Bora Pharmaceuticals Exits Integration Phase with Sequentially-Improved Gross and Operating Margins
HONG KONG SAR - Media OutReach Newswire - 14 May 2025 - Bora Pharmaceuticals (TWSE: 6472) today announced its financial results and operational highlights for first quarter of 2025.
Quarterly Business and Financial Highlights
--> Fueled by expanded capacity and new dosage forms, Bora's CDMO business delivered a record high quarter, up 52.4% YoY and 3.0% QoQ.
--> As part of Bora's long-term strategic growth plan, the Company is moving forward with a phased investment of tens of thousands US dollars to unlock the untapped potential of Maple Grove facility. This build-out is designed to enhance capabilities in oral solid dose and sterile manufacturing, strengthening the ability to support customer demand and scale future programs.
--> Pharma Sales revenues rose 82.0% YoY based on reported unaudited monthly sales, driven by strong performance from the vigabatrin franchise, which includes three dosage forms. Notably, VIGAFYDE captured over 70% share in the new patient segment.
--> Due to the completion of Plymouth area decommissioning, consolidated revenues for 1Q25 was NT$4.48 billion, a NT$350 million reversal from the unaudited monthly disclosures, all of which was attributed to the pharma sales segment.
--> Despite margin pressure from partial maintenance shutdowns at the Maryland sterile injectable site in early January and softening demand for generic product dexlansoprazole (DLS), product mix improvement from growing specialty portfolio lifted gross margin from the low of 4Q24 to 42.2% in 1Q25. Tech transfer for 6 Upsher-Smith generic products to cost-competitive sites within Bora network remains on track, with full transfer expected by year-end to support further margin recovery.
--> EPS from continuing operations reached NT$26.54, reflecting NT$2.44 billion of net non-operating income from the divestment of Bora Biologics and recognition of losses of Tanvex Biopharm. However, the decommissioning of the Plymouth area negatively impacted EPS by NT$12.99, resulting in a reported EPS of NT$13.55. Share capital increased 0.4% during the quarter from employee stock option exercises and convertible bond conversions.
--> DLS competitors began exiting the market in early 2Q25 due to supply chain hiccups, creating new opportunities for Bora to increase share and drive recovery momentum.
--> The Group remains optimistic that its first quarter restructuring efforts will increase the long-term value of its recent acquisitions, including unlocking NT$600 million in capital in 2025. CDMO business growth will be further accelerated with strategic U.S.-based capability and capacity.
Mr. Bobby Sheng, Chairman of Bora Group, stated, 'The first quarter is the continuation of critical integration and restructuring phase following multiple business and capacity acquisitions in 2024, laying a solid foundation for operational efficiency expansion. Following substantial investments in the U.S last year, we did observe significant pressure in the U.S. generics space during Q4. This prompted us to swiftly accelerate our integration efforts. At the same time, evolving client dynamics and market demand have only strengthened our conviction in the long-term value and strategic role of these assets. While the organizational streamlining, business separation, and product portfolio optimization undertaken to reflect operational realities have created near-term hurdles, we remain confident that these actions are essential to achieving optimal resource allocation and hence satisfactory return on assets. These efforts are necessary steps in the Company's path toward sustainable mid to long-term growth.
The closure of Plymouth area was completed ahead of schedule during the quarter and the area has thus been reclassified as discontinued operation in our quarterly financial statements altogether. From an operational standpoint, Bora has discontinued 15 products in the U.S. generics market along with the restructure, with an additional 6 products transferred to more cost-efficient manufacturing sites within the Group. On the financial side, discontinued operation resulted in a negative impact of approximately NT$1.34 billion, including overhead, inventory and equipment write-downs as well as severance-related expenses.
Looking ahead, Bora will advance its focus on high-value and complex dosage forms supported by over NT$5.0 billion cash on hand. At Maple Grove, 4 global pharmaceutical clients are currently in advanced discussions regarding CAPEX investments which we view as a strong validation of the site's value and strategic fit. While the timeline for full deployment spans several years, we are approaching this expansion with operational discipline and commercial alignment to ensure its success over time.
On pharma sales side, Bora weathered softness in DLS demand in the first quarter but quickly gained market share as a competitor exited in early second quarter. Generic business rebounded in April, supported by strong sales from new 2024 launches including Potassium Chloride ER Tablets (KCL), and anti-angina drugs Diltiazem (DTC and DTS). This recovery underscores Bora's agility and the resilience of the dual-engine strategy. Furthermore, we have successfully consolidated distribution network for specialty drugs. Bora expects its pediatric spasm product, VIGAFYDE (the 505(b)(2) oral solution), to extend its success in the new patient market into the switch segment in the very near future, supporting future margin and operational leverage expansion.
We continue executing on our goals to scale up, achieve more and integrate smarter, ensuring that both internal and external clients benefit from cost-efficient, regionally aligned manufacturing. By extending the strength of our dual-engine model, we believe Bora shall continue to create above-average total shareholder return.'
1Q2025 Operational Achievements & Full Year Outlook
Global CDMO Operations
Global CDMO Operations (excluding internal orders) delivered record-high revenues of NT$1.90 billion in the first quarter, up 52.4% YoY and representing approximately 39% of total revenue. Including internal orders, CDMO revenue reached NT$2.89 billion. A total of 600 million doses were developed and manufactured. Revenue contribution from global top 20 pharmaceutical companies remained steady at approximately 30%, demonstrating strong clientele and advantage of scale. Bora CDMO continues to be a trusted partner for biotech and pharmaceutical innovators.
--> In 1Q25, the small molecule CDMO pipeline added US$123 million in potential orders and US$78 million in backlog, both marking historic highs.
--> CAPEX progress across sites reached approximately 50%, focused on debottlenecks, efficiency improvement, capacity increase and infrastructure upgrade to align with client and product needs. Flex Pro line at the Maryland sterile injectable facility was completed ahead of schedule and is expected to begin operations in early Q3.
--> Maple Grove launched its first CDMO project during the quarter and is currently negotiating with potential clients while evaluating CAPEX plans for differentiated dosage platforms. Overall, North American capacity transformation is progressing as planned.
--> Large molecule CDMO operation was launched following the January 20 reverse-acquisition of Bora Biologics by Tanvex Biopharm where Bora owns 30.5% of Tanvex. CDMO operations at the San Diego site are now active, and the ongoing 2,000L expansion has received strong interest from late-stage clients. Bora and Tanvex are actively pursuing U.S.-based commercial-scale manufacturing orders with a comprehensive one-stop service model.
Pharma Sales Operations
Pharma Sales Operations revenue reached NT$2.93 billion, representing 82.0% YoY growth and contributing approximately 61% of total revenue based on unadjusted numbers.
--> As the Upsher-Smith team continue to consolidate distributors for specialty drugs, we saw early signs of positive engagement from both market and payer channels at the end of the first quarter. Following the 2024 integration of TWi, Upsher-Smith and Pyros teams, Bora has established a focused pipeline in CNS specialty areas. The company expects to file its first self-developed 505(b)(2) submission for infantile spasms (Stiripentol) with the U.S. FDA by year-end, alongside other pipeline developments.
--> Pediatric epilepsy and TSC-related rare diseases represent the first wave of Bora's pharma sales transformation targets. In addition to reducing over-reliance on generics, high-value rare disease and specialty drugs benefit from strong regulatory and payer support in the specialty pharmacy channel. These markets are less competitive with stable price, and offer targeted access to patient populations, allowing for meaningful long-tail value creation.
Recent Investor Conference
Bora will host an English online earnings call at 7:00 a.m. Taiwan time on May 15, 2025, followed by an investor conference hosted by Taishin Securities at the Grand Hyatt Taipei at 2:00 p.m. on May 16, 2025. Both events will cover the company's Q1'25 financial and business results and outlook.
English Online Earnings Presentation Link: https://www.zucast.com/event/54SiM5il/subscribe/create
The 2025 Annual General Shareholders' Meeting will be held on May 23 at the Tainan Guantian Industrial Marketing Center.
Bora will participate in the Jefferies Global Healthcare Conference in New York on June 4–5. For 1:1 meetings with management, please contact your Jefferies representative.
Bora 2025 Earnings Schedule
Q2 2025: Expected in the 3rd week of August 2025
Q3 2025: Expected in the 3rd week of November 2025
Q4 2025: Expected in the 2nd week of March 2026
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