Q2 2024 Fennec Pharmaceuticals Inc Earnings Call

Operator: Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceutical's second quarter 2024 earnings and corporate update conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded. Now I'd like to turn the comments over to Fennec's Chief Financial Officer, Robert Andrade. Please go ahead.

Operator: Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceutical's second quarter 2024 earnings and corporate update conference call. At this time, all participants are in a listen-only mode.

Good morning, ladies and gentlemen, and welcome to <unk> Pharmaceuticals second quarter 2024 earnings and corporate update conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions on how to participate will be given at that time.

Operator: Later, we will conduct a question-and-answer session, and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded. Now, I'd like to turn the comments over to Fennec's Chief Financial Officer, Robert Andrade. Please go ahead.

As a reminder, today's conference call is being recorded.

I'd like to turn the conference over to Fedex Chief Financial Officer, Robert Please go ahead.

Robert Andrade: Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceutical's second quarter 2024 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our newly appointed Chief Executive Officer and Board Member, Jeff Hackman. Jeff joined Fennec on August 5th and brings more than 30 years of commercial leadership, including oversight of more than 10 product launches across a wide range of therapeutic areas and markets. Importantly, Jeff has successfully commercialized products that are specifically relevant to the PEDMARC market.

Robert Andrade: Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceutical's second quarter 2024 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our newly appointed Chief Executive Officer and Board Member, Jeff Hackman. Jeff joined Fennec on August 5th and brings more than 30 years of commercial leadership, including oversight of more than 10 product launches across a wide range of therapeutic areas and markets.

Robert: Thank you operator, and good morning, everyone.

Speaker Change: We appreciate you joining us today for Fedex Pharmaceuticals second quarter 2024 earnings Conference call.

Speaker Change: During which we will review our financial results as well as provide a general business update.

Speaker Change: Joining me. This morning is our newly appointed Chief Executive Officer, and Board member Jeff Hoffman.

Speaker Change: Jeff joined <unk> on August <unk>.

Speaker Change: It brings more than 30 years of commercial leadership, including oversight of more than 10 product launches across a wide range of therapeutic areas and markets.

Speaker Change: Importantly.

Jeff Hoffman: Jeff has successfully commercialized products that are specifically relevant to the pet Mark markets.

Robert Andrade: Now, before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from those discussed in the forward-looking statement. References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statement.

Robert Andrade: Importantly, Jeff has successfully commercialized products that are specifically relevant to the PEDMARC market. Now, before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from those discussed in the forward-looking statements. References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

Speaker Change: Now before we begin I would like to remind you that during this call. The company will be making forward looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward looking statements.

Speaker Change: References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U S Securities and Exchange Commission.

Speaker Change: In addition, any forward looking statements made on this call represent our views only as of today.

Speaker Change: Should not be relied upon as representing our views as of any subsequent date.

Robert Andrade: We specifically disclaim any obligation to update or revise any forward-looking statement. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days. And now, it gives me pleasure, to turn the call over to Jeff Hackman.

Speaker Change: We specifically disclaim any obligation to update or revise any forward looking statements.

Robert Andrade: This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days. Now, it gives me pleasure to turn the call over to Jeff Hackman. Thank you, Robert, and good morning, everyone. I'm incredibly excited to lead Fennec in this new role, and I look forward to working with this team to direct the organization through its continued growth efforts. Before I introduce myself,

Speaker Change: This conference call is being recorded for audio rebroadcast on <unk> website, Www Dot pharma dot com.

Speaker Change: Where it will be available for the next 30 days and now gives me pleasure to turn the call over to Jeff.

Jeff Hackman: Thank you, Robert, and good morning, everyone. I'm incredibly excited to lead Fennec in this new role, and I look forward to working with this team to direct the organization through its continued growth. Before I introduce myself, I would like to thank Rosti for his dedication and leadership since 2009. He's been critical not only to the success of Fennec but to bringing a much needed therapy to the pediatric oncology population that was at risk for irreversible hearing loss, which can have a profound, lifelong impact, as you know, on these.

Jeff Hoffman: Thank you Robert.

Jeff Hoffman: And good morning, everyone.

Jeff Hoffman: I'm incredibly excited to lead fennec in this new role and I look forward to working with this team to direct the organization through its continued growth efforts.

Speaker Change: Before I introduce myself.

Robert Andrade: I would like to thank Rosti for his dedication and leadership since 2009. He's been critical not only to the success of Fennec but to bringing a much needed therapy to the pediatric oncology population that was at risk for irreversible hearing loss, which can have a profound lifelong impact, as you know, on these patients. On behalf of everyone at Fennec, we're pleased we will be able to continue to benefit from Rosti's experience and knowledge as we enter into the next chapter.

Speaker Change: I would like to thank Rossi for his dedication and leadership since 2009.

Speaker Change: He has been critical not only to the success of panic, but bringing a much needed therapy to the pediatric oncology population.

Speaker Change: That was at risk for irreversible hearing loss.

Speaker Change: Which can be a profound lifelong impact as you know on these patients on behalf of everyone. At Phoenix. We're pleased we will be able to continue to benefit from Rothesay his experience and knowledge as we enter into the next chapter.

Jeff Hackman: On behalf of everyone at Fennec, we're pleased we will be able to continue to benefit from Rosti's experience and knowledge as we enter into the next phase of history. Let me talk a little bit about myself.

Jeffery Hackman: Let me talk a little bit about myself. My tenure in oncology spans the last 12 years or so with companies like Sigma Tau, Baxalta, Shire, and USA Pharma, where I was responsible for the US commercial organization and managing the company's product portfolios in multiple franchises, generating billions in revenues over those years. As Robert mentioned, I have specific experience commercializing oncology products that are specifically relevant to PEDMARC markets and in the pediatric oncology community, where I've spent a lot of time and I'm passionate about. From my very first early interactions with the team here at Fennec through my last week here, it's clear to me that we have access to an incredible pool of talent at Fennec.

Jeff Hackman: My tenure in oncology spans the last 12 years or so with companies like Sigma Tau, Baxaltus, Shire, and USA Pharma, where I was responsible for the US commercial organization and managing the company's product portfolios in multiple franchises, generating billions in revenues over those years. As Robert mentioned, I have specific experience commercializing oncology products that are specifically relevant to PEDMARC markets and in the pediatric oncology community, where I've spent a lot of time, and I'm passionate.

Speaker Change: Let me talk a little bit about me my tenure in oncology span Alaska.

12 years, or so with companies like Sigma Tau Baxalta Shire and use of pharma, where I was responsible for the U S commercial organizations and managing the company's product portfolios in multiple franchises generating billions in revenues over those years as Robert mentioned I have specific.

Speaker Change: Experience commercializing oncology products that are specifically relevant to petsmart markets.

Speaker Change: And in the pediatric oncology community, where Ive spent a lot of time and I'm passionate about.

Jeff Hackman: From my very first early interactions with the team here at Fennec through my last week here, it's clear to me that we have access to an incredible pool of talent at Fennec. Their dedication, expertise, and passion are evident, and I'm confident that together we can work to fill any gaps and address any needs to drive our organization forward. Now turning to our second quarter 2024 financial results, all of which were outlined in our earnings press release issued earlier this morning before the call.

Speaker Change: From my very first early interactions with the team here at Phoenix.

Speaker Change: Through my last week here, it's clear to me that we have access to an incredible pool of talent at Fennec <unk>.

Jeffery Hackman: Fennec's dedication, expertise, and passion are evident, and I'm confident that together we can work to fill any gaps and address any needs to drive our organization forward. Now turning to our second quarter 2024 financial results, all of which were outlined in our earnings press release issued earlier this morning before the call. We will also discuss ongoing commercial launch efforts and the progress we're making with PEDMARC in the U.S. and abroad following the exclusive licensing agreement announcement we executed in March with Norgene to commercialize PEDMARC-C in Europe, Australia, and New Zealand. In the second quarter, PEDMARC delivered net revenues of $7.3 million. We believe that

Speaker Change: Fedex dedication expertise and passion are evident and I'm confident that together, we can work to fill any gaps and address any needs to drive our organization forward.

Speaker Change: Now turning to our second quarter 2024 financial results.

Speaker Change: All of which were outlined in our earnings press release.

Speaker Change: Issued earlier this morning before the call. We will also discuss ongoing commercial launch efforts and the progress, we're making with pet mark in the U S and abroad. Following exclusive licensing agreement announcement, we executed in March with nor gene to commercialize <unk> in Europe, Australia and.

Jeff Hackman: We will also discuss ongoing commercial launch efforts and the progress we're making with PEDMARC in the U.S. and abroad following the exclusive licensing agreement announcement we executed in March with Norgene to commercialize PEDMARC-C in Europe, Australia, and New Zealand. In the second quarter, PEDMARC delivered net revenues of $7.3 million.

Speaker Change: New Zealand.

In the second quarter <unk> delivered net revenues of $7 3 million.

Jeff Hackman: We believe that there were several key milestones that we achieved recently that will enable us to accelerate patient access and build off the second quarter. In May, the Office of New Drugs at the FDA added a safety communication issued by CDER, Professional Affairs and Stakeholder Engagement Staff, to PEDMARC's approval on the FDA page. Now that substitutions pose potential health risks, Fennec continues to diligently work with the FDA to address this issue.

Speaker Change: We believe.

Jeffery Hackman: There were several key milestones that we achieved recently that will enable us to accelerate patient access and build off the second quarter. In May, the Office of New Drugs at the FDA added a safety communication issued by CDER, Professional Affairs and Stakeholder Engagement Staff, to PEDMARC's approval on the FDA website. Now it is clear that substitutions pose potential health risks, Fennec continues to diligently work with the FDA to address this issue. During the second quarter, notifications were sent outlining the FDA's non-substitution status, payer.

Speaker Change: There were several key milestones that achieved that we achieved recently that will enable us to accelerate patient access and build off the second quarter in may the office of new drugs at the FDA added a safety communication issued by Cedar professional affairs and stakeholder.

Speaker Change: Their engagement staff to petsmart approval on the SBA page now it is clear that substitution suppose potential health risks.

Speaker Change: <unk> continues to diligently work with the FDA to address this issue during the second quarter notifications were sent outlining the FDA non substitution status.

Jeff Hackman: During the second quarter, notifications were sent outlining the FDA non-substitution status, payer, recipients included Medicare administrative contractors, Medicare Advantage, Managed Medicaid, and commercial payers. Provider recipients included all state oncology societies, the top 20 health systems, including children's hospitals, and more than 360 oncology practices, which are community-based or hospital-owned.

Jeffery Hackman: Recipients included Medicare administrative contractors, Medicare Advantage, Managed Medicaid, and commercial payers. Provider recipients included all state oncology societies, the top 20 health systems, including children's hospitals, and more than 360 oncology practices. These are community-based or hospital-owned. Additionally, as of April 1st, our J code was issued, and we fully resolved this with CMS amending it. Specified Pedmore.

Speaker Change: Payer recipients included Medicare administrative contractors.

Speaker Change: Medicare advantage managed Medicaid and commercial payers.

Provider recipients included Allstate oncology societies, the top 20 health systems, including children's hospitals and more than 360 oncology practices. These are community based or hospital owned.

Jeff Hackman: Additionally, as of April 1st, our J code was issued, and we fully resolved this with CMS amending it, specified head. Now that this change is implemented, we are seeing uptake that we believe will continue to improve the quarters as we move forward. Further, and of great importance, the NCCN recently modified and updated their AYA guidelines for pets. The guidelines removed pediatric-specific wording and allowed for patients up to 39 years of age, and two replaced cisplatin with platinum.

Speaker Change: Additionally, as of April 1st our J code was issued.

Speaker Change: We fully resolved this with CMS amending it to specify head Mark now.

Jeffery Hackman: Now that this change is in effect, we are seeing uptake that we believe will continue to improve in the quarters as we move forward. Further, and of great importance, the NCCN recently modified and updated their AYA guidelines for PEDMARC. The guidelines removed pediatric-specific wording and allowed for patients up to 39 years of age, and two replaced cisplatin with platinum.

Speaker Change: Now that this change is affected we are seeing uptake that we believe will continue to improve the quarters as we move forward.

Speaker Change: Further and of great importance to NCC and recently modified and updated their guidelines for pet Mark the guidelines removed pediatric specific wording and allowed for patients up to 39 years of age.

Speaker Change: And to replace cisplatin with platinum.

Jeffery Hackman: We believe this allows PEDMARC to access a broader patient population within the auto toxicity prevention application. Now that the NCCN-AYA guidelines have been modified, we've submitted PEDMARC data packages to the remaining targeted clinical drug compendia and anticipate that these updates to the compendia will be completed by the end of this quarter. So, with all these recent milestones achieved, we remain optimistic and excited about the second half of the year for Fennec, given the foundation that we put in place during the first 18 months of the launch.

Jeff Hackman: We believe this allows PEDMARC to access a broader patient population within the auto toxicity prevention application. Now that the NCCN AYA guidelines have been modified, we've submitted PEDMARC data packages to the remaining targeted clinical drug compendia and anticipate that these updates to the compendia will be completed by the end of this quarter. So, with all these recent milestones achieved, we remain optimistic and excited about the second half of the year for Fennec, given the foundation that we put in place during the first 18 months of the launch.

Speaker Change: We believe this allows pet mark to access a broader patient population within the auto toxicity prevention application.

Speaker Change: Now, let's see now that the CCN AIE guidelines have been modified we've submitted petsmart data packages to the remaining targeted clinical drug compendium and anticipate that these updates to the companion will be completed by the end of this quarter.

Speaker Change: So with all these recent milestones achieved we remain optimistic and excited about the second half of the year for fenech, given the foundation that we've put into place to FERC.

Speaker Change: First 18 months of the launch we're confidence and are confident in our ability to navigate through these market place changes and to achieve long term objectives. Our outlook for the next few quarters were largely depend on our ability to continue to make positive steps forward with these key institutions and successfully target community Haas.

Jeffery Hackman: We're confident in our ability to navigate through these market changes and to achieve long-term objectives. Our outlook for the next few quarters will largely depend on our ability to continue to make positive steps forward with these key institutions and successfully target community hospitals and infusion centers to treat in the outpatient setting with these older patients, within our label and the NCCN guidelines for adolescents and young adults. Our plans to do so include: Our sales force has expanded its activities and is now into the community centers that treat this AYA population that fall within our label.

Jeff Hackman: We're confident in our ability to navigate through these market changes and to achieve long-term objectives. Our outlook for the next few quarters will largely depend on our ability to continue to make positive steps forward with these key institutions and successfully target community hospitals and infusion centers to treat in the outpatient setting with these older patients, within our label and the NCCN guidelines for adolescents and young adults. Our plans to do so include: Our sales force has expanded its activities and is now into the community centers that treat this AYA population that fall within our label.

Speaker Change: Spittle in infusion centers to treat the outpatient setting with these older patients.

Speaker Change: Within our label and the NCC and guidelines for adolescents and young adults.

Speaker Change: Our plans to do so include our.

Speaker Change: Our sales force has expanded their activities and now are in the community centers that treat this a way a population that fall within our label. We believe that there are significantly more patients in this segment compared to the inpatient hospital treated pediatric population reach.

Jeffery Hackman: We believe that there are significantly more patients in this segment compared to the inpatient hospital-treated pediatric population. Recently, we have administered to patients within this population, including tumor types such as testicular cancer, ovarian cancer, and head and neck cancer. We have successfully managed the reimbursement process with major health plans, such as Blue Cross Blue Shield, United, and Caremark. We continue to work diligently with senior managers to extend our reach into infusion center hours to accommodate the time that it takes to administer PETBARC, which is six hours after splat and infusion.

Jeff Hackman: We believe that there are significantly more patients in this segment compared to the inpatient hospital-treated pediatric population. Recently, we have administered to patients within this population, including tumor types such as testicular cancer, ovarian cancer, and head and neck. We have successfully managed the reimbursement process with major health plans, such as Blue Cross Blue Shield, United, and Caremark. We continue to work diligently with senior managers to extend our reach into infusion center hours to accommodate the time that it takes to administer pet bark, which is six hours after splat and infusion.

Speaker Change: <unk>, we have administered to patients within this population, including tumor types, such as testicular cancer ovarian cancer and head and neck cancer.

Speaker Change: We have successfully manage the reimbursement process with major health plans, such as Blue Cross Blue Shield, United and Caremark.

Speaker Change: We continue to work diligently with senior managers to extend.

Speaker Change: Our reach into infusion center hours to accommodate the time that it takes to administer pet park, which is six hours. After cisplatin infusion. We will continue to build off our recent success in partnering with Orsini specialty pharmacy to help patients access petsmart through or seeing these high touch care model.

Jeffery Hackman: We will continue to build off our recent success in partnering with Orsini Specialty Pharmacy to help patients access PEDMARC through Orsini's high-touch care model, these high-touch care model centers that provide personalized patient care. Now, regarding our partnership with Norgene to commercialize Pedmarxie in Europe, Australia, and New Zealand, efforts continue to progress these territories and our targeted launch late Q4 2024, and this remains As a reminder, under the terms of the licensing agreement, Fennec received approximately $43.2 million in upfront consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestones, and tiered royalties on the net sales of Pedmarxie in these licensed territories up to the mid-twenties. Naurjean will be responsible for all commercialization activities in these licensed territories and will hold all marketing authorizations in these licensed territories.

Jeff Hackman: We will continue to build off our recent success in partnering with Orsini Specialty Pharmacy to help patients access PEDMARC through Orsini's high-touch care model, these high-touch care model centers that provide personalized patient care. Now, regarding our partnership with Norgene to commercialize PEDMARCSI in Europe, Australia, and New Zealand, efforts continue to progress these territories and our targeted launch late Q4 2024, and this remains on track As a reminder, under the terms of the licensing agreement, Fennec received approximately $43.2 million in upfront consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestones, and tiered royalties on the net sales of Pedmarxie in these licensed territories up to the mid-twenties.

Speaker Change: These high touch care model centers that provide personalized patient care.

Speaker Change: Now regarding our partnership with <unk> to commercialize paid marketing in Europe, Australia, and New Zealand efforts continued to progress these territories and our targeted launch late Q4 2024, and this remains on track as a reminder, under the terms of the licensing agreement fenech received them.

Proximately $43 2 million in upfront consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestone payments and tiered royalties on net sales of <unk> in these license territories up too.

Speaker Change: The mid twenties.

Robert Andrade: Noorjean will be responsible for all commercialization activities in these licensed territories and will hold all marketing authorizations in these, The next major milestone will be evaluated after the launch of Germany in Q4 2024. As we previously communicated, this partnership represents an important step for achieving our mission, of expanding PEDMARCSI to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity, these terms provided, us with many important benefits, including an upfront payment, further solidifying our balance sheet, attractive economic terms, providing a meaningful meaningful participation in the ex-U.S. success of PEDMAR, and an experienced partner to successfully launch PEDMARC-C in these licensed territories.

Speaker Change: <unk> will be responsible for all commercialization activities in these license territories and will hold all marketing authorizations in these license territories.

Jeffery Hackman: The next major milestone will be evaluated after the launch of PEDMARCSI in Germany in Q4 2024. As we previously communicated, this partnership represents an important step for achieving our mission of expanding PEDMARCSI to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity. These terms provided us with many important benefits, including an upfront payment, further solidifying our balance sheet, attractive economic terms, providing a meaningful meaningful participation in the ex-U.S. success of PEDMARC, and an experienced partner to successfully launch PEDMARC-C in these licensed territories.

Speaker Change: Next major milestone will be evaluated after the launch of Germany in Q4 2024.

Speaker Change: As we previously communicated this partnership represents an important step for achieving our mission of.

Speaker Change: Of expanding <unk> to patients across the globe, who are at risk of suffering from cisplatin induced OTO toxicity.

Speaker Change: These terms provided.

Speaker Change: US with many important benefits, including an upfront payment further solidifying our balance sheet attractive economic terms, providing a meaningful meaningful participation in the ex U S success of <unk>.

Speaker Change: And experience and an experienced partner to successfully launched <unk> in these license territories.

Jeffery Hackman: So in closing, we continue to see promising opportunities for PEDMARC, including the steps we're taking to educate the marketplace along with executing on our commercial plan. We are looking forward to seeing the benefits of our actions in the coming months. With that, I'm gonna turn the call back over to Robert to go over the financials for the quarter. Thank you.

Robert Andrade: So in closing, we continue to see promising opportunities for PEDMARC, including the steps we're taking to educate the marketplace, along with executing on our commercial plan. We are looking forward to seeing the benefits of our actions in the coming months. With that, I'm going to turn the call back over to Robert to go over the financials for the court. Thank you, Jeff.

Speaker Change: So in closing we continue to see promising opportunities for <unk>, including the steps, we're taking to educate the marketplace along with executing on our commercial plans.

Speaker Change: We are looking forward to seeing the benefits of our actions in the coming months.

Speaker Change: So with that I'm going to turn the call back over to Robert to go over the financials for the quarter.

Robert Andrade: Thank you, Jeff. Our press release contains details of our financial results for the second quarter of 2024, which can also be viewed in the Investors and Media section of our website. Rather than read through all of those details, my comments today will focus on some key financial results. As stated, the company recorded PEDMARC net sales of $7.3 million for the second quarter of 2024. This represents an increase of approximately 120% compared to the same quarter in 2023. GNA for the second quarter of 2024 was 6.9 million, which compares to 5.5 million in the comparable quarter of 2023 and 5.8 million in the first quarter of 2024.

Robert Andrade: Our press release contains details of our financial results for the second quarter of 2024, which can also be viewed in the investors and media section of our website. Rather than go through all of those details, my comments today will focus on some key financial resources. As stated, the company recorded PEDMARC net sales of $7.3 million for the second quarter of 2024. This represents an increase of approximately 120% compared to the same quarter in 2020. GNA for the second quarter of 2024 was $6.9 million, which compares to $5.5 million in the comparable quarter of 2023 and $5.8 million in the first quarter of 2025.

Robert: Thank you Jeff Our press release contains details of our financial results for the second quarter of 2024.

Speaker Change: Which can also be viewed on the investors and media section of our website.

Robert Andrade: This increase is largely attributable to the pre-commercialization efforts for potential European launches or partnerships that we were exploring, and expenses associated with the NORGENE transaction. As discussed on previous calls, we anticipate all major EU-related expenses to wind down in the second quarter of 2024. Selling and marketing expenses include remuneration for our sales and marketing employees, dollars for marketing campaigns, such as sponsorships, trade shows, and presentations, and any activities to support marketing and sales.

Robert: Rather than read through all of those details my comments today will focus on some key financial results.

Robert: As stated the company recorded pet Mark net sales of $7 3 million for the second quarter of 2024.

Robert: This represents an increase of approximately 120% compared to the same quarter in 2023.

Robert: G&A for the second quarter of 2024 was $6 9 million, which compares to $5 5 million in the comparable quarter of 2023, and $5 8 million in the first quarter of 2024.

Robert Andrade: This increase is largely attributable to the pre-commercialization efforts for potential European launches or partnership that we were exploring, and expenses associated with the NORGENE transaction. As discussed on previous calls, we anticipate all major EU-related expenses to wind down in the second quarter of 2024. Selling and marketing expenses include remuneration of our sales and marketing employees, and dollars spent on marketing campaigns, such as sponsorships, trade shows, and presentations.

Robert: This increase is largely attributable to the pre commercialization efforts for potential European launch or partnership that we're exploring.

Robert Andrade: And any activities to support marketing and sales. The company reported $4.6 million in selling and marketing expenses in the second quarter of 2024, compared to $2.4 million in the comparable quarter and $5.8 million in the first quarter of 2020. The increase was largely attributable to higher payroll and increased market expenses related to the previously mentioned AYA. And finally, to our cast positions. We ended the first quarter with approximately $43 million in cash and cash equivalents. The decrease in cash over the first quarter of 2024 was as a result of cash expenses related to sales and marketing and GNA, as described earlier, along with EU-related expenses, including those associated with the Norgene transaction.

Robert: And expenses associated with the <unk> transaction.

As discussed on previous calls, we anticipate all major EU related expenses to wind down in the second quarter of 2024.

Speaker Change: Selling and marketing expenses include a renewed variation of our sales and marketing employees dollars on marketing campaigns, such as sponsorships tradeshows and presentations and any activities to support marketing and sales.

Robert Andrade: The company reported $4.6 million in selling and marketing expenses in the second quarter of 2024, compared to $2.4 million in the comparable quarter and $5.8 million in the first quarter of 2024. The increase was largely attributable to higher payroll and increased market expenses related to the previously mentioned AYA initiatives, and finally, to our cast position.

Robert: The company reported $4 6 million in selling and marketing expenses in the second quarter of 2024 compared to $2 $4 million in the comparable quarter.

Robert: And $5 8 million in the first quarter of 2024.

Robert: The increase was largely attributable to higher payroll and increased marketing expenses related to the previously mentioned <unk> way initiatives.

Robert: And finally to our cash position.

Robert Andrade: We ended the first quarter with approximately $43 million in cash and cash equivalents. The decrease in cash over the first quarter of 2024 was as a result of cash expenses related to sales and marketing and G&A, as described earlier, along with EU-related expenses, including those associated with the Norgene transaction. Furthermore, as a reminder, the next milestone related to our Norwegian agreement will be obtaining pricing approval in Germany, where Fennec will have the opportunity to receive a 10 million euro milestone.

Robert: We ended the first quarter with approximately $43 million in cash and cash equivalents.

Robert: The decrease in cash over the first quarter of 2024.

Robert: As a result of cash expenses related to sales and marketing and G&A described earlier, along with EU related expenses, including those associated with the <unk> transaction.

Robert Andrade: Further, as a reminder, the next milestone related to our NORGENE agreement will be obtaining pricing approval in Germany, where Fennec will have the opportunity to receive a 10 million euro milestone. Additionally, Fennec's royalties on net sales are anticipated to commence in the mid-teens upon launch in Q4 of 2020. With that, we anticipate that our cash and cash equivalents as of June 30, 2024, when coupled with PEDMARC revenue assumptions and the recently announced licensing agreement for Europe with Norgene, will be sufficient to fund our planned operations for at least the next 12 months. And lastly, I would like to thank investors for their support as we take the necessary steps to regain market confidence. We successfully sold the EU rights to Norgene in March 2020.

Robert: Further as a reminder, the next milestone related to our door gene agreement will be obtaining pricing approval in Germany.

Robert: And which fenech will have the opportunity to receive a $10 million euro milestone.

Robert Andrade: Additionally, Fennec's royalties on net sales are anticipated to commence in the mid-teens upon launch in Q4 of 2024. With that, we anticipate that our cash and cash equivalents, as of June 30th, 2024, when coupled with PEDMARC revenue assumptions in the recently announced licensing agreement for Europe with Norgean, will be sufficient to fund our planned operations for at least the next 12 months. And lastly, I would like to thank investors for their support as we take the necessary steps to regain market confidence.

Robert: Additionally, Fedex royalties on net sales are anticipated to commence in the mid teens upon launch in Q4 of 2024.

Robert: With that we anticipate that our cash and cash equivalents as.

Robert: As of June 32024, when coupled with <unk> revenue assumptions and the recently announced licensing agreement for Europe, and <unk> will be sufficient to fund our planned operations for at least the next 12 months.

Robert: And lastly, I would like to thank the investors for their support as we take the necessary steps to regain market confidence.

Robert Andrade: We successfully sold the EU rights to Norgene in March 2024, and we are currently seeing signs that the AYA channel is open. And we look forward to sharing the next chapter of Fennec and the introduction of Jeff and his expertise in the coming weeks through various conferences and investor discussions, including Wedbush this week and H.C. Weinreich and Cantor in September of 2024, and Operator. With that, we are ready for questions. Thank you, ladies and gentlemen. If you have a question...

Robert: We successfully sold the EU rights to <unk> in March 2024.

Operator: We are currently seeing signs that the AYA channel is open, and we look forward to sharing the next chapter of Fennec and the introduction of Jeff and his expertise in the coming weeks through various conferences and investor discussions, including Wedbush this week, and H.C. Weinreich and Cantor in September of 2024, and Operator. With that, we are ready for questions. Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 1-1 again.

Robert: We are currently seeing signs that the channel is open.

Jeff Hoffman: And we look forward to sharing the next chapter of Phenix and the introduction of Jeff and his expertise in the coming weeks through various conferences and investor discussions, including Wedbush. This week and HC Wainwright at Cantor in September of 2024.

Speaker Change: And operator with that we're ready for questions.

Operator: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 1-1 again. We will pause for a moment while we compile our Q&A list. Our first question comes from Chase Knickerbocker with Craig Hallam. Your line is open.

Speaker Change: Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered your question with yourself from the queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.

Operator: We will pause for a moment while we compile our Q&A roster. Our first question comes from Chase Knickerbocker, with Craig Hallam, your line is open. Good morning, thanks for taking the questions and Jeff, congrats on the new role. Maybe on that note... Maybe you could speak to Jeff, maybe you could speak a little bit more as to what you saw here at Fennec that really got you excited to join the team.

Speaker Change: Our first question comes from Jason Knickerbocker with Craig Hallum. Your line is open.

Chase Knickerbocker: Good morning, thanks for taking the questions and Jeff, congrats on the new role. Um, maybe on that note... Maybe you speak to Jeff, maybe you speak a little bit more as to what you saw here at Fennec that really got you excited to join the team, and then even more so, kind of, what opportunities you saw, you know, with your skill set and experiences to come in here and kind of quickly create shareholder value, kind of institute, you know, maybe some things that you had at previous companies around kind of commercial execution, commercial excellence, et cetera, that you think you can kind of create shareholder value with here at Fennec.

Jason Knickerbocker: Good morning, Thanks for taking the questions and Jeff Congrats on the neuro.

Speaker Change: Maybe on that note.

Jeff Hackman: And then even more so, kind of, what opportunities you saw, you know, with your skill set and experience to come in here and kind of quickly create shareholder value, kind of institute, you know, maybe some things that you had at previous companies around kind of commercial execution, commercial excellence, etc. that you think you can kind of create shareholder value with here at Fennec. Yeah, you know, I, I, it's day seven.

Jason Knickerbocker: Maybe just speak to Jeff, maybe just speak a little bit more as to what you saw here that really got you excited to join the team and then even more so kind of what opportunities you saw.

Speaker Change: With your skill set and experiences to come in here and kind of quickly create shareholder value kind of Institute.

Speaker Change: Some things that you had at previous companies around kind of commercial execution commercial excellence et cetera that you think you can kind of create shareholder values here at fennec.

Jeffery Hackman: Yeah, you know, it's day seven. So I'm excited to be, you know, to be on the call today. And I have seen some things, and in my preparation to come here, I was excited to lead Fennec in this role because I did see a significant opportunity here. There's talent, you know; there is leadership experience that I've seen. And it's a great jumping point and a great start for me.

Jeff Hackman: So I'm excited to be, you know, on the call today. And I have seen some things, and in my preparation to come here, I was excited to lead Fennec in this role because I did see a significant opportunity. There's talent, there's leadership experience that I've seen. And it's a great jumping point and a great start for me.

Speaker Change: Yes.

Speaker Change: No.

Speaker Change: Thanks, Kevin So I'm excited to.

Speaker Change: B.

Speaker Change: To be on the call today, and I have seen some things and I did in my preparation to come here.

Speaker Change: It was.

Speaker Change: I was excited to lead.

Speaker Change: <unk> in this world because I did see a significant opportunity here.

Speaker Change: There is talent.

Speaker Change:

Speaker Change: There is leadership.

Speaker Change: <unk> experience that I've seen.

Speaker Change: And it's a great jumping.

Speaker Change: Jumping point in great start for me.

Jeffery Hackman: I've got the experience, Chase, to understand where the opportunities are, and I'm excited to bring that here. I have experience in these markets. I've got experience not only in pediatric COG institutions but also moving a product from pediatrics into the AYA space. Right now, I'm identifying gaps, and I'm looking to see where I can have some quick wins and move the company forward. So I'm looking forward to talking more about my experiences and what I'm going to be

Jeff Hackman: I've got the experience, Chase, to understand where the opportunities are, and I'm excited to bring that. I have experience in these markets. I have experience, not only in pediatric COG institutions but also moving a product from pediatrics into the AYA space.

Speaker Change: Got the experience chase too.

Speaker Change: To understand where the opportunities are and I am excited to bring that here.

Speaker Change: I have got experience in these markets.

Speaker Change: Got experience not only in the pediatric <unk>.

Speaker Change: <unk>, but also moving a product from PDL.

Speaker Change: Pediatric into the <unk> space.

Speaker Change: So.

Jeff Hackman: Right now, I'm identifying gaps, and I'm looking to see where I can, have some quick wins, and move the company forward. So I'm looking forward to talking more about my experiences and what I'm doing.

Speaker Change: Right now I'm identifying gaps and I'm looking to see where I can.

Speaker Change: I have some quick wins and move the company forward. So I'm looking forward to talking more about my experiences in what I'm going to be planning here.

Jeff Hackman: And then, you know, we spoke to AYA Progress kind of in the press release and also kind of briefly on the call. Can you just maybe give us a little bit more of a window into what we're seeing so far, you know, through July and into August? I mean, have we seen, you know, quite a few physicians adopt?

Chase Knickerbocker: Great. And then, you know, we spoke to AYA Progress kind of in the press release and also kind of briefly on the call. Can you just maybe give us a little bit more of a window into what we're seeing so far, you know, through July and into August? I mean, have we seen, you know, quite a few physicians adopt? Try a couple patients?

Great and then you always spoke to progress kind of in the press release and also kind of briefly on the call can you just maybe give us a little bit more of a window into what we're seeing so far through July and into August.

Robert Andrade: Have we seen some more high volume adopters? I mean, how should we think about the progress thus far? And was that largely unlocked, you know, from the NCCN guideline wording change? And then kind of what are the gating factors still there in AYA that kind of need to be addressed? You mentioned the compendium.

Speaker Change: We've seen.

Speaker Change: Quite a few physicians adopt try a couple of patients have we've seen some more high volume of doctors.

Chase Knickerbocker: Have we seen some more high-volume adopters? I mean, how should we think about the progress thus far? And was that largely unlocked, you know, from the NCCN guideline wording change? And then kind of what are the gating factors still there in AYA that kind of need to be addressed? You mentioned the compendium. Just kind of speak to how you kind of see Q3 kind of developing from the AYA side.

Speaker Change: Should we think about the progress thus far in but that largely unlocked.

Speaker Change: Man CCN guideline kind of wording change and then kind of what are the gating factor is still there and that kind of need to be addressed you mentioned that companion just kind of speak to how you kind of see Q3 kind of developing from the OE side.

Robert Andrade: Just kind of speak to how you kind of see Q3 kind of developing from the AYA side. Thanks, Chase. It's Robert.

Robert Andrade: Thanks, Chase. It's Robert.

Robert Andrade: I'll take the bulk of that question. As you know, we've laid quite a bit of foundation work in the last several quarters in preparing for and hopefully manifesting this AYA opportunity. Part of that work included the updating of the NCCN guidelines, which we were pleased with and successful in.

Speaker Change: Sure.

Speaker Change: Yes, Thanks, Jay it's Robert.

Speaker Change: Ill take the bulk of that question.

Robert: As you know, we've we've made quite a bit of foundation work for the last several quarters.

Robert Andrade: I'll take the bulk of that question. As you know, we've laid quite a bit of foundation work in the last several quarters in preparing for and, hopefully, manifesting this AYA opportunity. Part of that work included the updating of the NCCN guidelines, which we were pleased with and successful in. But I think really early on in this quarter, what we're seeing are institutions becoming more aware of PEDMARC, and that's really a credit to our commercial team.

Robert: In preparing for and hopefully manifesting this AIA opportunity.

Robert: Part of that work included.

Speaker Change: The updating of the NCC guidelines, which we were pleased with the successful with.

Robert Andrade: But I think really early on in this quarter, what we're seeing are institutions becoming more aware of Pennmark, and that's really a credit to our commercial team. As they become more aware, and get reimbursed, we start to see some follow-up. And we're pleased with that again in July and going into August. And it's just, you know, it's really just the tip, but that's starting to come through. And I think that's hopefully what is being communicated. And is it also being successful in getting the clinics to stay open later? Are we treating these patients? Are we infusing them in the home setting?

Speaker Change: But I think really early on in this quarter, what we're seeing are institutions, becoming more aware.

Speaker Change: <unk>, Mark and Thats it.

Speaker Change: That's really a credit to our commercial team.

Robert Andrade: As they become more aware and get reimbursed, we start to see some follow-up. And we're pleased with that, again, in July and going into August. It's just, you know, it's really just the tip. But that's starting to come through, and I think that's hopefully what is being communicated.

Speaker Change: As they become more aware.

Speaker Change: And they get reimbursed.

Operator: Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' second quarter of 2024 earnings and corporate update conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session in the structural and how to participate and we'll be given at that time. As a reminder, today's conference call is being recorded.

Speaker Change: We start to see some follow through.

Speaker Change: And we're pleased with that again in July and going into August and it's just it's really just the tip.

Speaker Change: But that's starting to come through and I think that's hopefully what is being messaged.

Robert Andrade: Now, I'd like to turn the comments over to Fennec's chief financial officer, Robert Andrade. Please go ahead. Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec's pharmaceuticals' second quarter of 2024 earnings conference call, during which we will review our financial results, as well as provide a general business update.

Speaker Change: Talk to you.

Chase Knickerbocker: And is it also being successful in getting the clinics to stay open later? Are we treating these patients? Are we infusing them in the home setting?

Speaker Change: And is it also being successful in getting the clinics to stay open later are we treating these patients are infusing them in the home setting I mean, just kind of walk through maybe that logistical challenge and how thats kind of played out.

Robert Andrade: I mean, just kind of walk through that logistical challenge and how that's kind of played out. Yeah, it's a good question. It's a combination of both. What we also alluded to in our script, in our commentary, was the Orsini partnership that we have, which we've started to see some traction on. And that includes either bringing a home nurse to the patient or bringing them through in a white bag to the actual oncologist.

Chase Knickerbocker: I mean, just kind of walk through that logistical challenge and how that's kind of played out.

Robert Andrade: Yeah, it's a good question. It's a combination of both.

Speaker Change: Yes, it's a good question, it's a combination of both.

Robert Andrade: What we also alluded to in our script and our commentary was the Orsini partnership that we have, which we've started to see some traction on. And that includes either bringing a home nurse to the patient or bringing it through in a white bag to the actual oncologist. And important with that is also reimbursement, and so I think we have identified a few large payers that have reimbursed. And so that's again quite a bit of progress over the last quarter.

Speaker Change: What we also even alluded to in our script and our commentary was the <unk> partnership that we have.

Robert Andrade: Joining me from Fennec this morning is our newly appointed chief executive officer and board member, Jeff Hackman. Jeff joined Fennec on August 5th and brings more than 30 years of commercial leadership, including oversight of more than 10 product launches across a wide range of therapeutic areas and markets. Importantly, Jeff has successfully commercialized products that are specifically relevant to the PED Mark markets.

Speaker Change: Which we've started to see some traction there and that includes either bringing a home nurse.

To the patient or bringing it through a white bag to the actual oncologist.

Robert Andrade: And important with that is also reimbursement, and so I think we have identified a few large payers that have reimbursed. And then lastly, to your question in terms of clinics, we have, depending on the clinic, been able to get them to keep their hours open, et cetera. But I think it's really a combination of both, and we anticipate that going forward. Got it, and then just maybe, you know, how has the pediatric business done, how did it kind of play out in Q2? You know, I think it was kind of down; it was obviously going down modestly, sequentially.

Speaker Change: An important with that is also the reimbursement and so I think we we signaled a few large payers that have reimbursed.

Robert Andrade: Now, before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S., securities, and exchange commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements.

Speaker Change: And so thats again quite quite a quite a bit of progress over the last quarter.

Robert Andrade: And then lastly, to your question in terms of clinics, we have, depending on the clinic, been able to get them to keep their hours open, et cetera. But I think it's really a combination of both, and we anticipate that going forward.

Speaker Change: And then lastly to your to your question in terms of clinics, we have depending on the clinic.

Speaker Change: <unk> been able to get them to keep their hours open et cetera, but I think it's really a combination of both and we anticipate that going forward.

Chase Knickerbocker: Got it. And then maybe, you know, how has the pediatric business, how did you, how did it kind of play out in Q2? You know, I think it was kind of down; it was obviously down modestly, sequentially. Do you think that that business has kind of found its footing now? And, you know, do you expect it to kind of be the bottom there or kind of walk through how we should think about the pediatric business from here?

Speaker Change: Got it and then just maybe.

Speaker Change: How is the pediatric business how did you how did it play out in Q2, and I think it was kind of down. It was obviously down modestly sequentially do you think that that business has kind of found its footing now.

Robert Andrade: Do you think that that business has kind of found its footing now and, you know, you expect it to kind of be at the bottom there or kind of walk through how we should think about the pediatric business from here? Yeah, I'll take that as well to start, and I think maybe Jeff can add some of the experience on the pediatric side. But, as you know, this is a very small population.

Speaker Change: You expect us to kind of be the bottom there or kind of walk through how we should think about the pediatric business.

Operator: This conference call is being recorded for audio re-broadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days.

Speaker Change: From here.

Robert Andrade: Yeah, I'll take that as well to start, and I think maybe Jeff can add some of his experience on the pediatric side. But, as you know, this is a very small population. We have a great base of business there in terms of some centers and some hospitals and some KOLs that really understand the product and the benefits. Do we think there's an opportunity to continue to grow? Yes, but again, we really do have that stable base with us.

Speaker Change: Yes, I'll take that as well starting I think maybe Jeff can add some of his experience on the pediatric side.

Jeff Hackman: And now it gives me pleasure to turn the call over to Jeff Hackman. Thank you, Robert. And good morning, everyone.

Speaker Change: But as you know this is a very small population.

Robert Andrade: We have a great base of business there in terms of some centers and some hospitals and some KOLs that really understand the product and the benefits. Do we think there's an opportunity to continue to grow yet? Yes, but again, we really have that stable base with us.

Speaker Change: Have some a great base of business there in terms of some centers and some hospitals and some kols.

Jeff Hackman: I'm incredibly excited to lead Fennec in this new role. And I look forward to working with this team to direct the organization through its continued growth efforts.

Speaker Change: They really understand the product and the benefits.

Speaker Change: Do we think there is an opportunity to continue to grow yes.

Robert Andrade: There's ebbs and flows in every quarter, and I think part of what Jeff's doing here and what he's going to bring in here is bringing in a two-pronged focus so that we continue to make traction on that AYA while, at the same time, also evaluating that opportunity within traditional pediatrics. Yeah, I think there's an opportunity still there, Chase, so we'll continue to look at the levers that we need to pull and what the execution has been and what it should be going forward with these PDFs.

Jeff Hackman: Before I introduce myself, I would like to thank Ross D for his dedication and leadership since 2009. He's been critical not only to the success of Fennec, but bringing a much needed therapy to the pediatric oncology population. That was at risk for irreversible hearing loss, which can be a profound lifelong impact, as you know, on these patients. On behalf of everyone at Fennec, we're pleased we will be able to continue to benefit from Ross's experience and knowledge as we enter into the next chapter.

Speaker Change: But again, we're really havent have that stable base with us there.

Robert Andrade: There's ebbs and flows in every quarter, and I think part of what Jeff's doing here and what he's gonna bring in here is bringing in a two-pronged focus so that we continue to make traction on that AYA while, at the same time, also evaluating that opportunity within the traditional pediatric. Yeah, I think there's an opportunity.

Speaker Change: There's ebbs and flows in every quarter.

Speaker Change: Part of what Jeff is doing here and what he's going to bring in here is bringing in a two pronged focus so that we continue to make traction on that AIA, while at the same time also.

Speaker Change: Evaluate that opportunity within the traditional pediatric yes, I think theres an opportunity still there today so.

Jeffery Hackman: Yeah, I think there's an opportunity still there, Chase, so we'll continue to look at the levers that we need to pull and what the execution has been and what it should be going forward with these pediatric institutions. So it's something I'm evaluating.

We will continue to look at.

Speaker Change: The levers that we need to pull.

Speaker Change: And what the execution has been and what it should be going forward with these pediatric institutions. So it's something I'm evaluating.

Jeff Hackman: Let me talk a little bit about me. My tenure in oncology spans the last 12 years or so with companies like SigmaTow, BackSaltis, Shire, and Yusufarma, where I was responsible for the U.S, commercial organizations and managing the company's product portfolios in multiple franchises, generating billions and revenues over those years. As Robert mentioned, I have specific experience commercializing oncology products that are specifically relevant to PED Mark Mark, and in the pediatric oncology community where I spent a lot of time and I'm passionate about.

Robert Andrade: So it's something I've been working on for a long time. Got it. And just last for me, guys, I'm sorry for all the questions, but just with kind of the combination of those two starting to see progress in AYA and, you know, pediatric, you know, seeming, you know, to be a stable, you know, a stable business, kind of put your commentary there and, you know, kind of potentially, you know, trying to return that to growth, obviously, would you expect this, the business as a whole with those two, you know, parts to start to grow meaningfully sequentially again, and then again, I'll hop back in the queue, but grow meaningfully sequentially again from here. That's what I mean.

Chase Knickerbocker: Got it. And just last for me, guys, I'm sorry for all the questions, but just with kind of the combination of those two starting to see progress in AYA and, you know, pediatric, you know, seeming, you know, to be a stable, you know, a stable business, kind of put your commentary there and, you know, kind of potentially, you know, trying to return that to growth, obviously, would you expect this, the business as a whole with those two, you know, parts to start to grow meaningfully sequentially again, and then again, I'll hop back in the queue, but grow meaningfully sequentially again from here.

Speaker Change: Got it and then just last from me guys I'm, sorry for all the questions.

Speaker Change: But just with kind of the combination of those two starting to see progress in AIA.

Speaker Change: And pediatric.

Speaker Change: Assuming stable.

Speaker Change: Our stable business kind of put your commentary there and kind of potentially trying to return that to growth obviously.

Speaker Change: What do you expect this business as a whole with those two parts to start to grow meaningfully sequentially again, and then again I'll hop back in the queue, but grow meaningfully sequentially again from here.

Speaker Change: Thanks.

Robert Andrade: I'll start with it. Jeff's on day seven. We are here to grow meaningfully. Jeff's here to grow us meaningfully and to help us grow meaningfully. So that's always our goal, if that wasn't the case. So that's our plan.

Robert Andrade: Thanks. I'll start with it. Jeff's on day seven.

Speaker Change: I'll start with that.

Jeff Hackman: From my very first early interactions with the team here at Fennec through my last week here, it's clear to me that we have access to an incredible pool of talent at Fennec. Fennec's dedication, expertise, and passion are evident and I'm confident that together we can work to fill any gaps and address any needs to drive our organization forward.

Speaker Change: I mean, Jeff Sundays seven.

Speaker Change: We are here to grow meaningfully just here to grow as meaningfully as to help us grow meaningfully so.

Speaker Change: That's always our goal.

Speaker Change: I wouldn't have gone yes.

Speaker Change: If that wasn't the case, so thats our plan.

Robert Andrade: We are here to grow meaningfully. Jeff's here to grow us meaningfully and to help us grow meaningfully. So that's always our goal, if that wasn't the case. So that's our plan. Thank you, guys.

Speaker Change: Thanks, guys.

Jeffery Hackman: Yeah, I appreciate your question. One moment.

Operator: Yeah, I appreciate your question. One moment for our next question. Our next question comes from Naureen Quibria with Capital One Securities. Your line is open. Hi, good morning.

Operator: One moment for our next question. Our next question comes from Naureen Quibria with Capital One Securities. Your line is open.

Speaker Change: Yes, I appreciate your questions one of them one of them are for our next question.

Jeff Hackman: Now turning to our second quarter, 2024 financial results, all of which were outlined in our earnings press release issues earlier this morning before the call. We will also discuss ongoing commercial launch efforts and the progress we're making with PED Mark in the US and abroad following exclusive licensing agreement announcement. We executed in March with Norgine to commercialize PED Mark C in Europe, Australia, and New Zealand. In the second quarter, PED Mark delivered net revenues of 7.3 million.

Speaker Change: Yes.

Irene <unk>: Our next question comes from Irene <unk> with capital One Securities. Your line is open.

Naureen Quibria: Hi, good morning. And yeah, Jeff, congratulations on the new role. Rosti will be missed. So I guess my first question, sort of following up on one of Chase's questions, which is about the AYA opportunity. I believe on the last call, you know, there were plans to conduct pilot studies in the community setting. Could you sort of comment on what was happening there or the progress there?

Operator: And yeah, Jeff, congratulations on the new role; Rosti will be missed. So I guess my first question sort of follows up on one of Chase's questions, which is about the AYA opportunity. I believe on the last call, you know, there were plans to conduct pilot studies in the community setting. Could you sort of comment on what was happening there?

Irene: Hi, good morning.

Irene: Yes, Jeff congratulations on a neural.

Irene <unk>: So I guess my first question sort of following up on one of total questions Richard.

Irene: On the.

Speaker Change: Hey, my opportunity I believe on the last call there were plans to conduct pilot studies in the community setting.

Speaker Change: Would you sort of comment on what.

Speaker Change: What's happening there.

Speaker Change: Progress there.

Robert Andrade: Thank you for the question and your always interest. Yes, you're correct.

Robert Andrade: Or the progress there? Yeah, Naureen, thank you for the question and always your interest. Yes, you're correct.

Jeff Hackman: We believe there were several key milestones that achieved that we achieved recently that will enable us to accelerate patient access and build off the second quarter. In May, the office of New Drugs at the FDA added a safety communication issued by Cedar professional affairs and stakeholder engagement staff to PED Mark's approval on the FDA page. Now it is clear that substitutions pose potential health risks. Phenics continues to diligently work with the FDA to address this issue.

Speaker Change: Alright. Thank you for the question I would always be interest, yes, youre correct.

Robert Andrade: We've been able to make progress and traction, and that goes to our commentary, with some of these new institutions. And the good news is that we are seeing reimbursement from these institutions. And that eventually will come with follow through. So the answer to your question is, yes, we've had success there, and we hope to continue to build on that here in Q3 and beyond. Got it. And then can you just sort of comment a bit more on the compounding issue? I mean, how prevalent is it now still?

Speaker Change: Been able to make progress and traction in that goes to our commentary.

Speaker Change: With some of these new institutions.

Robert Andrade: We've been able to make progress and traction, and that goes to our commentary with some of these new institutions. And the good news is that we are seeing reimbursement from these institutions, and that will eventually come with follow-through. So, the answer to your question is yes, we've had success there, and we hope to continue to build on that here in Q3 and beyond.

Speaker Change: And the good news is that we are seeing reimbursement from these institutions and that eventually will come with follow through.

Speaker Change: So the answer to your question is yes, we have had success there and we hope to continue to build off of that here in Q3 and beyond.

Naureen Quibria: Got it. And then can you just sort of comment a bit more on the compounding issue? I mean, how prevalent is it now still?

Speaker Change: Okay got it and then can you just comment a bit more on the compounding issue I mean, how prevalent is it now.

Jeff Hackman: During the second quarter, notifications were sent outlining the FDA non-substitution status. Pair recipients included Medicare Administrative Contractors, Medicare Advantage, Manage Medicaid, and Commercial Pairs. Provider recipients included all state oncology societies, the top 20 health systems including children's hospitals, and more than 360 oncology practices. These are community-based or hospital-owned. Additionally, as of April 1st, RJ Code was issued, and we fully resolved this with CMS amending it to specify PED Mark. Now that this change is affected, we are seeing uptake that we believe will continue to improve the quarters as we move forward.

Robert Andrade: I mean, that's part of what we're going to evaluate on the pediatric side. We clearly know the value of PEDMARC, all the clinical studies that we've done there, and the benefit to the patient. And so is that one of the challenges within the pediatric side? Yes, but we feel with execution and the proper approach, and maybe Jeff can add a little bit to this, we can continue to grow that side of the business.

Robert Andrade: That's part of what we're going to evaluate on the pediatric side. We clearly know the value of PEDMARC, all the clinical studies that we've done there, and the benefit to the patient. And so, is that one of the challenges within the pediatric side? Yes, but we feel with execution and the proper approach, and maybe Jeff can add a little bit to this, we can continue to grow that side of the business. Yeah, I think there's, I know there's opportunity there. It's about the message, and is the message being heard? Is it being delivered?

Speaker Change: I mean, that's that's part of.

Speaker Change: What we're going to evaluate on the pediatric side, we clearly know the value of pet Mark all of the clinical studies that we've done there and the benefit to the patients.

Speaker Change: And so is that one of the challenges within the pediatric side, yet, but we feel with execution in the proper approach and maybe Jeff can add a little bit to this.

Jeff Hoffman: That we can continue to grow that side of the business as well.

Jeffery Hackman: I think there's, I know there's opportunity there. It's about the message and whether or not the message is being heard, and whether or not it's being delivered, and the execution of how it's being delivered. These are all areas where I'll be focused in my efforts here early on and quickly to understand what execution looks like there, and I look forward to sharing more once I start to kind of dive into that approach.

Jeff Hoffman: Yes.

Jeff Hoffman: I think there is I know theres opportunity there, it's about the message and the message being heard as it being delivered and the execution of how it's being delivered these are all areas, where I'll be focusing my efforts here early on and quickly to understand.

Jeff Hackman: And the execution of how it's being delivered. These are all areas where I'll be focused in my efforts here early on and quickly to understand what execution looks like there. I look forward to sharing more once I start to kind of dive in.

Jeff Hoffman: Execution it looks like there.

Jeff Hackman: Further and of great importance, the NCCN recently modified and updated their AYA guidelines for PED Mark. The guidelines removed pediatric-specific wording and allowed for patients up to 39 years of age, and two replaced cisplatin with platinum. We believe this allows PED Mark to access a broader patient population within the auto-taxicity prevention application. Now that the NCCN AYA guidelines have been modified, we've submitted PED Mark data packages to the remaining targeted clinical drug compendia, and anticipate that these updates to the compendia will be completed by the end of this quarter.

Jeff Hoffman: And.

Jeff Hoffman: I look forward to sharing more once I start to kind of dive into that approach.

Naureen Quibria: And just one more from me, are you planning to backfill the COO role now or not?

Jeff Hackman: And just one more from me, are you planning to backfill the COO role now, or not? I'm looking at where we need to put our talent and the folks that I need to potentially bring in, so I can let you know. I haven't, haven't thought that through about what positions and the gaps I need to fill just yet.

Jeff Hoffman: And just one more from me.

Speaker Change: Are you planning to backfill the CEO role now or.

Jeffery Hackman: I'm looking at where we need to put our talent and the folks that I need to potentially bring in. So I can let you know, I haven't, haven't thought that through about what positions and the gaps I need to fill just yet. I'm evaluating that my plan is I'm meeting with everybody in the organization. We're all doing one on one throughout the next week or so. And then I can assess gaps going forward and what needs to be filled. Thank you.

Speaker Change: I'm looking at.

Speaker Change: Where we need to put our.

Speaker Change: Talent and the folks that I need to potentially bring in.

So I can let you know.

Speaker Change: Haven't thought that through what positions in the gaps I need to fill just yet.

Jeff Hackman: I'm, I'm, I'm evaluating my plan. I'm meeting with everybody in the organization one on one throughout the next week or so. And, then I can assess gaps going forward and what needs to be filled and where. Thank you. That's all for me.

Speaker Change: I am evaluating that my plan is some meeting with everybody in the organization. We're all doing one on ones throughout these next week or so and and then assess gaps going forward what needs to be filled and glare.

Jeff Hackman: So, with all these recent milestones achieved, we remain optimistic and excited about the second half of the year for Fennec, given the foundation that we put into place the first 18 months of the launch. We're confident in our ability to navigate through these markets, place changes, and to achieve long-term objectives. Our outlook for the next few quarters were largely depend on our ability to continue to make positive steps forward with these key institutions, and successfully target community hospitals and infusion centers to treat the outpatient setting with these older patients within our label and the NCCN guidelines for adolescents and young adults.

Speaker Change: And we do.

Operator: Thank you, that's all from me. One moment for our next question.

Speaker Change: Thank you that's all from me.

Operator: Thanks, Lauren. One moment for our next question. Our next question comes from Raghuram Selvaraju with H.C. Rainwright. Your line is open. Hi, thanks so much for taking my questions. Can you hear me?

Brian: Thanks, Brian.

Speaker Change: One moment for our next question.

Brian: Yes.

Operator: Our next question comes from Raghuram Selvaraju, with H.C. Rainwright. Your line is open.

Speaker Change: Our next question comes from Ross Silver Archie with H C. Wainwright Your line is open.

Raghuram Selvaraju: Hi, thanks so much for taking my questions. Can you hear me?

Speaker Change: Alright. Thanks, so much for taking my questions can you hear me.

Robert Andrade: Yes, Ram. How are you?

Operator: Yes, Rahm, how are you? Very good. And Jeff, congratulations on your new role. Very exciting. So I wanted to ask about specifically the context with respect to the next milestone from Norgene and if you could maybe give us a little bit more color on how that's likely to be achieved and how you would recognize it if and when it is.

Speaker Change: Yes, Rob how are you.

Raghuram Selvaraju: Very good. Jeff, congratulations on your new role. Very exciting. So I wanted to ask about specifically the context with respect to the next milestone for Noregene and if you could maybe give us a little bit more color on how that's likely to be achieved and how you would recognize it if and when it is.

Speaker Change: Very good and Jeff Congratulations on your new role very exciting so I wanted to ask about specifically the context with respect to the next milestone from <unk> and if you could maybe give us a little bit more color on how that's likely to be earned.

Jeff Hackman: Our plans to do so include our Salesforce has expanded their activities and now are in the community centers that treat this AYA population that fall within our label. We believe that there are significantly more patients in this segment compared to the inpatient hospital treated pediatric population. Recently, we have administered to patients within this population, including tumor types such as testicular cancer, ovarian cancer, and head neck cancer. We have successfully managed the reimbursement process with major health plans, such as Blue Cross Blue Shields, United, and Care Mark.

Speaker Change: And how you would recognize it.

Pittsburgh.

Robert Andrade: Yes, as mentioned, the plan is to launch PetMarxie in Q4. The first market we will launch PEDMARC-C with Noregene will be in Germany. And the first milestone is related to achieving a certain price for the product in Germany. We are excited about that opportunity. We are optimistic about it, and so assuming we achieve that in the late Q4, early Q1 time period, then we would recognize that 10 million euros to Fennec, and we would get the cash into the company.

Robert Andrade: Yes, as mentioned, the plan is to launch PetMarxie in Q4. The first market we will launch PEDMARC-C with Norgeen will be in Germany, and the first milestone is related to achieving a certain price for the product in Germany. We are excited about that opportunity, we are optimistic about it, and so assuming we achieve that in the late Q4, early Q1 time period, then we would recognize that 10 million euros to Fennec, and we would get the cash into the company.

Speaker Change: Yes as mentioned.

Speaker Change: The plan is to launch <unk>.

Speaker Change: <unk> see in Q4.

Speaker Change: The first market, we will launch <unk> Z.

Speaker Change: With nordson will be in Germany.

Speaker Change: And the first milestone is related to achieving a certain.

For the product in Germany.

Speaker Change: We are excited about that opportunity.

Jeff Hackman: We continue to work diligently with senior managers to extend our reach into infusion center hours to accommodate the time that it takes to administer PED Mark, which is six hours after slot and infusion. We will continue to build up our recent success in partnering with Orcini specialty pharmacy to help patients access PED Mark through Orcini's high-touch care model, the high-touch care model centers that provide personalized patient care.

Speaker Change: We are optimistic about it and so assuming we achieve that.

Speaker Change: In the Q by late Q4 early Q1 time period, then we would recognize that $10 million.

Speaker Change: Euros, two fenech and we'd get the cash into the company and then secondly, you didn't specifically ask this but there is.

Robert Andrade: And then secondly, you didn't specifically ask this, but there is also a net royalty on net sales to Fennec, and that will start in the mid-teens and grow as the revenues grow to certain thresholds, or in other words, grow into higher percentages from the mid-teens.

Robert Andrade: And then secondly, you didn't specifically ask this, but there is also a net royalty, our royalty on net sales, to Fennec. And that will start in the mid-teens and grow as the revenues grow to certain thresholds, in other words, grow into higher percentages from the mid-teens.

Speaker Change: Also net royalty.

Speaker Change: Our royalty on net sales gives me to finish.

Jeff Hackman: Now, regarding our partnership with Norgine to commercialize PED Mark C in Europe, Australia, and New Zealand, efforts continue to progress these territories and our targeted launch, late Q4 2024, and this remains on track. As a reminder, under the terms of the licensing agreement, Phenic received approximately 43.2 million in upfront consideration and the potential of up to approximately 230 million in additional commercial and regulatory milestone payments and tiered royalties on the net sales of PED Mark C in these licensed territories up to the mid-20s.

Speaker Change: And that will start in the mid teens and grow as the as the revenues grow to certain thresholds in other words grow into higher percentages from the mid teens.

Raghuram Selvaraju: Okay, great. I wanted to also see if Jeff would be prepared at this point to comment on the kind of historical experiences that he's had, specifically with regard to a situation that might be analogous to this one, where there is a clear difference in safety profile, in overall risk profile between a branded agent and a compounded agent or a generically available agent. And if there are any specific aspects, you know, with regard to his past history with commercialization of products and the specialty oncology arena, that could inform strategies that might be implemented here to speed up the uptake of PEDMARC.

Jeff Hackman: Okay, great. I wanted to also see if Jeff would be prepared at this point to comment on the kind of historical experiences that he's had, specifically with regard to a situation that might be analogous to this one, where there is a clear difference in safety profile, in overall risk profile between a branded agent and a compounded agent or a generically available agent. And if there are any specific aspects, you know, with regard to his past history with commercialization of products and the specialty oncology arena, that could inform strategies that might be implemented here to speed up the uptake of PEDMARC.

Speaker Change: Okay great.

Speaker Change: I wanted to also see if you would be prepared at this point to comment on kind of historical experiences that he's had specifically with regard to.

Speaker Change: In a situation that might be analogous to this one where there is a clear difference in safety profile and overall risk profile between branded agent and a compounded <unk> generically available agents and if there is any specific aspects with regard to its past history with <unk>.

Jeff Hackman: Norgine will be responsible for all commercialization activities in these licensed territories and will hold all marketing authorizations in these licensed territories. The next major milestone will be evaluated after the launch of Germany in Q4 2024. As we previously communicated, this partnership represents an important step for achieving our mission of expanding PED Mark C to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity. These terms provided us with many important benefits, including an upfront payment for the solidifying our balance sheet, attractive economic terms providing a meaningful participation in the XUF success of PED Mark C, and an experienced partner to successfully launch PED Marksie in these licensed territories.

Speaker Change: <unk> of products.

Speaker Change: Especially oncology arena that could inform strategies that might be implemented here to speed up the uptake.

Jeffery Hackman: Yeah, it's a good question. Thank you, Ram.

Jeff Hackman: Yeah, it's a good question. Thank you, Ram. And I've had two specific experiences that relate very closely to this, and it's one of the reasons why I got excited about coming, one within the, while I was at Vaxhalta. And as we were moving a product from COG usage into the AYA market, and in that market, there was a product that was used that potentially could have some side effects in the AYA population looking at infertility.

Speaker Change: Yes, it's a good it's a good question. Thank you Emily.

Speaker Change: I've had two specific experiences that really.

Very closely to this and that's one of the reasons why I got excited about coming here.

Jeffery Hackman: And I've had two specific experiences that relate very closely to this, and it's one of the reasons why I got excited about coming here. One was when I was at Vaxalta and as we were moving a product from COG usage into the AYA market. And in that market, there was a product that was used that potentially could have some side effects in the AYA population, looking at infertility. And so we had to, and we did not have that issue with the current product that we moved into that market. So, very, very similar to what we're seeing here.

Speaker Change: One was in the.

Speaker Change: While I was at Baxalta.

Speaker Change: And.

Jeff Hackman: And so we had to, and we did not have that issue with the current product that we moved into that market. So, very, very similar to what we're seeing here. And I understand the levers that need to be pulled to make sure that customers understand that. And then the other reason why we're at use of pharma. And we were launching a product in the market there, and there was a current product that was used that had a Black Box Warning and had a higher safety threshold that they had to overcome in the usage of that. So in both instances, we had products that were safer but weren't being used, and we had to, you know, focus our messages to make sure that we got that across.

Speaker Change: And as we were moving product from.

Speaker Change: Coa.

Speaker Change: Usage into.

Speaker Change: <unk> market and in that market. There was a product that was used that potentially could could have some side effects.

Speaker Change: In the gateway population.

Speaker Change: Looking at in fertility and so we had to when we did not have that issue with the current product that we moved into that market. So very very similar to what we're seeing here and I understand the levers that need to be called to make sure.

Jeff Hackman: So in closing, we continue to see promising opportunities for PED Mark, including the steps we're taking to educate the marketplace along with executing on our commercial plans. We are looking forward to seeing the benefits of our actions in the coming months.

Jeffery Hackman: And I understand the levers that need to be pulled to make sure that customers understand that. And then the other was that, while we were at use of pharma, and we were launching a product in the market there, there was a current product that was used that had a black box warning and had a higher safety threshold that they had to overcome in the use of that. So in both instances, we had products that were safer but weren't being used, and we had to, you know, focus our messages to make sure that we got that across.

Speaker Change: That customers understand that and then the other was that why we're at use of pharma.

Robert Andrade: So with that, I'm going to turn the call back over to Robert to go over the financials for the quarter. Thank you, Jeff. Our press release contains details of our financial results for the second quarter of 2024, which can also be viewed on the investors and media section of our website. Rather than read through all of those details, my comment today will focus on some key financial results. As stated, the company recorded PED Mark net sales of 7.3 million for the second quarter of 2024.

Speaker Change: And we were launching a product.

Speaker Change: In the market there and there was a current product that was used that had.

Speaker Change: Yes.

Speaker Change: A black box warning and had higher safety.

Speaker Change: Threshold that they had to overcome in the usage of that so in both instances, we had products that were safer, but werent being used and we had to.

Speaker Change: Focus our messages to make sure that we got that across we did it through.

Jeffery Hackman: We did it through, you know, relationships with KOLs. We did it with execution in our commercial team, and we really did it by making sure that the message was clear, and the companies and my teams were able to get across that message effectively. And those are the things that I'm going to jump into quickly here. Very similar. So, and so that's why I think my experience can help.

Jeff Hackman: We did it through, you know, relationships with KOLs. We we did it with the execution of in our commercial team. And we really did it in making sure that the message was clear and that the companies were, and my teams were able to get across that message effectively. And those are the things that I'm going to jump into quickly here, very similar. So, and so that's why I think my experience, Right, and then the last question for me is, you know, from a strategic perspective, looking further down the road, maybe you can give us a sense of how you folks are thinking about BD opportunities, the possibility of broadening the portfolio within specialty oncology, going forward, possibly in some kind of synergistic manner that would make it even more efficient to promote, continue to promote, and And, you know, what might be some of the triggers that would influence when you might make a decision to bring on another product or two?

Robert Andrade: This represents an increase of approximately 120 percent compared to the same quarter in 2023. GNA for the second quarter of 2024 was 6.9 million, which compares to 5.5 million in the comparable quarter of 2023 and 5.8 million in the first quarter of 2024. This increased as largely attributable to the pre-commercialization efforts for potential European launch or partnership that we were exploring and expenses associated with the Nordgene transaction. As discussed on previous calls, we anticipate all major EU-related expenses to wind down in the second quarter of 2024.

Speaker Change: Relationships with Kols, we did it with.

Speaker Change: Execution.

Speaker Change: In our commercial team and.

Speaker Change: And we really did it and making sure that the message was clear in the companies and my teams were able.

Speaker Change: Two to get across that message.

Speaker Change: <unk> and those are the things that I'm going to jump in too quickly here very similar so so that's why I think my experience can help.

Raghuram Selvaraju: Right. And then the last question for me is, you know, from a strategic perspective, looking further down the road, maybe you can give us a sense of how you folks are thinking about BD opportunities, the possibility of broadening the portfolio within specialty oncology, going forward, possibly in some kind of synergistic manner that would make it even more efficient to promote, continue to promote, and differentiate the ULS. And, you know, what might be some of the triggers that would influence when you might make a decision to bring on another product or two?

Speaker Change: Great and then the last question from me is from a strategic perspective looking further down the road.

Speaker Change: Maybe you can give us a sense of how you folks are thinking about BD opportunities the possibility of broadening the portfolio within the specialty oncology.

Robert Andrade: Selling and marketing expenses include renumeration of our sales and marketing employees, dollars on marketing campaigns, such as sponsorships, trade shows, and presentations, and any activities to support marketing and sales, the company reported 4.6 million in selling and marketing expenses in the second quarter of 2024, compared to 2.4 million in the comparable quarter, and 5.8 million in the first quarter of 2024. The increase was largely attributable to higher payroll and increased market expenses related to the previously mentioned AYA initiatives.

Speaker Change: Forward, possibly.

Speaker Change: Kind of synergistic manner that would make it more efficient to promote continued to promote pet market in the U S.

Speaker Change: And what might be some of the triggers that would influence when you might take a decision to bring on another product or two.

Jeffery Hackman: Well, you know, I can, I can let Robert jump in on some of the things that he's done in the past here, but we've got a We've got to create a success story here for Ped Mart, no doubt in the US. And that's, that's priority number one for me. Once we do that, and we drive that potential to where we think it can be, yeah.

Robert Andrade: Well, you know, I can let Robert jump in on some of the things that he's done in the past here, but we've got to, We've got to create a success story down in the U.S. Priority number one. Once we do that, and we drive that potential to where we think it can be, yeah, I think those those are all things that we need to. Similarly, Ramin, you know our history.

Speaker Change: Well I can let Robert jump in on some of the things that he has done in the past year, but we've got a.

Robert Andrade: And finally to our cash position, we ended the first quarter with approximately 43 million in cash and cash equivalence. The decrease in cash over the first quarter of 2024 was as a result of cash expenses related to sales and marketing, and GNA described earlier, along with EU-related expenses, including those associated with the Nordgene transaction. Further, as a reminder, the next milestone related to our Nordgene agreement will be obtaining pricing approval in Germany, in which Fennec will have the opportunity to receive a 10 million euro milestone.

Speaker Change: We've got to create a success story here for Penguin no doubt in the U S and Thats.

Speaker Change: Thats.

Robert: Priority number one for me once once we do that and we drive that potential to where we think it can be.

Speaker Change: Yes.

Robert: Those are all things that we need to consider and I don't know elaborate if you want to comment on it similarly.

Robert Andrade: No, similarly, Ramin, you know our history is that we take one step at a time. We are very excited about our partnership in Europe, Pet Marxie, so I think we believe we're in really good shape there. And in the U.S., with bringing Jeff on, you know, we're going to bring that expertise and, as you mentioned, fill some gaps so that there will be a right time, but the opportunity is so great here with PEDMARC in the U.S. that we're focused on that.

Robert Andrade: We take one step at a time. We are very excited about our partnership in Europe and with Pat Marksey. So I think we believe we're in really good shape there. And in the U.S., with bringing Jeff on, you know, we're going to bring that expertise and, as you mentioned, fill some gaps so that there will be the right time. But the opportunity is so great here with PetMark in the U.S. that we're focused on that. And then, obviously, we have a global market for PetMark.

Speaker Change: Our history is.

Speaker Change: We take one step at a time.

Speaker Change: We are very excited about our partnership in Europe.

Speaker Change: On <unk>. So I think we believe we're in really good shape, there and then in the U S with bringing Jeff on.

Robert Andrade: Additionally, Fennec's royalties on net sales are anticipated to commence in the mid-teens upon launch in Q4 of 2024. With that, we anticipate that our cash and cash equivalence, as of June 30, 2024, when coupled with pet mark revenue assumptions in the recently announced licensing agreement for Europe and the Nordgene, will be sufficient to fund our planned operations for at least the next 12 months.

Speaker Change: We're going to bring that expertise and as you mentioned fill some gaps so that there will be a right time, but.

Speaker Change: The opportunity is so great here with pet market in the U S that we're focused on that.

Robert Andrade: And then lastly, obviously, we have global potential for PEDMARC. And so, and in particular, there are some very attractive markets for us to grow there alone, just with our sole product. So we'll look at everything and anything, but the reality is we feel really good about what we have here today to grow on.

Speaker Change: And then lastly, obviously, we have global four for pet market and so and in particular, there are some very attractive markets for us to.

Robert Andrade: And so, and in particular, there are some very attractive markets for us to grow in there alone, just with our sole product. So we'll look at everything and anything, but the reality is, we feel really good about what we have here today to grow on. Great. And then, very quickly, I think this is one for you, Robert. What do you expect to be the key factors that would influence putting you folks in a position to start to offer a more formal revenue guidance framework for us, you know, going forward?

Speaker Change: To grow there alone just with our with our sole product.

Speaker Change: So we will look at everything and anything but the reality is we feel really good about what we have here today to grow to grow off that.

Robert Andrade: And lastly, I would like to thank the investors for their support, as we take the necessary steps to regain market costs. We successfully sold the EU rights to Norgine in March 2024. We are currently seeing signs that the AY-A channel is open. And we look forward to sharing the next chapter of Fennec and the introduction of Jeff and his expertise in the coming weeks through various conferences and investor discussions, including Wedbush this week and H.C. Winewright and Cantor in September of 2024.

Raghuram Selvaraju: Great. And then, very quickly, I think this is one for you, Robert.

Speaker Change: Great and then very quickly I think this is one for you Robert.

Robert Andrade: What do you expect to be the key factors that would influence putting you folks in a position to start to offer a more formal revenue guidance framework for us, you know, going forward? And what do you expect the potential timing of that to be? At this juncture, looking at everything that's in front of you, would you anticipate that that could start to occur by the end of this year, or is that more likely to occur in 2025? Thanks. Yeah, no problem. No, this is something different.

Robert: What do you expect to be the key factors that would influence putting your folks in a position to start to offer a more formal.

Robert Andrade: And what do you expect the potential timing of that to be? At this juncture, looking at everything that's in front of you, would you anticipate that that could start to occur by the end of this year? Or is that more likely to occur in 2025?

Robert: Revenue guidance framework for us going forward and what do you expect the potential timing of that to be at this juncture looking at everything that's in front of you folks.

Speaker Change: Do you anticipate that that could start to occur by the end of this year or is that more likely to occur in 2025.

Operator: And operator, with that, we are ready for questions.

Robert Andrade: Thanks. Yeah, no problem. No, this is something that I'm committed to and Jeff and I have spoken with in our first meeting. We, as you know, have really two buckets here in the U.S. that are going to drive this growth, both with the traditional pediatric population, the COG centers, and with the AYA. So I would anticipate as we move forward that you will be getting more guardrails around what our expectations are. But no, this is something that we are focused on and feel it's appropriate to present to both analysts and investors.

Robert Andrade: Yeah, no problem. No, this is something that I'm committed to, and Jeff and I spoke with each other in the first week. We, as you know, have really two buckets here in the U.S. that are going to drive this growth, both with traditional pediatrics, the COG centers, and with AYA. So I would anticipate as we move forward that you will be getting more guardrails around what our expectations are for the country. But no, this is something that we are focused on and feel is appropriate to present to both analysts and investors.

Operator: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please first star 1-1 on your telephone. If your question has been answered, you are wishing to move yourself from the queue. Please first star 1-1 again.

Speaker Change: Yes, no problem no. This is something that I am committed to and Jeff and I have spoken with in the first week.

Speaker Change: We as you know have really two buckets here in the U S that are going to drive this growth.

Operator: We will pass for a moment while we compile our Q&A roster.

Speaker Change: Both with the traditional pediatric with <unk> centers and with the AIA. So I would anticipate as we move forward that you will be getting.

Chase Knickerbocker: Our first question comes from Jason Nicabach with Craig Allen. Your line is open. Good morning.

Speaker Change: More guardrails around what our expectations are for the company.

Jeff Hackman: Thanks for taking the questions and Jeff congrats on the neural. Maybe on that note, maybe you speak to Jeff, maybe you speak a little bit more as to what you saw here at Fennec that really got you excited to join the team. And then even more so kind of what opportunities you saw with your skillset and experiences to come in here and quickly create shareholder value institute, maybe some things that you had at previous companies around commercial execution, commercial excellence, etc.

Jeff Hackman: That you think you can create shareholder value with here at Fennec. I'm excited to be on the call today and I have seen some things and I did in my preparation to come here. I was excited to lead Fennec in this role because I did see a significant opportunity here. There's talent. You know, there is leadership experience that I've seen and it's a great jumping point and great start for me. I've got the experience chased to understand where the opportunities are and I'm excited to bring that here.

Speaker Change: No. This is something that we are focused with him until it is appropriate to present to both analysts and investors.

Speaker Change: Thank you.

Operator: And I'm not showing any further questions at this time. I'd like to turn the call back over to Jeff for any closing remarks.

Operator: Thank you. And I'm not asking any further questions at this time. I'd like to turn the call back over to Jeff for any closing remarks. Well, thank you, everybody. I appreciate you joining the call today and all of your continued support. You know, I look forward to updating all of you in the future on our ongoing commercial progress and success and the corporate milestones on future quarterly calls. So I want to thank you and appreciate it and hope you guys all have a great day. Thank you, ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Speaker Change: Thanks, Rob and I'm not showing any further questions I'd like to turn the call back over to Jeff for any closing remarks.

Jeffery Hackman: Well, thank you, everybody. I appreciate you joining the call today and all of your continued support. You know, I look forward to updating all of you in the future on our ongoing commercial progress and success and the corporate milestones on future quarterly calls. So I want to thank you and appreciate it and hope you guys all have a great day.

Speaker Change: Well. Thank you everybody I appreciate you joining the call today and all of your continued support.

Speaker Change: I look forward.

Speaker Change: <unk> all of you in the future on our ongoing commercial progress and success in the corporate milestones.

Speaker Change: On future quarterly calls so I want to thank you.

Speaker Change: Appreciate it and hope you guys all have a great day.

Operator: Thank you, ladies and gentlemen. This concludes today's presentation. You may now disconnect. Have a wonderful day.

Speaker Change: Thank you ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Jeff Hackman: I've got experience in these markets. I've got experience not only in the PDA through COG institutions but also moving a product from PDA through the AYA space. So right now I'm identifying gaps and I'm looking to see where I can have some quick wins and move the company forward. So I'm looking forward to talking more about my experiences and what I'm going to be planning here. Great.

Robert Andrade: And then we spoke to AYA progress in the press release and also briefly on the call. He used maybe give us a little bit more of a window into what we're seeing so far through July and into August. I mean, if we've seen quite a few physicians adopt, try a couple patients, have we seen some more high-volume adopters?

Robert Andrade: How should we think about the progress thus far and was that largely unlocked from the NTCN guideline kind of worrying change? And then what are the dating factors still there in AYA that kind of need to be addressed? You mentioned the compendium. Just kind of speak to how you kind of see Q3 kind of developing from the AYA set. Thanks, Chase. It's Robert. I'll take the bulk of that question. As you know, we've laid quite a bit of foundation and worked the last several quarters in preparing for and hopefully manifesting this AYA opportunity.

Robert Andrade: Part of that work included the updating of the NCCN guidelines, which we were pleased with and successful with. But I think really early on in this quarter, what we're seeing are institutions becoming more aware of Pennmark. And that's really a credit to our commercial team. As they become more aware and they get reimbursed, we start to see some follow-through. And we're pleased with that, again, in July and going into August. And it's just, you know, it's really just the tip.

Robert Andrade: But that's starting to come through and I think that's hopefully what is being messaged to you. And is it also being successful in getting the clinics to stay open later? Are we treating these patients? Are we infusing them in the home setting? I mean, just going to walk through maybe that logistical challenge and how that's kind of played out? Yeah, it's a good question. It's a combination of both. What we also even alluded to in our script and our commentary was the Orcini partnership that we have, which we've started to see some traction there.

Robert Andrade: And that includes either bringing a home nurse to the patient or bringing it through a white bag to the actual oncologist. And important with that is also the reimbursement. And so I think we signal the few large payers that have reimbursed. And so that's, again, quite a bit of progress over the last quarter. And then lastly to your question in terms of clinics, we have, depending on the clinics, been able to get them to keep their hours open, etc. But I think it's really a combination of both and we anticipate that going forward. Got it.

Robert Andrade: And then just maybe, you know, how has the pediatric business, how did it kind of play out in Q2? You know, I think it was kind of down, it was obviously down modestly sequentially. Do you think that that business is kind of found its footing now?

Robert Andrade: And you know, you expect it to kind of be the bottom there or kind of walk through how we should think about the pediatric business from here? Yeah, I'll take that as well. Starting I think maybe Jeff can add in some of the experience on the pediatric side. But if you notice in a very small population, we have some a great base of business there in terms of some centers and some hospitals and some KOLs that really understand the product and the benefits.

Robert Andrade: Do we think there's an opportunity to continue to grow, yes? But again, we're really have that stable base with us. There's Ebb and flow in every quarter. And I think part of what Jeff's doing here and what he's going to bring in here is bringing in a two-pronged focus so that we continue to make traction on that AYA while at the same time also, you know, evaluate that opportunity within the traditional pediatric.

Robert Andrade: Yeah, I think there's an opportunity still there. So we'll continue to look at the levers that we need to pull, and what the institution has been and what it should be going forward with these pediatric institutions. So it's something I'm evaluating.

Robert Andrade: Got it, then just last for me guys and sorry for all the questions. But just with kind of the combination of those two starting to see progress in AYA and you know, pediatric, you know, seeming, you know, be a stable, you know, a stable business. Kind of put your commentary there and you know, kind of potentially, you know, trying to return that to growth obviously. Would you expect this the business as a whole with those two, you know, parts to start to grow meaningfully sequentially again.

Robert Andrade: And then again, I'll hop back in the queue. But grow meaningfully sequentially again from here is what I mean. Thanks. Sorry, maybe Jeff, I mean, Jeff's on day seven. We are here to grow meaningfully. Jeff's here to grow meaningfully and to help us grow meaningfully. So that's that's always our goal. I wouldn't have come. If that wasn't the case, so that's our plan. Thank you. Yeah, I appreciate your questions. One moment. One moment for our next question.

Naureen Quibria: Our next question comes from Nareem Corbira with capital one securities. The light is open. Hi, good morning. And yeah, Jeff, congratulations on the new row. Rusty will be missed. But it's my first question sort of following up on one of chasing questions, which is on the AYA opportunity. I believe on the last call, you know, there were plans to conduct pilot studies in the community setting. Could you sort of comment on what's happening there or the progress there.

Naureen Quibria: Yeah, Noreen, thank you for the question and always the interest. Yes, you're correct. We've been able to make progress and traction and that goes to our commentary with some of these new institutions. And the good news is that we are seeing reimbursement from these institutions and that eventually will come with follow through. So the answer to your question is yes, we've had success there and we hope to continue to build off that here in Q3 and beyond.

Naureen Quibria: Okay, got it. And then can you just sort of comment a bit more on the compounding issue? I mean, how prevalent is it now still? I mean, that's that's part of what we're going to evaluate on the pediatric side. We clearly know the value of pedmark, all the clinical studies that we've done there and the benefit to the patients. And so is that one of the challenges within the pediatric side? Yes, but we feel with execution and the proper approach and maybe Jeff can add a little bit to this that we can continue to grow that side of the business as well.

Naureen Quibria: Yeah, right. I think there's I know there's opportunity there. It's about the message and is the message being heard? Is it being delivered? And the execution of how it's being delivered? These are all areas where I'll be focused in my efforts here early on and quickly to understand what execution looks like there.

Jeff Hackman: And I look forward to sharing more once I start to kind of dive in, of that approach.

Naureen Quibria: And just one more from me.

Jeff Hackman: Are you planning to backfill the COO role now or? I'm looking at where we need to put our talent and the folks that I need to potentially bring in. So I can let you know. I haven't thought that through of what positions and the gaps I need to fill just yet. I'm evaluating that. My plan is I'm meeting with everybody in the organization. We're all doing one-on-one throughout these next week or so. And then I can assess gaps going forward and what needs to be filled and where. And we do. Thank you.

Naureen Quibria: That's all from me. Thanks, Lauren.

Raghuram Selvaraju: One moment for our next question. Our next question comes from Raghuram Selvaraju with AC Rainwright. Your light is open. Hi. Thanks very much for taking my questions. Can you hear me? Yes, Ron. How are you? Very good.

Jeff Hackman: And Jeff, congratulations on your new role. Very exciting. So I wanted to ask about specifically the context with respect to the next milestone from Norgine. And if you could maybe give us a little bit more color on how that's likely to be earned and how you would recognize it, and what has earned. Yes, as mentioned, the plan is to launch at Marxi in Q4. The first market we will launch at Marxi with Norgine will be in Germany.

Jeff Hackman: And the first milestone is related to achieving a certain price for the product in Germany. We are excited about that opportunity. We are optimistic about it. And so assuming we achieve that in the Q1 time period, then we would recognize that 10 million euros to Fennec, and we would get the cash into the company. And then secondly, you didn't specifically ask this, but there is a net royalty on net sale, excuse me, to Fennec. And that will start in the midteens and grow as the revenues grow to certain thresholds. In other words, grow into higher percentages from the midteens.

Jeff Hackman: Okay, great. I wanted to also see if the cash would be prepared at this point to comment on historical experiences that he's had specifically with regard to a situation that might be analogous to this one where there is a clear difference in safe profile in overall risk profile between a branded agency. And a compounded agent or a generically available agent. And if there's any specific aspects, you know, with regard to his past history with commercialization of products and the specialty oncology arena that could inform strategies that might be implemented here to speed up the uptake of pet mark.

Jeff Hackman: Yeah, that's a good question. Thank you, Ramana. I've had two specific experiences that relate very closely to this, and it's one of the reasons why I got excited about coming here. One was in the wild, I was at Faxalta, and as we were moving a product from COG usage into AYA market, and in that market there was a product that was used that potentially could have some side effects in the AYA population, looking at infertility, and so we had to, when we did not have that issue with the current product that we moved into that market, so very, very similar to what we're seeing here, and I understand the levers that need to be pulled to make sure that customers understand that, and then the other was that why we were at use of pharma, and we were launching a product in the market there, and there was a current product that was used that had a black box warning and had a higher safety threshold that they had to overcome in the usage of that, so in both instances we had products that were safer, but weren't being used, and we had to focus our messages to make sure that we got that across.

Jeff Hackman: We did it through relationships with KOLs, we did it with execution in our commercial team, and we really did it in making sure that the message was clear, and the companies and my teams were able to get across that message effectively, and those are the things that I'm going to jump into quickly here, very similar, so that's why I think my experience can help.

Jeff Hackman: Right, and then the last question from me is from a strategic perspective looking further down the road, maybe you can give us a sense of how you folks are thinking about BD opportunities, the possibility of broadening the portfolio within specialty oncology, going forward possibly in some kind of synergistic manner that would make it even more efficient to continue to promote PED Mark in the US, and what might be some of the triggers that would influence when you might take a decision to bring on another product or two? Well, you know, I can let Robert jump in on some of the things that he's done in the past year, but we've got to create a success story here for PED Mark, no doubt, in the US, and that's priority number one for me.

Jeff Hackman: Once we do that, and we drive that potential to where we think it can be, yeah, I think those are all things that we need to consider, and I don't know Robert, if you want to comment on it. No, similarly, you know, our history is we take one step at a time, we are very excited about our partnership in Europe and PED Mark see, so I think we believe we're in really good shape there, and in the US, with bringing Jeff on, you know, we're going to bring that expertise, and as you mentioned, fill some gaps, so that there will be a right time, but you know, the opportunity is so great here with PED Mark in the US that we're focused on that.

Jeff Hackman: And then lastly, obviously, we have global for PED Mark, and so, and in particular, there's some very attractive markets for us to grow their alone just with our sole product. So we'll look at everything and anything, but the reality is we feel really good about what we have here today, so it's a grow up to grow up.

Robert Andrade: Great, and then very quickly, I think this is one for you, Robert. What do you expect to be the key factors that would influence putting you folks in a position to start to offer a more formal, you know, revenue guidance framework for us, you know, going forward, and what do you expect potential timing of that to be? At this juncture, looking at everything that's in front of you folks, would you anticipate that that could start to occur by the end of this year or is that more likely to occur in 2025?

Robert Andrade: Thanks. Yeah, no problem. No, this is something that I'm committed to, and Jeff and I have spoken with in the first week. We, as you know, have really two buckets here in the US that are going to drive this growth, both with the traditional pediatric, the COG centers and with the AYA. So, I would anticipate as we move forward that you will be getting more guardrails around what our expectations are for the company. But no, this is something that we are focused with and feel is appropriate to present to both analysts and investors.

Operator: Thank you. Thanks, Ron. And I'm not showing any further questions at the time.

Jeff Hackman: I've turned the call back over to Jeff for any closing remarks. Well, thank you everybody. I appreciate you joining the call today and all of your continued support.

Operator: You know, I look forward updating all of you in the future on our ongoing commercial progress and success and the corporate milestones on future quarterly calls. So, I want to thank you and appreciate it and hope you guys will have a great day. Thank you, ladies and gentlemen.

Operator: That concludes today's presentation. You may now disconnect and have a wonderful day.