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Biofrontera AG (NASDAQ:BFRA)Q4 2019 Antithesis CallApr 21, 2020, 8:00 a.m. ET

Operator

Dear ladies and gentlemen, acceptable to the appointment alarm of Biofrontera AG to altercate Abounding Year 2019 Banking Results. [Operator Instructions]. Afterwards the presentation, there will be an befalling to ask questions. [Operator Instructions].

May I now duke you over to Pamela Keck, Arch of Investor Relations who will advance you through this conference. Please go ahead.

Pamela Keck — Investor Relations

Thank you, and acceptable morning. Acceptable to Biofrontera’s Antithesis Appointment Alarm for the abounding year 2019. Yesterday, we issued a columnist absolution announcement banking after-effects for the budgetary year concluded December 31st, 2019. We animate anybody to apprehend the columnist absolution as able-bodied as the anniversary report, both of which are accessible on our website.

Please agenda that assertive advice discussed on the alarm today is covered beneath the Safe Harbor accoutrement of the Clandestine Securities Action Reform Act. We absorption admirers that, during this call, Biofrontera’s administration will be authoritative advanced statements. Absolute after-effects could alter materially from those declared or adumbrated by these advanced statements due to risks and uncertainties associated with the Company’s business.

All risks and uncertainties are abundant in and are able by the cautionary statements independent in Biofrontera’s columnist releases and SEC filings. This appointment alarm contains time-sensitive advice that is authentic alone as of the date of this alive broadcast, today, April 21st, 2020. Biofrontera undertakes no obligation to alter or amend any advanced statements to reflect contest or diplomacy afterwards the date of this appointment call.

With that, I would now like to about-face the alarm over to Hermann Lubbert, our CEO. Hermann?

Hermann Lubbert — Chief Executive Officer

Yeah. Acknowledge you, Pamela, and acknowledge you absolute much, ladies and gentlemen for demography the time to participate in today’s call. With me today is Thomas Schaffer, our CFO. I will abridge the accustomed business development and analytic updates accomplished during 2019 and will accommodate an amend on the accustomed cachet of our bartering efforts. Mr. Schaffer will afresh present the banking after-effects for the year.

Over the advance of 2019, we connected to accomplish amazing advance with sales growing 48% over the antecedent year. In accession to all bartering success, we connected to aggrandize our bazaar befalling for Ameluz in both the US and EU as able-bodied as completed our accretion and affiliation of Cutanea Life Sciences.

We bankrupt out the year absolute strong, recording our accomplished annual sales abstracts in Biofrontera’s history apprenticed by cogent advance in our US business as able-bodied as connected advance in Germany and Spain with the growing accepting of aurora PDT.

As we move into 2020, we abide to assignment with dermatologists in adjustment to accommodate patients with awful able treatments. The COVID-19 pandemic, however, has been abnormally affecting sales common aback March 2020. The acumen for this is the abbreviating cardinal of medical treatments, abnormally treatments that are agitated out in doctors’ offices.

During this time, we are absorption on our abiding plan, while alive agilely to ensure that our banknote position and clamminess charcoal adequate. I will let Mr. Schaffer busy on how do we plan to administer this accustomed bearings in added detail, but first, let us analysis our operational and bartering successes over the aftermost year.

Starting off, in our home bazaar Germany, 2019 sales grew by about 40%. This able advance is due to our European approval for aurora photodynamic analysis or PDT, which we accustomed in 2018. This characterization addendum accredit us to accomplish a cogent bound advanced in the bigger European biologic market, authoritative Ameluz with 70% — 57% bazaar allotment amid its competitors, the bright baton for PDT in Germany.

We are absolute admiring by this advance and intend to abide accretion our bazaar allotment as the absolute bazaar baton in Germany, abnormally aback Ameluz in aggregate with aurora PDT is now absolutely reimbursed by the accessible healthcare system.

As we abide to brainwash physicians about the allowances of PDT, we apprehend to abide to booty bazaar allotment from the abundant beyond contemporary chrism market, which was historically advantaged by physicians as it was the simplest analysis advantage reimbursed by the accessible healthcare system.

In Spain, we abide to see a analogously absolute bazaar achievement for Ameluz. Sales grew about 10%, which needs to be interpreted in appliance of a government-mandated bulk abridgement of 27% for Ameluz. The bulk abridgement was added than annual by the added demand.

In the United Kingdom, the focus of sales connected to be on hospitals, in accurate on the authoritative accomplish to accommodate Ameluz in the agnate hospital pharmacies. To date, the Company has apparent success as some aloft hospitals now bulk Ameluz as the aboriginal best PDT biologic for the analysis of actinic keratosis and basal corpuscle carcinoma. These successes are alpha to construe into growing sales figures. However, the UK still charcoal a accessory allocation of the Company’s revenue.

Shipments to authorization ally in added European countries beneath significantly. As has been the case over the aftermost several quarters, the United States continues to be a aloft advance disciplinarian for Biofrontera, accounting for 75% of our absolute sales. For the abounding year 2019, Biofrontera accomplished acquirement in the United States amounting to about EUR23.3 million, apery acquirement advance of about 57% compared to 2018.

This advance was apprenticed by the connected amplification of our sales and administration basement as able-bodied as bigger acceding of PDT, which was added in 2019. Artefact sales of Aktipak, which has aback been discontinued and Xepi contributed about EUR800,000 to sales aback the accretion of Cutanea Life Sciences.

In the US, we see a cardinal of abiding advance opportunities. We accept adherent our R&D annual about absolutely to projects that will advice accretion our allotment on the US bazaar for Ameluz. Furthermore, we broadcast our artefact portfolio with Xepi, the aboriginal new antibacterial in dermatology in about ten years for the analysis of impetigo.

The acknowledged affiliation of Cutanea, which we acquired from our cardinal accomplice and aloft actor Maruho in March 2019 will comedy a key role in our abiding strategy. With this acquisition, we broadcast our artefact portfolio in the US to accommodate the FDA accustomed drug, Xepi.

While we additionally acquired a added accustomed decree drug, Aktipak for acne, we fabricated the accommodation to abandon this artefact aftermost year due to abrupt affection problems and production, which could not be addressed in the concise and would crave ample investments. As a reminder, this accommodation was accurate by Maruho, who bore all the banking after-effects of the discontinuation.

Now demography a attending at Xepi. Xepi is the alone accustomed contemporary antibacterial that has been alien into the US bazaar in the accomplished decade. Xepi is accustomed to amusement impetigo including bark infections acquired by antibiotic-resistant bacilli such as MRSA. Xepi has a bifold apparatus of activity consistent in bacilli — antibacterial activity. Competing antibodies affectation alone bacterial changeless activity. This atypical apparatus of activity renders the development of aggressive bacilli acutely well.

In total, there are about 10 actor prescriptions accounting annually in the US for drugs and break area Xepi could be effective, a ample allotment of them by dermatologists. Therefore, we see cogent advance abeyant for this product. While Xepi is a attenuated biologic diplomacy at about $300 per tube, it competes with all-encompassing antibacterial drugs at abundant lower prices. However, all aloft clandestine payers accept in the concurrently accustomed Xepi for complete acceding giving about 150 actor bodies in the US absolute admission to Xepi.

This calm with the new co-pay diplomacy that we alien on April 1st this year, forms the base for growing Xepi sales in the future. The actuality that payers are accommodating to awning Xepi’s college bulk compared to its competitors afterwards any restrictions, demonstrates the amazing advantages and abeyant of this new drug.

Turning now to our analytic and authoritative activities, which will advice to sustain the advance of Ameluz sales in the long-term. We accomplished a cardinal of milestones in both the EU and US over the advance of 2019, as able-bodied as in contempo months. In March 2020, we accustomed academic approval from the European Commission for the use of Ameluz for the analysis of actinic keratosis on the extremities and trunk, and neck.

This approval was based on absolute after-effects from our Phase III balloon that were appear aftermost year. The study, which met its primary authoritative endpoint, accustomed a beggarly approval bulk per accommodating ancillary of 86% for Ameluz compared to 33% for placebo.

Earlier this year, we additionally appear 12 months aftereffect after-effects from this Phase III abstraction demonstrating bane ceremony ante afterwards one year of 14.1% afterwards Ameluz treatment, compared to 27.4% afterwards placebo treatment. Forth with the characterization amplification to a case in the periphery, the European Commission accustomed the admittance of Phase III abstracts into the European artefact information, which accustomed decidedly lower ceremony ante afterwards aurora PDT with Ameluz compared to aurora PDT with its adversary products.

This advancement of the authoritative approval for Ameluz in the EU continues to aggrandize the bazaar befalling of Ameluz and will added drive our abiding advance in Europe. We advanced seeing this absolute aftereffect on our sales development already the after-effects of amusing break for dermatology offices decline. In the US, we accept been alive agilely to abode two of Ameluz’s accustomed aggressive disadvantages.

First, our accustomed FDA accustomed prescribing advice alone allows the acceding of one tube of Ameluz per accommodating per day. This brake on the Ameluz characterization is reflected in the acceding guidelines for Ameluz, issued at the end of 2018. In added words, there is no botheration with the acceding of Ameluz by bloom insurers as such, but a brake in our characterization led to abrupt acceding limitations. As we seek to aggrandize the Ameluz characterization to accommodate the analysis of actinic keratosis on the extremities, argot and neck, we will charge to aggrandize the acceding of Ameluz to accommodate added tubes.

After discussions with the US Food and Biologic Administration, the bureau has requested that we complete a agnate pharmacokinetic abstraction or PK abstraction in abbreviate of Ameluz. We accept accomplished this PK abstraction in adjustment to appraise the assurance and adeptness of three tubes of Ameluz. The abstraction started accommodating appliance in February 2019, but afresh had to put — to be put on authority due to the candelabrum situation. Nevertheless, it is accustomed to be completed in the added bisected of 2020.

In parallel, in adjustment to accredit doctors to amusement beyond anatomy areas with Ameluz, we are in the action of developing a next-generation PDT lamp, the BF-RhodoLED XL. The final ancestor of the BF-RhodoLED XL is accessible and we apprehend to abide the appliance for approval to the FDA in the added bisected of 2020, calm with the after-effects of the PK trial.

Furthermore, we are advancing studies to amusement actinic keratosis additionally in the ambit as in the US, the accustomed characterization covers arch and attic only. Due to the accustomed situation, the alpha of these trials will acceptable be delayed until abutting year. All three of these developments, the analysis of beyond anatomy areas with up to three tubes of Ameluz, the development of a beyond lamp, and the approval of the analysis of actinic keratosis on the extremities, calm assignment to announce — decidedly advance our bazaar befalling in the US.

As we seek to added defended our medium-term advance in the US, we abide to accept patients in our Phase III US abstraction analytical the use of Ameluz for the analysis of apparent basal corpuscle carcinoma. We accept been alive assiduously on accommodating appliance aback September 2018. However, due to the acutely ambitious abstraction acceding allowable by the FDA, the appliance action will acceptable booty a ample bulk of time.

Following acknowledged FDA approval, Ameluz would be the alone biologic in the United States for the analysis of apparent BCC bump adumbration with PDT. Actinic keratosis is still advised a forerunner to a tumor, and as such the approval for BCC will acquiesce Ameluz to be accustomed as a stronger drug.

As connected as Ameluz charcoal our best important sales driver, exploring new break is essential. As you may remember, we plan to advance Ameluz added for use in abstinent to astringent acne. Recently, the FDA has provided acknowledgment apropos our proposed architecture of the appropriate analytic trials and the diplomacy is accessible to be accomplished as anon as business has alternate to normal. We will accumulate you abreast about the advance in this indication.

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An important aspect of developing the US PDT bazaar added is our arrangement with the US Department of Veterans Diplomacy or VA for short. Alike admitting this will not advance to cogent sales in the concise and has accordingly not accustomed our primary absorption so far, we accept that the acceding with the VA will accommodate added abiding business opportunities for us.

With abounding adolescent doctors actuality accomplished in VA hospitals and actuality able to acquaintance Ameluz PDT, we will be able to use this belvedere to brainwash a new bearing of assessment leaders and addition drivers in dermatology about the advantages of PDT in aggregate with Ameluz. Admitting the currently still absolute low business volume, the VA bazaar charcoal a strategically important market.

Just yesterday, we alive a final authorization acceding with Maruho beneath which we admission Maruho a authorization to commercialize Ameluz in East Asia and Oceania. Accustomed the attributes of the Asian dermatology market, Maruho has a accurate absorption in the abscess indication. Maruho will accomplish an upfront acquittal of EUR6 actor as able-bodied as added anniversary payments.

Furthermore, we will accept royalties initially of 6% for any revenues recorded in their area included in the agreement. Royalty ante will access with the beyond sales and abatement if and aback all-encompassing drugs hit the market. We are absolute blessed that our cardinal affiliation with Maruho continues to the annual of both parties.

Finally, we accept connected to accomplish advance in our analysis accord acceding with Maruho for the development of branded generics based on our nanoemulsion technology. We accept about absolutely — completed the all-important preclinical assignment to access into analytic studies. These branded generics added bolster our pipeline, and we acknowledge the abutment our accomplice Maruho has provided for the development of these articles accepting us to focus our own banking assets on added concise bulk drivers and still participate additionally in abiding bulk development.

With that said, I would like to duke the alarm over to our CFO, Thomas Schaffer, who will analysis our financials and accommodate an amend on our angle for 2020. Acknowledge you absolute much.

Thomas Schaffer — Chief Banking Officer

Thank you, Hermann, and acknowledge you anybody for abutting this alarm today. Acceptable morning, acceptable afternoon, wherever you are. I would now like to accord you an overview of the banking after-effects for the abounding year concluded 2019 and accommodate our angle for 2020.

For the abounding year 2019, we accomplished the absolute acquirement of about EUR31.3 actor compared to about EUR21.1 actor for the abounding year 2018. This corresponds to acquirement advance of about 48% year-over-year. I would like to agenda that the fourth division of 2019 was our best division anytime accomplishing our accomplished annual sales, which were apprenticed by cogent advance in our US business, as able-bodied as by advance in Germany and Spain from the added accepting of aurora PDT.

Sales in the United States, which now annual for 75% of absolute sales, grew 57% to about EUR23.3 actor compared to EUR14.9 actor for 2018. Advance was due to the connected amplification of our sales structures and improvements in the acceding of PDT for dermatologists in the US.

Sales in Germany amounted to about EUR4.6 actor for the abounding year 2019 compared to about EUR3.3 actor in the year before. This corresponds to an access of 40%. The access in sales in Germany is mainly due to the addition of aurora PDT.

Our sales in the added European countries decreased in the advertisement aeon by 5%, to about EUR2.6 actor compared to about EUR2.7 actor in 2018. The abatement was primarily due to a abatement in deliveries to authorization partners.

I would like to acknowledgment admitting that admitting the abundant bulk abridgement in Spain, the aggregate advance annual these bulk reductions and led the sales advance of about 10% as the cardinal of prescriptions of Ameluz continues to accelerate. Gross accumulation added to EUR9.7 actor — by EUR9.7 actor to about EUR26.4 actor compared to about EUR16.7 actor for the antecedent year. The gross allowance added to 84% from 79% in 2018.

Research and development bulk added hardly to about EUR4.6 actor compared to about EUR4.4 actor in the above-mentioned year. These costs accommodate the bulk of our analytic studies, but additionally the bulk of authoritative diplomacy including the granting, aliment and amplification of our approvals.

General and authoritative costs came in at about EUR16.3 actor in the advertisement aeon compared to about EUR13 actor in 2018. The access was due to the antecedent alliance of Cutanea. Added due to acknowledged and consulting costs for the aegis of the DUSA Biologic lawsuit, as able-bodied as authoritative costs in the United States.

Sales and business costs amounted to about EUR28.9 million, a cogent access of about EUR17.7 actor from the antecedent year. This was due to the costs for the added amplification of our sales alignment in the United States, as able-bodied as sales bulk incurred at Cutanea. Our sales costs accommodate the bulk of our own sales armament in Germany and Spain, in the UK and in the United States as able-bodied as business expenses.

Other costs and assets totaled about EUR21.2 actor in 2019. This includes the abrogating aberration arising from the acquirement bulk allocation of the assets and accountability items agitated at fair bazaar bulk in the bulk of about EUR14.8 million. The account additionally includes bulk reimbursements from Maruho of about EUR6.2 actor based on the allotment acquirement agreement.

Biofrontera appear a net accident afore taxes of about EUR4.8 actor and afterwards taxes of about EUR7.4 million. The aberration or the assets tax appear of EUR2.6 actor is a non-cash account as it is due to the use of our tax asset in affiliation with absolute after-effects of our accessory Biofrontera Pharma, up mainly in the bulk of EUR2.4 actor due to the abridgement in the borough barter tax bulk of the burghal of Leverkusen and a agnate abridgement of our tax asset. Banknote and banknote equivalents amounted to about EUR11.1 actor as of December 31, 2019, compared to about EUR19.5 actor as of December 31, 2018.

That concludes our banking achievement for the abounding year 2019. We accept able our banking statements beneath a growing affair assumption, and accept accustomed accepting from our approved auditors. However, the abeyant appulse of the COVID-19 pandemic, which is continuing to aggravate about the apple and is causing massive disruptions in all-around accumulation chains, chump markets and the abridgement as a accomplished has additionally been impacting our business significantly.

The accustomed bearings charcoal activating and has acutely bound our predictability. And as it is currently absurd to apprehend how connected and how acerb the communicable will affect the economy, no reliable appraisal or added absolute altitude of the specific implications for sales, antithesis can be fabricated for the 2020 banking year at this point in time.

For this reason, our adeptness to anticipation is decidedly broken at this time. In our antecedent annual for 2020, we had affected a 25% access in acquirement compared to the antecedent year and operating costs are about at the aforementioned akin as in the antecedent year. However, the furnishings of the coronavirus communicable may advance to a cogent aberration from antecedent projections and to a apparent abatement in sales compared to antecedent affairs and possibly alike compared to the antecedent banking year.

The advancing bargain acquirement will additionally accept a abrogating appulse on the advantage and clamminess of Biofrontera in the 2020 banking year, as the abridgement of acquirement may not be absolutely annual by bulk abridgement measures. At the aforementioned time, the bulk abridgement measures already accomplished in March ’20 will continue. These measures accommodate in particular, the addition of short-time assignment in Germany and commensurable measures in Spain and the UK, the abridgement of the workforce in the United States by about 20%, and binding contributed leave for all advisers in the US.

Steps to defended clamminess and strengthen banknote flows accept accustomed the accomplished priority. As you are aware, we had to abjure our action to affair convertible bonds or ADRs in the United States a few weeks ago as the basic markets went into such agitation that the adjustment became absurd in a reasonable price. As the Company requires added costs in ablaze of the afflicted bread-and-butter situation, we accept absitively that we will adduce a approved basic access of up to 20% of our allotment basic for the Anniversary Accustomed Meeting, which will be captivated on May 28.

We assurance that all our shareholders will endorse and abutment this decision. The gain from this basic access will initially be acclimated to accounts our accustomed operations, which as you apperceive accept absolutely heavily been impacted by the COVID-19 crisis. It will added be acclimated to abide costs analytic studies for the added development of Ameluz as able-bodied as for sales and business costs of Ameluz decidedly in the United States.

Long-term structural advance drivers including the acceding framework in US, the characterization extensions for Ameluz and abbreviating accepting of aurora PDT in Europe abide intact. And we will acceptable advance already the COVID-19 crisis is over.

At this point, I would like to duke over to Hermann for some closing remarks. Acknowledge you.

Hermann Lubbert — Chief Executive Officer

Yeah. Acknowledge you absolute much, Thomas. As we move into 2020, we will abide to assignment adjoin deepening the bazaar accession of Ameluz beyond the United States and Europe with added characterization amplification and bigger reimbursement. However, in the concise as the COVID-19 communicable continues to affect all-around accumulation chains, analytic trials and medical treatments, it is difficult to adumbrate or anticipation the butt of the year.

While we move through this pandemic, we will abide to apparatus a cardinal of bulk abridgement measures and attending advanced to abiding to a aeon of able advance already the bearings is resolved. Until then, we absorb our banknote and adapt the Company for a backlash in business already the markets accept recovered.

The upfront acquittal of EUR6 actor by Maruho will advice the Company to break financially defended during this aberrant crisis. We acknowledge the connected adherence of our advisers who accept afterwards barring accustomed bacon reductions until the business improves, again, as able-bodied as the abutment of our shareholders through this difficult time.

With that said, I would now like to accessible the alarm for questions.

Operator

Thank you absolute much, and we will now activate our question-and-answer session. [Operator Instructions]. And we’ve accustomed the aboriginal question, it is from Bruce Jackson of The Benchmark Company. Please go ahead, your band is now open.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Thank you. Acceptable morning. The aboriginal place, I’d like to alpha is with the banknote position, and you’re activity to be accepting the EUR6 actor acquittal from Maruho. Is that activity to be appointed in the aboriginal division or the added quarter?

Hermann Lubbert — Chief Executive Officer

That will be appointed in the added quarter. We alive the arrangement bygone and we apprehend the acquittal from Maruho aural the abutting few days.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Okay. And then, you were discussing the operating costs were originally accustomed to be collapsed over 2019. Attractive forward, we don’t accept abundant afterimage on the acquirement side, but maybe we’ve got some afterimage on the bulk ancillary of things. Area do you — area do you anticipate the costs could acreage appropriate now and what admeasurement of that is anchored costs?

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Hermann Lubbert — Chief Executive Officer

Well, we — Unfortunately, we can’t absolutely accord a advice for the butt of the accustomed banking year. However, with the bulk measures in place, we absolutely apprehend a cogent abridgement in our bulk compared to the antecedent years. Our costs are mainly apprenticed by our cadre expenses. So, force forth we — we accumulate the headcount and the advisers that we currently employ, these costs are appealing abundant fixed. If we basic to accomplish added cogent cuts in our costs that would crave layoffs and we absolutely try to abstain this if at all possible.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Okay. Aftermost catechism on the bulk side. Aftermost year we had the action expense, it was adequately active. Is that activity to be bargain in 2020 or about the aforementioned or what’s the trend for the action costs?

Hermann Lubbert — Chief Executive Officer

Well, acknowledged costs are to — the all-inclusive majority of our acknowledged costs accredit to the aegis of the DUSA litigation. And as the balloon stands now, these costs are — I don’t appetite to say bottomward to zero, but they decidedly reduced, as we are cat-and-mouse for the adjudicator to appear advanced with a plan as to how this biologic is activity to go forward. Best of the costs spent were during the analysis aeon that requires a lot of hours.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Okay. Acknowledge you for demography my questions. I’ll hop aback in queue.

Hermann Lubbert — Chief Executive Officer

Thank you, Bruce.

Operator

Thank you. The abutting catechism is from Thomas Flaten of Lake Street Basic Markets. Please go ahead, your band is now open.

Thomas Flaten — Lake Street Basic Markets — Analyst

Thank you, and acknowledgment for demography the questions. Aloof afterward up on the questions with account to cost-cutting. I anticipate you mentioned that you had a 20% abridgement activated in the US. Can you animadversion on, was that primarily on the bartering alignment or can you accommodate some blush on area those reductions took place?

Hermann Lubbert — Chief Executive Officer

They were beyond the organization, both field-based bodies as able-bodied as appointment based people.

Thomas Flaten — Lake Street Basic Markets — Analyst

And aloof switching gears, the aboriginal division sales you pre-announced on Friday, the aboriginal division numbers, which were a bit below, absolutely our expectations for area the aboriginal division could appear in, accustomed aggregate that’s activity on. Could you accommodate some blush on the arrangement of contest in the aboriginal quarter, were things proceeding to plan until the average of March aback it seems that best companies started seeing COVID appulse or can you accommodate some, aloof some annotation about how the aboriginal division acquired about to your expectations?

Thomas Schaffer — Chief Banking Officer

Yes. We can absolutely do that. So aback we went into the year, the aboriginal division was absolutely able in Europe. So best European — or all our European markets decidedly Germany was aloft — acerb aloft budget. And afresh the sales alone abutting to aught on the average of March. And still, Europe came out appealing abundant at annual added or beneath by the end of March, because it had been so able afore that.

The US bazaar hasn’t been as strong, in January, particularly, we were still seeing furnishings of some stocking that went on by the end of aftermost year due to the accustomed bulk access on January 1st. So the US went analogously boring into the year, best up in February and afresh by the alpha of March was absolutely area we accustomed US sales to be, and we anticipation it would still be a absolute able division aback this communicable absolutely happened and afresh all the offices either bankrupt bottomward or they are aggravating to abstain seeing patients in physically, in the offices.

Thomas Flaten — Lake Street Basic Markets — Analyst

So, for the sales aggregation that charcoal in place, are there activities that they’re administering either around or some added way to abide educating because I’m bold physicians are still accessible to be contacted may be alfresco of the appointment ambience obviously, but can you animadversion on any advancing bartering activities you accept activity on?

Hermann Lubbert — Chief Executive Officer

This is afresh altered amid Europe and the US, because of the altered approvals. In Europe, the aloft focus acutely appropriate now is to use some array of abroad approaches like sending belletrist or blast calls to acquaint aurora PDT and the new characterization addendum that we had. While in the US, the reps try to break in blow with the barter through the aforementioned affectionate of measures, but not so abundant with the ambition of concise diplomacy because cipher is activity to buy now, but with the ambition of advancing the advance that we apprehend already the offices can accessible again.

So best of the time, what the — what our reps do is try to break in blow with the barter as acceptable as accessible and at the aforementioned time assay the chump market, the PDT bazaar and try to accent the barter bigger decidedly with account to the antithesis amid Ameluz and Xepi and use the time that we accept now to afresh adapt for what comes afterwards this absolute affair is over.

Thomas Flaten — Lake Street Basic Markets — Analyst

And afresh one final question, bold that you’re able to accession the basic afterward approval of the May shareholders meeting. Accustomed your banknote position today, what affectionate of banknote aerodrome does that accommodate you adjoin your maybe best bourgeois models internally?

Hermann Lubbert — Chief Executive Officer

That’s never a guarantee, but in all likelihood this should be added than acceptable to accompany the Company to breakeven.

Thomas Flaten — Lake Street Basic Markets — Analyst

Excellent. Acknowledge you so abundant for demography the questions.

Hermann Lubbert — Chief Executive Officer

Thank you, Thomas.

Operator

Thank you. Afresh we’ll now booty the questions of Bruce Jackson. Your band is now open.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Hi, acknowledgment for the aftereffect questions. First, so you said that the FDA balloon advised for abscess is accessible to go and you’re accessible — you’re able to alpha the trial. Can you maybe accord us a few capacity on what that balloon is activity to attending like in agreement of the cardinal of sites, the cardinal of patients you accept to recruit, things like that?

Hermann Lubbert — Chief Executive Officer

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Yeah, certainly. So the absolute — the aboriginal balloon will be a Phase 2b balloon in which we attending at altered evolution times. So, if you recall, the action of PDT, aboriginal the biologic is activated and afresh there is an incubation, which aboriginal of all allows the alive capacity to access the beef and afresh the alive additive has to be metabolized to the actual, a light-sensitive admixture and that takes a assertive time and the best you wait, the added astute the bark eventually gets for the PDT treatment.

And so here, we will attending at altered time credibility and anatomy altered groups of 30 patients anniversary to absolutely analyze the aftereffect in these — with altered evolution times.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

So 30 patients anniversary for how abounding groups?

Hermann Lubbert — Chief Executive Officer

Three groups.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Three groups? Okay. And afresh if we could move over to Xepi, the availability of the acceding is absolutely a absolute development. One of the added questions about Xepi was the business approach allotment of it. So the dermatologists do appoint some of it, I accept there is additionally a fair bulk that is acclimated in hospitals. So how do you feel about your approach advantage for Xepi and is there a altered business activity for the artefact compared to Ameluz?

Hermann Lubbert — Chief Executive Officer

Yes, there is absolutely a altered business activity in that Ameluz is a buy-and-bill drug. So we advertise anon to the doctor and the doctor and the doctor has to buy the biologic with his claimed money and afresh try to get acceding afterwards, while Xepi is a accustomed drug, like best added drugs that are absolutely bought into the pharmacy and afresh awash out of the pharmacy if a accommodating presents with a prescription.

And here, we still accept an accessible affair with Xepi. So aback we took the artefact over, there were basically three aloft issues that we had to assignment on. One was reimbursement, and we accept been absolute acknowledged with that one, with appealing abundant 150 actor bodies now covered afterwards any restrictions and the added was an bigger and added able with account additionally to our profit, added able co-pay system, which we alien in April 1st.

And now the abutting footfall would be to afresh advance the availability in bounded pharmacies and this is a little bit of a catch-22 situation, if you advertise little, afresh the pharmacies won’t banal it. And afresh if a accommodating comes, it takes a while to absolutely get the product.

And obviously, aback we are attractive at an astute infection, the accommodating wants analysis to alpha anon and not delay a day or two for the artefact to access and this is currently bridged with a sample that we accord to the doctors, but that is a solution, which we achievement is acting and with growing sales, we can absolutely move abroad from that and accomplish the artefact readily accessible at bounded pharmacies.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Okay. Okay, great. And afresh the aftermost catechism from me, with the branded all-encompassing activity with Maruho. What’s the abutting footfall for that project?

Hermann Lubbert — Chief Executive Officer

Well, the abutting footfall for that would be — would be analytic trial. So it would go beeline into Phase II and so we are absolutely attractive at bringing this into dose-finding studies.

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Okay, great. Acknowledge you absolute much.

Hermann Lubbert — Chief Executive Officer

Thank you.

Operator

Thank you. As there are no added questions, I would like to duke aback to you.

Hermann Lubbert — Chief Executive Officer

Well, afresh I would like to acknowledge you all afresh for the time that you took to participate in this blast appointment and the absorption in Biofrontera and ambition you a absolute nice day. Acknowledge you.

Thomas Schaffer — Chief Banking Officer

Yeah. Acknowledge you absolute abundant and break advantageous everyone.

Operator

[Operator Closing Remarks].

Duration: 46 minutes

Pamela Keck — Investor Relations

Hermann Lubbert — Chief Executive Officer

Thomas Schaffer — Chief Banking Officer

Bruce D. Jackson — Benchmark Company, LLC — Analyst

Thomas Flaten — Lake Street Basic Markets — Analyst

More BFRA analysis

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