ) | 25 | % | ||||
| Adjusted EBITDA per share 1 | 0.13 | 0.17 | (0.04 | ) | 24 | % | ||||
| 1 | Financial results excluding the impact of IAS 29, EBITDA, adjusted EBITDA and adjusted EBITDA per share are non-GAAP measures. Refer to section "Non-GAAP measures" for additional details. |
| 2 | A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss). |
| 3 | Percentage change is presented in absolute values. |
Revenues
For the quarter ended March 31, 2024, revenues were $85,795, an increase of $3,128 or 4% mainly driven by a growth of $7,163 or 13% from our promoted innovative products offset by the decline on our mature branded generic portfolio. The table below provides revenues by therapeutic area.
| Excluding impact of IAS 29 3 | |||||||
| Change | |||||||
| Therapeutic Area | Q1-24 | Q1-23 | $ 1 | % 2 | |||
| Oncology/Hematology | 30,843 | 29,093 | 1,750 | 6 | % | ||
| Infectious Diseases | 38,062 | 30,896 | 7,166 | 23 | % | ||
| Other Specialty | 16,890 | 22,678 | (5,788 | ) | 26 | % | |
| Total | 85,795 | 82,667 | 3,128 | 4 | % | ||
| 1 | A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss). |
| 2 | Percentage change is presented in absolute values. |
| 3 | Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details. |
The increase in revenues excluding the impact of hyperinflation is explained by the following:
- Oncology/Hematology : The oncology/hematology portfolio grew by approximately $4,600 primarily due to the growth of key promoted products including Lenvima ® , Trelstar ® , Akynzeo ® and Palbocil ® as well due to the launch of Minjuvi ® in Brazil. The increase is offset by a reduction of approximately $2,850 in revenues of our mature and branded generics products due to their lifecycle including the entrance of new competitors.
- Infectious Diseases : The infectious disease portfolio grew by $7,166 driven by the growth of our key promoted products including AmBisome ® and Cresemba ® partly offset by the timing of demand for certain products including Impavido ® . The increase included $6,800 of incremental revenues related to the contract with MOH for AmBisome ® .
MOH Contract : The Company signed a contract with the Ministry of Health of Brazil for AmBisome ® in December 2022 ("2022 MOH Contract"). Knight delivered a total of $34,600 under the MOH Contract as follows: $7,000 in 2022, $25,200 in 2023 ($2,400 in Q1-23, $18,000 in Q2-23 and $4,800 in Q4-23) and $2,400 in Q1-24. In December 2023, Knight signed a new contract with the MOH ("2024 MOH Contract") and it is expected that $16,500 will be delivered in 2024 of which $6,800 was delivered in Q1-24. The total MOH sales for AmBisome ® delivered in Q1-24 was $9,200.
- Other Specialty : The Other Specialty portfolio decreased by approximately $5,788 mainly due to advance purchases of Exelon ® in Q1-23, due to the commercial transition from Novartis to Knight in certain countries as well as the purchasing patterns for certain products.
Gross margin
For the quarter ended March 31, 2024, gross margin, as a percentage of revenues, was 48% compared to 49% in Q1-23. Excluding IAS 29, gross margin, as a percentage of revenues, was 47% in Q1-24 and 50% in Q1-23. The decrease in gross margin, as a percentage of revenues was due to product mix.
Selling and marketing ("S&M") expenses: For the quarter ended March 31, 2024, S&M expenses were $12,649, an increase of $1,984 or 19%, compared to the same period in prior year. Excluding the impact of IAS 29, the increase was $1,780 or 17%. The increase was mainly due to the marketing spend for the launches of Imvexxy ® and Bijuva ® in Canada as well as Minjuvi ® in Brazil.
General and administrative ("G&A") expenses: For the quarter ended March 31, 2024, G&A expenses were $10,538 an increase of $1,432 or 16%, compared to the same period in prior year. Excluding the impact of IAS 29, G&A expenses increased by $1,325 or 15% driven by increase in structure and compensation expenses.
Research and development ("R&D") expenses: For the quarter ended March 31, 2024, R&D expenses were $4,980, an increase of $793 or 19%, compared to the same period in prior year. Excluding the impact of IAS 29, the increase was $738 or 18%. The increase was driven by an increase in product development activities in connection with our pipeline products and medical initiatives related to key promoted products. Knight invested $587 in Q1-24, an increase of $575 versus the prior year on its pipeline development activities. All costs related to development activities have been expensed which typically include regulatory submissions, analytical method transfers, stability studies and bio equivalence studies.
Adjusted EBITDA 1
For the three-month period ended March 31, 2024, adjusted EBITDA was $13,589, a decrease of $4,648 or 25%. The decrease in adjusted EBITDA was driven by an increase in operating expenses due to investments on new product launches and pipeline.
Net loss
For the quarter ended March 31, 2024, the net loss was $4,546 compared to a net loss of $3,937 for the same period in prior year. The variance mainly resulted from the above-mentioned items and a net loss on the revaluation of financial assets measured at fair value through profit or loss of $16,267 versus a net loss of $11,847 in the same period in prior year mainly driven by unrealized losses in the fair value of financial assets, partly offset by (1) the foreign exchange gain of $1,934 in Q1-24 compared to a foreign exchange gain of $73 in Q1-23, and (2) income tax recovery of $2,598 in Q1-24 and $1,009 in Q1-23 mainly driven by the recognition of certain deferred tax assets due to tax losses generated in certain jurisdictions and timing differences related to our financial assets.
| SELECTED BALANCE SHEET ITEMS [In thousands of Canadian dollars] | ||||||
| Change | ||||||
| March 31, 2024 | December 31, 2023 | $ | % 1 | |||
| Cash, cash equivalents and marketable securities | 181,859 | 161,825 | 20,034 | 12 | % | |
| Trade and other receivables | 136,580 | 141,684 | (5,104 | ) | 4 | % |
| Inventories | 95,400 | 91,834 | 3,566 | 4 | % | |
| Financial assets | 116,214 | 128,369 | (12,155 | ) | 9 | % |
| Accounts payable and accrued liabilities | 94,711 | 90,617 | 4,094 | 5 | % | |
| Bank loans | 62,241 | 61,866 | 375 | 1 | % | |
| 1 | Percentage change is presented in absolute values. |
Trade and other receivables: As at March 31, 2024, trade and other receivables were at $136,580, a decrease of $5,104 or 4% compared to December 31, 2023, mainly due to the timing of the collection of payments from customers.
Inventories: As at March 31, 2024, inventories were at $95,400, an increase of $3,566 or 4%. Excluding the impact of IAS 29, inventories decreased by $4,192 or 5% driven by the timing of sales and purchases of inventory.
Financial assets: As at March 31, 2024, financial assets were at $116,214, a decrease of $12,155 or 9%, compared to December 31, 2023 mainly driven by unrealized losses on the valuation of certain private investments of our strategic funds.
Accounts payable and accrued liabilities: As at March 31, 2024, accounts payable and accrued liabilities were $94,711, an increase of $4,094 or 5%. In addition, as at December 31, 2023, the accounts payable and accrued liabilities included $5,283 of payables related to sales milestones on certain products and the acquisition of property, plant and equipments ("Capital Expenditure Payables"). Excluding the Capital Expenditure Payables, the accounts payable and accrued liabilities increased by $9,377 or 10% compared to December 31, 2023 driven by the purchase of inventory for our key promoted products which is expected to be settled in Q2-24.
Cash, cash equivalents and marketable securities : As at March 31, 2024, Knight had $181,859 in cash, cash equivalents and marketable securities, an increase of $20,034 or 12% compared to December 31, 2023. The increase is mainly due to cash inflows from operations partially offset by the settlement of upfront and milestone payments in connection with product licensing agreements including Qelbree TM , IPX203, and Cresemba ® . The cash inflows from operating activities were $30,881, driven by the operating results adjusted for noncash items such as depreciation, amortization as well as decrease in working capital of $15,508. The decease in working capital was mainly due to the increase in accounts payable and a decrease in inventory excluding the impact of IAS 29.
| 1 | Adjusted gross margin and adjusted EBITDA is non-GAAP measures. Refer to section "Non-GAAP measures" for additional details. |
Product Updates
Regulatory submissions, approvals and product launches
Fostamatinib
During the quarter, Knight submitted a marketing authorization for regulatory approval in Brazil for fostamatinib for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Karfib ® (carfilzomib)
During the quarter, Knight obtained the regulatory approval for Karfib ® in Colombia for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more previous lines of therapy. Karfib ® is expected to be launched in H2 2024.
Imvexxy ® (estradiol vaginal inserts) and Bijuva ® (estradiol and progesterone)
During the quarter, Knight launched Bijuva ® and Imvexxy ® in Canada. Bijuva ® is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause. Imvexxy ® is indicated for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy ® is competing in the VVA market which was over 90 million dollars in 2023 and grew at a CAGR of 9% since 2020, according to IQVIA.
Minjuvi ® (tafasitamab)
During the quarter, Knight launched Minjuvi ® in Brazil. Minjuvi ® in combination with lenalidomide followed by tafasitamab monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL due to low-grade lymphoma, who are not eligible for autologous stem cell transplantation (ASCT). Knight expects to file for private reimbursement in Brazil in Q2-24 and is expecting to file for private reimbursement in Q2-24.
Expansion of Pipeline
IPX203
During the quarter, Knight in-licensed IPX203 for Canada and Latin America. IPX203 is a novel, oral formulation of carbidopa/levodopa ("CD/LD") extended-release capsules designed for the treatment of Parkinson's disease. IPX203 contains immediate-release (IR) granules and extended-release (ER) coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. IPX203 was studied in the RISE-PD clinical study which was a 20-week, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial with 630 patients. The RISE-PD study met its primary and secondary endpoints and showed that treatment with IPX203 demonstrated statistically significant improvement in daily "Good On" time with fewer doses of IPX203 compared with immediate-release carbidopa-levodopa (least squares mean, 0.53 hours; 95% CI, 0.09-0.97). In that study, IPX203 was dosed an average of three times per day versus 5 times per day for immediate-release carbidopa-levodopa 1 . IPX203 is expected to compete in a market valued at over $50,000 in Canada and over $120,000 in Brazil, according to IQVIA.
Financial Outlook
Knight provides guidance on revenues on a non-GAAP basis. This is due to both the difficulty in predicting Argentinian inflation rates and its IAS 29 impact.
Knight reconfirmed its guidance targets for fiscal 2024. Knight expects to generate between $335 million to $350 million in revenues and adjusted EBITDA 1 to be approximately 17% of revenues. The guidance is based on a number of assumptions, including but not limited to the following:
- no revenues for business development transactions not completed as at May 8, 2024
- no unforeseen termination to our license, distribution & supply agreements
- no interruptions in supply whether due to global supply chain disruptions or general manufacturing issues
- no new generic entrants on our key pharmaceutical brands
- no unforeseen changes to government mandated pricing regulations
- successful commercial execution on product listing arrangements with HMOs, insurers, key accounts, and public payers
- successful execution and uptake of newly launched products
- no material increase in provisions for inventory or trade receivables
- foreign currency exchange rates with the exception of Argentina remaining similar to 2023
- inflation remaining within forecasted ranges
Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Refer to the risks and assumptions referred to in the Forward-Looking Statements section of this news release for further details
| 1 | Revenues excluding the impact of IAS 29 and adjusted EBITDA are a non-GAAP measure. Refer to the definitions in section "Non-GAAP measures" for additional details. |
Conference Call Notice
Knight will host a conference call and audio webcast to discuss its first quarter ended March 31, 2024, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.
Date: Thursday, May 9, 2024
Time: 8:30 a.m. ET
Telephone : Toll Free: 1-800-836-8184 or International 1-289-819-1350
Webcast: www.knighttx.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.
Replay: An archived replay will be available for 30 days at www.knighttx.com
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023 as filed on www.sedarplus.c a . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information or future events, except as required by law.
CONTACT INFORMATION:
| Investor Contact: | ||
| Knight Therapeutics Inc. | ||
| Samira Sakhia | Arvind Utchanah | |
| President & Chief Executive Officer | Chief Financial Officer | |
| T: 514.484.4483 | T. +598.2626.2344 | |
| F: 514.481.4116 | ||
| Email: IR@knighttx.com | Email: IR@knighttx.com | |
| Website: www.knighttx.com | Website: www.knighttx.com |
References:
1. Hauser RA et al. JAMA Neurol. 2023 Oct 1;80(10):1062-1069.
IMPACT OF HYPERINFLATION
[In thousands of Canadian dollars]
Hyperinflation
The Company applies IAS 29, Financial Reporting in Hyperinflation Economies, as the Company's Argentine subsidiaries used the Argentine Peso as their functional currency. IAS 29 requires that the financial statements of an entity whose functional currency is the currency of a hyperinflationary economy be adjusted based on an appropriate general price index to express the effects of inflation.
Financial results excluding the impact of hyperinflation
If the Company did not apply IAS 29, the effect on the Company's operating income would be as follows:
| Q1-24 | ||||||
| Reported under IFRS | Impact of IAS 29 1 | Adjusted 1 | ||||
| Revenues | 86,604 | (809 | ) | 85,795 | ||
| Cost of goods sold | 44,905 | 195 | 45,100 | |||
| Gross margin | 41,699 | (1,004 | ) | 40,695 | ||
| Gross margin (%) | 48 | % | 47 | % | ||
| Expenses | ||||||
| Selling and marketing | 12,649 | (156 | ) | 12,493 | ||
| General and administrative | 10,538 | (326 | ) | 10,212 | ||
| Research and development | 4,980 | (140 | ) | 4,840 | ||
| Amortization of intangible assets | 10,872 | (26 | ) | 10,846 | ||
| Operating income | 2,660 | (356 | ) | 2,304 | ||
| 1 | Financial results excluding the impact of hyperinflation is a non-GAAP measure. Refer to section "Non-GAAP measures" for additional details. |
| Q1-23 | ||||||
| Reported under IFRS | Impact of IAS 29 1 | Adjusted 1 | ||||
| Revenues | 82,597 | 70 | 82,667 | |||
| Cost of goods sold | 41,835 | (554 | ) | 41,281 | ||
| Gross margin | 40,762 | 624 | 41,386 | |||
| Gross margin (%) | 49 | % | 50 | % | ||
| Expenses | ||||||
| Selling and marketing | 10,665 | 48 | 10,713 | |||
| General and administrative | 9,106 | (219 | ) | 8,887 | ||
| Research and development | 4,187 | (85 | ) | 4,102 | ||
| Amortization of intangible assets | 11,171 | (46 | ) | 11,125 | ||
| Operating income | 5,633 | 926 | 6,559 | |||
| 1 | Financial results excluding the impact of hyperinflation is a non-GAAP measure. Refer to section "Non-GAAP measures" for additional details. |
| SELECTED FINANCIAL RESULTS AT CONSTANT CURRENCY | |||||||||
| Q1-24 | Q1-23 | Variance | |||||||
| Excluding impact of IAS 29 1 | |||||||||
| Constant Currency 1 | $ 2 | % 3 | |||||||
| Revenues | 85,795 | 86,147 | (352 | ) | — | % | |||
| Gross margin | 40,695 | 43,189 | (1,073 | ) | 2 | % | |||
| Gross margin % | 47 | % | 50 | % | |||||
| Operating expenses 4 | 38,391 | 35,256 | (3,135 | ) | 9 | % | |||
| EBITDA 1 | 13,589 | 19,688 | (6,099 | ) | 31 | % | |||
| Adjusted EBITDA 1 | 13,589 | 19,688 | (6,099 | ) | 31 | % | |||
| Adjusted EBITDA per share 1 | 0.13 | 0.18 | (0.05 | ) | 28 | % | |||
| 1 | Financial results at constant currency, excluding the impact of hyperinflation, EBITDA, adjusted EBITDA and adjusted EBITDA per share are non-GAAP measures. Refer to section "Non-GAAP measures" for additional details. |
| 2 | A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss). |
| 3 | Percentage change is presented in absolute values. |
| 4 | Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, and amortization of intangible assets. |
NON-GAAP MEASURES
[In thousands of Canadian dollars]
The Company discloses non-GAAP measures and ratios that do not have standardized meanings prescribed by IFRS. The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company's financial performance. Non-GAAP financial measures and adjusted EBITDA per share ratio do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.
The Company uses the following non-GAAP measures:
Revenues and Financial results excluding the impact of hyperinflation under IAS 29 : Revenues and financial results under IFRS are adjusted to remove the impact of hyperinflation under IAS 29. The impact of hyperinflation under IAS 29 is calculated by applying an appropriate general price index to express the effects of inflation. After applying the effects of translation, the statement of loss is converted using the closing foreign exchange rate of the month.
Revenues and Financial results at constant currency : Revenues and financial results at constant currency are obtained by translating the prior period revenues and financial results from the functional currencies to CAD using the conversion rates in effect during the current period. Furthermore, with respect to Argentina, the Company excludes the impact of hyperinflation and translates the revenues and results at the average exchange rate in effect for each of the periods.
Revenues and financial results at constant currency allow the results to be viewed without the impact of fluctuations in foreign currency exchange rates thereby facilitating the comparison of results period over period. The presentation of revenues and financial results under constant currency is considered to be a non-GAAP measure and does not have any standardized meaning under GAAP. As a result, the information presented may not be comparable to similar measures presented by other companies.
Adjusted Gross Margin: Adjusted gross margin excludes the impact of IAS 29.
EBITDA: Operating income or loss adjusted to exclude amortization and impairment of non-current assets, depreciation, purchase price allocation accounting adjustments, the impact of IAS 29 (accounting under hyperinflation) but to include costs related to leases.
Adjusted EBITDA: EBITDA adjusted for acquisition costs and non-recurring expenses.
Adjusted EBITDA per share: Adjusted EBITDA over number of common shares outstanding at the end of the respective period.
Reconciliation to EBITDA, adjusted EBITDA and adjusted EBITDA per share
For the three-month period March 31, 2024, the Company calculated EBITDA and adjusted EBITDA as follows:
| Change | |||||||||
| Q1-24 | Q1-23 | $ 1 | % 2 | ||||||
| Operating income | 2,660 | 5,633 | (2,973 | ) | 53 | % | |||
| Adjustments to operating income: | |||||||||
| Amortization of intangible assets | 10,872 | 11,171 | (299 | ) | 3 | % | |||
| Depreciation of property, plant and equipment and ROU assets | 1,709 | 1,912 | (203 | ) | 11 | % | |||
| Lease costs (IFRS 16 adjustment) | (882 | ) | (731 | ) | (151 | ) | 21 | % | |
| Impact of IAS 29 | (770 | ) | 252 | (1,022 | ) | 406 | % | ||
| EBITDA | 13,589 | 18,237 | (4,648 | ) | 25 | % | |||
| Adjusted EBITDA | 13,589 | 18,237 | (4,648 | ) | 25 | % | |||
| Adjusted EBITDA per share | 0.13 | 0.17 | (0.04 | ) | 24 | % | |||
| 1 | A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss). |
| 2 | Percentage change is presented in absolute values. |
The Company calculated adjusted EBITDA per share as follows:
| Q1-24 | Q1-23 | |
| Adjusted EBITDA | 13,589 | 18,237 |
| Adjusted EBITDA per share | 0.13 | 0.17 |
| Number of common shares outstanding at period end (in thousands) | 101,187 | 110,082 |
| INTERIM CONSOLIDATED BALANCE SHEETS [In thousands of Canadian dollars] | ||
| As at | March 31, 2024 | December 31, 2023 |
| ASSETS | ||
| Current | ||
| Cash and cash equivalents | 62,835 | 58,761 |
| Marketable securities | 111,436 | 95,657 |
| Trade receivables | 85,963 | 88,722 |
| Other receivables | 6,127 | 7,427 |
| Inventories | 95,400 | 91,834 |
| Prepaids and deposits | 5,251 | 4,881 |
| Other current financial assets | 17,983 | 15,753 |
| Income taxes receivable | 3,450 | 2,080 |
| Total current assets | 388,445 | 365,115 |
| Marketable securities | 7,588 | 7,407 |
| Prepaids and deposits | 7,811 | 7,767 |
| Right-of-use assets | 7,100 | 6,190 |
| Property, plant and equipment | 14,447 | 11,669 |
| Intangible assets | 290,734 | 289,960 |
| Goodwill | 85,505 | 79,844 |
| Other financial assets | 98,231 | 112,616 |
| Deferred tax assets | 23,854 | 19,390 |
| Other long-term receivables | 44,490 | 45,535 |
| 579,760 | 580,378 | |
| Total assets | 968,205 | 945,493 |
| INTERIM CONSOLIDATED BALANCE SHEETS (continued) [In thousands of Canadian dollars] | ||
| As at | March 31, 2024 | December 31, 2023 |
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||
| Current | ||
| Accounts payable and accrued liabilities | 86,034 | 85,366 |
| Lease liabilities | 2,782 | 1,728 |
| Other liabilities | 1,646 | 1,046 |
| Bank loans | 19,316 | 17,850 |
| Income taxes payable | 1,586 | 1,182 |
| Other balances payable | 5,121 | 6,857 |
| Total current liabilities | 116,485 | 114,029 |
| Accounts payable and accrued liabilities | 8,677 | 5,251 |
| Lease liabilities | 5,071 | 5,497 |
| Bank loans | 42,925 | 44,016 |
| Other balances payable | 28,645 | 27,012 |
| Deferred tax liabilities | 4,513 | 2,817 |
| Total liabilities | 206,316 | 198,622 |
| Shareholders' equity | ||
| Share capital | 540,134 | 540,046 |
| Warrants | 117 | 117 |
| Contributed surplus | 26,501 | 25,991 |
| Accumulated other comprehensive income | 48,795 | 29,829 |
| Retained earnings | 146,342 | 150,888 |
| Total shareholders' equity | 761,889 | 746,871 |
| Total liabilities and shareholders' equity | 968,205 | 945,493 |
| INTERIM CONSOLIDATED STATEMENTS OF LOSS [In thousands of Canadian dollars, except for share and per share amounts] | ||||
| Three months ended March 31, | ||||
| 2024 | 2023 | |||
| Revenues | 86,604 | 82,597 | ||
| Cost of goods sold | 44,905 | 41,835 | ||
| Gross margin | 41,699 | 40,762 | ||
| Gross margin % | 48 | % | 49 | % |
| Expenses | ||||
| Selling and marketing | 12,649 | 10,665 | ||
| General and administrative | 10,538 | 9,106 | ||
| Research and development | 4,980 | 4,187 | ||
| Amortization of intangible assets | 10,872 | 11,171 | ||
| Operating income | 2,660 | 5,633 | ||
| Interest income on financial instruments measured at amortized cost | (2,136 | ) | (2,179 | ) |
| Other interest income | (505 | ) | (1,173 | ) |
| Interest expense | 2,577 | 2,791 | ||
| Other (income) expense | (169 | ) | 94 | |
| Net loss on financial assets measured at fair value through profit or loss | 16,267 | 11,847 | ||
| Foreign exchange gain | (1,934 | ) | (73 | ) |
| Gain on hyperinflation | (4,296 | ) | (728 | ) |
| Loss before income taxes | (7,144 | ) | (4,946 | ) |
| Income taxes | ||||
| Current | 1,669 | 2,106 | ||
| Deferred | (4,267 | ) | (3,115 | ) |
| Income tax recovery | (2,598 | ) | (1,009 | ) |
| Net loss | (4,546 | ) | (3,937 | ) |
| Basic and diluted net loss per share | (0.04 | ) | (0.04 | ) |
| Basic and diluted weighted average number of common shares outstanding | 101,173,461 | 111,518,305 | ||
| INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS [In thousands of Canadian dollars] | ||||
| Three months ended March 31, | ||||
| 2024 | 2023 | |||
| OPERATING ACTIVITIES | ||||
| Net income (loss) for the period | (4,546 | ) | (3,937 | ) |
| Adjustments reconciling net income to operating cash flows: | ||||
| Depreciation and amortization | 12,581 | 13,083 | ||
| Net loss (gain) on financial instruments | 16,267 | 11,847 | ||
| Unrealized foreign exchange (gain) loss | (2,205 | ) | (1,253 | ) |
| Other operating activities | (6,724 | ) | (499 | ) |
| 15,373 | 19,241 | |||
| Changes in non-cash working capital and other items | 15,508 | (14,925 | ) | |
| Cash inflow from operating activities | 30,881 | 4,316 | ||
| INVESTING ACTIVITIES | ||||
| Purchase of marketable securities | (36,297 | ) | (109,216 | ) |
| Proceeds on maturity of marketable securities | 22,316 | 105,968 | ||
| Investment in funds | (131 | ) | (22 | ) |
| Purchase of intangible assets | (10,082 | ) | (7,667 | ) |
| Other investing activities | (172 | ) | 2,223 | |
| Cash inflow (outflow) from investing activities | (24,366 | ) | (8,714 | ) |
| FINANCING ACTIVITIES | ||||
| Repurchase of common shares through Normal Course Issuer Bid | — | (10,514 | ) | |
| Principal repayment of bank loans | (1,729 | ) | (587 | ) |
| Proceeds from bank loans | 545 | 647 | ||
| Other financing activities | (1,713 | ) | (1,418 | ) |
| Cash outflow from financing activities | (2,897 | ) | (11,872 | ) |
| Increase (decrease) in cash and cash equivalents during the period | 3,618 | (16,270 | ) | |
| Cash and cash equivalents, beginning of the period | 58,761 | 71,679 | ||
| Net foreign exchange difference | 456 | 809 | ||
| Cash and cash equivalents, end of the period | 62,835 | 56,218 | ||
| Cash and cash equivalents | 62,835 | 56,218 | ||
| Marketable securities | 119,024 | 104,251 | ||
| Total cash, cash equivalents and marketable securities | 181,859 | 160,469 | ||
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Knight Therapeutics Enters into Exclusive Supply and Distribution Agreement with Ironshore Pharmaceuticals & Development, Inc. for JORNAY PM® for Canada and Latin America
Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has entered into an exclusive supply and distribution agreement with Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Ironshore Therapeutics, Inc. ("Ironshore"), granting Knight the rights to seek regulatory approval and commercialize JORNAY PM ® in Canada and Latin America. Currently approved in the US, JORNAY PM ® is an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Financial terms of the agreement were not disclosed.
JORNAY PM ® is the first and only evening-dosed methylphenidate product commercially available in the United States to treat ADHD in patients 6 years of age and older. JORNAY PM ® consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient from the early morning and throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until they go to bed. JORNAY PM ® was studied in two randomized, double-blind, placebo-controlled, phase 3 clinical trials 1,2 . Both studies met their primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful improvement in ADHD symptoms upon awakening, through the afternoon, and into the evening. JORNAY PM ® was submitted for approval in Canada in November 2023.
"With this transaction, Knight is bringing a highly innovative and differentiated ADHD stimulant medication and are continuing to build a very promising pipeline in ADHD in Canada and LATAM" said Samira Sakhia, President and CEO of Knight. "We are excited to provide treatment options to patients across their treatment journey and execute our strategy of expanding our presence in CNS. "
"We are excited to partner with Knight, a company with demonstrated capabilities and a commitment to patients with ADHD. Ironshore is confident in Knight's commercial experience to successfully launch JORNAY PM ® in Canada and Latin America," said Stephanie Read, Ironshore's President and CEO. "Ironshore is proud to expand the availability of JORNAY PM ® outside the United States and provide patients with ADHD and their caregivers innovative alternatives in ADHD intervention."
About ADHD 3
ADHD is a chronic, often lifelong neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5-9% in children and adolescents, and 3-5% in adults. The disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity that can significantly impact an individual's ability to function in daily life. Although patients' symptoms of ADHD can change over time, they will generally require continued monitoring and treatment over their lifetime. Current first-line pharmacotherapies for ADHD include long-acting methylphenidate or amphetamine-based psychostimulants. Both classes of psychostimulants have comparable efficacy and tolerability at the population level, but individual products for both differ in their delivery systems and release profiles to provide distinct durations of effect. However, not all patients derive adequate symptom coverage with currently available therapies. As a result, there remains a significant medical need for additional treatment options for patients with ADHD.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statements for Knight
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
CONTACT INFORMATION FOR KNIGHT:
| Investor Contact: | ||
| Knight Therapeutics Inc. | ||
| Samira Sakhia | Arvind Utchanah | |
| President & Chief Executive Officer | Chief Financial Officer | |
| T: 514.484.4483 | T. +598.2626.2344 | |
| F: 514.481.4116 | ||
| Email: IR@knighttx.com | Email: IR@knighttx.com | |
| Website: www.knighttx.com | Website: www.knighttx.com |
References:
- Childress, A. C., Cutler, A. J., Marraffino, A., McDonnell, M. A., Turnbow, J. M., Brams, M., DeSousa, N. J., Incledon, B., Sallee, F. R., & Wigal, S. B. (2020). A randomized, double-blind, placebo-controlled study of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder: An evaluation of safety and efficacy throughout the day and across settings. Journal of Child and Adolescent Psychopharmacology, 30(1), 2–14. https://doi.org/10.1089/cap.2019.0070
- Pliszka, S. R., Wilens, T. E., Bostrom, S., Arnold, V. K., Marraffino, A., Cutler, A. J., López, F. A., DeSousa, N. J., Sallee, F. R., Incledon, B., & Newcorn, J. H. (2017). Efficacy and safety of HLD200, delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 27(6), 474–482. https://doi.org/10.1089/cap.2017.0084
- CADDRA - Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. https://adhdlearn.caddra.ca/wp-content/uploads/2022/08/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf
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Knight Therapeutics Inc. announces voting results from the Annual General Meeting
Knight Therapeutics Inc. (TSX:GUD) ("Knight" or the "Corporation") a leading pan-American (ex-US) specialty pharmaceutical company, announced today the voting results from the Annual General Meeting of the Shareholders held virtually in Montreal, Quebec ("Meeting").
Election of Directors
Each director nominee listed in the Management Information Circular dated April 3, 2024 ("Circular") was elected as Director of the Corporation at the Meeting. Shareholders present in person or represented by proxy at the Meeting voted as follows:
| DIRECTOR NOMINEE | OUTCOME | VOTES FOR | % FOR | VOTES AGAINST | % AGAINST | ||
| Jonathan Ross Goodman | Elected | 70,117,624 | 97.12% | 2,080,311 | 2.88% | ||
| James C. Gale | Elected | 71,705,717 | 99.32% | 492,219 | 0.68% | ||
| Samira Sakhia | Elected | 72,036,607 | 99.78% | 161,329 | 0.22% | ||
| Robert N. Lande | Elected | 71,861,489 | 99.53% | 336,446 | 0.47% | ||
| Michael J. Tremblay | Elected | 71,037,851 | 98.39% | 1,160,084 | 1.61% | ||
| Nicolás Sujoy | Elected | 71,977,433 | 99.69% | 220,502 | 0.31% | ||
| Janice Murray | Elected | 71,977,013 | 99.69% | 220,922 | 0.31% | ||
Appointment of external Auditors
Ernst & Young LLP were appointed as external auditors of the Corporation for the next year by a majority of the votes cast by the shareholders present or represented by proxy, and the directors were authorized to determine their remuneration. Shareholders present in person or represented by proxy at the Meeting voted as follows:
| OUTCOME | VOTES FOR | % FOR | VOTES WITHHELD | % WITHHELD | ||
| Appointed | 72,324,784 | 99.85% | 105,117 | 0.15% | ||
Renewal of unallocated rights under the Omnibus Equity Incentive Plan
The resolution to approve the renewal of unallocated rights under the Corporation's Omnibus Equity Incentive Plan, as described in the Circular, was approved by a majority of the votes cast by the shareholders present or represented by proxy. Shareholders present in person or represented by proxy at the Meeting voted as follows:
| OUTCOME | VOTES FOR | % FOR | VOTES AGAINST | % WITHHELD | ||
| Approved | 63,353,978 | 87.75% | 8,843,958 | 12.2% | ||
The results of the final votes regarding all matters subject to a vote during the Meeting will also be made available on SEDAR ( www.sedarplus.ca ).
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
| Investor Contact: | ||
| Knight Therapeutics Inc. | ||
Samira Sakhia | Arvind Utchanah | |
| President & Chief Executive Officer | Chief Financial Officer | |
| T: 514.484.4483 | T. +598.2626.2344 | |
| F: 514.481.4116 | ||
| Email: info@knighttx.com | Email: info@knighttx.com | |
| Website: www.knighttx.com | Website: www.knighttx.com |
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