JAGX - Earnings call transcript Q4 2019

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Operator

Good day and welcome to the Jaguar Health Investor Call. Today's conference is being recorded.

Before I turn the call over to management, I’d like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of products, the impacts of competitive products and pricing, industry trends and product and technology initiatives, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements.

Forward-looking statements are subjects to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management’s current assumptions, expectations and projections about future events.

these its currently and cautioned available place reliance that in are not believes undue of view information, on management assumption, projections expectations reasonable to While statements. forward-looking you are

other Except call Xrd, its SEC Health forward-looking ending are results Form by future and in actual update April with XX-K filings the which contained was including from presentation in of differ section Jaguar statements The December to Risk this which for available in Factors the filed information, relations company's variety the events Investor to or may or of on a forward-looking described company's year new revise undertakes XX, and those XXXX, law, for materially XXXX as discussed the otherwise. this the statements those no obligation of Jaguar's any reasons, website. required reflect sections

be business. as and its management measures GAAP. financial basis non-GAAP presented operates the company non-GAAP statements basis and condensed measures for of company's financial please these superior non-GAAP should and isolation provide substitutes loss with the or and EBITDA non-GAAP providing Additionally by net believes performance disclosure recurring EBITDA. items conformity substitutes to GAAP of with in reflects the assesses measures financial information supplement not for which GAAP the sales note, in viewed or These that that consolidated upon additional net Jaguar GAAP gross investors are not a on sales,

the and Lisa it's Chief turn Conte, President Health over floor time, call yours. to to pleasure my this is At Executive Officer. Lisa, Jaguar’s the

Lisa Conte

interchangeably very on joining Jaguar and subsidiary CEO names thank who I are much. Napo wholly-owned much My and Lisa use call. call Pharmaceuticals. of Conte. Thank you today. Founder you. the you very Health throughout Napo Jaguar are the this is name And and may for I'm Thank our all the phone,

report at my Q&A doing and through are warmest as taking - we everyone that [ph] we would such this be understand today. course, of to home wishes as fine. all stoked remotely everyone and not call navigate Jaguar times, Jaguar at unprecedented grateful these I First, we all to We're Napo feel

company allow for years. over XX well been us Third working work been of when years. for trusted XX has us the to Three of familiarity working XX together together continuity and to together over That remotely. even have

[ph] Now we literally other's doing the finished each sentences.

natural successfully XX We and mission we middle in first under botanical a HIV from we in harvest brought plant-based years were the and guidance FDA. needs. medicines Mytesi oral to the prescription tree to pandemic meet global urgent medicines only another on that to the resource, Amazon of the Rainforest approved a find were by responsibly ago Napo plant-based we AIDS for health

find of of we Mytesi the for to pandemic, middle appropriate relief in FDA COVID-XX. ourselves symptomatic Today emergency determine if the may authorization in for COVID-XX use with the working patients with diarrhea be

at million the nearly people of XXXX. therapy, data [indiscernible] end use antiretroviral on HIV million XX Nearly based and XX June from with globally people

As with patients a in currently therapy. HIV the class being first antiretroviral symptomatic is FDA of in agent, for diarrhea of reminder, indication a non-infectious adult relief anti-secretory on Mytesi approved

living Mytesi, Mytesi uninterrupted taken steps with an have to we’ve on ensure have prescription rely HIV medicine. and We anticipated to and its of of product oral essential with topped up Class this essential access first patients [ph] where an A who kind business that

functional diarrhea’s which Other cancer Crohn's bowel include therapy the bowel as related actively gastrointestinal care, in advanced pipeline. products inflammatory irritable a pediatric indications refer is We're potential indications most and indication, multiple to the follow-on disease and before said potential rare we disease developing on CTD. the we pipeline syndrome, diarrhea, indication. focused as Mytesi [ph] GI [ph] GI supportive being

There [indiscernible] speakers activities. with company an from I'll today’s call, for a update the begin be related five participating are and development covering on five our speaker. ongoing COVID-XX with topics provide business status efforts primary we'll update regarding

Next diarrhea, VP of Lizak, Officer, Ian recap our will provide the over Senior enhanced Finance and Napo's turn we’ll facets for for currently Ian, time. for Strategy. Carol approved of a real to Carol related Commercial to Vice discussion an of indications we’re Mytesi and in HIV recurring quite initiative access the our excited Accounting comparison discuss after I'll death strategy XXXX, multiple XXXX which financials market is of about will Chief Wendt, who President introduce the

of potentially He that pathogenic in support currently [ph] program the world medicine moving Science Dr. played funding and is also will of information Diseases approved in has Allergy support of Steven development [ph] leader Institute National from the Cholera program Infectious Cholera forward. traditional [ph] our Chief the of fight and King, global provide project discuss recently scourges against the regarding Ethnobotanical playing our and the also would

indications diarrheal And our finally Chief bowel syndrome. the regulatory pediatric will short Crofelemer disorder to developments Officer in potential Dr. speak potential for rare the and CTD to indication disease Scientific related Chaturvedi, Pravin for congenital

right in. jump Let's

we forward, believe and Jaguar be Looking a Napo. has year XXXX transformative to potential the for

pivotal the of Mytesi the the crisis. of goals related access diarrhea strategy for rollout market XXXX HIV which especially enhanced strategy company's part core this during CTD our Our in health for time therapy support of of with this include to global is of patients larger the trial year half cancer the completing and initiating second

majority with AIDS are of States living United people The in HIV the older.

access ASS-AIDS access not out first is resilient non-profit The As we community from Lisa. organization pointed patient pandemic recently, our Mytesi as and Kick Tez HIV hear Napo is plan more Ian. our believe Syndrome enhanced Survivor we'll its founder the patients to me help expand which about the Anderson, of will Let's among

growth commercial in supports by the our primarily Mytesi stable, to sustainable positive company's base this business become model, strategy a effort sales. Key supported business business flows cash to

or a development on deal I business confident clinical we as initiation and possibly mid we’ll are forge one development than Mytesi. ex-U.S. dilutive activities, dollars key more non the pivotal XXXX bring pipeline in indication the follow and stated Simultaneously before for to regional support trial by to that

is Napo business development, pipeline for pipeline driven development at business that pipeline, by development, [indiscernible] mobilization. pipeline, business

have We I pipeline within risk a a mitigated enough, – pipeline say a important contains indications one product, product and number that can't Mytesi. remarkable novel which multiple for

proof safety indications Mytesi product indications are is commercial for Let a me and that already in GMP strong supported drug manufacturing on the or FDA concept place data. II Phase package, by several for and a for remind you by approved the chronic chronic follow is Mytesi therefore of of and

supportive value of potential a large funding will The patient non-dilutive world for pipeline and care provide indications solutions partner believe world. around long provides term the disease we for across opportunities populations for fuel investors creation pipeline our and the this multiple depth around collaborations

mucosa, secretory secretion herceptin inhibitors standard efforts. continues focus receptor herceptin diarrhea. of I pipeline experience of to as therapy the epidermal agents and significant am targeted development to for tyrosine leading chloride A chemotherapy therapy to without inhibitors, undergoing activate example sorry, – be natural kinase Diarrhea kinase related patients antibodies, treatment such factor cancer our may potentially the in core cancer anyway, portion with diarrhea. agents gastrointestinal pathways tyrosine Novel cancer or

endoscopy DID, is CTD issue the and [ph] patients. most appearing Diarrhea and April reported in chemotherapy this According events of common for with XXXX stands component treatment to was gastroenterology of news. induced adverse in guidelines a in data chemotherapy the which diarrhea,

or lethargy constipation the Diarrhea opioids and reductions therapy. this dose potential OTC Imodium, in dehydration, diarrhea population causes life holiday the has which is and their Loperamide cancer cause with many saving [ph] [ph] patient to patients [indiscernible] drug in agents require cancer and

for management cancer. therapeutic And relevant of allows for better animal term as allows adjuvant therapy. treatments potentially better cancer patients long patients in on for and outcomes for Better potentially of it for we've better shown diarrhea with targeted models, leading compliance the cancer clinical dosing - in particular

Han, of FDA of Woodcock, and the to field Center continue Janet Drug our XX, authorization a Dr. to Stephen request epidemiologist. in an of accompanied submitted March for to one efforts diseases To to a we and leader care on of request submitted was CC Director emergency COVID-XX, Dr. from infectious letter endorsement Research Mytesi on FDA The for and XXXX. Commissioner make use the available related by in Evaluation supportive world based mentioned,

been letter is symptoms. based endorsement real information adequate of time has information is indicates prior are there the The gastrointestinal and reviewing pulmonary symptoms which to on that that leaders other early and diarrhea with of COVID-XX key symptoms document opinion publications to

sequel that store review potentially less only is and via the [ph] reduce risk here of support dependence be the all group care changing blood [ph] data to volumes from the thus from consistency providers. people shed of [indiscernible] [ph] could also key Mytesi health by not the virus supports This mechanism and the the action transmissible the decreasing results watery would but also of to contagion deformed patients can

we've the As expect to potential FDA us get this in use with to heard of days respect label to from off back Mytesi. they

request this to many to potentially to contagion possible supports a We’re so of that role a grateful chaos time taken during for patients Napo proud the perseverance and have to address And healthcare stakeholders reduce seeking FDA's in and in COVID-XX initiative provide attention meaningful patients the release a play and to pleased to have among workers. the and we're of pandemic.

the filed move core XXXX and Investor to along course XXXX major viewed on section its Xrd result. on the the Friday, now Relations Back company XX-K be with of XX-KL SECs to SEC, our the business, the April The on we’ll website. of can the website Jaguar financial

Senior year Accounting Carol? to to Carol now December financial over XXst XXXX. Lizak, review topline Vice turn Jaguar’s the Chief for results call I'll President the and ended Officer

Carol Lizak

financial Mytesi of you, XX% $X.X in our prescription the today. over total year and to XX, follows, million, year an sales volume XXXX XXXX increased Lisa. all XX% for year-over-year. the net The highlights call thank in increase are for XXXX. year as Mytesi joining XXXX you Key December ended were the And Thank approximately

the to due of The year XXX,XXX million of was XXXX, the in primarily to for goodwill offset intangible expense operating expenses the $XX.X settlement assets year of the agreement. $X of decrease year by and total million XXXX, year-over-year. of in or total license royalty $X.X impairment compared a long-lived X%, the was in XXX,XXX an XXXX operating million the The $XX.X for million as decrease write-off

level discussion Wendt. high the of Ian my XXXX. to I’ll hand recap now over speaker, for financials our concludes next That

Ian Wendt

Good all. morning,

the anti-retroviral week, Napo adult As FDA the relief non-infectious prescription patient for our living program of drug Lisa comments opening last in diarrhea approved with in announced NapoCares on HIV expanding for company's support therapy. Mytesi, the and symptomatic her stated patients indicated as is company plant-based

HIV are which to is on the and persistency. diarrhea uptake program access, healthy NapoCares the Enteropathy, HIV the to to patients. of changes due indirect intended direct many HIV or positive for patient chronic by tract its problem GI The effects a increase has

Unlike is not products new certain only become diarrhea constipation. causing and of a unique living are very have Mytesi for antidiarrheal has its ensure for patients does helps the use approved a HIV action on that non-opiate risk Mytesi mechanism with and chronic is for adult anti-retroviral use, acute to normal of approved that low derivative therapy.

field team's Mytesi issues remain also payer access alleviating related patients with physicians non-government focused channel. already burdens increasing reducing my who better on on Our supported writing while primarily in patients are duration appropriate, therapy in and on faced of efforts HIV Mytesi by the cost prescriptions, clinically Mytesi

insured increases for co-pay prescription became Mytesi. income significantly fills a or to amounts the expansions drug day co-pay to the and NapoCares on patient support the patients whether changes effective eligible free remain of These on limits a XX same patients program Napo’s Xst. The commercially program, day raises for April uninsured XX allows

significantly which assistance offers to which income out-of-pocket NapoCares access offering the has two insured the involves increased from to uninsured times free for a a Mytesi Limit the an patient $XXX,XXX, from an market increase. maximum for a XXX% of patients obtaining five reduce of commercially patients amount to co-pay Mytesi the component increased as limit US. of for drugs patients Federal key for barrier expanded in program Limit, eligible to A support $XXXX the costs The increase. program XXX% Federal times is Poverty has the benefit Poverty annual In

Mytesi their eligible now dollars patients Most pay more for will no than $XX prescription.

patients days. their cards can they use XX refill now earlier every prescriptions if co-pay Additionally, and Mytesi

a provide a to patients program be lapse and challenges, Fast-start available prescriptions Mytesi have patients immediate soon to facing will for insurance access be coverage. reimbursement bridge soon for drug available in who will

comprehensive AssistRx patients – patient implement support support with patient to To is providers, in patients support to and a dispensing design with for with prior Florida-based access from services the working appeals authorization services Mytesi, reimbursements Napo assistance and program.

and leading AssistRx to experience therapy platform supporting streamline developed iAssist industry called extensive has HIV initiation. has patients an technology

specialty significantly appropriate offer outcomes. the access market engagement optimal help in patient model of number also pharmacy drugs new use strategy high Our in to Mytesi designed of pharmacies of involved increase such Mytesi’s is a Specialty distribution. to ensure patient

COVID-XX our who fact The expanded the the that especially health jobs pandemic have crisis. insurance may support patient lost patients during should is benefit during launching Mytesi or program

to help social patients for distancing we've ensure access still are Mytesi their medication. employ the instituted We barriers changes good should patients practices removing can while obtaining and

is a condition crisis. remove income patients and national Mytesi for as ART all Diarrhea for level, especially who patients as this in to regardless well during need chronic, HIV of their our life-altering on access goal it's their provider,

you. to my That turn Steve, for discussion over now concludes today. comments I'll the

Steven King

to those this Supply, Ethnobotanical the Property and to officer thanks to Research Intellectual Jaguar Ian for Steven make phone and My you, Sustainable Thank morning. time King, name the of I'm you us on join Chief and Napo. for

Napo of growth I'm crofelemer, begin, Xst, Napo’s [ph] received on and report for to candidate Infectious Diseases additional the from products of services informed Allergy the happy indication. [indiscernible] April To week cholera a development that last Institute National support to preclinical was

suite XX-day of Institutes of of NIAID-funded part services, preclinical National contractors conduct study. is a toxicology NIAID for will NIAID's Under testing the Health. rat

preclinical under contractors these services suite previously of XX testing and As day dog conducted NIAID’s rat toxicology announced, for study. NIAID-funded

US affect Centers XXX,XXX of acute Health an infection. same as crofelemer million with test we X the cholera Disease [indiscernible] occurs Prevention to Vibrio as [ph] refer the acting and the each cost and Human Advanced of Department mechanism cholera caused X to year is has cholerae. due less to which According death around intestine of Control [ph] after than the related the Lechlemer, dehydration hours the world. in - estimated cases Services, the Cholera itself X and to to an first [ph] bacterium knock infection by is more and to SB-XXX diarrhoeal for cholera also of XX produce.

data crofelemer and Center treatment on Dhaka, We for of Bangladesh. the have II cholera presented on in International Phase from Disease diarrhea the Research previously patients in renowned devastating

of using design the study for Under to sites the same the Lechlemer. investigator, same plan Bangladesh permitted, development and follow principal following the we same the clinical protocol, trial Lechlemer using in same for

indication. review FDA the to FDA port receive we the a efforts are and an developers this Early granted diseases drug rare believed vouchers makes review Additionally, to candidate drug by to develop neglected priority as pediatric from voucher for cholera diseases. incentive treatment for

no to are needs. that you aware, prescription be Napo’s plant-based to of possibly harvested and dating can is be many urgent mission develop novel effective safe and But founding doubt company’s back discover medicines healthcare global to

[indiscernible] therapy patients Rainforest a drug of has the America.. active use disease diarrhea anti-retroviral in ingredient extracted was indicated lechleri. maximum approved the symptomatic of and Amazon the purified business people of history Croton crofelemer, in For South the FDA for Mytesi non-opiate and of subscription our non-infectious tree and those with and in HIV living rich

result great COVID-XX one At related time of a deal the changed world information that the a based to media present another ago. global long there's that a pandemic medicine of plant as

inflammation the world new The and medicine Ecuador Bolivia. Quinine, to royal explore originally to pain. and beginning of digestive a [ph] Quinine been develop Quinidine increase allowed the used uncontrolled out and was Quinine by is spasm. the almost approved secret sona people treat, results I'm to XXth as by regions [ph] to XXX that [ph] the U.S. petro Amazon referring the treatment [indiscernible] and the discovered [indiscernible] documented. We problems came efficient the cardiac of bulk acrossa [ph] [indiscernible] century. To that in after of a Quinine devastated as have are years nations first explore quinidine malaria. still disorders, and effectiveness drug muscle of

World COVID-XX. the to safe be focusing before lupus War used of new to that will practice chloroquine and of and these used these and but Quinine methods percent and to I The of remembering drugs COVID-XX, hydroxychloroquine prove effective anticipated medical developed as part of rheumatoid and medical treat also the XXXX malaria today medical knowledge therapeutics additional now [ph] after use arthritis prevent on not for and potential There if and clear are between derivative activin combat recent treat research It's [indiscernible] or believe it's to and derivatives another is discovery Quinine, synthetic were Chloroquine to and has and XXXX people disease II. derivative worth an to medicine. the

all empire, investment I'm has in a and also [indiscernible] Lisa possible and they medicine that that follow maturing reason historical fact of be and Mytesi intertial than Quinine. developments of of before commitment won't the a once With and proud and multiple more for we leveraging another huge reportedly proud based wise additional as expect declared so was commercializing product to once at is the footnote it XXX doctors interesting terms pipeline aware traditional and In by Mytesi medicine, traditional the mind up that recently very called employed current the I'm in conserving Napo's the made with indications. medical fact being its developed knowledge. [indiscernible] again years

to Pravin, you. on

Pravin Chaturvedi

the Steve. is joining. morning, for Napo Officer [indiscernible] of everybody. Scientific Chaturvedi Chief I Pravin as Advisory Napo Good the also My serve you, Pharmaceuticals Chair Scientific Thanks am Board Thank name of and and

refer we bowel in of I planning the As a syndrome, preclinical therapy Crofelemer two cancer gastrointestinal for pediatiric of the to in adult [ph] and refer short treatment of a initiation also trials indication orphan [indiscernible] target prevention XXXX, and cancer related second Lisa BTP to FDA. Napo as is CTD or half mentioned of indication for trial patient, earlier, pivotal

is statistical with and with and CTD the an FDA trial opinion active adult the plan. and key received their the study analysis input on there we have discussion For clinical leaders

protocol their the getting after to We are on requisite and consent other and documents input the plans based including revising clinical requirement. accommodate statistical analysis the

We IND. in trial [indiscernible] under investigator The the adult initiating CTD new pivotal a CTD States. principal trial the for the United

Our the are Pharmaceuticals treatment on endpoint enrolment practicality also medical Napo both that the but ensuring the goal to mechanism of action. are design, that we patient physiological crofelemer of that is unmet CTD. trial need of [indiscernible] with agree ensure FDA to from Combined the the relevant and satisfaction and protocols the for unique

study pivotal risk Mytesi with we of and – strategy part as planned successful trial use as commercialized for to analogous and Our same currently a intend for dosing the CTD's Mytesi. our mitigation formulation the

In addition as to to with coordinating of the treatment to been we've Broad Association are We design, supporting strategy opinion for Mass management trial clinical with Multinational efforts some guidelines cancer set our leaders Care, patient. working on also the [ph] the key refers and diarrhea of and Cancer the

for sponsor June level all at the at Mass to which this year. conference be are We held Spain in was

However for this it been has at postponed time. obvious reasons

we of and However, to Mass team continue requisite the leadership provide work the support. will with

the we through the While pandemic. of all work challenges global

in with the disorders, pre-IND bowl addressing congenital diarrhea diarrheal bowl pediatric pre-IND planned provide XX children orphan We’ve either outlined the input syndrome short to it the as syndrome in the the expect This of with or as and treating reduce FDA package. we submitted requirements syndrome, from trial approximately days XX in document prepared that with to discussion rational for study their additional bowl short the Napo support diarrheal on with indication clinical revert and to FDA. clinical in [ph] For disorders. congenital the pre-IND the dossier a well we short

regions Dhabi, congenital region are leaders bowel Abu key in the conduct region. have Medical [indiscernible] us the Mohammed and Sheikh pleased who's in Center are there Khalifa to providing studies clinical North the prevalent opinion with we of and Miqdady, syndrome in guidance of believe, actually support from are diarrheal region, and the more as that short appropriate [indiscernible] region, we to in leadership where CTD, disorders SBS and Africa much

quality the central Mytesi, are reduction improve earlier, improve onset would and/or well safety these nutrional life, that of as proof of congenital planning to disorders I of to parental to [indiscernible] both [indiscernible] as we substantially as evidence mentioned well survival. patients. of CTD the pediatric improve diarrheal studies their Hence as efficacy children of clinical requirements would As provide

the – comments to Lisa. microphone to I will her you, for back Over Thank pass now closing on Lisa comments. you.

Lisa Conte

given you Phytomedicinal you therapeutic Napo’s money Research Thanks, recognition thank the Napo announce speakers Pravin. to all development of as had production E. Investment closing, Varro for listeners. proud non-profit sustainable Thank [indiscernible] the a I'm preparation, all their this of February the the we to and Commercial to Botanical American and to In has ongoing in Award past natural Tyler in XXXX to obvious reasons well. commitment Council

team successful to Napo’s which of Specifically derived we of remain approval in access mission in The lechleri expanding is in four Amazon more additional members this to key Rainforest. has the and the Steve world. throughout tree said, the committed crofelemer the for award firmly the years need as crofelemer, acknowledges some development been development all crofelemer core Croton and than of XX patients

of for recipients our clinically-tested Italian in the Dana, board botanical the one market. this Previous largest producers of partner pharmaceutical world's based extracts of [ph] include

guidance by Mytesi guide. for approved which approved and the reminder, prescription developed first generic plant-based a there's extracts only under under and can FDA’s be medicine pathway botanical is a the drug no drug oral As botanical product

situation. all with on extremely of indicators our and continue efforts partners, on address and possible the sales, of flow cash our be I'm XXXX more and grow employees, drive grateful pleased continue stakeholders key in as follow XXXX of for our and dedication stockholders Mytesi to positive and to we company achievements this all to bring support breakeven multiple in ongoing

with of living working which Anderson. conditions. the to people not to integrity proud first difference life the and time privately with with GI Ted's team high a together have also of we and in crisis. Lisa I'll words pandemic is values very be displayed This been lives I'm altering global to our make repeat grateful be a chronic very working this are

for we and has year earlier, the a As Jaguar to believe be I transformative potential Napo. said XXXX

for call. Please With safe, stay that, conclude home. you. we all today’s Thank again be you comments. once and well our Thank joining be

Operator

And conclude does conference. that your Again, you participation. tank for today's

Jaguar Health (JAGX) 6 Apr 202019 Q4 Earnings call transcript