Anika Therapeutics (NASDAQ:ANIK) develops and markets bio-polymer (based on naturally occurring polymer hyaluronic acid or HA) joint health and tissue repair products.
After the market close Wednesday, $ANIK reported its 1Q11 results, which suffered from a one-time shipment delay (due to equipment problem at Woburn facility) of $1.4 million [M] that was shipped in April (i.e. likely to boost 2Q11 results) as manufacturing operations resumed.
- 1Q11 orthobiologic sales rose 16%, driven by continued strong US sales of ORTHOVISC and acquired Anika S.r.l. product sales increased 22% from year-ago period
- Product revenue declined 5% to $11.1M vs. $11.6M in the year-ago period and 1Q11 total revenue declined 5.8% to $11.7M vs. $12.5M in the year-ago period
- Adjusting for the $1.4M product shipment delay, 1Q11 product revenue would have been $12.5M (a 7.2% increase from the year-ago period)
- operating expenses declined during 1Q11, including R&D (research and development) expenses of $1.5M (vs. $1.9M in year-ago period) and SG&A (selling, general, and admin) expenses of $4M vs. $4.3M in year-ago period
- 1Q11 net income was $324,000 or $0.02 per diluted share vs. $714,000 or $0.05 per diluted share in year-ago period
- As of 3/31/11, had $29.1 million [M] cash / equivalents (up from $28.2M at year-end 2010 due to positive cash flow generated from operations) w/ $10.8M long-term debt and 13.5M shares of common stock outstanding
Below is a summary of four pending FDA medical device submissions for $ANIK, which provided guidance on the 1Q11 conference call for a FDA reply within 60 days for MONOVISC following a recent meeting w/ the Agency that was conducted instead of the advisory panel meeting that $ANIK previously requested to resolve questions surrounding the PMA. $ANIK is also optimistic regarding approval of three pending 510(k) submissions for bio-polymer joint health products acquired w/ FAB that are currently marketed in Europe.
Product Candidate #1) MONOVISC (single-injection, bio-polymer arthritis product)
On 5/5/11, provided update following recent FDA meeting (conducted last week instead of advisory panel meeting that ANIK requested to resolve issues) and expects reply in 60 days (7/5/11 estimate) for PMA submitted in DEC 2009.
No safety issues were discussed and FDA is reviewing the efficacy results after a second submission by $ANIK in late 2010 to address questions by the Agency over efficacy analyses performed in support of the PMA filing.
MONOVISC is designed as a follow-on product to ORTHOVISC as a single injection and six-month treatment duration for arthritis symptoms and has been marketed in Europe since 2Q08
Genzyme amended its lawsuit last week to add a third patent that expires after 2020, $ANIK working to defend MONOVISC based on the revised claim by Genzyme
Product Candidates #1-4) FDA Decision 510(k) Medical Devices -- Hyalofast, Hyaloglide, and Hyalonect (Bio-Polymer Joint Health Products)
Estimated FDA decisions by mid-2011 (2-3Q11) for three joint health products marketed in Europe from FAB acquisition, including Hyalofast (adult, patient-derived bone marrow stem cell enriched tissue repair pad, Hyaloglide (healing aid gel w/ five-day duration for tendon / nerve surgeries) and Hyalonect (bone wrap mesh that is incorporated into the bone)
I added to my long position in $ANIK on the sell-off due to weak quarterly results due to a one-time shipment delay that was sent in April (will be reflected in 2Q11 results), and I believe shares may rebound to the $10+ level now that the FDA has provided a 60-day window for an expected reply on the Company’s most important product candidate pending at FDA, MONOVISC, which is designed as a follow-on product to its top-selling joint health product ORTHOVISC.
In addition, 1Q11 results suffered from a one-time shipment delay to equipment problems that have since been resolved, so 2Q11 results are likely to benefit from the shortfall this quarter, and $ANIK continues to enjoy a strong balance sheet with an increased cash position from year-end despite the weak quarterly results.