ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (amounts in thousands, except per share amounts or as otherwise noted)
|
You should read the following discussion in conjunction with our
financial statements and related notes appearing elsewhere in this report. In addition to historical information, this discussion
contains forward-looking statements that involve risks, uncertainties, and assumptions that could cause our actual results to differ
materially from our expectations. Words such as “will,” “likely,” “may,” “believe,”
“expect,” “anticipate,” “intend,” “seek,” “designed,” “develop,”
“would,” “future,” “can,” “could,” and other expressions that are predictions of
or indicate future events and trends, and which do not relate to historical matters, are intended to identify such forward-looking
statements. These statements are likely to relate to, among other things, our goals, plans and projections regarding our financial
position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses,
performance, and results related to current or anticipated products. You should carefully consider forward-looking statements and
understand that such statements may be affected by inaccurate assumptions and may involve a variety of risks and uncertainties,
known and unknown, including, among others, risks related to competition in the medical device industry, reduction or interruption
in our supply, quality problems, decreasing prices, changes in applicable tax rates, adverse regulatory action, health care policy
changes, international operations, or disruption of our current plans and operations, as well as those factors described in Part
II, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2015, and as may be updated
in our subsequent Quarterly Reports on Form 10-Q. Consequently, no forward-looking statements can be guaranteed and actual results
may vary materially, and you should take caution not to place undue reliance on such statements. We undertake no obligation to
release publicly any revisions to forward-looking statements as a result of new information, future events, or otherwise.
Management Overview
We are a global, integrated orthopedic medicines company committed
to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies
along the continuum of care, from palliative pain management to regenerative cartilage repair. We have over two decades of global
expertise developing, manufacturing, and commercializing our products based on our proprietary HA technology. Our orthopedic medicine
portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA,
and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration.
Our therapeutic offerings consist of products in the following areas:
Orthobiologics, Dermal, Surgical, Ophthalmic, and Veterinary. All of our products are based on HA, a naturally occurring, biocompatible
polymer found throughout the body. Due to its unique biophysical and biochemical properties, HA plays an important role in a number
of physiological functions such as the protection and lubrication of soft tissues and joints, the maintenance of the structural
integrity of tissues, and the transport of molecules to and within cells.
Our proprietary technologies for modifying the HA molecule allow
product properties to be tailored specifically to therapeutic use. Our patented technology chemically modifies HA to allow for
longer residence time in the body. We also offer products made from HA based on two other technologies: HYAFF, which is a solid
form of HA, and ACP gel, an autocross-linked polymer of HA. Our technologies are protected by an extensive portfolio of owned
and licensed patents.
Since our inception in 1992, we have utilized a commercial partnership
model for the distribution of our products to end-users. Our strong, worldwide network of distributors has historically provided,
and continues to provide, a solid foundation for our revenue growth and territorial expansion. In 2015, we made the strategic decision
to commercialize our next generation viscosupplementation product, CINGAL, in the United States ourselves, initially through the
engagement of a contract sales organization. Ultimately, we intend to transition the direct sales function into our company as
part of a broader buildout of our commercial capabilities. We believe that the combination of the direct and distribution commercial
models will maximize the revenue potential from our current and future product portfolio.
We began a strategic project in 2015 to
move the manufacturing of our HYAFF-based products, which are under an existing contract manufacturing agreement with a third party
in Italy, to our Bedford, Massachusetts facility. Our main purposes behind this strategic move are to improve the efficiency of
our manufacturing process and to enhance our research and development capabilities, with the aim of accelerating future product
development. We expect to expend approximately $25 million on this project.
Please see the section captioned “Item 7. Management’s
Discussion and Analysis of Financial Condition and Results of Operations-Management Overview” in our Annual Report on Form
10-K for the year ended December 31, 2015, for a description of each of the above therapeutic areas, including the individual products.
Research and Development
Our research and development efforts primarily
consist of the development of new medical applications for our HA-based technology, the management of clinical trials for certain
product candidates, the preparation and processing of applications for regulatory approvals or clearances at all relevant stages
of product development, and process development and scale-up manufacturing activities for our existing and new products. Our development
focus includes products for tissue protection, repair, and regeneration. We anticipate that we will continue to commit significant
resources to research and development, including clinical trials in the future.
Our second single-injection osteoarthritis
product under development in the United States is CINGAL, which is composed of our proprietary cross-linked HA material combined
with an approved steroid and is designed to provide both short- and long-term pain relief to patients. We completed a CINGAL phase
III clinical trial and associated statistical analysis during the fourth quarter of 2014. During the first half of 2015, we completed
a CINGAL retreatment study with patients who had participated in the phase III clinical trial and reported safety data related
to the retreatment study. We received approval for CINGAL from Health Canada in November 2015 for the treatment of pain in osteoarthritis
of the knee. In March 2016, we received CE Mark approval of CINGAL as a viscoelastic supplement or as a replacement for synovial
fluid in human joints. We successfully achieved commercial launch of the product in Canada during May 2016 and in the European
Union during June 2016. In the United States, after discussions with the FDA related to the regulatory pathway for CINGAL, we conducted
a formal meeting with the FDA’s Office of Combination Products (“OCP”) to present and discuss our data in September
2015, and we submitted a formal request for designation with OCP a month later. In its response to our formal request for designation,
OCP assigned the product to the FDA’s Center for Drug Evaluation and Research (“CDER”) as the lead agency center
for premarket review and regulation. Since then, we have been in ongoing discussions with CDER to understand the requirements for
submitting a New Drug Application (“NDA”) for CINGAL. We held a meeting with CDER at the end of September 2016 to align
on an approval framework and on submission requirements for this NDA for CINGAL, including the execution of an additional Phase
III clinical trial to supplement our strong, existing CINGAL pivotal study data. Once the final details are confirmed by CDER,
we intend to submit an Investigational New Drug Application (“IND”) and to commence this phase III
clinical trial by early 2017.
We have several research and development
programs underway for new products, including for HYALOFAST (in the United States), an innovative product for cartilage tissue
repair, HYALOBONE, a bone void filler, and other early stage regenerative medicine development programs. HYALOFAST received CE
Mark approval in September 2009, and it is commercially available in Europe and certain international countries. During the first
quarter of 2015, we submitted an Investigational Device Exemption (“IDE”) for HYALOFAST to the FDA, which was approved
in July 2015. We commenced patient enrollment in a clinical trial in December 2015, and we are advancing site initiations and patient
enrollment activities. In the second quarter of 2016, a supplement to the HYALOFAST IDE was approved to expand the inclusion criteria
for the clinical study. The purpose of this supplement is to allow us to increase enrollment rates with the ultimate goal of decreasing
the time needed to complete the clinical trial. We are also currently proceeding with other research and development programs,
one of which utilizes our proprietary HA technology to treat pain associated with common repetitive overuse injuries, such as those
to the elbow, rotator cuff, and Achilles tendon. We submitted a CE Mark application for this treatment during the first quarter
of 2016, and we expect approval of this application during the first half of 2017. Additionally, in the second quarter of 2016,
we submitted an IDE to the FDA to conduct a phase III pivotal clinical trial for this treatment, which was approved by the FDA
in June 2016.
In June 2015, we entered into an agreement with the Institute for
Applied Life Sciences at the University of Massachusetts Amherst to collaborate on research to develop a therapy for rheumatoid
arthritis. The purpose of this research is to develop a novel modality for the treatment of rheumatoid arthritis and, if successful,
it is expected to yield a potential product candidate that we could begin to move towards commercialization as early as 2017.
Results of Operations
Three and Nine Months Ended
September 30, 2016 Compared to Three and Nine Months Ended September 30, 2015
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2015
|
|
$ Inc/(Dec)
|
|
% Inc/(Dec)
|
|
2016
|
|
2015
|
|
$ Inc/(Dec)
|
|
% Inc/(Dec)
|
|
|
(in thousands, except percentages)
|
|
(in thousands, except percentages)
|
Product revenue
|
|
$
|
25,783
|
|
|
$
|
23,676
|
|
|
$
|
2,107
|
|
|
|
9
|
%
|
|
$
|
74,636
|
|
|
$
|
62,089
|
|
|
$
|
12,547
|
|
|
|
20
|
%
|
Licensing, milestone and contract revenue
|
|
|
6
|
|
|
|
5
|
|
|
|
1
|
|
|
|
20
|
%
|
|
|
17
|
|
|
|
16
|
|
|
|
1
|
|
|
|
6
|
%
|
Total revenue
|
|
|
25,789
|
|
|
|
23,681
|
|
|
|
2,108
|
|
|
|
9
|
%
|
|
|
74,653
|
|
|
|
62,105
|
|
|
|
12,548
|
|
|
|
20
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
4,998
|
|
|
|
5,176
|
|
|
|
(178
|
)
|
|
|
(3
|
%)
|
|
|
16,488
|
|
|
|
14,764
|
|
|
|
1,724
|
|
|
|
12
|
%
|
Research & development
|
|
|
2,822
|
|
|
|
2,061
|
|
|
|
761
|
|
|
|
37
|
%
|
|
|
7,773
|
|
|
|
5,971
|
|
|
|
1,802
|
|
|
|
30
|
%
|
Selling, general & administrative
|
|
|
4,280
|
|
|
|
3,309
|
|
|
|
971
|
|
|
|
29
|
%
|
|
|
12,525
|
|
|
|
10,302
|
|
|
|
2,223
|
|
|
|
22
|
%
|
Total operating expenses
|
|
|
12,100
|
|
|
|
10,546
|
|
|
|
1,554
|
|
|
|
15
|
%
|
|
|
36,786
|
|
|
|
31,037
|
|
|
|
5,749
|
|
|
|
19
|
%
|
Income from operations
|
|
|
13,689
|
|
|
|
13,135
|
|
|
|
554
|
|
|
|
4
|
%
|
|
|
37,867
|
|
|
|
31,068
|
|
|
|
6,799
|
|
|
|
22
|
%
|
Interest income, net
|
|
|
93
|
|
|
|
34
|
|
|
|
59
|
|
|
|
174
|
%
|
|
|
214
|
|
|
|
82
|
|
|
|
132
|
|
|
|
161
|
%
|
Income before income taxes
|
|
|
13,782
|
|
|
|
13,169
|
|
|
|
613
|
|
|
|
5
|
%
|
|
|
38,081
|
|
|
|
31,150
|
|
|
|
6,931
|
|
|
|
22
|
%
|
Provision for income taxes
|
|
|
4,830
|
|
|
|
4,789
|
|
|
|
41
|
|
|
|
1
|
%
|
|
|
13,619
|
|
|
|
11,435
|
|
|
|
2,184
|
|
|
|
19
|
%
|
Net income
|
|
$
|
8,952
|
|
|
$
|
8,380
|
|
|
$
|
572
|
|
|
|
7
|
%
|
|
$
|
24,462
|
|
|
$
|
19,715
|
|
|
$
|
4,747
|
|
|
|
24
|
%
|
Product gross profit
|
|
$
|
20,785
|
|
|
$
|
18,500
|
|
|
$
|
2,285
|
|
|
|
12
|
%
|
|
$
|
58,148
|
|
|
$
|
47,325
|
|
|
$
|
10,823
|
|
|
|
23
|
%
|
Product gross margin
|
|
|
81
|
%
|
|
|
78
|
%
|
|
|
|
|
|
|
|
|
|
|
78
|
%
|
|
|
76
|
%
|
|
|
|
|
|
|
|
|
Product Revenue
Product revenue for the quarter ended September 30, 2016 was $25.8
million, an increase of 9% as compared to $23.7 million for the quarter ended September 30, 2015.
Product
revenue for the nine-month period ended September 30, 2016 was $74.6 million, an increase of 20% as compared to $62.1 million for
the nine-month period ended September 30, 2015.
For the three- and nine-month periods ended September 30, 2016, the increase
in product revenue was mainly driven by the growth of our orthobiologics franchise with such increase being partially offset by
a decrease in revenue from our surgical franchise. Included in product revenue for the first and second quarters of 2015 was approximately
$1.8 million of non-recurring true-up revenue related to a high end-user average selling price for MONOVISC products sold to our
U.S. partner, DePuy Synthes Mitek Sports Medicine (“Mitek”), prior to the fourth quarter of 2014. The amount was agreed
with Mitek during the second quarter of 2015, and MONOVISC product sold to Mitek after the third quarter of 2014 is not impacted
by this arrangement.
The following tables present product revenue by product group for
the three- and nine-month periods ended September 30, 2016 and 2015:
|
|
Three Months Ended September 30,
|
|
|
2016
|
|
2015
|
|
$ Inc/(Dec)
|
|
%
Inc/(Dec)
|
|
|
(in thousands, except percentages)
|
Orthobiologics
|
|
$
|
22,428
|
|
|
$
|
20,461
|
|
|
$
|
1,967
|
|
|
|
10
|
%
|
Surgical
|
|
|
1,173
|
|
|
|
1,413
|
|
|
|
(240
|
)
|
|
|
(17
|
%)
|
Dermal
|
|
|
594
|
|
|
|
412
|
|
|
|
182
|
|
|
|
44
|
%
|
Other
|
|
|
1,588
|
|
|
|
1,390
|
|
|
|
198
|
|
|
|
14
|
%
|
Total
|
|
$
|
25,783
|
|
|
$
|
23,676
|
|
|
$
|
2,107
|
|
|
|
9
|
%
|
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2015
|
|
$ Inc/(Dec)
|
|
%
Inc/(Dec)
|
|
|
(in thousands, except percentages)
|
Orthobiologics
|
|
$
|
65,319
|
|
|
$
|
51,717
|
|
|
$
|
13,602
|
|
|
|
26
|
%
|
Surgical
|
|
|
3,924
|
|
|
|
4,450
|
|
|
|
(526
|
)
|
|
|
(12
|
%)
|
Dermal
|
|
|
1,558
|
|
|
|
1,132
|
|
|
|
426
|
|
|
|
38
|
%
|
Other
|
|
|
3,835
|
|
|
|
4,790
|
|
|
|
(955
|
)
|
|
|
(20
|
%)
|
Total
|
|
$
|
74,636
|
|
|
$
|
62,089
|
|
|
$
|
12,547
|
|
|
|
20
|
%
|
Orthobiologics
Our orthobiologics franchise consists of
our joint health and orthopedic products. Overall, sales increased 10% and 26% for the three- and nine-month periods ended September
30, 2016, respectively, as compared to the same periods in 2015. The growth in the three- and nine-month periods ending September
30, 2016 was primarily due to an increase in MONOVISC revenue in the United States
. Both
Orthovisc and Monovisc unit volumes increased during the three- and nine- months ended September 30, 2016. This volume gain was
partially offset by the impact of pricing concessions made by our U.S. commercial partner Mitek, which were aimed at growing U.S.
market share. Internationally, we experienced a 27% increase in orthobiologics revenue for the nine-month period ended September
30, 2016, as compared to the same period in 2015
. We expect orthobiologics revenue to continue to grow for the remainder
of 2016, led by increased MONOVISC revenue in the U.S. and international markets, the commercial availability of CINGAL in Canada
and Europe, as well as overall revenue growth from our viscosupplementation products both domestically and internationally.
Surgical
Our surgical franchise consists of products
used to prevent surgical adhesions and to treat ear, nose, and throat (“ENT”) disorders. Sales of our surgical products
decreased 17% and 12% for the three- and nine-month periods ended September 30, 2016 to $1.2 million and $3.9 million, respectively,
as compared to the same periods in 2015. The decrease in surgical product revenue for the three- and nine-month periods was primarily
due to
a decrease in sale to our worldwide ENT commercial partner
. We expect surgical
product revenue to decrease moderately for the full-year 2016, as compared to 2015.
Dermal
Our dermal franchise
consists
of advanced wound care products, which are based on our HYAFF technology, and aesthetic dermal fillers
. Our advanced wound
care products treat complex skin wounds ranging from burns to diabetic ulcers, with HYALOMATRIX and HYALOFILL as the lead products.
For the three- and nine-month periods ended September 30, 2016, dermal product sales increased 44% and 38%, respectively, as compared
to the same periods in 2015.
This increase reflects rising domestic and international end-user
demand, as well as order timing by our distribution partners. We expect advanced wound care revenue to increase for the full-year
2016, as compared to 2015, primarily due to increased end-user demand, increased U.S. reimbursement coverage, and geographic expansion,
particularly in the U.S., European, and Latin American markets.
Other
Other product revenue includes revenues from our ophthalmic and veterinary
franchises. Product revenue from each of these franchises increased for the three-month period ended September 30, 2016 while decreasing
for the nine-month period then ended, as compared to the same periods in 2015. We expect other product revenue to decrease for
the full-year 2016, as compared to 2015,
primarily as a result of lower veterinary revenue
.
Product gross profit and margin
Product
gross profit for the three- and nine-month periods ended September 30, 2016 increased $2.3 million and $10.8 million to $20.8 and
$58.1 million, respectively, representing 81% and 78% of product revenue, respectively. Product gross profit for the three- and
nine- months ended September 30, 2015 was $18.5 million and $47.3 million
, or 78% and 76% of
product
revenue for each period, respectively. The increase in product gross margin for the three-month period ended September 30, 2016,
as compared to the same period in 2015, was primarily attributable to
the increase in production volume as compared to the
prior year. This
quarter’s product gross margin may not be indicative of the rest of
the year due to dynamics such as future revenue mix and production volume variability.
Research and development
Research and development expenses for the
three- and nine-month periods ended September 30, 2016 were $2.8 million and $7.8 million, or 11% and 10% of total revenue for
the respective periods, an increase of $0.8 million and $1.8 million, respectively, as compared to the same periods in 2015.
The
increase in research and development expenses was primarily due to the timing and the higher level of clinical activities associated
with the HYALOFAST phase III study, which commenced in December 2015. Furthermore, we also increased our pre-clinical product development
activities, including with respect to the CE Mark application and IDE for our program which seeks to utilize our proprietary HA
technology to treat pain associated with common repetitive overuse injuries, such as those to the elbow, rotator cuff, and Achilles
tendon.
Research and development spending is expected to increase in 2016, and for the foreseeable future, as compared to
2015, as we further develop new products and initiate new clinical trials based on our existing technology assets, including HYALOFAST,
CINGAL, as well as increase development activities for other products in our pipeline.
Selling, general, and administrative
Selling, general, and administrative (“SG&A”) expenses for the three- and nine-month periods ended
September 30, 2016 were $4.3 million and $12.5 million, representing 17% of total revenue for both periods, an increase of $1.0
million and $2.2 million, respectively, as compared to the same periods in 2015. SG&A expenses increased for the three- and
nine-month periods ending September 30, 2016 primarily
as a result of increases in personnel
related costs, marketing initiatives to support CINGAL international launches, and external professional fees.
We expect
selling, general, and administrative expenses for 2016 will increase in comparison to 2015 to reflect the support required to grow
our business, both domestically and internationally.
Income taxes
Provisions for income taxes were $4.8 million
and $13.6 million for the three- and nine-month periods ended September 30, 2016, based on effective tax rates of 35.0% and 35.8%,
respectively. Provisions for income taxes were $4.8 million and $11.4 million for the three- and nine-month periods ended September
30, 2015, based on effective tax rates of 36.4% and 36.7%, respectively. The increase in income taxes for the three- and nine-month
period ended September 30, 2016 resulted from higher income before income taxes as compared to the same periods in the prior
year. The net decrease in the effective tax rate
for the three- and nine-month period ended
September 30, 2016, as compared to the same period in 2015,
was primarily due to an increase in the expected tax credit
for research and development expenditures.
Liquidity and Capital Resources
We expect that our requirements for cash to fund operations and capital
expenditures will increase as the scope of our operations expands. Historically, we have generated positive cash flow from operations,
which together with our available cash and investments have met our cash requirements. Cash, cash equivalents, and investments
totaled approximately $120.3 million and $138.5 million at September 30, 2016 and December 31, 2015, respectively. Working capital
totaled approximately $153.5 million at September 30, 2016 and $159.2 million at December 31, 2015. We believe that we have
adequate financial resources to support our business for at least the next twelve months.
Cash provided by operating activities was
$17.9 million for the nine months ended September 30, 2016, as compared to cash provided by operating activities of
$23.8
million
for the same period in 2015. The decrease in cash provided by operations for the nine months ended September
30, 2016,
as compared to the same period in 2015, was primarily related to planned inventory
build resulting from the transfer of outsourced contract manufacturing from Italy to our Bedford, Massachusetts facility, and a
decrease in income taxes payable and accounts payable due to the timing of payments.
Cash used in investing activities was $7.1 million for the nine months
ended September 30, 2016, as compared to cash used in investing activities of
$17.3 million
for the same period in 2015. The decrease in cash used in investing activities was primarily the result of the purchase
of investments offset by maturities of investments during the first three quarters of 2016, as well as increased expenditures on
capital equipment. We expect an increase in investing activities for the full year 2016 in comparison to 2015 as a result of our
on-going project to establish the additional manufacturing capabilities at the Bedford, Massachusetts facility required to manufacture
our HYAFF-based products, which were previously manufactured by a third party in Italy. During the quarter ended September 30,
2016, we expended approximately $0.9 million for this project. We expect to expend approximately an additional $4.2 million on
this project over the course of the next nine months.
Cash used in financing activities was $23.6
million for the nine months ended September 30, 2016, as compared to cash provided by financing activities totaling
$2.0
million
for the same period in 2015. The increase in cash used in financing activities for the nine months ended September
30, 2016 was primarily attributable to the
ASR Agreement to purchase $25.0
million of shares of our common stock. Pursuant to the terms of the ASR Agreement, we paid Morgan Stanley $25.0 million in
cash and received a total delivery of 531,067 shares of our common stock at an average repurchase price of $47.08 during the nine-month
period ended September 30, 2016.
Critical Accounting Estimates
There were no other significant
changes in our critical accounting estimates during the three months ended September 30, 2016, as compared to the critical accounting
estimates disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in
our Annual Report on Form 10-K for the fiscal year ended December 31, 2015.
Recent Accounting Pronouncements
A discussion of Recent Accounting
Pronouncements is included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and updated in Note 3
to the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.
Contractual Obligations and Other Commercial Commitments
Our contractual obligations and other commercial commitments are
summarized in the section captioned “Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2015. We had no material changes
outside the ordinary course to our contractual obligations, as reported in our 2015 Annual Report on Form 10-K, during the first
nine months of 2016.
To the extent that funds generated from our operations, together
with our existing capital resources, are insufficient to meet future requirements, we will be required to obtain additional funds
through equity or debt financings, strategic alliances with corporate partners and others, or through other sources. No assurance
can be given that any additional financing will be made available to us or will be available on acceptable terms should such a
need arise.
Off-balance Sheet Arrangements
We do not use special purpose entities or other off-balance sheet
financing techniques, except for operating leases, that we believe have, or are reasonably likely to have, a current or future
material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity,
or capital resources.