Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi’s 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore’s HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management team will host one-on-one meetings at both conferences. Alvotech will also hold a fire-side chat at Evercore’s HealthCONx Conference on T ...

REYKJAVIK, Iceland, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference, November 19-20, 2024. Members of the management team will host one-on-one meetings on both days. Alvotech will be presenting at the conference on Tuesday, November 19, 2024 at 9:00-9:25 am GMT. An audio webcast of the conference pr ...

Core Viewpoint - The FDA has approved SELARSDI (ustekinumab-aekn) in a new intravenous formulation, expanding its indications to include treatment for adults with Crohn's disease and ulcerative colitis, with a U.S. launch expected in Q1 2025 [1][2] Group 1: Product Approval and Launch - SELARSDI 130 mg/26 mL has been approved for intravenous infusion, aligning its label with the reference product Stelara® [1] - The U.S. launch of SELARSDI for all indications is anticipated in the first quarter of 2025 [1] - Previous approvals include SELARSDI 45 mg/0.5 mL and 90 mg/mL for subcutaneous injection, approved in April 2024 for moderate to severe plaque psoriasis and active psoriatic arthritis [2] Group 2: Company Statements and Strategic Goals - Alvotech's CEO expressed commitment to aligning SELARSDI's label with the reference product before the launch, highlighting successful launches in Canada, Japan, and Europe [2] - Teva's Senior VP noted the expansion of SELARSDI's indications as a significant milestone in increasing access to biosimilars in the U.S. [2] - The partnership between Alvotech and Teva has expanded to include nine products, with a focus on increasing the availability of biosimilars [4] Group 3: Product Development and Technology - Alvotech developed SELARSDI using Sp2/0 cells and a continuous perfusion process, similar to the production of Stelara [3] - Ustekinumab, the active ingredient in SELARSDI, targets the p40 protein, crucial for treating immune-mediated diseases [3][6] Group 4: Market Context and Competitive Landscape - Alvotech aims to be a global leader in the biosimilar market, with a pipeline that includes nine candidates targeting various diseases [8] - The strategic partnership with Teva leverages their extensive sales and marketing infrastructure for commercialization in the U.S. [4][10]

Core Insights - Alvotech has initiated a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab), which aims to demonstrate its comparative efficacy, safety, and immunogenicity in patients with moderate to severe active Ulcerative Colitis [1][2][3] - Entyvio generated approximately $5.4 billion in global sales over the last 12 months up to June 30, 2024, indicating a significant market opportunity for biosimilars [1][2] - Alvotech's current biosimilars portfolio includes treatments for autoimmune diseases, eye disorders, bone diseases, respiratory diseases, and cancer, with two biosimilars already approved and marketed [3][8] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, with a commitment to increasing access to cost-effective biologic treatments [2][8] - The company has a pipeline that includes nine disclosed biosimilar candidates, targeting various diseases, and plans to file marketing applications for three candidates in 2024 [3][8] - Alvotech has established strategic partnerships for global reach, including collaborations with Teva Pharmaceuticals and other companies across multiple regions [8]

REYKJAVIK, Iceland, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Members of the management team will hold an in-person fireside chat on September 5, 2024, starting at 5:35 pm EDT (21:35 GMT). A live audio webcast of the fireside chat will be available and can be accessed ei ...

iQoncept Investment Overview - Recap on Alvotech My last coverage of Alvotech (NASDAQ:ALVO) for Seeking Alpha was back in April, a few weeks before the biosimilar medicine specialist announced its Q1 2024 earnings. I gave its stock a "Buy" rating, concluding that: if you are an investor looking to gain exposure to the biosimilar industry today, Alvotech represents one of your better options, in my view. It is cheaper to own a chunk of Alvotech than most other generic drug manufacturer's I can think of - Te ...

Financial Data and Key Metrics Changes - Total revenues for the first half of 2024 were $236 million, a tenfold increase compared to $20 million in the same period of 2023 [37] - In Q2 2024, total revenues reached $199 million, up from $4 million in Q2 2023 [37] - Adjusted EBITDA for the first half of 2024 was $64 million, compared to negative $147 million in the same period of 2023 [43] - Operating profit was $43 million for the first half of 2024, a significant improvement from negative $189 million in the prior year [42] Business Line Data and Key Metrics Changes - The company recognized $145 million in milestone revenues and $54 million in product revenues during Q2 2024, marking the highest figures reported to date [37] - The order book for the US market for the biosimilar to Humira has reached approximately 1.3 million units for 2024, with expectations to deliver over 80% in the second half of the year [9][22] - The company expects to submit three biosimilar applications in major markets by the end of 2024, with anticipated revenues starting as early as the end of 2025 [12] Market Data and Key Metrics Changes - The company launched its biosimilar to Stelara in Canada and Japan, with no competition expected in these markets [23] - The US market is seeing a transition to biosimilars, with approximately 20% of Cigna's book transitioning to biosimilars within five weeks of launch [18] - The company anticipates multiple pharmacy benefit products on the market by the end of 2025, enhancing its market position [19] Company Strategy and Development Direction - Alvotech is focused on a global portfolio approach to biosimilars, aiming for at least 70 global launches by the end of 2025 [12] - The company is committed to developing and manufacturing biosimilars exclusively, leveraging its world-class facility for future earnings [14] - The strategic partnership with Teva is crucial for advancing multiple products in the US specialty channels [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing a strong order book and favorable market conditions for biosimilars [56] - The company expects Q3 to show strong volume growth, with Q4 anticipated to be the strongest quarter of the year in terms of sold volumes [9] - Management highlighted the importance of operational execution to maximize the potential of upcoming product launches [46] Other Important Information - The company successfully refinanced its outstanding debt, reducing the cost of capital by approximately 100 basis points and extending maturities to 2029 [35] - The net impact of the refinancing added approximately $142 million of net cash to the balance sheet, simplifying the borrowing structure [36] Q&A Session Summary Question: What is the outstanding potential milestone revenue from existing partnerships? - The company has over $1 billion of milestones yet to be collected from current agreements [49] Question: What progression should be expected for gross profit margin on product sales? - Product margins were around 17% in Q2, with expectations for continued quarter-over-quarter increases driven by higher volumes and product mix [51] Question: Could you elaborate on the success of the commercial launch in the US for SIMLANDI? - The company is well-positioned with a strong product profile and a sizable order book, expecting continued growth and expansion in the market [55]

Q2 2024 Earnings AUGUST 16, 2024 Disclaimer This presentation ("Presentation") does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Alvotech (the "Company") to any person in the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Any trademarks, servicemarks, trade names and copyrights of the Company and other companies contained in this Presentation are the property of their respectiv ...

Record Total Revenues of $236 million for the first six months of 2024, an over ten-fold increase compared to same period in 2023Product revenues for the first six months were $66 million, a 190% increase from the same period last year, with Q2 product revenues contributing $53 millionLicense and other revenues for the first six months increased to $170 million, with Q2 license and other revenues contributing $145 millionAdjusted EBITDA in the first six months was $64 million, compared to negative ($147) mi ...

Financial Performance - Product revenue for the six months ended June 30, 2024, was $65.9 million, a significant increase from $22.7 million for the same period in 2023[7]. - License and other revenue rose to $169.7 million for the six months ended June 30, 2024, compared to a loss of $2.5 million in the same period of 2023, driven by multiple R&D milestones[8]. - Operating profit for the six months ended June 30, 2024, was $43,447 thousand, a turnaround from an operating loss of $189,101 thousand in the prior year[28]. - The Group's revenue for the six months ended 30 June 2024 was $235.6 million, a significant increase from $20.3 million in the same period of 2023[53]. - Product revenue recognized in 2024 was $65.9 million, compared to $22.7 million in 2023, while license revenue surged to $68.1 million from $7.6 million[53]. - The total comprehensive loss for the six months ended June 30, 2024, was $153.4 million, reflecting the company's ongoing operational challenges[44]. Expenses and Losses - Research and development expenses decreased slightly to $97.5 million for the six months ended June 30, 2024, from $99.6 million in the same period of 2023[11]. - General and administrative expenses were reduced to $29.6 million for the six months ended June 30, 2024, down from $41.9 million in the same period of 2023[12]. - The net loss for the six months ended June 30, 2024, was $153.5 million, or $(0.61) per share, compared to a net loss of $86.6 million, or $(0.39) per share, for the same period in 2023[12]. - The company reported a loss for the period of $(153,504) thousand for the first half of 2024, compared to a loss of $(86,854) thousand in the same period of 2023[28]. - For the six months ended June 30, 2024, the company reported a net loss of $153.5 million, compared to a net loss of $86.9 million for the same period in 2023, reflecting an increase in losses of approximately 76.7%[44]. Cash and Borrowings - As of June 30, 2024, Alvotech had $10.9 million in cash and cash equivalents and borrowings of $1,055.9 million, including $999.0 million in current borrowings[7]. - The company entered into a $965 million Facility in June 2024 to improve capital costs and address upcoming debt maturities[17]. - The Group's total outstanding borrowings increased to $1,055,913 million as of June 30, 2024, compared to $960,159 million at the end of 2023, reflecting a 10% increase[83]. - Cash used in operating activities was $(126,000) thousand for the six months ended June 30, 2024, slightly improved from $(128,002) thousand in the same period of 2023[37]. - The company had cash and cash equivalents of $10.9 million as of June 30, 2024, with current assets less current liabilities amounting to ($917.3) million[44]. Assets and Equity - Total assets increased to $1,068,478 thousand as of June 30, 2024, up from $950,090 thousand at the end of 2023, reflecting a growth of approximately 12.4%[31]. - The total equity position improved to $(605,922) thousand as of June 30, 2024, compared to $(932,493) thousand at the end of 2023, indicating a reduction in accumulated deficit[34]. - The accumulated deficit reached $2,359.3 million, up from $2,205.8 million as of December 31, 2023, indicating ongoing financial challenges[44]. Share Issuance and Financing - Alvotech issued approximately 22.1 million new shares on July 1, 2024, corresponding to approximately $221.1 million from the conversion of 2022 Convertible Bonds[20]. - The company recognized a capital contribution of $144.6 million during the first half of 2024, contributing to its equity position[44]. - The Group issued approximately 22.1 million new shares from the conversion of 2022 Convertible Bonds, corresponding to an aggregate value of approximately $221.1 million[50]. Regulatory Approvals and Collaborations - Alvotech's AVT04 biosimilar to Stelara received FDA approval in April 2024, with commercialization expected to start on or after February 21, 2025[13]. - The company announced a collaboration with Dr. Reddy's Laboratories for the commercialization of AVT03, a biosimilar candidate to Prolia and Xgeva, with exclusive rights in the U.S.[45]. - The FDA also approved SIMLANDI, an interchangeable biosimilar to Humira, which had U.S. sales of nearly $12.2 billion in 2023[49]. Inventory and Costs - The Group's inventory balance increased to $96,574 million as of June 30, 2024, up from $74,433 million at the end of 2023, representing a 30% increase[77]. - The Group recognized $32.0 million in cost of inventory within cost of goods sold during H1 2024, compared to $16.5 million in H1 2023, indicating a 94% increase[76]. Financial Ratios and Tax - The effective tax rate for the six months ended 30 June 2024 was (3.5)%, compared to 36.5% in the same period of 2023, reflecting a tax charge and a tax benefit, respectively[60]. - The weighted-average interest rate of outstanding borrowings was 12.80% for H1 2024, slightly up from 12.73% for the twelve months ended 31 December 2023[82].