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Furiex Pharmaceuticals Inc (NASDAQ:FURX)

Q3 2012 Earnings Call

November 2, 2012 9:00 am ET

Executives

June Almenoff – President and Chief Medical Officer

Marshall Woodworth – Chief Financial Officer, Treasurer and Assistant Secretary

Fredric N. Eshelman – Chairman of the Board

Sailash Patel – Vice President, Strategic Development

Analysts

Matthew Kaplan – Ladenburg Thalmann & Co.

Brian Lian – Suntrust Robinson Humphrey

Operator

Good day, ladies and gentlemen, and thank you for standing by, and welcome to the Furiex Pharmaceuticals Third Quarter 2012 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, today’s conference is being recorded.

I would now like to introduce your host, Mr. Sailash Patel, Vice President of Strategic Development. Please go ahead.

Sailash Patel

Good morning. Welcome to the Furiex Pharmaceuticals third quarter 2012 earnings conference call. Before we begin, I would like to remind everyone that our comments today contain forward-looking statements. All statements other than statements of historical facts are forward-looking statements including any statements concerning research and development, clinical development plans and timelines, regulatory approval timelines, revenue and financing expectations, and post financing of new or existing projects, proposed licensing or collaborative opportunities or agreements, any statement of assumptions underlying any of the foregoing.

Actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial conditions and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including the risk factors described in our Annual Report on Form 10-K and other SEC filings, copies of which are available from our investor desk and on our website www.furiex.com.

I will now turn the call over to our President and Chief Medical Officer, Dr. June Almenoff.

June Almenoff

Thank you, Sailash. Good morning everyone. Great to our business updates. Starting with MuDelta, as you know, this is a novel or locally active new agonist delta antagonist in development for treatment of diarrhea predominant irritable bowel syndrome, IBS-D. We believe that the dual activity on both Mu and Delta receptors enables the management of both the diarrheal as well as the pain symptoms in this condition without the constipating effect and tolerance that can occur with unapproved mu receptor agonist activity.

Janssen scientists recently published a paper in the British Journal of pharmacology summarizing the preclinical biology studies conducted with MuDelta and comparing its effect to those of loperamide. These two drugs behave differently in these preclinical studies supporting our clinical hypothesis that MuDelta will treat the diarrhea associated with IBS-D without the constipation associated with a pure new agonist such as loperamide. Reference to this publication is posted on our website furiex.com.

In June 2012, we commenced dosing patients with two parallel phase III pivotal trials. These trials are focused on the U.S. endpoints around dual consistently and pain over 12 weeks, but they also capture data on European endpoints obtaining global symptoms at 26 weeks which at positive quick support in EU submission. We reached our target of about 600 active sites in North America and further we expect to have about 50 studying sites in the UK which should all be active by years end.

Our target enrollment is 2,250 IBS-D patients and we recruited slightly more than 30% of the patients needed to complete these pivotal trials. One study will run for 52 weeks and the other for 3 weeks. We will collect efficacy data in both studies for 26 weeks to 30 weeks and safety data for the full duration of the trial. With the caveats that recruitment rates can fluctuate and that were still early in the recruitment process, our best estimate is that we will be able to report top line results of our 30 week phase III study in early 2014. We continue to evaluate those partnering and funding options to support the phase III development of MuDelta and we will share additional information if and when appropriate.

Next, a brief update on JNJ-Q2. This is a novel fifth generation quinolone with broad antimicrobial coverage including MRSA. We believe the product is ready for Q3 in both the acute bacterial skin and skin structure infections and pneumonia indications. In 2012, there were a total of 10 papers of abstract published on this molecule out there primarily scientific collaborates describing as microbiology, its preclinical and clinical from profiles.

We are continuing to look to partner or out license this product with the help of an investment bank. We continue to find the environment for antibiotic partnering challenging. There is minimal spend on maintaining its asset and at this time, we don’t plan to progress development without a partner.

Moving now to our marketed portfolio, we’ll start with alogliptin, which is partnered with Takeda. Alogliptin is a DPP-4 inhibitor that’s indicated for the treatment of type 2 diabetes. Nearly 10,000 patients have been treated with alogliptin in clinical trials. Since mid 2010, alogliptin has been marketed in Japan under the trade name Nesina. This past quarter, royalties to Furiex associated with sales in Japan increased over 63% compared to the prior quarter.

On the regulatory front, we understand that Takeda continues to make progress with regulatory submissions for alogliptin in the U.S., Europe and rest of the world. We anticipate an FDA decision on the U.S. NDA by the end of January 2013 and for the European MAA in the later half of 2013.

Now, riding up with Priligy. Priligy is dapoxetine is the only medicine that’s specifically approved to premature ejaculation. Approximately 9,000 men have received Priligy in clinical trials. It’s currently marketed in 15 countries ex-U.S. and approved in 56 countries including all major EU markets.

Our Priligy Asset Transfer from Janssen and our out licensing agreement with Menarini both became effective on July 31, 2012. As you know, this agreement gives Menarini commercialization rights for Priligy in Europe, Latin America most of Asia Pacific and Africa Middle East. The transition of Priligy from Janssen to Menarini and to Furiex is progressing as planned.

First, Janssen recently transferred the US IND to us, however at this time don't plan to resubmit the NDA as there is no clear regulatory guidance from FDA on acceptable study endpoints for premature ejaculation, and additionally our primary focus at this time remains on the MuDelta program. We’ll continue to monitor the situation and may reassess our strategy should circumstances change.

Second, Janssen is in the process of transferring country specific marketing authorization licenses to Menarini. These transfers are a key prerequisite needed by Menarini to launch Priligy. Based on the progress of the transition to date, we anticipate that Menarini will attain some or all of the launch milestones specified in our agreement within the first half of 2012. Furiex is eligible to receive up to $10 million when these launch milestones are attained.

This concludes the portfolio and business update, and now I will turn the call over to Mr. Marshall Woodworth for the financial update.

Marshall Woodworth

Thank you, June. With regard to the three months ended September 30, 2012, revenues for the quarter were $15.6 million comprised of $10 million in regulatory milestone payments associated with the new Priligy license agreement with Menarini and $5.6 million in royalty revenue.

Royalties were up over $2.5 million from the level recorded in Q2 of 2012 and up over $4.3 million from the level recorded in Q3 of 2011. The quarter-over-quarter growth in 2012 was positively impacted by higher Nesina and Liovel sales and economics associated with the Priligy transition.

Royalties associated with Nesina and Liovel sales increased over 63% when compared to the prior quarter. This was a result of higher product sales and a higher tier of royalty payments based on cumulative fiscal year sales. Our royalty rates for these products reset each April 1, the beginning of Takeda’s fiscal year, an increase during the Takeda fiscal year if cumulative fiscal year net sales reach sufficient levels. There was no deduction for IP cost sharing in Furiex syndicated during the third quarter as the Japanese sales are not fully unburdened as described in our Q2 earnings call.

Regarding Priligy, as previously announced, on July 30, we completed a License and Asset Transfer Agreement with ALZA and Janssen Pharmaceutica, a worldwide Priligy product rights and a license agreement with Menarini Group for Priligy commercialization.

Under the terms of the Asset Transfer Agreement with ALZA and Janssen, Furiex is obligated to pay Janssen a total of $15 million for transition services with $7.5 million due and paid in Q3, and $3.75 million due within 10 business days of the beginning of each of the two quarters, each of the following two quarters. $3.75 million of which was paid in October leaving an additional $3.75 million to be paid in January of 2013.

In addition, Furiex will be obligated to pay up to $19 million in potential cost associated with Janssen’s ongoing clinical studies for Priligy up to 1 million for reasonable out-of-pocket expenses over the transition period, and fees related to the product sales and distribution activities that Janssen will perform on behalf of Furiex during the marketing license transition period. Defined is the period of time that it will take to transfer individual country marketing licenses from Janssen to Menarini pursuant to a sales services agreement.

Under the terms of the license agreement with Menarini, Furiex received a $15 million upfront payment, $10 million of regulatory milestone payments in the third quarter and is eligible to receive up to $19 million to fund the Janssen’s ongoing clinical study for Priligy, up to $10 million in launch milestones and up to $14 million in sales based milestones, plus tiered royalties ranging from the mid-teens to the mid-20s in percentage terms. The tiered royalties associated with the Menarini License Agreement for Priligy will begin after the Janssen marketing license transition period is complete.

Additional clarification with regards to 1) a $15 million payment of Janssen for transition services, 2) the $15 million upfront payment from Menarini, and 3) up to $90 million to fund potential ongoing clinical study cost for Priligy including potential payments to Janssen and potential receipts from Menarini. The company is effectively and intermediary between Janssen and Menarini. It sets the company has not recorded amounts associated with the $15 million and up to $19 million payments within the consolidated statements of operations for the current quarter. However, certain portions related to these amounts are reflected within the consolidated balance sheets.

As of the end of the third quarter, the company had recorded within accrued expenses, the remaining amounts due Janssen associated with Priligy transition services of $7.5 million, in addition to recording approximately $2 million in both accounts receivable and accrued expenses related to the ongoing Priligy clinical study class being performed by Janssen that were occurred during the third quarter and are effectively being funded by Menarini.

In summary, as of the end of the quarter, there is approximately $2 million in accounts receivable that do not relate to royalties due Furiex, and approximately $9.5 million in accrued expenses that do not relate to ongoing research and development costs associated with our development pipeline.

Priligy royalties were positively impacted by the transition economics of the various agreements covering this transaction. These transaction economics added incrementally to the royalty that was recorded and will continue only during the marketing license transition period of the agreements. After the marketing license transition period is complete, Furiex will record tier royalties based on net product sales by Menarini from the mid-teens to mid-20s in percentage terms.

Our annualized royalty income based on sales in Q3 is just over $22.6 million. This calculation assumes that net sales of Nesina, Liovel and Priligy for a full year or at the same level as net sales recorded in Q3. Of course, we can’t control or predict Takeda sales, but if you’d like more information, I would refer you to Takeda’s recent quarterly earnings calls and associated sales projections, which can be found on Takeda’s website.

R&D expenses were $14.8 million for the quarter including $347,000 non-cash stock option expense. R&D spend was in line with our budget, which reflects the decision to move forward new drug development and related costs.

SG&A expenses were $3.2 million for the quarter including $900,000 in non-cash stock option expense. The $400,000 increase from Q2 2012 was primarily a result of higher consulting expenses incurred during the quarter. We expect our level of SG&A, which includes all of our public company cost to run between $2 million and $2.5 million per quarter on an ongoing basis.

On August 2, we signed an amended and restated debt agreement with MidCap and Silicon Valley Bank which provided for an additional $30 million in term debt along with the reset of the previous $10 million in principle outstanding with the same group. The agreement provides for interest only payments through August of 2013 and carries an interest rate of 10% per annum subject to adjustment and certain events. This facility was fully funded prior to the end of August.

At the end of the quarter, we had total current assets of $56 million including $55.4 million in cash, short-term investments, and accounts receivable. The accounts receivable balance includes a $2 million receivable from Menarini related to ongoing Priligy clinical trials.

Current liabilities excluding current portions of long-term debt were $19.9 million. These were comprised of accrued expenses related to development of MuDelta as well as $9.5 million related to transition services and ongoing clinical study cost to Janssen as previously described.

I'll now provide limited forward-looking financial guidance. Our forecasted total R&D spending, by total R&D spend I’m including all MuDelta cost which are Phase III studies manufacturing Phase I and non-clinical including cost associated with and limited cost associated with J&J-Q2 and other R&D in the absence of a partner for MuDelta for the remainder of the year is expected to run between $24 million and $26 million, comprised almost entirely of Phase III study cost, manufacturing non-clinical and Phase I cost related to MuDelta.

Previously, we had stated that, for MuDelta, our current plans are to progress forward with two Phase III studies as well as supporting studies and activities while continuing to seek a partner. For clarity, supporting studies and activities include cost for manufacturing non-clinical and Phase I studies.

Our forecasted total R&D spending, again that includes all MuDelta costs as well as limited cost associated with J&J-Q2 and other R&D, our forecasted total R&D spending for the next 15 months in the absence of a partner for MuDelta is expected to run between $105 million to $115 million comprised almost entirely of Phase III steady cost manufacturing non-clinical and Phase I cost related to MuDelta.

Although we have chosen not to provide guidance on revenue due to variable nature and timing of milestones in royalties, I do want to summarize information previously disclosed in our 10-Qs and 10-K as well as on various 8-Ks and press releases and on this call.

For Nesina, upon FDA approval for Nesina, we are entitled to receive a $25 million milestone and a further $10 million milestone based on approval in the EU. In addition to the potential milestone revenue, we are entitled to receive continuing royalties from sales by Takeda in Japan, and if approved and launched from sales by Takeda in other countries including the U.S. and Europe.

Finally, based upon achieving certain sales targets, we’re eligible to receive up to $33 million in sales based milestone payments. We don't make or endorse any other parties estimates, but if you want you could read the various disclosures by Takeda and a number of analysts projections as far as what sales from Nesina might be. As previously disclosed, our royalty rates in Japan are 4% to 8%, our royalty rates of 4% to 8% in Europe and 7% to 12% in the U.S.

For Priligy, as I indicated earlier, we are eligible for up to $10 million in launch milestones up to $40 million in sales based milestones and tiered royalties ranging from the mid-teens to mid-20s in percentage terms after completion of the marketing license transition period.

Based on our current forecast including the expected receipt of milestone and royalty payments, we expect to have sufficient cash to fund the business for the next 12 months. However, if one or more of the milestone events and or the expected growth in royalty payments fails to come to fruition, lot of expenses increased because of slower than expected enrollment rates or other factors, we will likely need to fund additional sources of financing to support our Phase III efforts in the absence of a partner.

We will of course closely monitor our cash balances and might seek to obtain funding from additional sources including but not limited to partnering income, royalty financing, debt or equity as we believe necessarily and desirable.

This concludes my remarks. And I'll now turn the call over to Dr. Eshelman.

Fredric N. Eshelman

Thank you, Marshall. We are certainly moving the ball forward here at Furiex. The MuDelta development program remains on track as you heard. Nesina royalty revenue from Japan continues to ramp up, Takeda has resubmitted the NDA’s for alogliptin and the combination product to the FDA. Restructuring of the Priligy agreements is complete, and immediately accretive, and we have secured $30 million in additional funding to support operations. We believe we have and continue to lay a sound foundation for the development of our product portfolio and the good health of our company.

I will turn it back to you Dr. Almenoff.

June Almenoff

Thanks, Fred. Before we take questions, I do want to make a quick clarification on one of my prepared comments. We anticipated to launch milestone for Menarini would occur in the first half of 2013, rather than 2012. Okay, operator we could open the line for Q&A.

Question-and-Answer Session

Operator

Yes, ma’am. (Operator Instructions) Our first question comes from Matt Kaplan with Ladenburg Thalmann. Please go ahead. Your line is open.

Matthew Kaplan – Ladenburg Thalmann & Co.

Hi, good morning guys. Can you hear me?

Marshall Woodworth

Yeah. Matt, thank you.

Matthew Kaplan – Ladenburg Thalmann & Co.

Thanks, I have a few questions, and congratulations I guess first on the progress you made, especially launching the Phase III studies and the enrolment that have achieved so for. I guess with respect to MuDelta, can you maybe talk about a little bit about the safety profile of the drug with specific focus on pancreatitis. And I guess how you are controlling for this in the Phase III. And I guess do you expect to see any pancreatitis in Phase III at this point?

June Almenoff

During the Phase II program, during the treatment phase, we saw two cases that were associated historically with alcohol use and one case that occur within just a few hours of patient taking the drug. And we believe that that later case is likely to be sphincter of oddi spasm which occurs with [dossier] and the first two uncertain about the causality, but certainly alcohol and in fact prior pancreatitis was situation in one case. So with that said, it’s obviously something we take quite seriously and already in the Phase II program, we made some protocol amendments and we’ve actually continued those and let me just summarize what we are doing in Phase III.

First, we are excluding peoples who have marked abnormalities of serum lipase, and lipase is a pancreatic enzymes and it’s often elevated in pancreatic diseases in pancreatitis.

Secondly, we are excluding patients who have medical risk factors for pancreatitis. So and obvious history through verbal reports, medical record review of alcoholism or binge drinking a history of active gallbladder, or biliary tract diseases or recent surgery in that anatomic area. Also, although we’re not explicitly excluding individuals with very high triglycerides, certainly measuring these prior to enrollment as they can sometimes be associated with pancreatitis.

So that is what we are doing to manage risk, we closely monitor the safety of our program online data and obviously can’t disclose safety information also through this time.

Matthew Kaplan – Ladenburg Thalmann & Co.

And I guess in relationship to that do you have regular DSMB looks, are they scheduled. DSMB look as you go through the trial?

June Almenoff

So we have put together an expert adjudication committee of both pancreatic compatibility and safety expert. And they do review the cases, but they are – unless our case in particular would be unblinded for regulatory reporting reason. This is not a DSMB unit actually unwinding specific data, they are basically reviewing the data commenting on the cases and providing us advice.

Matthew Kaplan – Ladenburg Thalmann & Co.

Great, thanks. And I guess in relationship to MuDelta, can you give us an update on your partnering activity with respect to the program?

June Almenoff

Yeah, obviously we can’t disclose too much detail, but it continues to occur, we are in diligent and detailed discussions with several good potential partners and obviously it would not be over till it’s over, so we will be expectedly optimistic, but need to obviously consider the economic return of the timing.

Matthew Kaplan – Ladenburg Thalmann & Co.

How would you expect a potential partnership to look what it would be, I guess regionally specific or the worldwide or what’s your sense at this point?

June Almenoff

Yeah, I mean basically conversations we’re having, we’re looking at various types of options both global and regional.

Matthew Kaplan – Ladenburg Thalmann & Co.

Are you leaning in one direction?

June Almenoff

I think mostly the economics would drive that decision, the economics and the capability of the partner.

Matthew Kaplan – Ladenburg Thalmann & Co.

Good, and thank you for I guess all the detail in terms of the current expected R&D expenses over the next 15 months. Any plans right now to address those – address your cash needs with respect to monetizing the Nesina Royalties or some other plans?

Marshall Woodworth

No we are always and have been continuing to look at that both monetizing the Nesina royalties as well as other options and opportunities, and we did execute on one of those last quarter when we took them of $30 million and reset the term loan, the original term loan that we had, which we believe optimized our balance sheet and our cash position at that point of time and put us in a good position to proceed forward to the next decision point. And so we continue to have those discussions both internally and with our Chairman and with the Board and as events unfold we will take appropriate action to maintain a robust cash balance moving forward.

Matthew Kaplan – Ladenburg Thalmann & Co.

I guess what’s the projections that you gave in terms of, you expect to have 12 months of cash or cash on hand and the visibility that you have to the milestone payments from the various programs. How conservative is that? Could you have – these 12 months are conservative estimate or what’s your sense now?

Marshall Woodworth

Well, the 12 months, interestingly, 12 months is more an accounting convention, but it is an important data point for everybody both the investors and the turnover look at. It is predicated the assumptions that I outlined, which are highly influenced as you can understand by the milestone recedes and by the royalty – potential royalty recedes. So it’s very much influenced by the $25 million on the U.S. filing and the $10 million on – the U.S. approval and the $10 million on the European approval as well as continued royalties for both Nesina and Priligy. So those are some of the events that we keep in active ion and look and make contingency plans around either a positive outcome or a negative outcome and we do continue to have internal discussions and contingency plans around both of that or all of those events.

Matthew Kaplan – Ladenburg Thalmann & Co.

I guess one last question and I’ll jump back in the queue. Last question, with respect to your projections for Nesina royalty ramp up, are you just assuming us a flat royalty number with this quarter going forward in your assumptions when you say 12 months or do you – is there an anticipated certain ramp in the royalty rate?

Marshall Woodworth

Matt good question, and that’s why I thought the guidance on what the earlier or the annual royalty rate would be with no increase in sales of either Priligy or Nesina, those are important data point for people to have. Out internal forecast we do everything from assuming a flat royalty which would mean no increase in sales with both Nesina and Priligy going forward, all the way up to using the forecast provided publically by Takeda and they just disclose what they thought their fiscal year 2012 forecast would be for Nesina. On their Q2 earnings call, which just a place as well as projections from our partners in terms of what they think they can do in terms of sales.

So, there is the continuum there, but to your point and to your question about the next 12 months, the conservative look would to take the royalties flat with what had already occurred or the sales flat with what have already occurred in Q3 and project those forward with no increase. And using that assumption, as well as these milestone payments, we still have enough cash for the next 12 months.

Matthew Kaplan – Ladenburg Thalmann & Co.

Great. Thanks again and congrats on the progress.

Operator

Thank you, sir. Our next question comes from Brian Lian with Suntrust. Please go ahead, your line is open.

Brian Lian – Suntrust Robinson Humphrey

Hi, good morning. Thanks for taking the questions. June, I just had a quick question on the Phase II MuDelta program, was there an extension portion to the Phase II trial, and if so, where there any key cases that pancreatitis observed in the extension.

June Almenoff

What do you mean by an extension, do you mean an open label (inaudible)?

Brian Lian – Suntrust Robinson Humphrey

Right, rotations allowed to continue on a therapy pass the endpoint to the study.

June Almenoff

No, there was not.

Brian Lian – Suntrust Robinson Humphrey

Okay. And then I know earlier in the week, Takeda lowered their fiscal Nesina sales estimate to around $475 million from about $600 million previously. Do you have any color on that, on reasons why the prior guidance was a little bit higher than the revision?

Marshall Woodworth

Yeah, I would say the best indications and the best colored commentary around that, if you listen to Takeda’s earnings call, which is out in the website, I think it’s Q&A number five, that they go at legs into the reasons why they do not believe that they will keep their original ¥48 forecast and that they’ve reset that lower by 20% for the current year – current fiscal year by roughly 20% to ¥38 billion. They stayed I think eight to ten different reasons. I would encourage you to listen to that dialogue, because that is probably the best indication and the best color commentary around where Nesina sales will be going in the short-term.

June Almenoff

Yeah just quickly add on some top line points that they made, number one they indicate that Nesina in Japan is growing at the rate of 10% to 20% greater than the competition. And secondly, they made a point that they believe that over the next number of months, they should be able to be – able to get their sales force more, or able to – could put more resource on to Nesina.

Brian Lian – Suntrust Robinson Humphrey

Okay. Can you give any color as that to how they are positioning it in Japan, I mean it wasn’t the first DPP-4 inhibitor, it is not the only one, but the ramp I think is reasonably strong. Is it market expansion or is there some differentiating message that might work in the U.S. as well?

June Almenoff

It think that Japan given the fact that they have not completed the cardiovascular outcomes study, there is not an ability to differentiate on efficacy or safety. However, they certainly have a very large number of combined use indications and fixed dose combinations.

Brian Lian – Suntrust Robinson Humphrey

Okay. And then the last question on the Silicon Valley and mid cap loans, are there covenants around required cash levels?

Marshall Woodworth

There are, and you will see that the $7.5 million in short term investments is in effect one of those covenants. So those covenants decline over time, $7.5 million is what we’re required to maintain in a cash balance currently, but that does decline over time.

Brian Lian – Suntrust Robinson Humphrey

Okay. Thanks very much.

Operator

Thank you, sir. (Operator Instructions) One moment. Presenters I am not showing any further questions at this time. I would like to turn the program back over to June Almenoff, President and Chief Medical Officer for any concluding remarks.

June Almenoff

I would like to thank everyone for joining our call today, for your interest and support of Furiex, and we look forward to speaking on our next conference call. I’ll turn the call back to the operator.

Operator

Thank you ma’am. Ladies and gentlemen, thank you for your participation in today's conference. This does concludes the conference, you may now disconnect. Everyone have a wonderful day.

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