Daewoong Pharmaceutical Reports Third Quarter 2023 Financial Results

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• USA - English

SEOUL, South Korea, Nov. 1, 2023 /PRNewswire/ -- Daewoong Pharmaceutical (KRX: 069620.KS) is pleased to announce its financial results for the third quarter of 2023. Demonstrating a consistent growth trajectory, the company achieved stand-alone sales of KRW 303 billion and an impressive operating profit of KRW 34.2 billion.

Key Growth Drivers - Novel Drugs Developed by Daewoong Pharmaceutical -

• Fexuclue(ingredient: Fexuprazan), a drug for GERD, has seen robust growth with sales reaching KRW 55 billion. It has submitted NDA applications in 12 countries, notably including the Philippines, China and now approved in three Latin American countries, including the Ecuador, Chile, and Mexico. 
• Envlo(ingredient: Enavogliflozin), the South Korea's first SGLT-2 inhibitor, is reshaping the market for diabetes treatment and expanding its product line up through aggressive development of combination drug. Envlo accomplished to submit the NDA in five countries such as Indonesia, Philippines, Thailand, Vietnam and Saudi Arabia only within six months after official launch in domestic market.
• NABOTA (ingredient: Botulinumtoxin Type A), the Asia's first FDA-approved botulinum toxin, is experiencing steady growth and broadening its global presence through its partner, Evolus. Now known as Nuceiva in Europe, it has successfully launched in the UK, Germany, Austria, and recently in Italy, solidifying its presence in North America and Europe. Furthermore, AEON Biopharma, with Daewoong Pharmaceutical as its second-largest shareholder, secured a U.S. patent for migraine headache treatment in last September.

Clinical Development Updates -First-in-class or Best-in Class-

• DWP213388, targeting both BTK and ITK for immune cell activation, has received approval for U.S. Phase 1 Clinical Trials. The FDA endorsed its IND application in August, highlighting its potential in autoimmune diseases such as RA.
• Bersiporocin, focusing on the PARS1 enzyme essential for collagen synthesis, is progressing through Phase 2 trials in the US and Korea. With its potential anti-fibrotic benefits, Daewoong remains dedicated to ensuring its safe use. The drug has achieved FDA's Orphan Drug and Fast Track Designations for IPF. 
• DWRX2008, a novel drug candidate from Daewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical Group, aims to revolutionize the treatment of diabetic retinopathy by transitioning Envlo from oral administration to an innovative ocular pathway. As it is the first-in-class development, DWRX2008 secured approval from the Ministry of Food and Drug Safety (MFDS) to commence Phase 1 clinical trials for its innovative candidate targeting diabetic eye diseases.
• DWP306001, which incorporates Envlo, is in development as a potential treatment for obesity. The combination of Envlo with an appetite suppressant is set to enter Phase 2 clinical trials later this year.

FINANCIAL HIGHLIGHTS

Key Highlights (Unconsolidated) (unit: KRW Billion)

Sales recorded 303 billion won in the third quarter of 2023, a 0.52 percent increase compared to the same period in the previous year. Strong sales growth from ETC pharmaceuticals continued from major products sold under the names of Fexuclue, Envlo, and Nabota.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

SOURCE Daewoong Pharmaceutical Co., Ltd.