Tirzepatide Archives | Aspen Pharmacare /tag/tirzepatide/ Fri, 20 Dec 2024 08:02:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 /wp-content/uploads/2022/07/favicon-150x150.png Tirzepatide Archives | Aspen Pharmacare /tag/tirzepatide/ 32 32 ĚÇĐÄvlog announces local availability of Lilly’s Mounjaro /aspen-announces-local-availability-of-lillys-mounjaro/ Fri, 20 Dec 2024 08:02:47 +0000 /?p=15541 Aspen has announced the availability of Lilly's tirzepatide, marketed globally as Mounjaro®, a therapeutic option available to physicians for the treatment of Type II diabetes.

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Johannesburg – JSE-listed Aspen Pharmacare Holdings Limited (“Aspen”), a global multinational specialty pharmaceutical company, earlier today announced the local availability of Eli Lilly’s (“Lilly”) tirzepatide, marketed globally as Mounjaro®.

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Mounjaro® is a once-weekly glucose-dependent insulinotropic polypeptide (“GIP”) receptor and glucagon-like peptide-1 (“GLP-1”) receptor agonist, used as an adjunct to diet and exercise to treat adults with insufficiently controlled Type II diabetes, which has been approved by the South African Health Products Regulatory Authority (“SAHPRA”).

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On 30 August 2023, ĚÇĐÄvlog announced that it had entered into a distribution and promotion agreement with Lilly to extend access to Lilly’s innovative portfolio of medicines to patients in South Africa and the rest of Sub-Saharan Africa.

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Stephen Saad, Aspen Group Chief Executive said, “Aspen values our relationship with Lilly and its recognition of ĚÇĐÄvlog as its chosen partner in Southern Africa to assist in contributing towards arresting non-communicable diseases (“NCDs”) which include cardiovascular diseases, cancer and diabetes. Tirzepatide is one of the therapeutic options available to physicians for the treatment of Type II diabetes, which has doubled in recent times [1], with one in two diabetic patients in South Africa being undiagnosed [2]. A strong link is evident between diabetes, heart disease and obesity which triggers the metabolic-cardio-renal complex [3] and which poses a significant financial and public health threat to an already over-burdened healthcare system, impacting lives and livelihoods. Tirzepatide represents an added therapeutic option to address the rising tide of NCDs. It will increase access and can significantly improve related health outcomes.”

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Tirzepatide will be available in South Africa during the latter part of December 2024 in single-dose vials, with a KwikPen® presentation currently under evaluation at SAHPRA.

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[1] Stats SA. Non-Communicable diseases in South Africa: Findings from death notifications 2008 – 2018.

Available at: (Accessed 19 December 2024).

[2] IDF (2019) Diabetes Atlas – Ninth edition 2019, International Diabetes Federation. Available at: https://www.diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf (Accessed: 12 November 2024).

[3] Usman MS, Khan MS, Butler J. The Interplay Between Diabetes, Cardiovascular Disease, and kidney disease. 2021 Jun. In: Chronic Kidney Disease and Type 2 Diabetes. Arlington (VA): American Diabetes Association; 2021 Jun. Available from: https://www.ncbi.nlm.nih.gov/books/NBK571718/ doi: 10.2337/db20211-13

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ĚÇĐÄvlog announces additional pharmaceutical donations for Ukranian patients /aspen-announces-additional-pharmaceutical-donations-for-ukranian-patients/ Mon, 25 Mar 2024 10:10:04 +0000 /?p=15042 Ěý Johannesburg, South Africa – Aspen Pharmacare, Africa’s largest pharmaceutical company, has announced continued humanitarian support to Ukraine, confirming further donations of critical care products to treat hospitalized patients who have been impacted by the ongoing conflict in that country. Ěý Stavros Nicolaou, Aspen Group Senior Executive Strategic Trade, said, “Aspen is highly sensitised to… Continue reading ĚÇĐÄvlog announces additional pharmaceutical donations for Ukranian patients

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Johannesburg, South Africa – Aspen Pharmacare, Africa’s largest pharmaceutical company, has announced continued humanitarian support to Ukraine, confirming further donations of critical care products to treat hospitalized patients who have been impacted by the ongoing conflict in that country.

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Stavros Nicolaou, Aspen Group Senior Executive Strategic Trade, said, “Aspen is highly sensitised to the human suffering that war and conflict brings and which has had a devastating impact on innocent civilians. We are pleased to announce that we are further extending our support to Ukrainian victims of the present-day conflict with much needed pharmaceutical products and we are in the process of despatching additional supplies of Fraxiparine (for emergency surgeries) and Alkeran (for cancer) to treat patients in Ukrainian hospitals. We remain committed to providing ongoing humanitarian relief to victims of both natural and manmade disasters as may be necessary.”

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Aspen recently hosted His Excellency, former President of the Ukraine, Viktor Yushchenko during an official visit to South Africa. On this occasion he said, “I am deeply grateful to Aspen for the invaluable humanitarian support provided to the people of Ukraine at this very tragic time. Aspen has helped countless Ukrainians with generous donations of life-saving critical care medicines. Aspen’s ongoing support reaffirms their understanding of the horrors of war, and demonstrates their unwavering care for innocent patients who are in desperate need of pharmaceutical products. I thank Aspen for their contributions to date as well as their commitment toĚý providing more products to treat our patients.”Ěý

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One of the more important initiatives in this humanitarian collaboration with Her Excellency Ambassador and Plenipotentiary of Ukraine to South Africa, Liubov Abravoitova, concerns donations of Alkeran primarily used for the treatment of paediatric cancer patients at the Odessa Filatov Institute of Ophthalmology. She said, “We thank Aspen for its solidarity with Ukrainian people and support to Ukraine with donations of life-saving medicines, as well as for its cooperation with the Embassy of Ukraine in South African in humanitarian projects.” Aspen’s latest Alkeran donation has been expedited specifically to assist in the treatment of a six year old patient who is at risk of losing her only eye.

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In March 2022 Aspen dontated life-saving medicines for 62Ěý000 surgeries in Ukraine and also helped to evacuate South African medical students who were stranded in war-torn Ukraine.

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Aspen building momentum with revenue up 10% to R21,1Ěýbillion /aspen-building-momentum-with-revenue-up-10-to-r211-billion/ Mon, 04 Mar 2024 10:51:00 +0000 /?p=15000 Johannesburg – JSE-listed Aspen Pharmacare Holdings Limited (APN), a global multinational specialty pharmaceutical company, has reported solid unaudited interim Group financial results for the six months ended 31 December 2023. SALIENT HIGHLIGHTS Revenue increased by 10% (2% in constant exchange rate (“CER”)) to R21,1 billion (December 2022: R19,2 billion) Normalised EBITDA increased by 2% (-5%… Continue reading Aspen building momentum with revenue up 10% to R21,1Ěýbillion

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Johannesburg – JSE-listed Aspen Pharmacare Holdings Limited (APN), a global multinational specialty pharmaceutical company, has reported solid unaudited interim Group financial results for the six months ended 31 December 2023.

SALIENT HIGHLIGHTS
  • Revenue increased by 10% (2% in constant exchange rate (“CER”)) to R21,1 billion (December 2022: R19,2 billion)
  • Normalised EBITDA increased by 2% (-5% in CER) to R5,2 billion (December 2022: R5,1 billion)
  • Normalised headline earnings per share increased by 1% (-5% in CER) to 688,3 cents (December 2022: 679,6 cents)
  • Headline earnings per share decreased by 6% (-12% in CER) to 620,7 cents (December 2022: 660,6 cents)
  • Earnings per share decreased by 13% (-18% in CER) to 520,8 cents (December 2022: 602,0 cents)
  • Operating cash flow per share increased by 44% to 553,2 cents (December 2022: 384,3 cents)

Stephen Saad, Aspen Group Chief Executive said, “Great progress has been made in delivering on our ambitious strategy to lay the foundation for strong growth. We have successfully completed the necessary steps to reach the commercialisation stage for the manufacture of mRNA platform products which will augment revenue in H2 2024. Notable financial highlights include a 10% increase in revenue and a 44% increase in operating cash flow per share. The transition to new toll manufacturing agreements for the Heparin business is expected to reduce inventory investment by R3 billion by the end of the financial year. Organic growth complemented by acquisitions is set to drive Commercial Pharmaceuticals’ revenue in H2 2024 up by some R1 billion over H2 2023. We are also pleased to report that our recently announced acquisition of products in China, which remain subject to Competition Authority approval, will mitigate the negative volume-based procurement impact from FY2025.”

Noteworthy achievements in this half include, inter alia, the following:

Sterile manufacturing contract for mRNA filling reaches commercialisation stage
Successful completion of the required trial and validation batches has resulted in the fulfillment of the suspensive conditions to the previously disclosed agreement for the manufacture of mRNA platform products. The commercialisation of this opportunity will benefit revenue and contribution in the last quarter of H2 2024. The impact of the volume ramp up and its annualisation will be materially higher from FY2025 onwards.

Heparin business transitions to a toll manufacturing model
Manufacturing agreements for the supply of heparin-based syringes are transitioning to a toll contract manufacturing arrangement. The heparin active pharmaceutical ingredient (“API”) will now be owned by the customers. This will reduce Aspen’s investment in heparin inventory and increase operating cash flows in both FY2024 and FY2025. In H1 2024, Aspen’s investment in heparin inventory reduced by R1 billion with a further R2 billion reduction anticipated by the end of June 2024.

China volume-based procurement (“VBP”) mitigation strategy well on track
ĚÇĐÄvlog announced that it had concluded agreements with Sandoz AG (“Sandoz”), including acquiring the Sandoz business in China. The net upfront consideration is EUR27.9 million followed by potential net milestone payments of EUR9.2 million. Approval for the transaction from the Competition Authority in China is anticipated in May 2024. The transaction will materially mitigate the negative impact of VBP on Aspen’s existing business in China on an annualised basis from FY2025.

Commercial Pharmaceuticals portfolio enhancement strategy set to drive strong growth in H2 2024 revenue
H2 2024 will be boosted by the distribution and promotion agreement with Lilly for sub–Saharan Africa and the product purchase agreement with Viatris for Latin America. The agreement with Lilly is effective from January 2024. Subsequent years will benefit from the launch of key pipeline products including Lilly’s Tirzepatide, marketed globally as Mounjaro®. Viagra, Lipitor, Norvasc, Lyrica and Celebrex are key brands included in the product portfolio acquired for Latin America.

GROUP HIGHLIGHTS
1The Group assesses its operational performance using constant exchange rate (“CER”). The table above compares performance to the prior comparable period at reported exchange rates and at CER.
2 The CER % change is based upon the performance for the six months ended 31 December 2022 recalculated using the average exchange rates for six months ended 31 December 2023.
3Operating profit before depreciation and amortisation adjusted for specific non-trading items as defined in the Group’s accounting policy.
4ĚýNormalised headline earnings per share (“NHEPS”) represents headlines earnings per share (“HEPS”) adjusted for specific non-trading items as defined in the Group’s accounting policy.

GROUP PERFORMANCE
The Group has exceeded its guided performance growing normalised EBITDA ahead of H1 2023 and overcoming the negative impact of VBP in China as well as the loss of grant funding which benefitted the prior period.

Group revenue for the six months ended 31 December 2023 grew 10% (2% CER) to R21 141 million, with Commercial Pharmaceuticals revenue up 3% (-3% CER) and Manufacturing revenue increasing by 33% (17% CER). Group gross profit grew 4% (-3% CER) muted by an increased Manufacturing sales mix. Normalised EBITDA rose 2% (-5% CER) to R5 194 million. Elevated transaction costs primarily relating to acquisitions, together with increased intangible asset impairments due to the VBP impact in China, resulted in operating profit declining.

Normalised net financing costs of R566 million were 3% (-10% CER) lower than the prior year. Increased net interest costs, fueled by higher rates, were more than offset by lower foreign exchange losses resulting from reduced volatility in emerging market currencies relative to the Euro. NHEPS advanced 1% (-5% CER) aided by the lower net financing costs. Financing costs in H2 2024 will continue to be influenced by the interest rate cycle and emerging market foreign currency volatility. HEPS declined by 6% (-12% CER) and earnings per share ended 13% lower (-18% CER) affected by the higher transaction costs and intangible asset impairments respectively.

SEGMENTAL PERFORMANCE
Commercial Pharmaceuticals
Aspen has revised and refined its reportable segments to align to the Group’s Commercial Pharmaceuticals growth strategy. The new segments comprise Prescription, Over-the-counter (“OTC”) and Injectables which have been defined in the basis of accounting section of the financial results.

Commercial Pharmaceuticals revenue grew by 3% (CER -3%) to R 15Ěý029 million underpinned by organic growth in OTC and Prescription offset by a decline in Injectables revenue. Gross profit margins remained consistent at 59.8% (H1 2023: 60.0%).

Prescription
Prescription Brands recorded revenue of R5Ěý306 million enjoying steady momentum of 7% (CER 1%) aided by growth in its largest region, Africa Middle East, and the Americas. Australasia, the second largest region in this segment, was adversely impacted by further regulated price reductions.

Gross profit percentage was up at 61.6% (H1 2023: 60.7%) augmented by a favourable sales mix, which more than offset the regulated price cuts in Australia.

OTC
OTC, the second largest segment in Commercial Pharmaceuticals, grew revenue by 10% (CER 4%) to R4 893 million with all regions reporting solid growth. Gross profit percentage of 58.8% remained in line with the prior year of 58.6%.

Injectables
This segment was heavily impacted by further VBP in China and the reduction in demand in Russia CIS. Strong hormonal injectable brand growth in the Americas (most notably Brazil) partly mitigated the overall segment sales reduction which recorded a revenue decline of 6% (CER -12%) to R4Ěý830 million.

Gross profit percentage declined to 58.9% (H1: 2023 60.5%) influenced by the impact of VBP, partly offset by further cost of goods savings from insourcing sterile production.

Manufacturing
Manufacturing revenue grew significantly, increasing 33% (CER 17%) partly aided by exchange rate tailwinds. API, the largest and most profitable segment in Manufacturing, rebounded strongly in H1 2024 with revenue growing by 18% (CER 4%). Finished Dose Form (“FDF”) revenue increased by 10% (CER -2%) impacted by the loss of final COVID vaccine sales included in the previous year. Heparin incremental revenue growth of R957 million over the comparable period was augmented by the transition to toll manufacture. Following this transition the Heparin segment which previously included the full value chain contribution from all heparin containing products being APIs and FDF sales, will now include heparin API sales only.

Gross profit percentage was in line with the prior year at 5.3% (H1 2023: 5.2%) with the loss of grant funding being offset by a strong performance from API, the benefit of additional Heparin sales and the delay to the second half of FY2024 of a technical shutdown at the Group’s French facility.

PROSPECTS
The Group has achieved results in the first half which were well aligned to guidance provided.

H2 2024 is the start of the journey to both realising the tangible benefits from sterile manufacturing investments and delivering a predictable growing base Commercial Pharmaceuticals business that has managed and successfully absorbed the VBP risks faced in China.

Based upon current exchange rates, and notwithstanding the impact of VBP in China and the loss of grant funding of USD30 million which benefitted the prior year, we anticipate mid-single digit reported growth in normalised EBITDA for FY2024. The targeted growth is underpinned by expected reported revenue growth in both Commercial Pharmaceuticals and Manufacturing.

For Commercial Pharmaceuticals, we expect the H1 2024 revenue increase to be boosted by an additional R1 billion in revenue growth targeted for H2 2024 over H2 2023. This growth will be driven organically and complemented by the inclusion of portfolio acquisitions in South Africa and Latin America partly offset by the impact of VBP in China, including the addition of Diprivan in the latest round. Manufacturing is poised to enjoy a strong second half supported by the expected contribution of R500 million flowing from the initiation of sterile contracts and a seasonally stronger performance from the API business.

We expect manufacturing inventory levels to reduce in H2 2024 as the Heparin business fully transitions to a working capital light toll manufacturing model. The lower anticipated working capital cash flow investment compared to FY2023 should assist us in achieving an operating cash conversion rate greater than our target of 100%.

During H2 2024, we will be looking to close out further opportunities, currently under discussion or diligence, to more fully utilise our available sterile capacities. We remain confident in achieving the guided contributions of at least R3 billion in FY2025 increasing to no less than R4 billion in FY2026. These contributions, together with a de-risked Commercial Pharmaceuticals’ base business will form the cornerstone for strong organic revenue and earnings growth into the future.

Any forecast information in the above-mentioned paragraphs has not been reviewed or reported on by the Group’s auditors and is the responsibility of the directors.

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