Mar 6, 2008
Executives
Ina Cu - IR Carl Pelzel - President and CEO Tammy Cameron - Controller and Principal Accounting and Financial Officer
Analysts
John Gordon - Deltec Asset Management Andy Schopick - Nutmeg Securities
Operator
Welcome to the Depomed yearend 2007 conference call. (Operator Instructions) At this time, I would like to turn the conference over to Ina Cu with Investor Relations.
Please go ahead.
Ina Cu
Good afternoon. This is Ina Cu, and with me today are Carl Pelzel, President and Chief Executive Officer and Tammy Cameron, our Controller and Principal Accounting and Financial Officer.
At the close of market today, we issued our preliminary financial results for the year ended December 31, 2007. The purpose of this call is to expand on the contents of our press release and to provide financial guidance for 2008.
Before we begin, I would like to remind you that during this call we will be making forward-looking statements related to various aspects of our business, including clinical development time lines, financial matters, and commercialization of our marketed products. Actual results may differ materially from the results described.
We encourage you to review the risk factors in our most recent Annual Report on Form 10-K and quarterly report on Form 10-Q. And with that, I will turn the call over to Carl Pelzel.
Carl Pelzel
Thank you, Ina. Good afternoon, and thank you for joining us today for our fourth quarter and yearend 2007 conference call.
First, let me report on the excellent progress we've made toward completing the management team that will be responsible for executing our business plan. In November, Mike Sweeney joined us as Vice President of Product Development and in February, Abid Rawn came on as Vice President of Sales and Marketing.
Mike spent more than a decade at Pfizer and several years at CV Therapeutics. I've known Abid for years and worked with him at GSK.
These are two strong individuals who complement the members of the team already on Board. Our priorities in 2008 and beyond are focused on conserving cash, driving revenue, executing cash, generating business deals and bringing new development programs to public view.
There are two critical value trading activities that we are focused on executing in the near-term. Those are the two Phase 3 registration programs for Gabapentin GR.
The approval of Gabapentin GR for postherpetic pain and for hot flashes will be transformational events for Depomed. These trials come with the substantial price tag, so we will be moving forward to partner these Gabapentin programs as soon as possible so that the cost of the trials can be covered by the deal terms of those partnerships.
We are engaged in partnership discussions with multiple parties on the three product opportunities we have before us, the two Gabapentin products and GLUMETZA. Because of the sensitive nature of these discussions, I will not comment on the stage of the discussions or their likely closing date, because this would compromise our ability to negotiate the best deal terms.
We are tightly controlling costs and driving revenue from our two commercialized products in order to minimize our cash burn. Let's look at the revenue side of that equation first, starting with GLUMETZA.
The termination of the King promotion agreement has given us an opportunity to identify a strong partner or partners to drive the growth of this product. In addition, we've received approximately $30 million in cash and a considerable supply of GLUMETZA samples, which are proven very useful as we fulfill increasing requests from physicians for samples.
Over the past year GLUMETZA prescriptions have continued to grow, and GLUMETZA has reached a $25 million gross revenue run rate. That exceeds the run rate of branded Glucophage XR and we believe GLUMETZA can grow much further.
In the fourth quarter we saw a 22% increase in total prescriptions, as compared to the third quarter. We believe the doctors and their patients are seeing the benefits offered by GLUMETZA therapy, as evidenced by the very positive response we have seen to talus sampling program we started earlier this year.
We have already fulfilled over 2500 sample requests through the program. In February, we began detailing GLUMETZA through a contract sales organization.
We engaged 33 part-time reps each with an average of 11 years of sales experience, 3 to 4 of those years in the diabetes marketplace. This temporary contract sales organization is not to replace the GLUMETZA partner by any names, but rather to preserve the current level of prescriptions, so that we are well positioned to negotiate the best deal possible with the new partner.
As GLUMETZA script levels remain high, so does our ability to negotiate a baseline or upfront payment in a commercialization deal. In short, though we are pleased to see GLUMETZA scripts holding up to our own sales and marketing efforts, we remain confident that we can close the deal with a new marketing partner or partners that will assist us in driving product revenue.
We are currently preparing for the introduction of the GLUMETZA 1000 milligram tablet. Market research that has been done with physicians indicates a significant increase in preference share for GLUMETZA in light of having both the 500 as well as the 1000 milligram tablets available.
As you may know we've received approval from the FDA in December and we plan to launch the product later this year with a new sales partner. As for ProQuin XR, we have seen prescriptions beginning to respond to their promotional push by the Watson urology and OB/GYN sales forces.
For the three months prior to the beginning of Watson's detailing efforts, prescriptions fell in average of 21% per month to a low point of 450 prescriptions in October of last year. In the most recent three months, prescriptions have grown in average of 38% per month, with an estimated number of prescriptions in February of over 1000 prescriptions.
Now while this number is still very low, it is indicative of significant physician adoption as physicians gain more experience with this product. The second component of minimizing our cash burn is, of course, controlling expenses.
Our fourth quarter expenses came in under our expected range due to careful control of our expenses and our prudent selection of exactly which marketing activities would contribute most to the sales of GLUMETZA. Turning now to our Gabapentin GR program in menopausal hot flashes; last month, we announced positive results in our Phase 2 PK/PD trial.
We are very pleased with the performance of our product. It delivered clinically meaningful and statistically significant efficacy in the management of menopausal hot flashes and exhibited a good tolerability profile.
We continue to believe that our product can be the first, safe and effective non-hormonal, non-antidepressant treatment for women with hot flashes. It is interesting to learn that yesterday Pfizer announced that they will discontinue their Phase 2 compound for hot flashes which appears to have been the same class of compound as Lyrica.
Our Phase 2 results should prove to be invaluable as we begin planning the design of our Phase 3 program and they have already proven invaluable insight to potential partners who are currently evaluating this opportunity. The primary objective of this study, as you may recall, was to investigate the relationship between blood plasma concentrations of Gabapentin, observed in menopausal women after administration of Gabapentin GR and the frequency and severity of hot flashes in those women.
We used the PK/PD modeling, and simulation is in line with recent initiatives from the FDA and will be valuable to us at our end of Phase 2 meeting with the agency. We were very pleased to see a reduction in the frequency and severity of moderate-to-severe hot flashes in all active treatment groups, with statistical significant observed in the 1800 milligram and 2400 treatment groups.
Bear in mind that this was statistical significance related to placebo for baseline to the end of treatment. Gabapentin GR is well tolerated in the study, with a total of only seven patients withdrawing due to adverse events from all four treatment groups including one from the placebo group.
The most common side effects observed were as expected for Gabapentin, headache, somnolence and dizziness. We are excited to move this important program forward as it addresses an area of high unmet medical need, especially, as concerns over the use of estrogen become more acute and as doubt deepened regarding the value of herbal remedies that are being used.
Reports related to estrogen and its link to breast cancer continued to surface; some of you may have seen in the recent reports from the Women's Health Initiative study related to mammogram abnormality that provided additional evidence of this link. The next step in our program will be to discuss the results of this study with the FDA during the end of Phase 2 meeting in the second quarter of this year.
Our objective is to partner this program in 2008 with the company that is interested in promoting Gabapentin GR for the management of hot flashes to the primary care physicians, while we will consider fielding a small focused sales force to promote Gabapentin GR in hot flashes in the 2011 time frame strictly to OB/GYN audience. We believe that the product opportunity is approximately evenly distributed between these two audiences.
For PHN, we submitted a special protocol assessment to the FDA last November on a proposed new Phase 3 trial. The FDA provided written comments to our proposed protocol that satisfied us; that we have an agreement on the protocol design and the fact that we need just one trial for approval.
The FDA did indicate that our request was not considered as special protocol assessment based on the agreements we had already reached with the agency at our end of Phase 2 meeting. We made several changes to the design of a new trial that we think will increase the probability of success.
The new study will be a 450-patient placebo-controlled, double-blind trial, with a 10-week stable treatment period, very similar to our first trial. There are two important differences, however, in this study relative to the last one.
The first is that it will be a single active arm. All patients on active drug will receive 1800 milligrams once a day.
You may recall that in the prior study, there were two active arms, a once-daily arm and the twice-daily arm. Because this trial will enroll the same number of patients as the last trial, but with one less active arm, this new study is powered to detect a treatment difference between active and placebo of just 0.4 on the Likert pain scale better than placebo.
The last trial was powered to detect a 0.7 difference. In addition, with only one active arm in a new study, we will not have the statistical penalty of having to achieve a p-value of 0.025 rather we will only have to achieve a p-value of 0.05.
The other important change relates to the eligibility criteria for this trial. The study will only enroll patients who recovered from shingles at least six months prior to enrollment rather than three.
We observed in the prior study a high incidence of spontaneous resolution of pain among patients whose shingles had cleared at least three months, but less than six months prior to the entry into the study. Our post-hoc analysis indicated that exclusion of these patients could have significantly reduced the placebo effect that we saw in the prior trial.
We made a few other changes as well. For instance, the new trial will not include in open-label extension component that may have encouraged non-responders in the prior trial to remain in the last trial.
Also we are considering clinical sites outside the US; in Russia and possibly other countries to expedite recruitment. As we have indicated previously, we intend to partner this program and do not envision participating from a sales perspective directly, as this would require a very significant sales force.
There are multiple companies interested in this opportunity at this stage of its development, so we have decided to begin the Phase 3 registration trial in anticipation of completing a deal. There are three reasons for this decision.
First, the study is ready to go into the clinic and any delay would be seen as a critical weakness in our negotiating position. Conversely, the start of the trial sent a strong signal to potential partners.
Second, the PHN program is a very important corporate asset, which becomes less valuable over time, as new therapies are constantly being developed. The recent decision by XenoPort and GSK to go back and conduct dose ranging studies in their PHN program, with Phase 2 results not anticipated until 2009, gives us confidence that we will beat GSK to the market in PHN, and this is very important to potential partners.
And third, the $13 million in external costs of the trial spans two fiscal years so which should not on its own put us in a position of having to raise equity given our current cash position, the potential for revenue growth and the near-term cash generating deals currently under discussion. We expect that the first patient in the study will be randomized to active treatment or placebo this month.
As per earlier stage pipeline products in 2008, we expect to move at least two pre-clinical programs in demand. We also plan to advance our GERD program, with additional formulation and manufacturing process development work.
These programs will require only modest out-of-pocket investments in 2008. That concludes the business review of our marketed products and clinical programs.
I will now turn to financial matters. For the full year of 2007, we reported a net income of $49.2 million or $1.05 per share, compared to a net loss of $39.7 million or $0.97 per share for the year ended December 31, 2006.
We were profitable at the end of 2007, primarily due to the one-time event of the Esprit and King terminations in the third and fourth quarters respectively. With regard to product sales, we have recognized $12.5 million in 2007, most of which were GLUMETZA sales, compared to $1.8 million for 2006.
Operating expenses for the year ended December 31, 2007 were $15.4 million and include the one-time gain of $29.6 million on termination of the promotion agreement with King, and the one-time gain of $5 million on termination of the Esprit agreements. Both of which have the effective reducing operating expenses for the year.
Operating expenses for the same period in 2006 were $49.6 million. We ended 2007 with $69.5 million in cash, cash equivalents and marketable securities, compared to $33.6 million at the end of 2006.
Mindful of the current financial environment, we performed an evaluation of our cash, cash equivalents and marketable securities to assess the extent to which our investments might have exposure to credit risk due to the sub prime market situation or other risky investment vehicles. We take a very conservative approach to our investments; they are of the highest standards and any investment risk is minimal.
We will look to strengthen our balance sheet further in 2008, aside from revenues and royalties related to the sales of GLUMETZA and ProQuin. In 2008, we see a number of potential cash generating events.
Possibilities include a marketing agreement for GLUMETZA, two potential Gabapentin GR development and commercialization agreements for PHN and hot flash indications, and our ongoing patent litigation against IVAX. Due to the combination of the King and Esprit termination, the company booked a tax provision of approximately $600,000 or 1.5% in net income for the year ended December 31, 2007.
I should note that our audit firm has not yet completed its review of our tax provision. Specifically, the availability of tax loss carry-forwards under Section 382 of the Internal Revenue Code, NOL.
If we determine that our tax loss carry forwards are restricted and the tax provision for the quarter and year end December 31, 2007 may increase materially, any such increase will of course be reflected in our 10-K. I would like to bring your attention to the fact that the study to determine if there is any limitation on our use of those net operating losses has been done by an independent tax firm, as well as the company, and the conclusion of that study supports our current provision for only $600,000 in 2007 tax.
However, this work is now being reviewed by our audit firm. Now looking forward to our projected expenses for 2008, we expect our SG&A expenses to be in the range of $24 million to $28 million for the year.
Keep in mind that this excludes profit share payments to Watson for ProQuin sales and profit share payments should we enter into a promotion agreement for GLUMETZA sales. We expect our R&D expenses to be in the range of $35 million to $40 million for the year.
Please note that the R&D expense range I just mentioned includes approximately $11 million in expenses associated with the PHN Phase 3 program and approximately another $11 million in expenses associated with our hot flash Phase 3 program. As I mentioned earlier, we anticipate all of the PHN and hot flash development expenses could be picked up by a partner, but for the sake of clarity, we have included them here.
And with that, operator I would like to please open up the call for questions.
Operator
(Operator Instructions). We'll take our first question from John Gordon with Deltec Asset Management.
John Gordon - Deltec Asset Management
Carl, thank you very much for a clear and dynamic presentation. I have a couple of questions.
The first is just to clear up something that you just said about the $11 million expenses for the Phase 3 PHN trial, and $11 million for Phase 3 hot flashes. I don't recall hearing you saying that you would initiate anything with respect to hot flashes this year.
I just heard something about hoping to have a partner by the end of the year. Is there actually going to be an initiation of a Phase 3 for hot flashes in '08?
Carl Pelzel
Yes, John, good question. Maybe I should clarify that in the presentation.
As I did mention, we have started the PHN trial. We haven't even had our discussion with the FDA on what trials would be necessary for hot flash, and our discussions with partners are going exceedingly well, especially after we launched the data.
But I felt, in order to present the most conservative view to our investors, I would need to put those costs out there. It is not my objective to start that hot flash trial, given our current cash position.
So the reason for including it is just to present the most conservative view as we can possibly on our expenses and cash position.
John Gordon - Deltec Asset Management
Okay. And then, just again, related to sort of financial considerations for this year as it relates to GLUMETZA, I'm assuming that your $24 million to $28 million of G&A expenses does not include anything for product cost for GLUMETZA?
Carl Pelzel
John, it does include, again, we are taking a very conservative approach, it does include some minimal costs to maintain the temporary sales force through June, July. I think it's very possible that we'll have a deal before then.
And, as I think I've mentioned before, we have the ability to discontinue the services of that sales organization as soon as we need to. So there are some minimal expenses in that SG&A number that relate to marketing, as well as this contract sales organization.
John Gordon - Deltec Asset Management
Right. But I take it that you are not giving any guidance with respect to GLUMETZA operating profit or revenues for this year?
Carl Pelzel
That's right. And the reason for that, John, is because there is so much uncertainty around that at this point.
The scripts, as we have seen, are continuing to hold that very nicely. When we get a new partner on board, I would anticipate that that would change for the better very quickly, and our costs associated with that would go down.
But to be conservative, we want to include those costs at least through the end of June.
John Gordon - Deltec Asset Management
Okay. And then, I don't want to manipulate the time, so I'd just ask one or two more quick ones.
If you were to put the short pattern of the doctors writing script for GLUMETZA on the map of the United States, would it be sort of one big dot around a particular geographical area, or is it equally distributed over all 50 states? What can you tell us about how the distribution of scripts is geographically?
Carl Pelzel
Sure. It's a little bit of short pattern.
But, I think we have to exclude sort of the Northern Mid-West states as not much there.
John Gordon - Deltec Asset Management
Right.
Carl Pelzel
Heavy use in California, New York; New York, specifically because of the Sweeney Law that gives new products a tier 2 status. And then along the Eastern Seaboard, Atlanta; oddly enough, one of our biggest territories is Las Vegas, and I think that's because of some managed care opportunities there.
But it's sort of West Coast to East Coast, certain amount around Atlanta, and then the rest of the country is pretty spotty. But we do have our 33 sales reps specifically targeted to where those opportunities are.
So, the sales reps that we have are not geographically distributed to cover the US, rather they are very specifically targeted where we have strong users.
John Gordon - Deltec Asset Management
Okay. So basically there is a fair bit of the populated part of the country, let's forget North and South Dakota, that hasn't really been introduced the therapeutic benefits of GLUMETZA?
Carl Pelzel
Well, they were when King was calling, was detailing.
John Gordon - Deltec Asset Management
Okay.
Carl Pelzel
So what we've done, I think everyone, if you will, a large number of doctors have been exposed to it. What we've chosen to do, because this is a short-term effort, is focus on the folks that already like the message, are already seeing side effect benefits in patients, and we're focusing on those folks to keep those scripts high.
John Gordon - Deltec Asset Management
Okay. And then one last thing on GLUMETZA, how would you describe the competitive landscape?
What are the attributes that are proving compelling for sales of GLUMETZA in relation to competition?
Carl Pelzel
Yes, it's a very good question. I think the answer to that question is what's made our partners pretty enthusiastic about the opportunity, and that is, it's a huge market and has very few competitors.
In other words, we have Fortamet out there, not proving to be very strong competitor. But frankly the biggest competitor is simply the presence of lower price generics.
And so now that we've taken the product over, as we go and talk to doctors with our own sales reps, we find that physicians that are using the product actually have personal experience with patients being able to tolerate our products, where they had prior problems tolerating the generic. So our mandate then is to go out and get doctors to actually try it in 10 to 15 patients to see that difference for themselves.
Because once they do, then we don't need to spend a lot of time and money pushing on them, as you would, if you were selling a lipid-lowering agent, for example, where the competitive environment is very tough, and where it's very hard for a physician or patient to actually witness the difference.
John Gordon - Deltec Asset Management
Right. Okay.
And then, just one last question, if I may impose on you. With respect to hot flashes, given all that has happened in that particular medical malady space, in terms of a lot of compelling only positive attributes alternate therapies, I am just curious whether the FDA might actually give you sort of accelerated kind of treatment in terms of, boy, let's get you in the Phase 3 as soon as possible, because there is nothing else out there, or because of the scar tissue associated with hormone therapy, et cetera.
Are they likely to be, in fact, more cautious than normally? I can't figure out which way seems cut in terms of the deficiencies in hormone therapy.
Carl Pelzel
And John, they are very insightful questions. Just let me say because this, we don't want to tell the FDA how they might respond, that your thoughts about what's happening with estrogen in the market is a very good one.
And certainly, we'll be discussing alternatives when we go and talk to the FDA, but really can't project how they might respond. But, frankly, I think the developments on the estrogen front, the developments with Pfizer on their Lyrica analog, and as you may recall, they also had a use pattern to the exclusive use of their analogs in hot flashes, and so that program has gone away.
And the recent data that Wyeth has communicated on Prestique with the very, very high side effect profile, I think, all works together to make us even more enthusiastic on hot flashes than we were previously.
John Gordon - Deltec Asset Management
Well, I guess, this is one last question. Given what you've just said, does that mean you have sent out your Phase 2 study to every sort of women's health organization in the country?
Carl Pelzel
No, we haven't. And the reason for that is, before we stimulate any kind of demand or use, we want to make sure that we have a product available that will deliver Gabapentin with the positive side effect profile that we feel we can deliver.
So, we certainly talk to partners about that and will be talking to the FDA about it. We just don't want to stimulate patient demand if we can't satisfy that.
John Gordon - Deltec Asset Management
Thanks so much, Carl. Keep up the great work.
Carl Pelzel
Thank you.
Operator
(Operator Instructions). We'll go next to Andy Schopick with Nutmeg Securities.
Andy Schopick - Nutmeg Securities
Thanks. I realized you want to stay away from revenue forecast per se, but I did want to ask could you just comment briefly on the deferred revenue that is on the balance sheet, and whether that deferred product sales of $6.5 million is likely to be recognized this year?
Carl Pelzel
Yeah, Andy, it's a really good question. We recognized revenue based on prescriptions that we see for the product.
And that's because we have to demonstrate that we have a strong belief that the product sold no longer has the ability to come back as a return. So we're taking a very conservative approach to that.
And as time goes on, as we see the prescriptions begin to equal the sales, at that point over time, we can begin to recognize more of that revenue that's held up on the balance sheet. But the product, as I mentioned, grew 22% in prescriptions in the last quarter of last year, and we anticipate bringing a partner on in a very near-term.
So having a good handle on that is not where we are at the present time. The dynamics of that are as follows; as a product grows more rapidly, wholesalers hold more of the product in the pipeline so they can satisfy that demand, and as they increase the channel, in the other words, the amount of GLUMETZA in the pipeline, we have to hold back, or fail to recognize more of the revenue that goes out the door.
So at some point in time, we'll reach a steady state. And the prescriptions that are generated will about equal the amount of sales for the wholesalers.
But we're not there yet.
Andy Schopick - Nutmeg Securities
Okay. What about deferred license revenue?
Can you just comment on that line item?
Carl Pelzel
Yeah. Tammy, do you want to?
Tammy Cameron
Yeah. Let me step in there for a minute.
The deferred license revenue on the balance sheet right now is primarily tied to Biovail. That recognition is about 1.5 million annually and that goes to 2023.
So, we will continue to recognize that.
Andy Schopick - Nutmeg Securities
Well, of course, there is about one point 4.5 or, 4 million, or 5 million, I think, right now under deferred license revenue.
Tammy Cameron
That's in the current--
Andy Schopick - Nutmeg Securities
In the current, right.
Tammy Cameron
Yeah. And long-term has the balance of it.
Andy Schopick - Nutmeg Securities
Okay. Thank you.
Operator
(Operator Instructions). And we will go to John Gordon with Deltec Asset Management.
John Gordon - Deltec Asset Management
Hope, you don't mind, Carl, but so I am not hogging the line, can we just spend a second or two on ProQuin, and let me just ask the same geographical question about ProQuin that I asked about GLUMETZA?
Carl Pelzel
Yes. Different answer, because Watson has broad geographic coverage of the United States for both our OB/GYN and urology sales forces, so in that case with a few exceptions, as you said North and South Dakota, we have broad coverage of the product opportunity with representatives, and that would include all major metropolitan areas and all parts of the country.
John Gordon - Deltec Asset Management
Okay. As a general matter, wouldn't people that sign up for GLUMETZA stay on it for a while, whereas people did or signed for ProQuin are using it on an episodic basis?
Carl Pelzel
Exactly right. That’s what makes GLUMETZA so attractive is the fact that, once you get patient on the product, theoretically they should stay on as long as that product is keeping their blood sugar under control, whereas uncomplicated UTIs, obviously, our antibiotics scripts that has to be thought for…
John Gordon - Deltec Asset Management
Right.
Carl Pelzel
…on a daily basis.
John Gordon - Deltec Asset Management
Right. Okay.
And then just lastly, you did throw a penalizing sense or two in your initial remarks about two compounds, that we're going to be doing something to other products that -- did you use the term be brought into the clinical, I mean what would you like us to know about those two products?
Carl Pelzel
Yeah. I guess our pipeline is really comprised at this point of three.
One is good and because we have three business development initiatives ongoing, and that being GLUMETZA and the two Gabapentin GR programs, we put GERD on hold until probably the spring, until one or more of those deals have been concluded. And we're spending our time on process development and fine tuning the manufacturing and that really complex dosage form.
The other two programs, we're not prepared to talk about them at the present time, but I can say that they have the same type of differentiation that GERD does. In other words, we do not feel that our pharmacists will be able to look at the advantages of these two other programs and simply substitute a generic product.
The same would be true for GERD. With the GERD program, we delivered a dose of omeprazole at two in the morning, and a pharmacist would not, in his right mind, be in a position to substitute generic omeprazole for that prescription.
So, there are large markets. They have a high degree of product differentiation, the formulations are essentially done.
So the next stage of the process would be to manufacture small lots for Phase 1 study that we would either do here or ex-U.S., but the cost of those, because we do the manufacturing ourselves in-house is minimal, and also because this small number of patients is needed for a Phase 1.
John Gordon - Deltec Asset Management
Very good. Thank you again, Carl.
Carl Pelzel
Thank you.
Operator
And there are no other questions at this time. I would like to turn the conference back to our speakers for any closing remarks.
Carl Pelzel
Thank you. In summary, we are very pleased with the progress we've made in 2007 and look forward to 2008 as we work to establish a greater commercial presence and advance our existing product pipeline.
Thank you for your continued support and interest in Depomed and I look forward to keeping you appraise of our progress in the coming months. Thank you.
Operator
Thank you. A replay of today's conference will be available today at 7 pm central time at 888-203-1112 or 719-457-0820, conformation code 4892180.
Once again that starting at 7 pm central time today at the number 888-203-1112 or 719-457-0820, conformation code 4892180. That concludes today's conference.
You may now disconnect.