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Anika Therapeutics (ANIK) posted 3Q17 orthobiologic revenue of US $24.0MM, +7.0% vs. 3Q16, and year-to-date revenue of $68.7MM, +5.2% vs. the prior year.
| 3Q17 | 3Q16 | $ Change | % Change | |
| Orthobiologics | $24.0 | $22.4 | $1.6 | 7.0% |
| 9Mo17 | 9Mo16 | $ Change | % Change | |
| Orthobiologics | $68.7 | $65.3 | $3.4 | 5.2% |
ANIK’s quarterly orthobiologic revenue has increased sequentially throughout 2017, growing from low-single-digits to mid-single digits year over year. Clinical activity remains high for the company, which markets a variety of viscosupplement therapies and has numerous regenerative therapies in its pipeline.
MONOVISC remained a market share-grabber and primary revenue driver, as physicians continued to choose single-injection solutions to treat osteoarthritis (OA) pain. Global MONOVISC revenue grew 50% year over year, partially offset by the continued decline in multi-injection ORTHOVISC sales.
Geographically, 3Q17 orthobiologics grew 10% vs. 3Q16 on strong CINGAL and MONOVISC sales, and ORTHOVISC and MONOVISC maintained their domestic market leadership.
CINGAL has been launched for distribution in Italy by Abiogen Pharma. Globally, 45,000 units of CINGAL have been sold since 2016, with U.S. end-user sales of up to $40MM.
Clinical and regulatory highlights, summarized:
- MONOVISC secured regulatory approval in Australia, India and Taiwan for use in all synovial joints. Sales commenced in 4Q.
- An FDA 510(k) application was submitted for an injectable, self-setting, resorbable hyaluronic acid-based bone repair treatment.
- Results from a four-year study indicated that HYALOFAST biodegradable HA-based scaffold + autologous adult mesenchymal stem cells (MSCs) is a viable, effective option to treat knee cartilage lesions, regardless of patient age. Outside of the U.S., HYALOFAST has treated >11,000 patients in 15 countries.
- All sites are up and running for the MONOVISC hip trial, but still below 50% trial enrollment. Mitek seeks to enroll 560 patients.
- After the quarter’s close, in October, ANIK completed enrollment of 576 patients—ahead of its year-end schedule—for its second pivotal Phase III trial evaluating CINGAL hyaluronic acid/corticosteroid viscosupplement for the treatment of knee OA symptoms. The early completion was attributed largely to physician and patient interest. This trial is slated to complete in 2018; CINGAL could receive FDA clearance in 1H19.
Source: Anika Therapeutics, Inc.
Anika Therapeutics (ANIK) posted 3Q17 orthobiologic revenue of US $24.0MM, +7.0% vs. 3Q16, and year-to-date revenue of $68.7MM, +5.2% vs. the prior year.
Q17
3Q16
$ Change
% Change
Orthobiologics
$24.0 ...
Anika Therapeutics (ANIK) posted 3Q17 orthobiologic revenue of US $24.0MM, +7.0% vs. 3Q16, and year-to-date revenue of $68.7MM, +5.2% vs. the prior year.
| 3Q17 | 3Q16 | $ Change | % Change | |
| Orthobiologics | $24.0 | $22.4 | $1.6 | 7.0% |
| 9Mo17 | 9Mo16 | $ Change | % Change | |
| Orthobiologics | $68.7 | $65.3 | $3.4 | 5.2% |
ANIK’s quarterly orthobiologic revenue has increased sequentially throughout 2017, growing from low-single-digits to mid-single digits year over year. Clinical activity remains high for the company, which markets a variety of viscosupplement therapies and has numerous regenerative therapies in its pipeline.
MONOVISC remained a market share-grabber and primary revenue driver, as physicians continued to choose single-injection solutions to treat osteoarthritis (OA) pain. Global MONOVISC revenue grew 50% year over year, partially offset by the continued decline in multi-injection ORTHOVISC sales.
Geographically, 3Q17 orthobiologics grew 10% vs. 3Q16 on strong CINGAL and MONOVISC sales, and ORTHOVISC and MONOVISC maintained their domestic market leadership.
CINGAL has been launched for distribution in Italy by Abiogen Pharma. Globally, 45,000 units of CINGAL have been sold since 2016, with U.S. end-user sales of up to $40MM.
Clinical and regulatory highlights, summarized:
- MONOVISC secured regulatory approval in Australia, India and Taiwan for use in all synovial joints. Sales commenced in 4Q.
- An FDA 510(k) application was submitted for an injectable, self-setting, resorbable hyaluronic acid-based bone repair treatment.
- Results from a four-year study indicated that HYALOFAST biodegradable HA-based scaffold + autologous adult mesenchymal stem cells (MSCs) is a viable, effective option to treat knee cartilage lesions, regardless of patient age. Outside of the U.S., HYALOFAST has treated >11,000 patients in 15 countries.
- All sites are up and running for the MONOVISC hip trial, but still below 50% trial enrollment. Mitek seeks to enroll 560 patients.
- After the quarter’s close, in October, ANIK completed enrollment of 576 patients—ahead of its year-end schedule—for its second pivotal Phase III trial evaluating CINGAL hyaluronic acid/corticosteroid viscosupplement for the treatment of knee OA symptoms. The early completion was attributed largely to physician and patient interest. This trial is slated to complete in 2018; CINGAL could receive FDA clearance in 1H19.
Source: Anika Therapeutics, Inc.
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
