Edited Transcript of VRTX earnings conference call or presentation 30-Jan-20 9:30pm GMT – Yahoo Finance

Q4 2019 Vertex Pharmaceuticals Inc Earnings Call

Cambridge Feb 4, 2020 (Thomson StreetEvents) -- Edited Transcript of Vertex Pharmaceuticals Inc earnings conference call or presentation Thursday, January 30, 2020 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Charles F. Wagner

Vertex Pharmaceuticals Incorporated - Executive VP & CFO

* Jeffrey Marc Leiden

Vertex Pharmaceuticals Incorporated - Chairman, CEO & President

* Michael Partridge

Vertex Pharmaceuticals Incorporated - SVP of IR

* Reshma Kewalramani

Vertex Pharmaceuticals Incorporated - Chief Medical Officer

* Stuart A. Arbuckle

Vertex Pharmaceuticals Incorporated - Executive VP & Chief Commercial Officer

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Conference Call Participants

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* Alethia Rene Young

Cantor Fitzgerald & Co., Research Division - Head of Healthcare Research

* Brian Corey Abrahams

RBC Capital Markets, Research Division - Senior Biotechnology Analyst

* Cory William Kasimov

JP Morgan Chase & Co, Research Division - Senior Biotechnology Analyst

* Konstantinos Biliouris

Morgan Stanley, Research Division - Research Associate

* Liisa Ann Bayko

JMP Securities LLC, Research Division - MD and Senior Research Analyst

* Michael Jonathan Yee

Jefferies LLC, Research Division - Equity Analyst

* Paul Andrew Matteis

Stifel, Nicolaus & Company, Incorporated, Research Division - Co-Head of the Biotech Team, MD & Senior Analyst

* Philip M. Nadeau

Cowen and Company, LLC, Research Division - MD & Senior Research Analyst

* Robyn Kay Shelton Karnauskas

SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst

* Salveen Jaswal Richter

Goldman Sachs Group Inc., Research Division - VP

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* Whitney Glad Ijem

Guggenheim Securities, LLC, Research Division - Senior Analyst of Biotechnology

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Presentation

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Michael Partridge, Vertex Pharmaceuticals Incorporated - SVP of IR [1]

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Good evening. Welcome to the Vertex Full Year and Fourth Quarter 2019 Financial Results Conference Call. This is Michael Partridge, Senior Vice President of Investor Relations for Vertex. Making prepared remarks on the call tonight, we have Dr. Jeff Leiden, Chairman and CEO; Dr. Reshma Kewalramani, Chief Medical Officer; Stuart Arbuckle, Chief Commercial Officer; and Charlie Wagner, Chief Financial Officer. We recommend that you access the webcast slides on our website as you listen to this call. This conference call is being recorded, and a replay will be available on our website.

We will make forward-looking statements on this call that are subject to the risks and uncertainties discussed in detail in today's press release and our filings with the Securities and Exchange Commission. These statements, including, without limitation, those regarding Vertex's marketed CF medicines, our pipeline and Vertex's future financial performance are based on management's current assumptions. Actual outcomes and events could differ materially.

I will now turn the call over to Dr. Jeff Leiden.

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Jeffrey Marc Leiden, Vertex Pharmaceuticals Incorporated - Chairman, CEO & President [2]

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Thanks, Michael. Good evening, everyone. We saw many investors and analysts at the JPMorgan Conference 2 weeks ago. So I'll spend just a few moments highlighting our 2019 achievements in what we believe sets Vertex apart for the future.

2019 was a truly remarkable year for Vertex. All parts of our business met or exceeded the goals we set at the start of the year. And as a result, we are very well positioned to bring our CF medicines to many more people and to advance our broad pipeline in additional diseases in 2020.

In cystic fibrosis, the U.S. approval of TRIKAFTA for patients 12 and older in October, 5 months ahead of our PDUFA date, was the most significant milestone to date in our efforts to bring new CF medicines to all people with this disease. TRIKAFTA is a remarkable medicine that holds the potential to treat up to 90% of all people with CF. As you'll hear from Stuart, the U.S. launch of TRIKAFTA in patient ages 12 and older is off to a very strong start. There's clear interest in TRIKAFTA across all groups of eligible patients, and the early feedback from both patients and doctors is highly positive.

Outside the U.S., in 2019, we reached a number of key reimbursement agreements for our CF medicines that will allow many thousands of new patients to begin treatment with our CFTR modulators in countries, including England, France, Spain, Australia and many others throughout 2020.

We're also making excellent progress advancing and broadening our pipeline beyond CF. As we enter 2020, we are now in the clinic with multiple new medicines in 5 diseases outside of CF. We continue to implement our strategy of advancing a portfolio of medicines into clinical development for each of the disease areas. Key programs include alpha-1 antitrypsin deficiency. Our AAT program, where we have multiple small molecule correctors in the clinic, aimed at addressing the underlying cause of disease in both the liver and the lung. These include VX-814, which has recently entered Phase II clinical development.

Beta-thalassemia and sickle cell disease, where we announced clinical data for 2 patients treated with CTX001, a onetime CRISPR-Cas9 ex vivo gene editing therapy, which suggest that we may be able to functionally cure these diseases.

FSGS, where our first small molecule aimed at halting the progression of the disease will move into Phase II development in 2020. And type 1 diabetes, where we are developing an autologous islet transplantation therapy with cells alone and a second with a combination of cells and a device to correct islet cell function and potentially transform the treatment of this disease.

Importantly, these pipeline programs now span multiple modalities, including small molecules where Vertex has excelled in the past, but also new approaches such as cell and genetic therapies. For these new modalities, we've acquired or partnered with leading companies who have the best teams and unique expertise to manufacture and deliver transformational therapies for diseases that fit our strategy.

And in business development, we completed more transactions in 2019 than in the 4 prior years, including our acquisitions of Semma with a leading cell therapy approach for type 1 diabetes, and Exonics, the leader in gene editing for DMD and DM1.

In summary, 2019 was the combination of almost a decade of focused execution against our strategy of discovering and developing transformative medicines for serious diseases in specialty areas, by focusing on validated targets and predictive biomarkers that will improve the probability of clinical success. Our strategy is playing out exactly as we had planned and will position us for continued short-term and long-term growth. The company has never been stronger or better positioned for future success in CF and beyond.

Let me now turn the call over to Reshma, who will talk in more detail about the year ahead.

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Reshma Kewalramani, Vertex Pharmaceuticals Incorporated - Chief Medical Officer [3]

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Thanks, Jeff. Our 2019 progress has positioned us for continued growth in 2020 and for many years to come. We are focused on bringing our CF medicines to more people, advancing our pipeline and building financial strength to support continued investment in internal and external innovation. In 2020, we expect to gain approval for the triple combination in Europe in patients 12 years and older and to submit TRIKAFTA for approval in the U.S. for children ages 6 to 11.

Beyond CF, we are advancing multiple molecules in our pipeline through late preclinical and early clinical development and are now entering a period of multiple proof-of-concept data readouts and clinical advances with potentially transformative medicine. With our AAT program, we recently initiated a Phase II proof-of-concept study of the small molecule corrector VX-814 in patients with 2 copies of the Z mutation and expect data from the study in 2020. In APOL1-mediated FSGS, we completed a Phase I study of VX-147 in late 2019 and expect to initiate an open-label Phase II proof-of-concept study in 2020 to evaluate the reduction in protein levels in the urine with VX-147.

In pain, having established proof-of-concept data from NaV1.8 inhibition with VX-150 in multiple Phase II studies, our focus is now to find the optimal molecule or molecules to advance into mid- and late-stage studies. We are continuing to advance a portfolio of medicines into clinical development, and we'll be advancing an additional molecule into Phase I development in the first half of 2020. We have discontinued Phase I development of VX-961 because it did not display an optimal PK and tolerability profile.

Beyond our small molecule programs, we've made significant progress in building and progressing a portfolio of cell and genetic therapies in line with our research strategy, primarily through our business development activities. We are highly encouraged by our recent clinical data for our CRISPR-Cas9 ex vivo gene editing treatment, CTX001, for beta-thalassemia and sickle cell disease. Both studies continue to enroll, and we expect to provide additional data for this program in 2020.

I'd also like to highlight our cell therapy approach for Type 1 diabetes. This program comes to us from our acquisition of Semma Therapeutics in October of 2019. The team of scientists at Semma have cracked the biology on both the production and scale-up of fully mature islet cells and has developed a novel implantable device to protect these cells from the immune system, while preserving cell health and function. We have set an ambitious goal to progress this program into clinical development in late 2020 or early 2021.

In summary, we've made outstanding progress in CF and multiple other diseases in 2019. And I look forward to updating you on our progress over the coming months and years.

I'll now turn the call over to Stuart.

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Stuart A. Arbuckle, Vertex Pharmaceuticals Incorporated - Executive VP & Chief Commercial Officer [4]

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Thanks, Reshma. I am pleased to review with you this evening, our strong commercial performance for 2019. Our full year 2019 CF revenues were $4 billion, up from $3 billion in 2018, which represents year-over-year growth of 32%. This growth in total revenues was driven primarily by the full year impact of the SYMDEKO launch in the U.S. and Germany, label expansions for our CF medicines globally and the early approval and launch of TRIKAFTA in the U.S.

The launch of TRIKAFTA is off to a very strong start. Our fourth quarter total CF product revenues were approximately $1.25 billion, including TRIKAFTA revenues of $420 million, making TRIKAFTA already our top-selling medicine. I would note that our fourth quarter revenues include, as expected, launch-related stocking of approximately $100 million. Approximately 18,000 patients are eligible for TRIKAFTA in the U.S., which represents the largest patient population eligible for one of our CF medicines at the time of approval and launch. For 6,000 of these people, this is the first time they have had a medicine to treat the underlying cause of their CF. We are seeing strong interest from all groups of eligible patients, including new initiations as well as patients transitioning from our other CFTR modulators.

Our commercial supply, market access, patient support, marketing and field teams were ready for an early approval. And since October, these teams have been doing a phenomenal job with CF centers and commercial and government payers. The centers and their multidisciplinary teams have done a remarkable job responding to the high patient demand. And while still early in the launch, we are on track to obtain broad reimbursement for TRIKAFTA in the U.S., similar to what we have seen for our other CF medicines. Together, these factors have combined to produce the strong start to the launch.

Outside the U.S., we reached multiple reimbursement agreements in 2019 in key countries, which will enable many thousands of patients to initiate treatment with certain Vertex medicines for the first time. While TRIKAFTA will be the main driver of Vertex's revenue growth in 2020, we also expect an increase in international revenues based on more patients initiating treatment with our medicines outside the U.S.

In summary, I am pleased that we are bringing our medicines to many more patients around the globe.

And with that, I'll now turn the call over to Charlie.

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Charles F. Wagner, Vertex Pharmaceuticals Incorporated - Executive VP & CFO [5]

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Thanks, Stuart. I will provide additional remarks this evening regarding our 2019 financial results, and I will also discuss our 2020 financial guidance. All of the results and guidance I will discuss are non-GAAP.

As Stuart mentioned, we had fourth quarter total CF product revenues of approximately $1.25 billion, a 45% increase compared to 2018. Our fourth quarter 2019 combined R&D and SG&A expenses were $496 million, including the operating expenses of Exonics and Semma compared to $400 million in the fourth quarter of 2018. Significant growth in revenues and disciplined spending in the fourth quarter resulted in operating income of $593 million, a 70% increase compared to the fourth quarter of 2018.

Net income for the fourth quarter of 2019 was $444 million compared to $337 million for the fourth quarter of 2018. Our full year financial results reflect a similar story of strong revenue growth and disciplined spending, resulting in exceptional operating income growth.

Our total CF revenues for 2019 were $4 billion, a 32% increase over full year 2018. Our 2019 combined R&D and SG&A expenses were $1.69 billion compared to $1.53 billion for 2018. Our full year operating income was $1.79 billion for 2019 compared to $1.11 billion for 2018, a year-over-year increase of more than 60%.

As our profitability and cash flow increased as a result of treating more CF patients globally, we have deliberately reinvested in both internal and external innovation to create future medicines. In 2019, we invested approximately $1.6 billion in external innovation through new acquisitions and collaborations. Even with the significant BD activity, we ended the year with approximately $3.8 billion in cash and marketable securities compared to $3.2 billion at the end of 2018. As we look ahead to 2020 and beyond, we expect continued increases in cash flow to provide more flexibility for additional investments to fuel our long-term growth.

Now on to 2020 guidance. Today, we're providing 2020 financial guidance for total CF product revenues as well as for combined non-GAAP R&D and SG&A expenses and our anticipated effective tax rate. The strong uptake of TRIKAFTA and the recent completion of reimbursement agreements outside the U.S. have positioned Vertex for continued strong revenue growth in 2020. Our 2020 guidance for total CF product revenues is $5.1 billion to $5.3 billion, which at the midpoint reflects approximately 30% growth over 2019.

I would note a few dynamics that are reflected in our 2020 guidance. As part of the strong launch of TRIKAFTA, that Stuart mentioned, we saw an expected launch-related inventory build of approximately $100 million in the fourth quarter that we do not expect to repeat in 2020. Also, as we move through 2020, as with all of our CFTR modulators, persistence and compliance dynamics will affect TRIKAFTA revenues, and therefore, our experience with our other CF medicines is factored into our guidance.

Lastly, we expect gross to net adjustments of 13% to 14% for 2020. Focusing in on Q1 2020, we expect our revenues to be modestly higher than Q4 2019 revenues. This reflects the impact of the fourth quarter inventory build as well as gross-to-net adjustments in the first quarter of each year that are generally higher relative to the previous quarter.

We expect 2020 combined R&D and SG&A expenses of $1.95 billion to $2 billion. The increase compared to 2019 is primarily driven by the launch of TRIKAFTA globally and the expansion of our R&D pipeline into additional diseases. Our R&D expense growth includes increased investment to advance our programs and selling genetic therapies, including type 1 diabetes and DMD.

Now to tax guidance, where we expect our full year non-GAAP tax rate to be 21% to 22%. The tax rate may fluctuate quarter-to-quarter, with the highest rate occurring in the fourth quarter. The vast majority of our tax provision will be noncash expense until we fully use our net operating losses. As Jeff noted, Vertex has a unique long-term growth potential that is based on continued revenue growth in CF and an expanding pipeline, and with continued spending discipline, we expect operating margins, earnings and cash flow to continue to increase.

Now back to Jeff for a few concluding comments.

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Jeffrey Marc Leiden, Vertex Pharmaceuticals Incorporated - Chairman, CEO & President [6]

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Edited Transcript of VRTX earnings conference call or presentation 30-Jan-20 9:30pm GMT - Yahoo Finance