ANI Pharmaceuticals, Inc. Completes Acquisition of Alimera Sciences
ANI Pharmaceuticals (ANIP) has completed its acquisition of Alimera Sciences, strengthening its Rare Disease segment. The deal adds approximately $105 million in 2024 revenue on a pro forma basis and expands ANI's footprint to 20 countries. Key points include:
1. Addition of two commercial assets: ILUVIEN® and YUTIQ® with growth potential in ophthalmology
2. Expected to drive high single-digit to low double-digit accretion in adjusted non-GAAP EPS in 2025
3. New capital structure reducing interest expense by approximately $39 million annually
4. Expansion of Rare Disease segment to ~45% of pro forma 2024 revenues
5. Potential for accelerated growth of Cortrophin Gel in ophthalmology
ANI maintains its 2024 financial guidance for the standalone company based on continued momentum across Purified Cortrophin® Gel and Generics.
ANI Pharmaceuticals (ANIP) ha completato l'acquisizione di Alimera Sciences, rafforzando il suo segmento Malattie Rare. L'accordo aggiunge circa 105 milioni di dollari di fatturato nel 2024 su base pro forma e amplia la presenza di ANI a 20 paesi. I punti chiave includono:
1. Aggiunta di due asset commerciali: ILUVIEN® e YUTIQ® con potenziale di crescita in oftalmologia
2. Si prevede un incremento a singolo e a basso doppio numero nell'EPS rettificato non-GAAP nel 2025
3. Nuova struttura di capitale che riduce il costo degli interessi di circa 39 milioni di dollari all'anno
4. Espansione del segmento Malattie Rare a ~45% delle entrate pro forma 2024
5. Potenziale per una crescita accelerata di Cortrophin Gel in oftalmologia
ANI mantiene le proprie previsioni finanziarie per il 2024 per l'azienda indipendente basate sul continuo slancio di Purified Cortrophin® Gel e Generici.
ANI Pharmaceuticals (ANIP) ha completado la adquisición de Alimera Sciences, fortaleciendo su segmento de Enfermedades Raras. El acuerdo añade aproximadamente 105 millones de dólares en ingresos en 2024 sobre una base pro forma y expande la presencia de ANI a 20 países. Los puntos clave incluyen:
1. Adición de dos activos comerciales: ILUVIEN® y YUTIQ® con potencial de crecimiento en oftalmología
2. Se espera que impulse un aumento de dígitos altos a bajos de dos dígitos en el EPS ajustado no-GAAP en 2025
3. Nueva estructura de capital que reduce los gastos por intereses en aproximadamente 39 millones de dólares anualmente
4. Expansión del segmento de Enfermedades Raras a ~45% de los ingresos pro forma 2024
5. Potencial para un crecimiento acelerado de Cortrophin Gel en oftalmología
ANI mantiene sus proyecciones financieras para 2024 para la empresa independiente basadas en el continuo impulso de Purified Cortrophin® Gel y Genéricos.
ANI Pharmaceuticals (ANIP)는 Alimera Sciences의 인수를 완료하고 희귀 질환 부문을 강화했습니다. 이 거래는 2024년에 약 1억 5천만 달러의 수익을 추가합니다 프로 포르마 기준으로 ANI의 사업 영역을 20개 국가로 확장합니다. 주요 내용은 다음과 같습니다:
1. 두 개의 상업 자산 추가: ILUVIEN® 및 YUTIQ® 안과 분야에서 성장 잠재력
2. 2025년 조정된 비 GAAP EPS에서 높은 한 자릿수에서 낮은 두 자릿수의 증가를 예상
3. 이자 비용을 연간 약 3,900만 달러 줄이는 새로운 자본 구조
4. 희귀 질환 부문이 ~2024년 프로 포르마 수익의 45%로 확장
5. 안과에서 Cortrophin Gel의 가속 성장 가능성
ANI는 정제된 Cortrophin® Gel과 제네릭을 포함한 독립 회사로서 2024년 재무 가이던스를 유지합니다.
ANI Pharmaceuticals (ANIP) a achevé l'acquisition d'Alimera Sciences, renforçant ainsi son segment des Maladies Rares. Cet accord ajoute environ 105 millions de dollars de revenus en 2024 sur une base pro forma et étend la portée d'ANI à 20 pays. Les points clés incluent:
1. Ajout de deux actifs commerciaux: ILUVIEN® et YUTIQ® avec un potentiel de croissance en ophtalmologie
2. Prévision d'une augmentation à un chiffre haut ou à un faible double chiffre de l'EPS ajusté non-GAAP en 2025
3. Nouvelle structure de capital réduisant les frais d'intérêt de environ 39 millions de dollars par an
4. Expansion du segment Maladies Rares à ~45% des revenus pro forma 2024
5. Potentiel de croissance accélérée de Cortrophin Gel en ophtalmologie
ANI maintient ses prévisions financières pour 2024 pour l'entreprise autonome basées sur le moment continu de Purified Cortrophin® Gel et des Génériques.
ANI Pharmaceuticals (ANIP) hat die Übernahme von Alimera Sciences abgeschlossen und somit sein Segment für seltene Krankheiten gestärkt. Die Vereinbarung fügt etwa 105 Millionen Dollar Umsatz im Jahr 2024 auf einer pro forma Basis hinzu und erweitert ANIs Präsenz auf 20 Länder. Die wichtigsten Punkte sind:
1. Hinzufügung zweier kommerzieller Vermögenswerte: ILUVIEN® und YUTIQ® mit Wachstumspotenzial in der Augenheilkunde
2. Erwartete hohe einstellige bis niedrige zweistellige Steigerung des bereinigten Non-GAAP EPS im Jahr 2025
3. Neue Kapitalstruktur, die die Zinsaufwendungen um etwa 39 Millionen Dollar jährlich senkt
4. Erweiterung des Segments für seltene Krankheiten auf ~45% der pro forma Einnahmen 2024
5. Potenzial für beschleunigtes Wachstum von Cortrophin Gel in der Augenheilkunde
ANI hält seine finanziellen Vorgaben für 2024 für das eigenständige Unternehmen basierend auf dem anhaltenden Schwung von Purified Cortrophin® Gel und Generika aufrecht.
- Acquisition adds approximately $105 million in 2024 revenue on a pro forma basis
- Expected high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS
- New capital structure reduces interest expense by approximately $39 million annually
- Expands Rare Disease segment to ~45% of pro forma 2024 revenues
- Adds two durable commercial assets (ILUVIEN® and YUTIQ®) with growth potential
- Expands global footprint to 20 countries in Europe and beyond
- Potential for accelerated growth of Cortrophin Gel in ophthalmology
- Record number of new patient starts for Cortrophin Gel in August
- Acquired $72.5 million of Alimera debt
- Issued $316.25 million in convertible senior notes due 2029
- Drew $325 million term loan to fund the acquisition
Insights
The acquisition of Alimera Sciences by ANI Pharmaceuticals marks a significant strategic move in the rare disease pharmaceutical sector. With an expected addition of
Financially, the deal looks promising with
This acquisition significantly bolsters ANI's position in ophthalmology, a key therapeutic area. The addition of ILUVIEN and YUTIQ, two durable assets with high barriers to genericization, complements ANI's existing Cortrophin Gel. The expanded reach to over 3,600 physicians and the
The momentum in Cortrophin Gel prescriptions, particularly in ophthalmology, is promising. However, the challenge lies in effectively leveraging this expanded portfolio to capture market share in a competitive landscape. The success of this strategy will depend on ANI's ability to execute its commercial plans and differentiate its products in the ophthalmology market.
This acquisition expands ANI's global footprint to 20 countries in Europe and beyond, marking a significant shift from a primarily U.S.-focused operation. This international expansion could provide new growth avenues but also brings challenges in navigating diverse regulatory environments and healthcare systems.
The transaction aligns with the broader trend of consolidation in the rare disease and specialty pharma sectors, as companies seek to build scale and diversify their portfolios. ANI's focus on rare diseases, now its largest growth driver, positions it well in a high-margin, high-growth segment of the pharmaceutical market. However, investors should watch for potential market reactions to the increased debt load and the execution risks associated with integrating a global operation.
- Strengthens Rare Disease segment as largest driver of future growth, adding approximately
$105 million in 2024 revenue on a pro forma basis - Adds two durable commercial assets ILUVIEN® and YUTIQ® with significant growth potential, expanding ANI’s foothold in strategic therapeutic area of ophthalmology
- Anticipated to drive high single-digit to low double-digit accretion in adjusted non-GAAP EPS in 2025 and to be substantially accretive thereafter
- New capital structure in place, reducing interest expense by approximately
$39 million on an annualized basis (1) - ANI maintains its 2024 financial guidance for the standalone Company based on continued momentum across Purified Cortrophin® Gel (Cortrophin Gel) and Generics
PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or “the Company”) (Nasdaq: ANIP) today announced the completion of its previously announced acquisition of Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”).
Nikhil Lalwani, President and CEO of ANI, stated, “Today marks a major milestone in our strategy to expand our Rare Disease business and deliver on our purpose of ‘Serving Patients, Improving Lives.’ Alimera is highly synergistic to our Rare Disease business, and we believe our proven commercial execution capabilities can further unlock the value of ILUVIEN and YUTIQ, two growing and durable assets, as well as accelerate the growth of Cortrophin Gel in ophthalmology. We continue to expect the transaction to create substantial shareholder value and generate high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS with substantially higher accretion thereafter.”
“With this acquisition, ANI now has three commercial rare disease assets, an expanded global footprint, and a robust Rare Disease team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology. I want to thank the employees of both companies and our advisors for their cooperation and diligence in closing this transformational transaction. We are thrilled to welcome Alimera to the ANI team,” concluded Lalwani.
Stephen Carey, Senior Vice President and Chief Financial Officer of ANI said, “ANI’s new capital structure provides us significant financial flexibility to support the integration of Alimera and continue investing in organic growth initiatives while also significantly reducing our interest expense and increasing cash flow.”
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(1) As compared to estimated interest expense that would have been incurred if the new principal amount of debt was subject to rates that would have applied under the previous debt capital structure
Transaction Rationale
- Solidifies Rare Disease segment as the largest driver of future growth: The combination with Alimera creates an attractive Rare Disease growth platform, adding approximately
$105 million in 2024 revenue on a pro forma basis and expanding the Rare Disease segment to approximately45% of pro forma 2024 revenues. The transaction also expands ANI’s footprint beyond the U.S. to 20 countries in Europe and beyond. - Adds two durable commercial products with significant growth potential that leverage the Company’s existing Rare Disease infrastructure: ILUVIEN and YUTIQ are durable assets with high barriers to genericization which the Company believes have a clear role for patients in need of alternative therapeutic options. ANI sees the potential to unlock significant additional growth for both ILUVIEN and YUTIQ through commercial synergies and execution.
- Expands foothold in ophthalmology and expected to accelerate growth of Cortrophin Gel in this key therapeutic area: During the first quarter of 2024, ANI launched a targeted ophthalmology-focused sales force for Cortrophin Gel. The team has continued to gain momentum in ophthalmology, driving significant growth in the number of new patient starts in the second quarter and third quarter to date. Importantly, the addition of Alimera expands the reach of the ophthalmology sales team to over 3,600 physicians. The Company estimates that there is over
50% overlap between high potential prescribers of Cortrophin Gel, ILUVIEN and YUTIQ. - Offers potential for substantial shareholder value creation: ANI continues to expect high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS with substantial accretion thereafter. The transaction is anticipated to deliver an additional
$35 -$38 million in 2025 adjusted non-GAAP EBITDA inclusive of approximately$10 million in identified cost synergies with additional EBITDA contribution expected from accelerated growth of Cortrophin Gel within ophthalmology.
Business Updates
- Cortrophin Gel: ANI continues to see momentum across all targeted specialties and prescription growth across both existing and new prescribers. In August, the Cortrophin Gel franchise experienced a record number of new patients starts and the Company believes there is significant room for future growth as the number of patients on ACTH therapy remains significantly lower it was than a few years ago.
- Generics: Strong R&D capabilities enabled ANI to launch four products in the third quarter to date, bringing the number of products launched year-to-date to fourteen. In addition, the Company’s operational excellence leveraging its U.S. based manufacturing footprint and a robust FDA compliance track record continues to enable ANI to deliver high-single-digit to low double-digit growth in Generics.
- Alimera Integration: ANI has made substantial progress on integration planning and expects the combined ophthalmology commercial team to begin generating synergies across Cortrophin Gel, ILUVIEN and YUTIQ in the near-term. The Company will leverage its manufacturing, quality, and regulatory expertise to further strengthen supply-security for ILUVIEN and YUTIQ.
- Guidance: ANI is maintaining its 2024 guidance for the standalone Company based on continued momentum across Cortrophin Gel and Generics and plans to provide 2024 guidance for the combined Company by no later than the Company’s third quarter earnings call.
Terms of the Transaction
- Under the terms of the merger agreement, ANI acquired all of the outstanding shares of Alimera for
$5.50 per share. The Company also repaid$72.5 million of Alimera debt. Alimera investors received one non-tradable contingent value right (CVR) representing the right to receive up to$0.50 per share upon the achievement of certain net revenue targets in 2026 and 2027.
New Capital Structure
- ANI recently completed an offering of
$316.25 million aggregate principal amount of2.25% convertible senior notes due September 1, 2029. The Company utilized a majority of the net proceeds as well as cash from its balance sheet to repay in full its existing senior secured term loan facility ($292.5 million that carried an interest rate of SOFR+6.0% ). The initial conversion price of the convertible notes is$74.11 per share. Concurrent with the convertible offering, the Company used$40.6 million of the net proceeds to enter into capped call transactions. The cap price of the capped call transactions is initially$114.02 per share, which represents a premium of100% over the last reported sale price of the Company’s common stock on August 7, 2024. The capped call transactions are expected generally to reduce the potential dilution to ANI’s common stock upon any conversion of the notes up to the cap price of$114.02 . - To fund the acquisition of Alimera, ANI entered into a new senior secured credit agreement consisting of a
$325 million delayed draw term loan facility and$75 million revolving credit facility (initial interest rate SOFR+2.75% ). On September 16, 2024 the Company drew the full$325 million term loan; the$75 million revolving credit facility remains un-drawn. - The Company expects these capital structure changes to reduce interest expense by approximately
$39 million on an annualized basis as compared to estimated interest expense that would have been incurred if the new principal amount of debt was subject to rates that would have applied under the previous debt capital structure.
Advisors
Guggenheim Securities, LLC acted as lead financial advisor to ANI and Raymond James & Associates, Inc. also acted as financial advisor. Hughes Hubbard & Reed LLP acted as legal advisor to ANI. Centerview Partners LLC acted as lead financial advisor to Alimera, and Perella Weinberg Partners also acted as a financial advisor to Alimera. DLA Piper acted as legal advisor to Alimera.
About ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. ANI is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint.
Forward-Looking Statements
This press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s expectations or beliefs concerning future events, including statements regarding the benefits of the acquisition of Alimera Sciences. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “continue,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,” “would” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the ability to implement business plans, forecasts, and other expectations in connection with the acquisition and integration of Alimera Sciences, and identify and realize additional opportunities and, in particular, the possibility that the Company is unable to achieve anticipated synergies, (ii) costs and regulatory requirements relating to contract manufacturing arrangements, (iii) costs or delays associated with manufacturing (including the sources and any changes in sources thereof) of the Company’s products, (iv) delays or failures in retaining and obtaining continuing and future product approvals from the FDA, and other regulatory issues relating to the Company's business and products, (v) market trends for the Company’s products, including but not limited to, ILUVIEN, YUTIQ and Cortrophin Gel, and the ability to achieve anticipated sales for such products, (vi) risks that the acquisition of Alimera may disrupt current plans and operations of the Company and potential difficulties of the Company in retaining employees of Alimera and/or maintaining business relationships of Alimera, (vii) the impact of any litigation to which the Company is, or may become, a party, including in connection with the acquisition and integration thereof, (viii) volatility in the Company’s stock price, including as a result of the acquisition, (ix) changes in competitive and regulated industries in which the Company operates, variations in operating performance across competitors, changes in laws and regulations affecting the Company’s business, and changes in the Company’s capital structure as a result of the acquisition, (x) regulatory and other approvals relating to product development and manufacturing, (xi) the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries and/or the Company and its products, (xii) costs incurred in connection with the acquisition of Alimera and the possibility that the Company is unable to realize anticipated benefits of the acquisition or to realize estimated pro forma results and underlying assumptions, (xiii) delays in production, increased costs and potential loss of revenues if there is a change in manufacturers or manufacturing processes due to the limited number of suppliers for the Company’s raw materials, active pharmaceutical ingredients, excipients and other materials, (xiv) the Company’s reliance on single source third-party contract manufacturing supply for certain of its key products, including ILUVIEN, YUTIQ and Cortrophin Gel, (xv) changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration, and other regulatory agencies, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions, (xvi) the impact of legislative or regulatory reform on the pricing for the Company’s products, (xvii) the Company’ ability to maintain the services of its key executives and other personnel, and (xviii) general business and economic conditions, such as inflationary pressures, geopolitical conditions including, but not limited to, the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies.
This press release refers to financial measures that are not in accordance with U.S. generally accepted accounting principles (“GAAP”). Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. A reconciliation of the forward-looking non-GAAP measures presented in this communication is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on future financial performance. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this communication.
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
FAQ
How much additional revenue is ANI Pharmaceuticals (ANIP) expecting from the Alimera acquisition in 2024?
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