Earnings call transcript Q2 2023

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Operator

Good afternoon, and welcome to the Cumberland Pharmaceuticals' Second Quarter 2023 Company Update and Financial Report. This call is being recorded at Cumberland's request and will be archived on the company's website for one year from today's date.

I would now like to turn it over to Molly Aggas, Account Supervisor at The Dalton Agency, who handles Cumberland's Communication. Molly, please go ahead.

Molly Aggas

Hello, everyone. afternoon. Good today's joining call. for Thanks this issued the quarter press XXXX. announcing Cumberland financial Earlier ending results XX, second a company's the and release for afternoon, operational June update found related tables, the www.cumberlandpharma.com. includes which website at release, can The be on Cumberland's financial

an overall Company an and financial results also update, partners. brands, pipeline including a of during management overview those call. today's will They'll its share company provide discussion of

Cumberland's Hamm, Chief Organizational in Financial Executive Todd Participating A.J. today's President, John are Anthony, Development; Kazimi, and Chief call Officer. Vice Officer;

international Please mind statements in their those company's Act. the the downturns, including results, with made call may as could and company's concerning forward-looking statements and discussions public defined by reflect control. caption, economic are risks disasters, There Form during described any Reform natural involve expectations current today's SEC. uncertainties. statements factors. that keep health Any affect Securities updates future are Cumberland's Risk as that Cumberland's XX-K in may factors are Those include epidemics, events views and are future others well additional under in qualified that forward-looking beyond the risk Factors, Those and the conflicts issues the filed Private as many

for only. best today Despite to future any Please on so forward-looking the remember or this of due differ the actual information updating efforts, new the of a materially result that company's is shared current statements, considered call may results from developments. responsible not as information expectations, whether could as company be

on on website for sites links Full will each references can websites, and those prescribing information the safety at marketed the be there Cumberland's product several brands. be call, found corporate today's individual During brand www.cumberlandpharma.com. the is included to and to

respect performance. was earnings found can to tables The also explanation with earlier the reconciliation to financial today. measures in issued the release provide some An that be GAAP and its company financial measures will non-GAAP of

them hold At be the questions, until call. the we'll end any to which have please point, you If happy them. of answer

Cumberland's Kazimi. call the With that A.J. to I'll turn over Executive Chief Officer, overview,

A.J. Kazimi

Thank everyone. you, Molly, and good afternoon,

you we'll us how appreciate as as taking the financial call, of the gone. today's provide do our We a time We'll review to update of the both quarter for today. year first On well results company the of share the has half XXXX. join second

let's So get started.

the advance pleased to the slowly half and operating year. to been that quarter the from our quarter overall the the as challenges this pandemic continued second the quarter, and up $XX.X an up year quarter. first second million, for second last to Revenues successful of I'm our post-pandemic report environment In team the same and sequentially were worked facing. XX% first over business we've period from year improve X% diligently

a continued down row, in second were improve quarter. XX% expenses the for quarter to our the margin gross for to Operating and

We of also from and adjusted earnings $X.X quarter, million year. half delivered first the flow positive earnings for cash during growing the the operations second of consecutive

product. It's since business launched sales newly Sancuso contributing first it transdermal joined to has and to were quarter. the positive there help developments been oncology June, our the last to Moreover, our support their during patch expanded chemotherapy patients year. In FDA-approved portfolio our prescription oncology division tolerate we treatments our many

the products completing a also new to We're transfer facility. of the manufactured

package the now of the year. second there product for supplies FDA of to planning the Following half site, first over be we're that Cumberland approval manufactured of

of to for in approved expanded infants RediTrex Meanwhile, May, labeling age. the the as our of completed. formulation of Pharma an its transition July Nordic intravenously largely delivered months six include product, Caldolor to use FDA is three now of X, In ibuprofen to

newborn safety and infants. announced of results study in those positive Journal in from investigating Drugs of in a the clinical publication And Pediatric the we Caldolor June, the pharmacokinetics

this non-opioid we department reminder, products eligible XXXX for an act surgical manage requires special more favorable during used the approved it to reimbursement legislation. separate or a center. outpatient Medicare ambulatory reimbursement earlier pain in surgeries to and be regarding That and As new in conducted was believe NOPAIN in Caldolor, under year for starting an Medicaid will provide hospital

idiopathic receptor Touching to FDA that unmet of clinical ifetroban our lung patients Investigational a FIGHTING next interstitial Drug May, programs, the fibrosis, needs. and on a progressive series Phase a forward common to for We soon. studies selective with trial cleared New with ifetroban, continuing launching potent FIBROSIS pulmonary to most the medical we're of sponsor in In Application evaluate study in thromboxane fibrosing disease. the X antagonist patients form look

X late we study results form in additionally, patients Phase closed the data in the aspirin-exacerbated to Dystrophy we Phase our we asthma, to severe its respiratory approval. of Phase presented Muscular with plan clinical towards and Project path patients on the DMD all study an Parent from product of a from and results update Duchenne on our And X June. completed of that X programs disease, known was in before FIGHT at analysis Muscular as the develop await further decide Dystrophy these best And Conference with the annual

statutory ifetroban we a refunds second waiver quarter, those to studies. could used based those FDA FDA previously after granted as that did on funds better did $X approximately innovation fees bring of programs, each to that waiver concluding We it in the Cumberland in prescription clinical associated of receive the development million advance second June. be that our the with the meet The both criteria drug paid. refunds the granted informed During had barrier-to-innovation Cumberland the total had that would us

quarter. on further performance our highlights Turning some during next the financial to second

the the this year mentioned, were million, X% and XX% prior $XX.X of net revenues I up over As quarter over year. period up first

from product our the continues two benefiting the partners. its were It's the during sales and year over largest the XX% support performance on our York selling Taking and from addition a to formulary at co-promotion period quarter. the second also look brand. New our up prior Kristalose product be Medicaid

are improve We're to Vibativ catalysts significant our new in that Vibativ as over efforts a were working their product's year, performance. with sales further markets, and rebounding, have number register international several launch up initiatives partners provide future should to the for which they and brand's do underway last XX% we in of also growth.

ordinate that Caldolor of associated up of our available only with been has reimbursement to partner. And brand's sales so were that's the deductions And year. due were transition. X% of four Sancuso also will by to co-promotion look the loss part that is Sancuso of this the major we that amount Medicare become special an future. that far and rebates forward and sales mentioned the returns I brands underperformed impacted our in

us we ahead, recently now. I to co-promotion looking mentioned partner, we largely And are deductions sales our But behind replace expanded oncology sales our believe those division.

Anthony, Organizational with Todd? So our Development, our discuss to Vice Todd I'd brands. President, that to further team overview turn Cumberland's like to now, and

Todd Anthony

you, Thank A.J.

We support comprised FDA-approved national divisions. that's of of separate portfolio our medicines sales three through a organization

on Our while office-based physicians. sales institutional key our the country, field accounts hospital division across group calls covers select

our our better to During our oncology the second tolerate patients, Sancuso, we them deliver cancer brand, quarter, treatments. their newest to sales efforts division to chemotherapy helping to expanded increase

complicated hospital-acquired an with well designed our now. update certain offer skin ventilator-associated I'll each antibiotic as infections. product, injectable Vibativ, major potent or infections, on start treat pneumonia I'd serious like of as to including to our brands bacterial

marketing life-saving with sales new on We to of continue potentially this strategies that to Vibativ's work sales performance improving updated increase initiatives feature awareness and important brand.

During to to quarter, see of these response new Vibativ efforts. the we in were second pleased sales the growing

Kristalose. to next Moving

of laxative, packaged strength in four taste-free ounces Our prescription premeasured and quickly a very dose clear powder that for grid-free solution. water dissolves a in just convenient

We largest support continue selling co-promotion continues and product. well through our to force successful to partnerships, be field as our Kristalose it as sales two

that We where states have in the brand found have coverage. Medicaid we best performs

increase implementing of York added initiative believe formulary, sales New coverage increased in our to and the is special this are voice We we of product. its presence that to share contributing state. Medicaid recently a new the that and to Kristalose

Caldolor, that which approved may the of product for The months We our approved May, through delivered include Turning labeling, administered is labeling for FDA fever. in of expanded of treatment to injectable an we is infants. now in With newly now use product approved for that's ibuprofen pain -- nonnarcotic announced treatment pain to its and now the three the in patients only this fever injection. Caldolor in now age. young as non-opioid the to infants and pain as the be agent treat

patients. the patients. Acetaminophen Other products meloxicam, established those injection like class, in for not and not or as safety is children of pediatric efficacy also drugs for approved been pediatric age the not not years in for in as have less treating use approved are children ketorolac treating for drug of the two that than established been has in of pain safety those and efficacy pain

pharmacokinetics demonstrates therapeutic the mentioned, the treatment infants. treatment evidence in has growing results Caldolor require safe drug of Caldolor clinical six investigating fever. pain which one children. positive a from of for option who the The months safety evaluated Caldolor shared A.J. a As between and study and in of in study exposure The XX of and clinical the safety already infants hospitalized profile the newborn ages we June, the in that Drugs, the journal, infants and in is were the of pain and to for or body study, practitioners available of results published Pediatric fever supports

new be will non-opioids special Medicare addiction mentioned, in or also legislation. the under we A.J. eligible NOPAIN prevent As reimbursement the Caldolor nation for believe

We act into early guidelines scheduled expect the XXXX, Caldolor CMS XXXX. to and in itself the effect to in is reimbursement for go issue

transition and as States. as support distribution, commercial full Shifting taken the includes Kirin successfully national now of the the from have well its to in Cumberland this completed promotion We responsibility its And medical the Sancuso marketing, activities. Sancuso. its Kyowa for to United brand

the Late be last a source facility, to will the future moving product the supplies. products year, manufacturer which FDA new of approved

rights we prefilled As Nordic that license for provided us for U.S. product the Pharma, line. who product with our line of syringes, recall the with our for previously that amended RediTrex, agreement have

July of product responsibility has this Nordic assumed the the of As U.S. X for in year,

physicians XXX,XXX result, marketing issued $X as also Nordic returned and refunded reimburse as to We the has the RediTrex a launched have transferred credit we group and of in well RediTrex we had for approximately FDA in As the previously quickly milestone to They provided. new authorization provided fees. million needed a payment have office-based for a Nordic. the accessing U.S. note we shares issued the insurance $XXX,XXX in faced securing difficulties $X coverage. us million market and

continued While RediTrex not volume did investment grow, the brand. our in the did justify prescriptions

currently previously, As from new management, the issues. and ownership of new Omeclamox-Pak suspended facility is reported supply and availability we operations. packager supply we're their their to That brand operations a due our awaiting now for under potential

alternatives other restart exploring the packaging. product's also are We to

Additionally, Vaprisol product. manufacturer our we're for transitioning to a new

the plant for resuming We have found approval shipments. and are before new a facility FDA awaiting

partner Our for prepare is interim to issues supply the manufacturing new them special compounded of XXX manner. product a several FDA we critically-ill and are warning letter working Meanwhile, Form in address to working with timely patients. with a

Well, that update today. completes my for

So I'll back it to you, A.J. turn

A.J. Kazimi

you, Todd. thank Well,

an we activities. like Before the on report, turn I'd international to update to financial our provide

their Middle introduce in manufacturing in the updating Mexico. Tabuk international they the register second several information for the support quarter. Arabia approval Pharmaceuticals with approval submission during their of to countries our continue Pharmaceuticals partners preparing is We into new that the their in efforts is product Caldolor Saudi thereby to brands plan in as East. to PiSA of

the And who's our Korea to regulatory approval inquiries country. as to submitted also in now for market, distributing the their Vibativ approval for of Vibativ our in country. has for the Pharm, in partner Caldolor, South Vibativ SciClone there Pharmaceuticals, seek partner they continued respond their has Chinese DB

launch those of and of four the We initiatives, to approval our in countries. these the look we products are awaiting forward

With to results. that like review turn I'd Hamm, international update, it John second to our John? quarter Financial over Chief Officer, now to our financial

John Hamm

you, A.J. Thank

for continuing XXXX, by quarter from $X.X sequentially for and second XXXX $X.X Vibativ, XX, XXXX. the Caldolor. the product for for For increase $X.X million, an XX% Kristalose, were included the Net $XX.X prior operations three X% June and million ended $X.X year first revenue for Sancuso period from of million million the months over million net of of revenue quarter

note Therefore, an for amount unusual revenue of to an annual like believe product's continue is impacted I'd transition. that the to quarter evaluated that on Sancuso net basis. deductions our was associated we by the best performance with

$XX.X were product Year-to-date, for Kristalose, $X.X revenues for million $X.X and for for $X million revenue net million $X.X year-to-date Sancuso Vibativ, Caldolor. million totaled Total million.

outstanding the secure associated Vibativ million settled We $X also milestone favorably initiated to payments product. our litigation with we in

As result, which the a million, other received the as was we revenue $X recorded second during quarter.

expenses when for the were Net And quarter $X.X quarter Total a resulting $X.XX was share. compared to $XX.X improved expenditures. totaled second earnings year Both earnings or a period. were over and $X.X adjusted the The adjusted our million million. for expenses are expenses prior million. for share. to added $XX.X earnings $XX.X Turning or operating year-to-date have million $X the last income noncash year. the adjusted back, million million significantly the income were $X.XX Year-to-date net

please the quarter. of Vibativ the adjusted $X.X flow do goods total additional Also, benefit of so and benefit from Sancuso Year-to-date, cash the include earnings $X.X points note during of not as $XXX,XXX. was inventory That the for of that received acquisition, calculations million. the operations million cost is part was each product's the

to impacted product statements reminder, have portfolio. significantly been our Vibativ addition a financial our the and As by Sancuso of

inventory, new assets $X upon of subsequent in payment. $XX a and transaction added, milestone As of million $XX a Vibativ The acquisition, the assets and financial approximately the terms Vibativ million total goodwill. for included payment million a million a in result $X million intangible million $XX was including $XX of closing of

We provide product to also royalties continue tied sales. to

XXXX, our value was added investment. Vibativ has that since the $XX our approximately million largest total of contribution The continued million in $X million and delivered including assumed business end those cash estimated was second a million in million million a new $XX of therefore, assets, I'm in the inventory $XX the of of $XX return Sancuso at a of intangibles. quarter. late assets report it has to to and acquisition, on responsibility $XX we generating pleased our for product total and

million to We on provided provided total will return acquisition. brand contribution already we Since cash at royalties and pay has $XX.X it a based approximately There also of that on early last shipping started sales. for closing begin Sancuso investment. the the our we are initial believe product a $XX.X the soon million $XX.X we Sancuso million, generate year,

access a help the in million. $XX.X balance acquisition. the million to second capital, continue bank quarter, and the reducing We which that provides at loan. credit, to And of Sancuso fund was this the hold it of been we line $XX to up line of We've end

during Both in $X quarter. income with paid recorded as of waivers other refunds FDA the associated were FDA quarters. the and were second their The by million refunds first during fees the second

equity cash million. and million total cash assets, As million equivalents. including XX, of totaled was June XXXX, $XX.X $XX.X $XX.X million in Liabilities we had in $XX.X and total shareholders'

on we Also those with our as restricted continued repurchase total well second open share during shares. buying market These the fund of a XXXX, shares. needed XX,XXX program, quarter associated the of the repurchases included to taxes as those employee-vested

continuing will to members are for XXXX to like that in tax the carryforwards. over continues Cumberland new trading to Cumberland our net in plans note establishing of $XX the holdings who I'd company. their shares process purchase hold million loss Board over operating We also increase

financial our to completes that for Back And A.J. quarter second report of you, the XXXX.

A.J. Kazimi

you, Thank John.

the of the growth We're and Kristalose recent in business. successful our in our a half particularly So been first Vibativ overall, year. by it's encouraged

been has see in safe growing been it's the to it of the infants. has now all ages, pain, treatment a evidence steady, that of nearly body that's performance in Caldolor's fever, demonstrating including option therapeutic good While for

We're further maximize also to with encouraged We'll about pursuing the medical finally, of help our commercial as the And to acquisitions. opportunity continue the and therapeutic progressing our with ifetroban we're also division our strategy pipeline brands, seeking oncology the progress our and clinical we expansion to sales our cancer of select patients. unmet progress by solutions needs. excited studies for continue potential

please Now to the Operator, call let's open questions. proceed. any

Operator

we company's any questions. the that will presentation, Ladies and gentlemen, for the now open Instructions]. and [Operator call concludes

A.J. Kazimi

call We a we'll you today's do call. to and reach prefer joining you happy discussion. for so, private of And with everyone many and discussion that understand a a management. please thanks, such with to be just if Well, out us, scheduled hold get

in providing the always, time As in another interest your we update appreciate forward and to look we your and coming months. Cumberland,

Operator

Ladies and gentlemen, you, today's concludes Thank call. sir. that

to your a for I you section would to like website. visit please like would replay thank participation. on the you listen the Investor of Cumberland's to If Relations discussion,

may You disconnect. now

Cumberland Pharmaceuticals (CPIX) 8 Aug 232023 Q2 Earnings call transcript