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Auxilium Pharmaceuticals (NASDAQ:AUXL)

Q4 2012 Earnings Call

February 26, 2013 10:00 am ET

Executives

Adrian Adams - Chief Executive Officer, President and Director

William Q. Sargent - Vice President of Investor Relations and Corporate Communications

James E. Fickenscher - Chief Financial Officer and Principal Accounting Officer

Analysts

Eric Schmidt - Cowen and Company, LLC, Research Division

Charmaine Chan - RBC Capital Markets, LLC, Research Division

Andrew Goldsmith

Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division

Ami Fadia - UBS Investment Bank, Research Division

Gregory D. Fraser - BofA Merrill Lynch, Research Division

Thomas Wei - Jefferies & Company, Inc., Research Division

David Friedman - Morgan Stanley, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2012 Auxilium Pharmaceuticals Earnings Conference Call. My name is Lucena, and I'll be your operator for today. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to Mr. Adrian Adams, CEO and President of Auxilium Pharmaceuticals. Please proceed, sir.

Adrian Adams

Thank you. Good morning, everyone, and thank you for joining us for Auxilium's fourth quarter and full year 2012 financial results webcast.

With me this morning are Chief Financial Officer, Jim Fickenscher; Chief Medical Officer, James Tursi; and Vice President of Investor Relations and Corporate Communications, Will Sargent. Before I proceed, I would like to ask Will to read our forward-looking statements. Will?

William Q. Sargent

Thank you, Adrian. Before we get started, I would like to remind everyone that we have a slide presentation to accompany our conference call this morning, which can be viewed at our website at auxilium.com.

If you are listening to this call on your telephone, you may access the synchronized slide deck on our website by choosing the link on our webcast page that says, "Click here to listen."

The conference call and presentation this morning contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which convey management's expectations, beliefs, plans and objectives regarding future performance.

These forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product commercialization, product development, revenue, expense, earnings and cash utilization expectations, intellectual property rights, adverse litigation developments, competitive products results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing and funding, and the timing and content decisions made by regulatory authorities, including the U.S. Food and Drug Administration.

Actual results could differ materially from those described in this conference call and presentation. Information on various factors that could affect Auxilium's results is detailed in the reports we filed with the Securities and Exchange Commission. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements. I urge you to review the full Safe Harbor on Slide 1.

Now I'll turn the call over back Adrian to review today's agenda, which can be seen on Slide 2.

Adrian Adams

Thank you, Will. As we will review, 2012 was productive year for the company and the year that I believe can serve as a launching pad for success in 2013. And I'm confident that we are well poised to begin building our future now.

On this morning's call, I will give you a brief overview on Auxilium's accomplishments and commercial performance in 2012. I will then turn the call over to Jim, who will review the financial results. We will then discuss some key strategic objectives for 2013 that we believe will help us drive shareholder value, including sharing our financial guidance for 2013. Finally, we will open up the call for your valued questions.

Turning now to Slide #3. Looking back to the goals that we set for ourselves at this time last year, we consider 2012 to be have been a positive and successful year. Not only did we meet or exceed our original financial objectives and make steady progress in our research and development pipeline, but we established a mission and vision for our employees and a strategic plan that we believe will generate value for our shareholders over the course of time.

While there's a lot to feel good about with respect to our 2012 performance, I don't want to lose sight of the fact, however, that all of the positives did not result in an increase in our share price. I truly believe that our current valuation does not accurately reflect the promise that I see in Auxilium, and we will work very hard in 2013 to end the year with a more appropriate share price. Nevertheless, there were some very significant highlights in 2012, including the following: Testim achieved worldwide revenues of $237.5 million, an increase of 14% versus 2011. In late July, GlaxoSmithKline joined efforts with us to go co-promote Testim in the United States, providing us with a significantly expanded reach and a greater share of voice. XIAFLEX generated U.S. net revenues of $55.2 million, an increase of 31% over 2011. And we initiated our multicord clinical trial, which we hope will lead to an expansion of our label. After initially guiding to a net loss for the year, we increased our expectations for Testim and managed our expenses to generate positive earnings for the first time in the company's history.

2012 was also a big year for our Peyronie's efforts. We reported positive Phase III results from our 2 IMPRESS trials, filed our supplemental BLA for XIAFLEX for the potential treatment of the Peyronie's disease ahead of schedule, and we were informed by the FDA that they will take action on our request for approval by September 6 of this year.

For earlier-stage collagenase indications, we also reported encouraging top line Phase Ia cellulite data and completed enrollment in our Phase IIb frozen shoulder trial, for which we expect top line data in this, the first quarter of 2013.

Please now refer to Slide #4, as we begin to outline our commercial performance. In 2012, the testosterone replacement therapy, or TRT, market continued to grow at an impressive rate, with total revenues and prescriptions increasing by more than 30%. The TRT market remains one of the fastest-growing pharmaceutical product markets. The once daily gel segment, which accounts for just under 90% of the total TRT market, saw revenues grow by 32% to $1.9 billion. We believe some of the drivers behind this strong market growth have been increasing rates of diagnosis and treatment, considerable 2012 direct-to-consumer spend, new product approvals and a doubling of the number of TRT representatives in the field over the last 2 years. We believe that the considerable investments in disease awareness, promotion to physicians of the benefits of testosterone replacement treatment and positive demographic factors of an active aging male population will allow for significant growth in the TRT market, again, in 2013.

Turning now to more details on the Testim's performance, please refer to Slide #5. In the first half of 2011, 3 new gel products for TRT were approved by the FDA. Our expectation last year was that efforts associated with the launch of both new products would have a positive effect on the overall market. And while Testim was likely to lose market share, the growth in the market would still allow Testim to grow significantly. In 2012, Testim U.S. prescriptions grew by 8.4%, and we were pleased that Testim U.S. revenues of $233.4 million grew by 14% over 2011.

In the second quarter of last year, we entered into a 3-year co-promotion agreement with GSK, which was designed to provide us with an improved commercial footprint in this increasingly competitive TRT market. After enjoying a very robust first 6 months of growth in prescriptions and revenues, we unfortunately experienced a decline in prescriptions in the second half of the year. As we mentioned on our third quarter earnings call, we experienced some unexpected transition challenges with the GSK co-promotion. However, we believe that the graph on the left side of this chart gives us a reason for optimism. We are encouraged by the slowing of prescription share loss starting in the third quarter of 2012. And in January, although only 1 month's data, we did see our first month of market share growth since October of 2011.

I would now like to turn to Slide #6 and discuss the commercial performance of XIAFLEX. Now as you know, XIAFLEX was launched in the United States in March of 2010 as the first FDA-approved, minimally invasive treatment of Dupuytren's contracture when a palpable cord can be felt. We believe the product continues to perform well in real-world usage, both from an efficacy and safety standpoint and that XIAFLEX has entered into a period of steady annual growth and momentum.

2012 U.S. revenues of $55.2 million represents a 31% growth over 2011. The fourth quarter was our strongest quarter ever with XIAFLEX, generating $17.5 million in U.S. net revenues or a 30% growth over 2011.

The graph on this slide shows vials purchased by physicians in the blue bars and the number of unique sites that ordered XIAFLEX in any given quarter on the line chart. Last year, 1,691 unique sites purchased XIAFLEX, up 26% from the 1,340 sites in 2011. We're pleased that the number of vials used per site grew from 9.9 vials per site in 2011 to 10.5 vials per site in 2012.

Please now refer to Slide #7. XIAFLEX has continued to increase its market share of all procedures performed and is steadily marching towards becoming the standard of care for the treatment of Dupuytren's contracture patients with a palpable cord. We have recently completed some market research, which indicates that our overall user base is using XIAFLEX in approximately 45% of its Dupuytren's procedures performed as of last July. We believe this trend of growing XIAFLEX use will continue towards an intersection with a surgical trend line that the message of XIAFLEX's increasing use among treaters of Dupuytren's contracture for appropriate patients will resonate with those who have not tried XIAFLEX or are only in the early stages of incorporating XIAFLEX into their practice.

Now I would like to turn the call over to Jim to review the financial results for 2012. Jim?

James E. Fickenscher

Thank you, Adrian, and good morning, everyone. Let's move forward to Slide #8. I'd like to start this morning with a review of the accounting implications of our mutual decision to terminate the Pfizer collaboration, which will take effect on April 24, 2013. As part of the collaboration agreement, we have previously received upfront and milestone cash payments from Pfizer. Our agreement with BTC require that we pay a portion of these amounts to them. These amounts were recorded as a deferred revenues and deferred costs on our balance sheet at the time we paid -- at time paid, and we were required under GAAP to amortize the deferred revenues and costs into our income statement over the course of the collaboration agreement.

We originally estimated that the life of the Pfizer agreement would be 20 years. When the agreement to mutually terminate the collaboration was reached, the balance of the deferred revenues and cost that existed at that time on our balance sheet was required to be adjusted to record the impact of the revised, shorter life of the agreement.

At September 30, 2012, the balance of deferred revenues related to the agreement was $103.4 million, and the balance of the deferred costs was $9.3 million. In the fourth quarter of 2012, the company recorded $93.6 million in revenue, and $8.4 million in cost of goods sold as the amortization of these deferred revenues and cost respectively.

Had we not reached agreement with Pfizer to mutually terminate the collaboration agreement, we would have recognized $1.6 million and $0.1 million of revenue and cost, respectively. Therefore, the impact of this change in estimate of the life of the Pfizer collaboration agreement was an increase in 2012 revenues of $92 million, cost of goods sold of $8.3 million and net income of $83.7 million or $1.70 per share on a fully diluted basis.

The appendix to the slides we are using today provides you with a GAAP to non-GAAP reconciliation of the 2012 income statement, including the changes in estimates. As shown on Slide 9, in the fourth quarter 2012, Testim U.S. revenues increased by 3% to $58.4 million, while XIAFLEX U.S. revenues increased 30% to $17.5 million. It does appear that Testim wholesale inventories increased in the fourth quarter due to the holiday schedules and, perhaps also due to some speculative buying in advance of a price increase taken in early 2013. We believe that the increase in Testim channel inventories may have benefited Q4 revenues by $4 million to $5 million.

Please refer to Slide #10. Note that all of my references to this slide will compare the fourth quarter of 2012 to the fourth quarter of 2011. Gross margin on net revenues was 84% for 2012 compared to 77% for 2011. This increase in the gross margin rate is due to the impact of the $93.6 million in deferred revenues and $8.4 million of related deferred costs from the Pfizer agreement. Excluding this impact, the gross margin rate declined primarily due to costs incurred in 2012 for XIAFLEX manufacturing initiatives, partially offset by the impact of year-over-year net price increases on Testim U.S. product sales.

Research and development spending for 2012 was $13.2 million compared to $18.7 million in 2011. This decrease in expense results principally from a reduction in 2012 of activities related to the development of a larger scale XIAFLEX production process.

Selling, general and administrative costs for 2012 were $40.7 million compared to $50.1 million in 2011. This decrease was primarily due to lower level of spending in 2012 on XIAFLEX marketing and costs incurred in 2011 related to management changes, offset in part by cost incurred in 2012 related to the relocation of the company's headquarters.

Net income for the fourth quarter of 2012 was $90.5 million or $1.83 per share on a fully diluted basis, compared to a net loss of $11.9 million or $0.25 per share reported for the fourth quarter of '11. The increase in net income was primarily related to the $83.7 million recorded as a change in estimate from the Pfizer agreement.

As of December 31, 2012, Auxilium had $157.4 million in cash, cash equivalents and short-term investments. At the end of 2012, there were 49.3 million shares of common stock outstanding, plus 6.6 million outstanding options to purchase shares of our common stock.

Slide 11 indicates that full year 2012 Testim U.S. revenues increased by 14% to $233.4 million while XIAFLEX U.S. revenues increased 31% over 2011 to $55.2 million.

Moving to Slide 12. 2012 was, in a financial sense, a watershed year for Auxilium, as we booked our first full year of profitability. While I recognize that most of the $85.9 million in net income is a result of an upcoming Pfizer termination, even without the $83.7 million recorded as a change in estimate, we still would've been profitable.

Now I'd like to turn the call back over to Adrian to talk about our 2013 corporate goals.

Adrian Adams

Thank you, Jim. Beginning on Slide #13, I would like to discuss some of the plans that we have for 2013 and beyond. This graphic depicts the 6 core strategic objectives that form the building blocks of our strategic plan to drive shareholder value over the course of time. These are: Fully maximize the value of our current portfolio; successfully advance the research and development pipeline; aggressively pursue opportunities in specialty areas; deliver strong and sustainable financial performance; invest in people for competitive advantage; and drive high standards of operational excellence.

I want to expand in particular on the first 4 of these strategic objectives. Let's start with discussing how we will maximize the value of our current portfolio, specifically Testim and XIAFLEX for Dupuytren's contracture.

Turning first to Slide #14. We believe that Testim has a good revenue runway ahead, and this necessitates striving to maintain our #2 position. We expect that growth in 2013 will be achieved from a combination of an increase in average selling price and higher unit volume, which results from growth in the TRT market and increased market share. Our strategies will continue to focus on physicians, payers and patients. We believe that Testim has significant strength that differentiates it from other TRT gel products. Our promotional materials discuss these points of differentiation and make them meaningful to TRT prescribers. With GSK now fully on board and helping us increase our share of voice, our sales forces will execute on our promotional strategies to grow market share and maintain our focus on the high prescribers of TRT.

Just as important as promotion is making sure that access to Testim is widely available and physicians are aware of Testim's relevant coverage to their patients. With respect to payers, we intend to compete aggressively for access to priority contracts with managed care plans that we believe can move share and increase usage for Testim profitably. With patients, we expect to continue supporting programs that motivate hypogonadal men to seek treatment with Testim through branded consumer education. We also intend to provide patient support vehicles to extend persistency of treatment with Testim or assistance with patient as a pocket of cost.

Now let's turn to XIAFLEX, by referring to Slide #15. In 2013, we will continue to provide messaging that drives utilization amongst the specialists we call. After a successful January kickoff of a new speaker’s bureau, we will look to provide opportunities for less experienced sites to hear from our physician advocates. We believe that data publication in medical journals and presentation via medical meetings will help supplement our efforts. Our physician strategies are focused on increasing market share at sites where physicians are already using XIAFLEX and expanding the number of physicians adopting XIAFLEX as a routine therapeutic option.

Driving watchful waiting patients into XIAFLEX injector offices remains an important strategy to access the approximately 230,000 patients who got diagnosed with Dupuytren's every year but do not discuss treatment with a specialist or receive a disease-modifying treatment.

We are initiating new promotions, focused on health care providers with proven Dupuytren's diagnosis claims history. And we'll look to further develop relationships in order to increase referrals from diagnosing primary care physicians to experienced XIAFLEX injectors.

In 2012, we achieved 100% payor coverage for XIAFLEX. Maintaining a solid reimbursement platform with managed care plans is critical for growing adoption of XIAFLEX in 2013. We will continue dialogue with payors around the increasing data and analysis of the economic and risk benefit models of Dupuytren's that supports usage of XIAFLEX in a first-line capacity. Additionally, we plan to continue to strengthen our pharmacoeconomic support for XIAFLEX, including communication of the recently published data on 3-year occurrence rates with XIAFLEX.

In summary, we believe that we have the appropriate expectations and plans for XIAFLEX for in 2013 and we anticipate that this will translate into a year of progress as we continue to move towards our vision of establishing XIAFLEX as the standard of care in the treatment of Dupuytren's contracture for those patients with a palpable cord.

Turning now to Slide #16. XIAFLEX for Peyronie's disease straddles our 2 strategic objectives of maximizing the value of our current portfolio and advancing our research and development pipeline. We are actively responding to requests from the FDA in the ordinary course of business and we look forward to decision on approval in September of this year.

We are focused on 5 core areas that we deem critical in the preparations for successful commercial launch of XIAFLEX for Peyronie's disease, should we get approval from the FDA. Firstly, we must define XIAFLEX as the optimal solution to the unmet medical need for the serious medical condition that Peyronie's disease is. This will include 2 distinct activities. First, we plan to increase non-branded disease awareness, clearly articulating the physical, psychological and interpersonal bother of curvature deformity to the men and their partners suffering from Peyronie's disease. And second, present compelling clinical evidence on the benefits of treating this disease with XIAFLEX. Secondly, we must optimize coverage and mitigate access issues. Leveraging our experience from the Dupuytren's launch, we are developing a white glove service to assist physicians, their staff and patients from the moment the patient and physician decide to treat with XIAFLEX until treatment and reimbursing issues are resolved.

Additionally, our field-based reimbursement team will be available to provide a rapid response to solve access problems, providing proper coding education and follow-through on any unexpected roadblocks.

Thirdly, thorough support of the XIAFLEX injection and modeling procedure will be critical for success. We are currently designing instructional videos, injection simulators and manuals that will provide clear directions for physicians. Our team of regional medical scientists will be available to provide hands-on training when requested. Fourthly, we've also been developing a base of credible XIAFLEX supporters, including physician, thought leaders in Peyronie's business, as well as Peyronie's disease patients who will speak on the debilitating effects of living with Peyronie's disease. We plan to leverage these product champions to assist with access, product adoption and patient disease education efforts. And fifthly, we're identifying a targeted group of urologists who currently use invasive treatments with Peyronie's patients. We have performed market research, which we believe will help us target early adopters and treatment centers with high patient volume opportunities. And we will look to drive initial adoption within these centers of excellence.

Let's now turn to Slide #17 and review our plans for successful advancing our research and development pipeline, which has product candidates across 3 therapeutic areas -- orthopedics, urology and dermatology. Starting with orthopedics, next month, we expect to release top line data from our Phase IIa study for the treatment of frozen shoulder syndrome. After reviewing these results and gathering feedback from key opinion leaders, we will determine how we will proceed. But our current expectations is that we will begin Phase II placebo-controlled studies for frozen shoulder in the second half of 2013.

With respect to our urology focus, we are, of course, very excited about the prospects of potentially getting approval for the Peyronie's disease indication later this year. We are also very committed to maintaining a leadership position in the TRT market, and we expect to begin clinical studies in the second quarter to evaluate the viability of a concentrated testosterone gel for progression into Phase III clinical trial.

Finally, we expect to advance our third area of therapeutic focus, dermatology, in 2013 as well. After reviewing the encouraging results from the CCH cellulite study that we announced in December of last year, we are working diligently to get a well thought clinical development plan put in place, which will involve moving into a placebo-controlled Phase II study in the second half of this year.

Our next slide, Slide #18, discusses how we plan to aggressively pursue opportunities in specialty areas. To build a more robust and the valuable company, we believe that we must augment our portfolio of currently marketed products and pipeline product candidates through corporate development and licensing activities. Our current CD&L focus is on assets that would generate meaningful revenue in 2013 or 2014 and could be accreted to Auxilium in the short term.

If we achieve this goal, we may then look to add earlier stage pipeline assets in our areas of focus. We will prioritize opportunities that can leverage our current commercial infrastructure in urology, endocrinology and orthopedics, or which will help us leapfrog the learning curve and bring an established platform to an emerging area of interest such as a dermatology. Finally, we will remain opportunistic to other specialty areas like rheumatology, GI or orphan indication.

In pursuing our goals in corporate development and [ph] licensing, we will continue a dual path of looking for bolt-on products or acquisitions that build out our current franchises or a larger transformative transaction. The most important criteria for us are that the transaction must be fiscally responsible and have the ability to create value for shareholders.

I will now ask Jim to discuss how we plan to deliver strong and sustainable financial performance, specifically related to our 2013 financial guidance. Jim?

James E. Fickenscher

Thank you, Adrian. Let's move on to Slide #19. Before I discuss the specifics of our guidance, I want to point out that beginning in 2013, we will providing guidance on a non-GAAP basis. There are tables in the appendix in this presentation that layout the GAAP to non-GAAP reconciliation for both 2012 and 2013. Also, while we will only provide full year guidance, to the extent that there are some patterns that you should be aware of with respect to the quarterly phasing of our business, I will highlight those issues this morning.

For 2013, we expect total revenue in the range of $325 million to $355 million. Global Testim revenue should be in the range of $250 million to $265 million. It would not be unusual to see a destocking of Testim inventory in the first quarter of 2013.

Global XIAFLEX revenues will be in the range of $75 million to $90 million, with $65 million to $75 million coming from the U.S. Based on historical seasonality trend, we expect a revenue pattern of quarterly contribution to annual revenue that is similar to 2012's relationship. Please note that this time, at this time, we are not including any Peyronie's disease revenues in our 2013 revenue guidance.

X U.S., XIAFLEX revenues should be in the range between $10 million and $15 million. Please recall that the remaining Pfizer deferred revenue and deferred cost balances of $9.8 million and $0.9 million, respectively, will be amortized into the 2013 income statement. $7.4 million of deferred revenue and $0.7 million of deferred expenses will be amortized into the first quarter with the remainder in the second quarter.

Non-GAAP research and development expenses should be in the range of $45 million to $55 million. Non-GAAP selling, general and administrative expenses are expected to be in the range of $185 million to $195 million. Net interest expense on a non-GAAP basis should be between $3 million and $4 million. And non-GAAP net income should be between $18 million and $23 million. I want to stress that with this level of net income, it is possible that not all quarters will show a profit, and the fourth quarter is likely to be the quarter when the bulk of our profits for the year are generated due to the historical seasonality of XIAFLEX and Testim revenues.

As you can see, despite the fact that we are investing significant resources for the possible Peyronie's disease launch and covering almost $5 million of cash interest expense from the convertible debt, the midpoint of our guidance shows strong financial performance over the non-GAAP 2012 financials, including 12% growth in total revenues and 20% growth in non-GAAP net income.

I'll now turn the call back over to Adrian.

Adrian Adams

Thank you, Jim. Let's move to our final slide, Slide #20. Throughout 2013, we used this slide to keep track of how we are performing against the 4 strategic objectives that we have discussed this morning. Starting with our strategic objective of maximizing our current portfolio, we plan to stabilize and then grow Testim's market share to drive increased unit sales. Drive the market share of appropriate Dupuytren's procedures towards standard of care and prepare for and successfully launch XIAFLEX in Peyronie's disease, assuming we receive approval by the FDA.

We believe we will advance our research and development pipeline by releasing top line results for frozen shoulder in this, the first quarter of 2013. Hopefully obtaining approval of XIAFLEX for the treatment of Peyronie's disease in the U.S. in the third quarter of 2013 and initiate Phase II trials for XIAFLEX for the treatment of cellulite and frozen shoulder in the second half of 2013.

We plan to aggressively pursue opportunities in specialty areas by assessing appropriate corporate development and [ph] licensing activities that we feel make good strategic financial and shareholder sense. While it is my strong desire to complete the transaction, I do not believe that it is appropriate for us to speak to specific timelines for completion of any such transaction.

Finally, we plan on delivering strong and sustainable financial performance by achieving the guidance that Jim laid out just a few minutes ago. By focusing on these 4 strategic objectives, in particular, I believe that we will make progress towards our vision to be the most consistently successful and one of the most admired specialty biopharmaceutical companies in the United States, which in turn should allow us to drive enhanced shareholder value.

I would now like to open the call for your questions about the quarter. Operator, can you please give the instructions?

Question-and-Answer Session

Operator

[Operator Instructions] And your first question comes from the line of Eric Schmidt from Cowen and Co.

Eric Schmidt - Cowen and Company, LLC, Research Division

A couple of questions on Peyronie's. You disclosed in a filing I think last month that you don't expect or you believe you won't have an FDA panel to review that indication. Is that still the case? And then secondly, on Peyronie's, should we assume the price per unit dose is the same as in -- as in Dupuy's, or do you have any pricing flexibility to change that?

Adrian Adams

Two very good questions, Eric. On the first point, when we submitted the sBLA for Peyronie's last year, I think, we made 2 requests. One of which, obviously, was that we did not feel that there was a need for an advisory committee review. We're actually pleased that in both verbal and, more recently, written communication, the FDA have said that at this stage in their review they're not planning to hold an advisory committee. Now clearly, I think that doesn't mean they may not change their mind. But at this stage, they have confirmed that at this stage, they're not planning to have an Advisory Committee review. So we believe that, that is a positive. And more certainly, we're pleased that they appear at this stage to agree with what we put forward in the latter part of last year. On the aspect of Peyronie's, I think that's a very good question. It gets to the aspect of the value creation opportunity with Peyronie's. I think in our Phase III clinical studies, upwards of 90% patients received 6 or more injections. And clearly, I think, when one looks at the value proposition associated with this, and more certainly, at a price level from a vial perspective of in excess of $3,000, then we would expect that, that will create some significant value, and therefore, the kind of unit costs will be the same as that in Dupuytren's.

James E. Fickenscher

Eric, I'll add one comment to that. I think the area where we may see some differences between Dupuy's and Peyronie's is that we do have co-pay assistance cards and things like that. And so depending on how things start to work out, I think we have the ability to help patients with their co-pay. And we may see a higher utilization of that with a Peyronie's patient than a Dupuytren's patients. So that would affect the net. What our plan today is that we'll go out the door with the same wholesale acquisition cost.

Eric Schmidt - Cowen and Company, LLC, Research Division

If I could ask one more question. Just on the price hike, Jim, in January, what percent of that would you expect to realize and how soon?

James E. Fickenscher

So we took a 9.9% price increase on Testim. And obviously, we are in a very competitive managed care position with respect to the entire market for testosterone products. So our current belief is that somewhere close to 50% of that number will hold through the full year. We'll have to see how all the contracts actually shake out, but that's kind of our estimate today. With respect to XIAFLEX, we took a 2.5% price increase. And so that's really just underway at this point in time. We are thinking a little bit about what would happen with sequestration. But I think that our goal is that we would see a significant piece of that 2.5% price increase come through in this year as well.

Operator

The next question comes from the line of Michael Eye (sic) [Yee] from RBS (sic) [RBC] Capital.

Charmaine Chan - RBC Capital Markets, LLC, Research Division

This is Charmaine for Michael Yee at RBC Capital. I believe there was some confusion there. So my question is, with Peyronie's, can you update us on your strategy with EMA filing now that you have the right asset side [ph] and that's a strategic positive for you. So how should we think about that opportunity going forward? And secondly, with your comments about the testosterone gel market, still growing. Third-party data seems to show that the growth has subsided a bit in recent trends. Are we just seeing different capture rates there, with some market not growing as fast as it happened in the past?

Adrian Adams

I appreciate your questions. On your first point, I think, when we announced the mutual termination of the Pfizer agreement, we also mentioned that we were pleased with the strategic flexibility that, that gave us. And clearly, at this particular point in time, we're assessing a number of different tracks. One, obviously is whether is a financially disciplined and shareholder-friendly way of commercializing this on our own, in addition to looking at whether there are opportunities with additional partnerships, and there has since some inbound interest that might make it beneficial to continue the momentum with XIAFLEX in Europe. All of those particular activities are -- in no way is there inhibiting our desire to move forward in relation to putting together the MAA and submitting that under Auxilium's name in the European Union. So and we anticipate, but that hopefully will take place in the latter part of this year. On the second point, on the testosterone gel market, I think you're quite right. I think clearly, as we exited last year, I'm very pleased that the TRT gel market remained very robust in terms of growth. And certainly, we made reference to the 30% growth. And I think as it relates to 2013 and beyond, our anticipation or our best plan assumes continued growth in all. And the way I would answer your question is that in the event that, that growth rate in any way during the course of 2013 was reduced from the 30% region to high-double-digits in terms of 15% to 20% or 20%, it would still reflect one of the fastest-growing markets within the United States. So I think all of that said, I think the other point, as well is that we made reference to that there are a number of drivers in relation to driving the TRT gel market. And more certainly, we have not seen any letting up in relation to the amount of spend that is going into from a direct-to-consumer television advertising point of view in support of this class. So we're very happy with that. Our competition are obviously investing significantly in that area. That bolsters and supports the growth rates. And obviously, with our very focused targeted strategy, we look forward to leveraging that in relation to stabilizing and moving market share forward.

Operator

Your next question comes from the line of Salveen Richter from Canaccord Genuity.

Andrew Goldsmith

This is Andrew Goldsmith in the line for Salveen. I was wondering with the XIAFLEX guidance, I think you mentioned you weren't including anything in from Peyronie's in that. Given the PDUFA filing in early September, is that just conservatism or do you think there is a reason a launch might take a few months?

Adrian Adams

No, I don't think it's related to any of our views that on approval that we would take a long time to obviously bring it to market. We are pretty well advanced in our commercial planning. And although I highlighted a number of points on the call this morning, we feel good and we will be prepared to launch in the event that we get approval in a timely manner. As you well know, we have got a defined PDUFA date. And obviously, we have no control over whether or not there is any slippage in that particular timeframe because of the administrative procedures. We have no reason to believe that's going to the case. But based on that and obviously, overall count of assessments, we believe that it is prudent at this particular point in time to not include revenues this year. And clearly, in the event that we get approval in September and we launch expeditiously, that will be an upside.

Andrew Goldsmith

Great. Maybe I could squeeze one more in there. I notice there's a pretty steep drop off in SG&A spend in 4Q. Is that entirely related to the new offices or is there something else going on we should think about?

James E. Fickenscher

No, I think when you look back at the comparison to the spend versus last year, what you're seeing is that we had a significant investment in XIAFLEX marketing cost last year as compared to this year. So I think that's the bulk of the change that you see year-over-year.

Operator

Your next question comes from the line of from Annabel Samimy from Stifel.

Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division

I have a couple. First on Testim. The guidance obviously assumes that there's continued dynamic of market growth that's offsetting share loss in the testosterone market. But there's still some pretty obvious trends in testosterone marketplace that makes it sort of like a hard space to pin down. So how much of your guidance right now is supported by price increases versus the volume increase? How much is Glaxo contributing to that? And can you just describe from the transition phase that you saw last year that didn't quite give you the same market traction that you expected? And then this year also we're hearing of some very competitive prices by some of the competitors [indiscernible] formularies. So can you help us understand some of the assumptions that went into the pricing in coming up with 50% capture, or the 9.9% -- or the 9% increase because of some of the price pressure from the competitive contracts, they seem pretty steep. So just if you can give us some color there.

Adrian Adams

Obviously, quite a number of questions within one there, and we appreciate those questions. I think most certainly, starting off in reverse order, I think from the managed care perspective, as we mentioned on our call, I think, we will be as aggressive as we can in this area. You are quite right that it is very competitive. Obviously, in what is a very rapidly growing market where market share is really, really important, I think, maintaining a good position on managed care plans is pretty important. So we've got assumptions in that regard not just with the current plans but also any negotiation with other plans as well. We don't want necessarily to go into the specifics of that, but we will aggressively pursue good positioning not just in terms of maintaining but winning positions in those plans, providing obviously that good fiscal sense prevails and that they are profitable plans for the company. I think I'll ask Jim to comment in a moment in relation to the comment in relation to what proportion we see during the course of this year. As it relates to GSK, I think, again, a very good question. You are absolutely correct that as we moved into the third quarter of last year, we did have some unanticipated transition challenges with the overall co-promotion. Those are very much behind us. We are pleased with the work and relationship and the tactical deployment that we have in place at the moment through the co-promotion efforts. And most certainly all the vibes we're getting from our partner through the various committees reflect a continued commitment in this area. As it relates to our overall guidance, I think there are many different aspects that go into deriving the guidance I think. And clearly within that, we've assumed that we will stabilize market share decline and hopefully, move into market share growth in what is a continued rapidly growing marketplace and we believe that the GSK component of that, together with our projections in relation to the impact of the pricing increase we took are important components of that particular aspect. And with that, I'll ask Jim to comment further.

James E. Fickenscher

Yes. I don't know if I'll get specific as your questions were, Annabel. But I think just highlighting a couple of items on the pricing side. We took a 9.9% price increase. And all the competition in the market had about a similar price increase as well. So I think that, that effectively allows for, I'm sure some people took that price increase with the idea that they know that they're going to need that to give away as part of the discussions with some of the managed care plans. So I think the fact that the entire market starts up at a higher level and will then work to their number is probably something that's helpful. Our plans currently involve -- we've been running -- our gross-to-net on Testim has been in the 35% to 36% range. Our assumption for next year is that that's going to continue to creep up and probably get closer to the 40% range, which is effectively why the 9.9% price increase doesn't fully come down to the bottom line because we'll give some of that back in rebating strategies. So I think that's probably about as much detail as I'd want to get into with our pricing strategy from a competitive point of view.

Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division

Okay. If I could ask a follow-up on XIAFLEX. Last year, you commenced the number of -- I guess some of the same efforts that you have in place this year. One of the things that you started with the efforts into primary care and trying to get referrals from primary care. And so when you think about the guidance that you gave, it doesn't fit -- what part of that guidance is coming the efforts you started this year or is that all from things that you're starting or efforts that you started last year? Or is that all things that you've started this year, because I would assume that some of them would've started gaining some traction last year?

Adrian Adams

Yes. I think, clearly, I think as you may recall over the last number interactions we've made reference to, we were very pleased with the fourth quarter. We felt that, it was a very robust quarter, and we remain very pleased with the march towards standard of care, I think. But I've also made reference on a number of occasions that we believe we're now headed into a much more predictable, stable momentum with the product. You are quite right that during the course of last year, we -- not only did we make more efficient some of our both internal and external processes as it relates to reimbursement, et cetera, but we also initiated some more focused activities, one of which was to utilize the Testim sales force to detail to the primary care physicians that they've been calling on. And I think that was initiated in the middle or in the early part of the third quarter of last year. So clearly, as we move through the latter part of the year with that momentum, we feel that we're starting to see some impact of referrals from primary care physicians. And we're looking forward to obviously fine tune those initiatives. And that forms the basis for our assumptions for this year, and hence, our guidance for this year.

Operator

Your next question comes from the line of a Ami Fadia from UBS.

Ami Fadia - UBS Investment Bank, Research Division

I've got a couple of questions. Firstly on Peyronie's indication. Could you lay out for us the timeline and the steps with respect to getting the reimbursment code in place? One, you get approval from the FDA. And on the commercial side, could you remind us how you plan to reorganize your existing sales force to target physicians for Peyronie's and how many reps will target how many physicians? And if you think you'll need to add on to the existing sales force or not?

Adrian Adams

Two very good categories of questions there, again, thank you for raising. Those are a very important in relation to leveraging what we think is a very nice opportunity. I think as we've been assessing the commercialization of XIAFLEX in Peyronie's, I think what we -- at this particular point in time, we do not anticipate the need to increase our overall selling efforts, direct selling efforts from a sales force capacity perspective. Obviously, one of the significant differences between the commercialization in Peyronie's versus that in Dupuytren's is that we have some very strong relationships with the urologists and a lot of the key urologists that are in these centers of excellence, and we feel that it's an important dynamic difference that relates to the potential uptake of the product. It may well be -- so we have 150 Testim salespeople who are calling on a lot of the urologists at this particular point in time with long-standing relationships. So I think it may well be that overall, we'll be assessing as we fine-tune our commercial plans, whether or not the kind of deeper kind of broader capability sets needed to leverage this within the urologist community is needed. But at this particular point in time, we do not see the need to enhance or increase the level of our sales force efforts. And we will be fine tuning the specific plans of that as we progress during the second quarter, and we look forward to sharing those in a little bit more detail perhaps on our next call, the call after. But I think our plans are pretty well laid out. And clearly, part of making sure that we have a successful launch in Peyronie's is directly related to the amount of planning we do beforehand, and not just on those commercialization efforts as it relates to sales force, but also on reimbursement. And most certainly, I think, we've been doing a lot of work on the reimbursement end with advisory boards, et cetera. I'll ask Jim to comment on those now and your first question.

James E. Fickenscher

Sure. So I think, Ami, this is one of the places where we see a nice benefit for the Peyronie's launch as compared to what happened with Dupuytren's. The reason is that with Dupuytren's, we obviously had to apply for a J-code. It took almost a full year to get that J-code. With respect to Dupuytren's, -- excuse me for Peyronie's disease, it's the same exact vial, the same set up. And so the physicians will use the same J-code for reimbursement of the product that already exists. So that will be available on Day 1 of launch rather than having to use a miscellaneous J-code like we had with Dupuytren's launch. So the second thing then that we started to look at is with respect to the reimbursement of the physician procedures, which is taking care of under the CPT codes. So, if we were to move forward with a CPT code specifically for XIAFLEX injection and manipulation, there are rules around how that has to happen. The product has to be on the market for a certain period of time and you're generally looking at your second year, that you'll -- after launch where you'll -- you might be able to get a CPT code in place. Having said that, there are actually already CPT codes that exist for the injection of drug into a Peyronie's plaque. And this is the CPT code that physicians today are using when they inject things like Verapamil into Peyronie's plaques. And what our market research says so far in some of the discussions we've had with physicians is that they're actually pretty satisfied with the amount of that, that reimbursement. It's somewhere around $70 to $75 for Medicare patient on an average basis in the U.S. And so we think that by using that CPT code with a modifier to allow for multiple injections in a week and the manipulation, that the physician should be able to get pretty good reimbursement for their procedure time as well. So I think the big difference is that right out of the gate, there are CPT codes and J-codes for the physicians to use for both product and their time.

Ami Fadia - UBS Investment Bank, Research Division

Also maybe 2 other follow-ups. One, do you think you would need to do some kind of DTC advertising to just build awareness around the existence of this type of an option for Peyronie's patients. And then just separately, on Testim, could you elaborate a little bit on the next-generation Testim drug? Give us a sense on sort of the timeline around how and when you plan to develop that?

Adrian Adams

Yes. I think on your first question on DTC, I think at this particular point in time, in the initial phases of launch, we're certainly not planning any direct kind of television type advertising with XIAFLEX in Peyronie's, I think. We believe, I mean, based on a lot of the market research that we've done, our interactions with a lot of the -- not just the key opinion leaders and trialists that have been involved in the studies, that a very focused, disciplined approach to roll out is very appropriate for this. As we made reference to, there are -- we believe, there are round about 400 urologists who really account for an awful lot of the current injections and procedures, and we believe that a lot of those are centered in centers of excellence. So we think that as we progressively evolve the kind of commercial rollout that a very focused, disciplined targeted approach to those areas where -- to those urologists who are very experienced in this category, makes all the sense in the world. And clearly, if we can get some good momentum with that as we anticipate, I think we'll then make good financial decisions in relation to ongoing appropriate investments on an ongoing basis. But we believe that, that focused discipline initially to those centers of excellence and those top urologists is a very important part of our overall plan. And clearly, as we see the momentum, we'll start to make decisions in relation to investment on a going-forward basis. But I think we've got some pretty good, well laid out plans in Peyronie's. And I think there are some important similarities but also important dissimilarities with Dupuytren's, and we think overall, I think we're very much looking forward to commercializing the asset. I think from a Testim perspective, your question in relation to the next generation, I think, obviously, for competitive reasons, we don't want to say an awful lot about the development we have in place as we mentioned. I think we anticipate completion of some further work in the second quarter, which will help to shape our plans in relation to moving forward into Phase III initiation. So given all of the kind of ongoing very competitive environment and obviously, the ongoing litigations we have from an intellectual property perspective, we will be keeping our commentary in relation to specifics around the plans to -- at a very top line level. And I hope that you understand that.

Operator

Your next question comes from the line of Greg Fraser from Bank of America.

Gregory D. Fraser - BofA Merrill Lynch, Research Division

A quick question on TRT market growth and sorry to ask another question about this. But you mentioned that you expect significant growth in 2013 and you suggested that there are various ways to get to the sales guidance if growth were to slow to the 15% to 20% range, which we appreciate. But is the base-case assumption that the market grows north of 15% to 20% for the year?

James E. Fickenscher

So we typically don't get into that level of specifics, Greg, but I think what I can say is with the market growing at 32% last year, we didn't assume that it would grow anywhere near that type of a level. So I think we do believe that it's still going to be an aggressive growing market. So it's certainly that 15% to 20% would be a pretty aggressive growth for the year. But we typically don't lay out specific assumptions like that.

Gregory D. Fraser - BofA Merrill Lynch, Research Division

Okay. Are there any expenses built into 2013 guidance for the Peyronie's launch?

James E. Fickenscher

Yes.

Adrian Adams

Yes. Clearly, I think with some of the activities that we currently have ongoing in the preparation aspects and most certainly with -- we want to be in a position where we're well prepared in the event that we do get approval in the third quarter as per the PDUFA timeframe. I think and therefore, we will be ready to launch, and therefore, out of that being ready is obviously appropriate spend in the buildup towards that launch. So in essence, yes, there are spend items in relation to Peyronie's in the plan. And the way in which we've looked broadly at budget development, I think, as you obviously look to fully maximize the XIAFLEX asset whether it be in a Dupuytren's or Peyronie's, you kind of look at the overall spend levels on the asset and a portion accordingly, and we've certainly done that.

Gregory D. Fraser - BofA Merrill Lynch, Research Division

Okay. So assuming an on-time approval in the launch this year, should we think about incremental costs above the budget for the launch? Or would it be -- it would be already considered in the current plan?

Adrian Adams

Well, I think a lot has been considered within the current plan. There may well be some small increments as we progress towards the end of the year as we get greater clarity around how things are going with the FDA. But significant policies have been built in. But Jim, do you want to comment anything?

James E. Fickenscher

Yes, I think there's obviously some -- what I call variable costs associated with an actual product launch. You would do things like have a kickoff meeting. You would have your sales reps out there actually spending dollars to get access, things like that. So there's probably -- I would envision if we have an approval in the September time frame or whenever that comes, that we would revise our guidance and talk about not only changes potentially in revenue, but we would also look at what the incremental cost would be from an expense point of view. But as Adrian said, they're not huge. It's not like we're going to see a massive increase to our expense over what we've already given in the guidance.

Operator

Your next question comes from the line of Thomas Wei from Jefferies.

Thomas Wei - Jefferies & Company, Inc., Research Division

Just a couple of clarifications. One is, on the hope that your inventory front for Testim. Can you just help us understand what the absolute inventory levels were so that we could gauge how much might be taken out? Because I think I remembered it wasn't at the normal midpoint of the range to begin with, exiting 3Q. Am I correct about that? And then I had a question on just this -- the Testim commentary. I got a little bit confused. Are you assuming that you have growth in excess of the market growth i.e., you're going to gain share over the course of the year? Or does your guidance actually imply some market share losses?

Adrian Adams

I think on the latter point, I think, again, we don't really get into details specific in our forecasting models, et cetera. But most certainly, I think during the course of this year, we've assumed that in spite of our plan that we would stabilize and then obviously look to grow market share. And that combination of stabilization and growth in market share in a rapidly growing marketplace, we believe, will lead to achievement within the guidance range that we've set. On the first point?

James E. Fickenscher

And I would also just say in there, including, of course, the change in price as well is an important place [ph] to be able to say too [ph] . So on the Testim inventory levels, Thomas, typically, our inventories will bump up and down and sometimes are generally less than 30 days inventory on hand. They were at -- we had a bit a build in the second quarter. Some of that came out in the third, but they were still close to the 30 days at the end of the third quarter. We did see them get higher than the 30 days in the fourth quarter, which is what leads us to believe that there was some speculative buying. This was the third year in a row I think that we had a price at the very beginning of January. So I think that, that combined with just literally the way that the days fall out at the end of the year, the ordering pattern caused the inventories to be higher than we probably would've liked them to have normally been. But I think if you think about $4 million to $5 million as the amount that was booked in 2012, which may come out of the channel in '13, that that's probably a reasonable number. Obviously, you never can predict exactly where those wholesale inventories are going to end up at the end of any given quarter. So we'll address that on the next quarter call if it was either significantly higher destocking or not as much as what we expect.

Thomas Wei - Jefferies & Company, Inc., Research Division

So the normalized inventory rate is around 30 days? That seems a little bit high.

James E. Fickenscher

No, I said it bumps up and down. Typically it's in the range between 25 and 30 days. It was above 30 days at the end of the fourth quarter last year, that's what we were saying.

Thomas Wei - Jefferies & Company, Inc., Research Division

And then just a last question on the Day 74 letter that I assume you got from the FDA on the Peyronie's indication. Based on kind of the commentary that you've made today, it sounds like some of the issues that The Street might have raised when the data first came out like the modified intent-to-treat analysis or the clinical meaningfulness of the disease-bothered data were not really major issues raised by the agency at that point in time. Is that fair?

Adrian Adams

Well, I think correct. Obviously, in receipt of the Day 74 letter, I think, clearly, I think they were just in the initial phase of the review, I think. And a lot of the questions were relatively predictable. I think as it relates to the obviously normal course of business in relation to their ongoing review, we'll see whether or not they have any further questions. But certainly, we've not seen anything at this particular point in time. What we're the critically concerned about, well, obviously is in the initial stage. Jim, do you want to add anything to that?

James E. Fickenscher

Yes, I mean, I'd just point out some of the points that you made. Certainly as we've discussed previously, they were prespecified endpoints we had agreed with FDA in advance. So the fact that they were not addressed in that early letter would not be a surprise to us. Of course, as Adrian points out, we'll keep an eye on that. As we get correspondence from them, we'll address it appropriately.

Operator

You're next question comes from the line of David Friedman from Morgan Stanley.

David Friedman - Morgan Stanley, Research Division

Just one last one on Testim. Since the beginning of the year the testosterone market, at least, on an IMS basis is actually down sequentially, 4%, and Testim is down 8%. So I guess I'm just wondering, is there something that's happened since the beginning of the year that you believe is temporary that has been causing this trend in Testim as well as the overall market? Or -- and if you believe it is temporary, what and when would you expect this trend to sort of turn around with?

Adrian Adams

Yes. Well, most certainly, I think we think it's temporary. I think there are a lot of aspects that go into trends in the early part of the year. And clearly, we tend to focus our efforts in relation to monthly data. I think, and it's that data that we were pleased with. Although it be 1 month on the January data, it was the first time since October 2011 that we saw our market share increase. That said, I think during the course of the early part of this year, I think we've seen some continued very heavy levels of direct-to-consumer advertising. And we think that, in addition to ongoing efforts, we will continue to drive the market in a very positive direction. Jim, do you want to add anything?

James E. Fickenscher

Yes, David, I think the only other thing you probably looked, I assume when you say consecutive declines, you're looking at fourth quarter -- first quarter versus fourth quarter. But I think it is important that there is some seasonality within the TRT marketplace. When you look back the month of January, in particular, is typically a fairly weak quarter, a fairly weak month. And typically in the back half of the first quarter is where things kind of get moving again. So if you look at year-over-year growth, I don't know as I did the math yesterday when the latest week came out, but we were at about 18% TRX growth 2013 for the first 5 or 6 weeks until over 2012. So, yes, it's slower than 32% growth that we saw from the whole of last year. But as we said, our assumptions are not than we would have 30-plus percent growth necessarily in 2013.

Adrian Adams

Well, operator, I think that's the finish of the question. I'd like to thank everybody for joining us this morning. And we will certainly look forward to updating you on our progress against the checklist that I went through on our call. And will certainly look forward to speaking with you on our next quarterly call. Thank you, so much and have a good rest of the day.

Operator

Thank you very much. That concludes today's conference. Thank you for your participation. You may now disconnect. Have a great day.

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