AMPH - Earnings call transcript Q2 2021 | Amphastar Pharmaceuticals, Inc.

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Operator

Greetings, and welcome to the Amphastar Pharmaceuticals' Second Quarter Earnings Call. [Operator Instructions]. All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance, backlog, sales and marketing of our products, market size and growth, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates.

Our share buyback program and other future events, such as the impact of COVID-19 pandemic, including its variance and related responses of business and governments to the pandemic on our operations and personnel and on commercial activity and demand across our business operations and results of operations. These statements are not facts, but rather are based on Amphastar's historical performance and our current expectations, estimates and projections regarding our business operations and other similar related factors. they used might, intend, would, and forward-looking plan, or expressions may, potential, anticipate, other assumptions and contain statements because that as Amphastar's or to should predict, forward-looking related expect, are some forward-looking you unknown cases, control. and these words, place continue, undue project, are difficult known such these will, on risks, not in beyond reliance not should, could, statements predict, involve uncertainties and similar statements, Words although identify all to believe, impossible estimate in Actual on a forward-looking the year results on March may those with differ SEC materially XX, factors, Commission, December of ended and as from described of report filed those including result Securities XX-K Amphastar's with annual the filings the XX, the Form a for including XXXX, in statements XXXX. number Exchange our In and response including to time. particular, on taken remain COVID-XX's pandemic, including depend and of as in well businesses factors, the by of which on all this of the evolve will uncertain business actions governments, extent and impact our the at variance as extent consumers severity, to the duration several continue its pandemic,

subsequent our is referenced to to in future, update website information our release. that Amphastar the speak being undertakes statements note SEC's statements or becomes http://ir.amphastar.com new in in or release these circumstances of call events or the conference expectations You forward-looking only of information -- or reflect even these events any conference reports cause press recorded. this as www.sec.gov. no The Please the if can above locate to through and the this change. this or release at if on at website forward-looking call the revise available date obligation

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

Dan Dischner

and Earlier, financial you, with all you joining for our strong reported this growth. afternoon. Thank results operator, thank us Amphastar

the for characterize our Q&A is of financial and the further Peters, on the myself. we'll our Senior to with Clinical President and another progress. to Finance. our results. with Bill Bill's in call With and Tony as Bill President After company's period financials. seeing Regulatory of As today Starting an move of Executive provide pipeline Amphastar's update, I'd Vice pipeline, Affairs Marrs, second me Operations, commercial He Vice our and portion like quarter update CFO will

saw company's revenues expense and The seeing a savings. second legal increase. income quarter an increased XX% as XX% The last strong our year-over-year quarter saw onetime to net $X.X net million, from $XXX.X million, of increase remained considerable

naloxone enoxaparin in of While play these in some products as downward some these one saw few to of we being pressure we of products, the products term that our Amphastar this committed believe we the believe and our ability strength of emphasizes the to call meet platform sourcing, terms favor quality. end, vertically API that the our resilience continuously for chain which needs, demands. due reliable to supply in manufacturers our will quarter, and U.S.-based the that market integrated To remain long meets quality

the we growth year. represents the remains And given quarter, in grew reasonable a strong, remaining that sales achieving Looking to sales in are $XX.X to This share for last half of increase to well positioned at driver, price. reasonable a based line IQVIA, sales for at newest Glucagon growth expectations sales compared with be our market on our Glucagon a million believe second quarter. XX% durable of the

same quarter for weekly channels million COVID-XX's annualized Mist, X% and our independent marketing We provided end and stronger digital of of last efforts our period distribution by marketing a guidance previous Moreover, last We that seeing physician the of is Mist sales an our with impact. have believe sales base Primatene's been highlighting build have quarter. program success TV from efforts the from each of increase the that our trend, and radio in-store upward Primatene increased thus a remain this seeing to year, increase sales continued Primatene of our year. weekly other. launched complemented upon a Regarding XX% sampling $XX

challenging a While component the to the believe in will program the to are to grow crucial quantify, we further for Primatene sampling program be provide future. results support

company The momentum. pipeline. some upward our toward Moving saw

amounting can Two quarter our facilities. of zero as be second one those saw total, in quarter and best to a quality at characterized of routine items, were U.S. highlighting inspections systems. our strength manufacturing inspections The X of of the FDA XXX each

to The revealed was pre-approval third was for for a generic XXX, injection. inspection be which XX AMP teriparatide

in the date as has year. a to IQVIA. As it product quarter annual has market received in on now giving responded commercialization approval. Again, plus no a approved approach teriparatide With for $XXX based this a fully a receive announced for track filed respect CRL June we to to other to taken to. on we have has we the generics the a AMP-XXX, from legal result, perspective, this continues ANDA million ANDAs, which soon Moreover, that been our as and us a conservative path fourth GDUFA best be

determination We are make GDUFA final waiting the to -- date. the on FDA for

and product complex are a a is no of. As aware filers this generics product other we that no with reminder,

still the have IQVIA, quarter the As for is of date first next $XX million a AMP plus in based year. XXX, to a GDUFA market annual anticipated on ANDA

a intranasal products, continues proprietary progressing to XXXX program remains year. other stability filing in quarter product's with intranasal the an in our proprietary expectation the clinical of subject fourth refile as on progress. further the this our naloxone, track epinephrine is To product On to the for studies in its of product,

approved, recently on version we was an differentiates believe While X-milligram our market. we from others product understand that the

generic was the like believe insulin our interchangeable first a noninfringement insulins. AMP recently this It and biosimilar we year. strong Amphastar's interchangeable insulin not to changed is positions. Paragraph while I'd that close, regarding be Regarding pathway this has regadenoson XXX later on AMP XXX still filed is To program. IV track holds our other There remark for to strategy. validates biosimilar our our plans approved, filings,

life We into behind enoxaparin continue to results. robust. to and believe turn we existing market At now performance that attainable give insulin will the with matures for same to biosimilars cycles, Considering Bill can pipeline technological discuss the support our injectable longer I our remain namely to complex that like already from the platforms and on would time, Glucagon, this those inhalation generics our profitable. focusing second development most see products. Peters projects as clear, product recently, further call by and hyaluronidase, demonstrated and the and financial the quarter details pathway

William Peters

for to the a million. Thank million growth sales has million the as a the during modest to second Enoxaparin $XXX.X at $X.X quarter. first market $XX.X $X.X Glucagon, to increased of quarter XX% Mist strong sales million XX% of decline reentered million million with Primatene increased grew the market reasonable launched a from you, showed the once to in the the Sales reasonable multi-dose in sales $X already million the from quarter sales year. previous Dan. to with Epinephrine strong of to million from saw again due $XX.X growth second up price compared led competitor with XX% sales last $X.X $XX.X declined quarter, the share sales achieved $XX.X second million. year, which vials. we to Naloxone and competition.

related an $X.X from of in million, $X.X million business revenues MannKind. fee the received due Our timing to up of sales shipments insulin and the from year, API amendment primarily prior had $X.X of million to

recognize will this to end $XXX,XXX related of the additional revenue We through amendment of quarter XXXX. per

of share loss in the onetime $X.XX provided impairments amortization, $X.XX net share of XXXX television share of $XX inhalation income an $XX.X million million, adjusted $X.XX from a including sales distribution including of launched products. TV the compensation, have expenses and in new repayments. we million Research to the Board ads, we lawsuit and General cash with associated lowering net marketing the margins the $XX.X of the last million our announced quarter the from the second Adjusted our $X.X second million, million as XX% Nonoperating additional to Today, which gross of was quarter company average. The buyback of and in $XX.X quarter the from associated or radio our to Primatene slightly of the second marketing onetime because per quarter flow attributable in equity to quarter former in to million in quarter increased program, per quarter million million XX% long-lived $X.X increased and in the shareholders stock have products company exclude of past, we to litigation to from our $X.X income commercial. or we quarter assets an or last Aventis, $XX.X in from authorized the the and the airing during of second income per reported margins of this net year. the accrual plan to events. year. of the million Mist, recognized $XX.X our to In than compared end due of income in quarter same $X.XX cost year last we million reported development year. XXXX. costs multi-dose or decreased that increased primarily in utilize this develop share quarter, Selling, expenses and the for of with with Glucagon increasing as of primarily second sales made second per we repurchased and to separation As $X $XX.X with compared $XXX,XXX XXXX We national higher corporate $X.X of million operations in net million. the second $X $X.X insulin vials adjusted gain settled with million executive Amphastar associated at debt We administrative $X.X showed which trend continue earnings this years, epinephrine agreement by The the the last discussed proof our million future. last an and expenditures to year. spending with few

facility with million call over entered a We also back loan debt a term help used consisting million to business. $XX credit. line existing of rates. lower debt flexibility We expense and I Q&A. begin expand believe as turn operator and ensure the we us interest the financial our will grow this now $XX higher approximately interest will to of to $XX We million $XXX term into revolving off loan and million a we've the that pay of facility, announced

Operator

[Operator Instructions].

Tim Our first from Northland question comes Capital. Chiang with

Timothy Chiang

AMP-XXX, product? time terms you expect to do for approval generics guys the around gain of year market multiple in On this that same later formation

Dan Dischner

but of say would a I'd to I side-turn while. a It's say, for no. complex been probably the to unchallenged answer product it's that's hard

So we this with anticipate not many product. too competitors

Timothy Chiang

in have product get right? assuming approval, And this capacity you the launch guys fourth enough quarter, that will to is you the

Dan Dischner

Yes.

product that made So we will years installed built of and actually, ago. lines be filling one the of this on couple a

So this expansion Amphastar we of our that headquarters. is part have the at

we're go this ready So one. to with

Timothy Chiang

a guess, Have set AMP already or product. osteoporosis a that for I have another you date XXX, mean injectable -- Paragraph do I you But And that's no? that's IV. court

William Peters

dates we date don't because the that date want to the that we for are the we the list is team a Paragraph item. Paragraph don't gating on have set GDUFA ones IVs impression the by court believe is do that. I GDUFA that to the make reason the constrained -- And

January date for have set do court a So of we that's XXXX.

Timothy Chiang

financial on? this you've Okay. I revolver. that just you question. and bring pursuing some would last some taken of have interest business guess financial you I question. flexibility, additional loan It's obviously, I have in a more you in to debt the with potentially bigger took now any products term development Maybe one but mean, mean, some

Dan Dischner

of that we reason refinance existing to debt. the debt part the Well, did is the

and paid pay to some directly down the we loan $XX went of quarter, $X So new term million during existing the the million debt of debt. of off

bit reduction more the little that of a X half months So past has that. $XX over been than million, so

buying Additionally, spent $XX we of a had ANP. million portion back

to having of our that sheet the funding the some large that So debt that. to couple agreement, we're capital filed years. does our -- for be keep will on and expenditures also a acquisitions, have put with within cashback wanted And for balance buyback acquisitions, that to acquisitions do some with add it do say those we though. The will program be in easier XX-Q permitted November, in if next attractive but the allow we which revolver change that and if borrow think that to attitude need see I line framework. our flexibility company. place place, certain we this will find acquisitions, But -- we in in and well and make this towards we some that, wouldn't fit some

Operator

Instructions]. [Operator

question be from Piper Amsellem Our will next with Sandler. David

Zachary Sachar

is This strong on another Congrats for David. Zach quarter. on

So well far. chain the so getting you've done just for large obviously, product retail Primatene Mist, into the

And So do just smaller make there other large retail you this targeting are wondering of more in focusing just DTC, retail on plan other if terms and then any point? you're chains this channels are Or investments just now? that at product? marketing you for what to

Dan Dischner

there. looking partnerships hit at But most of of think think smaller I retail we've the right hit analyzing stores, we've major Primatene, now, most I retail points. the major maybe With different and distribution Yes. retail. We're

Zachary Sachar

the of was second question? the part What

Dan Dischner

Yes.

second the what And product. dealt, is our have would I marketing say consumers of that aware right the asthma making mild question of the the think think focus is that part who I just sure with are the So more of we it. now

be we're the -- to spending all people there in product product be sure to there. we're make is that think But everyone in this making we're that I and successful that we retail the to still because out know aware have outlets to So are well that don't grow. money need

is. So that's focus what main our

Zachary Sachar

squeeze on Okay. I Great. in And follow-up then could if one just epinephrine.

in you footprint -- you what do as institutional market sort is this kind envision have think could Or do of role wondering it a to of retail going like this mainly be product? Just some well... for

Dan Dischner

spray, nasal intranasal? The

Zachary Sachar

epinephrine The Yes. nasal product.

Dan Dischner

what's presentation to Well, different I product currently the a than think it adds there.

looking be potential pen we'd the product. for at this So that market market, as a

a is primarily EpiPen retail-oriented do just primarily -- like we we'll be this itself. the So product, --

William Peters

opportunity any is of don't there'll ease it. use takeaway Yes. will for use think And key I for channel it think just I for the Maybe the created be new it. the

that's think that. I primarily key the to

Operator

Elliot Our comes James. from next question Raymond Wilbur with

Elliot Wilbur

AMP-XXX. on Questions

commentary, there with connection prepared there XXX or that your in to a It whether were clear in for wasn't not was mentioned Dan, preapproval So a that that. you issued PAI inspection me -- inspection.

for lead this to half that in just period. then trends. about could question you active. XXX, Obviously, follow-up naturally numbers an that contains this of clarify of a the just gross to then auto-injector number mix, And move outside the on So benefited as Bill favorable margin on just pure if that. But mix is, that might you can to device a kind confirm think question addition anything in that of quick fact, second in And filing the lower? a year

Dan Dischner

we've or events. us and primarily were of as As the consequence the it system some far as the of fully any were There really of anything that PAI a good characterized quality that XXs inspection, inspection. with addressed were issued. They them. related we've to dealt didn't certain have all timing It

that XX we response raised. that our will the of believe they've issues all address So

goes, As last trends yes, And year. pen with I question the half your autopen. second is and as far an gross it the the in of the the dealt margins think

we've price some significantly, price potential will couple of So cost be hold for increases increases some of pretty gone positive do our relatively for that But we've had. in offset some California raise that some are the a think wages increases the up it has of We company. have we labor those -- had for mainly on to here. we Cost have the and think maybe should to past. we where was products pricing opportunities even do in that

to on has we average still basis and or of our lot heparin the continued heparin have up go costs, and crude of based for and price we product time that acquisition channel. lead cost the in a cost long a Additionally, very

used -- price can So actually we next source down prices in for while to that of to the up like seen the the more look until of going we come have go of have couple average that we they're more goods forward will future, cost our to down. is continue quarters product hit in

Operator

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

Serge Belanger

for talk -- on still and product XXXX to your year? of Glucagon. the remainder Can you million expect $XX million XXXX? the the First this one you outlook And just about to do competitive generate $XX

Dan Dischner

Yes.

Glucagon, with don't now. is competitors other second product, year. part this -- seen I next often think had ones. first into product haven't any with it sold was the it a We that the complex was being we We way been a time, the -- it's or -- the we're challenged way And the potential this hadn't outlook for that time. at were long marketing

I the think same. see we more of

reason is is current good no time. as different any be believe now. run as it we that for We to far can some have We the than would tell that rate think it quite

Serge Belanger

Okay. on confidence On of get AMP-XXX, level your obviously, a the review cycle? complex product. first if What's you approval

Dan Dischner

I'll let answer Tony that...

Tony Marrs

pleasant like a products, have agency. the the that complex it surprise that to from What products with learned definitely is and approved all surprise We've a it. say it. would for be also positioned can other have I we we're for Well, filed complex

time that So these every I file contents of application of meet requirements of think the one predecessor. its applications the we

the the evolve, in them filing with as requirements we're agency keeping of up our So those for applications.

we would for the more that we But for the do think home a certainly So success. higher are these, But chance it. run I for poised of again, it we be have us.

correspondence encouraging cautious I the -- the just moving are as our I is agency. think And but speed optimism. it's that at think things far with as

Operator

question next Steinberg David with from comes Our Jefferies.

David Steinberg

million job competitor? nice there'll see that "durable". until you half the Conference at of do that of Are as $XX.X XXX, should in Healthcare you've increases? A you saw then comment On another therefore, year And done the made you I implying QX, a to you sequential the CRL you the product you the QX couple be and June launching said Or actually and no second being, secondly, day a increases be sequential from early think, really questions. then the product. million QX it on to in the a there's of got $XX the And glucagon, time.

your hadn't You submitted response.

XXX. year You early since time, other you discussions thought FDA October at still may date at that GDUFA with for you the your the in thinking? next had then. were looking have either But or Is

Dan Dischner

first, We think take is run -- and we're I'll that million. Glucagon the pretty So the a safe a run $XX.X rate, that question that's pretty rate. fair

we model at So that's what point. would this

Tony Marrs

far make the be to scenario we're AMP in year as would as you for that. we We've what As believe you're later XXX, early based and a of the best-case either be submitted will the waiting yes, right. final best-case determination on agency scenario the that, XXXX. or And said, this

Operator

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

Dan Dischner

I for and want QX results with today. thank us future. time We and our you QX. for on an to those look today having again update to forward sharing Thank you everybody your give quarter good another allowing joining to you us for in the

Operator

conference. today's concludes This

You at time. evening. a have disconnect your you and wonderful may for this Thank participation, your lines

Amphastar Pharmaceuticals (AMPH) 10 Aug 212021 Q2 Earnings call transcript