España: MSD sube en bolsa...adquisiciones y aprobaciones.

 

La compañía biomédica MSD, conocida como Merck en Estados Unidos, ha registrado un gran primer semestre de 2024 en términos bursátiles a nivel global, especialmente durante el inicio del año. Prueba de ello es su rendimiento en el mayor mercado de valores del mundo, la Bolsa de Nueva York, influenciado principalmente por las adquisiciones llevadas a cabo en este periodo y las numerosas aprobaciones por parte de la Agencia del Medicamento de Estados Unidos (FDA, por sus siglas en inglés).

Tras un aumento del 6,38% en diciembre de 2023, la compañía norteamericana comenzaba el año con un valor de 109,16 dólares (101,85 euros) la acción, que en tan solo un mes subió hasta los 120,78 dólares (112,62 euros) un 10,79% más. Continuando con la tendencia positiva, en febrero la farmacéutica incrementó de nuevo su valor por acción, en esta ocasión un 5,27%, que seguido del aumento del 3,78% dejarían un gran primer trimestre, con 22,79 dólares (21,26 euros) y un 19,84% más.

Tras un sorpresivo aumento del 6,38% en diciembre de 2023, la compañía norteamericana comenzaba el año con un valor de 101,85 euros la acción, que en tan solo un mes subió hasta los 112,62, un 10,79% más Por parte del segundo trimestre no ha sido tan positivo, en abril cayeron a números rojos, después de encadenar cinco meses en positivo. Una inclinación negativa que continuó tanto en mayo como en junio, provocando así que el valor por acción de MSD se situase en los 123,80 dólares (115,51 euros) a cierre de junio.

A pesar de los registros de estos tres últimos meses, el resultado de la compañía en el primer semestre es muy positivo, gracias al buen momento que atravesaron tanto en enero, con esa subida de más del 10%, como en febrero y marzo, que alcanzaron el 8% entre ambos. En términos totales, los seis primeros meses de 2024 de MSD dejan un incremento de 14,64 dólares (13,66 euros), lo que se traduce en un crecimiento del 13,53%.

ADQUISICIONES Y APROBACIONES

Estos seis meses para la compañía norteamericana han estado influenciados principalmente por las adquisiciones que han llevado a cabo, el refuerzo de su compromiso con la sostenibilidad, y las múltiples aprobaciones que han ido recibiendo por parte de la FDA.

En cuanto a las adquisiciones, en los primeros días del año, la empresa global de productos farmacéuticos anunció un acuerdo con el laboratorio Harpoon Therapeutics por un total de 680 millones de dólares (634,47 millones de euros) con el objetivo de diversificar su cartera de tratamientos oncológicos. Una operación que, tal y como apuntó el presidente de Merck Research Laboratories, Dean Y. Li, supone un gran paso para MSD, “las adquisiciones estratégicas complementan nuestra cartera actual y promueven avances científicos revolucionarios para ayudar a abordar las necesidades de las personas con cáncer en todo el mundo", añadió.

Continuando con las adquisiciones, a finales de mayo, la compañía estadounidense comunico la compra de Eyebiotech Limited (EyeBio), una empresa privada de biotecnología centrada en la oftalmología. En este caso, la cifra monetaria se situó en los 3.000 millones de dólares (2.799 millones de euros), incluido un pago inicial de 1.300 millones de dólares (1.202 millones de euros) y otros 1.700 millones de dólares (1.586 millones de euros) potenciales en pagos por hitos comerciales, regulatorios y de desarrollo.

“Las adquisiciones estratégicas complementan nuestra cartera actual y promueven avances científicos revolucionarios para ayudar a abordar las necesidades de las personas con cáncer en todo el mundo" Por parte de la compañía adquirida, se encuentra en desarrollo de una cartera de candidatos clínicos y preclínicos para la prevención y el tratamiento de la pérdida de visión asociada con la fuga vascular retiniana, un factor de riesgo para las posteriores enfermedades de la retina. "Seguimos ejecutando nuestra estrategia de desarrollo empresarial basada en la ciencia para ampliar y diversificar nuestra cartera. El equipo de EyeBio, bajo el liderazgo del Dr. David Guyer y el Dr. Tony Adamis, tiene una sólida trayectoria en el desarrollo de terapias oftalmológicas innovadoras”, destacó Dean Y. Li.

Además de los acuerdos alcanzados con otras compañías, MSD ha conseguido contabilizar este gran primer semestre en bolsa gracias a las aprobaciones de la FDA, que demuestran que la compañía va por un buen camino. Como por ejemplo el tratamiento de adultos con hipertensión arterial pulmonar (HAP) para mejorar la capacidad de ejercicio y reducir el riesgo de eventos de empeoramiento clínico. Este fármaco biológico innovador, se trata del primer tratamiento innovador ador de la señalización de activina aprobado por la FDA para la HAP.

Otro de los puntos en los que ha puesto en especial el foco MSD en este semestre ha sido la enfermedad neumocócica en adultos, alcanzando la aprobación de la FDA a mediados de junio de su vacuna de próxima generación. Bajo el nombre de Capvaxive, han conseguido producir una respuesta inmune contra los 21 serotipos, o variaciones de la bacteria, a los que se dirigió la inyección en una variedad de poblaciones adultas en los estudios. En esta misma línea, en el día de ayer la compañía comunicó que la FDA también había aprobado su terapia V116 en Estados Unidos y se encuentra en proceso de revisión por la Agencia Europea de Medicamentos (EMA).

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Merck compra EyeBio

 

Merck announced it is buying ophthalmology startup EyeBio in a deal worth up to $3 billion Wednesday morning.

Through a subsidiary, the pharma giant is paying $1.3 billion upfront for the eye-focused biotech and could pay another $1.7 billion in milestone payments.

EyeBio’s board of directors unanimously approved the deal, which is still subject to customary closing conditions and regulatory approvals. The transaction is expected to close in Q3, at which point Merck will record a $1.3 billion charge in its non-GAAP financials.

By scooping up EyeBio, Merck is expanding its ophthalmology offerings and bolstering its vision care pipeline. The prize jewel of the transaction is Restoret (EYE103), a novel, investigational, tetravalent and tri-specific antibody.

Restoret acts as an agonist of the Wingless-related integration site signaling pathway and has shown potential in a Phase 1b/2a trial treating patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).

Merck stated that Restoret is expected to advance into a Phase 2b/3 trial for treating patients with DME in the second half of the year.

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Nuevas fusiones: NOVO, GILEAD, NOVARTIS...

 

Según la consultora, que destaca siete adquisiciones valoradas en más de mil millones, incluida una por encima de los 10 mil millones de dólares (9.240 millones de euros), estos datos auguran un gran año de fusiones y adquisiciones para el sector biofarmacéutico, ya que el total del primer trimestre ha eclipsado los totales inferiores a 10.000 millones de dólares que tuvieron lugar en el primer trimestre de 2020 y 2022, y fue significativamente superior a los más de 22.000 millones de dólares registrados en el primer trimestre de 2021.

El acuerdo más importante del trimestre ha sido el de Novo Holdings, el accionista mayoritario de Novo Nordisk. El grupo se hizo en febrero con Catalent por 16.500 millones de dólares. El objetivo, según se desprende del documento de Evaluate, es mantener su posición líder en el campo de la diabetes tipo 2 y la obesidad gracias al aumento de la producción de semaglutida, un medicamento antidiabético que se usa para el tratamiento de estas enfermedades.

Como parte de la transacción, Novo Nordisk pagará 11.000 millones de dólares para adquirir tres plantas de fabricación de Catalent (dos en Europa y una en EEUU) para aumentar la capacidad de llenado y acabado de productos que contienen semaglutida, como Ozempic, que generó a la farmacéutica 14.000 millones de dólares en ventas durante 2023, y Wegovy, por el cual la empresa danesa ingresó 4.360 millones de dólares.

Apuesta por transacciones más pequeñas El resto de los acuerdos de fusiones y adquisiciones del primer trimestre fueron significativamente más pequeños. Y es que desde 2023, el sector ha dejado atrás las grandes compras y se centra en las pequeñas y medianas empresas debido al mayor escrutinio regulatorio que suele rodear a las grandes operaciones de compraventa en el sector.

El segundo acuerdo más importante del trimestre fue el de Gilead Sciences, que reforzó su apuesta por las enfermedades hepáticas al invertir 4.300 millones de dólares en CymaBay Therapeutics y su agonista PPAR delta de fase III seladelpar para la colangitis biliar primaria. Anunciado el 12 de febrero, el acuerdo se cerró rápidamente el 22 de marzo. CymaBay, con sede en Hayward, California, presentó en diciembre a la Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de EEUU una nueva solicitud de aprobación del fármaco.

El tercer acuerdo más grande en los primeros tres meses de 2024 vino de la mano de Novartis AG, que el pasado 6 de febrero hizo una oferta de 68 dólares por acción por la alemana MorphoSys AG. Una transacción, según Evaluate, valorada en aproximadamente 2.910 millones de dólares y que se espera que se cierre durante la primera mitad de 2024. MorphoSys, que anunció el 22 de marzo que la operación propuesta había superado la revisión de la Comisión Federal de Comercio de Estados Unidos, ha realizado varios estudios de fase III del candidato a mielofibrosis pelabresib y afirma que el inhibidor de BET puede aprobarse, a pesar de algunos resultados dispares en esos ensayos.

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NOVARTIS / MORPHO Sys: A veces SI, a veces NO. / Incoherencias...

 

Feb 6 (Reuters) - 

Drugmaker Novartis AG , opens new tab said it will acquire MorphoSys AG , opens new tab, a developer of cancer treatments, for 2.7 billion euros ($2.9 billion), adding a promising rare bone-marrow cancer treatment candidate to its portfolio.

Reuters first reported on Monday that Switzerland-based Novartis was in advanced talks to acquire MorphoSys, leading to the German biotech firm's shares surging more than 40%.

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 Adam Feuerstein Feb. 6, 2024

Novartis said Monday that it intends to buy MorphoSys for just under $3 billion. The deal will not close. Six months from now, or sooner, Novartis will walk away — slightly embarrassed but otherwise unscathed — happy to pay a small breakup fee to MorphoSys to avoid owning a drug for myelofibrosis that regulators turned away.

MorphoSys will not fare as well from the breakup. Its future, and that of the drug called pelabresib at the center of the deal, will be thrown into limbo.

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J&J, MERCK and NOVARTIS 2024 slew of acquisitions...

 

As the kicked off in San Francisco Monday morning, three Big Pharma pharma players — Johnson & Johnson, Merck and Novartis — all announced major acquisitions.

Below is a breakdown of the trio of biotech buyouts:

 ~~J&J is putting down $2 billion to eat up more of the increasingly attractive antibody drug conjugate (ADC) space, acquiring Ambrx Biopharma and its proprietary synthetic biology technology platform.

~~Meanwhile, Merck’s acquisition of Harpoon Therapeutics, also announced Monday morning, is the second largest of the trio – worth up to $680 million.

The deal expands Merck’s immunotherapy business and gives the company access to Harpoon’s novel T-cell engager portfolio, including its lead candidate HPN328, which targets delta-like ligand 3 in small cell lung cancer and neuroendocrine tumors.

~~Finally, Novartis unveiled its acquisition of Calypso Biotech, with an upfront payment of $250 million and potential milestones worth up to $175 million.

The deal will give Novartis full rights to CALY-002, Calypso’s lead candidate, which Novartis dubs a “pipeline-in-a-drug.” CALY-002, a therapeutic antibody that neutralizes a protein called Interleukin-15, is currently being investigated in a Phase 1b trial for the treatment of celiac disease and eosinophilic esophagitis – but may hold potential in other autoimmune indications.

“As part of the Novartis portfolio, CALY-002 is the best position to be developed effectively, so that it can promptly address unmet medical needs in multiple indications,” said Calypso CEO Alain Vicari in a statement.

The moves follow a busy few months for both Merck and Novartis. Merck acquired Caraway Therapeutics for up to $610 million in November 2023. It also picked up three clinical ADCs from Daiichi Sankyo earlier in the fall for $5.5 billion upfront and $16.5 billion in potential milestones.

At the start of the year, Novartis signed a gene therapy deal with Voyager for up to $1.3 billion total, giving it access to Voyager’s TRACER capsids for spinal muscular atrophy (SMA).

Sandoz y Novartis rompen...

 

Sandoz has completed its separation from Novartis, with the business now continuing as an independent spin-off company.

The separation allows Novartis to fully focus its attention on innovative medicines, the former parent company said, while Sandoz can continue to strengthen its position in generics and biosimilars.

In an announcement, Novartis proposed a stock distribution scheme, offering shareholders one Sandoz share for every five of its own, with all holders set to benefit from “capital and management attention fully focused on innovative medicines”.

Additionally, Novartis said that it “is well-positioned for sustained top- and bottom-line growth”.

Meanwhile, Sandoz has said that it sits in a strong position for “continued profitable growth as a standalone global leader” in generic and biosimilar medicines, following the completion of its first trading day on the SIX Swiss exchange as an independent company.

Sandoz was valued at 10.3bn Swiss francs ($11.2bn), a lower value than previously predicted by analysts of $11bn to $26bn.

Currently, generics and biosimilars account for around 80% of medicines globally, at around 25% of the total cost, with the industry set to grow steadily over the next decade.

Novartis will focus on four core therapeutic areas, cardiovascular, renal and metabolic, immunology, neuroscience and oncology, and will prioritise two established technology platforms, as well as three next-generation platforms to continue its investment in research and development (R&D) capabilities and manufacturing.

Each of these areas will provide the opportunity to address the high disease burden as well as the potential for substantial growth, particularly in the US, China, Germany and Japan.

“Sandoz starts out from a position of strength as a global leader in generics and biosimilars, and I am confident they are poised to deepen their impact on patients and society,” said Narasimhan chief executive officer of Novartis.

He added that Novartis will enter “this new era with strong financial performance and R&D momentum” to “reimagine medicine for and with patients around the globe”.

Chief executive officer of Sandoz, Richard Saynor, commented: “As an independent company, Sandoz will be fully enabled to deliver on its purpose-driven strategy, which targets sustainable leadership in the growing and critical generics and biosimilars industry.”

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Lilly dice que apuesta por la inmunología y...compra DICE

 

Eli Lilly has entered into an agreement to acquire Dice Therapeutics for approximately $2.4bn, marking a significant boost to its immunology pipeline.

The deal grants Lilly access to the biopharma’s lead candidate, DC-806, an oral small-molecule inhibitor of the pro-inflammatory cytokine interleukin-17 (IL-17) currently in phase 2 development for psoriasis.

Dice said DC-806 had "best-in-class” potential in October last year when it announced positive results from an early-stage trial of the drug, which was associated with a 43.7% reduction in psoriasis area and severity.

The acquisition also includes a second candidate, DC-853, which is being developed as a "fast follower" to DC-806, meaning it should have improved potency and metabolic stability. A topline readout from an early-stage trial of the IL-17 inhibitor is expected in the second half of this year.

Dice is also developing oral therapeutic candidates targeting the integrin α4ß7 for the treatment of inflammatory bowel disease.

Kevin Judice, Dice’s chief executive officer, said: "We're eager to see our pipeline, including our oral IL-17 inhibitors, DC-806 and DC-853, benefit from Lilly's resources and global reach and I'm excited by the prospect of watching these two talented teams in a united quest for scientific innovation.

"Our novel approach to discovering and advancing oral, small molecules against validated protein-protein interaction targets has even greater potential with Lilly's industry-leading clinical development capabilities to get these medicines to patients suffering from autoimmune diseases."

Under the terms of the agreement, Lilly will pay Dice $48 per share in cash, representing a premium of about 40% to the company’s 30-day volume-weighted average trading price.

The transaction is not subject to any financing condition and is expected to close in the third quarter of this year, subject to customary closing conditions.

Patrik Jonsson, executive vice president, president of Lilly Immunology and Lilly US, chief customer officer, said: "In combination with its novel technology and expertise in drug discovery, Dice's talented workforce and passion for innovation will enhance our efforts to make life better for people living with devastating autoimmune diseases.

"We welcome DICE colleagues to Lilly and, together, we can tackle the challenges ahead in finding new treatments for patients with significant unmet medical needs."

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Pharma necesita crecer...y busca como

 

 

 

 

Evitar caida de ventas por pérdida de patentes...

 

 

Mergers and...Los m,ercados "se mueven"...selectivamente.

 

 

Merck – known as MSD outside the US and Canada – has said it will acquire Prometheus Biosciences for around $10.8bn, marking a significant boost to its immunology pipeline.

The deal will grant Merck access to the California-based biotech’s lead candidate, PRA023, being developed for ulcerative colitis, Crohn’s disease and other autoimmune conditions.

Prometheus announced positive results from a phase 2 study of the candidate in ulcerative colitis late last year, with 26.5% of patients in the PRA023 cohort achieving clinical remission, compared to 1.5% on placebo.

The company also reported positive results from a single-arm study evaluating the antibody in Crohn’s disease at the same time.

Commenting on the deal, Robert Davis, chairman and chief executive officer of Merck, said: “The agreement with Prometheus will accelerate our growing presence in immunology where there remains substantial unmet patient need.”

“This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade,” he added.

Under the terms of the agreement, Merck will pay $200 per share. The transaction is expected to close in the third quarter of 2023.

 

GSK has said it will acquire Bellus Health for approximately $2bn in a deal that is set to expand the British drugmaker’s specialty medicines and respiratory pipeline.

The acquisition will grant GSK access to the Canadian biotech’s experimental drug, camlipixant, currently in phase 3 development for refractory chronic cough (RCC).

Current clinical data shows that by selectively inhibiting P2X3 receptors, camlipixant may reduce cough frequency with a relatively low incidence of dysgeusia – the taste disturbance associated with other medicines that broadly target the P2X2/3 receptor.

Bellus initiated a pair of phase 3 trials evaluating camlipixant in recent months, with data from the studies expected in the second half of 2024 and 2025.

Under the terms of the agreement, GSK will pay $14.75 per share in cash. The transaction is expected to close in the third quarter of this year.

Camlipixant is up against a rival RCC candidate, gefapixant, from Merck – known as MSD outside the US and Canada. The drug, which is also a P2X3 receptor antagonist, was denied US approval at the beginning of 2022, with the US Food and Drug Administration requesting additional efficacy information. Merck is expected to submit the information later this year.

Eli Lilly will sell its severe hypoglycaemia treatment, Baqsimi, to Amphastar Pharmaceuticals in a deal worth over $1bn, the two companies announced.

Under the terms of the definitive agreement, Amphastar will pay Lilly $500m at closing and an additional $125m after one year, with Lilly also eligible to receive sales-based milestone payments of up to $450m.

Baqsimi is the first and only nasally administered glucagon that can be used to treat severe hypoglycaemia – very low blood sugar – in diabetes patients aged four years and older.

Classed as a diabetic emergency, severe hypoglycaemia is a complication that can occur in diabetes patients who take insulin and certain anti-diabetic tablets.

The condition is characterised by altered mental or physical functioning, including confusion and disorientation, convulsions, loss of consciousness and coma.

Lilly launched Baqsimi in 2019 and it is currently available in 27 international markets, with worldwide sales totalling over $139m in 2022.

Amphastar, which is focused on developing, manufacturing and marketing injectable, intranasal and inhalation products, said it expects to provide ‘dedicated commercial investment’ to expand access to the treatment.

The transaction has been approved by the boards of directors of both companies and is expected to close in the second or third quarter of 2023.

Pharmaceutical Market Europe May 2023

M&A: NOVARTIS buys CHINOOK

 

Swiss pharma giant Novartis announced that it will acquire kidney disease drug developer Chinook Therapeutics . The target rallied on the news, as a major takeover premium is being paid, but the deal could also make sense for Novartis, as this boosts its pipeline, which should improve the long-term growth outlook.

Novartis, one of the largest pharma companies in the world, announced that it will acquire Chinook Therapeutics in a deal that values the target at $3.5 billion. At the time of writing, Chinook Therapeutics is up 58%, which can be attributed to the fact that Novartis offered a hefty takeover premium of more than 60%. Chinook is still trading slightly below the $40 takeover price, despite the jump its shares have experienced on the takeover news.

On top of the $40 per share, Novartis could pay up to $4 per share over the coming years, depending on whether Chinook will achieve a range of goals. This includes development milestones for Chinook's most important asset atrasentan.

While the deal is huge news for shareholders of Chinook Therapeutics, the $3.5 billion deal price is not overly large for Novartis - the company generated more than $13 billion of free cash flow over the last four quarters, meaning the takeover can be paid for with around three months' worth of NVS' free cash generation. Not surprisingly, Novartis does not need to issue any equity to finance this deal, thus there's no dilution investors have to worry about. In fact, Novartis ended the last quarter with around $15 billion in cash and equivalents, thus the company could pay for several deals of this size in a short period of time.

The Chinook Takeover Boosts Novartis' Pipeline

Novartis is one of the largest pharma companies in the world, thus it naturally is active in different therapeutic areas. It also owns a deep pipeline with a wide range of drug candidates. Some of these are new developments, in other cases, Novartis seeks to get drugs approved for additional indications while already selling the same drug in other indications.

Novartis' pipeline includes candidates in areas such as solid tumors, hematology, immunology, neuroscience, and many more. In total, the company has 48 phase III studies in place right now, as can be seen on its website here. A pharma company with a large and established business such as Novartis needs a deep pipeline, of course, as existing drugs that have been on the market for years go off patent from time to time. 

While sales for off-patent drugs do not drop to zero immediately, they generally decline over time, thus these revenues have to be replaced via a combination of the following factors:

- Increasing the price of its products, thereby generating higher revenue per patient.

- Increasing the number of patients on the company's medication for existing products, e.g. by increased marketing spending or by entering new geographic markets.

- Adding new product lines, either via the introduction of new drugs or by receiving approvals for existing drugs in additional indications.

The last point is highly important, and M&A helps. While Novartis would sport a sizeable pipeline even without any takeovers, M&A can add to a company's growth potential. Importantly, pharma companies also can use M&A in order to boost their presence in markets that are deemed attractive (by the company's management), but where the company's in-house expertise is lacking or where its own development efforts have not resulted in attractive products.

Chinook Therapeutics is focused on kidney diseases, which is not a huge therapeutic area for Novartis yet. In recent years, Novartis generated the vast majority of its revenue and profit in other areas. The company's most recent quarterly report includes the following statement (emphasis by author):

We have a clear focus on five core therapeutic areas

_cardiovascular,

 _immunology, 

_neuroscience, 

_solid tumors and 

_hematology), 

with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential.

Novartis thus has not had a big presence in Chinook Therapeutics' focus area so far, but it looks like management deems this an attractive market to expand into. Precedence Research reports that the global nephrology (kidney disease) market size was $16 billion last year, and it forecasts that this market will grow at a mid-single-digit rate through the early 2030s. This is thus a sizable market with considerable growth over the next decade, although it should be noted that sales forecasts may turn out too high or too low eventually. Still, it seems highly likely to me that the global nephrology market will expand considerably in the long run - aging populations in many industrial countries will result in rising overall healthcare spending, and at the same time, more and more people in high-growth markets such as China and India can afford effective treatments for themselves.

Chinook Therapeutics does not have any drugs on the market so far, but that holds true for many smaller pharma companies. A major pharma company taking over a development-stage pharma company is relatively common, and it makes sense for both parties: The acquirer gets an attractive pipeline asset without spending gigantic sums of money - just a couple of months' worth of cash flow in this case. At the same time, the acquired company benefits from increased funding and the acquirer's expertise when it comes to the regulatory process, and, eventually, commercialization of the drug once approved. A global giant such as Novartis can leverage the sales potential of a drug (once approved) a lot faster and more efficiently compared to a small pharma company that has not established itself globally yet. Such deals thus oftentimes make sense for both involved parties, although there is, of course, still some risk for the acquirer - it's possible that the acquired company's pipeline assets turn out to not perform as well as expected, and in a worst-case scenario, no drug will be approved. The good news is that this would still be easily stomached for a company such as Novartis - the worst-case scenario of spending $3.5 billion without getting any new drug out of this deal is not a company-threatening event at all.

Chinook Therapeutics' lead agent, atrasentan, is being evaluated for the treatment of IgA Nephropathy. There are competing drugs on the market, such as Calliditas Therapeutics' Tarpeyo, which was the first IgAN treatment to receive approval in the US. But since Tarpeyo was approved not too long ago, it's not too late to enter this market with a new drug. It's expected that this market will expand significantly in the coming years, and it seems likely that more than one company can make money selling an IgAN treatment. With NVS' global presence and established wide sales network, commercializing atrasentan would not be too hard - if the drug candidate performs well and receives approvals.

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