ANIKA THERAPEUTICS, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) | MarketScreener

2022-08-08 09:54:57 By : Ms. Reann Cheung

As we look towards the future, our business is positioned to capture value within our target market of joint preservation. We believe our success will be driven by our:

? Energized and experienced team focused on strong values, talent, and culture.

Our OA Pain Management product family consists of:

? Monovisc and Orthovisc, our single- and multi-injection, HA-based

viscosupplement product offerings indicated to provide pain relief from OA

conditions solely for use in the knee. Our OA Pain Management products are

generally administered to patients in an office setting. In the United States,

Monovisc and Orthovisc are marketed exclusively by DePuy Synthes Mitek Sports

Medicine, part of the Johnson & Johnson Medical Companies. The Monovisc and

Orthovisc products have been the market leaders, based on combined overall

revenue in the viscosupplement market, since 2018. Internationally, we market

? Cingal, our novel, third-generation, single-injection OA Pain Management

product consisting of our proprietary cross-linked HA material combined with a

fast-acting steroid. Cingal is designed to provide both short- and long-term

pain relief. Cingal is CE Mark approved and for several years has been sold

outside the United States directly in over 30 countries through our network of

distributors. In the United States, Cingal is a pipeline product currently

? Hyvisc, our high molecular weight injectable HA veterinary product approved

Our Joint Preservation and Restoration product family consists of:

? Bone Preserving Joint Technologies. Our portfolio of more than 150 bone

preserving joint technologies, including partial joint replacement, joint

resurfacing, and minimally invasive and bone sparing implants, is designed to

treat upper and lower extremity orthopedic conditions as well as knee and hip

conditions caused by arthritic disease, acute trauma and injury. These

products span multiple joints including the shoulder, foot/ankle, wrist, knee

and hip and are generally intended to restore a patient's natural anatomy and

movement. These products are often used to treat patients with OA progression

beyond where our OA Pain Management products can allow the patients to retain

an active lifestyle when early surgical intervention becomes preferable.

surgeons to repair and reconstruct damaged ligaments and tendons resulting

from sports injuries, acute trauma and disease. These more traditional sports

medicine solutions include screws, sutures, suture anchors, grafts and other

surgical systems that facilitate surgical procedures on the shoulder, knee,

? Regenerative Solutions. Our portfolio of orthopedic regenerative solutions

leveraging our proprietary technologies based on HA and Hyaff, which is a

solid form of HA. These products include Tactoset Injectable Bone Substitute,

an HA-enhanced injectable bone repair therapy designed to treat insufficiency

fractures and for augmenting hardware fixation, such as suture anchors and

Hyalofast, a biodegradable support for human bone marrow mesenchymal stem

cells used for cartilage regeneration and as an adjunct for microfracture

surgery. Tactoset cleared and commercialized principally in the United States,

whereas Hyalofast is CE Mark approved and currently available outside the

United States in over 30 countries within Europe, South America, Asia, and

certain other international markets. In the United States, Hyalofast is a

product under clinical trial studies and is not available for commercial sale.

The following tables present product revenue by product family:

Contingent Consideration Fair Value Change

Adjusted Gross Profit and Adjusted Gross Margin

The following is a reconciliation of adjusted gross profit to gross profit for the three- and six-month periods ended June 30, 2022 and 2021, respectively:

The following is a reconciliation of net income (loss) to adjusted EBITDA for the three- and six-month periods ended June 30, 2022 and 2021, respectively:

Adjusted Net Income (Loss) and Adjusted EPS

The following is a reconciliation of adjusted net income (loss) to net income (loss) for the three- and six-month periods ended June 30, 2022 and 2021, respectively:

The following is a reconciliation of adjusted EPS to diluted earnings (loss) per share for the three- and six-month periods ended June 30, 2022 and 2021:

Diluted (loss) earnings per share (EPS) $ (0.20 ) $ 0.45

(59 ) Net (decrease) in cash and cash equivalents $ (2,994 ) $ 1,364

Critical Accounting Policies and Estimates

A discussion of Recent Accounting Pronouncements is included in our 2021 Form 10-K for the fiscal year ended December 31, 2021.

Contractual Obligations and Other Commercial Commitments

© Edgar Online, source Glimpses