TORONTO, Aug. 14, 2023 /CNW/ - MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, today announced its financial results for the three months ended June 30, 2023.

Second Quarter 2023 – Select Highlights

• Completed our first commercial delivery to the United States. The delivery was comprised of clinical trial material for a fully funded large-scale phase two clinical trial.
• On April 1^st, 2023, MediPharm closed the acquisition of VIVO Cannabis Inc. ("VIVO") in an all equity business combination.
• Revenue has doubled versus prior year with the incorporation of VIVO.
• Gross profit was positive for the third consecutive quarter. Largest Adjusted Gross Profit increase in company history and best adjusted gross profit since Q4 2019 at approximately 21%
• Successful integration of VIVO, including executing a restructuring and cost savings program that will save approximately $7M on an annualized basis as we progress towards our previously communicated synergy target of $7-$9M. ^(2)(3)(4)(5)
• Adjusted EBITDA⁽¹⁾ of negative $3.2M, and improvement of $3.2M or 50% versus Q2 2022 and remained consistent with Q1 2023 despite the incorporation of VIVO which historically had an Adjusted EBITDA⁽¹⁾ of negative $2M per quarter.
• Strong balance sheet, relative to our peers, with $14.7M of cash, less than $3M of debt and a plan to generate cash in the near term.

Continued Progress Solidifying Leadership in Cannabis-Based Pharmaceutical Industry

• Subsequent to the quarter, on July 28, 2023, the Company completed its first delivery of cannabis clinical trial material to a US research partner. The delivery of pharmaceutical cannabis product was for a National Institute of Health funded clinical trial, following receipt of an import permit from the US Drug Enforcement Agency (DEA) and Health Canada export permit.
• The Company has provided a full response to the US Food and Drug Administration (FDA) in relation to the initial foreign drug site inspection of its Barrie facility regarding a new Drug Master File (DMF) being referenced in a recent Abbreviated New Drug Application (ANDA). This is the first US FDA Audit of a purpose-built commercial cannabis facility in Canada. MediPharm continues in-depth correspondence with the FDA regarding its November 2022 on-site inspection related to Drug Master File being submitted as part of an Abbreviated New Drug Application (ANDA) submission by an international pharmaceutical partner.

Tremendous Growth in Medical Cannabis

• The Canadian Medical Cannabis revenue for Q2 2023 was $3.8M versus $0.2M in Q2 2022 and $0.6M in Q1 2023 driven by the integration of the VIVO medical channel, Canna Farms.
• Canna Farms has serviced patients since 2013 and is a top-ten medical channel in Canada. Since the transaction Canna Farms has listed MediPharm products for sale direct to patient. This synergy creates better margin where MediPharm produces these products at higher volume or were being purchased by third party manufacturing. It also assists in patient recruitment and retention as we are able to provide additional selection and more standardized medical products.
• International Medical revenue in Q2 2023 was $3.0M versus $0.9M in Q2 2022 and $1.8M in Q1 2023 representing a 249% and 66% growth respectively. The growth of International Medical was largely driven by the integration of VIVO's Australian business, Beacon Medical Australia.
• The Beacon Medical Australia flower portfolio is currently the number three flower brand by sales and continues to have year over year growth in pharmacy patient sales. The Company has prepared for our launch of Beacon Medical oil and vapes. It is anticipated these new high margin products will have the same success as their flower counterparts.
• In July 2023, the Company entered into an additional supply agreement with a top tier generic pharmaceutical company in Brazil. Under the agreement, the customer will apply to the Brazilian Health Regulatory Agency for a number of cannabis product approvals. MediPharm has received similar approvals in Brazil with other pharma customers. It is anticipated the delivery of additional products could begin in Q1 2024, and substantially increase the current Brazilian revenue. ⁽²⁾

Progress Towards Profitability

• Revenue for Q2 2023 of $9.6 million increased approximately 120% versus Q2 2022 and 64% versus Q1 2023 despite the seasonality of the Canadian Adult use and Wellness market.
• Q2 2023 gross profit was $0.8M/8.1% and was impacted by several discrete items including inventory write-downs, fair value adjustments, and severance for restructuring. Adjusting for these items gross margin was approximately 21%. This is the third consecutive quarter of positive gross profit. Gross profit continues to improve, driven by product mix, production efficiencies and cost reductions. Management continues to focus on efficiencies to drive gross profit.
• Total Opex, which includes G&A, Marketing and selling and R&D expenses was $7.5M in the quarter. Adjusting for severance and some other discrete items, normalized Opex was approximately $6.5M which includes $2.3M from the incorporation of VIVO. Retrospectively, if VIVO were included in our Q2 2022 results, Opex in Q2 2023 is down approximately 35% or $3.7M.

Solid Balance Sheet

• MediPharm ended Q2 2023 with $14.7M in cash and cash equivalents with approximately $3M of debt. This financial position is expected to give MediPharm longevity to execute on its short-term sales plans and provides the balance sheet strength to support the Company's long-term growth strategy. In addition, we expect that the Company's favourable summary judgement, now scheduled in front of the Court of Appeal for October 12, 2023, will strengthen the Company's balance sheet going forward. In addition, the Company has real estate assets held for sale with the ability to generate cash of approximately $2M to $3M in the near term. ⁽²⁾

Management Commentary

David Pidduck, CEO, MediPharm Labs commented, "We are very happy with our Q2 performance lead by the smooth VIVO integration that is ahead of all cost synergy targets. We are excited to have new employees, new business units, new products and capabilities and new investors and stakeholders."

Greg Hunter, CFO, MediPharm Labs added, "In Q2, we continued to make progress by growing our revenue base, improving gross margins, reducing expenses and reducing cash burn as we drive towards profitability. We have also demonstrated that we can quickly integrate and drive synergies through acquisitions." 

Financial Summary

Q2 2023 Financial Results Conference Call

MediPharm's executive management team will also host a conference call and audio webcast on Monday, August 14, 2023 at 8:30 a.m. eastern time to discuss the Company's financial results.

Conference Call:

Toll-free number: +1 (888) 330-2454 / International number: +1 (240) 789-2714

Conference ID: 4921762

Participants are asked to dial in approximately 15 minutes before the start of the call.

Audio Webcast:

An audio webcast will be available by visiting the following link here.

For those who are unable to participate on the live conference call or webcast, a replay will be available at https://www.medipharmlabs.com/investors approximately one day after completion of the call.

About MediPharm Labs 

Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment Licence from Health Canada, becoming the only company in North America to hold a domestic Good Manufacturing Licence for the extraction of natural cannabinoids. The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

In 2023, MediPharm acquired VIVO Cannabis Inc. which expanded MediPharm's reach to medical patients in Canada via Canna Farms medical ecommerce platform, and in Australia and Germany through Beacon Medical PTY and Beacon Medical GMBH. This acquisition also included Harvest Medical Clinics in Canada which provides medical cannabis patients with physician consultations for medical cannabis education and prescription.

Assumptions 

In developing the financial guidance set forth above, MediPharm and VIVO made the following assumptions and relied on the following factors and considerations:

• The targets are based on MediPharm and VIVO's historical results including annualized revenue from its interim financial results for the period ended September 30, 2022, as adjusted for subsequent events including completion of the Transaction with VIVO.
• Revenue sustainability and growth depend on a variety of factors, including among other things, location, competition, legal and regulatory requirements. Prices are projected forward at recently realized wholesale and direct to patient prices.
• Cost of goods sold, before taking into account the impact of value changes in biological assets (which are non-cash in nature), and, accordingly, are excluded from calculations of EBITDA, have been projected based on estimated costs of production and capacity available from a similar supply chain.
• The immediate reduction of public company professional and service fees, such as but not limited to, errors and omissions insurance, audit services, listing expenses and external legal fees.
• Implied redundancy of employee roles in the Company, mainly in corporate functions. Impacted employee severance fees are calculated on current employment agreements and Employment Standards Act (Ontario).
• No changes to existing medical cannabis legislation and regulations in Canada, Germany, Australia and Brazil.
• All VIVO and MediPharm regulatory licenses remain in good standing with domestic and international regulators, particular Good Manufacturing Practices (GMP).

Non-IFRS Measures

This press release contains references to "EBITDA", "Adjusted EBITDA" and "Adjusted Gross Profit", which are non-IFRS financial measures. Management believes that these supplementary non-IFRS financial measures provide useful additional information related to the operating results of the Company. These non-IFRS financial measures are not recognized under IFRS and, accordingly, users are cautioned that these measures should not be construed as alternatives to net income (loss) and gross profit determined in accordance with IFRS as measures of profitability or as alternatives to the Company's IFRS-based Financial Statements. The non-IFRS measures presented may not be comparable to similar measures presented by other issuers. EBITDA refers to earnings before interest, taxes, depreciation, and amortization and is used as an indicator of the Company's overall profitability. Adjusted EBITDA is a measure of the Company's overall financial performance and is used as an alternative to earnings or income in some circumstances. Adjusted EBITDA is essentially net income (loss) with interest, taxes, depreciation and amortization, non-cash adjustments and other unusual or non-recurring items added back. Adjusted EBITDA has limitations as an analytical tool as it does not include depreciation and amortization expense, fair value adjustments for biological assets, interest income and expense, finance fees, gain in revaluation of derivative liabilities, taxes, government grants including rent and wage subsidies, one-off transactions, impairment losses on inventory and on fixed assets and intangibles, write down of deposits and share-based compensation. Because of these limitations, Adjusted EBITDA should not be considered as the sole measure of the Company's performance and should not be considered in isolation from, or as a substitute for, analysis of the Company's results as reported under IFRS. Adjusted EBITDA, as used within the Company's disclosure, may not be directly comparable to Adjusted EBITDA used by other reporting issuers. Adjusted Gross Profit refers to gross profit excluding the adjustments for accelerated depreciation, write down of non-current deposits, fair value adjustments for biological assets, severance for restructuring and write down of inventory and other one-off transactions. Adjusted Gross Profit is a useful measure as it represents gross profit for management purposes based on costs to manufacture, package and ship inventory sold, exclusive of any impairments due to changes in internal or external influences. Adjusted EBITDA and Adjusted Gross Profit do not have any standardized meanings and the Company's method of calculating such non-IFRS measures may not be comparable to calculations used by other companies bearing the same description. See "Use of Non-IFRS Measures" in the Company's management's discussion and analysis for the period ended March 31, 2023 for additional information.

Cautionary Note Regarding Forward-Looking Information

This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, statements regarding: the Company's progress toward profitability; potential annualized savings to be realized as a result of the Transaction and the Company's restructuring efforts; the anticipated timing and results of integration efforts of the Company following completion of the Transaction; potential cost synergies to be realized as a result of the Transaction; results of Investigational New Drug applications submitted to the FDA by US-based research partners; and revenue growth. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm's filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.