
INTRODUCTION
Unless the context otherwise indicates, as used in this "Management's Discussion and Analysis of Financial Condition and Results of Operations," the terms "we," "us," "our," "Bausch + Lomb ," the "Company," and similar terms refer toBausch + Lomb Corporation and its subsidiaries. This "Management's Discussion and Analysis of Financial Condition and Results of Operations" has been updated throughNovember 2, 2022 and should be read in conjunction with the unaudited interim Condensed Consolidated Financial Statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q for the quarterly period endedSeptember 30, 2022 (this "Form 10-Q"). The matters discussed in "Management's Discussion and Analysis of Financial Condition and Results of Operations" contain certain forward-looking statements within the meaning of Section 27A of The Securities Act of 1933, as amended (the "Act"), and Section 21E of The Securities Exchange Act of 1934, as amended, and that may be forward-looking information within the meaning defined under applicable Canadian securities laws (collectively, "Forward-Looking Statements"). See "Forward-Looking Statements" at the end of this discussion. Our accompanying unaudited interim Condensed Consolidated Financial Statements as ofSeptember 30, 2022 and for the three and nine months endedSeptember 30, 2022 and 2021 have been prepared in accordance with accounting principles generally accepted inthe United States of America ("U.S. GAAP") and the rules and regulations of theUnited States Securities and Exchange Commission (the "SEC") for interim financial statements, and should be read in conjunction with our Combined Financial Statements for the year endedDecember 31, 2021 , which are included inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating toBausch + Lomb's Registration Statement on Form S-1 andBausch + Lomb's supplemented PREP prospectus filed with the Canadian Securities Administrators (the "CSA") onMay 5, 2022 . In our opinion, the unaudited interim Condensed Consolidated Financial Statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for a fair statement of the financial condition, results of operations and cash flows for the periods indicated.Additional Company information is available on SEDAR at www.sedar.com and on theSEC website at www.sec.gov. All currency amounts are expressed inU.S. dollars, unless otherwise noted.
OVERVIEW
Bausch + Lomb is a subsidiary of Bausch Health Companies Inc. ("BHC"), with BHC currently holding, directly or indirectly, approximately 88.7% of the common shares ofBausch + Lomb .Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. We develop, manufacture and market a range of products, primarily in the areas of eye health, which are marketed directly or indirectly in approximately 100 countries. As a fully integrated eye health business,Bausch + Lomb has an established line of contact lenses, intraocular lenses and other medical devices, surgical systems and devices, vitamin and mineral supplements, lens care products, prescription eye-medications and other consumer products that positions us to compete in all areas of the eye health market. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,800 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. Reportable Segments Our portfolio of products falls into three operating and reportable segments: (i) Vision Care (formerlyVision Care/Consumer Health ), (ii)Ophthalmic Pharmaceuticals and (iii) Surgical. We have found and continue to believe there is significant opportunity in these businesses and we believe our existing portfolio, commercial footprint and pipeline of product development projects position us to successfully compete in these markets and provide us with the greatest opportunity to build value for our shareholders. The following is a brief description of the Company's segments: The Vision Care segment-includes both our contact lens and consumer eye care businesses, and includes leading products such as our Biotrue® ONEday daily disposables and our Biotrue® multi-purpose solution. Our contact lens portfolio spans the spectrum of wearing modalities, including daily disposable and frequently replaced contact lenses, and contact lenses that are indicated for therapeutic use and that can also provide optical correction during healing, if required. In particular, our Vision Care contact lens portfolio includes our Bausch + Lomb INFUSE® (silicone 31 --------------------------------------------------------------------------------
hydrogel (“SiHy”) daily disposable contact lenses, Biotrue® ONEday daily
disposables, PureVision® SiHy contact lenses, SofLens® daily disposables and
Bausch + Lomb ULTRA® contact lenses.
Our consumer eye care business consists of contact lens care products, over-the-counter ("OTC") eye drops that address various conditions, including eye allergies, conjunctivitis, dry eye, and redness relief, and eye vitamins and mineral supplements. Our Eye Vitamin Products include our PreserVision® AREDS 2 formula, which contains the exact levels of six key nutrients recommended by theNational Eye Institute to help reduce the risk of progression in patients with moderate to advanced age-related macular degeneration ("AMD"), and supplements, that support general eye health. Within our consumer eye care business, our lens care product portfolio includes Biotrue® and Renu® multipurpose solutions and Boston® cleaning and conditioning solutions, our eye drops include LUMIFY®, Soothe®, Artelac®, Alaway® and Mioclear™ and our Eye Vitamins include PreserVision® and Ocuvite®. For the year endedDecember 31, 2021 , our Vision Care segment had seven product franchises that generated over$100 million in annual revenues, as follows: PreserVision®/Ocuvite®, Biotrue®, SofLens®, Renu®, Bausch + Lomb ULTRA®, Artelac® and LUMIFY®.The Ophthalmic Pharmaceuticals segment-consists of a broad line of proprietary and generic pharmaceutical products for post-operative treatments and treatments for a number of eye conditions, such as glaucoma, eye inflammation, ocular hypertension, dry eyes and retinal diseases. Key proprietary ophthalmic pharmaceutical brands are VYZULTA®, Lotemax®, Prolensa® and Minims®. The Surgical Segment-consists of medical device equipment, consumables and technologies for the treatment of corneal, cataracts, and vitreous and retinal eye conditions, which includes intraocular lenses ("IOLs") and delivery systems, phacoemulsification equipment and other surgical instruments and devices necessary for cataract surgery. Key surgical brands include Akreos®, AMVISC®, Crystalens® IOLs, enVista® IOLs, Millennium®, Stellaris Elite® vision enhancement system, Storz® ophthalmic instruments, VICTUS® femtosecond laser, Teneo™, Eyefill® and Zyoptix®.
Initial Public Offering and Separation of the Bausch + Lomb Eye Health Business
OnAugust 6, 2020 , our parent company, BHC, announced its plan to separate our eye health business into an independent publicly traded entity, separate from the remainder of BHC (the "Separation"). InJanuary 2022 , BHC completed the internal organizational design and structure of our new eye health entity. The next step in the Separation was an initial public offering of the common shares ofBausch + Lomb . The registration statement related to the initial public offering ofBausch + Lomb (the "B+L IPO") was declared effective onMay 5, 2022 , and our common stock began trading on theNew York Stock Exchange and theToronto Stock Exchange , in each case under the ticker symbol "BLCO", onMay 6, 2022 . Prior to the completion of the B+L IPO, we were an indirect wholly-owned subsidiary of BHC. OnMay 10, 2022 , a wholly-owned subsidiary of BHC (the "Selling Shareholder") sold 35,000,000 common shares ofBausch + Lomb , at an offering price of$18.00 per share (less the applicable underwriting discount), pursuant to theBausch + Lomb prospectus. In addition, the Selling Shareholder granted the underwriters an option for a period of 30 days from the date of the B+L IPO to purchase up to an additional 5,250,000 common shares to cover over-allotments at the IPO offering price less underwriting commissions. OnMay 31, 2022 , the underwriters of the B+L IPO partially exercised the over-allotment option granted to them by the Selling Shareholder, and, onJune 1, 2022 , the Selling Shareholder sold an additional 4,550,357 common shares ofBausch + Lomb , at an offering price of$18.00 per share (less the applicable underwriting discount). The Selling Shareholder received all net proceeds from the B+L IPO. The remainder of the over-allotment option granted to the underwriters expired. Upon the closing of the B+L IPO (after giving effect to the partial exercise of the over-allotment option), BHC directly or indirectly holds 310,449,643Bausch + Lomb common shares, which represents approximately 88.7% of our common shares. The completion of the separation ofBausch + Lomb is subject to the expiry of customary lockups related to the B+L IPO (which have now expired) and, the achievement of targeted debt leverage ratios, subject to market conditions and the receipt of applicable shareholder and other necessary approvals and the various risk factors relating to the separation approvals set forth inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating to our Registration Statement on Form S-1 and inBausch + Lomb's supplemented PREP prospectus as filed with the CSA onMay 5, 2022 , under the section entitled "Risk Factors". We understand that BHC continues to believe that completing the B+L Separation makes strategic sense and that BHC continues to evaluate all factors and considerations related to completing the Separation, including the effect of the Norwich Legal Decision (as defined below) .
See Note 2, “SIGNIFICANT ACCOUNTING POLICIES” to our unaudited interim Condensed
Consolidated Financial Statements for additional information.
32 -------------------------------------------------------------------------------- We believe the Separation presentsBausch + Lomb with a unique opportunity, and will provide us operating flexibility and put us in a strong position to unlock additional value in our eye health business as a separate and dissimilar business from the remainder of BHC's product portfolios and businesses. As a separate entity,Bausch + Lomb's management believes that it is positioned to focus on its core businesses to drive additional growth, more effectively allocate capital and better manage our capital needs. Further, the Separation will allow us and the market to compare the operating results of our eye health business with other "pure play" eye health companies. Although management believes these transactions will unlock value for our shareholders, there can be no assurance that the Separation will be consummated, or, even if consummated, that the Separation will be successful in doing so. See "Risk Factors - Risks Relating to the Separation" included inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating toBausch + Lomb's Registration Statement on Form S-1 and inBausch + Lomb's supplemented PREP prospectus as filed with the CSA onMay 5, 2022 . Positioning for Growth Product Development
We continuously search for new product opportunities through internal
development and strategic licensing agreements, that, if successful, will allow
us to leverage our commercial footprint and supplement our existing product
portfolio and address specific unmet needs in the market.
We are focused on bringing innovative products to market to serve doctors, patients, and consumers in the pursuit of helping people see better to live better all over the world. We consistently look for key trends in the eye health market to meet changing doctor, patient, and consumer needs and identify areas for investment to expand our market share and maintain our leading positions across business segments. Our leadership team actively manages our pipeline in order to identify what we believe are innovative and realizable projects that meet the unmet needs of consumers, patients and eye health professionals and are expected to provide incremental and sustainable revenues and growth into the future. We believe that our current pipeline is strong enough to meet these objectives and provide future sources of revenues, in our core businesses, sufficient enough to sustain our growth and corporate health as other products in our established portfolio face generic competition and lose momentum. We believe our unparalleled eye health knowledge and insights allow us to capitalize on market trends by differentiating our approach to product development, with a pipeline focused on prioritizing customer needs and actively seeking external innovation to design, develop and advance creative, ethical eye health products across our portfolio, to address unmet and evolving needs of eye care professionals, patients and consumers. Our team of approximately 850 dedicated Research and Development ("R&D") employees is focused on advancing our pipeline and identifying new product opportunities and we believe we have a significant innovation opportunity today. We plan to develop and commercialize our global pipeline of over 60 projects, many of which are global projects being developed in and for multiple countries. These global and individual projects are in various stages of pre-clinical and clinical development, including new contact lenses and prescription medications for myopia, next-generation cataract equipment, premium IOLs, investigational treatments for dry eye, novel formulation for eye vitamins, preservative free formulation of eye drops and, next-generation cataract equipment, among others, that are designed to grow our portfolio and accelerate future growth. Our internal R&D organization focuses on the development of products through clinical trials. As ofSeptember 30, 2022 , we have over 60 projects in our global pipeline which are being developed in and for multiple countries. Certain core internal R&D projects that have received a significant portion of our R&D investment in current and prior periods are listed below.
Vision Care Pipeline
We believe that vision care is a very innovation-sensitive market. As a result, we believe our vision care business will achieve growth through our focus on new materials and products. We have leveraged our expertise in eye health to build a vision care pipeline based on innovative next generation materials and products, and we intend to continue developing our pipeline through a combination of internal and external business development initiatives. Our range of vision care pipeline products are as follows:
Contact Lens Pipeline
We are developing new materials and expect to continue to introduce innovative products, like our Bausch + Lomb INFUSE® contact lens, which is a silicone hydrogel daily disposable contact lens designed with a next generation material infused with ProBalance Technology™ to help maintain ocular surface homeostasis and help reduce symptoms of contact lens dryness. Silicone hydrogel materials provide increased oxygen transmission for eye health, improved safety and 33 -------------------------------------------------------------------------------- increased comfort for end users. This combination should continue to benefit our other SiHy brands: Bausch + Lomb ULTRA®, AQUALOX™ and PureVision®. Our contact lens pipeline includes: •SiHy Daily - A silicone hydrogel daily disposable contact lens designed to provide clear vision throughout the day. InSeptember 2018 , we launchedSiHy Daily inJapan under the branded name AQUALOX™ ONE DAY. InAugust 2020 , we launchedSiHy Daily in theU.S. under the branded name Bausch + Lomb INFUSE® SiHy Daily Disposable contact lens. In the fourth quarter of 2020,SiHy Daily was launched inAustralia ,Hong Kong andCanada under the branded name Bausch + Lomb Ultra® ONE DAY.SiHy Daily has also received regulatory approval inChina ,New Zealand ,Japan ,South Korea ,Europe ,Singapore andMalaysia , where it will be branded as Bausch + Lomb Ultra® ONE DAY, and, in the second quarter of 2021, we launchedSiHy Daily inSouth Korea andSingapore as Bausch + Lomb Ultra® ONE DAY. •InOctober 2020 , we announced that we had entered into an exclusive global licensing agreement withBrien Holden Vision Institute ("BHVI" and the license, the "BHVI License") for a myopia control contact lens design developed by BHVI. We plan to pair BHVI's novel contact lens design with our leading contact lens technologies to develop potential contact lens treatments designed to slow the progression of myopia in children. A global clinical trial is expected to begin in 2023.
•We are developing a custom-finished orthokeratology lens with a proprietary
software based fitting system for the treatment of myopia, especially in
children, which we expect to launch in 2023, subject to FDA approval.
•We are developing certain cosmetic contact lenses with improved color
technology, which has been recently approved in
certain other Asian markets in 2023 and 2024.
•InJune 2022 , we launched Revive™ custom soft contact lenses inthe United States . Revive™ is a new family of customizable soft contact lenses, which are available in spherical, toric, multifocal and multifocal toric options and are designed to meet the vision needs of more patients, including those with high or unique prescriptions. Consumer Eye Care Pipeline We have built and strengthened our consumer eye care product pipeline through internal development initiatives and external business development opportunities and intend to continue developing our pipeline through a combination of internal and external business development initiatives. Our consumer eye care product pipeline includes: •LUMIFY® (brimonidine tartrate ophthalmic solution, 0.025%) - An OTC eye drop developed as an ocular redness reliever. We launched this product in theU.S. inMay 2018 and inCanada inJune 2022 . Currently, we have several new line formulations under development. The first Phase 3 study in support of these line extensions has initiated. Additional studies have commenced duringOctober 2022 . •Renu® Advanced Multi-Purpose Solution ("MPS") - Contains a triple disinfectant system that kills 99.9% of germs tested, and has a dual surfactant system that provides up to 20 hours of moisture. Renu® Advanced MPS is FDA cleared with indications for use to condition, clean, remove protein, disinfect, rinse and store soft contact lenses including those composed of silicone hydrogels. Prior to 2022, Renu® Advanced MPS was launched inIndia ,Mexico ,Korea ,Turkey andGreece and gained regulatory approvals inIndonesia ,Malaysia ,Singapore , theEuropean Union ,Belarus andChina . In 2022, Renu® Advanced MPS was launched inTaiwan ,Czech Republic ,Israel ,Poland ,Slovakia ,China ,Argentina , Columbia,Ecuador andPeru . We anticipate launches inSlovenia , other parts ofEurope and the Nordic regions. •Biotrue® Hydration Plus Multi-Purpose Solution - A next generation Biotrue® MPS that contains 25% more Hyaluronan (HA), triple disinfectant system that kills 99.9% of germs tested, dual surfactant system that provides lens conditioning/cleaning and erythritol providing antioxidant properties. This formulation provides up to 20 hours of hydration. Biotrue® Hydration Plus MPS isU.S. FDA andHealth Canada cleared with indications for use to condition, clean, remove protein, disinfect, rinse and store soft contact lenses including those composed of silicone hydrogels. Biotrue® Hydration Plus MPS was launched in theU.S. andCanada in 2022 and has gained regulatory approval fromChina's National Medical Products Administration ("NMPA"). We anticipate launching inChina in the second half of 2023. •Preservative Free Biotrue® Hydration Boost lubricant eye drops was launched in theU.S. duringJune 2021 . This formulation is enhanced with Hyaluronan (HA), electrolytes, an anti-oxidant and marketed in a preservative free multi-dose container. Additional line extensions are currently under development. 34 --------------------------------------------------------------------------------
Ophthalmic Pharmaceutical Pipeline
We intend to strengthen our innovative pharmaceuticals pipeline through internal development and external business development opportunities with a focus on life cycle management, generics and biosimilars, dry eye and "back of the eye" diseases. Our range of ophthalmic pharmaceutical pipeline products include: •InOctober 2019 , we acquired an exclusive license from Clearside Biomedical, Inc. ("Clearside" and the license, the "Clearside License") for the commercialization and development of XIPERE® (triamcinolone acetonide suprachoroidal injectable suspension) in theU.S. andCanada . XIPERE® is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside's proprietary SCS Microinjector®. InOctober 2021 , the FDA approved XIPERE® for suprachoroidal use for the treatment of macular edema associated with uveitis. We launched XIPERE® in the first quarter of 2022, and believe that it is the first and only therapy currently available in theU.S. for suprachoroidal use for the treatment of macular edema associated with uveitis. •InDecember 2019 , we announced that we had acquired an exclusive license fromNovaliq GmbH (the "Novaliq License") for the commercialization and development in theU.S. andCanada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug that if approved by the FDA will have a novel mechanism of action to treat dry eye disease ("DED") associated with Meibomian Gland Dysfunction ("MGD"). InApril 2021 , we announced statistically significant topline data from the first of two Phase 3 studies, and, inSeptember 2021 , we announced statistically significant topline data from the second Phase 3 study. The New Drug Application was filed with the FDA inJune 2022 (and accepted by the FDA inSeptember 2022 with a Prescription Drug User Fee Act (PDUFA) date ofJune 28, 2023 ), and, if approved, we anticipate launching in theU.S. in the second half of 2023. If approved by the FDA, we believe the addition of this investigational treatment for DED with MGD will help build upon our strong portfolio of integrated eye health products. We expect to make our Canadian filing in the first half of 2023. •Under the terms of anOctober 2020 agreement with Eyenovia, Inc., we have acquired an exclusive license (the "Eyenovia License") in theU.S. andCanada for the development and commercialization of an investigational microdose formulation of atropine ophthalmic solution; a potentially first-in-class investigational treatment of the reduction of pediatric myopia progression. Microdose administration is designed to result in low systemic and ocular drug exposure. We expect to complete enrollment for a Phase 3 study during 2023. If approved by the FDA, we believe this investigational product could potentially change the treatment paradigm for the reduction of myopia progression in children. •InMay 2020 , we entered into an exclusive license agreement (the "STADA-Xbrane License") with STADA Arzneimittel AG and its development partner, Xbrane Biopharma AB ("Xbrane"), to commercialize in theU.S. andCanada a biosimilar candidate to Lucentis® (ranibizumab), a VEGF inhibitor used in the treatment of serious eye diseases, such as wet AMD. We expect, subject to FDA alignment, that Xbrane will resubmit the abbreviated Biologics License Application ("aBLA") for the product by the end of 2022 and we anticipate launching the product in theU.S. in late 2023 or early 2024 (depending on the exact timing of such resubmission).
Surgical Pipeline
We have built and strengthened our ophthalmic surgical pipeline through internal and external development and licensing initiatives and intend to continue developing our pipeline through a combination of internal and external business development initiatives. Our range of surgical pipeline products are developed with the goal to reinforce our position in existing segments, as well as entering new segments in order to broaden the offering. Our surgical pipeline includes: •In the first quarter of 2021, we launched LuxSmartTM IOLs with extended depth of focus ("EDOF") design. We started first implantation inDecember 2020 , and we expanded prelaunch activities in theU.K. ,France ,Germany ,Sweden ,Italy ,Spain ,Poland ,Hong Kong and theCzech Republic in the first quarter of 2021. During the remainder of 2021, we expanded the launch of LuxSmartTM IOLs to other European countries, includingBelgium ,Netherlands ,Norway ,Portugal ,Switzerland ,Greece ,Bulgaria ,Hungary ,Romania andSerbia . We expect to expand the launch of LuxSmartTM IOLs in select other markets in 2023. •We are expanding our portfolio of premium IOLs built on the enVista® platform with Monofocal Plus, EDOF and Trifocal optical designs for presbyopia correction. We expect that they will be commercialized together with a new preloaded inserter with two options: non-Toric, as well as Toric for astigmatism patients. We anticipate launching Monofocal Plus, Trifocal and EDOF optical designs for presbyopia in theU.S. in 2023, 2024 and 2025/2026, respectively. 35 -------------------------------------------------------------------------------- •We are developing a new generation Phaco and Vitroretinal combined surgical system that we expect will be a future innovation that builds on the existing Stellaris Elite® vision enhancement system by introducing a new fluidics system, enhancing interconnectivity and networking, expanding surgical parameters and offering a wide range of new peripherals to enhance the surgeons' control throughout the surgical procedures. •We are developing two new femto lasers with advanced technology that we expect to launch in 2024. These products are designed for the cataract and refractive surgery markets. •We are developing new innovative, personalized corneal treatments for our Teneo™ Excimer laser, which we expect to launch in theU.S. in 2023, subject to FDA approval. •New Ophthalmic Viscosurgical Device ("OVD") product - A formulation to protect corneal endothelium during phacoemulsification process during a cataract surgery and to help chamber maintenance and lubrication during IOL delivery. A clinical study report was completed for the cohesive OVD product (StableVisc™) during the second quarter of 2022. FDA approval is expected in the fourth quarter of 2022 and launch is expected in the first quarter of 2023. In addition, inMarch 2021 , we received Premarket Approval from the FDA for Clearvisc® dispersive OVD, which we launched in theU.S. inJune 2021 .
Strategic Licensing Agreements
To supplement our internal R&D initiatives and to build-out and refresh our product portfolio, we also search for opportunities to augment our pipeline through arrangements that allow us to gain access to unique products and investigational treatments, by strategically aligning ourselves with other innovative product solutions. Our strategic licensing agreements include the BVHI License outlined in the discussion of our Vision Care pipeline above and the Clearside License, Novaliq License, Eyenovia License and STADA-Xbrane License each outlined in the discussion of our Ophthalmic Pharmaceutical product pipeline above. In addition, duringJuly 2022 , we entered into an exclusive European distribution agreement withSanoculis Ltd. ("Sanoculis") for Sanoculis' Minimally Invasive Micro Sclerostomy ("MIMS®"). MIMS® is an innovative minimally invasive surgical procedure for the treatment of glaucoma. We also made an equity investment in Sanoculis as part of a Series C round of funding and have an option to acquire all of the assets of Sanoculis. We believe this distribution agreement, as well as the equity stake and option, will help build upon our strong portfolio of integrated eye health products. In the normal course of business, we will enter into select licensing and collaborative agreements for the commercialization and/or development of unique products. These products are sometimes investigational treatments in early stage development that target unique conditions. The ultimate outcome, including whether the product will be: (i) fully developed, (ii) approved by the FDA or other regulators, (iii) covered by third-party payors or (iv) profitable for distribution, is highly uncertain. Under certain agreements, the Company may be required to make payments contingent upon the achievement of specific developmental, regulatory, or commercial milestones.
We are and we will continue to consider further strategic licensing
opportunities to address the unmet needs of the consumer, patient and eye health
professional, some of which could be material in size.
Strategic Acquisitions
We selectively consider any acquisition that we believe aligns well with our
current organization and strategic plan. We seek to enter into only those
acquisitions that provide us with significant synergies with our existing
business, thereby minimizing risks to our core businesses and providing
long-term growth opportunities.
We are considering further acquisition opportunities within our core therapeutic
areas, some of which could be material in size.
Sales Force Expansion
We have an established sales network that uniquely positions us to meet customers' demands across the geographies we serve, building deeply loyal and enduring relationships. Through our teams, we are engaged with various physician and patient associations across the world. These professional relationships are the foundation of our proven track record of converting innovation into trusted products with high sales and provide us additional patient insights and consumer feedback that virtuously informs the innovation effort. We look for opportunities to strategically expand our sales force in specific geographies as needed and in support of new product launches, most recently in support of our launches of our Bausch + Lomb INFUSE®, Biotrue® ONEday and Bausch + Lomb ULTRA® contact lenses in order to drive growth and maximize the return on our product portfolio. 36
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e-Commerce
We see an opportunity in e-Commerce for growth, which now represents more than 10% of our Vision Care revenues. We believe that the trend of using e-Commerce platforms to shop for our products will continue to affect our business due to the convenience of online ordering and subscription delivery. We believe that our products are well suited to sales through e-Commerce channels as they are shelf stable, inexpensive to ship as our products are light in weight, and easy to transport. Additionally, the recurring purchase cycles for many of our products will position them to capitalize on continued growth of subscription services. We continue to look for additional opportunities to invest in these platforms to meet consumer demand and drive growth.
Investment in Our Manufacturing Facilities
In support of our core businesses, we have made and continue to make strategic investments in our infrastructure, the most significant of which are at ourWaterford facility inIreland , our Rochester facility inNew York and ourLynchburg facility inVirginia . We note that continued investment in our infrastructure remained an area of our focus and transformation. We have identified and continue to identify opportunities to increase our capacity to manufacture our products to meet forecasted global demand, particularly in our Vision Care product lines. Our projects have included emphasis on developing new technologies to assist in the manufacture, inspection, and packaging of contact lenses to drive efficiencies in our manufacturing processes.
Additionally, we have increased and continue to increase our investments to
enhance our supply chain and distribution capabilities in both the
international locations. These recent investments in our supply chain included
adding additional distribution capabilities for medical devices, primarily
contact lens products.
From a manufacturing and distribution expansion perspective, we have made approximately$785 million in capital expenditures/commitments over the past 5 years to increase capacity and meet increased demand for our products. We believe the continued investments in our infrastructure, most specifically theWaterford , Rochester andLynchburg facilities, further demonstrates the growth potential we see in our products.
Our Competitive Environment
We operate in a marketplace with many competitors and face competition from competitors' products and new products entering the market. We also face the threat of competition from new entrants to our markets as well as from existing competitors, including those overseas who may have lower production costs. In order to protect and grow our market share we: (i) actively manage our pricing, (ii) refresh our product portfolio with innovative new products and (iii) manage our product portfolio to address generic competition.
Business Trends
In addition to the actions previously outlined, the events described below have
affected and may affect our business trends. The matters discussed in this
section contain Forward-Looking Statements. Please see “Forward-Looking
Statements” for additional information.
Russia-Ukraine War
InFebruary 2022 ,Russia invadedUkraine . As military activity and sanctions againstRussia ,Belarus and specific areas ofUkraine have continued, the war has increasingly affected economic and global financial markets and exacerbated ongoing economic challenges, including issues such as rising inflation and global supply-chain disruption. Our revenues attributable toRussia for the nine months endedSeptember 30, 2022 and 2021 were$90 million and$75 million , respectively. Our revenues attributable toUkraine for the nine months endedSeptember 30, 2022 and 2021 were$5 million and$7 million , respectively. Our revenues attributable toBelarus for the nine months endedSeptember 30, 2022 and 2021 were$6 million and$5 million , respectively. As the geopolitical situation inEastern Europe continues to intensify, political events and sanctions are continually changing, and we continue to assess the impact of theRussia -Ukraine war will have on our businesses. These impacts may include but are not limited to: (i) interruptions or stoppage of production, (ii) damage or loss of inventories, (iii) supply-chain and product distribution disruptions inEastern Europe , (iv) volatility in commodity prices and currencies, (v) disruption in banking systems and capital markets, (vi) reductions in sales and earnings of business in affected areas, (vii) increased costs and (viii) cyberattacks. To date, these challenges have not yet had a material impact on our operations; however, the ongoing conflict in this region and the sanctions and other actions by the global community in response has hindered (and we anticipate will continue to hinder) our ability to conduct business with customers and vendors in this region. For example, we expect to experience further disruption and delays in the supply of our products to our customers inRussia ,Belarus andUkraine . We may also experience further decreased demand for our products in these countries as a result of the conflict and invasion. In addition, 37 -------------------------------------------------------------------------------- we may experience difficulties in collecting receivables from such customers. If we continue to be hampered in our ability to conduct business with new or existing customers and vendors in this region, our business, and operations, including our revenues, profitability and cash flows, could be adversely impacted. Furthermore, if the sanctions and other retaliatory measures imposed by the global community change, we may be required to cease or suspend our operations in the region or, should the conflict worsen, we may voluntarily elect to do so. We cannot provide assurance that current sanctions or potential future changes in these sanctions or other measures will not have a material impact on our operations inRussia ,Belarus andUkraine . The disruption to or suspension of our business and operations inRussia ,Belarus andUkraine may have a material adverse impact on our business, financial condition, cash flows and results of operations. We will continue to monitor the impacts of theRussia -Ukraine war on macroeconomic conditions and continually assess the effect these matters may have on our businesses. For a further discussion of these and other risks relating to our international business, see "Risk Factors-Risks Relating to the International Scope of our Business" included inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating toBausch + Lomb's Registration Statement on Form S-1 and inBausch + Lomb's supplemented PREP prospectus as filed with the CSA onMay 5, 2022 .
Impacts of COVID-19 Pandemic
The unprecedented nature of the COVID-19 pandemic has, and continues to, adversely impact the global economy. The COVID-19 pandemic and the reactions of governments, private sector participants and the public in an effort to contain the spread of the COVID-19 virus and/or address its impacts have had significant direct and indirect effects on businesses and commerce. This includes, but is not limited to, disruption to supply chains, employee base and transactional activity, facilities closures and production suspensions. Our revenues were most negatively impacted during our second quarter of 2020 by certain social restrictions and other precautionary measures taken in response to the COVID-19 pandemic. However, as governments began lifting social restrictions, allowing offices of certain health care providers to reopen and certain surgeries and elective medical procedures to proceed, the negative trend in the revenues of certain businesses began to level off and stabilize prior to our third quarter of 2020. After the launch of effective vaccines inDecember 2020 , infection rates began to decline, signaling the beginning of a recovery from the COVID-19 pandemic. Our revenues gradually returned to pre-pandemic levels for many of our businesses and geographies throughout 2021. However, in some regions, includingChina (as further described below), we continued to experience negative impacts of the COVID-19 pandemic on our business in those regions. The rates of recovery for each business will vary by geography and will be dependent upon, among other things, the availability and effectiveness of vaccines for the COVID-19 virus and variant and subvariant strains thereof, government responses, rates of economic recovery, precautionary measures taken by patients and customers, the rate at which remaining social restrictions are lifted and, once lifted, the presumption that social restrictions will not be materially reenacted in the event of a resurgence of the virus or variant and subvariant strains thereof and other actions taken in response to the COVID-19 pandemic. The outbreak of the omicron variant inChina in 2022 has resulted in government enforced lockdowns and other social restrictions, which impacted our ability to conduct business as usual in certain regions inChina , particularlyShanghai . The lockdowns inChina had impacted the demand for certain products, particularly our contact lens and consumer eye care products, as shelter in place orders limit the demand and need for the use of contact lenses and related products. Our revenues inChina for the nine months endedSeptember 30, 2022 and 2021 were$251 million and$277 million , respectively, a decrease of$26 million and, in part, reflects the challenges created by the surge of the omicron variant inChina . During the third quarter of 2022, the impact on our revenues from the headwinds fromChina's COVID-19 policies and lockdowns that we saw during the first half of 2022 began to normalize and we began to see growth in volumes in this region. Additionally, government enforced lockdowns have caused certain businesses to suspend operations, creating distribution and other logistic issues for the distribution of our products and the sourcing for a limited number of raw materials. Through the date of this filing, we have dealt with these issues inChina with only a minimal impact on our manufacturing and distribution processes. However, as the impacts of global reaction to the COVID-19 pandemic remains a fluid situation, we continue to monitor the impacts on our businesses of the COVID-19 virus and variant and subvariant strains thereof in order to timely address new issues if and when they arise. For a further discussion of these and other COVID-19 related risks, see "Risk Factors- Risks Relating to COVID-19" included inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating toBausch + Lomb's Registration Statement on Form S-1 and inBausch + Lomb's supplemented PREP prospectus as filed with the CSA onMay 5, 2022 . Inflation and Supply Chain As a result of global macroeconomic conditions, including, but not limited to those caused by the Russia-Ukraine War and the COVID-19 pandemic, we have been experiencing inflationary pressures related to certain materials for our products. 38 -------------------------------------------------------------------------------- We have also been experiencing certain supply-chain challenges which have caused disruptions in availability and delays in shipping, which has led to challenges in meeting end market demand. These inflationary pressures and supply-chain challenges have impacted our revenues and resulting margins, despite our effort to manage these impacts through strategic pricing actions and other initiatives. While we expect these inflationary pressures and supply-chain challenges to continue through 2022, the duration and extent of these challenges is uncertain and could have an adverse impact on results of operations. We will continue to monitor these inflationary and supply-chain challenges and are implementing actions to help mitigate these challenges. Inflation Reduction Act OnAugust 16, 2022 , US PresidentJoseph Biden signed the Inflation Reduction Act (the "IRA") into law, which includes implementation of a new alternative minimum tax, an excise tax on stock buybacks, and significant tax incentives for energy and climate initiatives, among other provisions. The corporate alternative minimum tax ("CAMT") imposes a minimum tax on the adjusted financial statement income ("AFSI") for "applicable corporations" with average annual AFSI over a three-year period in excess of$1 billion . A corporation that is a member of a foreign-parented multinational group, as defined in the IRA, must include the AFSI (with certain modifications) of all members of the group in applying the$1 billion test, but would only be subject to CAMT if the three-year average AFSI of its US members, US trades or business of foreign group members that are not subsidiaries of US members, and foreign subsidiaries of US members exceeds$100 million . The Company is currently considered a member of BHC's foreign-parented multinational group and the Company's "applicable corporations" would be combined with that of BHC's "applicable corporations" to determine the applicability of the CAMT. The Company currently does not believe this will have a significant impact on its tax results, but will continue to evaluate the law and its potential impacts.
Global Minimum Corporate Tax Rate
OnOctober 8, 2021 , theOrganisation for Economic Co-operation and Development ("OECD")/G20 inclusive framework on Base Erosion and Profit Shifting (the "Inclusive Framework") published a statement updating and finalizing the key components of a two-pillar plan on global tax reform originally agreed onJuly 1, 2021 , and a timetable for implementation by 2023. The timetable for implementation has since been extended to 2024. The Inclusive Framework plan has now been agreed to by 141OECD members, including several countries which did not agree to the initial plan. Under pillar one, a portion of the residual profits of multinational businesses with global turnover above €20 billion and a profit margin above 10% will be allocated to market countries where such allocated profits would be taxed. Under pillar two, the Inclusive Framework has agreed on a global minimum corporate tax rate of 15% for companies with revenue above €750 million, calculated on a country-by-country basis. OnOctober 30, 2021 , theG20 formally endorsed the new global minimum corporate tax rate rules. The Inclusive Framework agreement must now be implemented by the OECD Members who have agreed to the plan, effective in 2024. OnDecember 20, 2021 , theOECD published model rules to implement the pillar two rules, which are generally consistent with the agreement reached by the Inclusive Framework inOctober 2021 . Some further guidance on the plan and the related rules has been published, with additional guidance expected to be published in 2023. We will continue to monitor the implementation of the Inclusive Framework agreement by the countries in which we operate. While we are unable to predict when and how the Inclusive Framework agreement will be enacted into law in these countries, and it is possible that the implementation of the Inclusive Framework agreement, including the global minimum corporate tax rate could have a material effect on our liability for corporate taxes and our consolidated effective tax rate.
Health Care Reform
TheU.S. federal and state governments continue to propose and pass legislation designed to regulate the health care industry. InMarch 2010 , the Patient Protection and Affordable Care Act (the "ACA") was enacted in theU.S. The ACA contains several provisions that impact our business, including: (i) an increase in the minimum Medicaid rebate to states participating in the Medicaid program, (ii) the extension of the Medicaid rebates to Managed Care Organizations that dispense drugs to Medicaid beneficiaries, (iii) the expansion of the 340(B) Public Health Services Act drug pricing program, which provides outpatient drugs at reduced rates, to include additional hospitals, clinics and health care centers and (iv) a fee payable to the federal government based on our prior-calendar-year share relative to other companies of branded prescription drug sales to specified government programs. In addition, in 2013 federal subsidies began to be phased in for brand-name prescription drugs filled in the Medicare Part D coverage gap. The ACA also included provisions designed to increase the number of Americans covered by health insurance. In 2014, the ACA's private health insurance exchanges began to operate. The ACA also allows states to expand Medicaid coverage with most of the expansion's cost paid for by the federal government.
For 2021 and 2020, we incurred costs of
related to the annual fee assessed on prescription drug manufacturers and
importers that sell branded prescription drugs to specified
programs (e.g., Medicare and Medicaid). For 2021 and 2020, we also incurred
costs of
39 -------------------------------------------------------------------------------- Medicare Part D utilization incurred by beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the "donut hole"). The financial impact of the ACA will be affected by certain additional developments over the next few years, including pending implementation guidance and certain health care reform proposals. Additionally, policy efforts designed specifically to reduce patient out-of-pocket costs for medicines could result in new mandatory rebates and discounts or other pricing restrictions. Also, it is possible, as discussed further below, that legislation will be passed byCongress repealing the ACA in whole or in part. Adoption of legislation at the federal or state level could materially affect demand for, or pricing of, our products. Beginning in 2011, the law imposed a significant annual fee on companies that manufacture or import branded prescription drug products. More recently, the Bipartisan Budget Act of 2018 amended the ACA, effectiveJanuary 1, 2019 , to close the donut hole in most Medicare drug plans. In addition, inApril 2018 , theCenters for Medicare & Medicaid Services published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces. In 2018, we faced uncertainties due to federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the ACA. However, we believe there is low likelihood of repeal of the ACA, given the recent failure of theSenate's multiple attempts to repeal various combinations of ACA provisions and the change in theU.S. Presidential administration. There is no assurance that any replacement or administrative modifications of the ACA will not adversely affect our business and financial results, particularly if the replacing legislation reduces incentives for employer-sponsored insurance coverage, and we cannot predict how future federal or state legislative or administrative changes relating to the reform will affect our business. In 2019, theU.S. Department of Health and Human Services announced a preliminary plan to allow for the importation of certain lower-cost drugs fromCanada . The preliminary plan excludes insulin, biological drugs, controlled substances and intravenous drugs. The preliminary plan relies on individual states to develop proposals for safe importation of those drugs fromCanada and submit those proposals to the federal government for approval. Although the preliminary plan has some support from the prior administration, at this time, studies to evaluate the related costs and benefits, evaluate the reasonableness of the logistics, and measure the public reaction of such a plan have not been performed. While we do not believe this will have a significant impact on our future cash flows, we cannot provide assurance as to the effect or impact of such a plan. In 2019, theGovernment of Canada (Health Canada ) published in theCanada Gazette the new pricing regulation for patented drugs. These regulations were scheduled to become effective onJuly 1, 2021 , but were delayed toJuly 1, 2022 . The new regulations, among other things, change the mechanics of establishing the pricing for products submitted for approval afterAugust 21, 2019 and the number and composition of reference countries used to determine if a drug's price is excessive. While we do not believe this will have a significant impact on our future cash flows, as additional facts materialize, we cannot provide assurance as to the ultimate content, timing, effect or impact of such regulations. InJuly 2020 , formerU.S. PresidentDonald Trump signed four Executive Orders related to drug pricing, including orders addressing: (i) Part D rebate reform, (ii) the provision of deeply discounted insulin and/or an EpiPen to patients of Federally Qualified Health Centers, (iii) drug importation fromCanada and (iv) most favored nation pricing for Medicare. InNovember 2020 , formerU.S. PresidentDonald Trump announced the Most Favored Nation Model for Medicare Part B Payment which was to be implemented by theCenter for Medicare & Medicaid Services Innovation onJanuary 1, 2021 ; however, it has not been implemented, as it is currently being challenged in court. It is also uncertain whether the Biden administration intends to reverse these measures or adopt similar policy initiatives. However,U.S. PresidentJoseph Biden and several members of the currentU.S. Congress have indicated that lowering drug prices is a legislative and political priority, and some have introduced proposals that seek to address drug pricing. InDecember 2020 , as part of a series of drug pricing-related rules issued by theTrump Administration , theCenter for Medicare & Medicaid Services issued a Final Rule that makes significant modifications to the Medicaid Drug Rebate Program regulations in several areas, including with respect to the definition of key terms "line extension" and "new formulation" and best price (BP) reporting relating to certain value-based purchasing (VBP) arrangements (which took effect onJanuary 1, 2022 ) and the price reporting treatment of manufacturer-sponsored patient benefit programs (which take effect onJanuary 1, 2023 ).
In
One of the provisions included within the American Rescue Plan Act of 2021
eliminated the Maximum Rebate Amount for
Multiple Source drugs in the Medicaid Drug Rebate Program. We are currently
reviewing the legislation, the impact of which is uncertain at this time.
40 -------------------------------------------------------------------------------- Other legislative efforts relating to drug pricing have been enacted and others have been proposed at theU.S. federal and state levels. For instance, certain states have enacted legislation related to prescription drug pricing transparency. Several states have passed importation legislation andFlorida is working with theU.S. government to implement an importation program fromCanada . We also anticipate thatCongress , state legislatures and third-party payors may continue to review and assess alternative health care delivery and payment systems and may in the future propose and adopt legislation or policy changes or implementations affecting additional fundamental changes in the health care delivery system. We continually review newly enacted and proposedU.S. federal and state legislation, as well as proposed rulemaking and guidance published by theU.S. Department of Health and Human Services and the FDA; however, at this time, it is unclear the effect these matters may have on our businesses.
Certain of our products face the expiration of their patent or regulatory exclusivity in 2022 or in later years, following which we anticipate generic competition of these products. In addition, in certain cases, as a result of negotiated settlements of some of our patent infringement proceedings against generic competitors, we have granted licenses to such generic companies, which will permit them to enter the market with their generic products prior to the expiration of our applicable patent or regulatory exclusivity. Finally, for certain of our products that lost patent or regulatory exclusivity in prior years, we anticipate that generic competitors may launch in 2022 or in later years. Following a loss of exclusivity ("LOE") of and/or generic competition for a product, we would anticipate that product sales for such product would decrease significantly shortly following the LOE or entry of a generic competitor. Where we have the rights, we may elect to launch an authorized generic ("AG") of such product (either ourselves or through a third-party) prior to, upon or following generic entry, which may mitigate the anticipated decrease in product sales; however, even with launch of an authorized generic, the decline in product sales of such product would still be expected to be significant, and the effect on our future revenues could be material. Certain of our products already face generic competition. During 2021, products that began facing LOE in theU.S. included, Lotemax® Gel and Bepreve®, which in aggregate accounted for less than 1% of our total revenues in 2021. Based on current patent expiration dates, settlement agreements and/or competitive information, we have also identified branded products that we believe could begin facing potential LOE and/or generic competition in theU.S. over the next five years, which in the aggregate accounted for approximately 1% of our total revenues in 2021. This could change based on, among other things, successful challenge to our patents, settlement of existing or future patent litigation and at-risk generic launches. We believe the entry into the market of generic competition generally would have an adverse impact on the volume and/or pricing of the affected products, however we are unable to predict the magnitude or timing of this impact. In addition, the PreserVision®U.S. formulation patent expired inMarch 2021 , but a patent covering methods of using the formulation remains in force into 2026. PreserVision® products accounted for approximately 6% of our total revenues in 2021. PreserVision® is (or was) the subject of certain ongoing and past patent infringement proceedings. While the Company cannot predict the magnitude or timing of the impact from the PreserVision® patent expiry, this is an OTC product and thus, the impact is not expected to be as significant as the LOE of a branded pharmaceutical product. In addition, in connection with our Lumify®, PreserVision® and Vyzulta® products, we have commenced ongoing infringement proceedings (or anticipate commencing infringement proceedings) against potential generic competitors in theU.S. If we are not successful in these proceedings, we may face increased generic competition for these products. See Note 18, "LEGAL PROCEEDINGS" to our unaudited interim Condensed Consolidated Financial Statements, as well as Note 18, "LEGAL PROCEEDINGS" of our Combined Financial Statements for the year endedDecember 31, 2021 , which are included inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating toBausch + Lomb's Registration Statement on Form S-1 andBausch + Lomb's supplemented PREP prospectus filed with the CSA onMay 5, 2022 , for further details regarding certain of these infringement proceedings. The risks of generic competition are a fact of the eye health industry and are not specific to our operations or product portfolio. These risks are not avoidable, but we believe they are manageable. To manage these risks, our leadership team continually evaluates the impact that generic competition may have on future profitability and operations. In addition to aggressively defending our patents and other intellectual property, our leadership team makes operational and investment decisions regarding these products and businesses at risk, not the least of which are decisions regarding our pipeline. Our leadership team actively manages our pipeline in order to identify innovative and realizable projects that are expected to provide incremental and sustainable revenues and growth into the future. We believe that we have a well-established product portfolio that is diversified within our core businesses. We also believe that we have a robust pipeline that not only provides for the next generation of our existing products, but also brings new solutions into the market. 41 -------------------------------------------------------------------------------- See the section entitled "Risk Factors" included inBausch + Lomb's final prospectus as filed with theSEC onMay 5, 2022 pursuant to Rule 424(b)(4) under the Act relating toBausch + Lomb's Registration Statement on Form S-1 and inBausch + Lomb's supplemented PREP prospectus as filed with the CSA onMay 5, 2022 , for additional information on the risks associated with our intellectual property and our competition risks.
Regulatory Matters
In the normal course of business, our products, devices and facilities are the subject of ongoing oversight and review by regulatory and governmental agencies, including general, for cause and pre-approval inspections by the relevant competent authorities where we have business operations. Through the date of this filing, all of our global operations and facilities have the relevant operational good manufacturing practices certificates and all of our products and operating sites are in good compliance standing with all relevant notified bodies and global health authorities. Further, all sites under FDA jurisdiction are rated as either No Action Indicated (where there was no Form 483 observation) or Voluntary Action Indicated ("VAI") (where there was a Form 483 with one or more observations). In the case of VAI inspection outcomes, the FDA has accepted our responses to the issues cited, which will be verified when the agency makes its next inspection of those specific facilities.
FINANCIAL PERFORMANCE HIGHLIGHTS
OnApril 28, 2022 ,Bausch + Lomb effected a share consolidation as a result of which it had 350,000,000 issued and outstanding common shares. These common shares are treated as issued and outstanding atJanuary 1, 2021 for purposes of calculating Basic and diluted (loss) income per share attributable toBausch + Lomb Corporation . The following table provides selected unaudited financial information for the three and nine months endedSeptember 30, 2022 and 2021: Three Months Ended September 30, Nine Months Ended September 30, (in millions, except per share data) 2022 2021 Change 2022 2021 Change Revenues$ 942 $ 949 $ (7) $ 2,772 $ 2,764 $ 8 Operating income $ 46$ 94
Income before provision for income taxes $ 19
Net (loss) income attributable to
+ Lomb Corporation
$ (18) $ 60 $ (78) $ 7$ 131 $ (124) Basic and diluted (loss) income per share attributable to Bausch + Lomb Corporation$ (0.05) $ 0.17 $ (0.22) $ 0.02 $ 0.37 $ (0.35) Financial Performance
Summary of the Three Months Ended
Months Ended
Revenues for the three months endedSeptember 30, 2022 and 2021 were$942 million and$949 million , respectively, a decrease of$7 million , or 1%. The decrease was primarily attributable to the unfavorable impact of foreign currencies across all our international businesses. This decrease was partially offset by increases in: (i) volumes across each of our segments and (ii) net realized pricing, primarily in our Vision Care segment. Operating income for the three months endedSeptember 30, 2022 and 2021 was$46 million and$94 million , respectively, a decrease of$48 million which reflects, among other factors: •a decrease in contribution (product sales revenue less cost of goods sold, exclusive of amortization and impairments of intangible assets) of$13 million , primarily driven by: (i) the unfavorable impact of foreign currencies and (ii) higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of our Daily SiHy lenses, partially offset by the increase in pricing; •an increase in selling, general and administrative ("SG&A") expenses of$33 million , primarily attributable to: (i) higher professional fees and higher compensation expenses, primarily related to separation-related costs and dis-synergy costs associated with the Company becoming a stand-alone entity and (ii) higher selling expenses, partially offset by the favorable impact of foreign currencies;
•an increase in R&D of
regulation costs;
•a decrease in Amortization of intangible assets of
to fully amortized intangible assets no longer being amortized in 2022; and
•a decrease in Other expense, net of$1 million , primarily due to lower asset impairment charges, partially offset by higher restructuring, integration and separation costs. 42 --------------------------------------------------------------------------------
Operating income for the three months ended
million
Depreciation and amortization of intangible assets of
million
respectively.
Income before provision for income taxes for the three months endedSeptember 30, 2022 and 2021 was$19 million and$88 million , respectively, a decrease of$69 million and is primarily attributable to: (i) the decrease in our operating results of$48 million , as previously discussed and (ii) an increase in interest expense of$35 million , partially offset by a favorable net change in Foreign exchange and other of$12 million . Net loss attributable toBausch + Lomb for the three months endedSeptember 30, 2022 was$18 million , as compared to Net income attributable toBausch + Lomb for the three months endedSeptember 30, 2021 of$60 million , a decrease in our results of$78 million and was primarily due to the decreases in Income before provision for income taxes of$69 million , as previously discussed, partially offset by a decrease in the Provision for income taxes of$9 million .
Summary of the Nine Months Ended
Ended
Revenues for the nine months endedSeptember 30, 2022 and 2021 were$2,772 million and$2,764 million , respectively, an increase of$8 million . The increase was attributable to: (i) increases in volumes in each of our segments and (ii) an increase in net realized pricing in our Vision Care segment, partially offset by decreases in net realized pricing in ourOphthalmic Pharmaceuticals segment. These increases were also partially offset by: (i) the unfavorable impact of foreign currencies across all our international businesses and (ii) the impact of divestitures and discontinuations.
Operating income for the nine months ended
million
reflects, among other factors:
•a decrease in contribution (product sales revenue less cost of goods sold, exclusive of amortization and impairments of intangible assets) of$25 million , primarily driven by: (i) higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of our Daily SiHy lenses and (ii) year-over-year changes in product mix. The higher manufacturing variances were partially offset by the non-recurrence of prior year charges related to a quality issue at a third-party supplier, as discussed below; •an increase in SG&A expenses of$68 million , primarily attributable to: (i) higher professional fees and higher compensation expenses, primarily related to separation-related costs and dis-synergy costs associated with the Company becoming a stand-alone entity and (ii) higher selling expenses, primarily related to freight, partially offset by the favorable impact of foreign currencies;
•an increase in R&D of
regulation costs;
•a decrease in Amortization of intangible assets of
to fully amortized intangible assets no longer being amortized in 2022; and
•a decrease in Other expense, net of
asset impairment charges and (ii) a fair value adjustment related to
acquisition-related contingent consideration, partially offset by higher
restructuring, integration and separation costs.
Operating income for the nine months ended
million
Depreciation and amortization of intangible assets of
million
respectively.
Income before provision for income taxes for the nine months endedSeptember 30, 2022 and 2021 was$75 million and$232 million , respectively, a decrease of$157 million and is primarily attributable to: (i) an increase in interest expense of$99 million and (ii) the decrease in our operating results of$81 million , as previously discussed, partially offset by a favorable net change in Foreign exchange and other of$20 million . Net income attributable toBausch + Lomb for the nine months endedSeptember 30, 2022 was$7 million , as compared to Net income attributable toBausch + Lomb for the nine months endedSeptember 30, 2021 of$131 million , a decrease in our results of$124 million and was primarily due to the decreases in Income before provision for income taxes of$157 million , as previously discussed, partially offset by a decrease in the Provision for income taxes of$33 million . 43 --------------------------------------------------------------------------------
RESULTS OF OPERATIONS
Our unaudited operating results for the three and nine months ended
30, 2022
Three Months Ended Nine Months Ended September 30, September 30, (in millions) 2022 2021 Change 2022 2021 Change Revenues Product sales$ 937 $ 941 $ (4) $ 2,755 $ 2,743 $ 12 Other revenues 5 8 (3) 17 21 (4) 942 949 (7) 2,772 2,764 8 Expenses Cost of goods sold (excluding amortization and impairments of intangible assets) (Note 4) 370 361 9 1,093 1,056 37 Cost of other revenues 2 3 (1) 6 8 (2) Selling, general and administrative (Note 4) 381 348 33 1,092 1,024 68 Research and development (Note 4) 77 63 14 229 201 28 Amortization of intangible assets 59 72 (13) 188 225 (37) Other expense, net 7 8 (1) 8 13 (5) 896 855 41 2,616 2,527 89 Operating income 46 94 (48) 156 237 (81) Interest income 2 - 2 3 - 3 Interest expense (Note 4) (35) - (35) (99) - (99) Foreign exchange and other 6 (6) 12 15 (5) 20 Income before provision for income taxes 19 88 (69) 75 232 (157) Provision for income taxes (34) (25) (9) (60) (93) 33 Net (loss) income (15) 63 (78) 15 139 (124) Net income attributable to noncontrolling interest (3) (3) - (8) (8) - Net (loss) income attributable to Bausch + Lomb Corporation$ (18) $ 60
Three Months Ended
Revenues
Our revenues are primarily generated from product sales in the therapeutic areas of eye health that consist of: (i) branded prescription eye-medications and pharmaceuticals, (ii) generic and branded generic prescription eye medications and pharmaceuticals, (iii) OTC vitamin and supplement products and (iv) medical devices (contact lenses, intraocular lenses and ophthalmic surgical equipment). Other revenues include alliance and service revenue from the licensing and co-promotion of products and contract service revenue. Contract service revenue is derived primarily from contract manufacturing for third parties and is not material. Our revenues were$942 million and$949 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$7 million , or 1%. The decrease was attributable to: (i) the unfavorable impact of foreign currencies across all our international businesses of$55 million primarily inEurope andAsia and (ii) the impact of divestitures and discontinuations of$1 million , related to the discontinuation of certain products. These decreases were partially offset by increases in: (i) volumes of$25 million and (ii) net realized pricing of$24 million , primarily within our Vision Care segment. The increase in volumes was due to: (i) new launches within our international contact lens business, (ii) increased demand of consumables and IOLs within our Surgical segment and (iii) increased demand and new launches within ourOphthalmic Pharmaceuticals segment.
The changes in our segment revenues and segment profits for the three months
ended
subsequent sections titled “-Reportable Segment Revenues and Profits.”
Cash Discounts and Allowances, Chargebacks and Distribution Fees
As is customary in the health care industry, gross product sales are subject to a variety of deductions in arriving at net product sales. Provisions for these deductions are recognized concurrently with the recognition of gross product sales. These provisions include cash discounts and allowances, chargebacks, and distribution fees, which are paid or credited to direct 44 -------------------------------------------------------------------------------- customers, as well as rebates and returns, which can be paid or credited to direct and indirect customers. Provision balances relating to amounts payable to direct customers are netted against trade receivables and balances relating to indirect customers are included in accrued liabilities. We actively manage these offerings, focusing on the incremental costs of our patient assistance programs, the level of discounting to non-retail accounts and identifying opportunities to minimize product returns. We also concentrate on managing our relationships with our payors and wholesalers, reviewing the ranges of our offerings and being disciplined as to the amount and type of incentives we negotiate. Provisions recorded to reduce gross product sales to net product sales and revenues for the three months endedSeptember 30, 2022 and 2021 were as follows:
Three Months Ended
2022 2021 (in millions) Amount Pct. Amount Pct. Gross product sales$ 1,297 100.0 %$ 1,268 100.0 % Provisions to reduce gross product sales to net product sales Discounts and allowances 85 6.60 % 87 6.90 % Returns 17 1.30 % 13 0.90 % Rebates 133 10.30 % 133 10.50 % Chargebacks 119 9.10 % 90 7.10 % Distribution fees 6 0.50 % 4 0.40 % Total provisions 360 27.80 % 327 25.80 % Net product sales 937 72.20 % 941 74.20 % Other revenues 5 8 Revenues$ 942 $ 949 Cash discounts and allowances, returns, rebates, chargebacks and distribution fees as a percentage of gross product sales were 27.8% and 25.8% for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of 2.0% percentage points, and is primarily attributable to the increase in chargebacks as a percentage of revenues. Chargebacks were$119 million and$90 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$29 million . The increase in chargebacks is primarily attributable to our generics portfolio as a result of product and customer mix and lower contract pricing due to increased competition on certain products.
Operating Expenses
Cost of Goods Sold (exclusive of amortization and impairments of intangible
assets)
Cost of goods sold primarily includes: manufacturing and packaging; the cost of products we purchase from third parties; royalty payments we make to third parties; depreciation of manufacturing facilities and equipment; and lower of cost or market adjustments to inventories. Cost of goods sold typically vary between periods as a result of product mix, volume, royalties, changes in foreign currency and inflation. Cost of goods sold excludes the amortization and impairments of intangible assets. Cost of goods sold was$370 million and$361 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$9 million , or 2%. The increase was primarily driven by: (i) higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of our Daily SiHy lenses and (ii) higher volumes, as previously discussed, partially offset by the favorable impact of foreign currencies. We continue to monitor the impact of inflationary pressures on our operating results, particularly on our manufacturing costs, and we expect higher year over year manufacturing variances for the remainder of 2022 as a result of inflation. Cost of goods sold as a percentage of Product sales was 39.5% and 38.4% for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of 1%, primarily as a result of inflationary pressures related to certain manufacturing costs, partially offset by the increase in net realized pricing.
Selling, General and Administrative Expenses
SG&A expenses primarily include: employee compensation associated with sales and marketing, finance, legal, information technology, human resources and other administrative functions; certain outside legal fees and consultancy costs; product promotion expenses; overhead and occupancy costs; depreciation of corporate facilities and equipment; and other general and administrative costs. In connection with the Separation, the Company has also incurred, and expects to continue 45 --------------------------------------------------------------------------------
to incur separation and separation-related costs associated with activities
taken to: (i) separate the
(ii) register the
entity
SG&A expenses were$381 million and$348 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$33 million , or 9%. The increase was primarily attributable to: (i) higher professional fees and higher compensation expenses, primarily related to separation-related costs and dis-synergy costs associated with the Company becoming a stand-alone entity and (ii) higher selling expenses, primarily related to freight, partially offset by the favorable impact of foreign currencies.
Research and Development Expenses
Included in R&D are costs related to our product development and quality assurance programs. Expenses related to product development include: employee compensation costs; overhead and occupancy costs; depreciation of research and development facilities and equipment; clinical trial costs; clinical manufacturing and scale-up costs; and other third-party development costs. Quality assurance are the costs incurred to meet evolving customer and regulatory standards and include: employee compensation costs; overhead and occupancy costs; amortization of software; and other third-party costs. R&D expenses were$77 million and$63 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$14 million , or 22%. R&D expenses as a percentage of Product sales were approximately 8.0% and 7.0% for the three months endedSeptember 30, 2022 and 2021, respectively. The increase in R&D expenses is primarily due to higher medical device regulation costs.
Amortization of Intangible Assets
Intangible assets with finite lives are amortized using the straight-line method
over their estimated useful lives, generally 1 to 17 years. Management
continually assesses the useful lives related to our long-lived assets to
reflect the most current assumptions.
Amortization of Intangible assets was
months ended
million
amortized in 2022.
See Note 8, “INTANGIBLE ASSETS AND GOODWILL” to our unaudited interim Condensed
Consolidated Financial Statements for further details related to the
Amortization of intangible assets.
Other expense, net
Other expense, net for the three months ended
consists of the following:
Three Months Ended September 30, (in millions) 2022 2021 Asset impairments $ 1$ 8 Restructuring, integration and separation costs 5 - Acquired in-process research and development costs 1 - Other expense, net $ 7$ 8
Non-Operating Income and Expense
Interest Expense
Interest expense primarily consists of interest payments due, amortization of
debt discounts and deferred issuance costs on indebtedness under our credit
facilities and interest previously due on a promissory note to BHC.
Interest expense was$35 million and$0 for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$35 million . The increase is primarily attributable to interest associated with the Term Facility (as defined and discussed in further detail, under Item "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt") entered intoMay 2022 . See Note 10, "CREDIT FACILITIES" to our unaudited interim Condensed Consolidated Financial Statements for further details regarding the Term Facility. 46 --------------------------------------------------------------------------------
Foreign Exchange and Other
Foreign exchange and other primarily includes translation gains/losses on intercompany loans and third-party liabilities and the gain/loss due to the change in fair value of foreign currency exchange contracts. Foreign exchange and other was a net gain of$6 million and a loss of$6 million for the three months endedSeptember 30, 2022 and 2021, respectively.
Income Taxes
Provision for income taxes were$34 million and$25 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$9 million . The increase in income taxes was primarily related to: (i) a change in the jurisdictional mix of earnings and (ii) discrete tax effects of: (a) changes in uncertain tax positions, (b) the filing of certain tax returns and (c) a change in the deduction for stock compensation.
See Note 16, “INCOME TAXES” to our unaudited interim Condensed Consolidated
Financial Statements for further details.
Reportable Segment Revenues and Profits
The following is a brief description of
•The Vision Care segment consists of: (i) sales of contact lenses that span the spectrum of wearing modalities, including daily disposable and frequently replaced contact lenses and (ii) sales of contact lens care products and OTC eye drops, eye vitamins and mineral supplements that address various conditions including eye allergies, conjunctivitis and dry eye. •The Ophthalmic Pharmaceuticals segment consists of sales of a broad line of proprietary and generic pharmaceutical products for post-operative treatments and the treatment of a number of eye conditions such as glaucoma, ocular hypertension and retinal diseases. •The Surgical segment consists of sales of tools and technologies for the treatment of cataracts, and vitreous and retinal eye conditions and includes intraocular lenses and delivery systems, phacoemulsification equipment and other surgical instruments and devices.
Segment profit is based on operating income after the elimination of
intercompany transactions. Certain costs, such as Amortization of intangible
assets and Other (income) expense, net, are not included in the measure of
segment profit, as management excludes these items in assessing segment
financial performance. See Note 19, “SEGMENT INFORMATION” to our unaudited
interim Condensed Consolidated Financial Statements for a reconciliation of
segment profit to Income before provision for income taxes.
The following table presents segment revenues, segment revenues as a percentage of total revenues and the period-over-period changes in segment revenues for the three months endedSeptember 30, 2022 and 2021. The following table also presents segment profits, segment profits as a percentage of segment revenues and the period-over-period changes in segment profits for the three months endedSeptember 30, 2022 and 2021.
Three Months Ended
2022 2021 Change (in millions) Amount Pct. Amount Pct. Amount Pct. Segment Revenues Vision Care$ 598 64 %$ 605 64 %$ (7) (1) % Ophthalmic Pharmaceuticals 172 18 % 171 18 % 1 1 % Surgical 172 18 % 173 18 % (1) (1) % Total revenues$ 942 100 %$ 949 100 %$ (7) (1) % Segment Profits / Segment Profit Margins Vision Care$ 167 28 %$ 145 24 %$ 22 15 % Ophthalmic Pharmaceuticals 50 29 % 74 43 % (24) (32) % Surgical 9 5 % 26 15 % (17) (65) % Total segment profits$ 226 24 %$ 245 26 %$ (19) (8) % 47
--------------------------------------------------------------------------------
Organic Revenues and Organic Growth Rates (non-GAAP)
Organic growth, a non-GAAP measure, is defined as a change on a period-over-period basis in revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations. Organic revenue growth (non-GAAP) is growth in Revenue (its most directly comparable GAAP financial measure), adjusted for certain items, of businesses that have been owned for one or more years. Organic revenue (non-GAAP) is impacted by changes in product volumes and price. The price component is made up of two key drivers: (i) changes in product gross selling price and (ii) changes in sales deductions. The Company uses organic revenue (non-GAAP) and organic revenue growth (non-GAAP) to assess performance of its reportable segments, and the Company in total, without the impact of foreign currency exchange fluctuations and recent acquisitions, divestitures and product discontinuations. The Company believes that such measures are useful to investors as they provide a supplemental period-to-period comparison. Organic revenue growth (non-GAAP) reflects adjustments for: (i) the impact of period-over-period changes in foreign currency exchange rates on revenues and (ii) the revenues associated with acquisitions, divestitures and discontinuations of businesses divested and/or discontinued. These adjustments are determined as follows: Foreign currency exchange rates: Although changes in foreign currency exchange rates are part of our business, they are not within management's control. Changes in foreign currency exchange rates, however, can mask positive or negative trends in the underlying business performance. The impact for changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period. Acquisitions, divestitures and discontinuations: In order to present period-over-period organic revenues (non-GAAP) on a comparable basis, revenues associated with acquisitions, divestitures and discontinuations are adjusted to include only revenues from those businesses and assets owned during both periods. Accordingly, organic revenue growth (non-GAAP) excludes from the current period all revenues attributable to each acquisition for the twelve months subsequent to the day of acquisition, as there are no revenues from those businesses and assets included in the comparable prior period. Organic revenue growth (non-GAAP) excludes from the prior period (but not the current period), all revenues attributable to each divestiture and discontinuance during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period. Non-GAAP financial measures and non-GAAP ratios are not prepared in accordance with GAAP nor do they have any standardized meaning under GAAP. In addition, other companies may use similarly titled non-GAAP financial measures and ratios that are calculated differently from the way we calculate such measures and ratios. Accordingly, the Company's non-GAAP financial measures and ratios may not be comparable to such similarly titled non-GAAP financial measures and ratios used by other companies. The following table presents a reconciliation of Revenues to organic revenues (non-GAAP) and the period-over-period changes in organic revenue (non-GAAP) for the three months endedSeptember 30, 2022 and 2021. Three Months Ended September 30, 2022 Three Months Ended September 30, 2021 Change in Revenue Revenue Organic Revenue (Non-GAAP) as Changes in Organic Revenue as Divestitures Organic Revenue (in millions) Reported Exchange Rates (Non-GAAP) Reported and Discontinuations (Non-GAAP) Amount Pct. Vision Care $ 598 $ 34 $ 632 $ 605 $ - $ 605 $ 27 4 %Ophthalmic Pharmaceuticals 172 8 180 171 - 171 9 5 % Surgical 172 13 185 173 (1) 172 13 8 % Total $ 942 $ 55 $ 997 $ 949 $ (1) $ 948 $ 49 5 % Vision Care Segment: Vision Care Segment Revenue The Vision Care segment revenue was$598 million and$605 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$7 million , or 1%. The decrease was driven by the unfavorable impact of foreign currencies of$34 million , primarily inAsia andEurope . The decrease was partially offset by: (i) an increase in net pricing of$23 million primarily within our consumer eye care business and (ii) an increase in volumes of$4 million , primarily due to new launches within our international contact lens business. Vision Care Segment Profit The Vision Care segment profit was$167 million and$145 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$22 million , or 15%. The increase was primarily driven by: (i) a decrease in R&D expense 48 -------------------------------------------------------------------------------- primarily in ourU.S. contact lens business and (ii) a decrease in SG&A, primarily due to the favorable impact of foreign currencies on the Company's expenses. These decreases were partially offset by higher manufacturing variances, primarily within our contact lens business, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of our Daily SiHy lenses.
Ophthalmic Pharmaceuticals Segment:
Ophthalmic Pharmaceuticals Segment Revenue
The Ophthalmic Pharmaceuticals segment revenue was$172 million and$171 million for the three months endedSeptember 30, 2022 and 2021, respectively, an increase of$1 million , or 1%. The increase was driven by an increase in volumes of$10 million , primarily due to increased demand and new launches. This increase was partially offset by: (i) the unfavorable impact of foreign currencies of$8 million , primarily inEurope and (ii) a decrease in net pricing of$1 million .
Ophthalmic Pharmaceuticals Segment Profit
The Ophthalmic Pharmaceuticals segment profit was$50 million and$74 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$24 million , or 32%. The decrease was primarily driven by: (i) higher R&D expense and (ii) higher advertising and promotional costs due to newly launched products, such as XIPERE® in the first quarter of 2022.
Surgical Segment:
Surgical Segment Revenue
The Surgical segment revenue was$172 million and$173 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$1 million , or 1%. The decrease was driven by the unfavorable effect of foreign currencies of$13 million , primarily inEurope and (ii) the impact of divestitures and discontinuations of$1 million , related to the discontinuation of certain products. These decreases were partially offset by: (i) an increase in volumes of$11 million , primarily due to increased demand of consumables and intraocular lenses and (ii) an increase in net realized pricing of$2 million .
Surgical Segment Profit
The Surgical segment profit was$9 million and$26 million for the three months endedSeptember 30, 2022 and 2021, respectively, a decrease of$17 million , or 65%. The decrease was primarily driven by: (i) higher R&D expense and (ii) higher SG&A expense. 49 --------------------------------------------------------------------------------
Nine Months Ended
30, 2021
Revenues Our revenues were$2,772 million and$2,764 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$8 million , or less than 1%. The increase was attributable to increases in: (i) volumes of$113 million across each of our segments and (ii) net realized pricing of$32 million . The increase in volumes was primarily driven by: (i) our consumer eye care business, driven by: (a) increased demand for Lumify®, Biotrue® and PreserVision® and (b) the non-recurrence of a third-party supplier quality issue on the prior year revenues of certain consumer eye care products, as discussed below, (ii) increased demand of consumables and intraocular lenses within our Surgical segment and (iii) increased demand and new launches within our Ophthalmic Pharmaceuticals Segment. These increases in volume were partially offset by the impact of the COVID-19 pandemic during the first half of the year on our contact lens business inChina . The increases in revenue were partially offset by: (i) the unfavorable impact of foreign currencies across all our international businesses of$130 million , primarily inEurope andAsia , and (ii) the impact of divestitures and discontinuations of$7 million , related to the discontinuation of certain products.
The changes in our segment revenues and segment profits for the nine months
ended
subsequent sections titled “-Reportable Segment Revenues and Profits.”
Cash Discounts and Allowances, Chargebacks and Distribution Fees
Provisions recorded to reduce gross product sales to net product sales and
revenues for the nine months ended
Nine Months Ended
2022 2021 (in millions) Amount Pct. Amount Pct. Gross product sales$ 3,802 100.0 %$ 3,696 100.0 % Provisions to reduce gross product sales to net product sales Discounts and allowances 245 6.40 % 250 6.80 % Returns 52 1.40 % 58 1.60 % Rebates 403 10.60 % 389 10.50 % Chargebacks 330 8.70 % 243 6.50 % Distribution fees 17 0.40 % 13 0.40 % Total provisions 1,047 27.50 % 953 25.80 % Net product sales 2,755 72.50 % 2,743 74.20 % Other revenues 17 21 Revenues$ 2,772 $ 2,764 Cash discounts and allowances, returns, rebates, chargebacks and distribution fees as a percentage of gross product sales were 27.5% and 25.8% for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of 1.7 percentage points, and is primarily attributable to the increase in chargebacks as a percentage of revenues. Chargebacks were$330 million and$243 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$87 million . The increase in chargebacks is primarily attributable to our generics portfolio as a result of product and customer mix and lower contract pricing due to increased competition on certain products.
Operating Expenses
Cost of Goods Sold (exclusive of amortization and impairments of intangible
assets)
Cost of goods sold was$1,093 million and$1,056 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$37 million , or 4%. The increase was primarily driven by: (i) higher volumes, as previously discussed and (ii) higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of our Daily SiHy lenses, partially offset by the favorable impact of foreign currencies. The higher manufacturing variances were partially offset by the non-recurrence of prior year charges related to a quality issue at a third-party supplier, as discussed below. We continue to monitor the impact of inflationary pressures on our operating results, particularly on our manufacturing costs, and we expect higher year over year manufacturing variances for the remainder of 2022 as a result of inflation. 50 -------------------------------------------------------------------------------- In 2021, we were notified by a third-party supplier of sterilization services for our lens care solution bottles and caps at ourMilan, Italy facility, of inconsistencies in the sterilization data versus certificates of conformance previously submitted to us by that supplier. Based on our internal Health and Safety Analysis, it was determined that this issue did not affect the safety or performance of any of our products and was limited to a specific number of lots for certain consumer eye care products within our Vision Care segment. However, out of an abundance of caution and working with the appropriate notified body and responsible health authorities, we contained and/or recalled down to the consumer level the limited number of affected lots of products resulting in$8 million of manufacturing variances and$6 million of returns during the nine months endedSeptember 30, 2021 . Further, although ourGreenville, South Carolina facility increased production to support some of the demand in the near term, due to the limited availability of qualified materials, production at theMilan facility could not keep up with demand which negatively impacted our sales for the affected products in this region during the nine months endedSeptember 30, 2021 . During the third quarter of 2021, we had removed this supplier from our Approved Supplier List and qualified another sterilization supplier, who, along with an existing secondary supplier, will provide bottle sterilization, thereby allowing ourMilan facility to return to full production capacity. Cost of goods sold as a percentage of Product sales was 39.7% and 38.5% for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of 1.2% primarily attributable to: (i) higher manufacturing variances and (ii) year-over-year changes in product mix.
Selling, General and Administrative Expenses
SG&A expenses were$1,092 million and$1,024 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$68 million , or 7%. The increase was primarily attributable to: (i) higher professional fees and higher compensation expenses, primarily related to separation-related costs and dis-synergy costs associated with the Company becoming a stand-alone entity and (ii) higher selling expenses, primarily related to freight, partially offset by the favorable impact of foreign currencies.
Research and Development Expenses
R&D expenses were$229 million and$201 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$28 million , or 14%. The increase in R&D expenses is primarily due to higher medical device regulation costs and due to R&D spend not beginning to normalize until the second half of 2021, as a result of the COVID-19 pandemic, as discussed below. R&D expenses as a percentage of Product sales were approximately 8% and 7% for the nine months endedSeptember 30, 2022 and 2021, respectively. In 2020, certain of our R&D activities were limited and others, including new patient enrollments in clinical trials, were temporarily paused, as most trial sites were not able to accept new patients due to government-mandated shutdowns in response to the COVID-19 pandemic. During our third quarter of 2020, many of these trial sites began to reopen and the pace of new patient enrollments increased heading into 2021. During 2021, these activities and related R&D spend gradually increased until they approached a normalized spend rate toward the end of the year. As of the date of this filing, we have not had to make material changes to our development timelines and the pause in our clinical trials has not had a material impact on our operating results; however, a resurgence of the virus could result in unanticipated delays in our ability to conduct new patient enrollments and create other delays which could have a significant adverse effect on our future operating results.
Amortization of Intangible Assets
Amortization of Intangible assets was
months ended
million
amortized in 2022.
See Note 8, “INTANGIBLE ASSETS AND GOODWILL” to our unaudited interim Condensed
Consolidated Financial Statements for further details related to the
Amortization of intangible assets.
51 --------------------------------------------------------------------------------
Other expense, net
Other expense, net for the nine months ended
consists of the following:
Nine Months Ended September 30, (in millions) 2022 2021 Asset impairments $ 1$ 11 Restructuring, integration and separation costs 11 1 Acquired in-process research and development costs 1 1 Acquisition-related contingent consideration (5) - Other expense, net $ 8$ 13
Non-Operating Income and Expense
Interest Expense
Interest expense was$99 million and$0 for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$99 million . The increase is primarily attributable to interest associated with: (i) the Term Facility (as defined and discussed in further detail, under Item "- Liquidity and Capital Resources - Liquidity and Debt - Long-term Debt") entered intoMay 2022 and (ii) BHC Purchase Debt (as defined below) entered into inJanuary 2022 . See Note 10, "CREDIT FACILITIES" to our unaudited interim Condensed Consolidated Financial Statements for further details regarding the Term Facility. OnJanuary 1, 2022 , in anticipation of the B+L IPO,Bausch + Lomb issued a$2,200 million promissory note to BHC (the "BHC Purchase Debt") in conjunction with a legal reorganization. Included in Interest expense for the nine months endedSeptember 30, 2022 was$47 million of interest attributed to the BHC Purchase Debt. The BHC Purchase Debt was repaid in full onMay 10, 2022 . See Note 4, "RELATED PARTIES" to our unaudited interim Condensed Consolidated Financial Statements for further details.
Foreign Exchange and Other
Foreign exchange and other was a net gain of
million
Income Taxes
Provision for income taxes were$60 million and$93 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a favorable change of$33 million . The decrease in income taxes was primarily related to: (i) a change in the jurisdictional mix of earnings and (ii) discrete tax effects of: (a) internal restructurings in 2021, (b) changes in uncertain tax positions, (c) the filings of certain tax returns and (d) a change in the deduction for stock compensation.
See Note 16, “INCOME TAXES” to our unaudited interim Condensed Consolidated
Financial Statements for further details.
52 --------------------------------------------------------------------------------
Reportable Segment Revenues and Profits
The following table presents segment revenues, segment revenues as a percentage of total revenues and the period-over-period changes in segment revenues for the nine months endedSeptember 30, 2022 and 2021. The following table also presents segment profits, segment profits as a percentage of segment revenues and the period-over-period changes in segment profits for the nine months endedSeptember 30, 2022 and 2021.
Nine Months Ended
2022 2021 Change (in millions) Amount Pct. Amount Pct. Amount Pct. Segment Revenues Vision Care$ 1,747 63 %$ 1,717 62 %$ 30 2 % Ophthalmic Pharmaceuticals 495 18 % 527 19 % (32) (6) % Surgical 530 19 % 520 19 % 10 2 % Total revenues$ 2,772 100 %$ 2,764 100 %$ 8 - % Segment Profits / Segment Profit Margins Vision Care$ 471 27 %$ 431 25 %$ 40 9 % Ophthalmic Pharmaceuticals 142 29 % 208 39 % (66) (32) % Surgical 35 7 % 55 11 % (20) (36) % Total segment profits$ 648 23 %$ 694 25 %$ (46) (7) % The following table presents a reconciliation of Revenues to organic revenues (non-GAAP) and the period-over-period changes in organic revenue (non-GAAP) for the nine months endedSeptember 30, 2022 and 2021. Organic revenues (non-GAAP) and organic growth (non-GAAP) rates are defined in the previous section titled "Reportable Segment Revenues and Profits". Nine Months Ended September 30, 2022 Nine Months Ended September 30, 2021 Change in Revenue Revenue Organic Revenue (Non-GAAP) as Changes in Organic Revenue as Divestitures Organic Revenue (in millions) Reported Exchange Rates (Non-GAAP) Reported and Discontinuations (Non-GAAP) Amount Pct. Vision Care$ 1,747 $ 82$ 1,829 $ 1,717 $ -$ 1,717 $ 112 7 %Ophthalmic Pharmaceuticals 495 18 513 527 - 527 (14) (3) % Surgical 530 30 560 520 (7) 513 47 9 % Total$ 2,772 $ 130 $ 2,902 $ 2,764 $ (7)$ 2,757 $ 145 5 % Vision Care Segment:
Vision Care Segment Revenue
The Vision Care segment revenue was$1,747 million and$1,717 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$30 million , or 2%. The increase was driven by: (i) an increase in net pricing of$58 million , primarily due to pricing increases across certain contact lens and consumer products and (ii) an increase in volumes of$54 million . The increase in volumes was primarily due to: (i) increased demand for Lumify®, Biotrue® and PreserVision® within our consumer eye care business, (ii) the non-recurrence of a third-party supplier quality issue on the prior year revenues of certain consumer eye care products, as previously discussed, and (iii) new launches within our international contact lens business. These increases were partially offset by: (i) the unfavorable impact of foreign currencies of$82 million , primarily inEurope andAsia and (ii) the impact of the COVID-19 pandemic during the first half of the year on our contact lens business inChina .
Vision Care Segment Profit
The Vision Care segment profit was$471 million and$431 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$40 million , or 9%. The increase was primarily driven by: (i) the increase in net realized pricing and volumes as previously discussed, (ii) lower R&D expense, primarily in ourU.S. contact lens, (iii) lower advertising and promotional expenses, primarily in ourU.S. contact lens and International consumer businesses and (iv) lower G&A expenses in theU.S. consumer eye care and contact lens businesses. These increases were partially offset by: (i) 53 -------------------------------------------------------------------------------- higher manufacturing variances, driven by inflationary pressures and higher manufacturing efficiency ramp-up costs of our Daily SiHy lenses and (ii) higher selling expenses primarily due to increased freight costs. The higher manufacturing costs were partially offset by the non-recurrence of prior year charges related to a quality issue at a third-party supplier, as discussed above.
Ophthalmic Pharmaceuticals Segment:
Ophthalmic Pharmaceuticals Segment Revenue
The Ophthalmic Pharmaceuticals segment revenue was$495 million and$527 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$32 million , or 6%. The decrease was driven by: (i) a decrease in net realized pricing of$31 million due to higher chargeback rates for certain generics products as a result of product and customer mix and lower contract pricing due to increased competition on certain products and (ii) the unfavorable impact of foreign currencies of$18 million , partially offset by an increase in volumes of$17 million , primarily inEurope .
Ophthalmic Pharmaceuticals Segment Profit
The Ophthalmic Pharmaceuticals segment profit was$142 million and$208 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$66 million , or 32%. The decrease was primarily driven by: (i) the decrease in net realized pricing, as previously discussed, (ii) higher selling, advertising and promotional expenses, primarily as a result of newly launched products, such as XIPERE® in the first quarter of 2022 and (iii) higher R&D expense. Surgical Segment: Surgical Segment Revenue The Surgical segment revenue was$530 million and$520 million for the nine months endedSeptember 30, 2022 and 2021, respectively, an increase of$10 million , or 2%. The increase was driven by: (i) an increase in volumes of$42 million , primarily due to increased demand of consumables and intraocular lenses and (ii) an increase in net realized pricing of$5 million . These increases were partially offset by: (i) the unfavorable effect of foreign currencies of$30 million , primarily inEurope and (ii) the impact of divestitures and discontinuations of$7 million , related to the discontinuation of certain products.
Surgical Segment Profit
The Surgical segment profit was$35 million and$55 million for the nine months endedSeptember 30, 2022 and 2021, respectively, a decrease of$20 million , or 36%. The decrease was primarily driven by: (i) higher selling, advertising and promotional expenses and (ii) higher R&D expenses. These decreases were partially offset by the increase in volumes, as previously discussed.
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