Good day everyone and welcome to Arena Pharmaceuticals’ third quarter 2009 financial results conference call. This call is being recorded. At this time, for opening remarks and introductions, I’d now like to turn the call over to Arena’s Vice President, Finance and Chief Financial Officer, Mr. Robert Hoffman. Mr. Hoffman; please go ahead, sir.
Thank you, Jennifer. Good morning and welcome to Arena Pharmaceuticals third quarter 2009 financial results conference call. I’m Robert Hoffman, Arena’s Vice President of Finance and Chief Financial Officer.
Joining me on the call today are Jack Lief, our President and CEO; and Christy Anderson, our Vice President of Clinical Development. Also available to address your questions are Dominic Behan, our Senior Vice President and Chief Scientific Officer, and Bill Shanahan, our Vice President and Chief Medical Officer.
Before we begin, I’d like to point out that we’ll be making numerous forward-looking statements during this conference call. Such forward-looking statements include statements about internal and partnered programs, financial guidance, strategy and plans, drug development approval and commercialization and other statements that are not historical facts.
Such statements include the words, plan, will, expect or similar words. You’re cautioned not to 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.
Risks and uncertainties that could cause actual results to differ materially from those described in our forward-looking statements include the timing, success, and cost of clinical trials, pre-clinical studies and research activities, the timing outcome of the regulatory process, the timing outcome of our partnership efforts, our ability to obtain additional funds from collaborators and investors, whether our assumptions prove to be correct, and other risks identified in our SEC reports.
For a discussion of these and other factors, please refer to risk factors described in our filings with the Securities and Exchange Commission. The forward-looking we claim the protection of the Private Securities Litigation Reform Act of 1995.
Now, I’d like to turn the call over to our President and CEO, Jack Lief. Jack.
Thanks Robert, good morning. Before Robert covers the financials for the quarter, we will update you on the lorcaserin program, share what we learned at the Obesity Society’s Annual Scientific meeting and discuss the compelling investment opportunity that Arena presents.
Let me begin by telling you that our lorcaserin program remains on track. We presented new Phase III data at the Obesity Society meeting that Christy will speak to. I’m pleased to report at this time we have all of the data in hand that will be included in the new drug application that we are planning to submit to the FDA next month.
Also next month results from the abuse liability study will be presented at the 48 Annual meeting of the American College of Neuropsychopharmacology. BLOOM-DM are one year study evaluating lorcaserin in patients with type two diabetes is ongoing and we expect to announce results in the second half of next year. BLOOM-DM will be filed as a supplement to the lorcaserin MDA.
Also of note, we have recently completed a market research study individually interviewing 50 primary care physicians who are high prescribers of weight loss drugs. Confirming what we have heard previously, physician satisfaction with currently available drugs for weight management is very low. Over half of the physicians interviewed gave one of the lowest possible ratings to current drugs.
Side effects and lack of long term efficacy are the primary reasons for this dissatisfaction, but what is really important about this latest research is that for the first time we shared with doctors the actual Phase III clinical data for lorcaserin and their response was overwhelmingly enthusiastic. Based on multiple detailed descriptions of the efficacy, safety and tolerability data from the BLOOM trial, the great majority of respondents rated their likelihood to prescribe at the highest possible levels.
If lorcaserin is approved, doctors that participated in our market research told us that they would feel confident prescribing lorcaserin to the majority of their overweight and obese patients and predicted substantial levels of use if lorcaserin proves as safe and effective in practice as it did in our pivotal program.
They expect that initially about one quarter of lorcaserin prescriptions will come from switching patients currently taking other obesity medications. More importantly, doctors said about 75% will come from new patients including those who would otherwise not have received a prescription for weight management. If projected market wide, this translates into significant potential lorcaserin revenue from such market expansion.
We are excited about these new data and plan to provide more details on our research findings as we move forward. With pivotal data in hand and a clear commercial opportunity ahead of us, we intend to establish a partnership to help us commercialize lorcaserin. We will provide additional information when it is available.
Christy Anderson, our Vice President of Clinical Development, will now discuss the feedback we received at the recent Obesity Society meeting. Christy.
Thanks, Jack. As Jack mentioned, we recently participated in obesity 2009, the 27 Annual Scientific Session of the Obesity Society. This meeting was an excellent opportunity to present, discuss results from the complete lorcaserin pivotal program with the scientific and medical communities.
The late breaking BLOSSOM data were presented by Dr. Lee Kaplan of the Massachusetts General Hospital and BLOOM data were presented in an oral session by Dr. Steve Smith of Florida Hospital and the Burnham Institute. We presented additional BLOOM data at the pre-conference pharmacology update and in a poster session.
Lorcaserin was also featured in a symposium called spotlight on 5HT-2C, a 90 minute session focused on lorcaserin’s mechanism of action. The new data presented at The Obesity Society meeting expanded on previous data announcements in patients who took lorcaserin, weight loss was associated with improved body composition, cardiovascular risk factors, glycemic parameters and quality of life and was not associated with excess depression or suicidal ideation compared to placebo.
The pivotal Phase III clinical trial program evaluated nearly 7200 patients treated for up to two years and shows that lorcaserin consistently produced significant weight loss with excellent tolerability. The BLOOM and BLOSSOM results were comparable and demonstrated the following effects after one year of treatment according to protocol. About two thirds of patients achieved at least 5% weight loss and over one third achieved at least 10% weight loss. On average, patients lost 17 to 18 pounds or about 8% of their weight.
Secondary end points including body composition, lipids, cardiovascular risk factors and glycemic parameters improved compared to placebo. Heart rate and blood pressure went down an important finding with an obesity drug. Lorcaserin did not increase the rate of cardiac valvulopathy. Lorcaserin improved quality of life and there was no signal for depression or suicidal ideation and importantly, the only adverse event that exceeded placebo rate by 5% was generally mild or moderate transient headaches.
We’ve also performed some post hawk analyses of the data from the individual pivotal studies that demonstrate just how well lorcaserin works. Based on a normal BMI of 25, BLOOM patients lost about one third of their excess body weight and the average weight loss was 35 pounds or 16% of body weight for the top quartile of BLOSSOM patients.
Lorcaserin’s overall profile of medically meaningful efficacy combined with excellent safety and tolerability was received with support and enthusiasm from the physicians in attendance at obesity 2009. Their feedback was helpful and conveyed three clear concise things: First, doctors need new weight management treatments and they want new mechanistic approaches, specifically physicians want drugs with improved with benefit profiles that lead to better, longer term treatment.
Second, safety is of paramount importance in treating overweight or obese patients. Physicians want safe and effective drugs that their patients can tolerate, patients must be able to stay on treatments long enough to reduce their weight and sustain the weight loss. Third, physicians emphasize that weight reduction should translate into improvements in cardiometabolic health. It’s important to see parameters such as blood pressure, cholesterol, triglycerides and heart rate move in the right direction.
At the Obesity Society meeting the heart.org interviewed Dr. Lee Kaplan, who focused on lorcaserin’s success in passing the weight loss and valvular hurdles in the BLOSSOM study. This resulting article was one of that week’s most read stories on this cardiology focused website that provides clinical and other news to the medical community.
Overall, the feedback that we received from our participation in the Obesity Society meeting was very positive and sports our belief that it’s approved the combination of efficacy, safety and tolerability positions lorcaserin at first line therapy for the majority of overweight and obese patients. Jack.
Thanks, Christy. The consistent feedback we’ve received from doctors at obesity 2009 and our market research emphasize the compelling investment opportunity that Arena presents. Lorcaserin has a unique competitive profile and is differentiated from currently approved treatments for weight management and those in development by a number of important characteristics.
Lorcaserin has the right combination of meaningful efficacy with a safety profile that is similar to placebo and avoids increased blood pressure and heart rate, depression, suicidal ideation and cardiac toxicity. Lorcaserin has demonstrated an outstanding tolerability profile reflected by the low incidence of withdrawals due to adverse events.
Lorcaserin’s tolerability profile allows patients to start on the full dose without a titration period. This is important to the real life medical practice, because many primary care physicians don’t have the resources to monitor a titration period for their patients. Two year data support lorcaserin’s long term safety profile and demonstrate maintenance of weight loss in the second year of treatment.
Very importantly, strong global composition of matter patent coverage of a new chemical entity with first expiration in 2023 for this novel single agent and market research shows that lorcaserin has a significant commercial opportunity with physicians who expect to displace currently available agents with lorcaserin as first line therapy and expand the weight management category.
Robert Hoffman will now review our financials.
Thank you, Jack. In the third quarter of 2009, we recorded revenues of approximately $2.6 million compared to third quarter 2008 revenues approximately $1.9 million. In the first nine months of 2009, we recorded revenues approximately $7.7 million compared to first nine months of 2008 revenues of approximately $7.1 million.
Revenues in the first nine months of 2009 included $4.7 million in manufacturing services revenue under our manufacturing services agreement with Siegfried and $3 million for our patent activities with our collaborations with Merck and Ortho-McNeil-Janssen. Research and development expenses continue to decrease significantly over the prior year expenses.
In the third quarter of 2009, research and development expenses were approximately $22.1 million compared to approximately $47.5 million in the third quarter of 2008. This $25.4 million or 53% decrease was primarily attributable to a decrease in clinical study, fees and expenses of approximately $20.2 million due to completing our BLOOM and BLOSSOM trials as we prioritized our spending towards completing activities that support filing in NDA for lorcaserin.
Research and development expenses also decreased significantly in the first nine months of 2009 as compared to 2008. In the first nine months of 2009, research and development expenses were approximately $89 million, compared to approximately $151 million the first nine months of 2008. This $62 million decrease was primarily attributable to a decrease of $51.1 million in external clinical and preclinical study fees and expenses, which was primarily due to completing our BLOOM and BLOSSOM trials.
Research and development expenses in the first nine months of 2009 included, $39.8 million in external clinical fees and expenses, 96% or $38.4 million of which related to lorcaserin. This compares to $90.9 million in external clinical fees and expenses in the first nine months of 2008, of which 85% or $77.5 million related to lorcaserin.
Research and development expenses in the first nine months of 2009 included $2.9 million in non-cash share-based compensation compared to $3.3 million in the first nine months of 2008. Although we expect to continue to incur a substantial research and development expenses in 2009, primarily related to lorcaserin, we expect our total 2009 research and development expenses to be significantly lower than the 2008 level as a large majority of expenses from our BLOOM and BLOSSOM trials from a recognized through the first nine months of 2009.
BLOOM-DM is continuing, but is a much smaller Phase III study than BLOOM or BLOSSOM. In addition, we do not plan to initiate in the near term any other clinical trials. Further contributing to the decrease in 2009, research and development expenses is the workforce reduction of approximately 130 employees that we completed in June.
General and administrative expenses totaled $5.4 million in the third quarter of 2009, compared to $5.9 million in the third quarter of 2008. This $0.5 million decrease was primarily due to decreases in personnel costs and marketing research partially offset by an increase in patent fees.
General administrative expenses totaled $18.7 million in the first nine months of 2009, compared to $21.9 million in the first nine months of 2008. This $3.2 million decrease was primarily due to decreases in salary and personnel cost, including non-cash share-based compensation expense and legal fees primarily patent fees.
General administrative expenses in the first nine months of 2009 included $2.2 million in non-cash share-based compensation compared to $2.8 million in the first nine months of 2008. To the extent our partners reimburse us for patent activities we classify the reimbursements as revenue. Such reimbursements totaled $3 million in the first nine months of 2009 compared to $1.6 million in the first nine months of 2008.
Total non-cash share-based compensation expense was $5.1 million in the first nine months of 2009 compared to $6.1 million in the first nine months of 2008. Net loss allocable to common stockholders decreased significantly to $34.8 million in the third quarter of 2009 compared to $56.2 million in the third quarter of 2008 and $123.4 million in the first nine months of 2009 compared to $177 million in the first nine months of 2008.
Cash, cash equivalents and short term investments totaled $143.5 million at September 30, 2009 and reflect net proceeds received in July 2009 of approximately $95.6 million from $100 million loan secured from Deerfield in net proceeds we received in July of approximately $49.7 million from a public offering of 12.5 million shares of our common stock at $4.17 per share.
As a result of the closing of this offering, we were required to repay Deerfield $10 million that was scheduled to be repaid in July 2010. We accounted for the Deerfield transactions in accordance with generally accepted accounting principles which required us to separately value four components of the transaction on the closing date of the transaction. The $100 million loan was initially valued at $47.9 million on a relative fair value basis and is recorded as a long term liability on the balance sheet.
The discount will be amortized over the life of the loan. The recorded balance on the balance sheet at September 30, 2009 was $43.9 million. This compares to the outstanding principal at September 30, 2009 of $90 million. The 28 million warrants that have issuance costs were valued at $39 million on a relative fair value basis. The fair value of the warrants is recorded as additional paid in capital on the balance sheet, because these warrants are eligible for equity cap classification, no adjustments to the recorded value will be made on an ongoing basis.
Deerfield’s right to loan us up to additional $20 million under similar terms as the original loan including the $5.6 million contingently issue of warrants was valued at $9.5 million. We have classified this instrument as a long term liability on the balance sheet and accordingly will be revalued on each subsequent balance sheet date until it is exercised or expires. With any changes in the fair value between reporting periods recorded in interest or other income and expense line item.
Deerfield’s ability to accelerate principal payments in certain circumstances under the loan was valued at $.5 million. This acceleration right is classified as a long term liability on the condensed consolidated balance sheet and accordingly will be revalued on each subsequent balance sheet date until it is exercised or expires.
With any changes in fair value being recorded in the interest and other income and expense line item, as a result of this transaction, we expect our interest expense line item, which will include cash and non-cash interest expense related to Deerfield transaction to be significant over the term of the loan.
We continue to follow a conservative investment policy that is focused on principal preservation and we do not invest our cash in collateralized debt obligations, auction rate securities or equity securities. At September 30, 2009 we had 92.7 million shares of common stock outstanding.
Our financial guidance for all of 2009 continues to be $9 million to $11 million in revenues which includes revenue from our manufacturing facility in Switzerland and excludes any potential milestones from existing collaborations in revenue from any new collaboration in 2009.
Internal research and development expenses to total approximately $62 million to $66 million, including non-cash expenses, which total approximately $12 million, this compares to 2008 internal research and development expenses, which total $80.9 million of which $11.4 million was non-cash. External clinical and preclinical expenses to be approximately $42 million to $46 million with over 95% related to lorcaserin this compares to actual 2008 external clinical and preclinical expenses $123.5 million.
General, administrative expenses total approximately $24 million to $26 million including non-cash expenses totaling approximately $3 million. This compares to 2008 general, administrative expenses of $30.5 million of which $4.4 million was non-cash. $5million in capital expenses, primarily for equipment related to manufacturing of Lorcaserin. We expect to end 2009 with approximately $120 million to $130 million in cash, cash equivalence and short term investments, which assumes no new collaborations, milestone achievements or financing including selling real estate that we currently own.
I’ll now turn the call back to Jack.
Thanks, Robert. In addition to lorcaserin and our internal programs, our partner programs with Merck and Ortho-McNeil-Janssen continue to progress. Ortho-McNeil continues to evaluate multiple doses of APD597, an oral drug candidate that we discovered for the treatment of type 2 diabetes. The niacin receptor agonist for atherosclerosis and related conditions, which is partnered with Merck, is currently being evaluated in a Phase II program. We will provide additional information and results from these trials as soon as we are able to.
The future of Healthcare relies on the delivery of innovative, novel treatments designed selectively to maximize their intended effect and avoid safety and tolerability issues. We’re focused on submitting a comprehensive NDA package and working with the FDA during the review process while preparing for the launch of commercialization of lorcaserin.
Physician feedback supports the potential of lorcaserin to change the way primary care physicians treat the broad population of their overweight and obese patients. We look forward to the opportunity to provide patients and physicians with lorcaserin, reenergize the weight management category, advance human health through innovative science and build significant value for you, our shareholders.
Thank you. The call is now open to questions. Jennifer.
(Operator Instructions) Your first question comes from Craig Gordon - Cohen & Co.
Craig Gordon - Cohen & Co.
A couple questions, in the NDA Submission, do you guys plan on submitting proposals both for Phase IV commitments as well as a REMS program?
We specifically discussed this issue with the FDA at our pre-NDA meeting and this will be a review issue, but at the present time we don’t see a safety signal to pursue, so we are going to continue to down evaluate our data filed with the NDA and then have discussions with the FDA after that.
Craig Gordon - Cohen & Co.
In terms of a partnership, I guess in the past there’s been a discussion that perhaps it could come, I guess, year end this year or perhaps the first half of 2010. Is that still a realistic time line or is it more likely to come perhaps after the FDA panel or approval?
Well, partnering is an important goal for Arena. We’re working hard on this and when we have something to announce, we will. We believe lorcaserin’s unique profile allows it to be first line therapy and so therefore, it’s very attractive to partners and obviously we can’t comment on who we’re talking to or anything like that, but when we do have something to announce, we definitely will.
Your next question comes from Terence Flynn - Lazard Capital Markets.
Terence Flynn - Lazard Capital Markets
The first question, just in terms of the market research you guys recently conducted. Did you ask any questions specifically about combination use of lorcaserin with phentermine?
No we did not.
Terence Flynn - Lazard Capital Markets
Just a follow-up on the partnership discussions, I was wondering you guys have guided to, you’d like to provide drug substance to your partner and take a royalty. In the event that let’s say, you can’t get terms, which you view as favorable, would you consider launching lorcaserin with a specialty sales force?
As we said, we intend to partner, but we do have contingency plans in place, should we not reach a proper agreement and if we need to execute our commercialization plans, I don’t expect a delayed launch for lorcaserin. So yes, we do have such contingency plans in place.
Terence Flynn - Lazard Capital Markets
What type of sales force or what size sales force, I guess do those contingency plans assume?
I prefer not to comment on the size of the sales force. Obviously, you can make your own conclusions. This is a primary care market and we’re looking for a very robust partnering opportunity here.
Your next question comes from Jon Lecroy - Hapoalim.
Jon Lecroy - Hapoalim
Can you tell me your current cash position, how far into 2010 that will take you?
We haven’t given 2010 cash guidance, but characteristically you can see that our internal research and development expenses have decreased significantly, I believe in the third quarter it was about $14 million. So if you model that out and then G&A has gone down significantly as well and in terms of external expenses you can see that with the BLOOM and BLOSSOM study over the spend for the quarter about $7.7 million and is even less than that in the fourth quarter. So if you kind of model that out, you can see that we’re well financed at this time.
We’re going to end the year with at least $120 million. So you can do your subtraction.
Jon Lecroy - Hapoalim
Then are you still planning on filing the MDA kind of year end this year or early next year?
That’s next month, this year.
Your next question comes from Alan Carr - Needham & Co.
Alan Carr - Needham & Co.
I want to talk a bit about partnering. Can you comment on in your discussions with potential partners relative importance of other end points like in diabetes, that sort of thing and also if you can elaborate a bit on a previous question? Tell us a bit more about timing for contingency plans on building your own sales force? At what point would you start to work on that?
Partners look at these things holistically as we do and as do physicians and we don’t have a diabetes treatment per se. We have a weight management treatment. As Christy said, as weight decreases, all of these other secondary parameters such as blood pressure, cholesterol, risk for diabetes, all decline, so I think that’s a good thing.
In terms of timing, we said that this is an important goal for us partnering lorcaserin and certainly we expect to partner between now and sometime in the middle of next year. So we do have contingency plans if we don’t get there at that point in time. So we’ll just have to wait and see how that goes.
Alan Carr - Needham & Co.
I missed Robert’s guidance on SG&A for the year. Could you say that again?
Yes, it was $24 million to $26 million.
Your next question comes from Jason Zhang - BMO Capital Markets.
Jason Zhang - BMO Capital Markets
I have a question about partnership too. Your neighbor Amylin, recently signed a deal with, I guess, Takeda for $75 million up front and up to $1 billion milestone payment for injectable that only has passed Phase II and I guess at the same time there are three other obesity drugs close to marketing and nobody seems to sign deals, but ones that has passed Phase III.
So I’m wondering from your talk with pharmaceutical company, what are they looking at? Why are not anyone who is interest in this field and signing up any of the drugs that could be on the market at any times now? Is it surprised that people not asking that is too high or something else that we may not know?
I can’t really comment on Takeda‘s or Amylin’s thought processes in the partnership. What I can tell you is that the deal valid dates the attractiveness of this weight management market and it is consistent with the theme that doctors need new tools as Christy said in obesity 2009. We are excited that lorcaserin can provide such a new tool for physicians and their patients that, does not currently exist. So I can’t really comment further on our discussions going on right now.
Your next question comes from Jeff Elliott - UBS.
Jeff Elliott - UBS
I just had a little question on the market research. When you do that, what sort of assumptions do you give the doctor in terms of pricing and reimbursement, because that was obviously a big theme at obesity this year?
We haven’t done a pricing study per se yet specifically with our profile, but we plan to price very, very competitively. So it’s not going to be a terribly expensive drug and we did provide physicians with the profile, the actual profile from the pivotal studies of lorcaserin. So doctors could see exactly, what the drug did and how tolerable it was. So we think this is a very well validated instrument for us to rely on.
Jeff Elliott - UBS
I guess I’m just wondering, do you then assume that the doctors assume that there will be full reimbursement in the whole population or is that just left up to them and just answer the questions that are presented to them?
Reimbursement is always a moving target. I think the reason that reimbursement is not well understood for obesity drugs is that there really are no good drugs out there that can address what doctors’ need, which is something that can provide safe and effective weight management over a long period of time for their patients, is easy to take and that sort of thing. So I think with this right balance of efficacy and safety, we have a better chance for reimbursement than has been possible before.
Your final question comes from Carol Werther - Summer Street Research.
Carol Werther - Summer Street Research
I was wondering if you have any update on the timing of publishing the BLOOM and or BLOSSOM results.
We currently have the BLOOM data in review in a major journal and will be submitting the BLOSSOM data shortly after the NDA work has been completed.
Carol Werther - Summer Street Research
Also I just wondered where you are on partnerships on any of your earlier program.
We are talking with companies about partnering some of our other programs in areas such as diabetes and alertness and inflammation, but I can’t really comment on that either right now because these things are uncertain and the timing is variable. So you just have to be patient.
That does conclude our question-and-answer session for this day. At this time, I would like to turn the conference over to Mr. Jack Lief for any additional or closing remarks.
Okay. Thank you. So before finishing, I’d like to reiterate that we remain focused on benefiting patients and building long term stockholder values through the discovery, development and commercialization of Arena drug candidates independently and with our partners. Our corporate values, integrity, innovation, team work and excellence remain at the core of all that we do. Thanks again for joining us on the call today.
Thank you. That does conclude today’s teleconference. We thank you all for your participation.
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