Valeo Pharma making progress as it bids to become leading Canada-focused specialty pharma group

Strategy to acquire, license, and commercialize high-quality products Experienced management team with relationships with key industry leaders A large product portfolio What Valeo Pharma does: Founded in 2003, Valeo Pharma Inc (CSE:VPH) (OTCQB:VPHI) (FRA:VP2) aims to be a leading Canada-focused specialty pharma group, bringing drugs to clinicians and patients, and to partner with international firms who want to enter the country's market.  Initially focused on dermatology, which it exited in 2014, Valeo, headquartered in Quebec, has to date brought more than 20 products to market since inception through acquisitions and licensing. It is focused, though not exclusively, in the fields of neurodegenerative diseases, cancer and hospital specialty products. It is also helping in the fight against coronavirus (COVID-19). It boasts a large product portfolio, which includes nine marketed therapeutics, including Onstryv (Parkinson's disease), Hersperco (for the immune system), Ondansetron (to prevent nausea) and M-Eslon (for pain management). It also has six products, which it aims to launch, with filed or approved regulatory status. Valeo has also bought the Canadian rights to seven additional hospital products not yet approved in the territory from four different partners. Regulatory filings are expected to take place over the coming year, with marketing approval to follow within nine to 15 months. The firm also wants to pursue further products and opportunities in neurology, women's health, and hospital products. How is it doing: Valeo has made making significant progress so far in 2021. On April 15, the company said it had commenced commercial shipments across Canada of Redesca and Redesca HP, its low molecular weight heparin (LMWH) biosimilar. LMWHs are injectable anticoagulant drugs used primarily to treat and prevent deep vein thrombosis and pulmonary embolism. In addition to being used primarily for treating and preventing deep vein thrombosis and pulmonary embolism, LMWH are also now increasingly used as a first line of defense tool in the fight against coronavirus (COVID-19). Then, on April 28, Valeo Pharma revealed that it has entered into a Product Listing Agreement (PLA) with the executive officer of the Ontario Public Drug Program for the listing of Redesca and Redesca HP, its low molecular weight heparin (LMWH) biosimilar, on the Ontario Drug Benefit Formulary with effect from April 30, 2021. At the start of April, the company said it had completed its negotiations and entered into a letter of intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding Redesca and Redesca HP. Established in August 2010, Valeo noted that the pan-Canadian Pharmaceutical Alliance 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. And in January, Valeo Pharma said it had received notice of a positive recommendation from Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) to the Health Minister concerning its medications for the prevention and treatment of thromboembolic disorders. The company said the recommendation calls for the inclusion of Redesca and Redesc HP, on the list of medications covered by the Régie de l’assurance maladie du Québec (RAMQ). Away from Redesca and Redesc HP, at the end of March, Valeo Pharma revealed that it had struck a deal with Novartis Pharmaceuticals to commercialize two Health Canada approved asthma therapies. Under the agreement, Valeo will be responsible for medical and commercial activities for Enerzair Breezhaler and Atectura Breezhaler for an initial eight years, positioning it as one of the leading Canadian respiratory companies. And in February Valeo Pharma announced that its Hesperco capsules will be at the core of the Montreal Heart Institute's (MHI) clinical trial called 'The Hesperidin Coronavirus Study'. The company said the MHI's study will evaluate the effect of hesperidin on coronavirus (COVID-19) symptoms and its ability to reduce disease severity and the need for hospitalization in patients with COVID-19. The randomized, double-blind, placebo-controlled study will enroll 216 confirmed COVID-19 symptomatic patients. The Hesperco capsules have been approved by Health Canada for immune support and contain hesperidin.   On the results front, on February 25, the company reported a 76% increase in its 4Q revenue having added several new commercial products to its pharmaceutical portfolio, generating C$2.2 million in revenue for the quarter ended October 31, 2020, and $7.5 million over the full fiscal year - a 14% increase over last year’s levels. Its net loss narrowed to C$1.2 million compared to $1.4 million for the quarter ended October 31, 2019, thanks to improved gross margins derived from higher revenues. The launch of new products such as Ametop and Yondelis in Canada and Sodium Ethacrynate in the US helped to boost revenues and margins in 4Q, with a nominal increase to operating expenses, the company told shareholders. Valeo also started shipping online orders of its unique flavonoid formulation, Hesperco, after receiving approval from Health Canada.  All told, Valeo launched four new products during the last fiscal year, and has three more products set to hit the market in fiscal 2021. On the financing front, on April 27, Valeo Pharma announced that it had upsized and closed a $6.645 million non-brokered private placement of unsecured non-convertible debenture units. It said that the net proceeds of the offering would be used for working capital and general corporate purposes.  The company said it issued 6,645 unsecured non-convertible debentures units at a purchase price of $1,000 each for gross proceeds of $6,645,000. Each debenture unit consists of one unsecured non-convertible debenture of the company in the principal amount of $1,000 and 200 Class "A" share purchase warrants. In the boardroom in January, the firm named seasoned executive Frederic Fasano as its president and chief operating officer (COO), a newly-created role. Fasano has over 25 years' experience in managing strategic affiliates in Canada, Europe, and Latin America, and before joining Valeo, he was president and CEO of Servier Canada, a fully integrated affiliate of Servier Group - the independent, international and independent pharma group. Inflection points: Hesperco capsules available in major health care retailers across the country Three more new products to be commercialized in 2021 More product/deal/partnership newsflow What the boss says: In April's statement regarding the listing of Redesca and Redesca HP on the Ontario Drug Benefit Formulary, Frederic Fasano, president and COO of Valeo said: "With Ontario representing 37% of the Canadian market for LMWHs, the listing of Redesca on the Ontario public formulary is a key milestone for the Redesca commercialization program." "This is welcome news for millions of Canadians who rely on public insurance to access their prescription medications and for the Government of Ontario who will benefit from significant savings resulting from the listing of the first LMWH biosimilar. We anticipate additional provincial coverage will follow," he added. Contact the author at jon.hopkins@proactiveinvestors.com