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Hikma Pharmaceuticals Reiterates 2026 Guidance, Exits 503B Compounding in April Trading Update Call

Hikma Pharmaceuticals logo with Medical background
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Key Points

  • Reiterated 2026 guidance: Hikma said it has made an "encouraging start" to 2026, is performing in line with expectations, and expects group revenue to be more second-half weighted while profit will be more evenly split across the year.
  • Exit of 503B compounding: Hikma will exit the 503B compounding business and intends to sell the associated facility, noting the business was "very immaterial" (under $15 million) and should have an immaterial impact on 2026.
  • Injectables and pipeline focus: Management is prioritizing injectables with agility improvements, hires and capacity expansions in the U.S. and Saudi Arabia; TYZAVAN is ramping (H2-weighted) and Hikma plans a U.S. nasal epinephrine filing in 2026 with European filings in H1 2026.
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Hikma Pharmaceuticals LON: HIK said it has made an “encouraging start” to 2026 and reiterated its full-year group guidance, citing performance across all three of its businesses and continued robust demand in core markets, according to remarks on the company’s April trading update call.

Chief Executive Officer Said Darwazah told analysts the group is “performing in line with our expectations,” adding that organizational changes made toward the end of last year are “having the intended effect” as the company focuses on three priorities he outlined earlier in the year: agility, stability, and investment.

Guidance reiterated; revenue expected to be more second-half weighted

During the Q&A, management said it expects group revenue to be weighted more toward the second half of the year, consistent with prior years, while profit is expected to be more evenly split between the halves. Management also provided directional phasing by segment.

  • Group: revenue more weighted to the second half; profit expected to be “equal.”
  • Injectables: second-half expected to have higher revenues and profits.
  • Branded: expected to be more first-half weighted for revenue and profit.
  • Hikma Rx: expected to be “more equal” across the year.

Company exits 503B compounding business; plans to sell facility

Darbazah said Hikma has decided to exit the 503B compounding business to concentrate on its three core businesses. Deputy CEO for North America and Europe Khalid Nabilsi said Hikma entered compounding in 2021 and that through 2025 it “remained to be small.” He described it as “a different model than our sterile injectable model” that was taking “too much time to grow” and “causing some disruption.”

Nabilsi said the wind-down is intended to allow Hikma to focus resources—“time, efforts, money”—on injectables, and he characterized the impact as “immaterial for 2026.” He added that the compounding revenue is included in the company’s “Others” line rather than injectables and said it was “less than $15 million.”

Asked about the facility associated with the 503B business, Nabilsi said, “The plan is to sell the facility,” adding that there is interest in the site and that Hikma expects a “good price.” Executive Vice Chairman and Deputy CEO for MENA Mazen Darwazah said the business was “very immaterial” to the group and required “a lot of attention, regulatory and others,” noting regulatory changes over the last four to five years.

Management also addressed profitability expectations for the “Other” segment, stating that 503B was at break-even, while “the other segment… will be slightly positive, excluding the 503B.”

Operational focus: injectables agility, talent moves, and capacity expansion

In his prepared remarks, Said Darwazah said Hikma is taking steps in injectables to improve agility, including strengthening the supply chain, reducing bottlenecks, enhancing specialty commercial capabilities and service levels, improving manufacturing flows, and refining R&D priorities to keep them “tightly focused.”

On stability, he highlighted hires and internal promotions across supply chain, commercial, procurement, and quality, and said the company is in the “final stages” of appointing a new head of CMO.

On investment, he said the company is progressing on capacity expansion projects in Bedford and Columbus in the U.S. and in Saudi Arabia, and continues to prioritize R&D investment in “complex and differentiated technologies.”

Product and pipeline updates: TYZAVAN ramp, inhalation device partnership, epinephrine filing plans

Nabilsi said TYZAVAN is “ramping up” and that Hikma is converting customers to its ready-to-use format, with performance expected to be “more H2-weighted.” He added that the ramp is taking time but is “in line with what we have planned at the beginning of the year.”

Hikma also discussed a device partnership supporting its generic Ellipta development program. Nabilsi said the partner is not Vectura and that Hikma is not disclosing the partner’s identity. He described the program as being in an early stage, with execution being expedited and moving according to plan as part of Hikma’s broader inhalation strategy within Hikma Rx.

On nasal epinephrine, Nabilsi said Hikma is planning to file in the U.S. in 2026 and has had “good discussions with the FDA.” He said the company filed in the U.K. last year and plans to file in Europe in the first half of 2026. He also noted a U.S. delay because the FDA asked for clinical studies, which he said would strengthen the filing.

MENA demand, inflation, FX, and biosimilars commentary

On the Middle East, Mazen Darwazah said Hikma operates across 18 markets grouped into clusters, including North Africa (Morocco, Algeria, Tunisia), Egypt, Saudi Arabia, and the Levant, and said the company is “balanced across” the key clusters. He added that Saudi Arabia is the company’s largest market after the U.S. He attributed robust demand in part to governments asking for stockpiling of certain products and supply commitments “up to six months” in some cases.

Management said it is seeing inflationary cost pressures but expects to manage them through branded performance and cost control. On inventory, management said Hikma started the year with “good inventory levels” and experienced teams overseeing API and raw materials levels across the group.

On foreign exchange, management noted depreciation in some North African countries during the outbreak of the conflict but said currencies are stabilizing and that it does not see a big impact. Management also noted that currencies in markets close to the conflict such as GCC countries and Jordan are pegged to the dollar.

On biosimilars, Mazen Darwazah said Hikma is “very active” in biosimilars in MENA, citing its cooperation with Celltrion and alliances, including in oncology biosimilars. He said Hikma is the leading provider of biosimilars in MENA by dollar value. Nabilsi said biosimilars remain a “very small contributor” in the U.S., though the company continues to evaluate opportunities that fit its longer-term strategy.

Closing the call, Said Darwazah said Hikma started the year “on a very good note” and that management feels “very comfortable that we will achieve our targets for this year.”

About Hikma Pharmaceuticals LON: HIK

At Hikma we help put better health within reach, every day. By creating high-quality medicines and making them accessible to the people who need them, we help to shape a healthier world that enriches all our communities. We help deliver this by living our culture, delivering our strategy, and acting responsibly. We are a trusted, reliable partner and dependable source of over 820+ (as of Feb 2026) high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, MENA and Europe.

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