Infinity Pharmaceuticals Inc (INFI) 2010 Q1 法說會逐字稿

Good day ladies and gentlemen and welcome to the Infinity Pharmaceutical first quarter 2010 results conference call. At this time all participants are in listen-only mode. Later will we conduct a question and answer sessions and instructions will follow at that time. (OPERATOR INSTRUCTIONS) As a reminder, this conference is being recorded.

I would like to introduce your host for today's conference, Mr. Gerald Quirk, VP of Corporate Affairs and General Counsel. Sir, you may begin.

Thanks Francesca and good afternoon, everyone. Welcome to today's call. This is Gerald Quirk, Vice President of Corporate Affairs and General Counsel at Infinity. With me here today are Adeline Perkins, our President and Chief Executive Officer, Julian Adams, our President of R&D and Chief Scientific Officer.

In today's call, we'll be discussing our recent R&D and business highlights and reviewing our first quarter 2010 financial results.

The press release detailing our results was issued earlier today and is available on our website at infi.com. During this call, we may make forward-looking statements about our future expectations and plans, including clinical development milestones and financial projections. It's possible that our actual results may differ materially from what we project today, due to the factors described in the Risk Factor section of our most recent Form 10-Q we filed earlier this afternoon.

While these forward-looking statements represent our views as of today, they should not be relied upon in the future as representing our then-current views. We may update these statements in the future, but are not taking on an obligation to do so.

Let me now turn the call over to Adeline to kick us off. Adeline?

Thanks Gerald and good afternoon everyone. Thanks for joining us today. Before diving into recent R&D highlights and our first quarter financial results, I'd like to start our call today by sharing with you my vision for Infinity as a fully integrated biopharmaceutical company with world-class scientific, medical, business and commercial capabilities and great products.

The four pillars of which we will achieve this vision are - an exceptional team, a diverse product portfolio, full ownership and commercialization rights to all of our oncology drugs in the US, and a very strong financial position.

Let me now elaborate on each of these four pillars. The first is our commitment to maintaining a portfolio of drug candidates. Since inception we've been disciplined in adhering to a portfolio of strategy to ensure that Infinity's success is not dependent on any single product or indication. As our pipeline matures, we are increasingly reaping the rewards and addressing new challenges of managing and optimizing a full portfolio.

We have four drug candidates in clinical development, all with broad therapeutic potential providing us with many more development opportunities than we can practically pursue. This requires that we regularly prioritize the most compelling development paths and ensures that we're always working on those with the greatest potential.

The second pillar is our commitment to commercialize our drugs which is critical to not only retaining value but even more importantly to maximizing the value of our products. Control over commercial prioritization and positioning is essential to realizing our drug's full potential.

In an increasingly competitive marketplace, it's imperative that we incorporate true market insights early in development with specific labels in sight, the right indications, lines of therapy, combinations and endpoints.

By virtue of the way that each of our drugs work, they have broad therapeutic potential and multiple possible development paths. Selecting among those paths require that we integrate along with clinical data and market dynamics and react nimbly and refine our development and commercial strategies.

Delivering differentiated products that meet changing patient needs requires differentiated commercial insights and capabilities. We have begun building a small but dynamic commercial organization that brings tremendous experience in the marketing of successful oncology drugs to Infinity and which is helping us define how to best differentiate both our commercial organization and our products.

The third pillar, and a fundamental cornerstone of our strategy is attracting and retaining the very best people, our citizen owners. One of the most compelling hallmarks of great biotech companies is their people. At Infinity we've built a fantastic team and developed a culture that enables each person to achieve their full potential. We treasure our team and culture, never taking either for granted, as they provide our most significant and sustainable sources of competitive advantage.

A testament to the environment we have created is the recent acknowledgement by the "Scientist Magazine" for the sixth straight year naming Infinity as one of the best places to work in the industry. I, for one, couldn't agree more.

And last, but certainly not least, is having adequate capital to aggressively pursue our portfolio and build a company. Our financial strength with cash into 2013 is no accident. We have employed and will continue to employ a range of capital raising tools to ensure our continued financial strength as we prosecute our pipeline.

We have minimized dilution in our shareholder base and retained long-term value in our products by balancing the use of equity and product rights to raise capital at the right price and time.

In summary, 2010 is an important year for us as we continue to advance our pipeline, build our team and evolve our Company. We're in a strong position today with four distinct candidates in the clinic, full ownership of our oncology products in the US, attractive royalties on X-US sales, a great partner in Purdue and Mundipharma, a phenomenal team of citizen owners and $310 million in cash, available capital and committed research funding giving us a cash runway into 2013 even as we aggressively invest in and advance our pipeline.

Building on our strength through the remainder of the year, we intend to complete phase I development of IPI-940, complete and report data from our phase I study of IPI-926 and advance our phase II study in metastatic pancreatic cancer, report data from the phase II studies of IPI-504 and initiate a second phase I study with and report phase I data on IPI-493.

So 2010 is a year that will be all about results on the path to achieving Infinity's vision for patients, citizen owners and shareholders.

And with that I'll pass the call over to Julian to run through our clinical pipeline and recent highlights. Julian?

Thanks Adeline. Let me first state to the newly initiated clinical trial with IPI-926 our oral hedgehog pathway inhibitor in patients with pancreatic cancer. This clinical trial builds upon a growing body of preclinical data that we have generated demonstrating that 926 increases the vascularity of pancreatic tumors rendering them more accessible to chemotherapy.

Based on these data, we launched a randomized study evaluating IPI-926 in combination with gemcitabine in patients with metastatic pancreatic cancer. The first portion of this study has a run-in dose escalation of IPI-926 in combination with full dose gemcitabine to establish safety. After that we'll move directly into the randomized, double-blind portion of the study.

The primary endpoint is overall survival and secondary endpoints include progression-free survival, time to progression and overall response rate.

Additionally, we have presented a robust set of preclinical data of 926 and expect to present data from the ongoing phase I study including safety, biomarkers and the PK/PD relationships in patients with solid tumors later this year.

Moving next to our Hsp90 chaperone inhibitor program, let's start with our IV agent, IPI-504. 504 is currently in two phase II trials, one as a single agent in patients with advanced nonsmall cell lung cancer and the other in combination with Herceptin in patients with HER-2 positive breast cancer.

We completed enrollment of the lung cancer study in 2009. At that time we undertook an effort to better understand the molecular characteristics of the responding patients in this study. We've yielded some very interesting results which will be presented with the final data during ASCO.

Turning to the breast cancer study, we expect to evaluate interim data in the near term. These analyses will help us determine how our IV agent fits into our Hsp90 development strategy and how our overall product portfolio going forward. We anticipate reporting preliminary data from the breast cancer study by the end of the year.

In addition, we are actively enrolling patients in a phase I study of our oral Hsp90 chaperone inhibitor, IPI-493. The oral availability of 493 may provide us with some distinct advantages in terms of flexibility in dose and schedule and combination potential with other agents. This is a dose escalation study in patients with advanced solid tumors to evaluate the safety and tolerability of IPI-493 and to determine the optimal dosing schedules for phase II development.

We also anticipate commencing enrollment in a second phase I study of IPI-493 in patients with advanced hematologic malignancies in the near future and presenting preliminary phase I data on 493 later this year.

Let me finish with a brief highlight on our fourth clinical candidate, IPI-940 for the potential treatment of neuropathic and inflammatory pain. IPI-940 is designed to potentiate the endogenous pain relief molecule, anandamide, by inhibiting the enzyme fatty acid amide hydrolase or FAAH. Our novel oral agent is moving steadily through phase I development. This includes a single ascending dose and multiple ascending dose studies in healthy adult volunteers.

The objectives are to evaluate the safety, tolerability as well as the PK and PD properties of 940. The phase I program is progressing as planned and we are on track to hit our goal for completing phase I development by the end of the year.

So it's been a busy year at Infinity and the rest of the year is shaping up to be the same. We're focused on generating the data needed to continue to move our programs and molecules forward.

And now let me hand over the call to Gerald to wrap up with our financial results. Gerald?

Thanks Julian. As you've all just heard, we have a compelling commercial vision, a talented and committed team and a portfolio of innovative drug candidates at varying stages of clinical development. Let me review our financial results and break down our financial position in more detail.

We ended the quarter with $126.3 million in cash and investments and notably, no debt. Our total revenue for the quarter was $16 million, all of which relates to our global alliance with Purdue and Mundipharma on the development of our hedgehog pathway and FAAH inhibitor programs, as well as our discovery pipeline.

Our R&D expense was $19.4 million reflecting reimbursed amounts by Purdue and Mundipharma on our partnered programs as well as our investment in our Hsp90 program. And we had a net loss of $8.4 million for the quarter.

So today we're financially secure to aggressively and prudently invest in our clinical pipeline in order to achieve our vision. Our partnership with Purdue and Mundipharma is going great and it provides us with committed R&D funding of up to $65 million in calendar 2010 of which we've already received $16 million in cash and $85 million in 2011 for all but our Hsp90 programs.

In addition, we have access to a $50 million line of credit for Purdue which we can use for any business purpose.

We began the quarter with access to $310 million to invest in our current and future pipeline on a low share count of 26 million shares or more simply put, approximately $12 per share.

Our cash and investments, committed R&D funding and proceeds from the line of credit are sufficient to fund our operations into 2013 based on our current operating plan. This enables us to continue advancing our pipeline to reach key development milestones and also evaluate external opportunities to strategically enhance our portfolio of broadly applicable targeted therapies.

And with that, let me turn the call over to Francesca for Q&A.

Thank you. (OPERATOR INSTRUCTIONS). And our first question comes from Eun Yang with Infinity. Your line is open.

Hi. It's Eun Yang from Jeffries actually. Just on 926, what prompted your guys to start the phase I/II in pancreatic cancer before we saw any data from the phase I solid tumor study? Was that based purely on preclinical data or did you guys see something positive in that phase I study?

So we have reached our maximum tolerated dose in the phase I study and are in the expansion portion of that study. Our preclinical data are so compelling that it prompted us to accelerate the development of the 926 in pancreatic cancer.

So I will remind you of the science paper we published last year where we showed a survival advantage in a genetic model of pancreatic cancer, again some of the best data I've seen in a mouse model. And this has emboldened us to go forward aggressively in pancreatic cancer.

And the way our phase I trial was designed with advanced solid tumors, we're going to have small numbers of specific tumor types so we are not looking to our phase I to direct our phase II development. Our phase I is really to find the right dose and schedule and as Julian said, the directions that we're taking for phase II is really driven much more by our preclinical work.

Okay, that's really helpful. And on 504 for lung cancer, I guess you -- before you guys had mentioned that you were going to start additional studies this year. Are we still on track for that or will that largely depend on the data at ASCO?

I think we'll be able to talk about that more after the ASCO presentation and our strategy in 504 will become clear. As you know, it's part of a broader portfolio in Hsp90 and we're making decisions as we go along and analyze al the data not only the lung cancer study but also the breast cancer study.

All right, thanks very much. I'll hop back into queue.

Thank you. And our next question comes from Ted Tenthoff with Piper Jaffray. Your line is open.

Great, thank you very much. Quick question just on the Hsp90 program, you guys had mentioned a liposarcoma trial earlier this year. I didn't see anything on that but I may have missed it, so is that ongoing? Is that something you're going to continue to pursue?

Yes, well Ted we had talked about a liposarcoma trial and we prioritized in the first half of the year our focus on the lung and the breast so that's where we have been in development and as we get data from those trials we'll look at the data with respect to our mini portfolio within Hsp90 on the breast/lung data as well as IPI-493 and decide what's the best way to take the program forward.

Understood, that's helpful. I'm a lot more excited about 926 as well so how quickly do you think we could get to data from the gemcitabine study and would you and Purdue envision starting additional phase II combo studies next year?

So we haven't given any guidance on how long the studies take. The study just initiated and we're in the phase I safety portion of the study and we can't project how long that will take, but once we get all the sites up and rolling in the phase II portion, we'll probably have a better sense of that in the future.

Excellent. Well, I look forward to that data. It'll be really exciting.

Thank you.

As do we.

Thank you and we do have a followup question from Eun and your line is open.

Okay, thanks for taking my followup. Just looking, if I recall correctly, I think Purdue budgeted $65 million in R&D spend for you guys this year. Looking at the run rate of reimbursement this year or this quarter, the $16 million, you're already pushing the upper end of that. Is there a possibility that they could actually expand that budget for 2010?

We really work hard to maintain, to work within the budget that we set and we've got a pretty good track record of the managing our resources and our investments so we fully expect that we'll come in at the $65 million and then as you know, there's committed budget for next year of $85 million and I think one of the things we really focus on our relationship is living within those means and we expect to do so.

Okay, thank you.

Thank you and I'm showing no further questions at this time.

Okay. Thank you operator. As we convene today, we're on track to meet our bold objectives for 2010. This will be an important year for us as we continue to advance our pipeline of innovative agents, maintain our financial strength and build our core capabilities such as commercial infrastructure.

I see that we have a number of shareholders and analysts on the call this afternoon. We thank you for your ongoing support of Infinity and I also want to thank Infinity's 180 citizen owners for their dedication, innovation and contributions to Infinity's ultimate goal - developing and delivering to patients important new medicines that will make a meaningful difference in their lives.

Thank you all again.

Ladies and gentlemen, thank you all for participating in today's conference. This does conclude the program. You may all disconnect and everyone have a wonderful day.