NuGen Announces Release of Financial Results for Q2 2024 & Update on Proposed Private Placement

Toronto, Ontario–(Newsfile Corp. – August 29, 2024) – NuGen Medical Devices Inc. (TSXV: NGMD) (the “Company” or “NuGen“) a leading developer of needle-free devices for the subcutaneous administration of therapeutics, announces the release of Q2 2024 Financial Results and is pleased to provide updates on commercial progress and its proposed private placement of up to $10 million secured convertible debentures (the “Offering“).

Q2 Financial Statements Reflect Continued Commercial Ramp-Up

Financial results for the Quarter ended June 30, 2024 were in line with management expectations. Though revenues show only modest growth for the first 6 months of the year, there was significant commercial activity in Q2 with NuGen announcing receipt of purchase orders for Canada, Europe, and Yemen, representing combined revenues of $948,000. As announced, these orders are expected to ship by the end of September 2024 which would positively impact the Company’s financial results of the 3^rd quarter of 2024. In July, NuGen also announced a repeat order for the Mexican market valued at $525,000 which is scheduled for delivery during the fourth quarter of 2024. Since revenues are recognized once shipped, a total of $1.4M of revenues, with a gross margin of $957K, from these received orders are expected in the back half of the current year as these orders convert to shipped products. If shipped as expected, these sales would lead to a record year of revenue, with a significant increase of 324% from 2023, as we begin commercial rollout of InsuJet^TM globally.

These commercial developments trend in Q2 and are reported in results being comprised of cost control, manufacturing ramp-up, and renegotiated payment terms for NuGen’s long-term debt. In previous press releases, we have identified restructuring costs as significant expense items in 2023. With the restructuring now behind us, NuGen has brought costs under control with expenses decreasing by $1,728,108 or 38% in Q2 2024 in comparison to Q2 2023, and has focused efforts on commercial ramp-up. Inventory grew in Q2 to $533,714 as we built stock to deliver the orders received during the Quarter and ramp up our manufacturing process. Finally, the long-term debt structure changed to reflect the new renegotiated terms, with a reduction of the current liabilities and an increase in the long-term liabilities.

Veronique Laberge, CFO, commented: “With a vastly improved balance sheet following the debt restructuring, upcoming revenues that will be recognized in Q3 and Q4 2024 and our strategic commercialization efforts, the Company is ready to further build and expand globally with its partners.”

Continued Commercial Progress with Manufacturing Ramp-up and Launch Readiness

With the strong order flow that developed in Q2 and Q3, NuGen is pivoting operationally with a focus on the fulfilment of orders and launch readiness. Supply chain ramp-up and manufacturing scaling are a core focus for the business in Q3 and are expected to continue. Both Sol-Millenium Medical HK Limited (“Sol-M“) and Nature Health Development (Hong Kong) Co. (“Nature Health“) have expertise in design and manufacturing and can help provide support and services to enable the scale-up of NuGen’s manufacturing operations. The Company looks forward to exploring potential synergies in this respect with Sol-M and Nature Health subject to the Offering being completed.

In addition to the supply chain, NuGen continues to work with its distribution partners in Canada, Europe, and Mexico, to be fully ready for commercial launch in these regions. Activities include the preparation of reference materials for pharmacies, qualification of Unique Device Identifiers (UDIs) with pharmacy procurement and logistics groups, and development of education and early testimonial materials for the first pharmacies that receive the product.

This scale-up activity is driving a need for a cash infusion into NuGen and has prompted the company to pursue the Offering with strategic partners.

Proposed Private Placement of up to $10M Secured Convertible Debentures with Sol-M & Nature Health is proceeding

On August 15, 2024, NuGen announced revised terms of the Offering of up to $10M in Secured Convertible Debentures adjusting the conversion price from $0.075 to $0.10 per unit. If the Offering is completed as planned, and the debentures are fully converted, Sol-M and Nature Health would each hold more than 20% of the then-issued and outstanding shares of NuGen. As noted above, Sol-M and Nature Health could offer significant synergies to NuGen and will be actively supporting the scale-up of NuGen’s business.

The TSX Venture Exchange (the “TSXV“) has conditionally approved the Offering and the Company, Sol-M and Nature Health expect to close the Offering by no later than the end of September 2024.

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.

About Nature Health:

Nature Health and its affiliates are involved in the development, manufacturing, and sales of medical consumables, including wound care, surgical products, and infection prevention solutions. Products are sold and distributed globally through the company’s hospitals, pharmacies, and e-commerce platforms.

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/

Notice Regarding Forward-Looking Information:

Neither TSXV nor its Regulation Services Provider (as that term is defined in the 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 August 29, 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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