Acer Therapeutics, Inc.

Launch of OLPRUVA® underway Topline results from KP1077 phase 2 study demonstrate clinically meaningful benefits for key IH symptoms Q4 2023 net revenue of $13.2M, and FY 2023 net revenue of $27.5M Conference call scheduled for today, March 28, 2024, at 4:30 p.m. ET CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra. “As we look to 2024, our strategic priorities are clear; first, successfully launch OLPRUVA® and ensure access for patients; second, prepare for the launch of arimoclomol; and third, advance the KP1077 development program in sleep disorders. Mr. McFarlane continued, “We are encouraged by the positive data from our Phase 2 study of KP1077 in patients with idiopathic hypersomnia. KP1077 has been well tolerated while demonstrating early signs of differentiated clinical benefits. These data will help inform our registrational study, which we will discuss with FDA at an end of phase 2 meeting.” Recent Business and Corporate Highlights: Completion of the Acquisition of Acer Therapeutics, Inc. (Acer): On November 20, 2023, the Company announced the completion of its acquisition of Acer. The acquisition brought multiple complementary rare disease assets, increased Zevra’s revenue potential, and bolstered Zevra’s commercial and development capabilities. OLPRUVA, an FDA-approved treatment indicated for certain urea cycle disorders (UCDs): To support the commercial launch, the Company accelerated the build-out of a focused and effective customer-facing team with decades of experience in rare diseases. The team includes Rare Disease Sales Specialists, Marketers, Patient Services and Market Access professionals, as well as Medical Science Liaisons and Patient Advocates who are in the field engaging with key customers, with our efforts largely focused on approximately 40 centers of excellence across the United States. To raise awareness of the benefits of OLPRUVA, the Company has established Quick Start, which is a 30-day free trial to allow patients and physicians to gain experience with the treatment. Zevra continues to partner with the patient community and UCD treatment centers of excellence to drive brand recognition, while also working with payors to ensure access to OLPRUVA. The Company has seen a meaningful increase in reimbursement coverage since the acquisition, and currently there is more than 70% overall coverage for OLPRUVA with commercial and government payors. The Company expects that OLPRUVA’s commercial operations and capabilities will provide scale and cost synergies to support and accelerate the launch and commercialization of arimoclomol, if approved. Arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC), an ultra-rare, genetic, progressive and fatal neurological disease: During Q4 2023, the Company submitted a comprehensive data set to the U.S. Food and Drug Administration (FDA) supporting its resubmission of the New Drug Application (NDA) for arimoclomol. On March 4, 2024, the Company announced that the FDA had extended the review period for the NDA, resulting in a revised Prescription Drug User Fee Act (PDUFA) date of September 21, 2024. The FDA re-affirmed its intent to present the resubmission for discussion at an advisory committee meeting to be scheduled. If approved, arimoclomol will be a first-in-class, orally delivered treatment for NPC, and the Company will be eligible to receive a Priority Review Voucher. Zevra is preparing for the commercial launch of arimoclomol in the U.S., if approved, and will leverage the commercial infrastructure that is in place for OLPRUVA. The Company plans to publish real-world evidence data from its Expanded Access Program (EAP) and additional data from clinical studies regarding safety and efficacy, to inform physician treatment decision-making and support market access. The Company intends to complete the regulatory filing for arimoclomol in the U.S., and then continue its evaluation of optimal regulatory pathways to approval in the E.U. and other parts of the world. KP1077 (serdexmethylphenidate, or SDX), an investigational therapeutic candidate both for the treatment of idiopathic hypersomnia (IH), a rare sleep disorder characterized by excessive daytime sleepiness, and for the treatment of narcolepsy: On March 26, 2024, the Company reported positive topline data from its placebo-controlled, double-blind, proof-of-concept Phase 2 study of KP1077 in patients with IH. KP1077 was well-tolerated at all dose levels evaluated in the trial, including the highest dose of 320 mg daily, regardless of dosing regimen (once or twice daily), supporting the study’s primary endpoint of safety and tolerability. KP1077 produced clinically meaningful improvement in excessive daytime sleepiness, as assessed by change from baseline in the Epworth Sleepiness Scale. This improvement was maintained during both the five-week open-label titration period and throughout the 2-week double-blind withdrawal period for both dosing regimens. Patients administered KP1077 showed benefits in change from baseline for the IH Severity Scale, Sleep Inertia Visual Analog Scale and Brain Fog severity Scale at the end of the open-label dose titration, and at the end of the double-blind withdrawal period. The study successfully fulfilled the objectives of providing key information for the design of a potentially pivotal efficacy trial, and the results of the secondary efficacy endpoints are supportive of initiating a Phase 3 trial of KP1077. The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design. The Company will present new data from a Phase 1 study completed under the narcolepsy IND, and the final results from its Phase 2 study of KP1077 in IH at the upcoming SLEEP 2024 conference. Overview of Q4 2023 and FY 2023 Financial Results: Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million. The components of revenue during the current quarter include ongoing royalties from AZSTARYS®, reimbursements from the French EAP for arimoclomol, and some initial sales of OLPRUVA. Research and development (R&D) expenses were $11.4 million for Q4 2023, compared to $6.5 million in Q4 2022. The increase in R&D expenses was primarily driven by the ongoing Phase 2 clinical study in KP1077, and ongoing work supporting to support the arimoclomol NDA which was resubmitted to the FDA in December 2023. General and administrative (G&A) expenses were $14.7 million for Q4 2023, compared to $4.7 million in Q4 2022. The period-over-period increase was primarily related to an increase in personnel costs and professional fees associated with our commercial and business development activities. Net loss for Q4 2023 was ($19.6) million, or ($0.51) per basic and diluted share, compared to a net loss of ($3.0) million, or ($0.09) per basic and diluted share for the same period in 2022. Net revenue for FY 2023 was $27.5 million compared to prior year net revenue of $10.2 million. The period-over-period increase was primarily attributed to an increase of $18.5 in royalties and milestones received under the AZSTARYS License Agreement, which includes $15.0 million in one-time net sales milestone payments earned during FY 2023, an increase in sales of arimoclomol of $3.3 million, partially offset by a decrease in consulting revenue of $4.5 million. R&D expenses were $39.8 million for FY 2023, compared to $19.8 million for FY 2022. The increase in R&D expenses was primarily driven by the ongoing KP1077 Phase 2 clinical study in IH, along with work to prepare the arimoclomol NDA for resubmission. G&A expenses were $34.3 million for FY 2023, compared to $15.0 million in FY 2022. The period-over-period increase was primarily related to an increase in personnel costs and professional fees associated with our commercial and business development activities. Net loss for FY 2023 was ($46.0) million, or ($1.30) per basic and diluted share, which includes the non-cash impact of the change in fair value adjustment for the warrant liability of ($1.4) million, or ($0.04) per basic and diluted share. Net loss for FY 2022 was ($26.8) million, or ($0.78) per basic and diluted share. As of December 31, 2023, total cash, cash equivalents, and cash investments were $67.7 million, a decrease of $15.7 million compared to $83.4 million as of September 30, 2023. The decrease was driven, in part, by increased third-party R&D costs related to the KP1077 clinical development program, the arimoclomol program, and increased G&A expenses during the period as the Company invested in its commercial infrastructure. Based on our current operating forecast and available resources, our cash runway is expected to extend into 2026. Our cash runway forecast includes revenue from the expected sales of OLPRUVA, ongoing reimbursements from the French EAP for arimoclomol, and investments into the incremental commercial activities needed to support the launch of arimoclomol, if approved, and completion of the KP1077 development program for IH. Our cash runway forecast does not include any commercial revenue from arimoclomol which could follow a potential FDA approval, or the potential sale of the Priority Review Voucher which would be received upon approval. On November 17, 2023, Zevra completed the acquisition of Acer. Pursuant to the Merger Agreement, Acer continues as a wholly owned subsidiary of Zevra. The Merger included the acquisition of OLPRUVA® (sodium phenylbutyrate) for oral suspension, which was approved by the FDA on December 27, 2022, for the treatment of urea cycle disorders. Acer also has a pipeline of investigational product candidates, including celiprolol for the treatment of vascular Ehlers-Danlos syndrome, patients with a confirmed type III collagen (COL3A1) mutation. At the effective time of the Merger (the "Effective Time"), each share of common stock of Acer, par value $0.0001 per share, issued and outstanding immediately prior to the Effective Time (excluding cancelled shares and any shares held by holders who have exercised their appraisal rights) were converted into the right to receive (i) 0.1210 fully paid and non-assessable shares of common stock of Zevra, par value $0.0001 per share, and (ii) one non-transferable contingent value right (“CVR”) issued by Zevra, which represents the right to receive one or more contingent payments up to an additional $76.0 million upon the achievement, if any, of certain commercial and regulatory milestones for Acer’s OLPRUVA and celiprolol products within specified time periods. Certain additional cash payments are also possible pursuant to the CVRs with respect to milestones involving Acer’s early-stage program ACER-2820 (emetine). As of December 31, 2023, total shares of common stock outstanding were 41,534,668, and fully diluted common shares outstanding were 58,230,596, which included 5,603,729 shares issuable upon exercise of warrants. On March 25, 2024, the Audit Committee (the “Audit Committee”) of the Company’s Board of Directors, after discussion with senior management and the Company’s independent registered public accountants, concluded that the Company’s previously issued audited consolidated financial statements as of and for the fiscal years ended December 31, 2022 and December 31, 2021, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, (collectively, the “Prior Financial Statements”) should no longer be relied upon. In connection with the preparation of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Form 10-K”), the Audit Committee concluded that, in prior years it had not appropriately accounted for certain common stock warrants as liabilities. These errors led to understatements of derivative and warrant liability and additional paid-in capital and fluctuations in fair value adjustment related to derivative and warrant liability during the impacted periods. In addition, in connection with the restatements, the Company has concluded that the previously disclosed errors led to misstatements of fair value adjustment related to derivative and warrant liability, derivative and warrant liability, additional paid-in capital, and retained earnings/(accumulated deficit) that were previously disclosed in the unaudited condensed consolidated balance sheets and statements of operations included in the Company’s Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2022, June 30, 2022, September 30, 2022, March 31, 2023, June 30, 2023 and September 30, 2023 (collectively, the “Prior Interim Financial Statements”). On March 25, 2024, the Audit Committee, after discussion with senior management and the Company’s independent registered public accountants, concluded that the Prior Interim Financial Statements should no longer be relied upon. The errors and corrective adjustments identified by the Company are non-cash in nature; and they do not impact results of operations or key metrics used by the Company in managing operations, such as revenue, operating expenses, and loss from operations. Conference Call Information Zevra will host a conference call and live audio webcast today at 4:30 p.m. ET, to discuss its corporate and financial results for Q4 and FY 2023. The audio webcast will be accessible via the Investor Relations section of the Company’s website, . An archive of the audio webcast will be available for 90 days beginning at approximately 5:30 p.m. ET, on March 28, 2024. Additionally, interested participants and investors may access the conference call by dialing either: (800) 245-3047 (U.S.) +1 (203) 518- 9765 (International) Conference ID: ZVRAQ423 About Urea Cycle Disorders UCDs are a group of rare, genetic disorders that can cause harmful ammonia to build up in the blood, potentially resulting in brain damage and neurocognitive impairments if ammonia levels are not controlled.i Any increase in ammonia over time is serious. Therefore, it is important to adhere to any dietary protein restrictions and have alternative medication options to help control ammonia levels. About OLPRUVA® OLPRUVA (sodium phenylbutyrate) was approved for the treatment of certain UCDs in December 2022 and has recently been marketed under the brand name, OLPRUVA®. OLPRUVA (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). Please see Important Safety Information and full Prescribing Information, including Patient Information. Important Safety Information Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Tell your doctor about all the medicines you or your child take, especially if you or your child take corticosteroids, valproic acid, haloperidol, and/or probenecid. OLPRUVA can cause serious side effects, including: 1) nervous system problems (neurotoxicity). Symptoms include sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA is right for you. The most common side effects of OLPRUVA include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. About Niemann-Pick Disease Type C (NPC) Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder characterized by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various tissue areas, including brain tissue. The disease is caused by mutations in the NPC1 or NPC2 genes, which are responsible for making lysosomal proteins. Both children and adults can be affected by NPC with varying clinical presentations. Those living with NPC lose independence due to physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills. Disease progression is irreversible and can be fatal within months or take years to be diagnosed and advance in severity. About Arimoclomol Arimoclomol, Zevra’s orally delivered, first-in-class investigational product candidate for the treatment of NPC, has been granted Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, and Rare Pediatric Disease designation by the FDA, and Orphan Medicinal Product designation for the treatment of NPC by the European Medicines Agency (EMA). The FDA has accepted the resubmission of the NDA for arimoclomol and has set a user fee goal date (PDUFA date) of September 21, 2024. About Idiopathic Hypersomnia (IH) Idiopathic hypersomnia (IH) is a rare sleep disorder characterized by excessive daytime sleepiness (EDS). Patients with IH experience daytime lapses into sleep, or an irrepressible need to sleep that persists even with adequate or prolonged nighttime sleep. Additionally, those with IH have extreme difficulty waking, otherwise known as sleep inertia, severe brain fog, and often fall asleep unintentionally or at inappropriate times. These symptoms of IH often lead to further, even more debilitating problems such as memory lapses, difficulty maintaining focus, and depression. It is estimated, based on claims data, that approximately 37,000 patients in the United States are currently diagnosed with IH, although the total patient population may be much larger due to some patients who have not yet been diagnosed, have been misdiagnosed, or are not currently seeking treatment. About KP1077 KP1077 (serdexmethylphenidate or SDX) is Zevra’s proprietary prodrug of d-methylphenidate (d-MPH) and its sole active pharmaceutical ingredient (API). KP1077 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IH, and the U.S. Drug Enforcement Agency (DEA) has classified SDX, the sole API in KP1077, as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance. About Zevra Therapeutics Zevra Therapeutics is a rare disease company combining science, data, and patient needs to create transformational therapies for diseases with limited or no treatment options. Our mission is to bring life-changing therapeutics to people living with rare diseases. With unique, data-driven development and commercialization strategies, the Company is overcoming complex drug development challenges to make new therapies available to the rare disease community. Expanded access programs are made available by Zevra Therapeutics and its affiliates and are subject to the Company's Expanded Access Program (EAP) policy as published on its website at . Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician's discretion. For more information, please visit or follow us on X (formerly Twitter) and LinkedIn. Cautionary Note Concerning Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the promise and potential impact of our preclinical or clinical trial data, the initiation, timing and results of any clinical trials or readouts, the content, information used for, timing or results of any NDA submissions or resubmissions for arimoclomol or any other product candidates for any specific disease indication or at any dosage, the potential launch or commercialization of any of product candidates or products, the Company’s estimated extent of and impacts of the restatements and the timing of the filing of the 2023 Form 10-K, the sufficiency of our cash, cash equivalents and investments to fund our operating activities for any specific period of time, our plans to build out commercial teams for products or product candidates, and our strategic and product development objectives, including with respect to becoming a leading, commercially focused rare disease company. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated in Zevra’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release. __________________________ i Ah Mew N, et al. Urea cycle disorders overview [updated June 22, 2017]. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews® [Internet]. University of Washington; 1993-2022. Accessed March 20, 2022. ZEVRA THERAPEUTICS, INC. STATEMENTS OF OPERATIONS (In thousands, except share and per share amounts) (Unaudited) Year Ended December 31, 2023 2022 (As Restated) Revenue, net $ 27,461 $ 10,161 Operating expenses: Cost of revenue 2,945 222 Research and development 39,806 19,803 Selling, general and administrative 34,314 15,038 Acquired in-process research and development - 17,663 Total operating expenses 77,065 52,726 Loss from operations (49,604 ) (42,565 ) Other (expense) income: Interest expense (1,501 ) (335 ) Fair value adjustment related to derivative and warrant liability (98 ) 15,159 Fair value adjustment related to investments 613 (577 ) Interest and other income, net 4,541 1,513 Total other income 3,555 15,760 Loss before income taxes (46,049 ) (26,805 ) Income tax (expense) benefit - 33 Net loss $ (46,049 ) $ (26,772 ) Basic and diluted net loss per share of common stock: Net loss $ (1.30 ) $ (0.78 ) Weighted average number of shares of common stock outstanding: Basic and diluted 35,452,460 34,488,800 ZEVRA THERAPEUTICS, INC. BALANCE SHEETS (In thousands, except share and par value amounts) (Unaudited) December 31, 2023 2022 (As Restated) Assets Current assets: Cash and cash equivalents $ 43,049 $ 65,466 Securities at fair value 24,688 16,900 Short-term investments - other - 481 Accounts and other receivables 17,377 8,299 Prepaid expenses and other current assets 1,824 1,688 Total current assets 86,938 92,834 Inventories 9,841 671 Property and equipment, net 736 794 Operating lease right-of-use assets 790 988 Goodwill 4,701 - Long-term investments - other - 20,000 Intangible assets, net 69,227 - Other long-term assets 94 53 Total assets $ 172,327 $ 115,340 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $ 28,403 $ 6,169 Line of credit payable 37,700 12,800 Current portion of operating lease liabilities 543 480 Current portion of discount and rebate liabilities 4,550 4,655 Other current liabilities 2,524 719 Total current liabilities 73,720 24,823 Secured promissory note 5,066 - Derivative and warrant liability 16,100 10,202 Operating lease liabilities, less current portion 456 843 Discount and rebate liabilities, less current portion 7,663 4,327 Other long-term liabilities 7,458 25 Total liabilities 110,463 40,220 Commitments and contingencies Stockholders' equity: Preferred stock: Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of December 31, 2023 or December 31, 2022 - - Common stock, $0.0001 par value, 250,000,000 shares authorized, 43,110,360 shares issued and 41,534,668 shares outstanding as of December 31, 2023; 35,450,257 shares issued and 34,540,304 shares outstanding as of December 31, 2022 4 3 Additional paid-in capital 472,664 436,269 Treasury stock, at cost (10,983 ) (7,536 ) Accumulated deficit (399,778 ) (353,729 ) Accumulated other comprehensive income (43 ) 113 Total stockholders' equity 61,864 75,120 Total liabilities and stockholders' equity $ 172,327 $ 115,340 Zevra Contact Nichol Ochsner +1 (732) 754-2545 nochsner@zevra.com Russo Partners Contacts Adanna G. Alexander, Ph.D. +1 (646) 942-5603 adanna.alexander@russopartnersllc.com

DUBLIN, March 13, 2024 /PRNewswire/ -- The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to ResearchAndMarkets.com's offering. Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments. This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024. The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010. Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal. Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates. Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate. In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector. Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits: Understand royalty rate trends since 2010 Analysis of the structure of royalty clauses with real life case studies Browse collaboration and licensing deals which reveal a royalty rate Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing actual contract agreements allows assessment of the following: What are the precise royalty rates granted? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction 1.1. What are royalties? 1.2. History of royalty rates 1.3. Royalties in pharmaceuticals and biotechnology 1.4. Royalties versus revenue share 1.5. Overview of the report Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates 2.1. Trends in royalty rates 2010 - 2024 2.2. How do revenue shares figure? 2.3. A review of recent literature 2.4. Royalty rates in the future Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals 3.1. Partnering agreement structure 3.2. Structure of a typical royalty clause 3.3. Example royalty clauses 3.3.1. Case study 1 3.3.2. Case study 2 3.3.3. Case study 3 3.3.4. Case study 4 Chapter 4 - Companies actively disclosing royalty rates 4.1. Most active companies in disclosing royalty rates Chapter 5 - Royalty rate contract directory Explore royalty rates within the deal contract document to gain greater insight Deal directory Deal Directory - Royalty rates in deals - by company A-Z Deal Directory - Royalty rates in deals - by therapy area Deal Directory - Royalty rates in deals - by stage of development at signing Deal Directory - Royalty rates in deals - by technology type Royalty rate references Example royalty rate deal contract document List of Figures Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024 Figure 2: Components of the partnering deal structure Figure 3: Components of the partnering royalty clause Figure 4: Most active companies disclosing royalty rate 2010 - 2024 Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies Companies Mentioned 2seventy bio 3a-diagnostics 3D Medicines 4SC 23andMe Abbott Laboratories Abbvie Abeona Therapeutics Ablynx Abraxis BioScience ABVC BioPharma ACADIA Pharmaceuticals Acceleron Pharma Acelrx Pharmaceuticals Acer Therapeutics Acerus Acrotech Biopharma Actavis (acquired by Watson) Active Biomaterials Acura Pharmaceuticals Adamis Pharmaceuticals Adaptimmune ADC Therapeutics Adeona Pharmaceuticals Adial Pharmaceuticals Aditx Therapeutics Adlai Nortye Aduro BioTech Advanced Dosage Forms Advanz Pharma Advaxis Advirna Aegerion Pharmaceutical Aeglea BioTherapeutics Aerie Pharmaceuticals AEterna Zentaris Aexon Labs Affimed Therapeutics Afritex Medical Products AFT Pharmaceuticals Agenus Bio Agios Pharmaceuticals Aguettant AiBtl BioPharma AIT Therapeutics Akcea Therapeutics Akebia Therapeutics Albert Einstein College of Medicine Alchemia Alder Biopharmaceuticals Alector Alexion Pharmaceuticals Alexza Pharmaceuticals Alfasigma Alfa Wassermann Allergan Allergan (name changed from Actavis) Almirall Alnylam Pharmaceuticals Alora Pharmaceuticals Alpha Biopharma Alternavida Altman Enterprises AltrazealTrading Altum Pharmaceuticals Alvogen Amarantus BioSciences American Type Culture Collection (ATCC) Amgen Amherst Pharmaceuticals Amorfix Life Sciences Ampio Pharmaceuticals Amryt Pharma Amylin Pharmaceuticals Amyris AnaBios AnaptysBio AnGes MG Angion Biomedica AnnaMed Antares Pharma Antibe Therapeutics Antigen Express Applied Therapeutics Apricus Biosciences Aquestive Therapeutics Aradigm Aratana Therapeutics Arcellx Arch Pharmalabs Arctic Vision Arcturus Therapeutics Arcus Biosciences Ardelyx Arena Pharmaceuticals Arrowhead Pharmaceuticals Artiva Biotherapeutics Arvinas Ascendis Pharma Ascentage Pharma Ashvattha Therapeutics Assembly Biosciences Astellas Pharma Astellas Pharma Europe Asterias Biotherapeutics AstraZeneca Athenex Atossa Therapeutics Atreca Audeo Oncology Augmenta Aurigene Discovery Technologies Aurinia Pharmaceuticals Authentic Brands Group AVEO Oncology Avita Therapeutics Avivagen Axovant Gene Therapies Axsome Therapeutics Aytu BioPharma Azaya Therapeutics Azure Biotech Baker Brothers Investments BAKX Therapeutics Baliopharm BASF Baxter International Bayer Healthcare Bayer Innovation Baylor Research Institute Beam Therapeutics BeiGene Beijing Defengrei Biotechnology Belgian Volition Bellerophon Therapeutics Benitec Biopharma Besins Healthcare Beth Israel Deaconess Medical Center BetterLife Pharma Bharat Biotech BIND Biosciences BioCorRx BioCryst Pharmaceuticals Bioeq IP Biogen BioGene Technology Biohaven Pharmaceuticals BioInvent BiolineRX BioMarin Pharmaceutical BioNovion BioNTech BioNxt Solutions Biopharmex BiopharmX BioPorto Bioprocess Capital Ventures BioProspect Biostem US Biotech Investment Biotechnology Value Fund BioTime Acquisition Bioton Biovail BioZone Laboratories BioZone Pharmaceuticals Blackstone Bluebird Bio Blueprint Medicines BMV Medica Boehringer Ingelheim Bone Therapeutics Braeburn Pharmaceuticals BrainStorm Cell Therapeutics Breathtec BioMedical Brickell Biotech BridgeBio Pharma Bridge Biotherapeutics Bristol-Myers Squibb Caleco Pharma Calico Can-Fite BioPharma Cancer Prevention Pharmaceuticals Cannassure Therapeutics CanniMed Therapeutics Cann Pharmaceutical Australia Canntab Therapeutics Cannus Partners Cantex Pharmaceuticals Cara Therapeutics Cardigant Medical Cardium Therapeutics CareFusion Carna BioSciences Cary Pharmaceuticals CASI Pharmaceuticals Castle Creek Biosciences Catalent CB2 Therapeutics Celdara Medical Celgene Cell Cure Neurosciences Cellvera Cel Sci Celyad Cereal Ingredients Cerebain Biotech Cerus CGA 369 cGreen Chi-Med Chiesi Farmaceutici Chimerix Chong Kun Dang Chongqing Jingdong Pharmaceutical Cimtech Cipher Pharmaceuticals Cipla Circassia Clal Biotech Clalit Health Services Clearmind Medicine Clearside Biomedical Clemson University Cleveland BioLabs Clinigen CMIC CNS Pharmaceuticals Cocrystal Pharma Coeptis Pharmaceuticals CohBar Cohen-McNiece Foundation Coherus Biosciences Colby Pharmaceuticals Collegium Pharmaceuticals Columbia Laboratories Columbia University Common Sense Conatus Pharmaceuticals Concile Consilient Health ContraFect Coronado Biosciences Cosmofix Cosmo Pharmaceuticals Coya Therapeutics CRISPR Therapeutics Crossject Crucell CSL CTI BioPharma CTT Pharmaceutical Cullinan Oncology Cumberland Pharmaceuticals Cures Within Reach CureTech Curis Currax Pharmaceuticals CURx Pharmaceuticals Cutanea Life Sciences Cybin CymaBay Therapeutics Cypress Bioscience Cytodyn Cytokinetics Cytori Therapeutics Daewoong Pharmaceutical Daiichi Sankyo Dana-Farber Cancer Institute Dance Biopharm DAS Therapeutics Defiante Farmaceutica Denali Therapeutics DepoMed Derma Sciences Dermavant Sciences Dermin Dianomi Therapeutics Dicerna Pharmaceuticals DNA Biomedical Solutions Dr. Falk Pharma Dr. Reddy's Laboratories Dragonfly Therapeutics DRI Capital Drugs for Neglected Diseases Initiative DS Healthcare Duke University Dyax Eagle Pharmaceuticals Eagle Pharmaceuticals (US) Easton Pharmaceuticals Echo Therapeutics Ecology Coatings Eczacibasi Pharmaceuticals Eddingpharm Egalet Eisai Elencee Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emory University Enalare Therapeutics Endocyte Endo Pharmaceuticals EnGeneIC Enochian Biosciences Entera Bio Entest BioMedical EnWave Epizyme Epocal Esperion Therapeutics Eternity Healthcare Eton Pharmaceuticals Eureka Genomics EUSA Pharma Evolva Ewopharma Exact Sciences Exelixis ExScientia Eyevance Fairview Health System FasTrack Pharmaceuticals Ferozsons Laboratories Ferring Pharmaceuticals Fibrocell Science Foghorn Therapeutics Forest Laboratories Fosun Pharmaceutical Fox Chase Chemical Diversity Center Fresenius Kabi Pharmaceuticals FSD Pharma Fusion Pharmaceuticals FusionVax Galapagos Galmed Pharmaceuticals GE Healthcare Genentech Generex Biotechnology Genevant Sciences Genexine Genfit Genmab Gentium Genzyme Geron Gilead Sciences Glaukos Glenmark Generics Inc USA Glenmark Pharmaceuticals Goldfinch Bio Government of Israel GPCR Therapeutics Gravocore Grifols GSK GT Biopharma Hai Kang Life Hail First Pharma Hainan Sihuan Pharmaceutical Halo Labs Halozyme Therapeutics Hansen Medical Health Canada Healthcare Royalty Partners Health Discovery Heartseed Heat Biologics Hefei Life Science Hefei Tianhui Incubation of Technologies HekaBio Helsinn Therapeutics HemoCleanse Hemogenyx HemPup Henlius Biotech Hetero Labs HIBM Research Group Hikma Pharmaceuticals Hoffmann La Roche Hollister Biosciences Hookipa Pharma Horizon Pharma Inc Huadong Medicine HyperGenomics I-mab Icahn School of Medicine at Mount Sinai Ice + Jam Iconovo IDC-GP Pharm IDEAYA Biosciences Idera Pharmaceuticals Idorsia Idun Pharmaceuticals IGM Biosciences iMetabolic Biopharma Immugenyx Immunic ImmunityBio Immunomedics Immunomic Therapeutics Immunovative Therapies ImmVira Impax Laboratories Imprimis Pharmaceuticals In4Derm iNAP Incannex Healthcare Incuron Incyte Indiana University Infinity Pharmaceuticals InflaRx Inhibitor Therapeutics Innate Pharma Innocoll Innovate Biopharmaceuticals Innovation Pharmaceuticals Innovent Biologics Innovet Innovus Pharmaceuticals INO Therapeutics Inspiration Biopharmaceuticals Instrumentation Laboratory IntelGenx Intellia Therapeutics IntelliCell BioSciences Intellikine Internet Marketing Consortium Intrexon Intuitive Surgical Invekra Inverness Medical Innovations Ionis Pharmaceuticals Ipsen Iroko Pharmaceuticals Ironwood Pharmaceuticals Israeli National Authority for Technological Innovation Itrom Pharmaceutical Group Ivantis Jaguar Health Janssen Biotech Janssen Pharmaceuticals Jazz Pharmaceuticals JFC Technologies Jiangsu Alphamab Jiangsu Lianhuan Pharmaceuticals Jiangsu NHWA Pharmaceutical Ji Xing Pharmaceuticals John Morley Foods Joincare Pharmaceutical Journey Medical Jubilant Life Sciences Jumpcan Pharmaceutical Juniper Pharmaceuticals Junshi Biosciences Jupiter Wellness Juventas Therapeutics K2M Kadmon Pharmaceuticals Kaken Pharmaceutical Kalbe Genexine Biologics KaloBios Pharmaceuticals Karveer Meditech KemPharm Kensey Nash Kieran Murphy Kinetic Concepts Kiniksa Pharmaceuticals Kintor Kiromic Biopharma Kite Pharma Kitov Pharma Klaria Klinge Biopharma Knighton Foods Knight Therapeutics Kodiak Sciences Kowa Kraig Biocraft Laboratories KVK-Tech Kwang Dong Pharmaceutical Kymera Therapeutics Kyowa Hakko Kirin Kyverna Therapeutics L1 Systems Laboratories Acbel Lantheus Holding Launch Therapeutics Lee Moffitt Cancer Center Legend Biotech LegoChem Biosciences Level Brands LFB Biotechnologies Lifestyle Delivery Systems Ligand Pharmaceuticals Lineage Cell Therapeutics Link Health Lipidor Lipocine Lixte Biotechnology Lorna Linda University Lotus Pharmaceuticals Loxo Oncology Lubrizol Lumenis Lundbeck Lung Therapeutics MabCure Macrogenics Magenta Therapeutics MainPointe Mallinckrodt Pharmaceuticals Marvanal Marv Enterprises Massachusetts General Hospital Matrix Biomed Mayne Pharma McComb Foundation McEwen Centre for Regenerative Medicine Meda Medica Medica Avante Medical Technologies Innovation Asia Medice Arzneimittel Putter Medicines Patent Pool Foundation Medicox MediGene Medigus MedImmune Medison Pharma Medivation Medivir Medovex MEI Pharma Melmed Memory Dx Mercer University Merck and Co Merck KGaA Merck Serono Merus Methodist Hospital Houston Micromet Mikah Pharma Millennium Mimi's Rock Mindset Pharma Ministry of Health Labor and Welfare MiNK Therapeutics Miraculins Miralogx Mira Pharmaceuticals Miromatrix Medical Mitsubishi Tanabe Pharma Moderna Modis Therapeutics Moleculin Biotech Mologen Momenta Pharmaceuticals Monash University Monopar Therapeutics Morgan Stanley MorphoSys Mount Sinai Health System MultiCell Immunotherapeutics Munich Leukemia Laboratory Mylan Laboratories Mylan Pharmaceuticals Myovant Sciences NanoVibronix NanoViricides NantCell NantKwest Nantong Jinghua Pharmaceutical NantWorks Napo Pharmaceuticals Natac Biotech Natco Pharmaceuticals National Green Biomed Nektar Therapeutics Neogenomics Neotope Nephrogenex Nephros Nestle Health Science Neuraxpharm Neurocrine Biosciences NeuroRx NeuroSigma NeuroVive Pharmaceutical NeuroVive Pharmaceutical Asia NewLeaf Brands Newsoara Biopharma New York University NexMed NextCure Nextleaf Solutions Nexvet NGM Biopharmaceuticals Nicox Nkarta Therapeutics NLS Pharmaceutics Nordic Bioscience Norgine NorthStar Medical Radioisotopes Notable Labs Novadaq Technologies NovaDel Pharma Novan Novan Therapeutics Novartis Novartis Vaccines and Diagnostics Novocure Novo Nordisk Novus Biologicals NRx Pharmaceuticals Nucorion Numab Nunzi Pharmaceutical Nurix Therapeutics Nutech Medical NutraOrigin NXTGEN Nymox Pharmaceutical Oberland Capital Ocugen Oculus Innovative Sciences Ocumension Therapeutics Omeros Oncologie Oncolytics Biotech OncoMed Pharmaceuticals Onconova Therapeutics Onegevity One Way Liver Genomics (OWL) ONK Therapeutics Ono Pharmaceutical Onxeo Onyx Pharmaceuticals Opexa Therapeutics Opthea OptiBiotix OptiNose Oragenics Oramed Pharmaceuticals Orexigen Therapeutics Organovo Orgenesis Orion Orox Pharmaceuticals OrthoCyte Otsuka OvaMed Ovid Therapeutics Oxford BioMedica Oxis Biotech Oxygen Biotherapeutics OxySure Systems Oyster Point Pharma Pan-Provincial Vaccine Enterprise Parnell Pharmaceuticals Par Pharmaceutical PDL BioPharma PDS Biotechnology Penwest Pharmaceuticals Pernix Therapeutics Perugia University Pfenex Pfizer Pharmacyclics PharmaCyte Biotech PharmaMar PharmaNova Pharmastrip Philogen Phosphagenics Photocure ASA Phusion Laboratoies Phyto Nutricare Pipex Pharmaceuticals Plandai Biotechnology Pluristem Therapeutics POINT Biopharma Portola Pharmaceuticals Poseida Therapeutics Pozen PreMD Premier Biomedical Professional Compounding Centers of America Progenics Pharmaceuticals Prometic Life Sciences ProQR Therapeutics Prosidion Protagonist Therapeutics Protalix BioTherapeutics Proteonomix Prothena ProtoKinetix Pulmatrix Puma Biotechnology QED Therapeutics QRxPharma Quick Med Technologies Quigley Corporation Quoin Pharmaceuticals Rayner Surgical Reata Pharmaceuticals Recordati Recro Pharma RedHill Biopharma Reedy Creek Investments RegenaStem Regeneron Pharmaceuticals Regenxbio Regnum Relay Therapeutics Relief Therapeutics Relmada Therapeutics RenalytixAI ReNeuron Repare Therapeutics Replicel Life Sciences Repligen Reprise Biomedical Resarci Therapeutics Retrophin rEVO Biologics Revolution Medicines Rigel Pharmaceuticals RNL Bio Roche Rockefeller University Roivant Sciences Royalty Pharma RST Biomedikal Sanayi Ruthigen RXi Pharmaceuticals S2 Therapeutics SACCO Sagard Healthcare Royalty Partners Sage Therapeutics Salix Pharmaceuticals Sam Amer Sanara MedTech Sandoz Sanofi Sanofi-Aventis Sanofi-Pasteur Sanpellegrino Cosmetics Santarus Santen Pharmaceutical Sanuwave Health SA Pathology Sapientia Pharmaceuticals Sarepta Therapeutics Schrodinger Scopus BioPharma Seagen Seattle Genetics Seelos Therapeutics Sekris Biomedical Senetek Senior Paradise Sensory Cloud Seqirus Seres Therapeutics Sermonix Pharmaceutical Sesen Bio SevenScore Pharmaceuticals Shanghai Pharmaceuticals Holdings Sheba Medical Center Shenzhen BioScien Pharmaceuticals Shield Therapeutics Shionogi Shire Pharmaceuticals Shore Therapeutics Siemens Healthcare Diagnostics Sigma-Tau Sinclair Pharmaceuticals Sinobiopharma Sinopharm Sio Gene Therapies Skinvera Skyline Diagnostics Solarvest BioEnergy Soliance Soligenix Sonoma BioTherapeutics Sorrento Therapeutics Spectranetics Spencer Pharmaceutical Spinal USA St. Jude Children's Research Hospital STADA Arzneimittel Staidson (Beijing) BioPharmaceuticals Stanford University Stealth BioTherapeutics Stellar Biotechnologies St Jude Medical Stoke Therapeutics Strongbridge Biopharma Sucampo AG SUDA Pharmaceuticals Sumitomo Dainippon Pharma Sunesis Pharmaceuticals Sunovion Pharmaceuticals Sun Pharmaceutical SuperNova Diagnostics Sutro Biopharma Swedish Orphan Biovitrum SymBio Pharmaceuticals Symbollon Syndax Pharmaceuticals Synergy Strips Syntopix Tactical Relief Taiba TaiGen Biotechnology Taiho Takeda Pharmaceutical Talaris Therapeutics Tango Therapeutics Target Group Tauriga Sciences TB Alliance TearLab Technion Research and Development Foundation Teijin Telomir Pharmaceuticals Tesaro Tetra Bio-Pharma TetraLogic Pharmaceuticals Teva Pharmaceutical Industries Texas A&M University Texas Heart Institute TFF Pharmaceuticals TG Therapeutics Therakine TherapeuticsMD Theravance Theravance Biopharma The Regents of the University of California Thorne Research Threshold Pharmaceuticals TiGenix Tilray Titterington Veterinary Services Tiziana Life Sciences Tocagen TONIX Pharmaceuticals Torii Pharmaceutical TRACON Pharmaceuticals Tramorgan Transgene Travere Therapeutics Trellis Bioscience Trevena Trimedyne Trimeris TrovaGene TTFactor Tufts University Turnstone Biologics Tyme Technologies Ultragenyx Pharmaceuticals Uluru Unigene Laboratories UniQure Universal Cells University College Dublin University Health Network University of Alberta University of California University of Central Florida Research Foundation University of Colorado University of Florida Research Foundation University of Geneva University of Louisville University of Missouri University of Notre of Dame University of Pennsylvania University of Texas University of Virginia University of Western Sydney University of Zurich UOP Uppsalagruppen Medical Upstream Peripheral Technologies UroGen Pharma Valeant Pharmaceuticals ValiPharma Valneva Valor Biotherapeutics Vanderbilt University Vasomune Therapeutics Vaxent VBL Therapeutics Veloxis Pharmaceuticals Veracyte Verenium Verity Pharmaceuticals VeroScience Vertex Pharmaceuticals Vida Concepts Vifor Pharma ViiV Healthcare Virbac Viropharma VistaGen Therapeutics Vividion Therapeutics Vivus VolitionRX Voronoi Voyager Therapeutics Vyera Pharmaceuticals VYNE Therapeutics Vyrix Pharmaceuticals Watson Pharmaceuticals WAVE Life Sciences Wigen Biomedicine Wisconsin Alumni Research Foundation World Class Extractions WPD Pharmaceuticals WUGEN Xbrane Bioscience Xencor Xlife Sciences XPhyto Therapeutics XTL Biopharmaceuticals Xynomic Pharmaceuticals Yale University Yeda Research and Development Company Yeugnam University Yissum Research Development ZAI Laboratory Zalicus Zenitech Zenith Epigenetics Ziopharm Oncology Zogenix ZS Pharma Zymeworks For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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DUBLIN--( BUSINESS WIRE )--The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to ResearchAndMarkets.com's offering. Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments. This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024. The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010. Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal. Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates. Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate. In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector. Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits: Understand royalty rate trends since 2010 Analysis of the structure of royalty clauses with real life case studies Browse collaboration and licensing deals which reveal a royalty rate Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing actual contract agreements allows assessment of the following: What are the precise royalty rates granted? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction 1.1. What are royalties? 1.2. History of royalty rates 1.3. Royalties in pharmaceuticals and biotechnology 1.4. Royalties versus revenue share 1.5. Overview of the report Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates 2.1. Trends in royalty rates 2010 - 2024 2.2. How do revenue shares figure? 2.3. A review of recent literature 2.4. Royalty rates in the future Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals 3.1. Partnering agreement structure 3.2. Structure of a typical royalty clause 3.3. Example royalty clauses 3.3.1. Case study 1 3.3.2. Case study 2 3.3.3. Case study 3 3.3.4. Case study 4 Chapter 4 - Companies actively disclosing royalty rates 4.1. Most active companies in disclosing royalty rates Chapter 5 - Royalty rate contract directory Explore royalty rates within the deal contract document to gain greater insight Deal directory Deal Directory - Royalty rates in deals - by company A-Z Deal Directory - Royalty rates in deals - by therapy area Deal Directory - Royalty rates in deals - by stage of development at signing Deal Directory - Royalty rates in deals - by technology type Royalty rate references Example royalty rate deal contract document List of Figures Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024 Figure 2: Components of the partnering deal structure Figure 3: Components of the partnering royalty clause Figure 4: Most active companies disclosing royalty rate 2010 - 2024 Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies Companies Mentioned 2seventy bio 3a-diagnostics 3D Medicines 4SC 23andMe Abbott Laboratories Abbvie Abeona Therapeutics Ablynx Abraxis BioScience ABVC BioPharma ACADIA Pharmaceuticals Acceleron Pharma Acelrx Pharmaceuticals Acer Therapeutics Acerus Acrotech Biopharma Actavis (acquired by Watson) Active Biomaterials Acura Pharmaceuticals Adamis Pharmaceuticals Adaptimmune ADC Therapeutics Adeona Pharmaceuticals Adial Pharmaceuticals Aditx Therapeutics Adlai Nortye Aduro BioTech Advanced Dosage Forms Advanz Pharma Advaxis Advirna Aegerion Pharmaceutical Aeglea BioTherapeutics Aerie Pharmaceuticals AEterna Zentaris Aexon Labs Affimed Therapeutics Afritex Medical Products AFT Pharmaceuticals Agenus Bio Agios Pharmaceuticals Aguettant AiBtl BioPharma AIT Therapeutics Akcea Therapeutics Akebia Therapeutics Albert Einstein College of Medicine Alchemia Alder Biopharmaceuticals Alector Alexion Pharmaceuticals Alexza Pharmaceuticals Alfasigma Alfa Wassermann Allergan Allergan (name changed from Actavis) Almirall Alnylam Pharmaceuticals Alora Pharmaceuticals Alpha Biopharma Alternavida Altman Enterprises AltrazealTrading Altum Pharmaceuticals Alvogen Amarantus BioSciences American Type Culture Collection (ATCC) Amgen Amherst Pharmaceuticals Amorfix Life Sciences Ampio Pharmaceuticals Amryt Pharma Amylin Pharmaceuticals Amyris AnaBios AnaptysBio AnGes MG Angion Biomedica AnnaMed Antares Pharma Antibe Therapeutics Antigen Express Applied Therapeutics Apricus Biosciences Aquestive Therapeutics Aradigm Aratana Therapeutics Arcellx Arch Pharmalabs Arctic Vision Arcturus Therapeutics Arcus Biosciences Ardelyx Arena Pharmaceuticals Arrowhead Pharmaceuticals Artiva Biotherapeutics Arvinas Ascendis Pharma Ascentage Pharma Ashvattha Therapeutics Assembly Biosciences Astellas Pharma Astellas Pharma Europe Asterias Biotherapeutics AstraZeneca Athenex Atossa Therapeutics Atreca Audeo Oncology Augmenta Aurigene Discovery Technologies Aurinia Pharmaceuticals Authentic Brands Group AVEO Oncology Avita Therapeutics Avivagen Axovant Gene Therapies Axsome Therapeutics Aytu BioPharma Azaya Therapeutics Azure Biotech Baker Brothers Investments BAKX Therapeutics Baliopharm BASF Baxter International Bayer Healthcare Bayer Innovation Baylor Research Institute Beam Therapeutics BeiGene Beijing Defengrei Biotechnology Belgian Volition Bellerophon Therapeutics Benitec Biopharma Besins Healthcare Beth Israel Deaconess Medical Center BetterLife Pharma Bharat Biotech BIND Biosciences BioCorRx BioCryst Pharmaceuticals Bioeq IP Biogen BioGene Technology Biohaven Pharmaceuticals BioInvent BiolineRX BioMarin Pharmaceutical BioNovion BioNTech BioNxt Solutions Biopharmex BiopharmX BioPorto Bioprocess Capital Ventures BioProspect Biostem US Biotech Investment Biotechnology Value Fund BioTime Acquisition Bioton Biovail BioZone Laboratories BioZone Pharmaceuticals Blackstone Bluebird Bio Blueprint Medicines BMV Medica Boehringer Ingelheim Bone Therapeutics Braeburn Pharmaceuticals BrainStorm Cell Therapeutics Breathtec BioMedical Brickell Biotech BridgeBio Pharma Bridge Biotherapeutics Bristol-Myers Squibb Caleco Pharma Calico Can-Fite BioPharma Cancer Prevention Pharmaceuticals Cannassure Therapeutics CanniMed Therapeutics Cann Pharmaceutical Australia Canntab Therapeutics Cannus Partners Cantex Pharmaceuticals Cara Therapeutics Cardigant Medical Cardium Therapeutics CareFusion Carna BioSciences Cary Pharmaceuticals CASI Pharmaceuticals Castle Creek Biosciences Catalent CB2 Therapeutics Celdara Medical Celgene Cell Cure Neurosciences Cellvera Cel Sci Celyad Cereal Ingredients Cerebain Biotech Cerus CGA 369 cGreen Chi-Med Chiesi Farmaceutici Chimerix Chong Kun Dang Chongqing Jingdong Pharmaceutical Cimtech Cipher Pharmaceuticals Cipla Circassia Clal Biotech Clalit Health Services Clearmind Medicine Clearside Biomedical Clemson University Cleveland BioLabs Clinigen CMIC CNS Pharmaceuticals Cocrystal Pharma Coeptis Pharmaceuticals CohBar Cohen-McNiece Foundation Coherus Biosciences Colby Pharmaceuticals Collegium Pharmaceuticals Columbia Laboratories Columbia University Common Sense Conatus Pharmaceuticals Concile Consilient Health ContraFect Coronado Biosciences Cosmofix Cosmo Pharmaceuticals Coya Therapeutics CRISPR Therapeutics Crossject Crucell CSL CTI BioPharma CTT Pharmaceutical Cullinan Oncology Cumberland Pharmaceuticals Cures Within Reach CureTech Curis Currax Pharmaceuticals CURx Pharmaceuticals Cutanea Life Sciences Cybin CymaBay Therapeutics Cypress Bioscience Cytodyn Cytokinetics Cytori Therapeutics Daewoong Pharmaceutical Daiichi Sankyo Dana-Farber Cancer Institute Dance Biopharm DAS Therapeutics Defiante Farmaceutica Denali Therapeutics DepoMed Derma Sciences Dermavant Sciences Dermin Dianomi Therapeutics Dicerna Pharmaceuticals DNA Biomedical Solutions Dr. Falk Pharma Dr. Reddy's Laboratories Dragonfly Therapeutics DRI Capital Drugs for Neglected Diseases Initiative DS Healthcare Duke University Dyax Eagle Pharmaceuticals Eagle Pharmaceuticals (US) Easton Pharmaceuticals Echo Therapeutics Ecology Coatings Eczacibasi Pharmaceuticals Eddingpharm Egalet Eisai Elencee Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emory University Enalare Therapeutics Endocyte Endo Pharmaceuticals EnGeneIC Enochian Biosciences Entera Bio Entest BioMedical EnWave Epizyme Epocal Esperion Therapeutics Eternity Healthcare Eton Pharmaceuticals Eureka Genomics EUSA Pharma Evolva Ewopharma Exact Sciences Exelixis ExScientia Eyevance Fairview Health System FasTrack Pharmaceuticals Ferozsons Laboratories Ferring Pharmaceuticals Fibrocell Science Foghorn Therapeutics Forest Laboratories Fosun Pharmaceutical Fox Chase Chemical Diversity Center Fresenius Kabi Pharmaceuticals FSD Pharma Fusion Pharmaceuticals FusionVax Galapagos Galmed Pharmaceuticals GE Healthcare Genentech Generex Biotechnology Genevant Sciences Genexine Genfit Genmab Gentium Genzyme Geron Gilead Sciences Glaukos Glenmark Generics Inc USA Glenmark Pharmaceuticals Goldfinch Bio Government of Israel GPCR Therapeutics Gravocore Grifols GSK GT Biopharma Hai Kang Life Hail First Pharma Hainan Sihuan Pharmaceutical Halo Labs Halozyme Therapeutics Hansen Medical Health Canada Healthcare Royalty Partners Health Discovery Heartseed Heat Biologics Hefei Life Science Hefei Tianhui Incubation of Technologies HekaBio Helsinn Therapeutics HemoCleanse Hemogenyx HemPup Henlius Biotech Hetero Labs HIBM Research Group Hikma Pharmaceuticals Hoffmann La Roche Hollister Biosciences Hookipa Pharma Horizon Pharma Inc Huadong Medicine HyperGenomics I-mab Icahn School of Medicine at Mount Sinai Ice + Jam Iconovo IDC-GP Pharm IDEAYA Biosciences Idera Pharmaceuticals Idorsia Idun Pharmaceuticals IGM Biosciences iMetabolic Biopharma Immugenyx Immunic ImmunityBio Immunomedics Immunomic Therapeutics Immunovative Therapies ImmVira Impax Laboratories Imprimis Pharmaceuticals In4Derm iNAP Incannex Healthcare Incuron Incyte Indiana University Infinity Pharmaceuticals InflaRx Inhibitor Therapeutics Innate Pharma Innocoll Innovate Biopharmaceuticals Innovation Pharmaceuticals Innovent Biologics Innovet Innovus Pharmaceuticals INO Therapeutics Inspiration Biopharmaceuticals Instrumentation Laboratory IntelGenx Intellia Therapeutics IntelliCell BioSciences Intellikine Internet Marketing Consortium Intrexon Intuitive Surgical Invekra Inverness Medical Innovations Ionis Pharmaceuticals Ipsen Iroko Pharmaceuticals Ironwood Pharmaceuticals Israeli National Authority for Technological Innovation Itrom Pharmaceutical Group Ivantis Jaguar Health Janssen Biotech Janssen Pharmaceuticals Jazz Pharmaceuticals JFC Technologies Jiangsu Alphamab Jiangsu Lianhuan Pharmaceuticals Jiangsu NHWA Pharmaceutical Ji Xing Pharmaceuticals John Morley Foods Joincare Pharmaceutical Journey Medical Jubilant Life Sciences Jumpcan Pharmaceutical Juniper Pharmaceuticals Junshi Biosciences Jupiter Wellness Juventas Therapeutics K2M Kadmon Pharmaceuticals Kaken Pharmaceutical Kalbe Genexine Biologics KaloBios Pharmaceuticals Karveer Meditech KemPharm Kensey Nash Kieran Murphy Kinetic Concepts Kiniksa Pharmaceuticals Kintor Kiromic Biopharma Kite Pharma Kitov Pharma Klaria Klinge Biopharma Knighton Foods Knight Therapeutics Kodiak Sciences Kowa Kraig Biocraft Laboratories KVK-Tech Kwang Dong Pharmaceutical Kymera Therapeutics Kyowa Hakko Kirin Kyverna Therapeutics L1 Systems Laboratories Acbel Lantheus Holding Launch Therapeutics Lee Moffitt Cancer Center Legend Biotech LegoChem Biosciences Level Brands LFB Biotechnologies Lifestyle Delivery Systems Ligand Pharmaceuticals Lineage Cell Therapeutics Link Health Lipidor Lipocine Lixte Biotechnology Lorna Linda University Lotus Pharmaceuticals Loxo Oncology Lubrizol Lumenis Lundbeck Lung Therapeutics MabCure Macrogenics Magenta Therapeutics MainPointe Mallinckrodt Pharmaceuticals Marvanal Marv Enterprises Massachusetts General Hospital Matrix Biomed Mayne Pharma McComb Foundation McEwen Centre for Regenerative Medicine Meda Medica Medica Avante Medical Technologies Innovation Asia Medice Arzneimittel Putter Medicines Patent Pool Foundation Medicox MediGene Medigus MedImmune Medison Pharma Medivation Medivir Medovex MEI Pharma Melmed Memory Dx Mercer University Merck and Co Merck KGaA Merck Serono Merus Methodist Hospital Houston Micromet Mikah Pharma Millennium Mimi's Rock Mindset Pharma Ministry of Health Labor and Welfare MiNK Therapeutics Miraculins Miralogx Mira Pharmaceuticals Miromatrix Medical Mitsubishi Tanabe Pharma Moderna Modis Therapeutics Moleculin Biotech Mologen Momenta Pharmaceuticals Monash University Monopar Therapeutics Morgan Stanley MorphoSys Mount Sinai Health System MultiCell Immunotherapeutics Munich Leukemia Laboratory Mylan Laboratories Mylan Pharmaceuticals Myovant Sciences NanoVibronix NanoViricides NantCell NantKwest Nantong Jinghua Pharmaceutical NantWorks Napo Pharmaceuticals Natac Biotech Natco Pharmaceuticals National Green Biomed Nektar Therapeutics Neogenomics Neotope Nephrogenex Nephros Nestle Health Science Neuraxpharm Neurocrine Biosciences NeuroRx NeuroSigma NeuroVive Pharmaceutical NeuroVive Pharmaceutical Asia NewLeaf Brands Newsoara Biopharma New York University NexMed NextCure Nextleaf Solutions Nexvet NGM Biopharmaceuticals Nicox Nkarta Therapeutics NLS Pharmaceutics Nordic Bioscience Norgine NorthStar Medical Radioisotopes Notable Labs Novadaq Technologies NovaDel Pharma Novan Novan Therapeutics Novartis Novartis Vaccines and Diagnostics Novocure Novo Nordisk Novus Biologicals NRx Pharmaceuticals Nucorion Numab Nunzi Pharmaceutical Nurix Therapeutics Nutech Medical NutraOrigin NXTGEN Nymox Pharmaceutical Oberland Capital Ocugen Oculus Innovative Sciences Ocumension Therapeutics Omeros Oncologie Oncolytics Biotech OncoMed Pharmaceuticals Onconova Therapeutics Onegevity One Way Liver Genomics (OWL) ONK Therapeutics Ono Pharmaceutical Onxeo Onyx Pharmaceuticals Opexa Therapeutics Opthea OptiBiotix OptiNose Oragenics Oramed Pharmaceuticals Orexigen Therapeutics Organovo Orgenesis Orion Orox Pharmaceuticals OrthoCyte Otsuka OvaMed Ovid Therapeutics Oxford BioMedica Oxis Biotech Oxygen Biotherapeutics OxySure Systems Oyster Point Pharma Pan-Provincial Vaccine Enterprise Parnell Pharmaceuticals Par Pharmaceutical PDL BioPharma PDS Biotechnology Penwest Pharmaceuticals Pernix Therapeutics Perugia University Pfenex Pfizer Pharmacyclics PharmaCyte Biotech PharmaMar PharmaNova Pharmastrip Philogen Phosphagenics Photocure ASA Phusion Laboratoies Phyto Nutricare Pipex Pharmaceuticals Plandai Biotechnology Pluristem Therapeutics POINT Biopharma Portola Pharmaceuticals Poseida Therapeutics Pozen PreMD Premier Biomedical Professional Compounding Centers of America Progenics Pharmaceuticals Prometic Life Sciences ProQR Therapeutics Prosidion Protagonist Therapeutics Protalix BioTherapeutics Proteonomix Prothena ProtoKinetix Pulmatrix Puma Biotechnology QED Therapeutics QRxPharma Quick Med Technologies Quigley Corporation Quoin Pharmaceuticals Rayner Surgical Reata Pharmaceuticals Recordati Recro Pharma RedHill Biopharma Reedy Creek Investments RegenaStem Regeneron Pharmaceuticals Regenxbio Regnum Relay Therapeutics Relief Therapeutics Relmada Therapeutics RenalytixAI ReNeuron Repare Therapeutics Replicel Life Sciences Repligen Reprise Biomedical Resarci Therapeutics Retrophin rEVO Biologics Revolution Medicines Rigel Pharmaceuticals RNL Bio Roche Rockefeller University Roivant Sciences Royalty Pharma RST Biomedikal Sanayi Ruthigen RXi Pharmaceuticals S2 Therapeutics SACCO Sagard Healthcare Royalty Partners Sage Therapeutics Salix Pharmaceuticals Sam Amer Sanara MedTech Sandoz Sanofi Sanofi-Aventis Sanofi-Pasteur Sanpellegrino Cosmetics Santarus Santen Pharmaceutical Sanuwave Health SA Pathology Sapientia Pharmaceuticals Sarepta Therapeutics Schrodinger Scopus BioPharma Seagen Seattle Genetics Seelos Therapeutics Sekris Biomedical Senetek Senior Paradise Sensory Cloud Seqirus Seres Therapeutics Sermonix Pharmaceutical Sesen Bio SevenScore Pharmaceuticals Shanghai Pharmaceuticals Holdings Sheba Medical Center Shenzhen BioScien Pharmaceuticals Shield Therapeutics Shionogi Shire Pharmaceuticals Shore Therapeutics Siemens Healthcare Diagnostics Sigma-Tau Sinclair Pharmaceuticals Sinobiopharma Sinopharm Sio Gene Therapies Skinvera Skyline Diagnostics Solarvest BioEnergy Soliance Soligenix Sonoma BioTherapeutics Sorrento Therapeutics Spectranetics Spencer Pharmaceutical Spinal USA St. Jude Children's Research Hospital STADA Arzneimittel Staidson (Beijing) BioPharmaceuticals Stanford University Stealth BioTherapeutics Stellar Biotechnologies St Jude Medical Stoke Therapeutics Strongbridge Biopharma Sucampo AG SUDA Pharmaceuticals Sumitomo Dainippon Pharma Sunesis Pharmaceuticals Sunovion Pharmaceuticals Sun Pharmaceutical SuperNova Diagnostics Sutro Biopharma Swedish Orphan Biovitrum SymBio Pharmaceuticals Symbollon Syndax Pharmaceuticals Synergy Strips Syntopix Tactical Relief Taiba TaiGen Biotechnology Taiho Takeda Pharmaceutical Talaris Therapeutics Tango Therapeutics Target Group Tauriga Sciences TB Alliance TearLab Technion Research and Development Foundation Teijin Telomir Pharmaceuticals Tesaro Tetra Bio-Pharma TetraLogic Pharmaceuticals Teva Pharmaceutical Industries Texas A&M University Texas Heart Institute TFF Pharmaceuticals TG Therapeutics Therakine TherapeuticsMD Theravance Theravance Biopharma The Regents of the University of California Thorne Research Threshold Pharmaceuticals TiGenix Tilray Titterington Veterinary Services Tiziana Life Sciences Tocagen TONIX Pharmaceuticals Torii Pharmaceutical TRACON Pharmaceuticals Tramorgan Transgene Travere Therapeutics Trellis Bioscience Trevena Trimedyne Trimeris TrovaGene TTFactor Tufts University Turnstone Biologics Tyme Technologies Ultragenyx Pharmaceuticals Uluru Unigene Laboratories UniQure Universal Cells University College Dublin University Health Network University of Alberta University of California University of Central Florida Research Foundation University of Colorado University of Florida Research Foundation University of Geneva University of Louisville University of Missouri University of Notre of Dame University of Pennsylvania University of Texas University of Virginia University of Western Sydney University of Zurich UOP Uppsalagruppen Medical Upstream Peripheral Technologies UroGen Pharma Valeant Pharmaceuticals ValiPharma Valneva Valor Biotherapeutics Vanderbilt University Vasomune Therapeutics Vaxent VBL Therapeutics Veloxis Pharmaceuticals Veracyte Verenium Verity Pharmaceuticals VeroScience Vertex Pharmaceuticals Vida Concepts Vifor Pharma ViiV Healthcare Virbac Viropharma VistaGen Therapeutics Vividion Therapeutics Vivus VolitionRX Voronoi Voyager Therapeutics Vyera Pharmaceuticals VYNE Therapeutics Vyrix Pharmaceuticals Watson Pharmaceuticals WAVE Life Sciences Wigen Biomedicine Wisconsin Alumni Research Foundation World Class Extractions WPD Pharmaceuticals WUGEN Xbrane Bioscience Xencor Xlife Sciences XPhyto Therapeutics XTL Biopharmaceuticals Xynomic Pharmaceuticals Yale University Yeda Research and Development Company Yeugnam University Yissum Research Development ZAI Laboratory Zalicus Zenitech Zenith Epigenetics Ziopharm Oncology Zogenix ZS Pharma Zymeworks For more information about this report visit https://www.researchandmarkets.com/r/pilfnx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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