Timothy P. Walbert – President, Chairman and CEO
Robert J. De Vaere – Executive Vice President and CFO
Todd N. Smith – Executive Vice President and CCO
Lisa Bayko - JMP Securities
Daniel Chang - Stifel Nicolaus
Horizon Pharma, Inc. (HZNP) Q3 2012 Earnings Conference Call November 13, 2012 8:00 AM ET
Good morning everyone and welcome to the Horizon Pharma Third Quarter 2012 Financial Results Conference Call. This call is being recorded. At this time for opening remarks and introduction, I would like to turn the call over to Horizon Pharma’s Chief Financial Officer, Mr. Bob De Vaere. Mr. De Vaere, Please go ahead sir.
Robert De Vaere
Thank you. Good morning, and welcome to Horizon Pharma’s third quarter earnings call. This morning we issued a press release that provides the details of the company’s financial results for the third quarter ended September 30, 2012, as well as an update on DUEXIS and RAYOS and other recent business highlights. This press release is available on our website at www.HorizonPharma.com.
Leading the call today will be Tim Walbert, Chairman and President and Chief Executive Officer of Horizon Pharma. Tim will provide a corporate update. Todd Smith, Executive Vice President and Chief Commercial Officer will provide an overview on the commercial launch of DUEXIS and prelaunch activities for RAYOS. And I will provide an overview of the financial highlights from the third quarter before turning the call back over to Tim for closing remarks.
As a reminder during today’s call, we will be making certain forward-looking statements. These statements may include statements regarding our financial outlook, our sales and marketing plans, potential growth of our business and plans to enter into future commercial agreement. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These risks are described in our filings made with the Securities and Exchange Commission including our Annual Report on Form 10-K for the year ended December 31, 2011 and subsequent quarterly reports on Form-10-Q. You are cautioned not to place undue reliance on these forward-looking statements and Horizon disclaims any obligations to update such statements. Further, we may also discuss non-GAAP financial measures during this call to help you understand our underlying business performance. The GAAP reconciliations are provided in our press release which was posted on our corporate website www.HorizonPharma.com.
I will now turn the call over to Tim.
Thank you Bob, and thank you to everyone for joining us on the call today. Horizon has continued to make substantial progress since our last call. And today I will summarize the recent developments in our business, particularly with the promotion of DUEXIS in the U.S. U.S.FDA approval of RAYOS in a broad range of indications, and securing approximately $81 million in a public follow-on offering in June.
The capital raise during third quarter further strengthens our financial position and allows us to focus our efforts on the ongoing commercialization of DUEXIS and the launch of RAYOS in the U.S. We expect that this recent offering along with our existing cash resources will fund our operations through 2013.
We are pleased with the third quarter performance of DUEXIS which showed a steady increase in sales and prescription demand. This increase was driven primarily by our 80 sales representatives, who only covered about 10,000 physicians who collectively represented about 8% of the NSAID market prescriptions in the U.S.
DUEXIS net sales for the third quarter were $2.6 million, an increase of 63% versus second quarter of 2012. According to monthly data from Source Healthcare Analytics formerly Wolters Kluwer, total prescriptions in the third quarter of 2012 for DUEXIS were over 25,000, an increase of 33% versus the second quarter of 2012. Total DUEXIS monthly prescriptions for the month of September were 9,282, an increase of 10% versus August 2012 and an increase of 33% versus August 2012, when normalizing for selling days per month. Also, at the end of September, more than 6,500 physicians have written prescriptions for DUEXIS since we launched the product.
Although, we had strong sequential DUEXIS growth in the third quarter, we did not have the critical mass of DUEXIS promotions to drive revenue growth needed to meet our long term goals. As a result, we underwent a planned significant expansion of our sales force in the third quarter and completed co-promotion agreement with Mallinckrodt, the pharmaceutical business of Covidien. In late September, we completed our sales force expansion increasing from 80 to approximately a 150 representatives. This expansion along with our co-promotion agreement with Mallinckrodt allows us to significantly increase our reach and frequency of promotion for DUEXIS.
Our strategy is for our 150 sales representatives to call in 25,000 high value NSAID prescribers and for Mallinckrodt to promote DUEXIS to another 25,000 exclusive physician targets. We believe that Mallinckrodt’s expertise in the distribution of pain therapeutics along with their experienced sales force in the osteoarthritis and pain markets is well suited to successfully market DUEXIS to their exclusive target.
As a result of our combined promotional effort on October 1, we increased to call on physician targets for DUEXIS five-fold from 10,000 to 50,000. These 50,000 targets now make up over 50% of the NSAID prescription market which we feel is a critical mass needed to drive DUEXIS revenues moving forward. As a reminder, we will record all revenues for DUEXIS under the Mallinckrodt agreement and will remain responsible for DUEXIS manufacturing, supply, and regulatory activities while Mallinckrodt will receive compensation based on prescriptions generated by their sales efforts against their exclusive targets, which we will record in sales and marketing expenses.
I would now like to discuss early results of our expanded efforts since October 1. In the week ending October 26, we hit a new all time weekly prescription high of 2,884 prescriptions for DUEXIS, an increase of 6.1% over the prior week and 4 weeks sequential total prescription growth of approximately 20% and new prescription growth of 23%. I would like to note we expect prescriptions to temporarily go down for the week ending November 2 due to the devastating effect of Sandy in many East Coast states.
Now, I would like to provide an update on RAYOS. RAYOS was approved on July 26 with a broader range of indications than we anticipated allowing for potential sales on a wide range of inflammatory diseases. In addition to rheumatoid arthritis and polymyalgia rheumatica RAYOS is approved for the treatment of 79 incremental indications including psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease. Our primary efforts during the launch will focus on rheumatologic diseases such as rheumatoid arthritis and polymyalgia rheumatica, but given this broad range of approved indications we are working to develop a broader commercial strategy to expand the opportunity for RAYOS in key IL-6 mediated diseases such as asthma and COPD.
Yesterday, we initiated promotion of RAYOS for rheumatoid arthritis, polymyalgia rheumatica and other rheumatologic diseases to rheumatologists attending the American College of Rheumatology Annual Meeting in Washington DC. This meeting typically attracts approximately 14,000 rheumatologists and other rheumatology healthcare professionals from around the world.
We estimate that approximately 60% to 70% of potentially U.S. rheumatology prescribers for RAYOS attend this meeting. Between now and late January 13, we’ll be promoting RAYOS to over 1000 high value rheumatologists in the United States. In late January, we plan to launch RAYOS with our full sales force to the majority of the U.S. rheumatologists and key primary care physicians. In addition to our outreach to the rheumatologists during the ACR meeting, yesterday we hosted an investor briefing to discuss the approval and the initial launch of RAYOS with presentations from leading rheumatologists Dr. Maurizio Cutolo of the University of Genova and current president elect of EULAR, Dr. Frank Buttgereit of the Charité at the University of Berlin and lead investigator of the RAYOS phase III program, and Dr. Art Weaver of the University of Nebraska who’s past president of the American College of Rheumatology. If you are unable to attend or view the meeting real time, I invite you to visit our website to access the presentations and listen to the webcast replay.
In addition to the promotional activities of RAYOS during the ACR Conference, there were two RAYOS abstracts presented during the meeting. Data presented by Dr. Rieke Alten Chief of Internal Medicine in Berlin concluded that based on the CAPRA II trial data of RAYOS, RAYOS helped treat RA patient’s inflammation as well as improved patient’s symptoms specifically the fatigue that many patients with RA experience. The second abstract of data from the CAPRA II study presented by Dr. Buttgereit demonstrated that morning stiffness duration, morning stiffness severity and pain intensity upon awakening correlated with disease activity score and helped assessment questionnaire disability index in all treatment group analyses.
In addition, patients who met ACR 20 response criteria, DAS 28 response criteria and the [HACC] [ph] disability index response criteria at a greater relative reduction of morning stiffness than patients who do not meet these criteria. Most importantly more patients treated with RAYOS met this response criteria than those in the controlled group. Outside the U.S RAYOS is known as LODOTRA and is approved in 19 countries.
LODOTRA’s marketed in Europe through our distribution partner Mundipharma who also has commercial rights in certain Asia and Latin America country. Today, we reported third quarter net revenue of 3.9 million for LODOTRA and 9-month net revenue of 7.8 million. Before, I turn the call over to Todd, I would like to highlight developments we previously announced regarding our commitment to our intellectual property estate for both DUEXIS and RAYOS.
In September, we announced an important expansion of the DUEXIS patent estate with two additional notice of allowances from the U.S. Patent and Trademark Office, both entitled to stable compositions of famotidine and ibuprofen with claims covering DUEXIS tablets. In addition, we received the critical expansion of the patent estate for RAYOS. On October 15, we announced our collaborator SkyePharma received the notice of allowance from the U.S. Patent and Trademark Office entitled, ‘The late release tablet with defined core geometry.’
These notice of allowances are significant step to closer to achieving our goals protect the commercial potential of DUEXIS up to 2028 and RAYOS out to 2024. At this point, I will turn the call over to Todd Smith, who will discuss our commercial highlights for the quarter.
Thank you Tim. Good morning everyone and thank you for joining us today. Let me start by saying that as we expand our sales efforts and achieve the critical mass that Tim spoke about earlier in the call, we continue to make significant progress in executing an impactful launch for DUEXIS. While we are still in the early stage in the commercialization of DUEXIS, I’m pleased to share with you our recent progress.
According to monthly data from Source Healthcare Analytics through September 30, 2012 there have been approximately 55,000 total prescriptions for DUEXIS, since the launch, with over 25,000 in the third quarter alone, that’s n increase to 33% versus the second quarter. As of September 30, there were 6500 cumulative devices prescribers, that’s an increase of approximately 60% versus June 30, 2012. And our sales forces added over a 150 new prescribing health care professionals per week during the third quarter, and over 200 new prescribers per week in the month of September.
Further 45% of physicians we’ve detailed frequently which we define as more than 6 calls since we began calling on them have started prescribing DUEXIS. So, given this strong foundation of prescribers, our focus is turned to converting trail into adoption. And as a result, the number of physicians we have in adoption, which is any prescriber that is writing 5 or more DUEXIS scripts a week, has increased 86% since June 30, 2012.
So, in addition to that, our market research continues to show that approximately 85% of commercialized have access to DUEXIS with approximately 80% of DUEXIS commercial claims having a patient out of pocket cost of $25 or less. And this is due to the implementation of our co-pay assistance program.
As anticipated in any product launch we’ve identified areas in which we have increased our focus. Of late it is becoming common among pharmacies throughout the healthcare system in the United States is that pharmacists switching patients prescription to a generic or over-the-counter brands. This practice is a result of how pharmacies are incentivized. There is a concern because patients are not receiving the prescribed medication that their physicians intended.
Our sales representatives have begun to work closely with physicians and their staff to make them aware of this recent practice. So, we are addressing this in several ways. First, the profile of the representatives we hire has changed. We focused on hiring representatives with a successful business-to-business sales background versus those who have solely come from a pharma background. This is critical as we involve our promotional efforts from selling to physicians alone to selling to the entire office staff responsible for a patient getting a prescription. So our expanded sales team is aggressively focusing on this total office call.
Too often, a member of the office staff allows pharmacists to switch products without understanding why the physician wrote that product. Once a prescription is written, our representatives are focused on ensuring the office staff understands the benefits of DUEXIS and why they need to make sure patients get that prescription that doctor wrote.
In addition, we are piloting several programs to ensure patients have access to DUEXIS. One of them is an initiative to local and regional specialty pharmacies that allows DUEXIS to be shipped directly to the patient. Thereby ensuring patients get the prescription their doctor indented them to receive. We’ve piloted this strategy in several stage with encouraging initial results.
Lastly, I would like to speak briefly regarding our sales force expansion. As Tim mentioned, we now 150 representatives selling DUEXIS and soon to be selling RAYOS. With our sales force expansion and co-promotion agreement with Mallinckrodt, we believe we now have critical mass of DUEXIS promotion. We’re now targeting over 50% of the non-steroidal prescriptions by calling on 50,000 targeted physicians. I’m encouraged by the initial feedback from our sales force and from the Covidien sales force. Physicians understand the benefits of DUEXIS and we think we now have the right sized combine sales up to drive significant growth. The most recent four week total prescription growth of DUEXIS through the week ending in October 26, was 20% with the four week new prescription growth of over 23%. With the RAYOS launch, our focus in now on top 15 leaders[ph] and prescribers of products to treat Rheumatologic diseases. We have 13 of our representatives launching RAYOS to over a 1000 Rheumatologists starting at the ACR meeting taking place this week.
From a messaging standpoint we’re focused on the key benefit of RAYOS, which is the treatment of symptoms of RA and PMR which are at their worst in the morning. A pivotal trial on RA demonstrated statistically significant impact and both the primary endpoint of ACR 20 as well as the secondary endpoint of duration of morning stiffness. 94% of patients on RA therapy including standard prednisone still complain of morning symptoms with rheumatoid arthritis. Our goal is to position RAYOS as the rheumatoid arthritis therapy that allows patients to have less pain and stiffness in the morning and provide significant improvement in the quality of life. So, from a managed care standpoint, we’ve already had over 35 clinical presentations that managed care with positive relief feedback. We expect similar coverage of RAYOS as we have with DUEXIS in commercial payers. We also planned to ensure patients could access to RAYOS providing a plan to make sure that out of pocket expenses are manageable. Our goal is that patients averaged out of pocket cost will be below $25 per month. So, moving forward our broader sales effort remains focused on driving DUEXIS and we will launch RAYOS to majority of rheumatologists and our called on primary care physician in late January. Thank you for your time this morning and I will return the call over to Bob.
Robert De Vaere
Thanks Todd. First let me remind everyone that in December, the company began recognizing revenues from the sale of DUEXIS following its commercial launch in the U.S. DUEXIS has currently sold to wholesale pharmaceutical distributors and to several national and regional retail chains. Until the company can reliably estimate returns, the company is determined that shipment of products to wholesale distributors and retail chains do not meet the criteria for revenue recognition at the time of shipment. And we are currently deferring DUEXIS revenue recognition until the right of return no longer exists, which is the earlier of DUEXIS being dispensed through patient prescriptions or the expiration of the right of return. As of September 30, 2012 the company has 1.4 million in differed revenue on its balance sheet related to DUEXIS shipments. For the third quarter ending September 30, 2012, growth in net sales were 7.3 million and 6.5 million respectively compared to $0.3 million in both gross and net sales for the third quarter of 2011. DUEXIS gross sales were $3 million and net sales were $2.6 million after deducting trade discounts and allowances of $0.1 million and co-pay assistance costs of $0.3 million, and represented 41% of gross sales and 40% of net sales during the quarter ended September 30, 2012. Quarter-over-quarter growth in DUEXIS net sales was 63%.
LODOTRA gross sales were $4.3 million and net sales were $3.9 million after deducting trade discounts and allowances of $0.4 million during the quarter ended September 30, 2012.
Net loss for the quarter ended September 30, 2012, was $17 million, or $0.47 per share based on approximately 36 million weighted average shares outstanding, compared to a net loss of $17.2 million, or $1.30 per share based on 13.3 million weighted average shares outstanding, in the quarter ended September 30, 2011. The results for the third quarter ended September 30, 2012, include a one-time tax benefit of $4.3 million related to approval of RAYOS in July 2012. The approval resulted in a reclassification and amortization of certain intangible assets and an assessment of the company's deferred tax positions resulting in a reduction of current valuation allowances and recognition of a one-time net income tax benefit.
Non-GAAP net loss for the quarter ended September 30, 2012, was $13.9 million, or $0.39 per share, compared to a non-GAAP net loss of $15.6 million, or $1.18 per share, in the third quarter of 2011. Horizon provides non-GAAP financial measures, which it believes can enhance an overall understanding of Horizon's financial performance when considered together with GAAP figures. Please refer to the section of today’s press release entitled “Note Regarding Use of Non-GAAP Financial Measures" for a full discussion on this subject.
Research and development expenses decreased $1.5 million, from $5.3 million during the three months ended September 30, 2011, to $3.8 million during the three months ended September 30, 2012. The decrease in research and development expenses during the current period was primarily associated with a $1.9 million reduction in regulatory submission fees and clinical trial expenses and a $0.3 million reduction in consulting fees, which was partially offset by a $0.7 million increase in salaries and benefits expense as a result of additional staffing and personnel expenses, primarily related to staffing the company's medical affairs group which supports scientific publications, health outcomes, medical education and information and medical communications.
Sales and marketing expenses during the current quarter increased $7.9 million, from $5.1 million during the three months ended September 30, 2011, to $13 million during the three months ended September 30, 2012. The increase in expense was primarily attributable to ongoing sales and promotional efforts related to the company's DUEXIS product launch and pre-launch activities of RAYOS, which included a $4.8 million increase in salaries and benefits expense associated with staffing of the company's sales and marketing functions, including the company's sales force expansion, a $2.1 million increase in market research and marketing programs and a $1 million increase in consulting and outside service costs.
General and administrative expenses increased $0.5 million, from $4.2 million during the three months ended September 30, 2011, to $4.7 million during the three months ended September 30, 2012. The increase in general and administrative expenses was primarily due to a $0.4 million increase in salaries and benefits expense associated with an increase in finance and administrative personnel and stock-based compensation expense, a $0.3 million increase in legal costs associated with intellectual property related matters and a $0.2 million increase in facility costs associated with higher rent and insurance costs, partially offset by a $0.4 million reduction in consulting expenses during the third quarter of 2012.
Interest expense increased $2.3 million during the 2012 period, from $1 million during the three months ended September 30, 2011, to $3.3 million during the three months ended September 30, 2012, primarily as a result of incremental interest expense associated with higher borrowing balances under the company's senior secured loan. After completing our equity offering late in the third quarter, the company had cash and cash equivalents of $121.3 million at September 30, 2012, which we expect will fund our operations through 2013.
Now, I would like to turn the call back over to Tim for some closing comments.
Thank you, Bob. In summary, I believe we are well positioned to accelerate to excess revenue and launch real successively over the coming quarters. Initial prescription growth post our sales force expansion and the Mallinckrodt co-promotion DUEXIS is very encouraging.
Over the last year, we have established ourselves as a fully integrated commercial company with two new product launches and a strong balance sheet that has laid the groundwork to position the company for a success. From a broader corporate perspective, we continue to look to leverage our existing infrastructure. We are actively evaluating opportunities to co-promote, acquire or in-license additional products.
In the near term, our focus remains on successfully executing on the launch and commercialization of both DUEXIS and RAYOS. Thank you for joining us today, and at this time, we will open up the call for Q&A.
(Operator Instructions) Our first question comes from Lisa Bayko of JMP Securities. Your line is open.
Lisa Bayko - JMP Securities
Hi, congratulations on your launch and on the quarter. I just want to ask about reimbursements for RAYOS. Can you maybe talk about any initial progress you have had, how conversations are going and how – what the patients will pay for when they get a prescription from you? Thanks.
Hi Lisa. Thanks for the questions. So, as Todd mentioned, we have had 35 meetings with the various mixture of national and regional managed care accounts, and they’ve gone quite well. There have been scientific presentations to help the managed care organizations understand the benefits of RAYOS. As far as expectations, we expect to primarily focus initially on commercial [lives] [ph] where we would expect to be placed into Tier 3, which puts the patient in the general area of having about a $40 to $50 co-pay. As we have done with DUEXIS, we plan to bring that co-pay down to about an average of $25 for the patient. So, the typical out-of-pocket we would expect for a patient is about $25. So, again, we expect to be in a Tier 3 position in the majority of the accounts, as well as having that plan in place to ensure patients are getting RAYOS at a reasonable out-of-pocket costs similar to what we have done with DUEXIS.
Lisa Bayko - JMP Securities
Okay. In terms of you have had these meetings, when will they convert do you think to actually getting on formulary on that, you know, (inaudible)?
It’s less about getting on formulary and more about ensuring access. We expect, at the time of launch, to have a significant amount of RAYOS in the Tier 3 position. Typically in most accounts, you will initially be put into Tier 3 and then go through clinical reviews and P&T reviews over the first six months into the launch. So, we expect initially to have very good access in Tier 3. We don’t have a percentage yet, because we haven’t introduced the product and gotten some of that direct feedback, we expect to have very good initial access in Tier 3, and over the next several months, we will get a better understanding of what that actual co-pay looks like to a patient and how the overall managed care landscape looks like. But we feel very good about where we are at this point in time.
Lisa Bayko - JMP Securities
(Operator Instructions) Our next question comes from Annabel Samimy of Stifel Nicolaus. Your line is open.
Daniel Chang - Stifel Nicolaus
Hi, this is Daniel Chang in for Annabel. Thanks very much for taking the call. I had a few questions here. I guess firstly just going – I guess diving into the generic switching, have you guys been able to quantify the potential impact of sort of this new strategy of selling to the entire office staff and when might we be able to see some of the updates and results from that?
Thanks Daniel, for the questions. It’s Tim. I think we have already started to see the benefit of that. We saw a very strong growth in the month of September versus August. We had new prescriptions of 18% and total prescriptions of 16% and that was still with our existing 80% sales force. And that sales force was, about half of it was new representatives that we brought in over the summer, which has more business-to-business experience and are really focused on driving that full office call to educate, not only physicians that write but office staff to ensure that the patients get the product their physician intended. So, we did see strong acceleration in late August and into September, which is really what we view as results of that renewed focus on really ensuring that the prescription gets pulled through all the way from the physician to the patient picking it up at the pharmacy level.
The acceleration in October, we have seen more results of increasing that critical mass, through that critical mass five-fold increase in called-on physician targets, but we are already starting to see that benefit. We have also the added benefit, with the Mallinckrodt sales force that is calling on 25,000 exclusive targets that also has that same focus of understanding that you need to protect the prescription, ensure that the office staff doesn’t allow this pharmacy switching. So, we have already seen initial benefits and we expect that to continue.
Daniel Chang - Stifel Nicolaus
Great. And then, as far as the pilot program is concerned, it sounds like a third-party mailer to pharmacy. At what point do you sort of evaluate whether you want to take this to the next level and blow it up to a full scale national strategy?
So, relative to that program, we have piloted in five states with encouraging results. We are going to evaluate it over the next several weeks, but our plan would be to roll that out fully by the beginning of the year.
Daniel Chang - Stifel Nicolaus
Okay, great. And going on RAYOS, I think you talked yesterday about the promotion for the primary care versus the rheumatologists. Can you just talk about – do you anticipate having the same promotional strategy within the two physician segments and can you talk about what your expected uptake will be once you have the full launch in late January?
Our approach among rheumatologists will be to promote RAYOS in a primary physician and DUEXIS in a secondary physician. When it comes to our over 20,000 primary care targets, we will promote DUEXIS in a primary physician and RAYOS in a secondary physician. And as we said, we will be focusing with RAYOS in the short term with about 1,000 key opinion leaders, rheumatologists over the next several months, with the full launch in late January to ensure that we have got the right preparation, feedback to do the broader launch late January.
We are not commenting at this point on guidance relative to forward-looking prescriptions, but we are able to cover over 90% of all rheumatology prescriptions for products such as methotrexate and generic prednisone with our sales force. So, we are very encouraged by the fact that we have got critical mass right from the start with the launch of RAYOS.
Daniel Chang - Stifel Nicolaus
Great. And then, a couple of financial questions. As far as the deferred revenues are concerned, I think you had about $8.8 million in the quarter. Can you talk about what your expectations are for recognizing those revenues? And then secondly, can you just give us an update on the debt situation after the recent capital raise?
I will take the debt question, Bob, you can take the first one. So, we have a little over $60 million in debt, I think about $61 million with accrued interest and Bob, you can take the first question.
Robert De Vaere
Yes. So, at the end of the third quarter, we had in DUEXIS deferred revenue of about $1.4 million. We are still only about nine or 10 months into the launch of DUEXIS, and there is no bright line for when we would be able to flip that over and recognize revenue on sell-in rather than sell-through. We are certainly working, gathering data and working and refining our estimates of returns and things like that, which there haven’t been much of to be honest. So, there is no bright line on when we can flip that over, but we are certainly working to provide support and to make an argument that we should be able to do that sooner rather than later, but at this time, we don’t have an estimate of when that will happen.
Daniel Chang - Stifel Nicolaus
Okay, thanks very much.
Thank you. I am showing no further questions in the queue at this time. I will hand the call back to Tim for closing remarks.
Thank you very much for joining us on the call today. Feel free to reach out to the company if you have further questions, and have a great day. Thanks so much.
Thank you. Ladies and gentlemen, this concludes the conference for today. You may all disconnect and have a wonderful day.
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