Earnings call transcript Q2 2023

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Operator

Good morning, ladies and gentlemen and welcome to the Fennec Pharmaceuticals Second Quarter 2023 Earnings and Corporate Update Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded.

Now, I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.

Robert Andrade

Thank you, operator and good morning, everyone.

We are delighted that you could join us today for Fennec Pharmaceuticals' second quarter 2023 earnings conference call.

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

appointed Adrian Joining Rosty Executive newly Raykov, from our Operating me Fennec Chief Officer; this and Haigh. morning is Chief Officer, our

Before that during made will these call, in periodic press that in forward-looking remind differ this with actual to are subject the I Reference risks we and forward-looking and discussed detail that the and company's Commission. from Securities statements Exchange filings today's results may to and would cause begin, making the to risks you like be in the are company and results uncertainties event disclosed the release U.S. uncertainties statements. in to current

this of as only revise obligation our disclaim on statements. In of to call views represent today specifically or should upon relied addition, subsequent as any representing be our any any update not as views statements We and forward-looking forward-looking date. any made

is being that, I rebroadcast available call XX with And conference it on days. Raykov. for now the This turn be Rosty where www.fennecpharma.com, recorded over will this will call website, next Fennec's audio to for

Rostislav Raykov

discuss efforts achieved the for our of Robert everyone. in Europe. significant you, morning, we global underway the is to We'll including our many call and past opportunities, the today's over have launch be PEDMARK progress on Thank milestones several ongoing good months. as the focus discussing recent and recent The updates U.S. approval review in

this to call. quarter all release in financial earnings of prior results, which we this issued outlined Further, our detail our were press second will morning

young of risk reduce with pediatric loss month in age patients, cisplatin-induced solid availability and only older As a reminder, hearing is PEDMARK FDA-approved of in long-term of rigorously non-metastatic The increase awaiting of and therapy of critical life tumors. option one community to is localized first was the and the pediatric PEDMARK oncology tested quality safely the patients. the breakthrough a potential these which for a FDA-approved ushered enthusiastically to

the we only patients in European announced hearing one June, includes by and is Further, marketing protection. the Pedmarqsi Authorization, solid in years years market month authorization plus non-metastatic loss prevention induced therapy was with chemotherapy Commission. tumors. In Marketing Pedmarqsi EU age Use for of of the Pedmarqsi, first years PUMA was cisplatin by granted data localized granted Pediatric XX eight to of which two and approved

agent of underscore of following: as on focused believe executing our when potential results remain rapid prescribing pediatric as a cisplatin-based responses ensuring oncology strategy, a the barriers child access PEDMARK premier to choice the we're solid with We therapy complement Minimizing the we among questions share PEDMARK. terms In and non-metastatic establishing the quarter the establishing pleased product and community. necessary of for they commercial to the Fennec partner localized as to the growth second of tumor.

these offering patient comprehensive To we both address product and patients PEDMARK support. access best-in-class source HEARS established have single a services program to goals, to and is a called connect financial help designed Fennec which patient support

strong with institutions a cisplatin hospital pediatric approximately of U.S. access of including commercial team that launch team and use. a NCI centers, out marketing, In built and COG, PEDMARK the XX% the XXX to highly addition, is we have targeting on that NCCN drive U.S. execute focused sales distribution, across

approvals including PEDMARK we double-digit larger pleased Further, accounts. third consistent in growth orders academic centers from More pediatric the centers. the major specifically, had recent in we're quarter's formulary and prescribing new quarter hospital repeat with centers, hospital success the at early second have in existing pediatric

we regional most have More of coming recognized centers excellence. both academic recently, major early practices. and a the of adoption pediatric from reminder, from As adoption has had come centers some

encouraging highly HCPs seen have have over seen target accounts within time. adoption Geographically, all territories are our of PEDMARK our prescribing increasing that we and

terms In have tumors. process, broad osteosarcoma of prescribed patients. given tumor several in have securing in and including our hepatoblastoma, across been we successful for seen terms reimbursement utilization and Further, we streamlined types, coverage patient favorable of patients, payer coverage

the June PEDMARK Pedmarqsi. and Pedmarqsi market. will pleased confident we're for the this of is to We're within building area be in significant Union which become expanding the marketed treatment share in that be growth net to approach disciplined the execution launch we So approval revenue announced in the With XX% in our and will plans strategic the second against unmet U.S. Europe, regard marketing European to to effort the and execute team address evident of and only starting in quarter. as to authorization continuing need. first targeted experienced the medical are our in

significant continue to Europe the shareholder a Europe the create it partner for evaluate best or either rest pathway the We both, company commercial value. opportunity pathway of in to another alone and go with or select, see we we as world; whatever

major am very to Adrian and join as the of of XXXX success management Adrian a I Officer. today, announced pleased Fennec's to has he is part joining as since Finally, family. from have contributor Board Operating been executive Fennec team Haigh the Chief Fennec the

the fortunate are have available us at commercial to this evolution him of We pivotal help in to stage Fennec.

President last Officer Adrian Khalid and Islam Dr. role for affairs to with where us where from Gentium, development, and was medical for a was Chief his built of of worked responsible Pharmaceuticals and commercial pivotal Senior that, and at PTC Head Gentium Chairman, our business International. playing billion. Prior to to also Jazz comes the he sale organization Vice Gentium's as in Adrian managed $X role Therapeutics, Operating

this great Adrian, given of overview Fennec a you opportunity see Can you on for to you brief the call. new with us give your role? have it’s us

Adrian Haigh

Operating to Rosty. full join have delighted Chief Thanks, to Officer. I'm been Fennec time as asked

ensure our of all aware, quite ride XX PEDMARK. at focused many the caused patients chemotherapy access risk hearing to end commercial cancer to left year international PTC that everything, last of across leading you laser and has been building less eight of years the at mission As through last organization. years. have role are after remained over the I a this pediatric But we on by cisplatin the

for not was commercial my that same sales, that I'm global significant the evaluating needs in teams strategic me options Fennec and Board while delighted generating Retirement at all that experience the right set time, post-approval in leading pre- the believes now. skill is and

a submitted for doing that Europe the with preparation, place For HTA example, enabled we a significant in same the fact combined value generate be in pre-launch Fennec at are key us revenue with the shareholders; at Gentium, commercial small team across dossier considerable had that all priority. to will

have needs to and direction and we take. speedy done approval, launch, work be ensure to done ultimately successful quickly we Now EU that a strategic whatever

Of course, PEDMARK equally in United the of important is States. accelerating adoption

progress is of the last need by months. all protocols included be considerable we a made standard two we've said, the and approval treatment Rosty will ensuring quarter my of as be key number that reviews priorities. still These these in but care Concluding PEDMARK coming pharmacy As will committees. over in critical

further So our call, member will to forward full where be once real on pleasure a next team it's again, provide we a and the look time updates to progress. I executive

for results call that, now Robert our With quarter. to over the to the financial turn review I'll

Robert Andrade

Thank you, Adrian.

of quarter today XXXX of for our those results. through the Our our can some the Rather results my second comments be on will press which all contains key read release financial website. of details, details Media on Investors viewed focus of than section financial &

XXXX XX%. The of XXXX second in million of of million revenue for first product the a net company the recorded net sales growth in $X.X $X.X quarter versus of quarter

remuneration. the the $X.X recent first with approvals pleased the are we PEDMARK early to compares healthcare $X.X second QX. growing in mentioned, have G&A non-cash of formulary Rosty was hospital for the to within which access million during providers As And acceptance XXXX million attributable largely quarter. increase we of XXXX. is with gained The the quarter of quarter in second employee

its and expense it The is are costs reduced when negligible inventory The research PEDMARK. company traditional as R&D of with and recorded second and and advertising, distribution quarter associated began and expenses million research expenses company approval in an expenses expanded now company capitalized and the $X.X PEDMARK marketing recorded of include marketing Selling shipping include $X.X or and compared XXXX, selling first FDA to expenses majority commissions sales. into recorded The logistics, of the quarter cost and insurance, force. development of in the to expenses. when selling internal recording eventually payroll out-of-pocket product of million marketing in wages, received XXXX. sales costs, development to

$X.XX of was million XXXX GAAP for or GAAP million a share per $X.X of the $X.X net Our compared per share. loss or to second $X.XX loss quarter net

the investment $XX second cash, securities. second convertible And finally, quarter with debt million approximately capital drawn under of cash in equivalents ended We existing $XX cash our the includes facility. This and Petrichor position. quarter million in our

was million of quarter to cash $X.X Our in second burn XXXX. approximately million the compared the quarter for first $X.X

reminder, million As $X we at a take capital the least next believe anticipate with operating assumptions cash XXXX. PEDMARK out months. coupled expenses XX during in revenue us when our for We available approximately will monthly

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

Operator

first the Knickerbocker Chase from comes Craig-Hallum. Our of Instructions] question [Operator of line

Chase Knickerbocker

accounts to about, is the Maybe what accounts We're for putting finer of would do I point are six accounts. have just committees account just today there? on be to however, general a the those helpful now about nine that it. the you of investors. you month Of larger takes just growth. Good think concerning at. think on And, to point hear focus period you those P&T number talk finer to penetration your a define the ramp get tail at to it, XXX cleared accounts, want there P&T of Maybe we

Rostislav Raykov

have number -- Rosty. in quite is were Chase, this time from significant the accounts. to where details we what of say would last giving moment What quarter. shying compared away We're of this I is actually at we that terms is at

remarks, the was in accounts is in prepared with growth As I this prescribing mentioned and my accounts. -- double-digit

had most that, in to pediatric P&C wins oncology. have In the recognized some of major larger addition and in institutions some we

through will So ahead these significant would are this still hopefully, us, help coming up. And more coming as P&T committees that of further there growth. accounts really opportunity quarter. with But double-digit we again, some of have be a

Chase Knickerbocker

speak customers? having cisplatin Maybe you on any ongoing shortages that's hearing Do think the U.S. in to What you impact ramp it. your from point? seeing this Got we're are at the

Rostislav Raykov

shortages pediatric cisplatin last has the the that that that an issue heard least -- have been have we about at for ongoing been has been not four No, oncology. months not in

with -- -- know, begin many as nedaplatin goes the half of in those actually shortages at -- you are patients moment not hearing cisplatin. We about pediatrics, we're there not a lot to and the cisplatin [ph] but first. is As those to

Chase Knickerbocker

through large a Adrian be the discussions bringing playing Got implication role? here And and of role in -- it's Adrian in partnership this there? alone thinking Or maybe an kind we it. to it obviously you out the cementing now in is Adrian is on then building thus experience PTC Europe is should the a appetite COO be in about there, good has that how there. we launching capabilities Europe international just there Is been increased their be fit would and role thinking his businesses should from those guys go

Rostislav Raykov

now. our have We Fennec personally for prepared known very, small at And we a in members. were remarks. Yes, with our years we work very closely Board Adrian over company, XX

And in this moment. I'm to he us that was very, so join very able thankful pivotal

up he access see ground of the for opportunities, Europe, to above. the medical to help with overseeing his This and in in resume, U.S. globally partnering organization has all goes Europe As all experience above. you sales us from or both the launch from of set affairs and helping necessary to the the could

well. may Adrian, as So say couple a you to want of maybe, things

Adrian Haigh

lot add. not really a Yes, to

I how is experience know minimal it commercial that and do if do my be to it how at this. third the to organization I've that done to this the how it. quickly do think I build cost. I time know I've -- do will we to I know

Rosty earlier in to involved of on the As ultimately Gentium, business Gentium in said in heavily sale development at and I Jazz. was the remarks, prepared

earlier, person the me sense of last role. boxes. right the And right getting at say, the take months the retirement there member and have helping over I very in kind I for full-time of board honestly, been I with as on we agreed was a quite the said actively And Fennec I I'd and as quite couple think on to makes all all a Board Board So time. believes tick engaged

Chase Knickerbocker

that lot of a sense. Yes, makes

How your Just back should launch a the investors kind thinking last own or for guys. Any how queue, launch a with partner? or we update there? it's in about me on in of and I'll not potential should on be Europe, hop whether about timing be thinking

Adrian Haigh

options. Well, I all think evaluating we're

But happen, have of launch to enable the be towards think lot to do next of year. end the that to a first quarter work. will I a we

a called of that Germany For requires of in no lot the Germany way that example, license has for anybody and by in there's a preparation. in submitted that special in you have be to isn't apply [indiscernible] November. quite to place, end license XXXX If can hospitals in that sell then

We HTA dossiers as all work preparing And It doesn't you for several the key have the know, takes also overnight. started that months. the happen countries.

So speedy doing it's kind most the it's possible. when it's through that whether ensure or is it whether whatever partnership, we're through takes to Fennec of successful some launched, PEDMARK launch a

Operator

David Securities. Our next Nierengarten from the of of Wedbush question comes line

David Nierengarten

markets. I just the a on the of couple kind had of penetration

have been childhood are know, repeat your many of dosing coverage utilize centers centers how I centers, centers, is it patients? any rare is as And have But there of academic or -- have repeated occurrence. XX%, been there do there then XX%, Like a an you have patients thankfully, the on percentage? on estimate XX%? First, are that cancers those

Rostislav Raykov

yes. David,

the second answer look the first. so you it at varies. So Yes, overall, one centers maybe I can if

have physicians it. of half some So they're are repeat centers where physicians utilizing where where utilizing are There most the it. -- customer orders, you utilizing centers the are

seeing it from because that here results, their drug really comfort-by-comfort sort So physician-to-physician, seeing on this our types perspective, both into from and several plays experience varies. the label into of tumor It's months disease-by-disease, mean, are a but only patients launch. an from course, the perspective efficacy outstanding and we're and growth I of safety putting almost importantly, comes we scripts, nine product, center-by-center, writing

been report A which hasn't how there And good is. speaks to drug an this

product you that As oncology in that see for anything has or oncology that that. pediatric matter any rarely would --

have because So that's really, excited we treatment what good makes for a us kids. very, these very really

Sorry, what was the first question, again?

David Nierengarten

customers. academic of centers first was treat they of up The population. number on as actually that was of in total repeat the the of out the typically the I the -- of question percentage patients year or the centers think kind number next one academic signed the and

XX%, is majority So yes.

Rostislav Raykov

distributed. the launch early it's be centers typically like Maybe, have -- you it's said, on granularity the hospitals -- pretty well the which it's academic Yes, of and numbers well Robert, some adopters. between these some I but it's pretty some of smaller pretty to more early in distributed tend

Robert Andrade

and we David, add, major Every what to academic I'll said. formulary unique they sense it similar said the after on recently. roll what formulary already, of how some Yes. patients, is center type to approval. of have the or Rosty philosophy centers out in sees before approval the amount of their Similar we patient whether gained

anticipating And some so, excited that quite and we're orders about there.

in months go more applicability. patient learn as we our terms all the hopefully, numbers, PEDMARK So out, actually centers from of

Operator

I session. question-and-answer our Raykov. now Rosty concludes the to This you. back would conference to like Thank turn

Rostislav Raykov

us the joining updating quarterly on We progress launch future a you and in you morning. continued and great our Thank corporate thank for look I have you to all milestones would today. to calls. like forward

Operator

today's for you concludes call. This conference participating. Thank

may disconnect. You now

Fennec Pharmaceuticals (FENC) 3 Aug 232023 Q2 Earnings call transcript