NuPathe (PATH) Q2 2013 Earnings Call November 12, 2012 8:30 AM ET
John Woolford - IR
Armando Anido - CEO
Keith Goldan - CFO
Michael Schmidt - Leerink Swann
Elliot Wilbur - Needham & Company
Annabel Samimy - Stifel Nicolaus
Good morning, ladies and gentlemen, and welcome to the NuPathe's third quarter 2012 earnings conference call. [Operator instructions.] As a reminder, today's call is being recorded. It is now my pleasure to turn the conference over to turn the call over to Mr. John Woolford. Please go ahead sir.
Thank you, operator, and good morning, everyone. With me on today’s call are Armando Anido, chief executive officer; and Keith Goldan, vice president and chief financial officer. Terri Sebree, president; and Jerry McLaughlin, chief commercial officer, will also be joining us for the Q&A portion of the call.
We issued a press release detailing third quarter 2012 financial results this morning. For those of you who may not have seen the release, it is available on our website at www.nupathe.com, in the Investor Relations section.
The format of today's call is as follows. Armando will begin with an overview of recent corporate highlights. Keith will then provide a summary of our financial results for the quarter, and Armando will end the prepared remarks with a brief closing, followed by a Q&A session.
Before we begin, I would like to remind you that we will make various remarks during this conference call that constitute forward-looking statements. All remarks that are not historical facts are hereby identified as forward-looking statements and include, among others, statements regarding our ability to obtain FDA approval and commercial partners for Zecuity and the timing of such events, potential benefits and commercial prospects of Zecuity, sufficiency of our cash to fund debt service and interest obligations and continue operations into the fourth quarter, and our plans, objectives, expectations, and beliefs regarding future operations, performance, financial conditions, and other future events.
Forward-looking statements are subject to numerous risks, uncertainties, and assumptions that could cause actual results to differ materially and adversely from those reflected in the statements, including those factors discussed under the heading of Risk Factors in our Form 10-K for the year ended December 31, 2011, which is on file with the SEC and available through the Investor Relations section of our corporate website.
As a result, you should not rely on any such forward-looking statements. While the company may elect to update forward-looking statements from time to time, the company specifically disclaims any obligation to do so. Also, today's call may not be reproduced in any form without our expressed written consent.
I will now turn the call over to Armando Anido, Chief Executive Officer. Armando?
Thank you, John, and thank you all for joining us this morning. Over the last few months, we have made significant progress. On our last call, I outlined four key priorities for the next 12 months that are designed to increase shareholder value.
First and foremost was to secure the necessary financial resources to achieve these objectives. In October, we completed a $28 million sale of securities. The securities were sold as units, each consisting of 1/1000 of a share of newly designated series A preferred stock, and a warrant to purchase one share of common stock. The purchase price per unit was $2.
In conjunction with the financing, we restructured our outstanding debt, and undertook cost containment measures to further extend our cash runway. The cost containment measures included a reduction in workforce, a reduction of expenditures relating to commercialization activities for Zecuity, and a delay in the filing of an IND application for MP202 until a codevelopment partner is obtained.
Collectively, these actions served to focus the company on the most important objectives for creating shareholder value: obtaining FDA approval for Zecuity, securing commercial partners, and conducting additional prelaunch activities. All told, we now have the financial resources to achieve these objectives.
Going forward, our first priority is to work closely with the FDA to obtain approval of Zecuity. Our team did an outstanding job addressing the questions contained in the FDA’s complete response letter, and during the quarter our NDA was accepted by the FDA with a PDUFA date of January 17, 2013.
We have had regular interactions with the FDA since filing, and remain confident in the approval of Zecuity. As I stated last quarter, we believe the product enhancements we made before resubmitting the NDA have resulted in an even more compelling product for migraine sufferers. Just as importantly, we are actively pursuing U.S. and rest-of-world commercial partners for Zecuity.
As the first and only migraine patch, Zecuity is uniquely positioned to address the significant unmet disease burden of migraine-related nausea and vomiting, and is an attractive, specialist-driven, near-term commercial opportunity. We believe the game-changing disruptive technology employed by Zecuity will provide it with a long patent protection. We expect that a partnership will occur after FDA approval.
Our other priority is to conduct additional prelaunch activities that build upon the extensive launch preparations we have completed over the past two years. We believe the patch has the opportunity to change the treatment landscape for migraine, by making a tolerable, non-oral triptan therapy available to the over eight million patients who frequently experience migraine-related nausea and vomiting.
Our confidence stems from 1) our continued dialogue with our scientific advisors, 2) recent data from a landmark study pointing to the significant disease burden associated with migraine-related nausea and vomiting, both in decreased patient satisfaction and markedly higher healthcare costs, and 3) the consistent feedback from our physician and patient research that Zecuity is uniquely positioned to address both headache pain and migraine-related nausea and vomiting.
As we progress toward an approval for Zecuity, we are well-prepared for commercialization. This includes market research with well over 700 physicians, more than 800 patients, and pharmacy and medical directors from insurance companies accounting for more than 130 million covered lives in the United States.
We have built a detailed field sales launch plan, including completion of physician targeting, sales territory identification, and a sophisticated geotargeting model that will allow us to optimize our marketing dollars by geographic location. We have a managed care strategy to obtain reimbursement, but it’s highly consistent with our brand strategy and product positioning.
In addition, we have constructed and are ready to implement our commercial operations infrastructure, in which we are leveraging the latest technologies to operate efficiently with seamless integration.
For our marketing efforts, we have finalized our branding and have a clear and well-defined product positioning and messaging platform focused on migraine-related nausea and vomiting that is impactful and well-differentiated from all available and developing migraine treatment options.
As an example of our ongoing initiatives, later this week we will participate in the American Headache Society Scottsdale Headache Symposium. We will conduct an advisory board with many of the thought leaders in headache, and host a scientific affairs exhibit booth where symposium participants can interact with our R&D leadership team.
I’m also excited to share that the Zecuity Phase III pivotal placebo-controlled trial was just published in the October edition of Headache, the premier journal for headache specialists in the United States. The publication highlights that Zecuity rapidly relieved both headache pain and migraine-related nausea within one hour, with a very low incidence of triptan sensations. As a result, this trial serves as the basis of the Zecuity NDA.
As you can see, we’ve been quite busy focusing on our key objectives. At this point, I’d like to turn the call over to our CFO, Keith Goldan, to review our financial results. Keith?
Thank you, Armando, and good morning everyone. We filed our form 10-Q on Friday afternoon, and issued a press release detailing financial results for the third quarter 2012 earlier this morning. NuPathe reported a net loss of $6.2 million, for the third quarter of 2012, compared with a net loss of $7.3 million for the third quarter of 2011.
For the third consecutive quarter, operating expenses totaled just under $6 million, while clinical and regulatory expenses were lower in this most recent quarter, due to the resubmission of the Zecuity NDA in July. This decrease was offset by accruals for severance costs related to the separation of our former CEO in July, as well as the reduction in force in September. As we recorded all of these related severance costs in the third quarter, we expect to begin to recognize the benefit of lower operating expenses beginning in Q4.
Research and development expenses were $2.2 million in the third quarter of 2012, compared with $3.9 million in the comparable quarter of 2011. The decrease was largely attributable to reduced spending related to Zecuity, NP201, and NP202 during the 2012 period, combined with the fact that the 2011 period included higher CMC expenses related to the purchase and manufacture of clinical supplies for Zecuity.
Selling, general, and administrative expenses were $3.5 million in the third quarter of this year, compared with $3.0 million spent during the same period last year. The increase in 2012 can be attributed to separation expenses accrued in Q3 as I mentioned earlier, partially offset by reduced activities in commercial operations during the third quarter of 2012.
Net cash used in operating activities for the nine months ended September 30, 2012 was $15.1 million, primarily as a result of spending for normal operating activities, costs incurred for the resubmission of the Zecuity NDA, as well as other expenditures for the continued development of Zecuity. During that same period, we also used $0.3 million of cash in investing activities and $6.4 million of cash for financing activities related to contractual debt repayments.
As of September 30, 2012, NuPathe had $1.3 million in cash and equivalents, and a working capital deficit of $7.6 million, compared with $7.5 million in cash and equivalents and a working capital deficit of $4.9 million at June 30, 2012.
As Armando mentioned earlier, in October, subsequent to the end of the quarter, we raised $28 million in gross proceeds from a security offering. That financing resulted in net proceeds of $26.3 million, and we now expect our existing cash and equivalents to be sufficient to fund operations, debt service, and interest obligations into the fourth quarter of 2013.
I’ll now turn the call back over to Armando for closing remarks.
Thanks, Keith. In conjunction with the financing, we also made some changes to our board. Jim Datin, executive vice president and managing director, and Brian Sisko, senior vice president and general counsel, both from Safeguard Scientifics, as well as Richard Kollender, our partner at Quaker Partners, were appointed to our board of directors on October 23, 2012.
At the same time, Jeanne Cunicelli, investment partner at Bay City Capital, and Dr. Gary Kurtzman, senior vice president and managing director at Safeguard, both resigned from the board.
We are pleased to welcome Jim, Brian, and Richard to our board. Given their backgrounds and expertise, we expect them to contribute significantly to our future success. I’d also like to take this opportunity to thank both Gene and Gary for their valuable contributions and dedication to the company over the past six years.
Again, it’s been quite a successful last few months for NuPathe. We realized two important achievements. The company received FDA acceptance of our NDA for Zecuity, and we strengthened our balance sheet.
These achievements leave us well-positioned to focus on our key objectives: obtaining FDA approval for Zecuity, securing commercial partners, and conducting additional pre-launch activities. We look forward to the January 17 PDUFA date, and remain confident in both the approval and commercial prospects for Zecuity. We again thank all of our stakeholders for their continued support.
With that, we’re now happy to take questions. Operator, please begin the Q&A session.
Thank you. [Operator instructions.] And we’ll go first to Michael Schmidt at Leerink Swann.
Michael Schmidt - Leerink Swann
I just had a question on manufacturing. Can you remind us of your long term expectations on gross margin for the product? And what’s your plan with regard to building launch inventory? Have you started accumulating product already for the launch? Or are you waiting until after FDA approval to actually ramp up manufacturing?
Let me take the first one, and it’s around launch inventory. We will actually not be producing any launch inventory ahead of approval. I think it’s prudent from the standpoint of being able to conserve our cash appropriately. And once we do receive approval, we will start the production of launch quantities at that point.
From the standpoint of gross margin, let me have Keith fill you in on that.
I think consistent with what we’ve said in the past, we would expect gross margins on Zecuity to be consistent with other commercially successful patches. Obviously we expect some volatility in the beginning around launch, but we would expect, within some time, to be right in line with other commercially successful patches, which are typically in the 60s and 70s in terms of percentage.
We’ll go next to Elliot Wilbur at Needham & Company.
Elliot Wilbur - Needham & Company
Armando, can you just talk in general terms about launch readiness? Obviously given the reduction in personnel, I would assume that some of those people or some of that was tied to some commercial folks, so I’m just sort of curious when and how ready you’ll be, assuming approval, in mid-January.
I think as I addressed in the presentation, the prepared remarks, there’s a lot of work that had been done previous to our fundraising that we just completed on the commercial front, and a lot of preparation already was in place. Yes, there were a few commercial folks that were reduced, but we think that at approval, we will be able to ramp up and ramp up relatively quickly.
Let me have Jerry McLaughlin, our chief commercial officer, actually address some of the things that were done ahead of time, and then some of the ongoing things that we have going.
From a physician standpoint, we’ve completed our branding, our brand positioning, quantitative segmentation, the messaging, so we’re really on that precipice of being ready to put together our launch materials that will support us once we have approval. And from a sales force standpoint, we’ve already aligned the territories, put the training programs in place, and we’re ready to go.
And we’ve taken it a step further with, as Armando mentioned in the remarks, a geotargeting approach that we believe will be a competitive advantage that’s going to allow us to allocate our resources more efficiently and be more effective at launch.
What this model has done, it’s taken things like physician prescribing, but not stopping there. Beyond that, including things like concentration and importance of headache centers, patient demographics. As many know, our demographic skews heavily toward female and the 25-50 year old range. And we also look at things such as income and average copays. We look at cost of local media. And last but not least, we’ve overlaid the entire managed care landscape based upon our market research and also analogs.
And what that allows us to do is really allocate those resources at launch to those geographies where we have the best environment from a physician, patient, and payer standpoint to drive the launch, and be in a position to shift accordingly. So we feel like we’re in pretty darn good shape, and we’ll be ready to launch at a time point that’s not too long after approval.
Elliot Wilbur - Needham & Company
Is there anything you can or would be willing to share at this point in terms of back and forth with the FDA that can speak something to degree of confidence in success on the PDUFA date?
I think that, as I mentioned in the prepared remarks, we’ve had good ongoing dialogue with the FDA. I think we felt very good about the package that we submitted to them. I think we had addressed all of the issues that they had put forward in the complete response letter. And I think that what we’re seeing is a very normal back and forth at this particular point. We still believe the product will get approved. And I think nothing at this particular point would indicate otherwise, that we’re doing anything other than going toward approval.
[Operator instructions.] And we’ll go next to Annabel Samimy at Stifel Nicolaus.
Annabel Samimy - Stifel Nicolaus
I guess on the back of the last two questions, what I’m hearing is that you’re not preparing any launch materials before approval. And, you know, you had taken some cost reductions in terms of commercial and maybe R&D activities. So exactly how prepared are you to be able to launch this yourselves, if in fact a partner is not there in the time that you need? And are you really in a position to be able to launch this yourself if that partner is not there?
Yeah, I think we would be in a position to launch by ourselves. Remember that from approval until we’re able to launch is going to require several things. One is I think we’re probably going to end up needing some incremental money, is an important piece for us. I think secondly we will have to produce the launch quantities, which will take some time, and is probably the critical path item.
We have prepared the launch materials to a point where getting them ready to submit to the formerly known DDMAC is something that could happen relatively quickly after approval, once the final label is adjusted and we know what it is. And then the hiring of the commercial team, post that, is something that I think we would be able to ramp up and do relatively quickly.
I do want to point out though, we are searching for a partner. We are actively in conversations. We think that a partnership will help to maximize the overall value of Zecuity, and I think that even though we’re prepared to do it in the specialist community on our own if we need to, I’d much rather be going out with a partner that allows us to really optimize this brand.
Annabel Samimy - Stifel Nicolaus
Would you require another raise if in fact the partner is there shortly after approval?
You know, the timing of a raise and the like I think is something that we don’t like to comment on. I think that the amount that we raise now obviously would not be sufficient to do a highly effective launch, but would allow us to do all of the work ahead to get ready. I think that at approval we are going to be in conversations with various partners, hopefully with a partner that brings us some non-dilutive up-front cash that allows us to effectively launch this in combination with them.
Annabel Samimy - Stifel Nicolaus
And just one more question, when you mention you’ll be prepared to launch shortly thereafter, or rather quickly, can you just characterize that a little bit? Is that a quarter? Is that two quarters? Can you give us a sense there of when we might think about adding sales to our projections?
I think you should be thinking about fourth quarter of 2013 for the launch. I think the manufacturing process takes some time to get ramped up and ready to go, and I think that’s probably our critical path item.
And at this time we have no further questions. Mr. Anido, I’ll turn the conference back over to you for any closing remarks.
Thank you very much operator, and thank you all this morning for joining us. We look forward to continuing to update you again in the coming months. Have a great day.
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