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Arena Pharmaceuticals, Inc. (NASDAQ:ARNA)

Q3 2012 Results Earnings Call

November 6, 2012 5:00 PM ET

Executives

Cindy McGee - Vice President, IR and Alliance Management

Jack Lief - President and CEO

Craig Audet - Senior Vice President, Operations and Head, Global Regulatory Affairs

Robert Hoffman - Chief Financial Officer

Dominic Behan - Chief Scientific Officer

Analysts

Matt Lowe - JPMorgan

Lee Kalowski - Credit Suisse

Ted Tenthoff - Piper Jaffray

Thomas Wei - Jefferies

Steve Byrne - Bank of America

Alan Carr - Needham & Company

Operator

Good day, everyone. And welcome to Arena Pharmaceuticals’ Corporate Update. This call is being recorded. At this time, for opening remarks and introductions, I would like to turn the call over to Arena’s Vice President of Investor Relations and Alliance Management, Ms. Cindy McGee. Ms. McGee, please go ahead.

Cindy McGee

Welcome and thank you for joining us. On today’s call we will review our third quarter financial results and provide a corporate update. Our update will include details of our collaboration with Ildong for South Korea that we just announced today.

Prepared remarks will be provided by Jack Lief, our President and Chief Executive Officer; Craig Audet, our Senior Vice President of Operations and Head of Global Regulatory Affairs; and Robert Hoffman, our Chief Financial Officer. Dominic Behan, our Chief Scientific Officer, will also be available to address your questions.

During this conference call, we will make forward-looking and other statements about our vision, views, goals, plans, expectations and future activities and events, including statements about BELVIQ and our drug candidate, including with regard to efficacy, safety, potential and future research and development, current and future collaborations, the regulatory process, commercialization and other statements that are not historical facts. Such statements may include the words plan, will, expect, believe, may, could, would or similar words.

You are cautioned to not place undue reliance on these forward-looking statements, which are only predictions and reflect the company’s beliefs, expectations and assumptions based on currently available information and speak only as of the time they are made. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995.

Risks and uncertainties that could cause actual results to differ materially from those described in our forward-looking statements include, drug development, the regulatory process and commercialization are uncertain, data and other information related to drug and drug candidates may not be as expected, favorable or sufficient for further development or commercialization, the results of our current collaboration and ability to enter into additional collaboration, the timing, outcome, uncertainly and cost of research and development, the regulatory process, manufacturing and commercialization, and other risks identified in our SEC reports. For a discussion of these and other factors, please refer to the Risk Factors in our SEC filings.

I will now turn the call over to Jack.

Jack Lief

Thanks, Cindy. This is a busy and exciting time at Arena as we prepare for the launch of BELVIQ in the United States, pursue regulatory approval in marketing, collaborations for BELVIQ in additional territories and advance our earlier stage drug candidates.

The most significant event in our history is about to occur, the availability of our first internally discovered drug BELVIQ. So, first, I’d like to review our long-term vision for Arena.

I believe BELVIQ as a single agent will be an important treatment option that benefits physicians and patients in their efforts for successful chronic weight management. BELVIQ will be effectively commercialized around the world through strategic marketing and supply collaborations.

Our research and development will establish BELVIQ as a safe and effective treatment in combination with agents such as phentermine and metformin. BELVIQ will also be developed as a treatment for additional indications such as smoking cessation and independently or in collaboration, we will successfully develop our pipeline to deliver best-in-class treatments for a number of diseases.

Most importantly, we plan to realize our vision in a profitable manner that returns value to our stockholders. This means striking the right balance between pursuing development opportunities and managing expenses in light of BELVIQ revenue and shared costs with our collaborators. We thank you for your support, as we move forward on this exciting path.

On today’s call, Craig will provide updates on BELVIQ launch activities and our regulatory efforts and Robert will review our financials. I will then outline our plans to realize the global potential of BELVIQ, including through strategic collaborations with Ildong of South Korea.

Lastly, before opening the call to your questions, I will discuss the advancement of our pipeline and review our upcoming milestones.

I will now turn the call over to Craig.

Craig Audet

As Jack mentioned, we’re working with Eisai to prepare for the U.S. launch of BELVIQ, following the completion of DEA scheduling. We are waiting the DEA’s publication of its recommended scheduling designation in the Federal register, which will mark the beginning of the 30-day public comment period. After this period, the DEA will address any comment it receives and publish its final scheduling decision.

In order to enable the availability of BELVIQ for patients as quickly as possible, following completion of the scheduling process, I’m pleased to report that we have recently delivered a portion of the U.S. launch supply to Eisai.

Our colleagues at Eisai believe BELVIQ will be one of the most important compounds in the history of their organization, based on the drug’s strong marketing position. Eisai is focused on delivering increasing sales of BELVIQ each year by expanding its sales force, following the initial market penetration and improved reimbursement.

They have created a dedicated specialty sales force of approximately 200 representatives, who have successfully sold Aciphex for GERD. These representatives will target -- will initially target about 30,000 physicians, including cardiologists, endocrinologists, internal medicine, obesity specialists and high-value primary care. Eisai has realigned its sales force structure to focus on the U.S. territories with the highest need for obesity treatment and the largest concentration of treating specialists.

As we await DEA scheduling, Eisai is working to establish a robust payer market. First, they are approaching employers to address the concerns about rising healthcare costs and lower productivity due to obesity and its related comorbid conditions.

In addition, Eisai is meeting with commercial and government payers to discuss the direct benefits of weight loss and weight management in reducing incidence of hypertension and diabetes. We are extremely pleased by the proactive nature of these discussions.

Beyond the U.S. launch activities, we are progressing with our marketing applications in the European Union and in Switzerland. With regard to the EU, I’m happy to say that we submitted our response to the CHMP the 120-day assessment report in October.

Therefore, we expect to receive the day one [EU] assessment report early next year. At that point, the CHMP will provide us a list of outstanding issues, should there be any. We continue to expect a final decision on our EU application in the first half of 2013. The final decision on our Swiss application is also expected in that same time period.

Lastly, in addition to planning for the required cardiovascular outcomes trial and the pediatric program, we have made progress with plans to assess the safety and efficacy of BELVIQ in combination with one or more other agents, as well as for new indications.

We plan to discuss these programs with the FDA to get their feedback and determine our next steps. After these discussions and the subsequent finalization of the development programs, we will provide you with details about these potential new opportunities for BELVIQ.

Robert will now provide you with a financial update.

Robert Hoffman

Thanks, Craig. I will focus my comments and highlight the financial performance for the nine months ended September 30, 2012, compared to the nine months ended September 30, 2011.

I also refer you to today’s financial news results release, as well as Form 10-Q we will file later this week. For the following financial results, 2012 will refer to the first nine months of 2012 and 2011 will refer you to the first nine months of 2011.

We recorded revenues of approximately $25.7 million for 2012, compared to revenues approximately $10.6 million for 2011. 2012 revenues included a $20-million milestone payment from Eisai for the inclusion of the BLOOM-DM data in the FDA-approved prescribing information for BELVIQ.

Research and development expenses for 2012 decreased to $40.2 million from $45.6 million for 2011. R&D expenses for 2012 included $1.2 million in non-cash share-based compensation expense compared to $1.5 million for 2011.

General and administrative expenses totaled $19 million for both 2012 and 2011. G&A expenses for 2012 included $2.4 million in non-cash share-based compensation expense, compared to $1.3 million for 2011.

Our net loss applicable to common stockholders decreased to $67 million for 2012, compared to $87.8 million for 2011. Cash and cash equivalents totaled $165.8 million at September 30, 2012, compared to $57.6 million at December 31, 2011.

At September 30, 2012, we had approximately 217.2 million common shares outstanding, warrants to purchase 3.4 million shares of common stock with an average or exercise price of $6.23 per share and stock options to purchase 13.4 million shares of common stock at an average or exercise price of $4.25 per share. None of Deerfield’s former warrants to purchase shares of our common stock remained outstanding as of September 30, 2012.

Although, the timing remains uncertain, for purposes of providing full-year 2012 financial guidance, we continue to assume that we received final DEA scheduling in 2012. Our financial guidance is as follows.

Full-year 2012 revenue guidance continues to be $91 million to $97 million, which includes the amortization of the $5 million upfront payment from Ildong. This revenue guidance also includes $65 million from Eisai following DEA scheduling.

If we do not receive DEA scheduling in 2012, we’d expect our revenues for 2012 to be $65 million lower. This guidance does not include any of the revenue under our marketing agreement with Eisai, such as product sales of BELVIQ or from any new collaboration we entered into in 2012.

Full-year 2012 R&D expenses guidance continues to be approximately $57 million to $67 million, including non-cash expenses that totaled approximately $6 million.

Full-year 2012 G&A expenses guidance continues to be approximately $20 million to $24 million, including non-cash expenses of approximately $2 million. We also continued to expect to spend approximately $2 million for capital expenditures for all of 2012, primarily related to our manufacturing facility in Switzerland.

Although, our guidance continues to assume that we may receive DEA scheduling in 2012, it appears unlikely that we will receive payment this year for the $65 million milestone, which is due 30 days after achievement. Therefore, based on this timing issue, we are revising our guidance for year-end 2012 cash and cash equivalents to total approximately $165 million.

This revised guidance includes a $5 million upfront payment from Ildong, as well as the payment for the October delivery of a portion of the BELVIQ launched by Eisai. Assuming DEA scheduling is in late 2012, we’d expect to receive the $65 million milestone payment in early 2013.

I will now turn the call back over to Jack.

Jack Lief

Thanks, Robert. We are well-positioned to deliver significant value to our stockholders by executing on the potential of BELVIQ, and selectively advancing our pipeline of internally discovered drug candidates.

In May, prior to FDA approval of BELVIQ, we expanded our collaboration with Eisai from the U.S. only relationship to include most of North and South America. This agreement, pending applicable regulatory approval provides commercial access to key markets, including Canada, Mexico and Brazil. We continue to evaluate and as warranted, pursue strategic collaborations that support BELVIQ’s development and approval and commercialization in additional territories worldwide.

In certain territories, such as the EU and Switzerland, Arena will lead the regulatory process while seeking a collaborator with commercial expertise. For certain other territories, we will seek collaborators that offer development in regulatory and commercial expertise in the specific region.

We also expect collaborators to pay for the majority of any required development in their territories. For example, Eisai is responsible for obtaining 90% of the U.S. cardiovascular outcome trial, and 90% of any required development in the remainder of North and South American territories.

With this strategy in mind, we are pleased to collaborate with Ildong Pharmaceutical to address the significant, unmet medical needs for new obesity treatment in South Korea. Ildong was founded over 70 years ago, and has become a leading pharmaceutical company in South Korea, which is among the top 15 pharmaceutical markets in the world.

To effectively address this dynamic market, many multinational organizations seek collaborations with local Korean companies. Ildong has active long-term alliances in place, including with Ajinomoto, Shionogi and Pfizer.

These collaborations involve global products that are supported in Korea by Ildong’s commercial organization, which spans a wide range of therapeutic areas. For example, FASTIC, a diabetes drug Ildong licensed from Ajinomoto is marketed in the U.S. and Europe by Novartis, under the name Starlix.

Ildong has also licensed antibiotics, Finibax, Flumarin and Flomax from Shionogi. Finibax is marketed in the U.S. as Genzyme Doribax 16:12. With BELVIQ, Ildong looks forward to addressing the medical management of obesity.

In South Korea, approximately one third of the adult population is classified as obese, which is locally defined as a BMI greater than or equal to 25. In 2009, the market for obesity drugs in South Korea totaled approximately $90 million, or about 25% of the U.S. market at that time.

Following withdrawal of sibutramine in 2010, the South Korea obesity market decreased by nearly 50% in 2011. Under the agreement, we will receive an upfront payment of $5 million, and an additional $3 million on approval of BELVIQ by the Korean FDA. Ildong is responsible for the development, regulatory approval and ultimately marketing and distribution of BELVIQ in South Korea, including all related costs and expenses.

We will manufacture BELVIQ at our facility in Switzerland, and sell finished product to Ildong for a purchase price starting at 35% of Ildong’s annual net sales. The purchase price will increase on a tiered basis up to 45%, on the portion of annual net sales exceeding $15 million. We also continued to evaluate opportunities to collaborate with companies and other territories, including the EU and we’ll keep you updated as appropriate.

In addition to these efforts, we are focused on continued drug development in a methodical, capital efficient fashion. We recently initiated dosing in a Phase 1 clinical trial of APD811, which is intended for the treatment of pulmonary arterial hypertension to evaluate safety, tolerability, Pharmacogenetics and optimal titration schedule of multiple ascending oral doses of APD811.

Beyond APD811, other prioritized programs include APD334, our S-1 B1 receptor agonist for the treatment of cordial immune diseases, which we expect to evaluate in the Phase 1 clinical trial in the first half of next year and APD371 or CB2 receptor agonist intended for the treatment of pain, which is in the final stages of preclinical development. We look forward to keeping you informed on our progress.

Our upcoming milestones include the U.S. launch of BELVIQ’s in the first quarter of 2013, subject to DEA’s final scheduling designation, decisions in the first half of 2013 from regulatory authorities and the European Union, Switzerland, and Switzerland on our applications for marketing approver of BELVIQ, the potential of additional BELVIQ marketing and supplying agreements as well as collaborations with other drug candidates in our pipeline.

Updates on our development plans to explore a therapeutic potential of BELVIQ results in the first quarter of 2013 from Phase I multiple dose clinical trials of APD811 and the initiation of a Phase I clinical trial APD334 in the first half of 2013. BELVIQ for chronic weight management is the first product resulting from our vision to discover novel medicines that selectively target GPCR.

We are energized every day by the opportunity to develop best-in-class treatments to patients around the world and thank you for your support of these efforts.

We will now open the call to questions. Sayed?

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Cory Kasimov from JPMorgan.

Matt Lowe - JPMorgan

It’s actually Matt Lowe in for Cory today. Just a couple of questions. Firstly, could you provide any insight into the size, scope or duration of the proposed combination of studies?

And then secondly, just to get your view on the reimbursement landscape. How might that be different for BELVIQ versus any of the other obesity drugs? Thank you.

Jack Lief

I’m going to let Craig take that.

Craig Audet

Hi, Matt. In terms of the combination study, we’re in the initial planning stages right now. So we need to discuss this with the FDA before we make any of the details public. We want to make sure that the FDA is aligned with our strategy. So as soon as we do that and we finalize those plans, we will give you more detail.

Jack Lief

And as far as reimbursement is concerned, obviously, as Craig said, in his prepared remarks that still a work in progress, however we believe that Eisai is working hard to get that reimbursement accomplished.

Matt Lowe - JPMorgan

Okay. Thank you.

Jack Lief

Sure.

Operator

Thank you. Our next question comes from Lee Kalowski from Credit Suisse.

Lee Kalowski - Credit Suisse

Thank you for taking my questions. Your partner Eisai, when they reported earnings a few days ago that here’s one competitive advantage might be the availability in the retail setting, I guess compared to the competitors. Obviously, one of the competitors has filed to get in the retail setting. If that changes early next year, does that sort of change the competitive landscape at all?

Jack Lief

Well, keep in mind that we’re focused on providing a new treatment option to the U.S. patients. And with BELVIQ, we have a differentiated drug with the new mechanism and a great marketing partner in Eisai. So we will see how that goes. Craig?

Craig Audet

And Lee, the filing with the FDA from -- is for still a limited retail pharmacy in distribution. So it isn’t opened up to all pharmacies.

Lee Kalowski - Credit Suisse

Okay. Thank for your insight.

Operator

Thank you. Our next question comes from Ted Tenthoff from Piper Jaffray.

Ted Tenthoff - Piper Jaffray

Craig, can you hear me okay?

Craig Audet

Yeah, Ted.

Ted Tenthoff - Piper Jaffray

Hi, thanks for the update. Can you give us an update with respect to some of the progress from competitors and just some of the feedback out of Europe on the regulatory front? Have you guys learned anything that give you any cause or any different strategy in terms of what the European regulators might be looking for or how to approach and kind of handle that agency?

Craig Audet

Hi, Ted. It’s Craig. As you know, the VIVUS issues were more with CNS, birth defects and other -- the cardiovascular effects of their drug. We don’t have those issues. We received our 120-day assessment. Major -- there were three major concerns, very much in line with concerns that the FDA had. As you know, the EMA makes up their own mind, they don’t abide on an FDA decision.

And we saw that with the VIVUS situation. So in our case, they’re going to look at the response we gave them which was very similar to the response we gave to the FDA. But it also included some additional analyses that we did that we provided the FDA after the fact.

So we think that that’s going to really help the EMA to be able to do a proper assessment of our risk benefit. So, you certainly learn from everyone else’s experience and we’re doing that. We have different repertoires. We have different safety and efficacy profile and so we’re making sure we’ll make the best of that.

Ted Tenthoff - Piper Jaffray

Thanks. And when you say different analyses, are you talking both safety and efficacy with respect to submission to the EMA?

Jack Lief

Sure. So, when we -- as you recall, we filed our complete response and then we filed our MAA. And then we started to receive questions from the FDA after the MAA went in. So we did some additional analysis for safety, some additional for efficacy and that helped the FDA, I think, recognize our benefit over risk and profile.

So those safety and efficacy analyses were not included in the original MAA. They were included in our response of the 120-day assessment report.

Ted Tenthoff - Piper Jaffray

Okay. Excellent. That’s really helpful.

Operator

Thank you. Our next question comes from Thomas Wei from Jefferies.

Thomas Wei - Jefferies

Thanks. I just wanted to clarify something that you said about running some safety studies prior to the initiation of the cardiovascular outcomes trial. Can you talk a little bit more specifically about what you’re referring to there? Is that a combination study with phentermine?

Jack Lief

No. I’m sorry it’s -- if something was misunderstood, but the [CVOT] -- cardiovascular outcome study will be done with BELVIQ’s. Craig, do you have any…?

Craig Audet

No. Thomas, do you remember who make those comments, was it Jack or myself?

Thomas Wei - Jefferies

Perhaps, I misheard, it’s -- that’s very possible. In fact, I can follow up with you later about that and go back through the transcript. Maybe just on the question about phentermine combination studies, at what point do you think you’ll have clarity to provide to us on what exactly you’re doing with phentermine?

Craig Audet

Sure. As I previously said, we definitely want to make sure we have these discussions with the FDA before giving a lot of the results. You don’t want to -- a lot of the strategy, we don’t want to tell you what it is and then have to back paddle on that. But what I can tell you is that it is one of our main priorities at this point and so we will be pursuing it aggressively.

Thomas Wei - Jefferies

But does that involve like seeking professional protocol assessments for things or could it be a more sooner timeframe than that?

Jack Lief

Potentially, all the options are on the table right now. We want to make sure that we do it. As Jack said, methodically, so that we’re thinking it through and we have our strategy in place but at the same time we want -- we do see that as a priority for the organization.

Thomas Wei - Jefferies

Okay. And then I’m just curious to get your perspective on how you’re viewing the initial launch of the Qsymia and the implications for BELVIQ, I guess, relative to say maybe whatever you’re thinking is on the size of the overall obesity market opportunity or any other learnings that you think are relevant. It’d be interesting to get your perspective?

Jack Lief

Well, as we said, BELVIQ is a new chemical entity. It’s certainly is a new treatment option. I think the investors view BELVIQ as being relatively safe and well tolerated. And I think that’s going to go a long way to getting BELVIQ a broader distribution in the marketplace, but we’ll have to see how that goes for both Qsymia as well as for BELVIQ. It’s still a bit early to decide.

Thomas Wei - Jefferies

Thanks.

Operator

Thank you. Our next question comes from Steve Byrne from Bank of America.

Steve Byrne - Bank of America

Hey, Craig, I just wanted to drill in a little more on your comment about the 120-day assessment report. Did you say that they have the same issues that the FDA had i.e. coagulopathy, cancer, suicidality, are those issues that were primarily addressed?

Craig Audet

Hi, Steve. The main issues, the main observations that came in the 120 day were the tumors in rats from the two-year carcinogenicity study, the drop on rate in the studies and the coagulopathy question. So, those were the three main, very similar to the questions that the FDA had. As you can imagine they weren’t exactly the same, but very similar.

Steve Byrne - Bank of America

Okay. And then a couple of financials for Robert. When you indicated cash received from Eisai for delivering product, but yet not eligible for the $60 million milestone for delivery of product. How exactly does that work? If you’re delivering product, I thought your payment was not like a cost plus, but rather as a portion of revenue?

Robert Hoffman

Yeah. So, we did deliver the product in advance of the launch for Eisai to be ready for the launch and then have it on the shelf as soon as possible. So -- but I’m not sure what is your question.

Craig Audet

So, the two were independent. So, Eisai has to pay for product as we manufacture and deliver it. And they have to provide us with the payment of the $65 million upon DEA approval and delivery of the launch. So, the two were two independent income streams go -- currently going forward.

So, as Robert said, we’re dependent upon DEA for the $65 million, but for the -- a portion of the launch supply have already been delivered to Eisai and of course we will receive the cash. Now, as Robert will tell you, the revenue recognition will be a different situation, because it’s a sell-through rather than a sell-in strategy.

Robert Hoffman

So that’s full amount that we will receive probably in November, we will invoice in for October, it will be as deferred revenue until we can recognize it.

Steve Byrne - Bank of America

Okay. And so you recognize the revenue only when those -- when that product is actually sold?

Craig Audet

Sold out when Eisai sells it, yeah.

Steve Byrne - Bank of America

Yeah. Okay. All right. That’s helpful. And then your guidance for R&D, Robert implies a meaningful pick up in the fourth quarter, is that the start of this CVOT or what would cause that?

Robert Hoffman

No. It’s really that we kept the guidance the same. It’s going to be on the low end of that range.

Steve Byrne - Bank of America

Okay. And then just lastly, do you have any estimate at this point on how you will allocate the profits that you recognize between the U.S. and Switzerland?

Jack Lief

So, the Swiss subsidiary of Arena GmbH will receive a 100% of the payment from Eisai for manufacturing the product. And the agreement with Eisai as well as Ildong is between Arena GmbH and the collaborator.

Robert Hoffman

But in terms of transfer pricing, we’re still working on that. We’ll have to have that early next year.

Steve Byrne - Bank of America

Okay. All right. Thank you.

Operator

Thank you. Our next question comes from Alan Carr from Needham & Company.

Alan Carr - Needham & Company

Thanks for taking my question. I’m kind of curious about the smoking cessation opportunity. What is involved there and what type of trials are needed then and what’s the mechanism of that?

Craig Audet

Robert?

Robert Hoffman

Sure. We’re interested in smoking cessation based on the mechanism potentially of BELVIQ to operate as the GABA interneuron into the immune systems and that’s this preclinical data suggesting BELVIQ can turn down the dopamine system. And therefore have effects on addiction in that regard.

And there is some data available, preclinical published data in animals on that the ability of the lorcaserin to be effective in these kinds of models. So that’s where the principal interest comes from in terms of the clinical trials, those -- the details around that have to be webbed out, but one could imagine a short-term -- relatively short-term dosing with the follow-up -- a follow up to one year, potentially. But again all of those details need to be webbed out with the FDA.

Alan Carr - Needham & Company

And it acts as a single agent, I take it.

Jack Lief

Yeah. Yeah. Single agent.

Alan Carr - Needham & Company

Okay. And then with the rest of your pipeline you have three compounds it looks like you might move to the clinic next year, is that enough, you plan to continue to push for more next year or you’re just focused on those three?

Jack Lief

Well, keep in mind, we have some earlier stage compounds as well in programs, but those are the most advanced and the nearest term, which will be in the clinic next year. But we’ll keep you posted on the other ones.

Alan Carr - Needham & Company

All right. Thanks very much.

Jack Lief

Sure.

Operator

Thank you. I would now like to hand the conference back over to Ms. Cindy McGee for any closing remarks.

Cindy McGee

Thanks for joining us today and for your continued support. We’re planning to present at a number of upcoming investor conferences and look forward to meeting with many of you in the near future.

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes our program. You may all disconnect. Have a wonderful day.

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