Last update 21 Nov 2024
Levoketoconazole
Last update 21 Nov 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms (2S,4R)-ketoconazole, 2S-4R-ketoconazole, LDKTZ + [7] |
Mechanism CYP11B1 inhibitors(Steroid 11-beta-hydroxylase inhibitors), CYP17A1 inhibitors(Steroid 17-alpha-hydroxylase inhibitors), CYP21A2 inhibitors(Steroid 21 hydroxylase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (30 Dec 2021), |
RegulationOrphan Drug (EU) |
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Structure
Molecular FormulaC26H28Cl2N4O4 |
InChIKeyXMAYWYJOQHXEEK-ZEQKJWHPSA-N |
CAS Registry142128-57-2 |
Related
9
Clinical Trials associated with LevoketoconazoleA Phase 1 Randomized, Open-Label, Two-Period,Two-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Levoketoconazole and Ketoconazole Tablets in Healthy Subjects
This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the relative oral bioavailability of levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug product).
Start Date16 Dec 2019 |
Sponsor / Collaborator |
A Phase I Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Levoketoconazole on the Single-Dose Pharmacokinetics of Metformin in Healthy Subjects
This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.
Start Date28 Mar 2019 |
Sponsor / Collaborator |
An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome
This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.
Start Date07 Jan 2019 |
Sponsor / Collaborator |
100 Clinical Results associated with Levoketoconazole
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100 Translational Medicine associated with Levoketoconazole
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100 Patents (Medical) associated with Levoketoconazole
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78
Literatures (Medical) associated with Levoketoconazole01 Jul 2024·Indian Journal of Endocrinology and Metabolism
Efficacy and Safety of Levoketoconazole in Managing Cushing’s Syndrome: A Systematic Review
Review
Author: Dutta, Deep ; Raizada, Nishant ; Patra, Shinjan ; Nagendra, Lakshmi
30 May 2023·Foods (Basel, Switzerland)
Degradation Dynamics and Residue Analysis of Four Propiconazole Stereoisomers in "Fengtang" Plum during Storage by LC-MS/MS.
Article
Author: Mou, Lianhong ; Deng, Pengyu ; Luo, Xin ; Ou, Guipeng ; Zhang, Yuping ; Hu, Deyu
01 Dec 2022·Pituitary
Levoketoconazole in the treatment of patients with endogenous Cushing’s syndrome: a double-blind, placebo-controlled, randomized withdrawal study (LOGICS)
Article
Author: Brue, Thierry ; Elenkova, Atanaska ; Stigliano, Antonio ; Pivonello, Rosario ; Shimon, Ilan ; Badiu, Corin ; Fleseriu, Maria ; Zacharieva, Sabina ; Tóth, Miklós ; Tsagarakis, Stylianos ; Cohen, Fredric ; Georgescu, Carmen Emanuela
58
News (Medical) associated with Levoketoconazole08 Nov 2024
CHICAGO--(
BUSINESS WIRE
)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the third quarter and nine months ended September 30, 2024.
“We are proud to report our record-breaking quarter with total revenue of our $54 million led by strong demand of Recorlev® and Gvoke®. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth," said John Shannon, CEO of Xeris. "We have made investments in areas that drive growth, notably Recorlev®, and we are seeing the benefits of those investments. Given our exceptional year-to-date performance, we are raising our revenue guidance to $198-$202 million from the previous $190-$200 million. Looking ahead, our focus remains on continuing to drive greater than 20% product revenue growth and advancing our robust pipeline - namely our Phase 3 ready, XP-8121."
“While delivering exceptional revenue growth, we held our total operating expenses relatively flat to last quarter when you exclude non-routine charges,” said Steven Pieper, CFO of Xeris. “We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.”
Third Quarter 2024 Highlights
Three Months Ended
September 30,
Change
2024
2023
$
%
Product revenue (in thousands):
Gvoke
$
22,942
$
17,735
$
5,207
29.4
Recorlev
17,726
8,097
9,629
118.9
Keveyis
12,193
15,865
(3,672
)
(23.1
)
Product revenue, net
52,861
41,697
11,164
26.8
Royalty, contract and other revenue
1,407
6,623
(5,216
)
(78.8
)
Total revenue
$
54,268
$
48,320
$
5,948
12.3
Commercial Products
Gvoke®
: Third quarter net revenue was $22.9 million as compared to $17.7 million in the third quarter of 2023 – an increase of approximately 29%. Gvoke prescriptions topped 70,000 for the first time, growing 20% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 36% at the end of October.
Recorlev®
: Third quarter net revenue was $17.7 million – an increase of 119% compared to the third quarter of 2023. This growth was driven by the average number of patients on Recorlev increasing 125% from the same period in 2023. On a sequential basis, Recorlev net revenue increased 33% versus prior quarter.
Keveyis®
: Third quarter net revenue was $12.2 million as compared to $15.9 million in the third quarter of 2023 - a decrease of approximately 23% driven by a reduction in patients on therapy. On a sequential basis, net revenue decreased 7% due to pharmacy reimbursement changes.
Year-to-Date 2024 Financial Results
Nine Months Ended
September 30,
Change
2024
2023
$
%
Product revenue (in thousands):
Gvoke
$
59,567
$
48,406
$
11,161
23.1
Recorlev
41,663
19,741
21,922
111.0
Keveyis
38,406
42,708
(4,302
)
(10.1
)
Product revenue, net
139,636
110,855
28,781
26.0
Royalty, contract and other revenue
3,335
8,669
(5,334
)
(61.5
)
Total revenue
$
142,971
$
119,524
$
23,447
19.6
Gvoke®
: Net revenue was $59.6 million for the nine months ended September 30, 2024, a 23% increase compared to prior year. Gvoke prescriptions for the nine months were approximately 194,000, growing approximately 24% compared to the same period in 2023.
Recorlev®
: Net revenue was $41.7 million for the nine months ended September 30, 2024, a 111% increase from last year, driven by an increase in the number of patients on therapy.
Keveyis®
: Net revenue was $38.4 million for the nine months ended September 30, 2024, a 10% decrease from last year due to a reduction in patients on therapy.
Cost of goods sold
increased $5.4 million and $6.3 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. These increases were primarily due to a $3.6 million write-off of Gvoke components resulting from manufacturing process changes required to support ongoing Gvoke capacity expansion efforts.
Research and development (R&D) expenses
increased slightly by $0.9 million and $3.5 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. R&D increased primarily due to higher spending for pipeline and personnel related expenses.
Selling, general and administrative (SG&A) expenses
increased by $7.7 million and $14.8 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023, primarily due to the costs associated with the CEO succession plan and related restructuring ($6.1 million) as well as higher costs related to the Recorlev expansions, partially offset by lower external spending.
Net Loss
for the three months ended September 30, 2024, was $15.7 million, or ($0.11) per share, and $49.7 million, or ($0.34) per share, for the nine months ended September 30, 2024. Excluding the impact of the CEO succession plan and related restructuring costs of $6.1 million, earnings per share was ($0.06) for the quarter or ($0.30) for the year-to-date.
Cash, cash equivalents, and short-term investments
at September 30, 2024 was $69.4 million, compared to $72.5 million at December 31, 2023. Total shares outstanding at October 31, 2024 was 149,081,461.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results.
To pre-register for the call, please go to the following link:
https://www.netroadshow.com/events/login?show=6c5018a9&confId=72180
After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Friday, November 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 906920
To join the webcast, please visit “Events” on investor relations page of the Company’s website at
www.xerispharma.com
or use this link:
https://events.q4inc.com/attendee/232807470
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, a proven therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol® and XeriJect®, supporting long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit
www.xerispharma.com
, or follow us on
X,
LinkedIn
, or
Instagram
.
Forward-Looking Statements
Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline (including XP-8121), and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Product revenue, net
$
52,861
$
41,697
$
139,636
$
110,855
Royalty, contract and other revenue
1,407
6,623
3,335
8,669
Total revenue
54,268
48,320
142,971
119,524
Costs and expenses:
Cost of goods sold
13,593
8,201
27,354
21,075
Research and development
5,888
5,034
19,468
15,959
Selling, general and administrative
44,969
37,287
123,342
108,527
Amortization of intangible assets
2,711
2,711
8,132
8,132
Total costs and expenses
67,161
53,233
178,296
153,693
Loss from operations
(12,893
)
(4,913
)
(35,325
)
(34,169
)
Other expense
(6,169
)
(7,614
)
(16,666
)
(15,709
)
Net loss before benefit from income taxes
(19,062
)
(12,527
)
(51,991
)
(49,878
)
Income tax benefit
3,324
338
2,268
1,013
Net loss
$
(15,738
)
$
(12,189
)
$
(49,723
)
$
(48,865
)
Net loss per common share - basic and diluted
$
(0.11
)
$
(0.09
)
$
(0.34
)
$
(0.36
)
Weighted average common shares outstanding - basic and diluted
148,993,823
138,059,781
145,962,198
137,523,202
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
September 30, 2024
December 31, 2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
59,232
$
67,449
Short-term investments
10,170
5,002
Trade accounts receivable, net
41,138
39,197
Inventory
45,119
38,838
Prepaid expenses and other current assets
7,140
5,778
Total current assets
162,799
156,264
Property and equipment, net
5,613
5,971
Intangible assets, net
101,632
109,764
Goodwill
22,859
22,859
Operating lease right-of-use assets
22,758
23,204
Other assets
5,443
4,540
Total assets
$
321,104
$
322,602
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
7,451
$
11,565
Current portion of long-term debt
15,057
—
Current operating lease liabilities
6,042
3,495
Other accrued liabilities
23,543
23,510
Accrued trade discounts and rebates
20,519
22,149
Accrued returns reserve
17,723
14,198
Current portion of contingent value rights
—
19,109
Other current liabilities
678
1,167
Total current liabilities
91,013
95,193
Long-term debt, net of unamortized debt issuance costs
216,227
190,932
Non-current contingent value rights
—
1,379
Non-current operating lease liabilities
33,639
34,764
Deferred tax liabilities
—
2,268
Other liabilities
8,548
4,848
Total liabilities
349,427
329,384
Total stockholders’ equity (deficit)
(28,323
)
(6,782
)
Total liabilities and stockholders’ equity (deficit)
$
321,104
$
322,602
Financial Statement
22 Aug 2024
CHICAGO--(
BUSINESS WIRE
)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that members of its senior management will take part in the following events:
2024 Wells Fargo Healthcare Conference, Boston, MA
Meetings only on September 4, 2024
H.C. Wainwright 26
th
Annual Global Investor Conference, New York, NY
Meetings and fireside chat on September 10, 2024 at 3:30pm ET
2024 Cantor Global Healthcare Conference, New York, NY
Meetings only on September 18, 2024
Please check with each conference sponsor to arrange 1x1 meetings.
Webcast information for the fireside chat will be available at
https://xerispharma.com/investor-relations
.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect®, to support long-term product development and commercial success.
Xeris is headquartered in Chicago, IL. For more information, visit
www.xerispharma.com
, or follow Xeris on
Twitter
,
LinkedIn
or
Instagram
.
08 Aug 2024
CHICAGO--(
BUSINESS WIRE
)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2024 and recent corporate events.
“I am very pleased to report that we posted an outstanding quarter of $48 million in total revenue, which included record product revenue of over $46 million driven by strong demand for all three of our products. Our year-over-year product revenue growth of 26% represents the eleventh consecutive quarter of over 20% growth as our diverse product portfolio of Recorlev
®
, Gvoke
®
, and Keveyis
®
all continue to meet important unmet needs for patients,” said John Shannon, CEO of Xeris Biopharma. “Our strong performance leads us to now envision full year results at the high end of our original range, and we’re tightening our guidance to $190-$200 million from the previous $175-$200 million. We also believe that this performance will enable us to perform at the higher end of our year-end cash range, so we’re tightening that guidance to $60-$75 million.” Mr. Shannon continued, “This is an exciting time for Xeris, and I’m thrilled to be leading as CEO for the next phase of our journey building upon the strong foundation we’ve created to drive our revenues and pipeline to new heights.”
Second Quarter 2024 Highlights
Three Months Ended June 30,
Change
2024
2023
$
%
Product revenue (in thousands):
Gvoke
$
20,046
$
15,638
$
4,408
28.2
Keveyis
13,128
14,088
(960
)
(6.8
)
Recorlev
13,338
7,167
6,171
86.1
Product revenue, net
46,512
36,893
9,619
26.1
Royalty, contract and other revenue
1,553
1,115
438
39.3
Total revenue
$
48,065
$
38,008
$
10,057
26.5
Commercial Products
Gvoke
®
: Second quarter net revenue was $20.0 million as compared to $15.6 million in the second quarter of 2023 – an increase of approximately 28%. Gvoke prescriptions topped 65,000 for the first time, growing 27% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 34% at the end of July.
Keveyis
®
: Second quarter net revenue was $13.1 million as compared to $14.1 million in the second quarter of 2023 - a decrease of approximately 7% due to generic competition. Net revenue was unchanged from the first quarter of 2024.
Recorlev
®
: Second quarter net revenue was $13.3 million – an increase of 86% compared to the second quarter of 2023. The average number of patients on Recorlev increased 124% from the same period in 2023
.
Technologies Programs
XeriSol™ levothyroxine (XP-8121)
: In May, Xeris announced positive topline results from its Phase 2 multi-center, open label, study of XP-8121 for the treatment of adults with hypothyroidism. The Company anticipates an end-of-Phase 2 meeting with the FDA before year-end.
XeriSol™ glucagon for pumps:
In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics, Inc. for the development and commercialization of a unique glucagon product for use in Beta Bionics’ proprietary bi-hormonal pump and pump systems.
Year-to-Date 2024 Financial Results
Six Months Ended June 30,
Change
2024
2023
$
%
Product revenue (in thousands):
Gvoke
$
36,625
$
30,671
$
5,954
19.4
Keveyis
26,213
26,843
(630
)
(2.3
)
Recorlev
23,937
11,644
12,293
105.6
Product revenue, net
86,775
69,158
17,617
25.5
Royalty, contract and other revenue
1,928
2,046
(118
)
(5.8
)
Total revenue
$
88,703
$
71,204
$
17,499
24.6
Gvoke
®
: Net revenue was $36.6 million for the six months ended June 30, 2024, a 19% increase compared to prior year. Gvoke prescriptions for the first half of 2024 were approximately 124,000 TRx’s, growing approximately 27% compared to the same period in 2023.
Keveyis
®
: Net revenue was $26.2 million for the six months ended June 30, 2024, a 2% decrease from last year due to generic competition.
Recorlev
®
: Net revenue was $24.0 million for the six months ended June 30,2024, a 106 % increase from last year, driven primarily by increases in the number of patients on therapy.
Cost of goods sold
remained relatively flat for the three months ended June 30, 2024 compared to the same period ended June 30, 2023. Cost of goods sold increased by $0.9 million for the six months ended June 30, 2024 compared to the same period ended June 30, 2023. The slight increase was attributable to higher product sales, partially offset by favorable product mix driven by higher sales of products with lower cost of goods sold.
Research and development (R&D) expenses
decreased slightly by $0.3 million for the three months ended June 30, 2024. For six months ended June 30, 2024, R&D increased by $2.7 million primarily due to higher spending for our pipeline and personnel related expenses.
Selling, general and administrative (SG&A) expenses
increased by $2.4 million and $7.1 million for the three and six months ended 2024, respectively, compared to the same periods ended June 30, 2023, due to higher personnel costs.
Net Loss
for the three months ended June 30, 2024, was $15.0 million, or $0.10 per share, and a net loss of $34.0 million, or $0.24 per share, for the six months ended June 30, 2024.
Cash, cash equivalents, and short-term investments
at June 30, 2024 was $77.6 million compared to $72.5 million at December 31, 2023. Total shares outstanding at July 31, 2024 was 148,998,825.
Upcoming Investor Conferences
Members of the senior management team will be participating in the following investor conferences:
Wells Fargo Healthcare Conference, September 4-6, 2024
HC Wainwright Global Investor Conference, September 9-11, 2024
Cantor Global Healthcare Conference, September 17-19, 2024
Please check with each conference sponsor to arrange 1x1 meetings.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results.
To pre-register for the call, please go to the following link:
https://www.netroadshow.com/events/login?show=44e9222b&confId=68537
After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, August 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 840547
To join the webcast, please visit “Events” on investor relations page of the Company’s website at
www.xerispharma.com
or use this link:
https://events.q4inc.com/attendee/670337574
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke
®
, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis
®
, a proven therapy for primary periodic paralysis, and Recorlev
®
for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect
®
, supporting long-term product development and commercial success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit
www.xerispharma.com
, or follow us on
X
,
LinkedIn
, or
Instagram
.
Forward-Looking Statements
Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, including projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the expected timing of an end-of-Phase 2 meeting with the FDA, its attendance at investor conferences, the composition of its executive team, and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2024
2023
2024
2023
Product revenue, net
$
46,512
$
36,893
$
86,775
$
69,158
Royalty, contract and other revenue
1,553
1,115
1,928
2,046
Total revenue
48,065
38,008
88,703
71,204
Costs and expenses:
Cost of goods sold
7,790
7,555
13,761
12,874
Research and development
5,759
6,087
13,580
10,925
Selling, general and administrative
39,993
37,635
78,373
71,240
Amortization of intangible assets
2,710
2,710
5,421
5,421
Total costs and expenses
56,252
53,987
111,135
100,460
Loss from operations
(8,187
)
(15,979
)
(22,432
)
(29,256
)
Other expense
(6,069
)
(4,538
)
(10,497
)
(8,095
)
Net loss before benefit from income taxes
(14,256
)
(20,517
)
(32,929
)
(37,351
)
Income tax (expense) benefit
(749
)
675
(1,056
)
675
Net loss
$
(15,005
)
$
(19,842
)
$
(33,985
)
$
(36,676
)
Net loss per common share - basic and diluted
$
(0.10
)
$
(0.14
)
$
(0.24
)
$
(0.27
)
Weighted average common shares outstanding - basic and diluted
148,345,549
137,338,071
144,372,512
137,250,465
XERIS BIOPHARMA HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, 2024
December 31, 2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
57,604
$
67,449
Short-term investments
19,964
5,002
Trade accounts receivable, net
42,440
39,197
Inventory
42,977
38,838
Prepaid expenses and other current assets
7,355
5,778
Total current assets
170,340
156,264
Property and equipment, net
5,833
5,971
Intangible assets, net
104,343
109,764
Goodwill
22,859
22,859
Operating lease right-of-use assets
22,864
23,204
Other assets
5,494
4,540
Total assets
$
331,733
$
322,602
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
5,798
$
11,565
Current operating lease liabilities
5,307
3,495
Other accrued liabilities
23,494
23,510
Accrued trade discounts and rebates
23,275
22,149
Accrued returns reserve
16,197
14,198
Current portion of contingent value rights
420
19,109
Other current liabilities
997
1,167
Total current liabilities
75,488
95,193
Long-term debt, net of unamortized debt issuance costs
230,481
190,932
Non-current contingent value rights
—
1,379
Non-current operating lease liabilities
34,016
34,764
Deferred tax liabilities
3,324
2,268
Other liabilities
7,710
4,848
Total liabilities
351,019
329,384
Total stockholders’ equity (deficit)
(19,286
)
(6,782
)
Total liabilities and stockholders’ equity (deficit)
$
331,733
$
322,602
License out/inClinical ResultFinancial StatementPhase 2
100 Deals associated with Levoketoconazole
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10950 | Levoketoconazole | - |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Endogenous Cushing Syndrome | US | 30 Dec 2021 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Endogenous Cushing Syndrome | Phase 3 | US | 01 Aug 2014 | |
| Endogenous Cushing Syndrome | Phase 3 | NL | 01 Aug 2014 | |
| Endogenous Cushing Syndrome | Phase 3 | PL | 01 Aug 2014 | |
| Endogenous Cushing Syndrome | Phase 3 | ES | 01 Aug 2014 | |
| Endogenous Cushing Syndrome | Phase 3 | FR | 01 Aug 2014 | |
| Endogenous Cushing Syndrome | Phase 3 | BG | 01 Aug 2014 | |
| Endogenous Cushing Syndrome | Phase 3 | IL | 01 Aug 2014 | |
| Diabetes Mellitus, Type 2 | Phase 3 | NZ | 01 Jan 2008 | |
| Diabetes Mellitus, Type 2 | Phase 3 | AU | 01 Jan 2008 | |
| Diabetes Mellitus, Type 2 | Discovery | US | 01 Jan 2008 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Corporate Publications Manual  | Phase 3 | 79 | woxihjwbje(xoowfbmrqf) = jvtxywcfyx ssyurljjpv (siljvvwifr ) View more | Positive | 12 May 2022 | ||
Placebo | woxihjwbje(xoowfbmrqf) = rqxsknxdng ssyurljjpv (siljvvwifr ) View more | ||||||
Phase 3 | 94 | moykgoamhp(czlgnzlfda) = djloralsol xjogyhktcj (krlfiamxue, mqmdnjjmhb - fnvxqvuxzr) View more | - | 19 Apr 2021 | |||
Phase 3 | 94 | (Patients with DM) | chatwnxruh(obibwwzgbc): P-Value = 0.0006 View more | - | 01 Jan 2021 | ||
(Patients without DM) | |||||||
Phase 3 | 44 | akoowhdtux(neaezaihbh) = dkxurwrqcz pykgrlybyh (yorpcgkurb ) View more | Positive | 08 Sep 2020 | |||
placebo | akoowhdtux(neaezaihbh) = tatplykuvk pykgrlybyh (yorpcgkurb ) View more |
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