Earnings Labs

Repligen Corporation (RGEN)

Q3 2009 Earnings Call· Wed, Feb 11, 2009

$112.96

-3.81%

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Transcript

Operator

Operator

William Kelly

Management

Thank you and good morning. The purpose of today's call is to briefly review our financial results for Q2 fiscal year 2009, update our financial projections for fiscal year 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 the US sales of Orencia, opportunities for licensing, our intellectual property portfolio and our plans and 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 pre-clinical or clinical results or delays, delays in manufacturing by us or 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 third quarter of FY 2009, which ended on December 31, 2008. For the quarter, we recorded total revenue of $6 million, including product sales of $3.3 million and royalty and other revenue of $2.7 million. Our net income for the quarter was $18,000 and our cash and investments on December 31 were $64.5 million. Total revenue for the nine-month period ended December 31, 2008 was $24.8 million and…

Walter Herlihy

Management

Thank you, Bill. As a final point on Orencia, I would note that Bristol filed new clinical data with the FDA last quarter to support approval of its use in patients with early erosive rheumatoid arthritis. The application was based on a recently published study in 509 patients who had rheumatoid arthritis for less than two years and who had not previously received Methotrexate. Study compared one year of treatment with Orencia plus Methotrexate versus Methotrexate alone. At the end of the year, 41% of the Orencia plus Methotrexate treated patients achieved disease remission compared to only 23% of the Methotrexate group. Similarly, the Orencia group showed a significant reduction in disease progression based on radiographic assessment of selected joints. These data may enable Bristol to market Orencia for patients earlier in their disease pending FDA approval. Bristol has also recently indicated that Phase II data evaluating Orencia in psoriatic arthritis will be released at the American College of Rheumatology Meeting this year. We expect that an expanded label and continued news flow will support Orencia's continued sales growth. Turning now to our own pipeline, our Phase 3 trial of secretin in MRI imaging of pancreatic abnormalities is currently recruiting patients at 24 sites and there are approximately 135 patients in various stages of the trial. During the quarter, enrollment was somewhat slower than anticipated. In response, we have dropped several non-performing sites and added eight new sites which would help increase the enrollment rate. We believe we will complete enrollment in about six months. One of the critical assumptions powering our trial is the percentage of enrolled patients who actually have a pancreatic structural abnormality. Based on our Phase IIa data, we assumed that 55% to 60% of enrolled patients would have a structural abnormality. A review of the…

Operator

Operator

(Operator instructions) Our first question comes from the line of Elemer Piros [ph] with Rodman & Renshaw. Please proceed. Elemer Piros – Rodman & Renshaw:

Walter Herlihy

Management

Elemer Piros – Rodman & Renshaw: Okay, I would like some guidance if possible for revenue breakdown going forward between product and royalty revenues.

William Kelly

Management

We are not providing guidance at the moment for fiscal year 2010. However, for Q4, we see about 50/50 split of the total of about $4.8 million to $5 million in revenue. Elemer Piros – Rodman & Renshaw: For total revenue of $4.8 million to $5 million?

William Kelly

Management

For Q4, correct. Elemer Piros – Rodman & Renshaw: Okay, thanks. Can you give me any expense or net loss guidance for end of '09, since you are not giving 2010 guidance?

William Kelly

Management

We have increased our net income guidance for [ph] between $5 to $6 million and our SG&A spending, we expect to about $1.4 million and our R&D spending, we expect to be about $4.5 million. Elemer Piros – Rodman & Renshaw: Okay. And moving on to milestones, for the RG2417 trial, when do you expect to complete enrollment for that?

Walter Herlihy

Management

It's early days, of course, since we are just opening centers now. But, assuming we get enrollment rates that are similar to what we had in our Phase IIa trial, we expect the enrollment will take about a year to complete. Elemer Piros – Rodman & Renshaw: So, about a year from now?

Walter Herlihy

Management

Yes. Elemer Piros – Rodman & Renshaw: Okay. And what about the Phase III trial, any guidance as to when you plan on completing that trial? I guess you said you want to launch in second half of 2010.

Walter Herlihy

Management

Right. So we would expect to complete enrollment in this study in about six months. It then would take us one to two months to clean the data, lock it and then have the top line results, which would then be compiled into our NDA application either late this year or early next year. Elemer Piros – Rodman & Renshaw: Okay. Thank you very much.

Operator

Operator

(Operator instructions) And our next question comes from the line of Ronald Orphan [ph]. Please proceed sir.

Ronald Orphan

Analyst

Walter Herlihy

Management

Good morning.

Ronald Orphan

Analyst

I was wondering, is there any takeover offers in the future for our company? I have been with you for about 10 years now as a private investor.

Walter Herlihy

Management

We haven't disclosed any takeover offers that have been made. So I think that's certainly a possibility at some point in the future, but I think in the short-term that's unlikely.

Ronald Orphan

Analyst

Okay. Thank you very much.

Operator

Operator

William Kelly

Management

Operator

Operator

Thank you for your participation in today's conference. This concludes the presentation. Everyone have a great day.