AMPH - Earnings call transcript Q2 2022 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings and welcome to the Amphastar Pharmaceuticals Second Quarter Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. Please note that certain statements made on this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions for future periods are forward-looking statements. solely that based to now are us. statements on is information available These to entitled on the the encourage review We you section issued and website. press today Forward-Looking the company's presentation the release in Statements please performance. our and of on numerous to be a may that website, website SEC which the filings, Also, can refer impact found factors for SEC's discussion our our future

in these GAAP non-GAAP also Important information is found of discuss may use US to certain call measures. earnings note measures will Please reconciliations We our and conference release. that the be on this recorded. being

are Bill over Corporate you may will today now speakers Dischner, your Mr. Our I Corporate Communications. Dan, conference the Dan Mr. of to Dan of Dischner, President VP turn Mr. begin. host, CFO; and Communications; Mr. Peters, Vice

Dan Dischner

like diversification approvals, Thank behind We for call thank look the first the XXXX you, quarter developments. growth. the revenue joining success our half great in quarter's forward everyone regulatory our XXXX. second our We to us and specifics strides with I'd discussing of to while portfolio Paul. driving for existing earnings portfolio believe commercial made we for towards

with Bill and Vice Vice Peters, of today the Executive Operations, Senior me Affairs President Finance, CFO and and Regulatory On President of Clinical call Marrs. is Tony

open landscape. market prepared our volatile portfolio by supported for Following strongly discuss from Q&A. to and we'll changing the strength commercial our up that management, remarks I financial will first committed remains

The $XXX.X increase with a income. significant net XX% second representing XXXX, quarter QX net to increase saw revenues of compared solid million, in a

the period sales recorded [Technical baseline a in XX% Mist XXXX. products solid increase Primatene have a existing Our provided strength. solid again revenues, same representing over Difficulty]

in our for portfolio capacity in our products increased continues recorded will We for as the robust IMS IMS half competitor supporting. believe meet capacity FDA even Glucagon if asset generic strong that to only the to an Difficulty] the the remain second XXXX. demand period. our extended demand of strong revenues, Our our meet sales into remain competitors that as products product product have valued current sales. confident planned shortages for remain [Technical We the increase approved our will validating increased market demand designed a existing our remains

QX, [Technical our will forward we to look a Looking product launched sales imminent product, late quarter to Difficulty] in which as month. this we of are see the product ganirelix of excited was our And launch June. about full the

filing, a for I the will of Regarding Therefore, are like quarter. to ANDA XXXX. CRL our first which we this GDUFA the our this in AMP-XXX month. filing action bring date efforts, received We last toward to fully responded regulatory the addressable to would anticipate believe be quarter and our discussion we raised issues

receive, one not make remain without generic. AMP-XXX's is certainly to confident the have to liked While [Technical We FDA this available to to it remains commercial first with future news we work any would received CRL our inquiries as generic for possible. quarter our teriparatide, this made fourth are in the response anticipate ANDA Likewise, the quickly market year. and To filing remain June, in filing, achievable. patients and as the that we with Difficulty] we the closely prospects this we entirely confident AMP-XXX aim as filing this

and [Technical difficulty that from products it develop conducted filing, committed price traditional from products received are complex, business mid-cycle in its model with quarter. our of product inhalation to line received Difficulty] think remains ANDAs. to substantial and while point products challenging in it's highly hopes AMP-XXX two increasing our ANDA, priority of first access products. with to positive are development Amphastar's We important generics market On remain these sustainability, as insulating FDA. by I creates benefiting any with AMP-XXX's sales without positive out to these portfolio it's review life that patient our pursuit the remain remember cycles last erosion ANDA high-in-demand review filing these the approvals a this important and generic occur to that for

inspections of All our GDUFA without have that been [Technical a maintains the AMP-XXX fourth performed clinical on confidence site track for This observation. completed were Difficulty] remains date. quarter

pipeline, This AMP-XXX is our on an five of This the I'm announce announced, market in anticipated represents product. progressed by sales. IQVIA candidate two ANDAs and $X billion presentation, undisclosed, to seen updated corporate topic combined that XXXX. in another our to be over While representing inhalation as has is our our I'm pipeline inhalation filed of yet inhalation excited QX opportunity

intranasal our be for our proprietary to make on this to we which naloxone progress continue expect products As in filed month. response, we development,

local epidemic. Speaking abuse to briefly the naloxone on several combating that part we product, is to a intranasal supply community continues be continue believe opioid strategies our for healthy for and this a there and nation's with strategy, need state combined of

achieve our diabetes front all on turning see epinephrine, to potential candidate aiming our As with product finally, designation, candidates representing track plus of constructive our within pipeline regulatory the pipeline agency. studies be filed that planned. to interchangeable and discussions continue to three-pronged biosimilar to increasingly as portfolio well market and to XXXX our the the with anticipate billion an one interchangeable on be designation. for supports as We biosimilar opportunity, we encouraging in intranasal $X development landscape epinephrine several a And another insulin progress and proprietary continues positive to intranasal strategy,

willingness molecular remain launch confident remains shows our are development most and as platform, robust. purified experience, supports in-house invest the technology a an same developed proven our continue in At extensive to logical approval with full-scale We our more It which complex characterization along achieve approved peptides, the the time, sophisticated that pathways. notably R&D. pending highly we is strategy biologic interchangeable different status, achievements in and approval We API seeing scientifically products supports to FDA's provide insulin market to encouraging. generally

first in pursuing we interchangeable difficult-to-develop our product, deliberate file that our like in thought an supported is insulin challenging to remains to while plan BLA a investments Again, that and to by products, excited XXXX. it purpose reiterate pipeline AMP-XXX, self-funding. research made with and extensive for I'd are We announce

commitment we As and strategy by products as our we and high current product current supported States. an three-pronged stronghold that base that quality as as some proven further with purified complex complex our solid and long-term for our biosimilar for serve advantageous driver the We products products our support finished company our increasingly a this this continue with be foresee of enduring backed as of Likewise, volatile proprietary further remain of the seemingly and see landscapes to to commercialization all US-focused portfolio, and beneficial business produced in by continue strategy the as persist the development toward for company, for portfolio. the time, market within model United will a sustainability will candidates.

discuss commercial approvals second that Executive epinephrine have as success. remain confident turn the Vice are to approvals driving the supplemented and to to the further financial overcome. to in and details would quarter's while all seen and with the glucagon, Bill such recent like Peters, met with we we CFO results call President our were As reach this to of quarter's quarters and of give Finance, I company's on exampled in Primatene within IMS behind previous high-in-demand launches, challenges Mist, which impressive products, execution growth our being

Bill Peters

here just Dan. think because Thanks, beeping We're around. going a some second to there's pause I

can Let's solve second. we see if this a

Operator

technical Thank with deal you, for moment this patience. everyone, difficulty. One your as we

Bill Peters

very much. you Thank

$XX.X planned efforts. sales in growth. strong sales on the to marketing was second I'm of that $XX.X about last second before. million XX% from second previous at But increased that strong to Sales million, epinephrine year unit Lidocaine of to to of call. due selling sales marked million to year to Strong $XXX.X the totaling increased nearly million increased period. there. the million quarter quarter strong happened what prior $X.X $XX.X million due Primatene volume. growth last to from $XX.X compared volumes going increased with biggest the XX% to higher year's annoying average sales our million beeping quarter million back increased in unit prices. Sorry continues from increase, million $XXX.X due on sure $XX $XX.X to from year's the Phytonadione million the double exactly for Mist not $XX show to up turning

our other had shortages pharmaceutical category finished strong and such from syringe as Our launch late prefilled benefited dextrose as in ganirelix the also product growth which to sodium of as well products due June. market bicarbonate,

from insulin shipments. of primarily sales timing API $X.X $X.X to million the business Our million, of the year, had prior due down in

margins higher of including continued XXXX XX% with quarter years, discussed in in same than the epinephrine That the year. increasing quarter multi-dose of average. vials, the in corporate in margin few we've sales glucagon, launched this sales products to and second have of the the As we've last Primatene Mist, XX% our quarter gross from trend past, last

time and the Mist million, We marketing due cost of expenditures of our realizable commitments and expenses. insulin of reserved decrease to ANP or to significant and in purchase due $X.X of fluctuations opposed a $X.X million primarily of increased $XX.X the second Adjusted from of from per by year. stock to from expenses the components And impairment at net Research begin of provided a components, of million from back our China Q&A. $X.X in quarter. to also this lower used Selling, over quarter, call quarter fewer of gain are year-to-date, to our and share cash products. development $XX.X had million it income or commitment. of for associated purchases I and and the $X.X $X.XX $XX.X as expense XXXX. heparin benefit one-time the lowering per an exclude and million. distribution, the of $X.X at expenses the for $X.XX share net million. with million events. enoxaparin value last million million the $X.XX turn expenses during last In restructuring in litigation which The a cash flipped subsidiary in we which materials income or long-lived the operator $XX.X advertising in earnings to decreased will our $XX.X company was second XXXX reported with lawsuit General year per quarter share booked and to shareholders accrual $X.X a expense to Aventis, Amphastar from primarily decrease to raw to net in million of per the million freight net of a the made administrative year. an million million, second reported we year million XXXX. of in or currency last The compared income AMP-XXX quarter increased and Other increased of to attributable share adjusted $XX income of legal $XX.X the net in compared Primatene compensation, as company or due because now assets, a an to second $XX.X of repurchase income adjusted increased second operations pipeline We portion $X.X amortization, was to spending million $X.XX equity flow quarter the income for of

Operator

[Operator Instructions].

Chiang Capital is first Our from One. with question Tim

Tim Chiang

quarter? on Bill, this know you a margins is sustainable could in gross margin just follow-up you but think do it, year? talked half And question comment back XX% on the of you about this high is gross the AMP-XXX. my I

a you said think in be back half the XXXX? in plan of quarter is to from try the you to refile I do Would get year. that that next first think the of FDA? could that sometime your When response you

Bill Peters

look I one a number this instead. at the but not at at taking look rather quarter, to the six-month just is margins think better the a look way taking gross

so, gross was And our six-month XX%. margin

there heparin better the or mentioned which I that's events second way and enoxaparin in we to think because events quarter. one-time it related commitments quarter in look So, components, the the than certain were hit at higher that certain a the to first the on

the higher So, those skewed results in a a little and the second. little first lower in

goes… the think, look And to six-month at that I right as it. far your second number as is, question So, way

Dan Dischner

date. this XXXX. year respond of action We QX to an going quarter next date in with we're AMP-XXX, anticipate action an

Tim Chiang

is It a response – major or CRL, should quick right? be the it a and, I it pretty wasn't guess, major wasn't in that items

Bill Peters

Tony, you that? want to handle do

Tony Marrs

to Yes. that's It's to. not time us to something long a take going respond

as a don't that respond long Difficulty] view a time to we issue it to. complex So, quite [Technical

Operator

is Our Wilbur with James. Raymond Elliot next from question

Elliot Wilbur

for question First Bill.

program, little performance bit are you and driving baseline. know a Just epinephrine, at you're overall specifically a levels year. product, Maybe elaborate pricing individual couple strong itself question quarter, expansion you looking what that at involved of and a lidocaine, mode, they're molecule mentioned their respect or ARS, the products an recently more strength, so of a could is, just the unit just product epinephrine potentially but competitor. vis-à-vis looking of to emerged Second far is sales, Was of or of with there semi-stealth the utilization just guess, in I the has your company kind historical gaining share above to the I in all? intranasal file numbers this from, competing terms competing

helpful. on anything thoughts Just if competitor wondering competitive potential product on superior stop profile you just developing you're that you essentially so that competitive view could to the that with product your be have is you own thing. the respect from would not share would I'm as do of any that same looking a to but thinking that assuming asset, that

Bill Peters

bit very area. then, just volumes. price of the about very We product. got take epi out different And and too product. we A on products because lidocaine that But was from that we the also SKUs have but And the that quarter there's far excited a quarter. shortages of we're a about the there, the that start all dozen bit to in almost in way with little one question competitors the little the as a did Epinephrine the quarter that that and lot pricing. a of in a half sell that we due SKUs this of up product got during issues. previous some on lidocaine. we back-ordering also, been of of I'll had was that lidocaine And supplier volume. we're boost some epinephrine is confident product, of as as Lidocaine

we have I time. I'm we're else this product, works we sure that say much ARS' about want product not aware an really of to think excellent and very product their well. And

Dan Dischner

great our large ARS continue No. strategy that ours yes, product regardless of We targeting it confident just very to what a we is to continuing believe do we're a because doing. And, with execute we're and we have market. develop is

Operator

is next Belanger Company. from with question Needham Our Serge &

Serge Belanger

approval? could But this much know on talk of by about little inhalation can A around I first for more And about confidence the front PDUFA of couple haven't you maybe secondly, you complexity the it what program, design. as I can FDA, around play your probably if that guess you to opportunity since and it's questions address? GDUFA, of the get the talk your a in product details is will a this AMP-XXX. XQ maybe we first-round provided closer whether role a it market decision.

Dan Dischner

a could as closer we closer our it we vest this of when think think play get our on is the prospects to going the it, the are we opportunity think market I cards little really I marketing affect product. to because to

to do much So, we're On discuss you your on that? not Tony, of want question, more detail opportunity. around too the part second a give to your going probably market little

Tony Marrs

from has mid-cycle very, it them priority from site, the and number look Difficulty] very had agency we a we've timing the positive review inspections has and an of very aspects putting for the interaction inspections, all products meeting, a of at all positive. the product. our of of all clinical been review when the For agency of [Technical that us, it's The been exciting with

for. with be about all cycle that strive provides And of very agency our seems is well. approvals very, that little of aligned first that we're we product it course, with for Of as this we're more for combination it the to are product but nature, something interaction and complexity, and always positive a prepared a

Operator

[Operator instructions].

Piper David with Amsellem Sandler. from Our next question is

David Amsellem

few. had Just a

And first can file say the the if So, of driver on you large or that XXX, identify review, dynamics, vasopressin, is are back That's to be missed going a the is are just underlying multi-cycle Just planning two, apologize meaningful it's talk which for how just half I sales can that to Number in crowded this but that's given to competitive to you willing Paragraph IV to back to something think a market, one. year? the product? else? number brand the fairly I going a first you that, are you first-to-market limited on competition or to and in you're this, no about get there. surprise, still to just an XXX, opportunity? if but extent competition all be expecting which product, update latest thoughts quarter, you the a on be complex it wanted I no your

Dan Dischner

David, know, a own with though are this targeted, on our we API and that really product it is wasn't think vasopressin, product. making I it we a peptide as along you

yes, it's our get some you was in have I the think, I but that it question it to going the it it data On your that even about next doesn't of business us, for we behind this we're it crowded, any whether and think more could it's the And as think time. model. us. best know, at we'll or market into a – and product fit time, at crowded whether good will filing necessarily ourselves do So, AMP-XXX, IV that can but I Paragraph we disclosed product, market keep XXX% is competitive Yes, haven't for a with this fit at for and reasons. revenue

As yes, competition. remains still prepared generic mentioned for any AMP-XXX, I in as without it my remarks,

opportunity So, about still We very we're us. it. excited for it think a great still has

we the then, first looking different in quarter year month, – of action questions address generic. fourth date understandable next next do And up we'll and said, of come we anticipating an guess. year we the the XXXX. we're it the the in in quarter feel this I but for, are it's I that and them, can outcome As complex were There wasn't CRL a as

Bill Peters

just not product. a complex It's

I it's there's approval that there's is into think think first I when the not of issue has the product. do FDA to a extra pathway other work the complex around that the going clear sometimes that approval And process. a

I has it. to that So do that lot a with think

Operator

no There further like any to you. turn Thank the for at to comments. I'd closing are back time. this over floor questions management

Dan Dischner

Great. our today. joining look very it, you we We you Paul, for appreciate all updating thank quarter. us on Thanks and forward much progress next to and again,

again, you as questions, always, arrive. And if to you thank time us your those don't any have hesitate for questions today. As please contact

Operator

This concludes today's conference.

may your time. Thank at disconnect participation. this lines you You for your

Amphastar Pharmaceuticals (AMPH) 9 Aug 222022 Q2 Earnings call transcript