Earnings Labs

Repligen Corporation (RGEN)

Q2 2009 Earnings Call· Mon, Nov 24, 2008

$112.63

-4.12%

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Same-Day

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1 Week

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1 Month

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Repligen Corporation second quarter 2009 earnings conference call. My name is Michelle and I will be your coordinator for today. At this time, all participants are in a listen-only-mode. We will be facilitating the question-and-answer session towards the end of today’s conference. (Operator instructions) As a reminder, this conference is being recorded for replay purposes. And I would now like to turn the presentation over to your host for today’s call, Mr. Bill Kelly, Vice President of Finance and Administration. Please proceed.

Bill Kelly

President

Thank you, and good morning. The purpose of today’s call is to briefly review our financial results for Q2 FY 2009, affirm our financial projections for FY 2009, and to provide additional information on our development programs. Joining me today is Walter Herlihy, our President and CEO. At the outset, I would like to state that this discussion will contain forward-looking statements, which are not guarantees of future performance, such as our financial projections and projections for US sales of Orencia, opportunities for licensing, our intellectual property portfolio, and our plans and projections – our plans for – our projections for clinical trials. These statements are subject to certain factors, which may cause Repligen’s plans to materially differ or results to materially vary from those expected, including market acceptance of our products, unexpected preclinical or clinical result delays, delays in manufacturing by us or our partners, failure to receive adequate supply of clinical materials from our partners, timing of product orders, delays in or failure of regulatory approval, adverse changes in commercial relationships, and a variety of other risks set forth in our filings with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K. Except in circumstances in which prior disclosure becomes materially misleading in light of subsequent events, we do not intend to update any of these forward-looking statements. This morning, we released our financial results for the second quarter of FY 2009, which ended on September 30th, 2008. For the quarter, we recorded total revenue of $5.1 million, including product sales of $3 million and royalty income of $2.1 million. Our net profit for the quarter was $142,000. And our cash and investments on September 30th were $65.6 million or $5 million more in March 31st. Total revenue for the six-month…

Walter Herlihy

President and CEO

Thank you, Bill. As most of you know, we received a royalty on Bristol-Myers’ US sales of Orencia, their biologic therapy for rheumatoid arthritis. This quarter, Bristol continued the release of new clinical data supporting Orencia’s use. In October, they announced that a 10-month study showed that Orencia significantly improved multiple aspects of quality of life in patients with juvenile idiopathic arthritis, which were maintained throughout the study period. In the second press release, Bristol reported results from the study in adult patients with moderate to severe (inaudible) of rheumatoid arthritis who had never received previous methotraxate treatment. This study shows that Orencia in combination with methotrexate had a 76% greater chance for achieving remission, compared to methotrexate alone and an equivalent safety profile. The continued news flow and the dozens of new publications on Orencia in 2008 had undoubtedly helped support its rapid sales growth. In the last four quarters, US sales have increased from $57 million to $98 million per quarter, for a compound quarterly growth rate of 14.5% or an annualized rate of 71%. We anticipate that these clinical data will continue to drive the growth of this product. Turning now to our own pipeline, our Phase 3 trial of secretin in MRI imaging is currently recruiting patients to 24 sites in the United States, and there are approximately 90 patients in various stages of the trial. At the current enrollment rate, we believe we will complete enrollment in mid-2009. One of the critical assumptions empowering our trial is the percentage of enrolled patients who actually have a pancreatic structural abnormality. Based on our Phase 2 study, we assumed that 55% to 60% of enrolled patients will have a structural abnormality. A review of the first 73 patients enrolled in the Phase 3 trial indicates that 68%…

Operator

Operator

(Operator instructions) Your first question comes from the line of Ram Selvaraju of Rodman & Renshaw. Please proceed. Ram Selvaraju – Rodman & Renshaw: All right. Thanks. Can you hear?

Walter Herlihy

President and CEO

Yes. We do. Ram Selvaraju – Rodman & Renshaw: Okay. I just wanted to get some additional clarification on a few line items on the P&O. So with respect to the remainder of fiscal 2009, could you provide some additional color on what you expect R&D and SG&A expenses to look like?

Bill Kelly

President

For the full year R&D spending, we expect it to be about $14.6 million and SG&A spending about $5.8 million. Ram Selvaraju – Rodman & Renshaw: Okay. Thank you. Also could you just reiterate when you would expect this safe to your uridine study to mature and yield top line data?

Bill Kelly

President

It’s hard to say at this early stage on what the enrollment rate is going to be. We would anticipate it would take about 15 months to enroll the patient under normal circumstances. So by the end of 2009, we should have the study largely enrolled. Ram Selvaraju – Rodman & Renshaw: Okay. And then with respect to your pursuit of addition end licensing opportunities, could you provide some color on what kinds of product candidates you feel would be best suited to bring in to focus on reference pipeline? And what therapeutic indications you might be targeting as you look for potential licensing opportunities?

Walter Herlihy

President and CEO

Sure. We have looked at 30 opportunities since the end of June. I would say approximately 25 of those were in CNS area. An area we know well and an area where we think we can make an informed decision about the value of an asset. And the others were in various areas where they was an opportunistic perhaps entry point. Generally, the projects that we look at and the once that we favor are once in which there’s a compelling biological story to support the potential utility of a lead compound and the disease indication. And there’s an ability to run a Phase 2 clinical trial with 200 patients or fewer, which will give you a yes-no answer on the compound of interest. Many of these are earlier stage because that’s where we find the higher qualities on science. And in many ways are similar to the previous ataxia asset in which we licensed in 2007. And which over the last year and a half has moved up to almost the clinical stage. Ram Selvaraju – Rodman & Renshaw: Okay. And then just a quick read to read. Could you reiterate for me the projected profits for fiscal 2009?

Bill Kelly

President

We affirmed our previous guidelines of between $4 million and $5 million. Ram Selvaraju – Rodman & Renshaw: Okay. Thank you.

Operator

Operator

Your next question comes from the line of Don Chev [ph], private investor. Please proceed.

Don Chev

Analyst

Good morning, Walter.

Walter Herlihy

President and CEO

Good morning.

Don Chev

Analyst

How far along are you with regard to European or Japanese partnerships with MRCP?

Walter Herlihy

President and CEO

I’d say we’re in the early stages of engaging selected potential partners. And we’re taking a very careful approach to these to make sure that those partners we approach or loan to will think can really deliver in a commercialization of the MRI agent. And it’s too early to comment on the specific discussions we’ve had to date. But we do think that these discussions will mature over the next six to twelve months.

Don Chev

Analyst

You’ve seen good quality opportunities there?

Walter Herlihy

President and CEO

In partner potential?

Don Chev

Analyst

Yes.

Walter Herlihy

President and CEO

Yes. We’ve had some discussions with some very high quality organizations.

Don Chev

Analyst

And your estimate of the market outside of the United States? Europe, Japan, wherever?

Walter Herlihy

President and CEO

It’s probably at least as big as the US market. We think that there’s about 150,000 potential procedures in the United States could benefit from use of this agent and another 150,000 in Europe. We don’t have specific numbers in Japan, but it’s probably a fraction of that again.

Don Chev

Analyst

And the cost of that was – what was that? $200?

Walter Herlihy

President and CEO

Well I think the current pricing, the wholesale pricing for a single vial for a single procedure is about $400 per procedure.

Don Chev

Analyst

So what would our selling price be?

Walter Herlihy

President and CEO

Well we haven’t determined that. But if you were to assume it were $400 per procedure times a 150,000 procedures that would give you about $6 million addressable market in the US and an equal market in Europe.

Don Chev

Analyst

I thought – isn’t that higher than what you have said before? I meant – I certainly don’t object to that?

Walter Herlihy

President and CEO

Don, I think we have painted about $100 million or so in rough numbers.

Don Chev

Analyst

No. I meant the cost I thought was lower than the $400. But you’re talking $400, right?

Walter Herlihy

President and CEO

Our market research supports that quite clearly.

Don Chev

Analyst

And on Freidriech’s ataxia, has that met disappointed or exceeded where you had hoped it would be at this time?

Walter Herlihy

President and CEO

I think when you enter these early stage projects, there’s always considerable concern and risk that the miles will be toxic as mechanism won’t pan out. But I would say for me personally, it exceeded my expectation with how quickly it’s come to the point where we’re going to make a clinical decision about the end of this calendar year.

Don Chev

Analyst

And one more thing you have talked about potential deals or pipeline enhancers? You said that 30 since June. That’s a lot. Do you see pursuant to that Wall Street Journal article, the quality of opportunities improving?

Walter Herlihy

President and CEO

There’s a few quality opportunities. The vast majority of them I think are still too early and too uncertain and the biology’s not up to snap. But we certainly have found in that 30 a couple of opportunities worth taking a deep dive into.

Don Chev

Analyst

But do you see any improvement in the flow or the quality–?

Walter Herlihy

President and CEO

Yes. The flow is higher. The quality is about the same.

Don Chev

Analyst

Okay. Thank you.

Walter Herlihy

President and CEO

Okay.

Operator

Operator

(Operator instructions) Your next question comes from the line of Robert Lazaros, private investor. Please proceed.

Robert Lazaros

Analyst · Robert Lazaros, private investor. Please proceed

Good morning. I’m wondering if there’s any contact or discussions regarding interest in the acquisition or purchase of our company, Repligen?

Bill Kelly

President

We have nothing to disclose. And we normally wouldn’t disclose any potential discussions about acquisitions. I think that our focus is really trying to take advantage of the opportunities that present us in our pipeline. And as you look into the call today, I’m sure you’ve heard a number of milestones coming up in 2009, which would ensure our pipeline. Internally, I think the value of the company would be greatly enhanced or would be successful on some of these pipeline products.

Robert Lazaros

Analyst · Robert Lazaros, private investor. Please proceed

The reason I asked that question is there’s seems to be so much press on the voracious appetite of mid and large firm and biotech attempting to acquire assets like ours.

Bill Kelly

President

Well I think–

Robert Lazaros

Analyst · Robert Lazaros, private investor. Please proceed

So I thought it would be a natural – for discussions purposes anyway.

Bill Kelly

President

Absolutely. I think there is a voracious appetite of big pharma in particular, the Mid Ice Pharma [ph], the filler pipeline, and our whole business model is geared towards that. And that we are going to retain full commercial rights to our products through at least a proof of concept clinical study. And that’s where I think we can get a very high valuation we all like to get for our investment in some of these product candidates. As opposed to selling them too early before they fully mature and can recognize their value.

Robert Lazaros

Analyst · Robert Lazaros, private investor. Please proceed

Was that a yes or a no? Just out of curiosity. Or a neutral answer?

Bill Kelly

President

No. I think it’s a yes. There’s an appetite and our whole business strategy is geared towards filling up that appetite of pharmaceutical companies.

Robert Lazaros

Analyst · Robert Lazaros, private investor. Please proceed

Thank you.

Operator

Operator

And that does conclude the question-and-answer session. I’ll now turn it back to Walter Herlihy for closing remarks.

Walter Herlihy

President and CEO

Okay. I would thank you for joining us on our call today. And despite the difficult call environment, I think that I’ve said on the concluding of my remarks, we expect to not only survive, but thrive in 2009. And we look forward to continuing our communications to you. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Have a great day.