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Alnylam Pharmaceuticals Inc (NASDAQ:ALNY)
Q4 2019 Earnings Call
Feb 6, 2020, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alnylam Pharmaceuticals conference call to discuss fourth quarter and year-end 2019 financial results. There will be a question-and-answer session to follow. Please be advised that this call is being played at the company's request.

I would now like to turn the call over to the company.

Christine Lindenboom -- Vice President of Investor Relations

Good morning. I'm Christine Lindenboom, Vice President of Investor Relations and Corporate Communications at Alnylam. With me today are John Maraganore, Chief Executive Officer; Barry Greene, President; Pushkal Garg, Chief Medical Officer; Jeff Poulton, Chief Financial Officer; and Yvonne Greenstreet, Chief Operating Officer. Akshay Vaishnaw, our President of R&D, is traveling today and unable to join us for today's call. For those of you participating via conference call, the accompanying slides can be accessed by going to the Events section of our newly redesigned investor page of our website at alnylam.com/events.

During today's call, as outlined on slide two, John will provide some introductory remarks and provide general context. Barry will provide an update on our commercial and medical affairs progress. Pushkal will review recent clinical updates. Jeff will review our Q4 and year-end 2019 financials and discuss our 2020 guidance, and Yvonne will provide a brief summary of upcoming milestones before opening the call for your questions. I would like to remind you that this call will contain remarks concerning Alnylam's future expectations, plans and prospects, which constitute forward-looking statements for the purpose of our safe harbor provision under the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recently quarterly report on file with the SEC. In addition, any forward-looking statements represent our views only as the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements.

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

John Maraganore -- Chief Executive Officer

Well, thanks, Christine, and thanks, everyone, for joining us this call -- on this call this morning. I'd like to make a few key points to provide some overall context for our discussion. First, in the fourth quarter and recent period, we made tremendous progress advancing our commercial products, bringing RNAi therapeutics to patients around the world. With ONPATTRO, we saw greater than 20% quarter-on-quarter growth in global ONPATTRO net revenues, driven by significant new patient adds in the U.S. and EU, along with a strong launch in Japan. With the FDA approval of GIVLAARI this past November and the positive CHMP opinion just last week, we became a multiproduct commercial company, and are pleased to now be making this medicine available to accept acute hepatic porphyria patients in the U.S. and soon in Europe.

In 2020, we look forward to continued global commercial execution with ONPATTRO and the global launch of GIVLAARI, bringing the benefits of these innovative therapies to patients around the world. Secondly, in the fourth quarter, we made strong progress on our pipeline, and we're excited to report positive top line results in the ILLUMINATE-A Phase III study of lumasiran in primary hyperoxaluria Type one, marking our third program to achieve positive Phase III data in 2019 alone. We're now focused on completing our regulatory filings for lumasiran. And assuming favorable regulatory reviews, we believe we should be in a position to bring this medicine to the market by the end of the year. Another notable milestone in Q4 was positive Phase III results for inclisiran, leading to the $9.7 billion acquisition of the Medicines Company by Novartis. We're very pleased to now be partnered with Novartis and look forward to supporting their efforts as they prepare to bring inclisiran to patients around the world.

We believe that improved inclisiran has the potential to be a transformative medicine for patients, representing an important future source of potential product revenues for Alnylam and also a potential opportunity to strengthen our balance sheet outside of the equity markets. In addition, we continue to advance our ongoing [Technical Issues] for patisiran, the unbranded name for ONPATTRO, and vutrisiran into the hereditary and wild-type ATTR amyloidosis cardiomyopathy esthetics. We believe that our approach is silencing the production of TTR with an RNAi therapeutic as the potential to be the best-in-class mechanism in ATTR amyloidosis. We also believe that the potential opportunity for patisiran and then vutrisiran in the ATTR amyloidosis cardiomyopathy indication, assuming positive Phase III results and regulatory review, could represent a multibillion-dollar anchor opportunity for building Alnylam, similar to what Regeneron had with EYLEA or Celgene with Revlimid. Now as you know, our robust product pipeline also includes some earlier stage clinical programs in areas such as complement-mediated diseases, hypertension, chronic HBV infection and alpha-1 liver disease, where we were pleased to share some of the initial data from these programs at our R&D Day this past November. And you should expect to see more data from these efforts throughout 2020, highlighting Alnylam's next wave of potential opportunities for sustainable innovation and growth. The final point I'd like to make is that Alnylam is now very much focused on achieving a self-sustainable financial profile.

Our CFO, Jeff Poulton, will elaborate on this later in the call. But to be very clear, realizing this goal is not a question of if, but rather a question of optimizing the when and the how with the goal of achieving significant impact for patients and delivering strong value for our shareholders. We believe that we have a clear line of sight to get there. And over the next five or six years, we see an opportunity of building a top five biopharma company, bringing transformative medicines in both rare and common diseases to patients around the world and growing with excellent innovation and responsibility. We're committed to this future for Alnylam, and we believe that we're very well positioned to achieve it.

With that, I'll now turn the call over to Barry to review our commercial and medical affairs progress in more detail. Barry?

Barry Greene -- President

Thanks, John, and good morning, everyone. I'll begin by reviewing ONPATTRO's commercial performance. We achieved $55.8 million in global ONPATTRO net product revenues in the fourth quarter, representing 21% quarter-on-quarter growth compared with Q3. And we achieved $166.4 million in global ONPATTRO net revenues for the full year 2019. In terms of geographic split, we achieved $35.8 million from the U.S. and $20 million from the rest of the world. U.S. ONPATTRO net sales in the fourth quarter represented 6% quarter-on-quarter growth, while underlying demand sales growth was 12%, driven by new patients initiating therapy. Jeff will comment on the differences between reported and underlying demand sales growth later in the call. International sales represented 61% quarter-on-quarter growth, which was driven by continued execution in EU countries, where pricing and reimbursement exists, and with strong recent launches in both the U.K. and Japan. Now most importantly, as of year-end, over 750 patients worldwide were receiving commercial ONPATTRO treatment.

When we include patients in clinical trials and in our expanded access program, or EAP, we achieved over 1,000 patients worldwide, who are being treated with ONPATTRO or patisiran as of year-end, an exciting milestone in our overall efforts and highly encouraging for the overall hATTR community. Now let's move on to review some of the market dynamics in the U.S. specifically. On the physician front, we continue to see growth in both number of new prescribers as well as repeat prescribers, with our total number of ONPATTRO prescribers now at over 230 since launch. We believe continued growth in new prescribers reflect ever-increasing disease awareness on part of HCPs, driven largely by Congress presentation and the benefits of multiple players engaged in disease state education. Regarding the mix of U.S. prescribers in the fourth quarter, based on start forms received, about 41% of start forms were from neurologists, with about 37% coming from cardiologists.

As a remainder, all -- as a reminder, all start forms, regardless of specialty, are for the treatment of the polyneuropathy of hATTR amyloidosis. For 2019 overall, cardiologists accounted for 44% of start forms submitted, with 38% coming from neurologists and 18% from other physician specialties. Overall, and as many of you heard at R&D Day, we believe HCPs across specialties in the U.S. are growing increasingly comfortable with treating the polyneuropathy of ATTR amyloidosis with ONPATTRO. Adherence to therapy also remains very strong to date, a very encouraging sign and consistent with the APOLLO Phase III data when real-world evidence lines up with clinical trial results. We continue to estimate over 90% adherence rate for commercial ONPATTRO. Regarding U.S. market access, as reported by external coverage reports, we're very pleased that we now have confirmed access to ONPATTRO if prescribed for more than 99% of U.S. lives across commercial, Medicare, Medicaid and other government paying categories. Even in an increasingly competitive landscape, we continue to effectively partner with U.S. payers and have avoided the payer and patient out-of-pocket headwinds often reported with other orphan drug launches.

We're very proud of the result in the complex U.S. market access environment and believe it reflects the constructive, collaborative, proactive approach we've adopted with the payer community, including the use of value-based agreements, or VBAs. In the United States, we've now completed definitive VBAs for ONPATTRO with 15 commercial payers, including each of the top five commercial payers and eight of the top 10. These VBAs now cover over 130 million U.S. lives. Let's now turn to the rest of the world, where we're also very pleased with ONPATTRO performance. As I noted earlier, we achieved $20 million in international net product revenues in the fourth quarter, reflecting 61% quarter-on-quarter revenue growth and 53% growth on new patient adds. This is also the first full quarter in which we recognized sales in Japan, where we saw strong demand and initial performance in this important region, where there is endemic disease. As we've previously mentioned, we anticipate that exiting 2020, Japan will likely be our second largest country after the U.S. for ONPATTRO, both in terms of patients on commercial drug and, of course, revenue. Other notable achievements during the quarter include the continued launch of ONPATTRO in the U.K. and achieving a pricing reimbursement in several countries, including Belgium, Israel and Italy.

Through direct reimbursement, named patient sales or paid expanded access, we're now selling ONPATTRO in 16 countries outside the United States. We're seeing the source of our international business coming from both frontline treatment as well as switches from other products, such as TTR stabilizers. We believe this highlights the value that the hereditary ATTR community is seen with ONPATTRO. Further, as we achieve reimbursement in different EU countries, we're seeing patients, who've been on our expanded access program, convert to commercial drug, as we saw recently in the U.K. Our team also remains committed to addressing the challenge of raising disease awareness and improving diagnosis in ATTR amyloidosis. As we've highlighted previously, our Alnylam Act program is a third-party genetic screening initiative in the U.S. and Canada aimed at facilitating diagnosis for the benefit of patients suspected of having hATTR amyloidosis. As of January, over 21,700 samples have been submitted, out of which over 1,300 have tested positive for pathogenic TTR mutation, continuing a consistent percentage of positive mutation results. We see this as highly encouraging. Let me now turn to GIVLAARI and the initial progress we've made in the short period and the drug's early approval in November.

Through the initial six weeks from approval of GIVLAARI in the U.S. through the end of 2019, a total of 13 start forms were submitted. Net product revenues for the fourth quarter were approximately $200,000, which represents initial channel stocking. We're very pleased with the strong initial interest from patients, physicians and payers, which continues in the first few weeks of 2020. We've been in discussions with multiple commercial and government payers and have made progress toward establishing VBAs for GIVLAARI, including the implementation of our newly formed Prevalence-Based Adjustment. As mentioned, we're highly leveraging the capabilities built for ONPATTRO launch. And following the best practice to develop country-by-country, our team is focused on improving the awareness and diagnosis of acute hepatic porphyria in the HCP, patient and payer communities and laying the groundwork for a successful launch. To that end, the Ironwood and Alnylam teams are fully staffed, trained and in the field and, as I mentioned, being received very well. As you're aware, through Alnylam Act, we provide access to third-party genetic testing for individuals in the U.S. or Canada, who may carry a gene mutation known to be associated with AHP. While this program for AHP is still in early stages, we report 705 tests submitted in 78 patients to approximately 11% confirmed of AHP associated gene mutations as of January 2020. As we noted last week, we received positive CHMP opinion for givosiran for the treatment of AHP in adults and adolescents age 12 and over in the EU.

We now look forward to expected decision for GIVLAARI by the year-end commission this year, which will be followed by commercial launch in the EU following pricing and reimbursement negotiations country by country.

With that, I now turn the call over to Pushkal to review our recent R&D and pipeline progress. Pushkal?

Pushkal Garg -- Chief Medical Officer

Thanks, Barry, and good morning, everyone. In the interest of time, I'm going to focus my comments on our progress in advancing our six late-stage programs, starting first with the recent FDA approval for GIVLAARI. As John and Barry mentioned, we were really excited to receive early approval for GIVLAARI, our second RNAi therapeutic last November in the United States, which was followed by a positive CHMP opinion just last week in the European Union. And while we eagerly await the European Commission decision, we're delighted that both authorities have granted broad indications for GIVLAARI for the treatment of acute hepatic porphyria based on the efficacy and safety data for the pivotal ENVISION study, which will enable us to address a broad range of patients suffering from this devastating disease. Let me now turn to our efforts in ATTR amyloidosis, where we are working diligently to advance our two product candidates, patisiran and vutrisiran. And while patisiran is currently approved in multiple markets around the world to treat the polyneuropathy associated with hereditary ATTR amyloidosis, we're also conducting the APOLLO-B Phase III study as a potential path toward expanding the products label for the treatment of cardiomyopathy in both hereditary and wild-type ATTR amyloidosis patients.

APOLLO-B is a study in approximately 300 patients using a 6-minute walk as a primary endpoint with other important secondaries, including the rates of death and hospitalizations. Enrollment is ongoing and expected to complete late this year. And if the study is positive, we plan to seek regulatory support for an expanded label for patisiran in approximately the late 2021 to early 2022 time frame. In parallel, we're also advancing vutrisiran, which is delivered by a quarterly subcutaneous injection, and is also in development for ATTR amyloidosis. Here we're conducting two Phase III studies. The first is HELIOS-A, which is enrolling hereditary ATTR amyloidosis patients with polyneuropathy. We're really pleased with enrollment in HELIOS-A. And as announced last month at JPMorgan, we've enrolled over 85% of the study and expect to report top line results in early 2021. Back in November, we also initiated the second Phase III study of vutrisiran, HELIOS-B, which is conducted -- being conducted in both hereditary and wild-type ATTR amyloidosis patients with cardiomyopathy. This study, if successful and following regulatory approval, could allow vutrisiran to enter the very large wild-type ATTR market with an outcomes-based label that we believe would be optimal for competitive positioning of the product.

The primary endpoint of the study is a composite outcome of all-cause mortality and recurrent CV hospitalizations, which will be assessed at 130. And we may also conduct an interim analysis, providing the opportunity for an earlier data readout. I'll now turn to recent progress with lumasiran, an investigational RNAi therapeutic that we're developing for the treatment of primary hyperoxaluria Type one or PH1. PH1 is an ultra-rare autosomal recessive disease caused by a genetic defect in liver enzyme AGT, that results then in hepatic overproduction of an insoluble metabolite called oxalate. This oxalate can deposit first in the kidney, causing recurrent painful kidney stones, leading to end-stage renal disease and also significant systemic complications. There are about 3,000 to 5,000 patients with this serious disease, and their treatment options are very limited. Today, they're primarily medically managed with hyperhydration and dialysis in severe cases and ultimately require a dual liver and kidney transplant. To address this need, we are evaluating the safety and efficacy of lumasiran in the ILLUMINATE program. This is a comprehensive set of studies across the entire spectrum of PH1 disease. It includes ILLUMINATE-A, our pivotal study in patients aged six and older with mild to moderate renal impairment. It also includes the ILLUMINATE-B study in pediatric patients less than six years old with mild to moderate renal impairment, which, as we announced in our press release today, has now completed enrollment. And it also includes a third study, ILLUMINATE-C, which is being conducted in patients with severe renal impairment.

Together, the ILLUMINATE program is the most comprehensive set of studies ever conducted in PH1. Now back in December, we reported positive top line results from the ILLUMINATE-A Phase III trial. Lumasiran showed a highly significant effect on the primary endpoint of the percent change from baseline and 24-hour urinary oxalate excretion averaged across months three to six in drug-treated patients compared with placebo. The study also achieved statistically significant results for all tested secondary endpoints, including the proportions of patients who achieved near normalization or normalization of urinary oxalate. And on the safety side, we were very encouraged by the results there as well. There were no serious or severe adverse events, and the safety profile was very much in line with what we've reported previously for lumasiran, including no significant LFT elevations. The full study results will be presented in late March at the OxalEurope meeting in Amsterdam. And as John mentioned, we recently initiated our rolling NDA submission for lumasiran and plan to complete our NDA submission as well as our MAA submission in early 2020. As you also know, we have two additional late-stage programs that are in development with partners. This includes inclisiran in development for hypercholesterolemia, which is partnered now with Novartis; and fitusiran in development for hemophilia A or B with or without inhibitors, partnering with Sanofi.

We're very excited about the prospects for both of these products. Both cases, they have highly differentiated profiles compared to agents that are either on the market or in development. And as Novartis recently announced, the NDA and MAA for inclisiran have now been filed. Of course, in addition to our late-stage clinical programs, our robust pipeline of early stage programs is being advanced to a sustained innovation growth, and we look forward to updating you on these programs throughout 2020.

So with that, let me now turn it over to Jeff to review our financial results and outlook. Jeff?

Jeff Poulton -- Chief Financial Officer

Thanks, Pushkal, and good morning, everyone. I'm pleased to present Alnylam's Q4 and full year 2019 results. 2019 was a significant year for Alnylam as it marked our first full year of commercial operations with the launch of ONPATTRO occurring in the second half of 2018. As Barry has already highlighted, 2019 was a year of strong commercial execution, as we now have more than 750 patients on commercial ONPATTRO across 17 markets globally. After commenting on our fourth quarter and full year 2019 results, I will also provide our financial guidance for 2020. Please now turn to slide 24 for a summary of our Q4 and full year 2019 results. Barry noted global ONPATTRO net product revenues in the fourth quarter were $55.8 million, representing 21% global growth from the third quarter, driven by new patient growth across all markets. U.S. ONPATTRO revenue grew 6% in the fourth quarter in comparison to Q3, while underlying demand sales growth was 12% in the quarter. The reason for the difference between reported and underlying demand sales growth was higher sales deductions in the fourth quarter.

The full year gross to net percentage for ONPATTRO in the U.S. was approximately 20% and in line with our expectations. Additionally, U.S. Q4 ONPATTRO sales included a modest amount of inventory stocking, but this had minimal impact on reported growth versus the third quarter as a similar amount of modest destocking occurred in Q3. Inventory levels in the U.S. at year-end remained within target levels of two to three weeks. As Barry has already noted, the growth in our international markets was particularly strong in the quarter at 61% compared with Q3, driven by strong launches in both the U.K. and Japan. Full year ONPATTRO global net revenue was $166.4 million, driven by growth in both existing and new markets over the course of the year. The U.S. represented about 70% of full year ONPATTRO sales, and our international markets represented 30%. We also recognized our first sales of GIVLAARI in the quarter following FDA approval on November 20. Net sales of approximately $0.2 million represent initial channel stocking. We look forward to updating you on the progress of our GIVLAARI launch throughout 2020. Net revenue from collaborations was $15.7 million in the fourth quarter, an approximate 75% increase from the fourth quarter of the prior year. Primary driver for the increase was revenue recognized under the Regeneron collaboration that was established in the second quarter of 2019.

Net revenue from collaborations was $53.2 million for the full year, representing a 15% decrease from the prior year, primarily due to reduced revenue from our Sanofi-Genzyme collaboration, offset by revenues from our Regeneron collaboration. Cost of goods sold in Q4 was $12.2 million, resulting in a 78% gross margin on product sales. Gross margin in the quarter was impacted by an approximate $5 million writedown for excess and obsolete ONPATTRO inventory that had been manufactured conservatively to ensure adequate stock was available to support initial launch demand. Absent this write-off, gross margin for Q4 would have been approximately 87%, consistent with gross margin in prior quarters of 2019. Gross margin on product sales was 85% for the full year.

Non-GAAP research and development costs were $166.5 million in Q4, representing the peak quarterly R&D spend during the year. Q4 spend was impacted by a high level of clinical material manufactured for future trials. For the full year, non-GAAP R&D expenses were $566.2 million, representing a 33% increase from the prior year. The majority of our R&D spend or approximately 70% in 2019 went toward supporting late-stage clinical programs, patisiran, vutrisiran, givosiran and lumasiran. Non-GAAP selling, general and administrative expenses were $124.9 million in Q4, also representing the peak quarterly SG&A spend during the year. Q4 expense was impacted by spend on GIVLAARI, given the November 20 FDA approval and preparations for commercial launch. SG&A spend for the full year was $393.1 million, representing 29% growth from 2018, due primarily to the continued expansion of our global commercial infrastructure to support the ongoing launch of ONPATTRO and initial launch activity for GIVLAARI. Our balance sheet remains strong as we ended 2019 with a cash, cash equivalents and investments balance of $1.55 billion compared with $1.13 billion at the end of 2018.

The increase was due to proceeds received under our equity offering in the first quarter of 2019 and proceeds received under our collaboration and equity agreements with Regeneron, offset by cash used in our operations and capital expenditures. Now turning to slide 25 and our 2020 financial guidance. Starting with our global net product sales guidance for ONPATTRO, which we are providing for the first time, we project our global net sales in 2020 will be between $285 million and $315 million for ONPATTRO. The midpoint of the guidance range represents 80% growth versus 2019. We believe growth will continue to be driven by both new patient funding in existing markets and expansion into new markets. Please note that we are not providing net product sales for GIVLAARI, given that 2020 represents its initial commercial launch year. Our guidance for net revenue collaborations is a range between $100 million and $150 million, with the midpoint of the range representing 135% growth compared with 2019. Growth in 2020 is expected to come primarily from our collaboration with Regeneron. Our guidance for non-GAAP R&D and SG&A expense is a range between $1,025,000,000 and $1,125,000,000. The midpoint of the guidance range represents a projected 12% increase in 2020 compared with 2019.

Key drivers of expense growth are expected to include investment in our early stage R&D pipeline via our Regeneron collaboration and continued SG&A investment in ONPATTRO and now GIVLAARI. Importantly, as we are now focused on becoming a self-sustainable business, this 2020 projected 12% operating expense growth is significantly below the 31% growth in 2019 and combined R&D and SG&A expense. The moderating growth in operating expenses reflects discipline in our approach to capital allocation and the initial benefit of operating leverage from the commercial infrastructure we have developed to support ONPATTRO and now GIVLAARI. As we've discussed previously, we believe 2019 represents our peak non-GAAP net operating loss year. The top line and non-GAAP operating expense guidance we have provided today for 2020 is consistent with this, and we believe represents an important step on our path to becoming a profitable company. And finally, our balance sheet remains strong as we project the $1.55 billion in cash, and investments on hand at the end of 2019 will support company operations for multiple years based on current operating plans.

With that, I'll now turn the call over to Yvonne to review our goals for the remainder of the year. Yvonne?

Yvonne Greenstreet -- Chief Operating Officer

Thanks, Jeff, and hello, everyone. We believe 2020 is poised to be another catalyst-rich year for Alnylam. To start with, we plan to continue our global commercialization of ONPATTRO as well as the global launch of GIVLAARI, including in Europe, where we have a positive CHMP opinion, and expect the European Commission decision in the coming months. We also expect two additional regulatory approvals by the end of the year, lumasiran and inclisiran. We're executing on six late stage programs in nine distinct clinical trials, including APOLLO-B and our HELIOS-A and HELIOS-B studies. And as mentioned in today's press release, we plan to highlight additional clinical data from our patisiran development program at the upcoming ISA meeting in early March in Tarragona, Spain. With lumasiran, we continue to look forward to presenting full results from the ILLUMINATE-A Phase III study at the OxalEurope International Congress on March 31 in Amsterdam.

Furthermore, now having completed enrollment to the ILLUMINATE-B study in PH1 patients under six years of age, we remain on track to report top line results from that study in mid-2020. And of course, we'll also continue advancing the rest of our pipeline as well as exciting preclinical efforts and will highlight milestones we achieve with these programs throughout the year as they occur. Notably, we aim to deliver two to four new IND filings, including ALS-HSD for NASH and ALN-LEC for LECT2 amyloidosis in 2020 from our organic product engine, fueling sustainable innovation.

Let me now turn it back to Christine to coordinate our Q&A session. Christine?

Christine Lindenboom -- Vice President of Investor Relations

Thank you, Yvonne. Operator, we will now open the call for questions. [Operator Instructions]

Questions and Answers:

Operator

Thank you, Madam. [Operator Instructions] Our first question comes from Alethia Young of Cantor Fitzgerald. Please go ahead.

Emma -- Cantor Fitzgerald -- Analyst

Hi, this is Emma on for Alethia. So for GIVLAARI, were all 13 of the initial start forms from the major porphyria centers of Jenny come through the Ironwood GI sales force or many other specialties?

John Maraganore -- Chief Executive Officer

Okay. So Emma, I think we didn't hear you that clearly. I think you were asking about the Ironwood collaboration and what we're learning on the GIVLAARI side from our colleagues there. Barry, do you want to take that?

Barry Greene -- President

Yes. Emma, thanks for the question. So as I mentioned on the call, both the Alnylam and Ironwood forces are out there educating the healthcare community, engaging with the patient association. The 13 start forms came from a variety of prescribers. We're not really giving much color on exactly where they came from yet, but we can say, right now, they are coming from porphyria centers and local physicians treating these patients. And we are seeing success in some of the handoff from Ironwood already. And we'll comment more with more data next quarter on all of that.

John Maraganore -- Chief Executive Officer

Yes, that's right, Barry. And I would just add that we're really excited about how this is -- how this launch is going so far. We are seeing very strong demand from physicians and patients. And we're looking forward to how this proceeds during the course of the year. Thank you for your question.

Emma -- Cantor Fitzgerald -- Analyst

Great. And do you intend to continue updating on the touch of patient numbers over 2020? Or is that something you're moving away from now that you're guiding on revenue?

John Maraganore -- Chief Executive Officer

I mean, we'll continue to provide the patient numbers on commercial drug and also the sort of broad umbrella number that we provide around patients that include our expanded access program and clinical studies. We think it's -- in addition to the revenues, we think it continues to be an important metric that people will like to see. So we do plan on continuing that. But thanks for your question on that.

Emma -- Cantor Fitzgerald -- Analyst

Thank you.

Operator

We will now move to our next question from Gena Wang of Barclays. Please go ahead.

David -- Barclays -- Analyst

Thank you guys for the call. This is David [Phonetic] for Gena. My first question's on diagnosis for ATTR polyneuropathy. Do you see a positive impact for the ATTR polyneuropathy diagnosis from Pfizer's efforts on the ATTR cardiomyopathy diagnosis with this launch?

John Maraganore -- Chief Executive Officer

Yes, David. That's actually a fabulous question and one that -- let me just make some initial comments, and then maybe Pushkal can talk a little bit about some of the diagnostic evolution in the whole landscape. And then Barry can comment as well. Obviously, we're very focused on ONPATTRO's potential value for treating the polyneuropathy of hereditary ATTR amyloidosis in adult patients. And as we continue on that effort, we also realize that polyneuropathy is being recognized in a significant number of patients throughout the spectrum of hATTR, including even the V122I patient population that historically have been viewed as just cardiomyopathy patients. But it turns out that many of these, potentially over 50%, are being found to have polyneuropathy. So as a result, the work that's going on in the field to identify patients with hATTR amyloidosis really can potentially lead to patients being discovered to have polyneuropathy. And that's really an important dynamic that's taken place right now. So maybe, Pushkal, you can say a few words on the diagnostic method evolution, and then, Barry, a little bit on what we're hearing in the field out there. So...

Pushkal Garg -- Chief Medical Officer

Absolutely. David, just to follow on, on some of John's comments, I think there's a greatly increased awareness around this disease, first of all, based on now therapeutics that have become available for patients with this, what was prepared for an unrecognized disease. It also used to be sort of considered two separate diseases, a polyneuropathy form and a cardiomyopathy form, and I think, as John alluded to, really seeing overlap in patients and that it's really one disease. So I think what you're seeing is guidelines starting to emerge and physicians starting to congregate around how to treat, diagnose and treat these patients, looking for red flag symptoms like carpal tunnel syndrome and other manifestations, recommending genotyping, so that we can understand who has the genetic mutations and the hereditary forms of this.

And then importantly, the advent of noninvasive ways to diagnose these patients. For example, looking at technician scanning to identify where patients have cardiac involvement. And then because of this sort of mixed phenotype that we're seeing increasing the fact that patients have to get evaluated in amyloidosis centers and by multidisciplinary physicians to actually in clinics to look for both the polyneuropathy and cardiac manifestations of the disease. And I think that's leading to increased awareness, diagnosis and then the discussion of treatments for these patients. Maybe Barry can pick it up from there.

Barry Greene -- President

Yes. You covered it completely. The only thing I will add is it's our efforts and other companies' efforts doing disease state education. But very importantly, the amyloidosis society, the physicians at cardiac, neurology and even gastroenterology clinics have hold tracks, educating broad swaths of physicians to look for TTR amyloidosis and to make sure that they do genetic testing in the case of hereditary TTR amyloidosis in this multi system, multi-function disease.

John Maraganore -- Chief Executive Officer

Yes, that's great. Thank you, David, for that question.

Operator

We will now move to our -- to the line of Salveen Richter of Goldman Sachs. Please go ahead.

Salveen Richter -- Goldman Sachs -- Analyst

Good morning. Thanks for taking my question. Could you just walk through the dynamics behind your 2020 guidance, particularly as the ramp continues in Japan here, and just talk about external factors that are at play? And then secondly, you talked about this higher sales deduction that played out in Q4. Do you think that's something we should monitor on a go-forward basis?

John Maraganore -- Chief Executive Officer

Yes. Thanks, Salveen. I'm going to hand it over to Jeff. Let me just say one thing on guidance. It's the first time we're obviously providing revenue guidance as a company, and we do think it's an appropriate thing to do now that we've got one year of launch behind us with ONPATTRO. And so this is an approach that we do intend to take with other products as we bring them to market. After the first year or so, where we don't yet have visibility, like in the case of GIVLAARI right now, we won't provide guidance. And then after about a year's worth of experience, we will. So this -- you'll see more of this going forward from Alnylam. But let me now turn it over to Jeff to comment on the specific questions you asked.

Jeff Poulton -- Chief Financial Officer

Yes. So Salveen, the guidance range is $285 million to $315 million for ONPATTRO, which represents 80% growth year-over-year if we hit the midpoint of that. We expect that growth to be driven by new patients coming on to therapy in existing markets and bringing new markets online when we get access in reimbursement. I would say we expect the growth outside the U.S. to be higher in 2020 than in the U.S. just given that the dynamics of getting access in reimbursement outside the U.S. have taken longer. So many of the markets that came online outside the U.S. were only online for a partial year in 2019. Barry can comment further if he wants after I answer your next question. The question about sales deductions in the fourth quarter on whether or not that should be something that would be monitored in terms of a trend, I think not. The way sales deductions work is you make estimates at the time the sales are booked for sales deductions.

And as you get actuals against those estimates, you true those numbers up. And over time, quarter-to-quarter, that can lead to some changes, some distortions quarter-to-quarter. And that's what happened in the fourth quarter. We had an adjustment that resulted in a slightly higher number in the fourth quarter. But for the full year, our gross to net deductions, both in the U.S. and globally, were right in line with what we expected globally, right in line with the 25% guidance we had provided for the year. I don't expect that to be dramatically different in 2020.

John Maraganore -- Chief Executive Officer

And Barry, anything to add?

Barry Greene -- President

Yes. Just to emphasize, and Jeff covered it incredibly well. Just to emphasize, again, the growth will come from patients continuing on therapy. We're very enthusiastic that there's over a 90% adherence rate, representing what we saw in the APOLLO clinical trials, where over half of the patients are stabilized or improved in their polyneuropathy. It's quite remarkable to see and anecdotally hear those stories. And then, as Jeff said, we'll continue to bring new patients on the markets that are opened. We'll continue to open new markets, and we'll continue to evidence generation of all our growth drivers of new patients. The only other thing to add is, right now, the pricing and reimbursement we're getting outside the United States continues to be very strong, representing the value that ONPATTRO's bringing to the treatment of polyneuropathy in these hereditary ATTR patients.

John Maraganore -- Chief Executive Officer

Terrific. Salveen, does that answer your questions?

Salveen Richter -- Goldman Sachs -- Analyst

Yes, very helpful. Thank you. Thank you very much.

Operator

We will now move to our next question from the line of David Lebowitz of Morgan Stanley. Please go ahead.

David Lebowitz -- Morgan Stanley -- Analyst

Thank you very much for taking my question. When you look at the ONPATTRO launch since the beginning, has there been any evolution in the type of patient, the incremental patient diagnosed and put on drug from the beginning of the launch to six months into the launch to now? And how might you expect that profile of the patient to change six months or a year from now?

John Maraganore -- Chief Executive Officer

Yes, that's a great question. Barry, you want to handle that?

Barry Greene -- President

Yes. So David, great question. Let me first say that based upon the genetic makeup of any different country, each country, quite frankly, has very different dynamics. The United States dynamic has a significant amount of V122I and V30M. Other countries have different mutations. I'd say, if we go back a couple of years ago, and as Pushkal mentioned, most people thought of hereditary TTR as either a polyneuropathy or a cardiomyopathy disease. And the big fundamental shift we've seen is an appreciation that this is a mixed phenotype disease. And in fact, most patients, including V122I patients have mixed disease. So the ability to see and look for polyneuropathy has increased over the years and should continue to increase as education continues in the healthcare community.

John Maraganore -- Chief Executive Officer

The only thing I would add, David, which relates to the U.S. market, which certainly did evolve over the course of the year, was the advent of combination use. And we're aware of a significant and probably growing number, we don't have precise numbers on this, but a growing number of patients where we understand that they're receiving a TTR stabilizer in addition to their ONPATTRO. So it reflects physicians who are choosing to treat the cardiomyopathy with the stabilizer drug that's approved for that indication and the polyneuropathy with ONPATTRO. And that really is something which has changed over time. And physicians are finding the ability to continue to receive robust reimbursement for ONPATTRO in that specific setting. So that is something which did change over the course of the year. I expect it to continue to change and evolve during 2020.

David Lebowitz -- Morgan Stanley -- Analyst

Thank you very much. Friends in the question.

Operator

We will now move to our next question from the line of Do Kim of BMO Capital Markets. Please go ahead.

Do Kim -- BMO Capital Markets -- Analyst

Hi, good morning. Thanks for taking my question. On ONPATTRO, the fourth quarter U.S. sales, were there any other factors besides the gross to net deduction that impacted the growth? Was there increased competition from the ongoing clinical trials in this -- to this patient population? And also, on your 2020 ONPATTRO guidance, are you assuming any first quarter seasonality? Any headwinds from reimbursement resets?

John Maraganore -- Chief Executive Officer

Yes. Let's turn that over to Jeff. Jeff?

Jeff Poulton -- Chief Financial Officer

So first question related to the growth dynamics in the fourth quarter, so underlying demand growth, so products shipped to patients, to fulfill patient orders was 12% growth in the quarter. The reported product sales for the quarter were only 6%. The reason for the delta was gross to net. The gross to net deductions that we booked in Q4 were about 5% higher than what we booked in Q3, which was the reason for lower reported net sales growth.

John Maraganore -- Chief Executive Officer

Maybe you could repeat the second question.

Do Kim -- BMO Capital Markets -- Analyst

The second question is on your guidance, whether you expect any seasonality in the quarter.

Jeff Poulton -- Chief Financial Officer

No, no. We don't expect any seasonality. I would, again, expect continued and steady growth quarter-to-quarter.

John Maraganore -- Chief Executive Officer

Barry, do you want to add anything?

Barry Greene -- President

Yes. Just to emphasize that as we presented multiple times, we've built a very robust commercialization capability. And the United States have Alnylam Assist, which proactively reaches out to patients to ensure drug continuity. So we are seeing, as we mentioned, patients who are benefiting staying on drugs and a significant number of patient adds across the country and feel really good that we've been through the bolus of the United States, but we continue to see really nice patient growth.

Do Kim -- BMO Capital Markets -- Analyst

Very, thank you.

Operator

Thank you. We will now move to our next question from Ritu Baral of Cowen. Please go ahead.

Ritu Baral -- Cowen -- Analyst

Good morning, everyone. Thanks for taking the question. Can you guys comment on how much Japan represented of 4Q ex U.S. sales and the sales growth as well as switching patterns? You mentioned switching patterns in Europe and Japan. And then I have a follow-up on APOLLO-B.

John Maraganore -- Chief Executive Officer

Yes. That's a great question, Ritu. Let me -- on the breakdown, we are going to provide that breakdown for rest of world. Yes, we probably will need to start in the first quarter as Japan grows and becomes a more significant proportion of our rest of world sales. So -- but right now, it's lumped together. What we can say is that Japan was very strong. And we're very pleased with the growth in Japan, but we also had some markets in Europe, notably the U.K., where we had a full quarter of reimbursed drug during Q4. So that was also notable. Anything, Jeff, to add to that?

Jeff Poulton -- Chief Financial Officer

I think you hit it. I mean, for sure, in the fourth quarter, again, 61% growth outside the U.S. The U.K. and Japan were significant contributors to that growth from the quarter.

John Maraganore -- Chief Executive Officer

Yes.

Yvonne Greenstreet -- Chief Operating Officer

I think probably just one thing, though, John. Switching...

John Maraganore -- Chief Executive Officer

Yes.

Yvonne Greenstreet -- Chief Operating Officer

In Japan, where patients sort of have been on stabilizers for a period of time continue to progress. I think we're seeing physicians switching those patients to ONPATTRO.

John Maraganore -- Chief Executive Officer

Absolutely. And Barry, anything else to add?

Barry Greene -- President

No. I was going to emphasize what Yvonne said. The dynamics in countries where physicians have extensive experience, as again for the polyneuropathy, and, quite frankly, not a positive experience, it's been mostly a switch. In the United States, where experience is a little bit newer, and as John mentioned, the cardiac indication, we're seeing a little bit more combination use. We are also seeing newly diagnosed patients on ONPATTRO in countries around the world. So it's not only a switch dynamic.

John Maraganore -- Chief Executive Officer

Does that help, Ritu?

Ritu Baral -- Cowen -- Analyst

Great. Very helpful. And then my question on APOLLO-B, now that we're getting closer to enrollment completion, as you mentioned, later this year, can you remind us what the powering around 6-minute walk -- the 6-minute walk endpoint for that study will be? And do you have any general thoughts on what that data could mean as we look at and model ONPATTRO into 2021 and 2022? How do you think that 6-minute walk data compares meaningfulness-wise versus outcomes data from the same dose?

John Maraganore -- Chief Executive Officer

Well, that's a really great question. We're going to -- I'm going to make a couple of comments, then we'll go to Pushkal, then to Barry. Let me just say for starters that we really are excited about APOLLO-B and then HELIOS-B. And we really do view these two trials as being critical elements to the potential expansion -- assuming the trials are positive and regulatory reviews are positive, the potential expansion of our broader ATTR franchise into the very, very large wild-type ATTR cardiomyopathy setting very specifically. So we do think this is very, very critical for the company, and we think it's a very important value creation opportunity for Alnylam. So with that, Pushkal, do you want to comment on the APOLLO-B design?

Pushkal Garg -- Chief Medical Officer

Yes, absolutely. Thanks, Ritu, for your question. So just the big picture on this study, right, it's a-300 person study enrolling both patients with wild-type and hereditary TTR with cardiomyopathy, and we're following them for 12 months for a 6-minute walk distance endpoint. And I think in terms of -- it's a global study. In terms of -- I think what we're seeing in terms of enrollment is great enthusiasm. And I think that's really spurred on by the fact that investigators are very enthusiastic about some of the post-talk and exploratory data that were published last year in circulation coming out of the APOLLO study suggesting that ONPATTRO may have favorable effects on some of the cardiac aspects of the disease and really want to do and support this definitive study to understand that.

In terms of the endpoint, the 6-minute walk distance test is a validated endpoint that's been recognized by the health authorities as registerable. And so we're encouraged by that. And obviously, we have secondary endpoints to look at symptomatology, using the KCCQ, death and hospitalization outcomes as well that we can follow. In terms of powering, the powering, we're obviously informed by prior studies, including the ATTR-ACT study. And so we can use that to really understand how to well -- to really well power this study. So it's a very well-powered study for the primary endpoint. And so we're quite encouraged that we'll be able to see a positive result as that reads out, assuming our underlying hypothesis is sound, which we do believe it is.

John Maraganore -- Chief Executive Officer

Great. And Barry, do you want to comment a little bit?

Barry Greene -- President

Yes. The only thing I'd add, and Pushkal, thanks for covering that so well, is as we know, ONPATTRO's currently indicated for the treatment of polyneuropathy in hereditary TTR patients. And as evidenced by the APOLLO study, we saw a stabilization and even a reversal of polyneuropathy in the majority of patients. So as Pushkal explained, we've got a number of endpoints in APOLLO-B that a profile similar to that will be very competitive, particularly an opportunity where we might see patients or aspects of disease getting better.

John Maraganore -- Chief Executive Officer

So Ritu, does that answer your question?

Ritu Baral -- Cowen -- Analyst

Yes. And so would all this together imply a potential reacceleration -- potential on positive data, potential reacceleration of growth in the 2021, 2022 time frame upon potential label expansion?

John Maraganore -- Chief Executive Officer

Well, yes, absolutely. We would expect that based on the opening up of the wild-type indication. Absolutely.

Ritu Baral -- Cowen -- Analyst

Thanks. Thanks for taking the questions.

Operator

Thank you. We will now move to our next question from Paul Matteis of Stifel. Please go ahead.

Paul Matteis -- Stifel -- Analyst

Great. Thanks so much for taking my questions. I had one follow-up to Ritu's question, and then one quick question on givosiran. To Ritu's question, I was wondering if you could just talk about APOLLO-B. And if you have any assumptions or any expectation for what you might see on mortality or hospitalization, understanding that cardiologists really care about outcomes data even more so than maybe neurologists in the TTR space. And then second, on givosiran, I totally understand that it's too early to give guidance.

I was wondering if I can just kind of bounce qualitatively off you what consensus seems to imply. It feels like analysts that cover Alnylam are assuming that this rollout will be a lot slower than ONPATTRO, and that this is a market that really requires a lot more building. I was wondering if you could speak to at least some agreement or disagreement with that assumption since consensus here really is a lot more conservative than what you accomplished in TTR.

John Maraganore -- Chief Executive Officer

Yes. Thanks, Paul. Great questions. So Pushkal, do you want to handle the first one; Barry, the second?

Pushkal Garg -- Chief Medical Officer

Absolutely. Thanks, Paul, for your questions. So I think what you're asking is really what our expectations were around the outcomes measures in the APOLLO-B study. And so maybe a couple of things. Again, the study was primarily powered around the 6-minute walk test. And the mortality and hospitalization endpoints are captured to secondaries and hierarchically tested there. I think in terms of context around that, I think if we look at the ATTR-ACT data as sort of an example and in a similar and related patient population, there we saw, with that drug, that hospitalization started to separate at around nine months and mortality differences started to emerge at around 18 months.

So by that token, a 12-month study, it's -- we have to see what it looks like. What is very encouraging to us, however, is that we did the post-hoc analysis out of the APOLLO study. And there, as you may recall from the data that were published in circulation, we started to see separation in these post-hoc analyses in the cardiac subpopulation relatively early in terms of mortality and recurrent hospitalization events. And that was in a subset of patients. And APOLLO was 225 patients. This is a 300-person study. So I think we are -- we obviously have included them because we're hopeful that we'll see those differences emerge, and we'll be capturing that in the context of the study.

John Maraganore -- Chief Executive Officer

Great. And Barry, on GIVLAARI.

Barry Greene -- President

Yes. On GIVLAARI, so, Paul, I'm not going to comment on what we're thinking relative to consensus. Of course, we're not giving that guidance. But qualitatively, we have a situation where we have a remarkable drug in GIVLAARI and a very unmet need here in a population desperate for treatment. But it is a market we need to build. We're moving this market from patients suffering a 13- to 15-year odyssey, the multiple inappropriate operations, to try to speed diagnosis, and a mentality from treating attacks to preventing and treating the holistic aspect of the disease. So it is a market in transition that we are really building on our own. They aren't the same competitive landscapes or the same dynamics we've seen in TTR. That said, we feel great about the start and where we're headed with building GIVLAARI into a very important medicine for these porphyria patients.

John Maraganore -- Chief Executive Officer

Great. Paul, does that answer your questions?

Paul Matteis -- Stifel -- Analyst

Yep. Thanks for the thoughts, guys. Appreciate it.

John Maraganore -- Chief Executive Officer

Thank you very much.

Operator

Thank you, we will now move to our next question from the line of Maury Raycroft of Jefferies. Please go ahead.

Maury Raycroft -- Jefferies -- Analyst

Good morning, everyone. And thanks for taking my question. I've got another one on ONPATTRO. I'm just wondering, for the launch, if you can provide more specifics on drivers for why doctors and patients are switching from stabilizers or deciding to add ONPATTRO onto stabilizers as combo. And then along these lines, how are doctors defining progression of disease while patients are on stabilizers? And is that definition evolving?

John Maraganore -- Chief Executive Officer

That's a great -- those are great questions, Maury. Barry, do you want to handle both?

Barry Greene -- President

Yes. So Maury, as we've talked about, the dynamics are different depending on what country. In general, in countries outside the United States, for hereditary TTR patients with polyneuropathy, ONPATTRO's being used frontline when patients are newly diagnosed, and they're being switched as patients progress. Progression's being defined differently across various physician groups. But in general, as we know from the ATTR-ACT study, all the patients progress. So it's not a question if they're going to progress, it's how quickly they progress. And as John highlighted appropriately, in the United States, given different indications and somewhat of the U.S. medical practice, we're seeing a bit of combination use. But that's a bit more of a U.S. dynamic.

John Maraganore -- Chief Executive Officer

Maury, does that answer your question?

Maury Raycroft -- Jefferies -- Analyst

Yes, that does. And any idea as to the proportion of patients that are getting combo use?

John Maraganore -- Chief Executive Officer

We don't have great numbers on that. We know that it's a double digit number for sure, maybe more over time, but we know some practices. In our R&D Day, we had a physician from the University of Chicago, a great institution, by the way, which -- where she has -- she said she has over 10 patients that are on combo use. So we do think this will increase. And physicians are finding that they're able to get the reimbursement for their ONPATTRO and as well as tafamidis if that's what they're using. And so that's good.

Maury Raycroft -- Jefferies -- Analyst

Got it. Thank you very much.

Operator

We will now move to our next question from the line of Anupam Rama of JPMorgan. Please go ahead.

Anupam Rama -- JPMorgan -- Analyst

Hey, guys, thanks so much for taking the question. Maybe following on Salveen's question earlier. Just thinking about the guidance, so what's that delta in sort of market dynamic that's assumed in achieving, say, the lower bound of $285 million versus the higher bound of about $315 million in the guidance? Is that layering on a couple of more countries? Is it increased penetration? Is it a combination of things? If you could give us a little more color on that, that'd be helpful.

John Maraganore -- Chief Executive Officer

Terrific. Jeff, do you want to handle that?

Jeff Poulton -- Chief Financial Officer

Well, I'll start, and then I'll let Barry comment. Again, the range that we've provided, $285 million to $315 million at midpoint, 80% growth. We understand the importance of achieving that guidance. We're confident in our ability to do so. We've provided a range, just like we had, with all the other elements of our guidance just given general uncertainties. That's all I have. Barry, anything further you want to comment on around that range for ONPATTRO?

Barry Greene -- President

Jeff, I think you covered it well. And just to emphasize, Anupam, we see growth coming from growth in countries where we have pricing and reimbursement with new patient finding and evidence generation, and then opening up in new countries where we achieved pricing and reimbursement. As I said earlier, it's going very, very well, and we believe it will continue throughout the course of this year into the years to come.

John Maraganore -- Chief Executive Officer

It probably didn't answer as much as you'd like, but just that's, I think, the color that we'd like to provide at this point.

Anupam Rama -- JPMorgan -- Analyst

Great, thanks for taking a question. Alright, thanks.

Operator

We will now take our next -- our final question today from Leland Gershell of Oppenheimer. Please go ahead.

Leland Gershell -- Oppenheimer -- Analyst

Hey, guys, thanks for taking my question. Just a financial question. Again, on the gross to net, I think you had said that you were meeting coming right in line with your sort of 25% between U.S. and EU. Is there any way you could break down if there's any differences in the gross to nets between those two regions? And then I have a follow-up.

John Maraganore -- Chief Executive Officer

Great. Jeff?

Jeff Poulton -- Chief Financial Officer

Yes, sure. The gross to net in the U.S. is approximately 20%. Outside the U.S., it's closer to 40%. The blend is 25%. All those figures were in line with our expectations for the year.

John Maraganore -- Chief Executive Officer

Al right. So you have follow-up, Leland?

Leland Gershell -- Oppenheimer -- Analyst

Oh, great. Thanks. And then just on -- just actually on inclisiran and the royalties. I think you had said that you'd do royalties up to about 20%, but those are scaled. Any color you can provide on what the scaling of those royalties is or just 20% is kind of the mix?

John Maraganore -- Chief Executive Officer

Well, the blend -- thanks for that, Leland. The blend is going to be in the high teens when you look at how the stack is structured and how the market potential for the product is expected to play out. And obviously, that gets higher and higher as the product meets expectations that Novartis is driving toward. So it's a very attractive share. I think one way to look at it is, just on an NPV basis, it's about 1/4 to 1/3 of the value alone of that asset depending on spend that is associated with ultimately driving the revenues. So that's a very significant portion of value that we have in the product. And we're obviously very pleased and excited to have Novartis as our partner for it. Jeff or Yvonne, anything to add to that?

Jeff Poulton -- Chief Financial Officer

I think you nailed it. I don't have anything to add.

Yvonne Greenstreet -- Chief Operating Officer

Nothing from me either.

John Maraganore -- Chief Executive Officer

Great. All right. Thanks, Leland.

Operator

Ladies and gentlemen, that's all the time we have today for questions. And now I would like to turn the call back to the company for any additional or closing remarks.

John Maraganore -- Chief Executive Officer

Well, great. Thanks, everybody, for joining us this morning for the call. We are really pleased with our R&D and commercial progress that we've been making. We're excited about where 2020 will take us, and we look forward to updating you in the weeks and months to come. Thanks very much.

Duration: 62 minutes

Call participants:

Christine Lindenboom -- Vice President of Investor Relations

John Maraganore -- Chief Executive Officer

Barry Greene -- President

Pushkal Garg -- Chief Medical Officer

Jeff Poulton -- Chief Financial Officer

Yvonne Greenstreet -- Chief Operating Officer

Emma -- Cantor Fitzgerald -- Analyst

David -- Barclays -- Analyst

Salveen Richter -- Goldman Sachs -- Analyst

David Lebowitz -- Morgan Stanley -- Analyst

Do Kim -- BMO Capital Markets -- Analyst

Ritu Baral -- Cowen -- Analyst

Paul Matteis -- Stifel -- Analyst

Maury Raycroft -- Jefferies -- Analyst

Anupam Rama -- JPMorgan -- Analyst

Leland Gershell -- Oppenheimer -- Analyst

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