Q3 2023 Vanda Pharmaceuticals Inc Earnings Call

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Speaker 1: Ladies and gentlemen, thank you for standing by. My name is Desiree and I will be your conference operator today. At this time, I would like to welcome everyone to the third quarter 2023 Vanda Pharmaceutical Inc. earnings conference call. All lines have been placed on mute to prevent...

Ladies and gentlemen, thank you for standing by my name is graduate and I will be your conference operator today.

This time I would like to welcome everyone to the third quarter 'twenty twenty-three Vanda Pharmaceuticals, Inc earnings Conference call.

All lines have been placed on mute to prevent any background noise.

Speaker 1: After the speaker's remarks, there will be a question and answer session.

After the Speakers' remarks, there will be a question and answer session.

Speaker 1: If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, again, press the star 1. I would now like to turn the conference over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead.

If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad.

If you would like to withdraw your question again press the Star Wise I would know like to turn the conference over to Kevin Moran Vanda Chief Financial Officer. Please go ahead.

Speaker 2: Thank you, Desiree. Good afternoon, and thank you for joining us to discuss VANDA Pharmaceuticals' third quarter 2023 performance.

Thank you good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals third quarter 2023 performance. Our third quarter 2023 results were released this afternoon and are available on the Sec's Edgar system and on our website Www Dot Vanda pharma dotcom and.

Speaker 2: Our third quarter 2023 results were released this afternoon and are available on the SEC's EDCRA system and on our website www.vandafarma.com

Speaker 2: In addition, we are providing live and archived versions of this conference call on our website.

In addition were providing live and archived versions of this conference call on our website.

Speaker 2: Joining me on today's call is Dr. Mahalis Pali-Moropoulos, our President, Chief Executive Officer and Chairman of the Board, and Tim Williams, our General Counsel.

Joining me on today's call is Dr. <unk>, Polymeropoulos, our president and Chief Executive Officer, and Chairman of the Board and Tim Williams, Our General Counsel.

Speaker 2: Following my introductory remarks, Mahalis will update you on ongoing activities. I will then comment on our financial results before opening the lines for your questions.

Following my introductory remarks from house will update you on ongoing activities I will then comment on our financial results before opening the lines for your questions.

Speaker 2: Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainty.

Before we proceed I would like to remind everyone that various statements that we make on this call will be forward looking statements within the meaning of federal securities laws.

Our forward looking statements are based upon current expectations and assumptions that involve risks changes in circumstances and uncertainties.

Speaker 2: These risks are described in the cautionary note regarding forward-looking statements, risk factors, and management's discussion and analysis of financial condition and results of operations, sections of our most recent annual report on Form 10-K , as updated by our subsequent quarterly reports on Form 10-Q , current reports on Form 8-K, and other filings with the SEC, which are available on the SEC's EDGAR system and on our website.

These risks are described in the cautionary note regarding forward looking statements risk factors and management's discussion and analysis of financial condition and results of operations sections of our most recent annual report on Form 10-K.

As updated by our subsequent quarterly reports on Form 10-Q current reports on form 8-K, and other filings with the SEC, which are available on the Sec's Edgar system and on our web site we.

Speaker 2: We encourage all investors to read these reports and our other filings.

We encourage all investors to read these reports and our other filings.

The information we provide on this call is provided only as of today and we undertake no obligation to update or revise publicly any forward looking statements. We may make on this call on account of new information future events or otherwise, except as required by law.

Speaker 2: The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events, or otherwise, except as required by law. With that said, I would now like to turn the call over to our CEO , Dr. Mahalis Pali-Mirapol.

With that said I would now like to turn the call over to our CEO Dr. Mark <unk>. Thank.

Speaker 3: Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us.

Thank you very much Kevin and good afternoon, everyone. Thank you for joining us.

Speaker 3: to discuss BANDAS third quarter, 2023 results.

To discuss <unk> third quarter 2022 cells.

Speaker 3: I will briefly discuss key updates and then I will ask our General Counsel Tim Williams.

I will briefly discuss key updates and then I will ask our general counsel, Tim Williams to provide a brief update on litigation matters before I turn the call over to Kevin to discuss our overall progress and financial results.

Speaker 3: to provide a brief update on litigation matters before turn the call over to Kevin to discuss our overall progress and financial results. We have significantly advanced our development pipeline, now expecting FDA decisions on two supplemental NDAs for bipolar one disorder in adults and insomnia with Piduva dates in the first half of 2024.

We have significantly advanced our development pipeline now expect an FDA decision on two supplemental NDA for bipolar one disorder.

Dallas and in some yeah.

Can do five days in the first half of 2024.

Additionally, we expect a regulatory decision on our NDA for the dividend in patients with Gastroparesis by approximately mid 2024.

Speaker 3: Additionally, we expect a regulatory decision on our NDA for the redipitent in patients with gastroparesis by approximately mid-2024.

Speaker 3: We're also pleased with our revenue performance despite the challenges of the at-risk launch of the generic catlios product.

We're also pleased with our revenue performance. Despite the challenges of the at risk launch of Internet it carefully as product.

Speaker 3: Over the course of this year, we have taken a number of actions to position the commercial business for continued success, both on existing products and indications, as well as potential future products and indicators.

Over the course of this year, we have taken a number of actions to position the commercial business for continued success, both on existing products and indications as well as potential future products and indications.

Speaker 3: This includes preparations for the potential near-term expansion of the FANAP franchise if we receive FDA approval for Bipolar I disorder in adults.

This includes preparations for the potential expansion of the Fanapt franchise, if we receive FDA approval for bipolar one disorder than adults.

Speaker 3: Finally, we look forward to increasing and diversifying our future revenue sources, both with these new products and new indications on existing products and also potentially with external business development activities.

Finally, we look forward to increasing and diversifying our future revenue sources, both with these new projects and new indications on existing products and also potentially with external business development activities.

With that I will now ask Kevin Williams General counsel to provide a brief update on litigation matters.

Speaker 4: With that, I will now ask Tim Williams, the General Counsel, to provide a brief update on litigation matters. Tim. Thank you, Mahalas. I'll start with our Hetlios and the litigation. As previously disclosed, we intend to file a cert petition with the U.S. Supreme Court to review the federal circuits ruling in our Hetlios and the litigation.

Thank you Paula.

I'll start with our <unk> Ando litigation.

As previously disclosed we intend to file a petition with the U S. Supreme Court to review the federal Circuit's ruling in our <unk> litigation.

Speaker 4: We believe the Federal Circuit applied a flawed obviousness standard to our Hetlio's patents that is inconsistent with Supreme Court press.

We believe the federal circuit applied a flawed obviousness standard to our <unk> patents that is inconsistent with the Supreme Court Preston.

Specifically, we believe the federal circuit's approach to obvious deviated materially from the Supreme Court standard articulated in the Ks RV Teleflex case from 2007.

Speaker 4: Specifically, we believe the federal circuits approach to obviousness deviated materially from the Supreme Court standard articulated in the KSRV teleplex case from 2007.

Speaker 4: We believe the Federal Circuit's approach improperly invalidated our patent rights. And if unchallenged, this approach could continue to harm pharmaceutical innovation.

We believe the federal circuit's approach improperly and validated our patent rights and if I'm challenge. This approach could continue to harm pharmaceutical innovation.

Speaker 4: We recently filed for an extension of time for our cert petition. The extension was granted by Chief Justice Roberts, and we expect to file our cert petition by January 12, 2024.

We recently filed for an extension of time for a certification. The extension was granted by Chief Justice Roberts and we expect to file our certification by January 12 2024.

Separately in September we filed suit against the FDA challenging its approval of NSM laboratories generic version of Tazemetostat.

Speaker 4: Separately, in September , we filed suit against the FDA, challenging its approval of NSN Laboratories' generic version of Tasmil.

Speaker 4: We believe the bioequivalent studies underlying MSN's approval are faulty, and the FDA's approval should be revoked. In this case, it's currently pending in the...

We believe the bioequivalence studies underlying NSF approval or faulty and the fda's approval should be revoked.

Cases currently pending in the D C District Court.

Speaker 4: And we continue to pursue our other litigation related to our HETLEO's patents and generic competition, all of which has been previously disclosed. I'll shift now.

And we continue to pursue our other litigation related to our <unk> patents and generic competition all of which has been previously disclosed.

I'll shift now to our other regulatory litigation efforts.

Speaker 4: Since May of this year, we have filed six additional FOIA lawsuits against the FDA as part of our ongoing effort to hold regulators accountable to the law.

Since may of this year, we have filed six additional voya lawsuits against the FDA as part of our ongoing effort to hold regulators accountable to the law.

Speaker 4: We intend to continue seeking transparency from our regulators, especially the FDA.

We intend to continue seeking transparency from our regulators, especially the F D a D.

Speaker 4: Details of all of our regulatory cases can be found in our disclosures and in publicly available court records.

Details of all of our regulatory cases can be found in our disclosures and then publicly available Court records.

And last we continue to pursue our challenge against CMS as line extension rule at the fourth Circuit Court of Appeals.

Speaker 4: And last, we continue to pursue our challenge against CMS's line extension rule at the Ford Circuit Court of Appeals.

Speaker 4: Just last week, the fourth circuit's tentatively scheduled an oral argument to hear our appeal in January 2024.

Just last week, the fourth circuit to tentatively scheduled an oral argument to hear our appeal in January 2024.

Back to your house.

Speaker 3: Thank you, Tim. I'll turn now to our Kevin Moran to discuss our overall progress and financial results for this quarter, Kevin.

Thank you Tim I'll turn now to Kevin Brian to discuss our overall progress and financial results for this quarter Kevin.

Thank you miles.

Speaker 2: I'll first discuss key regulatory and clinical updates before providing an update on our commercial progress and financial results.

I'll first discuss key regulatory and clinical updates before providing an update on our commercial progress and financial results.

Speaker 2: Beginning with our upcoming regulatory milestones. We are now expecting FDA decisions on two supplemental new drug application filings in the first half of 2024.

Beginning with our upcoming regulatory milestones, we are now expecting FDA decisions on two supplemental new drug application filings in the first half of 2024.

Speaker 2: First, I'm Phenat for Bipolar 1 Disorder. As previously discussed, in December of last year, we announced positive results in our phase three clinical study of Phenat in acute manic and mixed-death sores with bipolar 1 disorder in adults.

First on Fanapt for bipolar one disorder as previously discussed in December of last year, We announced positive results in our phase III clinical study of Fanapt in acute <unk> and mixed episodes with bipolar one disorder in adults or.

Speaker 2: Our supplemental new drug application for FNAFT and bipolar 1 disorder in adults has now been accepted by the FDA and the target action date has been set as April 2nd, 2024.

Our supplemental new drug application for Fanapt in bipolar one disorder in adults has now been accepted by the FDA and the target action date has been set as April 2024.

Speaker 2: We believe that this potential label expansion represents a significant opportunity for the FNAB franchise given the high prevalence of bipolar disorder in the United States.

We believe that this potential label expansion represents a significant opportunity for the <unk> franchise, given the high prevalence of bipolar disorder in the United States.

Speaker 2: The estimated prevalence of bipolar disorder in the US adult population is approximately 3%. A number approximately up to 10 times higher than the estimated prevalence of schizophrenia.

The estimated prevalence of bipolar disorder in the U S. Adult population is approximately 3% a number approximately up to 10 times higher than the estimated prevalence of schizophrenia.

On <unk> for insomnia, our supplemental new drug application for <unk> and Insomnia also has now been accepted by the FDA and the target action date has been set as March 4th 2024.

Speaker 2: on Hetlios for Insomnia. Our supplemental new drug application for Hetlios in Insomnia also has now been accepted by the FDA and the target action date has been set as March 4th, 2024.

Speaker 2: We believe that Hetley-Ousfer Insomnia could represent a meaningful commercial opportunity and provide an exciting therapy to go up for a patient.

We believe that it was for insomnia could represent a meaningful commercial opportunity and provide an exciting therapeutic option for patients.

Additionally, on <unk> for patients with Gastroparesis, we expect a regulatory decision on this new drug application by approximately mid 2024. The FDA package is supported by the results of our three clinical studies that we believe demonstrate substantial evidence of efficacy of <unk> in this indication as well as the safety database.

Speaker 2: Additionally, on Tredipinant for patients with gastrophoresis, we expect a regulatory decision on this new drug application by approximately mid-2024. The FDA package is supported by the results of our three clinical studies that we believe demonstrate substantial evidence of efficacy of Tredipinant in this indication, as well as a safety database to support the tolerability of the stroke.

To support the Tolerability of this drug.

Speaker 2: The expanded access program continues with multiple patients having been treated for at least six months and the longest treated patient for more than two years.

The expanded access program continues with multiple patients having been treated for at least six months and the longest treated patients for more than two years.

On the clinical side, continuing with traditional as previously reported in May of this year, we announced positive results from the first phase III study of <unk> in the treatment of motion sickness.

Speaker 2: on the clinical side, continuing with tridipinant, as previously reported in May of this year, we announced positive results from the first phase three study of tridipinant in the treatment of motion six.

Speaker 2: We now have initiated a second phase three study of tritipidant emotion sickness, and the study is already over 20% enrolled.

We now have initiated a second phase III study of two dividend and motion sickness and the study is already over 20% enrolled.

Speaker 2: We plan to pursue FDA approval of Tridipinant Promotion Cygnus upon completion of the Clinical Development Program.

We plan to pursue FDA approval of <unk> for motion sickness upon completion of the clinical development program.

Speaker 2: And outside of this update on the Trident-Motion Stickness program, we continue to progress a robust clinical development pipeline, which includes multiple products across a wide range of therapeutic areas.

And outside of this update on the Triptan that motion sickness program, we continue to progress our robust clinical development pipeline, which includes multiple products across a wide range of therapeutic areas.

Turning to our commercial progress and financial results.

Speaker 2: Taking into account the challenging environment due to the at-risk launch of generic Tazameltian, we are pleased with our commercial performance during the first nine months of the year. On Hetlius, despite these challenges, our team delivered solid performance and continues to work tirelessly to support patients on therapy and prescribed.

Into account the challenging environment due to the at risk launch of generic CASM LTE and we are pleased with our commercial performance during the first nine months of the year.

Despite these challenges our team delivered solid performance and continues to work tirelessly to support patients on therapy and prescribers.

On Fanapt, we remain focused on driving growth in the currently approved indication of schizophrenia, and ensuring fanapt is well positioned to capitalize on the bipolar market if approved.

Speaker 2: On FNAFT, we re-infocussed on driving growth in the currently approved indication of schizophrenia, and ensuring FNAFT is well positioned to capitalize on the bifallure market if approved.

Speaker 2: On our financial results, I will begin by summarizing the first nine months of 2023 before turning to discuss the third quarter of 2020.

On our financial results I'll begin by summarizing the first nine months of 2023 before turning to discuss the third quarter of 2023.

Speaker 2: Total revenues for the first nine months of 2023 were 147.4 million, a 22% decrease compared to 189.9 million for the same period in 2022.

Total revenues for the first nine months of 2023 were $147 4 million or 22% decrease compared to a $189 9 million for the same period in 2022.

Speaker 2: Hetley O-Snet products sales were 79.1 million for the first nine months of 2023, and saw a 34% decrease compared to 119.6 million for the same period in 2022.

<unk> net product sales were $79 1 million for the first nine months of 2023 and saw a 34% decrease compared to $119 6 million for the same period in 2022.

Speaker 2: The at-risk launch of a generic version of Hetlios had a significant impact on Hetlios performance during the first nine months of 2023.

The at risk launch of a generic version of <unk> had a significant impact on <unk> performance. During the first nine months of 2023.

Speaker 2: The decreased net product sales was attributable to a decrease in price net of deductions, partially offset by an increase in volume.

The decrease to net product sales was attributable to a decrease in price net of deductions, partially offset by an increase in volume.

Speaker 2: Our HETLEO SNET product sales for the first quarter of 2023 reflected higher unit sales as compared to recent prior periods and as resulted in a significant increase of inventory stocking at specialty pharmacy customers throughout 2023.

Our heaviest net product sales for the first quarter of 2023 reflected higher unit sales as compared to recent prior periods and has resulted in a significant increase of inventory stocking of specialty pharmacy customers throughout 2023.

Turning to Fanapt.

Speaker 2: Fanatnet products sales of 68.3 million for the first nine months of 2023 reflect a 3% decrease compared to 70.3 million for the same period in 2022

<unk> net product sales of $68 3 million for the first nine months of 2023 reflect a 3% decrease compared to $70 3 million for the same period in 2022.

Speaker 2: For the first nine months of 2023, Vander reported net income of 4.9 million compared to a net loss of 0.6 million for the same period in 2022.

For the first nine months of 2023 banner reported net income of $4 9 million compared to a net loss of <unk> 6 million for the same period in 2022.

Speaker 2: Net income for the first nine months of 2023, including income tax provision of 3.1 million, as compared to an income tax provision of 2.3 million for the same period in 2022.

Net income for the first nine months of 2023 included an income tax provision of $3 1 million as compared to an income tax provision of $2 3 million for the same period in 2022.

Operating expenses for the first nine months of 2023 were $154 2 million compared to $190 2 million for the same period in 2022.

Speaker 2: Operating expenses for the first nine months of 2023 were 154.2 million compared to 190.2 million for the same period in 2022.

Speaker 2: The 36 million decrease was primarily driven by lower R&D expenses, lower SG&A expenses, and lower cost of goods sold. The decrease in R&D expenses was primarily driven by decreases related to our late-stage clinical program for FNAFT and our VQW765 development program, partially offset by increases related to our tri-dipinant activities and our early-stage ASO program.

The $36 million decrease was primarily driven by lower R&D expenses, lower SG&A expenses and lower cost of goods sold.

The decrease in R&D expenses was primarily driven by decreases related to our late stage clinical program for Fanapt and our <unk> 765 development program, partially offset by increases related to our traditional activities and our early stage ASO program.

The decrease in SG&A expenses was primarily driven by lower expenses associated with marketing sales and commercial support activities for our commercial products.

Speaker 2: The decrease in estrogen A expenses was primarily driven by lower expenses associated with marketing, sales, and commercial support activities for a commercial product.

Speaker 2: The lower cost of goods sold is due to lower Hetleos net product sales and the decrease in the royalty rate owed to BMS on Hetleos net product sales from 10% to 5% effective in December 2022.

The lower cost of goods sold is due to lower <unk> net product sales and the decrease in the royalty rate owed to BMS on <unk> net product sales from 10% to 5% effective in December 2022.

BNS cash cash equivalents in marketable securities referred to as cash as of September 32023 was $489 9 million, representing an increase of $35 1 million to cash compared to September 32022, and an increase of <unk> <unk>.

Speaker 2: Vanis Cash, Cash equivalent to marketable securities, referred to as Cash, as of September 30th, 2023, was 489.9 million, representing an increase of 35.1 million to cash, compared to September 30th, 2022, and an increase of 23 million compared to December 31st of 2022.

$23 million compared to December 31, 2022.

Turning now to our quarterly results.

Speaker 2: Total revenues for the third quarter of 2023 were $38.8 million, a 41% decrease compared to $65.3 million for the third quarter of 2022. Hetlio's net product sales were $17.5 million for the third quarter of 2023, a 58% decrease compared to $41.3 million in the third quarter of 2022.

Total revenues for the third quarter of 2023 were $38 8 million or 41% decrease compared to $65 3 million for the third quarter of 2022.

<unk> net product sales were $17 5 million for the third quarter of 2023% to 58% decrease compared to $41 3 million in the third quarter of 2022.

Speaker 2: The at-risk launch of a generic version of HETLEO's continued to have a significant impact on HETLEO's performance during the third quarter of 2023.

At risk launch of a generic version of heavier <unk> continued to have a significant impact on <unk> performance during the third quarter of 2023.

Speaker 2: The decrease in net product sales was attributable to a decrease in volume.

The decrease in net product sales was attributable to a decrease in volume.

Speaker 2: Our Hetley O's net product sales, as reported for the first quarter of 2023, reflected higher unit sales as compared to recent periods. The higher unit sales during the first quarter of 2023 resulted in a significant increase of inventory stocking as specialty farms fee customers throughout 2020.

Our <unk> net product sales as reported for the first quarter of 2023 reflected higher unit sales as compared to recent periods. The higher unit sales during the first quarter of 2023 resulted in a significant increase of inventory stocking is specialty pharmacy customers throughout 2023.

Speaker 2: Hethiose Net Product Sale during the third quarter of 2023 reflect lower unit sales, which was partially attributable to the continued reduction of the elevated inventory levels at specialty pharmacy customers at the end of the first quarter of 2023.

<unk> net product sales during the third quarter of 2023 reflect lower unit sales, which was partially attributable to the continued reduction of the elevated inventory levels at specialty pharmacy customers at the end of the first quarter of 2023.

Turning now to Fanapt.

Speaker 2: FNAF Net Product Sales were 21.3 million for the third quarter of 2023, an 11% decrease compared to 24 million in the third quarter of 2022.

<unk> net product sales were $21 3 million for the third quarter of 2023, and 11% decrease compared to $24 million in the third quarter of 2022.

Speaker 2: FNAF product sales in the third quarter of 2023 decreased by 11% as compared to 24.1 million in the second quarter of 2023.

Net product sales in the third quarter of 2023 decreased by 11% as compared to $24 1 million in the second quarter of 2023.

Speaker 2: This decrease between the second and third quarters of 2023 was primarily attributable to destocking a finapped inventory at the wholesaler level and unfavorable gross to net adjustments during the period.

This decrease between the second and third quarters of 2023 was primarily attributable to Destocking of Fanapt inventory at the wholesaler level and unfavorable gross to net adjustments during the period.

Speaker 2: FNAF prescriptions in the third quarter of 2023, as reported by Equivia Exponent, decreased by approximately 4% compared to the second quarter of 2023.

Fanapt prescriptions in the third quarter of 2023 as reported by <unk> decreased by approximately 4% compared to the second quarter of 2023.

Okay.

Speaker 2: For the third quarter of 2023, Vander recorded net income of .1 million compared to net income of 3.3 million for the third quarter of 2022.

For the third quarter of 2023, Vanda recorded net income of <unk> 1 million compared to net income of $3 3 million for the third quarter of 2022 net.

Speaker 2: that income for the third quarter of 2023 included an income tax benefit of 0.3 million as compared to an income tax provision of 2.2 million for the same period in 2022.

Net income for the third quarter of 2023 included an income tax benefit of <unk> 3 million as compared to an income tax provision of $2 2 million for the same period in 2022.

Operating expenses in the third quarter of 2023 were $44 8 million compared to $61 4 million in the third quarter of 2022 to $16 6 million decrease was primarily driven by lower R&D expenses related to our late stage snap development program and our early stage ASO program lower ASP.

Speaker 2: Operating expenses in the third quarter of 2023 were 44.8 million compared to 61.4 million in the third quarter of 2022.

Speaker 2: The 16.6 million decrease was primarily driven by lower R&D expenses related to our late stage FNAF development program and our early stage ASO program. Lower SUNA expenses related to spending on marketing and sales activities for our commercial products.

G&A expenses related to spending on marketing and sales activities for our commercial products and lower cost of goods sold due to lower <unk> net product sales and the decrease in the royalty rate owed to BMS on <unk> net product sales from 10% to 5% effective in December 2022.

Speaker 2: and lower cost of goods sold due to lower Hetlios Net Product sales and the decrease in the royalty rate owed to BMS on Hetlios Net Product sales from 10% to 5% effective in December 2022.

Speaker 2: Operating expenses in the third quarter of 2023 decreased by 4.1 million as compared to 48.9 million in the second quarter of 2020.

Operating expenses in the third quarter of 2023 decreased by $4 1 million as compared to $48 9 million in the second quarter of 2023.

Speaker 2: This decrease was primarily driven by lower S-GN expenses related to spending on fails activities for a commercial product.

This decrease was primarily driven by lower SG&A expenses related to spending on sales activities for our commercial products.

Given uncertainties surrounding the U S market for <unk> for the treatment of non 24 as a result of the ongoing patent litigation and the at risk launch of a generic version of <unk> Vanda is unable to provide 2023 financial guidance at this time.

Speaker 2: Given uncertainties surrounding the US market for HEPLIOUS for the treatment of non-24, as a result of the ongoing HEPLIOUS patent litigation and the at-risk launch of a generic version of HEPLIOUS, Vanda is unable to provide 2023 financial guidance at this time.

Speaker 2: Vanna will continue to evaluate its abilities to provide financial guidance in future periods.

Vanda will continue to evaluate its ability to provide financial guidance in future periods.

Speaker 2: Hatleos net product sales will likely decline in future periods, potentially significantly related to the at-risk launch of a generic version of Hatleos in the US.

<unk> net product sales will likely decline in future periods potentially significantly related to the at risk launch of a generic version of <unk> in the U S.

Speaker 2: Additionally, the company constrained Hethiose Net Product Sales for the first nine months of 2023 to an amount not probable of significant revenue reversal. As a result, Hethiose Net Product Sales could experience variability in future periods as the remaining uncertainties associated with variable consideration are resolved. With that, I'll now turn the call back to Mahalas. Thank you very much, Kevin. At this point,

Additionally, the company constrained heaviest net product sales for the first nine months of 2023 to an amount not probable of significant revenue reversal as a result, <unk> net product sales could experience variability in future periods as the remaining uncertainties associated with variable consideration are resolved.

With that I'll now turn the call back to the house.

Hey, Matt it's Kevin at this point.

We will be happy to answer your questions.

Okay.

The floor is now open for your questions to ask a question this time.

Speaker 1: The floor is now open for your questions. To ask a question this time, please press star then the number one on your telephone keypad. We'll pause for just a moment.

Press Star then the number one on your telephone keypad.

Pause for just a moment to compile the Q&A roster.

Okay.

There are no further questions at this time I would like to turn the call back over to Vanda management for closing remarks.

Speaker 1: There are no further questions at this time. I would like to turn the call back over to Vanda Management for closing remarks.

Thank you all for joining us this.

Speaker 3: Thank you all for joining us this 3rd quarter of 2020, 3rd Call, and we'll see you in the future.

Third quarter 2023 call.

We'll see you in the future periods.

Thank you.

Speaker 1: This concludes today's conference call. You may now...

This concludes today's conference call you may now disconnect.

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