Evoke Pharma, Inc. Reports Third Quarter 2024 Financial Results
Evoke Pharma reported strong Q3 2024 results with record-breaking GIMOTI net product sales of $2.7 million, marking a 70% year-over-year increase. The company saw significant growth with a 45% increase in prescribers and 52% rise in prescription fills year-over-year. Real-world data presented at ACG 2024 showed GIMOTI's effectiveness for patients on GLP-1 therapy. The company revised its 2024 guidance to $9.5-10.0 million from $11-12 million. As of September 30, cash and equivalents stood at $11.3 million, with an additional $3.5 million raised in October through warrant exercises, extending operations into Q4 2025.
Evoke Pharma ha riportato risultati solidi per il terzo trimestre del 2024 con vendite nette di prodotto GIMOTI pari a 2,7 milioni di dollari, segnando un aumento del 70% rispetto all'anno precedente. L'azienda ha visto una crescita significativa con un aumento del 45% nel numero di prescrittori e un incremento del 52% nelle prescrizioni anno su anno. I dati del mondo reale presentati all'ACG 2024 hanno dimostrato l'efficacia di GIMOTI per i pazienti in terapia GLP-1. L'azienda ha rivisto la sua previsione per il 2024, portandola a $9,5-10,0 milioni, rispetto ai $11-12 milioni precedentemente stimati. Al 30 settembre, contanti e equivalenti ammontavano a 11,3 milioni di dollari, con ulteriori 3,5 milioni di dollari raccolti a ottobre attraverso l'esercizio di warrant, estendendo così le operazioni fino al quarto trimestre del 2025.
Evoke Pharma informó resultados sólidos para el tercer trimestre de 2024 con ventas netas récord del producto GIMOTI de $2.7 millones, marcando un aumento del 70% en comparación con el año anterior. La compañía experimentó un crecimiento significativo con un aumento del 45% en los prescritores y un incremento del 52% en las recetas llenas en comparación con el año anterior. Los datos del mundo real presentados en el ACG 2024 demostraron la efectividad de GIMOTI para los pacientes en terapia con GLP-1. La compañía revisó su guía para 2024 a $9.5-10.0 millones, desde los $11-12 millones. Al 30 de septiembre, el efectivo y equivalentes alcanzaban los $11.3 millones, con $3.5 millones adicionales recaudados en octubre a través de ejercicios de warrants, ampliando así las operaciones hasta el cuarto trimestre de 2025.
에보크 제약은 2024년 3분기 결과를 발표했으며, GIMOTI 제품의 순매출이 270만 달러로 기록적인 성과를 거두어 전년 대비 70% 증가했습니다. 회사는 처방 의사가 45% 증가하고 처방전 처리 건수가 52% 증가하면서 상당한 성장을 경험했습니다. ACG 2024에서 발표된 실제 데이터는 GLP-1 요법을 받고 있는 환자에게 GIMOTI의 효과를 보여주었습니다. 회사는 2024년 가이드를 1100만-1200만 달러에서 950만-1000만 달러로 수정했습니다. 9월 30일 기준으로 현금 및 현금성 자산은 1130만 달러였으며, 10월에는 보증서를 통해 추가로 350만 달러를 모금하여 2025년 4분기까지 운영을 연장했습니다.
Evoke Pharma a rapporté de solides résultats pour le troisième trimestre 2024, avec des ventes nettes record de produits GIMOTI atteignant 2,7 millions de dollars, marquant une augmentation de 70 % par rapport à l'année précédente. L'entreprise a connu une croissance significative avec une augmentation de 45 % des prescripteurs et une hausse de 52 % des prescriptions remplies en glissement annuel. Les données du monde réel présentées à l'ACG 2024 ont montré l'efficacité de GIMOTI pour les patients sous traitement GLP-1. L'entreprise a révisé ses prévisions pour 2024 à 9,5-10,0 millions de dollars, contre 11-12 millions de dollars précédemment estimés. Au 30 septembre, les liquidités et équivalents s'élevaient à 11,3 millions de dollars, avec des fonds supplémentaires de 3,5 millions de dollars levés en octobre par l'exercice de bons de souscription, prolongeant ainsi les opérations jusqu'au quatrième trimestre 2025.
Evoke Pharma berichtete von starken Ergebnissen im dritten Quartal 2024 mit rekordverdächtigen netto Produktverkäufen von GIMOTI in Höhe von 2,7 Millionen Dollar, was einem Anstieg von 70 % im Jahresvergleich entspricht. Das Unternehmen verzeichnete ein signifikantes Wachstum mit einem Anstieg von 45 % bei den Verschreibern und einem Anstieg von 52 % bei den Rezepten im Vergleich zum Vorjahr. Die präsentierten Daten aus der realen Welt bei der ACG 2024 zeigten die Wirksamkeit von GIMOTI für Patienten, die eine GLP-1-Therapie erhalten. Das Unternehmen hat seine Prognose für 2024 auf 9,5 bis 10,0 Millionen Dollar von 11 bis 12 Millionen Dollar nach unten revidiert. Zum 30. September betrugen die Bargeldbestände und Äquivalente 11,3 Millionen Dollar, wobei im Oktober zusätzlich 3,5 Millionen Dollar durch die Ausübung von Optionen gesammelt wurden, um die Geschäftstätigkeit bis ins vierte Quartal 2025 auszudehnen.
- Record quarterly revenue of $2.7M, up 70% year-over-year
- 45% increase in prescriber base year-over-year
- 52% increase in prescription fills year-over-year
- Strong cash position of $11.3M plus additional $3.5M from warrant exercises
- Operational runway extended into Q4 2025
- Downward revision of 2024 revenue guidance from $11-12M to $9.5-10M
- Q3 net loss of $1.3M
- Operating expenses increased to $3.9M from $3.2M year-over-year
Insights
EVOK's Q3 results show significant progress with
The balance sheet appears stable with
Despite revenue growth, operating expenses increased to
The ACG 2024 data presentation marks a significant milestone, demonstrating GIMOTI's effectiveness in patients using GLP-1 medications - a rapidly growing market segment. The Presidential Poster Award recognition validates the clinical significance of these findings. The
The nasal delivery system bypassing the dysfunctional stomach represents a key competitive advantage over oral medications. Medicare and Medicaid coverage for
GIMOTI third quarter net product sales of
Strong cumulative prescriber growth,
Real-world data presented at ACG 2024 demonstrates that GIMOTI significantly enhanced outcomes for patients on GLP-1 therapy, marking it as a promising supportive care option compared to oral metoclopramide.
SOLANA BEACH, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its financial results for the third quarter ended September 30, 2024, and recent corporate developments.
“We are encouraged by the strong year-over-year growth metrics we continue to see for GIMOTI, including a
“The recent data presented at ACG 2024 highlights GIMOTI’s ability to significantly reduce healthcare visits, including hospitalizations, underscoring the need for better alternatives to traditional oral treatments. Coupled with our strategic initiatives to expand access and engage more prescribers, we are well-positioned to increase GIMOTI’s reach and help more patients find meaningful relief. The positive feedback from both patients and providers strengthens our resolve to reshape the care paradigm and ensure that people with gastroparesis have access to an effective and innovative option like GIMOTI,” said Chris Quesenberry, Chief Commercial Officer of GIMOTI.
“Our dedicated mission is to challenge the notion that gastroparesis 'patients are doing fine' with current treatment options, as we know firsthand that many individuals with diabetic gastroparesis continue to struggle despite existing therapies. According to a survey from IFFGD (gastroenterology patient support organization),
Third Quarter 2024 and Year-to-Date Developments and Recent Highlights:
- Continued Commercial Progress with GIMOTI
- Strengthened patient access and streamlined prescription processing with the addition of multiple pharmacy partners, expanding GIMOTI’s reimbursement coverage and availability across key geographic areas.
- Improved insurance reimbursement rates, reducing patient reliance on savings programs due to increased prescription coverage; Medicare and Medicaid programs accounted for approximately
34% of filled GIMOTI prescriptions in the first nine months of 2024, supporting accessibility for a broader patient demographic.
- Compelling Data Unveiled at American College of Gastroenterology 2024 Meeting in October
- Presented posters with data showing statistically significant improvement in patient outcomes for GLP-1 users with diabetic gastroparesis while taking GIMOTI.
- Poster won the Presidential Poster Award as one of the top
5% of data accepted by the conference and also selected as the Outstanding Research Award in the Stomach Category.
- Robust Balance Sheet with Extended Runway
- As of September 30, the Company had cash and cash equivalents of approximately
$11.3 million which includes approximately$10.8 million from warrant exercise financing activities through 3Q 2024. - In October 2024, the Company also raised approximately
$3.5 million through the exercise of warrants by existing investors. - The Company anticipates its current cash on hand will fund its operations into the fourth quarter of 2025.
- As of September 30, the Company had cash and cash equivalents of approximately
- Board of Directors Expansion
- In October 2024, the Company announced the appointment of Ben Smeal to its Board of Directors fulfilling a condition set by Evoke’s existing investor, Nantahala Capital Management in connection with the warrant financing that occurred in September.
Third Quarter 2024 Financial Review and Outlook
For the third quarter of 2024, net product sales were approximately
For the third quarter of 2024, selling, general and administrative expenses were approximately
Total operating expenses for the third quarter of 2024 were approximately
Based on net sales generated in the first three quarters of 2024, Evoke is revising its 2024 guidance to
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis.
Visit www.EvokePharma.com for more information.
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About Gimoti® (metoclopramide) nasal spray
GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information
WARNING: TARDIVE DYSKINESIA
- Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
- Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
- Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.
GIMOTI is not recommended for use in:
- Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
- Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.
GIMOTI is contraindicated:
- In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
- When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).
- In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
- In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
- In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.
Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, including the potential that GIMOTI could become the standard of care for gastroparesis; the potential for additional funds from the exercise of outstanding warrants and Evoke’s expected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: 862-213-1398
dboateng@dkbpartners.net
| Evoke Pharma, Inc. Condensed Balance Sheets | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,339,032 | $ | 4,739,426 | ||||
| Accounts receivable, net of allowance for credit losses of | 2,022,518 | 673,071 | ||||||
| Prepaid expenses | 146,704 | 885,040 | ||||||
| Inventories | 493,408 | 481,840 | ||||||
| Other current assets | 36,421 | 47,532 | ||||||
| Total current assets | 14,038,083 | 6,826,909 | ||||||
| Deferred offering costs | 115,488 | 241,637 | ||||||
| Total assets | $ | 14,153,571 | $ | 7,068,546 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 2,188,164 | $ | 1,711,778 | ||||
| Accrued compensation | 590,634 | 1,324,010 | ||||||
| Note payable | 5,000,000 | 5,000,000 | ||||||
| Accrued interest payable | 1,987,637 | 1,612,295 | ||||||
| Total current liabilities | 9,766,435 | 9,648,083 | ||||||
| Total liabilities | 9,766,435 | 9,648,083 | ||||||
| Commitments and contingencies | ||||||||
| Stockholdersʼ equity (deficit): | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, December 31, 2023, respectively | 89 | 28 | ||||||
| Additional paid-in capital | 131,985,913 | 120,859,873 | ||||||
| Accumulated deficit | (127,598,866 | ) | (123,439,438 | ) | ||||
| Total stockholdersʼ equity (deficit) | 4,387,136 | (2,579,537 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 14,153,571 | $ | 7,068,546 | ||||
| Evoke Pharma, Inc. Condensed Statement of Operations (unaudited) | ||||||||
| Three Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Net product sales | $ | 2,654,186 | $ | 1,562,860 | ||||
| Operating expenses: | ||||||||
| Cost of goods sold | 104,024 | 34,908 | ||||||
| Research and development | 11,677 | — | ||||||
| Selling, general and administrative | 3,824,142 | 3,131,389 | ||||||
| Total operating expenses | 3,939,843 | 3,166,297 | ||||||
| Loss from operations | (1,285,657 | ) | (1,603,437 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 99,294 | 35,558 | ||||||
| Interest expense | (126,027 | ) | (126,028 | ) | ||||
| Total other expense | (26,733 | ) | (90,470 | ) | ||||
| Net loss | $ | (1,312,390 | ) | $ | (1,693,907 | ) | ||
| Net loss per share of common stock, basic and diluted | $ | (0.94 | ) | $ | (6.08 | ) | ||
| Weighted-average shares used to compute basic and diluted net loss per share | 1,399,882 | 278,558 | ||||||
FAQ
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