Zogenixs CEO Discusses Q2 2013 Results - Earnings Call Transcript

Aug.10.13 | About: Zogenix, Inc. (ZGNX)

Zogenix, Inc. (NASDAQ:ZGNX)

Q2 2013 Earnings Call

August 8, 2013, 4:30 pm ET

Executives

Zack Kubow - Investor Relations, The Ruth Group

Roger Hawley - Chief Executive Officer, Director

Stephen Farr - President, Director

Ann Rhoads - Chief Financial Officer, Executive Vice President, Treasurer, Secretary

Analysts

Tim Lugo - William Blair

Joshua Riegelhaupt - Stifel

Michael Schmidt - Leerink Swann

Angad Verma - Oppenheimer

Operator

Good day, ladies and gentlemen, and welcome to the second quarter 2013 Zogenix Incorporated earnings conference call, My name is Celia and I will be your operator for today. As this time, all participants are in listen only mode. Later we will conduct a question-and-answer session. (Operator Instructions). As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the conference over to your host for today, Mr. Zack Kubow. Please proceed, sir.

Zack Kubow

Thank you, Celia and thank you all for joining us this afternoon. With me on today's call are Roger Hawley, Chief Executive Officer, Dr. Stephen Farr, President, Ann Rhoads, Executive Vice President and Chief Financial Officer and Scott Shively, Executive Vice President and Chief Commercial Officer. Earlier today, Zogenix issued a news release announcing the company's financial results for the second quarter 2013. We encourage everyone to read today's news as well as Zogenix's quarterly report on Form 10-Q which will be available on the company's website at www.zogenix.com.

Please note that certain of the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Zogenix management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these 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 Zogenix's news releases and SEC filings including its annual report on Form 10-K.

This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast, August 8, 2013. Zogenix undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

Now I would like to turn the call over to Roger Hawley, Chief Executive Officer of Zogenix.

Roger Hawley

Thank you, Zack, and thanks everyone for joining our second quarter 2013 conference call. Despite the continued delay in the FDA's final decision on Zohydro ER NDA, we did have productive second quarter that include continued progress in these key areas. We have ongoing interactions with FDA on Zohydro ER. We refocused our commercial operations, including a new co-promotion for Migranal and we have begun the efforts in that regard. We advanced our new product pipeline and business development efforts and we also made the difficult but necessary decisions implement cost controls initiatives including a 37% reduction in our workforce, which extends our cash runway while retaining our core commercial capabilities to support our specialty migraine business and the potential launch of Zohydro ER.

Unfortunately, for all stakeholders, including a large number of patients who continue to use hydrocodone acetaminophen combination products for chronic pain which exposes them to avoidable safety risk, we are still faced with ongoing delay from the FDA on our Zohydro ER NDA. We are now in the six-month of delay. We know the toll on Zogenix's shareholders and employees has been heavy and we have also had to delay some of our product development programs. I assure you we are working tirelessly towards the goal of gaining approval of Zohydro ER and advancing our pipeline.

This includes developing a new ADT formulation of Zohydro ER in accordance with the new FDA guidelines which actually encourage making investments for new abuse-deterrent formulations. We remain fully committed to making important contributions to the treatment of chronic pain over the long-term. We are working closely with FDA to take every appropriate step required while preparing for a voluntary safe use initiatives with the launch of Zohydro ER, if approved.

I will now give you a quick update on our commercial business and cost reduction initiatives and then Steve will follow-up with a pipeline update, including more details on specifics around Zohydro ER and then Ann will review our financial progress and update.

During the second quarter, we achieved net product revenue on sales of SUMAVEL DosePro of $8.9 million, up 11% year-over-year and up 28% sequentially. We generated approximately 20,000 prescriptions in the quarter with a refill rate of 43%. We achieved these results despite reducing the size of our sales and marketing team to 69 people in early June, including 12 part-time employees compared to 102 people at the beginning of the quarter. This demonstrates the strong dedication and commitment of our team and their ability to drive adoption of SUMAVEL without with more physicians and patients.

We also continue to work closely with our co-promotion partner, Mallinckrodt to leverage their strong relationships in pain management space to secure new interest in SUMAVEL. Mallinckrodt recently completed their spin out from Covidien and we are pleased that this major accomplishment was successfully executed. This positions Mallinckrodt for long-term growth as they work to build their brand of pharmaceutical business.

in June, both teams introduced our next generation Migraine Toolbox or our patient starter kit in conjunction with our presence at the National Headache meetings and in support of National Migraine Awareness Month. This generation three of our Migraine Toolbox highlights the importance of having the appropriate medication in a patient's treatment toolbox to address the specific types of migraine attack the patient is experiencing. We have received positive feedback on the updated migraine toolbox and we will continue to use it is a key tool to support our physician and their patients.

Near the end of June we entered into an exclusive U.S. co-promotion agreement with Valeant Pharmaceuticals for their Migranal Nasal Spray product. Migranal is indicated for the acute treatment of migraine headaches with or without aura. It is complementary to SUMAVEL DosePro and supportive of the migraine treatment guidelines and the toolbox approach we have been promoting with physicians and patients. We believe that our sales force, many of whom previously promoted Migranal, is well positioned to expand its adoption among our customer base of neurologists and headache specialists.

Since entering the agreement, we have worked very closely with the Valeant team to train our sales force on Migranal and our team began selling Migranal on August 1, and while still early in the rollout, we have received positive initial feedback from our sales team and our customers on the important role that they play alongside SUMAVEL DosePro and oral medications in treating migraine. We believe we have a long sales runway in migraine and we are continuing to pursue additional migraine product opportunities to be marketed by our specialty team. This customer focus makes good economic sense and we remain committed to serving physicians and patients suffering with migraine as a core part of our business.

We believe this agreement with Valeant fits well with our vision of being a leading specialty migraine company and helped drive our commercial operations towards profitability. This focused effort will support the business initiatives we announced in early June to extend our cash runway during this final stage of the NDA review process on Zohydro ER and it keeps us fully prepared to expand our team and launch Zohydro ER, if approved.

As I stated at the time, the reduction in force was a difficult decision for the board and the management team but we continue to believe it was the right decision for our shareholders based on the circumstances we have been facing with Zohydro ER. During the quarter we make good progress transitioning to a leaner operating structure and have implemented several cost-saving initiatives to further conserve cash. In addition, we have selectively utilized our At The Market facility to raise a modest amount of additional capital giving us adequate resources to reach potentially upcoming milestones, including Zohydro ER approval, partnering for Relday and out licensing of DosePro needle-free delivery system.

Now I will turn the call over to Steve Farr for an update on our new product pipeline encouraging progress in our related business development efforts. Steve?

Stephen Farr

Thank you, Roger. I will begin with a quick update on the status of Zohydro ER. We continue to expect the FDA will make a decision on our NDA during the summer. This is based upon very recent interactions with the agency in which they have confirmed the NDA is in active discussion. They are working as fast as possible and nothing has changed with respect to an action this summer. Importantly, they have restated there are no deficiencies in the application. We are continuing to patiently wait as the FDA concludes its review of the NDA for Zohydro ER and remain prepared to launch the product three to four months after potential approval.

Turning now to our other development programs. During the quarter, we continued to make progress on Relday and our DosePro co-marketing efforts with Battelle. Relday is our proprietary, once-monthly subcutaneous formulation of risperidone for the treatment schizophrenia. We are making good progress with seeking a strategic and commercialization partner and through our collaboration with Locust Walk Partners who are leading the business development efforts. We have been impressed with the caliber of interested companies who appear to share our excitement for the global product opportunity.

Since we announced the positive topline results from our extended Phase 1 clinical trial in early May, we have concluded a large, quantitative research study with psychiatrists in United States and Europe to assess advantages or disadvantages of Relday relative to current long-acting injectable options. The majority of psychiatrists had positive to very positive reaction to Relday. Both European and U.S. psychiatrists rated the ability to achieve therapeutic plasma levels on the first day of dosing as the overwhelming favorite attribute as it means simplifying the loading measurement compared to all currently available long-acting injection products.

The once-monthly dosing frequency and no requirements for reconstitution were also highlighted as key advantages for our risperidone product. There were no disadvantages expressed compared to the comparative products. We are now preparing for the next clinical trial, a multiple dose PK safety study in patients with schizophrenia which we intend to move forward once we have secured a partner or have obtained approval for Zohydro ER.

We are also seeing good progress in our efforts to partner the DosePro technology for the self injection of biologic products. In May, MedImmune published a scientific work at the 2013 AAPS National Biotechnology Conference which showed in vitro the integrity of two recombinant human monoclonal antibodies was unchanged after instantaneous injection by the DosePro delivery technology. Another publication from our scientific collaboration with MedImmune focused on the ability of the DosePro technology to successfully deliver high viscosity solutions. Typical of high concentration monoclonal antibodies formulations that are problematic to administer with needle-based autoinjectors.

In addition, our co-marketing partnership with Battelle is beginning to result in real progress, in that several potential partners are now in deep diligence and/or are preparing to conduct clinical and technical work with the DosePro technology. We are very encouraged by the progress to-date and hope to convert one or more of these relationships into a licensing deal for DosePro delivery of biologics.

Now, I will turn the call over to Ann for a financial update.

Ann Rhoads

Thanks, Steve. During the course of our discussion, I will be referring to today's press release and to the attached unaudited statements of operation and the balance sheet. I will be rounding numbers for purposes of this call, so please refer to these documents for the precise figures.

Net product revenue for the second quarter of 2013 was $8.9 million, up 11% compared to the $8 million in the second quarter of 2012. The increase was driven by a higher net selling price in the second quarter of 2013 compared to the prior year period. Some of our prescriptions were maintained during the quarter as compared to both the second quarter of 2012 and sequentially from the first quarter of 2013. This was achieved despite the by Zogenix team having fewer reps in the field compared to a year ago and sequential periods including the reduction in force that lowered the rep count in June.

Refill rates remained steady which is positive for the long-term outlook of the brand. We are focusing on driving new patient starts across the continuum of physicians and our specialists in high volume segments. In the Mallinckrodt segment, their team of reps delivered improved results throughout the quarter. We believe they are on a positive trajectory and both our teams remain committed to drive adoption of SUMAVEL DosePro in their segments.

I also want to provide a brief update on some of our prescription trends as tracked by Source Healthcare Analytics and IMS health. As we have reported on our year-end and first quarter calls, the IMS Health data appear to be tracking much higher than the data provided by Source Healthcare Analytics. Approximately 18% higher during the first half of 2013. While we don't have the drivers of this discrepancy, we want to be transparent regarding the situation, in case you use the IMS prescription data in your analysis.

Finally, our wholesale inventory levels declined to approximately 3 weeks from the four weeks at the end of the first quarter 2013 and at the end of 2012. Cost of sales for the second quarter 2013 were $4.6 million, compared to $4.2 million in the second quarter 2012. Our gross margin was 48% in the second quarter of 2013, unchanged from the prior year period. Royalty expense for the second quarter of 2013 was $338,000. This reflects royalties that we paid to Aradigm on the sales of SUMAVEL DosePro and this compared to $315,000 in the second quarter of 2012.

Research and development expenses in the first quarter of 2013 were $3.6 million. This is a 44% decrease from the $6.4 million in the second quarter of 2012. This decrease was driven by lower development costs associated with Zohydro ER. Selling, general and administrative expenses for the second quarter of 2013 were $12 million, a slight decrease from the $12.1 million in the second quarter of 2012.

We are continuing to move forward with our pre-commercial planning activities for Zohydro ER but have strategically decided to wait for approval to begin any significant spending related to Zohydro. If approved, we are prepared to move forward with the remaining prelaunch activities, which will put us in a position to launch Zohydro in three to four months post approval.

Our second quarter 2013 operating expenses included an $876,000 restructuring charge related to the company's previously announced cost control initiatives. Other expense for the second quarter 2013 was $900,000, which includes a $1.3 million non-cash mark-to-market adjustment in the fair value of the company's outstanding warrants. We have provided a table with a full description of the other expenses in our press release issued earlier today.

Our net loss for the quarter was $13.3 million or $0.13 per share, compared to a net loss of $17.2 million or $0.26 per share in the second quarter of 2012. non-GAAP net loss for the second quarter 2013, adjusted for certain non-cash or nonrecurring items, was $0.13 per share. The non-GAAP financial results are detailed in a table included in our financial press release issued today.

Weighted average shares outstanding for the second quarter of 2013 were 100,876. we finished the quarter with cash and cash equivalents of $16.1 million. As Roger mentioned, as of August 7 the company had agreed to sell 3,013,724 common shares at a weighted average price of the $1.66 per share for a total of $5 million in gross proceeds under our $25 million At The Market facility. No proceeds from sales under this agreement are included in our June 30 cash position. We have made the strategic decision to utilize the ATM to raise a modest amount of capital in order to maintain an adequate cash position as we wait for the FDA's decision on Zohydro ER and other important potential milestones. Because of the pending decision from the FDA regarding the potential approval of Zohydro ER and the related business implications, the company is not providing financial guidance at this time.

I will now turn the call back over to Roger for an update on our other new product initiatives. Roger?

Roger Hawley

Thank you, Ann and Steve. I will do a quick wrap up and then we will go to questions and answers. Overall, we have made good progress during the second order on initiatives to improve our commercial operations by better leveraging our sales force and focusing on efficient growth. We have combined this with the cost reduction initiatives that will extend our cash runway while retaining our core commercial capabilities.

On the development front, the Relday program is on track and we continue to focus on securing a development and commercialization partner. Our collaboration with Battelle for the DosePro system is receiving strong interest and we are encouraged by the potential in licensing opportunities, particularly for patient administered biologic products.

Lastly, we continue to wait for a potentially significant value creating milestone in the FDA's decision on Zohydro ER sometime this summer. If approved, we are positioned to execute on prelaunch preparations that would allow us to bring Zohydro ER to the market within three to four months of approval. While still delayed, Zohydro ER is still a very important new product in a therapeutic class where we can make a positive impact and offer patients the first acetaminophen free hydrocodone product for chronic pain.

Operator, I would now like to open it up for questions from those that called in.

Question-and-Answer Session

Operator

(Operator Instructions) The first question comes from the line of Tim Lugo from William Blair. Please proceed.

Ann Rhoads

Operator, I don't know if Tim's line is opened up, but we cannot hear him.

Operator

One moment, please. Please proceed, sir. Your line is open.

Tim Lugo - William Blair

Okay, great. I just wanted to find out, as we wait for the Zohydro decision, I just wanted to ask about Plan B for the company, if Zohydro is not approved. Will you be looking at ABT technology or you are just going to move on with Relday and your Battelle DosePro partnership?

Roger Hawley

Yes, Tim. That's a great question. First, I will just reinforce, well anything could happen. Based on the dialogue that we have had with the FDA, we believe we should still obtain approval. It's a matter of time. However, we have given a lot of thought to backup plans and depend upon, if we get some kind of a letter or complete response from the FDA, it would depend on what's included in that as far as any additional requirement.

We have said all along that we want to advance an ADT form of the product but as you know we just recently got guidance. There a lot of technologies out there, some which have not shown to work very effectively and others, we believe can. So there is a lot of R&D work ahead to advance something there, which we are interested in doing. We will definitely do if we get approval.

As far as, would we just abandon Zohydro, it would really depend upon the very detailed circumstances around a complete response letter. We do have a backup plan, if you will, and that would include focusing on our migraine business. One of the reasons we are focusing on that as a core capability. We think its an area of expertise and experience that we have. There is a lot of upside potential in presenting the treatment guidelines as the appropriate way to treat migraine patients. We want to be an important player in that space.

Relday is a compelling global product opportunity. We will definitely want to advance that as quickly as possible. Again, with or without Zohydro. So we would do our best to refocus and to size appropriately. We think we have sort of taken that step as a backup plan. And as I mentioned, we are continuing to look for another migraine product to put in our bag which makes sense, with or without Zohydro.

So I hope that answers your question.

Operator

The next question comes from the line of Annabel Samimy from Stifel. Please proceed.

Joshua Riegelhaupt - Stifel

Hi, guys, this is Josh sitting in for Annabel. A quick question. In terms of, I am not going to ask you about what's having with FDA and Zohydro but August is probably up in three weeks or so. If you guys don't hear back from them, is there going to be a way, you are going to communicate with us and others if things creep into September and even later, about a delay or not?

Roger Hawley

Well, like they have told us now, and reinforced that, its sometime this summer. If we don't have an outcome by the summer time, we will definitely be updating everyone about where we are at and anything that we have learned along that process with the FDA. Steve and his team have been in contact with the FDA, as you would expect, given where we are at and as we are sitting here today, we do still believe that based on these interactions that we would get approval and they have recently reiterated it would be sometime this summer, but to your question directly, when we learn anything, we update everyone appropriately.

Joshua Riegelhaupt - Stifel

Okay, and a question about Migranal. It has been probably its been around for a little while. I am kind of curious what your plan is in terms of positioning it and how you rebranded it a bit to physicians. Then unrelated to the financing, but can you talk about the revenue sharing that's going on with Valeant?

Roger Hawley

Yes, well, in general we have been trying to teach physicians and help them instruct their patients about how to treat acute attacks based on the past experiences that they have had with their medications and the severity and circumstances of that individual attack. We think SUMAVEL DosePro really helps drive that point home about how to use attack-based care and further there are some patients who just have shown that they don't do well on triptans.

We feel it's appropriate that they first try subcutaneous sumatriptan before you draw that conclusion that they are triptan non-responder. Trying them on oral isn't enough. So there has always been a place for DHE used by headache specialists and some neurologists. There is appropriate positioning per the guidelines and we think all of our efforts to teach the various elements of how to treat these more severe patients who have complex attacks is right in line with what we do and it is where the market is headed and where the future of migraine treatment will be.

There has also been considerable interest in DHE based on other products that been in development and Migranal has not been promoted for quite some period of time. They were shipping samples to key prescribers but we would even occasionally get questions about it from our own sales reps because some of them had sold that product in the past. It's a great fit. It's a pure call point overlap with SUMAVEL DosePro. We think it fits with everything that we are trying to do as a company. So it made sense.

On the economic split, we haven't been able to disclose a lot of the details based on our agreement with Valeant, but what we have said is that we have a baseline of prescription activity for the brand. What we are trying to do is generate upside revenue on the product that will continue to book that revenue. We will receive a service fee based on our performance above that baseline and a sharing of net revenue which we have not disclosed the percentage on. But it's a, I would call, sort of a classic example of a performance-based structured co-promotion agreement.

Operator

(Operator Instructions) The next question comes from the line of Michael Schmidt, Leerink Swann. Please proceed.

Michael Schmidt - Leerink Swann

Thanks for taking my questions. I had one on the interactions with the FDA. Just briefly, when did you have your last interaction and did the interaction originate from you or did the FDA come forward to contact you? Its my question and then I have a follow up.

Roger Hawley

Yes, Michael, this is Roger. Steve may want to fill in some detail here but I don't know if I will get into just the blow-by-blow but I would just say that we have had, what you would consider normal interactions, during the final stages of a review of an NDA that included our head of regulatory, Steve Farr has been involved in some of those discussions and occasionally I have been involved, not very frequently but occasionally I have had some role in the interaction. We are continuing to do things that you would expect to be done at the end of a review process. We think normally, and the market would expect the very last thing that would occur would be labeling discussions and we expect that to be the next step that is taken.

Michael Schmidt - Leerink Swann

Okay, great, thanks. Very helpful. I noticed the gross to net adjustment for SUMAVEL DosePro was a bit lower than in the last few quarters, and I was wondering whether the current rate is a good assumption going forward?

Ann Rhoads

Michael, I do think that's a good rate on a go forward basis. we continue to evaluate the return reserve for return product. I would say I think that's a good assumption in your model.

Michael Schmidt - Leerink Swann

Great, thanks, and then one on the potentially abuse-deterrent formulation for Zohydro. What stage are you in exactly? Are you looking to license the technology at the moment? I think there has been some movement in that area recently. Would that potential product quality for a pretty short bioequivalence possibly as opposed to a efficacy trial?

Roger Hawley

Yes, Steve will take that one, Michael.

Stephen Farr

Yes, Michael. We have been working with Alkermes for a little while on an abuse-deterrent formulation. I think we have talked about that before. I think we even talked about it at the outcome last December. Really, the assumption there, which has been demonstrated in a our first clinical trial is that it would be a bioequivalence pathway to our existing safety and efficacy data. So there would be no requirement at all to repeat Phase 3.

There will be a number of pharmacokinetics studies that will be needed to be conducted to ensure the appropriate scientific bridge, as well as to conduct the human abuse liability trials which are laid out actually in the guidance. So mainly Phase 1 data, no Phase 3 data required to make the bridge.

Michael Schmidt - Leerink Swann

Okay, great. Thank you.

Roger Hawley

Michael, this is Roger. I would just add to it. Longer-term, on ADT, and we have all learned a lot as the FDA has about the new guidelines as well as the data that was made available around Purdue process and Endo and, as I said, we want to be committed to this space for a longer-term. We are going to keep looking at different ADT technologies and some companies who have those technologies because we are sort of in the pole position in hydrocodone space. We are getting an opportunity from companies expressing their capabilities to us of new approaches in ADT formulation.

We obviously look at those things as those opportunities come our way and we will continue to do so as we move forward in the pain space. As the FDA is trying to do, encourage new ADT development, even the products on the market today, some have demonstrated a benefit, others less so, we would like to help advance a technology that actually offers the community a benefit that we are all looking for and the FDA is trying to seek and encourage. So that's the path that we will be on. We are looking more broadly as well.

Michael Schmidt - Leerink Swann

Okay, great, thanks. Very helpful.

Ann Rhoads

Michael, one follow-up on your growth to net question. We did take a price increase at the end of April and so the right price now is at $98.89. So I think if you make sure that is falling through in your model, it would be probably helpful as well.

Roger Hawley

Operator, do we have any other questions.

Operator

Next question comes from the line of Angad Verma from Oppenheimer. Please proceed.

Angad Verma - Oppenheimer

Hi, guys. Thank you. Actually all of my questions have been answered.

Ann Rhoads

All right, Angad. Well thanks for being on the call. We appreciate it.

Roger Hawley

Did you have a question?

Angad Verma - Oppenheimer

No.

Roger Hawley

Okay.

Operator

Mr. Verma, your line is open, sir. Please proceed.

Angad Verma - Oppenheimer

Oh, sorry, hello.

Operator

Yes, your line is open, sir.

Angad Verma - Oppenheimer

Yes, sorry, I have all my question have actually been answered.

Roger Hawley

Okay. I am sorry. I didn't hear that. Sorry about that. Operator, any other questions?

Operator

There are no further questions at this time.

Roger Hawley

All right. Well, I want to thank everyone for joining us on the call today and we look forward to our next communication and we will keep you advised as we progress the Zohydro ER NDA with the FDA. Thanks very much.

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. Have a wonderful day. You may now disconnect.

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