Q1 2024 Biofrontera Inc Earnings Call
Jimmy: [music].
Operator: Welcome to the Biofrontera Inc. First Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's prepared remarks, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Andrew Barwicki with Barwicki Investor Relations. Please go ahead.
Welcome to the bio Frontera, Inc. First quarter 'twenty 'twenty, four financial results and business update conference call.
Speaker Change: At this time all participants are in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero. After today's prepared remarks, there will be an opportunity to ask questions.
Speaker Change: To ask a question you May press Star then one on your telephone keypad to withdraw your question. Please press Star then two.
Speaker Change: Note. This event is being recorded.
Speaker Change: I would now like to turn the conference over to Andrew Burd wiki with our wiki Investor Relations.
Andrew Barwicki: Please go ahead.
Andrew Barwicki: Good morning, and welcome to Biofrontera Incorporated's first quarter 2024 financial results and business update conference call. Please note that certain information discussed during today's call by management is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that Biofrontera's management will be making forward-looking statements and that actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
Speaker Change: Good morning, and welcome to bio Fonterra Incorporated's first quarter 2024 financial results and business update conference call.
Speaker Change: Please note that certain information discussed during today's call by management is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners that bio friend tower's management will be making forward looking statements and that actual results may differ materially from those stated or implied by these forward looking statements due to risks.
Speaker Change: And uncertainties associated with the company's business.
Andrew Barwicki: All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in Biofrontera's press release and certain SEC filings. Also, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 16, 2024.
Speaker Change: All risks and uncertainties are detailed in and are qualified by the cautionary statements contained in battlefront terrorists press release certain S E T filings.
Speaker Change: Also this conference call contains time sensitive information that is accurate only as of the date of this live broadcast May 16 2024.
Andrew Barwicki: Biofrontera undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, there will be references to certain non-GAAP financial measures. Biofrontera believes these measures provide useful information for investors, yet should not be considered as a substitute for GAAP, nor should they be viewed as a substitute for operating results determined in accordance with
Speaker Change: By Fonterra undertakes no obligations to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except as required by law.
Speaker Change: During today's call there'll be references to certain non-GAAP financial measures.
Speaker Change: A friend Terra believes these measures provide useful information for investors, yet should not be considered as a substitute for GAAP, nor should they be viewed as a substitute for operating results determined in accordance with GAAP.
Andrew Barwicki: A reconciliation of non-GAAP to GAAP results is included in the press release announcing Q1 fiscal year 2024 results. More specifically, management will be referencing Adjusted EBITDA, a non-GAAP financial measure defined as net income or loss excluding interest income and expense, income taxes, depreciation, and amortization, and certain non-recurring or non-cash items.
Speaker Change: A reconciliation of non-GAAP to GAAP results is included in the press release announcing Q1 fiscal year 2024 results.
Speaker Change: More specific degree management will be referencing adjusted EBITDA, a non-GAAP financial measure defined as net income or loss, excluding interest income and expense income taxes, depreciation and amortization and certain nonrecurring or non cash items with that said I would like to turn the call over to Hermann Lyubertsy Euro C E O chairman and founder of <unk>.
Hermann Luebbert: With that said, I would like to turn the call over to Hermann Lubbert, CEO, Chairman, and Founder of Biofrontera.
Speaker Change: Frontier Herman.
Hermann Luebbert: Thank you, Andrew, and many thanks to everyone joining us this morning. On today's call, I'll provide an overview of our operations during the first quarter, some events that have occurred since the end of the first quarter, and discuss our business strategy for the remainder of the year. Fred Leffler, our CFO, will follow with a discussion of the financial results, and then both of us will be happy to answer questions. I would like to start with the most positive event of the first quarter.
Ed: Thank you Ed.
Speaker Change: Thanks to everyone joining us this morning.
On today's call I'll provide an overview of our operations during the first quarter some events that occurred since the end.
Speaker Change: The first quarter and discuss the all business classes for the remainder of the year.
Speaker Change: But net flow our CFO will follow with a discussion on financial results and then both of US would be happy to answer questions.
Speaker Change: I would like to start with the most positive people end of the first quarter we.
Hermann Luebbert: We successfully renegotiated our license and supply agreement for Amelus with Biofrontera AG, reducing our costs significantly. We will now be paying 25% for AMELUs during 2024 and 2025 compared to approximately 40-50% of our sales price under the prior agreement. This LSA will gradually step up to 35% by 2032. Any indication associated with ACNA will remain at 25% indefinitely.
Speaker Change: We successfully renegotiated a large consensus I believe on pharma lose less volume from Ted I E G.
Speaker Change: Oh, well cost significantly.
Speaker Change: We will now pay.
Speaker Change: They'll be paying 25% for envelope stealing 'twenty 'twenty, four and 'twenty 'twenty five compounds to approximately 40% to 50% of all lawsuits pause under the polyol agreement.
Speaker Change: This let's say will gradually step up to 35% by 2032.
Speaker Change: Any indication associated with Okta literally man at 20 plus percent indefinitely.
Hermann Luebbert: This represents a transformational event for Biofrontera Inc., significantly increasing our potential to become profitable in the near term. As part of this amendment, we will take over all U.S. clinical trials effective June 1, which will allow for more effective cost management and direct oversight of trial efficiency. The reduced costs of goods will allow us to finance R&D activities while continuing our commercial growth trajectory.
Speaker Change: It's the total national Eventful Biopharma, Inc, significantly increasing all potential it'll become more visible yet.
Speaker Change: As part of this amendment.
Speaker Change: We will take all of the all U S clinical trial, it's effective June one.
Speaker Change: Which will allow for more effective cost management and direct oversight.
Speaker Change: We could see.
Speaker Change: The reduced cost of goods.
Speaker Change: All of us to finance, the R&D activities, while continuing all commercial golf trajectory.
Hermann Luebbert: With AMELUS making up most of our revenue, we believe this is a unique opportunity moving forward. Furthermore, I am pleased to announce that in February we raised $8 million, minus financing expenses, to support the growth and expansion of the company, including clinical trials. Later, the cost of the clinical trials will be covered in entirety by the savings from the reduced transfer price. Additionally, our February financing deal entailed warrants exercisable upon achievement of certain milestones by April 30th at the earliest.
Speaker Change: With the envelope, making up most of all of the new we believe this is a unique opportunity moving forward.
Speaker Change: Cause them, all I am pleased to announce doesn't suddenly realized $8 million.
Speaker Change: Minus five net financing expenses.
Speaker Change: To support the goal of an extension of the company, including clinical pause.
Speaker Change: Later because of the clinical trial will be called out an entire T by the savings from reduced wentzville pause.
Speaker Change: Although February financing deal and to the warrants exercisable upon achievement of certain milestones by April Claudius at the earliest.
Hermann Luebbert: As we confirmed earlier this month, we have already met those milestones and, as a result, received another $8 million through the exercise of the warrants in early May. However, contrary to these positive developments, our quarterly revenues were negatively impacted when, in February, a cyberattack against Change Healthcare, the largest billing and payment system in the US, affected thousands of medical practices. According to the AMA, the American Medical Association, 80% of physicians reported lost revenues from unpaid claims. The AMA, which is the nation's largest medical society, said the attack threatened the viability of physician practices across the country, with more than half of survey respondents having to use personal funds to cover practice expenses.
Speaker Change: As we confirmed earlier this month, we have full that'd be met those milestones and as a result achieved another $8 million, who would be exercised an off the wall and O&M.
Speaker Change: We've made.
Speaker Change: Contrary to these positive developments or quarterly 11 used were negatively impacted by then hopefully a sidebar attack against change hotel, the largest billing and payment system in the U S affected thousands of medical practices.
Speaker Change: According to the a M E. The American Medical Association.
Speaker Change: 80% of physicians reported lost revenue was from unpaid claims yeah. It may but.
Speaker Change: Which is the nation's largest medical society since the attacks. So that's the viability of physician practices across the country with more than half or so they have a small number so I think to use personal funds to cover those expenses.
Hermann Luebbert: Healthcare reimbursement is a never-ending challenge with many changes occurring on a constant basis, purposeful or not. Having said that, I am extremely proud of our team and the efforts with medical facilities, doctors' offices, and insurance companies to tackle the working capital issues created by the Q1 Change Healthcare cyberattacks and to ensure full reimbursement is received wherever possible. We are working hand-in-hand with our customers, whether they are a small single provider office or a large medical facility to ensure they have our products available and are appropriately reimbursed for their service to the patient. In spite of everybody's efforts, all this culminated in some customers either reducing their orders in Q1 or shifting their orders into Q2, which drove 9% lower Q1 revenue as compared to the first quarter of 2023.
Kelly: Hi. This is Kelly endorsement is a never ending challenge with many changes are calling on a constant basis purposefully launch.
Speaker Change: Having said that I'm extremely proud of our team and I felt smiths medical facilities doctors offices and insurance companies to take the working capital issues created by the Q1 change has got saw the attacks and to ensure a poorly endorsement. This once ive about possible.
Speaker Change: We are working hand in hand, with all customers, but they're all small single provider office.
Speaker Change: All our large medical facility.
Speaker Change: Ensure that has all of our products over and above end up appropriately reimbursed for their service to the patients.
In spite of all these efforts all this gluten and some customer either reducing the orders in Q1.
Speaker Change: Shifting the autos into Q2, which 12, 9% lower coupon 11 U S compared to the first quarter in 2020 fleet.
Hermann Luebbert: However, as we announced earlier, we have begun to see recovery, and as of year-to-date, April 30th, 2024, compared to the same period last year, we have already reported more than 5% growth in revenues. Our BF Rotolat lamps, the devices that are used in combination with Amelus, continue to be placed at physician offices throughout the country. A positive indicator for future growth is that in the first quarter of 2024, we placed 28 lambs, an increase of 115% compared to the first quarter of the prior year.
Speaker Change: However, as we announced earlier, we have begun to see licavoli.
Speaker Change: And as of year to date April 30 of 2024 compared to the same period last year, we have football adult hedging embolden, plus some gold and other news.
Speaker Change: Our beautiful do that loves the devices that are used in combination with on the loose continue to be placed physician offices throughout the country.
Speaker Change: A positive indicator for future calls is that in the first quarter 2020 fold. We have placed 28 times, an increase of 115% compared to the first school at all to play out yet.
Hermann Luebbert: The growing number of LAMs in the field reflects both first-time installations and additional LAMs among dermatology practices already familiar with Amelu's PDT, facilitating growth through new and existing customers. We expect to begin selling the Rotolab XL, our larger five-panel lamp, towards the end of the second quarter this year.
Speaker Change: The growing number of labs and appeal to reflect both first time installations and additional among dermatology practices already familiar I'll, just I'm, a little speed your teeth, facilitating golf with new and existing customers.
Speaker Change: We expect to begin selling the older that ex <unk>.
Speaker Change: Our larger five standalone two boats.
Speaker Change: The second quarter of this year.
Hermann Luebbert: As part of the agreement with Biofrontera AG, we are in the midst of preparations for the takeover of the clinical trial departments of Biofrontera BIOS. As of June 1st, 2024, members of the clinical trial groups will join our wholly-owned German subsidiary, Biofrontera Discovery GmbH, which will subsequently be responsible for the management of all clinical trials with Amelus and Bay of Odelet in the United States. At Biofrontera Discovery, we will not only be responsible for future clinical studies but also for all ongoing trials. Currently, two clinical studies are enrolling patients, one for actinic keratosis on the neck and trunk and the arms and hands, and the other for moderate to severe acne. These have been recorded in 57% and 74% of subjects, respectively.
Speaker Change: As part of the agreement with Vodafone to L. A G. We are in the midst of populations for the take or both the clinical tires departments for biotech bioscience.
Speaker Change: As of June 1st Twenty-twenty for most of the clinical trial groups with Georgia, All wholly owned German subsidiary by also until just a couple of new G. M. P. H, which subsequently will be responsible for the management of all cause nickel tonnes I'm a loose on behalf of all of that in the United States.
Speaker Change: Total discovery, we will not only be responsible for future clinical studies, but also for all ongoing pilots currently two clinical studies are enrolling patients one for a difficult overseas on the neck and Tong and their arms and hands the other.
Speaker Change: Oh for moderate to severe acne.
Speaker Change: These tests are cool to 57% and 74% of subjects respectively.
Hermann Luebbert: The third ongoing study for the treatment of superficial breast and cell carcinoma is nearing completion of the one-year follow-up phase required for FDA submission. We expect the last patient to complete this follow-up phase before the end of the year. As I mentioned in the past, the Food and Drug Administration approved a new formulation of amylose without propylene glycol for the treatment of actinic keratosis. The production of this formulation will begin shortly, and we expect delivery at our wholesaler in August.
Speaker Change: The third ongoing study for the treatment of superficial basal cell carcinoma.
Speaker Change: It's nearing completion of the one year follow up phase required for FDA submission. We expect we expect the last patient to complete this follow up phase before the end of the year.
Speaker Change: Okay.
Speaker Change: As I mentioned in the past the food and drug administration approved a new formulation of <unk> with all propylene glycol.
Speaker Change: Lot of Actinic keratosis.
Speaker Change: The production of this formulation will begin shortly.
Speaker Change: And we expect delivery of all that's all I'll say about in August this would have improved to a loss of ability for some of our patients. While also reducing the generation of impurities overtime, which may result in an extended shelf life once sufficient stability data is collected.
Hermann Luebbert: This will help improve tolerability for some of our patients while also reducing the generation of impurities over time, which may result in an extended shelf life once sufficient stability data is collected. With that, I turn the call over to Fred to walk through the financial details of the first quarter.
With that I'll turn the call over to <unk> to walk through the financial details of the first.
Speaker Change: Walter.
Speaker Change: Yeah.
Speaker Change: Yeah.
Eugene Fredrick Leffler: Thank you, Hermann, and it is a pleasure to provide a financial update today on our first quarter results. Total revenues for the first quarter of 2024 were $7.9 million compared with $8.7 million for the first quarter of 2023. The decrease is due to healthcare reimbursement issues caused by the changed healthcare data breach that created cash challenges for the entire healthcare industry throughout the quarter. As Hermann mentioned, we have seen recovery, and I do not expect this to be a long-term issue and will continue to monitor for any further development.
Thank you Herman and it is a pleasure to provide a financial update today on our first quarter results.
Walter: Total revenues for the first quarter of 2024 were $7 9 million compared with $8 7 million for the first quarter of 2023.
Walter: The decrease is due to health care reimbursement issues caused by the change healthcare data breach that created cash challenges for the entire healthcare industry throughout the quarter.
Speaker Change: As Herman mentioned, we have seen recovery and I do not expect this to be a long term issue and we'll continue to monitor for any further developments.
Eugene Fredrick Leffler: Total operating expenses were $13.4 million for the first quarter of 2024 compared with $14.2 million for the first quarter of 2023. Cost of revenue was $4.1 million for the first quarter of 2024, compared with $4.6 million for the prior year quarter, with a decline in cost of revenue driven by lower AMLU sales. I've mentioned in earlier calls that we are burning through inventory that we have on hand for most of 2024.
Speaker Change: Total operating expenses were $13 4 million for the first quarter of 2024, compared with $14 2 million for the first quarter of 2023.
Speaker Change: Cost of revenue was $4 1 million for the first quarter of 2024, compared with $4 6 million for the prior year quarter with the decline in cost of revenue driven by the lower analyst sales.
Speaker Change: I've mentioned in earlier calls that we are burning through inventory that we have on hand for most of 2024.
Eugene Fredrick Leffler: Later this year, once we purchase new inventory, we expect to see the positive impact of the LSA amendment on our cost of revenue. Selling general and administrative expenses were $9.3 million for the first quarter of 2024, compared with $9.8 million for the first quarter of 2023. The decrease was primarily driven by a $1.1 million decrease in non-recurring legal costs and a $3,000 decrease in sales and marketing expenses.
Speaker Change: Later this year once we purchase new inventory, we expect to see the positive impact of the LSA amendments on our cost of revenues.
Speaker Change: Selling general.
Speaker Change: <unk> and administrative expenses were $9 3 million for the first quarter of 2024, compared with $9 8 million for the first quarter of 2023.
Speaker Change: The decrease was primarily driven by a $1 $1 million decrease in nonrecurring legal costs and a $3000 decrease in sales and marketing expenses.
Eugene Fredrick Leffler: The decrease was primarily offset by a $700,000 increase in fees and issuance costs associated with our most recent private placement transaction, as well as a small increase in personnel expenses. The net loss for the first quarter of 2024 was $10.4 million, or a loss of $2.88 per share, compared with a net loss of $7.5 million, or a loss of $5.60 per share, for the prior year quarter. I will note that the accounting for the B3 convertible preferred warrants had a large impact. We do not expect to have such an adjustment in the future.
Speaker Change: The decrease was primarily offset by a 700000 dollar increase in fees and issuance costs associated with our most recent private placement transaction as well as a small increase in personnel expenses.
Speaker Change: The net loss for the first quarter of 2024 was $10 4 million or a loss of $2 88 per share compared with a net loss of $7 5 million or a loss of $5 60 per share for the prior year quarter I will note that the accounting for the B three convertible preferred warrants had a large impact on us.
Speaker Change: We do not expect to have such an adjustment in the future.
Eugene Fredrick Leffler: Adjusted EBITDA for the first quarter of 2024 was negative $4.6 million, compared with negative $4.1 million for the first quarter of 2023. This reflects the lower revenues we saw in the first quarter of 2024. We look at adjusted EBITDA, a non-GAAP financial measure, as a better indication of ongoing operations, and this measurement is defined as net income or loss excluding interest income and expenses, income taxes, depreciation, and amortization, and certain other non-recurring or non-cash items.
Speaker Change: EBITDA for the first quarter of 2024 was negative $4 6 million compared with negative $4 1 million for the first quarter of 2023. This reflects the lower revenues we saw in the first quarter of 2024.
Speaker Change: We look at adjusted EBITDA, a non-GAAP financial matter excuse me measure is a better indication of the ongoing operations and this measurement is defined as net income or loss, excluding interest income and expenses income taxes, depreciation and amortization and certain other non recurring or non cash items I'll refer you to the table in the earnings press.
Eugene Fredrick Leffler: I'll refer you to the table in the earnings press release and the 10-Q we issued yesterday for a reconciliation of GAAP to non-GAAP financial measures. Turning to our balance sheet, as of March 31st, 2024, we had cash and cash equivalents of $3.8 million. Keep in mind we received $8 million from the exercise's B3 convertible preferred warrants on Tuesday, so we are in a much stronger position today. Our inventory balance as of March 31st, 2024 was $6.9 million.
Speaker Change: The release and the 10-Q, we issued yesterday for a reconciliation of GAAP to non-GAAP financial measures.
Speaker Change: Turning to our balance sheet as of March 31, 2024, we had cash and cash equivalents of $3 8 million keep in mind, we received.
Speaker Change: $8 million from the exercise of the <unk> convertible preferred warrants on Tuesday. So we are in a much stronger position today.
Speaker Change: Our inventory balance as of March 31, 2024 was $6 9 million.
Eugene Fredrick Leffler: As I mentioned, we are burning through our inventory, and we constantly monitor our inventory levels to ensure deliveries are made in accordance with our forecasts and we get to and maintain an industry standard of safety stock. Related to inventory, our assets include $5.2 million for replacement inventory. This is due to Biofrontera AG deciding on a voluntary recall of three batches of amylose. We were notified of the issue in February of 2024.
Speaker Change: As I mentioned, we were burning through our industry inventory and we constantly monitor.
Speaker Change: Our inventory levels to ensure deliveries are made in accordance with our forecast and we get to and maintain an industry standard of safety stock.
Speaker Change: Related to inventory our assets include $5 2 million for a replacement inventory. This is due to borrow for entire age you deciding on a voluntary recall of three batches of analysts we were notified of the issue in February of 2024 batches will be replaced at no cost to us and we expect to receive these batches in the third quarter.
Eugene Fredrick Leffler: The batches will be replaced at no cost to us, and we expect to receive these batches in the third quarter. This will not impact our ability to fulfill orders in the meantime. Finally... We had an outstanding balance of $2.4 million in short-term debt that we expect to pay down by early July 2024. With that overview of our business and financial performance, Hermann and I are now ready to take questions from our covering analysts.
Speaker Change: This will not impact our ability to fulfill orders in the meantime.
Speaker Change: Finally.
Speaker Change: We had an extended our outstanding balance of $2 4 million in short term debt that we expect to pay down by early July 2024.
Speaker Change: With that overview of the of our business and financial performance.
Speaker Change: Herman and I are now ready to take questions from our covering analysts.
Speaker Change: Later.
Speaker Change: Yeah.
Operator: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at this time, we will pause momentarily to.
Speaker Change: Assemble our roster.
Operator: The first question comes from Jonathan Aschoff with Roth. Please go ahead.
Speaker Change: The first question comes from Jonathan Aschoff with Roth. Please go ahead.
Jonathan Aschoff: My first question is, does that greater than five percent, you know, Jan through April sales result, is that a big underestimation of the actual growth that, you know, simply fits the definition of one of the two milestones you had to hit to trigger the second eight million dollar investment, or is it actually really close to five percent?
Jonathan Aschoff: Thank you. Good morning, guys. My first question is does that greater than 5% Jam through April.
Jonathan Aschoff: Sales result is that a big underestimation of the actual growth that you know simply fits the definition of one of the two milestones you've had to hit to trigger the second $8 million in investment or is it actually really close to 5%.
Eugene Fredrick Leffler: Hi Jonathan. Fred Leffler here. I can take that. That was based on the milestone, like you said, that we had to hit. We didn't issue the specific number, but we can give an update on Q2, or we'll give an update on Q2 in August.
Jonathan Aschoff: Hi, Jonathan.
Jonathan Aschoff: Over here I can take that.
Speaker Change: That was.
Speaker Change: Based on the milestone like you said that that we had to hit we.
Speaker Change: Didn't issue the specific number but can give them.
Speaker Change: An update on Q2 or will give the update on Q2.
Speaker Change: In August.
Jonathan Aschoff: Okay, are you guys still comfortable with cash flow break even around year-end 25, or has that changed a bit?
Speaker Change: Ah Okay are you guys still comfortable with cash.
Speaker Change: Cash flow breakeven around year end, 'twenty five or has that.
Speaker Change: Changed a bit.
Eugene Fredrick Leffler: That is still the expectation. As Hermann said, we are taking on the clinical costs, and we will start seeing the savings of the LFA amendments later this year through 2025 to help fund that. And as long as we operate and hit our budget numbers, don't perceive that as being an
Speaker Change: That is still the expectation.
Speaker Change: As determined as said we are taking on the.
Speaker Change: The clinical cost then we will start seeing the.
Speaker Change: Savings of the LSA amendments later this year through 2025 to <unk> to help fund that and as long as we operate and hit our budget numbers.
Speaker Change: Foresee that as being an issue.
Speaker Change: Okay I did the last basal cell carcinoma patient have their final assessment last quarter, and therefore, you're still expecting to give us data in the third quarter of this year.
Jonathan Aschoff: Okay, did the last basal cell carcinoma patient have their final assessment last quarter, and therefore, are you still expecting to give us data in the third quarter of this year?
Eugene Fredrick Leffler: That's correct. So the data we would provide, and we expect to provide, is for the clinical phase. The FDA wants us to submit the one-year follow-up, so the last patient out there would be in November or December, and so the follow-up data would be available early in Q2 and then prepared for FDA submission.
Speaker Change: That's correct. So the date I'll be able to provide we expect to provide I'll call. It the clinical phase.
Speaker Change: So the FDA wants us to submit the one year follow ups on the loss patient all to the al would be in November or December.
Speaker Change: Hum sort of a follow up data would be available.
Speaker Change: Early in Q2.
Speaker Change: White pouch for FDA submission.
Jonathan Aschoff: Okay, and I remember hearing, you know, from the prior management that dermatologists, if they had to cover a greater area and were only allowed to use one tube, they would use the amylose, you know, a little thinner than indicated so they could cover a greater area. Wouldn't that kind of, I don't know, imply that if they could use more than one tube, they would definitely do that so they could get a higher reimbursement per procedure?
Speaker Change: Okay, and I remember hearing.
Speaker Change: You know from the prior management that dermatologist, if they had to cover a greater area and you're only allowed to use one tube. They would use the animals as you know a little thinner than indicated they could cover a greater area wouldn't that kind of I dunno imply.
Speaker Change: Implied that if they can use more than one two that they would definitely do that so they can get a higher reimbursement per procedure.
Eugene Fredrick Leffler: Doctors, of course, if they can, tend to use the products according to the label, and payers are more and more looking after that. So our currently ongoing FDA submission for three tubes is very, very relevant in that respect. And the timeline there hasn't changed, so we expect... preliminary review results in early August, and then the PDUFA date in November.
Speaker Change: Doctors of course, if that sound tool.
Speaker Change: To use the product so according to label.
Speaker Change: They pay us more and more looking after that.
Speaker Change: Hum.
Speaker Change: So I'll go on to your ongoing submission FDA submission for <unk>, So, it's really especially relevant in Bob's inspect.
Speaker Change: So the timeline Dal Hasnt changed so we expect.
Speaker Change: Hum.
Speaker Change: Some kind of preliminary view results in early August.
Speaker Change: The Purdue date is in November.
Jonathan Aschoff: Okay, could you just help us with the enrollment for Acne and Peripheral AK?
Speaker Change: Okay.
Speaker Change: Could you just help us with the enrollment for acne and peripheral.
Speaker Change: Okay.
Eugene Fredrick Leffler: Yes, so the enrollment for Axte and Peripheral AK. I have the numbers in the presentation. Hold on a second. So for, um... For Peripheral AK, current enrollment is 57% of the patients, and for ACNA, it's 74% of the subjects. Thank you very much, guys.
Speaker Change: Yes, so the.
On the whole months fall.
Speaker Change: Okay.
Speaker Change: Okay I had the.
Speaker Change: The numbers in the presentation.
Speaker Change: So Paul.
Speaker Change:
Speaker Change: Second.
Speaker Change: So Paul.
Speaker Change: For political AK coal and enrollment is 57% of locations.
Speaker Change: Faulkner, it's 74% of the of the subjects.
Jonathan Aschoff: Thank you very much, guys; that was all.
Speaker Change: Thank you very much guys that was all.
Speaker Change: Thank you.
Operator: The next question comes from Bruce Jackson with the Benchmark Company. Please go ahead.
Speaker Change: The next question comes from Bruce Jackson with the Benchmark Company. Please go ahead.
Bruce Jackson: Hi, good morning, and thanks for taking my questions. I'm trying to kind of sort through the impact of changing health care. So we're up 5% year-to-date. How do you think the rest of the year unfolds? So the second quarter is generally seasonally weak, and then the back half of the year can have other anomalies to it. But how do you see the sales unfolding for the rest of the year?
Speaker Change: Hi, good morning, and thanks for taking my questions.
I'm trying to kind of certainty the impact from from change healthcare so.
Speaker Change: We're were up 5%.
Speaker Change: Year to date.
Speaker Change: How do you think the rest of the year unfolds. So second quarter is generally.
Speaker Change: Seasonally weakened in the back half you can have other anomalies to it but how do you see the sales unfolding for the rest of the year.
Eugene Fredrick Leffler: Well, as Fred said, we don't expect this to have a long-term impact. It had an impact mostly in February and March, when this actually happened, and doctors were not paid for all services. That's when all the services at doctors' offices actually came down, including, of course, PDT, which is on the loose. But then, in April, we did already see the upswing and could not only make up for the 90% loss, but, as we said, it's more than 5% above last year. So we don't expect a long-term effect of this and still expect the same kind of growth that we did at the beginning of the year.
Speaker Change: Well, so as I said.
Speaker Change: So we don't expect this to happen long term.
Bruce Jackson: Okay, okay. And then my second question is about the XL Lamp launch. I think I heard you're going to be receiving from the... I'm sorry, when is the XL Lamp going to launch? That's my question.
Speaker Change: Awesome.
Speaker Change: Mostly in February and March linguists actually happens.
Speaker Change: Those are not paid for.
Speaker Change: All surfaces.
Speaker Change: That's why when all the all of the services at doctors office has actually formed all of them, including of course BTT with on the loose.
Speaker Change: So, but then in April we did or how do you see the upswing so not all of them they make up for those 90% loss bumps as we set.
It's a small one plus percent above last year.
Speaker Change: So we expect we don't expect.
Speaker Change: A long term effect of all of this.
Speaker Change: Understood Steve.
Speaker Change: I would expect the same kind of goes like we did just a beginning of the year.
Speaker Change: Okay. Okay and then my second question is about the XL lamp launch I think I heard.
Speaker Change: You are going to be receiving from the I'm sorry, when does the XL lamp going to launch that's my question.
Eugene Fredrick Leffler: It's set to launch by the end of Q2.
Speaker Change: Oh, so to launch by the end of Q2.
Speaker Change: And if Q2.
Bruce Jackson: Okay, super. That's it for me. Thank you.
Speaker Change: Okay Super and that's it for me thank you.
Operator: Thank you both.
Speaker Change: Rich Thank you Bose.
Bruce Jackson: Thanks Bruce.
Hermann Luebbert: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.
Speaker Change: This concludes our question and answer session I would like to turn the conference back over to management for any closing remarks.
Hermann Luebbert: Yeah, well, thank you for everybody's time, participation, and questions. And we look forward to our next call, where hopefully, we can again present positive news. Thank you, and have a nice day.
Speaker Change: Yeah. It was thank you for everybody's time participation with questions.
Speaker Change: We look forward to next call well hopefully we come again present positive news. Thank you and have a nice day.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: [music].