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Lannett (NYSE:LCI)

2014 Earnings Call

August 27, 2014 4:30 pm ET

Executives

Robert Jaffe - Principal and Senior Vice President

Arthur P. Bedrosian - Chief Executive Officer, President, Director and Chairman of Strategic Planning Committee

Martin P. Galvan - Chief Financial Officer, Vice President of Finance and Treasurer

Analysts

Matthew G. Hewitt - Craig-Hallum Capital Group LLC, Research Division

John L. Newman - Canaccord Genuity, Research Division

Rohit Vanjani - Oppenheimer & Co. Inc., Research Division

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Serge Belanger - Needham & Company, LLC, Research Division

Jay Richard Harris - Axiom Capital Management Inc., Research Division

Tom Bishop - BI Research

Jacob Hagop Yahiayan - Continental Advisory Services LLC

Todd Ammons - Grandmaster Capital Management

Blake Goodner - Bridger Management, LLC

Operator

Hello and welcome to the Lannett Company Fiscal 2014 Fourth Quarter and Full Year Financial Results Conference Call. My name is Erick. I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the call over to Robert Jaffe, Investor Relations for Lannett Company. Mr. Jaffe, you may begin.

Robert Jaffe

Thanks, Erick. Good afternoon everyone and thank you for joining us today to discuss Lannett Company's fiscal 2014 fourth quarter financial results. On the call today are Arthur Bedrosian, President and CEO, and Marty Galvan, our Chief Financial Officer.

This call is being broadcast live at www.lannett.com. A playback will be available for 3 months on Lannett's website. I'd like to make the cautionary statement and remind everyone that all of the information discussed on today's call is covered under the Safe Harbor provisions of the Litigation Reform Act. The company's discussion will include forward-looking information reflecting management's current forecast of certain aspects of the company's future and actual results could differ materially from those stated or implied.

This afternoon, Arthur will provide a brief overview, and Marty will discuss the financial results for the quarter in more detail. Followed by Arthur's concluding remarks. We will then open the call for questions. With that said, I'll turn now the call over to Arthur Bedrosian. Arthur?

Arthur P. Bedrosian

Thanks, Robert, and good afternoon everyone. I hope you enjoyed our latest theme song, Don't Stop Believing by Journey, and I hope that you can keep on believing in our ability to deliver excellent results.

I'm happy to report that we had an outstanding year. For the fiscal 2014 fourth quarter, we recorded the highest net sales, gross margin and net income in our company's 72-year history.

Compared with last year's fourth quarter, net sales doubled to $81 million, gross margin more than tripled, and net income grew 6-fold to $24 million, equal to $0.64 per diluted share.

We have reported 7 consecutive quarters of record net sales, as well as the 10th consecutive quarter in which net sales and adjusted earnings per share exceeded the comparable prior year period.

Throughout fiscal 2014, we generated strong momentum. This gives us confidence in our outlook for fiscal 2015, which Marty will discuss in more detail shortly. With that brief overview, I'd like to turn the call over to Marty to review the financials, then I'll provide an operational update and we'll open the call to questions. Marty?

Martin P. Galvan

Thank you, Arthur, and good afternoon everyone. As Arthur mentioned, we reported a tremendous fiscal 2014 fourth quarter and full year. For our fourth quarter, net sales, which included upfront credits related to price increases, doubled to $80.6 million from $40.2 million in last year's fourth quarter.

Net sales for our largest product category, thyroid deficiency, grew to $27.7 million or 34% of our total net sales. Our 2 other largest categories, cardiovascular and pain management, had net sales of $19.3 million and $6.8 million, respectively, representing 24% and 8% of our total net sales respectively. As to net sales of our remaining categories: migraine was $4.7 million; glaucoma was $4.5 million; gout was $3.4 million; gallstone was $3.1 million; antibiotic was $2.5 million; obesity was $1.1 million; and other represented $7.5 million. Gross profit more than tripled to $55.9 million or 69% of net sales, from $15.2 million or 38% of net sales.

Research and development expenses increased to $6.6 million compared with $3.7 million in the same quarter of the prior year. Selling, general and administrative expenses increased to $12 million compared with $5.8 million. Operating income reflected exceptional growth, increasing to $37.4 million from $5.7 million in the fourth quarter of fiscal 2013. Net income attributable to Lannett Company grew sixfold to $23.5 million or $0.64 per diluted share from $3.6 million or $0.12 per diluted share.

Now comparing fiscal 2014 full year with the prior year. Net sales rose 81% to $273.8 million from $151.1 million. With respect to cost of sales and as previously announced, we issued 1.5 million shares of our common stock in connection with the signing of a contract extension with Jerome Stevens Pharmaceuticals. As a result, cost of sales for fiscal 2014 included a nonrecurring pretax charge of $20.1 million related to this contract extension.

Continuing with the remainder of the income statement and for completeness and comparative purposes, I will provide both GAAP and adjusted amounts for gross profit, operating income and net income. Gross profit on a GAAP basis was $154.4 million or 56% of net sales. Excluding the JSP contract renewal charge, gross profit was $174 million -- $174.5 million or 64% of net sales. This compares with gross profit of -- for last year of $57.4 million or 38% of net sales. R&D expenses increased to $27.7 million from $16.3 million. SG&A expenses increased to $38.6 million from $22.4 million. Operating income reported in accordance with GAAP was $88.1 million. Excluding the JSP contract renewal charge, operating income was $108.2 million compared with $18.8 million in fiscal 2013. GAAP to net income attributable to Lannett Company was $57.1 million or $1.62 per diluted share. Adjusted net income, which excludes the impact of the JSP contract renewal charge, equal to $12.6 million after tax, was $69.7 million or $1.98 per diluted share. This compares with net income attributable to Lannett for fiscal 2013 of $13.3 million or $0.46 per diluted share.

Fiscal 2013 included a favorable pretax litigation settlement of $1.3 million equal to $0.03 per diluted share.

Our balance sheet at June 30, 2014 remains strong with cash, cash equivalents and investment securities totaling $146.3 million.

Turning now to our guidance. We expect the following for the full year fiscal 2015: Net sales in the range of $350 million to $370 million; gross margin as a percentage of net sales of approximately 70% to 72%; R&D expense in the range of $36 million to $38 million; SG&A expense ranging from $47 million to $49 million; the full year effective tax rate to be in the range of 36% to 38%.

And regarding the phasing of the quarters in fiscal 2015, in Q1 compared to Q4 of fiscal 2014, we expect higher net sales with similar total operating expenses. In the second quarter, we anticipate a decrease in net sales, mainly due to competition in Digoxin and an increase in total operating expenses compared to Q1.

Lastly, we expect quarters 3 and 4 to be at a similar level to the second quarter in both net sales and operating expenses. Capital expenditures in fiscal 2015 in the range of $40 million to $50 million, which includes $7 million to continue the preparation and partial fit out of 2 buildings recently acquired by the company.

With that, I will now turn the call back over to Arthur.

Arthur P. Bedrosian

Thank you, Marty. I want to briefly address 2 items related to the Digoxin. As we previously announced, the Attorney General's Office of the State of Connecticut has initiated an investigation into pricing of Digoxin. We firmly believe we have acted in full compliance with all applicable laws and regulations. We are cooperating with the Attorney General's Office. I can assure you that our product pricing decisions are made independently by the company. Period. The other item involving Digoxin relates to a recently published abstract in a medical journal of a limited study conducted in the veterans administration health care complex. In response to this study, Canaccord recently issued an analyst note on August 20 with the headline Digoxin Mortality Data Unlikely to Affect Clinical Practice. In the note, the analyst reported that physicians will not change practice due to a lack of options and continue to use Digoxin since these patients are much sicker than the average AFib population.

We had already anticipated lower sales of Digoxin for the coming year due to expected competition. However, while we agree with the conclusions reached in the Canaccord note, our guidance for fiscal 2015 reflects a further reduction to expected sales of Digoxin as a result of the abstract. For fiscal 2015, we now estimate sales of this product to be approximately $35 million, which is less than 10% of our anticipated full year net revenues.

Looking ahead, we believe the company is positioned for continued success. We recently formed 2 strategic alliances, purchased 2 ANDAs and entered into an agreement with Symplmed. Pursuant to our strategic plan, over the last couple of months, we received approvals for 3 scheduled drugs. Diazepam Oral Solution concentrate, 5 milligram per ml; Codeine Sulfate Tablets USP, 15, 30 and 60 milligrams; and Oxycodone Hydrochloride Capsules, 5 milligram. We expect all 3 of these products to contribute to our fiscal 2015 performance. We continue to build out our pipeline. We currently have 23 ANDAs including 4 with Paragraph IV certifications pending at the FDA. Of our additional 45 products in various stages of development, we expect to submit several additional product applications in the near future, and our plans call for the continued and significant investment in R&D. We believe it is important to increase our product development activities to drive future growth.

Regarding our Oxycodone Oral Solution, I continue to press the FDA for that approval. With our specialty pharma business, we currently have 11 sales representatives detailing our C-Topical solution product. We commenced our Phase III clinical trial and although we have faced delays in recruiting the physicians and patients, we are still targeting December of this year to submit our NDA. We continue to wait for an FDA response to our suitability petition for companion drug product for our sales force.

On the M&A front, we have had discussions with a number of parties, and while we have not been able to complete a deal, I remain optimistic. Our team continues to look at products, as well as companies that are a strategic fit and accretive to our business. We are particularly interested in opportunities to globalize and further vertically integrate our operations. In addition, we are focused on searching for a potential acquisition in a tax-favorable jurisdiction to enhance shareholder value.

To sum up, we continue to be very positive about Lannett's future. I'd like to take this opportunity to thank my colleagues for their dedication and hard work and our customers and shareholders for their continued support and confidence.

Marty and I would now like to address any questions you may have. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from Matt Hewitt with Craig-Hallum.

Matthew G. Hewitt - Craig-Hallum Capital Group LLC, Research Division

First question, and it's more to get this out of the way. Digoxin. In your press release, and I think that you were -- you worded it very carefully regarding how that drug was going to taper off in 2015. Do you have any way to know whether or not much of that decline is related to the new competition versus price or this new JACC study? Is there any way to delineate between those 2?

Arthur P. Bedrosian

Well, we anticipated the competition. As I had said previously, I expected West-Ward to relaunch around June, July. So far, I've been wrong. They haven't really launched the product yet. I did anticipate Caraco to come back in the market of December of this year. And then they announced the closure of their Detroit plant wherein they make the Digoxin product. So it's possible that, that entry is going to be delayed. Nevertheless, we always use a very conservative point of view. And bear in mind, we're always presuming that when these enters -- these entries, I should say, come into the market, they're going to take market share away from Lannett, but it's very possible they'll take market share away from Par or from Impax. But nevertheless, when we're giving our guidance, we try to be conservative. So we took it into consideration that the 2 new competitors could come into the market and we could lose market share to them, and that's why we made the projections more conservative going forward. I personally don't see any loss because of that study. I have not projected that. I believe Marty, in his conservative point of view, brought it down a little bit just to be conservative like we are. But I personally don't think there's going to be any changes because of that study.

Matthew G. Hewitt - Craig-Hallum Capital Group LLC, Research Division

Okay. And fair enough. How about from a pricing standpoint? I mean, some of the cardiologists that I was speaking with were saying that they were getting pushback from their patients who -- elderly, fixed income, whatever their reasoning, they no longer could afford that on a monthly basis. Have you seen anything from that side of it?

Arthur P. Bedrosian

No, we haven't. But we're not -- I'm sympathetic to this problem. The problem always that we face in the business is if we're not in business, then the harm is greater to those same patients. The product remains high priced because only the brand remains. We're facing additional costs in our business because of the new changes to the stability work that we have to do in filing ANDAs. We're going to be filing less ANDAs as a result of the change from 3 months accelerated, 1 commercial lot to 3 commercial lots, 6 month-accelerated. Those cost increases, plus the GDUFA fees, plus the PDUFA fees that are now at $3 million an application when they were only $1.5 million 2 years ago. If we don't have the money to pay for these things, how do we survive as a business? So while it hurts the people who are on fixed incomes, we don't really have a choice as a business to operate and not raise prices when we have opportunities. Generally, as we all know in our business, we have to decline our prices because of competition, keeping in tune with the competition. Occasionally, when you have opportunities to raise the price, if you don't take advantage of that, then all you have is low-priced goods and eventually you won't be in business. The cost of operating a drug company today is enormously high and we need to be profitable to pay for those expenses.

Matthew G. Hewitt - Craig-Hallum Capital Group LLC, Research Division

I understand completely and -- yes, I agree. All right. Shifting to, I guess, some more pertinent topics. The 2 products that you recently acquired, I think in the press release, you stated that it'd be a couple of months to get the one launched. I'm assuming that's just getting a site transfer completed and then the second, a couple of months after that. I mean, are those like -- is that a Q2 launch and then a Q3 launch? Is that how should we be thinking about that in our models?

Arthur P. Bedrosian

I mean, well, first of all, the only one we're giving an estimate to is the Estradiol tablets, and that one we said probably will be a Q2 launch. We haven't given a date for the other product, the Selegiline.

Matthew G. Hewitt - Craig-Hallum Capital Group LLC, Research Division

Okay. All right. Fair enough. And the Estradiol was -- that was the larger of the 2 markets though, correct?

Arthur P. Bedrosian

Correct. And that will be a Q2 launch.

Matthew G. Hewitt - Craig-Hallum Capital Group LLC, Research Division

Okay. Fair enough. And then maybe one more for me and then I'll hop back in the queue. You were able to get 4 applications -- or 4 ANDAs applications. I'm assuming those got in under the gun for the GDUFA changes last quarter. As you look out towards this October deadline when -- the FDA has basically stated that if you wait until after October 1, then we promise that 70% of applications will be approved within 18 months. Are you looking at that as maybe the next window when you would see an uptick in your filings? Or are you just getting them out as soon as you can?

Arthur P. Bedrosian

No, we've had discussions about that issue internally. We're getting them out as soon as we can. The FDA's guidance is like giving you dates when they're going to approve things and it's been our experience, usually, don't come to pass. So we're not going to wait around for October. If everybody does that, they may not be prepared to handle that onslaught. And a lot of people suggested that you're better off submitting your applications when they're ready and not try to play that game. So we're going to be pessimists on this one and presume the FDA will not be able to meet their projected deliveries on approvals. So we're going to have things at the agency. And my attitude is whatever's at the agency eventually gets approved and we eventually launch those products. So while I'm unable to ever say with any certainty, "we're not going to have a product approved," at least I know I'm always going to have products coming in to the company being approved and being launched, so the revenue stream will continue to grow.

Operator

And the next question comes from John Newman with Canaccord.

John L. Newman - Canaccord Genuity, Research Division

I have a couple of questions actually. The first one is a question for Marty. Marty, what does the guidance for 2015 assume in terms of new ANDA approvals?

Martin P. Galvan

As far as -- John, as far as new ANDA approvals or any product approval, we've assumed -- we have taken a conservative position, basically, nothing much in there at all. The only thing that might be of significance is the oxycodone, the solution we have in there for the second half of the year and that's under $5 million.

John L. Newman - Canaccord Genuity, Research Division

Okay. The second question is for Arthur. Arthur, in terms of some of the noise regarding the investigation by the Connecticut AG, will that have any effect whatsoever on your attitude and stance on continuing to raise price when possible, going forward, on your products?

Arthur P. Bedrosian

None whatsoever. Matter of fact, I think price increases are opportunistic things. You don't know when you're going to have the opportunity and when you do, you take advantage of it. We know we've done nothing wrong, so we're going to continue to operate our business regardless of any investigation. And we certainly welcome it, so that it could be closed and everybody could be assured that nothing untoward occurred here. But it's not going to drive our business decisions at all.

John L. Newman - Canaccord Genuity, Research Division

Okay, great. And the final question is just an additional question on Digoxin. Given that there have been questions surrounding Digoxin for many years, there have been many studies that have been done, some of which have shown a risk in AFib and/or heart failure and others which have not, I'm just wondering, it definitely sounds like you are being conservative in terms of assuming that there is some effect from the recently published study. But I'm just wondering if we do see an effect, if you were to -- if you would expect it to be sustained or if you would expect it to be transient? I just ask because we were able to speak with several cardiologists, none of whom have said the study would have any effect whatsoever on their practice and these were all cardiologists in very large New York and Chicago hospitals.

Arthur P. Bedrosian

That's the consensus we have here as well. When the drug is working in a patient, the doctor doesn't switch it around just because the cost went up because he's more interested in protecting his patient, not his patient's wallet. Because you want to treat people with the disease and protect them. So if a drug is working for you, they're going to tell the patient, "Listen, this drug is protecting you. You're not dying, leave it alone." Experimenting with other drugs brings additional side effects to that patient. So any doctor is most likely going to think twice before he switches a patient away just because of a study. And let's understand the focus of where that study was conducted, at the VA.

John L. Newman - Canaccord Genuity, Research Division

Right. Exactly. And one quick final question. Can you give us any additional color or update on the status of your ANDA for THALOMID?

Arthur P. Bedrosian

No, we're awaiting the acceptance letter and then we'll send the notification to Celgene. We expect that shortly.

Operator

And our next question comes from Rohit Vanjani with Oppenheimer.

Rohit Vanjani - Oppenheimer & Co. Inc., Research Division

So just to be clear on the Digoxin, when you said that West-Ward was -- maybe last quarter, when you said it's going to come in midyear and then Sun Caraco by the end of the year, are you still anticipating that West-Ward is going to come in anytime and Sun Caraco by the end of the year, or does your new Digoxin reflect delays in those entrants?

Arthur P. Bedrosian

Well, in the Caraco case, I'm really thinking maybe I'm going to be wrong about December because they announced the closure of the plant. And at the same time, they made the acquisition of Ranbaxy. So there's an awful lot on some pharmaceuticals' plate, least of which is Digoxin to be concerned with. So I'm less concerned about Caraco this time. West-Ward has not launched, but I do expect it any day now.

Rohit Vanjani - Oppenheimer & Co. Inc., Research Division

Okay. And then I think last time, on the last quarter, you may have said or maybe when we talked afterwards, you were saying that Digoxin was annualizing at $80 million. And then when you gave the guidance last quarter of $330 million to $350 million, you were expecting Digoxin to go to $40 million for next year. So the new guidance of $35 million, is that fair to say that you're expecting a $5 million impact from the JACC study?

Martin P. Galvan

Yes. Well, Rohit, I guess -- this is Marty. That's the -- as Arthur mentioned earlier, from a numbers perspective, we were being conservative with our outlook for the product and that's correct. So that additional reduction is to take into account any impact that we might see from the abstract.

Rohit Vanjani - Oppenheimer & Co. Inc., Research Division

Okay. And then for the guidance, for the new guidance, Ursodiol. What was that product annualizing at? And what does that assume for fiscal 2015 for Ursodiol?

Martin P. Galvan

Well, we spoke the last earnings call about an increase, a significant increase on the product. It was annualizing at about $50 million. We -- in our guidance though, we had -- we don't -- we haven't picked up all $50 million. We picked it up for about 3 quarters of the $50 million, so something in the $30 million to $35 million range. Just anticipating that market conditions would go the other way again within, say, 9 months or so.

Rohit Vanjani - Oppenheimer & Co. Inc., Research Division

Okay. And then are you valuing anything from the Sunshine Lake agreement in your guidance?

Martin P. Galvan

No. Nothing in there for that yet as far as this date.

Rohit Vanjani - Oppenheimer & Co. Inc., Research Division

And then the last one for me is, I think the Connecticut AG, the interrogatories asked you to submit answers to their questions by 8/15. Is that correct? And if that's the case, have you submitted everything to them, to the Connecticut AG?

Arthur P. Bedrosian

I don't have it in front of me, but I believe that was correct. But if you recall, the AG was on vacation. So at this point, I don't believe anything's been delivered to them. But I'd have to check with my outside counsel. But I believe nothing's been delivered yet. Because I know there was some issue with them being on vacation, but they were discussing that and I'm not up-to-date on that.

Operator

The next question comes from Scott Henry with Roth Capital.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

A couple of questions. For starters, so the guidance basically went from $330 million to $350 million, to $350 million to $370 million. Factor in $5 million pullback for Digoxin. Is the upside driver, is that mostly Ursodiol? Or I'm just curious of any clarity on what drove that uptick.

Martin P. Galvan

That's not the one product, Scott. It's the basket of products. When we gave those, the initial thinking back on May 7, it was early stage. We had not yet completed our own internal budgeting process and the process we do go through here. So right now, it's a refinement essentially of the numbers we had back then. And then we had a strong fourth quarter as we just reported. And obviously that factors into our thinking for fiscal 2015.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Okay. Great. And then on Digoxin, you gave that guidance of $35 million for 2015, perhaps conservative. How should I think of Digoxin relative to the cardiovascular category? I mean, about what percent of that category is Digoxin?

Martin P. Galvan

It's certainly the bulk of that, Scott. The other product in that category is the generic Dyazide that we launched about 3 years ago or so now, 2.5 years ago. And it's Digoxin numbers. Digoxin is essentially most -- almost -- essentially all of that category right now.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Okay. All right. And I guess just the only other thing to talk about, I guess, would be Levo and I don't know if you could give any kind of clarity on what you're thinking for 2015? I guess, we should still see an uptick in Q1 from Q4, I imagine. And it looks like when you run the numbers, that could be $30 million to $35 million or so a quarter. I'm just wondering if I'm thinking about that correctly.

Martin P. Galvan

You're in the right ballpark. I mean, yes, you're in the right ballpark.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Okay. And Arthur, are there any thoughts on future competition to Levo? Just anything you may be hearing in the trade, or even Marty, when you make your forecast, do you expect any new competition for Levo in the next fiscal year?

Arthur P. Bedrosian

No. We've heard nothing in the trade and we've made no arrangements to anticipate anything for this fiscal year.

Operator

The next question comes from Serge Belanger with Needham.

Serge Belanger - Needham & Company, LLC, Research Division

Just one more and Digoxin seems to be the topic du jour. Seen prescription volumes -- the recent prescription volumes have been down about 30% since February. So does this $35 million that Marty mentioned assume further declines or some near-term stability?

Martin P. Galvan

It assumes that the -- and depending on the source that you're using for the market share, our share back in the wintertime and January time, let's say, February, even, I thought it was much higher. It was up in the 50% and 60% range. And while we assumed to get to our 2015 numbers, we assumed that, that market share would be dropped by 1/2. So let's just say whatever number you believe in terms of market share, we saw the x factory shipments on our side, we just assume there are x factories would be cut by about half reflecting, again, a loss of 1/2 of the market share. And then we took an additional reduction for the abstract as we just mentioned.

Serge Belanger - Needham & Company, LLC, Research Division

Okay. And then on Levo, we've seen your 2 main large competitors, more or less exchange market share between them. Do you know if they've lost any key customers and does that present any opportunities for Lannett?

Arthur P. Bedrosian

No, but we're always looking for opportunities. But that happens though. We do lose customers, we gain customers, sometimes is just evens out at the end. We do know that 2 of our competitors did exchange a customer between them. But that is somewhat routine in our business. It happens to all of us. We hopefully have less of it than our competitors because we give better service. And if we don't, we'll struggle that way as well.

Operator

The next question comes from Jay Harris with Axiom Capital.

Jay Richard Harris - Axiom Capital Management Inc., Research Division

I presume that the relatively flat revenues going from the third to the fourth quarter was due to volume declines. Can I get an estimate of the order of magnitude?

Martin P. Galvan

The -- we're not getting that specific. But you're right. I mean, it is essentially the volume declines. With the mix of over 30 products we have, there's just offsets up and down the line. But essentially what you're seeing, as I mentioned on the -- in the prepared remarks, when we talked about the guidance for fiscal 2015, the driver that's dropping sales from the first quarter or what we expect to be a drop from a high first quarter going down into our second quarter, that decrease was -- the predominant piece is Digoxin coming down. And then we expect that our sales for various reasons will essentially be flat for the remaining quarters of the year, but it's the volume on Digoxin.

Jay Richard Harris - Axiom Capital Management Inc., Research Division

Is there any way you could say, "Our volume was off $1 million, $2 million, $3 million, third to the fourth quarter" without referring to any products?

Martin P. Galvan

Well, I could but here's where we're not going to get that specific with the guidance at this stage. It's, as I said, it's relatively --

Jay Richard Harris - Axiom Capital Management Inc., Research Division

I'm talking about this year that you just reported.

Martin P. Galvan

Oh, I'm sorry. This past year, this past year.

Jay Richard Harris - Axiom Capital Management Inc., Research Division

Yes, the past year.

Martin P. Galvan

Okay. So I'm sorry. The -- well, the third and fourth quarters, they are flat, right?

Jay Richard Harris - Axiom Capital Management Inc., Research Division

Yes, but when you did your conference call in May, you indicated that you were increasing prices and you were worried about volume decline.

Martin P. Galvan

Okay, I'm sorry. I see what you're saying, yes. So what we saw -- what drove the fourth quarter to be stronger than we anticipated, let me try it this way, was volume basically.

Jay Richard Harris - Axiom Capital Management Inc., Research Division

I understood that. But if you've raised the -- I am assuming you've raised prices more than the $600,000 increase in revenues. And that's...

Arthur P. Bedrosian

Well, what happened is while we raised prices, we expected some of the buy ends to hurt the revenues for that quarter. So -- you could say we were a little bit too conservative in our projected loss for that fourth quarter over the third quarter, so that there wasn't -- the drop wasn't as severe as we thought. We also gained market share on some products that we didn't expect to get. So some...

Jay Richard Harris - Axiom Capital Management Inc., Research Division

So you had offset -- you had a positive offset in volume?

Arthur P. Bedrosian

Yes.

Martin P. Galvan

Yes.

Operator

Next question comes from Tom Bishop with BI Research.

Tom Bishop - BI Research

When I added up the pieces of the revenue, I came up a little short. I got only $54 million. I'm guessing I missed the thyroid number. Could you give us that again?

Martin P. Galvan

Sure. The -- just hold on one second. The thyroid number for the fourth quarter, it's 27 -- $27.7 million.

Tom Bishop - BI Research

Okay. Just a comment on Digoxin -- well, and a question. It seems to me when generic companies follow each other with lower prices until profit margins are kind of low, that's free market competition. But when they follow each other up in price, then it's considered price fixing. To me, it makes sense that generic companies would follow each other up in price just like they do on the way down. My question is: I understand an authorized generic came out around the time of the price increase in Digoxin. And how does your generic price relate to the authorized generics price?

Arthur P. Bedrosian

Well, we were lucky that the authorized generics supplier was a rational competitor. And when they introduced their product, they introduced theirs at a higher profit -- I mean, a higher margin, excuse me. A higher WAC price, wholesale acquisition cost, is the number that I'm going to reflect here. Theirs is a little higher than ours, ours was a little higher than Impax's. So in that sense, we didn't get hurt by the price so there's no price erosion. However, as we all have favorite customers, they have some accounts that were closer to them than to us and we lost some units as we had predicted we would once we knew who the other competitor was. We also didn't think that they would launch the authorized generic as quickly as they did. So we were a little surprised at how quickly they launched, but we did anticipate the unit loss and it turned out to be just about what we said it would be. Roughly in units, but dollars, we're not losing anything. The competition -- the prices, of course, have come down a little bit from the WAC prices I just described, but that's typical of what goes on because everybody has prices that they give different customers. And when you average them together, that's -- what you're getting is the real price, let's say, versus the wholesale acquisition price. Think of it like a list price on a car. Every dealer negotiates a different price when they sell it, but the list price is the same. In our case, those prices were just what I described. The authorized generic was higher than we were. We were higher than Impax.

Tom Bishop - BI Research

Okay. So he's complain -- the Attorney General's complaining about the prices of the nonauthorized generics even though the authorized generics is the same price, right?

Arthur P. Bedrosian

Well, no, we presume he's looking at those companies too. We -- they're not a public company. They're owned by private equity. So we may not be aware that Par got a subpoena, but I would be surprised if they didn't receive one or Caraco and West-Ward. If you looked at subpoena, they listed over 39 different names for Digoxin, both chemical and brand names. I got to tell you, I didn't even recognize those 39 names and I've been in the business 46 years. And I've seen a lot of people sell Digoxin. So they look like they went to the -- to some database to see how many products are on the market and then took that approach. So that's my guess at this point. So I'm presuming everybody received that subpoena, but we really don't know that.

Tom Bishop - BI Research

Okay. Can you say what the branded sales of the 23 ANDAs is or...

Arthur P. Bedrosian

I don't -- I mean, we -- I don't have the total, actually. I was thinking about the 5 at the agency that's only a billion. Now I don't, but if you want to contact us at a later date, I could certainly get you that.

Tom Bishop - BI Research

Okay. When I first got involved with Lannett, I don't know, around the start of the year, the company was looking, I thought, and maybe I heard it wrong, but for 4 or 5 approvals by midyear, June 30, say, with 1 or 2 of them being really big. And I can't find it now, but I thought that the total of those 4 or 5 you were hoping to get by year end had a $1 billion in branded sales.

Arthur P. Bedrosian

That's correct. That was me saying that. You'll have to forgive me. When people ask me if the cup is half full or half empty, I'd tell you to pour it into a smaller cup. So I had expected with the best advice from our regulatory people here that we would get 5 approvals last fiscal year. Of the 5 I thought we would get, we didn't get one of them. And I did receive an approval on one of the Diazepams that I was not expecting. So predicting what the FDA is going to do is certainly not one of my strong suits but we still believe those are pending and we will get them approved.

Tom Bishop - BI Research

And so, there are some biggies in there? But...

Arthur P. Bedrosian

Yes, they're still down there. For example, one of them was an anorexia drug. I had anticipated to have by December. Now it looks like I'll be a year off. I'm still expecting it next month, but with my predictions, don't count on my estimates here, but we are expecting it. There's been a delay. We had an issue with the reviewer. We overcame it in a meeting with the FDA. We objected to their position on something and we prevailed, but I lost another 3 months during that process. These are some of the things that hurt us when we expect something to go through and all of a sudden, we run into a roadblock then by the time you could resolve it, 3 months go by. And that's doing our best, bringing in the ombudswoman to help us, my Washington counsel. It took us 3 months to have that hearing. And of course, we prevailed but the 3 months is gone. And now I'm still waiting for that product to be approved. That's another drug we thought we could do about $30 million annually with. It's not in our guidance but we are expecting it this fiscal year.

Tom Bishop - BI Research

Okay. Well, the longer it takes, the more likely, hopefully, they are to get approved soon. I hope.

Arthur P. Bedrosian

That's my attitude. They always get approved eventually. It's just I'm not getting any younger here waiting.

Operator

And our next question comes from Jacob Yahiayan with Continental Advisory.

Jacob Hagop Yahiayan - Continental Advisory Services LLC

This is more of a capacity question with regard to the property, plant and equipment. There is that $20 million pop-up year-over-year that was attributed to the 2 buildings and the $7 million that you're budgeting for the build out?

Arthur P. Bedrosian

That's correct. When we acquired those 2 buildings, 3 other companies came on the market with their facilities. Not going to mention all their names. I believe it is all public, but nevertheless, I don't want to be the one to reveal them. One very large brand company's facility in upstate New York, in Rockland County, there was 1 here in Pennsylvania, I'm not sure what county it is, but it's about 45 minutes from our facility. And another one, I would say, is in the Bergen County area or somewhere around Little Falls. So those particular facilities, 2 of them we've turned down. The third one, we're taking a serious look and we may decide to acquire that existing facility rather than fit out the ones, the IRS buildings that we bought here in town. We're not going to not fit out the buildings here. But I can spend less money and quickly have manufacturing capacity in the other brand company's facility as opposed to waiting 2 years to fit out mine. So we're always looking at these opportunities to save time and money and that just came up after we acquired them. Prior to our acquisition, those 2 buildings from the IRS, we looked for almost 3 years at a lot of companies that were closing down facilities and just didn't find anything suitable. But call it bad timing -- but we still got the IRS buildings so inexpensively that we will still plan to move into them. Just may get delayed a little.

Operator

And the next question comes from Todd Ammons with Grandmaster Capital.

Todd Ammons - Grandmaster Capital Management

Quickly on Levo itself. Do you guys disclose the gross margins?

Arthur P. Bedrosian

No, we don't.

Todd Ammons - Grandmaster Capital Management

Okay. And do you plan on taking any price on Levo at fiscal year 2015? Is that implied in your guidance or no?

Arthur P. Bedrosian

No, it's not implied in our guidance. And as we've told other people previously, we're restrained because we're at 75% of the innovator brand price. And generally in our world, you really can't sell the generic for more than the brand, and that usually is a fair discount for the brand. Usually, we're a lot lower than that as well. But unless AbbVie raises the price of the innovator product, that doesn't -- there won't be any price increases in our future on that product.

Todd Ammons - Grandmaster Capital Management

Okay. And then can you -- as you know it, what is the market share for Levo between yourselves, Mylan and Sandoz at this point?

Arthur P. Bedrosian

Well, the way I describe it, it's really between Mylan and Lannett, and I tend to give Mylan a little more market share than they currently have. I tend to tell people it's about a 70-30 split. If you factor in Sandoz and Sandoz picked up a customer away from Mylan I understand, Mylan might be at 68 and Sandoz might have picked up a couple of percentage points. But it really is, the bulk of the market is between Mylan and Lannett in terms of units that are sold.

Todd Ammons - Grandmaster Capital Management

Got it. And then previously, Sandoz had more market share, is that correct? And if so, what was it before they went off market?

Arthur P. Bedrosian

Well, I really don't know what their numbers were, but I know they went off market because of all the recalls they had and a lot of people got tired of these. This is a drug that's a narrow therapeutic index drug. You need to titrate the patients, so you don't want to have to keep switching patients because of recalls and lack of a product. So I believe that hurt their market and they lost some business because of that problem. That hasn't been resolved apparently because I understand recently they also had a recall. I'm not trying to disparage a competitor, don't misunderstand, but that was the reason for their market share loss.

Todd Ammons - Grandmaster Capital Management

Got it. So the 2% market share that they have now, you're expecting that to kind of hover around that level or do you expect them to claw back some of that market share this year?

Arthur P. Bedrosian

No, they don't -- most people who switched away from them don't really go back to them. That's really -- that's like the low-priced drug. So if someone's strictly buying on price, if you're a wholesaler, you would stock the product because those people that buy on price and price alone will buy the Sandoz product, let's say. It always was cheaper in the marketplace than Mylan and ours. And the reason for that is we won't match Sandoz's price. My product is a better quality product. I want to be paid for it. So that's one of the reasons why some people will buy the Sandoz product, because they're generally cheaper than my price and of course, cheaper than Mylan as well.

Operator

And our next question comes from Michael Shonack [ph] with Polar.

Unknown Analyst

Just on your CapEx guidance. I think you had said $7 million for 2 buildings you acquired fit out. What's the rest of the money being used for?

Martin P. Galvan

The rest of the money, we have some capital for fixed assets or building actually in our Cody, Wyoming API facility. And just throughout the rest of the company, we had spending in, basically, maintenance kind of CapEx.

Unknown Analyst

So is that a normal annual run rate of like $40 million or so, is a maintenance CapEx number? Or is that too high?

Martin P. Galvan

No, I would say the run rate, it is high, it's on the higher end this year primarily because of the building piece I mentioned in Cody, Wyoming. The -- generally speaking, we've been running more in that -- historically, in the high teens number, maybe $20 million annually. So this other $20 million this year that's of the more unusual nature with specific expansion plans in Cody, Wyoming. That's what gets you to the $40 million then.

Unknown Analyst

So after 2015, it might go back down to the $20 million range? Is that right?

Arthur P. Bedrosian

Well, I wouldn't say that. The FDA's requirements are getting tougher and tougher dealing with containment. And we don't expect prices to go down in terms of our CapEx expenditures. Just the opposite. We see them asking us to spend more and more money even on our older facilities to keep them current with current thinking, not necessarily GMP-compliant, with current thinking. So we expect to continue to see an increase in CapEx spending. We're also buying, always replacing equipment with more modern equipment. Equipment that's more readily automated. For example, have a lot of software and -- what's the word I'm looking for, software addition, so you could automate or control your processes better. So we're always trying to be a state-of-the-art manufacturer, not in the physical building alone but in equipment as well.

Unknown Analyst

Okay. Is there some metric in terms of percentage of sales of that you kind of target for CapEx or is it...

Arthur P. Bedrosian

Well, we've been very conservative in our expenditures. Generally, it's more upkeep, I would call what we spend money on. Unless we're fitting out a new facility, it's usually just upkeep, replacing things and providing more -- for example, the FDA's asked us to start to include more -- what would you call the door locks? Self-locking door locks? Airlocks. They want us to put in airlocks. They want us to put doors that lock automatically. There's this issue about cross-contamination sometimes. While we may not agree with it always because the way our business operates, we have this negative pressure in each one of the rooms. So if you open 2 doors into a hallway, there won't be any chance the product in each room will migrate to the other rooms because there are negative pressure. So the minute you open the door, the corridor air is brought into each room. Nevertheless, the FDA wants you to have better doors, better sealing on doors that close and self-lock. And these things cost money. But we agree with the FDA that these improvements aren't going to hurt us. Yes, they're costly, but anything that improves the cGMP environment is something we tend to embrace. But it's not cheap. That kind of equipment is very expensive. So we're always upgrading every one of our buildings. For example, in the labs, we're moving to more higher-speed HPLCs, what they now call UPLCs. So we're always replacing older equipment that is preferably well functioning, but it takes longer to do a test than the newer equipment does. Well, that also allows you not to have to expand the headcount as well.

Operator

The next question comes from Blake Goodner with Bridger.

Blake Goodner - Bridger Management, LLC

Yes. Just 3 quick questions. First one was on Levo, I just -- it's a little unclear to me. I know there have been 2 ANDAs from competitors sitting at FDA for a while. Are those assumed -- are you making any assumptions for those in the FY '15 outlook?

Arthur P. Bedrosian

No. Actually, we believe there are applications there and -- because we don't know first-hand. But we did know 1 case, a company in Europe that indicated they were going to get an approval and they reached out to a competitor to distribute it to them but we know that, that competitor turned them down. When we called them, they denied they even were working on a product. So we believe that there are people that have worked on it and probably have applications stranded at the agency. So some of those backlogs and delays are probably benefiting us as well.

Blake Goodner - Bridger Management, LLC

All right. But are you assuming any additional Levo competition?

Arthur P. Bedrosian

Not this year. Not this year.

Blake Goodner - Bridger Management, LLC

Got it. And then with Estradiol, the recent acquisition. I just missed that before. I know in the prior press release, you said it was like $32 million of branded sales, but what exactly are you assuming for Estradiol in the newly updated guidance because I don't think that was in the prior guidance. Just want to make sure I understand.

Arthur P. Bedrosian

It's not even in this guidance because unless we have the product on the shelf, we don't put it in the guidance. We're very conservative that way because the minute you run into delays or anything goes wrong, then everybody's been misled by us. So we try to be very careful. If we know we have the product, then it's in our guidance. If we don't, we wait until it comes in. But we do know we will have it in the next couple of months. We expect it in the second quarter. But what if it's at the end of second quarter? What if we're delayed and it's the first week of the third quarter? That's why we want to be careful. It's not our product, hasn't been transferred to us yet formally, so we don't have a better feel for the manufacturing of it just yet.

Blake Goodner - Bridger Management, LLC

Okay. And then the last question was just, I think it really relates to kind of a question that somebody else was asking. But just -- so if I -- maybe I could just break it down this way, just trying to understand the price and volume. You grew sales year-over-year by $41 million. And so I guess I'm just wondering, did the volume -- did volume contribute to that revenue increase year-over-year? Or was that all price? Can you maybe get us the breakdown? So, if you look at the revenue growth year-over-year, $41 million, how much of that was price versus volume in the quarter?

Martin P. Galvan

In the quarter, that was all price.

Blake Goodner - Bridger Management, LLC

So $41 million of price and volume was essentially 0?

Martin P. Galvan

Correct, in the quarter. And then for the year, I mean, for the year, we were up 81% for the year and about -- and 77% was price and the remaining 4% was volume.

Blake Goodner - Bridger Management, LLC

And the $100 million for next year -- basically, the $100 million of incremental revenues in the guidance going to -- call it, the high end of the guidance is $370 million versus $273 million?

Martin P. Galvan

Right.

Blake Goodner - Bridger Management, LLC

Can you break that down? How much of that is price versus volume in the guidance?

Martin P. Galvan

It's mostly price in the guidance. The -- it's not new price. It's essentially the annualization of price increase that we already implemented in fiscal 2014. There's some volume changes, there's some volume increases, but they're primarily -- they're offset primarily by the Digoxin volume decrease we've been discussing.

Operator

And our last question comes from Tom Bishop with BI Research.

Tom Bishop - BI Research

I ran through the guidance quickly and I came up with a number of $2.75 a share based on using 38 million shares. And I'm just wondering, am I way off? Did I miss something big? Or are you having another big year?

Martin P. Galvan

We're not prepared, I think, to comment on the specific EPS number. You're going to have to --

Tom Bishop - BI Research

There was nothing in other income or expense, really. There wasn't in the past. There's nothing in there now, is there?

Martin P. Galvan

That's correct. That's correct.

Tom Bishop - BI Research

Because you've given us guidance on almost every point up...

Martin P. Galvan

That's right.

Operator

We have no further questions at this time.

Arthur P. Bedrosian

Okay. Well, I'd like to thank you again for joining us today. We are always available to answer further questions and look forward to reporting on our continued progress on our next call. Thank you.

Operator

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.

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Source: Lannett's (LCI) CEO Arthur Bedrosian on Q4 2014 Results - Earnings Call Transcript

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