Latest news with #OrionCorporation
Business Standard
23-05-2025
- Business
- Business Standard
Shilpa Medicare zooms as arm partners with Orion Corporation
Shilpa Medicare jumped 7.88% to Rs 792.90 after its wholly owned subsidiary, Shilpa Biocare, entered into a strategic partnership with Orion Corporation to commercialise Recombinant Human Albumin in Europe. Under this strategic agreement, Orion Corporation will serve as the exclusive partner for the distribution, marketing, and sales of Shilpas Recombinant Human Albumin in Europe. As part of the deal, Shilpa is entitled to receive development and regulatory milestone payments from Orion. Shilpa has been investing in the development of this novel product for approximately eight years, including the establishment of a large-scale fermentation facility designed to manufacture recombinant human albumin. This facility aims to meet the global demand for this life-saving drug. The collaboration with Orion marks a major milestone in Shilpas expansion into the global biosimilar and biopharmaceutical markets, leveraging Orions strong regional presence, regulatory expertise, and established commercial infrastructure. The firm stated that Orion Corporation is not a related party to the company, Shilpa Biocare (SBPL), or any of the promoter/promoter group/group companies. Recombinant Human Albumin is a key plasma protein used in various therapeutic applications and as a critical component in vaccine and biologics manufacturing. Shilpa Medicares recombinant human albumin is developed using a robust non-human expression system, ensuring high safety, scalability, and virus-free production, effectively addressing key limitations associated with human-derived albumin. This partnership reinforces both companies commitment to advancing biotechnology-driven therapies and improving patient access to safer, sustainable, and next-generation biologics. Madhav Bhutada, Managing Director, Shilpa Biocare, said, partnering with Orion is a significant step in bringing our innovative recombinant product to patients across Europe and is a testimonial of our developmental & manufacturing capabilities to bring recombinant human albumin to market. This alliance aligns with our mission to provide high-quality, affordable biologics globally, and we are confident this partnership will further accelerate our footprint in the regulated markets. Satu Ahomi, EVP Generics and Consumer Health, Orion Corporation, said, We are pleased to strengthen our strategic partnership with Shilpa by collaborating on this novel product. Recombinant human albumin will strengthen our strategy and offering in value-add hospital generics, and we look forward to making it available across Europe. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company had reported a consolidated net profit of Rs 31.78 crore in Q3 FY25, which is significantly higher as compared with the PAT of Rs 4.58 crore posted in Q3 FY24. Revenue from operations for the third quarter was at Rs 319.32 crore, up 11.35% year on year.
Yahoo
23-05-2025
- Business
- Yahoo
Orion announces agreement with Shilpa Medicare for Recombinant Human Albumin for European market
ORION CORPORATION PRESS RELEASE 23 MAY 2025 at 12.40 EEST Orion announces agreement with Shilpa Medicare for Recombinant Human Albumin for European market Orion Corporation and Shilpa Biocare Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited ('Shilpa'), have entered into an agreement to commercialise Recombinant Human Albumin in Europe. Recombinant Human Albumin is a key plasma protein used in various therapeutic applications. Shilpa's Recombinant Human Albumin is developed using a robust non-human expression system ensuring high safety, scalability, and virus-free production, addressing key limitations associated with human-derived albumin. The product is currently under development by Shilpa. Under the terms of the agreement, Orion will gain exclusive right to distribute, market and sell Shilpa's Recombinant Human Albumin in Europe. Shilpa is entitled to receive from Orion certain development and regulatory milestone payments. 'We are pleased to strengthen our strategic partnership with Shilpa by collaborating on this novel product,' said Satu Ahomäki, EVP Generics and Consumer Health, Orion Corporation. 'Recombinant human albumin will strengthen our strategy and offering in value-add hospital generics, and we look forward to making it available across Europe.' 'Partnering with Orion is a significant step in bringing our innovative recombinant product to patients across Europe and is a testimonial of our developmental and manufacturing capabilities to bring Recombinant Human Albumin to market,' said Madhav Bhutada, Managing Director, Shilpa Biocare. 'This alliance aligns with our mission to provide high-quality, affordable biologics globally, and we are confident this partnership will further accelerate our footprint in the regulated markets.' Orion Corporation Contact person:Satu Ahomäki, EVP, Generics and Consumer Health, Orion Corporation tel. +358 10 426 7616 Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandhttp:// Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki.
Yahoo
23-05-2025
- Business
- Yahoo
Orion announces agreement with Shilpa Medicare for Recombinant Human Albumin for European market
ORION CORPORATION PRESS RELEASE 23 MAY 2025 at 12.40 EEST Orion announces agreement with Shilpa Medicare for Recombinant Human Albumin for European market Orion Corporation and Shilpa Biocare Private Limited, a fully-owned subsidiary of Shilpa Medicare Limited ('Shilpa'), have entered into an agreement to commercialise Recombinant Human Albumin in Europe. Recombinant Human Albumin is a key plasma protein used in various therapeutic applications. Shilpa's Recombinant Human Albumin is developed using a robust non-human expression system ensuring high safety, scalability, and virus-free production, addressing key limitations associated with human-derived albumin. The product is currently under development by Shilpa. Under the terms of the agreement, Orion will gain exclusive right to distribute, market and sell Shilpa's Recombinant Human Albumin in Europe. Shilpa is entitled to receive from Orion certain development and regulatory milestone payments. 'We are pleased to strengthen our strategic partnership with Shilpa by collaborating on this novel product,' said Satu Ahomäki, EVP Generics and Consumer Health, Orion Corporation. 'Recombinant human albumin will strengthen our strategy and offering in value-add hospital generics, and we look forward to making it available across Europe.' 'Partnering with Orion is a significant step in bringing our innovative recombinant product to patients across Europe and is a testimonial of our developmental and manufacturing capabilities to bring Recombinant Human Albumin to market,' said Madhav Bhutada, Managing Director, Shilpa Biocare. 'This alliance aligns with our mission to provide high-quality, affordable biologics globally, and we are confident this partnership will further accelerate our footprint in the regulated markets.' Orion Corporation Contact person:Satu Ahomäki, EVP, Generics and Consumer Health, Orion Corporation tel. +358 10 426 7616 Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandhttp:// Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
Orion to host Capital Markets Day today, 22 May 2025, in Helsinki
ORION CORPORATION INVESTOR NEWS 22 MAY 2025 at 10.15 EEST Orion to host Capital Markets Day today, 22 May 2025, in Helsinki Orion hosts its Capital Markets Day for analysts, institutional investors, bankers, and media representatives in Helsinki today, 22 May 2025. At the event, members of the Orion Executive Management Board will discuss Orion's growth strategy, financial objectives, and businesses. Orion will not publish new strategic or financial targets in connection with the event. The presentation material is now published on Orion's website The presentations include, among other things, the following information, which is of interest to investors, but is not considered to be material information about the company. In the next 12 to 24 months, Orion aims to start clinical phase I trials with ODM-214, ODM-215 and ODM-216 which all are biologics (large molecule) and originate from Orion's internal research. Easyhaler® product portfolio has potential to exceed EUR 300 million in peak annual sales. Orion has three biologics assets for immuno-oncology indications in late research (candidate drug) phase. The company aims to start clinical phase I trials with these assets in the next 12 to 24 months. Of the assets ODM-2014 and ODM-216 are bi-specific antibodies and ODM-215 is a CAR-T cell therapy. The growth of Easyhaler® product portfolio for asthma and COPD is supported by the green transition. Dry-powder inhalers are becoming the preferred choice over metered-dose inhalers due to lower CO2 emissions. Also, the entire market is growing along with the growing number of patients. Orion is well positioned in this market and estimates that Easyhaler® product portfolio has potential to exceed EUR 300 million in peak annual sales. Orion's Capital Markets Day starts at 13:00 EEST and anyone can follow the event via a live webcast at Orion Corporation Contact person:Tuukka Hirvonen, Investor Relations, Orion Corporationtel. +358 10 426 2721 Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Finlandhttp:// Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
08-05-2025
- Business
- Business Wire
OmniAb Reports First Quarter 2025 Financial Results and Business Highlights
BUSINESS WIRE)-- OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three months ended March 31, 2025, and provided operating and partner program updates. 'We have started the year with robust deal flow, including both platform and asset-based deals. Our business remains strong as our diversified pipeline of partner programs is progressing with recent and expected new clinical entrants and data readouts,' said Matt Foehr, Chief Executive Officer of OmniAb. 'Today we announced the xPloration® Partner Access Program for OmniAb partners, enhancing the scalability of our technology platforms and creating new business opportunities that we believe will be accretive to both earnings and cash flow in short- and long-term. This initiative furthers our mission to push the frontiers of discovery technologies along with our focus on creating value for our partners and our stakeholders. As we look ahead, our 2025 outlook remains on track with our commitment to running an efficient and leverageable business.' First Quarter 2025 Financial Results Revenue for the first quarter of 2025 was $4.2 million, compared with $3.8 million for the same period in 2024, with the increase primarily due to the recognition of a $1.0 million Phase 1 milestone payment and higher license fees, partially offset by lower service revenue. Research and development expense was $12.6 million for the first quarter of 2025, compared with $14.6 million for the same period in 2024, with the decrease primarily due to lower share-based compensation expense and lower external expenses associated with our small-molecule ion channel programs and technology development. General and administrative expense was $7.9 million for the first quarter of 2025, compared with $8.3 million for the same period in 2024, with the decrease primarily due to lower legal fees and share-based compensation expense. Net loss for the first quarter of 2025 was $18.2 million, or $0.17 per share, compared with a net loss of $19.0 million, or $0.19 per share, for the same period in 2024. As of March 31, 2025, OmniAb had cash, cash equivalents and short-term investments of $43.6 million. 2025 Financial Guidance OmniAb affirms guidance for 2025 revenue to be in the range of $20 million to $25 million, and revises operating expense guidance to be in the range of $85 million to $90 million from the previous range of $90 million to $95 million. In addition, OmniAb continues to expect 2025 cash use to be lower than cash use in 2024. Cash use in 2024 was $38.9 million, excluding the 2024 ATM issuance. The 2025 full year effective tax rate is expected to be approximately 0%. First Quarter 2025 and Recent Business Highlights During the first quarter of 2025, OmniAb entered into three new platform license agreements including the Wyss Institute at Harvard University, Takis Biotech S.r.l. and Orion Corporation. OmniAb entered into a research collaboration and license agreement with Orion Corporation to discover and generate an antibody-based compound for a specific ion-channel target. Under the terms of the agreement, OmniAb will receive an upfront payment of $250,000 and is eligible to receive service payments. OmniAb is also eligible to receive development, regulatory and commercialization milestone payments totaling to over $55 million. OmniAb will receive low- to mid-single digit tiered royalties on net sales, should the program reach commercialization. As of March 31, 2025, the Company had 95 active partners and 378 active programs, including 33 OmniAb-derived programs in clinical development or being commercialized. Post-quarter close, OmniAb entered into an asset-based sale with Angelini Pharma for a small molecule Kv7.2 program. OmniAb will receive an upfront payment of $3 million, and potential milestones of over $170 million and royalties. In addition, OmniAb launched the offering of xPloration to existing partners through a Partner Access Program. xPloration is a high-throughput single B-cell screening instrument that leverages machine learning and artificial intelligence to address challenges in primary B-cell screening with traditional methods, such as limited antibody diversity and lengthy processes. We believe it offers a competitive edge over current market offerings for B-cell screening with unmatched screening throughput, superior hit recovery, exceptional ease-of-use and reliability. OmniAb will showcase xPloration at the 21 st Annual PEGS Boston Summit, taking place May 12-16 at the Omni Boston Hotel at the Seaport. First quarter 2025 and recent partner and business highlights include the following: IMVT-1402 Immunovant announced that potentially registrational trials for IMVT-1402 are currently enrolling patients in four indications: myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Graves' disease (GD) and difficult-to-treat rheumatoid arthritis. A fifth potentially registrational trial for Sjogren's disease is planned to begin in the summer of 2025. Additionally, a proof-of-concept study has been initiated in a sixth indication, cutaneous lupus erythematosus. Batoclimab Immunovant announced positive study results for batoclimab in MG and CIDP. The pivotal study in MG met its primary endpoint, showing a change from baseline in the Myasthenia Gravis Activities of Daily Living score in the acetylcholine receptor antibody positive population at 12 weeks. The 680mg dose arm showed a 5.6-point improvement with a 74% mean immunoglobulin G (IgG) reduction, while the 340mg dose arm showed a 4.7-point improvement with a 64% mean IgG reduction. Initial CIDP results from Period 1, following standard-of-care washout, demonstrated a mean improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score of 1.8 across study arms. An 84% responder rate (with response defined as an aINCAT improvement ≥1) was observed among all patients whose IgG was reduced by ≥70%. In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints. Immunovant expects to announce additional data for batoclimab in GD, including six-month remission data, this summer. Additionally, top-line results for batoclimab from potentially registrational Phase 3 trials in thyroid eye disease are expected in the second half of 2025. Sugemalimab CStone Pharmaceuticals announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab, seeking approval for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) in patients who have not progressed following platinum-based chemoradiotherapy. This is CStone's second regulatory submission for sugemalimab to the EMA, following its 2024 approval for metastatic NSCLC. TEV-53408 Teva Pharmaceuticals initiated a Phase 2 trial of TEV-53408 in adults with celiac disease. The primary efficacy objective is to assess the ability of TEV-53408 to attenuate gluten-induced enteropathy. Additional objectives include the safety assessment of TEV-53408. RNDO- 564 Rondo Therapeutics published preclinical data for RNDO-564, a CD28 x Nectin-4 bispecific antibody for bladder cancer, in the Journal of Immunotherapy of Cancer. In vitro studies demonstrated that RNDO-564 enhanced T-cell activation and cytotoxicity against Nectin-4 positive tumor cells. The antibody demonstrated significant tumor regression in tumor-bearing mouse models, both alone and with an immune checkpoint inhibitor. Favorable pharmacokinetic and tolerability profiles were observed in non-human primates. OmniAb recently appointed Philip J. Gotwals, Ph.D., and Steve Crouse to its Board of Directors. Dr. Gotwals, with 30 years of biopharmaceutical experience in R&D, business development, product development, and therapeutic area strategy, along with Mr. Crouse, who brings over 20 years of expertise in life sciences sales and marketing, product development, business development, and general management, will help advance the Company's strategic initiatives. OmniAb reported that partners presented data on nine OmniAb derived molecules at the American Association for Cancer Research Annual Meeting 2025, held April 25-30. These presentations showcased clinical trial designs, as well as data across various preclinical and clinical studies. The Company also expects that multiple partners will be presenting data from programs developed with OmniAb technology at the American Society of Clinical Oncology Annual Meeting taking place May 30 - June 3, 2025. Conference Call and Webcast OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549 8228 using the conference ID 96760. Slides, as well as the live and replay webcast of the call, are available at About OmniAb ® OmniAb licenses cutting edge discovery research technology to pharmaceutical and biotech companies and academic institutions to enable the discovery of next-generation therapeutics. Our technology platform creates and screens diverse antibody repertoires and is designed to quickly identify optimal antibodies and other target-binding proteins for our partners' drug development efforts. At the heart of the OmniAb platform is something we call Biological Intelligence™, which powers the immune systems of our proprietary, engineered transgenic animals to create optimized antibody candidates for human therapeutics. We believe the OmniAb animals comprise the most diverse host systems available in the industry. Our suite of technologies and methods, including computational antigen design and immunization methods, paired with high-throughput single B-cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms, is used to identify fully-human antibodies with exceptional performance and developability characteristics. We provide our partners both integrated end-to-end capabilities and highly customizable offerings, which address critical industry challenges and provide optimized discovery solutions. Our business model aligns scientific and economic interests of our partners through structured agreements that generally include upfront/access fees, service revenue, milestones and royalties on commercial sales. For more information, please visit Forward-Looking Statements OmniAb cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. Words such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplates,' 'believes,' 'estimates,' 'predicts,' 'potential' or continue' and similar expressions, are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: statements regarding our competitive advantage and the growth prospects of our business; the scalability of our business; the expected performance of our technologies and the opportunities and earnings and cash flow accretion they may create, including the xPloration Partner Access Program; the ability to add new partners and programs; scientific presentations and clinical and regulatory events of our partners and the timing thereof; and our 2025 financial guidance. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future success is dependent on acceptance of our technology platform and technologies by new and existing partners, as well as on the eventual development, approval and commercialization of products developed by our partners for which we have no control over the development plan, regulatory strategy or commercialization efforts; biopharmaceutical development is inherently uncertain; risks arising from changes in technology; the competitive environment in the life sciences and biotechnology platform market; risks associated with quality and timing in manufacturing our xPloration instruments and related consumables and our reliance on a limited number of third-party manufacturers and suppliers; our failure to maintain, protect and defend our intellectual property rights; difficulties with performance of third parties we will rely on for our business; regulatory developments in the United States and foreign countries; unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price; we may use our capital resources sooner than we expect; and other risks described in our prior press releases and filings with the SEC, including under the heading 'Risk Factors' in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. [Tables Follow] OMNIAB, INC. (in thousands, except share and per share data) December 31, 2024 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 10,892 $ 27,598 Short-term investments 32,703 31,836 Accounts receivable, net 6,478 5,272 Prepaid expenses and other current assets 3,505 3,432 Total current assets 53,578 68,138 Intangible assets, net 134,833 138,060 Goodwill 83,979 83,979 Property and equipment, net 14,711 15,492 Operating lease right-of-use assets 17,239 17,789 Restricted cash 560 560 Other long-term assets 1,282 1,540 Total assets $ 306,182 $ 325,558 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,933 $ 2,297 Accrued expenses and other current liabilities 3,582 6,141 Current contingent liabilities 353 531 Current deferred revenue 1,726 2,337 Current operating lease liabilities 3,813 3,782 Total current liabilities 11,407 15,088 Long-term contingent liabilities 297 953 Deferred income taxes, net 2,208 2,314 Long-term operating lease liabilities 18,666 19,382 Long-term deferred revenue — 117 Other long-term liabilities 88 86 Total liabilities 32,666 37,940 Stockholders' equity: Preferred stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024 — — Common stock, $0.0001 par value; 1,000,000,000 shares authorized at March 31, 2025 and December 31, 2024; 122,134,941 and 121,599,488 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 12 12 Additional paid-in capital 393,096 388,979 Accumulated other comprehensive income 8 27 Accumulated deficit (119,600 ) (101,400 ) Total stockholders' equity 273,516 287,618 Total liabilities and stockholders' equity $ 306,182 $ 325,558 Expand OMNIAB, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) Three Months Ended March 31, 2025 2024 Revenue: License and milestone revenue $ 2,021 $ 716 Service revenue 1,945 2,766 Royalty revenue 188 319 Total revenue 4,154 3,801 Operating expenses: Research and development 12,602 14,551 General and administrative 7,915 8,337 Amortization of intangibles 3,228 3,412 Other operating expense (income), net (747 ) 54 Total operating expenses 22,998 26,354 Loss from operations (18,844 ) (22,553 ) Other income (expense), net: Interest income 537 975 Other income, net 1 — Total other income (expense), net 538 975 Loss before income taxes (18,306 ) (21,578 ) Income tax benefit 106 2,617 Net loss $ (18,200 ) $ (18,961 ) Net loss per share, basic and diluted $ (0.17 ) $ (0.19 ) Weighted-average shares outstanding, basic and diluted 105,622 100,755 Expand
