Halozyme Therapeutics, Inc. (HALO) Q2 2016 Earnings Report, Transcript and Summary

Ladies and gentlemen, welcome to the Antares Pharma Second Quarter 2016 Operating and Financial Results Conference Call. [Operator Instructions] I'll now hand the conference over to Jack Howarth, Antares’ Vice President of Corporate Affairs. Please go ahead, sir.

Thank you, Audra, and good morning, everyone. This morning, we released our second quarter 2016 financial results and recent operating achievements and a copy of the press release can be found on the Antares Web site at www.antarespharma.com under the News section. In addition, this morning’s teleconference also contains an interactive slide presentation. If you have dialed into the audio-only teleconference, you can follow along with the slides, which can be found on our Web site under the Investor Information section. The conference call and slide presentation will be simultaneously webcast on the Investor Information section of the Antares Web site under the Webcast tab. If you are currently unable to access our Web site, the conference call and slide presentation will be archived under the Webcast tab at the conclusion of today’s call. Before we begin, I would like to remind you that some of our statements made during this conference call will contain forward-looking statements within the meaning of the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and actual results could differ materially from those projected in any forward-looking statements. These forward-looking statements may include, but are not limited to statements concerning the growth of prescriptions and sales of OTREXUP, Teva and our ability to adequately and timely respond to the complete response letter received from the FDA for the VIBEX Epinephrine auto-injector ANDA and approval by the FDA of the same; and any future purchase orders and revenue pre or post FDA approval; the timing and results of the supplemental safety study for QuickShot Testosterone, or QST; and the Company’s ability to prepare and submit an NDA for QST and FDA actions with respect to the QST program; the market acceptance and revenue from Sumatriptan injection USP; the timing and outcome of Paragraph 4 patent litigation related to Teva’s teriparatide pen program; continued progress in ongoing development programs; and actions by the FDA regarding the Company’s product candidates and those of its third-party partners, including Teva’s ANDA's for the exenatide and teriparatide pens; and AMAG’s product and any future revenue related thereto; the timing and results of clinical research and development projects; and the timing of launch of products in development and future product revenue. Forward-looking statements provide Antares’ current expectation or forecast of future events. Factors that could cause actual results to differ are discussed from time-to-time in the company’s filings with the SEC on Form 10-K and in Antares’ periodic filings on Form 10-Q and 8-K and other filings made with the Securities and Exchange Commission. Links to these documents are available on the Investor Information section of our Web site and we encourage you to review these materials. Antares is providing this information as of the date of today’s conference call and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events or circumstances after the date hereof, except as required by law or otherwise. The Company cautions investors not to place undue reliance on these forward-looking statements. Joining me on the call today are Bob Apple, President and Chief Executive Officer and Jim Fickenscher, Senior Vice President and Chief Financial Officer. Let’s review the agenda for today’s call on Slide 3. Bob will begin with an overview of the operating highlights. Jim will take you through the financial results and then Bob will give you a business update and discuss our progress against our priorities for 2016. After that, we will open the lines up to your questions. Please turn to Slide number 4. I will now turn the call over to Bob Apple. Bob?

Good morning, everyone and thank you for joining our call. I’m very pleased to discuss this morning the excellent progress we are making as we successfully execute on our 2016 plans. This morning we report a terrific financial results. Total product sales of $8.7 million grew 49% versus the second quarter of 2015. We recognized $3.3 million in development revenues, which are related to pre-commercialization activities for various alliance projects including generic Byetta, generic Forteo and branded Makena. This represents 8% growth versus the second quarter of last year, but is nearly triple the amount booked in the first quarter of this year. We also saw our operating expenses drop by 2% compared to the second quarter of 2015. We successfully met the commitment that we made to our shareholders, provide Teva with the quantities of generic sumatriptan needed for a midyear launch and we shipped $2.9 million worth of product to Teva in the second quarter. On June 27, we jointly announced the commercial availability of both dosage forms of the product. Sumatriptan injection is indicated for the treatment of migraine and cluster headaches in adults. Teva introduced the product into the market in July, which means we will see our first profit share revenues recognized in the fourth quarter of 2016. Turning to OTREXUP. Total prescriptions grew 16% versus the second quarter of 2015 and increased 9% versus the first quarter of this year. We believe that the various changes that we made to our sales and marketing strategy over the past few months will continue to have a positive impact on our OTREXUP prescriptions, and we remain confident that these ongoing efforts will continue to help drive growth in OTREXUP sales. We are making excellent progress on our QuickShot testosterone development program. In June, we made another shareholder commitment when we announced the conclusion of our QST-005 supplemental safety study. We believe this trial provides us with the safety database requested by the FDA and we plan to communicate the results of the study in the third quarter. As a result of the progress made to date, we updated our guidance on this program. We now expect to submit the NDA by the end of 2016, assuming FDA approval, this should provide for the possibility of a launch at the end of 2017 or early 2018. We also have some extremely positive news regarding two of our alliance projects. First, in June, Teva announced the settlement of a patent litigation with AstraZeneca leading to Byetta, an injectable form of exenatide used to treat type II diabetes. As a result, Teva will be able to commercialize the generic version of Byetta in the U.S beginning October 15, 2017, assuming FDA approval. Second, in May, we announced that our Pen 1 alliance project with Teva is teriparatide, which is a generic form of Eli Lilly's blockbuster osteoporosis product, Forteo. As a reminder, Eli Lilly filed a lawsuit against Teva alleging infringement of six of the seven U.S patent listed in the Orange Book in response to Teva's Paragraph 4 certification. Later in the quarter we learn that Lilly has agreed not to file a patent infringement lawsuit against Teva with respect to the seventh patent. This is important because excluding this patent means that the last to expire Orange Book listed patent runs out in August of 2019, approximately one year after the 30-month stay will end. Assuming approval by the FDA, this begins to provide clarity on a range of time when it is important to alliance project make on the market. We are very excited about this potentially large, global, commercial opportunity. I'll now turn the call over to Jim to take you through the second quarter results. Jim? Jim Fickenscher Thanks, Bob, and good morning, everyone. Let’s get started by looking at the details of revenues for the second quarter on Slide number 5. Total revenue was $12.2 million for the three months ended June 30, 2016, compared to $14.4 million for the comparable period of 2015, a decrease of 15%. However, I would remind all of you that during the second quarter of 2015, we recognized $5.1 million in previously deferred licensing revenue due to the termination of the promotion and license agreement with LEO Pharma, while no revenues related to LEO were recognized this year. Despite this lack of licensing revenues this year, the results from the sale of products and alliance based development projects, we're extremely strong in the second quarter of 2016. Product sales represent sales of our proprietary products and devices or device components to our partners. Product sales were $8.7 million for the three months ended June 30, '16 compared to $5.8 million in 2015, an increase of 49%. The increase was primarily driven by the shipment of $2.9 million of sumatriptan, $1 million in prelaunch quantities of epinephrine auto injectors, and continued growth of OTREXUP. Development revenue represents amounts earned under arrangements with partners in which we develop new products on their behalf. Frequently, we received payments from our partners that are initially deferred and recognized as revenue over a development period or upon completion of defined deliverables. Development revenue was $3.3 million for the three months ended June 30, '16 compared to $3 million in 2015. It's worth mentioning again the great progress we are making on development projects such as Makena, generic Forteo, and generic Byetta, which we believe will allow development revenues to increase throughout the remainder of this year. Licensing revenues represent the amounts recognized from upfront or milestone payments received from partners that are initially deferred and then recognized over the life of our agreements. Licensing revenue was $39,000 for the second quarter of 2016 compared to $5.2 million in 2015. The decrease in licensing revenue was primarily related to the previously mentioned LEO Pharma revenues that were recognized in June of 2015. Let's move now to Slide 6 and have a look at the second quarter financial results. Total gross profit decreased in the second quarter of 2016 to $4.9 million compared to $9.7 million in 2015. The decrease was again primarily driven by the termination of the LEO Pharma agreement in 2015. I would also like to comment on the reduction in our gross margin for the second quarter of 2016 versus 2015. There are two reasons for this decrease. First, the $5.1 million of LEO revenues recognized in 2015 had close to a 100% gross margin, which caused our rate last year to be unusually high. Second, in 2016, we shipped $2.9 million of sumatriptan to Teva with zero gross profit, which caused the margin to be unusually low. Our contract with Teva requires us to ship sumatriptan and our cost, but as Teva sells the product into the market, and we get our share of the profits flowing through product revenue, we should see our gross margins normalize. We expect to continue supplying additional sumatriptan units at our cost to Teva in the third quarter and should see the first profit share revenue booked in Q4 2016. Total operating expenses were $11 million in second quarter of 2016 compared to a $11.2 million in 2015. Net loss was approximately $6.1 million for the second quarter of '16 compared to $1.5 million in '15. The increase in net loss was primarily attributed to the termination of the agreement with LEO Pharma in 2015. At June 30, 2016, cash and investments totaled $36.6 million compared to 47.9 million at December 31, 2015. Our cash burn for the quarter was $5.5 million. We remain comfortable with our cash runway and the strength of our balance sheet and we will continue to invest in our pipeline projects and plan to manage the business through appropriate investments, and prudent cash management. With that, I will turn the call back to Bob.

Thanks, Jim. Let’s turn to Slide 7, and talk a little bit more about the excitement around the sumatriptan launch. Early indications are that Teva is pleased with the progress of the launch. This product launch is a high priority for both companies, and Teva has reiterated its commitment to strengthening its presence in the treatment of migraine and its global generic injectable business. As you can see on Slide number 8, according to Symphony, total retail prescription sales in the U.S sumatriptan auto injector market, for 2015, were approximately $200 million. Historically, there have been three primary players in this market. However, [indiscernible] will be only company supplying both the 4 and 6 milligram dosage forms as a generic. We believe that having both dosage forms combined with Teva's distribution expertise, puts the product in position to gain meaningful market share and profits for us into the future. We are truly excited by the potential for this product. Slide number 9 gives you a historical perspective of OTREXUP quarterly revenues since launch. Second quarter revenue increased 15% versus the first quarter this year and 14% versus the second quarter of 2015, resulting in the highest quarterly revenue since the product was launched. We believe the changes to our sales and marketing tactics along with the recent FDA approval of three new interim strengths will provide further opportunity for growth for OTREXUP. As the graph on Slide number 10 indicates the market for testosterone replacement therapy remains very large and is showing growth since the beginning of 2015. Injectable prescriptions have increased 20% since June of 2015 and represents almost 60% of the total prescriptions written in June of this year. We believe the switch from topical and all other low T treatments to injectables bodes well for our approach to treat hypogonadism. If approved, we believe our novel subcutaneous auto injector of testosterone should effectively address both the topical and injectable segments of the testosterone market. We also believe that the QuickShot testosterone development program is a very attractive and underappreciated value driver for Antares. QST offers patients an easy and convenient weekly dosing schedule, have shown predictable and rapid response in the Phase 3 PK study, and is virtually painless compared to other injectable options, thereby addressing many limitations associated with currently marketed products. Our goal with QST is simple. Create a best-in-class product that improves health outcomes in men with hypogonadism. Following the complete response letters that were recently received by other pharma companies for the two oral testosterone products in development, we also believe that we have a great opportunity to be the first next-generation TRT product approved in the United States. Let's move to Slide number 11 for a discussion on generic Byetta. As I mentioned earlier on today's call, Teva announced the settlement of patent litigation with AstraZeneca leading to Byetta, which effectively allowed Teva to manufacturer and commercialize the generic version of Byetta. Teva's ANDA is currently under active review at the FDA. According to the settlement, Teva can commercialize this generic version of Byetta in the U.S beginning October 15, 2017, assuming FDA approval. The ANDA was filed in December of 2014 and we believe Teva has first to file status, which will give them 180 days of marketing exclusivity. Symphony reported retail sales of Byetta in the United States in 2015 of $300 million. AstraZeneca is currently in the process of switching patients from Byetta, which is dosed twice a day to Bydureon, which is dosed once a week. According to Symphony, combined U.S retail sales of the two products is approximately $1 billion. What makes this interesting is that both products contain the same active pharmaceutical ingredient exenatide. By Teva's generic exenatide would only be substitutable for Byetta at the pharmacy. We believe that managed care plan may require patients to step through a generic Byetta before moving to Bydureon. Our agreement with Teva for this product provides for a margin on our supply devices and a high single-digit to mid-teen royalty on overall product sales. We also expect exenatide development revenues to increase in the balance of 2016, given where we are in the pre-commercialization process. Now let's turn to Slide number 12, for an update on the generic Forteo project. Early in the second quarter, we announced the FDA's acceptance of Teva's application for generic version of Forteo. It's our belief that the acceptance of this application as in ANDA, is extremely positive event for Antares and our shareholders. Based on available information, we believe that Teva has first to file status, and if approved, could be entitled to 180 market days of exclusivity. This marks the fourth ANDA accepted by the FDA for our relationship with Teva and importantly marks the third ANDA with first to file status. We believe the potential opportunity for Teva's generic Forteo is quite large. Lilly's 2015 Form 10-K listed full-year global Forteo revenues at $1.3 billion, with $600 million coming from the U.S market. The scope of our teriparatide collaboration with Teva is worldwide. From the financial standpoint, upon launch, we will receive a reasonable margin on our supply devices and single-digit to mid-teen royalties on overall product sales. We expect to receive increased development revenues from this project for the balance of this year. Now let's wrap up my prepared remarks on Slide 13, by updating you on the progress we’ve made on our five priorities for 2016. We successfully accomplished our first priority of the midyear launch of sumatriptan. For the balance of the year, we will continue supplying Teva with incremental units for this market. With respect to our goal of submitting the QST NDA by the end of this year or early 2017, we’re now confident that we will submit by the end of 2016. The Antares team and Teva teams continue to work closely on preparing the response to the epi CRL and we believe that all issues can be addressed. With respect to growing development revenues, we’ve seen an increase in the work being performed for the Makena, generic Forteo, and generic Byetta project. And today's results speak to the progress we've made by nearly tripling development revenues this quarter over Q1 of 2016. And finally, we are continuing to grow OTREXUP prescriptions and revenues, which we believe are due to the changes in our sales and marketing tactics. We believe the continuation of these tactics and the availability of the interim dosage strengths, should allow us to see continued growth. This has been an extremely productive quarter for us on both the commercial and development fronts. We know that we must stay focused and execute against our plan in order to achieve our objectives and make meaningful progress on what believe are the drivers of value. I remain confident that 2016 will be a very successful year. Thank you for taking the time to be with us this morning. Operator, we have finished our prepared remarks for today. Could you now open the lines for questions-and-answer session?

Thank you. [Operator Instructions] We’ll go first to Anthony Petrone at Jefferies.

Thanks and good morning guys. Congratulations on the quarter and all the progress. I’ll start with Sumatriptan, and maybe just an update on market sizing. Teva’s initiatives with managed care organizations, where the discussions are at this point? And once Sumatriptan begins to roll in, maybe the overall impact of gross margins of the company, and then I have a couple of follow-ups.

Sure. I’ll take the first part of the question, and Jim, can take the second part on the margins. Obviously for -- the Sumatriptan market it remains pretty constant in the injectable space. People who don’t have an effective treatment with oral tablets clearly move on to the injectables, and it's used pretty widely across the country. There is four generic players in the market today including us. And Teva has done a really good job of presenting to the market the reasons why their product is superior with regards to various things considering -- we think we have the best device, and on top of that there are certain storage conditions that clearly are better for our product as opposed to our competitors. So, I think that they’ve had some initial positive response from the market, and we believe that their ability to negotiate with third party players as well as the retailers will board well for this product, and we remain excited about it going forward. And I’ll turn it over to Jim, to talk about how the product works as far as margins and stuffs like that.

Sure. So, good morning, Anthony.

Good morning.

So, as I mentioned on the prepared remarks, obviously what we’re doing right now for this quarter and for the third question is simply selling final packaged product to, Teva. We do that at our cost. After the product is put into the market, Teva will do a calculation that looks at their end-sales, they’ll deduct the cost of goods that we’ve already charged them and their profit allowing for some cost of distribution to Teva is split 50-50 between the partners. So we expect that that first, that first profit share check should come in, in the fourth quarter because they actually started to put the product into the retail channels in the third quarter, so there’s a one quarter lag in reporting on that. So, when you look at it, the exact gross margin is going to highly dependent upon on what the actual selling price ends up being and what they need to do in order to get the volume, so it's a little difficult to give a precise number. But if I try to put it in the context; our development revenue and device revenue gross margin is typically somewhere in the 30% to 40% level. On OTREXUP we typically see gross margins that are kind of mid 70s. My expectation for Sumatriptan is that, when you consider the profit share which that profit share calculation will run through product revenue, and then the ongoing sale of devices, I would think that our gross margin is going to be somewhere in between the device/development gross margin rate of 40% and the 75% that we see on OTREXUP.

Very helpful. And then maybe to shift gears over to OTREXUP with the new dosage forms that you have out there and the enhanced sales force -- restructuring of the sales force. Can you give us a sense of quarterly run rates from here into the expectations for OTREXUP from this quarter? I’m not sure if this quarter had a full quarter of all those doses on the marketplace and the sales force being restructured. So correct me if I’m wrong. What are the doses out there for the full quarter if they were not, what can we expect from OTREXUP with the full quarter of all doses on the market?

Yes. So on the -- on a couple of things, clearly the effect of having the three additional interim strengths was not reflected in this quarter. They basically didn’t get into the trade until the end of the quarter. And so, we do expect to see some movement into those interim strengths over the next couple of quarters. We did not reorganize the sales force per se, what we did was reorganize kind of tactics that we were using to increase prescription growth. So we really focused on making it easy for the patients and the physicians to get the prescriptions filled. We’re making it easy for -- the messaging is much clearer, things like that. So, we didn’t do anything per se with the sales force other than reinvigorate them with better tools and better messaging, and some better programs that we think will drive prescriptions. With regards to going forward, we really don’t give guidance, but I think that what we continue to commit to is continue growth in OTREXUP. I think the market grows slowly over time, and we’re going to continue to participate in that growth and we remain committed to the program, and we think that it's a long-term value driver for OTREXUP -- I mean for Antares and our shareholders.

Thank you. And the last one would just be on Byetta. When can we expect development units to be shipped to Teva and recognized for Antares? Thanks again.

Yes, so obviously we’re still working on all the commercialization equipment finishing that up, and you’ve seen that and are reflected and our development revenue is increasing and we expect to see that continue through the balance of this year. I think that with a launch, certain date of October of ’17 assuming we get FDA approval in that interim, that gives us some time to produce the devices. So it's likely going to happen in 2017 based on the timing of where we are today. I think that again what we’re really looking to do is finish up all the tooling this year and be prepared to launch assuming approval in late ’17.

Thank you.

[Operator Instructions] And we’ll go to Wansey Lee at Ladenburg.

Hi, good morning. This is Wansey Lee on for, Matt Kaplan. So I have a quick question, would you mind reminding us for the QST trial. How do you do the dose titration and I think that is based on the two level -- at week six and then you do the titration either at [indiscernible] at week seven. How do you exactly measure the two level, and how is the titration, is it based on [multiple speakers] OTREXUP?

Right. So to kind of clarify the question, I think that really it spurs out of the lipozene issue that they saw with their dosing in their study. What I can do, I’ll tell you how kind of ours works and then you’ll see what it's pretty simple approach, and we believe the right approach. Based on our Phase II PK data that we had done before we went into our Phase III study, we knew that the 75 milligram dose will get the patients into the normal range. And so, every single patient in our study started on 75 milligrams, and of course it showed that everybody was within range is the data that we announced. At week six, they took a blood draw and based on C-trial [ph]. So basically on the lowest level of your C-max [ph] levels, we -- there was a dose -- a blinded dose adjustment made based on the level that you had. So if a patient was on the lower end of the range, they went to 100 milligrams, and if they’re on the higher end of the range, they went to a 50 milligram. And that was already preset, predefined in the study, so there was no real decision made by the physician or the patient at all. They were fully blinded, and even the physician didn’t know what dose they were getting. So at week six they took a blood draw, at week seven they started taking the new dose whether it was high or low or they stayed on the 75. And essentially our data through week 12 showed fantastic PK results where everybody was within range. We had no excursions whatsoever outside the normal range. And our average across the population was around five, six year or so. And so, we think that we hit it out of the park on the PK. We think that dosing schedule is extremely predictable and really there was no need to make any decisions even at the start of its study. Everyone started at 75, we got everybody at the normal range within 24 hours, and then they continued within that range through the whole period.

Okay, great. That's very helpful. So just to follow-up on that, I mean, at week seven do you -- could you remind us what percentage of patients are you now up titrated and down titrated?

I don’t think we gave specifics on that, but it was roughly that about half the patients stayed on 75. And I would think that around on the balance, it was almost equally split between the low dose and the high dose. And what we found and what we know in the literature too is a lot of it is based on BMI. And so, the larger patients tended to go up to the higher dose, and then the -- I would say that people with a lower BMI went down to the lower dose. And so it's very -- it's kind of predictable, and it actually resonated in the study. But it really gives the patient -- or it actually gives the physician the ability to titrate quite accurately based on the C-trial [ph] level. So, we’re really excited about the product.

That's great.

Maybe one other. So going back to the first question. So the important thing about the titration schedule is that it's something that's very reproducible within a clinical setting. So the physician after having the patient on the product will do one morning blood draw, very typical, and then based on what that PK result is that's the blood levels are and that's the decision point for whether they increase or decrease the titration. So it's very simple and reproducible titration methodology.

Right. And in the study itself, the doctor didn’t even make that decision. It was based on the blood draw that was sent to the lab, and they then received a blinded dose for the next week number seven. Obviously in practice assuming approval, the doctor will get that blood level, be able to make that determination them self based on where he thinks that patient needs to be. So again, we’re really excited about the results of our study and how easy it is to predict or to titrate a patient based on their blood levels.

Great. So, if I can just to clarify about that. So -- when you say the two level, you mentioned the morning level and how many blood draw you’ll take on week six? Do you get that till it matches the two level?

Well, when you started the study just like the FDA requires, when you enter into study to show that you are hypogonadal, and you have low T, you had to take two blood draws, and that's normal, that's in the literature that in order to access whether or not the patient needs to be on the study, you take two blood levels. One in the morning, one at night. On the study when we titrate it, it was one blood draw. And we took C-trial [ph] and we based it off of that and that's where we basically then the week seven their dose was adjusted to [multiple speakers].

Okay. All right. So you’re just basically taking one blood draw on week six compared on that level do the titration, right?

Exactly. One blood draw period.

Okay. Great. Wonderful. And maybe a last question, return regarding the epinephrine pen, you have more confidence that the question can be addressed. Do you also have any guidance, additional color on to the timeline when you think you can to the [multiple speakers]?

No. I mean, we’re following the lead by, Teva. It's Teva’s end. They’re the ones driving the regulatory process. What we’re doing is supporting that process by providing any data that they need from us or any additional information. And at this point we’re not giving any additional guidance as to when any kind of submissions we’ve made or whatnot, that's something you’ll have to talk to Teva about.

Okay. Great. Thank you very much for taking my question.

Thank you.

And that does conclude the question-and-answer session at this time. I’ll turn the conference back over to Mr. Howarth for closing remarks.

Thank you, Audra, and thanks everyone for joining us on today's conference call. If you have any follow-up questions, you can reach me at 609-359-3016. That completes today's call.

And it does conclude today's conference again. Thank you for your participation.