Allergan Plc (NYSE:AGN) Q1 2019 Earnings Conference Call May 7, 2019 8:30 AM ET
Manisha Narasimhan - Vice President of Investor Relations and Strategic Initiatives
Brent Saunders - President and Chief Executive Officer
Bill Meury - Executive Vice President and Chief Commercial Officer
David Nicholson - Executive Vice President and Chief R&D Officer
Matt Walsh - Executive Vice President and Chief Financial Officer
Bob Bailey - Executive Vice President and Chief Legal Officer and Corporate Secretary
Conference Call Participants
Ken Cacciatore - Cowen and Company
Marc Goodman - SVB Leerink LLC
Chris Schott - JP Morgan
Liav Abraham - Citigroup
Jason Gerberry - Bank of America Merrill Lynch
Umer Raffat - Evercore ISI
Ronny Gal - Bernstein & Co., LLC
David Maris - Wells Fargo Securities
Vamil Divan - Credit Suisse AG
Good morning. My name is Jacqueline. I will be your conference operator today. At this time, I would like to welcome everyone to the Allergan Q1 2019 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]
Thank you. Manisha Narasimhan. You may begin your conference.
Thank you, Jacqueline. And good morning, everyone. I would like to welcome you to the Allergan first quarter 2019 earnings conference call.
Earlier this morning, we issued a press release reporting Allergan earnings for the quarter ended March 31, 2019. The press release and our Slide deck, which we are presenting this morning, are available on our corporate website at allergan.com.
We are conducting a live webcast of this call, a replay of which will be available on our website after its conclusion. Please note that today's call is copyrighted material of Allergan and cannot be rebroadcast without the expressed written consent.
Turning to Slide 2, I would also like to remind you that, during the course of this call, management will make projections or other forward-looking remarks regarding future events or the future financial performance of the Company. It's important to note that such statements and events are Forward-Looking Statements and reflect our current perspective of the business trends and information as of today's date.
Actual results may differ materially from current expectations and projections depending on a number of factors affecting the Allergan business. These factors are detailed in our periodic public filings with the Securities and Exchange Commission. Allergan disclaims any intent or obligation to update these forward-looking statements except as expressly required by the law.
During the call, we will refer to non-GAAP figures. Our GAAP financial metrics and reconciliation from GAAP to non-GAAP metrics can be found in our earnings release issued this morning and posted on our website. In addition, all global and international growth rates referenced this morning are on an ex-FX basis.
Turning to Slide 3 and our agenda this morning. With us on today's call are Brent Saunders, Chairman and CEO; Bill Meury, Chief Commercial Officer; David Nicholson, Chief R&D Officer; and Matt Walsh, Chief Financial Officer. Also on the call and available during the Q&A is Bob Bailey, our Chief Legal Officer.
With that, I will turn the call over to Brent.
Thank you, Manisha. Good morning and thank you for joining us on our call today. Our first quarter results reflected ongoing strength of our core business across our four key therapeutic areas Medical Aesthetics, Eye Care, CNS and GI.
This represented the 9th consecutive quarter of core business growth. The growth prospects of these businesses remained strong, driven by product line depth, new product flow, commercial expertise, and a robust pipeline with five potential FDA approvals and new product launches anticipated over the next 18 months.
As a management team and Board, we are focused on strengthening and growing our business, while executing disciplined capital allocation and returning capital to shareholders. At the same time, we are realistic about the challenges and risks facing the business and the work we need to continue to create value for our shareholders, customers, patients and colleagues.
We understand that we need to continue to earn their trust through our performance commercially, operationally, and in R&D, and we are committed to acting with urgency to do just that.
Now, let me turn to the quarter's results on Slide 5. We had a good start to the year with continued growth of our core business, which was up 4.4% year-over-year. Against a backdrop of continuing product LOEs, our total revenue was stable excluding the impact of foreign exchange.
We made progress on building several important brands, which we expect will be key drivers of long-term growth. There are many standouts in the first quarter, such as BOTOX, JUVEDERM and VRAYLAR, as well some brands which we are working on further bolstering. Bill will address these in greater detail.
In R&D, we believe we are well-positioned with five anticipated FDA approvals over the next 18 months or so. They include cariprazine for bipolar depression where we expect a regulatory decision later this month; ubrogepant for the acute treatment of migraine where we expect a regulatory decision in December; CoolTone, a new muscle toning system as part of CoolSculpting family, which we expect to launch toward the end of the year.
Bimatoprost SR, which is a dropless glaucoma therapy where we plan to make a regulatory submission in the first half of the year; and abicipar for wet age-related macular degeneration where we plan to make a regulatory submission also in the first half of this year.
In the first quarter, we reported top line results from the Phase III rapastinel program and we were deeply disappointed that these studies were not successful. Our commitment to bring new medicines to patients in need remains unchanged and our pipeline supports this commitment.
Across our four key therapeutic areas, we now have 46 programs on the pharmaceutical side and 30 programs on the device side. I'm happy to report that we achieved solid results in the first quarter, while remaining disciplined and shareholder friendly in terms of capital allocation. You will hear more about this from Matt.
Slide 6 provides an overview of the key drivers of our financial results in the first quarter of 2019, and illustrates that our core business, accounting for about 90% of total revenues reached $3.2 billion. This continued strength of our core business, together with our emerging pipeline, positions us well for 2019 and beyond.
Slide 7 provides more focused look at our core business, which is comprised of promoted brands and brands with ongoing exclusivity. The first quarter of 2019 is the ninth consecutive quarter where our core business has delivered consistent year-over-year growth.
Since 2016, our core business has grown by over $3 billion and currently accounts for 90% of our revenues. In 2017, our core business made up 79% of our revenues; and in 2018, it accounted for 87% of our revenues.
Looking ahead, we expect to work our way through the impact of the LOEs, and reach a place where our core business generates almost all of our revenues.
Before I turn the call over to Bill, I wanted to take a moment to comment on the results of our recent annual shareholder meeting and the extensive discussions we, as Allergan's leadership team and Board of Directors, have had with our shareholders in the weeks and months leading up to it.
Let me start by saying that I take seriously the opinion of our shareholders, including David Tepper, we have benefited from the candid and constructive shareholder feedback, and I shared their desire to create more value at Allergan. Our focus and interests are 100% aligned with those of our shareholders.
We have been on this transformation journey for almost three years since the sale of our generics business. Since then, we have worked to grow our key products, add depth and breadth to our pipeline, and build scale to compete in four therapeutic areas.
I share in the disappointment that the value creation has not materialized yet. But when I look at the strength of our core business, the potential of our pipeline and the dedication of our team and Board, I have great confidence that it will.
So, how are we going to do that? First, we will continue to focus on growing our core business and realizing value through the pipeline. That means keeping our teams focused, delivering excellent service to our customers and driving key R&D milestones.
The sense of urgency to create value is high and the Board is actively and continuously reviewing alternative avenues that could unlock value in the near-term. I assure you that the Board, management team and I recognize the urgency and we will take decisive action to drive value-enhancing opportunities.
Now, let me turn the call over to Bill.
Thanks, Brent. Slide 9 is a product level sales analysis for the first quarter ranked in terms of sales growth versus prior year. We had a strong start to the year, posting double-digit growth rates for several of our major products.
Botox Cosmetics, Vraylar, Viibryd, Zenpep, Juvederm, Ozurdex and Lo Loestrin were standouts in the quarter. Other key brands, Natrelle implants, Alloderm and CoolSculpting were down versus prior year, which I will discuss shortly. Overall, our core business performance was solid and we anticipate growth strengthening throughout the year.
At the bottom of the graph, and as expected, total sales growth was impacted by products already facing loss of exclusivity as well as the restated sales decline ahead of anticipated generic competition.
Now, I will touch on our key therapeutic areas, starting with our largest Medical Aesthetics. Globally, sales for our facial injectable line, Botox and Juvederm, were up 13% versus prior year. Demand was strong domestically and internationally, and demand was broad based across both the aesthetic dermatology and plastic surgery segments.
Turning to Botox, I will talk about our results, the outlook for the market and our toxin development programs. US Botox sales were up 17% and international up 8%. Sales for Botox in the United States, were powered by a significantly larger consumer activation program, with advertising, digital and PR efforts; an expanded sales force to reach more practices and achieving higher levels of customer service; and a first quarter promotional offer for top customers.
Additionally, we added a quarter of a million people to our Brilliant Distinctions loyalty program in the first quarter, which is the best quarter in the history of the program. We have added one million in the last 12 months for a total of six million members.
This is relevant because 67% of our Botox consumers are BD members and they visit their practices 23% more often and spend 36% more per year than non-members. It's an important asset for customers and for Allergan.
Now, for a few comments about the aesthetics market. The prospects for growth here are excellent. There is both a youth movement and a prevention movement under way and Allergan has launched three digital ventures in partnership with aesthetic practices to attract new consumers including Allergan Data Labs.
Which is a data science and digital marketing group now fully operational in Irvine. They are launching the largest digital marketing campaign ever for Botox on Mother's Day, which we expect will attract tens of thousands of new users and loyalty members.
In terms of competition, it's the reality of a growing market. Aesthetics has never been a one-product market and never will be, but it is an efficient market, which means, in the end, it will likely support three products, not four, five or six.
Our strategy, like that of our customers, is to compete on quality, innovation and customer service, not on price. That is the only sustainable strategy in our view. When it comes to neurotoxins, customers and patients are more outcomes and service sensitive than price sensitive. We are well positioned to defend this business we.
Finally, on the product development front, we are developing one of two types of products, products that either help providers deliver even better aesthetic outcomes or products that attract new consumers.
Right now, we are advancing new indications for Botox, masseter and platysma, a new pre-filled syringe for Botox and three completely novel toxins including a liquid, a rapid-acting short duration and a long-acting, which are in various stages of development.
Turning to Juvederm, fillers have been a step change in aesthetics. They have given providers the ability to volumize, lift and shape. Juvederm is the number one filler in the world. Sales internationally increased 18%, with exceptional performance in Asia-Pacific, Middle East, Africa and Europe. New product launches, including Volux last month in Europe and new consumer programs are fueling demand around the world.
In the US, sales were up 6% versus prior year. We expect sales growth for the year to be higher than the first quarter, which was impacted by strong buying in the prior fourth quarter of 2018. For reference, fourth quarter sales in 2018 were up 14% last year.
Turning to Slide 11, CoolSculpting. Our first quarter sales, of course, were below expectations, off 4% versus prior year due to consumer demand and a reduction in system sales in the United States. We have a lot of work to do in this business in the short-term, especially in the U.S., which I will talk about shortly.
Long-term, the outlook for CoolSculpting is still positive for two reasons. First, we are set up to launch three new CoolSculpting systems in the next two to three years, which will improve outcomes for the procedure and underlying demand.
And, second, we have only scratched the surface of the body contouring market with an estimated penetration rate of less than 10%. There is still a large untapped pool of consumers to reach and convert and we expect sales for the year to be up 5% to 10% globally despite our first quarter performance.
We had several priorities when we acquired CoolSculpting. They were expand the US installed base, which is now 50% larger than it was two years ago; reorganize the international business; accelerate the development of new CoolSculpting technologies and drive consumer demand.
In roughly two years, we have achieved three of the four. Right now, more focus is needed on consumer marketing and activation. We have exceptionally high awareness levels. We have 7 million consumers visiting our website, an install base totaling 4,000 accounts and 6,000 systems.
So, the foundation here is solid, but our consumer conversion rate is low. We are taking a number of measures to fix that, including Allergan Data Labs is launching a new digital initiative to drive website traffic conversion with the first-ever free cycle promotion.
We are also partnering with high-end health clubs around the country and conducting marketing events at luxury malls and wellness centers to move consumers from awareness to usage. We are changing the approach here from a focus on not only practices and systems, but also consumers.
Two other important sources of future growth for this business in 2019 are International and CoolTone. In International, we have restructured the business, transitioning from a distributor model to a direct promotion model. We are now doing business directly in 69 countries and have 3,000 systems placed around the world.
Next, CoolTone will launch in late 2019. This is a muscle toning system that is complementary and will be marketed alongside CoolSculpting. We will be taking orders for CoolTone by midyear and shipping equipment in early Q4.
Now, with any launch, current capital sales slow as providers want to see new package offers -- what new package offers might look like. We expect capital sales to rebound upon the launch of CoolTone.
Allergan sales in the first quarter were impacted by a supply constraint for donor material. The supply situation has stabilized and is expected to improve throughout the year. Sales growth of this business should trade in the mid-single digits.
Sales for our Natrelle line of breast implants have been impacted by regulatory changes related to our textured implants internationally. Our 2019 sales outlook anticipated these changes.
In the US, FDA conducted a public hearing on breast implant safety. David will talk more about this shortly. Note that, in the US, over 90% of our business is smooth implants.
Turning to Slide 12 and CNS. Sales for Botox were at expectations, up 6% for the first quarter. The year-over-year comparison was impacted by the fact that the first quarter of 2019 had two fewer selling days than the first quarter of 2018. Adjusting for quarterly selling days, Botox growth was in the high-single digits.
In terms of the market, the migraine prevention market is 10% to 15% larger than it was a year ago. Our share of new chronic migraine patients is 47%, remains stable. We estimate that only 2% of CGRP patients were switched from Botox and combination use is limited. As we have said before, we expect the growth rate in 2019 will be in the mid to high-single digits.
Sales for Vraylar in Q1 2019 totaled $144 million, up 70%. This product continues to exceed expectations on almost all metrics, including prescribers, prescription levels and formulary coverage rates.
The growth catalyst for Vraylar in 2019 is the anticipated new indication for bipolar depression, which is currently under review at the FDA. Target audience at detailing levels for Vraylar will be almost doubled in May to cover not only psychiatrist, but also primary care physicians.
Turning to Slide 13 on GI. Underlying prescription demand growth for Linzess in the first quarter was in the double digits. This was offset by a lower average selling price and trade buying patterns, resulting in a net revenue gain of 1% versus prior year. Sales for Zenpep were strong, up 19%.
Turning now to Eye Care. Our glaucoma business was impacted by pricing headwinds in the United States and the impact of trade buying patterns internationally. We expect this franchise to be stable for the year. Ozurdex sales increased 10%. Our supply situation has improved significantly, and we expect all markets to be fully restocked in the second quarter.
Restasis prescription demand was relatively stable year-over-year. This was offset by a lower average selling price. Sales orders for Restasis MDPF have been replaced by the Restasis single unit vials as we work through a back order situation, which we expect to resolve by the second half.
Finally, turning to Slide 14, our international sales totaled $802 million, up 1% versus prior year. Excluding the impact of Natrelle implants, sales were up 5.2%. The growth drivers were Juvederm, CoolSculpting, Botox Cosmetic, and Botox Therapeutic.
The Asia-Pacific, Middle East, Africa region continues to be the most important growth driver in our International business. In the quarter, LACAN sales were further impacted by trade buying patterns for our Eye Care business and lower Fibristal sales and generic Restasis in Canada.
With that, I would like to turn the call over to David.
Thank you, Bill. And good morning, everyone. We made significant pipeline progress in the first quarter of the year. Before I talk about progress, I will begin with the readout from our Phase III program of rapastinel as an adjunctive treatment in major depressive disorder. I was very disappointed by these results.
Despite the setback, our commitment to bringing innovative medicines to patients with unmet needs in mental health remains unchanged. We expect to present detailed data from the rapastinel program at an upcoming medical conference.
We still have two studies with rapastinel ongoing. One in suicidality and the other in monotherapy. We will perform an interim analysis of these studies to check for futility, and we will see this data later this year.
Turning to Slide 16, which highlights the major upcoming catalysts for the year. As you heard from Brent, we expect approval of five major programs over the course of the next 18 months. Most near-term is the anticipated approval of cariprazine for bipolar depression where we have an FDA action date later this month. As recently announced, our NDA has been filed for ubrogepant, our oral CGRP inhibitor for the acute treatment of migraine, and we have an action date in December.
Also within CNS, we expect to report in the second half of the year top line results from the ongoing Phase II study of AGN-241751, our oral NMDA modulator. This agent has the same mechanism of action as rapastinel. The oral formulation allows us to evaluate the safety and efficacy of more frequent dosing.
Turning to Eye Care. We recently reported safety data from the MAPLE study for abicipar in neovascular age-related macular degeneration. Data from this study showed a decrease in the rates of inflammation compared to that previously reported in the Phase III CEDAR and SEQUOIA studies.
We view this decrease in inflammation rates a step in the right direction and we will continue to work on improving the formulation. We expect to make a regulatory submission in the US in the first half of the year, followed by a submission in the EU in the second half of the year. We also expect to make a regulatory submission for Bimatoprost sustained release in the US for the treatment of glaucoma in the first half of 2019.
In Medical Aesthetics, we are excited to be launching CoolTone, a muscle toning system utilizing high frequency electromagnetic stimulation aimed at fast-twitch skeletal muscle. In addition, versions 3.0 and 4.0 of CoolSculpting are expected within the next two to three years.
Slide 17 provides a summary of the key events we anticipate over the next 18 months. We continue to advance the rest of our mid to late-stage pipeline according to our targets and expectations.
Turning to Slide 18, our pharmaceutical pipeline has 46 programs in various stages of development, with two that are currently under regulatory review and 10 programs in Phase III development.
Our development programs continue to remain aligned with our timelines with the exception of brazikumab. This IL-23 monoclonal antibody is being developed in a competitive space with a large number of competing trials.
Similarly, as outlined on Slide 19, we continue to develop our device pipeline with 30 programs in development. This will continue to drive innovation within Medical Aesthetics. This is a rich development portfolio in line with our leadership in this area and, as such, we have more than doubled our R&D investments in devices in Medical Aesthetics over the last two years.
In the quarter, the FDA held a two-day advisory committee to discuss the benefits and risk of breast implants and dermal matrices. The agency recently announced that textured breast implants will remain on the market, and are considering actions to be taken to improve product labeling and communication .
We are excited about the future of our R&D organization. As always, I thank my colleagues in R&D for their hard work, as well as the investigators and particularly the patients who are participating in our clinical trials.
And now, I will turn the call over to Matt.
Thank you, David. And looking now to the key financial highlights on Page 21. As Brent mentioned earlier, our core business continues to be strong and we are delivering on our key financial commitments through the first quarter of 2019.
Starting at the top of the Page, net revenues in the quarter were $3.6 billion, flat year-over-year on a constant-currency basis, which means the 2% decline in reported revenues was due solely to foreign exchange translation.
The highlight of the quarter was the solid performance of the promoted brands with ongoing exclusivity, which was up 5.3%. This entirely offset the 27% decline in LOEs and divestitures, which now includes the generic entry of Canasa.
Our core business, which comprises 90% of total revenues, grew 4.4% at constant currency and was actually over one percentage point higher at 5.5% excluding the impact of regulatory changes in the international textured implant market.
A few things to bear in mind as we think about 2019 revenues. First, from a phasing perspective, our first quarter tends to be our seasonally slowest quarter revenue-wise historically. And second, as we stated when we issued 2019 guidance, we expect revenue growth rates to accelerate in the remaining quarters of 2019 as we annualize the back half 2018 issues related to the Ozurdex recall and Alloderm donor supply.
Now, turning to margins. Non-GAAP gross margin grew 50 basis points to 86.7%, primarily driven by favorable product mix. Operating margins, however, declined 270 basis points to 45.2%, which was driven by two key factors.
First, in sales and marketing, we increased expenditures in our Facial Aesthetics business and we bolstered our commercial footprint internationally, especially in Asia Pacific. And second, we increased R&D spending to support ongoing late-stage clinical development programs.
Turning to the lower section of the Slide. Non-GAAP performance net income per share was $3.79, representing a 1% growth year-on-year versus the first quarter 2018, which reflects the impact of share buybacks during 2018 in the first quarter of this year.
Slide 22 provides an overview of our P&L line items for the quarter, most of which I have already discussed. I would, however, like to highlight two important line items, our net interest expense and our tax rate, both of which are meaningfully favorable to prior year, and this was contemplated in our 2019 guidance.
I would now like to discuss a significant GAAP accounting matter and provide the appropriate context. Each quarter, we monitor goodwill and intangibles for indicators of impairment.
In the first quarter, we recorded a $2.5 billion goodwill impairment in our General Medicines reporting unit, primarily related to the failure of rapastinel in Phase III clinical trials and, to a lesser extent, timing true-ups of other R&D programs.
Bear in mind that this goodwill impairment in our Gen Med reporting unit is not related to the acquisition price of Naurex as this was 100% expensed, this IP R&D, at the time of the acquisition in 2015.
Rather, this impairment is a consequence of the removal of future anticipated cash flows related to rapastinel and the timing true-ups of other programs from our long-term financial projections. This in turn lowered the fair value of the Gen Med reporting unit as of March 31 below book value.
While the strong performance we have seen across other parts of Allergan support increased fair values, those increases are in other reporting units which, under GAAP, do not impact the goodwill impairment test of the Gen Med business.
Turning to Slide 23 now and returning to the quarter's results, here we see an overview of our financial results by reporting segment. US Specialized Therapeutics experienced a decline of 2.3% in revenues, which was driven by lower Restasis sales, as well as the sale of our Med Derm business in 2018. Contribution margin was down 290 basis points, driven by the revenue decline, coupled with the increase in promotional spending in our facial aesthetics business.
Looking at U.S. General Medicine, the segment grew 2.1% year-over-year. This was driven by double-digit growth across key brands, including Vraylar, Viibryd, Lo Loestrin and Zenpep. This growth was offset by the continued impact of products facing LOEs, which in this quarter also includes the generic entry of Canasa.
Contribution margin increased 90 basis points due to higher revenues and the benefit from lower promotional selling expenses, resulting from the restructuring initiatives. Lastly, on international revenues, these grew 1% on a constant currency basis and was significantly impacted by foreign exchange translation.
On a constant currency basis and excluding the impact of the regulatory changes in the textured Implant market, international revenues increased 5.2% year-over-year. Contribution margin declined 40 basis points, due in part to the textured implant issue as well as increased investment into high-growth regions, especially Asia-Pacific.
Now, turning to Slide 24, you can see our operating cash flow in the first quarter was strong at $1.2 billion and this supports our 2019 guidance of $5 billion to $5.5 billion. Our priorities on capital allocation remain unchanged.
First, reinvestment in our business for growth in our four key therapeutic areas. During the quarter, we acquired Envy Medical, which increases the breadth of our Medical Aesthetics offerings to now include skin resurfacing and dermal infusion.
Second, debt reduction, which is important in the context of the anticipated Restasis LOE. Third, funding and prudently growing our dividend. And fourth, share buybacks as a means to manage earnings dilution that would result from asset sales or from long-term equity-based incentive plans.
And as you can see on our capitalization table, we continue to work toward our capital allocation goals. We ended the quarter with $23.5 billion in total debt and $1.8 billion in cash and equivalents, which brings our net debt to adjusted EBITDA ratio to 2.8 times as of March 31.
Coming up in the second quarter, we have a scheduled debt maturity of approximately $800 million and we intend to retire using cash on hand and operating cash flow. We remain committed and on track to achieve our target net leverage ratio of 2.5 times by the end of 2020, which would, of course, enable us to sustain our commitment to an investment-grade credit rating.
With regard to share buybacks, we said on the last call that, as part of our 2019 guidance, we intended to repurchase $800 million of shares during the year. We accomplished this entire amount in the first quarter, which completely utilizes the 2018 $2 billion share repurchase authorization.
We have the 2019 $2 billion share authorization available to us. However, it's important to note that our revised guidance contemplates no further share repurchases during 2019. As previously mentioned, this assumption may change depending upon the progression of asset sales.
Moving now to guidance on Page 25, we are revising guidance upward for 2019. Starting with net revenues, we are raising our full-year outlook and now expect 2019 net revenues to be between $15.1 billion and $15.4 billion, $100 million higher on the low and high end from the previously provided guidance of $15 billion to $15.3 billion.
We now assume a mid-May LOE for Restasis and the increase in revenue guidance is driven by the additional Restasis exclusivity. Our updated revenue guidance continues to contemplate strength in the core business, which is expected to grow at a rate similar to last year in the mid to high single-digit range.
Additionally, we continue to incorporate headwinds previously discussed related to Ozurdex, textured implants, industry wide pricing pressure and foreign exchange translation, and we believe our revised guidance is appropriately conservative across all these points. We continue to expect non-GAAP gross margins for the full-year to be 85% to 85.5% based on our product mix and LOE assumptions, including the impact of generic Restasis.
Our non-GAAP SG&A and R&D expense remains unchanged, as we continue to invest in growth drivers for our key businesses and in advancing our clinical programs in development. Should there be a sustained benefit of incremental Restasis revenues versus our expectations, we would look at opportunities to reinvest a portion of these proceeds back into the business. And this would be similar to what we executed in 2018.
Besides revenue, the only other guidance item that is changing is performance net income per share, which we are increasing from greater than or equal to $16.36 to greater than $16.55. As with revenue, this increase reflects the assumption of additional Restasis exclusivity to mid-May on top of solid core business performance, which is soundly in line with our expectations at this point.
For reference, each additional month of Restasis exclusivity is estimated to add an incremental $60 million to $70 million in sales. Also, please note that our guidance does not include the impact of any significant asset divestitures. If or when we complete these, we will provide an update on the impact to our key financial metrics, including non-GAAP performance income per share.
Until such time as there is a generic Restasis, we expect to provide quarterly financial guidance, both top and bottom line. With our seasonally slowest quarter of the year in Q1 now behind us, we are forecasting sequentially stronger top line performance for the remainder of the year.
For the second quarter 2019, we expect total reported net revenue between $3.85 billion and $4 billion and non-GAAP performance net income per share between $4.20 and $4.40.
And with that , I will turn the call back to Brent.
Thank you, Matt. As reflected in our first quarter results, we had a solid start to the year. We are seeing continued momentum in the core business, progressing our pipeline and excited about the launches that we have ahead and, certainly, remain confident in the targets we have for the remainder of the year.
We have covered a lot today. So, let's maybe start the Q&A and I will ask Jacqueline to open the line for questions.
Certainly. [Operator Instructions] Your first question comes from Ken Cacciatore from Cowen & Company. Your line is open.
Hey, good morning, Good morning. Brett, question for you, you mentioned in your prepared remarks that you talked about the recent shareholder vote that you and the Board continue to look at alternative avenues to unlock value.
So, my question is what would push you and the Board to take these alternative avenues. Is there a certain metric or is it just non-performing share price? Can you give us a sense of what would prompt maybe a different turn into than what you are doing?
And then, along those same lines, what are you hearing as you speak to your shareholders? Is there a common theme that you could discuss with us? Maybe a common frustration they point to and how do you address it? Thank you.
Yes. Thanks, Ken. So, look, let me answer your questions perhaps in reverse order if that is acceptable. In terms of the shareholder engagement, both the management team and our Board did, which was significant over the last few months, I think there is a common theme from our shareholders, which is a frustration in the performance of the stock price.
Let me be clear. I share that frustration. I understand that frustration. I'm a very large shareholder relative to my own personal holdings in Allergan and most of the management team is likewise situated. And so, that is something that was loud and clear and we need to make sure that we do everything we can to unlock value and create a better shareholder return for our shareholders over the long-term.
And so, that is clearly, I think, the top issue we heard and we heard it loud and clear. And our Board heard it loud and clear. And I think that was a very constructive and positive experience for our Board members to hear from probably close to 50 different shareholders that they engaged with. So, I think that is pretty straightforward.
I think in terms of prompting us to do something different, the way I would come at it, I would say it's multi-factorial. We have a very experienced and engaged Board. We also have a refreshed Board with several new members with lots of different experiences in this industry and in other businesses.
And I would say that given the frustration on shareholder return, given the strength of the core business, given the pipeline that we have and then put that in the context of the operating environment, the political environment, the regulatory environment, the global environment, we continue to look at what are the ways that we can unlock value.
And I would say that is something that we do regularly and continuously and now, I would say, with a sense of urgency. And so, the Board is on it. The Board is engaged. And stay tuned.
Okay. Thank you.
Your next question comes from Marc Goodman from SVB Leerink. Your line is open.
Yes. Morning. David, can you talk about what do you think happened with rapastinel? And talk about the oral pill 751 and whether we should still feel confident are you still confident that that can work?
And then, separately, can you just talk about the breast aesthetics outlook and just review with us how you all are thinking about this now? We have a panel that seem to be not so dire. We have a commentary from the FDA. It doesn't look like it's that big a deal. What is going on in Europe? Just give us a sense of how we should be thinking about that business now. Thanks.
Yes. Thanks, Mark. So, regarding rapastinel and 241751, and I can make a few comments about breast implants and perhaps Bill from a commercial perspective. We will talk about that mainly. So, look, with Rapastinel, we have the positive Phase II study and then we performed the Phase III programs in adjunctive MDD using once-a-week dosing. And we know that, with ketamine, another NMDA receptor modulator, that such a regimen can be effective in depression.
Now, clearly, when we look at animal models of depression or psychiatric disorders, rapastinel and 751 are incredibly effective in those models. Having said that, some very recent data has shown the more frequent the dosing in those animal models, the greater the efficacy. And that holds true both for rapastinel and for AGN-241751.
But, clearly, I don't know the answer yet. But with 241751, because it's an oral compound, we can test and are testing more frequent dosing. So, by analogy, with the animal data, that may give us a greater chance of showing efficacy with this mechanism of action because 751 has the same mechanism as rapastinel and we plan to have data with 751 by the end of 2019.
Yes. Regarding breast implants, I was present at the advisory, the two day advisory committee that the FDA held recently. And recently, the FDA told us that based on that advisory committee and their other analysis that the textured breast implants, which was the main topic of discussion there, will remain on the market, although they are going to discuss labeling and enhancing communication with the various manufacturers.
Of course, majority of implants that are used in the U.S. are, in fact, smooth implants. There will be a discussion with the FDA about dermal matrices, but that is a different topic. Of course, conversations around the world about taking place with various regulatory authorities about textured implants, and perhaps Bill could pick it up from here.
Yes, Mark. I think the hearing that the FDA held in Washington was very constructive. As you know, they heard from patients and surgeons and companies. The actions that they are contemplating relate to labeling, informed patient consent, as well as data reporting and collection. And I think all of those things are appropriate right now.
As a commercial matter, 70% of the sales for our Natrelle implants are in the United States, 30% are International. For the purposes of projections, the International business has been appropriately adjusted for our 2019 outlook and beyond.
And as it relates to sales, in the United States, even in the context of the actions FDA is contemplating, I expect that to be a stable business. I think, there was a lot of coordination between the companies and the plastic surgeons to make sure that women's safety is the number one priority here, and I think the business will be stable as we move forward.
Okay. Next question, Jacqueline.
Your next question comes from Chris Schott from JP Morgan. Your line is open.
Great. Thanks very much for the question. I was just hoping you could elaborate a little bit more on the CoolSculpting dynamics. I guess, specifically, what in your view triggered this lower consumer uptake or conversion and what gives you confidence that you can fairly quickly turn this around to be able to grow the business this year?
And, If I could, just one follow-up to Ken's question. Brent, I know you've been asked about the idea of a breakup of the company on and off for what seems like the past few years. And I'm sure you are pretty sick of answering it.
But, I guess, given the sustained valuation discount, do you further reconsider some form of split in the company if we don't see a recovery in the share price? And that is a question we constantly are getting from investors. I would just love to hear your latest thoughts on it. Thanks so much.
Yes. So, maybe let me answer the second part and then Bill can talk about CoolSculpting. So, look, you are exactly right, Chris. I do get the question quite a bit around split. In fact, I think I very publicly and very clearly addressed this at a Leerink conference a couple of months ago.
And let me just reiterate what I said there, which still holds true, is I have always remained open-minded and the Board remains open-minded to that idea if we believe it's something that creates long-term value.
There are number of factors that go into looking at that one. You just said which is the sustained valuation discount is something that is clearly important. We also tend to look at some of the other important issues, which I mentioned at Leerink and at many other times, like scale particularly outside the U.S. and that is something that is improving as that business grows.
We clearly need to protect Botox as a brand, which is both a aesthetic and therapeutic product and one of the most important brands in the Allergan family. So, that is something that we would have to clearly be thoughtful and meticulous in terms of how we thought about that.
And then scale of R&D as the science of medical aesthetics is clearly moving in the direction of biopharmaceutical R&D versus just medical device R&D. And so, those are just a few of the things that we tend to look at outside of financial complexities and other things like that. But, look, everything is on the table. I said everything was on the table.
Our Board will regularly and actively evaluate these types of decisions. And I think I also made clear in my answer to Ken, they are going to do that with a sense of urgency. So, stay tuned and we will see where we go.
Hi, Chris. As it relates to CoolSculpting, first, this is getting a lot of attention right now, as you can imagine, I will tell you that the problem we are facing is not due to market saturation, it's not due to customer satisfaction and it's not due to competition, right? I think that is important to recognize. We are managing, I think, two issues in addition to my earlier remarks.
The first one is, when we acquired Zeltiq, we knew that we had what I would describe as an innovation for a new product cycle gap when we got into this 2018 to 2019 period, In other words, if you go back between 2013 and 2017, over a five-year period, there were six different applicators launched for CoolSculpting.
And each applicator opened up a different area of the body and sustained a pretty robust growth rate over that period. It's been fairly quiet for the past 18 to 24 months, and I think we have fixed that right now. We are going to launch CoolTone at the end of 2019, and then we are set up for two additional system upgrades over the next two to three years. Think iPhone 8, 9 and 10.
The second issue is that, after several years on the market, we are dealing, to be fair, with a different type of consumer. We have essentially got to all of the early adopters and now we are working on a group of late adopters.
And they have more questions and they are somewhat more cautious. And so, we have really shifted our focus from, as I mentioned, practices and system placements to a more consumer model. I think the outlook for the business, it's still very positive. You have to recognize that CoolSculpting has a long runway.
And if we are successful with CoolTone, next generation CoolSculpting, and then with our skin tightening technology over the next, let's call it, two to three years, and we are successful both domestically, internationally, this business should reach our initial expectations or come very close.
Next question, Jacqueline.
Thank you. [Operator Instructions] Your next question comes from Liav Abraham from Citi. Your line is open.
Good morning. First, Brent, I would be interested in how you are thinking about deal making and augmenting your pipeline, particularly on the pharma side as programs either mature or sale, it's been pretty quiet on that front for the past year, at least. I would be interested in your commitment to your open science approach as opposed to potentially enhancing your internal research capabilities. And then, secondly, perhaps for Bill, I would be interested in your view on the pricing outlook for the toxin franchise in 2019 and beyond, given an additional entrant into the market. Thank you.
Yes. Thanks, Liav. So, look, let me start by saying that R&D and innovation is the lifeblood of Allergan as it is for any biopharmaceutical company. It's important for us. And I think Bill just kind of explained it in the context of CoolSculpting to have continuous innovation to drive growth. That holds true across the entire portfolio.
When we look at the therapeutic side of our business, which is important, clearly, we are focused on four therapeutic approvals and launches over the next 18 months that are really important for us, whether that be bipolar depression for Vraylar, ubrogepant, abicipar, Bimatoprost SR but, as David mentioned, we also have 10 Phase III programs continuing to advance, whether that be relamorelin or brazikumab or a variety of other things that are listed on the chart in the presentation.
I think when we look in the earlier pipeline, we absolutely need to continue to look to enhance and increase our opportunities to bring real innovation to patients. Some of that will come through some of the collaborations we have already established. So, for example, we have an IND that was accepted or approved related to our partnership with Editas for Leber disease and we expect to enroll patients later this year.
Our first IND with the microbiome and our assembly was also approved, and we will start to enroll patients as well. We are enrolling patients already in that one and we have a variety of other partnerships like that as well that will continue to throw off development candidates. So, there are a lot of activity and we constantly look for new science and new partnerships and new collaborations.
And, in fact, to the second part of your question, upgrading skills is a continuous process. We are always looking to enhance our capabilities in R&D and in science. And, in fact, we announced last quarter or right around the JP Morgan Conference.
I believe, that we were opening up our office in Boston and moving our head of external science and innovation to Boston and building out and hiring and recruiting in the Kendall Square area new science and scientists and capabilities. And so, that is actively under way and we believe that is the right place to have an additional office for our R&D organization.
Now, we are in Southern California, we are in South San Francisco, we are in New Jersey, we are in the UK, and we are in Boston, as well as a few other places. And so, I think we have got a good spread and we are committed to recruiting the best scientists and the best minds that we can to supplement our thinking.
You want to talk, Bill?
I think that as it relates the aesthetics market and pricing, I think it's a good question. This market has and I think will continue to trade on innovation and customer service. As you know, it's on a very, very solid growth trajectory. It's hard to predict what some of the other companies might do.
I would just say that I think price discounting is tempting, but it can be a trap long-term. It's a slippery slope. It lessens the perceived value of a product. It cuts in the profits, cuts in the customer service, cuts in the R&D. The way we think about it is the value of our products and services right now exceed the prices that we charge.
And if we don't believe that at some point in the future, we make an adjustment. I think the focus here has got to be on attracting new users to the category and introducing products that improve outcomes for those consumers. And that is where we stand right now. I think the business is in great shape as we head into the next several quarters of 2019.
Great. Jacqueline, next question.
Your next question comes from Jason Gerberry from Allergan. Your line is open.
I don't think I work for Allergan. But, hey, Jason Gerberry from Bank of America. Hey, guys. Can you just comment - I know you commented on about 2019, but just sort of curious , your 5% revenue CAGR and how that stands in the aftermath of the rapastinel failure and the MAPLE trial, the tolerability perhaps not hitting the target of some of your competitors on the market. So, can you talk a little bit about, in lieu of those things, are there some positive offsets that have occurred in your mind that could pick up the slack there to show overall level of confidence in the 5% revenue CAGR would be great. Thanks.
Yes, absolutely. And if you are looking for a job at Allergan, give me a call later, but [indiscernible] employment. Thanks, Jason.
Look, yes, we are absolutely committed to the 5%. I think some reasons to feel confident about that are the nine consecutive quarters of core business growth, which is now 90% of Allergan and I think will ultimately become most of Allergan over time.
Areas like facial injectables that grew 13% this quarter, looking at products like Vraylar and even Zenpep and Viibryd that are growing above expectations. We saw Lo LOESTRIN and Ozurdex strong at roughly 10% or better year-over-year. And so, those are reasons to be confident in that core business.
Clearly, as we look at the back part of that guidance, the pipeline needs to participate to enable us to reach that target. And rapastinel was frankly not a big part of that guidance. It was further out. So, it really doesn't impact our thinking there.
Esmya did and we have already incorporated that into our thinking. But we have seen improvements in other parts of the, the pipeline, right? So, they were all risk adjusted when we made the comment. We know that the profile of ubrogepant looks very positive and the risk benefit there looks very positive.
Obviously, we need an FDA approval, but that looks good. Bim SR had surprisingly positive results as well and that is being filed in the first half of this year. Abicipar is the only true 12-week anti-VEGF. While we are improving the inflammation, we still believe that could be a very nice product in the forecast, and so that is moving forward.
International growth continues to look solid and will be a big contributor. And so, bear in mind, our outlook was adjusted for some of the asset sales, and so we continue to exceed expectations in the delivery of our quarters. And I think all those reasons combined, both positive and negative, give us reason to be confident.
Great, thank you.
Your next question comes from Umer Raffat from Evercore. Your line is open.
Hi. Thanks so much for taking my question. Brent, you said everything's on the table and Board is evaluating decisions. My question is, what are your and what are Board's thoughts on the types of valuations some non-pharma spins are getting from the market, for example, Alcon. And what is the timing of when we can hear something from the Board?
And then, one for David as well , if I may. David, from AAN, we saw ubrogepant safety data presented yesterday. And there were five cases of rhabdomyolysis mentioned in there, of which four happened at the higher dose. My question to you is, this wasn't broken out in a proper safety table, but it was more like in patient history comments. So, the question is, how was that term rhabdomyolysis defined in those patient histories. Was it just CK elevation or was it CK elevation plus organ manifestations? Thank you.
Yes. So, thanks for the questions. Umer. I will address your first one. And it really I think was answered in Chris' question as well, which is, look, we look at everything. And, clearly, when you see the sustained valuation disconnect, I told you we also evaluate how the market is evaluating and valuing other comparable alternatives.
Alcon would be one of those inputs that clearly we would look at as one of many models to evaluate these types of decisions. We also have new Board members with different experiences and we have a Board that just was out talking independently to 50 plus shareholders. And they heard the sense of frustration.
So, our Board has regularly and continuously evaluated the strategy of this company. They are actively engaged in those discussions and they feel a sense of urgency. I'm not going to put a timeline on that, but I will be very clear again. Our Board gets it. They heard it directly from our shareholders and there will be a sense of urgency.
David, you want to answer?
Yes. the rhabdo question. Thanks, Umer. Yes, interestingly, just general comment first, we increasingly see cases of exercise-induced rhabdomyolysis in our Phase I studies these days across the Board, across multiple projects. I personally believe that is because people are doing more intense workouts these days. And when I discuss with my colleagues, heads of R&D from the pharmaceutical companies, they see it as well.
Now, back to ubrogepant, the cases are primarily diagnosed based on creatine phosphokinase release from skeletal muscle plus patient history discussions. When we are talking about the incidence of rhabdomyolysis in the ubrogepant studies, you've got to look at -- of course, at the totality of evidence.
And we do see cases of exercise-induced rhabdomyolysis in placebo standard of care cases, as well as in the ubrogepant arms, case rates differing in arms between studies. But across the whole ubrogepant database, the rates were 0.2% in placebo standard of care treated individuals and 0.2% in ubrogepant treated individuals.
Your next question comes from Ronny Gal from Bernstein. Your line is open.
Good morning. I'm going to skip here the discussion about the company breakup, given I think we exhausted that. So, I have got two for Bill. Bill, CoolSculpting, I understand the argument you are making around what we are going to push the product. I guess, the question is, is this part of delivering the expected results from patients who are already using it. And I was wondering if you might have some data about attrition rate, and especially in comparison to attrition rates on fillers or on Botox. That is, are we seeing the same kind of repeat use rate from even the early adopters of CoolSculpting as we see from the more established products where benefit is established.
And second, back to the General Medicine business, it seems that the pricing you are obtaining and just looking year-over-year for the Eye Care product, for the IBD products, are a little bit lower than they were in 1Q 2018. And just talking to the peers, it seems like it's more of an effort to go ahead and press down some of those older category for discount. So, when we think about kind of like the pricing you obtain from those areas of older products going forward, should we assume kind of the small negative number in terms of pricing over the year or should we still expect [indiscernible] to slightly up?
Okay, thanks. Ronny. As it relates to CoolSculpting, I think consumer satisfaction with the procedure is high. A couple of points about that. If you take a look at RealSelf and you look at the Worth It rating for CoolSculpting, it's roughly 78%. Now that trades a little bit lower than a facial injectable, but that is not surprising for a body contouring procedure.
Satisfaction levels will trade lower if a patient does not receive an adequate number of treatment cycles. Right now, that number is at roughly five. Ideally, if you talk to most plastic surgeons, it should be six to eight. And so, with adequate treatments in a given area of the body, the satisfaction for CoolSculpting is right where it has been and where we expect it to be.
As it relates to repeat visits, there isn't a reoccurring revenue stream. In other words, once someone receives their six to eight cycles for a given problem area, then it's, in many respects, a permanent solution. And so, I think that deals with the CoolSculpting question.
I would also say that when you take a look CoolTone and the next generation CoolSculpting system, as well as the skin tightening solution, each one of those should enable plastic surgeons and derms and other product providers to improve outcomes for patients.
As it relates to the General Medicine business, I think you have it right, I think about price, whether it be for Linzess or for Restasis or for our US glaucoma business, as being neutral and there could be some downward pressure on it. I think that is the reality of the healthcare system right now.
I think the positive in all this for us is that prescription demand for these businesses - obviously, Linzess is very solid and the product is on the market for seven years now and prescriptions were up 10% and units were up 14%. As it relates to the more established businesses like Restasis or glaucoma, demand is relatively stable. And so, you will see a little bit more price pressure read through to the sales line on those businesses. But I think your outlook is right.
In the interest of time, we will take two more questions, please.
[Operator Instructions] Your next question comes from David Maris from Wells Fargo.
Good morning. If you could just remind us where you are on the marketing push that you had mentioned in the Aesthetics Day that you are going to put, I think, it was $150 million in DTC. Are we in the early stages of that or is it front-end loaded this year? And any sort of either engagement metrics or patient acquisition cost metrics, even trend-wise that you are seeing and early feedback, that would be great.
Yes, I would say, the program that we described at Medical Aesthetics Day is up and running. I think we are starting to see very, very solid results. In fact, the Botox Cosmetic growth rate in the first quarter of 17%, while part of that was due to a one-time promotional offer, the underlying demand for the product in the quarter was in the double-digits.
I mentioned in my remarks, Brilliant Distinctions is a real asset for us. I would describe it as a note around Botox. We added 250,000 members in one quarter, which is the best quarter we have had in the history of the program.
The digital ventures spotlight, which is an online destination for all things beauty, we had 1.5 million visitors to it in the first year. That number will approach 2 million very, very shortly. We are running a Mother's Day promotion, which I mentioned, and there was a sign-up opportunity for a sweepstakes.
I won't get into the details, but we had roughly 50,000 women sign up in roughly a week. And so, I think all of the digital and consumer advertising work that we are doing is attracting new consumers into practices for plastic surgeons and dermatologists, which is ultimately what our aim is.
Jacqueline, next question, please.
Your last question will be from Vamil Divan from Credit Suisse. Your line is open.
Great. Thanks for getting me in and taking my questions. So, maybe I will sneak in two, if I'm last. So , just one on your guidance, you beat your guidance for the quarter pretty handily on performance net income per share. Your guidance for next quarters, second quarter is higher than where consensus is.
But your full-year actually went up by a little less than what you beat by. So, I'm just trying, get a sense, is there anything you are seeing in the models as it relates to the second half of the year, that maybe needs to come down or something or is this maybe just a little bit of conservatism as you think about the back half of the year?
And then, the second one, maybe just a cleanup, I think for a long time that is been talked about, Botox Therapeutic opportunities in depression, afib and others. I'm not really seeing that in your slides anymore. I'm just wondering if there is any work that is still going on for other therapeutic opportunities. Thanks.
Matt, you want to take the first part of the question on guidance?
Yes, sure. So, you actually answered the question, Vamil, when you said it's really related to timing. It's a little bit early in the year to be calling up of the full-year. Right now, to this point, the business is progressing well. It's progressing according to our expectations, but it's just a little bit soon to be calling it up and we will revisit this shortly when we issue second quarter results.
David, you want to touch on Botox Therapeutic development?
Yes. Thanks, Brent. Happy to do that. Yes, thanks for the question. And, of course, we are continuing to develop multiple opportunities for Botox and our related toxins. Bill, in his comments, mentioned the fact that we have multiple toxins in development.
We are looking at different ones for different opportunities regarding specifically therapeutic uses. Yes, we are planning to continue the development of a toxin in depression and we are also in Phase II trial with a toxin in atrial fibrillation following open-heart surgery. So, yes, those trials continue, the development continues.
Well thank you. This concludes our call. I would like to just end by thanking our colleagues around the world for delivering a solid quarter and staying focused on our customers and patients and making sure that we deliver on our commitments. We look forward to keeping you updated. And we will be in touch soon. Thank you.
This concludes today's conference call. You may now disconnect.