Q2 2024 KORU Medical Systems Inc Earnings Call

Speaker Change: Greetings and welcome to the Quality Medical Systems Second Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation.

Unknown Attendee: at 24 Earning School. At this time, all participants are in a listen-only mode.

Unknown Attendee: A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, do stress star and then zero on your telephone keypad. As a reminder, this conference is being recorded.

Speaker Change: If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad.

Louisa Smith: It is not my pleasure to introduce your host, Louisa Smith.

Speaker Change: As a reminder, this conference is being recorded.

Unknown Attendee: Thank you. You may begin.

Speaker Change: It is now my pleasure to introduce your host, Louisa Smith. Thank you. You may begin.

Linda Tharby: Good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of Coru Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, Coru Medical Systems released financial results for the second quarter and did June 30, 2024. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter. Additionally, we will use slides to support commentary in today's call, which are also available on the Investor Relations section of our website.

Speaker Change: Good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of Coru Medical Systems, and Tom Adams, Chief Financial Officer.

Speaker Change: Earlier today, Corrie Medical Systems released financial results for the second quarter and to June 30, 2024. A copy of the press release is available on the company's website.

Operator: I encourage listeners to have our press release in front of them, which includes our financial results as well as commentary on the quarter. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. However, actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the Associated Press release and our most recent filings with the SEC.

Louisa Smith: I encourage listeners to have our press release in front of them, which includes our financial results as well as commentary on the quarter. Additionally, we will use slides to support commentary in today's call, which is also available on the Investor Relations section of our website. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today.

Speaker Change: I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter.

Speaker Change: Additionally, we will use slides to support commentary in today's call, which are also available on the Investor Relations section of our website.

Unknown Attendee: During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the Associated Press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements.

Operator: For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 7, 2024, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed.

Speaker Change: During this call, we will make certain forward-looking statements regarding our business plans and other matters.

Louisa Smith: Actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the Associated Press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation, and SEC

Speaker Change: These comments are based on our predictions and expectations as of today.

Speaker Change: Actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements.

Unknown Attendee: During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation, and SEC filings.

Speaker Change: During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures, in our press release, the accompanying investor presentation, and SEC filings.

Unknown Attendee: For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 7, 2024, at approximately 4:30 p.m. Eastern time. Since then, the company may have made additional comments related to the topics discussed.

Louisa Smith: For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 7, 2024, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. Linda, please go ahead.

Speaker Change: For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 7, 2024, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed.

Linda Tharby: Linda, please go ahead.

Linda Tharby: Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. I will begin with our second quarter results and key business updates, followed by Tom, who will review our financials and 2024 guidance before turning it back to me for closing comments. Following these prepared remarks, we will open the line for questions. In quarter two, we continued our strong momentum and delivered another quarter of record revenues as we executed on our 2024 milestones and progressed towards Vision 2026.

Linda Tharby: Thank you, Luisa.

Linda Tharby: Good afternoon, everyone, and thank you for joining us today. I will begin with our second-quarter results and key business updates, followed by Tom, who will review our financials and 2024 guidance, before turning back to me for closing comments.

Linda Tharby: Linda, please go ahead.

Linda Tharby: Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today.

Linda Tharby: Second quarter revenues were $8.4 million, a 22% growth over the same period in 2023. Core business revenues grew 20%, driven by SCIG market growth, share gains, and geographic expansion. Our Novel Therapies business, which serves as a business development pipeline for new drugs on our Freedom platform, also had a strong quarter as we progressed several of our collaborations closer to commercialization. This included successful feasibility results for an oncology-biologic collaboration that we announced in Q1, and the entry into a phase 3 trial for an expanded nephrology indication for an existing drug.

Speaker Change: I will begin with our second quarter results and key business updates, followed by Tom, who will review our financials and 2024 guidance, before turning it back to me for closing comments. Following the prepared remarks, we will open the line for questions.

Linda Tharby: Following the prepared remarks, we will open the line for questions. In quarter two, we continued our strong momentum and delivered another quarter of record revenues as we executed on our 2024 milestones and progressed towards Vision 2026. Second-quarter revenues were 8.4 million, a 22 percent growth over the same period in 2023. Core business revenues grew 20 percent driven by SEIG market growth, share gains, and geographic expansion. Our novel therapies business, which serves as a business development pipeline for new drugs on our Freedom Platform, also had a strong quarter, as we progress several of our collaborations closer to commercialization.

Linda Tharby: In quarter two, we continued our strong momentum and delivered another quarter of record revenues as we executed on our 2024 milestones and progressed towards Vision 2026. Our Novel Therapies business, which serves as a business development pipeline for new drugs on our Freedom platform, also had a strong quarter as we progressed several of our collaborations closer to commercialization and entered into a phase three trial for an expanded nephrology indication for an existing drug. Before moving on to additional highlights, I'd also like to provide an update on the recent announcement about how we are refining our corporate organizational structure.

Linda Tharby: Additionally, in June, we received the long-awaited regulatory clearance for our Freedom Edge infusion system for use in Japan, an important milestone in our international core business that will further expand our global reach and growth. From an operations standpoint, we continued our focused efforts on cash flow breakeven with progress on multiple fronts. Higher revenues combined with gross margins above 60% and further improvement in our operating efficiencies and working capital led to an overall reduction in net loss and brought us closer to our projected fourth quarter cash flow breakeven.

Speaker Change: In Quarter 2, we continued our strong momentum and delivered another quarter of record revenues as we executed on our 2024 milestones and progressed towards Vision 2026.

Tom Adams: Second quarter revenues were $8.4 million, a 22% growth over the same period in 2023.

Tom Adams: Core business revenues grew 20% driven by SCIG market growth, share gains, and geographic expansion.

Tom Adams: Our Novel Therapies business, which serves as a business development pipeline for new drugs on our Freedom platform, also had a strong quarter as we've progressed several of our collaborations closer to commercialization.

Linda Tharby: This included successful feasibility results for an oncology biologic collaboration that we announced in Q1, and the entry into a Phase III trial for an expanded nephrology indication from existing drugs. Drug. Additionally, in June, we received the long-awaited regulatory clearance for our free-to-mage infusion system for use in Japan, an important milestone in our international core business that will further expand our global reach and growth. From an operations standpoint, we continued our focus efforts on cash flow break even, with progress on multiple fronts. Higher revenues combined with gross margins above 60 percent and further improvement in our operating efficiencies and working capital led to an overall reduction in light loss and brought us closer to our projected fourth quarter cash flow break even.

Tom Adams: This included successful feasibility results for an oncology-biologic collaboration that we announced in Q1, and the entry into a Phase III trial for an expanded nephrology indication for an existing drug.

Tom Adams: Additionally, in June , we received the long-awaited regulatory clearance for our Freedom Edge infusion system for use in Japan.

Tom Adams: an important milestone in our international core business that will further expand our global reach and growth.

Tom Adams: From an operations standpoint, we continued our focused efforts on cash flow breakeven with progress on multiple fronts.

Tom Adams: Higher revenues combined with gross margins above 60% and further improvement in our operating efficiencies and working capital led to an overall reduction in net loss and brought us closer to our projected fourth quarter cash flow break-even.

Linda Tharby: Progress against all of these milestones gives us confidence to raise our 2024 full-year revenue and gross margin guidance ranges and reaffirm our cash guidance. Before moving on to additional highlights, I'd also like to provide an update on the recent announcement about how we are refining our corporate organization structure. This past month, we announced the promotion of Chris Pasden, our SVP of Operations, to the role of Chief Operating Officer. This new role brings together all of our key functions under one leader, providing the focus and alignment needed to drive delivery on our pivotal product and program growth and operational targets. In his three years with KORU, Chris has proven himself as a transformative business leader, has consistently delivered results, and I am confident he will continue to have a tremendous impact on our success.

Linda Tharby: Progress against all of these milestones gives us confidence to raise our 2024 full-year revenue and gross margin guidance ranges and reaffirm our cash guidance.

Tom Adams: Progress against all of these milestones gives us confidence to raise our 2024 full year revenue and gross margin guidance ranges and reaffirm our cash guidance.

Linda Tharby: Before moving on to additional highlights, I'd also like to provide an update on the recent announcement about how we're refining our corporate organization structure. This past month, we announced a promotion of Chris Pastin, our SVP of Operations, to the role of Chief Operating Officer. This new role brings together all of our key functions under one leader, providing the focus and alignment needed to drive delivery on our pivotal product and program, growth and operational targets. In his three years with Coru, Chris has proven himself as a transformative business leader and has consistently delivered results. And I am confident he will continue to have tremendous impact on our success.

Tom Adams: Before moving on to additional highlights, I'd also like to provide an update on the recent announcement about how we're refining our corporate organization structure.

Tom Adams: This past month, we announced the promotion of Chris Pasden, our SVP of Operations, to the role of Chief Operating Officer.

Tom Adams: This new role brings together all of our key functions under one leader, providing the focus and alignment needed to drive delivery on our pivotal product and program growth and operational targets.

Speaker Change: In his three years with Koru, Chris has proven himself as a transformative business leader, has consistently delivered results, and I am confident he will continue to have tremendous impact on our success.

Linda Tharby: Moving on to our key business results, I'll review highlights from each of our strategic growth pillars: protecting and growing our core domestic, FCIG business; expanding internationally; and broadening our relevance with the addition of new drugs on our label, our novel therapy business. Within domestic core, we saw a strong double-jitter revenue growth of 14 percent over the prior year and continued to help pace a healthy FCIG market that's growing mid to high single digits. We accomplished this through increased penetration and new and existing accounts with both pump and consumables. We also saw a double-digit end user sales growth, an indication of strong customer demand for our products.

Linda Tharby: Moving on to our key business results, I'll review highlights from each of our strategic growth pillars, protecting and growing our core domestic SCIG Business, Expanding Internationally, and Broadening our Relevance with the Addition of New Drugs on our Label, our Novel Therapies Business. Within Domestic Core, we saw strong double-digit revenue growth of 14% over the prior year and continue to outpace a healthy SCIG market that's growing mid to high single-digit. We accomplish this through increased penetration in new and existing accounts with both pumps and consumables.

Speaker Change: Moving on to our key business results. I'll review highlights from each of our strategic growth pillars. Protecting and growing our core domestic SCIG business, expanding internationally, and broadening our relevance with the addition of new drugs on our label, our novel therapies business.

Speaker Change: Within domestic core, we saw a strong double-digit revenue growth of 14% over the prior year and continue to outpace a healthy SCIG market that's growing mid to high single digits.

Speaker Change: We accomplish this through increased penetration in new and existing accounts with both pumps and consumables.

Linda Tharby: We also saw double-digit end-user sales growth, an indication of strong customer demand for our product. The underlying IG market also recorded six-quarter sequential growth, indicating an increase in new patient starts. We continue to see our pharma partners drive pre-filled syringe adoption, a more convenient option for patients, and the fastest growing segment within SCIG. We expect to continue our momentum with the new product 510K submission in Q4 aimed at improving comfort and convenience for our patient base. Moving to international, we had a very strong quarter, finishing at 46% year-over-year growth. Excluding distributor stocking, which Tom will elaborate further on during his remarks, we saw growth of plus 20%.

Speaker Change: We also saw a double-digit end-user sales growth, an indication of strong customer demand for our products.

Linda Tharby: The underlying IG market recorded a six-quarter sequential growth, indicating an increase in new patient starts. We continued to see our farmer partners drive pre-filts for adoption, a more convenient option for patients and a fast-discrawing segment within FCIG. We expect to continue our momentum with a new product 510(k) submission in Q4 aimed at improving comfort and convenience for our patient pace. Moving to international, we had a very strong quarter, finishing at 46 percent year-over-year growth, excluding distributor stocking, which Tom will elaborate further on during his remarks. We saw growth in the plus 20 percent range. Strong performance was driven by underlying IG market growth, increased penetration in current markets, and new indications and expansion into new markets.

Speaker Change: The underlying IG market recorded a six-quarter of sequential growth, indicating an increase in new patient starts.

Speaker Change: We continue to see our pharma partners drive pre-filled syringe adoption, a more convenient option for patients, and the fastest-growing segment within SCIG.

Linda Tharby: We expect to continue our momentum with a new product 510K submission in Q4 aimed at improving comfort and convenience for our patient base. As previously mentioned, we also received regulatory clearance for Pre-Imagine Japan that will provide further upside in 2025 and beyond as we see continued subcutaneous market development. This quarter, we successfully passed feasibility for a prior announced commercialized oncology biologic. This will enable our first entry into infusion clinics, a prime new market for core root growth.

Speaker Change: We expect to continue our momentum with the new product 510K submission in Q4 aimed at improving comfort and convenience for our patient base.

Speaker Change: Moving to International, we had a very strong quarter, finishing at 46% year-over-year growth.

Speaker Change: Excluding distributor stocking, which Tom will elaborate further on during his remarks, we saw growth in the plus 20% range.

Linda Tharby: Strong performance was driven by underlying IG market growth, increased penetration in current markets and new indications, and expansion into new markets. As previously mentioned, we also received regulatory clearance for pre-imagined Japan that will provide further upside in 2025 and beyond as we see continued subcutaneous market development. In our novel therapy business development efforts, we are focused on growing the number of drugs in our freedom infusion platform. We currently have 16 pipeline collaborations to date, including three signed this year.

Tom Adams: Strong performance was driven by underlying IG market growth, increased penetration in current markets and new indications, and expansion into new markets.

Linda Tharby: As prior mentioned, we also received regulatory clearance for pre-imagined Japan that will provide further upside in 2025 and beyond as we see continued subcutaneous market development. Development. In our novel therapy business development efforts, we are focused on growing the number of drugs in our freedom and infusion platforms. We currently have 16 pipeline collaborations to date, including three signed this year. This quarter, we successfully pass feasibility for a prior announced commercialized oncology biologic. This is exciting as we anticipate that we will file a 510(k) for this product in 2025. In addition, we progress to phase three trials for a new nephrology indication for a currently marketed drug, and we have a rare disease biologic, which is in development phase, and remains on track for a 510(k) submission by the end of the year.

Tom Adams: As prior mentioned, we also received regulatory clearance for Pre-Imagine Japan that will provide further upside in 2025 and beyond as we see continued subcutaneous market development.

Speaker Change: In our novel therapy business development efforts, we are focused on growing the number of drugs on our Freedom Infusion platform.

Tom Adams: We currently have 16 pipeline collaborations to date, including three signed this year. This quarter, we successfully passed feasibility for a prior announced commercialized oncology biologic.

Linda Tharby: This quarter, we successfully passed feasibility for a prior announced commercialized oncology biologic. This is exciting as we anticipate that we will file a 510K for this product in 2025. In addition, we progressed to phase three trials for a new nephrology indication for a currently marketed drug. And we have a rare disease biologic that is in the development phase and remains on track for a 510K submission by the end of the year. This will enable our first entry into infusion clinics, a prime new market for core root growth.

Tom Adams: This is exciting as we anticipate that we will file a 510-K for this product in 2025.

Tom Adams: In addition, we progressed to phase 3 trials for a new nephrology indication for a currently marketed drug and we have a rare disease biologic which is in development phase and remains on track for a 510K submission by the end of the year.

Linda Tharby: This will enable our first entry into impusion clinics, a prime new market for quarter growth.

Tom Adams: This will enable our first entry into infusion clinics, a prime new market for coru growth.

Linda Tharby: And finally, we also announced during the quarter an agreement with Shot Parma, the world leader in large volume pre-filled syringes, to optimize and grow the market for large volume drug delivery.

Linda Tharby: And finally, we also announced during the quarter an agreement with Shot Pharma, the world leader in large-volume pre-filled syringes, to optimize and grow the market for large-volume drug delivery. A few notes to highlight: overall SCIG growth is projected in the mid to high single digits and is expected to increase in penetration with SCIG growth outpacing the overall IG mark.

Linda Tharby: And finally, we also announced during the quarter an agreement with Shot Parma, the world leader in large volume pre-filled syringes, to optimize and grow the market for large volume drug delivery. I want to take a few moments to dive deeper into the U.S. SCIG market, our largest market where we hold a leadership position, and discuss what we see as continued future growth drivers. The graph illustrates the overall patient growth in IG combining both IV and sub-Q as well as the growth in SCIG. A few notes to highlight.

Tom Adams: And finally, we also announced during the quarter an agreement with Shot Pharma, the world leader in large-volume pre-filled syringes, to optimize and grow the market for large-volume drug delivery.

Linda Tharby: I want to take a few moments to dive deeper into the USSCIG market, our largest market where we hold a leadership position and discuss what we see as continued future growth drivers. The graph illustrates the overall patient growth in IG, combining both IV and sub-Q, as well as the growth in SCIG. A few notes to highlight. Overall, SCIG growth is projected in the mid to high single digits and is expected to increase in penetration, with SCIG growth outpacing the overall IG market growth. We have a recurring patient base of just over 30,000 patients in the US.

Linda Tharby: Overall, SCIG growth is projected in the mid-to-high single digits and is expected to increase in penetration with SCIG growth outpacing the overall IG mark. We have a recurring patient base of just over 30,000 patients in the U.S. Most of these patients have a chronic disease and will be on our pump for their lifetime, creating a large recurring revenue stream through the sale of consumables. In addition, there are multiple near-term catalysts that have the ability to expand our U.S. patient base.

Speaker Change: I want us to take a few moments to dive deeper into the USS CIG market, our largest market where we hold a leadership position and discuss what we see as continued future growth drivers.

Speaker Change: The graph illustrates the overall patient growth in IG combining both IV and sub-Q as well as the growth in SCIG.

Speaker Change: A few notes to highlight. Overall SCIG growth is projected in the mid to high single digits and is expected to increase in penetration with SCIG growth outpacing the overall IG mark growth.

Linda Tharby: We have a recurring patient base of just over 30,000 patients in the U.S. The IG Pharmaceutical Companies are making investments in their subcutaneous portfolios. The significance of this is that, to date, the FDA has required the start of IV therapy prior to the start of subcutaneous therapy. This approval means the healthcare provider can put the patient directly on SCIG. We're currently marketed in 25 countries worldwide, but as you see in the graphic, our overall penetration into these markets has been relatively low.

Speaker Change: We have a recurring patient base of just over 30,000 patients in the U.S.

Linda Tharby: Most of these patients have a chronic disease and will be on our pump for their lifetime, creating a large recurring revenue base through the sale of consumables. In addition, there are multiple near-term catalysts that have the ability to expand our US patient base. One of the primary opportunities we see is the market-wide shift towards SCIG as a preferred therapy. The IG pharmaceutical companies are making investments in their subcutaneous portfolios. A recent highlight from the quarter with the FDA approval of an expanded label for an SCIG drug, to include treatment-naive patients with primary immunodeficiency. The significance of this is that today the FDA had required the start of IV therapy prior to the start of subcutaneous therapy.

Speaker Change: Most of these patients have a chronic disease and will be on our pump for their lifetime, creating a large recurring revenue race through the sale of consumables.

Speaker Change: In addition, there are multiple near-term catalysts that have the ability to expand our U.S. patient base.

Linda Tharby: One of the primary opportunities we see is a market-wide shift towards SCIG as a preferred therapy. IG Pharmaceutical Companies are making investments in their subcutaneous portfolios. A recent highlight from the quarter was the FDA approval of an expanded label for an FCIG drug, Zembify, to include treatment-naive patients with primary immunodeficiency. The significance of this is that, to date, the FDA had required the start of IV therapy prior to the start of subcutaneous therapy.

Speaker Change: One of the primary opportunities we see is a market-wide shift towards SCIG as a preferred therapy. The IG pharmaceutical companies are making investments in their subcutaneous portfolios.

Speaker Change: A recent highlight from the quarter was the FDA approval of an expanded label for an SCIG drug, Zimbify, to include treatment-naive patients with primary immunodeficiency.

Speaker Change: The significance of this is that to date the FDA had required the start of IV therapy prior to the start of subcutaneous therapy. This approval means the healthcare provider can put the patient directly on SCIG.

Linda Tharby: This approval means the healthcare provider can put the patient directly on SCIG. In addition, the CIDP market, which counts for about 10% of our overall patient base, continues to grow with new diagnosis and a new delivery option, PFS, which makes it more convenient for this high-volume, dexterity-challenge patient to move to SCIG therapy. Quora's emphasis on our key accounts and partnerships focus on leadership and clinical practice and innovation in SCIG devices will continue to ensure we remain a preferred partner for customers and patients.

Linda Tharby: This approval means the healthcare provider can put the patient directly on SCIG. In addition, the CIDP market, which accounts for about 10% of our overall patient base, continues to grow with new diagnosis and a new delivery option, PFS, which makes it more convenient for this high-volume, dexterity-challenged patient to move to FCIG therapy. CORA's emphasis on our key accounts and partnerships, focus on leadership and clinical practice, and innovation in SCIG devices will continue to ensure that we remain a preferred partner for customers and patients.

Speaker Change: In addition, the CIDP market, which counts for about 10% of our overall patient base, continues to grow with new diagnosis and a new delivery option, PFS, which makes it more convenient for this high-volume, dexterity-challenged patient to move to FCIG therapy.

Speaker Change: Quora's emphasis on our key accounts and partnerships, focus on leadership and clinical practice, and innovation in SCIG devices will continue to ensure we remain a preferred partner for customers and patients.

Linda Tharby: Moving on to international, we are pleased with our 40% growth this quarter and wanted to ride some insight into what we see as a continued geographic expansion opportunity ahead of us. There's approximately $60 million of SCIG Tam in markets outside of the US, altogether representing a larger Tam than the US market alone. We're currently marketed in 25 countries worldwide, but as you see in the graphic, our overall penetration into these markets has been relatively low. Our strategy has continued to work with pharmaceutical companies and distribution partners on tailored device and patient programs to both increase our penetration in current markets and drive increased penetration into new SCIG markets.

Linda Tharby: Moving on to international, we are pleased with our 40% growth this quarter and wanted to provide some insight into what we see as a continued geographic expansion opportunity ahead of us. There is approximately $60 million of SCIG TAM in markets outside of the U.S., altogether representing a larger TAM than the U.S. market alone.

Speaker Change: Moving on to international, we are pleased with our 40% growth this quarter and wanted to provide some insight into what we see as a continued geographic expansion opportunity ahead of us.

Speaker Change: There's approximately $60 million of SCIG TAM in markets outside of the U.S., altogether representing a larger TAM than the U.S. market alone.

Linda Tharby: We're currently marketed in 25 countries worldwide, but as you see in the graphic, our overall penetration into these markets has been relatively low. Our strategy is to continue to work with pharmaceutical companies and distribution partners on tailored device and patient programs to both increase our penetration in current markets and drive increased penetration into new SDIG markets. Our recent entry into Japan is one of these examples.

Speaker Change: We're currently marketed in 25 countries worldwide, but as you see in the graphic, our overall penetration into these markets has been relatively low.

Speaker Change: Our strategy is to continue to work with pharmaceutical companies and distribution partners on tailored device and patient programs to both increase our penetration in current markets and drive increased penetration into new SEIG markets.

Linda Tharby: Our recent entry to Japan is one of these examples. We look forward to continuing our geographic expansion efforts and believe it represents a tract of opportunity for growth.

Linda Tharby: We look forward to continuing our geographic expansion efforts and believe it represents an attractive opportunity for growth. The next slide represents our novel therapies pipeline. Sixteen collaborations in total, each one an opportunity to place a new drug on our label or expand existing drugs or innovations into new indications, which in total is a two point one million dollar, two point one million global patient population opportunity. The owl highlights the previously mentioned progress within the quarter, including the first clearance of pre-dementia in Japan, progression of our oncology asset collaboration, and our expanded nephrology indication, moving into a phase three treatment.

Speaker Change: Our recent entry to Japan is one of these examples. We look forward to continuing our geographic expansion efforts and believe it represents an attractive opportunity for growth.

Linda Tharby: The next slide represents our novel therapies pipeline. 16 collaborations in total, each one an opportunity to place a new drug on our label or expand existing drugs are innovations into new indications, which in total is a 2.1 million dollar 2.1 million global patients population opportunity. The all highlights indicate the prior mentioned progress within the quarter, including the first clearance of Freedom Edge in Japan, progression of our oncology asset collaboration and our expanded neurology indication moving into a pastry trials. In total, we now have six opportunities for new drugs to be cleared for use with the core platform by 2026, creating a path to a 10 to 20 million dollars of annualized commercial revenue.

Linda Tharby: The next slide represents our novel therapies pipeline. Sixteen collaborations in total, each one an opportunity to place a new drug on our label or expand existing drugs or innovations into new indications, which in total is a 2.1 million global patient population opportunity. I will now turn the call over to Tom to review our financial results.

Speaker Change: The next slide represents our Novel Therapies Pipeline.

Speaker Change: 16 collaborations in total, each won an opportunity to place a new drug on our label or expand existing drugs or innovations into new indications, which in total is a 2.1 million global patient population opportunity.

Speaker Change: The owl highlights indicate the prior mentioned progress within the quarter.

Speaker Change: including the first clearance of Freedom Edge in Japan, progression of our oncology asset collaboration, and our expanded nephrology indication moving into a phase 3 trial.

Linda Tharby: In total, we now have six opportunities for new drugs to be cleared for use with the Quoro platform by 2026, creating a path to 10 to 20 million dollars of annualized commercial revenue potential at the end of 2020. We are very pleased with the progress we made this quarter on multiple fronts. Double-digit growth in our core business, continued progress in our novel therapy pipeline, and increased operating leverage through focused execution from our team. I will now turn the call over to Tom to review our financial results.

Speaker Change: In total, we now have six opportunities for new drugs to be cleared for use with the Quoro platform by 2026, creating a path to $10 to $20 million of annualized commercial revenue potential at the end of 2026.

Linda Tharby: We are very pleased with our progress. We made this quarter on multiple fronts: double-digit growth in our core business, continued progress in our novel therapies pipeline, and increased operating leverage through focused execution from our team.

Speaker Change: We are very pleased with our progress we made this quarter on multiple fronts, double-digit growth in our core business, continued progress in our novel therapies pipeline, and increased operating leverage through focused execution from our team.

Tom Adams: I will now turn the call over to Tom to review our financial results.

Speaker Change: I will now turn the call over to Tom to review our financial results.

Tom Adams: Thank you, Linda, and thanks to everyone joining us this afternoon. We are very pleased with our second quarter results as we saw another quarter of double digit top line growth and our record revenue set in quarter net revenues for the second quarter were 8.4 million, a 22% increase compared to the prior year period. Our domestic core revenue grew 14% with net revenues of 6.2 million, driven by higher consumable volumes as a result of new patient starts share games. Our international core business grew 46% year over year, with revenues of 1.6 million driven by an improved IG supply versus the prior year, increased penetration and CIDP and FID approved indications, and continued geographic expansion.

Thomas Adams: Thank you, Linda, and thanks to everyone joining us this afternoon. We are very pleased with our second quarter results, as we saw another quarter of double-digit top-line growth and a record revenue-setting quarter. Net revenues for the second quarter were $8.4 million, a 22% increase compared to the prior year period. Our domestic core revenue grew 14% with net revenues of $6.2 million, driven by higher consumable volumes as a result of new patient starts and sharing. Our international core business grew 46% year over year with revenues of $1.6 million, driven by an improved IG supply versus the prior year, increased penetration in CIDP and SID Approved Indications, and Continued Geographic.

Tom Adams: Thank you, Linda, and thanks to everyone joining us this afternoon.

Tom Adams: We are very pleased with our second quarter results as we saw another quarter of double-digit top-line growth and a record revenue-setting quarter.

Tom Adams: Net revenues for the second quarter were $8.4 million, a 22% increase compared to the prior year period.

Tom: Our domestic core revenue grew 14% with net revenues of 6.2 million driven by higher consumable volumes as a result of new patient starts and sharing, and was $600,000, a 50% improvement compared to prior years. We continue to diversify our customer base and pipeline collaborations as we work on additional agreements that will bolster our future core commerce.

Tom Adams: Our domestic core revenue grew 14% with net revenues of $6.2 million driven by higher consumable volumes as a result of new patient starts and share gains.

Tom Adams: Our international core business grew 46% year-over-year with revenues of $1.6 million, driven by an improved IG supply versus the prior year, increased penetration in CIDP and SID approved indications, and continued geographic expansion.

Tom Adams: The 46% growth rate for international core included about 300,000 of exorid shipments as a result of residual effects from the BSI appeal that we discussed last quarter.

Thomas Adams: The 46% growth rate for International Corps included about 300,000 exonerated shipments as a result of residual effects from the BSI appeal that we discussed last quarter. Normalized growth excluding these orders was approximately 20%; novel therapies revenue, which we consider to be KORU pre-commercial launch collaboration revenue for services and clinical trial products, was $600,000, a 50% improvement compared to prior years, driven by the completion of three clinical trial orders for our pipeline collaboration.

Speaker Change: The 46% growth rate for International Corps included about 300,000 of accelerated shipments as a result of residual effects from the BSI appeal that we discussed last quarter.

Tom Adams: Normalized growth excluding these orders was approximately 20%. Our novel therapies revenue, which we consider to be co-ru pre-commercial launch collaboration revenue for services and clinical trial products, was 600,000. 50% improvement compared to prior year, driven by the completion of three clinical trial orders for our pipeline collaborations. We continue to diversify our customer base and pipeline collaborations as we work on additional agreements that will bolster our future core.

Tom Adams: Normalized growth, excluding these orders, was approximately 20%.

Tom Adams: Our novel therapies revenue, which we consider to be KORU pre-commercial launch collaboration revenue for services and clinical trial products, was $600,000, a 50% improvement compared to prior year.

Tom Adams: Driven by the completion of three clinical trial orders for our pipeline collaborations.

Thomas Adams: We continue to diversify our customer base and pipeline collaborations as we work on additional agreements that will bolster our future core commerce. Our first quarter gross margin improved to 65%, an 890 basis point increase compared to the prior year. As indicated in the bar graph on the right, the strong improvement was largely due to manufacturing efficiencies driven by the consolidation of our U.S. manufacturing system.

Tom Adams: We continue to diversify our customer base and pipeline collaborations as we work on additional agreements that will bolster our future core commercial business.

Tom Adams: of Commercial Business. Our first quarter gross margin improved to 65%, and 890 basis point increase compared to the prior year. As indicated on the bar graph on the right, the strong improvement was largely due to manufacturing efficiencies driven by the consolidation of our U.S. manufacturing sites. This marks the fourth consecutive quarter that we have achieved margins greater than 60%, and we continue to leverage operational excellence to identify and realize manufacturing improvements and efficiencies across our operations. Additionally, we have seen improved gross margins in novel therapies from our salesmen with higher levels of clinical trial orders, and in the U.S.

Tom Adams: Our first quarter gross margin improved to 65%.

Tom Adams: An 890 basis point increase compared to the prior year.

Tom Adams: As indicated on the bar graph on the right, the strong improvement was largely due to manufacturing efficiencies driven by the consolidation of our U.S. manufacturing sites.

Thomas Adams: This marks the fourth consecutive quarter that we have achieved margins greater than 60. And we continue to leverage operational excellence to identify and realize manufacturing improvements and efficiencies across our operations. Additionally, we have seen improved gross margins in novel therapies from our sales mix with higher levels of clinical trial orders. And in the U.S. core business, we have seen year-over-year increases in average selling prices. I'd like to note that in the quarter, gross margin was positively impacted by a $140,000 inventory evaluation adjustment that resulted in about 160 basis points of margin that we do not expect to recur in a second.

Tom Adams: This marks the 4th consecutive quarter that we have achieved margins greater than 60%.

Tom Adams: and we continue to leverage operational excellence to identify and realize manufacturing improvements and efficiencies across our operations.

Speaker Change: Additionally, we have seen improved gross margins in novel therapies from our sales mix with higher levels of clinical trial orders, and in the U.S. core business, we recognize year-over-year increases in average selling prices.

Tom Adams: core business, we recognize year-of-year increases in average sewing prices.

Tom Adams: I'd like to note that in the quarter, gross margin was positively impacted by a $140,000 inventory valuation adjustment that resulted in about 160 basis points of margin improvement that we do not expect to recur in the second half of the year. Moving on the cash, as of June 30th, we had an ending cash balance of 10.5 million, representing cash usage of $300,000 in the quarter. The overall level of cash usage in the quarter was partially driven by net losses of 200,000, which excludes non-cash items of stock compensation, depreciation, and memorization. This was at an improvement of 1.9 million over the prior year.

Tom: I'd like to note that in the quarter, gross margin was positively impacted by a $140,000 inventory evaluation adjustment that resulted in about 160 basis points of margin, partially offsetting these uses of cash for improvements and working capital of $300,000 with respect to our inventory levels. And we also brought down, driven by the majority of our capital investment outlay for a new production line and the related R&D project spending on innovation to bring new products.

Speaker Change: I'd like to note that in the quarter, gross margin was positively impacted by a $140,000 inventory valuation adjustment that resulted in about 160 basis points of margin improvement.

Thomas Adams: Moving on to cash, as of June 30, we had an ending cash balance of $10.5 million, representing cash usage of $300,000 in the. The overall level of cash usage in the quarter was partially driven by net losses of $200,000, which excludes non-cash items of stock compensation depreciation. This was an improvement of $1.9 million over the prior year.

Speaker Change: that we do not expect to recur in the second half of the year.

Speaker Change: Moving on to cash, as of June 30th, we had an ending cash balance of $10.5 million, representing cash usage of $300,000 in the quarter.

Speaker Change: The overall level of cash usage in the Corps was partially driven by net losses of $200,000, which excludes non-cash items of stock compensation, depreciation, and amortization.

Tom Adams: In addition, we used $300,000 of cash to invest in capital equipment for our new production lines, and we paid for our financing line for our D&O insurance. Partially offsetting these uses of cash for improvements in work in capital 300,000 with respect to our inventory levels, and we also brought down by a strong revenue quarter, which was partially offset by accounts receivable, driven by the same trend from the quarter. As we look ahead, our cash and cash flow targets remain on track, and we are substantially reducing our cash burdens since last year. In the first half of the year, we had cash usage of $1 million.

Thomas Adams: In addition, we used $300,000 of cash to invest in capital equipment for our new production line. And we paid for our financing line, partially offsetting these uses of cash for improvements and working capital of $300,000 with respect to our inventory levels. And we also brought down the cost by a strong revenue quarter, which was partially offset by accounts receivable driven by the same strength and ability. As we look ahead, our cash and cash flow targets remain on track, and we are substantially reducing our cash burdens since last year. In the first half of the year, we had a cash usage of $1 million.

Speaker Change: This was an improvement of 1.9 million over the prior year.

Speaker Change: In addition, we used $300,000 of cash to invest in capital equipment for our new production lines.

Speaker Change: And we paid for our financing line for our D&O insurance.

Speaker Change: Partially offsetting these uses of cash for improvements and working capital of $300,000.

Speaker Change: with respect to our inventory levels and we also brought down

Speaker Change: by a strong revenue quarter which was partially offset by accounts receivable.

Tom Adams: Driven by the same strength in the core.

Tom Adams: As we look ahead, our cash and cash flow targets remain on track, and we are substantially reducing our cash burden since last year.

Thomas Adams: We expect the second half cash usage to be higher than the first half, with peak spending coming in Q3. This is driven by the majority of our capital investment outlay for a new production line and the related R&D project spending on innovation to bring new products. We remain confident that we will end the year with a greater than $8 million cash balance, as well as being cash flow breakeven. I would also like to remind everyone that the ending cash balance of at least $8 million is exclusive of our undrawn $10 million credit facility that is being reserved for strategic growth.

Tom Adams: We expect the second half cash usage to be higher than our first half, with peak spending coming into 3. Driven by the majority of our capital investment outlay for a new production line, and the related R&B project spending on innovation to bring new products to market. We remain confident that we will end the year with a greater than $8 million cash balance, as well as being cash flow breakeven in the fourth quarter.

Tom Adams: In the first half of the year, we had a cash usage of $1 million. We expect the second half cash usage to be higher than our first half, with peak spending coming in Q3.

Tom Adams: driven by the majority of our capital investment outlay for a new production line and the related R&D project spending on innovation to bring new products to market.

Tom Adams: We remain confident that we will end the year with a greater than $8 million cash balance, as well as being cash flow break-even in the fourth quarter.

Tom Adams: I would also like to remind everyone that the ending cash balance of at least $8 million is exclusive of our undrawn $10 million credit facility that is being reserved for strategic growth capital. Moving on to 2024 guidance, when we originally set up guidance, we noted some key growth drivers that would enable our success. Those being made to high single-digit SCIG market growth, three new novel therapy collaborations, and underlying pre-filled syringe penetration of 20 to 25%. Now that we have two quarters behind us, we have delivered against our novel therapy milestones and are seeing a very healthy SCIG market with increasing pre-filled syringe demands.

Tom Adams: what

Tom Adams: I would also like to remind everyone that the ending cash balance of at least $8 million is exclusive.

Tom Adams: of our undrawn $10 million credit facility that is being reserved for strategic growth capital.

Thomas Adams: Moving on to 2024 guidance. When we originally set our guidance, we noted some key growth drivers that would enable our success, those being mid- to high-single-digit SCIG market growth, three new novel therapy collaborations, and underlying pre-filled syringe penetration of 20% to 25%. Now that we have two quarters behind us, we have delivered on our novel therapies, and milestones, and are seeing a very healthy SCIG market with increasing pre-filled syringe demand.

Tom Adams: yeah

Speaker Change: Moving on to 2024 guidance. When we originally set our guidance, we noted some key growth drivers that would enable our success, those being mid- to high-single-digit SCIG market growth,

Tom Adams: three new novel therapy collaborations and underlying pre-filled syringe penetration of 20 to 25 percent.

Tom Adams: Now that we have two quarters behind us, we have delivered against our novel therapies milestones and are seeing a very healthy SCIG market with increasing prefilled syringe demand. We are raising our revenue and gross margin guidance.

Tom Adams: We are raising our revenue in growth margins.

Tom Adams: Guidance. We expect the following for the remainder of the year: revenues of 32 million to 32 and a half million, up from the prior range of 31.2 to 30.2 million and representing 12 to 14 percent growth over prior year. And please note, we mentioned in our commentary on international sales that we saw growth levels in the second quarter that we do not anticipate to be recurring. Our updated guidance accounts for international sales, normalize for the rest of the year. As for growth margins, we now expect the full year growth margin between 61 and 62 percent.

Thomas Adams: We are raising our revenue in gross margin. We expect the following for the remainder of the year: revenues of $32 million to $32.5 million, up from the prior range of $31.2 to $30.2 million and representing 12 to 14% growth. Proprietary.

Tom Adams: We expect the following for the remainder of the year. Revenues of $32 million to $32.5 million, up from the prior range of $31.2 to $30.2 million, and representing 12% to 14% growth over prior year.

Thomas Adams: And please note, we mentioned in our commentary on international sales that we saw growth levels in the second quarter that we do not anticipate to be. Our updated guidance accounts for international sales normalizing for the rest of the year. As for gross margins, we now expect a full-year gross margin between 61 and 62. While we anticipate more pressure and margin from expanding into lower ASP regions, we continue to face inflationary pressure with our supply chain. We have managed to hold and improve our margin internally with additional manufacturing efficiencies and improved sales mix. Margin, and Novel Third.

Tom Adams: And please note, we mentioned...

Speaker Change: In our commentary on international sales that we saw growth levels in the second quarter that we do not anticipate to be recurring.

Speaker Change: Our updated guidance accounts for international sales normalizing for the rest of the year.

Tom: As for gross margins, we now expect a full-year gross margin between $61 and $62. We have managed to hold and improve our margin internally with additional manufacturing efficiencies and improved sales mix. $23.5 to $24 million in operating expenses. This ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of fiscal year 2014.

Speaker Change: As for gross margins, we now expect a full year gross margin between 61 and 62 percent.

Tom Adams: While we anticipate more pressure on margin from expanding into lower ASP regions, we continue to face inflationary pressure with our supply chain. We have managed to hold and improve our margin internally with additional manufacturing efficiencies and improved sales myths, margin, and novel therapies. Lastly, I mentioned before we expect to finish with an ending cash balance of more than $8 million, which includes approximately 23 and a half to 24 million in operating expenses. This ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of 24.

Speaker Change: While we anticipate more pressure and margin from expanding into lower ASP regions, we continue to face inflationary pressure with our supply chain. We have managed to hold and improve our margin internally with additional manufacturing efficiencies and improved sales mix.

Thomas Adams: Lastly, as I mentioned before, we expect to finish with an ending cash balance of more than $8 million, which includes approximately $23.5 to $24 million in operating expenses. This ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of fiscal 24. Our Credit Facility Reserve remains available to us for strategic growth opportunities but is not included in our estimates for 2024 ending. With that, I will now turn the call back to Linda for closing remarks. Thanks, Tom.

Speaker Change: Margin and Novel Therapies

Speaker Change: Lastly, I mentioned before we expect to finish with an ending cash balance of more than $8 million, which includes approximately

Speaker Change: twenty three and a half to twenty four million in operating expenses.

Speaker Change: This ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of 24.

Tom Adams: Our credit facility reserve remains available to us for strategic growth opportunities, but is not included in our estimates for 2024 ending cash balance.

Speaker Change: Our credit facility reserve remains available to us for strategic growth opportunities but is not included in our estimates for 2024 ending cash balance.

Linda Tharby: With that, I will now turn the call back to Linda for closing remarks.

Linda Tharby: Thanks, Tom. This quarter, we continue to execute on our business strategy, saw strong results as we did so, and will continue to focus in the back half. We've doubled digits outperforming a growing U.S.S.C.I.G. market and expanded our international reach. Our novel therapies business development efforts are becoming increasingly relevant as multiple pipeline drugs approached approval for use on our platform, the critical and flexion point for the business. We expect that we will see continued differentiation of porue in our Freedom Infusion platform with a submission for a new product and a new drug by the end of 2024.

Lenda: with that i will now turn the call back to lenda proclosing remarks

Linda Tharby: This quarter, we continue to execute on our business strategy, saw strong results as we did so, and will continue this focus in the back half. We grew double digits, outperforming a growing U.S. SCIG market, and expanded our international reach. Our novel therapies business development efforts are becoming increasingly relevant as multiple pipeline drugs approach approval for use on our platform, a critical inflection point for the business. We expect that we will see continued differentiation of QORU in our Freedom Infusion platform and a submission for a new product and a new drug by the end of 2024.

Linda Tharby: This quarter, we continue to execute on our business strategy, saw strong results as we did so, and we'll continue this focus in the back half. We also made meaningful progress in our operating leverage towards our goal of cash flow breakeven by the end of the year. These milestones are indicators of our progress towards our longer-term Vision 2026 goal.

Speaker Change: Thanks, Tom.

Speaker Change: This quarter, we continued to execute on our business strategy, saw strong results as we did so, and will continue this focus in the back half.

Speaker Change: We grew double digits, outperforming a growing U.S. SCIG market, and expanded our international reach.

Speaker Change: Our novel therapies business development efforts are becoming increasingly relevant as multiple pipeline drugs approach approval for use on our platform, a critical inflection point for the business.

Speaker Change: We expect that we will see continued differentiation of PORU in our Freedom Infusion platform with a submission for a new product and a new drug by the end of 2024. We also made meaningful progress in our operating leverage towards our goal of cash flow break-even by end of year.

Linda Tharby: We also made meaningful progress in our operating leverage towards our goal of cash flow breakeven by end of year. This strength across each of our strategic business areas generated record revenues and gives us the confidence to reiterate each of our 2024 milestones highlighted. These milestones are indicators of our progress towards our longer term vision 2026 goals.

Linda Tharby: We also made meaningful progress in our operating leverage towards our goal of cash flow breakeven by the end of the year. This strength across each of our strategic business areas generated record revenues and gives us the confidence to reiterate each of our 2024 milestones. These milestones are indicators of our progress towards our longer-term Vision 2026 goal. Our first half momentum is encouraging as we continue on our journey to transform the company into a global leader in large volume subcutaneous drug delivery.

Speaker Change: This strength across each of our strategic business areas generated record revenues and gives us the confidence to reiterate each of our 20 24 milestones highlighted.

Speaker Change: These milestones are indicators of our progress towards our longer-term Vision 2026 goals.

Linda Tharby: Our first half a momentum is encouraging as we continue in our journey to transform the company to a global leader in large volumes subcutaneous drug delivery.

Speaker Change: Our first half momentum is encouraging as we continue in our journey to transform the company to a global leader in large-volume subcutaneous drug delivery.

Linda Tharby: In closing, I'd like to thank everyone on the core of the medical team for her hard work. They do every day to create a superior patient experience and drive value for each of our stakeholders operator.

Linda Tharby: In closing, I'd like to thank everyone on the Corwin Medical Team for the hard work they do every day to create a superior patient experience and drive value for each of our stakeholders. Operator, I will now turn the call over to questions and answers.

Speaker Change: In closing, I'd like to thank everyone on the Corps of Medical Team for the hard work they do every day to create a superior patient experience and drive value for each of our stakeholders.

Unknown Attendee: I will now turn the call over for Q&A. Thank you.

Speaker Change: Operator, I will now turn the call over for Q&A.

Operator: Thank you. We will now be conducting the question and answer session. If you would like to ask a question, please press the star and then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.

Unknown Attendee: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star and then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press the star key and then two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. The first question we have is from Caitlin Cronin of CannaCore Genuity. Please go ahead.

Unknown Attendee: We will now be conducting the question and on position. If you would like to ask a question, please press star and then one on its telephone keypad. A confirmation turn will indicate your lines in the question queue. You may press star and then two if you would like to remove your question from the queue. Disciplines using Speedcake equipment. It may be necessary to pick up your handset before pressing the star keys.

John: and John. Thank you.

Operator: Sorry, Caitlin, go ahead.

Speaker Change: Thank you. We will now be conducting the question and answer session. If you would like to ask a question, please press star and then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker Change: You may press star and then 2 if you would like to remove your question from the queue.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Caitlin Cronin: First question we have is from Caitlin Cronin of Canaccord Genuity. Please go ahead. Hi, I think that's one of the good quarters, and thanks for taking the questions. Just to start, you mentioned pre-filter interpenetration as being a driver of the revenue guidance.

Speaker Change: The first question we have is from Caitlin Cronin of CannaCore Genuity. Please go ahead.

Caitlin Cronin: Hi, congratulations on the third quarter, and thanks for taking the question. Just to start, you mentioned pre-filled search penetrations as the driver of the revenue guidance. Given you raised the revenue guidance to where pre-filled search penetration is at this point, and jumping off of that, how is the progress on the 50 million pre-filled search launch earlier this year?

Pelin Crroonan: Hi, congrats on the third quarter, and thanks for taking the questions.

Pelin Crroonan: Just to start, you mentioned pre-filled syringe penetration being a driver of the revenue guidance. You know, given you raised the revenue guidance, where is pre-filled syringe penetration at this point?

Linda Tharby: It'll give a new raise to the revenue guidance where pre-filter interpenetration at this point, and jumping off of that, how is the progress on the 50-mill pre-filter into launch earlier this year? So thanks for the congrats. We're excited by the progress this quarter, specifically related to pre-filter engines. As you are aware, the leader in the US market, which is CSL, has launched now their entire pre-filter. We've built a syringe platform, which is compatible with our core devices. The market uptake is getting stronger through Q2 as their intention is to move their entire platform over to pre-filter engines by the end of the year.

Speaker Change: Jumping off of that, how is the progress on the 50 mil prefilled syringe launch earlier this year?

Linda Tharby: So thanks for the congratulations. We're excited by the progress this quarter, specifically related to prefilled syringes. As you are aware, the leader in the U.S. market, which is CSL, has now launched their entire prefilled syringe platform, which is compatible with our core devices. The market uptake is getting stronger through Q2 as their intention is to move their entire platform over to prefilled syringes by the end of the year. So we anticipate, again for us, this is a one-on-one driver from vials to prefills where we're seeing that conversion.

Speaker Change: So, thanks for the congrats. We're excited by the progress this quarter, specifically related to pre-filled syringes. As you are aware, the

Speaker Change: leader in the U.S. market, which is CSL, has launched now their entire prefilled syringe platform, which is compatible with our Quoro devices.

Speaker Change: The market uptake is getting stronger through Q2 as their intention is to move their entire platform over to pre-filled syringes by the end of the year.

Caitlin Cronin: So we anticipate, again for us, this is a one-on-one driver from vials to pre-filter, where we're seeing that conversion. We think that the longer term potential around pre-filter engines is the opportunity to bring more patients into the category as it's an easier format for the patient to use versus vials. So excited overall by our continued progress in the US market, and pre-filter engines is a format change for us. Got it.

Speaker Change: So, we anticipate, again, for us, this is a one-on-one driver from vials to pre-fills where we're seeing that conversion.

Linda Tharby: We think that the longer-term potential around prefilled syringes is the opportunity to bring more patients into the category as it's an easier format for the patient to use versus vials. We are so excited overall by our continued progress in the US market, and prefilled syringes are a format change.

Speaker Change: We think that the longer-term potential around pre-built syringes...

Speaker Change: is the opportunity to bring more patients into the category as it's an easier format for the patient to use versus vials.

Speaker Change: So, excited overall by our continued progress in the U.S. market and prefilled syringes is a format change for us.

Caitlin Cronin: Got it. Okay. And, you know, congrats on the Japan clearance. Do you plan to proceed to victory clearance in other geographies as well?

Caitlin Cronin: Okay, and congrats on the Japan clearance. Do you plan to pursue Q2 clearance in other geographies as well?

Speaker Change: Got it. Okay. And, you know, congrats on the Japan clearance. Do you plan to pursue key victory clearance in other geographies as well?

Caitlin Cronin: I'm sorry I missed the back end of that question. You plan to pursue Q2 clearance in other geographies other than Japan, since I believe that that's the first clearance you had for that drug. Or Cuba true specifically? Or is it just more expanded geographies? Okay.

Unknown Attendee: I'm sorry; I missed the back end of that question.

Caitlin Cronin: Do you plan to pursue QV2 clearance in other geographies other than Japan? Because I believe that that's the first clearance you've had for that drug.

Speaker Change: I'm sorry I missed the back end of that question.

Speaker Change: Do you plan to pursue cubicle clearance in other geographies other than Japan? Because I believe that that's the first clearance you've had for that drug.

Unknown Attendee: or Cuba Tru, specifically? Bye. Or is it just more expanded geographies? [inaudible] Okay. Sorry, Caitlin. Go ahead.

Speaker Change: or Cuba Truth specifically?

Speaker Change: Oh, or is it just more expanded geographies?

Linda Tharby: Sorry, Caitlin, go ahead. No, no, I mean, I was asking just about two victories specifically since I don't believe you are cleared in other regions for that drug. But I mean, if you want to talk about the broader feedback extension as well, that would test great. We are cleared for cubatory usage today, which is a Keda drug. We are cleared for that drug specifically in the US market and broadly internationally for that drug. So the significance overall for the Japan is just the entry into the Japan market. Yes, we did receive clearance with Cuba, true.

Speaker Change: Okay. I was asking about that.

Linda Tharby: No, no, no. I mean, I was asking just about Kuvichar specifically, since I don't believe they are cleared in other regions for that drug. But I mean, if you want to talk about the broader geographic extension as well, that would be great. We are cleared for Cubitri usage today, which is a CAIDA drug. We are cleared for that drug specifically in the U.S. market and broadly internationally for that drug, so the significance overall for Japan is just entry into the Japanese market.

Speaker Change: Sorry, Caitlin, go ahead.

Speaker Change: No, no, no. I mean, I was asking just about Key Victory specifically, since I don't believe you...

Speaker Change: are cleared in other regions for that drug. But, I mean, if you want to talk about the, you know, the broader geographic span.

Speaker Change: We are cleared for cubitry usage today, which is a CAIDA drug. We are cleared for that drug specifically in the U.S. market and broadly internationally.

Speaker Change: for that drug. So the significance overall for the Japan is just the entry into the Japan market. Yes, we did receive clearance with Cubitru. We also received clearance though with CSL's Hyzentra drug in that market, which

Linda Tharby: Yes, we did receive clearance with Cubitri. We also received clearance, though, with CSL's Hyzentra drug in that market, which accounts for about 95% of the overall Japanese market. So the significance for us, obviously, is Japan is a top 10 overall IG market. And we would anticipate that we will look for more significant approvals specifically in Latin America and Asia-Pac for Cuba True in the future. Great, thanks for taking the question

Linda Tharby: We also received clearance, though, with CSL's Hyzentra drug in that market, which compose about 95% of the overall Japanese market. So the significance for us obviously is Japan is a top 10 overall IG market, and we would anticipate that we will look for. More significant approvals, specifically in Latin America and Asia PAC, for Cuba True in the future.

Speaker Change: compose about 95% of the overall Japanese market.

Speaker Change: So, the significance for us, obviously, is Japan is a top 10 overall IG market, and we would anticipate that we will look for

Speaker Change: More significant approvals, specifically in Latin America and Asia-Pac, for Cuba True in the future.

Frank Takkinen: Great, thank you for taking any questions. The next question we have is from Frank Takkinen of Lake Street Capital. Please go ahead.

Speaker Change: Great. Thanks for taking the questions.

Unknown Attendee: The next question we have is from Frank Takkinen of Lake Street Capital. Please go ahead.

Speaker Change: that

Speaker Change: and many more. Thank you. Thank you.

Speaker Change: The next question we have is from Frank Takkinen of Lake Street Capital. Please go ahead.

Nelson Cox: Hey, this is Nelson Cox. I'm from Frank. Thanks for taking the questions, and great to see all the questions. I wanted to start with the expanded label for Zimbabwe, allowing patients to go straight to SCIG. Herd you mentioned it in the prepared remarks, but can you just walk us through that a bit more and how we should think about this impacting your business in the market overall? Sure, sure. Great question, and thank you for the note of congratulations. So all of the existing subcutaneous IG labels today call for the healthcare provider to start the patient on an initial dose of IB therapy before progressing to SCIG therapy.

Nelson Cox: Hey, this is Nelson Cox on for Frank. Thanks for taking the questions and great to see all the progress. I wanted to start with the expanded label for Zimbify, allowing patients to go straight to SCIG. I heard you mention it in the prepared remarks, but can you just walk us through that a bit more and how we should think about this impacting your business in the market overall? Sure, sure.

Speaker Change: Hey, this is Nelson Cox on for Frank. Thanks for taking the questions and great to see all the progress.

Nelson Cox: I wanted to start with the expanded label for Zimbify.

Speaker Change: allowing patients civgo straight to s cii heard you mentioned in the prer prepared remarks but can you just walk us through that a bit more and how we should think about this impactingin your business in the market overall your' sure great question and thank you for the note of congratulations so

Linda Tharby: Great question, and thank you for the note of congratulations. All of the existing subcutaneous IG labels today call for the healthcare provider to start the patient on an initial dose of IV therapy before progressing to SCIG therapy. Those labels have been in existence for well over a decade now, and so the significance of this is that GRIPPLES, with their Zembify label, was the first drug manufacturer to go after a label that allowed them to go straight to SCIG.

Speaker Change: All of the existing subcutaneous IG labels today call for the healthcare provider to start the patient on an initial dose of IV therapy before progressing to SCIG therapy. Those labels have been in existence for well over a decade now.

Linda Tharby: Those labels have been in existence for well over a decade now. And so the significance of this is gripples with the Zimbabwe label was the first drug manufacturer to go after a label that allowed them to go straight to SCIG. Well, this was becoming the standard of practice. It certainly was off-label usage. So we anticipate that this will just make it a much easier progression to go directly to SCIG.

Speaker Change: And so the significance of this is Gripples, with their Zembify label, was the first drug manufacturer to go after a label that allowed them to go straight to SCIG.

Linda Tharby: While this was becoming the standard of practice, it certainly was off-label usage, so we anticipate that this will just make it a much easier progression to go directly to SCIG. If I had a crystal ball, I'd love to give you an idea of what that might look like, but I think we're just going to have to see what happens in the coming quarters relative to healthcare practitioner use, and we will be sure to update you on that.

Speaker Change: While this was becoming the standard of practice, it certainly was off-label usage, so we anticipate that this will just make it a much

Speaker Change: um

Linda Tharby: If I had a crystal ball, I'd love to give you an idea of what that might look like, but I think we're just going to have to see what happens in the coming quarters relative to healthcare practitioner use, and we will be sure to update you on that.

Speaker Change: Easier progression to go directly to SCIG.

Speaker Change: If I had a crystal ball, I'd love to give you an idea of what that might look like, but I think we're just going to have to see what happens.

Speaker Change: in the coming quarters relative to health care practitioner use, and we will be sure to update you on that.

Linda Tharby: Perfect. And then maybe just following up on Japan, can you kind of talk about the strategy there and find the approval in July? How should we think about you guys entering that geography, and do you intend to go direct, or will you need to do any other work to ensure access?

Nelson Cox: Perfect. And then maybe just following up on Japan, can you kind of talk about the strategy there and, following the approval in July, how should we think about you guys entering that geography? And do you intend to go directly, or will you need to do any other work to ensure access?

Speaker Change: Perfect, and then maybe just following up on Japan, can you kind of talk about the strategy there and following the approval in July , how should we think about you guys entering that geography and do you intend to go direct or will you need to do any other work to ensure access?

Caitlin Cronin: Yeah, so this will be, we are still working to set up both our distributor and pharmaceutical company programs, so we do have an existing distributor relationship, but all of the details we're still working through. We see Japan as a significant market. We believe it'll be, over time, one of our top 10 markets for IG. We believe that it will largely be a consumables play initially, and this is largely an electronic pump market, so we will be focusing on the use of our consumables in that market. And don't see a big number in 2024, but see it adding about 5% to our overall growth number in 2025 for international.

Linda Tharby: Yeah, so this will be, we are still working to set up both our distributor and pharmaceutical company programs, so we do have an existing distributor relationship, but all of the details we're still working through. We see Japan as a significant market. We believe it'll be, over time, one of our top 10 markets for IG. We believe that it will largely be a consumables play initially, and this is largely an electronic pump market, so we will be focusing on the use of our consumables in that market. And don't see a big number in 2024, but see it adding about 5% to our overall growth number in 2025 for international.

Linda Tharby: Yeah, so this will be we are still working to set up both our distributor and pharmaceutical company programs. So we do have an existing distributor relationship, but all of the details we're still working through. We see Japan as a significant market. We believe it'll be, over time, one of our top 10 markets for IG. We believe that it will largely be a consumables play initially. That is largely an electronic pump market. So we will be focusing on the use of our consumables in that market.

Unknown Attendee: Yeah.

Speaker Change: Yeah.

Speaker Change: So, this will be, we are still working to set up both our distributor and pharmaceutical company programs, so we do have an existing distributor relationship.

Speaker Change: But all of the details, we're still working through. We see Japan as a significant market. We believe it'll be, over time, one of our top ten markets for IG.

Speaker Change: We believe that it will largely be a consumables play initially, and it is largely an electronic pump market. So we will be focusing on the use of our consumables in that market.

Linda Tharby: And don't see a big number in 2024, but see it adding about 5% to our overall growth number in 2025 for international.

Speaker Change: And don't see a big number in 2024, but see it adding about 5% to our overall growth number in 2025 for international.

Nelson Cox: Great. Thanks, guys, and congrats again. Thank you.

Unknown Attendee: Great. Thanks, guys, and congrats again. Thank you.

Speaker Change: Thanks guys and congrats again. Thank you.

Unknown Attendee: Ladies and gentlemen, just a reminder: if you would like to ask a question, you're welcome to press star. One.

Operator: Ladies and gentlemen, just a reminder, if you would like to ask a question, you're welcome to press star and then 1.

Unknown Attendee: Ladies and gentlemen, just a reminder, if you would like to ask a question, you're welcome to press star and then 1. The next question we have is from Chase Knickerbocker of Craig Hallam Capital Group. Please go ahead.

Speaker Change: Ladies and gentlemen, just a reminder, if you would like to ask a question, you're welcome to press star and then 1.

Chase Knickerbocker: The next question we have is from Chase Knickerbocker of Craig Hallum Capital Group. Please go ahead. Good afternoon. Thanks for taking the questions, and I just want to pass along my congratulations as well. Maybe just first from me.

Speaker Change: The next question we have is from Chase Knickerbocker of Craig Hallam Capital Group. Please go ahead.

Chase Knickerbocker: Good afternoon. Thanks for taking the questions. And I just want to pass along my congratulations as well. Maybe just first for me, Linda, if you had to say what's driving predominantly the outperformance here in the first half of the year, would you say it's more new patient starts or sub-Q conversions from IV? Thanks.

Unknown Attendee: Good afternoon. Thanks for taking the questions. And I just want to pass along my congratulations as well. Maybe just first for me, Linda, if you had to say what's driving predominantly the outperformance here in the first half of the year, would you say it's more new patient starts or sub-Q conversions from IV? Thanks.

Chase Knickerbocker: Good afternoon. Thanks for taking the questions, and I just want to pass along my congratulations as well. Maybe just first from me, Linda, if you had to say what's driving predominantly the outperformance here in the first half of the year, would you say it's more new patient starts or sub-Q conversions from IV? Thanks.

Linda Tharby: Linda, if you had to say what's driving predominantly the outperformance here in the first half of the year, would you say it's more new patient starts or subcue conversion from Ivy? Thanks. So I would say it's a combination. I mean, the performance of the overall subcutaneous IG market is driving new patient starts, but, you know, certainly the growth in the front half, the performance in our international and our domestic core businesses are doing incredibly well, as well as, you know, our business development efforts and novel therapy. So strength and all three is what we see driving the front half growth.

Linda Tharby: So I would say it's a combination. I mean, the performance of the overall subcutaneous IG market is driving new patient starts, but certainly, the growth in the front half, the performance in our international and our domestic core businesses is doing incredibly well, as well as our business development efforts and novel therapies. So strength in all three is what we see driving the front half.

Speaker Change: So I would say it's a combination, I mean the performance of the overall subcutaneous IG market is driving new patient starts.

Speaker Change: but

Speaker Change: You know, certainly the growth in the front half, the performance in our international and our domestic core businesses are doing incredibly well, as well as, you know, our business development efforts and novel therapies. So strength in all three is what we see driving the front half growth.

Linda Tharby: And maybe just on kind of the pre-filled benefit that we could get from CSL can't win the vile. Do you think we've seen some of that benefit already as part of the kind of performance in the first half, maybe a benefit from some increase kind of pre-filled conversion or, you know, maybe just some thoughts there. Thanks. Yeah, I think the pre-filled launches is going per our internal plans to date. I think we will see more upside as we get into some of our new product innovations that one of them I mentioned coming towards the back half of the year and the other one coming in 2025, which are tailored to benefit the pre-filled users.

Chase Knickerbocker: And maybe just on kind of the pre-filled benefit that we could get from CSL canceling the vials. Do you think we've seen some of that benefit already as part of the kind of outperformance in the first half? Maybe a benefit from some increased kind of pre-filled conversion or, you know, maybe just some thoughts there. Thanks. Yeah, I do.

Speaker Change: And maybe just on kind of the pre-filled benefit that we could get from CSL canceling the vials. Do you think we've seen some of that benefit already as part of the kind of outperformance in the first half? Maybe a benefit from some increased kind of pre-filled conversion or maybe just some thoughts there? Thanks.

Linda Tharby: Yeah, I think the pre-filled launch is going as per our internal plans to date. I think we will see more upside as we get into some of our new product innovations, one of them I mentioned coming towards the back half of the year, and the other one coming in 2025, which are tailored to benefit the pre-filled users. So, I think we'll see more then, and I think the first half is performing as expected.

Speaker Change: Yeah, I think the pre-filled launch is going per our internal plans to date. I think we will see more upside as we get into some of our new product innovations, that one of them I mentioned coming towards the back half of the year.

Speaker Change: and the other one coming in 2025, which are tailored to benefit the prefilled users. So I think we'll see more then, and I think the first half is performing as per our expectations.

Linda Tharby: So I think we'll see more then. And I think the first half is performing as per our expectations. Yeah, so it sounds like, you know, overall, it's going to be more of the growth expectations are kind of unchanged. You know, things are going as you expected.

Chase Knickerbocker: Yeah, so it sounds like, you know, overall S&P market growth expectations are kind of unchanged, you know, things are going as you expected. Maybe just speak to guidance implying a little bit of a step down sequentially from here in revenue from the first half of the year into the second half. Should we think of this as kind of conservatism? Is there some seasonality we should think about this year?

Speaker Change: yeah so itsounds like you know overallas market growth expectations are kind of unchange you know things are going if you expected maybe just speak to guide implying a little bit of a stepdown sequentially from here in revenue from the first half of year and into the second half should we think this is kind of conservatism thosethere seasonalleweshould think about this year

Linda Tharby: Maybe just speak to guidance implying a little bit of a step down sequentially from here and revenue from the first half of the year into the second half. Should we think of this as kind of conservatism, as there's some seasonality we should think about this year? Yeah, so thank you. Great question. So yes, Q3 traditionally we see a bit of a slowdown both here in the US and internationally as the patients tend to slow down overall new patient starts, both from the healthcare provider perspective and from the patient perspective. So the second thing is, as Tom mentioned to you, we had this $300,000 that was pulled into quarter two, accelerated due to the prior issue with the BSI regulatory clearance, which we since cleared.

Linda Tharby: Yeah, so thank you. It's a great question.

Speaker Change: yeah so thank you great question

Speaker Change: So, yes.

Speaker Change: Q3, traditionally, we see a bit of a slowdown, both here in the U.S. and internationally as vacations tend to slow down over all new patient starts, both from the healthcare provider perspective and from the patient perspective.

Linda Tharby: So yes, traditionally, Q3, we see a bit of a slowdown both here in the U.S. and internationally as vacations tend to slow down overall new patient starts, both from the healthcare provider perspective and from the patient perspective. The second thing is, as Tom mentioned to you, we had this $300,000 that was pulled into quarter two accelerated due to the prior issue with the BSI regulatory clearance, which we've since cleared. And then, you know, finally, we always have to consider the timing of novel therapy revenues, which is our intention to complete earlier, but working together with our pharmaceutical collaborations sometimes takes longer than we expected.

Speaker Change: The second thing is, as Tom mentioned to you, we had this $300,000 that was pulled into Quarter 2 accelerated.

Tom Adams: due to the prior issue with the BSI regulatory clearance which we've since cleared.

Linda Tharby: And then, you know, finally, we always have to consider the timing of novel therapies, revenues that are intention to complete earlier, but working together with our pharmaceutical collaborations sometimes takes longer than we expected. So I think we look at all three of those things, and of course, I wouldn't call it conservative, but I would say that we certainly hope that we have opportunities to outperform in the back half with both further international penetration and anti-collaboration timing.

Speaker Change: And then, you know, finally, we always have to consider timing of novel therapies, revenues that

Speaker Change: Our intention to complete earlier, but working together with our pharmaceutical collaborations sometimes takes longer than we expected

Linda Tharby: So I think we look at all three of those things. And, of course, I wouldn't call it conservative, but I would say that we certainly hope that we have opportunities to outperform in the back half with both further international penetration and NT collaboration.

Speaker Change: So, I think we look at all three of those things, and of course, I wouldn't call it conservative, but I would say that we certainly hope that we have opportunities to outperform in the back half with both further international penetration and NT collaboration time.

Unknown Attendee: Got it, then just lots from Melinda. That was helpful.

Chase Knickerbocker: And then, just last, for me, Linda. That was helpful. Maybe speak to kind of any plans that you have from a commercialization perspective on these new novel therapies. They're going to be launching into, you know, you guys are going to be launching into the infusion clinics here that deliver those patient-administered novel therapies, the oncology asset in a rare disease. Maybe just speak to kind of how you guys expect to kind of target that market, maybe early commercial plans. Thanks. So sure, with any of our launches on our

Linda Tharby: Maybe speak to kind of any plans that you have from a commercialization perspective on these new novel therapies that are going to be launching into, you know, you guys are going to be launching into the infusion clinics here that deliver those patient-administered novel therapies, the oncology asset and the rare disease. Maybe just speak to kind of how you guys expect to kind of target that market, maybe early commercial plans. Thanks. So, with any of our launches on our label, the most important early partnership we have is with the pharmaceutical company itself. So we work closely with them on their launch plans and ensuring that we understand their target and messaging, and we work with them to figure out where the right target and call points, whether that's a country or a specific clinic.

Linda Tharby: And then just last for me, Linda, that was helpful, maybe speak to kind of any plans that you have from a commercialization perspective on these new novel therapies that are going to be launching into

Speaker Change: you know guysaregoing to be launching into the fut clinics here that deliver those patientsent administered novel therapies the oncology asset and these maybe just speak tokind of how you guys expect to kind of target that market maybe early commercial plansants s

Linda Tharby: So sure, with any of our launches on our label, the most important early partnership we have is with the pharmaceutical company itself. So we work closely with them on their launch plans and ensure that we understand their targeted messaging, and we work with them to figure out where the right target and call points are, whether that's a country or a specific clinic. And second, um...

Speaker Change: Yeah.

Speaker Change: So, sure, with any of our launches on our label, the most important early partnership we have is with the pharmaceutical company itself.

Speaker Change: So we work closely with them on their launch plans and ensuring that we understand their targeted messaging and we work with them to figure out where the right target and call points, whether that's a country or a specific clinic.

Linda Tharby: There's new drugs we talked about. Second, we many of the specialty pharmacies that we work with today service the rare disease drug that I reference, which will plan to file by the end of Q4. And then for oncology, we expect that we will work with a distributor who focuses and specializes in oncology clinics for that market. But we're in the process of finalizing our commercialization plans for that drug launch. For our launch with that drug is already.

Speaker Change: So that's first, and we'll continue those efforts on those new drugs we talked about.

Linda Tharby: Many of the specialty pharmacies that we work with today service the rare disease drug that I referenced, which we'll plan to file by the end of Q4. And then for oncology, we expect that we will work with a distributor who focuses on and specializes in oncology clinics for that market. But we're in the process of finalizing our commercialization plans for that drug launch, for our launch with that drug, the drug is already.

Speaker Change: Many of the specialty pharmacies that we work with today service the rare disease drug that I referenced, which we'll plan to file by the end of Q4. And then for oncology, we expect that we will work with a distributor who focuses and specializes in oncology clinics.

Speaker Change: for that market. But we're in the process of finalizing our commercialization plans for that drug launch.

Anderson Schock: Thank you. The next question we have is from Anderson's Cook of Bureau of Securities. Please go ahead.

Speaker Change: For our launch with that drug, the drug is already...

Speaker Change: Thank you.

Unknown Attendee: The next question we have is from Anderson Schock of Burelai Securities. Please go ahead.

Speaker Change: The next question we have is from Anderson Skok of Biorally Securities. Please go ahead.

Anderson Schock: Hi, this is Anderson on for Kyle. Congratulations on the great quarter, and thank you for taking our questions. So first, do you have any updates on the potential expansion into Canada? I know there were some delays initially, but how is that study progressing, and when should we expect to see approval here? Yeah, so we continue in our discussions with the pharmaceutical partners in those markets, so that is progressing extremely well. And the launch is really contingent upon our launch of a couple of new products. And we expect those to be completed in early 2025, so likely see a launch into Canada occur in that 2025 timeframe.

Anderson Schock: Hi, this is Anderson speaking on behalf of Kyle. Congratulations on a great quarter, and thank you for taking our questions. So first, do you have any updates on the potential expansion into Canada? I know there were some delays initially, but how is that study progressing, and when should we expect to see approval here?

Anderson Skok: Hi, this is Anderson on for Kyle. Congratulations on the great quarter and thank you for taking our questions.

Anderson Skok: So, first, do you have any updates on the potential expansion into Canada? I know there were some delays initially, but how is that study progressing and when should we expect to see approval here?

Unknown Speaker: Yes, so we continue our discussions with the pharmaceutical partners in those markets, and that is progressing extremely well.

Linda Tharby: Yeah, so we continue our discussions with the pharmaceutical partners in those markets, and that is progressing extremely well.

Anderson Schock: And the launch is really contingent upon our launch of a couple of new products, and we expect those to be completed in early 2025. So we should likely see a launch into Canada occur in that 2025 time.

Speaker Change: Yeah, so we continue in our discussions with the pharmaceutical partners in those markets. So that is progressing extremely well.

Unknown Speaker: And the launch is really contingent upon our launch of a couple of new products, and we expect those to be completed in early 2025. So, we should likely see a launch into Canada occur in that 2025 timeframe.

Anderson Skok: And the launch is really contingent upon our launch of a couple of new products and we expect those to be completed in early 2025, so likely see a launch into Canada occur in that 2025 timeframe.

Anderson Schock: Okay, great.

Linda Tharby: Okay, great, thank you. And then could you just give us some more color on the Schott Pharmaceutical Collaboration? Will they be developing new therapies for use on the Freedom Pumps? And just how should we think about the potential revenue contribution from this collaboration?

Linda Tharby: Thank you. And then could you just give us some more color on the shot pharmaceutical collaboration? Will they be developing new therapies for use on the Freedom pumps and just how should we think about potential revenue contribution from this collaboration?

Speaker Change: okay great thank you and then could you just give us some more color on the shot pharmaceuticals to collaboration will they be developing new therapies for use on the freedom pumps and just how should we think about potential revenue contribution from this collaboration

Linda Tharby: So, you know, first, I'll just reiterate that Shot is the world's largest pre-filled device manufacturer in the world, so quite excited to announce this partnership. The partnership will focus on the use of our Freedom System platform with their, with their pre-filled syringes. We will focus on pipelines and looking at who we're working with jointly to ensure that the end customer, which is the pharmaceutical customer, is getting the best service of a combined device, which includes our Freedom platform and their pre-filled device. We think there will be many advantages to the convenience and time required to infuse with pre-filled syringes with this platform.

Unknown Speaker: You know, first, I'll just reiterate that Schott is the world's largest prefilled device manufacturer in the world. So, I'm quite excited to announce this partnership. The partnership will focus on the use of our Freedom System platform with their devices. We intend to do this at joint conferences, joint business calls, etc. between the two companies.

Linda Tharby: So... you know, first, I'll just reiterate that this shot is the world's largest.

Speaker Change: So.

Speaker Change: First, I'll just reiterate that Schott is the world's largest pre-filled device manufacturer in the world. So, quite excited to announce this partnership. The partnership will focus on the use of our Freedom System platform with their

Unknown Speaker: with their pre-filled syringes.

Unknown Speaker: We will focus on pipelines and looking at who we're working with jointly to ensure that the end customer, which is the pharmaceutical customer, is getting the best service of a combined device, which includes our Freedom platform and their prefilled device. We think there will be many advantages to the convenience.

Speaker Change: and time required to infuse with prefiled ringes with this platform

Linda Tharby: We intend to do this at joint conferences, joint business calls, et cetera, with between the two companies.

Speaker Change: We intend to do this at joint conferences, joint business calls, etc. between the two companies.

Linda Tharby: So, too early to talk about commercial potential. We're just at the start of the collaboration, but I would expect to have more of an update on that in 2020. 25.

Speaker Change: So, too early to talk about commercial potential, we're just at the start of the collaboration, but I would expect to have more of an update on that in 2025.

Anderson Schock: Okay, great. Thank you, that's all from us.

Speaker Change: Okay, great. Thank you. That's all from us.

Unknown Attendee: Ladies and gentlemen, we have reached the end of the question-and-answer session, and with that, we conclude today's conference call. Thank you for joining us.

Speaker Change: ladies and gentlemen we have reached the end of the question and ans'posician and with that we conclude today's conference call thank you for jowinining us you may now disconnect your line

Unknown Attendee: You may now disconnect your line.