Halozyme Therapeutics, Inc. (HALO) Q3 2016 Earnings Call Transcript
Published at 2016-11-09 12:41:19
Jack Howarth - Vice President, Corporate Affairs Bob Apple - President and Chief Executive Officer Fred Powell - Senior Vice President and Chief Financial Officer
Matt Kaplan - Ladenburg Thalmann
Ladies and gentlemen, welcome to the Antares Pharma Third 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, Matt [ph], and good morning, everyone. This morning, we released our third quarter 2016 financial results and recent operating achievements and a copy of the press release can be found on the Antares website 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 website under the Investor Information section. The conference call and slide presentation will be simultaneously webcast on the Investor Information section of the Antares website under the webcast tab. If you are currently unable to access our website, the conference call and slide presentation will be archived under the webcast tab at the conclusion of today’s call. Before we begin, I’d 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 market acceptance and revenue from sumatriptan injection USP; growth of prescription, and sales of OTREXUP, the results of the clinical trials for QuickShot Testosterone, or QST; and the company’s ability to submit NDA for QST by the end of the year and FDA actions with respect to the QST program; 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 outcome of paragraph four 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 pen’s and AMAG’s product in 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 website 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 Fred Powell, 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 top line results for the quarter. Fred will take you through the detailed 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’ll now turn the call over to Bob Apple. Bob?
Good morning, everyone and thank you for joining our call. I’m pleased to report to you today another excellent quarter of double-digit revenue growth driven by record product sales. The continued quarterly increase in our top line revenue is related to our focus on growing auto injector and pen injector device sales, as well as OTREXUP sales. Total product sales this quarter of $11 million grew 38% versus the third quarter of last year. Sales of our Sumatriptan injection product to Teva, as well as the sale of QuickShot devices to AMAG help boost auto injector device sales 83% to $5.9 million versus the same period last year. The launch of sumatriptan injection by Teva in the third quarter coupled with initial device sales to AMAG to support the recently announced PK and pain studies have helped drive the significant increase in product sales and change the mix of total revenue. Year-to-date through September 30, product sales are now 80% of total revenue, versus 55% this time last year. We have made significant progress this year on both the commercial and development fronts. Total company revenue through nine months of 2016 was $38 million and I believe that we are well on our way to surpassing last year's record revenue of almost $46 million. We told you earlier this year that we would change the mix of our revenue by putting more emphasis on growing product sales due to completion of partnered programs. With the sumatriptan program complete and successfully launched, we now turn our focus to supporting Teva’s regulatory filings for epinephrine, Exanotide, and teriparatide and all three of those applications are under active review at the FDA with first to file status. Our partner AMAG initiated the definitive PK and comparative pain studies for Makena and those activities will take that collaboration once they are closer to a potential sNDA filing. In summary, we believe we are laying a solid foundation for future growth by working with our partners to move all these programs closer to approval and launch. Before we turn to the details of the third quarter financials, I like to introduce a new member of the Antares team. Last week we announced that Fred Powell has joined us as Senior Vice President and Chief Financial Officer. Fred comes to us from Celator Pharmaceuticals, where he was responsible for the company's accounting, corporate finance, and financial planning functions. Prior to joining Celator, he was the Chief Financial Officer of Orapharma where he helped develop and grow the Specialty Healthcare Company to a annual sales of approximately $100 million. Fred has a diversified corporate background, including more than 20 years of financial experience within the pharmaceutical industry. We are very excited that Fred has joined the Antares team given his many professional accomplishments within the industry. I look forward to his contributions in the future. I’ll now turn the call over to Fred for a detailed look at the third quarter results. Fred?
Thanks Bob. It’s a pleasure to be here and I’m excited to be joining such a dynamic organization with so much potential. Let's get started by looking at the details of revenues for the third quarter on Slide number 5. Total revenue was $13.5 million for the three months ended September 30, 2016, compared to $11.1 million for the comparable period in 2015, representing growth in total revenue of 22%. As Bob previously mentioned, product sales were $11 million for the three months ended September 30, 2016 versus $8 million for the comparable period in 2015. Product sales represent sales of our proprietary products and devices or device components to our partners. The increase in product sales for the third quarter was primarily driven by the shipment of sumatriptan injection USP to Teva, the sale of device devices to AMAG for the Makena program, continued growth of OTREXUP sales and sales of pre-commercial epi devices to Teva, and sales of needle-free devices. Development revenue was $2.1 million for the three months ended September 30, 2016, compared to $2.6 million during the same period in 2015. Development revenue represents amounts earned under agreements 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 development period or upon completion of defined deliverables. The decrease in development revenue for the third quarter was primarily a result of a reduction in development activities with Teva in connection with the epinephrine auto, which transition to the production and sale of prelaunch devices to Teva. Royalty revenue was $300,000 for the three months ended September 30, 2016 versus $400,000 for the comparable period in 2015. Royalty revenue is recognized primarily from in market sales of products sold by our partners. Turning now to Slide 6, total gross profit decreased in the third quarter of 2016 to $5.4 million, compared to $6 million in comparable period in 2015. The decrease in gross profit for the third quarter is primarily related to the sales of $3.4 million of generic sumatriptan injection product to Teva at cost pursuant to our agreement. We expect to receive our first profit share in the fourth quarter of this year. Total operating expenses were $11.6 million for the third quarter of 2016, compared to $11.8 million in the same period of 2015. Net loss was $6.1 million in the third quarter as compared to $5.7 million for the comparable period in 2015. Net loss per share was $0.04 for the quarters ended September 30, 2016 and 2015 respectively. Turning to Slide number 7, nine-month year-to-date product revenue increased 65% to $30.6 million as compared to $18.5 million recorded during the same period last year. Total revenue through September 30, 2016 was $38 million, an increase of 12% over the first nine months of 2015. 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. Total gross profit decreased in the first nine months of 2016 to $15.9 million, as compared to $20.4 million in the comparable period in 2015, primarily due to the termination of the LEO Pharma agreement in June 2015. Total operating expenses were $35.8 million through September 30, 2016, as compared to $34.3 million in the first nine months of 2015. Net loss was $19.8 million in the first nine months of 2016, as compared to $14 million for the same period in 2015. Net loss per share was $0.13 and $0.10 for the year-to-date periods ended September 30, 2016 and 2015 respectively. Again, the increase in net loss and net loss per share was primarily due to the termination of the LEO Pharma agreement. At September 30, 2016 cash and investments totaled $31.8 million compared to $47.9 million at December 31, 2015. I’ll now turn the call back to Bob. Bob?
Thanks Fred. Please turn to Slide number 8. As we reported to you last quarter, Teva continues to be pleased with the launch of sumatriptan thus far. We shipped another $3.4 million of finished products to Teva in the third quarter bringing the year-to-date shipments to $6.3 million. Based on the most recent weekly prescription data from Symphony, the 4 mg dose of our sumatriptan product has a 27% share and the 6 mg dose has a 17% share of the market. Combined, Teva has captured an 18% share of the sumatriptan injection market, which is quite impressive after only three months. While we are continuing to ship product in the fourth quarter, we also expect to receive our first profit split from the third quarter end market sales of sumatriptan by Teva. We believe the availability of two doses trends and the broad distribution reach of Teva will ultimately make sumatriptan adorable successful product for us. Please turn to Slide number 9. I’m happy to report continued growth in OTREXUP in the third quarter. Revenue increased 9% versus the third quarter of last year and grew sequentially versus the second quarter of this year. We sold approximately $11 million of OTREXUP thus far this year, which is a 11% increase over the same period last year. We have focused our sales and marketing efforts on product pull through and reimbursement and expect to see continued growth. Moving now to Slide number 10, I like to spend some time now talking about our very exciting proprietary program QuickShot testosterone. Last month, we reported the safety results from the QST QST-15-005 6 month’s safety study, which completed the clinical portion of the Phase 3 work. With the human factor study also complete, we are working on the new drug application and targeting a year-end submission. I like to call to your attention an important piece of data collected from the overall Phase 3 result other than the robust PK and safety results. As part of the 26 and 52 week clinical studies, we also collected assessments for injection site pain from patients. Of the approximate 2,500 injections assessed from the combined studies there were only 10 reported instances of mild pain, all others were scored as no pain. We believe that the results from the pain assessments are a real testament to our device technology and one of the many reasons why our partners choose to work with us on drug device combination products. Moving to Slide number 11. I’m pleased to report for the second year in a row data from our QST clinical work was presented at the annual meeting of the Sexual Medicine Society of North America last week in Arizona. The first abstract accepted was among a very select group of key abstracts awarded the prestige of an oral podium presentation. The presentation included a discussion of our 12-week PK data, and concluded that a starting dose of 75 mg of testosterone enanthate will achieve testosterone levels within a clinically desirable and predefined normal range. In addition, according to the authors, the study showed that testosterone administered subcutaneously with a QuickShot auto injector was safe, well tolerated, and virtually pain-free. On Slide 12, you will see that the second abstract accepted was among a select group of key abstracts awarded to distinction of a moderated poster presentation. The data also came from the 52-week Phase 3 study and was a secondary endpoint measuring psychosexual function through the use of a patient diary called the psychosexual daily questionnaire or PDQ. The PDQ is a valid data validated patient inventory used to assess among other things, sexual enjoyment, activity, and positive and negative mood for seven consecutive days. PDQ’s were administered to launch 150 testosterone deficient men enrolled in the study. Study participants completed the PDQ at baselines weeks 1, 6, 12, and week 26. According to the authors, the results of this study show statistically significant improvements in sexual functions across numerous PDQ domains. We obviously were very excited about this data. Please turn to Slide number 13. Turning to another priority program, I am happy to report on the progress we're making on the Makena project with AMAG. You will recall that we are developing a subcutaneous auto injector for the weekly administration of Makena, which AMAG believes could be a real advancement for current patients and their caregivers by combining a new potentially less painful subcutaneous route of administration with an easy to use auto injector. We believe the QuickShot device, which is the same device used for our testosterone product is a perfect fit for Makena. Last month, AMAG reported that the definitive PK study and the comparative pain steady have been initiated with the first patients dosed. AMAG is targeting a second quarter 2017 sNDA filing and anticipates a decision on approval in the first quarter of 2018. We expect to earn revenue until the filing on the sNDA and if approved we would be responsible for supplying the devices and packaging the final product for a specified margin. Additionally, we will receive high single digit to low double-digit royalties on the end market sale of the product and certain sales based milestone payments. We couldn't be happier with the progress we’ve made to date with our partner. This might wrap-up my overview on Slide 14, by updating you on the progress we made on our key five priorities for 2016. We successfully accomplished our first priority of the midyear launch of sumatriptan. We've shipped $6.3 million worth of finished products to Teva over two quarters and expect to receive our first profit split in the fourth quarter of this year. With respect to our goal of submitting the QST NDA to the FDA by the end of this year, we announced completion of all clinical work for the application and we expect this mission to occur by December 31 of this year and anticipate a 10-month review by the FDA. The Antares and Teva teams continue to work closely on their response to the epi CRL and we continue to believe that all questions can be addressed. With respect to growing development revenues, we continue to work on the teriparatide and exenatide projects with Teva and remain optimistic about the active reviews at the FDA, our first to file generic versions of Forteo and Byetta. Additionally, AMAG continues to make progress on the clinical program for the Makena auto injector and is targeting a supplemental NDA to the FDA in the second quarter of next year. And then finally, we are continuing to grow attractive prescriptions in revenues, which we believe are due to the changes in our sales and marketing tactics. We believe these tactics should allow us to see continued sequential growth. In summary, this has been another extremely productive quarter for us on both the commercial and development fronts. When you consider the applications currently under active review at the FDA, coupled with the QST and Makena applications to be filed in the coming months, we had a potential for five approvals over the next two years. Exanotide, QST and epi in 2017, and Makena and teriparatide in 2018. So, I think you understand why I’m confident that the remainder of 2016 will cap a very successful year building momentum for what looks to be a very exciting future. Thank you very much 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 the question and answer session.
Thank you, sir. [Operator Instructions] We will go to Matt Kaplan with Ladenburg Thalmann.
Hi guys. Thanks for taking the questions, and congrats on the progress. Initially, can you give us a little bit of a sense in terms of the QST opportunity and what your plans are from a sales organization and strategy there from a commercial point of view?
Sure, thanks Matt and thanks for the question. As far as QST, we obviously believe it is a very big opportunity. There is over 6 million prescriptions written in a year for testosterone products split by gels versus injectables. The injectables actually is doing more than the gels at this point, so I think that bodes well for our product. We believe that we have a product that addresses both sides of that market, both the gels and the injectables. So what we are going to do is, we are going to build a sales force that targets the high decline prescribing testosterone doctors focusing on neurologist, endocrinologist and their primary care. We believe we can penetrate a very substantial amount of those prescriptions or doc’s with a sales force of about 75 reps. It will be in that range we are still targeting looking at the different territory sizes and the penetration, but our intent is to launch that product at the end of 2017, early 2018 with our own sales force as you know. With OTREXUP, we’ve been able to build the infrastructure internally, [indiscernible] marketing organization, we currently have approximately 34 reps with OTREXUP. They are not obviously going to be detailing the testosterone doctors, but we have the in-house supply chain, we have in-house marketing, in-house payers, structures, so I think we’re very much prepared for launching this product into the testosterone market, we're really excited about it.
Great. And shifting gears a little bit in terms of your agreement with Teva, good amount of revenues from device sales, how should we think about those going forward as these - some of these products get either to the market or and continue on the market.
Well as you know we don't give guidance at this point because we are still launching a lot of the - or potentially launching new products that we don't know what the penetration will be initially, whether it’s Teva or AMAG or ourselves. What I would say is, we expect the device revenue to continue to grow, obviously we’ve been very happy with sumatriptan and it’s just only in the first three months of that launch, and we believe Teva has the ability to increase their market share over time, given their presence in the generic space. The auto injectors that we sell to this point, whether it’s the sumatriptan or the OTREXUP auto injector has been received well by patients and physicians. So we wouldn't expect that trend to change going forward. We think we have a very high quality product that patients react well to, particularly around the pain data. Almost all of our injectors are almost virtually painless. And I think that goes a long way for the product, but again when their generics is really a function of contracting the pull through by our partner Teva, and I think that’s what’s really going to drive the growth in these products for us. So it’s really a difficult question for me to answer. I'm not trying to evade it, I just don’t know right now where the - how big the other opportunities are going to be, but we obviously continue to believe we're going to see nice growth in our product revenue for the foreseeable future.
Right, and then can you give us a sense in terms of what the timing potential is for the Epipen program or anything you could add?
Yes, typically at this point Teva has already had their earnings call, but I think they are having theirs tomorrow. So, we haven't had the advantage of hearing what they publicly stated to the market. What I can tell you is, that, the two teams are working really well together and we are looking to get this approved in 2017. The timing of the launch is really a function of when it gets approved and I think that Teva is in a better position to answer that question. We’ve shipped them, a large number of prelaunch devices as you know, we continue to ship them today in preparation for a launch, and we clearly believe we've delivered sufficient devices or enough devices for the launch and so does Teva, so we will be prepared once we get that approval to turn those into finished products in a very short period of time and so again, we believe that we’ll get everything answered for the FDA and we're looking forward towards hoping approval in 2017.
All right. Thanks for the added detail.
[Operator Instructions] We have no additional questions. I’ll turn the call back to Mr. Howarth for any additional or closing comments.
Thank you, Matt. And thanks again 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 again that does conclude our call for today. Thank you for your participation. You may disconnect at this time.