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Innoviva Reports Third Quarter 2024 Financial Results; Highlights Recent Company Progress

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Innoviva reported third quarter 2024 financial results, highlighting strong performance and significant progress. Key points include:

Royalty revenue: $60.5 million from GSK, a 6% year-over-year increase.

Net product sales: $27.8 million, with U.S. sales at $19.7 million, reflecting a 68% growth. GIAPREZA® contributed $13.1 million, XERAVA® $2.3 million, and XACDURO® $4.3 million.

License revenue: $4.6 million from development cost-sharing reimbursements.

Net income: $1.2 million, or $0.02 per share, down from $82.0 million, or $1.26 per share in Q3 2023.

Cash and assets: $260.6 million in cash and equivalents, with $91.1 million in receivables.

Notable achievements include the nomination of XACDURO® for the 2024 Prix Galien USA Award and plans to submit an NDA for zoliflodacin in early 2025.

Innoviva ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando performance solide e progressi significativi. I punti chiave includono:

Entrate da royalties: $60,5 milioni da GSK, un aumento del 6% rispetto all’anno precedente.

Vendite nette di prodotti: $27,8 milioni, con vendite negli Stati Uniti pari a $19,7 milioni, che riflettono una crescita del 68%. GIAPREZA® ha contribuito con $13,1 milioni, XERAVA® con $2,3 milioni e XACDURO® con $4,3 milioni.

Entrate da licenze: $4,6 milioni derivanti da rimborsi per la condivisione dei costi di sviluppo.

Utile netto: $1,2 milioni, ovvero $0,02 per azione, in calo rispetto a $82,0 milioni, ovvero $1,26 per azione nel Q3 2023.

Liquidità e attività: $260,6 milioni in contante e equivalenti, con $91,1 milioni in crediti.

Tra i risultati notevoli c'è la nomination di XACDURO® per il 2024 Prix Galien USA Award e i piani per presentare una NDA per zoliflodacina all'inizio del 2025.

Innoviva informó los resultados financieros del tercer trimestre de 2024, destacando un rendimiento sólido y avances significativos. Los puntos clave incluyen:

Ingresos por regalías: $60.5 millones de GSK, un incremento del 6% en comparación con el año anterior.

Ventas netas de productos: $27.8 millones, con ventas en EE. UU. de $19.7 millones, lo que refleja un crecimiento del 68%. GIAPREZA® contribuyó con $13.1 millones, XERAVA® con $2.3 millones y XACDURO® con $4.3 millones.

Ingresos por licencias: $4.6 millones de reembolsos por compartición de costos de desarrollo.

Ingreso neto: $1.2 millones, o $0.02 por acción, una disminución respecto a $82.0 millones, o $1.26 por acción en el tercer trimestre de 2023.

Efectivo y activos: $260.6 millones en efectivo y equivalentes, con $91.1 millones en cuentas por cobrar.

Logros notables incluyen la nominación de XACDURO® para el Premio Prix Galien USA 2024 y planes para presentar una NDA para zoliflodacina a principios de 2025.

Innoviva가 2024년 3분기 재무 결과를 보고하며 강력한 성과와 상당한 발전을 강조했습니다. 주요 사항은 다음과 같습니다:

로열티 수익: GSK로부터의 $60.5 백만으로 전년 대비 6% 증가했습니다.

순 제품 판매: $27.8 백만, 미국 판매는 $19.7 백만으로 68% 증가했습니다. GIAPREZA®는 $13.1 백만, XERAVA®는 $2.3 백만, XACDURO®는 $4.3 백만을 기여했습니다.

라이센스 수익: 개발 비용 분담에 대한 환급금으로 $4.6 백만입니다.

순 이익: $1.2 백만, 즉 주당 $0.02로, 2023년 3분기의 $82.0 백만 또는 주당 $1.26에서 감소했습니다.

현금 및 자산: 현금 및 현금성 자산 $260.6 백만, 수취채권은 $91.1 백만입니다.

눈에 띄는 성과에는 XACDURO®의 2024 Prix Galien USA Award 후보 지명과 2025년 초에 zoliflodacin에 대한 NDA 제출 계획이 포함됩니다.

Innoviva a présenté les résultats financiers du troisième trimestre 2024, mettant en avant des performances solides et des progrès significatifs. Les points clés comprennent :

Revenus de redevances : 60,5 millions de dollars de GSK, soit une augmentation de 6 % par rapport à l’année précédente.

Ventes nettes de produits : 27,8 millions de dollars, avec des ventes aux États-Unis atteignant 19,7 millions de dollars, ce qui représente une croissance de 68 %. GIAPREZA® a contribué à hauteur de 13,1 millions de dollars, XERAVA® de 2,3 millions de dollars et XACDURO® de 4,3 millions de dollars.

Revenus de licences : 4,6 millions de dollars provenant des remboursements de partage des coûts de développement.

Revenu net : 1,2 million de dollars, soit 0,02 $ par action, en baisse par rapport à 82,0 millions de dollars, soit 1,26 $ par action au T3 2023.

Liquidités et actifs : 260,6 millions de dollars en liquidités et équivalents, avec 91,1 millions de dollars en créances.

Parmi les réalisations notables figure la nomination de XACDURO® pour le Prix Galien USA 2024 et les projets de soumettre une NDA pour la zoliflodacine début 2025.

Innoviva hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und hebt starke Leistungen und signifikante Fortschritte hervor. Zu den wichtigsten Punkten gehören:

Lizenzgebühren: $60,5 Millionen von GSK, ein Anstieg von 6% im Jahresvergleich.

Nettoumsatz: $27,8 Millionen, wobei der Umsatz in den USA $19,7 Millionen beträgt, was einem Wachstum von 68% entspricht. GIAPREZA® trug mit $13,1 Millionen bei, XERAVA® mit $2,3 Millionen und XACDURO® mit $4,3 Millionen.

Lizenzgebühren: $4,6 Millionen aus Erstattungen für Entwicklungskosten.

Nettoeinkommen: $1,2 Millionen, bzw. $0,02 pro Aktie, ein Rückgang von $82,0 Millionen, bzw. $1,26 pro Aktie im Q3 2023.

Barmittel und Vermögenswerte: $260,6 Millionen an Bargeld und Äquivalenten, mit $91,1 Millionen an Forderungen.

Bemerkenswerte Erfolge umfassen die Nominierung von XACDURO® für den Prix Galien USA Award 2024 und die Pläne zur Einreichung eines NDA für zoliflodacin Anfang 2025.

Positive
  • 6% year-over-year growth in royalty revenue from GSK, totaling $60.5 million.
  • 68% year-over-year growth in U.S. net product sales, reaching $19.7 million.
  • Nomination of XACDURO® for the 2024 Prix Galien USA Award.
  • Plans to submit an NDA for zoliflodacin in early 2025.
Negative
  • Net income decreased significantly to $1.2 million from $82.0 million in Q3 2023.
  • Unfavorable net change in fair value of equity and long-term investments by $35.2 million, primarily due to lower share price of Armata Pharmaceuticals.

Insights

The Q3 2024 results show mixed performance. Core royalty revenue from GSK grew 6% year-over-year to $60.5 million, while IST's U.S. product sales jumped 68% to $19.7 million. However, net income declined significantly to $1.2 million ($0.02 per share) from $82.0 million ($1.26 per share) in Q3 2023, primarily due to a $35.2 million loss from equity investments.

The company maintains a strong balance sheet with $260.6 million in cash and $91.1 million in receivables. The commercial portfolio shows promising growth, particularly GIAPREZA® with $13.1 million in sales. The upcoming zoliflodacin NDA submission in early 2025 represents a significant growth catalyst.

The pipeline developments and clinical data presentations demonstrate solid progress in Innoviva's infectious disease portfolio. XACDURO®'s Prix Galien USA Award nomination validates its innovative approach to treating resistant Acinetobacter infections. The zoliflodacin program shows particular promise, with multiple positive data presentations supporting its potential as a first-in-class treatment for gonorrhea. The successful Phase 3 results and planned FDA submission position it as a significant near-term value driver.

Core royalty platform continued strong performance, receiving GSK royalties of $60.5 million with 6% year-over-year growth

Innoviva Specialty Therapeutics’ (IST) marketed portfolio achieved U.S. net product sales of $19.7 million, reflecting 68% year-over-year growth

BURLINGAME, Calif.--(BUSINESS WIRE)-- Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the third quarter ended September 30, 2024, and highlighted select corporate achievements.

“For the third quarter of 2024, we continue to deliver strong revenue growth, with solid performance from our core GSK royalty assets, and accelerating sales from our IST commercial products, GIAPREZA®, XACDURO® and XERAVA®. Since the formation of IST, now in its second year of operation, we have shown consistent sales expansion in our commercial products, primarily driven by increasing product demand, validating our investment in hospital-based therapeutics,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Of special note, XACDURO® was nominated for the Best Biotechnology Product by The Galien Foundation USA in recognition of its pioneering science and positive impact on patients. We are proud of this recognition which highlights the commitment and innovation we are bringing to this space, where there is significant unmet medical need and an immense demand for new drugs. We also continue to further advance our pipeline and are on track to submit a New Drug Application (“NDA”) for zoliflodacin, potentially first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the U.S. FDA in early 2025.”

Mr. Raifeld continued, “Over the past quarter, we also saw meaningful operational progress across our strategic healthcare assets. We remain focused on prudent capital allocation in our quest to maximize shareholder value and see multiple opportunities for continued value creation.”

Financial Highlights

  • Royalty revenue: Third quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $60.5 million, compared to $57.0 million for the third quarter 2023.
  • Net Product Sales: Third quarter 2024 net product sales were $27.8 million, which included U.S. net product sales of $19.7 million and ex-U.S. product sales of $8.1 million. U.S. net product sales consisted of $13.1 million from GIAPREZA®, $2.3 million from XERAVA®, and $4.3 million from XACDURO®, a 68% increase compared to $11.8 million for the third quarter 2023.
  • License Revenue: Third quarter 2024 license revenue of $4.6 million included product development cost-sharing reimbursements from our partner.
  • Equity and long-term investments: Third quarter 2024 unfavorable net change in fair value of equity and long-term investments of $35.2 million was primarily due to lower share price of Armata Pharmaceuticals (“Armata”).
  • Net income: Net income of $1.2 million, or $0.02 basic per share, for the third quarter of 2024, compared to a net income of $82.0 million, or $1.26 basic per share, for the third quarter of 2023.
  • Cash and cash equivalents: Totaled $260.6 million. Royalty and product sales receivables totaled $91.1 million as of September 30, 2024.

Key Business and R&D Highlights

  • XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
    • XACDURO® was recently nominated for the 2024 Prix Galien USA Award for Best Biotechnology Product, which recognizes excellence in scientific innovation that improves the state of human health.
  • Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea.
    • In September 2024, we presented additional findings on our investigational agent zoliflodacin at the 2024 Sexually Transmitted Infections Prevention Conference in Atlanta. The first oral presentation demonstrated that zoliflodacin had potent in vitro activity against 200 clinical isolates, consistent with previous U.S. surveillance data. The second presentation demonstrated that microbiological cure rates for specific subgroups were comparable to the primary endpoint analysis. Safety in these subgroups was also comparable.
    • In October 2024, we had five presentations at IDWeek 2024, which took place in Los Angeles. One oral presentation on zoliflodacin included a review of the unique public-private partnership that led the clinical development of zoliflodacin. The second presentation highlighted the activity of sulbactam-durlobactam and standard-of-care antibiotics against Acinetobacter baumannii-calcoaceticus complex for hospitalized patients in the U.S. Three posters were presented including two on zoliflodacin: In vitro activity against baseline isolates in U.S. participants from the phase 3 trial and a pharmacometrics analysis supporting dose selection. Surveillance data of eravacycline against clinical pathogens, collected worldwide from multiple infections sites during 2018-2022 was also presented.
    • We continue to advance zoliflodacin following its successful Phase 3 clinical trial results and expect to submit an NDA to the U.S. FDA in early 2025.

About Innoviva

Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults.

ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies.

Forward Looking Statements

This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

INNOVIVA, INC.
Condensed Consolidated Statements of Income and Comprehensive Income
(in thousands, except per share data)
(unaudited)
                 
    Three Months Ended   Nine Months Ended
  September 30,    September 30, 
 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Revenue:                
    Royalty revenue, net (1)  

 $

                57,056

 

 

 $

           53,558

 

 

 $

              179,213

 

 

 $

         172,681

 

    Net product sales  

 

                   27,822

 

 

 

              13,701

 

 

 

                   68,557

 

 

 

              40,942

 

    License revenue  

 

                     4,630

 

 

 

                       -

 

 

 

                   19,135

 

 

 

              11,000

 

Total revenue  

 

                   89,508

 

 

 

              67,259

 

 

 

                 266,905

 

 

 

            224,623

 

Expenses:                
    Cost of products sold (inclusive of amortization of inventory fair value adjustments)  

 

                     9,990

 

 

 

              10,182

 

 

 

                   29,433

 

 

 

              27,910

 

    Cost of license revenue  

 

                             -

 

 

 

                       -

 

 

 

                             -

 

 

 

                1,600

 

    Selling, general and administrative  

 

                   26,219

 

 

 

              28,636

 

 

 

                   84,364

 

 

 

              71,913

 

    Research and development  

 

                     3,551

 

 

 

                3,989

 

 

 

                     9,989

 

 

 

              31,566

 

    Amortization of acquired intangible assets  

 

                     6,511

 

 

 

                6,511

 

 

 

                   19,391

 

 

 

              15,274

 

    Changes in fair values of equity method investments, net  

 

                   18,231

 

 

 

            (71,980

)

 

 

                   42,997

 

 

 

            (67,886

)

    Changes in fair values of equity and long-term investments, net  

 

                   16,936

 

 

 

                2,640

 

 

 

                   60,827

 

 

 

                4,887

 

    Interest and dividend income   

 

                    (5,500

)

 

 

              (4,114

)

 

 

                  (13,373

)

 

 

            (11,032

)

    Interest expense  

 

                     5,807

 

 

 

                4,396

 

 

 

                   17,460

 

 

 

              13,205

 

    Other expense, net  

 

                        914

 

 

 

                1,047

 

 

 

                     3,123

 

 

 

                4,289

 

Total expenses, net

 

                   82,659

 

 

            (18,693

)

 

 

                 254,211

 

 

              91,726

 

Income before income taxes  

 

                     6,849

 

 

 

              85,952

 

 

 

                   12,694

 

 

 

            132,897

 

Income tax expense, net  

 

                     5,636

 

 

 

                3,906

 

 

 

                     9,634

 

 

 

              14,706

 

          Net income and comprehensive income  

 $

                  1,213

 

 

 $

           82,046

 

 

 $

                  3,060

 

 

 $

         118,191

 

                 
Net income per share                
Basic

 $

                    0.02

 

 $

               1.26

 

 

 $

                    0.05

 

 $

               1.79

 

Diluted

 $

                    0.02

 

 $

               0.98

 

 

 $

                    0.05

 

 $

               1.45

 

   
Shares used to compute net income per share  
Basic

 

                   62,569

 

 

              64,953

 

 

 

                   62,759

 

 

              66,016

 

Diluted

 

                   62,951

 

 

              86,164

 

 

 

                   63,020

 

 

              87,504

 

(1) Total net revenue is comprised of the following (in thousands):            
                 
    Three Months Ended   Nine Months Ended
September  30,   September  30,
   

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

    (unaudited)   (unaudited)
                 
Royalties  

 $

        60,512

 

 

 $

       57,014

 

 

 $

      189,581

 

 

 $

     183,049

 

Amortization of capitalized fees   

 

            (3,456

)

 

 

           (3,456

)

 

 

          (10,368

)

 

 

         (10,368

)

     Royalty revenue, net  

 $

        57,056

 

 

 $

       53,558

 

 

 $

      179,213

 

 

 $

     172,681

 

INNOVIVA, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
       
  September 30,   December 31,
 

 

2024

 

 

2023

Assets      
Cash and cash equivalents

 $

                  260,630

 

 $

                  193,513

Royalty and product sale receivables

 

                       91,058

 

 

                       84,075

Inventory

 

                       34,236

 

 

                       40,737

Prepaid expense and other current assets

 

                       14,697

 

 

                       25,894

Property and equipment, net  

 

                            544

 

 

                            483

Equity and long-term investments

 

                     507,718

 

 

                     560,978

Capitalized fees paid, net

 

                       73,416

 

 

                       83,784

Right-of-use assets

 

                         2,789

 

 

                         2,536

Goodwill

 

                       17,905

 

 

                       17,905

Intangible assets

 

                     210,944

 

 

                     230,335

Deferred tax asset, net

 

                       14,875

 

 

                               -  

Other assets

 

                         2,800

 

 

                         3,267

          Total assets

 $

               1,231,612

 

 $

               1,243,507

       
       
Liabilities and stockholders’ equity      
Other current liabilities 

 $

                    30,357

 

 $

                    33,435

Accrued interest payable

 

                            833

 

 

                         3,422

Deferred revenue

 

                            717

 

 

                         1,277

Convertible senior notes, due 2025, net

 

                     191,843

 

 

                     191,295

Convertible senior notes, due 2028, net

 

                     255,972

 

 

                     254,939

Other long-term liabilities

 

                       71,449

 

 

                       71,870

Deferred tax liabilities, net

 

                                 -

 

 

                            563

Income tax payable, long-term

 

                       11,899

 

 

                       11,751

Innoviva stockholders’ equity 

 

                     668,542

 

 

                     674,955

          Total liabilities and stockholders’ equity 

 $

               1,231,612

 

 $

               1,243,507

INNOVIVA, INC.
Cash Flows Summary
(in thousands)
(unaudited)
   
  Nine Months Ended
  September 30,
 

 

2024

 

 

 

2023

 

Net cash provided by operating activities  

 $

      129,451

 

 

 $

          107,808

 

Net cash used in investing activities  

 

          (48,308

)

 

 

              (61,610

)

Net cash used in financing activities  

 

          (14,026

)

 

 

            (157,250

)

Net change

 

           67,117

 

 

 

            (111,052

)

Cash and cash equivalents at beginning of period

 

         193,513

 

 

 

             291,049

 

Cash and cash equivalents at end of period

 $

      260,630

 

 

 $

          179,997

 

 

Innoviva, Inc.

David Patti

Corporate Communications

(908) 421-5971

david.patti@inva.com

Investors and Media:

Argot Partners

(212) 600-1902

innoviva@argotpartners.com

Source: Innoviva, Inc.

FAQ

What was Innoviva's royalty revenue for Q3 2024?

Innoviva's royalty revenue for Q3 2024 was $60.5 million, a 6% increase year-over-year.

How much were Innoviva's net product sales in Q3 2024?

Innoviva's net product sales in Q3 2024 were $27.8 million, with U.S. sales at $19.7 million, reflecting a 68% year-over-year growth.

What was Innoviva's net income for Q3 2024?

Innoviva's net income for Q3 2024 was $1.2 million, or $0.02 per share.

What are Innoviva's cash and cash equivalents as of Q3 2024?

As of Q3 2024, Innoviva had $260.6 million in cash and cash equivalents.

What future plans does Innoviva have for zoliflodacin?

Innoviva plans to submit a New Drug Application for zoliflodacin to the U.S. FDA in early 2025.

Innoviva, Inc.

NASDAQ:INVA

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1.26B
62.60M
1.07%
118.4%
18.54%
Biotechnology
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