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Amarin Corporation plc  (NASDAQ:AMRN)
Q1 2019 Earnings Call
May. 01, 2019, 7:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Amarin Corporation plc (NASDAQ:AMRN)
Q1 2019 Earnings Call
May. 01, 2019, 7:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Welcome to Amarin Corporation's conference call to discuss its Financial and Operating Results for the First Quarter of 2019. This conference call is being recorded today, May 1st, 2019.

I would like to turn the conference over to Elisabeth Schwartz, Senior Director of Investor Relations of Amarin. Please go ahead.

Elisabeth Schwartz -- Senior Director of Investor Relations and Corporate Communications

Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of Vascepa shipments and prescriptions, Vascepa product and licensing revenues, costs and other commercial metrics, gross margin, expenditures and adequacy of our financial resources, our current expectations for scientific presentations, publications, regulatory reviews and related timing thereof, our expectations that REDUCE-IT results could lead to a new treatment paradigm in the patient population studied, our plans and preparation for extended promotion of Vascepa and related market positioning and potential, our plans to purchase additional supply of Vascepa and our goals regarding the timing and scope of international expansion and our current plans for sales force and other commercial expansion.

These statements are based on information available to us today, May 1st, 2019. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into such as mergers, acquisitions, dispositions, joint ventures or any material agreements that we may enter into, amend or terminate.

For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-looking Statements section in today's press release and the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended March 31st, 2019. These documents have been filed with the SEC and are available through the Investor Relations section of our website at amarincorp.com. We encourage everyone to read these documents.

This call is intended for investors in Amarin and is not intended to promote the use of Vascepa outside its approved indication. Please note that that we are also providing slides to accompany this morning's call. These slides, which can be found on our website at amarincorp.com, in the Investor Relations section, under the sub category Events and Presentations, summarize some of the key updates discussed on today's call.

Finally, an archive of this call will be posted on the Amarin website, also in the Investor Relations section.

I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

John Thero -- President and Chief Executive Officer

Good morning, everyone. Thank you for joining us today. I look forward discussing Amarin's progress and outlook with you. Q1 was a very good quarter for Amarin. We made important progress in numerous areas, and we are confident that we will continue to execute on the strategy, plan, and goals we described in our last investor conference call. Our aim is not repeat all such matters in this call, but to focus on highlights in other update.

In this discussion, please note that despite the progress we made in Q1, we are still very early in the second of the four phases of commercialization that we described in our last investor conference call. In particular, we do not yet have an expanded label for Vascepa. As previously described, a broader label will facilitate broader product promotion. As listed in today's press release, Amarin's highlights from the first quarter of 2019 included a 67% increase in total net revenue, such revenue was $73.3 million in Q1 2019, compared to $43.9 million in the same period of last year.

Our submission on March 28 of a supplemental new drug application or sNDA to the US Food and Drug Administration seeking an expanded label for Vascepa based upon the positive results of the landmark REDUCE-IT cardiovascular outcome study. Scientific presentation and simultaneous publication of total event analysis from the REDUCE-IT study, which showed that Vascepa provided a statistically significant 30% risk reduction in total cardiovascular events compared to placebo in the statin-treated patient population studied in REDUCE-IT, demonstrating approximately one fewer major adverse cardiovascular event per six patients treated with Vascepa over a five-year period.

Medical treatment guideline updated by the American Diabetes Association based upon the results of the REDUCE-IT study recommending the icosapent ethyl be considered to reduce cardiovascular risk in primary and secondary prevention patients with statin controlled LDL cholesterol and cardiovascular risk factors of a nature studied in REDUCE-IT, including both primary and secondary prevention patients with triglyceride levels greater than or equal to 135 mgs per deciliter. As a reminder, Vascepa is the only form of icosapent ethyl, which is currently available.

While these are our most notable highlights from Q1, our progress was much broader. For example, we continue to add experienced employees that help support and accelerate our growth. And it is reassuring that we did not witness any visible setback from not extending our previous US co-promotion agreement. In addition, we are commercial partner for Canada. We announced earlier this week, regulatory submission was recently made to Health Canada seeking approval for Vascepa in Canada, based upon the result of REDUCE-IT, with such review granted priority review status by Health Canada. We want to thank our Canadian partner HLS for this noteworthy achievement.

Also, in Q1, we supported 13 scientific presentations and papers. As an aside, we added a new section to Amarin's corporate website at amarincorp.com, which describes the multifactorial mechanism of action, which appear to be associated with Vascepa in its unique active ingredient. This section includes numerous links to scientific papers. I encouraged those of you, who are interested in the science of Vascepa, to visit this new website section. Also, if you have not visited the Frequently Asked Questions section of our website, I encourage you to also review that section as we received many compliments from investors regarding the information presented in the FAQ discussions.

Our submission of the sNDA was a major undertaking. It consists of over 5 million pages of information reflecting over 35,000 patient years of study in patients who had multiple cardiovascular risk factors before being enrolled in the study. The size of this submission, while large, is not unusual for a clinical trial of this magnitude. The FDA acknowledged receipt of the sNDA submission. As is typical, the FDA has not yet communicated to Amarin the intended timing of its review. The FDA has a 60-day review period to determine whether the sNDA is complete and acceptable for filing. Pending such acceptance for filing, Amarin, unless and until it learns otherwise and communications from the FDA, is operating under the assumption that the sNDA will be reviewed on a standard review clock of 10 months resulting in a PDUFA date near the end of January 2020. Review timing is typically communicated by the FDA within 60 to 74 days of their receipt of an sNDA. Amarin is also operating under the assumption that there will be an FDA advisory committee or AdCom for this sNDA. As discussed in the past, there are many potential reasons for an AdCom, particularly given the large size of the US population that Vascepa could potentially address.

The sNDA we submitted, seeks a label for cardiovascular risk reduction consistent with the REDUCE-IT results. The details of such a label will be subject to negotiation between the FDA and Amarin. It would be counter-productive to such interactions with the FDA for us to publicly speculate on label details at this time. Similarly, it would be counterproductive for us to publicly discuss Amarin's interactions with the FDA through the review process.

If we learn specifics regarding matters such as the PDUFA date or the timing of an AdCom, we will move to promptly and publicly communicate such particulars. However, as is typical of companies with matters under FDA review, do not expect us to comment on ordinary course interaction pertaining to the sNDA review.

We have a very experienced clinical and regulatory affairs team at Amarin. This team is aided by experienced external advisors. As a reminder, REDUCE-IT was conducted under a special protocol assessment agreement with the FDA. The FDA was provided periodic updates regarding REDUCE-IT throughout the conduct of the study. The SPA for the REDUCE-IT study was reaffirmed by the FDA in 2016. We achieved the primary endpoint of the study with a very robust p value. Accordingly, while it is not possible for us to anticipate every potential inquiry which might be made by the FDA, we believe that the sNDA is well positioned for approval. Our confidence in these results is bolstered by the fact that REDUCE-IT results have been presented at two scientific congresses, AHA in November, and ACC in March, and that the results from REDUCE-IT have been presented at two peer-reviewed journals, The New England Journal of Medicine and the Journal of American College of Cardiology.

And of course, the track record of Vascepa extends beyond clinical trial as Vascepa has been prescribed over five million times since we launched Vascepa based upon its current indication. As a reminder, Vascepa achieved the primary endpoint of the REDUCE-IT study, demonstrating a statistically significant 25% placebo controlled risk reduction in the first occurrence of major adverse cardiovascular event, otherwise known as MACE, as well as statistically significant relative risk reductions in each component of the MACE composite, consisting of cardiovascular death, heart attack, stroke, coronary revascularization and hospitalization for unstable angina. For the primary endpoint, a clinically impactful number, needed to treat, of 21 was reported. This data was presented and published in November 2018.

On March 18, 2019 in a late-breaker presentation at the American College of Cardiology's 68th Annual Scientific Session, total events analysis was presented from the REDUCE-IT study. It is not uncommon for patients who survive one cardiovascular event to experience subsequent major adverse cardiovascular events.

Each adverse event is typically expensive, in terms of financial burden, pain and loss of productivity. The total event analysis showed that Vascepa reduced total event, that is first and subsequent event, by 30% compared to placebo over five years. This reflects that approximately one out of every six major cardiovascular adverse events over five years could be prevented by taking Vascepa versus placebo. Like the primary results presented in November, the total events results are unprecedented and have implications for both the patient and payor communities.

Cardiovascular disease is one of the most expensive areas in healthcare and the number one killer of American men and women. The results from REDUCE-IT support that the effects of Vascepa in reducing cardiovascular risk are relatively prompt, with notable separation identified after one year for the primary MACE composite endpoint and patients were treated with Vascepa, compared to similar patients in the placebo arm of the study.

And as shown in the study, the longer the Vascepa treated patients were followed, the greater the separation between the treatment effect on the Vascepa arm of the study compared to the placebo arm of the study. In other words, Vascepa helped patients avoid more primary cardiovascular events over time.

The revised guideline of the American Diabetes Association or ADA reflect the magnitude of the REDUCE-IT trial results. These new guideline issued in late March indicate that based upon the findings of REDUCE-IT in patients with atherosclerotic cardiovascular disease or other cardiac risk factors on statin with controlled LDL cholesterol, but elevated triglycerides, 135 to 499 mgs per deciliter, the addition of icosapent ethyl should be considered to reduce cardiovascular risk.

The revision of the ADA's guideline indicate a growing awareness and acceptance of icosapent ethyl, the active ingredient in placebo in the medical community by established and well regarded positions in society. We have observed that cardiologists and endocrinologists following the REDUCE-IT results have been quicker to start prescribing Vascepa than some other types of physicians. As cardiologists and endocrinologists are often the specialties on the forefront of cardiovascular and diabetes medical understanding in practice. This was encouraging.

We are aware that other medical societies are evaluating REDUCE-IT results. Some of the independent organizations have a history of updating their guideline only every five years. Given the important treatment implications of Vascepa beyond cholesterol management, we are urging such organizations to consider following the lead of the American Diabetes Association. However, we recognize that past guidelines from these societies have been subject to extended comment and review period such that we cannot predict the timing or content of such potential updates by these independent organizations. We are thankful that the ADA took such prompt action to advance patient care via their recent guideline update.

And yet another recognition of the tremendous results of the REDUCE-IT study and the benefits of Vascepa in preventing cardiovascular risk. Our Canadian partner received notification from Health Canada that priority review status was granted for Vascepa's application for Canadian approval that they submitted on April 26th of this year. Priority review status may be granted to regulatory filings in Canada for new treatment that potentially address serious life threatening conditions for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of that new treatment.

Under priority review, the performance target for the screening and review of the original submission is 215 calendar days versus 355 days for the standard review. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market assuming the product is ultimately approved by Health Canada. While we suspect that the US FDA is aware both of the updated treatment guidelines of the American Diabetes Association and the priority review decision from Health Canada, we do not know if such matters will impact their decision making or timeline.

Just as our medical affairs team is interacting with many medical society, they have also been active in making presentations of REDUCE-IT results to many managed care plan. Such presentations, of course, include the results of the REDUCE-IT study with qualification that the FDA has not yet reviewed such results. The presentations also include reminders of the failures of earlier generation therapies that demonstrate a positive effect in lowering cardiovascular event, as well as results from the various real world evidence study Amarin supported.

Such studies included results from databases at Kaiser and Optum, and more recently from the US Veterans Administration, which show that cardiovascular event rate and treatment costs are higher in patients with elevated triglyceride levels. In these managed care presentations, we also remind payors that while no other therapy has demonstrated the positive clinical results of Vascepa. Vascepa is priced below the cost of other new cardiovascular care therapies introduced in recent years. In such comments, we are not suggesting that Vascepa compete against such other therapies, but rather we are emphasizing that Vascepa has robust unprecedented clinical results available at an affordable price. We look forward to more formal pharmacoeconomic analysis likely to be completed and presented later this year.

While most of our contracting activities with payors are focused on insurance coverage for next year, because we are already contracting for 2019. We have seen some payors expand insurance coverage for Vascepa in 2019, with some others' payors promising to do so later this year. While these improvements for 2019 are relatively small increments to what was already broad insurance coverage for Vascepa. These are encouraging signs for the future as we work to ensure that Vascepa is available with coverage under all major insurance plan.

Mike Kalb, our CFO will comment in a moment regarding Amarin's Q1 financial results. Before he does so, I commend Amarin's new sales representatives and managers. It is inspiring to see them become proficient in describing Vascepa and encouraging already witnessed increased prescribing of Vascepa from positions upon whom they call. I came into 2019 with great confidence in our incumbent sales team members. These incumbent members continue as a group to perform well.

We are witnessing prescription growth from physicians who historically prescribed Vascepa, as well as from many physicians who are new to prescribing this important therapy. We are also experiencing growth broadly across the country including in areas, where until recently we didn't have any sales representation.

As discussed in our last investor conference call, following REDUCE-IT results we commenced the second of our four-phase plan in the US commercialization based upon Vascepa. The first phase of our commercialization was prior to our having outcome study results for Vascepa, during which time we devoted most of our resources to research and development and we had a small sales team. In the second phase, we more than doubled the size of our US based sales team and expanded the number of physicians we target with direct promotion of Vascepa. It is our aim to expand our promotion further following Vascepa label expansion including added direct consumer promotion. Currently our promotion to healthcare professionals is qualified. And our promotion to consumers is limited to discussion of triglyceride levels of greater than or equal to 500 mgs per deciliter. During the second phase we are not only interested in increasing Vascepa related education to support near-term increased Vascepa prescriptions.

We are also actively preparing for further commercial expansion in our anticipated third phase of commercialization, which is the phase following FDA approval of an expanded label for Vascepa. We're doing this by testing approaches to discover what works best. For example, we are piloting a small call center aimed at efficient outreach to position outside the scope of our current sales team. And we are also evaluating greater focus on diabetes practices. In addition, we continue to evaluate the potential impact of consumer promotion. While our consumer promotion is limited to our labeling or treating triglyceride levels greater than or equal to 500 mgs per deciliter. We will be evaluating the effects of consumer promotion at higher frequency in a small number of select geographical areas rather than running promotion with low frequency nationally.

As a reminder, based upon industry experience with other product, it generally requires at least five sales calls before most physicians change prescribing habit. For Vascepa, this may require fewer visits to some doctors due to the robustly positive REDUCE-IT results and the lack of an alternative proven treatment options to address the risk evaluated in REDUCE-IT. Conversely, it may also take more time for some doctors to begin prescribing Vascepa, as the label for Vascepa has not yet been expanded and because such doctors have not had a practice changing new therapy for preventative cardiovascular care in many years beyond therapies for cholesterol management and diabetes.

As of the end of March, consistent with previously communicated projection, Amarin sales representatives called on approximately 75% of our target physicians two or more times with the published results of the REDUCE-IT study. However, only slightly greater than half of these physicians had been called on three or more times. Feedback from physicians continues to be positive. They appreciate the unprecedented nature of the REDUCE-IT results. Change takes time, but we're making progress and we are optimistic about future growth. We have noticed that many previous no see doctors are now more accessible. We are also witnessing that various opinion leaders who seem to have limited interest in Vascepa prior to the REDUCE_IT results, now want to be speakers for purposes of educating other healthcare professionals about the benefits of prescribing Vascepa to the at-risk patients.

In addition, attendance has increased at the Vascepa Speaker programs in that Amarin Sponsored medical education programs regarding REDUCE-IT results. The recent addition of icosapent ethyl to the American Diabetes Association guidelines appears to be adding to this interest by physicians.

Outside of North America, we continue to make progress via our existing partners in China and the Middle East. In China clinical study of Vascepa continues. In the Middle East approval has been obtained in Lebanon and the United Arab Emirates. Work continues to get approval for Vascepa in other countries in that region.

With respect to Europe, our aim remains to submit for regulatory approval before the end of this year. We are working through such submission plan as well as through pricing analysis in other forms of market evaluation. As we have discussed in the past, while we have received expressions of interest from companies regarding European rights to Vascepa. We have not decided, whether who is best to partner in Europe before derisking the regulatory process or if it is better to wait. There are pros and cons to both approaches. Our near-term priority remain the US opportunity.

The opportunity for Vascepa in Europe appears to have improved recently as the European Medicines Agency or EMA confirmed that low doses of omega-3 fatty acid mixture products that contain DHA, as studied in recent outcome studies such as VITAL and ASCEND are not effective in preventing further heart problems after a heart attack. Such determination relegate EMA designation of such mixtures as only agents for lowering very high triglyceride levels without any indicated use for cardiovascular risk reduction.

As a reminder, Vascepa capsules are not an omega-3 mixture, but a drug product consisting of icosapent ethyl, the single active ingredient which has been shown to have clinical effects which are different from any other drug. Amarin remain at the forefront of the complex science of the varied effects of different omega-3 molecules in the application of such differences to cardiovascular risk reduction.

I now turn the discussion over to Mike Kalb, Mike.

Michael W. Kalb -- Senior Vice President and Chief Financial Officer

Thanks, John. As mentioned at the start of this call both our Form 10-Q and today's press release can be found on our website. They contain discussion of our first quarter financial results including some details which go beyond the highlights we will cover in this morning's call.

First quarter of 2019 showed significant gains and sales over the first quarter of 2018. Its volume driven gains occurred despite recurring seasonal headwinds caused by beginning of the year insurance deductibles as experienced by many people under their insurance coverage. Such deductibles which are not unique to Vascepa often cause patients not to fill all prescriptions near the beginning of each year, because they can't afford to pay the full insurance deductible all at once and as a result they forego filling certain prescriptions. Such headwinds appeared to have persisted in 2019. However, the refill rate was approximately 3% to 5% higher in Q1 2019 than in Q1 2018. Perhaps, motivated by the robustness of the REDUCE-IT clinical results.

Moreover, new prescriptions or NRxs of Vascepa in Q1 2019 increased approximately 80% compared to Q1 2018, based on data provided by Symphony Health. Such increase in new prescriptions of Vascepa powers the presentation and publication of results from the REDUCE-IT cardiovascular outcome study and following expansion of Amarin sales team, net of not extending the relationship with our prior call promotion partner.

Amarin's total revenue for the first quarter of 2019 was $73.3 million, compared to total revenue for the first quarter of 2018 of $43.9 million. Product revenue represents the vast majority of Amarin's total revenue. In the first quarter of 2019, net product revenue was $72.7 million, representing an increase of 66% over the same quarter of 2018. The core driver of this period-over-period increase was volume growth in Vascepa sales, supported by new and recurrent Vascepa prescriptions. The net selling price of Vascepa declined slightly in this period compared to the same period in 2018, due to an increased portion of the prescriptions in 2019, derived from patients with certain lower net paying Medicare insurance coverage.

The increases in the first quarter of 2019 were partially offset by a decline in channel inventory levels of Vascepa as reported to us by independent commercial wholesalers, such channel inventory levels at wholesalers were in the normal industry range for the beginning and end of the first quarter of 2019. But such levels regularly fluctuate. Calculated on a days-of-sales on hand basis, channel inventory levels also declined in the first quarter of 2018 (ph). We do not read any particular trend into such stocking levels. Often such changes relate to the timing of holidays and where the last day of a quarter falls within the workweek.

Had inventory levels at wholesalers remain consistent on a day-of-sales on hand basis from the end of December 2018 to the end of March 2019, new product revenues reported for Q1 2019 would have been higher by a few million dollars. We cannot predict whether these independent wholesalers will increase or decrease their Vascepa inventory levels going forward. In general, they appear to maintain such level at between 10 and 20 days of sales.

New product revenue in Q1 2019 increased faster than prescription growth reported by the leading independent sources of such data. Symphony and IQVIA data for Q1 2019 showed estimated increases in total prescriptions of 58% and 55% respectively over the same period of the prior year. As described more fully in Amarin's Quarterly Report on Form 10-Q, Amarin recognize its product revenue, when its customers consisting mostly of independent commercial distributors take possession of the product which they order from us and we ship to them. Amarin revenue is where not recognized when individual patients fill prescriptions.

In the three months ended March 31, 2019, based on product shipment information available to Amarin, it appears that Symphony Health and IQVIA, they have understated the percentage increase in Vascepa prescription levels. Symphony Health and IQVIA collect and report estimates of prescription information. There is a limited amount of information available to such companies to determine the actual number of total prescriptions for prescription products like Vascepa during such periods.

Data reported by Symphony Health and IQVIA is rarely identical. It is our understanding that their estimates are based on a combination of data received from pharmacies and other distributors, and historical and or estimated data when actual data is unavailable. Their calculations can be significantly affected by lags in data reporting from various sources or by changes in how pharmacies and other distributors provide data. Such methods can from time-to-time result in material inaccuracies in information when ultimately compared with actual results. These inaccuracies have historically been most prevalent and pronounced during periods of time of inflections upward or downward in rates of use. As such, the resulting conclusions from such sources should be viewed with caution.

Amarin cites such third-party information as a courtesy to its investors and because Amarin does not have direct access to prescription information.

The prescription levels reported above are based on information made available to us from third party resources and may be subject to adjustment and may overstate or understate actual prescriptions. For example, it is Amarin's understanding that in March and April 2019, Symphony Health had been working to fill gaps in data sources and that they may issue restated data at some point in the near future. Amarin is not directly aware of the details related to such sources or the precise timeline per corrective data or the degree to which the estimated Vascepa prescriptions as reported by Symphony Health may change upward or downward if such corrections are implemented.

Historically, the percentage change in prescription levels reported by these third-party sources have been relatively consistent with percentage changes and product shipment levels over extended periods of time. For example, over the course of a full year. However, the absolute prescription levels reported by these sources do not appear to ever directly match each other or the level of product shipments.

We continue to guide $350 million as our estimate of net revenue for 2019. This amount reflects an increase of greater than 50% over 2018 results. Such guidance assumes that the approved label for Vascepa is not expanded by the FDA during 2019. While we are encouraged by our progress in Q1, we remain very early in our promotion of a Vascepa, and we have witnessed quarterly variability in the past. We are proud that our revenue growth in Q1, 2019 exceeded 50% growth over Q1, 2018, but we also note that Q1, 2018 results were by far the lowest results from last year and that our hurdles ahead are high. While we are confident in our outlook, we believe that our prior guidance remains the most appropriate.

In addition to net product revenue, we recognized licensing revenue of $0.5 million and $100,000 in the three months ended March 31, 2019 and 2018 respectively related to agreements for the commercialization of the Vascepa outside the United States. Gross margin from product revenues was 76% in the first quarter of 2019. Selling, general and administrative or SG&A expenses for Q1, 2019 and 2018 were $71.6 million and $43.4 million respectively. The increase in SG&A expenses primarily reflects an increase in sales and marketing expenses, which include expenditures for expansion given our successful REDUCE-IT results.

As a reminder we grew our field sales force from about 150 representatives for most of 2018 to about 400 in 2019. Research and development expenses for Q1 2019 and 2018 were $7.2 million and $11.8 million respectively. This decrease was primarily driven by a decrease in REDUCE-IT related costs following the successful completion of the REDUCE-IT trial. R&D cost consisted primarily of clinical trial wrap up activities, costs related to scientific publications, and preparing for the sNDA submission, which occurred on March 28, 2019.

Under US GAAP, Amarin reported a net loss of $24.4 million in the first quarter of 2019, or basic and diluted loss per share of $0.07. This net loss included $6.9 million in non-cash stock-based compensation expense. Amarin reported a net loss of $24.1 million in the first quarter of 2018, or basic and diluted loss per share of $0.08. This net loss included $3.8 million in non-cash stock-based compensation expense. Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net loss was $17.5 million for the first quarter of 2019, or non-GAAP adjusted basic and diluted loss per share of $0.05 compared to non-GAAP adjusted net loss of $20.3 million for the first quarter of 2018, or non-GAAP adjusted basic and diluted loss per share of $0.07.

As of March 31, 2019, Amarin reported cash and cash equivalents of $211.1 million, net accounts receivable of $79.5 million and $57.9 million in inventory. In connection with the recently adopted leased standard, the Company recorded an operating lease right-of-use asset, and corresponding operating lease liability each of approximately $9 million.

As of March 31, 2019, Amarin had approximately 330.6 million American Depository Shares, and ordinary shares outstanding, 28.9 million common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 16.8 million equivalent shares underlying stock options at a weighted average exercise price of $5.51, as well as 9.3 million equivalent shares underlying restricted or deferred stock units.

I will now turn the call back over to John for closing remarks. John?

John Thero -- President and Chief Executive Officer

Thank you, Mike. Amarin's General Meeting of shareholders is scheduled for May 20th in Dublin. As reflected in our recently filed proxy statement, we anticipate that this will be a relatively straightforward meeting. The proposals set forth by our Board of Directors are for ordinary or recurring matters. Each such resolution is intended to support Amarin's growth going forward. We hope that all of our investors support us in such matters and I thank you in advance for your support.

Before beginning the Q-and-A portion of this call, let me respond to a line of questioning that we hear periodically regarding our ongoing ANDA litigation. Our patents expire in 2030, the public record for the ANDA litigation is available for all to view and many have. As a reminder, there are two ANDA filers that remain in the litigation from the original four. Apotex determined to not litigate in the case early on in the proceeding. Rather than continue to litigate, Teva settled with us, to enter in August of 2029. There is no IPR proceeding, that is inter parties review in that case. The statutory one-year window for IPRs from the end of filers on the relevant patent has expired.

While court schedules can change, current timing suggest that this matter, assuming it is not settled, would go to trial in early 2020. We continue to defend our patents vigorously. We don't plan to comment further regarding ongoing litigation beyond the above.

With that we conclude our prepared comments, and we'd like to open the line to some questions. Operator?

Questions and Answers:

Operator

Thank you. At this time we'll be conducting a Question-and-Answer session. (Operator Instructions) Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Louise Chen -- Cantor Fitzgerald & Co -- Analyst

Hi. Thanks for taking my questions, and congratulations on a strong quarter. I had a few questions here. So with respect to your prior guidance of $350 million for the year, I didn't hear that you had updated that. Just curious if that is the guidance that we should still adhere to, as we model for the rest of the year going forward? So any color on that would be helpful.

Secondly, with respect to Vascepa, do you -- are you looking to file any additional patents given the good results of the REDUCE-IT study?

And then third question I had, I get this question a lot, was on how proprietary your supply chain is? And if that's a competitive advantage for you? Thank you.

John Thero -- President and Chief Executive Officer

Louise, it's John. Good morning. Thanks for the nice comments. With respect to guidance, we're still very early here in the launch. We talked about our sales reps being out to most to the targets for in that two to three time range. We're pleased that our growth in the first quarter exceeded 50%. Last year's first quarter was the lowest of the quarters for the year. The hurdles get higher as we go forward. We've not changed our revenue guidance for the year. That guidance does assume that as we expect a standard 10-month review clock for our sNDA filing. Were that to change, I'm not suggesting it would, but were that to change, we could revisit guidance at that point. But at this point we are not changed. We have not changed the guidance for revenues for the year.

With respect to supply, the manufacture of Vascepa is very difficult. The -- we've scoured the world trying to find the best suppliers. We work with companies. It's numbers of them have failed on early attempts to manufacture Vascepa. We know that when there was a generic Lovaza that came into market, there were manufacturing issues at the beginning. So we are -- we do think that being able to produce this difficult-to- manufacture product and to be able to produce it, cost effectively is important. And we are using the capacity of our suppliers pretty completely at this point in time. We've not updated yet our guidance relative to our overall capacity. But we are working towards what could be a doubling or tripling of that potential overall capacity. The earliest plans therefore, being more definitively in place before the end of this year. So I do think it is a competitive advantage and those suppliers are beholden to us.

With respect to patents, we have submitted a number of patents off of the REDUCE-IT results. This is the first ever study in a important population. We do believe that there were surprising and unexpected findings in which we've had -- file spend. We have had some patents granted to us based upon outcomes for treatment of this patient population. But there are additional patents on file and our experienced IP team continues to scour the data and look for further patents. There’s actually quite a few of them. So I'm not going to go through them all and particularly not the ones that haven't granted, but – but yes, lots of patents.

Louise Chen -- Cantor Fitzgerald & Co -- Analyst

Okay. Can I just have a quick follow-up. Thank you for that. On the guidance question, so I guess to me it sounds like you're being a little bit conservative, given where the script trends are headed and the fact that there were some offsets even in the good script trend in the first quarter. So any color from that front? If you don't want to comment, it's fine, but I'm just asking , because it just seems like the $350 million probably is going to come in low relative to where the scripts are headed? Thank you.

John Thero -- President and Chief Executive Officer

Yeah. Growing any business when you don't yet have label expansion and we're restricted with regard to what we're talking about. Growing something by greater than 50%, we think is a sizable number. I like your optimism, but we're really early and still in what we're doing and like a little more of a runway here before we would reach a similar degree of optimism. So I know our sales force is out there, they're getting terrific feedback from customers, but these docs haven't had a practice changing new therapy in a long time. And while they appreciate the data for REDUCE-IT, how quickly they implement this for their patients and how broadly they implement this for their patients, still a lot of unknowns out there. And if we compare our growth after outcomes data to the growth that we've seen, for example, some of the diabetes medicines and PCSK-9s etc., we're sort of out and ahead of the pack on that. So I don't want to get it too far out over our skis, particularly in that we don't yet have a label. So I hope you're right, but it's still early.

Louise Chen -- Cantor Fitzgerald & Co -- Analyst

Okay. Thank you.

Operator

Thank you. Our next question comes from the line of Joel Beatty with Citi. Please proceed with your question.

Joel Beatty -- Citigroup -- Analyst

Hi. Good morning. Thanks for taking the questions. The first question is on the script count. Could you comment on how accurate you believe the Q1 script counts are? And I've realized that you believe the growth rate was understated, but get curious on the absolute level?

And then second question is on net pricing, could you comment on how that changed, if any in Q1 compared to Q4 of last year? Thanks.

John Thero -- President and Chief Executive Officer

So on the script count, as Mike has already provided a lot of comment there. I'll jump in and then I'll let Mike talk about net price. I don't think the scripts are even spot on. The fact that the two leading providers of script data don't agree with each other ever, sort of suggests that they're not spot on. On an annual basis, in terms of percentage change, they've been pretty good on a quarterly basis. They've been off almost every quarter and sometimes they overshoot, sometimes they undershoot. And that over, under-shooting tends to be exacerbated during periods of inflection. And we think that they were under in the fourth quarter, we think they are under in the first quarter based upon what we've seen from a shipment's perspective. They use sampling techniques. This is information. We don't have specific information on what the real prescription levels are. So we look to their data with interest as well. It's the best of what exists, but I think it should all be viewed with sort of that perspective in mind, that it is a combination of some real data and some sampling.

And at least, I think in the first quarter we grew up a bit differently than what they sort of indicated. So absolute numbers, I don't look at them all that reliably, but on a percentage basis over a longer period time, I think they become more reliable. And as Mike commented, particularly on Symphony Health, they have disclosed that they had some data reporting issues in the first quarter, or not sure that through all of that. At this point in time, I'm sure they've done their best in terms of making estimates based upon the information they have, but even they are commenting of their data wasn’t up to their usual standards for the first quarter. With respect to net price, Mike, do you want to jump in?

Michael W. Kalb -- Senior Vice President and Chief Financial Officer

Sure. Thank you, John. And thanks for the question, Joel. Net selling price, as we mentioned in this quarter, has decreased slightly due to an increased portion of the Vascepa prescriptions in 2019, coming from a Medicare insurance coverage. If we look at Q1 '19 compared to full year '18, we’re fairly flat, down compared to Q1 '18 as we mentioned. That's kind of what we've said repeatedly, quarter-on-quarter, year-on-year, as compared to Q4 '18, which I think was the question, it’s roughly flat, down just a drop.

Joel Beatty -- Citigroup -- Analyst

Got it. Thanks. And maybe one other question on the payor approval rates. I wonder if they've changed at all in Q1 due to either seasonal aspects or due -- related to scrip growth?

John Thero -- President and Chief Executive Officer

Joel, so some of that data, we don't get fully, it’s a little bit delayed. But based upon the data we've seen, we didn't see any particular change in terms of the payor approval rate. As we've talked about, I think that there are beginning of the year insurance deductibles which are not Vascepa specific, they're patient specific that do have some influence over the rate at which patients fill prescriptions. And we did see the rate at which patients filled prescriptions in the first quarter of this year be a little bit higher than what we saw in the first quarter of last year. But on the payor side, I didn't see any real change in the approval rates, nor would I've expected any major change in that regard.

Joel Beatty -- Citigroup -- Analyst

Great. Thanks and congrats on the revenue growth.

John Thero -- President and Chief Executive Officer

Thank you.

Operator

Thank you. (Operator Instructions) Our next question comes from the line of Michael Yee with Jefferies. Please proceed with your question.

Michael Yee -- Jefferies -- Analyst

Hey, thanks. Couple of questions as well. I know that a lot of people asking questions around the scripts. I mean, I guess I would just like to confirm and clarify that if you reported $77 million in the fourth quarter and $73 million in the first quarter, that the delta there would have been inventory and that if scripts were up so much in Q1, 15% or 16% or so, I guess your true demand sales in the first quarter would've been high 80s or 80-ish. Maybe you could clarify that for us if your same script direction underrepresented? So just trying to triangulate that.

And the second question was on Europe. I mean, I guess, how are you thinking about the different push pull factors as you think about that through the course of the year? And how important or just keeping wholly owned rates for this asset for as long as possible? Thanks so much.

John Thero -- President and Chief Executive Officer

You might appreciate the comments, and just an overall comment. Operator and others are in the queue, I guess I probably talked a bit long here. You are right, back to the (ph) comments and promised people we try to keep this to an hour. So I apologize if I won't get your questions from other people, but do follow up. We do it forward of following up with people separately. With regarding prescriptions, we continue to advise that the best way to look at our business really is year-over-year as opposed to on a consecutive quarter basis due to the seasonal effects. That being said, we have experienced some channel inventory fluctuations, all of which have been in the sort of ordinary course, and the people aren't as familiar with this wholesaler is -- or in chunks and they change their ordering pattern sometimes based upon where holidays fall, based upon where the end of a quarter falls, based upon where weakest things are delivered in or not delivered in, and our inventories sort of been in the, what we've consider the normal range, but that tends to vary up and down.

If you were to, and I think this is what you're trying to get to, if you were to adjust our for estimates of channel inventory in the fourth quarter and the first quarter, you could argue that the first quarter was actually slightly up versus the fourth quarter. But I don't think that that's -- that I appreciate your curiosity on that topic, but I really do think that because of the seasonal effect, that it's a stronger way to look at or a more valid way to look at it on a year-over-year as opposed to consecutive quarter basis. But I hope those comments are helpful on that.

With respect to the EU, our priority has been to make sure we do the US process right and that has been consuming here with regard to the -- to a very large submission we sent in to the FDA, and unfortunately the -- our partners in Canada were able to piggyback that one pretty directly. Europe is a bit more complicated. There are a number of considerations there, country by country, and EU overall, there is also a different role from a regulatory side, and from a pricing side, and we are increasingly turning our attention to that. Now that with the submission is filed in the US, and we've got a little bit of a window here, before we are likely hear back from the FDA at the 60 to 74-day time frame. So we're using some of that time to advance of our planning for an EU filing. And we'll continue to use those opportunities, where we have lags in the US priority to advance the European opportunity. We have described that. Yeah, there are pros and cons to whether we would partner in Europe sooner versus later. Pros are that if having a substantial partner provides clarity on that pathway, (inaudible) Board probably provides monies up front, and they would argue that they would provide regulatory experience as well, that we're working with a very experienced regulatory team in Europe already. So I'm not sure how much would be added there.

But the flip side is that you tend to get paid less when there's still risk and if work can be risked at, you might get better terms later and not being aligned with one party for Europe gives us greater flexibility for something that might be done more broadly in other parts of the world. So those pros and cons we are considering, but again our priority has been the US opportunity. We think that's -- Europe is a significant opportunity, but the US opportunity is our priority, we believe the largest opportunity for the product and the one that we have to get right. So that's where we are at the moment.

Hopefully those comments were helpful. It is 8:30 East Coast. I appreciate all the interest here. We look forward to continuing to provide updates on our progress. Again I think Q1 was a good quarter, but we're just getting started, and we've made progress in a lot of areas and we look forward to much more as the year goes on. So we thank you very much.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Duration: 62 minutes

Call participants:

Elisabeth Schwartz -- Senior Director of Investor Relations and Corporate Communications

John Thero -- President and Chief Executive Officer

Michael W. Kalb -- Senior Vice President and Chief Financial Officer

Louise Chen -- Cantor Fitzgerald & Co -- Analyst

Joel Beatty -- Citigroup -- Analyst

Michael Yee -- Jefferies -- Analyst

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