Linda Lennox – Senior Director-Investor Relations and Corporate Communications Jeff Bailey – President and Chief Executive Officer John Bakewell – Chief Financial Officer.
Welcome everyone to the Lantheus Medical Imaging Fourth Quarter and Full Year 2014 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. This call is being recorded for replay purposes. A replay of this call will be available approximately three hours after the conclusion of the live call through to April 1.
I would now turn the call over to your host for today, Ms. Linda Lennox. Please go ahead..
Thank you and good afternoon, everyone. Welcome to Lantheus Medical Imaging’s fourth quarter and full year 2014 earnings conference call. We appreciate you joining us. I am Linda Lennox, Senior Director of Investor Relations and Corporate Communications for Lantheus.
With me on the call today are Jeff Bailey, our President and Chief Executive Officer and John Bakewell, our Chief Financial Officer. Please note that earlier this afternoon we issued a press release reporting our 2014 fourth quarter and full year results. We also filed with the SEC our Form 10-K for the year ended December 31, 2014.
You can find both of these documents in the Investor Relations section of our website at lntheus.com. The agenda for this call will include opening remarks from Jeff, a detailed review of our 2014 fourth quarter financial results from John and then a business and strategic update from Jeff along with some additional closing remarks.
Please note that consistent with last quarter’s call, we are refraining from our traditional practice of conducting a question-and-answer session due to the fact that our parent company, Lantheus Holdings, Inc. remains in registration for an offering of its equity securities.
Today’s prepared remarks have been expanded in order to anticipate the topics that may otherwise have been on your list of questions.
Before we begin, I would like to remind you that our remarks during this call may include some forward-looking statements including statements related to our products and supply arrangements and expectations for future periods. Matters addressed in these statements are subject to risks and uncertainties.
Words such as believes, expects, anticipates, hopes, plans, may and similar expressions are intended to identify such statements. Actual results may differ materially from our expectations.
Please refer to the cautionary statements and risk factors contained in our SEC filings, including our annual report on Form 10-K filed with the SEC today March 4, 2015. A copy may be obtained at sec.gov and on our website at lantheus.com.
Except to the extent required by law, we do not undertake any obligation to update any forward-looking statements and we caution you against relying on any forward-looking statements. On today’s call, we will also discuss certain non-GAAP financial measures with respect to our performance.
We use these non-GAAP indicators for financial and operational decision-making and as a means to evaluate our performance.
The definitions of EBITDA, adjusted EBITDA and net income as adjusted along with their reconciliation to GAAP net income are set forth in our earnings release, which was filed with the SEC as of March 4, 2015 as a current report on Form 8-K. Copies may be obtained at sec.gov and on our website at lantheus.com.
Please note that unless we indicate otherwise, all of our commentary on today’s call will make reference to as adjusted results. With that introduction, it is now my pleasure to turn the call over to our CEO, Jeff Bailey.
Jeff?.
Thank you, Linda. Good afternoon, everyone and thank you for joining us on our fourth quarter and full year 2014 earnings call. I will start today’s discussion with some opening commentary before handing the call over to John for his financial review. I’m pleased to report that we had a very good quarter and a strong year overall.
We continue to advance our business on a number of different fronts during 2014, especially operationally and financially. The improvement in our financial performance was evident across our entire P&L. Beginning with our revenues which grew during the full year 2014 outpacing 2013 by 6% on an as-reported basis and 8% in constant currency.
DEFINITY, our flagship product was the largest contributor to our strong revenue growth, posting a 23% increase year-over-year.
Toward sustained focus on quality, efficiency and customer service we continue to drive operational efficiencies in 2014 with along with favorable sales mix contributions increased our full year gross margin nearly 900 basis points on an adjusted basis to 41.6%, within an additional 750 basis points improving from the operating expense leverage.
Our net income as adjusted was positive on the full year basis at $41,000 for 2014. This compares to a net loss as adjusted for 2013 totaling $48.7 million. Some of our progress is reflected in our adjusted EBITDA results, which increased by 84%, year-over-year to $70.8 million for the full year 2014.
We are very pleased with the continued success of our transformation efforts throughout the year and the financial results we produced for 2014. At this time I’ll hand the call over to John for a detailed review of our fourth quarter financial results.
After which I’ll be back to take you through a more extensive business update and review of our strategic priorities. With that, John, it’s all yours..
Thanks, Jeff, and good afternoon, everyone. As Jeff, noted we are quite pleased with our latest results and I’m happy to be taking you through the details. I will be taking you through the specifics of our Q4 performance and then wrap up with a high level summary of our full year performance before Jeff provides his business update.
Before I begin, let me first note that today’s press release provides you with our P&L results in accordance to GAAP requirements and also includes tables which provide reconciliations of certain of our P&L components from an as reported GAAP basis to one that is adjusted to exclude the impact of certain special charges and credits.
Those adjustments include the current year costs associated with the initiatives we announced in November to consolidate our corporate campus. And prior year impacts related to intangible write-downs a land sale and a special recovery from manufacturer.
We will also provide a similar table with a reconciliation of our reported GAAP P&L results to EBITDA and also to adjusted EBITDA. We recognize that most of you evaluate our performance on one more of these bases but exclude certain non cash expenses as well as other special items.
And we provided you with all the information necessary for you to model our results accordingly. The full year results, that Jeff just shared, refer to these as adjusted presentations and unless noted otherwise [indiscernible] with the commentary I’ll be providing on Q4. So, with that, let’s move into our discussion of Q4 results.
Fourth quarter 2014 revenue totaled $77 million increasing year-over-year a 7% as reported and 9% on a constant-currency basis. That I’ll cover in more detail when we review of revenue performance consistent with what we’ve been experiencing all year.
The product lines that drove our fourth quarter revenue growth are also among our highest gross margin contributors as resulting favorable sales mix, accompanied by improvement in cost of sales again delivered significant year-over-year improvement in gross margin.
Fourth quarter profitability was further improved by our operating expense leverage, the result of last year’s realignment of our R&D function and broadly based efficiency initiatives.
Altogether, we posted the positive GAAP net income for the second consecutive quarter totaling $300, 000 for the fourth quarter as compared to $12.3 million GAAP net loss in the year ago quarter.
On an adjusted basis, fourth quarter net income totaled $1.5 million, an improvement of $7.6 million compared to a net loss as adjusted at $1.6 million, excuse me, $6.1 million for the year ago quarter. Our fourth quarter adjusted EBITDA totaled $19.4 million, increasing by 28% from $15.2 million in the same quarter of the prior year.
But note, fourth quarter adjusted EBITDA expanded sequentially at $300,000 compared to the third quarter of 2014. As you may recall, that in last quarter’s call, we were cautious about our Q4 outlook communicating expectations for a Q4 adjusted EBITDA performance, but might not exceed Q3 levels.
Our over achievement was driven by a combination of better than expected DEFINITY growth and its favorable mix shift on gross margin and lower than expected operating expense levels, specifically in sales and marketing and G&A.
As we look at our revenue results in detail, on a product line basis, DEFINITY continued its strong performance in the fourth quarter posting growth of 16% both as reported and in constant currency.
Our DEFINITY revenues, which totaled $25.6 million for the fourth quarter, once again grew sequentially, increasing by $1.4 million or 6% over the third quarter of 2014. Both year-over-year and sequential sales were driven by the continued adoption of contrast in echo procedures, as evidenced in the U.S.
market penetration rate for the use of contrast, which has been increasing for the past several years and has more than doubled from 2010 levels. DEFINITY now represents 33% of our worldwide revenue, growing from 31% in the fourth quarter of 2013.
Our TechneLite business posted worldwide revenue of $23.4 million for the fourth quarter of 2014, growing year-over-year by $1.3 million or 6% as reported and 7% in constant currency, reflecting growing demand from our radiopharmacy customers in particular for generators molybdenum Tc99m or moly derived from low-enriched uranium or LEU sources.
Xenon revenues, which represented 12% of our total sales during the fourth quarter, 2014 totaled $9 million, as compared to our third quarter revenue of $8.9 million. Xenon revenue grew 13% versus the year-ago quarter, both as reported and in constant currency reflecting increased usage by our customers, as well as pricing improvements.
Cardiolite revenue, which includes branded Cardiolite, as well as our generic sestamibi, totaled $4.7 million in the fourth quarter, compared with $5.4 million in the fourth quarter of 2013 and $4.7 million in the third quarter of 2014.
This product, as most of you know, has been off patent since 2008 and has been managed downward to current sales levels where it now competes side-by-side with a number of generic equivalents.
Our other product category, which represents 19% of our total revenue, and includes a number of our smaller product lines and revenue-generating activities increased by 2% on an as reported basis and 5% in constant currency during the fourth quarter of 2014 and remain relatively flat on a sequential basis.
Moving below to revenue line, our fourth quarter 2014 gross margin totaled 42.6%, a full seven percentage point improvement over gross margin as adjusted of the 35.3% posted for our fourth quarter 2013, which excludes the cardio line impairment charge of $15.4 million in the fourth quarter of 2013.
As noted previously, year-over-year revenue growth has been driven by our highest margin contributors, specifically, DEFINITY and Xenon and the resulting sales mix shift made a significant contribution toward our year-over-year gross margin expansion.
Additionally, as we have discussed in past calls, we have also been working to manage material costs in manufacturing expenses and the progress we’ve made in those areas contributed to our year-over-year margin expansion. One final note on gross margin, on a sequential basis, we are very pleased with the progress we’ve made.
Our gross margin progressively improved throughout 2014 and this most recent quarter was no exception. With fourth quarter gross margin performance improving sequentially by 80 basis points over our third quarter results driven primarily by the same favorable sales mix shift that’s driving our year-over-year improvements.
Moving now to operating expenses. We delivered considerable improvement over the past year. Our combined operating expense ratio as adjusted totaled 25.7% for the fourth quarter of 2014, a 290 basis point improvement compared with 28.6% in the fourth quarter of 2013.
This operating leverage was driven primarily by the strategic realignment of the R&D function in early 2013 and the corresponding reduced year-over-year expense run rate, offset partially by increases in G&A expense primarily related to performance based employee compensation.
Altogether, on an adjusted basis our business delivered operating income of $13 million and an operating margin of 16.9% for our fourth quarter of 2014, which is dramatically improved in comparison to our fourth quarter of 2013 operating income of $4.8 million and operating of margin 6.8%, and sequentially improved by $1.5 billion over the third quarter of 2014.
As noted earlier, a similar transformation is evident and net earnings and adjusted EBITDA with achievement of positive GAAP net income for the second consecutive quarter, adjusted net income totaling $1.5 million for the quarter and with our adjusted EBITDA expanding $300,000 sequentially with a margin reaching 25.2% for the fourth quarter.
Before we leave our P&L discussion and move into review of our balance sheet and cash flow performance, I would like to provide update on the campus consolidation initiative I discussed last quarter.
As a reminder, we recently completed an evaluation of our current and future needs and identified an opportunity to further rationalize our facilities cost by decommissioning certain of our buildings and further consolidating our campus.
As I noted last quarter, we’re excited to be executing this cost reduction initiative and expect that any future cash costs associated with our decommissioning efforts will be recovered by go forward expense savings in just over one full year.
Our consolidation effort kicked off during the fourth quarter of 2014; therefore we also began to accelerate depreciation of the net book value of these buildings over a now short and useful life leading through Q2 of 2015.
In total, we will incur approximately $8.4 million of accelerated depreciation expense of which $1.2 million is reflected in our fourth quarter 2014 GAAP results. This amount appears in our GAAP to non-GAAP reconciliations, as well any future cash or non-cash charge related to this initiative.
Before I wrap up, let me cover our key cash flow balance sheet and liquidity considerations, beginning with cash flow. We generated positive operating cash flow of $11.6 million during 2014. Q4 cash flow from operations total a negative $3.9 million, compared sequentially to a positive $19.7 million for Q3 of 2014.
Of note, fourth quarter operating cash flow includes the $19.5 million semiannual payment of our bond interest. On a comparative basis, fourth quarter operating cash flow remain consistent with Q4 of 2013, however, Q4 2013 operating cash flow included our $8.9 million recovery from a manufacture.
Normalized to exclude that special item, Q4 2014 operating cash flow improved by nearly $9 million from the year ago quarter.
Within our components of working capital, accounts receivable at December 31, 2014 totaled $41.5 million compared to $41.2 million at September 30, 2014, representing approximately a $300,000 use we had days sales outstanding of 47, representing a three-day improvement from September 30, 2014, attributable entirely to the sequencing of sales during the quarter.
Inventory on hand totaled $15.6 million as of December 31, 2014 which represents approximately 35 days of inventory on hand in aggregate. Overall, our net working capital in the fourth-quarter, excluding our debt service payment of $19.5 million contributed positive cash flow of approximately $7.7 million.
Capital expenditures during the fourth quarter of 2014 were $2.8 million compared with $1.3 million in the fourth quarter of 2013 and $1.8 in the third quarter of 2014. Capital expenditures for the full year 2014 totaled $8.1 million.
It is important to note the capital expenditures do not include the costs associated with the historic or ongoing technology transfer activities with various contract manufacturing organizations, which are expensed as incurred.
In the fourth quarter of 2014, we invested $800,000 to support these important activities compared to $800,000 in the fourth quarter of 2013 and $1.2 million in the third quarter of 2014. These costs are included in cost of sales. Cash and cash equivalents at December 31, 2014 totaled $17.8 million, compared with $16.7 million at December 31, 2014.
During the second quarter of 2014, we amended our asset-backed loan facility to increase the borrowing limit of our revolving line of credit up to $50 million.
As of December 2014 with an outstanding $8.8 million unfunded standby letter of credit and an $8 million loan balance, our resulting net availability as of that date was approximately $33.2 million and our total liquidity, including cash on hand, was $51 million, which provides ample liquidity to support our operating needs, including upcoming debt service requirements.
Before I conclude, let me add to the commentary that Jeff provided earlier with the recap of our full year 2014. all together, that was a strong year for our business. World-wide revenue for 2014 totaled $301.6 million represented a 6% increase on as reported and 8% increase on a constant currency basis over $283.7 million reported for 2013.
On a GAAP basis, the Company reported a net loss of $1.2 million for 2014, an improvement of $60.5 million over the net loss of $61.7 million recorded in 2013. Or an adjusted basis, we achieved positive net income of $41,000 for the full year, as compared to an adjusted net loss $39.8 million in 2013.
We achieved adjusted EBITDA of $70.8 million for the year. We also delivered operating cash flow of $11.6 and free cash flow of $3.4 million, funding the working capital requirements of the year’s growth. At the same time, we increased our cash balance by $1.1 million and expanded our total liquidity at $8.6 million some year-end 2013.
So to summarize, we’re very pleased with the year’s financial performance and are certainly looking forward for 2015. With that, I’ll conclude our fourth quarter 2014 financial review and I’ll now turn the call back over to Jeff..
Thank you, John. [indiscernible] review let me start with DEFINITY and a year had. As I noted earlier, year-over-year sales at DEFINITY grew more than 22% and sequential quarterly sales grew by 6%. DEFINITY is our largest product, accounting for 33% of our total revenue.
In addition to be in our fastest growing commercial product is also our highest margin product. And with sales continuing to grow each quarter, we expect contribution to our gross profit to increase. A critical strategy for the continued growth of DEFINITY is expanding, the appropriate use of contrast.
Our nationwide sales force, which is solely dedicated to DEFINITY works diligently every day to show clinicians the benefits of the appropriate use of contrast, which include improvement and in image quality and reduced number of suboptimal echo studies and potentially better patient management a lower downstream healthcare cost.
The true contrast [ph] penetration rate, which is the percentage of all U.S. echocardiography studies performed with an imaging agent of any time, has performed significantly over the last couple of years. We exited 2014 for the three-month average, U.S.
contrast penetration rate of 4.1%, and all time high since the launch of DEFINITY in 2001 and by growing by 24% or 80 basis points from the markets 2013 exit rate of 3.2%. Even with this significant year-over-year growth and a contrast penetration rate, the U.S.
ultrasound contrast market is still significantly under penetrated continually 4.1% at echo is currently get contrast, even though 20% or more are considered suboptimal.
With our continued efforts in 2015, to raise awareness about the benefits of ultrasound contrast and we expected additional voice in the marketplace we believe the contrast penetration rate will continue to grow for the foreseeable future.
As I mentioned on our third quarter call the FDA approved a third echocardiography contrast imaging agent in October 2014. The agent approved has actually been marketed for more than 10 years outside the U.S. under the trade name SonoVue. We have been expecting for [indiscernible] really preparing for the new agent’s entrance into the U.S. market.
We remained focused on increasing the appropriate use of contrast overall in protecting DEFINITY’s position in the growing dynamic marketplace. However, another competitor may put near-term pressure on volumes and pricing, we believe additional voice of U.S.
contrast imaging marketplace should raise further awareness of the benefits and the appropriate use of ultrasound contrast, ultimately benefiting all participants in this under penetrated market including DEFINITY, the market’s leading brand. Now I’ll update you on the status of our discussions with Cardinal.
In late 2012, Lantheus signed supply agreements with Cardinal, but subsequently expired on December 31, 2014. Following the extended discussions with Cardinal during 2014, we entered 2015 without a contractor supply agreement with Cardinal.
We continue to offer to Cardinal the same products we previously provided now there are other supplier price points offered to our non-contracted customers. Cardinal has historically been one of our largest customers, purchasing a number of our products for use across the radiopharmacy network.
In 2014, Cardinal accounted for approximately 18% of our total revenue. Our current, no contracts status with Cardinal will likely result a change in our customer mix for our non-DEFINITY business.
We expect lower volumes in 2015 that we experienced in 2014, and lower revenues, however, we believe that our operating profit will not be impact to the some extent as our revenues.
Given our position as the leading supplier of LEU generators and the sole supplier of Xenon and Neurolite we believe that Cardinal’s radiopharmacies will continue to purchase SonoVue on products fronts.
Since we can’t anticipate how much Cardinal will purchase from us, we believe the timing and the amount of our revenues will be less predictable quarter-to-quarter.
It’s important for me to say that the door remains opened but we have consistently communicated Cardinal, our desire to reach a mutually acceptable agreement for the to benefit [indiscernible] both of our companies, the nuclear medicine industry and most importantly the patients we both serve.
I’d like to spend some time now updating you on our supply chain. The key part of our transformation Lantheus news is ongoing strengthening of our supply. We continue to deliver ways to further expand and diversify our supply chain, as we have recently achieved many wins.
These include on a DEFINITY front, we have over six months of work-in-progress inventory or WIP, as well as good progress for developing Pharmalucence and future seconds for our DEFINITY supply. We continue to expect submission by year-end of the second manufacturing site for FDA review.
As I mentioned on our third quarter call, we entered into a strategic agreement last November for the future supply of LEU Moly with Wisconsin-based Shine Medical Technologies. This marks our first agreement with a perspective domestic supplier of moly. Shine expects there is new source available with, Moly to become available to us starting at 2018.
As a leader in the radio pharmaceutical business and the industry leader in adopting the use of LEU Moly, we have secured a globally diversified and balance supply of Moly for Technolite generators. We currently have contracts with four of the five major processors and seven of the eight associated reactors.
This agreement with Shine demonstrates our ongoing commitment in securing future reliable access for Moly. In January 2015, we entered in some agreement, with Institute for Radio-Elements or IRE for the future supply of Xenon. We are very committed to securing ensuring reliable access to Xenon. Presumably, we are the only U.S.
supplier to Xenon, which is a byproduct of Moly production process. We currently receive Xenon which are nearly on and the NRU reactor, which is expected to see stability in production medical radioisotope in October 2016. This agreement with IRE ensures there will be continues supply of Xenon 2016 and beyond.
Speaking of the NRU reactor, each year that reactor undergoes a routine month long scheduled shutdown from expecting and maintenance as required by the [indiscernible] regulators. This year, the NRU maintenance shut down is scheduled form April 13 to May 13.
We have worked with NCP in the South Africa, hence now in Australia and IRE in Belgium to range ultimate moly supplies during the NRU outage. As a result we currently believe that we’ll be able to source all of our standing quarter customer demand for technetium generators during this period from our global supply chain.
Lastly but importantly, the supply chain front in January, the FDA granted approval of Jubilant HollisterStier, or JHS to be a new manufacturing site for Neurolite. This is a major step in assuring that we have long-term sufficient supplier Neurolite.
In addition, we’ve recently receive regulatory approvals for JHS manufactured Neurolite in Australia, Canada and Japan. On the pipeline front, I would like to provide you with an update on the status of our Flurpiridaz F 18 program.
The first of two Phase 3 trials provided valuable evidence of the overall effectiveness and safety of Flurpiridaz F 18, even though, we’ve had missed on the two co primary end points.
In the fourth quarter of 2014, we completed a re-read of the 301 trial results, which confirm first, the overall performance of the agent when compared to coronary and geography the true standard. And second, the performance of the agent against SPECT and TI for sensitivity and specificity similar to the results an initial read.
However, statistically and clinically significant improvements for SEPECT were observed in special populations, clinical interest that includes winning [indiscernible] patients. In addition Flurpiridaz F 18 show statistically securing all of these, over SPECT in accuracy, diagnostic certainty and image quality.
Importantly, Flurpiridaz F 18 study is excludes patients to approximately 50% plus radiation with SPECT studies. Moving forward an agreement with the FDA, we are currently finalizing the study design of the second Phase 3 trial with new primary and secondary end points and we submitted a Special Protocol Assessment or SPA to FDA last month.
At the same time, we continued with potential strategic partners to further develop and commercialize Flurpiridaz. We are also seeking strategic partners to further develop our two earlier stage development candidates, our PET based Cardiac Neuronal Imaging Agent and our MRI based Vascular Remodeling Imaging Agent.
We also continue to pursue opportunities to strengthen and diversify our existing commercial portfolio and drive revenue growth. This is nothing specific, that I can share with you at this time. However, we are active in evaluating a number of potential opportunities.
And I look forward to updating you on the status of our business development activities on future calls. On the Zurich litigation front nothing has changed since I updated you on our last quarter’s call. Just to recap, Zurich filed a motion [indiscernible] on July 14, 2014.
We filed a memorandum of law in opposition to Zurich’s motion for some reduction judgment on August 25. Zurich filed a reply memorandum of law in further support of its motion for summary judgment on September 15. Expert witnessed, discovery was completed on October 31.
At this time, we continue to wait for the judges’ decision and cannot predict when that maybe or what the outcome maybe.
Finally, we continue to have our updated registration statement un-filed with the SEC, separate at par from any future capital markets activities, remained focused in a presence, and continuing to strengthen our financials and advance key business initiatives that will drive the success of the company.
Altogether, we are quite pleased with the fourth quarter and the full year 2014 financial results. We are well prepared to address and mange any headwinds that they come on way in 2015.
We have a strong culture of quality, efficiency and customer service, we’ll continue to build upon the strategic, operational and financial progress we made in 2014 and position the company for long-term growth. I look forward to updating you on our next earnings call. With that we will conclude today’s call..