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Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX)

Q2 2008 Earnings Call Transcript

August 7, 2008 4:30 pm ET

Executives

Rob Whetstone – IR

David Hale – Executive Chairman and Interim CEO

Richard Pascoe – President and CEO

Meg McGilley – VP and CFO

Jeff Raser – SVP of Sales and Marketing

Analysts

Ken Trbovich – RBC Capital Markets

Jason Napodano – Zacks

Tim Ackerman – SAI

Operator

Good afternoon, ladies and gentlemen, thank you for standing by. Welcome to the Somaxon Pharmaceuticals second quarter 2008 financial results conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be open for questions. (Operator instructions) This conference is being recorded today, Thursday, August 7, 2008. At this time, I like to turn the conference over to Rob Whetstone, Investor Relations for Somaxon Pharmaceuticals. Please go ahead, sir.

Rob Whetstone

Thank you. Good afternoon, everyone, and thank you for joining us today to discuss Somaxon Pharmaceuticals' 2008 second quarter financial results. On the call today are David Hale, Somaxon's Executive Chairman and Interim Chief Executive Officer; Meg McGilley, the company's Vice President and Chief Financial Officer; Jeff Raser, the company's Senior Vice President Sales and Marketing, and Richard Pascoe, the company’s respected President and Chief Executive Officer.

First some housekeeping issues before we start, earlier this afternoon Somaxon released financial results for the 2008 second quarter. If you have not received this news release or you'd like to be added to Somaxon's fax and e-mail list to receive company information, or if you would like to change your contact information, please contact Janet Simmons at PondelWilkinson at 310-279-5974. We encourage everyone to read today's news release as well as Somaxon's quarterly report on Form 10-Q that will be filed tomorrow.

In addition, be advised that this conference call is being broadcast live on the Internet at the investors.somaxon.com/eventdetail.cfm. A playback of this call will be available and may be accessed at that site. Please note that certain of the information discussed in the call today is covered under the Safe Harbor Provisions of the Private Securities Litigation Reform Act. I caution listeners that during this call Somaxon management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Somaxon's press releases and SEC filings including the Annual Report on Form 10-K and quarterly reports on Form 10-Q.

The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 7, 2008. Somaxon undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that said, let me turn the call over to David Hale. David?

David Hale

Thank you, Rob, and good afternoon everyone. We appreciate you joining us to discuss our second quarter 2008 financial results and our plans and outlook for the remainder of 2008.

We accomplished a number of important corporate objectives since the beginning of the second quarter of 2008. This morning we announced that Richard Pascoe will become our President and Chief Executive Officer and a member of our Board of Directors on Monday, August 11, 2008. Rich brings to the company proven leadership skills and significant experience relating to the commercialization of pharmaceutical products and the establishment and management of corporate alliances. Rich was most recently Senior Vice President and Chief Commercial Officer at ARIAD pharmaceuticals. Prior to ARIAD Rich had significant experience in the commercialization of CNS drugs as Senior Vice President of neuroscience at King Pharmaceuticals and in various sales and marketing positions at King, Medco, and COR Therapeutics. At King, he also had experience in the insomnia market. I would like now to invite Rich to say a few words.

Richard Pascoe

Thank you, David. I am very pleased to join Somaxon at this important time as the company prepares for a potential commercial launch of SILENOR in early 2009. First I want to start by commending the entire organization for their remarkable job that has be done today to position both Somaxon and SILENOR for success in the market place. Because of SILENOR clinical profile differentiation from its currently available insomnia treatment, I believe that it could have significant advantages in a large and growing market if it is approved by the FDA.

I look forward to working with the Somaxon management team and Board of Directors in seeking to enhance stockholder values through the potential launch of SILENOR and the growth of a sustainable, commercial pharmaceutical business. David.

David Hale

Thank you, Rich, and welcome.

Richard Pascoe

Thank you.

David Hale

In connection with Rich’s commencement of employment I will relinquish my role as Interim Chief Executive Officer but will continue to serve as the company’s Executive Chairman of the Board.

Somaxon accomplished a number of objectives during the second quarter. In May we announced 2 financing transactions. We entered into a $15 million secured loan agreement with Oxford Finance Corporation and Silicon Valley Bank as well as a committed equity financing facility with Kingsbridge Capital Limited in which Kingsbridge has committed subject to certain conditions to provide up to $50 million of capital to the purchase of newly issued shares of our common stock. In addition in April we received the results of a large consumer market study, which we conducted to study and survey more than 1750 people who were either current or recent users of prescription insomnia products. We are encouraged by the results of this study, which show that there is significant dissatisfaction with currently available insomnia treatments and indicated that almost 90% of the respondents have a favorable view of the clinical profile of SILENOR. We continue to conduct additional market research activities some of which Jeff will describe later in the call.

During the quarter we also presented data from our Phase III clinical trial programs for SILENOR for the treatment of insomnia at the annual meetings of the American Psychiatric Association and the Association of Professional Sleep Societies each of which occurred during the second quarter of 2008. Four posters relating to our SILENOR clinical development program were presented at each of these meetings and at the APSS meeting there was an additional oral presentation relating to our clinical data by Dr. Tom Roth, the Chief and Division Head at the Sleep Disorders and Research Center at Henry Ford Hospital and one of the world’s foremost authorities in sleep disorders including insomnia and the development of therapies to treat these disorders. Also at the APSS meeting, we supported a continuing medical education symposium entitled, Taking a Different Pathway

The Scientific Basis for the Unique Effects of Selective Antihistamines in the Treatment of Insomnia. During the remainder of 2008 we will continue to focus on the regulatory approval process for our NDA for SILENOR and planning for the commercialization of SILENOR if it is approved by the FDA.

I will talk more about our SILENOR program and plans after Meg reviews our financial results.

Meg McGilley

Thanks, David, and good afternoon everyone. Net loss for the second quarter of 2008 was $10.4 million, or $0.57 per share compared with $6.0 million, or $0.33 per share for the second quarter of '07. As a development-stage company, Somaxon had no revenues in the second quarter of 2008.

Research and development expenses were $5.8 million for the second quarter of '08 compared to R&D expenses in the second quarter of 2007 of $3.0 million. The increase is primarily due to the commencement during the second quarter of 2008 of the standard clinical trial that we decided to voluntarily undertake to evaluate the potential for electrocardiogram or ECG effects of doxepin, the active ingredient in SILENOR.

Marketing, general and administrative expenses for the second quarter of 2008 were $4.6 million versus $3.5 million in the 2007 second quarter. The increase was primarily due to higher marketing, personnel, and general costs as a result of increased activities to prepare for the potential commercialization of SILENOR. This was partially offset by lower share-based compensation expense allocable to marketing, general, and administrative personal due to divesting of certain higher value stock options during or prior to the second quarter of ’08.

Included in these results is non-cash, share-based compensation expense recognized in accordance with FAS 123R of $1.5 million for the second quarter of 2008 compared to $1.9 million in the second quarter of 2007. As of June 30, 2008, we had 18.4 million shares outstanding and 23.0 million fully diluted shares, which includes outstanding stock options and warrants.

At June 30, 2008, we had $31.8 million in cash, cash equivalents and marketable securities and current and long-term debt of $14.1 million. Under the loan arrangement with Oxford Finance Corporation and Silicon Valley Bank we are required to maintain a minimum cash balance at Silicon Valley Bank of at least 50% of average – of the aggregate amount outstanding under the loan. This minimum cash balance of $7.5 million at June 30, 2008, is included in restricted cash on our balance sheet. We believe based on our current operating plan that our cash, cash equivalents and marketable securities together with additional funds available under the Kingsbridge equity line will be sufficient to fund our operations through at least the first quarter of 2009.

With that brief financial review, I'd like to turn the call back over to David to take us through our SILENOR program and related matters. David?

David Hale

Thanks, Meg. We continue to be exited about the potential FDA approval of SILENOR for the treatment of insomnia and to commercialize this product candidate. The FDA’s review of the NDA is ongoing and pursuant to PDUFA guidelines we expect the FDA to complete its review and provide an action letter to us by December 1, 2008. We believe that the efficacy and safety profile demonstrated in our clinical program is sufficient to support a determination by the FDA that SILENOR can be approved for the treatment for insomnia. With respect to our commercialization preparation, we continue to pursue discussions with third parties relating to the commercialization of SILENOR. The outcome of this process and the structure of any resulting transaction can vary depending on the interest and objectives of the party.

Our objective and preference is to enter into a strategic collaboration that would allow us to copromote SILENOR to specialists. In the event that we do not enter into such a transaction, we intend to develop a commercial organization and a marketing strategy that will allow us to focus on specialists in high prescribing positions ourselves. We are currently conducing market preparation activities to prepare for the launch of SILENOR which include extensive qualitative and quantitative market research to evaluate the reaction of physicians, consumers, and third party payers to the product profile of SILENOR, the positioning of SILENOR, and identifying the physicians and patients that we will be targeted testing various potential key messages, evaluating various traditional and nontraditional methods to achieve our desired reach and frequency and raising of awareness of SILENOR through dissemination of clinical and nonclinical data, semi-sponsorship and interaction with key opinion leaders in the insomnia field.

In addition, we are taking steps to ensure that we have the relationships and systems we need relating to manufacturing, supply, packaging, distribution, pricing and reimbursement. Previously we have entered into a manufacturing services agreement with Patheon Pharmaceuticals to manufacture our commercial supplies of SILENOR. We are working closely with Patheon to develop and scale up the commercial manufacturing process for SILENOR and we will continue to collaborate with Patheon to validate this process and to produce commercial supplies of SILENOR if it is approved at the FDA.

We have also recently entered into agreements with Plantex USA to manufacture our supply of doxepin active pharmaceutical ingredient and with Anderson Packaging to package SILENOR finished products, and we have another agreement in place for the supply of the primary excipient contained in SILENOR.

We are also in discussions with third party logistics companies to help us with storage, distribution, and related services. In addition, we have continued to undertake a number of activities designed to prepare us for FDA interactions regarding the NDA. This work is intended to minimize potential risk and delays associated with the NDA review process and to support our proposed labeling for SILENOR. These activities can range from preparing additional analysis of our data to conforming with experts regarding aspects of our NDA, our proposed labeling to conducting additional study.

As Meg mentioned earlier, we have voluntarily decided to undertake a standard clinical trial of doxepin designed to evaluate the potential for ECG effects. As we have stated, it is important to note that we are not conducting this clinical study due to observations from our clinical program and the FDA has not requested us to conduct this study or indicated to us that it maybe required for regulatory approval. Instead, based on consultation with our regulatory and clinical experts and in consideration of the evolving regulatory environment we believe that it is prudent to conduct a study to have the data should it be requested by the FDA. We have completed patient enrollment in this study and we expect that the data from this study will be available in the fourth quarter of 2008.

Our goal of undertaking all of these activities and others that are underway or planned is to allow us to capitalize on the attributes that we believe could lead to the commercial success of SILENOR if it is approved by the FDA. Many of these attributes are merged from the extensive clinical trial program for SILENOR that was the basis of our NDA submission. And as we have reported on several occasions all of the clinical trials demonstrated statistically significant differences relative to placebo on their primary endpoints and multiple secondary endpoints of efficacy for the treatment of insomnia.

One and very important aspect of our clinical development program was the demonstration of a favorable safety and tolerability profile for SILENOR with the overall incidence of adverse events comparable to placebo, a low discontinuation rate, and no evidence of dependency, withdrawal, tolerance amnesia, or complex sleep behaviors.

In addition, the FDA has indicated to us that it will recommend that SILENOR not be scheduled as a controlled substance, which we believe can lead to a competitive advantage for SILENOR for a number or reasons. Specifically, if would allow us to provide direct sampling of SILENOR to healthcare providers which we believe could facilitate ease of patient trial and usage. It could alleviate physician and patient concerns relating to abuse and dependency, and we believe that it could lead to favorable formulary positioning for SILENOR.

Our confidence in the potential of SILENOR in the insomnia market derives from our clinical and nonclinical data as well as the market research that we have conducted with physicians, patients, and third party payers.

Jeff Raser will now review some of our most recent commercial preparation work and market research with you.

Jeff Raser

Thanks, David, and good afternoon everyone. As David mentioned, in the second quarter we continued to progress our pre-launch market preparation and planning activities relating to the strategies and tactics associated with the potential launch of SILENOR in early 2009 if the product is approved by the FDA. As the market dynamics in the insomnia segment continue to evolve our enthusiasm for the potential of SILENOR remain strong. We continue to see favorable trends in prescription volume that we believe can be accelerated with the introduction of a differentiated product for the treatment of insomnia. The market remains under-diagnosed and undertreated. According to the APA, approximately one-third of American adults or 70 million people are affected by insomnia. Today we believe that only about 20% of those who suffer from insomnia are currently treated with prescription medications, suggesting a large, unmet clinical need.

We believe there are a number of factors that contribute to this including the lack of widespread understanding of the connection between health-related issues and chronic insufficient sleep. These include mood disturbances, difficulties with concentration and memory, and certain cardiovascular, pulmonary or gastrointestinal disorders.

Chronic sleep deprivation has also been associated with an increased risk of depression, diabetes and obesity, among other disorders. As people who suffer from insomnia and the clinicians who treat them continue to learn more about the important connection between sleep and health, we believe it will be a catalyst for future market growth.

Another major factor relates to the concerns that people have – that people with insomnia have relating to the use of many of the currently available prescription treatment options. In the second quarter we conducted a large consumer research study of more than 1750 people who are either current users of insomnia medications or had been within the past year. During the next few minutes, I would like to review some of those results. Less than one-third of current users described themselves as very satisfied with their current treatment, whether due to concerns about efficacy or side effects and tolerability and safety. On the efficacy side, the respondents cited a lack of a full night’s sleep as the single largest factor for their dissatisfaction.

Over 65% of the respondents cited risk of dependence or addiction as a concern that led them to discontinue their medications or limit its use. This was the most frequently mentioned concern.

The respondents were also worried about next day grogginess and central nervous system related side effects attributed to many of the currently prescribed products such as memory impairment, hallucination and undesired unconscious actions, and complex sleep behaviors.

Most importantly, when presented with the product profile of SILENOR, almost 90% of consumers rated it favorably, and over 70% said they would discuss this product option at their next doctor visit.

All of this suggest that there is room for significant growth in the prescription market with the introduction of a differentiated product like SILENOR that has the potential to deliver the efficacy consumers want – defined as seven to eight hours of sleep, without next-day grogginess, memory impairment, or other side effects, and without the risk of dependency.

We have also recently concluded a thorough market research initiative in which we surveyed third party payers about the insomnia market and SILENOR’s potential place in this market. We are encouraged by the results of this market research and believe that these results show that SILENOR has the potential to be favorably received by the payer segment. This is largely due to the significant differentiation of SILENOR from currently available treatment options in terms of its mechanism of action, its clinical efficacy and safety and tolerability profile in both adults and the elderly and importantly the fact that the FDA has indicated that it will not recommend that SILENOR be a schedule 4 controlled substance.

As a result, we believe that SILENOR has the potential to secure favorable formulary status consistent with other branded and promoted products. Despite the positive results of this market research, we are also evaluating strategies, various alternatives to reduce the impact that any third party reimbursement challenges could have on patient trial and usage. In addition, we are pleased with the results of our educational initiatives that have included the presentation of relevant data from our SILENOR Phase III clinical development program at this year’s APA and APSS annual meetings.

We will continue to share data from our development program for SILENOR at Congresses and scientific meetings throughout the year. Importantly, we have supported and will continue to support grant requests for CME programs that will foster ongoing physician education on important issues relating to the treatment of insomnia.

With that, let me turn the call back over to David for some closing remarks.

David Hale

Thank you, Jeff. As Jeff indicated, differentiated clinical profile of SILENOR, which was demonstrated in our clinical program has resonated very well with physicians and consumers in our market research. Our market research also leads us to believe that reasonable formulary replacement and reimbursement for SILENOR is achievable. These findings underlie our belief in the potential for success in the insomnia market if SILENOR is approved by the FDA. We also believe that the insomnia market itself continues to represent a significant, long-term growth opportunity. The majority of the 70 million Americans who have ongoing symptoms of insomnia continue to go untreated, while a substantial portion of those who use prescription medicines continue to express dissatisfaction, especially with respect to sleep maintenance, early awakenings, side effects, and fear of dependence.

We believe that growth in the market can be sustained and potentially accelerated if new differentiated products like SILENOR are introduced. In fact based on our review of the insomnia market we believe that SILENOR has the potential to be the first new compound approved for the treatment of insomnia since 2006. Obviously, a significant focus of our activities in 2008 will be to work with the FDA to obtain approval to market SILENOR and to continue to market preparation activities we described earlier. We are also actively evaluating products and product candidates that could add to our pipeline that we believe would enhance long-term shareholder value.

With that and the available time, we would like to address any questions that you may have. Operator?

Question-and-Answer Session

Operator

(Operator instructions) The first question is from the line of Ken Trbovich with RBC Capital Markets. Please go ahead.

Ken Trbovich – RBC Capital Markets

Thanks for taking the question. I guess I want to circle back to the study you started in April. I know you are saying that will be in the fourth quarter, but it sounds as though you don’t have plans to submit the data to the agency and I guess, I am just trying to understand the rationale for that?

David Hale

Well, we decided Ken to voluntarily undertake this – the standard clinical trial of doxepin to evaluate the potential for electrocardiogram or ECG effect. We were not required to undertake this study by the FDA, or it was not the result of any observation seen in our clinical program. So, our plan is to have the data available in the fourth quarter should the FDA request the data.

Ken Trbovich – RBC Capital Markets

Okay, but I am assuming this is a standard QT prolongation study.

David Hale

Yes, it is.

Ken Trbovich – RBC Capital Markets

Okay, and I guess what I am curious about if it is being done under the IND and they are aware of the fact that you are doing this study, why wouldn’t they want to see the data?

David Hale

Ken, they may very well want to see the data and so our plan is to have the data available should they request it. All I am saying is that as of today they have not requested the data, that the study be conducted or that the data be available for review prior to the PDUFA date.

Ken Trbovich – RBC Capital Markets

Okay, and in the study are you contemplating or does the study include doses that are higher than those that you intend to commercialize in an effort to try to (inaudible) out whether there is a cut point at which the QT prolongation might occur and below which it might not.

David Hale

Yes, and this study design we did include a dose of doxepin that was substantially above the dose of doxepin that would be in the highest dose we would plan to market for SILENOR.

Ken Trbovich – RBC Capital Markets

Okay, and then once the study is completed, are you going to communicate those results in any way shape or form in subsequent literature, you expect them – I mean obviously I am assuming if there is no signal, there is no reason to include it in the labeling, but it would seem if there were a signal you would have to include that it in the labeling.

David Hale

I think you are right Ken.

Ken Trbovich – RBC Capital Markets

Okay, and just final question in terms of line extensions, I know obviously you guys are working through formulation. I think it has been mentioned before possibly starting to do some studies in that area. Are those going to be just simple PK [ph] studies or what is the nature of the studies as you progress on formulation work?

David Hale

I think that we have indicated that are working on a second generation SILENOR product. We are currently doing work on the formulation and initially those studies would be PK studies. And then based on the results of those we would determine what other studies would be required, what benefit clinically and from a patient standpoint that could be observed with those studies and then make the decision whether to move ahead to conduct clinical trials on those formulations.

Ken Trbovich – RBC Capital Markets

So are those things that you might be able to do later this year or these things that really come into play as we look out to ’09 and 2010?

David Hale

I think that if we decide to move ahead that some of the data would start to be available in 2009 and 2010 on the PK activity and the clinical studies would depending again on what kind of clinical studies we determine would be required for approval, would start to occur during that time frame.

Ken Trbovich – RBC Capital Markets

Okay, thank you.

David Hale

Thanks Ken.

Operator

(Operator instructions) The next question is from the line of Jason Napodano with Zacks. Please go ahead.

Jason Napodano – Zacks

Hi, guys. Thanks for taking the question.

David Hale

Hello Jason.

Jason Napodano – Zacks

I am just wondering in your market research here if you have given thought the size of the sales force that would be necessary for full promotion of the product or the size of the sales force that would be necessary if you do have a deal in hand and you get to keep some copromotional rights?

David Hale

Yes, obviously we have done a significant amount of valuation of the market dynamics related to the size of the sales organization required to market SILENOR in this market. And those dynamics relate to first of all the fact that over 50% of the prescriptions are written by approximately 40,000 physicians and of those the top (inaudible) a significant number of those are specialists. So in looking at the requirement for marketing SILENOR that would have an effect on both the specialist and the high prescribing physicians, we think that total number of sales reps is around the 500 mark. Obviously, you could target specialist with a smaller number of sales reps, but obviously that would affect the overall market potential for the product. Jeff, do you want to comment.

Jeff Raser

Yes, I think David is exactly right. Thank you David. The other interesting thing that you have to note in this market place is kind of the changing competitive dynamic as well. As we enter the market hopefully in the early 2009 time frame the competitive landscape we see is changing. If you look at all the hard measures of promotional spend, whether it is office-based contacts, samples, direct to consumer advertising, other promotional vehicles, the trend lines by the competitors in the market are down. And so we see an opportunity to enter that market place with a less crowded share of voice perspective. So, we find the dynamic pretty favorable.

Jason Napodano – Zacks

Okay, and I appreciate that. Do you think that or do you anticipate looking at bringing on not necessarily a sales force but at least some a director or some managers before the action date?

David Hale

Yes, the answer is yes. We recently hired Joe Merkert as Vice President of sales and operation, a person who has significant experience in that area both in sales operations and managed care and we will be bringing on some additional people in sales and marketing to work with Jeff in the market preparation activities. We do not plan even in a copromotion scenario, we do not plan to bring on sales representatives prior to approval by the FDA.

Jason Napodano – Zacks

Okay, one further question guys. In looking at the study, looking at your discussions with potential partners, are you doing things like securing manufacturing agreements and securing packaging and distribution, potentially distribution agreements, does that – I guess how do I ask this question, do your partners look at that kind of negatively because they would be interested in controlling the distribution and the packaging or is there any benefit to that in the eyes of a partner?

David Hale

Well, I think that most companies in the pharmaceutical industry have made the determination that manufacturing is not a basis of competition especially with small molecules. So, most of them have – do not have an issue with other companies having again assuming that those other companies have the capability, have appropriate GMP, in terms of manufacturing the product. But also it is very important to understand that in order to meet our commercial timeline for introduction that we need to move ahead with manufacturing the validation lots and so on so that we don’t lose any time and that is very important too in our discussions with potential partners is the timing of the ability to launch SILENOR in the market.

Jason Napodano – Zacks

Very good, I appreciate the answers. Thank you.

Operator

Thank you, Our next question comes from the line of Tim Ackerman with SAI. Please go ahead.

Tim Ackerman – SAI

Hi, I just have one question for you. Should the FDA request your information from the QT study, given that it wasn’t part of the filing would they deem the filing incomplete?

David Hale

I think that the answer to that is that basically according to the PDUFA guidelines the FDA accepted our file, our NDA file on March 31st, and basically in accepting the file they deem the file to meet a certain threshold of requirements for review. So, we do not think they would consider the file to be incomplete because they have never requested that data be available.

Tim Ackerman – SAI

Okay, very good. Thank you.

Operator

Thank you and at this time, there are no additional questions. I would like to turn it back to Mr. David Hale for any closing remarks.

David Hale

Thank you all for joining us this afternoon. We appreciate your continued interest and support. We are continuing to make progress we believe with SILENOR and believe that we are on track to receive an action letter by the PDUFA date. If you have further questions, please do not hesitate to contact our corporate or investor relations team at Somaxon. That concludes our call today and thanks for your attention.

Operator

Thank you, ladies and gentleman. That does conclude our conference for today. If you would like to listen to the replay of today’s conference please dial 1-800-405-2236 or 303-590-3000 using the access code of 11118108 followed by the pound key. AT&T would like to thank you for your participation. You may now disconnect.

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