NuGen Announces Release of Financial Results for Q1 2024 & Updates on Strong Commercial Momentum in Q2

Toronto, Ontario–(Newsfile Corp. – May 30, 2024) – NuGen Medical Devices Inc. (TSXV: NGMD) (the “Company” or “NuGen“) a leading developer of needle-free devices to administer therapeutics subcutaneously, announces the release Q1 2024 Financial Results and is pleased to provide an update on the strong commercial progress made year to date.

Q1 Financials in Line with Management Expectations

Financial Results for the Q1 period were in line with management expectations. It was a period focused on fully preparing our newest distribution channel partners in some of the world’s largest markets: Sol-Millenium (“Sol-M“) in Canada, Europe, and Brazil and Science Link in Mexico. Coming off a year of restructuring in 2023, NuGen is pivoting to commercial development and management spent Q1 focused on fully activating our channel partners and preparing for the significant ramp-up of volume expected in 2024. Q1 results reflect continued progress in our smaller existing markets before fully activating promotional activity in the larger markets with Sol-M and Science Link in Q2.

Subsequent to Q1 2024, as announced on April 15, 2024, NuGen also improved its balance sheet by renegotiating its entire long-term debt. These liabilities will then be reclassified as long-term liabilities during our next quarter, improving the financial situation for the Company.

Veronique Laberge, CFO, commented: “With the restructuring completed, we are focusing our efforts on optimizing commercial sales while managing expenses. A stronger balance sheet along with our strategic commercialization efforts is the focus ahead.”

Outlook for Q2 and 2024:

With veteran med-tech markets CEO Ian Heynen joining the company in November 2023, the management team has refocused on a number of key commercial priorities to drive both short-term and medium-term growth in InsuJet^TM sales. These key priorities include continued patient awareness and demand generation, distribution partner sales expansion and execution, and an increasing focus on awareness and education in the Clinical community, with the goal of driving physician prescriptions for the InsuJet^TM. The Company has made progress across all these priorities in Q1 2024 and expects further growth in the year ahead.

In Q1, NuGen’s management focused on fully readying the Company’s distribution & promotional partners for launch in their respective markets. Key activities included full clinical and sales training for the Sol-M and Science Link teams, development of the Sol-M branded product, and kick-off of strategic clinical support initiatives in Mexico. In each of these markets, we are seeing increasing traction, with positive market reaction and an acceleration in the order funnel for the Company.

In addition to the focus on commercial execution, NuGen has also expanded the coverage area with distribution partners appointed in Thailand, Argentina, Colombia, Peru, and Costa Rica. With the significant ramping of the orders pipeline, Mr. Heynen also visited the manufacturing sites where he confirmed the strong quality system and regulatory compliance culture that will underpin growth. To that end, NuGen’s management has developed a scale-up plan that leverages our key outsourced manufacturing relationships with Gerresheimer and Freudenberg Medical, both multinationals serving the world’s largest healthcare companies.

NuGen’s CEO, Ian Heynen commented: “I joined the Company just over 6 months ago as NuGen was finishing up a restructuring effort. I came in as the first experienced medical technology CEO in NuGen’s history and I have to say that I am thrilled at the opportunity that lies ahead for us. We have a technology that patients love and clinicians immediately value once introduced. We offer savings to the health system in avoiding the costs of drug therapy non-compliance and needle-related injuries and waste. We have the commercial partners to make this a success and we are developing excellent opportunities in new and existing markets.“

About NuGen:

NuGen is a leading developer of needle-free devices to administer therapeutics subcutaneously.

The Company is marketing and selling its next-generation InsuJet™ needle-free injection system designed to improve the lives of millions of diabetics.

InsuJet™ is approved for sale in 42 countries around the world.

About Sol-Millennium^TM:

Sol-Millennium Medical Group is one of the world’s largest manufacturers of needles and syringes. It is vertically integrated with locations across the globe. Sol-Millennium’s innovative technology helps positive patient outcomes, saves on medication, and enhances both clinician and patient experience. With an international sales team dedicated to delivering knowledge and outstanding customer service, Sol-Millennium’s goal is to partner with those in healthcare, focusing on a healthier tomorrow.

For further information, please visit:

Websites: www.insujet.com, www.nugenmd.com and www.solm.com/insujet/
Instagram: @NuGenMD
Twitter: @NuGenMD
LinkedIn: https://www.linkedin.com/company/nugenmd/
and www.linkedin.com/company/sol-millennium-medical-group/

For further information, please contact:

Tony Di Benedetto
Executive Chairman
(416) 791-9399
tony@nugenmd.com

Ian Heynen
CEO
(416) 560-1019
ian@nugenmd.com

To arrange a media interview with NuGen, please contact:

Morna Gorman
(416) 553-1732
morna@nugenmd.com

Notice Regarding Forward-Looking Information:

Neither TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accept responsibility for the adequacy or accuracy of this release.

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.

These forward-looking statements are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. The forward-looking information contained herein is given as of the date hereof and the Company assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law.

Notice Regarding Future-Oriented Financial Information and Financial Outlooks

To the extent any forward-looking information in this presentation constitutes “future-oriented financial information” or “financial outlooks” within the meaning of applicable securities laws, such information is being provided to demonstrate the impact to the Company with potential market penetration and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such future-oriented financial information and financial outlooks. Future-oriented financial information and financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to the risks set out above. The Company’s actual financial position and results of operations may differ materially from management’s current expectations. Such information is presented for illustrative purposes only and may not be an indication of the Company’s actual financial position or results of operations.

The forward-looking information contained herein was prepared by the management of the Company based on information available at the time this press release was prepared. Unless otherwise stated, information in this press release is current as of May 30, 2024.

This press release may contain certain financial performance measures that are not recognized or defined under International Financial Reporting Standards (“IFRS“), which measures are “Non-GAAP Measures.” As a result, this data may not be comparable to data presented by other companies. The Company believes that any Non-GAAP Measures included in this presentation are useful indicators of performance and are specifically used by management to assess the current and future performance of the Company. Non-GAAP Measures should be considered together with other financial information prepared in accordance with IFRS to enable readers to evaluate the Company’s performance and prospects in a manner similar to the Company’s management. Accordingly, any Non-GAAP Measures are intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS.

Any third-party information contained herein has not been independently verified. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information. The Company disclaims and excludes all liability (to the extent permitted by law), for losses, claims, damages, demands, costs and expenses of whatever nature arising in any way out of or in connection with the information in this press release, its accuracy, completeness or by reason of reliance by any person on any of it.

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