Posted by AGORACOM-JC
at 8:12 AM on Tuesday, April 6th, 2021
Completed its negotiations and entered into a letter of intent (“LOI”) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding Redesca® and Redesca HP®, its low molecular weight heparin (“LMWH”) biosimilar, for the prevention and treatment of thromboembolic disorders.
MONTREAL , April 6, 2021 – Valeo Pharma Inc . (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) (” Valeo ” or the ” Company “), a Canadian specialty pharmaceutical company, today announced that it has completed its negotiations and entered into a letter of intent (“LOI”) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding Redesca® and Redesca HP®, its low molecular weight heparin (“LMWH”) biosimilar, for the prevention and treatment of thromboembolic disorders.
“The successful conclusion of negotiations with pCPA is a significant milestone delivered for the Redesca® commercialization program. We can now exchange with the provincial, territories and federal instances to ensure coverage under publicly funded drug plans in Canada “, said Steve Saviuk , Valeo’s CEO.” While most prescriptions of LMWHs are initiated in the hospital, retail pharmacies play an important role in providing continued treatment to patients when they are discharged from hospital. Coverage by publicly funded drug plans are therefor a key component in making treatment available to Canadians”.
Commenting on the pCPA LOI, Frederic Fasano , Valeo’s President and Chief Operating Officer said; “We are particularly pleased to make Redesca ® available soon for Canadian patients and also for hospitals. The team at Valeo have worked tirelessly to ensure a robust supply of Redesca ® especially in the current pandemic conditions where patients suffering from SARS-CoV-2 are undergoing severe coagulopathy with various thromboembolic complications. LMWHs, like Redesca ® are key to prevent and treat those severe COVID-19 related thrombotic events.”
Established in August 2010 , the pan-Canadian Pharmaceutical Alliance (pCPA) conducts joint provincial/territorial/federal negotiations for brand name and generic drugs in Canada to achieve greater value for publicly funded drug programs and patients through the use of the combined negotiating power of participating jurisdictions.
About Redesca®, Redesca HP®
Redesca® is a low molecular weight heparin biosimilar. LMWHs are injectable anticoagulant drugs used primarily to treat and prevent deep vein thrombosis and pulmonary embolism. Redesca® has more than 8 years of proven in-market safety internationally and more than 150 million patient days treated in Europe alone.
About Valeo Pharma
Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory Diseases, Neurodegenerative Diseases, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit www.valeopharma.com and follow us on LinkedIn and Twitter.
Posted by AGORACOM-JC
at 6:40 PM on Wednesday, March 31st, 2021
Valeo secured the Canadian rights to Enerzair® Breezhaler® and Atectura® Breezhaler®, two new innovative Asthma therapies
Q1-21 net revenues of $1.9 million , up 11 % vs Q1-20
Frederic Fasano appointed as President and Chief Operating Officer
Redesca® and Redesca HP® receive Health Canada approval, launching in Q3
Hesperco™ capsules at the core of a Montreal Heart Institute’s COVID-19 study
MONTREAL , March 31, 2021 – Valeo Pharma Inc . (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) (” Valeo ” or the ” Company “), a Canadian pharmaceutical company, today reported its financial results for the first quarter ended January 31, 2021 .
“Our first quarter has laid the foundation for a transformational year for Valeo. The commercialization agreement with Novartis Canada positions Valeo as one of the leading Canadian companies in respirology . We are excited about the opportunity to enter the growing asthma market with two innovative drugs, Enerzair® Breezhaler® and Atectura® Breezhaler®. The Canadian asthma market exceeds $700 million annually 1 and is expected to growth at 2-3% per year over the next ten years. We expect combined peak sales of these two new drugs to exceed $100 million annually.”, said Steve Saviuk , Valeo’s CEO. “With the coming launch of Redesca, our low-molecular-weight-heparin biosimilar, and the Montreal Institute of Cardiology’s ongoing Covid-19 clinical trial involving Hesperco capsules, 2021 marks a turning point in Valeo’s history”.
Commenting on the first quarter 2021 results, Luc Mainville , Senior Vice-President and Chief Financial Officer said, “Our net revenues for the quarter continued to grow and reflected the addition of several products during the latter part of our 2020 fiscal year. Our first quarter results were impacted by calendar year-end slowdown of the pharma sector as well as increase in operating expenses to support our growth initiatives. Sales & Marketing expenses increased due to the addition of Redesca’s national key account manager team. Our General & Administrative expenses also increased during the quarter as a result of the addition to the Head Office personnel and increased marketing related expenses. We expect additional investments to be made in 2021 as we prepare ourselves to support the Canadian commercialization of Enerzair® Breezhaler® and Atectura® Breezhaler® already approved by Health Canada and available for sale. We anticipate strong revenue growth in the second quarter of fiscal 2021 and accelerated growth in the coming quarters as a result of these product additions which will derive incremental margins and drive our profitability going forward.
References:
IQVIA CDH June 2020
First Quarter 2021 Financial Results and Highlights
Net revenues were $1.9 million for the quarter ended January 31, 2021 compared to $1.7 million for the quarter ended January 31, 2020 . The increase over the previous comparable period is mainly due to the Onstryv revenue growth and the launch of new products such as Ametop, Yondelis and the launch of Sodium Ethacrynate in the U.S. ;
Net loss of $1.7 million for the quarter ended January 31, 2021 compared to $1.1 million for the quarter ended January 31, 2020 . The increase in net loss is a result of the increase in Sales & Marketing and General & Administrative expenses required to position Valeo for solid revenue growth in 2021; and
Adjusted EBITDA loss of $1.1 million for the quarter ended January 31, 2021 compared to $0.9 million for the quarter ended January 31, 2020 .
First Quarter 2021 Business and Product Highlights
In January 2021 , the Company received notice of a positive recommendation by Quebec’s Institut national d’excellence en santé et en services sociaux (“INESSS”) to the Health Minister for the inclusion of Redesca® and Redesca® HP, on the list of medications covered by the Régie de l’assurance maladie du Québec (RAMQ);
In January 2021 , the Company appointed Mr. Frederic Fasano to the newly created position of President and Chief Operating Officer. Mr. Fasano is a seasoned Canadian and international pharma executive having lead pharmaceutical organizations in Europe and Canada. His addition augments Valeo’s senior leadership team and support expansion of Valeo’s commercial activities;
In December 2020 , the Company announced that its shares were eligible for electronic clearing and settlement in the U.S. through the Depository Trust Company (“DTC”);
In December 2020 , the Company received a Notice of Compliance from Health Canada for its Redesca and Redesca HP low molecular weight heparin (“LMWH”) biosimilars; and
In November 2020 , the Company received a Notice of Compliance from Health Canada granting market authorization for Amikacin and commenced shipments of Ethacrynate Sodium in the U.S. market.
Subsequent Events
In March 2021 , the Company entered into a Commercial and Supply Agreement with Novartis Pharmaceuticals Canada Inc. for the Canadian commercialization by Valeo of two innovative asthma therapies, Enerzair ® Breezhaler ® (indacaterol (as acetate), glycopyrronium (as bromide) and mometasone furoate) and Atectura ® Breezhaler ® (indacaterol (as acetate) and mometasone furoate); and
In February 2021 , the Company announced that Hesperco™ capsules, approved by Health Canada for immune support, will be at the core of the Montreal Heart Institute’s (“MHI”) clinical trial, “The Hesperidin Coronavirus Study”;
Q1 2021 Webcast and Conference Call
Valeo will host a conference call to discuss the first quarter 2021 results and highlights on Thursday April 1, 2021 at 8.30am (EST) . The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450. An audio replay of the call will be available. The numbers to access the audio replay are 1-855-859-2056 and 416-849-0833 using the following access code (5555964).
A live audio webcast of the conference call will be available via:
Valeo Pharma’s financial statements and Management’s Discussion and Analysis for the three-month ended January 31, 2021 are available on SEDAR at www.sedar.com
About Valeo Pharma
Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory Diseases, Neurodegenerative Diseases, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit www.valeopharma.com and follow us on LinkedIn and Twitter.
Forward Looking Statements
This press release contains forward-looking statements about Valeo’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Under the Agreement, Valeo will be responsible for medical and commercial activities for an initial 8 year period.
How Significant Is This Market?
At present, almost 4 million Canadians are living with asthma a serious health issue affecting all age groups. Patients with severe asthma live in fear of potential exacerbations which remain highly prevalent even with today’s most advanced therapies. The Canadian market for asthma medication exceeds $700M annually.
What Does The CEO of Valeo say about the deal?
“We are extremely pleased to be partnering with Novartis to launch these two asthma drugs in the coming weeks. Commercializing Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® will immediately position Valeo as one of the leading Canadian respiratory companies providing first in-class and best in-class asthma therapies. The Canadian asthma maintenance market exceeds $700M annually,” said Steve Saviuk , CEO of Valeo. “This partnership is perfectly aligned with Valeo’s vision and mission of building a Canadian anchor pharmaceutical company by driving therapeutic innovation to patients in need. We look forward to building a long and mutually beneficial relationship with Novartis that will help both companies fulfill their respective missions.”
Sit Back, relax and watch this powerful interview with Steve Saviuk , CEO of Valeo.
Posted by AGORACOM-JC
at 10:47 AM on Monday, March 29th, 2021
Valeo to commercialize Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® , 2 innovative asthma therapies approved by Health Canada
Positions Valeo as one of the leading Canadian Respiratory companies
Almost 4 million Canadians afflicted with asthma 1 ; Canadian market for asthma medication exceeds $700M annually 2
MONTREAL , March 29, 2021 – Valeo Pharma Inc . (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) (” Valeo ” or the ” Company “), a Canadian pharmaceutical company, announced today that it has entered into a Commercialization and Supply Agreement (the ” Agreement “) with Novartis Pharmaceuticals Canada Inc. (” Novartis “) for the Canadian commercialization by Valeo of two asthma therapies, Enerzair ® Breezhaler ® (indacaterol (as acetate), glycopyrronium (as bromide) and mometasone furoate) 3 and Atectura ® Breezhaler ® (indacaterol (as acetate) and mometasone furoate) 4 .
Under the Agreement, Valeo will be responsible for medical and commercial activities for Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® for an initial 8 year period.
At present, almost 4 million Canadians are living with asthma 1 , a serious health issue affecting all age groups. Patients with severe asthma live in fear of potential exacerbations which remain highly prevalent even with today’s most advanced therapies . Asthma related exacerbations are concerning because of their associated mortality burden and also because of the increased risk of side effects from the use of systemic corticosteroids. Furthermore, there is growing evidence highlighting the lack of symptom control currently achieved in asthma. 39% 5 of patients remain uncontrolled, despite available dual LABA/ICS medications, primarily due to low adherence, treatment misuse and poor inhaler technique. There is an urgent need to add effective maintenance treatment options to more efficiently address symptoms as well as asthma related long-term complications and mortality.
“We are extremely pleased to be partnering with Novartis to launch these two asthma drugs in the coming weeks. Commercializing Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® will immediately position Valeo as one of the leading Canadian respiratory companies providing first in-class and best in-class asthma therapies. The Canadian asthma maintenance market exceeds $700M annually,” said Steve Saviuk , CEO of Valeo. “This partnership is perfectly aligned with Valeo’s vision and mission of building a Canadian anchor pharmaceutical company by driving therapeutic innovation to patients in need. We look forward to building a long and mutually beneficial relationship with Novartis that will help both companies fulfill their respective missions.”
“This agreement with Valeo Pharma fits with our overall strategy to provide innovative medicines that have the potential to improve health outcomes,” said Andrea Marazzi , Head, Country Pharma Organization, Novartis Pharmaceuticals Canada Inc. “Valeo’s commitment and focus to bring Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® to Canadians, combined with our strong respiratory experience, brings a solution that will help make asthma control a more attainable goal for some Canadians.”
Commenting on this commercial agreement with Novartis, Frederic Fasano , Valeo’s recently appointed President and COO said, “Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® are both benefitting from an extensive phase III clinical trial program including more than 7,500 asthma patients. The efficacy of both treatments on symptoms, lung function and rate of exacerbations have been demonstrated and this will provide Canadian patients with a significant improvement over current standards of care.” He added, “This significant addition to our expanding product portfolio is key to achieving our growth objectives. It will provide the basis for the upscaling of our organization and set the stage for future international expansion.”
The Enerzair ® Breezhaler ® and Atectura ® Breezhaler ® will both be available in the hydrofluoroalkane/chlorofluorocarbon (HFA/CFC)-free Breezhaler ® device.
Atectura, Enerzair and Breezhaler are registered trademarks.
Posted by AGORACOM-JC
at 2:41 PM on Friday, March 26th, 2021
Financial results and highlights for the first quarter ended January 31, 2021 on Wednesday March 31, 2021 after market close.
Valeo will host a conference call to discuss those results and highlights on Thursday April 1, 2021 at 8.30am (ET) .
MONTREAL , March 26, 2021 – Valeo Pharma Inc . (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) (” Valeo ” or the ” Company “), a Canadian pharmaceutical company, announced today that it will report its financial results and highlights for the first quarter ended January 31, 2021 on Wednesday March 31, 2021 after market close.
Valeo will host a conference call to discuss those results and highlights on Thursday April 1, 2021 at 8.30am (ET) . The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450. An audio replay of the call will be available. The numbers to access the audio replay are 1-855-859-2056 and 416-849-0833 using the following access code (5555964).
Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Neurodegenerative Diseases, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit www.valeopharma.com and follow us on LinkedIn and Twitter .
Posted by AGORACOM-JC
at 5:52 PM on Wednesday, February 24th, 2021
Q4-20 net revenues of $2.2 million , up 76 % vs Q4-19, 2020 net revenues of $7.5 million up 14% vs 2019
Hiring of Frederic Fasano as new President and COO
Successfully launched 4 new products during FY-20
Redesca ® , Redesca HP ® and Amikacin approved by Health Canada subsequent to year-end
$10.8 million raised in 2020 from bought deal offering and over-subscribed private placements
Valeo’s shares now trading on the US-OTCQB exchange under “VPHIF”
MONTREAL , Feb. 24, 2021 – Valeo Pharma Inc . (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) (” Valeo ” or the ” Company “), a Canadian specialty pharmaceutical company, today reported its financial results for the fourth quarter and year-ended October 31, 2020 .
“Valeo accomplished key objectives in 2020 which sets the stage for strong growth in 2021. In addition to Hesperco TM , we launched three strategic products and secured regulatory approvals for Redesca ® ,Redesca HP ® and Amikacin, all of which will be launched in the first half of 2021. We expect that these products will contribute significant revenues and margins in 2021”, said Steve Saviuk , Valeo’s CEO. “Our vision of building an anchor Canadian pharmaceutical company through therapeutic innovation is solidifying as we continue to build our commercial portfolio in therapeutic areas of focus.”
Commenting on the fourth quarter and 2020 results, Luc Mainville , Senior Vice-President and Chief Financial Officer said, “As evidenced by our revenues increase and net loss decrease of the fourth quarter, our efforts towards becoming a profitable EBITDA company are starting to bear fruit. During the last portion of 2020, the launch of new products such as Ametop ® and Yondelis® in Canada and Sodium Ethacrynate in the U.S., has contributed new revenues and margins with nominal increase to our operating expenses. The execution of our growth strategy is positioning the Company for a very successful year in 2021”.
Posted by AGORACOM-JC
at 8:19 AM on Friday, February 19th, 2021
Valeo will host a conference call to discuss those results and highlights on Thursday February 25, 2021 at 8.30am (EST) .
The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450.
MONTREAL , Feb. 19, 2021 – Valeo Pharma Inc . (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) (” Valeo ” or the ” Company “), a Canadian specialty pharmaceutical company, announced today that it will report its financial results and highlights for the fourth quarter and year ended October 31, 2020 on Wednesday February 24, 2021 after market close.
Valeo will host a conference call to discuss those results and highlights on Thursday February 25, 2021 at 8.30am (EST) . The telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450. An audio replay of the call will be available. The numbers to access the audio replay are 1-855-859-2056 and 416-849-0833 using the following access code (1498873).
