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Results reflect strong growth across all leading prescription products, including IXINITY, Rupall, and Gleolan
Management to host conference call at 8:00 AM Eastern Time on Wednesday, November 9, 2022
TORONTO and CHICAGO, Nov. 08, 2022 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s second fiscal quarter ended September 30, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise.
Financial Highlights for Fiscal Q2 2023
* Refer to “Non-GAAP Measures” at the end of this press release for information about Adjusted EBITDA and Adjusted Net Income (Loss).
Ken d’Entremont, Chief Executive Officer of Medexus, commented, “This was an excellent quarter for Medexus, demonstrating both the robustness of our product portfolio and our initiatives to improve margins and drive sales. Preliminary results of our IXINITY manufacturing initiative have started to produce improved yields, which contributed to this quarter’s improvements in our gross margins. During the quarter, we delivered organic growth across all our leading prescription products, and completed the transition to full commercial responsibility for Gleolan in the U.S. We are excited to see Gleolan’s contribution over the coming quarters as we execute on our commercial plan, which includes improved sales and marketing initiatives.”
Marcel Konrad, Chief Financial Officer of Medexus, further noted, “During the second quarter we delivered an increase in our cash position versus previous quarter and generated positive operating cash flow this quarter. We also invested in our net working capital, including inventory and accounts receivable, as we prepare for continued growth and new business, especially as it relates to Gleolan. We anticipate seeing the benefit of these investments in our cash flow in the coming quarters. We are also actively evaluating strategies to optimize our balance sheet and capital structure to support this growth and have engaged third-party advisors to help us in this initiative.”
Operational highlights for the three-month period ended September 30, 2022 and subsequent period include:
Product pipeline highlights
Medexus’s financial statements and management’s discussion and analysis for the fiscal quarter ended September 30, 2022 are available on Medexus’s corporate website at www.medexus.com and in the company’s corporate filings on SEDAR at www.sedar.com.
Conference Call Details
Medexus will host a conference call at 8:00 AM Eastern Time on Wednesday, November 9, 2022, to discuss the company’s operating and financial results and corporate updates for fiscal Q2 2023.
To participate in the call, please dial the following numbers:
888-506-0062 (toll-free) for Canadian and U.S. callers
+1 973-528-0011 for international callers
Access code: 424091
A live webcast of the call will be available on the Investors—News & Events—IR Calendar section of Medexus’s corporate website or at the following link:
A replay of the call will be available approximately one hour following the end of the call through Wednesday, November 16, 2022. To access the replay, please dial the following numbers:
877-481-4010 for Canadian and U.S. callers
+1 919-882-2331 for international callers
Conference ID: 47041
A replay of the webcast will be available on the Investors—News & Events—IR Calendar section of Medexus’s corporate website until Thursday, November 9, 2023.
Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products. Our current focus is on the therapeutic areas of hematology, auto-immune diseases, and allergy. We continue to build a highly differentiated company with a growing portfolio of innovative and high-value orphan and rare disease products that will underpin our growth for the next decade.
Our current leading products are IXINITY®, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B (a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding); Rasuvo™ and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; Rupall®, an innovative prescription allergy medication with a unique mode of action; and Gleolan™ (aminolevulinic acid hydrochloride or ALA HCl), an FDA-approved, orphan drug designated optical imaging agent currently indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.
We have also licensed treosulfan, part of a preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, for commercialization in the United States and Canada. Treosulfan was approved by Health Canada in June 2021 and is marketed in Canada as Trecondyv®. Treosulfan is currently the subject of a regulatory review process with the U.S. Food and Drug Administration.
Our mission is to provide the best healthcare products to healthcare professionals and patients. We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration.
For more information, please contact any of the following:
Ken d’Entremont, Chief Executive Officer
Marcel Konrad, Chief Financial Officer
Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words “anticipates”, “believes”, “expects”, “will”, “plans”, “potential”, and similar words or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements regarding Medexus’s business strategy or outlook and future growth plans, expectations regarding future financial or operating performance (including with respect to the expected benefits of improvements made to the IXINITY manufacturing process and expected results from sales of Gleolan in the United States), ability to obtain FDA approval for treosulfan, the possibility of expanding the patient population eligible for IXINITY and the timing of a related submission to the FDA, the possibility of expanding the approved indications for Gleolan, and competitive position of and anticipated trends and challenges in the company’s business and the markets in which it operates. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in Medexus’s materials filed with the Canadian securities regulatory authorities from time to time, including Medexus’s most recent annual information form and management’s discussion and analysis; future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; Medexus’s ability to implement its business plan; Medexus’s ability to leverage its U.S. and Canadian infrastructure to promote additional growth; regulatory approval by relevant health authorities, including the FDA; product reimbursement by third party payers; litigation or expiry with respect to patents or other intellectual property rights; litigation risk; stock price volatility; government regulation; and potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which are made only as of the date hereof. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.
Trademarks and trade names
This press release contains references to trademarks and service marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and trade names referred to in this document may appear without the “®” or “™” symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders of the relevant intellectual property rights will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names.
Company management uses, and this press release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include “non-GAAP financial measures” and “non-GAAP ratios” (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus’s method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies.
In particular, management uses Adjusted Net Income (Loss) and Adjusted EBITDA as measures of Medexus’s performance. Adjusted Net Income (Loss), EBITDA (earnings before interest, taxes, depreciation, and amortization) and Adjusted EBITDA are non-GAAP financial measures. In addition, Adjusted Net Income (Loss) may be presented on a per share basis.
An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading “Preliminary Notes—Non-GAAP measures” in Medexus’s most recent management’s discussion and analysis. A reconciliation of each of these non-GAAP measures to the most directly comparable IFRS measure can be found under the heading “Reconciliation of Adjusted Net Income (Loss) and Adjusted EBITDA to Net Income (Loss)” below.
Reconciliation of Adjusted Net Income (Loss) and Adjusted EBITDA to Net Income (Loss)
The following tables are derived from and should be read together with Medexus’s consolidated statement of operations for the three- and six-month periods ended September 30, 2022. This supplementary disclosure is intended to more fully explain disclosures related to Adjusted Net Loss and Adjusted EBITDA and provides additional information related to Medexus’s operating performance. However, Medexus’s non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus’s financial information as reported under IFRS.
[ICWB: BB to update to current MD&A.]
|(Amounts in $ ’000s)||Three-month periods ended September 30||Six-month periods ended September 30|
|Net income (loss)||(2,730||)||10,145||(4,128||)||3,558|
|Unrealized gain on fair value of derivatives||(113||)||(16,280||)||(2,352||)||(19,526||)|
|Adjusted net loss||(2,843||)||(6,135||)||(6,480||)||(15,968||)|
|Three-month periods ended September 30||Six-month periods ended September 30|
|(Amounts in $ ’000s)||2022||2021||2022||2021|
|Depreciation and amortization (property, equipment, intangible assets)||1,537||1,549||3,079||3,128|
|Income tax recovery||189||(2,525||)||35||(2,525||)|
|Foreign exchange loss||1,308||597||1,983||384|
|Unrealized gain on fair value of derivatives||(113||)||(16,280||)||(2,352||)||(19,526||)|