Aug 7, 2013
Executives
August J. Moretti - Chief Financial Officer and Senior Vice President James A.
Schoeneck - Chief Executive Officer, President and Director Michael Sweeney - Chief Medical Officer and Vice President of Research & Development Jack Anders
Analysts
Scott R. Henry - Roth Capital Partners, LLC, Research Division Jason N.
Butler - JMP Securities LLC, Research Division Jason Napodano - Zacks Investment Research Inc. James F.
Molloy - Janney Montgomery Scott LLC, Research Division John Rousmaniere Gordon - Deltec Asset Management, LLC
Operator
Good day, and welcome to the Depomed Second Quarter 2013 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded.
I would now like to turn the conference over to Mr. August Moretti, Chief Financial Officer and Senior Vice President.
Please go ahead, sir.
August J. Moretti
Thank you, operator. Good afternoon, everyone, and welcome to our Second Quarter 2013 Financial Results and Business Update Conference Call.
With me today are Jim Schoeneck, President and Chief Executive Officer of Depomed; Matt Gosling, Senior Vice President and General Counsel; Mike Sweeney, our Chief Medical Officer; and Jack Anders, Senior Director of Finance. I'd like to remind you that the matters discussed on this call will contain forward-looking statements that involve risks and uncertainties, including those relating to the commercialization of our 3 products, Gralise, Zipsor and Lazanda, and Glumetza and related intellectual property matters, as well as our projected revenue, expense and year-end cash for 2013.
Actual results may differ materially from the results predicted and reported results should not be considered an indication of future performance. These and other risk factors are more fully discussed in our annual report on Form 10-K and in our quarterly report on Form 10-Q that we will file with the SEC this week, most particularly under the caption Risk Factors.
Depomed disclaims any obligation to update or revise any forward-looking statement made on this call as a result of new information or future developments. And as a reminder, Depomed's policy is to provide financial guidance and guidance on corporate goals for the current fiscal year and to update or confirm its guidance only by issuing a press release or filing updated guidance with the SEC in a publicly accessible document or providing such information on a publicly available Investor Conference Call.
References to current cash, cash equivalents and investments are based upon balances as of June 30, 2013. All other guidance, including guidance relating to the company's expected revenues, expenses, year-end cash and corporate goals is as of today, August 7, 2013.
I'll now turn the call over to Jim Schoeneck.
James A. Schoeneck
Thanks, Augie, and thank you, all, for joining us today. We've been saying since last year that 2013 would be a breakthrough year for Depomed.
Today's milestone earnings report demonstrates that this year is shaping up as expected. Over the past few years, we have steadily been building towards profitability from our ongoing operations.
And in the second quarter 2013, we have accomplished that feat. We achieved an operating profit from ongoing operations for the first time in our history.
Yes, it's only $0.01 a share, but we believe we are well-positioned for continued top and bottom line growth, and we expect it will be the first of many profitable quarters. In the past, Depomed has accomplished profitable quarters and even profitable years as a result of our technology and development expertise, plus our astute deal making in licensing and related transactions.
For the second quarter 2013, we had net income of approximately $0.5 million. We were also cash flow positive for the quarter.
We had an excellent quarter on all fronts with total revenues of $30 million, 112% more than last year's second quarter. Product sales and royalties, both increased significantly year-over-year, while maintaining control of our operating expenses.
Operationally, Depomed continues to make excellent progress toward becoming a sustainably profitable growth oriented specialty pharmaceutical company. Last Monday, we announced 2 important developments that advanced the company and are the result of the great work that's built the foundation of the company and the commitment to growing the company through acquisition.
First, our partner, Mallinckrodt, announced acceptance of the NDA for MNK-795 with priority review. The product uses our Acuform technology licensed to Mallinckrodt in 2008.
The event triggers a $5 million milestone to Depomed and more importantly, could bring this drug to market by early 2014. Upon NDA approval, we will earn $10 million approval milestone and then receive high single-digit royalties on sales of the product.
Later that day, we announced the acquisition of Lazanda Nasal Spray, our fentanyl product for breakthrough cancer pain in opioid-tolerant adult patients that I'll discuss in more detail shortly. We believe our first quarter sales force realignment and other Gralise initiatives are having an impact.
Gralise product sales in the second quarter grew to $8.6 million. That's a 167% increase year-over-year and a 40% increase over first quarter of this year.
Prescriptions increased to 58,000, 15% over first quarter. Gralise tablet dispensed increased 17% over the first quarter so at a even higher rate than prescriptions.
This reflects an increase in the average size of a Gralise prescription. We continue to work diligently to expand our managed care coverage for Gralise, with a particular focus on Medicare Part D plans.
We also continue to prosecute our litigation against the 3 remaining Gralise ANDA filers over our 9 Orange Book patents for Gralise. In June, we had a Markman claim construction hearing.
We were pleased with the result with the hearing and expect a ruling sometime this quarter. As for orphan drug status on Gralise, we look forward to oral argument in our suit against the FDA and federal court in the District of Columbia later this month.
We expect a decision late this quarter or early next quarter. Our Zipsor net sales rebounded from $3 million in first quarter to $5.6 million in second quarter, an 83% increase.
In mid-June, we streamlined our flex sales force and redirected their efforts to focus on Zipsor. We have positioned 29 primarily part time representatives in parts of the country, we believe, represent the best potential to grow Zipsor.
This past week, we saw our highest Zipsor weekly prescription rates since October of last year, so the initiative appears to be off to a good start. The flex reps continue to sell Gralise to their prescriber audience as well.
In July, we filed suit against a Zipsor ANDA filer for infringement of our 5 Orange Book listed Zipsor patents. The patents provide IP protection to 2019 and 2029 and we intend to defend our IP vigorously.
When we revamped our Glumetza deal with Santarus 2 years ago, we said we thought the deal was win-win for both companies. Now 2 years later, I believe all would agree, the diabetes drug continues to produce for both companies and has exceeded our expectations.
Glumetza has grown from a $65 million run rate, prior to the change in deal structure, to over $175 million as of last quarter. Depomed receives 32% of that revenue in royalties.
Glumetza royalties for the quarter were $14.2 million compared to $9.4 million for the second quarter last year. On July 29, we announced our acquisition of all U.S.
and Canadian rights to Lazanda fentanyl Nasal Spray from Archimedes Pharma. Lazanda is the only product that delivers a scheduled controlled substance via nasal spray.
We believe nasal delivery may be a good option for breakthrough cancer pain patients, particularly those suffering from oral mucositis. Last week, we completed the transfer of the NDA for Lazanda to Depomed.
This week, we began shipping products and booking sales. We are confident that we can grow Lazanda revenues significantly.
The universe of prescribers is highly concentrated with approximately 2,000 prescribers accounting for 90% of the prescriptions for the transmucosal immediate release fentanyl or TIRF class. TIRF prescribers are required to enroll in a REMS programs, specifically designed for this class of drug.
There are approximately 8,000 physicians enrolled in the TIRF REMS program. Archimedes had been selling Lazanda in the U.S.
with 14 contract sales representatives focused primarily on oncologists. We plan to focus our initial Lazanda-selling efforts on the 2,000 top prescribers.
We are in the process of winding down the CSO contract for the Lazanda reps and establishing sales coverage directly from Depomed. We acquired Lazanda's 2 Orange Book listed patents that protect the product to 2018 and 2024 and there's no reported ANDA filing.
We expect to realize Lazanda revenue for the foreseeable future. We look forward to updating you on Lazanda developments and results in investor conferences and on future earning calls.
In summary, we are pleased with the growth in our product revenues, royalties, and the developments in our partner programs. We're excited to have achieved a profitable and cash flow positive quarter and to have closed our second product acquisition in the last 13 months.
I want to thank all the employees at Depomed for their hard work and dedication that have allowed us to achieve these milestones. I'll now turn the call back over to Augie to discuss our financial performance and then we will take questions after that discussion.
August J. Moretti
Thank you, Jim. I'm pleased to announce our second quarter 2013 financial results, which reflect a profitable and cash flow positive quarter and I believe position us for future growth.
Total revenues grew 112% for the second quarter of 2013 to $30 million compared to $14.1 million for the prior year quarter. As Jim mentioned, the increases were primarily a result of increases in Gralise product sales, the acquisition of Zipsor in June 2012 and increases in Glumetza royalties from Santarus.
Gralise product sales were $8.6 million for the second quarter of 2013 as compared to $3.2 million for the prior year quarter. Zipsor product sales in the second quarter of 2013 were $5.6 million compared to 0, obviously, for the prior year quarter as we acquired Zipsor in late June 2012.
Glumetza royalties were $14.2 million in the second quarter of 2013 as compared to $9.4 million in the prior year quarter. Selling, general and administrative expenses were $25.4 million in second quarter 2013 compared to $25 million in the prior year quarter.
Research and development expenses were $1.4 million in second quarter 2013 compared to $3.5 million in the prior year quarter. The decrease was largely due to the cessation of expenditure with regards to our SEFELSA product candidate after the FDA advisory committee vote in March of 2013 and the complete response letter that we received in May of 2013.
We were profitable in the second quarter with net income for second quarter of 2013 of approximately $500,000 or earnings of $0.01 per share compared to a net loss of $15.8 million or a loss of $0.28 per share in the second quarter of 2012. Cash, cash equivalents and marketable securities were $74.2 million as of June 30, 2013, and this represents an increase of approximately $1.3 million for the quarter.
Before providing revenue, expense and cash usage guidance for the remainder of the year, I'd like to point out that the guidance is based on our current budget and reflects the acquisition of Lazanda in late July and estimated Lazanda sales and marketing expenses for the remainder of this year. As you can appreciate, the budget is based on a large number of assumptions given the complexity and the scale of our business and the uncertainties in estimating future product and royalty revenue.
These assumptions may change substantially as the year progresses for any one of a number of reasons, some of which are in our control and some of which are not, specifically this guidance may change if we acquire or in-license any additional products during the remainder of this year. I would direct you to the Risk Factors section of our annual report on Form 10-K and our upcoming 10-Q filing for a more complete discussion of the relevant risks relating to our guidance.
With that said, we are updating the guidance provided on our call last week regarding the Lazanda acquisition. We expect total revenue to be in the range of $125 million to $135 million in 2013.
So that is not a change in the guidance. And this range includes the $5 million milestone related to the FDA's acceptance of Mallinckrodt's NDA for MNK-795 that we expect to receive and recognize as revenue during the third quarter of 2013.
We are reducing the range of operating expense from our previous guidance, which had been $120 million to $130 million for the year. We now expect operating expenses to be in the range of $118 million to $125 million, which includes approximately $4 million of intangible amortization related to Zipsor and the sales and marketing expense related to Lazanda for the remainder of the year.
We expect to end 2013 with $70 million to $80 million in cash, and we expect to achieve cash flow positive during the second half of the year. We have not reduced year end cash guidance as a result of the Lazanda acquisition and the upfront payment that we made there.
I'll now turn the call to Jim Schoeneck for concluding remarks.
James A. Schoeneck
Thanks, Augie. We believe the prospects for our business during the remainder of the year and beyond are excellent.
With 3 of our own marketed products, significant royalty and milestone income, a strong balance sheet and an expectation of continued positive cash flow operations in the second half of this year, we believe 2013 will be the landmark year we expected. And we continue to seek to acquire, license or co-promote marketed and late-stage differentiated assets that complement our existing areas of focus.
We look forward to updating you on our progress throughout the year. Thank you for your continued support.
And, operator, we'll now open the call to questions.
Operator
[Operator Instructions] Our first question will come from Scott Henry of Roth Capital.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
I guess, just a couple of questions. First, was there any stocking in the quarter or any price increases on your products?
James A. Schoeneck
So, Scott, last quarter we had talked about how the wholesalers had destocked some, they actually had continued on those lower levels. So we did not see any additional stocking of the drugs in the quarter.
As far as price increase, we did take 2 price increases toward the beginning of the quarter, one on Gralise and one on Zipsor.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Okay. But I think we already knew about those.
Okay. And then, a question on Lazanda.
I mean, you're talking about going after the 2,000 high prescribers that reached 90% of the scripts in that category. My question is, those 14 oncology reps that were in place already, were they already hitting any of those high prescribers?
What I'm wondering is are all of the high prescribers in the pain category or is there any risk of losing any of your base, that base $5 million in revenues that were covered on the oncology side?
James A. Schoeneck
So, Scotty, we certainly are looking at the current prescribers of Lazanda so that we can protect that business in addition for the opportunity to grow. So they were calling on some people as of earlier this year.
They were, I think, focused mainly on oncology through the end of last year. They made some shift towards some pain physicians earlier this year.
But we've got a keen handle on who those prescribers are and are making sure that we continue the coverage with them and at the same time, looking at how we expand the reach to that 2,000.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Okay. And then another question.
The research and development spending has, obviously, been declining for a little while now. At what point would you expect that to start picking up again?
And are there any updates on the Parkinson's disease program?
James A. Schoeneck
Why don't we handle the second part of the first? We've got Mike here on Parkinson's and then I can turn it over to Augie on the expense side for R&D.
Michael Sweeney
Scott, we presented the results of the premier meeting of the Movement Disorder Society, we were actually selected as a blue ribbon presentation and it was very well received. We are looking at the feedback that we had.
We have a number of a minor issues to discuss with the FDA, which we'll hope to do by the end of the year and make decision on the progress thereafter.
August J. Moretti
And with respect to expense levels, I think it's very much dependent upon what actions we take with respect to the Parkinson's program in terms of moving that forward.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Okay. And final question.
Just to jump back to Gralise. If you're looking at the prescriptions, they really took off in the spring and it seemed like the trends has flattened out a little bit here in the summer.
Any thoughts on that? Is it seasonality?
Do you expect it to start to reramp soon? I just wanted to get any color there.
James A. Schoeneck
Yes. So, Scott, I think what we've seen is that the entire market on the gabapentin side and gabapentin-related compounds has come down the last 2 or 3 weeks.
We've actually increased our share over the last 3 or 4 weeks, even though prescriptions have been basically flat. So as the market picks back up, and this market tends to pick back up in either August or September, I'd expect to see a receleration of those script numbers.
Operator
Our next question will come from Jason Butler of JMP Securities.
Jason N. Butler - JMP Securities LLC, Research Division
Maybe I can start by just following up on the last question on Gralise. You talked about the slight sales force realignment with some more of the flex reps spending more time on Zipsor.
Do you have any view that that's going to impact the Gralise growth curve right now? Does that detract any way from your efforts with Gralise?
James A. Schoeneck
Jason, we actually don't believe that it will. I mean, we've been monitoring that group pretty closely and they continue to increase Gralise prescriptions and the docs they're calling on.
We just thought there was an opportunity to push even farther with Zipsor, particularly since that group is mostly calling on primary care.
Jason N. Butler - JMP Securities LLC, Research Division
Okay, great. And then on the Medicare contract for 2014, is there any visibility into those negotiations right now or any time frame for getting visibility?
James A. Schoeneck
Yes, still continuing. CMS is actually a little bit behind this year on some of the stuff getting finalized.
So we're normally by mid-August, I'd expect it to be about set for 2014. I still think we're still probably 30 to 45 days away from that.
Jason N. Butler - JMP Securities LLC, Research Division
Okay, great. And then just the last question for Augie, just on -- as you move into a state of sustained profitability, can you help us on how we should think about your tax rate for the rest of '13 and then going into '14 and '15, both on a cash basis and on a GAAP basis?
August J. Moretti
Well, certainly, in terms of applying our NOLs without having budgeted next year, my assumption is that we will be able to apply our NOLs toward -- for any profitability that we show this year and profitability that we might show next year. So we would expect to start paying taxes in 2015.
Today -- and again, the application would be first NOLs and then R&D credits applied to applicable tax. And so I don't see us being -- paying taxes until 2015.
We do not have in place today a strategy to reduce our marginal tax rate. And so that's, obviously, that's something that we can think about as we proceed through '14 and into '15.
James A. Schoeneck
And, Jason, I think on the GAAP part of the question, I mean, we will continue to monitor what we believe the profitability going forward to be. And then we'll do the analytics we need to do on recognition of the NOL at some point in time.
Operator
The next question will come from Jason Napodano of Zacks.
Jason Napodano - Zacks Investment Research Inc.
So I've got just kind of a big-picture question, if you'll entertain me. The company was built on Acuform.
The key product in Gralise is based on Acuform. The royalties are derived from primarily Acuform and licensing.
But the recent acquisitions of Zipsor and Lazanda kind of separate that. And now, you've got 2 distinct drugs that have nothing to do with Acuform.
So you look at the earnings report here for the second quarter, you're not doing a whole lot of internal R&D. So my question is, as you're making this transition from an R&D company that was once based on Acuform to this pain-focused specialty pharma company, do you think that you have to get a lot more aggressive in terms of in-licensing and acquiring drugs like Zipsor, like Lazanda?
Or are you comfortable with where you are now, let's say, from a commercial standpoint and think that at some point, you may ramp back up that R&D so that you can kind of get back to the royalties or the out-licensing potential?
James A. Schoeneck
Yes. So there's obviously, a number of threads in that.
I think first, I would characterize that we will continue our aggressive posture on in-licensing and looking for acquisitions. So I don't think we need to ramp it up, I think we'll continue to do it.
And the fact that we've done 2 in 13 months when a lot of other people in our position talked about it but never execute one, I think, is probably our best example of that. In terms of the R&D piece, I think, one, we want to get to where we are generating cash.
We obviously, will then look for ways to invest that cash in acquisition. And perhaps at some point, look for things that are more in the pipeline stage.
I mean, at this point, not ready to declare if or when that would be, but that's how we'll look at going forward as we look to build value over the longer-term.
Jason Napodano - Zacks Investment Research Inc.
Maybe, Jim, you can give us a sense and if you don't want to get too specific, I think we'll understand, but maybe you give us a sense of how long ago you started to look at Lazanda, how many drugs you looked up and maybe passed before you decided on Lazanda? And if drugs like Zipsor and Lazanda are still out there and plentiful enough and cheap enough or, let's say, cost-effective enough, for a company like Depomed that you think you can continue to kind of build your commercial assets one at a time like maybe one every year like you've been doing?
James A. Schoeneck
So one, in terms of the timetable on bus dev, I actually never give those because it's just -- it's too hard when you've got parties on both ends that have to agree. In terms of opportunity, we continue to believe that there is opportunity for both product acquisition and potentially, at some point here, for consolidation as you got a number of companies that are out there that are single-product companies.
In terms of the -- piece in terms of where we may focus some of that, I think the -- how we focus it -- our team, I've mentioned this before, never comes to me and goes, well, jeez, what do you want us to do today, Jim? It's always help us prioritize because they've got so many things that they're looking at.
So we crank quite a few things through and I think with that, you can assume that we take things on a normal attrition rate through to where we get other things, the term sheet and for whatever reason, decide not to move ahead with it. So again, it tends -- it continues to be a prime effort for us and also continues to be very busy in that group.
Operator
Our next question will come from Jim Molloy of Janney.
James F. Molloy - Janney Montgomery Scott LLC, Research Division
On sort of the next acquisition, I noticed you said -- just mentioned the timing of that's hard to pin down. I certainly understand that.
Is Lazanda-type acquisitions what we should be looking for coming forward -- going forward or more like a Zipsor a little bit on the bigger side?
James A. Schoeneck
I think it's a range. I think, what we said before, we would look at things that were kind of at a lower end, in that $4 million, $5 million range up to things that were significantly more than that.
I mean, up to triple digits. So we look across that full range and look at what we think can be the best opportunity for us to bring things in, produce value to the shareholders and to grow.
And really, that's where we feel like Lazanda fits in. And if we really only thought the drug could do about what it's doing now, it probably wouldn't be very interesting.
But we really believe that there's an opportunity to grow it significantly.
James F. Molloy - Janney Montgomery Scott LLC, Research Division
Is there any reason to think that towards the triple-digit acquisition is something that's next on the plate or is there anyway to handicap what made you go in that?
James A. Schoeneck
No. I'd just -- all I'll say is it's in that range that we look and the higher up you go in that range, the more you get competition from bigger players.
So that gets a little more difficult as well. But we look across that whole spectrum to see what we can then shake loose and bring in.
James F. Molloy - Janney Montgomery Scott LLC, Research Division
And then on the R&D, it's certainly dramatically -- I mean, it hasn't been going down, but it's dramatically lower here in the quarter. And is this a sustainable level going forward?
Or any concerns about sort of cutting muscle along with fat from the group at these low levels?
August J. Moretti
Jim, this is Augie. I would say, again, in terms of increasing the R&D spend in the near term, it's principally a function of what we decide to do with the Parkinson's program.
James A. Schoeneck
And anything we might license in, that would be at the R&D piece. The other just reminder on that is if there's any work that we're doing that's on one of the drugs that's already approved, that gets accounted for in SG&A, not on the R&D side.
So it doesn't mean we don't have things going on. It just means that it's not on drugs that are not yet approved.
James F. Molloy - Janney Montgomery Scott LLC, Research Division
Okay. And a final question.
I know that with Zipsor you're able to take some pretty dramatic price increases right off the bat, something similar for Lazanda?
James A. Schoeneck
At this point, Jim, we haven't declared one way or the other on that. So we continue to analyze it as we would with any of our compounds.
Operator
[Operator Instructions] The next question will come from John Gordon of Deltec Asset Management.
John Rousmaniere Gordon - Deltec Asset Management, LLC
Most of my questions have been answered, but just a couple of follow-ons. The first is as it relates to Lazanda, was that on your radar scope and you approached them?
Or that was an incoming phone call to you that actually originated the transaction?
James A. Schoeneck
I think, John, we look really broadly at what our audience prescribers are writing. We look for any of the adjacencies around that.
And so we've got a very broad look in terms of what's out there and then trying to determine, one, if we want it and then second, do we think we can shake it loose. So I'd rather not get into the specifics about who approached whom.
But I can tell you that we do take a very broad look at it and reach out to lots of people.
John Rousmaniere Gordon - Deltec Asset Management, LLC
So regardless of whether it was an incoming phone call or an outgoing phone call on Lazanda, I take it from what you just said, Jim, that your degree of scrutiny of what's available is sufficiently comprehensive that it would uncover a Lazanda-sized transaction?
James A. Schoeneck
We do screens on this regularly, John, both in terms of the areas that we're interested in and also the size products. So -- and it really is around what do our key physicians write.
And so we just continually update those type of metrics and then decide what we think is most interesting.
John Rousmaniere Gordon - Deltec Asset Management, LLC
Okay. And, Jim, has the headcount stayed stable over the last 3 months or has there been any change one way or the other that we should know about?
James A. Schoeneck
No. I think we've been right in about the same ballpark other than what we did with the flex reps, John, where we went from -- and those actually weren't on our technical headcount because those were all contracted.
But we did go from 78 flex sales representatives down to 29 people that are now in that sales force. So that's the only thing really significant on the headcount side, was really just focusing that group.
Operator
The next question will come from Scott Henry of Roth Capital.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Just a quick question. COGS, cost of goods sold, looked a little bit light in the quarter relative to the sales increase.
Any thoughts on that percentage there? I mean, was it low variance quarter?
Or is that a sustainable number?
James A. Schoeneck
So I'll jump in at the very top line on it, Scott, and then I'll let Jack jump in post that. We had mentioned that when we bought Zipsor, that we had to mark the inventory up above what the actual production cost of goods was and carrying it at that level.
We now have burned through that material, have shipped that material. And so we now have gone to what we will see as a more ongoing cost of goods on Zipsor.
I will say that in addition, we'll see that same type of thing we would expect as we do the accounting upfront on Lazanda. So we would see a pop, perhaps, because of Lazanda.
But in terms of release in Zipsor, I think, what you're seeing is probably what you'll get for the future, at least in that general range. Jack, anything specifically you want to add?
Jack Anders
Scott, this is Jack. In terms of -- with regards to Zipsor, the last of the marked up shipments went out in early May.
And so we had a partial quarter where we saw that the marked-up shipments going out. With regards to Lazanda, we're still working to the accounting on that and we'll provide a little bit more clarity on the next earnings call with respect to if there is an inventory markup there.
James A. Schoeneck
Well, I want to thank you all of you for your interest in Depomed and for following us, some of you for over a number of years. We are very happy to be able to deliver these results to you today and hope to be able to continue good news as we get to our next quarterly call on the upcoming investor conferences.
So thank you, again, for your interest, to your support, and we look forward to talking with you in the future.
Operator
Ladies and gentlemen, the conference has now concluded. We thank you for attending today's presentation.
You may now disconnect your lines.