Earnings Labs

Repligen Corporation (RGEN)

Q4 2014 Earnings Call· Fri, Mar 13, 2015

$112.63

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Transcript

Operator

Operator

Welcome to the Repligen Corporation's Fourth Quarter And Year 2014 Earnings Conference Call. My name is Nicole and I will be your coordinator today. [Operator Instructions]. I would now like to turn the call over to your host today, Sondra Newman, Senior Director of Investor Relations for Repligen.

Sondra Newman

Analyst

Thank you, Nicole. Good morning, everybody. The purpose of today's call is to review our 2014 financial results and business highlights and provide financial guidance for the year 2015. Joining me today are Walter Herlihy, our President and CEO; Jon Snodgres, our CFO; and Tony Hunt, our COO. The discussion today may contain forward-looking statements that are subject to risks and uncertainties and may cause our plans to change or results to vary. In particular, unforeseen events outside of our control may adversely impact future results. Additional information concerning these factors is discussed in our annual report on Form 10-K to be filed on or before March 17, the current report on form 8-K, which we filed today and other filings that we make with the Securities and Exchange Commission. The forward-looking statements in this discussion reflect management's current views and may become obsolete as a result of new information, future events or otherwise. We may not update such forward-looking statements except as required by law. Now I will turn the call over to Walter Herlihy for an overview of 2014.

Walter Herlihy

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Thank you, Sondra and good morning. 2014 was an excellent year for Repligen. As reported today, we had record sales of our bioprocessing products of $60.4 million, an increase of 27% over 2013. Our results derived from strong organic growth of approximately 13% in addition to $6.8 million in sales of the ATF product line which we acquired from Refine Technology in June. We also expanded our gross margin to 53.6%, an improvement of approximately 98 basis points despite a $400,000 or 68 basis point headwind due to ATF inventory re-evaluation and nonrecurring ATF manufacturing transition costs. Our R&D group completed designs or prototypes for three new products scheduled for launch this year and they developed yield improvements for several high-volume processes to support continued improvements of gross margins. We bolstered our management team with the hiring of Tony Hunt as our Chief Operating Officer and Jon Snodgres as our Chief Financial Officer to effectively manage our expanding business. I am pleased that Tony will be our next CEO and I'm confident that his commercial experience in the bioprocessing market will serve Repligen well. To prepare for this next phase of growth, we also significantly expanded our sales force and commercial infrastructure to enable us to more effectively sell our OPUS and ATF product lines directly to end-users worldwide and to support the launch of new products in 2015. With the opening of our new ATF manufacturing facility in January of this year and additional office space last quarter, we have completed our capital investment program to support our expansion for the next three years. And we ended the year with a strong balance sheet including $62 million in cash and no debt. In summary, we believe we have in place the product portfolio, the management expertise, the facilities and the financial resources to support sustained growth and increase profitability in the growing market for biologic drugs. Our business strategy is based in part on our belief that the market for monoclonal antibodies will continue to expand driven by the introduction of new antibodies which address significant unmet medical needs and a growing contribution from Asia. In 2014, there were a record eight new antibody products approved including two exciting new products for cancer from Merck and Bristol-Myers respectively. We also saw the filing of marketing applications for two monoclonals developed by both Amgen and Sanofi which address the significant need to reduce elevated levels of cholesterol. And there are many other exciting products in the pipeline. We believe that the monoclonal market will expand at 8% to 10% for the next five years driving the growth of both our Protein A business and the opportunity for our proprietary products. Now I will turn the call over to Jon for a review of our 2014 results and our expectations for 2015.

Jon Snodgres

Analyst · Stephens Inc. Your line is now open

Thank you, Walt. Good morning. Today we reported our financial results for the fourth quarter of 2014 which were highlighted by strong sales of our key bioprocessing products. We reported product sales of $15.4 million, an increase of approximately 49% compared to Q4 of 2013 despite a 6% headwind from foreign currency fluctuations in the quarter. We experienced increased demand for Protein A affinity ligands in our OPUS line of pre-packed chromatography columns during the order. In addition, we had record sales of ATF products with strength in both benchtop and production scale units. As a reminder in the fourth quarter of 2013, Repligen received $5 million of royalty revenue from Bristol-Myers Squibb based on their U.S. sales of Orencia under an agreement that expired on December 31, 2013. For the fourth quarter of 2014, gross profit from bioprocessing product sales was $7.3 million or 47.5% of product revenue compared with $5.7 million or 55.3% for the same period in 2013. The lower margin percent versus 2013 was the result of expected Refine integration costs and reduced capacity utilization in our Swedish factory. Research and development expenses of $1.3 million were approximately equal to the fourth quarter of 2013 as we continued to invest in three key product development programs scheduled to launch in 2015. SG&A expenses increased from $3.4 million to $5 million as a result of expected investments in our management and commercial teams and costs associated with the build-out of infrastructure and personnel to support our future growth. The acceleration of ATF sales in 2014 resulted in an achievement of the 2014 Refine contingent consideration sales milestone. This coupled with an increased probability of achieving the 2015 sales milestone required an additional $2 million of contingent consideration expense to be recorded in the fourth quarter. The fourth…

Tony Hunt

Analyst · Stephens Inc. Your line is now open

Thank you, Jon. We're clearly very pleased with the performance of our business in 2014 and we have strong momentum and customer demand as we move into 2015. To reiterate, we expect very strong organic growth in 2015 with all four product groups and all regions contributing to our growth. We expect 8% to 10% growth in our affinity ligands business and more than 40% growth for our direct product portfolio. The year is off to a strong start and we expect record sales here in Q1 well above our prior best quarter. 2015 is a year in which we expect to progress on multiple fronts from operations to R&D and commercial. In our operations group, we continue to focus on gross margin expansion through capacity utilization and yield-based strategies and we're currently implementing process improvements identified in 2014 by our R&D team for several of our large volume products. Our R&D team is also focused on developing and launching three new products this year. We're on track to launch a 60 centimeter diameter OPUS column by the end of Q1 which will have nearly twice the capacity of a 45 centimeter diameter column and will be suitable for use with large 2000 liter bioreactors. We're excited by the early interest in the product including new orders for delivery in 2015. We're the only company offering such a broad range of pre-packed columns and with this lunch we're well-positioned to establish OPUS as the clear leader in the pre-packed column market segment. Our next-generation Protein A media is also tracking towards an anticipated launch in mid-2015. We're currently in the scale up and validation phase and we see strong synergies and interest for this product with our OPUS customers working at clinical and niche commercial scale where the high performance…

Operator

Operator

[Operator Instructions]. Our first question comes from Drew Jones of Stephens Inc. Your line is now open.

Drew Jones

Analyst · Stephens Inc. Your line is now open

Tony, you touched on this a little bit but looking at capacity now that you guys have finished the Waltham facility, can you may be walk through where we're capacity wise on each of the major product lines?

Tony Hunt

Analyst · Stephens Inc. Your line is now open

Sure. Overall, capacity is around 70% across our facilities. I would say for the newer products like OPUS and especially OPUS, it is less than 50% capacity utilization and ATF would be significantly less than that as well. And our goal is obviously over the next in 2015, 2016 is to continue to drive volume to the plants.

Drew Jones

Analyst · Stephens Inc. Your line is now open

You talked about the sales force expansion. Where are you guys putting people to push the OPUS in the ATF product opportunity?

Tony Hunt

Analyst · Stephens Inc. Your line is now open

So in the U.S. we have added in sales reps in the Midwest, Northeast, West Coast so we have a pretty good coverage now across North America. In Europe, we have a number of reps as well covering central. We just brought on a Central Europe rep at the beginning of the year. And in Asia obviously, we have a person there since mid-last year. So we think actually the areas of growth are purely central in Europe and also in Asia and we think there's expanded opportunities in North America.

Drew Jones

Analyst · Stephens Inc. Your line is now open

And just an update on the filing of the 10-K?

Jon Snodgres

Analyst · Stephens Inc. Your line is now open

We expect to file on or before the 17th.

Operator

Operator

Thank you. Our next question comes from the line of Bryan Kipp of Janney Capital Markets. Your line is now open.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

The first one for me, can you tease out the bridge for 2015? I am just thinking in context, I think prior you had mentioned $1 million to $2 million of incremental revenue from new products. On the delta here from prior guidance to new guidance is that all ATF? Just any color on that would be helpful.

Jon Snodgres

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Sure. We have actually, from prior guidance, seen growth in generally of our product lines, Bryan. So it spans from affinity ligands all the way through ATF and OPUS as well as growth factor, so we're [Technical Difficulty] demand up by everywhere.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Still $1 million to $2 million from new products, or has that jumped up a little?

Walter Herlihy

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

I think that's reasonable but those numbers are folded into of course the estimates for OPUS being up 50% for example. That includes the new product contribution there. I think for us the story and the revision of the guidance, as Jon said, was just a ground swell across all product lines growing with affinity 8% to 10% and the other lines much more robustly. And typically we've seen in past periods some product lights advancing more robustly than others. What we're seeing this year is all product lines advancing together leading to a much higher organic growth projection for the year.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

And then I guess now that Refine is basically fully consolidated into Waltham, do you have any updated view on the incremental opportunity on margins whether it is in line with OPUS or growth factors or Protein A. Just trying to think in context now that you guys have fully housed that and what the opportunities are going forward?

Jon Snodgres

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

That is all encompassed within our projections of 55% to 57% margins. So that would represent expansion over 2014.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Okay, so most of the delta is going to be probably ATF net consolidation?

Jon Snodgres

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Also the fact that as we increase the projection for the affinity ligands, we get incremental better capacity utilization both in the Lund factory and the plan here in Waltham as well. It's a combination of both of those effects.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Okay. And would you guys be willing to give any color or commentary around backlog? I know you said it is strength in ATF and you continue to see uptick in demand as well as maybe some orders on the 60 centimeter side, stronger backlog going into 2015 versus 2014 and just any indications of pace [indiscernible] would be helpful.

Tony Hunt

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

We clearly had a great Q4 and we saw strength in both the benchtop units and in the production units and we had good order demand coming in here in Q1. So we have a good Q1. We have visibility really into the first half of the year; first half of the year looks pretty healthy. Clearly it's a little early to talk about second half of the year. But I think when we get to the Q1 conference call, we will be able to give you a bit more color on how the second half of the year is shaping up. But we're very pleased with the way ATF has performed in the first seven months and we're looking forward to a good 2015 as well.

Operator

Operator

Thank you. Our next question comes from the line of Brandon Couillard of Jefferies. Your line is now open.

Unidentified Analyst

Analyst · Brandon Couillard of Jefferies. Your line is now open

This is Sachin [ph] in for Brandon. Will you give us an update on how the OPUS user base is developing in terms of number of customer applications?

Tony Hunt

Analyst · Brandon Couillard of Jefferies. Your line is now open

Yes, I think when you look at the way OPUS has developed over the last year, we clearly -- we doubled the business in 2014 and we're definitely anticipating and expecting as we go through this year that we will see somewhere in the north of 50% growth may be as high as 75% growth for the year. What we have seen in terms of development is as we have expanded our commercial organization, we're getting more opportunities and we're also seeing -- which I think I have referred to in the past -- is we're seeing multisite adoption going on. The CMO organizations really like the benefits of OPUS and when you look at our base of accounts, it continues to increase. We're seeing more multisite adoption and we're seeing broader adoption at CMO.

Unidentified Analyst

Analyst · Brandon Couillard of Jefferies. Your line is now open

And would you quantify the expected contribution of the 60 centimeter column that you have in your 2015 guidance?

Tony Hunt

Analyst · Brandon Couillard of Jefferies. Your line is now open

It is rolled -- 60 centimeter is part of our guidance. It is rolled in but the way I would look at it is really the combination of 45 centimeter and 60 centimeter diameter columns. Last year 45 was a big success for us. We estimated $1.5 million to $2 million in sales. When we look at 60 centimeter, we see it as an -- it's kind of like a brother sister. The two columns are really going to help in terms of doing 1000 liter, 2000 liter bioreactor processing. So the customers will select a 60 centimeter based on the scale they want to go to but if they pick 45 centimeter because they are working at 1000 liter scale, that is fine too. So we see this as the big differentiator between us and the competitors.

Operator

Operator

[Operator Instructions]. Our next question comes from the line of Bryan Kipp of Janney Capital Markets. Your line is now open.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Tony, just in context to your comment and prior guidance of that $2 million to $2.5 million in incremental from 45 centimeter in 2014, are you guys willing to give us a little bit harder number on how that actually performed within the range?

Tony Hunt

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

For 45 centimeter, it was $1.5 million to $2 million is what I said, Bryan.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

Okay. Any more granularity, or do you want to keep it to that range?

Tony Hunt

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

No, that's about as granular as we can get. We expect 45 is going to continue to be a strong performer for us and I think when you add 45 centimeter and 60 centimeter together we have a very nice differentiator in the marketplace especially for the 1000 liter to 2000 liter bioreactors.

Bryan Kipp

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

How much of that $1.5 million to $2 million was passed through? I am just thinking in context to media. Did you guys fill some of those columns into your 10% bump up on sealing that media and is that just core product I guess is what I'm getting at, that $1.5 million to $2 million, or is there some media in there as well?

Walter Herlihy

Analyst · Bryan Kipp of Janney Capital Markets. Your line is now open

There is always media involved but what we do see as the columns get larger and the media acquisition costs get larger, we see customers actually supplying the media, consigning it to us, so with the 45 centimeter it was closer to the 50-50 ratio of columns versus media as compared to a higher ratio of media in some of the really small columns where we always buy the media. So I expect at the end of the day as we look forward with the 45 centimeter and 60 centimeter, it will be 50-50 columns of media as more and more customers take advantage of large volume discounts they get from the media suppliers themselves.

Operator

Operator

Thank you. I'm showing no further questions at this time. I would like to hand the call back over to management for any closing remarks.

Sondra Newman

Analyst

Thanks, everyone for joining our call today. Feel free to contact investor relations with any follow-up questions and we look forward to updating you on our Q1 call.