Earnings Labs

Adicet Bio, Inc. (ACET)

Q4 2015 Earnings Call· Fri, Sep 11, 2015

$7.79

-1.83%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.
Transcript

Operator

Operator

Welcome to the Aceto Fiscal 2015 Fourth Quarter Financial Results Conference Call. My name is John, and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note the conference is being recorded. And now, I’ll turn the call over to Jody Burfening. Jody, you may begin.

Jody Burfening

Management

Thank you, John. Good morning, everyone, and welcome to Aceto Corporation's fourth quarter fiscal 2015 conference call. With me today are Sal Guccione, President and CEO; and Doug Roth, Chief Financial Officer. Company issued its fourth quarter earnings press release yesterday after the market closed. For those of you who have not yet seen the release, a copy is available in the Investor Relations section of the company's website at www.aceto.com. Before starting the call, I'd like to remind you that today's call will contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, that can be identified by words such as believe, expect, anticipate, plans, projects, seeks and similar expressions that involve numerous risks and uncertainties. The company's actual results could differ materially from those anticipated or implied in these forward-looking statements, as a result of certain factors as set forth in the company's filings with the Securities and Exchange Commission. In addition, management will be referring to non-GAAP net income and earnings per share on today’s call. Aceto defines these non-GAAP measures as excluding all transaction costs related to acquisition. With those housekeeping items out of the way, I would now like to turn the call over to Sal. Good morning, Sal.

Sal Guccione

Management

Good morning, Jody. Thanks, Jody and good morning everyone, and thanks for joining us on Aceto's fourth quarter and full year fiscal 2015 earnings conference call. Fiscal 2015 was another successful year for Aceto both in terms of financial performance as well as in terms of continued execution of our strategic plans. During the year, we successfully completed the integration of PACK Pharmaceuticals into our Rising operations, while at the same time continued the positive momentum within our Human Health business. We established a Soft Gel delivery platform at Rising through the acquisition of three Soft Gel ANDA's from Par Pharmaceuticals, and we also expanded our Ophthalmics platform with the launches of Ofloxacin and Timolol Ophthalmic Solutions. We continued to invest in our internal product development pipeline, increasing the total number of finished dosage generic pipeline from 95 candidates last year to 107 candidates now. Regarding market position and we saw both our SIC and GICS codes change from their former more industrial classifications now to drug and healthcare related indications, which we believe probably reflect today’s Aceto. So from a strategic point of view, we are very pleased with the developments at Aceto in fiscal 2015. Regarding the numbers, our fourth quarter was the strongest profit the quarter in the company’s history, and that strong quarter gave us a record finish to a record year here in 2015, primarily driven by our growth in the Human Health segment. Compared to last year’s fourth quarter, we reported a 5% increase in sales, a 42% increase in gross profit, and 142% gain in GAAP earnings per share with GAAP EPS reaching the level of $0.46 per diluted share. On a non-GAAP basis, adjusted earnings per share were $0.48 versus $0.26 last year, so a healthy 85% increase. Looking at the full…

Doug Roth

Management

Thank you, Sal, and good morning, everyone. I'll walk you through our financial results for the fourth quarter and then for our full fiscal year. Net sales for the fourth quarter were $146.6 million, an increase of 5% from the $139.6 million reported in the fourth quarter of fiscal 2014. Gross profit was up $41.2 million, an increase of 41.8% as compared to $29 million in the fourth quarter of fiscal 2014. Gross margin for the fourth quarter was 28% compared to 20.8% in the prior year period. On a reported segment basis, Human Health segment sales were $64.5 million, an increase of 35% from the fourth quarter of fiscal 2014. Rising Pharmaceuticals sales increased by just under 64%, mainly due to the acquisition of PACK Pharmaceutical Ingredients which occurred on April 30, 2014. Strong unit sales of two products which we had recent price increases and the true up in our estimate of product returns based on our recent trends and experience, we review our accruals quarterly and to ensure they reflect the most recent trends we are experiencing. The change resulted in a favorable sales adjustment of $9.5 million and increased gross profit of $3.5 million recorded in the quarter. On the nutritional side, the sluggish pace of reorders we've experienced in our first three fiscal quarters this year extended into the fourth fiscal quarter. The absence of royalty income from our proprietary product realized in the prior year's quarter also continued to negatively impact the year-over-year comparison. On the nutritional side, the sluggish pace of reorders we’ve experienced in our first three fiscal quarters this year extended into the fourth fiscal quarter. The ability -- pardon me, the absence of royalty income from a proprietary product realized in the prior year’s quarter also continued to negatively impact…

Operator

Operator

Thank you, everyone. I will begin the questions-and-answer session. [Operator Instructions] And our first question is from Matt Hewitt from Craig-Hallum Capital. Please go ahead.

Matt Hewitt

Analyst

Good morning, gentlemen and congratulations on a record quarter and year.

Sal Guccione

Management

Thank you, Matt. Good morning.

Matt Hewitt

Analyst

I’ve got a handful of questions. First off, do you have a breakdown for Q4 for the Human Health segment? How much of that was price versus the two new products that launched in the quarter?

Sal Guccione

Management

I don’t have that. And I don’t know we’d actually disclose that kind of information in the past to be honest, Matt. But I don’t have it with me.

Matt Hewitt

Analyst

Okay. Without getting into specifics, I guess, would you say it was primarily the new products that were launched or just given that you’d already had a quarter and a half of benefit from the price?

Sal Guccione

Management

No, I would say it was more due to the pricing, we took them earlier in the year and then it started to build -- the impact sort of built up over the course of quarters three and four. So off the top of my head, I’d say it was probably more the pricing than the new products.

Matt Hewitt

Analyst

Okay. And then, I guess, kind of sticking with that segment a little bit, gross margin obviously a phenomenal quarter across the board, but in the Human Health in particular, is that type of gross margin in the Human Health segment, is that sustainable or will that have some fluctuation as we look at ‘16 and beyond?

Sal Guccione

Management

I think there is always fluctuation. That margin, I think is maybe a little bit higher than we would get on a go forward basis. New products will probably increase that margin over time; there is always constant erosion due to competition on older products that brings it down. I’d say though for this quarter, it’s probably a little bit higher than sustainable. Doug?

Doug Roth

Management

Yeah. Matt, if you remember, we took a price increase and a charge if you will in our second fiscal quarter, and the benefit of the price increase we said would roll out in the third quarter, and then the full effect would be in the fourth quarter. So, I think we saw that, but don’t forget in the fourth quarter, as I mentioned earlier, we had a -- we always review our accruals and we took a favorable adjustment that affected our gross profit by about $3.5 million in the fourth quarter, so that’s in there too.

Matt Hewitt

Analyst

Okay, alright.

Sal Guccione

Management

If you strip that out, I think that would be a sustainable margin.

Matt Hewitt

Analyst

Okay. That’s helpful. Thank you. Kind of moving down the income statement a little bit, SG&A, are there some additional leverage opportunities from the PACK acquisition or are we kind of seeing that integration at this point?

Sal Guccione

Management

The fourth quarter really represents the full integration of PACK, and so I would not expect to see further consolidation savings there.

Matt Hewitt

Analyst

Okay.

Sal Guccione

Management

Matt, just I want to clarify one point. We just talked about when we said we actually strip out the $3.5 million that would be kind of a more of a normal [indiscernible], however, that $3.5 million did impact our P&L earlier in the year. Doug?

Doug Roth

Management

Well, I mean on its own, if you were to look at the fourth quarter, if you would have made this adjustment earlier in the year, then you would strip out the $3.5 million, but it would have been favorably adjusted by like $700,000.

Sal Guccione

Management

So my point being, it is kind of an ongoing -- when you look at it on an annual basis, they should be stripped out so to speak.

Doug Roth

Management

Correct. But I’m just speaking to the fourth quarter run rate.

Sal Guccione

Management

Just wanted to clarify that.

Matt Hewitt

Analyst

Okay. Thank you. Quick clarification on the ANDAs, I think in your prepared remarks, you said 57, but the press release said 60, just want to clarify what is the right number and when you look at this year, the 6 to 10 launches that you’re anticipating, are those products that have already been approved or how many of those have been approved or are those all new?

Sal Guccione

Management

Yeah. So the 57 are products that are currently on file with the FDA. We do have three that have received already approval, have gone through the system and are waiting launch and there are different things around those, whether it’d be supply chain or just timing of things like that. So the 60 is the accurate number, but 57 are on file with the FDA.

Matt Hewitt

Analyst

Perfect. Thank you. And then as you look at this upcoming year, so you’ve got three of the 6 to 10 you said you anticipated launching this year, the other three to seven are those than ones that you’re anticipating just based up on the ripeness of that portfolio?

Sal Guccione

Management

That’s correct. Yeah.

Matt Hewitt

Analyst

Okay. And then sticking on that theme, how many of your ANDAs were have been submitted in [indiscernible], so they would fall into that expedited timeframe?

Sal Guccione

Management

So let me see if I’ve got this, I think that’s on our roadshow. Let me just put out what we have here. It’s seven, I believe seven have been in the [indiscernible].

Matt Hewitt

Analyst

Seven, okay. So just based upon -- assuming the FDA is going to hit their targets just based upon those seven, you’d anticipate something like three of those approved within the first or within 15 months, so that’s additional great news. As far as looking at the R&D, obviously a big step up in FY ‘16, its sounds like a lot of that is going to be anticipated milestone and new projects, but are any of those ACETO driven or are these still through partnerships?

Sal Guccione

Management

Well our model is, when you say ACETO driven, they are driven by us in terms of product selection, but they are, our model is still partnership so they are in conjunction with development partners.

Matt Hewitt

Analyst

Okay, okay. Maybe a couple more and then I’ll hop back in the queue. First, from an M&A perspective, obviously the market remains pretty high particularly on that, especially generics side of the business, but what are you seeing, are you still actively looking for more targets whether they’d be products, portfolios of products, or entire companies?

Sal Guccione

Management

Absolutely, we are looking at both products as well as entire companies. We’re seeing not that this is you know means that we’re going to end up closing anything, but we are seeing more, slightly more properties becoming available. So, that’s somewhat encouraging, because for a while there is actually just kind of very limited opportunities, we’re seeing more opportunities both in terms of products as well as companies, now we’ll just have to see where it takes us forward, definitely looking.

Matt Hewitt

Analyst

Okay. And then, one last one on me, and I guess this is more on especially chemical side of the business, but the Chinese manufacturing market has been weak it’s been all over the news recently, what type of impact could that have on your business, I know you’re not selling into that market but obviously you’re sourcing from that market, how can that -- how does that impact your business?

Sal Guccione

Management

We look at it as a neutral to slightly positive. As that market weakens that increases how our supply partners desire to do business and hence potentially puts us in a better position from a cost point of view. Obviously our customers are smart also and so they will look to push back on us but we see there is neutral to slightly positive.

Matt Hewitt

Analyst

Okay, great. Thank you very much for taking the questions and congratulations again.

Sal Guccione

Management

Thank you, our pleasure thank you.

Operator

Operator

Our next question is from Steve Howard from Morgan Stanley.

Steve Howard

Analyst

Hi Sal, good morning thanks for taking the call.

Sal Guccione

Management

Good morning Steve, how are you?

Steve Howard

Analyst

Good, in terms of the full-year guidance, what’s doing the bulk of the heavy lifting, is it the maturation of the fiscal ’15 later launches in the pricing or is it the six out of ten new product launches?

Sal Guccione

Management

I would say, it’s right down in the middle, it’s both those. But launches will occur as the year goes on, so they’ll have greater impact in the second half of the year -- they’ll have a greater impact in the first half of the year.

Steve Howard

Analyst

Okay. And then, in terms of the broad portfolio of guidance and acknowledging the quarterly lumpiness, would you feel comfortable with that low double-digit bottom line number with six new launches instead of ten, or is that kind of the midpoint needed to achieve that double digit number?

Sal Guccione

Management

It’s an interesting question. It’s one thing that kind of depends, it depends on which products get approved because some are large and some are lower, so I hate to hedge it but I then would feel, I then would feel comfortable with the six, assuming it’s the right six, let’s put it that way.

Steve Howard

Analyst

Okay, thank you very much, good luck.

Sal Guccione

Management

Thank you.

Operator

Operator

Our next question is from Jeremy Hellman from Singular Research.

Jeremy Hellman

Analyst

Hi guys I apologize I was going to ask you about the M&A landscape as well which the first questioner asked about. Sorry about that.

Sal Guccione

Management

No problem.

Operator

Operator

And we have a question from Ben Natter from Emrose Capital.

Ben Natter

Analyst

Hi, just wondering on the accrual, what was the revenue impact of that, I’m sorry if I heard that it might be different from the gross profit impact.

Doug Roth

Management

What we said was the revenue impact in the fourth quarter was $9.5 million.

Ben Natter

Analyst

Okay, great. And as you guys look at working capital, I think you said it would be stable, did you mean in terms like in relationship to sales, like on a DSO basis or did you mean in terms of dollars as you move throughout the rest of the year?

Doug Roth

Management

On your former, in another words on a DSO basis.

Ben Natter

Analyst

Okay, okay, great thanks for the strong quarter and good luck for the rest of the year.

Doug Roth

Management

Thank you.

Sal Guccione

Management

Thank you.

Operator

Operator

[Operator Instructions] And I have no further questions at this time.

Sal Guccione

Management

Okay, well in that case then, again thank you all for joining us here today. As you could see from our results and today’s discussion we’re very pleased with 2015 and we’re looking forward to ’16. We’ll see you or talk to you in November for our first quarter results. Thanks again and enjoy the last few days of summer here, we’ll see you.

Operator

Operator

Thank you ladies and gentlemen that concludes today’s conference. Thank you for participating, you may now disconnect.