Nabriva Therapeutics plc (NBRV) CEO Theodore Schroeder on Q3 2021 Results - Earnings Call Transcript

Nov. 09, 2021 8:40 PM ETNabriva Therapeutics plc (NBRV)
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Nabriva Therapeutics plc (NASDAQ:NBRV) Q3 2021 Results Conference Call November 9, 2021 4:30 PM ET

Company Participants

Theodore Schroeder - Chief Executive Officer

Dan Dolan - Chief Financial Officer

Steve Gelone - President and Chief Operating Officer

Conference Call Participants

Carl Byrnes - Northland Securities

Suji Jeong - Jefferies

Operator

Good day and thank you for standing by. Welcome to the Nabriva Therapeutics Third Quarter 2021 Business Update and Financial Results Call. At this time, all participants are in a listen-only mode. After the speaker presentation there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Mr. Dan Dolan, Nabriva’s, Chief Financial Officer.

Dan Dolan

Thank you, and good afternoon, everyone. Welcome to the Nabriva’s conference call and webcast where we will discuss the third quarter 2021 earnings and also provide a business update. The Slides for today's presentation are posted on the Company’s website, www.nabriva.com, and can be found under the Investors tab in the Events & Presentations section. We recommend that you refer to the presentation as we will be using those slides for today's discussion.

Before we begin on Slide 2, I would like to remind everyone that this conference call and webcast will contain Forward-Looking Statements about the Company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of the date of this call. We will undertake no obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes could differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and our other periodic reports on Forms 10-Q and 8-K filed with the SEC.

Turning to Slide 3, I would like to briefly run through this afternoon's agenda. Ted Schroeder, Nabriva's CEO, will start with a business update, and will present an overview of the commercial highlights from the quarter. Steve Gelone, Nabriva’s, President and COO will then give an update on the Lefamulin and the prospects for the Lefamulin’s life cycle management. Lastly, I will provide a financial review before Ted comes back with some summary comments and leads a Q&A session.

I would like to now turn the call over to Nabriva’s Chief Executive Officer, Ted Schroeder.

Theodore Schroeder

Thank you, Dan, and thanks to everyone joining our call this afternoon. Before I get started, I would like first to welcome Dr. Chirstine Guico-Pabia who joined Nabriva as our Chief Medical Officer in October.

Dr. Guico-Pabia brings over 30-years of global bio-pharmaceutical experience and extensive expertise in every stage of drug development, including pharmacoeconomics and outcomes, research and medical affairs. She has previously held leadership positions at small startups and large multinational companies, including McKesson, Merck, Wyatt, Pfizer and Metagenics. Welcome again, Christine.

Let's start on Slide 5. We are very pleased with our results this quarter, and the progress we are making on multiple fronts. SIVEXTRO’s performance was strong, recording double-digit quarter-over-quarter growth in both net sales and in TRx.

These figures are promising and give us increased confidence that our commercial efforts are having an impact. As mentioned in previous updates, we expect to get SIVEXTRO’s sales back to historical peak sales trends by mid 2022.

To help our efforts in increasing awareness of both XENLETA and SIVEXTRO, we recently launched an inside sales representatives program, which has supplemented our field-based team to expand the promotional reach of SIVEXTRO and XENLETA. We believe this additional program will expand our reach by targeting an estimated 2000 top prescribers in white space geographies through additional personal promotion.

Moving to XENLETA. We recently announced an agreement with Vizient, the largest healthcare performance improvement company in the U.S. to expand access to XENLETA in the hospital setting.

For those that are not aware, Vizient provides expertise, analytic and advisory services, as well as a contract portfolio that represents more than 110 billion in annual purchasing volume to improve patient outcomes and lower costs.

With approximately three million people treated for Community Acquired Bacterial Pneumonia or CABP in the hospital setting each year, we believe this partnership is a great step toward establishing XENLETA as a treatment option for CABP in the hospital setting.

In September, we also announced the approval of XENLETA in Taiwan. As many of you, know XENLETA has received regulatory approval in every country in which we have filed a regulatory application.

We continue to see additional opportunity for growth for XENLETA through geographic expansion. We recently renegotiated our agreement with Hovione by extending our strategic partnership with Hovione through 2030, we gained near-term flexibility in cash allocation.

We can now deploy additional investments towards growth driving initiatives, such as the increased advertising, non-promotion and direct to patient initiatives as we are entering the CABP season.

Earlier this month, we published the first data demonstrating the potent anti-inflammatory properties of lefamulin. We are encouraged by these data and the potential that an agent combining anti-bacterial and anti-inflammatory properties may offer clinicians and patients. Steve will provide additional color on these important data later in the presentation.

As a result of the celebrating revenue growth and continuing to be prudent with our resource deployment, we have now extended our cash runway to substantially through the second quarter of 2022.

Moving to Slide 7. This graph shows the TRx for their oral antibiotic market in the United States. As you can see, the current trajectory is trending positively towards a return to pre-pandemic antibiotic prescribing.

The trend is encouraging and while not back to pre-pandemic levels, we are seeing consistent upward prescription growth overall. This is promising especially for XENLETA as we head into the fall and winter season, when we typically expect to see a greater incidence of respiratory infections.

Looking specifically at SIVEXTRO on Slide 8. I’m excited to announce that SIVEXTRO hit the 1000 prescription mark this quarter. The first quarter this has been achieved since the second quarter of 2020.

Additionally, we are excited to report a quarter-over-quarter growth demonstrated by SIVEXTRO, with a 14% sequential increase. We remain confident that SIVEXTRO sales can reach historical peak sales levels by mid-2022.

Some of the factors responsible for the strength include the increased product awareness, the rate of MRSA infections in the community and the productivity of our salesforce. The outstanding coverage for SIVEXTRO was another factor driving adoption.

We currently have approximately 275 million lives in the U.S. covered for SIVEXTRO. Our field-based sales representatives continued to see a high level of in-office interactions, as we have progressed throughout the year.

Not only are these increased office visits good for the current growth at SIVEXTRO, but we also believe this is laying the groundwork ahead of the CABP season by keeping them XENLETA top of mind.

Moving to Slide 9, let me spend the next few minutes discussing our agreement with Vizient, which we signed in early September to make XENLETA available to Vizient’s Pharmacy Network program.

Vizient is the largest healthcare performance improvement company in the US. Vizient’s customer base includes 18 networks and approximately 340 health systems, which represents an opportunity to focus on improving patient outcomes.

Our partnership will afford us access to Vizient’s expertise, analytics and advisory services. With approximately three million adults treated with CABP in the hospital setting annually, this represents a significant opportunity to efficiently expand the use XENLETA overtime.

Slide 10 lays out some of the key benefits that this relationship will bring to XENLETA. Given the recent challenges of getting access to hospitals due to COVID restrictions, we believe that we have created a channel through Vizient to expand the awareness and presence XENLETA in the hospital setting.

As we have previously mentioned, we were optimistic that XENLETA will be recognized as a promising therapeutic for CABP with its novel mechanism of action, short course of therapy, low propensity to develop bacterial resistance and favorable safety profile.

What is also important about the Vizient agreement is the opportunity to expand XENLETA usage in the transition of care scenario, when a CABP patient goes from the hospital to the outpatient setting.

Last winter, we experienced the season of drastically reduced respiratory infections. But we anticipate that as people continue to resume normal activities, it is reasonable to expect a rise in the number of patients seeking treatment this fall and winter. We are envisioning the patient will start therapy while they are in the hospital and then get an additional prescriptions take home upon discharge.

Slide 11 highlights some additional efforts we are employing to promote XENLETA and drive increased demand in Q4 to capitalize on the respiratory season. These efforts focused on expanding prescriber rates through brand messaging at the point of CABP diagnosis.

Generating highly qualified leads to sales representatives from non-personal efforts, identifying local and regional medical congresses for the sales representatives to engage with prescribers beyond the office and the introduction of the 10-Count Oral Pack or X Pack for improved patient access and convenience.

We are also focused on activating targeted patients by developing a XENLETA patient destination and content repository. Doctor discussion guides, leave behind with key messages and leveraging website drivers to reach the most likely CABP patients.

As we turn to Slide 12, we are excited to announce for watching our 10-Count Oral Pack or X Pack for XENLETA. The availability of a 10-Count Oral Pack allows for an efficient option for pharmacies to carry XENLETA across their distribution networks.

As a result, we believe this will enhance, the overall patient experience by improving access and availability of XENLETA across the retail market. Our salesforce will actively communicate the availability of a 10-Count Oral Pack, which we believe provides another positive step for XENLETA, as we enter the upcoming CABP season.

With that as the commercial update, I will now pass the call over to Steve Gelone, who can discuss the progress and with lefamulin in cystic fibrosis and the recent promising data showing the lefamulin’s anti-inflammatory activity. Steve.

Steve Gelone

Thank you, Ted, and it is my pleasure to provide a brief update on some of the ongoing XENLETA life cycle management activities. As we have previously disclosed, Nabriva is evaluating the potential of XENLETA and the management of bacterial exacerbations caused by [Staphaureus] (Ph) in patients with cystic fibrosis.

As a reminder, and to help frame the unmet medical need, Slide 14 depicts the most recent data from the cystic fibrosis foundation patient registry report from 2019, showing the Staphaureus remains the most common respiratory pathogen identified in patients with CF, even after the introduction of CFTR modulator therapy.

Importantly, as shown on the right side of the slide, the presence of Methicillin resistant or Staphaureus MRSA in a respiratory tract culture negatively impacts the median survival time in CF patients with an observed reduction of 6.2 years, as compared to CF patients with a respiratory culture that is negative for MRSA.

While clinicians have a number of anti staphylococcal antibiotics in their treatment armamentarium, they have had to rely upon agents that have either not been demonstrated to be reliably effective for the treatment of MRSA that require intravenous administration in order to be effective or has significant safety and tolerability issues limiting their clinical utility.

Given that XENLETA it is available as both an oral and intravenous formulation has been shown to be a potent MRSA agent and is well tolerated. We believe it may provide an attractive treatment option for this difficult to treat patient population.

Slide 15 provides an overview of the multifaceted approach we are taking to demonstrate the potential clinical utility of XENLETA in patients with CF. In collaboration with experts in the field, we have identified the most important challenge is present in treating exacerbations in patients with CF, including that this patient population is often heavily pretreated with antibiotics, placing them at increased risk for the presence of resistance to many existing antibacterial classes.

That these patients have a unique inflammatory environment present in their lungs, and that they take concomitant medications that may pose potential drug, drug interactions. As we constructed our approach to optimize the key attributes of XENLETA.

For example, we have demonstrated the potent anti-staphylococcal activity of XENLETA against Staphylococcus Aureus isolated from CF patients. And if completed modeling the potential for drug, drug interactions with the most commonly prescribed CFTR modulators.

Additional ongoing work, will describe the efficacy of the lefamulin in CF mouse infection models. And we are on track to dose the first patient in our Phase I study evaluating the safety and pharmacokinetics in XENLETA in patients with CF in the first quarter of 2022. We are very excited to be working with many of the world's experts on this program and are anxious to continue to share our progress with the scientific community over the coming months.

In addition to our ongoing work to further describe XENLETA's direct acting antibacterial effects, we have recently published results that demonstrates XENLETA also possess potent anti-inflammatory and immunomodulatory properties, in the journal Plus One.

In two different animal models of lung inflammation. One simulating acute respiratory distress, similar to that caused by the SARS-CoV-2 virus and another caused by the H1N1 strain of influenza virus also known as the swine flu that caused the pandemic in 2009.

XENLETA was shown to reduce the number of neutrophils, which are specific kind of white blood cell that get recruited into lung of these animals. It inhibited the production of pro-inflammatory cytokines, including TNF alpha and interleukin IV that has been associated with poor outcomes in patients with pneumonia. It reduced LDL inflammation and lung consolidation. And importantly was shown to increased survival rate in animals infected with the H1N1 influenza virus.

XENLETA's activity was notably shown to be similar to that observed with dexamethazone, a known potent anti-inflammatory corticosteroid, and superior to azithromycin a macro antibacterial agents that is commonly used for its anti-inflammatory activity.

With grant support from the Austrian Research Promotion Agency, our team is advancing work designed to elucidate the potential mechanism of action of XENLETA's anti-inflammatory and immunomodulatory effects, as well as to validate these effects in-vivo disease specific models that will help to guide potential future clinical applications, such as the treatment of acute respiratory tract infections, bacterial exacerbations of cystic fibrosis, auto-immune conditions and fibrotic diseases. We look forward to the next steps and it is important projects tend to providing updates on our progress.

It is now my pleasure to turn the presentation over to my colleague, Dan Dolan, who will provide Nabriva's corporate financial level. Dan.

Dan Dolan

Thank you. If you turn the Slide 18, I would like to touch on some key highlights for the third quarter of 2021. Total revenues of $8.9 million grew 8% sequentially versus the second quarter of 2021.

This was primarily driven by SIVEXTRO net product sales sequential growth of over 14% versus the second quarter of 2021. Revenue also includes $1 million in collaboration revenue and grant funding from the Austrian Government.

Within the third quarter results, we recorded a special return to serve adjustment for the shelf life expiration of the initial launch of bottles of XENLETA, which had three year dating. With the newly available 10-Count Oral Pack, which will have four year dating, we anticipate wholesalers will replenish some of the soon to be expiring product with this new 10-Count Oral Pack.

During the third quarter, we continue to focus on disciplined balance sheet management, as we renegotiated our supply agreement with Hovione the API manufacturer for XENLETA. The amended agreement provides for near-term cash flexibility, easing the amount of cash we need to allocate towards inventory and allowing us to put more cash to work behind growth initiatives for both XENLETA and SIVEXTRO.

We also entered into an equity line of credit agreement with Lincoln Park Capital, which provides an efficient option to access capital at our discretion over the course of the next two years. We will continue to maintain a laser-focus on our cash allocation strategy, driving efficiencies in our operating expense mix to ensure we are maximizing our investment, while driving commercial execution and revenue growth. We exited the quarter with cash and cash equivalents of approximately $52 million, providing us cash run was substantially through the second quarter of 2022.

Moving on to Slide 19, we look at our P&L for the three months ended September 30, 2021 versus the same period for 2020. We experienced significant year-on-year growth on our top-line revenues driven by net product sales of SIVEXTRO, as well as the recognition of collaboration revenue upon the achievement of milestones from our Chinese partner.

You will see that our cost of sales increased approximately $4.2 million versus the prior year driven by supply purchases of SIVEXTRO. This was in line with our expectations around how the P&L would evolve following the launch of our own NDC for SIVEXTRO in the second quarter of 2021.

The increase of approximately $1.3 million in SG&A reflects a full quarter run rate of our community-based sales representatives compared to a scale back run rate in our commercial efforts during Q3 of 2020, resulting from the initial impact of COVID-19.

Our net operating loss showed improvement year-on-year, highlighting the impact of SIVEXTRO on the shape of our P&L and highlighting the scalability of our commercial infrastructure to drive operating leverage.

Turning to Slide 20. We take a look at our balance sheet as of September 30, 2021. As mentioned earlier, our cash and cash equivalents at the end of the quarter were approximately $52 million, an increase of approximately $11 million from December 31, 2020, driven primarily by activity in our ATM during the second quarter of 2021. This was offset by operating cash burn, which included SIVEXTRO supply purchases in the quarter.

The increase in accounts receivable can be attributed to the timing of cash receipts due from our wholesale is on sale of SIVEXTRO. As we pivot our attention to the liability section, you will notice that we continue to carry a minimal amount of debt, maintaining focus on our continued commitment towards discipline balance sheet management.

If you can now turn to Slide 21, I would like to take some time to highlight the impact that the launch of Nabriva’s own SIVEXTRO NDC has on the shape of our P&L as well as some of the work we have done recently to maximize cash flow has had on our operating cash burn.

In April of 2021, we moved from a model of receiving a percentage royalty from sales of Mertz, NDCs of SIVEXTRO, pivoting to launching our own Nabriva NDCs of SIVEXTRO realizing the full benefit of net sales in our reported revenues. You will see on the chart, the step down in operating cash burn, this provided to Nabriva from the first quarter of 2021 to the second quarter of 2021.

In the third quarter, we saw the impact of how SIVEXTRO net product sells showing double digit growth compared to the second quarter, further improving our operating cash burn. As you see on the chart, total revenues increased 8% versus Q2 of 2021, and operating expenses remained consistent with Q2 of 2021.

This evolution in the revenue composition on the P&L for Nabriva provides increased profit margins and improved operating leverage. This operating leverage coupled with our recent revision in our supply agreements with Hovione for XENLETA help to drive a steady decrease in our operating cash burn quarter-over-quarter.

I will now turn the presentation back over to Ted. For the next part of the call, Ted will make some closing remarks and then we will head into a Q&A session. Ted.

Theodore Schroeder

Thank you, Dan. Before we move to Q&A, let me summarize our achievements in the quarter and touch a where the Company stands for the remainder of 2021, which can be found on Slide 22.

First, we were thrilled with the performance of SIVEXTRO in the quarter. The first quarter since the onset of the pandemic, where the drug saw 1,000 prescriptions, it is truly a major milestone for the company.

Given the efforts of our field force, as respiratory infections continue to increase in the fourth quarter, we expect to gain market share for XENLETA. During this quarter, we highlighted several new programs and partnerships to enhance all the hard work of our commercial team has done in the field.

We launched the inside sales representatives program. We completed an agreement with Vizient for XENLETA in the hospital, we renegotiated our agreement with Hovione, and we layered on top of that our other achievements, like getting another approval for XENLETA in Taiwan and sharing important first time data on the anti-inflammatory effects of lefamulin.

Over the past year, we have adapted to changing market conditions and we think we are now appropriately positioned to maximize our commercial performance well further broadening our pipeline opportunities. I look forward to updating you on our progress in the coming quarters.

Operator, we are now ready to open up the line for questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Carl Byrnes with Northland Capitals. Your line is now open.

Carl Byrnes

Great, thanks for the question, and congratulations on the progress. Can you break out the SIVEXTRO and lefamulin sales for the third quarter? And then I have a follow-up as well. Thanks.

Dan Dolan

Yes. So, SIVEXTRO sales were roughly I think 7. 9 million in the current quarter, and lefamulin net sales were we took a one-time the specialist returns reserve of a little over a million dollars. So that had us record a negative 900,000 in the quarter for lefamulin.

Carl Byrnes

Thanks. That is helpful. And then also, can you provide an update with respect to the anticipated NDA filing of a lefamulin in China? Thanks

Theodore Schroeder

Yes. Thanks, Carl. Our partner Sumitomo still expects to file that NDA before the end of the year.

Carl Byrnes

Perfect, thanks.

Operator

[Operator Instructions] Our next question comes from the line of Suji Jeong with Jefferies. Your line is now open.

Suji Jeong

Hi, good afternoon. Thanks for taking my question. I have a few questions on XENLETA. Is that the XENLETA going to be available in the hospital formulary network. Is it your plan to reestablish the hospital salesforce with XENLETA, and also, could you comment on how the primary care salesforce is ongoing with XENLETA and SIVEXTRO.

Theodore Schroeder

Sure. Suji. Thanks for the question. We have no current plans to reestablish a hospital's salesforce, at least not a traditional salesforce, as you may be aware because of COVID and lockdown restrictions broadly across hospitals, access in the hospitals for traditional sales reps is very difficult in fact almost non-existent.

So we are leveraging other opportunities to optimize our contract with Vizient, including leveraging Vizient’s insights and analytics to help us present the opportunity for lefamulin in the hospital. So it is not an overnight type of occurrence for the vision system. It will still need to get on formularies, but most of the effort will be driven through our community-based salesforce.

And then the second part of the question regarding, our outpatient focus on XENLETA. So as we mentioned previously, we kept the promotional effort high during the summer months so that XENLETA will be top of mind as we move into the fourth and first quarters of the year, where traditionally we see an increase in respiratory infections.

And as we mentioned last year, the CDC reported that influenza like infections were down 95% in the U.S. We do expect to see a stronger respiratory season this year, as some of the restrictions have come off and children are back to school and people are moving around more freely. And with our salesforce in the position and obviously in XENLETA, we think that we are in a great position to gain market share, as we move into the colder weather months.

In addition to the salesforce, direct sales - we have 60 people promoting the product. And then we just started a pilot program with inside sales reps that are making outbound calls into white space geographies and responding to inbound product inquiries. And then we have a full suite of digital and non-personal efforts to support the treatment decision at the time of prescribing.

Suji Jeong

That is helpful. Thank you.

Theodore Schroeder

You bet Suji. Thank you.

Operator

Our next question is from Ed Arce with H.C. Wainwright. Your line is open.

Unidentified Analyst

Hello everyone. This is [Thomas] (Ph) asking a couple of questions for Eric. Perhaps a question related to XENLETA Phase I study in the cystic fibrosis. As you aligned it in the slide first patient dosing expected in first quarter. So, efficiency safety and PK data, keeping in mind that there is a Phase I study. Can you discuss any of the key end points that we can focus on?

Theodore Schroeder

Thanks for the question. The main end points are safety in PK. It is our first time dosing patients with cystic fibrosis with XENLETA and as you may be aware, sometimes patients with CS have altered pharmacokinetics in handling of drug products.

So, that really is our primary objective. There is not an efficacy readout. It is a single dose study. We are looking at both oral and intravenous form in patients, and hopefully we will get a read on the PK and what those do might make sense and how well it is tolerated.

Unidentified Analyst

Got it. And then perhaps after the Phase I is the plan to develop into Phase II on your own or partner with a non-profit cystic fibrosis foundation?

Theodore Schroeder

No. That is a great question. I think, obviously the data read out from Phase I along with some of the nonclinical work that I alluded to will help to inform the broader development plan. And so, I think it is a little bit premature to speak about what that looks like until we see the data. but we are excited to see what that looks like and see what optionality we have as we move ahead here.

Unidentified Analyst

Understood. Perhaps, one final question for SIVEXTRO and XENLETA. Can you discuss upcoming talents data we can highlight 2022?

Steve Gelone

So, upcoming catalyst will announce the NDA filing in China when Sumitomo files the NDA. Of course, there will be the progress with sales at the quarters. And we are working feverishly on additional out-licensing opportunities for Europe and other rest of world territories.

So we do anticipate in the coming quarters that we will have announcements around those partnerships as well, in addition to the commencing dosing of the Phase 1 cystic fibrosis PK and safety study. I think those are the main catalyst as we look forward to the coming next few quarters.

Unidentified Analyst

Thank you for the taking the questions and we look forward to continue tracking SIVEXTRO traction and your mix update.

Steve Gelone

Alright. Thank you.

Operator

Next question comes from the line of Carl Byrnes with Northland Capital. Your line is now open.

Carl Byrnes

Great. Thanks for a follow-up. Just going back to cash. You references you expect cash balances to be sufficient the front operations into our through rather the second quarter of 2022. Is that inclusive of Lincoln Park agreement that was assumed in 2022 but that is over two years. So how do you look at that?

Dan Dolan

Yes, thanks Carl. So the substantially Q2 of 2022 is just based on operations. It doesn't take into account anything we would do otherwise through the line of credit. We have access to it. It is an efficient way to get to capital if we need it, but we don't factor anything like that into our cash runway.

Carl Byrnes

Great, thanks. And then going back to my prior question with was SIVEXTRO sale was 7.9 is XENLETA one sales, basically being adjusted to negative 900,000. Effectively, the quarter on a normalized basis would have then been more like 10 million plus in terms of revenue, is that correct?

Dan Dolan

I think that is fair. Just to make sure we reported 7.9 total, SIVEXTRO was about 8.9 and then the XENLETA number was about 900,000. So yes, there was about $1 million. It was for the one time reserve we took on the short dated product. We have entered a returns window.

So we took that reserve on XENLETA. If you ship that out, you could say we would have been 900,000 to $1 million higher in the quarter on sales, but SIVEXTRO was 8.9, XENLETA was negative around 900,000 for 7.9 million total in net sales.

Carl Byrnes

Got it. Thanks.

Operator

And there are no further questions. I will now turn the call back over to Mr. Dolan for closing remarks.

Dan Dolan

Thank you everyone. Thanks for joining the call. I appreciate your questions and we look forward to updating you as we continue to make progress. Thanks again, and have a good evening,

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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